Some features of toxicological properties of a specific immunobiostimulator “Transfer factor” in preclinical trials

Abstract. The purpose of the study is to evaluate some aspects of toxicological safety of a specific immunobiostimulant “Transfer factor” in laboratory animal models. Methods. The experiments were performed on mice, rats and guinea pigs. The toxicological safety assessment of the “Transfer factor” preparation included the determination of the following characteristics: chronic toxicity, assessment of specific activity, assessment of embryotoxic and teratogenic properties, assessment of allergenic properties Results. It was established that the introduction of the “Transfer factor” preparation in a chronic toxicological experiment is accompanied by the development of muscle tremor in the rodents’ body, the duration of which depends on the administered dose, route of administration and exposure time, but their body weight increases by 6.29–10.63 %. Autopsy of experimental group animals revealed no visible changes in the arrangement of internal organs and fluid accumulation in the abdominal and pleural cavities, although some pathological changes in color, consistency and size of the lungs, spleen, liver and heart were noted. The mass coefficients of these organs change with an increase in the dose of the administered drug “Transfer factor”, especially with the intraperitoneal route of administration up to 10.39 %. The tested drug in the reaction of lymphocyte blast transformation increases the number of blasts from 0.20 to 1.40 %. The totality of data allows us to state that the drug “Transfer factor” in accordance with GOST 12.1.007-76 belongs to the IV hazard class “low-hazard substances” and it can be recommended for further clinical trials, in which a dosage exceeding 6 ml/kg of live weight will not be used, when administered to laboratory animals, a complex of changes in the internal organs develops. Scientific novelty. The introduction of “Transfer factor” does not affect the condition and functions of the reproductive organs (uterus, ovaries) of pregnant rats, and the drug does not exhibit a negative embryotoxic and teratogenic effect in their body. When studying the allergenic properties of the drug, it was found that it does not cause a general anaphylaxis reaction in the body of guinea pigs, does not irritate the skin in the reaction of immune complexes and the conjunctiva of the eye in the conjunctival test.