Automated screening to detect cardiotoxicity in zebrafish

Topic: Cardiotoxicity

Test Method Number:

TM2009-07 (EU)

Short Name of TM:

Zebrafish assay

Year received:

2009

Responsible Organisation:

EURL ECVAM - European Union

General Comments:

Further information was requested, but was not provided.

Method Description

Zebrafish embryos (48hpf) are exposed in a HTS system to test compounds and effects on heart rate, arrhythmia and death/fibrilation are automatically detected.

The aim of the method is to identify compounds that induce arrhythmia and consequently present a potential risk of QT interval prolongation. In addition, compounds that induce non zERG-related cardiotoxicity should be identified, to be classified as generally cardiotoxic.

The test is inteneded as screening method to detect cardiotoxicity of products in early stages of drug development.

Track Approval Status

Submission
Validation
Peer-review
Recommendation
Regulatory acceptance/Standards

Submission

Show status

Date	Stage	Comment
Dec 2009	Assessment of revised presubmission	Official notification of outcome. Clarification requested
Mar 2011	Assessment of revised presubmission	Second pre submission received
Jun 2011	Assessment finalised	Additional information requested. No answer received.
Oct 2020	Stopped	No further communication received from the submitter

Validation

Peer-review

Recommendation

Regulatory acceptance/Standards