Topic: Genotoxicity/Mutagenicity
Test Method Number:
TM2017-01 (EU)
Short Name of TM:
gH2AX/pH3
Year received:
2017
Responsible Organisation:
General Comments:
Presubmission assessment finalised. Method Not prioritised for validation
Method Description
The proposed method is based on gH2AX/pH3 biomarkers for the prediction of genotoxic potential of all kind of substances. The combination of the two biomarkers is proposed to detect early events in the DNA damage response and to discriminate structural and numerical chromosome damage. This assay is applicable to almost all cell types including cells of human origin. The assay use innovative techniques with a higher throughput than usual assays and potentially amenable to automation. The method is less prone to irrelevant positive results as compared to some of the current assays because is able to also discriminate the misleading cytotoxic chemicals.
Track Approval Status
-
Submission
-
Validation
-
Peer-review
-
Recommendation
-
Regulatory acceptance/Standards
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