Final Report on the Safety Assessment of p-Methylaminophenol Sulfate

Abstract

p-Methylaminophenol Sulfate is a substituted phenol used as a dye and a photographic developer. In skin absorption studies of radioactive p-aminophenol, as much as 11% of the radioactivity was found in the excreta, viscera, and skin of rats. In subchronic and chronic dermal toxicity studies of hair dyes containing p-Methylaminophenol Sulfate, among other active ingredients, no toxicologically significant differences were observed between the test and control animals. In an ocular irritation study, this ingredient was considered practically nonirritating to the rabbit eye and only slightly irritating to the skin and was not a sensitizer. No significant embryotoxic or teratogenic effects were found when hair dyes containing p-Methylaminophenol Sulfate were administered to rats. p-Methylaminophenol was not mutagenic in the Ames assay nor in the mouse micronucleus assay and in the Chinese hamster ovary chromosome aberration test. No statistically significant incidences of neoplasms, dermal and other, were found in mice after 21 and 23 months of weekly dermal exposure to hair dyes containing p-Methylaminophenol Sulfate. When p-Methylaminophenol Sulfate was tested in 200 eczema patients without known previous contact with the chemical, 1 patient had a positive reaction. On the basis of the available data presented in this report, it is concluded that p-Methylaminophenol Sulfate is safe as a cosmetic ingredient in the present practices of use and concentration.