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日本における試験法の公定化

JaCVAMが寄与した日本発のOECD TG

入手可能な日本語翻訳版はこちらから

Test Method Accepted TG
In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method, LabCyte EPI-Model24 OECD TG431
In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method, LabCyte EPI-Model24 OECD TG439
Skin Sensitisation: Local Lymph Node Assay: DA OECD TG442A
Skin Sensitisation: Local Lymph Node Assay: BrdU-ELISA or –FCM OECD TG442B
In Chemico Skin Sensitisation Assays addressing the Adverse Outcome Pathway Key Event on Covalent Binding to Proteins, Amino acid Derivative Reactivity Assay (ADRA) OECD TG442C
In Vitro Skin Sensitisation Assays addressing the Adverse Outcome Pathway Key Event on Keratinocyte activation, Epidermal Sensitisation Assay (EpiSensA) OECD TG442D
In Vitro Skin Sensitisation Assays addressing the Key Event on Activation of Dendritic Cells on the Adverse Outcome Pathway for Skin Sensitisation, Human Cell Line Activation Test (h-CLAT) and IL-8 Luc assay OECD TG442E
In Vitro immunotoxicity, IL-2 Luc Assay OECD TG444A
Performance-Based Test Guideline for Stably Transfected Transactivation In Vitro Assays to Detect Estrogen Receptor Agonists and Antagonists, The Stably Transfected TA (STTA) assay using the (h) ERα-HeLa-9903 cell line OECD TG 455
Stably Transfected Human Androgen Receptor Transcriptional Activation Assay for Detection of Androgenic Agonist and Antagonist Activity of Chemicals, AR-Ecoscreen OECD TG458
In Vivo Mammalian Alkaline Comet Assay OECD TG489
Short Time Exposure In Vitro Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage OECD TG491
Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage, LabCyte Cornea-Model24 OECD TG492
Performance-Based Test Guideline for Human Recombinant Estrogen Receptor (hrER) In Vitro Assays to Detect Chemicals with ER Binding Affinity(*) OECD TG493
Vitrigel-Eye Irritancy Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage OECD TG494
Ros (Reactive Oxygen Species) Assay for Photosafety OECD TG495
In Vitro Bhas 42 Cell Transformation Assay (Bhas 42 CTA) OECD GD231

(*)JaCVAMは未関与

JaCVAMが寄与した海外発のOECD TG

Test Method Accepted TG
Skin Sensitisation: Local Lymph Node Assay OECD TG429
In Vitro Membrane Barrier Test Method for Skin Corrosion OECD TG435
Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage OECD TG437
Isolated Chicken Eye Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage OECD TG438
BG1Luc Estrogen Receptor Transactivation Test Method for Identifying Estrogen Receptor Agonists and Antagonists OECD TG457
Fluorescein Leakage Test Method for Identifying Ocular Corrosives and Severe Irritants OECD TG460

JaCVAMが寄与したOECD GD

Test Method Accepted GD
Summary Report of the Peer Review Panel on the Stably Transfected Transcriptional Activation Assay for Detecting Estrogenic Activity of Chemicals, and Agreement of the Working Group of National Coordinators of Test Guidelines Programme on the Follow-up of this Report No. 83
Peer Review Report of the Validation of The Skin Irritation Test Using Labcyte Epi-Model 24 No. 155
Validation Report for the Skin Irritation Test Method using LabCyte EPI-MODEL24 No. 159
Peer Review Report for the Validation of the Stably Transfected Transcriptional Activation Assay for the Detection Androgenic and Anti-Androgenic Activity of Chemicals No. 161
Performance Standards for Stably Transfected Transactivation In Vitro Assays to Detect Estrogen Agonists for TG 455 No. 173
Second Edition Performance Standards For Stably Transfected Transactivation In Vitro Assays To Detect Estrogen Receptor Antagonists No. 174
Report of the JACVAM Initiative International Pre-Validation Studies of the in vivo Rodent Alkaline Comet Assay for the Detection of Genotoxic Carcinogen No. 195
Report of the JACVAM Initiative International Validation Studies of the in vivo Rodent Alkaline Comet Assay for the Detection of Genotoxic Carcinogens No. 196
Peer Review Report of the JACVAM Initiative International Validation Studies of the in vivo Rodent Alkaline Comet Assay for the Detection of Genotoxic Carcinogens No. 197
BHAS 42 Cell Transformation Assay Validation Study Report No. 208
Performance Standards for the Human Recombinant Estrogen Receptor Binding Assay No. 222
Report of the Inter-Laboratory Validation for Stably Transfected Transactivation Assay to Detect Estrogenic and Anti-estrogenic Activity No. 225
Integrated Summary Report: Validation of Two Binding Assays Using Human Recombinant Estrogen Receptor Alpha (hrERa), Annex 1, Annex 2, Annex 3 No. 226
Guidance Document on the In Vitro Bhas 42 Cell Transformation Assay (BHAS 42 CTA) No. 231
Report of the First and Second Validation Studies for AR STTA Assays to Detect Androgenic and Anti-androgenic Activities of Chemicals No. 241
Validation report for the international validation study on the IL-8 Luc assay as a test evaluating the skin sensitizing potential of chemicals conducted by the IL-8 Luc Assay No. 267
Report of the Peer Review Panel for the IL-8 Luciferase (IL-8 Luc) Assay for in vitro skin sensitisation No. 268
Peer Review Report of the Validation of the Labcyte Cornea-Model24 Eye Irritation Test for Inclusion in Test Guideline 492 No. 282
Report of the Validation Study and Report Of the Peer Review of the Validation of the Vitrigel Eye Irritancy Test Method in Test Guideline 494 No. 301
Second Edition, Performance Standards for the assessment of proposed similar or modified in vitro skin sensitisation DPRA and ADRA test methods No. 303
Second Edition, Validation Study Report Of The Amino Acid Derivative Reactivity Assay (ADRA) No. 304
Report of the Peer Review Panel on the Validation of the Amino acid Derivative Reactivity Assay (ADRA) No. 305
Performance Standards for the assessment of proposed similar or modified Vitrigel-Eye Irritancy method for Test Guideline 494 No 313
Guidance Document on the Characterisation, Validation and Reporting of PBK Models for Regulatory Purposes (Glossy - Mono - Annex IV) No. 331
Detailed Review Paper on In Vitro Test Addressing Immunotoxicity With a Focus on Immunosuppression No. 360
Epidermal Sensitisation Assay (EpiSensA) Peer review Report No. 383
Epidermal Sensitisation Assay (EpiSensA) Validation Study Report No. 384

JaCVAMが寄与した日本発のICHガイドライン

Test Method Accepted GD
Ros (Reactive Oxygen Species) Assay for Photosafety ICH S10