Toxicity and human health risk of hair dyes.

Hair dyes and their ingredients have moderate to low acute toxicity. Human poisoning accidents are rare and have only been reported following oral ingestion. Contact sensitisation to hair dyes has been a safety issue, mainly as a consequence of unprotected professional exposure. Although the use of hair dyes has dramatically increased in industrialised countries during the last decades, the prevalence of sensitisation to hair dyes in the general and professional populations has stabilised or declined. In vitro genotoxicity tests on hair dye ingredients frequently had positive results, although their correlation with in vivo carcinogenicity for the chemical class of oxidative hair dye ingredients (aromatic amines) is uncertain. Positive in vivo genotoxicity results on hair dyes are rare. Studies in man found no evidence of genotoxic effects of hair dyes or their ingredients. On the basis of mechanistic studies, some in vivo positive hair dye ingredients (p-aminophenol, Lawsone) have been shown to pose no or negligible risk to human health. Although a recent case-control epidemiology study suggested an association of hair dye use and bladder cancer, a number of other studies, including prospective investigations on large populations, found no or negative correlations for bladder or other cancers. Although in vivo topical carcinogenicity studies on hair dye ingredients or commercial formulations yielded no evidence for systemic toxicity or carcinogenicity, oral carcinogenicity studies on hair dye ingredients at oral doses up to the maximum tolerated dose (MTD) suggested that some ingredients are carcinogenic in rodents. Human systemic exposure to various (14)C-labelled oxidative hair dyes under conditions of use was below 1.0% of the amount applied. Conservative risk assessments suggested no or negligible cancer risk, including for ingredients that were found to be positive in oral carcinogenicity studies. The results of reproductive toxicity studies and epidemiological investigations suggested that hair dyes and their ingredients pose no risk of adverse reproductive effects. In conclusion, the weight of evidence suggests that consumer or professional exposure to hair dyes poses no carcinogenic or other human health risks.