NOAEL Studies Cosmetic Ingredient

N-Phenyl-p-Phenylenediamine NOAEL Studies

INCI: N-PHENYL-P-PHENYLENEDIAMINE

CAS: 101-54-2 (free base); 2198-59-6 (HCl); 4698-29-7 (sulfate)

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

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SCCS_vision_codex 22 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
SCCS_vision_codex DERMAL_ABSORPTION =90.38 % - dermal The absorbed dose and dermal delivery of [14C]-N-Phenyl-p-phenylenediamine from the Complete Dye Base C and developer was 0.13% (0.03µg equiv./cm²) and 4.18% (0.84µg equiv./cm²) of the applied dose. Dermal absorption {"absorption_percent":"90.38%; 89.79%; 0.13%; 4.18%; 0.10%; 2.10%; 99.0%","basis":"13 Most of the applied dose was washed off at 45 minutes post dose; 90.38% and 89.79% for Complete Dye Base C and developer and the Complete Dye Base U and developer respectively. The absorbed dose and dermal delivery of [14C]-N-Phenyl-p-phenylenediamine from the Complete Dye Base C and developer was 0.13% (0.03µg equiv./cm²) and 4.18% (0.84µg equiv./cm²) of the applied dose. The absorbed dose and dermal delivery of [14C]-N- Phenyl-p-phenylenediamine from the Complete Dye Base U and developer was 0.10% (0.01µg equiv./cm²) and 2.10% (0.26µg equiv./cm²) of the applied dose. The total recovery was 99.0%. Ref.: 41","citation":"Ref.: 41","concentration_tested":"The absorbed dose and dermal delivery of [14C]-N-Phenyl-p-phenylenediamine from the Complete Dye Base C and developer was 0.13% (0.03µg equiv./cm²) and 4.18% (0.84µg equiv./cm²) of the applied dose.","page":13,"pdf":"sccp_o_089.pdf","row_type":"dermal_absorption_study"}
SCCS_vision_codex DERMAL_ABSORPTION =0.23 % - dermal Dermal absorption The absorption and dermal delivery of N-Phenyl-p-phenylenediamine from the two hair dye formulations was approximately 3 fold greater in hair dye formulation “Complete Dye Base C and developer” with 0.23% w/w of N-Phenyl-p-phenylenediamine... Dermal absorption {"absorption_percent":"0.23%; 0.14%","basis":"Dermal absorption The absorption and dermal delivery of N-Phenyl-p-phenylenediamine from the two hair dye formulations was approximately 3 fold greater in hair dye formulation “Complete Dye Base C and developer” with 0.23% w/w of N-Phenyl-p-phenylenediamine than in hair dye formulation “Complete Dye Base U and developer” with 0.14% w/w of N-Phenyl-p- phenylenediamine.","concentration_tested":"Dermal absorption The absorption and dermal delivery of N-Phenyl-p-phenylenediamine from the two hair dye formulations was approximately 3 fold greater in hair dye formulation “Complete Dye Base C and developer” with 0.23% w/w of N-Phenyl-p-phenylenediamine...","page":39,"pdf":"sccp_o_089.pdf","row_type":"dermal_absorption_study"}
SCCS_vision_codex DERMAL_ABSORPTION =90.38 % - dermal The absorbed dose and dermal delivery of [14C]-N-Phenyl-p-phenylenediamine from the Complete Dye Base C and developer was 0.13% (0.03µg equiv./cm²) and 4.18% (0.84µg equiv./cm²) of the applied dose. Dermal absorption {"absorption_percent":"90.38%; 89.79%; 0.13%; 4.18%; 0.10%; 2.10%; 99.0%","basis":"13 Most of the applied dose was washed off at 45 minutes post dose; 90.38% and 89.79% for Complete Dye Base C and developer and the Complete Dye Base U and developer respectively. The absorbed dose and dermal delivery of [14C]-N-Phenyl-p-phenylenediamine from the Complete Dye Base C and developer was 0.13% (0.03µg equiv./cm²) and 4.18% (0.84µg equiv./cm²) of the applied dose. The absorbed dose and dermal delivery of [14C]-N- Phenyl-p-phenylenediamine from the Complete Dye Base U and developer was 0.10% (0.01µg equiv./cm²) and 2.10% (0.26µg equiv./cm²) of the applied dose. The total recovery was 99.0%. Ref.: 41","citation":"Ref.: 41","concentration_tested":"The absorbed dose and dermal delivery of [14C]-N-Phenyl-p-phenylenediamine from the Complete Dye Base C and developer was 0.13% (0.03µg equiv./cm²) and 4.18% (0.84µg equiv./cm²) of the applied dose.","page":13,"pdf":"sccp_o_089.pdf","row_type":"dermal_absorption_study"}
SCCS_vision_codex DERMAL_ABSORPTION =0.23 % - dermal Dermal absorption The absorption and dermal delivery of N-Phenyl-p-phenylenediamine from the two hair dye formulations was approximately 3 fold greater in hair dye formulation “Complete Dye Base C and developer” with 0.23% w/w of N-Phenyl-p-phenylenediamine... Dermal absorption {"absorption_percent":"0.23%; 0.14%","basis":"Dermal absorption The absorption and dermal delivery of N-Phenyl-p-phenylenediamine from the two hair dye formulations was approximately 3 fold greater in hair dye formulation “Complete Dye Base C and developer” with 0.23% w/w of N-Phenyl-p-phenylenediamine than in hair dye formulation “Complete Dye Base U and developer” with 0.14% w/w of N-Phenyl-p- phenylenediamine.","concentration_tested":"Dermal absorption The absorption and dermal delivery of N-Phenyl-p-phenylenediamine from the two hair dye formulations was approximately 3 fold greater in hair dye formulation “Complete Dye Base C and developer” with 0.23% w/w of N-Phenyl-p-phenylenediamine...","page":39,"pdf":"sccp_o_089.pdf","row_type":"dermal_absorption_study"}
