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 Opinion 6 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
SCCS Opinion 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 p.13
SCCS Opinion 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 p.39
SCCS Opinion NOAEL =2 - - - 90 day reproductive toxicity Ref.: 2 Comment The study was inadequate, p.14
SCCS Opinion NOAEL =98.6 % rat oral - developmental toxicity p.33
SCCS Opinion NOAEL =50 mg/kg bw rat oral 180 days reproductive toxicity p.35
SCCS Opinion NOAEL =4 - rat dermal subchronic repeated dose toxicity p.40
Regulatory source 5 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
Regulatory source developmental toxicity 98.6 % rat oral - developmental toxicity p.33
Regulatory source developmental toxicity 50 mg/kg bw rat - - developmental toxicity p.39
Regulatory source repeated dose toxicity 4 - rat dermal subchronic repeated dose toxicity p.40
Regulatory source reproductive toxicity 2 - - - 90 day reproductive toxicity p.14
Regulatory source reproductive toxicity 50 mg/kg bw rat oral 180 days reproductive toxicity p.35