Study of the parameters of acute toxicity of the drug “Devimectin 1 %” with a single subcutaneous injection in white rats
In the study of the drug for injectable use – “Devimectin 1 %”, together with the confirmation of therapeutic properties, it is necessary to determine the LD50 obtained in the study of acute toxicity. The aim of the work was to study the acute toxicity of “Devimectin 1 %” in white rats by injection. To fulfill this goal on the principle of analogues was formed control and three experimental groups of 4 animals each (n = 4). The drug was administered in doses of 5000.0; 10000.0; 20000.0 mg/kg body weight in absolute weight of the drug once subcutaneously in the withers. The control animals were injected subcutaneously with sterile saline 1.0 cm3. After taking into account the results of the previous experiment in the main experiment, 7 experimental groups were formed, whose rats were injected subcutaneously with “Devimectin 1 %” in doses of 5000.0; 7500.0; 10000.0; 12500.0; 15000.0; 17500.0 and 20000.0 mg/kg body weight, as well as a control group to which animals were injected with sterile saline with a volume of 1.0 cm3. There were 6 animals in each group (n = 6). It was found that for the administration of the drug at a dose of 5000 mg / kg body weight, no animal died, for 10000.0 and 20000.0 mg/kg body weight, respectively, one and 4 animals died. Death occurred for 2–6 days depending on the administered dose. In the main experiment with subcutaneous administration of “Devimectin 1 %” at a dose of 5000.0 mg/kg body weight during the 14-day period of the study, no animal died; for the introduction of the drug at a dose of 7500.0 mg/kg killed one animal; for 10000.0 – 2; for 12500.0 and 15000.0 – 3 rats; for 17500.0 – 5 rats and for the introduction of the drug at a dose of 20000.0 mg/kg body weight, all experimental animals died. The death of laboratory animals occurred for 2–6 days depending on the administered dose. According to the results of studies, it was found that the LD50 of the drug “Devimectin 1 %” under the conditions of its single subcutaneous administration to female rats is 12881.20 ± 1390.54 mg/kg, LD10 – 5978.43 mg/kg, LD16 – 7495.68 mg/kg, LD84 – 18266.73 mg/kg, LD90 – 19783.98 mg/kg, LD100 – 20959.49 mg/kg body weight, respectively. Therefore, the drug “Devimectin 1%” when administered subcutaneously can be classified as toxicity class VI – substances relatively harmless (LD50subcut> 4500,0 mg/kg). Further studies will be the next step in pre-registration trials to examine the subacute toxicity of “Devimectin 1 %”.
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