NOAEL Studies Cosmetic Ingredient

O-PHENYLPHENOL NOAEL Studies

CAS: 90-43-7

Raw No Observed Adverse Effect Level endpoint records grouped by source. This page does not render calculated Margin of Safety values.

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California Proposition 65 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
California Proposition 65 California Proposition 65 listing ABcancer listing type - - 2000-08-04 California Proposition 65 listing {"cancer_reproductive":"cancer","listed_date":"2000-08-04","listing_mechanism":"AB","madl":null,"nsrl":null,"source_table":"prop65_listings"}
California Proposition 65 California Proposition 65 listing ABcancer listing type - - 2000-08-04 California Proposition 65 listing {"cancer_reproductive":"cancer","listed_date":"2000-08-04","listing_mechanism":"AB","madl":null,"nsrl":null,"source_table":"prop65_listings"}
California Proposition 65 California Proposition 65 listing ABcancer listing type - - 2000-08-04 California Proposition 65 listing {"cancer_reproductive":"cancer","listed_date":"2000-08-04","listing_mechanism":"AB","madl":null,"nsrl":null,"source_table":"prop65_listings"}
California Proposition 65 California Proposition 65 listing ABcancer listing type - - 2000-08-04 California Proposition 65 listing {"cancer_reproductive":"cancer","listed_date":"2000-08-04","listing_mechanism":"AB","madl":null,"nsrl":null,"source_table":"prop65_listings"}
EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx 3 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx NOAEL =100 mg/kg bw/day Rabbit - - reproduction toxicity EFSA - 2009 - OutputID 1173 - body weight - systemic - Peer review of the pesticide risk assessment of the active substance 2-phenylphenol - doi:10.2903/j.efsa.2009.217r
EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx NOAEL =500 mg/kg bw/day Rat - - reproduction toxicity EFSA - 2009 - OutputID 1173 - reproductive - Peer review of the pesticide risk assessment of the active substance 2-phenylphenol - doi:10.2903/j.efsa.2009.217r
EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx NOAEL =39 mg/kg bw/day Rat oral: unspecified 730 days chronic/long term toxicity EFSA - 2009 - OutputID 1173 - histopathology neoplastic - systemic - Peer review of the pesticide risk assessment of the active substance 2-phenylphenol - doi:10.2903/j.efsa.2009.217r
EFSA_OpenFoodTox_EFSA_ReferenceValues.xlsx 2 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
EFSA_OpenFoodTox_EFSA_ReferenceValues.xlsx ADI =0.4 mg/kg bw/day Consumers - - ADI EFSA - 2009 - OutputID 1173 - Consumers - Peer review of the pesticide risk assessment of the active substance 2-phenylphenol - doi:10.2903/j.efsa.2009.217r
EFSA_OpenFoodTox_EFSA_ReferenceValues.xlsx ADI =0.4 mg/kg bw/day Consumers - - ADI EFSA - 2009 - OutputID 1173 - Consumers - Peer review of the pesticide risk assessment of the active substance 2-phenylphenol - doi:10.2903/j.efsa.2009.217r
IARC Monographs 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
IARC Monographs IARC carcinogenicity classification 3 IARC group - - 1998 IARC Monographs {"additional_info":"volume_publication_year=1999","evaluation_year":1998,"source_table":"iarc_classifications","volume":"73"}
INCHEM_WHO_jmpr_jmpmono_v85pr14 2 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
INCHEM_WHO_jmpr_jmpmono_v85pr14 ADI range:0-0.020.02 mg/kg bw/day - - - Health guidance value document_id=jmpr_jmpmono_v85pr14; title=729. Phenylphenol, 2- and its sodium salt (Pesticide residues in food: 1985 evaluations Part II Toxicology); path=mirror/documents/jmpr/jmpmono/v85pr14.htm; row_hash=4dac8100e487cd7b; raw_unit=mg/kg b.w.; context=ESTIMATE OF TEMPORARY ACCEPTABLE DAILY INTAKE FOR MAN 0-0.02 mg/kg b.w.
INCHEM_WHO_jmpr_jmpmono_v85pr14 ADI range:0-0.020.02 mg/kg bw/day - - - Health guidance value document_id=jmpr_jmpmono_v85pr14; title=729. Phenylphenol, 2- and its sodium salt (Pesticide residues in food: 1985 evaluations Part II Toxicology); path=mirror/documents/jmpr/jmpmono/v85pr14.htm; row_hash=4dac8100e487cd7b; raw_unit=mg/kg b.w.; context=ESTIMATE OF TEMPORARY ACCEPTABLE DAILY INTAKE FOR MAN 0-0.02 mg/kg b.w.
INCHEM_WHO_jmpr_jmpmono_v99pr08 64 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
INCHEM_WHO_jmpr_jmpmono_v99pr08 ADI range:0-0.020.02 mg/kg bw/day - - - Health guidance value document_id=jmpr_jmpmono_v99pr08; title=Toxicological evaluations; path=mirror/documents/jmpr/jmpmono/v99pr08.htm; row_hash=76fc70a1a7270171; raw_unit=mg/kg bw; context=A temporary ADI of 0-0.02 mg/kg bw was allocated in 1983, which was extended in 1985 and 1989.
INCHEM_WHO_jmpr_jmpmono_v99pr08 ADI range:0-0.40.4 mg/kg bw/day Rat - 2-year Health guidance value document_id=jmpr_jmpmono_v99pr08; title=Toxicological evaluations; path=mirror/documents/jmpr/jmpmono/v99pr08.htm; row_hash=e8fd575f6e716261; raw_unit=mg/kg bw; context=The Meeting established an ADI of 0-0.4 mg/kg bw for 2-phenylphenol, on the basis of the NOAEL of 39 mg/kg per day in the 2-year study of toxicity (based on decreased body-weight gain and hyperplasia of the urinary bladder) and carcinogenicity of the urinary bladder in male rats and a safety factor of 100.
INCHEM_WHO_jmpr_jmpmono_v99pr08 ADI range:0-0.020.02 mg/kg bw/day - - - Health guidance value document_id=jmpr_jmpmono_v99pr08; title=Toxicological evaluations; path=mirror/documents/jmpr/jmpmono/v99pr08.htm; row_hash=76fc70a1a7270171; raw_unit=mg/kg bw; context=A temporary ADI of 0-0.02 mg/kg bw was allocated in 1983, which was extended in 1985 and 1989.
INCHEM_WHO_jmpr_jmpmono_v99pr08 ADI range:0-0.40.4 mg/kg bw/day Rat - 2-year Health guidance value document_id=jmpr_jmpmono_v99pr08; title=Toxicological evaluations; path=mirror/documents/jmpr/jmpmono/v99pr08.htm; row_hash=e8fd575f6e716261; raw_unit=mg/kg bw; context=The Meeting established an ADI of 0-0.4 mg/kg bw for 2-phenylphenol, on the basis of the NOAEL of 39 mg/kg per day in the 2-year study of toxicity (based on decreased body-weight gain and hyperplasia of the urinary bladder) and carcinogenicity of the urinary bladder in male rats and a safety factor of 100.
INCHEM_WHO_jmpr_jmpmono_v99pr08 ADI range:0-0.020.02 mg/kg bw/day - - - Health guidance value document_id=jmpr_jmpmono_v99pr08; title=Toxicological evaluations; path=mirror/documents/jmpr/jmpmono/v99pr08.htm; row_hash=76fc70a1a7270171; raw_unit=mg/kg bw; context=A temporary ADI of 0-0.02 mg/kg bw was allocated in 1983, which was extended in 1985 and 1989.
INCHEM_WHO_jmpr_jmpmono_v99pr08 ADI range:0-0.40.4 mg/kg bw/day Rat - 2-year Health guidance value document_id=jmpr_jmpmono_v99pr08; title=Toxicological evaluations; path=mirror/documents/jmpr/jmpmono/v99pr08.htm; row_hash=e8fd575f6e716261; raw_unit=mg/kg bw; context=The Meeting established an ADI of 0-0.4 mg/kg bw for 2-phenylphenol, on the basis of the NOAEL of 39 mg/kg per day in the 2-year study of toxicity (based on decreased body-weight gain and hyperplasia of the urinary bladder) and carcinogenicity of the urinary bladder in male rats and a safety factor of 100.
INCHEM_WHO_jmpr_jmpmono_v99pr08 ADI range:0-0.020.02 mg/kg bw/day - - - Health guidance value document_id=jmpr_jmpmono_v99pr08; title=Toxicological evaluations; path=mirror/documents/jmpr/jmpmono/v99pr08.htm; row_hash=76fc70a1a7270171; raw_unit=mg/kg bw; context=A temporary ADI of 0-0.02 mg/kg bw was allocated in 1983, which was extended in 1985 and 1989.
INCHEM_WHO_jmpr_jmpmono_v99pr08 ADI range:0-0.40.4 mg/kg bw/day Rat - 2-year Health guidance value document_id=jmpr_jmpmono_v99pr08; title=Toxicological evaluations; path=mirror/documents/jmpr/jmpmono/v99pr08.htm; row_hash=e8fd575f6e716261; raw_unit=mg/kg bw; context=The Meeting established an ADI of 0-0.4 mg/kg bw for 2-phenylphenol, on the basis of the NOAEL of 39 mg/kg per day in the 2-year study of toxicity (based on decreased body-weight gain and hyperplasia of the urinary bladder) and carcinogenicity of the urinary bladder in male rats and a safety factor of 100.
INCHEM_WHO_jmpr_jmpmono_v99pr08 NOAEL =760 mg/kg bw/day - - - Toxicology study document_id=jmpr_jmpmono_v99pr08; title=Toxicological evaluations; path=mirror/documents/jmpr/jmpmono/v99pr08.htm; row_hash=23a7d3ef1d6196c7; raw_unit=mg/kg bw per day; context=The NOAEL was 6300 ppm, equal to 760 mg/kg bw per day, on the basis of reduced body weight and body-weight gain at 13 000 ppm (Iguchi et al., 1984).
INCHEM_WHO_jmpr_jmpmono_v99pr08 NOAEL =300 mg/kg bw/day - - - Toxicology study document_id=jmpr_jmpmono_v99pr08; title=Toxicological evaluations; path=mirror/documents/jmpr/jmpmono/v99pr08.htm; row_hash=d8cea569b34d850f; raw_unit=mg/kg bw per day; context=The NOAEL was 300 mg/kg bw per day (Cosse et al., 1990).
INCHEM_WHO_jmpr_jmpmono_v99pr08 NOAEL =550 mg/kg bw/day - - - Toxicology study document_id=jmpr_jmpmono_v99pr08; title=Toxicological evaluations; path=mirror/documents/jmpr/jmpmono/v99pr08.htm; row_hash=7d51123515cc5aba; raw_unit=mg/kg bw per day; context=The NOAEL was 5000 ppm, equivalent to 550 mg/kg bw per day, on the basis of reduced body-weight gain and increased relative liver weight at 10 000 ppm (Shibata et al., 1985).
INCHEM_WHO_jmpr_jmpmono_v99pr08 NOAEL =180 mg/kg bw/day - - - Toxicology study document_id=jmpr_jmpmono_v99pr08; title=Toxicological evaluations; path=mirror/documents/jmpr/jmpmono/v99pr08.htm; row_hash=e08e4ec9b84fda5a; raw_unit=mg/kg bw per day; context=The NOAEL was 2500 ppm, equal to 180 mg/kg bw per day, on the basis of reduced body-weight gain at 5000 ppm (Iguchi et al., 1979;
INCHEM_WHO_jmpr_jmpmono_v99pr08 NOAEL =250 mg/kg bw/day - - - Carcinogenicity document_id=jmpr_jmpmono_v99pr08; title=Toxicological evaluations; path=mirror/documents/jmpr/jmpmono/v99pr08.htm; row_hash=b4c6208030a21267; raw_unit=mg/kg bw per day; context=The NOAEL for carcinogenicity was 250 mg/kg bw per day on the basis of an increased incidence of hepatocellular adenomas at 500 mg/kg bw per day (Quast & McGuirk, 1995).
INCHEM_WHO_jmpr_jmpmono_v99pr08 NOAEL =39 mg/kg bw/day - - - Toxicology study document_id=jmpr_jmpmono_v99pr08; title=Toxicological evaluations; path=mirror/documents/jmpr/jmpmono/v99pr08.htm; row_hash=19219f39bd545aa0; raw_unit=mg/kg bw per day; context=The NOAEL for toxicity was 800 ppm, equal to 39 mg/kg bw per day, on the basis of reduced body-weight gain and hyperplasia in the urinary bladder at all doses.
INCHEM_WHO_jmpr_jmpmono_v99pr08 NOAEL =3000 mg/kg bw/day - - - Carcinogenicity document_id=jmpr_jmpmono_v99pr08; title=Toxicological evaluations; path=mirror/documents/jmpr/jmpmono/v99pr08.htm; row_hash=5d2c3b0f19b5d68b; raw_unit=mg/kg bw per day; context=The NOAEL for carcinogenicity was 20 000 ppm, equal to 3000 mg/kg bw per day, the highest dose tested (Ito, 1983a;
INCHEM_WHO_jmpr_jmpmono_v99pr08 NOAEL =270 mg/kg bw/day - - - Carcinogenicity document_id=jmpr_jmpmono_v99pr08; title=Toxicological evaluations; path=mirror/documents/jmpr/jmpmono/v99pr08.htm; row_hash=3c0409dcfb8c1249; raw_unit=mg/kg bw per day; context=The NOAEL was 2500 ppm, equivalent to 270 mg/kg bw per day, on the basis of the increased incidence of urinary bladder tumours (Hiraga & Fujii, 1981).
INCHEM_WHO_jmpr_jmpmono_v99pr08 NOAEL =95 mg/kg bw/day - - - Carcinogenicity document_id=jmpr_jmpmono_v99pr08; title=Toxicological evaluations; path=mirror/documents/jmpr/jmpmono/v99pr08.htm; row_hash=a309c1323e0048a8; raw_unit=mg/kg bw per day; context=The NOAEL was 2500 ppm, equal to 95 mg/kg bw per day, on the basis of urinary bladder tumours at all doses (Hiraga, 1983b;
INCHEM_WHO_jmpr_jmpmono_v99pr08 NOAEL =460 mg/kg bw/day - - - Reproductive toxicity document_id=jmpr_jmpmono_v99pr08; title=Toxicological evaluations; path=mirror/documents/jmpr/jmpmono/v99pr08.htm; row_hash=c900008bf6056cc8; raw_unit=mg/kg bw per day; context=The NOAEL for reproductive toxicity was 460 mg/kg bw per day and that for carcinogenicity was 36 mg/kg bw per day (Eigenberg, 1990).
INCHEM_WHO_jmpr_jmpmono_v99pr08 NOAEL =92 mg/kg bw/day Mouse - - Developmental toxicity document_id=jmpr_jmpmono_v99pr08; title=Toxicological evaluations; path=mirror/documents/jmpr/jmpmono/v99pr08.htm; row_hash=027f3eeecd940b7c; raw_unit=mg/kg bw per day; context=The NOAEL for systemic and developmental toxicity was 92 mg/kg bw per day, on the basis of decreased body weight and morphological lesions in the kidneys, urinary bladder, and ureter and a decrease in pup body weight (Eigenberg, 1995). (ii) Developmental toxicity 2-Phenylphenol and sodium 2-phenylphenol Mice Groups of 20-21 pregnan
INCHEM_WHO_jmpr_jmpmono_v99pr08 NOAEL =2100 mg/kg bw/day - - - Developmental toxicity document_id=jmpr_jmpmono_v99pr08; title=Toxicological evaluations; path=mirror/documents/jmpr/jmpmono/v99pr08.htm; row_hash=14b62229d1247e7b; raw_unit=mg/kg bw per day; context=The NOAEL for developmental toxicity was 2100 mg/kg bw per day, the highest dose tested.
INCHEM_WHO_jmpr_jmpmono_v99pr08 NOAEL =100 mg/kg bw/day - - - Developmental toxicity document_id=jmpr_jmpmono_v99pr08; title=Toxicological evaluations; path=mirror/documents/jmpr/jmpmono/v99pr08.htm; row_hash=ed04f24cabe2434b; raw_unit=mg/kg bw per day; context=The NOAEL was 100 mg/kg bw per day for fetotoxicity and 400 mg/kg bw per day, the highest dose tested, for developmental toxicity (Ogata et al., 1978).
INCHEM_WHO_jmpr_jmpmono_v99pr08 NOAEL =150 mg/kg bw/day - - - Developmental toxicity document_id=jmpr_jmpmono_v99pr08; title=Toxicological evaluations; path=mirror/documents/jmpr/jmpmono/v99pr08.htm; row_hash=49f26599ffd868dc; raw_unit=mg/kg bw per day; context=The NOAEL was 150 mg/kg bw per day for maternal toxicity, 300 mg/kg bw per day for fetotoxicity, and 600 mg/kg bw per day, the highest dose tested, for developmental toxicity (Kaneda et al., 1978).
INCHEM_WHO_jmpr_jmpmono_v99pr08 NOAEL =760 mg/kg bw/day - - - Toxicology study document_id=jmpr_jmpmono_v99pr08; title=Toxicological evaluations; path=mirror/documents/jmpr/jmpmono/v99pr08.htm; row_hash=23a7d3ef1d6196c7; raw_unit=mg/kg bw per day; context=The NOAEL was 6300 ppm, equal to 760 mg/kg bw per day, on the basis of reduced body weight and body-weight gain at 13 000 ppm (Iguchi et al., 1984).
INCHEM_WHO_jmpr_jmpmono_v99pr08 NOAEL =300 mg/kg bw/day - - - Toxicology study document_id=jmpr_jmpmono_v99pr08; title=Toxicological evaluations; path=mirror/documents/jmpr/jmpmono/v99pr08.htm; row_hash=d8cea569b34d850f; raw_unit=mg/kg bw per day; context=The NOAEL was 300 mg/kg bw per day (Cosse et al., 1990).
INCHEM_WHO_jmpr_jmpmono_v99pr08 NOAEL =550 mg/kg bw/day - - - Toxicology study document_id=jmpr_jmpmono_v99pr08; title=Toxicological evaluations; path=mirror/documents/jmpr/jmpmono/v99pr08.htm; row_hash=7d51123515cc5aba; raw_unit=mg/kg bw per day; context=The NOAEL was 5000 ppm, equivalent to 550 mg/kg bw per day, on the basis of reduced body-weight gain and increased relative liver weight at 10 000 ppm (Shibata et al., 1985).
INCHEM_WHO_jmpr_jmpmono_v99pr08 NOAEL =180 mg/kg bw/day - - - Toxicology study document_id=jmpr_jmpmono_v99pr08; title=Toxicological evaluations; path=mirror/documents/jmpr/jmpmono/v99pr08.htm; row_hash=e08e4ec9b84fda5a; raw_unit=mg/kg bw per day; context=The NOAEL was 2500 ppm, equal to 180 mg/kg bw per day, on the basis of reduced body-weight gain at 5000 ppm (Iguchi et al., 1979;
INCHEM_WHO_jmpr_jmpmono_v99pr08 NOAEL =250 mg/kg bw/day - - - Carcinogenicity document_id=jmpr_jmpmono_v99pr08; title=Toxicological evaluations; path=mirror/documents/jmpr/jmpmono/v99pr08.htm; row_hash=b4c6208030a21267; raw_unit=mg/kg bw per day; context=The NOAEL for carcinogenicity was 250 mg/kg bw per day on the basis of an increased incidence of hepatocellular adenomas at 500 mg/kg bw per day (Quast & McGuirk, 1995).
INCHEM_WHO_jmpr_jmpmono_v99pr08 NOAEL =39 mg/kg bw/day - - - Toxicology study document_id=jmpr_jmpmono_v99pr08; title=Toxicological evaluations; path=mirror/documents/jmpr/jmpmono/v99pr08.htm; row_hash=19219f39bd545aa0; raw_unit=mg/kg bw per day; context=The NOAEL for toxicity was 800 ppm, equal to 39 mg/kg bw per day, on the basis of reduced body-weight gain and hyperplasia in the urinary bladder at all doses.
INCHEM_WHO_jmpr_jmpmono_v99pr08 NOAEL =3000 mg/kg bw/day - - - Carcinogenicity document_id=jmpr_jmpmono_v99pr08; title=Toxicological evaluations; path=mirror/documents/jmpr/jmpmono/v99pr08.htm; row_hash=5d2c3b0f19b5d68b; raw_unit=mg/kg bw per day; context=The NOAEL for carcinogenicity was 20 000 ppm, equal to 3000 mg/kg bw per day, the highest dose tested (Ito, 1983a;
INCHEM_WHO_jmpr_jmpmono_v99pr08 NOAEL =270 mg/kg bw/day - - - Carcinogenicity document_id=jmpr_jmpmono_v99pr08; title=Toxicological evaluations; path=mirror/documents/jmpr/jmpmono/v99pr08.htm; row_hash=3c0409dcfb8c1249; raw_unit=mg/kg bw per day; context=The NOAEL was 2500 ppm, equivalent to 270 mg/kg bw per day, on the basis of the increased incidence of urinary bladder tumours (Hiraga & Fujii, 1981).
INCHEM_WHO_jmpr_jmpmono_v99pr08 NOAEL =95 mg/kg bw/day - - - Carcinogenicity document_id=jmpr_jmpmono_v99pr08; title=Toxicological evaluations; path=mirror/documents/jmpr/jmpmono/v99pr08.htm; row_hash=a309c1323e0048a8; raw_unit=mg/kg bw per day; context=The NOAEL was 2500 ppm, equal to 95 mg/kg bw per day, on the basis of urinary bladder tumours at all doses (Hiraga, 1983b;
INCHEM_WHO_jmpr_jmpmono_v99pr08 NOAEL =460 mg/kg bw/day - - - Reproductive toxicity document_id=jmpr_jmpmono_v99pr08; title=Toxicological evaluations; path=mirror/documents/jmpr/jmpmono/v99pr08.htm; row_hash=c900008bf6056cc8; raw_unit=mg/kg bw per day; context=The NOAEL for reproductive toxicity was 460 mg/kg bw per day and that for carcinogenicity was 36 mg/kg bw per day (Eigenberg, 1990).
INCHEM_WHO_jmpr_jmpmono_v99pr08 NOAEL =92 mg/kg bw/day Mouse - - Developmental toxicity document_id=jmpr_jmpmono_v99pr08; title=Toxicological evaluations; path=mirror/documents/jmpr/jmpmono/v99pr08.htm; row_hash=027f3eeecd940b7c; raw_unit=mg/kg bw per day; context=The NOAEL for systemic and developmental toxicity was 92 mg/kg bw per day, on the basis of decreased body weight and morphological lesions in the kidneys, urinary bladder, and ureter and a decrease in pup body weight (Eigenberg, 1995). (ii) Developmental toxicity 2-Phenylphenol and sodium 2-phenylphenol Mice Groups of 20-21 pregnan
INCHEM_WHO_jmpr_jmpmono_v99pr08 NOAEL =2100 mg/kg bw/day - - - Developmental toxicity document_id=jmpr_jmpmono_v99pr08; title=Toxicological evaluations; path=mirror/documents/jmpr/jmpmono/v99pr08.htm; row_hash=14b62229d1247e7b; raw_unit=mg/kg bw per day; context=The NOAEL for developmental toxicity was 2100 mg/kg bw per day, the highest dose tested.
INCHEM_WHO_jmpr_jmpmono_v99pr08 NOAEL =100 mg/kg bw/day - - - Developmental toxicity document_id=jmpr_jmpmono_v99pr08; title=Toxicological evaluations; path=mirror/documents/jmpr/jmpmono/v99pr08.htm; row_hash=ed04f24cabe2434b; raw_unit=mg/kg bw per day; context=The NOAEL was 100 mg/kg bw per day for fetotoxicity and 400 mg/kg bw per day, the highest dose tested, for developmental toxicity (Ogata et al., 1978).
INCHEM_WHO_jmpr_jmpmono_v99pr08 NOAEL =150 mg/kg bw/day - - - Developmental toxicity document_id=jmpr_jmpmono_v99pr08; title=Toxicological evaluations; path=mirror/documents/jmpr/jmpmono/v99pr08.htm; row_hash=49f26599ffd868dc; raw_unit=mg/kg bw per day; context=The NOAEL was 150 mg/kg bw per day for maternal toxicity, 300 mg/kg bw per day for fetotoxicity, and 600 mg/kg bw per day, the highest dose tested, for developmental toxicity (Kaneda et al., 1978).
INCHEM_WHO_jmpr_jmpmono_v99pr08 NOAEL =760 mg/kg bw/day - - - Toxicology study document_id=jmpr_jmpmono_v99pr08; title=Toxicological evaluations; path=mirror/documents/jmpr/jmpmono/v99pr08.htm; row_hash=23a7d3ef1d6196c7; raw_unit=mg/kg bw per day; context=The NOAEL was 6300 ppm, equal to 760 mg/kg bw per day, on the basis of reduced body weight and body-weight gain at 13 000 ppm (Iguchi et al., 1984).
INCHEM_WHO_jmpr_jmpmono_v99pr08 NOAEL =300 mg/kg bw/day - - - Toxicology study document_id=jmpr_jmpmono_v99pr08; title=Toxicological evaluations; path=mirror/documents/jmpr/jmpmono/v99pr08.htm; row_hash=d8cea569b34d850f; raw_unit=mg/kg bw per day; context=The NOAEL was 300 mg/kg bw per day (Cosse et al., 1990).
INCHEM_WHO_jmpr_jmpmono_v99pr08 NOAEL =550 mg/kg bw/day - - - Toxicology study document_id=jmpr_jmpmono_v99pr08; title=Toxicological evaluations; path=mirror/documents/jmpr/jmpmono/v99pr08.htm; row_hash=7d51123515cc5aba; raw_unit=mg/kg bw per day; context=The NOAEL was 5000 ppm, equivalent to 550 mg/kg bw per day, on the basis of reduced body-weight gain and increased relative liver weight at 10 000 ppm (Shibata et al., 1985).
INCHEM_WHO_jmpr_jmpmono_v99pr08 NOAEL =180 mg/kg bw/day - - - Toxicology study document_id=jmpr_jmpmono_v99pr08; title=Toxicological evaluations; path=mirror/documents/jmpr/jmpmono/v99pr08.htm; row_hash=e08e4ec9b84fda5a; raw_unit=mg/kg bw per day; context=The NOAEL was 2500 ppm, equal to 180 mg/kg bw per day, on the basis of reduced body-weight gain at 5000 ppm (Iguchi et al., 1979;
INCHEM_WHO_jmpr_jmpmono_v99pr08 NOAEL =250 mg/kg bw/day - - - Carcinogenicity document_id=jmpr_jmpmono_v99pr08; title=Toxicological evaluations; path=mirror/documents/jmpr/jmpmono/v99pr08.htm; row_hash=b4c6208030a21267; raw_unit=mg/kg bw per day; context=The NOAEL for carcinogenicity was 250 mg/kg bw per day on the basis of an increased incidence of hepatocellular adenomas at 500 mg/kg bw per day (Quast & McGuirk, 1995).
INCHEM_WHO_jmpr_jmpmono_v99pr08 NOAEL =39 mg/kg bw/day - - - Toxicology study document_id=jmpr_jmpmono_v99pr08; title=Toxicological evaluations; path=mirror/documents/jmpr/jmpmono/v99pr08.htm; row_hash=19219f39bd545aa0; raw_unit=mg/kg bw per day; context=The NOAEL for toxicity was 800 ppm, equal to 39 mg/kg bw per day, on the basis of reduced body-weight gain and hyperplasia in the urinary bladder at all doses.
INCHEM_WHO_jmpr_jmpmono_v99pr08 NOAEL =3000 mg/kg bw/day - - - Carcinogenicity document_id=jmpr_jmpmono_v99pr08; title=Toxicological evaluations; path=mirror/documents/jmpr/jmpmono/v99pr08.htm; row_hash=5d2c3b0f19b5d68b; raw_unit=mg/kg bw per day; context=The NOAEL for carcinogenicity was 20 000 ppm, equal to 3000 mg/kg bw per day, the highest dose tested (Ito, 1983a;
INCHEM_WHO_jmpr_jmpmono_v99pr08 NOAEL =270 mg/kg bw/day - - - Carcinogenicity document_id=jmpr_jmpmono_v99pr08; title=Toxicological evaluations; path=mirror/documents/jmpr/jmpmono/v99pr08.htm; row_hash=3c0409dcfb8c1249; raw_unit=mg/kg bw per day; context=The NOAEL was 2500 ppm, equivalent to 270 mg/kg bw per day, on the basis of the increased incidence of urinary bladder tumours (Hiraga & Fujii, 1981).
INCHEM_WHO_jmpr_jmpmono_v99pr08 NOAEL =95 mg/kg bw/day - - - Carcinogenicity document_id=jmpr_jmpmono_v99pr08; title=Toxicological evaluations; path=mirror/documents/jmpr/jmpmono/v99pr08.htm; row_hash=a309c1323e0048a8; raw_unit=mg/kg bw per day; context=The NOAEL was 2500 ppm, equal to 95 mg/kg bw per day, on the basis of urinary bladder tumours at all doses (Hiraga, 1983b;
INCHEM_WHO_jmpr_jmpmono_v99pr08 NOAEL =460 mg/kg bw/day - - - Reproductive toxicity document_id=jmpr_jmpmono_v99pr08; title=Toxicological evaluations; path=mirror/documents/jmpr/jmpmono/v99pr08.htm; row_hash=c900008bf6056cc8; raw_unit=mg/kg bw per day; context=The NOAEL for reproductive toxicity was 460 mg/kg bw per day and that for carcinogenicity was 36 mg/kg bw per day (Eigenberg, 1990).
INCHEM_WHO_jmpr_jmpmono_v99pr08 NOAEL =92 mg/kg bw/day Mouse - - Developmental toxicity document_id=jmpr_jmpmono_v99pr08; title=Toxicological evaluations; path=mirror/documents/jmpr/jmpmono/v99pr08.htm; row_hash=027f3eeecd940b7c; raw_unit=mg/kg bw per day; context=The NOAEL for systemic and developmental toxicity was 92 mg/kg bw per day, on the basis of decreased body weight and morphological lesions in the kidneys, urinary bladder, and ureter and a decrease in pup body weight (Eigenberg, 1995). (ii) Developmental toxicity 2-Phenylphenol and sodium 2-phenylphenol Mice Groups of 20-21 pregnan
INCHEM_WHO_jmpr_jmpmono_v99pr08 NOAEL =2100 mg/kg bw/day - - - Developmental toxicity document_id=jmpr_jmpmono_v99pr08; title=Toxicological evaluations; path=mirror/documents/jmpr/jmpmono/v99pr08.htm; row_hash=14b62229d1247e7b; raw_unit=mg/kg bw per day; context=The NOAEL for developmental toxicity was 2100 mg/kg bw per day, the highest dose tested.
INCHEM_WHO_jmpr_jmpmono_v99pr08 NOAEL =100 mg/kg bw/day - - - Developmental toxicity document_id=jmpr_jmpmono_v99pr08; title=Toxicological evaluations; path=mirror/documents/jmpr/jmpmono/v99pr08.htm; row_hash=ed04f24cabe2434b; raw_unit=mg/kg bw per day; context=The NOAEL was 100 mg/kg bw per day for fetotoxicity and 400 mg/kg bw per day, the highest dose tested, for developmental toxicity (Ogata et al., 1978).
INCHEM_WHO_jmpr_jmpmono_v99pr08 NOAEL =150 mg/kg bw/day - - - Developmental toxicity document_id=jmpr_jmpmono_v99pr08; title=Toxicological evaluations; path=mirror/documents/jmpr/jmpmono/v99pr08.htm; row_hash=49f26599ffd868dc; raw_unit=mg/kg bw per day; context=The NOAEL was 150 mg/kg bw per day for maternal toxicity, 300 mg/kg bw per day for fetotoxicity, and 600 mg/kg bw per day, the highest dose tested, for developmental toxicity (Kaneda et al., 1978).
INCHEM_WHO_jmpr_jmpmono_v99pr08 NOAEL =760 mg/kg bw/day - - - Toxicology study document_id=jmpr_jmpmono_v99pr08; title=Toxicological evaluations; path=mirror/documents/jmpr/jmpmono/v99pr08.htm; row_hash=23a7d3ef1d6196c7; raw_unit=mg/kg bw per day; context=The NOAEL was 6300 ppm, equal to 760 mg/kg bw per day, on the basis of reduced body weight and body-weight gain at 13 000 ppm (Iguchi et al., 1984).
INCHEM_WHO_jmpr_jmpmono_v99pr08 NOAEL =300 mg/kg bw/day - - - Toxicology study document_id=jmpr_jmpmono_v99pr08; title=Toxicological evaluations; path=mirror/documents/jmpr/jmpmono/v99pr08.htm; row_hash=d8cea569b34d850f; raw_unit=mg/kg bw per day; context=The NOAEL was 300 mg/kg bw per day (Cosse et al., 1990).
INCHEM_WHO_jmpr_jmpmono_v99pr08 NOAEL =550 mg/kg bw/day - - - Toxicology study document_id=jmpr_jmpmono_v99pr08; title=Toxicological evaluations; path=mirror/documents/jmpr/jmpmono/v99pr08.htm; row_hash=7d51123515cc5aba; raw_unit=mg/kg bw per day; context=The NOAEL was 5000 ppm, equivalent to 550 mg/kg bw per day, on the basis of reduced body-weight gain and increased relative liver weight at 10 000 ppm (Shibata et al., 1985).
INCHEM_WHO_jmpr_jmpmono_v99pr08 NOAEL =180 mg/kg bw/day - - - Toxicology study document_id=jmpr_jmpmono_v99pr08; title=Toxicological evaluations; path=mirror/documents/jmpr/jmpmono/v99pr08.htm; row_hash=e08e4ec9b84fda5a; raw_unit=mg/kg bw per day; context=The NOAEL was 2500 ppm, equal to 180 mg/kg bw per day, on the basis of reduced body-weight gain at 5000 ppm (Iguchi et al., 1979;
INCHEM_WHO_jmpr_jmpmono_v99pr08 NOAEL =250 mg/kg bw/day - - - Carcinogenicity document_id=jmpr_jmpmono_v99pr08; title=Toxicological evaluations; path=mirror/documents/jmpr/jmpmono/v99pr08.htm; row_hash=b4c6208030a21267; raw_unit=mg/kg bw per day; context=The NOAEL for carcinogenicity was 250 mg/kg bw per day on the basis of an increased incidence of hepatocellular adenomas at 500 mg/kg bw per day (Quast & McGuirk, 1995).
INCHEM_WHO_jmpr_jmpmono_v99pr08 NOAEL =39 mg/kg bw/day - - - Toxicology study document_id=jmpr_jmpmono_v99pr08; title=Toxicological evaluations; path=mirror/documents/jmpr/jmpmono/v99pr08.htm; row_hash=19219f39bd545aa0; raw_unit=mg/kg bw per day; context=The NOAEL for toxicity was 800 ppm, equal to 39 mg/kg bw per day, on the basis of reduced body-weight gain and hyperplasia in the urinary bladder at all doses.
INCHEM_WHO_jmpr_jmpmono_v99pr08 NOAEL =3000 mg/kg bw/day - - - Carcinogenicity document_id=jmpr_jmpmono_v99pr08; title=Toxicological evaluations; path=mirror/documents/jmpr/jmpmono/v99pr08.htm; row_hash=5d2c3b0f19b5d68b; raw_unit=mg/kg bw per day; context=The NOAEL for carcinogenicity was 20 000 ppm, equal to 3000 mg/kg bw per day, the highest dose tested (Ito, 1983a;
INCHEM_WHO_jmpr_jmpmono_v99pr08 NOAEL =270 mg/kg bw/day - - - Carcinogenicity document_id=jmpr_jmpmono_v99pr08; title=Toxicological evaluations; path=mirror/documents/jmpr/jmpmono/v99pr08.htm; row_hash=3c0409dcfb8c1249; raw_unit=mg/kg bw per day; context=The NOAEL was 2500 ppm, equivalent to 270 mg/kg bw per day, on the basis of the increased incidence of urinary bladder tumours (Hiraga & Fujii, 1981).
INCHEM_WHO_jmpr_jmpmono_v99pr08 NOAEL =95 mg/kg bw/day - - - Carcinogenicity document_id=jmpr_jmpmono_v99pr08; title=Toxicological evaluations; path=mirror/documents/jmpr/jmpmono/v99pr08.htm; row_hash=a309c1323e0048a8; raw_unit=mg/kg bw per day; context=The NOAEL was 2500 ppm, equal to 95 mg/kg bw per day, on the basis of urinary bladder tumours at all doses (Hiraga, 1983b;
INCHEM_WHO_jmpr_jmpmono_v99pr08 NOAEL =460 mg/kg bw/day - - - Reproductive toxicity document_id=jmpr_jmpmono_v99pr08; title=Toxicological evaluations; path=mirror/documents/jmpr/jmpmono/v99pr08.htm; row_hash=c900008bf6056cc8; raw_unit=mg/kg bw per day; context=The NOAEL for reproductive toxicity was 460 mg/kg bw per day and that for carcinogenicity was 36 mg/kg bw per day (Eigenberg, 1990).
INCHEM_WHO_jmpr_jmpmono_v99pr08 NOAEL =92 mg/kg bw/day Mouse - - Developmental toxicity document_id=jmpr_jmpmono_v99pr08; title=Toxicological evaluations; path=mirror/documents/jmpr/jmpmono/v99pr08.htm; row_hash=027f3eeecd940b7c; raw_unit=mg/kg bw per day; context=The NOAEL for systemic and developmental toxicity was 92 mg/kg bw per day, on the basis of decreased body weight and morphological lesions in the kidneys, urinary bladder, and ureter and a decrease in pup body weight (Eigenberg, 1995). (ii) Developmental toxicity 2-Phenylphenol and sodium 2-phenylphenol Mice Groups of 20-21 pregnan
INCHEM_WHO_jmpr_jmpmono_v99pr08 NOAEL =2100 mg/kg bw/day - - - Developmental toxicity document_id=jmpr_jmpmono_v99pr08; title=Toxicological evaluations; path=mirror/documents/jmpr/jmpmono/v99pr08.htm; row_hash=14b62229d1247e7b; raw_unit=mg/kg bw per day; context=The NOAEL for developmental toxicity was 2100 mg/kg bw per day, the highest dose tested.
INCHEM_WHO_jmpr_jmpmono_v99pr08 NOAEL =100 mg/kg bw/day - - - Developmental toxicity document_id=jmpr_jmpmono_v99pr08; title=Toxicological evaluations; path=mirror/documents/jmpr/jmpmono/v99pr08.htm; row_hash=ed04f24cabe2434b; raw_unit=mg/kg bw per day; context=The NOAEL was 100 mg/kg bw per day for fetotoxicity and 400 mg/kg bw per day, the highest dose tested, for developmental toxicity (Ogata et al., 1978).
INCHEM_WHO_jmpr_jmpmono_v99pr08 NOAEL =150 mg/kg bw/day - - - Developmental toxicity document_id=jmpr_jmpmono_v99pr08; title=Toxicological evaluations; path=mirror/documents/jmpr/jmpmono/v99pr08.htm; row_hash=49f26599ffd868dc; raw_unit=mg/kg bw per day; context=The NOAEL was 150 mg/kg bw per day for maternal toxicity, 300 mg/kg bw per day for fetotoxicity, and 600 mg/kg bw per day, the highest dose tested, for developmental toxicity (Kaneda et al., 1978).
NTP_ICE_acute_dermal 5 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
NTP_ICE_acute_dermal EPA classification 4 unitless Rat Dermal - In Vivo; Rat Acute Dermal Toxicity sheet=Data; excel_row=668; Record_ID=acute_dermal_96; Data_Type=In Vivo; Formulation_ID=MIX95; Formulation_Name=Chemsico Aerosol LEG; Percent_Active_Ingredient=0.1; Mixture=Mixture; DTXSID=DTXSID2021151; Assay=Rat Acute Dermal Toxicity; Endpoint=EPA classification; Response=4.0; Response_Unit=Unitless; Species=Rat; Route=Dermal; Reference=FIFRA data; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2021151; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID2021151
NTP_ICE_acute_dermal EPA classification 3 unitless Rat Dermal - In Vivo; Rat Acute Dermal Toxicity sheet=Data; excel_row=673; Record_ID=acute_dermal_527; Data_Type=In Vivo; Formulation_ID=MIX520; Formulation_Name=Veriguard OD; Percent_Active_Ingredient=15.0; Mixture=Mixture; DTXSID=DTXSID2021151; Assay=Rat Acute Dermal Toxicity; Endpoint=EPA classification; Response=3.0; Response_Unit=Unitless; Species=Rat; Route=Dermal; Reference=FIFRA data; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2021151; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID2021151
NTP_ICE_acute_dermal GHS classification 5 unitless Rat Dermal - In Vivo; Rat Acute Dermal Toxicity sheet=Data; excel_row=664; Record_ID=acute_dermal_312; Data_Type=In Vivo; Formulation_ID=MIX305; Formulation_Name=Mediclean Carpet Sanitizer; Percent_Active_Ingredient=4.02; Mixture=Mixture; DTXSID=DTXSID2021151; Assay=Rat Acute Dermal Toxicity; Endpoint=GHS classification; Response=5.0; Response_Unit=Unitless; Species=Rat; Route=Dermal; Reference=FIFRA data; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2021151; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID2021151
NTP_ICE_acute_dermal LD50 >2000 mg/kg Rat Dermal - In Vivo; Rat Acute Dermal Toxicity sheet=Data; excel_row=667; Record_ID=acute_dermal_527; Data_Type=In Vivo; Formulation_ID=MIX520; Formulation_Name=Veriguard OD; Percent_Active_Ingredient=15.0; Mixture=Mixture; DTXSID=DTXSID2021151; Assay=Rat Acute Dermal Toxicity; Endpoint=LD50; Response_Modifier=>; Response=2000.0; Response_Unit=mg/kg; Species=Rat; Route=Dermal; Reference=FIFRA data; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2021151; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID2021151
NTP_ICE_acute_dermal LD50 >5000 mg/kg Rat Dermal - In Vivo; Rat Acute Dermal Toxicity sheet=Data; excel_row=669; Record_ID=acute_dermal_96; Data_Type=In Vivo; Formulation_ID=MIX95; Formulation_Name=Chemsico Aerosol LEG; Percent_Active_Ingredient=0.1; Mixture=Mixture; DTXSID=DTXSID2021151; Assay=Rat Acute Dermal Toxicity; Endpoint=LD50; Response_Modifier=>; Response=5000.0; Response_Unit=mg/kg; Species=Rat; Route=Dermal; Reference=FIFRA data; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2021151; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID2021151
NTP_ICE_acute_inhalation 7 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
NTP_ICE_acute_inhalation EPA Classification 4 unitless - Inhalation - In Vivo; AcuteInhal6pack; Rat Acute Inhalation Toxicity sheet=Data; excel_row=1349; Record_ID=acute_inhalation_440; Data_Type=In Vivo; Internal_Data_Source=AcuteInhal6pack; Formulation_ID=MIX520; Formulation_Name=Veriguard OD; Percent_Active_Ingredient=15.0; Mixture=Mixture; DTXSID=DTXSID2021151; Assay=Rat Acute Inhalation Toxicity; Endpoint=EPA Classification; Response=4; Response_Unit=Unitless; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2021151; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID2021151
NTP_ICE_acute_inhalation EPA Classification 3 unitless - Inhalation - In Vivo; AcuteInhal6pack; Rat Acute Inhalation Toxicity sheet=Data; excel_row=1360; Record_ID=acute_inhalation_298; Data_Type=In Vivo; Internal_Data_Source=AcuteInhal6pack; Formulation_ID=MIX378; Formulation_Name=Raid Ant & Roach Killer with Germ Kill CIK; Percent_Active_Ingredient=0.1; Mixture=Mixture; DTXSID=DTXSID2021151; Assay=Rat Acute Inhalation Toxicity; Endpoint=EPA Classification; Response=3; Response_Unit=Unitless; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2021151; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID2021151
NTP_ICE_acute_inhalation LC50 >0.036 mg/L - Inhalation Duration=4 hr In Vivo; AcuteInhalNICEATM; Rat Acute Inhalation Toxicity sheet=Data; excel_row=1348; Record_ID=acute_inhalation_1083; Data_Type=In Vivo; Internal_Data_Source=AcuteInhalNICEATM; Mixture=Chemical; DTXSID=DTXSID2021151; Assay=Rat Acute Inhalation Toxicity; Endpoint=LC50; Response_Modifier=>; Response=0.036; Response_Unit=mg/L; Reference=REACH; URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/2168/7/3/3/?documentUUID=2c055818-6ebe-445b-a148-666d8d7f478a; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2021151; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID2021151
NTP_ICE_acute_inhalation LC50 2.09 mg/L - Inhalation - In Vivo; AcuteInhal6pack; Rat Acute Inhalation Toxicity sheet=Data; excel_row=1354; Record_ID=acute_inhalation_300; Data_Type=In Vivo; Internal_Data_Source=AcuteInhal6pack; Formulation_ID=MIX378; Formulation_Name=Raid Ant & Roach Killer with Germ Kill CIK; Percent_Active_Ingredient=0.1; Mixture=Mixture; DTXSID=DTXSID2021151; Assay=Rat Acute Inhalation Toxicity; Endpoint=LC50; Response=2.09; Response_Unit=mg/L; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2021151; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID2021151
NTP_ICE_acute_inhalation LC50 >2.1 mg/L - Inhalation - In Vivo; AcuteInhal6pack; Rat Acute Inhalation Toxicity sheet=Data; excel_row=1355; Record_ID=acute_inhalation_440; Data_Type=In Vivo; Internal_Data_Source=AcuteInhal6pack; Formulation_ID=MIX520; Formulation_Name=Veriguard OD; Percent_Active_Ingredient=15.0; Mixture=Mixture; DTXSID=DTXSID2021151; Assay=Rat Acute Inhalation Toxicity; Endpoint=LC50; Response_Modifier=>; Response=2.1; Response_Unit=mg/L; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2021151; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID2021151
NTP_ICE_acute_inhalation LC50 >0.949 mg/L - Inhalation Duration=1 hr In Vivo; AcuteInhalNICEATM; Rat Acute Inhalation Toxicity sheet=Data; excel_row=1357; Record_ID=acute_inhalation_1081; Data_Type=In Vivo; Internal_Data_Source=AcuteInhalNICEATM; Mixture=Chemical; DTXSID=DTXSID2021151; Assay=Rat Acute Inhalation Toxicity; Endpoint=LC50; Response_Modifier=>; Response=0.949; Response_Unit=mg/L; Reference=REACH; URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/2168/7/3/3/?documentUUID=1450d78a-7992-4513-94af-13e0de39c659; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2021151; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID2021151
NTP_ICE_acute_inhalation LC50 2.16 mg/L - Inhalation - In Vivo; AcuteInhal6pack; Rat Acute Inhalation Toxicity sheet=Data; excel_row=1358; Record_ID=acute_inhalation_491; Data_Type=In Vivo; Internal_Data_Source=AcuteInhal6pack; Formulation_ID=MIX95; Formulation_Name=Chemsico Aerosol LEG; Percent_Active_Ingredient=0.1; Mixture=Mixture; DTXSID=DTXSID2021151; Assay=Rat Acute Inhalation Toxicity; Endpoint=LC50; Response=2.16; Response_Unit=mg/L; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2021151; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID2021151
NTP_ICE_acute_oral 19 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
NTP_ICE_acute_oral EPA classification =3 Unitless Rat (Female) oral acute Rat Acute Oral Toxicity Studies submitted to EPA in support of pesticide registration applications (undated); record_id=acute_oral_12720; row=3857; data_type=In Vivo; mixture=Mixture; formulation_id=MIX305; formulation_name=Mediclean Carpet Sanitizer; chemical_name=2-Phenylphenol; preferred_name=2-Phenylphenol; percent_active_ingredient=4.02; dtxsid=DTXSID2021151; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2021151; url_cebs=https://doi.org/10.22427/NTP-DATA-DTXSID2021151; source_file=acute_oral.xlsx
NTP_ICE_acute_oral EPA classification =4 Unitless Rat (Female) oral acute Rat Acute Oral Toxicity Studies submitted to EPA in support of pesticide registration applications (undated); record_id=acute_oral_12345; row=3866; data_type=In Vivo; mixture=Mixture; formulation_id=MIX95; formulation_name=Chemsico Aerosol LEG; chemical_name=2-Phenylphenol; preferred_name=2-Phenylphenol; percent_active_ingredient=0.1; dtxsid=DTXSID2021151; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2021151; url_cebs=https://doi.org/10.22427/NTP-DATA-DTXSID2021151; source_file=acute_oral.xlsx
NTP_ICE_acute_oral EPA classification =4 Unitless Rat (Male) oral acute Rat Acute Oral Toxicity Studies submitted to EPA in support of pesticide registration applications (undated); record_id=acute_oral_12878; row=3872; data_type=In Vivo; mixture=Mixture; formulation_id=MIX378; formulation_name=Raid Ant & Roach Killer with Germ Kill CIK; chemical_name=2-Phenylphenol; preferred_name=2-Phenylphenol; percent_active_ingredient=0.1; dtxsid=DTXSID2021151; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2021151; url_cebs=https://doi.org/10.22427/NTP-DATA-DTXSID2021151; source_file=acute_oral.xlsx
NTP_ICE_acute_oral EPA classification =3 Unitless Rat (Female) oral acute Rat Acute Oral Toxicity Studies submitted to EPA in support of pesticide registration applications (undated); record_id=acute_oral_12825; row=3875; data_type=In Vivo; mixture=Mixture; formulation_id=MIX650; formulation_name=Orthophenylphenol/Sodium Orthophenylphenate; chemical_name=2-Phenylphenol; preferred_name=2-Phenylphenol; percent_active_ingredient=99.9; dtxsid=DTXSID2021151; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2021151; url_cebs=https://doi.org/10.22427/NTP-DATA-DTXSID2021151; source_file=acute_oral.xlsx
NTP_ICE_acute_oral EPA classification =3 Unitless Rat (Female) oral acute Rat Acute Oral Toxicity Studies submitted to EPA in support of pesticide registration applications (undated); record_id=acute_oral_13118; row=3885; data_type=In Vivo; mixture=Mixture; formulation_id=MIX520; formulation_name=Veriguard OD; chemical_name=2-Phenylphenol; preferred_name=2-Phenylphenol; percent_active_ingredient=15.0; dtxsid=DTXSID2021151; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2021151; url_cebs=https://doi.org/10.22427/NTP-DATA-DTXSID2021151; source_file=acute_oral.xlsx
NTP_ICE_acute_oral GHS classification =5 Unitless Rat (Female) oral acute Rat Acute Oral Toxicity Studies submitted to EPA in support of pesticide registration applications (undated); record_id=acute_oral_12345; row=3871; data_type=In Vivo; mixture=Mixture; formulation_id=MIX95; formulation_name=Chemsico Aerosol LEG; chemical_name=2-Phenylphenol; preferred_name=2-Phenylphenol; percent_active_ingredient=0.1; dtxsid=DTXSID2021151; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2021151; url_cebs=https://doi.org/10.22427/NTP-DATA-DTXSID2021151; source_file=acute_oral.xlsx
NTP_ICE_acute_oral GHS classification =5 Unitless Rat (Male) oral acute Rat Acute Oral Toxicity Studies submitted to EPA in support of pesticide registration applications (undated); record_id=acute_oral_12878; row=3876; data_type=In Vivo; mixture=Mixture; formulation_id=MIX378; formulation_name=Raid Ant & Roach Killer with Germ Kill CIK; chemical_name=2-Phenylphenol; preferred_name=2-Phenylphenol; percent_active_ingredient=0.1; dtxsid=DTXSID2021151; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2021151; url_cebs=https://doi.org/10.22427/NTP-DATA-DTXSID2021151; source_file=acute_oral.xlsx
NTP_ICE_acute_oral GHS classification =4 Unitless Rat (Male/Female) oral acute Rat Acute Oral Toxicity Studies submitted to EPA in support of pesticide registration applications (undated); record_id=acute_oral_12820; row=3884; data_type=In Vivo; mixture=Mixture; formulation_id=MIX650; formulation_name=Orthophenylphenol/Sodium Orthophenylphenate; chemical_name=2-Phenylphenol; preferred_name=2-Phenylphenol; percent_active_ingredient=99.9; dtxsid=DTXSID2021151; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2021151; url_cebs=https://doi.org/10.22427/NTP-DATA-DTXSID2021151; source_file=acute_oral.xlsx
NTP_ICE_acute_oral GHS classification =5 Unitless Rat (Male) oral acute Rat Acute Oral Toxicity Studies submitted to EPA in support of pesticide registration applications (undated); record_id=acute_oral_12823; row=3888; data_type=In Vivo; mixture=Mixture; formulation_id=MIX650; formulation_name=Orthophenylphenol/Sodium Orthophenylphenate; chemical_name=2-Phenylphenol; preferred_name=2-Phenylphenol; percent_active_ingredient=99.9; dtxsid=DTXSID2021151; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2021151; url_cebs=https://doi.org/10.22427/NTP-DATA-DTXSID2021151; source_file=acute_oral.xlsx
NTP_ICE_acute_oral GHS classification =5 Unitless Rat (Female) oral acute Rat Acute Oral Toxicity Studies submitted to EPA in support of pesticide registration applications (undated); record_id=acute_oral_13118; row=3890; data_type=In Vivo; mixture=Mixture; formulation_id=MIX520; formulation_name=Veriguard OD; chemical_name=2-Phenylphenol; preferred_name=2-Phenylphenol; percent_active_ingredient=15.0; dtxsid=DTXSID2021151; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2021151; url_cebs=https://doi.org/10.22427/NTP-DATA-DTXSID2021151; source_file=acute_oral.xlsx
NTP_ICE_acute_oral GHS classification =4 Unitless Rat (Female) oral acute Rat Acute Oral Toxicity Studies submitted to EPA in support of pesticide registration applications (undated); record_id=acute_oral_12720; row=3892; data_type=In Vivo; mixture=Mixture; formulation_id=MIX305; formulation_name=Mediclean Carpet Sanitizer; chemical_name=2-Phenylphenol; preferred_name=2-Phenylphenol; percent_active_ingredient=4.02; dtxsid=DTXSID2021151; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2021151; url_cebs=https://doi.org/10.22427/NTP-DATA-DTXSID2021151; source_file=acute_oral.xlsx
NTP_ICE_acute_oral GHS classification =5 Unitless Rat (Male) oral acute Rat Acute Oral Toxicity Studies submitted to EPA in support of pesticide registration applications (undated); record_id=acute_oral_12718; row=3894; data_type=In Vivo; mixture=Mixture; formulation_id=MIX305; formulation_name=Mediclean Carpet Sanitizer; chemical_name=2-Phenylphenol; preferred_name=2-Phenylphenol; percent_active_ingredient=4.02; dtxsid=DTXSID2021151; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2021151; url_cebs=https://doi.org/10.22427/NTP-DATA-DTXSID2021151; source_file=acute_oral.xlsx
NTP_ICE_acute_oral LD50 >5000 mg/kg bw Rat (Female) oral acute Rat Acute Oral Toxicity Studies submitted to EPA in support of pesticide registration applications (undated); record_id=acute_oral_12882; row=3858; data_type=In Vivo; mixture=Mixture; formulation_id=MIX378; formulation_name=Raid Ant & Roach Killer with Germ Kill CIK; chemical_name=2-Phenylphenol; preferred_name=2-Phenylphenol; percent_active_ingredient=0.1; dtxsid=DTXSID2021151; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2021151; url_cebs=https://doi.org/10.22427/NTP-DATA-DTXSID2021151; source_file=acute_oral.xlsx
NTP_ICE_acute_oral LD50 =591 mg/kg bw Rat (Female) oral acute Rat Acute Oral Toxicity Studies submitted to EPA in support of pesticide registration applications (undated); record_id=acute_oral_12825; row=3861; data_type=In Vivo; mixture=Mixture; formulation_id=MIX650; formulation_name=Orthophenylphenol/Sodium Orthophenylphenate; chemical_name=2-Phenylphenol; preferred_name=2-Phenylphenol; percent_active_ingredient=99.9; dtxsid=DTXSID2021151; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2021151; url_cebs=https://doi.org/10.22427/NTP-DATA-DTXSID2021151; source_file=acute_oral.xlsx
NTP_ICE_acute_oral LD50 =2733 mg/kg bw Rat (Female) oral acute Rat Acute Oral Toxicity Studies submitted to EPA in support of pesticide registration applications (undated); record_id=acute_oral_12822; row=3862; data_type=In Vivo; mixture=Mixture; formulation_id=MIX650; formulation_name=Orthophenylphenol/Sodium Orthophenylphenate; chemical_name=2-Phenylphenol; preferred_name=2-Phenylphenol; percent_active_ingredient=99.9; dtxsid=DTXSID2021151; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2021151; url_cebs=https://doi.org/10.22427/NTP-DATA-DTXSID2021151; source_file=acute_oral.xlsx
NTP_ICE_acute_oral LD50 >2000 mg/kg bw Rat (Female) oral acute Rat Acute Oral Toxicity Studies submitted to EPA in support of pesticide registration applications (undated); record_id=acute_oral_13118; row=3867; data_type=In Vivo; mixture=Mixture; formulation_id=MIX520; formulation_name=Veriguard OD; chemical_name=2-Phenylphenol; preferred_name=2-Phenylphenol; percent_active_ingredient=15.0; dtxsid=DTXSID2021151; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2021151; url_cebs=https://doi.org/10.22427/NTP-DATA-DTXSID2021151; source_file=acute_oral.xlsx
NTP_ICE_acute_oral LD50 >5000 mg/kg bw Rat (Male) oral acute Rat Acute Oral Toxicity Studies submitted to EPA in support of pesticide registration applications (undated); record_id=acute_oral_12718; row=3868; data_type=In Vivo; mixture=Mixture; formulation_id=MIX305; formulation_name=Mediclean Carpet Sanitizer; chemical_name=2-Phenylphenol; preferred_name=2-Phenylphenol; percent_active_ingredient=4.02; dtxsid=DTXSID2021151; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2021151; url_cebs=https://doi.org/10.22427/NTP-DATA-DTXSID2021151; source_file=acute_oral.xlsx
NTP_ICE_acute_oral LD50 =846 mg/kg bw Rat (Male) oral acute Rat Acute Oral Toxicity Studies submitted to EPA in support of pesticide registration applications (undated); record_id=acute_oral_12824; row=3869; data_type=In Vivo; mixture=Mixture; formulation_id=MIX650; formulation_name=Orthophenylphenol/Sodium Orthophenylphenate; chemical_name=2-Phenylphenol; preferred_name=2-Phenylphenol; percent_active_ingredient=99.9; dtxsid=DTXSID2021151; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2021151; url_cebs=https://doi.org/10.22427/NTP-DATA-DTXSID2021151; source_file=acute_oral.xlsx
NTP_ICE_acute_oral LD50 >5000 mg/kg bw Rat (Female) oral acute Rat Acute Oral Toxicity Studies submitted to EPA in support of pesticide registration applications (undated); record_id=acute_oral_12345; row=3870; data_type=In Vivo; mixture=Mixture; formulation_id=MIX95; formulation_name=Chemsico Aerosol LEG; chemical_name=2-Phenylphenol; preferred_name=2-Phenylphenol; percent_active_ingredient=0.1; dtxsid=DTXSID2021151; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2021151; url_cebs=https://doi.org/10.22427/NTP-DATA-DTXSID2021151; source_file=acute_oral.xlsx
NTP_ICE_adme_parameters 2 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
NTP_ICE_adme_parameters Clint 2.077 uL/min/10^6 cells Human - - Measured; httk, Human Hepatic Intrinsic Clearance sheet=Data; excel_row=820; Record_ID=adme_parameters_5; Data_Type=Measured; DTXSID=DTXSID2021151; Assay=httk, Human Hepatic Intrinsic Clearance; Endpoint=Clint; Response=2.077; Response_Unit=ul/min/10^6 cells; Species=Human; Reference=httk2.3.1, Wetmore 2012; URL=https://cran.r-project.org/web/packages/httk/index.html; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2021151; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID2021151
NTP_ICE_adme_parameters Fu 0.04105 fraction Human - - Measured; httk, Human Plasma Fraction Unbound sheet=Data; excel_row=819; Record_ID=adme_parameters_5; Data_Type=Measured; DTXSID=DTXSID2021151; Assay=httk, Human Plasma Fraction Unbound; Endpoint=Fu; Response=0.04105; Response_Unit=Unitless Fraction; Species=Human; Reference=httk2.3.1, Wetmore 2012; URL=https://cran.r-project.org/web/packages/httk/index.html; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2021151; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID2021151
NTP_ICE_cancer 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
NTP_ICE_cancer IARC group 3 unitless - - - WOE; IARC Carcinogenicity sheet=Data; excel_row=2579; Record_ID=cancer_4824; Data_Type=WOE; Formulation_Name=2-Phenylphenol; Mixture=Chemical; DTXSID=DTXSID2021151; Assay=IARC Carcinogenicity; Endpoint=IARC group; Response=3; Response_Unit=Unitless; URL=http://publications.iarc.fr/91; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2021151; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID2021151
NTP_ICE_endocrine 12 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
NTP_ICE_endocrine AC50 41.37403025207 uM - - - ERPathway2016; ER Pathway Model, Antagonist sheet=Integrated_approaches; excel_row=2740; RecordID=ERPathway2016_438; DatasetName=ERPathway2016; DTXSID=DTXSID2021151; Assay=ER Pathway Model, Antagonist; Endpoint=AC50; Response=41.37403025207; Response_Unit=uM; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2021151; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID2021151
NTP_ICE_endocrine AC50/EC50/IC50 6300 nM - - - In Vitro; AR Transactivation-Antagonist sheet=Data_invitro; excel_row=13239; Record_ID=endocrine_invitro_4099; Data_Type=In Vitro; Mixture=Chemical; DTXSID=DTXSID2021151; Assay=AR Transactivation-Antagonist; Endpoint=AC50/EC50/IC50; Reported_Response=6300; Reported_Response_Unit=nM; Response=6300; Response_Unit=nM; Reference=Kleinstreuer et al. 2016; 27933809; 10.1021/acs.chemrestox.6b00347|Krüger et al. 2008; 18294747; 10.1016/j.tox.2007.12.028; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2021151; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID2021151
NTP_ICE_endocrine AC50/EC50/IC50 12100 nM - - - In Vitro; AR Transactivation-Antagonist sheet=Data_invitro; excel_row=13241; Record_ID=endocrine_invitro_4100; Data_Type=In Vitro; Mixture=Chemical; DTXSID=DTXSID2021151; Assay=AR Transactivation-Antagonist; Endpoint=AC50/EC50/IC50; Reported_Response=12100; Reported_Response_Unit=nM; Response=12100; Response_Unit=nM; Reference=Kleinstreuer et al. 2016; 27933809; 10.1021/acs.chemrestox.6b00347|Indiveri et al. 2014; 24972338; 10.1016/j.reprotox.2014.06.004; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2021151; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID2021151
NTP_ICE_endocrine AC50/EC50/IC50 3430 nM - - - In Vitro; AR Transactivation-Antagonist sheet=Data_invitro; excel_row=13506; Record_ID=endocrine_invitro_4165; Data_Type=In Vitro; Mixture=Chemical; DTXSID=DTXSID2021151; Assay=AR Transactivation-Antagonist; Endpoint=AC50/EC50/IC50; Reported_Response=3430; Reported_Response_Unit=nM; Response=3430; Response_Unit=nM; Reference=Kleinstreuer et al. 2016; 27933809; 10.1021/acs.chemrestox.6b00347|Orton et al. 2011; 21310686; 10.1289/ehp.1002895; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2021151; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID2021151
NTP_ICE_endocrine ACC 38.34237180221 uM - - - ERPathway2016; ER Pathway Model, Antagonist sheet=Integrated_approaches; excel_row=2741; RecordID=ERPathway2016_438; DatasetName=ERPathway2016; DTXSID=DTXSID2021151; Assay=ER Pathway Model, Antagonist; Endpoint=ACC; Response=38.34237180221; Response_Unit=uM; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2021151; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID2021151
NTP_ICE_endocrine IC20 49000 nM - - - In Vitro; AR Transactivation-Antagonist sheet=Data_invitro; excel_row=13040; Record_ID=endocrine_invitro_4040; Data_Type=In Vitro; Mixture=Chemical; DTXSID=DTXSID2021151; Assay=AR Transactivation-Antagonist; Endpoint=IC20; Reported_Response=49000; Reported_Response_Unit=IC20 (nM); Response=49000; Response_Unit=nM; Reference=Kleinstreuer et al. 2016; 27933809; 10.1021/acs.chemrestox.6b00347; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2021151; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID2021151
NTP_ICE_endocrine LEL 10000 nM - - - In Vitro; AR Transactivation-Antagonist sheet=Data_invitro; excel_row=14971; Record_ID=endocrine_invitro_4099; Data_Type=In Vitro; Mixture=Chemical; DTXSID=DTXSID2021151; Assay=AR Transactivation-Antagonist; Endpoint=LEL; Reported_Response=10000; Reported_Response_Unit=nM; Response=10000; Response_Unit=nM; Reference=Kleinstreuer et al. 2016; 27933809; 10.1021/acs.chemrestox.6b00347|Krüger et al. 2008; 18294747; 10.1016/j.tox.2007.12.028; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2021151; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID2021151
NTP_ICE_endocrine Model Score 0 unitless - - - ARPathway2016; AR Pathway Model, Antagonist sheet=Integrated_approaches; excel_row=2736; RecordID=ARPathway2016_1703; DatasetName=ARPathway2016; DTXSID=DTXSID2021151; Assay=AR Pathway Model, Antagonist; Endpoint=Model Score; Response=0; Response_Unit=Unitless; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2021151; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID2021151
NTP_ICE_endocrine Model Score 0.00543 unitless - - - ERPathway2016; ER Pathway Model, Agonist sheet=Integrated_approaches; excel_row=2742; RecordID=ERPathway2016_438; DatasetName=ERPathway2016; DTXSID=DTXSID2021151; Assay=ER Pathway Model, Agonist; Endpoint=Model Score; Response=0.00543; Response_Unit=Unitless; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2021151; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID2021151
NTP_ICE_endocrine NOEL 1000 mg/kg bw/day Rat Oral Treatment_Duration=10 days; Age_at_First_Dose=PND 55; Age_Ovariectomized_or_Castrated=PND 45; Time_Elapsed_Between_Surgery_and_Treatment=10 days; Time_Elapsed_Between_Last_Dose_and_Necropsy=18 to 36 hours; Number_of_Doses_Tested=7 In Vivo; Hershberger-Agonist sheet=Data_invivo; excel_row=1202; Record_ID=endocrine_invivo_521; Data_Type=In Vivo; Mixture=Chemical; DTXSID=DTXSID2021151; Assay=Hershberger-Agonist; Endpoint=NOEL; Response=1000; Response_Unit=mg/kg/day; Species=Rat; Reported_Strain=Sprague-Dawley; Strain=Sprague-Dawley; Sex=Male (castrated); Route=Oral; Reference_Hormone=Testosterone propionate; Reference_Hormone_Dose=0.4; Reference_Hormone_Dose_Units=mg/kg/day; Reference_Hormone_Route=Subcutaneous; Additional_Information=Browne et al. 2018 unique record identifier 448; Reference=US EPA 2013; Not available; https://www.regulations.gov/document/EPA-HQ-OPP-2013-0524-0010|Browne et al. 2018; 30205136; 10.1016/j.reprotox.2018.08.016; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2021151; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID2021151
NTP_ICE_endocrine Relative potency 7 % - - - In Vitro; AR Transactivation-Antagonist sheet=Data_invitro; excel_row=15208; Record_ID=endocrine_invitro_4100; Data_Type=In Vitro; Mixture=Chemical; DTXSID=DTXSID2021151; Assay=AR Transactivation-Antagonist; Endpoint=Relative potency; Reported_Response=7; Reported_Response_Unit=%; Response=7; Response_Unit=%; Reference=Kleinstreuer et al. 2016; 27933809; 10.1021/acs.chemrestox.6b00347|Indiveri et al. 2014; 24972338; 10.1016/j.reprotox.2014.06.004; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2021151; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID2021151
NTP_ICE_endocrine Relative potency 59 % - - - In Vitro; AR Transactivation-Antagonist sheet=Data_invitro; excel_row=15209; Record_ID=endocrine_invitro_4040; Data_Type=In Vitro; Mixture=Chemical; DTXSID=DTXSID2021151; Assay=AR Transactivation-Antagonist; Endpoint=Relative potency; Reported_Response=59; Reported_Response_Unit=%; Response=59; Response_Unit=%; Reference=Kleinstreuer et al. 2016; 27933809; 10.1021/acs.chemrestox.6b00347; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2021151; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID2021151
NTP_ICE_eye_irritation 2 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
NTP_ICE_eye_irritation EPA Classification 3 unitless Rabbit Ocular - In Vivo; Draize Eye Irritation/Corrosion Test sheet=Data; excel_row=744; Record_ID=eye_irritation_401; Data_Type=In Vivo; Formulation_ID=EyeIrritation6pack_PID222; Formulation_Name=Chemsico Aerosol LEG; Percent_Active_Ingredient=0.1; Mixture=Mixture; DTXSID=DTXSID2021151; Assay=Draize Eye Irritation/Corrosion Test; Endpoint=EPA Classification; Response=3; Response_Unit=Unitless; Species=Rabbit; Reference=FIFRA data; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2021151; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID2021151
NTP_ICE_eye_irritation EPA Classification 1 unitless Rabbit Ocular - In Vivo; Draize Eye Irritation/Corrosion Test sheet=Data; excel_row=748; Record_ID=eye_irritation_1208; Data_Type=In Vivo; Formulation_ID=EyeIrritation6pack_PID1034; Formulation_Name=Veriguard OD; Percent_Active_Ingredient=15.0; Mixture=Mixture; DTXSID=DTXSID2021151; Assay=Draize Eye Irritation/Corrosion Test; Endpoint=EPA Classification; Response=1; Response_Unit=Unitless; Species=Rabbit; Reference=FIFRA data; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2021151; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID2021151
NTP_ICE_skin_irritation 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
NTP_ICE_skin_irritation EPA classification 2 unitless Rabbit Dermal - In Vivo; Draize Skin Irritation/Corrosion Test sheet=Data_invivo; excel_row=522; Record_ID=skin_irritation_invivo_677; Data_Type=In Vivo; Formulation_ID=MIX378; Formulation_Name=Raid Ant & Roach Killer with Germ Kill CIK; Percent_Active_Ingredient=0.1; Mixture=Mixture; DTXSID=DTXSID2021151; Assay=Draize Skin Irritation/Corrosion Test; Endpoint=EPA classification; Response=2; Response_Unit=Unitless; Species=Rabbit; Reference=FIFRA (undated); URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2021151; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID2021151
NTP_ICE_skin_irritation EPA classification 4 unitless Rabbit Dermal - In Vivo; Draize Skin Irritation/Corrosion Test sheet=Data_invivo; excel_row=523; Record_ID=skin_irritation_invivo_855; Data_Type=In Vivo; Formulation_ID=MIX520; Formulation_Name=Veriguard OD; Percent_Active_Ingredient=15; Mixture=Mixture; DTXSID=DTXSID2021151; Assay=Draize Skin Irritation/Corrosion Test; Endpoint=EPA classification; Response=4; Response_Unit=Unitless; Species=Rabbit; Reported_Strain=New Zealand White; Strain=New Zealand White; Reference=FIFRA (undated); URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2021151; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID2021151
NTP_ICE_skin_irritation EPA classification 3 unitless Rabbit Dermal - In Vivo; Draize Skin Irritation/Corrosion Test sheet=Data_invivo; excel_row=524; Record_ID=skin_irritation_invivo_1049; Data_Type=In Vivo; Formulation_ID=MIX95; Formulation_Name=Chemsico Aerosol LEG; Percent_Active_Ingredient=0.1; Mixture=Mixture; DTXSID=DTXSID2021151; Assay=Draize Skin Irritation/Corrosion Test; Endpoint=EPA classification; Response=3; Response_Unit=Unitless; Species=Rabbit; Reported_Strain=New Zealand White; Strain=New Zealand White; Sex=Male; Reference=FIFRA (undated); URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2021151; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID2021151
NTP_ICE_skin_irritation EPA classification 1 unitless Rabbit Dermal - In Vivo; Draize Skin Irritation/Corrosion Test sheet=Data_invivo; excel_row=526; Record_ID=skin_irritation_invivo_178; Data_Type=In Vivo; Formulation_ID=MIX650; Formulation_Name=Orthophenylphenol/Sodium Orthophenylphenate; Percent_Active_Ingredient=99.9; Mixture=Mixture; DTXSID=DTXSID2021151; Assay=Draize Skin Irritation/Corrosion Test; Endpoint=EPA classification; Response=1; Response_Unit=Unitless; Species=Rabbit; Reference=FIFRA (undated); URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2021151; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID2021151
SCCS_vision_codex 344 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
SCCS_vision_codex NOAEL >98 % rat oral 24 months NOAEL study {"citation":"Ref.: 106 SCCS comment Due to poor reporting the study cannot be used to derive a NOAEL","dose":"Decreased (p<0.01) body weights occurred in males (10 %) and females (6 %) at 20000 ppm.","effect":"SCCS-rejected applicant NOAEL: rol groups, only 22-32 % of the animals were alive at the end of 24 months. Decreased (p<0.01) body weights occurred in males (10 %) and females (6 %) at 20000 ppm. Another effect observed at the highest dose level was increased relative testis weight (46 %). Extensive renal damage characterised by marked tubular dilation with varying degrees of acute and chronic inflammation was found in male and female animals at the highest dose. Ref.: 106 SCCS comment Due to poor reporting the study cannot be used to derive a NOAEL. In a study from the open literature, Dowicide 1 (Lot MM01040, purity > 98 %) was administered for 91 weeks to male F344/DuCrj rats at dietary concentrations of 0, 0.625, 1.25 and 2.5 % corresponding to 0, 269, 531 and 1140 mg/kg bw/d. Survival was 100 %, 71 % (p < 0.05) and 65 % (p < 0.05) at 269, 531 and 1140 mg/kg bw/d, respectively. The following findings were observed in treated animals: increased (20 %) white blood cell count at the highest dose, hematuria at 531 and 1140 mg/kg bw/d, increased water intake","page":24,"pdf":"sccs_o_177.pdf","row_type":"noael_study","study_id":"sccs_o_177_noael_001"}
SCCS_vision_codex NOAEL =92 mg/kg/day mouse - - NOAEL study {"citation":"Ref.: 165, 166 SCCS conclusion Apparently the study was not performed according to an accepted guideline","dose":"ion to the increased incidence, the lesion severity (e.g., tubular epithelium degeneration) also appeared to increase with dose.","effect":"ion to the increased incidence, the lesion severity (e.g., tubular epithelium degeneration) also appeared to increase with dose. Reduced (p<0.05) absolute kidney weights occurred in each of the OPP-treated groups (7-24 %), but the dose-response seemed consistent with the general body weight reductions noted in these groups (12-43 %). Based on the induction of renal tubular epithelium degeneration, spleen atrophy, increased water intake, and increased relative liver weight, occurring at each concentration tested, a NOAEL cannot be derived. 92 mg/kg/day can be considered as LOAEL. Ref.: 165, 166 SCCS conclusion Apparently the study was not performed according to an accepted guideline. Only male animals were used in the study. The study can be used as supporting information about OPP target tissues in mice. Tumour incidences in the liver did not represent a dose response. Types of liver cancers were not reported. Guideline: OECD TG 453 Species/strain: mouse, B6C3F1 Group size: 50/sex/dose (main group) 10/sex/dose (satellite grou","page":25,"pdf":"sccs_o_177.pdf","row_type":"noael_study","study_id":"sccs_o_177_noael_002"}
SCCS_vision_codex NOAEL =250 mg/kg bw/d mouse oral 5d NOAEL study {"citation":"Ref.: 220, 221 In a GLP-compliant study four groups of beagle dogs (4 animals/sex/dose) received OPP (purity 99","dose":"ignificantly increased in livers of male mice, however, a statistically significant increase in hepatocellular adenoma was observed at the two highest doses (27/50 in controls, 33/50 at 250 mg/kg, 40/50 at 500 mg/kg, and 41/50 at 1000 mg/kg).","effect":"ignificantly increased in livers of male mice, however, a statistically significant increase in hepatocellular adenoma was observed at the two highest doses (27/50 in controls, 33/50 at 250 mg/kg, 40/50 at 500 mg/kg, and 41/50 at 1000 mg/kg). In female mice, also microscopic changes in livers were seen, however, no female mouse had a hepatoblastoma and there were no statistically significant increases in liver or other tumours in the female animals. As treatment-related effects were observed in all dose groups, no NOAEL can be derived from this study. The LOAEL is considered to be 250 mg/kg bw/d. SCCS comment In this study in mice, the heart was not identified as a target organ. CalEpa considered the incidence of hepatoblastoma at the mid dose as treatment-related due to its rare spontaneous occurrence in this strain. Ref.: 220, 221 In a GLP-compliant study four groups of beagle dogs (4 animals/sex/dose) received OPP (purity 99.77 %, identification #8800005-24) at gavage doses of 0, 30, 100, or 300 mg/kg bw/d, 5d / week, for","page":26,"pdf":"sccs_o_177.pdf","row_type":"noael_study","study_id":"sccs_o_177_noael_003"}
SCCS_vision_codex NOAEL >300 mg/kg/day mouse oral 5d NOAEL study {"citation":"Ref.: 220, 221 In a GLP-compliant study four groups of beagle dogs (4 animals/sex/dose) received OPP (purity 99","dose":"incidence of hepatoblastoma at the mid dose as treatment-related due to its rare spontaneous occurrence in this strain.","effect":"incidence of hepatoblastoma at the mid dose as treatment-related due to its rare spontaneous occurrence in this strain. Ref.: 220, 221 In a GLP-compliant study four groups of beagle dogs (4 animals/sex/dose) received OPP (purity 99.77 %, identification #8800005-24) at gavage doses of 0, 30, 100, or 300 mg/kg bw/d, 5d / week, for one year. There were no effects on body weight, feed consumption, ophthalmology, haematology, urinalysis, and pathology. The only clinical sign was vomiting (dose-dependent increase). A NOAEL > 300 mg/kg/day can be derived from this study. Ref.: 32 Dermal mouse Swiss CD-1 mice (50/sex) received repeated dermal applications of 55 mg OPP (99 % purity, lot MM09157), dissolved in 0.1 ml acetone solution for 102 weeks. Treatment did not affect survival and body weight. No skin neoplasms occurred in mice dosed with OPP, however non-neoplastic lesions (ulcer, active chronic inflammation, hyperkeratosis and acanthosis) were observed at the application site. Systemically, slightly increased incidences of di","page":26,"pdf":"sccs_o_177.pdf","row_type":"noael_study","study_id":"sccs_o_177_noael_004"}
SCCS_vision_codex NOAEL =39 mg/kg bw/d rat oral 2-year reproductive toxicity {"citation":"(Ref. 303)","dose":"303), a NOAEL of 39 mg/kg bw/d was obtained based on urinary bladder hyperplasia and urinary bladder transitional cell carcinoma.","effect":"OPP) • Species- and strain-specific differences (OPP-induced bladder tumours were not observed in female rats, mice, dogs) • dermal application to mice does not affect tumour incidence in skin • no skin tumour development induced by OPP metabolites • tumours occur at high doses when sulfate and glucuronide conjugation pathways are saturated The threshold for OPP-induced bladder tumours can be approached from different studies all yielding a quite consistent picture: In a 2-year bioassay in F344 rats (Ref. 303), a NOAEL of 39 mg/kg bw/d was obtained based on urinary bladder hyperplasia and urinary bladder transitional cell carcinoma. In a study investigating cytotoxicity and regenerative hyperplasia in male F344 rats fed different levels of OPP (Ref. 263), no effects were observed at a dose level of 0.08 % OPP in diet (corresponding to approximately 40 mg/kg bw/d). In a 2-generation reproductive toxicity study (see section 3.3.8.1) performed in Sprague-Dawley rats, a NOAEL of 35 mg/kg bw/d was identified based on morphological ch","page":32,"pdf":"sccs_o_177.pdf","row_type":"noael_study","study_id":"sccs_o_177_noael_005"}
SCCS_vision_codex NOAEL =35 mg/kg bw/d rat oral 2-year reproductive toxicity {"citation":"(Ref. 303)","dose":"303), a NOAEL of 39 mg/kg bw/d was obtained based on urinary bladder hyperplasia and urinary bladder transitional cell carcinoma.","effect":"picture: In a 2-year bioassay in F344 rats (Ref. 303), a NOAEL of 39 mg/kg bw/d was obtained based on urinary bladder hyperplasia and urinary bladder transitional cell carcinoma. In a study investigating cytotoxicity and regenerative hyperplasia in male F344 rats fed different levels of OPP (Ref. 263), no effects were observed at a dose level of 0.08 % OPP in diet (corresponding to approximately 40 mg/kg bw/d). In a 2-generation reproductive toxicity study (see section 3.3.8.1) performed in Sprague-Dawley rats, a NOAEL of 35 mg/kg bw/d was identified based on morphological changes in the urinary bladder (Ref. 36). SCCS conclusions on chronic toxicity and carcinogenicity The urinary bladder and kidneys of rats are the main target tissues after chronic administration of OPP and SOPP. OPP and SOPP resulted in urinary bladder tumours (papilloma and carcinoma, mainly transitional cell papilloma and carcinoma) in male F344 rats. At higher doses, also the renal pelvis and the renal papilla are target tissues for OPP- and SOPP toxicity","page":32,"pdf":"sccs_o_177.pdf","row_type":"noael_study","study_id":"sccs_o_177_noael_006"}
SCCS_vision_codex NOAEL =457 mg/kg rat - - reproductive toxicity {"citation":"Ref.: 36 SCCS comment SCCS notes that based on deviations from the Guideline protocol, Kwock and Silva (2013) stated that assessments on fertility in that study were inconclusive","dose":"The incidence of calculi in the kidney and/or urinary bladder was increased in male P and F1 rats at 125 and 457 mg/kg.","effect":"and F1 adults. The incidence of calculi in the kidney and/or urinary bladder was increased in male P and F1 rats at 125 and 457 mg/kg. Transitional cell hyperplasia/papillomatosis in the urinary bladder was diagnosed in 457 mg/kg P males and females and in 457 mg/kg F1 males. Morphometry measurements confirmed the microscopic findings at 457 mg/kg and indicated a compound-related effect also in 125 mg/kg P males and females. No embryotoxic or teratogenic effects were observed at doses up to 457 mg/kg. The overall NOAEL for the adults, based on morphological changes, was considered as 35 mg/kg. Ref.: 36 SCCS comment SCCS notes that based on deviations from the Guideline protocol, Kwock and Silva (2013) stated that assessments on fertility in that study were inconclusive. Guideline: OECD TG 416 Species/strain: rat, CD Sprague-Dawley Group size: 30/sex/dose Test substance: OPP, technical grade Batch: S-01-93 (mixture of OPP from Dow and Bayer) Purity: 99.5 – 100 % Vehicle: / Dose levels: 0, 20, 100, 500 mg/kg bw/d Dose volume: /","page":33,"pdf":"sccs_o_177.pdf","row_type":"noael_study","study_id":"sccs_o_177_noael_007"}
SCCS_vision_codex NOAEL =500 mg/kg bw/d - - chronic reproductive toxicity {"citation":"Ref.:37, 38 SCCS comment Some important reprotoxic parameters (e","dose":", and an increased severity of background lesions in the kidneys, transitional cell hyperplasia (simple and/or nodular/papillary), calculi, and chronic inflammation in the urinary bladder as well as dilatation and hyperplasia of the ureter in P and F1 males at 500 mg/kg.","effect":", and an increased severity of background lesions in the kidneys, transitional cell hyperplasia (simple and/or nodular/papillary), calculi, and chronic inflammation in the urinary bladder as well as dilatation and hyperplasia of the ureter in P and F1 males at 500 mg/kg. There were no effects on adult reproductive parameters. Pup weights were lower at 500 mg/kg bw/d. No effects were seen on litter size, gender distribution, number of stillborn, viability, clinical signs or gross pathology of pups. The reproductive NOAEL in this study was considered to be 500 mg/kg bw/d. The parental and neonatal NOAEL was considered to be 100 mg/kg based on decreased body weights, decreased pup weights and morphologic lesions in kidneys, urinary bladder and urether at 500 mg/kg bw/d. Ref.:37, 38 SCCS comment Some important reprotoxic parameters (e.g. sperm parameters, yellow bodies, weight of some reproductive organs) were not assessed in this study. 3.3.8.2 Other data on fertility and reproduction toxicity / 3.3.8.3 Developmental Toxicity R","page":34,"pdf":"sccs_o_177.pdf","row_type":"noael_study","study_id":"sccs_o_177_noael_008"}
SCCS_vision_codex NOAEL =100 mg/kg rabbit - chronic reproductive toxicity {"citation":"Ref.:37, 38 SCCS comment Some important reprotoxic parameters (e","dose":"hyperplasia (simple and/or nodular/papillary), calculi, and chronic inflammation in the urinary bladder as well as dilatation and hyperplasia of the ureter in P and F1 males at 500 mg/kg.","effect":"hyperplasia (simple and/or nodular/papillary), calculi, and chronic inflammation in the urinary bladder as well as dilatation and hyperplasia of the ureter in P and F1 males at 500 mg/kg. There were no effects on adult reproductive parameters. Pup weights were lower at 500 mg/kg bw/d. No effects were seen on litter size, gender distribution, number of stillborn, viability, clinical signs or gross pathology of pups. The reproductive NOAEL in this study was considered to be 500 mg/kg bw/d. The parental and neonatal NOAEL was considered to be 100 mg/kg based on decreased body weights, decreased pup weights and morphologic lesions in kidneys, urinary bladder and urether at 500 mg/kg bw/d. Ref.:37, 38 SCCS comment Some important reprotoxic parameters (e.g. sperm parameters, yellow bodies, weight of some reproductive organs) were not assessed in this study. 3.3.8.2 Other data on fertility and reproduction toxicity / 3.3.8.3 Developmental Toxicity Rabbits Guideline: OECD TG 414 Species/strain: Female rabbit, White New Zealand Gro","page":34,"pdf":"sccs_o_177.pdf","row_type":"noael_study","study_id":"sccs_o_177_noael_009"}
SCCS_vision_codex NOAEL =100 mg/kg/d rat - developmental developmental toxicity {"citation":"Ref.: 319","dose":"11.1 – 66.7 %) were observed at 100 (77 %) and 250 (72 %) mg/kg/d.","effect":"nomalies or malformations (data not shown). The only developmental effect of OPP in rabbits was increased incidence of litters with resorptions. Kwock and Silva (2013) carefully re-examined all available data considering probable statistical pitfalls. They came to the conclusion that statistically significant increases in resorptions clearly exceeding the actual control group (33.3 %) and the mean of historical controls (36.2 %, range: 11.1 – 66.7 %) were observed at 100 (77 %) and 250 (72 %) mg/kg/d. The maternal NOAEL was set at 100 mg/kg/d and the developmental NOAEL was set at 25 mg/kg/d. A NOAEL of 25 mg/kg bw/d will be taken for MOS calculation. Ref.: 319; Kwock and Silva (2013) Rats In a study from the open literature, OPP (commercial grade biocide, 99.69 % purity) at dose levels of 0, 100, 300 and 700 mg/kg bw/d was investigated in pregnant Sprague- Dawley rats (24 – 26 dams/dose; 36 control animals) for embryotoxic and teratogenic effects. Dose levels were based on the results of a range-finding study. One dam died at","page":35,"pdf":"sccs_o_177.pdf","row_type":"noael_study","study_id":"sccs_o_177_noael_010"}
SCCS_vision_codex NOAEL =25 mg/kg/d rat - developmental developmental toxicity {"citation":"Ref.: 319","dose":"11.1 – 66.7 %) were observed at 100 (77 %) and 250 (72 %) mg/kg/d.","effect":"y developmental effect of OPP in rabbits was increased incidence of litters with resorptions. Kwock and Silva (2013) carefully re-examined all available data considering probable statistical pitfalls. They came to the conclusion that statistically significant increases in resorptions clearly exceeding the actual control group (33.3 %) and the mean of historical controls (36.2 %, range: 11.1 – 66.7 %) were observed at 100 (77 %) and 250 (72 %) mg/kg/d. The maternal NOAEL was set at 100 mg/kg/d and the developmental NOAEL was set at 25 mg/kg/d. A NOAEL of 25 mg/kg bw/d will be taken for MOS calculation. Ref.: 319; Kwock and Silva (2013) Rats In a study from the open literature, OPP (commercial grade biocide, 99.69 % purity) at dose levels of 0, 100, 300 and 700 mg/kg bw/d was investigated in pregnant Sprague- Dawley rats (24 – 26 dams/dose; 36 control animals) for embryotoxic and teratogenic effects. Dose levels were based on the results of a range-finding study. One dam died at 700 mg/kg bw/day due to dosing error but there were","page":35,"pdf":"sccs_o_177.pdf","row_type":"noael_study","study_id":"sccs_o_177_noael_011"}
SCCS_vision_codex NOAEL =100 mg/kg bw/d rat oral - NOAEL study {"citation":"Ref.: 129","dose":"hree skeletal anomalies were statistically significantly increased (~13-15 %) at 700 mg/kg/d (delayed ossification of sternebrae, pinpoint holes in the occipital or interparietal plates in the skull, and skull bone island).","effect":"hree skeletal anomalies were statistically significantly increased (~13-15 %) at 700 mg/kg/d (delayed ossification of sternebrae, pinpoint holes in the occipital or interparietal plates in the skull, and skull bone island). Kwock and Silva (2013) discuss, that pre-implantation losses, which were observed at the highest dose tested, might be instances of early resorptions due to the methodologies applied for evaluation of this effect. Based on the results of this study, 100 mg/kg bw/d should be regarded as maternal NOAEL (due to decreased body weight and food consumption at 300 mg/kg bw/d) and 300 mg/kg bw/d should be regarded as the foetal NOAEL. Ref.: 129; Kwock and Silva (2013) In a further study from the open literature (no information on guideline adherence or GLP), pregnant Wistar rats (18-20 dams/dose; 11 dams at the highest dose tested) were treated with OPP (99.7 % purity) by gavage at 0 (aqueous gum arabic), 150, 300, 600, or 1200 mg/kg bw/d on gestation days (GD) 6 through 15. The animals were sacrificed on GD 20. At","page":36,"pdf":"sccs_o_177.pdf","row_type":"noael_study","study_id":"sccs_o_177_noael_013"}
SCCS_vision_codex NOAEL =300 mg/kg bw/d rat oral 9 days NOAEL study {"citation":"Ref.: 129","dose":"Kwock and Silva (2013) discuss, that pre-implantation losses, which were observed at the highest dose tested, might be instances of early resorptions due to the methodologies applied for evaluation of this effect.","effect":", pinpoint holes in the occipital or interparietal plates in the skull, and skull bone island). Kwock and Silva (2013) discuss, that pre-implantation losses, which were observed at the highest dose tested, might be instances of early resorptions due to the methodologies applied for evaluation of this effect. Based on the results of this study, 100 mg/kg bw/d should be regarded as maternal NOAEL (due to decreased body weight and food consumption at 300 mg/kg bw/d) and 300 mg/kg bw/d should be regarded as the foetal NOAEL. Ref.: 129; Kwock and Silva (2013) In a further study from the open literature (no information on guideline adherence or GLP), pregnant Wistar rats (18-20 dams/dose; 11 dams at the highest dose tested) were treated with OPP (99.7 % purity) by gavage at 0 (aqueous gum arabic), 150, 300, 600, or 1200 mg/kg bw/d on gestation days (GD) 6 through 15. The animals were sacrificed on GD 20. At the highest dose tested, 10/11 dams died after 3-9 days of treatment. At 600 mg/kg bw/d, 2 of the 20 dams died. At ≥ 300 mg/kg b","page":36,"pdf":"sccs_o_177.pdf","row_type":"noael_study","study_id":"sccs_o_177_noael_014"}
SCCS_vision_codex NOAEL =150 mg/kg mouse - developmental developmental toxicity {"citation":"Ref.:133","dose":"At ≥ 300 mg/kg bw/d, pregnant animals fell into ataxia for several hours and there was a dose-related increase.","effect":"g/kg bw/d, 2 of the 20 dams died. At ≥ 300 mg/kg bw/d, pregnant animals fell into ataxia for several hours and there was a dose-related increase. At doses ≥ 300 mg/kg bw/d, dams had decreased body weight gains from GD 9. Effects to foetuses from OPP exposure in utero at the 600 mg/kg bw/d group appeared as an increased (p<0.01) incidence of resorptions and reduced foetal body weights (both sexes). From the results of the study it can be concluded that foetal effects occurred at maternally toxic doses. The maternal NOAEL can be set at 150 mg/kg be/d based on decreased body weight gain and occurrence of ataxia from 300 mg/kg bw/d. The foetal (developmental) NOAEL can be set at 600 mg/kg bw/d based on reduced foetal body weight and an increased incidence of resorptions. Ref.:133; Kwock and Silva (2013) Mice The developmental toxicity of OPP (from Tokyo Kasei Ltd., Lot FB 103) and SOPP (from Dow, Lot MM0144) has been investigated in mice. No information on guideline adherence or GLP is available. In the study with OPP, four groups","page":36,"pdf":"sccs_o_177.pdf","row_type":"noael_study","study_id":"sccs_o_177_noael_015"}
SCCS_vision_codex NOAEL =600 mg/kg bw/d mouse oral developmental developmental toxicity {"citation":"Ref.:133","dose":"At doses ≥ 300 mg/kg bw/d, dams had decreased body weight gains from GD 9.","effect":". At doses ≥ 300 mg/kg bw/d, dams had decreased body weight gains from GD 9. Effects to foetuses from OPP exposure in utero at the 600 mg/kg bw/d group appeared as an increased (p<0.01) incidence of resorptions and reduced foetal body weights (both sexes). From the results of the study it can be concluded that foetal effects occurred at maternally toxic doses. The maternal NOAEL can be set at 150 mg/kg be/d based on decreased body weight gain and occurrence of ataxia from 300 mg/kg bw/d. The foetal (developmental) NOAEL can be set at 600 mg/kg bw/d based on reduced foetal body weight and an increased incidence of resorptions. Ref.:133; Kwock and Silva (2013) Mice The developmental toxicity of OPP (from Tokyo Kasei Ltd., Lot FB 103) and SOPP (from Dow, Lot MM0144) has been investigated in mice. No information on guideline adherence or GLP is available. In the study with OPP, four groups of Jcl:ICR mice considered pregnant (21 animals/dose) received gavage dosages of 0, 1450, 1740, and 2100 mg/kg bw/d OPP in olive oil from GD 7 t","page":36,"pdf":"sccs_o_177.pdf","row_type":"noael_study","study_id":"sccs_o_177_noael_016"}
SCCS_vision_codex NOAEL =100 mg/kg bw rat - developmental reproductive toxicity {"dose":"No adverse effects of OPP on foetuses of rabbits were observed, however, there were increased incidences of resorptions independent from maternal toxicity, leading to a developmental NOAEL of 25 mg/kg bw/d.","effect":"n investigated in rabbits, rats and mice and there is a report on developmental toxicity of SOPP in mice. No adverse effects of OPP on foetuses of rabbits were observed, however, there were increased incidences of resorptions independent from maternal toxicity, leading to a developmental NOAEL of 25 mg/kg bw/d. An increased incidence of resorption was also reported from developmental toxicity studies performed with OPP in rats. The lowest maternal NOAEL of OPP identified in rats was 100 mg/kg bw whereas the lowest NOAEL for development identified in rats was 300 mg/kg bw/d. In mice treated with comparably high doses of OPP, maternal and developmental effects were observed at all concentrations tested and an LOAEL of 1450 mg/kg bw/d was identified. In mice treated with SOPP, developmental effects (reduced foetal weight and increased incidence of cleft palate) could be observed at the lowest dose tested (100 mg/kg bw/d). As a summary, whereas OPP does not adversely affect fertility or reproductive","page":37,"pdf":"sccs_o_177.pdf","row_type":"noael_study","study_id":"sccs_o_177_noael_019"}
SCCS_vision_codex NOAEL =25 mg/kg bw/d - - developmental developmental toxicity {"citation":"(ref. California Environmental Protection Agency, April 2007. Ortho-Phenylphenol (OPP)","dose":"The lowest developmental NOAEL identified was 25 mg/kg bw/d, which will be taken for MOS calculation.","effect":"SCCS/1555/15 Revision of the Opinion on o-Phenylphenol, Sodium o-phenylphenate and Potassium o-phenylphenate ____________________________________________________________________________________________________________________ 38 organs, increased incidence of resorptions can be considered as a developmental effect of OPP and SOPP. The lowest developmental NOAEL identified was 25 mg/kg bw/d, which will be taken for MOS calculation. 3.3.9 Toxicokinetics 3.3.9.1 Toxicokinetics in laboratory animals The toxicokinetics of OPP has been investigated in vitro and in vivo in different species. The principal metabolic pathways are given in figure 1. Figure 1: Overview on the metabolic pathways of OPP in different mammalian species (ref. California Environmental Protection Agency, April 2007. Ortho-Phenylphenol (OPP) and Sodium Ortho-Phenylphenate (SOPP), Risk Characteriza","page":38,"pdf":"sccs_o_177.pdf","row_type":"noael_study","study_id":"sccs_o_177_noael_020"}
SCCS_vision_codex NOAEL =100 % rabbit oral developmental developmental toxicity {"dose":"Absorption through the skin DAp (%) = 45 % Amount of cosmetic product applied daily A (g/d) = 17.4 g/d Concentration of ingredient in finished product C (%) = 0.2 % Typical body weight of human = 60 kg Systemic exposure dose (SED) = A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60 = 0.261 mg/kg bw/d No adverse observed effect level NOAEL = 25 m...","effect":"MoS calculation according to the SCCS's Notes of Guidance 8th revision. Absorption through the skin DAp (%) = 45 % Amount of cosmetic product applied daily A (g/d) = 17.4 g/d Concentration of ingredient in finished product C (%) = 0.2 % Typical body weight of human = 60 kg Systemic exposure dose (SED) = A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60 = 0.261 mg/kg bw/d No adverse observed effect level NOAEL = 25 mg/kg bw/d (oral developmental toxicity study, rabbit) No adjustment, 100 % oral absorption MOS NOAEL/SED = 96 2. Rinse-off products An aggregate value of 0.54 g/d (8.3 mg/kg bw/d) for the amount of cosmetics applied daily is taken for MoS calculation, according to the SCCS's Notes of Guidance 8th revision. Absorption through the skin DAp (%) = 45 % Amount of cosmetic product applied daily A (g/d) = 0.54 g/d Concentration of ingredient in finished product C (%) = 0.2 % Typical body weight of human = 60 kg Systemic exposure dose (SED) = A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60 = 0.0081 mg/kg bw/d No","page":47,"pdf":"sccs_o_177.pdf","row_type":"noael_study","study_id":"sccs_o_177_noael_025"}
SCCS_vision_codex NOAEL =4 % rat oral - NOAEL study {"dose":"352, 694, 1338, and 2431 mg/kg bw/day for females papillomas plus 5 transitional cell carcinomas at 2% and 1 transitional cell carcinoma at 4%, as opposed to only 2 papillomas at 4% in females.","effect":"352, 694, 1338, and 2431 mg/kg bw/day for females papillomas plus 5 transitional cell carcinomas at 2% and 1 transitional cell carcinoma at 4%, as opposed to only 2 papillomas at 4% in females. No bladder calculi were observed. Moderate pyelonephritis was recorded in 6/10 males and slight in 1/10 females at 4%. No tumours at sites other than the urinary system were found. Liver: increases in liver weight; changes in liver enzymes. Kidneys: pyelonephritis in high dose males and females; increase in kidney weights. NOAEL. In 4 % males: pyelonephritis as predominating effect (60%; p≤0.01); in 2% males: neoplastic lesions in bladder as predominating effect (transitional cell papilloma, 44% (p≤0.05); transitional cell carcinoma 56% (p≤0.01). Purity SOPP > 95% Unclear (Text body in Japanese) male F344 rats (n=20/group) Dietary administration of 0, 0.625, 1.25, or 2.5% Body weight gain dose-dependently decreased at 1.25 and 2.5%. No changes were noted in biochemical investigations of plasma samples. Red blood cell count and the amoun","page":80,"pdf":"sccs_o_177.pdf","row_type":"noael_study","study_id":"sccs_o_177_noael_032"}
SCCS_vision_codex NOAEL =2.5 % rat oral - NOAEL study {"dose":"Unclear (Text body in Japanese) | male F344 rats (n=20/group) Dietary administration of 0, 0.625, 1.25, or 2.5% | Body weight gain dose-dependently decreased at 1.25 and 2.5%.","effect":"Unlabeled table on page 80: Unclear (Text body in Japanese) | male F344 rats (n=20/group) Dietary administration of 0, 0.625, 1.25, or 2.5% | Body weight gain dose-dependently decreased at 1.25 and 2.5%. No changes were noted in biochemical investigations of plasma samples. Red blood cell count and the amount of haemoglobin were decreased at 2.5%. The relative weight of the urinary bladder was dose-dependently increased (nearly by about 50% at the highest concentration). The | Decrease of urinary pH observed; acidification could be due to nephritis; supporting study. Publication in Japanese, only tables and numbers | 190","page":80,"pdf":"sccs_o_177.pdf","row_type":"noael_study","study_id":"sccs_o_177_noael_034"}
SCCS_vision_codex NOAEL =25 mg/kg bw/day rat - developmental developmental toxicity {"dose":"As a result, the LOAEL was established at 1450 mg/kg bw/day.","effect":"l effects were observed at all tested doses. As a result, the LOAEL was established at 1450 mg/kg bw/day. Similarly, an increased incidence of resorptions was reported in rat developmental toxicity studies with OPP. The lowest NOAELs identified for maternal and developmental effects were 100 and 300 mg/kg bw/day, respectively. In rabbits, no adverse effects on foetuses were observed. However, increased incidences of resorptions were noted, and these appeared to be independent of maternal toxicity. As a result, the NOAEL for developmental toxicity was established at 25 mg/kg bw/day. In the mouse study with SOPP, developmental effects, such as reduced foetal weight and an increased incidence of cleft palate, were observed even at the lowest dose tested (100 mg/kg bw/day). The only developmental toxicity study with SOPP, is not considered to be useful in safety assessment due to design and reporting limitations. However, it did suggest SOPP's potential interference with rodent development. In summary, while OPP did not adversely aff","page":31,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_001"}
SCCS_vision_codex NOAEL =25 mg/kg/d rabbit oral developmental reproductive toxicity {"dose":"In summary, while OPP did not adversely affect fertility or reproductive organs, the increased incidence of resorptions can be considered a developmental effect of both OPP and SOPP with a critical NOAEL of 25 mg/kg bw/day.","effect":"potential interference with rodent development. In summary, while OPP did not adversely affect fertility or reproductive organs, the increased incidence of resorptions can be considered a developmental effect of both OPP and SOPP with a critical NOAEL of 25 mg/kg bw/day. SCCS comment on developmental toxicity In SCCS/1555/15, the SCCS derived a NOAEL of 25 mg/kg/d based on a re-analysis by Kwock and Silva (2013) of data from a teratology study performed in New Zealand White Rabbits (Zablotny et al., 1991b). This NOAEL is lower than other PoDs obtained from other repeat- dose/long-term toxicity studies performed with OPP and SOPP. Therefore, this conservative value of 25 mg/kg bw/d is taken for MoS calculation for both, OPP and SOPP. 3.4.6 Mutagenicity / genotoxicity According to the Applicant In in vitro assays with OPP and SOPP, minimal evidence of mutagenicity was observed, while clastogenicity occurred primarily in the presence of overt cytotoxicity. In vivo, micronucleus formation and/or DNA damage after oral or dermal ex","page":31,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_004"}
SCCS_vision_codex NOAEL =250 mg/kg bw/day rat oral chronic carcinogenicity {"dose":"The NOAEL was established at 250 mg/kg bw/day.","effect":"nicity studies conducted with OPP and SOPP via the oral route identified the urinary bladder and kidneys as the main target tissues in mice and rats. A combined chronic toxicity/carcinogenicity study in B6C3F1 mice revealed that OPP induced tumours in liver and changes in kidney tubule morphology. The liver tumours observed in male mice were attributed to the high spontaneous occurrence of liver tumours in this specific mouse strain. The kidney changes included hypertrophy and increased relative kidney weight. The NOAEL was established at 250 mg/kg bw/day. In chronic toxicity/carcinogenicity in rats, kidney effects such as hyperplasia, cysts, infarct, acute inflammation, and papilla mineralisation of the kidney were observed. Further, neoplastic changes related to urinary bladder such as increased incidences of transitional cell carcinomas, papilloma, and increased incidence of calculi, congestion, haemorrhage mineralization and necrosis in the urinary bladder were observed. Based on the above effects, the NOAEL of 39 mg/kg bw/da","page":35,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_005"}
SCCS_vision_codex NOAEL =39 mg/kg bw/day rat - chronic carcinogenicity {"dose":"The NOAEL was established at 250 mg/kg bw/day.","effect":"idney weight. The NOAEL was established at 250 mg/kg bw/day. In chronic toxicity/carcinogenicity in rats, kidney effects such as hyperplasia, cysts, infarct, acute inflammation, and papilla mineralisation of the kidney were observed. Further, neoplastic changes related to urinary bladder such as increased incidences of transitional cell carcinomas, papilloma, and increased incidence of calculi, congestion, haemorrhage mineralization and necrosis in the urinary bladder were observed. Based on the above effects, the NOAEL of 39 mg/kg bw/day was established. In another combined chronic and carcinogenicity study, rats exhibited an increased incidence of hepatocellular adenoma with extensive renal damage characterised by tubular dilation and varying degrees of acute and chronic inflammation at 1000 mg/kg bw/day. Furthermore, a 91-week study in male F344 rats associated OPP treatment with the development of urinary bladder tumours, such as papilloma and carcinoma, primarily transitional cell papilloma and carcinoma at and above 531 mg/","page":35,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_006"}
SCCS_vision_codex NOAEL =95 mg/kg bw/day rat dermal 2- year carcinogenicity {"dose":"The LOAEL for the first study was established at 224 mg/kg bw/day based on the increased incidence of focal atrophy of pancreas in females and the NOAEL was established at 95 mg/kg bw/day.","effect":"a 2- year carcinogenicity study (conducted in 2 parts) in F344 rats, SOPP induced kidney tumours and increased incidences of interstitial nephritis of the kidney and increased incidences of focal atrophy of pancreatic acinar cells in females. Additionally, there was an increased incidence of urinary bladder tumours, including transitional cell papillomas and carcinomas. The LOAEL for the first study was established at 224 mg/kg bw/day based on the increased incidence of focal atrophy of pancreas in females and the NOAEL was established at 95 mg/kg bw/day. In a 112-week study in F344 male rats, transitional cell carcinoma was observed in rats at and above 1500 mg/kg bw/day. In a 102-week dermal carcinogenicity study in Swiss CD-1 mice, OPP did not induce skin neoplasms. In a 52-week, two-stage mouse skin carcinogenesis study in female CD-1 mice, SOPP induced epidermal proliferation and can act as a promoter but not as an initiator or a complete carcinogen. Overall, OPP and SOPP did not induce tumours when applied dermally. However","page":35,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_008"}
SCCS_vision_codex NOAEL =49 mg/kg bw/day rat oral 13 weeks carcinogenicity {"dose":"ssation of 13 weeks of exposure to OPP) • Sex and species- and strain-specific differences (OPP-induced bladder tumours were not observed in female rats, mice, dogs) • dermal application to mice does not affect tumour incidence in skin • no skin tumour development induced by OPP metabolites • tumours occur at high doses when sulfate and glucuron...","effect":"ssation of 13 weeks of exposure to OPP) • Sex and species- and strain-specific differences (OPP-induced bladder tumours were not observed in female rats, mice, dogs) • dermal application to mice does not affect tumour incidence in skin • no skin tumour development induced by OPP metabolites • tumours occur at high doses when sulfate and glucuronide conjugation pathways are saturated The SCCS has noted the NOAELs proposed by the Applicant for OPP and SOPP for systemic toxicity and carcinogenicity (for OPP: lowest NOAEL established at 39 and 49 mg/kg bw/day in males and females, respectively; for SOPP, an oral LOAEL of 224 mg/kg bw/day from a 104-week carcinogenicity study in rats has been considered as most appropriate and conservative value for PoD derivation. The Applicant applied a composite uncertainty factor of 10 to account for the extrapolation from LOAEL to NOAEL and study data quality resulting in a corrected PoD of 22.4 mg/kg bw/day. The SCCS, however, stated in SCCS/1555/15 that the 104-week carcinogenicity study in r","page":37,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_009"}
SCCS_vision_codex NOAEL =22.4 mg/kg bw/day rat oral 104-week developmental toxicity {"dose":"ion pathways are saturated The SCCS has noted the NOAELs proposed by the Applicant for OPP and SOPP for systemic toxicity and carcinogenicity (for OPP: lowest NOAEL established at 39 and 49 mg/kg bw/day in males and females, respectively; for SOPP, an oral LOAEL of 224 mg/kg bw/day from a 104-week carcinogenicity study in rats has been considere...","effect":"ion pathways are saturated The SCCS has noted the NOAELs proposed by the Applicant for OPP and SOPP for systemic toxicity and carcinogenicity (for OPP: lowest NOAEL established at 39 and 49 mg/kg bw/day in males and females, respectively; for SOPP, an oral LOAEL of 224 mg/kg bw/day from a 104-week carcinogenicity study in rats has been considered as most appropriate and conservative value for PoD derivation. The Applicant applied a composite uncertainty factor of 10 to account for the extrapolation from LOAEL to NOAEL and study data quality resulting in a corrected PoD of 22.4 mg/kg bw/day. The SCCS, however, stated in SCCS/1555/15 that the 104-week carcinogenicity study in rats performed with SOPP was not performed according to currently accepted standards but that it can be used as supporting information. Therefore, the SCCS will use the NOAEL of 25 mg/kg bw/d obtained from a developmental toxicity study for MoS calculation of both OPP and SOPP. This value is supported by the Applicant’s corrected PoD for SOPP of 22.4 mg/kg","page":37,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_010"}
SCCS_vision_codex NOAEL =25 mg/kg bw/d rabbit oral developmental developmental toxicity {"dose":"ts) An aggregate value of 17.4 g/d (269 mg/kg bw/d) for the amount of cosmetics applied daily is taken for MoS calculation according to the SCCS's Notes of Guidance 12th revision.","effect":"ts) An aggregate value of 17.4 g/d (269 mg/kg bw/d) for the amount of cosmetics applied daily is taken for MoS calculation according to the SCCS's Notes of Guidance 12th revision. Absorption through the skin DAp (%) = 45 % Amount of cosmetic product applied daily A (g/d) = 14.54 g/d Concentration of ingredient in finished product C (%) = 0.15 % Typical body weight of human = 60 kg Systemic exposure dose (SED) = A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60 = 0.163 mg/kg bw/d No adverse observed effect level NOAEL = 25 mg/kg bw/d (oral developmental toxicity study, rabbit) No adjustment, 100 % oral absorption Margin of Safety adjusted NOAEL/SED = 153 OPP in rinse-off products An aggregate value of 0.54 g/d (8.3 mg/kg bw/d) for the amount of cosmetics applied daily is taken for MoS calculation, according to the SCCS's Notes of Guidance 12th revision. Absorption through the skin DAp (%) = 45 % Amount of cosmetic product applied daily A (g/d) = 0.54 g/d Concentration of ingredient in finished product C (%) = 0.2 % Typica","page":41,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_012"}
SCCS_vision_codex NOAEL =100 % rabbit oral developmental developmental toxicity {"dose":"Absorption through the skin DAp (%) = 45 % Amount of cosmetic product applied daily A (g/d) = 14.54 g/d Concentration of ingredient in finished product C (%) = 0.15 % Typical body weight of human = 60 kg Systemic exposure dose (SED) = A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60 = 0.163 mg/kg bw/d No adverse observed effect level NOAEL = 25...","effect":"ing to the SCCS's Notes of Guidance 12th revision. Absorption through the skin DAp (%) = 45 % Amount of cosmetic product applied daily A (g/d) = 14.54 g/d Concentration of ingredient in finished product C (%) = 0.15 % Typical body weight of human = 60 kg Systemic exposure dose (SED) = A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60 = 0.163 mg/kg bw/d No adverse observed effect level NOAEL = 25 mg/kg bw/d (oral developmental toxicity study, rabbit) No adjustment, 100 % oral absorption Margin of Safety adjusted NOAEL/SED = 153 OPP in rinse-off products An aggregate value of 0.54 g/d (8.3 mg/kg bw/d) for the amount of cosmetics applied daily is taken for MoS calculation, according to the SCCS's Notes of Guidance 12th revision. Absorption through the skin DAp (%) = 45 % Amount of cosmetic product applied daily A (g/d) = 0.54 g/d Concentration of ingredient in finished product C (%) = 0.2 % Typical body weight of human = 60 kg Systemic exposure dose (SED) = A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60 = 0.0081 mg/kg bw","page":41,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_013"}
SCCS_vision_codex NOAEL =10000 mg/kg bw/day rat oral Sub-acute repeated dose toxicity {"dose":"Repeated dose toxicity Oral repeated dose toxicity studies Study type, Species Doses Key findings NOAEL or LOAEL Reference#/ KL rating OPP Sub-acute studies 1-month dietary study in rats (strain not specified) (5 females/ group); no guideline 0, 2000, 3000, 4000, 5000 and 10000 mg/kg bw/day At 2000 mg/kg bw/day and slight growth retardation was...","effect":"SCCS/1669/24 Final version Opinion on the safety of Biphenyl-2-ol and Sodium 2-biphenylolate (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 65 9.4 ANNEX 4. Repeated dose toxicity Oral repeated dose toxicity studies Study type, Species Doses Key findings NOAEL or LOAEL Reference#/ KL rating OPP Sub-acute studies 1-month dietary study in rats (strain not specified) (5 females/ group); no guideline 0, 2000, 3000, 4000, 5000 and 10000 mg/kg bw/day At 2000 mg/kg bw/day and slight growth retardation was observed, all of the other dose groups lost weight rapidly. LOAEL: 2000 mg/kg bw/day Hodge et al., 1952 in (ECHA RAC, 2022)/KL2 32-day gavage study in male rats (15 males/ group); no guideline 0, 2, 20 and 200 mg/kg bw/day No treatment related adverse effects on any of parame","page":65,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_023"}
SCCS_vision_codex NOAEL =200 mg/kg bw/day rat oral Sub-acute repeated dose toxicity {"dose":"rating OPP Sub-acute studies 1-month dietary study in rats (strain not specified) (5 females/ group); no guideline 0, 2000, 3000, 4000, 5000 and 10000 mg/kg bw/day At 2000 mg/kg bw/day and slight growth retardation was observed, all of the other dose groups lost weight rapidly.","effect":"rating OPP Sub-acute studies 1-month dietary study in rats (strain not specified) (5 females/ group); no guideline 0, 2000, 3000, 4000, 5000 and 10000 mg/kg bw/day At 2000 mg/kg bw/day and slight growth retardation was observed, all of the other dose groups lost weight rapidly. LOAEL: 2000 mg/kg bw/day Hodge et al., 1952 in (ECHA RAC, 2022)/KL2 32-day gavage study in male rats (15 males/ group); no guideline 0, 2, 20 and 200 mg/kg bw/day No treatment related adverse effects on any of parameters at any dose level. NOAEL: 200 mg/kg bw/day Macintosh, 1945 in (ECHA RAC, 2022)/KL2 13-day gavage study in New Zealand rabbits (2 females/ dose); similar to OECD 407 0, 100, 500 and 1000 mg/kg bw/day At 1000 mg/kg bw/day, ↓ final body weight, ↓ in food consumption was observed. At 500 mg/kg bw/day, changes in body weight, food consumption, absolute/relative, kidney and liver weight were observed. At 100 mg/kg bw/day, ↓ absolute/relative, liver weight. NOAEL: 100 mg/kg bw/day (ECHA, 2023b; ECHA RAC, 2022)/KL2 4-week gavage study in Beagle","page":65,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_024"}
SCCS_vision_codex NOAEL =100 mg/kg bw/day rabbit oral 13-day NOAEL study {"dose":"w/day No treatment related adverse effects on any of parameters at any dose level.","effect":"w/day No treatment related adverse effects on any of parameters at any dose level. NOAEL: 200 mg/kg bw/day Macintosh, 1945 in (ECHA RAC, 2022)/KL2 13-day gavage study in New Zealand rabbits (2 females/ dose); similar to OECD 407 0, 100, 500 and 1000 mg/kg bw/day At 1000 mg/kg bw/day, ↓ final body weight, ↓ in food consumption was observed. At 500 mg/kg bw/day, changes in body weight, food consumption, absolute/relative, kidney and liver weight were observed. At 100 mg/kg bw/day, ↓ absolute/relative, liver weight. NOAEL: 100 mg/kg bw/day (ECHA, 2023b; ECHA RAC, 2022)/KL2 4-week gavage study in Beagle dogs (2/sex/dose); no guideline 0, 100, 200, 300 (400 mg up to Day 5, lowered to 300 due to emesis) mg/kg bw/day 5 days/week for 4 weeks At 300 mg/kg bw/day, ↓ RBC, Hb, HCT and platelet was observed. At 200 mg/kg bw/day, dose-related emesis in all dogs, ↓ RBC and HCT count was observed. NOAEL: 100 mg/kg bw/day Cosse et al. in (EC, 2023; ECHA RAC, 2022)/KL2","page":65,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_025"}
SCCS_vision_codex NOAEL =2.5 % rat oral Sub-chronic repeated dose toxicity {"dose":"90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 66 Study type, Species Doses Key findings NOAEL or LOAEL Reference#/ KL rating Sub-chronic studie...","effect":"SCCS/1669/24 Final version Opinion on the safety of Biphenyl-2-ol and Sodium 2-biphenylolate (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 66 Study type, Species Doses Key findings NOAEL or LOAEL Reference#/ KL rating Sub-chronic studies 13-week dietary study in F344/DuCrj Rats (10/sex/group); similar to OECD TG 408 0, 0.156, 0.313, 0.625, 1.25, and 2.5% OPP equivalent to 0, 182, 391, 761, 1669, and 2798 mg/kg bw/day in males and 0, 202, 411, 803, 1650, and 3014 mg/kg bw/day in females At 2798/3014 mg/kg bw/day, ↓ body weight, terminal body weight, food and water consumption, changes in organ weight, and histopathological changes in the kidney and bladder, and ↓ Red Blood Count (RBC), Haemoglobin","page":66,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_027"}
SCCS_vision_codex NOAEL =761 mg/kg bw/day rat oral 3 months NOAEL study {"dose":"At 1669/1650 mg/kg bw/day, ↓ body weight, food, and water consumption, ↓Hb and MCH level and ↑ relative liver weight, relative kidney weight, absolute bladder weight and abnormal growth in the bladder mucosa was observed.","effect":"gical changes in the kidney and bladder, and ↓ Red Blood Count (RBC), Haemoglobin (Hb), Mean Corpuscular Volume (MCV), Mean Corpuscular Haemoglobin (MCH) and Mean Corpuscular Haemoglobin Concentration (MCHC) was observed. At 1669/1650 mg/kg bw/day, ↓ body weight, food, and water consumption, ↓Hb and MCH level and ↑ relative liver weight, relative kidney weight, absolute bladder weight and abnormal growth in the bladder mucosa was observed. At 761/ 803 mg/kg bw/day, changes in liver and kidney weight were observed. NOAEL: 761 mg/kg bw/day Iguchi et al., 1984 in (EC, 2023; ECHA, 2023b; ECHA RAC, 2022)/KL2 3 months dietary study (strain not specified) in rats (12/sex/group); no guideline 0, 100, 300, 1000 and 2000 mg/kg bw/day At 2000 mg/kg bw/day, slight growth retardation, ↑ liver, kidney and. in some rats (no numerical data available) At 1000 mg/kg bw/day, ↑ liver, kidney, and spleen weight in some rats (no numerical data available). NOAEL: 1000 mg/kg bw/day Hodge et al., 1952 in (ECHA RAC, 2022)/KL4 6 months gavage study (strain","page":66,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_028"}
SCCS_vision_codex NOAEL =1000 mg/kg bw/day rat oral 3 months NOAEL study {"dose":"At 761/ 803 mg/kg bw/day, changes in liver and kidney weight were observed.","effect":"a was observed. At 761/ 803 mg/kg bw/day, changes in liver and kidney weight were observed. NOAEL: 761 mg/kg bw/day Iguchi et al., 1984 in (EC, 2023; ECHA, 2023b; ECHA RAC, 2022)/KL2 3 months dietary study (strain not specified) in rats (12/sex/group); no guideline 0, 100, 300, 1000 and 2000 mg/kg bw/day At 2000 mg/kg bw/day, slight growth retardation, ↑ liver, kidney and. in some rats (no numerical data available) At 1000 mg/kg bw/day, ↑ liver, kidney, and spleen weight in some rats (no numerical data available). NOAEL: 1000 mg/kg bw/day Hodge et al., 1952 in (ECHA RAC, 2022)/KL4 6 months gavage study (strain not specified) in rats 0, 50, 100, 200 and 500 mg/kg bw/day 5 days/week At 500 mg/kg bw/day ↑ liver and kidney NOAEL: 200 mg/kg bw/day Hodge et al., 1952 in (ECHA, 2023b;","page":66,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_029"}
SCCS_vision_codex NOAEL =500 mg/kg bw/day dog oral Chronic NOAEL study {"dose":"Similar to OECD TG 409 0, 20, 200, and 500 mg/kg bw/day At 500 mg/kg bw/day, ↑ kidney weight in males (no numerical data) was observed.","effect":"SCCS/1669/24 Final version Opinion on the safety of Biphenyl-2-ol and Sodium 2-biphenylolate (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 67 Study type, Species Doses Key findings NOAEL or LOAEL Reference#/ KL rating (12/sex/group); no guideline weight (no numerical data available). ECHA RAC, 2022) /KL4 Chronic studies 1-year dietary study (strain not specified) in dogs (1- 2/sex/group); Similar to OECD TG 409 0, 20, 200, and 500 mg/kg bw/day At 500 mg/kg bw/day, ↑ kidney weight in males (no numerical data) was observed. NOAEL: 200 mg/kg bw/day Hodge et al., 1952 in (EC, 2023; ECHA, 2023b; ECHA RAC, 2022)/KL2 1 year gavage study in Beagle dogs (4/sex/group); Similar to OECD TG 409 0, 30, 100, and","page":67,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_031"}
SCCS_vision_codex NOAEL =4294 mg/kg bw/day mouse oral Sub-chronic repeated dose toxicity {"dose":"g bw/day) At 2000 mg/kg bw/day, an ↑ in dark- stained cells and a few mitoses were observed.","effect":"g bw/day) At 2000 mg/kg bw/day, an ↑ in dark- stained cells and a few mitoses were observed. The authors suggest that these changes are the prodromal stage of the tumours induced by SOPP after longer treatment periods. Only bladder examined (once/week by transmission electron microscopy (TEM). LOAEL: 2000 mg/kg bw/day Fukumori et al. in (SCCS, 2015)/KL2 Sub-chronic studies 13-week dietary study in B6C3F1 mice 0, 0.25, 0.5, 1.0, 2.0 and 4.0% (correspond- ding to At 5375/6349 mg/kg bw/day, ↓ body weight, ↓ mean food NOAEL: 3529 and 4294 mg/kg bw/day for males Shibata et al., 1981, 1985 in (SCCS, 2015)/KL2","page":67,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_035"}
SCCS_vision_codex NOAEL =5375 mg/kg bw/day rat oral 13-week NOAEL study {"dose":"90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 68 Study type, Species Doses Key findings NOAEL or LOAEL Reference#/ KL rating (10/sex/group); no...","effect":"SCCS/1669/24 Final version Opinion on the safety of Biphenyl-2-ol and Sodium 2-biphenylolate (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 68 Study type, Species Doses Key findings NOAEL or LOAEL Reference#/ KL rating (10/sex/group); no guideline weighted average doses of 0, 451, 902, 1581, 3529 and 5375 mg/kg bw/day in males and 0, 488, 976, 1926, 4294 and 6349 mg/kg bw/day in females, respectively) intake, ↑ urinary pH value and ↓ urine density. and females, respectively 13-week dietary study in F344 rats (10/sex/group); no guideline 0, 0.125, 0.25, 0.5, 1, 2 and 4% (corresponding to 0, 85, 177, 353, 706, 1384 and 2487 in males and 0, 87, 177, 352, 694, 1338 and 2431 mg/kg bw/day in females, res","page":68,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_036"}
SCCS_vision_codex NOAEL =353 mg/kg bw/day rat oral 13-week NOAEL study {"dose":"les, respectively) intake, ↑ urinary pH value and ↓ urine density. and females, respectively 13-week dietary study in F344 rats (10/sex/group); no guideline 0, 0.125, 0.25, 0.5, 1, 2 and 4% (corresponding to 0, 85, 177, 353, 706, 1384 and 2487 in males and 0, 87, 177, 352, 694, 1338 and 2431 mg/kg bw/day in females, respectively) At 2431/2487 mg...","effect":"les, respectively) intake, ↑ urinary pH value and ↓ urine density. and females, respectively 13-week dietary study in F344 rats (10/sex/group); no guideline 0, 0.125, 0.25, 0.5, 1, 2 and 4% (corresponding to 0, 85, 177, 353, 706, 1384 and 2487 in males and 0, 87, 177, 352, 694, 1338 and 2431 mg/kg bw/day in females, respectively) At 2431/2487 mg/kg bw/day, ↓ body weight, moderate pyelonephritis was observed. At 1338/1384 mg/kg bw/day, ↓ body weight was observed. At 694/706 mg/kg bw/day, ↓ body weight was observed. NOAEL: 353 mg/kg bw/day Iguchi et al., 1979 in (SCCS, 2015)/KL2 13-week dietary study in F344 rats (20/sex/group); no guideline 0, 0.625, 1.25, and 2.5% (correspond- ding to weighted average doses of 0, 625 1250 and 2500 in males and 0, 706, 1411 and 2823 mg/kg bw/day in females, respectively) At 2500/2823 mg/kg bw/day, ↓ body weight gain was observed. At 1250/1411 mg/kg bw/day, ↓ body weight gain was observed. NOAEL: 625 mg/kg bw/day Nakamura et al., 1981 in (SCCS, 2015)/KL2 90-day dietary study in male F344 rats (grou","page":68,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_037"}
