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e19 Invited Lecture Invited Lecture July 8 (Thu) 10:10 - 11:10 Room 1 Chair: Hideo FUKUI ( Axcelead Drug Discovery Partners, Inc. ) IL ○ Kohji NISHIDA Department of Ophthalmology, Osaka University Medical School Special Lecture Special Lecture 1 July 7 (Wed) 11:30 - 12:30 Room 5 Chair: Hideo FUKUI ( Axcelead Drug Discovery Partners, Inc. ) SL1 Risks and Benefits of Vaccine or Nonvaccine Therapeutic Interventions for COVID-19 ○ Kenneth L HASTINGS Hastings Toxicology Consulting LLC Special Lecture 2 July 7 (Wed) 13:50 - 14:50 Room 1 Chair: Yoshito KUMAGAI ( Environmental Biology Laboratory, Faculty of Medicine, University of Tsukuba ) SL2 Toward the Mysteries of Sleep ○ Masashi YANAGISAWA International Institute for Integrative Sleep Medicine (WPI-IIIS) Special Lecture 3 July 8 (Thu) 9:00 - 10:00 Room 1 Chair: Ikuo HORII ( Pfizer, Global ) SL3 Development Challenges for Carcinogenicity Risk Assessments of Topical Drugs ○ Brett D HOLLINGSHEAD, Nasir KHAN, Maik SCHULER, Zaher RADI Pfizer Drug Safety Research and Development Program

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Page 1: Special Lecture

e19

Invited Lecture Invited Lecture July 8 (Thu) 10:10 - 11:10

Room 1

Chair: Hideo FUKUI (Axcelead Drug Discovery Partners, Inc.)

IL ○ Kohji NISHIDA Department of Ophthalmology, Osaka University Medical School

Special Lecture Special Lecture 1 July 7 (Wed) 11:30 - 12:30

Room 5

Chair: Hideo FUKUI (Axcelead Drug Discovery Partners, Inc.)

SL1 RisksandBenefitsofVaccineorNonvaccineTherapeuticInterventionsforCOVID-19○ Kenneth L HASTINGS

Hastings Toxicology Consulting LLC

Special Lecture 2 July 7 (Wed) 13:50 - 14:50Room 1

Chair: Yoshito KUMAGAI (Environmental Biology Laboratory, Faculty of Medicine, University of Tsukuba)

SL2 TowardtheMysteriesofSleep○ Masashi YANAGISAWA

International Institute for Integrative Sleep Medicine (WPI-IIIS)

Special Lecture 3 July 8 (Thu) 9:00 - 10:00Room 1

Chair: Ikuo HORII (Pfizer, Global)

SL3 DevelopmentChallengesforCarcinogenicityRiskAssessmentsofTopicalDrugs○ Brett D HOLLINGSHEAD, Nasir KHAN, Maik SCHULER, Zaher RADI

Pfizer Drug Safety Research and Development

Program

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EducationalLectureEducationalLecture1 July 7 (Wed) 11:30 - 12:30

Room 1

Chair: Hirohiko OHTSUKA (Axcelead Drug Discovery Partners, Inc.)

EL1 Immune-enhancingadjuvantfordevelopmentofsafevaccines○ Tsukasa SEYA1, 2, Misako MATSUMOTO1, 2

1Nebuta Research Institute for Life Sciences, Aomori University, 2Hokkaido University Graduate School of Medicine

EducationalLecture2 July 8 (Thu) 11:20 - 12:20Room 1

ACT/JSOT:EducationalLectureChair: Hideo FUKUI (Axcelead Drug Discovery Partners, Inc.)

EL2-1 StreamlinedDevelopmentApproachtoEvaluatingSeverelydebilitatingorlife-threateningindications(SDLTs)TherapeuticsandVaccines○ Judith PRESCOTT

Merck & Co.

EL2-2 TheComingConquestofCOVID○ Robert W. AMLER

New York Medical College

EducationalLecture3 July 9 (Fri) 9:00 - 10:00Room 1

Chair: Tadahiro SHINOZAWA (Takeda Pharmaceutical Company Limited)

EL3 ThePromiseofOrganoidMedicine○ Takanori TAKEBE1, 2, 3, 4

1Institute of Research, Tokyo Medical and Dental University, 2Communication Design Center, Yokohama City University, 3Center for Stem Cell and Organoid Medicine, Cincinnati Children's Hospital Medical Center, 4Division of Gastroenterology, Hepatology and Nutrition and Division of Developmental Biology, Cincinnati Children's Hospital Medical Center

EducationalLecture4 July 9 (Fri) 10:10 - 11:10Room 1

Chair: Yoshito KUMAGAI (Environmental Biology Laboratory, Faculty of Medicine, University of Tsukuba)

EL4 PatientCentricity-Importanceoftoxicologyinpharmaceuticalcompanies○ Sunao MANABE

Daiichi Sankyo Co., Ltd.

Program

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EducationalLecture5 July 9 (Fri) 11:10 - 12:10Room 2

ACT/JSOT:EducationalLectureChair: Hideo FUKUI (Axcelead Drug Discovery Partners, Inc.)

EL5-1 TheUSFDA’sCoronavirusTreatmentAccelerationProgram(CTAP)andConsiderationsforPre-INDMeetingRequests○ Stephanie Leuenroth QUINN

US FDA

EL5-2 IntegratedReviewProcesswithintheOfficeofNewDrugs○ Stephanie Leuenroth QUINN

US FDA

EducationalLecture6 July 9 (Fri) 9:00 - 10:00Room 3

Chair: Masahiko SATOH (School of Pharmacy, Aichi Gakuin University)

EL6 NoveldefensestrategyagainstprogressiveneurodegenerationbycontrollingintracellularZn2+dysregulation○ Atsushi TAKEDA

Department of Neurophysiology, School of Pharmaceutical Sciences, University of Shizuoka

EducationalLecture7 July 9 (Fri) 10:10 - 11:10Room 3

Chair: Toshiyuki KAJI ( Department of Environmental Health, Faculty of Pharmaceutical Sciences, Tokyo University of Science)

EL7 Covid-19,Mutations,ImmuneResponsesandVaccines○ Tatsuhiko KODAMA

RCAST, University of Tokyo

EducationalLecture8 July 9 (Fri) 13:30 - 14:30Room 2

Chair: Ikuma YOSHIDA (Axcelead Drug Discovery Partners, Inc.)

EL8 Computationaltoxicologyandtheregulatoryenvironment– past,present,andfuture○ David R WOOLLEY

ForthTox Limited

Program

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SymposiumSymposium1 July 7 (Wed) 9:20 - 11:20

Room 1

Toxico-epigenomicslearnedfromaviewpointofdevelopmentalbiologyandcongenitalanomaly2.0Chairs: Kinichi NAKASHIMA (Graduate School of Medical Sciences, Kyushu University)

Satoshi KITAJIMA ( Division of Cellular & Molecular Toxicology, Center for Biological Safety & Research, National Institute of Health Sciences)

9:20 - 9:45S1-1 PossibleinvolvementofendogenousDNA-inducedmicroglialactivation

inthepathogenesisofRettsyndromeHideyuki NAKASHIMA, ○ Kinichi NAKASHIMA

Graduate School of Medical Sciences, Kyushu University

9:45 - 10:10S1-2 Establishmentofepigeneticlandscapeduringvertebrateearly

development–Quantitativeanalysisofhistonemodificationsin medakaembryos○ Hiroyuki TAKEDA

Department of Biological Sciences, Graduate School of Science, University of Tokyo

10:10 - 10:35S1-3 Environmentallyinducedepigeneticchangesandtheireffects

○ Kenichiro HATA Department of Maternal-Fetal Biology, National Research Institute for Child Health and Development

10:35 - 10:55S1-4 AdvancedDevelopmentandItsSafetyEvaluationofEpigeneticDrugs

○ Kenji TAKI Drug Safety R&D, Pfizer R&D Japan

10:55 - 11:15S1-5 Toxicityevaluationbyliquidbiopsy

○ Ryuichi ONO Division of Cellular and Molecular Toxicology, Center for Biological Safety and Research (CBSR), National Institute of Health

Sciences (NIHS)

11:15 - 11:20Discussion

Program

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Symposium2 July 7 (Wed) 9:20 - 11:20Room 2

JALAS-JSOTJointSymposiumChairs: Hisaharu YAMADA (Taisho Pharmaceutical Co., Ltd.)

Masahito IKAWA (RIMD, Osaka University)

9:20 - 9:25Introduction

○ Hisaharu YAMADA Taisho Pharmaceutical Co., Ltd.

9:25 - 9:52S2-1 Generationofhumanizedanimalmodelusingmouse/humanartificial

chromosomesandtheapplicationfordrugdiscovery○ Yasuhiro KAZUKI

Chromosome Engineering Research Center, Tottori University

9:52 - 10:19S2-2 Translationalresearchwithpigsspecializinginmedicalapplication

○ Arata HONDA Center for Development of Advanced Medical Technology, Jichi Medical University

10:19 - 10:46S2-3 Characterizationofchimericmicerepopulatedwithhumanhepatocytes

andtheirutilizationintoxicologicalstudies○ Chise TATENO1, 2

1PhoenixBio Co., Ltd., 2Research Center for Hepatology and Gastroenterology, Hiroshima University

10:46 - 11:13S2-4 Challengeinevaluatinghumanlivercarcinogenicityofchemicals:

Applicationofchimericmicewithhumanhepatocytes○ Tomoya YAMADA

Environmental Health Science Laboratory, Sumitomo Chemical Co., Ltd.

11:13 - 11:20Conclusion

○ Masahito IKAWA RIMD, Osaka University

Symposium3 July 7 (Wed) 9:20 - 11:50Room 3

NewtrendsingenotoxicityresearchinvolvinggenomeinstabilityChairs: Kei-ichi SUGIYAMA ( Division of Genetics and Mutagenesis, Center for Biological Safety and Research, National

Institute of Health Sciences)Masayuki MISHIMA (Translational Research Division, Chugai Pharmaceutical)

9:20 - 9:45S3-1 Whydon’twegetstarted,nextgenerationgenotoxicologyconsidering

genomicinstability?○ Masayuki MISHIMA

Translational Research Division, Chugai Pharmaceutical

Program

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9:45 - 10:10S3-2 Studiesonmolecularmechanismsofmutationinductionand

suppressionusinggeneticallymodifiedcells○ Tetsuya SUZUKI

Graduate School of Biomedical and Health Sciences, Hiroshima University

10:10 - 10:35S3-3 Genomereprogramming-associatedpointmutations,frequency

andmechanisms○ Ryoko ARAKI1, Yuko HOKI1, Tomo SUGA1, Misato SUNAYAMA1, Kaori IMADOME1, Satoshi KAMIMURA1, Miki NAKAMURA1, Mayumi FUJITA1, Masumi ABE2

1Stem Cell Biology Group, Institute for Quantum Life Science, QST, 2Quantum Life and Medical Science Directorate, QST

10:35 - 10:55S3-4 Genomeinstabilitythroughepigeneticaberrations

causedbymycotoxins○ Kei-ichi SUGIYAMA

Division of Genetics and Mutagenesis, Center for Biological Safety and Research, National Institute of Health Sciences

10:55 - 11:20S3-5 RequirementsandexampleforAmes/QSARandinsilico studies

○ Ayako FURUHAMA1, Kei-ichi SUGIYAMA1, Masamitsu HONMA2

1Division of Genetics and Mutagenesis, Center for Biological Safety and Research, National Institute of Health Sciences, 2National Institute of Health Sciences

11:20 - 11:45S3-6 Necessityof(Q)SARforMutagenicityPredictionin

DrugDevelopmentandDiscovery,andaCaseStudyof Mechanism-BasedMutagenicityPrediction○ Shigeharu MUTO

Mitsubishi Tanabe Pharma Corporation (Current affiliation: Chugai Pharmaceutical Co., Ltd.)

11:45 - 11:50Conclusion

Symposium4 July 7 (Wed) 9:20 - 11:20Room 4

Chemicalsensingtranscriptionfactors:TowardunderstandingtoxicitymechanismandriskassessmentChairs: Kouichi YOSHINARI (Laboratory of Molecular Toxicology, School of Pharmaceutical Sciences, University of Shizuoka)

Hiroyuki KOJIMA ( Division of Environmental Health and Sciences, School of Pharmaceutical Sciences, Health Sciences University of Hokkaido)

9:20 - 9:22Introduction

9:22 - 9:51S4-1 Biomonitoringofhormonalactivitiesinenvironmentalwaterbytheuse

ofgenome-editedDaphniaLi-Chi HSIEH, Ayano NODA, Nikko ADHITAMA, Yasuhiko KATO, ○ Hajime WATANABE

Department of Biotechnology, Osaka University

Program

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9:51 - 10:20S4-2 ImmunotoxicologicaleffectsofbenzotriazoleUVstabilizersthrough

activationofarylhydrocarbonreceptor○ Hiroyuki KOJIMA1, Atsuhito KUBOTA1, Masaru TERASAKI1, Ryuta MUROMOTO2, Hideshige TAKADA3

1Division of Environmental Health and Sciences, School of Pharmaceutical Sciences, Health Sciences University of Hokkaido, 2Division of Immunology, Graduate School of Pharmaceutical Sciences, Hokkaido University, 3Laboratory of Organic Geochemistry, Faculty of Agriculture, Tokyo University of Agriculture and Technology

10:20 - 10:49S4-3 Identificationofendpointsforandrogenrelated-toxicitybyusing

androgenoverproducingtransgenicmiceandtheirapplicationtotoxicitytests○ Tsuyoshi NAKANISHI

Laboratory of Hygienic Chemistry and Molecular Toxicology, Gifu Pharmaceutical University

10:49 - 11:18S4-4 Understandingtheunderlyingmechanismofnuclearreceptor

CAR-mediatedlivercancer○ Ryota SHIZU, Kouichi YOSHINARI

Laboratory of Molecular Toxicology, School of Pharmaceutical Sciences, University of Shizuoka

11:18 - 11:20Conclusion

Symposium5 July 7 (Wed) 9:20 - 11:20Room 5

Japaneseperspectivesonpreclinicalsafetyevaluationofpharmaceuticalsforpandemicinfection(LearningfromCOVID-19pandemic)Chairs: Takanori IKEDA (Safety Assessment, MSD K.K.)

Kazushige MAKI (PMDA)

9:20 - 9:23Introduction

9:23 - 9:51S5-1 DestructiveinnovationofCOVID-19vaccinedevelopment

○ Ken J ISHII1, 2

1Division of Vaccine Science, The Institute of Medical Science, The University of Tokyo, 2National Institute of Biomedical Innovation, Health and Nutrition

9:51 - 10:19S5-2 RevisionoftheGuidelineforNon-clinicalStudiesonVaccinesforthe

PreventionofInfectiousDiseases○ Yumiko NOMURA1, Kiyohito NODA2, Yuusuke OOHASHI1, Mayumi SHIKANO1, 2

1Graduate School of Pharmaceutical Sciences, Tokyo University of Science, 2Faculty of Pharmaceutical Sciences, Tokyo University of Science

10:19 - 10:47S5-3 APMDAperspectiveonpreclinicalassessmentforCOVID-19vaccine

○ Kazushige MAKI Pharmaceuticals and Medical Devices Agency

Program

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10:47 - 11:15S5-4 ConsiderationsforNonclinicalSafetyAssessmentinINDsandNDAsfor

COVID-19Therapeutics:PMDAViewpoints○ Satoshi TSUNODA

Pharmaceuticals and Medical Devices Agency

11:15 - 11:16Conclusion

Symposium6 July 7 (Wed) 10:30 - 12:30Room 6

JSOT-SOTExchangePromotionProgram:CRISPRandOpportunitiesforToxicologyChair: Akihiko HIROSE (National Institute of Health Sciences)

10:30 - 10:32OpeningRemark

10:32 - 11:02S6-1 ExploringthepotentialforCRISPRinToxicology:AnIntroduction

○ Myrtle DAVIS Discovery Toxicology, Pharmaceutical Candidate Optimization, Bristol Myers Squibb

11:02 - 11:31S6-2 ExploringNewFrontiersofMechanisticToxicitywithCRISPR/Cas9

○ Jeff WILLY Vertex Pharmaceuticals

11:31 - 12:00S6-3 Novelapplicationofhuman-derivediPScelllinesusefulasalternatives

toanimaltoxicitytestingofpharmaceuticals○ Naoki YAMAMOTO1, 2, Noriko HIRAMATSU1, Hiroshi SASAKI2, Masashi KONDO1, Hajime KOJIMA3

1Center for Clinical Trial and Research Support, Research Promotion and Support Headquarters, Fujita Health University, 2Department of Ophthalmology, School of Medicine, Kanazawa Medical University, 3Division of Risk Assessment, NIHS

12:00 - 12:29S6-4 Applicationfordrugdiscoveryusingmammalianartificialchromosomes

andgenomeeditingtechnology○ Yasuhiro KAZUKI

Chromosome Engineering Research Center, Tottori University

12:29 - 12:30ClosingRemark

Program

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Symposium7 July 7 (Wed) 14:50 - 16:50Room 2

Speciesdifferencesandpredictionofhumanresponseswithbiotherapeutics:reviewthemonkeyasalaboratoryanimalChairs: Satoshi KITAJIMA ( Division of Cellular & Molecular Toxicology, Center for Biological Safety & Research, National

Institute of Health Sciences)Mutsumi SUZUKI ( Toxicological Research Laboratories, Translational Research Unit, R&D Division Kyowa Kirin Co., Ltd.)

14:50 - 15:14S7-1 Appropriatenessandlimitationsofnonclinicalevaluationinmonkey

○ Mutsumi SUZUKI Toxicological Research Laboratories, Translational Research Unit, R&D Division Kyowa Kirin Co., Ltd.

15:14 - 15:38S7-2 Viewpointfromreviewofbiopharmaceuticals

○ Mineo MATSUMOTO Division of Asia 1, Office of International Programs, Pharmaceutical and Medical Devices Agency (PMDA)

15:38 - 16:02S7-3 Speciesdifferenceininductionofanti-PEGIgMbyPEGylatedmaterials

anditsinfluenceinpharmacokineticsofPEGylateddrugs○ Tatsuhiro ISHIDA

Department of Pharmacokinetics and Biopharmaceutics, Institute of Biomedical Sciences, Tokushima University

16:02 - 16:26S7-4 Non-clinicalsafetyassessmentofantibodydrugs;

howrelevantaremonkeystudies?○ Masayuki MISHIMA

Translational Research Division, Chugai Pharmaceutical

16:26 - 16:50S7-5 AnimalWelfareinNon-humanPrimates

-FromthePerspectiveofAttendingVeterinarian-○ Takehito ISOBE

Research Division, Chugai Pharmaceutical Co., Ltd.

Symposium8 July 7 (Wed) 14:50 - 16:50Room 3

Riskassessmentsfordrug-inducedconvulsionsChairs: Motohiro SHIOTANI (Global Drug Safety, Eisai Co., Ltd.)

Takafumi SHIRAKAWA (Astellas Pharma Inc.)

14:50 - 14:52Introduction

14:52 - 15:21S8-1 Druginducedseizure:anoverviewfromaclinicalperspective

○ Riki MATSUMOTO Division of Neurology, Kobe University Graduate School of Medicine

15:21 - 15:50S8-2 Drug-inducedseizureriskassessmentsbasedoninvitro,exvivo,

invivoneuralnetworkactivities○ Ikuro SUZUKI

Department of Electronics, Tohoku Institute of Technology

Program

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15:50 - 16:19S8-3 Challengetobetterassessmentofconvulsionriskinhumanusing

preclinical data○ Motohiro SHIOTANI

Global Drug Safety, Eisai Co., Ltd.

16:19 - 16:48S8-4 Measurementandanalysistechnologyusingwearablesystemfor

predictionofautonomicchangerelatedtoneurologicalsymptoms andhealthcondition○ Toshitaka YAMAKAWA1, Koich FUJIWARA2, Manabu KANO3, Miho MIYAJIMA4, Taketoshi MAEHARA5

1Faculty of Advanced Science and Technology, Kumamoto University, 2Graduate School of Engineering, Nagoya University, 3Graduate School of Informatics, Kyoto University, 4Section of Liaison Psychiatry and Palliative Medicine, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, 5Department of Neurosurgery, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University

16:48 - 16:50Conclusion

Symposium9 July 7 (Wed) 14:50 - 17:20Room 4

ToxicOmicAIanalysisenhancedwithepigenomicsdataChairs: Masatoshi HAGIWARA ( Deaprtment of Anatomy and Developmental Biology, Graduate School of Medicine,

Kyoto University)Jun KANNO (National Institute of Health Sciences)

14:50 - 14:53Introduction

14:53 - 15:28S9-1 ○ Hiroaki KITANO

The Systems Biology Institute

15:28 - 16:03S9-2 Comprehensiveevaluationofpseudoexonicsplicingmutationsfor

drugdevelopment○ Masatoshi HAGIWARA

Deaprtment of Anatomy and Developmental Biology, Graduate School of Medicine, Kyoto University

16:03 - 16:38S9-3 ComparativetoxicologenomicsofPPARαligands

○ Yayoi NATSUME-KITATANI1, Ken-ichi AISAKI2, Satoshi KITAJIMA2, Samik GHOSH3, 4, Hiroaki KITANO3, 5, Kenji MIZUGUCHI1, 6, Jun KANNO2

1National Institutes of Biomedical Innovation, Health and Nutrition, 2National Institute of Health Sciences, 3The Systems Biology Institute, 4SBX Corporations, 5Okinawa Institute of Science and Technology Graduate University, 6Osaka University

16:38 - 17:13S9-4 ToxicOmicsandAIforpredictionofchronictoxicity

○ Jun KANNO, Ken-ichi AISAKI, Ryuichi ONO, Satoshi KITAJIMA Division of Cellular and Molecular Toxicolog, CBSR, National Institute of Health Sciences

Program

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17:13 - 17:20Discussion

Symposium10 July 7 (Wed) 14:50 - 16:50Room 5

NonclinicalsafetyevaluationandfutureperspectivesofgenetherapyproductsChairs: Kazushige MAKI (PMDA)

Takanori IKEDA (Safety Assessment, MSD K.K.)

14:50 - 14:53Introduction

14:53 - 15:21S10-1 CurrentUnderstandingandDevelopmentStatusofGeneTherapy

○ Daisuke TENMIZU1, 2

1Japan Pharmaceutical Manufacturers Association, 2Analysis & Pharmacokinetics Research Labs., Astellas Pharma Inc.

15:21 - 15:49S10-2 NonclinicalsafetyevaluationforinvivogenetherapyproductsatPMDA

○ Misaki NAOTA Pharmaceuticals and Medical Devices Agency

15:49 - 16:17S10-3 Pointstoconsiderforthedevelopmentofinvivogenomeediting

therapies○ Kohnosuke MITANI

Research Center for Genomic Medicine, Saitama Medical University

16:17 - 16:45S10-4 ICHS12draftguidelineon“Nonclinicalbioditributionconsiderationsfor

genetherapyproducts”○ Mizuho NONAKA

Pharmaceuticals and Medical Devices Agency

16:45 - 16:46Conclusion

Symposium11 July 7 (Wed) 14:50 - 16:50Room 6

ReproductiveanddevelopmentaltoxicityinthepreventionandtreatmentofinfectiousdiseasesChairs: Kazuhiro SHIMOMURA (Vaccine Research Laboratories, Daiichi Sankyo Co., Ltd.)

Tsuyoshi NAKANISHI (Laboratory of Hygienic Chemistry and Molecular Toxicology, Gifu Pharmaceutical University)

14:50 - 14:54Introduction

14:54 - 15:22S11-1 Reproductiveanddevelopmentaltoxicityinantimicrobialdrugs

○ Yoshiki BAN Department of Animal Risk Management, Faculty of Risk and Crisis Management, Chiba Institute of Science

Program

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15:22 - 15:50S11-2 Teratogenicityofantiviraldrugs

○ Yuko IZUMI Drug Safety Research and Evaluation, Research, Takeda Pharmaceutical Company Limited

15:50 - 16:18S11-3 Non-clinicalsafetyevaluationforvaccinationduringpregnancy

○ Kazuhiro SHIMOMURA Vaccine Research Laboratories, Daiichi Sankyo Co., Ltd.

16:18 - 16:46S11-4 Anti-infectivesandvaccinesinpregnancyandlactation

○ Omi WATANABE Japan Drug Information Institute in Pregnancy, National Center for Child Health and Development

16:46 - 16:50Conclusion

Symposium12 July 8 (Thu) 9:00 - 11:30Room 2

AIandInformaticsforthesafetyevaluationofchemicalcompoundsChairs: Kouichi YOSHINARI (Laboratory of Molecular Toxicology, School of Pharmaceutical Sciences, University of Shizuoka)

Yoshihiro YAMANISHI (Kyushu Institute of Technology)

9:00 - 9:29S12-1 Predictionofanemiaandhepatotoxicitybasedonphysicochemical

propertiesofchemicalcompounds:challengeswithtoxicitysmalldata○ Kouichi YOSHINARI

Laboratory of Molecular Toxicology, School of Pharmaceutical Sciences, University of Shizuoka

9:29 - 9:58S12-2 CurrentopportunitiesandchallengesforOpen-AccessComputational

ToxicologyTooldevelopment○ Hiroshi YAMADA

Toxicogenomics Informatics Project, National Institutes of Biomedical Innovation, Health and Nutrition

9:58 - 10:27S12-3 Applicationofartificialintelligencetopredictcompoundtoxicityand

challengetofederatedlearningindrugdiscovery○ Hideyoshi FUJI

Astellas Pharma Inc.

10:27 - 10:56S12-4 Predictionofcompoundtoxicitiesandside-effectsusinginterpretable

machinelearningmodels○ Yoshihiro YAMANISHI

Department of Bioscience and Bioinformatics, Faculty of Computer Science and Systems Engineering, Kyushu Institute of Technology

10:56 - 11:25S12-5 RAxlinkedwithinsilicoandinvitrostudyforchemicaldevelopment

○ Yuko NUKADA R&D - Core Technology - Safety Science Research, Kao Corporation

11:25 - 11:30Discussion

Program

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Symposium13 July 8 (Thu) 9:00 - 10:30Room 3

ToxicologicalassessmentbytoxicitydatabaseusingdatafromhumanEScells/iPScellsChairs: Hajime KOJIMA (National Institute of Health Sciences)

Mutsumi SUZUKI (Toxicological Research Laboratories, Translational Research Unit, R&D Division Kyowa Kirin Co., Ltd.)

