PMID- 18058304
OWN - NLM
STAT- MEDLINE
DCOM- 20080317
LR  - 20091117
IS  - 1556-9535 (Electronic)
IS  - 1556-9527 (Linking)
VI  - 26
IP  - 4
DP  - 2007
TI  - The local lymph node assay: current position in the regulatory classification of 
      skin sensitizing chemicals.
PG  - 293-301
AB  - The local lymph node assay (LLNA) is being used increasingly in the 
      identification of skin sensitizing chemicals for regulatory purposes. In the 
      context of new chemicals legislation (REACH) in Europe, it is the preferred 
      assay. The rationale for this is that the LLNA quantitative and objective 
      approach to skin sensitization testing allied with the important animal welfare 
      benefits that the method offers. However, as with certain guinea pig 
      sensitization tests before it, this increasing use also brings experience with an 
      increasingly wide range of industrial and other chemicals where the outcome of 
      the assay does not always necessarily meet with the expectations of those 
      conducting it. Sometimes, the result appears to be a false negative, but rather 
      more commonly, the complaint is that the chemical represents a false positive. 
      Against this background we have here reviewed a number of instances where false 
      positive and false negative results have been described and have sought to 
      reconcile science with expectation. Based on these analyses, it is our conclusion 
      that false positives and false negatives do occur in the LLNA, as they do with 
      any other skin sensitization assay (and indeed with all tests used for hazard 
      identification), and that this occurs for a number of reasons. We further 
      conclude, however, that false positive results in the LLNA, as with the guinea 
      pig maximization test, arise most commonly via failure to distinguish what is 
      scientifically correct from that which is unpalatable. The consequences of this 
      confusion are discussed in the article, particularly in relation to the need to 
      integrate both potency measurement and risk assessments into classification and 
      labelling schemes that aim to manage potential risks to human health.
FAU - Basketter, David A
AU  - Basketter DA
AD  - St John's Institute of Dermatology, St Thomas' Hospital, London, UK. 
      david.basketter@ukonline.co.uk
FAU - Gerberick, G Frank
AU  - Gerberick GF
FAU - Kimber, Ian
AU  - Kimber I
LA  - eng
PT  - Journal Article
PL  - England
TA  - Cutan Ocul Toxicol
JT  - Cutaneous and ocular toxicology
JID - 101266892
RN  - 0 (Allergens)
SB  - IM
MH  - Allergens/*classification/*toxicity
MH  - Animals
MH  - *Dermatitis, Allergic Contact
MH  - False Negative Reactions
MH  - False Positive Reactions
MH  - Guinea Pigs
MH  - *Local Lymph Node Assay
MH  - Skin Tests/*methods/standards
EDAT- 2007/12/07 09:00
MHDA- 2008/03/18 09:00
CRDT- 2007/12/07 09:00
PHST- 2007/12/07 09:00 [pubmed]
PHST- 2008/03/18 09:00 [medline]
PHST- 2007/12/07 09:00 [entrez]
AID - 787707415 [pii]
AID - 10.1080/15569520701556647 [doi]
PST - ppublish
SO  - Cutan Ocul Toxicol. 2007;26(4):293-301. doi: 10.1080/15569520701556647.