A dose range study to assess the teratogenic potential of aqueous extract of Labisia pumila
(Kacip Fatimah) was conducted in rodents. The extract at doses of 0 (control), 2, 20, 200, 400, 1000 mg/kg/day were respectively administered by gavaging to 6 groups of pregnant Sprague Dawley rats from day 6 through day 16 of pregnancy and sacrificed on day 21. No significant agent-related effects including changes in maternal body weight (MBW) nor weight gain were observed. The corrected maternal body weights (CMBW) were slightly higher in animals receiving low dose extracts (2 mg/kg/day) as compared to all groups of animals. However, body weight differences were not statistically significant. Gravid uterine weight, number of corpora lutea, number of implantation sites, percentage of foetal resorptions, number of life foetuses, foetal weight and foetal sex ratio showed no significant differences among all group animals. None of the foetuses from all dams showed evidence of external congenital malformations. These findings may suggest that aqueous extracts of Labisia pumila var. alata
up to 1000 mg/kg/day statistically do not show any significant teratogenic effects in rats but do affect the maternal body weight and this is dose dependent.