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Annual Report for Fiscal Year 2017

Annual Report for Fiscal Year 2017
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ICCVAM International Validation Activities

The NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) and ICCVAM participate in international test method validation activities through the Organisation for Economic Co-operation and Development (OECD) and collaborate with member countries of the International Cooperation on Alternative Test Methods (ICATM), including the European Union, Japan, Korea, and Canada.

In FY 2017, ICCVAM agencies commented on draft OECD documents through the U.S. National Coordinator for the OECD Test Guidelines Programme, an ex officio ICCVAM member. NICEATM and ICCVAM collaborated with international colleagues on a revision of the acute dermal toxicity test guideline (Test Guideline 402), adopted by OECD in 2017. A NICEATM scientist also served on a peer-review panel updating Test Guideline 442B for non-radiolabeled murine local lymph node assay methods.

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

ICATM collaborations address three critical areas of cooperation: test method validation studies, independent peer review of validation studies, and development of formal recommendations on alternative testing methods. Representatives of NICEATM and ICCVAM attended an ICATM coordination meeting and ICATM-sponsored workshop to develop criteria for evaluating non-animal approaches for skin sensitization potential in October 2016.

Representatives of NICEATM and ICCVAM also attended an October 2016 workshop sponsored by ICATM. Products of this workshop include a white paper characterizing international regulatory requirements for skin sensitization testing (to be submitted for publication in FY 2018), a position paper covering workshop outcomes and ICATM recommendations (accepted for publication in FY 2018), and a proposal to develop a performance-based test guideline for defined approaches to testing and assessment of skin sensitization, which was accepted by OECD in April 2017.

Ongoing international validation studies led by ICATM member organizations that include NICEATM or ICCVAM participants are listed below.

Participation in International Validation Studies

Test Method Test Type Lead Organization* NICEATM-ICCVAM Involvement
IL-8 in vitro test for assessing skin sensitization potential Allergic contact dermatitis JaCVAM* Study is complete; an ICCVAM member served on a peer-review panel.
Vitrigel-SST assay for assessing skin sensitization potential Allergic contact dermatitis JaCVAM*
 
NICEATM staff are serving on the validation management team; study is currently on hold.  
Vitrigel-EIT assay for eye irritation testing   Ocular irritation
 
JaCVAM*
 
Study is complete; an ICCVAM member served on a peer-review panel. 
Hand1-luc in vitro test for assessing reproductive toxicity potential Reproductive toxicity  JaCVAM* Study is complete, and ICCVAM members served on a peer-review panel.
SIRC-CVS assay for eye irritation testing Ocular irritation JaCVAM* Study is complete; an ICCVAM member served on a peer-review panel.
Amino acid derivation reactivity assay Allergic contact dermatitis JaCVAM* NICEATM staff served on the validation management team; a peer review of the study is scheduled for spring 2018.

*Japanese Center for the Validation of Alternative Methods

Related Annual Report Pages:
About ICCVAM
ICCVAM Meetings
ICCVAM Test Method Evaluation Activities
Strategic Roadmap for New Approaches to Evaluate the Safety of Chemicals and Medical Products