SCCS_vision_codex DERMAL_ABSORPTION =90.38 % - dermal The absorbed dose and dermal delivery of [14C]-N-Phenyl-p-phenylenediamine from the Complete Dye Base C and developer was 0.13% (0.03µg equiv./cm²) and 4.18% (0.84µg equiv./cm²) of the applied dose. Dermal absorption {"absorption_percent":"90.38%; 89.79%; 0.13%; 4.18%; 0.10%; 2.10%; 99.0%","basis":"13 Most of the applied dose was washed off at 45 minutes post dose; 90.38% and 89.79% for Complete Dye Base C and developer and the Complete Dye Base U and developer respectively. The absorbed dose and dermal delivery of [14C]-N-Phenyl-p-phenylenediamine from the Complete Dye Base C and developer was 0.13% (0.03µg equiv./cm²) and 4.18% (0.84µg equiv./cm²) of the applied dose. The absorbed dose and dermal delivery of [14C]-N- Phenyl-p-phenylenediamine from the Complete Dye Base U and developer was 0.10% (0.01µg equiv./cm²) and 2.10% (0.26µg equiv./cm²) of the applied dose. The total recovery was 99.0%. Ref.: 41","citation":"Ref.: 41","concentration_tested":"The absorbed dose and dermal delivery of [14C]-N-Phenyl-p-phenylenediamine from the Complete Dye Base C and developer was 0.13% (0.03µg equiv./cm²) and 4.18% (0.84µg equiv./cm²) of the applied dose.","page":13,"pdf":"sccp_o_089.pdf","row_type":"dermal_absorption_study"}
SCCS_vision_codex DERMAL_ABSORPTION =0.23 % - dermal Dermal absorption The absorption and dermal delivery of N-Phenyl-p-phenylenediamine from the two hair dye formulations was approximately 3 fold greater in hair dye formulation “Complete Dye Base C and developer” with 0.23% w/w of N-Phenyl-p-phenylenediamine... Dermal absorption {"absorption_percent":"0.23%; 0.14%","basis":"Dermal absorption The absorption and dermal delivery of N-Phenyl-p-phenylenediamine from the two hair dye formulations was approximately 3 fold greater in hair dye formulation “Complete Dye Base C and developer” with 0.23% w/w of N-Phenyl-p-phenylenediamine than in hair dye formulation “Complete Dye Base U and developer” with 0.14% w/w of N-Phenyl-p- phenylenediamine.","concentration_tested":"Dermal absorption The absorption and dermal delivery of N-Phenyl-p-phenylenediamine from the two hair dye formulations was approximately 3 fold greater in hair dye formulation “Complete Dye Base C and developer” with 0.23% w/w of N-Phenyl-p-phenylenediamine...","page":39,"pdf":"sccp_o_089.pdf","row_type":"dermal_absorption_study"}
SCCS_vision_codex NOAEL =2 - - - 90 day reproductive toxicity {"citation":"Ref.: 2 Comment The study was inadequate","effect":"suggestive of degenerative changes were seen at these doses. The testes showed impaired spermatogenesis. The lowered LDH and hyaluronidase indicated partial arrest of spermatogenesis. This was supported histopathologically. Ref.: 2 Comment The study was inadequate. This was not a study report, but a journal publication. It did not follow conventional guidelines and was not GLP. Data in this publication was only for males, though the implication was that males and females were investigated in the 90 day study. No NOAEL could be derived from this study. A new 90 day study is required with special attention to the effects on the reproduction, since fertility in the male would seem to be effected. The effects of N-Phenyl-p- phenylenediamine on females need to be addressed.","page":14,"pdf":"sccp_o_089.pdf","row_type":"noael_study","study_id":"sccp_o_089_noael_001"}
SCCS_vision_codex NOAEL =98.6 % rat oral - developmental toxicity {"citation":"Ref.: 24 Comment This is a journal publication, not a study report","dose":"There were no differences in mean foetal weights, sex ratios, external, visceral or skeletal foetal abnormalities between the control and treated groups.","effect":"no significant foetal effects seen as a result of N-Phenyl-PPD administration. There were no differences in mean foetal weights, sex ratios, external, visceral or skeletal foetal abnormalities between the control and treated groups. Conclusions N-Phenyl-p-Phenylenediamine was not teratogenic when administered to pregnant rats during the foetal period of development. Ref.: 24 Comment This is a journal publication, not a study report. It appeared to be well conducted but a complete assessment was not possible. No NOAEL could be derived from this data. Guideline: / Species: Rat, Sprague Dawley Route: oral by gavage Group sizes: 25 Substance: 4-ADPA (N-phenyl-p-phenylenediamine) Batch: 110113 Purity: 98.6% Dose: 0 and 150 mg/kg bw/day Exposure: Gestation Days (GD) 6 -15 Vehicle: corn oil Control groups: Vehicle control (corn oil), Positive control: / GLP: in compliance","page":33,"pdf":"sccp_o_089.pdf","row_type":"noael_study","study_id":"sccp_o_089_noael_002"}
SCCS_vision_codex NOAEL =50 mg/kg bw rat oral 180 days reproductive toxicity {"citation":"Ref.: 26 Comment The NOAEL for maternal and embryotoxicity was set at 50 mg/kg bw","dose":"SCCP/0991/06 OPINION ON N-PHENYL-P-PHENYLENEDIAMINE 35 administered during the foetal period of development.","effect":"SCCP/0991/06 OPINION ON N-PHENYL-P-PHENYLENEDIAMINE 35 administered during the foetal period of development. Foetotoxic effects were seen in the high dose group, mainly affecting ossification were consistent with the reduced foetal weight. Ref.: 26 Comment The NOAEL for maternal and embryotoxicity was set at 50 mg/kg bw. Fertility study Guideline: / Species: Rat, Wistar Route: intra-peritoneal for 180 days Group sizes: 30 Substance: p-ADPA (Koch-Light Labs.UK) Batch: / Purity: / Dose: 0 and 42.5 mg/kg GLP: / Food intake (pelleted diet) and body weight were recorded weekly. Testes, ventral prostate, dorso-lateral prostate, seminal vesicles & coagulating glands were recorded at the end of the experimental period. Biochemical analyses included: Testicular enzymes and biocons","page":35,"pdf":"sccp_o_089.pdf","row_type":"noael_study","study_id":"sccp_o_089_noael_003"}
