PMID- 20974208
OWN - NLM
STAT- MEDLINE
DCOM- 20110711
LR  - 20211020
IS  - 1096-0295 (Electronic)
IS  - 0273-2300 (Print)
IS  - 0273-2300 (Linking)
VI  - 59
IP  - 1
DP  - 2011 Feb
TI  - Safety assessment of allergic contact dermatitis hazards: an analysis supporting 
      reduced animal use for the murine local lymph node assay.
PG  - 191-6
LID - 10.1016/j.yrtph.2010.10.004 [doi]
AB  - The original Organisation for Economic Co-operation and Development Test 
      Guideline 429 (OECD TG 429) for the murine local lymph node assay (LLNA) required 
      five mice/group if mice were processed individually. We used data from 83 LLNA 
      tests (275 treated groups) to determine the impact on the LLNA outcome of 
      reducing the group size from five to four. From DPM measurements, we formed all 
      possible four- and five-mice combinations for the treated and control groups. 
      Stimulation index (SI) values from each four-mice combination were compared with 
      those from five-mice combinations, and agreement (both SI<3 or both SI >/= 3) 
      determined. Average agreement between group sizes was 97.5% for the 275 treated 
      groups. Compared test-by-test, 90% (75/83) of the tests had 100% agreement; 
      agreement was 83% for the remaining eight tests. Disagreement was due primarily 
      to variability in animal responses and closeness of the SI to three (positive 
      response threshold) rather than to group size reduction. We conclude that using 
      four rather than five mice per group would reduce animal use by 20% without 
      adversely impacting LLNA performance. This analysis supported the recent update 
      to OECD TG 429 allowing a minimum of four mice/group when each mouse is processed 
      individually.
CI  - Published by Elsevier Inc.
FAU - Haseman, Joseph K
AU  - Haseman JK
AD  - J.K. Haseman Consulting, Raleigh, NC 27614, USA.
FAU - Strickland, Judy
AU  - Strickland J
FAU - Allen, David
AU  - Allen D
FAU - Salicru, Eleni
AU  - Salicru E
FAU - Paris, Michael
AU  - Paris M
FAU - Tice, Raymond R
AU  - Tice RR
FAU - Stokes, William S
AU  - Stokes WS
LA  - eng
GR  - N01ES35504/ES/NIEHS NIH HHS/United States
GR  - Z99 ES999999/Intramural NIH HHS/United States
PT  - Journal Article
DEP - 20101023
PL  - Netherlands
TA  - Regul Toxicol Pharmacol
JT  - Regulatory toxicology and pharmacology : RTP
JID - 8214983
RN  - 0 (Irritants)
SB  - IM
MH  - Animals
MH  - Dermatitis, Allergic Contact/*etiology
MH  - Dose-Response Relationship, Drug
MH  - Guidelines as Topic
MH  - Irritants/*toxicity
MH  - *Local Lymph Node Assay
MH  - Mice
MH  - Mice, Inbred CBA
MH  - Reproducibility of Results
MH  - Risk Assessment
MH  - *Sample Size
PMC - PMC3026076
MID - NIHMS253983
COIS- Conflict of Interest Statement The authors declare that there are no conflicts of 
      interest.
EDAT- 2010/10/27 06:00
MHDA- 2011/07/12 06:00
PMCR- 2012/02/01
CRDT- 2010/10/27 06:00
PHST- 2010/08/25 00:00 [received]
PHST- 2010/10/05 00:00 [revised]
PHST- 2010/10/05 00:00 [accepted]
PHST- 2010/10/27 06:00 [entrez]
PHST- 2010/10/27 06:00 [pubmed]
PHST- 2011/07/12 06:00 [medline]
PHST- 2012/02/01 00:00 [pmc-release]
AID - S0273-2300(10)00186-8 [pii]
AID - 10.1016/j.yrtph.2010.10.004 [doi]
PST - ppublish
SO  - Regul Toxicol Pharmacol. 2011 Feb;59(1):191-6. doi: 10.1016/j.yrtph.2010.10.004. 
      Epub 2010 Oct 23.