Toxicological evaluation of herbo-mineral formulation: Acute and sub-acute oral toxicity in rats

Abstract

Background

Toxicity evaluation is an essential component of the preclinical safety assessment for herbal and herbo-mineral formulations intended for repeated use.

Objectives

The present study was undertaken to assess the acute and subacute oral toxicity of an Ayurveda-based herbo-mineral formulation (HMF) comprising Tinospora cordifolia (Thunb.) Miers, Withania somnifera (L.) Dunal, and Kukkutandatvak bhasma in rats.

Methods

An acute toxicity of a prepared HMF was conducted at a single oral dose of 2000 mg/kg in rats as per OECD guideline 423. Sub-acute toxicity of HMF was evaluated at 250, 500, and 1000 mg/kg by oral administration in rats in accordance with OECD Test Guideline 407.

Results

No mortality and clinical signs of toxicity were produced in rats by a single oral administration of a 2000 mg/kg dose of HMF. In the subacute toxicity study, body weight gain and food consumption patterns in the HMF-treated groups were comparable to those of the vehicle control group. Hematological and serum biochemical parameters remained within physiological limits. The relative organ weights did not differ significantly between the control and HMF-treated groups. Histopathological evaluation of the organs of HMF-treated rats revealed normal findings. No delayed or residual toxicity was observed in the satellite group.

Conclusion

HMF was found to be safe following a single 2000 mg/kg dose and at a 28-days repeated dose of 1000 mg/kg by the oral route in rats. The study findings support the safety of the HMF and provide a scientific basis for further preclinical and clinical development.