Modern approaches to the assessment and classification of the hazard posed by substances with mutagenic effects
Authors:   he Russian Register of Potentially Hazardous Chemical and Biological Substances – the branch of F.F. Erisman Federal Scientific Center of Hygiene of the Rospotrebnadzor, 8 Bagrationovskii passage, bldg 2, Moscow, 121087, Russian Federation, Khamidulina Kh.Kh. ,   Russian Medical Academy of Continuous Professional Education, 2/1 Barrikadnaya St., bldg 1, Moscow, 125993, Russian Federation, Rabikova D.N. ,   he Russian Register of Potentially Hazardous Chemical and Biological Substances – the branch of F.F. Erisman Federal Scientific Center of Hygiene of the Rospotrebnadzor, 8 Bagrationovskii passage, bldg 2, Moscow, 121087, Russian Federation,   Russian Medical Academy of Continuous Professional Education, 2/1 Barrikadnaya St., bldg 1, Moscow, 125993, Russian Federation, Tarasova E.V. ,   he Russian Register of Potentially Hazardous Chemical and Biological Substances – the branch of F.F. Erisman Federal Scientific Center of Hygiene of the Rospotrebnadzor, 8 Bagrationovskii passage, bldg 2, Moscow, 121087, Russian Federation, Sinitskaya T.A. ,   F.F. Erisman Federal Scientific Center of Hygiene of the Rospotrebnadzor, 2 Semashko St., Mytishchi, Moscow region, 141000, Russian Federation, Zamkova I.V. ,   he Russian Register of Potentially Hazardous Chemical and Biological Substances – the branch of F.F. Erisman Federal Scientific Center of Hygiene of the Rospotrebnadzor, 8 Bagrationovskii passage, bldg 2, Moscow, 121087, Russian Federation, Nazarenko A.K. ,   he Russian Register of Potentially Hazardous Chemical and Biological Substances – the branch of F.F. Erisman Federal Scientific Center of Hygiene of the Rospotrebnadzor, 8 Bagrationovskii passage, bldg 2, Moscow, 121087, Russian Federation,   D.I. Mendeleev Russian Chemical Technical University, 9 Miusskaya square, bldg 6, Moscow, 125047, Russian Federation
Published: January 2025

There are no lists of chemicals with mutagenic effects in the Russian Federation and in the states of the Eurasian Economic Union. Therefore, within the framework of the program ‘Development of integrated approaches to testing, assessing hazards and risk of exposure to chemicals for human health and improvement of the evidence base of toxicological research results’ (deadlines: 2024–2025), the Russian Register of Potentially Hazardous Chemical and Biological Substances – Branch of F.F. Erisman Federal Scientific Center of Hygiene of the Rospotrebnadzor has completed several work tasks concerning selection of substances with mutagenic effects, assessment and classification of their hazard.

Data available in international legislation, documents issued by the United Nations structures, scientific articles, monographs, and official national and foreign databases were analyzed in order to identify candidate substances with genotoxic/mutagenic effects and to form their toxicological profiles to assess the degree of hazard. Classifications of potential mutagens were based on the principles stated in the Globally Harmonized System of Classification and Labeling of Chemicals and Mixtures.

Selection of substances, assessment and classification of hazards is a complex process that requires in-depth analysis of the entire set of obtained data. An approach based on the principles of a step-by-step comprehensive assessment and classification of hazards posed by chemicals with mutagenic effects made it possible to scientifically substantiate and form a national list of mutagens. This list was employed as the basis for a number of normative and methodological documents, including Methodological Recommendations ‘Assessment and Classification of the Hazard of Mutagens’, appendices to the Procedure for creating and maintaining a register of chemicals and mixtures of the Eurasian Economic Union Technical Regulations ‘On Safety of Chemical Products’ (TR EAEU 041/2017), as well as the draft national Technical regulation ‘On safety of chemical products’. The official status of the mutagen list will contribute not only to making relevant management decisions but also to resolving disputes arising between the business community and regulatory authorities due to differences in interpretation of research results.