Japanese Center for the Validation of Alternative Methods
Office : New Testing Method Assessment, Division of Pharmacology,
National Biological Safety Research Center (NBSRC),
National Institute of Health Sciences (NIHS)

JaCVAM Activities

JaCVAM Statements

Acute oral systemic toxicity test

• JaCVAMStatement on the cytotoxicity tests to estimate starting doses for acute oral systemic toxicity tests (194 KB)
  07_001_02.pdf　
  
  
• The Regulatory Acceptance Board Report (202 KB)
  07_001_04_en.pdf　

Skin sensitization test (LLNA-BrdU)

• 【NEW】The Regulatory Acceptance Board Report on revisions to judgment criteria used for the LLNA: BrdU-ELISA (66 KB) 
  LLNA-Brdu-ELISA_04_en.pdf 


• JaCVAM statement on the Local Lymph Node Assay(LLNA):BrdU-ELISA for skin sensitization assay (35 KB) 
  LLNA-Brdu-ELISA_02.pdf 


• JaCVAMStatement on the LLNA: BrdU-ELISA for skin sensitization testing (927 KB)
  03_002_13.pdf　
  
  
• The Regulatory Acceptance Board Report (152 KB)
  03_002_03_en.pdf　

Skin irritation test(EPISKIN)

• 【NEW】The Regulatory Acceptance Board Report on an alternative skin irritation test method using EpiDerm and SkinEthics (66 KB) 
  EpiDerm_04_en.pdf 


• JaCVAM statement on the two in vivo assays for skin irritation testing (36 KB) 
  EpiDerm_02.pdf 


• JaCVAM Statement on the in vitro tests for skin irritation(250 KB)
  04_001_08.pdf　


• The Regulatory Acceptance Board Report (159 KB)
  04_001_04_en.pdf　

Isolated Chiken Eye Test

• JaCVAM Statement on in vitro ocular toxicity test methods for identifying ocular corrosive and severe irritants: Isolated Chiken Eye Test Method (472 KB)
  05_001_08.pdf　
  
  
• Peer Review Panel Report (86 KB)
  05_001_05_en.pdf　
  
  
• The Regulatory Acceptance Board Report (133 KB)
  05_001_04_en.pdf　

Bovine Corneal Opacity and Permeability Test

• JaCVAM Statement on in vitro ocular toxicity test methods for identifying ocular corrosive and severe irritants: Bovine Corneal Opacity and Permeability Test Method (466 KB)
  05_002_08.pdf　


• Peer Review Panel Report (86 KB)
  05_002_05_en.pdf　


• The Regulatory Acceptance Board Report (135 KB)
  05_002_04_en.pdf　

Fluorescein Leakage Test Method

• 【NEW】The Regulatory Acceptance Board Report on the fluorescein leakage test method for evaluation of ocular irritation potency (91 KB)
   Fluorescein_04_en.pdf 


• JaCVAM statement on the Fluorescein Leakage Test Method for Identifying Ocular Corrosives and Severe Irritants (37 KB)
   Fluorescein_02.pdf 

Reconstructed human tissue test made in Japan:Vitrolife-Skin

• JaCVAM Statement on the Vitrolife-SkinTM,a3-dimensional cultured skin model for skin corrosivity testing(954KB)
  01_001_05_en.pdf　


• Peer Review Panel Report (140 KB)
  01_001_03_en.pdf　


• The Regulatory Acceptance Board Report (138 KB)
  01_001_04_en.pdf　

Skin sensitization test (LLNA-DA)

• 【NEW】The Regulatory Acceptance Board Report on revisions to judgment criteria used for the LLNA: DA (67 KB) 
  LLNA-DA_04_en.pdf 


• JaCVAM statement on the Local Lymph Node Assay(LLNA):DA for skin sensitization assay (34 KB) 
  LLNA-DA_02.pdf 


• JaCVAMStatement on the LLNA-DA for skin sensitization testing(506KB)
  03_001_01_en.pdf　
  
  
• The Regulatory Acceptance Board Report (122 KB)
  03_001_02_en.pdf　

Reduced Local Lymph Node Assay(rLLNA)

• 【NEW】The Regulatory Acceptance Board Report on an alternative skin sensitization test method, Reduced Local Lymph Node Assay (rLLNA) (67 KB)
   rLLNA_04_en.pdf 


• JaCVAM statement on the Reduced Local Lymph Node Assay(rLLNA) for skin sensitization assay (35 KB)
   rLLNA_02.pdf 

Phototoxicity test

• Peer Review Panel Report (372 KB)
  02_002_03_en.pdf　


• The Regulatory Acceptance Board Report (134 KB)
  02_002_02_en.pdf　

In Vitro pyrogen test

• The Regulatory Acceptance Board Report (148 KB)
  10_001_03_en.pdf