This guideline provides an in vitro skin corrosion test method for cosmetics and other products using a Reconstructed Human Epidermis (RhE) model. It serves as an alternative to animal testing. The method involves applying a test substance to a 3D RhE model, which mimics the human epidermis, and then measuring cell viability using the MTT assay to assess skin corrosion potential. This revised version updates the list of validated test methods, which now include those using the EpiDerm™, SkinEthic™ RHE, epiCS®, and LabCyte EPI-MODEL24 models. The revision was prompted by the discontinuation of the EpiSkin™ model.
Original regulatory document
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