An in vitro skin irritation test using the skinethic™ reconstructed human epidermal (RHE) model

Abstract

The SkinEthic™ Reconstructed Human Epidermal (RHE) skin irritation method is an internationally accepted OECD test method used to detect the skin irritation properties of chemicals (OECD TG 439). The SkinEthic™ RHE skin irritation test method has been shown to be robust and transferable. The reproducibility and predictivity of the SkinEthic™ RHE assay have been evaluated in validation studies organized with three laboratories, and with a set of 20 chemicals through a systematic and in vivo Draize comparative evaluation for safety assessment, delivering results that matched very well with corresponding in vivo data, showing 69% specificity, 100% sensitivity and 80% accuracy under GHS classification system. It could be regarded as a primary source of information concerning the skin irritation properties of the tested chemical and be used in combination with a battery of assays, such as the SkinEthic™ RHE skin corrosion method, in any initiative aimed at developing integrated testing strategies for full evaluation of local skin effects.