Multigeneration study of FD & C Red No. 3 (erythrosine) in Sprague-Dawley rats.

Sprague-Dawley rats received dietary admixtures containing 0.0, 0.25, 1.0 or 4.0% FD & C Red No. 3 (25 rats/sex/group) in a three-generation reproduction study. Each generation was bred twice and breeders for subsequent generations were selected after weaning of the second mating from each generation. There were no compound-related adverse effects on reproductive indices and no gross anomalies were observed. The body weights of parents and pups were significantly reduced (P less than 0.05) in all generations at the 4.0% dietary concentration. Maternal body-weight gain during gestation was frequently reduced in the 1.0 and 4.0% groups. The conservative no-observed-adverse-effect level established in this study was 0.25% (approximately 149 and 255 mg/kg body weight/day for males and females, respectively).