PRENATAL DEVELOPMENTAL TOXICITY EVALUATION OF LOW MOLECULAR WEIGHT GALACTOMANNANS BASED STANDARDIZED FENUGREEK SEED EXTRACT DURING ORGANOGENESIS PERIOD OF PREGNANCY IN RATS

Objective: To evaluate the prenatal developmental toxicity of low molecular weight galactomannans based standardized fenugreek seed extract (LMWGAL-TF).Methods: Rats received oral administration of LMWGAL-TF (250, 500 and 1000 mg/kg) during the period of gestation from day 5 (implantation day)–19 (1 d before expected day of parturition) post conception. Maternal, embryo, and fetal toxicity parameters were evaluated.Results: LMWGAL-TF exposure did not produce maternal (clinical observations, body weight gain, food intake) and embryo–fetal toxicity. Occasional skeletal and visceral malformations, unrelated to the treatments, were seen in both LMWGAL-TF-treated and vehicle control (VC) groups.Conclusion: Oral exposure of LMWGAL-TF during the prenatal period did not induce significant maternal and embryo–fetal toxicity up to a dose of 1000 mg/kg in rats. The dose of 1000 mg/kg was considered as NOAEL for LMWGAL-TF.Keywords: Developmental toxicity, Low molecular weight galactomannans, Standardized fenugreek seed extract, OECD Test No. 414, Reproductive system, Rat