Expert Panel for Cosmetic Ingredient Safety:
The safety of 3-methylamino-4-nitrophenoxyethanol has been assessed by the Expert Panel for Cosmetic Ingredient Safety. The Expert Panel evaluated the scientific data and concluded that 3-methylamino-4-nitrophenoxyethanol was safe as a hair dye ingredient.
When applied to human skin, 0.42% of the applied 3-methylamino-4-nitrophenoxyethanol was recovered in the receptor fluid. The NOAEL (No Observed Adverse Effect Level) for 3-methylamino-4-nitrophenoxyethanol was 100 mg/kg/day in subchronic toxicity tests using 25, 100, or 400 mg/kg/day for up to 93 days. Two percent 3-methylamino-4-nitrophenoxyethanol was a slight ocular irritant but not a dermal irritant and it was not a sensitizer using the Local Lymph Node Assay. There were no embryotoxic or developmental effects observed at doses up to 750 mg/kg/day; the NOAEL was defined as 100 mg/kg. 3-methylamino-4-nitrophenoxyethanol was not genotoxic in in vitro assays including multiple strains of Salmonella typhimurium and Escherichia coli, Chinese Hamster Ovary cells, and human lymphocyte cultures. No carcinogenicity studies were available, nor were any clinical tests reported.
Many hair dye epidemiology studies are available that evaluate the possible link between hair dye use and cancer and other diseases, but these studies do not support a causal relationship between hair dye use and cancer or other diseases. The Expert Panel considered the low percutaneous absorption, and the NOAEL values for developmental toxicity data and sub chronic toxicity were sufficiently high to alleviate concern about the absence of chronic exposure data. In addition, several studies demonstrated that 3-methylamino-4-nitrophenoxyethanol was not genotoxic.
More information about the safety of hair dyes.
3-Methylamino-4-nitrophenoxyethanol is listed in the Cosmetics Directive of the European Union and may be used as a non-oxidizing coloring agent for hair dyeing at a maximum concentration of 0.15% in the finished product (see Annex III).