Assessment of the Human Epidermis SkinEthic™ RHE Model for In Vitro Skin Corrosion Testing of Chemicals

Abstract

The SkinEthic™ Reconstructed Human Epidermis (RHE) test method has been adopted within the context of OECD TG 431 for distinguishing corrosive and non-corrosive chemicals as well for identifying UN GHS subcategories 1A and 1B and 1C within the context of Organization for Economic Co-operation and Development Test Guideline 431 (OECD TG 431). The within- and between-laboratory concordance of classifications between runs was found to be ≥92.5% for distinguishing between corrosives and non-corrosives and ≥85% to distinguish between UN GHS subcategory 1A, UN GHS subcategories 1B and 1C, and non-corrosives. In addition to its reproducible values, the SkinEthic™ RHE test method also showed good reproducibility in time. When considering the 80 OECD reference chemicals as recommended in the OECD TG 431, the subcategorization accuracy (i.e. predictive capacity) achieved was 70.8%. Furthermore, due to its high sensitivity and the negligible under-classification, the test method provides high safety standards for skin corrosion testing.