PMID- 17658676
OWN - NLM
STAT- MEDLINE
DCOM- 20071031
LR  - 20161124
IS  - 0300-483X (Print)
IS  - 0300-483X (Linking)
VI  - 238
IP  - 2-3
DP  - 2007 Sep 5
TI  - The murine local lymph node assay: regulatory and potency considerations under 
      REACH.
PG  - 71-89
AB  - From June 2007, new chemicals legislation on the registration, evaluation, 
      authorization and restriction of chemicals (REACH) will come into force across 
      the European Union. This will require the submission of data on human health 
      effects of chemicals, including chemical safety assessments which will require 
      measurements of potency. For skin sensitization hazard identification, REACH 
      states that the first-choice in vivo assay is the local lymph node assay (LLNA). 
      This test has also been the UK competent authority's preferred test for skin 
      sensitization since 2002, and has now replaced guinea pig tests in dossiers 
      submitted to it under the Notification of New Substances Regulations. Advantages 
      of the LLNA over guinea pig tests include improvements in animal welfare, a more 
      scientific approach to hazard identification, and the inclusion of a 
      dose-response element in the endpoint, which enables an estimation of potency. 
      However, notifiers to the UK competent authority have sometimes been reluctant to 
      use the assay because of concerns over false-positive reactions. Across Europe, 
      these concerns have been heightened in the lead-up to the introduction of REACH, 
      since the use of in vivo alternatives to the LLNA will require scientific 
      justification. This review will address some of these concerns from a regulatory 
      perspective.
FAU - McGarry, Helen F
AU  - McGarry HF
AD  - Corporate Health Specialist Division 1, Health and Safety Executive, Redgrave 
      Court 2.3, Merton Road, Bootle, Merseyside L20 7HS, UK. 
      helen.mcgarry@hse.gsi.gov.uk
LA  - eng
PT  - Journal Article
PT  - Review
DEP - 20070614
PL  - Ireland
TA  - Toxicology
JT  - Toxicology
JID - 0361055
RN  - 0 (Hazardous Substances)
SB  - IM
MH  - Animals
MH  - Dermatitis, Allergic Contact/diagnosis/etiology
MH  - Dose-Response Relationship, Drug
MH  - European Union
MH  - Hazardous Substances/*analysis/toxicity
MH  - *Local Lymph Node Assay
MH  - Mice
MH  - Toxicology/legislation & jurisprudence/methods
MH  - United Kingdom
RF  - 125
EDAT- 2007/07/31 09:00
MHDA- 2007/11/01 09:00
CRDT- 2007/07/31 09:00
PHST- 2007/05/15 00:00 [received]
PHST- 2007/06/07 00:00 [revised]
PHST- 2007/06/11 00:00 [accepted]
PHST- 2007/07/31 09:00 [pubmed]
PHST- 2007/11/01 09:00 [medline]
PHST- 2007/07/31 09:00 [entrez]
AID - S0300-483X(07)00326-5 [pii]
AID - 10.1016/j.tox.2007.06.002 [doi]
PST - ppublish
SO  - Toxicology. 2007 Sep 5;238(2-3):71-89. doi: 10.1016/j.tox.2007.06.002. Epub 2007 
      Jun 14.