评估拟议的类似或改进的体外表皮致敏试验（EpiSensA）测试方法的性能标准

Series on Testing and AssessmentNo. 396 Performance Standards for the Assessmentof Proposed Similar or Modified In VitroEpidermal Sensitisation Assay (EpiSensA)Test Methods 2024 Please cite this publication as: OECD (2024),Performance Standards for the Assessment of Proposed Similar or Modified In Vitro Epidermal SensitisationAssay (EpiSensA) Test Methods, OECD Series on Testing and Assessment, No. 396, OECD Publishing, Paris. © OECD 2024 Attribution 4.0 International (CC BY 4.0) This work is made available under the Creative Commons Attribution 4.0 International licence. By using this work, you accept to be bound by the terms of this licence(https://creativecommons.org/licenses/by/4.0/). Attribution– you must cite the work. Translations– you must cite the original work, identify changes to the original and add the following text:In the event of any discrepancy between the original work and thetranslation, only the text of original work should be considered valid. Adaptations– you must cite the original work and add the following text:This is an adaptation of an original work by the OECD. The opinions expressed and arguments employedin this adaptation should not be reported as representing the official views of the OECD or of its Member countries. Third-party material– the licence does not apply to third-party material in the work. If using such material, you are responsible for obtaining permission from the third party andfor any claims of infringement. Any dispute arising under this licence shall be settled by arbitration in accordance with the Permanent Court of Arbitration (PCA) Arbitration Rules 2012. The seat of arbitrationshall be Paris (France). The number of arbitrators shall be one. About the OECD TheOrganisation for Economic Co-operation and Development(OECD)is an intergovernmentalorganisation in which representatives of 38 countries in North and South America, Europe and the Asiaand Pacific region, as well as the European Union, meet to co-ordinate and harmonise policies, discussissues of mutual concern, and work together to respond to international problems. Most of the OECD’swork is carried out by more than 200 specialised committees and working groups composed of membercountrydelegates.Observers from several Partner countries and from interested internationalorganisations attend many of the OECD’s workshops and other meetings. Committees and working groupsare served by the OECD Secretariat, located in Paris, France, which is organised into directorates anddivisions. The Environment, Health and Safety Division publishes free-of-charge documents in twelve differentseries:Testing and Assessment;Good Laboratory Practice and Compliance Monitoring;Pesticides;Biocides;Risk Management;Harmonisation of Regulatory Oversight in Biotechnology;Safety ofNovel Foods and Feeds; Chemical Accidents; Pollutant Release and Transfer Registers; EmissionScenario Documents; Safety of Manufactured Nanomaterials;andAdverse Outcome Pathways.More information about the Environment, Health and Safety Programme and EHS publications is availableon the OECD’s World Wide Web site (https://www.oecd.org/en/topics/chemical-safety-and-biosafety.html). This publication was developed in the IOMC context. The contents do not necessarilyreflect the views or stated policies of individual IOMC Participating Organizations. The Inter-Organisation Programme for the Sound Management of Chemicals (IOMC)was established in 1995 following recommendations made by the 1992 UN Conferenceon Environment and Development to strengthen co-operation and increase internationalco-ordination in the field of chemical safety. The Participating Organisations are FAO,ILO,UNDP,UNEP,UNIDO,UNITAR,WHO,World Bank,Basel,Rotterdam andStockholm Conventions and OECD. The purpose of the IOMC is to promote co-ordinationof the policies and activities pursued by the Participating Organisations, jointly orseparately, to achieve the sound management of chemicals in relation to human healthand the environment. PERFORMANCE STANDARDS FOR THE ASSESSMENT OFPROPOSED SIMILAR OR MODIFIED IN VITRO EPIDERMALSENSITISATION ASSAY (EpiSensA) TEST METHODS(Intended for the developers of new ormodified similar test methods) Foreword This document contains the Performance Standards (PS) for the assessment of proposed in vitroassays, similar to the in vitro Epidermal Sensitisation Assay (EpiSensA), or modified. The EpiSensAis an in vitro method for identifying the skin sensitisation potential of chemicals. It is included asAppendix IC of Test Guideline 442D, which addresses Key Event 2 i.e. keratinocytes activation, onthe Adverse Outcome Pathway for skin sensitisation. The PS were developed by Japan in parallel tothe development of the EpiSensA. In 2023, the WNT discussed how to deal with the limited availability outside Japan of the Labcyte 3Dskin model used in the EpiSensA. The development of PS was agreed as the solution to overcomethis problem, in order to facilitate