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JaCVAM Statements

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Classification Test method Asign BThe Regulatory Acceptance Board Report CEditorial Report ZOthers
01Corrosivity test 01Vitrolife-skinTM

Reconstructed human tissue (developed in Japan; Vitrolife-Skin) cytotoxicity assay

 
01_01_Aen1.pdf 01_01_Ben1.pdf 01_01_Cen1.pdf
OECD01_01_Z2.pdf
02EpiSkin™、EpiDerm™、SkinEthics™、epiCS®)

Reconstructed human tissue (developed in Japan; Vitrolife-Skin) cytotoxicity assay

 
01_02_Aen1.pdf     ・OECD TG43101_02_Z1.pdf
・PERFORMANCE STANDARDS FOR THE ASSESSMENT OF PROPOSED SIMILAR OR
MODIFIED IN VITRO RECONSTRUCTED HUMAN EPIDERMIS (RHE) TEST METHODS FOR SKIN
CORROSION TESTING AS DESCRIBED IN TG 431
01_02_Z2.pdf
03Transcutaneous Electricial Resistance

Reconstructed human tissue (developed in Japan; Vitrolife-Skin) cytotoxicity assay

 
     

04In vitro membrane barrier test method for skin corrosionM

Reconstructed human tissue (developed in Japan; Vitrolife-Skin) cytotoxicity assay

 
     

05LabCyte EPI

Reconstructed human tissue (developed in Japan; Vitrolife-Skin) cytotoxicity assay

 
     

02Phototoxicity 013T3-NRU

In Vitro 3T3 NRU (neutral red uptake)Phototoxicity Test

 
  02_01_Ben1.pdf    
02Yeast-RBC assay

Combination of yeast growth and hemolysis testing as alternative phototoxicity test

 
       
03ROS

ROS (reactive oxygen species) assay

 
02_03_Aen1.pdf   02_03_C1.pdf Validation report02_03_D1.pdf
02_03_D2.pdf
02_03_D3.pdf
protocol 【New】
02_03_E3.pdf
【Archive】
02_03_E1.pdf
02_03_E2.pdf
03Skin sensitization test 01LLNA

Local lymph node assay (LLNA)

 
       
02rLLNA

Reduced LLNA (rLLNA)

03_02_Aen1.pdf 03_02_Ben1.pdf 03_02_C2.pdf ICCVAM TEST METHOD EVALUATION REPORT03_02_Z1.pdf
03LLNA:DA

LLNA:DA (LLNA modified by Daicel based on ATP content)

03_03A_Aen1.pdf 03_03A_Ben1.pdf   OECD 42903_03A_Z3.pdf
  03_03B_Aen1.pdf 03_03B_Ben1.pdf   OECD 442A 03_03B_Z1.pdf
ICCVAM Test Method Evaluation Report 03_03B_Z2.pdf
04LLNA:BrdU-ELISA

LLNA:BrdU-ELISA

03_04A_Aen1.pdf 03_04A_Ben1.pdf    
  03_04B_Aen1.pdf 03_04B_Ben1.pdf   OECD 442B 03_04B_Z1.pdf
ICCVAM Test Method Evaluation Report 03_04B_Z2.pdf
05h-CLAT

Human cell line activation test (h-CLAT) for alternative skin sensitization assay

 
03_05_Aen1.pdf     OECD 442E 03_05_Z1.pdf
EURL ECVAM Recommendation on the human Cell Line Activation Test (h-CLAT) for skin sensitisation testing 03_05_Z2.pdf
06DPRA

Direct peptide reactivity assay (DPRA) for alternative skin sensitization assay

 
03_06_Aen1.pdf     OECD TG442C 03_06_Z1.pdf
EURL ECVAM Recommendation on the Direct Peptide Reactivity Assay (DPRA) for Skin Sensitisation Testing 03_06_Z2.pdf
07KeratinoSense

KeratinoSense assay for alternative skin sensitization assay

 
03_07_Aen1.pdf     OECD TG422D
03_07_Z1.pdf
JRC SCIENTIFIC AND POLICY REPORTS, EURL ECVAM Recommendation on the KeratinoSensTM assay for skin sensitisation testing
03_07_Z2.pdf
08IL-8 Luc assay

