NOAEL Studies
Cosmetic Ingredient
Basic Brown 16 NOAEL Studies
INCI: BASIC BROWN 16
CAS: 26381-41-9
Raw No Observed Adverse Effect Level endpoint records grouped by source. This page does not render calculated Margin of Safety values.
COSMOS_DB 2 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| COSMOS_DB | LOAEL | 150 | mg/kg bw/day | rat | oral | 13 week | Subchronic | SCCS; Potokar, M., et al. (1985) Arianor Mahogany. 90-Tage-Test nach wiederholter oralerVerabreichung an Ratten. Institut für Toxikologie, Henkel KGaA, Düsseldorf, Germany.Archive code at Henkel KGaA, Düsseldorf: TBD 850004 |
| COSMOS_DB | NOAEL | 50 | mg/kg bw/day | rat | oral | 13 week | Subchronic | SCCS; Potokar, M., et al. (1985) Arianor Mahogany. 90-Tage-Test nach wiederholter oralerVerabreichung an Ratten. Institut für Toxikologie, Henkel KGaA, Düsseldorf, Germany.Archive code at Henkel KGaA, Düsseldorf: TBD 850004 |
SCCNFP_vision_codex 8 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| SCCNFP_vision_codex | NOAEL | =50 | mg/kg | rabbit | dermal | Sub-chronic | repeated dose toxicity | {"citation":"Ref. : 7 2","dose":"Coloured urine was excreted by animals treated with 150 and 450 mg/kg, throughout the treatment period.","effect":"_____ 7 neurotoxic symptoms. Macroscopic and histological evaluation revealed discoloration of the inner organs. At 150mg/kg bw there was a decrease in body weight gain in male animals (again from week 1, with a terminal mean bodyweight of 93% of control), but no other toxicological effects were reported. Coloured urine was excreted by animals treated with 150 and 450 mg/kg, throughout the treatment period. The dose of 50mg/kg body weight was tolerated without any signs of adverse effects and is regarded to be the NOAEL. Ref. : 7 2.3.8. Sub-chronic dermal toxicity No data 2.3.9. Sub-chronic inhalation toxicity No data 2.3.10. Chronic toxicity No data 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Test on undiluted material Guideline : / Species : New Zealand white rabbit Route : skin Group sizes : 3 male and 3 female Material : undiluted Basic Brown 16 Batch no : not stated Dose : 0.5 g/in2 GLP : not in compliance Undiluted Basic Brown 16 was applied at a dose of 0.5 g/in2 to the backs of 3 rabbits of each sex with shorn","page":7,"pdf":"out_198.pdf","row_type":"noael_study","study_id":"out_198_noael_001"} |
| SCCNFP_vision_codex | NOAEL | =50 | mg/kg | rabbit | dermal | Sub-chronic | repeated dose toxicity | {"citation":"Ref. : 7 2","dose":"Coloured urine was excreted by animals treated with 150 and 450 mg/kg, throughout the treatment period.","effect":"_____ 7 neurotoxic symptoms. Macroscopic and histological evaluation revealed discoloration of the inner organs. At 150mg/kg bw there was a decrease in body weight gain in male animals (again from week 1, with a terminal mean bodyweight of 93% of control), but no other toxicological effects were reported. Coloured urine was excreted by animals treated with 150 and 450 mg/kg, throughout the treatment period. The dose of 50mg/kg body weight was tolerated without any signs of adverse effects and is regarded to be the NOAEL. Ref. : 7 2.3.8. Sub-chronic dermal toxicity No data 2.3.9. Sub-chronic inhalation toxicity No data 2.3.10. Chronic toxicity No data 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Test on undiluted material Guideline : / Species : New Zealand white rabbit Route : skin Group sizes : 3 male and 3 female Material : undiluted Basic Brown 16 Batch no : not stated Dose : 0.5 g/in2 GLP : not in compliance Undiluted Basic Brown 16 was applied at a dose of 0.5 g/in2 to the backs of 3 rabbits of each sex with shorn","page":7,"pdf":"out_198.pdf","row_type":"noael_study","study_id":"out_198_noael_001"} |
| SCCNFP_vision_codex | NOAEL | =50 | mg/kg | rabbit | dermal | Sub-chronic | repeated dose toxicity | {"citation":"Ref. : 7 2","dose":"Coloured urine was excreted by animals treated with 150 and 450 mg/kg, throughout the treatment period.","effect":"_____ 7 neurotoxic symptoms. Macroscopic and histological evaluation revealed discoloration of the inner organs. At 150mg/kg bw there was a decrease in body weight gain in male animals (again from week 1, with a terminal mean bodyweight of 93% of control), but no other toxicological effects were reported. Coloured urine was excreted by animals treated with 150 and 450 mg/kg, throughout the treatment period. The dose of 50mg/kg body weight was tolerated without any signs of adverse effects and is regarded to be the NOAEL. Ref. : 7 2.3.8. Sub-chronic dermal toxicity No data 2.3.9. Sub-chronic inhalation toxicity No data 2.3.10. Chronic toxicity No data 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Test on undiluted material Guideline : / Species : New Zealand white rabbit Route : skin Group sizes : 3 male and 3 female Material : undiluted Basic Brown 16 Batch no : not stated Dose : 0.5 g/in2 GLP : not in compliance Undiluted Basic Brown 16 was applied at a dose of 0.5 g/in2 to the backs of 3 rabbits of each sex with shorn","page":7,"pdf":"out_198.pdf","row_type":"noael_study","study_id":"out_198_noael_001"} |
| SCCNFP_vision_codex | NOAEL | =50 | mg/kg | rabbit | dermal | Sub-chronic | repeated dose toxicity | {"citation":"Ref. : 7 2","dose":"Coloured urine was excreted by animals treated with 150 and 450 mg/kg, throughout the treatment period.","effect":"_____ 7 neurotoxic symptoms. Macroscopic and histological evaluation revealed discoloration of the inner organs. At 150mg/kg bw there was a decrease in body weight gain in male animals (again from week 1, with a terminal mean bodyweight of 93% of control), but no other toxicological effects were reported. Coloured urine was excreted by animals treated with 150 and 450 mg/kg, throughout the treatment period. The dose of 50mg/kg body weight was tolerated without any signs of adverse effects and is regarded to be the NOAEL. Ref. : 7 2.3.8. Sub-chronic dermal toxicity No data 2.3.9. Sub-chronic inhalation toxicity No data 2.3.10. Chronic toxicity No data 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Test on undiluted material Guideline : / Species : New Zealand white rabbit Route : skin Group sizes : 3 male and 3 female Material : undiluted Basic Brown 16 Batch no : not stated Dose : 0.5 g/in2 GLP : not in compliance Undiluted Basic Brown 16 was applied at a dose of 0.5 g/in2 to the backs of 3 rabbits of each sex with shorn","page":7,"pdf":"out_198.pdf","row_type":"noael_study","study_id":"out_198_noael_001"} |
| SCCNFP_vision_codex | NOAEL | >94 | % | human | dermal | - | dermal absorption | {"citation":"Ref. : 12 2","dose":"The study is considered inadequate, because only one dose was tested.","effect":"was not different from the control. The study is considered inadequate, because only one dose was tested. Ref. : 12 2.11. Safety evaluation NOT APPLICABLE CALCULATION OF THE MARGIN OF SAFETY (Basic Brown 16) (semipermanent) Based on a usage volume of 35 ml, containing at maximum … % Maximum absorption through the skin A (µg/cm2) = µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = cm2 Dermal absorption per treatment SAS x A x 0.001 = mg Systemic exposure dose (SED) SAS x A x 0.001/60 = mg/kg No observed adverse effect level (mg/kg) NOAEL = mg/kg (species, study) Margin of Safety NOAEL / SED = 2.12. Conclusions Commercial grade dye of different batches have been used for various tests, but purity (>94%) of the dye has been described only in one case. The impurities in the dye should be described. The test substance is an azo-dye, therefore, free aromatic amine content in the dye (in all batches) is required. The dye formulation contains approximately 15 % sugar and 6% inorganic salts. A complete description of the sugar and salts is r","page":13,"pdf":"out_198.pdf","row_type":"noael_study","study_id":"out_198_noael_002"} |
| SCCNFP_vision_codex | NOAEL | >94 | % | human | dermal | - | dermal absorption | {"citation":"Ref. : 12 2","dose":"The study is considered inadequate, because only one dose was tested.","effect":"was not different from the control. The study is considered inadequate, because only one dose was tested. Ref. : 12 2.11. Safety evaluation NOT APPLICABLE CALCULATION OF THE MARGIN OF SAFETY (Basic Brown 16) (semipermanent) Based on a usage volume of 35 ml, containing at maximum … % Maximum absorption through the skin A (µg/cm2) = µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = cm2 Dermal absorption per treatment SAS x A x 0.001 = mg Systemic exposure dose (SED) SAS x A x 0.001/60 = mg/kg No observed adverse effect level (mg/kg) NOAEL = mg/kg (species, study) Margin of Safety NOAEL / SED = 2.12. Conclusions Commercial grade dye of different batches have been used for various tests, but purity (>94%) of the dye has been described only in one case. The impurities in the dye should be described. The test substance is an azo-dye, therefore, free aromatic amine content in the dye (in all batches) is required. The dye formulation contains approximately 15 % sugar and 6% inorganic salts. A complete description of the sugar and salts is r","page":13,"pdf":"out_198.pdf","row_type":"noael_study","study_id":"out_198_noael_002"} |
| SCCNFP_vision_codex | NOAEL | >94 | % | human | dermal | - | dermal absorption | {"citation":"Ref. : 12 2","dose":"The study is considered inadequate, because only one dose was tested.","effect":"was not different from the control. The study is considered inadequate, because only one dose was tested. Ref. : 12 2.11. Safety evaluation NOT APPLICABLE CALCULATION OF THE MARGIN OF SAFETY (Basic Brown 16) (semipermanent) Based on a usage volume of 35 ml, containing at maximum … % Maximum absorption through the skin A (µg/cm2) = µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = cm2 Dermal absorption per treatment SAS x A x 0.001 = mg Systemic exposure dose (SED) SAS x A x 0.001/60 = mg/kg No observed adverse effect level (mg/kg) NOAEL = mg/kg (species, study) Margin of Safety NOAEL / SED = 2.12. Conclusions Commercial grade dye of different batches have been used for various tests, but purity (>94%) of the dye has been described only in one case. The impurities in the dye should be described. The test substance is an azo-dye, therefore, free aromatic amine content in the dye (in all batches) is required. The dye formulation contains approximately 15 % sugar and 6% inorganic salts. A complete description of the sugar and salts is r","page":13,"pdf":"out_198.pdf","row_type":"noael_study","study_id":"out_198_noael_002"} |
| SCCNFP_vision_codex | NOAEL | >94 | % | human | dermal | - | dermal absorption | {"citation":"Ref. : 12 2","dose":"The study is considered inadequate, because only one dose was tested.","effect":"was not different from the control. The study is considered inadequate, because only one dose was tested. Ref. : 12 2.11. Safety evaluation NOT APPLICABLE CALCULATION OF THE MARGIN OF SAFETY (Basic Brown 16) (semipermanent) Based on a usage volume of 35 ml, containing at maximum … % Maximum absorption through the skin A (µg/cm2) = µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = cm2 Dermal absorption per treatment SAS x A x 0.001 = mg Systemic exposure dose (SED) SAS x A x 0.001/60 = mg/kg No observed adverse effect level (mg/kg) NOAEL = mg/kg (species, study) Margin of Safety NOAEL / SED = 2.12. Conclusions Commercial grade dye of different batches have been used for various tests, but purity (>94%) of the dye has been described only in one case. The impurities in the dye should be described. The test substance is an azo-dye, therefore, free aromatic amine content in the dye (in all batches) is required. The dye formulation contains approximately 15 % sugar and 6% inorganic salts. A complete description of the sugar and salts is r","page":13,"pdf":"out_198.pdf","row_type":"noael_study","study_id":"out_198_noael_002"} |
SCCS_vision_codex 80 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| SCCS_vision_codex | NOAEL | =50 | % | - | - | 90-day | NOAEL study | {"citation":"Ref: 1 Comment The Purity by NMR = 65","dose":"The 90-day NOAEL dose of the batch KS 6024 needs to be corrected according to the dye content.","effect":"nformation it can be concluded that the former not fully described batch is representative and the specification of the contained dye is quite similar to the fully characterized batch 57861/2. Ref: 1 Comment The Purity by NMR = 65.7% (w/w) stated in the Summary submission III for the batch KS 6024 is contradictory to the data reported in the specific analytical file (ref. 5), according to which the content is 50-60% by UV/VIS analysis using the extinction coefficients calculated for the batch 57861/2. The 90-day NOAEL dose of the batch KS 6024 needs to be corrected according to the dye content. 3.1.5. Impurities / accompanying contaminants In addition to the NTBRI (7-Hydroxy-N,N,N-trimethyl-naphthalen-2-aminium chloride) mentioned in the previous section 3.1.4, at least 10 additional impurities were detected (but not identified) by HPLC in batch 57861/2, representing about 0.5%. Comparable HPLC data are not provided for the other batches, but the number of additional non-identified impurities may be more taking into account","page":8,"pdf":"sccp_o_142.pdf","row_type":"noael_study","study_id":"sccp_o_142_noael_001"} |
