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

The Green Screen HCTM (GSHC) assay is an in vitro human cell-based genotoxicity test method intended to predict the in vivo genotoxic potential of chemicals.

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 conflicting.

Track Approval Status

  •  
    Submission
  •  
    Validation
  •  
    Peer-review
  •  
    Recommendation
  •  
    Regulatory acceptance/Standards
Step
Submission Show status
Validation
Peer-review
Recommendation
Regulatory acceptance/Standards