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<article article-type="research-article" dtd-version="1.3" xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xml:lang="ru"><front><journal-meta><journal-id journal-id-type="publisher-id">toxreview</journal-id><journal-title-group><journal-title xml:lang="ru">Токсикологический вестник</journal-title><trans-title-group xml:lang="en"><trans-title>Toxicological Review</trans-title></trans-title-group></journal-title-group><issn pub-type="ppub">0869-7922</issn><issn pub-type="epub">3034-4611</issn><publisher><publisher-name>Federal Scientific Center of Hygiene named after F.F. Erisman</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="doi">10.47470/0869-7922-2025-33-6-502-512</article-id><article-id custom-type="edn" pub-id-type="custom">xexviy</article-id><article-id custom-type="elpub" pub-id-type="custom">toxreview-1046</article-id><article-categories><subj-group subj-group-type="heading"><subject>Research Article</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="ru"><subject>ХИМИЧЕСКАЯ БЕЗОПАСНОСТЬ</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="en"><subject>CHEMICAL SAFETY</subject></subj-group></article-categories><title-group><article-title>Особенности формирования доказательной базы при оценке и классификации опасности химических веществ по специфическим и отдалённым эффектам</article-title><trans-title-group xml:lang="en"><trans-title>Features of the evidence base formation for the assessment and classification of the hazards of chemicals based on specific and long-term effects</trans-title></trans-title-group></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0001-7319-5337</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Хамидулина</surname><given-names>Халидя Хизбулаевна</given-names></name><name name-style="western" xml:lang="en"><surname>Khamidulina</surname><given-names>Khalidya Kh.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Доктор мед. наук, профессор, главный научный сотрудник, руководитель Научного информационно-аналитического центра РПОХБВ ФБУН «ФНЦГ им. Ф.Ф. Эрисмана» Роспотребнадзора, 121087, Москва, Россия; профессор, заведующая кафедрой гигиены ФГБОУ ДПО РМАНПО Минздрава России, 125993, Москва, Россия</p><p>e-mail: khalidiya@yandex.ru</p></bio><bio xml:lang="en"><p>Doctor of Medical Sciences, Professor, Chief Researcher, Head of the Scientific Information and Analytical Center “Russian Register of Potentially Hazardous Chemical and Biological Substances” of the F.F. Erisman Federal Scientific Center of Hygiene, Rospotrebnadzor, Moscow, 121087, Russian Federation; Professor, Head of the Department of Hygiene, Russian Medical Academy of Continuous Professional Education, RF Ministry of Health, Moscow, 125993, Russian Federation</p><p>e-mail: khalidiya@yandex.ru</p></bio><email xlink:type="simple">khalidiya@yandex.ru</email><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-4020-3123</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Тарасова</surname><given-names>Елена Владимировна</given-names></name><name name-style="western" xml:lang="en"><surname>Tarasova</surname><given-names>Elena V.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Кандидат хим. наук, старший научный сотрудник, зам. руководителя Научного информационно-аналитического центра РПОХБВ ФБУН «ФНЦГ им. Ф.Ф. Эрисмана» Роспотребнадзора, 121087, Москва, Россия</p><p>e-mail: tarasova.ev@fncg.ru</p></bio><bio xml:lang="en"><p>Candidate of Chemical Sciences, Senior Resarcher, Deputy Head of the Scientific Information and Analytical Center “Russian Register of Potentially Hazardous Chemical and Biological Substances” of the F.F. Erisman Federal Scientific Center of Hygiene, Rospotrebnadzor, Moscow, 121087, Russian Federation</p><p>e-mail: tarasova.ev@fncg.ru</p></bio><email xlink:type="simple">tarasova.ev@fncg.ru</email><xref ref-type="aff" rid="aff-2"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0003-0178-4540</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Назаренко</surname><given-names>Андрей Константинович</given-names></name><name name-style="western" xml:lang="en"><surname>Nazarenko</surname><given-names>Andrey K.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Химик-эксперт, младший научный сотрудник Научного информационно-аналитического центра РПОХБВ ФБУН «ФНЦГ им. Ф.