Toxicity Profile for Annatto extracts (1991)

Abstract

Annatto extracts were of low acute oral toxicity in rats. Studies involving repeated oral administration (some unpublished and probably none comprehensive in nature) did not convincingly demonstrate toxic effects in the rat, mouse, dog or pig. Effects on reproduction were evidently not seen in multigeneration feeding studies in rats. Limited feeding, dermal and injection studies have given no convincing evidence of carcinogenicity in rats or mice. Annatto extracts have evidently given contradictory results in Ames bacterial tests. Chromosome damage was apparently seen in mammalian cells in culture, but only when exposed to very high concentrations. This activity was not confirmed in rats treated with annatto extracts. Ingestion of annatto extracts may provoke a recurrence of symptoms in individuals with pre-existing skin complaints or food allergy symptoms.