Study of the toxic effect of the drug “Incombivit”
Abstract
Modern veterinary medicine has made great strides in the prevention and treatment of various diseases, largely through the availability of highly effective drugs. One of the major challenges to development of effective, safe, competitive drugs in Ukraine is the creation of an effective system of pre-clinical trials that meet international standards. The toxicity study is a mandatory phase trials of new drugs. The drug “Inkombivit” accommodates only available endogenous biologically active substances, which are natural feed ingredients for animals and are naturally present in animal tissues. All active pharmaceutical ingredients used in drug “Inkombivit”, by the EU regulation No. 37/2010 related to non-hazardous for animals and people compounds. The LD50 of most active pharmaceutical ingredients included in the drug “Incombivit” for mice when administered orally ranges from 5000 to 10000 mg/kg body weight, except for some active pharmaceutical ingredients when they are contained in milligram amounts in 1 liter of the drug, for which LD50 less than 1000 mg/kg body weight of animals. Incombivit is a combination drug that contains fat- and water-soluble vitamins, trace elements and amino acids that normalize metabolism, increase overall resistance, improve productivity, safety and reproductive functions of animals. Acute toxicity of the drug was studied on 50 white mice weighing 19–21 g and on 20 white rats weighing 250–295 g. The animals were kept in accordance with sanitary norms and rules on a standard diet (compound feed) adopted in the vivarium. The acute LD50 of Incombivit for a single oral administration is 7500 ± 229.95 mg/kg body weight for mice and 6250 ± 375.50 mg/kg body weight for rats. Incombivit can be classified as hazard class 4 according to the International Standard GOST 12.1.007-76 and to category 5 according to the International Global Harmonized System (GHS) classification, as its LD50 for mice and rats with a single oral administration exceeds 5000 mg/kg body weight.
Keywords
