Assessment of the equivalence of technical materials of analogous pesticides to original active substances on the basis of “mutagenicity” criterion

Abstract

In the Russian Federation about 600 active ingredients of pesticides are currently registered. A large share among them is occupied by analogous pesticides (generics), which may differ in their properties from the original products due to an increased level or altered composition of impurities. Therefore, to ensure the safe use of analogous pesticides, it is necessary to evaluate their chemical and toxicological equivalence. The analysis of algorithms described in international documents and implemented in practice in some countries for determination of the equivalence of technical materials of analog pesticides is presented. Particular attention is paid to the evaluation of pesticide safety on the basis of the mutagenicity criterion. The applicability of different methods for genotoxic activity determination to confirm the equivalence of active substances of pesticides-analogues to patented products is discussed. A brief review of the results of the researches confirming the need to assess the genotoxicity of all technical materials of analogous pesticides with a view to preventing the entry of hazardous substances into the consumer market is presented.