Acute and long term safety evaluation of grape seed extract and zinc containing multivitamin-mineral nutritional food supplement in rodents

To study the acute and sub-chronic toxicity associated with potential Zincovit tablets with grape seed extract among rats and mice. For acute toxicity in adult female Sprague-Dawley rats and Balb-c mice, the Acute Toxicity Class method (OECD 423 guideline) was employed. Animals were observed individually after dosing daily for a total of 14 days. Sub chronic toxicity was investigated in normal control (2% gum acacia, 1 ml/kg) and Zincovit tablets with grape seed extract at 50, 500 and 1250 mg/kg/day individually for 3 months in adult Sprague-Dawley female rats (4 groups, n= 6). Clinical signs, hematological and biochemical parameters were assessed. During the acute toxicity study, there were no behavioral changes or mortality observed even at 2000 mg/kg of Zincovit tablet with grape seed extract among rats and mice. There was no significant change in their body weight. LD50 cut-offfor mice and rat was found to be above 5000 mg/kg and the drug came under the category 5 according to Globally Harmonized Classification System (OECD 423 guidelines). During the 90 days of sub-chronic toxicity study, treatment with combined formulation of grape seed extract and Zincovit tablets among Sprague-Dawley rats, the lowest-observed-adverse-effect levelsand no-observed-adverse-effect levels was observed as 500 mg/kg and 50 mg/kg respectively. The present study revealed that the single combined formulation of grape seed extract and Zincovit tablet is the potential functional nutritional food supplements that could offer a novel therapeutic opportunity against oxidative stress associated disorders in Sprague-Dawley rats.