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Results: 1 - 10 of 83

KeratinoSens assay for the testing of skin sensitizers

Test Method Number: TM2010-03 (EU)
Short Name of TM: KeratinoSens
Responsible Organisation: EURL ECVAM - European Union '
DB-ALM Protocol No.: 155
General Comments:

The validation was performed externally between 2009 and 2010

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

Skinethic Skin Irritation Test-42bis

Test Method Number: TM2008-02 (EU)
Short Name of TM: SkinEthic RHE
Responsible Organisation: EURL ECVAM - European Union '
DB-ALM Protocol No.: 135
General Comments:

Validation finalised, OECD Test Guideline / EU Test Method available

Stage of Submission: Assessment of presubmission
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

CYP induction assay using the cryopreserved human hepatocytes

Test Method Number: TM2009-13 (EU)
Short Name of TM: CryoHeps
Responsible Organisation: EURL ECVAM - European Union '
DB-ALM Protocol No.: 193
Stage of Submission: Not applicable
Stage of Validation: Finalised
Stage of Peer-review: Finalised
Stage of Regulatory acceptance/Standards: Drafting of new regulatory standard/guideline
  • 1
    Submission
  • 2
    Validation
  • 3
    Peer-review
  • 4
    Recommendation
  • 5
    Regulatory acceptance/Standards

CYP induction assay using the human cryopreserved HepaRG™ cell line

Test Method Number: TM2009-14 (EU)
Short Name of TM: HepaRG™
Responsible Organisation: EURL ECVAM - European Union '
DB-ALM Protocol No.: 194
Stage of Submission: Not applicable
Stage of Validation: Finalised
Stage of Peer-review: Finalised
Stage of Regulatory acceptance/Standards: Drafting of new regulatory standard/guideline
  • 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

Human Reconstructed Corneal Epithelium (HCE) Eye Irritation test

Test Method Number: TM2008-09 (EU)
Short Name of TM: SkinEthic HCE
Responsible Organisation: EURL ECVAM - European Union '
General Comments:

This test method was unable to comply fully with the acceptance criteria set by the validation management group. A revised SkinEthic™ HCE EIT test method was re-submitted for assessment by EURL ECVAM and formal ESAC peer review in October 2015 (See TM2015-03, SkinEthic-HCE-EIT).

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

Skin Irritation Test for the Prediction of Acute Skin Irritation of Chemicals With Sterlab RHE: 42 minutes application + 42 hours post-incubation

Test Method Number: TM2014-06 (EU)
Short Name of TM: Sterlab RHE SIT
Responsible Organisation: EURL ECVAM - European Union '
General Comments:

Further clarifications requested

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

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 '
DB-ALM Protocol No.: 138
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: Adopted
  • 1
    Submission
  • 2
    Validation
  • 3
    Peer-review
  • 4
    Recommendation
  • 5
    Regulatory acceptance/Standards

SkinEthic™ HCE Eye Irritation Test

Test Method Number: TM2015-03 (EU)
Short Name of TM: SkinEthic HCE EIT
Responsible Organisation: EURL ECVAM - European Union '
General Comments:

External validation performed. Report submitted for peer-review as full test submission.

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