PMID- 19733604
OWN - NLM
STAT- MEDLINE
DCOM- 20100429
LR  - 20100209
IS  - 1096-0295 (Electronic)
IS  - 0273-2300 (Linking)
VI  - 56
IP  - 1
DP  - 2010 Feb
TI  - Potency values from the local lymph node assay: application to classification, 
      labelling and risk assessment.
PG  - 54-66
LID - 10.1016/j.yrtph.2009.08.016 [doi]
AB  - Hundreds of chemicals are contact allergens but there remains a need to identify 
      and characterise accurately skin sensitising hazards. The purpose of this review 
      was fourfold. First, when using the local lymph node assay (LLNA), consider 
      whether an exposure concentration (EC3 value) lower than 100% can be defined and 
      used as a threshold criterion for classification and labelling. Second, is there 
      any reason to revise the recommendation of a previous ECETOC Task Force regarding 
      specific EC3 values used for sub-categorisation of substances based upon potency? 
      Third, what recommendations can be made regarding classification and labelling of 
      preparations under GHS? Finally, consider how to integrate LLNA data into risk 
      assessment and provide a rationale for using concentration responses and 
      corresponding no-effect concentrations. Although skin sensitising chemicals 
      having high EC3 values may represent only relatively low risks to humans, it is 
      not possible currently to define an EC3 value below 100% that would serve as an 
      appropriate threshold for classification and labelling. The conclusion drawn from 
      reviewing the use of distinct categories for characterising contact allergens was 
      that the most appropriate, science-based classification of contact allergens 
      according to potency is one in which four sub-categories are identified: 
      'extreme', 'strong', 'moderate' and 'weak'. Since draining lymph node cell 
      proliferation is related causally and quantitatively to potency, LLNA EC3 values 
      are recommended for determination of a no expected sensitisation induction level 
      that represents the first step in quantitative risk assessment.
CI  - 2009 Elsevier Inc. All rights reserved.
FAU - Loveless, S E
AU  - Loveless SE
AD  - DuPont Haskell Global Centers for Health and Environmental Sciences, Newark, DE, 
      USA. scott.e.loveless@usa.dupont.com
FAU - Api, A-M
AU  - Api AM
FAU - Crevel, R W R
AU  - Crevel RW
FAU - Debruyne, E
AU  - Debruyne E
FAU - Gamer, A
AU  - Gamer A
FAU - Jowsey, I R
AU  - Jowsey IR
FAU - Kern, P
AU  - Kern P
FAU - Kimber, I
AU  - Kimber I
FAU - Lea, L
AU  - Lea L
FAU - Lloyd, P
AU  - Lloyd P
FAU - Mehmood, Z
AU  - Mehmood Z
FAU - Steiling, W
AU  - Steiling W
FAU - Veenstra, G
AU  - Veenstra G
FAU - Woolhiser, M
AU  - Woolhiser M
FAU - Hennes, C
AU  - Hennes C
LA  - eng
PT  - Journal Article
PT  - Review
DEP - 20090904
PL  - Netherlands
TA  - Regul Toxicol Pharmacol
JT  - Regulatory toxicology and pharmacology : RTP
JID - 8214983
RN  - 0 (Allergens)
SB  - IM
MH  - Allergens/*classification
MH  - Animals
MH  - Biological Assay/methods/standards
MH  - Dermatitis, Allergic Contact/*classification/prevention & control
MH  - Disease Models, Animal
MH  - Dose-Response Relationship, Drug
MH  - Drug Labeling
MH  - Humans
MH  - *Local Lymph Node Assay
MH  - Product Labeling
MH  - Risk Assessment/*standards
MH  - Skin Tests/methods/*standards
RF  - 97
EDAT- 2009/09/08 06:00
MHDA- 2010/04/30 06:00
CRDT- 2009/09/08 06:00
PHST- 2009/07/03 00:00 [received]
PHST- 2009/08/31 00:00 [revised]
PHST- 2009/08/31 00:00 [accepted]
PHST- 2009/09/08 06:00 [entrez]
PHST- 2009/09/08 06:00 [pubmed]
PHST- 2010/04/30 06:00 [medline]
AID - S0273-2300(09)00185-8 [pii]
AID - 10.1016/j.yrtph.2009.08.016 [doi]
PST - ppublish
SO  - Regul Toxicol Pharmacol. 2010 Feb;56(1):54-66. doi: 10.1016/j.yrtph.2009.08.016. 
      Epub 2009 Sep 4.