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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.
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.
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 addition to the rLLNA, NICEATM and ICCVAM are conducting evaluations of other new versions and
applications of the LLNA in response to the CPSC nomination. These new versions and applications
include: the validation status of three modified LLNA test method protocols that use non-radioactive
probe chemicals; the use of the LLNA to test mixtures/formulations, aqueous solutions, and metals; and the use of
the LLNA to determine potency. ICCVAM has 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.
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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