indigo-carmine and Body-Weight

Charles River CD rats (20 pregnant rats/group) received by gavage on days 6-15 of gestation 0.5% Methocel (controls, A, B and C), retinoic acid at 7.5 mg/kg/day or FD & C Blue No. 2 in doses of 25, 75 or 250 mg/kg/day. Pregnant Dutch belted rabbits (ten pregnant does/group) received by gavage on days 6-18 of gestation 0.5% Methocel (controls A, B and C), thalidomide at 150 mg/kg/day or FD & C Blue No. 2 in doses of 25, 75 or 250 mg/kg/day. All animals were observed twice daily during gestation for signs of toxicity. The animals were killed 1 day before term and appropriate maternal and foetal parameters were evaluated. There were no consistent, significant compound-related adverse effects on any of these parameters. Foetal malformations occurred in both positive control groups. Under the conditions of this study, FD & C Blue No. 2 did not exert any teratogenicity or other developmental toxicity in either rats or rabbits.

Topics: Animals; Body Weight; Female; Fetus; Gestational Age; Indigo Carmine; Indoles; Pregnancy; Rabbits; Rats; Teratogens

FD & C Blue No. 2 was fed to rats in the diet in a long-term toxicity/carcinogenicity study. The study included an in utero phase in which the compound was administered to groups of 60 male and 60 female Charles River CD albino rats at levels of 0.5, 1.0 and 2.0%. Two concurrent control groups, each containing 60 rats of each sex, received the basal diet. After random selection of the F1 animals, the long-term phase was initiated at the same dietary levels, with 70 rats of each sex in each dose group and in each of two control groups. Maximum exposure was 30 months. No consistent compound-related biologically adverse effects were noted. There were random statistically significant differences from the controls with respect to body weight, food consumption and clinical chemistry tests. Food consumption by the test groups showed a dose-related increase. This was probably due to the non-nutritive character of the colouring. A statistically significant increase in gliomas in the high-dose male rats was not found to be biologically significant, since none of the criteria for determining the neurocarcinogenic potential of chemical substances was met. The overall brain-tumour incidence in this study was within the range typical for 2-yr-old CD rats. Under the conditions of this study, FD & C Blue No. 2 did not produce evidence of any toxicity, including carcinogenicity.

Topics: Animals; Body Weight; Brain Neoplasms; Dose-Response Relationship, Drug; Eating; Female; Fetus; Glioma; Indigo Carmine; Indoles; Male; Mammary Neoplasms, Experimental; Neoplasms, Experimental; Organ Size; Pregnancy; Rats

Charles River CD-1 mice were fed FD & C Blue No. 2 in the diet levels of 0.5, 1.5 and 5.0% 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 23 months. No consistent compound-related or statistically significant biologically adverse effects were noted.

Topics: Animals; Body Weight; Dose-Response Relationship, Drug; Female; Indigo Carmine; Indoles; Male; Mice; Mice, Inbred Strains; Neoplasms, Experimental

Topics: Adenoma; Animals; Blood Cell Count; Body Weight; Diet; Female; Indigo Carmine; Indoles; Lung Neoplasms; Male; Mice; Organ Size; Time Factors