Final Report on the Safety Assessment of Disperse Blue 71

Abstract

Disperse Blue 7 is an anthraquinone dye used in cosmetics as a hair colorant in five hair dye and color products reported to the Food and Drug Administration (FDA). Hair dyes containing Disperse Blue 7, as "coal tar" hair dye products, are exempt from the principal adulteration provision and from the color additive provision in sections 601 and 706 of the Federal Food, Drug, and Cosmetic Act of 1938 when the label bears a caution statement and "patch test" instructions for determining whether the product causes skin irritation. Disperse Blue 7 is also used as a textile dye. The components of Disperse Blue 7 reportedly include Disperse Turquoise ALF Granules, Disperse Turquoise LF2G, Reax 83A, Tamol SW, and Twitchell Oil. No data were available that addressed the acute, short-term, or chronic toxicity of Disperse Blue 7. A mouse lymph node assay used to predict the sensitization potential of Disperse Blue 7 was negative. Although most bacterial assays for genotoxicity were negative in the absence of metabolic activation, consistently positive results were found with metabolic activation in Salmonella strains TA1537, TA1538, and TA98, which were interpreted as indicative of point mutations. Studies using L5178Y mouse lymphoma cells appeared to confirm this mutagenic activity. Mammalian assays for chromosome damage, however, were negative and animal tests found no evidence of dominant lethal mutations. Cases reports describe patients patch tested with Disperse Blue 7 to determine the source of apparent adverse reactions to textiles. In most patients, patch tests were negative, but there are examples in which the patch test for Disperse Blue 7 was positive. In general, anthraquinone dyes are considered frequent causes of clothing dermatitis. The Cosmetic Ingredient Review Expert Panel determined that there was a paucity of data regarding the safety of Disperse Blue 7 as used in cosmetics. The following data are needed in order to arrive at a conclusion on the safety of Disperse Blue 7 in cosmetic products: (1) methods of manufacture, including clarification of the relationship between Disperse Blue 7 and Disperse Turquoise ALF and Disperse Turquoise LF2G mixed with Reax 83A, Tamol SW, and Twitchell Oil; (2) analytical methods by which Disperse Blue 7 is measured; (3) impurities; (4) concentration of use as a function of product type; (5) confirmation that this is a direct hair dye; and (6) clarification of genotoxicity study results (e.g., Disperse Turquoise ALF and Disperse Turquoise LF2G were genotoxic in bacteria - what is the specific relation to Disperse Blue 7? Disperse Blue 7 at 60% purity was genotoxic in bacteria - is the other 40% the inert Reax 83A, Tamol SW, and Twitchell Oil?). Until such data are provided, the available data are insufficient to support the safety of Disperse Blue 7 as a hair dye ingredient in cosmetic formulations.