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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
Submission received on: October, 2014
Responsible Organisation: EURL ECVAM - European Union
Stage of Submission: Assessment Finalised
General Comments:

Further clarifications requested

Method Description

The present test method is designed to predict and classify the skin irritant potential of chemicals according to chemical safety regulation, using this human reconstructed epidermis model. 20 chemicals designed in the OECD performance standards are used for the irritation test evaluation.

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.

A cut-off value of 50% viability of the negative control value is used to classify test substances as irritant (I) or non-irritant (NI).

Cell viability is measured by dehydrogenase conversion of MTT, present in cell mitochondria, into a blue formazan salt that is quantitatively measured after extraction from tissues. The reduction of viability of tissues exposed to chemicals in comparison to negative controls is used to predict skin irritation potency. The quantitative...

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Track Approval Status

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    Regulatory acceptance/Standards
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 Regulatory acceptance/Standards