᪂つヨ㦂ἲᥦ᱌᭩             ᖹᡂ  ᖺ  ᭶  ᪥                                  1R 
ගᏳ඲ᛶホ౯ἲ 526 ࢔ࢵࢭ࢖
࡟㛵ࡍࡿᥦ᱌ ᖹᡂ  ᖺ  ᭶  ᪥࡟ᮾிࠊᅜ❧་⸆ရ㣗ရ⾨⏕◊✲ᡤ࡟࡚㛤ദࡉࢀࡓ᪂つヨ㦂ἲホ౯఍㆟㸦㏻⛠㸸-D&9$0 ホ౯఍㆟㸧࡟࠾࠸࡚௨ୗࡢᥦ᱌ࡀ࡞ࡉࢀࡓࠋ   ᥦ᱌ෆᐜ㸸 526㸦5HDFWLYH2[\JHQ6SHFLHV㸧࢔ࢵࢭ࢖ࡣࠊ㐺⏝㝈⏺࡟␃ពࡍࢀࡤࠊග໬Ꮫ཯ᛂᛶ࡟㛵ࡋ࡚ഇ㝜ᛶࡢホ౯ࢆࡍࡿࡇ࡜ࡀ࡞࠸ࡇ࡜࠿ࡽࠊࡉࡽ࡞ࡿගᏳ඲ᛶホ౯ࡢせྰࡢุ᩿࡟฼⏝࡛ࡁࡿࠋ ᖺ࡟ᮏヨ㦂ἲࡣ་⸆ရࡢගᏳ඲ᛶホ౯࢞࢖ࢻࣛ࢖ࣥ࡜ࡋ࡚᥇ᢥࡉࢀࠊ᪤࡟⾜ᨻⓗ࡞ཷࡅධࢀࡀጞࡲࡗ࡚࠸ࡿࠋᮏヨ㦂ἲࢆගᏳ඲ᛶࡢホ౯ᡓ␎࡟⤌ࡳධࢀࡿࡇ࡜ࡣࠊ715837 ࡸࡑࢀ࡟⥆ࡃື≀ヨ㦂ࡢᐇ᪋ᩘࢆ๐ῶࡍࡿࡇ࡜࡟ࡘ࡞ࡀࡿࠋ໬⢝ရ࣭་⸆㒊እရཎᩱࠊ㎰⸆ࠊࡑࡢ௚୍⯡໬Ꮫ≀㉁࡟ࡘ࠸࡚ࡢගᏳ඲ᛶホ౯ἲ࡜ࡋ࡚ࠊ⾜ᨻୖࡢ฼⏝ࡀᮇᚅ࡛ࡁࡿࠋࡇࡢᥦ᱌᭩ࡣࠊ་⸆ရࡢගᏳ඲ᛶホ౯࢞࢖ࢻࣛ࢖ࣥࠊ526࢔ࢵࢭ࢖ࣂࣜࢹ࣮ࢩࣙࣥሗ࿌᭩࠾ࡼࡧ㛵㐃ㄽᩥࢆࡶ࡜࡟ࠊගẘᛶヨ㦂㈨ᩱ⦅⧩ጤဨ఍࡟ࡼࡾࡲ࡜ࡵࡽࢀࡓᩥ᭩ࢆ⏝࠸࡚ࠊ-D&9$0ホ౯఍㆟ࡀホ౯࠾ࡼࡧ᳨ウࡋࡓ⤖ᯝࠊࡑࡢ᭷⏝ᛶࡀ☜ㄆࡉࢀࡓࡇ࡜࠿ࡽసᡂࡉࢀࡓࠋ ௨ୖࡢ⌮⏤࡟ࡼࡾࠊ⾜ᨻᙜᒁࡢᏳ඲ᛶホ౯᪉ἲ࡜ࡋ࡚ගᏳ඲ᛶホ౯ἲ 526 ࢔ࢵࢭ࢖ࡢ౑⏝ࢆᥦ᱌ࡍࡿࡶࡢ࡛࠶ࡿࠋ ኱㔝Ὀ㞝                      すᕝ⛅ెᕝ⛅ెJaCVAM ホ౯఍㆟ ㆟㛗               JaCVAM 㐠Ⴀጤဨ఍ ጤဨ㛗i-D&9$0 ホ౯఍㆟኱㔝Ὀ㞝㸦㐠Ⴀጤဨ఍᥎⸀㸧㸸ᗙ㛗㣤ሯᑦᩥ㸦⊂❧⾜ᨻἲே ་⸆ရ་⒪ᶵჾ⥲ྜᶵᵓ㸧஬༑ᔒⰋ᫂㸦ᅜ❧་⸆ရ㣗ရ⾨⏕◊✲ᡤ ⏕ά⾨⏕໬Ꮫ㒊㸧▼஭㞝஧㸦ᅜ❧་⸆ရ㣗ရ⾨⏕◊✲ᡤ Ᏻ඲ᛶ⏕≀ヨ㦂◊✲ࢭࣥࢱ࣮ ⑓⌮㒊㸧ᒾ℩⿱⨾Ꮚ㸦᪥ᮏ〇⸆ᕤᴗ༠఍㸧㔠Ꮚ࿴ᘯ㸦᪥ᮏ໬Ꮫᕤᴗ༠఍㸧⠛⏣࿴ಇ㸦⊂❧⾜ᨻἲே ་⸆ရ་⒪ᶵჾ⥲ྜᶵᵓ㸧ᮡᒣ┿⌮Ꮚ㸦᪥ᮏ໬⢝ရᕤᴗ㐃ྜ఍㸧㇂ᕝᾈᏊ㸦᪥ᮏື≀ᐇ㦂௦᭰ἲᏛ఍㸧すᕝ⛅ె㸦ᅜ❧་⸆ရ㣗ရ⾨⏕◊✲ᡤ Ᏻ඲ᛶ⏕≀ヨ㦂◊✲ࢭࣥࢱ࣮㸧∾ ᰤ஧㸦᪥ᮏච␿ẘᛶᏛ఍㸧᳃⏣ ೺㸦᪥ᮏ⎔ቃኚ␗ཎᏛ఍㸧ᒣ⏣㝯ᚿ㸦⊂❧⾜ᨻἲே 〇ရホ౯ᢏ⾡ᇶ┙ᶵᵓ㸧ᶓ㛵༤㞝㸦᪥ᮏ⓶⭵࢔ࣞࣝࢠ࣮࣭᥋ゐ⓶⭵⅖Ꮫ఍㸧ྜྷ⏣Ṋ⨾㸦᪥ᮏẘᛶᏛ఍㸧ྜྷᮧ ຌ㸦ᗙ㛗᥎⸀㸧                  ௵ᮇ㸸ᖹᡂ 26 ᖺ 4 ᭶ 1 ᪥㹼ᖹᡂ 28 ᖺ 3 ᭶ 31 ᪥
ii

