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1800933 
Journal Article 
Final report on the safety assessment of n-phenyl-p-phenylenediamine, n-phenyl-p-phenylenediamine hydrochloride, and n-phenyl-p-phenylenediamine sulfate 
Johnson, W 
1994 
Yes 
International Journal of Toxicology
ISSN: 1091-5818
EISSN: 1092-874X 
NIOSH/00224897 
13 
5 
374-394 
WOS:A1994PR81400006 
The safety of the hair colorants N-phenyl-p-phenylenediamine (101542) (PPD), N-phenyl-p-phenylenediamine-hydrochloride (2198596) (PPD-HCl) and N-phenyl-p-phenylenediamine-sulfate (4698297) (PPD-S) was assessed, based on a review of available data. The structure, physical and chemical properties of the aromatic amines were briefly described. The cosmetic and noncosmetic uses of the compounds were discussed. Protein binding, in-vitro binding, and hepatic metabolism of PPD and its sulfate and hydrochloride salts were considered. Toxicity data were presented for PPD and extended to PPD-HCl and PPD-S. The oral median lethal dose for rats ranged up to 1000mg/kg, and acute oral toxicity for cats showed increased methemoglobin and Heinz body formation. Rats fed more than 2,200 parts per million (ppm) PPD for 90 days showed a dose dependent weight reduction; a similar response was observed in mice fed 14,700ppm. Mice fed above 5,000ppm PPD for 91 weeks showed central nervous system damage. Dermal irritation and sensitization was not observed in guinea-pigs, and minimal effects were seen for ocular irritation (Draize irritation score 8.1 out of 110) in rabbits. While no developmental toxicity was observed in female rats orally administered PPD in one study, another demonstrated maternal and fetal toxicity as well as increases in skeletal malformations. A dosage of 2,057ppm PPD caused increases in hepatocellular neoplasms in male mice, but no evidence of carcinogenicity was observed in rats or female mice exposed to PPD orally or dermally in chronic studies. PPD was shown to be a skin irritant and a possible sensitizer from clinical data. The Cosmetic Ingredient Review Panel concluded that PPD, PPD-HCl, and PPD-S are safe for use in hair dyes at concentrations up to 1.7%. 
DCN-224557; Aromatic hydrocarbons; Amines; Comparative toxicology; In vivo studies; Skin sensitivity; Chronic toxicity; Laboratory animals; Skin exposure; Skin irritants; Cosmetics