親水性—親油性バランス型充填剤を用いる簡便な固相抽出精製による二枚貝中オカダ酸群の精密定量

鳥居塚 南¹, 上原 由理香¹, 長谷川 守文¹, 渡辺 卓穂, 鎗田 孝¹
分析化学誌, (2024) 73 (4.5), 185-191. https://doi.org/10.2116/bunsekikagaku.73.185
¹ 茨城大学農学部

動物実験代替法とNew Approach Methodologiesの開発・利用動向

第Ⅲ編　医療機器業界　第4章　医療機器の生物学的安全性評価における細胞毒性試験
渡辺美香
（書籍　シーエムシー出版　東京）, (2023)

　Laboratory Performance Study of the Japanese Official Method to Detect Genetically Modified Papaya Line PRSV-YK

Norihito SHIBATA¹,Toshiaki NAKASAKA, Jumpei NARUSHIMA¹, Chie TAGUCHI¹, Miyu SUGINO¹, Satoko YOSHIBA¹, Keisuke SOGA¹, Michika KAJIWARA, Takaho WATANABE, Kazunari KONDO^{1, 2}
食品衛生学雑誌, (2024) 65 (3), 61-66. https://doi.org/10.3358/shokueishi.65.61
¹ Division of Biochemistry, National Institute of Health Sciences
² Department of Food Safety and Management, Faculty of Food and Health Sciences, Showa Women's University

　The inter-laboratory validation study of EpiSensA for predicting skin sensitization potential

Mizumachi H¹, Watanabe M, Ikezumi M, Kajiwara M, Yasuda M, Mizuno M², Imai N², Sakuma M², Shibata M², Watanabe S², Motoyama J³, Basketter D⁴, Eskes C⁵, Hoffmann S⁶, Lehmann DM⁷, Ashikaga T⁸, Sozu T⁹, Takeyoshi M¹⁰, Suzuki S¹, Miyazawa M¹, Kojima H⁸
J. Appl. Toxicol., 2024 Apr;44(4):510-525. doi: 10.1002/jat.4559. Epub 2023 Oct 28..
¹ R&D Safety Science Research, Kao Corporation
² Safety and Analytical Research Laboratories, KOSÉ Corporation
³ Safety Research Science Laboratory, LION Corporation
⁴ DABMEB Consultancy Ltd.
⁵ Services and Consultation on Alternative Methods (SeCAM)
⁶ seh consulting + services
⁷ Office of Research and Development, US Environmental Protection Agency
⁸ Japanese Center for the Validation of Alternative Methods (JaCVAM), National Institute of Health Sciences
⁹ Department of Information and Computer Technology, Faculty of Engineering, Tokyo University of Science
¹⁰ Chemicals Assessment and Research Center, Chemicals Evaluation and Research Institute (CERI)

　ポリカーボネート製器具・容器包装の溶出試験における改良ビスフェノール A 分析法の室間共同試験

片岡洋平¹, 六鹿元雄¹, 阿部智之², 阿部　裕¹, 牛山温子³, 内山陽介⁴, 大野浩之⁵, 大橋公泰⁶, 風間貴充⁷, 木村亜莉沙⁸, 小林保志⁹, 近藤翠¹, 佐藤環¹⁰, 座間俊輔¹¹, 高橋良幸¹², 竹澤有紗¹³, 田中葵¹⁴, 照井善光¹⁵, 永井慎一郎¹⁶, 野村千枝¹⁷, 花澤耕太郎¹⁸, 早川雅人¹⁹, 平林尚之, 藤吉智治²⁰, 堀田沙希²¹, 宮川弘之²², 村山悠子²³, 四柳道代¹, 渡辺一成²⁴, 佐藤恭子¹
食品衛生学雑誌, (2023) 64(4), 154-160. https://doi.org/10.3358/shokueishi.64.154
¹ 国立医薬品食品衛生研究所
² (公社)日本食品衛生協会
³ 川崎市健康安全研究所
⁴ 神奈川県衛生研究所
⁵ 名古屋市衛生研究所
⁶ （一財）日本文化用品安全試験所
⁷ （一財）日本食品分析センター　多摩研究所
⁸ 静岡市環境保健研究所
⁹ 埼玉県衛生研究所
¹⁰ 福岡県保健環境研究所
¹¹ （一財）日本食品分析センター　彩都研究所
¹² (一財)千葉県薬剤師会検査センター
¹³ 長野県環境保全研究所
¹⁴ （一社）日本海事検定協会
¹⁵ （一財）日本食品検査
¹⁶ （一財）東京顕微鏡院
¹⁷ （地独）大阪健康安全基盤研究所
¹⁸ （一財）食品環境検査協会
¹⁹ （一財）化学研究評価機構 高分子試験・評価センター　大阪事業所
²⁰ （一財）食品分析開発センターSUNATEC
²¹ 愛知県衛生研究所
²² 東京都健康安全研究センター
²³ さいたま市健康科学研究センター
²⁴ (一財)化学研究評価機構 高分子試験・評価センター 東京事業所

　Bidirectional effects of voluntary exercise on the expression of Bdnf isoforms in the hippocampus of Hatano rat strains displaying different activity levels.

Chiba S¹, Asano H², Moriya S³, Hatakeyama T^2,4, Kobayashi S^2,4, Ohta R, Kawaguchi M²
Neuropsychopharmacol. Rep., 2023 Jan 17. doi: 10.1002/npr2.12313. Online ahead of print.
¹ Laboratory of Physiology, Faculty of Veterinary Medicine, Okayama University of Science
² Laboratory of Animal Behavior and Environmental Science, School of Agriculture, Meiji University
³ Department of Biochemistry and Genetics, Graduate School of Medicine, Chiba University
⁴ Organization for the Strategic Coordination of Research and Intellectual Property, Meiji University