SCCS_vision_codex NOAEL =4 - rat dermal subchronic repeated dose toxicity {"effect":"with rats and mice. The rat study was negative. The mice study was not adequate for evaluation. A hair dye formulation containing N-phenyl-p-phenylenediamine has also been tested together with hydrogen peroxide by topical application to mice and rats without any tumour induction. However, also in cases where known carcinogens were present in the hair dye formulation, no tumours were induced. Thus, no conclusions with regards to carcinogenicity can be drawn from the skin painting studies. 4. CONCLUSION A proper NO(A)EL for subchronic toxicity cannot be set due to the shortcomings of the experimental data provided. Data is required to meet modern guidelines with special attention to the effects on fertility together with reproductive parameters. The current lack of data on the effects of N-Phenyl- p-phenylenediamine on females needs to be addressed since maternotoxicity was seen in the developmental studies. In addition, liver effects were noted in males. In the male, fertility seems to be compromised with signs of testicular to","page":40,"pdf":"sccp_o_089.pdf","row_type":"noael_study","study_id":"sccp_o_089_noael_005"}
SCCS_vision_codex NOAEL =2 - - - 90 day reproductive toxicity {"citation":"Ref.: 2 Comment The study was inadequate","effect":"suggestive of degenerative changes were seen at these doses. The testes showed impaired spermatogenesis. The lowered LDH and hyaluronidase indicated partial arrest of spermatogenesis. This was supported histopathologically. Ref.: 2 Comment The study was inadequate. This was not a study report, but a journal publication. It did not follow conventional guidelines and was not GLP. Data in this publication was only for males, though the implication was that males and females were investigated in the 90 day study. No NOAEL could be derived from this study. A new 90 day study is required with special attention to the effects on the reproduction, since fertility in the male would seem to be effected. The effects of N-Phenyl-p- phenylenediamine on females need to be addressed.","page":14,"pdf":"sccp_o_089.pdf","row_type":"noael_study","study_id":"sccp_o_089_noael_001"}
SCCS_vision_codex NOAEL =98.6 % rat oral - developmental toxicity {"citation":"Ref.: 24 Comment This is a journal publication, not a study report","dose":"There were no differences in mean foetal weights, sex ratios, external, visceral or skeletal foetal abnormalities between the control and treated groups.","effect":"no significant foetal effects seen as a result of N-Phenyl-PPD administration. There were no differences in mean foetal weights, sex ratios, external, visceral or skeletal foetal abnormalities between the control and treated groups. Conclusions N-Phenyl-p-Phenylenediamine was not teratogenic when administered to pregnant rats during the foetal period of development. Ref.: 24 Comment This is a journal publication, not a study report. It appeared to be well conducted but a complete assessment was not possible. No NOAEL could be derived from this data. Guideline: / Species: Rat, Sprague Dawley Route: oral by gavage Group sizes: 25 Substance: 4-ADPA (N-phenyl-p-phenylenediamine) Batch: 110113 Purity: 98.6% Dose: 0 and 150 mg/kg bw/day Exposure: Gestation Days (GD) 6 -15 Vehicle: corn oil Control groups: Vehicle control (corn oil), Positive control: / GLP: in compliance","page":33,"pdf":"sccp_o_089.pdf","row_type":"noael_study","study_id":"sccp_o_089_noael_002"}
SCCS_vision_codex NOAEL =50 mg/kg bw rat oral 180 days reproductive toxicity {"citation":"Ref.: 26 Comment The NOAEL for maternal and embryotoxicity was set at 50 mg/kg bw","dose":"SCCP/0991/06 OPINION ON N-PHENYL-P-PHENYLENEDIAMINE 35 administered during the foetal period of development.","effect":"SCCP/0991/06 OPINION ON N-PHENYL-P-PHENYLENEDIAMINE 35 administered during the foetal period of development. Foetotoxic effects were seen in the high dose group, mainly affecting ossification were consistent with the reduced foetal weight. Ref.: 26 Comment The NOAEL for maternal and embryotoxicity was set at 50 mg/kg bw. Fertility study Guideline: / Species: Rat, Wistar Route: intra-peritoneal for 180 days Group sizes: 30 Substance: p-ADPA (Koch-Light Labs.UK) Batch: / Purity: / Dose: 0 and 42.5 mg/kg GLP: / Food intake (pelleted diet) and body weight were recorded weekly. Testes, ventral prostate, dorso-lateral prostate, seminal vesicles & coagulating glands were recorded at the end of the experimental period. Biochemical analyses included: Testicular enzymes and biocons","page":35,"pdf":"sccp_o_089.pdf","row_type":"noael_study","study_id":"sccp_o_089_noael_003"}
SCCS_vision_codex NOAEL =4 - rat dermal subchronic repeated dose toxicity {"effect":"with rats and mice. The rat study was negative. The mice study was not adequate for evaluation. A hair dye formulation containing N-phenyl-p-phenylenediamine has also been tested together with hydrogen peroxide by topical application to mice and rats without any tumour induction. However, also in cases where known carcinogens were present in the hair dye formulation, no tumours were induced. Thus, no conclusions with regards to carcinogenicity can be drawn from the skin painting studies. 4. CONCLUSION A proper NO(A)EL for subchronic toxicity cannot be set due to the shortcomings of the experimental data provided. Data is required to meet modern guidelines with special attention to the effects on fertility together with reproductive parameters. The current lack of data on the effects of N-Phenyl- p-phenylenediamine on females needs to be addressed since maternotoxicity was seen in the developmental studies. In addition, liver effects were noted in males. In the male, fertility seems to be compromised with signs of testicular to","page":40,"pdf":"sccp_o_089.pdf","row_type":"noael_study","study_id":"sccp_o_089_noael_005"}
