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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.
View Federal Register notice announcing receipt of agency responses to recommendations (76 FR 2388, January 13, 2011)
[PDF]
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
View publications and presentations on NICEATM-ICCVAM evaluations of the murine local
lymph node assay for identification and classification of sensitizers
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 are available below; agency responses will be posted as they are received.
- National Institutes of Environmental Health Sciences (NIEHS)
- Letter from Linda Birnbaum, Ph.D., DABT, ATS, Director, NIEHS, to the ICCVAM Committee (December 7, 2010)
[PDF]
- Agency for Toxic Substances and Disease Registry (ATSDR)
- Letter from Dr. Birnbaum to Thomas R. Frieden, M.D., M.P.H., Administrator, ATSDR
[PDF]
- Response from Dr. Frieden (received January 4, 2011) [PDF]
- Consumer Product Safety Commission (CPSC)
- Letter from Dr. Birnbaum to Inez Moore Tenenbaum, Chairman, CPSC [PDF]
- Response from Todd Stevenson, Office of the Secretary (received February 3, 2011) [PDF]
- Environmental Protection Agency (EPA)
- Letter from Dr. Birnbaum to Lisa P. Jackson, Administrator, EPA [PDF]
- Response from John Fowle, Ph.D., DABT, Office of Pesticide Programs (received December 17, 2010) [PDF]
- Food and Drug Administration (FDA)
- Letter from Dr. Birnbaum to Margaret Hamburg, M.D., Commissioner [PDF]
- Response from Jesse L. Goodman, M.D., M.P.H. , Chief Scientist and Deputy Commissioner for
Science and Public Health (received January 13, 2011) [PDF]
- National Cancer Institute (NCI)
- Letter from Dr. Birnbaum to John E. Niederhuber, M.D., Director, NCI [PDF]
- Response from Sandy Koeneman, Director, NCI Information Liaison Office (received October 26, 2010) [PDF]
- National Institutes of Health (NIH)
- Letter from Dr. Birnbaum to Francis S. Collins, M.D., Ph.D., Director, NIH [PDF]
- Response from Dr. Collins (received November 23, 2010) [PDF]
- National Institute for Occupational Safety and Health (NIOSH)
- Letter from Dr. Birnbaum to John Howard, M.D., Director, NIOSH [PDF]
- Response from Dr. Howard (received February 11, 2011) [PDF]
- National Library of Medicine (NLM)
- Letter from Dr. Birnbaum to Donald A.B. Lindberg, M.D., Director, NLM [PDF]
- Response from Dr. Lindberg (received January 13, 2011) [PDF]
- Occupational Safety and Health Administration (OSHA)
- Letter from Dr. Birnbaum to David Michaels, Ph.D., M.P.H., Assistant Secretary of Labor for Occupational Safety and Health,
OSHA [PDF]
- Response from Dr. Michaels (received November 16, 2010) [PDF]
- U.S. Department of Agriculture
- Letter from Dr. Birnbaum to Tom Vilsack, Secretary of Agriculture [PDF]
- Response from Jose R. Diez, Associate Deputy Administrator, Animal and Plant Health Inspection Service (received June 28, 2010) [PDF]
- U.S. Department of Defense
- Letter from Dr. Birnbaum to Robert M. Gates, Ph.D., Secretary of Defense [PDF]
- Response from David Honey, PhD, Director, Research Directorate (received November 8, 2010) [PDF]
- U.S. Department of Energy
- Letter from Dr. Birnbaum to Steven Chu, Secretary of Energy [PDF]
- Response from Michael Kuperberg, Ph.D., Office of Biological and Environmental Research (received December 6, 2010) [PDF]
- U.S. Department of the Interior
- Letter from Dr. Birnbaum to Ken Salazar, Secretary of the Interior [PDF]
- Response from William Werkhiser, Regional Director, Eastern Region, U.S. Geological Survey (received August 21, 2010) [PDF]
- U.S. Department of Transportation
- Letter from Dr. Birnbaum to Ray LaHood, Secretary of Transportation [PDF]
- Response from Cynthia Quarterman, Pipeline and Hazardous Material Safety Administration (received December 26, 2010) [PDF]
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