Ф. Эрисмана» Роспотребнадзора, 121087, Москва, Россия</p><p>e-mail: nazarenko.ak@fncg.ru</p></bio><bio xml:lang="en"><p>Expert Chemist, Junior Researcher of the Scientific Information and Analytical Center “Russian Register of Potentially Hazardous Chemical and Biological Substances” of the F.F. Erisman Federal Scientific Center of Hygiene, Rospotrebnadzor, Moscow, 121087, Russian Federation</p><p>e-mail: nazarenko.ak@fncg.ru</p></bio><email xlink:type="simple">nazarenko.ak@fncg.ru</email><xref ref-type="aff" rid="aff-2"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0009-0006-9756-3521</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Тверская</surname><given-names>Анастасия Сергеевна</given-names></name><name name-style="western" xml:lang="en"><surname>Tverskaya</surname><given-names>Anastasia S.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Специалист по международным отношениям Научного информационно-аналитического центра РПОХБВ ФБУН «ФНЦГ им. Ф.Ф. Эрисмана» Роспотребнадзора, 121087, Москва, Россия</p><p>e-mail: tverskaya.as@fncg.ru</p></bio><bio xml:lang="en"><p>Foreign Affairs Specialist of the Scientific Information and Analytical Center “Russian Register of Potentially Hazardous Chemical and Biological Substances” of the F.F. Erisman Federal Scientific Center of Hygiene, Rospotrebnadzor, Moscow, 121087, Russian Federation</p><p>e-mail: tverskaya.as@fncg.ru</p></bio><email xlink:type="simple">tverskaya.as@fncg.ru</email><xref ref-type="aff" rid="aff-2"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0001-8901-7914</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Дорофеева</surname><given-names>Екатерина Валентиновна</given-names></name><name name-style="western" xml:lang="en"><surname>Dorofeeva</surname><given-names>Ekaterina V.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Начальник информационно-аналитического отдела; врач по общей гигиене Научного информационно-аналитического центра РПОХБВ ФБУН «ФНЦГ им. Ф.Ф. Эрисмана» Роспотребнадзора, 121087, Москва, Россия</p><p>e-mail: dorofeeva.ev@fncg.ru</p></bio><bio xml:lang="en"><p>Head of the Information and Analytical Department, General Hygiene Doctor of the Scientific Information and Analytical Center “Russian Register of Potentially Hazardous Chemical and Biological Substances” of the F.F. Erisman Federal Scientific Center of Hygiene, Rospotrebnadzor, Moscow, 121087, Russian Federation</p><p>e-mail: dorofeeva.ev@fncg.ru</p></bio><email xlink:type="simple">dorofeeva.ev@fncg.ru</email><xref ref-type="aff" rid="aff-2"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-7959-7246</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Замкова</surname><given-names>Ирина Валентиновна</given-names></name><name name-style="western" xml:lang="en"><surname>Zamkova</surname><given-names>Irina V.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Врач по санитарно-гигиеническим лабораторным исследованиям Научного информационно-аналитического центра РПОХБВ ФБУН «ФНЦГ им. Ф.Ф. Эрисмана» Роспотребнадзора, 121087, Москва, Россия</p><p>e-mail: zamkova.iv@fncg.ru</p></bio><bio xml:lang="en"><p>Doctor of Sanitary and Hygienic Laboratory Tests of the Scientific Information and Analytical Center “Russian Register of Potentially Hazardous Chemical and Biological Substances” of the F.F. Erisman Federal Scientific Center of Hygiene, Rospotrebnadzor, Moscow, 121087, Russian Federation</p><p>e-mail: zamkova.iv@fncg.ru</p></bio><email xlink:type="simple">zamkova.iv@fncg.ru</email><xref ref-type="aff" rid="aff-2"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0003-2124-6440</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Проскурина</surname><given-names>Ангелина Сергеевна</given-names></name><name name-style="western" xml:lang="en"><surname>Proskurina</surname><given-names>Angelina S.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Врач по общей гигиене, младший научный сотрудник Научного информационно-аналитического центра РПОХБВ ФБУН «ФНЦГ им. Ф.