ホ౯఍㆟ሗ࿌᭩෌ᵓ⠏ࣄࢺゅ⭷ᵝୖ⓶ࣔࢹࣝἲ RhCE ἲ 
SkinEthicTM HCE/S ࢆ⏝࠸ࡓ║่⃭ᛶヨ㦂 SkinEthicTM HCE EIT 

JaCVAM ホ౯఍㆟

ᖹᡂ 30 ᖺ㸦2018 ᖺ㸧2 ᭶ 21 ᪥

11

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⭵ච␿࢔ࣞࣝࢠ࣮Ꮫ఍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 ᪥22෌ᵓ⠏ࣄࢺゅ⭷ᵝୖ⓶ࣔࢹࣝἲ㸦Reconstructed human Cornea-like Epithelium Test Method: RhCE ἲ㸧ࡣࠊ࢘ࢧࢠࢆ⏝࠸ࡓ Draize ║่⃭ᛶヨ㦂ࡢ௦᭰ヨ㦂ἲ࡜ࡋ࡚ࠊ⿕㦂≀㉁ࡢࣄࢺゅ⭷ᵝୖ⓶ࣔࢹࣝ⤌⧊࡟ᑐࡍࡿ⣽⬊ẘᛶࢆᣦᶆ࡟⏝࠸ࠊࡑࡢ≀㉁ࡢ║่⃭ᛶࢆホ౯ࡍࡿヨ㦂ἲ࡛࠶ࡿࠋOECD TG492 ࡜ࡋ࡚࣎ࢺ࣒࢔ࢵࣉ᪉ᘧ࡛ United Nations Globally Harmonized System of Classification and Labelling of Chemicals㸦UNGHS㸧༊ศእ≀㉁ࢆ᳨ฟ࡛ࡁࡿ RhCE ἲࡢ୍ࡘ࡜ࡋ࡚ࠊEpiOcularTM ࡀ᥇ᢥࡉࢀ࡚࠸ࡿࠋࡇࡢᗘࠊSkinEthicTM
ࣄࢺゅ⭷ᵝୖ⓶ࣔࢹࣝ㸦SkinEthicTM HCE/S㸧ࢆ⏝࠸ࡓ║่⃭ᛶヨ㦂(SkinEthicTM HCE EIT)ࡀ RhCE ἲࡢ୍ࡘ࡜ࡋ࡚ࠊᨵゞ TG 4921)࡟᳨ド῭ࡳᶆ‽ヨ㦂ἲ࡜ࡋ࡚㏣ຍࡉࢀࡓࠋSkinEthicTM HCE/S ࢆ⏝࠸ࡿ RhCE
ἲࡣࠊEURL ECVAM(European Union Reference Laboratory for Alternatives to Animal Testing)࡜
CE(Cosmetics Europe)ࡢඹྠࣂࣜࢹ࣮ࢩࣙࣥ◊✲ 2)ࡀ⾜ࢃࢀࠊࣉࣟࢺࢥࣝࡢ᭱㐺໬ࠊ3 ᪋タࣂࣜࢹ࣮ࢩࣙ
ࣥ◊✲࠾ࡼࡧ ESAC㸦EURL ECVAM Scientific Advisory Committee㸧ࡢ➨୕⪅ホ౯ࢆ⤒࡚ࠊ2017 ᖺ 10 ᭶࡟ᨵゞ TG492 ࡟㏣グࡉࢀࡓࠋJaCVAM ホ౯఍㆟ࡣࠊ║่⃭ᛶヨ㦂㈨ᩱ⦅⧩ጤဨ఍࡟ࡼࡾసᡂࡉࢀࡓࠕ෌