IL-8 Luc assay for alternative skin sensitization assay

 
    03_08_C1.pdf 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 03_08_D1.pdf IL-8 Luc assay protocol ver. 023E 03_08_E1.pdf
09U-SENSE

IL-8 Luc assay for alternative skin sensitization assay

 
       
10ADRA

IL-8 Luc assay for alternative skin sensitization assay

 
       
Classification Test method Asign BThe Regulatory Acceptance Board Report CEditorial Report ZOthers
04Skin irritation 01LabCyte EPI-MODEL24

Alternative skin irritation test method using Reconstructed human tissue (developed in Japan; LabCyte EPI-MODEL)

04_01_Aen1.pdf   04_01_C2.pdf OECD TG43904_01_Z1.pdf
02Episkin, EpiDerm and SkinEthic

alternative skin irritation test method using Reconstructed human tissue (Episkin, EpiDerm and SkinEthic)

04_02A_Aen1.pdf 04_02A_Ben1.pdf   STATEMENT ON THE VALIDITY OF IN-VITRO TESTS FOR SKIN IRRITATION 04_02A_Z2.pdf
  04_02B_Aen1.pdf 04_02B_Ben1.pdf   STATEMENT ON THE SCIENTIFIC VALIDITY OF IN-VITRO TESTS FOR SKIN IRRITATION TESTING 04_02B_Z2.pdf
STATEMENT1 ON THE PERFORMANCE UNDER UN GHS OF THREE IN-VITRO ASSAYS FOR SKIN IRRITATION TESTING AND THE ADAPTATION OF THE REFERENCE CHEMICALS AND DEFINED ACCURACY VALUES OF THE ECVAM SKIN IRRITATION PERFORMANCE STANDARDS 04_02B_Z4.pdf
ESAC STATEMENT ON THE PERFOMANCE STANDARS(PS) FOR IN VITRO SKIN IRRITATION TESTING USING RECONSTRUCTED HUMAN EPIDERMIS ※ 04_02B_Z6.pdf
STATEMENT ON THE VALIDITY OF IN-VITRO TESTS FOR SKIN IRRITATION※ 04_02B_Z7.pdf
05Skin absorption test 01In vitro Skin absorption test

In vitro Skin absorption test

 
05_01_Aen1.pdf     OECD 42805_01_Z1.pdf
SCIENTIFIC COMMITTEE ON CONSUMER PRODUCTS05_01_Z2.pdf
COLIPA GUIDELINE05_01_Z3.pdf
06Ocular irritation test 01BCOP

Bovine corneal opacity and permeability (BCOP) test method

06_01A_Aen1.pdf 06_01A_Ben1.pdf 06_01A_Cen1.pdf ICCAM TEST METHOD EVALUATION REPORT06_01A_Z1.pdf
  06_01B_Aen1.pdf     OECD 437B 06_01B_Z1.pdf
STREAMLINED SUMMARY DOCUMENT SUPPORTING OECD GUIDELINE 437 ON THE BOVINE CORNEAL OPACITY AND PERMEABILITY FOR EYE IRRITATION/CORROSION 06_01B_Z2.pdf
02 ICE

Isolated chicken eye (ICE) test method

06_02_Aen1.pdf 06_02_Ben1.pdf   ICCAM TEST METHOD EVALUATION REPORT06_02_Z1.pdf
03FL

Fluorescein Leakage Test Method

06_03_Aen1.pdf 06_03_Ben1.pdf   STATEMENT ON THE SCIENTIFIC VALIDITY OF CYTOTOXICITY/CELLFUNCTION BASED IN VITRO ASSAYS FOR EYE IRRITATION TESTING06_03_Z1.pdf
OECD 46006_03_Z2.pdf
Fluorescein Leakage Assay Background Review Document As An Alternative Method for Eye Irritation Testing06_03_Z3.pdf
04CM

Cytosensor microphysiometer test

 
       
05STE

Short Time Exposure In Vitro Test Method

 
06_05_Aen1.pdf     OECD GUIDELINE FOR THE TESTING OF CHEMICALS 49106_05_Z1.pdf
Short Time Exposure (STE) Test Method Summary Review Document06_05_Z2.pdf
06SIRC-CVS

Cytyotoxicity test: the rabbit cornea-derived cell line (SIRC-CVS) assay

 
       
