| Abstract
| - To assess the safety of grape seed extract with less than 5.5% catechin monomers (IH636), 4 groupsof male and female Sprague−Dawley rats were provided grape seed extract in the diet at levels of0 (control), 0.5, 1.0, or 2.0% for a period of 90 days. All animals survived the duration of the study,and no significant changes in clinical signs, hematological parameters, organ weights, ophthalmologyevaluations, or histopathological findings were observed. A significant increase in food consumptionwas observed in male and female rats provided the grape seed extract diets compared to that of thecontrol rats, especially in male rats consuming 2.0% grape seed extract. This effect was notaccompanied by increases in body weight gains. Grape seed extract appeared to increase the insolublefraction of the diet. Male rats in the high-dose group exhibited decreased serum iron levels anddecreased serum iron/total iron binding capacity ratio compared to those of the controls, although allvalues were within historical ranges for Sprague−Dawley rats. In conclusion, administration of thegrape seed extract IH636 to male and female Sprague−Dawley rats in the feed at levels of 0.5, 1.0,or 2.0% for 90 days did not induce any significant toxicological effects. Keywords: Grape seed extract; Vitis vinifera; flavonoid; proanthocyanidin; polyphenols; oral toxicity;rats
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