ᵓ⠏ࣄࢺゅ⭷ᵝୖ⓶ࣔࢹࣝἲ(RhCE ἲ)Skin EthicTM HCE/S ࢆ⏝࠸ࡓ║่⃭ᛶヨ㦂(Skin EthicTM HCE EIT)
ホ౯ሗ࿌᭩ࠖ3)ࢆ⏝࠸࡚ࠊᮏヨ㦂ἲࡢጇᙜᛶ࡟ࡘ࠸᳨࡚ウࡋࡓࠋ㸯㸬ヨ㦂ἲࡢᐃ⩏ྡ⛠㸸 ෌ᵓ⠏ࣄࢺゅ⭷ᵝୖ⓶ࣔࢹࣝἲ㸦Reconstructed human Cornea-like Epithelium Test Method: RhCE
ἲ SkinEthicTM ࣄࢺゅ⭷ᵝୖ⓶ࣔࢹࣝࢆ⏝࠸ࡓ║่⃭ᛶヨ㦂㸧௦᭰ࡍࡿᑐ㇟ẘᛶヨ㦂㸸Draize ║่⃭ᛶヨ㦂ἲヨ㦂ἲࡢᴫ␎㸸 RhCE ἲࡣࠊ෌ᵓ⠏ࣄࢺゅ⭷ᵝୖ⓶ࣔࢹࣝࢆ⏝࠸ࡓ║่⃭ᛶヨ㦂࡛࠶ࡿࠋRhCE ἲࡢࡦ࡜ࡘ࡛࠶ࡿ SkinEthicTM HCE EIT ࡛ࡣࠊ⿕㦂≀㉁ࡀᾮయࡢሙྜࡣ⣙ 30 ศ㛫ࠊᅛయࡢሙྜࡣ⣙ 4᫬㛫⿕㦂≀㉁ࢆ SkinEthicTM HCE/S ࡟᭚㟢ࡋࡓᚋࠊMTT ࡢ㑏ඖ㔞ࢆࡶ࡜࡟ࡋࡓ⣽⬊⏕Ꮡ⋡ࢆᐃࡋࠊ║่⃭ᛶホ౯ࡢᣦᶆ࡜ࡋ࡚⏝࠸ࡿࠋࡇࢀࡣࠊMTT ࡀ࣑ࢺࢥࣥࢻࣜ࢔ࡢ⬺Ỉ⣲㓝⣲ࡢᇶ㉁࡜࡞ࡿᛶ㉁ࢆ฼⏝ࡋࠊ⣽⬊ෆ࡟ྲྀࡾ㎸ࡲࢀࡓ MTT ࡀ⬺Ỉ⣲㓝⣲࡟ࡼࡾ㑏ඖࡉࢀࠊ⏕ᡂࡉࢀࡓ࣐࣍ࣝࢨࣥ㔞㸦㟷Ⰽ㸧ࡀ⏕Ꮡ⣽⬊ᩘ࡟ẚ౛ࡍࡿࡇ࡜࡟ᇶ࡙࠸࡚࠸ࡿ㸦MTT 㑏ඖἲ㸧ࠋ⿕㦂≀㉁ࡀᾮయࡢሙྜࠊ⣽⬊⏕Ꮡ⋡ࡀ㝜ᛶᑐ↷࡜ẚ㍑ࡋ࡚ 60㸣ࢆ㉸࠼ࡿ࡜ࠊࡲࡓࠊ⿕㦂≀㉁ࡀᅛయ
ࡢሙྜࡣ⣽⬊⏕Ꮡ⋡ࡀ 50㸣ࢆ㉸࠼ࡿ࡜ UN GHS ศ㢮࡟࠾࠸࡚༊ศእ࡛࠶ࡿ࡜ุᐃࡍࡿࠋࡇࢀࡽ࢝ࢵࢺ࢜ࣇ್௨ୗࡢሙྜࡣࠊᮏヨ㦂ἲ࡛ࡣഇ㝧ᛶࡀ⏕ࡌࡿࡇ࡜ࠊ༊ศ 1 ࡜༊ศ 2 ࢆ㆑ู࡛ࡁ࡞࠸ࡇ࡜࠿ࡽࠊ௚ࡢヨ㦂ἲ࡟ࡼࡿ㏣ຍヨ㦂ࡀᚲせ࡟࡞ࡿࠋ  㸰㸬ホ౯࡟⏝࠸ࡓ㈨ᩱ࠾ࡼࡧホ౯ෆᐜࡢ⛉Ꮫⓗጇᙜᛶ║࡟␗≀ࡀධࡗࡓሙྜࠊ║ࡢ่⃭ࡣࠊ⚄⤒➼ࡢ≉ᐃࡢཷᐜయ࡟స⏝ࡍࡿሙྜࢆ㝖ࡁࠊ୍⯡࡟ゅ⭷ࡸ⤖⭷ࡢ⣽⬊യᐖ࠿ࡽጞࡲࡿࠋDraize ἲ࡟࠾ࡅࡿ║่⃭ᛶࡢ⛬ᗘࡢุᐃࡣࠊ୺࡟ゅ⭷ࡢึᮇയᐖࡢ⛬ᗘ࡟኱ࡁࡃᙳ㡪ࡉࢀࠊࡑࢀࡣゅ⭷ୖ⓶⣽⬊ࡢ⣽⬊Ṛࡢ⛬ᗘ࡜┦㛵㛵ಀ࡟࠶ࡿࠋᮏヨ㦂ἲࡣࠊࣄࢺࡢゅ⭷ୖ⓶࡟㢮ఝࡋࡓᵓ㐀ࢆ᭷ࡍࡿ RhCE㸦SkinEthicTM HCE/S㸧ࢆ⏝࠸࡚ࠊ⿕㦂≀㉁ࡢ⣽⬊ẘᛶࢆᣦᶆ࡜ࡋ࡚║่⃭ᛶࢆホ౯ࡍࡿヨ㦂ἲ࡛࠶ࡿࠋࡇࢀࡽࡢࡇ࡜࠿ࡽࠊᮏヨ㦂ἲࡣ࢘ࢧࢠࢆ⏝࠸ࡿ║่⃭ᛶヨ㦂ࡢ௦᭰ἲ࡜ࡋ
࡚⛉Ꮫⓗጇᙜᛶࡀ࠶ࡿࠋ