9:00 - 9:05Introduction

9:05 - 9:25S13-1 NephrotoxicitypredictionsystemusinghumanESandiPScells

○ Hironori OTSUKI1, 2, Junko YAMANE2, Koji INOMATA1, Ayako MIWA1, Teppei SHIOJI1, Tetsuro ARAKI1, Masanori HIURA1, Wataru FUJIBUCHI2

1Kyowa Kirin Co., Ltd., 2Center for iPS Cell Research and Application (CiRA), Kyoto University

9:25 - 9:45S13-2 ApplicationofadulttoxicitypredictionsystemusinghumanESCs

○ Junko YAMANE1, Hironori OTSUKI2, Koji INOMATA2, Mutsumi SUZUKI2, Hideko SONE3, Wataru FUJIBUCHI1

1Center for iPS Cell Research and Application, Kyoto University, 2Translational Research Unit, R&D Division, Kyowa Kirin Co., Ltd., 3Environmental Health and Prevention Research Unit, Yokohama University of Pharmacy

9:45 - 10:05S13-3 Evaluationoftoxicitiesofchemicalsubstancesbyutilizing

transcriptomedatabaseinundifferentiatedcells○ Shuichi SEKINE1, Junko YAMANE2, Tomoka HISAKI1, Hirokazu KOUZUKI1, Wataru FUJIBUCHI2

1Shiseido Co. Ltd. Global Innovation Center, 2Center for iPS Cell Research and Application (CiRA), Kyoto University

10:05 - 10:25S13-4 Assessmentofchemicalsbytoxicityreactiondatabaseusinghuman

ESCs/iPSCs○ Wataru FUJIBUCHI1, Hideko SONE2

1Center for iPS Cell Research and Application, Kyoto University, 2Yokohama University of Pharmacy

10:25 - 10:30Conclusion

Symposium14 July 8 (Thu) 9:00 - 11:00Room 4

Newinsightsofinvivosafetyassessmentstrategyfordrug-inducedcardiacfunctionalchangeChairs: Katsuyoshi CHIBA (Daiichi Sankyo, Inc.)

Satoshi TSUNODA (Pharmaceuticals and Medical Devices Agency)

9:00 - 9:10Introduction

○ Katsuyoshi CHIBADaiichi Sankyo, Inc.

Program

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9:10 - 9:35S14-1 Apresentstateandperspectiveofpreclinicalinvivostudiesfor

evaluatingQTprolongationandproarrhythmicpotential○ Ryuichi KOMATSU

Non-Clinical Safety Assessment Department

9:35 - 10:00S14-2 Currentstatusandfutureperspectivesofinvivocardiacfunction

assessmentinnon-clinicalstudies○ Tomomichi ISHIZAKA, Katsuyoshi CHIBA, Kazuhiko MORI

Medicinal Safety Research Laboratories, Daiichi Sankyo Co., Ltd.

10:00 - 10:25S14-3 Cardiacriskassessmentinanti-cancerdrugs

○ Hideaki TAKAHASHI Pharmaceuticals and Medical Devices Agency

10:25 - 10:50S14-4 ConsiderationsforNonclinicalCardiovascularRiskAssessmentinIND

andNDA:PMDAViewpoints○ Satoshi TSUNODA

Pharmaceuticals and Medical Devices Agency

10:50 - 11:00Discussion

Symposium15 July 8 (Thu) 9:00 - 11:30Room 5

JSTP-JSOTJointSymposium:TopicsfromtheSocietyofToxicologicalPathology:ApproachofModeofActionforsafetyevaluationofchemicalsubstancesChairs: Kumiko OGAWA (National Institute of Helath Sciences)

Kosei INUI (Ishihara Sangyo Kaisha, Ltd.)

9:00 - 9:05Introduction

○ Kumiko OGAWANational Institute of Helath Sciences

9:05 - 9:35S15-1 Speciesdifferencesintoxicityof4-hydroxyphenylpyruvatedioxygenase

(4-HPPD)inhibitorsonthecorneaoftheeyeandmolecularlayerofthecerebellum○ Mika NAGAIKE

Safety Science Research Laboratory, Central Research Institute, Ishihara Sangyo Kaisha, LTD.

9:35 - 10:05S15-2 Evaluationofthehumanrelevanceofchemicallyinducedliver

carcinogenesisbyusingchimericmicewithhumanhepatocytes○ Keiko OGATA, Hiroyuki ASANO, Kaori MIYATA, Tokuo SUKATA, Tomoya YAMADA

Environmental Health Science Laboratory, Sumitomo Chemical Co., Ltd.

Program

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10:05 - 10:35S15-3 Modeofaction(MOA)ofchemical-inducedstomachcarcinoidtumor

in rats○ Satoshi FURUKAWA1, Takanori HARADA2

1Toxicology & Environmental Science Department, Biological Research Laboratories, Nissan Chemical Corporation, 2The Institute of Environmental Toxicology

10:35 - 11:05S15-4 Relationshipbetweenaromataseinhibitoryactivityinanewchemical

entityandreproductiveabilityinrats○ Shiori YOSHIDA

Product Safety and Pharmaceutical Research Group, Research Center, Nihon Nohyaku Co., Ltd.

11:05 - 11:10Conclusion

○ Kosei INUIIshihara Sangyo Kaisha, Ltd.

11:10 - 11:30Discussion

Symposium16 July 8 (Thu) 9:00 - 11:30Room 6

Children’stoxicologywithrespecttobrainfunctionChairs: Makiko KUWAGATA (National Institute of Health Sciences)

Kentaro TANEMURA ( Laboratory of Animal Reproduction and Development Graduate School of Agricultural Science Tohoku University)

9:00 - 9:01Introduction

9:01 - 9:11S16-1 Introductiontothesession“Children’stoxicologywithrespectto

brainfunction”○ Jun KANNO

Division of Cellular and Molecular Toxicolog, CBSR, National Institute of Health Sciences

9:11 - 9:41S16-2 FromDOHaDtoPOHaD:EffectsofSpermatogonialEpimutationon

Next-GenerationBrainDevelopment○ Noriko OSUMI

Department of Developmental Neuroscience, Tohoku University Graduate School of Medicine

9:41 - 10:11S16-3 IsthenumberofpatientofAutismSpectrumDisorder(developmental

disorder)increasing?○ Go ICHIKAWA

Department of Pediatrics, Dokkyo Medical University

Program

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10:11 - 10:41S16-4 Environmentalriskfactorsofneurodevelopmentaldisorders:

fromcurrentknowledgetowardsfutureresearch○ Kenji J. TSUCHIYA1, 2, Tomoko NISHIMURA1, 2, Akemi OKUMURA1, 2, Taeko HARADA1, 2, Toshiki IWABUCHI1, 2, Mohammad Shafiur RAHMAN1, 2, Nagahide TAKAHASHI2, 3

1Research Center for Child Mental Development, Hamamatsu University School of Medicine, 2United Graduate School of Child Development, Osaka University, Kanazawa University, Hamamatsu University School of Medicine, Chiba University, and University of Fukui, 3Nagoya University Graduate School of Medicine, Department of Child and Adolescent Psychiatry

10:41 - 11:01S16-5 Neurobehavioraltoxicityinducedbyexposureoflow-levelchemical

substancesinearlylifeanditsevaluation-Focusingontheanalysisoftheneurobehavioraleffectsofneonicotinoidexposureonmice-

○ Hirokatsu SAITO1, Satoshi KITAJIMA1, Jun KANNO3, Kentaro TANEMURA2

1Division of Cellular and Molecular Toxicology, Center for Biological Safety and Research, National Institute of Health Sciences, 2Laboratory of Animal Reproduction and Development, Graduate School of Agricultural Science, Tohoku University, 3National Institute of Health Sciences

11:01 - 11:29Discussion

○ Taiichi KATAYAMA (Osaka University, United Graduate School of Child Development, Osaka University, Kanazawa University, Hamamatsu University School of Medicine, Chiba University and University of Fukui)

○ Yuuki MIYATAKE (Ministry of Health, Labour and Welfare), Chairs and Speakers

11:29 - 11:30Conclusion

Symposium17 July 8 (Thu) 15:00 - 17:00Room 2

LatestinformationonsafetyevaluationofpesticideintheworldChairs: Mie WATANABE-AKANUMA (Safety Resear Center, KUREHA CORPORATION )

Satoshi FURUKAWA (Nissan Chemical Corporation)

15:00 - 15:01Introduction

15:01 - 15:04S17-1 Thelatestinformationonthesafetyevaluationofpesticidesinthe

world(Overview)○ Mie AKANUMA

Safety Research Center, KUREHA CORPORATION

Program

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15:04 - 15:27S17-2 NewApproachesforRefiningtheOccupationalExposureRisk

AssessmentintheEuropeanUnion○ Rieko ISHIKAWA1, Gary DEAN2, Javier BARTOLOME2, Hyacinth CHIN SUE2, Adele JONES2, Hayley BIGNELL2

1Labcorp Development Japan K.K., 2Labcorp Early Development Laboratories Limited

15:27 - 15:50S17-3 Pesticidesafetyassessmentthroughdrinkingwaterinhumans

○ Toru SUGIYAMA Nissan Chemical Corporation

15:50 - 16:13S17-4 Currentsituationofenvironmentalriskassessmentandeffortsto

developeco-friendlyagrochemicals○ Jun MAEDA

NIHON NOHYAKU CO., LTD.

16:13 - 16:36S17-5 SafetyassessmentforCMR

○ Kosei INUI Ishihara Sangyo Kaisha, Ltd.

16:36 - 16:59S17-6 Safetyassessmentforendocrinedisruptors

○ Takafumi YAMAGUCHI SUMITOMO CHEMICAL Co., Ltd.

16:59 - 17:00Conclusion

Symposium18 July 8 (Thu) 15:00 - 17:00Room 3

Nephrotoxicity-fromthestandpointofclinicalpharmacistandbasicresearch-Chair: Daigo SUMI (Faculty of Pharmaceutical Sciences, Tokushima Bunri University)

15:00 - 15:30S18-1 Conceptofbloodpurificationtherapyandexperienceof

renaltoxicityinclinical○ Toshiro SHIUCHI

Department of Pharmacy, Kawashima Hospital

15:30 - 16:00S18-2 Theimportanceof“interest”inpreventingofdrug-induced

kidneyinjuryinclinicalpractice○ Taku FURUKUBO

Department of Hospital Pharmacy, Shirasagi Hospital

16:00 - 16:30S18-3 Proximaltubularregion-specifictoxicityofcisplatinand

investigationofitsmechanism○ Hitomi FUJISHIRO1, Hiroki TAGUCHI1, Seiichiro HIMENO1, 2, Akihiro UEHARA3, Shino TAKEDA3, Daigo SUMI1

1Laboratory of Molecular Nutrition and Toxicology, Faculty of Pharmaceutical Sciences, Tokushima Bunri University, 2Faculty of Pharmaceutical Sciences, Showa University, 3National Institutes for Quantum and Radiological Science and Technology

Program

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16:30 - 17:00S18-4 Renaltoxicityscreeninginearly-stagedrugdiscovery

○ Masanori HIZUE Pfizer R&D Japan

Symposium19 July 8 (Thu) 15:00 - 17:00Room 4

Prevalenceofcomputationaltoxicologyforpharmaceutical: CasestudyforSystemconstructionunderontologyChairs: Hajime KOJIMA (National Institute of Health Sciences)

Shoji ASAKURA (Global Drug Safety, Eisai Co., Ltd)

15:00 - 15:20S19-1 IntroductoryRemarks:Computationaltoxicologyformechanistic

interpretationindrugsafetyassessment○ Ikuo HORII

Pfizer

15:20 - 15:45S19-2 DatasharingandpredictionofdrugefficacyandADMETusingAI

○ Yasushi OKUNO Department of Biomedical Data Intelligence, Graduate School of Medicine, Kyoto University

15:45 - 16:10S19-3 UtilizationofOntologicalThinkingtoComputationalToxicology

○ Yuki YAMAGATA Laboratory for Developmental Dynamics, RIKEN Center for Biosystems Dynamics Research

16:10 - 16:35S19-4 DevelopmentofAImutagenicitypredictionsystemincorporatingthe

knowledgeofexpertreview○ Naoki KOYAMA1, Megumi IKEMORI2, Tomoki NISHIOKA3, Seiji HITAOKA3, Atsushi HAKURA1, Chihiro NAKAZAWA1, Chakravarti K SUMAN4, Saiakhov D ROUSTEM4, Shinada K NICOLAS5, Palaniappan K SUCHEENDRA5, Yukiko MATSUOKA5, Shoji ASAKURA1

1Global Drug Safety, Eisai Co., Ltd., 2Planning & Operation. hhc Data Creation Center, Eisai Co., Ltd., 35D Integration Unit, hhc Data Creation Center, Eisai Co., Ltd., 4MultiCASE Inc., 5SBX Corporation

16:35 - 17:00S19-5 Applicationofcomputationaltoxicologyattheearly-stageofdrug

discovery○ Hideto HARA

Drug Safety Research and Evaluation, Takeda Pharmaceutical Company Limited

Program

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Symposium20 July 8 (Thu) 15:00 - 17:00Room 5

JSOT-JCAJointSymposium:Molecularbasisandperspectiveforcarcinogenicityassessment:humanextrapolationbaseduponmutationsignatureandepigenomeChairs: Toshikazu USHIJIMA (Division of Epigenomics, National Cancer Center Research Institute)

Jun KANNO (National Institute of Health Sciences)

15:00 - 15:03Introduction

15:03 - 15:33S20-1 Evaluationofepigenomictoxicity

○ Toshikazu USHIJIMA, Naoko HATTORI Division of Epigenomics, National Cancer Center Research Institute

15:33 - 16:03S20-2 Carcinogenesisasseenfromthemutationsignature

○ Shumpei ISHIKAWA Department of Preventive Medicine, Graduate School of Medicine, The University of Tokyo

16:03 - 16:33S20-3 Percellometranscriptomicsanalysisonsomecarcinogensfortheir

epigeneticcharacteristics○ Ken-ichi AISAKI, Ryuichi ONO, Jun KANNO, Satoshi KITAJIMA

Division of Cellular and Molecular Toxicology, Center for Biological Safety and Research, National Institute of Health Sciences

16:33 - 17:00S20-4 Characteristicsoftranscriptomicsoftheforeign-bodycarcinogenesis

○ Jun KANNO, Atsuya TAKAGI, Ken-ichi AISAKI, Satoshi KITAJIMA National Institute of Health Sciences, Division of Cellular and Molecular Toxicolog7, CBSR.

Symposium21 July 9 (Fri) 9:00 - 11:00Room 2

ACT/JSOTJointSession:NonvaccineTherapeuticInterventionsforCOVID-19Chairs: Kazushige MAKI (PMDA)

Hideo FUKUI (Axcelead Drug Discovery Partners, Inc.)

9:00 - 10:00S21-1 Remdesivir:ADirectActingAntiviralfortheTreatmentofCOVID-19

○ Roy BANNISTER Gilead Sciences, Foster City, CA

10:00 - 11:00S21-2 PreclinicalConsiderationsforCellandGeneTherapiesforCOVID-19

○ Daniel J URBAN United States Food and Drug Administration, Center for Biological Evaluation and Research, Office of Tissues and Advanced

Therapies

Program

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Symposium22 July 9 (Fri) 9:00 - 11:00Room 4

SpeciesdifferencesinxenobioticsmetabolismanddetoxificationChairs: Mayumi ISHIZUKA (Laboratory of Toxicology, Faculty of Veterinary Medicine, Hokkaido University)

Yasuhiro UNO (Kagoshima University, Joint Faculty of Veterinary Medicine)

9:00 - 9:15S22-1 Speciesdifferencesinxenobioticsmetabolismanddetoxification

-introduction-○ Mayumi ISHIZUKA, Shouta NAKAYAMA, Yoshinori IKENAKA

Laboratory of Toxicology, Faculty of Veterinary Medicine, Hokkaido University

9:15 - 9:40S22-2 Metabolismofxenobioticsininsects

○ Koji YAMAMOTO Department of Agriculture, Kyushu University Graduate School

9:40 - 10:05S22-3 Speciesdifferencesandevolutionofgenesinvolvedinxenobiotic

metabolism(cytochromeP450,glucuronosyltransferase)inbirds○ Yusuke K. KAWAI

Department of Veterinary Medicine, Obihiro University of Agriculture and Veterinary Medicine

10:05 - 10:30S22-4 Functionandevolutionofbittertastereceptorsasthetoxinsensor

○ Takashi HAYAKAWA1, 2

1Group of Ecological Genetics, Section of Environmental Biology, Faculty of Environmental Earth Science, Hokkaido University, 2Japan Monkey Centre

10:30 - 10:55S22-5 Identificationandanalysisofdrug-metabolizingenzymesincynomolgus

macaques○ Yasuhiro UNO1, Hiroshi YAMAZAKI2

1Joint Faculty of Veterinary Medicine, Kagoshima University, 2Showa Pharmaceutical University

10:55 - 11:00Conclusion

Symposium23 July 9 (Fri) 9:00 - 11:00Room 5

MolecularbasisofpathogenesisinpulmonarytoxicityChairs: Yuhji TAQUAHASHI ( Division of Cellular & Molecular Toxicology, Center for Biological Safety & Research,

National Institute of Health Sciences)Naozumi ISHIMARU ( Department of Oral Molecular Pathology, Tokushima University Graduate School of

Biomedical Sciences)

9:00 - 9:04Introduction

9:04 - 9:32S23-1 Rolesofsignalandtranscriptionalnetworkduringthemaintenanceof

lymphaticvessels○ Tetsuro WATABE

Tokyo Medical and Dental University

Program

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9:32 - 10:00S23-2 Molecularbasisofpulmonaryfibrosisbygenomeanalysisoffamilial

pulmonaryfibrosis○ Koji YASUTOMO

Department of Immunology, Tokushima University

10:00 - 10:28S23-3 PulmonaryImmuneResponseandMolecularMechanismofFibrosisby

InhalationExposuretoNanomaterials○ Naozumi ISHIMARU1, Rieko ARAKAKI1, Takaaki TSUNEMATSU1, Yuhji TAQUAHASHI2, Jun KANNO2

1Department of Oral Molecular Pathology, Tokushima University Graduate School of Biomedical Sciences, 2Division of Cellular Molecular Toxicology, National Institute of Health Sciences

10:28 - 10:56S23-4 Transcriptomicresponsesofthelungtovolatilechemicalsandtheir

mechanistictoxicityprediction○ Jun KANNO1, Satoshi KITAJIMA1, Ken-ichi AISAKI1, Hirokatsu SAITO1, Kentaro TANEMURA2

1Division of Cellular and Molecular Toxicolog, CBSR, National Institute of Health Sciences, 2Laboratory of Animal Reproduction and Development, Graduate School of Agricultural Science, Tohoku University

10:56 - 11:00Conclusion

Symposium24 July 9 (Fri) 9:00 - 11:30Room 6

JSIT-JSOTJointSymposium:CurrentstatusandchallengesfortheimmunotoxicitystudiesofvariousdrugmodalitiesChairs: Yasumitsu NISHIMURA (Department of Hygiene, Kawasaki Medical School)

Kiyoshi KUSHIMA (Astellas Pharma)

9:00 - 9:03Introduction

9:03 - 9:32S24-1 Developmentofanext-generationadenovirusvectorcontaining

miRNA-mediatedpost-transcriptionalgenesilencingsystemandelucidationofadenovirusvector-inducedhepatotoxicity○ Fuminori SAKURAI1, Hiroyuki MIZUGUCHI1, 2, 3, 4

1Laboratory of Biochemistry and Molecular Biology, Graduate School of Pharmaceutical Sciences, Osaka University, 2Laboratory of Hepatocyte Regulation, National Institutes of Biomedical Innovation, Health and Nutrition, 3The Center for Advanced Medical Engineering and Informatics, Osaka University, 4Integrated Frontier Research for Medical Science Division, Institute for Open and Transdisciplinary Research Initiatives, Osaka University

9:32 - 10:01S24-2 Considerationforsafetyassessmentofinnateimmunityactivationby

oligonucleotidetherapeutics○ Takao INOUE

Division of Molecular Target and Gene Therapy Products, National Institute of Health Sciences

Program

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10:01 - 10:30S24-3 Immunogenicityassessmentandde-immunizationduringthe

developmentofantibodytherapeutics○ Chiyomi KUBO

Chugai Pharmaceutical Co., Ltd., Research Division

10:30 - 10:59S24-4 Issuesinquality,efficacyandsafetyevaluationofmesenchymalstem

cellprocessedproductsusedforcelltherapy○ Rumi SAWADA

Division of Cell-Based Therapeutic Products, National Institute of Health Sciences

10:59 - 11:28S24-5 Immunotoxicologyassessmentofvaccinesandadjuvants

innon-humanprimatemodel○ Takuya YAMAMOTO

Laboratory of Immunosenescence, National Institutes of Biomedical Innovation, Health and Nutrition

11:28 - 11:30Conclusion

Symposium25 July 9 (Fri) 10:10 - 12:10Room 7

BiometalsSpecialtySectionSymposium-NewDevelopmentofMetallothioneinFunction-Chairs: Masahiko SATOH (School of Pharmacy, Aichi Gakuin University)

Yasuyuki FUJIWARA ( Department of Environmental Health, School of Pharmacy, Tokyo University of Pharmacy and Life Sciences)

10:10 - 10:16Introduction

10:16 - 10:43S25-1 Roleofmetallothioneinincadmiumtoxicitytovascularendothelialcells

○ Tomoya FUJIE1, Toshiyuki KAJI2, Chika YAMAMOTO1

1Faculty of Pharmaceutical Sciences, Toho University, 2Faculty of Pharmaceutical Sciences, Tokyo University of Science

10:43 - 11:10S25-2 Dopaminergicneuroprotectionbytargetingmetallothioneinexpression

inastrocytes○ Ikuko MIYAZAKI, Masato ASANUMA

Department of Medical Neurobiology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences

11:10 - 11:37S25-3 Metallothionein-IprotectsagainstpathologicalaggregationofSOD1

associatedwithamyotrophiclateralsclerosis○ Eiichi TOKUDA1, Maiko KEIMA1, Chiako IKEDA1, Shin-ichi ONO1, 2

1School of Pharmacy, Nihon University, 2Devison of Neurology, Akiru Medical Center

11:37 - 12:04S25-4 Unravelingofredoxregulationofmetallothioneinbysulfanesulfur

○ Yasuhiro SHINKAI, Yoshito KUMAGAI Environmental Biology Lab, Faculty of Medicine, University of Tsukuba

Program

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12:04 - 12:10Conclusion

Symposium26 July 9 (Fri) 14:40 - 16:40Room 2

CaseReport“HumanClinicalPredictabilityofToxicitySeeninNonclinicalstudies”Chairs: Hisaharu YAMADA (Taisho Pharmaceutical Co., Ltd.)

Akio KOBAYASHI (Toxicology Research Laboratories, Central Pharmaceutical Research Institute, Japan Tobacco Inc.)

14:40 - 14:48Introduction

○ Hisaharu YAMADATaisho Pharmaceutical Co., Ltd.

14:48 - 15:14S26-1 Casestudiesoftranslationalresearchofnonclinicaltoxicityfindings

insmallmoleculedrugdevelopments○ Kotaro TAMURA

Drug Safety Research Labs. Astellas Pharma Inc.

15:14 - 15:40S26-2 ExtrapolationofNonclinicalCardiovascularStudyDatatoHuman

–AnExampleofthe5-HT4ReceptorAgonist–○ Tadashi TSUBOUCHI, Kazuhiro CHIHARA, Izuru MIYAWAKI

Preclinical Research Unit, Drug Research Division, Sumitomo Dainippon Pharma Co., Ltd.

15:40 - 16:06S26-3 Difficultytopredicthumanadverseeventbasedonthenon-clinical

toxicologystudy○ Tamio FUKUSHIMA

Shionogi Co&Ltd

16:06 - 16:32S26-4 Extrapolationofpseudo-allergicreactionsseeninthedogtoxicitystudy

tohumans-EvaluationbyusingMRGPRX2-expressedcells-○ Koichi GOTO, Eri HAMAMURA, Kazunori FUJIMOTO, Kazuhiko MORI

Medicinal Safety Research Laboratories, Daiichi Sankyo Co., Ltd.

16:32 - 16:40Conclusion

○ Akio KOBAYASHIToxicology Research Laboratories, Central Pharmaceutical Research Institute, Japan Tobacco Inc.

