Assessment of Prenatal Developmental Toxicity Study of Bitter Melon Seed Extract from Supercritical Carbon Dioxide (scCO2) Extraction in Wistar Rats

Abstract Bitter melon (Momordica charantia) seed extracts exert hypoglycemic effects on animals and humans, but their safety and toxicological effects are still controversial in pregnant women. This study aims to assess the prenatal developmental toxicity of a bitter melon seed extract prepared from supercritical carbon dioxide (scCO2) extraction in Wistar rats based on the Organization for Economic Cooperation and Development (OECD) guideline No. 414. The extract was administered orally from gestation day (GD) 5 to 19, through gavage, to 25 mated female rats per group at the dose levels of 0, 250, 500, and 1000 mg/kg body weight (BW)/day, and all rats were sacrificed on GD 20. There were no mortality, morbidity, and obvious clinical signs of toxicity observed in the control and treatment groups. The results of body weight, weight gain, reproductive parameters (e.g., live/dead foetuses, sex ratio, anogenital distance), fetal examination (i.e., external and visceral observations), organ weight, and thyroid hormone analysis (i.e., tri-iodothyronine (T3), thyroxine (T4), thyroid stimulating hormone (TSH)) in all treatment groups were comparable with those of the control group. The changes in the mean body weight at GD 20, carcass weight in the middle and high groups, and the number of unossified xiphisternum in the high group were considered treatment related but non-adverse. Moreover, gross pathological examination did not find any abnormal lesions in vital organs and thyroid gland. Accordingly, the no observed adverse effect level (NOAEL) of the bitter melon seed extract for maternal and developmental toxicity was determined to be 1000 mg/kg BW.