　ポリカーボネート製器具・容器包装の溶出試験における改良ビスフェノール A 分析法の室間共同試験、日本食品化学学会誌

片岡洋平¹, 六鹿元雄¹, 阿部智之², 阿部　裕¹, 安藤景子³, 石原絹代⁴, 牛山温子⁵, 内山陽介⁶ 大坂郁恵⁷, 大野浩之⁸, 風間貴充⁹, 木村亜莉沙¹⁰, 佐藤　環¹¹, 高橋良幸¹², 田中　葵¹³, 棚橋高志¹⁴, 谷　拓哉¹⁵, 照井善光¹⁶, 外岡大幸¹⁷, 永井慎一郎¹⁸, 野村千枝¹⁹, 花澤耕太郎²⁰, 羽石奈穂子²¹, 早川雅人²², 平林尚之, 藤吉智治²³, 四柳道代¹, 渡辺一成²⁴, 佐藤恭子¹
日本食品化学学会誌, (2022) 29(3), 134-145
¹ 国立医薬品食品衛生研究所
² (公社)日本食品衛生協会
³ 長野県環境保全研究所
⁴ (一財)日本食品分析センター　彩都研究所
⁵ 川崎市健康安全研究所
⁶ 神奈川県衛生研究所
⁷ 埼玉県衛生研究所
⁸ 名古屋市衛生研究所
⁹ (一財)日本食品分析センター　多摩研究所
¹⁰ 静岡市環境保健研究所
¹¹ 福岡県保健環境研究所
¹² (一財)千葉県薬剤師会検査センター
¹³ (一社)日本海事検定協会
¹⁴ 愛知県衛生研究所
¹⁵ (一財)日本穀物検定協会
¹⁶ (一財)日本食品検査
¹⁷ さいたま市健康科学研究センター
¹⁸ (一財)東京顕微鏡院
¹⁹ (地独)大阪健康安全基盤研究所
²⁰ (一財)食品環境検査協会
²¹ 東京都健康安全研究センター
²² (一財)化学研究評価機構 高分子試験・評価センター 大阪事業所
²³ (一財)食品分析開発センター SUNATEC
²⁴ (一財)化学研究評価機構 高分子試験・評価センター 東京事業所

　Carbon monoxide combined with artificial blood cells acts as an antioxidant for tissues thermally-damaged by dye laser irradiation

Rikihisa N¹, Shimanouchi K², Saito Y, Sakai H³, Mitsukawa N⁴
Burns, 2022 Mar 19; S0305-4179(22)00063-8. doi: 10.1016/j.burns.2022.03.009.
¹ Oyumino Central Hospital
² Department of Plastic, Reconstructive, and Aesthetic Surgery, Chiba University Hospital
³ Department of Chemistry, Nara Medical University
⁴ Department of Plastic, Reconstructive Surgery, Chiba University Graduate School of Medicine

　Possible effects of voluntary exercise intensity on anxiety-like behavior and its underlying molecular mechanisms in the hippocampus: Results from a study in Hatano rats

Asano H¹, Moriya S², Hatakeyama T^1,3, Kobayashi S^1,3, Akimoto T¹, Ohta R, Kawaguchi M¹
Behav. Brain Res., 2022 Jun 3: 427:113854. doi: 10.1016/j.bbr.2022.113854. Epub 2022 Mar 19.
¹ Lab of Animal Behavior and Environmental Science, School of Agriculture, Meiji University
² Department of Biochemistry and Genetics, Chiba University Graduate School of Medicine
³ Organization for the Strategic Coordination of Research and Intellectual Property, Meiji University

　Artificial red blood cells increase large vessel wall damage and decrease surrounding dermal tissue damage in a rabbit auricle model after subsequent flashlamp-pumped pulsed-dye laser treatment

Shimanouchi K¹, Rikihisa N², Saito Y, Iuchi K³, Tsumura N³, Sakai H⁴, Mitsukawa N⁵
J. Dermatol., (2021): 48(5), 600-612. doi: 10.1111/1346-8138.15805. Epub 2021 Feb 25.
¹ Department of Plastic, Reconstructive, and Aesthetic Surgery, Chiba University Hospital
² Oyumino Central Hospital
³ Department of Imaging Sciences, Chiba University
⁴ Department of Chemistry, Nara Medical University
⁵ Department of Plastic, Reconstructive, and Aesthetic Surgery, Chiba University Graduate School of Medicine

　Rapeseed (canola) oil aggravates metabolic syndrome-like conditions in male but not in female stroke-prone spontaneously hypertensive rats (SHRSP)

Nishikawa M¹, Ohara N¹, Naito Y², Saito Y, Amma C¹, Tatematsu K³, Baoyindugurong J⁴, Miyazawa D¹, Hashimoto Y⁵, Okuyama H¹
Toxicol. Rep. 2022 Feb 7;9:256-268. doi: 10.1016/j.toxrep.2022.01.011. eCollection 2022.
¹College of Pharmacy, Kinjo Gakuin University
²School of Allied Health Sciences, Kitasato University
³Gifu Pharmaceutical University
⁴College of Food Science and Engineering, Inner Mongolia Agricultural University
⁵School of Dentistry, Aichi-Gakuin University

Dietary rapeseed (canola) oil suppresses testosterone production and increases plasma aldosterone level in stroke-prone spontaneously hypertensive rats (SHRSP)

Nishikawa M¹, Ohara N¹, Naito Y², Amma C¹, Saito Y, Tatematsu K³, Baoyindugurong J⁴, Miyazawa D¹, Hashimoto Y⁵, Okuyama H¹
Fundam. Toxicol. Sci., (2022): 9, 7-16
¹College of Pharmacy, Kinjo Gakuin University
²School of Allied Health Sciences, Kitasato University
³Gifu Pharmaceutical University
⁴College of Food Science and Engineering, Inner Mongolia Agricultural University
⁵School of Dentistry, Aichi-Gakuin University

　皮膚感作性試験代替法 Interleukin-8 Reporter Gene Assay(IL-8 Luc assay)評価報告書

小島幸一, 足利太可雄¹, 安達玲子¹, 佐藤一博², 瀬崎拓人³, 武吉正博⁴, 福山朋季⁵
AATEX-JaCVAM, (2021): 10(1), 49-68
¹国立医薬品食品衛生研究所
²国立大学法人　福井大学
³三井化学株式会社
⁴一般財団法人　化学物質評価研究機構
⁵麻布大学

　Effect of tris(1,3-dichloro-2-propyl) phosphate on epididymal sperm parameters in adult male rats

Kobayashi S^1,2, Kawano N³, Miyado K⁴, Ohta R, Akimoto T², Hatakeyama T^1,2, Kawaguchi M²
J. Vet. Med. Sci., (2022): 84, 153-156
¹Organization for the Strategic Coordination of Research and Intellectual Property, Meiji University
²Lab of Animal Behavior and Environmental Science, School of Agriculture, Meiji University
³Lab of Regulatory Biology, School of Agriculture, Meiji University
⁴Department of Reproductive Biology, National Research Institute for Child Health and Development

