EpiDerm™ skin corrosivity test

Topic: Skin Corrosion

Test Method Number:

TM1998-03 (EU)

Short Name of TM:

EpiDerm™

Year received:

1998

Responsible Organisation:

EURL ECVAM - European Union

Protocol(s)/SOP(s):

119

General Comments:

Method Description

The test method is based on the commercially available EpiDerm™ model, a reconstructed human epidermal model grown from human-derived epidermal keratinocytes which are cultured to form a multilayered and highly differentiated model of the human epidermis. The corrosivity potential of chemicals is assessed with the measurement of their citotoxic effects on EpiDerm™ model.

Track Approval Status

Submission
Validation
Peer-review
Recommendation
Regulatory acceptance/Standards

Submission

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Date	Stage	Comment	Documents/Links
Jan 1998	Not applicable	See Validation step.

Validation

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Date	Stage	Comment	Documents/Links
Dec 1997	Finalised	Start of an ECVAM-sponsored prevalidation catch up study on the use of Epiderm<sup>TM</sup> for skin corrosivity testing, following the conclusion of the ECVAM Skin Corrosivity Validation Study.
Dec 1998	Finalised	Conclusion of the study and publication of results.

Peer-review

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Date	Stage	Comment	Documents/Links
Mar 2000	Finalised	Endorsement of the statement on the application of Epiderm<sup>TM</sup> human skin model for skin corrosivity testing at the 14th ESAC plenary meeting.	ESAC statement

Recommendation

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Date	Stage	Comment	Documents/Links
May 2000	Not applicable

Regulatory acceptance/Standards

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Date	Stage	Comment	Documents/Links
May 2002	Drafting of new regulatory standard/guideline	Project approved by the Working Group of the National Coordinators for the Test Guidelines Programme (WNT). Will be published as a new TG.
Apr 2004	Adopted/published	OECD TG 431 adopted.	Test guideline 431
May 2008	Adopted/published	Adaptation to technical progress TMR 440/2008. See Method B.40bis.	See consolidated version TMR