PROSPECTIVE VALIDATION STUDY OF RECONSTRUCTED HUMAN TISSUE MODELS FOR EYE IRRITATION TESTING.

ECVAM/Colipa RhT test methods prospective validation study: The objective of the Eye Irritation Validation Study (EIVS) is to formally evaluate the scientific validity of the SkinEthicTM Human Corneal Epithelium (HCE) Short Exposure (SE), Long Exposure (LE) and test strategy and the EpiOcularTM Eye Irritation Test (EIT) through an inter-laboratory ring trial study, to promote international regulatory acceptance for hazard assessment of chemicals. In particular, these test methods/strategy shall be incorporated into a tiered test strategy (so-called Bottom-Up/Top-Down test strategy) as defined in the 2005 ECVAM Expert Meeting (Scott L. et al. 2010. TIV 24, 1-9) as e.g. the initial step in a Bottom-Up approach or the second step in a Top-Down Approach to reliably discriminate chemicals not classified as eye irritant (“non-irritants”) from all classes of eye irritant chemicals as defined by the UN Globally Harmonized System (UN-GHS, No Category vs Category 1/2A/2B) and as implemented in the EU Classification, Labelling, Packaging (EU CLP: No Category vs Category 1/2). The ultimate purpose of the Bottom-Up and Top-Down tiered test strategy will be to replace the traditional in vivo Draize eye irritation test (OECD TG 405). The EIVS will assess the relevance (predictive capacity) and reliability (reproducibility within and between laboratories) of SkinEthicTM HCE SE, LE and test strategy and of EpiOcularTM EIT, by testing a statistically significant number of coded test chemicals supported by complete and quality assured in vivo Draize eye irritation data for comparative evaluation of results.

Bottom-up approach, Chemical selection, EpiOcular Eye Irritation Test (EIT), Eye Irritation Validation Study(EIVS), GHS Category 1, Inter-laboratory ring trial, Top-down approach