　Alterations between high and low-avoidance lines of Hatano ratsin learning behaviors, ultrasonic vocalizations, and histlogical characteristics in hippocampus and amygdala

Chiba S¹, Okawara T², Kawakami K², Ohta R, Kawaguchi M²
Physiol. Behav., 2022 Mar 1;245:113670. doi: 10.1016/j.physbeh.2021.113670.
¹Faculty of Veterinary Medicine, Okayama University of Science
²School of Agriculture, Meiji University

　Within- and between-laboratory reproducibility and predictive capacity of amino acid derivative reactivity assay (ADRA) using a 0.5 mg/mL test chemical solution: Results of the study for reproducibility confirmation implemented in five participating laboratories

Yamamoto Y¹, Fujita M¹, Watanabe S², Yamaga H², Wakabayashi K³, Tahara Y³, Horie N⁴, Fujimoto K⁴, Takeuchi K⁵, Kamiya K⁵, Kawakami T⁶, Kojima K, Sozu T⁷, Kojima H⁸, Kasahara T¹, Ono A⁹
J Appl Toxicol, (2022): 42, 1078-1090
¹Safety Evaluation Center, Fujifilm Corporation
²Safety Science Research Laboratories, Lion Corporation
³Chemical Safety Department, Mitsui Chemicals, Inc.
⁴Environmental Health Science Laboratory, Sumitomo Chemical Co., Ltd.
⁵Biological Research Laboratories, Nissan Chemical Corporation
⁶Division of Environmental Chemistry, National Institute of Health Sciences
⁷Faculty of Engineering, Tokyo University of Science
⁸Biological safety Research Center, Division of Risk Assessment, National Institute of Health Sciences
⁹Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Division of Pharmaceutical Sciences, Okayama University

　The within- and between-laboratories reproducibility and predictive capacity of Amino acid Derivative Reactivity Assay using 4 mM test chemical solution: Results of ring study implemented at five participating laboratories

Fujita M¹, Yamamoto Y¹, Wanibuchi S¹, Watanabe S², Yamaga H², Wakabayashi K³, Tahara Y³, Horie N⁴, Fujimoto K⁴, Takeuchi K⁵, Kamiya K⁵, Kawakami T⁶, Kojima K, Sozu T⁷, Kojima H⁸, Kasahara T¹, Ono A⁹
J Appl Toxicol, (2022): 42, 318-333
¹Safety Evaluation Center, Fujifilm Corporation
²Safety Science Research Laboratories, Lion Corporation
³Chemical Safety Department, Mitsui Chemicals, Inc.
⁴Environmental Health Science Laboratory, Sumitomo Chemical Co., Ltd.
⁵Biological Research Laboratories, Nissan Chemical Corporation
⁶Division of Environmental Chemistry, National Institute of Health Sciences
⁷Faculty of Engineering, Tokyo University of Science
⁸Biological safety Research Center, Division of Risk Assessment, National Institute of Health Sciences
⁹Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Division of Pharmaceutical Sciences, Okayama University

　Fully hydrogenated canola oil extends lifespan in stroke-prone spontaneously hypertensive rats

Tatematsu K¹, Miyazawa D², Saito Y, Okuyama H², Ohara N²
Lipids Health Dis., (2021): 20, 102, https://doi.org/10.1186/s12944-021-01540-7
¹Department of Radiochemistry, Gifu Pharmaceutical University
²Open Research Center for Lipid Nutrition, Kinjo Gakuin University College of Pharmacy

　Behavior of chemical respiratory sensitizers in in vitro methods for skin sensitization

Narita K, Okutomi H, Kawakami K, Sui H, Basketter D¹, Ashikaga T²
AATEX, (2021): 26, 9-18
¹DABMEB Consultancy Ltd.
²Division of risk assesment, National institute of heath sciences

食品中の栄養成分検査の技能試験 (2017-2018)

竹林純¹、高坂典子、鈴木一平¹、中阪聡亮、平林尚之、石見佳子^1,2、梅垣敬三^1,3、千葉剛¹、渡辺卓穂
食品衛生学雑誌、Vol.61 (2)、pp.63-71
¹ 国立研究開発法人医薬基盤・健康・栄養研究所　国立健康・栄養研究所
² 東京農業大学 総合研究所
³ 昭和女子大学 生活科学部 食安全マネジメント学科

　Novel toxicity of tris(1,3-dichloro-2-propyl) phosphate in adult male rats

Kobayashi S^1,2, Abe K², Isobe A², Nakayama A², Akimoto T², Hatakeyama T^1,2, Saito Y, Yanagisawa R³, Koike E³, Suzuki N³, Kawaguchi M², Ohta R
J Appl Toxicol, (2021) 41(6), 987-992
¹Organization for the Strategic Coordination of Research and Intellectual Property, Meiji University
²Lab of Animal Behavior and Environmental Science, School of Agriculture, Meiji University
³Center for Health and Environmental Risk Research, National Institute for Environmental Studies

医療機器の生物学的安全性試験

小島幸一
安全性試験の教育・研修テキスト
Vol.6、pp395-456

皮膚感作性試験代替法：ARE-Nrf2 luciferase LuSens Test Method

小島幸一、足利太可雄¹、安達玲子¹、佐藤一博²、瀬崎拓人³、武吉正博⁴、福山朋季⁵
AATEX-JaCVAM, (2020) 9(1), 43-57
¹国立医薬品食品衛生研究所
²国立大学法人　福井大学
³三井化学株式会社
⁴一般財団法人　化学物質評価研究機構
⁵麻布大学

　Maternal traits during lactation period reduce the anxiety-related behavior in male offspring:Results from a fostering study in Hatano rats

Horii Y¹, Nakajima S¹, Akieda-Asai S², Ohta R, Kawaguchi R¹
Physiol. Behav., (2021) Feb 1;229:113209.
¹School of Agriculture, Meiji University
²Frontier Science Research Center, University of Miyazaki

　The within- and between-laboratory reproducibility and predictive capacity of the in chemico amino acid derivative reactivity assay: Results of validation study implemented in four participating laboratories