-D&9$0 㐠Ⴀጤဨ఍すᕝ⛅ె㸦ᅜ❧་⸆ရ㣗ရ⾨⏕◊✲ᡤ Ᏻ඲ᛶ⏕≀ヨ㦂◊✲ࢭࣥࢱ࣮㸧㸸ጤဨ㛗ᕝす ᚭ  㸦ᅜ❧་⸆ရ㣗ရ⾨⏕◊✲ᡤ㸧ᑠᕝஂ⨾Ꮚ 㸦ᅜ❧་⸆ရ㣗ရ⾨⏕◊✲ᡤ Ᏻ඲ᛶ⏕≀ヨ㦂◊✲ࢭࣥࢱ࣮ ⑓⌮㒊㸧ຍ⸨ ⠜㸦ᅜ❧ឤᰁ⑕◊✲ᡤ㸧Ⳣ㔝 ⣧㸦ᅜ❧་⸆ရ㣗ရ⾨⏕◊✲ᡤ Ᏻ඲ᛶ⏕≀ヨ㦂◊✲ࢭࣥࢱ࣮ ẘᛶ㒊㸧⠛⏣࿴ಇ㸦⊂❧⾜ᨻἲே ་⸆ရ་⒪ᶵჾ⥲ྜᶵᵓ㸧㛵㔝♸Ꮚ㸦ᅜ❧་⸆ရ㣗ရ⾨⏕◊✲ᡤ Ᏻ඲ᛶ⏕≀ヨ㦂◊✲ࢭࣥࢱ࣮ ⸆⌮㒊㸧㧗ᮌ⠜ஓ㸦ᅜ❧་⸆ရ㣗ရ⾨⏕◊✲ᡤ Ᏻ඲ᛶ⏕≀ヨ㦂◊✲ࢭࣥࢱ࣮ ẘᛶ㒊 ື≀⟶⌮ᐊ㸧᮰㔝ṇ᫂㸦ཌ⏕ປാ┬ ་⸆࣭⏕ά⾨⏕ᒁ໬Ꮫ≀㉁Ᏻ඲ᑐ⟇ᐊ㸧୰ᮧ㧗ᩄ㸦⊂❧⾜ᨻἲே ་⸆ရ་⒪ᶵჾ⥲ྜᶵᵓ㸧᪥⏣ ඘

