᪂つヨ㦂ἲᥦ᱌᭩             ᖹᡂ 29 ᖺ 10 ᭶ 1 ᪥                                 No. 2017-02



In vitro⭷ࣂࣜ࢔ヨ㦂ࢆ⏝࠸ࡓ⓶⭵⭉㣗ᛶヨ㦂௦᭰ἲ࡟㛵ࡍࡿᥦ᱌ ᖹᡂ 29 ᖺ 7 ᭶ 25 ᪥࡟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 In vitro ⭷ࣂࣜ࢔ヨ㦂ἲ࡜ࡋ࡚ၟᴗⓗ࡟㈍኎ࡉࢀ࡚࠸ࡿヨ㦂ἲ࡜ࡋ࡚ Corrositex®ἲࡀ࠶ࡿࠋᮏヨ㦂ἲෆࡢ໬Ꮫ≀㉁᳨▱ࢩࢫࢸ࣒㸦Chemical Detection System㸸CDS㸧ࡢ㐺⏝ྍ⬟≀㉁࡟ไ⣙ࡀ࠶ࡾࠊഇ㝜ᛶࡀከ࠸ࡇ࡜࠿ࡽࠊከᵝ࡞≀㉁ࢆࢫࢡ࣮ࣜࢽࣥࢢホ౯ࡍࡿ┠ⓗ࡟ࡣ㐺ࡋ࡚࠸࡞࠸࡜⪃࠼ࡽࢀࡿࠋࡓࡔࡋࠊᮏヨ㦂ἲ࡟ࡼࡗ࡚㝧ᛶ࡜ุᐃࡉࢀࡓࡶࡢࢆ㝧ᛶ≀㉁࡜ࡋ࡚㆑ูࡍࡿࡇ࡜࡟㝈ᐃࡍࢀࡤࠊ฼⏝ྍ⬟࡜ุ᩿ࡍࡿࠋCorrositex®௨እࡢ in vitro ⭷ࣂࣜ࢔ヨ㦂ἲ࡟ࡘ࠸࡚ࡣ▱ࡽࢀ࡚࠸࡞࠸ࡀࠊ㛤Ⓨࡉࢀࡓሙྜ࡟ࡣ༑ศ࡞ࣂࣜࢹ࣮ࢩࣙࣥ⤖ᯝ࡟ᇶ࡙࠸࡚ࠊࡑࡢ⾜ᨻⓗ฼⏝ᛶࡢホ౯ࢆ⾜࠺࡭ࡁ࡛࠶ࡿࠋࡇࡢᥦ᱌᭩ࡣࠊOrganisation for Economic Co-operation and Development (OECD) Test Guideline(TG) 435, In Vitro Membrane Barrier Test Method for Skin Corrosionࢆࡶ࡜࡟ࠊ⓶⭵⭉㣗ᛶ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࡜ࡋ࡚ In vitro ⭷ࣂࣜ࢔ヨ㦂ࢆ⏝࠸ࡓ⓶⭵⭉㣗ᛶヨ㦂௦᭰ἲࡢ౑⏝ࢆᥦ᱌ࡍࡿࡶࡢ࡛࠶ࡿࠋ ኱㔝Ὀ㞝㔝Ὀ㞝                      すᕝ⛅ె
JaCVAM ホ౯఍㆟ ㆟㛗               JaCVAM 㐠Ⴀጤဨ఍ ጤဨ㛗i

JaCVAM ホ౯఍㆟኱ 㔝 Ὀ 㞝 㸦බ┈㈈ᅋἲே ᮌཎグᛕᶓ὾⏕࿨⛉Ꮫ᣺⯆㈈ᅋ㸧㸸ᗙ㛗㣤 ሯ ᑦ ᩥ 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㸧஭ ୖ ᬛ ᙲ 㸦᪥ᮏච␿ẘᛶᏛ఍㸧௒ ஭ ᩍ Ᏻ 㸦᪥ᮏື≀ᐇ㦂௦᭰ἲᏛ఍㸧ᒾ℩⿱⨾Ꮚ 㸦᪥ᮏ〇⸆ᕤᴗ༠఍㸧⠛ ⏣ ࿴ ಇ 㸦⊂❧⾜ᨻἲே ་⸆ရ་⒪ᶵჾ⥲ྜᶵᵓ㸧ᮡᒣ┿⌮Ꮚ 㸦᪥ᮏ໬⢝ရᕤᴗ㐃ྜ఍㸧௰ ஭ ಇ ྖ 㸦᪥ᮏ໬Ꮫᕤᴗ༠఍㸧୰ᮧࡿࡾࡇ 㸦⊂❧⾜ᨻἲே 〇ရホ౯ᢏ⾡ᇶ┙ᶵᵓ㸧す ᕝ ⛅ ె 㸦ᅜ❧་⸆ရ㣗ရ⾨⏕◊✲ᡤ Ᏻ඲ᛶ⏕≀ヨ㦂◊✲ࢭࣥࢱ࣮㸧἟ ⃝  ⪽ 㸦᪥ᮏẘᛶᏛ఍㸧㔝 ཱྀ ┿ ᕼ 㸦⊂❧⾜ᨻἲே ་⸆ရ་⒪ᶵჾ⥲ྜᶵᵓ㸧**᳃ ⏣  ೺ 㸦᪥ᮏ⎔ቃኚ␗ཎᏛ఍㸧ᶓ 㛵 ༤ 㞝 㸦᪥ᮏ⓶⭵࢔ࣞࣝࢠ࣮࣭᥋ゐ⓶⭵⅖Ꮫ఍㸧                ௵ᮇ㸸ᖹᡂ 28 ᖺ 4 ᭶ 1 ᪥㹼ᖹᡂ 30 ᖺ 3 ᭶ 31 ᪥*㸸ᖹᡂ 28 ᖺ 4 ᭶ 1 ᪥㹼ᖹᡂ 29 ᖺ 3 ᭶ 31 ᪥**㸸ᖹᡂ 29 ᖺ 4 ᭶ 1 ᪥㹼ᖹᡂ 30 ᖺ 3 ᭶ 31 ᪥

