NOAEL Studies Cosmetic Ingredient

HC Red No. 13 NOAEL Studies

INCI: HC RED NO. 13

CAS: 94158-13-1

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

Back to parent ingredient page
COSMOS_DB 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
COSMOS_DB LOAEL 75 mg/kg bw/day rat oral 90 day Subchronic SCCS; Weide, J.; Three-month toxicity test in rats with the test substance Kardinalrot (Part1); WELLA AG; 1985
SCCS_vision_codex 52 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
SCCS_vision_codex NOAEL =5 mg/kg bw rat - 90-day dermal absorption {"dose":"In the 90-day studies with rats, 5 mg/kg bw C.P. is considered to be the NOAEL.","effect":"2,2’-[(4-Amino-3- nitrophenyl)imino]-bisethanol hydrochloride was submitted in July 1992 by COLIPA 1, 2. Submission II for HC Red n° 13 was submitted in April 1995 by COLIPA 2. The Scientific Committee on Cosmetology (SCC) adopted at its 62nd plenary meeting on 18 January 1996 an opinion (SCC/106/92) with the final conclusion that: “The irritation tests showed no harmful effects. The substance (C.P. 3) can be classified as non-sensitizer. In the 90-day studies with rats, 5 mg/kg bw C.P. is considered to be the NOAEL. In the teratogenicity study, no signs of maternal or foetal toxicity were observed in the rat after administration of 30 mg/kg bw (NOAEL). It should be noted that the NOAEL stems from a daily exposure for 90 days, whereas human exposure to permanent hair dye is unlikely to be more frequent than once a month. Percutaneous absorption of a formulation was about 0.05.” The substance is currently regulated by the Cosmetics Directive (76/768/EC), Annex III, Part 2 under entry 31 on the list of substances, provisionall","page":5,"pdf":"sccp_o_104.pdf","row_type":"noael_study","study_id":"sccp_o_104_noael_001"}
SCCS_vision_codex NOAEL =30 mg/kg bw rat - 90-day dermal absorption {"dose":"In the 90-day studies with rats, 5 mg/kg bw C.P. is considered to be the NOAEL.","effect":"was submitted in April 1995 by COLIPA 2. The Scientific Committee on Cosmetology (SCC) adopted at its 62nd plenary meeting on 18 January 1996 an opinion (SCC/106/92) with the final conclusion that: “The irritation tests showed no harmful effects. The substance (C.P. 3) can be classified as non-sensitizer. In the 90-day studies with rats, 5 mg/kg bw C.P. is considered to be the NOAEL. In the teratogenicity study, no signs of maternal or foetal toxicity were observed in the rat after administration of 30 mg/kg bw (NOAEL). It should be noted that the NOAEL stems from a daily exposure for 90 days, whereas human exposure to permanent hair dye is unlikely to be more frequent than once a month. Percutaneous absorption of a formulation was about 0.05.” The substance is currently regulated by the Cosmetics Directive (76/768/EC), Annex III, Part 2 under entry 31 on the list of substances, provisionally allowed, which cosmetic products must not contain except subject to restrictions and conditions laid down. Submission III for HC Red n°","page":5,"pdf":"sccp_o_104.pdf","row_type":"noael_study","study_id":"sccp_o_104_noael_002"}
SCCS_vision_codex NOAEL =300 mg/kg/day rat oral 13 weeks NOAEL study {"citation":"Ref.: 22 Study 2 Guideline: OECD 408 (1981) Species/strain: Wistar rats, strain Bor","dose":"howed an activation of thyroid epithelium at doses of 150 and 300 mg/kg/day with increased intensity, accompanied by an enlargement of epithelium cell nuclei at the higher dose.","effect":"howed an activation of thyroid epithelium at doses of 150 and 300 mg/kg/day with increased intensity, accompanied by an enlargement of epithelium cell nuclei at the higher dose. This substance-related effect was restricted to males (4 in group III, 5 in group IV and 4 in group V). Furthermore a liver cell hypertrophy was observed in animals treated with 300 mg/kg/day (8 in group IV and 5 in group V after recovery period). In group V an increase of lipocytes in bone marrows was noted in 5/10 animals. Conclusion No NOAEL could be established. Ref.: 22 Study 2 Guideline: OECD 408 (1981) Species/strain: Wistar rats, strain Bor.Wis.W. (SPF) Group size: 12 animals per sex and group Test substance: Kardinalrot Batch number: / Purity: 82%, 17% water Dose levels: 0, 10 mg/kg bw/day in de-ionised water by gavage Exposure period: 13 weeks GLP: in compliance The test substance (dissolved in water) was administered by oral gavage once daily to a group of 24 Wistar rats (Bor (Wi)W, SPF) (12/sex) at 10 mg/kg/day (group II) for 90 days, 24","page":21,"pdf":"sccp_o_104.pdf","row_type":"noael_study","study_id":"sccp_o_104_noael_004"}
SCCS_vision_codex NOAEL =84 % rat oral 13 weeks NOAEL study {"citation":"Ref.: 23 Study 3 Guideline: OECD 408 (1981) Species/strain: Sprague-Dawley CFY rats Group size: 10 animals per sex and group Test substance: Kardinalrot Batch number: / Purity: 84% (13%","dose":"84% (13% 1-β-hydroxyethylamino-2-nitro-4-bis-(β- hydroxyethyl)amino- benzene and 3% 1-amino-2-nitro-4-(β- hydroxyethyl)aminobenzene Dose levels:","effect":"imals was discoloured. - Organ weights: Absolute and relative organ weight of the spleen was reduced in the females of the test group, whereas the relative spleen weight and the relative weight of the kidney were increased significantly in the corresponding males. - Histopathology: The histomorphological examination revealed a slight activation of the thyroids in 10 male and 1 female rat of the test group. As another substance-related effect lymphatic enteritis was observed in 10 animals of group II Conclusion No NOAEL could be established. Ref.: 23 Study 3 Guideline: OECD 408 (1981) Species/strain: Sprague-Dawley CFY rats Group size: 10 animals per sex and group Test substance: Kardinalrot Batch number: / Purity: 84% (13% 1-β-hydroxyethylamino-2-nitro-4-bis-(β- hydroxyethyl)amino- benzene and 3% 1-amino-2-nitro-4-(β- hydroxyethyl)aminobenzene Dose levels: 0, 5 mg/kg bw/day in de-ionised water by gavage Exposure period: 13 weeks GLP: in compliance The test substance (dissolved in water) was administered by gavage once daily","page":22,"pdf":"sccp_o_104.pdf","row_type":"noael_study","study_id":"sccp_o_104_noael_005"}
SCCS_vision_codex NOAEL =300 mg/kg bw rat oral 90-day reproductive toxicity {"citation":"Ref.: 22)","dose":"hyroid was noted in parental animals of either sex (predominantly in males) in all dose groups.","effect":"hyroid was noted in parental animals of either sex (predominantly in males) in all dose groups. These effects in the parental animals were related to the treatment with the test substance. Conclusion At the highest test dose, clinical signs in terms of discomfort were noted in both males and females. Similar to the findings in the 90-day study an increase in follicular cell hypertrophy in the thyroid was noted (see Ref.: 22). HC Red n° 13 did not reveal any effect on any reproduction parameter. From this study, a NOAEL of 300 mg/kg bw for reproductive effects was deduced. Ref.: 32 3.3.8.2. Teratogenicity Old study, taken from opinion n° XXIV/1287/97 of 20 May 1998 The test substance (dissolved in water) was given daily from day 5-15 of gestation to groups of 24 pregnant Wistar rats, respectively, (Bor:Wisw-SPF TNO strain) by oral gavage of doses of 5 (group I), 15 (group II) and 30 (group III) mg/kg bw. 24 pregnant females treated with aqua deionised served as controls. Prior to treatment females were 14 weeks old and had a b","page":30,"pdf":"sccp_o_104.pdf","row_type":"noael_study","study_id":"sccp_o_104_noael_006"}
SCCS_vision_codex NOAEL =30 mg/kg rat oral - NOAEL study {"dose":"Thus the NOAEL is 30 mg/kg.","effect":"foetuses, distribution and site in the uterus, early and late resorptions, placentas, implantations, sex determination, corpora lutea. - Determination of the weight of foetuses, placentas, graved uteri, uteri without foetuses. - Externally visible deviations in foetuses, organic imperfections (in 1/3 of all foetuses) and skeletal defects (in 2/3 of all foetuses) were evaluated. Results No maternal abnormalities and no signs of maternal toxicity were observed. No abnormalities were found in the foetuses. Thus the NOAEL is 30 mg/kg. New study Guideline: OECD 414 (1984) Species/strain: HanBri: WIST (SPF quality) rats Group size: 22 mated females per dose group Test substance: HC Red No. 13 (WR 23020) in bi-distilled water Batch number: 4/5/6-1 Fass 3 (Fa. Robinson) Purity: 98.4 % (HPLC at 254 nm) Dose levels: 0, 30, 100 and 300 mg /kg/day (oral, gavage) Treatment period: once daily, day 6 - 20 of gestation GLP: In compliance","page":30,"pdf":"sccp_o_104.pdf","row_type":"noael_study","study_id":"sccp_o_104_noael_007"}
SCCS_vision_codex NOAEL =4.2 mg/kg bw/day rat dermal 90-day reproductive toxicity {"dose":"General toxicity LD50 was calculated to be 2120 (1810 - 2480) mg/kg bw.","effect":"0 ppb. No documentation was provided to support the data presented in the table \"Batch comparison\" The stability of the test substance in marketed products was not reported. General toxicity LD50 was calculated to be 2120 (1810 - 2480) mg/kg bw. Based on the effects seen in the 90-day study (changes in haematological parameters and clinical chemistry, relative kidney weight), the Lowest Observed Effect Level was considered to be 5 mg/kg bw/day of Kardinalrot, corresponding to 4.2 mg/kg bw/day of HC Red n° 13. The NOAEL for reproductive effects was set at 300 mg/kg bw/day. A NOAEL of 300 mg/kg bw/day for both materno-toxic and for embryo-foetal effects was deduced. Toxicokinetics In vitro, HC Red n° 13 revealed a Papp of 37.1 x 10-6 cm/sec and thus was classified to be of high permeability. The observed value indicates a good absorption from the gastro- intestinal tract. After dermal application in rats, only minor amounts of HC Red n° 13 are absorbed through the skin and become systemically available. If applied in a hair dye","page":33,"pdf":"sccp_o_104.pdf","row_type":"noael_study","study_id":"sccp_o_104_noael_009"}
SCCS_vision_codex NOAEL =300 mg/kg bw/day rat dermal 90-day reproductive toxicity {"dose":"General toxicity LD50 was calculated to be 2120 (1810 - 2480) mg/kg bw.","effect":"nted in the table \"Batch comparison\" The stability of the test substance in marketed products was not reported. General toxicity LD50 was calculated to be 2120 (1810 - 2480) mg/kg bw. Based on the effects seen in the 90-day study (changes in haematological parameters and clinical chemistry, relative kidney weight), the Lowest Observed Effect Level was considered to be 5 mg/kg bw/day of Kardinalrot, corresponding to 4.2 mg/kg bw/day of HC Red n° 13. The NOAEL for reproductive effects was set at 300 mg/kg bw/day. A NOAEL of 300 mg/kg bw/day for both materno-toxic and for embryo-foetal effects was deduced. Toxicokinetics In vitro, HC Red n° 13 revealed a Papp of 37.1 x 10-6 cm/sec and thus was classified to be of high permeability. The observed value indicates a good absorption from the gastro- intestinal tract. After dermal application in rats, only minor amounts of HC Red n° 13 are absorbed through the skin and become systemically available. If applied in a hair dye formulation as vehicle less than 1.1 µg/cm2 of the dye formula","page":33,"pdf":"sccp_o_104.pdf","row_type":"noael_study","study_id":"sccp_o_104_noael_010"}
SCCS_vision_codex NOAEL =10 - rat - - NOAEL study {"effect":"imals was discoloured. - Organ weights: Absolute and relative organ weight of the spleen was reduced in the females of the test group, whereas the relative spleen weight and the relative weight of the kidney were increased significantly in the corresponding males. - Histopathology: The histomorphological examination revealed a slight activation of the thyroids in 10 male and 1 female rat of the test group. As another substance-related effect lymphatic enteritis was observed in 10 animals of group II Conclusion No NOAEL could be established.","page":21,"pdf":"sccs_o_040.pdf","row_type":"noael_study","study_id":"sccs_o_040_noael_005"}
SCCS_vision_codex NOAEL =5 mg/kg bw/day - - 34 days repeated dose toxicity {"citation":"Ref.: 24 Conclusion of the SCCS on sub-chronic toxicity At 10 mg/kg bw/day significant haematological, histopathological and spleen weight changes were observed","dose":"24 Conclusion of the SCCS on sub-chronic toxicity At 10 mg/kg bw/day significant haematological, histopathological and spleen weight changes were observed.","effect":"SCCS-rejected applicant NOAEL: f the females during the fist week and on isolated occasions up to 34 days after the start of the study. Ref.: 24 Conclusion of the SCCS on sub-chronic toxicity At 10 mg/kg bw/day significant haematological, histopathological and spleen weight changes were observed. The effects seen at 5 mg/kg bw/day (changes in haematological parameters and clinical chemistry, relative kidney weight), are not considered to be adverse (not consistent, not deviating from the normal range, only relative kidney weight changes). The no observed adverse effect level was therefore considered to be 5 mg/kg bw/day of Kardinalrot, corresponding to 4.2 mg/kg bw/day of HC Red n° 13.","page":22,"pdf":"sccs_o_040.pdf","row_type":"noael_study","study_id":"sccs_o_040_noael_006"}
SCCS_vision_codex NOAEL =0.011 mg/kg bw/d rat oral 90 day dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Red n° 13 (non-oxidative conditions) Absorption through the skin A (mean +2 SD) = 1.17 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.68 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x...","effect":"oclastogenicity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Red n° 13 (non-oxidative conditions) Absorption through the skin A (mean +2 SD) = 1.17 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.68 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.011 mg/kg bw/d No observed adverse effect level NOAEL = 4.2 mg/kg bw/d (90 day, oral, rat) Margin of Safety NOAEL / SED = 382","page":32,"pdf":"sccs_o_040.pdf","row_type":"noael_study","study_id":"sccs_o_040_noael_010"}
SCCS_vision_codex NOAEL =4.2 mg/kg bw/d rat oral 90 day dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Red n° 13 (non-oxidative conditions) Absorption through the skin A (mean +2 SD) = 1.17 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.68 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x...","effect":"d 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Red n° 13 (non-oxidative conditions) Absorption through the skin A (mean +2 SD) = 1.17 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.68 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.011 mg/kg bw/d No observed adverse effect level NOAEL = 4.2 mg/kg bw/d (90 day, oral, rat) Margin of Safety NOAEL / SED = 382","page":32,"pdf":"sccs_o_040.pdf","row_type":"noael_study","study_id":"sccs_o_040_noael_011"}
SCCS_vision_codex NOAEL =0.01 mg/kg bw/d rat oral 90 day dermal absorption {"dose":"SCCS/1368/10 Opinion on HC Red n° 13 ___________________________________________________________________________________________ 33 (oxidative conditions) Absorption through the skin A (mean +2 SD) = 1.03 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.60 mg Typical body weight of human = 60 kg Systemic...","effect":"SCCS/1368/10 Opinion on HC Red n° 13 ___________________________________________________________________________________________ 33 (oxidative conditions) Absorption through the skin A (mean +2 SD) = 1.03 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.60 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.01 mg/kg bw/d No observed adverse effect level NOAEL = 4.2 mg/kg bw/d (90 day, oral, rat) Margin of Safety NOAEL / SED = 420 3.3.14. Discussion Physico-chemical specifications HC Red n° 13 is used as a hair colouring agent in semi-permanent hair dye formulations at a maximum on-head concentration of 2.5%. It is also used in oxidative hair dye formulations at a maximum concentration of 2.5%, which after mixing typically in 1:1 ratio with hydrogen peroxide prior to use, corresponds to a final on-head concentration of 1.25% upon application. Batch 4/5/6-1 Fas","page":33,"pdf":"sccs_o_040.pdf","row_type":"noael_study","study_id":"sccs_o_040_noael_013"}
SCCS_vision_codex NOAEL =5 mg/kg bw rat - 90-day dermal absorption {"dose":"In the 90-day studies with rats, 5 mg/kg bw C.P. is considered to be the NOAEL.","effect":"2,2’-[(4-Amino-3- nitrophenyl)imino]-bisethanol hydrochloride was submitted in July 1992 by COLIPA 1, 2. Submission II for HC Red n° 13 was submitted in April 1995 by COLIPA 2. The Scientific Committee on Cosmetology (SCC) adopted at its 62nd plenary meeting on 18 January 1996 an opinion (SCC/106/92) with the final conclusion that: “The irritation tests showed no harmful effects. The substance (C.P. 3) can be classified as non-sensitizer. In the 90-day studies with rats, 5 mg/kg bw C.P. is considered to be the NOAEL. In the teratogenicity study, no signs of maternal or foetal toxicity were observed in the rat after administration of 30 mg/kg bw (NOAEL). It should be noted that the NOAEL stems from a daily exposure for 90 days, whereas human exposure to permanent hair dye is unlikely to be more frequent than once a month. Percutaneous absorption of a formulation was about 0.05.” The substance is currently regulated by the Cosmetics Directive (76/768/EC), Annex III, Part 2 under entry 31 on the list of substances, provisionall","page":5,"pdf":"sccp_o_104.pdf","row_type":"noael_study","study_id":"sccp_o_104_noael_001"}
