Evaluation of an In Vitro Alternative Method for Skin Irritation Using KeraSkin™

다국어 초록 (Multilingual Abstract)

This study evaluated the skin irritation potential of m-phenylenediamine (mPDA) using the reconstructed human epidermis model KeraSkin™ in accordance with OECD Test Guideline (TG) 439 and examined its applicability as an in vitro alternative method in regulatory toxicology. The skin irritation test was conducted with a negative control (D-PBS), a positive control (5% SDS), and a frozen-killed control test, using three tissue replicates per group to ensure reproducibility. The cell viability was determined quantitatively using an MTT assay. The mean cell viability of the mPDA-treated tissues was 11.13%, and the standard deviations of all test groups met the acceptance criteria specified in OECD TG 439, confirming the validity of the test. After incorporating the results of the frozen-killed control test, the final cell viability remained below the 50% threshold. Accordingly, mPDA was classified as a skin irritant (Category 2) under the Globally Harmonized System (GHS). These findings show that KeraSkin™ provides an objective, quantitative, and reproducible assessment of skin irritation and supports its scientific reliability and potential applicability as an in vitro alternative method. Nevertheless, as this study was limited to a single test substance, further validation using diverse chemicals is warranted.