PRECLINICAL EVALUATION OF REPRODUCTIVE AND DEVELOPMENTAL SAFETY OF METHANOL SUB-FRACTION OF CARICA PAPAYA SEEDS IN ALBINO RATS
Prajakta Mahajan, Utkarsh Mandage*, Anoopa Purushu, Amrapali Pagare, Pratik Jadhav, Poonam Chaure and Dr. Pankaj Chaudhari
ABSTRACT
The present study was conducted to evaluate the reproductive and developmental safety of the methanol sub-fraction (MSF) of the benzene chromatographic fraction obtained from the chloroform extract of Carica papaya seeds in Wistar rats. MSF was administered orally at graded doses of 50 mg/kg (contraceptive dose), 100 mg/kg (2× CD), 250 mg/kg (5× CD), and 500 mg/kg (10× CD) body weight/day, along with a vehicle-treated control group. Each group comprised 10 male and 20 female rats. Necropsy was performed one day prior to expected parturition to assess pregnancy outcomes. Parameters such as the number of gravid and non-gravid uteri, corpora lutea in ovaries, implantation sites, fetal resorption, fetal body weight, and presence of external, visceral, or skeletal anomalies were recorded. Pregnancies were observed in the control and 50 mg/kg dose group, whereas animals treated with higher doses (100, 250, and 500 mg/kg) did not become pregnant. However, no fetal abnormalities or signs of developmental toxicity were observed in the pregnant animals treated with 50 mg/kg MSF. Fetal body weight, morphological features, and skeletal development were comparable to the control group, indicating no teratogenic effects. These findings suggest that the MSF of Carica papaya seeds does not exert embryotoxic or teratogenic effects and appears to be safe at the contraceptive dose level.
Keywords: Carica papaya seeds, Methanol sub-fraction, Reproductive toxicity, Implantation, Teratology, Albino rats.
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