SCCS_vision_codex NOAEL =30 mg/kg bw rat - 90-day dermal absorption {"dose":"In the 90-day studies with rats, 5 mg/kg bw C.P. is considered to be the NOAEL.","effect":"was submitted in April 1995 by COLIPA 2. The Scientific Committee on Cosmetology (SCC) adopted at its 62nd plenary meeting on 18 January 1996 an opinion (SCC/106/92) with the final conclusion that: “The irritation tests showed no harmful effects. The substance (C.P. 3) can be classified as non-sensitizer. In the 90-day studies with rats, 5 mg/kg bw C.P. is considered to be the NOAEL. In the teratogenicity study, no signs of maternal or foetal toxicity were observed in the rat after administration of 30 mg/kg bw (NOAEL). It should be noted that the NOAEL stems from a daily exposure for 90 days, whereas human exposure to permanent hair dye is unlikely to be more frequent than once a month. Percutaneous absorption of a formulation was about 0.05.” The substance is currently regulated by the Cosmetics Directive (76/768/EC), Annex III, Part 2 under entry 31 on the list of substances, provisionally allowed, which cosmetic products must not contain except subject to restrictions and conditions laid down. Submission III for HC Red n°","page":5,"pdf":"sccp_o_104.pdf","row_type":"noael_study","study_id":"sccp_o_104_noael_002"}
SCCS_vision_codex NOAEL =300 mg/kg/day rat oral 13 weeks NOAEL study {"citation":"Ref.: 22 Study 2 Guideline: OECD 408 (1981) Species/strain: Wistar rats, strain Bor","dose":"howed an activation of thyroid epithelium at doses of 150 and 300 mg/kg/day with increased intensity, accompanied by an enlargement of epithelium cell nuclei at the higher dose.","effect":"howed an activation of thyroid epithelium at doses of 150 and 300 mg/kg/day with increased intensity, accompanied by an enlargement of epithelium cell nuclei at the higher dose. This substance-related effect was restricted to males (4 in group III, 5 in group IV and 4 in group V). Furthermore a liver cell hypertrophy was observed in animals treated with 300 mg/kg/day (8 in group IV and 5 in group V after recovery period). In group V an increase of lipocytes in bone marrows was noted in 5/10 animals. Conclusion No NOAEL could be established. Ref.: 22 Study 2 Guideline: OECD 408 (1981) Species/strain: Wistar rats, strain Bor.Wis.W. (SPF) Group size: 12 animals per sex and group Test substance: Kardinalrot Batch number: / Purity: 82%, 17% water Dose levels: 0, 10 mg/kg bw/day in de-ionised water by gavage Exposure period: 13 weeks GLP: in compliance The test substance (dissolved in water) was administered by oral gavage once daily to a group of 24 Wistar rats (Bor (Wi)W, SPF) (12/sex) at 10 mg/kg/day (group II) for 90 days, 24","page":21,"pdf":"sccp_o_104.pdf","row_type":"noael_study","study_id":"sccp_o_104_noael_004"}
SCCS_vision_codex NOAEL =84 % rat oral 13 weeks NOAEL study {"citation":"Ref.: 23 Study 3 Guideline: OECD 408 (1981) Species/strain: Sprague-Dawley CFY rats Group size: 10 animals per sex and group Test substance: Kardinalrot Batch number: / Purity: 84% (13%","dose":"84% (13% 1-β-hydroxyethylamino-2-nitro-4-bis-(β- hydroxyethyl)amino- benzene and 3% 1-amino-2-nitro-4-(β- hydroxyethyl)aminobenzene Dose levels:","effect":"imals was discoloured. - Organ weights: Absolute and relative organ weight of the spleen was reduced in the females of the test group, whereas the relative spleen weight and the relative weight of the kidney were increased significantly in the corresponding males. - Histopathology: The histomorphological examination revealed a slight activation of the thyroids in 10 male and 1 female rat of the test group. As another substance-related effect lymphatic enteritis was observed in 10 animals of group II Conclusion No NOAEL could be established. Ref.: 23 Study 3 Guideline: OECD 408 (1981) Species/strain: Sprague-Dawley CFY rats Group size: 10 animals per sex and group Test substance: Kardinalrot Batch number: / Purity: 84% (13% 1-β-hydroxyethylamino-2-nitro-4-bis-(β- hydroxyethyl)amino- benzene and 3% 1-amino-2-nitro-4-(β- hydroxyethyl)aminobenzene Dose levels: 0, 5 mg/kg bw/day in de-ionised water by gavage Exposure period: 13 weeks GLP: in compliance The test substance (dissolved in water) was administered by gavage once daily","page":22,"pdf":"sccp_o_104.pdf","row_type":"noael_study","study_id":"sccp_o_104_noael_005"}
SCCS_vision_codex NOAEL =300 mg/kg bw rat oral 90-day reproductive toxicity {"citation":"Ref.: 22)","dose":"hyroid was noted in parental animals of either sex (predominantly in males) in all dose groups.","effect":"hyroid was noted in parental animals of either sex (predominantly in males) in all dose groups. These effects in the parental animals were related to the treatment with the test substance. Conclusion At the highest test dose, clinical signs in terms of discomfort were noted in both males and females. Similar to the findings in the 90-day study an increase in follicular cell hypertrophy in the thyroid was noted (see Ref.: 22). HC Red n° 13 did not reveal any effect on any reproduction parameter. From this study, a NOAEL of 300 mg/kg bw for reproductive effects was deduced. Ref.: 32 3.3.8.2. Teratogenicity Old study, taken from opinion n° XXIV/1287/97 of 20 May 1998 The test substance (dissolved in water) was given daily from day 5-15 of gestation to groups of 24 pregnant Wistar rats, respectively, (Bor:Wisw-SPF TNO strain) by oral gavage of doses of 5 (group I), 15 (group II) and 30 (group III) mg/kg bw. 24 pregnant females treated with aqua deionised served as controls. Prior to treatment females were 14 weeks old and had a b","page":30,"pdf":"sccp_o_104.pdf","row_type":"noael_study","study_id":"sccp_o_104_noael_006"}
SCCS_vision_codex NOAEL =30 mg/kg rat oral - NOAEL study {"dose":"Thus the NOAEL is 30 mg/kg.","effect":"foetuses, distribution and site in the uterus, early and late resorptions, placentas, implantations, sex determination, corpora lutea. - Determination of the weight of foetuses, placentas, graved uteri, uteri without foetuses. - Externally visible deviations in foetuses, organic imperfections (in 1/3 of all foetuses) and skeletal defects (in 2/3 of all foetuses) were evaluated. Results No maternal abnormalities and no signs of maternal toxicity were observed. No abnormalities were found in the foetuses. Thus the NOAEL is 30 mg/kg. New study Guideline: OECD 414 (1984) Species/strain: HanBri: WIST (SPF quality) rats Group size: 22 mated females per dose group Test substance: HC Red No. 13 (WR 23020) in bi-distilled water Batch number: 4/5/6-1 Fass 3 (Fa. Robinson) Purity: 98.4 % (HPLC at 254 nm) Dose levels: 0, 30, 100 and 300 mg /kg/day (oral, gavage) Treatment period: once daily, day 6 - 20 of gestation GLP: In compliance","page":30,"pdf":"sccp_o_104.pdf","row_type":"noael_study","study_id":"sccp_o_104_noael_007"}
SCCS_vision_codex NOAEL =4.2 mg/kg bw/day rat dermal 90-day reproductive toxicity {"dose":"General toxicity LD50 was calculated to be 2120 (1810 - 2480) mg/kg bw.","effect":"0 ppb. No documentation was provided to support the data presented in the table \"Batch comparison\" The stability of the test substance in marketed products was not reported. General toxicity LD50 was calculated to be 2120 (1810 - 2480) mg/kg bw. Based on the effects seen in the 90-day study (changes in haematological parameters and clinical chemistry, relative kidney weight), the Lowest Observed Effect Level was considered to be 5 mg/kg bw/day of Kardinalrot, corresponding to 4.2 mg/kg bw/day of HC Red n° 13. The NOAEL for reproductive effects was set at 300 mg/kg bw/day. A NOAEL of 300 mg/kg bw/day for both materno-toxic and for embryo-foetal effects was deduced. Toxicokinetics In vitro, HC Red n° 13 revealed a Papp of 37.1 x 10-6 cm/sec and thus was classified to be of high permeability. The observed value indicates a good absorption from the gastro- intestinal tract. After dermal application in rats, only minor amounts of HC Red n° 13 are absorbed through the skin and become systemically available. If applied in a hair dye","page":33,"pdf":"sccp_o_104.pdf","row_type":"noael_study","study_id":"sccp_o_104_noael_009"}
SCCS_vision_codex NOAEL =300 mg/kg bw/day rat dermal 90-day reproductive toxicity {"dose":"General toxicity LD50 was calculated to be 2120 (1810 - 2480) mg/kg bw.","effect":"nted in the table \"Batch comparison\" The stability of the test substance in marketed products was not reported. General toxicity LD50 was calculated to be 2120 (1810 - 2480) mg/kg bw. Based on the effects seen in the 90-day study (changes in haematological parameters and clinical chemistry, relative kidney weight), the Lowest Observed Effect Level was considered to be 5 mg/kg bw/day of Kardinalrot, corresponding to 4.2 mg/kg bw/day of HC Red n° 13. The NOAEL for reproductive effects was set at 300 mg/kg bw/day. A NOAEL of 300 mg/kg bw/day for both materno-toxic and for embryo-foetal effects was deduced. Toxicokinetics In vitro, HC Red n° 13 revealed a Papp of 37.1 x 10-6 cm/sec and thus was classified to be of high permeability. The observed value indicates a good absorption from the gastro- intestinal tract. After dermal application in rats, only minor amounts of HC Red n° 13 are absorbed through the skin and become systemically available. If applied in a hair dye formulation as vehicle less than 1.1 µg/cm2 of the dye formula","page":33,"pdf":"sccp_o_104.pdf","row_type":"noael_study","study_id":"sccp_o_104_noael_010"}
SCCS_vision_codex NOAEL =5 mg/kg bw rat - 90-day dermal absorption {"dose":"In the 90-day studies with rats, 5 mg/kg bw C.P. is considered to be the NOAEL.","effect":"2,2’-[(4-Amino-3- nitrophenyl)imino]-bisethanol hydrochloride was submitted in July 1992 by COLIPA 1, 2. Submission II for HC Red n° 13 was submitted in April 1995 by COLIPA 2. The Scientific Committee on Cosmetology (SCC) adopted at its 62nd plenary meeting on 18 January 1996 an opinion (SCC/106/92) with the final conclusion that: “The irritation tests showed no harmful effects. The substance (C.P. 3) can be classified as non-sensitizer. In the 90-day studies with rats, 5 mg/kg bw C.P. is considered to be the NOAEL. In the teratogenicity study, no signs of maternal or foetal toxicity were observed in the rat after administration of 30 mg/kg bw (NOAEL). It should be noted that the NOAEL stems from a daily exposure for 90 days, whereas human exposure to permanent hair dye is unlikely to be more frequent than once a month. Percutaneous absorption of a formulation was about 0.05.” The substance is currently regulated by the Cosmetics Directive (76/768/EC), Annex III, Part 2 under entry 31 on the list of substances, provisionall","page":5,"pdf":"sccp_o_104.pdf","row_type":"noael_study","study_id":"sccp_o_104_noael_001"}
SCCS_vision_codex NOAEL =30 mg/kg bw rat - 90-day dermal absorption {"dose":"In the 90-day studies with rats, 5 mg/kg bw C.P. is considered to be the NOAEL.","effect":"was submitted in April 1995 by COLIPA 2. The Scientific Committee on Cosmetology (SCC) adopted at its 62nd plenary meeting on 18 January 1996 an opinion (SCC/106/92) with the final conclusion that: “The irritation tests showed no harmful effects. The substance (C.P. 3) can be classified as non-sensitizer. In the 90-day studies with rats, 5 mg/kg bw C.P. is considered to be the NOAEL. In the teratogenicity study, no signs of maternal or foetal toxicity were observed in the rat after administration of 30 mg/kg bw (NOAEL). It should be noted that the NOAEL stems from a daily exposure for 90 days, whereas human exposure to permanent hair dye is unlikely to be more frequent than once a month. Percutaneous absorption of a formulation was about 0.05.” The substance is currently regulated by the Cosmetics Directive (76/768/EC), Annex III, Part 2 under entry 31 on the list of substances, provisionally allowed, which cosmetic products must not contain except subject to restrictions and conditions laid down. Submission III for HC Red n°","page":5,"pdf":"sccp_o_104.pdf","row_type":"noael_study","study_id":"sccp_o_104_noael_002"}
SCCS_vision_codex NOAEL =300 mg/kg/day rat oral 13 weeks NOAEL study {"citation":"Ref.: 22 Study 2 Guideline: OECD 408 (1981) Species/strain: Wistar rats, strain Bor","dose":"howed an activation of thyroid epithelium at doses of 150 and 300 mg/kg/day with increased intensity, accompanied by an enlargement of epithelium cell nuclei at the higher dose.","effect":"howed an activation of thyroid epithelium at doses of 150 and 300 mg/kg/day with increased intensity, accompanied by an enlargement of epithelium cell nuclei at the higher dose. This substance-related effect was restricted to males (4 in group III, 5 in group IV and 4 in group V). Furthermore a liver cell hypertrophy was observed in animals treated with 300 mg/kg/day (8 in group IV and 5 in group V after recovery period). In group V an increase of lipocytes in bone marrows was noted in 5/10 animals. Conclusion No NOAEL could be established. Ref.: 22 Study 2 Guideline: OECD 408 (1981) Species/strain: Wistar rats, strain Bor.Wis.W. (SPF) Group size: 12 animals per sex and group Test substance: Kardinalrot Batch number: / Purity: 82%, 17% water Dose levels: 0, 10 mg/kg bw/day in de-ionised water by gavage Exposure period: 13 weeks GLP: in compliance The test substance (dissolved in water) was administered by oral gavage once daily to a group of 24 Wistar rats (Bor (Wi)W, SPF) (12/sex) at 10 mg/kg/day (group II) for 90 days, 24","page":21,"pdf":"sccp_o_104.pdf","row_type":"noael_study","study_id":"sccp_o_104_noael_004"}
SCCS_vision_codex NOAEL =84 % rat oral 13 weeks NOAEL study {"citation":"Ref.: 23 Study 3 Guideline: OECD 408 (1981) Species/strain: Sprague-Dawley CFY rats Group size: 10 animals per sex and group Test substance: Kardinalrot Batch number: / Purity: 84% (13%","dose":"84% (13% 1-β-hydroxyethylamino-2-nitro-4-bis-(β- hydroxyethyl)amino- benzene and 3% 1-amino-2-nitro-4-(β- hydroxyethyl)aminobenzene Dose levels:","effect":"imals was discoloured. - Organ weights: Absolute and relative organ weight of the spleen was reduced in the females of the test group, whereas the relative spleen weight and the relative weight of the kidney were increased significantly in the corresponding males. - Histopathology: The histomorphological examination revealed a slight activation of the thyroids in 10 male and 1 female rat of the test group. As another substance-related effect lymphatic enteritis was observed in 10 animals of group II Conclusion No NOAEL could be established. Ref.: 23 Study 3 Guideline: OECD 408 (1981) Species/strain: Sprague-Dawley CFY rats Group size: 10 animals per sex and group Test substance: Kardinalrot Batch number: / Purity: 84% (13% 1-β-hydroxyethylamino-2-nitro-4-bis-(β- hydroxyethyl)amino- benzene and 3% 1-amino-2-nitro-4-(β- hydroxyethyl)aminobenzene Dose levels: 0, 5 mg/kg bw/day in de-ionised water by gavage Exposure period: 13 weeks GLP: in compliance The test substance (dissolved in water) was administered by gavage once daily","page":22,"pdf":"sccp_o_104.pdf","row_type":"noael_study","study_id":"sccp_o_104_noael_005"}
SCCS_vision_codex NOAEL =300 mg/kg bw rat oral 90-day reproductive toxicity {"citation":"Ref.: 22)","dose":"hyroid was noted in parental animals of either sex (predominantly in males) in all dose groups.","effect":"hyroid was noted in parental animals of either sex (predominantly in males) in all dose groups. These effects in the parental animals were related to the treatment with the test substance. Conclusion At the highest test dose, clinical signs in terms of discomfort were noted in both males and females. Similar to the findings in the 90-day study an increase in follicular cell hypertrophy in the thyroid was noted (see Ref.: 22). HC Red n° 13 did not reveal any effect on any reproduction parameter. From this study, a NOAEL of 300 mg/kg bw for reproductive effects was deduced. Ref.: 32 3.3.8.2. Teratogenicity Old study, taken from opinion n° XXIV/1287/97 of 20 May 1998 The test substance (dissolved in water) was given daily from day 5-15 of gestation to groups of 24 pregnant Wistar rats, respectively, (Bor:Wisw-SPF TNO strain) by oral gavage of doses of 5 (group I), 15 (group II) and 30 (group III) mg/kg bw. 24 pregnant females treated with aqua deionised served as controls. Prior to treatment females were 14 weeks old and had a b","page":30,"pdf":"sccp_o_104.pdf","row_type":"noael_study","study_id":"sccp_o_104_noael_006"}
SCCS_vision_codex NOAEL =30 mg/kg rat oral - NOAEL study {"dose":"Thus the NOAEL is 30 mg/kg.","effect":"foetuses, distribution and site in the uterus, early and late resorptions, placentas, implantations, sex determination, corpora lutea. - Determination of the weight of foetuses, placentas, graved uteri, uteri without foetuses. - Externally visible deviations in foetuses, organic imperfections (in 1/3 of all foetuses) and skeletal defects (in 2/3 of all foetuses) were evaluated. Results No maternal abnormalities and no signs of maternal toxicity were observed. No abnormalities were found in the foetuses. Thus the NOAEL is 30 mg/kg. New study Guideline: OECD 414 (1984) Species/strain: HanBri: WIST (SPF quality) rats Group size: 22 mated females per dose group Test substance: HC Red No. 13 (WR 23020) in bi-distilled water Batch number: 4/5/6-1 Fass 3 (Fa. Robinson) Purity: 98.4 % (HPLC at 254 nm) Dose levels: 0, 30, 100 and 300 mg /kg/day (oral, gavage) Treatment period: once daily, day 6 - 20 of gestation GLP: In compliance","page":30,"pdf":"sccp_o_104.pdf","row_type":"noael_study","study_id":"sccp_o_104_noael_007"}