SCCS_vision_codex NOAEL =625 mg/kg bw/day rat oral 13-week NOAEL study {"dose":"1338/1384 mg/kg bw/day, ↓ body weight was observed.","effect":"1338/1384 mg/kg bw/day, ↓ body weight was observed. At 694/706 mg/kg bw/day, ↓ body weight was observed. NOAEL: 353 mg/kg bw/day Iguchi et al., 1979 in (SCCS, 2015)/KL2 13-week dietary study in F344 rats (20/sex/group); no guideline 0, 0.625, 1.25, and 2.5% (correspond- ding to weighted average doses of 0, 625 1250 and 2500 in males and 0, 706, 1411 and 2823 mg/kg bw/day in females, respectively) At 2500/2823 mg/kg bw/day, ↓ body weight gain was observed. At 1250/1411 mg/kg bw/day, ↓ body weight gain was observed. NOAEL: 625 mg/kg bw/day Nakamura et al., 1981 in (SCCS, 2015)/KL2 90-day dietary study in male F344 rats (group not specified); no guideline 0 and 2% (correspond- ding to weighted average doses of 2000 mg/kg bw/day) At 2000 mg/kg bw/day, ↑ thickness of the bladder epithelium from Day 14 until end of study (classified as hyperplasia with accompanying increased frequency of cell infiltration) was observed. LOAEL: 2000 mg/kg bw/day Reitz et al., 1983 in (SCCS, 2015)/KL2","page":68,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_038"}
SCCS_vision_codex NOAEL =1865 mg/kg bw/day mouse dermal 4-week repeated dose toxicity {"dose":"90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 69 Dermal repeated dose toxicity studies Study type, Species Doses Key findings NOAEL or LOAEL Re...","effect":"SCCS/1669/24 Final version Opinion on the safety of Biphenyl-2-ol and Sodium 2-biphenylolate (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 69 Dermal repeated dose toxicity studies Study type, Species Doses Key findings NOAEL or LOAEL Reference#/ KL rating OPP 4-week dermal toxicity study in Swiss Webster CFW mice (10/sex/group); no guideline 0, 5.95, 11.4, 20.8, 35.7 and 55.5 mg / 0.1 mL acetone (corresponding to weighted average doses of 0, 383.1, 699.08, 1200 and 1865 mg/kg bw/day for males 0, 460.21, 839.70, 1441.20 and 2240.53 mg/kg bw/day for females respectively) 3 days/week Ulcerative lesions at the site of application were observed in all mice that received ≤20.8 mg; in 6/10 males and 9/10 females that received 11.4 mg; in 2/1","page":69,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_039"}
SCCS_vision_codex NOAEL =490 mg/kg bw/day rat oral - reproductive toxicity {"dose":"0, 40, 140 and 490 mg/kg bw/day Actual:","effect":"SCCS/1669/24 Final version Opinion on the safety of Biphenyl-2-ol and Sodium 2-biphenylolate (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 70 9.5 ANNEX 5. Reproductive and development toxicity Overview of reproductive toxicity studies Study type, Species Doses Critical effects NOAEL or LOAEL Reference#/ KL rating OPP Two- generation dietary reproductive toxicity study, CD Sprague- Dawley rats, (32-35/sex group) OECD TG 416 Nominal: 0, 40, 140 and 490 mg/kg bw/day Actual: 0, 35, 125 and 457 mg/kg bw/day for 2 generations Parental effects At 457 mg/kg bw/day, ↓ body weight, body weight gain and terminal body weight in males and females, ↑ relative weight of ovaries in females, ↑ Incidence of renal calculi and haemorrhage in males. ↑ Incidence of bladder calculi and urinary bladder transitional","page":70,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_042"}
SCCS_vision_codex NOAEL =35 mg/kg bw/day - - - reproductive toxicity {"dose":"ght of testes and kidney in males, ↑ Incidence of urinary bladder transitional cell hyperplasia in males At 125 mg/kg bw/day Parental effects ↑ in body weight gain and changes in food consumptions, ↑ relative weight of ovaries in females, ↑ Incidence of average number cells/layer in females and ↑ Incidence of bladder calculi in males were observed.","effect":"ght of testes and kidney in males, ↑ Incidence of urinary bladder transitional cell hyperplasia in males At 125 mg/kg bw/day Parental effects ↑ in body weight gain and changes in food consumptions, ↑ relative weight of ovaries in females, ↑ Incidence of average number cells/layer in females and ↑ Incidence of bladder calculi in males were observed. F1 effects ↑ Absolute weight of liver and kidney and testes in males, ↓ incidence of average number of cells/layers of urinary bladder were observed. At 35 mg/kg bw/day NOAEL (systemic toxicity): 35 mg/kg bw/day NOAEL (reproductive toxicity): 457 mg/kg bw/day NOAEL (offspring toxicity): 125 mg/kg bw/day Eigenberg et al., 1990 in (ECHA RAC, 2022; ECHA, 2023b; SCCS, 2015)/KL2","page":70,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_043"}
SCCS_vision_codex NOAEL =457 mg/kg bw/day - - - reproductive toxicity {"dose":"asia in males At 125 mg/kg bw/day Parental effects ↑ in body weight gain and changes in food consumptions, ↑ relative weight of ovaries in females, ↑ Incidence of average number cells/layer in females and ↑ Incidence of bladder calculi in males were observed.","effect":"asia in males At 125 mg/kg bw/day Parental effects ↑ in body weight gain and changes in food consumptions, ↑ relative weight of ovaries in females, ↑ Incidence of average number cells/layer in females and ↑ Incidence of bladder calculi in males were observed. F1 effects ↑ Absolute weight of liver and kidney and testes in males, ↓ incidence of average number of cells/layers of urinary bladder were observed. At 35 mg/kg bw/day NOAEL (systemic toxicity): 35 mg/kg bw/day NOAEL (reproductive toxicity): 457 mg/kg bw/day NOAEL (offspring toxicity): 125 mg/kg bw/day Eigenberg et al., 1990 in (ECHA RAC, 2022; ECHA, 2023b; SCCS, 2015)/KL2","page":70,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_045"}
SCCS_vision_codex NOAEL =92 mg/kg bw/day rat - chronic reproductive toxicity {"dose":"0, 20, 100 and 500 mg/kg bw/day Actual:","effect":"wley rats, (30/sex/group ) OECD TG 416 Nominal: 0, 20, 100 and 500 mg/kg bw/day Actual: 18/17, 93/92 and 459/457 mg/kg bw/day for males and females, respectively Parental effects At 459/457 mg/kg bw/day, no treatment-related increase in mortality, changes in body weight and terminal body weight, ↓ food consumption in males and females, ↑ incidence of histopathological alterations in males: in the urinary bladder; chronic Inflammation, nodular/papillary; simple hyperplasia, and the ureter dilatation and hyperplasia NOAEL (systemic and offspring toxicity): 92 mg/kg bw/day NOAEL (reproductive toxicity): 457 mg/kg bw/day Eigenberg and Lake 1995 in (ECHA RAC, 2022; ECHA, 2023b; SCCS, 2015)/KL1","page":71,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_047"}
SCCS_vision_codex NOAEL =2100 mg/kg bw/day mouse oral Developmental reproductive toxicity {"dose":"At 93/92 mg/kg bw/day, no statistically significant treatment related effects were observed in Parents and F1 Reproductive parameters At 459/457 mg/kg bw/day, Parents, F1 and F2 - ↑ fertility index during F2b generation, ↑ food consumption during gestation was observed However, this increase in the fertility index is considered an artifact due t...","effect":"ia, and kidney debris were observed. At 93/92 mg/kg bw/day, no statistically significant treatment related effects were observed in Parents and F1 Reproductive parameters At 459/457 mg/kg bw/day, Parents, F1 and F2 - ↑ fertility index during F2b generation, ↑ food consumption during gestation was observed However, this increase in the fertility index is considered an artifact due to the extremely low fertility index for the control group. Developmental toxicity studies Study type, Species Doses Critical effects NOAEL or LOAEL Reference#/ KL rating OPP Prenatal developmental toxicity via gavage in JCL- ICR mice, (21 females/group), similar to OCED TG 414 0, 1450, 1740 and 2100 mg/kg bw/day, GD 7-15 Maternal toxicity At 2100 mg/kg bw/day, ↑ mortality: 5 mice died on GD 8, 7 on GD 9 and 2 each on GD 11 and 12, ↓ body weight/body weight gain and ↓ in absolute/relative heart weight were observed. At 1740 mg/kg bw/day, ↑ LOAEL (maternal and developmental toxicity): 1450 mg/kg bw/day Ogata et al., 1978 in (EC, 2023; ECHA, 2023b; ECHA","page":72,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_050"}
SCCS_vision_codex NOAEL =1450 mg/kg bw/day mouse - - reproductive toxicity {"dose":"At 1450 mg/kg bw/day, ↑ mortality:","effect":"SCCS/1669/24 Final version Opinion on the safety of Biphenyl-2-ol and Sodium 2-biphenylolate (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 73 Study type, Species Doses Critical effects NOAEL or LOAEL Reference#/ KL rating mortality: 4 mice died on GD 7 and 1 each on GD 14, GD 15, and GD 16, ↓ body weight/body weight gain (no numerical data available), ↓ in absolute/relative heart weight and ↑ in relative liver weight. At 1450 mg/kg bw/day, ↑ mortality: 1 mouse died each on GD 11 and 15, 2 mice died on GD 16. ↑ in absolute/relative liver weight. Litter/reproductive data At 2100 mg/kg bw/day, ↓ foetal bodyweight, ↑ frequency of foetuses with cervical ribs, ↓ mean number of ossified left/right phalanges","page":73,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_051"}
SCCS_vision_codex NOAEL =300 mg/kg bw/day rat oral Prenatal developmental toxicity {"dose":"Prenatal developmental toxicity via gavage in SD rat, (25-35 females/group), similar to OCED TG 414 0, 100, 300 and 700 mg/kg bw/day, GD 6-15 Maternal toxicity At 700 mg/kg bw/day, ↓ body weight, body weight gain and absolute liver wight was observed.","effect":"↓ foetal body weight, ↑ frequency of foetuses with cervical ribs, ↓ mean number of ossified left/right phalanges in hindlegs, ↑ frequency of foetuses with externally visible malformations. Prenatal developmental toxicity via gavage in SD rat, (25-35 females/group), similar to OCED TG 414 0, 100, 300 and 700 mg/kg bw/day, GD 6-15 Maternal toxicity At 700 mg/kg bw/day, ↓ body weight, body weight gain and absolute liver wight was observed. At 300 mg/kg bw/day, decreased weight gain (not statistically significant) and NOAEL (maternal and evelopmental): 300 mg/kg bw/day (whereas SCCS has derived maternal NOAEL at 150 mg/kg bw/day) John et al., 1978 in (ECHA, 2023b)/KL2","page":73,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_052"}
SCCS_vision_codex NOAEL =150 mg/kg bw/day rat oral Prenatal developmental toxicity {"dose":"Prenatal developmental toxicity via gavage in SD rat, (25-35 females/group), similar to OCED TG 414 0, 100, 300 and 700 mg/kg bw/day, GD 6-15 Maternal toxicity At 700 mg/kg bw/day, ↓ body weight, body weight gain and absolute liver wight was observed.","effect":"fied left/right phalanges in hindlegs, ↑ frequency of foetuses with externally visible malformations. Prenatal developmental toxicity via gavage in SD rat, (25-35 females/group), similar to OCED TG 414 0, 100, 300 and 700 mg/kg bw/day, GD 6-15 Maternal toxicity At 700 mg/kg bw/day, ↓ body weight, body weight gain and absolute liver wight was observed. At 300 mg/kg bw/day, decreased weight gain (not statistically significant) and NOAEL (maternal and evelopmental): 300 mg/kg bw/day (whereas SCCS has derived maternal NOAEL at 150 mg/kg bw/day) John et al., 1978 in (ECHA, 2023b)/KL2","page":73,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_053"}
SCCS_vision_codex NOAEL =700 mg/kg bw/day rat oral Developmental developmental toxicity {"dose":"Developmental toxicity At 700 mg/kg bw/day, ↑Incidence of post- implantation loss in foetuses and litters were observed.","effect":"SCCS/1669/24 Final version Opinion on the safety of Biphenyl-2-ol and Sodium 2-biphenylolate (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 74 Study type, Species Doses Critical effects NOAEL or LOAEL Reference#/ KL rating reduced food consumption was observed. Developmental toxicity At 700 mg/kg bw/day, ↑Incidence of post- implantation loss in foetuses and litters were observed. Skeletal alteration: ↑Incidence foetuses with: Delayed ossification of sternebrae foetuses, skull foramen, skull bone island Prenatal developmental toxicity via gavage in Wistar rats, (11-20 females/group), similar to OCED TG 414 0, 150, 300, 600 and 1200 mg/kg bw/day, GD 6-15 Maternal toxicity At 1200 mg/kg bw/day, 10/11 dams","page":74,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_054"}
SCCS_vision_codex NOAEL =600 mg/kg bw/day rat oral Developmental developmental toxicity {"dose":"At 600 mg/kg bw/day, ↓ body weight gain, clinical signs such as pregnant rats fell into ataxia for several hours.","effect":"xia for several hours. At 600 mg/kg bw/day, ↓ body weight gain, clinical signs such as pregnant rats fell into ataxia for several hours. At 300 mg/kg bw/day, ↓ body weight gain, clinical signs such as pregnant rats fell into ataxia for several hours. Developmental toxicity At 600 mg/kg bw/day, ↑ percentage of foetal death, ↓ mean foetal weight, ↑ foetal incidence of malformations. At 300 mg/kg bw/day, ↑ foetal incidence of malformations NOAEL (maternal and developmental): 150 mg/kg bw/day Note: SCCS considered the NOAEL for developmental at 600 mg/kg bw/day) Kaneda et al., 1978 in (ECHA, 2023b; ECHA RAC, 2022; SCCS, 2015)/KL2 Range finding Prenatal developmental toxicity via gavage in New Zealand rabbits, (7 females/ group), no guideline 0, 250, 500 and 750 mg/ kg bw/day GD 7-19 Maternal toxicity At 750 mg/kg bw/day, mortality: nine rabbits died prior to study termination. Two rabbits (one at 500 and one at 750 mg/kg bw/day) were found withdepositions of the test material in the lungs. The remaining deaths were considered treatme","page":74,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_056"}
SCCS_vision_codex NOAEL =400 mg/ kg bw/ day mouse oral Prenatal developmental toxicity {"dose":"90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 76 Study type, Species Doses Critical effects NOAEL or LOAEL Reference#/ KL rating SOPP Prenatal...","effect":"SCCS/1669/24 Final version Opinion on the safety of Biphenyl-2-ol and Sodium 2-biphenylolate (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 76 Study type, Species Doses Critical effects NOAEL or LOAEL Reference#/ KL rating SOPP Prenatal developmental toxicity via gavage in JCL- ICR mice, (20 females/group), similar to OCED TG 414 0, 100, 200 and 400 mg/ kg bw/ day, GD 7-15 Maternal toxicity At 400 mg/kg bw/day, ↑ mortality (80% of unscheduled deaths), ↓ body weight and body weight gain, ↓ absolute weight of liver, heart, and spleen. At 200 mg/kg bw/day, ↑ mortality (20% of unscheduled deaths), ↓ body weight and body weight gain, ↑ relative lung weight at 100 mg/kg bw/day, ↓ body weight and body wei","page":76,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_061"}
SCCS_vision_codex NOAEL =269 mg/kg bw/day rat - 2-year carcinogenicity {"dose":"At 531 mg/kg bw/day, haematuria, ↓body weights, proliferative lesions in the urinary bladder, and moderate to severe nephritic lesions and urinary bladder tumours (papilloma and carcinoma, mainly transitional cell papilloma and carcinoma) were observed.","effect":"/day, ↑white blood cell count, haematuria, ↓body weights, proliferative lesions in the urinary bladder, and moderate to severe nephritic lesions and urinary bladder tumours (papilloma and carcinoma, mainly transitional cell papilloma and carcinoma). were observed. At 531 mg/kg bw/day, haematuria, ↓body weights, proliferative lesions in the urinary bladder, and moderate to severe nephritic lesions and urinary bladder tumours (papilloma and carcinoma, mainly transitional cell papilloma and carcinoma) were observed. NOAEL (carcinogenicity): 269 mg/kg bw/day Hiraga K., and Fujii T. 1984 in (EC, 2023; ECHA, 2023b; ECHA RAC, 2022; SCCS, 2015)/KL2 2-year combined chronic toxicity/ carcinogenicity study in CDF[F344]/BR rats 0, 800, 4000 and 8000/ 10000 ppm (equivalent to 0, 39/49, 200/248 and 402/647 mg/kg bw/day in At 402/647 mg/kg bw/day, ↑ incidence of urinary bladder masses, ↑ incidence of pitted zones in kidneys. Neoplastic changes such as ↑ incidence of transitional NOAEL (carcinogenicity and systemic toxicity): 39 and 49 mg/kg bw","page":93,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_067"}
SCCS_vision_codex NOAEL =248 mg/kg bw/day - - - NOAEL study {"dose":"At 200/248 mg/kg bw/day, neoplastic changes in the urinary bladder, such as ↑ incidence of transitional cell carcinomas in males, ↓ body weight, body weight gain, food consumption and food efficiency, ↑clinical signs and gross pathological signs of toxicity. and females, respectively SCCS, 2015;","effect":"SCCS/1669/24 Final version Opinion on the safety of Biphenyl-2-ol and Sodium 2-biphenylolate (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 94 Study type, Species Doses Key findings NOAEL/ LOAEL Reference / KL rating (50/sex/group); OECD TG 453 males/females, respectively cell carcinomas, ↑ incidence of papillomas in males was observed. Non-neoplastic changes in the urinary bladder and kidney were observed. At 200/248 mg/kg bw/day, neoplastic changes in the urinary bladder, such as ↑ incidence of transitional cell carcinomas in males, ↓ body weight, body weight gain, food consumption and food efficiency, ↑clinical signs and gross pathological signs of toxicity. and females, respectively SCCS, 2015;","page":94,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_069"}
SCCS_vision_codex NOAEL =3081 mg/kg bw/day - oral 96-week NOAEL study {"dose":"Systemically, slightly increased incidences of dilatation of the kidney tubules compared to acetone controls were observed in OPP treated animals.","effect":"effect. Systemically, slightly increased incidences of dilatation of the kidney tubules compared to acetone controls were observed in OPP treated animals. In males, a greater incidence of focal necrosis of the liver (of mild degree) was observed. OPP, alone or after tumour initiation with DMBA, did not increase the incidence of neoplastic skin lesions when applied dermally over two years National Toxicology Program, 1986 in (SCCS, 2015)/KL2 SOPP Oral 96-week dietary 0, 0.5, 1.0 and 2.0% At 3009/3081 mg/kg bw/day, NOAEL Hagiwara et","page":94,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_071"}
SCCS_vision_codex NOAEL =3009 mg/kg bw/day mouse - - NOAEL study {"dose":"90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 95 Study type, Species Doses Key findings NOAEL/ LOAEL Reference / KL rating study in B6C3F1 mice...","effect":"SCCS/1669/24 Final version Opinion on the safety of Biphenyl-2-ol and Sodium 2-biphenylolate (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 95 Study type, Species Doses Key findings NOAEL/ LOAEL Reference / KL rating study in B6C3F1 mice (50/sex/group); no guideline equivalent to 0, 591, 1451, and 3009 mg/kg bw/day for the males and 0, 480, 1464, and 3081 mg/kg bw/day for the females, respectively ↑hepatocellular carcinomas and calcification of the brain were observed. At 1451/1464 mg/kg bw/day ↑ haemangiosarcomas of the liver, ↑hepatocellular carcinomas were observed. At 480 mg/kg bw/day, cystic endometrial hyperplasia of the uterus in females was observed in females. Authors considered increased","page":95,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_072"}
SCCS_vision_codex NOAEL =125 mg/kg bw/day - oral 2-year carcinogenicity {"dose":"no guideline 0, 0.125, 0.25, 0.5, 1.0, 2.0 and 4.0% equivalent to 0, 62, 125, 250, 500, 1000 and 2000 mg/kg bw/dayk At 2000 mg/kg bw/day, ↑incidence of carcinoma in the renal papilla was observed.","effect":"no guideline 0, 0.125, 0.25, 0.5, 1.0, 2.0 and 4.0% equivalent to 0, 62, 125, 250, 500, 1000 and 2000 mg/kg bw/dayk At 2000 mg/kg bw/day, ↑incidence of carcinoma in the renal papilla was observed. At 1000 mg/kg bw/day, ↑ in the incidence of tumours of the urinary system and carcinosarcoma was observed. At 500 mg/kg bw/day, ↑in the incidence of tumours of the urinary system was observed. At 250 mg/kg bw/day, ↑in the incidence of tumours of the urinary system was observed. Haematuria was observed at all dose levels. NOAEL (carcinogenicity): 125 mg/kg bw/day LOAEL (systemic toxicity): 62 mg/kg bw/day Hiraga et al..., 1981 in (SCCS, 2015)/KL2 2-year dietary carcinogenicity 1st study: Males: 0, 7000 and 20000 ppm, At 466/770 mg/kg bw/day, ↑ focal atrophy of the LOAEL (carcinogenicity Hiraga et al..., 1983 in (SCCS,","page":95,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_073"}
SCCS_vision_codex NOAEL =770 mg/kg bw/day rat - - NOAEL study {"dose":"90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 96 Study type, Species Doses Key findings NOAEL/ LOAEL Reference / KL rating study in F344 rats (...","effect":"SCCS/1669/24 Final version Opinion on the safety of Biphenyl-2-ol and Sodium 2-biphenylolate (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 96 Study type, Species Doses Key findings NOAEL/ LOAEL Reference / KL rating study in F344 rats (50/sex/group); no guideline equivalent to 0, 270 and 770 mg/kg bw/day, respectively) and Females: 0, 5000 and 10000 ppm equivalent to 0, 224 and 466 mg/kg bw/day, respectively pancreas and ↑ incidences of interstitial nephritis of the kidney were observed. At 466/770 mg/kg bw/day in the kidneys, both non- neoplastic changes (interstitial nephritis and pyelonephritis) and neoplastic changes (transitional cell papilloma and carcinoma) occurred in low incidences in the","page":96,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_074"}
SCCS_vision_codex NOAEL =395 mg/kg bw/day rat - 2-year carcinogenicity {"dose":"95 mg/kg bw/day 2-year carcinogenicity study in male F344 rats (groups not specified); no guideline 0, 0.25, 0.5, 1.0 and 2.0% equivalent to approximately 0, 197, 395, 780 and 1579 mg/kg bw/dayl At 1579 mg/kg bw/day, hyperplasia of bladder was observed.","effect":"kidney, urinary bladder papillomas and/or carcinomas were observed. NOAEL (carcinogenicity and systemic toxicity): 95 mg/kg bw/day 2-year carcinogenicity study in male F344 rats (groups not specified); no guideline 0, 0.25, 0.5, 1.0 and 2.0% equivalent to approximately 0, 197, 395, 780 and 1579 mg/kg bw/dayl At 1579 mg/kg bw/day, hyperplasia of bladder was observed. Development of papilloma and carcinoma was observed after 36 weeks. At 780 mg/kg bw/day, development of simple hyperplasia from week 36 was observed. NOAEL (carcinogenicity and systemic toxicity): 395 mg/kg bw/day Fukushima et al..., 1982 in (SCCS, 2015)/KL4 112-week carcinogenicity 0, 2500, 5000, 10000, 15000 and 20000 ppm At 1500 mg/kg bw/day, transitional cell carcinoma NOAEL (carcinogenicity Niho et al..., 2002 in (SCCS,","page":96,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_076"}
SCCS_vision_codex NOAEL =1500 mg/kg bw/day - - 36 weeks carcinogenicity {"dose":".5, 1.0 and 2.0% equivalent to approximately 0, 197, 395, 780 and 1579 mg/kg bw/dayl At 1579 mg/kg bw/day, hyperplasia of bladder was observed.","effect":".5, 1.0 and 2.0% equivalent to approximately 0, 197, 395, 780 and 1579 mg/kg bw/dayl At 1579 mg/kg bw/day, hyperplasia of bladder was observed. Development of papilloma and carcinoma was observed after 36 weeks. At 780 mg/kg bw/day, development of simple hyperplasia from week 36 was observed. NOAEL (carcinogenicity and systemic toxicity): 395 mg/kg bw/day Fukushima et al..., 1982 in (SCCS, 2015)/KL4 112-week carcinogenicity 0, 2500, 5000, 10000, 15000 and 20000 ppm At 1500 mg/kg bw/day, transitional cell carcinoma NOAEL (carcinogenicity Niho et al..., 2002 in (SCCS,","page":96,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_077"}
SCCS_vision_codex NOAEL =2000 mg/kg bw/day rat dermal 52-week NOAEL study {"dose":"90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 97 Study type, Species Doses Key findings NOAEL/ LOAEL Reference / KL rating study in male F344 r...","effect":"SCCS/1669/24 Final version Opinion on the safety of Biphenyl-2-ol and Sodium 2-biphenylolate (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 97 Study type, Species Doses Key findings NOAEL/ LOAEL Reference / KL rating study in male F344 rats (50 /group) equivalent to approximately 250, 500, 1000, 1500 and 2000 mg/kg bw/day was observed in rats. At 1500 mg/kg bw/day and above, urinary bladder tumour formation was observed. and systemic toxicity): 1000 mg/kg bw/day 2015{Cal EPA, 2007 #4752)} /KL2 Dermal 52-week, two- stage mouse skin carcinogenesis study in female CD-1 mice Initiation: SOPP in DMSO (10 mg/100 µL) or DMBA ( (10 µg/100 µl) twice weekly for 5 weeks. Promotion: starting 1 week after last","page":97,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_078"}
SCCS_vision_codex NOAEL =224 mg/kg bw/day rat - - carcinogenicity {"dose":"In the first study, the LOAEL for systemic toxicity and carcinogenicity was established at 270 and 224 mg/kg bw/day in males and females, respectively.","effect":"isher Exact test, as calculated by DPR in Cal EPA, 2007: significant at p<0.05, p<0.01, p<0.001, respectively. +,++,+++ Cochran-Armitage trend test, as calculated by DPR in Cal EPA, 2007; significant at p<0.05, p<0.01, and p<0.001, respectively. Conclusion Under the study conditions, SOPP was assessed to be carcinogenic in Fischer 344 rats. In the first study, the LOAEL for systemic toxicity and carcinogenicity was established at 270 and 224 mg/kg bw/day in males and females, respectively. In the second study, the NOAEL for both systemic toxicity and carcinogenicity was established at 95 and 113 mg/kg bw/day in males and females, respectively. Note: The non-neoplastic changes such as interstitial nephritis and pyelonephritis and neoplastic changes such as transitional cell papilloma and carcinoma in the kidneys and carcinomas/papilloma induced in the bladder at 224/270 mg/kg bw/day did not reach statistical significance. However, in their evaluation, Cal EPA (2007) considered the observations to be treatment-related findings beca","page":102,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_081"}
SCCS_vision_codex NOAEL =65 - - - - NOAEL study {"effect":"Unlabeled table on page 65: Study type, | Doses | Key findings | NOAEL or | Reference#/ KL rating","page":65,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_082"}
SCCS_vision_codex NOAEL =66 - - - - NOAEL study {"effect":"Unlabeled table on page 66: Study type, Species | Doses | Key findings | NOAEL or LOAEL | Reference#/ KL rating","page":66,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_089"}
SCCS_vision_codex NOAEL =67 - - - - NOAEL study {"effect":"Unlabeled table on page 67: Study type, Species | Doses | Key findings | NOAEL or LOAEL | Reference#/ KL rating","page":67,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_096"}
SCCS_vision_codex NOAEL =4 % mouse oral 13-week NOAEL study {"dose":"13-week dietary study in B6C3F1 mice | 0, 0.25, 0.5, 1.0, 2.0 and 4.0% (correspond- ding to | At 5375/6349 mg/kg bw/day, ↓ body weight, ↓ mean food | NOAEL:","effect":"Unlabeled table on page 67: 13-week dietary study in B6C3F1 mice | 0, 0.25, 0.5, 1.0, 2.0 and 4.0% (correspond- ding to | At 5375/6349 mg/kg bw/day, ↓ body weight, ↓ mean food | NOAEL: 3529 and 4294 mg/kg bw/day for males | Shibata et al., 1981, 1985 in (SCCS, 2015)/KL2","page":67,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_099"}
SCCS_vision_codex NOAEL =68 - - - - NOAEL study {"effect":"Unlabeled table on page 68: Study type, Species | Doses | Key findings | NOAEL or LOAEL | Reference#/ KL rating","page":68,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_104"}
SCCS_vision_codex NOAEL =69 - - - - NOAEL study {"effect":"Unlabeled table on page 69: Study type, Species | Doses | Key findings | NOAEL or LOAEL","page":69,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_111"}
SCCS_vision_codex NOAEL =240 mg/kg bw/day mouse dermal 4-week NOAEL study {"dose":"4-week dermal toxicity study in Swiss Webster CFW mice (10/sex/group); no guideline | 0, 5.95, 11.4, 20.8, 35.7 and 55.5 mg / 0.1 mL acetone (corresponding to weighted average doses of 0, 383.1, 699.08, 1200 and 1865 mg/kg bw/day for males 0, 460.21, 839.70, 1441.20 and 2240.53 mg/kg bw/day for females respectively) 3 days/week | Ulcerative lesi...","effect":"Unlabeled table on page 69: 4-week dermal toxicity study in Swiss Webster CFW mice (10/sex/group); no guideline | 0, 5.95, 11.4, 20.8, 35.7 and 55.5 mg / 0.1 mL acetone (corresponding to weighted average doses of 0, 383.1, 699.08, 1200 and 1865 mg/kg bw/day for males 0, 460.21, 839.70, 1441.20 and 2240.53 mg/kg bw/day for females respectively) 3 days/week | Ulcerative lesions at the site of application were observed in all mice that received ≤20.8 mg; in 6/10 males and 9/10 females that received 11.4 mg; in 2/10 males and 7/10 females that received 5.95 mg, and in 1/10 male and 1/10 female of control group | LOAEL (dermal toxicity): 5.95 mg (equivalent to 200 / 240 mg/kg bw/day for males and females, respectively) | NTP, 1986 in ECHA RAC, 2022/KL2","page":69,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_113"}
SCCS_vision_codex NOAEL =70 - - - - NOAEL study {"effect":"Unlabeled table on page 70: Study type, Species | Doses | Critical effects | NOAEL or LOAEL | Reference#/ KL rating","page":70,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_115"}
SCCS_vision_codex NOAEL =71 - - - - NOAEL study {"effect":"Unlabeled table on page 71: Study type, Species | Doses | Critical effects | NOAEL or LOAEL | Reference#/ KL rating","page":71,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_118"}
SCCS_vision_codex NOAEL =72 - - - - NOAEL study {"effect":"Unlabeled table on page 72: Study type, Species | Doses | Critical effects | NOAEL or LOAEL | Reference#/ KL rating","page":72,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_121"}
SCCS_vision_codex NOAEL =73 - - - - NOAEL study {"effect":"Unlabeled table on page 73: Study type, Species | Doses | Critical effects | NOAEL or LOAEL | Reference#/ KL rating","page":73,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_123"}
SCCS_vision_codex NOAEL =74 - - - - NOAEL study {"effect":"Unlabeled table on page 74: Study type, Species | Doses | Critical effects | NOAEL or LOAEL | Reference#/ KL rating","page":74,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_126"}
SCCS_vision_codex NOAEL =1200 mg/kg bw/day rat oral Prenatal developmental toxicity {"dose":"Prenatal developmental toxicity via gavage in Wistar rats, (11-20 females/group), similar to OCED TG 414 | 0, 150, 300, 600 and 1200 mg/kg bw/day, GD 6-15 | Maternal toxicity At 1200 mg/kg bw/day, 10/11 dams died after 3-9 days of treatment, clinical signs such as pregnant rats fell into ataxia for several hours.","effect":"Unlabeled table on page 74: Prenatal developmental toxicity via gavage in Wistar rats, (11-20 females/group), similar to OCED TG 414 | 0, 150, 300, 600 and 1200 mg/kg bw/day, GD 6-15 | Maternal toxicity At 1200 mg/kg bw/day, 10/11 dams died after 3-9 days of treatment, clinical signs such as pregnant rats fell into ataxia for several hours. At 600 mg/kg bw/day, ↓ body weight gain, clinical signs such as pregnant rats fell into ataxia for several hours. At 300 mg/kg bw/day, ↓ body weight gain, clinical signs such as pregnant rats fell into ataxia for several hours. Developmental toxicity At 600 mg/kg bw/day, ↑ percentage of foetal death, ↓ mean foetal weight, ↑ foetal incidence of malformations. At 300 mg/kg bw/day, ↑ foetal incidence of malformations | NOAEL (maternal and developmental): 150 mg/kg bw/day Note: SCCS considered the NOAEL for developmental at 600 mg/kg bw/day) | Kaneda et al., 1978 in (ECHA, 2023b; ECHA RAC, 2022; SCCS, 2015)/KL2","page":74,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_127"}
SCCS_vision_codex NOAEL =750 mg/ kg bw/day rabbit oral Prenatal developmental toxicity {"dose":"Range finding Prenatal developmental toxicity via gavage in New Zealand rabbits, (7 females/ group), no guideline | 0, 250, 500 and 750 mg/ kg bw/day GD 7-19 | Maternal toxicity At 750 mg/kg bw/day, mortality: nine rabbits died prior to study termination.","effect":"Unlabeled table on page 74: Range finding Prenatal developmental toxicity via gavage in New Zealand rabbits, (7 females/ group), no guideline | 0, 250, 500 and 750 mg/ kg bw/day GD 7-19 | Maternal toxicity At 750 mg/kg bw/day, mortality: nine rabbits died prior to study termination. Two rabbits (one at 500 and one at 750 mg/kg bw/day) were found withdepositions of the test material in the lungs. The remaining deaths were considered treatment related. ↓ body weight and | LOAEL (maternal toxicity): 250 mg/kg bw/day; Developmental NOAEL cannot be established, since foetuses were not examined for skeletal, visceral, and external anomalies | Zablotny et al., 1991, in (ECHA RAC, 2022; SCCS, 2015) /KL2","page":74,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_128"}
SCCS_vision_codex NOAEL =75 - - - - NOAEL study {"effect":"Unlabeled table on page 75: Study type, Species | Doses | Critical effects | NOAEL or LOAEL | Reference#/ KL rating","page":75,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_131"}
SCCS_vision_codex NOAEL =76 - - - - NOAEL study {"effect":"Unlabeled table on page 76: Study type, Species | Doses | Critical effects | NOAEL or LOAEL | Reference#/ KL rating","page":76,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_134"}
SCCS_vision_codex NOAEL =93 - - - - NOAEL study {"effect":"Unlabeled table on page 93: Study type, Species | Doses | Key findings | NOAEL/ LOAEL | Reference / KL rating","page":93,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_136"}
SCCS_vision_codex NOAEL =10000 ppm rat - 2-year carcinogenicity {"dose":"2-year combined chronic toxicity/ carcinogenicity study in CDF[F344]/BR rats | 0, 800, 4000 and 8000/ 10000 ppm (equivalent to 0, 39/49, 200/248 and 402/647 mg/kg bw/day in | At 402/647 mg/kg bw/day, ↑ incidence of urinary bladder masses, ↑ incidence of pitted zones in kidneys.","effect":"Unlabeled table on page 93: 2-year combined chronic toxicity/ carcinogenicity study in CDF[F344]/BR rats | 0, 800, 4000 and 8000/ 10000 ppm (equivalent to 0, 39/49, 200/248 and 402/647 mg/kg bw/day in | At 402/647 mg/kg bw/day, ↑ incidence of urinary bladder masses, ↑ incidence of pitted zones in kidneys. Neoplastic changes such as ↑ incidence of transitional | NOAEL (carcinogenicity and systemic toxicity): 39 and 49 mg/kg bw/day in males | Wahle et al...,1996 in (ECHA, 2023b; ECHA RAC, 2022;","page":93,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_139"}
SCCS_vision_codex NOAEL =94 - - - - NOAEL study {"effect":"Unlabeled table on page 94: Study type, Species | Doses | Key findings | NOAEL/ LOAEL | Reference / KL rating","page":94,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_143"}
SCCS_vision_codex NOAEL =2 % rat - 2-year carcinogenicity {"dose":"Similar to OECD TG 453 | 0, 0.02, 0.2 and 2% equivalent to 0, 10, 100 and 1000 mg/kg bw/day | At 1000 mg/kg bw/day, ↓ body weight, ↑weight of testes and histopathological changes such as extensive renal damage, characterised by tubular dilation with varying degrees of acute and chronic inflammation was observed. | NOAEL:","effect":"Unlabeled table on page 94: 2-year combined chronic toxicity/ carcinogenicity study in weanling Rochester rats (25/sex/group); Similar to OECD TG 453 | 0, 0.02, 0.2 and 2% equivalent to 0, 10, 100 and 1000 mg/kg bw/day | At 1000 mg/kg bw/day, ↓ body weight, ↑weight of testes and histopathological changes such as extensive renal damage, characterised by tubular dilation with varying degrees of acute and chronic inflammation was observed. | NOAEL: 100 mg/kg bw/day | Hodge HC., et al... 1952 in (EC, 2023)/KL2","page":94,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_144"}
SCCS_vision_codex NOAEL =95 - - - - NOAEL study {"effect":"Unlabeled table on page 95: Study type, Species | Doses | Key findings | NOAEL/ LOAEL | Reference / KL rating","page":95,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_148"}
SCCS_vision_codex NOAEL =20000 ppm - oral 2-year carcinogenicity {"dose":"0, 7000 and 20000 ppm, | At 466/770 mg/kg bw/day, ↑ focal atrophy of the | LOAEL (carcinogenicity | Hiraga et al..., 1983 in (SCCS,","effect":"Unlabeled table on page 95: 2-year dietary carcinogenicity | 1st study: Males: 0, 7000 and 20000 ppm, | At 466/770 mg/kg bw/day, ↑ focal atrophy of the | LOAEL (carcinogenicity | Hiraga et al..., 1983 in (SCCS,","page":95,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_152"}
SCCS_vision_codex NOAEL =96 - - - - NOAEL study {"effect":"Unlabeled table on page 96: Study type, Species | Doses | Key findings | NOAEL/ LOAEL | Reference / KL rating","page":96,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_153"}
SCCS_vision_codex NOAEL =97 - - - - NOAEL study {"effect":"Unlabeled table on page 97: Study type, Species | Doses | Key findings | NOAEL/ LOAEL | Reference / KL rating","page":97,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_160"}
SCCS_vision_codex NOAEL >98 % rat oral 24 months NOAEL study {"citation":"Ref.: 106 SCCS comment Due to poor reporting the study cannot be used to derive a NOAEL","dose":"Decreased (p<0.01) body weights occurred in males (10 %) and females (6 %) at 20000 ppm.","effect":"SCCS-rejected applicant NOAEL: rol groups, only 22-32 % of the animals were alive at the end of 24 months. Decreased (p<0.01) body weights occurred in males (10 %) and females (6 %) at 20000 ppm. Another effect observed at the highest dose level was increased relative testis weight (46 %). Extensive renal damage characterised by marked tubular dilation with varying degrees of acute and chronic inflammation was found in male and female animals at the highest dose. Ref.: 106 SCCS comment Due to poor reporting the study cannot be used to derive a NOAEL. In a study from the open literature, Dowicide 1 (Lot MM01040, purity > 98 %) was administered for 91 weeks to male F344/DuCrj rats at dietary concentrations of 0, 0.625, 1.25 and 2.5 % corresponding to 0, 269, 531 and 1140 mg/kg bw/d. Survival was 100 %, 71 % (p < 0.05) and 65 % (p < 0.05) at 269, 531 and 1140 mg/kg bw/d, respectively. The following findings were observed in treated animals: increased (20 %) white blood cell count at the highest dose, hematuria at 531 and 1140 mg/kg bw/d, increased water intake","page":24,"pdf":"sccs_o_177.pdf","row_type":"noael_study","study_id":"sccs_o_177_noael_001"}
SCCS_vision_codex NOAEL =92 mg/kg/day mouse - - NOAEL study {"citation":"Ref.: 165, 166 SCCS conclusion Apparently the study was not performed according to an accepted guideline","dose":"ion to the increased incidence, the lesion severity (e.g., tubular epithelium degeneration) also appeared to increase with dose.","effect":"ion to the increased incidence, the lesion severity (e.g., tubular epithelium degeneration) also appeared to increase with dose. Reduced (p<0.05) absolute kidney weights occurred in each of the OPP-treated groups (7-24 %), but the dose-response seemed consistent with the general body weight reductions noted in these groups (12-43 %). Based on the induction of renal tubular epithelium degeneration, spleen atrophy, increased water intake, and increased relative liver weight, occurring at each concentration tested, a NOAEL cannot be derived. 92 mg/kg/day can be considered as LOAEL. Ref.: 165, 166 SCCS conclusion Apparently the study was not performed according to an accepted guideline. Only male animals were used in the study. The study can be used as supporting information about OPP target tissues in mice. Tumour incidences in the liver did not represent a dose response. Types of liver cancers were not reported. Guideline: OECD TG 453 Species/strain: mouse, B6C3F1 Group size: 50/sex/dose (main group) 10/sex/dose (satellite grou","page":25,"pdf":"sccs_o_177.pdf","row_type":"noael_study","study_id":"sccs_o_177_noael_002"}
SCCS_vision_codex NOAEL =250 mg/kg bw/d mouse oral 5d NOAEL study {"citation":"Ref.: 220, 221 In a GLP-compliant study four groups of beagle dogs (4 animals/sex/dose) received OPP (purity 99","dose":"ignificantly increased in livers of male mice, however, a statistically significant increase in hepatocellular adenoma was observed at the two highest doses (27/50 in controls, 33/50 at 250 mg/kg, 40/50 at 500 mg/kg, and 41/50 at 1000 mg/kg).","effect":"ignificantly increased in livers of male mice, however, a statistically significant increase in hepatocellular adenoma was observed at the two highest doses (27/50 in controls, 33/50 at 250 mg/kg, 40/50 at 500 mg/kg, and 41/50 at 1000 mg/kg). In female mice, also microscopic changes in livers were seen, however, no female mouse had a hepatoblastoma and there were no statistically significant increases in liver or other tumours in the female animals. As treatment-related effects were observed in all dose groups, no NOAEL can be derived from this study. The LOAEL is considered to be 250 mg/kg bw/d. SCCS comment In this study in mice, the heart was not identified as a target organ. CalEpa considered the incidence of hepatoblastoma at the mid dose as treatment-related due to its rare spontaneous occurrence in this strain. Ref.: 220, 221 In a GLP-compliant study four groups of beagle dogs (4 animals/sex/dose) received OPP (purity 99.77 %, identification #8800005-24) at gavage doses of 0, 30, 100, or 300 mg/kg bw/d, 5d / week, for","page":26,"pdf":"sccs_o_177.pdf","row_type":"noael_study","study_id":"sccs_o_177_noael_003"}
SCCS_vision_codex NOAEL >300 mg/kg/day mouse oral 5d NOAEL study {"citation":"Ref.: 220, 221 In a GLP-compliant study four groups of beagle dogs (4 animals/sex/dose) received OPP (purity 99","dose":"incidence of hepatoblastoma at the mid dose as treatment-related due to its rare spontaneous occurrence in this strain.","effect":"incidence of hepatoblastoma at the mid dose as treatment-related due to its rare spontaneous occurrence in this strain. Ref.: 220, 221 In a GLP-compliant study four groups of beagle dogs (4 animals/sex/dose) received OPP (purity 99.77 %, identification #8800005-24) at gavage doses of 0, 30, 100, or 300 mg/kg bw/d, 5d / week, for one year. There were no effects on body weight, feed consumption, ophthalmology, haematology, urinalysis, and pathology. The only clinical sign was vomiting (dose-dependent increase). A NOAEL > 300 mg/kg/day can be derived from this study. Ref.: 32 Dermal mouse Swiss CD-1 mice (50/sex) received repeated dermal applications of 55 mg OPP (99 % purity, lot MM09157), dissolved in 0.1 ml acetone solution for 102 weeks. Treatment did not affect survival and body weight. No skin neoplasms occurred in mice dosed with OPP, however non-neoplastic lesions (ulcer, active chronic inflammation, hyperkeratosis and acanthosis) were observed at the application site. Systemically, slightly increased incidences of di","page":26,"pdf":"sccs_o_177.pdf","row_type":"noael_study","study_id":"sccs_o_177_noael_004"}
SCCS_vision_codex NOAEL =39 mg/kg bw/d rat oral 2-year reproductive toxicity {"citation":"(Ref. 303)","dose":"303), a NOAEL of 39 mg/kg bw/d was obtained based on urinary bladder hyperplasia and urinary bladder transitional cell carcinoma.","effect":"OPP) • Species- and strain-specific differences (OPP-induced bladder tumours were not observed in female rats, mice, dogs) • dermal application to mice does not affect tumour incidence in skin • no skin tumour development induced by OPP metabolites • tumours occur at high doses when sulfate and glucuronide conjugation pathways are saturated The threshold for OPP-induced bladder tumours can be approached from different studies all yielding a quite consistent picture: In a 2-year bioassay in F344 rats (Ref. 303), a NOAEL of 39 mg/kg bw/d was obtained based on urinary bladder hyperplasia and urinary bladder transitional cell carcinoma. In a study investigating cytotoxicity and regenerative hyperplasia in male F344 rats fed different levels of OPP (Ref. 263), no effects were observed at a dose level of 0.08 % OPP in diet (corresponding to approximately 40 mg/kg bw/d). In a 2-generation reproductive toxicity study (see section 3.3.8.1) performed in Sprague-Dawley rats, a NOAEL of 35 mg/kg bw/d was identified based on morphological ch","page":32,"pdf":"sccs_o_177.pdf","row_type":"noael_study","study_id":"sccs_o_177_noael_005"}
SCCS_vision_codex NOAEL =35 mg/kg bw/d rat oral 2-year reproductive toxicity {"citation":"(Ref. 303)","dose":"303), a NOAEL of 39 mg/kg bw/d was obtained based on urinary bladder hyperplasia and urinary bladder transitional cell carcinoma.","effect":"picture: In a 2-year bioassay in F344 rats (Ref. 303), a NOAEL of 39 mg/kg bw/d was obtained based on urinary bladder hyperplasia and urinary bladder transitional cell carcinoma. In a study investigating cytotoxicity and regenerative hyperplasia in male F344 rats fed different levels of OPP (Ref. 263), no effects were observed at a dose level of 0.08 % OPP in diet (corresponding to approximately 40 mg/kg bw/d). In a 2-generation reproductive toxicity study (see section 3.3.8.1) performed in Sprague-Dawley rats, a NOAEL of 35 mg/kg bw/d was identified based on morphological changes in the urinary bladder (Ref. 36). SCCS conclusions on chronic toxicity and carcinogenicity The urinary bladder and kidneys of rats are the main target tissues after chronic administration of OPP and SOPP. OPP and SOPP resulted in urinary bladder tumours (papilloma and carcinoma, mainly transitional cell papilloma and carcinoma) in male F344 rats. At higher doses, also the renal pelvis and the renal papilla are target tissues for OPP- and SOPP toxicity","page":32,"pdf":"sccs_o_177.pdf","row_type":"noael_study","study_id":"sccs_o_177_noael_006"}
SCCS_vision_codex NOAEL =457 mg/kg rat - - reproductive toxicity {"citation":"Ref.: 36 SCCS comment SCCS notes that based on deviations from the Guideline protocol, Kwock and Silva (2013) stated that assessments on fertility in that study were inconclusive","dose":"The incidence of calculi in the kidney and/or urinary bladder was increased in male P and F1 rats at 125 and 457 mg/kg.","effect":"and F1 adults. The incidence of calculi in the kidney and/or urinary bladder was increased in male P and F1 rats at 125 and 457 mg/kg. Transitional cell hyperplasia/papillomatosis in the urinary bladder was diagnosed in 457 mg/kg P males and females and in 457 mg/kg F1 males. Morphometry measurements confirmed the microscopic findings at 457 mg/kg and indicated a compound-related effect also in 125 mg/kg P males and females. No embryotoxic or teratogenic effects were observed at doses up to 457 mg/kg. The overall NOAEL for the adults, based on morphological changes, was considered as 35 mg/kg. Ref.: 36 SCCS comment SCCS notes that based on deviations from the Guideline protocol, Kwock and Silva (2013) stated that assessments on fertility in that study were inconclusive. Guideline: OECD TG 416 Species/strain: rat, CD Sprague-Dawley Group size: 30/sex/dose Test substance: OPP, technical grade Batch: S-01-93 (mixture of OPP from Dow and Bayer) Purity: 99.5 – 100 % Vehicle: / Dose levels: 0, 20, 100, 500 mg/kg bw/d Dose volume: /","page":33,"pdf":"sccs_o_177.pdf","row_type":"noael_study","study_id":"sccs_o_177_noael_007"}
SCCS_vision_codex NOAEL =500 mg/kg bw/d - - chronic reproductive toxicity {"citation":"Ref.:37, 38 SCCS comment Some important reprotoxic parameters (e","dose":", and an increased severity of background lesions in the kidneys, transitional cell hyperplasia (simple and/or nodular/papillary), calculi, and chronic inflammation in the urinary bladder as well as dilatation and hyperplasia of the ureter in P and F1 males at 500 mg/kg.","effect":", and an increased severity of background lesions in the kidneys, transitional cell hyperplasia (simple and/or nodular/papillary), calculi, and chronic inflammation in the urinary bladder as well as dilatation and hyperplasia of the ureter in P and F1 males at 500 mg/kg. There were no effects on adult reproductive parameters. Pup weights were lower at 500 mg/kg bw/d. No effects were seen on litter size, gender distribution, number of stillborn, viability, clinical signs or gross pathology of pups. The reproductive NOAEL in this study was considered to be 500 mg/kg bw/d. The parental and neonatal NOAEL was considered to be 100 mg/kg based on decreased body weights, decreased pup weights and morphologic lesions in kidneys, urinary bladder and urether at 500 mg/kg bw/d. Ref.:37, 38 SCCS comment Some important reprotoxic parameters (e.g. sperm parameters, yellow bodies, weight of some reproductive organs) were not assessed in this study. 3.3.8.2 Other data on fertility and reproduction toxicity / 3.3.8.3 Developmental Toxicity R","page":34,"pdf":"sccs_o_177.pdf","row_type":"noael_study","study_id":"sccs_o_177_noael_008"}
SCCS_vision_codex NOAEL =100 mg/kg rabbit - chronic reproductive toxicity {"citation":"Ref.:37, 38 SCCS comment Some important reprotoxic parameters (e","dose":"hyperplasia (simple and/or nodular/papillary), calculi, and chronic inflammation in the urinary bladder as well as dilatation and hyperplasia of the ureter in P and F1 males at 500 mg/kg.","effect":"hyperplasia (simple and/or nodular/papillary), calculi, and chronic inflammation in the urinary bladder as well as dilatation and hyperplasia of the ureter in P and F1 males at 500 mg/kg. There were no effects on adult reproductive parameters. Pup weights were lower at 500 mg/kg bw/d. No effects were seen on litter size, gender distribution, number of stillborn, viability, clinical signs or gross pathology of pups. The reproductive NOAEL in this study was considered to be 500 mg/kg bw/d. The parental and neonatal NOAEL was considered to be 100 mg/kg based on decreased body weights, decreased pup weights and morphologic lesions in kidneys, urinary bladder and urether at 500 mg/kg bw/d. Ref.:37, 38 SCCS comment Some important reprotoxic parameters (e.g. sperm parameters, yellow bodies, weight of some reproductive organs) were not assessed in this study. 3.3.8.2 Other data on fertility and reproduction toxicity / 3.3.8.3 Developmental Toxicity Rabbits Guideline: OECD TG 414 Species/strain: Female rabbit, White New Zealand Gro","page":34,"pdf":"sccs_o_177.pdf","row_type":"noael_study","study_id":"sccs_o_177_noael_009"}
SCCS_vision_codex NOAEL =100 mg/kg/d rat - developmental developmental toxicity {"citation":"Ref.: 319","dose":"11.1 – 66.7 %) were observed at 100 (77 %) and 250 (72 %) mg/kg/d.","effect":"nomalies or malformations (data not shown). The only developmental effect of OPP in rabbits was increased incidence of litters with resorptions. Kwock and Silva (2013) carefully re-examined all available data considering probable statistical pitfalls. They came to the conclusion that statistically significant increases in resorptions clearly exceeding the actual control group (33.3 %) and the mean of historical controls (36.2 %, range: 11.1 – 66.7 %) were observed at 100 (77 %) and 250 (72 %) mg/kg/d. The maternal NOAEL was set at 100 mg/kg/d and the developmental NOAEL was set at 25 mg/kg/d. A NOAEL of 25 mg/kg bw/d will be taken for MOS calculation. Ref.: 319; Kwock and Silva (2013) Rats In a study from the open literature, OPP (commercial grade biocide, 99.69 % purity) at dose levels of 0, 100, 300 and 700 mg/kg bw/d was investigated in pregnant Sprague- Dawley rats (24 – 26 dams/dose; 36 control animals) for embryotoxic and teratogenic effects. Dose levels were based on the results of a range-finding study. One dam died at","page":35,"pdf":"sccs_o_177.pdf","row_type":"noael_study","study_id":"sccs_o_177_noael_010"}
SCCS_vision_codex NOAEL =25 mg/kg/d rat - developmental developmental toxicity {"citation":"Ref.: 319","dose":"11.1 – 66.7 %) were observed at 100 (77 %) and 250 (72 %) mg/kg/d.","effect":"y developmental effect of OPP in rabbits was increased incidence of litters with resorptions. Kwock and Silva (2013) carefully re-examined all available data considering probable statistical pitfalls. They came to the conclusion that statistically significant increases in resorptions clearly exceeding the actual control group (33.3 %) and the mean of historical controls (36.2 %, range: 11.1 – 66.7 %) were observed at 100 (77 %) and 250 (72 %) mg/kg/d. The maternal NOAEL was set at 100 mg/kg/d and the developmental NOAEL was set at 25 mg/kg/d. A NOAEL of 25 mg/kg bw/d will be taken for MOS calculation. Ref.: 319; Kwock and Silva (2013) Rats In a study from the open literature, OPP (commercial grade biocide, 99.69 % purity) at dose levels of 0, 100, 300 and 700 mg/kg bw/d was investigated in pregnant Sprague- Dawley rats (24 – 26 dams/dose; 36 control animals) for embryotoxic and teratogenic effects. Dose levels were based on the results of a range-finding study. One dam died at 700 mg/kg bw/day due to dosing error but there were","page":35,"pdf":"sccs_o_177.pdf","row_type":"noael_study","study_id":"sccs_o_177_noael_011"}
SCCS_vision_codex NOAEL =100 mg/kg bw/d rat oral - NOAEL study {"citation":"Ref.: 129","dose":"hree skeletal anomalies were statistically significantly increased (~13-15 %) at 700 mg/kg/d (delayed ossification of sternebrae, pinpoint holes in the occipital or interparietal plates in the skull, and skull bone island).","effect":"hree skeletal anomalies were statistically significantly increased (~13-15 %) at 700 mg/kg/d (delayed ossification of sternebrae, pinpoint holes in the occipital or interparietal plates in the skull, and skull bone island). Kwock and Silva (2013) discuss, that pre-implantation losses, which were observed at the highest dose tested, might be instances of early resorptions due to the methodologies applied for evaluation of this effect. Based on the results of this study, 100 mg/kg bw/d should be regarded as maternal NOAEL (due to decreased body weight and food consumption at 300 mg/kg bw/d) and 300 mg/kg bw/d should be regarded as the foetal NOAEL. Ref.: 129; Kwock and Silva (2013) In a further study from the open literature (no information on guideline adherence or GLP), pregnant Wistar rats (18-20 dams/dose; 11 dams at the highest dose tested) were treated with OPP (99.7 % purity) by gavage at 0 (aqueous gum arabic), 150, 300, 600, or 1200 mg/kg bw/d on gestation days (GD) 6 through 15. The animals were sacrificed on GD 20. At","page":36,"pdf":"sccs_o_177.pdf","row_type":"noael_study","study_id":"sccs_o_177_noael_013"}
SCCS_vision_codex NOAEL =300 mg/kg bw/d rat oral 9 days NOAEL study {"citation":"Ref.: 129","dose":"Kwock and Silva (2013) discuss, that pre-implantation losses, which were observed at the highest dose tested, might be instances of early resorptions due to the methodologies applied for evaluation of this effect.","effect":", pinpoint holes in the occipital or interparietal plates in the skull, and skull bone island). Kwock and Silva (2013) discuss, that pre-implantation losses, which were observed at the highest dose tested, might be instances of early resorptions due to the methodologies applied for evaluation of this effect. Based on the results of this study, 100 mg/kg bw/d should be regarded as maternal NOAEL (due to decreased body weight and food consumption at 300 mg/kg bw/d) and 300 mg/kg bw/d should be regarded as the foetal NOAEL. Ref.: 129; Kwock and Silva (2013) In a further study from the open literature (no information on guideline adherence or GLP), pregnant Wistar rats (18-20 dams/dose; 11 dams at the highest dose tested) were treated with OPP (99.7 % purity) by gavage at 0 (aqueous gum arabic), 150, 300, 600, or 1200 mg/kg bw/d on gestation days (GD) 6 through 15. The animals were sacrificed on GD 20. At the highest dose tested, 10/11 dams died after 3-9 days of treatment. At 600 mg/kg bw/d, 2 of the 20 dams died. At ≥ 300 mg/kg b","page":36,"pdf":"sccs_o_177.pdf","row_type":"noael_study","study_id":"sccs_o_177_noael_014"}
SCCS_vision_codex NOAEL =150 mg/kg mouse - developmental developmental toxicity {"citation":"Ref.:133","dose":"At ≥ 300 mg/kg bw/d, pregnant animals fell into ataxia for several hours and there was a dose-related increase.","effect":"g/kg bw/d, 2 of the 20 dams died. At ≥ 300 mg/kg bw/d, pregnant animals fell into ataxia for several hours and there was a dose-related increase. At doses ≥ 300 mg/kg bw/d, dams had decreased body weight gains from GD 9. Effects to foetuses from OPP exposure in utero at the 600 mg/kg bw/d group appeared as an increased (p<0.01) incidence of resorptions and reduced foetal body weights (both sexes). From the results of the study it can be concluded that foetal effects occurred at maternally toxic doses. The maternal NOAEL can be set at 150 mg/kg be/d based on decreased body weight gain and occurrence of ataxia from 300 mg/kg bw/d. The foetal (developmental) NOAEL can be set at 600 mg/kg bw/d based on reduced foetal body weight and an increased incidence of resorptions. Ref.:133; Kwock and Silva (2013) Mice The developmental toxicity of OPP (from Tokyo Kasei Ltd., Lot FB 103) and SOPP (from Dow, Lot MM0144) has been investigated in mice. No information on guideline adherence or GLP is available. In the study with OPP, four groups","page":36,"pdf":"sccs_o_177.pdf","row_type":"noael_study","study_id":"sccs_o_177_noael_015"}
SCCS_vision_codex NOAEL =600 mg/kg bw/d mouse oral developmental developmental toxicity {"citation":"Ref.:133","dose":"At doses ≥ 300 mg/kg bw/d, dams had decreased body weight gains from GD 9.","effect":". At doses ≥ 300 mg/kg bw/d, dams had decreased body weight gains from GD 9. Effects to foetuses from OPP exposure in utero at the 600 mg/kg bw/d group appeared as an increased (p<0.01) incidence of resorptions and reduced foetal body weights (both sexes). From the results of the study it can be concluded that foetal effects occurred at maternally toxic doses. The maternal NOAEL can be set at 150 mg/kg be/d based on decreased body weight gain and occurrence of ataxia from 300 mg/kg bw/d. The foetal (developmental) NOAEL can be set at 600 mg/kg bw/d based on reduced foetal body weight and an increased incidence of resorptions. Ref.:133; Kwock and Silva (2013) Mice The developmental toxicity of OPP (from Tokyo Kasei Ltd., Lot FB 103) and SOPP (from Dow, Lot MM0144) has been investigated in mice. No information on guideline adherence or GLP is available. In the study with OPP, four groups of Jcl:ICR mice considered pregnant (21 animals/dose) received gavage dosages of 0, 1450, 1740, and 2100 mg/kg bw/d OPP in olive oil from GD 7 t","page":36,"pdf":"sccs_o_177.pdf","row_type":"noael_study","study_id":"sccs_o_177_noael_016"}
SCCS_vision_codex NOAEL =100 mg/kg bw rat - developmental reproductive toxicity {"dose":"No adverse effects of OPP on foetuses of rabbits were observed, however, there were increased incidences of resorptions independent from maternal toxicity, leading to a developmental NOAEL of 25 mg/kg bw/d.","effect":"n investigated in rabbits, rats and mice and there is a report on developmental toxicity of SOPP in mice. No adverse effects of OPP on foetuses of rabbits were observed, however, there were increased incidences of resorptions independent from maternal toxicity, leading to a developmental NOAEL of 25 mg/kg bw/d. An increased incidence of resorption was also reported from developmental toxicity studies performed with OPP in rats. The lowest maternal NOAEL of OPP identified in rats was 100 mg/kg bw whereas the lowest NOAEL for development identified in rats was 300 mg/kg bw/d. In mice treated with comparably high doses of OPP, maternal and developmental effects were observed at all concentrations tested and an LOAEL of 1450 mg/kg bw/d was identified. In mice treated with SOPP, developmental effects (reduced foetal weight and increased incidence of cleft palate) could be observed at the lowest dose tested (100 mg/kg bw/d). As a summary, whereas OPP does not adversely affect fertility or reproductive","page":37,"pdf":"sccs_o_177.pdf","row_type":"noael_study","study_id":"sccs_o_177_noael_019"}
SCCS_vision_codex NOAEL =25 mg/kg bw/d - - developmental developmental toxicity {"citation":"(ref. California Environmental Protection Agency, April 2007. Ortho-Phenylphenol (OPP)","dose":"The lowest developmental NOAEL identified was 25 mg/kg bw/d, which will be taken for MOS calculation.","effect":"SCCS/1555/15 Revision of the Opinion on o-Phenylphenol, Sodium o-phenylphenate and Potassium o-phenylphenate ____________________________________________________________________________________________________________________ 38 organs, increased incidence of resorptions can be considered as a developmental effect of OPP and SOPP. The lowest developmental NOAEL identified was 25 mg/kg bw/d, which will be taken for MOS calculation. 3.3.9 Toxicokinetics 3.3.9.1 Toxicokinetics in laboratory animals The toxicokinetics of OPP has been investigated in vitro and in vivo in different species. The principal metabolic pathways are given in figure 1. Figure 1: Overview on the metabolic pathways of OPP in different mammalian species (ref. California Environmental Protection Agency, April 2007. Ortho-Phenylphenol (OPP) and Sodium Ortho-Phenylphenate (SOPP), Risk Characteriza","page":38,"pdf":"sccs_o_177.pdf","row_type":"noael_study","study_id":"sccs_o_177_noael_020"}
SCCS_vision_codex NOAEL =100 % rabbit oral developmental developmental toxicity {"dose":"Absorption through the skin DAp (%) = 45 % Amount of cosmetic product applied daily A (g/d) = 17.4 g/d Concentration of ingredient in finished product C (%) = 0.2 % Typical body weight of human = 60 kg Systemic exposure dose (SED) = A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60 = 0.261 mg/kg bw/d No adverse observed effect level NOAEL = 25 m...","effect":"MoS calculation according to the SCCS's Notes of Guidance 8th revision. Absorption through the skin DAp (%) = 45 % Amount of cosmetic product applied daily A (g/d) = 17.4 g/d Concentration of ingredient in finished product C (%) = 0.2 % Typical body weight of human = 60 kg Systemic exposure dose (SED) = A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60 = 0.261 mg/kg bw/d No adverse observed effect level NOAEL = 25 mg/kg bw/d (oral developmental toxicity study, rabbit) No adjustment, 100 % oral absorption MOS NOAEL/SED = 96 2. Rinse-off products An aggregate value of 0.54 g/d (8.3 mg/kg bw/d) for the amount of cosmetics applied daily is taken for MoS calculation, according to the SCCS's Notes of Guidance 8th revision. Absorption through the skin DAp (%) = 45 % Amount of cosmetic product applied daily A (g/d) = 0.54 g/d Concentration of ingredient in finished product C (%) = 0.2 % Typical body weight of human = 60 kg Systemic exposure dose (SED) = A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60 = 0.0081 mg/kg bw/d No","page":47,"pdf":"sccs_o_177.pdf","row_type":"noael_study","study_id":"sccs_o_177_noael_025"}
SCCS_vision_codex NOAEL =4 % rat oral - NOAEL study {"dose":"352, 694, 1338, and 2431 mg/kg bw/day for females papillomas plus 5 transitional cell carcinomas at 2% and 1 transitional cell carcinoma at 4%, as opposed to only 2 papillomas at 4% in females.","effect":"352, 694, 1338, and 2431 mg/kg bw/day for females papillomas plus 5 transitional cell carcinomas at 2% and 1 transitional cell carcinoma at 4%, as opposed to only 2 papillomas at 4% in females. No bladder calculi were observed. Moderate pyelonephritis was recorded in 6/10 males and slight in 1/10 females at 4%. No tumours at sites other than the urinary system were found. Liver: increases in liver weight; changes in liver enzymes. Kidneys: pyelonephritis in high dose males and females; increase in kidney weights. NOAEL. In 4 % males: pyelonephritis as predominating effect (60%; p≤0.01); in 2% males: neoplastic lesions in bladder as predominating effect (transitional cell papilloma, 44% (p≤0.05); transitional cell carcinoma 56% (p≤0.01). Purity SOPP > 95% Unclear (Text body in Japanese) male F344 rats (n=20/group) Dietary administration of 0, 0.625, 1.25, or 2.5% Body weight gain dose-dependently decreased at 1.25 and 2.5%. No changes were noted in biochemical investigations of plasma samples. Red blood cell count and the amoun","page":80,"pdf":"sccs_o_177.pdf","row_type":"noael_study","study_id":"sccs_o_177_noael_032"}
SCCS_vision_codex NOAEL =2.5 % rat oral - NOAEL study {"dose":"Unclear (Text body in Japanese) | male F344 rats (n=20/group) Dietary administration of 0, 0.625, 1.25, or 2.5% | Body weight gain dose-dependently decreased at 1.25 and 2.5%.","effect":"Unlabeled table on page 80: Unclear (Text body in Japanese) | male F344 rats (n=20/group) Dietary administration of 0, 0.625, 1.25, or 2.5% | Body weight gain dose-dependently decreased at 1.25 and 2.5%. No changes were noted in biochemical investigations of plasma samples. Red blood cell count and the amount of haemoglobin were decreased at 2.5%. The relative weight of the urinary bladder was dose-dependently increased (nearly by about 50% at the highest concentration). The | Decrease of urinary pH observed; acidification could be due to nephritis; supporting study. Publication in Japanese, only tables and numbers | 190","page":80,"pdf":"sccs_o_177.pdf","row_type":"noael_study","study_id":"sccs_o_177_noael_034"}
SCCS_vision_codex NOAEL >98 % rat oral 24 months NOAEL study {"citation":"Ref.: 106 SCCS comment Due to poor reporting the study cannot be used to derive a NOAEL","dose":"Decreased (p<0.01) body weights occurred in males (10 %) and females (6 %) at 20000 ppm.","effect":"SCCS-rejected applicant NOAEL: rol groups, only 22-32 % of the animals were alive at the end of 24 months. Decreased (p<0.01) body weights occurred in males (10 %) and females (6 %) at 20000 ppm. Another effect observed at the highest dose level was increased relative testis weight (46 %). Extensive renal damage characterised by marked tubular dilation with varying degrees of acute and chronic inflammation was found in male and female animals at the highest dose. Ref.: 106 SCCS comment Due to poor reporting the study cannot be used to derive a NOAEL. In a study from the open literature, Dowicide 1 (Lot MM01040, purity > 98 %) was administered for 91 weeks to male F344/DuCrj rats at dietary concentrations of 0, 0.625, 1.25 and 2.5 % corresponding to 0, 269, 531 and 1140 mg/kg bw/d. Survival was 100 %, 71 % (p < 0.05) and 65 % (p < 0.05) at 269, 531 and 1140 mg/kg bw/d, respectively. The following findings were observed in treated animals: increased (20 %) white blood cell count at the highest dose, hematuria at 531 and 1140 mg/kg bw/d, increased water intake","page":24,"pdf":"sccs_o_177.pdf","row_type":"noael_study","study_id":"sccs_o_177_noael_001"}
SCCS_vision_codex NOAEL =92 mg/kg/day mouse - - NOAEL study {"citation":"Ref.: 165, 166 SCCS conclusion Apparently the study was not performed according to an accepted guideline","dose":"ion to the increased incidence, the lesion severity (e.g., tubular epithelium degeneration) also appeared to increase with dose.","effect":"ion to the increased incidence, the lesion severity (e.g., tubular epithelium degeneration) also appeared to increase with dose. Reduced (p<0.05) absolute kidney weights occurred in each of the OPP-treated groups (7-24 %), but the dose-response seemed consistent with the general body weight reductions noted in these groups (12-43 %). Based on the induction of renal tubular epithelium degeneration, spleen atrophy, increased water intake, and increased relative liver weight, occurring at each concentration tested, a NOAEL cannot be derived. 92 mg/kg/day can be considered as LOAEL. Ref.: 165, 166 SCCS conclusion Apparently the study was not performed according to an accepted guideline. Only male animals were used in the study. The study can be used as supporting information about OPP target tissues in mice. Tumour incidences in the liver did not represent a dose response. Types of liver cancers were not reported. Guideline: OECD TG 453 Species/strain: mouse, B6C3F1 Group size: 50/sex/dose (main group) 10/sex/dose (satellite grou","page":25,"pdf":"sccs_o_177.pdf","row_type":"noael_study","study_id":"sccs_o_177_noael_002"}
SCCS_vision_codex NOAEL =250 mg/kg bw/d mouse oral 5d NOAEL study {"citation":"Ref.: 220, 221 In a GLP-compliant study four groups of beagle dogs (4 animals/sex/dose) received OPP (purity 99","dose":"ignificantly increased in livers of male mice, however, a statistically significant increase in hepatocellular adenoma was observed at the two highest doses (27/50 in controls, 33/50 at 250 mg/kg, 40/50 at 500 mg/kg, and 41/50 at 1000 mg/kg).","effect":"ignificantly increased in livers of male mice, however, a statistically significant increase in hepatocellular adenoma was observed at the two highest doses (27/50 in controls, 33/50 at 250 mg/kg, 40/50 at 500 mg/kg, and 41/50 at 1000 mg/kg). In female mice, also microscopic changes in livers were seen, however, no female mouse had a hepatoblastoma and there were no statistically significant increases in liver or other tumours in the female animals. As treatment-related effects were observed in all dose groups, no NOAEL can be derived from this study. The LOAEL is considered to be 250 mg/kg bw/d. SCCS comment In this study in mice, the heart was not identified as a target organ. CalEpa considered the incidence of hepatoblastoma at the mid dose as treatment-related due to its rare spontaneous occurrence in this strain. Ref.: 220, 221 In a GLP-compliant study four groups of beagle dogs (4 animals/sex/dose) received OPP (purity 99.77 %, identification #8800005-24) at gavage doses of 0, 30, 100, or 300 mg/kg bw/d, 5d / week, for","page":26,"pdf":"sccs_o_177.pdf","row_type":"noael_study","study_id":"sccs_o_177_noael_003"}
SCCS_vision_codex NOAEL >300 mg/kg/day mouse oral 5d NOAEL study {"citation":"Ref.: 220, 221 In a GLP-compliant study four groups of beagle dogs (4 animals/sex/dose) received OPP (purity 99","dose":"incidence of hepatoblastoma at the mid dose as treatment-related due to its rare spontaneous occurrence in this strain.","effect":"incidence of hepatoblastoma at the mid dose as treatment-related due to its rare spontaneous occurrence in this strain. Ref.: 220, 221 In a GLP-compliant study four groups of beagle dogs (4 animals/sex/dose) received OPP (purity 99.77 %, identification #8800005-24) at gavage doses of 0, 30, 100, or 300 mg/kg bw/d, 5d / week, for one year. There were no effects on body weight, feed consumption, ophthalmology, haematology, urinalysis, and pathology. The only clinical sign was vomiting (dose-dependent increase). A NOAEL > 300 mg/kg/day can be derived from this study. Ref.: 32 Dermal mouse Swiss CD-1 mice (50/sex) received repeated dermal applications of 55 mg OPP (99 % purity, lot MM09157), dissolved in 0.1 ml acetone solution for 102 weeks. Treatment did not affect survival and body weight. No skin neoplasms occurred in mice dosed with OPP, however non-neoplastic lesions (ulcer, active chronic inflammation, hyperkeratosis and acanthosis) were observed at the application site. Systemically, slightly increased incidences of di","page":26,"pdf":"sccs_o_177.pdf","row_type":"noael_study","study_id":"sccs_o_177_noael_004"}
SCCS_vision_codex NOAEL =39 mg/kg bw/d rat oral 2-year reproductive toxicity {"citation":"(Ref. 303)","dose":"303), a NOAEL of 39 mg/kg bw/d was obtained based on urinary bladder hyperplasia and urinary bladder transitional cell carcinoma.","effect":"OPP) • Species- and strain-specific differences (OPP-induced bladder tumours were not observed in female rats, mice, dogs) • dermal application to mice does not affect tumour incidence in skin • no skin tumour development induced by OPP metabolites • tumours occur at high doses when sulfate and glucuronide conjugation pathways are saturated The threshold for OPP-induced bladder tumours can be approached from different studies all yielding a quite consistent picture: In a 2-year bioassay in F344 rats (Ref. 303), a NOAEL of 39 mg/kg bw/d was obtained based on urinary bladder hyperplasia and urinary bladder transitional cell carcinoma. In a study investigating cytotoxicity and regenerative hyperplasia in male F344 rats fed different levels of OPP (Ref. 263), no effects were observed at a dose level of 0.08 % OPP in diet (corresponding to approximately 40 mg/kg bw/d). In a 2-generation reproductive toxicity study (see section 3.3.8.1) performed in Sprague-Dawley rats, a NOAEL of 35 mg/kg bw/d was identified based on morphological ch","page":32,"pdf":"sccs_o_177.pdf","row_type":"noael_study","study_id":"sccs_o_177_noael_005"}
SCCS_vision_codex NOAEL =35 mg/kg bw/d rat oral 2-year reproductive toxicity {"citation":"(Ref. 303)","dose":"303), a NOAEL of 39 mg/kg bw/d was obtained based on urinary bladder hyperplasia and urinary bladder transitional cell carcinoma.","effect":"picture: In a 2-year bioassay in F344 rats (Ref. 303), a NOAEL of 39 mg/kg bw/d was obtained based on urinary bladder hyperplasia and urinary bladder transitional cell carcinoma. In a study investigating cytotoxicity and regenerative hyperplasia in male F344 rats fed different levels of OPP (Ref. 263), no effects were observed at a dose level of 0.08 % OPP in diet (corresponding to approximately 40 mg/kg bw/d). In a 2-generation reproductive toxicity study (see section 3.3.8.1) performed in Sprague-Dawley rats, a NOAEL of 35 mg/kg bw/d was identified based on morphological changes in the urinary bladder (Ref. 36). SCCS conclusions on chronic toxicity and carcinogenicity The urinary bladder and kidneys of rats are the main target tissues after chronic administration of OPP and SOPP. OPP and SOPP resulted in urinary bladder tumours (papilloma and carcinoma, mainly transitional cell papilloma and carcinoma) in male F344 rats. At higher doses, also the renal pelvis and the renal papilla are target tissues for OPP- and SOPP toxicity","page":32,"pdf":"sccs_o_177.pdf","row_type":"noael_study","study_id":"sccs_o_177_noael_006"}
SCCS_vision_codex NOAEL =457 mg/kg rat - - reproductive toxicity {"citation":"Ref.: 36 SCCS comment SCCS notes that based on deviations from the Guideline protocol, Kwock and Silva (2013) stated that assessments on fertility in that study were inconclusive","dose":"The incidence of calculi in the kidney and/or urinary bladder was increased in male P and F1 rats at 125 and 457 mg/kg.","effect":"and F1 adults. The incidence of calculi in the kidney and/or urinary bladder was increased in male P and F1 rats at 125 and 457 mg/kg. Transitional cell hyperplasia/papillomatosis in the urinary bladder was diagnosed in 457 mg/kg P males and females and in 457 mg/kg F1 males. Morphometry measurements confirmed the microscopic findings at 457 mg/kg and indicated a compound-related effect also in 125 mg/kg P males and females. No embryotoxic or teratogenic effects were observed at doses up to 457 mg/kg. The overall NOAEL for the adults, based on morphological changes, was considered as 35 mg/kg. Ref.: 36 SCCS comment SCCS notes that based on deviations from the Guideline protocol, Kwock and Silva (2013) stated that assessments on fertility in that study were inconclusive. Guideline: OECD TG 416 Species/strain: rat, CD Sprague-Dawley Group size: 30/sex/dose Test substance: OPP, technical grade Batch: S-01-93 (mixture of OPP from Dow and Bayer) Purity: 99.5 – 100 % Vehicle: / Dose levels: 0, 20, 100, 500 mg/kg bw/d Dose volume: /","page":33,"pdf":"sccs_o_177.pdf","row_type":"noael_study","study_id":"sccs_o_177_noael_007"}
SCCS_vision_codex NOAEL =500 mg/kg bw/d - - chronic reproductive toxicity {"citation":"Ref.:37, 38 SCCS comment Some important reprotoxic parameters (e","dose":", and an increased severity of background lesions in the kidneys, transitional cell hyperplasia (simple and/or nodular/papillary), calculi, and chronic inflammation in the urinary bladder as well as dilatation and hyperplasia of the ureter in P and F1 males at 500 mg/kg.","effect":", and an increased severity of background lesions in the kidneys, transitional cell hyperplasia (simple and/or nodular/papillary), calculi, and chronic inflammation in the urinary bladder as well as dilatation and hyperplasia of the ureter in P and F1 males at 500 mg/kg. There were no effects on adult reproductive parameters. Pup weights were lower at 500 mg/kg bw/d. No effects were seen on litter size, gender distribution, number of stillborn, viability, clinical signs or gross pathology of pups. The reproductive NOAEL in this study was considered to be 500 mg/kg bw/d. The parental and neonatal NOAEL was considered to be 100 mg/kg based on decreased body weights, decreased pup weights and morphologic lesions in kidneys, urinary bladder and urether at 500 mg/kg bw/d. Ref.:37, 38 SCCS comment Some important reprotoxic parameters (e.g. sperm parameters, yellow bodies, weight of some reproductive organs) were not assessed in this study. 3.3.8.2 Other data on fertility and reproduction toxicity / 3.3.8.3 Developmental Toxicity R","page":34,"pdf":"sccs_o_177.pdf","row_type":"noael_study","study_id":"sccs_o_177_noael_008"}
SCCS_vision_codex NOAEL =100 mg/kg rabbit - chronic reproductive toxicity {"citation":"Ref.:37, 38 SCCS comment Some important reprotoxic parameters (e","dose":"hyperplasia (simple and/or nodular/papillary), calculi, and chronic inflammation in the urinary bladder as well as dilatation and hyperplasia of the ureter in P and F1 males at 500 mg/kg.","effect":"hyperplasia (simple and/or nodular/papillary), calculi, and chronic inflammation in the urinary bladder as well as dilatation and hyperplasia of the ureter in P and F1 males at 500 mg/kg. There were no effects on adult reproductive parameters. Pup weights were lower at 500 mg/kg bw/d. No effects were seen on litter size, gender distribution, number of stillborn, viability, clinical signs or gross pathology of pups. The reproductive NOAEL in this study was considered to be 500 mg/kg bw/d. The parental and neonatal NOAEL was considered to be 100 mg/kg based on decreased body weights, decreased pup weights and morphologic lesions in kidneys, urinary bladder and urether at 500 mg/kg bw/d. Ref.:37, 38 SCCS comment Some important reprotoxic parameters (e.g. sperm parameters, yellow bodies, weight of some reproductive organs) were not assessed in this study. 3.3.8.2 Other data on fertility and reproduction toxicity / 3.3.8.3 Developmental Toxicity Rabbits Guideline: OECD TG 414 Species/strain: Female rabbit, White New Zealand Gro","page":34,"pdf":"sccs_o_177.pdf","row_type":"noael_study","study_id":"sccs_o_177_noael_009"}
SCCS_vision_codex NOAEL =100 mg/kg/d rat - developmental developmental toxicity {"citation":"Ref.: 319","dose":"11.1 – 66.7 %) were observed at 100 (77 %) and 250 (72 %) mg/kg/d.","effect":"nomalies or malformations (data not shown). The only developmental effect of OPP in rabbits was increased incidence of litters with resorptions. Kwock and Silva (2013) carefully re-examined all available data considering probable statistical pitfalls. They came to the conclusion that statistically significant increases in resorptions clearly exceeding the actual control group (33.3 %) and the mean of historical controls (36.2 %, range: 11.1 – 66.7 %) were observed at 100 (77 %) and 250 (72 %) mg/kg/d. The maternal NOAEL was set at 100 mg/kg/d and the developmental NOAEL was set at 25 mg/kg/d. A NOAEL of 25 mg/kg bw/d will be taken for MOS calculation. Ref.: 319; Kwock and Silva (2013) Rats In a study from the open literature, OPP (commercial grade biocide, 99.69 % purity) at dose levels of 0, 100, 300 and 700 mg/kg bw/d was investigated in pregnant Sprague- Dawley rats (24 – 26 dams/dose; 36 control animals) for embryotoxic and teratogenic effects. Dose levels were based on the results of a range-finding study. One dam died at","page":35,"pdf":"sccs_o_177.pdf","row_type":"noael_study","study_id":"sccs_o_177_noael_010"}
SCCS_vision_codex NOAEL =25 mg/kg/d rat - developmental developmental toxicity {"citation":"Ref.: 319","dose":"11.1 – 66.7 %) were observed at 100 (77 %) and 250 (72 %) mg/kg/d.","effect":"y developmental effect of OPP in rabbits was increased incidence of litters with resorptions. Kwock and Silva (2013) carefully re-examined all available data considering probable statistical pitfalls. They came to the conclusion that statistically significant increases in resorptions clearly exceeding the actual control group (33.3 %) and the mean of historical controls (36.2 %, range: 11.1 – 66.7 %) were observed at 100 (77 %) and 250 (72 %) mg/kg/d. The maternal NOAEL was set at 100 mg/kg/d and the developmental NOAEL was set at 25 mg/kg/d. A NOAEL of 25 mg/kg bw/d will be taken for MOS calculation. Ref.: 319; Kwock and Silva (2013) Rats In a study from the open literature, OPP (commercial grade biocide, 99.69 % purity) at dose levels of 0, 100, 300 and 700 mg/kg bw/d was investigated in pregnant Sprague- Dawley rats (24 – 26 dams/dose; 36 control animals) for embryotoxic and teratogenic effects. Dose levels were based on the results of a range-finding study. One dam died at 700 mg/kg bw/day due to dosing error but there were","page":35,"pdf":"sccs_o_177.pdf","row_type":"noael_study","study_id":"sccs_o_177_noael_011"}
SCCS_vision_codex NOAEL =100 mg/kg bw/d rat oral - NOAEL study {"citation":"Ref.: 129","dose":"hree skeletal anomalies were statistically significantly increased (~13-15 %) at 700 mg/kg/d (delayed ossification of sternebrae, pinpoint holes in the occipital or interparietal plates in the skull, and skull bone island).","effect":"hree skeletal anomalies were statistically significantly increased (~13-15 %) at 700 mg/kg/d (delayed ossification of sternebrae, pinpoint holes in the occipital or interparietal plates in the skull, and skull bone island). Kwock and Silva (2013) discuss, that pre-implantation losses, which were observed at the highest dose tested, might be instances of early resorptions due to the methodologies applied for evaluation of this effect. Based on the results of this study, 100 mg/kg bw/d should be regarded as maternal NOAEL (due to decreased body weight and food consumption at 300 mg/kg bw/d) and 300 mg/kg bw/d should be regarded as the foetal NOAEL. Ref.: 129; Kwock and Silva (2013) In a further study from the open literature (no information on guideline adherence or GLP), pregnant Wistar rats (18-20 dams/dose; 11 dams at the highest dose tested) were treated with OPP (99.7 % purity) by gavage at 0 (aqueous gum arabic), 150, 300, 600, or 1200 mg/kg bw/d on gestation days (GD) 6 through 15. The animals were sacrificed on GD 20. At","page":36,"pdf":"sccs_o_177.pdf","row_type":"noael_study","study_id":"sccs_o_177_noael_013"}
SCCS_vision_codex NOAEL =300 mg/kg bw/d rat oral 9 days NOAEL study {"citation":"Ref.: 129","dose":"Kwock and Silva (2013) discuss, that pre-implantation losses, which were observed at the highest dose tested, might be instances of early resorptions due to the methodologies applied for evaluation of this effect.","effect":", pinpoint holes in the occipital or interparietal plates in the skull, and skull bone island). Kwock and Silva (2013) discuss, that pre-implantation losses, which were observed at the highest dose tested, might be instances of early resorptions due to the methodologies applied for evaluation of this effect. Based on the results of this study, 100 mg/kg bw/d should be regarded as maternal NOAEL (due to decreased body weight and food consumption at 300 mg/kg bw/d) and 300 mg/kg bw/d should be regarded as the foetal NOAEL. Ref.: 129; Kwock and Silva (2013) In a further study from the open literature (no information on guideline adherence or GLP), pregnant Wistar rats (18-20 dams/dose; 11 dams at the highest dose tested) were treated with OPP (99.7 % purity) by gavage at 0 (aqueous gum arabic), 150, 300, 600, or 1200 mg/kg bw/d on gestation days (GD) 6 through 15. The animals were sacrificed on GD 20. At the highest dose tested, 10/11 dams died after 3-9 days of treatment. At 600 mg/kg bw/d, 2 of the 20 dams died. At ≥ 300 mg/kg b","page":36,"pdf":"sccs_o_177.pdf","row_type":"noael_study","study_id":"sccs_o_177_noael_014"}
SCCS_vision_codex NOAEL =150 mg/kg mouse - developmental developmental toxicity {"citation":"Ref.:133","dose":"At ≥ 300 mg/kg bw/d, pregnant animals fell into ataxia for several hours and there was a dose-related increase.","effect":"g/kg bw/d, 2 of the 20 dams died. At ≥ 300 mg/kg bw/d, pregnant animals fell into ataxia for several hours and there was a dose-related increase. At doses ≥ 300 mg/kg bw/d, dams had decreased body weight gains from GD 9. Effects to foetuses from OPP exposure in utero at the 600 mg/kg bw/d group appeared as an increased (p<0.01) incidence of resorptions and reduced foetal body weights (both sexes). From the results of the study it can be concluded that foetal effects occurred at maternally toxic doses. The maternal NOAEL can be set at 150 mg/kg be/d based on decreased body weight gain and occurrence of ataxia from 300 mg/kg bw/d. The foetal (developmental) NOAEL can be set at 600 mg/kg bw/d based on reduced foetal body weight and an increased incidence of resorptions. Ref.:133; Kwock and Silva (2013) Mice The developmental toxicity of OPP (from Tokyo Kasei Ltd., Lot FB 103) and SOPP (from Dow, Lot MM0144) has been investigated in mice. No information on guideline adherence or GLP is available. In the study with OPP, four groups","page":36,"pdf":"sccs_o_177.pdf","row_type":"noael_study","study_id":"sccs_o_177_noael_015"}
SCCS_vision_codex NOAEL =600 mg/kg bw/d mouse oral developmental developmental toxicity {"citation":"Ref.:133","dose":"At doses ≥ 300 mg/kg bw/d, dams had decreased body weight gains from GD 9.","effect":". At doses ≥ 300 mg/kg bw/d, dams had decreased body weight gains from GD 9. Effects to foetuses from OPP exposure in utero at the 600 mg/kg bw/d group appeared as an increased (p<0.01) incidence of resorptions and reduced foetal body weights (both sexes). From the results of the study it can be concluded that foetal effects occurred at maternally toxic doses. The maternal NOAEL can be set at 150 mg/kg be/d based on decreased body weight gain and occurrence of ataxia from 300 mg/kg bw/d. The foetal (developmental) NOAEL can be set at 600 mg/kg bw/d based on reduced foetal body weight and an increased incidence of resorptions. Ref.:133; Kwock and Silva (2013) Mice The developmental toxicity of OPP (from Tokyo Kasei Ltd., Lot FB 103) and SOPP (from Dow, Lot MM0144) has been investigated in mice. No information on guideline adherence or GLP is available. In the study with OPP, four groups of Jcl:ICR mice considered pregnant (21 animals/dose) received gavage dosages of 0, 1450, 1740, and 2100 mg/kg bw/d OPP in olive oil from GD 7 t","page":36,"pdf":"sccs_o_177.pdf","row_type":"noael_study","study_id":"sccs_o_177_noael_016"}
SCCS_vision_codex NOAEL =100 mg/kg bw rat - developmental reproductive toxicity {"dose":"No adverse effects of OPP on foetuses of rabbits were observed, however, there were increased incidences of resorptions independent from maternal toxicity, leading to a developmental NOAEL of 25 mg/kg bw/d.","effect":"n investigated in rabbits, rats and mice and there is a report on developmental toxicity of SOPP in mice. No adverse effects of OPP on foetuses of rabbits were observed, however, there were increased incidences of resorptions independent from maternal toxicity, leading to a developmental NOAEL of 25 mg/kg bw/d. An increased incidence of resorption was also reported from developmental toxicity studies performed with OPP in rats. The lowest maternal NOAEL of OPP identified in rats was 100 mg/kg bw whereas the lowest NOAEL for development identified in rats was 300 mg/kg bw/d. In mice treated with comparably high doses of OPP, maternal and developmental effects were observed at all concentrations tested and an LOAEL of 1450 mg/kg bw/d was identified. In mice treated with SOPP, developmental effects (reduced foetal weight and increased incidence of cleft palate) could be observed at the lowest dose tested (100 mg/kg bw/d). As a summary, whereas OPP does not adversely affect fertility or reproductive","page":37,"pdf":"sccs_o_177.pdf","row_type":"noael_study","study_id":"sccs_o_177_noael_019"}
SCCS_vision_codex NOAEL =25 mg/kg bw/d - - developmental developmental toxicity {"citation":"(ref. California Environmental Protection Agency, April 2007. Ortho-Phenylphenol (OPP)","dose":"The lowest developmental NOAEL identified was 25 mg/kg bw/d, which will be taken for MOS calculation.","effect":"SCCS/1555/15 Revision of the Opinion on o-Phenylphenol, Sodium o-phenylphenate and Potassium o-phenylphenate ____________________________________________________________________________________________________________________ 38 organs, increased incidence of resorptions can be considered as a developmental effect of OPP and SOPP. The lowest developmental NOAEL identified was 25 mg/kg bw/d, which will be taken for MOS calculation. 3.3.9 Toxicokinetics 3.3.9.1 Toxicokinetics in laboratory animals The toxicokinetics of OPP has been investigated in vitro and in vivo in different species. The principal metabolic pathways are given in figure 1. Figure 1: Overview on the metabolic pathways of OPP in different mammalian species (ref. California Environmental Protection Agency, April 2007. Ortho-Phenylphenol (OPP) and Sodium Ortho-Phenylphenate (SOPP), Risk Characteriza","page":38,"pdf":"sccs_o_177.pdf","row_type":"noael_study","study_id":"sccs_o_177_noael_020"}
SCCS_vision_codex NOAEL =100 % rabbit oral developmental developmental toxicity {"dose":"Absorption through the skin DAp (%) = 45 % Amount of cosmetic product applied daily A (g/d) = 17.4 g/d Concentration of ingredient in finished product C (%) = 0.2 % Typical body weight of human = 60 kg Systemic exposure dose (SED) = A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60 = 0.261 mg/kg bw/d No adverse observed effect level NOAEL = 25 m...","effect":"MoS calculation according to the SCCS's Notes of Guidance 8th revision. Absorption through the skin DAp (%) = 45 % Amount of cosmetic product applied daily A (g/d) = 17.4 g/d Concentration of ingredient in finished product C (%) = 0.2 % Typical body weight of human = 60 kg Systemic exposure dose (SED) = A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60 = 0.261 mg/kg bw/d No adverse observed effect level NOAEL = 25 mg/kg bw/d (oral developmental toxicity study, rabbit) No adjustment, 100 % oral absorption MOS NOAEL/SED = 96 2. Rinse-off products An aggregate value of 0.54 g/d (8.3 mg/kg bw/d) for the amount of cosmetics applied daily is taken for MoS calculation, according to the SCCS's Notes of Guidance 8th revision. Absorption through the skin DAp (%) = 45 % Amount of cosmetic product applied daily A (g/d) = 0.54 g/d Concentration of ingredient in finished product C (%) = 0.2 % Typical body weight of human = 60 kg Systemic exposure dose (SED) = A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60 = 0.0081 mg/kg bw/d No","page":47,"pdf":"sccs_o_177.pdf","row_type":"noael_study","study_id":"sccs_o_177_noael_025"}
SCCS_vision_codex NOAEL =4 % rat oral - NOAEL study {"dose":"352, 694, 1338, and 2431 mg/kg bw/day for females papillomas plus 5 transitional cell carcinomas at 2% and 1 transitional cell carcinoma at 4%, as opposed to only 2 papillomas at 4% in females.","effect":"352, 694, 1338, and 2431 mg/kg bw/day for females papillomas plus 5 transitional cell carcinomas at 2% and 1 transitional cell carcinoma at 4%, as opposed to only 2 papillomas at 4% in females. No bladder calculi were observed. Moderate pyelonephritis was recorded in 6/10 males and slight in 1/10 females at 4%. No tumours at sites other than the urinary system were found. Liver: increases in liver weight; changes in liver enzymes. Kidneys: pyelonephritis in high dose males and females; increase in kidney weights. NOAEL. In 4 % males: pyelonephritis as predominating effect (60%; p≤0.01); in 2% males: neoplastic lesions in bladder as predominating effect (transitional cell papilloma, 44% (p≤0.05); transitional cell carcinoma 56% (p≤0.01). Purity SOPP > 95% Unclear (Text body in Japanese) male F344 rats (n=20/group) Dietary administration of 0, 0.625, 1.25, or 2.5% Body weight gain dose-dependently decreased at 1.25 and 2.5%. No changes were noted in biochemical investigations of plasma samples. Red blood cell count and the amoun","page":80,"pdf":"sccs_o_177.pdf","row_type":"noael_study","study_id":"sccs_o_177_noael_032"}
SCCS_vision_codex NOAEL =2.5 % rat oral - NOAEL study {"dose":"Unclear (Text body in Japanese) | male F344 rats (n=20/group) Dietary administration of 0, 0.625, 1.25, or 2.5% | Body weight gain dose-dependently decreased at 1.25 and 2.5%.","effect":"Unlabeled table on page 80: Unclear (Text body in Japanese) | male F344 rats (n=20/group) Dietary administration of 0, 0.625, 1.25, or 2.5% | Body weight gain dose-dependently decreased at 1.25 and 2.5%. No changes were noted in biochemical investigations of plasma samples. Red blood cell count and the amount of haemoglobin were decreased at 2.5%. The relative weight of the urinary bladder was dose-dependently increased (nearly by about 50% at the highest concentration). The | Decrease of urinary pH observed; acidification could be due to nephritis; supporting study. Publication in Japanese, only tables and numbers | 190","page":80,"pdf":"sccs_o_177.pdf","row_type":"noael_study","study_id":"sccs_o_177_noael_034"}
SCCS_vision_codex NOAEL =25 mg/kg bw/day rat - developmental developmental toxicity {"dose":"As a result, the LOAEL was established at 1450 mg/kg bw/day.","effect":"l effects were observed at all tested doses. As a result, the LOAEL was established at 1450 mg/kg bw/day. Similarly, an increased incidence of resorptions was reported in rat developmental toxicity studies with OPP. The lowest NOAELs identified for maternal and developmental effects were 100 and 300 mg/kg bw/day, respectively. In rabbits, no adverse effects on foetuses were observed. However, increased incidences of resorptions were noted, and these appeared to be independent of maternal toxicity. As a result, the NOAEL for developmental toxicity was established at 25 mg/kg bw/day. In the mouse study with SOPP, developmental effects, such as reduced foetal weight and an increased incidence of cleft palate, were observed even at the lowest dose tested (100 mg/kg bw/day). The only developmental toxicity study with SOPP, is not considered to be useful in safety assessment due to design and reporting limitations. However, it did suggest SOPP's potential interference with rodent development. In summary, while OPP did not adversely aff","page":31,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_001"}
SCCS_vision_codex NOAEL =25 mg/kg/d rabbit oral developmental reproductive toxicity {"dose":"In summary, while OPP did not adversely affect fertility or reproductive organs, the increased incidence of resorptions can be considered a developmental effect of both OPP and SOPP with a critical NOAEL of 25 mg/kg bw/day.","effect":"potential interference with rodent development. In summary, while OPP did not adversely affect fertility or reproductive organs, the increased incidence of resorptions can be considered a developmental effect of both OPP and SOPP with a critical NOAEL of 25 mg/kg bw/day. SCCS comment on developmental toxicity In SCCS/1555/15, the SCCS derived a NOAEL of 25 mg/kg/d based on a re-analysis by Kwock and Silva (2013) of data from a teratology study performed in New Zealand White Rabbits (Zablotny et al., 1991b). This NOAEL is lower than other PoDs obtained from other repeat- dose/long-term toxicity studies performed with OPP and SOPP. Therefore, this conservative value of 25 mg/kg bw/d is taken for MoS calculation for both, OPP and SOPP. 3.4.6 Mutagenicity / genotoxicity According to the Applicant In in vitro assays with OPP and SOPP, minimal evidence of mutagenicity was observed, while clastogenicity occurred primarily in the presence of overt cytotoxicity. In vivo, micronucleus formation and/or DNA damage after oral or dermal ex","page":31,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_004"}
SCCS_vision_codex NOAEL =250 mg/kg bw/day rat oral chronic carcinogenicity {"dose":"The NOAEL was established at 250 mg/kg bw/day.","effect":"nicity studies conducted with OPP and SOPP via the oral route identified the urinary bladder and kidneys as the main target tissues in mice and rats. A combined chronic toxicity/carcinogenicity study in B6C3F1 mice revealed that OPP induced tumours in liver and changes in kidney tubule morphology. The liver tumours observed in male mice were attributed to the high spontaneous occurrence of liver tumours in this specific mouse strain. The kidney changes included hypertrophy and increased relative kidney weight. The NOAEL was established at 250 mg/kg bw/day. In chronic toxicity/carcinogenicity in rats, kidney effects such as hyperplasia, cysts, infarct, acute inflammation, and papilla mineralisation of the kidney were observed. Further, neoplastic changes related to urinary bladder such as increased incidences of transitional cell carcinomas, papilloma, and increased incidence of calculi, congestion, haemorrhage mineralization and necrosis in the urinary bladder were observed. Based on the above effects, the NOAEL of 39 mg/kg bw/da","page":35,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_005"}
SCCS_vision_codex NOAEL =39 mg/kg bw/day rat - chronic carcinogenicity {"dose":"The NOAEL was established at 250 mg/kg bw/day.","effect":"idney weight. The NOAEL was established at 250 mg/kg bw/day. In chronic toxicity/carcinogenicity in rats, kidney effects such as hyperplasia, cysts, infarct, acute inflammation, and papilla mineralisation of the kidney were observed. Further, neoplastic changes related to urinary bladder such as increased incidences of transitional cell carcinomas, papilloma, and increased incidence of calculi, congestion, haemorrhage mineralization and necrosis in the urinary bladder were observed. Based on the above effects, the NOAEL of 39 mg/kg bw/day was established. In another combined chronic and carcinogenicity study, rats exhibited an increased incidence of hepatocellular adenoma with extensive renal damage characterised by tubular dilation and varying degrees of acute and chronic inflammation at 1000 mg/kg bw/day. Furthermore, a 91-week study in male F344 rats associated OPP treatment with the development of urinary bladder tumours, such as papilloma and carcinoma, primarily transitional cell papilloma and carcinoma at and above 531 mg/","page":35,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_006"}
SCCS_vision_codex NOAEL =95 mg/kg bw/day rat dermal 2- year carcinogenicity {"dose":"The LOAEL for the first study was established at 224 mg/kg bw/day based on the increased incidence of focal atrophy of pancreas in females and the NOAEL was established at 95 mg/kg bw/day.","effect":"a 2- year carcinogenicity study (conducted in 2 parts) in F344 rats, SOPP induced kidney tumours and increased incidences of interstitial nephritis of the kidney and increased incidences of focal atrophy of pancreatic acinar cells in females. Additionally, there was an increased incidence of urinary bladder tumours, including transitional cell papillomas and carcinomas. The LOAEL for the first study was established at 224 mg/kg bw/day based on the increased incidence of focal atrophy of pancreas in females and the NOAEL was established at 95 mg/kg bw/day. In a 112-week study in F344 male rats, transitional cell carcinoma was observed in rats at and above 1500 mg/kg bw/day. In a 102-week dermal carcinogenicity study in Swiss CD-1 mice, OPP did not induce skin neoplasms. In a 52-week, two-stage mouse skin carcinogenesis study in female CD-1 mice, SOPP induced epidermal proliferation and can act as a promoter but not as an initiator or a complete carcinogen. Overall, OPP and SOPP did not induce tumours when applied dermally. However","page":35,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_008"}
SCCS_vision_codex NOAEL =49 mg/kg bw/day rat oral 13 weeks carcinogenicity {"dose":"ssation of 13 weeks of exposure to OPP) • Sex and species- and strain-specific differences (OPP-induced bladder tumours were not observed in female rats, mice, dogs) • dermal application to mice does not affect tumour incidence in skin • no skin tumour development induced by OPP metabolites • tumours occur at high doses when sulfate and glucuron...","effect":"ssation of 13 weeks of exposure to OPP) • Sex and species- and strain-specific differences (OPP-induced bladder tumours were not observed in female rats, mice, dogs) • dermal application to mice does not affect tumour incidence in skin • no skin tumour development induced by OPP metabolites • tumours occur at high doses when sulfate and glucuronide conjugation pathways are saturated The SCCS has noted the NOAELs proposed by the Applicant for OPP and SOPP for systemic toxicity and carcinogenicity (for OPP: lowest NOAEL established at 39 and 49 mg/kg bw/day in males and females, respectively; for SOPP, an oral LOAEL of 224 mg/kg bw/day from a 104-week carcinogenicity study in rats has been considered as most appropriate and conservative value for PoD derivation. The Applicant applied a composite uncertainty factor of 10 to account for the extrapolation from LOAEL to NOAEL and study data quality resulting in a corrected PoD of 22.4 mg/kg bw/day. The SCCS, however, stated in SCCS/1555/15 that the 104-week carcinogenicity study in r","page":37,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_009"}
SCCS_vision_codex NOAEL =22.4 mg/kg bw/day rat oral 104-week developmental toxicity {"dose":"ion pathways are saturated The SCCS has noted the NOAELs proposed by the Applicant for OPP and SOPP for systemic toxicity and carcinogenicity (for OPP: lowest NOAEL established at 39 and 49 mg/kg bw/day in males and females, respectively; for SOPP, an oral LOAEL of 224 mg/kg bw/day from a 104-week carcinogenicity study in rats has been considere...","effect":"ion pathways are saturated The SCCS has noted the NOAELs proposed by the Applicant for OPP and SOPP for systemic toxicity and carcinogenicity (for OPP: lowest NOAEL established at 39 and 49 mg/kg bw/day in males and females, respectively; for SOPP, an oral LOAEL of 224 mg/kg bw/day from a 104-week carcinogenicity study in rats has been considered as most appropriate and conservative value for PoD derivation. The Applicant applied a composite uncertainty factor of 10 to account for the extrapolation from LOAEL to NOAEL and study data quality resulting in a corrected PoD of 22.4 mg/kg bw/day. The SCCS, however, stated in SCCS/1555/15 that the 104-week carcinogenicity study in rats performed with SOPP was not performed according to currently accepted standards but that it can be used as supporting information. Therefore, the SCCS will use the NOAEL of 25 mg/kg bw/d obtained from a developmental toxicity study for MoS calculation of both OPP and SOPP. This value is supported by the Applicant’s corrected PoD for SOPP of 22.4 mg/kg","page":37,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_010"}
SCCS_vision_codex NOAEL =25 mg/kg bw/d rabbit oral developmental developmental toxicity {"dose":"ts) An aggregate value of 17.4 g/d (269 mg/kg bw/d) for the amount of cosmetics applied daily is taken for MoS calculation according to the SCCS's Notes of Guidance 12th revision.","effect":"ts) An aggregate value of 17.4 g/d (269 mg/kg bw/d) for the amount of cosmetics applied daily is taken for MoS calculation according to the SCCS's Notes of Guidance 12th revision. Absorption through the skin DAp (%) = 45 % Amount of cosmetic product applied daily A (g/d) = 14.54 g/d Concentration of ingredient in finished product C (%) = 0.15 % Typical body weight of human = 60 kg Systemic exposure dose (SED) = A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60 = 0.163 mg/kg bw/d No adverse observed effect level NOAEL = 25 mg/kg bw/d (oral developmental toxicity study, rabbit) No adjustment, 100 % oral absorption Margin of Safety adjusted NOAEL/SED = 153 OPP in rinse-off products An aggregate value of 0.54 g/d (8.3 mg/kg bw/d) for the amount of cosmetics applied daily is taken for MoS calculation, according to the SCCS's Notes of Guidance 12th revision. Absorption through the skin DAp (%) = 45 % Amount of cosmetic product applied daily A (g/d) = 0.54 g/d Concentration of ingredient in finished product C (%) = 0.2 % Typica","page":41,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_012"}
SCCS_vision_codex NOAEL =100 % rabbit oral developmental developmental toxicity {"dose":"Absorption through the skin DAp (%) = 45 % Amount of cosmetic product applied daily A (g/d) = 14.54 g/d Concentration of ingredient in finished product C (%) = 0.15 % Typical body weight of human = 60 kg Systemic exposure dose (SED) = A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60 = 0.163 mg/kg bw/d No adverse observed effect level NOAEL = 25...","effect":"ing to the SCCS's Notes of Guidance 12th revision. Absorption through the skin DAp (%) = 45 % Amount of cosmetic product applied daily A (g/d) = 14.54 g/d Concentration of ingredient in finished product C (%) = 0.15 % Typical body weight of human = 60 kg Systemic exposure dose (SED) = A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60 = 0.163 mg/kg bw/d No adverse observed effect level NOAEL = 25 mg/kg bw/d (oral developmental toxicity study, rabbit) No adjustment, 100 % oral absorption Margin of Safety adjusted NOAEL/SED = 153 OPP in rinse-off products An aggregate value of 0.54 g/d (8.3 mg/kg bw/d) for the amount of cosmetics applied daily is taken for MoS calculation, according to the SCCS's Notes of Guidance 12th revision. Absorption through the skin DAp (%) = 45 % Amount of cosmetic product applied daily A (g/d) = 0.54 g/d Concentration of ingredient in finished product C (%) = 0.2 % Typical body weight of human = 60 kg Systemic exposure dose (SED) = A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60 = 0.0081 mg/kg bw","page":41,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_013"}
SCCS_vision_codex NOAEL =10000 mg/kg bw/day rat oral Sub-acute repeated dose toxicity {"dose":"Repeated dose toxicity Oral repeated dose toxicity studies Study type, Species Doses Key findings NOAEL or LOAEL Reference#/ KL rating OPP Sub-acute studies 1-month dietary study in rats (strain not specified) (5 females/ group); no guideline 0, 2000, 3000, 4000, 5000 and 10000 mg/kg bw/day At 2000 mg/kg bw/day and slight growth retardation was...","effect":"SCCS/1669/24 Final version Opinion on the safety of Biphenyl-2-ol and Sodium 2-biphenylolate (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 65 9.4 ANNEX 4. Repeated dose toxicity Oral repeated dose toxicity studies Study type, Species Doses Key findings NOAEL or LOAEL Reference#/ KL rating OPP Sub-acute studies 1-month dietary study in rats (strain not specified) (5 females/ group); no guideline 0, 2000, 3000, 4000, 5000 and 10000 mg/kg bw/day At 2000 mg/kg bw/day and slight growth retardation was observed, all of the other dose groups lost weight rapidly. LOAEL: 2000 mg/kg bw/day Hodge et al., 1952 in (ECHA RAC, 2022)/KL2 32-day gavage study in male rats (15 males/ group); no guideline 0, 2, 20 and 200 mg/kg bw/day No treatment related adverse effects on any of parame","page":65,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_023"}
SCCS_vision_codex NOAEL =200 mg/kg bw/day rat oral Sub-acute repeated dose toxicity {"dose":"rating OPP Sub-acute studies 1-month dietary study in rats (strain not specified) (5 females/ group); no guideline 0, 2000, 3000, 4000, 5000 and 10000 mg/kg bw/day At 2000 mg/kg bw/day and slight growth retardation was observed, all of the other dose groups lost weight rapidly.","effect":"rating OPP Sub-acute studies 1-month dietary study in rats (strain not specified) (5 females/ group); no guideline 0, 2000, 3000, 4000, 5000 and 10000 mg/kg bw/day At 2000 mg/kg bw/day and slight growth retardation was observed, all of the other dose groups lost weight rapidly. LOAEL: 2000 mg/kg bw/day Hodge et al., 1952 in (ECHA RAC, 2022)/KL2 32-day gavage study in male rats (15 males/ group); no guideline 0, 2, 20 and 200 mg/kg bw/day No treatment related adverse effects on any of parameters at any dose level. NOAEL: 200 mg/kg bw/day Macintosh, 1945 in (ECHA RAC, 2022)/KL2 13-day gavage study in New Zealand rabbits (2 females/ dose); similar to OECD 407 0, 100, 500 and 1000 mg/kg bw/day At 1000 mg/kg bw/day, ↓ final body weight, ↓ in food consumption was observed. At 500 mg/kg bw/day, changes in body weight, food consumption, absolute/relative, kidney and liver weight were observed. At 100 mg/kg bw/day, ↓ absolute/relative, liver weight. NOAEL: 100 mg/kg bw/day (ECHA, 2023b; ECHA RAC, 2022)/KL2 4-week gavage study in Beagle","page":65,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_024"}
SCCS_vision_codex NOAEL =100 mg/kg bw/day rabbit oral 13-day NOAEL study {"dose":"w/day No treatment related adverse effects on any of parameters at any dose level.","effect":"w/day No treatment related adverse effects on any of parameters at any dose level. NOAEL: 200 mg/kg bw/day Macintosh, 1945 in (ECHA RAC, 2022)/KL2 13-day gavage study in New Zealand rabbits (2 females/ dose); similar to OECD 407 0, 100, 500 and 1000 mg/kg bw/day At 1000 mg/kg bw/day, ↓ final body weight, ↓ in food consumption was observed. At 500 mg/kg bw/day, changes in body weight, food consumption, absolute/relative, kidney and liver weight were observed. At 100 mg/kg bw/day, ↓ absolute/relative, liver weight. NOAEL: 100 mg/kg bw/day (ECHA, 2023b; ECHA RAC, 2022)/KL2 4-week gavage study in Beagle dogs (2/sex/dose); no guideline 0, 100, 200, 300 (400 mg up to Day 5, lowered to 300 due to emesis) mg/kg bw/day 5 days/week for 4 weeks At 300 mg/kg bw/day, ↓ RBC, Hb, HCT and platelet was observed. At 200 mg/kg bw/day, dose-related emesis in all dogs, ↓ RBC and HCT count was observed. NOAEL: 100 mg/kg bw/day Cosse et al. in (EC, 2023; ECHA RAC, 2022)/KL2","page":65,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_025"}
SCCS_vision_codex NOAEL =2.5 % rat oral Sub-chronic repeated dose toxicity {"dose":"90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 66 Study type, Species Doses Key findings NOAEL or LOAEL Reference#/ KL rating Sub-chronic studie...","effect":"SCCS/1669/24 Final version Opinion on the safety of Biphenyl-2-ol and Sodium 2-biphenylolate (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 66 Study type, Species Doses Key findings NOAEL or LOAEL Reference#/ KL rating Sub-chronic studies 13-week dietary study in F344/DuCrj Rats (10/sex/group); similar to OECD TG 408 0, 0.156, 0.313, 0.625, 1.25, and 2.5% OPP equivalent to 0, 182, 391, 761, 1669, and 2798 mg/kg bw/day in males and 0, 202, 411, 803, 1650, and 3014 mg/kg bw/day in females At 2798/3014 mg/kg bw/day, ↓ body weight, terminal body weight, food and water consumption, changes in organ weight, and histopathological changes in the kidney and bladder, and ↓ Red Blood Count (RBC), Haemoglobin","page":66,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_027"}
SCCS_vision_codex NOAEL =761 mg/kg bw/day rat oral 3 months NOAEL study {"dose":"At 1669/1650 mg/kg bw/day, ↓ body weight, food, and water consumption, ↓Hb and MCH level and ↑ relative liver weight, relative kidney weight, absolute bladder weight and abnormal growth in the bladder mucosa was observed.","effect":"gical changes in the kidney and bladder, and ↓ Red Blood Count (RBC), Haemoglobin (Hb), Mean Corpuscular Volume (MCV), Mean Corpuscular Haemoglobin (MCH) and Mean Corpuscular Haemoglobin Concentration (MCHC) was observed. At 1669/1650 mg/kg bw/day, ↓ body weight, food, and water consumption, ↓Hb and MCH level and ↑ relative liver weight, relative kidney weight, absolute bladder weight and abnormal growth in the bladder mucosa was observed. At 761/ 803 mg/kg bw/day, changes in liver and kidney weight were observed. NOAEL: 761 mg/kg bw/day Iguchi et al., 1984 in (EC, 2023; ECHA, 2023b; ECHA RAC, 2022)/KL2 3 months dietary study (strain not specified) in rats (12/sex/group); no guideline 0, 100, 300, 1000 and 2000 mg/kg bw/day At 2000 mg/kg bw/day, slight growth retardation, ↑ liver, kidney and. in some rats (no numerical data available) At 1000 mg/kg bw/day, ↑ liver, kidney, and spleen weight in some rats (no numerical data available). NOAEL: 1000 mg/kg bw/day Hodge et al., 1952 in (ECHA RAC, 2022)/KL4 6 months gavage study (strain","page":66,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_028"}
SCCS_vision_codex NOAEL =1000 mg/kg bw/day rat oral 3 months NOAEL study {"dose":"At 761/ 803 mg/kg bw/day, changes in liver and kidney weight were observed.","effect":"a was observed. At 761/ 803 mg/kg bw/day, changes in liver and kidney weight were observed. NOAEL: 761 mg/kg bw/day Iguchi et al., 1984 in (EC, 2023; ECHA, 2023b; ECHA RAC, 2022)/KL2 3 months dietary study (strain not specified) in rats (12/sex/group); no guideline 0, 100, 300, 1000 and 2000 mg/kg bw/day At 2000 mg/kg bw/day, slight growth retardation, ↑ liver, kidney and. in some rats (no numerical data available) At 1000 mg/kg bw/day, ↑ liver, kidney, and spleen weight in some rats (no numerical data available). NOAEL: 1000 mg/kg bw/day Hodge et al., 1952 in (ECHA RAC, 2022)/KL4 6 months gavage study (strain not specified) in rats 0, 50, 100, 200 and 500 mg/kg bw/day 5 days/week At 500 mg/kg bw/day ↑ liver and kidney NOAEL: 200 mg/kg bw/day Hodge et al., 1952 in (ECHA, 2023b;","page":66,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_029"}
SCCS_vision_codex NOAEL =500 mg/kg bw/day dog oral Chronic NOAEL study {"dose":"Similar to OECD TG 409 0, 20, 200, and 500 mg/kg bw/day At 500 mg/kg bw/day, ↑ kidney weight in males (no numerical data) was observed.","effect":"SCCS/1669/24 Final version Opinion on the safety of Biphenyl-2-ol and Sodium 2-biphenylolate (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 67 Study type, Species Doses Key findings NOAEL or LOAEL Reference#/ KL rating (12/sex/group); no guideline weight (no numerical data available). ECHA RAC, 2022) /KL4 Chronic studies 1-year dietary study (strain not specified) in dogs (1- 2/sex/group); Similar to OECD TG 409 0, 20, 200, and 500 mg/kg bw/day At 500 mg/kg bw/day, ↑ kidney weight in males (no numerical data) was observed. NOAEL: 200 mg/kg bw/day Hodge et al., 1952 in (EC, 2023; ECHA, 2023b; ECHA RAC, 2022)/KL2 1 year gavage study in Beagle dogs (4/sex/group); Similar to OECD TG 409 0, 30, 100, and","page":67,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_031"}