SCCS_vision_codex NOAEL =2 - - - 90 day reproductive toxicity {"citation":"Ref.: 2 Comment The study was inadequate","effect":"suggestive of degenerative changes were seen at these doses. The testes showed impaired spermatogenesis. The lowered LDH and hyaluronidase indicated partial arrest of spermatogenesis. This was supported histopathologically. Ref.: 2 Comment The study was inadequate. This was not a study report, but a journal publication. It did not follow conventional guidelines and was not GLP. Data in this publication was only for males, though the implication was that males and females were investigated in the 90 day study. No NOAEL could be derived from this study. A new 90 day study is required with special attention to the effects on the reproduction, since fertility in the male would seem to be effected. The effects of N-Phenyl-p- phenylenediamine on females need to be addressed.","page":14,"pdf":"sccp_o_089.pdf","row_type":"noael_study","study_id":"sccp_o_089_noael_001"}
SCCS_vision_codex NOAEL =98.6 % rat oral - developmental toxicity {"citation":"Ref.: 24 Comment This is a journal publication, not a study report","dose":"There were no differences in mean foetal weights, sex ratios, external, visceral or skeletal foetal abnormalities between the control and treated groups.","effect":"no significant foetal effects seen as a result of N-Phenyl-PPD administration. There were no differences in mean foetal weights, sex ratios, external, visceral or skeletal foetal abnormalities between the control and treated groups. Conclusions N-Phenyl-p-Phenylenediamine was not teratogenic when administered to pregnant rats during the foetal period of development. Ref.: 24 Comment This is a journal publication, not a study report. It appeared to be well conducted but a complete assessment was not possible. No NOAEL could be derived from this data. Guideline: / Species: Rat, Sprague Dawley Route: oral by gavage Group sizes: 25 Substance: 4-ADPA (N-phenyl-p-phenylenediamine) Batch: 110113 Purity: 98.6% Dose: 0 and 150 mg/kg bw/day Exposure: Gestation Days (GD) 6 -15 Vehicle: corn oil Control groups: Vehicle control (corn oil), Positive control: / GLP: in compliance","page":33,"pdf":"sccp_o_089.pdf","row_type":"noael_study","study_id":"sccp_o_089_noael_002"}
SCCS_vision_codex NOAEL =50 mg/kg bw rat oral 180 days reproductive toxicity {"citation":"Ref.: 26 Comment The NOAEL for maternal and embryotoxicity was set at 50 mg/kg bw","dose":"SCCP/0991/06 OPINION ON N-PHENYL-P-PHENYLENEDIAMINE 35 administered during the foetal period of development.","effect":"SCCP/0991/06 OPINION ON N-PHENYL-P-PHENYLENEDIAMINE 35 administered during the foetal period of development. Foetotoxic effects were seen in the high dose group, mainly affecting ossification were consistent with the reduced foetal weight. Ref.: 26 Comment The NOAEL for maternal and embryotoxicity was set at 50 mg/kg bw. Fertility study Guideline: / Species: Rat, Wistar Route: intra-peritoneal for 180 days Group sizes: 30 Substance: p-ADPA (Koch-Light Labs.UK) Batch: / Purity: / Dose: 0 and 42.5 mg/kg GLP: / Food intake (pelleted diet) and body weight were recorded weekly. Testes, ventral prostate, dorso-lateral prostate, seminal vesicles & coagulating glands were recorded at the end of the experimental period. Biochemical analyses included: Testicular enzymes and biocons","page":35,"pdf":"sccp_o_089.pdf","row_type":"noael_study","study_id":"sccp_o_089_noael_003"}
SCCS_vision_codex NOAEL =4 - rat dermal subchronic repeated dose toxicity {"effect":"with rats and mice. The rat study was negative. The mice study was not adequate for evaluation. A hair dye formulation containing N-phenyl-p-phenylenediamine has also been tested together with hydrogen peroxide by topical application to mice and rats without any tumour induction. However, also in cases where known carcinogens were present in the hair dye formulation, no tumours were induced. Thus, no conclusions with regards to carcinogenicity can be drawn from the skin painting studies. 4. CONCLUSION A proper NO(A)EL for subchronic toxicity cannot be set due to the shortcomings of the experimental data provided. Data is required to meet modern guidelines with special attention to the effects on fertility together with reproductive parameters. The current lack of data on the effects of N-Phenyl- p-phenylenediamine on females needs to be addressed since maternotoxicity was seen in the developmental studies. In addition, liver effects were noted in males. In the male, fertility seems to be compromised with signs of testicular to","page":40,"pdf":"sccp_o_089.pdf","row_type":"noael_study","study_id":"sccp_o_089_noael_005"}