| SCCS_vision_codex | NOAEL | =65.7 | % | - | - | Chronic | genotoxicity | {"citation":"Ref.: 15 Comment As the dye content of the test substance is only 65","dose":"At 150 mg/kg bw/day, there was a decrease in body weight gain in male animals (again from week 1, with a terminal mean bodyweight of 93% of control), but no other toxicological effects were reported.","effect":"oxic symptoms. Macroscopic and histological evaluation revealed discoloration of the inner organs. At 150 mg/kg bw/day, there was a decrease in body weight gain in male animals (again from week 1, with a terminal mean bodyweight of 93% of control), but no other toxicological effects were reported. Coloured urine was excreted by animals treated with 150 and 450 mg/kg, throughout the treatment period. Conclusion The dose of 50 mg/kg bw/day was tolerated without any signs of adverse effects and is regarded to be the NOAEL. Ref.: 15 Comment As the dye content of the test substance is only 65.7%, the NOAEL value is re-calculated to be 33 mg/kg/bw/day. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Test Guideline: OECD 471 (1997) Species/strain: Salmonella typhimurium TA98, TA100, TA102, TA1535 and TA1537 Replicates: triplicates in 2 individual experiments both in the presence and absence of S9-mix. Test substan","page":16,"pdf":"sccp_o_142.pdf","row_type":"noael_study","study_id":"sccp_o_142_noael_002"} |
| SCCS_vision_codex | NOAEL | =90 | mg/kg | rat | - | - | developmental toxicity | {"dose":"Conclusion At the high dosage of 180 mg/kg bw/day, C009 caused slight maternal toxicity as indicated by the reduction in body weight gain on GD 9 when compared with controls.","effect":"weight (from 30 to 47%) compared with control mean foetal weight. Conclusion At the high dosage of 180 mg/kg bw/day, C009 caused slight maternal toxicity as indicated by the reduction in body weight gain on GD 9 when compared with controls. As a consequence of the maternal toxicity, a mean reduced foetal weight was observed and a delay in the ossification of some bones was noted at the skeletal examination. Neither embryotoxic nor teratogenic effects of C009 has been found in rats under the study conditions. The NOAEL both for maternal and embryo foetal toxicity was considered to be 90 mg/kg","page":21,"pdf":"sccp_o_142.pdf","row_type":"noael_study","study_id":"sccp_o_142_noael_004"} |
| SCCS_vision_codex | NOAEL | =50 | mg/kg bw/day | rat | oral | 90-day | carcinogenicity | {"dose":"The cleavage of the azo-group may release para-phenylenediamine (PPD) General toxicity The acute median lethal oral dose (LD50) of Basic Brown 16 was reported to be between 2 and 4 g/kg bw.","effect":"ied impurities were detected by HPLC, which were not characterised. Methylbromide is classified by the EU as mutagenic category 3; methylchloride is classified by the EU as carcinogenic category 3 The stability data of Basic Brown 16 in the test solutions and in the marketed product is not reported. The cleavage of the azo-group may release para-phenylenediamine (PPD) General toxicity The acute median lethal oral dose (LD50) of Basic Brown 16 was reported to be between 2 and 4 g/kg bw. In a 90-day rat study, the NOAEL was considered to be 50 mg/kg bw/day, based on decreased body weight gain and some neurotoxic symptoms in both sexes. This value was re-calculated to 33 mg/kg bw/day based on the dye content of the test substance. The NOAEL both for maternal and embryo-foetal toxicity was considered to be 90 mg/kg bw/day. This value was re-calculated to 59 mg/kg bw/day based on the dye content of the test substance.","page":22,"pdf":"sccp_o_142.pdf","row_type":"noael_study","study_id":"sccp_o_142_noael_006"} |
| SCCS_vision_codex | NOAEL | =33 | mg/kg bw/day | rat | oral | 90-day | NOAEL study | {"dose":"The cleavage of the azo-group may release para-phenylenediamine (PPD) General toxicity The acute median lethal oral dose (LD50) of Basic Brown 16 was reported to be between 2 and 4 g/kg bw.","effect":"Brown 16 in the test solutions and in the marketed product is not reported. The cleavage of the azo-group may release para-phenylenediamine (PPD) General toxicity The acute median lethal oral dose (LD50) of Basic Brown 16 was reported to be between 2 and 4 g/kg bw. In a 90-day rat study, the NOAEL was considered to be 50 mg/kg bw/day, based on decreased body weight gain and some neurotoxic symptoms in both sexes. This value was re-calculated to 33 mg/kg bw/day based on the dye content of the test substance. The NOAEL both for maternal and embryo-foetal toxicity was considered to be 90 mg/kg bw/day. This value was re-calculated to 59 mg/kg bw/day based on the dye content of the test substance.","page":22,"pdf":"sccp_o_142.pdf","row_type":"noael_study","study_id":"sccp_o_142_noael_007"} |
| SCCS_vision_codex | NOAEL | =8 | - | - | - | 90-day | NOAEL study | {"dose":"The 90-day NOAEL dose of the batch KS 6024 needs to be corrected according to the dye","effect":"Unlabeled table on page 8: The 90-day NOAEL dose of the batch KS 6024 needs to be corrected according to the dye","page":8,"pdf":"sccp_o_142.pdf","row_type":"noael_study","study_id":"sccp_o_142_noael_008"} |
| SCCS_vision_codex | NOAEL | =3.1 | - | - | - | - | NOAEL study | {"effect":"Unlabeled table on page 8: 3.1.5. Impurities / accompanying contaminants","page":8,"pdf":"sccp_o_142.pdf","row_type":"noael_study","study_id":"sccp_o_142_noael_009"} |
| SCCS_vision_codex | NOAEL | =7 | - | - | - | - | NOAEL study | {"effect":"Unlabeled table on page 8: In addition to the NTBRI (7-Hydroxy-N,N,N-trimethyl-naphthalen-2-aminium chloride)","page":8,"pdf":"sccp_o_142.pdf","row_type":"noael_study","study_id":"sccp_o_142_noael_010"} |
| SCCS_vision_codex | NOAEL | =0.5 | % | - | - | - | NOAEL study | {"effect":"Unlabeled table on page 8: not identified) by HPLC in batch 57861/2, representing about 0.5%.","page":8,"pdf":"sccp_o_142.pdf","row_type":"noael_study","study_id":"sccp_o_142_noael_012"} |
| SCCS_vision_codex | NOAEL | =1.2 | % | - | - | - | NOAEL study | {"effect":"Unlabeled table on page 8: non-identified impurities may be more taking into account that their total content is 1.2%.","page":8,"pdf":"sccp_o_142.pdf","row_type":"noael_study","study_id":"sccp_o_142_noael_013"} |
| SCCS_vision_codex | NOAEL | =6024 | - | - | - | - | NOAEL study | {"effect":"Unlabeled table on page 8: Also, the content of NTBRI in the batch KS 6024 was found much higher than in the batch","page":8,"pdf":"sccp_o_142.pdf","row_type":"noael_study","study_id":"sccp_o_142_noael_014"} |
| SCCS_vision_codex | NOAEL | =89.1 | % | - | - | - | NOAEL study | {"effect":"Unlabeled table on page 8: batch 57861/2 Basic Brown 16 = 89.1% NTBRI = 0.13% (0.13/89.1 = 0.0015)","page":8,"pdf":"sccp_o_142.pdf","row_type":"noael_study","study_id":"sccp_o_142_noael_015"} |
| SCCS_vision_codex | NOAEL | =100 | - | - | - | - | NOAEL study | {"effect":"Unlabeled table on page 8: Water: > 100 g/l at room temperature","page":8,"pdf":"sccp_o_142.pdf","row_type":"noael_study","study_id":"sccp_o_142_noael_018"} |
| SCCS_vision_codex | NOAEL | =10 | - | - | - | - | NOAEL study | {"effect":"Unlabeled table on page 8: Ethanol: 10-100 g/l at room temperature","page":8,"pdf":"sccp_o_142.pdf","row_type":"noael_study","study_id":"sccp_o_142_noael_019"} |
| SCCS_vision_codex | NOAEL | =1.66 | - | - | - | - | NOAEL study | {"effect":"Unlabeled table on page 8: Log Po/w: (calc. Syracuse Vers. 1.66): 0.88","page":8,"pdf":"sccp_o_142.pdf","row_type":"noael_study","study_id":"sccp_o_142_noael_022"} |
| SCCS_vision_codex | NOAEL | =169 | - | - | - | - | NOAEL study | {"effect":"Unlabeled table on page 8: Melting point: 169-175 °C (in SCCNFP/0667/03 it was 160-170 °C-","page":8,"pdf":"sccp_o_142.pdf","row_type":"noael_study","study_id":"sccp_o_142_noael_024"} |
| SCCS_vision_codex | NOAEL | =90 | mg/kg bw/day | rat | - | - | reproductive toxicity | {"dose":"The NOAEL both for maternal and embryo foetal toxicity was considered to be 90 mg/kg bw/day.","effect":"ot of Basic Brown 16. Hence, the SCCS considers that a concern for the potential of Basic Brown 16 (including the new batch VW230921A) to induce gene mutations and chromosomal aberrations remains. 3.3.7. Carcinogenicity SCCS comment As genotoxicity of Basic Brown 16 cannot be excluded, the SCCS considers that the concerns for carcinogenicity cannot be ruled out. 3.3.8. Reproductive toxicity From SCCS/1496/12: “Neither embryotoxic nor teratogenic effects have been found in rats under the study conditions. The NOAEL both for maternal and embryo foetal toxicity was considered to be 90 mg/kg bw/day. As the dye content of the test substance is only 65.7%, the NOAEL value is re-calculated to 59 mg/kg bw/day.” 3.3.9. Toxicokinetics 3.3.9.1. Toxicokinetics in laboratory animals /","page":24,"pdf":"sccs_o_305.pdf","row_type":"noael_study","study_id":"sccs_o_305_noael_003"} |
| SCCS_vision_codex | NOAEL | =0.095 | mg/kg bw | rat | oral | 90-day | dermal absorption | {"dose":"The NOAEL of 33 mg/kg bw/day from the 90-d oral study is adjusted considering a 50% oral absorption factor.","effect":"2 SD (5.15 + 2 x 2.32 = 9.79 μg/cm² is used for calculating the MOS. The NOAEL of 33 mg/kg bw/day from the 90-d oral study is adjusted considering a 50% oral absorption factor. CALCULATION OF THE MARGIN OF SAFETY (……. conditions) (…..% formulation, on head concentration …..%) Absorption through the skin A = 9.79 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 5.68 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.095 mg/kg bw No observed adverse effect level NOAEL = 33 mg/kg bw/d (90-day, oral, rat) Default oral absorption = 50% Bioavailability 50%* = 16.5 mg/kg bw/d","page":25,"pdf":"sccs_o_305.pdf","row_type":"noael_study","study_id":"sccs_o_305_noael_006"} |
| SCCS_vision_codex | NOAEL | =33 | mg/kg bw/d | - | oral | - | irritation | {"dose":"A NOAEL of 33 mg/kg bw/d has been identified in a 90-d oral study, it covers the NOAEL of 59 mg/kg bw/d in the teratogenicity study.","effect":"SCCS/1684/25 Final version Scientific Advice on hair dye ‘Basic Brown 16’ (C009) (CAS No. 26381-41-9, EC No. 247-640-9) – submission V ter. _________________________________________________________________________________________________________________ 26 Margin of Safety adjusted NOAEL/SED = 174.4 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. The Margin of Safety for BASIC BROWN 16 is 174 for the expected use. Conclusion by the Applicant BASIC BROWN 16 is non acutely toxic. It is not irritant for the skin and it is a moderate skin sensitizer. A NOAEL of 33 mg/kg bw/d has been identified in a 90-d oral study, it covers the NOAEL of 59 mg/kg bw/d in the teratogenicity study. This allows the calculation of a sa","page":26,"pdf":"sccs_o_305.pdf","row_type":"noael_study","study_id":"sccs_o_305_noael_008"} |
| SCCS_vision_codex | NOAEL | =59 | mg/kg bw/d | - | oral | - | irritation | {"dose":"A NOAEL of 33 mg/kg bw/d has been identified in a 90-d oral study, it covers the NOAEL of 59 mg/kg bw/d in the teratogenicity study.","effect":"SCCS-rejected applicant NOAEL: _________________________________________________ 26 Margin of Safety adjusted NOAEL/SED = 174.4 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. The Margin of Safety for BASIC BROWN 16 is 174 for the expected use. Conclusion by the Applicant BASIC BROWN 16 is non acutely toxic. It is not irritant for the skin and it is a moderate skin sensitizer. A NOAEL of 33 mg/kg bw/d has been identified in a 90-d oral study, it covers the NOAEL of 59 mg/kg bw/d in the teratogenicity study. This allows the calculation of a safe margin of safety for the expected use as hair dye at 2%. It is noteworthy that the SCCS evaluated a similar substance (BB17) in 2014 and concluded it to be safe for use in non-oxidative hair dye formulations. The same positive effects were limited to bacteria models. Some limitation in the tests in mammalian systems where observed. It was not considered mutagenic in an in vitro micronucleus test, and negative in a micronucleus test","page":26,"pdf":"sccs_o_305.pdf","row_type":"noael_study","study_id":"sccs_o_305_noael_010"} |
| SCCS_vision_codex | NOAEL | =50 | % | - | - | 90-day | NOAEL study | {"citation":"Ref: 1 Comment The Purity by NMR = 65","dose":"The 90-day NOAEL dose of the batch KS 6024 needs to be corrected according to the dye content.","effect":"nformation it can be concluded that the former not fully described batch is representative and the specification of the contained dye is quite similar to the fully characterized batch 57861/2. Ref: 1 Comment The Purity by NMR = 65.7% (w/w) stated in the Summary submission III for the batch KS 6024 is contradictory to the data reported in the specific analytical file (ref. 5), according to which the content is 50-60% by UV/VIS analysis using the extinction coefficients calculated for the batch 57861/2. The 90-day NOAEL dose of the batch KS 6024 needs to be corrected according to the dye content. 3.1.5. Impurities / accompanying contaminants In addition to the NTBRI (7-Hydroxy-N,N,N-trimethyl-naphthalen-2-aminium chloride) mentioned in the previous section 3.1.4, at least 10 additional impurities were detected (but not identified) by HPLC in batch 57861/2, representing about 0.5%. Comparable HPLC data are not provided for the other batches, but the number of additional non-identified impurities may be more taking into account","page":8,"pdf":"sccp_o_142.pdf","row_type":"noael_study","study_id":"sccp_o_142_noael_001"} |
| SCCS_vision_codex | NOAEL | =65.7 | % | - | - | Chronic | genotoxicity | {"citation":"Ref.: 15 Comment As the dye content of the test substance is only 65","dose":"At 150 mg/kg bw/day, there was a decrease in body weight gain in male animals (again from week 1, with a terminal mean bodyweight of 93% of control), but no other toxicological effects were reported.","effect":"oxic symptoms. Macroscopic and histological evaluation revealed discoloration of the inner organs. At 150 mg/kg bw/day, there was a decrease in body weight gain in male animals (again from week 1, with a terminal mean bodyweight of 93% of control), but no other toxicological effects were reported. Coloured urine was excreted by animals treated with 150 and 450 mg/kg, throughout the treatment period. Conclusion The dose of 50 mg/kg bw/day was tolerated without any signs of adverse effects and is regarded to be the NOAEL. Ref.: 15 Comment As the dye content of the test substance is only 65.7%, the NOAEL value is re-calculated to be 33 mg/kg/bw/day. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Test Guideline: OECD 471 (1997) Species/strain: Salmonella typhimurium TA98, TA100, TA102, TA1535 and TA1537 Replicates: triplicates in 2 individual experiments both in the presence and absence of S9-mix. Test substan","page":16,"pdf":"sccp_o_142.pdf","row_type":"noael_study","study_id":"sccp_o_142_noael_002"} |