SCCS_vision_codex NOAEL =4294 mg/kg bw/day mouse oral Sub-chronic repeated dose toxicity {"dose":"g bw/day) At 2000 mg/kg bw/day, an ↑ in dark- stained cells and a few mitoses were observed.","effect":"g bw/day) At 2000 mg/kg bw/day, an ↑ in dark- stained cells and a few mitoses were observed. The authors suggest that these changes are the prodromal stage of the tumours induced by SOPP after longer treatment periods. Only bladder examined (once/week by transmission electron microscopy (TEM). LOAEL: 2000 mg/kg bw/day Fukumori et al. in (SCCS, 2015)/KL2 Sub-chronic studies 13-week dietary study in B6C3F1 mice 0, 0.25, 0.5, 1.0, 2.0 and 4.0% (correspond- ding to At 5375/6349 mg/kg bw/day, ↓ body weight, ↓ mean food NOAEL: 3529 and 4294 mg/kg bw/day for males Shibata et al., 1981, 1985 in (SCCS, 2015)/KL2","page":67,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_035"}
SCCS_vision_codex NOAEL =5375 mg/kg bw/day rat oral 13-week NOAEL study {"dose":"90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 68 Study type, Species Doses Key findings NOAEL or LOAEL Reference#/ KL rating (10/sex/group); no...","effect":"SCCS/1669/24 Final version Opinion on the safety of Biphenyl-2-ol and Sodium 2-biphenylolate (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 68 Study type, Species Doses Key findings NOAEL or LOAEL Reference#/ KL rating (10/sex/group); no guideline weighted average doses of 0, 451, 902, 1581, 3529 and 5375 mg/kg bw/day in males and 0, 488, 976, 1926, 4294 and 6349 mg/kg bw/day in females, respectively) intake, ↑ urinary pH value and ↓ urine density. and females, respectively 13-week dietary study in F344 rats (10/sex/group); no guideline 0, 0.125, 0.25, 0.5, 1, 2 and 4% (corresponding to 0, 85, 177, 353, 706, 1384 and 2487 in males and 0, 87, 177, 352, 694, 1338 and 2431 mg/kg bw/day in females, res","page":68,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_036"}
SCCS_vision_codex NOAEL =353 mg/kg bw/day rat oral 13-week NOAEL study {"dose":"les, respectively) intake, ↑ urinary pH value and ↓ urine density. and females, respectively 13-week dietary study in F344 rats (10/sex/group); no guideline 0, 0.125, 0.25, 0.5, 1, 2 and 4% (corresponding to 0, 85, 177, 353, 706, 1384 and 2487 in males and 0, 87, 177, 352, 694, 1338 and 2431 mg/kg bw/day in females, respectively) At 2431/2487 mg...","effect":"les, respectively) intake, ↑ urinary pH value and ↓ urine density. and females, respectively 13-week dietary study in F344 rats (10/sex/group); no guideline 0, 0.125, 0.25, 0.5, 1, 2 and 4% (corresponding to 0, 85, 177, 353, 706, 1384 and 2487 in males and 0, 87, 177, 352, 694, 1338 and 2431 mg/kg bw/day in females, respectively) At 2431/2487 mg/kg bw/day, ↓ body weight, moderate pyelonephritis was observed. At 1338/1384 mg/kg bw/day, ↓ body weight was observed. At 694/706 mg/kg bw/day, ↓ body weight was observed. NOAEL: 353 mg/kg bw/day Iguchi et al., 1979 in (SCCS, 2015)/KL2 13-week dietary study in F344 rats (20/sex/group); no guideline 0, 0.625, 1.25, and 2.5% (correspond- ding to weighted average doses of 0, 625 1250 and 2500 in males and 0, 706, 1411 and 2823 mg/kg bw/day in females, respectively) At 2500/2823 mg/kg bw/day, ↓ body weight gain was observed. At 1250/1411 mg/kg bw/day, ↓ body weight gain was observed. NOAEL: 625 mg/kg bw/day Nakamura et al., 1981 in (SCCS, 2015)/KL2 90-day dietary study in male F344 rats (grou","page":68,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_037"}
SCCS_vision_codex NOAEL =625 mg/kg bw/day rat oral 13-week NOAEL study {"dose":"1338/1384 mg/kg bw/day, ↓ body weight was observed.","effect":"1338/1384 mg/kg bw/day, ↓ body weight was observed. At 694/706 mg/kg bw/day, ↓ body weight was observed. NOAEL: 353 mg/kg bw/day Iguchi et al., 1979 in (SCCS, 2015)/KL2 13-week dietary study in F344 rats (20/sex/group); no guideline 0, 0.625, 1.25, and 2.5% (correspond- ding to weighted average doses of 0, 625 1250 and 2500 in males and 0, 706, 1411 and 2823 mg/kg bw/day in females, respectively) At 2500/2823 mg/kg bw/day, ↓ body weight gain was observed. At 1250/1411 mg/kg bw/day, ↓ body weight gain was observed. NOAEL: 625 mg/kg bw/day Nakamura et al., 1981 in (SCCS, 2015)/KL2 90-day dietary study in male F344 rats (group not specified); no guideline 0 and 2% (correspond- ding to weighted average doses of 2000 mg/kg bw/day) At 2000 mg/kg bw/day, ↑ thickness of the bladder epithelium from Day 14 until end of study (classified as hyperplasia with accompanying increased frequency of cell infiltration) was observed. LOAEL: 2000 mg/kg bw/day Reitz et al., 1983 in (SCCS, 2015)/KL2","page":68,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_038"}
SCCS_vision_codex NOAEL =1865 mg/kg bw/day mouse dermal 4-week repeated dose toxicity {"dose":"90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 69 Dermal repeated dose toxicity studies Study type, Species Doses Key findings NOAEL or LOAEL Re...","effect":"SCCS/1669/24 Final version Opinion on the safety of Biphenyl-2-ol and Sodium 2-biphenylolate (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 69 Dermal repeated dose toxicity studies Study type, Species Doses Key findings NOAEL or LOAEL Reference#/ KL rating OPP 4-week dermal toxicity study in Swiss Webster CFW mice (10/sex/group); no guideline 0, 5.95, 11.4, 20.8, 35.7 and 55.5 mg / 0.1 mL acetone (corresponding to weighted average doses of 0, 383.1, 699.08, 1200 and 1865 mg/kg bw/day for males 0, 460.21, 839.70, 1441.20 and 2240.53 mg/kg bw/day for females respectively) 3 days/week Ulcerative lesions at the site of application were observed in all mice that received ≤20.8 mg; in 6/10 males and 9/10 females that received 11.4 mg; in 2/1","page":69,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_039"}
SCCS_vision_codex NOAEL =490 mg/kg bw/day rat oral - reproductive toxicity {"dose":"0, 40, 140 and 490 mg/kg bw/day Actual:","effect":"SCCS/1669/24 Final version Opinion on the safety of Biphenyl-2-ol and Sodium 2-biphenylolate (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 70 9.5 ANNEX 5. Reproductive and development toxicity Overview of reproductive toxicity studies Study type, Species Doses Critical effects NOAEL or LOAEL Reference#/ KL rating OPP Two- generation dietary reproductive toxicity study, CD Sprague- Dawley rats, (32-35/sex group) OECD TG 416 Nominal: 0, 40, 140 and 490 mg/kg bw/day Actual: 0, 35, 125 and 457 mg/kg bw/day for 2 generations Parental effects At 457 mg/kg bw/day, ↓ body weight, body weight gain and terminal body weight in males and females, ↑ relative weight of ovaries in females, ↑ Incidence of renal calculi and haemorrhage in males. ↑ Incidence of bladder calculi and urinary bladder transitional","page":70,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_042"}
SCCS_vision_codex NOAEL =35 mg/kg bw/day - - - reproductive toxicity {"dose":"ght of testes and kidney in males, ↑ Incidence of urinary bladder transitional cell hyperplasia in males At 125 mg/kg bw/day Parental effects ↑ in body weight gain and changes in food consumptions, ↑ relative weight of ovaries in females, ↑ Incidence of average number cells/layer in females and ↑ Incidence of bladder calculi in males were observed.","effect":"ght of testes and kidney in males, ↑ Incidence of urinary bladder transitional cell hyperplasia in males At 125 mg/kg bw/day Parental effects ↑ in body weight gain and changes in food consumptions, ↑ relative weight of ovaries in females, ↑ Incidence of average number cells/layer in females and ↑ Incidence of bladder calculi in males were observed. F1 effects ↑ Absolute weight of liver and kidney and testes in males, ↓ incidence of average number of cells/layers of urinary bladder were observed. At 35 mg/kg bw/day NOAEL (systemic toxicity): 35 mg/kg bw/day NOAEL (reproductive toxicity): 457 mg/kg bw/day NOAEL (offspring toxicity): 125 mg/kg bw/day Eigenberg et al., 1990 in (ECHA RAC, 2022; ECHA, 2023b; SCCS, 2015)/KL2","page":70,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_043"}
SCCS_vision_codex NOAEL =457 mg/kg bw/day - - - reproductive toxicity {"dose":"asia in males At 125 mg/kg bw/day Parental effects ↑ in body weight gain and changes in food consumptions, ↑ relative weight of ovaries in females, ↑ Incidence of average number cells/layer in females and ↑ Incidence of bladder calculi in males were observed.","effect":"asia in males At 125 mg/kg bw/day Parental effects ↑ in body weight gain and changes in food consumptions, ↑ relative weight of ovaries in females, ↑ Incidence of average number cells/layer in females and ↑ Incidence of bladder calculi in males were observed. F1 effects ↑ Absolute weight of liver and kidney and testes in males, ↓ incidence of average number of cells/layers of urinary bladder were observed. At 35 mg/kg bw/day NOAEL (systemic toxicity): 35 mg/kg bw/day NOAEL (reproductive toxicity): 457 mg/kg bw/day NOAEL (offspring toxicity): 125 mg/kg bw/day Eigenberg et al., 1990 in (ECHA RAC, 2022; ECHA, 2023b; SCCS, 2015)/KL2","page":70,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_045"}
SCCS_vision_codex NOAEL =92 mg/kg bw/day rat - chronic reproductive toxicity {"dose":"0, 20, 100 and 500 mg/kg bw/day Actual:","effect":"wley rats, (30/sex/group ) OECD TG 416 Nominal: 0, 20, 100 and 500 mg/kg bw/day Actual: 18/17, 93/92 and 459/457 mg/kg bw/day for males and females, respectively Parental effects At 459/457 mg/kg bw/day, no treatment-related increase in mortality, changes in body weight and terminal body weight, ↓ food consumption in males and females, ↑ incidence of histopathological alterations in males: in the urinary bladder; chronic Inflammation, nodular/papillary; simple hyperplasia, and the ureter dilatation and hyperplasia NOAEL (systemic and offspring toxicity): 92 mg/kg bw/day NOAEL (reproductive toxicity): 457 mg/kg bw/day Eigenberg and Lake 1995 in (ECHA RAC, 2022; ECHA, 2023b; SCCS, 2015)/KL1","page":71,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_047"}
SCCS_vision_codex NOAEL =2100 mg/kg bw/day mouse oral Developmental reproductive toxicity {"dose":"At 93/92 mg/kg bw/day, no statistically significant treatment related effects were observed in Parents and F1 Reproductive parameters At 459/457 mg/kg bw/day, Parents, F1 and F2 - ↑ fertility index during F2b generation, ↑ food consumption during gestation was observed However, this increase in the fertility index is considered an artifact due t...","effect":"ia, and kidney debris were observed. At 93/92 mg/kg bw/day, no statistically significant treatment related effects were observed in Parents and F1 Reproductive parameters At 459/457 mg/kg bw/day, Parents, F1 and F2 - ↑ fertility index during F2b generation, ↑ food consumption during gestation was observed However, this increase in the fertility index is considered an artifact due to the extremely low fertility index for the control group. Developmental toxicity studies Study type, Species Doses Critical effects NOAEL or LOAEL Reference#/ KL rating OPP Prenatal developmental toxicity via gavage in JCL- ICR mice, (21 females/group), similar to OCED TG 414 0, 1450, 1740 and 2100 mg/kg bw/day, GD 7-15 Maternal toxicity At 2100 mg/kg bw/day, ↑ mortality: 5 mice died on GD 8, 7 on GD 9 and 2 each on GD 11 and 12, ↓ body weight/body weight gain and ↓ in absolute/relative heart weight were observed. At 1740 mg/kg bw/day, ↑ LOAEL (maternal and developmental toxicity): 1450 mg/kg bw/day Ogata et al., 1978 in (EC, 2023; ECHA, 2023b; ECHA","page":72,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_050"}
SCCS_vision_codex NOAEL =1450 mg/kg bw/day mouse - - reproductive toxicity {"dose":"At 1450 mg/kg bw/day, ↑ mortality:","effect":"SCCS/1669/24 Final version Opinion on the safety of Biphenyl-2-ol and Sodium 2-biphenylolate (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 73 Study type, Species Doses Critical effects NOAEL or LOAEL Reference#/ KL rating mortality: 4 mice died on GD 7 and 1 each on GD 14, GD 15, and GD 16, ↓ body weight/body weight gain (no numerical data available), ↓ in absolute/relative heart weight and ↑ in relative liver weight. At 1450 mg/kg bw/day, ↑ mortality: 1 mouse died each on GD 11 and 15, 2 mice died on GD 16. ↑ in absolute/relative liver weight. Litter/reproductive data At 2100 mg/kg bw/day, ↓ foetal bodyweight, ↑ frequency of foetuses with cervical ribs, ↓ mean number of ossified left/right phalanges","page":73,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_051"}
SCCS_vision_codex NOAEL =300 mg/kg bw/day rat oral Prenatal developmental toxicity {"dose":"Prenatal developmental toxicity via gavage in SD rat, (25-35 females/group), similar to OCED TG 414 0, 100, 300 and 700 mg/kg bw/day, GD 6-15 Maternal toxicity At 700 mg/kg bw/day, ↓ body weight, body weight gain and absolute liver wight was observed.","effect":"↓ foetal body weight, ↑ frequency of foetuses with cervical ribs, ↓ mean number of ossified left/right phalanges in hindlegs, ↑ frequency of foetuses with externally visible malformations. Prenatal developmental toxicity via gavage in SD rat, (25-35 females/group), similar to OCED TG 414 0, 100, 300 and 700 mg/kg bw/day, GD 6-15 Maternal toxicity At 700 mg/kg bw/day, ↓ body weight, body weight gain and absolute liver wight was observed. At 300 mg/kg bw/day, decreased weight gain (not statistically significant) and NOAEL (maternal and evelopmental): 300 mg/kg bw/day (whereas SCCS has derived maternal NOAEL at 150 mg/kg bw/day) John et al., 1978 in (ECHA, 2023b)/KL2","page":73,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_052"}
SCCS_vision_codex NOAEL =150 mg/kg bw/day rat oral Prenatal developmental toxicity {"dose":"Prenatal developmental toxicity via gavage in SD rat, (25-35 females/group), similar to OCED TG 414 0, 100, 300 and 700 mg/kg bw/day, GD 6-15 Maternal toxicity At 700 mg/kg bw/day, ↓ body weight, body weight gain and absolute liver wight was observed.","effect":"fied left/right phalanges in hindlegs, ↑ frequency of foetuses with externally visible malformations. Prenatal developmental toxicity via gavage in SD rat, (25-35 females/group), similar to OCED TG 414 0, 100, 300 and 700 mg/kg bw/day, GD 6-15 Maternal toxicity At 700 mg/kg bw/day, ↓ body weight, body weight gain and absolute liver wight was observed. At 300 mg/kg bw/day, decreased weight gain (not statistically significant) and NOAEL (maternal and evelopmental): 300 mg/kg bw/day (whereas SCCS has derived maternal NOAEL at 150 mg/kg bw/day) John et al., 1978 in (ECHA, 2023b)/KL2","page":73,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_053"}
SCCS_vision_codex NOAEL =700 mg/kg bw/day rat oral Developmental developmental toxicity {"dose":"Developmental toxicity At 700 mg/kg bw/day, ↑Incidence of post- implantation loss in foetuses and litters were observed.","effect":"SCCS/1669/24 Final version Opinion on the safety of Biphenyl-2-ol and Sodium 2-biphenylolate (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 74 Study type, Species Doses Critical effects NOAEL or LOAEL Reference#/ KL rating reduced food consumption was observed. Developmental toxicity At 700 mg/kg bw/day, ↑Incidence of post- implantation loss in foetuses and litters were observed. Skeletal alteration: ↑Incidence foetuses with: Delayed ossification of sternebrae foetuses, skull foramen, skull bone island Prenatal developmental toxicity via gavage in Wistar rats, (11-20 females/group), similar to OCED TG 414 0, 150, 300, 600 and 1200 mg/kg bw/day, GD 6-15 Maternal toxicity At 1200 mg/kg bw/day, 10/11 dams","page":74,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_054"}
SCCS_vision_codex NOAEL =600 mg/kg bw/day rat oral Developmental developmental toxicity {"dose":"At 600 mg/kg bw/day, ↓ body weight gain, clinical signs such as pregnant rats fell into ataxia for several hours.","effect":"xia for several hours. At 600 mg/kg bw/day, ↓ body weight gain, clinical signs such as pregnant rats fell into ataxia for several hours. At 300 mg/kg bw/day, ↓ body weight gain, clinical signs such as pregnant rats fell into ataxia for several hours. Developmental toxicity At 600 mg/kg bw/day, ↑ percentage of foetal death, ↓ mean foetal weight, ↑ foetal incidence of malformations. At 300 mg/kg bw/day, ↑ foetal incidence of malformations NOAEL (maternal and developmental): 150 mg/kg bw/day Note: SCCS considered the NOAEL for developmental at 600 mg/kg bw/day) Kaneda et al., 1978 in (ECHA, 2023b; ECHA RAC, 2022; SCCS, 2015)/KL2 Range finding Prenatal developmental toxicity via gavage in New Zealand rabbits, (7 females/ group), no guideline 0, 250, 500 and 750 mg/ kg bw/day GD 7-19 Maternal toxicity At 750 mg/kg bw/day, mortality: nine rabbits died prior to study termination. Two rabbits (one at 500 and one at 750 mg/kg bw/day) were found withdepositions of the test material in the lungs. The remaining deaths were considered treatme","page":74,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_056"}
SCCS_vision_codex NOAEL =400 mg/ kg bw/ day mouse oral Prenatal developmental toxicity {"dose":"90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 76 Study type, Species Doses Critical effects NOAEL or LOAEL Reference#/ KL rating SOPP Prenatal...","effect":"SCCS/1669/24 Final version Opinion on the safety of Biphenyl-2-ol and Sodium 2-biphenylolate (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 76 Study type, Species Doses Critical effects NOAEL or LOAEL Reference#/ KL rating SOPP Prenatal developmental toxicity via gavage in JCL- ICR mice, (20 females/group), similar to OCED TG 414 0, 100, 200 and 400 mg/ kg bw/ day, GD 7-15 Maternal toxicity At 400 mg/kg bw/day, ↑ mortality (80% of unscheduled deaths), ↓ body weight and body weight gain, ↓ absolute weight of liver, heart, and spleen. At 200 mg/kg bw/day, ↑ mortality (20% of unscheduled deaths), ↓ body weight and body weight gain, ↑ relative lung weight at 100 mg/kg bw/day, ↓ body weight and body wei","page":76,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_061"}
SCCS_vision_codex NOAEL =269 mg/kg bw/day rat - 2-year carcinogenicity {"dose":"At 531 mg/kg bw/day, haematuria, ↓body weights, proliferative lesions in the urinary bladder, and moderate to severe nephritic lesions and urinary bladder tumours (papilloma and carcinoma, mainly transitional cell papilloma and carcinoma) were observed.","effect":"/day, ↑white blood cell count, haematuria, ↓body weights, proliferative lesions in the urinary bladder, and moderate to severe nephritic lesions and urinary bladder tumours (papilloma and carcinoma, mainly transitional cell papilloma and carcinoma). were observed. At 531 mg/kg bw/day, haematuria, ↓body weights, proliferative lesions in the urinary bladder, and moderate to severe nephritic lesions and urinary bladder tumours (papilloma and carcinoma, mainly transitional cell papilloma and carcinoma) were observed. NOAEL (carcinogenicity): 269 mg/kg bw/day Hiraga K., and Fujii T. 1984 in (EC, 2023; ECHA, 2023b; ECHA RAC, 2022; SCCS, 2015)/KL2 2-year combined chronic toxicity/ carcinogenicity study in CDF[F344]/BR rats 0, 800, 4000 and 8000/ 10000 ppm (equivalent to 0, 39/49, 200/248 and 402/647 mg/kg bw/day in At 402/647 mg/kg bw/day, ↑ incidence of urinary bladder masses, ↑ incidence of pitted zones in kidneys. Neoplastic changes such as ↑ incidence of transitional NOAEL (carcinogenicity and systemic toxicity): 39 and 49 mg/kg bw","page":93,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_067"}
SCCS_vision_codex NOAEL =248 mg/kg bw/day - - - NOAEL study {"dose":"At 200/248 mg/kg bw/day, neoplastic changes in the urinary bladder, such as ↑ incidence of transitional cell carcinomas in males, ↓ body weight, body weight gain, food consumption and food efficiency, ↑clinical signs and gross pathological signs of toxicity. and females, respectively SCCS, 2015;","effect":"SCCS/1669/24 Final version Opinion on the safety of Biphenyl-2-ol and Sodium 2-biphenylolate (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 94 Study type, Species Doses Key findings NOAEL/ LOAEL Reference / KL rating (50/sex/group); OECD TG 453 males/females, respectively cell carcinomas, ↑ incidence of papillomas in males was observed. Non-neoplastic changes in the urinary bladder and kidney were observed. At 200/248 mg/kg bw/day, neoplastic changes in the urinary bladder, such as ↑ incidence of transitional cell carcinomas in males, ↓ body weight, body weight gain, food consumption and food efficiency, ↑clinical signs and gross pathological signs of toxicity. and females, respectively SCCS, 2015;","page":94,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_069"}
SCCS_vision_codex NOAEL =3081 mg/kg bw/day - oral 96-week NOAEL study {"dose":"Systemically, slightly increased incidences of dilatation of the kidney tubules compared to acetone controls were observed in OPP treated animals.","effect":"effect. Systemically, slightly increased incidences of dilatation of the kidney tubules compared to acetone controls were observed in OPP treated animals. In males, a greater incidence of focal necrosis of the liver (of mild degree) was observed. OPP, alone or after tumour initiation with DMBA, did not increase the incidence of neoplastic skin lesions when applied dermally over two years National Toxicology Program, 1986 in (SCCS, 2015)/KL2 SOPP Oral 96-week dietary 0, 0.5, 1.0 and 2.0% At 3009/3081 mg/kg bw/day, NOAEL Hagiwara et","page":94,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_071"}
SCCS_vision_codex NOAEL =3009 mg/kg bw/day mouse - - NOAEL study {"dose":"90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 95 Study type, Species Doses Key findings NOAEL/ LOAEL Reference / KL rating study in B6C3F1 mice...","effect":"SCCS/1669/24 Final version Opinion on the safety of Biphenyl-2-ol and Sodium 2-biphenylolate (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 95 Study type, Species Doses Key findings NOAEL/ LOAEL Reference / KL rating study in B6C3F1 mice (50/sex/group); no guideline equivalent to 0, 591, 1451, and 3009 mg/kg bw/day for the males and 0, 480, 1464, and 3081 mg/kg bw/day for the females, respectively ↑hepatocellular carcinomas and calcification of the brain were observed. At 1451/1464 mg/kg bw/day ↑ haemangiosarcomas of the liver, ↑hepatocellular carcinomas were observed. At 480 mg/kg bw/day, cystic endometrial hyperplasia of the uterus in females was observed in females. Authors considered increased","page":95,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_072"}
SCCS_vision_codex NOAEL =125 mg/kg bw/day - oral 2-year carcinogenicity {"dose":"no guideline 0, 0.125, 0.25, 0.5, 1.0, 2.0 and 4.0% equivalent to 0, 62, 125, 250, 500, 1000 and 2000 mg/kg bw/dayk At 2000 mg/kg bw/day, ↑incidence of carcinoma in the renal papilla was observed.","effect":"no guideline 0, 0.125, 0.25, 0.5, 1.0, 2.0 and 4.0% equivalent to 0, 62, 125, 250, 500, 1000 and 2000 mg/kg bw/dayk At 2000 mg/kg bw/day, ↑incidence of carcinoma in the renal papilla was observed. At 1000 mg/kg bw/day, ↑ in the incidence of tumours of the urinary system and carcinosarcoma was observed. At 500 mg/kg bw/day, ↑in the incidence of tumours of the urinary system was observed. At 250 mg/kg bw/day, ↑in the incidence of tumours of the urinary system was observed. Haematuria was observed at all dose levels. NOAEL (carcinogenicity): 125 mg/kg bw/day LOAEL (systemic toxicity): 62 mg/kg bw/day Hiraga et al..., 1981 in (SCCS, 2015)/KL2 2-year dietary carcinogenicity 1st study: Males: 0, 7000 and 20000 ppm, At 466/770 mg/kg bw/day, ↑ focal atrophy of the LOAEL (carcinogenicity Hiraga et al..., 1983 in (SCCS,","page":95,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_073"}
SCCS_vision_codex NOAEL =770 mg/kg bw/day rat - - NOAEL study {"dose":"90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 96 Study type, Species Doses Key findings NOAEL/ LOAEL Reference / KL rating study in F344 rats (...","effect":"SCCS/1669/24 Final version Opinion on the safety of Biphenyl-2-ol and Sodium 2-biphenylolate (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 96 Study type, Species Doses Key findings NOAEL/ LOAEL Reference / KL rating study in F344 rats (50/sex/group); no guideline equivalent to 0, 270 and 770 mg/kg bw/day, respectively) and Females: 0, 5000 and 10000 ppm equivalent to 0, 224 and 466 mg/kg bw/day, respectively pancreas and ↑ incidences of interstitial nephritis of the kidney were observed. At 466/770 mg/kg bw/day in the kidneys, both non- neoplastic changes (interstitial nephritis and pyelonephritis) and neoplastic changes (transitional cell papilloma and carcinoma) occurred in low incidences in the","page":96,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_074"}
SCCS_vision_codex NOAEL =395 mg/kg bw/day rat - 2-year carcinogenicity {"dose":"95 mg/kg bw/day 2-year carcinogenicity study in male F344 rats (groups not specified); no guideline 0, 0.25, 0.5, 1.0 and 2.0% equivalent to approximately 0, 197, 395, 780 and 1579 mg/kg bw/dayl At 1579 mg/kg bw/day, hyperplasia of bladder was observed.","effect":"kidney, urinary bladder papillomas and/or carcinomas were observed. NOAEL (carcinogenicity and systemic toxicity): 95 mg/kg bw/day 2-year carcinogenicity study in male F344 rats (groups not specified); no guideline 0, 0.25, 0.5, 1.0 and 2.0% equivalent to approximately 0, 197, 395, 780 and 1579 mg/kg bw/dayl At 1579 mg/kg bw/day, hyperplasia of bladder was observed. Development of papilloma and carcinoma was observed after 36 weeks. At 780 mg/kg bw/day, development of simple hyperplasia from week 36 was observed. NOAEL (carcinogenicity and systemic toxicity): 395 mg/kg bw/day Fukushima et al..., 1982 in (SCCS, 2015)/KL4 112-week carcinogenicity 0, 2500, 5000, 10000, 15000 and 20000 ppm At 1500 mg/kg bw/day, transitional cell carcinoma NOAEL (carcinogenicity Niho et al..., 2002 in (SCCS,","page":96,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_076"}
SCCS_vision_codex NOAEL =1500 mg/kg bw/day - - 36 weeks carcinogenicity {"dose":".5, 1.0 and 2.0% equivalent to approximately 0, 197, 395, 780 and 1579 mg/kg bw/dayl At 1579 mg/kg bw/day, hyperplasia of bladder was observed.","effect":".5, 1.0 and 2.0% equivalent to approximately 0, 197, 395, 780 and 1579 mg/kg bw/dayl At 1579 mg/kg bw/day, hyperplasia of bladder was observed. Development of papilloma and carcinoma was observed after 36 weeks. At 780 mg/kg bw/day, development of simple hyperplasia from week 36 was observed. NOAEL (carcinogenicity and systemic toxicity): 395 mg/kg bw/day Fukushima et al..., 1982 in (SCCS, 2015)/KL4 112-week carcinogenicity 0, 2500, 5000, 10000, 15000 and 20000 ppm At 1500 mg/kg bw/day, transitional cell carcinoma NOAEL (carcinogenicity Niho et al..., 2002 in (SCCS,","page":96,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_077"}
SCCS_vision_codex NOAEL =2000 mg/kg bw/day rat dermal 52-week NOAEL study {"dose":"90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 97 Study type, Species Doses Key findings NOAEL/ LOAEL Reference / KL rating study in male F344 r...","effect":"SCCS/1669/24 Final version Opinion on the safety of Biphenyl-2-ol and Sodium 2-biphenylolate (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 97 Study type, Species Doses Key findings NOAEL/ LOAEL Reference / KL rating study in male F344 rats (50 /group) equivalent to approximately 250, 500, 1000, 1500 and 2000 mg/kg bw/day was observed in rats. At 1500 mg/kg bw/day and above, urinary bladder tumour formation was observed. and systemic toxicity): 1000 mg/kg bw/day 2015{Cal EPA, 2007 #4752)} /KL2 Dermal 52-week, two- stage mouse skin carcinogenesis study in female CD-1 mice Initiation: SOPP in DMSO (10 mg/100 µL) or DMBA ( (10 µg/100 µl) twice weekly for 5 weeks. Promotion: starting 1 week after last","page":97,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_078"}
SCCS_vision_codex NOAEL =224 mg/kg bw/day rat - - carcinogenicity {"dose":"In the first study, the LOAEL for systemic toxicity and carcinogenicity was established at 270 and 224 mg/kg bw/day in males and females, respectively.","effect":"isher Exact test, as calculated by DPR in Cal EPA, 2007: significant at p<0.05, p<0.01, p<0.001, respectively. +,++,+++ Cochran-Armitage trend test, as calculated by DPR in Cal EPA, 2007; significant at p<0.05, p<0.01, and p<0.001, respectively. Conclusion Under the study conditions, SOPP was assessed to be carcinogenic in Fischer 344 rats. In the first study, the LOAEL for systemic toxicity and carcinogenicity was established at 270 and 224 mg/kg bw/day in males and females, respectively. In the second study, the NOAEL for both systemic toxicity and carcinogenicity was established at 95 and 113 mg/kg bw/day in males and females, respectively. Note: The non-neoplastic changes such as interstitial nephritis and pyelonephritis and neoplastic changes such as transitional cell papilloma and carcinoma in the kidneys and carcinomas/papilloma induced in the bladder at 224/270 mg/kg bw/day did not reach statistical significance. However, in their evaluation, Cal EPA (2007) considered the observations to be treatment-related findings beca","page":102,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_081"}
SCCS_vision_codex NOAEL =65 - - - - NOAEL study {"effect":"Unlabeled table on page 65: Study type, | Doses | Key findings | NOAEL or | Reference#/ KL rating","page":65,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_082"}
SCCS_vision_codex NOAEL =66 - - - - NOAEL study {"effect":"Unlabeled table on page 66: Study type, Species | Doses | Key findings | NOAEL or LOAEL | Reference#/ KL rating","page":66,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_089"}
SCCS_vision_codex NOAEL =67 - - - - NOAEL study {"effect":"Unlabeled table on page 67: Study type, Species | Doses | Key findings | NOAEL or LOAEL | Reference#/ KL rating","page":67,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_096"}
SCCS_vision_codex NOAEL =4 % mouse oral 13-week NOAEL study {"dose":"13-week dietary study in B6C3F1 mice | 0, 0.25, 0.5, 1.0, 2.0 and 4.0% (correspond- ding to | At 5375/6349 mg/kg bw/day, ↓ body weight, ↓ mean food | NOAEL:","effect":"Unlabeled table on page 67: 13-week dietary study in B6C3F1 mice | 0, 0.25, 0.5, 1.0, 2.0 and 4.0% (correspond- ding to | At 5375/6349 mg/kg bw/day, ↓ body weight, ↓ mean food | NOAEL: 3529 and 4294 mg/kg bw/day for males | Shibata et al., 1981, 1985 in (SCCS, 2015)/KL2","page":67,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_099"}
SCCS_vision_codex NOAEL =68 - - - - NOAEL study {"effect":"Unlabeled table on page 68: Study type, Species | Doses | Key findings | NOAEL or LOAEL | Reference#/ KL rating","page":68,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_104"}
SCCS_vision_codex NOAEL =69 - - - - NOAEL study {"effect":"Unlabeled table on page 69: Study type, Species | Doses | Key findings | NOAEL or LOAEL","page":69,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_111"}
SCCS_vision_codex NOAEL =240 mg/kg bw/day mouse dermal 4-week NOAEL study {"dose":"4-week dermal toxicity study in Swiss Webster CFW mice (10/sex/group); no guideline | 0, 5.95, 11.4, 20.8, 35.7 and 55.5 mg / 0.1 mL acetone (corresponding to weighted average doses of 0, 383.1, 699.08, 1200 and 1865 mg/kg bw/day for males 0, 460.21, 839.70, 1441.20 and 2240.53 mg/kg bw/day for females respectively) 3 days/week | Ulcerative lesi...","effect":"Unlabeled table on page 69: 4-week dermal toxicity study in Swiss Webster CFW mice (10/sex/group); no guideline | 0, 5.95, 11.4, 20.8, 35.7 and 55.5 mg / 0.1 mL acetone (corresponding to weighted average doses of 0, 383.1, 699.08, 1200 and 1865 mg/kg bw/day for males 0, 460.21, 839.70, 1441.20 and 2240.53 mg/kg bw/day for females respectively) 3 days/week | Ulcerative lesions at the site of application were observed in all mice that received ≤20.8 mg; in 6/10 males and 9/10 females that received 11.4 mg; in 2/10 males and 7/10 females that received 5.95 mg, and in 1/10 male and 1/10 female of control group | LOAEL (dermal toxicity): 5.95 mg (equivalent to 200 / 240 mg/kg bw/day for males and females, respectively) | NTP, 1986 in ECHA RAC, 2022/KL2","page":69,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_113"}
SCCS_vision_codex NOAEL =70 - - - - NOAEL study {"effect":"Unlabeled table on page 70: Study type, Species | Doses | Critical effects | NOAEL or LOAEL | Reference#/ KL rating","page":70,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_115"}
SCCS_vision_codex NOAEL =71 - - - - NOAEL study {"effect":"Unlabeled table on page 71: Study type, Species | Doses | Critical effects | NOAEL or LOAEL | Reference#/ KL rating","page":71,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_118"}
SCCS_vision_codex NOAEL =72 - - - - NOAEL study {"effect":"Unlabeled table on page 72: Study type, Species | Doses | Critical effects | NOAEL or LOAEL | Reference#/ KL rating","page":72,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_121"}
SCCS_vision_codex NOAEL =73 - - - - NOAEL study {"effect":"Unlabeled table on page 73: Study type, Species | Doses | Critical effects | NOAEL or LOAEL | Reference#/ KL rating","page":73,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_123"}
SCCS_vision_codex NOAEL =74 - - - - NOAEL study {"effect":"Unlabeled table on page 74: Study type, Species | Doses | Critical effects | NOAEL or LOAEL | Reference#/ KL rating","page":74,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_126"}
SCCS_vision_codex NOAEL =1200 mg/kg bw/day rat oral Prenatal developmental toxicity {"dose":"Prenatal developmental toxicity via gavage in Wistar rats, (11-20 females/group), similar to OCED TG 414 | 0, 150, 300, 600 and 1200 mg/kg bw/day, GD 6-15 | Maternal toxicity At 1200 mg/kg bw/day, 10/11 dams died after 3-9 days of treatment, clinical signs such as pregnant rats fell into ataxia for several hours.","effect":"Unlabeled table on page 74: Prenatal developmental toxicity via gavage in Wistar rats, (11-20 females/group), similar to OCED TG 414 | 0, 150, 300, 600 and 1200 mg/kg bw/day, GD 6-15 | Maternal toxicity At 1200 mg/kg bw/day, 10/11 dams died after 3-9 days of treatment, clinical signs such as pregnant rats fell into ataxia for several hours. At 600 mg/kg bw/day, ↓ body weight gain, clinical signs such as pregnant rats fell into ataxia for several hours. At 300 mg/kg bw/day, ↓ body weight gain, clinical signs such as pregnant rats fell into ataxia for several hours. Developmental toxicity At 600 mg/kg bw/day, ↑ percentage of foetal death, ↓ mean foetal weight, ↑ foetal incidence of malformations. At 300 mg/kg bw/day, ↑ foetal incidence of malformations | NOAEL (maternal and developmental): 150 mg/kg bw/day Note: SCCS considered the NOAEL for developmental at 600 mg/kg bw/day) | Kaneda et al., 1978 in (ECHA, 2023b; ECHA RAC, 2022; SCCS, 2015)/KL2","page":74,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_127"}
SCCS_vision_codex NOAEL =750 mg/ kg bw/day rabbit oral Prenatal developmental toxicity {"dose":"Range finding Prenatal developmental toxicity via gavage in New Zealand rabbits, (7 females/ group), no guideline | 0, 250, 500 and 750 mg/ kg bw/day GD 7-19 | Maternal toxicity At 750 mg/kg bw/day, mortality: nine rabbits died prior to study termination.","effect":"Unlabeled table on page 74: Range finding Prenatal developmental toxicity via gavage in New Zealand rabbits, (7 females/ group), no guideline | 0, 250, 500 and 750 mg/ kg bw/day GD 7-19 | Maternal toxicity At 750 mg/kg bw/day, mortality: nine rabbits died prior to study termination. Two rabbits (one at 500 and one at 750 mg/kg bw/day) were found withdepositions of the test material in the lungs. The remaining deaths were considered treatment related. ↓ body weight and | LOAEL (maternal toxicity): 250 mg/kg bw/day; Developmental NOAEL cannot be established, since foetuses were not examined for skeletal, visceral, and external anomalies | Zablotny et al., 1991, in (ECHA RAC, 2022; SCCS, 2015) /KL2","page":74,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_128"}
SCCS_vision_codex NOAEL =75 - - - - NOAEL study {"effect":"Unlabeled table on page 75: Study type, Species | Doses | Critical effects | NOAEL or LOAEL | Reference#/ KL rating","page":75,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_131"}
SCCS_vision_codex NOAEL =76 - - - - NOAEL study {"effect":"Unlabeled table on page 76: Study type, Species | Doses | Critical effects | NOAEL or LOAEL | Reference#/ KL rating","page":76,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_134"}
SCCS_vision_codex NOAEL =93 - - - - NOAEL study {"effect":"Unlabeled table on page 93: Study type, Species | Doses | Key findings | NOAEL/ LOAEL | Reference / KL rating","page":93,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_136"}
SCCS_vision_codex NOAEL =10000 ppm rat - 2-year carcinogenicity {"dose":"2-year combined chronic toxicity/ carcinogenicity study in CDF[F344]/BR rats | 0, 800, 4000 and 8000/ 10000 ppm (equivalent to 0, 39/49, 200/248 and 402/647 mg/kg bw/day in | At 402/647 mg/kg bw/day, ↑ incidence of urinary bladder masses, ↑ incidence of pitted zones in kidneys.","effect":"Unlabeled table on page 93: 2-year combined chronic toxicity/ carcinogenicity study in CDF[F344]/BR rats | 0, 800, 4000 and 8000/ 10000 ppm (equivalent to 0, 39/49, 200/248 and 402/647 mg/kg bw/day in | At 402/647 mg/kg bw/day, ↑ incidence of urinary bladder masses, ↑ incidence of pitted zones in kidneys. Neoplastic changes such as ↑ incidence of transitional | NOAEL (carcinogenicity and systemic toxicity): 39 and 49 mg/kg bw/day in males | Wahle et al...,1996 in (ECHA, 2023b; ECHA RAC, 2022;","page":93,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_139"}
SCCS_vision_codex NOAEL =94 - - - - NOAEL study {"effect":"Unlabeled table on page 94: Study type, Species | Doses | Key findings | NOAEL/ LOAEL | Reference / KL rating","page":94,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_143"}
SCCS_vision_codex NOAEL =2 % rat - 2-year carcinogenicity {"dose":"Similar to OECD TG 453 | 0, 0.02, 0.2 and 2% equivalent to 0, 10, 100 and 1000 mg/kg bw/day | At 1000 mg/kg bw/day, ↓ body weight, ↑weight of testes and histopathological changes such as extensive renal damage, characterised by tubular dilation with varying degrees of acute and chronic inflammation was observed. | NOAEL:","effect":"Unlabeled table on page 94: 2-year combined chronic toxicity/ carcinogenicity study in weanling Rochester rats (25/sex/group); Similar to OECD TG 453 | 0, 0.02, 0.2 and 2% equivalent to 0, 10, 100 and 1000 mg/kg bw/day | At 1000 mg/kg bw/day, ↓ body weight, ↑weight of testes and histopathological changes such as extensive renal damage, characterised by tubular dilation with varying degrees of acute and chronic inflammation was observed. | NOAEL: 100 mg/kg bw/day | Hodge HC., et al... 1952 in (EC, 2023)/KL2","page":94,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_144"}
SCCS_vision_codex NOAEL =95 - - - - NOAEL study {"effect":"Unlabeled table on page 95: Study type, Species | Doses | Key findings | NOAEL/ LOAEL | Reference / KL rating","page":95,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_148"}
SCCS_vision_codex NOAEL =20000 ppm - oral 2-year carcinogenicity {"dose":"0, 7000 and 20000 ppm, | At 466/770 mg/kg bw/day, ↑ focal atrophy of the | LOAEL (carcinogenicity | Hiraga et al..., 1983 in (SCCS,","effect":"Unlabeled table on page 95: 2-year dietary carcinogenicity | 1st study: Males: 0, 7000 and 20000 ppm, | At 466/770 mg/kg bw/day, ↑ focal atrophy of the | LOAEL (carcinogenicity | Hiraga et al..., 1983 in (SCCS,","page":95,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_152"}
SCCS_vision_codex NOAEL =96 - - - - NOAEL study {"effect":"Unlabeled table on page 96: Study type, Species | Doses | Key findings | NOAEL/ LOAEL | Reference / KL rating","page":96,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_153"}
SCCS_vision_codex NOAEL =97 - - - - NOAEL study {"effect":"Unlabeled table on page 97: Study type, Species | Doses | Key findings | NOAEL/ LOAEL | Reference / KL rating","page":97,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_160"}
SCCS_vision_codex NOAEL =25 mg/kg bw/day rat - developmental developmental toxicity {"dose":"As a result, the LOAEL was established at 1450 mg/kg bw/day.","effect":"l effects were observed at all tested doses. As a result, the LOAEL was established at 1450 mg/kg bw/day. Similarly, an increased incidence of resorptions was reported in rat developmental toxicity studies with OPP. The lowest NOAELs identified for maternal and developmental effects were 100 and 300 mg/kg bw/day, respectively. In rabbits, no adverse effects on foetuses were observed. However, increased incidences of resorptions were noted, and these appeared to be independent of maternal toxicity. As a result, the NOAEL for developmental toxicity was established at 25 mg/kg bw/day. In the mouse study with SOPP, developmental effects, such as reduced foetal weight and an increased incidence of cleft palate, were observed even at the lowest dose tested (100 mg/kg bw/day). The only developmental toxicity study with SOPP, is not considered to be useful in safety assessment due to design and reporting limitations. However, it did suggest SOPP's potential interference with rodent development. In summary, while OPP did not adversely aff","page":31,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_001"}
SCCS_vision_codex NOAEL =25 mg/kg/d rabbit oral developmental reproductive toxicity {"dose":"In summary, while OPP did not adversely affect fertility or reproductive organs, the increased incidence of resorptions can be considered a developmental effect of both OPP and SOPP with a critical NOAEL of 25 mg/kg bw/day.","effect":"potential interference with rodent development. In summary, while OPP did not adversely affect fertility or reproductive organs, the increased incidence of resorptions can be considered a developmental effect of both OPP and SOPP with a critical NOAEL of 25 mg/kg bw/day. SCCS comment on developmental toxicity In SCCS/1555/15, the SCCS derived a NOAEL of 25 mg/kg/d based on a re-analysis by Kwock and Silva (2013) of data from a teratology study performed in New Zealand White Rabbits (Zablotny et al., 1991b). This NOAEL is lower than other PoDs obtained from other repeat- dose/long-term toxicity studies performed with OPP and SOPP. Therefore, this conservative value of 25 mg/kg bw/d is taken for MoS calculation for both, OPP and SOPP. 3.4.6 Mutagenicity / genotoxicity According to the Applicant In in vitro assays with OPP and SOPP, minimal evidence of mutagenicity was observed, while clastogenicity occurred primarily in the presence of overt cytotoxicity. In vivo, micronucleus formation and/or DNA damage after oral or dermal ex","page":31,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_004"}
SCCS_vision_codex NOAEL =250 mg/kg bw/day rat oral chronic carcinogenicity {"dose":"The NOAEL was established at 250 mg/kg bw/day.","effect":"nicity studies conducted with OPP and SOPP via the oral route identified the urinary bladder and kidneys as the main target tissues in mice and rats. A combined chronic toxicity/carcinogenicity study in B6C3F1 mice revealed that OPP induced tumours in liver and changes in kidney tubule morphology. The liver tumours observed in male mice were attributed to the high spontaneous occurrence of liver tumours in this specific mouse strain. The kidney changes included hypertrophy and increased relative kidney weight. The NOAEL was established at 250 mg/kg bw/day. In chronic toxicity/carcinogenicity in rats, kidney effects such as hyperplasia, cysts, infarct, acute inflammation, and papilla mineralisation of the kidney were observed. Further, neoplastic changes related to urinary bladder such as increased incidences of transitional cell carcinomas, papilloma, and increased incidence of calculi, congestion, haemorrhage mineralization and necrosis in the urinary bladder were observed. Based on the above effects, the NOAEL of 39 mg/kg bw/da","page":35,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_005"}
SCCS_vision_codex NOAEL =39 mg/kg bw/day rat - chronic carcinogenicity {"dose":"The NOAEL was established at 250 mg/kg bw/day.","effect":"idney weight. The NOAEL was established at 250 mg/kg bw/day. In chronic toxicity/carcinogenicity in rats, kidney effects such as hyperplasia, cysts, infarct, acute inflammation, and papilla mineralisation of the kidney were observed. Further, neoplastic changes related to urinary bladder such as increased incidences of transitional cell carcinomas, papilloma, and increased incidence of calculi, congestion, haemorrhage mineralization and necrosis in the urinary bladder were observed. Based on the above effects, the NOAEL of 39 mg/kg bw/day was established. In another combined chronic and carcinogenicity study, rats exhibited an increased incidence of hepatocellular adenoma with extensive renal damage characterised by tubular dilation and varying degrees of acute and chronic inflammation at 1000 mg/kg bw/day. Furthermore, a 91-week study in male F344 rats associated OPP treatment with the development of urinary bladder tumours, such as papilloma and carcinoma, primarily transitional cell papilloma and carcinoma at and above 531 mg/","page":35,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_006"}
SCCS_vision_codex NOAEL =95 mg/kg bw/day rat dermal 2- year carcinogenicity {"dose":"The LOAEL for the first study was established at 224 mg/kg bw/day based on the increased incidence of focal atrophy of pancreas in females and the NOAEL was established at 95 mg/kg bw/day.","effect":"a 2- year carcinogenicity study (conducted in 2 parts) in F344 rats, SOPP induced kidney tumours and increased incidences of interstitial nephritis of the kidney and increased incidences of focal atrophy of pancreatic acinar cells in females. Additionally, there was an increased incidence of urinary bladder tumours, including transitional cell papillomas and carcinomas. The LOAEL for the first study was established at 224 mg/kg bw/day based on the increased incidence of focal atrophy of pancreas in females and the NOAEL was established at 95 mg/kg bw/day. In a 112-week study in F344 male rats, transitional cell carcinoma was observed in rats at and above 1500 mg/kg bw/day. In a 102-week dermal carcinogenicity study in Swiss CD-1 mice, OPP did not induce skin neoplasms. In a 52-week, two-stage mouse skin carcinogenesis study in female CD-1 mice, SOPP induced epidermal proliferation and can act as a promoter but not as an initiator or a complete carcinogen. Overall, OPP and SOPP did not induce tumours when applied dermally. However","page":35,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_008"}
SCCS_vision_codex NOAEL =49 mg/kg bw/day rat oral 13 weeks carcinogenicity {"dose":"ssation of 13 weeks of exposure to OPP) • Sex and species- and strain-specific differences (OPP-induced bladder tumours were not observed in female rats, mice, dogs) • dermal application to mice does not affect tumour incidence in skin • no skin tumour development induced by OPP metabolites • tumours occur at high doses when sulfate and glucuron...","effect":"ssation of 13 weeks of exposure to OPP) • Sex and species- and strain-specific differences (OPP-induced bladder tumours were not observed in female rats, mice, dogs) • dermal application to mice does not affect tumour incidence in skin • no skin tumour development induced by OPP metabolites • tumours occur at high doses when sulfate and glucuronide conjugation pathways are saturated The SCCS has noted the NOAELs proposed by the Applicant for OPP and SOPP for systemic toxicity and carcinogenicity (for OPP: lowest NOAEL established at 39 and 49 mg/kg bw/day in males and females, respectively; for SOPP, an oral LOAEL of 224 mg/kg bw/day from a 104-week carcinogenicity study in rats has been considered as most appropriate and conservative value for PoD derivation. The Applicant applied a composite uncertainty factor of 10 to account for the extrapolation from LOAEL to NOAEL and study data quality resulting in a corrected PoD of 22.4 mg/kg bw/day. The SCCS, however, stated in SCCS/1555/15 that the 104-week carcinogenicity study in r","page":37,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_009"}
SCCS_vision_codex NOAEL =22.4 mg/kg bw/day rat oral 104-week developmental toxicity {"dose":"ion pathways are saturated The SCCS has noted the NOAELs proposed by the Applicant for OPP and SOPP for systemic toxicity and carcinogenicity (for OPP: lowest NOAEL established at 39 and 49 mg/kg bw/day in males and females, respectively; for SOPP, an oral LOAEL of 224 mg/kg bw/day from a 104-week carcinogenicity study in rats has been considere...","effect":"ion pathways are saturated The SCCS has noted the NOAELs proposed by the Applicant for OPP and SOPP for systemic toxicity and carcinogenicity (for OPP: lowest NOAEL established at 39 and 49 mg/kg bw/day in males and females, respectively; for SOPP, an oral LOAEL of 224 mg/kg bw/day from a 104-week carcinogenicity study in rats has been considered as most appropriate and conservative value for PoD derivation. The Applicant applied a composite uncertainty factor of 10 to account for the extrapolation from LOAEL to NOAEL and study data quality resulting in a corrected PoD of 22.4 mg/kg bw/day. The SCCS, however, stated in SCCS/1555/15 that the 104-week carcinogenicity study in rats performed with SOPP was not performed according to currently accepted standards but that it can be used as supporting information. Therefore, the SCCS will use the NOAEL of 25 mg/kg bw/d obtained from a developmental toxicity study for MoS calculation of both OPP and SOPP. This value is supported by the Applicant’s corrected PoD for SOPP of 22.4 mg/kg","page":37,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_010"}
SCCS_vision_codex NOAEL =25 mg/kg bw/d rabbit oral developmental developmental toxicity {"dose":"ts) An aggregate value of 17.4 g/d (269 mg/kg bw/d) for the amount of cosmetics applied daily is taken for MoS calculation according to the SCCS's Notes of Guidance 12th revision.","effect":"ts) An aggregate value of 17.4 g/d (269 mg/kg bw/d) for the amount of cosmetics applied daily is taken for MoS calculation according to the SCCS's Notes of Guidance 12th revision. Absorption through the skin DAp (%) = 45 % Amount of cosmetic product applied daily A (g/d) = 14.54 g/d Concentration of ingredient in finished product C (%) = 0.15 % Typical body weight of human = 60 kg Systemic exposure dose (SED) = A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60 = 0.163 mg/kg bw/d No adverse observed effect level NOAEL = 25 mg/kg bw/d (oral developmental toxicity study, rabbit) No adjustment, 100 % oral absorption Margin of Safety adjusted NOAEL/SED = 153 OPP in rinse-off products An aggregate value of 0.54 g/d (8.3 mg/kg bw/d) for the amount of cosmetics applied daily is taken for MoS calculation, according to the SCCS's Notes of Guidance 12th revision. Absorption through the skin DAp (%) = 45 % Amount of cosmetic product applied daily A (g/d) = 0.54 g/d Concentration of ingredient in finished product C (%) = 0.2 % Typica","page":41,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_012"}
SCCS_vision_codex NOAEL =100 % rabbit oral developmental developmental toxicity {"dose":"Absorption through the skin DAp (%) = 45 % Amount of cosmetic product applied daily A (g/d) = 14.54 g/d Concentration of ingredient in finished product C (%) = 0.15 % Typical body weight of human = 60 kg Systemic exposure dose (SED) = A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60 = 0.163 mg/kg bw/d No adverse observed effect level NOAEL = 25...","effect":"ing to the SCCS's Notes of Guidance 12th revision. Absorption through the skin DAp (%) = 45 % Amount of cosmetic product applied daily A (g/d) = 14.54 g/d Concentration of ingredient in finished product C (%) = 0.15 % Typical body weight of human = 60 kg Systemic exposure dose (SED) = A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60 = 0.163 mg/kg bw/d No adverse observed effect level NOAEL = 25 mg/kg bw/d (oral developmental toxicity study, rabbit) No adjustment, 100 % oral absorption Margin of Safety adjusted NOAEL/SED = 153 OPP in rinse-off products An aggregate value of 0.54 g/d (8.3 mg/kg bw/d) for the amount of cosmetics applied daily is taken for MoS calculation, according to the SCCS's Notes of Guidance 12th revision. Absorption through the skin DAp (%) = 45 % Amount of cosmetic product applied daily A (g/d) = 0.54 g/d Concentration of ingredient in finished product C (%) = 0.2 % Typical body weight of human = 60 kg Systemic exposure dose (SED) = A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60 = 0.0081 mg/kg bw","page":41,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_013"}
SCCS_vision_codex NOAEL =10000 mg/kg bw/day rat oral Sub-acute repeated dose toxicity {"dose":"Repeated dose toxicity Oral repeated dose toxicity studies Study type, Species Doses Key findings NOAEL or LOAEL Reference#/ KL rating OPP Sub-acute studies 1-month dietary study in rats (strain not specified) (5 females/ group); no guideline 0, 2000, 3000, 4000, 5000 and 10000 mg/kg bw/day At 2000 mg/kg bw/day and slight growth retardation was...","effect":"SCCS/1669/24 Final version Opinion on the safety of Biphenyl-2-ol and Sodium 2-biphenylolate (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 65 9.4 ANNEX 4. Repeated dose toxicity Oral repeated dose toxicity studies Study type, Species Doses Key findings NOAEL or LOAEL Reference#/ KL rating OPP Sub-acute studies 1-month dietary study in rats (strain not specified) (5 females/ group); no guideline 0, 2000, 3000, 4000, 5000 and 10000 mg/kg bw/day At 2000 mg/kg bw/day and slight growth retardation was observed, all of the other dose groups lost weight rapidly. LOAEL: 2000 mg/kg bw/day Hodge et al., 1952 in (ECHA RAC, 2022)/KL2 32-day gavage study in male rats (15 males/ group); no guideline 0, 2, 20 and 200 mg/kg bw/day No treatment related adverse effects on any of parame","page":65,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_023"}
SCCS_vision_codex NOAEL =200 mg/kg bw/day rat oral Sub-acute repeated dose toxicity {"dose":"rating OPP Sub-acute studies 1-month dietary study in rats (strain not specified) (5 females/ group); no guideline 0, 2000, 3000, 4000, 5000 and 10000 mg/kg bw/day At 2000 mg/kg bw/day and slight growth retardation was observed, all of the other dose groups lost weight rapidly.","effect":"rating OPP Sub-acute studies 1-month dietary study in rats (strain not specified) (5 females/ group); no guideline 0, 2000, 3000, 4000, 5000 and 10000 mg/kg bw/day At 2000 mg/kg bw/day and slight growth retardation was observed, all of the other dose groups lost weight rapidly. LOAEL: 2000 mg/kg bw/day Hodge et al., 1952 in (ECHA RAC, 2022)/KL2 32-day gavage study in male rats (15 males/ group); no guideline 0, 2, 20 and 200 mg/kg bw/day No treatment related adverse effects on any of parameters at any dose level. NOAEL: 200 mg/kg bw/day Macintosh, 1945 in (ECHA RAC, 2022)/KL2 13-day gavage study in New Zealand rabbits (2 females/ dose); similar to OECD 407 0, 100, 500 and 1000 mg/kg bw/day At 1000 mg/kg bw/day, ↓ final body weight, ↓ in food consumption was observed. At 500 mg/kg bw/day, changes in body weight, food consumption, absolute/relative, kidney and liver weight were observed. At 100 mg/kg bw/day, ↓ absolute/relative, liver weight. NOAEL: 100 mg/kg bw/day (ECHA, 2023b; ECHA RAC, 2022)/KL2 4-week gavage study in Beagle","page":65,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_024"}
SCCS_vision_codex NOAEL =100 mg/kg bw/day rabbit oral 13-day NOAEL study {"dose":"w/day No treatment related adverse effects on any of parameters at any dose level.","effect":"w/day No treatment related adverse effects on any of parameters at any dose level. NOAEL: 200 mg/kg bw/day Macintosh, 1945 in (ECHA RAC, 2022)/KL2 13-day gavage study in New Zealand rabbits (2 females/ dose); similar to OECD 407 0, 100, 500 and 1000 mg/kg bw/day At 1000 mg/kg bw/day, ↓ final body weight, ↓ in food consumption was observed. At 500 mg/kg bw/day, changes in body weight, food consumption, absolute/relative, kidney and liver weight were observed. At 100 mg/kg bw/day, ↓ absolute/relative, liver weight. NOAEL: 100 mg/kg bw/day (ECHA, 2023b; ECHA RAC, 2022)/KL2 4-week gavage study in Beagle dogs (2/sex/dose); no guideline 0, 100, 200, 300 (400 mg up to Day 5, lowered to 300 due to emesis) mg/kg bw/day 5 days/week for 4 weeks At 300 mg/kg bw/day, ↓ RBC, Hb, HCT and platelet was observed. At 200 mg/kg bw/day, dose-related emesis in all dogs, ↓ RBC and HCT count was observed. NOAEL: 100 mg/kg bw/day Cosse et al. in (EC, 2023; ECHA RAC, 2022)/KL2","page":65,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_025"}
SCCS_vision_codex NOAEL =2.5 % rat oral Sub-chronic repeated dose toxicity {"dose":"90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 66 Study type, Species Doses Key findings NOAEL or LOAEL Reference#/ KL rating Sub-chronic studie...","effect":"SCCS/1669/24 Final version Opinion on the safety of Biphenyl-2-ol and Sodium 2-biphenylolate (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 66 Study type, Species Doses Key findings NOAEL or LOAEL Reference#/ KL rating Sub-chronic studies 13-week dietary study in F344/DuCrj Rats (10/sex/group); similar to OECD TG 408 0, 0.156, 0.313, 0.625, 1.25, and 2.5% OPP equivalent to 0, 182, 391, 761, 1669, and 2798 mg/kg bw/day in males and 0, 202, 411, 803, 1650, and 3014 mg/kg bw/day in females At 2798/3014 mg/kg bw/day, ↓ body weight, terminal body weight, food and water consumption, changes in organ weight, and histopathological changes in the kidney and bladder, and ↓ Red Blood Count (RBC), Haemoglobin","page":66,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_027"}
SCCS_vision_codex NOAEL =761 mg/kg bw/day rat oral 3 months NOAEL study {"dose":"At 1669/1650 mg/kg bw/day, ↓ body weight, food, and water consumption, ↓Hb and MCH level and ↑ relative liver weight, relative kidney weight, absolute bladder weight and abnormal growth in the bladder mucosa was observed.","effect":"gical changes in the kidney and bladder, and ↓ Red Blood Count (RBC), Haemoglobin (Hb), Mean Corpuscular Volume (MCV), Mean Corpuscular Haemoglobin (MCH) and Mean Corpuscular Haemoglobin Concentration (MCHC) was observed. At 1669/1650 mg/kg bw/day, ↓ body weight, food, and water consumption, ↓Hb and MCH level and ↑ relative liver weight, relative kidney weight, absolute bladder weight and abnormal growth in the bladder mucosa was observed. At 761/ 803 mg/kg bw/day, changes in liver and kidney weight were observed. NOAEL: 761 mg/kg bw/day Iguchi et al., 1984 in (EC, 2023; ECHA, 2023b; ECHA RAC, 2022)/KL2 3 months dietary study (strain not specified) in rats (12/sex/group); no guideline 0, 100, 300, 1000 and 2000 mg/kg bw/day At 2000 mg/kg bw/day, slight growth retardation, ↑ liver, kidney and. in some rats (no numerical data available) At 1000 mg/kg bw/day, ↑ liver, kidney, and spleen weight in some rats (no numerical data available). NOAEL: 1000 mg/kg bw/day Hodge et al., 1952 in (ECHA RAC, 2022)/KL4 6 months gavage study (strain","page":66,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_028"}
SCCS_vision_codex NOAEL =1000 mg/kg bw/day rat oral 3 months NOAEL study {"dose":"At 761/ 803 mg/kg bw/day, changes in liver and kidney weight were observed.","effect":"a was observed. At 761/ 803 mg/kg bw/day, changes in liver and kidney weight were observed. NOAEL: 761 mg/kg bw/day Iguchi et al., 1984 in (EC, 2023; ECHA, 2023b; ECHA RAC, 2022)/KL2 3 months dietary study (strain not specified) in rats (12/sex/group); no guideline 0, 100, 300, 1000 and 2000 mg/kg bw/day At 2000 mg/kg bw/day, slight growth retardation, ↑ liver, kidney and. in some rats (no numerical data available) At 1000 mg/kg bw/day, ↑ liver, kidney, and spleen weight in some rats (no numerical data available). NOAEL: 1000 mg/kg bw/day Hodge et al., 1952 in (ECHA RAC, 2022)/KL4 6 months gavage study (strain not specified) in rats 0, 50, 100, 200 and 500 mg/kg bw/day 5 days/week At 500 mg/kg bw/day ↑ liver and kidney NOAEL: 200 mg/kg bw/day Hodge et al., 1952 in (ECHA, 2023b;","page":66,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_029"}
SCCS_vision_codex NOAEL =500 mg/kg bw/day dog oral Chronic NOAEL study {"dose":"Similar to OECD TG 409 0, 20, 200, and 500 mg/kg bw/day At 500 mg/kg bw/day, ↑ kidney weight in males (no numerical data) was observed.","effect":"SCCS/1669/24 Final version Opinion on the safety of Biphenyl-2-ol and Sodium 2-biphenylolate (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 67 Study type, Species Doses Key findings NOAEL or LOAEL Reference#/ KL rating (12/sex/group); no guideline weight (no numerical data available). ECHA RAC, 2022) /KL4 Chronic studies 1-year dietary study (strain not specified) in dogs (1- 2/sex/group); Similar to OECD TG 409 0, 20, 200, and 500 mg/kg bw/day At 500 mg/kg bw/day, ↑ kidney weight in males (no numerical data) was observed. NOAEL: 200 mg/kg bw/day Hodge et al., 1952 in (EC, 2023; ECHA, 2023b; ECHA RAC, 2022)/KL2 1 year gavage study in Beagle dogs (4/sex/group); Similar to OECD TG 409 0, 30, 100, and","page":67,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_031"}
SCCS_vision_codex NOAEL =4294 mg/kg bw/day mouse oral Sub-chronic repeated dose toxicity {"dose":"g bw/day) At 2000 mg/kg bw/day, an ↑ in dark- stained cells and a few mitoses were observed.","effect":"g bw/day) At 2000 mg/kg bw/day, an ↑ in dark- stained cells and a few mitoses were observed. The authors suggest that these changes are the prodromal stage of the tumours induced by SOPP after longer treatment periods. Only bladder examined (once/week by transmission electron microscopy (TEM). LOAEL: 2000 mg/kg bw/day Fukumori et al. in (SCCS, 2015)/KL2 Sub-chronic studies 13-week dietary study in B6C3F1 mice 0, 0.25, 0.5, 1.0, 2.0 and 4.0% (correspond- ding to At 5375/6349 mg/kg bw/day, ↓ body weight, ↓ mean food NOAEL: 3529 and 4294 mg/kg bw/day for males Shibata et al., 1981, 1985 in (SCCS, 2015)/KL2","page":67,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_035"}
SCCS_vision_codex NOAEL =5375 mg/kg bw/day rat oral 13-week NOAEL study {"dose":"90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 68 Study type, Species Doses Key findings NOAEL or LOAEL Reference#/ KL rating (10/sex/group); no...","effect":"SCCS/1669/24 Final version Opinion on the safety of Biphenyl-2-ol and Sodium 2-biphenylolate (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 68 Study type, Species Doses Key findings NOAEL or LOAEL Reference#/ KL rating (10/sex/group); no guideline weighted average doses of 0, 451, 902, 1581, 3529 and 5375 mg/kg bw/day in males and 0, 488, 976, 1926, 4294 and 6349 mg/kg bw/day in females, respectively) intake, ↑ urinary pH value and ↓ urine density. and females, respectively 13-week dietary study in F344 rats (10/sex/group); no guideline 0, 0.125, 0.25, 0.5, 1, 2 and 4% (corresponding to 0, 85, 177, 353, 706, 1384 and 2487 in males and 0, 87, 177, 352, 694, 1338 and 2431 mg/kg bw/day in females, res","page":68,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_036"}
SCCS_vision_codex NOAEL =353 mg/kg bw/day rat oral 13-week NOAEL study {"dose":"les, respectively) intake, ↑ urinary pH value and ↓ urine density. and females, respectively 13-week dietary study in F344 rats (10/sex/group); no guideline 0, 0.125, 0.25, 0.5, 1, 2 and 4% (corresponding to 0, 85, 177, 353, 706, 1384 and 2487 in males and 0, 87, 177, 352, 694, 1338 and 2431 mg/kg bw/day in females, respectively) At 2431/2487 mg...","effect":"les, respectively) intake, ↑ urinary pH value and ↓ urine density. and females, respectively 13-week dietary study in F344 rats (10/sex/group); no guideline 0, 0.125, 0.25, 0.5, 1, 2 and 4% (corresponding to 0, 85, 177, 353, 706, 1384 and 2487 in males and 0, 87, 177, 352, 694, 1338 and 2431 mg/kg bw/day in females, respectively) At 2431/2487 mg/kg bw/day, ↓ body weight, moderate pyelonephritis was observed. At 1338/1384 mg/kg bw/day, ↓ body weight was observed. At 694/706 mg/kg bw/day, ↓ body weight was observed. NOAEL: 353 mg/kg bw/day Iguchi et al., 1979 in (SCCS, 2015)/KL2 13-week dietary study in F344 rats (20/sex/group); no guideline 0, 0.625, 1.25, and 2.5% (correspond- ding to weighted average doses of 0, 625 1250 and 2500 in males and 0, 706, 1411 and 2823 mg/kg bw/day in females, respectively) At 2500/2823 mg/kg bw/day, ↓ body weight gain was observed. At 1250/1411 mg/kg bw/day, ↓ body weight gain was observed. NOAEL: 625 mg/kg bw/day Nakamura et al., 1981 in (SCCS, 2015)/KL2 90-day dietary study in male F344 rats (grou","page":68,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_037"}
SCCS_vision_codex NOAEL =625 mg/kg bw/day rat oral 13-week NOAEL study {"dose":"1338/1384 mg/kg bw/day, ↓ body weight was observed.","effect":"1338/1384 mg/kg bw/day, ↓ body weight was observed. At 694/706 mg/kg bw/day, ↓ body weight was observed. NOAEL: 353 mg/kg bw/day Iguchi et al., 1979 in (SCCS, 2015)/KL2 13-week dietary study in F344 rats (20/sex/group); no guideline 0, 0.625, 1.25, and 2.5% (correspond- ding to weighted average doses of 0, 625 1250 and 2500 in males and 0, 706, 1411 and 2823 mg/kg bw/day in females, respectively) At 2500/2823 mg/kg bw/day, ↓ body weight gain was observed. At 1250/1411 mg/kg bw/day, ↓ body weight gain was observed. NOAEL: 625 mg/kg bw/day Nakamura et al., 1981 in (SCCS, 2015)/KL2 90-day dietary study in male F344 rats (group not specified); no guideline 0 and 2% (correspond- ding to weighted average doses of 2000 mg/kg bw/day) At 2000 mg/kg bw/day, ↑ thickness of the bladder epithelium from Day 14 until end of study (classified as hyperplasia with accompanying increased frequency of cell infiltration) was observed. LOAEL: 2000 mg/kg bw/day Reitz et al., 1983 in (SCCS, 2015)/KL2","page":68,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_038"}
SCCS_vision_codex NOAEL =1865 mg/kg bw/day mouse dermal 4-week repeated dose toxicity {"dose":"90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 69 Dermal repeated dose toxicity studies Study type, Species Doses Key findings NOAEL or LOAEL Re...","effect":"SCCS/1669/24 Final version Opinion on the safety of Biphenyl-2-ol and Sodium 2-biphenylolate (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 69 Dermal repeated dose toxicity studies Study type, Species Doses Key findings NOAEL or LOAEL Reference#/ KL rating OPP 4-week dermal toxicity study in Swiss Webster CFW mice (10/sex/group); no guideline 0, 5.95, 11.4, 20.8, 35.7 and 55.5 mg / 0.1 mL acetone (corresponding to weighted average doses of 0, 383.1, 699.08, 1200 and 1865 mg/kg bw/day for males 0, 460.21, 839.70, 1441.20 and 2240.53 mg/kg bw/day for females respectively) 3 days/week Ulcerative lesions at the site of application were observed in all mice that received ≤20.8 mg; in 6/10 males and 9/10 females that received 11.4 mg; in 2/1","page":69,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_039"}
SCCS_vision_codex NOAEL =490 mg/kg bw/day rat oral - reproductive toxicity {"dose":"0, 40, 140 and 490 mg/kg bw/day Actual:","effect":"SCCS/1669/24 Final version Opinion on the safety of Biphenyl-2-ol and Sodium 2-biphenylolate (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 70 9.5 ANNEX 5. Reproductive and development toxicity Overview of reproductive toxicity studies Study type, Species Doses Critical effects NOAEL or LOAEL Reference#/ KL rating OPP Two- generation dietary reproductive toxicity study, CD Sprague- Dawley rats, (32-35/sex group) OECD TG 416 Nominal: 0, 40, 140 and 490 mg/kg bw/day Actual: 0, 35, 125 and 457 mg/kg bw/day for 2 generations Parental effects At 457 mg/kg bw/day, ↓ body weight, body weight gain and terminal body weight in males and females, ↑ relative weight of ovaries in females, ↑ Incidence of renal calculi and haemorrhage in males. ↑ Incidence of bladder calculi and urinary bladder transitional","page":70,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_042"}
SCCS_vision_codex NOAEL =35 mg/kg bw/day - - - reproductive toxicity {"dose":"ght of testes and kidney in males, ↑ Incidence of urinary bladder transitional cell hyperplasia in males At 125 mg/kg bw/day Parental effects ↑ in body weight gain and changes in food consumptions, ↑ relative weight of ovaries in females, ↑ Incidence of average number cells/layer in females and ↑ Incidence of bladder calculi in males were observed.","effect":"ght of testes and kidney in males, ↑ Incidence of urinary bladder transitional cell hyperplasia in males At 125 mg/kg bw/day Parental effects ↑ in body weight gain and changes in food consumptions, ↑ relative weight of ovaries in females, ↑ Incidence of average number cells/layer in females and ↑ Incidence of bladder calculi in males were observed. F1 effects ↑ Absolute weight of liver and kidney and testes in males, ↓ incidence of average number of cells/layers of urinary bladder were observed. At 35 mg/kg bw/day NOAEL (systemic toxicity): 35 mg/kg bw/day NOAEL (reproductive toxicity): 457 mg/kg bw/day NOAEL (offspring toxicity): 125 mg/kg bw/day Eigenberg et al., 1990 in (ECHA RAC, 2022; ECHA, 2023b; SCCS, 2015)/KL2","page":70,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_043"}
SCCS_vision_codex NOAEL =457 mg/kg bw/day - - - reproductive toxicity {"dose":"asia in males At 125 mg/kg bw/day Parental effects ↑ in body weight gain and changes in food consumptions, ↑ relative weight of ovaries in females, ↑ Incidence of average number cells/layer in females and ↑ Incidence of bladder calculi in males were observed.","effect":"asia in males At 125 mg/kg bw/day Parental effects ↑ in body weight gain and changes in food consumptions, ↑ relative weight of ovaries in females, ↑ Incidence of average number cells/layer in females and ↑ Incidence of bladder calculi in males were observed. F1 effects ↑ Absolute weight of liver and kidney and testes in males, ↓ incidence of average number of cells/layers of urinary bladder were observed. At 35 mg/kg bw/day NOAEL (systemic toxicity): 35 mg/kg bw/day NOAEL (reproductive toxicity): 457 mg/kg bw/day NOAEL (offspring toxicity): 125 mg/kg bw/day Eigenberg et al., 1990 in (ECHA RAC, 2022; ECHA, 2023b; SCCS, 2015)/KL2","page":70,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_045"}
SCCS_vision_codex NOAEL =92 mg/kg bw/day rat - chronic reproductive toxicity {"dose":"0, 20, 100 and 500 mg/kg bw/day Actual:","effect":"wley rats, (30/sex/group ) OECD TG 416 Nominal: 0, 20, 100 and 500 mg/kg bw/day Actual: 18/17, 93/92 and 459/457 mg/kg bw/day for males and females, respectively Parental effects At 459/457 mg/kg bw/day, no treatment-related increase in mortality, changes in body weight and terminal body weight, ↓ food consumption in males and females, ↑ incidence of histopathological alterations in males: in the urinary bladder; chronic Inflammation, nodular/papillary; simple hyperplasia, and the ureter dilatation and hyperplasia NOAEL (systemic and offspring toxicity): 92 mg/kg bw/day NOAEL (reproductive toxicity): 457 mg/kg bw/day Eigenberg and Lake 1995 in (ECHA RAC, 2022; ECHA, 2023b; SCCS, 2015)/KL1","page":71,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_047"}
SCCS_vision_codex NOAEL =2100 mg/kg bw/day mouse oral Developmental reproductive toxicity {"dose":"At 93/92 mg/kg bw/day, no statistically significant treatment related effects were observed in Parents and F1 Reproductive parameters At 459/457 mg/kg bw/day, Parents, F1 and F2 - ↑ fertility index during F2b generation, ↑ food consumption during gestation was observed However, this increase in the fertility index is considered an artifact due t...","effect":"ia, and kidney debris were observed. At 93/92 mg/kg bw/day, no statistically significant treatment related effects were observed in Parents and F1 Reproductive parameters At 459/457 mg/kg bw/day, Parents, F1 and F2 - ↑ fertility index during F2b generation, ↑ food consumption during gestation was observed However, this increase in the fertility index is considered an artifact due to the extremely low fertility index for the control group. Developmental toxicity studies Study type, Species Doses Critical effects NOAEL or LOAEL Reference#/ KL rating OPP Prenatal developmental toxicity via gavage in JCL- ICR mice, (21 females/group), similar to OCED TG 414 0, 1450, 1740 and 2100 mg/kg bw/day, GD 7-15 Maternal toxicity At 2100 mg/kg bw/day, ↑ mortality: 5 mice died on GD 8, 7 on GD 9 and 2 each on GD 11 and 12, ↓ body weight/body weight gain and ↓ in absolute/relative heart weight were observed. At 1740 mg/kg bw/day, ↑ LOAEL (maternal and developmental toxicity): 1450 mg/kg bw/day Ogata et al., 1978 in (EC, 2023; ECHA, 2023b; ECHA","page":72,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_050"}
SCCS_vision_codex NOAEL =1450 mg/kg bw/day mouse - - reproductive toxicity {"dose":"At 1450 mg/kg bw/day, ↑ mortality:","effect":"SCCS/1669/24 Final version Opinion on the safety of Biphenyl-2-ol and Sodium 2-biphenylolate (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 73 Study type, Species Doses Critical effects NOAEL or LOAEL Reference#/ KL rating mortality: 4 mice died on GD 7 and 1 each on GD 14, GD 15, and GD 16, ↓ body weight/body weight gain (no numerical data available), ↓ in absolute/relative heart weight and ↑ in relative liver weight. At 1450 mg/kg bw/day, ↑ mortality: 1 mouse died each on GD 11 and 15, 2 mice died on GD 16. ↑ in absolute/relative liver weight. Litter/reproductive data At 2100 mg/kg bw/day, ↓ foetal bodyweight, ↑ frequency of foetuses with cervical ribs, ↓ mean number of ossified left/right phalanges","page":73,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_051"}
SCCS_vision_codex NOAEL =300 mg/kg bw/day rat oral Prenatal developmental toxicity {"dose":"Prenatal developmental toxicity via gavage in SD rat, (25-35 females/group), similar to OCED TG 414 0, 100, 300 and 700 mg/kg bw/day, GD 6-15 Maternal toxicity At 700 mg/kg bw/day, ↓ body weight, body weight gain and absolute liver wight was observed.","effect":"↓ foetal body weight, ↑ frequency of foetuses with cervical ribs, ↓ mean number of ossified left/right phalanges in hindlegs, ↑ frequency of foetuses with externally visible malformations. Prenatal developmental toxicity via gavage in SD rat, (25-35 females/group), similar to OCED TG 414 0, 100, 300 and 700 mg/kg bw/day, GD 6-15 Maternal toxicity At 700 mg/kg bw/day, ↓ body weight, body weight gain and absolute liver wight was observed. At 300 mg/kg bw/day, decreased weight gain (not statistically significant) and NOAEL (maternal and evelopmental): 300 mg/kg bw/day (whereas SCCS has derived maternal NOAEL at 150 mg/kg bw/day) John et al., 1978 in (ECHA, 2023b)/KL2","page":73,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_052"}
SCCS_vision_codex NOAEL =150 mg/kg bw/day rat oral Prenatal developmental toxicity {"dose":"Prenatal developmental toxicity via gavage in SD rat, (25-35 females/group), similar to OCED TG 414 0, 100, 300 and 700 mg/kg bw/day, GD 6-15 Maternal toxicity At 700 mg/kg bw/day, ↓ body weight, body weight gain and absolute liver wight was observed.","effect":"fied left/right phalanges in hindlegs, ↑ frequency of foetuses with externally visible malformations. Prenatal developmental toxicity via gavage in SD rat, (25-35 females/group), similar to OCED TG 414 0, 100, 300 and 700 mg/kg bw/day, GD 6-15 Maternal toxicity At 700 mg/kg bw/day, ↓ body weight, body weight gain and absolute liver wight was observed. At 300 mg/kg bw/day, decreased weight gain (not statistically significant) and NOAEL (maternal and evelopmental): 300 mg/kg bw/day (whereas SCCS has derived maternal NOAEL at 150 mg/kg bw/day) John et al., 1978 in (ECHA, 2023b)/KL2","page":73,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_053"}
SCCS_vision_codex NOAEL =700 mg/kg bw/day rat oral Developmental developmental toxicity {"dose":"Developmental toxicity At 700 mg/kg bw/day, ↑Incidence of post- implantation loss in foetuses and litters were observed.","effect":"SCCS/1669/24 Final version Opinion on the safety of Biphenyl-2-ol and Sodium 2-biphenylolate (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 74 Study type, Species Doses Critical effects NOAEL or LOAEL Reference#/ KL rating reduced food consumption was observed. Developmental toxicity At 700 mg/kg bw/day, ↑Incidence of post- implantation loss in foetuses and litters were observed. Skeletal alteration: ↑Incidence foetuses with: Delayed ossification of sternebrae foetuses, skull foramen, skull bone island Prenatal developmental toxicity via gavage in Wistar rats, (11-20 females/group), similar to OCED TG 414 0, 150, 300, 600 and 1200 mg/kg bw/day, GD 6-15 Maternal toxicity At 1200 mg/kg bw/day, 10/11 dams","page":74,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_054"}
SCCS_vision_codex NOAEL =600 mg/kg bw/day rat oral Developmental developmental toxicity {"dose":"At 600 mg/kg bw/day, ↓ body weight gain, clinical signs such as pregnant rats fell into ataxia for several hours.","effect":"xia for several hours. At 600 mg/kg bw/day, ↓ body weight gain, clinical signs such as pregnant rats fell into ataxia for several hours. At 300 mg/kg bw/day, ↓ body weight gain, clinical signs such as pregnant rats fell into ataxia for several hours. Developmental toxicity At 600 mg/kg bw/day, ↑ percentage of foetal death, ↓ mean foetal weight, ↑ foetal incidence of malformations. At 300 mg/kg bw/day, ↑ foetal incidence of malformations NOAEL (maternal and developmental): 150 mg/kg bw/day Note: SCCS considered the NOAEL for developmental at 600 mg/kg bw/day) Kaneda et al., 1978 in (ECHA, 2023b; ECHA RAC, 2022; SCCS, 2015)/KL2 Range finding Prenatal developmental toxicity via gavage in New Zealand rabbits, (7 females/ group), no guideline 0, 250, 500 and 750 mg/ kg bw/day GD 7-19 Maternal toxicity At 750 mg/kg bw/day, mortality: nine rabbits died prior to study termination. Two rabbits (one at 500 and one at 750 mg/kg bw/day) were found withdepositions of the test material in the lungs. The remaining deaths were considered treatme","page":74,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_056"}
SCCS_vision_codex NOAEL =400 mg/ kg bw/ day mouse oral Prenatal developmental toxicity {"dose":"90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 76 Study type, Species Doses Critical effects NOAEL or LOAEL Reference#/ KL rating SOPP Prenatal...","effect":"SCCS/1669/24 Final version Opinion on the safety of Biphenyl-2-ol and Sodium 2-biphenylolate (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 76 Study type, Species Doses Critical effects NOAEL or LOAEL Reference#/ KL rating SOPP Prenatal developmental toxicity via gavage in JCL- ICR mice, (20 females/group), similar to OCED TG 414 0, 100, 200 and 400 mg/ kg bw/ day, GD 7-15 Maternal toxicity At 400 mg/kg bw/day, ↑ mortality (80% of unscheduled deaths), ↓ body weight and body weight gain, ↓ absolute weight of liver, heart, and spleen. At 200 mg/kg bw/day, ↑ mortality (20% of unscheduled deaths), ↓ body weight and body weight gain, ↑ relative lung weight at 100 mg/kg bw/day, ↓ body weight and body wei","page":76,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_061"}
SCCS_vision_codex NOAEL =269 mg/kg bw/day rat - 2-year carcinogenicity {"dose":"At 531 mg/kg bw/day, haematuria, ↓body weights, proliferative lesions in the urinary bladder, and moderate to severe nephritic lesions and urinary bladder tumours (papilloma and carcinoma, mainly transitional cell papilloma and carcinoma) were observed.","effect":"/day, ↑white blood cell count, haematuria, ↓body weights, proliferative lesions in the urinary bladder, and moderate to severe nephritic lesions and urinary bladder tumours (papilloma and carcinoma, mainly transitional cell papilloma and carcinoma). were observed. At 531 mg/kg bw/day, haematuria, ↓body weights, proliferative lesions in the urinary bladder, and moderate to severe nephritic lesions and urinary bladder tumours (papilloma and carcinoma, mainly transitional cell papilloma and carcinoma) were observed. NOAEL (carcinogenicity): 269 mg/kg bw/day Hiraga K., and Fujii T. 1984 in (EC, 2023; ECHA, 2023b; ECHA RAC, 2022; SCCS, 2015)/KL2 2-year combined chronic toxicity/ carcinogenicity study in CDF[F344]/BR rats 0, 800, 4000 and 8000/ 10000 ppm (equivalent to 0, 39/49, 200/248 and 402/647 mg/kg bw/day in At 402/647 mg/kg bw/day, ↑ incidence of urinary bladder masses, ↑ incidence of pitted zones in kidneys. Neoplastic changes such as ↑ incidence of transitional NOAEL (carcinogenicity and systemic toxicity): 39 and 49 mg/kg bw","page":93,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_067"}
SCCS_vision_codex NOAEL =248 mg/kg bw/day - - - NOAEL study {"dose":"At 200/248 mg/kg bw/day, neoplastic changes in the urinary bladder, such as ↑ incidence of transitional cell carcinomas in males, ↓ body weight, body weight gain, food consumption and food efficiency, ↑clinical signs and gross pathological signs of toxicity. and females, respectively SCCS, 2015;","effect":"SCCS/1669/24 Final version Opinion on the safety of Biphenyl-2-ol and Sodium 2-biphenylolate (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 94 Study type, Species Doses Key findings NOAEL/ LOAEL Reference / KL rating (50/sex/group); OECD TG 453 males/females, respectively cell carcinomas, ↑ incidence of papillomas in males was observed. Non-neoplastic changes in the urinary bladder and kidney were observed. At 200/248 mg/kg bw/day, neoplastic changes in the urinary bladder, such as ↑ incidence of transitional cell carcinomas in males, ↓ body weight, body weight gain, food consumption and food efficiency, ↑clinical signs and gross pathological signs of toxicity. and females, respectively SCCS, 2015;","page":94,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_069"}
SCCS_vision_codex NOAEL =3081 mg/kg bw/day - oral 96-week NOAEL study {"dose":"Systemically, slightly increased incidences of dilatation of the kidney tubules compared to acetone controls were observed in OPP treated animals.","effect":"effect. Systemically, slightly increased incidences of dilatation of the kidney tubules compared to acetone controls were observed in OPP treated animals. In males, a greater incidence of focal necrosis of the liver (of mild degree) was observed. OPP, alone or after tumour initiation with DMBA, did not increase the incidence of neoplastic skin lesions when applied dermally over two years National Toxicology Program, 1986 in (SCCS, 2015)/KL2 SOPP Oral 96-week dietary 0, 0.5, 1.0 and 2.0% At 3009/3081 mg/kg bw/day, NOAEL Hagiwara et","page":94,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_071"}
SCCS_vision_codex NOAEL =3009 mg/kg bw/day mouse - - NOAEL study {"dose":"90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 95 Study type, Species Doses Key findings NOAEL/ LOAEL Reference / KL rating study in B6C3F1 mice...","effect":"SCCS/1669/24 Final version Opinion on the safety of Biphenyl-2-ol and Sodium 2-biphenylolate (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 95 Study type, Species Doses Key findings NOAEL/ LOAEL Reference / KL rating study in B6C3F1 mice (50/sex/group); no guideline equivalent to 0, 591, 1451, and 3009 mg/kg bw/day for the males and 0, 480, 1464, and 3081 mg/kg bw/day for the females, respectively ↑hepatocellular carcinomas and calcification of the brain were observed. At 1451/1464 mg/kg bw/day ↑ haemangiosarcomas of the liver, ↑hepatocellular carcinomas were observed. At 480 mg/kg bw/day, cystic endometrial hyperplasia of the uterus in females was observed in females. Authors considered increased","page":95,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_072"}
SCCS_vision_codex NOAEL =125 mg/kg bw/day - oral 2-year carcinogenicity {"dose":"no guideline 0, 0.125, 0.25, 0.5, 1.0, 2.0 and 4.0% equivalent to 0, 62, 125, 250, 500, 1000 and 2000 mg/kg bw/dayk At 2000 mg/kg bw/day, ↑incidence of carcinoma in the renal papilla was observed.","effect":"no guideline 0, 0.125, 0.25, 0.5, 1.0, 2.0 and 4.0% equivalent to 0, 62, 125, 250, 500, 1000 and 2000 mg/kg bw/dayk At 2000 mg/kg bw/day, ↑incidence of carcinoma in the renal papilla was observed. At 1000 mg/kg bw/day, ↑ in the incidence of tumours of the urinary system and carcinosarcoma was observed. At 500 mg/kg bw/day, ↑in the incidence of tumours of the urinary system was observed. At 250 mg/kg bw/day, ↑in the incidence of tumours of the urinary system was observed. Haematuria was observed at all dose levels. NOAEL (carcinogenicity): 125 mg/kg bw/day LOAEL (systemic toxicity): 62 mg/kg bw/day Hiraga et al..., 1981 in (SCCS, 2015)/KL2 2-year dietary carcinogenicity 1st study: Males: 0, 7000 and 20000 ppm, At 466/770 mg/kg bw/day, ↑ focal atrophy of the LOAEL (carcinogenicity Hiraga et al..., 1983 in (SCCS,","page":95,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_073"}
SCCS_vision_codex NOAEL =770 mg/kg bw/day rat - - NOAEL study {"dose":"90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 96 Study type, Species Doses Key findings NOAEL/ LOAEL Reference / KL rating study in F344 rats (...","effect":"SCCS/1669/24 Final version Opinion on the safety of Biphenyl-2-ol and Sodium 2-biphenylolate (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 96 Study type, Species Doses Key findings NOAEL/ LOAEL Reference / KL rating study in F344 rats (50/sex/group); no guideline equivalent to 0, 270 and 770 mg/kg bw/day, respectively) and Females: 0, 5000 and 10000 ppm equivalent to 0, 224 and 466 mg/kg bw/day, respectively pancreas and ↑ incidences of interstitial nephritis of the kidney were observed. At 466/770 mg/kg bw/day in the kidneys, both non- neoplastic changes (interstitial nephritis and pyelonephritis) and neoplastic changes (transitional cell papilloma and carcinoma) occurred in low incidences in the","page":96,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_074"}
SCCS_vision_codex NOAEL =395 mg/kg bw/day rat - 2-year carcinogenicity {"dose":"95 mg/kg bw/day 2-year carcinogenicity study in male F344 rats (groups not specified); no guideline 0, 0.25, 0.5, 1.0 and 2.0% equivalent to approximately 0, 197, 395, 780 and 1579 mg/kg bw/dayl At 1579 mg/kg bw/day, hyperplasia of bladder was observed.","effect":"kidney, urinary bladder papillomas and/or carcinomas were observed. NOAEL (carcinogenicity and systemic toxicity): 95 mg/kg bw/day 2-year carcinogenicity study in male F344 rats (groups not specified); no guideline 0, 0.25, 0.5, 1.0 and 2.0% equivalent to approximately 0, 197, 395, 780 and 1579 mg/kg bw/dayl At 1579 mg/kg bw/day, hyperplasia of bladder was observed. Development of papilloma and carcinoma was observed after 36 weeks. At 780 mg/kg bw/day, development of simple hyperplasia from week 36 was observed. NOAEL (carcinogenicity and systemic toxicity): 395 mg/kg bw/day Fukushima et al..., 1982 in (SCCS, 2015)/KL4 112-week carcinogenicity 0, 2500, 5000, 10000, 15000 and 20000 ppm At 1500 mg/kg bw/day, transitional cell carcinoma NOAEL (carcinogenicity Niho et al..., 2002 in (SCCS,","page":96,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_076"}
SCCS_vision_codex NOAEL =1500 mg/kg bw/day - - 36 weeks carcinogenicity {"dose":".5, 1.0 and 2.0% equivalent to approximately 0, 197, 395, 780 and 1579 mg/kg bw/dayl At 1579 mg/kg bw/day, hyperplasia of bladder was observed.","effect":".5, 1.0 and 2.0% equivalent to approximately 0, 197, 395, 780 and 1579 mg/kg bw/dayl At 1579 mg/kg bw/day, hyperplasia of bladder was observed. Development of papilloma and carcinoma was observed after 36 weeks. At 780 mg/kg bw/day, development of simple hyperplasia from week 36 was observed. NOAEL (carcinogenicity and systemic toxicity): 395 mg/kg bw/day Fukushima et al..., 1982 in (SCCS, 2015)/KL4 112-week carcinogenicity 0, 2500, 5000, 10000, 15000 and 20000 ppm At 1500 mg/kg bw/day, transitional cell carcinoma NOAEL (carcinogenicity Niho et al..., 2002 in (SCCS,","page":96,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_077"}
SCCS_vision_codex NOAEL =2000 mg/kg bw/day rat dermal 52-week NOAEL study {"dose":"90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 97 Study type, Species Doses Key findings NOAEL/ LOAEL Reference / KL rating study in male F344 r...","effect":"SCCS/1669/24 Final version Opinion on the safety of Biphenyl-2-ol and Sodium 2-biphenylolate (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 97 Study type, Species Doses Key findings NOAEL/ LOAEL Reference / KL rating study in male F344 rats (50 /group) equivalent to approximately 250, 500, 1000, 1500 and 2000 mg/kg bw/day was observed in rats. At 1500 mg/kg bw/day and above, urinary bladder tumour formation was observed. and systemic toxicity): 1000 mg/kg bw/day 2015{Cal EPA, 2007 #4752)} /KL2 Dermal 52-week, two- stage mouse skin carcinogenesis study in female CD-1 mice Initiation: SOPP in DMSO (10 mg/100 µL) or DMBA ( (10 µg/100 µl) twice weekly for 5 weeks. Promotion: starting 1 week after last","page":97,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_078"}
SCCS_vision_codex NOAEL =224 mg/kg bw/day rat - - carcinogenicity {"dose":"In the first study, the LOAEL for systemic toxicity and carcinogenicity was established at 270 and 224 mg/kg bw/day in males and females, respectively.","effect":"isher Exact test, as calculated by DPR in Cal EPA, 2007: significant at p<0.05, p<0.01, p<0.001, respectively. +,++,+++ Cochran-Armitage trend test, as calculated by DPR in Cal EPA, 2007; significant at p<0.05, p<0.01, and p<0.001, respectively. Conclusion Under the study conditions, SOPP was assessed to be carcinogenic in Fischer 344 rats. In the first study, the LOAEL for systemic toxicity and carcinogenicity was established at 270 and 224 mg/kg bw/day in males and females, respectively. In the second study, the NOAEL for both systemic toxicity and carcinogenicity was established at 95 and 113 mg/kg bw/day in males and females, respectively. Note: The non-neoplastic changes such as interstitial nephritis and pyelonephritis and neoplastic changes such as transitional cell papilloma and carcinoma in the kidneys and carcinomas/papilloma induced in the bladder at 224/270 mg/kg bw/day did not reach statistical significance. However, in their evaluation, Cal EPA (2007) considered the observations to be treatment-related findings beca","page":102,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_081"}
SCCS_vision_codex NOAEL =65 - - - - NOAEL study {"effect":"Unlabeled table on page 65: Study type, | Doses | Key findings | NOAEL or | Reference#/ KL rating","page":65,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_082"}
SCCS_vision_codex NOAEL =66 - - - - NOAEL study {"effect":"Unlabeled table on page 66: Study type, Species | Doses | Key findings | NOAEL or LOAEL | Reference#/ KL rating","page":66,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_089"}
SCCS_vision_codex NOAEL =67 - - - - NOAEL study {"effect":"Unlabeled table on page 67: Study type, Species | Doses | Key findings | NOAEL or LOAEL | Reference#/ KL rating","page":67,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_096"}
SCCS_vision_codex NOAEL =4 % mouse oral 13-week NOAEL study {"dose":"13-week dietary study in B6C3F1 mice | 0, 0.25, 0.5, 1.0, 2.0 and 4.0% (correspond- ding to | At 5375/6349 mg/kg bw/day, ↓ body weight, ↓ mean food | NOAEL:","effect":"Unlabeled table on page 67: 13-week dietary study in B6C3F1 mice | 0, 0.25, 0.5, 1.0, 2.0 and 4.0% (correspond- ding to | At 5375/6349 mg/kg bw/day, ↓ body weight, ↓ mean food | NOAEL: 3529 and 4294 mg/kg bw/day for males | Shibata et al., 1981, 1985 in (SCCS, 2015)/KL2","page":67,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_099"}
SCCS_vision_codex NOAEL =68 - - - - NOAEL study {"effect":"Unlabeled table on page 68: Study type, Species | Doses | Key findings | NOAEL or LOAEL | Reference#/ KL rating","page":68,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_104"}
SCCS_vision_codex NOAEL =69 - - - - NOAEL study {"effect":"Unlabeled table on page 69: Study type, Species | Doses | Key findings | NOAEL or LOAEL","page":69,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_111"}
SCCS_vision_codex NOAEL =240 mg/kg bw/day mouse dermal 4-week NOAEL study {"dose":"4-week dermal toxicity study in Swiss Webster CFW mice (10/sex/group); no guideline | 0, 5.95, 11.4, 20.8, 35.7 and 55.5 mg / 0.1 mL acetone (corresponding to weighted average doses of 0, 383.1, 699.08, 1200 and 1865 mg/kg bw/day for males 0, 460.21, 839.70, 1441.20 and 2240.53 mg/kg bw/day for females respectively) 3 days/week | Ulcerative lesi...","effect":"Unlabeled table on page 69: 4-week dermal toxicity study in Swiss Webster CFW mice (10/sex/group); no guideline | 0, 5.95, 11.4, 20.8, 35.7 and 55.5 mg / 0.1 mL acetone (corresponding to weighted average doses of 0, 383.1, 699.08, 1200 and 1865 mg/kg bw/day for males 0, 460.21, 839.70, 1441.20 and 2240.53 mg/kg bw/day for females respectively) 3 days/week | Ulcerative lesions at the site of application were observed in all mice that received ≤20.8 mg; in 6/10 males and 9/10 females that received 11.4 mg; in 2/10 males and 7/10 females that received 5.95 mg, and in 1/10 male and 1/10 female of control group | LOAEL (dermal toxicity): 5.95 mg (equivalent to 200 / 240 mg/kg bw/day for males and females, respectively) | NTP, 1986 in ECHA RAC, 2022/KL2","page":69,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_113"}
SCCS_vision_codex NOAEL =70 - - - - NOAEL study {"effect":"Unlabeled table on page 70: Study type, Species | Doses | Critical effects | NOAEL or LOAEL | Reference#/ KL rating","page":70,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_115"}
SCCS_vision_codex NOAEL =71 - - - - NOAEL study {"effect":"Unlabeled table on page 71: Study type, Species | Doses | Critical effects | NOAEL or LOAEL | Reference#/ KL rating","page":71,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_118"}
SCCS_vision_codex NOAEL =72 - - - - NOAEL study {"effect":"Unlabeled table on page 72: Study type, Species | Doses | Critical effects | NOAEL or LOAEL | Reference#/ KL rating","page":72,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_121"}
SCCS_vision_codex NOAEL =73 - - - - NOAEL study {"effect":"Unlabeled table on page 73: Study type, Species | Doses | Critical effects | NOAEL or LOAEL | Reference#/ KL rating","page":73,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_123"}
SCCS_vision_codex NOAEL =74 - - - - NOAEL study {"effect":"Unlabeled table on page 74: Study type, Species | Doses | Critical effects | NOAEL or LOAEL | Reference#/ KL rating","page":74,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_126"}
SCCS_vision_codex NOAEL =1200 mg/kg bw/day rat oral Prenatal developmental toxicity {"dose":"Prenatal developmental toxicity via gavage in Wistar rats, (11-20 females/group), similar to OCED TG 414 | 0, 150, 300, 600 and 1200 mg/kg bw/day, GD 6-15 | Maternal toxicity At 1200 mg/kg bw/day, 10/11 dams died after 3-9 days of treatment, clinical signs such as pregnant rats fell into ataxia for several hours.","effect":"Unlabeled table on page 74: Prenatal developmental toxicity via gavage in Wistar rats, (11-20 females/group), similar to OCED TG 414 | 0, 150, 300, 600 and 1200 mg/kg bw/day, GD 6-15 | Maternal toxicity At 1200 mg/kg bw/day, 10/11 dams died after 3-9 days of treatment, clinical signs such as pregnant rats fell into ataxia for several hours. At 600 mg/kg bw/day, ↓ body weight gain, clinical signs such as pregnant rats fell into ataxia for several hours. At 300 mg/kg bw/day, ↓ body weight gain, clinical signs such as pregnant rats fell into ataxia for several hours. Developmental toxicity At 600 mg/kg bw/day, ↑ percentage of foetal death, ↓ mean foetal weight, ↑ foetal incidence of malformations. At 300 mg/kg bw/day, ↑ foetal incidence of malformations | NOAEL (maternal and developmental): 150 mg/kg bw/day Note: SCCS considered the NOAEL for developmental at 600 mg/kg bw/day) | Kaneda et al., 1978 in (ECHA, 2023b; ECHA RAC, 2022; SCCS, 2015)/KL2","page":74,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_127"}
SCCS_vision_codex NOAEL =750 mg/ kg bw/day rabbit oral Prenatal developmental toxicity {"dose":"Range finding Prenatal developmental toxicity via gavage in New Zealand rabbits, (7 females/ group), no guideline | 0, 250, 500 and 750 mg/ kg bw/day GD 7-19 | Maternal toxicity At 750 mg/kg bw/day, mortality: nine rabbits died prior to study termination.","effect":"Unlabeled table on page 74: Range finding Prenatal developmental toxicity via gavage in New Zealand rabbits, (7 females/ group), no guideline | 0, 250, 500 and 750 mg/ kg bw/day GD 7-19 | Maternal toxicity At 750 mg/kg bw/day, mortality: nine rabbits died prior to study termination. Two rabbits (one at 500 and one at 750 mg/kg bw/day) were found withdepositions of the test material in the lungs. The remaining deaths were considered treatment related. ↓ body weight and | LOAEL (maternal toxicity): 250 mg/kg bw/day; Developmental NOAEL cannot be established, since foetuses were not examined for skeletal, visceral, and external anomalies | Zablotny et al., 1991, in (ECHA RAC, 2022; SCCS, 2015) /KL2","page":74,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_128"}
SCCS_vision_codex NOAEL =75 - - - - NOAEL study {"effect":"Unlabeled table on page 75: Study type, Species | Doses | Critical effects | NOAEL or LOAEL | Reference#/ KL rating","page":75,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_131"}
SCCS_vision_codex NOAEL =76 - - - - NOAEL study {"effect":"Unlabeled table on page 76: Study type, Species | Doses | Critical effects | NOAEL or LOAEL | Reference#/ KL rating","page":76,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_134"}
SCCS_vision_codex NOAEL =93 - - - - NOAEL study {"effect":"Unlabeled table on page 93: Study type, Species | Doses | Key findings | NOAEL/ LOAEL | Reference / KL rating","page":93,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_136"}
SCCS_vision_codex NOAEL =10000 ppm rat - 2-year carcinogenicity {"dose":"2-year combined chronic toxicity/ carcinogenicity study in CDF[F344]/BR rats | 0, 800, 4000 and 8000/ 10000 ppm (equivalent to 0, 39/49, 200/248 and 402/647 mg/kg bw/day in | At 402/647 mg/kg bw/day, ↑ incidence of urinary bladder masses, ↑ incidence of pitted zones in kidneys.","effect":"Unlabeled table on page 93: 2-year combined chronic toxicity/ carcinogenicity study in CDF[F344]/BR rats | 0, 800, 4000 and 8000/ 10000 ppm (equivalent to 0, 39/49, 200/248 and 402/647 mg/kg bw/day in | At 402/647 mg/kg bw/day, ↑ incidence of urinary bladder masses, ↑ incidence of pitted zones in kidneys. Neoplastic changes such as ↑ incidence of transitional | NOAEL (carcinogenicity and systemic toxicity): 39 and 49 mg/kg bw/day in males | Wahle et al...,1996 in (ECHA, 2023b; ECHA RAC, 2022;","page":93,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_139"}
SCCS_vision_codex NOAEL =94 - - - - NOAEL study {"effect":"Unlabeled table on page 94: Study type, Species | Doses | Key findings | NOAEL/ LOAEL | Reference / KL rating","page":94,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_143"}
SCCS_vision_codex NOAEL =2 % rat - 2-year carcinogenicity {"dose":"Similar to OECD TG 453 | 0, 0.02, 0.2 and 2% equivalent to 0, 10, 100 and 1000 mg/kg bw/day | At 1000 mg/kg bw/day, ↓ body weight, ↑weight of testes and histopathological changes such as extensive renal damage, characterised by tubular dilation with varying degrees of acute and chronic inflammation was observed. | NOAEL:","effect":"Unlabeled table on page 94: 2-year combined chronic toxicity/ carcinogenicity study in weanling Rochester rats (25/sex/group); Similar to OECD TG 453 | 0, 0.02, 0.2 and 2% equivalent to 0, 10, 100 and 1000 mg/kg bw/day | At 1000 mg/kg bw/day, ↓ body weight, ↑weight of testes and histopathological changes such as extensive renal damage, characterised by tubular dilation with varying degrees of acute and chronic inflammation was observed. | NOAEL: 100 mg/kg bw/day | Hodge HC., et al... 1952 in (EC, 2023)/KL2","page":94,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_144"}
SCCS_vision_codex NOAEL =95 - - - - NOAEL study {"effect":"Unlabeled table on page 95: Study type, Species | Doses | Key findings | NOAEL/ LOAEL | Reference / KL rating","page":95,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_148"}
SCCS_vision_codex NOAEL =20000 ppm - oral 2-year carcinogenicity {"dose":"0, 7000 and 20000 ppm, | At 466/770 mg/kg bw/day, ↑ focal atrophy of the | LOAEL (carcinogenicity | Hiraga et al..., 1983 in (SCCS,","effect":"Unlabeled table on page 95: 2-year dietary carcinogenicity | 1st study: Males: 0, 7000 and 20000 ppm, | At 466/770 mg/kg bw/day, ↑ focal atrophy of the | LOAEL (carcinogenicity | Hiraga et al..., 1983 in (SCCS,","page":95,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_152"}
SCCS_vision_codex NOAEL =96 - - - - NOAEL study {"effect":"Unlabeled table on page 96: Study type, Species | Doses | Key findings | NOAEL/ LOAEL | Reference / KL rating","page":96,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_153"}
SCCS_vision_codex NOAEL =97 - - - - NOAEL study {"effect":"Unlabeled table on page 97: Study type, Species | Doses | Key findings | NOAEL/ LOAEL | Reference / KL rating","page":97,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_160"}
SCCS_vision_codex NOAEL >98 % rat oral 24 months NOAEL study {"citation":"Ref.: 106 SCCS comment Due to poor reporting the study cannot be used to derive a NOAEL","dose":"Decreased (p<0.01) body weights occurred in males (10 %) and females (6 %) at 20000 ppm.","effect":"SCCS-rejected applicant NOAEL: rol groups, only 22-32 % of the animals were alive at the end of 24 months. Decreased (p<0.01) body weights occurred in males (10 %) and females (6 %) at 20000 ppm. Another effect observed at the highest dose level was increased relative testis weight (46 %). Extensive renal damage characterised by marked tubular dilation with varying degrees of acute and chronic inflammation was found in male and female animals at the highest dose. Ref.: 106 SCCS comment Due to poor reporting the study cannot be used to derive a NOAEL. In a study from the open literature, Dowicide 1 (Lot MM01040, purity > 98 %) was administered for 91 weeks to male F344/DuCrj rats at dietary concentrations of 0, 0.625, 1.25 and 2.5 % corresponding to 0, 269, 531 and 1140 mg/kg bw/d. Survival was 100 %, 71 % (p < 0.05) and 65 % (p < 0.05) at 269, 531 and 1140 mg/kg bw/d, respectively. The following findings were observed in treated animals: increased (20 %) white blood cell count at the highest dose, hematuria at 531 and 1140 mg/kg bw/d, increased water intake","page":24,"pdf":"sccs_o_177.pdf","row_type":"noael_study","study_id":"sccs_o_177_noael_001"}
SCCS_vision_codex NOAEL =92 mg/kg/day mouse - - NOAEL study {"citation":"Ref.: 165, 166 SCCS conclusion Apparently the study was not performed according to an accepted guideline","dose":"ion to the increased incidence, the lesion severity (e.g., tubular epithelium degeneration) also appeared to increase with dose.","effect":"ion to the increased incidence, the lesion severity (e.g., tubular epithelium degeneration) also appeared to increase with dose. Reduced (p<0.05) absolute kidney weights occurred in each of the OPP-treated groups (7-24 %), but the dose-response seemed consistent with the general body weight reductions noted in these groups (12-43 %). Based on the induction of renal tubular epithelium degeneration, spleen atrophy, increased water intake, and increased relative liver weight, occurring at each concentration tested, a NOAEL cannot be derived. 92 mg/kg/day can be considered as LOAEL. Ref.: 165, 166 SCCS conclusion Apparently the study was not performed according to an accepted guideline. Only male animals were used in the study. The study can be used as supporting information about OPP target tissues in mice. Tumour incidences in the liver did not represent a dose response. Types of liver cancers were not reported. Guideline: OECD TG 453 Species/strain: mouse, B6C3F1 Group size: 50/sex/dose (main group) 10/sex/dose (satellite grou","page":25,"pdf":"sccs_o_177.pdf","row_type":"noael_study","study_id":"sccs_o_177_noael_002"}
SCCS_vision_codex NOAEL =250 mg/kg bw/d mouse oral 5d NOAEL study {"citation":"Ref.: 220, 221 In a GLP-compliant study four groups of beagle dogs (4 animals/sex/dose) received OPP (purity 99","dose":"ignificantly increased in livers of male mice, however, a statistically significant increase in hepatocellular adenoma was observed at the two highest doses (27/50 in controls, 33/50 at 250 mg/kg, 40/50 at 500 mg/kg, and 41/50 at 1000 mg/kg).","effect":"ignificantly increased in livers of male mice, however, a statistically significant increase in hepatocellular adenoma was observed at the two highest doses (27/50 in controls, 33/50 at 250 mg/kg, 40/50 at 500 mg/kg, and 41/50 at 1000 mg/kg). In female mice, also microscopic changes in livers were seen, however, no female mouse had a hepatoblastoma and there were no statistically significant increases in liver or other tumours in the female animals. As treatment-related effects were observed in all dose groups, no NOAEL can be derived from this study. The LOAEL is considered to be 250 mg/kg bw/d. SCCS comment In this study in mice, the heart was not identified as a target organ. CalEpa considered the incidence of hepatoblastoma at the mid dose as treatment-related due to its rare spontaneous occurrence in this strain. Ref.: 220, 221 In a GLP-compliant study four groups of beagle dogs (4 animals/sex/dose) received OPP (purity 99.77 %, identification #8800005-24) at gavage doses of 0, 30, 100, or 300 mg/kg bw/d, 5d / week, for","page":26,"pdf":"sccs_o_177.pdf","row_type":"noael_study","study_id":"sccs_o_177_noael_003"}
SCCS_vision_codex NOAEL >300 mg/kg/day mouse oral 5d NOAEL study {"citation":"Ref.: 220, 221 In a GLP-compliant study four groups of beagle dogs (4 animals/sex/dose) received OPP (purity 99","dose":"incidence of hepatoblastoma at the mid dose as treatment-related due to its rare spontaneous occurrence in this strain.","effect":"incidence of hepatoblastoma at the mid dose as treatment-related due to its rare spontaneous occurrence in this strain. Ref.: 220, 221 In a GLP-compliant study four groups of beagle dogs (4 animals/sex/dose) received OPP (purity 99.77 %, identification #8800005-24) at gavage doses of 0, 30, 100, or 300 mg/kg bw/d, 5d / week, for one year. There were no effects on body weight, feed consumption, ophthalmology, haematology, urinalysis, and pathology. The only clinical sign was vomiting (dose-dependent increase). A NOAEL > 300 mg/kg/day can be derived from this study. Ref.: 32 Dermal mouse Swiss CD-1 mice (50/sex) received repeated dermal applications of 55 mg OPP (99 % purity, lot MM09157), dissolved in 0.1 ml acetone solution for 102 weeks. Treatment did not affect survival and body weight. No skin neoplasms occurred in mice dosed with OPP, however non-neoplastic lesions (ulcer, active chronic inflammation, hyperkeratosis and acanthosis) were observed at the application site. Systemically, slightly increased incidences of di","page":26,"pdf":"sccs_o_177.pdf","row_type":"noael_study","study_id":"sccs_o_177_noael_004"}
SCCS_vision_codex NOAEL =39 mg/kg bw/d rat oral 2-year reproductive toxicity {"citation":"(Ref. 303)","dose":"303), a NOAEL of 39 mg/kg bw/d was obtained based on urinary bladder hyperplasia and urinary bladder transitional cell carcinoma.","effect":"OPP) • Species- and strain-specific differences (OPP-induced bladder tumours were not observed in female rats, mice, dogs) • dermal application to mice does not affect tumour incidence in skin • no skin tumour development induced by OPP metabolites • tumours occur at high doses when sulfate and glucuronide conjugation pathways are saturated The threshold for OPP-induced bladder tumours can be approached from different studies all yielding a quite consistent picture: In a 2-year bioassay in F344 rats (Ref. 303), a NOAEL of 39 mg/kg bw/d was obtained based on urinary bladder hyperplasia and urinary bladder transitional cell carcinoma. In a study investigating cytotoxicity and regenerative hyperplasia in male F344 rats fed different levels of OPP (Ref. 263), no effects were observed at a dose level of 0.08 % OPP in diet (corresponding to approximately 40 mg/kg bw/d). In a 2-generation reproductive toxicity study (see section 3.3.8.1) performed in Sprague-Dawley rats, a NOAEL of 35 mg/kg bw/d was identified based on morphological ch","page":32,"pdf":"sccs_o_177.pdf","row_type":"noael_study","study_id":"sccs_o_177_noael_005"}
SCCS_vision_codex NOAEL =35 mg/kg bw/d rat oral 2-year reproductive toxicity {"citation":"(Ref. 303)","dose":"303), a NOAEL of 39 mg/kg bw/d was obtained based on urinary bladder hyperplasia and urinary bladder transitional cell carcinoma.","effect":"picture: In a 2-year bioassay in F344 rats (Ref. 303), a NOAEL of 39 mg/kg bw/d was obtained based on urinary bladder hyperplasia and urinary bladder transitional cell carcinoma. In a study investigating cytotoxicity and regenerative hyperplasia in male F344 rats fed different levels of OPP (Ref. 263), no effects were observed at a dose level of 0.08 % OPP in diet (corresponding to approximately 40 mg/kg bw/d). In a 2-generation reproductive toxicity study (see section 3.3.8.1) performed in Sprague-Dawley rats, a NOAEL of 35 mg/kg bw/d was identified based on morphological changes in the urinary bladder (Ref. 36). SCCS conclusions on chronic toxicity and carcinogenicity The urinary bladder and kidneys of rats are the main target tissues after chronic administration of OPP and SOPP. OPP and SOPP resulted in urinary bladder tumours (papilloma and carcinoma, mainly transitional cell papilloma and carcinoma) in male F344 rats. At higher doses, also the renal pelvis and the renal papilla are target tissues for OPP- and SOPP toxicity","page":32,"pdf":"sccs_o_177.pdf","row_type":"noael_study","study_id":"sccs_o_177_noael_006"}
SCCS_vision_codex NOAEL =457 mg/kg rat - - reproductive toxicity {"citation":"Ref.: 36 SCCS comment SCCS notes that based on deviations from the Guideline protocol, Kwock and Silva (2013) stated that assessments on fertility in that study were inconclusive","dose":"The incidence of calculi in the kidney and/or urinary bladder was increased in male P and F1 rats at 125 and 457 mg/kg.","effect":"and F1 adults. The incidence of calculi in the kidney and/or urinary bladder was increased in male P and F1 rats at 125 and 457 mg/kg. Transitional cell hyperplasia/papillomatosis in the urinary bladder was diagnosed in 457 mg/kg P males and females and in 457 mg/kg F1 males. Morphometry measurements confirmed the microscopic findings at 457 mg/kg and indicated a compound-related effect also in 125 mg/kg P males and females. No embryotoxic or teratogenic effects were observed at doses up to 457 mg/kg. The overall NOAEL for the adults, based on morphological changes, was considered as 35 mg/kg. Ref.: 36 SCCS comment SCCS notes that based on deviations from the Guideline protocol, Kwock and Silva (2013) stated that assessments on fertility in that study were inconclusive. Guideline: OECD TG 416 Species/strain: rat, CD Sprague-Dawley Group size: 30/sex/dose Test substance: OPP, technical grade Batch: S-01-93 (mixture of OPP from Dow and Bayer) Purity: 99.5 – 100 % Vehicle: / Dose levels: 0, 20, 100, 500 mg/kg bw/d Dose volume: /","page":33,"pdf":"sccs_o_177.pdf","row_type":"noael_study","study_id":"sccs_o_177_noael_007"}
SCCS_vision_codex NOAEL =500 mg/kg bw/d - - chronic reproductive toxicity {"citation":"Ref.:37, 38 SCCS comment Some important reprotoxic parameters (e","dose":", and an increased severity of background lesions in the kidneys, transitional cell hyperplasia (simple and/or nodular/papillary), calculi, and chronic inflammation in the urinary bladder as well as dilatation and hyperplasia of the ureter in P and F1 males at 500 mg/kg.","effect":", and an increased severity of background lesions in the kidneys, transitional cell hyperplasia (simple and/or nodular/papillary), calculi, and chronic inflammation in the urinary bladder as well as dilatation and hyperplasia of the ureter in P and F1 males at 500 mg/kg. There were no effects on adult reproductive parameters. Pup weights were lower at 500 mg/kg bw/d. No effects were seen on litter size, gender distribution, number of stillborn, viability, clinical signs or gross pathology of pups. The reproductive NOAEL in this study was considered to be 500 mg/kg bw/d. The parental and neonatal NOAEL was considered to be 100 mg/kg based on decreased body weights, decreased pup weights and morphologic lesions in kidneys, urinary bladder and urether at 500 mg/kg bw/d. Ref.:37, 38 SCCS comment Some important reprotoxic parameters (e.g. sperm parameters, yellow bodies, weight of some reproductive organs) were not assessed in this study. 3.3.8.2 Other data on fertility and reproduction toxicity / 3.3.8.3 Developmental Toxicity R","page":34,"pdf":"sccs_o_177.pdf","row_type":"noael_study","study_id":"sccs_o_177_noael_008"}
SCCS_vision_codex NOAEL =100 mg/kg rabbit - chronic reproductive toxicity {"citation":"Ref.:37, 38 SCCS comment Some important reprotoxic parameters (e","dose":"hyperplasia (simple and/or nodular/papillary), calculi, and chronic inflammation in the urinary bladder as well as dilatation and hyperplasia of the ureter in P and F1 males at 500 mg/kg.","effect":"hyperplasia (simple and/or nodular/papillary), calculi, and chronic inflammation in the urinary bladder as well as dilatation and hyperplasia of the ureter in P and F1 males at 500 mg/kg. There were no effects on adult reproductive parameters. Pup weights were lower at 500 mg/kg bw/d. No effects were seen on litter size, gender distribution, number of stillborn, viability, clinical signs or gross pathology of pups. The reproductive NOAEL in this study was considered to be 500 mg/kg bw/d. The parental and neonatal NOAEL was considered to be 100 mg/kg based on decreased body weights, decreased pup weights and morphologic lesions in kidneys, urinary bladder and urether at 500 mg/kg bw/d. Ref.:37, 38 SCCS comment Some important reprotoxic parameters (e.g. sperm parameters, yellow bodies, weight of some reproductive organs) were not assessed in this study. 3.3.8.2 Other data on fertility and reproduction toxicity / 3.3.8.3 Developmental Toxicity Rabbits Guideline: OECD TG 414 Species/strain: Female rabbit, White New Zealand Gro","page":34,"pdf":"sccs_o_177.pdf","row_type":"noael_study","study_id":"sccs_o_177_noael_009"}
