Альтернативные методы оценки локальной токсичности парфюмерно-косметической продукции – реальный шаг вперед или косметическая мера?
Аннотация
В условиях давления на использование лабораторных животных при испытаниях парфюмерно-косметической продукции (ПКП) возрастает значение альтернативных методов (АМ) in vitro, ex vivo и in chemico. В этой связи в 2023 г. технический регламент таможенного союза ТР ТС 009/2011 «О безопасности парфюмерно-косметической продукции» (ТР ТС 009/2011) был дополнен перечнем стандартов, включающих ряд АМ. Цель данного исследования – оценка возможности применения АМ для подтверждения соответствия ПКП требованиям ТР ТС 009/2011 по токсикологическим показателям: кожно-раздражающее действие, раздражающее действие на слизистые и сенсибилизирующее действие. Проведено сопоставление in vivo методов для оценки кожно-раздражающего действия ПКП и ее раздражающего действия на слизистые с in vivo методами, используемыми при классификации химической продукции (ХП) по видам опасности разъедание / раздражение кожи, серьезное повреждение/раздражение глаз. Выполнен сравнительный анализ пороговых значений токсикологических показателей, установленных ТР ТС 009/2011, и классификационных рамок классов соответствующих им видов опасности в Согласованной на глобальном уровне системе классификации и маркировки химической продукции (СГС), а также оценена дифференцирующая способность АМ. Установлены существенные различия между критериями ТР ТС 009/2011 и СГС, обусловленные как более жесткими требованиями безопасности к ПКП, так и особенностями ее применения. Показано, что in vivo методы для ХП неэквивалентны методам оценки ПКП. Выявлена недостаточная дифференцирующая способность большинства проанализированных АМ. Сделан вывод о том, что применение АМ для оценки риска ПКП затруднено. Обоснована необходимость дополнения методик расчета индекса кожно-раздражающего действия Icut, а также индекса раздражающего действия на слизистые Iir. Предложены направления по актуализации Приложений № 8 и № 9 ТР ТС 009/2011 и разработке АМ с повышенной дифференцирующей способностью. Рассмотрена роль АМ при оценке сенсибилизирующего потенциала ПКП.
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