| SCCS_vision_codex | NOAEL | =90 | mg/kg | rat | - | - | developmental toxicity | {"dose":"Conclusion At the high dosage of 180 mg/kg bw/day, C009 caused slight maternal toxicity as indicated by the reduction in body weight gain on GD 9 when compared with controls.","effect":"weight (from 30 to 47%) compared with control mean foetal weight. Conclusion At the high dosage of 180 mg/kg bw/day, C009 caused slight maternal toxicity as indicated by the reduction in body weight gain on GD 9 when compared with controls. As a consequence of the maternal toxicity, a mean reduced foetal weight was observed and a delay in the ossification of some bones was noted at the skeletal examination. Neither embryotoxic nor teratogenic effects of C009 has been found in rats under the study conditions. The NOAEL both for maternal and embryo foetal toxicity was considered to be 90 mg/kg","page":21,"pdf":"sccp_o_142.pdf","row_type":"noael_study","study_id":"sccp_o_142_noael_004"} |
| SCCS_vision_codex | NOAEL | =50 | mg/kg bw/day | rat | oral | 90-day | carcinogenicity | {"dose":"The cleavage of the azo-group may release para-phenylenediamine (PPD) General toxicity The acute median lethal oral dose (LD50) of Basic Brown 16 was reported to be between 2 and 4 g/kg bw.","effect":"ied impurities were detected by HPLC, which were not characterised. Methylbromide is classified by the EU as mutagenic category 3; methylchloride is classified by the EU as carcinogenic category 3 The stability data of Basic Brown 16 in the test solutions and in the marketed product is not reported. The cleavage of the azo-group may release para-phenylenediamine (PPD) General toxicity The acute median lethal oral dose (LD50) of Basic Brown 16 was reported to be between 2 and 4 g/kg bw. In a 90-day rat study, the NOAEL was considered to be 50 mg/kg bw/day, based on decreased body weight gain and some neurotoxic symptoms in both sexes. This value was re-calculated to 33 mg/kg bw/day based on the dye content of the test substance. The NOAEL both for maternal and embryo-foetal toxicity was considered to be 90 mg/kg bw/day. This value was re-calculated to 59 mg/kg bw/day based on the dye content of the test substance.","page":22,"pdf":"sccp_o_142.pdf","row_type":"noael_study","study_id":"sccp_o_142_noael_006"} |
| SCCS_vision_codex | NOAEL | =33 | mg/kg bw/day | rat | oral | 90-day | NOAEL study | {"dose":"The cleavage of the azo-group may release para-phenylenediamine (PPD) General toxicity The acute median lethal oral dose (LD50) of Basic Brown 16 was reported to be between 2 and 4 g/kg bw.","effect":"Brown 16 in the test solutions and in the marketed product is not reported. The cleavage of the azo-group may release para-phenylenediamine (PPD) General toxicity The acute median lethal oral dose (LD50) of Basic Brown 16 was reported to be between 2 and 4 g/kg bw. In a 90-day rat study, the NOAEL was considered to be 50 mg/kg bw/day, based on decreased body weight gain and some neurotoxic symptoms in both sexes. This value was re-calculated to 33 mg/kg bw/day based on the dye content of the test substance. The NOAEL both for maternal and embryo-foetal toxicity was considered to be 90 mg/kg bw/day. This value was re-calculated to 59 mg/kg bw/day based on the dye content of the test substance.","page":22,"pdf":"sccp_o_142.pdf","row_type":"noael_study","study_id":"sccp_o_142_noael_007"} |
| SCCS_vision_codex | NOAEL | =8 | - | - | - | 90-day | NOAEL study | {"dose":"The 90-day NOAEL dose of the batch KS 6024 needs to be corrected according to the dye","effect":"Unlabeled table on page 8: The 90-day NOAEL dose of the batch KS 6024 needs to be corrected according to the dye","page":8,"pdf":"sccp_o_142.pdf","row_type":"noael_study","study_id":"sccp_o_142_noael_008"} |
| SCCS_vision_codex | NOAEL | =3.1 | - | - | - | - | NOAEL study | {"effect":"Unlabeled table on page 8: 3.1.5. Impurities / accompanying contaminants","page":8,"pdf":"sccp_o_142.pdf","row_type":"noael_study","study_id":"sccp_o_142_noael_009"} |
| SCCS_vision_codex | NOAEL | =7 | - | - | - | - | NOAEL study | {"effect":"Unlabeled table on page 8: In addition to the NTBRI (7-Hydroxy-N,N,N-trimethyl-naphthalen-2-aminium chloride)","page":8,"pdf":"sccp_o_142.pdf","row_type":"noael_study","study_id":"sccp_o_142_noael_010"} |
| SCCS_vision_codex | NOAEL | =0.5 | % | - | - | - | NOAEL study | {"effect":"Unlabeled table on page 8: not identified) by HPLC in batch 57861/2, representing about 0.5%.","page":8,"pdf":"sccp_o_142.pdf","row_type":"noael_study","study_id":"sccp_o_142_noael_012"} |
| SCCS_vision_codex | NOAEL | =1.2 | % | - | - | - | NOAEL study | {"effect":"Unlabeled table on page 8: non-identified impurities may be more taking into account that their total content is 1.2%.","page":8,"pdf":"sccp_o_142.pdf","row_type":"noael_study","study_id":"sccp_o_142_noael_013"} |
| SCCS_vision_codex | NOAEL | =6024 | - | - | - | - | NOAEL study | {"effect":"Unlabeled table on page 8: Also, the content of NTBRI in the batch KS 6024 was found much higher than in the batch","page":8,"pdf":"sccp_o_142.pdf","row_type":"noael_study","study_id":"sccp_o_142_noael_014"} |
| SCCS_vision_codex | NOAEL | =89.1 | % | - | - | - | NOAEL study | {"effect":"Unlabeled table on page 8: batch 57861/2 Basic Brown 16 = 89.1% NTBRI = 0.13% (0.13/89.1 = 0.0015)","page":8,"pdf":"sccp_o_142.pdf","row_type":"noael_study","study_id":"sccp_o_142_noael_015"} |
| SCCS_vision_codex | NOAEL | =100 | - | - | - | - | NOAEL study | {"effect":"Unlabeled table on page 8: Water: > 100 g/l at room temperature","page":8,"pdf":"sccp_o_142.pdf","row_type":"noael_study","study_id":"sccp_o_142_noael_018"} |
| SCCS_vision_codex | NOAEL | =10 | - | - | - | - | NOAEL study | {"effect":"Unlabeled table on page 8: Ethanol: 10-100 g/l at room temperature","page":8,"pdf":"sccp_o_142.pdf","row_type":"noael_study","study_id":"sccp_o_142_noael_019"} |
| SCCS_vision_codex | NOAEL | =1.66 | - | - | - | - | NOAEL study | {"effect":"Unlabeled table on page 8: Log Po/w: (calc. Syracuse Vers. 1.66): 0.88","page":8,"pdf":"sccp_o_142.pdf","row_type":"noael_study","study_id":"sccp_o_142_noael_022"} |
| SCCS_vision_codex | NOAEL | =169 | - | - | - | - | NOAEL study | {"effect":"Unlabeled table on page 8: Melting point: 169-175 °C (in SCCNFP/0667/03 it was 160-170 °C-","page":8,"pdf":"sccp_o_142.pdf","row_type":"noael_study","study_id":"sccp_o_142_noael_024"} |
| SCCS_vision_codex | NOAEL | =50 | % | - | - | 90-day | NOAEL study | {"citation":"Ref: 1 Comment The Purity by NMR = 65","dose":"The 90-day NOAEL dose of the batch KS 6024 needs to be corrected according to the dye content.","effect":"nformation it can be concluded that the former not fully described batch is representative and the specification of the contained dye is quite similar to the fully characterized batch 57861/2. Ref: 1 Comment The Purity by NMR = 65.7% (w/w) stated in the Summary submission III for the batch KS 6024 is contradictory to the data reported in the specific analytical file (ref. 5), according to which the content is 50-60% by UV/VIS analysis using the extinction coefficients calculated for the batch 57861/2. The 90-day NOAEL dose of the batch KS 6024 needs to be corrected according to the dye content. 3.1.5. Impurities / accompanying contaminants In addition to the NTBRI (7-Hydroxy-N,N,N-trimethyl-naphthalen-2-aminium chloride) mentioned in the previous section 3.1.4, at least 10 additional impurities were detected (but not identified) by HPLC in batch 57861/2, representing about 0.5%. Comparable HPLC data are not provided for the other batches, but the number of additional non-identified impurities may be more taking into account","page":8,"pdf":"sccp_o_142.pdf","row_type":"noael_study","study_id":"sccp_o_142_noael_001"} |
| SCCS_vision_codex | NOAEL | =65.7 | % | - | - | Chronic | genotoxicity | {"citation":"Ref.: 15 Comment As the dye content of the test substance is only 65","dose":"At 150 mg/kg bw/day, there was a decrease in body weight gain in male animals (again from week 1, with a terminal mean bodyweight of 93% of control), but no other toxicological effects were reported.","effect":"oxic symptoms. Macroscopic and histological evaluation revealed discoloration of the inner organs. At 150 mg/kg bw/day, there was a decrease in body weight gain in male animals (again from week 1, with a terminal mean bodyweight of 93% of control), but no other toxicological effects were reported. Coloured urine was excreted by animals treated with 150 and 450 mg/kg, throughout the treatment period. Conclusion The dose of 50 mg/kg bw/day was tolerated without any signs of adverse effects and is regarded to be the NOAEL. Ref.: 15 Comment As the dye content of the test substance is only 65.7%, the NOAEL value is re-calculated to be 33 mg/kg/bw/day. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Test Guideline: OECD 471 (1997) Species/strain: Salmonella typhimurium TA98, TA100, TA102, TA1535 and TA1537 Replicates: triplicates in 2 individual experiments both in the presence and absence of S9-mix. Test substan","page":16,"pdf":"sccp_o_142.pdf","row_type":"noael_study","study_id":"sccp_o_142_noael_002"} |
| SCCS_vision_codex | NOAEL | =90 | mg/kg | rat | - | - | developmental toxicity | {"dose":"Conclusion At the high dosage of 180 mg/kg bw/day, C009 caused slight maternal toxicity as indicated by the reduction in body weight gain on GD 9 when compared with controls.","effect":"weight (from 30 to 47%) compared with control mean foetal weight. Conclusion At the high dosage of 180 mg/kg bw/day, C009 caused slight maternal toxicity as indicated by the reduction in body weight gain on GD 9 when compared with controls. As a consequence of the maternal toxicity, a mean reduced foetal weight was observed and a delay in the ossification of some bones was noted at the skeletal examination. Neither embryotoxic nor teratogenic effects of C009 has been found in rats under the study conditions. The NOAEL both for maternal and embryo foetal toxicity was considered to be 90 mg/kg","page":21,"pdf":"sccp_o_142.pdf","row_type":"noael_study","study_id":"sccp_o_142_noael_004"} |
| SCCS_vision_codex | NOAEL | =50 | mg/kg bw/day | rat | oral | 90-day | carcinogenicity | {"dose":"The cleavage of the azo-group may release para-phenylenediamine (PPD) General toxicity The acute median lethal oral dose (LD50) of Basic Brown 16 was reported to be between 2 and 4 g/kg bw.","effect":"ied impurities were detected by HPLC, which were not characterised. Methylbromide is classified by the EU as mutagenic category 3; methylchloride is classified by the EU as carcinogenic category 3 The stability data of Basic Brown 16 in the test solutions and in the marketed product is not reported. The cleavage of the azo-group may release para-phenylenediamine (PPD) General toxicity The acute median lethal oral dose (LD50) of Basic Brown 16 was reported to be between 2 and 4 g/kg bw. In a 90-day rat study, the NOAEL was considered to be 50 mg/kg bw/day, based on decreased body weight gain and some neurotoxic symptoms in both sexes. This value was re-calculated to 33 mg/kg bw/day based on the dye content of the test substance. The NOAEL both for maternal and embryo-foetal toxicity was considered to be 90 mg/kg bw/day. This value was re-calculated to 59 mg/kg bw/day based on the dye content of the test substance.","page":22,"pdf":"sccp_o_142.pdf","row_type":"noael_study","study_id":"sccp_o_142_noael_006"} |
| SCCS_vision_codex | NOAEL | =33 | mg/kg bw/day | rat | oral | 90-day | NOAEL study | {"dose":"The cleavage of the azo-group may release para-phenylenediamine (PPD) General toxicity The acute median lethal oral dose (LD50) of Basic Brown 16 was reported to be between 2 and 4 g/kg bw.","effect":"Brown 16 in the test solutions and in the marketed product is not reported. The cleavage of the azo-group may release para-phenylenediamine (PPD) General toxicity The acute median lethal oral dose (LD50) of Basic Brown 16 was reported to be between 2 and 4 g/kg bw. In a 90-day rat study, the NOAEL was considered to be 50 mg/kg bw/day, based on decreased body weight gain and some neurotoxic symptoms in both sexes. This value was re-calculated to 33 mg/kg bw/day based on the dye content of the test substance. The NOAEL both for maternal and embryo-foetal toxicity was considered to be 90 mg/kg bw/day. This value was re-calculated to 59 mg/kg bw/day based on the dye content of the test substance.","page":22,"pdf":"sccp_o_142.pdf","row_type":"noael_study","study_id":"sccp_o_142_noael_007"} |
| SCCS_vision_codex | NOAEL | =8 | - | - | - | 90-day | NOAEL study | {"dose":"The 90-day NOAEL dose of the batch KS 6024 needs to be corrected according to the dye","effect":"Unlabeled table on page 8: The 90-day NOAEL dose of the batch KS 6024 needs to be corrected according to the dye","page":8,"pdf":"sccp_o_142.pdf","row_type":"noael_study","study_id":"sccp_o_142_noael_008"} |
| SCCS_vision_codex | NOAEL | =3.1 | - | - | - | - | NOAEL study | {"effect":"Unlabeled table on page 8: 3.1.5. Impurities / accompanying contaminants","page":8,"pdf":"sccp_o_142.pdf","row_type":"noael_study","study_id":"sccp_o_142_noael_009"} |
| SCCS_vision_codex | NOAEL | =7 | - | - | - | - | NOAEL study | {"effect":"Unlabeled table on page 8: In addition to the NTBRI (7-Hydroxy-N,N,N-trimethyl-naphthalen-2-aminium chloride)","page":8,"pdf":"sccp_o_142.pdf","row_type":"noael_study","study_id":"sccp_o_142_noael_010"} |
| SCCS_vision_codex | NOAEL | =0.5 | % | - | - | - | NOAEL study | {"effect":"Unlabeled table on page 8: not identified) by HPLC in batch 57861/2, representing about 0.5%.","page":8,"pdf":"sccp_o_142.pdf","row_type":"noael_study","study_id":"sccp_o_142_noael_012"} |
