Skin Irritation Test for the Prediction of Acute Skin Irritation of Chemicals With Sterlab RHE: 42 minutes application + 42 hours post-incubation

Topic: Skin irritation

Test Method Number:

TM2014-06 (EU)

Short Name of TM:

Sterlab RHE SIT

Year received:

2014

Responsible Organisation:

EURL ECVAM - European Union

Method Description

The present test method is designed to predict and classify the skin irritant potential of chemicals according to chemical safety regulation, using STERLAB human reconstructed epidermis (RHE) model. The protocol is established for liquids, viscous and solid test substances. The relative viability of the treated tissues is measured at the end of the treatment exposure (42 minutes) followed by a post-exposure period (42 hours) using a cell viability test.

Track Approval Status

Submission
Validation
Peer-review
Recommendation
Regulatory acceptance/Standards

Submission

Show status

Date	Stage	Comment
Oct 2014	Receipt of presubmission	Presubmission (TPF) received.
Feb 2015	Assessment of presubmission	Submitter notified of presubmission outcome. Invitation to send a full submission.
Jun 2015	Receipt of full submission	Full test submission was submitted to EURL ECVAM.
Dec 2015	Assessment of full submission	Outcome of assessment communicated to test submitter. Further clarifications requested as a follow-up of the full submission assessment.
May 2016	Assessment finalised	The test submitter provided additional information to full submission.

Validation

Peer-review

Recommendation

Regulatory acceptance/Standards