Lifetime toxicity/carcinogenicity study of FD & C Red No. 3 (erythrosine) in mice.

Charles River CD-1 mice were fed FD & C Red No. 3 in the diet at levels of 0.3, 1.0 and 3.0% in a long-term toxicity/carcinogenicity study. Each group consisted of 60 males and 60 females. Two concurrent control groups each of 60 males and 60 females received the basal diet. Maximum exposure was 24 months. The no-adverse-effect levels established in this study were 3.0% (an average intake of 4759 mg/kg/day) for male mice and 1.0% (1834 mg/kg/day) for female mice.