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The LUMI-CELL® ER Test Method: An In Vitro Assay for Identifying Human Estrogen Receptor Agonist and Antagonist Activity of Chemicals

Test Method Number: TM2016-03 (US)
Short Name of TM: VM7Luc ER TA assay
Topic(s): Reproductive toxicity - Endocrine disruption
Responsible Organisation: ICCVAM/NICEATM - United States
General Comments: This test method was originally referred to as the BG1Luc ER TA method. In June 2016, NICEATM received new information regarding the BG1Luc estrogen receptor (ER) transactivation (LUMI-CELL®) assay (TA). DNA testing has now shown that the original cell line used to develop the assay was not the BG1 human ovarian carcinoma cell line, but was instead a variant of the MCF7 human breast cancer cell line. The cell line used in the assay, originally referred to as BG1Luc4E2 (Rogers and Denison, 2000), will now be designated as VM7Luc4E2 (“V” = variant; “M7” = MCF7 cells). Likewise, the assay will now be designated as the VM7Luc ER TA. While this changes the origin of the cell line upon which the assay is based, it does not affect published validation studies nor the utility and application of this assay for screening of estrogenic/anti-estrogenic chemicals.
Stage of Submission: Assessment Finalised
Stage of Validation: Finalised
Stage of Peer-review: Finalised
Stage of Recommendation: Published
Stage of Regulatory acceptance/Standards: Adopted
  • 1
    Submission
  • 2
    Validation
  • 3
    Peer-review
  • 4
    Recommendation
  • 5
    Regulatory acceptance/Standards

The ToxCast Estrogen Receptor Agonist Pathway Model

Test Method Number: TM2016-02 (US)
Short Name of TM: ToxCast ER Pathway Model
Topic(s): Reproductive toxicity - Endocrine disruption
Responsible Organisation: ICCVAM/NICEATM - United States
Stage of Submission: Assessment Finalised
Stage of Validation: Finalised
Stage of Peer-review: Finalised
Stage of Recommendation: Published
Stage of Regulatory acceptance/Standards: Adopted
  • 1
    Submission
  • 2
    Validation
  • 3
    Peer-review
  • 4
    Recommendation
  • 5
    Regulatory acceptance/Standards

Transcriptional activation assay for detection of androgenic activity of chemicals

Test Method Number: TM2010-07 (EU)
Short Name of TM: AR-CALUX
Topic(s): Reproductive toxicity - Endocrine disruption
Responsible Organisation: EURL ECVAM - European Union
General Comments: Under validation
Stage of Submission: Assessment Finalised
Stage of Validation: Ongoing
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    Submission
  • 2
    Validation
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    Peer-review
  • 4
    Recommendation
  • 5
    Regulatory acceptance/Standards

Transactivation assay for detection of compounds with (anti)androgenic potential using PALM cells

Test Method Number: TM2010-02 (EU)
Short Name of TM: PALM cell assay
Topic(s): Reproductive toxicity - Endocrine disruption
Responsible Organisation: EURL ECVAM - European Union
General Comments: Not prioritised for validation by ECVAM due to issues regarding the material transfer agreement
Stage of Submission: Not considered for validation
  • 1
    Submission
  • 2
    Validation
  • 3
    Peer-review
  • 4
    Recommendation
  • 5
    Regulatory acceptance/Standards

Rat recombinant androgen receptor binding assay for the detection of compounds with (anti)androgenic potential

Test Method Number: TM2010-01 (EU)
Short Name of TM: ARBA
Topic(s): Reproductive toxicity - Endocrine disruption
Responsible Organisation: EURL ECVAM - European Union
General Comments: Not prioritised for validation by ECVAM
Stage of Submission: Not considered for validation
  • 1
    Submission
  • 2
    Validation
  • 3
    Peer-review
  • 4
    Recommendation
  • 5
    Regulatory acceptance/Standards

Prediction of the in vivo estrogenic activity of chemicals ERalpha-CALUX

Test Method Number: TM2009-11 (EU)
Short Name of TM: ERalpha-CALUX
Topic(s): Reproductive toxicity - Endocrine disruption
Responsible Organisation: EURL ECVAM - European Union
General Comments: Not prioritised for validation by ECVAM. External validation performed.
Stage of Submission: Not considered for validation
Stage of Regulatory acceptance/Standards: Published
  • 1
    Submission
  • 2
    Validation
  • 3
    Peer-review
  • 4
    Recommendation
  • 5
    Regulatory acceptance/Standards

Transactivation assay for detection of compounds with (anti)estrogenic potential using MELN cells

Test Method Number: TM2009-02 (EU)
Short Name of TM: MELN
Topic(s): Reproductive toxicity - Endocrine disruption
Responsible Organisation: EURL ECVAM - European Union
General Comments: Validation stopped after consultation with test submitter
Stage of Submission: Not considered for validation
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    Submission
  • 2
    Validation
  • 3
    Peer-review
  • 4
    Recommendation
  • 5
    Regulatory acceptance/Standards

Waring test for endocrine disruptor identification

Test Method Number: TM2008-07 (EU)
Short Name of TM: Waring test
Topic(s): Reproductive toxicity - Endocrine disruption
Responsible Organisation: EURL ECVAM - European Union
General Comments: On hold-pending further information
Stage of Submission: Assessment of Pre-submission
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    Submission
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    Validation
  • 3
    Peer-review
  • 4
    Recommendation
  • 5
    Regulatory acceptance/Standards

Yeast Estrogen and Yeast Androgen Screening Assays

Test Method Number: TM2011-03 (EU)
Short Name of TM: YES / YAS
Topic(s): Reproductive toxicity - Endocrine disruption
Responsible Organisation: EURL ECVAM - European Union
General Comments: After prioritization, only the YAS assay was submitted as a full submission, after an external validation.
Stage of Submission: Assessment Finalised
  • 1
    Submission
  • 2
    Validation
  • 3
    Peer-review
  • 4
    Recommendation
  • 5
    Regulatory acceptance/Standards
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