Toxicity Profile for Polysorbate 20 (1989)

Abstract

Polysorbate 20 was a skin irritant in dermatitis patients but was reported not to induce irritant responses when applied to the intact skin of health volunteers. It produced, at worst, minimal irritation in the eyes of rabbits. Only a small number of cases of skin sensitization have been reported in humans, although a moderate to strong sensitizing potential was seen in guinea-pigs treated by intradermal injection. A low acute oral toxicity was demonstrated in laboratory animals. On repeated intravenous administration, effects on the liver, spleen and kidneys were seen in premature babies exposed to polysorbate 80:polysorbate 20 mixture and some fatalities occurred. In rats and hamsters, repeated oral exposure to polysorbate 20 produced damage at a range of sites including the gastro-intestinal tract, liver and kidneys. In preliminary studies, reproductive toxicity induced in rats and mice by intraperitoneal injections during pregnancy was not seen in rats given the polysorbate 20 either orally or dermally. Polysorbate 20 probably induced a skin tumour in a mouse treated dermally. In oral studies in rats and skin-painting studies in mice, it increased the yield of tumours induced by established carcinogens.