SCCS_vision_codex NOAEL =4.2 mg/kg bw/day rat dermal 90-day reproductive toxicity {"dose":"General toxicity LD50 was calculated to be 2120 (1810 - 2480) mg/kg bw.","effect":"0 ppb. No documentation was provided to support the data presented in the table \"Batch comparison\" The stability of the test substance in marketed products was not reported. General toxicity LD50 was calculated to be 2120 (1810 - 2480) mg/kg bw. Based on the effects seen in the 90-day study (changes in haematological parameters and clinical chemistry, relative kidney weight), the Lowest Observed Effect Level was considered to be 5 mg/kg bw/day of Kardinalrot, corresponding to 4.2 mg/kg bw/day of HC Red n° 13. The NOAEL for reproductive effects was set at 300 mg/kg bw/day. A NOAEL of 300 mg/kg bw/day for both materno-toxic and for embryo-foetal effects was deduced. Toxicokinetics In vitro, HC Red n° 13 revealed a Papp of 37.1 x 10-6 cm/sec and thus was classified to be of high permeability. The observed value indicates a good absorption from the gastro- intestinal tract. After dermal application in rats, only minor amounts of HC Red n° 13 are absorbed through the skin and become systemically available. If applied in a hair dye","page":33,"pdf":"sccp_o_104.pdf","row_type":"noael_study","study_id":"sccp_o_104_noael_009"}
SCCS_vision_codex NOAEL =300 mg/kg bw/day rat dermal 90-day reproductive toxicity {"dose":"General toxicity LD50 was calculated to be 2120 (1810 - 2480) mg/kg bw.","effect":"nted in the table \"Batch comparison\" The stability of the test substance in marketed products was not reported. General toxicity LD50 was calculated to be 2120 (1810 - 2480) mg/kg bw. Based on the effects seen in the 90-day study (changes in haematological parameters and clinical chemistry, relative kidney weight), the Lowest Observed Effect Level was considered to be 5 mg/kg bw/day of Kardinalrot, corresponding to 4.2 mg/kg bw/day of HC Red n° 13. The NOAEL for reproductive effects was set at 300 mg/kg bw/day. A NOAEL of 300 mg/kg bw/day for both materno-toxic and for embryo-foetal effects was deduced. Toxicokinetics In vitro, HC Red n° 13 revealed a Papp of 37.1 x 10-6 cm/sec and thus was classified to be of high permeability. The observed value indicates a good absorption from the gastro- intestinal tract. After dermal application in rats, only minor amounts of HC Red n° 13 are absorbed through the skin and become systemically available. If applied in a hair dye formulation as vehicle less than 1.1 µg/cm2 of the dye formula","page":33,"pdf":"sccp_o_104.pdf","row_type":"noael_study","study_id":"sccp_o_104_noael_010"}
SCCS_vision_codex NOAEL =10 - rat - - NOAEL study {"effect":"imals was discoloured. - Organ weights: Absolute and relative organ weight of the spleen was reduced in the females of the test group, whereas the relative spleen weight and the relative weight of the kidney were increased significantly in the corresponding males. - Histopathology: The histomorphological examination revealed a slight activation of the thyroids in 10 male and 1 female rat of the test group. As another substance-related effect lymphatic enteritis was observed in 10 animals of group II Conclusion No NOAEL could be established.","page":21,"pdf":"sccs_o_040.pdf","row_type":"noael_study","study_id":"sccs_o_040_noael_005"}
SCCS_vision_codex NOAEL =5 mg/kg bw/day - - 34 days repeated dose toxicity {"citation":"Ref.: 24 Conclusion of the SCCS on sub-chronic toxicity At 10 mg/kg bw/day significant haematological, histopathological and spleen weight changes were observed","dose":"24 Conclusion of the SCCS on sub-chronic toxicity At 10 mg/kg bw/day significant haematological, histopathological and spleen weight changes were observed.","effect":"SCCS-rejected applicant NOAEL: f the females during the fist week and on isolated occasions up to 34 days after the start of the study. Ref.: 24 Conclusion of the SCCS on sub-chronic toxicity At 10 mg/kg bw/day significant haematological, histopathological and spleen weight changes were observed. The effects seen at 5 mg/kg bw/day (changes in haematological parameters and clinical chemistry, relative kidney weight), are not considered to be adverse (not consistent, not deviating from the normal range, only relative kidney weight changes). The no observed adverse effect level was therefore considered to be 5 mg/kg bw/day of Kardinalrot, corresponding to 4.2 mg/kg bw/day of HC Red n° 13.","page":22,"pdf":"sccs_o_040.pdf","row_type":"noael_study","study_id":"sccs_o_040_noael_006"}
SCCS_vision_codex NOAEL =0.011 mg/kg bw/d rat oral 90 day dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Red n° 13 (non-oxidative conditions) Absorption through the skin A (mean +2 SD) = 1.17 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.68 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x...","effect":"oclastogenicity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Red n° 13 (non-oxidative conditions) Absorption through the skin A (mean +2 SD) = 1.17 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.68 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.011 mg/kg bw/d No observed adverse effect level NOAEL = 4.2 mg/kg bw/d (90 day, oral, rat) Margin of Safety NOAEL / SED = 382","page":32,"pdf":"sccs_o_040.pdf","row_type":"noael_study","study_id":"sccs_o_040_noael_010"}
SCCS_vision_codex NOAEL =4.2 mg/kg bw/d rat oral 90 day dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Red n° 13 (non-oxidative conditions) Absorption through the skin A (mean +2 SD) = 1.17 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.68 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x...","effect":"d 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Red n° 13 (non-oxidative conditions) Absorption through the skin A (mean +2 SD) = 1.17 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.68 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.011 mg/kg bw/d No observed adverse effect level NOAEL = 4.2 mg/kg bw/d (90 day, oral, rat) Margin of Safety NOAEL / SED = 382","page":32,"pdf":"sccs_o_040.pdf","row_type":"noael_study","study_id":"sccs_o_040_noael_011"}
SCCS_vision_codex NOAEL =0.01 mg/kg bw/d rat oral 90 day dermal absorption {"dose":"SCCS/1368/10 Opinion on HC Red n° 13 ___________________________________________________________________________________________ 33 (oxidative conditions) Absorption through the skin A (mean +2 SD) = 1.03 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.60 mg Typical body weight of human = 60 kg Systemic...","effect":"SCCS/1368/10 Opinion on HC Red n° 13 ___________________________________________________________________________________________ 33 (oxidative conditions) Absorption through the skin A (mean +2 SD) = 1.03 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.60 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.01 mg/kg bw/d No observed adverse effect level NOAEL = 4.2 mg/kg bw/d (90 day, oral, rat) Margin of Safety NOAEL / SED = 420 3.3.14. Discussion Physico-chemical specifications HC Red n° 13 is used as a hair colouring agent in semi-permanent hair dye formulations at a maximum on-head concentration of 2.5%. It is also used in oxidative hair dye formulations at a maximum concentration of 2.5%, which after mixing typically in 1:1 ratio with hydrogen peroxide prior to use, corresponds to a final on-head concentration of 1.25% upon application. Batch 4/5/6-1 Fas","page":33,"pdf":"sccs_o_040.pdf","row_type":"noael_study","study_id":"sccs_o_040_noael_013"}
SCCS_vision_codex NOAEL =10 - rat - - NOAEL study {"effect":"imals was discoloured. - Organ weights: Absolute and relative organ weight of the spleen was reduced in the females of the test group, whereas the relative spleen weight and the relative weight of the kidney were increased significantly in the corresponding males. - Histopathology: The histomorphological examination revealed a slight activation of the thyroids in 10 male and 1 female rat of the test group. As another substance-related effect lymphatic enteritis was observed in 10 animals of group II Conclusion No NOAEL could be established.","page":21,"pdf":"sccs_o_040.pdf","row_type":"noael_study","study_id":"sccs_o_040_noael_005"}
SCCS_vision_codex NOAEL =5 mg/kg bw/day - - 34 days repeated dose toxicity {"citation":"Ref.: 24 Conclusion of the SCCS on sub-chronic toxicity At 10 mg/kg bw/day significant haematological, histopathological and spleen weight changes were observed","dose":"24 Conclusion of the SCCS on sub-chronic toxicity At 10 mg/kg bw/day significant haematological, histopathological and spleen weight changes were observed.","effect":"SCCS-rejected applicant NOAEL: f the females during the fist week and on isolated occasions up to 34 days after the start of the study. Ref.: 24 Conclusion of the SCCS on sub-chronic toxicity At 10 mg/kg bw/day significant haematological, histopathological and spleen weight changes were observed. The effects seen at 5 mg/kg bw/day (changes in haematological parameters and clinical chemistry, relative kidney weight), are not considered to be adverse (not consistent, not deviating from the normal range, only relative kidney weight changes). The no observed adverse effect level was therefore considered to be 5 mg/kg bw/day of Kardinalrot, corresponding to 4.2 mg/kg bw/day of HC Red n° 13.","page":22,"pdf":"sccs_o_040.pdf","row_type":"noael_study","study_id":"sccs_o_040_noael_006"}
SCCS_vision_codex NOAEL =0.011 mg/kg bw/d rat oral 90 day dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Red n° 13 (non-oxidative conditions) Absorption through the skin A (mean +2 SD) = 1.17 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.68 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x...","effect":"oclastogenicity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Red n° 13 (non-oxidative conditions) Absorption through the skin A (mean +2 SD) = 1.17 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.68 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.011 mg/kg bw/d No observed adverse effect level NOAEL = 4.2 mg/kg bw/d (90 day, oral, rat) Margin of Safety NOAEL / SED = 382","page":32,"pdf":"sccs_o_040.pdf","row_type":"noael_study","study_id":"sccs_o_040_noael_010"}
SCCS_vision_codex NOAEL =4.2 mg/kg bw/d rat oral 90 day dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Red n° 13 (non-oxidative conditions) Absorption through the skin A (mean +2 SD) = 1.17 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.68 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x...","effect":"d 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Red n° 13 (non-oxidative conditions) Absorption through the skin A (mean +2 SD) = 1.17 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.68 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.011 mg/kg bw/d No observed adverse effect level NOAEL = 4.2 mg/kg bw/d (90 day, oral, rat) Margin of Safety NOAEL / SED = 382","page":32,"pdf":"sccs_o_040.pdf","row_type":"noael_study","study_id":"sccs_o_040_noael_011"}
SCCS_vision_codex NOAEL =0.01 mg/kg bw/d rat oral 90 day dermal absorption {"dose":"SCCS/1368/10 Opinion on HC Red n° 13 ___________________________________________________________________________________________ 33 (oxidative conditions) Absorption through the skin A (mean +2 SD) = 1.03 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.60 mg Typical body weight of human = 60 kg Systemic...","effect":"SCCS/1368/10 Opinion on HC Red n° 13 ___________________________________________________________________________________________ 33 (oxidative conditions) Absorption through the skin A (mean +2 SD) = 1.03 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.60 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.01 mg/kg bw/d No observed adverse effect level NOAEL = 4.2 mg/kg bw/d (90 day, oral, rat) Margin of Safety NOAEL / SED = 420 3.3.14. Discussion Physico-chemical specifications HC Red n° 13 is used as a hair colouring agent in semi-permanent hair dye formulations at a maximum on-head concentration of 2.5%. It is also used in oxidative hair dye formulations at a maximum concentration of 2.5%, which after mixing typically in 1:1 ratio with hydrogen peroxide prior to use, corresponds to a final on-head concentration of 1.25% upon application. Batch 4/5/6-1 Fas","page":33,"pdf":"sccs_o_040.pdf","row_type":"noael_study","study_id":"sccs_o_040_noael_013"}
SCCS_vision_codex NOAEL =5 mg/kg bw rat - 90-day dermal absorption {"dose":"In the 90-day studies with rats, 5 mg/kg bw C.P. is considered to be the NOAEL.","effect":"2,2’-[(4-Amino-3- nitrophenyl)imino]-bisethanol hydrochloride was submitted in July 1992 by COLIPA 1, 2. Submission II for HC Red n° 13 was submitted in April 1995 by COLIPA 2. The Scientific Committee on Cosmetology (SCC) adopted at its 62nd plenary meeting on 18 January 1996 an opinion (SCC/106/92) with the final conclusion that: “The irritation tests showed no harmful effects. The substance (C.P. 3) can be classified as non-sensitizer. In the 90-day studies with rats, 5 mg/kg bw C.P. is considered to be the NOAEL. In the teratogenicity study, no signs of maternal or foetal toxicity were observed in the rat after administration of 30 mg/kg bw (NOAEL). It should be noted that the NOAEL stems from a daily exposure for 90 days, whereas human exposure to permanent hair dye is unlikely to be more frequent than once a month. Percutaneous absorption of a formulation was about 0.05.” The substance is currently regulated by the Cosmetics Directive (76/768/EC), Annex III, Part 2 under entry 31 on the list of substances, provisionall","page":5,"pdf":"sccp_o_104.pdf","row_type":"noael_study","study_id":"sccp_o_104_noael_001"}
SCCS_vision_codex NOAEL =30 mg/kg bw rat - 90-day dermal absorption {"dose":"In the 90-day studies with rats, 5 mg/kg bw C.P. is considered to be the NOAEL.","effect":"was submitted in April 1995 by COLIPA 2. The Scientific Committee on Cosmetology (SCC) adopted at its 62nd plenary meeting on 18 January 1996 an opinion (SCC/106/92) with the final conclusion that: “The irritation tests showed no harmful effects. The substance (C.P. 3) can be classified as non-sensitizer. In the 90-day studies with rats, 5 mg/kg bw C.P. is considered to be the NOAEL. In the teratogenicity study, no signs of maternal or foetal toxicity were observed in the rat after administration of 30 mg/kg bw (NOAEL). It should be noted that the NOAEL stems from a daily exposure for 90 days, whereas human exposure to permanent hair dye is unlikely to be more frequent than once a month. Percutaneous absorption of a formulation was about 0.05.” The substance is currently regulated by the Cosmetics Directive (76/768/EC), Annex III, Part 2 under entry 31 on the list of substances, provisionally allowed, which cosmetic products must not contain except subject to restrictions and conditions laid down. Submission III for HC Red n°","page":5,"pdf":"sccp_o_104.pdf","row_type":"noael_study","study_id":"sccp_o_104_noael_002"}
SCCS_vision_codex NOAEL =300 mg/kg/day rat oral 13 weeks NOAEL study {"citation":"Ref.: 22 Study 2 Guideline: OECD 408 (1981) Species/strain: Wistar rats, strain Bor","dose":"howed an activation of thyroid epithelium at doses of 150 and 300 mg/kg/day with increased intensity, accompanied by an enlargement of epithelium cell nuclei at the higher dose.","effect":"howed an activation of thyroid epithelium at doses of 150 and 300 mg/kg/day with increased intensity, accompanied by an enlargement of epithelium cell nuclei at the higher dose. This substance-related effect was restricted to males (4 in group III, 5 in group IV and 4 in group V). Furthermore a liver cell hypertrophy was observed in animals treated with 300 mg/kg/day (8 in group IV and 5 in group V after recovery period). In group V an increase of lipocytes in bone marrows was noted in 5/10 animals. Conclusion No NOAEL could be established. Ref.: 22 Study 2 Guideline: OECD 408 (1981) Species/strain: Wistar rats, strain Bor.Wis.W. (SPF) Group size: 12 animals per sex and group Test substance: Kardinalrot Batch number: / Purity: 82%, 17% water Dose levels: 0, 10 mg/kg bw/day in de-ionised water by gavage Exposure period: 13 weeks GLP: in compliance The test substance (dissolved in water) was administered by oral gavage once daily to a group of 24 Wistar rats (Bor (Wi)W, SPF) (12/sex) at 10 mg/kg/day (group II) for 90 days, 24","page":21,"pdf":"sccp_o_104.pdf","row_type":"noael_study","study_id":"sccp_o_104_noael_004"}
