Bìol. Tvarin, 2017, Volume 19, Issue 1, pp. 8387

COMPARATIVE ANALYSIS OF RESEARCH OF ACUTE TOXICITY OF ANTHELMINTIC PHYTOPREPARATION “SHCHYTNYK” BY CLASSICAL AND ALTERNATIVE METHODS

J. Perig

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State Scientific-Research Control Institute of Veterinary Medicinal Products and Feed Additives,
11 Donetska str., Lviv 79019, Ukraine

According to international requirements the testing of safety (toxicity) of various substances in living systems (human, animals and ecosystems) is carried out according to the harmonized methodological recommendations of the organization for Economic Cooperation and Development (OECD) and the International Conference on Harmonization of Technical Requirements for Registration of medicines (ICH). At the moment the scientific community and regulatory authorities of EU countries are paying great attention to the establishment of security and range of toxic effects of drugs, chemicals, biotechnology products and various nanomaterials.

The article contains the results due to the comparative determination of parameters of acute toxicity of phytopreparation “Dryopteris filix-mas” using classical and alternative (European) methods.

The principle of alternative (European) method for determining acute toxicity is based on a phased procedure using the minimum number of animals at each stage of the research, which suggests the classification of investigated substance of attributing it to one of the categories of toxicity classes, which are defined DL50 fixed threshold values. An alternative method for determining the acute toxicity class according to the OECD (test no. 423) does not apply mandatory a fatal outcome and for the experiment using the minimum number of animals.

According to the classical method of determining acute toxicity was carried out in two stages: previous and extended. At the preliminary stage of research the drug was administered in doses of 500 to 4500 mg/kg, at intervals of 1000 mg/kg and each dose was used on 3 laboratory animals. In the expanded stage research groups of 6 animals in each are formed. The drug was injected in doses ranging from 5.000 to 13.000 mg/kg, at intervals of 2000 mg/kg of animals body weight. Class of toxicity was determined by JMA 85.2-37-736:2011.

It was established that DL50 preparation “Dryopteris filix-mas” according to the classic method determining the parameters of acute toxicity is more than 13.000 mg/kg and the alternative more than 5000 mg/kg. At a classic research it has been spent 39 laboratory animals, but at the alternative — 9animals.

Keywords: OECD TEST No 423, THE CLASSIC METHOD, ALTERNATIVE METHODS, ACUTE ORAL TOXICITY, FIXED DOSE, DRYOPTERIS FILIX-MAS, WHITE RATS

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