Assessment of the human epidermal model LabCyte EPI-MODEL for In vitro skin corrosion testing according to the OECD test guideline 431.
A new OECD test guideline 431 (TG431) for in vitro skin corrosion tests using human reconstructed skin models was adopted by OECD in 2004. TG431 defines the criteria for the general function and performance of applicable skin models. In order to confirm that the new reconstructed human epidermal model, LabCyte EPI-MODEL is applicable for the skin corrosion test according to TG431, the predictability and repeatability of the model for the skin corrosion test was evaluated. The test was performed according to the test protocol described in TG431. Based on the knowledge that LabCyte EPI-MODEL is an epidermal model as well as EpiDerm, we decided to adopt the the Epiderm prediction model of skin corrosion for the LabCyte EPI-MODEL, using twenty test chemicals (10 corrosive chemicals and 10 non-corrosive chemicals) in the 1(st) stage. The prediction model results showed that the distinction of non-corrosion to corrosion corresponded perfectly. Therefore, it was judged that the prediction model of EpiDerm could be applied to the LabCyte EPI-MODEL. In the 2(nd) stage, the repeatability of this test protocol with the LabCyte EPI-MODEL was examined using twelve chemicals (6 corrosive chemicals and 6 non-corrosive chemicals) that are described in TG431, and these results recognized a high repeatability and accurate predictability. It was concluded that LabCyte EPI-MODEL is applicable for the skin corrosive test protocol according to TG431.
Katoh
Masakazu
M
Japan Tissue Engineering Co., Ltd., R&D Department, Miyakitadori, Gamagori, Aichi, Japan. masakazu_katoh@jpte.co.jp
Hamajima
Fumiyasu
F
Ogasawara
Takahiro
T
Hata
Ken-Ichiro
K
D000826:Animal Testing Alternatives / Q000379:methods*; D002424:Caustics / Q000633:toxicity*; D002470:Cell Survival / Q000187:drug effects; D002478:Cells, Cultured; D000078404:Epidermal Cells; D017408:Guidelines as Topic; D006801:Humans; D015603:Keratinocytes / Q000187:drug effects*; D008954:Models, Biological; D015203:Reproducibility of Results; D023422:Skin Irritancy Tests / Q000379:methods*
D002424:Caustics