Open AccessPRENATAL DEVELOPMENTAL TOXICITY EVALUATION OF FUROSTANOL SAPONIN GLYCOSIDE BASED STANDARDIZED FENUGREEK SEED EXTRACT DURING ORGANOGENESIS PERIOD OF PREGNANCY IN RATS
Author(s) -
Pallavi Deshpande,
Vishwaraman Mohan,
Mukul P Pore,
Shailesh Gumaste,
Prasad Thakurdesai
Publication year - 2016
Publication title -
international journal of pharmacy and pharmaceutical sciences/international journal of pharmacy and pharmaceutical sciences
Language(s) - English
Resource type - Journals
eISSN - 2656-0097
pISSN - 0975-1491
DOI - 10.22159/ijpps.2016v8i12.14942
Subject(s) - fetus , litter , gestation , pregnancy , medicine , endocrinology , biology , zoology , genetics , agronomy
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 non-pregnant 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.