Fujita M¹, Yamamoto Y¹, Watanabe S², Sugawara T², Wakabayashi K³, Tahara Y³, Horie N⁴, Fujimoto K⁴, Kusakari K⁵, Kurokawa Y⁵, Kawakami ⁶6, Kojima K, Sozu T⁷, Nakayama T⁷, Kusao T⁷, Richmond J⁸, Nicole K⁹, Kim BH¹⁰, Kojima H¹¹, Kasahara T¹, Ono A¹²
J Appl Toxicol (2019): 39(11):1492-1505. doi: 10.1002/jat.3834. Epub 2019 Jul 17.
¹Safety Evaluation Center, Fujifilm Corporation
²Human & Environmental Safety Evaluation Center, Lion Corporation
³Chemical Safety Department, Mitsui Chemicals, Inc.
⁴Environmental Health Science Laboratory, Sumitomo Chemical Co., Ltd.
⁵Biological Research Laboratories, Nissan Chemical Corporation
⁶Division of Environmental Chemistry, National Institute of Health Sciences
⁷Faculty of Engineering, Tokyo University of Science
⁸Dr. Jon Richmond: Advice and Consultancy
⁹NTP Interagency Center for the Evaluation of Alternative Toxicological Methods
¹⁰College of Natural Sciences Keimyung University
¹¹Biological Safety Research Center, Division of Risk Assessment, National Institute of Health Sciences
¹²Graduate School of Medicine, Dentistry and Pharmaceutical sciences, Division of Pharmaceutical Sciences, Okayama University

　Multi-laboratory validation study of the vitrigel-eye irritancy test method as an alternative to in vivo eye irritation testing

Kojima H¹, Yamaguchi H², Sozu T³, Kleinstreuer N⁴, Chae-Hyung L⁵, Chen W⁶, Watanabe M, Fukuda T⁷,Yamashita K⁸, Takezawa T⁹
ATLA, (2019): 47, 140?157
¹Japanese Center for the Validation of Alternative Methods (JaCVAM), National Institute of Health Sciences (NIHS), Kawasaki, Kanagawa, Japan
²Kanto Chemical Co., Inc., Isehara, Kanagawa, Japan
³Tokyo University of Science, Katsushika-ku, Tokyo, Japan
⁴Research Division, Chugai Pharmaceutical Co., LTD. Committee on the Validation of Alternative Methods (ICCVAM), Research Triangle Park, NC, USA
⁵Korean Center for the Validation of Alternative Methods (KoCVAM), National Institute of Food and Drug Safety Evaluation, Osong-eup, Chungcheongbuk-do, South Korea
⁶Industrial Technology Research Institute, (ITRI), Hsinchu, Taiwan
⁷Bozo Research Center (BRC), Setagaya-ku, Tokyo, Japan
⁸Daicel Corporation (Daicel), Himeji, Hyogo, Japan
⁹Institute of Agrobiological Sciences (NIAS), National Agriculture and Food Research Organization (NARO), Tsukuba, Ibaraki, Japan

　Historical control data on developmental toxicity studies in rats

Kuwagata M, Sakai Y¹, Tanaka S², Takashima H³, Katagiri R⁴, Matsuoka T⁵, Noritake K⁶, Senuma M, Shimizu T⁷, Hojo H⁸, Ibi K⁹, Kudo S¹⁰, Oota T¹¹, Ube M¹², Miwa Y¹³, Kajita S¹⁴, Uesugi T¹⁵, Yabe K¹⁶, Tateishi T¹⁷, Nakano N¹⁸, Taniguchi T¹⁹, Yamashita A²⁰, Hirano T²¹, Kirihata Y²², Sakai Y²³, Nishizawa S²⁷, Fujiwara M¹, Mineshima H²⁶, Horimoto M²⁵, Ema M²⁴
Congenit Anom Kyoto, (2019): 59, 125-131
¹Drug Safety Research Labs., Astellas Pharma Inc.
²Public Interest Incorporated Foundation, Biosafety Research Center
³Toxicology Department, GotembaLaboratory, BoZo Research Center Inc.
⁴National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM)/Interagency Coordinating
⁵Medicinal Safety Research Laboratories, Daiichi Sankyo Co., Ltd.
⁶Tsukuba, Drug Safety Eisai Co., Ltd.／Preclinical Safety Research Unit, Sunplanet Co., Ltd.
⁷Research administration Dept., Safety Research Center, Ina Research Inc.
⁸Laboratory of Reproductive and Developmental Toxicology, Toxicology Division, The Institute of Environmental Toxicology
⁹Pharmacokinetics and Safety Department Drug Research Center, Kaken Phamaceutical Co., Ltd.
¹⁰WATARASE Research Center, Kyorin Pharmaceutical Co., Ltd.
¹¹LSI Medience Corporation
¹²Safety Research Laboratories, Mitsubishi Tanabe Pharma Corporation
¹³Nihon Bioresearch Inc.
¹⁴Safety Research Laboratories, Ono Pharmaceutical Co., Ltd.
¹⁵Department of Drug Safety Research Nonclinical Research Center, Tokushima Research Institute, Otsuka Pharmaceutical Co., Ltd.
¹⁶Safety Research Institute for Chemical Compounds Co., Ltd
¹⁷Drug Safety Research Laboratories, Shin Nippon Biomedical Laboratories(SNBL), Ltd.
¹⁸Drug Safety Evaluation, Research Laboratory for Development, Shionogi& Co., Ltd.
¹⁹Environmental Health Science Laboratory, Sumitomo Chemical Co., Ltd.
²⁰Preclinical Reserch Unit, Sumitomo Dainippon Pharma Co., Ltd.
²¹Toxicology Laboratory, Taiho Pharmaceutical Co., Ltd.
²²Taisho Phamaceutical Co., Ltd.
²³Drug Safety Research Laboratories,Pharmaceutical Risearch Division, Takeda Phamaceutical Company, Ltd.
²⁴Research Institute of Science for Safety and Sustainability, National Institute of Advanced Industorial Science and Technology(AIST)
²⁵Faculty of risk and Crisis Management, Chiba Institute of Science
²⁶Tsukuba Drug Safety, Eisai Co,, Ltd.
²⁷Phamacology Research Department, Teijin Institutie for Biomedical Research, Teijin Pharma Limited

特例認定校卒業生として―実験動物技術者として原点―

村田龍介
LABI021, (2019): 78, pp 40

　Biological evaluation and regulation of medical devices in Japan

Kojima K, Sakaguchi K¹
Biocompatibility and Performance of Medical Devices, (2019): Woodhead Publishing; Second Edition
¹Terumo Co.

