Toxicology and Carcinogenesis Studies of HC Red No. 3 (2,-((4-Amino-2-Nitrophenyl)Amino)Ethanol) (CAS No. 2871-01-4) in F344/N Rats and B6C3F1 Mice (Gavage Studies)

摘要

Toxicology and carcinogenesis studies of HC Red No. 3 (97% pure), a semipermanent hair dye, were conducted by administering the chemical in corn oil by gavage for 105 weeks to groups of 50 male and 50 female F344/N rats and for 104 weeks to groups of 50 male and 50 female B6C3F1 mice. The dosage regimen used for rats was 0,250, or 500 mg/kg per day and for mice, 0,125, or 250 mg/kg per day. Doses were administered 5 days per week. In prior 13-week studies, these doses produced no signs of toxicity when administered 5 days per week. In the 2-year studies, the administration of HC Red No. 3 did not affect body weight gains of male or female rats or mice. Body weight gains by all groups of female mice were reduced because of a reproductive tract infection. Survival of male and female rats and mice was not reduced by administration of HC Red No. 3. The survival of female mice, including vehicle controls, was reduced relative to historical survival rates due to a reproductive tract infection. The infection, accompanied by weight loss, high mortality, and suppurative inflammation of multiple organs, was found in 36/50 vehicle control, 32/50 low dose, and 29/50 high dose female mice. Klebsiella pneumonia was isolated from infected tissues.