PMID- 34993977
OWN - NLM
STAT- MEDLINE
DCOM- 20220614
LR  - 20220713
IS  - 1099-1263 (Electronic)
IS  - 0260-437X (Linking)
VI  - 42
IP  - 7
DP  - 2022 Jul
TI  - Applicability of amino acid derivative reactivity assay (4 mM) for the prediction 
      of skin sensitization by combining multiple alternative methods to evaluate key 
      events.
PG  - 1159-1167
LID - 10.1002/jat.4283 [doi]
AB  - The amino acid derivative reactivity assay (ADRA) is an alternative method for 
      evaluating key event 1 (KE-1) in the skin sensitization mechanism included in 
      OECD TG442C (OECD, 2021). Recently, we found that ADRA with a 4-mM test chemical 
      solution had a higher accuracy than the original ADRA (1 mM). However, ADRA 
      (4 mM) has yet to be evaluated using integrated approaches to testing and 
      assessment (IATA), a combination of alternative methods for evaluating KE. In 
      this study, the sensitization potency of three defined approaches (DAs) using 
      ADRA (4 mM) as KE-1 was predicted and compared with those of two additional ADRAs 
      or direct peptide reactivity assay (DPRA): (i) "2 out of 3" approach, (ii) "3 out 
      of 3" approach, and (iii) integrated testing strategy (ITS). In the hazard 
      identification of chemical sensitizers, the accuracy of human data and local 
      lymph node assay (LLNA) remained almost unchanged among the three approaches 
      evaluated. Potency classifications for sensitization were predicted with the LLNA 
      and human data sets using ITS. The potency classifications for the sensitization 
      potency prediction accuracy of LLNA data using any alternative method were almost 
      unchanged, at approximately 70%, and those with ITS were not significantly 
      different. When ITS was performed using DPRA, the prediction accuracy was 
      approximately 73% for human data, which was similar to that of the LLNA data; 
      however, the accuracy tended to increase for all ADRA methods. In particular, 
      when ITS was performed using ADRA (4 mM), the prediction accuracy was 
      approximately 78%, which proved to be a practical level.
CI  - (c) 2022 John Wiley & Sons, Ltd.
FAU - Imamura, Mika
AU  - Imamura M
AD  - Safety Evaluation Center, Fujifilm Corporation, Minamiashigara, Japan.
FAU - Yamamoto, Yusuke
AU  - Yamamoto Y
AUID- ORCID: 0000-0002-2014-9457
AD  - Safety Evaluation Center, Fujifilm Corporation, Minamiashigara, Japan.
FAU - Fujita, Masaharu
AU  - Fujita M
AUID- ORCID: 0000-0003-4345-1154
AD  - Safety Evaluation Center, Fujifilm Corporation, Minamiashigara, Japan.
FAU - Wanibuchi, Sayaka
AU  - Wanibuchi S
AD  - Safety Evaluation Center, Fujifilm Corporation, Minamiashigara, Japan.
FAU - Nakashima, Natsumi
AU  - Nakashima N
AD  - Safety Evaluation Center, Fujifilm Corporation, Minamiashigara, Japan.
FAU - Kojima, Hajime
AU  - Kojima H
AD  - Biological Safety Research Center, Division of Risk Assessment, National 
      Institute of Health Sciences, Kawasaki, Japan.
FAU - Ono, Atsushi
AU  - Ono A
AD  - Faculty of Pharmaceutical Sciences, Okayama University, Okayama, Japan.
FAU - Kasahara, Toshihiko
AU  - Kasahara T
AUID- ORCID: 0000-0001-7115-8452
AD  - Safety Evaluation Center, Fujifilm Corporation, Minamiashigara, Japan.
LA  - eng
PT  - Journal Article
DEP - 20220120
PL  - England
TA  - J Appl Toxicol
JT  - Journal of applied toxicology : JAT
JID - 8109495
RN  - 0 (Amino Acids)
RN  - 0 (Organic Chemicals)
RN  - 0 (Peptides)
SB  - IM
MH  - Amino Acids/chemistry
MH  - *Animal Testing Alternatives/methods
MH  - Animals
MH  - Biological Assay/methods
MH  - *Dermatitis, Allergic Contact/etiology/metabolism
MH  - Humans
MH  - Local Lymph Node Assay
MH  - Organic Chemicals
MH  - Peptides/chemistry
MH  - Skin/metabolism
OTO - NOTNLM
OT  - ADRA-FL
OT  - ADRA-UV
OT  - IATA
OT  - accuracy
OT  - amino acid derivative reactivity assay
OT  - in chemico
OT  - molar concentration
OT  - prediction
OT  - skin sensitization
EDAT- 2022/01/08 06:00
MHDA- 2022/06/15 06:00
CRDT- 2022/01/07 06:48
PHST- 2021/12/19 00:00 [revised]
PHST- 2021/10/16 00:00 [received]
PHST- 2021/12/19 00:00 [accepted]
PHST- 2022/01/08 06:00 [pubmed]
PHST- 2022/06/15 06:00 [medline]
PHST- 2022/01/07 06:48 [entrez]
AID - 10.1002/jat.4283 [doi]
PST - ppublish
SO  - J Appl Toxicol. 2022 Jul;42(7):1159-1167. doi: 10.1002/jat.4283. Epub 2022 Jan 
      20.