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ICCVAM Participation in Development of OECD Test Guidelines for the Detection of Dermal Irritants
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A validated test method can achieve acceptance on the international level when it is included in a test guideline developed by the Organisation for Economic Co-operation and Development (OECD). OECD test guidelines are currently under development for the use of in vitro human skin model systems such as EPISKIN™ and EpiDerm™ in identification of substances with the potential to cause skin irritation. ICCVAM and its Dermal Corrosivity and Irritation Working Group are participating in the development of these test guidelines.

Relevant Documents

  • Draft OECD Test Guideline: In Vitro Skin Irritation: Human Skin Model Test
    Draft: December 2009 [PDF]
    Draft: December 2007 [PDF]
    Additional validation documents:
    • Eskes et al. The ECVAM (European Committee on the Validation of Alternative Methods) International Validation Study on In Vitro Tests for Acute Skin Irritation: Selection of Test Chemicals. ATLA 35:603-619 (2007) [PDF]
    • Spielmann et al. The ECVAM International Validation Study on In Vitro Tests for Acute Skin Irritation: Report on the Validity of the EPISKIN and EpiDerm Assays and on the Skin Integrity Function Test ATLA 35:559–601 (2007) [PDF]
    • Summary Report of the ECVAM Skin Irritation Validation Study (SIVS) (October 2006) [PDF]
    • Report From the Chemicals Selection Subcommittee to the Management Team on Potential Reasons for the Misclassification Of Chemicals in the EPISKIN and EpiDerm Assays [PDF]
    • SIVS Phase II: Analysis of the primary endpoint MTT and the secondary endpoint IL1-α — Report from the study biostatistician to the management team [PDF]
    • Performance Standards for Applying Human Skin Models to In Vitro Skin Irritation Testing (May 2007) [PDF]
    • SIVS Phase I: Interim Analysis [PDF]
  • August 2008 letter to Dr. Jerry Smrchek, U.S. National Coordinator for the OECD Test Guidelines Program, regarding ICCVAM comments on the December 2007 draft Test Guideline [PDF]
  • ICCVAM Comments on the December 2007 draft Test Guideline [PDF]
  • Statement of the ECVAM Scientific Advisory Committee (ESAC) on the Validity of In Vitro Tests for Skin Irritation [PDF]
    View ESAC Statements on the ECVAM website - Select "Validated Methods"
  • ECVAM Peer Review Panel Report [PDF]
    View ECVAM Reports on the ECVAM website - Select "Download Study Documents"
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