Program

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Symposium27 July 9 (Fri) 14:00 - 16:00Room 4

SafetyassessmentforregenerativemedicineChairs: Yoji SATO (Division of Cell-Based Therapeutic Products, National Institute of Health Sciences)

Tadahiro SHINOZAWA (Takeda Pharmaceutical Company Limited)

14:00 - 14:30S27-1 DomesticandInternationalTrendsinNon-ClinicalSafetyEvaluationof

CellTherapyProducts○ Yoji SATO

Division of Cell-Based Therapeutic Products, National Institute of Health Sciences

14:30 - 15:00S27-2 Non-clinicalsafetyassessmentforhumancelltherapyproducts

inPMDA○ Mizuho NONAKA

Pharmaceuticals and Medical Devices Agency

15:00 - 15:30S27-3 DevelopmentofiPSC-derivedimmunecell-basedcancer

immunotherapy,fromtheaspectofnon-clinicalsafetytests○ Shin KANEKO

Center for iPS cell Research and Application (CiRA), Kyoto University

15:30 - 16:00S27-4 DiscoveryToxicologyStrategyforSaferCellTherapies

○ Matthew WAGONER, Tadahiro SHINOZAWA Drug Safety Research and Evaluation, Takeda Pharmaceuticals

Symposium28 July 9 (Fri) 14:00 - 16:00Room 5

JSCT-JSOTJointSymposium:Basicstudyandclinicalapplicationoftheposioningduetoinhaleddrugsand/orinhalableformulationsChairs: Manabu SUGITA (Dept. of Emergency and Critical Care Medicine, Juntendo University Nerima Hospital)

Satoshi KITAJIMA ( Division of Cellular & Molecular Toxicology, Center for Biological Safety & Research, National Institute of Health Sciences)

14:00 - 14:30S28-1 Innovationininhalations:Applicationtoinhalablegenepowders

○ Hirokazu OKAMOTO, Tomoyuki OKUDA Department of Drug Delivery Research, Faculty of Pharmacy, Meijo University

14:30 - 14:55S28-2 Novelimagingtechnologiesfordevelopmentofinhalants

○ Eiichi YAMAMOTO, Yuhji TAQUAHASHI Division of Drugs, National Institute of Health Sciences

Program

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14:55 - 15:20S28-3 ○ Mitsuo OHNISHI

Department of Acute Medicine & Critical Care Medical Center, National Hospital Organization Osaka National Hospital

15:20 - 15:45S28-4 Poisoningcausedbyinhalation:Reportfromanemergencydepartment

○ Yasuo HIROSE Department of Emergency Medicine, Niigata City General Hospital

15:45 - 16:00Discussion

Symposium29 July 9 (Fri) 13:30 - 15:30Room 6

NextGenerationResearchSeminar:MicrobiomeandToxicologyChairs: Yuhji TAQUAHASHI ( Division of Cellular & Molecular Toxicology, Center for Biological Safety & Research,

National Institute of Health Sciences)Yasuyuki FUJIWARA ( Department of Environmental Health, School of Pharmacy, Tokyo University of Pharmacy

and Life Sciences)

13:30 - 13:34Introduction

13:34 - 14:02S29-1 Humanmicrobiomeinhealthanddisease

○ Shinji FUKUDA1, 2, 3, 4

1Institute for Advanced Biosciences, Keio University, 2KISTEC-KAST, 3University of Tsukuba School of Medicine, 4Metabologenomics, Inc

14:02 - 14:30S29-2 Bacterialcompositionoforalindigenousmicrobiotaanditsrelationship

withhealthanddiseases○ Toru TAKESHITA1, 2

1Section of Preventive and Public Health Dentistry, Faculty of Dental Science, Kyushu University, 2OBT Research Center, Faculty of Dental Science, Kyushu University

14:30 - 14:58S29-3 Akeygeneticfactorforfucosyllactoseutilizationaffectsinfantgut

microbiotadevelopment○ Takahiro MATSUKI

Yakult Central Institute

14:58 - 15:26S29-4 GutmicrobiotaandLiverdisease:Hepaticencephalopathy

○ Naoko OHTANI Department of Pathophysiology, Graduate School of Medicine, Osaka City University

15:26 - 15:30Conclusion

Program

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WorkshopWorkshop1 July 8 (Thu) 10:40 - 12:10

Room 3

TheperspectiveonGLPoperationinthe"NewNormal"Chairs: Yoshinobu HIRAYAMA (Japan Society of Quality Assurance)

Mutsumi SUZUKI (Toxicological Research Laboratories, Translational Research Unit, R&D Division Kyowa Kirin Co., Ltd.)

10:40 - 11:00W1-1 RecentstateofGLPissuesindomesticandoverseascountries

○ Kanako ITO Office of Non-clinical and Clinical Compliance, Pharmaceuticals and Medical Devices Agency

11:00 - 11:15W1-2 EnsuringReliability-PointstobeRecordedinMicroscopicInspection-

○ Nobuhide TSURUMAKI Leica Microsystems K.K.

11:15 - 11:30W1-3 AIdrugdiscoverybringsNewNormalofSafetytest

○ Kazumi HAKAMADA LPIXEL Inc.

11:30 - 11:50W1-4 DataIntegritytreatinginhomeworkinginvolvingGLP

○ Yoshiaki HIRAISHI Evaluation Center, TERUMO CORPORATION (Japan Society of Quality Assurance)

11:50 - 12:10W1-5 Asurveyonchangesofon-siteworkinGLPstudieswithnewnormal

○ Satoshi TSUJI1, 2, Asuka TAKUMI1, 3, Akira KODA1, 4, Koki YAMAGUCHI1, 5, Terutaka KODAMA1, 6

1Safety Evaluation Forum, 2Taisho Pharmaceutical Co., Ltd., 3Ajinomoto Co., Inc., 4Maruho Co., Ltd., 5Japan Tobacco Inc., 6EA Pharma Co., Ltd.

Workshop2 July 8 (Thu) 9:00 - 10:30Room 7

NewaspectofspecificexternalexposomestudyChairs: Takashi UEHARA ( Department of Medicinal Pharmacology, Graduate School of Medicine, Dentistry, and

Pharmaceutical Sciences, Okayama University)Yasunari KANDA (Division of Pharmacology, National Institute of Health Sciences)

9:00 - 9:02Introduction

9:02 - 9:19W2-1 Biologicalhomeostaticmechanismviaantioxidativefood-derived

adductformation○ Masanori ITAKURA, Koji UCHIDA

Graduate School of Agricultural and Life Sciences, The University of Tokyo

Program

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9:19 - 9:36W2-2 Lysineadductexposomebycarboxylicacidsinfood

○ Akihiro ITO School of Life Sciences, Tokyo University of Pharmacy and Life Sciences

9:36 - 9:53W2-3 Oxidativestressexposomeasaspecificexternalexposome

○ Yumi ABIKO, Yoshito KUMAGAI Faculty of Medicine, University of Tsukuba

9:53 - 10:10W2-4 Applicationofmassspectrometryandinformaticstoexposomes

○ Naoshi DOHMAE RIKEN Center for Sustainable Resource Science

10:10 - 10:27W2-5 AnalysisofProteinModificationsbyUsingDirectDetectionof

AlkyneTag○ Kosuke DODO1, 2

1RIKEN Cluster for Pioneering Research, 2RIKEN Center for Sustainable Resource Science

10:27 - 10:30Conclusion

Workshop3 July 8 (Thu) 10:40 - 12:10Room 7

NonclinicalSafetyAssessmentofPharmaceuticalsin2035:AlternativestoAnimalExperimentsChairs: Dai KAKIUCHI (Eisai Co., Ltd. Biopharmaceutical Assessment Core Function Unit, Global Drug Safety)

Takeshi SATO (Drug Safety Research Labs, Drug Discovery Research, Astellas Pharma Inc.)

10:40 - 10:43Introduction

○ Takeshi SATODrug Safety Research Labs, Drug Discovery Research, Astellas Pharma Inc.

10:43 - 11:08W3-1 Currentstatusandissuesofalternativestoanimalexperimentsusing

pharmaceuticalsafetyevaluation○ Hajime KOJIMA

Div. of Risk Assessment, National Institute of Health Sciences

11:08 - 11:28W3-2 Thecurrentsituationofinvitroevaluationmethodsforneurotoxicity

○ Takafumi SHIRAKAWA Astellas Pharma Inc.

11:28 - 11:48W3-3 Utilizationofinvitro and insilicoapproachesindevelopmentof

ophthalmicdrugs○ Ikuyo ATSUMI

Research & Development Division, Senju Pharmaceutical Co., Ltd.

11:48 - 12:08W3-4 FutureforsafetyassessmentbyMPS(Organonchips)in2035

○ Hitoshi NARAOKA Stem Cell Evaluation Technology Research Association

Program

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12:08 - 12:10Conclusion

○ Dai KAKIUCHIEisai Co., Ltd. Biopharmaceutical Assessment Core Function Unit, Global Drug Safety

Workshop4 July 8 (Thu) 15:00 - 17:00Room 6

CollaborationSessions:Let’sstartacommunicationbetweensponsorsandPMDAChairs: Kazushige MAKI (PMDA)

Mutsumi SUZUKI (Toxicological Research Laboratories, Translational Research Unit, R&D Division Kyowa Kirin Co., Ltd.)

15:00 - 15:02W4-1 Introduction

○ Kazushige MAKI1, Mutsumi SUZUKI2

1Pharmaceuticals and Medical Devices Agency, 2Kyowa Kirin Co., Ltd

15:02 - 15:31W4-2 Aquestionnairesurveyondiscussionsbetween

pharmaceuticalcompaniesandPMDAinnon-clinical safetyassessmentofpharmaceuticals○ Makoto MIYAUCHI1, Mutsumi SUZUKI2, Izuru MIYAWAKI3, Terutaka KODAMA4

1Mochida Pharmaceutical Co., Ltd., 2Kyowa Kirin Co., Ltd., 3Sumitomo Dainippon Pharma Co., Ltd., 4EA Pharma Co., Ltd.

15:31 - 16:00W4-3 Non-clinicalsafetyevaluationofavirtualdrug-

theviewofdevelopmentcompany○ Izuru MIYAWAKI

Preclinical Research Unit, Research Division, Sumitomo Dainippon Pharma Co., Ltd

16:00 - 16:29W4-4 NonclinicalSafetyEvaluationforVirtualDrugCandidates-

FromtheStandpointofRegulatoryAgency○ Jihei NISHIMURA

Pharmaceuticals and Medical Devices Agency

16:29 - 16:59Discussion

○ Satoshi TSUNODA (Pharmaceuticals and Medical Devices Agency), Chairs and Speakers

16:59 - 17:00Conclusion

Program

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Workshop5 July 8 (Thu) 15:00 - 17:00Room 7

ApplicationofnovelgastrointestinalmodelsandbiomarkersindrugdevelopmentChairs: Jumpei KIYOKAWA (Translational Research Division, Chugai Pharmaceutical Co., Ltd.)

Satoko KAKIUCHI-KIYOTA (Safety Assessment, Genentech)

15:00 - 15:06W5-1 Introduction

○ Jumpei KIYOKAWA1, Satoko KAKIUCHI-KIYOTA2

1Translational Research Division, Chugai Pharmaceutical Co., Ltd., 2Safety Assessment, Genentech

15:06 - 15:34W5-2 Applicationofintestinalorganoidsfordrugdiscovery

○ Shinpei YOSHIDA Laboratory for Drug Discovery and Development, Shionogi & Co., Ltd.

15:34 - 16:02W5-3 UtilityofaThree-DimensionalHumanSmallIntestinalModelfor

AssessingDrug-InducedGastrointestinalToxicity○ Tomomi KIYOTA

Investigative Toxicology, Department of Safety Assessment, Genentech Inc.

16:02 - 16:30W5-4 Thevalueofpotentialbiomarkersforevaluatingintestinaltoxicity

invivo○ Nozomi FUJISAWA

Chugai Pharmaceutical Co., Ltd., Translational Research Division

16:30 - 16:58W5-5 Currentstatusandprospectsofdrugdiscoverybusinessbasedon

humanmicrobiomeresearch○ Takayuki KAJIURA

Japan Microbiome Consortium

16:58 - 17:00Conclusion

○ Satoko KAKIUCHI-KIYOTASafety Assessment, Genentech

Workshop6 July 9 (Fri) 13:30 - 14:30Room 1

Reportofchemotherapy'sexperiencefromtoxicologistsascancersurvivorsChair: Kazuhiko MORI (Daiichi Sankyo RD Novare Co., Ltd.)

13:30 - 13:35Introduction

13:35 - 14:00W6-1 Asacancersurvivor

○ Yoshitaka INUI Drug Safety Research and Evaluation, Research, Takeda Pharmaceutical Company Limited

Program

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14:00 - 14:25W6-2 AdverseeffectsassociatedwithChemotherapy(pediatric

osteosarcoma)○ Shigehito TAKESHITA

Medicinal Safety Research Laboratories, Daiichi Sankyo Co., Ltd.

14:25 - 14:30Discussion

Workshop7 July 9 (Fri) 14:40 - 16:40Room 1

ScienceofcancerchemotherapyinducedsideeffectsandsupportivecareChairs: Shoji ASAKURA (Global Drug Safety, Eisai Co., Ltd)

Mutsumi SUZUKI (Toxicological Research Laboratories, Translational Research Unit, R&D Division Kyowa Kirin Co., Ltd.)

14:40 - 14:45Introduction

○ Shoji ASAKURAGlobal Drug Safety, Eisai Co., Ltd

14:45 - 15:15W7-1 Howtorecognizeanddealunexpectedadverseevents

in clinical practice○ Sadamoto ZENDA

Department of Radation Oncology

15:15 - 15:35W7-2 Basicstudyonnutritionalinterventionsfortreatingcancer

chemotherapy-inducedfatigue○ Kazumi YOSHIZAWA1, Ruka KURONO1, Haruka SATO1, Erika ISHIJIMA1, Aoi YAMANE1, Nurfarhana FERDAOS1, 2, Hidetaka SUZUKI1, 3

1Laboratory of Pharamacology and Therapeutics, Faculty of Pharmaceutical Sciences, Tokyo University of Science, 2Department of Pharmacology and Chemistry, Faculty of Pharmacy, Universiti Teknologi MARA, 3Division of Pharmacy, National Cancer Center Hospital East

15:35 - 15:55W7-3 Developmentofpreventive/therapeuticdrugsforchemotherapy-induced

peripheralneuropathyandoralmucositis○ Takayuki NAKAGAWA

Department of Clinical Pharmacology and Therapeutics, Kyoto University Hospital

15:55 - 16:15W7-4 Researchofsideeffectsinanti-canceragents:Hand-footsyndrome

○ Misato TAKANO-MOCHIZUKI Global Drug Safety, Eisai Co., Ltd.

16:15 - 16:40Discussion

Program

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Workshop8 July 9 (Fri) 15:40 - 16:40Room 6

ActivecareerofToxicologists-YoucanbeanAI-PoweredToxicologist-Chairs: Yukinori AMANO (Kowa Co.,Ltd.)

Kazuhiko MORI (Daiichi Sankyo RD Novare Co., Ltd. )

15:40 - 15:44W8-1 Introduction

○ Yukinori AMANO1, 2

1JSOT Science and Publicity Committee, 2Kowa Co., Ltd.

15:44 - 16:02W8-2 RoadmapforDXPromotionintheNewEra-HowtoCreateOpportunities

forToxicologists-○ Daichi ISHII

STANDARD, Inc.

16:02 - 16:20W8-3 AIengineersdon'tknowtoxicology -Fillthegapbetweenengineersand

maximizetheeffectofAIutilization-○ Tomoya SOMA1, 2

1Medicinal Hub,Graduate School of Medicine, Tohoku University, 2NEC Corporation

16:20 - 16:40Discussion

Program

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Program

AwardLectureAwardLecture July 8 (Thu) 15:10 - 16:40

Room 1

TheJSOTAwardChair: Mamoru MUTAI (LSIM Safety Institute Corporation)

AWL1 Researchonthedevelopmentofquantitativeassessmentmethodsfor

administrativeuse○ Akihiko HIROSE

National Institute of Health Sciences

TheTetsuoSatohAwardChair: Akihiko HIROSE (National Institute of Health Sciences)

AWL2 AcademicPromotionofInternationalStandardsandEstablishmentof

ToxicologistCertificationSystemoftheJapaneseSocietyofToxicology○ Yuji KUROKAWA

SASAKI FOUNDATION

TheJSOTYoungScientistAwardChair: Tsuyoshi YOKOI (Nagoya University Graduate School of Medicine)

AWL3 Analysisofmechanisms,explorationofbiomarkers,anddevelopment

ofacell-basedassayfordrug-inducedliverinjury○ Shingo ODA

Safety Research Laboratories, Discovery and Research, Ono Pharmaceutical Co., Ltd.

Pleaserefertopage57-60forotherawards(TanabeAward,PfizerAward,OutstandingTechnologyAwardandTheJCIALRIAward).

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Candidates for the Excellent Presentation Award (Oral)

Candidates for the Excellent Presentation Award (Oral) 1 July 7 (Wed) 10:30 - 12:00Room 7

Chairs: Yuhji TAQUAHASHI ( Division of Cellular & Molecular Toxicology, Center for Biological Safety & Research, National Institute of Health Sciences)

Hideshi TSUSAKI (SNBL, Ltd)Pharmaceutical drugs (chemicals)P-1E Evaluationofdifferencesofstructurallysimilarcompoundswith

decompositionanalysisofchemicalprofiledata○ Tadahaya MIZUNO, Katsuhisa MORITA, Shumpei NEMOTO, Hiroyuki KUSUHARA

Molecular Pharmacokinetics, Pharmaceutical Sciences, The University of Tokyo

Agricultural chemicalsP-2E Neurotoxicityofapyrethroidpesticidedeltamethrinmediatedby

imbalanceofproteolyticsystems○ Tetsushi HIRANO1, Nihei SUZUKI1, Yoshinori IKENAKA2, Nobuhiko HOSHI3, Yoshiaki TABUCHI1

1Life Science Research Center, University of Toyama, 2Translational Research Unit, Veterinary Teaching Hospital, Faculty of Veterinary Medicine, Hokkaido University, 3Laboratory of Animal Molecular Morphology, Department of Animal Science, Graduate School of Agricultural Science, Kobe University

NanomaterialsP-33E Comparativetoxicityandcarcinogenicitypulmonarystudyof

double-walledcarbonnanotubes(DWCNT)withmulti-walledcarbonnanotubes-7(MWCNTS-7)inaratmodel○ Dina M. SALEH1, 2, 3, Shengyong LUO5, David B. ALEXANDER1, Ahmed M. EL-GAZZAR7, Mohammed ABDELGAIED6, Omnia H. MOHAMMED1, 2, 4, Willim T. ALEXANDER1, Sivagami GUNASEKARAN1, Takamasa NUMANO1, Hiroshi TAKASE8, Makoto OHNISHI9, Satoru TAKAHASHI2, Hiroyuki TSUDA1

1Nanotoxicology Lab Project, Nagoya City University, Nagoya, Japan, 2Departement of Experimental Pathology and Tumor Biology, Graduate School of Medicine, Nagoya City University, Nagoya, Japan, 3Departement of Forensic Medicine and Clinical Toxicology, Faculty of Medicine, Assuit University, Assuit, Egypt, 4Departement of Forensic Medicine and Clinical Toxicology, Faculty of Medicine, Aswan University, Aswan, Egypt, 5Anhui Medical University, College of Basic Medical Sciences, Hefei, China, 6Departement of Forensic Medicine and Toxicology, Faculty of Veterinary Medicine, Beni-suef University, Beni-suef, Egypt, 7Departement of Forensic Medicine and Toxicology, Faculty of Veterinary Medicine, Alexandria University, Alexandria, Egypt, 8Core Laboratory, Graduate School of Medicine, Nagoya City University, Nagoya, Japan, 9Japan Industrial Safety and Health Association, Japan Bioassay Research Center, Hadano, Kanagawa, Japan

Program

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NervoussystemP-36E Effectsofparticlematter2.5(PM2.5)exposureontheprognosisof

ischemic stroke in mice○ Miki TANAKA1, Ami OGURO1, Yu NABETANI2, Tomoaki OKUDA3, Kouichi ITOH4, Yasuhiro ISHIHARA1

1Program of Biomedical Science, Graduate School of Integrated Sciences for Life, Hiroshima University, 2Department of Applied Chemistry, University of Miyazaki, 3Department of Applied Chemistry, Faculty of Science and Technology, Keio University, 4Laboratory for Pharmacotherapy and Experimental Neurology, Kagawa School of Pharmaceutical Sciences, Tokushima Bunri University

P-37E DetectionofbrainfunctiondisruptioncausedbynicotinicacetylcholinereceptoragonistsusingCa2+imagingwithtwo-photonmicroscopy○ Anri HIRAI1, Shouta SUGIO2, Collins NIMAKO1, Shouta M.M. NAKAYAMA1, Keisuke KATO3, Keisuke TAKAHASHI3, Koji ARIZONO4, Tetsushi HIRANO5, Nobuhiko HOSHI6, Kazutoshi FUJIOKA7, Kumiko TAIRA8, Mayumi ISHIZUKA1, Hiroaki WAKE2, Yoshinori IKENAKA1, 9

1Laboratory of Toxicology, School of Veterinary Medicine, Hokkaido University, 2Department of Anatomy and Molecular Cell Biology, Graduate School of Medicine, Nagoya University, 3Faculty of Pharmaceutical Sciences, Toho University, 4Faculty of Environmental and Symbiotic Sciences, Prefectural University of Kumamoto, 5Life Science Research Center, University of Toyama, 6Student Affairs Section, Graduate School of Agricultural Science, Kobe University, 7Albany College of Pharmacy and Health Sciences, 8Department of Anaesthesiology, Medical Center East, Tokyo Women’s Medical University, 9Water Research Group, Unit for Environmental Sciences and Management, North-West University

P-39E DevelopmentofAIforpredictingseizureliabilityofdrugsinelectroencephalographyusingfrequencyintensitydistributionimages○ Naoki MATSUDA1, Kenichi KINOSHITA2, Ai OKAMURA2, Takafumi SHIRAKAWA2, Ikuro SUZUKI1

1Tohoku Institute of Technology, Graduate School of Engineering., 2Drug Safety Research Lab., Astellas Pharma Inc.

P-40E Approachestoneurotoxicologyassessmentbasedondetailedpropagationpatternsinacutebrainslices○ Shuhei NOJI, Naoki MATSUDA, Ikuro SUZUKI

Department of Electronics, Tohoku Institute of Technology

LiverP-44E Studyonthemechanismoffattyliverimprovementbynicotinamidein

non-alcoholicfattyliver(NAFL)modelanimals○ Chie YOKOUCHI1, 3, Yukari NISHIMURA2, Hirohiko GOTO2, Makoto SATO2, Yuya HIDOH1, Kenji TAKEUCHI1, Yuji ISHII3

1Department of Drug Metabolism and Pharmacokinetics, Nonclinical Research Center,Tokushima Research Institute, Otsuka Pharmaceutical Co., Ltd, 2Department of Drug Safety, Nonclinical Research Center,Tokushima Research Institute, Otsuka Pharmaceutical Co., Ltd, 3Division of Pharmaceutical Cell Biology, Graduate School of Pharmaceutical Sciences, Kyushu University

Program

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P-48E Evaluationofdrugmetabolismanddrug-inducedtoxicityusingpolydimethylsiloxane-basedliver-on-a-chip○ Sayaka DEGUCHI1, 2, Masahiro TSUDA3, Kaori KOSUGI1, Hiroyuki MIZUGUCHI2, Fumiyoshi YAMASHITA3, Yu-suke TORISAWA4, Kazuo TAKAYAMA1

1Center for iPS Cell Research and Application, Kyoto University, 2Graduate School of Pharmaceutical Sciences, Osaka University, 3Graduate School of Pharmaceutical Sciences, Kyoto University, 4Graduate School of Engineering, Kyoto University

ReproductivesystemP-69E Risk assessment of AAV transmission to the next generation-in-situ

hybridizationusinggonadaltissuesofmonkeysadministeredin-houseAAV-○ Naoko OTANI, Yudai WATANABE, Kou OMURA

Astellas Pharma Inc

OtherorgansorsystemP-72E Detailedinvestigationofbonemarrowtoxicityinducedbyanticancer

drugs in various animals○ Yoko NISHINO1, Yuko NAGAYAMA1, Yukiko MIYAJIMA2, Yosuke NAKATANI2, Haruka NISHIYA3, Naomi WAKAYAMA2, Etsuko OHTA1, Shoji ASAKURA1

1Global Drug Safety, Eisai Co., Ltd., 2Global Drug Metabolism and Pharmacokinetics, Eisai Co., Ltd., 3Tsukuba R&D Supporting Division, Sunplanet Co., Ltd.

ReproductiveanddevelopmentaltoxicologyP-87E Maternalexposureeffectofglyphosateandglyphosate-basedherbicide

onhippocampalneurogenesisinrats○ Ryota OJIRO1, 2, Hiromu OKANO1, 2, Kazumi TAKASHIMA1, 2, Yasunori TAKAHASHI1, 2, Qian TANG1, 2, Satomi KIKUCHI1, 2, Toshinori YOSHIDA1, 2, Makoto SHIBUTANI1, 2

1Laboratory of Veterinary Pathology, Tokyo University of Agriculture and Technology, 2Cooperative Division of Veterinary Sciences, Graduate School of Agriculture, Tokyo University of Agriculture and Technology

P-89E Twenty-eight-dayrepeatedoraldosesofethanoldecreaseneuralstemcellstosuppressdifferentiationtoneuralprogenitorcellsaswellasreducedsynapticplasticityinadulthippocampalneurogenesisofpostpubertalrats○ Yasunori TAKAHASHI1, 2, Saori SHIMIZU1, Natsuno MAEDA1, Hiromu OKANO1, 2, Kazumi TAKASHIMA1, 2, Ryota OJIRO1, 2, Qian TANG1, 2, Satomi KIKUCHI1, 2, Toshinori YOSHIDA1, 2, Makoto SHIBUTANI1, 2

1Laboratory of Veterinary Pathology, Tokyo University of Agriculture and Technology, 2Cooperative Division of Veterinary Sciences, Graduate School of Agriculture, Tokyo University of Agriculture and Technology

Program

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CarcinogenicityP-103E Investigationsofthemechanismsofacetamide-induced

hepatocarcinogenesisbasedontheratstraindifferencesofcarcinogenicity○ Kenji NAKAMURA1, 2, Yuji ISHII1, Tsuyoshi KAWAKAMI3, Maiko TAHARA3, Shinji TAKASU1, Moeka NAMIKI1, Makoto SHIBUTANI2, Kumiko OGAWA1

1Division of Pathology, National Institute of Health Sciences, 2Laboratory of Veterinary Medicine, Tokyo University of Agriculture and Technology, 3Division of Environmental Chemistry, National Institute of Health Sciences

BehavioraltoxicologyP-106E Anattempttodetectpsychiatricadverseeventsbyevaluationofsocial

behaviorofpair-housingdogslivinginEUROGuide-compliantcages○ Miho MUKAI, Tamio FUKUSHIMA, Yoshiji ASAOKA, Yuuki KATOU

Laboratory for Drug Discovery and Development, Shionogi & CO.,LTD.

Candidates for the Excellent Presentation Award (Oral) 2 July 7 (Wed) 14:50 - 16:14Room 7

Chairs: Makoto SHIBUTANI (Laboratory of Veterinary Pathology, Tokyo University of Agriculture and Technology)Toyohiko AOKI (DIMS Institute of Medical Science, Inc.)

