Toxicology and Carcinogenesis Studies of C.I. Basic Red 9 Monohydrochloride (Pararosaniline) (CAS No. 569-61-9) in F344/N Rats and B6C3F1 Mice (Feed Studies)

摘要

Under the conditions of these 2-year feed studies, there was clear evidence of carcinogenicity of C.I. Basic Red 9 monohydrochloride for male and female F344/N rats and for male and female B6C3F1 mice. In male rats, C.I. Basic Red 9 monohydrochloride caused squamous cell carcinomas, trichoepitheliomas and sebaceous adenomas of the skin, subcutaneous fibromas, thyroid gland follicular cell adenomas and follicular cell carcinomas, Zymbal gland carcinomas, and hepatocellular carcinomas. In female rats, C.I. Basic Red 9 monohydrochloride caused subcutaneous fibromas, thyroid gland follicular cell adenomas or carcinomas (combined), and Zymbal gland carcinomas. In male mice, C.I. Basic Red 9 monohydrochloride caused hepatocellular carcinomas. In female mice, C.I. Basic Red 9 monohydrochloride caused hepatocellular carcinomas and adrenal gland pheochromocytomas or malignant pheochromocytomas (combined). Exposure to C.I. Basic Red 9 monohydrochloride also may have been related to increased incidences of mammary gland tumors in female rats and hematopoietic system tumors in female mice.