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Cladanthus scariosus (Ball) Oberpr. & Vogt is an endemic species to Morocco (Hight Atlas). It is generally used to treat all disorders where spasm is important; it has tonic, stomachic, analgesic, and antispasmodic properties. It is also renowned for its use in the treatment of diabetes mellitus. The objective of this study is to investigate the acute and subacute toxicity of methanolic extract of C. scariosus (CSME) in mice to evaluate its safety profile. During the acute toxicity study, three groups of female mice were selected: the first control group received distilled water, while the second and third received a single oral dose of 2000 and 5000 mg/kg CSME extract respectively. Abnormal behaviors, toxic symptoms, weight, and death were observed for 14 consecutive days to assess the acute toxicity. For the subacute toxicity study, the extract was administered orally at doses of 250, 500, and 1000 mg/kg and the distilled water was given to the control group daily to Swiss albino female mice for 28 days (n = 6/group) respectively. The general behaviors and body weight of the mice were observed daily. Biochemical, macroscopically, and histopathological examinations of the liver, kidney, spleen, and heart were conducted at the end of the treatment period. Regarding the acute toxicity test, no mortality or adverse effects were noted at the dose of 5000 mg/kg. In the subacute study, the CSME extract induced no mortality or treatment-related adverse effects concerning body weight, general behaviors, relative organ weights, and biochemical parameters. Histopathological examination of vital organs showed normal architecture suggesting no morphological alterations compared to the control group. The present study revealed that oral administration of CSME extract for 28 days at a dose of up to 1000 mg/kg did not induce toxicological damage in mice. Based on the acute toxicity study, the median lethal dose (LD50) of the extract was estimated to be over 5000 mg/kg.