SCCS_vision_codex NOAEL =84 % rat oral 13 weeks NOAEL study {"citation":"Ref.: 23 Study 3 Guideline: OECD 408 (1981) Species/strain: Sprague-Dawley CFY rats Group size: 10 animals per sex and group Test substance: Kardinalrot Batch number: / Purity: 84% (13%","dose":"84% (13% 1-β-hydroxyethylamino-2-nitro-4-bis-(β- hydroxyethyl)amino- benzene and 3% 1-amino-2-nitro-4-(β- hydroxyethyl)aminobenzene Dose levels:","effect":"imals was discoloured. - Organ weights: Absolute and relative organ weight of the spleen was reduced in the females of the test group, whereas the relative spleen weight and the relative weight of the kidney were increased significantly in the corresponding males. - Histopathology: The histomorphological examination revealed a slight activation of the thyroids in 10 male and 1 female rat of the test group. As another substance-related effect lymphatic enteritis was observed in 10 animals of group II Conclusion No NOAEL could be established. Ref.: 23 Study 3 Guideline: OECD 408 (1981) Species/strain: Sprague-Dawley CFY rats Group size: 10 animals per sex and group Test substance: Kardinalrot Batch number: / Purity: 84% (13% 1-β-hydroxyethylamino-2-nitro-4-bis-(β- hydroxyethyl)amino- benzene and 3% 1-amino-2-nitro-4-(β- hydroxyethyl)aminobenzene Dose levels: 0, 5 mg/kg bw/day in de-ionised water by gavage Exposure period: 13 weeks GLP: in compliance The test substance (dissolved in water) was administered by gavage once daily","page":22,"pdf":"sccp_o_104.pdf","row_type":"noael_study","study_id":"sccp_o_104_noael_005"}
SCCS_vision_codex NOAEL =300 mg/kg bw rat oral 90-day reproductive toxicity {"citation":"Ref.: 22)","dose":"hyroid was noted in parental animals of either sex (predominantly in males) in all dose groups.","effect":"hyroid was noted in parental animals of either sex (predominantly in males) in all dose groups. These effects in the parental animals were related to the treatment with the test substance. Conclusion At the highest test dose, clinical signs in terms of discomfort were noted in both males and females. Similar to the findings in the 90-day study an increase in follicular cell hypertrophy in the thyroid was noted (see Ref.: 22). HC Red n° 13 did not reveal any effect on any reproduction parameter. From this study, a NOAEL of 300 mg/kg bw for reproductive effects was deduced. Ref.: 32 3.3.8.2. Teratogenicity Old study, taken from opinion n° XXIV/1287/97 of 20 May 1998 The test substance (dissolved in water) was given daily from day 5-15 of gestation to groups of 24 pregnant Wistar rats, respectively, (Bor:Wisw-SPF TNO strain) by oral gavage of doses of 5 (group I), 15 (group II) and 30 (group III) mg/kg bw. 24 pregnant females treated with aqua deionised served as controls. Prior to treatment females were 14 weeks old and had a b","page":30,"pdf":"sccp_o_104.pdf","row_type":"noael_study","study_id":"sccp_o_104_noael_006"}
SCCS_vision_codex NOAEL =30 mg/kg rat oral - NOAEL study {"dose":"Thus the NOAEL is 30 mg/kg.","effect":"foetuses, distribution and site in the uterus, early and late resorptions, placentas, implantations, sex determination, corpora lutea. - Determination of the weight of foetuses, placentas, graved uteri, uteri without foetuses. - Externally visible deviations in foetuses, organic imperfections (in 1/3 of all foetuses) and skeletal defects (in 2/3 of all foetuses) were evaluated. Results No maternal abnormalities and no signs of maternal toxicity were observed. No abnormalities were found in the foetuses. Thus the NOAEL is 30 mg/kg. New study Guideline: OECD 414 (1984) Species/strain: HanBri: WIST (SPF quality) rats Group size: 22 mated females per dose group Test substance: HC Red No. 13 (WR 23020) in bi-distilled water Batch number: 4/5/6-1 Fass 3 (Fa. Robinson) Purity: 98.4 % (HPLC at 254 nm) Dose levels: 0, 30, 100 and 300 mg /kg/day (oral, gavage) Treatment period: once daily, day 6 - 20 of gestation GLP: In compliance","page":30,"pdf":"sccp_o_104.pdf","row_type":"noael_study","study_id":"sccp_o_104_noael_007"}
SCCS_vision_codex NOAEL =4.2 mg/kg bw/day rat dermal 90-day reproductive toxicity {"dose":"General toxicity LD50 was calculated to be 2120 (1810 - 2480) mg/kg bw.","effect":"0 ppb. No documentation was provided to support the data presented in the table \"Batch comparison\" The stability of the test substance in marketed products was not reported. General toxicity LD50 was calculated to be 2120 (1810 - 2480) mg/kg bw. Based on the effects seen in the 90-day study (changes in haematological parameters and clinical chemistry, relative kidney weight), the Lowest Observed Effect Level was considered to be 5 mg/kg bw/day of Kardinalrot, corresponding to 4.2 mg/kg bw/day of HC Red n° 13. The NOAEL for reproductive effects was set at 300 mg/kg bw/day. A NOAEL of 300 mg/kg bw/day for both materno-toxic and for embryo-foetal effects was deduced. Toxicokinetics In vitro, HC Red n° 13 revealed a Papp of 37.1 x 10-6 cm/sec and thus was classified to be of high permeability. The observed value indicates a good absorption from the gastro- intestinal tract. After dermal application in rats, only minor amounts of HC Red n° 13 are absorbed through the skin and become systemically available. If applied in a hair dye","page":33,"pdf":"sccp_o_104.pdf","row_type":"noael_study","study_id":"sccp_o_104_noael_009"}
SCCS_vision_codex NOAEL =300 mg/kg bw/day rat dermal 90-day reproductive toxicity {"dose":"General toxicity LD50 was calculated to be 2120 (1810 - 2480) mg/kg bw.","effect":"nted in the table \"Batch comparison\" The stability of the test substance in marketed products was not reported. General toxicity LD50 was calculated to be 2120 (1810 - 2480) mg/kg bw. Based on the effects seen in the 90-day study (changes in haematological parameters and clinical chemistry, relative kidney weight), the Lowest Observed Effect Level was considered to be 5 mg/kg bw/day of Kardinalrot, corresponding to 4.2 mg/kg bw/day of HC Red n° 13. The NOAEL for reproductive effects was set at 300 mg/kg bw/day. A NOAEL of 300 mg/kg bw/day for both materno-toxic and for embryo-foetal effects was deduced. Toxicokinetics In vitro, HC Red n° 13 revealed a Papp of 37.1 x 10-6 cm/sec and thus was classified to be of high permeability. The observed value indicates a good absorption from the gastro- intestinal tract. After dermal application in rats, only minor amounts of HC Red n° 13 are absorbed through the skin and become systemically available. If applied in a hair dye formulation as vehicle less than 1.1 µg/cm2 of the dye formula","page":33,"pdf":"sccp_o_104.pdf","row_type":"noael_study","study_id":"sccp_o_104_noael_010"}
SCCS_vision_codex NOAEL =10 - rat - - NOAEL study {"effect":"imals was discoloured. - Organ weights: Absolute and relative organ weight of the spleen was reduced in the females of the test group, whereas the relative spleen weight and the relative weight of the kidney were increased significantly in the corresponding males. - Histopathology: The histomorphological examination revealed a slight activation of the thyroids in 10 male and 1 female rat of the test group. As another substance-related effect lymphatic enteritis was observed in 10 animals of group II Conclusion No NOAEL could be established.","page":21,"pdf":"sccs_o_040.pdf","row_type":"noael_study","study_id":"sccs_o_040_noael_005"}
SCCS_vision_codex NOAEL =5 mg/kg bw/day - - 34 days repeated dose toxicity {"citation":"Ref.: 24 Conclusion of the SCCS on sub-chronic toxicity At 10 mg/kg bw/day significant haematological, histopathological and spleen weight changes were observed","dose":"24 Conclusion of the SCCS on sub-chronic toxicity At 10 mg/kg bw/day significant haematological, histopathological and spleen weight changes were observed.","effect":"SCCS-rejected applicant NOAEL: f the females during the fist week and on isolated occasions up to 34 days after the start of the study. Ref.: 24 Conclusion of the SCCS on sub-chronic toxicity At 10 mg/kg bw/day significant haematological, histopathological and spleen weight changes were observed. The effects seen at 5 mg/kg bw/day (changes in haematological parameters and clinical chemistry, relative kidney weight), are not considered to be adverse (not consistent, not deviating from the normal range, only relative kidney weight changes). The no observed adverse effect level was therefore considered to be 5 mg/kg bw/day of Kardinalrot, corresponding to 4.2 mg/kg bw/day of HC Red n° 13.","page":22,"pdf":"sccs_o_040.pdf","row_type":"noael_study","study_id":"sccs_o_040_noael_006"}
SCCS_vision_codex NOAEL =0.011 mg/kg bw/d rat oral 90 day dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Red n° 13 (non-oxidative conditions) Absorption through the skin A (mean +2 SD) = 1.17 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.68 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x...","effect":"oclastogenicity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Red n° 13 (non-oxidative conditions) Absorption through the skin A (mean +2 SD) = 1.17 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.68 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.011 mg/kg bw/d No observed adverse effect level NOAEL = 4.2 mg/kg bw/d (90 day, oral, rat) Margin of Safety NOAEL / SED = 382","page":32,"pdf":"sccs_o_040.pdf","row_type":"noael_study","study_id":"sccs_o_040_noael_010"}
SCCS_vision_codex NOAEL =4.2 mg/kg bw/d rat oral 90 day dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Red n° 13 (non-oxidative conditions) Absorption through the skin A (mean +2 SD) = 1.17 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.68 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x...","effect":"d 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Red n° 13 (non-oxidative conditions) Absorption through the skin A (mean +2 SD) = 1.17 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.68 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.011 mg/kg bw/d No observed adverse effect level NOAEL = 4.2 mg/kg bw/d (90 day, oral, rat) Margin of Safety NOAEL / SED = 382","page":32,"pdf":"sccs_o_040.pdf","row_type":"noael_study","study_id":"sccs_o_040_noael_011"}
SCCS_vision_codex NOAEL =0.01 mg/kg bw/d rat oral 90 day dermal absorption {"dose":"SCCS/1368/10 Opinion on HC Red n° 13 ___________________________________________________________________________________________ 33 (oxidative conditions) Absorption through the skin A (mean +2 SD) = 1.03 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.60 mg Typical body weight of human = 60 kg Systemic...","effect":"SCCS/1368/10 Opinion on HC Red n° 13 ___________________________________________________________________________________________ 33 (oxidative conditions) Absorption through the skin A (mean +2 SD) = 1.03 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.60 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.01 mg/kg bw/d No observed adverse effect level NOAEL = 4.2 mg/kg bw/d (90 day, oral, rat) Margin of Safety NOAEL / SED = 420 3.3.14. Discussion Physico-chemical specifications HC Red n° 13 is used as a hair colouring agent in semi-permanent hair dye formulations at a maximum on-head concentration of 2.5%. It is also used in oxidative hair dye formulations at a maximum concentration of 2.5%, which after mixing typically in 1:1 ratio with hydrogen peroxide prior to use, corresponds to a final on-head concentration of 1.25% upon application. Batch 4/5/6-1 Fas","page":33,"pdf":"sccs_o_040.pdf","row_type":"noael_study","study_id":"sccs_o_040_noael_013"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies 27 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 300 mg/kg/day rat oral 13 weeks - SOURCE_SUBDIR=sccp_o_104; REPORT_TITLE=OPINION ON HC Red n° 13 COLIPA n° B31; OPINION_NUMBER=SCCP/1075/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=19 June 2007; VALUE_TEXT=300; DOSE=howed an activation of thyroid epithelium at doses of 150 and 300 mg/kg/day with increased intensity, accompanied by an enlargement of epithelium cell nuclei at the higher dose.; EFFECT=howed an activation of thyroid epithelium at doses of 150 and 300 mg/kg/day with increased intensity, accompanied by an enlargement of epithelium cell nuclei at the higher dose. This substance-related effect was restricted to males (4 in group III, 5 in group IV and 4 in group V). Furthermore a liver cell hypertrophy was observed in animals treated with 300 mg/kg/day (8 in group IV and 5 in group V after recovery period). In group V an increase of lipocytes in bone marrows was noted in 5/10 animals. Conclusion No NOAEL could be established. Ref.: 22 Study 2 Guideline: OECD 408 (1981) Species/strain: Wistar rats, strain Bor.Wis.W. (SPF) Group size: 12 animals per sex and group Test substance: Kardinalrot Batch number: / Purity: 82%, 17% water Dose levels: 0, 10 mg/kg bw/day in de-ionised water by gavage Exposure period: 13 weeks GLP: in compliance The test substance (dissolved in water) was administered by oral gavage once daily to a group of 24 Wistar rats (Bor (Wi)W, SPF) (12/sex) at 10 mg/kg/day (group II) for 90 days, 24; CITATION=Ref.: 22 Study 2 Guideline: OECD 408 (1981) Species/strain: Wistar rats, strain Bor; CITATION_NUMBERS=[22,2,408,1981]; REFERENCE=Ref.: 22 Study 2 Guideline: OECD 408 (1981) Species/strain: Wistar rats, strain Bor; DETAILS_JSON={"cas_number":"29705-39-3","citation":"Ref.: 22 Study 2 Guideline: OECD 408 (1981) Species/strain: Wistar rats, strain Bor","dose":"howed an activation of thyroid epithelium at doses of 150 and 300 mg/kg/day with increased intensity, accompanied by an enlargement of epithelium cell nuclei at the higher dose.","duration":"13 weeks","effect":"howed an activation of thyroid epithelium at doses of 150 and 300 mg/kg/day with increased intensity, accompanied by an enlargement of epithelium cell nuclei at the higher dose. This substance-related effect was restricted to males (4 in group III, 5 in group IV and 4 in group V). Furthermore a liver cell hypertrophy was observed in animals treated with 300 mg/kg/day (8 in group IV and 5 in group V after recovery period). In group V an increase of lipocytes in bone marrows was noted in 5/10 animals. Conclusion No NOAEL could be established. Ref.: 22 Study 2 Guideline: OECD 408 (1981) Species/strain: Wistar rats, strain Bor.Wis.W. (SPF) Group size: 12 animals per sex and group Test substance: Kardinalrot Batch number: / Purity: 82%, 17% water Dose levels: 0, 10 mg/kg bw/day in de-ionised water by gavage Exposure period: 13 weeks GLP: in compliance The test substance (dissolved in water) was administered by oral gavage once daily to a group of 24 Wistar rats (Bor (Wi)W, SPF) (12/sex) at 10 mg/kg/day (group II) for 90 days, 24","endpoint":"","ingredient":"HC Red No. 13","loael_value":"","noael_unit":"mg/kg/day","noael_value":"300","page":21,"route":"oral","species":"rat","study_id":"sccp_o_104_noael_004"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 84 % rat oral 13 weeks - SOURCE_SUBDIR=sccp_o_104; REPORT_TITLE=OPINION ON HC Red n° 13 COLIPA n° B31; OPINION_NUMBER=SCCP/1075/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=19 June 2007; VALUE_TEXT=84; DOSE=84% (13% 1-β-hydroxyethylamino-2-nitro-4-bis-(β- hydroxyethyl)amino- benzene and 3% 1-amino-2-nitro-4-(β- hydroxyethyl)aminobenzene Dose levels:; EFFECT=imals was discoloured. - Organ weights: Absolute and relative organ weight of the spleen was reduced in the females of the test group, whereas the relative spleen weight and the relative weight of the kidney were increased significantly in the corresponding males. - Histopathology: The histomorphological examination revealed a slight activation of the thyroids in 10 male and 1 female rat of the test group. As another substance-related effect lymphatic enteritis was observed in 10 animals of group II Conclusion No NOAEL could be established. Ref.: 23 Study 3 Guideline: OECD 408 (1981) Species/strain: Sprague-Dawley CFY rats Group size: 10 animals per sex and group Test substance: Kardinalrot Batch number: / Purity: 84% (13% 1-β-hydroxyethylamino-2-nitro-4-bis-(β- hydroxyethyl)amino- benzene and 3% 1-amino-2-nitro-4-(β- hydroxyethyl)aminobenzene Dose levels: 0, 5 mg/kg bw/day in de-ionised water by gavage Exposure period: 13 weeks GLP: in compliance The test substance (dissolved in water) was administered by gavage once daily; CITATION=Ref.: 23 Study 3 Guideline: OECD 408 (1981) Species/strain: Sprague-Dawley CFY rats Group size: 10 animals per sex and group Test substance: Kardinalrot Batch number: / Purity: 84% (13%; CITATION_NUMBERS=[23,3,408,1981,10,84,13]; REFERENCE=Ref.: 23 Study 3 Guideline: OECD 408 (1981) Species/strain: Sprague-Dawley CFY rats Group size: 10 animals per sex and group Test substance: Kardinalrot Batch number: / Purity: 84% (13%; DETAILS_JSON={"cas_number":"29705-39-3","citation":"Ref.: 23 Study 3 Guideline: OECD 408 (1981) Species/strain: Sprague-Dawley CFY rats Group size: 10 animals per sex and group Test substance: Kardinalrot Batch number: / Purity: 84% (13%","dose":"84% (13% 1-β-hydroxyethylamino-2-nitro-4-bis-(β- hydroxyethyl)amino- benzene and 3% 1-amino-2-nitro-4-(β- hydroxyethyl)aminobenzene Dose levels:","duration":"13 weeks","effect":"imals was discoloured. - Organ weights: Absolute and relative organ weight of the spleen was reduced in the females of the test group, whereas the relative spleen weight and the relative weight of the kidney were increased significantly in the corresponding males. - Histopathology: The histomorphological examination revealed a slight activation of the thyroids in 10 male and 1 female rat of the test group. As another substance-related effect lymphatic enteritis was observed in 10 animals of group II Conclusion No NOAEL could be established. Ref.: 23 Study 3 Guideline: OECD 408 (1981) Species/strain: Sprague-Dawley CFY rats Group size: 10 animals per sex and group Test substance: Kardinalrot Batch number: / Purity: 84% (13% 1-β-hydroxyethylamino-2-nitro-4-bis-(β- hydroxyethyl)amino- benzene and 3% 1-amino-2-nitro-4-(β- hydroxyethyl)aminobenzene