Affiliation:
1. All-Russian Scientific Research Institute for Fundamental and Applied Parasitology of Animals and Plant – a branch of the Federal State Budget Scientific Institution “Federal Scientific Centre VIEV” (VNIIP – FSC VIEV)
Abstract
The purpose of the research is to evaluate some toxicological parameters of antiparasitic selamectin-based drug.Materials and methods. The study drug is a solution for external use, 1 mL of which contains the active component selamectin (120 mg), as well as additives. The experiments used a total of 66 white outbred male rats, 42 white outbred male mice and 3 guinea pigs. The parameters of acute oral toxicity (in mice and rats), acute dermal toxicity (in rats), and dermal and mucous membrane irritation (in rats and guinea pigs) of antiparasitic selamectin-based drug were evaluated. LD50 was calculated and the irritation of the drug was evaluated using established procedures in toxicology.Results and discussion. The maximum tolerated dose of the selamectin-based drug was 2550 mg/kg in the mice and 4250 mg/kg in the rats. The absolutely lethal dose for the mice and the rats was 6800 and 8500 mg/kg, respectively. It was established that the drug belonged to hazard class 3 (moderately hazardous substances) when administered intragastrically to the animals: LD50 for the mice was 4816.7 mg/kg, and LD50 for the rats was 6091.7 mg/kg. In determining acute dermal toxicity in the rats, the drug was classified as hazard class 4 (low-hazardous substances): LD50 more than 8500 mg/kg. The drug irritant effect on the skin of the rats at doses of 4250, 6375 and 8500 mg/kg was not established. The drug had a mild effect on the mucous membrane of the eyes of the guinea pigs with its recovery to normal within 24 hours.
Publisher
Institute of Fundamental and Applied Parasitology of Animals and Plants
Reference19 articles.
1. Biryukova N. P., Rusakov S. V., Napalkova V.V., General principles of preclinical safety evaluation of pharmacological drugs for veterinary use. Veterinarnyy vrach = Veterinary Doctor. 2018; 1: 3-9. (In Russ.)
2. Vasiliev A. N., Niyazov R. R., Gavrishina E. V., Dranitsyna M. A., Kulichev D. A. Problems of planning and performing preclinical studies in the Russian Federation. REMEDIUM = REMEDIUM. 2017; 9: 6-18. https://doi.org/10.21518/1561-5936-2017-9-6-18
3. Vasiliev A. N. High-quality preclinical research is a necessary stage in new drug development and introduction into clinical practice. Antibiotiki i khimioterapiya = Antibiotics and chemotherapy. 2012; 57 (1-2): 41-49. (In Russ.)
4. Guskova T. A. Preclinical toxicological study of drugs as a guarantee of clinical trial safety. Toksikologicheskiy vestnik = Toxicological Bulletin. 2010; 5 (104): 2-5. (In Russ.)
5. Djafarov M. Kh., Vasilevich F. I., Menchikov L. G., Chernoburova E. I., Zavarzin I. V. Chemistry of avermectins and milbemycins: monograph. M.: MAX Press, 2022; 200. https://doi.org/10.29003/m2530.978-5-317-06727-4