PRENATAL DEVELOPMENTAL TOXICITY EVALUATION OF FUROSTANOL SAPONIN GLYCOSIDE BASED STANDARDIZED FENUGREEK SEED EXTRACT DURING ORGANOGENESIS PERIOD OF PREGNANCY IN RATS


Pallavi Deshpande, Vishwaraman Mohan, Mukul Pore, Shailesh Gumaste, Prasad Thakurdesai

Abstract


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.


Keywords


Developmental toxicity, Fenugreek seeds extract, Furostanol saponin glycosides, OECD Test No. 414

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About this article

Title

PRENATAL DEVELOPMENTAL TOXICITY EVALUATION OF FUROSTANOL SAPONIN GLYCOSIDE BASED STANDARDIZED FENUGREEK SEED EXTRACT DURING ORGANOGENESIS PERIOD OF PREGNANCY IN RATS

Keywords

Developmental toxicity, Fenugreek seeds extract, Furostanol saponin glycosides, OECD Test No. 414

DOI

10.22159/ijpps.2016v8i12.14942

Date

01-12-2016

Additional Links

Manuscript Submission

Journal

International Journal of Pharmacy and Pharmaceutical Sciences
Vol 8, Issue 12, 2016 Page: 124-129

Online ISSN

0975-1491

Statistics

288 Views | 227 Downloads

Authors & Affiliations

Pallavi Deshpande
Indus Biotech Private Limited, Kondhwa, Pune, Maharashtra, 411048, India
India

Vishwaraman Mohan
Indus Biotech Private Limited, India
India

Mukul Pore
INTOX Pvt. Ltd., Pune, Maharashtra, 412115, India
India

Shailesh Gumaste
INTOX Pvt. Ltd., Pune, Maharashtra, 412115, India

Prasad Thakurdesai
Indus Biotech Private Limited, Kondhwa, Pune, Maharashtra, 411048, India
India


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