Safety evaluation of enriched fraction from leaves of Dillenia indica L. in BALB/c mice

The enriched fraction derived from Dillenia indica L. (Dilleniaceae), also known as elephant apple was subjected to acute and sub-acute toxicological study to document its safety issues for use as fumigant. The enriched fractions were orally administered to both sexes of BALB/c mice at doses of 200, 800 and 1600 mg/kg bw for acute toxicity, and 50 and 500 mg/kg bw for 14 days of sub-acute toxicity. Experimental results revealed that there were no signs of adverse toxicity, and mortality, with no significant treatment related effect in the percentage weight gain, daily feed and water intake, and haematological parameters. However, at higher dose in sub-acute toxicity study a patch of mild tubular injuries in kidney of female mice were observed as suggested by histopathological studies and mild abnormalities in levels of serum biochemical parameters. In general, it can be considered that the enriched fraction from D. indica leaves on oral feeding does not show any adverse effect on mice of both sexes. Hence, the highest doses 1600 mg/kg bw (acute) and 500 mg/kg bw (sub-acute) can be used as basal dose for the determination of no-observed-adverse-effect level (NOAEL) of enriched fraction from D. indica to calculate its safety margin.