JSAAE-JaCVAMワークショップ.pptx
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1
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4 Rs
5 Rs (Russel and Burch 1959) Replacement In itro Reduc/on Refinement
6
7 2003/3/ /9/ /3/ /3/11 EU Testing ban EU Annex V or Annex IX, marketing ban Testing ban EU marketing ban, marketing ban,, Fragrance journal,
8 ICH 2006
9 REACH 9
10
11 11
12 EPAA EU EU (REACH) 3 Rs European Partnership for Alternative Approaches to Animal Testing DGs: Enterprise, Research, Health & Consumer Protection, Environment, Joint Research Centre AISECEFIC COLIPA )ECPA EFPIA( ) EuropaBIO() IFAH()
13 EPAA 13
14 The NTP Roadmap for the 21 st Century n Goal 2 of the Roadmap Develop and validate improved tes2ng methods and, where feasible, ensure that they reduce, refine, or replace the use of animals n From Page 7 Ac2vi2es and assays developed under the NTP Roadmap will be done in coopera2on and consulta2on with ICCVAM to maximize their value to regulatory agencies. 14
15 Toxicity Testing in the 21 st Century: A Vision and a Strategy n From NAS Report: The use of a comprehensive array of in vitro tests to iden2fy relevant biologic perturba2ons with cellular and molecular systems based on human biology could eventually eliminate the need for whole- animal tes2ng and provide a stronger mechanis2cally based approach for environmental decision- making. 15
16 JaCVAM
17 Test Method Evolu/on and Transla/on Process: Concept to Implementa/on Stage Review Risk Assessment Methods Research Development (Pre) ValidaNon ValidaNon Objec+ve IdenNfy need for new, improved and/or alternanve test methods InvesNgate toxic mechanisms; idennfy biomarkers of toxicity Incorporate biomarkers into standardized test method OpNmize transferable test method protocol Determine relevance and reliability Peer Review Acceptance Independent sciennfic evaluanon of validanon status Determine acceptability for regulatory risk assessment ImplementaNon EffecNve use of new methods by regulators and users
18 * yes yes yes yes? yes? yes yes? *from Thomas Hartung, ECVAM, 2003
19 in house
20 ICATM
21 70 R
22 In house in vitro toxicology
23 OECD In vitro toxicology JaCVAM JaCVAM
24 JaCVAM
25 JaCVAM Rs Reduc/on Refinement Replacement
26 Organization of JaCVAM JaCVAM Consultation Advise Advisory Board Regulatory, Research Inst., Industry, Academia and Citizens JaCVAM Steering CommiTee Consulta/on Support Financial support Report NIHS suppor/ng Group Regulatory Authority
27 NIHS Supporting Group JaCVAM Div. of Pathology Div. of Pharmacology Expert Panels outside NCBSR Div. of Toxicology Lab. of Animal Care Div. of Genetics and Mutagenesis Div. of Risk Assessment National Center for Biological Safety Research NCBSR)
28 Framework for Peer Review and Regulatory Acceptance of AlternaNve Methods JaCVAM Statement Regulatory Agencies JaCVAM Steering Committee Support Validation Management Team Specialist of validation, Researcher, biostatistician Validation report Oversight Committee Specialist and developer Establish Establish Background review documents Board Reports Regulatory Acceptance Board Specialist of validation, Researcher, biostatistician Evalua/on Reports Peer Review Panel Specialist of validation, Researcher, biostatistician
29 JaCVAM (
30 OECD