07 MATREX

Cytyotoxicity test: Reconstructed human tissue (developed in Japan; MATREX)

 
       
08 EpiOcular-EIT

Reconstructed coreal tissue assay (EpiOcular)

 
06_08_Aen1.pdf     OECD GUIDELINE FOR THE TESTING OF CHEMICALS 06_08_Z1.pdf
09Skin Ethics

Collagen gel (Vitrigel)-eye irritation test (EIT)

 
       
10Vitrigel-EIT

Collagen gel (Vitrigel)-eye irritation test (EIT)

 
       
11LabCyte CORNEA-MODEL24-EIT

In vitro eye irritation test using Human Corneal Tissue (Model:LabCyte CORNEA-MODEL24)

 
       
12OECD TG No.405

Eye irritation assay using anesthetics

06_11_Aen1.pdf     OECD 40506_11_Z1.pdf
ICCVAM Test Method Evaluation Report06_11_Z2.pdf
Classification Test method Asign BThe Regulatory Acceptance Board Report CEditorial Report ZOthers
07Genotoxicity test 01OECD TG No.473,476,487,490

In vitro mammalian cell micronucleus test (chromosome abnormality test)

 
      07_01_Z1.pdf 
02In vitro comet assay

In vitro mammalian cell micronucleus test (chromosome abnormality test)

 
       
03In vivo comet assay

In vitro comet assay

 
       
04 Micronucleus test using EPiDerm

In vivo comet assay

 
       
08Acute oral toxicity test 01Cytotoxicity Test
(estimate starting doses for acute oral systemic toxicity tests)

Cytotoxicity Test(estimate starting doses for acute oral systemic toxicity tests)

08_01_Aen1.pdf 08_01_Ben1.pdf   BACKGROUND REVIEW DOCUMENT 1/208_01_Z1.pdf
BACKGROUND REVIEW DOCUMENT 2/208_01_Z2.pdf
02Cytotoxicity test
(LD50 ≧ 2000mg/Kg)

Cytotoxicity test (LD50 ≧ 2000mg/Kg)

 
       
09Endcrine disrupter screening 01ER-STTA
(agonist) (antagonist)

Estrogen receptor-stably transfected transactivation assay (ER-STTA) for the screening of agonistic activitiy of chemicals

 
09_01_Aen1.pdf      OECD GUIDELINE FOR THE TESTING OF CHEMICALS09_01_Z1.pdf
02BG1Luc ERTA

BG1Luc estrogen receptor transactivation assay (ERTA) for the screeing of agonistic and anti-agonistic activity of chemicals

09_02_Aen1.pdf     OECD 45709_02_Z1.pd
ICCVAM Test Method Evaluation Report09_02_Z2.pd
03CCi

CCi MCF-7 assay for the screening of estrogenic and anti-estrogenic activity of chemicals

 
       
04MELN

MELN (derived from MCF-7) cell assay for the screening of estrgenic and anti-estrogenic activity of chemicals

 
       
05AR-Ecoscreen

AR-EcoScreen (the cell line expressing androgen receptor) assay for the screening of androgenic activity of chemicals

 
       
06CERI In Vitro Estrogen Receptor Binding

AR-EcoScreen (the cell line expressing androgen receptor) assay for the screening of androgenic activity of chemicals

 
       
10Embryonic toxicoty scrneeing 01Hand1-Luc

Hand1-Luc Embryonic Stem Cell Test (Hand1-Luc EST)

 
       
11Metabolism 01CYP induction method

Cytochrome P-450 induction based metabolic-competent model system

 
       
12Immune toxicity test 01MITA

Bhas 42 cell transformation assay

 
       
13Cell transformation assay for the screening of carcinogenitic activity of chemicals 01Bhas

Bhas 42 cell transformation assay

 
       
02SHE

Syrian hamster embryo (SHE) cell transformation assay

 
       
03Balb

BALB/c 3T3 cell transformation assay

 
       
14Pyrogen screening test 01in vitro PBMC

in vitro pyrogen test method

    14_01_Ben1.pdf ECVAM statement14_01_Z1.pdf
ICCVAM Test Method Evaluation Report14_01_Z2.pdf
Classification Test method Asign BThe Regulatory Acceptance Board Report CEditorial Report ZOthers

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