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In January 2007, the U.S. Consumer Product Safety Commission (CSPC) requested that NICEATM and
ICCVAM assess the validation status of new versions and applications of the LLNA. In response to
comments received from its
scientific advisory committee (SACATM) and from the public, ICCVAM
endorsed these activities as high priorities.
The new versions and applications being considered
include the validation status of three modified versions of the LLNA
not requiring the use of radioactive markers, and application of the LLNA for evaluating
pesticide formulations and other products. ICCVAM issued draft background review documents
(BRDs) and draft test method recommendations for these new versions and applications of the LLNA, which were
evaluated by an independent international peer review panel in 2008. The BRDs and test method
recommendations were subsequently revised to incorporate additional data, and a peer review panel
meeting to evaluate the revised documents took place in April 2009. The Panel's full report,
including all of its conclusions and recommendations, will be available in early June. ICCVAM
will consider the Panel’s report along with all public and SACATM comments received, and prepare
final test method recommendations that will be forwarded to Federal agencies for their consideration
later this year.
ICCVAM has prepared performance standards for the LLNA, which can be used to evaluate the
accuracy and reliability of new versions of the LLNA that are considered functionally and
mechanistically similar to the accepted LLNA test method. These performance standards reflect
extensive international discussions that took place during 2007 and 2008, and represent a set of
internationally harmonized standards for the conduct of the LLNA.
One of the new versions of the LLNA evaluated by NICEATM and ICCVAM in response to the CPSC
nomination was the “reduced” LLNA (rLLNA). When used to test a substance for the potential to cause
allergic contact dermatitis, the rLLNA uses fewer animals than the LLNA to provide a “yes-no” result. ICCVAM has
issued recommendations on the use of the rLLNA for this purpose.
In September 1998, NICEATM hosted a meeting of an independent peer review panel ("Panel")
to review the validity of the LLNA as an alternative test method to guinea pig tests for
assessing the allergic contact dermatitis potential of chemicals. The final report of the Panel meeting was
published in February 1999. The Panel concluded that the LLNA is a valid alternative to
currently accepted guinea pig test methods, and that the LLNA reduces the number of animals required
for testing and eliminates animal pain and distress.
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