33

SkinEthicTM HCE EIT ࡟ࡘ࠸࡚ࡣࠊEURL ECVAM ࡜ CE ࡢඹྠࣂࣜࢹ࣮ࢩࣙࣥ◊✲ 2)ࡀ⾜ࢃࢀࡓࠋࡑࡢᚋࣉࣟࢺࢥࣝࡢ᭱㐺໬ࢆ⾜ࡗ࡚ࠊUN GHS ༊ศ≀㉁࣭༊ศእ≀㉁ࡸᅛయ࣭ᾮయࡢࣂࣛࣥࢫࢆ⪃៖ࡋ࡚120 ≀㉁࡟ࡘ࠸࡚ 3 ᪋タ࡛ࣂࣜࢹ࣮ࢩࣙࣥ◊✲ࡀ⾜ࢃࢀࡓࠋ⿕㦂≀㉁࡟ࡣࠊMTT 㑏ඖ≀㉁ࡸ࣐࣍ࣝࢨࣥ
࡜ྠࡌࡼ࠺࡞Ἴ㛗ࢆࡶࡘ╔Ⰽ≀㉁ࡶྵࡵࡽࢀࡓࠋࡲࡓࠊࣂࣜࢹ࣮ࢩࣙࣥ◊✲࡜ࡣู࡟ࠊ࣮ࣜࢻࣛ࣎࡟࠾࠸࡚ 80 ≀㉁࡟ࡘ࠸࡚㏣ຍヨ㦂ࡀ⾜ࢃࢀࡓ 4,5)ࠋ
᪋タෆ෌⌧ᛶࠊ᪋タ㛫෌⌧ᛶ࠾ࡼࡧヨ㦂ἲࡢṇ☜ᛶ࡟ࡘ࠸࡚ࡶ EURL ECVAM
SkinEthicTM HCE EIT ࡣࠊࣂࣜࢹ࣮ࢩࣙࣥ㐠Ⴀጤဨ఍ࡢᐃࡵࡓᇶ‽ࢆ‶ࡓࡋࡓࠋࡉࡽ࡟ ESAC ࡢ➨୕⪅ホ౯ 6)ࢆ⤒࡚ࠊUN GHS ༊ศእ≀㉁ࢆ᳨ฟࡍࡿ᪉ἲ࡜ࡋ࡚ 2017 ᖺ 10 ᭶࡟ᨵゞ TG492 ࡟㏣グࡉࢀࡓࠋJaCVAM ║่⃭ᛶヨ㦂㈨ᩱ
⦅⧩ጤဨ఍ࡣࠊࡇࢀࡽࡢ㈨ᩱࢆ⏝࠸࡚ᮏヨ㦂ἲࢆホ౯ࡋ࡚࠾ࡾࠊ⛉Ꮫⓗ࡟ጇᙜ࡞ホ౯࡛࠶ࡿ࡜⪃࠼ࡿࠋ㸱㸬ᮏヨ㦂ἲࡢ᭷⏝ᛶ࡜㐺⏝㝈⏺
RhCE ἲ࡟⏝࠸ࡿ SkinEthicTM HCE/S ࡣᕷ㈍ࡉࢀ࡚࠾ࡾࠊࡇࢀ௨እࡣ≉Ṧ࡞ᶵᮦࡸヨ⸆ࢆᚲせ࡜ࡏࡎࠊᡭᢏࡶ」㞧࡛ࡣ࡞࠸ࡇ࡜࠿ࡽᢏ⾡⛣㌿ᛶࡣ㧗࠸࡜ุ᩿࡛ࡁࡿࠋణࡋࠊධᡭࡋࡓ SkinEthicTM HCE/S ࡀရ㉁ᇶ‽ࡢチᐜ⠊ᅖ࡟࠶ࡾࠊ࠿ࡘᐇ᪋ࡍࡿヨ㦂᪋タࡢᢏ⾡⩦ᚓࡀ࢞࢖ࢻࣛ࢖ࣥࡢ⇍㐩ᗘ☜ㄆ≀㉁࡛☜࠿ࡵࡽࢀ࡚࠸ࡿᚲせࡀ࠶ࡿࠋUN GHS ༊ศእ≀㉁ࢆ᳨ฟࡍࡿ᪉ἲ࡜ࡋ࡚ࡢಙ㢗ᛶࢆㄪ࡭ࡿࡓࡵࠊ᪋タෆ෌⌧ᛶ࠾ࡼࡧ᪋タ㛫෌⌧ᛶࢆ᳨ウࡍࡿࣂࣜࢹ࣮ࢩࣙࣥ◊✲ࡀ⾜ࢃࢀ࡚࠸ࡿࠋࣂࣜࢹ࣮ࢩࣙࣥ◊✲࡟࠾࠸࡚ࠊྛ᪋タࡢ᪋タෆ෌⌧ᛶࡣࠊᾮయ⏝ࣉࣟࢺࢥ࡛ࣝ 88.3-95.0㸣ࠊᅛయ⏝ࣉࣟࢺࢥ࡛ࣝ 95.0-96.7㸣࡛࠶ࡾࠊEURL ECVAM ࣂࣜࢹ࣮ࢩࣙࣥ㐠Ⴀጤဨ఍ࡀᐃࡵࡓᇶ‽㸦85㸣௨ୖ㸧ࢆ‶ࡓࡋ࡚࠸ࡓ㸰)ࠋࡲࡓࠊ᪋タ㛫෌⌧ᛶ࡟㛵ࡋ࡚ࡣࠊᮏヨ㦂࡛ᚓࡽࢀࡓ⣽⬊⏕Ꮡ⋡㸦」ᩘᅇヨ㦂㸧ࡢᖹᆒ್ࢆࡶ࡜࡟ UN GHS ศ㢮ุᐃࢆ᪋タࡈ࡜࡟⾜࠸ࠊᾮయ⏝ࣉࣟࢺࢥ࡛ࣝ 93.3㸣ࠊᅛయ⏝ࣉࣟࢺࢥ࡛ࣝ 96.7㸣ࠊ඲య࡛ࡣ 95.0㸣࡜࡞ࡾࠊࣂࣜࢹ࣮ࢩࣙࣥ㐠Ⴀጤဨ఍ࡀᐃࡵࡓᇶ‽㸦80㸣௨ୖ㸧ࢆ‶ࡓࡋ࡚࠸ࡓ 3)ࠋࡉࡽ࡟ࠊࣂࣜࢹ࣮ࢩࣙࣥ◊✲࡛ᚓࡽࢀࡓࢹ࣮ࢱ࡟ࡼࡿṇ☜ᛶࡢホ౯࡛ࡣࠊᾮయࣉࣟࢺࢥ࡛ࣝឤᗘ 98.3㸣ࠊ≉␗ᗘ 69.4㸣࠾ࡼࡧṇ☜ᗘ 84.8㸣ࠊᅛయ⏝ࣉࣟࢺࢥࣝ
࡛ឤᗘ 92.2㸣ࠊ≉␗ᗘ 76.6㸣࠾ࡼࡧṇ☜ᗘ 84.4㸣࡜࡞ࡾࣂࣜࢹ࣮ࢩࣙࣥ㐠Ⴀጤဨ఍ࡀᐃࡵࡓᇶ‽㸦ឤᗘ
90㸣௨ୖࠊ≉␗ᗘ 60㸣௨ୖࠊṇ☜ᗘ 75㸣௨ୖ㸧ࢆ‶ࡓࡋ࡚࠸ࡓ 3)ࠋ

