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Prenatal developmental toxicity evaluation of IDM01, a botanical composition of 4‑hydroxyisoleucine and trigonelline based standardized fenugreek seed extract, during organogenesis period of pregnancy in rats

Pallavi Deshpande, Vishwaraman Mohan, K R Raghunatha Reddy, V R L N Manjunath, Prasad Thakurdesai.

Abstract
The present study was undertaken to assess the developmental toxicity of botanical composition of standardized fenugreek seed extract with makers 4‑hydroxyisoleucine and trigonelline (IDM01) during organogenesis period of pregnancy in rats in accordance with OECD guideline (No. 414). Pregnant rats were administered by gavage at 125, 250, and 500 mg/kg per day of IDM01 over the exposure period of gestational days 5–19 (GD5-GD19). The vehicle control (VC) group was also maintained. The cesarean sections of dams on GD20 were done. All fetuses were examined for external, visceral, and skeletal alterations. IDM01 treatment did not adversely affect maternal parameters (body weights, uterine weight, uterine observations, feed consumption, and gross pathology), or fetal developmental parameters (fetal body weight, crown-rump length, sex ratio and incidence of anomalies) as compared to VC group. In conclusion, the prenatal oral exposure of IDM01 during organogenesis period to pregnant female rats is without any of maternal or developmental (fetotoxicity or teratogenicity) with "No Observed Adverse Effect Level” (NOAEL) greater than 500 mg/kg/day.

Key words: Developmental toxicity; Fenugreek seeds extract; 4-hydroxyisoleucine; trigonelline; OECD Test No. 414



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