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Transcriptional activation assay for detection of androgenic activity of chemicals

Topic : Reproductive toxicity, Endocrine disruption

Test Method Number: TM2010-07 (EU)
Short Name of TM: AR-CALUX
Submission received on: December, 2010
Responsible Organisation: EURL ECVAM - European Union
Stage of Submission: Assessment Finalised
Stage of Validation: Ongoing
General Comments:

Under validation

Method Description

Androgen Receptor Transcriptional Activation assay (ARTA).  This method makes uses of the osteosarcoma celline U2-OS which has been transfected with the full cDNA for the human androgen receptor (pSG5-neo-hAR), and, a reporter gene for luciferase expression under control of a limited promoter and a triple tandem of upstream elements ARE (pGL3-3XAREtataLuc).

This method provides information on the (anti-) androgenic activity of substances when the AR-CALUX cells are exposed, leading to luminescence.  The measurements and the classification model allow to predict if substances have a positive or negative reponse for either the agonist or antagonist mode of the method. This method is intended for screening purposes.

After a successful validation, this method will be part of a set of methods on basis of which a Performance Based Test Guideline for ARTAs will be developed.

Track Approval Status

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    Regulatory acceptance/Standards
CompletedSubmissionShow status
In progressValidationShow status
 Regulatory acceptance/Standards