6 Final Report on the Safety Assessment of p-Phenylenediamine

Abstract

p-Phenylenediamine is a cosmetic hair dye intermediate used in permanent hair coloring products at concentrations of up to 5 percent (diluted 1:1 with an oxidizing agent prior to application). The extensive animal toxicity test data on p-Phenylenediamine and permanent cosmetic hair dyes containing this compound show that the degree of toxicity varies with concentration, test system and animal species. Animal data support a conclusion that this compound is neither a teratogen nor a carcinogen. Epidemiological data also support that hair dyes containing this ingredient are not carcinogenic. p-Phenylenediamine is a sensitizer and some persons may be sensitized under intended conditions of use. For those persons not sensitized, it is concluded that p-Phenylenediamine is safe as a hair dye ingredient at the current concentrations of use.