PMID- 23279805
OWN - NLM
STAT- MEDLINE
DCOM- 20130730
LR  - 20130218
IS  - 1096-0295 (Electronic)
IS  - 0273-2300 (Linking)
VI  - 65
IP  - 2
DP  - 2013 Mar
TI  - Performance standards and alternative assays: practical insights from skin 
      sensitization.
PG  - 278-85
LID - S0273-2300(12)00256-5 [pii]
LID - 10.1016/j.yrtph.2012.12.006 [doi]
AB  - To encourage the development and validation of alternative toxicity test methods, 
      the effort required for validation of test methods proposed for regulatory 
      purposes should be minimized. Performance standards (PS) facilitate efficient 
      validation by requiring limited testing. Based on the validated method, PS define 
      accuracy and reliability values that must be met by the new similar test method. 
      The OECD adopted internationally harmonized PS for evaluating new endpoint 
      versions of the local lymph node assay (LLNA). However, in the process of 
      evaluating a lymph node cell count alternative (LNCC), simultaneous conduct of 
      the regulatory LLNA showed that this standard test may not always perform in 
      perfect accord with its own PS. The LNCC results were similar to the concurrent 
      LLNA. Discrepancies between PS, LLNA and LNCC were largely associated with 
      "borderline" substances and the variability of both endpoints. Two key lessons 
      were learned: firstly, the understandable focus on substances close to the hazard 
      classification borderline are more likely to emphasise issues of biological 
      variability, which should be taken into account during the evaluation of results; 
      secondly, variability in the results for the standard assay should be considered 
      when selecting reference chemicals for PS.
CI  - Copyright (c) 2013 Elsevier Inc. All rights reserved.
FAU - Kolle, Susanne N
AU  - Kolle SN
AD  - BASF SE, Experimental Toxicology and Ecology, Ludwigshafen, Germany. 
      susanne.kolle@basf.com
FAU - Basketter, David A
AU  - Basketter DA
FAU - Casati, Silvia
AU  - Casati S
FAU - Stokes, William S
AU  - Stokes WS
FAU - Strickland, Judy
AU  - Strickland J
FAU - van Ravenzwaay, Bennard
AU  - van Ravenzwaay B
FAU - Vohr, Hans-Werner
AU  - Vohr HW
FAU - Landsiedel, Robert
AU  - Landsiedel R
LA  - eng
GR  - N01-ES 35504/ES/NIEHS NIH HHS/United States
PT  - Comparative Study
PT  - Journal Article
PT  - Research Support, N.I.H., Extramural
PT  - Research Support, Non-U.S. Gov't
DEP - 20121229
PL  - Netherlands
TA  - Regul Toxicol Pharmacol
JT  - Regulatory toxicology and pharmacology : RTP
JID - 8214983
RN  - 0 (Allergens)
SB  - IM
MH  - Allergens/classification/*toxicity
MH  - Animal Testing Alternatives/*methods/standards
MH  - Animals
MH  - Dermatitis, Contact/*etiology/immunology/pathology
MH  - Humans
MH  - Hypersensitivity/*etiology/immunology
MH  - Local Lymph Node Assay
MH  - Reproducibility of Results
MH  - Skin Irritancy Tests
MH  - Toxicity Tests/*methods/standards
EDAT- 2013/01/03 06:00
MHDA- 2013/07/31 06:00
CRDT- 2013/01/03 06:00
PHST- 2012/10/21 00:00 [received]
PHST- 2012/12/10 00:00 [revised]
PHST- 2012/12/20 00:00 [accepted]
PHST- 2013/01/03 06:00 [entrez]
PHST- 2013/01/03 06:00 [pubmed]
PHST- 2013/07/31 06:00 [medline]
AID - S0273-2300(12)00256-5 [pii]
AID - 10.1016/j.yrtph.2012.12.006 [doi]
PST - ppublish
SO  - Regul Toxicol Pharmacol. 2013 Mar;65(2):278-85. doi: 10.1016/j.yrtph.2012.12.006. 
      Epub 2012 Dec 29.