44⾲㸬SkinEthicTM HCE EIT ࡢṇ☜ᛶ≀㉁ᩘ

ឤᗘ(%)≉␗ᗘ(%)

ṇ☜ᗘ(%)

ᾮయ

60

98.3

69.484.8

ᅛయ

60

92.2

76.6

84.4

௦᭰ἲ࡜ࡋ࡚ࡢ
ཷࡅධࢀᇶ‽ 1)- 90%60%

75%║่⃭ᛶ௦᭰ἲ㈨ᩱ⦅⧩ጤဨ఍ࡢሗ࿌᭩㸦⾲㸯㸧ࡼࡾᘬ⏝ 3)ణࡋࠊ⣽⬊⏕Ꮡ⋡ࡢ⟬ฟ࡟ MTT 㑏ඖἲࢆ⏝࠸ࡿ௚ࡢ௦᭰ἲ࡜ྠᵝ࡟ࠊ⿕㦂≀㉁ࡀ MTT ࢆ㑏ඖࡍࡿ≀㉁ࡢሙྜࠊ࠶ࡿ࠸ࡣ࣐࣍ࣝࢨࣥ࡜ྠࡌࡼ࠺࡞Ἴ㛗㸦570 nm ㏆㎶㸧࡟྾཰ࢆᣢࡘ╔Ⰽ≀㉁ࡢሙྜ࡟ࡣࠊ྾
ගᗘ⿵ṇࢆ⾜࠺ᚲせࡀ࠶ࡿࠋࡑࡢᡭ㡰࡟ࡘ࠸࡚ࡣࠊᨵゞ TG492 ࡢᮏᩥࡢㄝ᫂࠾ࡼࡧ ANNEX IV ࡢヨ㦂ἲࢆཧ↷ࡍࡿᚲせࡀ࠶ࡿࠋࡲࡓࠊᮏヨ㦂ἲࢆ㐺⏝ࡍࡿ࡟ࡣࠊヨ㦂ἲࡢᛶ㉁࡜ṇ☜ᛶࡢ☜ಖࢆ⪃៖ࡋ࡚௨ୗࡢไ㝈ࡀタࡅࡽࢀࡿࠋ1) ࣂࣜࢹ࣮ࢩࣙࣥ◊✲࡟࠾࠸࡚⿕㦂≀㉁࡟ྵࡵࡽࢀ࡞࠿ࡗࡓẼయ㸦࢞ࢫ㸧࠾ࡼࡧ࢚࢔ࢰ࣮ࣝࡣ㐺⏝≀㉁࠿ࡽ㝖እࡉࢀࡿࠋ2) UN GHS ༊ศࡢ༊ศ 1 ≀㉁࡜༊ศ 2㸦2A/2B㸧≀㉁ࡢ㆑ู࡟ࡣ⏝࠸ࡿࡇ࡜ࡣ࡛ࡁ࡞࠸ࠋ
௨ୖࡢⅬ࠿ࡽࠊTG492 ࡟‽ᣐࡋ࡚ᐇ᪋ࡋࡓሙྜࠊ࣎ࢺ࣒࢔ࢵࣉ᪉ᘧ࡟࠾࠸࡚ UN GHS ༊ศእ≀㉁ࢆ᳨
ฟࡍࡿ᪉ἲ࡜ࡋ࡚᭷⏝࡛࠶ࡿ࡜⪃࠼ࡿࠋ㸲㸬┠ⓗ࡜ࡍࡿ≀㉁ཪࡣ〇ရࡢẘᛶࢆホ౯ࡍࡿヨ㦂ἲ࡜ࡋ࡚ࡢࠊ♫఍ⓗཷࡅධࢀᛶ࠾ࡼࡧ⾜ᨻୖࡢ฼⏝ࡢྍ⬟ᛶ ♫఍ⓗཷࡅධࢀᛶ㸸ᮏヨ㦂ἲࡣ RhCE ࡟ᑐࡍࡿ໬Ꮫ≀㉁ࡢ⣽⬊ẘᛶࢆᣦᶆ࡟⏝࠸࡚║่⃭ᛶࢆホ౯ࡍࡿヨ㦂ἲ࡛࠶ࡾࠊ⏕ࡁࡓື≀ࢆ⏝࠸࡞࠸࡜࠸࠺Ⅼ࡛ࠊ3Rs ࡢ⢭⚄࡟ྜ⮴ࡋ࡚࠸ࡿࠋࡲࡓࠊSkinEthicTM HCE/S ࡢධᡭࡣᐜ࡛᫆ࠊ▷᫬㛫࡛Ᏻ౯࡟ᐇ᪋࡛ࡁࠊ≉Ṧ࡞ᶵᮦࡸヨ⸆ࢆᚲせ࡜ࡏࡎࠊᚲせ࡞ᡭᢏࡶ」㞧࡞ࡶࡢ࡛࡞࠸ࠋࡋࡓࡀࡗ࡚ࠊධᡭࡋࡓ SkinEthicTM HCE/S ࡀရ㉁ᇶ‽ࡢチᐜ⠊ᅖ࡟࠶ࡾࠊ࠿ࡘᐇ᪋ࡍࡿヨ㦂᪋タࡢᢏ⾡⩦ᚓࡀ࢞࢖ࢻࣛ࢖ࣥࡢ⇍㐩ᗘ☜ㄆ≀㉁࡛☜࠿ࡵࡽࢀ࡚࠸ࢀࡤࠊᇶᮏⓗ࡞⣽⬊ᇵ㣴ࡢᢏ⾡࡜タഛࢆ᭷ࡍࡿ᪋タ࡛࠶ࢀࡤᐇ᪋ྍ⬟࡛࠶ࡾࠊᢏ⾡⛣㌿ᛶࡣ㧗࠸ࠋ௨ୖࡼࡾࠊᮏヨ㦂ἲࡢ♫఍ⓗཷࡅධࢀᛶࡣ㧗࠸ࠋ
55⾜ᨻୖࡢ฼⏝ᛶ㸸ᮏヨ㦂ἲࡣࠊ໬Ꮫ≀㉁࡟ࡼࡿ║่⃭ᛶࢆホ౯࡛ࡁࠊ࣎ࢺ࣒࢔ࢵࣉ᪉ᘧ࡟࠾࠸࡚ UN GHS ༊ศእ≀㉁ࢆ
᳨ฟࡍࡿ᪉ἲ࡜ࡋ࡚ࠊ⾜ᨻⓗ฼⏝ࡀྍ⬟࡛࠶ࡿ࡜⪃࠼ࡿࠋ
࡞࠾ࠊRhCE ἲ࡟ EpiOcularTM ࡲࡓࡣ SkinEthicTM HCE/S ௨እࢆ⏝࠸ࡿሙྜ࡟ࡣࠊOECD TG492 ࡢᛶ⬟ᶆ‽࡟グ㍕ࡉࢀࡓ≀㉁ࢆ⏝࠸࡚ࠊࡑࡢጇᙜᛶࢆ☜ㄆࡋ࡚࠾ࡃᚲせࡀ࠶ࡿ 1)ࠋ

