║่⃭ᛶヨ㦂௦᭰ἲࡢホ౯఍㆟ሗ࿌᭩෌ᵓ⠏ࣄࢺゅ⭷ᵝୖ⓶ࣔࢹࣝἲ(Reconstructed Human Cornea-like Epithelium Test Method: RhCE ἲ)

JaCVAM ホ౯఍㆟

ᖹᡂ 28 ᖺ㸦2016 ᖺ㸧7 ᭶ 5 ᪥11JaCVAM ホ౯఍㆟኱ 㔝 Ὀ 㞝 㸦㐠Ⴀጤဨ఍᥎⸀㸧㸸ᗙ㛗㣤 ሯ ᑦ ᩥ 㸦⊂❧⾜ᨻἲே ་⸆ရ་⒪ᶵჾ⥲ྜᶵᵓ㸧஬༑ᔒⰋ᫂㸦ᅜ❧་⸆ရ㣗ရ⾨⏕◊✲ᡤ㸧▼ ஭ 㞝 ஧ 㸦ᅜ❧་⸆ရ㣗ရ⾨⏕◊✲ᡤ Ᏻ඲ᛶ⏕≀ヨ㦂◊✲ࢭࣥࢱ࣮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 ᪥                 JaCVAM ホ౯఍㆟኱ 㔝 Ὀ 㞝 㸦㐠Ⴀጤဨ఍᥎⸀㸧㸸ᗙ㛗㣤 ሯ ᑦ ᩥ 㸦⊂❧⾜ᨻἲே ་⸆ရ་⒪ᶵჾ⥲ྜᶵᵓ㸧஬༑ᔒⰋ᫂ 㸦ᅜ❧་⸆ရ㣗ရ⾨⏕◊✲ᡤ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᳃ ⏣  ೺ 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 ᪥22෌ᵓ⠏ࣄࢺゅ⭷ᵝୖ⓶ࣔࢹࣝἲ㸦Reconstructed human Cornea-like Epithelium Test Method: RhCE ἲ㸧ࡣࠊ࢘ࢧࢠࢆ⏝࠸ࡓ Draize ║่⃭ᛶヨ㦂ἲࡢ௦᭰ἲ࡜ࡋ࡚ࠊ⿕㦂≀㉁ࡢࣄࢺゅ⭷ᵝୖ⓶ࣔࢹࣝ⤌⧊࡟ᑐࡍࡿ⣽⬊ẘᛶࢆᣦᶆ࡟⏝࠸ࠊࡑࡢ≀㉁ࡢ║่⃭ᛶࢆホ౯ࡍࡿヨ㦂ἲ࡛࠶ࡿࠋ
࣎ࢺ࣒࢔ࢵࣉ᪉ᘧ࡟࠾࠸࡚ United Nations Globally Harmonized System of Classification and Labelling ofChemicals㸦UN GHS㸧༊ศእ≀㉁ࢆ᳨ฟࡍࡿ᪉ἲ࡜ࡋ࡚ࣂࣜࢹ࣮ࢩࣙࣥࡀ⾜ࢃࢀ 1)ࠊ2015 ᖺ࡟ OECD
TG492 ࡜ࡋ࡚᥇ᢥࡉࢀࡓ 2㸧ࠋJaCVAM ホ౯఍㆟ࡣࠊ║่⃭ᛶヨ㦂㈨ᩱ⦅⧩ጤဨ఍࡟ࡼࡾసᡂࡉࢀࡓࠕ෌
