PMID- 19523501
OWN - NLM
STAT- MEDLINE
DCOM- 20091207
LR  - 20090831
IS  - 1096-0295 (Electronic)
IS  - 0273-2300 (Linking)
VI  - 55
IP  - 1
DP  - 2009 Oct
TI  - Application of a weight of evidence approach to assessing discordant 
      sensitisation datasets: implications for REACH.
PG  - 90-6
LID - 10.1016/j.yrtph.2009.06.005 [doi]
AB  - The local lymph node assay (LLNA) is the assay of choice in European regulatory 
      toxicology. As with other toxicology/sensitisation assays, it has a potential for 
      false results, the anionic surfactant sodium lauryl sulphate (SLS) representing a 
      classic example. In the work reported here, examples of false positives in the 
      LLNA are compared to published "benchmarks" such as SLS. Clear false positives 
      (e.g. oleic acid) are also contrasted with examples where data interpretation is 
      more challenging. As the LLNA will be applicable to >30,000 chemicals under 
      REACH, and in the light of animal welfare considerations to do no more than the 
      absolute minimum of animal testing, results from a single LLNA often represent 
      the only available data on sensitisation. This reinforces the need to ensure data 
      from this assay are interpreted intelligently, using scientific analysis of 
      results and considering the weight of evidence, before decisions are made on 
      which substances should be classified as representing a skin sensitisation 
      hazard. In chemical classes where the LLNA has been shown to be an inappropriate 
      assay other standardised methods (e.g. the Buehler or Magnusson and Kligman 
      guinea pig tests [OECD 406]) should be employed as the first choice assays.
FAU - Basketter, David
AU  - Basketter D
AD  - DABMEB Consultancy Ltd, Sharnbrook, Bedford MK44 1PR, UK. 
      david.basketter@ukonline.co.uk
FAU - Ball, Nicholas
AU  - Ball N
FAU - Cagen, Stuart
AU  - Cagen S
FAU - Carrillo, Juan-Carlos
AU  - Carrillo JC
FAU - Certa, Hans
AU  - Certa H
FAU - Eigler, Dorothea
AU  - Eigler D
FAU - Garcia, Christine
AU  - Garcia C
FAU - Esch, Harald
AU  - Esch H
FAU - Graham, Cynthia
AU  - Graham C
FAU - Haux, Carl
AU  - Haux C
FAU - Kreiling, Reinhard
AU  - Kreiling R
FAU - Mehling, Annette
AU  - Mehling A
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20090610
PL  - Netherlands
TA  - Regul Toxicol Pharmacol
JT  - Regulatory toxicology and pharmacology : RTP
JID - 8214983
RN  - 0 (Allergens)
RN  - 0 (Hazardous Substances)
SB  - IM
MH  - Allergens/*toxicity
MH  - Data Interpretation, Statistical
MH  - Environmental Exposure
MH  - False Negative Reactions
MH  - False Positive Reactions
MH  - Hazardous Substances/*toxicity
MH  - Humans
MH  - *Local Lymph Node Assay
MH  - Risk Assessment/*methods
MH  - Skin/drug effects
MH  - Toxicity Tests/*methods/standards
EDAT- 2009/06/16 09:00
MHDA- 2009/12/16 06:00
CRDT- 2009/06/16 09:00
PHST- 2009/04/24 00:00 [received]
PHST- 2009/06/04 00:00 [revised]
PHST- 2009/06/05 00:00 [accepted]
PHST- 2009/06/16 09:00 [entrez]
PHST- 2009/06/16 09:00 [pubmed]
PHST- 2009/12/16 06:00 [medline]
AID - S0273-2300(09)00108-1 [pii]
AID - 10.1016/j.yrtph.2009.06.005 [doi]
PST - ppublish
SO  - Regul Toxicol Pharmacol. 2009 Oct;55(1):90-6. doi: 10.1016/j.yrtph.2009.06.005. 
      Epub 2009 Jun 10.