CellularresponseP-133E AroleofPGRMC1,membrane-boundhemeprotein,oninductionof

ferroptosis○ Kazuma HIGASHISAKA1, Ying LIN1, Sachiyo HANAMURO1, Kohei IZUSAWA1, Hiroto KONISHI1, Yuya HAGA1, Hirofumi TSUJINO1, Kazuya NAGANO1, Yasuo TSUTSUMI1, 2

1Laboratory of Toxicology and Safety Science, Graduate School of Pharmaceutical Sciences, Osaka University, 2Global Center for Medical Engineering and Informatics, Osaka University

BiomarkersP-139E HistopathologicalexaminationandevaluationofcirculatingmiRNAs

asbiomarkersofpancreatictoxicityusingacutepancreatitismodelsinmice○ Seiichiro KURASHIGE1, Yuko TOGASHI1, Naomi MATSUTANI1, Masahiko KANEKO1, Yasuteru OTAGIRI1, Toyohiko AOKI2, Terutaka KODAMA1

1Research Institute, EA Pharma Co., Ltd., 2DIMS Institute of Medical Science, Inc.

Toxicity-testingmethodsP-145E Usefulnessofthepulseoximetermethodfortheevaluationofheartrate

in conscious rats○ Daigo IMOTO, Kenta WATANABE, Tadashi TSUBOUCHI, Kazuhiro CHIHARA, Izuru MIYAWAKI

Preclinical Research Unit, Sumitomo Dainippon Pharma Co., Ltd.

Program

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P-146E Evaluationofnewinvitroscreeningsystemtodetectdrug-inducedliverinjurybyusingnewcultureplatewithlowdrugadsorptionandhighoxygenpermeability○ Akinori TAKEMURA1, Sanae ISHII1, Hiroshi MIYASAKO2, Koji WAKABAYASHI2, Katsuhiro ESASHIKA2, Takashi KOUZEKI2, Tomohiro MATSUGI2, Toru HORIE3, Kousei ITO1

1Laboratory of Biopharmaceutics, Graduate School of Pharmaceutical Sciences, Chiba University, 2Mitsui Chemicals, Inc., 3DeThree Research Laboratories

P-149E LowdensitycellcultureenhancestheformationoftightjunctionandhepaticfunctioninHepG2cells○ Rieko TANAKA1, Kazuko AIZAWA1, Manami ISO1, Kie SHIMIZU1, 2, Kazuaki NAKAMURA1

1National Center for Child Health and Development, 2Graduate School of Science and Engineering, Saitama University

P-151E NephrotoxicitypredictionsystemusinghumanESandiPScells○ Hironori OTSUKI1, 2, Junko YAMANE2, Koji INOMATA1, Ayako MIWA1, Teppei SHIOJI1, Tetsuro ARAKI1, Masanori HIURA1, Wataru FUJIBUCHI2

1Toxicological Research Laboratories, Translational Research Unit, R&D Division, 2Center for iPS Cell Research and Application (CiRA), Kyoto University

P-152E Cell-basedinvitrohigh-throughputscreeningfortheevaluationofreactivemetaboliteformationpotential○ Kosuke HARADA1, Hiroshi KOHARA1, Tomoya YUKAWA1, Kouta MATSUMIYA2, Tadahiro SHINOZAWA1

1Drug Safety Research & Evaluation, Pharmaceutical Research Division, Takeda Pharmaceutical Company Limited, 2Drug Metabolism & Pharmacokinetics Research Laboratories

AnalyticalmethodP-154E SimultaneousDetectionTechniqueandChronicLow-doseAccumulation

TrendsofImidaclopridanditsMetabolitesinTissuesofC57BL/6JMice○ Collins NIMAKO1, Yoshinori IKENAKA1, 2, 8, Osei AKOTO4, Kazutoshi FUJIOKA3, Kumiko TAIRA5, Koji ARIZONO6, Keisuke KATO7, Keisuke TAKAHASHI7, Shouta M.M. NAKAYAMA1, 7, Takahiro ICHISE1, Mayumi ISHIZUKA1

1Laboratory of Toxicology, Department of Environmental Veterinary Sciences, Faculty of Veterinary Medicine, Hokkaido University, Japan, 2Water Research Group, Unit for Environmental Sciences and Management, North-West University, Potchefstroom, South Africa, 3Pharmaceutical Research Institute, Albany College of Pharmacy and Health Sciences, USA, 4Chemistry Department, Kwame Nkrumah University of Science and Technology, Ghana, 5Department of Anesthesiology, Tokyo Women’s Medical University Center East, Japan, 6Faculty of Environmental and Symbiotic Sciences, Prefectural University of Kumamoto, Japan, 7Faculty of Pharmaceutical Sciences, Toho University, Japan, 8Translational Research Unit, Veterinary Teaching Hospital, Faculty of Veterinary Medicine, Hokkaido University, Japan

Program

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Alternatives to mammalian modelsP-158E Characteristicsofsmallintestinalepithelialcellsderivedfromhuman

inducedpluripotentstemcellsandusefulnessasanin vitro model for gastrointestinaltoxicityevaluation○ Yuki IMAKURA1, Shinji MIMA1, Nao YAMAZAKI1, Seiichi MOCHIZUKI1, Akira INOMATA1, Takahiro IWAO2, Tamihide MATSUNAGA2, Kozo NAGATA1, Masahiko TANIGUCHI1

1Bio Science & Engineering Laboratory, FUJIFILM Corporation, 2Department of Clinical Pharmacy, Graduate School of Pharmaceutical Sciences, Nagoya City University

P-160E WithdrawalofExcellentPresentationAward

P-161E DevelopmentofthemethodtoidentifyadductsformedbyNAC/NALandtestsubstances,andoxidationproductsofNACinADRAreactionsolutionsbyhigh-resolutionLC-MSanalysis○ Kohei KAMIYA1, Yasushi MISAWA1, Mamoru SUGIHARA2, Megumi NAKASHIMA2, Kazuya TAKEUCHI1, Satoshi FURUKAWA1

1Nissan Chemical Corporation, 2ALBION Co., Ltd

P-166E DevelopmentofanAlternativeOralMucosalIrritationTestUsingaThree-dimensionalHumanBuccalOralMucosalModel-VerificationofCriteriaforIrritant/Non-IrritantClassification-○ Seiya AIZAWA1, Hidenori YOSHIDA2, Kazuhiko UMESHITA3, Shinichi WATANABE1, Yutaka TAKAHASHI2, Shinji SAKANE3, Hitoshi SAKAGUCHI2, Shinsuke KATAOKA1

1LION Corporation, Research & Development Headquarters, Safety Science Research Laboratories, 2Kao Corporation, R&D, Core Technology, Safety Science Research, 3Sunstar Inc., R&D Promotion Department, Safety/Analysis Laboratories

Animal modelP-167E Measurementofchemicalconcentrationsinzebrafishembryosexposed

tohuman/mammaldevelopmentaltoxicdrugs:drugdistributionandcomparisonwithhuman/mammalpharmacokineticparameters○ Tasuku NAWAJI1, 2, Naohiro MIZOGUCHI1, Masanori SEKI1, Hiroki TERAOKA2

1Chemicals Evaluation and Research Institute, Japan, 2School of Veterinary Medicine, Rakuno Gakuen University

Risk assessment and communicationP-178E WithdrawalofExcellentPresentationAward

P-187E SettingofpracticalGHS-subcategorizationcriterionforLLNA:BrdU-ELISA○ Hisako TANIGAWA, Toshio KOBAYASHI, Yosuke MAEDA, Haruka KONDO, Masahiro TAKEYOSHI

Chemicals Evaluation and Research Institute, Japan

Program

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Informationtechnology,AI,andbigdataP-191E Detectionofbehavioralchangesinbeagledogsusingaccelerometers

-Verificationofintroductionofsensingtechnologyforhigh-qualitysafetyevaluation-○ Misato TANAKA1, Takafumi SHIRAKAWA1, Tsuyoshi SAWABE3, Takashi MATSUDA3, Hitoshi NARAOKA2

1Drug Safety Research Laboratories, Drug Discovery Research, Astellas Pharma Inc., 2Drug Discovery Research, Astellas Pharma Inc., 3Advanced Informatics and Analytics, Astellas Pharma Inc.

Program

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OralSession

OralSession1 July 7 (Wed) 11:30 - 12:30Room 2

Chairs: Daigo SUMI (Faculty of Pharmaceutical Sciences, Tokushima Bunri University)Akio KOBAYASHI (Toxicology Research Laboratories, Central Pharmaceutical Research Institute, Japan Tobacco Inc.)

Oxidative stressO-1 Inductionofdrug-metabolizingenzymemRNAsbyHIFandNrf2

○ Yuki KARATSU, Rika SAKUMA, Susumu IMAOKA Department of Biomedical Chemistry, School of Science and Technology, Kwansei Gakuin University

O-2 ContributionofDHAmetabolitestothebeneficialeffectsofDHAsupplementationinthebrainsofrotenone-inducedratmodelsofParkinson’s disease○ Ami OGURO1, Yasuhiro ISHIHARA1, Susumu IMAOKA2, Takeshi YAMAZAKI1

1Program of Biomedical Science, Graduate School of Integrated Sciences for Life, Hiroshima University, 2Department of Biomedical Chemistry, School of Science and Technology Kwansei Gakuin University

O-3 StudyonthemechanismunderlyingactivationofNrf2/SKN-1andlifespanelongationinCaenorhabditiselegansbychlorogenicacid○ Ferbian M. SISWANTO, Susumu IMAOKA

Department of Biomedical Chemistry, School of Science and Technology, Kwansei Gakuin University

MechanismsoftoxicityO-4 Mechanismsoftoxicitycausedbycarbonnanotubes

○ Shin-Ichiro YAMAGUCHI1, Masanobu MORITA2, Fumiya ITO3, 4, Qilin XIE1, Shinya TOYOKUNI3, 4, Masafumi NAKAYAMA1, 5

1Laboratory of Immunology and Microbiology, College of Pharmaceutical Science, Ritsumeikan University, 2Department of Environmental Medicine and Molecular Toxicology, Tohoku University Graduate School of Medicine, 3Department of Pathology and Biological Responses, Nagoya University Graduate School of Medicine, 4CREST, Japan Science and Technology Agency (JST), 5PRESTO, JST

O-5 Inhibitionofnoradrenalinesynthesisbyclioquinol,thecausativeagentofsubacutemyelo-opticneuropathy(SMON)○ Masato KATSUYAMA

Radioisotope Center, Kyoto Prefectural University of Medicine

OralSession2 July 8 (Thu) 11:10 - 12:10Room 4

Chairs: Yasumitsu NISHIMURA (Department of Hygiene, Kawasaki Medical School)Yasuhiro SHINKAI (Environmental Biology Lab, Faculty of Medicine, University of Tsukuba)

MetalsO-6 CadmiumrenaltoxicitythroughthesuppressionofSLC2A4 gene

expression○ Jin-Yong LEE, Maki TOKUMOTO, Masahiko SATOH

School of Pharmacy, Aichi Gakuin University

Program

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O-7 CadmiuminducedERstress/autophagyresponseandsalubrinalreducedthecelldeatheffectinhumanneuroblastomaSH-SY5Ycells○ Takamitsu MIYAYAMA, Masato MATSUOKA

Tokyo Women's Medical University

O-8 Pregnantratsexposedtolowlevelmethylmercuryexhibitcerebellarsynapticandneuriticremodelingduringtheperinatalperiod○ Masatake FUJIMURA1, Fusako USUKI2

1National Institute for Minamata Disease, 2Joint Research Center for Human Retrovirus Infection

O-9 BindingpropertiesofhumanC8gammaagainstorgano-metalcompounds○ Katsuya YAMAMOTO1, Daisuke MATSUMARU1, Youhei HIROMORI1, 2, Keishi ISHIDA1, Satoshi ENDO3, Hisamitsu NAGASE1, 4, Tsuyoshi NAKANISHI1

1Laboratory of Hygienic Chemistry and Molecular Toxicology, Gifu Pharmaceutical University, 2Faculty of Pharmaceutical Sciences, Suzuka University of Medical Science, 3Laboratory of Biochemistry, Gifu Pharmaceutical University, 4School of Pharmacy, Gifu University of Medical Science

O-10 AmeliorativeEffectofCurcuminonArsenicInducedCytotoxicityinPC12 cells ○ Md. Shiblur RAHAMAN1, 2, Masaaki KURASAKI2, 3

1Department of Environmental and Preventive Medicine, Jichi Medical University School of Medicine, 2Graduate School of Environmental Science, Hokkaido University, 3Faculty of Environmental Earth Science, Hokkaido University

OralSession3 July 9 (Fri) 13:30 - 15:06Room 3

Chairs: Kumiko OGAWA (National Institute of Health Sciences)Misaki NAOTA (Pharmaceuticals and Medical devices Agency)

EnvironmentalpollutantsO-11 Preventionoftoxicityinthenextgenerationcausedbymaternal

exposureto2,3,7,8-tetrachlorodibenzo-p-dioxin:recoveryeffectofα-lipoicacidonsexualimmaturity○ Ming YUAN1, Hiroe SANO1, Kyoko NISHIDA1, Takayuki KOGA2, Tomoki TAKEDA1, 3, Yoshitake TANAKA1, Yuji ISHII1

1Graduate School of Pharmaceutical Sciences, Kyushu University, 2Daiichi University of Pharmacy, 3Japan Bioassay Research Center

O-12 ArseniteexposureinducescellularsenescenceandincreasedSASPfactorsinhepaticstellatecellsLX-2,andSASPfactorsremainhighlyexpressedevenafterstoppingtheexposure○ Kazuyuki OKAMURA, Takehiro SUZUKI, Keiko NOHARA

National Institute for Environmental Studies, Center for Health and Environmental Risk Reseach

Program

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O-13 Roleofmacrophagesincytotoxicity,reactiveoxygenspeciesproductionandDNAdamagein1,2-dichloropropane-exposedhumancholangiocytesinvitro○ Abigail EKUBAN1, Cai ZONG1, Frederick Adams EKUBAN1, Yusuke KIMURA1, Ryoya TAKIZAWA1, 3, Kota MORIKAWA1, Kazuo KINOSHITA2, Sahoko ICHIHARA3, Seiichiroh OHSAKO4, Gaku ICHIHARA1

1Department of Occupational and Environmental Health, Tokyo University of Science, Noda, Japan, 2Evolutionary Medicine, Shiga Medical Center Research Institute, Moriyama, Japan, 3Department of Environmental and Preventive Medicine, Jichi Medical University School of Medicine, Shimotsuke, Japan, 4Laboratory of Environmental Health Sciences, Faculty of Medicine, University of Tokyo, Tokyo, Japan

O-14 SulforaphaneAttenuatesAcrylamide-inducedNeuropathyinMiceChand Basha DAVULJIGARI, ○ Frederick Adams EKUBAN, Cai ZONG, Alzahraa A.M. FERGANY, Kota MORIKAWA, Gaku ICHIHARA

Department of Occupational and Environmental Health, Faculty of Pharmaceutical Sciences, Tokyo University of Science

O-15 Micrometer-sizednylon6particlesinducechangesinmetabolomicprofilesoffreshwateralgaRaphidocelissubcapitata○ Satomi MIZUKAMI MURATA1, Yuji SUZUKI1, 2, Kensuke SAKURAI1, Hiromasa YAMASHITA1

1Public Works Research Institute, 2Present Address: Gifu University

NanomaterialsO-16 Analysisofantigen-presentingcellactivationabilityofsilver

nanoparticles○ Asuka NISHIDA1, Takao ASHIKAGA2, Akiko OHNO2, Kazutoshi IIJIMA3

1Graduate School of Engineering Science, Yokohama National University, 2Division of Risk Assessment, Center for Biological Safety and Research, National Institute of Health Sciences, 3Faculty of Engineering, Yokohama National University

EnvironmentalpollutantsO-17 AssessmentoforganicmicropollutantsinpassivesamplesfromJoint

DanubeSurvey4(JDS4)byabatteryofin vitro bioassays○ Pavel SAUER1, Beate I. ESCHER2, Branislav VRANA3, Zuzana TOUSOVA3, Maria KOENIG2, Lili NIU2, Martin KRAUSS2, Petra MIKUSOVA3, Roman PROKES3, Jaromir SOBOTKA3, Pavla FIALOVA3, Rita SCHLICHTING2, Jiri NOVAK3, Roman GRABIC1, Klara HILSCHEROVA3

1University of South Bohemia in Ceske Budejovice, Faculty of Fisheries and Protection of Waters, Research Institute of Fish Culture and Hydrocenoses, the Czech Republic, 2UFZ, Helmholtz Centre for Environmental Research, Cell Toxicology, Germany, 3Masaryk University, Faculty of Science, RECETOX, the Czech Republic

NanomaterialsO-18 ComputationalandbiologicalanalysesofTim4-carbonnanotubes

interactions○ Qilin XIE1, Satoshi OMORI2, Kota KASAHARA3, Shinichiro YAMAGUCHI1, Takuya TAKAHASHI3, Kengo KINOSHITA2, Masafumi NAKAYAMA1, 4

1College of Pharmaceutical Sciences, Ritsumeican University, 2Graduate School of Information Sciences, Tohoku University, 3College of Life Sciences, Ritsumeican University, 4PRESTO, JST

Program

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OralSession4 July 9 (Fri) 15:10 - 16:34Room 3

Chairs: Kazunori FUJIMOTO (Daiichi Sankyo Co., Ltd.)Yasuo YOSHIOKA (Institute for Open and Transdisciplinary Research Initiatives, Osaka University)

GeneraltoxicologyO-19 Chronotoxicityof6-mercaptoprineinmice

○ Masayuki MIYAZAWA1, Fuka TERUI1, Shinichi KATSURAGAWA1, Toshiko KAGAWA-TANAKA1, Ikuo KAWAMURA1, Satoshi YOKOTA2, Hiroki YOSHIOKA3, Masahiro KANEKO1, Nobuhiko MIURA1

1Yokohama University of Pharmacy, 2National Institute of Occupational Safety and Health Japan, 3The University of Texas Health Science at Houston

BehavioraltoxicologyO-20 Developmentofautomatedcognitivebehavioraltoxicologicalassayfor

juvenile mice○ Toshihiro ENDO1, 3, Fumihiko MAEKAWA2, Chiharu TOHYAMA3

1Phenovance Research & Technology, LLC, 2Center for Health and Environmental Risk Research National Institute for Environmental Studies, 3Faculty of Medicine, University of Tsukuba

ImmunotoxicologyO-21 Asbestosexposure-causedalteredgeneexpressionincytotoxicT

lymphocytecelllineanddifferenceinthosebetweenchrysotileandcrocidoliteexposureexploredbytranscriptomeanalysis○ Yasumitsu NISHIMURA, Naoko KUMAGAI-TAKEI, Suni LEE, Tatsuo ITO, Takemi OTSUKI

Department of Hygiene, Kawasaki Medical School

EpigeneticsO-22 Mammalianprimordialgermcellsareimportanttargetforepigenetic

transgenerationalinheritance(ETI)○ Tohru SHIBUYA, Yukiharu HORIYA

“Tox 21” Laboratory

O-23 (Epi)GeneticEffectsofδ-AminolevulinicAcidDehydratase(ALAD)inChildrenExposedtoEnvironmentalLead-aprimarystudyfromKabwe,Zambia○ Yared B. YOHANNES1, 2, Shouta NAKAYAMA1, John YABE3, Hokuto NAKATA1, Haruya TOYOMAKI1, Andrew KATABA1, 3, Kaampwe MUZANDU3, Yoshinori IKENAKA1, Kennedy CHOONGO3, Mayumi ISHIZUKA1

1Laboratory of Toxicology, Department of Environmental Veterinary Sciences, Faculty of Veterinary Medicine, Hokkaido University, 2Department of Chemistry, University of Gondar, Gondar, Ethiopia, 3School of Veterinary Medicine, University of Zambia, Lusaka, Zambia

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Toxicity-testingmethodsO-24 Developmentofanin vitro peripheralneuronculturedeviceand

examinationoftoxicityassessmentXiaobo HAN1, Makoto YAMANAKA2, Nami NAGAFUKU1, Naoki MATSUDA1, ○ Ikuro SUZUKI1

1Department of Electronics, Tohoku Institute of Technology, 2Ushio Inc.

Alternatives to mammalian modelsO-25 High-throughputalternativemethodtodevelopmentaltoxicitytest

basedontheaccumulationofRTK-SRFsignaldisruptionSeiya KANNO1, ○ Yusuke OKUBO2, Satoshi KITAJIMA2, Junji FUKUDA1

1Faculty of Engineering, Yokohama National University, 2Division of Cellular and Molecular Toxicology, Biological Safety and Research Center, National Institute of Health Sciences

OralSession5 July 9 (Fri) 13:30 - 15:18Room 7

Chairs: Izuru MIYAWAKI (Preclinical Research Unit, Research Division, Sumitomo Dainippon Pharma Co., Ltd)Kouichi YOSHINARI (Laboratory of Molecular Toxicology, School of Pharmaceutical Sciences, University of Shizuoka)

NervoussystemO-26 Developmentofthewhole-scaleneuralcircuitactivityevaluation

methodwithvoltage-sensitivedye(VSD):theacuteapplicationofbisphenol-A-relatedsubstancesonhippocampalslices○ Takashi TOMINAGA1, 2, Makiko TAKETOSHI1, 2, Kentaro TANEMURA3, Yoko TOMINAGA1, 2

1Institute of Neuroscience, Tokushima Bunri University, 2Kagawa School Pharmaceutical Sciences, Tokushima Bunri University, 3Laboratory of Animal Reproduction and Development, Graduate School of Agricultural Science, Tohoku University

O-27 Characterizationofneuronaldifferentiationtracermousefornoveldevelopmentalneurotoxicityevaluationsystem○ Keishi ISHIDA, Yoshiki MINAMIGAWA, Kazuma MORI, Daisuke MATSUMARU, Tsuyoshi NAKANISHI

Laboratory of Hygienic Chemistry and Molecular Toxicology, Gifu Pharmaceutical University

O-28 Role of microglia in mediating neurite retraction of noradrenergic neuronsfollowingacrylamideexposureandtranscriptomicanalysis○ Cai ZONG1, Harue SATO1, Sho IWAMA1, Schneider BENOIT2, Makoto URUSHITANI3, Shigeyuki SHICHINO4, Kouji MATSUSHIMA4, Seiichiroh OHSAKO5, Gaku ICHIHARA1

1Faculty of Pharmaceutical Sciences, Tokyo University of Science, 2University of Paris, Inserm UMR-S1124, Paris, France, 3Department of Neurology, Shiga University of Medical Science, 4Research Institute for Biomedical Sciences, Tokyo University of Science, 5Graduate School of Medicine, The University of Tokyo

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CardiovascularsystemO-29 Echocardiographicevaluationofcardiotoxicityinmicetreatedwith

doxorubicin,ananticancerdrug -UtilizationofechocardiographyforCardio-oncology-○ Tomonori KITAURA, Toshiyuki MAKI, Manami KANEKO

Integrated & Translational Science, Axcelead Drug Discovery Partners, Inc.

KidneyO-30 3DNephroscreen:highthroughputdrug-inducednephrotoxicity

screeningonamicrofluidicproximaltubulemodel○ Linda GIJZEN1, M.K. VORMANN1, S. HUTTER1, J. VRIEND2, A. vd HEUVEL1, S. J. TRIETSCH1, J. JOORE1, M. WILMER2, L. SUTER-DICK3, R. MASEREEUW4, P. VULTO1, H. L. LANZ1

1MIMETAS BV, 2Department of Pharmacology and Toxicology, Radboud UMC, PO Box 9101, 6500HB, Nijmegen, The Netherlands, 3University of Applied Sciences Northwestern Switzerland, Muttenz, Switzerland, 4Div. Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht, The Netherlands

LiverO-31 Searchforsignalfactorsinvolvedinhepatocarcinogenesis

associatedwithnon-alcoholicsteatohepatitis(NASH)inmicefedacholine-deficient,methionine-lowered,highfat,aminoacid-defineddiet(CDAA-HF-T(-))○ Noriko KEMURIYAMA, Akari ABE, Megumi YUKI, Kinuko UNO, Sae NAKANE, Atsushi WATANABE, Katsuhiro MIYAJIMA, Dai NAKAE

Department of Nutritional Science and Food Safety, Faculty of Bioscience, Tokyo University of Agriculture

O-32 AutomationandvalidationoftheOrganoPlateLiverToxforhepatotoxicitydetection○ Kristin BIRCSAK1, Richard DEBIASIO2, Mark MIEDEL2, Alaa ALSEBAHI1, Ryan REDDINGER1, Anthony SALEH1, Tongying SHUN2, Lawrence VERNETTI2, Albert GOUGH2

1Mimetas Inc, Gaithersburg, MD, 2University of Pittsburgh Drug Discovery Institute, Pittsburgh, PA

Informationtechnology,AI,andbigdataO-33 Considerationonpointstokeepinmindwhenusingdatascience

andartificialintelligenceintoxicityevaluationresearchdealingwithcompounds(1)○ Kohtaro YUTA

In Silico Data, Ltd.