ᵓ⠏ࣄࢺゅ⭷ᵝୖ⓶ࣔࢹࣝἲ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㸧௦᭰ࡍࡿᑐ㇟ẘᛶヨ㦂㸸 Draize ║่⃭ᛶヨ㦂ἲ
ヨ 㦂 ἲ ࡢ ᴫ ␎ 㸸  RhCE ἲ ࡣ ࠊ ෌ ᵓ ⠏ ࣄ ࢺ ゅ ⭷ ᵝ ୖ ⓶ ࣔ ࢹ ࣝ 㸦 Reconstructed human Cornea-likeEpithelium:RhCE㸧⤌⧊ࢆ⏝࠸ࡓ║่⃭ᛶヨ㦂࡛࠶ࡿࠋRhCE ἲࡢ୍ࡘ࡛࠶ࡿ EpiOcularTM ࢆ⏝࠸ࡿ║่⃭ᛶヨ㦂ἲ㸦EpiOcularTM EIT㸧࡛ࡣࠊ⿕㦂≀㉁ࡀᾮయࡢሙྜࡣ⣙ 30 ศ㛫ࠊᅛయࡢሙྜࡣ⣙ 6 ᫬㛫ࠊࣄࢺゅ⭷ᵝୖ⓶ᵓ㐀ࢆ᭷ࡍࡿ⤌⧊࡟᭚㟢ࡋࡓᚋࠊMTT ࡢྲྀࡾ㎸ࡳ㔞ࢆࡶ࡜࡟ࡋࡓ⣽⬊⏕Ꮡ⋡ࢆᐃࡋࠊ║่⃭ᛶホ౯ࡢᣦᶆ࡜ࡋ࡚⏝࠸ࡿࠋࡇࢀࡣࠊMTT ࡀ࣑ࢺࢥࣥࢻࣜ࢔ࡢ⬺Ỉ⣲㓝⣲ࡢᇶ㉁࡜࡞ࡿ
ᛶ㉁ࢆ฼⏝ࡋࠊ⣽⬊ෆ࡟ྲྀࡾ㎸ࡲࢀࡓ MTT ࡀ⬺Ỉ⣲㓝⣲࡟ࡼࡾ㑏ඖࡉࢀࠊ⏕ᡂࡉࢀࡓ࣐࣍ࣝࢨࣥ㔞㸦㟷Ⰽ㸧ࡣ⏕Ꮡ⣽⬊ᩘ࡟ẚ౛ࡍࡿࡇ࡜࡟ᇶ࡙࠸࡚࠸ࡿ㸦MTT 㑏ඖἲ㸧ࠋ 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⭷ୖ⓶ᵝᵓ㐀ࢆ᭷ࡍࡿ RhCE ⤌⧊㸦EpiOcularTM㸧ࢆ⏝࠸࡚ࠊ⿕㦂≀㉁ࡢ⣽⬊ẘᛶࢆᣦᶆ࡜ࡋ࡚║่⃭ᛶࢆホ౯ࡍࡿヨ㦂ἲ࡛࠶ࡿࠋࡇࢀࡽࡢࡇ࡜࠿ࡽࠊᮏヨ㦂ἲࡣ࢘ࢧࢠࢆ⏝࠸ࡿ║่⃭ᛶヨ㦂ࡢ௦᭰ἲ࡜ࡋ࡚⛉Ꮫⓗጇᙜᛶࡀ࠶ࡿࠋ
EpiOcularTM EIT ࡟ࡘ࠸࡚ࡣࠊEURL ECVAM(European Union Reference Laboratory for Alternatives toAnimal Testing)࡜ CE(Cosmetics Europe)ࡢඹྠࣂࣜࢹ࣮ࢩࣙࣥヨ㦂 1)ࡀ⾜ࢃࢀࡓࠋࡑࡢヨ㦂࡛ࡣࠊṇ☜ᛶࡢホ౯ࡢࡓࡵ࡟ᚲせ࡞ື≀ヨ㦂ࡢࢹ࣮ࢱࢆᣢࡗ࡚࠸ࡿࡇ࡜ࢆ๓ᥦ᮲௳࡟ࠊUN GHS ༊ศ≀㉁࣭༊ศእ≀㉁ࡸᅛయ࣭ᾮయ➼ࡢࣂࣛࣥࢫࢆ⪃៖ࡋ࡚⿕㦂≀㉁ࡢ㑅ᢥࡀ⾜ࢃࢀࡓࠋࣂࣜࢹ࣮ࢩࣙࣥヨ㦂ࡣࠊࢥ࣮ࢻ໬
ࡉࢀࡓ 107 ≀㉁࡟ࡘ࠸࡚⾜ࢃࢀࡓࠋࡑࡢᚋࣉࣟࢺࢥࣝࡢ᭱㐺໬ࢆ⾜ࡗ࡚ࠊ᪂ࡓ࡞ᅛయ 8 ≀㉁ࢆ㏣ຍࡋࠊ115 ≀㉁࡛ホ౯ࡉࢀࡓࠋ33

