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Modified EpiDerm Skin Irritation Test for Hazard Identification and Labelling of Chemicals According to EU Classification System

Topic : Skin irritation

Test Method Number: TM2008-01 (EU)
Short Name of TM: Modified EpiDerm SIT
Year received: 2008
Responsible Organisation: EURL ECVAM - European Union '
Protocol(s)/SOP(s): 138
General Comments:

Validation finalised, OECD Test Guideline / EU Test Method available

Method Description

The Modified EpiDerm SIT is an in vitro method that has been developed and optimized to predict the skin irritation potential of chemicals according to EU classification system. The method utilizes a commercially available three-dimensional tissue construct EpiDermTM (EPI-200) produced by MatTek Corporation (US).

The test consists of a topical exposure of the neat test article to a human reconstituted epidermis model for 60 min. During the 60 minute exposure period, the treated epidermis is first left at room temperature for 25 minutes and subsequently incubated for 35 min at 37°C. At the end of exposure, the test article is removed from the epidermis and the tissue is incubated for an additional 42h to express the resulting damage. Cell viability is measured by dehydrogenase conversion of MTT [(3-4,5-dimethyl thiazole 2-yl) 2,5-diphenyltetrazoliumbromide], taken up by cell mitochondria, into a blue formazan salt that is quantitatively measured...

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Track Approval Status

  • Submission
  • Validation
  • Peer-review
  • Recommendation
  • Regulatory acceptance/Standards
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