Ф. Эрисмана» Роспотребнадзора, 121087, Москва, Россия; ассистент кафедры гигиены ФГБОУ ДПО РМАНПО Минздрава России, 125993, Москва, Россия</p><p>e-mail: proskurina.as@fncg.ru</p></bio><bio xml:lang="en"><p>General Hygiene Doctor, Junior Researcher of the Scientific Information and Analytical Center “Russian Register of Potentially Hazardous Chemical and Biological Substances” of the F.F. Erisman Federal Scientific Center of Hygiene, Rospotrebnadzor, Moscow, 121087, Russian Federation; Assistant of the Department of Hygiene, Russian Medical Academy of Continuous Professional Education, RF Ministry of Health, Moscow, 125993, Russian Federation</p><p>e-mail: proskurina.as@fncg.ru</p></bio><email xlink:type="simple">proskurina.as@fncg.ru</email><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0003-3965-7600</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Рабикова</surname><given-names>Динара Нуруллаевна</given-names></name><name name-style="western" xml:lang="en"><surname>Rabikova</surname><given-names>Dinara N.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Начальник организационно-методического отдела, врач по общей гигиене, старший научный сотрудник Научного информационно-аналитического центра РПОХБВ ФБУН «ФНЦГ им. Ф.Ф. Эрисмана» Роспотребнадзора, 121087, Москва, Россия; ассистент кафедры гигиены ФГБОУ ДПО РМАНПО Минздрава России, 125993, Москва, Россия</p><p>e-mail: rabikova.dn@fncg.ru</p></bio><bio xml:lang="en"><p>Head of the Organizational and Methodological Department, General Hygiene Doctor, Senior Researcher of the Scientific Information and Analytical Center “Russian Register of Potentially Hazardous Chemical and Biological Substances” of the F.F. Erisman Federal Scientific Center of Hygiene, Rospotrebnadzor, Moscow, 121087, Russian Federation; Assistant at the Department of Hygiene of the Department of Hygiene, Russian Medical Academy of Continuous Professional Education, RF Ministry of Health, Moscow, 125993, Russian Federation</p><p>e-mail: rabikova.dn@fncg.ru</p></bio><email xlink:type="simple">rabikova.dn@fncg.ru</email><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0001-9887-0626</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Ластовецкий</surname><given-names>Михаил Леонидович</given-names></name><name name-style="western" xml:lang="en"><surname>Lastovetskiy</surname><given-names>Mikhail L.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Химик-эксперт, младший научный сотрудник Научного информационно-аналитического центра РПОХБВ ФБУН «ФНЦГ им. Ф.Ф. Эрисмана» Роспотребнадзора, 121087, Москва, Россия</p><p>e-mail: lastovetskiy.ml@fncg.ru</p></bio><bio xml:lang="en"><p>Expert Chemist, Junior Researcher of the Scientific Information and Analytical Center “Russian Register of Potentially Hazardous Chemical and Biological Substances” of the F.F. Erisman Federal Scientific Center of Hygiene, Rospotrebnadzor, Moscow, 121087, Russian Federation</p><p>e-mail: lastovetskiy.ml@fncg.ru</p></bio><email xlink:type="simple">lastovetskiy.ml@fncg.ru</email><xref ref-type="aff" rid="aff-2"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0001-7694-0646</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Арасланов</surname><given-names>Ильгиз Наилевич</given-names></name><name name-style="western" xml:lang="en"><surname>Araslanov</surname><given-names>Ilgiz N.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Врач по общей гигиене, младший научный сотрудник Научного информационно-аналитического центра РПОХБВ ФБУН «ФНЦГ им. Ф.Ф. Эрисмана» Роспотребнадзора, 121087, Москва, Россия</p><p>e-mail: araslanov.in@fncg.ru</p></bio><bio xml:lang="en"><p>General Hygiene Doctor, Junior Researcher of the Scientific Information and Analytical Center “Russian Register of Potentially Hazardous Chemical and Biological Substances” of the F.F. Erisman Federal Scientific Center of Hygiene, Rospotrebnadzor, Moscow, 121087, Russian Federation</p><p>e-mail: araslanov.in@fncg.ru</p></bio><email xlink:type="simple">araslanov.in@fncg.ru</email><xref ref-type="aff" rid="aff-2"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-6384-0408</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Аниськова</surname><given-names>Юлия Юрьевна</given-names></name><name name-style="western" xml:lang="en"><surname>Aniskova</surname><given-names>Yulia Yu.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Врач по общей гигиене Научного информационно-аналитического центра РПОХБВ ФБУН «ФНЦГ им. Ф.