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Transactivation 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
Year received: 2010
Responsible Organisation: EURL ECVAM - European Union '
Protocol(s)/SOP(s): ar-calux sop, data analysis templates
General Comments:

The AR-CALUX method was submitted by BioDetection Systems (The Netherlands) for a EURL ECVAM coordinated validation study.  The experimental part was concluded by the end of 2018 and the report reviewed by ESAC in June 2019.  The draft TG (TG458) was submitted to OECD mid June 2019, for commenting rounds to start at WNT.  The TG458 was adopted (April 2020) and published(June 2020).  This TG includes 3 validated ARTA methods: AR-EcoScreen from Japan, AR-CALUX from the Netherlands, 22Rv1/MMTV_GR-KO assay from Korea.

Method Description

Androgen Receptor TransActivation assay (ARTA).  This method makes use 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.

 

Track Approval Status

  • Submission
  • Validation
  • Peer-review
  • Recommendation
  • Regulatory acceptance/Standards
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