Epidermal Skin Corrosion Test 1000

Topic: Skin Corrosion

Test Method Number:

TM2007-01 (EU)

Short Name of TM:

Epics SCT

Year received:

2007

Responsible Organisation:

EURL ECVAM - European Union

General Comments:

Preceding TM:

TM2009-09 - epiCS Skin Irritation Test

Method Description

The EpiCS (previously called EST-1000) Skin Corrosion Test (SCT) can be used to assess the potential of chemicals to cause skin corrosion.
The epiCS model is a reconstructed epidermis consisting of proliferating and differentiating keratinocytes. The test is based on the notion that skin corrosion is in part due to cytotoxic effects of chemicals. As such, it involves the exposure of the cells to test chemicals and subsequent determination of cytotoxicity via the MTT assay. The MTT assay is used to determine cytotoxicity, which is then expressed as a % of the negative control. A positive control is also included in the assay. The test is available as a commercial kit.

Track Approval Status

Submission
Validation
Peer-review
Recommendation
Regulatory acceptance/Standards

Submission

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Date	Stage	Comment
Sep 2007	Receipt of full submission	Submission of Epics SCT (former EST-1000 for skin corrosion test) including valiadtion study
Apr 2008	Receipt of revised full submission	Reception of the Review of the in vitro EST-1000 Skin Corrosion Test (SCT) including report on "catch-up"/ "me-too"" validation study.
Apr 2008	Assessment of full submission	ESAC feedback on the "catch-up"/ "me-too" validation study of Epics SCT (former EST-1000 on skin corrosion)
Nov 2008	Assessment finalised	Between 6 November 2008 and 16 February 2009 the submitter provided feedback on the performance of Epics SCT in comparison with previous validated methods (EpiSkin, EpiDerm and SkinEthic) using retrospective and newly generated data. Results ere discussed in the 28th and 29th ESAC plenary meetings, being accepted.

Validation

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Date	Stage	Comment	Documents/Links
Dec 2007	Finalised	Validation study was performed externally, not coordinated by EURL ECVAM. Please see Submission step.

Peer-review

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Date	Stage	Comment	Documents/Links
May 2008	Ongoing	First discussion of the Epics SCT method at the 28th ESAC meeting.
Nov 2008	Ongoing	Presentation by the ESAC members of the feedback provided to the submitter on the comparison performance study.
Mar 2009	Finalised	ESAC Statement following the 30th ESAC meeting. It was recognized the scientific validity of EST-100 to test Skin Corrosion. The test can be used for reliably predicting the corrosive potential of chemical substances. It is considered meeting the Performance Standards as determined in the OECD test guideline TG 431 on in vitro skin corrosion testing using human skin model tests.	ESAC Statment

Recommendation

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Date	Stage	Comment	Documents/Links
Apr 2012	Not applicable

Regulatory acceptance/Standards

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Date	Stage	Comment	Documents/Links
Apr 2012	Revision of existing regulatory standard/guideline	Project approved and included in the OECD Work Plan by Working Group of the National Coordinators for the Test Guidelines Programme (WNT) to update TG 431.
Apr 2016	Adopted/published	Updated version of OECD TG431 was adopted.	TG431