Final Report on the Safety Assessment of Disperse Yellow 3

Abstract

Disperse Yellow 3 is a monoazo dye for which the exclusive cosmetic use has been in hair dyes. It is not, however, currently reported to be used. The toxicity of 87.6% pure Disperse Yellow 3 dye in mice and rats was found to include death; dose-related pituitary, thyroid, spleen, and kidney lesions; and carcinogenesis in male rats and female mice. Mutagenicity was observed in several systems, but the impact of activation was inconsistent. Clinical data suggest that some individuals exhibiting contact allergy to dyes in general may be sensitive to Disperse Yellow 3. Because there is an absence of data on the actual dermal absorption of this ingredient, the conclusion was reached that the available data are insufficient to support its safety. If the ingredient were found to be significantly absorbed, the conclusion would be that the ingredient is unsafe based on its carcinogenic potential. If the ingredient were found not to be absorbed, then data on impurities and on ocular toxicity would be needed to reach a more definitive conclusion regarding safety.

Keywords

Disperse Yellow 3 Monoazo dye Hair dye Carcinogenesis Allergy Dermal absorption.

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