Acute Oral Toxicity Study of Exapar Premix in Wistar Rats: A Polyherbal Formulation for Uterine Cleansing and Restoration in Veterinary Practice
Vaidya M.G.
Department of Veterinary Pharmacology and Toxicology, College of Veterinary and Animal Sciences, Akola, University MAFSU, Nagpur, Maharashtra – 444104, India.
Mistu Tripura
Department of Veterinary Pharmacology and Toxicology, College of Veterinary and Animal Sciences, Akola, University MAFSU, Nagpur, Maharashtra – 444104, India.
Damekar Soundarya
Department of Veterinary Pharmacology and Toxicology, College of Veterinary and Animal Sciences, Akola, University MAFSU, Nagpur, Maharashtra – 444104, India.
Giri S. S.
Department of Veterinary Pharmacology and Toxicology, College of Veterinary and Animal Sciences, Akola, University MAFSU, Nagpur, Maharashtra – 444104, India.
Kamdi B. P.
Department of Veterinary Pathology, College of Veterinary and Animal Sciences, Akola, Maharashtra – 444104, India.
Gupta S.
Zenex Animal Health India Private Limited, Baddi, HP, India.
Hajare S.W. *
Department of Veterinary Pharmacology and Toxicology, College of Veterinary and Animal Sciences, Akola, University MAFSU, Nagpur, Maharashtra – 444104, India.
*Author to whom correspondence should be addressed.
Abstract
Aims: The present study evaluated the acute oral toxicity potential of Exapar Premix in Wistar rats following the OECD-423 and 425 guidelines.
Study Design: Acute oral toxicity study based on a single-dose administration protocol.
Place and Duration of Study: The study was conducted at the Laboratory Animal Facility, Department of Veterinary Pharmacology and Toxicology, Post Graduate Institute of Veterinary and Animal Sciences (PGIVAS), Akola, Maharashtra, India (MAFSU, Nagpur). The experiment was carried out in a controlled laboratory setting over a 14-day observation period, preceded by a five-day acclimatization phase.
Methodology: Experiment was conducted on six adults female Wistar rats (108–123 g). The Exapar Premix was administered orally to separate single rat @ 300 mg/kg and 2000 mg/kg body weight in a sighting study and in main test 4 rats were taken separately received 2000 mg/kg of product orally. The animals were continuously monitored for clinical signs of toxicity, behavioral changes and mortality. Body weight was recorded during the 14-day period. On the last day of experiment, biochemical parameters including aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP) and creatinine levels, were analyzed. The rats were then humanely euthanized using diethyl ether and histopathological examinations of the heart, liver, kidneys and lungs were performed to examine any microscopic abnormalities.
Results: No mortality or adverse clinical signs were observed in any of the treated animals. Body weight remained within the normal physiological range throughout the study. The estimated biochemical analytes AST, ALT, ALP and creatinine were observed within normal reference ranges, indicating no systemic toxicity. Histopathological examination showed no significant microscopic abnormalities in the examined vital organs.
Conclusion: Exapar Premix upon oral administration do not cause acute oral toxicity in Wistar rats, with an LD₅₀ exceeding 2000 mg/kg body weight. These findings confirm its safety for oral administration.
Keywords: Exapar premix, OECD 423, wistar rat, polyherbal formulation