Short Time Exposure Test | EURL ECVAM

Topic: Serious eye damage/Eye irritation

Test Method Number:

TM2008-15 (US)

Short Name of TM:

STE

Year received:

2008

Responsible Organisation:

ICCVAM/NICEATM - United States

General Comments:

Method Description

The Short Time Exposure (STE) test is an in vitro test method that identifies the eye injury hazard potential of test substances applied to cultured corneal epithelial cells with cell viability used as the endpoint for quantitation of the extent of injury.

Track Approval Status

Submission
Validation
Peer-review
Recommendation
Regulatory acceptance/Standards

Submission

Show status

Date	Stage	Comment	Documents/Links
Mar 2011	Assessment finalised	ICCVAM received a Background Review Document (BRD) from Kao Corporation (Tochigi, Japan), conducted a preliminary evaluation of the BRD, and requested additional information, which resulted in several revisions with the final BRD drafted in May 2012.	Background Review Document: Current Status of In Vitro Test Methods for Identifying Ocular Irritants: Short Time Exposure (STE) test

Validation

Show status

Date	Stage	Comment	Documents/Links
Dec 2013	Finalised	ICCVAM/NICEATM prepared a Summary Review Document on the Short Time Exposure (STE) test method to evaluate performance based on test substances with corresponding in vivo data using the GHS and U.S. EPA classification systems in a top-down approach to distinguish severe eye irritants/corrosive from all other hazard categories and in a bottom-up approach to distinguish substances not labeled as eye irritants from all other hazard categories.	Short Time Exposure (STE) Test Method Summary Review Document

Peer-review

Show status

Date	Stage	Comment	Documents/Links
Dec 2013	Finalised	The National toxicology Program (NICEATM) provided the Summary Review Document (SRD) to four external reviewers who concluded that the database of substances tested was generally sufficient and the review was thorough. The final SRD includes a summary of reviewer comments.	Short Time Exposure (STE) Test Method Summary Review Document

Recommendation

Show status

Date	Stage	Comment	Documents/Links
Dec 2013	Published	In 2014, Kao Corporation included the final ICCVAM/NICEATM Summary Review Document (SRD) on a test submission package to the Organization for Economic Co-operation and Development (OECD) with comments from the ICCVAM/NICEATM Peer reviewers.	Short Time Exposure (STE) Test Method Summary Review Document

Regulatory acceptance/Standards

Show status

Date	Stage	Comment	Documents/Links
Dec 2014	Published	Kao Corporation included the ICCVAM/NICEATM STE Summary Review Document (SRD) to the OECD for consideration of the STE as an OECD Test Guideline, which was formally adopted by the OECD in 2015.	SHORT TIME EXPOSURE IN VITRO TEST METHOD FOR IDENTIFYING I) CHEMICALS INDUCING SERIOUS EYE DAMAGE AND II0 CHEMICALS NOT REQUIRING CLASSIFICATION FOR EYE IRRITATION OR SERIOUS EYE DAMAGE