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A 13-week subchronic toxicity study of hexyl acetate in SD rats

Toyoda T1, Cho YM1, Matsushita K1, Tachibana S2, Senuma M2, Akagi JI1, Ogawa K1.

Author information:
1. Division of Pathology, National Institute of Health Sciences, 3-25-26 Tonomachi, Kawasaki-ku, Kawasaki, Kanagawa 210-9501, Japan.
2. Hatano Research Institute, Food and Drug Safety Center, 729-5 Ochiai, Hadano, Kanagawa 257-8523, Japan

PMID: 31402808 PMCID: PMC6682557

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Hexyl acetate (CAS No. 142-92-7) is a naturally occurring ester compound that has a fruity odor. Despite its frequent use as a nature-identical flavoring agent, there are limited repeated dose toxicity data for hexyl acetate. Here we performed a 13-week subchronic toxicity study of hexyl acetate in male and female Crl:CD(SD) rats under GLP regulations. Hexyl acetate was given orally by gavage at doses of 0, 100, 300, or 1,000 mg/kg/day using corn oil as the vehicle. No significant toxicological changes in general condition, body weights, food intake, ophthalmology, hematology, organ weights, and histopathological findings were observed in any groups. Urinalysis revealed occult blood in two male animals treated with 1,000 mg/kg/day hexyl acetate, and one showed red blood cells in the urine sediment. Furthermore, blood biochemistry showed a significant increase in inorganic phosphorus levels in males treated with 1,000 mg/kg/day hexyl acetate. These results indicated that the no-observed-adverse-effect level (NOAEL) of hexyl acetate was 300 mg/kg/day for males and more than 1,000 mg/kg/day for females.