PRECLINICAL ACUTE AND REPEATED DOSE TOXICITY OF PUERARIA TUBEROSA (PTWE) ON CHARLES FOSTER RATS

Here we have carried out the acute and repeated dose toxicity study on tubers of Pueraria tuberosa water extract (PTWE). For acute toxicity study, rats were orally administered a single dose of 2000 and 5000 mg/kg body weight of PTWE. For repeated dose toxicity study on rats in one set, the different doses were given daily up to 28 days to make general observation and mortality rate. In another set of experiment, group of different doses were sacrificed on 7, 14, 21 and 28 days to assess the biochemical and histological changes. The selected doses were 250, 500, 1000 and 2000 mg/kg b.w. To evaluate it, we have used OECD guidelines 425 and 407 respectively, in both acute and repeated oral toxicity. No adverse effect was observed in all the rats, up to 14 days after treatment with single doses of 2000 and 5000 mg/kg b.w. Slight increase in salivation, mild diarrhea and letharginess were observed on 7^th day at dose of 500 and 1000mg/kg, but recovered on 14^th day and remain normal up to 28^th day. There was 100% survival up to 28 days in rats treated with dose of 1000 mg/kg b.w., but at dose of 2000 mg/kg b.w., mortality was 17 % on 7^th day, 50% on 14^th days & 100% on 21 days. Based on these datas, the LD₅₀ was calculated to be > 5000mg/kg b.w. After considering all the toxic information on PTWE, we could elaborate all its previously mentioned medicinal properties in further clinical studies.