Final Report On the Safety Assessment of m-Phenylenediamine and m-Phenylenediamine Sulfate1

Abstract

The ingredients m-Phenylenediamine and m-Phenylenediamine Sulfate are aromatic amines that function as hair colorants in cosmetic products. Both are currently used in hair dye products at concentrations of up to 3%. Percutaneous absorption of m-Phenylenediamine has been demonstrated in animals. Three metabolites excreted in urine have been identified. The oral LD50 of m-Phenylenediamine in rats is between 360 and 650 mg/kg. Subchronic studies in rats (oral) indicated some lesions in the liver but no kidney injury, while one study in rabbits (dermal) indicated some liver and kidney toxicity. Another dermal study in rabbits failed to show any liver or kidney toxicity. Skin irritation and sensitization were found in guinea pigs exposed to m-Phenylenediamine. Clinical data indicated some evidence of sensitization. A short-term study in rats (oral) reported an absence of any neurotoxicity. One study in female rats identified fetotoxicity but no evidence of terata. Other studies reported neither birth defects nor fetal deaths. Both positive and negative results were found in various mutagenesis assay systems. In studies with mice and rats, neither m-Phenylenediamine (both oral and dermal exposure) nor hair dye formulations (dermal exposure only) containing m-Phenylenediamine were carcinogenic. Based on the concentrations of m-Phenylenediamine shown to produce sensitization in animal studies, it was concluded that these ingredients can be used safely in hair dyes at concentrations of up to 10%.