Final Report on the Safety Assessment of 2-Chloro-p-Phenylenediamine and 2-Chloro-p-Phenylenediamine Sulfate

Abstract

2-Chloro-p-Phenylenediamine and 2-Chloro-p-Phenylenediamine Sulfate are colorants used in hair dyes at concentrations less than 1.0%. In an oral subchronic toxicity test using rats and mice, all male rats and one female rat died in the 1 % concentration of 2-Chloro-p-Phenylenediamine dose group; at 0.3%, no rats or mice died but the mean body weight gain was depressed. In the mice, one of the males and none of the females died in the 1 % dose group. In a test for ocular irritation, 2.5% 2-Chloro-p-Phenylenediamine produced, at most, only mild conjunctival inflammation. 2-Chloro-p-Phenylenediamine was not a sensitizer when assayed on abraded and intact skin. The cited chronic studies do not provide sufficient evidence to conclude that the compound was carcinogenic in either mice or rats. Epidemiological studies, both prospective and retrospective, support this conclusion. On the basis of the data presented in the report, it is concluded that 2-Chloro-p-Phenylenediamine and 2-Chloro-p-Phenylenediamine Sulfate are safe as a “coal tar” hair dye ingredient at the current concentrations of use.