PMID- 10654593
OWN - NLM
STAT- MEDLINE
DCOM- 20000211
LR  - 20220311
IS  - 0278-6915 (Print)
IS  - 0278-6915 (Linking)
VI  - 37
IP  - 12
DP  - 1999 Dec
TI  - Threshold for classification as a skin sensitizer in the local lymph node assay: 
      a statistical evaluation.
PG  - 1167-74
AB  - For more than 15 years, the murine local lymph node assay (LLNA) has undergone 
      development, evaluation and validation as an alternative approach to the 
      predictive identification of skin sensitizing chemicals. The criteria by which 
      sensitizing chemicals are distinguished from those without significant skin 
      sensitising hazard were developed empirically and were based on experience rather 
      than a mathematical formula or statistical method. The current practice is to 
      classify, as skin sensitizers, those chemicals which at one or more test 
      concentrations stimulate a threefold or greater increase in the proliferative 
      activity in draining lymph node cells. Despite the apparent confirmation of the 
      utility of this approach from the extensive data available, there has not 
      previously been any attempt to substantiate the accuracy of this criterion. In 
      this present investigations, data from 134 chemicals tested in the LLNA and in 
      the guinea pig and/or for which there exists clear evidence relating to human 
      skin sensitization potential, have been subjected to a rigorous statistical 
      evaluation using Receiver Operating Characteristic (ROC) curves. Whether the 
      analysis is based on a comparison with guinea pig or human data, the results 
      indicate that the empirically derived threefold threshold is an acceptable 
      practical value for hazard identification.
FAU - Basketter, D A
AU  - Basketter DA
AD  - Unilever Safety and Environmental Assurance Centre, Toxicology Unit, Sharnbrook, 
      Bedford, UK.
FAU - Lea, L J
AU  - Lea LJ
FAU - Cooper, K
AU  - Cooper K
FAU - Stocks, J
AU  - Stocks J
FAU - Dickens, A
AU  - Dickens A
FAU - Pate, I
AU  - Pate I
FAU - Dearman, R J
AU  - Dearman RJ
FAU - Kimber, I
AU  - Kimber I
LA  - eng
PT  - Journal Article
PL  - England
TA  - Food Chem Toxicol
JT  - Food and chemical toxicology : an international journal published for the British 
      Industrial Biological Research Association
JID - 8207483
RN  - 0 (Irritants)
SB  - IM
MH  - Animal Testing Alternatives
MH  - Animals
MH  - Evaluation Studies as Topic
MH  - Irritants/*toxicity
MH  - *Lymph Nodes
MH  - Mice
MH  - Skin/*drug effects
MH  - Toxicity Tests/*methods
EDAT- 2000/02/02 09:00
MHDA- 2000/02/19 09:00
CRDT- 2000/02/02 09:00
PHST- 2000/02/02 09:00 [pubmed]
PHST- 2000/02/19 09:00 [medline]
PHST- 2000/02/02 09:00 [entrez]
AID - S027869159900112X [pii]
AID - 10.1016/s0278-6915(99)00112-x [doi]
PST - ppublish
SO  - Food Chem Toxicol. 1999 Dec;37(12):1167-74. doi: 10.1016/s0278-6915(99)00112-x.