Assessment of the in vitro skin irritaion by chemicals using the Vitrolife-SkinTM human skin model

Noriyuki Morikawa, Tatsuya Kitagawa and Kenji Tomihata

Research & Development Center, GUNZE Ltd., Kyoto, Japan

AATEX 13(1):11-26, 2008

The European Centre for the Validation of Alternative Methods (ECVAM) is currently supporting formal validation studies of in vitro tests for predicting skin irritancy and corrosivity, including tests employing two human skin models, EPISKINTM and EpiDermTM. When skin models are used to evaluate skin irritancy, it is important that suitable chemical application procedures are used. We evaluated the skin irritancy of 44 chemicals using the postincubation method (10-minutes treatment and 18-hours post-treatment incubation) that we originally developed to predict skin irritancy which is similar to a refined protocol for EPISKINTM proposed in an ECVAM validation study. The sensitivity, specificity, and accuracy obtained with the MTT reduction assay-based prediction model were 77.8%, 76.9%, and 77.3%, respectively while the corresponding values obtained with the interleukin-1α secretion assay-based prediction model were 61.1%, 92.3%, and 79.5%, respectively. Combining these endpoints indicated a clear increase in sensitivity and accuracy to 94.4% and 81.8%, respectively. Vitrolife-SkinTM showed a basic utility for irritancy testing by this method and it is possible to confidently predict skin irritancy, provided that an appropriate chemical application procedure is used.

Key words: human skin model, skin irritancy, Vitrolife-SkinTM, EPISKINTM, ECVAM


(AATEX: Altern. Animal Test. EXperiment.: Alternatives to Animal Testing and EXperimentation)