Safety Assessment of Herbal Formulations, Rumbion™ and Tyrel™ in Albino Wistar Rats

Problem statement: Herbal remedies form one of the effective strategies for management of livestock healthcare. Despite the availability of extensive pharmacological information, the toxicological data on herbs and herbal preparations seem to be scanty. The objective of the present investigation was to evaluate the acute oral toxicity of some herbal veterinary preparations in albino Wistar rats. Approach: In the sighting study, the investigational substances (Rumbion™ and Tyrel™) were orally administered in sequential manner to one animal each at 2000 and 5000 mg kg^-1 body weight followed by four animals at 5000 mg kg^-1 body weight in the main study. The treated animals were observed for mortality, adverse clinical signs, changes in body weight gain and necropsy findings during the study. Results: The results of the present study revealed that the treated rats survived throughout the study period and did not exhibit any treatment related abnormal clinical signs at the tested dose levels. Overall, the percent body weight gain in rats treated with the herbal preparations was found to be normal during the 14 day observation period. Postmortem examination of rats did not reveal any major abnormalities. Conclusion: In summary, acute oral toxicity testing of herbal veterinary formulations did not cause any treatment-related adverse effects up to the dose level of 5000 mg kg^-1 body weight and hence the tested products were labeled unclassified in the hazard category according to Globally Harmonised System.