| SCCS_vision_codex | NOAEL | =1.2 | % | - | - | - | NOAEL study | {"effect":"Unlabeled table on page 8: non-identified impurities may be more taking into account that their total content is 1.2%.","page":8,"pdf":"sccp_o_142.pdf","row_type":"noael_study","study_id":"sccp_o_142_noael_013"} |
| SCCS_vision_codex | NOAEL | =6024 | - | - | - | - | NOAEL study | {"effect":"Unlabeled table on page 8: Also, the content of NTBRI in the batch KS 6024 was found much higher than in the batch","page":8,"pdf":"sccp_o_142.pdf","row_type":"noael_study","study_id":"sccp_o_142_noael_014"} |
| SCCS_vision_codex | NOAEL | =89.1 | % | - | - | - | NOAEL study | {"effect":"Unlabeled table on page 8: batch 57861/2 Basic Brown 16 = 89.1% NTBRI = 0.13% (0.13/89.1 = 0.0015)","page":8,"pdf":"sccp_o_142.pdf","row_type":"noael_study","study_id":"sccp_o_142_noael_015"} |
| SCCS_vision_codex | NOAEL | =100 | - | - | - | - | NOAEL study | {"effect":"Unlabeled table on page 8: Water: > 100 g/l at room temperature","page":8,"pdf":"sccp_o_142.pdf","row_type":"noael_study","study_id":"sccp_o_142_noael_018"} |
| SCCS_vision_codex | NOAEL | =10 | - | - | - | - | NOAEL study | {"effect":"Unlabeled table on page 8: Ethanol: 10-100 g/l at room temperature","page":8,"pdf":"sccp_o_142.pdf","row_type":"noael_study","study_id":"sccp_o_142_noael_019"} |
| SCCS_vision_codex | NOAEL | =1.66 | - | - | - | - | NOAEL study | {"effect":"Unlabeled table on page 8: Log Po/w: (calc. Syracuse Vers. 1.66): 0.88","page":8,"pdf":"sccp_o_142.pdf","row_type":"noael_study","study_id":"sccp_o_142_noael_022"} |
| SCCS_vision_codex | NOAEL | =169 | - | - | - | - | NOAEL study | {"effect":"Unlabeled table on page 8: Melting point: 169-175 °C (in SCCNFP/0667/03 it was 160-170 °C-","page":8,"pdf":"sccp_o_142.pdf","row_type":"noael_study","study_id":"sccp_o_142_noael_024"} |
| SCCS_vision_codex | NOAEL | =90 | mg/kg bw/day | rat | - | - | reproductive toxicity | {"dose":"The NOAEL both for maternal and embryo foetal toxicity was considered to be 90 mg/kg bw/day.","effect":"ot of Basic Brown 16. Hence, the SCCS considers that a concern for the potential of Basic Brown 16 (including the new batch VW230921A) to induce gene mutations and chromosomal aberrations remains. 3.3.7. Carcinogenicity SCCS comment As genotoxicity of Basic Brown 16 cannot be excluded, the SCCS considers that the concerns for carcinogenicity cannot be ruled out. 3.3.8. Reproductive toxicity From SCCS/1496/12: “Neither embryotoxic nor teratogenic effects have been found in rats under the study conditions. The NOAEL both for maternal and embryo foetal toxicity was considered to be 90 mg/kg bw/day. As the dye content of the test substance is only 65.7%, the NOAEL value is re-calculated to 59 mg/kg bw/day.” 3.3.9. Toxicokinetics 3.3.9.1. Toxicokinetics in laboratory animals /","page":24,"pdf":"sccs_o_305.pdf","row_type":"noael_study","study_id":"sccs_o_305_noael_003"} |
| SCCS_vision_codex | NOAEL | =0.095 | mg/kg bw | rat | oral | 90-day | dermal absorption | {"dose":"The NOAEL of 33 mg/kg bw/day from the 90-d oral study is adjusted considering a 50% oral absorption factor.","effect":"2 SD (5.15 + 2 x 2.32 = 9.79 μg/cm² is used for calculating the MOS. The NOAEL of 33 mg/kg bw/day from the 90-d oral study is adjusted considering a 50% oral absorption factor. CALCULATION OF THE MARGIN OF SAFETY (……. conditions) (…..% formulation, on head concentration …..%) Absorption through the skin A = 9.79 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 5.68 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.095 mg/kg bw No observed adverse effect level NOAEL = 33 mg/kg bw/d (90-day, oral, rat) Default oral absorption = 50% Bioavailability 50%* = 16.5 mg/kg bw/d","page":25,"pdf":"sccs_o_305.pdf","row_type":"noael_study","study_id":"sccs_o_305_noael_006"} |
| SCCS_vision_codex | NOAEL | =33 | mg/kg bw/d | - | oral | - | irritation | {"dose":"A NOAEL of 33 mg/kg bw/d has been identified in a 90-d oral study, it covers the NOAEL of 59 mg/kg bw/d in the teratogenicity study.","effect":"SCCS/1684/25 Final version Scientific Advice on hair dye ‘Basic Brown 16’ (C009) (CAS No. 26381-41-9, EC No. 247-640-9) – submission V ter. _________________________________________________________________________________________________________________ 26 Margin of Safety adjusted NOAEL/SED = 174.4 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. The Margin of Safety for BASIC BROWN 16 is 174 for the expected use. Conclusion by the Applicant BASIC BROWN 16 is non acutely toxic. It is not irritant for the skin and it is a moderate skin sensitizer. A NOAEL of 33 mg/kg bw/d has been identified in a 90-d oral study, it covers the NOAEL of 59 mg/kg bw/d in the teratogenicity study. This allows the calculation of a sa","page":26,"pdf":"sccs_o_305.pdf","row_type":"noael_study","study_id":"sccs_o_305_noael_008"} |
| SCCS_vision_codex | NOAEL | =59 | mg/kg bw/d | - | oral | - | irritation | {"dose":"A NOAEL of 33 mg/kg bw/d has been identified in a 90-d oral study, it covers the NOAEL of 59 mg/kg bw/d in the teratogenicity study.","effect":"SCCS-rejected applicant NOAEL: _________________________________________________ 26 Margin of Safety adjusted NOAEL/SED = 174.4 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. The Margin of Safety for BASIC BROWN 16 is 174 for the expected use. Conclusion by the Applicant BASIC BROWN 16 is non acutely toxic. It is not irritant for the skin and it is a moderate skin sensitizer. A NOAEL of 33 mg/kg bw/d has been identified in a 90-d oral study, it covers the NOAEL of 59 mg/kg bw/d in the teratogenicity study. This allows the calculation of a safe margin of safety for the expected use as hair dye at 2%. It is noteworthy that the SCCS evaluated a similar substance (BB17) in 2014 and concluded it to be safe for use in non-oxidative hair dye formulations. The same positive effects were limited to bacteria models. Some limitation in the tests in mammalian systems where observed. It was not considered mutagenic in an in vitro micronucleus test, and negative in a micronucleus test","page":26,"pdf":"sccs_o_305.pdf","row_type":"noael_study","study_id":"sccs_o_305_noael_010"} |
| SCCS_vision_codex | NOAEL | =90 | mg/kg bw/day | rat | - | - | reproductive toxicity | {"dose":"The NOAEL both for maternal and embryo foetal toxicity was considered to be 90 mg/kg bw/day.","effect":"ot of Basic Brown 16. Hence, the SCCS considers that a concern for the potential of Basic Brown 16 (including the new batch VW230921A) to induce gene mutations and chromosomal aberrations remains. 3.3.7. Carcinogenicity SCCS comment As genotoxicity of Basic Brown 16 cannot be excluded, the SCCS considers that the concerns for carcinogenicity cannot be ruled out. 3.3.8. Reproductive toxicity From SCCS/1496/12: “Neither embryotoxic nor teratogenic effects have been found in rats under the study conditions. The NOAEL both for maternal and embryo foetal toxicity was considered to be 90 mg/kg bw/day. As the dye content of the test substance is only 65.7%, the NOAEL value is re-calculated to 59 mg/kg bw/day.” 3.3.9. Toxicokinetics 3.3.9.1. Toxicokinetics in laboratory animals /","page":24,"pdf":"sccs_o_305.pdf","row_type":"noael_study","study_id":"sccs_o_305_noael_003"} |
| SCCS_vision_codex | NOAEL | =0.095 | mg/kg bw | rat | oral | 90-day | dermal absorption | {"dose":"The NOAEL of 33 mg/kg bw/day from the 90-d oral study is adjusted considering a 50% oral absorption factor.","effect":"2 SD (5.15 + 2 x 2.32 = 9.79 μg/cm² is used for calculating the MOS. The NOAEL of 33 mg/kg bw/day from the 90-d oral study is adjusted considering a 50% oral absorption factor. CALCULATION OF THE MARGIN OF SAFETY (……. conditions) (…..% formulation, on head concentration …..%) Absorption through the skin A = 9.79 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 5.68 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.095 mg/kg bw No observed adverse effect level NOAEL = 33 mg/kg bw/d (90-day, oral, rat) Default oral absorption = 50% Bioavailability 50%* = 16.5 mg/kg bw/d","page":25,"pdf":"sccs_o_305.pdf","row_type":"noael_study","study_id":"sccs_o_305_noael_006"} |
| SCCS_vision_codex | NOAEL | =33 | mg/kg bw/d | - | oral | - | irritation | {"dose":"A NOAEL of 33 mg/kg bw/d has been identified in a 90-d oral study, it covers the NOAEL of 59 mg/kg bw/d in the teratogenicity study.","effect":"SCCS/1684/25 Final version Scientific Advice on hair dye ‘Basic Brown 16’ (C009) (CAS No. 26381-41-9, EC No. 247-640-9) – submission V ter. _________________________________________________________________________________________________________________ 26 Margin of Safety adjusted NOAEL/SED = 174.4 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. The Margin of Safety for BASIC BROWN 16 is 174 for the expected use. Conclusion by the Applicant BASIC BROWN 16 is non acutely toxic. It is not irritant for the skin and it is a moderate skin sensitizer. A NOAEL of 33 mg/kg bw/d has been identified in a 90-d oral study, it covers the NOAEL of 59 mg/kg bw/d in the teratogenicity study. This allows the calculation of a sa","page":26,"pdf":"sccs_o_305.pdf","row_type":"noael_study","study_id":"sccs_o_305_noael_008"} |
| SCCS_vision_codex | NOAEL | =59 | mg/kg bw/d | - | oral | - | irritation | {"dose":"A NOAEL of 33 mg/kg bw/d has been identified in a 90-d oral study, it covers the NOAEL of 59 mg/kg bw/d in the teratogenicity study.","effect":"SCCS-rejected applicant NOAEL: _________________________________________________ 26 Margin of Safety adjusted NOAEL/SED = 174.4 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. The Margin of Safety for BASIC BROWN 16 is 174 for the expected use. Conclusion by the Applicant BASIC BROWN 16 is non acutely toxic. It is not irritant for the skin and it is a moderate skin sensitizer. A NOAEL of 33 mg/kg bw/d has been identified in a 90-d oral study, it covers the NOAEL of 59 mg/kg bw/d in the teratogenicity study. This allows the calculation of a safe margin of safety for the expected use as hair dye at 2%. It is noteworthy that the SCCS evaluated a similar substance (BB17) in 2014 and concluded it to be safe for use in non-oxidative hair dye formulations. The same positive effects were limited to bacteria models. Some limitation in the tests in mammalian systems where observed. It was not considered mutagenic in an in vitro micronucleus test, and negative in a micronucleus test","page":26,"pdf":"sccs_o_305.pdf","row_type":"noael_study","study_id":"sccs_o_305_noael_010"} |
| SCCS_vision_codex | NOAEL | =50 | % | - | - | 90-day | NOAEL study | {"citation":"Ref: 1 Comment The Purity by NMR = 65","dose":"The 90-day NOAEL dose of the batch KS 6024 needs to be corrected according to the dye content.","effect":"nformation it can be concluded that the former not fully described batch is representative and the specification of the contained dye is quite similar to the fully characterized batch 57861/2. Ref: 1 Comment The Purity by NMR = 65.7% (w/w) stated in the Summary submission III for the batch KS 6024 is contradictory to the data reported in the specific analytical file (ref. 5), according to which the content is 50-60% by UV/VIS analysis using the extinction coefficients calculated for the batch 57861/2. The 90-day NOAEL dose of the batch KS 6024 needs to be corrected according to the dye content. 3.1.5. Impurities / accompanying contaminants In addition to the NTBRI (7-Hydroxy-N,N,N-trimethyl-naphthalen-2-aminium chloride) mentioned in the previous section 3.1.4, at least 10 additional impurities were detected (but not identified) by HPLC in batch 57861/2, representing about 0.5%. Comparable HPLC data are not provided for the other batches, but the number of additional non-identified impurities may be more taking into account","page":8,"pdf":"sccp_o_142.pdf","row_type":"noael_study","study_id":"sccp_o_142_noael_001"} |
| SCCS_vision_codex | NOAEL | =65.7 | % | - | - | Chronic | genotoxicity | {"citation":"Ref.: 15 Comment As the dye content of the test substance is only 65","dose":"At 150 mg/kg bw/day, there was a decrease in body weight gain in male animals (again from week 1, with a terminal mean bodyweight of 93% of control), but no other toxicological effects were reported.","effect":"oxic symptoms. Macroscopic and histological evaluation revealed discoloration of the inner organs. At 150 mg/kg bw/day, there was a decrease in body weight gain in male animals (again from week 1, with a terminal mean bodyweight of 93% of control), but no other toxicological effects were reported. Coloured urine was excreted by animals treated with 150 and 450 mg/kg, throughout the treatment period. Conclusion The dose of 50 mg/kg bw/day was tolerated without any signs of adverse effects and is regarded to be the NOAEL. Ref.: 15 Comment As the dye content of the test substance is only 65.7%, the NOAEL value is re-calculated to be 33 mg/kg/bw/day. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Test Guideline: OECD 471 (1997) Species/strain: Salmonella typhimurium TA98, TA100, TA102, TA1535 and TA1537 Replicates: triplicates in 2 individual experiments both in the presence and absence of S9-mix. Test substan","page":16,"pdf":"sccp_o_142.pdf","row_type":"noael_study","study_id":"sccp_o_142_noael_002"} |
| SCCS_vision_codex | NOAEL | =90 | mg/kg | rat | - | - | developmental toxicity | {"dose":"Conclusion At the high dosage of 180 mg/kg bw/day, C009 caused slight maternal toxicity as indicated by the reduction in body weight gain on GD 9 when compared with controls.","effect":"weight (from 30 to 47%) compared with control mean foetal weight. Conclusion At the high dosage of 180 mg/kg bw/day, C009 caused slight maternal toxicity as indicated by the reduction in body weight gain on GD 9 when compared with controls. As a consequence of the maternal toxicity, a mean reduced foetal weight was observed and a delay in the ossification of some bones was noted at the skeletal examination. Neither embryotoxic nor teratogenic effects of C009 has been found in rats under the study conditions. The NOAEL both for maternal and embryo foetal toxicity was considered to be 90 mg/kg","page":21,"pdf":"sccp_o_142.pdf","row_type":"noael_study","study_id":"sccp_o_142_noael_004"} |