Ф. Эрисмана» Роспотребнадзора, 121087, Москва, Россия</p><p>e-mail: aniskova.yuyu@fncg.ru</p></bio><bio xml:lang="en"><p>General Hygiene Doctor of the Scientific Information and Analytical Center “Russian Register of Potentially Hazardous Chemical and Biological Substances” of the F.F. Erisman Federal Scientific Center of Hygiene, Rospotrebnadzor, Moscow, 121087, Russian Federation</p><p>e-mail: aniskova.yuyu@fncg.ru</p></bio><email xlink:type="simple">aniskova.yuyu@fncg.ru</email><xref ref-type="aff" rid="aff-2"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0009-0001-9233-7430</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Балашов</surname><given-names>Пётр Евгеньевич</given-names></name><name name-style="western" xml:lang="en"><surname>Balashov</surname><given-names>Peter E.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Специалист организационно-методического отдела Научного информационно-аналитического центра РПОХБВ ФБУН «ФНЦГ им. Ф.Ф. Эрисмана» Роспотребнадзора, 121087, Москва, Россия</p><p>e-mail: balashov.pe@fncg.ru</p></bio><bio xml:lang="en"><p>Specialist at the Organizational and Methodological Department of the Scientific Information and Analytical Center “Russian Register of Potentially Hazardous Chemical and Biological Substances” of the F.F. Erisman Federal Scientific Center of Hygiene, Rospotrebnadzor, Moscow, 121087, Russian Federation</p><p>e-mail: balashov.pe@fncg.ru</p></bio><email xlink:type="simple">balashov.pe@fncg.ru</email><xref ref-type="aff" rid="aff-2"/></contrib></contrib-group><aff-alternatives id="aff-1"><aff xml:lang="ru"><institution>НИАЦ «Российский регистр потенциально опасных химических и биологических веществ» ФБУН «Федеральный научный центр гигиены им. Ф.Ф. Эрисмана» Роспотребнадзора; ФГБОУ ДПО «Российская медицинская академия непрерывного профессионального образования» Министерства здравоохранения Российской Федерации</institution><country>Россия</country></aff><aff xml:lang="en"><institution>Scientific Information and Analytical Center “Russian Register of Potentially Hazardous Chemical and Biological Substances” of the F.F. Erisman Federal Scientific Center of Hygiene, Rospotrebnadzor; Russian Medical Academy of Continuous Professional Education, RF Ministry of Health</institution><country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-2"><aff xml:lang="ru"><institution>НИАЦ «Российский регистр потенциально опасных химических и биологических веществ» ФБУН «Федеральный научный центр гигиены им. Ф.Ф. Эрисмана» Роспотребнадзора</institution><country>Россия</country></aff><aff xml:lang="en"><institution>Scientific Information and Analytical Center “Russian Register of Potentially Hazardous Chemical and Biological Substances” of the F.F. Erisman Federal Scientific Center of Hygiene, Rospotrebnadzor</institution><country>Russian Federation</country></aff></aff-alternatives><pub-date pub-type="collection"><year>2025</year></pub-date><pub-date pub-type="epub"><day>22</day><month>01</month><year>2026</year></pub-date><volume>33</volume><issue>6</issue><fpage>502</fpage><lpage>512</lpage><permissions><copyright-statement>Copyright &amp;#x00A9; Хамидулина Х.Х., Тарасова Е.В., Назаренко А.К., Тверская А.С., Дорофеева Е.В., Замкова И.В., Проскурина А.С., Рабикова Д.Н., Ластовецкий М.Л., Арасланов И.Н., Аниськова Ю.Ю., Балашов П.Е., 2026</copyright-statement><copyright-year>2026</copyright-year><copyright-holder xml:lang="ru">Хамидулина Х.Х., Тарасова Е.В., Назаренко А.К., Тверская А.С., Дорофеева Е.В., Замкова И.В., Проскурина А.С., Рабикова Д.Н., Ластовецкий М.Л., Арасланов И.Н., Аниськова Ю.Ю., Балашов П.Е.</copyright-holder><copyright-holder xml:lang="en">Khamidulina K.K., Tarasova E.V., Nazarenko A.K., Tverskaya A.S., Dorofeeva E.V., Zamkova I.V., Proskurina A.S., Rabikova D.N., Lastovetskiy M.L., Araslanov I.N., Aniskova Y.Y., Balashov P.E.</copyright-holder><license xml:lang="ru" license-type="creative-commons-attribution" xlink:href="https://creativecommons.org/licenses/by/4.0/" xlink:type="simple"><license-p>Данная работа распространяется под лицензией Creative Commons Attribution 4.0.</license-p></license><license xml:lang="en" license-type="creative-commons-attribution" xlink:href="https://creativecommons.org/licenses/by/4.0/" xlink:type="simple"><license-p>This work is licensed under a Creative Commons Attribution 4.0 License.