　Hatano rats selectively bred for high- and low-avoidance learning: an overview

Ohta R, Kojima K
Exp. Anim., (2019): 68, 127-136

Effect of essential oils contained linalool on skin sensitization using human cell line activation test

Doi M^{1, 2}, Watanabe M, Ariumi H¹, Yoshiyama Y¹
AATEX, (2019): 23, 9-15
¹Laboratory of Community Pharmacy, Division of Clinical Pharmacy, Research and Education Center for Clinical Pharmacy, School of Pharmacy, Kitasato University
²Medical System Network Corporation

　Method for combined observation of serial sections of stented arteries embedded in resin by light microscopy and transmission electron microscopy

Isobe A¹, Iwatani K¹, Souba J¹, Terao H¹, Hagiwara H¹, Kumagai F, Saito Y, Nagano K², Tasaki M¹
Toxicol Pathol, (2019): 47 (3), 401-407
¹Evaluation Center, R & D Administration and Promotion Department, Terumo Corporation
²Nagano Toxicologic-Pathology Consulting

Effects of pregnancy experience on ovarian senescence and longevity in Hatano rats bred for high- and low-avoidance learning

Ohta R, Ohmukai H
Exp. Gerontol., (2019): 117, 91-98

Enhancement of pesticide peak response in GC-MS in the presence of multiple co-existing reference pesticides

Yoshimitsu M¹, Akutsu K¹, Kitagawa Y¹, Takatori S¹、Fukui N¹ Osakada M¹, Yamaguchi S², Namikawa M³, Ban S³, Okubo Y⁴, Nakashima R⁴, Maruyama R⁴, Kakutani N¹, Miyamoto I¹, Yamashita K⁵, Nishiyama T⁵, Shinto M⁶, Yamamoto N⁶, Takai Y⁷, Hinoshita K⁸, Kajimura K¹, Obana H⁹, Watanabe T
Food Hyg. Saf. Sci., (2018): 59(3), 146-150
¹Osaka Institute of Public Health
²Osaka Prefecture Fujiidera Public Health Center
³Kyoto City Institute of Health and Environmental Sciences
⁴Kobe Institute of Health
⁵Nara Prefectural Institute of Health
⁶Sakai City Institute of Public Health
⁷Wakayama Prefectural Research Center of Environment and Public Health
⁸Wakayama Prefecture Shingu Public Health Center Kushimoto Branch Office
⁹San-Ei Gen F.F.I., Inc.

Comparison of assigned values from participants' results, spiked concentrations of test samples, and isotope dilution mass spectrometric results in proficiency testing for pesticide residue analysis

Yarita T¹, Otake T¹, Aoyagi Y¹, Takasaka N, Suzuki T, Watanabe T
Journal of AOAC International, (2018): 101(4), 1199-1204
¹National Metrology Institute of Japan

Development of enzyme-linked immunosorbent assay for analysis of total aflatoxins based on monoclonal antibody reactive with aflatoxins B1, B2, G1 and G2

Yamazaki T^{1, 2}, Miyake S^{2, 3, 4}, Sato N, Hirakawa Y^{1, 2}, Iwasa S⁵, Narita H¹, Watanabe T
Food Hyg. Saf. Sci., (2018): 59(5), 200-205
¹Kyoto Women’s University
²Advanced Science, Technology & Management Research Institute of Kyoto
³HORIBA, Ltd.
⁴Azabu University
⁵Toyohashi University of Tchnology

Intravenous injection of artificial red cells and subsequent dye laser irradiation causes deep vessel impairment in an animal model of port-wine stain

Rikihisa N¹, Tominaga M¹, Watanabe S², Mitsukawa N³, Saito Y, Sakai H⁴
Lasers Med Sci, (2018): 33(6), 1287-1293
¹Chiba Rosai Hospital
²Saitama Children’s Medical Center
³Department of Plastic, Reconstructive, and Aesthetic Surgery, Chiba University Graduate School of Medicine
⁴Department of Chemistry, Nara Medical University

Hatano rats are a suitable metabolic syndrome model for studying feeding behavior, blood pressure levels, and percent body fat

Isobe A¹, Shimada T^{2, 3}, Aburada M³, Yanagisawa R⁴, Sakawa T⁵, Nakamura T⁵, Himi TH³, Ohta R, Kawaguchi M^{1, 3}
J. Vet. Med. Sci., (2019): 81 (1), 147-154
¹Laboratory of Animal Behavior and Environmental Science, Graduate School of Agriculture, Meiji University
²Department of Hospital Pharmacy, University Hospital, Kanazawa University
³Musashino University
⁴Center for Health and Environmental Risk Research, National Institute for Environmental Studies
⁵Faculty of Pharmaceutical Sciences, Teikyo Heisei University

Male Hatano low-avoidance rats show more active sexual behavior with lower plasma testosterone than high-avoidance rats

Nakayama A¹, Okawa H², Zheng M^{3, 4}, Pu S^{3, 4}, Watanabe G^3,4,5, Ohta R, Kawaguchi M^{1, 2}
J. Vet. Med. Sci.,　(2018): 80(7), 1179-1182
¹Laboratory of Animal Behavior and Environmental Science, Graduate School of Agriculture, Meiji University
²Laboratory of Animal Behavior and Environmental Science, School of Agriculture, Meiji University
³Department of Basic Veterinary Science, United Graduate School of Veterinary Sciences, Gifu University
⁴Laboratory of Veterinary Physiology, Cooperative Department of Veterinary Medicine, Faculty of Agriculture, Tokyo University of Agriculture and Technology
⁵Basic Animal Medicine, Cooperative Division of Veterinary Sciences, Tokyo University of Agriculture and Technology

Transferability and within- and between-laboratory reproducibilities of EpiSensA for predicting skin sensitization potential in vitro: A ring study in three laboratories

Mizumachi H¹, Sakuma M², Ikezumi M, Saito K¹、Takeyoshi M², Imai N², Okutomi H, Umetsu A, Motohashi H, Watanabe M, Miyazawa M¹
J Appl Toxicol (2018): 38(9), 1233-1243
¹Kao Corporation, R&D, Safety Science Research
²KOSE Corporation, Research Laboratories

Cause of and countermeasures for oxidation of the cysteine-derived reagent used in the amino acid derivative reactivity assay