SCCS_vision_codex NOAEL =100 mg/kg/d rat - developmental developmental toxicity {"citation":"Ref.: 319","dose":"11.1 – 66.7 %) were observed at 100 (77 %) and 250 (72 %) mg/kg/d.","effect":"nomalies or malformations (data not shown). The only developmental effect of OPP in rabbits was increased incidence of litters with resorptions. Kwock and Silva (2013) carefully re-examined all available data considering probable statistical pitfalls. They came to the conclusion that statistically significant increases in resorptions clearly exceeding the actual control group (33.3 %) and the mean of historical controls (36.2 %, range: 11.1 – 66.7 %) were observed at 100 (77 %) and 250 (72 %) mg/kg/d. The maternal NOAEL was set at 100 mg/kg/d and the developmental NOAEL was set at 25 mg/kg/d. A NOAEL of 25 mg/kg bw/d will be taken for MOS calculation. Ref.: 319; Kwock and Silva (2013) Rats In a study from the open literature, OPP (commercial grade biocide, 99.69 % purity) at dose levels of 0, 100, 300 and 700 mg/kg bw/d was investigated in pregnant Sprague- Dawley rats (24 – 26 dams/dose; 36 control animals) for embryotoxic and teratogenic effects. Dose levels were based on the results of a range-finding study. One dam died at","page":35,"pdf":"sccs_o_177.pdf","row_type":"noael_study","study_id":"sccs_o_177_noael_010"}
SCCS_vision_codex NOAEL =25 mg/kg/d rat - developmental developmental toxicity {"citation":"Ref.: 319","dose":"11.1 – 66.7 %) were observed at 100 (77 %) and 250 (72 %) mg/kg/d.","effect":"y developmental effect of OPP in rabbits was increased incidence of litters with resorptions. Kwock and Silva (2013) carefully re-examined all available data considering probable statistical pitfalls. They came to the conclusion that statistically significant increases in resorptions clearly exceeding the actual control group (33.3 %) and the mean of historical controls (36.2 %, range: 11.1 – 66.7 %) were observed at 100 (77 %) and 250 (72 %) mg/kg/d. The maternal NOAEL was set at 100 mg/kg/d and the developmental NOAEL was set at 25 mg/kg/d. A NOAEL of 25 mg/kg bw/d will be taken for MOS calculation. Ref.: 319; Kwock and Silva (2013) Rats In a study from the open literature, OPP (commercial grade biocide, 99.69 % purity) at dose levels of 0, 100, 300 and 700 mg/kg bw/d was investigated in pregnant Sprague- Dawley rats (24 – 26 dams/dose; 36 control animals) for embryotoxic and teratogenic effects. Dose levels were based on the results of a range-finding study. One dam died at 700 mg/kg bw/day due to dosing error but there were","page":35,"pdf":"sccs_o_177.pdf","row_type":"noael_study","study_id":"sccs_o_177_noael_011"}
SCCS_vision_codex NOAEL =100 mg/kg bw/d rat oral - NOAEL study {"citation":"Ref.: 129","dose":"hree skeletal anomalies were statistically significantly increased (~13-15 %) at 700 mg/kg/d (delayed ossification of sternebrae, pinpoint holes in the occipital or interparietal plates in the skull, and skull bone island).","effect":"hree skeletal anomalies were statistically significantly increased (~13-15 %) at 700 mg/kg/d (delayed ossification of sternebrae, pinpoint holes in the occipital or interparietal plates in the skull, and skull bone island). Kwock and Silva (2013) discuss, that pre-implantation losses, which were observed at the highest dose tested, might be instances of early resorptions due to the methodologies applied for evaluation of this effect. Based on the results of this study, 100 mg/kg bw/d should be regarded as maternal NOAEL (due to decreased body weight and food consumption at 300 mg/kg bw/d) and 300 mg/kg bw/d should be regarded as the foetal NOAEL. Ref.: 129; Kwock and Silva (2013) In a further study from the open literature (no information on guideline adherence or GLP), pregnant Wistar rats (18-20 dams/dose; 11 dams at the highest dose tested) were treated with OPP (99.7 % purity) by gavage at 0 (aqueous gum arabic), 150, 300, 600, or 1200 mg/kg bw/d on gestation days (GD) 6 through 15. The animals were sacrificed on GD 20. At","page":36,"pdf":"sccs_o_177.pdf","row_type":"noael_study","study_id":"sccs_o_177_noael_013"}
SCCS_vision_codex NOAEL =300 mg/kg bw/d rat oral 9 days NOAEL study {"citation":"Ref.: 129","dose":"Kwock and Silva (2013) discuss, that pre-implantation losses, which were observed at the highest dose tested, might be instances of early resorptions due to the methodologies applied for evaluation of this effect.","effect":", pinpoint holes in the occipital or interparietal plates in the skull, and skull bone island). Kwock and Silva (2013) discuss, that pre-implantation losses, which were observed at the highest dose tested, might be instances of early resorptions due to the methodologies applied for evaluation of this effect. Based on the results of this study, 100 mg/kg bw/d should be regarded as maternal NOAEL (due to decreased body weight and food consumption at 300 mg/kg bw/d) and 300 mg/kg bw/d should be regarded as the foetal NOAEL. Ref.: 129; Kwock and Silva (2013) In a further study from the open literature (no information on guideline adherence or GLP), pregnant Wistar rats (18-20 dams/dose; 11 dams at the highest dose tested) were treated with OPP (99.7 % purity) by gavage at 0 (aqueous gum arabic), 150, 300, 600, or 1200 mg/kg bw/d on gestation days (GD) 6 through 15. The animals were sacrificed on GD 20. At the highest dose tested, 10/11 dams died after 3-9 days of treatment. At 600 mg/kg bw/d, 2 of the 20 dams died. At ≥ 300 mg/kg b","page":36,"pdf":"sccs_o_177.pdf","row_type":"noael_study","study_id":"sccs_o_177_noael_014"}
SCCS_vision_codex NOAEL =150 mg/kg mouse - developmental developmental toxicity {"citation":"Ref.:133","dose":"At ≥ 300 mg/kg bw/d, pregnant animals fell into ataxia for several hours and there was a dose-related increase.","effect":"g/kg bw/d, 2 of the 20 dams died. At ≥ 300 mg/kg bw/d, pregnant animals fell into ataxia for several hours and there was a dose-related increase. At doses ≥ 300 mg/kg bw/d, dams had decreased body weight gains from GD 9. Effects to foetuses from OPP exposure in utero at the 600 mg/kg bw/d group appeared as an increased (p<0.01) incidence of resorptions and reduced foetal body weights (both sexes). From the results of the study it can be concluded that foetal effects occurred at maternally toxic doses. The maternal NOAEL can be set at 150 mg/kg be/d based on decreased body weight gain and occurrence of ataxia from 300 mg/kg bw/d. The foetal (developmental) NOAEL can be set at 600 mg/kg bw/d based on reduced foetal body weight and an increased incidence of resorptions. Ref.:133; Kwock and Silva (2013) Mice The developmental toxicity of OPP (from Tokyo Kasei Ltd., Lot FB 103) and SOPP (from Dow, Lot MM0144) has been investigated in mice. No information on guideline adherence or GLP is available. In the study with OPP, four groups","page":36,"pdf":"sccs_o_177.pdf","row_type":"noael_study","study_id":"sccs_o_177_noael_015"}
SCCS_vision_codex NOAEL =600 mg/kg bw/d mouse oral developmental developmental toxicity {"citation":"Ref.:133","dose":"At doses ≥ 300 mg/kg bw/d, dams had decreased body weight gains from GD 9.","effect":". At doses ≥ 300 mg/kg bw/d, dams had decreased body weight gains from GD 9. Effects to foetuses from OPP exposure in utero at the 600 mg/kg bw/d group appeared as an increased (p<0.01) incidence of resorptions and reduced foetal body weights (both sexes). From the results of the study it can be concluded that foetal effects occurred at maternally toxic doses. The maternal NOAEL can be set at 150 mg/kg be/d based on decreased body weight gain and occurrence of ataxia from 300 mg/kg bw/d. The foetal (developmental) NOAEL can be set at 600 mg/kg bw/d based on reduced foetal body weight and an increased incidence of resorptions. Ref.:133; Kwock and Silva (2013) Mice The developmental toxicity of OPP (from Tokyo Kasei Ltd., Lot FB 103) and SOPP (from Dow, Lot MM0144) has been investigated in mice. No information on guideline adherence or GLP is available. In the study with OPP, four groups of Jcl:ICR mice considered pregnant (21 animals/dose) received gavage dosages of 0, 1450, 1740, and 2100 mg/kg bw/d OPP in olive oil from GD 7 t","page":36,"pdf":"sccs_o_177.pdf","row_type":"noael_study","study_id":"sccs_o_177_noael_016"}
SCCS_vision_codex NOAEL =100 mg/kg bw rat - developmental reproductive toxicity {"dose":"No adverse effects of OPP on foetuses of rabbits were observed, however, there were increased incidences of resorptions independent from maternal toxicity, leading to a developmental NOAEL of 25 mg/kg bw/d.","effect":"n investigated in rabbits, rats and mice and there is a report on developmental toxicity of SOPP in mice. No adverse effects of OPP on foetuses of rabbits were observed, however, there were increased incidences of resorptions independent from maternal toxicity, leading to a developmental NOAEL of 25 mg/kg bw/d. An increased incidence of resorption was also reported from developmental toxicity studies performed with OPP in rats. The lowest maternal NOAEL of OPP identified in rats was 100 mg/kg bw whereas the lowest NOAEL for development identified in rats was 300 mg/kg bw/d. In mice treated with comparably high doses of OPP, maternal and developmental effects were observed at all concentrations tested and an LOAEL of 1450 mg/kg bw/d was identified. In mice treated with SOPP, developmental effects (reduced foetal weight and increased incidence of cleft palate) could be observed at the lowest dose tested (100 mg/kg bw/d). As a summary, whereas OPP does not adversely affect fertility or reproductive","page":37,"pdf":"sccs_o_177.pdf","row_type":"noael_study","study_id":"sccs_o_177_noael_019"}
SCCS_vision_codex NOAEL =25 mg/kg bw/d - - developmental developmental toxicity {"citation":"(ref. California Environmental Protection Agency, April 2007. Ortho-Phenylphenol (OPP)","dose":"The lowest developmental NOAEL identified was 25 mg/kg bw/d, which will be taken for MOS calculation.","effect":"SCCS/1555/15 Revision of the Opinion on o-Phenylphenol, Sodium o-phenylphenate and Potassium o-phenylphenate ____________________________________________________________________________________________________________________ 38 organs, increased incidence of resorptions can be considered as a developmental effect of OPP and SOPP. The lowest developmental NOAEL identified was 25 mg/kg bw/d, which will be taken for MOS calculation. 3.3.9 Toxicokinetics 3.3.9.1 Toxicokinetics in laboratory animals The toxicokinetics of OPP has been investigated in vitro and in vivo in different species. The principal metabolic pathways are given in figure 1. Figure 1: Overview on the metabolic pathways of OPP in different mammalian species (ref. California Environmental Protection Agency, April 2007. Ortho-Phenylphenol (OPP) and Sodium Ortho-Phenylphenate (SOPP), Risk Characteriza","page":38,"pdf":"sccs_o_177.pdf","row_type":"noael_study","study_id":"sccs_o_177_noael_020"}
SCCS_vision_codex NOAEL =100 % rabbit oral developmental developmental toxicity {"dose":"Absorption through the skin DAp (%) = 45 % Amount of cosmetic product applied daily A (g/d) = 17.4 g/d Concentration of ingredient in finished product C (%) = 0.2 % Typical body weight of human = 60 kg Systemic exposure dose (SED) = A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60 = 0.261 mg/kg bw/d No adverse observed effect level NOAEL = 25 m...","effect":"MoS calculation according to the SCCS's Notes of Guidance 8th revision. Absorption through the skin DAp (%) = 45 % Amount of cosmetic product applied daily A (g/d) = 17.4 g/d Concentration of ingredient in finished product C (%) = 0.2 % Typical body weight of human = 60 kg Systemic exposure dose (SED) = A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60 = 0.261 mg/kg bw/d No adverse observed effect level NOAEL = 25 mg/kg bw/d (oral developmental toxicity study, rabbit) No adjustment, 100 % oral absorption MOS NOAEL/SED = 96 2. Rinse-off products An aggregate value of 0.54 g/d (8.3 mg/kg bw/d) for the amount of cosmetics applied daily is taken for MoS calculation, according to the SCCS's Notes of Guidance 8th revision. Absorption through the skin DAp (%) = 45 % Amount of cosmetic product applied daily A (g/d) = 0.54 g/d Concentration of ingredient in finished product C (%) = 0.2 % Typical body weight of human = 60 kg Systemic exposure dose (SED) = A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60 = 0.0081 mg/kg bw/d No","page":47,"pdf":"sccs_o_177.pdf","row_type":"noael_study","study_id":"sccs_o_177_noael_025"}
SCCS_vision_codex NOAEL =4 % rat oral - NOAEL study {"dose":"352, 694, 1338, and 2431 mg/kg bw/day for females papillomas plus 5 transitional cell carcinomas at 2% and 1 transitional cell carcinoma at 4%, as opposed to only 2 papillomas at 4% in females.","effect":"352, 694, 1338, and 2431 mg/kg bw/day for females papillomas plus 5 transitional cell carcinomas at 2% and 1 transitional cell carcinoma at 4%, as opposed to only 2 papillomas at 4% in females. No bladder calculi were observed. Moderate pyelonephritis was recorded in 6/10 males and slight in 1/10 females at 4%. No tumours at sites other than the urinary system were found. Liver: increases in liver weight; changes in liver enzymes. Kidneys: pyelonephritis in high dose males and females; increase in kidney weights. NOAEL. In 4 % males: pyelonephritis as predominating effect (60%; p≤0.01); in 2% males: neoplastic lesions in bladder as predominating effect (transitional cell papilloma, 44% (p≤0.05); transitional cell carcinoma 56% (p≤0.01). Purity SOPP > 95% Unclear (Text body in Japanese) male F344 rats (n=20/group) Dietary administration of 0, 0.625, 1.25, or 2.5% Body weight gain dose-dependently decreased at 1.25 and 2.5%. No changes were noted in biochemical investigations of plasma samples. Red blood cell count and the amoun","page":80,"pdf":"sccs_o_177.pdf","row_type":"noael_study","study_id":"sccs_o_177_noael_032"}
SCCS_vision_codex NOAEL =2.5 % rat oral - NOAEL study {"dose":"Unclear (Text body in Japanese) | male F344 rats (n=20/group) Dietary administration of 0, 0.625, 1.25, or 2.5% | Body weight gain dose-dependently decreased at 1.25 and 2.5%.","effect":"Unlabeled table on page 80: Unclear (Text body in Japanese) | male F344 rats (n=20/group) Dietary administration of 0, 0.625, 1.25, or 2.5% | Body weight gain dose-dependently decreased at 1.25 and 2.5%. No changes were noted in biochemical investigations of plasma samples. Red blood cell count and the amount of haemoglobin were decreased at 2.5%. The relative weight of the urinary bladder was dose-dependently increased (nearly by about 50% at the highest concentration). The | Decrease of urinary pH observed; acidification could be due to nephritis; supporting study. Publication in Japanese, only tables and numbers | 190","page":80,"pdf":"sccs_o_177.pdf","row_type":"noael_study","study_id":"sccs_o_177_noael_034"}
SCCS_vision_codex NOAEL =25 mg/kg bw/day rat - developmental developmental toxicity {"dose":"As a result, the LOAEL was established at 1450 mg/kg bw/day.","effect":"l effects were observed at all tested doses. As a result, the LOAEL was established at 1450 mg/kg bw/day. Similarly, an increased incidence of resorptions was reported in rat developmental toxicity studies with OPP. The lowest NOAELs identified for maternal and developmental effects were 100 and 300 mg/kg bw/day, respectively. In rabbits, no adverse effects on foetuses were observed. However, increased incidences of resorptions were noted, and these appeared to be independent of maternal toxicity. As a result, the NOAEL for developmental toxicity was established at 25 mg/kg bw/day. In the mouse study with SOPP, developmental effects, such as reduced foetal weight and an increased incidence of cleft palate, were observed even at the lowest dose tested (100 mg/kg bw/day). The only developmental toxicity study with SOPP, is not considered to be useful in safety assessment due to design and reporting limitations. However, it did suggest SOPP's potential interference with rodent development. In summary, while OPP did not adversely aff","page":31,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_001"}
SCCS_vision_codex NOAEL =25 mg/kg/d rabbit oral developmental reproductive toxicity {"dose":"In summary, while OPP did not adversely affect fertility or reproductive organs, the increased incidence of resorptions can be considered a developmental effect of both OPP and SOPP with a critical NOAEL of 25 mg/kg bw/day.","effect":"potential interference with rodent development. In summary, while OPP did not adversely affect fertility or reproductive organs, the increased incidence of resorptions can be considered a developmental effect of both OPP and SOPP with a critical NOAEL of 25 mg/kg bw/day. SCCS comment on developmental toxicity In SCCS/1555/15, the SCCS derived a NOAEL of 25 mg/kg/d based on a re-analysis by Kwock and Silva (2013) of data from a teratology study performed in New Zealand White Rabbits (Zablotny et al., 1991b). This NOAEL is lower than other PoDs obtained from other repeat- dose/long-term toxicity studies performed with OPP and SOPP. Therefore, this conservative value of 25 mg/kg bw/d is taken for MoS calculation for both, OPP and SOPP. 3.4.6 Mutagenicity / genotoxicity According to the Applicant In in vitro assays with OPP and SOPP, minimal evidence of mutagenicity was observed, while clastogenicity occurred primarily in the presence of overt cytotoxicity. In vivo, micronucleus formation and/or DNA damage after oral or dermal ex","page":31,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_004"}
SCCS_vision_codex NOAEL =250 mg/kg bw/day rat oral chronic carcinogenicity {"dose":"The NOAEL was established at 250 mg/kg bw/day.","effect":"nicity studies conducted with OPP and SOPP via the oral route identified the urinary bladder and kidneys as the main target tissues in mice and rats. A combined chronic toxicity/carcinogenicity study in B6C3F1 mice revealed that OPP induced tumours in liver and changes in kidney tubule morphology. The liver tumours observed in male mice were attributed to the high spontaneous occurrence of liver tumours in this specific mouse strain. The kidney changes included hypertrophy and increased relative kidney weight. The NOAEL was established at 250 mg/kg bw/day. In chronic toxicity/carcinogenicity in rats, kidney effects such as hyperplasia, cysts, infarct, acute inflammation, and papilla mineralisation of the kidney were observed. Further, neoplastic changes related to urinary bladder such as increased incidences of transitional cell carcinomas, papilloma, and increased incidence of calculi, congestion, haemorrhage mineralization and necrosis in the urinary bladder were observed. Based on the above effects, the NOAEL of 39 mg/kg bw/da","page":35,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_005"}
SCCS_vision_codex NOAEL =39 mg/kg bw/day rat - chronic carcinogenicity {"dose":"The NOAEL was established at 250 mg/kg bw/day.","effect":"idney weight. The NOAEL was established at 250 mg/kg bw/day. In chronic toxicity/carcinogenicity in rats, kidney effects such as hyperplasia, cysts, infarct, acute inflammation, and papilla mineralisation of the kidney were observed. Further, neoplastic changes related to urinary bladder such as increased incidences of transitional cell carcinomas, papilloma, and increased incidence of calculi, congestion, haemorrhage mineralization and necrosis in the urinary bladder were observed. Based on the above effects, the NOAEL of 39 mg/kg bw/day was established. In another combined chronic and carcinogenicity study, rats exhibited an increased incidence of hepatocellular adenoma with extensive renal damage characterised by tubular dilation and varying degrees of acute and chronic inflammation at 1000 mg/kg bw/day. Furthermore, a 91-week study in male F344 rats associated OPP treatment with the development of urinary bladder tumours, such as papilloma and carcinoma, primarily transitional cell papilloma and carcinoma at and above 531 mg/","page":35,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_006"}
SCCS_vision_codex NOAEL =95 mg/kg bw/day rat dermal 2- year carcinogenicity {"dose":"The LOAEL for the first study was established at 224 mg/kg bw/day based on the increased incidence of focal atrophy of pancreas in females and the NOAEL was established at 95 mg/kg bw/day.","effect":"a 2- year carcinogenicity study (conducted in 2 parts) in F344 rats, SOPP induced kidney tumours and increased incidences of interstitial nephritis of the kidney and increased incidences of focal atrophy of pancreatic acinar cells in females. Additionally, there was an increased incidence of urinary bladder tumours, including transitional cell papillomas and carcinomas. The LOAEL for the first study was established at 224 mg/kg bw/day based on the increased incidence of focal atrophy of pancreas in females and the NOAEL was established at 95 mg/kg bw/day. In a 112-week study in F344 male rats, transitional cell carcinoma was observed in rats at and above 1500 mg/kg bw/day. In a 102-week dermal carcinogenicity study in Swiss CD-1 mice, OPP did not induce skin neoplasms. In a 52-week, two-stage mouse skin carcinogenesis study in female CD-1 mice, SOPP induced epidermal proliferation and can act as a promoter but not as an initiator or a complete carcinogen. Overall, OPP and SOPP did not induce tumours when applied dermally. However","page":35,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_008"}
SCCS_vision_codex NOAEL =49 mg/kg bw/day rat oral 13 weeks carcinogenicity {"dose":"ssation of 13 weeks of exposure to OPP) • Sex and species- and strain-specific differences (OPP-induced bladder tumours were not observed in female rats, mice, dogs) • dermal application to mice does not affect tumour incidence in skin • no skin tumour development induced by OPP metabolites • tumours occur at high doses when sulfate and glucuron...","effect":"ssation of 13 weeks of exposure to OPP) • Sex and species- and strain-specific differences (OPP-induced bladder tumours were not observed in female rats, mice, dogs) • dermal application to mice does not affect tumour incidence in skin • no skin tumour development induced by OPP metabolites • tumours occur at high doses when sulfate and glucuronide conjugation pathways are saturated The SCCS has noted the NOAELs proposed by the Applicant for OPP and SOPP for systemic toxicity and carcinogenicity (for OPP: lowest NOAEL established at 39 and 49 mg/kg bw/day in males and females, respectively; for SOPP, an oral LOAEL of 224 mg/kg bw/day from a 104-week carcinogenicity study in rats has been considered as most appropriate and conservative value for PoD derivation. The Applicant applied a composite uncertainty factor of 10 to account for the extrapolation from LOAEL to NOAEL and study data quality resulting in a corrected PoD of 22.4 mg/kg bw/day. The SCCS, however, stated in SCCS/1555/15 that the 104-week carcinogenicity study in r","page":37,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_009"}
SCCS_vision_codex NOAEL =22.4 mg/kg bw/day rat oral 104-week developmental toxicity {"dose":"ion pathways are saturated The SCCS has noted the NOAELs proposed by the Applicant for OPP and SOPP for systemic toxicity and carcinogenicity (for OPP: lowest NOAEL established at 39 and 49 mg/kg bw/day in males and females, respectively; for SOPP, an oral LOAEL of 224 mg/kg bw/day from a 104-week carcinogenicity study in rats has been considere...","effect":"ion pathways are saturated The SCCS has noted the NOAELs proposed by the Applicant for OPP and SOPP for systemic toxicity and carcinogenicity (for OPP: lowest NOAEL established at 39 and 49 mg/kg bw/day in males and females, respectively; for SOPP, an oral LOAEL of 224 mg/kg bw/day from a 104-week carcinogenicity study in rats has been considered as most appropriate and conservative value for PoD derivation. The Applicant applied a composite uncertainty factor of 10 to account for the extrapolation from LOAEL to NOAEL and study data quality resulting in a corrected PoD of 22.4 mg/kg bw/day. The SCCS, however, stated in SCCS/1555/15 that the 104-week carcinogenicity study in rats performed with SOPP was not performed according to currently accepted standards but that it can be used as supporting information. Therefore, the SCCS will use the NOAEL of 25 mg/kg bw/d obtained from a developmental toxicity study for MoS calculation of both OPP and SOPP. This value is supported by the Applicant’s corrected PoD for SOPP of 22.4 mg/kg","page":37,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_010"}
SCCS_vision_codex NOAEL =25 mg/kg bw/d rabbit oral developmental developmental toxicity {"dose":"ts) An aggregate value of 17.4 g/d (269 mg/kg bw/d) for the amount of cosmetics applied daily is taken for MoS calculation according to the SCCS's Notes of Guidance 12th revision.","effect":"ts) An aggregate value of 17.4 g/d (269 mg/kg bw/d) for the amount of cosmetics applied daily is taken for MoS calculation according to the SCCS's Notes of Guidance 12th revision. Absorption through the skin DAp (%) = 45 % Amount of cosmetic product applied daily A (g/d) = 14.54 g/d Concentration of ingredient in finished product C (%) = 0.15 % Typical body weight of human = 60 kg Systemic exposure dose (SED) = A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60 = 0.163 mg/kg bw/d No adverse observed effect level NOAEL = 25 mg/kg bw/d (oral developmental toxicity study, rabbit) No adjustment, 100 % oral absorption Margin of Safety adjusted NOAEL/SED = 153 OPP in rinse-off products An aggregate value of 0.54 g/d (8.3 mg/kg bw/d) for the amount of cosmetics applied daily is taken for MoS calculation, according to the SCCS's Notes of Guidance 12th revision. Absorption through the skin DAp (%) = 45 % Amount of cosmetic product applied daily A (g/d) = 0.54 g/d Concentration of ingredient in finished product C (%) = 0.2 % Typica","page":41,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_012"}
SCCS_vision_codex NOAEL =100 % rabbit oral developmental developmental toxicity {"dose":"Absorption through the skin DAp (%) = 45 % Amount of cosmetic product applied daily A (g/d) = 14.54 g/d Concentration of ingredient in finished product C (%) = 0.15 % Typical body weight of human = 60 kg Systemic exposure dose (SED) = A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60 = 0.163 mg/kg bw/d No adverse observed effect level NOAEL = 25...","effect":"ing to the SCCS's Notes of Guidance 12th revision. Absorption through the skin DAp (%) = 45 % Amount of cosmetic product applied daily A (g/d) = 14.54 g/d Concentration of ingredient in finished product C (%) = 0.15 % Typical body weight of human = 60 kg Systemic exposure dose (SED) = A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60 = 0.163 mg/kg bw/d No adverse observed effect level NOAEL = 25 mg/kg bw/d (oral developmental toxicity study, rabbit) No adjustment, 100 % oral absorption Margin of Safety adjusted NOAEL/SED = 153 OPP in rinse-off products An aggregate value of 0.54 g/d (8.3 mg/kg bw/d) for the amount of cosmetics applied daily is taken for MoS calculation, according to the SCCS's Notes of Guidance 12th revision. Absorption through the skin DAp (%) = 45 % Amount of cosmetic product applied daily A (g/d) = 0.54 g/d Concentration of ingredient in finished product C (%) = 0.2 % Typical body weight of human = 60 kg Systemic exposure dose (SED) = A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60 = 0.0081 mg/kg bw","page":41,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_013"}
SCCS_vision_codex NOAEL =10000 mg/kg bw/day rat oral Sub-acute repeated dose toxicity {"dose":"Repeated dose toxicity Oral repeated dose toxicity studies Study type, Species Doses Key findings NOAEL or LOAEL Reference#/ KL rating OPP Sub-acute studies 1-month dietary study in rats (strain not specified) (5 females/ group); no guideline 0, 2000, 3000, 4000, 5000 and 10000 mg/kg bw/day At 2000 mg/kg bw/day and slight growth retardation was...","effect":"SCCS/1669/24 Final version Opinion on the safety of Biphenyl-2-ol and Sodium 2-biphenylolate (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 65 9.4 ANNEX 4. Repeated dose toxicity Oral repeated dose toxicity studies Study type, Species Doses Key findings NOAEL or LOAEL Reference#/ KL rating OPP Sub-acute studies 1-month dietary study in rats (strain not specified) (5 females/ group); no guideline 0, 2000, 3000, 4000, 5000 and 10000 mg/kg bw/day At 2000 mg/kg bw/day and slight growth retardation was observed, all of the other dose groups lost weight rapidly. LOAEL: 2000 mg/kg bw/day Hodge et al., 1952 in (ECHA RAC, 2022)/KL2 32-day gavage study in male rats (15 males/ group); no guideline 0, 2, 20 and 200 mg/kg bw/day No treatment related adverse effects on any of parame","page":65,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_023"}
SCCS_vision_codex NOAEL =200 mg/kg bw/day rat oral Sub-acute repeated dose toxicity {"dose":"rating OPP Sub-acute studies 1-month dietary study in rats (strain not specified) (5 females/ group); no guideline 0, 2000, 3000, 4000, 5000 and 10000 mg/kg bw/day At 2000 mg/kg bw/day and slight growth retardation was observed, all of the other dose groups lost weight rapidly.","effect":"rating OPP Sub-acute studies 1-month dietary study in rats (strain not specified) (5 females/ group); no guideline 0, 2000, 3000, 4000, 5000 and 10000 mg/kg bw/day At 2000 mg/kg bw/day and slight growth retardation was observed, all of the other dose groups lost weight rapidly. LOAEL: 2000 mg/kg bw/day Hodge et al., 1952 in (ECHA RAC, 2022)/KL2 32-day gavage study in male rats (15 males/ group); no guideline 0, 2, 20 and 200 mg/kg bw/day No treatment related adverse effects on any of parameters at any dose level. NOAEL: 200 mg/kg bw/day Macintosh, 1945 in (ECHA RAC, 2022)/KL2 13-day gavage study in New Zealand rabbits (2 females/ dose); similar to OECD 407 0, 100, 500 and 1000 mg/kg bw/day At 1000 mg/kg bw/day, ↓ final body weight, ↓ in food consumption was observed. At 500 mg/kg bw/day, changes in body weight, food consumption, absolute/relative, kidney and liver weight were observed. At 100 mg/kg bw/day, ↓ absolute/relative, liver weight. NOAEL: 100 mg/kg bw/day (ECHA, 2023b; ECHA RAC, 2022)/KL2 4-week gavage study in Beagle","page":65,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_024"}
SCCS_vision_codex NOAEL =100 mg/kg bw/day rabbit oral 13-day NOAEL study {"dose":"w/day No treatment related adverse effects on any of parameters at any dose level.","effect":"w/day No treatment related adverse effects on any of parameters at any dose level. NOAEL: 200 mg/kg bw/day Macintosh, 1945 in (ECHA RAC, 2022)/KL2 13-day gavage study in New Zealand rabbits (2 females/ dose); similar to OECD 407 0, 100, 500 and 1000 mg/kg bw/day At 1000 mg/kg bw/day, ↓ final body weight, ↓ in food consumption was observed. At 500 mg/kg bw/day, changes in body weight, food consumption, absolute/relative, kidney and liver weight were observed. At 100 mg/kg bw/day, ↓ absolute/relative, liver weight. NOAEL: 100 mg/kg bw/day (ECHA, 2023b; ECHA RAC, 2022)/KL2 4-week gavage study in Beagle dogs (2/sex/dose); no guideline 0, 100, 200, 300 (400 mg up to Day 5, lowered to 300 due to emesis) mg/kg bw/day 5 days/week for 4 weeks At 300 mg/kg bw/day, ↓ RBC, Hb, HCT and platelet was observed. At 200 mg/kg bw/day, dose-related emesis in all dogs, ↓ RBC and HCT count was observed. NOAEL: 100 mg/kg bw/day Cosse et al. in (EC, 2023; ECHA RAC, 2022)/KL2","page":65,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_025"}
SCCS_vision_codex NOAEL =2.5 % rat oral Sub-chronic repeated dose toxicity {"dose":"90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 66 Study type, Species Doses Key findings NOAEL or LOAEL Reference#/ KL rating Sub-chronic studie...","effect":"SCCS/1669/24 Final version Opinion on the safety of Biphenyl-2-ol and Sodium 2-biphenylolate (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 66 Study type, Species Doses Key findings NOAEL or LOAEL Reference#/ KL rating Sub-chronic studies 13-week dietary study in F344/DuCrj Rats (10/sex/group); similar to OECD TG 408 0, 0.156, 0.313, 0.625, 1.25, and 2.5% OPP equivalent to 0, 182, 391, 761, 1669, and 2798 mg/kg bw/day in males and 0, 202, 411, 803, 1650, and 3014 mg/kg bw/day in females At 2798/3014 mg/kg bw/day, ↓ body weight, terminal body weight, food and water consumption, changes in organ weight, and histopathological changes in the kidney and bladder, and ↓ Red Blood Count (RBC), Haemoglobin","page":66,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_027"}
SCCS_vision_codex NOAEL =761 mg/kg bw/day rat oral 3 months NOAEL study {"dose":"At 1669/1650 mg/kg bw/day, ↓ body weight, food, and water consumption, ↓Hb and MCH level and ↑ relative liver weight, relative kidney weight, absolute bladder weight and abnormal growth in the bladder mucosa was observed.","effect":"gical changes in the kidney and bladder, and ↓ Red Blood Count (RBC), Haemoglobin (Hb), Mean Corpuscular Volume (MCV), Mean Corpuscular Haemoglobin (MCH) and Mean Corpuscular Haemoglobin Concentration (MCHC) was observed. At 1669/1650 mg/kg bw/day, ↓ body weight, food, and water consumption, ↓Hb and MCH level and ↑ relative liver weight, relative kidney weight, absolute bladder weight and abnormal growth in the bladder mucosa was observed. At 761/ 803 mg/kg bw/day, changes in liver and kidney weight were observed. NOAEL: 761 mg/kg bw/day Iguchi et al., 1984 in (EC, 2023; ECHA, 2023b; ECHA RAC, 2022)/KL2 3 months dietary study (strain not specified) in rats (12/sex/group); no guideline 0, 100, 300, 1000 and 2000 mg/kg bw/day At 2000 mg/kg bw/day, slight growth retardation, ↑ liver, kidney and. in some rats (no numerical data available) At 1000 mg/kg bw/day, ↑ liver, kidney, and spleen weight in some rats (no numerical data available). NOAEL: 1000 mg/kg bw/day Hodge et al., 1952 in (ECHA RAC, 2022)/KL4 6 months gavage study (strain","page":66,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_028"}
SCCS_vision_codex NOAEL =1000 mg/kg bw/day rat oral 3 months NOAEL study {"dose":"At 761/ 803 mg/kg bw/day, changes in liver and kidney weight were observed.","effect":"a was observed. At 761/ 803 mg/kg bw/day, changes in liver and kidney weight were observed. NOAEL: 761 mg/kg bw/day Iguchi et al., 1984 in (EC, 2023; ECHA, 2023b; ECHA RAC, 2022)/KL2 3 months dietary study (strain not specified) in rats (12/sex/group); no guideline 0, 100, 300, 1000 and 2000 mg/kg bw/day At 2000 mg/kg bw/day, slight growth retardation, ↑ liver, kidney and. in some rats (no numerical data available) At 1000 mg/kg bw/day, ↑ liver, kidney, and spleen weight in some rats (no numerical data available). NOAEL: 1000 mg/kg bw/day Hodge et al., 1952 in (ECHA RAC, 2022)/KL4 6 months gavage study (strain not specified) in rats 0, 50, 100, 200 and 500 mg/kg bw/day 5 days/week At 500 mg/kg bw/day ↑ liver and kidney NOAEL: 200 mg/kg bw/day Hodge et al., 1952 in (ECHA, 2023b;","page":66,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_029"}
SCCS_vision_codex NOAEL =500 mg/kg bw/day dog oral Chronic NOAEL study {"dose":"Similar to OECD TG 409 0, 20, 200, and 500 mg/kg bw/day At 500 mg/kg bw/day, ↑ kidney weight in males (no numerical data) was observed.","effect":"SCCS/1669/24 Final version Opinion on the safety of Biphenyl-2-ol and Sodium 2-biphenylolate (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 67 Study type, Species Doses Key findings NOAEL or LOAEL Reference#/ KL rating (12/sex/group); no guideline weight (no numerical data available). ECHA RAC, 2022) /KL4 Chronic studies 1-year dietary study (strain not specified) in dogs (1- 2/sex/group); Similar to OECD TG 409 0, 20, 200, and 500 mg/kg bw/day At 500 mg/kg bw/day, ↑ kidney weight in males (no numerical data) was observed. NOAEL: 200 mg/kg bw/day Hodge et al., 1952 in (EC, 2023; ECHA, 2023b; ECHA RAC, 2022)/KL2 1 year gavage study in Beagle dogs (4/sex/group); Similar to OECD TG 409 0, 30, 100, and","page":67,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_031"}
SCCS_vision_codex NOAEL =4294 mg/kg bw/day mouse oral Sub-chronic repeated dose toxicity {"dose":"g bw/day) At 2000 mg/kg bw/day, an ↑ in dark- stained cells and a few mitoses were observed.","effect":"g bw/day) At 2000 mg/kg bw/day, an ↑ in dark- stained cells and a few mitoses were observed. The authors suggest that these changes are the prodromal stage of the tumours induced by SOPP after longer treatment periods. Only bladder examined (once/week by transmission electron microscopy (TEM). LOAEL: 2000 mg/kg bw/day Fukumori et al. in (SCCS, 2015)/KL2 Sub-chronic studies 13-week dietary study in B6C3F1 mice 0, 0.25, 0.5, 1.0, 2.0 and 4.0% (correspond- ding to At 5375/6349 mg/kg bw/day, ↓ body weight, ↓ mean food NOAEL: 3529 and 4294 mg/kg bw/day for males Shibata et al., 1981, 1985 in (SCCS, 2015)/KL2","page":67,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_035"}
SCCS_vision_codex NOAEL =5375 mg/kg bw/day rat oral 13-week NOAEL study {"dose":"90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 68 Study type, Species Doses Key findings NOAEL or LOAEL Reference#/ KL rating (10/sex/group); no...","effect":"SCCS/1669/24 Final version Opinion on the safety of Biphenyl-2-ol and Sodium 2-biphenylolate (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 68 Study type, Species Doses Key findings NOAEL or LOAEL Reference#/ KL rating (10/sex/group); no guideline weighted average doses of 0, 451, 902, 1581, 3529 and 5375 mg/kg bw/day in males and 0, 488, 976, 1926, 4294 and 6349 mg/kg bw/day in females, respectively) intake, ↑ urinary pH value and ↓ urine density. and females, respectively 13-week dietary study in F344 rats (10/sex/group); no guideline 0, 0.125, 0.25, 0.5, 1, 2 and 4% (corresponding to 0, 85, 177, 353, 706, 1384 and 2487 in males and 0, 87, 177, 352, 694, 1338 and 2431 mg/kg bw/day in females, res","page":68,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_036"}
SCCS_vision_codex NOAEL =353 mg/kg bw/day rat oral 13-week NOAEL study {"dose":"les, respectively) intake, ↑ urinary pH value and ↓ urine density. and females, respectively 13-week dietary study in F344 rats (10/sex/group); no guideline 0, 0.125, 0.25, 0.5, 1, 2 and 4% (corresponding to 0, 85, 177, 353, 706, 1384 and 2487 in males and 0, 87, 177, 352, 694, 1338 and 2431 mg/kg bw/day in females, respectively) At 2431/2487 mg...","effect":"les, respectively) intake, ↑ urinary pH value and ↓ urine density. and females, respectively 13-week dietary study in F344 rats (10/sex/group); no guideline 0, 0.125, 0.25, 0.5, 1, 2 and 4% (corresponding to 0, 85, 177, 353, 706, 1384 and 2487 in males and 0, 87, 177, 352, 694, 1338 and 2431 mg/kg bw/day in females, respectively) At 2431/2487 mg/kg bw/day, ↓ body weight, moderate pyelonephritis was observed. At 1338/1384 mg/kg bw/day, ↓ body weight was observed. At 694/706 mg/kg bw/day, ↓ body weight was observed. NOAEL: 353 mg/kg bw/day Iguchi et al., 1979 in (SCCS, 2015)/KL2 13-week dietary study in F344 rats (20/sex/group); no guideline 0, 0.625, 1.25, and 2.5% (correspond- ding to weighted average doses of 0, 625 1250 and 2500 in males and 0, 706, 1411 and 2823 mg/kg bw/day in females, respectively) At 2500/2823 mg/kg bw/day, ↓ body weight gain was observed. At 1250/1411 mg/kg bw/day, ↓ body weight gain was observed. NOAEL: 625 mg/kg bw/day Nakamura et al., 1981 in (SCCS, 2015)/KL2 90-day dietary study in male F344 rats (grou","page":68,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_037"}
SCCS_vision_codex NOAEL =625 mg/kg bw/day rat oral 13-week NOAEL study {"dose":"1338/1384 mg/kg bw/day, ↓ body weight was observed.","effect":"1338/1384 mg/kg bw/day, ↓ body weight was observed. At 694/706 mg/kg bw/day, ↓ body weight was observed. NOAEL: 353 mg/kg bw/day Iguchi et al., 1979 in (SCCS, 2015)/KL2 13-week dietary study in F344 rats (20/sex/group); no guideline 0, 0.625, 1.25, and 2.5% (correspond- ding to weighted average doses of 0, 625 1250 and 2500 in males and 0, 706, 1411 and 2823 mg/kg bw/day in females, respectively) At 2500/2823 mg/kg bw/day, ↓ body weight gain was observed. At 1250/1411 mg/kg bw/day, ↓ body weight gain was observed. NOAEL: 625 mg/kg bw/day Nakamura et al., 1981 in (SCCS, 2015)/KL2 90-day dietary study in male F344 rats (group not specified); no guideline 0 and 2% (correspond- ding to weighted average doses of 2000 mg/kg bw/day) At 2000 mg/kg bw/day, ↑ thickness of the bladder epithelium from Day 14 until end of study (classified as hyperplasia with accompanying increased frequency of cell infiltration) was observed. LOAEL: 2000 mg/kg bw/day Reitz et al., 1983 in (SCCS, 2015)/KL2","page":68,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_038"}
SCCS_vision_codex NOAEL =1865 mg/kg bw/day mouse dermal 4-week repeated dose toxicity {"dose":"90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 69 Dermal repeated dose toxicity studies Study type, Species Doses Key findings NOAEL or LOAEL Re...","effect":"SCCS/1669/24 Final version Opinion on the safety of Biphenyl-2-ol and Sodium 2-biphenylolate (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 69 Dermal repeated dose toxicity studies Study type, Species Doses Key findings NOAEL or LOAEL Reference#/ KL rating OPP 4-week dermal toxicity study in Swiss Webster CFW mice (10/sex/group); no guideline 0, 5.95, 11.4, 20.8, 35.7 and 55.5 mg / 0.1 mL acetone (corresponding to weighted average doses of 0, 383.1, 699.08, 1200 and 1865 mg/kg bw/day for males 0, 460.21, 839.70, 1441.20 and 2240.53 mg/kg bw/day for females respectively) 3 days/week Ulcerative lesions at the site of application were observed in all mice that received ≤20.8 mg; in 6/10 males and 9/10 females that received 11.4 mg; in 2/1","page":69,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_039"}
SCCS_vision_codex NOAEL =490 mg/kg bw/day rat oral - reproductive toxicity {"dose":"0, 40, 140 and 490 mg/kg bw/day Actual:","effect":"SCCS/1669/24 Final version Opinion on the safety of Biphenyl-2-ol and Sodium 2-biphenylolate (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 70 9.5 ANNEX 5. Reproductive and development toxicity Overview of reproductive toxicity studies Study type, Species Doses Critical effects NOAEL or LOAEL Reference#/ KL rating OPP Two- generation dietary reproductive toxicity study, CD Sprague- Dawley rats, (32-35/sex group) OECD TG 416 Nominal: 0, 40, 140 and 490 mg/kg bw/day Actual: 0, 35, 125 and 457 mg/kg bw/day for 2 generations Parental effects At 457 mg/kg bw/day, ↓ body weight, body weight gain and terminal body weight in males and females, ↑ relative weight of ovaries in females, ↑ Incidence of renal calculi and haemorrhage in males. ↑ Incidence of bladder calculi and urinary bladder transitional","page":70,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_042"}
SCCS_vision_codex NOAEL =35 mg/kg bw/day - - - reproductive toxicity {"dose":"ght of testes and kidney in males, ↑ Incidence of urinary bladder transitional cell hyperplasia in males At 125 mg/kg bw/day Parental effects ↑ in body weight gain and changes in food consumptions, ↑ relative weight of ovaries in females, ↑ Incidence of average number cells/layer in females and ↑ Incidence of bladder calculi in males were observed.","effect":"ght of testes and kidney in males, ↑ Incidence of urinary bladder transitional cell hyperplasia in males At 125 mg/kg bw/day Parental effects ↑ in body weight gain and changes in food consumptions, ↑ relative weight of ovaries in females, ↑ Incidence of average number cells/layer in females and ↑ Incidence of bladder calculi in males were observed. F1 effects ↑ Absolute weight of liver and kidney and testes in males, ↓ incidence of average number of cells/layers of urinary bladder were observed. At 35 mg/kg bw/day NOAEL (systemic toxicity): 35 mg/kg bw/day NOAEL (reproductive toxicity): 457 mg/kg bw/day NOAEL (offspring toxicity): 125 mg/kg bw/day Eigenberg et al., 1990 in (ECHA RAC, 2022; ECHA, 2023b; SCCS, 2015)/KL2","page":70,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_043"}
SCCS_vision_codex NOAEL =457 mg/kg bw/day - - - reproductive toxicity {"dose":"asia in males At 125 mg/kg bw/day Parental effects ↑ in body weight gain and changes in food consumptions, ↑ relative weight of ovaries in females, ↑ Incidence of average number cells/layer in females and ↑ Incidence of bladder calculi in males were observed.","effect":"asia in males At 125 mg/kg bw/day Parental effects ↑ in body weight gain and changes in food consumptions, ↑ relative weight of ovaries in females, ↑ Incidence of average number cells/layer in females and ↑ Incidence of bladder calculi in males were observed. F1 effects ↑ Absolute weight of liver and kidney and testes in males, ↓ incidence of average number of cells/layers of urinary bladder were observed. At 35 mg/kg bw/day NOAEL (systemic toxicity): 35 mg/kg bw/day NOAEL (reproductive toxicity): 457 mg/kg bw/day NOAEL (offspring toxicity): 125 mg/kg bw/day Eigenberg et al., 1990 in (ECHA RAC, 2022; ECHA, 2023b; SCCS, 2015)/KL2","page":70,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_045"}
SCCS_vision_codex NOAEL =92 mg/kg bw/day rat - chronic reproductive toxicity {"dose":"0, 20, 100 and 500 mg/kg bw/day Actual:","effect":"wley rats, (30/sex/group ) OECD TG 416 Nominal: 0, 20, 100 and 500 mg/kg bw/day Actual: 18/17, 93/92 and 459/457 mg/kg bw/day for males and females, respectively Parental effects At 459/457 mg/kg bw/day, no treatment-related increase in mortality, changes in body weight and terminal body weight, ↓ food consumption in males and females, ↑ incidence of histopathological alterations in males: in the urinary bladder; chronic Inflammation, nodular/papillary; simple hyperplasia, and the ureter dilatation and hyperplasia NOAEL (systemic and offspring toxicity): 92 mg/kg bw/day NOAEL (reproductive toxicity): 457 mg/kg bw/day Eigenberg and Lake 1995 in (ECHA RAC, 2022; ECHA, 2023b; SCCS, 2015)/KL1","page":71,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_047"}
SCCS_vision_codex NOAEL =2100 mg/kg bw/day mouse oral Developmental reproductive toxicity {"dose":"At 93/92 mg/kg bw/day, no statistically significant treatment related effects were observed in Parents and F1 Reproductive parameters At 459/457 mg/kg bw/day, Parents, F1 and F2 - ↑ fertility index during F2b generation, ↑ food consumption during gestation was observed However, this increase in the fertility index is considered an artifact due t...","effect":"ia, and kidney debris were observed. At 93/92 mg/kg bw/day, no statistically significant treatment related effects were observed in Parents and F1 Reproductive parameters At 459/457 mg/kg bw/day, Parents, F1 and F2 - ↑ fertility index during F2b generation, ↑ food consumption during gestation was observed However, this increase in the fertility index is considered an artifact due to the extremely low fertility index for the control group. Developmental toxicity studies Study type, Species Doses Critical effects NOAEL or LOAEL Reference#/ KL rating OPP Prenatal developmental toxicity via gavage in JCL- ICR mice, (21 females/group), similar to OCED TG 414 0, 1450, 1740 and 2100 mg/kg bw/day, GD 7-15 Maternal toxicity At 2100 mg/kg bw/day, ↑ mortality: 5 mice died on GD 8, 7 on GD 9 and 2 each on GD 11 and 12, ↓ body weight/body weight gain and ↓ in absolute/relative heart weight were observed. At 1740 mg/kg bw/day, ↑ LOAEL (maternal and developmental toxicity): 1450 mg/kg bw/day Ogata et al., 1978 in (EC, 2023; ECHA, 2023b; ECHA","page":72,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_050"}
SCCS_vision_codex NOAEL =1450 mg/kg bw/day mouse - - reproductive toxicity {"dose":"At 1450 mg/kg bw/day, ↑ mortality:","effect":"SCCS/1669/24 Final version Opinion on the safety of Biphenyl-2-ol and Sodium 2-biphenylolate (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 73 Study type, Species Doses Critical effects NOAEL or LOAEL Reference#/ KL rating mortality: 4 mice died on GD 7 and 1 each on GD 14, GD 15, and GD 16, ↓ body weight/body weight gain (no numerical data available), ↓ in absolute/relative heart weight and ↑ in relative liver weight. At 1450 mg/kg bw/day, ↑ mortality: 1 mouse died each on GD 11 and 15, 2 mice died on GD 16. ↑ in absolute/relative liver weight. Litter/reproductive data At 2100 mg/kg bw/day, ↓ foetal bodyweight, ↑ frequency of foetuses with cervical ribs, ↓ mean number of ossified left/right phalanges","page":73,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_051"}
SCCS_vision_codex NOAEL =300 mg/kg bw/day rat oral Prenatal developmental toxicity {"dose":"Prenatal developmental toxicity via gavage in SD rat, (25-35 females/group), similar to OCED TG 414 0, 100, 300 and 700 mg/kg bw/day, GD 6-15 Maternal toxicity At 700 mg/kg bw/day, ↓ body weight, body weight gain and absolute liver wight was observed.","effect":"↓ foetal body weight, ↑ frequency of foetuses with cervical ribs, ↓ mean number of ossified left/right phalanges in hindlegs, ↑ frequency of foetuses with externally visible malformations. Prenatal developmental toxicity via gavage in SD rat, (25-35 females/group), similar to OCED TG 414 0, 100, 300 and 700 mg/kg bw/day, GD 6-15 Maternal toxicity At 700 mg/kg bw/day, ↓ body weight, body weight gain and absolute liver wight was observed. At 300 mg/kg bw/day, decreased weight gain (not statistically significant) and NOAEL (maternal and evelopmental): 300 mg/kg bw/day (whereas SCCS has derived maternal NOAEL at 150 mg/kg bw/day) John et al., 1978 in (ECHA, 2023b)/KL2","page":73,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_052"}
SCCS_vision_codex NOAEL =150 mg/kg bw/day rat oral Prenatal developmental toxicity {"dose":"Prenatal developmental toxicity via gavage in SD rat, (25-35 females/group), similar to OCED TG 414 0, 100, 300 and 700 mg/kg bw/day, GD 6-15 Maternal toxicity At 700 mg/kg bw/day, ↓ body weight, body weight gain and absolute liver wight was observed.","effect":"fied left/right phalanges in hindlegs, ↑ frequency of foetuses with externally visible malformations. Prenatal developmental toxicity via gavage in SD rat, (25-35 females/group), similar to OCED TG 414 0, 100, 300 and 700 mg/kg bw/day, GD 6-15 Maternal toxicity At 700 mg/kg bw/day, ↓ body weight, body weight gain and absolute liver wight was observed. At 300 mg/kg bw/day, decreased weight gain (not statistically significant) and NOAEL (maternal and evelopmental): 300 mg/kg bw/day (whereas SCCS has derived maternal NOAEL at 150 mg/kg bw/day) John et al., 1978 in (ECHA, 2023b)/KL2","page":73,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_053"}
SCCS_vision_codex NOAEL =700 mg/kg bw/day rat oral Developmental developmental toxicity {"dose":"Developmental toxicity At 700 mg/kg bw/day, ↑Incidence of post- implantation loss in foetuses and litters were observed.","effect":"SCCS/1669/24 Final version Opinion on the safety of Biphenyl-2-ol and Sodium 2-biphenylolate (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 74 Study type, Species Doses Critical effects NOAEL or LOAEL Reference#/ KL rating reduced food consumption was observed. Developmental toxicity At 700 mg/kg bw/day, ↑Incidence of post- implantation loss in foetuses and litters were observed. Skeletal alteration: ↑Incidence foetuses with: Delayed ossification of sternebrae foetuses, skull foramen, skull bone island Prenatal developmental toxicity via gavage in Wistar rats, (11-20 females/group), similar to OCED TG 414 0, 150, 300, 600 and 1200 mg/kg bw/day, GD 6-15 Maternal toxicity At 1200 mg/kg bw/day, 10/11 dams","page":74,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_054"}
SCCS_vision_codex NOAEL =600 mg/kg bw/day rat oral Developmental developmental toxicity {"dose":"At 600 mg/kg bw/day, ↓ body weight gain, clinical signs such as pregnant rats fell into ataxia for several hours.","effect":"xia for several hours. At 600 mg/kg bw/day, ↓ body weight gain, clinical signs such as pregnant rats fell into ataxia for several hours. At 300 mg/kg bw/day, ↓ body weight gain, clinical signs such as pregnant rats fell into ataxia for several hours. Developmental toxicity At 600 mg/kg bw/day, ↑ percentage of foetal death, ↓ mean foetal weight, ↑ foetal incidence of malformations. At 300 mg/kg bw/day, ↑ foetal incidence of malformations NOAEL (maternal and developmental): 150 mg/kg bw/day Note: SCCS considered the NOAEL for developmental at 600 mg/kg bw/day) Kaneda et al., 1978 in (ECHA, 2023b; ECHA RAC, 2022; SCCS, 2015)/KL2 Range finding Prenatal developmental toxicity via gavage in New Zealand rabbits, (7 females/ group), no guideline 0, 250, 500 and 750 mg/ kg bw/day GD 7-19 Maternal toxicity At 750 mg/kg bw/day, mortality: nine rabbits died prior to study termination. Two rabbits (one at 500 and one at 750 mg/kg bw/day) were found withdepositions of the test material in the lungs. The remaining deaths were considered treatme","page":74,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_056"}
SCCS_vision_codex NOAEL =400 mg/ kg bw/ day mouse oral Prenatal developmental toxicity {"dose":"90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 76 Study type, Species Doses Critical effects NOAEL or LOAEL Reference#/ KL rating SOPP Prenatal...","effect":"SCCS/1669/24 Final version Opinion on the safety of Biphenyl-2-ol and Sodium 2-biphenylolate (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 76 Study type, Species Doses Critical effects NOAEL or LOAEL Reference#/ KL rating SOPP Prenatal developmental toxicity via gavage in JCL- ICR mice, (20 females/group), similar to OCED TG 414 0, 100, 200 and 400 mg/ kg bw/ day, GD 7-15 Maternal toxicity At 400 mg/kg bw/day, ↑ mortality (80% of unscheduled deaths), ↓ body weight and body weight gain, ↓ absolute weight of liver, heart, and spleen. At 200 mg/kg bw/day, ↑ mortality (20% of unscheduled deaths), ↓ body weight and body weight gain, ↑ relative lung weight at 100 mg/kg bw/day, ↓ body weight and body wei","page":76,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_061"}
SCCS_vision_codex NOAEL =269 mg/kg bw/day rat - 2-year carcinogenicity {"dose":"At 531 mg/kg bw/day, haematuria, ↓body weights, proliferative lesions in the urinary bladder, and moderate to severe nephritic lesions and urinary bladder tumours (papilloma and carcinoma, mainly transitional cell papilloma and carcinoma) were observed.","effect":"/day, ↑white blood cell count, haematuria, ↓body weights, proliferative lesions in the urinary bladder, and moderate to severe nephritic lesions and urinary bladder tumours (papilloma and carcinoma, mainly transitional cell papilloma and carcinoma). were observed. At 531 mg/kg bw/day, haematuria, ↓body weights, proliferative lesions in the urinary bladder, and moderate to severe nephritic lesions and urinary bladder tumours (papilloma and carcinoma, mainly transitional cell papilloma and carcinoma) were observed. NOAEL (carcinogenicity): 269 mg/kg bw/day Hiraga K., and Fujii T. 1984 in (EC, 2023; ECHA, 2023b; ECHA RAC, 2022; SCCS, 2015)/KL2 2-year combined chronic toxicity/ carcinogenicity study in CDF[F344]/BR rats 0, 800, 4000 and 8000/ 10000 ppm (equivalent to 0, 39/49, 200/248 and 402/647 mg/kg bw/day in At 402/647 mg/kg bw/day, ↑ incidence of urinary bladder masses, ↑ incidence of pitted zones in kidneys. Neoplastic changes such as ↑ incidence of transitional NOAEL (carcinogenicity and systemic toxicity): 39 and 49 mg/kg bw","page":93,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_067"}
SCCS_vision_codex NOAEL =248 mg/kg bw/day - - - NOAEL study {"dose":"At 200/248 mg/kg bw/day, neoplastic changes in the urinary bladder, such as ↑ incidence of transitional cell carcinomas in males, ↓ body weight, body weight gain, food consumption and food efficiency, ↑clinical signs and gross pathological signs of toxicity. and females, respectively SCCS, 2015;","effect":"SCCS/1669/24 Final version Opinion on the safety of Biphenyl-2-ol and Sodium 2-biphenylolate (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 94 Study type, Species Doses Key findings NOAEL/ LOAEL Reference / KL rating (50/sex/group); OECD TG 453 males/females, respectively cell carcinomas, ↑ incidence of papillomas in males was observed. Non-neoplastic changes in the urinary bladder and kidney were observed. At 200/248 mg/kg bw/day, neoplastic changes in the urinary bladder, such as ↑ incidence of transitional cell carcinomas in males, ↓ body weight, body weight gain, food consumption and food efficiency, ↑clinical signs and gross pathological signs of toxicity. and females, respectively SCCS, 2015;","page":94,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_069"}
SCCS_vision_codex NOAEL =3081 mg/kg bw/day - oral 96-week NOAEL study {"dose":"Systemically, slightly increased incidences of dilatation of the kidney tubules compared to acetone controls were observed in OPP treated animals.","effect":"effect. Systemically, slightly increased incidences of dilatation of the kidney tubules compared to acetone controls were observed in OPP treated animals. In males, a greater incidence of focal necrosis of the liver (of mild degree) was observed. OPP, alone or after tumour initiation with DMBA, did not increase the incidence of neoplastic skin lesions when applied dermally over two years National Toxicology Program, 1986 in (SCCS, 2015)/KL2 SOPP Oral 96-week dietary 0, 0.5, 1.0 and 2.0% At 3009/3081 mg/kg bw/day, NOAEL Hagiwara et","page":94,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_071"}
SCCS_vision_codex NOAEL =3009 mg/kg bw/day mouse - - NOAEL study {"dose":"90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 95 Study type, Species Doses Key findings NOAEL/ LOAEL Reference / KL rating study in B6C3F1 mice...","effect":"SCCS/1669/24 Final version Opinion on the safety of Biphenyl-2-ol and Sodium 2-biphenylolate (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 95 Study type, Species Doses Key findings NOAEL/ LOAEL Reference / KL rating study in B6C3F1 mice (50/sex/group); no guideline equivalent to 0, 591, 1451, and 3009 mg/kg bw/day for the males and 0, 480, 1464, and 3081 mg/kg bw/day for the females, respectively ↑hepatocellular carcinomas and calcification of the brain were observed. At 1451/1464 mg/kg bw/day ↑ haemangiosarcomas of the liver, ↑hepatocellular carcinomas were observed. At 480 mg/kg bw/day, cystic endometrial hyperplasia of the uterus in females was observed in females. Authors considered increased","page":95,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_072"}
SCCS_vision_codex NOAEL =125 mg/kg bw/day - oral 2-year carcinogenicity {"dose":"no guideline 0, 0.125, 0.25, 0.5, 1.0, 2.0 and 4.0% equivalent to 0, 62, 125, 250, 500, 1000 and 2000 mg/kg bw/dayk At 2000 mg/kg bw/day, ↑incidence of carcinoma in the renal papilla was observed.","effect":"no guideline 0, 0.125, 0.25, 0.5, 1.0, 2.0 and 4.0% equivalent to 0, 62, 125, 250, 500, 1000 and 2000 mg/kg bw/dayk At 2000 mg/kg bw/day, ↑incidence of carcinoma in the renal papilla was observed. At 1000 mg/kg bw/day, ↑ in the incidence of tumours of the urinary system and carcinosarcoma was observed. At 500 mg/kg bw/day, ↑in the incidence of tumours of the urinary system was observed. At 250 mg/kg bw/day, ↑in the incidence of tumours of the urinary system was observed. Haematuria was observed at all dose levels. NOAEL (carcinogenicity): 125 mg/kg bw/day LOAEL (systemic toxicity): 62 mg/kg bw/day Hiraga et al..., 1981 in (SCCS, 2015)/KL2 2-year dietary carcinogenicity 1st study: Males: 0, 7000 and 20000 ppm, At 466/770 mg/kg bw/day, ↑ focal atrophy of the LOAEL (carcinogenicity Hiraga et al..., 1983 in (SCCS,","page":95,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_073"}
SCCS_vision_codex NOAEL =770 mg/kg bw/day rat - - NOAEL study {"dose":"90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 96 Study type, Species Doses Key findings NOAEL/ LOAEL Reference / KL rating study in F344 rats (...","effect":"SCCS/1669/24 Final version Opinion on the safety of Biphenyl-2-ol and Sodium 2-biphenylolate (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 96 Study type, Species Doses Key findings NOAEL/ LOAEL Reference / KL rating study in F344 rats (50/sex/group); no guideline equivalent to 0, 270 and 770 mg/kg bw/day, respectively) and Females: 0, 5000 and 10000 ppm equivalent to 0, 224 and 466 mg/kg bw/day, respectively pancreas and ↑ incidences of interstitial nephritis of the kidney were observed. At 466/770 mg/kg bw/day in the kidneys, both non- neoplastic changes (interstitial nephritis and pyelonephritis) and neoplastic changes (transitional cell papilloma and carcinoma) occurred in low incidences in the","page":96,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_074"}
SCCS_vision_codex NOAEL =395 mg/kg bw/day rat - 2-year carcinogenicity {"dose":"95 mg/kg bw/day 2-year carcinogenicity study in male F344 rats (groups not specified); no guideline 0, 0.25, 0.5, 1.0 and 2.0% equivalent to approximately 0, 197, 395, 780 and 1579 mg/kg bw/dayl At 1579 mg/kg bw/day, hyperplasia of bladder was observed.","effect":"kidney, urinary bladder papillomas and/or carcinomas were observed. NOAEL (carcinogenicity and systemic toxicity): 95 mg/kg bw/day 2-year carcinogenicity study in male F344 rats (groups not specified); no guideline 0, 0.25, 0.5, 1.0 and 2.0% equivalent to approximately 0, 197, 395, 780 and 1579 mg/kg bw/dayl At 1579 mg/kg bw/day, hyperplasia of bladder was observed. Development of papilloma and carcinoma was observed after 36 weeks. At 780 mg/kg bw/day, development of simple hyperplasia from week 36 was observed. NOAEL (carcinogenicity and systemic toxicity): 395 mg/kg bw/day Fukushima et al..., 1982 in (SCCS, 2015)/KL4 112-week carcinogenicity 0, 2500, 5000, 10000, 15000 and 20000 ppm At 1500 mg/kg bw/day, transitional cell carcinoma NOAEL (carcinogenicity Niho et al..., 2002 in (SCCS,","page":96,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_076"}
SCCS_vision_codex NOAEL =1500 mg/kg bw/day - - 36 weeks carcinogenicity {"dose":".5, 1.0 and 2.0% equivalent to approximately 0, 197, 395, 780 and 1579 mg/kg bw/dayl At 1579 mg/kg bw/day, hyperplasia of bladder was observed.","effect":".5, 1.0 and 2.0% equivalent to approximately 0, 197, 395, 780 and 1579 mg/kg bw/dayl At 1579 mg/kg bw/day, hyperplasia of bladder was observed. Development of papilloma and carcinoma was observed after 36 weeks. At 780 mg/kg bw/day, development of simple hyperplasia from week 36 was observed. NOAEL (carcinogenicity and systemic toxicity): 395 mg/kg bw/day Fukushima et al..., 1982 in (SCCS, 2015)/KL4 112-week carcinogenicity 0, 2500, 5000, 10000, 15000 and 20000 ppm At 1500 mg/kg bw/day, transitional cell carcinoma NOAEL (carcinogenicity Niho et al..., 2002 in (SCCS,","page":96,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_077"}
SCCS_vision_codex NOAEL =2000 mg/kg bw/day rat dermal 52-week NOAEL study {"dose":"90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 97 Study type, Species Doses Key findings NOAEL/ LOAEL Reference / KL rating study in male F344 r...","effect":"SCCS/1669/24 Final version Opinion on the safety of Biphenyl-2-ol and Sodium 2-biphenylolate (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 97 Study type, Species Doses Key findings NOAEL/ LOAEL Reference / KL rating study in male F344 rats (50 /group) equivalent to approximately 250, 500, 1000, 1500 and 2000 mg/kg bw/day was observed in rats. At 1500 mg/kg bw/day and above, urinary bladder tumour formation was observed. and systemic toxicity): 1000 mg/kg bw/day 2015{Cal EPA, 2007 #4752)} /KL2 Dermal 52-week, two- stage mouse skin carcinogenesis study in female CD-1 mice Initiation: SOPP in DMSO (10 mg/100 µL) or DMBA ( (10 µg/100 µl) twice weekly for 5 weeks. Promotion: starting 1 week after last","page":97,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_078"}
SCCS_vision_codex NOAEL =224 mg/kg bw/day rat - - carcinogenicity {"dose":"In the first study, the LOAEL for systemic toxicity and carcinogenicity was established at 270 and 224 mg/kg bw/day in males and females, respectively.","effect":"isher Exact test, as calculated by DPR in Cal EPA, 2007: significant at p<0.05, p<0.01, p<0.001, respectively. +,++,+++ Cochran-Armitage trend test, as calculated by DPR in Cal EPA, 2007; significant at p<0.05, p<0.01, and p<0.001, respectively. Conclusion Under the study conditions, SOPP was assessed to be carcinogenic in Fischer 344 rats. In the first study, the LOAEL for systemic toxicity and carcinogenicity was established at 270 and 224 mg/kg bw/day in males and females, respectively. In the second study, the NOAEL for both systemic toxicity and carcinogenicity was established at 95 and 113 mg/kg bw/day in males and females, respectively. Note: The non-neoplastic changes such as interstitial nephritis and pyelonephritis and neoplastic changes such as transitional cell papilloma and carcinoma in the kidneys and carcinomas/papilloma induced in the bladder at 224/270 mg/kg bw/day did not reach statistical significance. However, in their evaluation, Cal EPA (2007) considered the observations to be treatment-related findings beca","page":102,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_081"}
SCCS_vision_codex NOAEL =65 - - - - NOAEL study {"effect":"Unlabeled table on page 65: Study type, | Doses | Key findings | NOAEL or | Reference#/ KL rating","page":65,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_082"}
SCCS_vision_codex NOAEL =66 - - - - NOAEL study {"effect":"Unlabeled table on page 66: Study type, Species | Doses | Key findings | NOAEL or LOAEL | Reference#/ KL rating","page":66,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_089"}
SCCS_vision_codex NOAEL =67 - - - - NOAEL study {"effect":"Unlabeled table on page 67: Study type, Species | Doses | Key findings | NOAEL or LOAEL | Reference#/ KL rating","page":67,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_096"}
SCCS_vision_codex NOAEL =4 % mouse oral 13-week NOAEL study {"dose":"13-week dietary study in B6C3F1 mice | 0, 0.25, 0.5, 1.0, 2.0 and 4.0% (correspond- ding to | At 5375/6349 mg/kg bw/day, ↓ body weight, ↓ mean food | NOAEL:","effect":"Unlabeled table on page 67: 13-week dietary study in B6C3F1 mice | 0, 0.25, 0.5, 1.0, 2.0 and 4.0% (correspond- ding to | At 5375/6349 mg/kg bw/day, ↓ body weight, ↓ mean food | NOAEL: 3529 and 4294 mg/kg bw/day for males | Shibata et al., 1981, 1985 in (SCCS, 2015)/KL2","page":67,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_099"}
SCCS_vision_codex NOAEL =68 - - - - NOAEL study {"effect":"Unlabeled table on page 68: Study type, Species | Doses | Key findings | NOAEL or LOAEL | Reference#/ KL rating","page":68,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_104"}
SCCS_vision_codex NOAEL =69 - - - - NOAEL study {"effect":"Unlabeled table on page 69: Study type, Species | Doses | Key findings | NOAEL or LOAEL","page":69,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_111"}
SCCS_vision_codex NOAEL =240 mg/kg bw/day mouse dermal 4-week NOAEL study {"dose":"4-week dermal toxicity study in Swiss Webster CFW mice (10/sex/group); no guideline | 0, 5.95, 11.4, 20.8, 35.7 and 55.5 mg / 0.1 mL acetone (corresponding to weighted average doses of 0, 383.1, 699.08, 1200 and 1865 mg/kg bw/day for males 0, 460.21, 839.70, 1441.20 and 2240.53 mg/kg bw/day for females respectively) 3 days/week | Ulcerative lesi...","effect":"Unlabeled table on page 69: 4-week dermal toxicity study in Swiss Webster CFW mice (10/sex/group); no guideline | 0, 5.95, 11.4, 20.8, 35.7 and 55.5 mg / 0.1 mL acetone (corresponding to weighted average doses of 0, 383.1, 699.08, 1200 and 1865 mg/kg bw/day for males 0, 460.21, 839.70, 1441.20 and 2240.53 mg/kg bw/day for females respectively) 3 days/week | Ulcerative lesions at the site of application were observed in all mice that received ≤20.8 mg; in 6/10 males and 9/10 females that received 11.4 mg; in 2/10 males and 7/10 females that received 5.95 mg, and in 1/10 male and 1/10 female of control group | LOAEL (dermal toxicity): 5.95 mg (equivalent to 200 / 240 mg/kg bw/day for males and females, respectively) | NTP, 1986 in ECHA RAC, 2022/KL2","page":69,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_113"}
SCCS_vision_codex NOAEL =70 - - - - NOAEL study {"effect":"Unlabeled table on page 70: Study type, Species | Doses | Critical effects | NOAEL or LOAEL | Reference#/ KL rating","page":70,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_115"}
SCCS_vision_codex NOAEL =71 - - - - NOAEL study {"effect":"Unlabeled table on page 71: Study type, Species | Doses | Critical effects | NOAEL or LOAEL | Reference#/ KL rating","page":71,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_118"}
SCCS_vision_codex NOAEL =72 - - - - NOAEL study {"effect":"Unlabeled table on page 72: Study type, Species | Doses | Critical effects | NOAEL or LOAEL | Reference#/ KL rating","page":72,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_121"}
SCCS_vision_codex NOAEL =73 - - - - NOAEL study {"effect":"Unlabeled table on page 73: Study type, Species | Doses | Critical effects | NOAEL or LOAEL | Reference#/ KL rating","page":73,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_123"}
SCCS_vision_codex NOAEL =74 - - - - NOAEL study {"effect":"Unlabeled table on page 74: Study type, Species | Doses | Critical effects | NOAEL or LOAEL | Reference#/ KL rating","page":74,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_126"}
SCCS_vision_codex NOAEL =1200 mg/kg bw/day rat oral Prenatal developmental toxicity {"dose":"Prenatal developmental toxicity via gavage in Wistar rats, (11-20 females/group), similar to OCED TG 414 | 0, 150, 300, 600 and 1200 mg/kg bw/day, GD 6-15 | Maternal toxicity At 1200 mg/kg bw/day, 10/11 dams died after 3-9 days of treatment, clinical signs such as pregnant rats fell into ataxia for several hours.","effect":"Unlabeled table on page 74: Prenatal developmental toxicity via gavage in Wistar rats, (11-20 females/group), similar to OCED TG 414 | 0, 150, 300, 600 and 1200 mg/kg bw/day, GD 6-15 | Maternal toxicity At 1200 mg/kg bw/day, 10/11 dams died after 3-9 days of treatment, clinical signs such as pregnant rats fell into ataxia for several hours. At 600 mg/kg bw/day, ↓ body weight gain, clinical signs such as pregnant rats fell into ataxia for several hours. At 300 mg/kg bw/day, ↓ body weight gain, clinical signs such as pregnant rats fell into ataxia for several hours. Developmental toxicity At 600 mg/kg bw/day, ↑ percentage of foetal death, ↓ mean foetal weight, ↑ foetal incidence of malformations. At 300 mg/kg bw/day, ↑ foetal incidence of malformations | NOAEL (maternal and developmental): 150 mg/kg bw/day Note: SCCS considered the NOAEL for developmental at 600 mg/kg bw/day) | Kaneda et al., 1978 in (ECHA, 2023b; ECHA RAC, 2022; SCCS, 2015)/KL2","page":74,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_127"}
SCCS_vision_codex NOAEL =750 mg/ kg bw/day rabbit oral Prenatal developmental toxicity {"dose":"Range finding Prenatal developmental toxicity via gavage in New Zealand rabbits, (7 females/ group), no guideline | 0, 250, 500 and 750 mg/ kg bw/day GD 7-19 | Maternal toxicity At 750 mg/kg bw/day, mortality: nine rabbits died prior to study termination.","effect":"Unlabeled table on page 74: Range finding Prenatal developmental toxicity via gavage in New Zealand rabbits, (7 females/ group), no guideline | 0, 250, 500 and 750 mg/ kg bw/day GD 7-19 | Maternal toxicity At 750 mg/kg bw/day, mortality: nine rabbits died prior to study termination. Two rabbits (one at 500 and one at 750 mg/kg bw/day) were found withdepositions of the test material in the lungs. The remaining deaths were considered treatment related. ↓ body weight and | LOAEL (maternal toxicity): 250 mg/kg bw/day; Developmental NOAEL cannot be established, since foetuses were not examined for skeletal, visceral, and external anomalies | Zablotny et al., 1991, in (ECHA RAC, 2022; SCCS, 2015) /KL2","page":74,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_128"}
SCCS_vision_codex NOAEL =75 - - - - NOAEL study {"effect":"Unlabeled table on page 75: Study type, Species | Doses | Critical effects | NOAEL or LOAEL | Reference#/ KL rating","page":75,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_131"}
SCCS_vision_codex NOAEL =76 - - - - NOAEL study {"effect":"Unlabeled table on page 76: Study type, Species | Doses | Critical effects | NOAEL or LOAEL | Reference#/ KL rating","page":76,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_134"}
SCCS_vision_codex NOAEL =93 - - - - NOAEL study {"effect":"Unlabeled table on page 93: Study type, Species | Doses | Key findings | NOAEL/ LOAEL | Reference / KL rating","page":93,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_136"}
SCCS_vision_codex NOAEL =10000 ppm rat - 2-year carcinogenicity {"dose":"2-year combined chronic toxicity/ carcinogenicity study in CDF[F344]/BR rats | 0, 800, 4000 and 8000/ 10000 ppm (equivalent to 0, 39/49, 200/248 and 402/647 mg/kg bw/day in | At 402/647 mg/kg bw/day, ↑ incidence of urinary bladder masses, ↑ incidence of pitted zones in kidneys.","effect":"Unlabeled table on page 93: 2-year combined chronic toxicity/ carcinogenicity study in CDF[F344]/BR rats | 0, 800, 4000 and 8000/ 10000 ppm (equivalent to 0, 39/49, 200/248 and 402/647 mg/kg bw/day in | At 402/647 mg/kg bw/day, ↑ incidence of urinary bladder masses, ↑ incidence of pitted zones in kidneys. Neoplastic changes such as ↑ incidence of transitional | NOAEL (carcinogenicity and systemic toxicity): 39 and 49 mg/kg bw/day in males | Wahle et al...,1996 in (ECHA, 2023b; ECHA RAC, 2022;","page":93,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_139"}
SCCS_vision_codex NOAEL =94 - - - - NOAEL study {"effect":"Unlabeled table on page 94: Study type, Species | Doses | Key findings | NOAEL/ LOAEL | Reference / KL rating","page":94,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_143"}
SCCS_vision_codex NOAEL =2 % rat - 2-year carcinogenicity {"dose":"Similar to OECD TG 453 | 0, 0.02, 0.2 and 2% equivalent to 0, 10, 100 and 1000 mg/kg bw/day | At 1000 mg/kg bw/day, ↓ body weight, ↑weight of testes and histopathological changes such as extensive renal damage, characterised by tubular dilation with varying degrees of acute and chronic inflammation was observed. | NOAEL:","effect":"Unlabeled table on page 94: 2-year combined chronic toxicity/ carcinogenicity study in weanling Rochester rats (25/sex/group); Similar to OECD TG 453 | 0, 0.02, 0.2 and 2% equivalent to 0, 10, 100 and 1000 mg/kg bw/day | At 1000 mg/kg bw/day, ↓ body weight, ↑weight of testes and histopathological changes such as extensive renal damage, characterised by tubular dilation with varying degrees of acute and chronic inflammation was observed. | NOAEL: 100 mg/kg bw/day | Hodge HC., et al... 1952 in (EC, 2023)/KL2","page":94,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_144"}
SCCS_vision_codex NOAEL =95 - - - - NOAEL study {"effect":"Unlabeled table on page 95: Study type, Species | Doses | Key findings | NOAEL/ LOAEL | Reference / KL rating","page":95,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_148"}
SCCS_vision_codex NOAEL =20000 ppm - oral 2-year carcinogenicity {"dose":"0, 7000 and 20000 ppm, | At 466/770 mg/kg bw/day, ↑ focal atrophy of the | LOAEL (carcinogenicity | Hiraga et al..., 1983 in (SCCS,","effect":"Unlabeled table on page 95: 2-year dietary carcinogenicity | 1st study: Males: 0, 7000 and 20000 ppm, | At 466/770 mg/kg bw/day, ↑ focal atrophy of the | LOAEL (carcinogenicity | Hiraga et al..., 1983 in (SCCS,","page":95,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_152"}
SCCS_vision_codex NOAEL =96 - - - - NOAEL study {"effect":"Unlabeled table on page 96: Study type, Species | Doses | Key findings | NOAEL/ LOAEL | Reference / KL rating","page":96,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_153"}
SCCS_vision_codex NOAEL =97 - - - - NOAEL study {"effect":"Unlabeled table on page 97: Study type, Species | Doses | Key findings | NOAEL/ LOAEL | Reference / KL rating","page":97,"pdf":"sccs_o_291.pdf","row_type":"noael_study","study_id":"sccs_o_291_noael_160"}
ToxRefDB_ToxRefDB_v3_pod.csv 13 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ToxRefDB_ToxRefDB_v3_pod.csv LEL =377 mg/kg bw/day rat (fischer; Fischer 344) oral 0 day to 90 day SUB study_id=752; toxval_study_source_id=studyid752_Adult_F0_M_systemic; toxval_effect_list=organ weight-kidney-relative to body weight|organ weight-liver-relative to body weight|organ weight-testes-relative to body weight|in life observation-body weight-body weight gain|in life observation-water consumption-water consumption|organ weight-brain-relative to body weight|in life observation-body weight-body weight|organ weight-urinary bladder-absolute|organ weight-lung-relative to body weight|organ weight-spleen-relative to body weight|organ weight-adrenal gland-relative to body weight|in life observation-food consumption-food consumption; dose_level=1; study_year=1981; study_citation=Nakamura, K.; Iguchi, S.; Hiraga, K. (1982; reformatted 1990) Dow Chemical U S A Phase 3 Reformat Of Mrid 40760207. Subacute Toxicity Of O-Phenylphenol By Food Administration To Male Rats. Prepared By Tokyo Metropolitan Research Lab. 25 P.; dsstox_substance_id=DTXSID2021151; admin_method=Feed; cas_source=toxval_ToxRefDB.xlsx:DTXSID; blob_url=https://clowder.edap-cluster.com/files/688cbadae4b02565bc3f8c07/blob; blob_sha256=69dd2da06ffc6a98a1bed684c347d8b2f31e6d35d607d4f2f83ebb6845a708d5
ToxRefDB_ToxRefDB_v3_pod.csv LEL =100 mg/kg bw/day rabbit (new zealand white; New Zealand White) oral 7 GD to 19 GD DEV study_id=753; toxval_study_source_id=studyid753_Adult_F0_F_systemic; toxval_effect_list=in life observation-clinical signs-discharge on cageboard|in life observation-clinical signs-urine, discoloration|pathology microscopic-stomach-hemorrhage|in life observation-clinical signs-abnormal feces|in life observation-mortality-mortality|pathology microscopic-stomach-ulcer|in life observation-clinical signs-perineal soiling|pathology microscopic-kidney-inflammation|pathology microscopic-kidney-degeneration; dose_level=2; study_year=1991; study_citation=Zablotny, C.; Breslin, W.; Kociba, R. (1991) Ortho-Phenylphenol (OPP): Gavage Teratology Study In New Zealand White Rabbits. Lab Project Number: K-001024-045. Unpublished Study Prepared By Dow Chemical Co., Health and Env. Sciences. 309 P.; dsstox_substance_id=DTXSID2021151; admin_method=Gavage/Intubation; cas_source=toxval_ToxRefDB.xlsx:DTXSID; blob_url=https://clowder.edap-cluster.com/files/688cbadae4b02565bc3f8c07/blob; blob_sha256=69dd2da06ffc6a98a1bed684c347d8b2f31e6d35d607d4f2f83ebb6845a708d5
ToxRefDB_ToxRefDB_v3_pod.csv LEL =300 mg/kg bw/day rat (sprague dawley; Sprague Dawley) oral 6 GD to 15 GD DEV study_id=755; toxval_study_source_id=studyid755_Adult_F0_F_systemic; toxval_effect_list=in life observation-food consumption-food efficiency|in life observation-food consumption-food consumption|in life observation-body weight-body weight gain|organ weight-liver-absolute|organ weight-liver-relative to body weight; dose_level=2; study_year=1978; study_citation=John, J.; Murray, F.; Crawford, A. et al. (1978) Phase 3 Reformat Of MRIDs 00067616 and 00164362: The Effect(s) Of Orally Administered Orthophenylphenol On Rat Embryonal And Fetal Development: Project Het-K-0001024-33(R). *see study comment*; dsstox_substance_id=DTXSID2021151; admin_method=Gavage/Intubation; cas_source=toxval_ToxRefDB.xlsx:DTXSID; blob_url=https://clowder.edap-cluster.com/files/688cbadae4b02565bc3f8c07/blob; blob_sha256=69dd2da06ffc6a98a1bed684c347d8b2f31e6d35d607d4f2f83ebb6845a708d5
ToxRefDB_ToxRefDB_v3_pod.csv LEL >700 mg/kg bw/day rat (sprague dawley; Sprague Dawley) oral 6 GD to 15 GD DEV study_id=755; toxval_study_source_id=studyid755_Fetal_Fetal_MF_NA; dose_level=3; study_year=1978; study_citation=John, J.; Murray, F.; Crawford, A. et al. (1978) Phase 3 Reformat Of MRIDs 00067616 and 00164362: The Effect(s) Of Orally Administered Orthophenylphenol On Rat Embryonal And Fetal Development: Project Het-K-0001024-33(R). *see study comment*; dsstox_substance_id=DTXSID2021151; admin_method=Gavage/Intubation; cas_source=toxval_ToxRefDB.xlsx:DTXSID; blob_url=https://clowder.edap-cluster.com/files/688cbadae4b02565bc3f8c07/blob; blob_sha256=69dd2da06ffc6a98a1bed684c347d8b2f31e6d35d607d4f2f83ebb6845a708d5
ToxRefDB_ToxRefDB_v3_pod.csv LEL =140 mg/kg bw/day rat (sprague dawley; Sprague Dawley (CD)) oral 15 weeks (premating) to 2 generation MGR study_id=756; toxval_study_source_id=studyid756_Adult_F0_F_systemic; toxval_effect_list=pathology microscopic-urinary bladder-cellular alteration|in life observation-body weight-body weight|pathology microscopic-urinary bladder-hyperplasia; dose_level=2; study_year=1990; study_citation=Eigenberg, D. (1990) Two-Generation Dietary Reproduction Study in Rats Using Orthophenyl Phenol: Lab Project Number: 85-671-02. Unpublished study prepared by Mobay Corp. 2696 p.; dsstox_substance_id=DTXSID2021151; admin_method=Feed; cas_source=toxval_ToxRefDB.xlsx:DTXSID; blob_url=https://clowder.edap-cluster.com/files/688cbadae4b02565bc3f8c07/blob; blob_sha256=69dd2da06ffc6a98a1bed684c347d8b2f31e6d35d607d4f2f83ebb6845a708d5
ToxRefDB_ToxRefDB_v3_pod.csv LEL =490 mg/kg bw/day rat (sprague dawley; Sprague Dawley (CD)) oral 15 weeks (premating) to 2 generation MGR study_id=756; toxval_study_source_id=studyid756_Adult_F1_F_systemic; toxval_effect_list=in life observation-body weight-body weight; dose_level=3; study_year=1990; study_citation=Eigenberg, D. (1990) Two-Generation Dietary Reproduction Study in Rats Using Orthophenyl Phenol: Lab Project Number: 85-671-02. Unpublished study prepared by Mobay Corp. 2696 p.; dsstox_substance_id=DTXSID2021151; admin_method=Feed; cas_source=toxval_ToxRefDB.xlsx:DTXSID; blob_url=https://clowder.edap-cluster.com/files/688cbadae4b02565bc3f8c07/blob; blob_sha256=69dd2da06ffc6a98a1bed684c347d8b2f31e6d35d607d4f2f83ebb6845a708d5
ToxRefDB_ToxRefDB_v3_pod.csv LEL =250 mg/kg bw/day mouse (b6c3f1; B6C3F1) oral 0 day to 24 month CHR study_id=759; toxval_study_source_id=studyid759_Adult_F0_F_systemic; toxval_effect_list=pathology microscopic-liver-accentuated lobular pattern|urinalysis-specific gravity/osmolality-specific gravity/osmolality|organ weight-kidney-relative to body weight|organ weight-liver-relative to body weight|organ weight-brain-relative to body weight|organ weight-liver-absolute|in life observation-body weight-body weight gain|organ weight-brain-absolute|organ weight-adrenal gland-relative to body weight; dose_level=1; study_year=1995; study_citation=Quast, J.; Mcguirk, R. (1995) Ortho-Phenylphenol: Two-Year Dietary Chronic Toxicity/Oncogenicity Study In B6C3F1 Mice: Lab Project Number: K-001024-047. Unpublished Study Prepared By The Dow Chemical Co. 1089 P.; dsstox_substance_id=DTXSID2021151; admin_method=Feed; cas_source=toxval_ToxRefDB.xlsx:DTXSID; blob_url=https://clowder.edap-cluster.com/files/688cbadae4b02565bc3f8c07/blob; blob_sha256=69dd2da06ffc6a98a1bed684c347d8b2f31e6d35d607d4f2f83ebb6845a708d5
ToxRefDB_ToxRefDB_v3_pod.csv LOAEL =763 mg/kg bw/day rat (fischer; Fischer 344) oral 0 day to 90 day SUB study_id=752; toxval_study_source_id=studyid752_Adult_F0_M_systemic; toxval_effect_list=in life observation-body weight-body weight gain|in life observation-body weight-body weight; dose_level=2; study_year=1981; study_citation=Nakamura, K.; Iguchi, S.; Hiraga, K. (1982; reformatted 1990) Dow Chemical U S A Phase 3 Reformat Of Mrid 40760207. Subacute Toxicity Of O-Phenylphenol By Food Administration To Male Rats. Prepared By Tokyo Metropolitan Research Lab. 25 P.; dsstox_substance_id=DTXSID2021151; admin_method=Feed; cas_source=toxval_ToxRefDB.xlsx:DTXSID; blob_url=https://clowder.edap-cluster.com/files/688cbadae4b02565bc3f8c07/blob; blob_sha256=69dd2da06ffc6a98a1bed684c347d8b2f31e6d35d607d4f2f83ebb6845a708d5
ToxRefDB_ToxRefDB_v3_pod.csv LOAEL =250 mg/kg bw/day rabbit (new zealand white; New Zealand White) oral 7 GD to 19 GD DEV study_id=753; toxval_study_source_id=studyid753_Adult_F0_F_systemic; toxval_effect_list=in life observation-clinical signs-abnormal feces|in life observation-mortality-mortality|in life observation-clinical signs-perineal soiling; dose_level=3; study_year=1991; study_citation=Zablotny, C.; Breslin, W.; Kociba, R. (1991) Ortho-Phenylphenol (OPP): Gavage Teratology Study In New Zealand White Rabbits. Lab Project Number: K-001024-045. Unpublished Study Prepared By Dow Chemical Co., Health and Env. Sciences. 309 P.; dsstox_substance_id=DTXSID2021151; admin_method=Gavage/Intubation; cas_source=toxval_ToxRefDB.xlsx:DTXSID; blob_url=https://clowder.edap-cluster.com/files/688cbadae4b02565bc3f8c07/blob; blob_sha256=69dd2da06ffc6a98a1bed684c347d8b2f31e6d35d607d4f2f83ebb6845a708d5
ToxRefDB_ToxRefDB_v3_pod.csv NEL >0 mg/kg bw/day rat (fischer; Fischer 344) oral 0 day to 90 day SUB study_id=752; toxval_study_source_id=studyid752_Adult_F0_M_systemic; toxval_effect_list=organ weight-adrenal gland-relative to body weight|organ weight-brain-relative to body weight|organ weight-liver-relative to body weight|organ weight-urinary bladder-absolute|in life observation-body weight-body weight|organ weight-lung-relative to body weight|in life observation-water consumption-water consumption|organ weight-spleen-relative to body weight|organ weight-kidney-relative to body weight|in life observation-food consumption-food consumption|organ weight-testes-relative to body weight|in life observation-body weight-body weight gain; dose_level=0; study_year=1981; study_citation=Nakamura, K.; Iguchi, S.; Hiraga, K. (1982; reformatted 1990) Dow Chemical U S A Phase 3 Reformat Of Mrid 40760207. Subacute Toxicity Of O-Phenylphenol By Food Administration To Male Rats. Prepared By Tokyo Metropolitan Research Lab. 25 P.; dsstox_substance_id=DTXSID2021151; admin_method=Feed; cas_source=toxval_ToxRefDB.xlsx:DTXSID; blob_url=https://clowder.edap-cluster.com/files/688cbadae4b02565bc3f8c07/blob; blob_sha256=69dd2da06ffc6a98a1bed684c347d8b2f31e6d35d607d4f2f83ebb6845a708d5
ToxRefDB_ToxRefDB_v3_pod.csv NEL =25 mg/kg bw/day rabbit (new zealand white; New Zealand White) oral 7 GD to 19 GD DEV study_id=753; toxval_study_source_id=studyid753_Adult_F0_F_systemic; toxval_effect_list=in life observation-clinical signs-abnormal feces|in life observation-clinical signs-urine, discoloration|pathology microscopic-stomach-hemorrhage|pathology microscopic-kidney-degeneration|in life observation-clinical signs-discharge on cageboard|pathology microscopic-stomach-ulcer|in life observation-clinical signs-perineal soiling|in life observation-mortality-mortality|pathology microscopic-kidney-inflammation; dose_level=1; study_year=1991; study_citation=Zablotny, C.; Breslin, W.; Kociba, R. (1991) Ortho-Phenylphenol (OPP): Gavage Teratology Study In New Zealand White Rabbits. Lab Project Number: K-001024-045. Unpublished Study Prepared By Dow Chemical Co., Health and Env. Sciences. 309 P.; dsstox_substance_id=DTXSID2021151; admin_method=Gavage/Intubation; cas_source=toxval_ToxRefDB.xlsx:DTXSID; blob_url=https://clowder.edap-cluster.com/files/688cbadae4b02565bc3f8c07/blob; blob_sha256=69dd2da06ffc6a98a1bed684c347d8b2f31e6d35d607d4f2f83ebb6845a708d5
ToxRefDB_ToxRefDB_v3_pod.csv NEL =100 mg/kg bw/day rat (sprague dawley; Sprague Dawley) oral 6 GD to 15 GD DEV study_id=755; toxval_study_source_id=studyid755_Adult_F0_F_systemic; toxval_effect_list=in life observation-food consumption-food efficiency|organ weight-liver-relative to body weight|organ weight-liver-absolute|in life observation-body weight-body weight gain|in life observation-food consumption-food consumption; dose_level=1; study_year=1978; study_citation=John, J.; Murray, F.; Crawford, A. et al. (1978) Phase 3 Reformat Of MRIDs 00067616 and 00164362: The Effect(s) Of Orally Administered Orthophenylphenol On Rat Embryonal And Fetal Development: Project Het-K-0001024-33(R). *see study comment*; dsstox_substance_id=DTXSID2021151; admin_method=Gavage/Intubation; cas_source=toxval_ToxRefDB.xlsx:DTXSID; blob_url=https://clowder.edap-cluster.com/files/688cbadae4b02565bc3f8c07/blob; blob_sha256=69dd2da06ffc6a98a1bed684c347d8b2f31e6d35d607d4f2f83ebb6845a708d5
ToxRefDB_ToxRefDB_v3_pod.csv NEL =40 mg/kg bw/day rat (sprague dawley; Sprague Dawley (CD)) oral 15 weeks (premating) to 2 generation MGR study_id=756; toxval_study_source_id=studyid756_Adult_F0_F_systemic; toxval_effect_list=in life observation-body weight-body weight|pathology microscopic-urinary bladder-cellular alteration|pathology microscopic-urinary bladder-hyperplasia; dose_level=1; study_year=1990; study_citation=Eigenberg, D. (1990) Two-Generation Dietary Reproduction Study in Rats Using Orthophenyl Phenol: Lab Project Number: 85-671-02. Unpublished study prepared by Mobay Corp. 2696 p.; dsstox_substance_id=DTXSID2021151; admin_method=Feed; cas_source=toxval_ToxRefDB.xlsx:DTXSID; blob_url=https://clowder.edap-cluster.com/files/688cbadae4b02565bc3f8c07/blob; blob_sha256=69dd2da06ffc6a98a1bed684c347d8b2f31e6d35d607d4f2f83ebb6845a708d5
ToxValDB_ECOTOX 7 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ToxValDB_ECOTOX LOEL =2000 mg/kg bw/day Mouse oral acute; 1 days acute LONG_REF=Mutat. Res.395(2/3): 189-198 Sasaki,Y.F., A. Saga, M. Akasaka, K. Yoshida, E. Nishidate, Y.Q. Su, N. Matsusaka, and S. Tsuda In Vivo Genotoxicity of Ortho-Phenylphenol, Biphenyl, and Thiabendazole Detected in Multiple Mouse Organs by the Alkaline Single Cell Gel Electrophoresis Assay 1997; TITLE=In Vivo Genotoxicity of Ortho-Phenylphenol, Biphenyl, and Thiabendazole Detected in Multiple Mouse Organs by the Alkaline Single Cell Gel Electrophoresis Assay; AUTHOR=Sasaki,Y.F., A. Saga, M. Akasaka, K. Yoshida, E. Nishidate, Y.Q. Su, N. Matsusaka, and S. Tsuda; DOI=10.1016/s1383-5718(97)00168-x; QUALITY=Control type: Carrier or solvent control; EXTERNAL_SOURCE_ID=95361; EXTERNAL_SOURCE_ID_DESC=ECOTOX Reference Number; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759bce8e4b0a7c65d37bc5f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://cfpub.epa.gov/ecotox/; YEAR=1997; ORIGINAL_YEAR=1997; TOXICOLOGICAL_EFFECT=Genetics: Damage; TOXICOLOGICAL_EFFECT_CATEGORY=other; STUDY_GROUP=ECOTOX:15595032:M:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=4ace0dc5f4e412cb24c65d32410a3ec9
ToxValDB_ECOTOX LOEL =2 % diet Rat oral chronic; 168 days chronic LONG_REF=Cancer Lett.48(1): 19-28 Shibata,M.A., H. Tanaka, M. Yamada, S. Tamano, and S. Fukushima Proliferative Response of Renal Pelvic Epithelium in Rats to Oral Administration of Ortho-Phenylphenol, Sodium Ortho-Phenylphenate and Diphenyl 1989; TITLE=Proliferative Response of Renal Pelvic Epithelium in Rats to Oral Administration of Ortho-Phenylphenol, Sodium Ortho-Phenylphenate and Diphenyl; AUTHOR=Shibata,M.A., H. Tanaka, M. Yamada, S. Tamano, and S. Fukushima; DOI=10.1016/0304-3835(89)90198-5; QUALITY=Control type: Concurrent control; EXTERNAL_SOURCE_ID=96226; EXTERNAL_SOURCE_ID_DESC=ECOTOX Reference Number; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759bce8e4b0a7c65d37bc5f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://cfpub.epa.gov/ecotox/; YEAR=1989; ORIGINAL_YEAR=1989; TOXICOLOGICAL_EFFECT=Genetics: DNA synthesis rate|Growth: Weight; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|other; STUDY_GROUP=ECOTOX:15599614:M:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=da703b8d02e579ee447e59ad31052880
ToxValDB_ECOTOX LOEL =300 mg/kg bw/day Rat oral short-term; 10 days short-term LONG_REF=- | J. Pestic. Sci.3:365-370 Kaneda,M., S. Teramoto, A. Shingu, and Y. Shirasu Teratogenicity and Dominant-Lethal Studies with o-Phenylphenol 1978; TITLE=Teratogenicity and Dominant-Lethal Studies with o-Phenylphenol; AUTHOR=Kaneda,M., S. Teramoto, A. Shingu, and Y. Shirasu; QUALITY=Control type: Concurrent control; EXTERNAL_SOURCE_ID=35292; EXTERNAL_SOURCE_ID_DESC=ECOTOX Reference Number; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759bce8e4b0a7c65d37bc5f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://cfpub.epa.gov/ecotox/; YEAR=1978; ORIGINAL_YEAR=1978; TOXICOLOGICAL_EFFECT=Growth: Weight gain; TOXICOLOGICAL_EFFECT_CATEGORY=body weight; STUDY_GROUP=ECOTOX:15613586:F:-adult; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; Source overall passed QC, and this record was expert reviewed and revised from ECOTOX source; QC_STATUS=pass; SOURCE_HASH=0a05aa302b8ded8b4db4472b879b9233
ToxValDB_ECOTOX NOEL =2 % Rat oral subchronic; 56 days subchronic LONG_REF=Toxicol. Appl. Pharmacol.99(1): 37-49 Shibata,M.A., M. Yamada, H. Tanaka, M. Kagawa, and S. Fukushima Changes in Urine Composition, Bladder Epithelial Morphology, and DNA Synthesis in Male F344 Rats in Response to Ingestion of Bladder Tumor Promoters 1989; TITLE=Changes in Urine Composition, Bladder Epithelial Morphology, and DNA Synthesis in Male F344 Rats in Response to Ingestion of Bladder Tumor Promoters; AUTHOR=Shibata,M.A., M. Yamada, H. Tanaka, M. Kagawa, and S. Fukushima; DOI=10.1016/0041-008x(89)90109-9; QUALITY=Control type: Multiple entries; EXTERNAL_SOURCE_ID=106692; EXTERNAL_SOURCE_ID_DESC=ECOTOX Reference Number; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759bce8e4b0a7c65d37bc5f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://cfpub.epa.gov/ecotox/; YEAR=1989; ORIGINAL_YEAR=1989; TOXICOLOGICAL_EFFECT=Biochemistry: pH|Genetics: DNA synthesis rate; TOXICOLOGICAL_EFFECT_CATEGORY=other|urinalysis; STUDY_GROUP=ECOTOX_dup_EPA ORD_15609983_15609984:M:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=586be227872d146791bfdd5325b149c7
ToxValDB_ECOTOX NOEL =150 mg/kg bw/day Mouse oral short-term; 10 days short-term LONG_REF=- | J. Pestic. Sci.3:365-370 Kaneda,M., S. Teramoto, A. Shingu, and Y. Shirasu Teratogenicity and Dominant-Lethal Studies with o-Phenylphenol 1978; TITLE=Teratogenicity and Dominant-Lethal Studies with o-Phenylphenol; AUTHOR=Kaneda,M., S. Teramoto, A. Shingu, and Y. Shirasu; QUALITY=Control type: Concurrent control; EXTERNAL_SOURCE_ID=35292; EXTERNAL_SOURCE_ID_DESC=ECOTOX Reference Number; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759bce8e4b0a7c65d37bc5f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://cfpub.epa.gov/ecotox/; YEAR=1978; ORIGINAL_YEAR=1978; TOXICOLOGICAL_EFFECT=Material body weight gain; TOXICOLOGICAL_EFFECT_CATEGORY=body weight; STUDY_GROUP=ECOTOX:15613426:F:-adult; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; Source overall passed QC, and this record was expert reviewed and revised from ECOTOX source; QC_STATUS=pass; SOURCE_HASH=9250b3f31bcaf169662e3ecd7029616d
ToxValDB_ECOTOX NOEL =500 mg/kg bw/day Mouse oral short-term; 5 days developmental LONG_REF=- | J. Pestic. Sci.3:365-370 Kaneda,M., S. Teramoto, A. Shingu, and Y. Shirasu Teratogenicity and Dominant-Lethal Studies with o-Phenylphenol 1978; TITLE=Teratogenicity and Dominant-Lethal Studies with o-Phenylphenol; AUTHOR=Kaneda,M., S. Teramoto, A. Shingu, and Y. Shirasu; QUALITY=Control type: Concurrent control; EXTERNAL_SOURCE_ID=35292; EXTERNAL_SOURCE_ID_DESC=ECOTOX Reference Number; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759bce8e4b0a7c65d37bc5f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://cfpub.epa.gov/ecotox/; YEAR=1978; ORIGINAL_YEAR=1978; TOXICOLOGICAL_EFFECT=Genetics: Dominant lethal mutations; TOXICOLOGICAL_EFFECT_CATEGORY=other; STUDY_GROUP=ECOTOX:15613427:M:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; Source overall passed QC, and this record was expert reviewed and revised from ECOTOX source; QC_STATUS=pass; SOURCE_HASH=465474ae15945053ea03a498113965fd
ToxValDB_ECOTOX NOEL =300 mg/kg bw/day Rat oral short-term; 10 days reproduction developmental LONG_REF=- | J. Pestic. Sci.3:365-370 Kaneda,M., S. Teramoto, A. Shingu, and Y. Shirasu Teratogenicity and Dominant-Lethal Studies with o-Phenylphenol 1978; TITLE=Teratogenicity and Dominant-Lethal Studies with o-Phenylphenol; AUTHOR=Kaneda,M., S. Teramoto, A. Shingu, and Y. Shirasu; QUALITY=Control type: Concurrent control; EXTERNAL_SOURCE_ID=35292; EXTERNAL_SOURCE_ID_DESC=ECOTOX Reference Number; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759bce8e4b0a7c65d37bc5f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://cfpub.epa.gov/ecotox/; YEAR=1978; ORIGINAL_YEAR=1978; TOXICOLOGICAL_EFFECT=Fetus: Growth: Weight | Fetus: Morphology: External, skeletal, and internal abnormalities; TOXICOLOGICAL_EFFECT_CATEGORY=development; STUDY_GROUP=ECOTOX:15613587:M/F:-fetus; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; Source overall passed QC, and this record was expert reviewed and revised from ECOTOX source; QC_STATUS=pass; SOURCE_HASH=38ba2be1c58182567716a5bf8e5c57ea
ToxValDB_EFSA 3 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ToxValDB_EFSA NOAEL =500 mg/kg bw/day Rat oral - reproduction developmental LONG_REF=EFSA (2009). Peer review of the pesticide risk assessment of the active substance 2-phenylphenol. doi:10.2903/j.efsa.2009.217r.; TITLE=Peer review of the pesticide risk assessment of the active substance 2-phenylphenol; AUTHOR=EFSA; DOI=doi:10.2903/j.efsa.2009.217r; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/65201d30e4b0f0a60ddd1165; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://zenodo.org/record/5076033#.Y9fEoXbMI2z; YEAR=2009; ORIGINAL_YEAR=2009; STUDY_GROUP=EFSA:15617593:-:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_ae294a2294bffc4709b2a1fb4d0f2ee3
ToxValDB_EFSA NOAEL =100 mg/kg bw/day Rabbit oral - reproduction developmental LONG_REF=EFSA (2009). Peer review of the pesticide risk assessment of the active substance 2-phenylphenol. doi:10.2903/j.efsa.2009.217r.; TITLE=Peer review of the pesticide risk assessment of the active substance 2-phenylphenol; AUTHOR=EFSA; DOI=doi:10.2903/j.efsa.2009.217r; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/65201d30e4b0f0a60ddd1165; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://zenodo.org/record/5076033#.Y9fEoXbMI2z; YEAR=2009; ORIGINAL_YEAR=2009; TOXICOLOGICAL_EFFECT=body weight; TOXICOLOGICAL_EFFECT_CATEGORY=body weight; STUDY_GROUP=EFSA:15617594:-:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_4e86175022c56810337452a86874ecb6
ToxValDB_EFSA NOAEL =39 mg/kg bw/day Rat oral chronic; 2 years chronic LONG_REF=EFSA (2009). Peer review of the pesticide risk assessment of the active substance 2-phenylphenol. doi:10.2903/j.efsa.2009.217r.; TITLE=Peer review of the pesticide risk assessment of the active substance 2-phenylphenol; AUTHOR=EFSA; DOI=doi:10.2903/j.efsa.2009.217r; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/65201d30e4b0f0a60ddd1165; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://zenodo.org/record/5076033#.Y9fEoXbMI2z; YEAR=2009; ORIGINAL_YEAR=2009; TOXICOLOGICAL_EFFECT=histopathology: neoplastic; STUDY_GROUP=EFSA:15617597:-:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_e9a27c53863e80df78c261e5efb07fef
ToxValDB_GESTIS_DNEL 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ToxValDB_GESTIS_DNEL DNEL systemic =19.25 mg/m3 Human inhalation - Toxicity Value STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6543dd69e4b045b9ff7cd87e; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://www.dguv.de/ifa/gestis/gestis-dnel-liste/index-2.jsp; STUDY_GROUP=GESTIS DNEL:15630089:-:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_bfe5d964f4d74e614ef056286ceabcc0
ToxValDB_ToxRefDB 11 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ToxValDB_ToxRefDB LEL =377 mg/kg bw/day Rat oral subchronic; 90 days subchronic LONG_REF=Nakamura, K.; Iguchi, S.; Hiraga, K. (1982; reformatted 1990) Dow Chemical U S A Phase 3 Reformat Of Mrid 40760207. Subacute Toxicity Of O-Phenylphenol By Food Administration To Male Rats. Prepared By Tokyo Metropolitan Research Lab. 25 P.; TITLE=Dow Chemical U S A Phase 3 Reformat Of Mrid 40760207. Subacute Toxicity Of O-Phenylphenol By Food Administration To Male Rats; AUTHOR=Nakamura, K.; Iguchi, S.; Hiraga, K; EXTERNAL_SOURCE_ID=752; EXTERNAL_SOURCE_ID_DESC=ToxRefDB Study ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66bca4a3e4b0a7c65d2a792a; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://github.com/USEPA/CompTox-ToxRefDB; YEAR=1981; ORIGINAL_YEAR=1981; TOXICOLOGICAL_EFFECT=systemic: organ weight-kidney-relative to body weight|systemic: organ weight-liver-relative to body weight|systemic: in life observation-water consumption-water consumption|systemic: organ weight-brain-relative to body weight|systemic: organ weight-testes-relative to body weight|systemic: in life observation-body weight-body weight|systemic: in life observation-body weight-body weight gain|systemic: organ weight-urinary bladder-absolute|systemic: organ weight-lung-relative to body weight|systemic: organ weight-adrenal gland-relative to body weight|systemic: organ weight-spleen-relative to body weight|systemic: in life observation-food consumption-food consumption; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|food and/or water consumption|organ weight; STUDY_GROUP=ToxRefDB_dup_-_15682365_15682366_15682367:M:F0adult; QC_CATEGORY=Data source QC'd by data provider prior to ToxRefDB import; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_83639ecc1c1e75922c5a3051525a6b46
ToxValDB_ToxRefDB LEL >250 mg/kg bw/day Rabbit oral short-term (developmental); 13 days developmental LONG_REF=Zablotny, C.; Breslin, W.; Kociba, R. (1991) Ortho-Phenylphenol (OPP): Gavage Teratology Study In New Zealand White Rabbits. Lab Project Number: K-001024-045. Unpublished Study Prepared By Dow Chemical Co., Health & Env. Sciences. 309 P.; TITLE=Ortho-Phenylphenol (OPP): Gavage Teratology Study In New Zealand White Rabbits; AUTHOR=Zablotny, C.; Breslin, W.; Kociba, R; EXTERNAL_SOURCE_ID=753; EXTERNAL_SOURCE_ID_DESC=ToxRefDB Study ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66bca4a3e4b0a7c65d2a792a; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://github.com/USEPA/CompTox-ToxRefDB; YEAR=1991; ORIGINAL_YEAR=1991; STUDY_GROUP=ToxRefDB_dup_-_15682372_15682373_15682374_15682375:M/F:fetusfetal; QC_CATEGORY=Data source QC'd by data provider prior to ToxRefDB import; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_1897b45e6aa8564791fdfff9e4748f3d
ToxValDB_ToxRefDB LEL >700 mg/kg bw/day Rat oral short-term (developmental); 10 days developmental LONG_REF=John, J.; Murray, F.; Crawford, A. et al. (1978) Phase 3 Reformat Of MRIDs 00067616 and 00164362: The Effect(s) Of Orally Administered Orthophenylphenol On Rat Embryonal And Fetal Development: Project Het-K-0001024-33(R). *see study comment*; TITLE=Phase 3 Reformat Of MRIDs 00067616 and 00164362: The Effect(s) Of Orally Administered Orthophenylphenol On Rat Embryonal And Fetal Development; AUTHOR=John, J.; Murray, F.; Crawford, A. et al; EXTERNAL_SOURCE_ID=755; EXTERNAL_SOURCE_ID_DESC=ToxRefDB Study ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66bca4a3e4b0a7c65d2a792a; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://github.com/USEPA/CompTox-ToxRefDB; YEAR=1978; ORIGINAL_YEAR=1978; STUDY_GROUP=ToxRefDB_dup_-_15682380_15682381_15682382_15682383:M/F:fetusfetal; QC_CATEGORY=Data source QC'd by data provider prior to ToxRefDB import; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_e099b8589b524662f096e94fea690388
ToxValDB_ToxRefDB LEL =140 mg/kg bw/day Rat oral chronic (developmental) reproduction developmental LONG_REF=Eigenberg, D. (1990) Two-Generation Dietary Reproduction Study in Rats Using Orthophenyl Phenol: Lab Project Number: 85-671-02. Unpublished study prepared by Mobay Corp. 2696 p.; TITLE=Two-Generation Dietary Reproduction Study in Rats Using Orthophenyl Phenol: Lab Project Number: 85-671-02; AUTHOR=Eigenberg, D; EXTERNAL_SOURCE_ID=756; EXTERNAL_SOURCE_ID_DESC=ToxRefDB Study ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66bca4a3e4b0a7c65d2a792a; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://github.com/USEPA/CompTox-ToxRefDB; YEAR=1990; ORIGINAL_YEAR=1990; TOXICOLOGICAL_EFFECT=systemic: pathology microscopic-urinary bladder-cellular alteration|systemic: in life observation-body weight-body weight|systemic: pathology microscopic-urinary bladder-hyperplasia; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|nonneoplastic histopathology; STUDY_GROUP=ToxRefDB_dup_-_15682384_15682385_15682386_15682387:F:F0adult; QC_CATEGORY=Data source QC'd by data provider prior to ToxRefDB import; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_28dde25ea774fce8bf28d3a1f496a3d4
ToxValDB_ToxRefDB LEL =490 mg/kg bw/day Rat oral chronic (developmental) reproduction developmental LONG_REF=Eigenberg, D. (1990) Two-Generation Dietary Reproduction Study in Rats Using Orthophenyl Phenol: Lab Project Number: 85-671-02. Unpublished study prepared by Mobay Corp. 2696 p.; TITLE=Two-Generation Dietary Reproduction Study in Rats Using Orthophenyl Phenol: Lab Project Number: 85-671-02; AUTHOR=Eigenberg, D; EXTERNAL_SOURCE_ID=756; EXTERNAL_SOURCE_ID_DESC=ToxRefDB Study ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66bca4a3e4b0a7c65d2a792a; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://github.com/USEPA/CompTox-ToxRefDB; YEAR=1990; ORIGINAL_YEAR=1990; TOXICOLOGICAL_EFFECT=systemic: in life observation-body weight-body weight; TOXICOLOGICAL_EFFECT_CATEGORY=body weight; STUDY_GROUP=ToxRefDB_dup_-_15682392_15682393_15682394_15682395:F:F1adult; QC_CATEGORY=Data source QC'd by data provider prior to ToxRefDB import; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_2b63a819b5d955eec22dfae90a291861
ToxValDB_ToxRefDB LEL =300 mg/kg bw/day Dog oral chronic; 52 weeks chronic LONG_REF=Cosse, P.; Stebbins, K.; Stott, W.; Et Al. (1990) Ortho-Phenylphen- Ol: Palatability/Probe, Four-Week And One-Year Oral Toxicity Studies In Beagle Dogs: Lab Project Number: K-001024-038: K-001024-038A: K-001024-039. Unpublished Study Prepared By Dow Chemi; TITLE=Ortho-Phenylphen- Ol: Palatability/Probe, Four-Week And One-Year Oral Toxicity Studies In Beagle Dogs: Lab Project Number: K-001024-038: K-001024-038A: K-001024-039; AUTHOR=Cosse, P.; Stebbins, K.; Stott, W.; Et Al; EXTERNAL_SOURCE_ID=757; EXTERNAL_SOURCE_ID_DESC=ToxRefDB Study ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66bca4a3e4b0a7c65d2a792a; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://github.com/USEPA/CompTox-ToxRefDB; YEAR=1990; ORIGINAL_YEAR=1990; TOXICOLOGICAL_EFFECT=systemic: in life observation-food consumption-food consumption|systemic: in life observation-body weight-body weight gain|systemic: in life observation-food consumption-food efficiency|systemic: in life observation-clinical signs-emesis; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|clinical signs|food and/or water consumption; STUDY_GROUP=ToxRefDB_dup_-_15682416_15682417_15682418_15682419:F:F0adult; QC_CATEGORY=Data source QC'd by data provider prior to ToxRefDB import; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_f405ea706e2281fef7129695aa40f9a3
ToxValDB_ToxRefDB LOAEL =763 mg/kg bw/day Rat oral subchronic; 90 days subchronic LONG_REF=Nakamura, K.; Iguchi, S.; Hiraga, K. (1982; reformatted 1990) Dow Chemical U S A Phase 3 Reformat Of Mrid 40760207. Subacute Toxicity Of O-Phenylphenol By Food Administration To Male Rats. Prepared By Tokyo Metropolitan Research Lab. 25 P.; TITLE=Dow Chemical U S A Phase 3 Reformat Of Mrid 40760207. Subacute Toxicity Of O-Phenylphenol By Food Administration To Male Rats; AUTHOR=Nakamura, K.; Iguchi, S.; Hiraga, K; EXTERNAL_SOURCE_ID=752; EXTERNAL_SOURCE_ID_DESC=ToxRefDB Study ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66bca4a3e4b0a7c65d2a792a; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://github.com/USEPA/CompTox-ToxRefDB; YEAR=1981; ORIGINAL_YEAR=1981; TOXICOLOGICAL_EFFECT=systemic: in life observation-body weight-body weight|systemic: in life observation-body weight-body weight gain; TOXICOLOGICAL_EFFECT_CATEGORY=body weight; STUDY_GROUP=ToxRefDB_dup_-_15682365_15682366_15682367:M:F0adult; QC_CATEGORY=Data source QC'd by data provider prior to ToxRefDB import; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_f8c96ff9ad9466808cde749898cc8955
ToxValDB_ToxRefDB LOAEL =250 mg/kg bw/day Rabbit oral short-term (developmental); 13 days reproduction developmental LONG_REF=Zablotny, C.; Breslin, W.; Kociba, R. (1991) Ortho-Phenylphenol (OPP): Gavage Teratology Study In New Zealand White Rabbits. Lab Project Number: K-001024-045. Unpublished Study Prepared By Dow Chemical Co., Health & Env. Sciences. 309 P.; TITLE=Ortho-Phenylphenol (OPP): Gavage Teratology Study In New Zealand White Rabbits; AUTHOR=Zablotny, C.; Breslin, W.; Kociba, R; EXTERNAL_SOURCE_ID=753; EXTERNAL_SOURCE_ID_DESC=ToxRefDB Study ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66bca4a3e4b0a7c65d2a792a; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://github.com/USEPA/CompTox-ToxRefDB; YEAR=1991; ORIGINAL_YEAR=1991; TOXICOLOGICAL_EFFECT=systemic: in life observation-mortality-mortality|systemic: in life observation-clinical signs-perineal soiling|systemic: in life observation-clinical signs-abnormal feces; TOXICOLOGICAL_EFFECT_CATEGORY=clinical signs|mortality/survival; STUDY_GROUP=ToxRefDB_dup_-_15682368_15682369_15682370_15682371:F:F0adult; QC_CATEGORY=Data source QC'd by data provider prior to ToxRefDB import; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_e0e5d4bb29878f8e632ae2ec1587914f
ToxValDB_ToxRefDB NEL =25 mg/kg bw/day Rabbit oral short-term (developmental); 13 days reproduction developmental LONG_REF=Zablotny, C.; Breslin, W.; Kociba, R. (1991) Ortho-Phenylphenol (OPP): Gavage Teratology Study In New Zealand White Rabbits. Lab Project Number: K-001024-045. Unpublished Study Prepared By Dow Chemical Co., Health & Env. Sciences. 309 P.; TITLE=Ortho-Phenylphenol (OPP): Gavage Teratology Study In New Zealand White Rabbits; AUTHOR=Zablotny, C.; Breslin, W.; Kociba, R; EXTERNAL_SOURCE_ID=753; EXTERNAL_SOURCE_ID_DESC=ToxRefDB Study ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66bca4a3e4b0a7c65d2a792a; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://github.com/USEPA/CompTox-ToxRefDB; YEAR=1991; ORIGINAL_YEAR=1991; TOXICOLOGICAL_EFFECT=systemic: in life observation-clinical signs-urine, discoloration|systemic: pathology microscopic-kidney-degeneration|systemic: pathology microscopic-stomach-ulcer|systemic: in life observation-clinical signs-perineal soiling|systemic: in life observation-mortality-mortality|systemic: in life observation-clinical signs-abnormal feces|systemic: pathology microscopic-stomach-hemorrhage|systemic: pathology microscopic-kidney-inflammation|systemic: in life observation-clinical signs-discharge on cageboard; TOXICOLOGICAL_EFFECT_CATEGORY=clinical signs|mortality/survival|nonneoplastic histopathology; STUDY_GROUP=ToxRefDB_dup_-_15682368_15682369_15682370_15682371:F:F0adult; QC_CATEGORY=Data source QC'd by data provider prior to ToxRefDB import; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_9faf77e6c44882609e18111b5011d160
ToxValDB_ToxRefDB NEL =100 mg/kg bw/day Rat oral short-term (developmental); 10 days reproduction developmental LONG_REF=John, J.; Murray, F.; Crawford, A. et al. (1978) Phase 3 Reformat Of MRIDs 00067616 and 00164362: The Effect(s) Of Orally Administered Orthophenylphenol On Rat Embryonal And Fetal Development: Project Het-K-0001024-33(R). *see study comment*; TITLE=Phase 3 Reformat Of MRIDs 00067616 and 00164362: The Effect(s) Of Orally Administered Orthophenylphenol On Rat Embryonal And Fetal Development; AUTHOR=John, J.; Murray, F.; Crawford, A. et al; EXTERNAL_SOURCE_ID=755; EXTERNAL_SOURCE_ID_DESC=ToxRefDB Study ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66bca4a3e4b0a7c65d2a792a; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://github.com/USEPA/CompTox-ToxRefDB; YEAR=1978; ORIGINAL_YEAR=1978; TOXICOLOGICAL_EFFECT=systemic: in life observation-food consumption-food efficiency|systemic: organ weight-liver-absolute|systemic: organ weight-liver-relative to body weight|systemic: in life observation-body weight-body weight gain|systemic: in life observation-food consumption-food consumption; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|food and/or water consumption|organ weight; STUDY_GROUP=ToxRefDB_dup_-_15682376_15682377_15682378_15682379:F:F0adult; QC_CATEGORY=Data source QC'd by data provider prior to ToxRefDB import; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_0d1d3f86d9ead8a2ffe3dfda507da1c6
ToxValDB_ToxRefDB NEL =40 mg/kg bw/day Rat oral chronic (developmental) reproduction developmental LONG_REF=Eigenberg, D. (1990) Two-Generation Dietary Reproduction Study in Rats Using Orthophenyl Phenol: Lab Project Number: 85-671-02. Unpublished study prepared by Mobay Corp. 2696 p.; TITLE=Two-Generation Dietary Reproduction Study in Rats Using Orthophenyl Phenol: Lab Project Number: 85-671-02; AUTHOR=Eigenberg, D; EXTERNAL_SOURCE_ID=756; EXTERNAL_SOURCE_ID_DESC=ToxRefDB Study ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66bca4a3e4b0a7c65d2a792a; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://github.com/USEPA/CompTox-ToxRefDB; YEAR=1990; ORIGINAL_YEAR=1990; TOXICOLOGICAL_EFFECT=systemic: in life observation-body weight-body weight|systemic: pathology microscopic-urinary bladder-cellular alteration|systemic: pathology microscopic-urinary bladder-hyperplasia; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|nonneoplastic histopathology; STUDY_GROUP=ToxRefDB_dup_-_15682384_15682385_15682386_15682387:F:F0adult; QC_CATEGORY=Data source QC'd by data provider prior to ToxRefDB import; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_fb3c6feb3e37a07c61c349e62b78a207
ToxValDB_Uterotrophic_Hershberger_DB 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ToxValDB_Uterotrophic_Hershberger_DB NOEL =250 mg/kg bw/day Rat oral short-term; 10 days Hershberger LONG_REF=O-phenylphenol: Data Evaluation Records (DERs) for EDSP Tier 1 Assays Docket Number: EPA-HQ-OPP-2013-0524. Available at: http://www.regulations.gov/contentStreamer?documentId=EPA-HQ-OPP-2013-0524-0010&disposition=attachment&contentType=pdf; TITLE=O-phenylphenol: Data Evaluation Records (DERs) for EDSP Tier 1 Assays Docket Number: EPA-HQ-OPP-2013-0524; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759abc7e4b0a7c65d37b40a; RECORD_SOURCE_LEVEL=Extraction document; TOXICOLOGICAL_EFFECT=inactive|Negative|Negative|anti-androgenic|decrease in ASTs, NS (1.6 d) delay PPS; accompanied by "minor" increase in liver wt and 8% decrease in BW; NOTE AR binding and ARTA (OSRI) positive; STUDY_GROUP=Uterotrophic Hershberger DB:15714277:-:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_64e8869c42950b46a900bee46f4d1c23
