The EURL ECVAM - Cosmetics Europe prospective validation study of Reconstructed human Cornea-like Epithelium (RhCE)-based test methods for identifying chemicals not requiring classification and labelling for serious eye damage/eye irritation: Validation Study Report
A prospective validation study of two Reconstructed human Tissue-based in vitro test methods (EpiOcular™ EIT and SkinEthic™ HCE) was conducted by EURL ECVAM and Cosmetics Europe to evaluate their usefulness to identify chemicals as either not classified for serious eye damage/eye irritation (No Category) or as classified (Category 1/Category 2) within UN GHS, in the framework of a Bottom-Up/Top-Down test strategy [1]. The study assessed the validity of two EpiOcular™ EIT protocols for liquids and solids, two independent SkinEthic™ HCE protocols based on short-time (SE) and long-time (LE) exposures and a test strategy combining SE and LE. The results and conclusions of this study will be presented.
Briefly, over 100 chemicals were tested and both methods showed high reproducibility (>90%). The EpiOcular™ EIT liquids protocol met all the study acceptance criteria for predictive capacity [2], but not all of these criteria were met by the solids protocol nor by any of the SkinEthic™ HCE protocols/strategy. This led to optimisation of the EpiOcular™ EIT solids protocol and further validation being conducted. With final sensitivity of 96%, specificity of 63% and accuracy of 80%, the EpiOcular™ EIT met all the study acceptance criteria and is considered valid for the proposed study objective.
VIEGAS BARROSO Joao Filipe;
ALÉPÉE Nathalie;
COLE Thomas;
ESKES Chantra;
FREEMAN Stuart;
LISKA Roman;
MCNAMEE Pauline;
PFANNENBECKER Uwe;
REUS Astrid;
RUBINGH Carina;
SCHAEFFER Michael Wilhelm;
ZUANG Valerie;
2016-01-26
Publications Office of the European Union
JRC100280
978-92-79-62208-3,
1831-9424,
EUR 28125 EN,
OP LA-NA-28125-EN-N,
https://publications.jrc.ec.europa.eu/repository/handle/JRC100280,
10.2787/41680,
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