Validation Status of the Murine Local Lymph Node Assay (LLNA) for the Assessment of the Contact Dermatitis
Potential of Chemicals and Products
March 4-6, 2008
U.S. Consumer Products Safety Commission Headquarters
Bethesda, MD
Over 50 people from five countries, representing government, industry, animal welfare interests and
international organizations, attended this peer review panel meeting. The Panel, which included
experts in the field of dermatology, toxicology, biostatistics, regulatory policy, immunology and
veterinary medicine, evaluated the broader use of the LLNA for regulatory testing. Topics considered
included:
- The LLNA as a stand-alone assay for potency determination for hazard classification purposes
- Modified LLNA protocols that do not require the use of radioactively labeled reagents
- The LLNA limit dose procedure
- The use of the LLNA to test mixtures, aqueous solutions, and metals (applicability domain for the LLNA)
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View Meeting Agenda
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The Panel also evaluated revised draft performance standards for the LLNA.
Please see below for a link to the revised draft performance standards and draft Background Review Documents.
A report of the peer panel meeting is in preparation and is expected to be available by May 2008 on the NICEATM-ICCVAM website.
ICCVAM Recommendations on the evaluated methods are expected to be available by fall 2008.
View Federal Register Notice announcing the meeting
(Vol. 73, No. 5, pp. 1360-1362, January 8, 2008)
More information about the LLNA evaluation
Documents reviewed at the meeting
View comments received in response to the meeting announcement and to the draft documents
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