Toxicity Profile for Polysorbate 80 (1992)

Abstract

Polysorbate 80 was an irritant when applied repeatedly to the skin of rabbits; single instillation in the eye of rabbits produced only minimal irritation. A few cases of possible skin sensitization have been recorded in man; oral doses have been shown to exacerbate the symptoms of patients with chronic nasal inflammation. Acute studies in laboratory animals indicated a low oral and injection toxicity. On repeated intravenous administration, effects on the liver, spleen and kidneys were seen in premature babies exposed to a 9:1 polysorbate 80:polysorbate 20 mixture and there were some deaths. Limited clinical trials found no overt toxic effect when polysorbate 80 was given orally for periods of a few days in infants or for several months up to 4 yr in volunteers. Inadequate long-term dietary studies in rats indicated a low toxicity but a study involving repeated administration by stomach tube found effects on the heart, liver, kidney and blood. Liver injury was seen in mice treated orally. The limited oral studies in rats and mice found no evidence of carcinogenicity. Polysorbate 80 probably induced a skin tumour in a mouse treated repeatedly by the dermal route. In oral and skin painting studies in mice, it increased the yield of tumours induced by established carcinogens. Limited injection studies in mice generated no evidence of genotoxic potential. A range of other limited in vitro assays also gave negative results. Reproductive studies in rats and mice treated orally have reported no marked adverse effects.

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