Safety Evaluation of the Polyherbal Formulation NawaTab: Acute and Subacute Oral Toxicity Studies in Rats.

Abstract

NawaTab is a tablet formulation developed from the Nawametho polyherbal formula used in Surat Thani province, Southern Thailand, for the treatment of hyperlipidemia. This study aims at evaluating the acute and subacute toxicity of NawaTab in rats. In the acute toxicity study, NawaTab was evaluated in female rats following the OECD Guideline No. 423. In the subacute toxicity study, NawaTab was tested in both male and female rats following the OECD Guideline No. 407. In the acute toxicity study, no lethal effects or toxic signs were observed during the duration of the study. In the subacute toxicity study, there was no mortality and no abnormality in clinical signs, body weight, food consumption, relative organ weight, and hematological parameters of NawaTab-treated rats. Significantly increased water consumption by male rats (500 mg/kg BW) and female rats (250, 500, and 1000 mg/kg BW) was observed. In addition, globulin and total cholesterol of female rats (1000 mg/kg BW) significantly increased. These alterations were within normal physiological ranges. Moreover, necropsy and histopathological findings of NawaTab-treated rats demonstrated no obvious alterations attributable to NawaTab administration. The present study revealed that NawaTab has no significant acute oral toxicological effects. The lethal dose with a 50% mortality rate (LD50) was higher than 5000 mg/kg BW in rats. The subacute oral administration of NawaTab for 28 days did not have any major toxicological effects. Based on this study, NawaTab could be safe to use with caution pending its chronic toxicity study.