Refinement of the Episkin® protocol for the assessment of acute skin irritation of chemicals:: follow-up to the ECVAM prevalidation study

The Episkin(R) model took part in the prevalidation study on in vitro tests for acute skin irritation of chemicals, which was carried out during 1999 and 2000. This prevalidation study was co-ordinated and supported by the European Centre for the Validation of Alternative Methods (ECVAM). During Phase 1 and Phase 2 of this study, reproducibility and transferability of the method were verified. Unfortunately, the performance of the method in terms of predictive ability was considered insufficient, due to a low specificity. In order to improve the performance of the Episkin(R) method, the existing protocol was refined. This refinement consisted in reducing the exposure time of epidermis with chemicals. Sensitivity, specificity and accuracy of the new method were 70, 80 and 75%, respectively, thus meeting the acceptance criteria as defined by the Management Team. The Episkin(R) method is now ready to enter a validation study of in vitro tests for acute skin irritation. (C) 2002 Elsevier Science Ltd. All rights reserved.