Ford, G.P., Gopal, T., Grant, D., Gaunt, I.F., Evans, J.G., & Butler, W.H. 1987 Chronic toxicity/carcinogenicity study of carmine of cochineal in the rat.. Food and Chemical Toxicity 25(12): 897-902.

Notes: Carmine (a red dye obtained by aqueous extraction from the crushed air-dried bodies of Dactylopius coccus) was fed continuously to groups of 54 males and 54 females at dietary levels providing 50, 150 or 500 mg/kg body weight/day for up to 109 weeks. As a control, groups of 90 males and 90 females were fed the basal diet for the same period. The rats were derived from parents fed the same dietary levels for 60 days before mating and throughout pregnancy and were thus potentially exposed in utero. There were no adverse effects upon survival, growth or intakes of food and water. No changes associated with treatment were found during the periodic measurement of haematology or renal function, or in the serum chemistry or organ weights at the end of the study. Tumor incidence was not affected, and variations in the distribution of the non-tumor pathology were not considered to be due to treatment. It was concluded that carmine administered to rats in utero and for up to 109 weeks is not carcinogenic and that the no-untoward-effect level is 500 mg carmine/kg body weight/day.