title: Teratogenic potential of FD&C Red No. 3 when given by gavage.
abstract: FD&C Red No. 3 (erythrosine) is a commonly used food additive. As part of a series of studies on the potential fetal developmental effects of food colors, FD&C Red No. 3 was administered by gavage to pregnant Osborne-Mendel rats at daily dose levels of 15, 30, 100, 200, 400, or 800 mg/kg on days 0-19 of gestation. Control animals were given distilled water by gavage. On gestation day 20, the animals were euthanized and cesarean sections were performed. During the entire treatment period, feed consumption by the animals given 400 mg/kg doses was increased significantly; the increases in the animals given 30 or 800 mg/kg were of borderline significance. The only significant increase in maternal weight gain, on days 0-7 in the animals given 30 mg/kg, was considered a random occurrence. No dose-related changes were seen in maternal clinical findings, implantations, fetal viability, or fetal size (weight and length). No fetal terata were seen, and neither skeletal nor visceral development was affected. FD&C Red No. 3 was neither fetotoxic nor teratogenic at 800 mg/kg when given by gavage.
authors.affiliation: Center for Food Safety and Applied Nutrition, Food and Drug Administration, Washington, DC 20204.
authors.forename: T F
authors.initials: TF
authors.lastname: Collins
authors.forename: T N
authors.initials: TN
authors.lastname: Black
authors.forename: D I
authors.initials: DI
authors.lastname: Ruggles
mesh_terms: D000014:Abnormalities, Drug-Induced / Q000209:etiology*; D000818:Animals; D004923:Erythrosine / Q000008:administration & dosage / Q000633:toxicity*; D005260:Female; D005503:Food Additives / Q000008:administration & dosage / Q000633:toxicity*; D007441:Intubation, Gastrointestinal; D011247:Pregnancy; D011256:Pregnancy Outcome; D051381:Rats; D011919:Rats, Inbred Strains
chemical_list: D005503:Food Additives; D004923:Erythrosine