Fujita M¹, Yamamoto Y¹, Watanabe S², Sugawara T², Wakabayashi K³, Tahara Y³, Horie N⁴, Fujimoto K⁴, Kusakari K⁵, Kurokawa Y⁵, Kawakami T⁶, Kojima K, Kojima H⁷, Ono A⁸, Katsuoka Y¹, Tanabe H⁹, Yokoyama H⁹, Kasahara T¹
J Appl Toxicol, (2019): 39(2), 191-208
¹Fujifilm Corporation, Safety Evaluation Center
²Lion Corporation, Human & Environmental Safety Evaluation Center
³Mitsui Chemicals, Inc., Chemical Safety Department
⁴Sumitomo Chemical Co., Ltd., Environmental Health Science Laboratory
⁵Nissan Chemical Corporation, Biological Research Laboratories
⁶National Institute of Health Sciences, Division of Environmental Chemistry
⁷National Institute of Health Sciences, Biological safety Research Center, Division of Risk Assessment
⁸Okayama University, Graduate school of Medicine, Dentistry and Pharmaceutical sciences, Division of Pharmaceutical Sciences
⁹Fujifilm Corporation, Research & Development Management Headquarters, Analysis Technology Center, Kanagawa, Japan

Predictive performance and inter-laboratory reproducibility in assessing eye irritation potential of water- and oil-soluble mixtures using the Short Time Exposure test method

Abo T^{1, 2}, Hilberer A³, Behle-Wagner C⁴, Watanabe M, Cameron D⁵, Kirst A⁶, Nukada Y⁷, Yuki T⁷, Araki D¹, Sakaguchi H⁷, Itagaki H²
Toxicol In Vitro, (2018): 48, 78-85
¹Kao Corporation, Safety Science Research Laboratories, Odawara office
²Faculty of Engineering, Department of Materials Science and Engineering, Yokohama National University
³Institute for In Vitro Sciences, Inc.
⁴Envigo CRS GmbH
⁵Kao USA Inc.
⁶Kao Germany GmbH
⁷Kao Corporation, Safety Science Research Laboratories, Tochigi plant

ER STTA法：hERα-HeLa-9903細胞を用いたエストロゲン受容体恒常発現系転写活性化試験法の評価報告書

小野 宏、丸野内 棣¹, 井口 泰泉², 小野 敦³
AATEX-JaCVAM, (2017) Vol.6(1), pp.1-27
¹藤田保健大学
²基礎生物学研究所
³国立医薬品食品衛生研究所

再構築ヒト角膜様上皮モデル法（Reconstructed Human Cornea-like Epithelium Test Method:RhCE法）の評価報告書

竹内小苗¹, 小坂忠司², 佐々木正治³, 森村智美、吉村　功⁴
AATEX-JaCVAM, (2017) Vol.6(1), pp.28-36
¹P&Gイノベーション合同会社
²残留農薬研究所
³アッヴィ合同会社
⁴東京理科大学

皮膚感作性試験human Cell Line Activation Test (h-CLAT)の評価報告書

筒井尚久¹, 安達玲子², 金澤由基子, 小島幸一, 佐藤一博³, 武吉正博⁴, 森本隆史⁵
AATEX-JaCVAM, (2017) Vol.6(1), pp.37-50
¹田辺三菱製薬株式会社
²国立医薬品食品衛生研究所
³国立大学法人福井大学
⁴一般財団法人化学物質評価研究機構
⁵住友化学株式会社

生体吸収性材料で求められる生物学的安全性評価

小島幸一
生体吸収性材料の開発と安全性評価（書籍　技術情報協会　東京）, (2017): 392-400

医療機器の細胞毒性試験とin vitro遺伝毒性試験

山影康次
バイオマテリアル-生体材料-, (2017): 35, 210-215

Genetic variation in low-dose effects of neonatal DES exposure in female rats

Ohmukai H, Negura T, Tachibana S, Ohta R
Repro. Toxicol., (2017): 73, 322-327

Acute changes in histopathology and intravascular imaging after catheter-based renal denervation in a porcine model

Sakaoka A^{1, 2}, Takami A³, Onimura Y¹, Hagiwara H¹, Terao H¹, Kumagai F, Matsumura K²
Catheter. Cardiovasc. Interv.,　(2017): 90, 631-638
¹ R&D Headquarters, Terumo Corporation
² Graduate School of Engineering, Osaka Institute of Technology
³ Faculty of Medical Sciences, University of Fukui

Oral mucosal irritatrion study in hamster to evaluate a therapeutic apparatus using hydrogen peroxide photolysis for periodontitis treatment

Niwano Y¹, Konno K、Matayoshi T, Nakamura K¹, Kanno T¹, Sasaki K¹
Regul. toxicol. Pharmacol., (2017): 90, 206-213
¹ Tohoku University Graduate School of Dentistry

特集：食品製造現場における自主検査と精度管理
食品衛生精度管理比較調査（技能試験）結果の概要
技能試験結果の基本的な考え方

渡辺卓穂
クリーンテクノロジー, Vol. 27, No. 9, 14-18

Permeability of skin to silver nanoparticles after epidermal skin barrier disruption in rats

Kuwagata M, Kumagai F, Saito Y, Higashisaka K¹, Yoshioka Y^{1, 2}, Tsutsumi Y¹
Funsdam. Toxicol. Sci., (2017): 4 (3), 109-119
¹ Laboratory of Toxicology and Safety Science Graduate School of Pharmaceutical Science, Osaka University
² Vaccine Creation Project, BIKEN Innovative Vaccine Research Alliance Laboratories, Research Institute for Microbial Diseases, Osaka University

Artificial red blood cells as potential photosensitizers in dye laser treatment against port-wine stains

Rikihisa N¹, Watanabe S², Saito Y, Sakai H³
J. Funct. Biomater., (2017): 8 (14): doi:10.3390/jfb8020014
¹ Chiba Rosai Hospital
² Saitama Children's Medical Center
³ Department of chemistry, Nara Medical University

Evaluation of the matrix-like effect in multiresidue pesticide analysis by gas chromatography with tandem mass spectrometry

Akutsu K¹, Yoshimitsu M¹, Kitagawa Y¹, Takatori S¹, Fukui N¹, Osakada M¹, Yamaguchi S¹, Kajimura K¹, Obana H¹, Watanabe T
J. Sep. Sci., (2017): 40 (6), 1298-1300
¹ Department of Food, Drugs and Environment, Osaka Prefectural Institute of Public Health

