Is the RHE model validated for skin irritation of chemicals?
At its 29th meeting, the ECVAM Scientific Advisory Committee (ESAC) unanimously endorsed the following statement “It is concluded that the performance of SkinEthic RHE assay in an external catch up validation study (MTT end point), met the criteria outlined to be considered to have sufficient accuracy and reliability for prediction of R38 skin irritating and no-label (non skin irritating) test substances.”(*) This statement reinforces the SkinEthic leadership in tissue engineering with two validated methods: EpiSkin in 2007 and RHE in 2008. The SkinEthic RHE validated protocol, 42 min exposure, 42 hours incubation time, based on a simple cytotoxic end-point (MTT), showed a good specificity (80%) and sensitivity (90%), a low False positive rate (20%) and False negative rate (10%) with an overall accuracy of 85% during the validation process by three lead and participating laboratories. SkinEthic patented RHE model is a fully differentiated reconstructed epidermis in a chemically defined
