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Annual Report for Fiscal Year 2016

Annual Report for Fiscal Year 2016
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ICCVAM International Validation Activities

NICEATM and ICCVAM participate in international test method validation activities through the Organisation for Economic Co-operation and Development (OECD), and collaborate with countries that are members of the International Cooperation on Alternative Test Methods (ICTAM), including the European Union, Japan, Korea, and Health Canada.

In FY 2016, ICCVAM agencies commented on draft OECD documents through the U.S. National Coordinator for the OECD Test Guidelines Programme, an ex officio ICCVAM member. In FY 2016, NICEATM and ICCVAM collaborated with international colleagues on the following OECD activities:

  • Drafted a new proposal for a performance based test guideline regarding defined skin sensitization approaches and test methods to be submitted to OECD in FY 2017.
  • Revised the acute dermal toxicity test guideline.
  • Drafted a guidance document on integrated approaches to testing and assessment (IATAs) for eye irritation hazard potential.
  • Drafted a guidance document on the reporting of defined approaches to be used within IATAs.
  • Contributed a case study to a guidance document on IATAs for skin sensitization.

Representatives of NICEATM and ICCVAM will attend meetings of the OECD expert groups on eye irritation and skin sensitization in FY 2017.

International Cooperation on Alternative Test Methods collaborations address three critical areas of cooperation: test method validation studies, independent peer review of validation studies, and the development of formal recommendations on alternative testing methods. Representatives of NICEATM and ICCVAM attended an ICATM coordination meeting in November 2015. A NICEATM scientist served as a liaison member to a European Union Reference Laboratory for Alternatives to Animal Testing Scientific Advisory Committee working group that reviewed the relevance and predictive capacity of two in vitro eye irritation test methods. Representatives of NICEATM and ICCVAM will attend the FY 2017 workshop sponsored by ICATM to develop criteria for evaluating non-animal approaches for skin sensitization potential.

The table below lists ongoing international validation studies led by ICATM member organizations that include NICEATM or ICCVAM participants.

Participation in International Validation Studies

Test Method Type of Test Lead Organization NICEATM-ICCVAM Involvement
IL-8 in vitro test for assessing skin sensitization potential
 
Allergic contact dermatitis JaCVAM* NICEATM staff served on the validation management team and provided comments on study design, chemical selection, and test method protocols.
Vitrigel-SST assay for assessing skin sensitization potential
 
Allergic contact dermatitis JaCVAM*
 
NICEATM staff served on the validation management team.
 
Vitrigel-EIT assay for eye irritation testing
 
Ocular irritation
 
JaCVAM*
 
NICEATM staff served on the validation management team.
 
Hand1-luc in vitro test for assessing reproductive toxicity potential Reproductive toxicity
 
JaCVAM* NICEATM staff served on the validation management team.
 
SIRC-CVS assay for eye irritation testing Ocular irritation JaCVAM* NICEATM staff served on the validation management team.
Amino acid derivation reactivity assay Allergic contact dermatitis JaCVAM* NICEATM staff served on the validation management team.

*Japanese Center for the Validation of Alternative Methods

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