A catch-up validation study of an in vitro skin irritation test method using reconstructed human epidermis LabCyte EPI-MODEL24.

摘要: Three validation studies were conducted by the Japanese Society for Alternatives to Animal Experiments in order assess performance of a skin irritation assay using reconstructed human epidermis (RhE) LabCyte EPI-MODEL24 (LabCyte SIT) developed Japan Tissue Engineering Co., Ltd. (J-TEC), and results these submitted Organisation Economic Co-operation Development (OECD) creation Test Guideline (TG). In summary review report from OECD, peer panel indicated need resolve an issue regarding misclassification 1-bromohexane. To this end, rinsing operation intended remove exposed chemicals was reviewed standard operating procedure (SOP) revised J-TEC. Thereafter, confirm general versatility SOP, new management team organized Center Validation Alternative Methods (JaCVAM) undertake catch-up study that would compare with similar vitro assays, per OECD TG No. 439 (2010). The supplementary SIT SOPs at three laboratories. These showed SOP conformed more accurately classifications under United Nations Globally Harmonised System Classification Labelling Chemicals (UN GHS), thereby highlighting importance optimized removal obtaining consistent assays. Copyright © 2013 John Wiley & Sons,