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Click on heading links for more information and links to relevant ICCVAM documents,
Federal Register notices, and peer review information
There is a growing international need for test methods that can identify substances with the
potential to cause allergic contact dermatitis without the use of animals. Working with U.S. and
international collaborators, NICEATM and ICCVAM are evaluating the application of in vitro methods
as part of integrated decision strategies to the regulatory safety assessment of allergic contact
dermatitis hazards.
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.
View the CPSC nomination letter [PDF]
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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