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,