Skin sensitization test to detect the local immune response
Regulatory accepted CompanyXCellR8, Daresbury, United Kingdom
The XCellR8 human cell activation test (h-CLAT) is part of an integrated approach for the reliable detection of allergenic substances that induce various key events in the cells of the skin. The h-CLAT test was specifically developed to assess the activation of dendritic cells (DC) in the epidermis (key event 3), which in turn is associated with increased gene expression of the cell surface proteins CD54 and CD 86. To detect this event, the test substances are incubated for 24 hours with a human monocytic leukemia cell line (THP-1). The cells are then stained with fluorochrome and the change in gene expression of the surface cell markers is determined quantitatively using flow cytometry. In parallel, a cytotoxicity measurement is carried out to assess whether upregulation of surface proteins can also be observed at subcytotoxic concentrations. The calculated relative fluorescence intensity of the cell markers serves as a parameter for categorical classification of the substance examined into sensitizer (positive for upregulation of CD54/CD86 expression) and non-sensitizer (negative for upregulation of CD54/CD86 expression). The validated method is fully recognized by the UN-GHS and complies with a number of different EU safety regulations, such as REACH (EC 1907/2006), the Cosmetics Regulation (EC 1223/2009), the CLP Regulation (EC 1272/2008), the Biocidal Products Regulation (EC 528/2012), as well as the Plant Protection Products Regulation (EC 1107/2009). In summary, the h-CLAT skin sensitization test proves to be a safe and effective method for assessing the local immune response, which can help optimize safety testing procedures in the field of drug, cosmetic and chemical development. Validated and regulatory recognized under OECD Test No. 442E.
Regulatory h-CLAT skin sensitisation test
info@x-cellr8.com
Added on: 02-27-2024
[1] https://www.oecd.org/env/test-no-442e-in-vitro-skin-sensitisation-9789264264359-en.htm[2] https://x-cellr8.com/regulatory-safety-testing/skin-sensitisation-testing/hclat-testing-oecd-tg-442e/
