Human Reconstructed Corneal Epithelium (HCE) Eye Irritation test

Topic: Serious eye damage/Eye irritation

Test Method Number:

TM2008-09 (EU)

Short Name of TM:

SkinEthic HCE

Year received:

2008

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).

Succeeding TM:

TM2015-03 - SkinEthic™ HCE Eye Irritation Test

Method Description

The purpose of this assay was to evaluate the ocular irritation potential of chemicals for European Union labelling and classification, in order to discriminate non irritants from irritants, and to be used as an alternative to the traditional in vivo rabbit eye test method (OECD TG 405). The test uses the SkinEthic™ HCE model, a reconstructed human cornea-like epithelium (RhCE) consisting of a multilayered epithelium prepared from immortalized human corneal epithelial cell. It constitutes a three dimensional structure which reproduces the multi-layer organization of the human cornea. The test consists of a topical exposure of the neat test chemicals onto the Human Corneal Epithelium model HCE, followed by cell viability measurement.

Track Approval Status

Submission
Validation
Peer-review
Recommendation
Regulatory acceptance/Standards

Submission

Show status

Date	Stage	Comment
Jan 1970	Assessment of full submission
Dec 2005	Receipt of presubmission	First submission to EURL ECVAM of a corporate pre-validation study on the SkinEthic<sup>TM</sup> HCE test method.
Apr 2006	Assessment of presubmission	Assessment of the full test submission and request to enlarge the scope to further chemicals
Apr 2008	Receipt of full submission	Updated submission to EURL ECVAM including optimisation and pre-validation of the method.
Jun 2008	Assessment of full submission	Assessment of submission was conducted by EURL ECVAM with request of further clarifications.
Sep 2008	Receipt of revised full submission	Updated submission to EURL ECVAM.
Oct 2008	Assessment finalised	The method qualified to enter a prospective validation study.

Validation

Show status

Date	Stage	Comment	Documents/Links
Dec 2008	Ongoing	First validation management meeting of the ECVAM/COLIPA retrospective Eye Irritation Validation Study (EIVS).
Jul 2012	Ongoing	Main part of the EIVS validation study was concluded with the recommendation to optimise the SkinEthic<sup>TM</sup> protocols.
Mar 2013	Finalised	Approval of the final conclusions on validation study and recommendations on SkinEthic<sup>TM</sup>HCE. The method was unable to comply fully with the acceptance criteria set by the validation management group.	Validation report

Peer-review

Show status

Date	Stage	Comment	Documents/Links
Mar 2014	Ongoing	First meeting of the ESAC Working Group (WG) to draft the WG Peer Review Consensus Report on the ECVAM coordinated Eye Irritation Validation Study (EIVS)	ESAC documents
Nov 2014	Finalised	Endorsement of ESAC Opinion on the prospective Eye Irritation Validation Study (EIVS) at 40th ESAC plenary meeting. Recommendation of optimising SkinEthic<sup>TM</sup>HCE protocols for liquid and solid chemicals	ESAC opinion

Recommendation

Regulatory acceptance/Standards