Teratological Evaluation Of Fd And C Red No 2-A Collaborative Government-Industry Study .5. Combined Findings And Discussion

Because of recent studies indicating possible embryolethality and teratogenicity of FD&C Red No. 2, an ad hoc committee was convened by the Food and Drug Administration to consider these questions. The committee suggested a collaborative study by three laboratories [Food and Drug Administration (FDA), Industrial Bio‐Test Laboratories (IBT), and National Center for Toxicological Research (NCTR)J in which Red No. 2 was given at 200 mg/kg body weight, by gavage during days 0–19, 6–15, or 7–9 of gestation. FD&C Red No. 2 was also given at the same dose level via water bottle. Appropriate controls were utilized. FDA used Osborne‐Mendel strain rats, IBT used Charles River, and NCTR used both strains. No significant increases in skeletal or visceral abnormalities were seen. No significant increase in resorptions was seen in the Osborne‐Mendel strain, but the Charles River strain at IBT showed a significant increase in litters with two or more resorptions after dams had been given 200 mg/kg at 0–19 days of gestat...