Reconstructed corneal model for regulatory eye irritation testing
Validated Method CompanyXCellR8, Daresbury, United Kingdom
The company's XCellR8 eye irritation test is based on a reconstructed human corneal epithelium (RhCE). The highly differentiated and multilayered model validly recapitulates the biochemical and physiological properties of the corneal barrier and is therefore suitable for sensitive detection of eye-damaging substances. The test enables a simple classification into irritating and non-irritating substances and is suitable for checking individual substances as well as already mixed substances in finished products. The method is approved only for chemicals that do not require classification and labelling for eye irritation or serious eye damage. For the test procedure, the human epithelial cells are grown in special cultivation systems at an air-liquid interface. This allows the test substances to be applied directly to the RhCE. The exposed models are incubated for a certain time (liquids: 30 minutes, solids: 6 hours). Cell viability is then quantitatively determined using MTT conversion. If the viability of the corneal cells is greater than 60%, the test substance can be classified as non-irritating to the eyes. For viability values ≤ 60%, further test measures are required for a more precise hazard classification. In summary, the XCellR8 eye irritation test offers a simple and valid method for identifying corneal-damaging substances in different areas of application. The test complies with the UN-GHS requirements, the REACH Regulation, the EU Cosmetics Regulation 1223/2009, and the CLP Regulation. Validated and regulatory recognized under OECD Test No. 492.
Regulatory eye irritation test
info@x-cellr8.com
Added on: 02-29-2024
[1] https://www.oecd-ilibrary.org/environment/test-no-492-reconstructed-human-cornea-like-epithelium-rhce-test-method-for-identifying-chemicals-not-requiring-classification-and-labelling-for-eye-irritation-or-serious-eye-damage_9789264242548-en[2] https://x-cellr8.com/regulatory-safety-testing/eye-irritation-oecd-tg492/