EpiOcularTM EIT ࡣࠊ෌⌧ᛶࡶṇ☜ᛶࡶ EURL ECVAM ࣂࣜࢹ࣮ࢩࣙࣥ㐠Ⴀጤဨ఍ࡢᐃࡵࡓᇶ‽ࢆ‶ࡓࡋ࡚࠾ࡾࠊࡉࡽ࡟ ESAC ࡢ➨୕⪅ホ౯ 4)ࢆ⤒࡚ࠊUN GHS ༊ศእ≀㉁ࢆ᳨ฟࡍࡿ᪉ἲ࡜ࡋ࡚ 2015 ᖺ 7 ᭶࡟ OECD ࡟ࡼࡾヨ㦂࢞࢖ࢻࣛ࢖ࣥ࡟᥇ᢥࡉࢀࡓ㸦TG492㸧2)ࠋJaCVAM ║่⃭ᛶヨ㦂㈨ᩱ⦅⧩ጤဨ఍ࡣࠊ
ࡇࢀࡽࡢ㈨ᩱࢆ⏝࠸࡚ᮏヨ㦂ἲࢆホ౯ࡋ࡚࠾ࡾࠊ⛉Ꮫⓗ࡟ጇᙜ࡛࠶ࡿ࡜⪃࠼ࡿࠋ㸱㸬ᮏヨ㦂ἲࡢ᭷⏝ᛶ࡜㐺⏝㝈⏺
EpiOcularTM ࡣᕷ㈍ࡉࢀ࡚࠾ࡾࠊ⡿ᅜࡢ〇㐀ඖࡼࡾධᡭ࡛ࡁࡿࠋRhCE ⤌⧊௨እࡣࠊ≉Ṧ࡞ᶵᮦࡸヨ⸆ࢆᚲせ࡜ࡏࡎࠊ≉ู࡞ᡭᢏࡶᚲせ࡞࠸ࡇ࡜࠿ࡽᢏ⾡⛣㌿ᛶࡣ㧗࠸࡜ุ᩿࡛ࡁࡿࠋࣂࣜࢹ࣮ࢩࣙࣥヨ㦂࡟࠾࠸࡚ࡶࠊཧຍ᪋タࡢᢏ⾡⪅࡟ᑐࡋ࡚ᢏ⾡⩦ᚓࡢࡓࡵࡢࢺ࣮ࣞࢽࣥࢢࡀ⾜ࢃࢀࡓ⤖ᯝࠊᢏ⾡⛣㌿ᛶ࡟ၥ㢟ࡀ࡞࠿ࡗࡓࡇ࡜ࡀ☜ㄆࡉࢀ࡚࠸ࡿࠋణࡋࠊEpiOcularTM EIT ࢆᐇ᪋ࡍࡿヨ㦂᪋タࡢᢏ⾡⩦ᚓࢆ☜࠿ࡵࡿࡓࡵࡢ⇍㐩ᗘ☜ㄆ≀㉁ࡢ୍ぴࡀ TG492 ࡟ᐃࡵࡽࢀ࡚࠾ࡾࠊࡑࢀࡽࢆ⏝࠸࡚ᢏ⾡⛣㌿ࡀ㐩ᡂ࡛ࡁࡓࡇ࡜ࢆ☜࠿ࡵࡿᚲせࡀ࠶ࡿࠋUN GHS ༊ศእ≀㉁ࢆ᳨ฟࡍࡿ᪉ἲ࡜ࡋ࡚ࡢጇᙜᛶࢆㄪ࡭ࡿࡓࡵࡢࣂࣜࢹ࣮ࢩࣙࣥヨ㦂࡟࠾࠸࡚᪋タෆ෌⌧ᛶࡣࠊUN GHS ศ㢮ุᐃࡢ᪋タࡈ࡜ࡢ᪋タෆ෌⌧ᛶࡣ EURL ECVAM-CE ࣂࣜࢹ࣮ࢩࣙࣥ㐠Ⴀጤဨ఍ࡀᐃࡵࡓᇶ‽㸦85%௨ୖ㸧ࢆ‶ࡓࡋ࡚࠸ࡓ 1)ࠋࡲࡓࠊ᪋タ㛫෌⌧ᛶ࡟㛵ࡋ࡚ࡣࠊᮏヨ㦂࡛ᚓࡽࢀࡓ⣽⬊⏕Ꮡ⋡㸦」ᩘᅇヨ㦂㸧ࡢᖹᆒ್ࢆࡶ࡜࡟ UN GHS ศ㢮ุᐃࢆ᪋タࡈ࡜࡟⾜࠸ࠊࡑࡢ୍⮴ᗘࢆ᳨ウࡋࡓ㸦ᅛయ≀㉁ࡢࢹ࣮ࢱࢆྵࡴ㸧ࠋࡑࡢ⤖ᯝࠊࣂࣜࢹ࣮ࢩࣙࣥ㐠Ⴀጤဨ఍ࡀᐃࡵࡓᇶ‽㸦80%௨ୖ㸧ࢆ‶ࡓࡋ࡚࠸ࡓ 1)ࠋ
UN GHS ༊ศእ≀㉁ࢆ᳨ฟࡍࡿ᪉ἲ࡜ࡋ࡚ヨ㦂ἲࡢṇ☜ᛶ࡟㛵ࡋ࡚ࡣࠊ≀㉁⮬యࡢⰍࡀ࣐࣍ࣝࢨࣥᐃ
㔞࡛ࡢ྾ගᗘᐃࢆጉࡆࡿ 3 ≀㉁࡜ࠊᙉ࠸㑏ඖᛶ≀㉁ 1 ≀㉁ࢆ㝖ࡃ 111 ≀㉁ࡢ⤖ᯝࢆ⏝࠸࡚ホ౯ࡀ⾜ࢃࢀࡓࠋࡑࡢ⤖ᯝࠊୗグࡢࡼ࠺࡟ࠊᾮయ≀㉁ࡢࡳࡢሙྜࠊᅛయ≀㉁ࡢࡳࡢሙྜ࠾ࡼࡧᾮయ≀㉁࣭ᅛయ≀㉁ࢆྵࡵࡓሙྜ࡟ศࡅ࡚ゎᯒࡋࡓሙྜࡢ࠸ࡎࢀ࡟࠾࠸࡚ࡶࠊ୍⮴ᗘࠊഇ㝜ᛶ⋡ࠊഇ㝧ᛶ⋡ࡣࣂࣜࢹ࣮ࢩࣙࣥ㐠Ⴀጤဨ఍ࡀᐃࡵࡓཷࡅධࢀᇶ‽ 1)ࢆ‶ࡓࡋ࡚࠸ࡓࠋEpiOcularTM EIT ࡢṇ☜ᛶ≀㉁ᩘ