ToxValDB_WHO_DWG 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ToxValDB_WHO_DWG ADI <=0.4 mg/kg Human oral - Toxicity Value STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/68c95295e4b02565fc7d2c82; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://www.who.int/teams/environment-climate-change-and-health/water-sanitation-and-health/chemical-hazards-in-drinking-water; YEAR=2003; ORIGINAL_YEAR=2003; STUDY_GROUP=WHO DWG:15954936:-:--; QC_CATEGORY=Manually extracted from unstructured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_206c98a27f71ccf9e92a4534b7add5b2
UnifiedCodex:SCCS_SHADOW:beta.noael_studies 195 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - >98 % rat oral 24 months - SOURCE_SUBDIR=sccs_o_177; REPORT_TITLE=OPINION ON o-Phenylphenol, Sodium o-phenylphenate and Potassium o-phenylphenate; OPINION_NUMBER=SCCS/1555/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=15 December 2015; VALUE_TEXT=> 98; DOSE=Decreased (p<0.01) body weights occurred in males (10 %) and females (6 %) at 20000 ppm.; EFFECT=SCCS-rejected applicant NOAEL: rol groups, only 22-32 % of the animals were alive at the end of 24 months. Decreased (p<0.01) body weights occurred in males (10 %) and females (6 %) at 20000 ppm. Another effect observed at the highest dose level was increased relative testis weight (46 %). Extensive renal damage characterised by marked tubular dilation with varying degrees of acute and chronic inflammation was found in male and female animals at the highest dose. Ref.: 106 SCCS comment Due to poor reporting the study cannot be used to derive a NOAEL. In a study from the open literature, Dowicide 1 (Lot MM01040, purity > 98 %) was administered for 91 weeks to male F344/DuCrj rats at dietary concentrations of 0, 0.625, 1.25 and 2.5 % corresponding to 0, 269, 531 and 1140 mg/kg bw/d. Survival was 100 %, 71 % (p < 0.05) and 65 % (p < 0.05) at 269, 531 and 1140 mg/kg bw/d, respectively. The following findings were observed in treated animals: increased (20 %) white blood cell count at the highest dose, hematuria at 531 and 1140 mg/kg bw/d, increased water intake; CITATION=Ref.: 106 SCCS comment Due to poor reporting the study cannot be used to derive a NOAEL; CITATION_NUMBERS=[106]; REFERENCE=Ref.: 106 SCCS comment Due to poor reporting the study cannot be used to derive a NOAEL; DETAILS_JSON={"cas_number":"90-43-7","citation":"Ref.: 106 SCCS comment Due to poor reporting the study cannot be used to derive a NOAEL","dose":"Decreased (p<0.01) body weights occurred in males (10 %) and females (6 %) at 20000 ppm.","duration":"24 months","effect":"SCCS-rejected applicant NOAEL: rol groups, only 22-32 % of the animals were alive at the end of 24 months. Decreased (p<0.01) body weights occurred in males (10 %) and females (6 %) at 20000 ppm. Another effect observed at the highest dose level was increased relative testis weight (46 %). Extensive renal damage characterised by marked tubular dilation with varying degrees of acute and chronic inflammation was found in male and female animals at the highest dose. Ref.: 106 SCCS comment Due to poor reporting the study cannot be used to derive a NOAEL. In a study from the open literature, Dowicide 1 (Lot MM01040, purity > 98 %) was administered for 91 weeks to male F344/DuCrj rats at dietary concentrations of 0, 0.625, 1.25 and 2.5 % corresponding to 0, 269, 531 and 1140 mg/kg bw/d. Survival was 100 %, 71 % (p < 0.05) and 65 % (p < 0.05) at 269, 531 and 1140 mg/kg bw/d, respectively. The following findings were observed in treated animals: increased (20 %) white blood cell count at the highest dose, hematuria at 531 and 1140 mg/kg bw/d, increased water intake","endpoint":"","ingredient":"codes.................................... 9","loael_value":"","noael_unit":"%","noael_value":"> 98","page":24,"route":"oral","species":"rat","study_id":"sccs_o_177_noael_001"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 92 mg/kg/day mouse - - - SOURCE_SUBDIR=sccs_o_177; REPORT_TITLE=OPINION ON o-Phenylphenol, Sodium o-phenylphenate and Potassium o-phenylphenate; OPINION_NUMBER=SCCS/1555/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=15 December 2015; VALUE_TEXT=92; DOSE=ion to the increased incidence, the lesion severity (e.g., tubular epithelium degeneration) also appeared to increase with dose.; EFFECT=ion to the increased incidence, the lesion severity (e.g., tubular epithelium degeneration) also appeared to increase with dose. Reduced (p<0.05) absolute kidney weights occurred in each of the OPP-treated groups (7-24 %), but the dose-response seemed consistent with the general body weight reductions noted in these groups (12-43 %). Based on the induction of renal tubular epithelium degeneration, spleen atrophy, increased water intake, and increased relative liver weight, occurring at each concentration tested, a NOAEL cannot be derived. 92 mg/kg/day can be considered as LOAEL. Ref.: 165, 166 SCCS conclusion Apparently the study was not performed according to an accepted guideline. Only male animals were used in the study. The study can be used as supporting information about OPP target tissues in mice. Tumour incidences in the liver did not represent a dose response. Types of liver cancers were not reported. Guideline: OECD TG 453 Species/strain: mouse, B6C3F1 Group size: 50/sex/dose (main group) 10/sex/dose (satellite grou; CITATION=Ref.: 165, 166 SCCS conclusion Apparently the study was not performed according to an accepted guideline; CITATION_NUMBERS=[165,166]; REFERENCE=Ref.: 165, 166 SCCS conclusion Apparently the study was not performed according to an accepted guideline; DETAILS_JSON={"cas_number":"90-43-7","citation":"Ref.: 165, 166 SCCS conclusion Apparently the study was not performed according to an accepted guideline","dose":"ion to the increased incidence, the lesion severity (e.g., tubular epithelium degeneration) also appeared to increase with dose.","duration":"","effect":"ion to the increased incidence, the lesion severity (e.g., tubular epithelium degeneration) also appeared to increase with dose. Reduced (p<0.05) absolute kidney weights occurred in each of the OPP-treated groups (7-24 %), but the dose-response seemed consistent with the general body weight reductions noted in these groups (12-43 %). Based on the induction of renal tubular epithelium degeneration, spleen atrophy, increased water intake, and increased relative liver weight, occurring at each concentration tested, a NOAEL cannot be derived. 92 mg/kg/day can be considered as LOAEL. Ref.: 165, 166 SCCS conclusion Apparently the study was not performed according to an accepted guideline. Only male animals were used in the study. The study can be used as supporting information about OPP target tissues in mice. Tumour incidences in the liver did not represent a dose response. Types of liver cancers were not reported. Guideline: OECD TG 453 Species/strain: mouse, B6C3F1 Group size: 50/sex/dose (main group) 10/sex/dose (satellite grou","endpoint":"","ingredient":"codes.................................... 9","loael_value":"","noael_unit":"mg/kg/day","noael_value":"92","page":25,"route":"","species":"mouse","study_id":"sccs_o_177_noael_002"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 250 mg/kg bw/d mouse oral 5d - SOURCE_SUBDIR=sccs_o_177; REPORT_TITLE=OPINION ON o-Phenylphenol, Sodium o-phenylphenate and Potassium o-phenylphenate; OPINION_NUMBER=SCCS/1555/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=15 December 2015; VALUE_TEXT=250; DOSE=ignificantly increased in livers of male mice, however, a statistically significant increase in hepatocellular adenoma was observed at the two highest doses (27/50 in controls, 33/50 at 250 mg/kg, 40/50 at 500 mg/kg, and 41/50 at 1000 mg/kg).; LOAEL_VALUE=250 mg/kg bw/d; EFFECT=ignificantly increased in livers of male mice, however, a statistically significant increase in hepatocellular adenoma was observed at the two highest doses (27/50 in controls, 33/50 at 250 mg/kg, 40/50 at 500 mg/kg, and 41/50 at 1000 mg/kg). In female mice, also microscopic changes in livers were seen, however, no female mouse had a hepatoblastoma and there were no statistically significant increases in liver or other tumours in the female animals. As treatment-related effects were observed in all dose groups, no NOAEL can be derived from this study. The LOAEL is considered to be 250 mg/kg bw/d. SCCS comment In this study in mice, the heart was not identified as a target organ. CalEpa considered the incidence of hepatoblastoma at the mid dose as treatment-related due to its rare spontaneous occurrence in this strain. Ref.: 220, 221 In a GLP-compliant study four groups of beagle dogs (4 animals/sex/dose) received OPP (purity 99.77 %, identification #8800005-24) at gavage doses of 0, 30, 100, or 300 mg/kg bw/d, 5d / week, for; CITATION=Ref.: 220, 221 In a GLP-compliant study four groups of beagle dogs (4 animals/sex/dose) received OPP (purity 99; CITATION_NUMBERS=[220,221,4,99]; REFERENCE=Ref.: 220, 221 In a GLP-compliant study four groups of beagle dogs (4 animals/sex/dose) received OPP (purity 99; DETAILS_JSON={"cas_number":"90-43-7","citation":"Ref.: 220, 221 In a GLP-compliant study four groups of beagle dogs (4 animals/sex/dose) received OPP (purity 99","dose":"ignificantly increased in livers of male mice, however, a statistically significant increase in hepatocellular adenoma was observed at the two highest doses (27/50 in controls, 33/50 at 250 mg/kg, 40/50 at 500 mg/kg, and 41/50 at 1000 mg/kg).","duration":"5d","effect":"ignificantly increased in livers of male mice, however, a statistically significant increase in hepatocellular adenoma was observed at the two highest doses (27/50 in controls, 33/50 at 250 mg/kg, 40/50 at 500 mg/kg, and 41/50 at 1000 mg/kg). In female mice, also microscopic changes in livers were seen, however, no female mouse had a hepatoblastoma and there were no statistically significant increases in liver or other tumours in the female animals. As treatment-related effects were observed in all dose groups, no NOAEL can be derived from this study. The LOAEL is considered to be 250 mg/kg bw/d. SCCS comment In this study in mice, the heart was not identified as a target organ. CalEpa considered the incidence of hepatoblastoma at the mid dose as treatment-related due to its rare spontaneous occurrence in this strain. Ref.: 220, 221 In a GLP-compliant study four groups of beagle dogs (4 animals/sex/dose) received OPP (purity 99.77 %, identification #8800005-24) at gavage doses of 0, 30, 100, or 300 mg/kg bw/d, 5d / week, for","endpoint":"","ingredient":"codes.................................... 9","loael_value":"250 mg/kg bw/d","noael_unit":"mg/kg bw/d","noael_value":"250","page":26,"route":"oral","species":"mouse","study_id":"sccs_o_177_noael_003"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - >300 mg/kg/day mouse oral 5d - SOURCE_SUBDIR=sccs_o_177; REPORT_TITLE=OPINION ON o-Phenylphenol, Sodium o-phenylphenate and Potassium o-phenylphenate; OPINION_NUMBER=SCCS/1555/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=15 December 2015; VALUE_TEXT=> 300; DOSE=incidence of hepatoblastoma at the mid dose as treatment-related due to its rare spontaneous occurrence in this strain.; EFFECT=incidence of hepatoblastoma at the mid dose as treatment-related due to its rare spontaneous occurrence in this strain. Ref.: 220, 221 In a GLP-compliant study four groups of beagle dogs (4 animals/sex/dose) received OPP (purity 99.77 %, identification #8800005-24) at gavage doses of 0, 30, 100, or 300 mg/kg bw/d, 5d / week, for one year. There were no effects on body weight, feed consumption, ophthalmology, haematology, urinalysis, and pathology. The only clinical sign was vomiting (dose-dependent increase). A NOAEL > 300 mg/kg/day can be derived from this study. Ref.: 32 Dermal mouse Swiss CD-1 mice (50/sex) received repeated dermal applications of 55 mg OPP (99 % purity, lot MM09157), dissolved in 0.1 ml acetone solution for 102 weeks. Treatment did not affect survival and body weight. No skin neoplasms occurred in mice dosed with OPP, however non-neoplastic lesions (ulcer, active chronic inflammation, hyperkeratosis and acanthosis) were observed at the application site. Systemically, slightly increased incidences of di; CITATION=Ref.: 220, 221 In a GLP-compliant study four groups of beagle dogs (4 animals/sex/dose) received OPP (purity 99; CITATION_NUMBERS=[220,221,4,99]; REFERENCE=Ref.: 220, 221 In a GLP-compliant study four groups of beagle dogs (4 animals/sex/dose) received OPP (purity 99; DETAILS_JSON={"cas_number":"90-43-7","citation":"Ref.: 220, 221 In a GLP-compliant study four groups of beagle dogs (4 animals/sex/dose) received OPP (purity 99","dose":"incidence of hepatoblastoma at the mid dose as treatment-related due to its rare spontaneous occurrence in this strain.","duration":"5d","effect":"incidence of hepatoblastoma at the mid dose as treatment-related due to its rare spontaneous occurrence in this strain. Ref.: 220, 221 In a GLP-compliant study four groups of beagle dogs (4 animals/sex/dose) received OPP (purity 99.77 %, identification #8800005-24) at gavage doses of 0, 30, 100, or 300 mg/kg bw/d, 5d / week, for one year. There were no effects on body weight, feed consumption, ophthalmology, haematology, urinalysis, and pathology. The only clinical sign was vomiting (dose-dependent increase). A NOAEL > 300 mg/kg/day can be derived from this study. Ref.: 32 Dermal mouse Swiss CD-1 mice (50/sex) received repeated dermal applications of 55 mg OPP (99 % purity, lot MM09157), dissolved in 0.1 ml acetone solution for 102 weeks. Treatment did not affect survival and body weight. No skin neoplasms occurred in mice dosed with OPP, however non-neoplastic lesions (ulcer, active chronic inflammation, hyperkeratosis and acanthosis) were observed at the application site. Systemically, slightly increased incidences of di","endpoint":"","ingredient":"codes.................................... 9","loael_value":"","noael_unit":"mg/kg/day","noael_value":"> 300","page":26,"route":"oral","species":"mouse","study_id":"sccs_o_177_noael_004"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 100 mg/kg bw/d rat oral - - SOURCE_SUBDIR=sccs_o_177; REPORT_TITLE=OPINION ON o-Phenylphenol, Sodium o-phenylphenate and Potassium o-phenylphenate; OPINION_NUMBER=SCCS/1555/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=15 December 2015; VALUE_TEXT=100; DOSE=hree skeletal anomalies were statistically significantly increased (~13-15 %) at 700 mg/kg/d (delayed ossification of sternebrae, pinpoint holes in the occipital or interparietal plates in the skull, and skull bone island).; EFFECT=hree skeletal anomalies were statistically significantly increased (~13-15 %) at 700 mg/kg/d (delayed ossification of sternebrae, pinpoint holes in the occipital or interparietal plates in the skull, and skull bone island). Kwock and Silva (2013) discuss, that pre-implantation losses, which were observed at the highest dose tested, might be instances of early resorptions due to the methodologies applied for evaluation of this effect. Based on the results of this study, 100 mg/kg bw/d should be regarded as maternal NOAEL (due to decreased body weight and food consumption at 300 mg/kg bw/d) and 300 mg/kg bw/d should be regarded as the foetal NOAEL. Ref.: 129; Kwock and Silva (2013) In a further study from the open literature (no information on guideline adherence or GLP), pregnant Wistar rats (18-20 dams/dose; 11 dams at the highest dose tested) were treated with OPP (99.7 % purity) by gavage at 0 (aqueous gum arabic), 150, 300, 600, or 1200 mg/kg bw/d on gestation days (GD) 6 through 15. The animals were sacrificed on GD 20. At; CITATION=Ref.: 129; CITATION_NUMBERS=[129]; REFERENCE=Ref.: 129; DETAILS_JSON={"cas_number":"90-43-7","citation":"Ref.: 129","dose":"hree skeletal anomalies were statistically significantly increased (~13-15 %) at 700 mg/kg/d (delayed ossification of sternebrae, pinpoint holes in the occipital or interparietal plates in the skull, and skull bone island).","duration":"","effect":"hree skeletal anomalies were statistically significantly increased (~13-15 %) at 700 mg/kg/d (delayed ossification of sternebrae, pinpoint holes in the occipital or interparietal plates in the skull, and skull bone island). Kwock and Silva (2013) discuss, that pre-implantation losses, which were observed at the highest dose tested, might be instances of early resorptions due to the methodologies applied for evaluation of this effect. Based on the results of this study, 100 mg/kg bw/d should be regarded as maternal NOAEL (due to decreased body weight and food consumption at 300 mg/kg bw/d) and 300 mg/kg bw/d should be regarded as the foetal NOAEL. Ref.: 129; Kwock and Silva (2013) In a further study from the open literature (no information on guideline adherence or GLP), pregnant Wistar rats (18-20 dams/dose; 11 dams at the highest dose tested) were treated with OPP (99.7 % purity) by gavage at 0 (aqueous gum arabic), 150, 300, 600, or 1200 mg/kg bw/d on gestation days (GD) 6 through 15. The animals were sacrificed on GD 20. At","endpoint":"","ingredient":"codes.................................... 9","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"100","page":36,"route":"oral","species":"rat","study_id":"sccs_o_177_noael_013"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 300 mg/kg bw/d rat oral 9 days - SOURCE_SUBDIR=sccs_o_177; REPORT_TITLE=OPINION ON o-Phenylphenol, Sodium o-phenylphenate and Potassium o-phenylphenate; OPINION_NUMBER=SCCS/1555/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=15 December 2015; VALUE_TEXT=300; DOSE=Kwock and Silva (2013) discuss, that pre-implantation losses, which were observed at the highest dose tested, might be instances of early resorptions due to the methodologies applied for evaluation of this effect.; EFFECT=, pinpoint holes in the occipital or interparietal plates in the skull, and skull bone island). Kwock and Silva (2013) discuss, that pre-implantation losses, which were observed at the highest dose tested, might be instances of early resorptions due to the methodologies applied for evaluation of this effect. Based on the results of this study, 100 mg/kg bw/d should be regarded as maternal NOAEL (due to decreased body weight and food consumption at 300 mg/kg bw/d) and 300 mg/kg bw/d should be regarded as the foetal NOAEL. Ref.: 129; Kwock and Silva (2013) In a further study from the open literature (no information on guideline adherence or GLP), pregnant Wistar rats (18-20 dams/dose; 11 dams at the highest dose tested) were treated with OPP (99.7 % purity) by gavage at 0 (aqueous gum arabic), 150, 300, 600, or 1200 mg/kg bw/d on gestation days (GD) 6 through 15. The animals were sacrificed on GD 20. At the highest dose tested, 10/11 dams died after 3-9 days of treatment. At 600 mg/kg bw/d, 2 of the 20 dams died. At ≥ 300 mg/kg b; CITATION=Ref.: 129; CITATION_NUMBERS=[129]; REFERENCE=Ref.: 129; DETAILS_JSON={"cas_number":"90-43-7","citation":"Ref.: 129","dose":"Kwock and Silva (2013) discuss, that pre-implantation losses, which were observed at the highest dose tested, might be instances of early resorptions due to the methodologies applied for evaluation of this effect.","duration":"9 days","effect":", pinpoint holes in the occipital or interparietal plates in the skull, and skull bone island). Kwock and Silva (2013) discuss, that pre-implantation losses, which were observed at the highest dose tested, might be instances of early resorptions due to the methodologies applied for evaluation of this effect. Based on the results of this study, 100 mg/kg bw/d should be regarded as maternal NOAEL (due to decreased body weight and food consumption at 300 mg/kg bw/d) and 300 mg/kg bw/d should be regarded as the foetal NOAEL. Ref.: 129; Kwock and Silva (2013) In a further study from the open literature (no information on guideline adherence or GLP), pregnant Wistar rats (18-20 dams/dose; 11 dams at the highest dose tested) were treated with OPP (99.7 % purity) by gavage at 0 (aqueous gum arabic), 150, 300, 600, or 1200 mg/kg bw/d on gestation days (GD) 6 through 15. The animals were sacrificed on GD 20. At the highest dose tested, 10/11 dams died after 3-9 days of treatment. At 600 mg/kg bw/d, 2 of the 20 dams died. At ≥ 300 mg/kg b","endpoint":"","ingredient":"codes.................................... 9","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"300","page":36,"route":"oral","species":"rat","study_id":"sccs_o_177_noael_014"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 100 % - oral - - SOURCE_SUBDIR=sccs_o_177; REPORT_TITLE=OPINION ON o-Phenylphenol, Sodium o-phenylphenate and Potassium o-phenylphenate; OPINION_NUMBER=SCCS/1555/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=15 December 2015; VALUE_TEXT=100; EFFECT=SCCS/1555/15 Revision of the Opinion on o-Phenylphenol, Sodium o-phenylphenate and Potassium o-phenylphenate ____________________________________________________________________________________________________________________ 48 No adjustment, 100 % oral absorption MOS NOAEL/SED = 3100 The use in rinse-off products is the most important use of OPP. 3.3.14 Discussion Physico-chemical properties OPP exists as solid flakes or crystalline powder at ambient conditions, SOPP exists in hydrated and non-hydrated forms and also as flakes or crystalline powders. Water solubilities of OPP and SOPP are quite high, for OPP a log Pow around 3 is given. Insufficient physico-chemical characterisation data and purity data are available for POPP. Purities of OPP and SOPP were not provided, however; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"","duration":"","effect":"SCCS/1555/15 Revision of the Opinion on o-Phenylphenol, Sodium o-phenylphenate and Potassium o-phenylphenate ____________________________________________________________________________________________________________________ 48 No adjustment, 100 % oral absorption MOS NOAEL/SED = 3100 The use in rinse-off products is the most important use of OPP. 3.3.14 Discussion Physico-chemical properties OPP exists as solid flakes or crystalline powder at ambient conditions, SOPP exists in hydrated and non-hydrated forms and also as flakes or crystalline powders. Water solubilities of OPP and SOPP are quite high, for OPP a log Pow around 3 is given. Insufficient physico-chemical characterisation data and purity data are available for POPP. Purities of OPP and SOPP were not provided, however","endpoint":"","ingredient":"codes.................................... 9","loael_value":"","noael_unit":"%","noael_value":"100","page":48,"route":"oral","species":"","study_id":"sccs_o_177_noael_027"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 4 % rat oral - - SOURCE_SUBDIR=sccs_o_177; REPORT_TITLE=OPINION ON o-Phenylphenol, Sodium o-phenylphenate and Potassium o-phenylphenate; OPINION_NUMBER=SCCS/1555/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=15 December 2015; VALUE_TEXT=4; DOSE=352, 694, 1338, and 2431 mg/kg bw/day for females papillomas plus 5 transitional cell carcinomas at 2% and 1 transitional cell carcinoma at 4%, as opposed to only 2 papillomas at 4% in females.; EFFECT=352, 694, 1338, and 2431 mg/kg bw/day for females papillomas plus 5 transitional cell carcinomas at 2% and 1 transitional cell carcinoma at 4%, as opposed to only 2 papillomas at 4% in females. No bladder calculi were observed. Moderate pyelonephritis was recorded in 6/10 males and slight in 1/10 females at 4%. No tumours at sites other than the urinary system were found. Liver: increases in liver weight; changes in liver enzymes. Kidneys: pyelonephritis in high dose males and females; increase in kidney weights. NOAEL. In 4 % males: pyelonephritis as predominating effect (60%; p≤0.01); in 2% males: neoplastic lesions in bladder as predominating effect (transitional cell papilloma, 44% (p≤0.05); transitional cell carcinoma 56% (p≤0.01). Purity SOPP > 95% Unclear (Text body in Japanese) male F344 rats (n=20/group) Dietary administration of 0, 0.625, 1.25, or 2.5% Body weight gain dose-dependently decreased at 1.25 and 2.5%. No changes were noted in biochemical investigations of plasma samples. Red blood cell count and the amoun; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"352, 694, 1338, and 2431 mg/kg bw/day for females papillomas plus 5 transitional cell carcinomas at 2% and 1 transitional cell carcinoma at 4%, as opposed to only 2 papillomas at 4% in females.","duration":"","effect":"352, 694, 1338, and 2431 mg/kg bw/day for females papillomas plus 5 transitional cell carcinomas at 2% and 1 transitional cell carcinoma at 4%, as opposed to only 2 papillomas at 4% in females. No bladder calculi were observed. Moderate pyelonephritis was recorded in 6/10 males and slight in 1/10 females at 4%. No tumours at sites other than the urinary system were found. Liver: increases in liver weight; changes in liver enzymes. Kidneys: pyelonephritis in high dose males and females; increase in kidney weights. NOAEL. In 4 % males: pyelonephritis as predominating effect (60%; p≤0.01); in 2% males: neoplastic lesions in bladder as predominating effect (transitional cell papilloma, 44% (p≤0.05); transitional cell carcinoma 56% (p≤0.01). Purity SOPP > 95% Unclear (Text body in Japanese) male F344 rats (n=20/group) Dietary administration of 0, 0.625, 1.25, or 2.5% Body weight gain dose-dependently decreased at 1.25 and 2.5%. No changes were noted in biochemical investigations of plasma samples. Red blood cell count and the amoun","endpoint":"","ingredient":"codes.................................... 9","loael_value":"","noael_unit":"%","noael_value":"4","page":80,"route":"oral","species":"rat","study_id":"sccs_o_177_noael_032"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 4 % - - 13 weeks - SOURCE_SUBDIR=sccs_o_177; REPORT_TITLE=OPINION ON o-Phenylphenol, Sodium o-phenylphenate and Potassium o-phenylphenate; OPINION_NUMBER=SCCS/1555/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=15 December 2015; VALUE_TEXT=4.0; DOSE=Unlabeled table on page 80: _____________________ 2.0 and 4.0 % SOPP for 13 weeks corresponding to 0, 85, 177, 353, 706, 1384, and 2487 mg/kg bw/day for males and 0, 87, 177, 352, 694, 1338, and 2431 mg/kg bw/day for females | ______________________________________________________________________________ papillomas plus 5 transitional cell carci...; EFFECT=Unlabeled table on page 80: _____________________ 2.0 and 4.0 % SOPP for 13 weeks corresponding to 0, 85, 177, 353, 706, 1384, and 2487 mg/kg bw/day for males and 0, 87, 177, 352, 694, 1338, and 2431 mg/kg bw/day for females | ______________________________________________________________________________ papillomas plus 5 transitional cell carcinomas at 2% and 1 transitional cell carcinoma at 4%, as opposed to only 2 papillomas at 4% in females. No bladder calculi were observed. Moderate pyelonephritis was recorded in 6/10 males and slight in 1/10 females at 4%. No tumours at sites other than the urinary system were found. Liver: increases in liver weight; changes in liver enzymes. Kidneys: pyelonephritis in high dose males and females; increase in kidney weights. | _________________ NOAEL. In 4 % males: pyelonephritis as predominating effect (60%; p≤0.01); in 2% males: neoplastic lesions in bladder as predominating effect (transitional cell papilloma, 44% (p≤0.05); transitional cell carcinoma 56% (p≤0.01). Purity SOPP > 95%; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"Unlabeled table on page 80: _____________________ 2.0 and 4.0 % SOPP for 13 weeks corresponding to 0, 85, 177, 353, 706, 1384, and 2487 mg/kg bw/day for males and 0, 87, 177, 352, 694, 1338, and 2431 mg/kg bw/day for females | ______________________________________________________________________________ papillomas plus 5 transitional cell carci...","duration":"13 weeks","effect":"Unlabeled table on page 80: _____________________ 2.0 and 4.0 % SOPP for 13 weeks corresponding to 0, 85, 177, 353, 706, 1384, and 2487 mg/kg bw/day for males and 0, 87, 177, 352, 694, 1338, and 2431 mg/kg bw/day for females | ______________________________________________________________________________ papillomas plus 5 transitional cell carcinomas at 2% and 1 transitional cell carcinoma at 4%, as opposed to only 2 papillomas at 4% in females. No bladder calculi were observed. Moderate pyelonephritis was recorded in 6/10 males and slight in 1/10 females at 4%. No tumours at sites other than the urinary system were found. Liver: increases in liver weight; changes in liver enzymes. Kidneys: pyelonephritis in high dose males and females; increase in kidney weights. | _________________ NOAEL. In 4 % males: pyelonephritis as predominating effect (60%; p≤0.01); in 2% males: neoplastic lesions in bladder as predominating effect (transitional cell papilloma, 44% (p≤0.05); transitional cell carcinoma 56% (p≤0.01). Purity SOPP > 95%","endpoint":"","ingredient":"codes.................................... 9","loael_value":"","noael_unit":"%","noael_value":"4.0","page":80,"route":"","species":"","study_id":"sccs_o_177_noael_033"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 2.5 % rat oral - - SOURCE_SUBDIR=sccs_o_177; REPORT_TITLE=OPINION ON o-Phenylphenol, Sodium o-phenylphenate and Potassium o-phenylphenate; OPINION_NUMBER=SCCS/1555/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=15 December 2015; VALUE_TEXT=2.5; DOSE=Unclear (Text body in Japanese) | male F344 rats (n=20/group) Dietary administration of 0, 0.625, 1.25, or 2.5% | Body weight gain dose-dependently decreased at 1.25 and 2.5%.; EFFECT=Unlabeled table on page 80: Unclear (Text body in Japanese) | male F344 rats (n=20/group) Dietary administration of 0, 0.625, 1.25, or 2.5% | Body weight gain dose-dependently decreased at 1.25 and 2.5%. No changes were noted in biochemical investigations of plasma samples. Red blood cell count and the amount of haemoglobin were decreased at 2.5%. The relative weight of the urinary bladder was dose-dependently increased (nearly by about 50% at the highest concentration). The | Decrease of urinary pH observed; acidification could be due to nephritis; supporting study. Publication in Japanese, only tables and numbers | 190; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"Unclear (Text body in Japanese) | male F344 rats (n=20/group) Dietary administration of 0, 0.625, 1.25, or 2.5% | Body weight gain dose-dependently decreased at 1.25 and 2.5%.","duration":"","effect":"Unlabeled table on page 80: Unclear (Text body in Japanese) | male F344 rats (n=20/group) Dietary administration of 0, 0.625, 1.25, or 2.5% | Body weight gain dose-dependently decreased at 1.25 and 2.5%. No changes were noted in biochemical investigations of plasma samples. Red blood cell count and the amount of haemoglobin were decreased at 2.5%. The relative weight of the urinary bladder was dose-dependently increased (nearly by about 50% at the highest concentration). The | Decrease of urinary pH observed; acidification could be due to nephritis; supporting study. Publication in Japanese, only tables and numbers | 190","endpoint":"","ingredient":"codes.................................... 9","loael_value":"","noael_unit":"%","noael_value":"2.5","page":80,"route":"oral","species":"rat","study_id":"sccs_o_177_noael_034"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 100 mg/kg bw/day rabbit oral 13-day - SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=100; DOSE=w/day No treatment related adverse effects on any of parameters at any dose level.; EFFECT=w/day No treatment related adverse effects on any of parameters at any dose level. NOAEL: 200 mg/kg bw/day Macintosh, 1945 in (ECHA RAC, 2022)/KL2 13-day gavage study in New Zealand rabbits (2 females/ dose); similar to OECD 407 0, 100, 500 and 1000 mg/kg bw/day At 1000 mg/kg bw/day, ↓ final body weight, ↓ in food consumption was observed. At 500 mg/kg bw/day, changes in body weight, food consumption, absolute/relative, kidney and liver weight were observed. At 100 mg/kg bw/day, ↓ absolute/relative, liver weight. NOAEL: 100 mg/kg bw/day (ECHA, 2023b; ECHA RAC, 2022)/KL2 4-week gavage study in Beagle dogs (2/sex/dose); no guideline 0, 100, 200, 300 (400 mg up to Day 5, lowered to 300 due to emesis) mg/kg bw/day 5 days/week for 4 weeks At 300 mg/kg bw/day, ↓ RBC, Hb, HCT and platelet was observed. At 200 mg/kg bw/day, dose-related emesis in all dogs, ↓ RBC and HCT count was observed. NOAEL: 100 mg/kg bw/day Cosse et al. in (EC, 2023; ECHA RAC, 2022)/KL2; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"w/day No treatment related adverse effects on any of parameters at any dose level.","duration":"13-day","effect":"w/day No treatment related adverse effects on any of parameters at any dose level. NOAEL: 200 mg/kg bw/day Macintosh, 1945 in (ECHA RAC, 2022)/KL2 13-day gavage study in New Zealand rabbits (2 females/ dose); similar to OECD 407 0, 100, 500 and 1000 mg/kg bw/day At 1000 mg/kg bw/day, ↓ final body weight, ↓ in food consumption was observed. At 500 mg/kg bw/day, changes in body weight, food consumption, absolute/relative, kidney and liver weight were observed. At 100 mg/kg bw/day, ↓ absolute/relative, liver weight. NOAEL: 100 mg/kg bw/day (ECHA, 2023b; ECHA RAC, 2022)/KL2 4-week gavage study in Beagle dogs (2/sex/dose); no guideline 0, 100, 200, 300 (400 mg up to Day 5, lowered to 300 due to emesis) mg/kg bw/day 5 days/week for 4 weeks At 300 mg/kg bw/day, ↓ RBC, Hb, HCT and platelet was observed. At 200 mg/kg bw/day, dose-related emesis in all dogs, ↓ RBC and HCT count was observed. NOAEL: 100 mg/kg bw/day Cosse et al. in (EC, 2023; ECHA RAC, 2022)/KL2","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"100","page":65,"route":"oral","species":"rabbit","study_id":"sccs_o_291_noael_025"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 100 mg/kg bw/day dog oral 4-week - SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=100; DOSE=At 100 mg/kg bw/day, ↓ absolute/relative, liver weight.; EFFECT=weight, food consumption, absolute/relative, kidney and liver weight were observed. At 100 mg/kg bw/day, ↓ absolute/relative, liver weight. NOAEL: 100 mg/kg bw/day (ECHA, 2023b; ECHA RAC, 2022)/KL2 4-week gavage study in Beagle dogs (2/sex/dose); no guideline 0, 100, 200, 300 (400 mg up to Day 5, lowered to 300 due to emesis) mg/kg bw/day 5 days/week for 4 weeks At 300 mg/kg bw/day, ↓ RBC, Hb, HCT and platelet was observed. At 200 mg/kg bw/day, dose-related emesis in all dogs, ↓ RBC and HCT count was observed. NOAEL: 100 mg/kg bw/day Cosse et al. in (EC, 2023; ECHA RAC, 2022)/KL2; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"At 100 mg/kg bw/day, ↓ absolute/relative, liver weight.","duration":"4-week","effect":"weight, food consumption, absolute/relative, kidney and liver weight were observed. At 100 mg/kg bw/day, ↓ absolute/relative, liver weight. NOAEL: 100 mg/kg bw/day (ECHA, 2023b; ECHA RAC, 2022)/KL2 4-week gavage study in Beagle dogs (2/sex/dose); no guideline 0, 100, 200, 300 (400 mg up to Day 5, lowered to 300 due to emesis) mg/kg bw/day 5 days/week for 4 weeks At 300 mg/kg bw/day, ↓ RBC, Hb, HCT and platelet was observed. At 200 mg/kg bw/day, dose-related emesis in all dogs, ↓ RBC and HCT count was observed. NOAEL: 100 mg/kg bw/day Cosse et al. in (EC, 2023; ECHA RAC, 2022)/KL2","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"100","page":65,"route":"oral","species":"dog","study_id":"sccs_o_291_noael_026"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 761 mg/kg bw/day rat oral 3 months - SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=761; DOSE=At 1669/1650 mg/kg bw/day, ↓ body weight, food, and water consumption, ↓Hb and MCH level and ↑ relative liver weight, relative kidney weight, absolute bladder weight and abnormal growth in the bladder mucosa was observed.; EFFECT=gical changes in the kidney and bladder, and ↓ Red Blood Count (RBC), Haemoglobin (Hb), Mean Corpuscular Volume (MCV), Mean Corpuscular Haemoglobin (MCH) and Mean Corpuscular Haemoglobin Concentration (MCHC) was observed. At 1669/1650 mg/kg bw/day, ↓ body weight, food, and water consumption, ↓Hb and MCH level and ↑ relative liver weight, relative kidney weight, absolute bladder weight and abnormal growth in the bladder mucosa was observed. At 761/ 803 mg/kg bw/day, changes in liver and kidney weight were observed. NOAEL: 761 mg/kg bw/day Iguchi et al., 1984 in (EC, 2023; ECHA, 2023b; ECHA RAC, 2022)/KL2 3 months dietary study (strain not specified) in rats (12/sex/group); no guideline 0, 100, 300, 1000 and 2000 mg/kg bw/day At 2000 mg/kg bw/day, slight growth retardation, ↑ liver, kidney and. in some rats (no numerical data available) At 1000 mg/kg bw/day, ↑ liver, kidney, and spleen weight in some rats (no numerical data available). NOAEL: 1000 mg/kg bw/day Hodge et al., 1952 in (ECHA RAC, 2022)/KL4 6 months gavage study (strain; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"At 1669/1650 mg/kg bw/day, ↓ body weight, food, and water consumption, ↓Hb and MCH level and ↑ relative liver weight, relative kidney weight, absolute bladder weight and abnormal growth in the bladder mucosa was observed.","duration":"3 months","effect":"gical changes in the kidney and bladder, and ↓ Red Blood Count (RBC), Haemoglobin (Hb), Mean Corpuscular Volume (MCV), Mean Corpuscular Haemoglobin (MCH) and Mean Corpuscular Haemoglobin Concentration (MCHC) was observed. At 1669/1650 mg/kg bw/day, ↓ body weight, food, and water consumption, ↓Hb and MCH level and ↑ relative liver weight, relative kidney weight, absolute bladder weight and abnormal growth in the bladder mucosa was observed. At 761/ 803 mg/kg bw/day, changes in liver and kidney weight were observed. NOAEL: 761 mg/kg bw/day Iguchi et al., 1984 in (EC, 2023; ECHA, 2023b; ECHA RAC, 2022)/KL2 3 months dietary study (strain not specified) in rats (12/sex/group); no guideline 0, 100, 300, 1000 and 2000 mg/kg bw/day At 2000 mg/kg bw/day, slight growth retardation, ↑ liver, kidney and. in some rats (no numerical data available) At 1000 mg/kg bw/day, ↑ liver, kidney, and spleen weight in some rats (no numerical data available). NOAEL: 1000 mg/kg bw/day Hodge et al., 1952 in (ECHA RAC, 2022)/KL4 6 months gavage study (strain","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"761","page":66,"route":"oral","species":"rat","study_id":"sccs_o_291_noael_028"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 1000 mg/kg bw/day rat oral 3 months - SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=1000; DOSE=At 761/ 803 mg/kg bw/day, changes in liver and kidney weight were observed.; EFFECT=a was observed. At 761/ 803 mg/kg bw/day, changes in liver and kidney weight were observed. NOAEL: 761 mg/kg bw/day Iguchi et al., 1984 in (EC, 2023; ECHA, 2023b; ECHA RAC, 2022)/KL2 3 months dietary study (strain not specified) in rats (12/sex/group); no guideline 0, 100, 300, 1000 and 2000 mg/kg bw/day At 2000 mg/kg bw/day, slight growth retardation, ↑ liver, kidney and. in some rats (no numerical data available) At 1000 mg/kg bw/day, ↑ liver, kidney, and spleen weight in some rats (no numerical data available). NOAEL: 1000 mg/kg bw/day Hodge et al., 1952 in (ECHA RAC, 2022)/KL4 6 months gavage study (strain not specified) in rats 0, 50, 100, 200 and 500 mg/kg bw/day 5 days/week At 500 mg/kg bw/day ↑ liver and kidney NOAEL: 200 mg/kg bw/day Hodge et al., 1952 in (ECHA, 2023b;; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"At 761/ 803 mg/kg bw/day, changes in liver and kidney weight were observed.","duration":"3 months","effect":"a was observed. At 761/ 803 mg/kg bw/day, changes in liver and kidney weight were observed. NOAEL: 761 mg/kg bw/day Iguchi et al., 1984 in (EC, 2023; ECHA, 2023b; ECHA RAC, 2022)/KL2 3 months dietary study (strain not specified) in rats (12/sex/group); no guideline 0, 100, 300, 1000 and 2000 mg/kg bw/day At 2000 mg/kg bw/day, slight growth retardation, ↑ liver, kidney and. in some rats (no numerical data available) At 1000 mg/kg bw/day, ↑ liver, kidney, and spleen weight in some rats (no numerical data available). NOAEL: 1000 mg/kg bw/day Hodge et al., 1952 in (ECHA RAC, 2022)/KL4 6 months gavage study (strain not specified) in rats 0, 50, 100, 200 and 500 mg/kg bw/day 5 days/week At 500 mg/kg bw/day ↑ liver and kidney NOAEL: 200 mg/kg bw/day Hodge et al., 1952 in (ECHA, 2023b;","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"1000","page":66,"route":"oral","species":"rat","study_id":"sccs_o_291_noael_029"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 200 mg/kg bw/day rat oral 6 months - SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=200; DOSE=rain not specified) in rats (12/sex/group); no guideline 0, 100, 300, 1000 and 2000 mg/kg bw/day At 2000 mg/kg bw/day, slight growth retardation, ↑ liver, kidney and. in some rats (no numerical data available) At 1000 mg/kg bw/day, ↑ liver, kidney, and spleen weight in some rats (no numerical data available).; EFFECT=rain not specified) in rats (12/sex/group); no guideline 0, 100, 300, 1000 and 2000 mg/kg bw/day At 2000 mg/kg bw/day, slight growth retardation, ↑ liver, kidney and. in some rats (no numerical data available) At 1000 mg/kg bw/day, ↑ liver, kidney, and spleen weight in some rats (no numerical data available). NOAEL: 1000 mg/kg bw/day Hodge et al., 1952 in (ECHA RAC, 2022)/KL4 6 months gavage study (strain not specified) in rats 0, 50, 100, 200 and 500 mg/kg bw/day 5 days/week At 500 mg/kg bw/day ↑ liver and kidney NOAEL: 200 mg/kg bw/day Hodge et al., 1952 in (ECHA, 2023b;; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"rain not specified) in rats (12/sex/group); no guideline 0, 100, 300, 1000 and 2000 mg/kg bw/day At 2000 mg/kg bw/day, slight growth retardation, ↑ liver, kidney and. in some rats (no numerical data available) At 1000 mg/kg bw/day, ↑ liver, kidney, and spleen weight in some rats (no numerical data available).","duration":"6 months","effect":"rain not specified) in rats (12/sex/group); no guideline 0, 100, 300, 1000 and 2000 mg/kg bw/day At 2000 mg/kg bw/day, slight growth retardation, ↑ liver, kidney and. in some rats (no numerical data available) At 1000 mg/kg bw/day, ↑ liver, kidney, and spleen weight in some rats (no numerical data available). NOAEL: 1000 mg/kg bw/day Hodge et al., 1952 in (ECHA RAC, 2022)/KL4 6 months gavage study (strain not specified) in rats 0, 50, 100, 200 and 500 mg/kg bw/day 5 days/week At 500 mg/kg bw/day ↑ liver and kidney NOAEL: 200 mg/kg bw/day Hodge et al., 1952 in (ECHA, 2023b;","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"200","page":66,"route":"oral","species":"rat","study_id":"sccs_o_291_noael_030"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 500 mg/kg bw/day dog oral Chronic - SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=500; DOSE=Similar to OECD TG 409 0, 20, 200, and 500 mg/kg bw/day At 500 mg/kg bw/day, ↑ kidney weight in males (no numerical data) was observed.; EFFECT=SCCS/1669/24 Final version Opinion on the safety of Biphenyl-2-ol and Sodium 2-biphenylolate (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 67 Study type, Species Doses Key findings NOAEL or LOAEL Reference#/ KL rating (12/sex/group); no guideline weight (no numerical data available). ECHA RAC, 2022) /KL4 Chronic studies 1-year dietary study (strain not specified) in dogs (1- 2/sex/group); Similar to OECD TG 409 0, 20, 200, and 500 mg/kg bw/day At 500 mg/kg bw/day, ↑ kidney weight in males (no numerical data) was observed. NOAEL: 200 mg/kg bw/day Hodge et al., 1952 in (EC, 2023; ECHA, 2023b; ECHA RAC, 2022)/KL2 1 year gavage study in Beagle dogs (4/sex/group); Similar to OECD TG 409 0, 30, 100, and; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"Similar to OECD TG 409 0, 20, 200, and 500 mg/kg bw/day At 500 mg/kg bw/day, ↑ kidney weight in males (no numerical data) was observed.","duration":"Chronic","effect":"SCCS/1669/24 Final version Opinion on the safety of Biphenyl-2-ol and Sodium 2-biphenylolate (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 67 Study type, Species Doses Key findings NOAEL or LOAEL Reference#/ KL rating (12/sex/group); no guideline weight (no numerical data available). ECHA RAC, 2022) /KL4 Chronic studies 1-year dietary study (strain not specified) in dogs (1- 2/sex/group); Similar to OECD TG 409 0, 20, 200, and 500 mg/kg bw/day At 500 mg/kg bw/day, ↑ kidney weight in males (no numerical data) was observed. NOAEL: 200 mg/kg bw/day Hodge et al., 1952 in (EC, 2023; ECHA, 2023b; ECHA RAC, 2022)/KL2 1 year gavage study in Beagle dogs (4/sex/group); Similar to OECD TG 409 0, 30, 100, and","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"500","page":67,"route":"oral","species":"dog","study_id":"sccs_o_291_noael_031"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 200 mg/kg bw/day dog oral Chronic - SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=200; DOSE=Similar to OECD TG 409 0, 20, 200, and 500 mg/kg bw/day At 500 mg/kg bw/day, ↑ kidney weight in males (no numerical data) was observed.; EFFECT=______________________________________ _________________________________________________________________________________________ 67 Study type, Species Doses Key findings NOAEL or LOAEL Reference#/ KL rating (12/sex/group); no guideline weight (no numerical data available). ECHA RAC, 2022) /KL4 Chronic studies 1-year dietary study (strain not specified) in dogs (1- 2/sex/group); Similar to OECD TG 409 0, 20, 200, and 500 mg/kg bw/day At 500 mg/kg bw/day, ↑ kidney weight in males (no numerical data) was observed. NOAEL: 200 mg/kg bw/day Hodge et al., 1952 in (EC, 2023; ECHA, 2023b; ECHA RAC, 2022)/KL2 1 year gavage study in Beagle dogs (4/sex/group); Similar to OECD TG 409 0, 30, 100, and 300 mg/kg bw/day At 300 mg/kg bw/day, ↓ terminal body weight in males, ↓ creatinine phosphokinase (CPK) in females and gross pathological changes such as dark regions in the pulmonary parenchyma, which is consistent with administration of test material into the lungs, resulting in anoxia/shock. NOAEL: 100 mg/kg bw/day Cosse et al. 1990 in (EC,; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"Similar to OECD TG 409 0, 20, 200, and 500 mg/kg bw/day At 500 mg/kg bw/day, ↑ kidney weight in males (no numerical data) was observed.","duration":"Chronic","effect":"______________________________________ _________________________________________________________________________________________ 67 Study type, Species Doses Key findings NOAEL or LOAEL Reference#/ KL rating (12/sex/group); no guideline weight (no numerical data available). ECHA RAC, 2022) /KL4 Chronic studies 1-year dietary study (strain not specified) in dogs (1- 2/sex/group); Similar to OECD TG 409 0, 20, 200, and 500 mg/kg bw/day At 500 mg/kg bw/day, ↑ kidney weight in males (no numerical data) was observed. NOAEL: 200 mg/kg bw/day Hodge et al., 1952 in (EC, 2023; ECHA, 2023b; ECHA RAC, 2022)/KL2 1 year gavage study in Beagle dogs (4/sex/group); Similar to OECD TG 409 0, 30, 100, and 300 mg/kg bw/day At 300 mg/kg bw/day, ↓ terminal body weight in males, ↓ creatinine phosphokinase (CPK) in females and gross pathological changes such as dark regions in the pulmonary parenchyma, which is consistent with administration of test material into the lungs, resulting in anoxia/shock. NOAEL: 100 mg/kg bw/day Cosse et al. 1990 in (EC,","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"200","page":67,"route":"oral","species":"dog","study_id":"sccs_o_291_noael_032"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 5375 mg/kg bw/day rat oral 13-week - SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=5375; DOSE=90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 68 Study type, Species Doses Key findings NOAEL or LOAEL Reference#/ KL rating (10/sex/group); no...; LOAEL_VALUE=5375 mg/kg bw/day; EFFECT=SCCS/1669/24 Final version Opinion on the safety of Biphenyl-2-ol and Sodium 2-biphenylolate (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 68 Study type, Species Doses Key findings NOAEL or LOAEL Reference#/ KL rating (10/sex/group); no guideline weighted average doses of 0, 451, 902, 1581, 3529 and 5375 mg/kg bw/day in males and 0, 488, 976, 1926, 4294 and 6349 mg/kg bw/day in females, respectively) intake, ↑ urinary pH value and ↓ urine density. and females, respectively 13-week dietary study in F344 rats (10/sex/group); no guideline 0, 0.125, 0.25, 0.5, 1, 2 and 4% (corresponding to 0, 85, 177, 353, 706, 1384 and 2487 in males and 0, 87, 177, 352, 694, 1338 and 2431 mg/kg bw/day in females, res; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 68 Study type, Species Doses Key findings NOAEL or LOAEL Reference#/ KL rating (10/sex/group); no...","duration":"13-week","effect":"SCCS/1669/24 Final version Opinion on the safety of Biphenyl-2-ol and Sodium 2-biphenylolate (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 68 Study type, Species Doses Key findings NOAEL or LOAEL Reference#/ KL rating (10/sex/group); no guideline weighted average doses of 0, 451, 902, 1581, 3529 and 5375 mg/kg bw/day in males and 0, 488, 976, 1926, 4294 and 6349 mg/kg bw/day in females, respectively) intake, ↑ urinary pH value and ↓ urine density. and females, respectively 13-week dietary study in F344 rats (10/sex/group); no guideline 0, 0.125, 0.25, 0.5, 1, 2 and 4% (corresponding to 0, 85, 177, 353, 706, 1384 and 2487 in males and 0, 87, 177, 352, 694, 1338 and 2431 mg/kg bw/day in females, res","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"5375 mg/kg bw/day","noael_unit":"mg/kg bw/day","noael_value":"5375","page":68,"route":"oral","species":"rat","study_id":"sccs_o_291_noael_036"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 353 mg/kg bw/day rat oral 13-week - SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=353; DOSE=les, respectively) intake, ↑ urinary pH value and ↓ urine density. and females, respectively 13-week dietary study in F344 rats (10/sex/group); no guideline 0, 0.125, 0.25, 0.5, 1, 2 and 4% (corresponding to 0, 85, 177, 353, 706, 1384 and 2487 in males and 0, 87, 177, 352, 694, 1338 and 2431 mg/kg bw/day in females, respectively) At 2431/2487 mg...; EFFECT=les, respectively) intake, ↑ urinary pH value and ↓ urine density. and females, respectively 13-week dietary study in F344 rats (10/sex/group); no guideline 0, 0.125, 0.25, 0.5, 1, 2 and 4% (corresponding to 0, 85, 177, 353, 706, 1384 and 2487 in males and 0, 87, 177, 352, 694, 1338 and 2431 mg/kg bw/day in females, respectively) At 2431/2487 mg/kg bw/day, ↓ body weight, moderate pyelonephritis was observed. At 1338/1384 mg/kg bw/day, ↓ body weight was observed. At 694/706 mg/kg bw/day, ↓ body weight was observed. NOAEL: 353 mg/kg bw/day Iguchi et al., 1979 in (SCCS, 2015)/KL2 13-week dietary study in F344 rats (20/sex/group); no guideline 0, 0.625, 1.25, and 2.5% (correspond- ding to weighted average doses of 0, 625 1250 and 2500 in males and 0, 706, 1411 and 2823 mg/kg bw/day in females, respectively) At 2500/2823 mg/kg bw/day, ↓ body weight gain was observed. At 1250/1411 mg/kg bw/day, ↓ body weight gain was observed. NOAEL: 625 mg/kg bw/day Nakamura et al., 1981 in (SCCS, 2015)/KL2 90-day dietary study in male F344 rats (grou; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"les, respectively) intake, ↑ urinary pH value and ↓ urine density. and females, respectively 13-week dietary study in F344 rats (10/sex/group); no guideline 0, 0.125, 0.25, 0.5, 1, 2 and 4% (corresponding to 0, 85, 177, 353, 706, 1384 and 2487 in males and 0, 87, 177, 352, 694, 1338 and 2431 mg/kg bw/day in females, respectively) At 2431/2487 mg...","duration":"13-week","effect":"les, respectively) intake, ↑ urinary pH value and ↓ urine density. and females, respectively 13-week dietary study in F344 rats (10/sex/group); no guideline 0, 0.125, 0.25, 0.5, 1, 2 and 4% (corresponding to 0, 85, 177, 353, 706, 1384 and 2487 in males and 0, 87, 177, 352, 694, 1338 and 2431 mg/kg bw/day in females, respectively) At 2431/2487 mg/kg bw/day, ↓ body weight, moderate pyelonephritis was observed. At 1338/1384 mg/kg bw/day, ↓ body weight was observed. At 694/706 mg/kg bw/day, ↓ body weight was observed. NOAEL: 353 mg/kg bw/day Iguchi et al., 1979 in (SCCS, 2015)/KL2 13-week dietary study in F344 rats (20/sex/group); no guideline 0, 0.625, 1.25, and 2.5% (correspond- ding to weighted average doses of 0, 625 1250 and 2500 in males and 0, 706, 1411 and 2823 mg/kg bw/day in females, respectively) At 2500/2823 mg/kg bw/day, ↓ body weight gain was observed. At 1250/1411 mg/kg bw/day, ↓ body weight gain was observed. NOAEL: 625 mg/kg bw/day Nakamura et al., 1981 in (SCCS, 2015)/KL2 90-day dietary study in male F344 rats (grou","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"353","page":68,"route":"oral","species":"rat","study_id":"sccs_o_291_noael_037"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 625 mg/kg bw/day rat oral 13-week - SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=625; DOSE=1338/1384 mg/kg bw/day, ↓ body weight was observed.; LOAEL_VALUE=2000 mg/kg bw/day; EFFECT=1338/1384 mg/kg bw/day, ↓ body weight was observed. At 694/706 mg/kg bw/day, ↓ body weight was observed. NOAEL: 353 mg/kg bw/day Iguchi et al., 1979 in (SCCS, 2015)/KL2 13-week dietary study in F344 rats (20/sex/group); no guideline 0, 0.625, 1.25, and 2.5% (correspond- ding to weighted average doses of 0, 625 1250 and 2500 in males and 0, 706, 1411 and 2823 mg/kg bw/day in females, respectively) At 2500/2823 mg/kg bw/day, ↓ body weight gain was observed. At 1250/1411 mg/kg bw/day, ↓ body weight gain was observed. NOAEL: 625 mg/kg bw/day Nakamura et al., 1981 in (SCCS, 2015)/KL2 90-day dietary study in male F344 rats (group not specified); no guideline 0 and 2% (correspond- ding to weighted average doses of 2000 mg/kg bw/day) At 2000 mg/kg bw/day, ↑ thickness of the bladder epithelium from Day 14 until end of study (classified as hyperplasia with accompanying increased frequency of cell infiltration) was observed. LOAEL: 2000 mg/kg bw/day Reitz et al., 1983 in (SCCS, 2015)/KL2; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"1338/1384 mg/kg bw/day, ↓ body weight was observed.","duration":"13-week","effect":"1338/1384 mg/kg bw/day, ↓ body weight was observed. At 694/706 mg/kg bw/day, ↓ body weight was observed. NOAEL: 353 mg/kg bw/day Iguchi et al., 1979 in (SCCS, 2015)/KL2 13-week dietary study in F344 rats (20/sex/group); no guideline 0, 0.625, 1.25, and 2.5% (correspond- ding to weighted average doses of 0, 625 1250 and 2500 in males and 0, 706, 1411 and 2823 mg/kg bw/day in females, respectively) At 2500/2823 mg/kg bw/day, ↓ body weight gain was observed. At 1250/1411 mg/kg bw/day, ↓ body weight gain was observed. NOAEL: 625 mg/kg bw/day Nakamura et al., 1981 in (SCCS, 2015)/KL2 90-day dietary study in male F344 rats (group not specified); no guideline 0 and 2% (correspond- ding to weighted average doses of 2000 mg/kg bw/day) At 2000 mg/kg bw/day, ↑ thickness of the bladder epithelium from Day 14 until end of study (classified as hyperplasia with accompanying increased frequency of cell infiltration) was observed. LOAEL: 2000 mg/kg bw/day Reitz et al., 1983 in (SCCS, 2015)/KL2","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"2000 mg/kg bw/day","noael_unit":"mg/kg bw/day","noael_value":"625","page":68,"route":"oral","species":"rat","study_id":"sccs_o_291_noael_038"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 248 mg/kg bw/day - - - - SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=248; DOSE=At 200/248 mg/kg bw/day, neoplastic changes in the urinary bladder, such as ↑ incidence of transitional cell carcinomas in males, ↓ body weight, body weight gain, food consumption and food efficiency, ↑clinical signs and gross pathological signs of toxicity. and females, respectively SCCS, 2015;; EFFECT=SCCS/1669/24 Final version Opinion on the safety of Biphenyl-2-ol and Sodium 2-biphenylolate (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 94 Study type, Species Doses Key findings NOAEL/ LOAEL Reference / KL rating (50/sex/group); OECD TG 453 males/females, respectively cell carcinomas, ↑ incidence of papillomas in males was observed. Non-neoplastic changes in the urinary bladder and kidney were observed. At 200/248 mg/kg bw/day, neoplastic changes in the urinary bladder, such as ↑ incidence of transitional cell carcinomas in males, ↓ body weight, body weight gain, food consumption and food efficiency, ↑clinical signs and gross pathological signs of toxicity. and females, respectively SCCS, 2015;; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"At 200/248 mg/kg bw/day, neoplastic changes in the urinary bladder, such as ↑ incidence of transitional cell carcinomas in males, ↓ body weight, body weight gain, food consumption and food efficiency, ↑clinical signs and gross pathological signs of toxicity. and females, respectively SCCS, 2015;","duration":"","effect":"SCCS/1669/24 Final version Opinion on the safety of Biphenyl-2-ol and Sodium 2-biphenylolate (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 94 Study type, Species Doses Key findings NOAEL/ LOAEL Reference / KL rating (50/sex/group); OECD TG 453 males/females, respectively cell carcinomas, ↑ incidence of papillomas in males was observed. Non-neoplastic changes in the urinary bladder and kidney were observed. At 200/248 mg/kg bw/day, neoplastic changes in the urinary bladder, such as ↑ incidence of transitional cell carcinomas in males, ↓ body weight, body weight gain, food consumption and food efficiency, ↑clinical signs and gross pathological signs of toxicity. and females, respectively SCCS, 2015;","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"248","page":94,"route":"","species":"","study_id":"sccs_o_291_noael_069"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 3081 mg/kg bw/day - oral 96-week - SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=3081; DOSE=Systemically, slightly increased incidences of dilatation of the kidney tubules compared to acetone controls were observed in OPP treated animals.; EFFECT=effect. Systemically, slightly increased incidences of dilatation of the kidney tubules compared to acetone controls were observed in OPP treated animals. In males, a greater incidence of focal necrosis of the liver (of mild degree) was observed. OPP, alone or after tumour initiation with DMBA, did not increase the incidence of neoplastic skin lesions when applied dermally over two years National Toxicology Program, 1986 in (SCCS, 2015)/KL2 SOPP Oral 96-week dietary 0, 0.5, 1.0 and 2.0% At 3009/3081 mg/kg bw/day, NOAEL Hagiwara et; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"Systemically, slightly increased incidences of dilatation of the kidney tubules compared to acetone controls were observed in OPP treated animals.","duration":"96-week","effect":"effect. Systemically, slightly increased incidences of dilatation of the kidney tubules compared to acetone controls were observed in OPP treated animals. In males, a greater incidence of focal necrosis of the liver (of mild degree) was observed. OPP, alone or after tumour initiation with DMBA, did not increase the incidence of neoplastic skin lesions when applied dermally over two years National Toxicology Program, 1986 in (SCCS, 2015)/KL2 SOPP Oral 96-week dietary 0, 0.5, 1.0 and 2.0% At 3009/3081 mg/kg bw/day, NOAEL Hagiwara et","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"3081","page":94,"route":"oral","species":"","study_id":"sccs_o_291_noael_071"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 3009 mg/kg bw/day mouse - - - SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=3009; DOSE=90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 95 Study type, Species Doses Key findings NOAEL/ LOAEL Reference / KL rating study in B6C3F1 mice...; LOAEL_VALUE=3009 mg/kg bw/day; EFFECT=SCCS/1669/24 Final version Opinion on the safety of Biphenyl-2-ol and Sodium 2-biphenylolate (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 95 Study type, Species Doses Key findings NOAEL/ LOAEL Reference / KL rating study in B6C3F1 mice (50/sex/group); no guideline equivalent to 0, 591, 1451, and 3009 mg/kg bw/day for the males and 0, 480, 1464, and 3081 mg/kg bw/day for the females, respectively ↑hepatocellular carcinomas and calcification of the brain were observed. At 1451/1464 mg/kg bw/day ↑ haemangiosarcomas of the liver, ↑hepatocellular carcinomas were observed. At 480 mg/kg bw/day, cystic endometrial hyperplasia of the uterus in females was observed in females. Authors considered increased; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 95 Study type, Species Doses Key findings NOAEL/ LOAEL Reference / KL rating study in B6C3F1 mice...","duration":"","effect":"SCCS/1669/24 Final version Opinion on the safety of Biphenyl-2-ol and Sodium 2-biphenylolate (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 95 Study type, Species Doses Key findings NOAEL/ LOAEL Reference / KL rating study in B6C3F1 mice (50/sex/group); no guideline equivalent to 0, 591, 1451, and 3009 mg/kg bw/day for the males and 0, 480, 1464, and 3081 mg/kg bw/day for the females, respectively ↑hepatocellular carcinomas and calcification of the brain were observed. At 1451/1464 mg/kg bw/day ↑ haemangiosarcomas of the liver, ↑hepatocellular carcinomas were observed. At 480 mg/kg bw/day, cystic endometrial hyperplasia of the uterus in females was observed in females. Authors considered increased","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"3009 mg/kg bw/day","noael_unit":"mg/kg bw/day","noael_value":"3009","page":95,"route":"","species":"mouse","study_id":"sccs_o_291_noael_072"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 770 mg/kg bw/day rat - - - SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=770; DOSE=90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 96 Study type, Species Doses Key findings NOAEL/ LOAEL Reference / KL rating study in F344 rats (...; LOAEL_VALUE=770 mg/kg bw/day; EFFECT=SCCS/1669/24 Final version Opinion on the safety of Biphenyl-2-ol and Sodium 2-biphenylolate (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 96 Study type, Species Doses Key findings NOAEL/ LOAEL Reference / KL rating study in F344 rats (50/sex/group); no guideline equivalent to 0, 270 and 770 mg/kg bw/day, respectively) and Females: 0, 5000 and 10000 ppm equivalent to 0, 224 and 466 mg/kg bw/day, respectively pancreas and ↑ incidences of interstitial nephritis of the kidney were observed. At 466/770 mg/kg bw/day in the kidneys, both non- neoplastic changes (interstitial nephritis and pyelonephritis) and neoplastic changes (transitional cell papilloma and carcinoma) occurred in low incidences in the; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 96 Study type, Species Doses Key findings NOAEL/ LOAEL Reference / KL rating study in F344 rats (...","duration":"","effect":"SCCS/1669/24 Final version Opinion on the safety of Biphenyl-2-ol and Sodium 2-biphenylolate (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 96 Study type, Species Doses Key findings NOAEL/ LOAEL Reference / KL rating study in F344 rats (50/sex/group); no guideline equivalent to 0, 270 and 770 mg/kg bw/day, respectively) and Females: 0, 5000 and 10000 ppm equivalent to 0, 224 and 466 mg/kg bw/day, respectively pancreas and ↑ incidences of interstitial nephritis of the kidney were observed. At 466/770 mg/kg bw/day in the kidneys, both non- neoplastic changes (interstitial nephritis and pyelonephritis) and neoplastic changes (transitional cell papilloma and carcinoma) occurred in low incidences in the","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"770 mg/kg bw/day","noael_unit":"mg/kg bw/day","noael_value":"770","page":96,"route":"","species":"rat","study_id":"sccs_o_291_noael_074"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 2000 mg/kg bw/day rat dermal 52-week - SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=2000; DOSE=90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 97 Study type, Species Doses Key findings NOAEL/ LOAEL Reference / KL rating study in male F344 r...; LOAEL_VALUE=2000 mg/kg bw/day; EFFECT=SCCS/1669/24 Final version Opinion on the safety of Biphenyl-2-ol and Sodium 2-biphenylolate (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 97 Study type, Species Doses Key findings NOAEL/ LOAEL Reference / KL rating study in male F344 rats (50 /group) equivalent to approximately 250, 500, 1000, 1500 and 2000 mg/kg bw/day was observed in rats. At 1500 mg/kg bw/day and above, urinary bladder tumour formation was observed. and systemic toxicity): 1000 mg/kg bw/day 2015{Cal EPA, 2007 #4752)} /KL2 Dermal 52-week, two- stage mouse skin carcinogenesis study in female CD-1 mice Initiation: SOPP in DMSO (10 mg/100 µL) or DMBA ( (10 µg/100 µl) twice weekly for 5 weeks. Promotion: starting 1 week after last; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 97 Study type, Species Doses Key findings NOAEL/ LOAEL Reference / KL rating study in male F344 r...","duration":"52-week","effect":"SCCS/1669/24 Final version Opinion on the safety of Biphenyl-2-ol and Sodium 2-biphenylolate (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 97 Study type, Species Doses Key findings NOAEL/ LOAEL Reference / KL rating study in male F344 rats (50 /group) equivalent to approximately 250, 500, 1000, 1500 and 2000 mg/kg bw/day was observed in rats. At 1500 mg/kg bw/day and above, urinary bladder tumour formation was observed. and systemic toxicity): 1000 mg/kg bw/day 2015{Cal EPA, 2007 #4752)} /KL2 Dermal 52-week, two- stage mouse skin carcinogenesis study in female CD-1 mice Initiation: SOPP in DMSO (10 mg/100 µL) or DMBA ( (10 µg/100 µl) twice weekly for 5 weeks. Promotion: starting 1 week after last","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"2000 mg/kg bw/day","noael_unit":"mg/kg bw/day","noael_value":"2000","page":97,"route":"dermal","species":"rat","study_id":"sccs_o_291_noael_078"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 65 - - - - - SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=unclear:Unlabeled table on page 65: Study type, | Doses | Key findings | NOAEL or | Reference#/ KL rating; EFFECT=Unlabeled table on page 65: Study type, | Doses | Key findings | NOAEL or | Reference#/ KL rating; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"","duration":"","effect":"Unlabeled table on page 65: Study type, | Doses | Key findings | NOAEL or | Reference#/ KL rating","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"","noael_value":"unclear:Unlabeled table on page 65: Study type, | Doses | Key findings | NOAEL or | Reference#/ KL rating","page":65,"route":"","species":"","study_id":"sccs_o_291_noael_082"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 200 mg/kg bw/day rat oral 32-day - SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=200; DOSE=32-day gavage study in male rats (15 males/ group); no guideline | 0, 2, 20 and 200 mg/kg bw/day | No treatment related adverse effects on any of parameters at any dose level. | NOAEL:; EFFECT=Unlabeled table on page 65: 32-day gavage study in male rats (15 males/ group); no guideline | 0, 2, 20 and 200 mg/kg bw/day | No treatment related adverse effects on any of parameters at any dose level. | NOAEL: 200 mg/kg bw/day | Macintosh, 1945 in (ECHA RAC, 2022)/KL2; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"32-day gavage study in male rats (15 males/ group); no guideline | 0, 2, 20 and 200 mg/kg bw/day | No treatment related adverse effects on any of parameters at any dose level. | NOAEL:","duration":"32-day","effect":"Unlabeled table on page 65: 32-day gavage study in male rats (15 males/ group); no guideline | 0, 2, 20 and 200 mg/kg bw/day | No treatment related adverse effects on any of parameters at any dose level. | NOAEL: 200 mg/kg bw/day | Macintosh, 1945 in (ECHA RAC, 2022)/KL2","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"200","page":65,"route":"oral","species":"rat","study_id":"sccs_o_291_noael_083"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 1000 mg/kg bw/day rabbit oral 13-day - SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=1000; DOSE=13-day gavage study in New Zealand rabbits (2 females/ dose); similar to OECD 407 | 0, 100, 500 and 1000 mg/kg bw/day | At 1000 mg/kg bw/day, ↓ final body weight, ↓ in food consumption was observed.; EFFECT=Unlabeled table on page 65: 13-day gavage study in New Zealand rabbits (2 females/ dose); similar to OECD 407 | 0, 100, 500 and 1000 mg/kg bw/day | At 1000 mg/kg bw/day, ↓ final body weight, ↓ in food consumption was observed. At 500 mg/kg bw/day, changes in body weight, food consumption, absolute/relative, kidney and liver weight were observed. At 100 mg/kg bw/day, ↓ absolute/relative, liver weight. | NOAEL: 100 mg/kg bw/day | (ECHA, 2023b; ECHA RAC, 2022)/KL2; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"13-day gavage study in New Zealand rabbits (2 females/ dose); similar to OECD 407 | 0, 100, 500 and 1000 mg/kg bw/day | At 1000 mg/kg bw/day, ↓ final body weight, ↓ in food consumption was observed.","duration":"13-day","effect":"Unlabeled table on page 65: 13-day gavage study in New Zealand rabbits (2 females/ dose); similar to OECD 407 | 0, 100, 500 and 1000 mg/kg bw/day | At 1000 mg/kg bw/day, ↓ final body weight, ↓ in food consumption was observed. At 500 mg/kg bw/day, changes in body weight, food consumption, absolute/relative, kidney and liver weight were observed. At 100 mg/kg bw/day, ↓ absolute/relative, liver weight. | NOAEL: 100 mg/kg bw/day | (ECHA, 2023b; ECHA RAC, 2022)/KL2","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"1000","page":65,"route":"oral","species":"rabbit","study_id":"sccs_o_291_noael_084"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 300 mg/kg bw/day dog oral 4-week - SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=300; DOSE=4-week gavage study in Beagle dogs (2/sex/dose); no guideline | 0, 100, 200, 300 (400 mg up to Day 5, lowered to 300 due to emesis) mg/kg bw/day 5 days/week for 4 weeks | At 300 mg/kg bw/day, ↓ RBC, Hb, HCT and platelet was observed.; EFFECT=Unlabeled table on page 65: 4-week gavage study in Beagle dogs (2/sex/dose); no guideline | 0, 100, 200, 300 (400 mg up to Day 5, lowered to 300 due to emesis) mg/kg bw/day 5 days/week for 4 weeks | At 300 mg/kg bw/day, ↓ RBC, Hb, HCT and platelet was observed. At 200 mg/kg bw/day, dose-related emesis in all dogs, ↓ RBC and HCT count was observed. | NOAEL: 100 mg/kg bw/day | Cosse et al. in (EC, 2023; ECHA RAC, 2022)/KL2; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"4-week gavage study in Beagle dogs (2/sex/dose); no guideline | 0, 100, 200, 300 (400 mg up to Day 5, lowered to 300 due to emesis) mg/kg bw/day 5 days/week for 4 weeks | At 300 mg/kg bw/day, ↓ RBC, Hb, HCT and platelet was observed.","duration":"4-week","effect":"Unlabeled table on page 65: 4-week gavage study in Beagle dogs (2/sex/dose); no guideline | 0, 100, 200, 300 (400 mg up to Day 5, lowered to 300 due to emesis) mg/kg bw/day 5 days/week for 4 weeks | At 300 mg/kg bw/day, ↓ RBC, Hb, HCT and platelet was observed. At 200 mg/kg bw/day, dose-related emesis in all dogs, ↓ RBC and HCT count was observed. | NOAEL: 100 mg/kg bw/day | Cosse et al. in (EC, 2023; ECHA RAC, 2022)/KL2","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"300","page":65,"route":"oral","species":"dog","study_id":"sccs_o_291_noael_085"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 2000 mg/kg bw/day rat oral 1-month - SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=2000; DOSE=1-month dietary study in rats (strain not specified) (5 females/ group); no guideline | 0, 2000, 3000, 4000, 5000 and 10000 mg/kg bw/day | At 2000 mg/kg bw/day and slight growth retardation was observed, all of the other dose groups lost weight rapidly. | LOAEL:; LOAEL_VALUE=2000 mg/kg bw/day; EFFECT=Unlabeled table on page 65: 1-month dietary study in rats (strain not specified) (5 females/ group); no guideline | 0, 2000, 3000, 4000, 5000 and 10000 mg/kg bw/day | At 2000 mg/kg bw/day and slight growth retardation was observed, all of the other dose groups lost weight rapidly. | LOAEL: 2000 mg/kg bw/day | Hodge et al., 1952 in (ECHA RAC, 2022)/KL2; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"1-month dietary study in rats (strain not specified) (5 females/ group); no guideline | 0, 2000, 3000, 4000, 5000 and 10000 mg/kg bw/day | At 2000 mg/kg bw/day and slight growth retardation was observed, all of the other dose groups lost weight rapidly. | LOAEL:","duration":"1-month","effect":"Unlabeled table on page 65: 1-month dietary study in rats (strain not specified) (5 females/ group); no guideline | 0, 2000, 3000, 4000, 5000 and 10000 mg/kg bw/day | At 2000 mg/kg bw/day and slight growth retardation was observed, all of the other dose groups lost weight rapidly. | LOAEL: 2000 mg/kg bw/day | Hodge et al., 1952 in (ECHA RAC, 2022)/KL2","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"2000 mg/kg bw/day","noael_unit":"mg/kg bw/day","noael_value":"2000","page":65,"route":"oral","species":"rat","study_id":"sccs_o_291_noael_086"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 100 mg/kg bw/day rabbit oral 13-day - SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=100; DOSE=13-day gavage study in New Zealand rabbits (2 females/ dose); similar to OECD 407 | 0, 100, 500 and 1000 mg/kg bw/day | At 1000 mg/kg bw/day, ↓ final body weight, ↓ in food consumption was observed.; EFFECT=Unlabeled table on page 65: 13-day gavage study in New Zealand rabbits (2 females/ dose); similar to OECD 407 | 0, 100, 500 and 1000 mg/kg bw/day | At 1000 mg/kg bw/day, ↓ final body weight, ↓ in food consumption was observed. At 500 mg/kg bw/day, changes in body weight, food consumption, absolute/relative, kidney and liver weight were observed. At 100 mg/kg bw/day, ↓ absolute/relative, liver weight. | NOAEL: 100 mg/kg bw/day | (ECHA, 2023b; ECHA RAC, 2022)/KL2; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"13-day gavage study in New Zealand rabbits (2 females/ dose); similar to OECD 407 | 0, 100, 500 and 1000 mg/kg bw/day | At 1000 mg/kg bw/day, ↓ final body weight, ↓ in food consumption was observed.","duration":"13-day","effect":"Unlabeled table on page 65: 13-day gavage study in New Zealand rabbits (2 females/ dose); similar to OECD 407 | 0, 100, 500 and 1000 mg/kg bw/day | At 1000 mg/kg bw/day, ↓ final body weight, ↓ in food consumption was observed. At 500 mg/kg bw/day, changes in body weight, food consumption, absolute/relative, kidney and liver weight were observed. At 100 mg/kg bw/day, ↓ absolute/relative, liver weight. | NOAEL: 100 mg/kg bw/day | (ECHA, 2023b; ECHA RAC, 2022)/KL2","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"100","page":65,"route":"oral","species":"rabbit","study_id":"sccs_o_291_noael_087"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 100 mg/kg bw/day dog oral 4-week - SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=100; DOSE=4-week gavage study in Beagle dogs (2/sex/dose); no guideline | 0, 100, 200, 300 (400 mg up to Day 5, lowered to 300 due to emesis) mg/kg bw/day 5 days/week for 4 weeks | At 300 mg/kg bw/day, ↓ RBC, Hb, HCT and platelet was observed.; EFFECT=Unlabeled table on page 65: 4-week gavage study in Beagle dogs (2/sex/dose); no guideline | 0, 100, 200, 300 (400 mg up to Day 5, lowered to 300 due to emesis) mg/kg bw/day 5 days/week for 4 weeks | At 300 mg/kg bw/day, ↓ RBC, Hb, HCT and platelet was observed. At 200 mg/kg bw/day, dose-related emesis in all dogs, ↓ RBC and HCT count was observed. | NOAEL: 100 mg/kg bw/day | Cosse et al. in (EC, 2023; ECHA RAC, 2022)/KL2; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"4-week gavage study in Beagle dogs (2/sex/dose); no guideline | 0, 100, 200, 300 (400 mg up to Day 5, lowered to 300 due to emesis) mg/kg bw/day 5 days/week for 4 weeks | At 300 mg/kg bw/day, ↓ RBC, Hb, HCT and platelet was observed.","duration":"4-week","effect":"Unlabeled table on page 65: 4-week gavage study in Beagle dogs (2/sex/dose); no guideline | 0, 100, 200, 300 (400 mg up to Day 5, lowered to 300 due to emesis) mg/kg bw/day 5 days/week for 4 weeks | At 300 mg/kg bw/day, ↓ RBC, Hb, HCT and platelet was observed. At 200 mg/kg bw/day, dose-related emesis in all dogs, ↓ RBC and HCT count was observed. | NOAEL: 100 mg/kg bw/day | Cosse et al. in (EC, 2023; ECHA RAC, 2022)/KL2","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"100","page":65,"route":"oral","species":"dog","study_id":"sccs_o_291_noael_088"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 66 - - - - - SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=unclear:Unlabeled table on page 66: Study type, Species | Doses | Key findings | NOAEL or LOAEL | Reference#/ KL rating; EFFECT=Unlabeled table on page 66: Study type, Species | Doses | Key findings | NOAEL or LOAEL | Reference#/ KL rating; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"","duration":"","effect":"Unlabeled table on page 66: Study type, Species | Doses | Key findings | NOAEL or LOAEL | Reference#/ KL rating","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"","noael_value":"unclear:Unlabeled table on page 66: Study type, Species | Doses | Key findings | NOAEL or LOAEL | Reference#/ KL rating","page":66,"route":"","species":"","study_id":"sccs_o_291_noael_089"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 2.5 % rat oral 13-week - SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=2.5; DOSE=13-week dietary study in F344/DuCrj Rats (10/sex/group); similar to OECD TG 408 | 0, 0.156, 0.313, 0.625, 1.25, and 2.5% OPP equivalent to 0, 182, 391, 761, 1669, and 2798 mg/kg bw/day in males and 0, 202, 411, 803, 1650, and 3014 mg/kg bw/day in females | At 2798/3014 mg/kg bw/day, ↓ body weight, terminal body weight, food and water consumption...; EFFECT=Unlabeled table on page 66: 13-week dietary study in F344/DuCrj Rats (10/sex/group); similar to OECD TG 408 | 0, 0.156, 0.313, 0.625, 1.25, and 2.5% OPP equivalent to 0, 182, 391, 761, 1669, and 2798 mg/kg bw/day in males and 0, 202, 411, 803, 1650, and 3014 mg/kg bw/day in females | At 2798/3014 mg/kg bw/day, ↓ body weight, terminal body weight, food and water consumption, changes in organ weight, and histopathological changes in the kidney and bladder, and ↓ Red Blood Count (RBC), Haemoglobin (Hb), Mean Corpuscular Volume (MCV), Mean Corpuscular Haemoglobin (MCH) and Mean Corpuscular Haemoglobin Concentration (MCHC) was observed. At 1669/1650 mg/kg bw/day, ↓ body weight, food, and water consumption, ↓Hb and MCH level and ↑ relative liver weight, relative kidney weight, absolute bladder weight and abnormal growth in the bladder mucosa was observed. At 761/ 803 mg/kg bw/day, changes in liver and kidney weight were observed. | NOAEL: 761 mg/kg bw/day | Iguchi et al., 1984 in (EC, 2023; ECHA, 2023b; ECHA RAC, 2022)/KL2; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"13-week dietary study in F344/DuCrj Rats (10/sex/group); similar to OECD TG 408 | 0, 0.156, 0.313, 0.625, 1.25, and 2.5% OPP equivalent to 0, 182, 391, 761, 1669, and 2798 mg/kg bw/day in males and 0, 202, 411, 803, 1650, and 3014 mg/kg bw/day in females | At 2798/3014 mg/kg bw/day, ↓ body weight, terminal body weight, food and water consumption...","duration":"13-week","effect":"Unlabeled table on page 66: 13-week dietary study in F344/DuCrj Rats (10/sex/group); similar to OECD TG 408 | 0, 0.156, 0.313, 0.625, 1.25, and 2.5% OPP equivalent to 0, 182, 391, 761, 1669, and 2798 mg/kg bw/day in males and 0, 202, 411, 803, 1650, and 3014 mg/kg bw/day in females | At 2798/3014 mg/kg bw/day, ↓ body weight, terminal body weight, food and water consumption, changes in organ weight, and histopathological changes in the kidney and bladder, and ↓ Red Blood Count (RBC), Haemoglobin (Hb), Mean Corpuscular Volume (MCV), Mean Corpuscular Haemoglobin (MCH) and Mean Corpuscular Haemoglobin Concentration (MCHC) was observed. At 1669/1650 mg/kg bw/day, ↓ body weight, food, and water consumption, ↓Hb and MCH level and ↑ relative liver weight, relative kidney weight, absolute bladder weight and abnormal growth in the bladder mucosa was observed. At 761/ 803 mg/kg bw/day, changes in liver and kidney weight were observed. | NOAEL: 761 mg/kg bw/day | Iguchi et al., 1984 in (EC, 2023; ECHA, 2023b; ECHA RAC, 2022)/KL2","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"%","noael_value":"2.5","page":66,"route":"oral","species":"rat","study_id":"sccs_o_291_noael_090"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 2000 mg/kg bw/day rat oral 3 months - SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=2000; DOSE=3 months dietary study (strain not specified) in rats (12/sex/group); no guideline | 0, 100, 300, 1000 and 2000 mg/kg bw/day | At 2000 mg/kg bw/day, slight growth retardation, ↑ liver, kidney and. in some rats (no numerical data available) At 1000 mg/kg bw/day, ↑ liver, kidney, and spleen weight in some rats (no numerical data available). | NOAEL:; EFFECT=Unlabeled table on page 66: 3 months dietary study (strain not specified) in rats (12/sex/group); no guideline | 0, 100, 300, 1000 and 2000 mg/kg bw/day | At 2000 mg/kg bw/day, slight growth retardation, ↑ liver, kidney and. in some rats (no numerical data available) At 1000 mg/kg bw/day, ↑ liver, kidney, and spleen weight in some rats (no numerical data available). | NOAEL: 1000 mg/kg bw/day | Hodge et al., 1952 in (ECHA RAC, 2022)/KL4; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"3 months dietary study (strain not specified) in rats (12/sex/group); no guideline | 0, 100, 300, 1000 and 2000 mg/kg bw/day | At 2000 mg/kg bw/day, slight growth retardation, ↑ liver, kidney and. in some rats (no numerical data available) At 1000 mg/kg bw/day, ↑ liver, kidney, and spleen weight in some rats (no numerical data available). | NOAEL:","duration":"3 months","effect":"Unlabeled table on page 66: 3 months dietary study (strain not specified) in rats (12/sex/group); no guideline | 0, 100, 300, 1000 and 2000 mg/kg bw/day | At 2000 mg/kg bw/day, slight growth retardation, ↑ liver, kidney and. in some rats (no numerical data available) At 1000 mg/kg bw/day, ↑ liver, kidney, and spleen weight in some rats (no numerical data available). | NOAEL: 1000 mg/kg bw/day | Hodge et al., 1952 in (ECHA RAC, 2022)/KL4","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"2000","page":66,"route":"oral","species":"rat","study_id":"sccs_o_291_noael_091"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 500 mg/kg bw/day rat oral 6 months - SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=500; DOSE=6 months gavage study (strain not specified) in rats | 0, 50, 100, 200 and 500 mg/kg bw/day 5 days/week | At 500 mg/kg bw/day ↑ liver and kidney | NOAEL:; EFFECT=Unlabeled table on page 66: 6 months gavage study (strain not specified) in rats | 0, 50, 100, 200 and 500 mg/kg bw/day 5 days/week | At 500 mg/kg bw/day ↑ liver and kidney | NOAEL: 200 mg/kg bw/day | Hodge et al., 1952 in (ECHA, 2023b;; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"6 months gavage study (strain not specified) in rats | 0, 50, 100, 200 and 500 mg/kg bw/day 5 days/week | At 500 mg/kg bw/day ↑ liver and kidney | NOAEL:","duration":"6 months","effect":"Unlabeled table on page 66: 6 months gavage study (strain not specified) in rats | 0, 50, 100, 200 and 500 mg/kg bw/day 5 days/week | At 500 mg/kg bw/day ↑ liver and kidney | NOAEL: 200 mg/kg bw/day | Hodge et al., 1952 in (ECHA, 2023b;","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"500","page":66,"route":"oral","species":"rat","study_id":"sccs_o_291_noael_092"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 761 mg/kg bw/day rat oral 13-week - SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=761; DOSE=13-week dietary study in F344/DuCrj Rats (10/sex/group); similar to OECD TG 408 | 0, 0.156, 0.313, 0.625, 1.25, and 2.5% OPP equivalent to 0, 182, 391, 761, 1669, and 2798 mg/kg bw/day in males and 0, 202, 411, 803, 1650, and 3014 mg/kg bw/day in females | At 2798/3014 mg/kg bw/day, ↓ body weight, terminal body weight, food and water consumption...; EFFECT=Unlabeled table on page 66: 13-week dietary study in F344/DuCrj Rats (10/sex/group); similar to OECD TG 408 | 0, 0.156, 0.313, 0.625, 1.25, and 2.5% OPP equivalent to 0, 182, 391, 761, 1669, and 2798 mg/kg bw/day in males and 0, 202, 411, 803, 1650, and 3014 mg/kg bw/day in females | At 2798/3014 mg/kg bw/day, ↓ body weight, terminal body weight, food and water consumption, changes in organ weight, and histopathological changes in the kidney and bladder, and ↓ Red Blood Count (RBC), Haemoglobin (Hb), Mean Corpuscular Volume (MCV), Mean Corpuscular Haemoglobin (MCH) and Mean Corpuscular Haemoglobin Concentration (MCHC) was observed. At 1669/1650 mg/kg bw/day, ↓ body weight, food, and water consumption, ↓Hb and MCH level and ↑ relative liver weight, relative kidney weight, absolute bladder weight and abnormal growth in the bladder mucosa was observed. At 761/ 803 mg/kg bw/day, changes in liver and kidney weight were observed. | NOAEL: 761 mg/kg bw/day | Iguchi et al., 1984 in (EC, 2023; ECHA, 2023b; ECHA RAC, 2022)/KL2; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"13-week dietary study in F344/DuCrj Rats (10/sex/group); similar to OECD TG 408 | 0, 0.156, 0.313, 0.625, 1.25, and 2.5% OPP equivalent to 0, 182, 391, 761, 1669, and 2798 mg/kg bw/day in males and 0, 202, 411, 803, 1650, and 3014 mg/kg bw/day in females | At 2798/3014 mg/kg bw/day, ↓ body weight, terminal body weight, food and water consumption...","duration":"13-week","effect":"Unlabeled table on page 66: 13-week dietary study in F344/DuCrj Rats (10/sex/group); similar to OECD TG 408 | 0, 0.156, 0.313, 0.625, 1.25, and 2.5% OPP equivalent to 0, 182, 391, 761, 1669, and 2798 mg/kg bw/day in males and 0, 202, 411, 803, 1650, and 3014 mg/kg bw/day in females | At 2798/3014 mg/kg bw/day, ↓ body weight, terminal body weight, food and water consumption, changes in organ weight, and histopathological changes in the kidney and bladder, and ↓ Red Blood Count (RBC), Haemoglobin (Hb), Mean Corpuscular Volume (MCV), Mean Corpuscular Haemoglobin (MCH) and Mean Corpuscular Haemoglobin Concentration (MCHC) was observed. At 1669/1650 mg/kg bw/day, ↓ body weight, food, and water consumption, ↓Hb and MCH level and ↑ relative liver weight, relative kidney weight, absolute bladder weight and abnormal growth in the bladder mucosa was observed. At 761/ 803 mg/kg bw/day, changes in liver and kidney weight were observed. | NOAEL: 761 mg/kg bw/day | Iguchi et al., 1984 in (EC, 2023; ECHA, 2023b; ECHA RAC, 2022)/KL2","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"761","page":66,"route":"oral","species":"rat","study_id":"sccs_o_291_noael_093"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 1000 mg/kg bw/day rat oral 3 months - SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=1000; DOSE=3 months dietary study (strain not specified) in rats (12/sex/group); no guideline | 0, 100, 300, 1000 and 2000 mg/kg bw/day | At 2000 mg/kg bw/day, slight growth retardation, ↑ liver, kidney and. in some rats (no numerical data available) At 1000 mg/kg bw/day, ↑ liver, kidney, and spleen weight in some rats (no numerical data available). | NOAEL:; EFFECT=Unlabeled table on page 66: 3 months dietary study (strain not specified) in rats (12/sex/group); no guideline | 0, 100, 300, 1000 and 2000 mg/kg bw/day | At 2000 mg/kg bw/day, slight growth retardation, ↑ liver, kidney and. in some rats (no numerical data available) At 1000 mg/kg bw/day, ↑ liver, kidney, and spleen weight in some rats (no numerical data available). | NOAEL: 1000 mg/kg bw/day | Hodge et al., 1952 in (ECHA RAC, 2022)/KL4; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"3 months dietary study (strain not specified) in rats (12/sex/group); no guideline | 0, 100, 300, 1000 and 2000 mg/kg bw/day | At 2000 mg/kg bw/day, slight growth retardation, ↑ liver, kidney and. in some rats (no numerical data available) At 1000 mg/kg bw/day, ↑ liver, kidney, and spleen weight in some rats (no numerical data available). | NOAEL:","duration":"3 months","effect":"Unlabeled table on page 66: 3 months dietary study (strain not specified) in rats (12/sex/group); no guideline | 0, 100, 300, 1000 and 2000 mg/kg bw/day | At 2000 mg/kg bw/day, slight growth retardation, ↑ liver, kidney and. in some rats (no numerical data available) At 1000 mg/kg bw/day, ↑ liver, kidney, and spleen weight in some rats (no numerical data available). | NOAEL: 1000 mg/kg bw/day | Hodge et al., 1952 in (ECHA RAC, 2022)/KL4","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"1000","page":66,"route":"oral","species":"rat","study_id":"sccs_o_291_noael_094"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 200 mg/kg bw/day rat oral 6 months - SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=200; DOSE=6 months gavage study (strain not specified) in rats | 0, 50, 100, 200 and 500 mg/kg bw/day 5 days/week | At 500 mg/kg bw/day ↑ liver and kidney | NOAEL:; EFFECT=Unlabeled table on page 66: 6 months gavage study (strain not specified) in rats | 0, 50, 100, 200 and 500 mg/kg bw/day 5 days/week | At 500 mg/kg bw/day ↑ liver and kidney | NOAEL: 200 mg/kg bw/day | Hodge et al., 1952 in (ECHA, 2023b;; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"6 months gavage study (strain not specified) in rats | 0, 50, 100, 200 and 500 mg/kg bw/day 5 days/week | At 500 mg/kg bw/day ↑ liver and kidney | NOAEL:","duration":"6 months","effect":"Unlabeled table on page 66: 6 months gavage study (strain not specified) in rats | 0, 50, 100, 200 and 500 mg/kg bw/day 5 days/week | At 500 mg/kg bw/day ↑ liver and kidney | NOAEL: 200 mg/kg bw/day | Hodge et al., 1952 in (ECHA, 2023b;","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"200","page":66,"route":"oral","species":"rat","study_id":"sccs_o_291_noael_095"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 67 - - - - - SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=unclear:Unlabeled table on page 67: Study type, Species | Doses | Key findings | NOAEL or LOAEL | Reference#/ KL rating; EFFECT=Unlabeled table on page 67: Study type, Species | Doses | Key findings | NOAEL or LOAEL | Reference#/ KL rating; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"","duration":"","effect":"Unlabeled table on page 67: Study type, Species | Doses | Key findings | NOAEL or LOAEL | Reference#/ KL rating","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"","noael_value":"unclear:Unlabeled table on page 67: Study type, Species | Doses | Key findings | NOAEL or LOAEL | Reference#/ KL rating","page":67,"route":"","species":"","study_id":"sccs_o_291_noael_096"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 500 mg/kg bw/day dog oral 1-year - SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=500; DOSE=Similar to OECD TG 409 | 0, 20, 200, and 500 mg/kg bw/day | At 500 mg/kg bw/day, ↑ kidney weight in males (no numerical data) was observed. | NOAEL:; EFFECT=Unlabeled table on page 67: 1-year dietary study (strain not specified) in dogs (1- 2/sex/group); Similar to OECD TG 409 | 0, 20, 200, and 500 mg/kg bw/day | At 500 mg/kg bw/day, ↑ kidney weight in males (no numerical data) was observed. | NOAEL: 200 mg/kg bw/day | Hodge et al., 1952 in (EC, 2023; ECHA, 2023b; ECHA RAC, 2022)/KL2; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"Similar to OECD TG 409 | 0, 20, 200, and 500 mg/kg bw/day | At 500 mg/kg bw/day, ↑ kidney weight in males (no numerical data) was observed. | NOAEL:","duration":"1-year","effect":"Unlabeled table on page 67: 1-year dietary study (strain not specified) in dogs (1- 2/sex/group); Similar to OECD TG 409 | 0, 20, 200, and 500 mg/kg bw/day | At 500 mg/kg bw/day, ↑ kidney weight in males (no numerical data) was observed. | NOAEL: 200 mg/kg bw/day | Hodge et al., 1952 in (EC, 2023; ECHA, 2023b; ECHA RAC, 2022)/KL2","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"500","page":67,"route":"oral","species":"dog","study_id":"sccs_o_291_noael_097"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 300 mg/kg bw/day dog oral 1 year - SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=300; DOSE=Similar to OECD TG 409 | 0, 30, 100, and 300 mg/kg bw/day | At 300 mg/kg bw/day, ↓ terminal body weight in males, ↓ creatinine phosphokinase (CPK) in females and gross pathological changes such as dark regions in the pulmonary parenchyma, which is consistent with administration of test material into the lungs, resulting in anoxia/shock. | NOAEL:; EFFECT=Unlabeled table on page 67: 1 year gavage study in Beagle dogs (4/sex/group); Similar to OECD TG 409 | 0, 30, 100, and 300 mg/kg bw/day | At 300 mg/kg bw/day, ↓ terminal body weight in males, ↓ creatinine phosphokinase (CPK) in females and gross pathological changes such as dark regions in the pulmonary parenchyma, which is consistent with administration of test material into the lungs, resulting in anoxia/shock. | NOAEL: 100 mg/kg bw/day | Cosse et al. 1990 in (EC, 2023; ECHA, 2023b; ECHA RAC, 2022)/KL1; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"Similar to OECD TG 409 | 0, 30, 100, and 300 mg/kg bw/day | At 300 mg/kg bw/day, ↓ terminal body weight in males, ↓ creatinine phosphokinase (CPK) in females and gross pathological changes such as dark regions in the pulmonary parenchyma, which is consistent with administration of test material into the lungs, resulting in anoxia/shock. | NOAEL:","duration":"1 year","effect":"Unlabeled table on page 67: 1 year gavage study in Beagle dogs (4/sex/group); Similar to OECD TG 409 | 0, 30, 100, and 300 mg/kg bw/day | At 300 mg/kg bw/day, ↓ terminal body weight in males, ↓ creatinine phosphokinase (CPK) in females and gross pathological changes such as dark regions in the pulmonary parenchyma, which is consistent with administration of test material into the lungs, resulting in anoxia/shock. | NOAEL: 100 mg/kg bw/day | Cosse et al. 1990 in (EC, 2023; ECHA, 2023b; ECHA RAC, 2022)/KL1","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"300","page":67,"route":"oral","species":"dog","study_id":"sccs_o_291_noael_098"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 4 % mouse oral 13-week - SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=4.0; DOSE=13-week dietary study in B6C3F1 mice | 0, 0.25, 0.5, 1.0, 2.0 and 4.0% (correspond- ding to | At 5375/6349 mg/kg bw/day, ↓ body weight, ↓ mean food | NOAEL:; EFFECT=Unlabeled table on page 67: 13-week dietary study in B6C3F1 mice | 0, 0.25, 0.5, 1.0, 2.0 and 4.0% (correspond- ding to | At 5375/6349 mg/kg bw/day, ↓ body weight, ↓ mean food | NOAEL: 3529 and 4294 mg/kg bw/day for males | Shibata et al., 1981, 1985 in (SCCS, 2015)/KL2; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"13-week dietary study in B6C3F1 mice | 0, 0.25, 0.5, 1.0, 2.0 and 4.0% (correspond- ding to | At 5375/6349 mg/kg bw/day, ↓ body weight, ↓ mean food | NOAEL:","duration":"13-week","effect":"Unlabeled table on page 67: 13-week dietary study in B6C3F1 mice | 0, 0.25, 0.5, 1.0, 2.0 and 4.0% (correspond- ding to | At 5375/6349 mg/kg bw/day, ↓ body weight, ↓ mean food | NOAEL: 3529 and 4294 mg/kg bw/day for males | Shibata et al., 1981, 1985 in (SCCS, 2015)/KL2","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"%","noael_value":"4.0","page":67,"route":"oral","species":"mouse","study_id":"sccs_o_291_noael_099"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 200 mg/kg bw/day dog oral 1-year - SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=200; DOSE=Similar to OECD TG 409 | 0, 20, 200, and 500 mg/kg bw/day | At 500 mg/kg bw/day, ↑ kidney weight in males (no numerical data) was observed. | NOAEL:; EFFECT=Unlabeled table on page 67: 1-year dietary study (strain not specified) in dogs (1- 2/sex/group); Similar to OECD TG 409 | 0, 20, 200, and 500 mg/kg bw/day | At 500 mg/kg bw/day, ↑ kidney weight in males (no numerical data) was observed. | NOAEL: 200 mg/kg bw/day | Hodge et al., 1952 in (EC, 2023; ECHA, 2023b; ECHA RAC, 2022)/KL2; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"Similar to OECD TG 409 | 0, 20, 200, and 500 mg/kg bw/day | At 500 mg/kg bw/day, ↑ kidney weight in males (no numerical data) was observed. | NOAEL:","duration":"1-year","effect":"Unlabeled table on page 67: 1-year dietary study (strain not specified) in dogs (1- 2/sex/group); Similar to OECD TG 409 | 0, 20, 200, and 500 mg/kg bw/day | At 500 mg/kg bw/day, ↑ kidney weight in males (no numerical data) was observed. | NOAEL: 200 mg/kg bw/day | Hodge et al., 1952 in (EC, 2023; ECHA, 2023b; ECHA RAC, 2022)/KL2","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"200","page":67,"route":"oral","species":"dog","study_id":"sccs_o_291_noael_100"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 100 mg/kg bw/day dog oral 1 year - SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=100; DOSE=Similar to OECD TG 409 | 0, 30, 100, and 300 mg/kg bw/day | At 300 mg/kg bw/day, ↓ terminal body weight in males, ↓ creatinine phosphokinase (CPK) in females and gross pathological changes such as dark regions in the pulmonary parenchyma, which is consistent with administration of test material into the lungs, resulting in anoxia/shock. | NOAEL:; EFFECT=Unlabeled table on page 67: 1 year gavage study in Beagle dogs (4/sex/group); Similar to OECD TG 409 | 0, 30, 100, and 300 mg/kg bw/day | At 300 mg/kg bw/day, ↓ terminal body weight in males, ↓ creatinine phosphokinase (CPK) in females and gross pathological changes such as dark regions in the pulmonary parenchyma, which is consistent with administration of test material into the lungs, resulting in anoxia/shock. | NOAEL: 100 mg/kg bw/day | Cosse et al. 1990 in (EC, 2023; ECHA, 2023b; ECHA RAC, 2022)/KL1; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"Similar to OECD TG 409 | 0, 30, 100, and 300 mg/kg bw/day | At 300 mg/kg bw/day, ↓ terminal body weight in males, ↓ creatinine phosphokinase (CPK) in females and gross pathological changes such as dark regions in the pulmonary parenchyma, which is consistent with administration of test material into the lungs, resulting in anoxia/shock. | NOAEL:","duration":"1 year","effect":"Unlabeled table on page 67: 1 year gavage study in Beagle dogs (4/sex/group); Similar to OECD TG 409 | 0, 30, 100, and 300 mg/kg bw/day | At 300 mg/kg bw/day, ↓ terminal body weight in males, ↓ creatinine phosphokinase (CPK) in females and gross pathological changes such as dark regions in the pulmonary parenchyma, which is consistent with administration of test material into the lungs, resulting in anoxia/shock. | NOAEL: 100 mg/kg bw/day | Cosse et al. 1990 in (EC, 2023; ECHA, 2023b; ECHA RAC, 2022)/KL1","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"100","page":67,"route":"oral","species":"dog","study_id":"sccs_o_291_noael_101"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 2000 mg/kg bw/day rat oral 4-week - SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=2000; DOSE=4-week dietary study in male F344 rats (group not specified); no guideline | 0 and 2% (correspond- ding to a weighted average dose of 2000 mg/kg bw/day) | At 2000 mg/kg bw/day, an ↑ in dark- stained cells and a few mitoses were observed.; LOAEL_VALUE=2000 mg/kg bw/day; EFFECT=Unlabeled table on page 67: 4-week dietary study in male F344 rats (group not specified); no guideline | 0 and 2% (correspond- ding to a weighted average dose of 2000 mg/kg bw/day) | At 2000 mg/kg bw/day, an ↑ in dark- stained cells and a few mitoses were observed. The authors suggest that these changes are the prodromal stage of the tumours induced by SOPP after longer treatment periods. Only bladder examined (once/week by transmission electron microscopy (TEM). | LOAEL: 2000 mg/kg bw/day | Fukumori et al. in (SCCS, 2015)/KL2; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"4-week dietary study in male F344 rats (group not specified); no guideline | 0 and 2% (correspond- ding to a weighted average dose of 2000 mg/kg bw/day) | At 2000 mg/kg bw/day, an ↑ in dark- stained cells and a few mitoses were observed.","duration":"4-week","effect":"Unlabeled table on page 67: 4-week dietary study in male F344 rats (group not specified); no guideline | 0 and 2% (correspond- ding to a weighted average dose of 2000 mg/kg bw/day) | At 2000 mg/kg bw/day, an ↑ in dark- stained cells and a few mitoses were observed. The authors suggest that these changes are the prodromal stage of the tumours induced by SOPP after longer treatment periods. Only bladder examined (once/week by transmission electron microscopy (TEM). | LOAEL: 2000 mg/kg bw/day | Fukumori et al. in (SCCS, 2015)/KL2","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"2000 mg/kg bw/day","noael_unit":"mg/kg bw/day","noael_value":"2000","page":67,"route":"oral","species":"rat","study_id":"sccs_o_291_noael_102"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 4294 mg/kg bw/day mouse oral 13-week - SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=4294; DOSE=13-week dietary study in B6C3F1 mice | 0, 0.25, 0.5, 1.0, 2.0 and 4.0% (correspond- ding to | At 5375/6349 mg/kg bw/day, ↓ body weight, ↓ mean food | NOAEL:; EFFECT=Unlabeled table on page 67: 13-week dietary study in B6C3F1 mice | 0, 0.25, 0.5, 1.0, 2.0 and 4.0% (correspond- ding to | At 5375/6349 mg/kg bw/day, ↓ body weight, ↓ mean food | NOAEL: 3529 and 4294 mg/kg bw/day for males | Shibata et al., 1981, 1985 in (SCCS, 2015)/KL2; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"13-week dietary study in B6C3F1 mice | 0, 0.25, 0.5, 1.0, 2.0 and 4.0% (correspond- ding to | At 5375/6349 mg/kg bw/day, ↓ body weight, ↓ mean food | NOAEL:","duration":"13-week","effect":"Unlabeled table on page 67: 13-week dietary study in B6C3F1 mice | 0, 0.25, 0.5, 1.0, 2.0 and 4.0% (correspond- ding to | At 5375/6349 mg/kg bw/day, ↓ body weight, ↓ mean food | NOAEL: 3529 and 4294 mg/kg bw/day for males | Shibata et al., 1981, 1985 in (SCCS, 2015)/KL2","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"4294","page":67,"route":"oral","species":"mouse","study_id":"sccs_o_291_noael_103"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 68 - - - - - SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=unclear:Unlabeled table on page 68: Study type, Species | Doses | Key findings | NOAEL or LOAEL | Reference#/ KL rating; EFFECT=Unlabeled table on page 68: Study type, Species | Doses | Key findings | NOAEL or LOAEL | Reference#/ KL rating; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"","duration":"","effect":"Unlabeled table on page 68: Study type, Species | Doses | Key findings | NOAEL or LOAEL | Reference#/ KL rating","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"","noael_value":"unclear:Unlabeled table on page 68: Study type, Species | Doses | Key findings | NOAEL or LOAEL | Reference#/ KL rating","page":68,"route":"","species":"","study_id":"sccs_o_291_noael_104"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 4 % rat oral 13-week - SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=4; DOSE=13-week dietary study in F344 rats (10/sex/group); no guideline | 0, 0.125, 0.25, 0.5, 1, 2 and 4% (corresponding to 0, 85, 177, 353, 706, 1384 and 2487 in males and 0, 87, 177, 352, 694, 1338 and 2431 mg/kg bw/day in females, respectively) | At 2431/2487 mg/kg bw/day, ↓ body weight, moderate pyelonephritis was observed.; EFFECT=Unlabeled table on page 68: 13-week dietary study in F344 rats (10/sex/group); no guideline | 0, 0.125, 0.25, 0.5, 1, 2 and 4% (corresponding to 0, 85, 177, 353, 706, 1384 and 2487 in males and 0, 87, 177, 352, 694, 1338 and 2431 mg/kg bw/day in females, respectively) | At 2431/2487 mg/kg bw/day, ↓ body weight, moderate pyelonephritis was observed. At 1338/1384 mg/kg bw/day, ↓ body weight was observed. At 694/706 mg/kg bw/day, ↓ body weight was observed. | NOAEL: 353 mg/kg bw/day | Iguchi et al., 1979 in (SCCS, 2015)/KL2; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"13-week dietary study in F344 rats (10/sex/group); no guideline | 0, 0.125, 0.25, 0.5, 1, 2 and 4% (corresponding to 0, 85, 177, 353, 706, 1384 and 2487 in males and 0, 87, 177, 352, 694, 1338 and 2431 mg/kg bw/day in females, respectively) | At 2431/2487 mg/kg bw/day, ↓ body weight, moderate pyelonephritis was observed.","duration":"13-week","effect":"Unlabeled table on page 68: 13-week dietary study in F344 rats (10/sex/group); no guideline | 0, 0.125, 0.25, 0.5, 1, 2 and 4% (corresponding to 0, 85, 177, 353, 706, 1384 and 2487 in males and 0, 87, 177, 352, 694, 1338 and 2431 mg/kg bw/day in females, respectively) | At 2431/2487 mg/kg bw/day, ↓ body weight, moderate pyelonephritis was observed. At 1338/1384 mg/kg bw/day, ↓ body weight was observed. At 694/706 mg/kg bw/day, ↓ body weight was observed. | NOAEL: 353 mg/kg bw/day | Iguchi et al., 1979 in (SCCS, 2015)/KL2","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"%","noael_value":"4","page":68,"route":"oral","species":"rat","study_id":"sccs_o_291_noael_105"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 2.5 % rat oral 13-week - SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=2.5; DOSE=13-week dietary study in F344 rats (20/sex/group); no guideline | 0, 0.625, 1.25, and 2.5% (correspond- ding to weighted average doses of 0, 625 1250 and 2500 in males and 0, 706, 1411 and 2823 mg/kg bw/day in females, respectively) | At 2500/2823 mg/kg bw/day, ↓ body weight gain was observed.; EFFECT=Unlabeled table on page 68: 13-week dietary study in F344 rats (20/sex/group); no guideline | 0, 0.625, 1.25, and 2.5% (correspond- ding to weighted average doses of 0, 625 1250 and 2500 in males and 0, 706, 1411 and 2823 mg/kg bw/day in females, respectively) | At 2500/2823 mg/kg bw/day, ↓ body weight gain was observed. At 1250/1411 mg/kg bw/day, ↓ body weight gain was observed. | NOAEL: 625 mg/kg bw/day | Nakamura et al., 1981 in (SCCS, 2015)/KL2; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"13-week dietary study in F344 rats (20/sex/group); no guideline | 0, 0.625, 1.25, and 2.5% (correspond- ding to weighted average doses of 0, 625 1250 and 2500 in males and 0, 706, 1411 and 2823 mg/kg bw/day in females, respectively) | At 2500/2823 mg/kg bw/day, ↓ body weight gain was observed.","duration":"13-week","effect":"Unlabeled table on page 68: 13-week dietary study in F344 rats (20/sex/group); no guideline | 0, 0.625, 1.25, and 2.5% (correspond- ding to weighted average doses of 0, 625 1250 and 2500 in males and 0, 706, 1411 and 2823 mg/kg bw/day in females, respectively) | At 2500/2823 mg/kg bw/day, ↓ body weight gain was observed. At 1250/1411 mg/kg bw/day, ↓ body weight gain was observed. | NOAEL: 625 mg/kg bw/day | Nakamura et al., 1981 in (SCCS, 2015)/KL2","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"%","noael_value":"2.5","page":68,"route":"oral","species":"rat","study_id":"sccs_o_291_noael_106"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 5375 mg/kg bw/day - - - - SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=5375; DOSE=(10/sex/group); no guideline | weighted average doses of 0, 451, 902, 1581, 3529 and 5375 mg/kg bw/day in males and 0, 488, 976, 1926, 4294 and 6349 mg/kg bw/day in females, respectively) | intake, ↑ urinary pH value and ↓ urine density. | and females, respectively; EFFECT=Unlabeled table on page 68: (10/sex/group); no guideline | weighted average doses of 0, 451, 902, 1581, 3529 and 5375 mg/kg bw/day in males and 0, 488, 976, 1926, 4294 and 6349 mg/kg bw/day in females, respectively) | intake, ↑ urinary pH value and ↓ urine density. | and females, respectively; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"(10/sex/group); no guideline | weighted average doses of 0, 451, 902, 1581, 3529 and 5375 mg/kg bw/day in males and 0, 488, 976, 1926, 4294 and 6349 mg/kg bw/day in females, respectively) | intake, ↑ urinary pH value and ↓ urine density. | and females, respectively","duration":"","effect":"Unlabeled table on page 68: (10/sex/group); no guideline | weighted average doses of 0, 451, 902, 1581, 3529 and 5375 mg/kg bw/day in males and 0, 488, 976, 1926, 4294 and 6349 mg/kg bw/day in females, respectively) | intake, ↑ urinary pH value and ↓ urine density. | and females, respectively","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"5375","page":68,"route":"","species":"","study_id":"sccs_o_291_noael_107"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 353 mg/kg bw/day rat oral 13-week - SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=353; DOSE=13-week dietary study in F344 rats (10/sex/group); no guideline | 0, 0.125, 0.25, 0.5, 1, 2 and 4% (corresponding to 0, 85, 177, 353, 706, 1384 and 2487 in males and 0, 87, 177, 352, 694, 1338 and 2431 mg/kg bw/day in females, respectively) | At 2431/2487 mg/kg bw/day, ↓ body weight, moderate pyelonephritis was observed.; EFFECT=Unlabeled table on page 68: 13-week dietary study in F344 rats (10/sex/group); no guideline | 0, 0.125, 0.25, 0.5, 1, 2 and 4% (corresponding to 0, 85, 177, 353, 706, 1384 and 2487 in males and 0, 87, 177, 352, 694, 1338 and 2431 mg/kg bw/day in females, respectively) | At 2431/2487 mg/kg bw/day, ↓ body weight, moderate pyelonephritis was observed. At 1338/1384 mg/kg bw/day, ↓ body weight was observed. At 694/706 mg/kg bw/day, ↓ body weight was observed. | NOAEL: 353 mg/kg bw/day | Iguchi et al., 1979 in (SCCS, 2015)/KL2; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"13-week dietary study in F344 rats (10/sex/group); no guideline | 0, 0.125, 0.25, 0.5, 1, 2 and 4% (corresponding to 0, 85, 177, 353, 706, 1384 and 2487 in males and 0, 87, 177, 352, 694, 1338 and 2431 mg/kg bw/day in females, respectively) | At 2431/2487 mg/kg bw/day, ↓ body weight, moderate pyelonephritis was observed.","duration":"13-week","effect":"Unlabeled table on page 68: 13-week dietary study in F344 rats (10/sex/group); no guideline | 0, 0.125, 0.25, 0.5, 1, 2 and 4% (corresponding to 0, 85, 177, 353, 706, 1384 and 2487 in males and 0, 87, 177, 352, 694, 1338 and 2431 mg/kg bw/day in females, respectively) | At 2431/2487 mg/kg bw/day, ↓ body weight, moderate pyelonephritis was observed. At 1338/1384 mg/kg bw/day, ↓ body weight was observed. At 694/706 mg/kg bw/day, ↓ body weight was observed. | NOAEL: 353 mg/kg bw/day | Iguchi et al., 1979 in (SCCS, 2015)/KL2","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"353","page":68,"route":"oral","species":"rat","study_id":"sccs_o_291_noael_108"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 625 mg/kg bw/day rat oral 13-week - SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=625; DOSE=13-week dietary study in F344 rats (20/sex/group); no guideline | 0, 0.625, 1.25, and 2.5% (correspond- ding to weighted average doses of 0, 625 1250 and 2500 in males and 0, 706, 1411 and 2823 mg/kg bw/day in females, respectively) | At 2500/2823 mg/kg bw/day, ↓ body weight gain was observed.; EFFECT=Unlabeled table on page 68: 13-week dietary study in F344 rats (20/sex/group); no guideline | 0, 0.625, 1.25, and 2.5% (correspond- ding to weighted average doses of 0, 625 1250 and 2500 in males and 0, 706, 1411 and 2823 mg/kg bw/day in females, respectively) | At 2500/2823 mg/kg bw/day, ↓ body weight gain was observed. At 1250/1411 mg/kg bw/day, ↓ body weight gain was observed. | NOAEL: 625 mg/kg bw/day | Nakamura et al., 1981 in (SCCS, 2015)/KL2; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"13-week dietary study in F344 rats (20/sex/group); no guideline | 0, 0.625, 1.25, and 2.5% (correspond- ding to weighted average doses of 0, 625 1250 and 2500 in males and 0, 706, 1411 and 2823 mg/kg bw/day in females, respectively) | At 2500/2823 mg/kg bw/day, ↓ body weight gain was observed.","duration":"13-week","effect":"Unlabeled table on page 68: 13-week dietary study in F344 rats (20/sex/group); no guideline | 0, 0.625, 1.25, and 2.5% (correspond- ding to weighted average doses of 0, 625 1250 and 2500 in males and 0, 706, 1411 and 2823 mg/kg bw/day in females, respectively) | At 2500/2823 mg/kg bw/day, ↓ body weight gain was observed. At 1250/1411 mg/kg bw/day, ↓ body weight gain was observed. | NOAEL: 625 mg/kg bw/day | Nakamura et al., 1981 in (SCCS, 2015)/KL2","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"625","page":68,"route":"oral","species":"rat","study_id":"sccs_o_291_noael_109"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 2000 mg/kg bw/day rat oral 90-day - SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=2000; DOSE=90-day dietary study in male F344 rats (group not specified); no guideline | 0 and 2% (correspond- ding to weighted average doses of 2000 mg/kg bw/day) | At 2000 mg/kg bw/day, ↑ thickness of the bladder epithelium from Day 14 until end of study (classified as hyperplasia with accompanying increased frequency of cell infiltration) was observed. |...; LOAEL_VALUE=2000 mg/kg bw/day; EFFECT=Unlabeled table on page 68: 90-day dietary study in male F344 rats (group not specified); no guideline | 0 and 2% (correspond- ding to weighted average doses of 2000 mg/kg bw/day) | At 2000 mg/kg bw/day, ↑ thickness of the bladder epithelium from Day 14 until end of study (classified as hyperplasia with accompanying increased frequency of cell infiltration) was observed. | LOAEL: 2000 mg/kg bw/day | Reitz et al., 1983 in (SCCS, 2015)/KL2; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"90-day dietary study in male F344 rats (group not specified); no guideline | 0 and 2% (correspond- ding to weighted average doses of 2000 mg/kg bw/day) | At 2000 mg/kg bw/day, ↑ thickness of the bladder epithelium from Day 14 until end of study (classified as hyperplasia with accompanying increased frequency of cell infiltration) was observed. |...","duration":"90-day","effect":"Unlabeled table on page 68: 90-day dietary study in male F344 rats (group not specified); no guideline | 0 and 2% (correspond- ding to weighted average doses of 2000 mg/kg bw/day) | At 2000 mg/kg bw/day, ↑ thickness of the bladder epithelium from Day 14 until end of study (classified as hyperplasia with accompanying increased frequency of cell