Toxicity Profile for Polysorbate 60 (1989)

Abstract

Polysorbate 60 has exhibited a weak skin sensitizing potential in man and may be a weak skin irritant. In rabbits, it irritated the skin and eyes. A low acute oral toxicity was indicated in rats and mice. On repeated oral administration the principal sign of toxicity in laboratory animals was diarrhoea. Effects on reproduction were only seen at high oral doses in rats. Limited feeding studies in rats gave no evidence of carcinogenicity although polysorbate 60 induced local tumours in mice treated dermally. In studies involving oral administration or local application it enhanced the tumour yields of established carcinogens in rodents. A range of limited genotoxicity studies has generated no convincing evidence of activity.

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