୍⮴ᗘ(%)

ഇ㝜ᛶ⋡(%)

ഇ㝧ᛶ⋡(%)

ᾮయ

52

81.9

1.7

33.3

ᅛయ

59

78.0

6.5

39.3

ᾮయ࣭ᅛయ

111

79.7

4.337.0௦᭰ἲ࡜ࡋ࡚ࡢཷࡅධࢀᇶ‽ 1)- 75

 10 40║่⃭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࠸࡚ࡣࠊTG492 ࡢᮏᩥࡢㄝ᫂࠾ࡼࡧ ANNEX II ࡢࣇ࣮ࣟࢳࣕ
࣮ࢺࢆཧ↷ࡍࡿᚲせࡀ࠶ࡿࠋ44ࡲࡓࠊᮏヨ㦂ἲࢆ㐺⏝ࡍࡿ࡟ࡣࠊヨ㦂ἲࡢᛶ㉁࡜ṇ☜ᛶࡢ☜ಖࢆ⪃៖ࡋ࡚௨ୗࡢไ㝈ࡀタࡅࡽࢀࡿࠋ1) ࣂࣜࢹ࣮ࢩࣙࣥヨ㦂࡟࠾࠸࡚⿕㦂≀㉁࡟ྵࡵࡽࢀ࡞࠿ࡗࡓẼయ㸦࢞ࢫ㸧࠾ࡼࡧ࢚࢔ࢰ࣮ࣝࡣ㐺⏝≀㉁࠿ࡽ㝖እࡉࢀࡿࠋ2) UN GHS ༊ศ 1ࠊ༊ศ 2㸦2A࣭2B㸧≀㉁ࡢ᳨ฟ࡟ࡣ⏝࠸ࡿࡇ࡜ࡣ࡛ࡁ࡞࠸ࠋ
ࣂࣜࢹ࣮ࢩࣙࣥヨ㦂࡟⏝࠸ࡽࢀࡓΰྜ≀ࡢᩘࡣ㝈ࡽࢀ࡚࠸ࡓࡀࠊࣂࣜࢹ࣮ࢩࣙࣥヨ㦂࡜ࡣู࡟ࠊື≀ヨ㦂ࡢࢹ࣮ࢱࡀ࠶ࡿ㎰⸆ฎ᪉㸦97 ฎ᪉ࠊ࠺ࡕ༊ศእࡣ 43 ฎ᪉㸧ࢆ⏝࠸࡚ホ౯ࡀ⾜ࢃࢀࡓ 5)ࠋ⤖ᯝࡣ୍⮴ᗘ 82%ࠊഇ㝜ᛶ⋡ 9%ࠊഇ㝧ᛶ⋡ 28%࡛ࠊࡇࢀࡽࡣࣂࣜࢹ࣮ࢩࣙࣥ㐠Ⴀጤဨ఍ࡀᐃࡵࡓཷࡅධࢀᇶ‽ࢆ‶ࡓࡋ࡚࠸ࡿࡇ࡜࠿ࡽࠊΰྜ≀࡟ࡶ㐺⏝࡛ࡁࡿྍ⬟ᛶࡀ࠶ࡿࠋ
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♫఍ⓗཷࡅධ࠾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࠸ࡿࠋࡲࡓࠊEpiOcularTM ࡢධᡭࡣᐜ࡛᫆ࠊ▷᫬㛫࡛Ᏻ౯࡟ᐇ᪋࡛ࡁࠊ≉Ṧ࡞ᶵᮦࡸヨ⸆ࢆᚲせ࡜ࡏࡎࠊᚲせ࡞ᡭᢏࡶ」㞧࡞ࡶࡢ࡛࡞࠸ࠋࡋࡓࡀࡗ࡚ࠊධᡭࡋࡓ EpiOcularTM 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 ⾜ᨻୖࡢ฼⏝ᛶ㸸ᮏヨ㦂ἲࡣࠊ໬Ꮫ≀㉁࡟ࡼࡿ║่⃭ᛶࢆホ౯࡛ࡁࠊ࣎ࢺ࣒࢔ࢵࣉ᪉ᘧ࡟࠾࠸࡚ UN GHS ༊ศእࢆ᳨ฟ
ࡍࡿ᪉ἲ࡜ࡋ࡚ࠊ⾜ᨻⓗ฼⏝ࡀྍ⬟࡛࠶ࡿ࡜⪃࠼ࡿࠋ࡞࠾ࠊEpiOcularTM EIT ௨እࡢ RhCE ἲࢆ⏝࠸ࡿሙྜ࡟ࡣࠊOECD TG492 ࡢᛶ⬟ᶆ‽࡟グ㍕ࡉࢀࡓ≀㉁ࢆ⏝࠸࡚ 6)ࠊࡑࡢጇᙜᛶࢆ☜ㄆࡋ࡚࠾ࡃᚲせࡀ࠶ࡿࠋ55ཧ⪃ᩥ⊩1) 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.
2) OECD (2015) Test Guideline 492. Reconstructed human Cornea-like Epithelium (RhCE) test method foridentifying chemicals not requiring classification and labelling for eye irritation or serious eye damage.
3) JaCVAM ║่⃭ᛶ௦᭰ἲ㈨ᩱ⦅⧩ጤဨ఍㸸OECD TG492 ࣄࢺゅ⭷ᵝୖ⓶ࣔࢹࣝἲ (Reconstructed
Human Cornea-like Epithelium Test Method: RhCEἲ)ホ౯ሗ࿌᭩㸦2016ᖺ1᭶25᪥㸧4) ESAC (2014) ESAC Opinion based on the ESAC Scientific Peer Review of the ECVAM Eye Irritation
Validation Study (EIVS) and a related Cosmetics Europe study on HPLC/UPLC-photometry as an alternative
endpoint detection system for formazan reaction product.
5) Kolle SN et al. (2015) The EpiOcularTM eye irritation test is the method of choice for the in vitro eye irritation
testing of agrochemical formulations: Correlation analysis of EpiOcular Eye Irritation Test and BCOP test dataaccording to UN GHS, US EPA and Brazil ANVISA classification schemes. ATLA. 43, 181-198.
6) OECD (2015) Series on Testing & Assessment 216. Performance standards for the assessment of proposed
similar or modified in vitro Reconstructed human Cornea-like Epithelium (RhCE) test method for eye hazard

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