Experimental study of acute toxicity of the intramuscular form of a specific immunobiostimulator — transfer factor

Relevance . The article presents data on the toxicological assessment of the safety of the specific immunobiostimulant of antigen-directed action “Transfer Factor” in a form ready for intramuscular administration and obtained from the blood of hyperimmunized donors on laboratory animals in an acute experiment. Methods . The object of the study was the finished form of “Transfer Factor”, the acute toxicity of which was determined in models on laboratory animals (nonlinear mice, nonlinear rats). Results . It was found that after administration of the drug to mice intramuscularly (0.25 ml/head) and intraperitoneally (0.5 ml/head), to rats intramuscularly (2.5 ml/head) and intraperitoneally (2.5 ml/head), muscle tremor is observed, disappearing after 15–20 minutes. Intraperitoneal administration of the drug to mice and rats in dosages of 0.75 ml/head and 3.75 ml/head, respectively, determines the presence of tremor lasting 40 minutes. During the 14-day observation period, the body weight of mice and rats increases by 10.15-14.25 and 11.84-17.67%. Autopsy of animals does not reveal visible changes in the location of organs and fluid in the abdominal and pleural cavities. However, some pathological changes in color, consistency and size are found in the lungs, heart, spleen and liver with intramuscular administration of Transfer Factor to mice and rats at a dose of 0.25 ml/head and 2.5 ml/head, intraperitoneal administration to mice at a dose of 0.5 ml/head and 0.75 ml/head and to rats 2.5 ml/head and 3.75 ml/head. Based on the totality of changes in the vital signs of laboratory animals, body weight and macroscopic characteristics of internal organs according to GOST 12.1.007-76, the drug “Transfer Factor” can be classified as hazard class IV “Low-hazard substances”.