PMID- 37897225
OWN - NLM
STAT- MEDLINE
DCOM- 20240319
LR  - 20240319
IS  - 1099-1263 (Electronic)
IS  - 0260-437X (Linking)
VI  - 44
IP  - 4
DP  - 2024 Apr
TI  - The inter-laboratory validation study of EpiSensA for predicting skin 
      sensitization potential.
PG  - 510-525
LID - 10.1002/jat.4559 [doi]
AB  - The Epidermal Sensitization Assay (EpiSensA) is a reconstructed human epidermis 
      (RhE)-based gene expression assay for predicting the skin sensitization potential 
      of chemicals. Since the RhE model is covered by a stratified stratum corneum, 
      various kinds of test chemicals, including lipophilic ones and pre-/pro-haptens, 
      can be tested with a route of exposure akin to an in vivo assay and human 
      exposure. This article presents the results of a formally managed validation 
      study of the EpiSensA that was carried out by three participating laboratories. 
      The purpose of this validation study was to assess transferability of the 
      EpiSensA to new laboratories along with its within- (WLR) and between-laboratory 
      reproducibility (BLR). The validation study was organized into two independent 
      stages. As demonstrated during the first stage, where three sensitizers and one 
      non-sensitizer were correctly predicted by all participating laboratories, the 
      EpiSensA was successfully transferred to all three participating laboratories. 
      For Phase I of the second stage, each participating laboratory performed three 
      experiments with an identical set of 15 coded test chemicals resulting in WLR of 
      93.3%, 93.3%, and 86.7%, respectively. Furthermore, when the results from the 15 
      test chemicals were combined with those of the additional 12 chemicals tested in 
      Phase II of the second stage, the BLR for 27 test chemicals was 88.9%. Moreover, 
      the predictive capacity among the three laboratories showed 92.6% sensitivity, 
      63.0% specificity, 82.7% accuracy, and 77.8% balanced accuracy based on murine 
      local lymph node assay (LLNA) results. Overall, this validation study concluded 
      that EpiSensA is easily transferable and sufficiently robust for assessing the 
      skin sensitization potential of chemicals.
CI  - (c) 2023 John Wiley & Sons Ltd.
FAU - Mizumachi, Hideyuki
AU  - Mizumachi H
AUID- ORCID: 0000-0001-8778-1951
AD  - R&D Safety Science Research, Kao Corporation, 2606 Akabane, Ichikai-Machi, 
      Haga-Gun, Tochigi, 321-3497, Japan.
FAU - Watanabe, Mika
AU  - Watanabe M
AD  - Food and Drug Safety Center, Hatano Research Institute, 729-5 Ochiai, Hadano, 
      Kanagawa, 257-8523, Japan.
FAU - Ikezumi, Mayu
AU  - Ikezumi M
AD  - Food and Drug Safety Center, Hatano Research Institute, 729-5 Ochiai, Hadano, 
      Kanagawa, 257-8523, Japan.
FAU - Kajiwara, Michika
AU  - Kajiwara M
AD  - Food and Drug Safety Center, Hatano Research Institute, 729-5 Ochiai, Hadano, 
      Kanagawa, 257-8523, Japan.
FAU - Yasuda, Michiyo
AU  - Yasuda M
AD  - Food and Drug Safety Center, Hatano Research Institute, 729-5 Ochiai, Hadano, 
      Kanagawa, 257-8523, Japan.
FAU - Mizuno, Makoto
AU  - Mizuno M
AUID- ORCID: 0000-0002-2300-1618
AD  - Safety and Analytical Research Laboratories, KOSE Corporation, 48-18 Sakae-cho, 
      Kita-ku, Tokyo, 114-0005, Japan.
FAU - Imai, Noriyasu
AU  - Imai N
AUID- ORCID: 0000-0003-1488-4292
AD  - Safety and Analytical Research Laboratories, KOSE Corporation, 48-18 Sakae-cho, 
      Kita-ku, Tokyo, 114-0005, Japan.
FAU - Sakuma, Megumi
AU  - Sakuma M
AD  - Safety and Analytical Research Laboratories, KOSE Corporation, 48-18 Sakae-cho, 
      Kita-ku, Tokyo, 114-0005, Japan.
FAU - Shibata, Momoko
AU  - Shibata M
AD  - Safety and Analytical Research Laboratories, KOSE Corporation, 48-18 Sakae-cho, 
      Kita-ku, Tokyo, 114-0005, Japan.
