Adaptation of the validated SkinEthic™ Reconstructed Human Epidermis (RHE)

At its 25th meeting the ECVAM Scientific Advisory Committee (ESAC) unanimously endorsed that the SkinEthic™ Reconstructed Human Epidermis (RHE) model could be used for distinguishing between corrosive and non-corrosive chemicals within the context of the Organisation Economic for Co-operation and Development (OECD) test guideline, TG 431 (
  • The test method was assessed with 25 representative test substances of different chemical classes.
  • Among the latter, the 12 OECD reference test substances (6 corrosives and 6 non-corrosives) were evaluated
  • and showed to be similarly classified as
  • adapted to 0.5 cm
  • requirements with the 25 test substances.
ESAC 16–17 November 2006). Both test method development and multi-center study were performed using 0.63 cm2 RHE tissue samples. The purpose of the present study was to demonstrate that similar results could be obtained using the validated test method adapted to 0.5 cm2 RHE tissue samples. Test method adaptation only consisted in applying a reduced volume of test substance (40 lL instead of 50 lL for liquids and 20 lL water + 20 mg test substance instead of 25 lL water + 25 mg test substance for solids) and a reduced propan-2-ol extraction volume (1.5 mL instead of 2 mL) during the MTT reduction vivo. More generally, the SkinEthic™ skin corrosion test2 RHE tissue samples fully complies with the OECD performance and reproducibility