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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">10.36946/0869-7922-2021-29-6-5-15</article-id><article-id custom-type="elpub" pub-id-type="custom">toxreview-567</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>ОБЗОРЫ</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="en"><subject>REVIEWS</subject></subj-group></article-categories><title-group><article-title>Методологические основы обоснования безопасных уровней воздействия искусственных наноматериалов (на примере углеродных нанотрубок) (обзор литературы)</article-title><trans-title-group xml:lang="en"><trans-title>Methodological foundations for substantiating safe levels of exposure to artificial nanomaterials (for example, carbon nanotubes) (literature review)</trans-title></trans-title-group></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-2479-2474</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Тимербулатова</surname><given-names>Гюзель Абдулхалимовна</given-names></name><name name-style="western" xml:lang="en"><surname>Timerbulatova</surname><given-names>Gyuzel A.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Ассистент кафедры гигиены, медицины труда ФГБОУ ВО Казанский государственный медицинский университет Минздрава России (420012, г. Казань, Российская Федерация), врач по общей гигиене отдела социально-гигиенического мониторинга ФБУЗ «Центр гигиены и эпидемиологии в Республике Татарстан (Татарстан)» (420061, г. Казань, Российская Федерация)</p><p>e-mail: ragura@mail.ru</p></bio><email xlink:type="simple">ragura@mail.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/0000-0001-9506-563X</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Фатхутдинова</surname><given-names>Лилия Минвагизовна</given-names></name><name name-style="western" xml:lang="en"><surname>Fatkhutdinova</surname><given-names>Liliya M.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Профессор, доктор мед. наук, профессор, зав. кафедрой гигиены, медицины труда ФГБОУ ВО «Казанский ГМУ» МЗ РФ, г. Казань, 420012, Российская Федерация.</p><p>e-mail: liliya.fatkhutdinova@gmail.com</p></bio><bio xml:lang="en"><p>MD, PhD, DSc, head of the Department of Hygiene and Occupational Medicine, Kazan State Medical University of the Ministry of Health of Russia, Kazan.</p><p>e-mail: liliya.fatkhutdinova@gmail.com</p></bio><email xlink:type="simple">liliya.fatkhutdinova@gmail.com</email><xref ref-type="aff" rid="aff-2"/></contrib></contrib-group><aff-alternatives id="aff-1"><aff xml:lang="ru"><institution>ФГБОУ ВО «Казанский государственный медицинский университет» Министерства здравоохранения Российской Федерации; ФБУЗ «Центр гигиены и эпидемиологии в Республике Татарстан»</institution><country>Россия</country></aff><aff xml:lang="en"><institution>Kazan State Medical University; FBUZ «The Center of Hygiene and Epidemiology in the Republic of Tatarstan»</institution><country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-2"><aff xml:lang="ru"><institution>ФГБОУ ВО «Казанский государственный медицинский университет» Министерства здравоохранения Российской Федерации</institution><country>Россия</country></aff><aff xml:lang="en"><institution>Kazan State Medical University</institution><country>Russian Federation</country></aff></aff-alternatives><pub-date pub-type="collection"><year>2021</year></pub-date><pub-date pub-type="epub"><day>23</day><month>12</month><year>2021</year></pub-date><volume>29</volume><issue>6</issue><fpage>5</fpage><lpage>15</lpage><permissions><copyright-statement>Copyright &amp;#x00A9; Тимербулатова Г.А., Фатхутдинова Л.М., 2021</copyright-statement><copyright-year>2021</copyright-year><copyright-holder xml:lang="ru">Тимербулатова Г.А., Фатхутдинова Л.М.</copyright-holder><copyright-holder xml:lang="en">Timerbulatova G.A., Fatkhutdinova L.M.</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/567">https://www.toxreview.ru/jour/article/view/567</self-uri><abstract><sec><title>Введение</title><p>Введение. Уникальные физико-химические свойства углеродных нанотрубок позволяют использовать их во многих сферах. Ежегодно наблюдается рост глобального рынка наноматериалов. Важным шагом при выведении продукции на внутренний и мировые рынки является определение безопасных уровней воздействия УНТ. Предварительным этапом перед утверждением государственного гигиенического норматива может служить установление корпоративного норматива. </p></sec><sec><title>Материал и методы</title><p>Материал и методы. Материалом для анализа послужили источники сведений об имеющихся нормативах содержания УНТ в воздухе рабочей зоны с использованием информации регуляторных агентств, научно-исследовательских центров, производителей УНТ, библиографических и реферативных баз данных Web of Science, Scopus, PubMed, РИНЦ.