ABSTRACT Safety evaluation of Origanum majorana volatile oil was investigated. Acute toxicity studies median lethal doses (LD50 values) were carried out in mice and rats. Single doses of the tested drug were given orally and clinical signs, symptoms, and mortality were recorded during a 14-day observation period. Chronic toxicity, reproductive, and mutagenic activity studies were evaluated in rats and mice. Repeated oral dosing of up to 40 mg/kg was ineffective in rats and mice. Oral teratology study on pregnant rats using higher doses revealed no evidence of the teratogenicity potential of the Origanum majorana oil. The tested preparation was also devoid of mutagenic activity in mice at all doses. The results collectively confirmed that the oil under test has a wide safety margin with no evidence of impaired fertility, teratogenicity potential, or mutagenic activity. The results showed that volatile oil derived from Origanum majorana is well tolerated with oral LD 50 of 1.203 g/kg in mice and 1.666 g/kg in rats. A significant decrease in blood glucose, cholesterol, triglycerides, and total lipid levels was observed after two and three months of drug administration.
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