A Tiered Approach for Eye Irritation Evaluation Combined the Short Time Exposure (STE) Test and the Bovine Corneal Opacity and Permeability (BCOP) Assay
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This study aimed to establish a practical indicator for assessing moderate eye irritation by applying a tiered approach that incorporates the Short Time Exposure (STE) test, and the IVIS (in vitro irritancy score) and histopathological evaluations conducted through the Bovine Corneal Opacity and Permeability (BCOP) assay which recognized as alternative eye irritation methods. Seven test substances described in OECD Test Guideline 491 were employed in the experiments. Through this work, a good tiered evaluation scheme was constructed. To verify the reliability of this tiered scheme, all stages of testing were carried out for non-irritant substances, and consistent negative responses were observed across the STE test, BCOP assay, and histopathological examination. Consequently, the tiered approach demonstrated 100% accuracy, specificity, and sensitivity, indicating its strong predictive capacity for estimating the eye-irritation potential of test materials. Overall, the findings provide a useful indicator for evaluating moderate irritation within alternative eye-irritation testing and support the establishment of an effective IATA-based strategy. These results are expected to contribute meaningfully to future alternative-test research efforts in Korea.
Abstract
This study aimed to establish a practical indicator for assessing moderate eye irritation by applying a tiered approach that incorporates the Short Time Exposure (STE) test, and the IVIS (in vitro irritancy score) and histopathological evaluations conducted through the Bovine Corneal Opacity and Permeability (BCOP) assay which recognized as alternative eye irritation methods. Seven test substances described in OECD Test Guideline 491 were employed in the experiments. Through this work, a good tiered evaluation scheme was constructed. To verify the reliability of this tiered scheme, all stages of testing were carried out for non-irritant substances, and consistent negative responses were observed across the STE test, BCOP assay, and histopathological examination. Consequently, the tiered approach demonstrated 100% accuracy, specificity, and sensitivity, indicating its strong predictive capacity for estimating the eye-irritation potential of test materials. Overall, the findings provide a useful indicator for evaluating moderate irritation within alternative eye-irritation testing and support the establishment of an effective IATA-based strategy. These results are expected to contribute meaningfully to future alternative-test research efforts in Korea.