title: A catch-up validation study of an in vitro skin irritation test method using reconstructed human epidermis LabCyte EPI-MODEL24.
abstract: Three validation studies were conducted by the Japanese Society for Alternatives to Animal Experiments in order to assess the performance of a skin irritation assay using reconstructed human epidermis (RhE) LabCyte EPI-MODEL24 (LabCyte EPI-MODEL24 SIT) developed by the Japan Tissue Engineering Co., Ltd. (J-TEC), and the results of these studies were submitted to the Organisation for Economic Co-operation and Development (OECD) for the creation of a Test Guideline (TG). In the summary review report from the OECD, the peer review panel indicated the need to resolve an issue regarding the misclassification of 1-bromohexane. To this end, a rinsing operation intended to remove exposed chemicals was reviewed and the standard operating procedure (SOP) revised by J-TEC. Thereafter, in order to confirm general versatility of the revised SOP, a new validation management team was organized by the Japanese Center for the Validation of Alternative Methods (JaCVAM) to undertake a catch-up validation study that would compare the revised assay with similar in vitro skin irritation assays, per OECD TG No. 439 (2010). The catch-up validation and supplementary studies for LabCyte EPI-MODEL24 SIT using the revised SOPs were conducted at three laboratories. These results showed that the revised SOP of LabCyte EPI-MODEL24 SIT conformed more accurately to the classifications for skin irritation under the United Nations Globally Harmonised System of Classification and Labelling of Chemicals (UN GHS), thereby highlighting the importance of an optimized rinsing operation for the removal of exposed chemicals in obtaining consistent results from in vitro skin irritation assays.
authors.affiliation: Japanese Centre for the Validation of Alternative Methods, National Institute of Health Sciences, 1-18-1, Kamiyoga, Setagaya-ku, Tokyo, 158-8501, Japan.
authors.forename: Hajime
authors.initials: H
authors.lastname: Kojima
authors.forename: Masakazu
authors.initials: M
authors.lastname: Katoh
authors.forename: Shinsuke
authors.initials: S
authors.lastname: Shinoda
authors.forename: Saori
authors.initials: S
authors.lastname: Hagiwara
authors.forename: Tamie
authors.initials: T
authors.lastname: Suzuki
authors.forename: Runa
authors.initials: R
authors.lastname: Izumi
authors.forename: Yoshihiro
authors.initials: Y
authors.lastname: Yamaguchi
authors.forename: Maki
authors.initials: M
authors.lastname: Nakamura
authors.forename: Toshihiko
authors.initials: T
authors.lastname: Kasahawa
authors.forename: Aya
authors.initials: A
authors.lastname: Shibai
mesh_terms: D016475:3T3 Cells; D000826:Animal Testing Alternatives; D000818:Animals; D002460:Cell Line; D049109:Cell Proliferation / Q000187:drug effects; D004817:Epidermis / Q000187:drug effects* / Q000378:metabolism; D006801:Humans; D007509:Irritants / Q000633:toxicity*; D015603:Keratinocytes / Q000187:drug effects / Q000378:metabolism; D051379:Mice; D012871:Skin Diseases / Q000139:chemically induced; D023422:Skin Irritancy Tests / Q000379:methods*
chemical_list: D007509:Irritants
keywords: catch-up; in vitro; reconstructed human epidermis; skin irritation; validation