PMID- 25541156
OWN - NLM
STAT- MEDLINE
DCOM- 20160122
LR  - 20220311
IS  - 1096-0295 (Electronic)
IS  - 0273-2300 (Linking)
VI  - 71
IP  - 2
DP  - 2015 Mar
TI  - Assessing skin sensitization hazard in mice and men using non-animal test 
      methods.
PG  - 337-51
LID - S0273-2300(14)00309-2 [pii]
LID - 10.1016/j.yrtph.2014.12.008 [doi]
AB  - Sensitization, the prerequisite event in the development of allergic contact 
      dermatitis, is a key parameter in both hazard and risk assessments. The pathways 
      involved have recently been formally described in the OECD adverse outcome 
      pathway (AOP) for skin sensitization. One single non-animal test method will not 
      be sufficient to fully address this AOP and in many cases the use of a battery of 
      tests will be necessary. A number of methods are now fully developed and 
      validated. In order to facilitate acceptance of these methods by both the 
      regulatory and scientific communities, results of the single test methods (DPRA, 
      KeratinoSens, LuSens, h-CLAT, (m)MUSST) as well for a the simple '2 out of 3' ITS 
      for 213 substances have been compiled and qualitatively compared to both animal 
      and human data. The dataset was also used to define different mechanistic domains 
      by probable protein-binding mechanisms. In general, the non-animal test methods 
      exhibited good predictivities when compared to local lymph node assay (LLNA) data 
      and even better predictivities when compared to human data. The '2 out of 3' 
      prediction model achieved accuracies of 90% or 79% when compared to human or LLNA 
      data, respectively and thereby even slightly exceeded that of the LLNA.
CI  - Copyright (c) 2014 The Authors. Published by Elsevier Inc. All rights reserved.
FAU - Urbisch, Daniel
AU  - Urbisch D
AD  - BASF SE, Experimental Toxicology and Ecology, Ludwigshafen, Germany.
FAU - Mehling, Annette
AU  - Mehling A
AD  - BASF Personal Care and Nutrition GmbH, Dusseldorf, Germany.
FAU - Guth, Katharina
AU  - Guth K
AD  - BASF SE, Experimental Toxicology and Ecology, Ludwigshafen, Germany.
FAU - Ramirez, Tzutzuy
AU  - Ramirez T
AD  - BASF SE, Experimental Toxicology and Ecology, Ludwigshafen, Germany.
FAU - Honarvar, Naveed
AU  - Honarvar N
AD  - BASF SE, Experimental Toxicology and Ecology, Ludwigshafen, Germany.
FAU - Kolle, Susanne
AU  - Kolle S
AD  - BASF SE, Experimental Toxicology and Ecology, Ludwigshafen, Germany.
FAU - Landsiedel, Robert
AU  - Landsiedel R
AD  - BASF SE, Experimental Toxicology and Ecology, Ludwigshafen, Germany. Electronic 
      address: robert.landsiedel@basf.com.
FAU - Jaworska, Joanna
AU  - Jaworska J
AD  - Procter & Gamble NV, 100 Temselaan, 1853 Strombeek-Bever, Belgium.
FAU - Kern, Petra S
AU  - Kern PS
AD  - Procter & Gamble Technology (Beijing) Co., Ltd., China.
FAU - Gerberick, Frank
AU  - Gerberick F
AD  - Procter & Gamble Company, Cincinnati, OH, USA.
FAU - Natsch, Andreas
AU  - Natsch A
AD  - Givaudan Schweiz AG, Ueberlandstrasse 138, CH-8600 Dubendorf, Switzerland.
FAU - Emter, Roger
AU  - Emter R
AD  - Givaudan Schweiz AG, Ueberlandstrasse 138, CH-8600 Dubendorf, Switzerland.
FAU - Ashikaga, Takao
AU  - Ashikaga T
AD  - Shiseido Research Center, Shiseido Co., Ltd., 2-2-1 Hayabuchi, Tsuzuki-ku, 
      Yokohama-shi, Kanagawa 224-8558, Japan.
FAU - Miyazawa, Masaaki
AU  - Miyazawa M
AD  - Safety Science Research Laboratories, Kao Corporation, 2606 Akabane, Ichikai, 
      Haga, Tochigi 321-349, Japan.
FAU - Sakaguchi, Hitoshi
AU  - Sakaguchi H
AD  - Safety Science Research Laboratories, Kao Corporation, 2606 Akabane, Ichikai, 
      Haga, Tochigi 321-349, Japan.
LA  - eng
PT  - Journal Article
DEP - 20141223
PL  - Netherlands
TA  - Regul Toxicol Pharmacol
JT  - Regulatory toxicology and pharmacology : RTP
JID - 8214983
RN  - 0 (Dermatologic Agents)
SB  - IM
MH  - Animal Testing Alternatives/*methods
MH  - Animals
MH  - Cell Line
MH  - *Databases, Factual
MH  - Dermatologic Agents/*toxicity
MH  - Humans
MH  - Mice
MH  - Skin/*drug effects/pathology
MH  - U937 Cells
OTO - NOTNLM
OT  - (modified) MUSST
OT  - Adverse outcome pathway (AOP)
OT  - Allergic contact dermatitis (ACD)
OT  - DPRA
OT  - Database
OT  - Integrated testing strategy (ITS)
OT  - KeratinoSens
OT  - LuSens
OT  - Skin sensitization
OT  - h-CLAT
EDAT- 2014/12/30 06:00
MHDA- 2016/01/23 06:00
CRDT- 2014/12/27 06:00
PHST- 2014/09/22 00:00 [received]
PHST- 2014/12/15 00:00 [revised]
PHST- 2014/12/16 00:00 [accepted]
PHST- 2014/12/27 06:00 [entrez]
PHST- 2014/12/30 06:00 [pubmed]
PHST- 2016/01/23 06:00 [medline]
AID - S0273-2300(14)00309-2 [pii]
AID - 10.1016/j.yrtph.2014.12.008 [doi]
PST - ppublish
SO  - Regul Toxicol Pharmacol. 2015 Mar;71(2):337-51. doi: 10.1016/j.yrtph.2014.12.008. 
      Epub 2014 Dec 23.