Acute (mouse and rat) and short-term (rat) toxicity studies on Ponceau 4R

Abstract

Acute toxicity studies in rats and mice and a short-term feeding study in rats have been carried out on Ponceau 4R. The acute intraperitoneal LD 50s in male and female rats were 0·6 and 2·6 g/kg respectively. Corresponding values in mice were 1·9 and 1·6 g/kg. The oral LD 50 exceeded 8 g/kg in both species. Feeding of Ponceau 4R to rats at dietary levels of 0·0 (control), 0·5, 1·0 and 2·0% for 90 days evoked no adverse effect on the appearance or condition of the animals. Growth and food consumption were unaffected by treatment. Haematological indices and levels of serum glutamic-oxaloacetic and glutamic-pyruvic transaminases showed no change at levels up to 1% but at the 2% level, especially in females, a slightly depressed red cell count was associated with decreases in haemoglobin concentration and haematocrit value. Serum transaminase activity was also elevated at the highest level. No departure from normality was revealed in the renal function tests and organ weight measurements. The types and incidence of histological lesions were comparable in control and test groups. A no-effect level of 1% Ponceau 4R was established in the diet of rats for 90 days, a level equivalent to 500 mg/kg/day.