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AOP(adverseoutcomepathway)O-34 Molecularnetworkanalysisanddevelopmentofadverseoutcome

pathway(AOP)onchronicreactiveoxygenspeciesleadingtohumantreatment-resistant gastric cancer○ Shihori TANABE1, Sabina QUADER2, Ryuichi ONO3, Horacio CABRAL4, Kazuhiko AOYAGI5, Akihiko HIROSE1, Ed PERKINS6, Hiroshi YOKOZAKI7, Hiroki SASAKI8

1Division of Risk Assessment, Center for Biological Safety and Research, National Institute of Health Sciences, 2Innovation Centre of NanoMedicine (iCONM), Kawasaki Institute of Industrial Promotion, 3Division of Cellular and Molecular Toxicology, Center for Biological Safety and Research, National Institute of Health Sciences, 4Department of Bioengineering, Graduate School of Engineering, The University of Tokyo, 5Department of Clinical Genomics, National Cancer Center Research Institute, 6USACE ERDC Environmental Laboratory, 7Department of Pathology, Kobe University of Graduate School of Medicine, 8Department of Translational Oncology, National Cancer Center Research Institute

OralSession6 July 9 (Fri) 15:20 - 16:44Room 7

Chairs: Kiyoshi MATSUMOTO (Takeda Pharmaceutical Company Limited)Makiko KUWAGATA (Division of Cellular and Molecular Toxicology, CBSR, National Institute of Health Sciences)

ReproductivesystemO-35 EffectsofdietaryintakeofhighlevelsofvitaminAonspermatid

morphologyformationinmice○ Satoshi YOKOTA1, 2, Nao SEKINE2, Satoshi KITAJIMA1, Shigeru OSHIO2

1Division of Cellular & Molecular Toxicology, Center for Biological Safety & Research, National Institute of Health Sciences, 2Department of Hygiene Chemistry, School of Pharmaceutical Sciences, Ohu University, Koriyama, Fukushima, Japan

ReproductiveanddevelopmentaltoxicologyO-36 Developmentofashort-termin vivo assayforthyroidhormone

disruptingactivityinmaternalratsandtheirfetuses/pupsasprescreeningforpotentialdevelopmentalneurotoxicity:Propylthiouracilandphenobarbitalexamples.I.Findingsinmaternalratsandtheirfetuses○ Hidenori SUTO1, Akira SATO2, Keiko OGATA1, Kenta MINAMI1, Tadashi KOSAKA2, Hitoshi HOJO2, Naofumi TAKAHASHI2, Naruto TOMIYAMA2, Katsumasa IWASHITA1, Hiroaki AOYAMA2, Tomoya YAMADA1

1Sumitomo Chemical Company, Ltd., 2The Institute of Environmental Toxicology

O-37 Developmentofashort-termin vivo assayforthyroidhormonedisruptingactivityinmaternalratsandtheirfetuses/pupsasprescreeningforpotentialdevelopmentalneurotoxicity:Propylthiouracilandphenobarbitalexamples.II.Findingsinmaternalratsandtheirpups○ Akira SATO1, Hidenori SUTO2, Keiko OGATA2, Kenta MINAMI2, Tadashi KOSAKA1, Hitoshi HOJO1, Naofumi TAKAHASHI1, Naruto TOMIYAMA1, Katsumasa IWASHITA2, Hiroaki AOYAMA1, Tomoya YAMADA2

1The Institute of Environmental Toxicology, 2Sumitomo Chemical Company, Ltd.

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O-38 Usefulnessofinvitroembryogenesistoassessteratogeniceffectofnucleic acid analogues○ Hiroyuki OKA1, Minami WATANABE1, Tomomi OIDA2, Masatoshi YOSHIMURA2, Yuki OKAGAWA2, Mei YOSHIDA2, Kyouhei NISHIMURA1, Masayoshi MIYAGAWA3, Shingo TAKAGI1, Yoshinori ANDO4

1Laboratory for Drug Discovery and Development, SHIONOGI & CO., LTD., 2Shionogi Techno Advance Research & Co., Ltd., 3Laboratory for Medicinal Chemistry Research, SHIONOGI & CO., LTD., 4Laboratory for Drug Discovery and Disease Research, SHIONOGI & CO., LTD.

O-39 QualityControlProtocolforZebrafishDevelopmentalToxicologicalScience○ Toshio TANAKA1, 2, Hajime KOJIMA3, Michio FUJIWARA4, Kanako MORI4, Kyoko YAMAMOTO1, 2, Kayoko YAMADA1, 2, Yuka MIZUTANI1, 2, Aoi MORI1, 2, Yukiko KATO1, 2

1Department of Systems Pharmacology, Mie University Graduate School of Medicine, 2Medical Zebrafish Research Center, Mie University, 3Division of Risk Assessment, National Institute of Health Sciences, 4Drug Safety Research Laboratories, Astellas Pharma Inc.

O-40 Geneticanalysisofthoracolumbarsupernumeraryribsfocusingonphylogeneticdifferences○ Takayuki KUMAMOTO1, Kazuki HASHIMOTO1, Tetsuo OGAWA2, Makiko KUWAGATA3

1School of Pharmaceutical Sciences, Ohu University, 2Faculty of Medical health Sciences, Tokyo International University, 3Division of Cellular and Molecular Toxicology, Center for Biological Safety and Research, National Institute of Health Science

O-41 Effectsofabnormalmicroglialactivityinducedbyprenatalexposureofvalproicacidonthemorphogenesisanddevelopmentofthecerebralcortex○ Munekazu KOMADA, Takuma MATSUI, Tetsuji NAGAO

Department of Life Science, Faculty of Science and Engineering, Kindai University

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e-Poster (PosterSession) -

Pharmaceutical drugs (chemicals)P-1E Evaluationofdifferencesofstructurallysimilarcompoundswith

decompositionanalysisofchemicalprofiledata○ Tadahaya MIZUNO, Katsuhisa MORITA, Shumpei NEMOTO, Hiroyuki KUSUHARA

Molecular Pharmacokinetics, Pharmaceutical Sciences, The University of Tokyo

Agricultural chemicalsP-2E Neurotoxicityofapyrethroidpesticidedeltamethrinmediatedby

imbalanceofproteolyticsystems○ Tetsushi HIRANO1, Nihei SUZUKI1, Yoshinori IKENAKA2, Nobuhiko HOSHI3, Yoshiaki TABUCHI1

1Life Science Research Center, University of Toyama, 2Translational Research Unit, Veterinary Teaching Hospital, Faculty of Veterinary Medicine, Hokkaido University, 3Laboratory of Animal Molecular Morphology, Department of Animal Science, Graduate School of Agricultural Science, Kobe University

MetalsP-3S Methylmercuryinducesvulnerabilityagainstoxidativestressesvia

disruptionofselenium-metabolism○ Runa KUDO, Takashi TOYAMA, Yoshiro SAITO

Division of Molecular-biology and Metabolism, Department of Pharmaceutical Sciences, Tohoku University

P-4S Effectofretinoicacidpathwayonthecadmiumrenaltoxicity○ Chikage MORI, Jinyong LEE, Maki TOKUMOTO, Masahiko SATOH

Laboratory of Pharmaceutical Health Sciences, School of Phrmacy, Aichi Gakuin University

P-5 AmechanismofmethylmercurytoxicitymediatedbyRPSA,anovelTNFR3-bindingproteinYohei TSUNODA2, Takashi TOYAMA2, Sawako SHINDO1, Kento SUGAWARA1, Akira NAGANUMA2, ○ Gi-Wook HWANG1, 2

1Laboratory of Environmental and Health Sciences, Faculty of Pharmaceutical Sciences, Tohoku Medical and Pharmaceutical University, 2Laboratory of Molecular and Biochemical Toxicology, Graduate School of Pharmaceutical Sciences, Tohoku University

P-6 Intracellulardynamicsofuraniumdistributioninculturedrenaltubularcells○ Shino HOMMA TAKEDA1, Hitomi FUJISHIRO2, Izumi TANAKA1, Haruko YAKUMARU1, Kyoko AYAMA1, Akihiro UEHARA1, Masakazu OIKAWA1, Oki SEKIZAWA3, Kiyofumi NITTA3, Seiichiro HIMENO2, 4, Hiroshi ISHIHARA1

1National Institute of Radiological Sciences, National Institutes for Quantum and Radiological Science and Technology, 2Faculty of Pharmaceutical Sciences, Tokushima Bunri University, 3Japan Synchrotron Radiation Research Institute, 4School of Pharmacy, Showa University

P-7 ModulationofcadmiumcytotoxicitybyCHSY1invascularendothelialcells○ Takato HARA1, Shuta ONIZAWA1, Toshiyuki KAJI2, Chika YAMAMOTO1

1Faculty of Pharmaceutical Sciences, Toho University, 2Faculty of Pharmaceutical Sciences, Tokyo University of Science

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P-8 Molecularmechanismoftissuefactorexpressionbyarseniteinhumanaorticsmoothmusclecellsandmacrophage-likeTHP-1cells○ Tsuyoshi NAKANO1, Yumi ARAKI1, Tsutomu TAKAHASHI1, Chika YAMAMOTO2, Toshiyuki KAJI3, Yasuyuki FUJIWARA1

1Department of Environmental Health, School of Pharmacy, Tokyo University of Pharmacy and Life Sciences, 2Department of Environmental Health, Faculty of Pharmaceutical Sciences, Toho University, 3Department of Environmental Health, Faculty of Pharmaceutical Sciences, Tokyo University of Science

P-9 MethylmercuryinducesoncostatinMexpressionviaJak1/STAT3andASK1/JNK/cJunpathwaysinmousemicroglialBV2cellsKantaro CHIBA1, ○ Sawako SHINDO1, Takayuki HOSHI2, Ryu KOMATSU1, Akira NAGANUMA1, Gi-Wook HWANG1

1Environmental and Health Sciences, Faculty of Pharmaceutical Sciences, Tohoku Medical and Pharmaceutical University, 2Laboratory of Molecular and Biochemical Toxicology, Graduate School of Pharmaceutical Sciences, Tohoku University

P-10 X-rayabsorptionspectroscopyonuraniumligandexchangeinserumbetweenbiologicalligandsandchelatingagents○ Akihiro UEHARA1, 2, Daiju MATSUMURA3, Takuya TSUJI3, Haruko YAKUMARU1, Izumi TANAKA1, Ayumi SHIRO4, Hiroyuki SAITOH4, Hiroshi ISHIHARA1, Shino TAKEDA1, 2

1National Institute of Radiological Sciences, National Institutes for Quantum and Radiological Science and Technology, 2Institute for Quantum Life Science (iQLS), National Institute for Quantum and Radiological Science and Technology, Japan, 3Materials Sciences Research Center, Japan Atomic Energy Agency, 4Quantum Beam Science Research Directorate, National Institutes for Quantum and Radiological Science and Technology

P-11S Hypersecretionofbraincytokinesinculturednormalhumancerebellarastrocytesexposedtodiphenylarsinicacid○ Shoto SASAKI1, Takamasa TSUZUKI2, Kazunori YUKAWA2, Takayuki NEGISHI2

1Department of Physiology, Graduate School of Pharmacy, Meijo University, 2Department of Physiology, Faculty of Pharmacy, Meijo University

P-12 Developmentofsensorsformethylmercurytoxicity○ Akio SUMIOKA1, Masatake FUJIMURA1, Fusako USUKI2

1Department of Basic Medical Sciences, National Institute for Minamata Disease, 2Division of Neuroimmunology, Joint Research Center for Human Retrovirus Infection, Kagoshima University

P-13 AdverseeffectsofmethylmercuryongutbacteriaandProtectiveroleofgutmicrobiotaagainstmethylmercuryexposure○ Masahiro AKIYAMA1, Natsumi SEKI1, Yoshito KUMAGAI2, Yun-Gi KIM1

1Research Center for Drug Discovery, Faculty of Pharmacy, Keio University, 2Environmental Biology Laboratory, Faculty of Medicine, University of Tsukuba

P-14S Arseniteenhancestheanti-tumoractivityofphotodynamictherapyusingtalaporfinsodiumagainstU251glioblastomacellline○ Yuuri SHIMIZU1, Yuka YANO1, Kazuna FUJII1, Tsutomu TAKAHASHI1, Yayoi TSUNEOKA1, Yo SHINODA1, Jiro AKIMOTO2, Yasuyuki FUJIWARA1

1Department of Environmental Health, School of Pharmacy, Tokyo University of Pharmacy and Life Sciences, 2Department of Neurosurgery, Tokyo Medical University

P-15S EffectofcadmiumonhumantrophoblastdifferentiationandBeWocellsyncytiation○ Shoko OGUSHI1, Megumi TOYAMA1, Saya NOBUOKA1, Tsuyoshi NAKANISHI2, Tomoki KIMURA1

1Department of Life Science, Faculty of Science and Engineering, Setsunan University, 2Laboratory of Hygienic Chemistry and Molecular Toxicology, Gifu Pharmaceutical University

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IndustrialchemicalsP-16 Short-termevaluationusingγ-H2AXimmunostainingformucosal

toxicityandcarcinogenicityofaromaticaminesintheraturinarybladder○ Takeshi TOYODA1, Takanori YAMADA1, 2, Kohei MATSUSHITA1, Hirotoshi AKANE1, Tomomi MORIKAWA1, Kumiko OGAWA1

1Division of Pathology, National Institute of Health Sciences, 2Laboratory of Veterinary Pathology, Tokyo University of Agriculture and Technology

Foods,foodadditives,andfoodcontaminantsP-17S TheInfluenceofFumonisinB3oninflammatoryresponseand

cutaneousbarrierfunctioninamousemodelofatopicdermatitis○ Mana ANDO1, Ai MORIMOTO1, Hiroki YAMAGUCHI1, Naoki IWASHITA2, Yoshiichi TAKAGI3, Tomoya YOSHINARI4, Tomoki FUKUYAMA1

1Laboratory of Veterinary Pharmacology, School of Veterinary Medicine, Azabu University, 2Bioalchemis, 3Japan SLC,Inc., 4National Institute of Health Sciences

P-18 InvestigationofmembranepermeabilityandmetabolismofcompoundsinfoodusinghumaniPScell-derivedsmallintestinalepithelialcells○ Takashi KITAGUCHI1, Taisei MIZOTA1, Mina ITO1, Katsutoshi OHNO1, Kazuhiro KOBAYASHI1, Isamu OGAWA2, Shimeng QIU2, Takahiro IWAO2, Nobumitsu HANIOKA3, Mitsuru TANAKA1, Tamihide MATSUNAGA2

1Global Food Safety Institute, Nissin Foods Holdings Co., Ltd., 2Department of Clinical Pharmacy, Graduate School of Pharmaceutical Sciences, Nagoya City University, 3Department of Health Pharmacy, Yokohama University of Pharmacy

P-19 Investigationofthemechanismsunderlyinghepatocarcinogenesisof1,3-dichloro-2-propanolusinggpt delta transgenic rats○ Shinji TAKASU, Yuji ISHII, Kenji NAKAMURA, Moeka NAMIKI, Takehiko NOHMI, Kumiko OGAWA

Division of Pathology, National Institute of Health Sciences

EnvironmentalpollutantsP-20 EffectofcombinedexposuretoenvironmentalelectrophilesonNrf2

activationandcytotoxicityinHepG2cells○ Hanako AOKI1, Yumi ABIKO1, 2, Yoshito KUMAGAI1, 2

1Graduate School of Comprehensive Human Sciences, University of Tsukuba, 2Faculty of Medicine, University of Tsukuba

P-21 CaptureofAirborneQuinonesintheExtracellularspace:APieceofEvidence for Phase-Zero Reaction○ Reiko HIROSE1, Yasuhiro SHINKAI1, 2, Yusuke ONOSE2, Masahiro AKIYAMA3, Yoshito KUMAGAI1, 2

1Environmental Biology Laboratory, Faculty of Medicine, University of Tsukuba, 2Master's Program in Medical Sciences, Graduate School of Comprehensive Human Sciences, University of Tsukuba, 3Research Center for Drug Discovery Faculty of Pharmacy, Keio University

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P-22S SuppressionofPI3K–Aktsignalingmediatedbymethylvinylketonethroughproteinmodification○ Atsushi MORIMOTO1, Naoshi DOMAE2, Takashi UEHARA1

1Department of Medicinal Pharmacology, Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama University, 2Biomolecular Characterization Unit, Center for Sustainable Resource Science, Institute of Physical and Chemical Research

P-23 ExpressionprofilingofPLA2genesintheliverof2,3,7,8-tetrachlorodibenzo-p-dioxin-exposedmice○ Wataru YOSHIOKA

School of Veterinary Medicine, Azabu University

P-24 RSS-producingenzymeCSEsuppressesmethylmercury-inducedbrainmercuryaccumulationanddeleteriouseffectsinmice○ Takamitsu UNOKI1, Masahiro AKIYAMA2, Yasuhiro SHINKAI4, Isao ISHII3, Yoshito KUMAGAI4

1Department of Basic Medical Sciences, National Institute for Minamata Disease, 2Faculty of Pharmacy, Keio University, 3Showa Pharmaceutical University, 4Faculty of Medicine, University of Tsukuba

P-25 EffectsofPolycyclicAromaticHydrocarbonsPollutantsonthePigmentIntensityofZebrafishEmbryosinSedimentsofBohaiBay○ Xiaoyu YIN1, Wenjing DONG1, 2, Jingli MU3, Jingfeng YANG1, Hiroki TERAOKA2, Wu DONG1

1Collage of Animal Science and Technology, Inner Mongolia University for Nationalities, 2School of Veterinary Medicine, Rakuno Gakuen University, 3Institute of Oceanography, Minjiang University

P-26 EnhancedTCDDtoxicityonzebrafishembryoscausedbyaraisedtemperature○ Hao CHEN, Hongsong CHEN, Xiaoyu YIN, Chi FENG, Chelimuge QI, Lei SONG, Wenjing DONG, Bao CHAO, Jingfeng YANG, Wu DONG

Collage of Animal Science and Technology, Inner Mongolia University for Nationalities

P-27 Effectofformaldehydeonlunginjuryinanimalmodelofpulmonaryarterialhypertension○ Chul Min PARK1, Young-Jun SHIN1, Injeong KIM1, Gyuhwan BAE1, Gijun OH1, Mi-Jin YANG2, Min-Seok KIM1

1Inhalation Toxicity Research Group / Korea Institute of Toxicology, 2Pathology Research Group / Korea Institute of Toxicology

EndocrinedisruptorsP-28 Evaluationofendocrineactivitiesofbisphenolsusingprogesterone

reportergeneassaysJunya KITAMOTO1, ○ Masahiro OGAWA1, 2, Sayoko ITO-HARASHIMA2, Masanobu KAWANISHI2, Masami HORI1, Takashi YAGI2, Megumi TERADA1

1Life Science Research Institute, Kumiai Chemical Industry Co. Ltd, 2Department of Biological Science, Graduate School of Science, Osaka Prefecture University

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NanomaterialsP-29 Effectsofnanoparticleonneonatallymphoidpopulationdependingon

thestageofexposureduringgestation○ Atsuto ONODA1, 2, 3, Saki OKAMOTO2, Ryuhei SHIMIZU2, El-Sayed S. YASSER 4, Shiho WATANABE5, Shuhei OGAWA1, 5, Ryo ABE5, 6, Ken TACHIBANA1, 2, 3, Ken TAKEDA1, 2, 3, Masakazu UMEZAWA1, 2, 7

1The Center for Environmental Health Science for the Next Generation, Research Institute for Science and Technology, Tokyo University of Science, 2Faculty of Pharmaceutical Sciences, Tokyo University of Science, 3Faculty of Pharmaceutical Sciences, Sanyo-Onoda City University, 4Faculty of Veterinary Medicine, Damanhour University, 5Research Institute for Biomedical Sciences, Tokyo University of Science, 6Strategic Innovation and Research Center, Teikyo University, 7Faculty of Industrial Science and Technology, Tokyo University of Science

P-30 Genetictoxicityofphosphorylatedcellulosenanofibrils○ Katsuhide FUJITA, Sawae OBARA, Junko MARU, Shigehisa ENDOH

National Institute of Advanced Industrial Science and Technology (AIST)

P-31 Comparisonoftwodifferentdevicesfora2-yeartoxicitystudyof multi-walledcarbonnanotubes(MWCNT)inratsbyrepeatedintratrachealinstillations:ainterimreportattheendofyear1○ Ai MAENO1, Motoki HOJO1, Yoshimitsu SAKAMOTO1, Katsuhiro YUZAWA1, Yuko HASEGAWA1, Akemichi NAGASAWA1, Kiyomi IKUSHIMA1, Kyoko HIRAMATSU1, Fujifumi KAIHOKO1, Yukio YAMAMOTO1, Hiroshi ANDO1, Kazuyoshi TANAKA1, Jin SUZUKI1, Akiko INOMATA1, Takako MORIYASU1, Yuhji TAQUAHASHI2, Satoshi YOKOTA2, Norihiro KOBAYASHI2, Akihiko HIROSE2, Dai NAKAE3

1Tokyo Metropolitan Institute of Public Health, 2National Institute of Health Sciences, 3Tokyo University of Agriculture

P-32S PulmonaryeffectsofFe3O4-PEG-PLGAnanoparticlesinwildtypeandNrf2knockoutmicefollowingpharyngealaspiration○ Harue SATO1, Cai ZONG1, Stéphanie DEVINEAU2, Claire MCCORD2, Sahoko ICHIHARA3, Oliver BROOKES2, Frederick Adams EKUBAN1, Ken ITOH4, Masayuki YAMAMOTO5, Sonja BOLAND2, Armelle BAEZA-SQUIBAN2, Gaku ICHIHARA1

1Faculty of Pharmaceutical Sciences, Tokyo University of Science, 2Université de Paris, BFA, UMR 8251, CNRS, F-75013 Paris, France, 3School of Medicine, Jichi Medical University, 4Graduate School of Medicine, Hirosaki University, 5Graduate School of Medicine, Tohoku University

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P-33E Comparativetoxicityandcarcinogenicitypulmonarystudyofdouble-walledcarbonnanotubes(DWCNT)withmulti-walledcarbonnanotubes-7(MWCNTS-7)inaratmodel○ Dina M. SALEH1, 2, 3, Shengyong LUO5, David B. ALEXANDER1, Ahmed M. EL-GAZZAR7, Mohammed ABDELGAIED6, Omnia H. MOHAMMED1, 2, 4, Willim T. ALEXANDER1, Sivagami GUNASEKARAN1, Takamasa NUMANO1, Hiroshi TAKASE8, Makoto OHNISHI9, Satoru TAKAHASHI2, Hiroyuki TSUDA1

1Nanotoxicology Lab Project, Nagoya City University, Nagoya, Japan, 2Departement of Experimental Pathology and Tumor Biology, Graduate School of Medicine, Nagoya City University, Nagoya, Japan, 3Departement of Forensic Medicine and Clinical Toxicology, Faculty of Medicine, Assuit University, Assuit, Egypt, 4Departement of Forensic Medicine and Clinical Toxicology, Faculty of Medicine, Aswan University, Aswan, Egypt, 5Anhui Medical University, College of Basic Medical Sciences, Hefei, China, 6Departement of Forensic Medicine and Toxicology, Faculty of Veterinary Medicine, Beni-suef University, Beni-suef, Egypt, 7Departement of Forensic Medicine and Toxicology, Faculty of Veterinary Medicine, Alexandria University, Alexandria, Egypt, 8Core Laboratory, Graduate School of Medicine, Nagoya City University, Nagoya, Japan, 9Japan Industrial Safety and Health Association, Japan Bioassay Research Center, Hadano, Kanagawa, Japan

NervoussystemP-34 EvaluationofConvulsionPotentialinRatsUsingMotorEvoked

Potentials○ Kazuhiro KUGA1, Harushige OZAKI1, Minoru FUJIKI2

1Takeda Pharmaceutical Company Ltd., 2Oita University

P-35 Developmentofinvitroseizureliabilityassayusingvoltage-sensitivedye(VSD)imaginginmicehippocampalslices○ Yuichi UTSUMI1, 2, Makiko TAKETOSHI2, Nana OHARA3, Michiko MIWA3, Yoko TOMINAGA2, Takashi TOMINAGA1, 2, 3

1Graduate School of Pharmaceutical Sciences, Tokushima Bunri University, 2Institute of Neuroscience, Tokushima Bunri University, 3Kagawa School of Pharmaceutical Sciences, Tokushima Bunri University

P-36E Effectsofparticlematter2.5(PM2.5)exposureontheprognosisofischemic stroke in mice○ Miki TANAKA1, Ami OGURO1, Yu NABETANI2, Tomoaki OKUDA3, Kouichi ITOH4, Yasuhiro ISHIHARA1

1Program of Biomedical Science, Graduate School of Integrated Sciences for Life, Hiroshima University, 2Department of Applied Chemistry, University of Miyazaki, 3Department of Applied Chemistry, Faculty of Science and Technology, Keio University, 4Laboratory for Pharmacotherapy and Experimental Neurology, Kagawa School of Pharmaceutical Sciences, Tokushima Bunri University

P-37E DetectionofbrainfunctiondisruptioncausedbynicotinicacetylcholinereceptoragonistsusingCa2+imagingwithtwo-photonmicroscopy○ Anri HIRAI1, Shouta SUGIO2, Collins NIMAKO1, Shouta M.M. NAKAYAMA1, Keisuke KATO3, Keisuke TAKAHASHI3, Koji ARIZONO4, Tetsushi HIRANO5, Nobuhiko HOSHI6, Kazutoshi FUJIOKA7, Kumiko TAIRA8, Mayumi ISHIZUKA1, Hiroaki WAKE2, Yoshinori IKENAKA1, 9

1Laboratory of Toxicology, School of Veterinary Medicine, Hokkaido University, 2Department of Anatomy and Molecular Cell Biology, Graduate School of Medicine, Nagoya University, 3Faculty of Pharmaceutical Sciences, Toho University, 4Faculty of Environmental and Symbiotic Sciences, Prefectural University of Kumamoto, 5Life Science Research Center, University of Toyama, 6Student Affairs Section, Graduate School of Agricultural Science, Kobe University, 7Albany College of Pharmacy and Health Sciences, 8Department of Anaesthesiology, Medical Center East, Tokyo Women’s Medical University, 9Water Research Group, Unit for Environmental Sciences and Management, North-West University

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P-38S Principalcomponentanalysistoseizurepotentialofdrugsusingelectroencephalograminrats○ Yuto ISHIBASHI1, Kenichi KINOSHITA2, Ai OKAMURA2, Takafumi SHIRAKAWA2, Ikuro SUZUKI1

1Graduate School of Engineering, Tohoku Institute of Technology, 2Drug Safety Research Lab., Astellas Pharma Inc.

P-39E DevelopmentofAIforpredictingseizureliabilityofdrugsinelectroencephalographyusingfrequencyintensitydistributionimages○ Naoki MATSUDA1, Kenichi KINOSHITA2, Ai OKAMURA2, Takafumi SHIRAKAWA2, Ikuro SUZUKI1

1Tohoku Institute of Technology, Graduate School of Engineering., 2Drug Safety Research Lab., Astellas Pharma Inc.

