Context: Withania somnifera (L) Dunal (Solanaceae) is an important traditional herbal medicine used for thousands of years and is considered as the Indian ginseng. Reports on the effect of Withania somnifera root (WSR) extract on the developing foetus of pregnant rats including mortality, structural abnormalities, changes in growth and effects on dams are not available.
Objective: The present study was performed to evaluate the prenatal developmental toxicity potential of WSR extract in rats.
Materials and methods: WSR extract was given orally to pregnant rats during the period of major organogenesis and histogenesis (days 5 to 19 of gestation) at the dose levels of 500, 1000 and 2000 mg/kg/day. Clinical observations including mortality, moribundity, behavioural changes, signs of overt toxicity, body weight, gross pathological changes of dams and foetal analyses including external malformations, skeletal and soft tissue malformations were evaluated.
Results: No evidence of maternal or foetal toxicity was observed. WSR extract caused no changes (p < 0.05) in body weight of parental females, number of corpora lutea, implantations, viable foetuses, external, skeletal and visceral malformations.
Discussion and conclusion: Under the conditions of the study, the no-observed-effect level (NOEL) of WSR extract for maternal and developmental toxicity was concluded to be at least 2000 mg/kg/day.
Keywords: Alternative medicine; Indian ginseng; Siddha; ayurveda; herbal; safety; teratology.