Abstract

The important aspect of the high quality new pharmaceuticals is safety assessment in animals in practical conditions. Toxicity assessment of the new antiparasitic multicomponent drug (Inspector Quadro Tabs) composed of lufenuron, praziquantel and moxidectin in the form of tablets for cats and dogs was carried out. The parameters of acute oral toxicity were determined on white mice and white rats and subchronic toxicity was observed after repeated oral administration to rats. Embryotoxicity and teratogenicity of the drug were also evaluated. As a result of toxicological studies, median lethal doses (LD50) of the drug during oral administration to the 60 white mice were established which were equal to the following: LD50 = 14800 mg/kg (Karber's method), 13800 mg/kg (Miller and Tatener’s method); to the white rats LD50 ˃ 16912 mg/kg; according to the generally accepted classification, the drug belongs to the fourth class of hazard (low hazard substances). It was established that doses of 1691 mg/kg, 846 mg/kg and 338 mg/kg were threshold in a subchronic experiment on the rats. Moreover, it was found that the drug did not possess embryotoxic and teratogenic properties in pregnant female rats. Experimental results have confirmed the low toxicity of a new antiparasitic multicomponent drug.