Abstract

EVALUATION OF SKIN IRRITATION POTENTIAL OF PRAPUNNATBIJADI LEPA: A PRECLINICAL SAFETY ASSESSMENT IN WISTAR RATS

*Dr. Neelam Valhekar, Dr. Nagnath Gangasagre

Abstract

Background: Prapunnatbijadi Lepa is a classical Ayurvedic formulation traditionally used in managing inflammatory and dermatological conditions. Before clinical application, scientific validation of its dermal safety is imperative to ensure non-toxicity and therapeutic reliability. Objective: This study aimed to evaluate the dermal irritation potential of Prapunnatbijadi Lepa in Wistar rats using a well-established preclinical in vivo model. Materials and Methods: Twelve healthy female Wistar rats were randomly allocated into two groups: Group I (Control) and Group II (Test, Prapunnatbijadi Lepa). The test formulation was applied topically for seven consecutive days after hair removal from the dorsal region. Dermal responses including erythema, oedema, and irritation index were monitored and scored as per OECD 404 guidelines. Additional parameters included body weight changes, food consumption, clinical signs, necropsy findings, and organ weight analysis. Results: No dermal irritation, oedema, or systemic toxicity was observed in the test group throughout the study period. The irritation index remained zero in all animals. Statistically insignificant differences in body weight gain, food consumption, and organ weights were noted between the control and test groups. Gross necropsy and histopathological assessments showed no abnormalities. Conclusion: Prapunnatbijadi Lepa is devoid of dermal irritation potential and is safe for topical use in rats. The findings reinforce the safety of traditional formulations when evaluated using modern toxicological protocols.

Keywords: Prapunnatbijadi Lepa, dermal safety, OECD 404, skin irritation, Ayurveda, Wistar rats, toxicological evaluation.