Study on the developmental toxicity of β-ionone in the rat

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β-ionone (BIO) is used in fragrances, toiletries and non-cosmetic products, and as a flavor food additive. Notwithstanding the widespread human exposure, there are limited data on the reproductive toxicity of BIO. This study evaluated the developmental toxicity of BIO (0, 125, 250, 500 and 1000mg/kg body weight/day) given orally to rats on days 6–15 of gestation (GD6–15). C-section was on GD21 and implantations, living and dead fetuses and resorptions were recorded. Fetuses were weighed, and examined for external abnormalities and skeleton and visceral anomalies. The embryotoxicity of a single oral dose of BIO (1000mg/kg body wt) given on GD11 was evaluated as well. At the highest dose, BIO reduced weight gain and produced chromodacryorrhea and other signs of toxicity. BIO did not increase the frequency of malformations nor did it retard fetal growth. Nonetheless, BIO decreased the pregnancy rate in the group of females exposed on GD6–15, and increased the resorption rate in those treated on GD11 only. In conclusion, except for a higher embryolethality at a maternally toxic dose, BIO caused no embryotoxic effect over the dose range tested and the study NOAEL for maternal and developmental toxicity was 500mg of BIO/ kg of body weight/day.HIGHLIGHTSβ-ionone in oral doses ≤500mg/kg body wt/day on GD 6–15 caused no maternal or developmental toxicity in Wistar rats.The only embryotoxic effect of β-ionone 1000mg/kg body wt/day in rats treated on GD 6–15 was an increased embryolethality.A single high dose of BIO on GD11 caused maternal toxicity and, except for early embryo deaths, no developmental toxicity.Results suggest that BIO is unlikely to pose health risks to the unborn child in any realistic exposure scenario.

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