㸦ཌ⏕ປാ┬ ་⸆࣭⏕ά⾨⏕ᒁ໬Ꮫ≀㉁Ᏻ඲ᑐ⟇ᐊ㸧ᗈ℩᫂ᙪ  㸦ᅜ❧་⸆ရ㣗ရ⾨⏕◊✲ᡤ Ᏻ඲ᛶ⏕≀ヨ㦂◊✲ࢭࣥࢱ࣮ Ᏻ඲ᛶணホ౯㒊㸧ᮏ㛫ṇ඘㸦ᅜ❧་⸆ရ㣗ရ⾨⏕◊✲ᡤ Ᏻ඲ᛶ⏕≀ヨ㦂◊✲ࢭࣥࢱ࣮ ኚ␗㑇ఏ㒊㸧⨾ୖ᠇୍㸦ཌ⏕ປാ┬ ་⸆࣭⏕ά⾨⏕ᒁ໬Ꮫ≀㉁Ᏻ඲ᑐ⟇ᐊ㸧୕⃝ 㤾㸦ཌ⏕ປാ┬ ་⸆࣭⏕ά⾨⏕ᒁᑂᰝ⟶⌮ㄢ㸧ᑠᓥ ⫕㸦ᅜ❧་⸆ရ㣗ရ⾨⏕◊✲ᡤ Ᏻ඲ᛶ⏕≀ヨ㦂◊✲ࢭࣥࢱ࣮ Ᏻ඲ᛶணホ౯㒊 ➨஧ᐊ㸧㸸஦ົᒁiii

iv

JaCVAM statement on the Reactive Oxygen Species (ROS) assay forphotosafety assessment
At a meeting held on 17 December 2015 at the National Institute of Health Sciences (NIHS)
in Tokyo, Japan, the Japanese Center for the Validation of Alternative Methods (JaCVAM)
Regulatory Acceptance Board unanimously endorsed the following statement:
Proposal: Provided that proper consideration is given to the limits of applicability, theReactive Oxygen Species (ROS) assay is a useful means of determining the needfor additional photosafety assessment, because it does not produce false negatives
regarding photochemical reactivity. Guidelines for the photosafety assessment ofdrugs using the ROS assay were approved in 2014 and are increasingly accepted
for regulatory use.
The incorporation of the ROS assay into photosafety assessment strategies can be
expected to help reduce the need for 3T3 NRU PT as well as follow-up testing
using animals. We look forward its use in a regulatory context for the photosafetyassessment of ingredients used in cosmetics and quasi-drugs, agriculturalchemicals, and other chemical substances.
This statement was prepared following a review of guidelines for the photosafety assessmentof drugs, the ROS Assay Validation Report, and related documentation and using materials
prepared by the Phototoxicity Testing JaCVAM Editorial Committee to acknowledge that theresults of a review and study by the JaCVAM Regulatory Acceptance Board haveacknowledged the usefulness of this assay.
Based on the above, we propose the ROS assay as a means for photosafety assessment insafety assessments by regulatory agencies.

