Skin sensitization test to detect keratinocyte activation
Validated Method CompanyXCellR8, Daresbury, United Kingdom
The company's XCellR8 regulatory skin sensitization test KeratinoSens™ (OECD TG 442D) 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 test was specifically designed to measure keratinocyte activation in the epidermis (key event 2). The human keratinocyte cell line used for the test contains a sensitizer-sensitive gene linked to the bioluminescent enzyme luciferase. Skin allergenic substances induce overexpression of the luciferase gene, which is measured quantitatively using luminescence detection methods. Test substances that have an enzyme activity of ≥ 1.5 compared to the untreated control level are classified as sensitizers. Substances with lower values are considered non-sensitizers. The method is recognized by the UN-GHS and complies with EU regulations on the safety of cosmetic and chemical products. In summary, the KeratinoSens™ skin sensitization test proves to be a safe and sensitive method for detecting allergenic substances that can help improve safety testing in drug, cosmetic and chemical development. Validated and regulatory recognized under OECD Test No. 442D.
Regulatory KeratinoSens™ Skin sensitisation test
info@x-cellr8.com
Added on: 02-27-2024
[1] https://www.oecd-ilibrary.org/environment/test-no-442d-in-vitro-skin-sensitisation_9789264229822-en[2] https://x-cellr8.com/regulatory-safety-testing/skin-sensitisation-testing/keratinosens-oecd-tg-442d/
