NTP Technical Report on the Toxicology and Carcinogenesis Studies of C.I. DirectBlue 218 (CAS No. 28407-37-6) in F344/N Rats and B6C3F1 Mice (Feed Studies)

摘要

Two year toxicology and carcinogenesis studies were conducted by administeringC.I. Direct Blue 218 in feed to groups of 60 male and female F344/N rats and B6C3F1 mice at doses 0, 1,000, 3,000, or 10,000 ppm. Under the conditions of these 2-year feed studies, there was some evidence of carcinogenic activity of C.I. Direct Blue 218 in male F344/N rats based on the occurrence of pharyngeal neoplasms. Squamous cell neoplasms of the forestomach may have been chemical related. There was no evidence of carcinogenic activity of C.I. Direct Blue 218 in female F344/N rats given 1,000, 3,000, or 10,000 ppm. There was clear evidence of carcinogenic activity of C.I. Direct Blue 218 in male and female B6C3F1 mice based on increased incidences of hepatocellular adenomas and carcinomas.