Dose levels: 0, 5 mg/kg bw/day in de-ionised water by gavage Exposure period: 13 weeks GLP: in compliance The test substance (dissolved in water) was administered by gavage once daily","endpoint":"","ingredient":"HC Red No. 13","loael_value":"","noael_unit":"%","noael_value":"84","page":22,"route":"oral","species":"rat","study_id":"sccp_o_104_noael_005"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 30 mg/kg rat oral - - SOURCE_SUBDIR=sccp_o_104; REPORT_TITLE=OPINION ON HC Red n° 13 COLIPA n° B31; OPINION_NUMBER=SCCP/1075/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=19 June 2007; VALUE_TEXT=30; DOSE=Thus the NOAEL is 30 mg/kg.; EFFECT=foetuses, distribution and site in the uterus, early and late resorptions, placentas, implantations, sex determination, corpora lutea. - Determination of the weight of foetuses, placentas, graved uteri, uteri without foetuses. - Externally visible deviations in foetuses, organic imperfections (in 1/3 of all foetuses) and skeletal defects (in 2/3 of all foetuses) were evaluated. Results No maternal abnormalities and no signs of maternal toxicity were observed. No abnormalities were found in the foetuses. Thus the NOAEL is 30 mg/kg. New study Guideline: OECD 414 (1984) Species/strain: HanBri: WIST (SPF quality) rats Group size: 22 mated females per dose group Test substance: HC Red No. 13 (WR 23020) in bi-distilled water Batch number: 4/5/6-1 Fass 3 (Fa. Robinson) Purity: 98.4 % (HPLC at 254 nm) Dose levels: 0, 30, 100 and 300 mg /kg/day (oral, gavage) Treatment period: once daily, day 6 - 20 of gestation GLP: In compliance; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"29705-39-3","citation":"","dose":"Thus the NOAEL is 30 mg/kg.","duration":"","effect":"foetuses, distribution and site in the uterus, early and late resorptions, placentas, implantations, sex determination, corpora lutea. - Determination of the weight of foetuses, placentas, graved uteri, uteri without foetuses. - Externally visible deviations in foetuses, organic imperfections (in 1/3 of all foetuses) and skeletal defects (in 2/3 of all foetuses) were evaluated. Results No maternal abnormalities and no signs of maternal toxicity were observed. No abnormalities were found in the foetuses. Thus the NOAEL is 30 mg/kg. New study Guideline: OECD 414 (1984) Species/strain: HanBri: WIST (SPF quality) rats Group size: 22 mated females per dose group Test substance: HC Red No. 13 (WR 23020) in bi-distilled water Batch number: 4/5/6-1 Fass 3 (Fa. Robinson) Purity: 98.4 % (HPLC at 254 nm) Dose levels: 0, 30, 100 and 300 mg /kg/day (oral, gavage) Treatment period: once daily, day 6 - 20 of gestation GLP: In compliance","endpoint":"","ingredient":"HC Red No. 13","loael_value":"","noael_unit":"mg/kg","noael_value":"30","page":30,"route":"oral","species":"rat","study_id":"sccp_o_104_noael_007"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 300 mg/kg bw rat - - - SOURCE_SUBDIR=sccp_o_104; REPORT_TITLE=OPINION ON HC Red n° 13 COLIPA n° B31; OPINION_NUMBER=SCCP/1075/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=19 June 2007; VALUE_TEXT=300; DOSE=ence nor a dose-dependent increase in any type of malformation was noted.; EFFECT=ence nor a dose-dependent increase in any type of malformation was noted. Further, there were no changes in variations which were regarded to be related to the treatment with HC Red No. 13. All observed variations represented common findings for the used rat strain and were within the spontaneous range for variations and/or revealed no dose-response relationship. Conclusion No treatment-related effects were noted in dams and foetuses in a rat teratogenicity study up to the highest test dose of 300 mg/kg bw/day. A NOAEL of 300 mg/kg bw for both maternotoxic and for embryo-foetal effects was deduced. Ref.: 33 3.3.9. Toxicokinetics 3.3.9.1. Toxicokinetics in vitro Biovailability study with human intestinal epithelial cells Guideline: / Cells: Human intestinal epithelial cell line TC-7 Test substance: HC Red No. 13 Batch: 4/5/6-1 Fass 3 Purity: 98.4 % (HPLC at 254 nm) Concentration: ≤ 50 µM in HBSS buffer containing 1 % DMSO Incubation time: 60 min Number of experiments: Two independent experiments GLP: / The bioavailability of; CITATION=Ref.: 33 3; CITATION_NUMBERS=[33,3]; REFERENCE=Ref.: 33 3; DETAILS_JSON={"cas_number":"29705-39-3","citation":"Ref.: 33 3","dose":"ence nor a dose-dependent increase in any type of malformation was noted.","duration":"","effect":"ence nor a dose-dependent increase in any type of malformation was noted. Further, there were no changes in variations which were regarded to be related to the treatment with HC Red No. 13. All observed variations represented common findings for the used rat strain and were within the spontaneous range for variations and/or revealed no dose-response relationship. Conclusion No treatment-related effects were noted in dams and foetuses in a rat teratogenicity study up to the highest test dose of 300 mg/kg bw/day. A NOAEL of 300 mg/kg bw for both maternotoxic and for embryo-foetal effects was deduced. Ref.: 33 3.3.9. Toxicokinetics 3.3.9.1. Toxicokinetics in vitro Biovailability study with human intestinal epithelial cells Guideline: / Cells: Human intestinal epithelial cell line TC-7 Test substance: HC Red No. 13 Batch: 4/5/6-1 Fass 3 Purity: 98.4 % (HPLC at 254 nm) Concentration: ≤ 50 µM in HBSS buffer containing 1 % DMSO Incubation time: 60 min Number of experiments: Two independent experiments GLP: / The bioavailability of","endpoint":"","ingredient":"HC Red No. 13","loael_value":"","noael_unit":"mg/kg bw","noael_value":"300","page":31,"route":"","species":"rat","study_id":"sccp_o_104_noael_008"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 300 mg/kg bw/day rat oral 13 weeks - SOURCE_SUBDIR=sccs_o_040; REPORT_TITLE=OPINION ON HC Red n° 13 COLIPA n° B31; OPINION_NUMBER=SCCS/1368/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 17 June 2007; VALUE_TEXT=300; DOSE=an activation of thyroid epithelium at doses of 150 and 300 mg/kg bw/day with increased intensity, accompanied by an enlargement of epithelium cell nuclei at the higher dose.; EFFECT=an activation of thyroid epithelium at doses of 150 and 300 mg/kg bw/day with increased intensity, accompanied by an enlargement of epithelium cell nuclei at the higher dose. This substance-related effect was restricted to males (4 in group III, 5 in group IV and 4 in group V). Furthermore a liver cell hypertrophy was observed in animals treated with 300 mg/kg bw/day (8 in group IV and 5 in group V after recovery period). In group V an increase of lipocytes in bone marrows was noted in 5/10 animals. Conclusion No NOAEL could be established. Ref.: 22 Study 2 Guideline: OECD 408 (1981) Species/strain: Wistar rats, strain Bor.Wis.W. (SPF) Group size: 12 animals per sex and group Test substance: Kardinalrot Batch number: / Purity: 82%, 17% water Dose levels: 0, 10 mg/kg bw/day in de-ionised water by gavage Exposure period: 13 weeks GLP: in compliance The test substance (dissolved in water) was administered by oral gavage once daily to a group of 24 Wistar rats (Bor (Wi)W, SPF) (12/sex) at 10 mg/kg bw/day (group II) for 90 days,; CITATION=Ref.: 22 Study 2 Guideline: OECD 408 (1981) Species/strain: Wistar rats, strain Bor; CITATION_NUMBERS=[22,2,408,1981]; REFERENCE=Ref.: 22 Study 2 Guideline: OECD 408 (1981) Species/strain: Wistar rats, strain Bor; DETAILS_JSON={"cas_number":"29705-39-3","citation":"Ref.: 22 Study 2 Guideline: OECD 408 (1981) Species/strain: Wistar rats, strain Bor","dose":"an activation of thyroid epithelium at doses of 150 and 300 mg/kg bw/day with increased intensity, accompanied by an enlargement of epithelium cell nuclei at the higher dose.","duration":"13 weeks","effect":"an activation of thyroid epithelium at doses of 150 and 300 mg/kg bw/day with increased intensity, accompanied by an enlargement of epithelium cell nuclei at the higher dose. This substance-related effect was restricted to males (4 in group III, 5 in group IV and 4 in group V). Furthermore a liver cell hypertrophy was observed in animals treated with 300 mg/kg bw/day (8 in group IV and 5 in group V after recovery period). In group V an increase of lipocytes in bone marrows was noted in 5/10 animals. Conclusion No NOAEL could be established. Ref.: 22 Study 2 Guideline: OECD 408 (1981) Species/strain: Wistar rats, strain Bor.Wis.W. (SPF) Group size: 12 animals per sex and group Test substance: Kardinalrot Batch number: / Purity: 82%, 17% water Dose levels: 0, 10 mg/kg bw/day in de-ionised water by gavage Exposure period: 13 weeks GLP: in compliance The test substance (dissolved in water) was administered by oral gavage once daily to a group of 24 Wistar rats (Bor (Wi)W, SPF) (12/sex) at 10 mg/kg bw/day (group II) for 90 days,","endpoint":"","ingredient":"HC Red No. 13","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"300","page":21,"route":"oral","species":"rat","study_id":"sccs_o_040_noael_004"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 10 - rat - - - SOURCE_SUBDIR=sccs_o_040; REPORT_TITLE=OPINION ON HC Red n° 13 COLIPA n° B31; OPINION_NUMBER=SCCS/1368/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 17 June 2007; VALUE_TEXT=unclear:imals was discoloured. - Organ weights: Absolute and relative organ weight of the spleen was reduced in the females of the test group, whereas the relative spleen weight and the relative weight of the kidney were increased significantly in the corresponding males. - Histopathology: The histomorphological examination revealed a slight activation of the thyroids in 10 male and 1 female rat of the test group. As another substance-related effect lymphatic enteritis was observed in 10 animals of group II Conclusion No NOAEL could be established.; EFFECT=imals was discoloured. - Organ weights: Absolute and relative organ weight of the spleen was reduced in the females of the test group, whereas the relative spleen weight and the relative weight of the kidney were increased significantly in the corresponding males. - Histopathology: The histomorphological examination revealed a slight activation of the thyroids in 10 male and 1 female rat of the test group. As another substance-related effect lymphatic enteritis was observed in 10 animals of group II Conclusion No NOAEL could be established.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"29705-39-3","citation":"","dose":"","duration":"","effect":"imals was discoloured. - Organ weights: Absolute and relative organ weight of the spleen was reduced in the females of the test group, whereas the relative spleen weight and the relative weight of the kidney were increased significantly in the corresponding males. - Histopathology: The histomorphological examination revealed a slight activation of the thyroids in 10 male and 1 female rat of the test group. As another substance-related effect lymphatic enteritis was observed in 10 animals of group II Conclusion No NOAEL could be established.","endpoint":"","ingredient":"HC Red No. 13","loael_value":"","noael_unit":"","noael_value":"unclear:imals was discoloured. - Organ weights: Absolute and relative organ weight of the spleen was reduced in the females of the test group, whereas the relative spleen weight and the relative weight of the kidney were increased significantly in the corresponding males. - Histopathology: The histomorphological examination revealed a slight activation of the thyroids in 10 male and 1 female rat of the test group. As another substance-related effect lymphatic enteritis was observed in 10 animals of group II Conclusion No NOAEL could be established.","page":21,"route":"","species":"rat","study_id":"sccs_o_040_noael_005"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 30 mg/kg bw/day rat oral - - SOURCE_SUBDIR=sccs_o_040; REPORT_TITLE=OPINION ON HC Red n° 13 COLIPA n° B31; OPINION_NUMBER=SCCS/1368/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 17 June 2007; VALUE_TEXT=30; DOSE=Thus the NOAEL is 30 mg/kg bw/day.; EFFECT=foetuses, distribution and site in the uterus, early and late resorptions, placentas, implantations, sex determination, corpora lutea. - Determination of the weight of foetuses, placentas, graved uteri, uteri without foetuses. - Externally visible deviations in foetuses, organic imperfections (in 1/3 of all foetuses) and skeletal defects (in 2/3 of all foetuses) were evaluated. Results No maternal abnormalities and no signs of maternal toxicity were observed. No abnormalities were found in the foetuses. Thus the NOAEL is 30 mg/kg bw/day. New study Guideline: OECD 414 (1984) Species/strain: HanBri: WIST (SPF quality) rats Group size: 22 mated females per dose group Test substance: HC Red n° 13 (WR 23020) in bi-distilled water Batch number: 4/5/6-1 Fass 3 (Fa. Robinson) Purity: 98.4 % (HPLC at 254 nm) Dose levels: 0, 30, 100 and 300 mg /kg bw/day (oral, gavage) Treatment period: once daily, day 6 - 20 of gestation GLP: In compliance The test substance was administered in a constant volume of 10 ml/kg bw once daily by oral gav; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"29705-39-3","citation":"","dose":"Thus the NOAEL is 30 mg/kg bw/day.","duration":"","effect":"foetuses, distribution and site in the uterus, early and late resorptions, placentas, implantations, sex determination, corpora lutea. - Determination of the weight of foetuses, placentas, graved uteri, uteri without foetuses. - Externally visible deviations in foetuses, organic imperfections (in 1/3 of all foetuses) and skeletal defects (in 2/3 of all foetuses) were evaluated. Results No maternal abnormalities and no signs of maternal toxicity were observed. No abnormalities were found in the foetuses. Thus the NOAEL is 30 mg/kg bw/day. New study Guideline: OECD 414 (1984) Species/strain: HanBri: WIST (SPF quality) rats Group size: 22 mated females per dose group Test substance: HC Red n° 13 (WR 23020) in bi-distilled water Batch number: 4/5/6-1 Fass 3 (Fa. Robinson) Purity: 98.4 % (HPLC at 254 nm) Dose levels: 0, 30, 100 and 300 mg /kg bw/day (oral, gavage) Treatment period: once daily, day 6 - 20 of gestation GLP: In compliance The test substance was administered in a constant volume of 10 ml/kg bw once daily by oral gav","endpoint":"","ingredient":"HC Red No. 13","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"30","page":30,"route":"oral","species":"rat","study_id":"sccs_o_040_noael_008"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 300 mg/kg bw/day rat - - - SOURCE_SUBDIR=sccs_o_040; REPORT_TITLE=OPINION ON HC Red n° 13 COLIPA n° B31; OPINION_NUMBER=SCCS/1368/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 17 June 2007; VALUE_TEXT=300; DOSE=rence nor a dose-dependent increase in any type of malformation was noted.; EFFECT=rence nor a dose-dependent increase in any type of malformation was noted. Further, there were no changes in variations which were regarded to be related to the treatment with HC Red n° 13. All observed variations represented common findings for the used rat strain and were within the spontaneous range for variations and/or revealed no dose-response relationship. Conclusion No treatment-related effects were noted in dams and foetuses in a rat teratogenicity study up to the highest test dose of 300 mg/kg bw/day. A NOAEL of 300 mg/kg bw/d for both maternal toxicity and for embryo-foetal effects was deduced. Ref.: 33 3.3.9. Toxicokinetics 3.3.9.1. Toxicokinetics in vitro Biovailability study with human intestinal epithelial cells Guideline: / Cells: Human intestinal epithelial cell line TC-7 Test substance: HC Red n° 13 Batch: 4/5/6-1 Fass 3 Purity: 98.4 % (HPLC at 254 nm) Concentration: ≤ 50 µM in HBSS buffer containing 1 % DMSO Incubation time: 60 min Number of experiments: Two independent experiments GLP: / The bioavailabil; CITATION=Ref.: 33 3; CITATION_NUMBERS=[33,3]; REFERENCE=Ref.: 33 3; DETAILS_JSON={"cas_number":"29705-39-3","citation":"Ref.: 33 3","dose":"rence nor a dose-dependent increase in any type of malformation was noted.","duration":"","effect":"rence nor a dose-dependent increase in any type of malformation was noted. Further, there were no changes in variations which were regarded to be related to the treatment with HC Red n° 13. All observed variations represented common findings for the used rat strain and were within the spontaneous range for variations and/or revealed no dose-response relationship. Conclusion No treatment-related effects were noted in dams and foetuses in a rat teratogenicity study up to the highest test dose of 300 mg/kg bw/day. A NOAEL of 300 mg/kg bw/d for both maternal toxicity and for embryo-foetal effects was deduced. Ref.: 33 3.3.9. Toxicokinetics 3.3.9.1. Toxicokinetics in vitro Biovailability study with human intestinal epithelial cells Guideline: / Cells: Human intestinal epithelial cell line TC-7 Test substance: HC Red n° 13 Batch: 4/5/6-1 Fass 3 Purity: 98.4 % (HPLC at 254 nm) Concentration: ≤ 50 µM in HBSS buffer containing 1 % DMSO Incubation time: 60 min Number of experiments: Two independent experiments GLP: / The bioavailabil","endpoint":"","ingredient":"HC Red No. 13","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"300","page":31,"route":"","species":"rat","study_id":"sccs_o_040_noael_009"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption 5 mg/kg bw rat - 90-day dermal absorption