Toxicology and Carcinogenesis Studies of C. I. Disperse Blue 1. (CAS No. 2475-45-8) in F344/N Rats and B6C3F1 Mice (Feed Studies)

摘要

C.I. Disperse Blue 1, a component of several semipermanent hair dyes, was studied as a commercial grade product (minus lignosulfonate dispersants) containing approximately 50% 1,4,5,8-tetraamino-anthraquinone, 30% other compounds structurally related to 1,4,5,8-tetraaminoanthraquinone, and 20% water. C.I. Disperse Blue 1 was studied for toxicity and carcinogenicity in single-administration gavage, 14-day feed, 13-week feed, and 104-week feed studies. All studies used F344/N rats and B6C3F1 mice. Under the conditions of these feed studies of C.I. Disperse Blue 1, there was clear evidence of carcinogenicity for male and female F344/N rats as shown by the increased occurrence of transitional cell papillomas and carcinomas, of leiomyomas and leiomyosarcomas, and of squamous cell papillomas and carcinomas of the urinary bladder. Urinary bladder calculi were observed in the groups of rats in which urinary bladder neoplasms were increased. Positive associations existed between the presence of calculi and transitional cell neoplasms in male and female rats, leiomyomas or leiomyosarcomas (combined) in female rats, and squamous cell neoplasms in male rats.