infiltration) was observed. | LOAEL: 2000 mg/kg bw/day | Reitz et al., 1983 in (SCCS, 2015)/KL2","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"2000 mg/kg bw/day","noael_unit":"mg/kg bw/day","noael_value":"2000","page":68,"route":"oral","species":"rat","study_id":"sccs_o_291_noael_110"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 69 - - - - - SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=unclear:Unlabeled table on page 69: Study type, Species | Doses | Key findings | NOAEL or LOAEL; EFFECT=Unlabeled table on page 69: Study type, Species | Doses | Key findings | NOAEL or LOAEL; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"","duration":"","effect":"Unlabeled table on page 69: Study type, Species | Doses | Key findings | NOAEL or LOAEL","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"","noael_value":"unclear:Unlabeled table on page 69: Study type, Species | Doses | Key findings | NOAEL or LOAEL","page":69,"route":"","species":"","study_id":"sccs_o_291_noael_111"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 240 mg/kg bw/day mouse dermal 4-week - SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=240; DOSE=4-week dermal toxicity study in Swiss Webster CFW mice (10/sex/group); no guideline | 0, 5.95, 11.4, 20.8, 35.7 and 55.5 mg / 0.1 mL acetone (corresponding to weighted average doses of 0, 383.1, 699.08, 1200 and 1865 mg/kg bw/day for males 0, 460.21, 839.70, 1441.20 and 2240.53 mg/kg bw/day for females respectively) 3 days/week | Ulcerative lesi...; LOAEL_VALUE=240 mg/kg bw/day; EFFECT=Unlabeled table on page 69: 4-week dermal toxicity study in Swiss Webster CFW mice (10/sex/group); no guideline | 0, 5.95, 11.4, 20.8, 35.7 and 55.5 mg / 0.1 mL acetone (corresponding to weighted average doses of 0, 383.1, 699.08, 1200 and 1865 mg/kg bw/day for males 0, 460.21, 839.70, 1441.20 and 2240.53 mg/kg bw/day for females respectively) 3 days/week | Ulcerative lesions at the site of application were observed in all mice that received ≤20.8 mg; in 6/10 males and 9/10 females that received 11.4 mg; in 2/10 males and 7/10 females that received 5.95 mg, and in 1/10 male and 1/10 female of control group | LOAEL (dermal toxicity): 5.95 mg (equivalent to 200 / 240 mg/kg bw/day for males and females, respectively) | NTP, 1986 in ECHA RAC, 2022/KL2; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"4-week dermal toxicity study in Swiss Webster CFW mice (10/sex/group); no guideline | 0, 5.95, 11.4, 20.8, 35.7 and 55.5 mg / 0.1 mL acetone (corresponding to weighted average doses of 0, 383.1, 699.08, 1200 and 1865 mg/kg bw/day for males 0, 460.21, 839.70, 1441.20 and 2240.53 mg/kg bw/day for females respectively) 3 days/week | Ulcerative lesi...","duration":"4-week","effect":"Unlabeled table on page 69: 4-week dermal toxicity study in Swiss Webster CFW mice (10/sex/group); no guideline | 0, 5.95, 11.4, 20.8, 35.7 and 55.5 mg / 0.1 mL acetone (corresponding to weighted average doses of 0, 383.1, 699.08, 1200 and 1865 mg/kg bw/day for males 0, 460.21, 839.70, 1441.20 and 2240.53 mg/kg bw/day for females respectively) 3 days/week | Ulcerative lesions at the site of application were observed in all mice that received ≤20.8 mg; in 6/10 males and 9/10 females that received 11.4 mg; in 2/10 males and 7/10 females that received 5.95 mg, and in 1/10 male and 1/10 female of control group | LOAEL (dermal toxicity): 5.95 mg (equivalent to 200 / 240 mg/kg bw/day for males and females, respectively) | NTP, 1986 in ECHA RAC, 2022/KL2","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"240 mg/kg bw/day","noael_unit":"mg/kg bw/day","noael_value":"240","page":69,"route":"dermal","species":"mouse","study_id":"sccs_o_291_noael_113"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 70 - - - - - SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=unclear:Unlabeled table on page 70: Study type, Species | Doses | Critical effects | NOAEL or LOAEL | Reference#/ KL rating; EFFECT=Unlabeled table on page 70: Study type, Species | Doses | Critical effects | NOAEL or LOAEL | Reference#/ KL rating; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"","duration":"","effect":"Unlabeled table on page 70: Study type, Species | Doses | Critical effects | NOAEL or LOAEL | Reference#/ KL rating","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"","noael_value":"unclear:Unlabeled table on page 70: Study type, Species | Doses | Critical effects | NOAEL or LOAEL | Reference#/ KL rating","page":70,"route":"","species":"","study_id":"sccs_o_291_noael_115"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 71 - - - - - SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=unclear:Unlabeled table on page 71: Study type, Species | Doses | Critical effects | NOAEL or LOAEL | Reference#/ KL rating; EFFECT=Unlabeled table on page 71: Study type, Species | Doses | Critical effects | NOAEL or LOAEL | Reference#/ KL rating; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"","duration":"","effect":"Unlabeled table on page 71: Study type, Species | Doses | Critical effects | NOAEL or LOAEL | Reference#/ KL rating","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"","noael_value":"unclear:Unlabeled table on page 71: Study type, Species | Doses | Critical effects | NOAEL or LOAEL | Reference#/ KL rating","page":71,"route":"","species":"","study_id":"sccs_o_291_noael_118"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 72 - - - - - SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=unclear:Unlabeled table on page 72: Study type, Species | Doses | Critical effects | NOAEL or LOAEL | Reference#/ KL rating; EFFECT=Unlabeled table on page 72: Study type, Species | Doses | Critical effects | NOAEL or LOAEL | Reference#/ KL rating; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"","duration":"","effect":"Unlabeled table on page 72: Study type, Species | Doses | Critical effects | NOAEL or LOAEL | Reference#/ KL rating","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"","noael_value":"unclear:Unlabeled table on page 72: Study type, Species | Doses | Critical effects | NOAEL or LOAEL | Reference#/ KL rating","page":72,"route":"","species":"","study_id":"sccs_o_291_noael_121"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 73 - - - - - SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=unclear:Unlabeled table on page 73: Study type, Species | Doses | Critical effects | NOAEL or LOAEL | Reference#/ KL rating; EFFECT=Unlabeled table on page 73: Study type, Species | Doses | Critical effects | NOAEL or LOAEL | Reference#/ KL rating; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"","duration":"","effect":"Unlabeled table on page 73: Study type, Species | Doses | Critical effects | NOAEL or LOAEL | Reference#/ KL rating","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"","noael_value":"unclear:Unlabeled table on page 73: Study type, Species | Doses | Critical effects | NOAEL or LOAEL | Reference#/ KL rating","page":73,"route":"","species":"","study_id":"sccs_o_291_noael_123"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 74 - - - - - SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=unclear:Unlabeled table on page 74: Study type, Species | Doses | Critical effects | NOAEL or LOAEL | Reference#/ KL rating; EFFECT=Unlabeled table on page 74: Study type, Species | Doses | Critical effects | NOAEL or LOAEL | Reference#/ KL rating; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"","duration":"","effect":"Unlabeled table on page 74: Study type, Species | Doses | Critical effects | NOAEL or LOAEL | Reference#/ KL rating","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"","noael_value":"unclear:Unlabeled table on page 74: Study type, Species | Doses | Critical effects | NOAEL or LOAEL | Reference#/ KL rating","page":74,"route":"","species":"","study_id":"sccs_o_291_noael_126"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 75 - - - - - SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=unclear:Unlabeled table on page 75: Study type, Species | Doses | Critical effects | NOAEL or LOAEL | Reference#/ KL rating; EFFECT=Unlabeled table on page 75: Study type, Species | Doses | Critical effects | NOAEL or LOAEL | Reference#/ KL rating; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"","duration":"","effect":"Unlabeled table on page 75: Study type, Species | Doses | Critical effects | NOAEL or LOAEL | Reference#/ KL rating","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"","noael_value":"unclear:Unlabeled table on page 75: Study type, Species | Doses | Critical effects | NOAEL or LOAEL | Reference#/ KL rating","page":75,"route":"","species":"","study_id":"sccs_o_291_noael_131"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 76 - - - - - SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=unclear:Unlabeled table on page 76: Study type, Species | Doses | Critical effects | NOAEL or LOAEL | Reference#/ KL rating; EFFECT=Unlabeled table on page 76: Study type, Species | Doses | Critical effects | NOAEL or LOAEL | Reference#/ KL rating; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"","duration":"","effect":"Unlabeled table on page 76: Study type, Species | Doses | Critical effects | NOAEL or LOAEL | Reference#/ KL rating","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"","noael_value":"unclear:Unlabeled table on page 76: Study type, Species | Doses | Critical effects | NOAEL or LOAEL | Reference#/ KL rating","page":76,"route":"","species":"","study_id":"sccs_o_291_noael_134"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 93 - - - - - SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=unclear:Unlabeled table on page 93: Study type, Species | Doses | Key findings | NOAEL/ LOAEL | Reference / KL rating; EFFECT=Unlabeled table on page 93: Study type, Species | Doses | Key findings | NOAEL/ LOAEL | Reference / KL rating; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"","duration":"","effect":"Unlabeled table on page 93: Study type, Species | Doses | Key findings | NOAEL/ LOAEL | Reference / KL rating","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"","noael_value":"unclear:Unlabeled table on page 93: Study type, Species | Doses | Key findings | NOAEL/ LOAEL | Reference / KL rating","page":93,"route":"","species":"","study_id":"sccs_o_291_noael_136"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 94 - - - - - SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=unclear:Unlabeled table on page 94: Study type, Species | Doses | Key findings | NOAEL/ LOAEL | Reference / KL rating; EFFECT=Unlabeled table on page 94: Study type, Species | Doses | Key findings | NOAEL/ LOAEL | Reference / KL rating; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"","duration":"","effect":"Unlabeled table on page 94: Study type, Species | Doses | Key findings | NOAEL/ LOAEL | Reference / KL rating","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"","noael_value":"unclear:Unlabeled table on page 94: Study type, Species | Doses | Key findings | NOAEL/ LOAEL | Reference / KL rating","page":94,"route":"","species":"","study_id":"sccs_o_291_noael_143"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 2 % - oral 96-week - SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=2.0; DOSE=96-week dietary | 0, 0.5, 1.0 and 2.0% | At 3009/3081 mg/kg bw/day, | NOAEL | Hagiwara et; EFFECT=Unlabeled table on page 94: 96-week dietary | 0, 0.5, 1.0 and 2.0% | At 3009/3081 mg/kg bw/day, | NOAEL | Hagiwara et; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"96-week dietary | 0, 0.5, 1.0 and 2.0% | At 3009/3081 mg/kg bw/day, | NOAEL | Hagiwara et","duration":"96-week","effect":"Unlabeled table on page 94: 96-week dietary | 0, 0.5, 1.0 and 2.0% | At 3009/3081 mg/kg bw/day, | NOAEL | Hagiwara et","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"%","noael_value":"2.0","page":94,"route":"oral","species":"","study_id":"sccs_o_291_noael_145"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 248 mg/kg bw/day - - - - SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=248; DOSE=At 200/248 mg/kg bw/day, neoplastic changes in the urinary bladder, such as ↑ incidence of transitional cell carcinomas in males, ↓ body weight, body weight gain, food consumption and food efficiency, ↑clinical signs and gross pathological signs of toxicity. | and females, respectively | SCCS, 2015;; EFFECT=Unlabeled table on page 94: (50/sex/group); OECD TG 453 | males/females, respectively | cell carcinomas, ↑ incidence of papillomas in males was observed. Non-neoplastic changes in the urinary bladder and kidney were observed. At 200/248 mg/kg bw/day, neoplastic changes in the urinary bladder, such as ↑ incidence of transitional cell carcinomas in males, ↓ body weight, body weight gain, food consumption and food efficiency, ↑clinical signs and gross pathological signs of toxicity. | and females, respectively | SCCS, 2015; US EPA, 2013)/KL1; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"At 200/248 mg/kg bw/day, neoplastic changes in the urinary bladder, such as ↑ incidence of transitional cell carcinomas in males, ↓ body weight, body weight gain, food consumption and food efficiency, ↑clinical signs and gross pathological signs of toxicity. | and females, respectively | SCCS, 2015;","duration":"","effect":"Unlabeled table on page 94: (50/sex/group); OECD TG 453 | males/females, respectively | cell carcinomas, ↑ incidence of papillomas in males was observed. Non-neoplastic changes in the urinary bladder and kidney were observed. At 200/248 mg/kg bw/day, neoplastic changes in the urinary bladder, such as ↑ incidence of transitional cell carcinomas in males, ↓ body weight, body weight gain, food consumption and food efficiency, ↑clinical signs and gross pathological signs of toxicity. | and females, respectively | SCCS, 2015; US EPA, 2013)/KL1","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"248","page":94,"route":"","species":"","study_id":"sccs_o_291_noael_146"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 95 - - - - - SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=unclear:Unlabeled table on page 95: Study type, Species | Doses | Key findings | NOAEL/ LOAEL | Reference / KL rating; EFFECT=Unlabeled table on page 95: Study type, Species | Doses | Key findings | NOAEL/ LOAEL | Reference / KL rating; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"","duration":"","effect":"Unlabeled table on page 95: Study type, Species | Doses | Key findings | NOAEL/ LOAEL | Reference / KL rating","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"","noael_value":"unclear:Unlabeled table on page 95: Study type, Species | Doses | Key findings | NOAEL/ LOAEL | Reference / KL rating","page":95,"route":"","species":"","study_id":"sccs_o_291_noael_148"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 96 - - - - - SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=unclear:Unlabeled table on page 96: Study type, Species | Doses | Key findings | NOAEL/ LOAEL | Reference / KL rating; EFFECT=Unlabeled table on page 96: Study type, Species | Doses | Key findings | NOAEL/ LOAEL | Reference / KL rating; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"","duration":"","effect":"Unlabeled table on page 96: Study type, Species | Doses | Key findings | NOAEL/ LOAEL | Reference / KL rating","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"","noael_value":"unclear:Unlabeled table on page 96: Study type, Species | Doses | Key findings | NOAEL/ LOAEL | Reference / KL rating","page":96,"route":"","species":"","study_id":"sccs_o_291_noael_153"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 224 mg/kg bw/day rat - - - SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=224; DOSE=Unlabeled table on page 96: study in F344 rats (50/sex/group); no guideline | equivalent to 0, 270 and 770 mg/kg bw/day, respectively) and Females:; EFFECT=Unlabeled table on page 96: study in F344 rats (50/sex/group); no guideline | equivalent to 0, 270 and 770 mg/kg bw/day, respectively) and Females: 0, 5000 and 10000 ppm equivalent to 0, 224 and 466 mg/kg bw/day, respectively | pancreas and ↑ incidences of interstitial nephritis of the kidney were observed. At 466/770 mg/kg bw/day in the kidneys, both non- neoplastic changes (interstitial nephritis and pyelonephritis) and neoplastic changes (transitional cell papilloma and carcinoma) occurred in low incidences in the males, ↑ incidences of focal atrophy of pancreatic acinar cells in females and haematuria in males were observed. At 224/270 mg/kg bw/day, urinary bladder papillomas and/or carcinomas, ↑ incidences of interstitial nephritis of the kidney in both sexes and ↑ incidences of focal atrophy of pancreatic acinar cells in females were observed. At 466/770 mg/kg bw/day, ↓ body weights were observed in females. | and systemic toxicity): 224 mg/kg bw/day | 2015; Cal EPA, 2007; Health Canada, 2020)/KL2; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"Unlabeled table on page 96: study in F344 rats (50/sex/group); no guideline | equivalent to 0, 270 and 770 mg/kg bw/day, respectively) and Females:","duration":"","effect":"Unlabeled table on page 96: study in F344 rats (50/sex/group); no guideline | equivalent to 0, 270 and 770 mg/kg bw/day, respectively) and Females: 0, 5000 and 10000 ppm equivalent to 0, 224 and 466 mg/kg bw/day, respectively | pancreas and ↑ incidences of interstitial nephritis of the kidney were observed. At 466/770 mg/kg bw/day in the kidneys, both non- neoplastic changes (interstitial nephritis and pyelonephritis) and neoplastic changes (transitional cell papilloma and carcinoma) occurred in low incidences in the males, ↑ incidences of focal atrophy of pancreatic acinar cells in females and haematuria in males were observed. At 224/270 mg/kg bw/day, urinary bladder papillomas and/or carcinomas, ↑ incidences of interstitial nephritis of the kidney in both sexes and ↑ incidences of focal atrophy of pancreatic acinar cells in females were observed. At 466/770 mg/kg bw/day, ↓ body weights were observed in females. | and systemic toxicity): 224 mg/kg bw/day | 2015; Cal EPA, 2007; Health Canada, 2020)/KL2","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"224","page":96,"route":"","species":"rat","study_id":"sccs_o_291_noael_157"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 97 - - - - - SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=unclear:Unlabeled table on page 97: Study type, Species | Doses | Key findings | NOAEL/ LOAEL | Reference / KL rating; EFFECT=Unlabeled table on page 97: Study type, Species | Doses | Key findings | NOAEL/ LOAEL | Reference / KL rating; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"","duration":"","effect":"Unlabeled table on page 97: Study type, Species | Doses | Key findings | NOAEL/ LOAEL | Reference / KL rating","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"","noael_value":"unclear:Unlabeled table on page 97: Study type, Species | Doses | Key findings | NOAEL/ LOAEL | Reference / KL rating","page":97,"route":"","species":"","study_id":"sccs_o_291_noael_160"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 1000 mg/kg bw/day rat - - - SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=1000; DOSE=Unlabeled table on page 97: study in male F344 rats (50 /group) | equivalent to approximately 250, 500, 1000, 1500 and 2000 mg/kg bw/day | was observed in rats.; EFFECT=Unlabeled table on page 97: study in male F344 rats (50 /group) | equivalent to approximately 250, 500, 1000, 1500 and 2000 mg/kg bw/day | was observed in rats. At 1500 mg/kg bw/day and above, urinary bladder tumour formation was observed. | and systemic toxicity): 1000 mg/kg bw/day | 2015{Cal EPA, 2007 #4752)} /KL2; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"Unlabeled table on page 97: study in male F344 rats (50 /group) | equivalent to approximately 250, 500, 1000, 1500 and 2000 mg/kg bw/day | was observed in rats.","duration":"","effect":"Unlabeled table on page 97: study in male F344 rats (50 /group) | equivalent to approximately 250, 500, 1000, 1500 and 2000 mg/kg bw/day | was observed in rats. At 1500 mg/kg bw/day and above, urinary bladder tumour formation was observed. | and systemic toxicity): 1000 mg/kg bw/day | 2015{Cal EPA, 2007 #4752)} /KL2","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"1000","page":97,"route":"","species":"rat","study_id":"sccs_o_291_noael_161"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies carcinogenicity 250 mg/kg bw/day rat oral chronic carcinogenicity SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=250; DOSE=The NOAEL was established at 250 mg/kg bw/day.; EFFECT=nicity studies conducted with OPP and SOPP via the oral route identified the urinary bladder and kidneys as the main target tissues in mice and rats. A combined chronic toxicity/carcinogenicity study in B6C3F1 mice revealed that OPP induced tumours in liver and changes in kidney tubule morphology. The liver tumours observed in male mice were attributed to the high spontaneous occurrence of liver tumours in this specific mouse strain. The kidney changes included hypertrophy and increased relative kidney weight. The NOAEL was established at 250 mg/kg bw/day. In chronic toxicity/carcinogenicity in rats, kidney effects such as hyperplasia, cysts, infarct, acute inflammation, and papilla mineralisation of the kidney were observed. Further, neoplastic changes related to urinary bladder such as increased incidences of transitional cell carcinomas, papilloma, and increased incidence of calculi, congestion, haemorrhage mineralization and necrosis in the urinary bladder were observed. Based on the above effects, the NOAEL of 39 mg/kg bw/da; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"The NOAEL was established at 250 mg/kg bw/day.","duration":"chronic","effect":"nicity studies conducted with OPP and SOPP via the oral route identified the urinary bladder and kidneys as the main target tissues in mice and rats. A combined chronic toxicity/carcinogenicity study in B6C3F1 mice revealed that OPP induced tumours in liver and changes in kidney tubule morphology. The liver tumours observed in male mice were attributed to the high spontaneous occurrence of liver tumours in this specific mouse strain. The kidney changes included hypertrophy and increased relative kidney weight. The NOAEL was established at 250 mg/kg bw/day. In chronic toxicity/carcinogenicity in rats, kidney effects such as hyperplasia, cysts, infarct, acute inflammation, and papilla mineralisation of the kidney were observed. Further, neoplastic changes related to urinary bladder such as increased incidences of transitional cell carcinomas, papilloma, and increased incidence of calculi, congestion, haemorrhage mineralization and necrosis in the urinary bladder were observed. Based on the above effects, the NOAEL of 39 mg/kg bw/da","endpoint":"carcinogenicity","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"250","page":35,"route":"oral","species":"rat","study_id":"sccs_o_291_noael_005"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies carcinogenicity 39 mg/kg bw/day rat - chronic carcinogenicity SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=39; DOSE=The NOAEL was established at 250 mg/kg bw/day.; EFFECT=idney weight. The NOAEL was established at 250 mg/kg bw/day. In chronic toxicity/carcinogenicity in rats, kidney effects such as hyperplasia, cysts, infarct, acute inflammation, and papilla mineralisation of the kidney were observed. Further, neoplastic changes related to urinary bladder such as increased incidences of transitional cell carcinomas, papilloma, and increased incidence of calculi, congestion, haemorrhage mineralization and necrosis in the urinary bladder were observed. Based on the above effects, the NOAEL of 39 mg/kg bw/day was established. In another combined chronic and carcinogenicity study, rats exhibited an increased incidence of hepatocellular adenoma with extensive renal damage characterised by tubular dilation and varying degrees of acute and chronic inflammation at 1000 mg/kg bw/day. Furthermore, a 91-week study in male F344 rats associated OPP treatment with the development of urinary bladder tumours, such as papilloma and carcinoma, primarily transitional cell papilloma and carcinoma at and above 531 mg/; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"The NOAEL was established at 250 mg/kg bw/day.","duration":"chronic","effect":"idney weight. The NOAEL was established at 250 mg/kg bw/day. In chronic toxicity/carcinogenicity in rats, kidney effects such as hyperplasia, cysts, infarct, acute inflammation, and papilla mineralisation of the kidney were observed. Further, neoplastic changes related to urinary bladder such as increased incidences of transitional cell carcinomas, papilloma, and increased incidence of calculi, congestion, haemorrhage mineralization and necrosis in the urinary bladder were observed. Based on the above effects, the NOAEL of 39 mg/kg bw/day was established. In another combined chronic and carcinogenicity study, rats exhibited an increased incidence of hepatocellular adenoma with extensive renal damage characterised by tubular dilation and varying degrees of acute and chronic inflammation at 1000 mg/kg bw/day. Furthermore, a 91-week study in male F344 rats associated OPP treatment with the development of urinary bladder tumours, such as papilloma and carcinoma, primarily transitional cell papilloma and carcinoma at and above 531 mg/","endpoint":"carcinogenicity","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"39","page":35,"route":"","species":"rat","study_id":"sccs_o_291_noael_006"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies carcinogenicity 39 mg/kg bw/day rat - 91-week carcinogenicity SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=39; DOSE=Furthermore, a 91-week study in male F344 rats associated OPP treatment with the development of urinary bladder tumours, such as papilloma and carcinoma, primarily transitional cell papilloma and carcinoma at and above 531 mg/kg bw/day.; EFFECT=Furthermore, a 91-week study in male F344 rats associated OPP treatment with the development of urinary bladder tumours, such as papilloma and carcinoma, primarily transitional cell papilloma and carcinoma at and above 531 mg/kg bw/day. Overall, the available data for OPP suggests that a combination of factors is required to induce tumour formation in the bladder and kidneys of rats, indicating the presence of a threshold mode of action (MoA) for tumour development. In the above listed studies with OPP, the lowest NOAEL was established at 39 mg/kg bw/day, which can be considered as the threshold for carcinogenicity. The key factors contributing to the threshold MoA include the reversibility of effects, species and strain-specific differences, and tumor occurrence at high doses when sulphate and glucuronide conjugation pathways are saturated, and no skin tumor development induced by OPP metabolites. This threshold is further supported by the absence of genotoxicity in available studies with both OPP and SOPP. Additionally, factors; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"Furthermore, a 91-week study in male F344 rats associated OPP treatment with the development of urinary bladder tumours, such as papilloma and carcinoma, primarily transitional cell papilloma and carcinoma at and above 531 mg/kg bw/day.","duration":"91-week","effect":"Furthermore, a 91-week study in male F344 rats associated OPP treatment with the development of urinary bladder tumours, such as papilloma and carcinoma, primarily transitional cell papilloma and carcinoma at and above 531 mg/kg bw/day. Overall, the available data for OPP suggests that a combination of factors is required to induce tumour formation in the bladder and kidneys of rats, indicating the presence of a threshold mode of action (MoA) for tumour development. In the above listed studies with OPP, the lowest NOAEL was established at 39 mg/kg bw/day, which can be considered as the threshold for carcinogenicity. The key factors contributing to the threshold MoA include the reversibility of effects, species and strain-specific differences, and tumor occurrence at high doses when sulphate and glucuronide conjugation pathways are saturated, and no skin tumor development induced by OPP metabolites. This threshold is further supported by the absence of genotoxicity in available studies with both OPP and SOPP. Additionally, factors","endpoint":"carcinogenicity","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"39","page":35,"route":"","species":"rat","study_id":"sccs_o_291_noael_007"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies carcinogenicity 95 mg/kg bw/day rat dermal 2- year carcinogenicity SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=95; DOSE=The LOAEL for the first study was established at 224 mg/kg bw/day based on the increased incidence of focal atrophy of pancreas in females and the NOAEL was established at 95 mg/kg bw/day.; LOAEL_VALUE=224 mg/kg bw/day; EFFECT=a 2- year carcinogenicity study (conducted in 2 parts) in F344 rats, SOPP induced kidney tumours and increased incidences of interstitial nephritis of the kidney and increased incidences of focal atrophy of pancreatic acinar cells in females. Additionally, there was an increased incidence of urinary bladder tumours, including transitional cell papillomas and carcinomas. The LOAEL for the first study was established at 224 mg/kg bw/day based on the increased incidence of focal atrophy of pancreas in females and the NOAEL was established at 95 mg/kg bw/day. In a 112-week study in F344 male rats, transitional cell carcinoma was observed in rats at and above 1500 mg/kg bw/day. In a 102-week dermal carcinogenicity study in Swiss CD-1 mice, OPP did not induce skin neoplasms. In a 52-week, two-stage mouse skin carcinogenesis study in female CD-1 mice, SOPP induced epidermal proliferation and can act as a promoter but not as an initiator or a complete carcinogen. Overall, OPP and SOPP did not induce tumours when applied dermally. However; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"The LOAEL for the first study was established at 224 mg/kg bw/day based on the increased incidence of focal atrophy of pancreas in females and the NOAEL was established at 95 mg/kg bw/day.","duration":"2- year","effect":"a 2- year carcinogenicity study (conducted in 2 parts) in F344 rats, SOPP induced kidney tumours and increased incidences of interstitial nephritis of the kidney and increased incidences of focal atrophy of pancreatic acinar cells in females. Additionally, there was an increased incidence of urinary bladder tumours, including transitional cell papillomas and carcinomas. The LOAEL for the first study was established at 224 mg/kg bw/day based on the increased incidence of focal atrophy of pancreas in females and the NOAEL was established at 95 mg/kg bw/day. In a 112-week study in F344 male rats, transitional cell carcinoma was observed in rats at and above 1500 mg/kg bw/day. In a 102-week dermal carcinogenicity study in Swiss CD-1 mice, OPP did not induce skin neoplasms. In a 52-week, two-stage mouse skin carcinogenesis study in female CD-1 mice, SOPP induced epidermal proliferation and can act as a promoter but not as an initiator or a complete carcinogen. Overall, OPP and SOPP did not induce tumours when applied dermally. However","endpoint":"carcinogenicity","ingredient":"s, toys, textiles, clothing,","loael_value":"224 mg/kg bw/day","noael_unit":"mg/kg bw/day","noael_value":"95","page":35,"route":"dermal","species":"rat","study_id":"sccs_o_291_noael_008"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies carcinogenicity 49 mg/kg bw/day rat oral 13 weeks carcinogenicity SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=49; DOSE=ssation of 13 weeks of exposure to OPP) • Sex and species- and strain-specific differences (OPP-induced bladder tumours were not observed in female rats, mice, dogs) • dermal application to mice does not affect tumour incidence in skin • no skin tumour development induced by OPP metabolites • tumours occur at high doses when sulfate and glucuron...; LOAEL_VALUE=224 mg/kg bw/day; EFFECT=ssation of 13 weeks of exposure to OPP) • Sex and species- and strain-specific differences (OPP-induced bladder tumours were not observed in female rats, mice, dogs) • dermal application to mice does not affect tumour incidence in skin • no skin tumour development induced by OPP metabolites • tumours occur at high doses when sulfate and glucuronide conjugation pathways are saturated The SCCS has noted the NOAELs proposed by the Applicant for OPP and SOPP for systemic toxicity and carcinogenicity (for OPP: lowest NOAEL established at 39 and 49 mg/kg bw/day in males and females, respectively; for SOPP, an oral LOAEL of 224 mg/kg bw/day from a 104-week carcinogenicity study in rats has been considered as most appropriate and conservative value for PoD derivation. The Applicant applied a composite uncertainty factor of 10 to account for the extrapolation from LOAEL to NOAEL and study data quality resulting in a corrected PoD of 22.4 mg/kg bw/day. The SCCS, however, stated in SCCS/1555/15 that the 104-week carcinogenicity study in r; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"ssation of 13 weeks of exposure to OPP) • Sex and species- and strain-specific differences (OPP-induced bladder tumours were not observed in female rats, mice, dogs) • dermal application to mice does not affect tumour incidence in skin • no skin tumour development induced by OPP metabolites • tumours occur at high doses when sulfate and glucuron...","duration":"13 weeks","effect":"ssation of 13 weeks of exposure to OPP) • Sex and species- and strain-specific differences (OPP-induced bladder tumours were not observed in female rats, mice, dogs) • dermal application to mice does not affect tumour incidence in skin • no skin tumour development induced by OPP metabolites • tumours occur at high doses when sulfate and glucuronide conjugation pathways are saturated The SCCS has noted the NOAELs proposed by the Applicant for OPP and SOPP for systemic toxicity and carcinogenicity (for OPP: lowest NOAEL established at 39 and 49 mg/kg bw/day in males and females, respectively; for SOPP, an oral LOAEL of 224 mg/kg bw/day from a 104-week carcinogenicity study in rats has been considered as most appropriate and conservative value for PoD derivation. The Applicant applied a composite uncertainty factor of 10 to account for the extrapolation from LOAEL to NOAEL and study data quality resulting in a corrected PoD of 22.4 mg/kg bw/day. The SCCS, however, stated in SCCS/1555/15 that the 104-week carcinogenicity study in r","endpoint":"carcinogenicity","ingredient":"s, toys, textiles, clothing,","loael_value":"224 mg/kg bw/day","noael_unit":"mg/kg bw/day","noael_value":"49","page":37,"route":"oral","species":"rat","study_id":"sccs_o_291_noael_009"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies carcinogenicity 1000 mg/kg bw/day mouse oral Chronic carcinogenicity SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=1000; DOSE=OECD TG 453 0, 250, 500 and 1000 mg/kg bw/day At 1000 and 500 mg/kg bw/day, ↓ body weight, ↑ relative liver weights, absolute and relative brain weight, relative testes weights and reduced absolute weights of heart, kidneys, and spleen; ↑ incidences of adenoma, increase in hepatocellular adenoma were observed.; EFFECT=SCCS/1669/24 Final version Opinion on the safety of Biphenyl-2-ol and Sodium 2-biphenylolate (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 93 9.7 ANNEX 7. Carcinogenicity Chronic toxicity and carcinogenicity studies Study type, Species Doses Key findings NOAEL/ LOAEL Reference / KL rating OPP Oral 2-year combined chronic toxicity/ carcinogenicity study in B6C3F1 mice (50/sex/group); OECD TG 453 0, 250, 500 and 1000 mg/kg bw/day At 1000 and 500 mg/kg bw/day, ↓ body weight, ↑ relative liver weights, absolute and relative brain weight, relative testes weights and reduced absolute weights of heart, kidneys, and spleen; ↑ incidences of adenoma, increase in hepatocellular adenoma were observed. At all doses, kidney hypertrophy and ↑ relative kidney weights were observed in fe; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"OECD TG 453 0, 250, 500 and 1000 mg/kg bw/day At 1000 and 500 mg/kg bw/day, ↓ body weight, ↑ relative liver weights, absolute and relative brain weight, relative testes weights and reduced absolute weights of heart, kidneys, and spleen; ↑ incidences of adenoma, increase in hepatocellular adenoma were observed.","duration":"Chronic","effect":"SCCS/1669/24 Final version Opinion on the safety of Biphenyl-2-ol and Sodium 2-biphenylolate (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 93 9.7 ANNEX 7. Carcinogenicity Chronic toxicity and carcinogenicity studies Study type, Species Doses Key findings NOAEL/ LOAEL Reference / KL rating OPP Oral 2-year combined chronic toxicity/ carcinogenicity study in B6C3F1 mice (50/sex/group); OECD TG 453 0, 250, 500 and 1000 mg/kg bw/day At 1000 and 500 mg/kg bw/day, ↓ body weight, ↑ relative liver weights, absolute and relative brain weight, relative testes weights and reduced absolute weights of heart, kidneys, and spleen; ↑ incidences of adenoma, increase in hepatocellular adenoma were observed. At all doses, kidney hypertrophy and ↑ relative kidney weights were observed in fe","endpoint":"carcinogenicity","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"1000","page":93,"route":"oral","species":"mouse","study_id":"sccs_o_291_noael_065"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies carcinogenicity 250 mg/kg bw/day rat oral 2-year carcinogenicity SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=250; DOSE=OECD TG 453 0, 250, 500 and 1000 mg/kg bw/day At 1000 and 500 mg/kg bw/day, ↓ body weight, ↑ relative liver weights, absolute and relative brain weight, relative testes weights and reduced absolute weights of heart, kidneys, and spleen; ↑ incidences of adenoma, increase in hepatocellular adenoma were observed.; LOAEL_VALUE=250 mg/kg bw/day; EFFECT=Reference / KL rating OPP Oral 2-year combined chronic toxicity/ carcinogenicity study in B6C3F1 mice (50/sex/group); OECD TG 453 0, 250, 500 and 1000 mg/kg bw/day At 1000 and 500 mg/kg bw/day, ↓ body weight, ↑ relative liver weights, absolute and relative brain weight, relative testes weights and reduced absolute weights of heart, kidneys, and spleen; ↑ incidences of adenoma, increase in hepatocellular adenoma were observed. At all doses, kidney hypertrophy and ↑ relative kidney weights were observed in females. NOAEL (carcinogenicity): 250 mg/kg bw/day LOAEL (systemic toxicity): 250 mg/kg bw/day Quast J.F. and McGuirk R.J. 1995 in (Cal EPA, 2007; EC, 2023; ECHA, 2023b; SCCS, 2015)/KL1 91-week dietary study in F344/DuCrj rats (20-24 male/group), no guideline 0, 0.625, 1.25 and 2.5%, equivalent to 269, 531 and 1140 mg/kg bw/day At 1140 mg/kg bw/day, ↑white blood cell count, haematuria, ↓body weights, proliferative lesions in the urinary bladder, and moderate to severe nephritic lesions and urinary bladder tumours (papilloma and; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"OECD TG 453 0, 250, 500 and 1000 mg/kg bw/day At 1000 and 500 mg/kg bw/day, ↓ body weight, ↑ relative liver weights, absolute and relative brain weight, relative testes weights and reduced absolute weights of heart, kidneys, and spleen; ↑ incidences of adenoma, increase in hepatocellular adenoma were observed.","duration":"2-year","effect":"Reference / KL rating OPP Oral 2-year combined chronic toxicity/ carcinogenicity study in B6C3F1 mice (50/sex/group); OECD TG 453 0, 250, 500 and 1000 mg/kg bw/day At 1000 and 500 mg/kg bw/day, ↓ body weight, ↑ relative liver weights, absolute and relative brain weight, relative testes weights and reduced absolute weights of heart, kidneys, and spleen; ↑ incidences of adenoma, increase in hepatocellular adenoma were observed. At all doses, kidney hypertrophy and ↑ relative kidney weights were observed in females. NOAEL (carcinogenicity): 250 mg/kg bw/day LOAEL (systemic toxicity): 250 mg/kg bw/day Quast J.F. and McGuirk R.J. 1995 in (Cal EPA, 2007; EC, 2023; ECHA, 2023b; SCCS, 2015)/KL1 91-week dietary study in F344/DuCrj rats (20-24 male/group), no guideline 0, 0.625, 1.25 and 2.5%, equivalent to 269, 531 and 1140 mg/kg bw/day At 1140 mg/kg bw/day, ↑white blood cell count, haematuria, ↓body weights, proliferative lesions in the urinary bladder, and moderate to severe nephritic lesions and urinary bladder tumours (papilloma and","endpoint":"carcinogenicity","ingredient":"s, toys, textiles, clothing,","loael_value":"250 mg/kg bw/day","noael_unit":"mg/kg bw/day","noael_value":"250","page":93,"route":"oral","species":"rat","study_id":"sccs_o_291_noael_066"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies carcinogenicity 269 mg/kg bw/day rat - 2-year carcinogenicity SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=269; DOSE=At 531 mg/kg bw/day, haematuria, ↓body weights, proliferative lesions in the urinary bladder, and moderate to severe nephritic lesions and urinary bladder tumours (papilloma and carcinoma, mainly transitional cell papilloma and carcinoma) were observed.; EFFECT=/day, ↑white blood cell count, haematuria, ↓body weights, proliferative lesions in the urinary bladder, and moderate to severe nephritic lesions and urinary bladder tumours (papilloma and carcinoma, mainly transitional cell papilloma and carcinoma). were observed. At 531 mg/kg bw/day, haematuria, ↓body weights, proliferative lesions in the urinary bladder, and moderate to severe nephritic lesions and urinary bladder tumours (papilloma and carcinoma, mainly transitional cell papilloma and carcinoma) were observed. NOAEL (carcinogenicity): 269 mg/kg bw/day Hiraga K., and Fujii T. 1984 in (EC, 2023; ECHA, 2023b; ECHA RAC, 2022; SCCS, 2015)/KL2 2-year combined chronic toxicity/ carcinogenicity study in CDF[F344]/BR rats 0, 800, 4000 and 8000/ 10000 ppm (equivalent to 0, 39/49, 200/248 and 402/647 mg/kg bw/day in At 402/647 mg/kg bw/day, ↑ incidence of urinary bladder masses, ↑ incidence of pitted zones in kidneys. Neoplastic changes such as ↑ incidence of transitional NOAEL (carcinogenicity and systemic toxicity): 39 and 49 mg/kg bw; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"At 531 mg/kg bw/day, haematuria, ↓body weights, proliferative lesions in the urinary bladder, and moderate to severe nephritic lesions and urinary bladder tumours (papilloma and carcinoma, mainly transitional cell papilloma and carcinoma) were observed.","duration":"2-year","effect":"/day, ↑white blood cell count, haematuria, ↓body weights, proliferative lesions in the urinary bladder, and moderate to severe nephritic lesions and urinary bladder tumours (papilloma and carcinoma, mainly transitional cell papilloma and carcinoma). were observed. At 531 mg/kg bw/day, haematuria, ↓body weights, proliferative lesions in the urinary bladder, and moderate to severe nephritic lesions and urinary bladder tumours (papilloma and carcinoma, mainly transitional cell papilloma and carcinoma) were observed. NOAEL (carcinogenicity): 269 mg/kg bw/day Hiraga K., and Fujii T. 1984 in (EC, 2023; ECHA, 2023b; ECHA RAC, 2022; SCCS, 2015)/KL2 2-year combined chronic toxicity/ carcinogenicity study in CDF[F344]/BR rats 0, 800, 4000 and 8000/ 10000 ppm (equivalent to 0, 39/49, 200/248 and 402/647 mg/kg bw/day in At 402/647 mg/kg bw/day, ↑ incidence of urinary bladder masses, ↑ incidence of pitted zones in kidneys. Neoplastic changes such as ↑ incidence of transitional NOAEL (carcinogenicity and systemic toxicity): 39 and 49 mg/kg bw","endpoint":"carcinogenicity","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"269","page":93,"route":"","species":"rat","study_id":"sccs_o_291_noael_067"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies carcinogenicity 49 mg/kg bw/day rat - 2-year carcinogenicity SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=49; DOSE=269 mg/kg bw/day Hiraga K., and Fujii T.; EFFECT=transitional cell papilloma and carcinoma) were observed. NOAEL (carcinogenicity): 269 mg/kg bw/day Hiraga K., and Fujii T. 1984 in (EC, 2023; ECHA, 2023b; ECHA RAC, 2022; SCCS, 2015)/KL2 2-year combined chronic toxicity/ carcinogenicity study in CDF[F344]/BR rats 0, 800, 4000 and 8000/ 10000 ppm (equivalent to 0, 39/49, 200/248 and 402/647 mg/kg bw/day in At 402/647 mg/kg bw/day, ↑ incidence of urinary bladder masses, ↑ incidence of pitted zones in kidneys. Neoplastic changes such as ↑ incidence of transitional NOAEL (carcinogenicity and systemic toxicity): 39 and 49 mg/kg bw/day in males Wahle et al...,1996 in (ECHA, 2023b; ECHA RAC, 2022;; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"269 mg/kg bw/day Hiraga K., and Fujii T.","duration":"2-year","effect":"transitional cell papilloma and carcinoma) were observed. NOAEL (carcinogenicity): 269 mg/kg bw/day Hiraga K., and Fujii T. 1984 in (EC, 2023; ECHA, 2023b; ECHA RAC, 2022; SCCS, 2015)/KL2 2-year combined chronic toxicity/ carcinogenicity study in CDF[F344]/BR rats 0, 800, 4000 and 8000/ 10000 ppm (equivalent to 0, 39/49, 200/248 and 402/647 mg/kg bw/day in At 402/647 mg/kg bw/day, ↑ incidence of urinary bladder masses, ↑ incidence of pitted zones in kidneys. Neoplastic changes such as ↑ incidence of transitional NOAEL (carcinogenicity and systemic toxicity): 39 and 49 mg/kg bw/day in males Wahle et al...,1996 in (ECHA, 2023b; ECHA RAC, 2022;","endpoint":"carcinogenicity","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"49","page":93,"route":"","species":"rat","study_id":"sccs_o_291_noael_068"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies carcinogenicity 100 mg/kg bw/day rat dermal 2-year carcinogenicity SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=100; DOSE=Similar to OECD TG 453 0, 0.02, 0.2 and 2% equivalent to 0, 10, 100 and 1000 mg/kg bw/day At 1000 mg/kg bw/day, ↓ body weight, ↑weight of testes and histopathological changes such as extensive renal damage, characterised by tubular dilation with varying degrees of acute and chronic inflammation was observed.; EFFECT=inical signs and gross pathological signs of toxicity. and females, respectively SCCS, 2015; US EPA, 2013)/KL1 2-year combined chronic toxicity/ carcinogenicity study in weanling Rochester rats (25/sex/group); Similar to OECD TG 453 0, 0.02, 0.2 and 2% equivalent to 0, 10, 100 and 1000 mg/kg bw/day At 1000 mg/kg bw/day, ↓ body weight, ↑weight of testes and histopathological changes such as extensive renal damage, characterised by tubular dilation with varying degrees of acute and chronic inflammation was observed. NOAEL: 100 mg/kg bw/day Hodge HC., et al... 1952 in (EC, 2023)/KL2 Dermal 2-year dermal carcinogenicity study in Swiss CD-1 mice (50/sex/group); no guideline 0.1 mL OPP (55.5 mg/0.1 mL acetone) 3 days/week; promotion test No skin neoplasms occurred however, non-neoplastic lesions (ulcer, active chronic inflammation, hyperkeratosis, and acanthosis) were observed at the application site. After tumour initiation with DMBA (7,12- dimethylbenz[a]anthracene), OPP didn’t show a promoting effect. Systemically, slightly increase; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"Similar to OECD TG 453 0, 0.02, 0.2 and 2% equivalent to 0, 10, 100 and 1000 mg/kg bw/day At 1000 mg/kg bw/day, ↓ body weight, ↑weight of testes and histopathological changes such as extensive renal damage, characterised by tubular dilation with varying degrees of acute and chronic inflammation was observed.","duration":"2-year","effect":"inical signs and gross pathological signs of toxicity. and females, respectively SCCS, 2015; US EPA, 2013)/KL1 2-year combined chronic toxicity/ carcinogenicity study in weanling Rochester rats (25/sex/group); Similar to OECD TG 453 0, 0.02, 0.2 and 2% equivalent to 0, 10, 100 and 1000 mg/kg bw/day At 1000 mg/kg bw/day, ↓ body weight, ↑weight of testes and histopathological changes such as extensive renal damage, characterised by tubular dilation with varying degrees of acute and chronic inflammation was observed. NOAEL: 100 mg/kg bw/day Hodge HC., et al... 1952 in (EC, 2023)/KL2 Dermal 2-year dermal carcinogenicity study in Swiss CD-1 mice (50/sex/group); no guideline 0.1 mL OPP (55.5 mg/0.1 mL acetone) 3 days/week; promotion test No skin neoplasms occurred however, non-neoplastic lesions (ulcer, active chronic inflammation, hyperkeratosis, and acanthosis) were observed at the application site. After tumour initiation with DMBA (7,12- dimethylbenz[a]anthracene), OPP didn’t show a promoting effect. Systemically, slightly increase","endpoint":"carcinogenicity","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"100","page":94,"route":"dermal","species":"rat","study_id":"sccs_o_291_noael_070"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies carcinogenicity 125 mg/kg bw/day - oral 2-year carcinogenicity SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=125; DOSE=no guideline 0, 0.125, 0.25, 0.5, 1.0, 2.0 and 4.0% equivalent to 0, 62, 125, 250, 500, 1000 and 2000 mg/kg bw/dayk At 2000 mg/kg bw/day, ↑incidence of carcinoma in the renal papilla was observed.; LOAEL_VALUE=62 mg/kg bw/day; EFFECT=no guideline 0, 0.125, 0.25, 0.5, 1.0, 2.0 and 4.0% equivalent to 0, 62, 125, 250, 500, 1000 and 2000 mg/kg bw/dayk At 2000 mg/kg bw/day, ↑incidence of carcinoma in the renal papilla was observed. At 1000 mg/kg bw/day, ↑ in the incidence of tumours of the urinary system and carcinosarcoma was observed. At 500 mg/kg bw/day, ↑in the incidence of tumours of the urinary system was observed. At 250 mg/kg bw/day, ↑in the incidence of tumours of the urinary system was observed. Haematuria was observed at all dose levels. NOAEL (carcinogenicity): 125 mg/kg bw/day LOAEL (systemic toxicity): 62 mg/kg bw/day Hiraga et al..., 1981 in (SCCS, 2015)/KL2 2-year dietary carcinogenicity 1st study: Males: 0, 7000 and 20000 ppm, At 466/770 mg/kg bw/day, ↑ focal atrophy of the LOAEL (carcinogenicity Hiraga et al..., 1983 in (SCCS,; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"no guideline 0, 0.125, 0.25, 0.5, 1.0, 2.0 and 4.0% equivalent to 0, 62, 125, 250, 500, 1000 and 2000 mg/kg bw/dayk At 2000 mg/kg bw/day, ↑incidence of carcinoma in the renal papilla was observed.","duration":"2-year","effect":"no guideline 0, 0.125, 0.25, 0.5, 1.0, 2.0 and 4.0% equivalent to 0, 62, 125, 250, 500, 1000 and 2000 mg/kg bw/dayk At 2000 mg/kg bw/day, ↑incidence of carcinoma in the renal papilla was observed. At 1000 mg/kg bw/day, ↑ in the incidence of tumours of the urinary system and carcinosarcoma was observed. At 500 mg/kg bw/day, ↑in the incidence of tumours of the urinary system was observed. At 250 mg/kg bw/day, ↑in the incidence of tumours of the urinary system was observed. Haematuria was observed at all dose levels. NOAEL (carcinogenicity): 125 mg/kg bw/day LOAEL (systemic toxicity): 62 mg/kg bw/day Hiraga et al..., 1981 in (SCCS, 2015)/KL2 2-year dietary carcinogenicity 1st study: Males: 0, 7000 and 20000 ppm, At 466/770 mg/kg bw/day, ↑ focal atrophy of the LOAEL (carcinogenicity Hiraga et al..., 1983 in (SCCS,","endpoint":"carcinogenicity","ingredient":"s, toys, textiles, clothing,","loael_value":"62 mg/kg bw/day","noael_unit":"mg/kg bw/day","noael_value":"125","page":95,"route":"oral","species":"","study_id":"sccs_o_291_noael_073"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies carcinogenicity 95 mg/kg bw/day rat - 56-week carcinogenicity SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=95; DOSE=nd study 0, 2500, 7000 and 20000 ppm equivalent to 0, 95, 270 and 770 mg/kg bw/day in males;; EFFECT=nd study 0, 2500, 7000 and 20000 ppm equivalent to 0, 95, 270 and 770 mg/kg bw/day in males; 0, 2500, 5000 and 10000 ppm equivalent to 0, 113, 224 and 466 mg/kg bw/day in females with a 56-week recovery period At 466/770 mg/kg bw/day, kidney, bladder lesions and↑ incidences of interstitial nephritis of the kidney in females, ↓ body weights and haematuria were observed in males. At 224/270 mg/kg bw/day, ↑ incidences of interstitial nephritis of the kidney, urinary bladder papillomas and/or carcinomas were observed. NOAEL (carcinogenicity and systemic toxicity): 95 mg/kg bw/day 2-year carcinogenicity study in male F344 rats (groups not specified); no guideline 0, 0.25, 0.5, 1.0 and 2.0% equivalent to approximately 0, 197, 395, 780 and 1579 mg/kg bw/dayl At 1579 mg/kg bw/day, hyperplasia of bladder was observed. Development of papilloma and carcinoma was observed after 36 weeks. At 780 mg/kg bw/day, development of simple hyperplasia from week 36 was observed. NOAEL (carcinogenicity and systemic toxicity): 395 mg/kg bw/day Fukushima; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"nd study 0, 2500, 7000 and 20000 ppm equivalent to 0, 95, 270 and 770 mg/kg bw/day in males;","duration":"56-week","effect":"nd study 0, 2500, 7000 and 20000 ppm equivalent to 0, 95, 270 and 770 mg/kg bw/day in males; 0, 2500, 5000 and 10000 ppm equivalent to 0, 113, 224 and 466 mg/kg bw/day in females with a 56-week recovery period At 466/770 mg/kg bw/day, kidney, bladder lesions and↑ incidences of interstitial nephritis of the kidney in females, ↓ body weights and haematuria were observed in males. At 224/270 mg/kg bw/day, ↑ incidences of interstitial nephritis of the kidney, urinary bladder papillomas and/or carcinomas were observed. NOAEL (carcinogenicity and systemic toxicity): 95 mg/kg bw/day 2-year carcinogenicity study in male F344 rats (groups not specified); no guideline 0, 0.25, 0.5, 1.0 and 2.0% equivalent to approximately 0, 197, 395, 780 and 1579 mg/kg bw/dayl At 1579 mg/kg bw/day, hyperplasia of bladder was observed. Development of papilloma and carcinoma was observed after 36 weeks. At 780 mg/kg bw/day, development of simple hyperplasia from week 36 was observed. NOAEL (carcinogenicity and systemic toxicity): 395 mg/kg bw/day Fukushima","endpoint":"carcinogenicity","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"95","page":96,"route":"","species":"rat","study_id":"sccs_o_291_noael_075"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies carcinogenicity 395 mg/kg bw/day rat - 2-year carcinogenicity SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=395; DOSE=95 mg/kg bw/day 2-year carcinogenicity study in male F344 rats (groups not specified); no guideline 0, 0.25, 0.5, 1.0 and 2.0% equivalent to approximately 0, 197, 395, 780 and 1579 mg/kg bw/dayl At 1579 mg/kg bw/day, hyperplasia of bladder was observed.; EFFECT=kidney, urinary bladder papillomas and/or carcinomas were observed. NOAEL (carcinogenicity and systemic toxicity): 95 mg/kg bw/day 2-year carcinogenicity study in male F344 rats (groups not specified); no guideline 0, 0.25, 0.5, 1.0 and 2.0% equivalent to approximately 0, 197, 395, 780 and 1579 mg/kg bw/dayl At 1579 mg/kg bw/day, hyperplasia of bladder was observed. Development of papilloma and carcinoma was observed after 36 weeks. At 780 mg/kg bw/day, development of simple hyperplasia from week 36 was observed. NOAEL (carcinogenicity and systemic toxicity): 395 mg/kg bw/day Fukushima et al..., 1982 in (SCCS, 2015)/KL4 112-week carcinogenicity 0, 2500, 5000, 10000, 15000 and 20000 ppm At 1500 mg/kg bw/day, transitional cell carcinoma NOAEL (carcinogenicity Niho et al..., 2002 in (SCCS,; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"95 mg/kg bw/day 2-year carcinogenicity study in male F344 rats (groups not specified); no guideline 0, 0.25, 0.5, 1.0 and 2.0% equivalent to approximately 0, 197, 395, 780 and 1579 mg/kg bw/dayl At 1579 mg/kg bw/day, hyperplasia of bladder was observed.","duration":"2-year","effect":"kidney, urinary bladder papillomas and/or carcinomas were observed. NOAEL (carcinogenicity and systemic toxicity): 95 mg/kg bw/day 2-year carcinogenicity study in male F344 rats (groups not specified); no guideline 0, 0.25, 0.5, 1.0 and 2.0% equivalent to approximately 0, 197, 395, 780 and 1579 mg/kg bw/dayl At 1579 mg/kg bw/day, hyperplasia of bladder was observed. Development of papilloma and carcinoma was observed after 36 weeks. At 780 mg/kg bw/day, development of simple hyperplasia from week 36 was observed. NOAEL (carcinogenicity and systemic toxicity): 395 mg/kg bw/day Fukushima et al..., 1982 in (SCCS, 2015)/KL4 112-week carcinogenicity 0, 2500, 5000, 10000, 15000 and 20000 ppm At 1500 mg/kg bw/day, transitional cell carcinoma NOAEL (carcinogenicity Niho et al..., 2002 in (SCCS,","endpoint":"carcinogenicity","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"395","page":96,"route":"","species":"rat","study_id":"sccs_o_291_noael_076"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies carcinogenicity 1500 mg/kg bw/day - - 36 weeks carcinogenicity SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=1500; DOSE=.5, 1.0 and 2.0% equivalent to approximately 0, 197, 395, 780 and 1579 mg/kg bw/dayl At 1579 mg/kg bw/day, hyperplasia of bladder was observed.; EFFECT=.5, 1.0 and 2.0% equivalent to approximately 0, 197, 395, 780 and 1579 mg/kg bw/dayl At 1579 mg/kg bw/day, hyperplasia of bladder was observed. Development of papilloma and carcinoma was observed after 36 weeks. At 780 mg/kg bw/day, development of simple hyperplasia from week 36 was observed. NOAEL (carcinogenicity and systemic toxicity): 395 mg/kg bw/day Fukushima et al..., 1982 in (SCCS, 2015)/KL4 112-week carcinogenicity 0, 2500, 5000, 10000, 15000 and 20000 ppm At 1500 mg/kg bw/day, transitional cell carcinoma NOAEL (carcinogenicity Niho et al..., 2002 in (SCCS,; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":".5, 1.0 and 2.0% equivalent to approximately 0, 197, 395, 780 and 1579 mg/kg bw/dayl At 1579 mg/kg bw/day, hyperplasia of bladder was observed.","duration":"36 weeks","effect":".5, 1.0 and 2.0% equivalent to approximately 0, 197, 395, 780 and 1579 mg/kg bw/dayl At 1579 mg/kg bw/day, hyperplasia of bladder was observed. Development of papilloma and carcinoma was observed after 36 weeks. At 780 mg/kg bw/day, development of simple hyperplasia from week 36 was observed. NOAEL (carcinogenicity and systemic toxicity): 395 mg/kg bw/day Fukushima et al..., 1982 in (SCCS, 2015)/KL4 112-week carcinogenicity 0, 2500, 5000, 10000, 15000 and 20000 ppm At 1500 mg/kg bw/day, transitional cell carcinoma NOAEL (carcinogenicity Niho et al..., 2002 in (SCCS,","endpoint":"carcinogenicity","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"1500","page":96,"route":"","species":"","study_id":"sccs_o_291_noael_077"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies carcinogenicity 250 mg/kg bw/day rat - - carcinogenicity SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=250; DOSE=At 1000 and 500 mg/kg bw/day, increased incidences of hepatocellular adenoma were observed in males.; LOAEL_VALUE=250 mg/kg bw/day; EFFECT=in heart, kidney weights, relative brain and testes weights were observed. At 1000 and 500 mg/kg bw/day, increased incidences of hepatocellular adenoma were observed in males. In female mice, microscopic changes in liver were seen; however, no hepatoblastoma and significant increases in liver or other tumours was observed. At all doses, kidney hypertrophy and increased relative kidney weights were observed in females. Conclusion Under the study conditions, OPP was considered to be carcinogenic in B6C3F1 mice. The NOAEL for carcinogenicity was established at 250 mg/kg bw/day, whereas LOAEL for systemic toxicity was established at 250 mg/kg bw/day. Note: Cal EPA (2007) considered the incidence of hepatoblastoma at the 500 mg/kg bw/day dose as treatment-related due to its rare spontaneous occurrence in this strain. Details on the study by Wahle et al..., 1996 as presented by the Applicant: Guideline: OECD TG 453 Species/strain: Rat/ CDF[F-344]/BR Group size: a) one year sacrifice group: 20/sex in control and high dose group, 10/se; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"At 1000 and 500 mg/kg bw/day, increased incidences of hepatocellular adenoma were observed in males.","duration":"","effect":"in heart, kidney weights, relative brain and testes weights were observed. At 1000 and 500 mg/kg bw/day, increased incidences of hepatocellular adenoma were observed in males. In female mice, microscopic changes in liver were seen; however, no hepatoblastoma and significant increases in liver or other tumours was observed. At all doses, kidney hypertrophy and increased relative kidney weights were observed in females. Conclusion Under the study conditions, OPP was considered to be carcinogenic in B6C3F1 mice. The NOAEL for carcinogenicity was established at 250 mg/kg bw/day, whereas LOAEL for systemic toxicity was established at 250 mg/kg bw/day. Note: Cal EPA (2007) considered the incidence of hepatoblastoma at the 500 mg/kg bw/day dose as treatment-related due to its rare spontaneous occurrence in this strain. Details on the study by Wahle et al..., 1996 as presented by the Applicant: Guideline: OECD TG 453 Species/strain: Rat/ CDF[F-344]/BR Group size: a) one year sacrifice group: 20/sex in control and high dose group, 10/se","endpoint":"carcinogenicity","ingredient":"s, toys, textiles, clothing,","loael_value":"250 mg/kg bw/day","noael_unit":"mg/kg bw/day","noael_value":"250","page":98,"route":"","species":"rat","study_id":"sccs_o_291_noael_079"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies carcinogenicity 49 mg/kg bw/day rat - - carcinogenicity SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=49; DOSE=The NOAEL for systemic toxicity and carcinogenicity was established at 39 and 49 mg/kg bw/day in males and females, respectively.; EFFECT=ogical signs of toxicity and increases in the incidence of retinal degeneration and optic nerve atrophy were observed. Changes in clinical chemistry such as increased chlorine levels, a decrease in uric acid, triglycerides, cholesterol, and total bilirubin levels were observed. Neoplastic changes such as increased incidence of transitional cell carcinomas in males of simple urinary bladder hyperplasia were observed. Conclusion Under the study conditions, OPP was assessed to be carcinogenic in Fischer 344 rats. The NOAEL for systemic toxicity and carcinogenicity was established at 39 and 49 mg/kg bw/day in males and females, respectively. Details on the study on SOPP by Hiraga et al..., 1983 as presented by the Applicant Guideline: No guideline specified Species/strain: Rat/F344 rats; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"The NOAEL for systemic toxicity and carcinogenicity was established at 39 and 49 mg/kg bw/day in males and females, respectively.","duration":"","effect":"ogical signs of toxicity and increases in the incidence of retinal degeneration and optic nerve atrophy were observed. Changes in clinical chemistry such as increased chlorine levels, a decrease in uric acid, triglycerides, cholesterol, and total bilirubin levels were observed. Neoplastic changes such as increased incidence of transitional cell carcinomas in males of simple urinary bladder hyperplasia were observed. Conclusion Under the study conditions, OPP was assessed to be carcinogenic in Fischer 344 rats. The NOAEL for systemic toxicity and carcinogenicity was established at 39 and 49 mg/kg bw/day in males and females, respectively. Details on the study on SOPP by Hiraga et al..., 1983 as presented by the Applicant Guideline: No guideline specified Species/strain: Rat/F344 rats","endpoint":"carcinogenicity","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"49","page":99,"route":"","species":"rat","study_id":"sccs_o_291_noael_080"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies carcinogenicity 224 mg/kg bw/day rat - - carcinogenicity SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=224; DOSE=In the first study, the LOAEL for systemic toxicity and carcinogenicity was established at 270 and 224 mg/kg bw/day in males and females, respectively.; LOAEL_VALUE=224 mg/kg bw/day; EFFECT=isher Exact test, as calculated by DPR in Cal EPA, 2007: significant at p<0.05, p<0.01, p<0.001, respectively. +,++,+++ Cochran-Armitage trend test, as calculated by DPR in Cal EPA, 2007; significant at p<0.05, p<0.01, and p<0.001, respectively. Conclusion Under the study conditions, SOPP was assessed to be carcinogenic in Fischer 344 rats. In the first study, the LOAEL for systemic toxicity and carcinogenicity was established at 270 and 224 mg/kg bw/day in males and females, respectively. In the second study, the NOAEL for both systemic toxicity and carcinogenicity was established at 95 and 113 mg/kg bw/day in males and females, respectively. Note: The non-neoplastic changes such as interstitial nephritis and pyelonephritis and neoplastic changes such as transitional cell papilloma and carcinoma in the kidneys and carcinomas/papilloma induced in the bladder at 224/270 mg/kg bw/day did not reach statistical significance. However, in their evaluation, Cal EPA (2007) considered the observations to be treatment-related findings beca; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"In the first study, the LOAEL for systemic toxicity and carcinogenicity was established at 270 and 224 mg/kg bw/day in males and females, respectively.","duration":"","effect":"isher Exact test, as calculated by DPR in Cal EPA, 2007: significant at p<0.05, p<0.01, p<0.001, respectively. +,++,+++ Cochran-Armitage trend test, as calculated by DPR in Cal EPA, 2007; significant at p<0.05, p<0.01, and p<0.001, respectively. Conclusion Under the study conditions, SOPP was assessed to be carcinogenic in Fischer 344 rats. In the first study, the LOAEL for systemic toxicity and carcinogenicity was established at 270 and 224 mg/kg bw/day in males and females, respectively. In the second study, the NOAEL for both systemic toxicity and carcinogenicity was established at 95 and 113 mg/kg bw/day in males and females, respectively. Note: The non-neoplastic changes such as interstitial nephritis and pyelonephritis and neoplastic changes such as transitional cell papilloma and carcinoma in the kidneys and carcinomas/papilloma induced in the bladder at 224/270 mg/kg bw/day did not reach statistical significance. However, in their evaluation, Cal EPA (2007) considered the observations to be treatment-related findings beca","endpoint":"carcinogenicity","ingredient":"s, toys, textiles, clothing,","loael_value":"224 mg/kg bw/day","noael_unit":"mg/kg bw/day","noael_value":"224","page":102,"route":"","species":"rat","study_id":"sccs_o_291_noael_081"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies carcinogenicity 1000 mg/kg bw/day mouse - 2-year carcinogenicity SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=1000; DOSE=OECD TG 453 | 0, 250, 500 and 1000 mg/kg bw/day | At 1000 and 500 mg/kg bw/day, ↓ body weight, ↑ relative liver weights, absolute and relative brain weight, relative testes weights and reduced absolute weights of heart, kidneys, and spleen; ↑ incidences of adenoma, increase in hepatocellular adenoma were observed.; LOAEL_VALUE=250 mg/kg bw/day; EFFECT=Unlabeled table on page 93: 2-year combined chronic toxicity/ carcinogenicity study in B6C3F1 mice (50/sex/group); OECD TG 453 | 0, 250, 500 and 1000 mg/kg bw/day | At 1000 and 500 mg/kg bw/day, ↓ body weight, ↑ relative liver weights, absolute and relative brain weight, relative testes weights and reduced absolute weights of heart, kidneys, and spleen; ↑ incidences of adenoma, increase in hepatocellular adenoma were observed. At all doses, kidney hypertrophy and ↑ relative kidney weights were observed in females. | NOAEL (carcinogenicity): 250 mg/kg bw/day LOAEL (systemic toxicity): 250 mg/kg bw/day | Quast J.F. and McGuirk R.J. 1995 in (Cal EPA, 2007; EC, 2023; ECHA, 2023b; SCCS, 2015)/KL1; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"OECD TG 453 | 0, 250, 500 and 1000 mg/kg bw/day | At 1000 and 500 mg/kg bw/day, ↓ body weight, ↑ relative liver weights, absolute and relative brain weight, relative testes weights and reduced absolute weights of heart, kidneys, and spleen; ↑ incidences of adenoma, increase in hepatocellular adenoma were observed.","duration":"2-year","effect":"Unlabeled table on page 93: 2-year combined chronic toxicity/ carcinogenicity study in B6C3F1 mice (50/sex/group); OECD TG 453 | 0, 250, 500 and 1000 mg/kg bw/day | At 1000 and 500 mg/kg bw/day, ↓ body weight, ↑ relative liver weights, absolute and relative brain weight, relative testes weights and reduced absolute weights of heart, kidneys, and spleen; ↑ incidences of adenoma, increase in hepatocellular adenoma were observed. At all doses, kidney hypertrophy and ↑ relative kidney weights were observed in females. | NOAEL (carcinogenicity): 250 mg/kg bw/day LOAEL (systemic toxicity): 250 mg/kg bw/day | Quast J.F. and McGuirk R.J. 1995 in (Cal EPA, 2007; EC, 2023; ECHA, 2023b; SCCS, 2015)/KL1","endpoint":"carcinogenicity","ingredient":"s, toys, textiles, clothing,","loael_value":"250 mg/kg bw/day","noael_unit":"mg/kg bw/day","noael_value":"1000","page":93,"route":"","species":"mouse","study_id":"sccs_o_291_noael_137"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies carcinogenicity 2.5 % rat oral 91-week carcinogenicity SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=2.5; DOSE=91-week dietary study in F344/DuCrj rats (20-24 male/group), no guideline | 0, 0.625, 1.25 and 2.5%, equivalent to 269, 531 and 1140 mg/kg bw/day | At 1140 mg/kg bw/day, ↑white blood cell count, haematuria, ↓body weights, proliferative lesions in the urinary bladder, and moderate to severe nephritic lesions and urinary bladder tumours (papilloma...; EFFECT=Unlabeled table on page 93: 91-week dietary study in F344/DuCrj rats (20-24 male/group), no guideline | 0, 0.625, 1.25 and 2.5%, equivalent to 269, 531 and 1140 mg/kg bw/day | At 1140 mg/kg bw/day, ↑white blood cell count, haematuria, ↓body weights, proliferative lesions in the urinary bladder, and moderate to severe nephritic lesions and urinary bladder tumours (papilloma and carcinoma, mainly transitional cell papilloma and carcinoma). were observed. At 531 mg/kg bw/day, haematuria, ↓body weights, proliferative lesions in the urinary bladder, and moderate to severe nephritic lesions and urinary bladder tumours (papilloma and carcinoma, mainly transitional cell papilloma and carcinoma) were observed. | NOAEL (carcinogenicity): 269 mg/kg bw/day | Hiraga K., and Fujii T. 1984 in (EC, 2023; ECHA, 2023b; ECHA RAC, 2022; SCCS, 2015)/KL2; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"91-week dietary study in F344/DuCrj rats (20-24 male/group), no guideline | 0, 0.625, 1.25 and 2.5%, equivalent to 269, 531 and 1140 mg/kg bw/day | At 1140 mg/kg bw/day, ↑white blood cell count, haematuria, ↓body weights, proliferative lesions in the urinary bladder, and moderate to severe nephritic lesions and urinary bladder tumours (papilloma...","duration":"91-week","effect":"Unlabeled table on page 93: 91-week dietary study in F344/DuCrj rats (20-24 male/group), no guideline | 0, 0.625, 1.25 and 2.5%, equivalent to 269, 531 and 1140 mg/kg bw/day | At 1140 mg/kg bw/day, ↑white blood cell count, haematuria, ↓body weights, proliferative lesions in the urinary bladder, and moderate to severe nephritic lesions and urinary bladder tumours (papilloma and carcinoma, mainly transitional cell papilloma and carcinoma). were observed. At 531 mg/kg bw/day, haematuria, ↓body weights, proliferative lesions in the urinary bladder, and moderate to severe nephritic lesions and urinary bladder tumours (papilloma and carcinoma, mainly transitional cell papilloma and carcinoma) were observed. | NOAEL (carcinogenicity): 269 mg/kg bw/day | Hiraga K., and Fujii T. 1984 in (EC, 2023; ECHA, 2023b; ECHA RAC, 2022; SCCS, 2015)/KL2","endpoint":"carcinogenicity","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"%","noael_value":"2.5","page":93,"route":"oral","species":"rat","study_id":"sccs_o_291_noael_138"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies carcinogenicity 10000 ppm rat - 2-year carcinogenicity SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=10000; DOSE=2-year combined chronic toxicity/ carcinogenicity study in CDF[F344]/BR rats | 0, 800, 4000 and 8000/ 10000 ppm (equivalent to 0, 39/49, 200/248 and 402/647 mg/kg bw/day in | At 402/647 mg/kg bw/day, ↑ incidence of urinary bladder masses, ↑ incidence of pitted zones in kidneys.; EFFECT=Unlabeled table on page 93: 2-year combined chronic toxicity/ carcinogenicity study in CDF[F344]/BR rats | 0, 800, 4000 and 8000/ 10000 ppm (equivalent to 0, 39/49, 200/248 and 402/647 mg/kg bw/day in | At 402/647 mg/kg bw/day, ↑ incidence of urinary bladder masses, ↑ incidence of pitted zones in kidneys. Neoplastic changes such as ↑ incidence of transitional | NOAEL (carcinogenicity and systemic toxicity): 39 and 49 mg/kg bw/day in males | Wahle et al...,1996 in (ECHA, 2023b; ECHA RAC, 2022;; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"2-year combined chronic toxicity/ carcinogenicity study in CDF[F344]/BR rats | 0, 800, 4000 and 8000/ 10000 ppm (equivalent to 0, 39/49, 200/248 and 402/647 mg/kg bw/day in | At 402/647 mg/kg bw/day, ↑ incidence of urinary bladder masses, ↑ incidence of pitted zones in kidneys.","duration":"2-year","effect":"Unlabeled table on page 93: 2-year combined chronic toxicity/ carcinogenicity study in CDF[F344]/BR rats | 0, 800, 4000 and 8000/ 10000 ppm (equivalent to 0, 39/49, 200/248 and 402/647 mg/kg bw/day in | At 402/647 mg/kg bw/day, ↑ incidence of urinary bladder masses, ↑ incidence of pitted zones in kidneys. Neoplastic changes such as ↑ incidence of transitional | NOAEL (carcinogenicity and systemic toxicity): 39 and 49 mg/kg bw/day in males | Wahle et al...,1996 in (ECHA, 2023b; ECHA RAC, 2022;","endpoint":"carcinogenicity","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"ppm","noael_value":"10000","page":93,"route":"","species":"rat","study_id":"sccs_o_291_noael_139"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies carcinogenicity 250 mg/kg bw/day mouse - 2-year carcinogenicity SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=250; DOSE=OECD TG 453 | 0, 250, 500 and 1000 mg/kg bw/day | At 1000 and 500 mg/kg bw/day, ↓ body weight, ↑ relative liver weights, absolute and relative brain weight, relative testes weights and reduced absolute weights of heart, kidneys, and spleen; ↑ incidences of adenoma, increase in hepatocellular adenoma were observed.; LOAEL_VALUE=250 mg/kg bw/day; EFFECT=Unlabeled table on page 93: 2-year combined chronic toxicity/ carcinogenicity study in B6C3F1 mice (50/sex/group); OECD TG 453 | 0, 250, 500 and 1000 mg/kg bw/day | At 1000 and 500 mg/kg bw/day, ↓ body weight, ↑ relative liver weights, absolute and relative brain weight, relative testes weights and reduced absolute weights of heart, kidneys, and spleen; ↑ incidences of adenoma, increase in hepatocellular adenoma were observed. At all doses, kidney hypertrophy and ↑ relative kidney weights were observed in females. | NOAEL (carcinogenicity): 250 mg/kg bw/day LOAEL (systemic toxicity): 250 mg/kg bw/day | Quast J.F. and McGuirk R.J. 1995 in (Cal EPA, 2007; EC, 2023; ECHA, 2023b; SCCS, 2015)/KL1; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"OECD TG 453 | 0, 250, 500 and 1000 mg/kg bw/day | At 1000 and 500 mg/kg bw/day, ↓ body weight, ↑ relative liver weights, absolute and relative brain weight, relative testes weights and reduced absolute weights of heart, kidneys, and spleen; ↑ incidences of adenoma, increase in hepatocellular adenoma were observed.","duration":"2-year","effect":"Unlabeled table on page 93: 2-year combined chronic toxicity/ carcinogenicity study in B6C3F1 mice (50/sex/group); OECD TG 453 | 0, 250, 500 and 1000 mg/kg bw/day | At 1000 and 500 mg/kg bw/day, ↓ body weight, ↑ relative liver weights, absolute and relative brain weight, relative testes weights and reduced absolute weights of heart, kidneys, and spleen; ↑ incidences of adenoma, increase in hepatocellular adenoma were observed. At all doses, kidney hypertrophy and ↑ relative kidney weights were observed in females. | NOAEL (carcinogenicity): 250 mg/kg bw/day LOAEL (systemic toxicity): 250 mg/kg bw/day | Quast J.F. and McGuirk R.J. 1995 in (Cal EPA, 2007; EC, 2023; ECHA, 2023b; SCCS, 2015)/KL1","endpoint":"carcinogenicity","ingredient":"s, toys, textiles, clothing,","loael_value":"250 mg/kg bw/day","noael_unit":"mg/kg bw/day","noael_value":"250","page":93,"route":"","species":"mouse","study_id":"sccs_o_291_noael_140"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies carcinogenicity 269 mg/kg bw/day rat oral 91-week carcinogenicity SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=269; DOSE=91-week dietary study in F344/DuCrj rats (20-24 male/group), no guideline | 0, 0.625, 1.25 and 2.5%, equivalent to 269, 531 and 1140 mg/kg bw/day | At 1140 mg/kg bw/day, ↑white blood cell count, haematuria, ↓body weights, proliferative lesions in the urinary bladder, and moderate to severe nephritic lesions and urinary bladder tumours (papilloma...; EFFECT=Unlabeled table on page 93: 91-week dietary study in F344/DuCrj rats (20-24 male/group), no guideline | 0, 0.625, 1.25 and 2.5%, equivalent to 269, 531 and 1140 mg/kg bw/day | At 1140 mg/kg bw/day, ↑white blood cell count, haematuria, ↓body weights, proliferative lesions in the urinary bladder, and moderate to severe nephritic lesions and urinary bladder tumours (papilloma and carcinoma, mainly transitional cell papilloma and carcinoma). were observed. At 531 mg/kg bw/day, haematuria, ↓body weights, proliferative lesions in the urinary bladder, and moderate to severe nephritic lesions and urinary bladder tumours (papilloma and carcinoma, mainly transitional cell papilloma and carcinoma) were observed. | NOAEL (carcinogenicity): 269 mg/kg bw/day | Hiraga K., and Fujii T. 1984 in (EC, 2023; ECHA, 2023b; ECHA RAC, 2022; SCCS, 2015)/KL2; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"91-week dietary study in F344/DuCrj rats (20-24 male/group), no guideline | 0, 0.625, 1.25 and 2.5%, equivalent to 269, 531 and 1140 mg/kg bw/day | At 1140 mg/kg bw/day, ↑white blood cell count, haematuria, ↓body weights, proliferative lesions in the urinary bladder, and moderate to severe nephritic lesions and urinary bladder tumours (papilloma...","duration":"91-week","effect":"Unlabeled table on page 93: 91-week dietary study in F344/DuCrj rats (20-24 male/group), no guideline | 0, 0.625, 1.25 and 2.5%, equivalent to 269, 531 and 1140 mg/kg bw/day | At 1140 mg/kg bw/day, ↑white blood cell count, haematuria, ↓body weights, proliferative lesions in the urinary bladder, and moderate to severe nephritic lesions and urinary bladder tumours (papilloma and carcinoma, mainly transitional cell papilloma and carcinoma). were observed. At 531 mg/kg bw/day, haematuria, ↓body weights, proliferative lesions in the urinary bladder, and moderate to severe nephritic lesions and urinary bladder tumours (papilloma and carcinoma, mainly transitional cell papilloma and carcinoma) were observed. | NOAEL (carcinogenicity): 269 mg/kg bw/day | Hiraga K., and Fujii T. 1984 in (EC, 2023; ECHA, 2023b; ECHA RAC, 2022; SCCS, 2015)/KL2","endpoint":"carcinogenicity","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"269","page":93,"route":"oral","species":"rat","study_id":"sccs_o_291_noael_141"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies carcinogenicity 49 mg/kg bw/day rat - 2-year carcinogenicity SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=49; DOSE=2-year combined chronic toxicity/ carcinogenicity study in CDF[F344]/BR rats | 0, 800, 4000 and 8000/ 10000 ppm (equivalent to 0, 39/49, 200/248 and 402/647 mg/kg bw/day in | At 402/647 mg/kg bw/day, ↑ incidence of urinary bladder masses, ↑ incidence of pitted zones in kidneys.; EFFECT=Unlabeled table on page 93: 2-year combined chronic toxicity/ carcinogenicity study in CDF[F344]/BR rats | 0, 800, 4000 and 8000/ 10000 ppm (equivalent to 0, 39/49, 200/248 and 402/647 mg/kg bw/day in | At 402/647 mg/kg bw/day, ↑ incidence of urinary bladder masses, ↑ incidence of pitted zones in kidneys. Neoplastic changes such as ↑ incidence of transitional | NOAEL (carcinogenicity and systemic toxicity): 39 and 49 mg/kg bw/day in males | Wahle et al...,1996 in (ECHA, 2023b; ECHA RAC, 2022;; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"2-year combined chronic toxicity/ carcinogenicity study in CDF[F344]/BR rats | 0, 800, 4000 and 8000/ 10000 ppm (equivalent to 0, 39/49, 200/248 and 402/647 mg/kg bw/day in | At 402/647 mg/kg bw/day, ↑ incidence of urinary bladder masses, ↑ incidence of pitted zones in kidneys.","duration":"2-year","effect":"Unlabeled table on page 93: 2-year combined chronic toxicity/ carcinogenicity study in CDF[F344]/BR rats | 0, 800, 4000 and 8000/ 10000 ppm (equivalent to 0, 39/49, 200/248 and 402/647 mg/kg bw/day in | At 402/647 mg/kg bw/day, ↑ incidence of urinary bladder masses, ↑ incidence of pitted zones in kidneys. Neoplastic changes such as ↑ incidence of transitional | NOAEL (carcinogenicity and systemic toxicity): 39 and 49 mg/kg bw/day in males | Wahle et al...,1996 in (ECHA, 2023b; ECHA RAC, 2022;","endpoint":"carcinogenicity","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"49","page":93,"route":"","species":"rat","study_id":"sccs_o_291_noael_142"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies carcinogenicity 2 % rat - 2-year carcinogenicity SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=2; DOSE=Similar to OECD TG 453 | 0, 0.02, 0.2 and 2% equivalent to 0, 10, 100 and 1000 mg/kg bw/day | At 1000 mg/kg bw/day, ↓ body weight, ↑weight of testes and histopathological changes such as extensive renal damage, characterised by tubular dilation with varying degrees of acute and chronic inflammation was observed. | NOAEL:; EFFECT=Unlabeled table on page 94: 2-year combined chronic toxicity/ carcinogenicity study in weanling Rochester rats (25/sex/group); Similar to OECD TG 453 | 0, 0.02, 0.2 and 2% equivalent to 0, 10, 100 and 1000 mg/kg bw/day | At 1000 mg/kg bw/day, ↓ body weight, ↑weight of testes and histopathological changes such as extensive renal damage, characterised by tubular dilation with varying degrees of acute and chronic inflammation was observed. | NOAEL: 100 mg/kg bw/day | Hodge HC., et al... 1952 in (EC, 2023)/KL2; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"Similar to OECD TG 453 | 0, 0.02, 0.2 and 2% equivalent to 0, 10, 100 and 1000 mg/kg bw/day | At 1000 mg/kg bw/day, ↓ body weight, ↑weight of testes and histopathological changes such as extensive renal damage, characterised by tubular dilation with varying degrees of acute and chronic inflammation was observed. | NOAEL:","duration":"2-year","effect":"Unlabeled table on page 94: 2-year combined chronic toxicity/ carcinogenicity study in weanling Rochester rats (25/sex/group); Similar to OECD TG 453 | 0, 0.02, 0.2 and 2% equivalent to 0, 10, 100 and 1000 mg/kg bw/day | At 1000 mg/kg bw/day, ↓ body weight, ↑weight of testes and histopathological changes such as extensive renal damage, characterised by tubular dilation with varying degrees of acute and chronic inflammation was observed. | NOAEL: 100 mg/kg bw/day | Hodge HC., et al... 1952 in (EC, 2023)/KL2","endpoint":"carcinogenicity","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"%","noael_value":"2","page":94,"route":"","species":"rat","study_id":"sccs_o_291_noael_144"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies carcinogenicity 100 mg/kg bw/day rat - 2-year carcinogenicity SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=100; DOSE=Similar to OECD TG 453 | 0, 0.02, 0.2 and 2% equivalent to 0, 10, 100 and 1000 mg/kg bw/day | At 1000 mg/kg bw/day, ↓ body weight, ↑weight of testes and histopathological changes such as extensive renal damage, characterised by tubular dilation with varying degrees of acute and chronic inflammation was observed. | NOAEL:; EFFECT=Unlabeled table on page 94: 2-year combined chronic toxicity/ carcinogenicity study in weanling Rochester rats (25/sex/group); Similar to OECD TG 453 | 0, 0.02, 0.2 and 2% equivalent to 0, 10, 100 and 1000 mg/kg bw/day | At 1000 mg/kg bw/day, ↓ body weight, ↑weight of testes and histopathological changes such as extensive renal damage, characterised by tubular dilation with varying degrees of acute and chronic inflammation was observed. | NOAEL: 100 mg/kg bw/day | Hodge HC., et al... 1952 in (EC, 2023)/KL2; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"Similar to OECD TG 453 | 0, 0.02, 0.2 and 2% equivalent to 0, 10, 100 and 1000 mg/kg bw/day | At 1000 mg/kg bw/day, ↓ body weight, ↑weight of testes and histopathological changes such as extensive renal damage, characterised by tubular dilation with varying degrees of acute and chronic inflammation was observed. | NOAEL:","duration":"2-year","effect":"Unlabeled table on page 94: 2-year combined chronic toxicity/ carcinogenicity study in weanling Rochester rats (25/sex/group); Similar to OECD TG 453 | 0, 0.02, 0.2 and 2% equivalent to 0, 10, 100 and 1000 mg/kg bw/day | At 1000 mg/kg bw/day, ↓ body weight, ↑weight of testes and histopathological changes such as extensive renal damage, characterised by tubular dilation with varying degrees of acute and chronic inflammation was observed. | NOAEL: 100 mg/kg bw/day | Hodge HC., et al... 1952 in (EC, 2023)/KL2","endpoint":"carcinogenicity","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"100","page":94,"route":"","species":"rat","study_id":"sccs_o_291_noael_147"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies carcinogenicity 4 % rat oral 91-week carcinogenicity SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=4.0; DOSE=91-week dietary carcinogenicity study in F344/Du rats (20 males/ group; no guideline | 0, 0.125, 0.25, 0.5, 1.0, 2.0 and 4.0% equivalent to 0, 62, 125, 250, 500, 1000 and 2000 mg/kg bw/dayk | At 2000 mg/kg bw/day, ↑incidence of carcinoma in the renal papilla was observed.; LOAEL_VALUE=62 mg/kg bw/day; EFFECT=Unlabeled table on page 95: 91-week dietary carcinogenicity study in F344/Du rats (20 males/ group; no guideline | 0, 0.125, 0.25, 0.5, 1.0, 2.0 and 4.0% equivalent to 0, 62, 125, 250, 500, 1000 and 2000 mg/kg bw/dayk | At 2000 mg/kg bw/day, ↑incidence of carcinoma in the renal papilla was observed. At 1000 mg/kg bw/day, ↑ in the incidence of tumours of the urinary system and carcinosarcoma was observed. At 500 mg/kg bw/day, ↑in the incidence of tumours of the urinary system was observed. At 250 mg/kg bw/day, ↑in the incidence of tumours of the urinary system was observed. Haematuria was observed at all dose levels. | NOAEL (carcinogenicity): 125 mg/kg bw/day LOAEL (systemic toxicity): 62 mg/kg bw/day | Hiraga et al..., 1981 in (SCCS, 2015)/KL2; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"91-week dietary carcinogenicity study in F344/Du rats (20 males/ group; no guideline | 0, 0.125, 0.25, 0.5, 1.0, 2.0 and 4.0% equivalent to 0, 62, 125, 250, 500, 1000 and 2000 mg/kg bw/dayk | At 2000 mg/kg bw/day, ↑incidence of carcinoma in the renal papilla was observed.","duration":"91-week","effect":"Unlabeled table on page 95: 91-week dietary carcinogenicity study in F344/Du rats (20 males/ group; no guideline | 0, 0.125, 0.25, 0.5, 1.0, 2.0 and 4.0% equivalent to 0, 62, 125, 250, 500, 1000 and 2000 mg/kg bw/dayk | At 2000 mg/kg bw/day, ↑incidence of carcinoma in the renal papilla was observed. At 1000 mg/kg bw/day, ↑ in the incidence of tumours of the urinary system and carcinosarcoma was observed. At 500 mg/kg bw/day, ↑in the incidence of tumours of the urinary system was observed. At 250 mg/kg bw/day, ↑in the incidence of tumours of the urinary system was observed. Haematuria was observed at all dose levels. | NOAEL (carcinogenicity): 125 mg/kg bw/day LOAEL (systemic toxicity): 62 mg/kg bw/day | Hiraga et al..., 1981 in (SCCS, 2015)/KL2","endpoint":"carcinogenicity","ingredient":"s, toys, textiles, clothing,","loael_value":"62 mg/kg bw/day","noael_unit":"%","noael_value":"4.0","page":95,"route":"oral","species":"rat","study_id":"sccs_o_291_noael_149"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies carcinogenicity 3009 mg/kg bw/day mouse - - carcinogenicity SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=3009; DOSE=Unlabeled table on page 95: study in B6C3F1 mice (50/sex/group); no guideline | equivalent to 0, 591, 1451, and 3009 mg/kg bw/day for the males and 0, 480, 1464, and 3081 mg/kg bw/day for the females, respectively | ↑hepatocellular carcinomas and calcification of the brain were observed.; LOAEL_VALUE=480 mg/kg bw/day; EFFECT=Unlabeled table on page 95: study in B6C3F1 mice (50/sex/group); no guideline | equivalent to 0, 591, 1451, and 3009 mg/kg bw/day for the males and 0, 480, 1464, and 3081 mg/kg bw/day for the females, respectively | ↑hepatocellular carcinomas and calcification of the brain were observed. At 1451/1464 mg/kg bw/day ↑ haemangiosarcomas of the liver, ↑hepatocellular carcinomas were observed. At 480 mg/kg bw/day, cystic endometrial hyperplasia of the uterus in females was observed in females. Authors considered increased incidence of hepatocellular carcinomas at 3009 and 1451 mg/kg bw/day in males might be due to an unusually low incidence in control mice (8.2%), which was in contrast to the average spontaneous rate of this tumour in that lab (20.1%). With respect to the increase of haemangiosarcomas in 1451 mg/kg bw/day males, the authors concluded that the finding was unexpected as changes were due to unusually low incidences in control. animals and not dose related. | (carcinogenicity): 3009 mg/kg bw/day LOAEL (systemic toxicity): 480 mg/kg bw/day | al..., 1984 in (SCCS, 2015)/KL2; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"Unlabeled table on page 95: study in B6C3F1 mice (50/sex/group); no guideline | equivalent to 0, 591, 1451, and 3009 mg/kg bw/day for the males and 0, 480, 1464, and 3081 mg/kg bw/day for the females, respectively | ↑hepatocellular carcinomas and calcification of the brain were observed.","duration":"","effect":"Unlabeled table on page 95: study in B6C3F1 mice (50/sex/group); no guideline | equivalent to 0, 591, 1451, and 3009 mg/kg bw/day for the males and 0, 480, 1464, and 3081 mg/kg bw/day for the females, respectively | ↑hepatocellular carcinomas and calcification of the brain were observed. At 1451/1464 mg/kg bw/day ↑ haemangiosarcomas of the liver, ↑hepatocellular carcinomas were observed. At 480 mg/kg bw/day, cystic endometrial hyperplasia of the uterus in females was observed in females. Authors considered increased incidence of hepatocellular carcinomas at 3009 and 1451 mg/kg bw/day in males might be due to an unusually low incidence in control mice (8.2%), which was in contrast to the average spontaneous rate of this tumour in that lab (20.1%). With respect to the increase of haemangiosarcomas in 1451 mg/kg bw/day males, the authors concluded that the finding was unexpected as changes were due to unusually low incidences in control. animals and not dose related. | (carcinogenicity): 3009 mg/kg bw/day LOAEL (systemic toxicity): 480 mg/kg bw/day | al..., 1984 in (SCCS, 2015)/KL2","endpoint":"carcinogenicity","ingredient":"s, toys, textiles, clothing,","loael_value":"480 mg/kg bw/day","noael_unit":"mg/kg bw/day","noael_value":"3009","page":95,"route":"","species":"mouse","study_id":"sccs_o_291_noael_150"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies carcinogenicity 125 mg/kg bw/day rat oral 91-week carcinogenicity SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=125; DOSE=91-week dietary carcinogenicity study in F344/Du rats (20 males/ group; no guideline | 0, 0.125, 0.25, 0.5, 1.0, 2.0 and 4.0% equivalent to 0, 62, 125, 250, 500, 1000 and 2000 mg/kg bw/dayk | At 2000 mg/kg bw/day, ↑incidence of carcinoma in the renal papilla was observed.; LOAEL_VALUE=62 mg/kg bw/day; EFFECT=Unlabeled table on page 95: 91-week dietary carcinogenicity study in F344/Du rats (20 males/ group; no guideline | 0, 0.125, 0.25, 0.5, 1.0, 2.0 and 4.0% equivalent to 0, 62, 125, 250, 500, 1000 and 2000 mg/kg bw/dayk | At 2000 mg/kg bw/day, ↑incidence of carcinoma in the renal papilla was observed. At 1000 mg/kg bw/day, ↑ in the incidence of tumours of the urinary system and carcinosarcoma was observed. At 500 mg/kg bw/day, ↑in the incidence of tumours of the urinary system was observed. At 250 mg/kg bw/day, ↑in the incidence of tumours of the urinary system was observed. Haematuria was observed at all dose levels. | NOAEL (carcinogenicity): 125 mg/kg bw/day LOAEL (systemic toxicity): 62 mg/kg bw/day | Hiraga et al..., 1981 in (SCCS, 2015)/KL2; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"91-week dietary carcinogenicity study in F344/Du rats (20 males/ group; no guideline | 0, 0.125, 0.25, 0.5, 1.0, 2.0 and 4.0% equivalent to 0, 62, 125, 250, 500, 1000 and 2000 mg/kg bw/dayk | At 2000 mg/kg bw/day, ↑incidence of carcinoma in the renal papilla was observed.","duration":"91-week","effect":"Unlabeled table on page 95: 91-week dietary carcinogenicity study in F344/Du rats (20 males/ group; no guideline | 0, 0.125, 0.25, 0.5, 1.0, 2.0 and 4.0% equivalent to 0, 62, 125, 250, 500, 1000 and 2000 mg/kg bw/dayk | At 2000 mg/kg bw/day, ↑incidence of carcinoma in the renal papilla was observed. At 1000 mg/kg bw/day, ↑ in the incidence of tumours of the urinary system and carcinosarcoma was observed. At 500 mg/kg bw/day, ↑in the incidence of tumours of the urinary system was observed. At 250 mg/kg bw/day, ↑in the incidence of tumours of the urinary system was observed. Haematuria was observed at all dose levels. | NOAEL (carcinogenicity): 125 mg/kg bw/day LOAEL (systemic toxicity): 62 mg/kg bw/day | Hiraga et al..., 1981 in (SCCS, 2015)/KL2","endpoint":"carcinogenicity","ingredient":"s, toys, textiles, clothing,","loael_value":"62 mg/kg bw/day","noael_unit":"mg/kg bw/day","noael_value":"125","page":95,"route":"oral","species":"rat","study_id":"sccs_o_291_noael_151"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies carcinogenicity 20000 ppm - oral 2-year carcinogenicity SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=20000; DOSE=0, 7000 and 20000 ppm, | At 466/770 mg/kg bw/day, ↑ focal atrophy of the | LOAEL (carcinogenicity | Hiraga et al..., 1983 in (SCCS,; EFFECT=Unlabeled table on page 95: 2-year dietary carcinogenicity | 1st study: Males: 0, 7000 and 20000 ppm, | At 466/770 mg/kg bw/day, ↑ focal atrophy of the | LOAEL (carcinogenicity | Hiraga et al..., 1983 in (SCCS,; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"0, 7000 and 20000 ppm, | At 466/770 mg/kg bw/day, ↑ focal atrophy of the | LOAEL (carcinogenicity | Hiraga et al..., 1983 in (SCCS,","duration":"2-year","effect":"Unlabeled table on page 95: 2-year dietary carcinogenicity | 1st study: Males: 0, 7000 and 20000 ppm, | At 466/770 mg/kg bw/day, ↑ focal atrophy of the | LOAEL (carcinogenicity | Hiraga et al..., 1983 in (SCCS,","endpoint":"carcinogenicity","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"ppm","noael_value":"20000","page":95,"route":"oral","species":"","study_id":"sccs_o_291_noael_152"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies carcinogenicity 20000 ppm rat oral 2-year carcinogenicity SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=20000; DOSE=2-year dietary carcinogenicity study in F344 rats (25/ sex/ group); no guideline | 2nd study 0, 2500, 7000 and 20000 ppm equivalent to 0, 95, 270 and 770 mg/kg bw/day in males;; EFFECT=Unlabeled table on page 96: 2-year dietary carcinogenicity study in F344 rats (25/ sex/ group); no guideline | 2nd study 0, 2500, 7000 and 20000 ppm equivalent to 0, 95, 270 and 770 mg/kg bw/day in males; 0, 2500, 5000 and 10000 ppm equivalent to 0, 113, 224 and 466 mg/kg bw/day in females with a 56-week recovery period | At 466/770 mg/kg bw/day, kidney, bladder lesions and↑ incidences of interstitial nephritis of the kidney in females, ↓ body weights and haematuria were observed in males. At 224/270 mg/kg bw/day, ↑ incidences of interstitial nephritis of the kidney, urinary bladder papillomas and/or carcinomas were observed. | NOAEL (carcinogenicity and systemic toxicity): 95 mg/kg bw/day; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"2-year dietary carcinogenicity study in F344 rats (25/ sex/ group); no guideline | 2nd study 0, 2500, 7000 and 20000 ppm equivalent to 0, 95, 270 and 770 mg/kg bw/day in males;","duration":"2-year","effect":"Unlabeled table on page 96: 2-year dietary carcinogenicity study in F344 rats (25/ sex/ group); no guideline | 2nd study 0, 2500, 7000 and 20000 ppm equivalent to 0, 95, 270 and 770 mg/kg bw/day in males; 0, 2500, 5000 and 10000 ppm equivalent to 0, 113, 224 and 466 mg/kg bw/day in females with a 56-week recovery period | At 466/770 mg/kg bw/day, kidney, bladder lesions and↑ incidences of interstitial nephritis of the kidney in females, ↓ body weights and haematuria were observed in males. At 224/270 mg/kg bw/day, ↑ incidences of interstitial nephritis of the kidney, urinary bladder papillomas and/or carcinomas were observed. | NOAEL (carcinogenicity and systemic toxicity): 95 mg/kg bw/day","endpoint":"carcinogenicity","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"ppm","noael_value":"20000","page":96,"route":"oral","species":"rat","study_id":"sccs_o_291_noael_154"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies carcinogenicity 2 % rat - 2-year carcinogenicity SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=2.0; DOSE=2-year carcinogenicity study in male F344 rats (groups not specified); no guideline | 0, 0.25, 0.5, 1.0 and 2.0% equivalent to approximately 0, 197, 395, 780 and 1579 mg/kg bw/dayl | At 1579 mg/kg bw/day, hyperplasia of bladder was observed.; EFFECT=Unlabeled table on page 96: 2-year carcinogenicity study in male F344 rats (groups not specified); no guideline | 0, 0.25, 0.5, 1.0 and 2.0% equivalent to approximately 0, 197, 395, 780 and 1579 mg/kg bw/dayl | At 1579 mg/kg bw/day, hyperplasia of bladder was observed. Development of papilloma and carcinoma was observed after 36 weeks. At 780 mg/kg bw/day, development of simple hyperplasia from week 36 was observed. | NOAEL (carcinogenicity and systemic toxicity): 395 mg/kg bw/day | Fukushima et al..., 1982 in (SCCS, 2015)/KL4; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"2-year carcinogenicity study in male F344 rats (groups not specified); no guideline | 0, 0.25, 0.5, 1.0 and 2.0% equivalent to approximately 0, 197, 395, 780 and 1579 mg/kg bw/dayl | At 1579 mg/kg bw/day, hyperplasia of bladder was observed.","duration":"2-year","effect":"Unlabeled table on page 96: 2-year carcinogenicity study in male F344 rats (groups not specified); no guideline | 0, 0.25, 0.5, 1.0 and 2.0% equivalent to approximately 0, 197, 395, 780 and 1579 mg/kg bw/dayl | At 1579 mg/kg bw/day, hyperplasia of bladder was observed. Development of papilloma and carcinoma was observed after 36 weeks. At 780 mg/kg bw/day, development of simple hyperplasia from week 36 was observed. | NOAEL (carcinogenicity and systemic toxicity): 395 mg/kg bw/day | Fukushima et al..., 1982 in (SCCS, 2015)/KL4","endpoint":"carcinogenicity","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"%","noael_value":"2.0","page":96,"route":"","species":"rat","study_id":"sccs_o_291_noael_155"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies carcinogenicity 20000 ppm - - 112-week carcinogenicity SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=20000; DOSE=112-week carcinogenicity | 0, 2500, 5000, 10000, 15000 and 20000 ppm | At 1500 mg/kg bw/day, transitional cell carcinoma | NOAEL (carcinogenicity | Niho et al..., 2002 in (SCCS,; EFFECT=Unlabeled table on page 96: 112-week carcinogenicity | 0, 2500, 5000, 10000, 15000 and 20000 ppm | At 1500 mg/kg bw/day, transitional cell carcinoma | NOAEL (carcinogenicity | Niho et al..., 2002 in (SCCS,; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"112-week carcinogenicity | 0, 2500, 5000, 10000, 15000 and 20000 ppm | At 1500 mg/kg bw/day, transitional cell carcinoma | NOAEL (carcinogenicity | Niho et al..., 2002 in (SCCS,","duration":"112-week","effect":"Unlabeled table on page 96: 112-week carcinogenicity | 0, 2500, 5000, 10000, 15000 and 20000 ppm | At 1500 mg/kg bw/day, transitional cell carcinoma | NOAEL (carcinogenicity | Niho et al..., 2002 in (SCCS,","endpoint":"carcinogenicity","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"ppm","noael_value":"20000","page":96,"route":"","species":"","study_id":"sccs_o_291_noael_156"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies carcinogenicity 95 mg/kg bw/day rat oral 2-year carcinogenicity SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=95; DOSE=2-year dietary carcinogenicity study in F344 rats (25/ sex/ group); no guideline | 2nd study 0, 2500, 7000 and 20000 ppm equivalent to 0, 95, 270 and 770 mg/kg bw/day in males;; EFFECT=Unlabeled table on page 96: 2-year dietary carcinogenicity study in F344 rats (25/ sex/ group); no guideline | 2nd study 0, 2500, 7000 and 20000 ppm equivalent to 0, 95, 270 and 770 mg/kg bw/day in males; 0, 2500, 5000 and 10000 ppm equivalent to 0, 113, 224 and 466 mg/kg bw/day in females with a 56-week recovery period | At 466/770 mg/kg bw/day, kidney, bladder lesions and↑ incidences of interstitial nephritis of the kidney in females, ↓ body weights and haematuria were observed in males. At 224/270 mg/kg bw/day, ↑ incidences of interstitial nephritis of the kidney, urinary bladder papillomas and/or carcinomas were observed. | NOAEL (carcinogenicity and systemic toxicity): 95 mg/kg bw/day; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"2-year dietary carcinogenicity study in F344 rats (25/ sex/ group); no guideline | 2nd study 0, 2500, 7000 and 20000 ppm equivalent to 0, 95, 270 and 770 mg/kg bw/day in males;","duration":"2-year","effect":"Unlabeled table on page 96: 2-year dietary carcinogenicity study in F344 rats (25/ sex/ group); no guideline | 2nd study 0, 2500, 7000 and 20000 ppm equivalent to 0, 95, 270 and 770 mg/kg bw/day in males; 0, 2500, 5000 and 10000 ppm equivalent to 0, 113, 224 and 466 mg/kg bw/day in females with a 56-week recovery period | At 466/770 mg/kg bw/day, kidney, bladder lesions and↑ incidences of interstitial nephritis of the kidney in females, ↓ body weights and haematuria were observed in males. At 224/270 mg/kg bw/day, ↑ incidences of interstitial nephritis of the kidney, urinary bladder papillomas and/or carcinomas were observed. | NOAEL (carcinogenicity and systemic toxicity): 95 mg/kg bw/day","endpoint":"carcinogenicity","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"95","page":96,"route":"oral","species":"rat","study_id":"sccs_o_291_noael_158"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies carcinogenicity 395 mg/kg bw/day rat - 2-year carcinogenicity SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=395; DOSE=2-year carcinogenicity study in male F344 rats (groups not specified); no guideline | 0, 0.25, 0.5, 1.0 and 2.0% equivalent to approximately 0, 197, 395, 780 and 1579 mg/kg bw/dayl | At 1579 mg/kg bw/day, hyperplasia of bladder was observed.; EFFECT=Unlabeled table on page 96: 2-year carcinogenicity study in male F344 rats (groups not specified); no guideline | 0, 0.25, 0.5, 1.0 and 2.0% equivalent to approximately 0, 197, 395, 780 and 1579 mg/kg bw/dayl | At 1579 mg/kg bw/day, hyperplasia of bladder was observed. Development of papilloma and carcinoma was observed after 36 weeks. At 780 mg/kg bw/day, development of simple hyperplasia from week 36 was observed. | NOAEL (carcinogenicity and systemic toxicity): 395 mg/kg bw/day | Fukushima et al..., 1982 in (SCCS, 2015)/KL4; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"2-year carcinogenicity study in male F344 rats (groups not specified); no guideline | 0, 0.25, 0.5, 1.0 and 2.0% equivalent to approximately 0, 197, 395, 780 and 1579 mg/kg bw/dayl | At 1579 mg/kg bw/day, hyperplasia of bladder was observed.","duration":"2-year","effect":"Unlabeled table on page 96: 2-year carcinogenicity study in male F344 rats (groups not specified); no guideline | 0, 0.25, 0.5, 1.0 and 2.0% equivalent to approximately 0, 197, 395, 780 and 1579 mg/kg bw/dayl | At 1579 mg/kg bw/day, hyperplasia of bladder was observed. Development of papilloma and carcinoma was observed after 36 weeks. At 780 mg/kg bw/day, development of simple hyperplasia from week 36 was observed. | NOAEL (carcinogenicity and systemic toxicity): 395 mg/kg bw/day | Fukushima et al..., 1982 in (SCCS, 2015)/KL4","endpoint":"carcinogenicity","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"395","page":96,"route":"","species":"rat","study_id":"sccs_o_291_noael_159"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 100 mg/kg/d rat - developmental developmental toxicity SOURCE_SUBDIR=sccs_o_177; REPORT_TITLE=OPINION ON o-Phenylphenol, Sodium o-phenylphenate and Potassium o-phenylphenate; OPINION_NUMBER=SCCS/1555/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=15 December 2015; VALUE_TEXT=100; DOSE=11.1 – 66.7 %) were observed at 100 (77 %) and 250 (72 %) mg/kg/d.; EFFECT=nomalies or malformations (data not shown). The only developmental effect of OPP in rabbits was increased incidence of litters with resorptions. Kwock and Silva (2013) carefully re-examined all available data considering probable statistical pitfalls. They came to the conclusion that statistically significant increases in resorptions clearly exceeding the actual control group (33.3 %) and the mean of historical controls (36.2 %, range: 11.1 – 66.7 %) were observed at 100 (77 %) and 250 (72 %) mg/kg/d. The maternal NOAEL was set at 100 mg/kg/d and the developmental NOAEL was set at 25 mg/kg/d. A NOAEL of 25 mg/kg bw/d will be taken for MOS calculation. Ref.: 319; Kwock and Silva (2013) Rats In a study from the open literature, OPP (commercial grade biocide, 99.69 % purity) at dose levels of 0, 100, 300 and 700 mg/kg bw/d was investigated in pregnant Sprague- Dawley rats (24 – 26 dams/dose; 36 control animals) for embryotoxic and teratogenic effects. Dose levels were based on the results of a range-finding study. One dam died at; CITATION=Ref.: 319; CITATION_NUMBERS=[319]; REFERENCE=Ref.: 319; DETAILS_JSON={"cas_number":"90-43-7","citation":"Ref.: 319","dose":"11.1 – 66.7 %) were observed at 100 (77 %) and 250 (72 %) mg/kg/d.","duration":"developmental","effect":"nomalies or malformations (data not shown). The only developmental effect of OPP in rabbits was increased incidence of litters with resorptions. Kwock and Silva (2013) carefully re-examined all available data considering probable statistical pitfalls. They came to the conclusion that statistically significant increases in resorptions clearly exceeding the actual control group (33.3 %) and the mean of historical controls (36.2 %, range: 11.1 – 66.7 %) were observed at 100 (77 %) and 250 (72 %) mg/kg/d. The maternal NOAEL was set at 100 mg/kg/d and the developmental NOAEL was set at 25 mg/kg/d. A NOAEL of 25 mg/kg bw/d will be taken for MOS calculation. Ref.: 319; Kwock and Silva (2013) Rats In a study from the open literature, OPP (commercial grade biocide, 99.69 % purity) at dose levels of 0, 100, 300 and 700 mg/kg bw/d was investigated in pregnant Sprague- Dawley rats (24 – 26 dams/dose; 36 control animals) for embryotoxic and teratogenic effects. Dose levels were based on the results of a range-finding study. One dam died at","endpoint":"developmental toxicity","ingredient":"codes.................................... 9","loael_value":"","noael_unit":"mg/kg/d","noael_value":"100","page":35,"route":"","species":"rat","study_id":"sccs_o_177_noael_010"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 25 mg/kg/d rat - developmental developmental toxicity SOURCE_SUBDIR=sccs_o_177; REPORT_TITLE=OPINION ON o-Phenylphenol, Sodium o-phenylphenate and Potassium o-phenylphenate; OPINION_NUMBER=SCCS/1555/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=15 December 2015; VALUE_TEXT=25; DOSE=11.1 – 66.7 %) were observed at 100 (77 %) and 250 (72 %) mg/kg/d.; EFFECT=y developmental effect of OPP in rabbits was increased incidence of litters with resorptions. Kwock and Silva (2013) carefully re-examined all available data considering probable statistical pitfalls. They came to the conclusion that statistically significant increases in resorptions clearly exceeding the actual control group (33.3 %) and the mean of historical controls (36.2 %, range: 11.1 – 66.7 %) were observed at 100 (77 %) and 250 (72 %) mg/kg/d. The maternal NOAEL was set at 100 mg/kg/d and the developmental NOAEL was set at 25 mg/kg/d. A NOAEL of 25 mg/kg bw/d will be taken for MOS calculation. Ref.: 319; Kwock and Silva (2013) Rats In a study from the open literature, OPP (commercial grade biocide, 99.69 % purity) at dose levels of 0, 100, 300 and 700 mg/kg bw/d was investigated in pregnant Sprague- Dawley rats (24 – 26 dams/dose; 36 control animals) for embryotoxic and teratogenic effects. Dose levels were based on the results of a range-finding study. One dam died at 700 mg/kg bw/day due to dosing error but there were; CITATION=Ref.: 319; CITATION_NUMBERS=[319]; REFERENCE=Ref.: 319; DETAILS_JSON={"cas_number":"90-43-7","citation":"Ref.: 319","dose":"11.1 – 66.7 %) were observed at 100 (77 %) and 250 (72 %) mg/kg/d.","duration":"developmental","effect":"y developmental effect of OPP in rabbits was increased incidence of litters with resorptions. Kwock and Silva (2013) carefully re-examined all available data considering probable statistical pitfalls. They came to the conclusion that statistically significant increases in resorptions clearly exceeding the actual control group (33.3 %) and the mean of historical controls (36.2 %, range: 11.1 – 66.7 %) were observed at 100 (77 %) and 250 (72 %) mg/kg/d. The maternal NOAEL was set at 100 mg/kg/d and the developmental NOAEL was set at 25 mg/kg/d. A NOAEL of 25 mg/kg bw/d will be taken for MOS calculation. Ref.: 319; Kwock and Silva (2013) Rats In a study from the open literature, OPP (commercial grade biocide, 99.69 % purity) at dose levels of 0, 100, 300 and 700 mg/kg bw/d was investigated in pregnant Sprague- Dawley rats (24 – 26 dams/dose; 36 control animals) for embryotoxic and teratogenic effects. Dose levels were based on the results of a range-finding study. One dam died at 700 mg/kg bw/day due to dosing error but there were","endpoint":"developmental toxicity","ingredient":"codes.................................... 9","loael_value":"","noael_unit":"mg/kg/d","noael_value":"25","page":35,"route":"","species":"rat","study_id":"sccs_o_177_noael_011"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 25 mg/kg/d rat - developmental developmental toxicity SOURCE_SUBDIR=sccs_o_177; REPORT_TITLE=OPINION ON o-Phenylphenol, Sodium o-phenylphenate and Potassium o-phenylphenate; OPINION_NUMBER=SCCS/1555/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=15 December 2015; VALUE_TEXT=25; DOSE=11.1 – 66.7 %) were observed at 100 (77 %) and 250 (72 %) mg/kg/d.; EFFECT=rabbits was increased incidence of litters with resorptions. Kwock and Silva (2013) carefully re-examined all available data considering probable statistical pitfalls. They came to the conclusion that statistically significant increases in resorptions clearly exceeding the actual control group (33.3 %) and the mean of historical controls (36.2 %, range: 11.1 – 66.7 %) were observed at 100 (77 %) and 250 (72 %) mg/kg/d. The maternal NOAEL was set at 100 mg/kg/d and the developmental NOAEL was set at 25 mg/kg/d. A NOAEL of 25 mg/kg bw/d will be taken for MOS calculation. Ref.: 319; Kwock and Silva (2013) Rats In a study from the open literature, OPP (commercial grade biocide, 99.69 % purity) at dose levels of 0, 100, 300 and 700 mg/kg bw/d was investigated in pregnant Sprague- Dawley rats (24 – 26 dams/dose; 36 control animals) for embryotoxic and teratogenic effects. Dose levels were based on the results of a range-finding study. One dam died at 700 mg/kg bw/day due to dosing error but there were no treatment-related deaths. Ma; CITATION=Ref.: 319; CITATION_NUMBERS=[319]; REFERENCE=Ref.: 319; DETAILS_JSON={"cas_number":"90-43-7","citation":"Ref.: 319","dose":"11.1 – 66.7 %) were observed at 100 (77 %) and 250 (72 %) mg/kg/d.","duration":"developmental","effect":"rabbits was increased incidence of litters with resorptions. Kwock and Silva (2013) carefully re-examined all available data considering probable statistical pitfalls. They came to the conclusion that statistically significant increases in resorptions clearly exceeding the actual control group (33.3 %) and the mean of historical controls (36.2 %, range: 11.1 – 66.7 %) were observed at 100 (77 %) and 250 (72 %) mg/kg/d. The maternal NOAEL was set at 100 mg/kg/d and the developmental NOAEL was set at 25 mg/kg/d. A NOAEL of 25 mg/kg bw/d will be taken for MOS calculation. Ref.: 319; Kwock and Silva (2013) Rats In a study from the open literature, OPP (commercial grade biocide, 99.69 % purity) at dose levels of 0, 100, 300 and 700 mg/kg bw/d was investigated in pregnant Sprague- Dawley rats (24 – 26 dams/dose; 36 control animals) for embryotoxic and teratogenic effects. Dose levels were based on the results of a range-finding study. One dam died at 700 mg/kg bw/day due to dosing error but there were no treatment-related deaths. Ma","endpoint":"developmental toxicity","ingredient":"codes.................................... 