SOURCE_SUBDIR=sccp_o_104; REPORT_TITLE=OPINION ON HC Red n° 13 COLIPA n° B31; OPINION_NUMBER=SCCP/1075/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=19 June 2007; VALUE_TEXT=5; DOSE=In the 90-day studies with rats, 5 mg/kg bw C.P. is considered to be the NOAEL.; EFFECT=2,2’-[(4-Amino-3- nitrophenyl)imino]-bisethanol hydrochloride was submitted in July 1992 by COLIPA 1, 2. Submission II for HC Red n° 13 was submitted in April 1995 by COLIPA 2. The Scientific Committee on Cosmetology (SCC) adopted at its 62nd plenary meeting on 18 January 1996 an opinion (SCC/106/92) with the final conclusion that: “The irritation tests showed no harmful effects. The substance (C.P. 3) can be classified as non-sensitizer. In the 90-day studies with rats, 5 mg/kg bw C.P. is considered to be the NOAEL. In the teratogenicity study, no signs of maternal or foetal toxicity were observed in the rat after administration of 30 mg/kg bw (NOAEL). It should be noted that the NOAEL stems from a daily exposure for 90 days, whereas human exposure to permanent hair dye is unlikely to be more frequent than once a month. Percutaneous absorption of a formulation was about 0.05.” The substance is currently regulated by the Cosmetics Directive (76/768/EC), Annex III, Part 2 under entry 31 on the list of substances, provisionall; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"29705-39-3","citation":"","dose":"In the 90-day studies with rats, 5 mg/kg bw C.P. is considered to be the NOAEL.","duration":"90-day","effect":"2,2’-[(4-Amino-3- nitrophenyl)imino]-bisethanol hydrochloride was submitted in July 1992 by COLIPA 1, 2. Submission II for HC Red n° 13 was submitted in April 1995 by COLIPA 2. The Scientific Committee on Cosmetology (SCC) adopted at its 62nd plenary meeting on 18 January 1996 an opinion (SCC/106/92) with the final conclusion that: “The irritation tests showed no harmful effects. The substance (C.P. 3) can be classified as non-sensitizer. In the 90-day studies with rats, 5 mg/kg bw C.P. is considered to be the NOAEL. In the teratogenicity study, no signs of maternal or foetal toxicity were observed in the rat after administration of 30 mg/kg bw (NOAEL). It should be noted that the NOAEL stems from a daily exposure for 90 days, whereas human exposure to permanent hair dye is unlikely to be more frequent than once a month. Percutaneous absorption of a formulation was about 0.05.” The substance is currently regulated by the Cosmetics Directive (76/768/EC), Annex III, Part 2 under entry 31 on the list of substances, provisionall","endpoint":"dermal absorption","ingredient":"HC Red No. 13","loael_value":"","noael_unit":"mg/kg bw","noael_value":"5","page":5,"route":"","species":"rat","study_id":"sccp_o_104_noael_001"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption 30 mg/kg bw rat - 90-day dermal absorption SOURCE_SUBDIR=sccp_o_104; REPORT_TITLE=OPINION ON HC Red n° 13 COLIPA n° B31; OPINION_NUMBER=SCCP/1075/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=19 June 2007; VALUE_TEXT=30; DOSE=In the 90-day studies with rats, 5 mg/kg bw C.P. is considered to be the NOAEL.; EFFECT=was submitted in April 1995 by COLIPA 2. The Scientific Committee on Cosmetology (SCC) adopted at its 62nd plenary meeting on 18 January 1996 an opinion (SCC/106/92) with the final conclusion that: “The irritation tests showed no harmful effects. The substance (C.P. 3) can be classified as non-sensitizer. In the 90-day studies with rats, 5 mg/kg bw C.P. is considered to be the NOAEL. In the teratogenicity study, no signs of maternal or foetal toxicity were observed in the rat after administration of 30 mg/kg bw (NOAEL). It should be noted that the NOAEL stems from a daily exposure for 90 days, whereas human exposure to permanent hair dye is unlikely to be more frequent than once a month. Percutaneous absorption of a formulation was about 0.05.” The substance is currently regulated by the Cosmetics Directive (76/768/EC), Annex III, Part 2 under entry 31 on the list of substances, provisionally allowed, which cosmetic products must not contain except subject to restrictions and conditions laid down. Submission III for HC Red n°; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"29705-39-3","citation":"","dose":"In the 90-day studies with rats, 5 mg/kg bw C.P. is considered to be the NOAEL.","duration":"90-day","effect":"was submitted in April 1995 by COLIPA 2. The Scientific Committee on Cosmetology (SCC) adopted at its 62nd plenary meeting on 18 January 1996 an opinion (SCC/106/92) with the final conclusion that: “The irritation tests showed no harmful effects. The substance (C.P. 3) can be classified as non-sensitizer. In the 90-day studies with rats, 5 mg/kg bw C.P. is considered to be the NOAEL. In the teratogenicity study, no signs of maternal or foetal toxicity were observed in the rat after administration of 30 mg/kg bw (NOAEL). It should be noted that the NOAEL stems from a daily exposure for 90 days, whereas human exposure to permanent hair dye is unlikely to be more frequent than once a month. Percutaneous absorption of a formulation was about 0.05.” The substance is currently regulated by the Cosmetics Directive (76/768/EC), Annex III, Part 2 under entry 31 on the list of substances, provisionally allowed, which cosmetic products must not contain except subject to restrictions and conditions laid down. Submission III for HC Red n°","endpoint":"dermal absorption","ingredient":"HC Red No. 13","loael_value":"","noael_unit":"mg/kg bw","noael_value":"30","page":5,"route":"","species":"rat","study_id":"sccp_o_104_noael_002"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption 30 mg/kg bw rat - 90-day dermal absorption SOURCE_SUBDIR=sccp_o_104; REPORT_TITLE=OPINION ON HC Red n° 13 COLIPA n° B31; OPINION_NUMBER=SCCP/1075/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=19 June 2007; VALUE_TEXT=30; DOSE=In the 90-day studies with rats, 5 mg/kg bw C.P. is considered to be the NOAEL.; EFFECT=A 2. The Scientific Committee on Cosmetology (SCC) adopted at its 62nd plenary meeting on 18 January 1996 an opinion (SCC/106/92) with the final conclusion that: “The irritation tests showed no harmful effects. The substance (C.P. 3) can be classified as non-sensitizer. In the 90-day studies with rats, 5 mg/kg bw C.P. is considered to be the NOAEL. In the teratogenicity study, no signs of maternal or foetal toxicity were observed in the rat after administration of 30 mg/kg bw (NOAEL). It should be noted that the NOAEL stems from a daily exposure for 90 days, whereas human exposure to permanent hair dye is unlikely to be more frequent than once a month. Percutaneous absorption of a formulation was about 0.05.” The substance is currently regulated by the Cosmetics Directive (76/768/EC), Annex III, Part 2 under entry 31 on the list of substances, provisionally allowed, which cosmetic products must not contain except subject to restrictions and conditions laid down. Submission III for HC Red n° 13 was submitted by COLIPA in July; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"29705-39-3","citation":"","dose":"In the 90-day studies with rats, 5 mg/kg bw C.P. is considered to be the NOAEL.","duration":"90-day","effect":"A 2. The Scientific Committee on Cosmetology (SCC) adopted at its 62nd plenary meeting on 18 January 1996 an opinion (SCC/106/92) with the final conclusion that: “The irritation tests showed no harmful effects. The substance (C.P. 3) can be classified as non-sensitizer. In the 90-day studies with rats, 5 mg/kg bw C.P. is considered to be the NOAEL. In the teratogenicity study, no signs of maternal or foetal toxicity were observed in the rat after administration of 30 mg/kg bw (NOAEL). It should be noted that the NOAEL stems from a daily exposure for 90 days, whereas human exposure to permanent hair dye is unlikely to be more frequent than once a month. Percutaneous absorption of a formulation was about 0.05.” The substance is currently regulated by the Cosmetics Directive (76/768/EC), Annex III, Part 2 under entry 31 on the list of substances, provisionally allowed, which cosmetic products must not contain except subject to restrictions and conditions laid down. Submission III for HC Red n° 13 was submitted by COLIPA in July","endpoint":"dermal absorption","ingredient":"HC Red No. 13","loael_value":"","noael_unit":"mg/kg bw","noael_value":"30","page":5,"route":"","species":"rat","study_id":"sccp_o_104_noael_003"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption 5 mg/kg bw rat - 90-day dermal absorption SOURCE_SUBDIR=sccs_o_040; REPORT_TITLE=OPINION ON HC Red n° 13 COLIPA n° B31; OPINION_NUMBER=SCCS/1368/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 17 June 2007; VALUE_TEXT=5; DOSE=In the 90-day studies with rats, 5 mg/kg bw.; EFFECT=nitrophenyl)imino]bisethanol hydrochloride was submitted in July 1992 by COLIPA1 according to COLIPA. Submission II for HC Red n° 13 was submitted in April 1995 by COLIPA according to COLIPA. The Scientific Committee on Cosmetology (SCC) adopted at its 62nd plenary meeting the 18 January 1996 an opinion with the final conclusion that: “The irritation tests showed no harmful effects. The substance (C.P.2) can be classified as non sensitizer. In the 90-day studies with rats, 5 mg/kg bw. C.P. is considered to be the NOAEL. In the teratogenicity study, no signs of maternal or foetal toxicity were observed in the rat after administration of 30 mg/kg bw (NOAEL). It should be noted that the NOAEL stems from a daily exposure for 90 days, whereas human exposure to permanent hair dye is unlikely to be more frequent than once a month. Percutaneous absorption of a formulation was about 0.05.” Submission II for HC Red n° 13 was submitted by COLIPA in July 2005. The second opinion (SCCP/1075/07) was adopted on 17 June 2007 with the conclusion; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"29705-39-3","citation":"","dose":"In the 90-day studies with rats, 5 mg/kg bw.","duration":"90-day","effect":"nitrophenyl)imino]bisethanol hydrochloride was submitted in July 1992 by COLIPA1 according to COLIPA. Submission II for HC Red n° 13 was submitted in April 1995 by COLIPA according to COLIPA. The Scientific Committee on Cosmetology (SCC) adopted at its 62nd plenary meeting the 18 January 1996 an opinion with the final conclusion that: “The irritation tests showed no harmful effects. The substance (C.P.2) can be classified as non sensitizer. In the 90-day studies with rats, 5 mg/kg bw. C.P. is considered to be the NOAEL. In the teratogenicity study, no signs of maternal or foetal toxicity were observed in the rat after administration of 30 mg/kg bw (NOAEL). It should be noted that the NOAEL stems from a daily exposure for 90 days, whereas human exposure to permanent hair dye is unlikely to be more frequent than once a month. Percutaneous absorption of a formulation was about 0.05.” Submission II for HC Red n° 13 was submitted by COLIPA in July 2005. The second opinion (SCCP/1075/07) was adopted on 17 June 2007 with the conclusion","endpoint":"dermal absorption","ingredient":"HC Red No. 13","loael_value":"","noael_unit":"mg/kg bw","noael_value":"5","page":5,"route":"","species":"rat","study_id":"sccs_o_040_noael_001"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption 30 mg/kg bw rat - 90-day dermal absorption SOURCE_SUBDIR=sccs_o_040; REPORT_TITLE=OPINION ON HC Red n° 13 COLIPA n° B31; OPINION_NUMBER=SCCS/1368/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 17 June 2007; VALUE_TEXT=30; DOSE=In the 90-day studies with rats, 5 mg/kg bw.; EFFECT=submitted in April 1995 by COLIPA according to COLIPA. The Scientific Committee on Cosmetology (SCC) adopted at its 62nd plenary meeting the 18 January 1996 an opinion with the final conclusion that: “The irritation tests showed no harmful effects. The substance (C.P.2) can be classified as non sensitizer. In the 90-day studies with rats, 5 mg/kg bw. C.P. is considered to be the NOAEL. In the teratogenicity study, no signs of maternal or foetal toxicity were observed in the rat after administration of 30 mg/kg bw (NOAEL). It should be noted that the NOAEL stems from a daily exposure for 90 days, whereas human exposure to permanent hair dye is unlikely to be more frequent than once a month. Percutaneous absorption of a formulation was about 0.05.” Submission II for HC Red n° 13 was submitted by COLIPA in July 2005. The second opinion (SCCP/1075/07) was adopted on 17 June 2007 with the conclusion "that the information submitted is insufficient to allow a final risk assessment to be carried out. Before any further consideration, an; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"29705-39-3","citation":"","dose":"In the 90-day studies with rats, 5 mg/kg bw.","duration":"90-day","effect":"submitted in April 1995 by COLIPA according to COLIPA. The Scientific Committee on Cosmetology (SCC) adopted at its 62nd plenary meeting the 18 January 1996 an opinion with the final conclusion that: “The irritation tests showed no harmful effects. The substance (C.P.2) can be classified as non sensitizer. In the 90-day studies with rats, 5 mg/kg bw. C.P. is considered to be the NOAEL. In the teratogenicity study, no signs of maternal or foetal toxicity were observed in the rat after administration of 30 mg/kg bw (NOAEL). It should be noted that the NOAEL stems from a daily exposure for 90 days, whereas human exposure to permanent hair dye is unlikely to be more frequent than once a month. Percutaneous absorption of a formulation was about 0.05.” Submission II for HC Red n° 13 was submitted by COLIPA in July 2005. The second opinion (SCCP/1075/07) was adopted on 17 June 2007 with the conclusion \"that the information submitted is insufficient to allow a final risk assessment to be carried out. Before any further consideration, an","endpoint":"dermal absorption","ingredient":"HC Red No. 13","loael_value":"","noael_unit":"mg/kg bw","noael_value":"30","page":5,"route":"","species":"rat","study_id":"sccs_o_040_noael_002"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption 30 mg/kg bw rat - 90-day dermal absorption SOURCE_SUBDIR=sccs_o_040; REPORT_TITLE=OPINION ON HC Red n° 13 COLIPA n° B31; OPINION_NUMBER=SCCS/1368/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 17 June 2007; VALUE_TEXT=30; DOSE=In the 90-day studies with rats, 5 mg/kg bw.; EFFECT=cording to COLIPA. The Scientific Committee on Cosmetology (SCC) adopted at its 62nd plenary meeting the 18 January 1996 an opinion with the final conclusion that: “The irritation tests showed no harmful effects. The substance (C.P.2) can be classified as non sensitizer. In the 90-day studies with rats, 5 mg/kg bw. C.P. is considered to be the NOAEL. In the teratogenicity study, no signs of maternal or foetal toxicity were observed in the rat after administration of 30 mg/kg bw (NOAEL). It should be noted that the NOAEL stems from a daily exposure for 90 days, whereas human exposure to permanent hair dye is unlikely to be more frequent than once a month. Percutaneous absorption of a formulation was about 0.05.” Submission II for HC Red n° 13 was submitted by COLIPA in July 2005. The second opinion (SCCP/1075/07) was adopted on 17 June 2007 with the conclusion "that the information submitted is insufficient to allow a final risk assessment to be carried out. Before any further consideration, an in vitro percutaneous absorption stu; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"29705-39-3","citation":"","dose":"In the 90-day studies with rats, 5 mg/kg bw.","duration":"90-day","effect":"cording to COLIPA. The Scientific Committee on Cosmetology (SCC) adopted at its 62nd plenary meeting the 18 January 1996 an opinion with the final conclusion that: “The irritation tests showed no harmful effects. The substance (C.P.2) can be classified as non sensitizer. In the 90-day studies with rats, 5 mg/kg bw. C.P. is considered to be the NOAEL. In the teratogenicity study, no signs of maternal or foetal toxicity were observed in the rat after administration of 30 mg/kg bw (NOAEL). It should be noted that the NOAEL stems from a daily exposure for 90 days, whereas human exposure to permanent hair dye is unlikely to be more frequent than once a month. Percutaneous absorption of a formulation was about 0.05.” Submission II for HC Red n° 13 was submitted by COLIPA in July 2005. The second opinion (SCCP/1075/07) was adopted on 17 June 2007 with the conclusion \"that the information submitted is insufficient to allow a final risk assessment to be carried out. Before any further consideration, an in vitro percutaneous absorption stu","endpoint":"dermal absorption","ingredient":"HC Red No. 13","loael_value":"","noael_unit":"mg/kg bw","noael_value":"30","page":5,"route":"","species":"rat","study_id":"sccs_o_040_noael_003"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption =0.011 mg/kg bw/d rat oral 90 day dermal absorption SOURCE_SUBDIR=sccs_o_040; REPORT_TITLE=OPINION ON HC Red n° 13 COLIPA n° B31; OPINION_NUMBER=SCCS/1368/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 17 June 2007; VALUE_TEXT== 0.011; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Red n° 13 (non-oxidative conditions) Absorption through the skin A (mean +2 SD) = 1.17 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.68 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x...; EFFECT=oclastogenicity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Red