GreenScreen HC TM Genotoxicity Assay
Topic : Genotoxicity/Mutagenicity
| Test Method Number: | TM2009-08 (EU) |
|---|---|
| Short Name of TM: | Greenscreen |
| Year received: | 2009 |
| Responsible Organisation: | EURL ECVAM - European Union ' |
| Protocol(s)/SOP(s): | 132 |
| General Comments: |
The test method underwent an external (non EURL ECVAM-coordinated) validation study and all available information/data were submitted for a Retrospective Validation. Following consultation with EURL ECVAM network of regulators (PARERE - Preliminary Assessment of Regulatory Relevance), the test method did not progress to peer review. |
Method Description
Specifically, the GSHC is a microplate format genotoxicity plus cytotoxicity screening assay which uses the DNA damage-inducible "Growth Arrest and DNA Damage 45 alpha" (GADD45a) - Green Fluorescent Protein (GFP) reporter gene, expressed in the p53-competent human lymphoblastoid TK6 cell line.
The Submitter has proposed the test method for both regulatory and non-regulatory genotoxicity assessment: (A) for compound discovery and development screening applications; (B) as additional test to be used in Option2 under ICH S2(R1); (C) as stand-alone test alternative to the in vitro battery; (D) to support weight of evidence arguments in regulatory safety assessment of in vitro genotoxicity battery data - where genotoxicity data from other tests are...
Track Approval Status
- Submission
- Validation
- Peer-review
- Recommendation
- Regulatory acceptance/Standards
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