| SCCS_vision_codex | NOAEL | =50 | mg/kg bw/day | rat | oral | 90-day | carcinogenicity | {"dose":"The cleavage of the azo-group may release para-phenylenediamine (PPD) General toxicity The acute median lethal oral dose (LD50) of Basic Brown 16 was reported to be between 2 and 4 g/kg bw.","effect":"ied impurities were detected by HPLC, which were not characterised. Methylbromide is classified by the EU as mutagenic category 3; methylchloride is classified by the EU as carcinogenic category 3 The stability data of Basic Brown 16 in the test solutions and in the marketed product is not reported. The cleavage of the azo-group may release para-phenylenediamine (PPD) General toxicity The acute median lethal oral dose (LD50) of Basic Brown 16 was reported to be between 2 and 4 g/kg bw. In a 90-day rat study, the NOAEL was considered to be 50 mg/kg bw/day, based on decreased body weight gain and some neurotoxic symptoms in both sexes. This value was re-calculated to 33 mg/kg bw/day based on the dye content of the test substance. The NOAEL both for maternal and embryo-foetal toxicity was considered to be 90 mg/kg bw/day. This value was re-calculated to 59 mg/kg bw/day based on the dye content of the test substance.","page":22,"pdf":"sccp_o_142.pdf","row_type":"noael_study","study_id":"sccp_o_142_noael_006"} |
| SCCS_vision_codex | NOAEL | =33 | mg/kg bw/day | rat | oral | 90-day | NOAEL study | {"dose":"The cleavage of the azo-group may release para-phenylenediamine (PPD) General toxicity The acute median lethal oral dose (LD50) of Basic Brown 16 was reported to be between 2 and 4 g/kg bw.","effect":"Brown 16 in the test solutions and in the marketed product is not reported. The cleavage of the azo-group may release para-phenylenediamine (PPD) General toxicity The acute median lethal oral dose (LD50) of Basic Brown 16 was reported to be between 2 and 4 g/kg bw. In a 90-day rat study, the NOAEL was considered to be 50 mg/kg bw/day, based on decreased body weight gain and some neurotoxic symptoms in both sexes. This value was re-calculated to 33 mg/kg bw/day based on the dye content of the test substance. The NOAEL both for maternal and embryo-foetal toxicity was considered to be 90 mg/kg bw/day. This value was re-calculated to 59 mg/kg bw/day based on the dye content of the test substance.","page":22,"pdf":"sccp_o_142.pdf","row_type":"noael_study","study_id":"sccp_o_142_noael_007"} |
| SCCS_vision_codex | NOAEL | =8 | - | - | - | 90-day | NOAEL study | {"dose":"The 90-day NOAEL dose of the batch KS 6024 needs to be corrected according to the dye","effect":"Unlabeled table on page 8: The 90-day NOAEL dose of the batch KS 6024 needs to be corrected according to the dye","page":8,"pdf":"sccp_o_142.pdf","row_type":"noael_study","study_id":"sccp_o_142_noael_008"} |
| SCCS_vision_codex | NOAEL | =3.1 | - | - | - | - | NOAEL study | {"effect":"Unlabeled table on page 8: 3.1.5. Impurities / accompanying contaminants","page":8,"pdf":"sccp_o_142.pdf","row_type":"noael_study","study_id":"sccp_o_142_noael_009"} |
| SCCS_vision_codex | NOAEL | =7 | - | - | - | - | NOAEL study | {"effect":"Unlabeled table on page 8: In addition to the NTBRI (7-Hydroxy-N,N,N-trimethyl-naphthalen-2-aminium chloride)","page":8,"pdf":"sccp_o_142.pdf","row_type":"noael_study","study_id":"sccp_o_142_noael_010"} |
| SCCS_vision_codex | NOAEL | =0.5 | % | - | - | - | NOAEL study | {"effect":"Unlabeled table on page 8: not identified) by HPLC in batch 57861/2, representing about 0.5%.","page":8,"pdf":"sccp_o_142.pdf","row_type":"noael_study","study_id":"sccp_o_142_noael_012"} |
| SCCS_vision_codex | NOAEL | =1.2 | % | - | - | - | NOAEL study | {"effect":"Unlabeled table on page 8: non-identified impurities may be more taking into account that their total content is 1.2%.","page":8,"pdf":"sccp_o_142.pdf","row_type":"noael_study","study_id":"sccp_o_142_noael_013"} |
| SCCS_vision_codex | NOAEL | =6024 | - | - | - | - | NOAEL study | {"effect":"Unlabeled table on page 8: Also, the content of NTBRI in the batch KS 6024 was found much higher than in the batch","page":8,"pdf":"sccp_o_142.pdf","row_type":"noael_study","study_id":"sccp_o_142_noael_014"} |
| SCCS_vision_codex | NOAEL | =89.1 | % | - | - | - | NOAEL study | {"effect":"Unlabeled table on page 8: batch 57861/2 Basic Brown 16 = 89.1% NTBRI = 0.13% (0.13/89.1 = 0.0015)","page":8,"pdf":"sccp_o_142.pdf","row_type":"noael_study","study_id":"sccp_o_142_noael_015"} |
| SCCS_vision_codex | NOAEL | =100 | - | - | - | - | NOAEL study | {"effect":"Unlabeled table on page 8: Water: > 100 g/l at room temperature","page":8,"pdf":"sccp_o_142.pdf","row_type":"noael_study","study_id":"sccp_o_142_noael_018"} |
| SCCS_vision_codex | NOAEL | =10 | - | - | - | - | NOAEL study | {"effect":"Unlabeled table on page 8: Ethanol: 10-100 g/l at room temperature","page":8,"pdf":"sccp_o_142.pdf","row_type":"noael_study","study_id":"sccp_o_142_noael_019"} |
| SCCS_vision_codex | NOAEL | =1.66 | - | - | - | - | NOAEL study | {"effect":"Unlabeled table on page 8: Log Po/w: (calc. Syracuse Vers. 1.66): 0.88","page":8,"pdf":"sccp_o_142.pdf","row_type":"noael_study","study_id":"sccp_o_142_noael_022"} |
| SCCS_vision_codex | NOAEL | =169 | - | - | - | - | NOAEL study | {"effect":"Unlabeled table on page 8: Melting point: 169-175 °C (in SCCNFP/0667/03 it was 160-170 °C-","page":8,"pdf":"sccp_o_142.pdf","row_type":"noael_study","study_id":"sccp_o_142_noael_024"} |
| SCCS_vision_codex | NOAEL | =90 | mg/kg bw/day | rat | - | - | reproductive toxicity | {"dose":"The NOAEL both for maternal and embryo foetal toxicity was considered to be 90 mg/kg bw/day.","effect":"ot of Basic Brown 16. Hence, the SCCS considers that a concern for the potential of Basic Brown 16 (including the new batch VW230921A) to induce gene mutations and chromosomal aberrations remains. 3.3.7. Carcinogenicity SCCS comment As genotoxicity of Basic Brown 16 cannot be excluded, the SCCS considers that the concerns for carcinogenicity cannot be ruled out. 3.3.8. Reproductive toxicity From SCCS/1496/12: “Neither embryotoxic nor teratogenic effects have been found in rats under the study conditions. The NOAEL both for maternal and embryo foetal toxicity was considered to be 90 mg/kg bw/day. As the dye content of the test substance is only 65.7%, the NOAEL value is re-calculated to 59 mg/kg bw/day.” 3.3.9. Toxicokinetics 3.3.9.1. Toxicokinetics in laboratory animals /","page":24,"pdf":"sccs_o_305.pdf","row_type":"noael_study","study_id":"sccs_o_305_noael_003"} |
| SCCS_vision_codex | NOAEL | =0.095 | mg/kg bw | rat | oral | 90-day | dermal absorption | {"dose":"The NOAEL of 33 mg/kg bw/day from the 90-d oral study is adjusted considering a 50% oral absorption factor.","effect":"2 SD (5.15 + 2 x 2.32 = 9.79 μg/cm² is used for calculating the MOS. The NOAEL of 33 mg/kg bw/day from the 90-d oral study is adjusted considering a 50% oral absorption factor. CALCULATION OF THE MARGIN OF SAFETY (……. conditions) (…..% formulation, on head concentration …..%) Absorption through the skin A = 9.79 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 5.68 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.095 mg/kg bw No observed adverse effect level NOAEL = 33 mg/kg bw/d (90-day, oral, rat) Default oral absorption = 50% Bioavailability 50%* = 16.5 mg/kg bw/d","page":25,"pdf":"sccs_o_305.pdf","row_type":"noael_study","study_id":"sccs_o_305_noael_006"} |
| SCCS_vision_codex | NOAEL | =33 | mg/kg bw/d | - | oral | - | irritation | {"dose":"A NOAEL of 33 mg/kg bw/d has been identified in a 90-d oral study, it covers the NOAEL of 59 mg/kg bw/d in the teratogenicity study.","effect":"SCCS/1684/25 Final version Scientific Advice on hair dye ‘Basic Brown 16’ (C009) (CAS No. 26381-41-9, EC No. 247-640-9) – submission V ter. _________________________________________________________________________________________________________________ 26 Margin of Safety adjusted NOAEL/SED = 174.4 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. The Margin of Safety for BASIC BROWN 16 is 174 for the expected use. Conclusion by the Applicant BASIC BROWN 16 is non acutely toxic. It is not irritant for the skin and it is a moderate skin sensitizer. A NOAEL of 33 mg/kg bw/d has been identified in a 90-d oral study, it covers the NOAEL of 59 mg/kg bw/d in the teratogenicity study. This allows the calculation of a sa","page":26,"pdf":"sccs_o_305.pdf","row_type":"noael_study","study_id":"sccs_o_305_noael_008"} |
| SCCS_vision_codex | NOAEL | =59 | mg/kg bw/d | - | oral | - | irritation | {"dose":"A NOAEL of 33 mg/kg bw/d has been identified in a 90-d oral study, it covers the NOAEL of 59 mg/kg bw/d in the teratogenicity study.","effect":"SCCS-rejected applicant NOAEL: _________________________________________________ 26 Margin of Safety adjusted NOAEL/SED = 174.4 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. The Margin of Safety for BASIC BROWN 16 is 174 for the expected use. Conclusion by the Applicant BASIC BROWN 16 is non acutely toxic. It is not irritant for the skin and it is a moderate skin sensitizer. A NOAEL of 33 mg/kg bw/d has been identified in a 90-d oral study, it covers the NOAEL of 59 mg/kg bw/d in the teratogenicity study. This allows the calculation of a safe margin of safety for the expected use as hair dye at 2%. It is noteworthy that the SCCS evaluated a similar substance (BB17) in 2014 and concluded it to be safe for use in non-oxidative hair dye formulations. The same positive effects were limited to bacteria models. Some limitation in the tests in mammalian systems where observed. It was not considered mutagenic in an in vitro micronucleus test, and negative in a micronucleus test","page":26,"pdf":"sccs_o_305.pdf","row_type":"noael_study","study_id":"sccs_o_305_noael_010"} |
UnifiedCodex:SCCNFP:beta.noael_studies 4 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| UnifiedCodex:SCCNFP:beta.noael_studies | dermal absorption | >94 | % | human | dermal | - | dermal absorption | SOURCE_SUBDIR=out_198; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING BASIC BROWN 16 COLIPA n° C9; OPINION_NUMBER=SCCNFP/0668/03; COMMITTEE=SCCNFP; REPORT_DATE=18 March 2003; VALUE_TEXT=>94; DOSE=The study is considered inadequate, because only one dose was tested.; EFFECT=was not different from the control. The study is considered inadequate, because only one dose was tested. Ref. : 12 2.11. Safety evaluation NOT APPLICABLE CALCULATION OF THE MARGIN OF SAFETY (Basic Brown 16) (semipermanent) Based on a usage volume of 35 ml, containing at maximum … % Maximum absorption through the skin A (µg/cm2) = µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = cm2 Dermal absorption per treatment SAS x A x 0.001 = mg Systemic exposure dose (SED) SAS x A x 0.001/60 = mg/kg No observed adverse effect level (mg/kg) NOAEL = mg/kg (species, study) Margin of Safety NOAEL / SED = 2.12. Conclusions Commercial grade dye of different batches have been used for various tests, but purity (>94%) of the dye has been described only in one case. The impurities in the dye should be described. The test substance is an azo-dye, therefore, free aromatic amine content in the dye (in all batches) is required. The dye formulation contains approximately 15 % sugar and 6% inorganic salts. A complete description of the sugar and salts is r; CITATION=Ref. : 12 2; CITATION_NUMBERS=[12,2]; REFERENCE=Ref. : 12 2; DETAILS_JSON={"cas_number":"26381-41-9","citation":"Ref. : 12 2","dose":"The study is considered inadequate, because only one dose was tested.","duration":"","effect":"was not different from the control. The study is considered inadequate, because only one dose was tested. Ref. : 12 2.11. Safety evaluation NOT APPLICABLE CALCULATION OF THE MARGIN OF SAFETY (Basic Brown 16) (semipermanent) Based on a usage volume of 35 ml, containing at maximum … % Maximum absorption through the skin A (µg/cm2) = µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = cm2 Dermal absorption per treatment SAS x A x 0.001 = mg Systemic exposure dose (SED) SAS x A x 0.001/60 = mg/kg No observed adverse effect level (mg/kg) NOAEL = mg/kg (species, study) Margin of Safety NOAEL / SED = 2.12. Conclusions Commercial grade dye of different batches have been used for various tests, but purity (>94%) of the dye has been described only in one case. The impurities in the dye should be described. The test substance is an azo-dye, therefore, free aromatic amine content in the dye (in all batches) is required. The dye formulation contains approximately 15 % sugar and 6% inorganic salts. A complete description of the sugar and salts is r","endpoint":"dermal absorption","ingredient":"codes","loael_value":"","noael_unit":"%","noael_value":">94","page":13,"route":"dermal","species":"human","study_id":"out_198_noael_002"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | dermal absorption | >94 | % | human | dermal | - | dermal absorption | SOURCE_SUBDIR=out_198; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING BASIC BROWN 16 COLIPA n° C9; OPINION_NUMBER=SCCNFP/0668/03; COMMITTEE=SCCNFP; REPORT_DATE=18 March 2003; VALUE_TEXT=>94; DOSE=tudy is considered inadequate, because only one dose was tested.; EFFECT=tudy is considered inadequate, because only one dose was tested. Ref. : 12 2.11. Safety evaluation NOT APPLICABLE CALCULATION OF THE MARGIN OF SAFETY (Basic Brown 16) (semipermanent) Based on a usage volume of 35 ml, containing at maximum … % Maximum absorption through the skin A (µg/cm2) = µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = cm2 Dermal absorption per treatment SAS x A x 0.001 = mg Systemic exposure dose (SED) SAS x A x 0.001/60 = mg/kg No observed adverse effect level (mg/kg) NOAEL = mg/kg (species, study) Margin