n° 13 (non-oxidative conditions) Absorption through the skin A (mean +2 SD) = 1.17 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.68 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.011 mg/kg bw/d No observed adverse effect level NOAEL = 4.2 mg/kg bw/d (90 day, oral, rat) Margin of Safety NOAEL / SED = 382; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"29705-39-3","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Red n° 13 (non-oxidative conditions) Absorption through the skin A (mean +2 SD) = 1.17 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.68 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x...","duration":"90 day","effect":"oclastogenicity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Red n° 13 (non-oxidative conditions) Absorption through the skin A (mean +2 SD) = 1.17 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.68 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.011 mg/kg bw/d No observed adverse effect level NOAEL = 4.2 mg/kg bw/d (90 day, oral, rat) Margin of Safety NOAEL / SED = 382","endpoint":"dermal absorption","ingredient":"HC Red No. 13","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 0.011","page":32,"route":"oral","species":"rat","study_id":"sccs_o_040_noael_010"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption =4.2 mg/kg bw/d rat oral 90 day dermal absorption SOURCE_SUBDIR=sccs_o_040; REPORT_TITLE=OPINION ON HC Red n° 13 COLIPA n° B31; OPINION_NUMBER=SCCS/1368/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 17 June 2007; VALUE_TEXT== 4.2; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Red n° 13 (non-oxidative conditions) Absorption through the skin A (mean +2 SD) = 1.17 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.68 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x...; EFFECT=d 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Red n° 13 (non-oxidative conditions) Absorption through the skin A (mean +2 SD) = 1.17 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.68 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.011 mg/kg bw/d No observed adverse effect level NOAEL = 4.2 mg/kg bw/d (90 day, oral, rat) Margin of Safety NOAEL / SED = 382; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"29705-39-3","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Red n° 13 (non-oxidative conditions) Absorption through the skin A (mean +2 SD) = 1.17 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.68 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x...","duration":"90 day","effect":"d 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Red n° 13 (non-oxidative conditions) Absorption through the skin A (mean +2 SD) = 1.17 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.68 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.011 mg/kg bw/d No observed adverse effect level NOAEL = 4.2 mg/kg bw/d (90 day, oral, rat) Margin of Safety NOAEL / SED = 382","endpoint":"dermal absorption","ingredient":"HC Red No. 13","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 4.2","page":32,"route":"oral","species":"rat","study_id":"sccs_o_040_noael_011"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption =4.2 mg/kg bw/d rat oral 90 day dermal absorption SOURCE_SUBDIR=sccs_o_040; REPORT_TITLE=OPINION ON HC Red n° 13 COLIPA n° B31; OPINION_NUMBER=SCCS/1368/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 17 June 2007; VALUE_TEXT== 4.2; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Red n° 13 (non-oxidative conditions) Absorption through the skin A (mean +2 SD) = 1.17 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.68 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x...; EFFECT=estigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Red n° 13 (non-oxidative conditions) Absorption through the skin A (mean +2 SD) = 1.17 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.68 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.011 mg/kg bw/d No observed adverse effect level NOAEL = 4.2 mg/kg bw/d (90 day, oral, rat) Margin of Safety NOAEL / SED = 382; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"29705-39-3","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Red n° 13 (non-oxidative conditions) Absorption through the skin A (mean +2 SD) = 1.17 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.68 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x...","duration":"90 day","effect":"estigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Red n° 13 (non-oxidative conditions) Absorption through the skin A (mean +2 SD) = 1.17 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.68 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.011 mg/kg bw/d No observed adverse effect level NOAEL = 4.2 mg/kg bw/d (90 day, oral, rat) Margin of Safety NOAEL / SED = 382","endpoint":"dermal absorption","ingredient":"HC Red No. 13","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 4.2","page":32,"route":"oral","species":"rat","study_id":"sccs_o_040_noael_012"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption =0.01 mg/kg bw/d rat oral 90 day dermal absorption SOURCE_SUBDIR=sccs_o_040; REPORT_TITLE=OPINION ON HC Red n° 13 COLIPA n° B31; OPINION_NUMBER=SCCS/1368/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 17 June 2007; VALUE_TEXT== 0.01; DOSE=SCCS/1368/10 Opinion on HC Red n° 13 ___________________________________________________________________________________________ 33 (oxidative conditions) Absorption through the skin A (mean +2 SD) = 1.03 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.60 mg Typical body weight of human = 60 kg Systemic...; EFFECT=SCCS/1368/10 Opinion on HC Red n° 13 ___________________________________________________________________________________________ 33 (oxidative conditions) Absorption through the skin A (mean +2 SD) = 1.03 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.60 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.01 mg/kg bw/d No observed adverse effect level NOAEL = 4.2 mg/kg bw/d (90 day, oral, rat) Margin of Safety NOAEL / SED = 420 3.3.14. Discussion Physico-chemical specifications HC Red n° 13 is used as a hair colouring agent in semi-permanent hair dye formulations at a maximum on-head concentration of 2.5%. It is also used in oxidative hair dye formulations at a maximum concentration of 2.5%, which after mixing typically in 1:1 ratio with hydrogen peroxide prior to use, corresponds to a final on-head concentration of 1.25% upon application. Batch 4/5/6-1 Fas; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"29705-39-3","citation":"","dose":"SCCS/1368/10 Opinion on HC Red n° 13 ___________________________________________________________________________________________ 33 (oxidative conditions) Absorption through the skin A (mean +2 SD) = 1.03 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.60 mg Typical body weight of human = 60 kg Systemic...","duration":"90 day","effect":"SCCS/1368/10 Opinion on HC Red n° 13 ___________________________________________________________________________________________ 33 (oxidative conditions) Absorption through the skin A (mean +2 SD) = 1.03 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.60 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.01 mg/kg bw/d No observed adverse effect level NOAEL = 4.2 mg/kg bw/d (90 day, oral, rat) Margin of Safety NOAEL / SED = 420 3.3.14. Discussion Physico-chemical specifications HC Red n° 13 is used as a hair colouring agent in semi-permanent hair dye formulations at a maximum on-head concentration of 2.5%. It is also used in oxidative hair dye formulations at a maximum concentration of 2.5%, which after mixing typically in 1:1 ratio with hydrogen peroxide prior to use, corresponds to a final on-head concentration of 1.25% upon application. Batch 4/5/6-1 Fas","endpoint":"dermal absorption","ingredient":"HC Red No. 13","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 0.01","page":33,"route":"oral","species":"rat","study_id":"sccs_o_040_noael_013"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption =4.2 mg/kg bw/d rat oral 90 day dermal absorption SOURCE_SUBDIR=sccs_o_040; REPORT_TITLE=OPINION ON HC Red n° 13 COLIPA n° B31; OPINION_NUMBER=SCCS/1368/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 17 June 2007; VALUE_TEXT== 4.2; DOSE=SCCS/1368/10 Opinion on HC Red n° 13 ___________________________________________________________________________________________ 33 (oxidative conditions) Absorption through the skin A (mean +2 SD) = 1.03 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.60 mg Typical body weight of human = 60 kg Systemic...; EFFECT=SCCS/1368/10 Opinion on HC Red n° 13 ___________________________________________________________________________________________ 33 (oxidative conditions) Absorption through the skin A (mean +2 SD) = 1.03 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.60 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.01 mg/kg bw/d No observed adverse effect level NOAEL = 4.2 mg/kg bw/d (90 day, oral, rat) Margin of Safety NOAEL / SED = 420 3.3.14. Discussion Physico-chemical specifications HC Red n° 13 is used as a hair colouring agent in semi-permanent hair dye formulations at a maximum on-head concentration of 2.5%. It is also used in oxidative hair dye formulations at a maximum concentration of 2.5%, which after mixing typically in 1:1 ratio with hydrogen peroxide prior to use, corresponds to a final on-head concentration of 1.25% upon application. Batch 4/5/6-1 Fass 3 is; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"29705-39-3","citation":"","dose":"SCCS/1368/10 Opinion on HC Red n° 13 ___________________________________________________________________________________________ 33 (oxidative conditions) Absorption through the skin A (mean +2 SD) = 1.03 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.60 mg Typical body weight of human = 60 kg Systemic...","duration":"90 day","effect":"SCCS/1368/10 Opinion on HC Red n° 13 ___________________________________________________________________________________________ 33 (oxidative conditions) Absorption through the skin A (mean +2 SD) = 1.03 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.60 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.01 mg/kg bw/d No observed adverse effect level NOAEL = 4.2 mg/kg bw/d (90 day, oral, rat) Margin of Safety NOAEL / SED = 420 3.3.14. Discussion Physico-chemical specifications HC Red n° 13 is used as a hair colouring agent in semi-permanent hair dye formulations at a maximum on-head concentration of 2.5%. It is also used in oxidative hair dye formulations at a maximum concentration of 2.5%, which after mixing typically in 1:1 ratio with hydrogen peroxide prior to use, corresponds to a final on-head concentration of 1.25% upon application. Batch 4/5/6-1 Fass 3 is","endpoint":"dermal absorption","ingredient":"HC Red No. 13","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 4.2","page":33,"route":"oral","species":"rat","study_id":"sccs_o_040_noael_014"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 5 mg/kg bw/day - - 34 days repeated dose toxicity SOURCE_SUBDIR=sccs_o_040; REPORT_TITLE=OPINION ON HC Red n° 13 COLIPA n° B31; OPINION_NUMBER=SCCS/1368/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 17 June 2007; VALUE_TEXT=5; DOSE=24 Conclusion of the SCCS on sub-chronic toxicity At 10 mg/kg bw/day significant haematological, histopathological and spleen weight changes were observed.; EFFECT=SCCS-rejected applicant NOAEL: f the females during the fist week and on isolated occasions up to 34 days after the start of the study. Ref.: 24 Conclusion of the SCCS on sub-chronic toxicity At 10 mg/kg bw/day significant haematological, histopathological and spleen weight changes were observed. The effects seen at 5 mg/kg bw/day (changes in haematological parameters and clinical chemistry, relative kidney weight), are not considered to be adverse (not consistent, not deviating from the normal range, only relative kidney weight changes). The no observed adverse effect level was therefore considered to be 5 mg/kg bw/day of Kardinalrot, corresponding to 4.2 mg/kg bw/day of HC Red n° 13.; CITATION=Ref.: 24 Conclusion of the SCCS on sub-chronic toxicity At 10 mg/kg bw/day significant haematological, histopathological and spleen weight changes were observed; CITATION_NUMBERS=[24,10]; REFERENCE=Ref.: 24 Conclusion of the SCCS on sub-chronic toxicity At 10 mg/kg bw/day significant haematological, histopathological and spleen weight changes were observed; DETAILS_JSON={"cas_number":"29705-39-3","citation":"Ref.: 24 Conclusion of the SCCS on sub-chronic toxicity At 10 mg/kg bw/day significant haematological, histopathological and spleen weight changes were observed","dose":"24 Conclusion of the SCCS on sub-chronic toxicity At 10 mg/kg bw/day significant haematological, histopathological and spleen weight changes were observed.","duration":"34 days","effect":"SCCS-rejected applicant NOAEL: f the females during the fist week and on isolated occasions up to 34 days after the start of the study. Ref.: 24 Conclusion of the SCCS on sub-chronic toxicity At 10 mg/kg bw/day significant haematological, histopathological and spleen weight changes were observed. The effects seen at 5 mg/kg bw/day (changes in haematological parameters and clinical chemistry, relative kidney weight), are not considered to be adverse (not consistent, not deviating from the normal range, only relative kidney weight changes). The no observed adverse effect level was therefore considered to be 5 mg/kg bw/day of Kardinalrot, corresponding to 4.2 mg/kg bw/day of HC Red n° 13.","endpoint":"repeated dose toxicity","ingredient":"HC Red No. 13","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"5","page":22,"route":"","species":"","study_id":"sccs_o_040_noael_006"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies reproductive toxicity 300 mg/kg bw rat oral 90-day reproductive toxicity SOURCE_SUBDIR=sccp_o_104; REPORT_TITLE=OPINION ON HC Red n° 13 COLIPA n° B31; OPINION_NUMBER=SCCP/1075/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=19 June 2007; VALUE_TEXT=300; DOSE=hyroid was noted in parental animals of either sex (predominantly in males) in all dose groups.; EFFECT=hyroid was noted in parental animals of either sex (predominantly in males) in all dose groups. These effects in the parental animals were related to the treatment with the test substance. Conclusion At the highest test dose, clinical signs in terms of discomfort were noted in both males and females. Similar to the findings in the 90-day study an increase in follicular cell hypertrophy in the thyroid was noted (see Ref.: 22). HC Red n° 13 did not reveal any effect on any reproduction parameter. From this study, a NOAEL of 300 mg/kg bw for reproductive effects was deduced. Ref.: 32 3.3.8.2. Teratogenicity Old study, taken from opinion n° XXIV/1287/97 of 20 May 1998 The test substance (dissolved in water) was given daily from day 5-15 of gestation to groups of 24 pregnant Wistar rats, respectively, (Bor:Wisw-SPF TNO strain) by oral gavage of doses of 5 (group I), 15 (group II) and 30 (group III) mg/kg bw. 24 pregnant females treated with aqua deionised served as controls. Prior to treatment females were 14 weeks old and had a b; CITATION=Ref.: 22); CITATION_NUMBERS=[22]; REFERENCE=Ref.: 22); DETAILS_JSON={"cas_number":"29705-39-3","citation":"Ref.: 22)","dose":"hyroid was noted in parental animals of either sex (predominantly in males) in all dose groups.","duration":"90-day","effect":"hyroid was noted in parental animals of either sex (predominantly in males) in all dose groups. These effects in the parental animals were related to the treatment with the test substance. Conclusion At the highest test dose, clinical signs in terms of discomfort were noted in both males and females. Similar to the findings in the 90-day study an increase in follicular cell hypertrophy in the thyroid was noted (see Ref.: 22). HC Red n° 13 did not reveal any effect on any reproduction parameter. From this study, a NOAEL of 300 mg/kg bw for reproductive effects was deduced. Ref.: 32 3.3.8.2. Teratogenicity Old study, taken from opinion n° XXIV/1287/97 of 20 May 1998 The test substance (dissolved in water) was given daily from day 5-15 of gestation to groups of 24 pregnant Wistar rats, respectively, (Bor:Wisw-SPF TNO strain) by oral gavage of doses of 5 (group I), 15 (group II) and 30 (group III) mg/kg bw. 24 pregnant females treated with aqua deionised served as controls. Prior to treatment females were 14 weeks old and had a b","endpoint":"reproductive toxicity","ingredient":"HC Red No. 13","loael_value":"","noael_unit":"mg/kg bw","noael_value":"300","page":30,"route":"oral","species":"rat","study_id":"sccp_o_104_noael_006"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies reproductive toxicity 4.2 mg/kg bw/day rat dermal 90-day reproductive toxicity SOURCE_SUBDIR=sccp_o_104; REPORT_TITLE=OPINION ON HC Red n° 13 COLIPA n° B31; OPINION_NUMBER=SCCP/1075/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=19 June 2007; VALUE_TEXT=4.2; DOSE=General toxicity LD50 was calculated to be 2120 (1810 - 2480) mg/kg bw.; EFFECT=0 ppb. No documentation was provided to support the data presented in the table "Batch comparison" The stability of the test substance in marketed products was not