Final Report on the Safety Assessment of Disperse Violet

Abstract

Disperse Violet 1 is a diamino-anthraquinone dye that is used as an ingredient in both semi-permanent and permanent hair coloring formulations at concentrations at or below 1%. In acute oral toxicity tests, Disperse Violet 1 was practically nontoxic. In a subchronic feeding study, no adverse clinical or untoward pathological changes were found. Disperse Violet 1 was practically nonirritating in ocular studies at a concentration of 5.0%. A formulation containing Disperse Violet 1 was nonirritating to the skin. In Ames assays using concentrations of Disperse Violet 1 that ranged from 10 to 1000 μg/plate, Disperse Violet 1 was not mutagenic. In one other Ames assay at concentrations ranging from 100 to 2000 μg/plate, some mutagenic activity of Disperse Violet 1 was seen both without and with metabolic activation. In a long-term test, a hair dye formulation containing 0.033% Disperse Violet 1, dermally applied, was not carcinogenic. At a concentration of 5%, Disperse Violet 1 was not a human skin irritant. Hair dyes containing Disperse Violet 1 are exempt from the principal adulteration provision and from the color additive provisions in Sections 601 and 706 of the Federal Food, Drug, and Cosmetic Act of 1938 when cautionary statements and skin patch test instructions are conspicuously displayed on the labels. On the basis of the animal and clinical data presented in this report, it is concluded that Disperse Violet 1 is safe as a cosmetic ingredient in the present practices of use and concentration.