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Skin sensitizers are substances that cause allergic reactions upon repeated contact with the skin.
A number of government agencies require or are requesting the submission of skin sensitization data before products such as cosmetics, pesticides and pharmaceuticals enter the market. In the United States, these agencies include the Consumer Product Safety Commission, the Environmental Protection Agency, the FDA, and the Department of Transportation.
Animal tests
The maximum test in guinea pigs, which is more than 50 years old, involves repeated administration of the test substance to animals. They are monitored for signs of an allergic reaction, including itchy, inflamed, ulcerated, or painful skin.
In a local lymph node assay in mice, a test substance is applied to the ears of mice, which are ultimately killed, so that the lymph nodes near the ears can be removed and their immune response measured. Human appropriate methods that completely exclude animals have been developed and should be used in lieu of these animal tests.
Non-animal tests
In 2021, the Organization for Economic Co-operation and Development (OECD) – an alliance of countries promoting international consistency in the testing, labeling and regulation of chemicals – published an innovative no-animal approach to testing chemicals for skin sensitization. All 38 OECD countries, including the United States, the United Kingdom and the European Union, must adopt this approach for legally required chemical toxicity testing.
This approach combines several non-animal tests into one formal, defined approach to testing chemicals for their ability to cause an allergic reaction on the skin. The individual tests used within the approach assess various aspects of skin sensitization. For example, direct peptide reactivity analysis tests whether some of the events required for an allergic reaction occur in response to a chemical in a test tube. Another non-animal test, KeratinoSens, allows a chemical to be added to a layer of human cells that react in a specific way if the chemical causes an adverse reaction on human skin.
These tests are animal-friendly and have been shown to predict human responses as well as animal tests, or even more so.
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