Evaluation of acute and sub-chronic toxicity of bitter melon seed extract in Wistar rats

Pharmacological studies have revealed the potential antidiabetic effects of bitter melon seeds (Momordica charantia) in animals and humans. However, the sub-chronic safety of bitter melon seeds remains elusive. This exploratory study aimed to assess the acute and sub-chronic toxicity of a bitter melon seed extract from supercritical carbon dioxide (scCO(2)) extraction in Wistar rats based on the Organization for Economic Co-operation and Development (OECD) guidelines No. 423 and 408. No mortality and toxicity were observed in rats treated with a single dose of the extract during the 14-day observation period. The median lethal dose (LD(50)) of the extract was considered greater than 2000 mg/kg body weight (BW). For the sub-chronic toxicity study, male and female rats were orally administered daily doses of 0, 250, 500, and 1000 mg/kg BW for 90 days. No mortality, morbidity, and abnormal pathological and biochemical alterations were observed. The no-observed-adverse-effect-level (NOAEL) of the bitter melon seed extract was greater than 1000 mg/kg BW. Accordingly, bitter melon seed extract from scCO(2) extraction may be considered a non-toxic dietary ingredient.