Oral toxicity studies of Ethyl Acetate Polyherbal Extract Gel Formulation Obtained from Berries and Flaxseed (EAPEG-BF) in Wistar Rats

Berries family and flaxseed have been used in ethnomedicinal practice for the treatment of various disorders and different ailments. Despite its beneficial uses, no studies on its polyherbal formulated gel combination toxicity potential have been reported. The present research study was designed to evaluate the acute oral toxicity (14 days) and sub-acute oral toxicity (repeated dose) study (28 days) of ethyl acetate polyherbal extract gel formulation obtained from berries and flaxseed according to OECD TG No. 423 and 407. Male Wistar Rats were taken for toxicological screening of acute and sub-acute oral toxicity as per OECD guidelines of ethyl acetate polyherbal extract gel formulation obtained from berries (Rubus idaeus, Vaccinium macrocarpon, Vaccinium angustifolium, Fragaria x ananassa) and flaxseed (Linum usitatissimum) at doses of 500 mg/kg, 1000 mg/kg, 2000 mg/kg and 5000 mg/kg b.w. p.o. The rats were orally treated and screened for various behavioural patterns and the clinical signs of toxicity after administration. In sub-acute oral toxicity screening, the highest dose of 5000 mg/kg was selected for repeated dose toxicity for 28 days. The data of the results showed that no toxic symptoms were observed up to the dose of 2000 mg/kg body weight. When testing is required a dose of 5000mg/kg, only one step. There was no toxic symptoms and mortality were observed up to the dose of 2000 mg/kg body weight during the 14 days of the observation. There is no visible change in the food intake and body weight when compared to control. The toxicological study revealed that LD50 of the extract formulation gel was greater than 5000 mg/kg body weight p.o. In comparison to the control group, there were no significant changes in levels of biochemical parameters and haematological parameters. It was concluded from the data obtained in this research study that though LD50 is greater than 5000 mg/kg body weight; but there was no occurrence of observed adverse effects levels appeared in the liver, kidney, lipid profile and blood parameters.