Abstract

The aim of the work. Determination of toxicometric characteristics of octenidine hexafluorosilicate (OHFS), characterized by significant pharmaceutical potential, in an acute experiment on rats by oral administration. Materials and Methods. A study of the acute toxicity of octenidine hexafluorosilicate was carry out on 42 male Wistar rats weighing 180–200 grams. The main criterion for quantifying the toxicity of octenidine hexafluorosilicate was LD50, which was determined using the least squares method. In addition, the following hazard indicators were calculated: 1/LD50 – median lethal dose (absolute toxicity), LD84/LD16 – the range of lethal doses (zone of acute toxic effect), 1/(LD50-S) – the total toxicity index and the S-function angle of inclination (variability of lethal doses). Statistical processing of the results was carry out using the «StatPlus 2009» software (AnalystSoft, USA, 2009). Results and Discussion. The results of the acute toxicity determination of octenidine hexafluorosilicate show that this compound, in the oral route of administration, belongs to the III class of toxicity for the human (slightly hazardous) and to the IV class of toxicity for the animals (white rats). Based on the variability of lethal doses, the studied hexafluorosilicate can be attribute to compounds that do not pose a high potential risk of the onset and development of poisoning. The calculated toxicity and hazard values of octenidine hexafluorosilicate show that it does not pose a particular danger to humans. Extrapolation to humans of acute toxicity parameters obtained in animals was determined using the coefficient of resistance to the species and is 132.15 mg/kg body weight. Conclusions. The results of determining the toxicometric characteristics of octenidine hexafluorosilicate in rats by oral administration allow to classify this compound as moderately toxic substances (LD50 = 555.05 mg / kg, toxicity class IV). The determined parameter of acute toxicity of OHFS is close to the LD50 values of other hexafluorosilicates known from the literature; relative safety and high caries-prophylactic and periodontal-protective efficacies of OHFS indicate the prospects for further studies of this compound.

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