P-40E Approachestoneurotoxicologyassessmentbasedondetailedpropagationpatternsinacutebrainslices○ Shuhei NOJI, Naoki MATSUDA, Ikuro SUZUKI

Department of Electronics, Tohoku Institute of Technology

LiverP-41 ConstructionofHepaticVascularModelandToxicityAssessment

SystemthatCanPredictDILICompounds○ Yasuyuki NAITO1, 4, Yuka YOSHINOUCHI1, 4, Hiroshi KOHARA3, Shiro KITANO1, 4, Shinji IRIE4, Michiya MATSUSAKI2, 4

1Technical Research Institute, TOPPAN PRINTING CO., LTD., 2Department of Applied Chemistry, Graduate School of Engineering, Osaka University, 3Drug Safety Research and Evaluation, Takeda Pharmaceutical Company Limited, 4Joint Research Laboratory (TOPPAN) for Advanced Cell Regulatory Chemistry, Graduate School of Engineering, Osaka University

P-42 Time-Courseevaluationofhepatomegalyinmiceusingmicro-CTandtheaspectinterferingtoxicologicalinterpretation○ Kensuke KAWAMOTO, Kyohei YAMAGUCHI, Yukako SHIMOTSUMA, Kaori MIYATA, Hiroyuki ASANO, Tokuo SUKATA

Environmental Health Science Laboratory, Sumitomo Chemical

P-43 Hepaticglucose-dependentinsulinotropicpolypeptideexpressionismodifiedbyongoingthiaminesupplementationinobesediabeticrats○ Yuka KOHDA1, Nobuyuki FUKUISHI2, Hitoshi MATSUMURA1

1Department of Pharmacotherapeutics, Faculty of Pharmacy, Osaka Medical and Pharmaceutical University, 2Department of Pharmacology, College of Pharmacy, Kinjo Gakuin University

P-44E Studyonthemechanismoffattyliverimprovementbynicotinamideinnon-alcoholicfattyliver(NAFL)modelanimals○ Chie YOKOUCHI1, 3, Yukari NISHIMURA2, Hirohiko GOTO2, Makoto SATO2, Yuya HIDOH1, Kenji TAKEUCHI1, Yuji ISHII3

1Department of Drug Metabolism and Pharmacokinetics, Nonclinical Research Center, Tokushima Research Institute, Otsuka Pharmaceutical Co., Ltd, 2Department of Drug Safety, Nonclinical Research Center, Tokushima Research Institute, Otsuka Pharmaceutical Co., Ltd, 3Division of Pharmaceutical Cell Biology, Graduate School of Pharmaceutical Sciences, Kyushu University

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P-45 Activationofhumanhepaticstellatecellspheroidsforevaluationofliverfibrosis○ Seiichi ISHIDA1, Yukie KURODA2, Shinichiro HORIUCHI2, Satoha AIHOSHI1, Riko JINNO1, Yuji KOMIZU1, Taku MATSUSHITA1

1Department of Applied Life Science, Faculty of Biotechnology and Life Science, Sojo University, 2Division of Pharmacology, National Institute of Health Sciences

P-46S Effectsofarylacetamidedeacetylaseonketoconazole-inducedhepatotoxicityandadrenaldysfunctioninmice○ Mai NAGAOKA1, Tatsuki FUKAMI1, 2, Fumiya KISUI1, Takuya YAMADA1, Yoshiyuki SAKAI1, Kiyomichi TASHIRO1, Takuo OGISO1, Keigo KONISHI1, Shiori HONDA1, Keiya HIROSAWA1, Masataka NAKANO1, 2, Miki NAKAJIMA1, 2

1Drug Metabolism and Toxicology, Faculty of Pharmaceutical Sciences, Kanazawa University, 2WPI Nano Life Sciences Institute (WPI-NanoLSI), Kanazawa University

P-47S EvaluationoftheratCARactivationforthepredictionofchemicallivercarcinogenesis○ Takumi SATO, Ryota SHIZU, Yoshie MIURA, Takuomi HOSAKA, Takamitsu SASAKI, Yuichiro KANNO, Kouichi YOSHINARI

Laboratory of Molecular Toxicology, School of Pharmaceutical Sciences, University of Shizuoka

P-48E Evaluationofdrugmetabolismanddrug-inducedtoxicityusingpolydimethylsiloxane-basedliver-on-a-chip○ Sayaka DEGUCHI1, 2, Masahiro TSUDA3, Kaori KOSUGI1, Hiroyuki MIZUGUCHI2, Fumiyoshi YAMASHITA3, Yu-suke TORISAWA4, Kazuo TAKAYAMA1

1Center for iPS Cell Research and Application, Kyoto University, 2Graduate School of Pharmaceutical Sciences, Osaka University, 3Graduate School of Pharmaceutical Sciences, Kyoto University, 4Graduate School of Engineering, Kyoto University

P-49 Feasiblepediatricnon-alcoholicfattyliverdiseaseratmodelproducedbylow-proteinandlow-potassiumdiet○ Chihiro ENDOH1, Yukie ABIKO1, Hiromi NOZAKI-NAMIKI1, Miho AOTSUKA1, Sakiko FUJII1, Masao HORIMOTO2, Yutaka MATSUI1, Masao MATSUURA1

1Safety Research Institute for Chemical Compounds Co., Ltd., 2Chiba Institute of Science

P-50S InvolvementofSox9inliverfibrosisofnon-alcoholicsteatohepatitis(NASH)dietarilyinducedinmice○ Sae NAKANE1, Noriko KEMURIYAMA2, Akari ABE3, Megumi YUKI3, 5, Kinuko UNO4, Syuji OGAWA4, Ryuhei SANO4, Atushi WATANABE4, Shinji TAKASU6, Takashi UMEMURA6, 7, Katuhiro MIYAJIMA1, 2, 3, 4, Dai NAKAE1, 2, 3, 4

1Department of Nutritional Science and Food Safety, Graduate School of Applied Bioscience, Tokyo University of Agriculture, 2Department of Nutritional Science and Food Safety, Faculty of Bioscience, Tokyo University of Agriculture, 3Department of Nutritional Science and Food Safety, Graduate School of Agriculture, Tokyo University of Agriculture, 4Department of Food and Nutritional Science, Graduate School of Agriculture, Tokyo University of Agriculture, 5Advantec Co.,Ltd. Pathology Department, 6Division of Pathology, National Institute of Health Science, 7Faculty of Animal Health Techolorgy, Yamazaki University of Animal Health Techology

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P-51S AnalysisofERphagyinthepreneoplasticlesionsinnonalcoholicfattyliverdisease-relatedearlyhepatocarcinogenesismodel○ Suzuka UOMOTO, Saori SHIMIZU, Keisuke TAKESUE, Natsuno MAEDA, Mio KOBAYASHI, Kanami OSHIMA, Emika HARA, Wen ZENG, Makoto SHIBUTANI, Toshinori YOSHIDA

Laboratory of Veterinary Pathology, Tokyo University of Agriculture and Technology

P-52S Analysisofinshort-termbaitswitchingtesttocholine-deficient,methionine-lowered,amineacid-defineddiet(CDAA)inducedNASH(NonalcoholicSteatohepatitis)-likepathologyinrats○ Marika TOHMA1, Katsuhiro MIYAJIMA1, 3, Kinuko UNO2, Teppei UECHI3, Noriko KEMURIYAMA3, Dai NAKAE1, 3

1Department of Nutritional Science and Food Safety, Graduate School of Applied Biological Sciences, Tokyo University of Agriculture, 2Department of Department of Food and Nutrition Science, Graduate School of Agriculture, Tokyo University of Agriculture, 3Department of Nutritional Science and Food Safety, Faculty of Applied Biological Sciences, Tokyo University of Agriculture

P-53S Effectofhighfatdietonliverindb/dbandKK-Aymice○ Kouhei MANDAI1, Katsuhiro MIYAJIMA1, 2, 3, Sayaka KITAMURA2, Ayane YAMAGUCHI3, Kinuko UNO4, Fuko KUROKI6, Mei NISHIDA6, Koudai SHIRASAKA6, Takahiro TSUTSUI6, Yamato MURO6, Miki SUGIMOTO6, Noriko KEMURIYAMA2, Masami SHINOHARA5, Tomohiko SASASE6, Takeshi OHTA5, 6, Dai NAKAE1, 2, 4

1Department of Nutritional Science and Food Safety, Faculty of Applied Bioscience, Graduate School of Tokyo University of Agriculture, 2Department of Nutritional Science and Food Safety, Faculty of Applied Bioscience, Tokyo University of Agriculture, 3Department of Nutritional Science and Food Safety, Graduate School of Agriculture, Tokyo University of Agriculture, 4Department of Food and Nutrition Science, Graduate School of Agriculture, Tokyo University, 5Tokyo Animal & Diet Dept. CLEA Japan, Inc., 6Laboratory of Animal Physiology and Functional Anatomy, Graduate School of Agriculture, Kyoto University

P-54S Alterationofbileacidcompositionisapossibleriskfactorofantibiotics-inducedliverinjury○ Yusuke KINOSHITA, Kotaro HAYASAKI, Akinori TAKEMURA, Kousei ITO

Laboratory of Biopharmaceutics, Graduate School of Pharmaceutical Science, Chiba University

P-55 Associationbetweenin vitro nuclearreceptor-activatingprofilesandtheir in vivo rathepatotoxicphenotypesofchemicalcompounds○ Susumu KODAMA1, Nao YOSHII1, Akihiro OTA1, Kouichi YOSHINARI2, Atsushi ONO1

1Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama University, 2School of Pharmaceutical Sciences, University of Shizuoka

P-56S Analysisofthemechanismforcentrilobularhepatocytehypertrophyusingratrepeated-dosetoxicitytestdata○ Naoki SHIBATA, Ryota SHIZU, Takuomi HOSAKA, Yuichiro KANNO, Kouichi YOSHINARI

Laboratory of Molecular Toxicology, School of Pharmaceutical Sciences, University of Shizuoka

KidneyP-57 CD44expressionintransitionfromcisplatin-inducedacutekidney

injurytochronickidneydisease○ Kohei MATSUSHITA, Takeshi TOYODA, Hirotoshi AKANE, Tomomi MORIKAWA, Kumiko OGAWA

Division of Pathology, National Institute of Health Sciences

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P-58 Distributionanalysisviadesorptionelectrosprayionization-massspectrometryimaging(DESI-MSI)ofcomponentsofmaddercolorinthekidneysofrats○ Yuji ISHII, Kenji NAKAMURA, Moeka NAMIKI, Shinji TAKASU, Kumiko OGAWA

Division of Pathology, National Institute of Health Sciences

SensoryorganP-59 Electroretinogram(ERG)evaluationforHCNinhibitorinrats:search

fortheretinalcellsinwhichfunctionalabnormalitybyIvabradinewasnoted with long-duration light stimuli○ Naohisa UMEYA, Hiroshi INADA, Izuru MIYAWAKI

Preclinical Research Unit, Sumitomo Dainippon Pharma Co., Ltd.

P-60 TheuseofratEMGtoquantifyvascularpain○ Maki KOCHIZAWA, Naoko KATSU, Akihito ITO, Ayahito KIMURA

Shiga Laboratory, NISSEI BILIS Co., Ltd.

RespiratorysystemP-61 Developmentofaninvitrorespiratorysensitizationtestbyreproducing

respiratory-specificimmuneresponses○ Ikuya TANABE1, Shinkichi ISHIKAWA1, Kanae ISHIMORI1, Tsuneo HASHIZUME1, Takayuki YOSHIMOTO2, Takao ASHIKAGA3

1Scientific Product Assessment Center, R&D Group, Japan Tobacco Inc., 2Department of Immunoregulation, Institute of Medical Science, Tokyo Medical University, 3Division of Risk Assessment, National Institute of Health Sciences

P-62 Utilityofcomputedtomography(CT)inbleomycin-inducedlungfibrosismicemodel:Non-invasivequantitativeevaluationoflunginjury,2ndreport○ Masao OGUCHI, Yasuhiro DANBARA, Daisuke IDO, Jun WATANABE, Rie AMEMIYA, Hiromasa SATO, Ryota SEKI, Atsushi FUJIWARA, Shin-ichi SATO

Ina Research Inc.

P-63 Evaluationofbloodgasesusingbloodsamplesfromratsunderanesthesia○ Yasue SAKAGUCHI, Tetsuo TONOUCHI, Michiyo NAKAJIMA, Miki SHIMOSAWA, Kiyoshi MORIMOTO, Shin-ichi SATO

Ina Research Inc.

P-64S Comparativeinvestigationofrespiratorytoxicityinducedbyozoneexposurebetweenuntreatedmouseandmousemodelofacuterespiratorydistresssyndrome○ Toa OKAWARA1, Ryota AIHARA1, Ai MORIMOTO1, Kengo TOMITA2, Takashi KURIHARA2, Tomoki FUKUYAMA1

1Laboratory of Veterinary Pharmacology, School of Veterinary Medicine, Azabu University, 2Medical Environment Engineering Group, Center for Environmental Engineering, Institute of Technology, Shimizu Corporation

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P-65 SARS-CoV-2infectionofAlveolarEpithelialCellsDifferentiatedfromHumanInducedPluripotentStemCells○ Shigeru YAMADA1, 2, Kayoko TSUJI1, Yasunari KANDA1

1NIHS, 2PEIJ

P-66 Evaluationoflungdamagebyrepeatedintratrachealinstillationofwhole cigarette smoke extract○ Young-Jun SHIN1, Injeong KIM1, Chul Min PARK1, Gyuhwan BAE1, Ryeo-Eun GO2, Kyung-Chul CHOI2, Min-Seok KIM1

1Inhalation Toxicity Research Group, Korea Institute of Toxicology, 2Laboratory of Biochemistry and Immunology, College of Veterinary Medicine, Chungbuk National University

CardiovascularsystemP-67 InvestigationofTdPriskevaluationbyhERG,Na,andCacurrent

measurement○ Kimihito YOSHIKAWA, Minami ARAYAMA, Yoshio MATSUMOTO, Mayumi OBO, Masakazu IMAIZUMI, Munehiro NAKAGAWA

LSIM Safety Institute

P-68 DevelopmentofCardiotoxicityAssessmentMethodforCombinedAdministrationofTrastuzumab(TRZ)andDoxorubicin(DOX)inMice -MyocardialStrain(GLS)bySpeckle-trackingEchocardiography-○ Fumiyuki NAKANE, Maki TAKAHASHI, Hiroyuki SAITO, Takayuki KUBOTA, Miyuki TAKAO, Hiroki KOSAKA, Yasuaki OISHI, Kumiko KITTA, Atsuko ICHIKAWA, Akihiro KANNO, Yasuki AKIE

CMIC Pharma Science Co.,Ltd.

ReproductivesystemP-69E Risk assessment of AAV transmission to the next generation

-in-situ hybridizationusinggonadaltissuesofmonkeysadministeredin-house AAV-○ Naoko OTANI, Yudai WATANABE, Kou OMURA

Astellas Pharma Inc

EndocrinesystemP-70 Historicalcontroldataforserumthyroidhormone(T3,T4)andthyroid-

stimulatinghormone(TSH)levels○ Miho AOTSUKA, Chihiro ENDOH, Miki KAWAKAMI, Fumiko ISHIKAWA, Kaoru YABE, Sakiko FUJII, Yutaka MATSUI, Masao MATSUURA

Safety Research Institute for Chemical Co.,Ltd.

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OtherorgansorsystemP-71 MetallothioneinexpressioninAmlodipine-treatedthegingivalcells

○ Yukihiko TAMURA1, Pornpoj FUANGTHARNTHIP2, Shinichi ONO4, Yoshihiro WAKI3

1Department of Pharmacology, Division of Bio-Matrix, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, 2Department of Advanced General Dentistry, Mahidol University, Faculty of Dentistry, Bangkok, Thailand, 3The Center for Promotion of Pharmaceutical Education, Nihon Pharmaceutical University, 4Laboratory of Clinical Medicine, School of Pharmacy, Nihon University

P-72E Detailedinvestigationofbonemarrowtoxicityinducedbyanticancerdrugs in various animals○ Yoko NISHINO1, Yuko NAGAYAMA1, Yukiko MIYAJIMA2, Yosuke NAKATANI2, Haruka NISHIYA3, Naomi WAKAYAMA2, Etsuko OHTA1, Shoji ASAKURA1

1Global Drug Safety, Eisai Co., Ltd., 2Global Drug Metabolism and Pharmacokinetics, Eisai Co., Ltd., 3Tsukuba R&D Supporting Division, Sunplanet Co., Ltd.

GeneraltoxicologyP-73 ComparisonofJSCCmethodandIFCCmethodonmeasurementof

serumandplasmaalkalinephosphatase(ALP)measurementinrats○ Takashi TATEOKA, Tomohiro KOIKE, Yoshimi INOUE, Taizo TOMARI, Naoki INAMURA, Naoya MASUTOMI

Safety Research Laboratories, Sohyaku. Innovative Research Division, Mitsubishi Tanabe Pharma Corporation

P-74 CasesofsuspectedNSAIDsintoleranceofmicrominipigscausedbyacetaminophenadministration○ Akihiro ISHIMOTO, Masashi YAMAMOTO, Kagari KIMURA, Hironobu IKEDA, Toshiyuki FUJII, Takeshi IIDAKA

Nissei Bilis Co., Ltd. Shiga Laboratory

P-75 Effectsofinhalationalanestheticsonhematologyandbloodbiochemistryinmice○ Katsuhiko HORI, Hitomi MATSUDA, Shoko KOSUGI, Ayahito KIMURA

NISSEI BILIS Co., Ltd., Shiga Laboratory

P-76 Influencesofrearingequipmentontoxicitytestinrats○ Maki KOCHIZAWA, Hitomi MATSUDA, Akihiro ISHIMOTO, Kaori MUSUMI, Isamu OKAZAKI, Ayahito KIMURA

Shiga Laboratory, NISSEI BILIS Co., Ltd.

P-77 WithdrawalP-78 SupportingEfficienciesinNonclinicalToxicologyStudiesThrough

CommonTemplates○ Tamio FUKUSHIMA3, Joseph HORVATH4, Peter R BRINCK1, Sophia G MOESGAARD1, Mark CARFAGNA2, Sarah H LOPES5, Nichole VANSELL5, Jennifer R INGRAM6, Lynch PHILLIP4, Emde BARBARA7

1Novo Nordisk, 2Eli Lilly, 3Shionogi & Co., Ltd., 4Bristol Myers Squibb, 5Pfizer, 6Janssen Research & Development, 7Boehringer-Ingelheim Pharma GmbH & Co.KG

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P-79 UtilizingCDISCSENDDatatoGenerateHistoricalControlIncidencefromaLargeDatabaseofToxicologyStudies○ Tamio FUKUSHIMA4, Joseph HORVATH1, Mark CARFAGNA2, Christopher ELEY3, William HOUSER1, Cheryl SLOAN1, Todd PAGE2, Jesse ANDERSON5, Kevin SNYDER5, Rick THOMPSON6, Bo LARSEN7, Gitte ULLMANN7, Yousuf ALI5, 8

1Bristol Myers Squibb, 2Eli Lilly, 3Pfizer, Inc, 4Shionogi & Co., Ltd., 5CDER, US FDA, 6Janssen, 7Novo Nordisk, 8Oak Ridge Institute for Science and Education

P-80 Collectionofbasicdataforintroductionofmicrochipsforindividualidentificationinmousetoxicitystudies○ Kensuke MIZUYOSHI, Yuki MINAYOSHI, Minori YOSHIMURA, Rie YASUDA, Junko FUJISHIMA, Hideshi TSUSAKI

Shin Nippon Biomedical Laboratories, Ltd (SNBL) Drug Safety Research Laboratories

P-81 TheincidenceofsuddendeathsinthecontrolgroupintoxicitystudiesinSDrats○ Koji MITA, Takezo OKAMOTO, Go MARUYAMA, Kensuke SHIBAKITA, Kensuke SATOMOTO, Keisuke SHIMAMOTO, Yuichi KUROIWA

BoZo Research Center Inc.

P-82 SummaryofdeathsinthecontrolgroupintoxicitystudiesinICRmice○ Takezo OKAMOTO, Koji MITA, Go MARUYAMA, Kensuke SHIBAKITA, Kensuke SATOMOTO, Keisuke SHIMAMOTO, Yuichi KUROIWA

BoZo Research Center Inc.

P-83 ComparisonoftoxiceffectofNasalicylatebyoralandintravenousadministrationincynomolgusmonkeys○ JungHwan LEE, YunShik OH, Choong-Yong KIM

Toxicology Research Center / Genia Inc.

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ReproductiveanddevelopmentaltoxicologyP-84 CombinedeffectsofmaternalexposuretofungicidesinF1-generation

mice:Fixed-dosestudyofimazalil○ Toyohito TANAKA1, Jin SUZUKI1, Akiko INOMATA2, Takako MORIYASU2

1Division of Toxicology, Department of Pharmaceutical and Environmental Sciences, Tokyo Metropolitan Institute of Public Health, 2Department of Pharmaceutical and Environmental Sciences, Tokyo Metropolitan Institute of Public Health

P-85 InvitroEvaluationofAcetyl-CoACarboxylaseInhibitor-MediatedDevelopmentalToxicity○ Yuji ISOBE1, Sarah N CAMPION2, Christine M STETHEM2, Gregg D CAPPON2

1DSRD-Tokyo, Drug Safety Research & Development, Pfizer R&D Japan, 2Pfizer Inc., Groton, CT, USA

P-86S Decreasesinmicroglialactivityandabnormalbehaviorsinducedbydevelopmentalexposuretoneonicotinoids○ Kaede NAMBA, Yasuhiro ISHIHARA

Program of Biomedical Science, Graduate School of Integrated Science for Life, Hiroshima University

P-87E Maternalexposureeffectofglyphosateandglyphosate-basedherbicideonhippocampalneurogenesisinrats○ Ryota OJIRO1, 2, Hiromu OKANO1, 2, Kazumi TAKASHIMA1, 2, Yasunori TAKAHASHI1, 2, Qian TANG1, 2, Satomi KIKUCHI1, 2, Toshinori YOSHIDA1, 2, Makoto SHIBUTANI1, 2

1Laboratory of Veterinary Pathology, Tokyo University of Agriculture and Technology, 2Cooperative Division of Veterinary Sciences, Graduate School of Agriculture, Tokyo University of Agriculture and Technology

P-88 PerinatalmethylphenidateexposureinducesADHD-likephenotypesanddecreased Drd2 and Slc6a3geneexpressionsinmouseoffspring○ Asuka KAIZAKI-MITSUMOTO1, 2, Satoru AOKI1, 2, Natsumi HATTORI-USAMI1, 2, Satoshi NUMAZAWA1, 2

1Division of Toxicology, Department of Pharmacology, Toxicology and Therapeutics, Showa University School of Pharmacy, 2Pharmacological Research Center, Showa University

P-89E Twenty-eight-dayrepeatedoraldosesofethanoldecreaseneuralstemcellstosuppressdifferentiationtoneuralprogenitorcellsaswellasreducedsynapticplasticityinadulthippocampalneurogenesisofpostpubertalrats○ Yasunori TAKAHASHI1, 2, Saori SHIMIZU1, Natsuno MAEDA1, Hiromu OKANO1, 2, Kazumi TAKASHIMA1, 2, Ryota OJIRO1, 2, Qian TANG1, 2, Satomi KIKUCHI1, 2, Toshinori YOSHIDA1, 2, Makoto SHIBUTANI1, 2

1Laboratory of Veterinary Pathology, Tokyo University of Agriculture and Technology, 2Cooperative Division of Veterinary Sciences, Graduate School of Agriculture, Tokyo University of Agriculture and Technology

P-90 Detectionofthalidomideinseminalplasmaafteroraldosesinmalerabbits○ Makiko KUWAGATA1, Hiromasa TAKASHIMA2, Ryo HANEDA2, Kanako TANAKA2, Takuro HASEGAWA3, Hiroshi YAMAZAKI4, Satoshi KITAJIMA1

1Division of Cellular and Molecular Toxicology, CBSR, National Institute of Health Sciences, 2The 1st Toxicology Division, Gotenba Laboratory, BoZo Research Center, 3Analysis Department, Tsukuba Laboratory, BoZo Research Center, 4Laboratory of Drug Metabolism and Pharmacokinetics, Showa Pharmaceutical University

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P-91 Germline-transmissionintheknock-inmiceofN0generationwithdiverseandunintendedon-targetmutationsinducedby CRISPR/Cas9-mediatedgenomeediting○ Toshime IGARASHI, Yukuto YASUHIKO, Ryuichi ONO, Erika TACHIHARA, Miki UCHIYAMA, Atsuya TAKAGI, Yu TAKAHASHI, Makiko KUWAGATA, Satoshi KITAJIMA

Division of Cellular & Molecular Toxicology, Center for Biological Safety & Research, National Institute of Health Sciences

P-92 Protectiveeffectsofα-glycosylisoquercitrinondisruptivehippocampalneurogenesiscausedbydevelopmentalexposuretovalproicacidinrats○ Kazumi TAKASHIMA1, 2, Hiromu OKANO1, 2, Qian TANG1, 2, Yasunori TAKAHASHI1, 2, Ryota OJIRO1, 2, Satomi KIKUCHI1, 2, Mihoko KOYANAGI3, Toshinori YOSHIDA1, 2, Makoto SHIBUTANI1, 2

1Laboratory of Veterinary Pathology, Tokyo University of Agriculture and Technology, 2Cooperative Division of Veterinary Sciences, Graduate School of Agriculture, Tokyo University of Agriculture and Technology, 3San-Ei Gen F.F.I., Inc.

P-93S Twenty-eight-dayrepeatedoralexposureeffectofaluminumchlorideonadulthippocampalneurogenesisinpostpubertalrats○ Saori SHIMIZU1, Natsuno MAEDA1, Yasunori TAKAHASHI1, 2, Qian TANG1, 2, Ryota OJIRO1, 2, Hiromu OKANO1, 2, Kazumi TAKASHIMA1, 2, Satomi KIKUCHI1, 2, Toshinori YOSHIDA1, 2, Makoto SHIBUTANI1, 2

1Laboratory of Veterinary Pathology, Tokyo University of Agriculture and Technology, 2Cooperative Division of Veterinary Sciences, Graduate School of Agriculture, Tokyo University of Agriculture and Technology

P-94S Twenty-eight-dayrepeatedoralexposureeffectofleadacetateonadulthippocampalneurogenesisinpostpubertalrats○ Natsuno MAEDA1, Saori SHIMIZU1, Yasunori TAKAHASHI1, 2, Qian TANG1, 2, Ryota OJIRO1, 2, Hiromu OKANO1, 2, Kazumi TAKASHIMA1, 2, Satomi KIKUTI1, 2, Toshinori YOSHIDA1, 2, Makoto SHIBUTANI1, 2

1Laboratory of Veterinary Pathology, Tokyo University of Agriculture and Technology, 2Cooperative Division of Veterinary Sciences, Graduate School of Agriculture, Tokyo University of Agriculture and Technology

P-95 Amelioratingeffectsofα-glycosylisoquercitrinonautismmodelinducedbyfetalLPSexposureinrats○ Hiromu OKANO1, 2, Kazumi TAKASHIMA1, 2, Yasunori TAKAHASHI1, 2, Ryota OJIRO1, 2, Qian TANG1, 2, Satomi KIKUCHI1, 2, Mihoko KOYANAGI3, Toshinori YOSHIDA1, 2, Makoto SHIBUTANI1, 2

1Laboratory of Veterinary Pathology, Tokyo University of Agriculture and Technology, 2Cooperative Division of Veterinary Sciences, Graduate School of Agriculture, Tokyo University of Agriculture and Technology, 3San-Ei Gen F.F.I., Inc.

