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Tests can be classified as clinical and non-clinical studies.
Clinical studies are carried out on human volunteers, following resolution No. 466, of December 12, 2012, published by the Ministry of Health, which provides for ethics, integrity and free and informed consent on the participation of human beings in research, through a consent form signed by the volunteer.
Clinical studies can only be carried out as the last of all trials, and must undergo approval by the Ethics Committee for human trials.
Non-clinical studies are all those in which humans are not involved, and are generally carried out on cosmetic ingredients to assess the toxicological risk of these ingredients.
Non-clinical trials comprise trials in vivo (in animals), in vitro, in silico, in chemistry.
At this point, new testing approaches with 21st century methodologies (NAMs) are used, as well as toxicological data carried out on animals over the last 100 years recorded in official databases.
To reconcile all these test models and recorded data, with the aim of answering the question: “Is it safe or not safe?”, integrated testing approaches are used along with their assessments (IATA, Integrated Approaches to Testing and Assessment) to each adverse effect, already published by the OECD, and defined approaches (DA, Defined Approaches).
It is worth remembering that the major global trend is the ban on animal testing for cosmetic ingredients and products. But, not all animal testing is replaceable! So what to do?
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- Safety in cosmetics. Because you need to have it.
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