᪂つヨ㦂ἲᥦ᱌᭩             ᖹᡂ  ᖺ  ᭶  ᪥                                  1R 

⓶⭵ឤసᛶヨ㦂௦᭰ἲ Direct Peptide Reactivity Assay (DPRA)㸸
࣌ࣉࢳࢻ⤖ྜᛶヨ㦂࡟㛵ࡍࡿᥦ᱌ ᖹᡂ 26 ᖺ 12 ᭶ 17 ᪥࡟ᮾிࠊᅜ❧་⸆ရ㣗ရ⾨⏕◊✲ᡤ࡟࡚㛤ദࡉࢀࡓ᪂つヨ㦂ἲホ౯఍㆟㸦㏻⛠㸸JaCVAM ホ౯఍㆟㸧࡟࠾࠸࡚௨ୗࡢᥦ᱌ࡀ࡞ࡉࢀࡓࠋ   ᥦ᱌ෆᐜ㸸 ࣌ࣉࢳࢻ⤖ྜᛶヨ㦂࡛㝧ᛶࡢ⤖ᯝࡀᚓࡽࢀࡓሙྜࠊࡑࡢ໬Ꮫ≀㉁ࢆᙉ࠸ឤసᛶ
≀㉁࡟ศ㢮ࡍࡿࡇ࡜ࡣ⾜ᨻୖྍ⬟࡛࠶ࡿࠋࡋ࠿ࡋ࡞ࡀࡽࠊࡲࢀ࡟ഇ㝧ᛶࡢ⤖ᯝࡀ⏕ࡌࡿࡇ࡜࡟␃ពࡋ࡞ࡅࢀࡤ࡞ࡽ࡞࠸ࠋ୍᪉ࠊ࣌ࣉࢳࢻ⤖ྜᛶヨ㦂ࡢ㝜ᛶ⤖ᯝࡀᚓࡽࢀࡓሙྜࠊࡑࡢ໬Ꮫ≀㉁ࡢ⓶⭵ឤసᛶࡣഇ㝜ᛶࡢྍ⬟ᛶࡀ࠶ࡾࠊDPRA ༢⊂࡛ࡑࡢ⓶⭵ឤసᛶࢆุᐃࡍࡿࡇ࡜ࡣ㞴ࡋ࠸ࠋࡑࡢ௚ࡢ᝟ሗ※࡜⤌ࡳྜࢃࡏ࡚ホ౯ࡍࡿࡇ࡜࡟ࡼࡾࠊ࣌ࣉࢳࢻ⤖ྜᛶヨ㦂ࡣ⾜ᨻⓗ࡟฼⏝ྍ⬟࡛࠶ࡿ࡜⪃࠼ࡿࠋࡇࡢᥦ᱌᭩ࡣࠊOECD TG 442C; In Chemico Skin Sensitisation: Direct Peptide Reactivity Assay(DPRA)࠾ࡼࡧ JRC Scientific and Policy report, EURL ECVAM Recommendation on theDirect Peptide Reactivity Assay (DPRA) for Skin Sensitisation Testingࢆࡶ࡜࡟ࠊ⓶⭵ឤసᛶヨ㦂㈨ᩱ⦅⧩ጤဨ఍࡟ࡼࡾࡲ࡜ࡵࡽࢀࡓᩥ᭩ࢆ⏝࠸࡚ࠊJaCVAMホ౯఍㆟ࡀホ౯࠾ࡼࡧ᳨ウࡋࡓ⤖ᯝࠊࡑࡢ᭷⏝ᛶࡀ☜ㄆࡉࢀࡓࡇ࡜࠿ࡽసᡂࡉࢀࡓࠋ ௨ୖࡢ⌮⏤࡟ࡼࡾࠊ⾜ᨻᙜᒁࡢᏳ඲ᛶホ౯᪉ἲ࡜ࡋ࡚⓶⭵ឤసᛶヨ㦂௦᭰ἲ ࣌ࣉࢳࢻ⤖ྜᛶヨ㦂ࡢ౑⏝ࢆᥦ᱌ࡍࡿࡶࡢ࡛࠶ࡿࠋ ኱㔝Ὀ㞝Ὀ㞝                      す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஬༑ᔒⰋ᫂㸦ᅜ❧་⸆ရ㣗ရ⾨⏕◊✲ᡤ ⏕ά⾨⏕໬Ꮫ㒊㸧୍㨣 ຮ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ᖹ㈡⚽᫂㸦⊂❧⾜ᨻἲே ་⸆ရ་⒪ᶵჾ⥲ྜᶵᵓ㸧∾ ᰤ஧㸦᪥ᮏච␿ẘᛶᏛ఍㸧ቑ⏣ග㍤㸦ᗙ㛗᥎⸀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఍㸧ྜྷ⏣ ⥳㸦ᅜ❧་⸆ရ㣗ရ⾨⏕◊✲ᡤ Ᏻ඲ᛶ⏕≀ヨ㦂◊✲ࢭࣥࢱ࣮ ⑓⌮㒊㸧ྜྷᮧ ຌ㸦ᗙ㛗᥎⸀㸧Ώ㒊୍ே㸦᪥ᮏ〇⸆ᕤᴗ༠఍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᳜ᮧᒎ⏕㸦ཌ⏕ປാ┬ ་⸆㣗ရᒁ ᑂᰝ⟶⌮ㄢ㸧ᑠᕝஂ⨾Ꮚ 㸦ᅜ❧་⸆ရ㣗ရ⾨⏕◊✲ᡤ Ᏻ඲ᛶ⏕≀ヨ㦂◊✲ࢭࣥࢱ࣮ ⑓⌮㒊㸧Ⳣ㔝 ⣧㸦ᅜ❧་⸆ရ㣗ရ⾨⏕◊✲ᡤ Ᏻ඲ᛶ⏕≀ヨ㦂◊✲ࢭࣥࢱ࣮ ẘᛶ㒊㸧಴ᣢ᠇㊰㸦ཌ⏕ປാ┬ ་⸆㣗ရᒁ ໬Ꮫ≀㉁Ᏻ඲ᑐ⟇ᐊ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┬ ་⸆㣗ရᒁ ໬Ꮫ≀㉁Ᏻ඲ᑐ⟇ᐊ㸧୰ᮧ㧗ᩄ㸦⊂❧⾜ᨻἲே ་⸆ရ་⒪ᶵჾ⥲ྜᶵᵓ㸧᪥⏣ ඘㸦ཌ⏕ປാ┬ ་⸆㣗ရᒁ ໬Ꮫ≀㉁Ᏻ඲ᑐ⟇ᐊ㸧ᗈ℩᫂ᙪ  㸦ᅜ❧་⸆ရ㣗ရ⾨⏕◊✲ᡤ Ᏻ඲ᛶ⏕≀ヨ㦂◊✲ࢭࣥࢱ࣮ ⥲ྜホ౯◊✲ᐊ㸧ᮏ㛫ṇ඘㸦ᅜ❧་⸆ရ㣗ရ⾨⏕◊✲ᡤ Ᏻ඲ᛶ⏕≀ヨ㦂◊✲ࢭࣥࢱ࣮ ኚ␗㑇ఏ㒊㸧ᑠᓥ ⫕㸦ᅜ❧་⸆ရ㣗ရ⾨⏕◊✲ᡤ Ᏻ඲ᛶ⏕≀ヨ㦂◊✲ࢭࣥࢱ࣮ ⸆⌮㒊᪂つヨ㦂⾲ホ౯ᐊ㸧㸸஦ົᒁ

