PMID- 23459101
OWN - NLM
STAT- MEDLINE
DCOM- 20131118
LR  - 20130506
IS  - 1096-0295 (Electronic)
IS  - 0273-2300 (Linking)
VI  - 66
IP  - 1
DP  - 2013 Jun
TI  - Evaluation of the performance of the reduced local lymph node assay for skin 
      sensitization testing.
PG  - 66-71
LID - S0273-2300(13)00024-X [pii]
LID - 10.1016/j.yrtph.2013.02.006 [doi]
AB  - The local lymph node assay (LLNA) is the preferred method for classification of 
      sensitizers within REACH. To reduce the number of mice for the identification of 
      sensitizers the reduced LLNA was proposed, which uses only the high dose group of 
      the LLNA. To evaluate the performance of this method for classification, LLNA 
      data from REACH registrations were used and classification based on all dose 
      groups was compared to classification based on the high dose group. We confirmed 
      previous examinations of the reduced LLNA showing that this method is less 
      sensitive compared to the LLNA. The reduced LLNA misclassified 3.3% of the 
      sensitizers identified in the LLNA and misclassification occurred in all potency 
      classes and that there was no clear association with irritant properties. It is 
      therefore not possible to predict beforehand which substances might be 
      misclassified. Another limitation of the reduced LLNA is that skin sensitizing 
      potency cannot be assessed. For these reasons, it is not recommended to use the 
      reduced LLNA as a stand-alone assay for skin sensitization testing within REACH. 
      In the future, the reduced LLNA might be of added value in a weight of evidence 
      approach to confirm negative results obtained with non-animal approaches.
CI  - Copyright (c) 2013 Elsevier Inc. All rights reserved.
FAU - Ezendam, Janine
AU  - Ezendam J
AD  - National Institute for Public Health and the Environment (RIVM), P.O. Box 1, 
      NL-3720BA Bilthoven, The Netherlands. Janine.Ezendam@rivm.nl
FAU - Muller, Andre
AU  - Muller A
FAU - Hakkert, Betty C
AU  - Hakkert BC
FAU - van Loveren, Henk
AU  - van Loveren H
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20130228
PL  - Netherlands
TA  - Regul Toxicol Pharmacol
JT  - Regulatory toxicology and pharmacology : RTP
JID - 8214983
RN  - 0 (Irritants)
SB  - IM
MH  - Animals
MH  - Databases, Factual
MH  - Dose-Response Relationship, Drug
MH  - Irritants/administration & dosage/classification/*toxicity
MH  - *Local Lymph Node Assay
MH  - Mice
MH  - Skin/*drug effects/pathology
EDAT- 2013/03/06 06:00
MHDA- 2013/11/19 06:00
CRDT- 2013/03/06 06:00
PHST- 2012/12/10 00:00 [received]
PHST- 2013/02/10 00:00 [revised]
PHST- 2013/02/12 00:00 [accepted]
PHST- 2013/03/06 06:00 [entrez]
PHST- 2013/03/06 06:00 [pubmed]
PHST- 2013/11/19 06:00 [medline]
AID - S0273-2300(13)00024-X [pii]
AID - 10.1016/j.yrtph.2013.02.006 [doi]
PST - ppublish
SO  - Regul Toxicol Pharmacol. 2013 Jun;66(1):66-71. doi: 10.1016/j.yrtph.2013.02.006. 
      Epub 2013 Feb 28.