Sunset Yellow FCF (1995)
Abstract
Sunset Yellow in petrolatum or in aqueous solutions was not irritant to human or rabbit skin and was minimally irritant to the rabbit eye. No reports of contact dermatitis induced by Sunset Yellow were identified, although patients apparently sensitized by para-phenylenediamine reacted when patch tested with Sunset Yellow. Oral provocation tests have indicated that Sunset Yellow can provoke various symptoms, principally skin complaints and asthmatic reactions, in a small percentage of those exposed. The acute toxicity in rodents was low by both oral and intraperitoneal routes. Studies in a variety of laboratory animals involving repeated oral or dermal exposure failed to generate any consistent indication of specific target organ toxicity. No foetal malformations were observed on oral administration to rats or rabbits but decreased pup survival and birth weights were reported in rats. There was no convincing evidence of carcinogenic activity in a number of long-term feeding studies in rats and mice or in a limited skin-painting study in mice. Western studies have, in general, found little evidence that Sunset Yellow possesses significant genotoxic potential either when given orally or by injection to rodents, in mammalian cells in culture, or in bacterial assays, including a large number of Ames tests.
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