FAU - Watanabe, Shin-Ichi
AU  - Watanabe SI
AD  - Safety Research Science Laboratory, LION Corporation, 100 Tajima, Odawara-shi, 
      Kanagawa, 256-0811, Japan.
FAU - Motoyama, Junko
AU  - Motoyama J
AD  - Safety Research Science Laboratory, LION Corporation, 100 Tajima, Odawara-shi, 
      Kanagawa, 256-0811, Japan.
FAU - Basketter, David
AU  - Basketter D
AD  - DABMEB Consultancy Ltd., Kingswood, Gloucestershire, GL12 8RN, UK.
FAU - Eskes, Chantra
AU  - Eskes C
AD  - Services and Consultation on Alternative Methods (SeCAM), Magliaso, Switzerland 
      and Swiss 3R Competence Centre (3RCC), Bern, Switzerland.
FAU - Hoffmann, Sebastian
AU  - Hoffmann S
AD  - seh consulting + services, Stembergring 15, Paderborn, 33106, Germany.
FAU - Lehmann, David M
AU  - Lehmann DM
AD  - Office of Research and Development, US Environmental Protection Agency, 109 T.W. 
      Alexander Drive, Research Triangle Park, NC, 27709, USA.
FAU - Ashikaga, Takao
AU  - Ashikaga T
AD  - Japanese Center for the Validation of Alternative Methods (JaCVAM), National 
      Institute of Health Sciences, 3-25-26 Tonomachi, Kawasaki-ku, Kanagawa, 210-9501, 
      Japan.
FAU - Sozu, Takashi
AU  - Sozu T
AD  - Department of Information and Computer Technology, Faculty of Engineering, Tokyo 
      University of Science, Katsushika-ku, Tokyo, 125-0051, Japan.
FAU - Takeyoshi, Masahiro
AU  - Takeyoshi M
AUID- ORCID: 0000-0001-8941-2076
AD  - Chemicals Assessment and Research Center, Chemicals Evaluation and Research 
      Institute (CERI), 1600 Shimotakano, Sugito-machi, Kitakatsushika-gun, Saitama, 
      345-0043, Japan.
FAU - Suzuki, Sho
AU  - Suzuki S
AD  - R&D Safety Science Research, Kao Corporation, 2606 Akabane, Ichikai-Machi, 
      Haga-Gun, Tochigi, 321-3497, Japan.
FAU - Miyazawa, Masaaki
AU  - Miyazawa M
AD  - R&D Safety Science Research, Kao Corporation, 2606 Akabane, Ichikai-Machi, 
      Haga-Gun, Tochigi, 321-3497, Japan.
FAU - Kojima, Hajime
AU  - Kojima H
AD  - Japanese Center for the Validation of Alternative Methods (JaCVAM), National 
      Institute of Health Sciences, 3-25-26 Tonomachi, Kawasaki-ku, Kanagawa, 210-9501, 
      Japan.
LA  - eng
GR  - Japanese Society for Alternative to Animal Experiments/
GR  - JP20mk0101131/Japan Agency for Medical Research and Development/
GR  - Long-range Research Initiative by the Japan Chemical Industry Association/
PT  - Journal Article
DEP - 20231028
PL  - England
TA  - J Appl Toxicol
JT  - Journal of applied toxicology : JAT
JID - 8109495
RN  - 0 (Allergens)
RN  - 0 (Haptens)
SB  - IM
MH  - Humans
MH  - Animals
MH  - Mice
MH  - Reproducibility of Results
MH  - *Allergens/toxicity
MH  - Epidermis
MH  - Skin
MH  - Haptens/toxicity
MH  - Local Lymph Node Assay
MH  - Animal Testing Alternatives
MH  - *Dermatitis, Allergic Contact
OTO - NOTNLM
OT  - gene expression
OT  - lipophilic chemical
OT  - non-animal test method
OT  - reconstructed human epidermis
OT  - skin sensitization
OT  - validation study
EDAT- 2023/10/28 11:45
MHDA- 2024/03/19 06:44
CRDT- 2023/10/28 05:42
PHST- 2023/10/10 00:00 [revised]
PHST- 2023/05/29 00:00 [received]
PHST- 2023/10/11 00:00 [accepted]
PHST- 2024/03/19 06:44 [medline]
PHST- 2023/10/28 11:45 [pubmed]
PHST- 2023/10/28 05:42 [entrez]
AID - 10.1002/jat.4559 [doi]
PST - ppublish
SO  - J Appl Toxicol. 2024 Apr;44(4):510-525. doi: 10.1002/jat.4559. Epub 2023 Oct 28.