Prenatal Developmental Oral Toxicity Evaluation of Defatted Fenugreek Seed Flakes (Fenuflakes^TM) in Laboratory Rats

Prasad Arvind Thakurdesai¹, Pallavi Onkar Deshpande^1*, Rohini Revansiddappa Pujari², Shailesh Anil Gumaste³ and Mukul Prabhakar Pore³

¹Department of Scientific Affairs, Indus Biotech Limited, Rahul Residency, Off Salunke Vihar Road, Kondhwa, Pune, India.

²Department of Pharmacology, School of Pharmacy, Dr. Vishwanath Karad MIT World Peace University, Kothrud, Pune, India

³INTOX Private Limited., Pune, Maharashtra, India.

Corresponding Author E-mail: pallavi@indusbiotech.com

Fenugreek seed-based ingredients showed potential health benefits towards female-specific conditions. The present work is aimed to assess the prenatal oral toxicity of fibers and protein rich defatted fenugreek seed flakes (Fenuflakes™). The acute oral toxicity and dose range-finding studies in non-pregnant and pregnant rats were conducted before the main study. The selected doses of Fenuflakes (500, 1000, and 2000 mg/kg) were orally gavaged to rats daily from day 0 to day 19 (one day before the expected day of parturition) post-conception with the concurrent vehicle control (VC) group. On the 20th day of gestation, the maternal and embryo-fetal toxicity parameters were recorded after the cesarean sections of dams. Results: Fenuflakes in tested doses exposure did not show significant toxicological changes in maternal (body weights, food intake, anogenital distance, or clinical observations) and embryo-fetal evaluations (number of corpora lutea, resorptions, and implantations, or fetus weights, sex ratio or incidence of anomalies) compared with VC. Conclusion: Oral prenatal exposure to Fenuflakes was found safe with no significant maternal and embryo-fetal toxicities. The "No Observed Adverse Effect Level” (NOAEL) of Fenuflakes (> 2000 mg/kg/day) can be used for risk assessment before human consumption in pregnant female population.

Defatted fenugreek seed flakes; OECD No. 414; Prenatal Developmental toxicity; Reproductive system

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