<p>The article is devoted to a preclinical study of the chronic toxicity of a wound-healing gel. Acute toxicity was determined in outbred male white mice (20 ± 2.5 g) and rats (180 ± 20 g) using single subcutaneous and oral administrations. In the first series, the experimental gel was administered perorally; in the second, subcutaneously in doses of 0.1, 0.13, 0.16, and 0.2 ml per mouse. The gel was administered perorally and subcutaneously to rats in doses of 1.0, 1.3, 1.6, and 2.0 ml per animal or 5,000 – 10,000 mg/kg. The acute toxicity study of the gel showed that it belonged to class VI non-toxic compounds. The LD₅₀ was &gt;10,000 mg/kg after peroral and subcutaneous administration to mice and rats. The gel did not affect the behavior and weight of rats and rabbits with daily multiple external use. The gel did not have a toxic effect on the function of the kidneys and liver and the morphology of organs and tissues of the animals and did not significantly affect the blood coagulation system. After 30 days of the experiment under the influence of the gel, the clot formation time (K) increased by 72% (<i>p</i> = 0.002), indicating a decrease in the formation rate of thrombin and fibrinogen. At the same time, the thrombin utilization constant R/K, which expresses the ratio of the thromboplastin generation rate to the amount of thrombin formed, decreased by 33% (<i>p</i> = 0.001). These changes led to a decrease in the clot elasticity coefficient by 37% (<i>p</i> = 0.046) and the hypercoagulation index Ci by 37.1% (<i>p</i> = 0.003) and an increase in the total duration of blood clotting (R + K) by 34% (<i>p</i> = 0.050) relative to the initial data. All the above data indicated that the developed gel did not have a toxic effect on the animal body.</p>