A Validation Study of a New In Vitro Eye Irritation Test using the Reconstructed Human Corneal Epithelial Tissue, LabCyte CORNEA-MODEL24

Eye damage is defined as the production of reversible changes in the eye, following the application of a test chemical to the ocular surface. Chemicals causing such changes are classified as category 2 by the United Nations Globally Harmonized System of Classification and Labeling of Chemicals (UN GHS). In 2015, an eye irritation test (EIT) method developed to identify category 2 chemicals was scientifically validated and approved by the OECD as the test guideline 492 (OECD TG 492). A new EIT using LabCyte CORNEA-MODEL24, a commercially available recombinant human corneal epithelial (RhCE) tissue model developed by Japan Tissue Engineering Co., Ltd. (J-TEC), has been established as a similar method to the OECD TG 492. Here we report the results of a validation study conducted according to the performance standard for the OECD TG 492 to evaluate the accuracy and performance reliability of LabCyte CORNEA-MODEL24 EIT at three independent laboratories. LabCyte CORNEA-MODEL24 EIT was highly predictive and reliable, showing sensitivity of 97%, specificity of 68.9%, and overall accuracy of 83.5%. These results satisfy the acceptance criteria of the performance standard for the OECD TG 492 (90% for sensitivity, 60% for specificity and 75% for accuracy). The reproducibility of results within- and between the three participating laboratories was also within acceptable ranges. Altogether, the results from this validation study confirm that LabCyte CORNEA-MODEL24 EIT is a robust method to identify chemicals with the potential to trigger eye irritation events.