Toxicity Profile for D & C Red 9 (1989)

Abstract

D & C Red 9 was of very low acute oral toxicity in rats and mice. On repeated oral administration to laboratory animals, the predominant toxic effects involved the spleen and blood. No convincing evidence of foetotoxicity or abnormal foetal development was seen in rats and rabbits fed low levels, but female fertility may have been reduced in a multigeneration rat study. On long-term feeding to rats it induced tumours of the spleen, but there was no convincing evidence of carcinogenicity in mice treated orally. No evidence of DNA damage was seen in rats treated orally and a range of genotoxicity screening assays in mammalian cells in culture generally gave no evidence of activity. Mutagenicity has been demonstrated in a bacterial Ames test.

A few cases of human skin sensitization have been reported, but a guinea-pig study suggested that impurities may have been responsible for this effect. D & C Red 9 produced horny thickening and blockage of secretory gland ducts when repeatedly applied to the rabbit ear. Repeated application of aqueous suspensions did not irritate the rabbit eye.