P-96 Effectsofalowdoseoftetracyclinehydrochlorideonzebrafishbreeding○ Chelimuge QI, Hao CHEN, Xiaoyu YIN, Hongsong CHEN, Rigaiqiqige SA, Jingfeng YANG, Wu DONG

Collage of Animal Science and Technology, Inner Mongolia University for Nationalities

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GenetictoxicologyP-97 Establishmentoftestmethodandvalidationofevaluationcriteriafor

highsensitivityminiaturizedAmestest○ Asuka KOMATSU, Riko IWASAKI, Mitsuhide OGAWA, Yukiko OZEKI, Takuya KANNO, Masayuki KATO, Shigekazu SHIMIZU, Yasuki AKIE

CMIC Pharma Science Co., Ltd. CMIC Bioresearch Center

P-98 Investigationofin vivo genotoxicevaluationusingdetectionofγH2AXfollowing ocular instillation in rats○ Haruna TAHARA, Yoshinori YAMAGIWA, Kotaro YAMADA, Yu HARANOSONO, Masaaki KURATA

Senju Pharmaceutical Co., Ltd. Research & Development Division

P-99 Effectoflong-termcultureonvariationofchromosomenumberofclonesisolatedfromthio-dimethylarsinicacid-exposedcells○ Kayoko KITA, Naohiro MOROOKA, Susumu MIYAKE, Taro HONMA, Toshihide SUZUKI

Laboratory of Toxicology, Faculty of Pharma-Science, Teikyo University

P-100S Studyon3D-skinaccumulationandinvitrogenotoxicityof ortho-Phenylenediamine○ Yonggang QI1, 2, Tatsushi TOYOOKA2, Hiroki KASHIWAGI2, Rui-Sheng WANG2, Shigeki KODA2, Hyogo HORIGUCHI1

1Department of Hygiene, Kitasato University School of Medicine, 2National Institute of Occupational Safety and Health, Japan

CarcinogenicityP-101S Activationofnuclearreceptorsbynon-genotoxiclivercancer-inducing

chemicals○ Yoshie MIURA, Ryota SHIZU, Takumi SATO, Takuomi HOSAKA, Youichiro KANNO, Kouichi YOSHINARI

Laboratory of Molecular Toxicology, School of Pharmaceutical Sciences, University of Shizuoka

P-102 EvaluationoftheusefulnessofEpCAMandCD13asbiomarkersforthedetection of liver carcinogens○ Jun-ichi AKAGI, Young-Man CHO, Takeshi TOYODA, Yasuko MIZUTA, Mizuki SONE, Kumiko OGAWA

Division of Pathology, National Institute of Health Sciences

P-103E Investigationsofthemechanismsofacetamide-inducedhepatocarcinogenesisbasedontheratstraindifferencesofcarcinogenicity○ Kenji NAKAMURA1, 2, Yuji ISHII1, Tsuyoshi KAWAKAMI3, Maiko TAHARA3, Shinji TAKASU1, Moeka NAMIKI1, Makoto SHIBUTANI2, Kumiko OGAWA1

1Division of Pathology, National Institute of Health Sciences, 2Laboratory of Veterinary Medicine, Tokyo University of Agriculture and Technology, 3Division of Environmental Chemistry, National Institute of Health Sciences

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P-104 Relationshipbetweenurinarybladdercarcinogenicityandurinarymetabolitesofoccupationalurinarybladdercancer-relatedaromaticamines○ Shugo SUZUKI, Min GI, Masaki FUJIOKA, Anna KAKEHASHI, Hideki WANIBUCHI

Department of Molecular Pathology, Osaka City University Graduate School of Medicine

P-105 Anultra-short-termratmodelfordetectinggenotoxichepatocarcinogens○ Min GI1, Shugo SUZUKI2, Masaki FUJIOKA2, Hideki WANIBUCHI2

1Department of Environmental Risk Assessment, Osaka City University Graduate School of Medicine, 2Department of Molecular Pathology, Osaka City University Graduate School of Medicine

BehavioraltoxicologyP-106E Anattempttodetectpsychiatricadverseeventsbyevaluationofsocial

behaviorofpair-housingdogslivinginEUROGuide-compliantcages○ Miho MUKAI, Tamio FUKUSHIMA, Yoshiji ASAOKA, Yuuki KATOU

Laboratory for Drug Discovery and Development, Shionogi & CO., LTD.

P-107S Earlylifeexposuretoacephateexertstheneurobehaviorandgutmicrobiotainadultmice○ Takahiro SASAKI1, Ayano HASEGAWA1, Kazuya SAKAI1, Yuuki HIRADATE1, Kenshiro HARA1, Jahidul ISLAM2, Tomonori NOCHI2, Kentaro TANEMURA1

1Laboratory of Animal Reproduction and Development, Graduate School of Agricultural Science, Tohoku University, 2Laboratory of Functional Morphology, Graduate School of Agricultural Science, Tohoku University

P-108S Developmentaltoxicityofcefiximeontheembryonicearofzebrafish○ Bao CHAO, Nini BU, Shuaiyu WANG, Xiaoyu YIN, Hao CHEN, Wu DONG

Collage of Animal Science and Technology, Inner Mongolia University for Nationalities

ImmunotoxicologyP-109S Influenceoforalexposuretocitrininonthepathophysiologyinan

imiquimod-inducedmousemodelofpsoriasis○ Hiroki YAMAGUCHI1, Ryota AIHARA1, Naoki IWASHITA2, Yoshiichi TAKAGI3, Masayo KUSHIRO4, Tomoki FUKUYAMA1

1Laboratory of Veterinary Pharmacology, School of Veterinary Medicine, Azabu University, 2Bioalchemis, 3Japan SLC,Inc., 4Food Research Institute, National Agriculture and Food Research Organization

P-110S Influenceofsubacuteoralexposuretoinorganicarseniconpathologyofatopicdermatitisandallergicasthma○ Narumi KATO1, Yuri OGATA1, Naoki IWASHITA2, Yoshiichi TAKAGI3, Tomoki FUKUYAMA1

1Laboratory of Veterinary Pharmacology, School of Veterinary Medicine, Azabu University, 2Bioalchemis, 3Japan SLC, Inc.

P-111 Developmentofanassaytodeterminetheinnateimmune-stimulatingactivityofnucleicaciddrugcandidates○ Masamitsu ANDO, Tomoko HAYAKAWA, Takashi SASAKI, Chinami ARUGA, Tomomi TANIGUCHI

Discovery Technology Laboratories, Mitsubishi Tanabe Pharma Corporation

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P-112 Skimune®,aninvitrohumanskinexplantassaytopredictadverseimmunereactionsassociatedwithcytokinerelease○ Anne Mary DICKINSON, Shaheda AHMED

Alcyomics Ltd

DrugdependencyP-113 Acomparisonofself-administrationtrainingusingcocaineand

ketamine in rats○ Atsushi FUJIWARA, Masahiko IINO, Mikio SASAKI, Miki SHIMOSAWA, Naoya MUROTA, Shin-ichi SATO

Ina Research Inc.

CytotoxicityP-114S ElucidationofthetoxicmechanismsofpolypeptideantibioticpolymyxinB

○ Mayuka YAMADA, Yusuke HIRATA, Takuya NOGUCHI, Atsushi MATSUZAWA Lab. of Health Chem., Grad. Sch. of Pharmaceut. Sci., Tohoku Univ.

P-115 InteractionofautophagyinductionanderythropoietinproductionbyarsenateinHepG2cells○ Kazuhiko NISHIMURA, Reo INOUE, Kazuya OGAWA, Naotake KIRIYAMA, Anamul Md HAQUE, Hiroshi NAKAGAWA

Course of Veterinary Science, Graduate School of Life and Environmental Sciences, Osaka Prefecture University

P-116S AssessmentoftheWhith-EpidermalVesicleToxicityofSmallparticlesofTitaniumDioxideinMonolayerand3dReconstitutionSystemss○ Kenta SHISHIDO1, Noriko KEMURIYAMA3, Syuji OGAWA2, Yushi ASAOKA3, Kiri KOBAYASHI3, Katsuhiro MIYAJIMA1, 2, 3, Dai NAKAE1, 2, 3, Megumi YUKI4

1Department of Nutritional Science and Food Safety, Graduate School of Applied Biosciences,Tokyo University of Agriculture, 2Department of Food and Nutritional Science, Graduate School of Agriculture Tokyo University of Agriculture, 3Department of Nutritional Science and Food Safety, Faculty of Applied Biosciences, Tokyo University of Agriculture, 4Advantech Co., Ltd.

P-117S Tributyltininhibitsautophagyvialysosomaldysfunction○ Shunichi HATAMIYA1, Masatsugu MIYARA1, 2, 3, Yaichiro KOTAKE1

1Grad. Sch. of Biomed. and Health Sci., Hiroshima Univ., 2Gifu Pharm. Univ., 3JSPS Research Fellow PD

P-118 Evaluationoftheeffectsofpolystyreneparticlesonlysosomefunctionin Caco-2 cells○ Hiroshi NAKAGAWA, Kazuhiko NISHIMURA

Laboratory of Toxicology, Course of Veterinary Science, Graduate School of Life and Environmental Biosciences, Osaka Prefecture University

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Oxidative stressP-119 RoleofsulfanesulfurinPDGF-inducedvascularsmoothmusclecell

migration○ Takashi ASHINO1, 2, Shunichi ISHII1, 2, 3, Satoshi NUMAZAWA1, 2

1Division of Toxicology, Showa University School of Pharmacy, 2Pharmacological Research Center, Showa University, 3Department of Hospital Pharmaceutics, Showa University School of Pharmacy

MechanismsoftoxicityP-120S Elucidationofthemechanismsofrenaltoxicitycausedbypolypeptide

antibiotics○ Tomohiro KAGI, Rio NAGANUM, Aya INOUE, Yusuke HIRATA, Takuya NOGUCHI, Atsushi MATSUZAWA

Lab. of Health Chem., Grad. Sch. of Pharmaceut. Sci., Tohoku Univ.

P-121S Twodistinctmolecularmechanismsunderlyingthepro-apoptoticfunction of trans-fattyacidsinresponsetovarioustypesofDNAlesions○ Yuto YAMADA, Aya INOUE, Ryo ASHIDA, Yusuke HIRATA, Takuya NOGUCHI, Atsushi MATSUZAWA

Lab. of Health Chem., Grad. Sch. of Pharmaceut. Sci., Tohoku Univ.

P-122 Investigationofmechanismofliverinjuryinducedbycombinationimmunecheckpointinhibitortreatmentsinmice○ Tetsuki KATO1, Seda ARAT2, Heather LLEWELLYN2, Ji WEN2, Jingjin GAO2, Matt MARTIN2, Changhua JI2

1Pfizer R&D Japan, 2Pfizer Inc.

P-123 Cannabidiolicacidmediated-down-regulationofCOX-2expressionthroughtheabrogationofPPARβ/δsignaling○ Masayo HIRAO-SUZUKI1, Takayuki KOGA2, Genki SAKAI3, Masufumi TAKIGUCHI1, Akihisa TODA2, Narumi SUGIHARA3, Shuso TAKEDA3

1Faculty of Pharmaceutical Sciences, Hiroshima International University (HIU), 2Daiichi University of Pharmacy, 3Faculty of Pharmacy and Pharmaceutical Sciences, Fukuyama University

P-124 Individualvariationsingeneexpressionlevelsofmatrixmetalloproteinasesinhumantracheaandlung○ Naoya TAKAHASHI1, Koichiro NAKASHIMA1, Susumu OHKAWARA1, Ikuo KAWAMURA1, Nobuhiko MIURA1, Yoko MORI2, Takashi ISOBE1, Nobumitsu HANIOKA1, Hideto JINNO2, Toshiko TANAKA-KAGAWA1

1Laboratory of Environmental and Molecular Toxicology, Faculty of Pharmaceutical Sciences, Yokohama University of Pharmacy, 2Faculty of Pharmacy, Meijo University

P-125S Possibleinvolvementofplateletmitochondrialpermeabilitytransitioninacetaminophen-inducedliverinjury○ Yugo IKEYAMA, Akinori TAKEMURA, Kousei ITO

The Laboratory of Biopharmaceutics, Graduate School of Pharmaceutical Sciences, Chiba University

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P-126S Contributionofcaspase-8and/or-9inacetaminophen-inducedliverinjurydistinguishesthepotentialtocausetoxic-andimmunerelated-adverse event○ Koki ONISHI, Ryuji KATO, Yoshio IJIRI, Tetsuya HAYASHI, Kazuhiko TANAKA

Department of Cardiovascular Pharmacotherapy and Toxicology, Faculty of Pharmacy, Osaka Medical and Pharmaceutical University

P-127 Effectofthereceptorforadvancedglycationendproductsoncytotoxicityofdihydropyrazines○ Yuu MIYAUCHI1, Madoka SAWAI2, Takumi ISHIDA2, Hisao KANSUI3, Shinji TAKECHI 1

1Laboratory of Hygienic Chemistry, Faculty of Pharmaceutical Sciences, Sojo University, 2International University of Health and Welfare, School of Pharmacy at Fukuoka, 3Laboratory of Organic Chemistry, Faculty of Pharmaceutical Sciences, Sojo University

P-128S MethylmercuryinducestheexpressionofmetaltransporterZIP8byactivatingtheEGFR-p38MAPK-PKApathway○ Masaki YOSHIZAWA1, Keisuke ITO1, Tomoya FUJIE2, Chika YAMAMOTO2, Toshiyuki KAJI1

1Faculty of Pharmaceutical Sciences, Tokyo University of Science, 2Faculty of Pharmaceutical Sciences, Toho University

P-129S EffectofbenzbromaroneontheactivationofhepaticstellatecelllineLX-2○ Suzuna YAMASHITA, Akinori TAKEMURA, Kousei ITO

Biopharmaceutics Laboratory, Department of Pharmaceutical Sciences, Chiba University

CellularresponseP-130 Ouabagenin,anaglyconeofcardiotonicsteroidouabain,functionsas

LXRactivatorbutavoidstheincreaseintheexpressionofSREBP-1byinducingtheexpressionofKrüppel-likefactor15○ Tomofumi FUJINO, Kouta SUGIZAKI, Saki OHKAWA, Sana FUJIKAWA, Toshiyuki OSHIMA, Makio HAYAKAWA

Department of Hygiene and Health Sciences, School of Pharmacy, Tokyo University of Pharmacy and Life Sciences

P-131S Activationoftheunfoldedproteinresponseinducedbymethylmercuryinthemousebrain○ Ryosuke NOMURA1, Hideki HIRAOKA1, Yoshito KUMAGAI2, Masatake FUJIMURA3, Takashi UEHARA1

1Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Department of Medicinal Pharmacology, Okayama University, 2Environmental Biology Laboratory, Faculty of Medicine, University of Tsukuba, 3Toxicologic Pathology Section, Department of Basic Medical Science, National Institute for Minamata Disease

P-132S InvolvementofreactivesulfurspeciesinpromotionofvascularendothelialcellproliferationbyFGF-2○ Musubu TAKAHASHI1, Tomoya FUJIE2, Ayaka KUBOTA1, Ruri IWAI1, Chika YAMAMOTO2, Toshiyuki KAJI1

1Faculty of Pharmaceutical Science, Tokyo University of Science, 2Faculty of Pharmaceutical Sciences, Toho University

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P-133E AroleofPGRMC1,membrane-boundhemeprotein,oninductionofferroptosis○ Kazuma HIGASHISAKA1, Ying LIN1, Sachiyo HANAMURO1, Kohei IZUSAWA1, Hiroto KONISHI1, Yuya HAGA1, Hirofumi TSUJINO1, Kazuya NAGANO1, Yasuo TSUTSUMI1, 2

1Laboratory of Toxicology and Safety Science, Graduate School of Pharmaceutical Sciences, Osaka University, 2Global Center for Medical Engineering and Informatics, Osaka University

P-134 Automatedscreeningforangiogenicmodulationandtoxicityof1546compoundsonanOrgan-on-a-Chipplatform○ Sander P.M. DE RUITER, Camilla SORAGNI, Jeroen HEIJMANS, Arthur STOK, Thomas OLIVIER, Elvira VAN DER VIJVER, Sebastiaan TRIETSCH, Paul VULTO, Jos JOORE, Henriëtte LANZ

MIMETAS BV

P-135 Blood-brainbarrieron-a-chipforhighthroughputbarrierandtransportstudies○ Tania FOWKE, Nienke WEVERS, Arnaud NICOLAS, Arya Lekshmi NAIR, Maria PONTIER, Gwenaëlle RABUSSIER, Remko van VUGTH, Paul VULTO, Henriette LANZ

Mimetas BV

EpigeneticsP-136 Developmentofanewinvitroreportersystemfordetectionof

chemicalspotentiatingepigenetictoxicityonDNAmethylation○ Maky I. OTSUKA1, Misato MIYAI1, Naoki YAMAMOTO2, 3, Ayaka TSUCHIMOTO1, Hideki TAMURA1, 3, Kentaro TANEMURA4, Makoto SHIBUTANI5, 6, 7, Katsuhide IGARASHI1, 3

1Laboratory of Biofunctional Science, School of Pharmacy and Pharmaceutical Sciences, 2Department of Psychiatry, University of Texas Southwestern Medical Center, 3Institute for Advanced Life Sciences, Hoshi University, 4Laboratory of Animal Reproduction and Development, School of Agricultural Science, Tohoku University, 5Laboratory of Veterinary Pathology, Division of Animal Life Science, Institute of Agriculture, Tokyo University of Agriculture and Technology, 6Cooperative Division of Veterinary Sciences, Graduate School of Agriculture, Tokyo University of Agriculture and Technology, 7Institute of Global Innovation Research, Tokyo University of Agriculture and Technology

OmicsP-137 Comprehensiveproteinexpressionanalysisinrattestisatrepeated

administration of testicular toxicants○ Takuma TSUCHIYA1, Yuya HIDOH2, Norihiko TAKAHASHI1, Kaori ABE1

1Department of Investigative Toxicology, Nonclinical Research Center, Tokushima Research Institute, Otsuka Pharmaceutical Co., Ltd., 2Department of Drug Metabolism and Pharmacokinetics, Nonclinical Research Center, Tokushima Research Institute, Otsuka Pharmaceutical Co., Ltd.

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BiomarkersP-138 UseofcytochromeP4501Aexpressingtransgeniczebrafish

embryos/larvaetoassessdioxin-likecompoundsinBohaiBay○ Wenjing DONG1, 2, Xiaoyu YIN1, Jingfeng YANG1, De-Sheng PEI3, Hiroki TERAOKA2, Wu DONG1

1College of Animal Science and Technology, Inner Mongolia University for Nationalities/Inner Mongolia Key Laboratory of Toxicant Monitoring and Toxicology, 2School of Veterinary Medicine, Rakuno Gakuen University, 3Chongqing Institute of Green and Intelligent Technology, Chinese Academy of Sciences

P-139E HistopathologicalexaminationandevaluationofcirculatingmiRNAsasbiomarkersofpancreatictoxicityusingacutepancreatitismodelsinmice○ Seiichiro KURASHIGE1, Yuko TOGASHI1, Naomi MATSUTANI1, Masahiko KANEKO1, Yasuteru OTAGIRI1, Toyohiko AOKI2, Terutaka KODAMA1

1Research Institute, EA Pharma Co., Ltd., 2DIMS Institute of Medical Science, Inc.

P-140 Evaluationoffreshurineutilitytoexaminebiomarkersfornephrotoxicity○ Yuko DOI, Teruaki HAGIWARA, Norito AOYAMA, Mayumi KAWABE, Toyohiko AOKI

DIMS Institute of Medical Science, Inc.

P-141 Possibilityofprogesteroneanddehydroepiandrosteronesulfateasendogenous digitalis-like factors○ Yukari ONO, Tomoyo YAMAZAKI, Ryuji KATO, Yoshio IJIRI, Tetsuya HAYASHI, Kazuhiko TANAKA

Department of Cardiovascular Pharmacotherapy and Toxicology, Faculty of Pharmacy, Osaka Medical and Pharmaceutical University

P-142 PhenotypingofcytochromeP4503Aenzymesinindividualcynomolgusmonkeysbyendogenouscompoundsinplasmadeterminedbyliquidchromatography-massspectrometry○ Yasuharu NAKANISHI1, Katsunori IEKI1, Hiroshi KAMIMORI1, Takatoshi NAKAMURA1, Masahiro UTOH1, 2, Hiroshi YAMAZAKI2, Hideshi TSUSAKI1, 3

1Shin Nippon Biomedical Laboratories, LTD., 2Laboratory of Drug Metabolism and Pharmacokinetics, Showa Pharmaceutical University, 3Biomedical Research Laboratory, Gifu Pharmaceutical University

P-143 Plasmaphosphatidylcholineasapotentialbiomarkerforphospholipidosisinducedbyamitriptyline○ Kosuke FUKUDA, Kenichi WATANABE, Toichiro YAMADA, Sayo TAKAYAMA, Jun TADANO, Izuru MIYAWAKI

Preclinical Research Unit, Sumitomo Dainippon Pharma Co., Ltd.

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Toxicity-testingmethodsP-144 Effectofmicrosamplingmethodonorganismsandtoxicological

evaluation of mice○ Kazuaki TAKAHASHI, Yuki TOMONARI, Eiji MURATA, Keiko NAKAI, Dai YAMAMOTO, Takayuki OKAMURA, Atsushi IWAI, Munehiro NAKAGAWA

LSIM Safety Institute

P-145E Usefulnessofthepulseoximetermethodfortheevaluationofheartratein conscious rats○ Daigo IMOTO, Kenta WATANABE, Tadashi TSUBOUCHI, Kazuhiro CHIHARA, Izuru MIYAWAKI

Preclinical Research Unit, Sumitomo Dainippon Pharma Co., Ltd.

P-146E Evaluationofnewinvitroscreeningsystemtodetectdrug-inducedliverinjurybyusingnewcultureplatewithlowdrugadsorptionandhighoxygenpermeability○ Akinori TAKEMURA1, Sanae ISHII1, Hiroshi MIYASAKO2, Koji WAKABAYASHI2, Katsuhiro ESASHIKA2, Takashi KOUZEKI2, Tomohiro MATSUGI2, Toru HORIE3, Kousei ITO1

1Laboratory of Biopharmaceutics, Graduate School of Pharmaceutical Sciences, Chiba University, 2Mitsui Chemicals, Inc., 3DeThree Research Laboratories

P-147 Anti-AAVantibodymeasurementandpositiverateincynomolgusmonkeys○ Takeshi FUKUDA, Tatsuki NOMURA, Takahiro NAKAMURA, Hideshi TSUSAKI

Shin Nippon Biomedical Laboratories, Ltd.

P-148 AnattempttodeveloptheevaluationmethodforcalciumtransientinhumaniPScell-derivedcardiomyocytewithoutdedicateddevices○ Hiroki TAKASHIMA, Tomoyuki IJIRO, Yoshiyuki MOTOKAWA, Shinichi MUTO, Shinji SOUMA

Safety Research Department, Kissei Pharmaceutical Co., Ltd.

P-149E LowdensitycellcultureenhancestheformationoftightjunctionandhepaticfunctioninHepG2cells○ Rieko TANAKA1, Kazuko AIZAWA1, Manami ISO1, Kie SHIMIZU1, 2, Kazuaki NAKAMURA1

1National Center for Child Health and Development, 2Graduate School of Science and Engineering, Saitama University

P-150 Developmentalneurotoxicityassessmentofglutamatereceptorbindingagoniststhatcauselearningandmemoryimpairment:analysisofdrebrinimmunoreactivityinrathippocampalculturedneuron○ Shogo MASE1, 2, Izuo TSUTSUI1, Toshinari MITSUOKA1, Noriko KOGANEZAWA2, Hiroyuki YAMAZAKI2, Yuuichi KATO1, Hiroshi KAWABE2, Tomoaki SHIRAO2, Yuko SEKINO1

1Endowed Laboratory of Human Cell-Based Drug Discovery, Graduate School of Pharmaceutical Sciences, The University of Tokyo, 2Department of Pharmacology, Gunma University Graduate School of Medicine

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P-151E NephrotoxicitypredictionsystemusinghumanESandiPScells○ Hironori OTSUKI1, 2, Junko YAMANE2, Koji INOMATA1, Ayako MIWA1, Teppei SHIOJI1, Tetsuro ARAKI1, Masanori HIURA1, Wataru FUJIBUCHI2

1Toxicological Research Laboratories, Translational Research Unit, R&D Division, 2Center for iPS Cell Research and Application (CiRA), Kyoto University

P-152E Cell-basedinvitrohigh-throughputscreeningfortheevaluationofreactivemetaboliteformationpotential○ Kosuke HARADA1, Hiroshi KOHARA1, Tomoya YUKAWA1, Kouta MATSUMIYA2, Tadahiro SHINOZAWA1

1Drug Safety Research & Evaluation, Pharmaceutical Research Division, Takeda Pharmaceutical Company Limited, 2Drug Metabolism & Pharmacokinetics Research Laboratories

AnalyticalmethodP-153S Developmentofahybridanalyticalmethodandanapplicationof

heavymetalscombiningelementalimagingandlocalspeciationforenvironmentaltoxicology○ Makiko IWASE, Yasunori FUKUMOTO, Yu-ki TANAKA, Noriyuki SUZUKI, Yasumitsu OGRA

Graduate School of Pharmaceutical Sciences, Chiba University

P-154E SimultaneousDetectionTechniqueandChronicLow-doseAccumulationTrendsofImidaclopridanditsMetabolitesinTissuesofC57BL/6JMice○ Collins NIMAKO1, Yoshinori IKENAKA1, 2, 8, Osei AKOTO4, Kazutoshi FUJIOKA3, Kumiko TAIRA5, Koji ARIZONO6, Keisuke KATO7, Keisuke TAKAHASHI7, Shouta M.M. NAKAYAMA1, 7, Takahiro ICHISE1, Mayumi ISHIZUKA1

1Laboratory of Toxicology, Department of Environmental Veterinary Sciences, Faculty of Veterinary Medicine, Hokkaido University, Japan, 2Water Research Group, Unit for Environmental Sciences and Management, North-West University, Potchefstroom, South Africa, 3Pharmaceutical Research Institute, Albany College of Pharmacy and Health Sciences, USA, 4Chemistry Department, Kwame Nkrumah University of Science and Technology, Ghana, 5Department of Anesthesiology, Tokyo Women’s Medical University Center East, Japan, 6Faculty of Environmental and Symbiotic Sciences, Prefectural University of Kumamoto, Japan, 7Faculty of Pharmaceutical Sciences, Toho University, Japan, 8Translational Research Unit, Veterinary Teaching Hospital, Faculty of Veterinary Medicine, Hokkaido University, Japan

ToxicologicpathologyP-155 Investigationofbleomycin-inducedpulmonaryfibrosismodelusing

mice○ Takamasa NUMANO, Taiki SUGIYAMA, Tomomi HARA, Norio IMAI, Akihiro HAGIWARA, Hiroto MIYATA

DIMS Institute of Medical Science, Inc.

