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Safflower seeds which contains large amounts of conjugated linoleic acid and glyceride, are known to have effect on osteoporosis, bone fracture, and cholesterol metabolism. In this study, the 13-week repeated oral dose toxicity study of Safflower seeds was performed using F344 rats. In 14-day repeated dose study to determine the adequate dosage of safflower seeds administration, no other important changes were observed except statistically significant decreases in the mean absolute weights of the liver and the mean liver weight relative to body weight. It was dose-related finding at groups higher than 0.015 g/㎏ body weight (B.W.) in males and 0.045 g/㎏ B.W. in females. Based on preliminary test, safflower seeds was orally administered five times per week, weekday only to 5 groups of 6-week-old 10 male and 10 female F344 rats at dosage levels of 0.003, 0.016, 0.08, 0.4 and 2 g/㎏/day. The control group, also consisting of 10 males and 10 females, received the vehicle, 1% methylcellulose (MC), on a comparable regimen. One male and a female in the 0.4 g/㎏/day group, and a female in the 2 g/㎏/day group were found dead but the death could not be related to test article toxicity. No test article-related effect was observed on clinical signs and water consumption. For the 2 g/㎏/day males, there were significant decrease in body weight changes and food consumption from 10th week to study termination. The statistically significant decreases in the mean absolute weights of liver and the mean liver weight relative to body weight of the 0.003, 0.016 and 2 g/㎏/day group males and 0.003, 0.016 and 0.08 g/㎏/day females showed no dose related pattern and considered not to be test article related. There were no dose-related changes in hematology, biochemistry parameters, sperm morphology and vaginal cytology of all animals treated with safflower seeds. Gross and histopathological findings revealed no evidence of specific toxicity related to safflower seeds. These results suggest that no-observed adverse-effect level (NOAEL) of the test substance was considered to be 2 g/㎏/day for male and female rats under the conditions in this study.

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UCI(KEPA) : I410-ECN-0101-2009-510-015707020