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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Cell Transformation Assay Based on the Bhas 42 Cell Line
TM Status: Open
Test Method Number: TM2012-06 (EU)
Short Name of TM: Bhas 42 CTA
Responsible Organisation: EURL ECVAM - European Union 
Topic(s): Carcinogenicity
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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
3D Reconstructed Human Skin Comet assay
TM Status: Open
Test Method Number: TM2020-01 (EU)
Short Name of TM: RS Comet assay
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
3D Reconstructed Human Skin Micronucleus assay (RSMN)
TM Status: Open
Test Method Number: TM2020-04 (EU)
Short Name of TM: RSMN
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
Cytochrome P450 (CYP) enzyme induction in vitro method using cryopreserved differentiated human HepaRG™ cells
TM Status: Open
Test Method Number: TM2009-14 (EU)
Short Name of TM: HepaRG™
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
In Vitro Skin Sensitisation: The FBS free ARE-Nrf2 Luciferase α-Sens® Test Method
TM Status: Open
Test Method Number: TM2022-03 (JAP)
Short Name of TM: α-Sens®
Responsible Organisation: JaCVAM - Japan
Topic(s): Skin sensitisation
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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