of Safety NOAEL / SED = 2.12. Conclusions Commercial grade dye of different batches have been used for various tests, but purity (>94%) of the dye has been described only in one case. The impurities in the dye should be described. The test substance is an azo-dye, therefore, free aromatic amine content in the dye (in all batches) is required. The dye formulation contains approximately 15 % sugar and 6% inorganic salts. A complete description of the sugar and salts is required. Follo; CITATION=Ref. : 12 2; CITATION_NUMBERS=[12,2]; REFERENCE=Ref. : 12 2; DETAILS_JSON={"cas_number":"26381-41-9","citation":"Ref. : 12 2","dose":"tudy is considered inadequate, because only one dose was tested.","duration":"","effect":"tudy is considered inadequate, because only one dose was tested. Ref. : 12 2.11. Safety evaluation NOT APPLICABLE CALCULATION OF THE MARGIN OF SAFETY (Basic Brown 16) (semipermanent) Based on a usage volume of 35 ml, containing at maximum … % Maximum absorption through the skin A (µg/cm2) = µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = cm2 Dermal absorption per treatment SAS x A x 0.001 = mg Systemic exposure dose (SED) SAS x A x 0.001/60 = mg/kg No observed adverse effect level (mg/kg) NOAEL = mg/kg (species, study) Margin of Safety NOAEL / SED = 2.12. Conclusions Commercial grade dye of different batches have been used for various tests, but purity (>94%) of the dye has been described only in one case. The impurities in the dye should be described. The test substance is an azo-dye, therefore, free aromatic amine content in the dye (in all batches) is required. The dye formulation contains approximately 15 % sugar and 6% inorganic salts. A complete description of the sugar and salts is required. Follo","endpoint":"dermal absorption","ingredient":"codes","loael_value":"","noael_unit":"%","noael_value":">94","page":13,"route":"dermal","species":"human","study_id":"out_198_noael_003"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | dermal absorption | >94 | % | human | dermal | - | dermal absorption | SOURCE_SUBDIR=out_198; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING BASIC BROWN 16 COLIPA n° C9; OPINION_NUMBER=SCCNFP/0668/03; COMMITTEE=SCCNFP; REPORT_DATE=18 March 2003; VALUE_TEXT=>94; DOSE=Safety evaluation NOT APPLICABLE CALCULATION OF THE MARGIN OF SAFETY (Basic Brown 16) (semipermanent) Based on a usage volume of 35 ml, containing at maximum … % Maximum absorption through the skin A (µg/cm2) = µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = cm2 Dermal absorption per treatment SAS x A x 0.001 = mg Syste...; EFFECT=dose was tested. Ref. : 12 2.11. Safety evaluation NOT APPLICABLE CALCULATION OF THE MARGIN OF SAFETY (Basic Brown 16) (semipermanent) Based on a usage volume of 35 ml, containing at maximum … % Maximum absorption through the skin A (µg/cm2) = µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = cm2 Dermal absorption per treatment SAS x A x 0.001 = mg Systemic exposure dose (SED) SAS x A x 0.001/60 = mg/kg No observed adverse effect level (mg/kg) NOAEL = mg/kg (species, study) Margin of Safety NOAEL / SED = 2.12. Conclusions Commercial grade dye of different batches have been used for various tests, but purity (>94%) of the dye has been described only in one case. The impurities in the dye should be described. The test substance is an azo-dye, therefore, free aromatic amine content in the dye (in all batches) is required. The dye formulation contains approximately 15 % sugar and 6% inorganic salts. A complete description of the sugar and salts is required. Following physical properties are also required: dens; CITATION=Ref. : 12 2; CITATION_NUMBERS=[12,2]; REFERENCE=Ref. : 12 2; DETAILS_JSON={"cas_number":"26381-41-9","citation":"Ref. : 12 2","dose":"Safety evaluation NOT APPLICABLE CALCULATION OF THE MARGIN OF SAFETY (Basic Brown 16) (semipermanent) Based on a usage volume of 35 ml, containing at maximum … % Maximum absorption through the skin A (µg/cm2) = µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = cm2 Dermal absorption per treatment SAS x A x 0.001 = mg Syste...","duration":"","effect":"dose was tested. Ref. : 12 2.11. Safety evaluation NOT APPLICABLE CALCULATION OF THE MARGIN OF SAFETY (Basic Brown 16) (semipermanent) Based on a usage volume of 35 ml, containing at maximum … % Maximum absorption through the skin A (µg/cm2) = µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = cm2 Dermal absorption per treatment SAS x A x 0.001 = mg Systemic exposure dose (SED) SAS x A x 0.001/60 = mg/kg No observed adverse effect level (mg/kg) NOAEL = mg/kg (species, study) Margin of Safety NOAEL / SED = 2.12. Conclusions Commercial grade dye of different batches have been used for various tests, but purity (>94%) of the dye has been described only in one case. The impurities in the dye should be described. The test substance is an azo-dye, therefore, free aromatic amine content in the dye (in all batches) is required. The dye formulation contains approximately 15 % sugar and 6% inorganic salts. A complete description of the sugar and salts is required. Following physical properties are also required: dens","endpoint":"dermal absorption","ingredient":"codes","loael_value":"","noael_unit":"%","noael_value":">94","page":13,"route":"dermal","species":"human","study_id":"out_198_noael_004"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | repeated dose toxicity | 50 | mg/kg | rabbit | dermal | Sub-chronic | repeated dose toxicity | SOURCE_SUBDIR=out_198; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING BASIC BROWN 16 COLIPA n° C9; OPINION_NUMBER=SCCNFP/0668/03; COMMITTEE=SCCNFP; REPORT_DATE=18 March 2003; VALUE_TEXT=50; DOSE=Coloured urine was excreted by animals treated with 150 and 450 mg/kg, throughout the treatment period.; EFFECT=_____ 7 neurotoxic symptoms. Macroscopic and histological evaluation revealed discoloration of the inner organs. At 150mg/kg bw there was a decrease in body weight gain in male animals (again from week 1, with a terminal mean bodyweight of 93% of control), but no other toxicological effects were reported. Coloured urine was excreted by animals treated with 150 and 450 mg/kg, throughout the treatment period. The dose of 50mg/kg body weight was tolerated without any signs of adverse effects and is regarded to be the NOAEL. Ref. : 7 2.3.8. Sub-chronic dermal toxicity No data 2.3.9. Sub-chronic inhalation toxicity No data 2.3.10. Chronic toxicity No data 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Test on undiluted material Guideline : / Species : New Zealand white rabbit Route : skin Group sizes : 3 male and 3 female Material : undiluted Basic Brown 16 Batch no : not stated Dose : 0.5 g/in2 GLP : not in compliance Undiluted Basic Brown 16 was applied at a dose of 0.5 g/in2 to the backs of 3 rabbits of each sex with shorn; CITATION=Ref. : 7 2; CITATION_NUMBERS=[7,2]; REFERENCE=Ref. : 7 2; DETAILS_JSON={"cas_number":"26381-41-9","citation":"Ref. : 7 2","dose":"Coloured urine was excreted by animals treated with 150 and 450 mg/kg, throughout the treatment period.","duration":"Sub-chronic","effect":"_____ 7 neurotoxic symptoms. Macroscopic and histological evaluation revealed discoloration of the inner organs. At 150mg/kg bw there was a decrease in body weight gain in male animals (again from week 1, with a terminal mean bodyweight of 93% of control), but no other toxicological effects were reported. Coloured urine was excreted by animals treated with 150 and 450 mg/kg, throughout the treatment period. The dose of 50mg/kg body weight was tolerated without any signs of adverse effects and is regarded to be the NOAEL. Ref. : 7 2.3.8. Sub-chronic dermal toxicity No data 2.3.9. Sub-chronic inhalation toxicity No data 2.3.10. Chronic toxicity No data 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Test on undiluted material Guideline : / Species : New Zealand white rabbit Route : skin Group sizes : 3 male and 3 female Material : undiluted Basic Brown 16 Batch no : not stated Dose : 0.5 g/in2 GLP : not in compliance Undiluted Basic Brown 16 was applied at a dose of 0.5 g/in2 to the backs of 3 rabbits of each sex with shorn","endpoint":"repeated dose toxicity","ingredient":"codes","loael_value":"","noael_unit":"mg/kg","noael_value":"50","page":7,"route":"dermal","species":"rabbit","study_id":"out_198_noael_001"} |
UnifiedCodex:SCCS_SHADOW:beta.noael_studies 24 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 50 | % | - | - | 90-day | - | SOURCE_SUBDIR=sccp_o_142; REPORT_TITLE=OPINION ON Basic Brown 16 COLIPA n° C9; OPINION_NUMBER=SCCP/1165/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=30 September 2008; VALUE_TEXT=50-60; DOSE=The 90-day NOAEL dose of the batch KS 6024 needs to be corrected according to the dye content.; EFFECT=nformation it can be concluded that the former not fully described batch is representative and the specification of the contained dye is quite similar to the fully characterized batch 57861/2. Ref: 1 Comment The Purity by NMR = 65.7% (w/w) stated in the Summary submission III for the batch KS 6024 is contradictory to the data reported in the specific analytical file (ref. 5), according to which the content is 50-60% by UV/VIS analysis using the extinction coefficients calculated for the batch 57861/2. The 90-day NOAEL dose of the batch KS 6024 needs to be corrected according to the dye content. 3.1.5. Impurities / accompanying contaminants In addition to the NTBRI (7-Hydroxy-N,N,N-trimethyl-naphthalen-2-aminium chloride) mentioned in the previous section 3.1.4, at least 10 additional impurities were detected (but not identified) by HPLC in batch 57861/2, representing about 0.5%. Comparable HPLC data are not provided for the other batches, but the number of additional non-identified impurities may be more taking into account; CITATION=Ref: 1 Comment The Purity by NMR = 65; CITATION_NUMBERS=[1,65]; REFERENCE=Ref: 1 Comment The Purity by NMR = 65; DETAILS_JSON={"cas_number":"26381-41-9","citation":"Ref: 1 Comment The Purity by NMR = 65","dose":"The 90-day NOAEL dose of the batch KS 6024 needs to be corrected according to the dye content.","duration":"90-day","effect":"nformation it can be concluded that the former not fully described batch is representative and the specification of the contained dye is quite similar to the fully characterized batch 57861/2. Ref: 1 Comment The Purity by NMR = 65.7% (w/w) stated in the Summary submission III for the batch KS 6024 is contradictory to the data reported in the specific analytical file (ref. 5), according to which the content is 50-60% by UV/VIS analysis using the extinction coefficients calculated for the batch 57861/2. The 90-day NOAEL dose of the batch KS 6024 needs to be corrected according to the dye content. 3.1.5. Impurities / accompanying contaminants In addition to the NTBRI (7-Hydroxy-N,N,N-trimethyl-naphthalen-2-aminium chloride) mentioned in the previous section 3.1.4, at least 10 additional impurities were detected (but not identified) by HPLC in batch 57861/2, representing about 0.5%. Comparable HPLC data are not provided for the other batches, but the number of additional non-identified impurities may be more taking into account","endpoint":"","ingredient":"Basic Brown 16","loael_value":"","noael_unit":"%","noael_value":"50-60","page":8,"route":"","species":"","study_id":"sccp_o_142_noael_001"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 65.7 | % | human | - | - | - | SOURCE_SUBDIR=sccp_o_142; REPORT_TITLE=OPINION ON Basic Brown 16 COLIPA n° C9; OPINION_NUMBER=SCCP/1165/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=30 September 2008; VALUE_TEXT=65.7; DOSE=16 Comment As the dye content of the test substance is only 65.7%, the NOAEL value is re-calculated to 59 mg/kg bw/day.; EFFECT=SCCP/1165/08 Opinion on Basic Brown 16 22 bw/day. Ref.: 16 Comment As the dye content of the test substance is only 65.7%, the NOAEL value is re-calculated to 59 mg/kg bw/day. 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 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 Not applicable 3.3.14. Discussion Physico-chemical properties Basic Brown 16 is used as a direct dye for hair colouring products without mixing with an oxidising agent (e.g. hydrogen peroxid; CITATION=Ref.: 16 Comment As the dye content of the test substance is only 65; CITATION_NUMBERS=[16,65]; REFERENCE=Ref.: 16 Comment As the dye content of the test substance is only 65; DETAILS_JSON={"cas_number":"26381-41-9","citation":"Ref.: 16 Comment As the dye content of the test substance is only 65","dose":"16 Comment As the dye content of the test substance is only 65.7%, the NOAEL value is re-calculated to 59 mg/kg bw/day.","duration":"","effect":"SCCP/1165/08 Opinion on Basic Brown 16 22 bw/day. Ref.: 16 Comment As the dye content of the test substance is only 65.7%, the NOAEL value is re-calculated to 59 mg/kg bw/day. 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 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 Not applicable 3.3.14. Discussion Physico-chemical properties Basic Brown 16 is used as a direct dye for hair colouring products without mixing with an oxidising agent (e.g. hydrogen peroxid","endpoint":"","ingredient":"Basic Brown 16","loael_value":"","noael_unit":"%","noael_value":"65.7","page":22,"route":"","species":"human","study_id":"sccp_o_142_noael_005"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 33 | mg/kg bw/day | rat | oral | 90-day | - | SOURCE_SUBDIR=sccp_o_142; REPORT_TITLE=OPINION ON Basic Brown 16 COLIPA n° C9; OPINION_NUMBER=SCCP/1165/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=30 September 2008; VALUE_TEXT=33; DOSE=The cleavage of the azo-group may release para-phenylenediamine (PPD) General toxicity The acute median lethal oral dose (LD50) of Basic Brown 16 was reported to be between 2 and 4 g/kg bw.; EFFECT=Brown 16 in the test solutions and in the marketed product is not reported. The cleavage of the azo-group may release para-phenylenediamine (PPD) General toxicity The acute median lethal oral dose (LD50) of Basic Brown 16 was reported to be between 2 and 4 g/kg bw. In a 90-day rat study, the NOAEL was considered to be 50 mg/kg bw/day, based on decreased body weight gain and some neurotoxic symptoms in both sexes. This value was re-calculated to 33 mg/kg bw/day based on the dye content of the test substance. The NOAEL both for maternal and embryo-foetal toxicity was considered to be 90 mg/kg bw/day. This value was re-calculated to 59 mg/kg bw/day based on the dye content of the test substance.