</p></sec><sec><title>Результаты</title><p>Результаты. Разработана схема обоснования безопасных уровней воздействия УНТ (корпоративного норматива), состоящая из нескольких этапов: характеризация УНТ в воздухе на рабочих местах, подбор экспериментальных доз УНТ, подготовка дисперсий УНТ, проведение токсиколого-гигиенических экспериментов. Обоснование корпоративного норматива проводится в экспериментах in vitro и in vivo. Планирование экспериментов должно осуществляться с учётом органа-мишени при воздействии УНТ — дыхательная система. Рекомендуемый диапазон доз/концентраций для экспериментов должен включать в себя дозы/концентрации, полученные на основании расчётных и литературных данных. Необходимым этапом является получение гомогенных дисперсий, в которых УНТ становятся биодоступными для биологических систем. В ходе экспериментов in vitro и in vivo определяется уровень воздействия, при котором не наблюдается вредный эффект и/или наименьший уровень воздействия; при котором наблюдается вредный эффект на клеточные культуры/дыхательные пути животных. После этапа обоснования корпоративного норматива на предприятии в течение нескольких лет должны проводиться мероприятия по корректировке корпоративного норматива на основе данных клинико-гигиенических исследований, в ходе которых проводится мониторинг условий труда и состояния здоровья работников и расширенных токсиколого-гигиенических исследований.</p></sec><sec><title>Заключение</title><p>Заключение. Наличие корпоративного норматива позволит предприятию-производителю УНТ провести мероприятия по разработке и реализации программы производственного контроля с внедрением мониторинга за состоянием воздуха рабочей зоны. Разработка корпоративного норматива может рассматриваться как подготовительный этап перед установкой государственного норматива.</p></sec></abstract><trans-abstract xml:lang="en"><sec><title>Introduction</title><p>Introduction. The unique physicochemical properties of carbon nanotubes allow them to be used in many fields. The global nanomaterials market is growing every year. An important step in introducing products to the domestic and world markets is to determine the safe exposure levels of CNTs. Establishing a corporate standard can serve as a preliminary stage before the approval of a state hygiene standard. </p></sec><sec><title>Material and methods</title><p>Material and methods. The material for the analysis was the sources of information on the available standards for the content of CNTs in the air of the working area using information from regulatory agencies, research centers, CNT manufacturers, bibliographic and abstract databases Web of Science, Scopus, PubMed, RSCI.</p></sec><sec><title>Results</title><p>Results. A scheme for justifying safe levels of exposure to CNTs (corporate standard) has been developed, consisting of several stages: characterization of CNTs in the air at workplaces, selection of experimental doses of CNTs, preparation of CNT dispersions, and conducting toxicological and hygienic experiments. Justification of the corporate standard is carried out in in vitro and in vivo experiments. The planning of experiments should be carried out taking into account the target organ under the influence of CNT — the respiratory system. The recommended dose / concentration range for experiments should include doses / concentrations derived from calculated and literature data. A necessary step is to obtain homogeneous dispersions in which CNTs become bioavailable for biological systems. In vitro and in vivo experiments determine the level of exposure at which no harmful effect is observed and / or the lowest level of exposure at which there is a harmful effect on the cell culture / respiratory tract of animals. After the stage of substantiating the corporate standard, the enterprise should take measures for several years to adjust the corporate standard based on data from clinical and hygienic studies, during which the working conditions and health status of workers are monitored, and extended toxicological and hygienic studies. </p></sec><sec><title>Conclusion</title><p>Conclusion. The presence of a corporate standard will allow the manufacturer of CNTs to carry out activities for the development and implementation of a production control program with the introduction of monitoring the air condition in the working area. The development of a corporate regulation can be seen as a preparatory stage before the establishment of a government regulation.</p></sec></trans-abstract><kwd-group xml:lang="ru"><kwd>углеродные нанотрубки</kwd><kwd>безопасные уровни воздействия</kwd><kwd>корпоративный норматив</kwd><kwd>in vitro</kwd><kwd>in vivo</kwd></kwd-group><kwd-group xml:lang="en"><kwd>carbon nanotubes</kwd><kwd>safe exposure levels</kwd><kwd>corporate standard</kwd><kwd>in vitro</kwd><kwd>in vivo</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">Global Markets and Technologies for Carbon Nanotubes - 2015. BCC Research. Market forecasting. 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