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PEER Review Package for a Me-Too Validated Skin Irritation Test Method on “The Reconstructed Human Epidermis Model (LabCyte EPI-MODEL 24) for In Vitro Skin Irritation”
A Japanese in vitro test system that uses a reconstructed human epidermis model (LabCyte EPI-MODEL 24) has been validated in accordance with the principles and criteria documented in the OECD Guidance Document on the Validation and International Acceptance of New or Updated Test Methods for Hazard Assessment, No. 34 (OECD, 2005). The test method is a “me-too” submission following the Performance Standards of the draft Test Guideline for “In Vitro Skin Irritation: Reconstructed Human Epidermis (RhE) Test Method”, available on the public website.
The Peer Review is anticipated to be finalised by the end of March 2010.
Document 1: Experiment to find a suitable exposure time for the in vitro skin irritation test method with LabCyte EPI-MODEL24.
Document 2: In vitro irritation test with LabCyte EPI-MODEL24 according to the ECVAM document “Performance Standards for Applying Human Skin Model to in vitro Skin Irritation Testing”. Background data document of LabCyte EPI-MODEL24.
Document 3: JSAAE Skin Irritation Test Validation Study- Skin irritation test protocol using the reconstructed human model: “LabCyte Epi-Model 24”, Ver. 7.2.
Document 4: Katoh, M. et al. skin irritation testing according to ECVAM-validated protocol. J. Toxicol. Sci. 34 (3), 327-334.
Document 5: JSAAE Skin Irritation Test Validation Study- Skin irritation test protocol using the reconstructed human model: “LabCyte Epi-Model 24”, Ver. 6.0.
Document 6: JSAAE Report: Validation of in vitro skin irritation test using LabCyte EPI-MODEL 24 ( 2nd ReportT) July 22, 2009.
Document 7: JSAAE Report: Validation of in vitro skin irritation test using LabCyte EPI-MODEL 24 ( Final ReportT) October 5, 2009.
Document 8: List of back ground documents about LabCyte EPI-MODEL24.
Document 9: Appendix 7 ; QC results of LabCyte EPI-MODEL24 during the validation study.
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