SCCS_vision_codex NOAEL =2 - - - 90 day reproductive toxicity {"citation":"Ref.: 2 Comment The study was inadequate","effect":"suggestive of degenerative changes were seen at these doses. The testes showed impaired spermatogenesis. The lowered LDH and hyaluronidase indicated partial arrest of spermatogenesis. This was supported histopathologically. Ref.: 2 Comment The study was inadequate. This was not a study report, but a journal publication. It did not follow conventional guidelines and was not GLP. Data in this publication was only for males, though the implication was that males and females were investigated in the 90 day study. No NOAEL could be derived from this study. A new 90 day study is required with special attention to the effects on the reproduction, since fertility in the male would seem to be effected. The effects of N-Phenyl-p- phenylenediamine on females need to be addressed.","page":14,"pdf":"sccp_o_089.pdf","row_type":"noael_study","study_id":"sccp_o_089_noael_001"}
SCCS_vision_codex NOAEL =98.6 % rat oral - developmental toxicity {"citation":"Ref.: 24 Comment This is a journal publication, not a study report","dose":"There were no differences in mean foetal weights, sex ratios, external, visceral or skeletal foetal abnormalities between the control and treated groups.","effect":"no significant foetal effects seen as a result of N-Phenyl-PPD administration. There were no differences in mean foetal weights, sex ratios, external, visceral or skeletal foetal abnormalities between the control and treated groups. Conclusions N-Phenyl-p-Phenylenediamine was not teratogenic when administered to pregnant rats during the foetal period of development. Ref.: 24 Comment This is a journal publication, not a study report. It appeared to be well conducted but a complete assessment was not possible. No NOAEL could be derived from this data. Guideline: / Species: Rat, Sprague Dawley Route: oral by gavage Group sizes: 25 Substance: 4-ADPA (N-phenyl-p-phenylenediamine) Batch: 110113 Purity: 98.6% Dose: 0 and 150 mg/kg bw/day Exposure: Gestation Days (GD) 6 -15 Vehicle: corn oil Control groups: Vehicle control (corn oil), Positive control: / GLP: in compliance","page":33,"pdf":"sccp_o_089.pdf","row_type":"noael_study","study_id":"sccp_o_089_noael_002"}
SCCS_vision_codex NOAEL =50 mg/kg bw rat oral 180 days reproductive toxicity {"citation":"Ref.: 26 Comment The NOAEL for maternal and embryotoxicity was set at 50 mg/kg bw","dose":"SCCP/0991/06 OPINION ON N-PHENYL-P-PHENYLENEDIAMINE 35 administered during the foetal period of development.","effect":"SCCP/0991/06 OPINION ON N-PHENYL-P-PHENYLENEDIAMINE 35 administered during the foetal period of development. Foetotoxic effects were seen in the high dose group, mainly affecting ossification were consistent with the reduced foetal weight. Ref.: 26 Comment The NOAEL for maternal and embryotoxicity was set at 50 mg/kg bw. Fertility study Guideline: / Species: Rat, Wistar Route: intra-peritoneal for 180 days Group sizes: 30 Substance: p-ADPA (Koch-Light Labs.UK) Batch: / Purity: / Dose: 0 and 42.5 mg/kg GLP: / Food intake (pelleted diet) and body weight were recorded weekly. Testes, ventral prostate, dorso-lateral prostate, seminal vesicles & coagulating glands were recorded at the end of the experimental period. Biochemical analyses included: Testicular enzymes and biocons","page":35,"pdf":"sccp_o_089.pdf","row_type":"noael_study","study_id":"sccp_o_089_noael_003"}
SCCS_vision_codex NOAEL =4 - rat dermal subchronic repeated dose toxicity {"effect":"with rats and mice. The rat study was negative. The mice study was not adequate for evaluation. A hair dye formulation containing N-phenyl-p-phenylenediamine has also been tested together with hydrogen peroxide by topical application to mice and rats without any tumour induction. However, also in cases where known carcinogens were present in the hair dye formulation, no tumours were induced. Thus, no conclusions with regards to carcinogenicity can be drawn from the skin painting studies. 4. CONCLUSION A proper NO(A)EL for subchronic toxicity cannot be set due to the shortcomings of the experimental data provided. Data is required to meet modern guidelines with special attention to the effects on fertility together with reproductive parameters. The current lack of data on the effects of N-Phenyl- p-phenylenediamine on females needs to be addressed since maternotoxicity was seen in the developmental studies. In addition, liver effects were noted in males. In the male, fertility seems to be compromised with signs of testicular to","page":40,"pdf":"sccp_o_089.pdf","row_type":"noael_study","study_id":"sccp_o_089_noael_005"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies 5 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 98.6 % rat oral - developmental toxicity SOURCE_SUBDIR=sccp_o_089; REPORT_TITLE=OPINION ON N-PHENYL-P-PHENYLENEDIAMINE COLIPA N° A9; OPINION_NUMBER=SCCP/0991/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=19 December 2006; VALUE_TEXT=98.6; DOSE=There were no differences in mean foetal weights, sex ratios, external, visceral or skeletal foetal abnormalities between the control and treated groups.; EFFECT=no significant foetal effects seen as a result of N-Phenyl-PPD administration. There were no differences in mean foetal weights, sex ratios, external, visceral or skeletal foetal abnormalities between the control and treated groups. Conclusions N-Phenyl-p-Phenylenediamine was not teratogenic when administered to pregnant rats during the foetal period of development. Ref.: 24 Comment This is a journal publication, not a study report. It appeared to be well conducted but a complete assessment was not possible. No NOAEL could be derived from this data. Guideline: / Species: Rat, Sprague Dawley Route: oral by gavage Group sizes: 25 Substance: 4-ADPA (N-phenyl-p-phenylenediamine) Batch: 110113 Purity: 98.6% Dose: 0 and 150 mg/kg bw/day Exposure: Gestation Days (GD) 6 -15 Vehicle: corn oil Control groups: Vehicle control (corn oil), Positive control: / GLP: in compliance; CITATION=Ref.: 24 Comment This is a journal publication, not a study report; CITATION_NUMBERS=[24]; REFERENCE=Ref.: 24 Comment This is a journal publication, not a study report; DETAILS_JSON={"cas_number":"101-54-2","citation":"Ref.: 24 Comment This is a journal publication, not a study report","dose":"There were no differences in mean foetal weights, sex ratios, external, visceral or skeletal foetal abnormalities between the control and treated groups.","duration":"","effect":"no significant foetal effects seen as a result of N-Phenyl-PPD administration. There were no differences in mean foetal weights, sex ratios, external, visceral or skeletal foetal abnormalities between the control and treated groups. Conclusions N-Phenyl-p-Phenylenediamine was not teratogenic when administered to pregnant rats during the foetal period of development. Ref.: 24 Comment This is a journal publication, not a study report. It appeared to be well conducted but a complete assessment was not possible. No NOAEL could be derived from this data. Guideline: / Species: Rat, Sprague Dawley Route: oral by gavage Group sizes: 25 Substance: 4-ADPA (N-phenyl-p-phenylenediamine) Batch: 110113 Purity: 98.6% Dose: 0 and 150 mg/kg bw/day Exposure: Gestation Days (GD) 6 -15 Vehicle: corn oil Control groups: Vehicle control (corn oil), Positive control: / GLP: in compliance","endpoint":"developmental toxicity","ingredient":"N-Phenyl-p-Phenylenediamine","loael_value":"","noael_unit":"%","noael_value":"98.6","page":33,"route":"oral","species":"rat","study_id":"sccp_o_089_noael_002"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 50 mg/kg bw rat - - developmental toxicity SOURCE_SUBDIR=sccp_o_089; REPORT_TITLE=OPINION ON N-PHENYL-P-PHENYLENEDIAMINE COLIPA N° A9; OPINION_NUMBER=SCCP/0991/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=19 December 2006; VALUE_TEXT=50; DOSE=N-Phenyl-p-phenylenediamine, at doses lower than those associated with maternal toxicity, was not embryotoxic, foetotoxic or teratogenic in the Sprague Dawley rat when administered during the foetal period of development.; EFFECT=ly reduced enzyme levels implying reduced energy availability during spermatogenesis (publication in journal). In male rats, effects were also noted in the liver. N-Phenyl-p-phenylenediamine, at doses lower than those associated with maternal toxicity, was not embryotoxic, foetotoxic or teratogenic in the Sprague Dawley rat when administered during the foetal period of development. Foetotoxic effects were seen in the high dose group, mainly affecting ossification were consistent with the reduced foetal weight. The NOAEL for maternal and embryotoxicity was set at 50 mg/kg bw. Irritation, sensitisation The study concerning the skin irritation is not respecting the actual guidelines and is considered inadequate. Nevertheless the results can be accepted and N-Phenyl-p- phenylenediamine is classified as a non irritant substance. Numerous publications demonstrate that N-Phenyl-p-phenylenediamine is a strong sensitizer in humans. The LLNA studies conducted according to the OECD guideline show that N-Phenyl-p-phenylenediamine is an ext; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-54-2","citation":"","dose":"N-Phenyl-p-phenylenediamine, at doses lower than those associated with maternal toxicity, was not embryotoxic, foetotoxic or teratogenic in the Sprague Dawley rat when administered during the foetal period of development.","duration":"","effect":"ly reduced enzyme levels implying reduced energy availability during spermatogenesis (publication in journal). In male rats, effects were also noted in the liver. N-Phenyl-p-phenylenediamine, at doses lower than those associated with maternal toxicity, was not embryotoxic, foetotoxic or teratogenic in the Sprague Dawley rat when administered during the foetal period of development. Foetotoxic effects were seen in the high dose group, mainly affecting ossification were consistent with the reduced foetal weight. The NOAEL for maternal and embryotoxicity was set at 50 mg/kg bw. Irritation, sensitisation The study concerning the skin irritation is not respecting the actual guidelines and is considered inadequate. Nevertheless the results can be accepted and N-Phenyl-p- phenylenediamine is classified as a non irritant substance. Numerous publications demonstrate that N-Phenyl-p-phenylenediamine is a strong sensitizer in humans. The LLNA studies conducted according to the OECD guideline show that N-Phenyl-p-phenylenediamine is an ext","endpoint":"developmental toxicity","ingredient":"N-Phenyl-p-Phenylenediamine","loael_value":"","noael_unit":"mg/kg bw","noael_value":"50","page":39,"route":"","species":"rat","study_id":"sccp_o_089_noael_004"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 4 - rat dermal subchronic repeated dose toxicity SOURCE_SUBDIR=sccp_o_089; REPORT_TITLE=OPINION ON N-PHENYL-P-PHENYLENEDIAMINE COLIPA N° A9; OPINION_NUMBER=SCCP/0991/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=19 December 2006; VALUE_TEXT=unclear:with rats and mice. The rat study was negative. The mice study was not adequate for evaluation. A hair dye formulation containing N-phenyl-p-phenylenediamine has also been tested together with hydrogen peroxide by topical application to mice and rats without any tumour induction. However, also in cases where known carcinogens were present in the hair dye formulation, no tumours were induced. Thus, no conclusions with regards to carcinogenicity can be drawn from the skin painting studies. 