RAW MATERIALS / ESAC opinion in June 24th, 2016
The SkinEthic™ HCE method has been peer reviewed by ESAC (2016-02) and complies with regulatory use.
The implementation of the SkinEthic™ HCE method, as a validated reference method in the OECD test guidelines TG 492 is already considered.
The draft of TG492 on Reconstructed human Cornea-like Epithelium test method for eye hazard potential is currently under review by the states members of OECD with an approval expected by summer 2017.
Our corneal model and corresponding protocols (for liquids and for solids) are designed to comply with regulatory purposes to classify and label chemicals regarding in vitro ocular irritation assessment.
SkinEthicTM HCE - Human Corneal Epithelium
SkinEthicTM HCE model can be used for in vitro eye irritation assessment with one protocol dedicated to liquids and another to solids.
DETAILED ASSAY PROCEDURE
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Multi-laboratory validation of SkinEthicTM HCE test method for testing serious eye damage/eye irritation using liquid chemicals. N. Alépée, V. Leblanc, E. Adriaens, M.-H. Grandidier, D. Lelièvre, M. Meloni, L. Nardelli, C.S. Roper, E. Santirocco, F. Toner, A. Van Rompay, J. Vinall, J. Cotovio. Toxicology In Vitro, 31: 43-53, 2016.
Multi-laboratory validation of SkinEthicTM HCE test method for testing serious eye damage/eye irritation using solid chemicals and overall performance of the test method with regard to solid and liquid chemicals testing. N. Alépée, E. Adriaens, M.-H. Grandidier, M. Meloni, L. Nardelli, C. J. Vinall, F. Toner, C. S. Roper, A. R. Van Rompay, V. Leblanc, J Cotovio. Toxicology In Vitro, 34: 55-70, 2016.