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JaCVAM statement onDirect Peptide Reactivity Assay for Skin Sensitisation Testing
At a meeting held on 17 December 2014 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: When using the Direct Peptide Reactivity Assay (DPRA) in a regulatory context,
it is reasonable for substances that give positive results to be classified as a strong
sensitiser, i.e., a Category 1 substance under the Globally Harmonized System ofClassification and Labelling of Chemicals (GHS). It is, however, necessary to bearin mind that this assay occasionally yields false positive results for certain
substances. Conversely, it is quite possible that the DPRA will yield false negative
results for some chemicals, which means that it would be unreasonable to use thisassay as a standalone test for assessing skin sensitisation potency. We therefore
conclude that the use of the DRPA in a regulatory context requires that theassessment also take into account information from other sources.
This statement was prepared following a review of OECD TG No. 442C “In Chemico Skin
Sensitisation: Direct Peptide Reactivity Assay (DPRA)” as well as a JRC Scientific and Policy
Report “EURL ECVAM Recommendation on the Direct Peptide Reactivity Assay (DPRA) for
Skin Sensitisation Testing”. The JaCVAM Regulatory Acceptance Board acknowledges thatthe results of this review as well as of a study of materials prepared by the JaCVAM EditorialCommittee indicate that this assay is useful in a regulatory context.
Based on the above, we propose that regulatory agencies performing safety assessment of skinsensitisation potency consider using the DPRA Assay as an alternative to testing withlaboratory animals.

Yasuo Ohno
Chairperson
JaCVAM Regulatory Acceptance Board

Akiyoshi Nishikawa
Chairperson
JaCVAM Steering Committee

20 March 2015v

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

Mr. Yasuo Ohno (nominee by JaCVAM Steering Committee): Chairperson
Mr. Hideaki Hiraga (Pharmaceuticals and Medical Devices Agency)
Mr. Tsutomu Ichiki (Japan Chemical Industry Association)
Mr. Yoshiaki Ikarashi (National Institute of Health Sciences: NIHS)
Mr. Eiji Maki (Japanese Society of Immunotoxicology)
Mr. Mitsuteru Masuda (nominee by Chairperson)
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)
Ms. Midori Yoshida (NIHS)
Mr. Takemi Yoshida (Japanese Society of Toxicology)
Mr. Isao Yoshimura (nominee by Chairperson)
Mr. Kazuto Watanabe (Japan Pharmaceutical Manufacturers Association)
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. Kenji Kuramochi (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. Atsuya Takagi (Animal Management Section of the Division of Cellular andMolecular Toxicology, BSRC, NIHS)
Mr. Masaaki Tsukano (Ministry of Health, Labour and Welfare)
Mr. Nobuo Uemura (Ministry of Health, Labour and Welfare)Mr. Hajime Kojima (Section for the Evaluation of Novel Methods, Division ofPharmacology, BSRC, NIHS): Secretaryvii

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