Development of in vitro skin corrosion test using Keraskin™-VM

抄録

Skin corrosion and irritation are critical toxicological concerns associated with chemical exposure. The Organization for Economic Co-operation and Development (OECD) has approved the use of the Reconstructed Human Epidermis (RHE) model, Keraskin™-VM, for me-too in vitro skin irritation test. Here, we explored the applicability of Keraskin™-VM for skin corrosion test, expanding its validated use beyond irritation test. Thirty reference chemicals, including Category 1A, 1B/1C, and non-corrosive substances as described in OECD TG 431 performance standards, were tested. Test chemicals were applied for 3 or 60 min, and cell viability was measured using MTT assay. Classification criteria were based on viability thresholds, wherein <15% at 3 min indicates Category 1A corrosives, ≥15% at 3 min and <15% at 60 min, Category 1B/1C, and otherwise, non-corrosives. The Keraskin™-VM skin corrosion test correctly classified 23 out of 30 chemicals, demonstrating excellent predictive capacity and the potential of Keraskin™-VM as a reliable in vitro model for skin corrosion test. Further full validation test is underway for the approval of the Keraskin™-VM skin corrosion test for OECD TG 431.