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Modified EpiDerm Skin Irritation Test for Hazard Identification and Labelling of Chemicals According to EU Classification System

Test Method Number: TM2008-01 (EU)
Short Name of TM: Modified EpiDerm SIT
Responsible Organisation: EURL ECVAM - European Union
General Comments:

Validation finalised, OECD Test Guideline / EU Test Method available

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

Epidermal Skin Test 1000

Test Method Number: TM2009-09 (EU)
Short Name of TM: EST-1000/epiCS
Responsible Organisation: EURL ECVAM - European Union
General Comments:

ESAC peer review requested additional testing

Stage of Submission: Assessment of Full submission
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

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 assay
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: TM2016-08 (US)
Short Name of TM: ToxCast ER Pathway Model
Responsible Organisation: ICCVAM/NICEATM - United States
General Comments:
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 Electrophilic Allergen Screening Assay for the Detection of Substances Causing Allergic Contact Dermatitis

Test Method Number: TM2016-07 (US)
Short Name of TM: EASA
Responsible Organisation: ICCVAM/NICEATM - United States
General Comments:
Stage of Submission: Assessment Finalised
Stage of Validation: Planning
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    Submission
  • 2
    Validation
  • 3
    Peer-review
  • 4
    Recommendation
  • 5
    Regulatory acceptance/Standards

Bovine Oocyte Maturation Assay

Test Method Number: TM2010-05 (EU)
Short Name of TM: IVM
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
  • 2
    Validation
  • 3
    Peer-review
  • 4
    Recommendation
  • 5
    Regulatory acceptance/Standards

A new in vitro eye irritation test with a 3D-reconstructed human cornea epithelium, MCTT HCE™

Test Method Number: TM2016-04 (KOR)
Short Name of TM: MCTT HCE™-EIT
Responsible Organisation: KoCVAM - Republic of Korea
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

Automated screening to detect cardiotoxicity in zebrafish

Test Method Number: TM2009-07 (EU)
Short Name of TM: Zebrafish assay
Responsible Organisation: EURL ECVAM - European Union
General Comments: On hold-pending further information
Stage of Submission: Assessment of Pre-submission
  • 1
    Submission
  • 2
    Validation
  • 3
    Peer-review
  • 4
    Recommendation
  • 5
    Regulatory acceptance/Standards

Bioaccessibility testing from powder and massive samples of metals and alloys

Test Method Number: TM2011-04 (EU)
Short Name of TM: Bioaccess
Responsible Organisation: EURL ECVAM - European Union
General Comments: Not considered for follow-up. The test method did not meet the criteria to enter the EURL ECVAM validation process.
Stage of Submission: Not considered for validation
  • 1
    Submission
  • 2
    Validation
  • 3
    Peer-review
  • 4
    Recommendation
  • 5
    Regulatory acceptance/Standards

Cell Transformation Assay Based on the Bhas 42 Cell Line

Test Method Number: TM2012-06 (EU)
Short Name of TM: Bhas 42 CTA
Responsible Organisation: EURL ECVAM - European Union
General Comments: The validation of this assay was coordinated by the Japanese Center for the Validation of Alternative Methods (JaCVAM), while the peer review was conducted by ESAC.
Stage of Submission: Assessment Finalised
Stage of Validation: Finalised
Stage of Peer-review: Finalised
Stage of Recommendation: Published
Stage of Regulatory acceptance/Standards: Published
  • 1
    Submission
  • 2
    Validation
  • 3
    Peer-review
  • 4
    Recommendation
  • 5
    Regulatory acceptance/Standards