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Results: 1 - 10 of 76

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

Test Method Number: TM2016-09 (US)
Short Name of TM: VM7Luc ER TA
Responsible Organisation: ICCVAM/NICEATM - United States '
DB-ALM Protocol No.: 455
General Comments: This test method was originally referred to as the BG1Luc ER TA method.
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

Hemi-Diaphragm Assay (HDA) for detection and quantification of botulinum neurotoxins (BoNT)

Test Method Number: TM2015-01 (EU)
Short Name of TM: HAD BoNT
Responsible Organisation: EURL ECVAM - European Union '
General Comments:

Not considered for follow-up

Stage of Submission: Not considered for validation
  • 1
    Submission
  • 2
    Validation
  • 3
    Peer-review
  • 4
    Recommendation
  • 5
    Regulatory acceptance/Standards

Genomic Embryonic Stem cell Test method

Test Method Number: TM2012-04 (EU)
Short Name of TM: gEST
Responsible Organisation: EURL ECVAM - European Union '
General Comments:

Not considered for follow-up

Stage of Submission: Assessment finalised
  • 1
    Submission
  • 2
    Validation
  • 3
    Peer-review
  • 4
    Recommendation
  • 5
    Regulatory acceptance/Standards

Ashland Skin Irritation Test

Test Method Number: TM2015-02 (EU)
Short Name of TM: Ashland RhE SIT
Responsible Organisation: EURL ECVAM - European Union '
General Comments:

Similar test method to already validated and accepted ones. Not considered for follow-up

Stage of Submission: Assessment finalised
  • 1
    Submission
  • 2
    Validation
  • 3
    Peer-review
  • 4
    Recommendation
  • 5
    Regulatory acceptance/Standards

U-SENS™ - Myeloid U937 Skin Sensitisation Test

Test Method Number: TM2013-02 (EU)
Short Name of TM: U-SENS™
Responsible Organisation: EURL ECVAM - European Union '
DB-ALM Protocol No.: 183
General Comments:

The U-SENS™ test method was formely called Myeloid U937 Skin Sensitisation Test (MUSST) (TM 2009-05).

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

Bioaccessibility testing (Bioelution) of metals, inorganic metals compounds and metals-containing materials: simulated gastric fluid

Test Method Number: TM2016-02 (EU)
Short Name of TM: Bioelution
Responsible Organisation: EURL ECVAM - European Union '
General Comments:

Test submitter invited to send full submission

Stage of Submission: Receipt of full submission
  • 1
    Submission
  • 2
    Validation
  • 3
    Peer-review
  • 4
    Recommendation
  • 5
    Regulatory acceptance/Standards

EpiOcular™ Human Cell Construct EIT

Test Method Number: TM2008-10 (EU)
Short Name of TM: EpiOcular EIT
Responsible Organisation: EURL ECVAM - European Union '
DB-ALM Protocol No.: 164
Stage of Submission: Assessment finalised
Stage of Validation: Finalised
Stage of Peer-review: Finalised
Stage of Regulatory acceptance/Standards: Adopted
  • 1
    Submission
  • 2
    Validation
  • 3
    Peer-review
  • 4
    Recommendation
  • 5
    Regulatory acceptance/Standards

Direct Peptide Reactivity Assay

Test Method Number: TM2009-06 (EU)
Short Name of TM: DPRA
Responsible Organisation: EURL ECVAM - European Union '
DB-ALM Protocol No.: 154
General Comments:

Validation finalised, ECVAM Recommendation published, OECD TG available

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

GreenScreen HC TM Genotoxicity Assay

Test Method Number: TM2009-08 (EU)
Short Name of TM: Greenscreen
Responsible Organisation: EURL ECVAM - European Union '
DB-ALM Protocol No.: 132
General Comments:

The test method underwent an external (non EURL ECVAM-coordinated) validation study and all available information/data were submitted for a Retrospective Validation. Following consultation with EURL ECVAM network of regulators (PARERE - Preliminary Assessment of Regulatory Relevance), the test method did not progress to peer review.

Stage of Submission: Assessment finalised
  • 1
    Submission
  • 2
    Validation
  • 3
    Peer-review
  • 4
    Recommendation
  • 5
    Regulatory acceptance/Standards

LuSens Assay

Test Method Number: TM2011-10 (EU)
Short Name of TM: LuSens
Responsible Organisation: EURL ECVAM - European Union '
DB-ALM Protocol No.: 184
General Comments:

The Lu-Sens underwent an external catch-up validation study based on the performance standards for in vitro skin sensitisation ARE-NrF2 luciferase test methods (OECD 2015).

Stage of Submission: Assessment finalised
Stage of Validation: Finalised
Stage of Peer-review: Finalised
Stage of Recommendation: Published
Stage of Regulatory acceptance/Standards: Revision of existing regulatory standard/guideline
  • 1
    Submission
  • 2
    Validation
  • 3
    Peer-review
  • 4
    Recommendation
  • 5
    Regulatory acceptance/Standards