Abstract
4-Nitro-m-Phenylenediamine is a coal tar cosmetic used at concentrations of ≤0.1 %. In an acute oral toxicity study involving mice, the LD50 was 0.5 g/kg. 4-Nitro-m-Phenylenediamine was mutagenic in the chromosome aberrations assay and in the preincubation assay, using strains TA97, TA98, and TA 1537 of Salmonella typhimurium. The safety of use of 4-Nitro-m-Phenylenediamine in cosmetic products has not been documented and substantiated. The needed safety test data include: methods of production, ultraviolet absorption spectrum, impurities, skin absorption data, adequately performed skin irritation and sensitization studies, and dermal toxicity. It cannot be concluded that this ingredient is safe for use in cosmetic products until the cited safety data have been obtained and evaluated.
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