PMID- 28602621
OWN - NLM
STAT- MEDLINE
DCOM- 20180417
LR  - 20181202
IS  - 1096-0295 (Electronic)
IS  - 0273-2300 (Linking)
VI  - 88
DP  - 2017 Aug
TI  - Binary test battery with KeratinoSens and h-CLAT as part of a bottom-up approach 
      for skin sensitization hazard prediction.
PG  - 118-124
LID - S0273-2300(17)30152-6 [pii]
LID - 10.1016/j.yrtph.2017.06.002 [doi]
AB  - Skin sensitization is one of the key safety endpoints for chemicals applied 
      directly to the skin. Several integrated testing strategies (ITS) using multiple 
      non-animal test methods have been developed to accurately evaluate the 
      sensitizing potential of chemicals, but there is no regulatory-accepted ITS to 
      classify a chemical as a non-sensitizer. In this study, the predictive 
      performance of a binary test battery with KeratinoSens and h-CLAT compared to 
      the local lymph node assay (LLNA) and human data was examined using comprehensive 
      dataset of 203 chemicals. When two negative results indicate a non-sensitizer, 
      the binary test battery provided sensitivity of 93.4% or 94.4% compared with the 
      LLNA or human data. Taking into account the predictive limitations (i.e. high log 
      Kow, pre-/pro-haptens and acyl transfer agents (or amine-reactive)), the binary 
      test battery had extremely high sensitivity comparable to that of the 3 out of 3 
      ITS where three negative results of the DPRA, KeratinoSens and h-CLAT indicate a 
      non-sensitizer. Therefore, the data from KeratinoSens or h-CLAT may provide 
      partly redundant information on the molecular initiating event derived from DPRA. 
      Taken together, the binary test battery of KeratinoSens and h-CLAT could be used 
      as part of a bottom-up approach for skin sensitization hazard prediction.
CI  - Copyright (c) 2017 Elsevier Inc. All rights reserved.
FAU - Otsubo, Yuki
AU  - Otsubo Y
AD  - Safety Science Research Laboratories, Kao Corporation, 2606 Akabane, Ichikai, 
      Haga, Tochigi 321-3497, Japan.
FAU - Nishijo, Taku
AU  - Nishijo T
AD  - Safety Science Research Laboratories, Kao Corporation, 2606 Akabane, Ichikai, 
      Haga, Tochigi 321-3497, Japan.
FAU - Miyazawa, Masaaki
AU  - Miyazawa M
AD  - Safety Science Research Laboratories, Kao Corporation, 2606 Akabane, Ichikai, 
      Haga, Tochigi 321-3497, Japan. Electronic address: miyazawa.masaaki@kao.co.jp.
FAU - Saito, Kazutoshi
AU  - Saito K
AD  - Safety Science Research Laboratories, Kao Corporation, 2606 Akabane, Ichikai, 
      Haga, Tochigi 321-3497, Japan.
FAU - Mizumachi, Hideyuki
AU  - Mizumachi H
AD  - Safety Science Research Laboratories, Kao Corporation, 2606 Akabane, Ichikai, 
      Haga, Tochigi 321-3497, Japan.
FAU - Sakaguchi, Hitoshi
AU  - Sakaguchi H
AD  - Safety Science Research Laboratories, Kao Corporation, 2606 Akabane, Ichikai, 
      Haga, Tochigi 321-3497, Japan.
LA  - eng
PT  - Journal Article
DEP - 20170607
PL  - Netherlands
TA  - Regul Toxicol Pharmacol
JT  - Regulatory toxicology and pharmacology : RTP
JID - 8214983
RN  - 0 (Allergens)
SB  - IM
MH  - Allergens/*adverse effects
MH  - Animal Testing Alternatives
MH  - Animals
MH  - Cell Line
MH  - Dermatitis, Allergic Contact/*diagnosis
MH  - Humans
MH  - *Local Lymph Node Assay
MH  - Sensitivity and Specificity
MH  - Skin/drug effects
OTO - NOTNLM
OT  - Bottom-up approach
OT  - Hazard identification
OT  - KeratinoSens
OT  - Skin sensitization
OT  - h-CLAT
EDAT- 2017/06/13 06:00
MHDA- 2018/04/18 06:00
CRDT- 2017/06/13 06:00
PHST- 2017/02/05 00:00 [received]
PHST- 2017/04/12 00:00 [revised]
PHST- 2017/06/05 00:00 [accepted]
PHST- 2017/06/13 06:00 [pubmed]
PHST- 2018/04/18 06:00 [medline]
PHST- 2017/06/13 06:00 [entrez]
AID - S0273-2300(17)30152-6 [pii]
AID - 10.1016/j.yrtph.2017.06.002 [doi]
PST - ppublish
SO  - Regul Toxicol Pharmacol. 2017 Aug;88:118-124. doi: 10.1016/j.yrtph.2017.06.002. 
      Epub 2017 Jun 7.