                 
ii

JaCVAM 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኱ ཎ  ᣅ㸦ཌ⏕ປാ┬ ་⸆࣭⏕ά⾨⏕ᒁ ་⸆ရᑂᰝ⟶⌮ㄢ㸧ᑠᕝஂ⨾Ꮚ㸦ᅜ❧་⸆ရ㣗ရ⾨⏕◊✲ᡤ Ᏻ඲ᛶ⏕≀ヨ㦂◊✲ࢭࣥࢱ࣮ ⑓⌮㒊㸧ຍ ⸨  ⠜㸦ᅜ❧ឤᰁ⑕◊✲ᡤ㸧ㅋ ⏣ Ὀ ᡂ㸦ᅜ❧་⸆ရ㣗ရ⾨⏕◊✲ᡤ Ᏻ඲ᛶ⏕≀ヨ㦂◊✲ࢭࣥࢱ࣮ ⸆⌮㒊㸧ᑠụ⣫୍㑻㸦ཌ⏕ປാ┬ ་⸆࣭⏕ά⾨⏕ᒁ ་⸆ရᑂᰝ⟶⌮ㄢ ໬Ꮫ≀㉁Ᏻ඲ᑐ⟇ᐊ㸧⠛ ⏣ ࿴ ಇ㸦⊂❧⾜ᨻἲே ་⸆ရ་⒪ᶵჾ⥲ྜᶵᵓ㸧㧗 ᮌ ⠜ ஓ㸦ᅜ❧་⸆ရ㣗ရ⾨⏕◊✲ᡤ Ᏻ඲ᛶ⏕≀ヨ㦂◊✲ࢭࣥࢱ࣮ ẘᛶ㒊 ື≀⟶⌮ᐊ㸧᮰ 㔝 ṇ ᫂㸦ཌ⏕ປാ┬ ་⸆࣭⏕ά⾨⏕ᒁ ་⸆ရᑂᰝ⟶⌮ㄢ ໬Ꮫ≀㉁Ᏻ඲ᑐ⟇ᐊ㸧ᖹ ᯘ ᐜ Ꮚ 㸦ᅜ❧་⸆ရ㣗ရ⾨⏕◊✲ᡤ Ᏻ඲ᛶ⏕≀ヨ㦂◊✲ࢭࣥࢱ࣮ ẘᛶ㒊㸧ᗈ ℩ ᫂ ᙪ㸦ᅜ❧་⸆ရ㣗ရ⾨⏕◊✲ᡤ Ᏻ඲ᛶ⏕≀ヨ㦂◊✲ࢭࣥࢱ࣮ Ᏻ඲ᛶண ホ౯㒊㸧ᘅ ⏣ ග ᜨ㸦⊂❧⾜ᨻἲே ་⸆ရ་⒪ᶵჾ⥲ྜᶵᵓ㸧ῲ ᒸ  Ꮫ㸦ཌ⏕ປാ┬ ་⸆࣭⏕ά⾨⏕ᒁ ་⸆ရᑂᰝ⟶⌮ㄢ ໬Ꮫ≀㉁Ᏻ඲ᑐ⟇ᐊ㸧ᮏ 㛫 ṇ ඘ 㸦ᅜ❧་⸆ရ㣗ရ⾨⏕◊✲ᡤ Ᏻ඲ᛶ⏕≀ヨ㦂◊✲ࢭࣥࢱ࣮ ኚ␗㑇ఏ㒊㸧Ώ 㑔 ఙ ୍㸦ཌ⏕ປാ┬ ་⸆࣭⏕ά⾨⏕ᒁ ་⸆ရᑂᰝ⟶⌮ㄢ㸧ᑠ ᓥ  ⫕ 㸦ᅜ❧་⸆ရ㣗ရ⾨⏕◊✲ᡤ Ᏻ඲ᛶ⏕≀ヨ㦂◊✲ࢭࣥࢱ࣮ Ᏻ඲ᛶணホ౯㒊➨஧ᐊ㸧㸸஦ົᒁiii