9","loael_value":"","noael_unit":"mg/kg/d","noael_value":"25","page":35,"route":"","species":"rat","study_id":"sccs_o_177_noael_012"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 150 mg/kg mouse - developmental developmental toxicity SOURCE_SUBDIR=sccs_o_177; REPORT_TITLE=OPINION ON o-Phenylphenol, Sodium o-phenylphenate and Potassium o-phenylphenate; OPINION_NUMBER=SCCS/1555/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=15 December 2015; VALUE_TEXT=150; DOSE=At ≥ 300 mg/kg bw/d, pregnant animals fell into ataxia for several hours and there was a dose-related increase.; EFFECT=g/kg bw/d, 2 of the 20 dams died. At ≥ 300 mg/kg bw/d, pregnant animals fell into ataxia for several hours and there was a dose-related increase. At doses ≥ 300 mg/kg bw/d, dams had decreased body weight gains from GD 9. Effects to foetuses from OPP exposure in utero at the 600 mg/kg bw/d group appeared as an increased (p<0.01) incidence of resorptions and reduced foetal body weights (both sexes). From the results of the study it can be concluded that foetal effects occurred at maternally toxic doses. The maternal NOAEL can be set at 150 mg/kg be/d based on decreased body weight gain and occurrence of ataxia from 300 mg/kg bw/d. The foetal (developmental) NOAEL can be set at 600 mg/kg bw/d based on reduced foetal body weight and an increased incidence of resorptions. Ref.:133; Kwock and Silva (2013) Mice The developmental toxicity of OPP (from Tokyo Kasei Ltd., Lot FB 103) and SOPP (from Dow, Lot MM0144) has been investigated in mice. No information on guideline adherence or GLP is available. In the study with OPP, four groups; CITATION=Ref.:133; CITATION_NUMBERS=[133]; REFERENCE=Ref.:133; DETAILS_JSON={"cas_number":"90-43-7","citation":"Ref.:133","dose":"At ≥ 300 mg/kg bw/d, pregnant animals fell into ataxia for several hours and there was a dose-related increase.","duration":"developmental","effect":"g/kg bw/d, 2 of the 20 dams died. At ≥ 300 mg/kg bw/d, pregnant animals fell into ataxia for several hours and there was a dose-related increase. At doses ≥ 300 mg/kg bw/d, dams had decreased body weight gains from GD 9. Effects to foetuses from OPP exposure in utero at the 600 mg/kg bw/d group appeared as an increased (p<0.01) incidence of resorptions and reduced foetal body weights (both sexes). From the results of the study it can be concluded that foetal effects occurred at maternally toxic doses. The maternal NOAEL can be set at 150 mg/kg be/d based on decreased body weight gain and occurrence of ataxia from 300 mg/kg bw/d. The foetal (developmental) NOAEL can be set at 600 mg/kg bw/d based on reduced foetal body weight and an increased incidence of resorptions. Ref.:133; Kwock and Silva (2013) Mice The developmental toxicity of OPP (from Tokyo Kasei Ltd., Lot FB 103) and SOPP (from Dow, Lot MM0144) has been investigated in mice. No information on guideline adherence or GLP is available. In the study with OPP, four groups","endpoint":"developmental toxicity","ingredient":"codes.................................... 9","loael_value":"","noael_unit":"mg/kg","noael_value":"150","page":36,"route":"","species":"mouse","study_id":"sccs_o_177_noael_015"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 600 mg/kg bw/d mouse oral developmental developmental toxicity SOURCE_SUBDIR=sccs_o_177; REPORT_TITLE=OPINION ON o-Phenylphenol, Sodium o-phenylphenate and Potassium o-phenylphenate; OPINION_NUMBER=SCCS/1555/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=15 December 2015; VALUE_TEXT=600; DOSE=At doses ≥ 300 mg/kg bw/d, dams had decreased body weight gains from GD 9.; EFFECT=. At doses ≥ 300 mg/kg bw/d, dams had decreased body weight gains from GD 9. Effects to foetuses from OPP exposure in utero at the 600 mg/kg bw/d group appeared as an increased (p<0.01) incidence of resorptions and reduced foetal body weights (both sexes). From the results of the study it can be concluded that foetal effects occurred at maternally toxic doses. The maternal NOAEL can be set at 150 mg/kg be/d based on decreased body weight gain and occurrence of ataxia from 300 mg/kg bw/d. The foetal (developmental) NOAEL can be set at 600 mg/kg bw/d based on reduced foetal body weight and an increased incidence of resorptions. Ref.:133; Kwock and Silva (2013) Mice The developmental toxicity of OPP (from Tokyo Kasei Ltd., Lot FB 103) and SOPP (from Dow, Lot MM0144) has been investigated in mice. No information on guideline adherence or GLP is available. In the study with OPP, four groups of Jcl:ICR mice considered pregnant (21 animals/dose) received gavage dosages of 0, 1450, 1740, and 2100 mg/kg bw/d OPP in olive oil from GD 7 t; CITATION=Ref.:133; CITATION_NUMBERS=[133]; REFERENCE=Ref.:133; DETAILS_JSON={"cas_number":"90-43-7","citation":"Ref.:133","dose":"At doses ≥ 300 mg/kg bw/d, dams had decreased body weight gains from GD 9.","duration":"developmental","effect":". At doses ≥ 300 mg/kg bw/d, dams had decreased body weight gains from GD 9. Effects to foetuses from OPP exposure in utero at the 600 mg/kg bw/d group appeared as an increased (p<0.01) incidence of resorptions and reduced foetal body weights (both sexes). From the results of the study it can be concluded that foetal effects occurred at maternally toxic doses. The maternal NOAEL can be set at 150 mg/kg be/d based on decreased body weight gain and occurrence of ataxia from 300 mg/kg bw/d. The foetal (developmental) NOAEL can be set at 600 mg/kg bw/d based on reduced foetal body weight and an increased incidence of resorptions. Ref.:133; Kwock and Silva (2013) Mice The developmental toxicity of OPP (from Tokyo Kasei Ltd., Lot FB 103) and SOPP (from Dow, Lot MM0144) has been investigated in mice. No information on guideline adherence or GLP is available. In the study with OPP, four groups of Jcl:ICR mice considered pregnant (21 animals/dose) received gavage dosages of 0, 1450, 1740, and 2100 mg/kg bw/d OPP in olive oil from GD 7 t","endpoint":"developmental toxicity","ingredient":"codes.................................... 9","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"600","page":36,"route":"oral","species":"mouse","study_id":"sccs_o_177_noael_016"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 25 mg/kg bw/d rat - Developmental developmental toxicity SOURCE_SUBDIR=sccs_o_177; REPORT_TITLE=OPINION ON o-Phenylphenol, Sodium o-phenylphenate and Potassium o-phenylphenate; OPINION_NUMBER=SCCS/1555/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=15 December 2015; VALUE_TEXT=25; DOSE=NOAELs for systemic effects of 35 and 100 mg/kg bw/d were derived from the two studies based on morphologic findings in kidneys and urinary bladder.; LOAEL_VALUE=1450 mg/kg bw/d; EFFECT=city or teratogenic effects in both studies. NOAELs for systemic effects of 35 and 100 mg/kg bw/d were derived from the two studies based on morphologic findings in kidneys and urinary bladder. Developmental toxicity of OPP has been investigated in rabbits, rats and mice and there is a report on developmental toxicity of SOPP in mice. No adverse effects of OPP on foetuses of rabbits were observed, however, there were increased incidences of resorptions independent from maternal toxicity, leading to a developmental NOAEL of 25 mg/kg bw/d. An increased incidence of resorption was also reported from developmental toxicity studies performed with OPP in rats. The lowest maternal NOAEL of OPP identified in rats was 100 mg/kg bw whereas the lowest NOAEL for development identified in rats was 300 mg/kg bw/d. In mice treated with comparably high doses of OPP, maternal and developmental effects were observed at all concentrations tested and an LOAEL of 1450 mg/kg bw/d was identified. In mice treated with SOPP, developmental effects (reduce; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"NOAELs for systemic effects of 35 and 100 mg/kg bw/d were derived from the two studies based on morphologic findings in kidneys and urinary bladder.","duration":"Developmental","effect":"city or teratogenic effects in both studies. NOAELs for systemic effects of 35 and 100 mg/kg bw/d were derived from the two studies based on morphologic findings in kidneys and urinary bladder. Developmental toxicity of OPP has been investigated in rabbits, rats and mice and there is a report on developmental toxicity of SOPP in mice. No adverse effects of OPP on foetuses of rabbits were observed, however, there were increased incidences of resorptions independent from maternal toxicity, leading to a developmental NOAEL of 25 mg/kg bw/d. An increased incidence of resorption was also reported from developmental toxicity studies performed with OPP in rats. The lowest maternal NOAEL of OPP identified in rats was 100 mg/kg bw whereas the lowest NOAEL for development identified in rats was 300 mg/kg bw/d. In mice treated with comparably high doses of OPP, maternal and developmental effects were observed at all concentrations tested and an LOAEL of 1450 mg/kg bw/d was identified. In mice treated with SOPP, developmental effects (reduce","endpoint":"developmental toxicity","ingredient":"codes.................................... 9","loael_value":"1450 mg/kg bw/d","noael_unit":"mg/kg bw/d","noael_value":"25","page":37,"route":"","species":"rat","study_id":"sccs_o_177_noael_017"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 100 mg/kg bw rat - Developmental developmental toxicity SOURCE_SUBDIR=sccs_o_177; REPORT_TITLE=OPINION ON o-Phenylphenol, Sodium o-phenylphenate and Potassium o-phenylphenate; OPINION_NUMBER=SCCS/1555/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=15 December 2015; VALUE_TEXT=100; DOSE=No adverse effects of OPP on foetuses of rabbits were observed, however, there were increased incidences of resorptions independent from maternal toxicity, leading to a developmental NOAEL of 25 mg/kg bw/d.; LOAEL_VALUE=1450 mg/kg bw/d; EFFECT=n kidneys and urinary bladder. Developmental toxicity of OPP has been investigated in rabbits, rats and mice and there is a report on developmental toxicity of SOPP in mice. No adverse effects of OPP on foetuses of rabbits were observed, however, there were increased incidences of resorptions independent from maternal toxicity, leading to a developmental NOAEL of 25 mg/kg bw/d. An increased incidence of resorption was also reported from developmental toxicity studies performed with OPP in rats. The lowest maternal NOAEL of OPP identified in rats was 100 mg/kg bw whereas the lowest NOAEL for development identified in rats was 300 mg/kg bw/d. In mice treated with comparably high doses of OPP, maternal and developmental effects were observed at all concentrations tested and an LOAEL of 1450 mg/kg bw/d was identified. In mice treated with SOPP, developmental effects (reduced foetal weight and increased incidence of cleft palate) could be observed at the lowest dose tested (100 mg/kg bw/d). As a summary, whereas OPP does not adversely; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"No adverse effects of OPP on foetuses of rabbits were observed, however, there were increased incidences of resorptions independent from maternal toxicity, leading to a developmental NOAEL of 25 mg/kg bw/d.","duration":"Developmental","effect":"n kidneys and urinary bladder. Developmental toxicity of OPP has been investigated in rabbits, rats and mice and there is a report on developmental toxicity of SOPP in mice. No adverse effects of OPP on foetuses of rabbits were observed, however, there were increased incidences of resorptions independent from maternal toxicity, leading to a developmental NOAEL of 25 mg/kg bw/d. An increased incidence of resorption was also reported from developmental toxicity studies performed with OPP in rats. The lowest maternal NOAEL of OPP identified in rats was 100 mg/kg bw whereas the lowest NOAEL for development identified in rats was 300 mg/kg bw/d. In mice treated with comparably high doses of OPP, maternal and developmental effects were observed at all concentrations tested and an LOAEL of 1450 mg/kg bw/d was identified. In mice treated with SOPP, developmental effects (reduced foetal weight and increased incidence of cleft palate) could be observed at the lowest dose tested (100 mg/kg bw/d). As a summary, whereas OPP does not adversely","endpoint":"developmental toxicity","ingredient":"codes.................................... 9","loael_value":"1450 mg/kg bw/d","noael_unit":"mg/kg bw","noael_value":"100","page":37,"route":"","species":"rat","study_id":"sccs_o_177_noael_018"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 25 mg/kg bw/d - - developmental developmental toxicity SOURCE_SUBDIR=sccs_o_177; REPORT_TITLE=OPINION ON o-Phenylphenol, Sodium o-phenylphenate and Potassium o-phenylphenate; OPINION_NUMBER=SCCS/1555/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=15 December 2015; VALUE_TEXT=25; DOSE=The lowest developmental NOAEL identified was 25 mg/kg bw/d, which will be taken for MOS calculation.; EFFECT=SCCS/1555/15 Revision of the Opinion on o-Phenylphenol, Sodium o-phenylphenate and Potassium o-phenylphenate ____________________________________________________________________________________________________________________ 38 organs, increased incidence of resorptions can be considered as a developmental effect of OPP and SOPP. The lowest developmental NOAEL identified was 25 mg/kg bw/d, which will be taken for MOS calculation. 3.3.9 Toxicokinetics 3.3.9.1 Toxicokinetics in laboratory animals The toxicokinetics of OPP has been investigated in vitro and in vivo in different species. The principal metabolic pathways are given in figure 1. Figure 1: Overview on the metabolic pathways of OPP in different mammalian species (ref. California Environmental Protection Agency, April 2007. Ortho-Phenylphenol (OPP) and Sodium Ortho-Phenylphenate (SOPP), Risk Characteriza; CITATION=(ref. California Environmental Protection Agency, April 2007. Ortho-Phenylphenol (OPP); CITATION_NUMBERS=[2007]; REFERENCE=(ref. California Environmental Protection Agency, April 2007. Ortho-Phenylphenol (OPP); DETAILS_JSON={"cas_number":"90-43-7","citation":"(ref. California Environmental Protection Agency, April 2007. Ortho-Phenylphenol (OPP)","dose":"The lowest developmental NOAEL identified was 25 mg/kg bw/d, which will be taken for MOS calculation.","duration":"developmental","effect":"SCCS/1555/15 Revision of the Opinion on o-Phenylphenol, Sodium o-phenylphenate and Potassium o-phenylphenate ____________________________________________________________________________________________________________________ 38 organs, increased incidence of resorptions can be considered as a developmental effect of OPP and SOPP. The lowest developmental NOAEL identified was 25 mg/kg bw/d, which will be taken for MOS calculation. 3.3.9 Toxicokinetics 3.3.9.1 Toxicokinetics in laboratory animals The toxicokinetics of OPP has been investigated in vitro and in vivo in different species. The principal metabolic pathways are given in figure 1. Figure 1: Overview on the metabolic pathways of OPP in different mammalian species (ref. California Environmental Protection Agency, April 2007. Ortho-Phenylphenol (OPP) and Sodium Ortho-Phenylphenate (SOPP), Risk Characteriza","endpoint":"developmental toxicity","ingredient":"codes.................................... 9","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"25","page":38,"route":"","species":"","study_id":"sccs_o_177_noael_020"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 25 mg/kg bw/d rabbit - developmental developmental toxicity SOURCE_SUBDIR=sccs_o_177; REPORT_TITLE=OPINION ON o-Phenylphenol, Sodium o-phenylphenate and Potassium o-phenylphenate; OPINION_NUMBER=SCCS/1555/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=15 December 2015; VALUE_TEXT=25; DOSE=SCCS/1555/15 Revision of the Opinion on o-Phenylphenol, Sodium o-phenylphenate and Potassium o-phenylphenate ____________________________________________________________________________________________________________________ 47 An even lower NOAEL of 25 mg/kg bw/d for OPP was obtained from a developmental toxicity study in rabbits based on stat...; EFFECT=SCCS/1555/15 Revision of the Opinion on o-Phenylphenol, Sodium o-phenylphenate and Potassium o-phenylphenate ____________________________________________________________________________________________________________________ 47 An even lower NOAEL of 25 mg/kg bw/d for OPP was obtained from a developmental toxicity study in rabbits based on statistically significant increases in resorptions (Ref. 319 and Kwock and Silva, 2013). An NOAEL of 25 mg/kg bw/d would therefore also be protective for OPP-induced changes in the urinary tract/urinary bladder. 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Calculation only for OPP as only the database for OPP is sufficient to assume a threshold. 1. Leave-on produ; CITATION=(Ref. 319 and Kwock and Silva, 2013); CITATION_NUMBERS=[319,2013]; REFERENCE=(Ref. 319 and Kwock and Silva, 2013); DETAILS_JSON={"cas_number":"90-43-7","citation":"(Ref. 319 and Kwock and Silva, 2013)","dose":"SCCS/1555/15 Revision of the Opinion on o-Phenylphenol, Sodium o-phenylphenate and Potassium o-phenylphenate ____________________________________________________________________________________________________________________ 47 An even lower NOAEL of 25 mg/kg bw/d for OPP was obtained from a developmental toxicity study in rabbits based on stat...","duration":"developmental","effect":"SCCS/1555/15 Revision of the Opinion on o-Phenylphenol, Sodium o-phenylphenate and Potassium o-phenylphenate ____________________________________________________________________________________________________________________ 47 An even lower NOAEL of 25 mg/kg bw/d for OPP was obtained from a developmental toxicity study in rabbits based on statistically significant increases in resorptions (Ref. 319 and Kwock and Silva, 2013). An NOAEL of 25 mg/kg bw/d would therefore also be protective for OPP-induced changes in the urinary tract/urinary bladder. 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Calculation only for OPP as only the database for OPP is sufficient to assume a threshold. 1. Leave-on produ","endpoint":"developmental toxicity","ingredient":"codes.................................... 9","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"25","page":47,"route":"","species":"rabbit","study_id":"sccs_o_177_noael_023"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity =25 mg/kg bw/d rabbit oral developmental developmental toxicity SOURCE_SUBDIR=sccs_o_177; REPORT_TITLE=OPINION ON o-Phenylphenol, Sodium o-phenylphenate and Potassium o-phenylphenate; OPINION_NUMBER=SCCS/1555/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=15 December 2015; VALUE_TEXT== 25; DOSE=ucts An aggregate value of 17.4 g/d (269 mg/kg bw/d) for the amount of cosmetics applied daily is taken for MoS calculation according to the SCCS's Notes of Guidance 8th revision.; EFFECT=ucts An aggregate value of 17.4 g/d (269 mg/kg bw/d) for the amount of cosmetics applied daily is taken for MoS calculation according to the SCCS's Notes of Guidance 8th revision. Absorption through the skin DAp (%) = 45 % Amount of cosmetic product applied daily A (g/d) = 17.4 g/d Concentration of ingredient in finished product C (%) = 0.2 % Typical body weight of human = 60 kg Systemic exposure dose (SED) = A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60 = 0.261 mg/kg bw/d No adverse observed effect level NOAEL = 25 mg/kg bw/d (oral developmental toxicity study, rabbit) No adjustment, 100 % oral absorption MOS NOAEL/SED = 96 2. Rinse-off products An aggregate value of 0.54 g/d (8.3 mg/kg bw/d) for the amount of cosmetics applied daily is taken for MoS calculation, according to the SCCS's Notes of Guidance 8th revision. Absorption through the skin DAp (%) = 45 % Amount of cosmetic product applied daily A (g/d) = 0.54 g/d Concentration of ingredient in finished product C (%) = 0.2 % Typical body weight of human =; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"ucts An aggregate value of 17.4 g/d (269 mg/kg bw/d) for the amount of cosmetics applied daily is taken for MoS calculation according to the SCCS's Notes of Guidance 8th revision.","duration":"developmental","effect":"ucts An aggregate value of 17.4 g/d (269 mg/kg bw/d) for the amount of cosmetics applied daily is taken for MoS calculation according to the SCCS's Notes of Guidance 8th revision. Absorption through the skin DAp (%) = 45 % Amount of cosmetic product applied daily A (g/d) = 17.4 g/d Concentration of ingredient in finished product C (%) = 0.2 % Typical body weight of human = 60 kg Systemic exposure dose (SED) = A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60 = 0.261 mg/kg bw/d No adverse observed effect level NOAEL = 25 mg/kg bw/d (oral developmental toxicity study, rabbit) No adjustment, 100 % oral absorption MOS NOAEL/SED = 96 2. Rinse-off products An aggregate value of 0.54 g/d (8.3 mg/kg bw/d) for the amount of cosmetics applied daily is taken for MoS calculation, according to the SCCS's Notes of Guidance 8th revision. Absorption through the skin DAp (%) = 45 % Amount of cosmetic product applied daily A (g/d) = 0.54 g/d Concentration of ingredient in finished product C (%) = 0.2 % Typical body weight of human =","endpoint":"developmental toxicity","ingredient":"codes.................................... 9","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 25","page":47,"route":"oral","species":"rabbit","study_id":"sccs_o_177_noael_024"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 100 % rabbit oral developmental developmental toxicity SOURCE_SUBDIR=sccs_o_177; REPORT_TITLE=OPINION ON o-Phenylphenol, Sodium o-phenylphenate and Potassium o-phenylphenate; OPINION_NUMBER=SCCS/1555/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=15 December 2015; VALUE_TEXT=100; DOSE=Absorption through the skin DAp (%) = 45 % Amount of cosmetic product applied daily A (g/d) = 17.4 g/d Concentration of ingredient in finished product C (%) = 0.2 % Typical body weight of human = 60 kg Systemic exposure dose (SED) = A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60 = 0.261 mg/kg bw/d No adverse observed effect level NOAEL = 25 m...; EFFECT=MoS calculation according to the SCCS's Notes of Guidance 8th revision. Absorption through the skin DAp (%) = 45 % Amount of cosmetic product applied daily A (g/d) = 17.4 g/d Concentration of ingredient in finished product C (%) = 0.2 % Typical body weight of human = 60 kg Systemic exposure dose (SED) = A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60 = 0.261 mg/kg bw/d No adverse observed effect level NOAEL = 25 mg/kg bw/d (oral developmental toxicity study, rabbit) No adjustment, 100 % oral absorption MOS NOAEL/SED = 96 2. Rinse-off products An aggregate value of 0.54 g/d (8.3 mg/kg bw/d) for the amount of cosmetics applied daily is taken for MoS calculation, according to the SCCS's Notes of Guidance 8th revision. Absorption through the skin DAp (%) = 45 % Amount of cosmetic product applied daily A (g/d) = 0.54 g/d Concentration of ingredient in finished product C (%) = 0.2 % Typical body weight of human = 60 kg Systemic exposure dose (SED) = A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60 = 0.0081 mg/kg bw/d No; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"Absorption through the skin DAp (%) = 45 % Amount of cosmetic product applied daily A (g/d) = 17.4 g/d Concentration of ingredient in finished product C (%) = 0.2 % Typical body weight of human = 60 kg Systemic exposure dose (SED) = A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60 = 0.261 mg/kg bw/d No adverse observed effect level NOAEL = 25 m...","duration":"developmental","effect":"MoS calculation according to the SCCS's Notes of Guidance 8th revision. Absorption through the skin DAp (%) = 45 % Amount of cosmetic product applied daily A (g/d) = 17.4 g/d Concentration of ingredient in finished product C (%) = 0.2 % Typical body weight of human = 60 kg Systemic exposure dose (SED) = A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60 = 0.261 mg/kg bw/d No adverse observed effect level NOAEL = 25 mg/kg bw/d (oral developmental toxicity study, rabbit) No adjustment, 100 % oral absorption MOS NOAEL/SED = 96 2. Rinse-off products An aggregate value of 0.54 g/d (8.3 mg/kg bw/d) for the amount of cosmetics applied daily is taken for MoS calculation, according to the SCCS's Notes of Guidance 8th revision. Absorption through the skin DAp (%) = 45 % Amount of cosmetic product applied daily A (g/d) = 0.54 g/d Concentration of ingredient in finished product C (%) = 0.2 % Typical body weight of human = 60 kg Systemic exposure dose (SED) = A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60 = 0.0081 mg/kg bw/d No","endpoint":"developmental toxicity","ingredient":"codes.................................... 9","loael_value":"","noael_unit":"%","noael_value":"100","page":47,"route":"oral","species":"rabbit","study_id":"sccs_o_177_noael_025"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity =25 mg/kg bw/d rabbit oral developmental developmental toxicity SOURCE_SUBDIR=sccs_o_177; REPORT_TITLE=OPINION ON o-Phenylphenol, Sodium o-phenylphenate and Potassium o-phenylphenate; OPINION_NUMBER=SCCS/1555/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=15 December 2015; VALUE_TEXT== 25; DOSE=ts An aggregate value of 0.54 g/d (8.3 mg/kg bw/d) for the amount of cosmetics applied daily is taken for MoS calculation, according to the SCCS's Notes of Guidance 8th revision.; EFFECT=ts An aggregate value of 0.54 g/d (8.3 mg/kg bw/d) for the amount of cosmetics applied daily is taken for MoS calculation, according to the SCCS's Notes of Guidance 8th revision. Absorption through the skin DAp (%) = 45 % Amount of cosmetic product applied daily A (g/d) = 0.54 g/d Concentration of ingredient in finished product C (%) = 0.2 % Typical body weight of human = 60 kg Systemic exposure dose (SED) = A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60 = 0.0081 mg/kg bw/d No adverse observed effect level NOAEL = 25 mg/kg bw/d (oral developmental toxicity study, rabbit); CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"ts An aggregate value of 0.54 g/d (8.3 mg/kg bw/d) for the amount of cosmetics applied daily is taken for MoS calculation, according to the SCCS's Notes of Guidance 8th revision.","duration":"developmental","effect":"ts An aggregate value of 0.54 g/d (8.3 mg/kg bw/d) for the amount of cosmetics applied daily is taken for MoS calculation, according to the SCCS's Notes of Guidance 8th revision. Absorption through the skin DAp (%) = 45 % Amount of cosmetic product applied daily A (g/d) = 0.54 g/d Concentration of ingredient in finished product C (%) = 0.2 % Typical body weight of human = 60 kg Systemic exposure dose (SED) = A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60 = 0.0081 mg/kg bw/d No adverse observed effect level NOAEL = 25 mg/kg bw/d (oral developmental toxicity study, rabbit)","endpoint":"developmental toxicity","ingredient":"codes.................................... 9","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 25","page":47,"route":"oral","species":"rabbit","study_id":"sccs_o_177_noael_026"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 25 mg/kg bw/d rat - Developmental developmental toxicity SOURCE_SUBDIR=sccs_o_177; REPORT_TITLE=OPINION ON o-Phenylphenol, Sodium o-phenylphenate and Potassium o-phenylphenate; OPINION_NUMBER=SCCS/1555/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=15 December 2015; VALUE_TEXT=25; DOSE=NOAELs for systemic effects of 35 and 100 mg/kg bw/d were derived from the two studies based on morphologic findings in kidneys and urinary bladder.; LOAEL_VALUE=1450 mg/kg bw/d; EFFECT=city or teratogenic effects in both studies. NOAELs for systemic effects of 35 and 100 mg/kg bw/d were derived from the two studies based on morphologic findings in kidneys and urinary bladder. Developmental toxicity of OPP has been investigated in rabbits, rats and mice and there is a report on developmental toxicity of SOPP in mice. No adverse effects of OPP on foetuses of rabbits were observed, however, there were increased incidences of resorptions independent from maternal toxicity, leading to a developmental NOAEL of 25 mg/kg bw/d. An increased incidence of resorption was also reported from developmental toxicity studies performed with OPP in rats. The lowest maternal NOAEL of OPP identified in rats was 100 mg/kg bw, whereas the lowest NOAEL for development identified in rats was 300 mg/kg bw/d. In mice treated with comparably high doses of OPP, maternal and developmental effects were observed at all concentrations tested and an LOAEL of 1450 mg/kg bw/d was identified. In mice treated with SOPP, developmental effects (reduc; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"NOAELs for systemic effects of 35 and 100 mg/kg bw/d were derived from the two studies based on morphologic findings in kidneys and urinary bladder.","duration":"Developmental","effect":"city or teratogenic effects in both studies. NOAELs for systemic effects of 35 and 100 mg/kg bw/d were derived from the two studies based on morphologic findings in kidneys and urinary bladder. Developmental toxicity of OPP has been investigated in rabbits, rats and mice and there is a report on developmental toxicity of SOPP in mice. No adverse effects of OPP on foetuses of rabbits were observed, however, there were increased incidences of resorptions independent from maternal toxicity, leading to a developmental NOAEL of 25 mg/kg bw/d. An increased incidence of resorption was also reported from developmental toxicity studies performed with OPP in rats. The lowest maternal NOAEL of OPP identified in rats was 100 mg/kg bw, whereas the lowest NOAEL for development identified in rats was 300 mg/kg bw/d. In mice treated with comparably high doses of OPP, maternal and developmental effects were observed at all concentrations tested and an LOAEL of 1450 mg/kg bw/d was identified. In mice treated with SOPP, developmental effects (reduc","endpoint":"developmental toxicity","ingredient":"codes.................................... 9","loael_value":"1450 mg/kg bw/d","noael_unit":"mg/kg bw/d","noael_value":"25","page":50,"route":"","species":"rat","study_id":"sccs_o_177_noael_028"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 100 mg/kg bw rat - Developmental developmental toxicity SOURCE_SUBDIR=sccs_o_177; REPORT_TITLE=OPINION ON o-Phenylphenol, Sodium o-phenylphenate and Potassium o-phenylphenate; OPINION_NUMBER=SCCS/1555/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=15 December 2015; VALUE_TEXT=100; DOSE=No adverse effects of OPP on foetuses of rabbits were observed, however, there were increased incidences of resorptions independent from maternal toxicity, leading to a developmental NOAEL of 25 mg/kg bw/d.; LOAEL_VALUE=1450 mg/kg bw/d; EFFECT=n kidneys and urinary bladder. Developmental toxicity of OPP has been investigated in rabbits, rats and mice and there is a report on developmental toxicity of SOPP in mice. No adverse effects of OPP on foetuses of rabbits were observed, however, there were increased incidences of resorptions independent from maternal toxicity, leading to a developmental NOAEL of 25 mg/kg bw/d. An increased incidence of resorption was also reported from developmental toxicity studies performed with OPP in rats. The lowest maternal NOAEL of OPP identified in rats was 100 mg/kg bw, whereas the lowest NOAEL for development identified in rats was 300 mg/kg bw/d. In mice treated with comparably high doses of OPP, maternal and developmental effects were observed at all concentrations tested and an LOAEL of 1450 mg/kg bw/d was identified. In mice treated with SOPP, developmental effects (reduced foetal weight and increased incidence of cleft palate) could be observed at the lowest dose tested (100 mg/kg bw/d). As a summary, whereas OPP does not adversel; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"No adverse effects of OPP on foetuses of rabbits were observed, however, there were increased incidences of resorptions independent from maternal toxicity, leading to a developmental NOAEL of 25 mg/kg bw/d.","duration":"Developmental","effect":"n kidneys and urinary bladder. Developmental toxicity of OPP has been investigated in rabbits, rats and mice and there is a report on developmental toxicity of SOPP in mice. No adverse effects of OPP on foetuses of rabbits were observed, however, there were increased incidences of resorptions independent from maternal toxicity, leading to a developmental NOAEL of 25 mg/kg bw/d. An increased incidence of resorption was also reported from developmental toxicity studies performed with OPP in rats. The lowest maternal NOAEL of OPP identified in rats was 100 mg/kg bw, whereas the lowest NOAEL for development identified in rats was 300 mg/kg bw/d. In mice treated with comparably high doses of OPP, maternal and developmental effects were observed at all concentrations tested and an LOAEL of 1450 mg/kg bw/d was identified. In mice treated with SOPP, developmental effects (reduced foetal weight and increased incidence of cleft palate) could be observed at the lowest dose tested (100 mg/kg bw/d). As a summary, whereas OPP does not adversel","endpoint":"developmental toxicity","ingredient":"codes.................................... 9","loael_value":"1450 mg/kg bw/d","noael_unit":"mg/kg bw","noael_value":"100","page":50,"route":"","species":"rat","study_id":"sccs_o_177_noael_029"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 25 mg/kg bw/day rat - developmental developmental toxicity SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=25; DOSE=As a result, the LOAEL was established at 1450 mg/kg bw/day.; LOAEL_VALUE=1450 mg/kg bw/day; EFFECT=l effects were observed at all tested doses. As a result, the LOAEL was established at 1450 mg/kg bw/day. Similarly, an increased incidence of resorptions was reported in rat developmental toxicity studies with OPP. The lowest NOAELs identified for maternal and developmental effects were 100 and 300 mg/kg bw/day, respectively. In rabbits, no adverse effects on foetuses were observed. However, increased incidences of resorptions were noted, and these appeared to be independent of maternal toxicity. As a result, the NOAEL for developmental toxicity was established at 25 mg/kg bw/day. In the mouse study with SOPP, developmental effects, such as reduced foetal weight and an increased incidence of cleft palate, were observed even at the lowest dose tested (100 mg/kg bw/day). The only developmental toxicity study with SOPP, is not considered to be useful in safety assessment due to design and reporting limitations. However, it did suggest SOPP's potential interference with rodent development. In summary, while OPP did not adversely aff; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"As a result, the LOAEL was established at 1450 mg/kg bw/day.","duration":"developmental","effect":"l effects were observed at all tested doses. As a result, the LOAEL was established at 1450 mg/kg bw/day. Similarly, an increased incidence of resorptions was reported in rat developmental toxicity studies with OPP. The lowest NOAELs identified for maternal and developmental effects were 100 and 300 mg/kg bw/day, respectively. In rabbits, no adverse effects on foetuses were observed. However, increased incidences of resorptions were noted, and these appeared to be independent of maternal toxicity. As a result, the NOAEL for developmental toxicity was established at 25 mg/kg bw/day. In the mouse study with SOPP, developmental effects, such as reduced foetal weight and an increased incidence of cleft palate, were observed even at the lowest dose tested (100 mg/kg bw/day). The only developmental toxicity study with SOPP, is not considered to be useful in safety assessment due to design and reporting limitations. However, it did suggest SOPP's potential interference with rodent development. In summary, while OPP did not adversely aff","endpoint":"developmental toxicity","ingredient":"s, toys, textiles, clothing,","loael_value":"1450 mg/kg bw/day","noael_unit":"mg/kg bw/day","noael_value":"25","page":31,"route":"","species":"rat","study_id":"sccs_o_291_noael_001"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 22.4 mg/kg bw/day rat oral 104-week developmental toxicity SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=22.4; DOSE=ion pathways are saturated The SCCS has noted the NOAELs proposed by the Applicant for OPP and SOPP for systemic toxicity and carcinogenicity (for OPP: lowest NOAEL established at 39 and 49 mg/kg bw/day in males and females, respectively; for SOPP, an oral LOAEL of 224 mg/kg bw/day from a 104-week carcinogenicity study in rats has been considere...; LOAEL_VALUE=224 mg/kg bw/day; EFFECT=ion pathways are saturated The SCCS has noted the NOAELs proposed by the Applicant for OPP and SOPP for systemic toxicity and carcinogenicity (for OPP: lowest NOAEL established at 39 and 49 mg/kg bw/day in males and females, respectively; for SOPP, an oral LOAEL of 224 mg/kg bw/day from a 104-week carcinogenicity study in rats has been considered as most appropriate and conservative value for PoD derivation. The Applicant applied a composite uncertainty factor of 10 to account for the extrapolation from LOAEL to NOAEL and study data quality resulting in a corrected PoD of 22.4 mg/kg bw/day. The SCCS, however, stated in SCCS/1555/15 that the 104-week carcinogenicity study in rats performed with SOPP was not performed according to currently accepted standards but that it can be used as supporting information. Therefore, the SCCS will use the NOAEL of 25 mg/kg bw/d obtained from a developmental toxicity study for MoS calculation of both OPP and SOPP. This value is supported by the Applicant’s corrected PoD for SOPP of 22.4 mg/kg; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"ion pathways are saturated The SCCS has noted the NOAELs proposed by the Applicant for OPP and SOPP for systemic toxicity and carcinogenicity (for OPP: lowest NOAEL established at 39 and 49 mg/kg bw/day in males and females, respectively; for SOPP, an oral LOAEL of 224 mg/kg bw/day from a 104-week carcinogenicity study in rats has been considere...","duration":"104-week","effect":"ion pathways are saturated The SCCS has noted the NOAELs proposed by the Applicant for OPP and SOPP for systemic toxicity and carcinogenicity (for OPP: lowest NOAEL established at 39 and 49 mg/kg bw/day in males and females, respectively; for SOPP, an oral LOAEL of 224 mg/kg bw/day from a 104-week carcinogenicity study in rats has been considered as most appropriate and conservative value for PoD derivation. The Applicant applied a composite uncertainty factor of 10 to account for the extrapolation from LOAEL to NOAEL and study data quality resulting in a corrected PoD of 22.4 mg/kg bw/day. The SCCS, however, stated in SCCS/1555/15 that the 104-week carcinogenicity study in rats performed with SOPP was not performed according to currently accepted standards but that it can be used as supporting information. Therefore, the SCCS will use the NOAEL of 25 mg/kg bw/d obtained from a developmental toxicity study for MoS calculation of both OPP and SOPP. This value is supported by the Applicant’s corrected PoD for SOPP of 22.4 mg/kg","endpoint":"developmental toxicity","ingredient":"s, toys, textiles, clothing,","loael_value":"224 mg/kg bw/day","noael_unit":"mg/kg bw/day","noael_value":"22.4","page":37,"route":"oral","species":"rat","study_id":"sccs_o_291_noael_010"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 25 mg/kg bw/d rat - 104-week developmental toxicity SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=25; DOSE=The Applicant applied a composite uncertainty factor of 10 to account for the extrapolation from LOAEL to NOAEL and study data quality resulting in a corrected PoD of 22.4 mg/kg bw/day.; LOAEL_VALUE=22.4 mg/kg bw/day; EFFECT=been considered as most appropriate and conservative value for PoD derivation. The Applicant applied a composite uncertainty factor of 10 to account for the extrapolation from LOAEL to NOAEL and study data quality resulting in a corrected PoD of 22.4 mg/kg bw/day. The SCCS, however, stated in SCCS/1555/15 that the 104-week carcinogenicity study in rats performed with SOPP was not performed according to currently accepted standards but that it can be used as supporting information. Therefore, the SCCS will use the NOAEL of 25 mg/kg bw/d obtained from a developmental toxicity study for MoS calculation of both OPP and SOPP. This value is supported by the Applicant’s corrected PoD for SOPP of 22.4 mg/kg bw/d and by the SCCS assumption (see section 3.2.1) that any SOPP entering systemic circulation will not be absorbed into the cells more than OPP, and will be cleared more quickly via urine than OPP. 3.4.8 Photo-induced toxicity According to the Applicant A photo irritation study is available with BALB/c 3T3 cell line for OPP. The; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"The Applicant applied a composite uncertainty factor of 10 to account for the extrapolation from LOAEL to NOAEL and study data quality resulting in a corrected PoD of 22.4 mg/kg bw/day.","duration":"104-week","effect":"been considered as most appropriate and conservative value for PoD derivation. The Applicant applied a composite uncertainty factor of 10 to account for the extrapolation from LOAEL to NOAEL and study data quality resulting in a corrected PoD of 22.4 mg/kg bw/day. The SCCS, however, stated in SCCS/1555/15 that the 104-week carcinogenicity study in rats performed with SOPP was not performed according to currently accepted standards but that it can be used as supporting information. Therefore, the SCCS will use the NOAEL of 25 mg/kg bw/d obtained from a developmental toxicity study for MoS calculation of both OPP and SOPP. This value is supported by the Applicant’s corrected PoD for SOPP of 22.4 mg/kg bw/d and by the SCCS assumption (see section 3.2.1) that any SOPP entering systemic circulation will not be absorbed into the cells more than OPP, and will be cleared more quickly via urine than OPP. 3.4.8 Photo-induced toxicity According to the Applicant A photo irritation study is available with BALB/c 3T3 cell line for OPP. The","endpoint":"developmental toxicity","ingredient":"s, toys, textiles, clothing,","loael_value":"22.4 mg/kg bw/day","noael_unit":"mg/kg bw/d","noael_value":"25","page":37,"route":"","species":"rat","study_id":"sccs_o_291_noael_011"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity =25 mg/kg bw/d rabbit oral developmental developmental toxicity SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT== 25; DOSE=ts) An aggregate value of 17.4 g/d (269 mg/kg bw/d) for the amount of cosmetics applied daily is taken for MoS calculation according to the SCCS's Notes of Guidance 12th revision.; EFFECT=ts) An aggregate value of 17.4 g/d (269 mg/kg bw/d) for the amount of cosmetics applied daily is taken for MoS calculation according to the SCCS's Notes of Guidance 12th revision. Absorption through the skin DAp (%) = 45 % Amount of cosmetic product applied daily A (g/d) = 14.54 g/d Concentration of ingredient in finished product C (%) = 0.15 % Typical body weight of human = 60 kg Systemic exposure dose (SED) = A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60 = 0.163 mg/kg bw/d No adverse observed effect level NOAEL = 25 mg/kg bw/d (oral developmental toxicity study, rabbit) No adjustment, 100 % oral absorption Margin of Safety adjusted NOAEL/SED = 153 OPP in rinse-off products An aggregate value of 0.54 g/d (8.3 mg/kg bw/d) for the amount of cosmetics applied daily is taken for MoS calculation, according to the SCCS's Notes of Guidance 12th revision. Absorption through the skin DAp (%) = 45 % Amount of cosmetic product applied daily A (g/d) = 0.54 g/d Concentration of ingredient in finished product C (%) = 0.2 % Typica; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"ts) An aggregate value of 17.4 g/d (269 mg/kg bw/d) for the amount of cosmetics applied daily is taken for MoS calculation according to the SCCS's Notes of Guidance 12th revision.","duration":"developmental","effect":"ts) An aggregate value of 17.4 g/d (269 mg/kg bw/d) for the amount of cosmetics applied daily is taken for MoS calculation according to the SCCS's Notes of Guidance 12th revision. Absorption through the skin DAp (%) = 45 % Amount of cosmetic product applied daily A (g/d) = 14.54 g/d Concentration of ingredient in finished product C (%) = 0.15 % Typical body weight of human = 60 kg Systemic exposure dose (SED) = A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60 = 0.163 mg/kg bw/d No adverse observed effect level NOAEL = 25 mg/kg bw/d (oral developmental toxicity study, rabbit) No adjustment, 100 % oral absorption Margin of Safety adjusted NOAEL/SED = 153 OPP in rinse-off products An aggregate value of 0.54 g/d (8.3 mg/kg bw/d) for the amount of cosmetics applied daily is taken for MoS calculation, according to the SCCS's Notes of Guidance 12th revision. Absorption through the skin DAp (%) = 45 % Amount of cosmetic product applied daily A (g/d) = 0.54 g/d Concentration of ingredient in finished product C (%) = 0.2 % Typica","endpoint":"developmental toxicity","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 25","page":41,"route":"oral","species":"rabbit","study_id":"sccs_o_291_noael_012"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 100 % rabbit oral developmental developmental toxicity SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=100; DOSE=Absorption through the skin DAp (%) = 45 % Amount of cosmetic product applied daily A (g/d) = 14.54 g/d Concentration of ingredient in finished product C (%) = 0.15 % Typical body weight of human = 60 kg Systemic exposure dose (SED) = A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60 = 0.163 mg/kg bw/d No adverse observed effect level NOAEL = 25...; EFFECT=ing to the SCCS's Notes of Guidance 12th revision. Absorption through the skin DAp (%) = 45 % Amount of cosmetic product applied daily A (g/d) = 14.54 g/d Concentration of ingredient in finished product C (%) = 0.15 % Typical body weight of human = 60 kg Systemic exposure dose (SED) = A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60 = 0.163 mg/kg bw/d No adverse observed effect level NOAEL = 25 mg/kg bw/d (oral developmental toxicity study, rabbit) No adjustment, 100 % oral absorption Margin of Safety adjusted NOAEL/SED = 153 OPP in rinse-off products An aggregate value of 0.54 g/d (8.3 mg/kg bw/d) for the amount of cosmetics applied daily is taken for MoS calculation, according to the SCCS's Notes of Guidance 12th revision. Absorption through the skin DAp (%) = 45 % Amount of cosmetic product applied daily A (g/d) = 0.54 g/d Concentration of ingredient in finished product C (%) = 0.2 % Typical body weight of human = 60 kg Systemic exposure dose (SED) = A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60 = 0.0081 mg/kg bw; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"Absorption through the skin DAp (%) = 45 % Amount of cosmetic product applied daily A (g/d) = 14.54 g/d Concentration of ingredient in finished product C (%) = 0.15 % Typical body weight of human = 60 kg Systemic exposure dose (SED) = A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60 = 0.163 mg/kg bw/d No adverse observed effect level NOAEL = 25...","duration":"developmental","effect":"ing to the SCCS's Notes of Guidance 12th revision. Absorption through the skin DAp (%) = 45 % Amount of cosmetic product applied daily A (g/d) = 14.54 g/d Concentration of ingredient in finished product C (%) = 0.15 % Typical body weight of human = 60 kg Systemic exposure dose (SED) = A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60 = 0.163 mg/kg bw/d No adverse observed effect level NOAEL = 25 mg/kg bw/d (oral developmental toxicity study, rabbit) No adjustment, 100 % oral absorption Margin of Safety adjusted NOAEL/SED = 153 OPP in rinse-off products An aggregate value of 0.54 g/d (8.3 mg/kg bw/d) for the amount of cosmetics applied daily is taken for MoS calculation, according to the SCCS's Notes of Guidance 12th revision. Absorption through the skin DAp (%) = 45 % Amount of cosmetic product applied daily A (g/d) = 0.54 g/d Concentration of ingredient in finished product C (%) = 0.2 % Typical body weight of human = 60 kg Systemic exposure dose (SED) = A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60 = 0.0081 mg/kg bw","endpoint":"developmental toxicity","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"%","noael_value":"100","page":41,"route":"oral","species":"rabbit","study_id":"sccs_o_291_noael_013"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity =25 mg/kg bw/d rabbit oral developmental developmental toxicity SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT== 25; DOSE=cts An aggregate value of 0.54 g/d (8.3 mg/kg bw/d) for the amount of cosmetics applied daily is taken for MoS calculation, according to the SCCS's Notes of Guidance 12th revision.; EFFECT=cts An aggregate value of 0.54 g/d (8.3 mg/kg bw/d) for the amount of cosmetics applied daily is taken for MoS calculation, according to the SCCS's Notes of Guidance 12th revision. Absorption through the skin DAp (%) = 45 % Amount of cosmetic product applied daily A (g/d) = 0.54 g/d Concentration of ingredient in finished product C (%) = 0.2 % Typical body weight of human = 60 kg Systemic exposure dose (SED) = A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60 = 0.0081 mg/kg bw/d No adverse observed effect level NOAEL = 25 mg/kg bw/d (oral developmental toxicity study, rabbit) No adjustment, 100 % oral absorption Margin of Safety NOAEL/SED = 3100; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"cts An aggregate value of 0.54 g/d (8.3 mg/kg bw/d) for the amount of cosmetics applied daily is taken for MoS calculation, according to the SCCS's Notes of Guidance 12th revision.","duration":"developmental","effect":"cts An aggregate value of 0.54 g/d (8.3 mg/kg bw/d) for the amount of cosmetics applied daily is taken for MoS calculation, according to the SCCS's Notes of Guidance 12th revision. Absorption through the skin DAp (%) = 45 % Amount of cosmetic product applied daily A (g/d) = 0.54 g/d Concentration of ingredient in finished product C (%) = 0.2 % Typical body weight of human = 60 kg Systemic exposure dose (SED) = A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60 = 0.0081 mg/kg bw/d No adverse observed effect level NOAEL = 25 mg/kg bw/d (oral developmental toxicity study, rabbit) No adjustment, 100 % oral absorption Margin of Safety NOAEL/SED = 3100","endpoint":"developmental toxicity","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 25","page":41,"route":"oral","species":"rabbit","study_id":"sccs_o_291_noael_014"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 100 % rabbit oral developmental developmental toxicity SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=100; DOSE=Absorption through the skin DAp (%) = 45 % Amount of cosmetic product applied daily A (g/d) = 0.54 g/d Concentration of ingredient in finished product C (%) = 0.2 % Typical body weight of human = 60 kg Systemic exposure dose (SED) = A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60 = 0.0081 mg/kg bw/d No adverse observed effect level NOAEL = 25...; EFFECT=on, according to the SCCS's Notes of Guidance 12th revision. Absorption through the skin DAp (%) = 45 % Amount of cosmetic product applied daily A (g/d) = 0.54 g/d Concentration of ingredient in finished product C (%) = 0.2 % Typical body weight of human = 60 kg Systemic exposure dose (SED) = A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60 = 0.0081 mg/kg bw/d No adverse observed effect level NOAEL = 25 mg/kg bw/d (oral developmental toxicity study, rabbit) No adjustment, 100 % oral absorption Margin of Safety NOAEL/SED = 3100; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"Absorption through the skin DAp (%) = 45 % Amount of cosmetic product applied daily A (g/d) = 0.54 g/d Concentration of ingredient in finished product C (%) = 0.2 % Typical body weight of human = 60 kg Systemic exposure dose (SED) = A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60 = 0.0081 mg/kg bw/d No adverse observed effect level NOAEL = 25...","duration":"developmental","effect":"on, according to the SCCS's Notes of Guidance 12th revision. Absorption through the skin DAp (%) = 45 % Amount of cosmetic product applied daily A (g/d) = 0.54 g/d Concentration of ingredient in finished product C (%) = 0.2 % Typical body weight of human = 60 kg Systemic exposure dose (SED) = A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60 = 0.0081 mg/kg bw/d No adverse observed effect level NOAEL = 25 mg/kg bw/d (oral developmental toxicity study, rabbit) No adjustment, 100 % oral absorption Margin of Safety NOAEL/SED = 3100","endpoint":"developmental toxicity","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"%","noael_value":"100","page":41,"route":"oral","species":"rabbit","study_id":"sccs_o_291_noael_015"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity =25 mg/kg bw/d rabbit oral developmental developmental toxicity SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT== 25; DOSE=s) An aggregate value of 17.4 g/d (269 mg/kg bw/d) for the amount of cosmetics applied daily is taken for MoS calculation according to the SCCS's Notes of Guidance 12th revision.; EFFECT=s) An aggregate value of 17.4 g/d (269 mg/kg bw/d) for the amount of cosmetics applied daily is taken for MoS calculation according to the SCCS's Notes of Guidance 12th revision. Absorption through the skin DAp (%) = 45 % Amount of cosmetic product applied daily A (g/d) = 14.54 g/d Concentration of ingredient in finished product C (%) = 0.15 % Typical body weight of human = 60 kg Systemic exposure dose (SED) = A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60 = 0.163 mg/kg bw/d No adverse observed effect level NOAEL = 25 mg/kg bw/d (oral developmental toxicity study, rabbit) No adjustment, 100 % oral absorption Margin of Safety adjusted NOAEL/SED = 153 SOPP in leave-on products (skin and hair cleansing products, make up products and oral care products) An aggregate value of 17.4 g/d (269 mg/kg bw/d) for the amount of cosmetics applied daily is taken for MoS calculation according to the SCCS's Notes of Guidance 12th revision. Absorption through the skin DAp (%) = 45 % Amount of cosmetic product applied daily A (g/d) = 14.5; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"s) An aggregate value of 17.4 g/d (269 mg/kg bw/d) for the amount of cosmetics applied daily is taken for MoS calculation according to the SCCS's Notes of Guidance 12th revision.","duration":"developmental","effect":"s) An aggregate value of 17.4 g/d (269 mg/kg bw/d) for the amount of cosmetics applied daily is taken for MoS calculation according to the SCCS's Notes of Guidance 12th revision. Absorption through the skin DAp (%) = 45 % Amount of cosmetic product applied daily A (g/d) = 14.54 g/d Concentration of ingredient in finished product C (%) = 0.15 % Typical body weight of human = 60 kg Systemic exposure dose (SED) = A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60 = 0.163 mg/kg bw/d No adverse observed effect level NOAEL = 25 mg/kg bw/d (oral developmental toxicity study, rabbit) No adjustment, 100 % oral absorption Margin of Safety adjusted NOAEL/SED = 153 SOPP in leave-on products (skin and hair cleansing products, make up products and oral care products) An aggregate value of 17.4 g/d (269 mg/kg bw/d) for the amount of cosmetics applied daily is taken for MoS calculation according to the SCCS's Notes of Guidance 12th revision. Absorption through the skin DAp (%) = 45 % Amount of cosmetic product applied daily A (g/d) = 14.5","endpoint":"developmental toxicity","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 25","page":42,"route":"oral","species":"rabbit","study_id":"sccs_o_291_noael_016"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 100 % rabbit oral developmental developmental toxicity SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=100; DOSE=Absorption through the skin DAp (%) = 45 % Amount of cosmetic product applied daily A (g/d) = 14.54 g/d Concentration of ingredient in finished product C (%) = 0.15 % Typical body weight of human = 60 kg Systemic exposure dose (SED) = A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60 = 0.163 mg/kg bw/d No adverse observed effect level NOAEL = 25...; EFFECT=ing to the SCCS's Notes of Guidance 12th revision. Absorption through the skin DAp (%) = 45 % Amount of cosmetic product applied daily A (g/d) = 14.54 g/d Concentration of ingredient in finished product C (%) = 0.15 % Typical body weight of human = 60 kg Systemic exposure dose (SED) = A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60 = 0.163 mg/kg bw/d No adverse observed effect level NOAEL = 25 mg/kg bw/d (oral developmental toxicity study, rabbit) No adjustment, 100 % oral absorption Margin of Safety adjusted NOAEL/SED = 153 SOPP in leave-on products (skin and hair cleansing products, make up products and oral care products) An aggregate value of 17.4 g/d (269 mg/kg bw/d) for the amount of cosmetics applied daily is taken for MoS calculation according to the SCCS's Notes of Guidance 12th revision. Absorption through the skin DAp (%) = 45 % Amount of cosmetic product applied daily A (g/d) = 14.54 g/d Concentration of ingredient in finished product C (%) = 0.15 % Typical body weight of human = 60 kg Systemic exposure dose; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"Absorption through the skin DAp (%) = 45 % Amount of cosmetic product applied daily A (g/d) = 14.54 g/d Concentration of ingredient in finished product C (%) = 0.15 % Typical body weight of human = 60 kg Systemic exposure dose (SED) = A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60 = 0.163 mg/kg bw/d No adverse observed effect level NOAEL = 25...","duration":"developmental","effect":"ing to the SCCS's Notes of Guidance 12th revision. Absorption through the skin DAp (%) = 45 % Amount of cosmetic product applied daily A (g/d) = 14.54 g/d Concentration of ingredient in finished product C (%) = 0.15 % Typical body weight of human = 60 kg Systemic exposure dose (SED) = A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60 = 0.163 mg/kg bw/d No adverse observed effect level NOAEL = 25 mg/kg bw/d (oral developmental toxicity study, rabbit) No adjustment, 100 % oral absorption Margin of Safety adjusted NOAEL/SED = 153 SOPP in leave-on products (skin and hair cleansing products, make up products and oral care products) An aggregate value of 17.4 g/d (269 mg/kg bw/d) for the amount of cosmetics applied daily is taken for MoS calculation according to the SCCS's Notes of Guidance 12th revision. Absorption through the skin DAp (%) = 45 % Amount of cosmetic product applied daily A (g/d) = 14.54 g/d Concentration of ingredient in finished product C (%) = 0.15 % Typical body weight of human = 60 kg Systemic exposure dose","endpoint":"developmental toxicity","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"%","noael_value":"100","page":42,"route":"oral","species":"rabbit","study_id":"sccs_o_291_noael_017"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity =25 mg/kg bw/d rabbit oral developmental developmental toxicity SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT== 25; DOSE=oduct applied daily A (g/d) = 14.54 g/d Concentration of ingredient in finished product C (%) = 0.15 % Typical body weight of human = 60 kg Systemic exposure dose (SED) from dermal leave-on products= A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60 = 0.163 mg/kg bw/d Systemic exposure dose (SED) from oral leave-on products /toothpaste, mouthwas...; EFFECT=oduct applied daily A (g/d) = 14.54 g/d Concentration of ingredient in finished product C (%) = 0.15 % Typical body weight of human = 60 kg Systemic exposure dose (SED) from dermal leave-on products= A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60 = 0.163 mg/kg bw/d Systemic exposure dose (SED) from oral leave-on products /toothpaste, mouthwash)= A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60 = 0.052 mg/kg bw/d SED from oral and dermal leave-on products: = 0.215 mg/kg bw/d No adverse observed effect level NOAEL = 25 mg/kg bw/d (oral developmental toxicity study, rabbit) No adjustment, 100 % oral absorption Margin of Safety adjusted NOAEL/SED = 116; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"oduct applied daily A (g/d) = 14.54 g/d Concentration of ingredient in finished product C (%) = 0.15 % Typical body weight of human = 60 kg Systemic exposure dose (SED) from dermal leave-on products= A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60 = 0.163 mg/kg bw/d Systemic exposure dose (SED) from oral leave-on products /toothpaste, mouthwas...","duration":"developmental","effect":"oduct applied daily A (g/d) = 14.54 g/d Concentration of ingredient in finished product C (%) = 0.15 % Typical body weight of human = 60 kg Systemic exposure dose (SED) from dermal leave-on products= A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60 = 0.163 mg/kg bw/d Systemic exposure dose (SED) from oral leave-on products /toothpaste, mouthwash)= A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60 = 0.052 mg/kg bw/d SED from oral and dermal leave-on products: = 0.215 mg/kg bw/d No adverse observed effect level NOAEL = 25 mg/kg bw/d (oral developmental toxicity study, rabbit) No adjustment, 100 % oral absorption Margin of Safety adjusted NOAEL/SED = 116","endpoint":"developmental toxicity","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 25","page":42,"route":"oral","species":"rabbit","study_id":"sccs_o_291_noael_018"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 100 % rabbit oral developmental developmental toxicity SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=100; DOSE== 60 kg Systemic exposure dose (SED) from dermal leave-on products= A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60 = 0.163 mg/kg bw/d Systemic exposure dose (SED) from oral leave-on products /toothpaste, mouthwash)= A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60 = 0.052 mg/kg bw/d SED from oral and dermal leave-on products: = 0.215 mg/kg b...; EFFECT== 60 kg Systemic exposure dose (SED) from dermal leave-on products= A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60 = 0.163 mg/kg bw/d Systemic exposure dose (SED) from oral leave-on products /toothpaste, mouthwash)= A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60 = 0.052 mg/kg bw/d SED from oral and dermal leave-on products: = 0.215 mg/kg bw/d No adverse observed effect level NOAEL = 25 mg/kg bw/d (oral developmental toxicity study, rabbit) No adjustment, 100 % oral absorption Margin of Safety adjusted NOAEL/SED = 116; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"= 60 kg Systemic exposure dose (SED) from dermal leave-on products= A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60 = 0.163 mg/kg bw/d Systemic exposure dose (SED) from oral leave-on products /toothpaste, mouthwash)= A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60 = 0.052 mg/kg bw/d SED from oral and dermal leave-on products: = 0.215 mg/kg b...","duration":"developmental","effect":"= 60 kg Systemic exposure dose (SED) from dermal leave-on products= A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60 = 0.163 mg/kg bw/d Systemic exposure dose (SED) from oral leave-on products /toothpaste, mouthwash)= A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60 = 0.052 mg/kg bw/d SED from oral and dermal leave-on products: = 0.215 mg/kg bw/d No adverse observed effect level NOAEL = 25 mg/kg bw/d (oral developmental toxicity study, rabbit) No adjustment, 100 % oral absorption Margin of Safety adjusted NOAEL/SED = 116","endpoint":"developmental toxicity","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"%","noael_value":"100","page":42,"route":"oral","species":"rabbit","study_id":"sccs_o_291_noael_019"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity =25 mg/kg bw/d rabbit oral developmental developmental toxicity SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT== 25; DOSE=cts An aggregate value of 0.54 g/d (8.3 mg/kg bw/d) for the amount of cosmetics applied daily is taken for MoS calculation, according to the SCCS's Notes of Guidance 12th revision.; EFFECT=cts An aggregate value of 0.54 g/d (8.3 mg/kg bw/d) for the amount of cosmetics applied daily is taken for MoS calculation, according to the SCCS's Notes of Guidance 12th revision. Absorption through the skin DAp (%) = 45 % Amount of cosmetic product applied daily A (g/d) = 0.54 g/d Concentration of ingredient in finished product C (%) = 0.2 % Typical body weight of human = 60 kg Systemic exposure dose (SED) = A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60 = 0.0081 mg/kg bw/d No adverse observed effect level NOAEL = 25 mg/kg bw/d (oral developmental toxicity study, rabbit) No adjustment, 100 % oral absorption Margin of Safety NOAEL/SED = 3100 3.6 DISCUSSION Physicochemical properties OPP exists as solid flakes or crystalline powder at ambient conditions. SOPP exists in hydrated and non-hydrated forms and also as flakes or crystalline powders. However, the dossier provided only refers to the non-hydrated form. Water solubilities of OPP and SOPP are quite high, for OPP a log Pow around 3 is given. The SCCS has uncertainty; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"cts An aggregate value of 0.54 g/d (8.3 mg/kg bw/d) for the amount of cosmetics applied daily is taken for MoS calculation, according to the SCCS's Notes of Guidance 12th revision.","duration":"developmental","effect":"cts An aggregate value of 0.54 g/d (8.3 mg/kg bw/d) for the amount of cosmetics applied daily is taken for MoS calculation, according to the SCCS's Notes of Guidance 12th revision. Absorption through the skin DAp (%) = 45 % Amount of cosmetic product applied daily A (g/d) = 0.54 g/d Concentration of ingredient in finished product C (%) = 0.2 % Typical body weight of human = 60 kg Systemic exposure dose (SED) = A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60 = 0.0081 mg/kg bw/d No adverse observed effect level NOAEL = 25 mg/kg bw/d (oral developmental toxicity study, rabbit) No adjustment, 100 % oral absorption Margin of Safety NOAEL/SED = 3100 3.6 DISCUSSION Physicochemical properties OPP exists as solid flakes or crystalline powder at ambient conditions. SOPP exists in hydrated and non-hydrated forms and also as flakes or crystalline powders. However, the dossier provided only refers to the non-hydrated form. Water solubilities of OPP and SOPP are quite high, for OPP a log Pow around 3 is given. The SCCS has uncertainty","endpoint":"developmental toxicity","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 25","page":43,"route":"oral","species":"rabbit","study_id":"sccs_o_291_noael_020"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 100 % rabbit oral developmental developmental toxicity SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=100; DOSE=Absorption through the skin DAp (%) = 45 % Amount of cosmetic product applied daily A (g/d) = 0.54 g/d Concentration of ingredient in finished product C (%) = 0.2 % Typical body weight of human = 60 kg Systemic exposure dose (SED) = A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60 = 0.0081 mg/kg bw/d No adverse observed effect level NOAEL = 25...; EFFECT=on, according to the SCCS's Notes of Guidance 12th revision. Absorption through the skin DAp (%) = 45 % Amount of cosmetic product applied daily A (g/d) = 0.54 g/d Concentration of ingredient in finished product C (%) = 0.2 % Typical body weight of human = 60 kg Systemic exposure dose (SED) = A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60 = 0.0081 mg/kg bw/d No adverse observed effect level NOAEL = 25 mg/kg bw/d (oral developmental toxicity study, rabbit) No adjustment, 100 % oral absorption Margin of Safety NOAEL/SED = 3100 3.6 DISCUSSION Physicochemical properties OPP exists as solid flakes or crystalline powder at ambient conditions. SOPP exists in hydrated and non-hydrated forms and also as flakes or crystalline powders. However, the dossier provided only refers to the non-hydrated form. Water solubilities of OPP and SOPP are quite high, for OPP a log Pow around 3 is given. The SCCS has uncertainty over the validity of the Log Pow value reported for SOPP. The Applicant should either provide the actual study leading t; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"Absorption through the skin DAp (%) = 45 % Amount of cosmetic product applied daily A (g/d) = 0.54 g/d Concentration of ingredient in finished product C (%) = 0.2 % Typical body weight of human = 60 kg Systemic exposure dose (SED) = A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60 = 0.0081 mg/kg bw/d No adverse observed effect level NOAEL = 25...","duration":"developmental","effect":"on, according to the SCCS's Notes of Guidance 12th revision. Absorption through the skin DAp (%) = 45 % Amount of cosmetic product applied daily A (g/d) = 0.54 g/d Concentration of ingredient in finished product C (%) = 0.2 % Typical body weight of human = 60 kg Systemic exposure dose (SED) = A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60 = 0.0081 mg/kg bw/d No adverse observed effect level NOAEL = 25 mg/kg bw/d (oral developmental toxicity study, rabbit) No adjustment, 100 % oral absorption Margin of Safety NOAEL/SED = 3100 3.6 DISCUSSION Physicochemical properties OPP exists as solid flakes or crystalline powder at ambient conditions. SOPP exists in hydrated and non-hydrated forms and also as flakes or crystalline powders. However, the dossier provided only refers to the non-hydrated form. Water solubilities of OPP and SOPP are quite high, for OPP a log Pow around 3 is given. The SCCS has uncertainty over the validity of the Log Pow value reported for SOPP. The Applicant should either provide the actual study leading t","endpoint":"developmental toxicity","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"%","noael_value":"100","page":43,"route":"oral","species":"rabbit","study_id":"sccs_o_291_noael_021"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 300 mg/kg bw/day rat oral Prenatal developmental toxicity SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=300; DOSE=Prenatal developmental toxicity via gavage in SD rat, (25-35 females/group), similar to OCED TG 414 0, 100, 300 and 700 mg/kg bw/day, GD 6-15 Maternal toxicity At 700 mg/kg bw/day, ↓ body weight, body weight gain and absolute liver wight was observed.; EFFECT=↓ foetal body weight, ↑ frequency of foetuses with cervical ribs, ↓ mean number of ossified left/right phalanges in hindlegs, ↑ frequency of foetuses with externally visible malformations. Prenatal developmental toxicity via gavage in SD rat, (25-35 females/group), similar to OCED TG 414 0, 100, 300 and 700 mg/kg bw/day, GD 6-15 Maternal toxicity At 700 mg/kg bw/day, ↓ body weight, body weight gain and absolute liver wight was observed. At 300 mg/kg bw/day, decreased weight gain (not statistically significant) and NOAEL (maternal and evelopmental): 300 mg/kg bw/day (whereas SCCS has derived maternal NOAEL at 150 mg/kg bw/day) John et al., 1978 in (ECHA, 2023b)/KL2; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"Prenatal developmental toxicity via gavage in SD rat, (25-35 females/group), similar to OCED TG 414 0, 100, 300 and 700 mg/kg bw/day, GD 6-15 Maternal toxicity At 700 mg/kg bw/day, ↓ body weight, body weight gain and absolute liver wight was observed.","duration":"Prenatal","effect":"↓ foetal body weight, ↑ frequency of foetuses with cervical ribs, ↓ mean number of ossified left/right phalanges in hindlegs, ↑ frequency of foetuses with externally visible malformations. Prenatal developmental toxicity via gavage in SD rat, (25-35 females/group), similar to OCED TG 414 0, 100, 300 and 700 mg/kg bw/day, GD 6-15 Maternal toxicity At 700 mg/kg bw/day, ↓ body weight, body weight gain and absolute liver wight was observed. At 300 mg/kg bw/day, decreased weight gain (not statistically significant) and NOAEL (maternal and evelopmental): 300 mg/kg bw/day (whereas SCCS has derived maternal NOAEL at 150 mg/kg bw/day) John et al., 1978 in (ECHA, 2023b)/KL2","endpoint":"developmental toxicity","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"300","page":73,"route":"oral","species":"rat","study_id":"sccs_o_291_noael_052"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 150 mg/kg bw/day rat oral Prenatal developmental toxicity SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=150; DOSE=Prenatal developmental toxicity via gavage in SD rat, (25-35 females/group), similar to OCED TG 414 0, 100, 300 and 700 mg/kg bw/day, GD 6-15 Maternal toxicity At 700 mg/kg bw/day, ↓ body weight, body weight gain and absolute liver wight was observed.; EFFECT=fied left/right phalanges in hindlegs, ↑ frequency of foetuses with externally visible malformations. Prenatal developmental toxicity via gavage in SD rat, (25-35 females/group), similar to OCED TG 414 0, 100, 300 and 700 mg/kg bw/day, GD 6-15 Maternal toxicity At 700 mg/kg bw/day, ↓ body weight, body weight gain and absolute liver wight was observed. At 300 mg/kg bw/day, decreased weight gain (not statistically significant) and NOAEL (maternal and evelopmental): 300 mg/kg bw/day (whereas SCCS has derived maternal NOAEL at 150 mg/kg bw/day) John et al., 1978 in (ECHA, 2023b)/KL2; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"Prenatal developmental toxicity via gavage in SD rat, (25-35 females/group), similar to OCED TG 414 0, 100, 300 and 700 mg/kg bw/day, GD 6-15 Maternal toxicity At 700 mg/kg bw/day, ↓ body weight, body weight gain and absolute liver wight was observed.","duration":"Prenatal","effect":"fied left/right phalanges in hindlegs, ↑ frequency of foetuses with externally visible malformations. Prenatal developmental toxicity via gavage in SD rat, (25-35 females/group), similar to OCED TG 414 0, 100, 300 and 700 mg/kg bw/day, GD 6-15 Maternal toxicity At 700 mg/kg bw/day, ↓ body weight, body weight gain and absolute liver wight was observed. At 300 mg/kg bw/day, decreased weight gain (not statistically significant) and NOAEL (maternal and evelopmental): 300 mg/kg bw/day (whereas SCCS has derived maternal NOAEL at 150 mg/kg bw/day) John et al., 1978 in (ECHA, 2023b)/KL2","endpoint":"developmental toxicity","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"150","page":73,"route":"oral","species":"rat","study_id":"sccs_o_291_noael_053"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 700 mg/kg bw/day rat oral Developmental developmental toxicity SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=700; DOSE=Developmental toxicity At 700 mg/kg bw/day, ↑Incidence of post- implantation loss in foetuses and litters were observed.; LOAEL_VALUE=700 mg/kg bw/day; EFFECT=SCCS/1669/24 Final version Opinion on the safety of Biphenyl-2-ol and Sodium 2-biphenylolate (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 74 Study type, Species Doses Critical effects NOAEL or LOAEL Reference#/ KL rating reduced food consumption was observed. Developmental toxicity At 700 mg/kg bw/day, ↑Incidence of post- implantation loss in foetuses and litters were observed. Skeletal alteration: ↑Incidence foetuses with: Delayed ossification of sternebrae foetuses, skull foramen, skull bone island Prenatal developmental toxicity via gavage in Wistar rats, (11-20 females/group), similar to OCED TG 414 0, 150, 300, 600 and 1200 mg/kg bw/day, GD 6-15 Maternal toxicity At 1200 mg/kg bw/day, 10/11 dams; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"Developmental toxicity At 700 mg/kg bw/day, ↑Incidence of post- implantation loss in foetuses and litters were observed.","duration":"Developmental","effect":"SCCS/1669/24 Final version Opinion on the safety of Biphenyl-2-ol and Sodium 2-biphenylolate (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 74 Study type, Species Doses Critical effects NOAEL or LOAEL Reference#/ KL rating reduced food consumption was observed. Developmental toxicity At 700 mg/kg bw/day, ↑Incidence of post- implantation loss in foetuses and litters were observed. Skeletal alteration: ↑Incidence foetuses with: Delayed ossification of sternebrae foetuses, skull foramen, skull bone island Prenatal developmental toxicity via gavage in Wistar rats, (11-20 females/group), similar to OCED TG 414 0, 150, 300, 600 and 1200 mg/kg bw/day, GD 6-15 Maternal toxicity At 1200 mg/kg bw/day, 10/11 dams","endpoint":"developmental toxicity","ingredient":"s, toys, textiles, clothing,","loael_value":"700 mg/kg bw/day","noael_unit":"mg/kg bw/day","noael_value":"700","page":74,"route":"oral","species":"rat","study_id":"sccs_o_291_noael_054"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 150 mg/kg bw/day rat oral 9 days developmental toxicity SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=150; DOSE=At 600 mg/kg bw/day, ↓ body weight gain, clinical signs such as pregnant rats fell into ataxia for several hours.; EFFECT=after 3-9 days of treatment, clinical signs such as pregnant rats fell into ataxia for several hours. At 600 mg/kg bw/day, ↓ body weight gain, clinical signs such as pregnant rats fell into ataxia for several hours. At 300 mg/kg bw/day, ↓ body weight gain, clinical signs such as pregnant rats fell into ataxia for several hours. Developmental toxicity At 600 mg/kg bw/day, ↑ percentage of foetal death, ↓ mean foetal weight, ↑ foetal incidence of malformations. At 300 mg/kg bw/day, ↑ foetal incidence of malformations NOAEL (maternal and developmental): 150 mg/kg bw/day Note: SCCS considered the NOAEL for developmental at 600 mg/kg bw/day) Kaneda et al., 1978 in (ECHA, 2023b; ECHA RAC, 2022; SCCS, 2015)/KL2 Range finding Prenatal developmental toxicity via gavage in New Zealand rabbits, (7 females/ group), no guideline 0, 250, 500 and 750 mg/ kg bw/day GD 7-19 Maternal toxicity At 750 mg/kg bw/day, mortality: nine rabbits died prior to study termination. Two rabbits (one at 500 and one at 750 mg/kg bw/day) were found withdepositions; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"At 600 mg/kg bw/day, ↓ body weight gain, clinical signs such as pregnant rats fell into ataxia for several hours.","duration":"9 days","effect":"after 3-9 days of treatment, clinical signs such as pregnant rats fell into ataxia for several hours. At 600 mg/kg bw/day, ↓ body weight gain, clinical signs such as pregnant rats fell into ataxia for several hours. At 300 mg/kg bw/day, ↓ body weight gain, clinical signs such as pregnant rats fell into ataxia for several hours. Developmental toxicity At 600 mg/kg bw/day, ↑ percentage of foetal death, ↓ mean foetal weight, ↑ foetal incidence of malformations. At 300 mg/kg bw/day, ↑ foetal incidence of malformations NOAEL (maternal and developmental): 150 mg/kg bw/day Note: SCCS considered the NOAEL for developmental at 600 mg/kg bw/day) Kaneda et al., 1978 in (ECHA, 2023b; ECHA RAC, 2022; SCCS, 2015)/KL2 Range finding Prenatal developmental toxicity via gavage in New Zealand rabbits, (7 females/ group), no guideline 0, 250, 500 and 750 mg/ kg bw/day GD 7-19 Maternal toxicity At 750 mg/kg bw/day, mortality: nine rabbits died prior to study termination. Two rabbits (one at 500 and one at 750 mg/kg bw/day) were found withdepositions","endpoint":"developmental toxicity","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"150","page":74,"route":"oral","species":"rat","study_id":"sccs_o_291_noael_055"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 600 mg/kg bw/day rat oral Developmental developmental toxicity SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=600; DOSE=At 600 mg/kg bw/day, ↓ body weight gain, clinical signs such as pregnant rats fell into ataxia for several hours.; EFFECT=xia for several hours. At 600 mg/kg bw/day, ↓ body weight gain, clinical signs such as pregnant rats fell into ataxia for several hours. At 300 mg/kg bw/day, ↓ body weight gain, clinical signs such as pregnant rats fell into ataxia for several hours. Developmental toxicity At 600 mg/kg bw/day, ↑ percentage of foetal death, ↓ mean foetal weight, ↑ foetal incidence of malformations. At 300 mg/kg bw/day, ↑ foetal incidence of malformations NOAEL (maternal and developmental): 150 mg/kg bw/day Note: SCCS considered the NOAEL for developmental at 600 mg/kg bw/day) Kaneda et al., 1978 in (ECHA, 2023b; ECHA RAC, 2022; SCCS, 2015)/KL2 Range finding Prenatal developmental toxicity via gavage in New Zealand rabbits, (7 females/ group), no guideline 0, 250, 500 and 750 mg/ kg bw/day GD 7-19 Maternal toxicity At 750 mg/kg bw/day, mortality: nine rabbits died prior to study termination. Two rabbits (one at 500 and one at 750 mg/kg bw/day) were found withdepositions of the test material in the lungs. The remaining deaths were considered treatme; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"At 600 mg/kg bw/day, ↓ body weight gain, clinical signs such as pregnant rats fell into ataxia for several hours.","duration":"Developmental","effect":"xia for several hours. At 600 mg/kg bw/day, ↓ body weight gain, clinical signs such as pregnant rats fell into ataxia for several hours. At 300 mg/kg bw/day, ↓ body weight gain, clinical signs such as pregnant rats fell into ataxia for several hours. Developmental toxicity At 600 mg/kg bw/day, ↑ percentage of foetal death, ↓ mean foetal weight, ↑ foetal incidence of malformations. At 300 mg/kg bw/day, ↑ foetal incidence of malformations NOAEL (maternal and developmental): 150 mg/kg bw/day Note: SCCS considered the NOAEL for developmental at 600 mg/kg bw/day) Kaneda et al., 1978 in (ECHA, 2023b; ECHA RAC, 2022; SCCS, 2015)/KL2 Range finding Prenatal developmental toxicity via gavage in New Zealand rabbits, (7 females/ group), no guideline 0, 250, 500 and 750 mg/ kg bw/day GD 7-19 Maternal toxicity At 750 mg/kg bw/day, mortality: nine rabbits died prior to study termination. Two rabbits (one at 500 and one at 750 mg/kg bw/day) were found withdepositions of the test material in the lungs. The remaining deaths were considered treatme","endpoint":"developmental toxicity","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"600","page":74,"route":"oral","species":"rat","study_id":"sccs_o_291_noael_056"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 250 mg/kg bw/day rabbit oral Prenatal developmental toxicity SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=250; DOSE=SCCS, 2015)/KL2 Range finding Prenatal developmental toxicity via gavage in New Zealand rabbits, (7 females/ group), no guideline 0, 250, 500 and 750 mg/ kg bw/day GD 7-19 Maternal toxicity At 750 mg/kg bw/day, mortality: nine rabbits died prior to study termination.; LOAEL_VALUE=250 mg/kg bw/day; EFFECT=22; SCCS, 2015)/KL2 Range finding Prenatal developmental toxicity via gavage in New Zealand rabbits, (7 females/ group), no guideline 0, 250, 500 and 750 mg/ kg bw/day GD 7-19 Maternal toxicity At 750 mg/kg bw/day, mortality: nine rabbits died prior to study termination. Two rabbits (one at 500 and one at 750 mg/kg bw/day) were found withdepositions of the test material in the lungs. The remaining deaths were considered treatment related. ↓ body weight and LOAEL (maternal toxicity): 250 mg/kg bw/day; Developmental NOAEL cannot be established, since foetuses were not examined for skeletal, visceral, and external anomalies Zablotny et al., 1991, in (ECHA RAC, 2022; SCCS, 2015) /KL2; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"SCCS, 2015)/KL2 Range finding Prenatal developmental toxicity via gavage in New Zealand rabbits, (7 females/ group), no guideline 0, 250, 500 and 750 mg/ kg bw/day GD 7-19 Maternal toxicity At 750 mg/kg bw/day, mortality: nine rabbits died prior to study termination.","duration":"Prenatal","effect":"22; SCCS, 2015)/KL2 Range finding Prenatal developmental toxicity via gavage in New Zealand rabbits, (7 females/ group), no guideline 0, 250, 500 and 750 mg/ kg bw/day GD 7-19 Maternal toxicity At 750 mg/kg bw/day, mortality: nine rabbits died prior to study termination. Two rabbits (one at 500 and one at 750 mg/kg bw/day) were found withdepositions of the test material in the lungs. The remaining deaths were considered treatment related. ↓ body weight and LOAEL (maternal toxicity): 250 mg/kg bw/day; Developmental NOAEL cannot be established, since foetuses were not examined for skeletal, visceral, and external anomalies Zablotny et al., 1991, in (ECHA RAC, 2022; SCCS, 2015) /KL2","endpoint":"developmental toxicity","ingredient":"s, toys, textiles, clothing,","loael_value":"250 mg/kg bw/day","noael_unit":"mg/kg bw/day","noael_value":"250","page":74,"route":"oral","species":"rabbit","study_id":"sccs_o_291_noael_057"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 400 mg/ kg bw/ day mouse oral Prenatal developmental toxicity SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=400; DOSE=90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 76 Study type, Species Doses Critical effects NOAEL or LOAEL Reference#/ KL rating SOPP Prenatal...; EFFECT=SCCS/1669/24 Final version Opinion on the safety of Biphenyl-2-ol and Sodium 2-biphenylolate (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 76 Study type, Species Doses Critical effects NOAEL or LOAEL Reference#/ KL rating SOPP Prenatal developmental toxicity via gavage in JCL- ICR mice, (20 females/group), similar to OCED TG 414 0, 100, 200 and 400 mg/ kg bw/ day, GD 7-15 Maternal toxicity At 400 mg/kg bw/day, ↑ mortality (80% of unscheduled deaths), ↓ body weight and body weight gain, ↓ absolute weight of liver, heart, and spleen. At 200 mg/kg bw/day, ↑ mortality (20% of unscheduled deaths), ↓ body weight and body weight gain, ↑ relative lung weight at 100 mg/kg bw/day, ↓ body weight and body wei; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 76 Study type, Species Doses Critical effects NOAEL or LOAEL Reference#/ KL rating SOPP Prenatal...","duration":"Prenatal","effect":"SCCS/1669/24 Final version Opinion on the safety of Biphenyl-2-ol and Sodium 2-biphenylolate (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 76 Study type, Species Doses Critical effects NOAEL or LOAEL Reference#/ KL rating SOPP Prenatal developmental toxicity via gavage in JCL- ICR mice, (20 females/group), similar to OCED TG 414 0, 100, 200 and 400 mg/ kg bw/ day, GD 7-15 Maternal toxicity At 400 mg/kg bw/day, ↑ mortality (80% of unscheduled deaths), ↓ body weight and body weight gain, ↓ absolute weight of liver, heart, and spleen. At 200 mg/kg bw/day, ↑ mortality (20% of unscheduled deaths), ↓ body weight and body weight gain, ↑ relative lung weight at 100 mg/kg bw/day, ↓ body weight and body wei","endpoint":"developmental toxicity","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/ kg bw/ day","noael_value":"400","page":76,"route":"oral","species":"mouse","study_id":"sccs_o_291_noael_061"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 250 mg/kg bw/day - - developmental developmental toxicity SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=250; DOSE=er of implantation sites/dam, ↓ litter size (live foetuses), ↓ foetal body weight, ↓ mean number of ossified left/right phalanges in forelegs and hindlegs At 100 mg/kg bw/day, ↓ foetal body weight, ↓ mean number of ossified left/right phalanges in forelegs and hindlegs.; LOAEL_VALUE=100 mg/kg bw/day; EFFECT=er of implantation sites/dam, ↓ litter size (live foetuses), ↓ foetal body weight, ↓ mean number of ossified left/right phalanges in forelegs and hindlegs At 100 mg/kg bw/day, ↓ foetal body weight, ↓ mean number of ossified left/right phalanges in forelegs and hindlegs. LOAEL (maternal and foetal toxicity): 100 mg/kg bw/day Ogata et al., 1978b in (Cal EPA, 2007; Health Canada, 2020; SCCS, 2015)/KL4 j Various regulatory reviews such as US EPA, 2006; Cal EPA, 2007; CAR, 2015; HC, 2020; RAC, 2022 have considered the NOAEL for developmental toxicity at ≥250 mg/kg bw/day whereas SCCS, 2015 and EC, 2023, have set the NOAEL for developmental toxicity at 25 mg/kg bw/day. The SCCS, 2015 and EC, 2023 and CLH derived, NOAEL for maternal and developmental toxicity as 100 and 25 mg/kg bw/day, respectively.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"er of implantation sites/dam, ↓ litter size (live foetuses), ↓ foetal body weight, ↓ mean number of ossified left/right phalanges in forelegs and hindlegs At 100 mg/kg bw/day, ↓ foetal body weight, ↓ mean number of ossified left/right phalanges in forelegs and hindlegs.","duration":"developmental","effect":"er of implantation sites/dam, ↓ litter size (live foetuses), ↓ foetal body weight, ↓ mean number of ossified left/right phalanges in forelegs and hindlegs At 100 mg/kg bw/day, ↓ foetal body weight, ↓ mean number of ossified left/right phalanges in forelegs and hindlegs. LOAEL (maternal and foetal toxicity): 100 mg/kg bw/day Ogata et al., 1978b in (Cal EPA, 2007; Health Canada, 2020; SCCS, 2015)/KL4 j Various regulatory reviews such as US EPA, 2006; Cal EPA, 2007; CAR, 2015; HC, 2020; RAC, 2022 have considered the NOAEL for developmental toxicity at ≥250 mg/kg bw/day whereas SCCS, 2015 and EC, 2023, have set the NOAEL for developmental toxicity at 25 mg/kg bw/day. The SCCS, 2015 and EC, 2023 and CLH derived, NOAEL for maternal and developmental toxicity as 100 and 25 mg/kg bw/day, respectively.","endpoint":"developmental toxicity","ingredient":"s, toys, textiles, clothing,","loael_value":"100 mg/kg bw/day","noael_unit":"mg/kg bw/day","noael_value":"250","page":76,"route":"","species":"","study_id":"sccs_o_291_noael_062"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 25 mg/kg bw/day - - developmental developmental toxicity SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=25; DOSE=ossified left/right phalanges in forelegs and hindlegs At 100 mg/kg bw/day, ↓ foetal body weight, ↓ mean number of ossified left/right phalanges in forelegs and hindlegs.; LOAEL_VALUE=100 mg/kg bw/day; EFFECT=ossified left/right phalanges in forelegs and hindlegs At 100 mg/kg bw/day, ↓ foetal body weight, ↓ mean number of ossified left/right phalanges in forelegs and hindlegs. LOAEL (maternal and foetal toxicity): 100 mg/kg bw/day Ogata et al., 1978b in (Cal EPA, 2007; Health Canada, 2020; SCCS, 2015)/KL4 j Various regulatory reviews such as US EPA, 2006; Cal EPA, 2007; CAR, 2015; HC, 2020; RAC, 2022 have considered the NOAEL for developmental toxicity at ≥250 mg/kg bw/day whereas SCCS, 2015 and EC, 2023, have set the NOAEL for developmental toxicity at 25 mg/kg bw/day. The SCCS, 2015 and EC, 2023 and CLH derived, NOAEL for maternal and developmental toxicity as 100 and 25 mg/kg bw/day, respectively.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"ossified left/right phalanges in forelegs and hindlegs At 100 mg/kg bw/day, ↓ foetal body weight, ↓ mean number of ossified left/right phalanges in forelegs and hindlegs.","duration":"developmental","effect":"ossified left/right phalanges in forelegs and hindlegs At 100 mg/kg bw/day, ↓ foetal body weight, ↓ mean number of ossified left/right phalanges in forelegs and hindlegs. LOAEL (maternal and foetal toxicity): 100 mg/kg bw/day Ogata et al., 1978b in (Cal EPA, 2007; Health Canada, 2020; SCCS, 2015)/KL4 j Various regulatory reviews such as US EPA, 2006; Cal EPA, 2007; CAR, 2015; HC, 2020; RAC, 2022 have considered the NOAEL for developmental toxicity at ≥250 mg/kg bw/day whereas SCCS, 2015 and EC, 2023, have set the NOAEL for developmental toxicity at 25 mg/kg bw/day. The SCCS, 2015 and EC, 2023 and CLH derived, NOAEL for maternal and developmental toxicity as 100 and 25 mg/kg bw/day, respectively.","endpoint":"developmental toxicity","ingredient":"s, toys, textiles, clothing,","loael_value":"100 mg/kg bw/day","noael_unit":"mg/kg bw/day","noael_value":"25","page":76,"route":"","species":"","study_id":"sccs_o_291_noael_063"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 25 mg/kg bw/day - - developmental developmental toxicity SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=25; DOSE=100 mg/kg bw/day Ogata et al., 1978b in (Cal EPA, 2007;; LOAEL_VALUE=100 mg/kg bw/day; EFFECT=↓ mean number of ossified left/right phalanges in forelegs and hindlegs. LOAEL (maternal and foetal toxicity): 100 mg/kg bw/day Ogata et al., 1978b in (Cal EPA, 2007; Health Canada, 2020; SCCS, 2015)/KL4 j Various regulatory reviews such as US EPA, 2006; Cal EPA, 2007; CAR, 2015; HC, 2020; RAC, 2022 have considered the NOAEL for developmental toxicity at ≥250 mg/kg bw/day whereas SCCS, 2015 and EC, 2023, have set the NOAEL for developmental toxicity at 25 mg/kg bw/day. The SCCS, 2015 and EC, 2023 and CLH derived, NOAEL for maternal and developmental toxicity as 100 and 25 mg/kg bw/day, respectively.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"100 mg/kg bw/day Ogata et al., 1978b in (Cal EPA, 2007;","duration":"developmental","effect":"↓ mean number of ossified left/right phalanges in forelegs and hindlegs. LOAEL (maternal and foetal toxicity): 100 mg/kg bw/day Ogata et al., 1978b in (Cal EPA, 2007; Health Canada, 2020; SCCS, 2015)/KL4 j Various regulatory reviews such as US EPA, 2006; Cal EPA, 2007; CAR, 2015; HC, 2020; RAC, 2022 have considered the NOAEL for developmental toxicity at ≥250 mg/kg bw/day whereas SCCS, 2015 and EC, 2023, have set the NOAEL for developmental toxicity at 25 mg/kg bw/day. The SCCS, 2015 and EC, 2023 and CLH derived, NOAEL for maternal and developmental toxicity as 100 and 25 mg/kg bw/day, respectively.","endpoint":"developmental toxicity","ingredient":"s, toys, textiles, clothing,","loael_value":"100 mg/kg bw/day","noael_unit":"mg/kg bw/day","noael_value":"25","page":76,"route":"","species":"","study_id":"sccs_o_291_noael_064"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 1450 mg/kg bw/day mouse oral Prenatal developmental toxicity SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=1450; DOSE=Prenatal developmental toxicity via gavage in JCL- ICR mice, (21 females/group), similar to OCED TG 414 | 0, 1450, 1740 and 2100 mg/kg bw/day, GD 7-15 | Maternal toxicity At 2100 mg/kg bw/day, ↑ mortality:; LOAEL_VALUE=1450 mg/kg bw/day; EFFECT=Unlabeled table on page 72: Prenatal developmental toxicity via gavage in JCL- ICR mice, (21 females/group), similar to OCED TG 414 | 0, 1450, 1740 and 2100 mg/kg bw/day, GD 7-15 | Maternal toxicity At 2100 mg/kg bw/day, ↑ mortality: 5 mice died on GD 8, 7 on GD 9 and 2 each on GD 11 and 12, ↓ body weight/body weight gain and ↓ in absolute/relative heart weight were observed. At 1740 mg/kg bw/day, ↑ | LOAEL (maternal and developmental toxicity): 1450 mg/kg bw/day | Ogata et al., 1978 in (EC, 2023; ECHA, 2023b; ECHA RAC, 2022)/KL2; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"Prenatal developmental toxicity via gavage in JCL- ICR mice, (21 females/group), similar to OCED TG 414 | 0, 1450, 1740 and 2100 mg/kg bw/day, GD 7-15 | Maternal toxicity At 2100 mg/kg bw/day, ↑ mortality:","duration":"Prenatal","effect":"Unlabeled table on page 72: Prenatal developmental toxicity via gavage in JCL- ICR mice, (21 females/group), similar to OCED TG 414 | 0, 1450, 1740 and 2100 mg/kg bw/day, GD 7-15 | Maternal toxicity At 2100 mg/kg bw/day, ↑ mortality: 5 mice died on GD 8, 7 on GD 9 and 2 each on GD 11 and 12, ↓ body weight/body weight gain and ↓ in absolute/relative heart weight were observed. At 1740 mg/kg bw/day, ↑ | LOAEL (maternal and developmental toxicity): 1450 mg/kg bw/day | Ogata et al., 1978 in (EC, 2023; ECHA, 2023b; ECHA RAC, 2022)/KL2","endpoint":"developmental toxicity","ingredient":"s, toys, textiles, clothing,","loael_value":"1450 mg/kg bw/day","noael_unit":"mg/kg bw/day","noael_value":"1450","page":72,"route":"oral","species":"mouse","study_id":"sccs_o_291_noael_122"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 700 mg/kg bw/day rat oral Prenatal developmental toxicity SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=700; DOSE=Prenatal developmental toxicity via gavage in SD rat, (25-35 females/group), similar to OCED TG 414 | 0, 100, 300 and 700 mg/kg bw/day, GD 6-15 | Maternal toxicity At 700 mg/kg bw/day, ↓ body weight, body weight gain and absolute liver wight was observed.; EFFECT=Unlabeled table on page 73: Prenatal developmental toxicity via gavage in SD rat, (25-35 females/group), similar to OCED TG 414 | 0, 100, 300 and 700 mg/kg bw/day, GD 6-15 | Maternal toxicity At 700 mg/kg bw/day, ↓ body weight, body weight gain and absolute liver wight was observed. At 300 mg/kg bw/day, decreased weight gain (not statistically significant) and | NOAEL (maternal and evelopmental): 300 mg/kg bw/day (whereas SCCS has derived maternal NOAEL at 150 mg/kg bw/day) | John et al., 1978 in (ECHA, 2023b)/KL2; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"Prenatal developmental toxicity via gavage in SD rat, (25-35 females/group), similar to OCED TG 414 | 0, 100, 300 and 700 mg/kg bw/day, GD 6-15 | Maternal toxicity At 700 mg/kg bw/day, ↓ body weight, body weight gain and absolute liver wight was observed.","duration":"Prenatal","effect":"Unlabeled table on page 73: Prenatal developmental toxicity via gavage in SD rat, (25-35 females/group), similar to OCED TG 414 | 0, 100, 300 and 700 mg/kg bw/day, GD 6-15 | Maternal toxicity At 700 mg/kg bw/day, ↓ body weight, body weight gain and absolute liver wight was observed. At 300 mg/kg bw/day, decreased weight gain (not statistically significant) and | NOAEL (maternal and evelopmental): 300 mg/kg bw/day (whereas SCCS has derived maternal NOAEL at 150 mg/kg bw/day) | John et al., 1978 in (ECHA, 2023b)/KL2","endpoint":"developmental toxicity","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"700","page":73,"route":"oral","species":"rat","study_id":"sccs_o_291_noael_124"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 300 mg/kg bw/day rat oral Prenatal developmental toxicity SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=300; DOSE=Prenatal developmental toxicity via gavage in SD rat, (25-35 females/group), similar to OCED TG 414 | 0, 100, 300 and 700 mg/kg bw/day, GD 6-15 | Maternal toxicity At 700 mg/kg bw/day, ↓ body weight, body weight gain and absolute liver wight was observed.; EFFECT=Unlabeled table on page 73: Prenatal developmental toxicity via gavage in SD rat, (25-35 females/group), similar to OCED TG 414 | 0, 100, 300 and 700 mg/kg bw/day, GD 6-15 | Maternal toxicity At 700 mg/kg bw/day, ↓ body weight, body weight gain and absolute liver wight was observed. At 300 mg/kg bw/day, decreased weight gain (not statistically significant) and | NOAEL (maternal and evelopmental): 300 mg/kg bw/day (whereas SCCS has derived maternal NOAEL at 150 mg/kg bw/day) | John et al., 1978 in (ECHA, 2023b)/KL2; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"Prenatal developmental toxicity via gavage in SD rat, (25-35 females/group), similar to OCED TG 414 | 0, 100, 300 and 700 mg/kg bw/day, GD 6-15 | Maternal toxicity At 700 mg/kg bw/day, ↓ body weight, body weight gain and absolute liver wight was observed.","duration":"Prenatal","effect":"Unlabeled table on page 73: Prenatal developmental toxicity via gavage in SD rat, (25-35 females/group), similar to OCED TG 414 | 0, 100, 300 and 700 mg/kg bw/day, GD 6-15 | Maternal toxicity At 700 mg/kg bw/day, ↓ body weight, body weight gain and absolute liver wight was observed. At 300 mg/kg bw/day, decreased weight gain (not statistically significant) and | NOAEL (maternal and evelopmental): 300 mg/kg bw/day (whereas SCCS has derived maternal NOAEL at 150 mg/kg bw/day) | John et al., 1978 in (ECHA, 2023b)/KL2","endpoint":"developmental toxicity","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"300","page":73,"route":"oral","species":"rat","study_id":"sccs_o_291_noael_125"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 1200 mg/kg bw/day rat oral Prenatal developmental toxicity SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=1200; DOSE=Prenatal developmental toxicity via gavage in Wistar rats, (11-20 females/group), similar to OCED TG 414 | 0, 150, 300, 600 and 1200 mg/kg bw/day, GD 6-15 | Maternal toxicity At 1200 mg/kg bw/day, 10/11 dams died after 3-9 days of treatment, clinical signs such as pregnant rats fell into ataxia for several hours.; EFFECT=Unlabeled table on page 74: Prenatal developmental toxicity via gavage in Wistar rats, (11-20 females/group), similar to OCED TG 414 | 0, 150, 300, 600 and 1200 mg/kg bw/day, GD 6-15 | Maternal toxicity At 1200 mg/kg bw/day, 10/11 dams died after 3-9 days of treatment, clinical signs such as pregnant rats fell into ataxia for several hours. At 600 mg/kg bw/day, ↓ body weight gain, clinical signs such as pregnant rats fell into ataxia for several hours. At 300 mg/kg bw/day, ↓ body weight gain, clinical signs such as pregnant rats fell into ataxia for several hours. Developmental toxicity At 600 mg/kg bw/day, ↑ percentage of foetal death, ↓ mean foetal weight, ↑ foetal incidence of malformations. At 300 mg/kg bw/day, ↑ foetal incidence of malformations | NOAEL (maternal and developmental): 150 mg/kg bw/day Note: SCCS considered the NOAEL for developmental at 600 mg/kg bw/day) | Kaneda et al., 1978 in (ECHA, 2023b; ECHA RAC, 2022; SCCS, 2015)/KL2; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"Prenatal developmental toxicity via gavage in Wistar rats, (11-20 females/group), similar to OCED TG 414 | 0, 150, 300, 600 and 1200 mg/kg bw/day, GD 6-15 | Maternal toxicity At 1200 mg/kg bw/day, 10/11 dams died after 3-9 days of treatment, clinical signs such as pregnant rats fell into ataxia for several hours.","duration":"Prenatal","effect":"Unlabeled table on page 74: Prenatal developmental toxicity via gavage in Wistar rats, (11-20 females/group), similar to OCED TG 414 | 0, 150, 300, 600 and 1200 mg/kg bw/day, GD 6-15 | Maternal toxicity At 1200 mg/kg bw/day, 10/11 dams died after 3-9 days of treatment, clinical signs such as pregnant rats fell into ataxia for several hours. At 600 mg/kg bw/day, ↓ body weight gain, clinical signs such as pregnant rats fell into ataxia for several hours. At 300 mg/kg bw/day, ↓ body weight gain, clinical signs such as pregnant rats fell into ataxia for several hours. Developmental toxicity At 600 mg/kg bw/day, ↑ percentage of foetal death, ↓ mean foetal weight, ↑ foetal incidence of malformations. At 300 mg/kg bw/day, ↑ foetal incidence of malformations | NOAEL (maternal and developmental): 150 mg/kg bw/day Note: SCCS considered the NOAEL for developmental at 600 mg/kg bw/day) | Kaneda et al., 1978 in (ECHA, 2023b; ECHA RAC, 2022; SCCS, 2015)/KL2","endpoint":"developmental toxicity","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"1200","page":74,"route":"oral","species":"rat","study_id":"sccs_o_291_noael_127"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 750 mg/ kg bw/day rabbit oral Prenatal developmental toxicity SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=750; DOSE=Range finding Prenatal developmental toxicity via gavage in New Zealand rabbits, (7 females/ group), no guideline | 0, 250, 500 and 750 mg/ kg bw/day GD 7-19 | Maternal toxicity At 750 mg/kg bw/day, mortality: nine rabbits died prior to study termination.; LOAEL_VALUE=250 mg/kg bw/day; EFFECT=Unlabeled table on page 74: Range finding Prenatal developmental toxicity via gavage in New Zealand rabbits, (7 females/ group), no guideline | 0, 250, 500 and 750 mg/ kg bw/day GD 7-19 | Maternal toxicity At 750 mg/kg bw/day, mortality: nine rabbits died prior to study termination. Two rabbits (one at 500 and one at 750 mg/kg bw/day) were found withdepositions of the test material in the lungs. The remaining deaths were considered treatment related. ↓ body weight and | LOAEL (maternal toxicity): 250 mg/kg bw/day; Developmental NOAEL cannot be established, since foetuses were not examined for skeletal, visceral, and external anomalies | Zablotny et al., 1991, in (ECHA RAC, 2022; SCCS, 2015) /KL2; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"Range finding Prenatal developmental toxicity via gavage in New Zealand rabbits, (7 females/ group), no guideline | 0, 250, 500 and 750 mg/ kg bw/day GD 7-19 | Maternal toxicity At 750 mg/kg bw/day, mortality: nine rabbits died prior to study termination.","duration":"Prenatal","effect":"Unlabeled table on page 74: Range finding Prenatal developmental toxicity via gavage in New Zealand rabbits, (7 females/ group), no guideline | 0, 250, 500 and 750 mg/ kg bw/day GD 7-19 | Maternal toxicity At 750 mg/kg bw/day, mortality: nine rabbits died prior to study termination. Two rabbits (one at 500 and one at 750 mg/kg bw/day) were found withdepositions of the test material in the lungs. The remaining deaths were considered treatment related. ↓ body weight and | LOAEL (maternal toxicity): 250 mg/kg bw/day; Developmental NOAEL cannot be established, since foetuses were not examined for skeletal, visceral, and external anomalies | Zablotny et al., 1991, in (ECHA RAC, 2022; SCCS, 2015) /KL2","endpoint":"developmental toxicity","ingredient":"s, toys, textiles, clothing,","loael_value":"250 mg/kg bw/day","noael_unit":"mg/ kg bw/day","noael_value":"750","page":74,"route":"oral","species":"rabbit","study_id":"sccs_o_291_noael_128"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 150 mg/kg bw/day rat oral Prenatal developmental toxicity SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=150; DOSE=Prenatal developmental toxicity via gavage in Wistar rats, (11-20 females/group), similar to OCED TG 414 | 0, 150, 300, 600 and 1200 mg/kg bw/day, GD 6-15 | Maternal toxicity At 1200 mg/kg bw/day, 10/11 dams died after 3-9 days of treatment, clinical signs such as pregnant rats fell into ataxia for several hours.; EFFECT=Unlabeled table on page 74: Prenatal developmental toxicity via gavage in Wistar rats, (11-20 females/group), similar to OCED TG 414 | 0, 150, 300, 600 and 1200 mg/kg bw/day, GD 6-15 | Maternal toxicity At 1200 mg/kg bw/day, 10/11 dams died after 3-9 days of treatment, clinical signs such as pregnant rats fell into ataxia for several hours. At 600 mg/kg bw/day, ↓ body weight gain, clinical signs such as pregnant rats fell into ataxia for several hours. At 300 mg/kg bw/day, ↓ body weight gain, clinical signs such as pregnant rats fell into ataxia for several hours. Developmental toxicity At 600 mg/kg bw/day, ↑ percentage of foetal death, ↓ mean foetal weight, ↑ foetal incidence of malformations. At 300 mg/kg bw/day, ↑ foetal incidence of malformations | NOAEL (maternal and developmental): 150 mg/kg bw/day Note: SCCS considered the NOAEL for developmental at 600 mg/kg bw/day) | Kaneda et al., 1978 in (ECHA, 2023b; ECHA RAC, 2022; SCCS, 2015)/KL2; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"Prenatal developmental toxicity via gavage in Wistar rats, (11-20 females/group), similar to OCED TG 414 | 0, 150, 300, 600 and 1200 mg/kg bw/day, GD 6-15 | Maternal toxicity At 1200 mg/kg bw/day, 10/11 dams died after 3-9 days of treatment, clinical signs such as pregnant rats fell into ataxia for several hours.","duration":"Prenatal","effect":"Unlabeled table on page 74: Prenatal developmental toxicity via gavage in Wistar rats, (11-20 females/group), similar to OCED TG 414 | 0, 150, 300, 600 and 1200 mg/kg bw/day, GD 6-15 | Maternal toxicity At 1200 mg/kg bw/day, 10/11 dams died after 3-9 days of treatment, clinical signs such as pregnant rats fell into ataxia for several hours. At 600 mg/kg bw/day, ↓ body weight gain, clinical signs such as pregnant rats fell into ataxia for several hours. At 300 mg/kg bw/day, ↓ body weight gain, clinical signs such as pregnant rats fell into ataxia for several hours. Developmental toxicity At 600 mg/kg bw/day, ↑ percentage of foetal death, ↓ mean foetal weight, ↑ foetal incidence of malformations. At 300 mg/kg bw/day, ↑ foetal incidence of malformations | NOAEL (maternal and developmental): 150 mg/kg bw/day Note: SCCS considered the NOAEL for developmental at 600 mg/kg bw/day) | Kaneda et al., 1978 in (ECHA, 2023b; ECHA RAC, 2022; SCCS, 2015)/KL2","endpoint":"developmental toxicity","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"150","page":74,"route":"oral","species":"rat","study_id":"sccs_o_291_noael_129"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 250 mg/kg bw/day rabbit oral Prenatal developmental toxicity SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=250; DOSE=Range finding Prenatal developmental toxicity via gavage in New Zealand rabbits, (7 females/ group), no guideline | 0, 250, 500 and 750 mg/ kg bw/day GD 7-19 | Maternal toxicity At 750 mg/kg bw/day, mortality: nine rabbits died prior to study termination.; LOAEL_VALUE=250 mg/kg bw/day; EFFECT=Unlabeled table on page 74: Range finding Prenatal developmental toxicity via gavage in New Zealand rabbits, (7 females/ group), no guideline | 0, 250, 500 and 750 mg/ kg bw/day GD 7-19 | Maternal toxicity At 750 mg/kg bw/day, mortality: nine rabbits died prior to study termination. Two rabbits (one at 500 and one at 750 mg/kg bw/day) were found withdepositions of the test material in the lungs. The remaining deaths were considered treatment related. ↓ body weight and | LOAEL (maternal toxicity): 250 mg/kg bw/day; Developmental NOAEL cannot be established, since foetuses were not examined for skeletal, visceral, and external anomalies | Zablotny et al., 1991, in (ECHA RAC, 2022; SCCS, 2015) /KL2; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"Range finding Prenatal developmental toxicity via gavage in New Zealand rabbits, (7 females/ group), no guideline | 0, 250, 500 and 750 mg/ kg bw/day GD 7-19 | Maternal toxicity At 750 mg/kg bw/day, mortality: nine rabbits died prior to study termination.","duration":"Prenatal","effect":"Unlabeled table on page 74: Range finding Prenatal developmental toxicity via gavage in New Zealand rabbits, (7 females/ group), no guideline | 0, 250, 500 and 750 mg/ kg bw/day GD 7-19 | Maternal toxicity At 750 mg/kg bw/day, mortality: nine rabbits died prior to study termination. Two rabbits (one at 500 and one at 750 mg/kg bw/day) were found withdepositions of the test material in the lungs. The remaining deaths were considered treatment related. ↓ body weight and | LOAEL (maternal toxicity): 250 mg/kg bw/day; Developmental NOAEL cannot be established, since foetuses were not examined for skeletal, visceral, and external anomalies | Zablotny et al., 1991, in (ECHA RAC, 2022; SCCS, 2015) /KL2","endpoint":"developmental toxicity","ingredient":"s, toys, textiles, clothing,","loael_value":"250 mg/kg bw/day","noael_unit":"mg/kg bw/day","noael_value":"250","page":74,"route":"oral","species":"rabbit","study_id":"sccs_o_291_noael_130"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies irritation 100 mg/kg bw/day rat dermal 21-day irritation SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=100; DOSE=5.95 mg (equivalent to 200 / 240 mg/kg bw/day for males and females, respectively) NTP, 1986 in ECHA RAC, 2022/KL2 21-day dermal toxicity study in Fischer 344 rats (5/sex/group);; LOAEL_VALUE=240 mg/kg bw/day; EFFECT=males and 7/10 females that received 5.95 mg, and in 1/10 male and 1/10 female of control group LOAEL (dermal toxicity): 5.95 mg (equivalent to 200 / 240 mg/kg bw/day for males and females, respectively) NTP, 1986 in ECHA RAC, 2022/KL2 21-day dermal toxicity study in Fischer 344 rats (5/sex/group); OECD TG 410 0, 100, 500 and 1000 mg/kg bw/day, 5 days/week for 21 days At 1000 mg/kg bw/day, ↑ incidence of local skin irritation in males and females; ↑ Incidence of hyperkeratosis and acanthosis in males and females. NOAEL (local toxicity): 100 mg/kg bw/day; NOAEL for (systemic toxicity): 1000 mg/kg bw/day Bomhard, 2002 in ECHA RAC, 2022; ECHA, 2023a/KL1; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"5.95 mg (equivalent to 200 / 240 mg/kg bw/day for males and females, respectively) NTP, 1986 in ECHA RAC, 2022/KL2 21-day dermal toxicity study in Fischer 344 rats (5/sex/group);","duration":"21-day","effect":"males and 7/10 females that received 5.95 mg, and in 1/10 male and 1/10 female of control group LOAEL (dermal toxicity): 5.95 mg (equivalent to 200 / 240 mg/kg bw/day for males and females, respectively) NTP, 1986 in ECHA RAC, 2022/KL2 21-day dermal toxicity study in Fischer 344 rats (5/sex/group); OECD TG 410 0, 100, 500 and 1000 mg/kg bw/day, 5 days/week for 21 days At 1000 mg/kg bw/day, ↑ incidence of local skin irritation in males and females; ↑ Incidence of hyperkeratosis and acanthosis in males and females. NOAEL (local toxicity): 100 mg/kg bw/day; NOAEL for (systemic toxicity): 1000 mg/kg bw/day Bomhard, 2002 in ECHA RAC, 2022; ECHA, 2023a/KL1","endpoint":"irritation","ingredient":"s, toys, textiles, clothing,","loael_value":"240 mg/kg bw/day","noael_unit":"mg/kg bw/day","noael_value":"100","page":69,"route":"dermal","species":"rat","study_id":"sccs_o_291_noael_040"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies irritation 100 mg/kg bw/day rat dermal 21-day irritation SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=100; DOSE=5.95 mg (equivalent to 200 / 240 mg/kg bw/day for males and females, respectively) NTP, 1986 in ECHA RAC, 2022/KL2 21-day dermal toxicity study in Fischer 344 rats (5/sex/group);; LOAEL_VALUE=240 mg/kg bw/day; EFFECT=mg, and in 1/10 male and 1/10 female of control group LOAEL (dermal toxicity): 5.95 mg (equivalent to 200 / 240 mg/kg bw/day for males and females, respectively) NTP, 1986 in ECHA RAC, 2022/KL2 21-day dermal toxicity study in Fischer 344 rats (5/sex/group); OECD TG 410 0, 100, 500 and 1000 mg/kg bw/day, 5 days/week for 21 days At 1000 mg/kg bw/day, ↑ incidence of local skin irritation in males and females; ↑ Incidence of hyperkeratosis and acanthosis in males and females. NOAEL (local toxicity): 100 mg/kg bw/day; NOAEL for (systemic toxicity): 1000 mg/kg bw/day Bomhard, 2002 in ECHA RAC, 2022; ECHA, 2023a/KL1; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"5.95 mg (equivalent to 200 / 240 mg/kg bw/day for males and females, respectively) NTP, 1986 in ECHA RAC, 2022/KL2 21-day dermal toxicity study in Fischer 344 rats (5/sex/group);","duration":"21-day","effect":"mg, and in 1/10 male and 1/10 female of control group LOAEL (dermal toxicity): 5.95 mg (equivalent to 200 / 240 mg/kg bw/day for males and females, respectively) NTP, 1986 in ECHA RAC, 2022/KL2 21-day dermal toxicity study in Fischer 344 rats (5/sex/group); OECD TG 410 0, 100, 500 and 1000 mg/kg bw/day, 5 days/week for 21 days At 1000 mg/kg bw/day, ↑ incidence of local skin irritation in males and females; ↑ Incidence of hyperkeratosis and acanthosis in males and females. NOAEL (local toxicity): 100 mg/kg bw/day; NOAEL for (systemic toxicity): 1000 mg/kg bw/day Bomhard, 2002 in ECHA RAC, 2022; ECHA, 2023a/KL1","endpoint":"irritation","ingredient":"s, toys, textiles, clothing,","loael_value":"240 mg/kg bw/day","noael_unit":"mg/kg bw/day","noael_value":"100","page":69,"route":"dermal","species":"rat","study_id":"sccs_o_291_noael_041"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies irritation 1000 mg/kg bw/day rat dermal 21-day irritation SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=1000; DOSE=OECD TG 410 | 0, 100, 500 and 1000 mg/kg bw/day, 5 days/week for 21 days | At 1000 mg/kg bw/day, ↑ incidence of local skin irritation in males and females; ↑ Incidence of hyperkeratosis and acanthosis in males and females. | NOAEL (local toxicity):; EFFECT=Unlabeled table on page 69: 21-day dermal toxicity study in Fischer 344 rats (5/sex/group); OECD TG 410 | 0, 100, 500 and 1000 mg/kg bw/day, 5 days/week for 21 days | At 1000 mg/kg bw/day, ↑ incidence of local skin irritation in males and females; ↑ Incidence of hyperkeratosis