Recommendations to Federal Agencies on the LLNA and Agency Responses
See below for letters communicating the ICCVAM recommendations to member agencies and
for ICCVAM member agency responses
The murine local lymph node assay (LLNA) is a test method for assessing the hazard
potential of a test substance to induce allergic contact dermatitis. Following its
original evaluation of the LLNA in 1999,
ICCVAM recommended the LLNA as
a valid stand-alone alternative to traditionally accepted guinea pig test methods for assessing the allergic contact
dermatitis hazard potential of a substance, in most testing situations. 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. These included evaluations of the use of the LLNA for
evaluating pesticide formulations, metals, substances in aqueous solutions, and other products, and of three modified versions of the LLNA not
requiring the use of radioactive markers.
The ICCVAM evaluation of these new versions and applications of the LLNA is now complete, and
ICCVAM has made recommendations to Federal agencies.
- Based on a comprehensive technical evaluation of their scientific validity, ICCVAM concluded
that two of the nonradioactive LLNA methods, the LLNA: DA and the LLNA: BrdU-ELISA, can be
used to identify substances that may cause allergic skin reactions.
- ICCVAM also recommends that the LLNA may be used to test most chemicals
and products for their potential to cause allergic contact dermatitis.
The links below lead to pages containing more details about the ICCVAM recommendations and other information about the ICCVAM evaluations.
ICCVAM Evaluation of the Applicability Domain for the Murine Local Lymph Node Assay
ICCVAM Evaluation of Nonradioactive Versions of the Murine Local Lymph Node Assay
Transmittal of Recommendations to Federal Agencies and Agency Responses
The ICCVAM recommendations on the use of these new versions and applications of the LLNA
were communicated to Federal agencies in letters from Dr. Linda Birnbaum, Director, NIEHS.
These letters and the responses from ICCVAM member Federal agencies are posted below.
- National Institutes of Environmental Health Sciences (NIEHS)
- Agency for Toxic Substances and Disease Registry (ATSDR)
- Consumer Product Safety Commission (CPSC)
- Environmental Protection Agency (EPA)
- Food and Drug Administration (FDA)
- National Cancer Institute (NCI)
- National Institutes of Health (NIH)
- National Institute for Occupational Safety and Health (NIOSH)
- National Library of Medicine (NLM)
- Occupational Safety and Health Administration (OSHA)
- U.S. Department of Agriculture
- U.S. Department of Defense
- U.S. Department of Energy
- U.S. Department of the Interior
- U.S. Department of Transportation