Skinethic Skin Irritation Test-42bis

Topic: Skin irritation

Test Method Number:

TM2008-02 (EU)

Short Name of TM:

SkinEthic RHE

Year received:

2008

Responsible Organisation:

EURL ECVAM - European Union

Protocol(s)/SOP(s):

135

General Comments:

Validation finalised, OECD Test Guideline / EU Test Method available

Method Description

The SkinEthic™ Skin Irritation Test (42 minutes application + 42 hours post-incubation) is designed for the prediction of acute skin irritation potential of chemicals by measurement of their cytotoxic effect, as reflected by MTT assay, on the Reconstructed Human Epidermis (RHE).

Track Approval Status

Submission
Validation
Peer-review
Recommendation
Regulatory acceptance/Standards

Submission

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Date	Stage	Comment
Jan 1970	Assessment of full submission
Apr 2008	Receipt of full submission	Full test submission was submitted to EURL ECVAM for review.
Jun 2008	Assessment finalised	Outcome of submission and qualification to proceed to peer review. See Peer review step.

Validation

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Date	Stage	Comment	Documents/Links
Apr 2008	Finalised	Validation was performed externally and not coordinated by EURL ECVAM. See Submission step.

Peer-review

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Date	Stage	Comment	Documents/Links
Nov 2008	Finalised	ESAC Statement on the scientific validity of in vitro tests for skin irritation testing including SkinEthic was endorsed at the 29th ESAC meeting.	ESAC statement
Nov 2008	Finalised	Statement of the scientific validity of in vitro tests for skin irritation testing at 29th ESAC plenary meeting.	Peer Review SkinEthic

Recommendation

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Date	Stage	Comment	Documents/Links
Jul 2010	Not applicable

Regulatory acceptance/Standards

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Date	Stage	Comment	Documents/Links
Jul 2010	Adopted/published	OECD TG439 was adopted.	Test Guideline 439