Carcinogenesis Bioassay of D and C Red No. 9 (CAS No. 5160-02-1) in F344/N Rats and B6C3F1/N Mice (Feed Study)

摘要

A carcinogenesis bioassay of D & C Red No. 9, pigment used in topical drugs and cosmetics, was conducted by feeding diets containing 1,000 or 3,000 ppm of the test substance (89.8% pure) to groups of 50 F344 rats of either sex for 103 weeks. Similar groups of 50 B6C3F1 mice received diets containing 1,000 or 2,000 ppm of the test substance for 103 weeks. Groups of 50 untreated rats and mice of either sex served as controls. Under the conditions of this bioassay, D & C Red No. 9 was carcinogenic for male F344 rats causing an increased incidence of sarcomas of the spleen and a dose-related increase in neoplastic nodules of the liver. D & C Red No. 9 was not considered to be carcinogenic to female F344 rats, although the increased incidence of neoplastic nodules of the liver may have been associated with administration of the test chemical. D & C Red No. 9 was not carcinogenic for B6C3F1 mice of either sex.