Reconstructed corneal epithelium for regulatory skin irritation testing
Validated Method CompanyXCellR8, Daresbury, United Kingdom
The company's XCellR8 skin irritation test is based on a highly differentiated reconstructed human corneal epithelium (RhCE), which validly recapitulates the structural and functional properties of the skin. The epithelial models are cultivated in special cultivation systems at an air-liquid interface, which enables the test substances to be applied directly to the cells. After an incubation lasting several hours, the viability of the corneal cells is quantitatively determined using MTT conversion. If the viability is ≤ 50%, the substance examined is classified as skin irritant (UN GHS category 2 / EU classification R38). With viability values greater than 50%, the chemical is rated as non-irritating to the skin. To assess the relative irritation potential, i.e. skin irritating damage over time, the ET-50 test, also offered by XCellR8, can also be carried out. The method delivers meaningful results within 6–8 weeks and has already been validated by various institutions. The test complies with the UN-GHS requirements, the REACH Regulation, the EU Cosmetics Regulation 1223/2009, and the CLP Regulation 1272/2008. In summary, with the regulatory skin irritation test, XCellR8 offers a comprehensive and easy-to-use approach that enables safe hazard classification of chemicals. Validated and regulatory recognized under OECD Test No. 439.
Regulatory skin irritation test
info@x-cellr8.com
Added on: 02-29-2024
[1] https://www.oecd-ilibrary.org/environment/test-no-439-in-vitro-skin-irritation-reconstructed-human-epidermis-test-method_9789264242845-en[2] https://x-cellr8.com/regulatory-safety-testing/skin-irritation-testing-oecd-tg439/
