SUB-ACUTE ORAL TOXICITY EVALUATION OF GYNOVEDA® BEEHJ AYURVEDIC TABLETS IN WISTAR RATS AS PER OECD TG 407

Abstract

Background: Gynoveda® BEEHJ Ayurvedic Tablets are an Ayurvedic formulation intended for use in the management of male infertility. As formulations used in fertility management may require repeated and prolonged administration, systematic evaluation of their safety following repeated exposure is important. Repeated-dose toxicological assessment provides information regarding potential cumulative effects and target-organ toxicity.[1] Objective: To assess the systemic and target-organ toxicity of Gynoveda® BEEHJ Ayurvedic Tablets following repeated oral administration at therapeutic-equivalent, intermediate, and high dose levels in male and female Wistar rats. Methods: Forty healthy Wistar rats, comprising 20 males and 20 females, were randomly allocated into four groups: normal control, low-dose (225 mg/kg/day), medium-dose (450 mg/kg/day), and high-dose (1125 mg/kg/day) groups. The doses were derived from the marketed human dose using body-surface-area-based allometric scaling.[2] The formulation was administered orally by gavage for 28 consecutive days. Animals were monitored for mortality, clinical and behavioural abnormalities, body weight, and food and water consumption. At the end of the treatment period, haematological and serum biochemical investigations were performed, followed by necropsy and histopathological examination of major organs, consistent with the endpoints recommended for repeated-dose oral toxicity assessment.[1] Results: No mortality or treatment-related clinical signs of toxicity were observed in any treatment group during the 28-day study period. Animals demonstrated normal body-weight progression and maintained normal food and water consumption. No treatment-related abnormalities were observed in clinical or behavioural parameters. Haematological and serum biochemical parameters showed no treatment-related toxicological pattern. Histopathological examination of major organs revealed no treatment-related lesions. A mild elevation of serum phosphorus was noted in the high-dose satellite animals; no other significant biochemical abnormality was reported. The study established a No Observed Adverse Effect Level (NOAEL) of 1125 mg/kg/day for both male and female rats. Conclusion: Repeated oral administration of Gynoveda® BEEHJ Ayurvedic Tablets for 28 days did not produce evidence of systemic or target-organ toxicity in Wistar rats at doses up to 1125 mg/kg/day. The findings support a favourable sub-acute safety profile of the formulation under the experimental conditions of the present study.