SkinEthic™ HCE Eye Irritation Test

Topic: Serious eye damage/Eye irritation

Test Method Number:

TM2015-03 (EU)

Short Name of TM:

SkinEthic HCE EIT

Year received:

2015

Responsible Organisation:

EURL ECVAM - European Union

General Comments:

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

Preceding TM:

TM2008-09 - Human Reconstructed Corneal Epithelium (HCE) Eye Irritation test

Method Description

The SkinEthic™ Human Corneal Epithelium (HCE) Eye Irritation Test (EIT) method is an in vitro assay used for assessing eye irritation/serious eye damage. The method uses a reconstructed human cornea-like epithelium (RhCE) consisting of a multilayered epithelium prepared from immortalized human corneal epithelial cells which reproduce the multi-layer organization of the human cornea. The tissues are exposed to the test chemicals according to two possible protocols, depending on the physical state of the test chemical either solid "EITS" protocol (see DB-ALM protocol No.191), or liquid/viscous "EITL" protocol ( see DB-ALM protocol No.190).

Track Approval Status

Submission
Validation
Peer-review
Recommendation
Regulatory acceptance/Standards

Submission

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Date	Stage	Comment
Oct 2015	Receipt of full submission	A full test submission was submitted to EURL ECVAM for peer-review. Pre-submission was not received because the test method followed up a previous validation study coordinated by EURL ECVAM (see TM2008-09).
Mar 2016	Receipt of full submission	A revised submission was made to amend some inaccuracies in the full test submission.
May 2016	Assessment finalised	A formal assessment of the revised test submission was conducted by EURL ECVAM. The test submitter was informed of the positive outcome.

Validation

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Date	Stage	Comment	Documents/Links
Mar 2016	Finalised	The validation study was coordinated externally. See Submission step.

Peer-review

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Date	Stage	Comment	Documents/Links
May 2016	Ongoing	First meeting of the ESAC Working Group (WG) for the review of test methods in the area of serious eye damage/eye irritation (ESAC WG on Eye Irritation Test Methods)	ESAC documents_part1 ESAC documents_part2 ESAC documents_part3
Jun 2016	Ongoing	Endorsement of the WG peer review consensus report and the ESAC opinion at the 42<sup>nd</sup> ESAC plenary meeting.
Jun 2016	Finalised	ESAC Opinion on the SkinEthic™ Human Cornea Epithelium (HCE) Eye Irritation Test (EIT)	ESAC Opinion No. 2016-02

Recommendation

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Date	Stage	Comment	Documents/Links
Oct 2017	Not applicable

Regulatory acceptance/Standards

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Date	Stage	Comment	Documents/Links
Apr 2015	Revision of existing regulatory standard/guideline	Project approved and included in the OECD Test Guidelines Programme. Will be an update of OECD TG 492.
Oct 2017	Adopted/published	Updated version of OECD TG 492.	Test Guideline 492