reported. General toxicity LD50 was calculated to be 2120 (1810 - 2480) mg/kg bw. Based on the effects seen in the 90-day study (changes in haematological parameters and clinical chemistry, relative kidney weight), the Lowest Observed Effect Level was considered to be 5 mg/kg bw/day of Kardinalrot, corresponding to 4.2 mg/kg bw/day of HC Red n° 13. The NOAEL for reproductive effects was set at 300 mg/kg bw/day. A NOAEL of 300 mg/kg bw/day for both materno-toxic and for embryo-foetal effects was deduced. Toxicokinetics In vitro, HC Red n° 13 revealed a Papp of 37.1 x 10-6 cm/sec and thus was classified to be of high permeability. The observed value indicates a good absorption from the gastro- intestinal tract. After dermal application in rats, only minor amounts of HC Red n° 13 are absorbed through the skin and become systemically available. If applied in a hair dye; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"29705-39-3","citation":"","dose":"General toxicity LD50 was calculated to be 2120 (1810 - 2480) mg/kg bw.","duration":"90-day","effect":"0 ppb. No documentation was provided to support the data presented in the table \"Batch comparison\" The stability of the test substance in marketed products was not reported. General toxicity LD50 was calculated to be 2120 (1810 - 2480) mg/kg bw. Based on the effects seen in the 90-day study (changes in haematological parameters and clinical chemistry, relative kidney weight), the Lowest Observed Effect Level was considered to be 5 mg/kg bw/day of Kardinalrot, corresponding to 4.2 mg/kg bw/day of HC Red n° 13. The NOAEL for reproductive effects was set at 300 mg/kg bw/day. A NOAEL of 300 mg/kg bw/day for both materno-toxic and for embryo-foetal effects was deduced. Toxicokinetics In vitro, HC Red n° 13 revealed a Papp of 37.1 x 10-6 cm/sec and thus was classified to be of high permeability. The observed value indicates a good absorption from the gastro- intestinal tract. After dermal application in rats, only minor amounts of HC Red n° 13 are absorbed through the skin and become systemically available. If applied in a hair dye","endpoint":"reproductive toxicity","ingredient":"HC Red No. 13","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"4.2","page":33,"route":"dermal","species":"rat","study_id":"sccp_o_104_noael_009"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies reproductive toxicity 300 mg/kg bw/day rat dermal 90-day reproductive toxicity SOURCE_SUBDIR=sccp_o_104; REPORT_TITLE=OPINION ON HC Red n° 13 COLIPA n° B31; OPINION_NUMBER=SCCP/1075/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=19 June 2007; VALUE_TEXT=300; DOSE=General toxicity LD50 was calculated to be 2120 (1810 - 2480) mg/kg bw.; EFFECT=nted in the table "Batch comparison" The stability of the test substance in marketed products was not reported. General toxicity LD50 was calculated to be 2120 (1810 - 2480) mg/kg bw. Based on the effects seen in the 90-day study (changes in haematological parameters and clinical chemistry, relative kidney weight), the Lowest Observed Effect Level was considered to be 5 mg/kg bw/day of Kardinalrot, corresponding to 4.2 mg/kg bw/day of HC Red n° 13. The NOAEL for reproductive effects was set at 300 mg/kg bw/day. A NOAEL of 300 mg/kg bw/day for both materno-toxic and for embryo-foetal effects was deduced. Toxicokinetics In vitro, HC Red n° 13 revealed a Papp of 37.1 x 10-6 cm/sec and thus was classified to be of high permeability. The observed value indicates a good absorption from the gastro- intestinal tract. After dermal application in rats, only minor amounts of HC Red n° 13 are absorbed through the skin and become systemically available. If applied in a hair dye formulation as vehicle less than 1.1 µg/cm2 of the dye formula; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"29705-39-3","citation":"","dose":"General toxicity LD50 was calculated to be 2120 (1810 - 2480) mg/kg bw.","duration":"90-day","effect":"nted in the table \"Batch comparison\" The stability of the test substance in marketed products was not reported. General toxicity LD50 was calculated to be 2120 (1810 - 2480) mg/kg bw. Based on the effects seen in the 90-day study (changes in haematological parameters and clinical chemistry, relative kidney weight), the Lowest Observed Effect Level was considered to be 5 mg/kg bw/day of Kardinalrot, corresponding to 4.2 mg/kg bw/day of HC Red n° 13. The NOAEL for reproductive effects was set at 300 mg/kg bw/day. A NOAEL of 300 mg/kg bw/day for both materno-toxic and for embryo-foetal effects was deduced. Toxicokinetics In vitro, HC Red n° 13 revealed a Papp of 37.1 x 10-6 cm/sec and thus was classified to be of high permeability. The observed value indicates a good absorption from the gastro- intestinal tract. After dermal application in rats, only minor amounts of HC Red n° 13 are absorbed through the skin and become systemically available. If applied in a hair dye formulation as vehicle less than 1.1 µg/cm2 of the dye formula","endpoint":"reproductive toxicity","ingredient":"HC Red No. 13","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"300","page":33,"route":"dermal","species":"rat","study_id":"sccp_o_104_noael_010"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies reproductive toxicity 300 mg/kg bw/day - - 90-day reproductive toxicity SOURCE_SUBDIR=sccs_o_040; REPORT_TITLE=OPINION ON HC Red n° 13 COLIPA n° B31; OPINION_NUMBER=SCCS/1368/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 17 June 2007; VALUE_TEXT=300; DOSE=hyroid was noted in parental animals of either sex (predominantly in males) in all dose groups.; EFFECT=hyroid was noted in parental animals of either sex (predominantly in males) in all dose groups. These effects in the parental animals were related to the treatment with the test substance. Conclusion At the highest test dose, clinical signs in terms of discomfort were noted in both males and females. Similar to the findings in the 90-day study an increase in follicular cell hypertrophy in the thyroid was noted (see Ref.: 22). HC Red n° 13 did not reveal any effect on any reproduction parameter. From this study, a NOAEL of 300 mg/kg bw/day for reproductive effects was deduced. Ref.: 32 3.3.8.2. Teratogenicity Old study, taken from opinion n° XXIV/1287/97 of 20 May 1998; CITATION=Ref.: 22); CITATION_NUMBERS=[22]; REFERENCE=Ref.: 22); DETAILS_JSON={"cas_number":"29705-39-3","citation":"Ref.: 22)","dose":"hyroid was noted in parental animals of either sex (predominantly in males) in all dose groups.","duration":"90-day","effect":"hyroid was noted in parental animals of either sex (predominantly in males) in all dose groups. These effects in the parental animals were related to the treatment with the test substance. Conclusion At the highest test dose, clinical signs in terms of discomfort were noted in both males and females. Similar to the findings in the 90-day study an increase in follicular cell hypertrophy in the thyroid was noted (see Ref.: 22). HC Red n° 13 did not reveal any effect on any reproduction parameter. From this study, a NOAEL of 300 mg/kg bw/day for reproductive effects was deduced. Ref.: 32 3.3.8.2. Teratogenicity Old study, taken from opinion n° XXIV/1287/97 of 20 May 1998","endpoint":"reproductive toxicity","ingredient":"HC Red No. 13","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"300","page":29,"route":"","species":"","study_id":"sccs_o_040_noael_007"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies reproductive toxicity 5 mg/kg bw/day rat dermal - reproductive toxicity SOURCE_SUBDIR=sccs_o_040; REPORT_TITLE=OPINION ON HC Red n° 13 COLIPA n° B31; OPINION_NUMBER=SCCS/1368/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 17 June 2007; VALUE_TEXT=5; DOSE=General toxicity LD50 was calculated to be 2120 (1810 - 2480) mg/kg bw.; EFFECT=ported. The test substance was sufficiently stable in the presence of hydrogen peroxide. General toxicity LD50 was calculated to be 2120 (1810 - 2480) mg/kg bw. At 10 mg/kg bw/day significant haematological, histopathological and spleen weight changes were observed. The effects seen at 5 mg/kg bw/day (changes in haematological parameters and clinical chemistry, relative kidney weight), are not considered to be adverse (not consistent, not deviating from the normal range, only relative kidney weight changes). The no observed adverse effect level was therefore considered to be 5 mg/kg bw/day of Kardinalrot, corresponding to 4.2 mg/kg bw/day of HC Red n° 13. The NOAEL for reproductive effects was set at 300 mg/kg bw/day. A NOAEL of 300 mg/kg bw/day for both materno-toxic and for embryo-foetal effects was deduced. Toxicokinetics In vitro, HC Red n° 13 revealed a Papp of 37.1 x 10-6 cm/sec and thus was classified to be of high permeability. The observed value indicates a good absorption from the gastro- intestinal tract. After dermal application in rats, on; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"29705-39-3","citation":"","dose":"General toxicity LD50 was calculated to be 2120 (1810 - 2480) mg/kg bw.","duration":"","effect":"ported. The test substance was sufficiently stable in the presence of hydrogen peroxide. General toxicity LD50 was calculated to be 2120 (1810 - 2480) mg/kg bw. At 10 mg/kg bw/day significant haematological, histopathological and spleen weight changes were observed. The effects seen at 5 mg/kg bw/day (changes in haematological parameters and clinical chemistry, relative kidney weight), are not considered to be adverse (not consistent, not deviating from the normal range, only relative kidney weight changes). The no observed adverse effect level was therefore considered to be 5 mg/kg bw/day of Kardinalrot, corresponding to 4.2 mg/kg bw/day of HC Red n° 13. The NOAEL for reproductive effects was set at 300 mg/kg bw/day. A NOAEL of 300 mg/kg bw/day for both materno-toxic and for embryo-foetal effects was deduced. Toxicokinetics In vitro, HC Red n° 13 revealed a Papp of 37.1 x 10-6 cm/sec and thus was classified to be of high permeability. The observed value indicates a good absorption from the gastro- intestinal tract. After dermal application in rats, on","endpoint":"reproductive toxicity","ingredient":"HC Red No. 13","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"5","page":33,"route":"dermal","species":"rat","study_id":"sccs_o_040_noael_015"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies reproductive toxicity 4.2 mg/kg bw/day rat dermal - reproductive toxicity SOURCE_SUBDIR=sccs_o_040; REPORT_TITLE=OPINION ON HC Red n° 13 COLIPA n° B31; OPINION_NUMBER=SCCS/1368/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 17 June 2007; VALUE_TEXT=4.2; DOSE=At 10 mg/kg bw/day significant haematological, histopathological and spleen weight changes were observed.; EFFECT=0) mg/kg bw. At 10 mg/kg bw/day significant haematological, histopathological and spleen weight changes were observed. The effects seen at 5 mg/kg bw/day (changes in haematological parameters and clinical chemistry, relative kidney weight), are not considered to be adverse (not consistent, not deviating from the normal range, only relative kidney weight changes). The no observed adverse effect level was therefore considered to be 5 mg/kg bw/day of Kardinalrot, corresponding to 4.2 mg/kg bw/day of HC Red n° 13. The NOAEL for reproductive effects was set at 300 mg/kg bw/day. A NOAEL of 300 mg/kg bw/day for both materno-toxic and for embryo-foetal effects was deduced. Toxicokinetics In vitro, HC Red n° 13 revealed a Papp of 37.1 x 10-6 cm/sec and thus was classified to be of high permeability. The observed value indicates a good absorption from the gastro- intestinal tract. After dermal application in rats, only minor amounts of HC Red n° 13 are absorbed through the skin and become systemically available. If applied in a hair dye; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"29705-39-3","citation":"","dose":"At 10 mg/kg bw/day significant haematological, histopathological and spleen weight changes were observed.","duration":"","effect":"0) mg/kg bw. At 10 mg/kg bw/day significant haematological, histopathological and spleen weight changes were observed. The effects seen at 5 mg/kg bw/day (changes in haematological parameters and clinical chemistry, relative kidney weight), are not considered to be adverse (not consistent, not deviating from the normal range, only relative kidney weight changes). The no observed adverse effect level was therefore considered to be 5 mg/kg bw/day of Kardinalrot, corresponding to 4.2 mg/kg bw/day of HC Red n° 13. The NOAEL for reproductive effects was set at 300 mg/kg bw/day. A NOAEL of 300 mg/kg bw/day for both materno-toxic and for embryo-foetal effects was deduced. Toxicokinetics In vitro, HC Red n° 13 revealed a Papp of 37.1 x 10-6 cm/sec and thus was classified to be of high permeability. The observed value indicates a good absorption from the gastro- intestinal tract. After dermal application in rats, only minor amounts of HC Red n° 13 are absorbed through the skin and become systemically available. If applied in a hair dye","endpoint":"reproductive toxicity","ingredient":"HC Red No. 13","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"4.2","page":33,"route":"dermal","species":"rat","study_id":"sccs_o_040_noael_016"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies reproductive toxicity 300 mg/kg bw/day rat dermal - reproductive toxicity SOURCE_SUBDIR=sccs_o_040; REPORT_TITLE=OPINION ON HC Red n° 13 COLIPA n° B31; OPINION_NUMBER=SCCS/1368/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 17 June 2007; VALUE_TEXT=300; DOSE=The effects seen at 5 mg/kg bw/day (changes in haematological parameters and clinical chemistry, relative kidney weight), are not considered to be adverse (not consistent, not deviating from the normal range, only relative kidney weight changes).; EFFECT=stopathological and spleen weight changes were observed. The effects seen at 5 mg/kg bw/day (changes in haematological parameters and clinical chemistry, relative kidney weight), are not considered to be adverse (not consistent, not deviating from the normal range, only relative kidney weight changes). The no observed adverse effect level was therefore considered to be 5 mg/kg bw/day of Kardinalrot, corresponding to 4.2 mg/kg bw/day of HC Red n° 13. The NOAEL for reproductive effects was set at 300 mg/kg bw/day. A NOAEL of 300 mg/kg bw/day for both materno-toxic and for embryo-foetal effects was deduced. Toxicokinetics In vitro, HC Red n° 13 revealed a Papp of 37.1 x 10-6 cm/sec and thus was classified to be of high permeability. The observed value indicates a good absorption from the gastro- intestinal tract. After dermal application in rats, only minor amounts of HC Red n° 13 are absorbed through the skin and become systemically available. If applied in a hair dye formulation less than 1.1 μg/cm2 of the dye formulation penetr; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"29705-39-3","citation":"","dose":"The effects seen at 5 mg/kg bw/day (changes in haematological parameters and clinical chemistry, relative kidney weight), are not considered to be adverse (not consistent, not deviating from the normal range, only relative kidney weight changes).","duration":"","effect":"stopathological and spleen weight changes were observed. The effects seen at 5 mg/kg bw/day (changes in haematological parameters and clinical chemistry, relative kidney weight), are not considered to be adverse (not consistent, not deviating from the normal range, only relative kidney weight changes). The no observed adverse effect level was therefore considered to be 5 mg/kg bw/day of Kardinalrot, corresponding to 4.2 mg/kg bw/day of HC Red n° 13. The NOAEL for reproductive effects was set at 300 mg/kg bw/day. A NOAEL of 300 mg/kg bw/day for both materno-toxic and for embryo-foetal effects was deduced. Toxicokinetics In vitro, HC Red n° 13 revealed a Papp of 37.1 x 10-6 cm/sec and thus was classified to be of high permeability. The observed value indicates a good absorption from the gastro- intestinal tract. After dermal application in rats, only minor amounts of HC Red n° 13 are absorbed through the skin and become systemically available. If applied in a hair dye formulation less than 1.1 μg/cm2 of the dye formulation penetr","endpoint":"reproductive toxicity","ingredient":"HC Red No. 13","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"300","page":33,"route":"dermal","species":"rat","study_id":"sccs_o_040_noael_017"}
openFDA substances 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
openFDA substances FDA UNII substance identifier 3S057K0K0B UNII - - - chemical {"approval_status":null,"molecular_formula":"C10H15N3O4.ClH","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"3S057K0K0B"}
openFDA substances FDA UNII substance identifier 3S057K0K0B UNII - - - chemical {"approval_status":null,"molecular_formula":"C10H15N3O4.ClH","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"3S057K0K0B"}
openFDA substances FDA UNII substance identifier 3S057K0K0B UNII - - - chemical {"approval_status":null,"molecular_formula":"C10H15N3O4.ClH","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"3S057K0K0B"}
openFDA substances FDA UNII substance identifier 3S057K0K0B UNII - - - chemical {"approval_status":null,"molecular_formula":"C10H15N3O4.ClH","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"3S057K0K0B"}