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"26381-41-9","citation":"","dose":"The cleavage of the azo-group may release para-phenylenediamine (PPD) General toxicity The acute median lethal oral dose (LD50) of Basic Brown 16 was reported to be between 2 and 4 g/kg bw.","duration":"90-day","effect":"Brown 16 in the test solutions and in the marketed product is not reported. The cleavage of the azo-group may release para-phenylenediamine (PPD) General toxicity The acute median lethal oral dose (LD50) of Basic Brown 16 was reported to be between 2 and 4 g/kg bw. In a 90-day rat study, the NOAEL was considered to be 50 mg/kg bw/day, based on decreased body weight gain and some neurotoxic symptoms in both sexes. This value was re-calculated to 33 mg/kg bw/day based on the dye content of the test substance. The NOAEL both for maternal and embryo-foetal toxicity was considered to be 90 mg/kg bw/day. This value was re-calculated to 59 mg/kg bw/day based on the dye content of the test substance.","endpoint":"","ingredient":"Basic Brown 16","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"33","page":22,"route":"oral","species":"rat","study_id":"sccp_o_142_noael_007"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 8 | - | - | - | 90-day | - | SOURCE_SUBDIR=sccp_o_142; REPORT_TITLE=OPINION ON Basic Brown 16 COLIPA n° C9; OPINION_NUMBER=SCCP/1165/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=30 September 2008; VALUE_TEXT=unclear:Unlabeled table on page 8: The 90-day NOAEL dose of the batch KS 6024 needs to be corrected according to the dye; DOSE=The 90-day NOAEL dose of the batch KS 6024 needs to be corrected according to the dye; EFFECT=Unlabeled table on page 8: The 90-day NOAEL dose of the batch KS 6024 needs to be corrected according to the dye; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"26381-41-9","citation":"","dose":"The 90-day NOAEL dose of the batch KS 6024 needs to be corrected according to the dye","duration":"90-day","effect":"Unlabeled table on page 8: The 90-day NOAEL dose of the batch KS 6024 needs to be corrected according to the dye","endpoint":"","ingredient":"Basic Brown 16","loael_value":"","noael_unit":"","noael_value":"unclear:Unlabeled table on page 8: The 90-day NOAEL dose of the batch KS 6024 needs to be corrected according to the dye","page":8,"route":"","species":"","study_id":"sccp_o_142_noael_008"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 3.1 | - | - | - | - | - | SOURCE_SUBDIR=sccp_o_142; REPORT_TITLE=OPINION ON Basic Brown 16 COLIPA n° C9; OPINION_NUMBER=SCCP/1165/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=30 September 2008; VALUE_TEXT=3.1.5. Impurities / accompanying contaminants; EFFECT=Unlabeled table on page 8: 3.1.5. Impurities / accompanying contaminants; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"26381-41-9","citation":"","dose":"","duration":"","effect":"Unlabeled table on page 8: 3.1.5. Impurities / accompanying contaminants","endpoint":"","ingredient":"Basic Brown 16","loael_value":"","noael_unit":"","noael_value":"3.1.5. Impurities / accompanying contaminants","page":8,"route":"","species":"","study_id":"sccp_o_142_noael_009"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 7 | - | - | - | - | - | SOURCE_SUBDIR=sccp_o_142; REPORT_TITLE=OPINION ON Basic Brown 16 COLIPA n° C9; OPINION_NUMBER=SCCP/1165/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=30 September 2008; VALUE_TEXT=In addition to the NTBRI (7-Hydroxy-N,N,N-trimethyl-naphthalen-2-aminium chloride); EFFECT=Unlabeled table on page 8: In addition to the NTBRI (7-Hydroxy-N,N,N-trimethyl-naphthalen-2-aminium chloride); CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"26381-41-9","citation":"","dose":"","duration":"","effect":"Unlabeled table on page 8: In addition to the NTBRI (7-Hydroxy-N,N,N-trimethyl-naphthalen-2-aminium chloride)","endpoint":"","ingredient":"Basic Brown 16","loael_value":"","noael_unit":"","noael_value":"In addition to the NTBRI (7-Hydroxy-N,N,N-trimethyl-naphthalen-2-aminium chloride)","page":8,"route":"","species":"","study_id":"sccp_o_142_noael_010"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 3.1 | - | - | - | - | - | SOURCE_SUBDIR=sccp_o_142; REPORT_TITLE=OPINION ON Basic Brown 16 COLIPA n° C9; OPINION_NUMBER=SCCP/1165/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=30 September 2008; VALUE_TEXT=mentioned in the previous section 3.1.4, at least 10 additional impurities were detected (but; EFFECT=Unlabeled table on page 8: mentioned in the previous section 3.1.4, at least 10 additional impurities were detected (but; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"26381-41-9","citation":"","dose":"","duration":"","effect":"Unlabeled table on page 8: mentioned in the previous section 3.1.4, at least 10 additional impurities were detected (but","endpoint":"","ingredient":"Basic Brown 16","loael_value":"","noael_unit":"","noael_value":"mentioned in the previous section 3.1.4, at least 10 additional impurities were detected (but","page":8,"route":"","species":"","study_id":"sccp_o_142_noael_011"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 0.5 | % | - | - | - | - | SOURCE_SUBDIR=sccp_o_142; REPORT_TITLE=OPINION ON Basic Brown 16 COLIPA n° C9; OPINION_NUMBER=SCCP/1165/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=30 September 2008; VALUE_TEXT=0.5; EFFECT=Unlabeled table on page 8: not identified) by HPLC in batch 57861/2, representing about 0.5%.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"26381-41-9","citation":"","dose":"","duration":"","effect":"Unlabeled table on page 8: not identified) by HPLC in batch 57861/2, representing about 0.5%.","endpoint":"","ingredient":"Basic Brown 16","loael_value":"","noael_unit":"%","noael_value":"0.5","page":8,"route":"","species":"","study_id":"sccp_o_142_noael_012"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 1.2 | % | - | - | - | - | SOURCE_SUBDIR=sccp_o_142; REPORT_TITLE=OPINION ON Basic Brown 16 COLIPA n° C9; OPINION_NUMBER=SCCP/1165/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=30 September 2008; VALUE_TEXT=1.2; EFFECT=Unlabeled table on page 8: non-identified impurities may be more taking into account that their total content is 1.2%.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"26381-41-9","citation":"","dose":"","duration":"","effect":"Unlabeled table on page 8: non-identified impurities may be more taking into account that their total content is 1.2%.","endpoint":"","ingredient":"Basic Brown 16","loael_value":"","noael_unit":"%","noael_value":"1.2","page":8,"route":"","species":"","study_id":"sccp_o_142_noael_013"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 6024 | - | - | - | - | - | SOURCE_SUBDIR=sccp_o_142; REPORT_TITLE=OPINION ON Basic Brown 16 COLIPA n° C9; OPINION_NUMBER=SCCP/1165/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=30 September 2008; VALUE_TEXT=Also, the content of NTBRI in the batch KS 6024 was found much higher than in the batch; EFFECT=Unlabeled table on page 8: Also, the content of NTBRI in the batch KS 6024 was found much higher than in the batch; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"26381-41-9","citation":"","dose":"","duration":"","effect":"Unlabeled table on page 8: Also, the content of NTBRI in the batch KS 6024 was found much higher than in the batch","endpoint":"","ingredient":"Basic Brown 16","loael_value":"","noael_unit":"","noael_value":"Also, the content of NTBRI in the batch KS 6024 was found much higher than in the batch","page":8,"route":"","species":"","study_id":"sccp_o_142_noael_014"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | =89.1 | % | - | - | - | - | SOURCE_SUBDIR=sccp_o_142; REPORT_TITLE=OPINION ON Basic Brown 16 COLIPA n° C9; OPINION_NUMBER=SCCP/1165/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=30 September 2008; VALUE_TEXT== 89.1; EFFECT=Unlabeled table on page 8: batch 57861/2 Basic Brown 16 = 89.1% NTBRI = 0.13% (0.13/89.1 = 0.0015); CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"26381-41-9","citation":"","dose":"","duration":"","effect":"Unlabeled table on page 8: batch 57861/2 Basic Brown 16 = 89.1% NTBRI = 0.13% (0.13/89.1 = 0.0015)","endpoint":"","ingredient":"Basic Brown 16","loael_value":"","noael_unit":"%","noael_value":"= 89.1","page":8,"route":"","species":"","study_id":"sccp_o_142_noael_015"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | =50 | % | - | - | - | - | SOURCE_SUBDIR=sccp_o_142; REPORT_TITLE=OPINION ON Basic Brown 16 COLIPA n° C9; OPINION_NUMBER=SCCP/1165/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=30 September 2008; VALUE_TEXT== 50-60; EFFECT=Unlabeled table on page 8: batch KS 6024 Basic Brown 16 = 50-60% NTBRI = 0.90% (0.90/60.0 = 0.0150); CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"26381-41-9","citation":"","dose":"","duration":"","effect":"Unlabeled table on page 8: batch KS 6024 Basic Brown 16 = 50-60% NTBRI = 0.90% (0.90/60.0 = 0.0150)","endpoint":"","ingredient":"Basic Brown 16","loael_value":"","noael_unit":"%","noael_value":"= 50-60","page":8,"route":"","species":"","study_id":"sccp_o_142_noael_016"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 3.1 | - | - | - | - | - | SOURCE_SUBDIR=sccp_o_142; REPORT_TITLE=OPINION ON Basic Brown 16 COLIPA n° C9; OPINION_NUMBER=SCCP/1165/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=30 September 2008; VALUE_TEXT=3.1.6. Solubility; EFFECT=Unlabeled table on page 8: 3.1.6. Solubility; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"26381-41-9","citation":"","dose":"","duration":"","effect":"Unlabeled table on page 8: 3.1.6. Solubility","endpoint":"","ingredient":"Basic Brown 16","loael_value":"","noael_unit":"","noael_value":"3.1.6. Solubility","page":8,"route":"","species":"","study_id":"sccp_o_142_noael_017"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | >100 | - | - | - | - | - | SOURCE_SUBDIR=sccp_o_142; REPORT_TITLE=OPINION ON Basic Brown 16 COLIPA n° C9; OPINION_NUMBER=SCCP/1165/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=30 September 2008; VALUE_TEXT=Water: > 100 g/l at room temperature; EFFECT=Unlabeled table on page 8: Water: > 100 g/l at room temperature; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"26381-41-9","citation":"","dose":"","duration":"","effect":"Unlabeled table on page 8: Water: > 100 g/l at room temperature","endpoint":"","ingredient":"Basic Brown 16","loael_value":"","noael_unit":"","noael_value":"Water: > 100 g/l at room temperature","page":8,"route":"","species":"","study_id":"sccp_o_142_noael_018"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 10 | - | - | - | - | - | SOURCE_SUBDIR=sccp_o_142; REPORT_TITLE=OPINION ON Basic Brown 16 COLIPA n° C9; OPINION_NUMBER=SCCP/1165/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=30 September 2008; VALUE_TEXT=Ethanol: 10-100 g/l at room temperature; EFFECT=Unlabeled table on page 8: Ethanol: 10-100 g/l at room temperature; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"26381-41-9","citation":"","dose":"","duration":"","effect":"Unlabeled table on page 8: Ethanol: 10-100 g/l at room temperature","endpoint":"","ingredient":"Basic Brown 16","loael_value":"","noael_unit":"","noael_value":"Ethanol: 10-100 g/l at room temperature","page":8,"route":"","species":"","study_id":"sccp_o_142_noael_019"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 50 | - | - | - | - | - | SOURCE_SUBDIR=sccp_o_142; REPORT_TITLE=OPINION ON Basic Brown 16 COLIPA n° C9; OPINION_NUMBER=SCCP/1165/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=30 September 2008; VALUE_TEXT=DMSO: 50-200 g/l at room temperature; EFFECT=Unlabeled table on page 8: DMSO: 50-200 g/l at room temperature; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"26381-41-9","citation":"","dose":"","duration":"","effect":"Unlabeled table on page 8: DMSO: 50-200 g/l at room temperature","endpoint":"","ingredient":"Basic Brown 16","loael_value":"","noael_unit":"","noael_value":"DMSO: 50-200 g/l at room temperature","page":8,"route":"","species":"","study_id":"sccp_o_142_noael_020"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 3.1 | - | - | - | - | - | SOURCE_SUBDIR=sccp_o_142; REPORT_TITLE=OPINION ON Basic Brown 16 COLIPA n° C9; OPINION_NUMBER=SCCP/1165/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=30 September 2008; VALUE_TEXT=3.1.7. Partition coefficient (Log P ) ow; EFFECT=Unlabeled table on page 8: 3.1.7. Partition coefficient (Log P ) ow; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"26381-41-9","citation":"","dose":"","duration":"","effect":"Unlabeled table on page 8: 3.1.7. Partition coefficient (Log P ) ow","endpoint":"","ingredient":"Basic Brown 16","loael_value":"","noael_unit":"","noael_value":"3.1.7. Partition coefficient (Log P ) ow","page":8,"route":"","species":"","study_id":"sccp_o_142_noael_021"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 1.66 | - | - | - | - | - | SOURCE_SUBDIR=sccp_o_142; REPORT_TITLE=OPINION ON Basic Brown 16 COLIPA n° C9; OPINION_NUMBER=SCCP/1165/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=30 September 2008; VALUE_TEXT=Log Po/w: (calc. Syracuse Vers. 1.66): 0.88; EFFECT=Unlabeled table on page 8: Log Po/w: (calc. Syracuse Vers. 1.66): 0.88; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"26381-41-9","citation":"","dose":"","duration":"","effect":"Unlabeled table on page 8: Log Po/w: (calc. Syracuse Vers. 1.66): 