Skin irritation hazard of chemicals assessed by the episkin™ in vitro test method

Abstract

The EpiSkin™ skin irritation method is an internationally accepted test method used to detect the skin irritation properties of chemicals. The EpiSkin™ skin irritation test method has been shown to be robust and transferable. The reproducibility and predictivity of the EpiSkin™ assay have been evaluated in validation studies organized with three laboratories, and with a large set of 122 chemicals through a systematic in vivo Draize comparative evaluation for safety assessment, that delivered results that matched very well with corresponding in vivo data showing 75% for specificity (n = 65), 94% for sensitivity (n = 57) and 84% for accuracy (n = 122). 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 EpiSkin™ skin corrosion method, in any initiative aimed at developing integrated testing strategies for full evaluation of local skin effects.