Acute (mouse and rat) and short-term (rat) toxicity studies on chocolate brown HT

Abstract

Acute toxicity studies in rats and mice and a short-term study in rats have been carried out on Chocolate Brown HT. The acute intraperitoneal LD 50 in mice was estimated to be 220 mg/kg for females and 300 mg/kg for males and in rats 375 mg/kg for both sexes. The oral LD 50 exceeded 2 g/kg in both species. Feeding of Chocolate Brown HT to rats at dietary levels of 0·0, 0·5, 1·0 and 2·0% for 12 wk evoked no adverse effect on the appearance or condition of the animals. Growth retardation, not associated with a diminished food intake, was evident in males at the 1 and 2% dietary levels. Haematological examinations conducted at wk 6 and 12 and liver and kidney function tests made at wk 12 revealed no departure from normality apart from non-significant reductions of red cell count and haematocrit in males at the 2% level and a mild degree of renal dysfunction in both sexes at the two highest dietary levels. The principal findings, mainly at the 2% level, were significant increases in the weights (relative to body weight) of the brain and adrenal in males, the spleen and kidneys in both sexes, and the ovaries. The types and incidence of pathological lesions were comparable in control and test groups. A no-effect level was established of 0·5% of Chocolate Brown HT in the diet of rats for 12 wk.