0.88","endpoint":"","ingredient":"Basic Brown 16","loael_value":"","noael_unit":"","noael_value":"Log Po/w: (calc. Syracuse Vers. 1.66): 0.88","page":8,"route":"","species":"","study_id":"sccp_o_142_noael_022"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 3.1 | - | - | - | - | - | SOURCE_SUBDIR=sccp_o_142; REPORT_TITLE=OPINION ON Basic Brown 16 COLIPA n° C9; OPINION_NUMBER=SCCP/1165/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=30 September 2008; VALUE_TEXT=3.1.8. Additional physical and chemical specifications; EFFECT=Unlabeled table on page 8: 3.1.8. Additional physical and chemical specifications; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"26381-41-9","citation":"","dose":"","duration":"","effect":"Unlabeled table on page 8: 3.1.8. Additional physical and chemical specifications","endpoint":"","ingredient":"Basic Brown 16","loael_value":"","noael_unit":"","noael_value":"3.1.8. Additional physical and chemical specifications","page":8,"route":"","species":"","study_id":"sccp_o_142_noael_023"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 169 | - | - | - | - | - | SOURCE_SUBDIR=sccp_o_142; REPORT_TITLE=OPINION ON Basic Brown 16 COLIPA n° C9; OPINION_NUMBER=SCCP/1165/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=30 September 2008; VALUE_TEXT=Melting point: 169-175 °C (in SCCNFP/0667/03 it was 160-170 °C-; EFFECT=Unlabeled table on page 8: Melting point: 169-175 °C (in SCCNFP/0667/03 it was 160-170 °C-; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"26381-41-9","citation":"","dose":"","duration":"","effect":"Unlabeled table on page 8: Melting point: 169-175 °C (in SCCNFP/0667/03 it was 160-170 °C-","endpoint":"","ingredient":"Basic Brown 16","loael_value":"","noael_unit":"","noael_value":"Melting point: 169-175 °C (in SCCNFP/0667/03 it was 160-170 °C-","page":8,"route":"","species":"","study_id":"sccp_o_142_noael_024"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | carcinogenicity | 50 | mg/kg bw/day | rat | oral | 90-day | carcinogenicity | SOURCE_SUBDIR=sccp_o_142; REPORT_TITLE=OPINION ON Basic Brown 16 COLIPA n° C9; OPINION_NUMBER=SCCP/1165/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=30 September 2008; VALUE_TEXT=50; DOSE=The cleavage of the azo-group may release para-phenylenediamine (PPD) General toxicity The acute median lethal oral dose (LD50) of Basic Brown 16 was reported to be between 2 and 4 g/kg bw.; EFFECT=ied impurities were detected by HPLC, which were not characterised. Methylbromide is classified by the EU as mutagenic category 3; methylchloride is classified by the EU as carcinogenic category 3 The stability data of Basic Brown 16 in the test solutions and in the marketed product is not reported. The cleavage of the azo-group may release para-phenylenediamine (PPD) General toxicity The acute median lethal oral dose (LD50) of Basic Brown 16 was reported to be between 2 and 4 g/kg bw. In a 90-day rat study, the NOAEL was considered to be 50 mg/kg bw/day, based on decreased body weight gain and some neurotoxic symptoms in both sexes. This value was re-calculated to 33 mg/kg bw/day based on the dye content of the test substance. The NOAEL both for maternal and embryo-foetal toxicity was considered to be 90 mg/kg bw/day. This value was re-calculated to 59 mg/kg bw/day based on the dye content of the test substance.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"26381-41-9","citation":"","dose":"The cleavage of the azo-group may release para-phenylenediamine (PPD) General toxicity The acute median lethal oral dose (LD50) of Basic Brown 16 was reported to be between 2 and 4 g/kg bw.","duration":"90-day","effect":"ied impurities were detected by HPLC, which were not characterised. Methylbromide is classified by the EU as mutagenic category 3; methylchloride is classified by the EU as carcinogenic category 3 The stability data of Basic Brown 16 in the test solutions and in the marketed product is not reported. The cleavage of the azo-group may release para-phenylenediamine (PPD) General toxicity The acute median lethal oral dose (LD50) of Basic Brown 16 was reported to be between 2 and 4 g/kg bw. In a 90-day rat study, the NOAEL was considered to be 50 mg/kg bw/day, based on decreased body weight gain and some neurotoxic symptoms in both sexes. This value was re-calculated to 33 mg/kg bw/day based on the dye content of the test substance. The NOAEL both for maternal and embryo-foetal toxicity was considered to be 90 mg/kg bw/day. This value was re-calculated to 59 mg/kg bw/day based on the dye content of the test substance.","endpoint":"carcinogenicity","ingredient":"Basic Brown 16","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"50","page":22,"route":"oral","species":"rat","study_id":"sccp_o_142_noael_006"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 90 | mg/kg | rat | - | - | developmental toxicity | SOURCE_SUBDIR=sccp_o_142; REPORT_TITLE=OPINION ON Basic Brown 16 COLIPA n° C9; OPINION_NUMBER=SCCP/1165/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=30 September 2008; VALUE_TEXT=90; DOSE=Conclusion At the high dosage of 180 mg/kg bw/day, C009 caused slight maternal toxicity as indicated by the reduction in body weight gain on GD 9 when compared with controls.; EFFECT=weight (from 30 to 47%) compared with control mean foetal weight. Conclusion At the high dosage of 180 mg/kg bw/day, C009 caused slight maternal toxicity as indicated by the reduction in body weight gain on GD 9 when compared with controls. As a consequence of the maternal toxicity, a mean reduced foetal weight was observed and a delay in the ossification of some bones was noted at the skeletal examination. Neither embryotoxic nor teratogenic effects of C009 has been found in rats under the study conditions. The NOAEL both for maternal and embryo foetal toxicity was considered to be 90 mg/kg; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"26381-41-9","citation":"","dose":"Conclusion At the high dosage of 180 mg/kg bw/day, C009 caused slight maternal toxicity as indicated by the reduction in body weight gain on GD 9 when compared with controls.","duration":"","effect":"weight (from 30 to 47%) compared with control mean foetal weight. Conclusion At the high dosage of 180 mg/kg bw/day, C009 caused slight maternal toxicity as indicated by the reduction in body weight gain on GD 9 when compared with controls. As a consequence of the maternal toxicity, a mean reduced foetal weight was observed and a delay in the ossification of some bones was noted at the skeletal examination. Neither embryotoxic nor teratogenic effects of C009 has been found in rats under the study conditions. The NOAEL both for maternal and embryo foetal toxicity was considered to be 90 mg/kg","endpoint":"developmental toxicity","ingredient":"Basic Brown 16","loael_value":"","noael_unit":"mg/kg","noael_value":"90","page":21,"route":"","species":"rat","study_id":"sccp_o_142_noael_004"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | genotoxicity | 65.7 | % | - | - | Chronic | genotoxicity | SOURCE_SUBDIR=sccp_o_142; REPORT_TITLE=OPINION ON Basic Brown 16 COLIPA n° C9; OPINION_NUMBER=SCCP/1165/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=30 September 2008; VALUE_TEXT=65.7; DOSE=At 150 mg/kg bw/day, there was a decrease in body weight gain in male animals (again from week 1, with a terminal mean bodyweight of 93% of control), but no other toxicological effects were reported.; EFFECT=oxic symptoms. Macroscopic and histological evaluation revealed discoloration of the inner organs. At 150 mg/kg bw/day, there was a decrease in body weight gain in male animals (again from week 1, with a terminal mean bodyweight of 93% of control), but no other toxicological effects were reported. Coloured urine was excreted by animals treated with 150 and 450 mg/kg, throughout the treatment period. Conclusion The dose of 50 mg/kg bw/day was tolerated without any signs of adverse effects and is regarded to be the NOAEL. Ref.: 15 Comment As the dye content of the test substance is only 65.7%, the NOAEL value is re-calculated to be 33 mg/kg/bw/day. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Test Guideline: OECD 471 (1997) Species/strain: Salmonella typhimurium TA98, TA100, TA102, TA1535 and TA1537 Replicates: triplicates in 2 individual experiments both in the presence and absence of S9-mix. Test substan; CITATION=Ref.: 15 Comment As the dye content of the test substance is only 65; CITATION_NUMBERS=[15,65]; REFERENCE=Ref.: 15 Comment As the dye content of the test substance is only 65; DETAILS_JSON={"cas_number":"26381-41-9","citation":"Ref.: 15 Comment As the dye content of the test substance is only 65","dose":"At 150 mg/kg bw/day, there was a decrease in body weight gain in male animals (again from week 1, with a terminal mean bodyweight of 93% of control), but no other toxicological effects were reported.","duration":"Chronic","effect":"oxic symptoms. Macroscopic and histological evaluation revealed discoloration of the inner organs. At 150 mg/kg bw/day, there was a decrease in body weight gain in male animals (again from week 1, with a terminal mean bodyweight of 93% of control), but no other toxicological effects were reported. Coloured urine was excreted by animals treated with 150 and 450 mg/kg, throughout the treatment period. Conclusion The dose of 50 mg/kg bw/day was tolerated without any signs of adverse effects and is regarded to be the NOAEL. Ref.: 15 Comment As the dye content of the test substance is only 65.7%, the NOAEL value is re-calculated to be 33 mg/kg/bw/day. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Test Guideline: OECD 471 (1997) Species/strain: Salmonella typhimurium TA98, TA100, TA102, TA1535 and TA1537 Replicates: triplicates in 2 individual experiments both in the presence and absence of S9-mix. Test substan","endpoint":"genotoxicity","ingredient":"Basic Brown 16","loael_value":"","noael_unit":"%","noael_value":"65.7","page":16,"route":"","species":"","study_id":"sccp_o_142_noael_002"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | genotoxicity | 65.7 | % | - | - | Chronic | genotoxicity | SOURCE_SUBDIR=sccp_o_142; REPORT_TITLE=OPINION ON Basic Brown 16 COLIPA n° C9; OPINION_NUMBER=SCCP/1165/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=30 September 2008; VALUE_TEXT=65.7; DOSE=At 150 mg/kg bw/day, there was a decrease in body weight gain in male animals (again from week 1, with a terminal mean bodyweight of 93% of control), but no other toxicological effects were reported.; EFFECT=inner organs. At 150 mg/kg bw/day, there was a decrease in body weight gain in male animals (again from week 1, with a terminal mean bodyweight of 93% of control), but no other toxicological effects were reported. Coloured urine was excreted by animals treated with 150 and 450 mg/kg, throughout the treatment period. Conclusion The dose of 50 mg/kg bw/day was tolerated without any signs of adverse effects and is regarded to be the NOAEL. Ref.: 15 Comment As the dye content of the test substance is only 65.7%, the NOAEL value is re-calculated to be 33 mg/kg/bw/day. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Test Guideline: OECD 471 (1997) Species/strain: Salmonella typhimurium TA98, TA100, TA102, TA1535 and TA1537 Replicates: triplicates in 2 individual experiments both in the presence and absence of S9-mix. Test substance: C 009 Solvent: deionised water Batch: 57861/2 Purity: 98.8 % Concentrations: Expe; CITATION=Ref.: 15 Comment As the dye content of the test substance is only 65; CITATION_NUMBERS=[15,65]; REFERENCE=Ref.: 15 Comment As the dye content of the test substance is only 65; DETAILS_JSON={"cas_number":"26381-41-9","citation":"Ref.: 15 Comment As the dye content of the test substance is only 65","dose":"At 150 mg/kg bw/day, there was a decrease in body weight gain in male animals (again from week 1, with a terminal mean bodyweight of 93% of control), but no other toxicological effects were reported.","duration":"Chronic","effect":"inner organs. At 150 mg/kg bw/day, there was a decrease in body weight gain in male animals (again from week 1, with a terminal mean bodyweight of 93% of control), but no other toxicological effects were reported. Coloured urine was excreted by animals treated with 150 and 450 mg/kg, throughout the treatment period. Conclusion The dose of 50 mg/kg bw/day was tolerated without any signs of adverse effects and is regarded to be the NOAEL. Ref.: 15 Comment As the dye content of the test substance is only 65.7%, the NOAEL value is re-calculated to be 33 mg/kg/bw/day. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Test Guideline: OECD 471 (1997) Species/strain: Salmonella typhimurium TA98, TA100, TA102, TA1535 and TA1537 Replicates: triplicates in 2 individual experiments both in the presence and absence of S9-mix. Test substance: C 009 Solvent: deionised water Batch: 57861/2 Purity: 98.8 % Concentrations: Expe","endpoint":"genotoxicity","ingredient":"Basic Brown 16","loael_value":"","noael_unit":"%","noael_value":"65.7","page":16,"route":"","species":"","study_id":"sccp_o_142_noael_003"} |
openFDA substances 4 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| openFDA substances | FDA UNII substance identifier | QEJ5GK0TG1 | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C19H21N4O.Cl","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"QEJ5GK0TG1"} |
| openFDA substances | FDA UNII substance identifier | QEJ5GK0TG1 | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C19H21N4O.Cl","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"QEJ5GK0TG1"} |
| openFDA substances | FDA UNII substance identifier | QEJ5GK0TG1 | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C19H21N4O.Cl","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"QEJ5GK0TG1"} |
| openFDA substances | FDA UNII substance identifier | QEJ5GK0TG1 | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C19H21N4O.Cl","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"QEJ5GK0TG1"} |