Preclinical assessment of safety profile of hydro-alcoholic extract of Entada phaseoloides L. Merr seed kernels

Entada phaseoloides L. Merr is used as folk medicine for the management of diabetes mellitus, stress, hyperli-pidaemia, stomachache, and oedema. The objective of the present study is to evaluate the safety of character-ized hydro-alcoholic extract of E. phaseoloides seed kernels (HAEP) in rodents. Phytochemical investigations of HAEP suggest the presence of alkaloids, carbohydrates, tannins, flavonoids, glycosides, and terpenoids. HPTLC fingerprint of HAEP was developed for quality control. An acute oral toxicity study was conducted in accordance with the OECD Guidelines by 'up and down' method, using the limit test at 2000 mg/kg body weight in mice, and was observed for 14 days. In sub-chronic toxicity, HAEP was orally administered to groups of male and female Wistar rats (n = 10/group/sex) at doses of 100, 300 and 1000 mg/kg, over a period of 90 days. In acute toxicity, there was no mortality and no behavioural signs of toxicity at the limit test dose (2000 mg/kg b. w.). In sub-chronic toxicity, repeated administration of HAEP for 90 days had no significant difference in the body weight and organ weight. There were no changes in the serum biochemical, haemato-logical parameters and urine analysis on prolonged oral consumption of HAEP. According to the study, the no-observed-adverse-effect level (NOAEL) of HAEP in the 90-day repeated dose toxicity study in rats was 1000 mg/kg. The histopathologic examination did not show any differences in vital organs. Based on our findings, HAEP, at dosage level up to 1000 mg/kg b. w., is non-toxic and safe for long-term consumption.(c) 2023 Published by Elsevier B.V. on behalf of SAAB.