Yasuo Ohno
Chairperson
JaCVAM Regulatory Acceptance BoardAkiyoshi Nishikawa
Chairperson
JaCVAM Steering Committee

20 January 2016v

The JaCVAM Regulatory Acceptance Board was established by the JaCVAM SteeringCommittee, and is composed of nominees from the industry and academia.
This statement was endorsed by the following members of the JaCVAM RegulatoryAcceptance Board:

Mr. Yasuo Ohno (nominee by JaCVAM Steering Committee) : Chairperson
Mr. Naofumi Iizuka (Pharmaceuticals and Medical Devices Agency)
Mr. Yoshiaki Ikarashi (National Institute of Health Sciences: NIHS)
Mr. Yuji Ishii (NIHS)
Ms. Yumiko Iwase (Japan Pharmaceutical Manufacturers Association)
Mr. Kazuhiro Kaneko (Japan Chemical Industry Association)
Mr. Eiji Maki (Japanese Society of Immunotoxicology)
Mr. Takeshi Morita (Japanese Environmental Mutagen Society)
Mr. Akiyoshi Nishikawa (NIHS)
Mr. Kazutoshi Shinoda (Pharmaceuticals and Medical Devices Agency)
Ms. Mariko Sugiyama (Japan Cosmetic Industry Association)
Ms. Koko Tanigawa (Japanese Society for Alternatives to Animal Experiments)
Mr. Takashi Yamada (National Institute of Technology and Evaluation)
Mr. Hiroo Yokozeki (Japanese Society for Dermatoallergology and Contact Dermatitis)
Mr. Takemi Yoshida (Japanese Society of Toxicology)
Mr. Isao Yoshimura (nominee by Chairperson)
Term: From 1st April 2014 to 31st March 2016vi

This statement was endorsed by the following members of the JaCVAM steering Committee
after receiving the report from JaCVAM Regulatory Acceptance Board:

Mr. Akiyoshi Nishikawa (BSRC, NIHS): Chairperson
Mr. Toru Kawanishi (NIHS)
Mr. Mitsuru Hida (Ministry of Health, Labour and Welfare)
Mr. Akihiko Hirose (Division of Risk Assessment, BSRC, NIHS)
Mr. Masamitsu Honma (Division of Genetics and Mutagenesis, BSRC, NIHS)
Mr. Jun Kanno (Division of Cellular and Molecular Toxicology, BSRC, NIHS)
Mr. Atsushi Kato (National Institute of Infectious Diseases)
Mr. Kenichi Mikami (Ministry of Health, Labour and Welfare)
Mr. Kaoru Misawa (Ministry of Health, Labour and Welfare)
Mr. Takatoshi Nakamura (Pharmaceutical & Medical Devices Agency)
Ms. Kumiko Ogawa (Division of Pathology, BSRC, NIHS)
Ms. Yuko Sekino (Division of Pharmacology, BSRC, NIHS)
Mr. Kazutoshi Shinoda (Pharmaceuticals and Medical Devices Agency)
Mr. Atsuya Takagi (Animal Management Section of the Division of Cellular andMolecular Toxicology, BSRC, NIHS)
Mr. Masaaki Tsukano (Ministry of Health, Labour and Welfare)Mr. Hajime Kojima (Section for the Evaluation of Novel Methods, Division of Risk
Assessment, BSRC, NIHS): Secretaryvii