4. CONCLUSION A proper NO(A)EL for subchronic toxicity cannot be set due to the shortcomings of the experimental data provided. Data is required to meet modern guidelines with special attention to the effects on fertility together with reproductive parameters. The current lack of data on the effects of N-Phenyl- p-phenylenediamine on females needs to be addressed since maternotoxicity was seen in the developmental studies. In addition, liver effects were noted in males. In the male, fertility seems to be compromised with signs of testicular to; EFFECT=with rats and mice. The rat study was negative. The mice study was not adequate for evaluation. A hair dye formulation containing N-phenyl-p-phenylenediamine has also been tested together with hydrogen peroxide by topical application to mice and rats without any tumour induction. However, also in cases where known carcinogens were present in the hair dye formulation, no tumours were induced. Thus, no conclusions with regards to carcinogenicity can be drawn from the skin painting studies. 4. CONCLUSION A proper NO(A)EL for subchronic toxicity cannot be set due to the shortcomings of the experimental data provided. Data is required to meet modern guidelines with special attention to the effects on fertility together with reproductive parameters. The current lack of data on the effects of N-Phenyl- p-phenylenediamine on females needs to be addressed since maternotoxicity was seen in the developmental studies. In addition, liver effects were noted in males. In the male, fertility seems to be compromised with signs of testicular to; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-54-2","citation":"","dose":"","duration":"subchronic","effect":"with rats and mice. The rat study was negative. The mice study was not adequate for evaluation. A hair dye formulation containing N-phenyl-p-phenylenediamine has also been tested together with hydrogen peroxide by topical application to mice and rats without any tumour induction. However, also in cases where known carcinogens were present in the hair dye formulation, no tumours were induced. Thus, no conclusions with regards to carcinogenicity can be drawn from the skin painting studies. 4. CONCLUSION A proper NO(A)EL for subchronic toxicity cannot be set due to the shortcomings of the experimental data provided. Data is required to meet modern guidelines with special attention to the effects on fertility together with reproductive parameters. The current lack of data on the effects of N-Phenyl- p-phenylenediamine on females needs to be addressed since maternotoxicity was seen in the developmental studies. In addition, liver effects were noted in males. In the male, fertility seems to be compromised with signs of testicular to","endpoint":"repeated dose toxicity","ingredient":"N-Phenyl-p-Phenylenediamine","loael_value":"","noael_unit":"","noael_value":"unclear:with rats and mice. The rat study was negative. The mice study was not adequate for evaluation. A hair dye formulation containing N-phenyl-p-phenylenediamine has also been tested together with hydrogen peroxide by topical application to mice and rats without any tumour induction. However, also in cases where known carcinogens were present in the hair dye formulation, no tumours were induced. Thus, no conclusions with regards to carcinogenicity can be drawn from the skin painting studies. 4. CONCLUSION A proper NO(A)EL for subchronic toxicity cannot be set due to the shortcomings of the experimental data provided. Data is required to meet modern guidelines with special attention to the effects on fertility together with reproductive parameters. The current lack of data on the effects of N-Phenyl- p-phenylenediamine on females needs to be addressed since maternotoxicity was seen in the developmental studies. In addition, liver effects were noted in males. In the male, fertility seems to be compromised with signs of testicular to","page":40,"route":"dermal","species":"rat","study_id":"sccp_o_089_noael_005"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies reproductive toxicity 2 - - - 90 day reproductive toxicity SOURCE_SUBDIR=sccp_o_089; REPORT_TITLE=OPINION ON N-PHENYL-P-PHENYLENEDIAMINE COLIPA N° A9; OPINION_NUMBER=SCCP/0991/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=19 December 2006; VALUE_TEXT=unclear:suggestive of degenerative changes were seen at these doses. The testes showed impaired spermatogenesis. The lowered LDH and hyaluronidase indicated partial arrest of spermatogenesis. This was supported histopathologically. Ref.: 2 Comment The study was inadequate. This was not a study report, but a journal publication. It did not follow conventional guidelines and was not GLP. Data in this publication was only for males, though the implication was that males and females were investigated in the 90 day study. No NOAEL could be derived from this study. A new 90 day study is required with special attention to the effects on the reproduction, since fertility in the male would seem to be effected. The effects of N-Phenyl-p- phenylenediamine on females need to be addressed.; EFFECT=suggestive of degenerative changes were