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EC number: 305-962-8 | CAS number: 95370-96-0
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The test substance Epoxidised Soybean Oil (ESBO) was given daily 7 times a week to three groups of 28 F0 male and 28 F0 female Sprague-Dawley rats by gavage at the dose levels of 100, 300 and 1000 mg/kg bw/day. The F0 control animals (28 males and 28 females) received the vehicle Soybean Oil (SBO).
After 71 days of treatment in males and 15 days of treatment in females; the F0 male and female rats were paired. Treatment was continued in females during the mating and pregnancy and lactation periods until day 21 post-partum and in males during the mating period until day 21 post-partum of F1 litters.
F0 animals were observed daily for clinical signs. Food consumption and body weight were measured at designated intervals. The females were allowed to deliver normally. The F1 litters were examined daily for clinical signs, viability, physical, and reflex development until day 21 post-partum. Pup body weights were recorded on days 1. 4, 7, 14 and 21 post-partum.
About 24 hours after the last administration, haematology and blood chemistry investigations were performed in 5 males and 5 females of each group. At the end of the study, macroscopic examination of all F0 males and females and F1 pups was performed. In all the parents, reproductive organs and macroscopic lesions were sampled and additionally in 5 males and 5 females of each group ileum, kidneys and liver were sampled. Microscopic examination of the reproductive organs was performed in all animals of the control and 1000 mg/kg bw/day groups and in animals suspected of infertility, died or sacrificed in the 100 and 300 mg/kg bw/day groups. In addition the liver of one male of the 1000 mg/kg bw/day group and of the control group were also examined microscopically.
Clinical parental data – no treatment-related mortalities or clinical signs were observed. The mean food consumption and body weight gain of males and females were similar in the control and treated groups. The variations of haematologic or blood chemistry parameters were not of toxicological importance. The macroscopic and microscopic examination of the animals did not reveal any changes attributed to the treatment.
Reproductive data - the mating and fertility indices of males or female was similar in the control and treated groups.
Litter data – the gestation index and the mean duration of gestation was similar in all groups. The live birth index was 100 % in all groups. The viability indices on day 4 and day 21 post-partum, the physical and reflex development of pups and the mean pup body weight were similar in the control and treated groups.
Conclusion – the test substance ESBO administered daily by oral route (gavage) to male and female Sprague-Dawley rats at the 100, 300 and 1000 mg/kg bw/day dose levels 71 days before mating in males and 15 days before mating in females until day 21 post-partum of F1 litters did not induce any toxic effects in parent males and females, did not disturb their capacity of reproduction and did not impair the development of the F1 offspring/
Under the conditions, the highest tested dose of 1000 mg/kg bw/day was found to be the NOEL.
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