Prenatal Developmental Oral Toxicity Evaluation of Defatted Fenugreek Seed Flakes (FenuflakesTM) in Laboratory Rats

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.