The aromatic amine HC Blue No. 2 is used as a colorant exclusively in hair dyes. Current information indicates this ingredient is usually found in hair dyes at a concentration of ∼ 1.7%. Studies in volunteers in which HC Blue No. 2 at use concentrations was applied to the scalp, <0.1% was absorbed over a period of 30 days. National Toxicology Program oral feeding bioassays in rats and mice shows the ingredient to be relatively nontoxic. Animal studies indicate no evidence of dermal irritation, sensitization, or photosensitization, and no ocular irritation. Whereas HC Blue No. 2 is mutagenic, it was not carcinogenic in rats or in two mouse strains. Clinical data indicate minimal irritation and no sensitization. On the basis of the available data, it is concluded that HC Blue No. 2 is safe as used in cosmetic formulations (hair dyes).
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20.
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