Peganum harmala L. (Harmel) is a widely used plant in the traditional Algerian medicine. The objective of the present study was to assess the safety profile of the P. harmala hydromethanolic seed extract (PhHm). The acute toxicity of PhHm extract was carried out based on OECD guidelines 425, where the extract was administered to mice by gavage in single doses. While in the chronic study, the extract was administered orally for 90 days in rats. The antioxidant (in vitro and in vivo) and antiproliferative activities of PhHm extract were also investigated. In the acute and chronic toxicity, the extract did not cause any behavioral changes and any mortality. In both study a significant increase in liver enzymes was observed while urea and creatinine levels decreased in the treated animals. In the repeated oral administration of PhHm extract, an increase of the platelet numbers was noted and the histological examination of the liver showed a leukocyte infiltration and a vascular congestion. For kidneys, the presence of glomerular and modular congestion was also observed and sinusoidal dilation in chronic toxicity. The PhHm extract was more cytotoxic to HeLa cell line and exhibited potent antioxidant in vitro and in vivo. It can be suggested, based on the results of this study that the PhHm seed extract was moderately toxic in acute administration (LD50 of 501.47 mg/kg) and the use of this extract is safe at doses ≤ 100 mg/kg. P. harmala could be a potential source of bioactive compounds with antioxidant and antiproliferative potential.
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