EpiOcular™ Human Cell Construct EIT

Topic: Serious eye damage/Eye irritation

Test Method Number:

TM2008-10 (EU)

Short Name of TM:

EpiOcular EIT

Year received:

2008

Responsible Organisation:

EURL ECVAM - European Union

Protocol(s)/SOP(s):

164

Method Description

The EpiOcular™ Eye Irritation Test (EIT) consists of a reconstructed human cornea-like epithelium (RhCE) tissue construct, a non-keratinized multi-layered epithelium prepared from non-transformed, human-derived epidermal keratinocytes which show a cornea-like structure analogous to that found in in vivo. The test chemical is applied topically to a minimum of two RhCE tissue constructs. Following the exposure and post-treatment incubation periods, tissue viability is assessed by MTT assay.

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
Dec 2005	Receipt of presubmission	First submission to EURL ECVAM of a corporate validation study on the EpiOcular ET50 test method
Apr 2006	Assessment of presubmission	Assessment of the 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 for EpiOcular Eye Irritation Test (EIT) method
Sep 2008	Assessment finalised	Review of additional data of additional data provided. The method qualified to enter a prospective validation study.

Validation

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Date	Stage	Comment	Documents/Links
Dec 2008	Ongoing	First validation management meeting of the Eye Irritation Validation Study (EIVS).
Jul 2012	Ongoing	Main part of the EIVS validation study was concluded with the recommendation to optimise the EpiOcular EIT protocol for solid materials.
Sep 2013	Ongoing	Post-optimisation validation study on the EpiOcular EIT optimised solids protocol and overall results of the EIVS validation study were approved.
Mar 2014	Finalised	The EURL ECVAM - Cosmetics Europe prospective validation study of Reconstructed human Cornea-like Epithelium (RhCE)-based test methods for identifying chemicals not requiring classification and labelling for serious eye damage/eye irritation	Validation Study Report

Peer-review

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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) including the EpiOcular EIT method.
Nov 2014	Finalised	Endorsement of ESAC Opinion on the EURL ECVAM Eye Irritation Validation Study (EIVS) on EpiOcular EIT.	ESAC opinion

Recommendation

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Date	Stage	Comment	Documents/Links
Jul 2015	Not applicable

Regulatory acceptance/Standards

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Date	Stage	Comment	Documents/Links
Apr 2014	Drafting of new regulatory standard/guideline	Project approved and included in the workplan of the OECD Test guideline programme. Will be published as a new TG.
Jul 2015	Adopted/published	OECD TG492 was adopted.	OECD TG492