Safety Assessment of Tuberous Rhizome of Kaempferia rotunda L. By Acute and 28-days Repeated Dose Toxicity Studies

The acute and 28-days repeated dose toxicity studies of the ethanolic extract of rhizome, tuber, rhizome fractions and the essential oil of Kaempferia rotunda L. were performed on Wistar albino rats to substantiate the tribal claims of its use as a safe wound healing and anti-ulcerogenic drug. The extracts, the essential oil and the rhizome fractions (petroleum ether, chloroform, methanol, aqueous and the acetone-chloroform) of K.rotunda were found to be non toxic or non corrosive in the acute dermal toxicity studies when tested topically on the skin of the animal and were safe for use up to 20 % (w/w) /day. The individual acute oral toxicity of the extracts and fractions were carried out at a single test dose of 2000 mg/kg p.o. and there was no treatment related mortalities or toxic signs observed in any of the treated animals. Further, the 28-days repeated dose study (250, 500 and 1000 mg/kg p.o. / day) with a post trial 14-day no treatment observation period at high dose level (1000 mg/kg p.o. / day) showed a mixed trend of both increase and decrease in haematological, enzymological and biochemical parameters. But all these changes were observed to be within the normal range and were further supported by histopathological evaluation of the organs. The results of the study reveals that the extracts and fractions of K. rotunda is not acutely toxic up to 2000 mg/kg of body weight/day p.o and the no-observed-adverse-effect level (NOAEL) of the extract and fractions for both male and female rats is considered to be greater than 1000 mg/kg of body weight/day, p.o. for 28 days.