Original paper :AATEX 6(2,3):79-88,2000
With the aim to predict human skin irritation, cytotoxicity tests have recently been introduced on a worldwide basis. Many papers have appeared reporting data with reconstituted human dermal models, skin explants and cultured monolayer cells as alternatives to in vivo skin irritation tests. To answer the question which cytotoxicity tests are the most useful for prediction of human skin irritancy, we compared results of MTT assays using rabbit skin explants (3D-Histoculture : organ model), a reconstituted human dermal model (GunzeTM cultured 3-Dimensional Skin Model : 3-D culture model) , cultured monolayers of human dermal fibroblasts (NB1RGB : monolayer cells) , a Draize rabbit primary skin irritation test (Draize rabbit test) and human patch testing with 12 surfactants.
Comparison of in vivo human data with the in vitro test and Draize rabbit test findings did not demonstrate a good correlation. In particular, monolayer cells showed many false positives. The organ model was the most accurate in term of consistence with human patch results, similar in this respect to the Draize rabbit test.
We therefore consider that this organ model is useful to evaluate the potential for causation of human skin irritation by new surfactants.
Keywords: skin irritation, reconstituted human dermal model, skin explants, in vitro, fibroblasts, and surfactants