</license-p></license></permissions><self-uri xlink:href="https://www.toxreview.ru/jour/article/view/1046">https://www.toxreview.ru/jour/article/view/1046</self-uri><abstract><sec><title>Введение</title><p>Введение. Для устранения трудностей, возникающих при классификации химических веществ по специфическим и отдалённым эффектам в соответствии с Согласованной на глобальном уровне системой классификации и маркировки химической продукции (СГС), НИАЦ РПОХБВ ФБУН «ФНЦГ им. Ф.Ф. Эрисмана» Роспотребнадзора разработал алгоритм принятия решений с учётом весомости доказательств. Он включает систематическую оценку всех имеющихся данных, как подтверждающих, так и опровергающих наличие эффекта, и определение их вклада (от 1 до 3 баллов) по критериям: достоверность, согласованность, биологическая правдоподобность, зависимость «доза – эффект», сопоставимость эффекта, наблюдаемого у животных, с потенциальными последствиями для здоровья человека. Доказательства ранжируются по сумме баллов, при оценке и классификации опасности химического вещества по СГС приоритетными являются доказательства с наименьшим количеством баллов. Алгоритм применим для всех видов эффектов, в том числе канцерогенности, мутагенности, репротоксичности, сенсибилизации, воздействия на эндокринную систему.</p><p>Цель исследования заключалась в демонстрации подходов к формированию доказательной базы при оценке и классификации опасности химических веществ по специфическим и отдалённым эффектам с учётом особенностей данных видов воздействия.</p></sec><sec><title>Материал и методы</title><p>Материал и методы. Проведён анализ национальных и международных подходов к формированию доказательной базы при оценке и классификации опасности химических веществ, обладающих специфическими и отдалёнными эффектами.</p></sec><sec><title>Результаты</title><p>Результаты. Описаны особенности использования алгоритма принятия решений при оценке мутагенного, канцерогенного, репротоксического, сенсибилизирующего эффекта и воздействия химических веществ на эндокринную систему, а также порядок применения соответствующих методов тестирования и интерпретации результатов.</p></sec><sec><title>Ограничения исследования</title><p>Ограничения исследования. Исследование ограничено анализом открытых литературных источников, в том числе баз данных Scopus, Web of Science, PubMed, ResearchGate, Cyberleninka, РИНЦ, eLIBRARY.</p></sec><sec><title>Заключение</title><p>Заключение. Представлены принципиальные схемы формирования доказательных баз при оценке и классификации опасности химических веществ по специфическим и отдалённым эффектам с учётом особенностей данных видов воздействия, что способствует надёжности принятия решений и их прозрачности.</p><p>Соблюдение этических стандартов. Исследование не требует предоставления заключения Комиссии по биоэтике.</p></sec><sec><title>Участие авторов</title><p>Участие авторов: Хамидулина Х.Х., Тарасова Е.В. – концепция и дизайн исследования, редактирование, утверждение окончательного варианта статьи, ответственность за целостность всех частей статьи; Назаренко А.К., Тверская А.С., Дорофеева Е.В., Замкова И.В., Проскурина А.С., Рабикова Д.Н., Ластовецкий М.Л., Арасланов И.Н., Аниськова Ю.Ю., Балашов П.Е. – сбор и обработка материала, написание текста, редактирование.</p></sec><sec><title>Конфликт интересов</title><p>Конфликт интересов. Авторы заявляют об отсутствии явных и потенциальных конфликтов интересов в связи с публикацией данной статьи.</p></sec><sec><title>Финансирование</title><p>Финансирование. Исследование выполнено в рамках реализации научно-исследовательской работы «Валидация альтернативных методов исследования при оценке опасности и риска воздействия химических веществ на здоровье человека в качестве инструмента регулирования безопасности химического фактора» по отраслевой научно-исследовательской программе по гигиене на 2024–2025 гг.