Acute oral toxicity evaluation of Hridayarnava Rasa (A Herbo-Mineral Ayurvedic Formulation) prepared from aśodhita and śodhita tāmra bhasma

Background: Herbo-mineral preparations used in Ayurveda are seen as a matter of concern nowadays; especially for containing metals such as mercury, lead, and copper. One of such formulations is hṛdayārṇava rasa (HR) which contains black sulfide of mercury and tāmra bhasma. Till date, no safety profile of this formulation is available. In the present study, acute oral toxicity of HR prepared from tāmra bhasma in aśodhita and śodhita form was evaluated to provide the safety profile on acute administration. Materials and Methods: HR prepared from śodhita tāmra bhasma (STBHR) and HR prepared from aśodhita tāmra bhasma (ATBHR) was prepared as per the classical reference. Acute toxicity test was evaluated as per OECD 425 guidelines with 2000 mg/kg as a limit test. Fifteen Wistar strain albino female rats (Rattus norvegicus) were randomly divided into three groups of five animals each. One group served as control, and other two served as experimental groups. Test formulation was administered orally to overnight fasted female rats, and detailed behavioral changes and mortality were recorded for 14 days. Parameters such as body weight, hematological and biochemical parameters, and histopathological study of some important organs were assessed. Results: No significant changes in behavior, mortality, body weight, and hematological parameters were observed in all the animals. Some biochemical parameters such as blood urea, alkaline phosphatase, serum glutamic oxaloacetic transaminase, and serum glutamic pyruvic transaminase were affected in both the test drugs. In histopathological study, sections of liver and kidney showed some degenerative changes; comparatively more in ATBHR. Conclusion: The results of the study demonstrate that LD50 of both the test drugs are higher than 2000 mg/kg. It was concluded that both the test drugs at higher dose levels can cause hepatorenal toxicity. However, further chronic toxicity evaluation is necessary to establish the safety profile on chronic administration.