To the procedure of confirmation of the laboratory’s competence in performing mutagenicity assessment using the Ames test

Introduction. The test for the induction of reverse gene mutations (Ames test, OECD* guideline No. 471) is one of the most popular methods for assessing mutagenicity due to its ease of execution and the ability to detect up to 70-80% of substances with carcinogenic activity. The experimental protocol requires a minimum amount of test substance and standard microbiological laboratory equipment. To obtain the primary data, several days from the start of the experiment are required. Despite the existence of publications devoted to the detailed description of the standard Ames test protocol, there is a gap affecting a number of aspects of the procedure for confirming the competence of a testing center using this method in its practice. Materials and methods. When preparing this article, we used the literature data published in domestic and foreign literature over the past 20 years concerning experimental approaches to the implementation of the Ames test. The literature search was carried out in the Scopus, Medline, Google Scholar, RSCI databases. Results. In the FBES “Federal Scientific Center of Hygiene named after F.F. Erisman” of the Federal Service for Surveillance on Consumer Rights Protection and Human Wellbeing the method for assessing the bacterial reverse mutation has found application in assessing the safety of technical products of pesticides, their mixtures and preparative forms, as well as in the examination of equivalence. Testing laboratory center on the basis of the FBES “Federal Scientific Center of Hygiene named after F.F. Erisman” of the Federal Service for Surveillance on Consumer Rights Protection and Human Wellbeing is accredited for compliance with the state standard GOST ISO / IEC 17025-2019 ”General requirements for the competence of testing and calibration laboratories.“ In this article, based on new published data and our own practical experience, a number of necessary conditions are considered for demonstrating the competence of a testing laboratory using the test for the induction of reverse gene mutations in its practice, its ability to obtain reliable results and take actions to manage the risks of laboratory activities. The main attention is paid to ensuring such parameters of the test quality as indicator cultures, metabolic activation system, control of the background of spontaneous mutation, etc. Conclusion. The discussed practical issues can be useful for specialists from research laboratories planning to introduce this method into practice.