Objective: This study aims to investigate the sub-acute oral toxicity of a methanolic leaf extract of Clinacanthus nutans (MECN) in male and female mice.Methods: The study used three groups of male and female mice, the crude MECN was dissolved in distilled water and administered orally in single doses of 1000 and 2000 mg/kg body weight for 28 d by gavage, at a dosing volume of 10 ml/kg body weight, while the control group received only the distilled water. Mice were weighed weekly for the duration of the study period. After the treatment period, the blood samples were collected and examined for hematology changes, total red blood cell (RBC) and total white blood cell (WBC), packed cell volume (PCV) and plasma protein concentration. The serum was analyzed for liver and kidney function test. The degree of injury of the liver and kidney tissue was histopathologically assessed and scored under the light microscopy. one-way analysis of variance (ANOVA) with Turkey’s test was used to analyze the difference (p<0.05) of means across treatment groups.Results: There were no significant (p>0.05) changes in the body weight, hematological, biochemical and histology signs of toxicity for both male and female mice, except for the sodium level which was decreased in the mice treated with 2000 mg/kg of MECN (137±5.06) as compared to the 1000 (151±1.91) mg/kg as well as the control males (152±3.74) [F=4.87, p=0.03].Conclusion: This study showed that MECN at dosages up to 2000 mg/kg is safe to be used in mice regardless of their sex. Overall, this study suggests the potential utility of MECN in the development of herbal drug formulations in vivo.

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