EURL ECVAM – Cosmetics Europe Prospective validation study of EpiOcular™ EIT & SkinEthic™ HCE

• TR Number: 769
• Keywords: Validation study, EpiOcular Eye Irritation Test (OCL-EIT), Optimized protocol, Intra-laboratory reproducibility, Inter-laboratory reproducibility, Predictive capacity, GHS classification, Animal replacement, Solids protocol, Cosmetics Europe/ECVAM validation, Eye Irritation Validation Study.

A prospective validation study of two Reconstructed human Tissuebased 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 (Category1/Category 2) within UN GHS, in the framework of a Bottom-Up/Top-Down test strategy (Scott et al., 2010). 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 (Adriaens et al., 2014), 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. References: Adriaens, E., Barroso, J., Eskes, C. et al. (2014). Arch Toxicol 88, 701-723. Scott, L., Eskes, C., Hoffman, S. et al. (2010). Toxicol In Vitro 24, 1-9.