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

Abstract

<p><strong>Objective</strong>:<strong> </strong>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).</p><p><strong>Methods</strong>:<strong> </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p>

Effects of a Proprietary Blend Rich in Glycoside Based Standardized Fenugreek Seed Extract (Ibpr) on Inflammatory Markers During Acute Eccentric Resistance Exercise in Young Subjects

“…No adverse side effects were reported by any of the participants, nor were any clinical safety markers or hematological variables significantly altered (p>0.05) demonstrating supplement appears safe when taken over 14-day before exercise bout. These results are in line with reported safety profile of the glycoside based standardized fenugreek seed extracts in human subjects [24] as well as animals [25,26].…”

Spice-Derived Bioactive Ingredients: Potential Agents or Food Adjuvant in the Management of Diabetes Mellitus

“…This was similarly reported even after repeated doses for 90 days (Deshpande et al, 2016a ). To further support the galactomannan safety, oral administration during gestation induced no significant maternal and embryo-fetal toxicity up to 1,000 mg/kg bw in rats (Deshpande et al, 2016b ).…”

A systematic literature review of fenugreek seed toxicity by using ToxRTool: evidence from preclinical and clinical studies

“…According to the Klimisch categories of ToxRTool, the category code of these 391 (89.67%) studies were “4” which indicates that a paper is “not assignable” because it does not contain any primary data. Remaining 45 (10.33%) studies were included for quantitative analysis by ToxRTool [6, 7, 8, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59].

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