Prenatal Developmental Toxicity Evaluation of Furostanol Saponin Glycoside Based Standardized Fenugreek Seed Extract during Organogenesis Period of Pregnancy in Rats

Objective: To evaluate prenatal safety of furostanol saponin glycoside based standardized fenugreek seed extract (Fenu-FG) on pregnant female Wistar rats on embryo–fetal development organogenesis period in accordance with OECD guideline (No. 414). Methods: Fenu-FG was administered to pregnant rats by gavage at 250, 500, and 1000 mg/kg/day over the exposure period of gestational days 5– 19. The vehicle control (VC) group was also maintained. All dams were subjected to a cesarean section on gestational day 20 and the fetuses were examined for external, visceral, and skeletal alterations. Results: There was no significant difference found during maternal examination (body weights, food consumption, numbers of pregnant and nonpregnant female rats) or reproductive parameters (gravid uterus weights, litter size and weights, number of fetuses, sex ratio (male/female numbers of implantations and resorption, number of implantation per female, pre-and post-implantation loss (%), dead and live fetuses (%), numbers and weights of corpora lutea) in Fenu-FG-treated as compared to VC group. Furthermore, the few incidental and non-significant malformations were observed in Fenu-FG-treated as well as VC group during external, visceral or skeletal examinations. Conclusion: The prenatal oral exposure of Fenu-FG during organogenesis period to pregnant female rats was devoid of maternal or developmental (fetotoxicity or teratogenicity) with "No Observed Adverse Effect Level” (NOAEL) greater than 1000 mg/kg.