31 Method OECD Test guideline (TG) on animal tes/ng 3Rs accepted since /2 International Acceptance CORROSITEX Skin Corrosivity Test OECD TG 435 (2006) EpiSkin Skin Corrosivity Test OECD TG 431 (2004) EpiDerm Skin Corrosivity Test OECD TG 431 (2004) SkinEthic RHE Skin Corrosivity Test OECD TG 431 (2004) EST-1000 Skin Corrosivity Test OECD TG 431 (2004) Rat TER Skin Corrosivity Test OECD TG 431 (2004) In vitro reconstructed human epidermis test methods OECD WNT March EpiDerm, EPISKIN, SkinEthic RHE 3T3 NRU Phototoxicity Test OECD TG 432 (2004) Bovine Corneal Opacity and Permeability (BCOP) Test OECD TG 437 (2009) Method Isolated Chicken Eye (ICE) Test Method OECD TG 438 (2009)
32 OECD Test guideline (TG) on animal tes/ng 3Rs accepted since 20012/2 Method International Acceptance Updated Murine local lymph node assay (LLNA) for skin OECD TG 429 (updated) sensitization (20% reduction) OECD WNT, March 2010 Reduced LLNA (rllna) OECD TG 429 (updated) OECD WNT, March 2010 Nonradioactive LLNA protocol, LLNA: BrdU-ELISA OECD TG 442B OECD WNT March Nonradioactive LLNA protocol, LLNA:DA OECD TG 442B OECD WNT March Up and Down Procedure (UDP) OECD TG 425 (2001) In vitro micronucleus test Finalisation of draft OECD TG Fixed Dose Procedure (FDP) OECD TG 420 (2001) Acute Toxic Class Method (ATC) OECD TG 423 (2001) Inhalation toxicity - acute toxic class method OECD TG 436 (2009) Stabley transfected human estrogen receptor-α OECD TG 4 55(2009) transcriptional activation assay for detection of estorogenic agonist-activity of chemicals
33 JaCVAMOECD JaCVAM No. 442a: Skin Sensitisation: Local Lymph Node Assay Non-RI method LLNA DA) No. 442b: Skin Sensitisation: Local Lymph Node Assay Non-RI methodllna BrdU-ELISA) No.455:The Stable Trasfected Human Estrogen Receptor-alpha Transcriptional Activation Assay for Detecion of Estrogenic Agonist- Activity of Chemicals JaCVAM No. 429: Updated Skin Sensitisation: Local Lymph Node Assay No. 437 Bovine Corneal Opacity and permeability Test Methods for Identifying Ocular Corrosives and Severe Irritants No. 438 Isolated Chicken Eye Test Methods for Identifying Ocular Corrosives and Severe Irritants No. 439 In vitro skin Irritation assay 2010
34 JaCVAM u The Bovine Corneal Opacity and Permeability (BCOP) Test Method for IdenNfying Ocular Corrosives and Severe Irritants u The Isolated Chicken Eye (ICE) for IdenNfying Ocular Corrosives and Severe Irritants u Skin sensinzanon assay, LLNA DA u Skin sensinzanon assay, LLNA BrdU- ELISA u In vitro skin irritanon tesnng: EPISKIN u In vitro skin corrosion tesnng: Vitrolife- Skin, EpiDerm 34
35
36 JaCVAM peer review SIRC assay for eye irrita/on tes/ng MATREX assay for eye irrita/on tes/ng LabCyte assay for skin irrita/on tes/ng (with OECD) Lumi- cell assay for endocrine disruptor screening (with ICCVAM) SHE & 3T3 assays for cell transforma/on assay (with ECVAM) In vitro pyrogenicity tes/ng In vitro cytotoxicity test methods for es/ma/ng star/ng doses for acute oral systemic toxicity tests 36
37 JaCVAM OECD in vivo 4 in vitro 7 1 OECD OECD Bhas STTA-antagonist CCi William Stokes 3 NICEATM/ NIEHS OECD OECD STE ROS ICH h-clat 2011 David Basketter UK 4 2 EU
