PMID- 19514920
OWN - NLM
STAT- MEDLINE
DCOM- 20091027
LR  - 20091117
IS  - 1556-9535 (Electronic)
IS  - 1556-9527 (Linking)
VI  - 28
IP  - 1
DP  - 2009
TI  - The impact of LLNA group size on the identification and potency classification of 
      skin sensitizers: a review of published data.
PG  - 19-22
LID - 10.1080/15569520802636280 [doi]
AB  - The Organisation for Economic Co-operation and Development (OECD) Test Guideline 
      429 for the local lymph node assay (LLNA) indicates a minimum of 4 mice per dose 
      group, or of 5 mice if statistics are required. Recent discussions at the 
      Interagency Coordinating Committee for the Validation of Alternative Methods 
      (ICCVAM) have led to suggestions that there should be a change to LLNA protocol 
      requirements to mandate a minimum of 5 mice per group. Although it is not certain 
      that any such proposal will be made, the debate is an important one and prompts 
      reconsideration of animal requirements in the LLNA. In this paper we have 
      conducted an analysis of published data from our own laboratories to determine 
      whether the use of 4 or of 5 mice has had any practical impact on the outcome of 
      the assay. Of the data sets for 17 chemicals in the 4-animal assay (14 positive, 
      1 uncertain, and 2 negative), 16 results were identical in the 5-animal assay. A 
      marginally positive result in the 4-animal assay was negative in the 5-animal 
      assay. Where potency determinations were made, the outcomes were essentially 
      identical in the 2 forms of the LLNA. Consequently, it is concluded that there is 
      no scientific justification for removing the option to use a 4-animal version of 
      the LLNA.
FAU - Basketter, David A
AU  - Basketter DA
AD  - DABMEB Consultancy Ltd, Sharnbrook, UK. david.basketter@ukonline.co.uk
FAU - Dearman, Rebecca J
AU  - Dearman RJ
FAU - Kimber, Ian
AU  - Kimber I
FAU - Gerberick, G Frank
AU  - Gerberick GF
FAU - Ryan, Cindy A
AU  - Ryan CA
LA  - eng
PT  - Journal Article
PT  - Review
PL  - England
TA  - Cutan Ocul Toxicol
JT  - Cutaneous and ocular toxicology
JID - 101266892
SB  - IM
MH  - Animals
MH  - *Local Lymph Node Assay
MH  - Mice
MH  - Sample Size
RF  - 21
EDAT- 2009/06/12 09:00
MHDA- 2009/10/29 06:00
CRDT- 2009/06/12 09:00
PHST- 2009/06/12 09:00 [entrez]
PHST- 2009/06/12 09:00 [pubmed]
PHST- 2009/10/29 06:00 [medline]
AID - 10.1080/15569520802636280 [doi]
PST - ppublish
SO  - Cutan Ocul Toxicol. 2009;28(1):19-22. doi: 10.1080/15569520802636280.