P-156 Histopathologicalandimmunohistochemicalevaluationofchangesinbloodhormonelevelsinducedbyendocrinedisruptors○ Hirotoshi AKANE1, Takeshi TOYODA1, Yasuko MIZUTA1, Tadashi KOSAKA2, Hitoshi TAJIMA2, Hiroaki AOYAMA2, Kumiko OGAWA1

1Division of Pathology, National Institute of Health Sciences, 2The Institute of Environmental Toxicology

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P-157 INHAND:InternationalHarmonizationofNomenclatureandDiagnosticCriteriaforLesions-AnUpdate2021○ Shim-mo HAYASHI1, CM KEENAN2, A BRADLEY3, DG GOODMAN4, Takanori HARADA5, R HERBERT6, Hijiri IWATA7, M JACOBSEN8, R KELLNER9, B MAHLER6, E MESECK10, T NOLTE11, S RITTINGHAUSEN9, J VAHLE12, Katsuhiko YOSHIZAWA13

1National Institute of Health Sciences, 2CM Keenan ToxPath Consulting, 3Charles River, 4Independent Consultant, 5The Institute of Environmental Toxicology, 6National Institute of Environmental Health Sciences, 7LunaPath LLC, 8Astra Zeneca, 9Fraunhofer ITEM, 10Novartis, 11Boehringer Ingelheim, 12Eli Lily, 13Mukogawa Women's University

Alternatives to mammalian modelsP-158E Characteristicsofsmallintestinalepithelialcellsderivedfromhuman

inducedpluripotentstemcellsandusefulnessasanin vitro model for gastrointestinaltoxicityevaluation○ Yuki IMAKURA1, Shinji MIMA1, Nao YAMAZAKI1, Seiichi MOCHIZUKI1, Akira INOMATA1, Takahiro IWAO2, Tamihide MATSUNAGA2, Kozo NAGATA1, Masahiko TANIGUCHI1

1Bio Science & Engineering Laboratory, FUJIFILM Corporation, 2Department of Clinical Pharmacy, Graduate School of Pharmaceutical Sciences, Nagoya City University

P-159 NextGenerationSafetyAssessmentofCosmetics-Read-acrosswith200 million chemicals-○ Hirokazu KOUZUKI1, Tomomi ATOBE1, Shuichi SEKINE1, Tomoka HISAKI1, Hanae KOBAYASHI1, Tadahaya MIZUNO2, Hiroyuki KUSUHARA2

1Shiseido Global Innovation Center, 2Graduate School of Pharmaceutical Sciences, The University of Tokyo

P-160 Useofread-acrossforthephotosensitizationassessmentofcosmetics○ Hanae KOBAYASHI1, Tomomi ATOBE1, Shuichi SEKINE1, Tomoka HISAKI1, Tadahaya MIZUNO2, Hiroyuki KUSUHARA2, Hirokazu KOUZUKI1

1Shiseido Global Innovation Center, 2Graduate School of Pharmaceutical Sciences, The University of Tokyo

P-161E DevelopmentofthemethodtoidentifyadductsformedbyNAC/NALandtestsubstances,andoxidationproductsofNACinADRAreactionsolutionsbyhigh-resolutionLC-MSanalysis○ Kohei KAMIYA1, Yasushi MISAWA1, Mamoru SUGIHARA2, Megumi NAKASHIMA2, Kazuya TAKEUCHI1, Satoshi FURUKAWA1

1Nissan Chemical Corporation, 2ALBION Co., Ltd

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P-162 NextGenerationSafetyAssessmentofCosmetics-ComprehensiveRead-acrossinSkinSensitizationAssessment-○ Tomomi ATOBE1, Shuichi SEKINE1, Tomoka HISAKI1, Tadahaya MIZUNO2, Hiroyuki KUSUHARA2, Hirokazu KOUZUKI1

1Shiseido Global Innovation Center, 2Graduate School of Pharmaceutical Sciences, The University of Tokyo

P-163 NextGenerationSafetyAssessmentofCosmetics-PotentialofTranscriptomeAnalysisinCardiacToxicityPrediction-○ Shuichi SEKINE1, Tomoka HISAKI1, Tomomi ATOBE1, Tadahaya MIZUNO2, Hiroyuki KUSUHARA2, Hirokazu KOUZUKI1

1Shiseido Co. Ltd. Global Innovation Center, 2Graduate School of Pharmaceutical Sciences, The University of Tokyo

P-164 NextGenerationSafetyAssessmentofCosmetics-PotentialofTranscriptomeAnalysisinDevelopmentalToxicityPrediction-○ Tomoka HISAKI1, Tomomi ATOBE1, Shuichi SEKINE1, Tadahaya MIZUNO2, Hiroyuki KUSUHARA2, Hirokazu KOUZUKI1

1Shiseido Global Innovation Center, 2Graduate School of Pharmaceutical Sciences, The University of Tokyo

P-165 Evaluationofdrugsusceptibilityusingthecellculturebyparticlecountinganalyzer○ Yasunori ODA

Sysmex Corporation R&I Business Development

P-166E DevelopmentofanAlternativeOralMucosalIrritationTestUsingaThree-dimensionalHumanBuccalOralMucosalModel-VerificationofCriteriaforIrritant/Non-IrritantClassification-○ Seiya AIZAWA1, Hidenori YOSHIDA2, Kazuhiko UMESHITA3, Shinichi WATANABE1, Yutaka TAKAHASHI2, Shinji SAKANE3, Hitoshi SAKAGUCHI2, Shinsuke KATAOKA1

1LION Corporation, Research & Development Headquarters, Safety Science Research Laboratories, 2Kao Corporation, R&D, Core Technology, Safety Science Research, 3Sunstar Inc., R&D Promotion Department, Safety/Analysis Laboratories

Animal modelP-167E Measurementofchemicalconcentrationsinzebrafishembryosexposed

tohuman/mammaldevelopmentaltoxicdrugs:drugdistributionandcomparisonwithhuman/mammalpharmacokineticparameters○ Tasuku NAWAJI1, 2, Naohiro MIZOGUCHI1, Masanori SEKI1, Hiroki TERAOKA2

1Chemicals Evaluation and Research Institute, Japan, 2School of Veterinary Medicine, Rakuno Gakuen University

P-168 MeasurementsofvolumeinGöttingenminipigsusingacomputedtomographyscanner○ Tadashi ITOH1, Tetsuya YAMADA1, Shinsuke SUZUKI1, Kazuko MIZUTANI1, Kota HAYAKAWA1, Takahito IMAIZUMI1, Tomonari KUBOTA1, Mifumi KAWABE2, Masafumi MIYOSHI3

1Nihon Bioresearch Inc., 2Animal Medical Center, Faculty of Applied Biological Sciences, Gifu University, 3Veterinary Medical Center, Obihiro University of Agriculture and Veterinary Medicine

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P-169 Myocardialinfarctionmodelinseverecombinedimmunodeficiencymice○ Tomoko NAGAO, Takuya AKASHI, Mina MATSUMOTO, Yoshizo FUKUDA, Hironobu IKEDA

Nissei Bilis CO.,LTD

P-170 Withdrawal P-171S AnalysisofACE2expressioninSDTfattyrats

○ Kinuko UNO1, Katsuhiro MIYAJIMA2, 3, Yurika ISHIDA2, Teppei UECHI2, Ayane YAMAGUCHI3, Kohei MANDAI3, Noriko KEMURIYAMA2, Masami SHINOHARA4, Tomohiko SASASE5, Takeshi OHTA5, Dai NAKAE2, 3

1Department of Food and Nutrition Science, Faculty of Agriculture, Graduate School of Tokyo University of Agriculture, 2Department of Nutritional Science and Food Safety, Faculty of Applied Bioscience, Undergraduate School of Tokyo University of Agriculture, 3Department of Nutritional Science and Food Safety, Faculty of Applied Bioscience, Graduate School of Tokyo University of Agriculture, 4Tokyo Animal & Diet Dept. CLEA japan, Inc., 5Laboratory of Animal Physiology and Functional Anatomy, Graduate School of Agriculture, Kyoto University

P-172 EffectsofpemafibrateonCDAHFD-inducedmurinenonalcoholicsteatohepatitis(NASH)model○ Toshinori MORITANI, Masanari YOSHIMOTO, Natsumi HAMADA, Wakana YAMASUGE, Noriko MINOBE, Shoko KOSUGI, Hitomi MATSUDA, Akihiro ISHIMOTO, Takashi KISE, Daisuke SAJI, Ayahito KIMURA

Shiga Laboratory, NISSEI BILIS Co., Ltd.

ClinicaltoxicologyP-173 Dimercaptosuccinicacidhadpositiveinhibitorypotencybutno

facilitatoryeffectagainstaberrantactivationofastrocytesexposedtodiphenylarsinicacid○ Takayuki NEGISHI1, Shoto SASAKI2, Ayaka SATO1, Marina KATO2, Hikari YOSHIDA1, Shuya WAKASUGI1, Takamasa TSUZUKI1, Kazunori YUKAWA1

1Department of Physiology, Faculty of Pharmacy, Meijo University, 2Department of Physiology, Graduate School of Pharmacy, Meijo University

P-174 Developmentofaninvitromodelofdrug-inducedtoxicepidermalnecrosis○ Anne Mary DICKINSON1, Shaheda AHMED1, D F CARR2, A OLSSON-BROWN2, M PIRMOHAMED2

1Alcyomics Ltd, 2University of Liverpool

Risk assessment and communicationP-175 Toxicitystudyofophthalmicdrugs;intravitrealadministrationdrugs

○ Kotaro YAMADA, Yoshinori YAMAGIWA, Yu HARANOSONO, Masaaki KURATA

Senju Pharmaceutical Co., Ltd. Research & Development Division

P-176 Applicationtotoxicityassessmentbasedonphysicalpropertiesofnanomaterials○ Akiko OHNO1, Masatoshi WATANABE2, Akihiko HIROSE1

1Division of Risk Assessment, National Institute of Health Sciences, 2Graduate School of Medicine, Mie University

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P-177 Riskassessmentofeye-dropdrugsforCNSeffects:Ageneralconsiderationonthebasisofexistinginformation○ Miki MASATSUGU, Kotaro YAMADA, Masaaki KURATA, Yu HARANOSONO

Central Research Laboratories, Research & Development Division, Senju Pharmaceutical Co., Ltd.

P-178 Hazardassessmentofbromodichloroaceticacid(BDCAA),anitemforFurtherStudyindrinkingwater○ Yasumasa MURATA, Yoshiyuki SHIGETA, Takako ISO, Nozomu HIROSE, Mariko MATSUMOTO, Akihiko HIROSE

National Institute of Health Sciences

P-179 Hazardassessmentofvinylacetate,anitemforFurtherStudyindrinking water○ Mariko MATSUMOTO, Yasumasa MURATA, Nozomu HIROSE, Yoshiyuki SHIGETA, Takako ISO, Akihiko HIROSE

Division of Risk Assessment, National Institute of Health Sciences, Japan

P-180 SettingofAcceptableSurfaceLimit(ASL)andOccupationalExposureBand(OEB)forSkinSensitizersusingEC1.6valuesderivedfromLLNA:BrdU-ELISA○ Asako FUKUSHIMA, Tae HAYASHI, Satoko ISHII, Masahiro TAKEYOSHI

Chemicals Evaluation and Research Institute, Japan

P-181 DevelopmentofanAutomatedTargetKnowledgeReviewApplicationtoAccelerateTargetSafetyEvaluations○ Masanori KOBAYASHI1, Masanori HIZUE1, Dennis J PELLETIER2

1Pfizer, Drug Safety Research & Development, Tokyo, 2Pfizer, Drug Safety Research & Development, Groton CT

P-182 Combinedrepeateddosetoxicitystudywiththereproduction/developmentaltoxicityscreeningtestof3-methylpentane,isooctane,and isononane in rats○ Akira KAWASHIMA, Kaoru INOUE, Yoshiro YOSHIZAKI, Kazuo USHIDA, Kaoru KAI, Hiroshi SUZUKI, Mariko MATSUMOTO, Takashi YAMADA, Akihiko HIROSE

Division of Risk Assessment, Biological Safety Research Center, National Institute of Health Sciences

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P-183 PossibilitytoutilizeteleworkintheGLPtestfacility○ Yushi MATSUO1, 2, Toshio OIMATSU1, 3, Hironobu OONISHI1, 4, Naoko KAWAGUCHI1, 5, Megumi KAWAMURA1, 6, Saori KOSUGI1, 16, Nana KOHARA1, 7, Koichi KONTANI1, 8, Fuminori KONDO1, 6, Yasumasa SASAKI1, 9, Aiko DAINI1, 10, Hideo TAKAGI1, 2, Nami TAKEUCHI1, 17, Maki TOMINAGA1, 11, Yoko NAGANO1, 12, Kouji NASU1, 13, Akira NOMURA1, Takenori MATSUMOTO1, 14, Hatsue YAMASHITA1, 15, Kazumi YOSHIDA1, 3

1Subgroup 1, Study Group 5 of GLP Division, Japan Society of Quality Assurance, 2Japan Tobacco Inc., 3ISHIHARA SANGYO KAISHA, LTD., 4NISSEI BILIS Co., Ltd., 5Fuso Pharmaceutical Industries, Ltd., 6Sumitomo Chemical Co., Ltd., 7SUMIKA TECHNOSERVICE CORPORATION, 8CMIC Pharma Science CO., Ltd., 9Santen Pharmaceutical Co., Ltd., 10Amato Pharmaceutical Products, Ltd., 11UBE Scientific Analysis Laboratory, Inc., 12DAIKEN MEDICAL CO., LTD., 13KAC Co., Ltd., 14ROHTO Pharmaceutical Co., Ltd., 15Otsuka Pharmaceutical Factory, Inc., 16Shin Nippon Biomedical Laboratories, Ltd., 17Menicon Co., Ltd.

P-184 Genotoxicityassessmentof4,4'-oxybis(benzenesulfonohydrazide): asubstancedesignatedinthepositivelistforfoodutensils,containerandpackaging○ Takako ISO1, Yasumasa MURATA1, Yoshiyuki SHIGETA1, Nozomu HIROSE1, Katsuyoshi HORIBATA2, Kenichi MASUMURA2, Kei-ichi SUGIYAMA2, Mariko MATSUMOTO1, Akihiko HIROSE1

1Division of Risk Assessment, National Institute of Health Sciences, 2Division of Genetics and Mutagenesis, National Institute of Health Sciences

P-185 Developmentofanewthresholdoftoxicologicalconcern(TTC)databaseofnon-cancertoxicityendpointsforindustrialchemicals○ Takashi YAMADA1, Masayuki KURIMOTO1, Akihiko HIROSE1, Chihae YANG2, 3, James F RATHMAN2, 3

1Division of Risk Assessment, National Institute of Health Sciences, 2Molecular Networks GmbH, 3Department of Chemical and Biomolecular Engineering, College of Engineering, The Ohio State University

P-186 IssuesofSENDreliabilityextractedbyquestionnaire○ Daisuke SASAKI1, Tomokazu SHIGEYAMA2, Terukazu KITAHARA3, Ryo OKUMURA4, Akiyoshi KURIHARA5

1Astellas Pharma Inc., 2Shin Nippon Biomedical Laboratories, Ltd., 3Instem Japan K.K., 4Kissei Pharmaceutical Co., Ltd., 5Taisho Pharmaceutical Co., Ltd.

P-187E SettingofpracticalGHS-subcategorizationcriterionforLLNA: BrdU-ELISA○ Hisako TANIGAWA, Toshio KOBAYASHI, Yosuke MAEDA, Haruka KONDO, Masahiro TAKEYOSHI

Chemicals Evaluation and Research Institute, Japan

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P-188 Developmentandrefinementofmechanism-basedhematotoxicitycategoriesforread-acrossassessmentusinganintegratedtoxicitydatabase○ Tomoko KAWAMURA, Takashi YAMADA, Shinji TSUJII, Hideo OHATA, Naruo KATSUTANI, Akihiko HIROSE

Division of Risk Assessment, Center for Biological Safety Research, National Institute of Health Sciences

P-189 Applicationofvariousparametersforquantitativeassessmentoncarcinogenicityintheprioritizationofriskassessmentforindustrialchemicals○ Kaoru INOUE, Kazuo USHIDA, Kaoru KAI, Hiroshi SUZUKI, Akira KAWASHIMA, Mariko MATSUMOTO, Takashi YAMADA, Akihiko HIROSE

Division of Risk Assessment, National Institute of Health Sciences

Informationtechnology,AI,andbigdataP-190 Developmentofinsilicopredictionmodelstoevaluatepharmacokinetic

profilesusingchemicalstructureinformation○ Reiko WATANABE1, Rikiya OHASHI1, 2, Masataka KURODA1, 2, Hiroshi KOMURA1, 4, Hitoshi KAWASHIMA1, Tsuyoshi ESAKI3, Yayoi NATSUME-KITATANI1, Kenji MIZUGUCHI1

1National Institute of Biomedical Innovation, Health and Nutrition, 2Mitsubishi Tanabe Pharma Corporation, 3Shiga University, 4Osaka City University

P-191E Detectionofbehavioralchangesinbeagledogsusingaccelerometers-Verificationofintroductionofsensingtechnologyforhigh-qualitysafetyevaluation-○ Misato TANAKA1, Takafumi SHIRAKAWA1, Tsuyoshi SAWABE3, Takashi MATSUDA3, Hitoshi NARAOKA2

1Drug Safety Research Laboratories, Drug Discovery Research, Astellas Pharma Inc., 2Drug Discovery Research, Astellas Pharma Inc., 3Advanced Informatics and Analytics, Astellas Pharma Inc.

P-192S Developmentofinsilicopredictionmethodfordrug-inducedliverinjuryusing in vitro test information○ Saki KATAYAMA

Regulatory Science, Graduate School of Pharmaceutical Sciences, Nagoya City University

P-193 VisualizationandAnalysisofNon-clinicalToxicologyStudyDataStandardizedusingSENDbyToxicologistsandDataScientists○ Takashi UOTA1, 2, Yoshifumi KANEKO1, 3, Yuta SAKAKIBARA1, 4, Gen SATO1, 5, Koichi SATO1, 6, Takashi TANAHARU1, 7, Atsushi HAMADA1, 8, Yasuhiro MASUZAKI1, 8, Tomoko MIHARA1, 6

1CDISC Japan User Group SEND team, 2CAC Croit Corporation, 3KYORIN Pharmaceutical Co.,Ltd., 4Kyowa Kirin Co., Ltd., 5Eisai Co., Ltd., 6Takumi Information Technology Inc., 7Bristol-Myers Squibb K.K., 8Japan Tobacco Inc.

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P-194 ChallengesandPracticalExamplesinCreationofSENDDataforDevelopmentalandReproductiveToxicityStudies○ Susumu SUYAMA1, Tadashi USHIMARU1, Konomi IINO1, Shin-ichi HORIKAWA1, Shin-ichi SATO1, Takayuki ANZAI2

1Ina Research Inc., 2Showa University School of Medicine

P-195 ElectronicdatamanagementusingtheCloud:HowtoensuretheGLPreliability?○ Tadahiro YOSHIYAMA, Hirokazu SUDO

Chugai Pharmaceutical Co., Ltd.

P-196 IssuesrelatedtocollaborationwithoutsourcingcontractorinthecreationofSENDdatapackagefornon-clinicalcontractresearchorganization(CRO)○ Kazuki SATO1, Misaki OHARA1, Kana NANAMI1, Daisuke MUKAI1, Masayo HOSOI1, Keiichi ITOH1, Shoji MASUMORI1, Koichi HAGITA1, Shin-ichi HORIKAWA2, Konomi IINO2, Atsushi UEMATSU2, Takayuki ANZAI3

1Toxicological laboratory for Small Animals, Research Division, BioSafety Research Center Inc., 2Ina Research Inc., 3Showa University School of Medicine

P-197S Thedevelopmentofin silico methodtopredicttheinhibitoryactivityofdrug-metabolizingenzyme○ Mizuki NAKAMORI1, Riku TOHNO1, Kaori AMBE1, Masahiro TOHKIN1, Takamitsu SASAKI2, Kouichi YOSHINARI2

1Regulatory Science, Graduate School of Pharmaceutical Sciences, Nagoya City University, 2Laboratory of Molecular Toxicology, School of Pharmaceutical Sciences, University of Shizuoka

P-198 QCautomationforSENDnumericaldatausingKNIME○ Kyotaka MUTA1, Kengo ARIYOSHI2, Keisuke KURAMOCHI2, Motoki ONO1, Naohito YAMADA1, Yasuhiro MASUZAKI1, Toshiyuki SHODA1

1Toxicology Research Laboratories, Central Pharmaceutical Research Institute, Japan Tobacco Inc., 2INFOCOM CORPORATION

P-199 UsefulnessofCJUGSENDchecktooltoensurethequalityofSENDdataset ○ Yasuhiro MASUZAKI1, 2, Atsushi HAMADA1, 2, Yoshihumi KANEKO1, 3, Junya MORITA1, 4, Koji AKIBA1, 5, Takashi UOTA1, 6, Dai YAMAMOTO1, 7, Koichi SATO1, 8, Koichi SUWA1, 9, Matsuki TSUCHIYA1, 10, Takayuki YASUDA1, 11, Shinichi HORIKAWA1, 12, Tadashi USHIMARU1, 12, Misa MATSUMURA1, 13, Yuta SAKAKIBARA1, 14

1CDISC Japan User Group SEND Team, Quality Control Subteam, 2Japan Tobacco Inc., 3KYORIN Pharmaceutical Co., Ltd., 4Taisho Pharmaceutical, Co., Ltd., 5Mitsui E&S Systems Research Inc., 6CAC Croit Corporation, 7LSIM Safety Institute Corporation, 8Takumi Information Technology Inc., 9BoZo Research Center Inc., 10FUJITSU LIMITED, 11Chugai Pharmaceutical Co., Ltd., 12Ina Research Inc., 13SHIONOGI & CO., LTD., 14Kyowa Kirin Co., Ltd.

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P-200 DevelopmentofAImodelforinferringgenotoxicity(AMES)usingkGCN○ Yoshinobu IGARASHI1, Ryosuke KOJIMA2, Yasushi OKUNO2, Hiroshi YAMADA1

1Toxicogenomics Informatics Project, National Institutes of Biomedical Innovation, Health and Nutrition, 2Department of Biomedical Data Intelligence, Graduate School of Medicine, Kyoto University

P-201 TranslationalSafetyCharts:VisualisingtheSafetyLifetimeofDrugsfromPreclinicalDiscoverytoPostmarketingSurveillanceRicard GARCIA-SERNA1, Montserrat CASES1, Nikita REMEZ1, Joaquim OLIVéS1, Oriol LóPEZ-MASSAGUER1, Maria C CARRASCOSA1, Antonino LATTENE1, Elisabet GREGORI-PUIGJANé1, Jordi MESTRES1, ○ Atsushi MIDORIKAWA2

1Chemotargets S.L., 2WorldFusion Co,. Ltd.

P-202S In-silicoAnalysesofDrug-inducedLiverMalignantTumorSignalsBasedonMolecularInitiatingEventsandMutagenicityUsingFDAAdverseEventReportingSystemDatabase○ Kota KUROSAKI, Yoshihiro UESAWA

Department of Medical Molecular Informatics, Meiji Pharmaceutical University

P-203 DiscussionofpointstoconsiderincreatingnSDRGofSENDdatasets-2-○ Miho IMAWAKA1, 2, Koshirou KATOKU1, 3, Yoshifumi KANEKO1, 4, Yuta SAKAKIBARA1, 5, Sayaka TAKAMI1, Koichi HASHIGUCHI1, 6, Atsushi HAMADA1, 7

1CDISC Japan User Group (CJUG) SEND team, nSDRG subteam, 2Axcelead Drug Discovery Partners, Inc., 3LSIM Safety Institute Corporation, 4KYORIN Pharmaceutical Co., Ltd., 5Kyowa Kirin Co., Ltd., 6Shin Nippon Biomedical Laboratories Co., Ltd., 7Japan Tobacco Inc.

OrganoidP-204 CocultureofCRCorganoidswithCAFsinducesre-expressionofREG

familyandDUOXs genes○ Mie NARUSE, Toshio IMAI

Central Animal Division, National Cancer Center Research Institute

P-205S Variousanalysesusingbladdercancerorganoidsderivedfrombladderlavagefluid○ Kodai FUJISAKA1, Mohamed ELBADAWY1, 2, Yomogi SATO1, Haru YAMAMOTO1, Hiroaki MATSUMOTO3, Hideyasu MATSUYAMA3, Masahiro KANEDA4, Tatsuya USUI1, Kazuaki SASAKI1

1Laboratory of Veterinary Pharmacology, Department of Veterinary Medicine, Faculty of Agriculture, Tokyo University of Agriculture and Technology, 2Department of Pharmacology, Faculty of Veterinary Medicine, Benha University, 3Department of Urology, Graduate School of Medicine, Yamaguchi University, 4Laboratory of Veterinary Anatomy, Department of Veterinary Medicine, Faculty of Agriculture, Tokyo University of Agriculture and Technology