Dominant lethal mutagenicity study on hair dyes

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Abstract
A dominant lethal mutagenicity study was performed in rats with the following chemicals that may be used to dye hair: 2‐nitro‐p‐phenylenediamine, 4‐nitro‐o‐phenylenediamine, m‐phenylenediamine, o‐phenylenediamine, p‐phenylenediamine, p‐toluenediamine, 2,4‐diaminoanisole, 2,5‐diaminoanlsole, 2‐amino‐4‐nitrophenol, 2‐amino‐5‐nitrophenol, and 4‐amino‐2‐nitrophenol. The compounds were administered intraperitoneally three times weekly for 8 weeks to groups of 20 sexually mature Charles River CD male rats at a dose of 20 mg/kg. This amount of dye is an enormous exaggeration of the human exposure from brief monthly topical application of a hair color product containing 2 g (40 mg/kg) or less total dye. There was no evidence of an increase in postimplantation fetal loss which could indicate a dominant lethal effect. Included are data on the acute toxicity of the dyes by various routes of administration in different vehicles.