38 Method Tiered testing strategy to predict phototoxicity (3T3 NRU PT and reconstructed human epidermis models) Four cell function-based in vitro assays - Cytosensor Microphysiometer (CM) - Fluorescein leakage (FL) Human reconstructed tissue models - EpiOcular - SkinEthic HCE Nonradioactive LLNA protocol (LLNA: BrdU-Flow Cytometry In vitro skin sensitization assays (h-clat; DPRA; MUSST) In vitro hepatic biotransformation enzyme induction MELN estrogen receptor transcriptional activation assay: agonist and antagonist protocols Genotoxicity assays in 3D skin models In vitro hepatic biotansformation CYP induction Hepa RG and cryopreserved human hepatocytes ECVAM ECVAM; NICEATM-ICCVAM ECVAM; JaCVAM, NICEATM- ICCVAM, and Health Canada VMT liaisons NICEATM-ICCVAM ECVAM; JaCVAM, NICEATM- ICCVAM VMT liaison members ECVAM ECVAM/ICCVAM/JaCVAM ECVAM ECVAM/ICCVAM/JaCVAM
39 KoCVAM BraCVAM
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41 Interna/onal Coopera/on on Alterna/ve Test Methods (ICATM) 41
42 USA Japan NAS/ EPA Vision and strategy in the21 st Century Revised Act on Welfare and Management of Animals Revised Act on the Evalua/on of Chemical Substances and Regula/on of Their Manufacture EU REACH & Cosme/c Direc/ve UNlizaNon of AlternaNve to Animal TesNng ICATM JaCVAM ICH OECD ICCR 42
43 OECD ICATM OECD ICH
44 ICATM
45 JaCVAM JaCVAM ICATM 45
46 46
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千葉科学大2011.pptx
2011 7 1. 2. 3. 4. 5. Rs (Russel and Burch 1959) Replacement In Vitro Reduc@on Refinement 2003/3/11 2004/9/11 2009/3/11 2013/3/11 EU Testing ban EU Annex V or Annex IX, marketing ban Testing ban EU marketing
日本での皮膚感作性代替法 開発状況について
平成 25 年 8 月 30 日 大阪日本化粧品技術者会大阪支部勉強会 動物実験代替法の国際動向 小島肇 JaCVAM, NIHS 1 内容 1. 動物実験を巡る国内外の動向 動物実験の 3Rs ICCR と ICATM への関与 厚生労働省の対応 2.OECD TG の動向と JaCVAM 3. 眼刺激性試験代替法の最新情報 4. 皮膚感作性試験代替法の最新情報 5.AOP と試験法 2 動物実験を巡る国内外の動向
化粧品の安全性を考える
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CAS NC(CH 2 ) 4 CN 1,4- C 6 H 8 N c.c d = Pa
1 200117 21512 CAS 111693 110 NC(CH 2 ) 4 CN 1,4- C 6 H 8 N 2 108.14 1 99 2-1. 2 1 295 159 c.c. 550 3 1.7-4.9 20 d 0.965 4 3.73 = 1 0.3 Pa 0.002 mmhg20 2 log Pow-0.32 m/z 41, 1.0 68 0.54 54 0.43 4 Koc9-16
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化粧品の安全性を考える
2013 年 10 月 24 日日皮協会員研修会 動物実験を用いないで医薬部外品の承認申請を取ることは可能か? 国立医薬品食品衛生研究所 小島肇 1 目次 安全と安心 化粧品 医薬部外品の規制 動物実験の 3Rs 代替法利用の現状 動物を用いない代替法のみで可能となる条件 2 安全と安心 安全 ( あんぜん ) は 危険がないこと 被害 ( 有形 無形を問わず ) を受ける可能性がないことである 安心
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98-02.PDF
1 982 2207 CAS 67630 2- H 3 C H 3 C CH OH C 3 H 8 O 60.10 1 99.9 % n- 1. 2-88.5 3 82.5 3 11.7c.c. 455 4 212 d 20 4 0.78505 3 2.1 = 1 4 4.4 kpa 33 mmhg20 4 log Pow0.05 0.07 5 m/z45, 1.0 43 0.19 27 0.17
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1 皮膚感作性試験代替法としての LLNA:DA を 化粧品 医薬部外品の安全性評価に活用するためのガイダンス 医薬部外品の製造販売承認申請及び化粧品基準改正要請では 化学物質の感作性を評価するために 従来から モルモットを用いた皮膚感作性試験が最も一般的に用いられてきている OECDテストガイドラ
事務連絡 平成 25 年 5 月 30 日 各都道府県衛生主管部 ( 局 ) 薬務主管課御中 厚生労働省医薬食品局審査管理課 皮膚感作性試験代替法 (LLNA:DA LLNA:BrdU-ELISA) を化粧品 医薬部外品の 安全性評価に活用するためのガイダンスについて 今般 皮膚感作性試験代替法 (LLNA:DA LLNA:BrdU-ELISA) について その利用促進を図るため 平成 24 年度レギュラトリーサイエンス総合研究事業
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1 9924 2260 CAS 107186 H 2 C CH CH 2 OH 2- -1- C 3 H 6 O 58.08 1 99 1. 2, 3 3, 4, 5-129 96-97 2 21c.c. 24o.c. 2 6, 7 378 6, 7 2.5-18 d 20 4 0.8540 2, 5 2.00 = 1 2.7 kpa 20 mmhg204.3 kpa 32 mmhg30 4 log
ISSN ISBN C3033 The Institute for Economic Studies Seijo University , Seijo, Setagaya Tokyo , Japan
ISSN 2187 4182 ISBN 978 4 907635 09 1 C3033 The Institute for Economic Studies Seijo University 6 1 20, Seijo, Setagaya Tokyo 157-8511, Japan ISSN 2187 4182 ISBN 978 4 907635 09 1 C3033 The Institute
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