Stably Transfected Human Estrogen Receptor-α Transactivation Assay using the (h) ERα-HeLa-9903 cell line

Topic: Endocrine disruption

Test Method Number:

TM2008-17 (JAP)

Short Name of TM:

ER-STTA assay

Year received:

2008

Responsible Organisation:

JaCVAM - Japan

General Comments:

Method Description

This transactivation (TA) assay uses the (h) ERα-HeLa-9903 cell line to detect estrogenic agonist activity mediated through human estrogen receptor alpha ((h) ERα). This test method is specifically designed to detect (h) ERα-mediated TA by measuring chemiluminescence as the endpoint.

Track Approval Status

Submission
Validation
Peer-review
Recommendation
Regulatory acceptance/Standards

Submission

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Date	Stage	Comment	Documents/Links
Jan 2008	Assessment finalised	A formal assessment of the test submission was conducted by OECD. The test submitter was informed of the positive outcome.

Validation

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Date	Stage	Comment	Documents/Links
Dec 2014	Finalised	Completion of the validation with validation report. Publication of the report by the Validation Management Team.	Draft Report of Pre-validation and Inter-laboratory Validation For Stably Transfected Transcriptional Activation (TA) Assay to Detect Estrogenic Activity

Peer-review

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Date	Stage	Comment	Documents/Links
Nov 2013	Finalised	Peer Review Panel submitted the peer review report of the ER-STTA assay using the (h) ERα-HeLa-9903 cell line. Publication of the Peer Review report.	Summary Report of the Peer Review Panel on the Stably Transfected Transcriptional Activation Assay for Detecting Estrogenic Activity of Chemicals, and Agreement of the Working Group of the National Coordinators of the Test Guidelines Programme on the Foll

Recommendation

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Date	Stage	Comment	Documents/Links
Nov 2013	Not applicable

Regulatory acceptance/Standards

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Date	Stage	Comment	Documents/Links
Jul 2016	Adopted/published	Chemicals Evaluation and Research Institute (CERI) and JaCVAM submitted a draft test guideline and related documents to the OECD for consideration of the ER-STTA assay using the (h) ERα-HeLa-9903 cell line as an OECD Test Guideline, which was formally adopted by the OECD.	Test No. 455: Performance-Based Test Guideline for Stably Transfected Transactivation In Vitro Assays to Detect Estrogen Receptor Agonists and Antagonists