JaCVAM Statement on theIn Vitro Membrane Barrier Test Method for Skin Corrosion
At a meeting held on 25 July 2017 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: Corrositex® is a commercially available in vitro membrane barrier test method.
We do not consider this test method to be suitable for predicting the skin corrosion
potential of test chemicals due to a significant number of false negative test results
and the limited applicability domain of the Chemical Detection System (CDS).
Since a positive result from this test method can, however, be consideredsufficient for predicting a test chemical to cause skin corrosion, this test could be
useful when used within that limitation. We do not know of any other in vitro
membrane barrier model, and if a new model is developed, its suitability for use ina regulatory context should be evaluated based on the results of a validation study.
This statement was prepared following a review of the Organisation for Economic
Co-operation and Development (OECD) Test Guideline (TG) 435 In Vitro Membrane Barrier
test method for skin corrosion together with other materials prepared by the Skin Corrosion
Testing JaCVAM Editorial Committee to acknowledge that the results of a review and study
by the JaCVAM Regulatory Acceptance Board have confirmed the limited usefulness of thisassay.
Based on the above, we propose the In Vitro Membrane Barrier test method as a useful means
for assessing skin corrosion potential during safety assessments by regulatory agencies.

Yasuoasuo Ohno
Chairperson
h i
JaCVAM Regulatory Acceptance BoardAkiyoshi Nishikawa
Chairperson
JaCVAM Steering Committee

October 1, 2017v

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 Regulatory
Acceptance Board:

Mr. Yasuo Ohno (Kihara Memorial Yokohama Foundation for the Advancement ofLife Sciences) : Chairperson
Mr. Naofumi Iizuka (Pharmaceuticals and Medical Devices Agency)*
Mr. Yoshiaki Ikarashi (National Institute of Health Sciences: NIHS)
Mr. Noriyasu Imai (Japanese Society for Alternatives to Animal Experiments)
Mr. Tomoaki Inoue (Japanese Society of Immunotoxicology)
Mr. Yuji Ishii (Biological Safety Research Center: BSRC, NIHS)
Ms. Yumiko Iwase (Japan Pharmaceutical Manufacturers Association)
Mr. Takeshi Morita (Japanese Environmental Mutagen Society)
Mr. Shunji Nakai (Japan Chemical Industry Association)
Ms. Ruriko Nakamura (National Institute of Technology and Evaluation)
Mr. Akiyoshi Nishikawa (BSRC, NIHS)
Ms. Maki Noguchi (Pharmaceuticals and Medical Devices Agency)**
Mr. Satoshi Numazawa (Japanese Society of Toxicology)
Mr. Kazutoshi Shinoda (Pharmaceuticals and Medical Devices Agency)
Ms. Mariko Sugiyama (Japan Cosmetic Industry Association)
Mr. Hiroo Yokozeki (Japanese Society for Dermatoallergology and Contact Dermatitis)
Term: From 1st April 2016 to 31st March 2018*: From 1st April 2016 to 31st March 2017**: From 1st April 2017 to 31st March 2018vi

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. Manabu Fuchioka (Ministry of Health, Labour and Welfare)
Ms. Yoko Hirabayashi (Division of Toxicology, BSRC, NIHS)
Mr. Akihiko Hirose (Division of Risk Assessment, BSRC, NIHS)
Ms. Mitsue Hirota (Pharmaceutical & Medical Devices Agency)
Mr. Masamitsu Honma (Division of Genetics and Mutagenesis, BSRC, NIHS)
Mr. Yasunari Kanda (Division of Pharmacology, BSRC, NIHS)
Mr. Atsushi Kato (National Institute of Infectious Diseases)
Mr. Kouichirou Koike (Ministry of Health, Labour and Welfare)
Ms. Kumiko Ogawa (Division of Pathology, BSRC, NIHS)
Mr. Taku Oohara (Ministry of Health, Labour and Welfare)
Mr. Kazutoshi Shinoda (Pharmaceuticals and Medical Devices Agency)
Mr. Atsuya Takagi (Animal Management Section of the Division of Toxicology, BSRC,NIHS)
Mr. Masaaki Tsukano (Ministry of Health, Labour and Welfare)
Mr. Shinichi Watanabe (Ministry of Health, Labour and Welfare)Mr. Hajime Kojima (Division of Risk Assessment, BSRC, NIHS): Secretaryvii