ཧ⪃ᩥ⊩1) OECD (2017) Guideline for the testing of chemicals. 492, Reconstructed human Cornea-like Epithelium(RhCE) test method for identifying chemicals not requiring classification and labelling for eye irritation orserious eye damage.
2) EURL ECVAM-CE (2014) Prospective validation study of Reconstructed Human Tissue-based test methods
for identifying chemical not requiring classification for serious eye damage/eye irritation – Validation StudyReport.
3) JaCVAM ║่⃭ᛶ௦᭰ἲ㈨ᩱ⦅⧩ጤဨ఍㸸ホ౯ሗ࿌᭩ ෌ᵓ⠏ࣄࢺゅ⭷ᵝୖ⓶ࣔࢹࣝἲ(RhCEἲ)SkinEthicTM HCE/Sࢆ⏝࠸ࡓ║่⃭ᛶヨ㦂 (SkinEthicTM HCE EIT)㸦ᖹᡂ29ᖺ 2017ᖺ 12᭶4᪥㸧4) Alépée N., et al. (2016) Multi-laboratory validation of SkinEthic HCE test method for testing serious eyedamage/eye irritation using liquid chemicals. Toxicol In Vitro 31, 43-53.
5) Alépée N., et al. (2016) Multi-laboratory evaluation of SkinEthic HCE test method for testing serious eye
damage/eye irritation using solid chemicals and overall performance of the test method with regard to solidand liquid chemicals testing. Toxicol In Vitro 34, 55-70.
6) ESAC (2016) ESAC Opinion on the SkinEthicTM Human Corneal Epithelium (HCE) Eye Irritation Test (EIT).
ESAC Opinion No. 2016-02 of 24 June 2016.

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