Final report on the safety assessment of Acid Violet 43.

Acid Violet 43 is an anthraquinone color that may be used as a colorant in cosmetic formulations that are hair dyes, colors, and coloring rinses. Batches of Acid Violet 43 that are certified to meet the United States Food and Drug Administration (U.S. FDA) specifications are termed Ext. D & C Violet No. 2. Hair dyes and colors containing Acid Violet 43 are considered coal tar ingredients and, as such, routinely bear a caution statement regarding potential skin irritation and instructions for determining whether the product causes skin irritation in any given individual. Expected concentrations of use are less than or equal to 1%. Impurities include anthracenedione derivatives, p-toluidine, and p-toluidine sulfonic acid, as well as heavy metals. Based on extensive safety test data, the U.S. FDA has established specifications (including limits on impurities) for Ext. D & C Violet No. 2 that allow its use in any cosmetic. It is the certified color (Ext. D & C Violet No. 2) that has been evaluated in the following safety tests. Oral toxicity tests do not demonstrate significant acute toxicity. In a short-term dermal toxicity study using guinea pigs and a subchronic dermal toxicity study using rabbits, no signs of systemic toxicity and no significant local skin reactions were noted. This ingredient was not genotoxic in bacterial assays, nor was it carcinogenic when applied to mouse skin at a 1% concentration. Accordingly, Acid Violet 43 was determined to be safe for use in hair dye formulations, when impurities are limited as follows: < or = 18% volatile matter (at 135 degrees C) and chlorides and sulfates (calculated as sodium salts); < or = 0.4% water-insoluble matter; < or = 0.2% 1-hydroxy-9,10-anthracenedione; < or = 0.2% 1,4-dihydroxy-9,10-anthracenedione; < or = 0.1% p-toluidine; < or = 0.2% p-toluidine sulfonic acids, sodium salts; < or = 1% subsidiary colors; < or = 20 ppm lead (as Pb); < or = 3 ppm arsenic (as As); < or = 1 ppm mercury (as Hg); and with > or = 80% total color.