PMID- 11754529
OWN - NLM
STAT- MEDLINE
DCOM- 20020426
LR  - 20220311
IS  - 0273-2300 (Print)
IS  - 0273-2300 (Linking)
VI  - 34
IP  - 3
DP  - 2001 Dec
TI  - ICCVAM evaluation of the murine local lymph node assay. The ICCVAM review 
      process.
PG  - 249-57
AB  - New test methods are being developed to improve the prediction of human and 
      environmental risks and to benefit animal welfare by reducing, refining, and 
      replacing animal use. Regulatory adoption of new test methods is often a complex 
      and protracted process, requiring test method validation, regulatory acceptance, 
      and implementation. Assessments of new test methods have not always been uniform 
      within or among regulatory agencies. Thus, there have been increased pressures 
      for a harmonized approach to test method evaluation and acceptance. In 1997, in 
      response to these pressures and to U.S. Public Law 103-43, the National Institute 
      of Environmental Health Sciences (NIEHS) established the Interagency Coordinating 
      Committee on the Validation of Alternative Methods (ICCVAM) to coordinate 
      interagency consideration of new and revised test methods. This article describes 
      the validation and acceptance criteria and process used for the first test method 
      evaluated by ICCVAM, the murine local lymph node assay (LLNA). Based on ICCVAM's 
      conclusions and recommendations, the LLNA has been accepted by U.S. regulatory 
      agencies as a stand-alone assay for allergic contact dermatitis. Two related 
      articles in this series of three present the results of the independent peer 
      review evaluation of the LLNA and summarize the performance characteristics of 
      the database substantiating the validity of the LLNA.
FAU - Sailstad, D M
AU  - Sailstad DM
AD  - Office of Research and Development, National Health and Environmental Effects 
      Research Laboratory, Experimental Toxicology Division, U.S. EPA, MD 92, Research 
      Triangle Park, NC 27711, USA.
FAU - Hattan, D
AU  - Hattan D
FAU - Hill, R N
AU  - Hill RN
FAU - Stokes, W S
AU  - Stokes WS
LA  - eng
PT  - Journal Article
PL  - Netherlands
TA  - Regul Toxicol Pharmacol
JT  - Regulatory toxicology and pharmacology : RTP
JID - 8214983
SB  - IM
MH  - Animal Welfare
MH  - Animals
MH  - Dermatitis, Allergic Contact/diagnosis/*etiology
MH  - Environmental Exposure/standards
MH  - Government Agencies/standards
MH  - Guidelines as Topic/standards
MH  - *Interinstitutional Relations
MH  - *Local Lymph Node Assay
MH  - Mice
MH  - National Institutes of Health (U.S.)/standards
MH  - Peer Review/methods/standards
MH  - Reproducibility of Results
MH  - Risk Assessment
MH  - Toxicity Tests/methods/*standards
MH  - United States
MH  - United States Environmental Protection Agency/standards
MH  - United States Food and Drug Administration/standards
MH  - United States Occupational Safety and Health Administration/standards
EDAT- 2002/01/05 10:00
MHDA- 2002/04/27 10:01
CRDT- 2002/01/05 10:00
PHST- 2002/01/05 10:00 [pubmed]
PHST- 2002/04/27 10:01 [medline]
PHST- 2002/01/05 10:00 [entrez]
AID - S0273230001914965 [pii]
AID - 10.1006/rtph.2001.1496 [doi]
PST - ppublish
SO  - Regul Toxicol Pharmacol. 2001 Dec;34(3):249-57. doi: 10.1006/rtph.2001.1496.