Normal Ovarian Aging, but Modified T-cell Differentiation, in Female Mice following Neonatal Exposure to Bisphenol A

Ohta R, Ohmukai H, Negura T, Tazura Y, Shindo T
Fundam. Toxicol. Sci., (2017): 4 (1): 15-21

Photosensitizer effects of artifical red cells on dye laser irradiation in an animal model assuming port-wine stain treatment

Rikihisa N¹, Watanabe S², Satoh K³, Saito Y, Sakai H⁴
Plast. Reconstr. Surg.,(2017): 139 (3)：707e-716e
¹ Chiba Universiy
² Chiba rosai Hospital
³ Saitama Children's Medical Center
⁴ Nara Medical University

Correlation between luminescence intensity and cytotoxicity, and usefulness of internal control reporter in cytotoxicity assay using luciferase

Wakuri S, Yamakage K, Kazuki Y¹, Kazuki K¹, Oshimura M², Aburatani S³, Yasunaga M⁴, Nakajima Y¹
Anal. Biochem.,(2017): 522 (1)：18-29
¹ Chromosome Engineering Research Center, Tottori University
² Department of Biomedical Science, Institute of Regenerative Medicine and Biofunction, Graduate School of Medical Science, Tottori University
³ Biotechnology Research Institute for Drug Discovery, National Institute of Advanced Industrial Science and Technology (AIST)
⁴ Health Research Institute, National Institute of Advanced Industrial Science and Technology (AIST)

Thalidomide-induced limb abnormalities in a humanized CYP3A mouse model

Kazuki Y^1,2, Akita M³, Kobayashi K⁴, Osaki M^2,5, Satoh D², Ohta R, Abe S¹, Takehara S², Kazuki K², Yamazaki H⁶, Kamataki T⁷, Oshimura M²
　　Sci. Rep.,(2016): 6：21419
¹ Department of Biomedical Science, Institute of Regenerative Medicine and Biofunction, Graduate School of Medical Science
² Chromosome Engineering Research Center (CERC), Tottori University
³ Faculty of Family and Consumer Sciences, Department of Nutrition and Dietetics, Kamakura Women’s University
⁴ Graduate School of Pharmaceutical Sciences, Chiba University
⁵ Division of Pathological Biochemistry, Department of Biomedical Sciences, Faculty of Medicine, Tottori University
⁶ Showa Pharmaceutical University
⁷ Graduate School of Pharmaceutical Sciences, Hokkaido University

医療機器の生物学的安全性試験

小島幸一
安全性試験の教育・研修テキスト第５版, 安全性試験受託研究機関協議会, (2016)

第3章 外科材料･原料の各種評価と試験, 第４節 癒着防止材などで求められる生物学的安全性評価

小島幸一
手術用シーラント材・癒着防止材の利便化向上を目指した製品開発, 技術情報協会・東京, (2016)　pp.221-233

皮膚感作性試験ARE-Nrf2 Luciferase Test Method 角化細胞株レポーターアッセイ評価報告書

筒井尚久¹、安達玲子²、金澤由基子、小島幸一、佐藤一博³、武吉正博⁴、森本隆史^5
1 田辺三菱製薬（株）
² 国立医薬品食品衛生研究所
³ 国立大学法人福井大学
⁴ 一般財団法人化学物質評価研究機構
⁵ 住友化学（株）
AATEX-JaCVAM, (2016) 5巻, 1号：pp.1-11

眼刺激性試験代替法In Vitro短時間暴露法（Short Time Exposure In Vitro Test Method：STE法）の評価報告書

竹内小苗¹, 小坂忠司², 佐々木正治³, 森村智美, 吉村　功^4
1 P&Gイノベーション合同会社
² 残留農薬研究所
³ アッヴィ合同会社
⁴ 東京理科大学
AATEX-JaCVAM, (2016) 5巻、1号：pp.12-21

In vivo comet assay of acrylonitrile, 9-aminoacridine hydrochloride monohydrate and ethanol in rats

Nakagawa Y, Toyoizumi T, Sui H, Ohta R, Kumagai F, Usumi K, Saito Y, Yamakage K
Mutat Res Genet Toxicol Environ Mutagen,(2015): 786-788：104-113

JaCVAM-organized international validation study of the in vivo rodent alkaline comet assay for detection of genotoxic carcinogens: I. Summary of pre-validation study results

Uno Y¹, Kojima H²¹, Omori T³, Corvi R⁴, Honma M², Schechtman LM⁵, Tice RR⁶, Burlinson B⁷, Escobar PA⁸, Kraynak AR⁹, Nakagawa Y, Nakajima M¹⁰, Pant K¹¹, Asano N¹², Lovell D¹³, Morita T², Ohno Y², Hayashi M¹⁴
Mutat Res Genet Toxicol Environ Mutagen,(2015): 786-788：3-13
¹ Mitsubishi Tanabe Pharma Co.
² National Institute of Health Sciences
³ Kobe University Hospital(formerly Doshisha University, Kyoto)
⁴ Joint Research Centre of the European Commission
⁵ Innovative Toxicology Consulting
⁶ National Institute of Environmental Health Sciences
⁷ Huntingdon Life Sciences,
⁸ Boehringer Ingelheim Pharmaceuticals Inc.
⁹ Merck Research Laboratories
¹⁰ University of Shizuoka
¹¹ BioReliance
¹² Kinki University
¹³ St. George’s, University of London
¹⁴ Biosafety Research Center, Foods, Drugs and Pesticides

Evaluation of in vivo genotoxicity by thioacetamide in a 28-day repeated-dose liver micronucleus assay using male young adult rats

Sui H, Matsumoto H, Wako Y¹, Kawasako K¹
Mutat Res Genet Toxicol Environ Mutagen, (2015): 780-781：81-84
¹ LSI Medience Corporation

Evaluation of the repeated-dose liver micronucleus assay with p-dimethylaminoazobenzene

Shimada Y¹, Sui H, Wako Y², Kawasako K²
Mutat Res Genet Toxicol Environ Mutagen, (2015): 780-781：56-59
¹ Hokko Chemical Industry Co. Ltd.
² LSI Medience Corporation