</p></sec><sec><title>Поступила в редакцию</title><p>Поступила в редакцию: 05 ноября 2025 / Принята к печати: 25 ноября 2025 / Опубликована: 15 января 2026</p></sec></abstract><trans-abstract xml:lang="en"><sec><title>Introduction</title><p>Introduction. To eliminate the difficulties encountered in classifying chemicals by specific and long-term effects in accordance with the GHS, the Scientific Information and Analytical Center “Russian Register of Potentially Hazardous Chemical and Biological Substances” has developed a decision-making algorithm based on the weight of evidence. It includes a systematic assessment of the full range of available data, both confirming and refuting the effect, taking into account their contribution (from 1 to 3 points) according to the criteria of reliability, consistency, biological plausibility, dose-effect relationship, comparability of the effect observed in animals with potential consequences for human health. Evidence is ranked by the sum of points, and evidence with the lowest number of points is given priority when assessing and classifying the hazard of a chemical according to the GHS. The algorithm is applicable to all types of effects, including carcinogenicity, mutagenicity, reprotoxicity, sensitization, and effects on the endocrine system.</p><p>The purpose of the study was to demonstrate approaches to the evidence base formation for assessing and classifying the hazards of chemicals by specific and long-term effects, taking into account the characteristics of these types of exposure.</p></sec><sec><title>Material and methods</title><p>Material and methods. The analysis of national and international approaches to the evidence base formation for the assessment and classification of the hazards of chemicals with specific and long-term effects is carried out.</p></sec><sec><title>Results</title><p>Results. The features of using a decision-making algorithm in assessing the mutagenic, carcinogenic, reprotoxic, sensitizing effects and effects of chemicals on the endocrine system are described, as well as the procedure for applying appropriate testing methods and interpreting the results.</p></sec><sec><title>Limitations</title><p>Limitations. The research is limited to the analysis of open literary sources, including databases Scopus, Web of Science, PubMed, ResearchGate, Cyberleninka, RSCI, eLibrary.</p></sec><sec><title>Conclusion</title><p>Conclusion. Basic schemes for the formation of evidence bases for assessing and classifying chemical hazards based on specific and long-term effects were presented, taking into account the characteristics of these types of exposure, which contribute to the transparency and reliability of decision-making.</p><p>Compliance with ethical standards. The study does not require an opinion from the Bioethics Commission.</p></sec><sec><title>Authors’ contribution</title><p>Authors’ contribution: Khamidulina Kh.Kh., Tarasova E.V. – concept and design of the study, editing, approval of the final version of the article, responsibility for the integrity of all parts of the article; Nazarenko A.K., Tverskaya A.S., Dorofeeva E.V., Zamkova I.V., Proskurina A.S., Rabikova D.N., Lastovetskiy M.L., Araslanov I.N., Aniskova Yu. Yu., Balashov P.E. – collecting and processing material, writing text, editing.</p></sec><sec><title>Conflict of interests</title><p>Conflict of interests. The authors declare the absence of obvious and potential conflicts of interest in connection with the publication of this article.</p></sec><sec><title>Funding</title><p>Funding. The study was carried out as part of the research project “Validation of alternative research methods in assessing the hazard and risk of exposure to chemicals on human health as a tool for regulating the safety of chemical factors” under the industry research program on hygiene for 2024–2025.</p></sec><sec><title>Received</title><p>Received: November 5, 2025 / Accepted: November 25, 2025 / Published: January 15, 2026</p></sec></trans-abstract><kwd-group xml:lang="ru"><kwd>химическое вещество</kwd><kwd>специфические и отдалённые эффекты</kwd><kwd>классификация опасности</kwd><kwd>доказательная база</kwd><kwd>алгоритм принятия решений</kwd><kwd>СГС</kwd></kwd-group><kwd-group xml:lang="en"><kwd>chemical substance</kwd><kwd>specific and long-term effects</kwd><kwd>hazard classification</kwd><kwd>evidence base</kwd><kwd>decision-making algorithm</kwd><kwd>GHS</kwd></kwd-group></article-meta></front><back><ref-list><title>References</title><ref id="cit1"><label>1</label><citation-alternatives><mixed-citation xml:lang="ru">Klimisch H.J., Andreae M., Tillmann U. 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