IL-2-Luc白细胞毒性试验（IL-2-Luc-LTT）体外免疫毒性验证的同行评审报告

Series on Testing and Assessment No. 392 Peer-Review Report of the Validation of theIL-2 Luc Leukocyte Toxicity Test (IL-2 LucLTT) Assay on In Vitro Immunotoxicity Please cite this publication as: OECD (2024),Peer-Review Report of the Validation of the IL-2 Luc Leukocyte Toxicity Test (IL-2 Luc LTT) Assay on In VitroImmunotoxicity, OECD Series on Testing and Assessment, No. 392 (if applicable), 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 originalwork and the translation, 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 andarguments employed in 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 thethird party and for any claims of infringement.You must not use the OECD logo, visual identity or cover image without express permission or suggest the OECD endorses your use of the work.Any dispute arising under this licence shall be settled by arbitration in accordance with the Permanent Court of Arbitration (PCA) Arbitration Rules 2012. The seatof arbitration shall be Paris (France). The number of arbitrators shall be one. About the OECD The Organisation for Economic Co-operation and Development (OECD) is an intergovernmentalorganisation in which representatives of 38 countries in North and South America, Europe andthe Asia and Pacific region, as well as the European Union, meet to co-ordinate and harmonisepolicies, discuss issues of mutual concern, and work together to respond to internationalproblems. Most of the OECD’s work is carried out by more than 200 specialised committees andworkinggroups composed of member country delegates. Observers from several Partnercountries and from interested international organisations attend many of the OECD’s workshopsand other meetings. Committees and working groups are served by the OECD Secretariat,located in Paris, France, which is organised into directorates and divisions. The Environment, Health and Safety Division publishes free-of-charge documents in twelvedifferent series:Testing and Assessment;Good Laboratory Practice and ComplianceMonitoring;Pesticides;Biocides;Risk Management;Harmonisation of RegulatoryOversight in Biotechnology;Safety of Novel Foods and Feeds; Chemical Accidents;PollutantRelease and Transfer Registers;Emission Scenario Documents;Safety ofManufactured Nanomaterials;andAdverse Outcome Pathways.More information about theEnvironment, Health and Safety Programme and EHS publications is available on the OECD’sWorld 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. 4| IL-2 Luc LTT assay validation -Report of the Peer Review Panel A JaCVAM coordinated study program addressing the validation status of the IL-2 Luc LTT forprospective identification of immunotoxic chemicals. Report completed by the Peer Review Panel on May 2, 2023. Foreword This document contains the report of the peer-review organized by Japan for the validation of theIL-2 Luc LTT assay on in vitro immunotoxicity, a project on the work plan of the Test GuidelinesProgramme. When the project proposal was discussed in 2022, the WNT recommended to take a step-wiseapproach and consult the WNT after the validation report and peer-review reports are reviewedby the Expert Group to decide on the pertinence of developing a Test Guideline. The validation report and the peer-review report were circulated in September and again inDe