II 試験法，第1 章　総論，5 精度管理（内部, 外部），2 外部精度管理

鈴木達也
食品衛生検査指針－微生物編－,(2015): 59-67

重金属を中心とする環境物質の免疫毒性研究とともに

大沢基保
ImmunoTox Letter,(2015): 20：2-4

Immunotoxicity of environmental substances with special reference to heavy metals： Toxicological properties and evaluation - Through with developing immunotoxicology of environmental heavy metals

Ohsawa M
ImmunoTox Letter, (2015): 20：8-9

Modifications of azoxymethane-induced carcinogenesis and 90-day oral toxicities of 2-tetradecylcyclobutanone as a radiolytic product of stearic acid in F344 rats

Sato M¹, Todoriki S², Takahashi T¹, Hafez E¹, Takasu C¹, Uehara H¹, Yamakage K, Kondo T³, Matsumoto K⁴, Furuta M⁵, Izumi K¹
J Toxicol Pathol,(2015): 28：99-107
¹ Institute of Health Biosciences, The University of Tokushima Graduate School
² National Food Research Institute
³ Graduate School of Medicine and Pharmaceutical Science, University of Toyama
⁴ Kyoto Sangyo University
⁵ Radiation Research Center, Osaka Prefecture University

Effects of arachidonic acid intake on inflammatory reactions in dextran sodium sulphateinduced colitis in rats

Naito Y^1,2, Ji X^1,3, Tachibana S, Aoki S, Furuya M, Tazura Y, Miyazawa D⁴, Harauma A⁵, Moriguchi T⁵, Nagata T, Iwai N¹, Ohara N⁴
Br. J. Nutr.,(2015): 114：734-745
¹ Department of Genomic Medicine, National Cerebral and Cardiovascular Center
² Department of Health Science, School of Allied Health Sciences and Graduate School of Medical Sciences, Kitasato University
³ State Key Laboratory of Phytochemistry and Plant Resources in West China, Kunming Institute of Botany, Chinese Academy of Sciences
⁴ College of Pharmacy, Kinjo Gakuin University
⁵ Department of Food and Life Science, School of Life and Environmental Science, Azabu University

In vitro and in vivo metabolism of N-adamantyl substituted urea-based soluble epoxide hydrolase inhibitors

Liua JY^1,2, Tsai HJ¹, Morisseau C¹, Lango J¹, Hwang SH¹, Watanabe T, Kim IH¹, Hammock BD¹
Biochem. Pharmacol.,(2015): 98：718-731
¹ Center for Nephrology and Clinical Metabolomics, Division of Nephrology and Rheumatology, Shanghai Tenth People's Hospital, Tongji University School of Medicine
² 2Department of Entomology and Nematology, and UC Davis Comprehensive Cancer Center, University of California, Davis

皮膚感作性試験Direct Peptide Reactivity Assay(DPRA)：ペプチド結合性試験評価報告書

筒井尚久¹、安達玲子²、金澤由基子、小島幸一、佐藤一博³、武吉正博⁴、森本隆史^5
1 田辺三菱製薬（株）
² 国立医薬品食品衛生研究所
³ 国立大学法人福井大学
⁴ 一般財団法人化学物質評価研究機構
⁵ 住友化学（株）
AATEX-JaCVAM, (2015) 4巻, 1号：pp.19-29

Tranexamic acid induces kaolin intake stimulating a pathway involving tachykinin neurokinin 1 receptors in rats

Kakiuchi H¹, Kawarai-Shimamura A², Kuwagata M, Orito K¹
Eur. J. Pharmacol., 2014; 723: 1-6
¹ Laboratory of Physiology II, Department of Veterinary Medicine, School of Veterinary Medicine, Azabu University
² Corporate Planning Department, Anicom Holdings, Inc.

Seeking genes responsible for developmental origins of health and disease from the fetal mouse liver following maternal food restriction

Ogawa T¹, Shibato J¹, Rakwal R^1,2,3, Saito T¹, Tamura G¹, Kuwagata M, Shioda S¹
Congenit Anom Kyoto, 2014; 54: 195-219
¹ Department of Anatomy, Showa University School of Mediciney
² Faculty of Life and Environmental Sciences
³ Organization for Educational Initiatives, University of Tsukuba

Ovarian dysfunction, obesity and pituitary tumors in female mice following neonatal exposure to low-dose diethylstilbestrol

Ohta R, Ohmukai H, Toyoizumi T, Shindo T, Marumo H, Ono H
Reprod. Toxicol., 2014; 50: 145-151

Early to middle gestational exposure to diethylstilbestrol impairs the development of labyrinth zone in mouse placenta

Kagawa N¹, Saito Y, Nagao T¹
Congenit Anom Kyoto, 2014; 54: 116-119
¹ Department of Life Science, Kinki University

Trehalose solution protects mesothelium and reduces bowel adhesions

Ohata A¹, Tamura N¹, Iwata K¹, Abe N¹, Doi K¹, Saito Y, Katoh M², Nojima H¹
J. Surg. Res., 2014; 191: 224-230
¹ Naruto Research Institute, Research and Development Center, Otsuka Pharmaceutical Factory, Inc.
² Study Department, Nihon Bioresearch Inc.

In vitro and in vivo evaluation of hemocompatibility of silk fibroin based artificial vascular grafts

Aytemiz D¹, Suzuki Y¹, Shindo T, Saotome T¹, Tanaka R², Asakura T¹
Int. J. Quant. Chem., 2014; 6: 1-14
¹ Department of Biotechnology, Tokyo University of Agriculture and Technology
² Division of Animal Life Science, Tokyo University of Agriculture and Technology

Development and performance evaluation of a positive reference material for hemolysis testing

Haishima Y¹, Hasegawa C¹, Nomura Y¹, Kawakami T², Yuba T³, Shindo T, Sakaguchi K⁴, Tanigawa T⁴, Inukai K⁴, Takenouchi M⁴, Isama K², Matsuoka A⁵, Niimi S¹
J. Biomed. Mater. Res. Part B Appl. Biomater., 2014; 102: 1809-1816
¹ Division of Medical Devices, National Institute of Health Sciences
² Division of Environmental Chemistry, National Institute of Health Sciences
³ Kawasumi Laboratories, Inc., Corporate Research and Development Division
⁴ R&D Headquarters, Evaluation Center, TERUMO Corporation
⁵ Office of Standards and Guidelines Development, Pharmaceuticals and Medical Devices Agency