TRACKING SYSTEM FOR ALTERNATIVE METHODS TOWARDS REGULATORY ACCEPTANCE

TSAR indicates the stages methods have reached in terms of acceptance as a recognised test method for use in various sectors together with a summary description. Where available, TSAR also includes relevant records and documents associated with a method linked to the different steps of the entire process: submission, validation, peer-review, recommendations and regulatory acceptance including international standards represented in the tracking system.

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KeratinoSens assay for the testing of skin sensitizers
TM Status: Closed
Test Method Number: TM2010-03 (EU)
Short Name of TM: KeratinoSens
Responsible Organisation: EURL ECVAM - European Union 
Topic(s): Skin sensitisation
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    Submission
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    Validation
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    Peer-review
  •  
    Recommendation
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    Regulatory acceptance/Standards
H2AX ICW method, gH2AX In cell western
TM Status: Closed
Test Method Number: TM2014-02 (EU)
Short Name of TM: H2AX ICW
Responsible Organisation: EURL ECVAM - European Union 
Topic(s): Genotoxicity/Mutagenicity
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    Submission
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    Validation
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    Peer-review
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    Recommendation
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    Regulatory acceptance/Standards
gH2AX/pH3 biomarkers for the prediction of DNA damage
TM Status: Closed
Test Method Number: TM2017-01 (EU)
Short Name of TM: gH2AX/pH3
Responsible Organisation: EURL ECVAM - European Union 
Topic(s): Genotoxicity/Mutagenicity
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    Submission
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    Validation
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    Peer-review
  •  
    Recommendation
  •  
    Regulatory acceptance/Standards
Thyroid receptor microarray assay for real-time Nuclear Receptor-coregulator interaction
TM Status: Open
Test Method Number: TM2017-02 (EU)
Short Name of TM: TR MARCoNI
Responsible Organisation: EURL ECVAM - European Union 
Topic(s): Endocrine disruption
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    Submission
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    Validation
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    Peer-review
  •  
    Recommendation
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    Regulatory acceptance/Standards
GreenScreen HC TM Genotoxicity Assay
TM Status: Closed
Test Method Number: TM2009-08 (EU)
Short Name of TM: Greenscreen
Responsible Organisation: EURL ECVAM - European Union 
Topic(s): Genotoxicity/Mutagenicity
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    Submission
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    Validation
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    Peer-review
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    Recommendation
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    Regulatory acceptance/Standards
Human Reconstructed Corneal Epithelium (HCE) Eye Irritation test
TM Status: Closed
Test Method Number: TM2008-09 (EU)
Short Name of TM: SkinEthic HCE
Responsible Organisation: EURL ECVAM - European Union 
Topic(s): Serious eye damage/Eye irritation
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    Submission
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    Validation
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    Peer-review
  •  
    Recommendation
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    Regulatory acceptance/Standards
LuSens Assay
TM Status: Closed
Test Method Number: TM2011-10 (EU)
Short Name of TM: LuSens
Responsible Organisation: EURL ECVAM - European Union 
Topic(s): Skin sensitisation
  •  
    Submission
  •  
    Validation
  •  
    Peer-review
  •  
    Recommendation
  •  
    Regulatory acceptance/Standards
Skin Irritation Test for the Prediction of Acute Skin Irritation of Chemicals With Sterlab RHE: 42 minutes application + 42 hours post-incubation
TM Status: Open
Test Method Number: TM2014-06 (EU)
Short Name of TM: Sterlab RHE SIT
Responsible Organisation: EURL ECVAM - European Union 
Topic(s): Skin irritation
  •  
    Submission
  •  
    Validation
  •  
    Peer-review
  •  
    Recommendation
  •  
    Regulatory acceptance/Standards
Direct Peptide Reactivity Assay
TM Status: Closed
Test Method Number: TM2009-06 (EU)
Short Name of TM: DPRA
Responsible Organisation: EURL ECVAM - European Union 
Topic(s): Skin sensitisation
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    Submission
  •  
    Validation
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    Peer-review
  •  
    Recommendation
  •  
    Regulatory acceptance/Standards
In vitro production of monoclonal antibodies (hybridoma technique)
TM Status: Closed
Test Method Number: TM1998-04 (EU)
Short Name of TM: In vitro mAbs
Responsible Organisation: EURL ECVAM - European Union 
Topic(s): Human health
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    Submission
  •  
    Validation
  •  
    Peer-review
  •  
    Recommendation
  •  
    Regulatory acceptance/Standards