and acanthosis in males and females. | NOAEL (local toxicity): 100 mg/kg bw/day; NOAEL for (systemic toxicity): 1000 mg/kg bw/day | Bomhard, 2002 in ECHA RAC, 2022; ECHA, 2023a/KL1; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"OECD TG 410 | 0, 100, 500 and 1000 mg/kg bw/day, 5 days/week for 21 days | At 1000 mg/kg bw/day, ↑ incidence of local skin irritation in males and females; ↑ Incidence of hyperkeratosis and acanthosis in males and females. | NOAEL (local toxicity):","duration":"21-day","effect":"Unlabeled table on page 69: 21-day dermal toxicity study in Fischer 344 rats (5/sex/group); OECD TG 410 | 0, 100, 500 and 1000 mg/kg bw/day, 5 days/week for 21 days | At 1000 mg/kg bw/day, ↑ incidence of local skin irritation in males and females; ↑ Incidence of hyperkeratosis and acanthosis in males and females. | NOAEL (local toxicity): 100 mg/kg bw/day; NOAEL for (systemic toxicity): 1000 mg/kg bw/day | Bomhard, 2002 in ECHA RAC, 2022; ECHA, 2023a/KL1","endpoint":"irritation","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"1000","page":69,"route":"dermal","species":"rat","study_id":"sccs_o_291_noael_112"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies irritation 100 mg/kg bw/day rat dermal 21-day irritation SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=100; DOSE=OECD TG 410 | 0, 100, 500 and 1000 mg/kg bw/day, 5 days/week for 21 days | At 1000 mg/kg bw/day, ↑ incidence of local skin irritation in males and females; ↑ Incidence of hyperkeratosis and acanthosis in males and females. | NOAEL (local toxicity):; EFFECT=Unlabeled table on page 69: 21-day dermal toxicity study in Fischer 344 rats (5/sex/group); OECD TG 410 | 0, 100, 500 and 1000 mg/kg bw/day, 5 days/week for 21 days | At 1000 mg/kg bw/day, ↑ incidence of local skin irritation in males and females; ↑ Incidence of hyperkeratosis and acanthosis in males and females. | NOAEL (local toxicity): 100 mg/kg bw/day; NOAEL for (systemic toxicity): 1000 mg/kg bw/day | Bomhard, 2002 in ECHA RAC, 2022; ECHA, 2023a/KL1; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"OECD TG 410 | 0, 100, 500 and 1000 mg/kg bw/day, 5 days/week for 21 days | At 1000 mg/kg bw/day, ↑ incidence of local skin irritation in males and females; ↑ Incidence of hyperkeratosis and acanthosis in males and females. | NOAEL (local toxicity):","duration":"21-day","effect":"Unlabeled table on page 69: 21-day dermal toxicity study in Fischer 344 rats (5/sex/group); OECD TG 410 | 0, 100, 500 and 1000 mg/kg bw/day, 5 days/week for 21 days | At 1000 mg/kg bw/day, ↑ incidence of local skin irritation in males and females; ↑ Incidence of hyperkeratosis and acanthosis in males and females. | NOAEL (local toxicity): 100 mg/kg bw/day; NOAEL for (systemic toxicity): 1000 mg/kg bw/day | Bomhard, 2002 in ECHA RAC, 2022; ECHA, 2023a/KL1","endpoint":"irritation","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"100","page":69,"route":"dermal","species":"rat","study_id":"sccs_o_291_noael_114"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 10000 mg/kg bw/day rat oral Sub-acute repeated dose toxicity SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=10000; DOSE=Repeated dose toxicity Oral repeated dose toxicity studies Study type, Species Doses Key findings NOAEL or LOAEL Reference#/ KL rating OPP Sub-acute studies 1-month dietary study in rats (strain not specified) (5 females/ group); no guideline 0, 2000, 3000, 4000, 5000 and 10000 mg/kg bw/day At 2000 mg/kg bw/day and slight growth retardation was...; LOAEL_VALUE=2000 mg/kg bw/day; EFFECT=SCCS/1669/24 Final version Opinion on the safety of Biphenyl-2-ol and Sodium 2-biphenylolate (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 65 9.4 ANNEX 4. Repeated dose toxicity Oral repeated dose toxicity studies Study type, Species Doses Key findings NOAEL or LOAEL Reference#/ KL rating OPP Sub-acute studies 1-month dietary study in rats (strain not specified) (5 females/ group); no guideline 0, 2000, 3000, 4000, 5000 and 10000 mg/kg bw/day At 2000 mg/kg bw/day and slight growth retardation was observed, all of the other dose groups lost weight rapidly. LOAEL: 2000 mg/kg bw/day Hodge et al., 1952 in (ECHA RAC, 2022)/KL2 32-day gavage study in male rats (15 males/ group); no guideline 0, 2, 20 and 200 mg/kg bw/day No treatment related adverse effects on any of parame; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"Repeated dose toxicity Oral repeated dose toxicity studies Study type, Species Doses Key findings NOAEL or LOAEL Reference#/ KL rating OPP Sub-acute studies 1-month dietary study in rats (strain not specified) (5 females/ group); no guideline 0, 2000, 3000, 4000, 5000 and 10000 mg/kg bw/day At 2000 mg/kg bw/day and slight growth retardation was...","duration":"Sub-acute","effect":"SCCS/1669/24 Final version Opinion on the safety of Biphenyl-2-ol and Sodium 2-biphenylolate (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 65 9.4 ANNEX 4. Repeated dose toxicity Oral repeated dose toxicity studies Study type, Species Doses Key findings NOAEL or LOAEL Reference#/ KL rating OPP Sub-acute studies 1-month dietary study in rats (strain not specified) (5 females/ group); no guideline 0, 2000, 3000, 4000, 5000 and 10000 mg/kg bw/day At 2000 mg/kg bw/day and slight growth retardation was observed, all of the other dose groups lost weight rapidly. LOAEL: 2000 mg/kg bw/day Hodge et al., 1952 in (ECHA RAC, 2022)/KL2 32-day gavage study in male rats (15 males/ group); no guideline 0, 2, 20 and 200 mg/kg bw/day No treatment related adverse effects on any of parame","endpoint":"repeated dose toxicity","ingredient":"s, toys, textiles, clothing,","loael_value":"2000 mg/kg bw/day","noael_unit":"mg/kg bw/day","noael_value":"10000","page":65,"route":"oral","species":"rat","study_id":"sccs_o_291_noael_023"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 200 mg/kg bw/day rat oral Sub-acute repeated dose toxicity SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=200; DOSE=rating OPP Sub-acute studies 1-month dietary study in rats (strain not specified) (5 females/ group); no guideline 0, 2000, 3000, 4000, 5000 and 10000 mg/kg bw/day At 2000 mg/kg bw/day and slight growth retardation was observed, all of the other dose groups lost weight rapidly.; LOAEL_VALUE=2000 mg/kg bw/day; EFFECT=rating OPP Sub-acute studies 1-month dietary study in rats (strain not specified) (5 females/ group); no guideline 0, 2000, 3000, 4000, 5000 and 10000 mg/kg bw/day At 2000 mg/kg bw/day and slight growth retardation was observed, all of the other dose groups lost weight rapidly. LOAEL: 2000 mg/kg bw/day Hodge et al., 1952 in (ECHA RAC, 2022)/KL2 32-day gavage study in male rats (15 males/ group); no guideline 0, 2, 20 and 200 mg/kg bw/day No treatment related adverse effects on any of parameters at any dose level. NOAEL: 200 mg/kg bw/day Macintosh, 1945 in (ECHA RAC, 2022)/KL2 13-day gavage study in New Zealand rabbits (2 females/ dose); similar to OECD 407 0, 100, 500 and 1000 mg/kg bw/day At 1000 mg/kg bw/day, ↓ final body weight, ↓ in food consumption was observed. At 500 mg/kg bw/day, changes in body weight, food consumption, absolute/relative, kidney and liver weight were observed. At 100 mg/kg bw/day, ↓ absolute/relative, liver weight. NOAEL: 100 mg/kg bw/day (ECHA, 2023b; ECHA RAC, 2022)/KL2 4-week gavage study in Beagle; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"rating OPP Sub-acute studies 1-month dietary study in rats (strain not specified) (5 females/ group); no guideline 0, 2000, 3000, 4000, 5000 and 10000 mg/kg bw/day At 2000 mg/kg bw/day and slight growth retardation was observed, all of the other dose groups lost weight rapidly.","duration":"Sub-acute","effect":"rating OPP Sub-acute studies 1-month dietary study in rats (strain not specified) (5 females/ group); no guideline 0, 2000, 3000, 4000, 5000 and 10000 mg/kg bw/day At 2000 mg/kg bw/day and slight growth retardation was observed, all of the other dose groups lost weight rapidly. LOAEL: 2000 mg/kg bw/day Hodge et al., 1952 in (ECHA RAC, 2022)/KL2 32-day gavage study in male rats (15 males/ group); no guideline 0, 2, 20 and 200 mg/kg bw/day No treatment related adverse effects on any of parameters at any dose level. NOAEL: 200 mg/kg bw/day Macintosh, 1945 in (ECHA RAC, 2022)/KL2 13-day gavage study in New Zealand rabbits (2 females/ dose); similar to OECD 407 0, 100, 500 and 1000 mg/kg bw/day At 1000 mg/kg bw/day, ↓ final body weight, ↓ in food consumption was observed. At 500 mg/kg bw/day, changes in body weight, food consumption, absolute/relative, kidney and liver weight were observed. At 100 mg/kg bw/day, ↓ absolute/relative, liver weight. NOAEL: 100 mg/kg bw/day (ECHA, 2023b; ECHA RAC, 2022)/KL2 4-week gavage study in Beagle","endpoint":"repeated dose toxicity","ingredient":"s, toys, textiles, clothing,","loael_value":"2000 mg/kg bw/day","noael_unit":"mg/kg bw/day","noael_value":"200","page":65,"route":"oral","species":"rat","study_id":"sccs_o_291_noael_024"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 2.5 % rat oral Sub-chronic repeated dose toxicity SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=2.5; DOSE=90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 66 Study type, Species Doses Key findings NOAEL or LOAEL Reference#/ KL rating Sub-chronic studie...; EFFECT=SCCS/1669/24 Final version Opinion on the safety of Biphenyl-2-ol and Sodium 2-biphenylolate (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 66 Study type, Species Doses Key findings NOAEL or LOAEL Reference#/ KL rating Sub-chronic studies 13-week dietary study in F344/DuCrj Rats (10/sex/group); similar to OECD TG 408 0, 0.156, 0.313, 0.625, 1.25, and 2.5% OPP equivalent to 0, 182, 391, 761, 1669, and 2798 mg/kg bw/day in males and 0, 202, 411, 803, 1650, and 3014 mg/kg bw/day in females At 2798/3014 mg/kg bw/day, ↓ body weight, terminal body weight, food and water consumption, changes in organ weight, and histopathological changes in the kidney and bladder, and ↓ Red Blood Count (RBC), Haemoglobin; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 66 Study type, Species Doses Key findings NOAEL or LOAEL Reference#/ KL rating Sub-chronic studie...","duration":"Sub-chronic","effect":"SCCS/1669/24 Final version Opinion on the safety of Biphenyl-2-ol and Sodium 2-biphenylolate (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 66 Study type, Species Doses Key findings NOAEL or LOAEL Reference#/ KL rating Sub-chronic studies 13-week dietary study in F344/DuCrj Rats (10/sex/group); similar to OECD TG 408 0, 0.156, 0.313, 0.625, 1.25, and 2.5% OPP equivalent to 0, 182, 391, 761, 1669, and 2798 mg/kg bw/day in males and 0, 202, 411, 803, 1650, and 3014 mg/kg bw/day in females At 2798/3014 mg/kg bw/day, ↓ body weight, terminal body weight, food and water consumption, changes in organ weight, and histopathological changes in the kidney and bladder, and ↓ Red Blood Count (RBC), Haemoglobin","endpoint":"repeated dose toxicity","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"%","noael_value":"2.5","page":66,"route":"oral","species":"rat","study_id":"sccs_o_291_noael_027"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 100 mg/kg bw/day rat oral 1 year repeated dose toxicity SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=100; DOSE=200 mg/kg bw/day Hodge et al., 1952 in (EC, 2023;; EFFECT=t in males (no numerical data) was observed. NOAEL: 200 mg/kg bw/day Hodge et al., 1952 in (EC, 2023; ECHA, 2023b; ECHA RAC, 2022)/KL2 1 year gavage study in Beagle dogs (4/sex/group); Similar to OECD TG 409 0, 30, 100, and 300 mg/kg bw/day At 300 mg/kg bw/day, ↓ terminal body weight in males, ↓ creatinine phosphokinase (CPK) in females and gross pathological changes such as dark regions in the pulmonary parenchyma, which is consistent with administration of test material into the lungs, resulting in anoxia/shock. NOAEL: 100 mg/kg bw/day Cosse et al. 1990 in (EC, 2023; ECHA, 2023b; ECHA RAC, 2022)/KL1 1-year dietary study (strain not specified) in dogs (1- 2/sex/group); Similar to OECD TG 409 0, 20, 200, and 500 mg/kg bw/day At 500 mg/kg bw/day, ↑ kidney weight in males (no numerical data) was observed. NOAEL: 200 mg/kg bw/day Hodge et al., 1952 in (EC, 2023; ECHA, 2023b; ECHA RAC, 2022)/KL2 SOPP Sub-acute studies 4-week dietary study in male F344 rats (group not specified); no guideline 0 and 2% (correspond- ding to a weighted a; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"200 mg/kg bw/day Hodge et al., 1952 in (EC, 2023;","duration":"1 year","effect":"t in males (no numerical data) was observed. NOAEL: 200 mg/kg bw/day Hodge et al., 1952 in (EC, 2023; ECHA, 2023b; ECHA RAC, 2022)/KL2 1 year gavage study in Beagle dogs (4/sex/group); Similar to OECD TG 409 0, 30, 100, and 300 mg/kg bw/day At 300 mg/kg bw/day, ↓ terminal body weight in males, ↓ creatinine phosphokinase (CPK) in females and gross pathological changes such as dark regions in the pulmonary parenchyma, which is consistent with administration of test material into the lungs, resulting in anoxia/shock. NOAEL: 100 mg/kg bw/day Cosse et al. 1990 in (EC, 2023; ECHA, 2023b; ECHA RAC, 2022)/KL1 1-year dietary study (strain not specified) in dogs (1- 2/sex/group); Similar to OECD TG 409 0, 20, 200, and 500 mg/kg bw/day At 500 mg/kg bw/day, ↑ kidney weight in males (no numerical data) was observed. NOAEL: 200 mg/kg bw/day Hodge et al., 1952 in (EC, 2023; ECHA, 2023b; ECHA RAC, 2022)/KL2 SOPP Sub-acute studies 4-week dietary study in male F344 rats (group not specified); no guideline 0 and 2% (correspond- ding to a weighted a","endpoint":"repeated dose toxicity","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"100","page":67,"route":"oral","species":"rat","study_id":"sccs_o_291_noael_033"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 200 mg/kg bw/day rat oral 1-year repeated dose toxicity SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=200; DOSE=100 mg/kg bw/day Cosse et al.; EFFECT=↓ creatinine phosphokinase (CPK) in females and gross pathological changes such as dark regions in the pulmonary parenchyma, which is consistent with administration of test material into the lungs, resulting in anoxia/shock. NOAEL: 100 mg/kg bw/day Cosse et al. 1990 in (EC, 2023; ECHA, 2023b; ECHA RAC, 2022)/KL1 1-year dietary study (strain not specified) in dogs (1- 2/sex/group); Similar to OECD TG 409 0, 20, 200, and 500 mg/kg bw/day At 500 mg/kg bw/day, ↑ kidney weight in males (no numerical data) was observed. NOAEL: 200 mg/kg bw/day Hodge et al., 1952 in (EC, 2023; ECHA, 2023b; ECHA RAC, 2022)/KL2 SOPP Sub-acute studies 4-week dietary study in male F344 rats (group not specified); no guideline 0 and 2% (correspond- ding to a weighted average dose of 2000 mg/kg bw/day) At 2000 mg/kg bw/day, an ↑ in dark- stained cells and a few mitoses were observed. The authors suggest that these changes are the prodromal stage of the tumours induced by SOPP after longer treatment periods. Only bladder examined (once/week by transmission ele; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"100 mg/kg bw/day Cosse et al.","duration":"1-year","effect":"↓ creatinine phosphokinase (CPK) in females and gross pathological changes such as dark regions in the pulmonary parenchyma, which is consistent with administration of test material into the lungs, resulting in anoxia/shock. NOAEL: 100 mg/kg bw/day Cosse et al. 1990 in (EC, 2023; ECHA, 2023b; ECHA RAC, 2022)/KL1 1-year dietary study (strain not specified) in dogs (1- 2/sex/group); Similar to OECD TG 409 0, 20, 200, and 500 mg/kg bw/day At 500 mg/kg bw/day, ↑ kidney weight in males (no numerical data) was observed. NOAEL: 200 mg/kg bw/day Hodge et al., 1952 in (EC, 2023; ECHA, 2023b; ECHA RAC, 2022)/KL2 SOPP Sub-acute studies 4-week dietary study in male F344 rats (group not specified); no guideline 0 and 2% (correspond- ding to a weighted average dose of 2000 mg/kg bw/day) At 2000 mg/kg bw/day, an ↑ in dark- stained cells and a few mitoses were observed. The authors suggest that these changes are the prodromal stage of the tumours induced by SOPP after longer treatment periods. Only bladder examined (once/week by transmission ele","endpoint":"repeated dose toxicity","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"200","page":67,"route":"oral","species":"rat","study_id":"sccs_o_291_noael_034"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 4294 mg/kg bw/day mouse oral Sub-chronic repeated dose toxicity SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=4294; DOSE=g bw/day) At 2000 mg/kg bw/day, an ↑ in dark- stained cells and a few mitoses were observed.; LOAEL_VALUE=2000 mg/kg bw/day; EFFECT=g bw/day) At 2000 mg/kg bw/day, an ↑ in dark- stained cells and a few mitoses were observed. The authors suggest that these changes are the prodromal stage of the tumours induced by SOPP after longer treatment periods. Only bladder examined (once/week by transmission electron microscopy (TEM). LOAEL: 2000 mg/kg bw/day Fukumori et al. in (SCCS, 2015)/KL2 Sub-chronic studies 13-week dietary study in B6C3F1 mice 0, 0.25, 0.5, 1.0, 2.0 and 4.0% (correspond- ding to At 5375/6349 mg/kg bw/day, ↓ body weight, ↓ mean food NOAEL: 3529 and 4294 mg/kg bw/day for males Shibata et al., 1981, 1985 in (SCCS, 2015)/KL2; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"g bw/day) At 2000 mg/kg bw/day, an ↑ in dark- stained cells and a few mitoses were observed.","duration":"Sub-chronic","effect":"g bw/day) At 2000 mg/kg bw/day, an ↑ in dark- stained cells and a few mitoses were observed. The authors suggest that these changes are the prodromal stage of the tumours induced by SOPP after longer treatment periods. Only bladder examined (once/week by transmission electron microscopy (TEM). LOAEL: 2000 mg/kg bw/day Fukumori et al. in (SCCS, 2015)/KL2 Sub-chronic studies 13-week dietary study in B6C3F1 mice 0, 0.25, 0.5, 1.0, 2.0 and 4.0% (correspond- ding to At 5375/6349 mg/kg bw/day, ↓ body weight, ↓ mean food NOAEL: 3529 and 4294 mg/kg bw/day for males Shibata et al., 1981, 1985 in (SCCS, 2015)/KL2","endpoint":"repeated dose toxicity","ingredient":"s, toys, textiles, clothing,","loael_value":"2000 mg/kg bw/day","noael_unit":"mg/kg bw/day","noael_value":"4294","page":67,"route":"oral","species":"mouse","study_id":"sccs_o_291_noael_035"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 1865 mg/kg bw/day mouse dermal 4-week repeated dose toxicity SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=1865; DOSE=90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 69 Dermal repeated dose toxicity studies Study type, Species Doses Key findings NOAEL or LOAEL Re...; EFFECT=SCCS/1669/24 Final version Opinion on the safety of Biphenyl-2-ol and Sodium 2-biphenylolate (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 69 Dermal repeated dose toxicity studies Study type, Species Doses Key findings NOAEL or LOAEL Reference#/ KL rating OPP 4-week dermal toxicity study in Swiss Webster CFW mice (10/sex/group); no guideline 0, 5.95, 11.4, 20.8, 35.7 and 55.5 mg / 0.1 mL acetone (corresponding to weighted average doses of 0, 383.1, 699.08, 1200 and 1865 mg/kg bw/day for males 0, 460.21, 839.70, 1441.20 and 2240.53 mg/kg bw/day for females respectively) 3 days/week Ulcerative lesions at the site of application were observed in all mice that received ≤20.8 mg; in 6/10 males and 9/10 females that received 11.4 mg; in 2/1; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 69 Dermal repeated dose toxicity studies Study type, Species Doses Key findings NOAEL or LOAEL Re...","duration":"4-week","effect":"SCCS/1669/24 Final version Opinion on the safety of Biphenyl-2-ol and Sodium 2-biphenylolate (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 69 Dermal repeated dose toxicity studies Study type, Species Doses Key findings NOAEL or LOAEL Reference#/ KL rating OPP 4-week dermal toxicity study in Swiss Webster CFW mice (10/sex/group); no guideline 0, 5.95, 11.4, 20.8, 35.7 and 55.5 mg / 0.1 mL acetone (corresponding to weighted average doses of 0, 383.1, 699.08, 1200 and 1865 mg/kg bw/day for males 0, 460.21, 839.70, 1441.20 and 2240.53 mg/kg bw/day for females respectively) 3 days/week Ulcerative lesions at the site of application were observed in all mice that received ≤20.8 mg; in 6/10 males and 9/10 females that received 11.4 mg; in 2/1","endpoint":"repeated dose toxicity","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"1865","page":69,"route":"dermal","species":"mouse","study_id":"sccs_o_291_noael_039"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies reproductive toxicity 39 mg/kg bw/d rat oral 2-year reproductive toxicity SOURCE_SUBDIR=sccs_o_177; REPORT_TITLE=OPINION ON o-Phenylphenol, Sodium o-phenylphenate and Potassium o-phenylphenate; OPINION_NUMBER=SCCS/1555/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=15 December 2015; VALUE_TEXT=39; DOSE=303), a NOAEL of 39 mg/kg bw/d was obtained based on urinary bladder hyperplasia and urinary bladder transitional cell carcinoma.; EFFECT=OPP) • Species- and strain-specific differences (OPP-induced bladder tumours were not observed in female rats, mice, dogs) • dermal application to mice does not affect tumour incidence in skin • no skin tumour development induced by OPP metabolites • tumours occur at high doses when sulfate and glucuronide conjugation pathways are saturated The threshold for OPP-induced bladder tumours can be approached from different studies all yielding a quite consistent picture: In a 2-year bioassay in F344 rats (Ref. 303), a NOAEL of 39 mg/kg bw/d was obtained based on urinary bladder hyperplasia and urinary bladder transitional cell carcinoma. In a study investigating cytotoxicity and regenerative hyperplasia in male F344 rats fed different levels of OPP (Ref. 263), no effects were observed at a dose level of 0.08 % OPP in diet (corresponding to approximately 40 mg/kg bw/d). In a 2-generation reproductive toxicity study (see section 3.3.8.1) performed in Sprague-Dawley rats, a NOAEL of 35 mg/kg bw/d was identified based on morphological ch; CITATION=(Ref. 303); CITATION_NUMBERS=[303]; REFERENCE=(Ref. 303); DETAILS_JSON={"cas_number":"90-43-7","citation":"(Ref. 303)","dose":"303), a NOAEL of 39 mg/kg bw/d was obtained based on urinary bladder hyperplasia and urinary bladder transitional cell carcinoma.","duration":"2-year","effect":"OPP) • Species- and strain-specific differences (OPP-induced bladder tumours were not observed in female rats, mice, dogs) • dermal application to mice does not affect tumour incidence in skin • no skin tumour development induced by OPP metabolites • tumours occur at high doses when sulfate and glucuronide conjugation pathways are saturated The threshold for OPP-induced bladder tumours can be approached from different studies all yielding a quite consistent picture: In a 2-year bioassay in F344 rats (Ref. 303), a NOAEL of 39 mg/kg bw/d was obtained based on urinary bladder hyperplasia and urinary bladder transitional cell carcinoma. In a study investigating cytotoxicity and regenerative hyperplasia in male F344 rats fed different levels of OPP (Ref. 263), no effects were observed at a dose level of 0.08 % OPP in diet (corresponding to approximately 40 mg/kg bw/d). In a 2-generation reproductive toxicity study (see section 3.3.8.1) performed in Sprague-Dawley rats, a NOAEL of 35 mg/kg bw/d was identified based on morphological ch","endpoint":"reproductive toxicity","ingredient":"codes.................................... 9","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"39","page":32,"route":"oral","species":"rat","study_id":"sccs_o_177_noael_005"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies reproductive toxicity 35 mg/kg bw/d rat oral 2-year reproductive toxicity SOURCE_SUBDIR=sccs_o_177; REPORT_TITLE=OPINION ON o-Phenylphenol, Sodium o-phenylphenate and Potassium o-phenylphenate; OPINION_NUMBER=SCCS/1555/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=15 December 2015; VALUE_TEXT=35; DOSE=303), a NOAEL of 39 mg/kg bw/d was obtained based on urinary bladder hyperplasia and urinary bladder transitional cell carcinoma.; EFFECT=picture: In a 2-year bioassay in F344 rats (Ref. 303), a NOAEL of 39 mg/kg bw/d was obtained based on urinary bladder hyperplasia and urinary bladder transitional cell carcinoma. In a study investigating cytotoxicity and regenerative hyperplasia in male F344 rats fed different levels of OPP (Ref. 263), no effects were observed at a dose level of 0.08 % OPP in diet (corresponding to approximately 40 mg/kg bw/d). In a 2-generation reproductive toxicity study (see section 3.3.8.1) performed in Sprague-Dawley rats, a NOAEL of 35 mg/kg bw/d was identified based on morphological changes in the urinary bladder (Ref. 36). SCCS conclusions on chronic toxicity and carcinogenicity The urinary bladder and kidneys of rats are the main target tissues after chronic administration of OPP and SOPP. OPP and SOPP resulted in urinary bladder tumours (papilloma and carcinoma, mainly transitional cell papilloma and carcinoma) in male F344 rats. At higher doses, also the renal pelvis and the renal papilla are target tissues for OPP- and SOPP toxicity; CITATION=(Ref. 303); CITATION_NUMBERS=[303]; REFERENCE=(Ref. 303); DETAILS_JSON={"cas_number":"90-43-7","citation":"(Ref. 303)","dose":"303), a NOAEL of 39 mg/kg bw/d was obtained based on urinary bladder hyperplasia and urinary bladder transitional cell carcinoma.","duration":"2-year","effect":"picture: In a 2-year bioassay in F344 rats (Ref. 303), a NOAEL of 39 mg/kg bw/d was obtained based on urinary bladder hyperplasia and urinary bladder transitional cell carcinoma. In a study investigating cytotoxicity and regenerative hyperplasia in male F344 rats fed different levels of OPP (Ref. 263), no effects were observed at a dose level of 0.08 % OPP in diet (corresponding to approximately 40 mg/kg bw/d). In a 2-generation reproductive toxicity study (see section 3.3.8.1) performed in Sprague-Dawley rats, a NOAEL of 35 mg/kg bw/d was identified based on morphological changes in the urinary bladder (Ref. 36). SCCS conclusions on chronic toxicity and carcinogenicity The urinary bladder and kidneys of rats are the main target tissues after chronic administration of OPP and SOPP. OPP and SOPP resulted in urinary bladder tumours (papilloma and carcinoma, mainly transitional cell papilloma and carcinoma) in male F344 rats. At higher doses, also the renal pelvis and the renal papilla are target tissues for OPP- and SOPP toxicity","endpoint":"reproductive toxicity","ingredient":"codes.................................... 9","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"35","page":32,"route":"oral","species":"rat","study_id":"sccs_o_177_noael_006"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies reproductive toxicity 457 mg/kg rat - - reproductive toxicity SOURCE_SUBDIR=sccs_o_177; REPORT_TITLE=OPINION ON o-Phenylphenol, Sodium o-phenylphenate and Potassium o-phenylphenate; OPINION_NUMBER=SCCS/1555/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=15 December 2015; VALUE_TEXT=457; DOSE=The incidence of calculi in the kidney and/or urinary bladder was increased in male P and F1 rats at 125 and 457 mg/kg.; EFFECT=and F1 adults. The incidence of calculi in the kidney and/or urinary bladder was increased in male P and F1 rats at 125 and 457 mg/kg. Transitional cell hyperplasia/papillomatosis in the urinary bladder was diagnosed in 457 mg/kg P males and females and in 457 mg/kg F1 males. Morphometry measurements confirmed the microscopic findings at 457 mg/kg and indicated a compound-related effect also in 125 mg/kg P males and females. No embryotoxic or teratogenic effects were observed at doses up to 457 mg/kg. The overall NOAEL for the adults, based on morphological changes, was considered as 35 mg/kg. Ref.: 36 SCCS comment SCCS notes that based on deviations from the Guideline protocol, Kwock and Silva (2013) stated that assessments on fertility in that study were inconclusive. Guideline: OECD TG 416 Species/strain: rat, CD Sprague-Dawley Group size: 30/sex/dose Test substance: OPP, technical grade Batch: S-01-93 (mixture of OPP from Dow and Bayer) Purity: 99.5 – 100 % Vehicle: / Dose levels: 0, 20, 100, 500 mg/kg bw/d Dose volume: /; CITATION=Ref.: 36 SCCS comment SCCS notes that based on deviations from the Guideline protocol, Kwock and Silva (2013) stated that assessments on fertility in that study were inconclusive; CITATION_NUMBERS=[36,2013]; REFERENCE=Ref.: 36 SCCS comment SCCS notes that based on deviations from the Guideline protocol, Kwock and Silva (2013) stated that assessments on fertility in that study were inconclusive; DETAILS_JSON={"cas_number":"90-43-7","citation":"Ref.: 36 SCCS comment SCCS notes that based on deviations from the Guideline protocol, Kwock and Silva (2013) stated that assessments on fertility in that study were inconclusive","dose":"The incidence of calculi in the kidney and/or urinary bladder was increased in male P and F1 rats at 125 and 457 mg/kg.","duration":"","effect":"and F1 adults. The incidence of calculi in the kidney and/or urinary bladder was increased in male P and F1 rats at 125 and 457 mg/kg. Transitional cell hyperplasia/papillomatosis in the urinary bladder was diagnosed in 457 mg/kg P males and females and in 457 mg/kg F1 males. Morphometry measurements confirmed the microscopic findings at 457 mg/kg and indicated a compound-related effect also in 125 mg/kg P males and females. No embryotoxic or teratogenic effects were observed at doses up to 457 mg/kg. The overall NOAEL for the adults, based on morphological changes, was considered as 35 mg/kg. Ref.: 36 SCCS comment SCCS notes that based on deviations from the Guideline protocol, Kwock and Silva (2013) stated that assessments on fertility in that study were inconclusive. Guideline: OECD TG 416 Species/strain: rat, CD Sprague-Dawley Group size: 30/sex/dose Test substance: OPP, technical grade Batch: S-01-93 (mixture of OPP from Dow and Bayer) Purity: 99.5 – 100 % Vehicle: / Dose levels: 0, 20, 100, 500 mg/kg bw/d Dose volume: /","endpoint":"reproductive toxicity","ingredient":"codes.................................... 9","loael_value":"","noael_unit":"mg/kg","noael_value":"457","page":33,"route":"","species":"rat","study_id":"sccs_o_177_noael_007"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies reproductive toxicity 500 mg/kg bw/d - - chronic reproductive toxicity SOURCE_SUBDIR=sccs_o_177; REPORT_TITLE=OPINION ON o-Phenylphenol, Sodium o-phenylphenate and Potassium o-phenylphenate; OPINION_NUMBER=SCCS/1555/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=15 December 2015; VALUE_TEXT=500; DOSE=, and an increased severity of background lesions in the kidneys, transitional cell hyperplasia (simple and/or nodular/papillary), calculi, and chronic inflammation in the urinary bladder as well as dilatation and hyperplasia of the ureter in P and F1 males at 500 mg/kg.; EFFECT=, and an increased severity of background lesions in the kidneys, transitional cell hyperplasia (simple and/or nodular/papillary), calculi, and chronic inflammation in the urinary bladder as well as dilatation and hyperplasia of the ureter in P and F1 males at 500 mg/kg. There were no effects on adult reproductive parameters. Pup weights were lower at 500 mg/kg bw/d. No effects were seen on litter size, gender distribution, number of stillborn, viability, clinical signs or gross pathology of pups. The reproductive NOAEL in this study was considered to be 500 mg/kg bw/d. The parental and neonatal NOAEL was considered to be 100 mg/kg based on decreased body weights, decreased pup weights and morphologic lesions in kidneys, urinary bladder and urether at 500 mg/kg bw/d. Ref.:37, 38 SCCS comment Some important reprotoxic parameters (e.g. sperm parameters, yellow bodies, weight of some reproductive organs) were not assessed in this study. 3.3.8.2 Other data on fertility and reproduction toxicity / 3.3.8.3 Developmental Toxicity R; CITATION=Ref.:37, 38 SCCS comment Some important reprotoxic parameters (e; CITATION_NUMBERS=[37,38]; REFERENCE=Ref.:37, 38 SCCS comment Some important reprotoxic parameters (e; DETAILS_JSON={"cas_number":"90-43-7","citation":"Ref.:37, 38 SCCS comment Some important reprotoxic parameters (e","dose":", and an increased severity of background lesions in the kidneys, transitional cell hyperplasia (simple and/or nodular/papillary), calculi, and chronic inflammation in the urinary bladder as well as dilatation and hyperplasia of the ureter in P and F1 males at 500 mg/kg.","duration":"chronic","effect":", and an increased severity of background lesions in the kidneys, transitional cell hyperplasia (simple and/or nodular/papillary), calculi, and chronic inflammation in the urinary bladder as well as dilatation and hyperplasia of the ureter in P and F1 males at 500 mg/kg. There were no effects on adult reproductive parameters. Pup weights were lower at 500 mg/kg bw/d. No effects were seen on litter size, gender distribution, number of stillborn, viability, clinical signs or gross pathology of pups. The reproductive NOAEL in this study was considered to be 500 mg/kg bw/d. The parental and neonatal NOAEL was considered to be 100 mg/kg based on decreased body weights, decreased pup weights and morphologic lesions in kidneys, urinary bladder and urether at 500 mg/kg bw/d. Ref.:37, 38 SCCS comment Some important reprotoxic parameters (e.g. sperm parameters, yellow bodies, weight of some reproductive organs) were not assessed in this study. 3.3.8.2 Other data on fertility and reproduction toxicity / 3.3.8.3 Developmental Toxicity R","endpoint":"reproductive toxicity","ingredient":"codes.................................... 9","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"500","page":34,"route":"","species":"","study_id":"sccs_o_177_noael_008"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies reproductive toxicity 100 mg/kg rabbit - chronic reproductive toxicity SOURCE_SUBDIR=sccs_o_177; REPORT_TITLE=OPINION ON o-Phenylphenol, Sodium o-phenylphenate and Potassium o-phenylphenate; OPINION_NUMBER=SCCS/1555/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=15 December 2015; VALUE_TEXT=100; DOSE=hyperplasia (simple and/or nodular/papillary), calculi, and chronic inflammation in the urinary bladder as well as dilatation and hyperplasia of the ureter in P and F1 males at 500 mg/kg.; EFFECT=hyperplasia (simple and/or nodular/papillary), calculi, and chronic inflammation in the urinary bladder as well as dilatation and hyperplasia of the ureter in P and F1 males at 500 mg/kg. There were no effects on adult reproductive parameters. Pup weights were lower at 500 mg/kg bw/d. No effects were seen on litter size, gender distribution, number of stillborn, viability, clinical signs or gross pathology of pups. The reproductive NOAEL in this study was considered to be 500 mg/kg bw/d. The parental and neonatal NOAEL was considered to be 100 mg/kg based on decreased body weights, decreased pup weights and morphologic lesions in kidneys, urinary bladder and urether at 500 mg/kg bw/d. Ref.:37, 38 SCCS comment Some important reprotoxic parameters (e.g. sperm parameters, yellow bodies, weight of some reproductive organs) were not assessed in this study. 3.3.8.2 Other data on fertility and reproduction toxicity / 3.3.8.3 Developmental Toxicity Rabbits Guideline: OECD TG 414 Species/strain: Female rabbit, White New Zealand Gro; CITATION=Ref.:37, 38 SCCS comment Some important reprotoxic parameters (e; CITATION_NUMBERS=[37,38]; REFERENCE=Ref.:37, 38 SCCS comment Some important reprotoxic parameters (e; DETAILS_JSON={"cas_number":"90-43-7","citation":"Ref.:37, 38 SCCS comment Some important reprotoxic parameters (e","dose":"hyperplasia (simple and/or nodular/papillary), calculi, and chronic inflammation in the urinary bladder as well as dilatation and hyperplasia of the ureter in P and F1 males at 500 mg/kg.","duration":"chronic","effect":"hyperplasia (simple and/or nodular/papillary), calculi, and chronic inflammation in the urinary bladder as well as dilatation and hyperplasia of the ureter in P and F1 males at 500 mg/kg. There were no effects on adult reproductive parameters. Pup weights were lower at 500 mg/kg bw/d. No effects were seen on litter size, gender distribution, number of stillborn, viability, clinical signs or gross pathology of pups. The reproductive NOAEL in this study was considered to be 500 mg/kg bw/d. The parental and neonatal NOAEL was considered to be 100 mg/kg based on decreased body weights, decreased pup weights and morphologic lesions in kidneys, urinary bladder and urether at 500 mg/kg bw/d. Ref.:37, 38 SCCS comment Some important reprotoxic parameters (e.g. sperm parameters, yellow bodies, weight of some reproductive organs) were not assessed in this study. 3.3.8.2 Other data on fertility and reproduction toxicity / 3.3.8.3 Developmental Toxicity Rabbits Guideline: OECD TG 414 Species/strain: Female rabbit, White New Zealand Gro","endpoint":"reproductive toxicity","ingredient":"codes.................................... 9","loael_value":"","noael_unit":"mg/kg","noael_value":"100","page":34,"route":"","species":"rabbit","study_id":"sccs_o_177_noael_009"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies reproductive toxicity 100 mg/kg bw rat - developmental reproductive toxicity SOURCE_SUBDIR=sccs_o_177; REPORT_TITLE=OPINION ON o-Phenylphenol, Sodium o-phenylphenate and Potassium o-phenylphenate; OPINION_NUMBER=SCCS/1555/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=15 December 2015; VALUE_TEXT=100; DOSE=No adverse effects of OPP on foetuses of rabbits were observed, however, there were increased incidences of resorptions independent from maternal toxicity, leading to a developmental NOAEL of 25 mg/kg bw/d.; LOAEL_VALUE=1450 mg/kg bw/d; EFFECT=n investigated in rabbits, rats and mice and there is a report on developmental toxicity of SOPP in mice. No adverse effects of OPP on foetuses of rabbits were observed, however, there were increased incidences of resorptions independent from maternal toxicity, leading to a developmental NOAEL of 25 mg/kg bw/d. An increased incidence of resorption was also reported from developmental toxicity studies performed with OPP in rats. The lowest maternal NOAEL of OPP identified in rats was 100 mg/kg bw whereas the lowest NOAEL for development identified in rats was 300 mg/kg bw/d. In mice treated with comparably high doses of OPP, maternal and developmental effects were observed at all concentrations tested and an LOAEL of 1450 mg/kg bw/d was identified. In mice treated with SOPP, developmental effects (reduced foetal weight and increased incidence of cleft palate) could be observed at the lowest dose tested (100 mg/kg bw/d). As a summary, whereas OPP does not adversely affect fertility or reproductive; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"No adverse effects of OPP on foetuses of rabbits were observed, however, there were increased incidences of resorptions independent from maternal toxicity, leading to a developmental NOAEL of 25 mg/kg bw/d.","duration":"developmental","effect":"n investigated in rabbits, rats and mice and there is a report on developmental toxicity of SOPP in mice. No adverse effects of OPP on foetuses of rabbits were observed, however, there were increased incidences of resorptions independent from maternal toxicity, leading to a developmental NOAEL of 25 mg/kg bw/d. An increased incidence of resorption was also reported from developmental toxicity studies performed with OPP in rats. The lowest maternal NOAEL of OPP identified in rats was 100 mg/kg bw whereas the lowest NOAEL for development identified in rats was 300 mg/kg bw/d. In mice treated with comparably high doses of OPP, maternal and developmental effects were observed at all concentrations tested and an LOAEL of 1450 mg/kg bw/d was identified. In mice treated with SOPP, developmental effects (reduced foetal weight and increased incidence of cleft palate) could be observed at the lowest dose tested (100 mg/kg bw/d). As a summary, whereas OPP does not adversely affect fertility or reproductive","endpoint":"reproductive toxicity","ingredient":"codes.................................... 9","loael_value":"1450 mg/kg bw/d","noael_unit":"mg/kg bw","noael_value":"100","page":37,"route":"","species":"rat","study_id":"sccs_o_177_noael_019"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies reproductive toxicity 39 mg/kg bw/d rat oral 2-year reproductive toxicity SOURCE_SUBDIR=sccs_o_177; REPORT_TITLE=OPINION ON o-Phenylphenol, Sodium o-phenylphenate and Potassium o-phenylphenate; OPINION_NUMBER=SCCS/1555/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=15 December 2015; VALUE_TEXT=39; DOSE=There is insufficient dose-response data available to draw a conclusion on the possibility of setting a threshold for SOPP-induced carcinogenicity.; EFFECT=her urinary pH. The carcinogenic potential of SOPP is higher when compared to OPP and in contrast to OPP; SOPP has been shown to possess initiating and promoting properties (in contrast to OPP). There is insufficient dose-response data available to draw a conclusion on the possibility of setting a threshold for SOPP-induced carcinogenicity. The threshold for OPP induced bladder tumours can be approached from different studies all yielding a quite consistent picture: In a 2-year bioassay in F344 rats (Ref. 303), a NOAEL of 39 mg/kg bw/d was obtained based on urinary bladder hyperplasia and urinary bladder transitional cell carcinoma. In a study investigating cytotoxicity and regenerative hyperplasia in male F344 rats fed different levels of OPP (Ref. 263), no effects were observed at a dose level of 0.08 % OPP in diet (corresponding to approximately 40 mg/kg bw/d). In a 2-generation reproductive toxicity study performed in Sprague-Dawley rats, a NOAEL of 35 mg/kg bw/d was identified based on morphological changes in the urinary b; CITATION=(Ref. 303); CITATION_NUMBERS=[303]; REFERENCE=(Ref. 303); DETAILS_JSON={"cas_number":"90-43-7","citation":"(Ref. 303)","dose":"There is insufficient dose-response data available to draw a conclusion on the possibility of setting a threshold for SOPP-induced carcinogenicity.","duration":"2-year","effect":"her urinary pH. The carcinogenic potential of SOPP is higher when compared to OPP and in contrast to OPP; SOPP has been shown to possess initiating and promoting properties (in contrast to OPP). There is insufficient dose-response data available to draw a conclusion on the possibility of setting a threshold for SOPP-induced carcinogenicity. The threshold for OPP induced bladder tumours can be approached from different studies all yielding a quite consistent picture: In a 2-year bioassay in F344 rats (Ref. 303), a NOAEL of 39 mg/kg bw/d was obtained based on urinary bladder hyperplasia and urinary bladder transitional cell carcinoma. In a study investigating cytotoxicity and regenerative hyperplasia in male F344 rats fed different levels of OPP (Ref. 263), no effects were observed at a dose level of 0.08 % OPP in diet (corresponding to approximately 40 mg/kg bw/d). In a 2-generation reproductive toxicity study performed in Sprague-Dawley rats, a NOAEL of 35 mg/kg bw/d was identified based on morphological changes in the urinary b","endpoint":"reproductive toxicity","ingredient":"codes.................................... 9","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"39","page":46,"route":"oral","species":"rat","study_id":"sccs_o_177_noael_021"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies reproductive toxicity 35 mg/kg bw/d rat oral 2-year reproductive toxicity SOURCE_SUBDIR=sccs_o_177; REPORT_TITLE=OPINION ON o-Phenylphenol, Sodium o-phenylphenate and Potassium o-phenylphenate; OPINION_NUMBER=SCCS/1555/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=15 December 2015; VALUE_TEXT=35; DOSE=303), a NOAEL of 39 mg/kg bw/d was obtained based on urinary bladder hyperplasia and urinary bladder transitional cell carcinoma.; EFFECT=ing a quite consistent picture: In a 2-year bioassay in F344 rats (Ref. 303), a NOAEL of 39 mg/kg bw/d was obtained based on urinary bladder hyperplasia and urinary bladder transitional cell carcinoma. In a study investigating cytotoxicity and regenerative hyperplasia in male F344 rats fed different levels of OPP (Ref. 263), no effects were observed at a dose level of 0.08 % OPP in diet (corresponding to approximately 40 mg/kg bw/d). In a 2-generation reproductive toxicity study performed in Sprague-Dawley rats, a NOAEL of 35 mg/kg bw/d was identified based on morphological changes in the urinary bladder (Ref. 36).; CITATION=(Ref. 303); CITATION_NUMBERS=[303]; REFERENCE=(Ref. 303); DETAILS_JSON={"cas_number":"90-43-7","citation":"(Ref. 303)","dose":"303), a NOAEL of 39 mg/kg bw/d was obtained based on urinary bladder hyperplasia and urinary bladder transitional cell carcinoma.","duration":"2-year","effect":"ing a quite consistent picture: In a 2-year bioassay in F344 rats (Ref. 303), a NOAEL of 39 mg/kg bw/d was obtained based on urinary bladder hyperplasia and urinary bladder transitional cell carcinoma. In a study investigating cytotoxicity and regenerative hyperplasia in male F344 rats fed different levels of OPP (Ref. 263), no effects were observed at a dose level of 0.08 % OPP in diet (corresponding to approximately 40 mg/kg bw/d). In a 2-generation reproductive toxicity study performed in Sprague-Dawley rats, a NOAEL of 35 mg/kg bw/d was identified based on morphological changes in the urinary bladder (Ref. 36).","endpoint":"reproductive toxicity","ingredient":"codes.................................... 9","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"35","page":46,"route":"oral","species":"rat","study_id":"sccs_o_177_noael_022"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies reproductive toxicity 100 mg/kg bw rat - developmental reproductive toxicity SOURCE_SUBDIR=sccs_o_177; REPORT_TITLE=OPINION ON o-Phenylphenol, Sodium o-phenylphenate and Potassium o-phenylphenate; OPINION_NUMBER=SCCS/1555/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=15 December 2015; VALUE_TEXT=100; DOSE=No adverse effects of OPP on foetuses of rabbits were observed, however, there were increased incidences of resorptions independent from maternal toxicity, leading to a developmental NOAEL of 25 mg/kg bw/d.; LOAEL_VALUE=1450 mg/kg bw/d; EFFECT=investigated in rabbits, rats and mice and there is a report on developmental toxicity of SOPP in mice. No adverse effects of OPP on foetuses of rabbits were observed, however, there were increased incidences of resorptions independent from maternal toxicity, leading to a developmental NOAEL of 25 mg/kg bw/d. An increased incidence of resorption was also reported from developmental toxicity studies performed with OPP in rats. The lowest maternal NOAEL of OPP identified in rats was 100 mg/kg bw, whereas the lowest NOAEL for development identified in rats was 300 mg/kg bw/d. In mice treated with comparably high doses of OPP, maternal and developmental effects were observed at all concentrations tested and an LOAEL of 1450 mg/kg bw/d was identified. In mice treated with SOPP, developmental effects (reduced foetal weight and increased incidence of cleft palate) could be observed at the lowest dose tested (100 mg/kg bw/d). As a summary, whereas OPP does not adversely affect fertility and reproductive organs, increased incidence of re; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"No adverse effects of OPP on foetuses of rabbits were observed, however, there were increased incidences of resorptions independent from maternal toxicity, leading to a developmental NOAEL of 25 mg/kg bw/d.","duration":"developmental","effect":"investigated in rabbits, rats and mice and there is a report on developmental toxicity of SOPP in mice. No adverse effects of OPP on foetuses of rabbits were observed, however, there were increased incidences of resorptions independent from maternal toxicity, leading to a developmental NOAEL of 25 mg/kg bw/d. An increased incidence of resorption was also reported from developmental toxicity studies performed with OPP in rats. The lowest maternal NOAEL of OPP identified in rats was 100 mg/kg bw, whereas the lowest NOAEL for development identified in rats was 300 mg/kg bw/d. In mice treated with comparably high doses of OPP, maternal and developmental effects were observed at all concentrations tested and an LOAEL of 1450 mg/kg bw/d was identified. In mice treated with SOPP, developmental effects (reduced foetal weight and increased incidence of cleft palate) could be observed at the lowest dose tested (100 mg/kg bw/d). As a summary, whereas OPP does not adversely affect fertility and reproductive organs, increased incidence of re","endpoint":"reproductive toxicity","ingredient":"codes.................................... 9","loael_value":"1450 mg/kg bw/d","noael_unit":"mg/kg bw","noael_value":"100","page":50,"route":"","species":"rat","study_id":"sccs_o_177_noael_030"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies reproductive toxicity 25 mg/kg bw/d mouse oral developmental reproductive toxicity SOURCE_SUBDIR=sccs_o_177; REPORT_TITLE=OPINION ON o-Phenylphenol, Sodium o-phenylphenate and Potassium o-phenylphenate; OPINION_NUMBER=SCCS/1555/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=15 December 2015; VALUE_TEXT=25; DOSE=es of OPP, maternal and developmental effects were observed at all concentrations tested and an LOAEL of 1450 mg/kg bw/d was identified.; LOAEL_VALUE=1450 mg/kg bw/d; EFFECT=es of OPP, maternal and developmental effects were observed at all concentrations tested and an LOAEL of 1450 mg/kg bw/d was identified. In mice treated with SOPP, developmental effects (reduced foetal weight and increased incidence of cleft palate) could be observed at the lowest dose tested (100 mg/kg bw/d). As a summary, whereas OPP does not adversely affect fertility and reproductive organs, increased incidence of resorptions can be considered as a developmental effect of OPP and SOPP. The lowest developmental NOAEL identified was 25 mg/kg bw/d, which was taken for MOS calculation. Toxicokinetics Toxicokinetic data demonstrate that it is justified to assume 100 % oral absorption for MoS calculation, i.e. no correction for oral absorption. Further, toxicokinetic data demonstrate, that OPP and SOPP and their metabolites are mainly excreted in conjugated form (sulfates and glucuronides). Free metabolites occur in urine mainly at higher dosages. It is hypothesised that species generated by (aut)oxidation of free PHQ are responsi; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"es of OPP, maternal and developmental effects were observed at all concentrations tested and an LOAEL of 1450 mg/kg bw/d was identified.","duration":"developmental","effect":"es of OPP, maternal and developmental effects were observed at all concentrations tested and an LOAEL of 1450 mg/kg bw/d was identified. In mice treated with SOPP, developmental effects (reduced foetal weight and increased incidence of cleft palate) could be observed at the lowest dose tested (100 mg/kg bw/d). As a summary, whereas OPP does not adversely affect fertility and reproductive organs, increased incidence of resorptions can be considered as a developmental effect of OPP and SOPP. The lowest developmental NOAEL identified was 25 mg/kg bw/d, which was taken for MOS calculation. Toxicokinetics Toxicokinetic data demonstrate that it is justified to assume 100 % oral absorption for MoS calculation, i.e. no correction for oral absorption. Further, toxicokinetic data demonstrate, that OPP and SOPP and their metabolites are mainly excreted in conjugated form (sulfates and glucuronides). Free metabolites occur in urine mainly at higher dosages. It is hypothesised that species generated by (aut)oxidation of free PHQ are responsi","endpoint":"reproductive toxicity","ingredient":"codes.................................... 9","loael_value":"1450 mg/kg bw/d","noael_unit":"mg/kg bw/d","noael_value":"25","page":50,"route":"oral","species":"mouse","study_id":"sccs_o_177_noael_031"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies reproductive toxicity 25 mg/kg bw/day rabbit - developmental reproductive toxicity SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=25; DOSE=ncreased incidence of cleft palate, were observed even at the lowest dose tested (100 mg/kg bw/day).; EFFECT=SCCS-rejected applicant NOAEL: ncreased incidence of cleft palate, were observed even at the lowest dose tested (100 mg/kg bw/day). The only developmental toxicity study with SOPP, is not considered to be useful in safety assessment due to design and reporting limitations. However, it did suggest SOPP's potential interference with rodent development. In summary, while OPP did not adversely affect fertility or reproductive organs, the increased incidence of resorptions can be considered a developmental effect of both OPP and SOPP with a critical NOAEL of 25 mg/kg bw/day. SCCS comment on developmental toxicity In SCCS/1555/15, the SCCS derived a NOAEL of 25 mg/kg/d based on a re-analysis by Kwock and Silva (2013) of data from a teratology study performed in New Zealand White Rabbits (Zablotny et al., 1991b). This NOAEL is lower than other PoDs obtained from other repeat- dose/long-term toxicity studies performed with OPP and SOPP. Therefore, this conservative value of 25 mg/kg bw/d is taken for MoS calculation for both, OPP and SOPP. 3.4.6 Mutagenicity / genot; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"ncreased incidence of cleft palate, were observed even at the lowest dose tested (100 mg/kg bw/day).","duration":"developmental","effect":"SCCS-rejected applicant NOAEL: ncreased incidence of cleft palate, were observed even at the lowest dose tested (100 mg/kg bw/day). The only developmental toxicity study with SOPP, is not considered to be useful in safety assessment due to design and reporting limitations. However, it did suggest SOPP's potential interference with rodent development. In summary, while OPP did not adversely affect fertility or reproductive organs, the increased incidence of resorptions can be considered a developmental effect of both OPP and SOPP with a critical NOAEL of 25 mg/kg bw/day. SCCS comment on developmental toxicity In SCCS/1555/15, the SCCS derived a NOAEL of 25 mg/kg/d based on a re-analysis by Kwock and Silva (2013) of data from a teratology study performed in New Zealand White Rabbits (Zablotny et al., 1991b). This NOAEL is lower than other PoDs obtained from other repeat- dose/long-term toxicity studies performed with OPP and SOPP. Therefore, this conservative value of 25 mg/kg bw/d is taken for MoS calculation for both, OPP and SOPP. 3.4.6 Mutagenicity / genot","endpoint":"reproductive toxicity","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"25","page":31,"route":"","species":"rabbit","study_id":"sccs_o_291_noael_002"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies reproductive toxicity 25 mg/kg/d rabbit - developmental reproductive toxicity SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=25; DOSE=In summary, while OPP did not adversely affect fertility or reproductive organs, the increased incidence of resorptions can be considered a developmental effect of both OPP and SOPP with a critical NOAEL of 25 mg/kg bw/day.; EFFECT=SCCS-rejected applicant NOAEL: he only developmental toxicity study with SOPP, is not considered to be useful in safety assessment due to design and reporting limitations. However, it did suggest SOPP's potential interference with rodent development. In summary, while OPP did not adversely affect fertility or reproductive organs, the increased incidence of resorptions can be considered a developmental effect of both OPP and SOPP with a critical NOAEL of 25 mg/kg bw/day. SCCS comment on developmental toxicity In SCCS/1555/15, the SCCS derived a NOAEL of 25 mg/kg/d based on a re-analysis by Kwock and Silva (2013) of data from a teratology study performed in New Zealand White Rabbits (Zablotny et al., 1991b). This NOAEL is lower than other PoDs obtained from other repeat- dose/long-term toxicity studies performed with OPP and SOPP. Therefore, this conservative value of 25 mg/kg bw/d is taken for MoS calculation for both, OPP and SOPP. 3.4.6 Mutagenicity / genotoxicity According to the Applicant In in vitro assays with OPP and SOPP, minimal evidence of mutageni; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"In summary, while OPP did not adversely affect fertility or reproductive organs, the increased incidence of resorptions can be considered a developmental effect of both OPP and SOPP with a critical NOAEL of 25 mg/kg bw/day.","duration":"developmental","effect":"SCCS-rejected applicant NOAEL: he only developmental toxicity study with SOPP, is not considered to be useful in safety assessment due to design and reporting limitations. However, it did suggest SOPP's potential interference with rodent development. In summary, while OPP did not adversely affect fertility or reproductive organs, the increased incidence of resorptions can be considered a developmental effect of both OPP and SOPP with a critical NOAEL of 25 mg/kg bw/day. SCCS comment on developmental toxicity In SCCS/1555/15, the SCCS derived a NOAEL of 25 mg/kg/d based on a re-analysis by Kwock and Silva (2013) of data from a teratology study performed in New Zealand White Rabbits (Zablotny et al., 1991b). This NOAEL is lower than other PoDs obtained from other repeat- dose/long-term toxicity studies performed with OPP and SOPP. Therefore, this conservative value of 25 mg/kg bw/d is taken for MoS calculation for both, OPP and SOPP. 3.4.6 Mutagenicity / genotoxicity According to the Applicant In in vitro assays with OPP and SOPP, minimal evidence of mutageni","endpoint":"reproductive toxicity","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg/d","noael_value":"25","page":31,"route":"","species":"rabbit","study_id":"sccs_o_291_noael_003"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies reproductive toxicity 25 mg/kg/d rabbit oral developmental reproductive toxicity SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=25; DOSE=In summary, while OPP did not adversely affect fertility or reproductive organs, the increased incidence of resorptions can be considered a developmental effect of both OPP and SOPP with a critical NOAEL of 25 mg/kg bw/day.; EFFECT=potential interference with rodent development. In summary, while OPP did not adversely affect fertility or reproductive organs, the increased incidence of resorptions can be considered a developmental effect of both OPP and SOPP with a critical NOAEL of 25 mg/kg bw/day. SCCS comment on developmental toxicity In SCCS/1555/15, the SCCS derived a NOAEL of 25 mg/kg/d based on a re-analysis by Kwock and Silva (2013) of data from a teratology study performed in New Zealand White Rabbits (Zablotny et al., 1991b). This NOAEL is lower than other PoDs obtained from other repeat- dose/long-term toxicity studies performed with OPP and SOPP. Therefore, this conservative value of 25 mg/kg bw/d is taken for MoS calculation for both, OPP and SOPP. 3.4.6 Mutagenicity / genotoxicity According to the Applicant In in vitro assays with OPP and SOPP, minimal evidence of mutagenicity was observed, while clastogenicity occurred primarily in the presence of overt cytotoxicity. In vivo, micronucleus formation and/or DNA damage after oral or dermal ex; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"In summary, while OPP did not adversely affect fertility or reproductive organs, the increased incidence of resorptions can be considered a developmental effect of both OPP and SOPP with a critical NOAEL of 25 mg/kg bw/day.","duration":"developmental","effect":"potential interference with rodent development. In summary, while OPP did not adversely affect fertility or reproductive organs, the increased incidence of resorptions can be considered a developmental effect of both OPP and SOPP with a critical NOAEL of 25 mg/kg bw/day. SCCS comment on developmental toxicity In SCCS/1555/15, the SCCS derived a NOAEL of 25 mg/kg/d based on a re-analysis by Kwock and Silva (2013) of data from a teratology study performed in New Zealand White Rabbits (Zablotny et al., 1991b). This NOAEL is lower than other PoDs obtained from other repeat- dose/long-term toxicity studies performed with OPP and SOPP. Therefore, this conservative value of 25 mg/kg bw/d is taken for MoS calculation for both, OPP and SOPP. 3.4.6 Mutagenicity / genotoxicity According to the Applicant In in vitro assays with OPP and SOPP, minimal evidence of mutagenicity was observed, while clastogenicity occurred primarily in the presence of overt cytotoxicity. In vivo, micronucleus formation and/or DNA damage after oral or dermal ex","endpoint":"reproductive toxicity","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg/d","noael_value":"25","page":31,"route":"oral","species":"rabbit","study_id":"sccs_o_291_noael_004"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies reproductive toxicity 25 mg/kg bw/day rat - developmental reproductive toxicity SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=25; DOSE=NOAELs for systemic effects of 35 and 100 mg/kg bw/d were derived from the two studies based on morphologic findings in kidneys and urinary bladder.; EFFECT=udies have been performed with OPP in rats. There were no indications of an adverse effect on fertility of parental animals or on embryotoxicity or teratogenic effects in both studies. NOAELs for systemic effects of 35 and 100 mg/kg bw/d were derived from the two studies based on morphologic findings in kidneys and urinary bladder. While OPP did not adversely affect fertility or reproductive organs, the increased incidence of resorptions can be considered a developmental effect of both OPP and SOPP with a critical NOAEL of 25 mg/kg bw/day. Mutagenicity / genotoxicity Three new in vivo datasets have been analysed by the SCCS, i.e. one micronucleus test of limited reliability on OPP on bladder epithelial cells with positive result, one Comet assay of; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"NOAELs for systemic effects of 35 and 100 mg/kg bw/d were derived from the two studies based on morphologic findings in kidneys and urinary bladder.","duration":"developmental","effect":"udies have been performed with OPP in rats. There were no indications of an adverse effect on fertility of parental animals or on embryotoxicity or teratogenic effects in both studies. NOAELs for systemic effects of 35 and 100 mg/kg bw/d were derived from the two studies based on morphologic findings in kidneys and urinary bladder. While OPP did not adversely affect fertility or reproductive organs, the increased incidence of resorptions can be considered a developmental effect of both OPP and SOPP with a critical NOAEL of 25 mg/kg bw/day. Mutagenicity / genotoxicity Three new in vivo datasets have been analysed by the SCCS, i.e. one micronucleus test of limited reliability on OPP on bladder epithelial cells with positive result, one Comet assay of","endpoint":"reproductive toxicity","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"25","page":44,"route":"","species":"rat","study_id":"sccs_o_291_noael_022"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies reproductive toxicity 490 mg/kg bw/day rat oral - reproductive toxicity SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=490; DOSE=0, 40, 140 and 490 mg/kg bw/day Actual:; EFFECT=SCCS/1669/24 Final version Opinion on the safety of Biphenyl-2-ol and Sodium 2-biphenylolate (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 70 9.5 ANNEX 5. Reproductive and development toxicity Overview of reproductive toxicity studies Study type, Species Doses Critical effects NOAEL or LOAEL Reference#/ KL rating OPP Two- generation dietary reproductive toxicity study, CD Sprague- Dawley rats, (32-35/sex group) OECD TG 416 Nominal: 0, 40, 140 and 490 mg/kg bw/day Actual: 0, 35, 125 and 457 mg/kg bw/day for 2 generations Parental effects At 457 mg/kg bw/day, ↓ body weight, body weight gain and terminal body weight in males and females, ↑ relative weight of ovaries in females, ↑ Incidence of renal calculi and haemorrhage in males. ↑ Incidence of bladder calculi and urinary bladder transitional; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"0, 40, 140 and 490 mg/kg bw/day Actual:","duration":"","effect":"SCCS/1669/24 Final version Opinion on the safety of Biphenyl-2-ol and Sodium 2-biphenylolate (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 70 9.5 ANNEX 5. Reproductive and development toxicity Overview of reproductive toxicity studies Study type, Species Doses Critical effects NOAEL or LOAEL Reference#/ KL rating OPP Two- generation dietary reproductive toxicity study, CD Sprague- Dawley rats, (32-35/sex group) OECD TG 416 Nominal: 0, 40, 140 and 490 mg/kg bw/day Actual: 0, 35, 125 and 457 mg/kg bw/day for 2 generations Parental effects At 457 mg/kg bw/day, ↓ body weight, body weight gain and terminal body weight in males and females, ↑ relative weight of ovaries in females, ↑ Incidence of renal calculi and haemorrhage in males. ↑ Incidence of bladder calculi and urinary bladder transitional","endpoint":"reproductive toxicity","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"490","page":70,"route":"oral","species":"rat","study_id":"sccs_o_291_noael_042"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies reproductive toxicity 35 mg/kg bw/day - - - reproductive toxicity SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=35; DOSE=ght of testes and kidney in males, ↑ Incidence of urinary bladder transitional cell hyperplasia in males At 125 mg/kg bw/day Parental effects ↑ in body weight gain and changes in food consumptions, ↑ relative weight of ovaries in females, ↑ Incidence of average number cells/layer in females and ↑ Incidence of bladder calculi in males were observed.; EFFECT=ght of testes and kidney in males, ↑ Incidence of urinary bladder transitional cell hyperplasia in males At 125 mg/kg bw/day Parental effects ↑ in body weight gain and changes in food consumptions, ↑ relative weight of ovaries in females, ↑ Incidence of average number cells/layer in females and ↑ Incidence of bladder calculi in males were observed. F1 effects ↑ Absolute weight of liver and kidney and testes in males, ↓ incidence of average number of cells/layers of urinary bladder were observed. At 35 mg/kg bw/day NOAEL (systemic toxicity): 35 mg/kg bw/day NOAEL (reproductive toxicity): 457 mg/kg bw/day NOAEL (offspring toxicity): 125 mg/kg bw/day Eigenberg et al., 1990 in (ECHA RAC, 2022; ECHA, 2023b; SCCS, 2015)/KL2; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"ght of testes and kidney in males, ↑ Incidence of urinary bladder transitional cell hyperplasia in males At 125 mg/kg bw/day Parental effects ↑ in body weight gain and changes in food consumptions, ↑ relative weight of ovaries in females, ↑ Incidence of average number cells/layer in females and ↑ Incidence of bladder calculi in males were observed.","duration":"","effect":"ght of testes and kidney in males, ↑ Incidence of urinary bladder transitional cell hyperplasia in males At 125 mg/kg bw/day Parental effects ↑ in body weight gain and changes in food consumptions, ↑ relative weight of ovaries in females, ↑ Incidence of average number cells/layer in females and ↑ Incidence of bladder calculi in males were observed. F1 effects ↑ Absolute weight of liver and kidney and testes in males, ↓ incidence of average number of cells/layers of urinary bladder were observed. At 35 mg/kg bw/day NOAEL (systemic toxicity): 35 mg/kg bw/day NOAEL (reproductive toxicity): 457 mg/kg bw/day NOAEL (offspring toxicity): 125 mg/kg bw/day Eigenberg et al., 1990 in (ECHA RAC, 2022; ECHA, 2023b; SCCS, 2015)/KL2","endpoint":"reproductive toxicity","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"35","page":70,"route":"","species":"","study_id":"sccs_o_291_noael_043"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies reproductive toxicity 35 mg/kg bw/day - - - reproductive toxicity SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=35; DOSE=nce of urinary bladder transitional cell hyperplasia in males At 125 mg/kg bw/day Parental effects ↑ in body weight gain and changes in food consumptions, ↑ relative weight of ovaries in females, ↑ Incidence of average number cells/layer in females and ↑ Incidence of bladder calculi in males were observed.; EFFECT=nce of urinary bladder transitional cell hyperplasia in males At 125 mg/kg bw/day Parental effects ↑ in body weight gain and changes in food consumptions, ↑ relative weight of ovaries in females, ↑ Incidence of average number cells/layer in females and ↑ Incidence of bladder calculi in males were observed. F1 effects ↑ Absolute weight of liver and kidney and testes in males, ↓ incidence of average number of cells/layers of urinary bladder were observed. At 35 mg/kg bw/day NOAEL (systemic toxicity): 35 mg/kg bw/day NOAEL (reproductive toxicity): 457 mg/kg bw/day NOAEL (offspring toxicity): 125 mg/kg bw/day Eigenberg et al., 1990 in (ECHA RAC, 2022; ECHA, 2023b; SCCS, 2015)/KL2; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"nce of urinary bladder transitional cell hyperplasia in males At 125 mg/kg bw/day Parental effects ↑ in body weight gain and changes in food consumptions, ↑ relative weight of ovaries in females, ↑ Incidence of average number cells/layer in females and ↑ Incidence of bladder calculi in males were observed.","duration":"","effect":"nce of urinary bladder transitional cell hyperplasia in males At 125 mg/kg bw/day Parental effects ↑ in body weight gain and changes in food consumptions, ↑ relative weight of ovaries in females, ↑ Incidence of average number cells/layer in females and ↑ Incidence of bladder calculi in males were observed. F1 effects ↑ Absolute weight of liver and kidney and testes in males, ↓ incidence of average number of cells/layers of urinary bladder were observed. At 35 mg/kg bw/day NOAEL (systemic toxicity): 35 mg/kg bw/day NOAEL (reproductive toxicity): 457 mg/kg bw/day NOAEL (offspring toxicity): 125 mg/kg bw/day Eigenberg et al., 1990 in (ECHA RAC, 2022; ECHA, 2023b; SCCS, 2015)/KL2","endpoint":"reproductive toxicity","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"35","page":70,"route":"","species":"","study_id":"sccs_o_291_noael_044"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies reproductive toxicity 457 mg/kg bw/day - - - reproductive toxicity SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=457; DOSE=asia in males At 125 mg/kg bw/day Parental effects ↑ in body weight gain and changes in food consumptions, ↑ relative weight of ovaries in females, ↑ Incidence of average number cells/layer in females and ↑ Incidence of bladder calculi in males were observed.; EFFECT=asia in males At 125 mg/kg bw/day Parental effects ↑ in body weight gain and changes in food consumptions, ↑ relative weight of ovaries in females, ↑ Incidence of average number cells/layer in females and ↑ Incidence of bladder calculi in males were observed. F1 effects ↑ Absolute weight of liver and kidney and testes in males, ↓ incidence of average number of cells/layers of urinary bladder were observed. At 35 mg/kg bw/day NOAEL (systemic toxicity): 35 mg/kg bw/day NOAEL (reproductive toxicity): 457 mg/kg bw/day NOAEL (offspring toxicity): 125 mg/kg bw/day Eigenberg et al., 1990 in (ECHA RAC, 2022; ECHA, 2023b; SCCS, 2015)/KL2; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"asia in males At 125 mg/kg bw/day Parental effects ↑ in body weight gain and changes in food consumptions, ↑ relative weight of ovaries in females, ↑ Incidence of average number cells/layer in females and ↑ Incidence of bladder calculi in males were observed.","duration":"","effect":"asia in males At 125 mg/kg bw/day Parental effects ↑ in body weight gain and changes in food consumptions, ↑ relative weight of ovaries in females, ↑ Incidence of average number cells/layer in females and ↑ Incidence of bladder calculi in males were observed. F1 effects ↑ Absolute weight of liver and kidney and testes in males, ↓ incidence of average number of cells/layers of urinary bladder were observed. At 35 mg/kg bw/day NOAEL (systemic toxicity): 35 mg/kg bw/day NOAEL (reproductive toxicity): 457 mg/kg bw/day NOAEL (offspring toxicity): 125 mg/kg bw/day Eigenberg et al., 1990 in (ECHA RAC, 2022; ECHA, 2023b; SCCS, 2015)/KL2","endpoint":"reproductive toxicity","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"457","page":70,"route":"","species":"","study_id":"sccs_o_291_noael_045"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies reproductive toxicity 457 mg/kg bw/day - oral - reproductive toxicity SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=457; DOSE=F1 effects -↓ body weight, feed consumption and absolute weight of kidney and testes in males Reproductive parameters P and F1 At 457 mg/kg bw/day, ↑ female fertility index during F1b generation At 125 mg/kg bw/day, ↑ female fertility index during F1b generation At 35 mg/kg bw/day, ↑ female fertility index during F1b generation However, this inc...; EFFECT=SCCS/1669/24 Final version Opinion on the safety of Biphenyl-2-ol and Sodium 2-biphenylolate (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 71 Study type, Species Doses Critical effects NOAEL or LOAEL Reference#/ KL rating Parental effects There were no treatment- related effects. F1 effects -↓ body weight, feed consumption and absolute weight of kidney and testes in males Reproductive parameters P and F1 At 457 mg/kg bw/day, ↑ female fertility index during F1b generation At 125 mg/kg bw/day, ↑ female fertility index during F1b generation At 35 mg/kg bw/day, ↑ female fertility index during F1b generation However, this increase in the fertility index is considered an artifact due to the extremely low fe; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"F1 effects -↓ body weight, feed consumption and absolute weight of kidney and testes in males Reproductive parameters P and F1 At 457 mg/kg bw/day, ↑ female fertility index during F1b generation At 125 mg/kg bw/day, ↑ female fertility index during F1b generation At 35 mg/kg bw/day, ↑ female fertility index during F1b generation However, this inc...","duration":"","effect":"SCCS/1669/24 Final version Opinion on the safety of Biphenyl-2-ol and Sodium 2-biphenylolate (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 71 Study type, Species Doses Critical effects NOAEL or LOAEL Reference#/ KL rating Parental effects There were no treatment- related effects. F1 effects -↓ body weight, feed consumption and absolute weight of kidney and testes in males Reproductive parameters P and F1 At 457 mg/kg bw/day, ↑ female fertility index during F1b generation At 125 mg/kg bw/day, ↑ female fertility index during F1b generation At 35 mg/kg bw/day, ↑ female fertility index during F1b generation However, this increase in the fertility index is considered an artifact due to the extremely low fe","endpoint":"reproductive toxicity","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"457","page":71,"route":"oral","species":"","study_id":"sccs_o_291_noael_046"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies reproductive toxicity 92 mg/kg bw/day rat - chronic reproductive toxicity SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=92; DOSE=0, 20, 100 and 500 mg/kg bw/day Actual:; EFFECT=wley rats, (30/sex/group ) OECD TG 416 Nominal: 0, 20, 100 and 500 mg/kg bw/day Actual: 18/17, 93/92 and 459/457 mg/kg bw/day for males and females, respectively Parental effects At 459/457 mg/kg bw/day, no treatment-related increase in mortality, changes in body weight and terminal body weight, ↓ food consumption in males and females, ↑ incidence of histopathological alterations in males: in the urinary bladder; chronic Inflammation, nodular/papillary; simple hyperplasia, and the ureter dilatation and hyperplasia NOAEL (systemic and offspring toxicity): 92 mg/kg bw/day NOAEL (reproductive toxicity): 457 mg/kg bw/day Eigenberg and Lake 1995 in (ECHA RAC, 2022; ECHA, 2023b; SCCS, 2015)/KL1; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"0, 20, 100 and 500 mg/kg bw/day Actual:","duration":"chronic","effect":"wley rats, (30/sex/group ) OECD TG 416 Nominal: 0, 20, 100 and 500 mg/kg bw/day Actual: 18/17, 93/92 and 459/457 mg/kg bw/day for males and females, respectively Parental effects At 459/457 mg/kg bw/day, no treatment-related increase in mortality, changes in body weight and terminal body weight, ↓ food consumption in males and females, ↑ incidence of histopathological alterations in males: in the urinary bladder; chronic Inflammation, nodular/papillary; simple hyperplasia, and the ureter dilatation and hyperplasia NOAEL (systemic and offspring toxicity): 92 mg/kg bw/day NOAEL (reproductive toxicity): 457 mg/kg bw/day Eigenberg and Lake 1995 in (ECHA RAC, 2022; ECHA, 2023b; SCCS, 2015)/KL1","endpoint":"reproductive toxicity","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"92","page":71,"route":"","species":"rat","study_id":"sccs_o_291_noael_047"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies reproductive toxicity 92 mg/kg bw/day - - chronic reproductive toxicity SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=92; DOSE=0 and 500 mg/kg bw/day Actual:; EFFECT=0 and 500 mg/kg bw/day Actual: 18/17, 93/92 and 459/457 mg/kg bw/day for males and females, respectively Parental effects At 459/457 mg/kg bw/day, no treatment-related increase in mortality, changes in body weight and terminal body weight, ↓ food consumption in males and females, ↑ incidence of histopathological alterations in males: in the urinary bladder; chronic Inflammation, nodular/papillary; simple hyperplasia, and the ureter dilatation and hyperplasia NOAEL (systemic and offspring toxicity): 92 mg/kg bw/day NOAEL (reproductive toxicity): 457 mg/kg bw/day Eigenberg and Lake 1995 in (ECHA RAC, 2022; ECHA, 2023b; SCCS, 2015)/KL1; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"0 and 500 mg/kg bw/day Actual:","duration":"chronic","effect":"0 and 500 mg/kg bw/day Actual: 18/17, 93/92 and 459/457 mg/kg bw/day for males and females, respectively Parental effects At 459/457 mg/kg bw/day, no treatment-related increase in mortality, changes in body weight and terminal body weight, ↓ food consumption in males and females, ↑ incidence of histopathological alterations in males: in the urinary bladder; chronic Inflammation, nodular/papillary; simple hyperplasia, and the ureter dilatation and hyperplasia NOAEL (systemic and offspring toxicity): 92 mg/kg bw/day NOAEL (reproductive toxicity): 457 mg/kg bw/day Eigenberg and Lake 1995 in (ECHA RAC, 2022; ECHA, 2023b; SCCS, 2015)/KL1","endpoint":"reproductive toxicity","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"92","page":71,"route":"","species":"","study_id":"sccs_o_291_noael_048"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies reproductive toxicity 92 mg/kg bw/day - - chronic reproductive toxicity SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=92; DOSE=At 93/92 mg/kg bw/day, no statistically significant treatment related effects were observed in Parents and F1 Reproductive parameters At 459/457 mg/kg bw/day, Parent; EFFECT=SCCS/1669/24 Final version Opinion on the safety of Biphenyl-2-ol and Sodium 2-biphenylolate (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 72 Study type, Species Doses Critical effects NOAEL or LOAEL Reference#/ KL rating were observed. F1 effects - changes in body weight and terminal body weight, ↑ food consumption in males and females, ↑ relative weight of testes, ↑ incidence of histopathological alterations in males in the urinary bladder, chronic inflammation; nodular/papillary and simple hyperplasia, and kidney debris were observed. At 93/92 mg/kg bw/day, no statistically significant treatment related effects were observed in Parents and F1 Reproductive parameters At 459/457 mg/kg bw/day, Parent; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"At 93/92 mg/kg bw/day, no statistically significant treatment related effects were observed in Parents and F1 Reproductive parameters At 459/457 mg/kg bw/day, Parent","duration":"chronic","effect":"SCCS/1669/24 Final version Opinion on the safety of Biphenyl-2-ol and Sodium 2-biphenylolate (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 72 Study type, Species Doses Critical effects NOAEL or LOAEL Reference#/ KL rating were observed. F1 effects - changes in body weight and terminal body weight, ↑ food consumption in males and females, ↑ relative weight of testes, ↑ incidence of histopathological alterations in males in the urinary bladder, chronic inflammation; nodular/papillary and simple hyperplasia, and kidney debris were observed. At 93/92 mg/kg bw/day, no statistically significant treatment related effects were observed in Parents and F1 Reproductive parameters At 459/457 mg/kg bw/day, Parent","endpoint":"reproductive toxicity","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"92","page":72,"route":"","species":"","study_id":"sccs_o_291_noael_049"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies reproductive toxicity 2100 mg/kg bw/day mouse oral Developmental reproductive toxicity SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=2100; DOSE=At 93/92 mg/kg bw/day, no statistically significant treatment related effects were observed in Parents and F1 Reproductive parameters At 459/457 mg/kg bw/day, Parents, F1 and F2 - ↑ fertility index during F2b generation, ↑ food consumption during gestation was observed However, this increase in the fertility index is considered an artifact due t...; LOAEL_VALUE=1450 mg/kg bw/day; EFFECT=ia, and kidney debris were observed. At 93/92 mg/kg bw/day, no statistically significant treatment related effects were observed in Parents and F1 Reproductive parameters At 459/457 mg/kg bw/day, Parents, F1 and F2 - ↑ fertility index during F2b generation, ↑ food consumption during gestation was observed However, this increase in the fertility index is considered an artifact due to the extremely low fertility index for the control group. Developmental toxicity studies Study type, Species Doses Critical effects NOAEL or LOAEL Reference#/ KL rating OPP Prenatal developmental toxicity via gavage in JCL- ICR mice, (21 females/group), similar to OCED TG 414 0, 1450, 1740 and 2100 mg/kg bw/day, GD 7-15 Maternal toxicity At 2100 mg/kg bw/day, ↑ mortality: 5 mice died on GD 8, 7 on GD 9 and 2 each on GD 11 and 12, ↓ body weight/body weight gain and ↓ in absolute/relative heart weight were observed. At 1740 mg/kg bw/day, ↑ LOAEL (maternal and developmental toxicity): 1450 mg/kg bw/day Ogata et al., 1978 in (EC, 2023; ECHA, 2023b; ECHA; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"At 93/92 mg/kg bw/day, no statistically significant treatment related effects were observed in Parents and F1 Reproductive parameters At 459/457 mg/kg bw/day, Parents, F1 and F2 - ↑ fertility index during F2b generation, ↑ food consumption during gestation was observed However, this increase in the fertility index is considered an artifact due t...","duration":"Developmental","effect":"ia, and kidney debris were observed. At 93/92 mg/kg bw/day, no statistically significant treatment related effects were observed in Parents and F1 Reproductive parameters At 459/457 mg/kg bw/day, Parents, F1 and F2 - ↑ fertility index during F2b generation, ↑ food consumption during gestation was observed However, this increase in the fertility index is considered an artifact due to the extremely low fertility index for the control group. Developmental toxicity studies Study type, Species Doses Critical effects NOAEL or LOAEL Reference#/ KL rating OPP Prenatal developmental toxicity via gavage in JCL- ICR mice, (21 females/group), similar to OCED TG 414 0, 1450, 1740 and 2100 mg/kg bw/day, GD 7-15 Maternal toxicity At 2100 mg/kg bw/day, ↑ mortality: 5 mice died on GD 8, 7 on GD 9 and 2 each on GD 11 and 12, ↓ body weight/body weight gain and ↓ in absolute/relative heart weight were observed. At 1740 mg/kg bw/day, ↑ LOAEL (maternal and developmental toxicity): 1450 mg/kg bw/day Ogata et al., 1978 in (EC, 2023; ECHA, 2023b; ECHA","endpoint":"reproductive toxicity","ingredient":"s, toys, textiles, clothing,","loael_value":"1450 mg/kg bw/day","noael_unit":"mg/kg bw/day","noael_value":"2100","page":72,"route":"oral","species":"mouse","study_id":"sccs_o_291_noael_050"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies reproductive toxicity 1450 mg/kg bw/day mouse - - reproductive toxicity SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=1450; DOSE=At 1450 mg/kg bw/day, ↑ mortality:; EFFECT=SCCS/1669/24 Final version Opinion on the safety of Biphenyl-2-ol and Sodium 2-biphenylolate (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 73 Study type, Species Doses Critical effects NOAEL or LOAEL Reference#/ KL rating mortality: 4 mice died on GD 7 and 1 each on GD 14, GD 15, and GD 16, ↓ body weight/body weight gain (no numerical data available), ↓ in absolute/relative heart weight and ↑ in relative liver weight. At 1450 mg/kg bw/day, ↑ mortality: 1 mouse died each on GD 11 and 15, 2 mice died on GD 16. ↑ in absolute/relative liver weight. Litter/reproductive data At 2100 mg/kg bw/day, ↓ foetal bodyweight, ↑ frequency of foetuses with cervical ribs, ↓ mean number of ossified left/right phalanges; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"At 1450 mg/kg bw/day, ↑ mortality:","duration":"","effect":"SCCS/1669/24 Final version Opinion on the safety of Biphenyl-2-ol and Sodium 2-biphenylolate (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 73 Study type, Species Doses Critical effects NOAEL or LOAEL Reference#/ KL rating mortality: 4 mice died on GD 7 and 1 each on GD 14, GD 15, and GD 16, ↓ body weight/body weight gain (no numerical data available), ↓ in absolute/relative heart weight and ↑ in relative liver weight. At 1450 mg/kg bw/day, ↑ mortality: 1 mouse died each on GD 11 and 15, 2 mice died on GD 16. ↑ in absolute/relative liver weight. Litter/reproductive data At 2100 mg/kg bw/day, ↓ foetal bodyweight, ↑ frequency of foetuses with cervical ribs, ↓ mean number of ossified left/right phalanges","endpoint":"reproductive toxicity","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"1450","page":73,"route":"","species":"mouse","study_id":"sccs_o_291_noael_051"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies reproductive toxicity 500 mg/kg bw/day - - - reproductive toxicity SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=500; DOSE=500 mg/kg bw/day, ↓ body weight gain, ↑ kidney absolute/relative weight, gross pathology:; EFFECT=SCCS/1669/24 Final version Opinion on the safety of Biphenyl-2-ol and Sodium 2-biphenylolate (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 75 Study type, Species Doses Critical effects NOAEL or LOAEL Reference#/ KL rating body weight gain, clinical signs such as decreased amount of faeces, blood in pan and abnormal respiration were observed. - Gross pathology: Digestive tract haemorrhage, gaseous distension and erosions of the stomach, decreased/soft ingest of the gastrointestinal tract, haemolysed blood in intestines, pale kidneys. 500 mg/kg bw/day, ↓ body weight gain, ↑ kidney absolute/relative weight, gross pathology: Pale kidneys 250 mg/kg bw/day, ↑ kidney relative weight Reproductive parameters N; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"500 mg/kg bw/day, ↓ body weight gain, ↑ kidney absolute/relative weight, gross pathology:","duration":"","effect":"SCCS/1669/24 Final version Opinion on the safety of Biphenyl-2-ol and Sodium 2-biphenylolate (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products ___________________________________________________________________________________________ _________________________________________________________________________________________ 75 Study type, Species Doses Critical effects NOAEL or LOAEL Reference#/ KL rating body weight gain, clinical signs such as decreased amount of faeces, blood in pan and abnormal respiration were observed. - Gross pathology: Digestive tract haemorrhage, gaseous distension and erosions of the stomach, decreased/soft ingest of the gastrointestinal tract, haemolysed blood in intestines, pale kidneys. 500 mg/kg bw/day, ↓ body weight gain, ↑ kidney absolute/relative weight, gross pathology: Pale kidneys 250 mg/kg bw/day, ↑ kidney relative weight Reproductive parameters N","endpoint":"reproductive toxicity","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"500","page":75,"route":"","species":"","study_id":"sccs_o_291_noael_058"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies reproductive toxicity 100 mg/kg bw/day - - developmental reproductive toxicity SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=100; DOSE=Reproductive and litter parameters At 250 mg/kg bw/day, ↑ % litters with resorptions, ↑ number of resorptions/ litters, ↑ post implantation loss, At 100 mg/kg bw/day, ↑ % litters with resorptions, ↑ number of resorptions/ litters, ↑ post implantation loss.; EFFECT=ling and blood in pan were observed. Treatment-related effects on the kidneys, ulceration, and haemorrhage of the gastric mucosa, haemolysed blood within intestinal tract and ↓ content and ↑ fluidity of ingesta, histopathological changes of kidney were observed. Reproductive and litter parameters At 250 mg/kg bw/day, ↑ % litters with resorptions, ↑ number of resorptions/ litters, ↑ post implantation loss, At 100 mg/kg bw/day, ↑ % litters with resorptions, ↑ number of resorptions/ litters, ↑ post implantation loss. NOAEL (maternal): 100 mg/kg bw/day NOAEL (developmental): 25 mg mg/kg bw/dayj Zablotny et al.,1991, in (Cal EPA, 2007; EC, 2023; ECHA, 2023b; ECHA RAC, 2022; EU CAR, 2015; Health Canada, 2020; SCCS, 2015; US EPA, 2006)/KL1; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"Reproductive and litter parameters At 250 mg/kg bw/day, ↑ % litters with resorptions, ↑ number of resorptions/ litters, ↑ post implantation loss, At 100 mg/kg bw/day, ↑ % litters with resorptions, ↑ number of resorptions/ litters, ↑ post implantation loss.","duration":"developmental","effect":"ling and blood in pan were observed. Treatment-related effects on the kidneys, ulceration, and haemorrhage of the gastric mucosa, haemolysed blood within intestinal tract and ↓ content and ↑ fluidity of ingesta, histopathological changes of kidney were observed. Reproductive and litter parameters At 250 mg/kg bw/day, ↑ % litters with resorptions, ↑ number of resorptions/ litters, ↑ post implantation loss, At 100 mg/kg bw/day, ↑ % litters with resorptions, ↑ number of resorptions/ litters, ↑ post implantation loss. NOAEL (maternal): 100 mg/kg bw/day NOAEL (developmental): 25 mg mg/kg bw/dayj Zablotny et al.,1991, in (Cal EPA, 2007; EC, 2023; ECHA, 2023b; ECHA RAC, 2022; EU CAR, 2015; Health Canada, 2020; SCCS, 2015; US EPA, 2006)/KL1","endpoint":"reproductive toxicity","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"100","page":75,"route":"","species":"","study_id":"sccs_o_291_noael_059"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies reproductive toxicity 100 mg/kg bw/day - - developmental reproductive toxicity SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=100; DOSE=Reproductive and litter parameters At 250 mg/kg bw/day, ↑ % litters with resorptions, ↑ number of resorptions/ litters, ↑ post implantation loss, At 100 mg/kg bw/day, ↑ % litters with resorptions, ↑ number of resorptions/ litters, ↑ post implantation loss.; EFFECT=. Treatment-related effects on the kidneys, ulceration, and haemorrhage of the gastric mucosa, haemolysed blood within intestinal tract and ↓ content and ↑ fluidity of ingesta, histopathological changes of kidney were observed. Reproductive and litter parameters At 250 mg/kg bw/day, ↑ % litters with resorptions, ↑ number of resorptions/ litters, ↑ post implantation loss, At 100 mg/kg bw/day, ↑ % litters with resorptions, ↑ number of resorptions/ litters, ↑ post implantation loss. NOAEL (maternal): 100 mg/kg bw/day NOAEL (developmental): 25 mg mg/kg bw/dayj Zablotny et al.,1991, in (Cal EPA, 2007; EC, 2023; ECHA, 2023b; ECHA RAC, 2022; EU CAR, 2015; Health Canada, 2020; SCCS, 2015; US EPA, 2006)/KL1; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"Reproductive and litter parameters At 250 mg/kg bw/day, ↑ % litters with resorptions, ↑ number of resorptions/ litters, ↑ post implantation loss, At 100 mg/kg bw/day, ↑ % litters with resorptions, ↑ number of resorptions/ litters, ↑ post implantation loss.","duration":"developmental","effect":". Treatment-related effects on the kidneys, ulceration, and haemorrhage of the gastric mucosa, haemolysed blood within intestinal tract and ↓ content and ↑ fluidity of ingesta, histopathological changes of kidney were observed. Reproductive and litter parameters At 250 mg/kg bw/day, ↑ % litters with resorptions, ↑ number of resorptions/ litters, ↑ post implantation loss, At 100 mg/kg bw/day, ↑ % litters with resorptions, ↑ number of resorptions/ litters, ↑ post implantation loss. NOAEL (maternal): 100 mg/kg bw/day NOAEL (developmental): 25 mg mg/kg bw/dayj Zablotny et al.,1991, in (Cal EPA, 2007; EC, 2023; ECHA, 2023b; ECHA RAC, 2022; EU CAR, 2015; Health Canada, 2020; SCCS, 2015; US EPA, 2006)/KL1","endpoint":"reproductive toxicity","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"100","page":75,"route":"","species":"","study_id":"sccs_o_291_noael_060"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies reproductive toxicity 490 mg/kg bw/day rat oral - reproductive toxicity SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=490; DOSE=0, 40, 140 and 490 mg/kg bw/day Actual:; EFFECT=Unlabeled table on page 70: Two- generation dietary reproductive toxicity study, CD Sprague- Dawley rats, (32-35/sex group) OECD TG 416 | Nominal: 0, 40, 140 and 490 mg/kg bw/day Actual: 0, 35, 125 and 457 mg/kg bw/day for 2 generations | Parental effects At 457 mg/kg bw/day, ↓ body weight, body weight gain and terminal body weight in males and females, ↑ relative weight of ovaries in females, ↑ Incidence of renal calculi and haemorrhage in males. ↑ Incidence of bladder calculi and urinary bladder transitional cell hyperplasia in males were observed. F1 effects -↓ body weight, body weight gain and terminal body weight in males and females, ↓ Absolute weight of liver and kidney in females, ↑ relative weight of testes and kidney in males, ↑ Incidence of urinary bladder transitional cell hyperplasia in males At 125 mg/kg bw/day Parental effects ↑ in body weight gain and changes in food consumptions, ↑ relative weight of ovaries in females, ↑ Incidence of average number cells/layer in females and ↑ Incidence of bladder calculi in males were observed. F1 effects ↑ Absolute weight of li...; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"0, 40, 140 and 490 mg/kg bw/day Actual:","duration":"","effect":"Unlabeled table on page 70: Two- generation dietary reproductive toxicity study, CD Sprague- Dawley rats, (32-35/sex group) OECD TG 416 | Nominal: 0, 40, 140 and 490 mg/kg bw/day Actual: 0, 35, 125 and 457 mg/kg bw/day for 2 generations | Parental effects At 457 mg/kg bw/day, ↓ body weight, body weight gain and terminal body weight in males and females, ↑ relative weight of ovaries in females, ↑ Incidence of renal calculi and haemorrhage in males. ↑ Incidence of bladder calculi and urinary bladder transitional cell hyperplasia in males were observed. F1 effects -↓ body weight, body weight gain and terminal body weight in males and females, ↓ Absolute weight of liver and kidney in females, ↑ relative weight of testes and kidney in males, ↑ Incidence of urinary bladder transitional cell hyperplasia in males At 125 mg/kg bw/day Parental effects ↑ in body weight gain and changes in food consumptions, ↑ relative weight of ovaries in females, ↑ Incidence of average number cells/layer in females and ↑ Incidence of bladder calculi in males were observed. F1 effects ↑ Absolute weight of li...","endpoint":"reproductive toxicity","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"490","page":70,"route":"oral","species":"rat","study_id":"sccs_o_291_noael_116"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies reproductive toxicity 35 mg/kg bw/day rat oral - reproductive toxicity SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=35; DOSE=0, 40, 140 and 490 mg/kg bw/day Actual:; EFFECT=Unlabeled table on page 70: Two- generation dietary reproductive toxicity study, CD Sprague- Dawley rats, (32-35/sex group) OECD TG 416 | Nominal: 0, 40, 140 and 490 mg/kg bw/day Actual: 0, 35, 125 and 457 mg/kg bw/day for 2 generations | Parental effects At 457 mg/kg bw/day, ↓ body weight, body weight gain and terminal body weight in males and females, ↑ relative weight of ovaries in females, ↑ Incidence of renal calculi and haemorrhage in males. ↑ Incidence of bladder calculi and urinary bladder transitional cell hyperplasia in males were observed. F1 effects -↓ body weight, body weight gain and terminal body weight in males and females, ↓ Absolute weight of liver and kidney in females, ↑ relative weight of testes and kidney in males, ↑ Incidence of urinary bladder transitional cell hyperplasia in males At 125 mg/kg bw/day Parental effects ↑ in body weight gain and changes in food consumptions, ↑ relative weight of ovaries in females, ↑ Incidence of average number cells/layer in females and ↑ Incidence of bladder calculi in males were observed. F1 effects ↑ Absolute weight of li...; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"0, 40, 140 and 490 mg/kg bw/day Actual:","duration":"","effect":"Unlabeled table on page 70: Two- generation dietary reproductive toxicity study, CD Sprague- Dawley rats, (32-35/sex group) OECD TG 416 | Nominal: 0, 40, 140 and 490 mg/kg bw/day Actual: 0, 35, 125 and 457 mg/kg bw/day for 2 generations | Parental effects At 457 mg/kg bw/day, ↓ body weight, body weight gain and terminal body weight in males and females, ↑ relative weight of ovaries in females, ↑ Incidence of renal calculi and haemorrhage in males. ↑ Incidence of bladder calculi and urinary bladder transitional cell hyperplasia in males were observed. F1 effects -↓ body weight, body weight gain and terminal body weight in males and females, ↓ Absolute weight of liver and kidney in females, ↑ relative weight of testes and kidney in males, ↑ Incidence of urinary bladder transitional cell hyperplasia in males At 125 mg/kg bw/day Parental effects ↑ in body weight gain and changes in food consumptions, ↑ relative weight of ovaries in females, ↑ Incidence of average number cells/layer in females and ↑ Incidence of bladder calculi in males were observed. F1 effects ↑ Absolute weight of li...","endpoint":"reproductive toxicity","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"35","page":70,"route":"oral","species":"rat","study_id":"sccs_o_291_noael_117"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies reproductive toxicity 500 mg/kg bw/day rat oral chronic reproductive toxicity SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=500; DOSE=0, 20, 100 and 500 mg/kg bw/day Actual:; EFFECT=Unlabeled table on page 71: Two- generation dietary reproductive toxicity study, CD Sprague- Dawley rats, (30/sex/group ) OECD TG 416 | Nominal: 0, 20, 100 and 500 mg/kg bw/day Actual: 18/17, 93/92 and 459/457 mg/kg bw/day for males and females, respectively | Parental effects At 459/457 mg/kg bw/day, no treatment-related increase in mortality, changes in body weight and terminal body weight, ↓ food consumption in males and females, ↑ incidence of histopathological alterations in males: in the urinary bladder; chronic Inflammation, nodular/papillary; simple hyperplasia, and the ureter dilatation and hyperplasia | NOAEL (systemic and offspring toxicity): 92 mg/kg bw/day NOAEL (reproductive toxicity): 457 mg/kg bw/day | Eigenberg and Lake 1995 in (ECHA RAC, 2022; ECHA, 2023b; SCCS, 2015)/KL1; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"0, 20, 100 and 500 mg/kg bw/day Actual:","duration":"chronic","effect":"Unlabeled table on page 71: Two- generation dietary reproductive toxicity study, CD Sprague- Dawley rats, (30/sex/group ) OECD TG 416 | Nominal: 0, 20, 100 and 500 mg/kg bw/day Actual: 18/17, 93/92 and 459/457 mg/kg bw/day for males and females, respectively | Parental effects At 459/457 mg/kg bw/day, no treatment-related increase in mortality, changes in body weight and terminal body weight, ↓ food consumption in males and females, ↑ incidence of histopathological alterations in males: in the urinary bladder; chronic Inflammation, nodular/papillary; simple hyperplasia, and the ureter dilatation and hyperplasia | NOAEL (systemic and offspring toxicity): 92 mg/kg bw/day NOAEL (reproductive toxicity): 457 mg/kg bw/day | Eigenberg and Lake 1995 in (ECHA RAC, 2022; ECHA, 2023b; SCCS, 2015)/KL1","endpoint":"reproductive toxicity","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"500","page":71,"route":"oral","species":"rat","study_id":"sccs_o_291_noael_119"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies reproductive toxicity 92 mg/kg bw/day rat oral chronic reproductive toxicity SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=92; DOSE=0, 20, 100 and 500 mg/kg bw/day Actual:; EFFECT=Unlabeled table on page 71: Two- generation dietary reproductive toxicity study, CD Sprague- Dawley rats, (30/sex/group ) OECD TG 416 | Nominal: 0, 20, 100 and 500 mg/kg bw/day Actual: 18/17, 93/92 and 459/457 mg/kg bw/day for males and females, respectively | Parental effects At 459/457 mg/kg bw/day, no treatment-related increase in mortality, changes in body weight and terminal body weight, ↓ food consumption in males and females, ↑ incidence of histopathological alterations in males: in the urinary bladder; chronic Inflammation, nodular/papillary; simple hyperplasia, and the ureter dilatation and hyperplasia | NOAEL (systemic and offspring toxicity): 92 mg/kg bw/day NOAEL (reproductive toxicity): 457 mg/kg bw/day | Eigenberg and Lake 1995 in (ECHA RAC, 2022; ECHA, 2023b; SCCS, 2015)/KL1; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"0, 20, 100 and 500 mg/kg bw/day Actual:","duration":"chronic","effect":"Unlabeled table on page 71: Two- generation dietary reproductive toxicity study, CD Sprague- Dawley rats, (30/sex/group ) OECD TG 416 | Nominal: 0, 20, 100 and 500 mg/kg bw/day Actual: 18/17, 93/92 and 459/457 mg/kg bw/day for males and females, respectively | Parental effects At 459/457 mg/kg bw/day, no treatment-related increase in mortality, changes in body weight and terminal body weight, ↓ food consumption in males and females, ↑ incidence of histopathological alterations in males: in the urinary bladder; chronic Inflammation, nodular/papillary; simple hyperplasia, and the ureter dilatation and hyperplasia | NOAEL (systemic and offspring toxicity): 92 mg/kg bw/day NOAEL (reproductive toxicity): 457 mg/kg bw/day | Eigenberg and Lake 1995 in (ECHA RAC, 2022; ECHA, 2023b; SCCS, 2015)/KL1","endpoint":"reproductive toxicity","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"92","page":71,"route":"oral","species":"rat","study_id":"sccs_o_291_noael_120"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies reproductive toxicity 250 mg/kg bw/day rabbit oral Prenatal reproductive toxicity SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=250; DOSE=Prenatal developmental toxicity via gavage in New Zealand White rabbits, (16-24 females/group), OECD TG 414 | 0, 25, 100 and 250 mg/kg bw/day, GD 7-19 | Maternal toxicity At 250 mg/kg bw/day, 5 females died due to treatment-related effects within the gastrointestinal tract, clinical signs such as decreased amount of faeces, perineal soiling and...; EFFECT=Unlabeled table on page 75: Prenatal developmental toxicity via gavage in New Zealand White rabbits, (16-24 females/group), OECD TG 414 | 0, 25, 100 and 250 mg/kg bw/day, GD 7-19 | Maternal toxicity At 250 mg/kg bw/day, 5 females died due to treatment-related effects within the gastrointestinal tract, clinical signs such as decreased amount of faeces, perineal soiling and blood in pan were observed. Treatment-related effects on the kidneys, ulceration, and haemorrhage of the gastric mucosa, haemolysed blood within intestinal tract and ↓ content and ↑ fluidity of ingesta, histopathological changes of kidney were observed. Reproductive and litter parameters At 250 mg/kg bw/day, ↑ % litters with resorptions, ↑ number of resorptions/ litters, ↑ post implantation loss, At 100 mg/kg bw/day, ↑ % litters with resorptions, ↑ number of resorptions/ litters, ↑ post implantation loss. | NOAEL (maternal): 100 mg/kg bw/day NOAEL (developmental): 25 mg mg/kg bw/dayj | Zablotny et al.,1991, in (Cal EPA, 2007; EC, 2023; ECHA, 2023b; ECHA RAC, 2022; EU CAR, 2015; Health Canada, 2020; SCCS, 2015; US...; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"Prenatal developmental toxicity via gavage in New Zealand White rabbits, (16-24 females/group), OECD TG 414 | 0, 25, 100 and 250 mg/kg bw/day, GD 7-19 | Maternal toxicity At 250 mg/kg bw/day, 5 females died due to treatment-related effects within the gastrointestinal tract, clinical signs such as decreased amount of faeces, perineal soiling and...","duration":"Prenatal","effect":"Unlabeled table on page 75: Prenatal developmental toxicity via gavage in New Zealand White rabbits, (16-24 females/group), OECD TG 414 | 0, 25, 100 and 250 mg/kg bw/day, GD 7-19 | Maternal toxicity At 250 mg/kg bw/day, 5 females died due to treatment-related effects within the gastrointestinal tract, clinical signs such as decreased amount of faeces, perineal soiling and blood in pan were observed. Treatment-related effects on the kidneys, ulceration, and haemorrhage of the gastric mucosa, haemolysed blood within intestinal tract and ↓ content and ↑ fluidity of ingesta, histopathological changes of kidney were observed. Reproductive and litter parameters At 250 mg/kg bw/day, ↑ % litters with resorptions, ↑ number of resorptions/ litters, ↑ post implantation loss, At 100 mg/kg bw/day, ↑ % litters with resorptions, ↑ number of resorptions/ litters, ↑ post implantation loss. | NOAEL (maternal): 100 mg/kg bw/day NOAEL (developmental): 25 mg mg/kg bw/dayj | Zablotny et al.,1991, in (Cal EPA, 2007; EC, 2023; ECHA, 2023b; ECHA RAC, 2022; EU CAR, 2015; Health Canada, 2020; SCCS, 2015; US...","endpoint":"reproductive toxicity","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"250","page":75,"route":"oral","species":"rabbit","study_id":"sccs_o_291_noael_132"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies reproductive toxicity 100 mg/kg bw/day rabbit oral Prenatal reproductive toxicity SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=100; DOSE=Prenatal developmental toxicity via gavage in New Zealand White rabbits, (16-24 females/group), OECD TG 414 | 0, 25, 100 and 250 mg/kg bw/day, GD 7-19 | Maternal toxicity At 250 mg/kg bw/day, 5 females died due to treatment-related effects within the gastrointestinal tract, clinical signs such as decreased amount of faeces, perineal soiling and...; EFFECT=Unlabeled table on page 75: Prenatal developmental toxicity via gavage in New Zealand White rabbits, (16-24 females/group), OECD TG 414 | 0, 25, 100 and 250 mg/kg bw/day, GD 7-19 | Maternal toxicity At 250 mg/kg bw/day, 5 females died due to treatment-related effects within the gastrointestinal tract, clinical signs such as decreased amount of faeces, perineal soiling and blood in pan were observed. Treatment-related effects on the kidneys, ulceration, and haemorrhage of the gastric mucosa, haemolysed blood within intestinal tract and ↓ content and ↑ fluidity of ingesta, histopathological changes of kidney were observed. Reproductive and litter parameters At 250 mg/kg bw/day, ↑ % litters with resorptions, ↑ number of resorptions/ litters, ↑ post implantation loss, At 100 mg/kg bw/day, ↑ % litters with resorptions, ↑ number of resorptions/ litters, ↑ post implantation loss. | NOAEL (maternal): 100 mg/kg bw/day NOAEL (developmental): 25 mg mg/kg bw/dayj | Zablotny et al.,1991, in (Cal EPA, 2007; EC, 2023; ECHA, 2023b; ECHA RAC, 2022; EU CAR, 2015; Health Canada, 2020; SCCS, 2015; US...; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"Prenatal developmental toxicity via gavage in New Zealand White rabbits, (16-24 females/group), OECD TG 414 | 0, 25, 100 and 250 mg/kg bw/day, GD 7-19 | Maternal toxicity At 250 mg/kg bw/day, 5 females died due to treatment-related effects within the gastrointestinal tract, clinical signs such as decreased amount of faeces, perineal soiling and...","duration":"Prenatal","effect":"Unlabeled table on page 75: Prenatal developmental toxicity via gavage in New Zealand White rabbits, (16-24 females/group), OECD TG 414 | 0, 25, 100 and 250 mg/kg bw/day, GD 7-19 | Maternal toxicity At 250 mg/kg bw/day, 5 females died due to treatment-related effects within the gastrointestinal tract, clinical signs such as decreased amount of faeces, perineal soiling and blood in pan were observed. Treatment-related effects on the kidneys, ulceration, and haemorrhage of the gastric mucosa, haemolysed blood within intestinal tract and ↓ content and ↑ fluidity of ingesta, histopathological changes of kidney were observed. Reproductive and litter parameters At 250 mg/kg bw/day, ↑ % litters with resorptions, ↑ number of resorptions/ litters, ↑ post implantation loss, At 100 mg/kg bw/day, ↑ % litters with resorptions, ↑ number of resorptions/ litters, ↑ post implantation loss. | NOAEL (maternal): 100 mg/kg bw/day NOAEL (developmental): 25 mg mg/kg bw/dayj | Zablotny et al.,1991, in (Cal EPA, 2007; EC, 2023; ECHA, 2023b; ECHA RAC, 2022; EU CAR, 2015; Health Canada, 2020; SCCS, 2015; US...","endpoint":"reproductive toxicity","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"100","page":75,"route":"oral","species":"rabbit","study_id":"sccs_o_291_noael_133"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies reproductive toxicity 100 mg/kg bw/day mouse oral Prenatal reproductive toxicity SOURCE_SUBDIR=sccs_o_291; REPORT_TITLE=OPINION on Biphenyl-2-ol and Sodium 2-biphenylolate (OPP & SOPP) used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6); OPINION_NUMBER=SCCS/1669/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=100; DOSE=Prenatal developmental toxicity via gavage in JCL- ICR mice, (20 females/group), similar to OCED TG 414 | 0, 100, 200 and 400 mg/ kg bw/ day, GD 7-15 | Maternal toxicity At 400 mg/kg bw/day, ↑ mortality (80% of unscheduled deaths), ↓ body weight and body weight gain, ↓ absolute weight of liver, heart, and spleen.; LOAEL_VALUE=100 mg/kg bw/day; EFFECT=Unlabeled table on page 76: Prenatal developmental toxicity via gavage in JCL- ICR mice, (20 females/group), similar to OCED TG 414 | 0, 100, 200 and 400 mg/ kg bw/ day, GD 7-15 | Maternal toxicity At 400 mg/kg bw/day, ↑ mortality (80% of unscheduled deaths), ↓ body weight and body weight gain, ↓ absolute weight of liver, heart, and spleen. At 200 mg/kg bw/day, ↑ mortality (20% of unscheduled deaths), ↓ body weight and body weight gain, ↑ relative lung weight at 100 mg/kg bw/day, ↓ body weight and body weight gain Litter/reproductive data: At 400 mg/kg bw/day, ↓ foetal body weight, ↑ frequency of foetuses with cervical ribs, ↓ mean number of ossified left/right phalanges in forelegs and posterior lumbar vertebrae At 200 mg/kg bw/day, ↓ number of implantation sites/dam, ↓ litter size (live foetuses), ↓ foetal body weight, ↓ mean number of ossified left/right phalanges in forelegs and hindlegs At 100 mg/kg bw/day, ↓ foetal body weight, ↓ mean number of ossified left/right phalanges in forelegs and hindlegs. | LOAEL (maternal and foetal toxicity): 100 mg/kg bw/day | Ogata et al., 197...; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"90-43-7","citation":"","dose":"Prenatal developmental toxicity via gavage in JCL- ICR mice, (20 females/group), similar to OCED TG 414 | 0, 100, 200 and 400 mg/ kg bw/ day, GD 7-15 | Maternal toxicity At 400 mg/kg bw/day, ↑ mortality (80% of unscheduled deaths), ↓ body weight and body weight gain, ↓ absolute weight of liver, heart, and spleen.","duration":"Prenatal","effect":"Unlabeled table on page 76: Prenatal developmental toxicity via gavage in JCL- ICR mice, (20 females/group), similar to OCED TG 414 | 0, 100, 200 and 400 mg/ kg bw/ day, GD 7-15 | Maternal toxicity At 400 mg/kg bw/day, ↑ mortality (80% of unscheduled deaths), ↓ body weight and body weight gain, ↓ absolute weight of liver, heart, and spleen. At 200 mg/kg bw/day, ↑ mortality (20% of unscheduled deaths), ↓ body weight and body weight gain, ↑ relative lung weight at 100 mg/kg bw/day, ↓ body weight and body weight gain Litter/reproductive data: At 400 mg/kg bw/day, ↓ foetal body weight, ↑ frequency of foetuses with cervical ribs, ↓ mean number of ossified left/right phalanges in forelegs and posterior lumbar vertebrae At 200 mg/kg bw/day, ↓ number of implantation sites/dam, ↓ litter size (live foetuses), ↓ foetal body weight, ↓ mean number of ossified left/right phalanges in forelegs and hindlegs At 100 mg/kg bw/day, ↓ foetal body weight, ↓ mean number of ossified left/right phalanges in forelegs and hindlegs. | LOAEL (maternal and foetal toxicity): 100 mg/kg bw/day | Ogata et al., 197...","endpoint":"reproductive toxicity","ingredient":"s, toys, textiles, clothing,","loael_value":"100 mg/kg bw/day","noael_unit":"mg/kg bw/day","noael_value":"100","page":76,"route":"oral","species":"mouse","study_id":"sccs_o_291_noael_135"}
openFDA substances 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
openFDA substances FDA UNII substance identifier D343Z75HT8 UNII - - - chemical {"approval_status":null,"molecular_formula":"C12H10O","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"D343Z75HT8"}
openFDA substances FDA UNII substance identifier D343Z75HT8 UNII - - - chemical {"approval_status":null,"molecular_formula":"C12H10O","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"D343Z75HT8"}
openFDA substances FDA UNII substance identifier D343Z75HT8 UNII - - - chemical {"approval_status":null,"molecular_formula":"C12H10O","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"D343Z75HT8"}
openFDA substances FDA UNII substance identifier D343Z75HT8 UNII - - - chemical {"approval_status":null,"molecular_formula":"C12H10O","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"D343Z75HT8"}