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.

Note that TSAR includes only the methods that have been validated by governmental organisations affiliated with the International Cooperation on Alternative Test Methods (ICATM).

Furthermore, the documentation included in the TSAR database are the versions that were used during the validation of the respective test methods. These documents are provided for reference and transparency purposes only and may not correspond to the most up-to-date versions currently in use, nor can it be excluded that additional documentation exists. For the latest SOPs and technical information, users should contact the relevant test method developer. 

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Reconstructed Human Epidermis Model Test
TM Status: Closed
Test Method Number: TM2005-04 (EU)
Short Name of TM: EpiSkin™ - RHE
Responsible Organisation: EURL ECVAM - European Union 
Topic(s): Skin irritation
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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
Cytochrome P450 (CYP) enzyme induction in vitro method using the cryopreserved human hepatocytes
TM Status: Closed
Test Method Number: TM2009-13 (EU)
Short Name of TM: CryoHeps
Responsible Organisation: EURL ECVAM - European Union 
Topic(s): Toxicokinetics
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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
Epidermal Skin Corrosion Test 1000
TM Status: Closed
Test Method Number: TM2007-01 (EU)
Short Name of TM: Epics SCT
Responsible Organisation: EURL ECVAM - European Union 
Topic(s): Skin Corrosion
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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
Toxin Binding Inhibition test for batch potency testing of tetanus vaccines for human use
TM Status: Closed
Test Method Number: TM1999-05 (EU)
Short Name of TM: ToBI TET
Responsible Organisation: EURL ECVAM - European Union 
Topic(s): Quality control of vaccines
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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
ELISA test for batch potency testing of tetanus vaccines for human use
TM Status: Closed
Test Method Number: TM1999-04 (EU)
Short Name of TM: ELISA TET
Responsible Organisation: EURL ECVAM - European Union 
Topic(s): Quality control of vaccines
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    Submission
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    Validation
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    Peer-review
  •  
    Recommendation
  •  
    Regulatory acceptance/Standards