seen at these doses. The testes showed impaired spermatogenesis. The lowered LDH and hyaluronidase indicated partial arrest of spermatogenesis. This was supported histopathologically. Ref.: 2 Comment The study was inadequate. This was not a study report, but a journal publication. It did not follow conventional guidelines and was not GLP. Data in this publication was only for males, though the implication was that males and females were investigated in the 90 day study. No NOAEL could be derived from this study. A new 90 day study is required with special attention to the effects on the reproduction, since fertility in the male would seem to be effected. The effects of N-Phenyl-p- phenylenediamine on females need to be addressed.; CITATION=Ref.: 2 Comment The study was inadequate; CITATION_NUMBERS=[2]; REFERENCE=Ref.: 2 Comment The study was inadequate; DETAILS_JSON={"cas_number":"101-54-2","citation":"Ref.: 2 Comment The study was inadequate","dose":"","duration":"90 day","effect":"suggestive of degenerative changes were seen at these doses. The testes showed impaired spermatogenesis. The lowered LDH and hyaluronidase indicated partial arrest of spermatogenesis. This was supported histopathologically. Ref.: 2 Comment The study was inadequate. This was not a study report, but a journal publication. It did not follow conventional guidelines and was not GLP. Data in this publication was only for males, though the implication was that males and females were investigated in the 90 day study. No NOAEL could be derived from this study. A new 90 day study is required with special attention to the effects on the reproduction, since fertility in the male would seem to be effected. The effects of N-Phenyl-p- phenylenediamine on females need to be addressed.","endpoint":"reproductive toxicity","ingredient":"N-Phenyl-p-Phenylenediamine","loael_value":"","noael_unit":"","noael_value":"unclear:suggestive of degenerative changes were seen at these doses. The testes showed impaired spermatogenesis. The lowered LDH and hyaluronidase indicated partial arrest of spermatogenesis. This was supported histopathologically. Ref.: 2 Comment The study was inadequate. This was not a study report, but a journal publication. It did not follow conventional guidelines and was not GLP. Data in this publication was only for males, though the implication was that males and females were investigated in the 90 day study. No NOAEL could be derived from this study. A new 90 day study is required with special attention to the effects on the reproduction, since fertility in the male would seem to be effected. The effects of N-Phenyl-p- phenylenediamine on females need to be addressed.","page":14,"route":"","species":"","study_id":"sccp_o_089_noael_001"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies reproductive toxicity 50 mg/kg bw rat oral 180 days reproductive toxicity SOURCE_SUBDIR=sccp_o_089; REPORT_TITLE=OPINION ON N-PHENYL-P-PHENYLENEDIAMINE COLIPA N° A9; OPINION_NUMBER=SCCP/0991/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=19 December 2006; VALUE_TEXT=50; DOSE=SCCP/0991/06 OPINION ON N-PHENYL-P-PHENYLENEDIAMINE 35 administered during the foetal period of development.; EFFECT=SCCP/0991/06 OPINION ON N-PHENYL-P-PHENYLENEDIAMINE 35 administered during the foetal period of development. Foetotoxic effects were seen in the high dose group, mainly affecting ossification were consistent with the reduced foetal weight. Ref.: 26 Comment The NOAEL for maternal and embryotoxicity was set at 50 mg/kg bw. Fertility study Guideline: / Species: Rat, Wistar Route: intra-peritoneal for 180 days Group sizes: 30 Substance: p-ADPA (Koch-Light Labs.UK) Batch: / Purity: / Dose: 0 and 42.5 mg/kg GLP: / Food intake (pelleted diet) and body weight were recorded weekly. Testes, ventral prostate, dorso-lateral prostate, seminal vesicles & coagulating glands were recorded at the end of the experimental period. Biochemical analyses included: Testicular enzymes and biocons; CITATION=Ref.: 26 Comment The NOAEL for maternal and embryotoxicity was set at 50 mg/kg bw; CITATION_NUMBERS=[26,50]; REFERENCE=Ref.: 26 Comment The NOAEL for maternal and embryotoxicity was set at 50 mg/kg bw; DETAILS_JSON={"cas_number":"101-54-2","citation":"Ref.: 26 Comment The NOAEL for maternal and embryotoxicity was set at 50 mg/kg bw","dose":"SCCP/0991/06 OPINION ON N-PHENYL-P-PHENYLENEDIAMINE 35 administered during the foetal period of development.","duration":"180 days","effect":"SCCP/0991/06 OPINION ON N-PHENYL-P-PHENYLENEDIAMINE 35 administered during the foetal period of development. Foetotoxic effects were seen in the high dose group, mainly affecting ossification were consistent with the reduced foetal weight. Ref.: 26 Comment The NOAEL for maternal and embryotoxicity was set at 50 mg/kg bw. Fertility study Guideline: / Species: Rat, Wistar Route: intra-peritoneal for 180 days Group sizes: 30 Substance: p-ADPA (Koch-Light Labs.UK) Batch: / Purity: / Dose: 0 and 42.5 mg/kg GLP: / Food intake (pelleted diet) and body weight were recorded weekly. Testes, ventral prostate, dorso-lateral prostate, seminal vesicles & coagulating glands were recorded at the end of the experimental period. Biochemical analyses included: Testicular enzymes and biocons","endpoint":"reproductive toxicity","ingredient":"N-Phenyl-p-Phenylenediamine","loael_value":"","noael_unit":"mg/kg bw","noael_value":"50","page":35,"route":"oral","species":"rat","study_id":"sccp_o_089_noael_003"}