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SHE⣽⬊ᙧ㉁㌿᥮ヨ㦂ἲ㸦SHE CTA㸧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⣽⬊ᙧ㉁㌿᥮ヨ㦂㸦Cell Transformation Assay㸸CTA㸧ࡣࠊᇵ㣴⣽⬊࡟໬Ꮫ≀㉁ࢆ᭚㟢ࡍࡿࡇ࡜࡛㉳ࡁࡿࠕ⣽⬊ࡢᙧែࠖࡸࠕ⾲⌧ᙧ㉁ࠖࡢኚ໬ࢆᣦᶆ࡜ࡋ࡚⭘⒆ㄏⓎᛶࡢ᭷↓ࢆㄪ࡭ࡿヨ㦂ἲࡢ୍ࡘ࡛࠶ࡿࠋࢩࣜ࢔࣭ࣥࣁ࣒ࢫࢱ࣮⫾ඣ㸦Syrian Hamster Embryo㸸SHE㸧⣽⬊ࢆ⏝࠸ࡿ CTA ࡛ࡣࠊึ௦ᇵ㣴⣽⬊ࢆ෾⤖࣭ゎ෾ࡋࡓṇᖖ஧ಸయ⣽⬊ࢆ⏝࠸࡚ࠊ┠ⓗ࡜ࡍࡿ໬Ꮫ≀㉁ࢆ᭚㟢ࡋࡓᚋࠊᙧែᙧ㉁㌿᥮ࢥࣟࢽ࣮ࡢฟ⌧⋡࡟ࡼࡗ࡚ࠊ໬Ꮫ≀㉁ࡢᙧ㉁㌿᥮⬟ࡢ᭷↓ࢆホ౯ࡍࡿࠋSHE CTA ࡟ࡘ࠸࡚ࡣࠊOECD ࡟ࡼࡾ Detailed Review Paper 31㸦DRP31㸧࡛ 245 ࡢ໬Ꮫ≀㉁ࡀホ౯ࡉࢀ࡚࠸ࡿ 1)ࠋEuropean Union Reference Laboratory for Alternatives to Animal Testing㸦EURL ECVAM㸧࡟ࡼࡿࣉࣞࣂࣜࢹ࣮ࢩࣙࣥ◊✲ࡀᐇ᪋ࡉࢀ 2-3)ࠊEURL ECVAM Scientific Advisory Committee㸦ESAC㸧࡟ࡼࡿ➨3 ⪅ホ౯ࡀ⾜ࢃࢀ 4)ࠊ࢞࢖ࢻࣛ࢖ࣥ໬ࡀ᥎ዡࡉࢀࡓ 5)ࠋࡑࡢᚋࠊSHE CTA ᑓ㛛ᐙ఍㆟࡟ࡼࡿ෌ホ౯ࡀ⾜ࢃࢀ 6-7)ࠊ2015 ᖺ 5 ᭶࡟ OECD ࢞࢖ࢲࣥࢫ࡜ࡋ࡚බ⾲ࡉࢀ࡚࠸ࡿ 8)ࠋJaCVAM ホ౯఍㆟ࡣࠊJaCVAM ᙧ㉁㌿᥮ヨ㦂㈨ᩱ⦅⧩ጤဨ఍࡟ࡼࡾసᡂࡉࢀࡓࠕSHE ⣽⬊ᙧ㉁㌿᥮ヨ㦂ἲ㸦SHE CTA㸧ホ౯ሗ࿌᭩ࠖ9)ࢆ
⏝࠸࡚ࠊᮏヨ㦂ἲࡢጇᙜᛶ࡟ࡘ࠸᳨࡚ウࡋࡓࠋ㸯㸬ヨ㦂ἲࡢᐃ⩏ྡ⛠㸸 SHE ⣽⬊ᙧ㉁㌿᥮ヨ㦂ἲ㸦SHE CTA㸧௦᭰ࡍࡿᑐ㇟ẘᛶヨ㦂㸸 ࡆࡗṑ㢮ࢆ⏝࠸ࡿࡀࢇཎᛶヨ㦂ヨ㦂ἲࡢᴫ␎㸸 ᮏヨ㦂ἲ࡛ࡣࠊ⫾⏕ 13 ᪥┠ࡢࢩࣜ࢔࣭ࣥࣁ࣒ࢫࢱ࣮࠿ࡽㄪ〇ࡋࡓึ௦ᇵ㣴⣽⬊࠿ࡽస〇ࡋࡓ 2 ௦┠ࡢ⣽⬊㸦ṇᖖ஧ಸయ䠅ࢆ⏝࠸ࡿࠋ୍㒊ࡣ X ⥺↷ᑕ࡟ࡼࡾቑṪ⬟ࢆ୙ά໬ࡉࡏࡓࣇ࢕࣮ࢲ࣮⣽⬊㸦ᨭᣢ⣽⬊㸧࡜ࡋ࡚ࠊ௚ࡣᙧ㉁㌿᥮⬟ࢆㄪ࡭ࡿᶆⓗ⣽⬊࡜ࡋ࡚౑⏝ࡍࡿࠋࣇ࢕࣮ࢲ࣮⣽⬊ୖ࡟ᶆⓗ⣽⬊ࢆ᧛✀ࡋࡓᚋࠊ⿕㦂≀㉁ࢆ 7 ᪥㛫᭚㟢ࡋࡓᚋࠊ⣽⬊ࢆὙί࣭ᅛᐃࡋ࡚ᰁⰍࡋࠊᐇయ㢧ᚤ㙾ୗ࡛ࢥࣟࢽ࣮ࡢᙧែࢆㄪ࡭ࡿࠋ⣽⬊ẘᛶࡣࠊࢥࣟࢽ࣮ᙧᡂຠ⋡࡜ࢥࣟࢽ࣮ࡢ኱ࡁࡉࡸ⣽⬊ᐦᗘࡢῶᑡ࠿ࡽホ౯ࡍࡿࠋᙧ㉁㌿᥮⬟ࡣࠊ⿕㦂≀㉁᭚㟢⩌࡜⁐፹ᑐ↷⩌࡟ࡘ࠸࡚ࠊࡑࢀࡒࢀࢥࣟࢽ࣮ࡢ⥲ᩘ࡟ᑐࡍࡿᙧែᙧ㉁㌿᥮ࢥࣟࢽ࣮ᩘࡢ๭ྜࢆ⟬ฟࡋ࡚ẚ㍑ࡍࡿࡇ࡜࡟ࡼࡾホ౯ࡍࡿࠋ㸰㸬ホ౯࡟⏝࠸ࡓ㈨ᩱ࠾ࡼࡧホ౯ෆᐜࡢ⛉Ꮫⓗጇᙜᛶᮏヨ㦂ἲࡣࠊEURL ECVAM ࡟ࡼࡿ 6 ✀㢮ࡢ໬Ꮫ≀㉁ࢆ⏝࠸ࡓࣉࣞࣂࣜࢹ࣮ࢩࣙࣥ◊✲ 2-3)࡜ࡑࢀ࡟⥆ࡃ ESAC ࡟ࡼࡿ➨୕⪅ホ౯࡟ࡼࡾࠊ့ங㢮ࢆ⏝࠸ࡓࡀࢇཎᛶヨ㦂ࡢ௦᭰ἲ࡜ࡋ࡚ホ౯ࡉࢀ࡚࠸ࡿ 4)ࠋ
OECD ࢞࢖ࢲࣥࢫ 34 ࡟ᇶ࡙࠸ࡓࣂࣜࢹ࣮ࢩࣙࣥ◊✲ࡣᐇ᪋ࡉࢀ࡚࠸࡞࠸ࡀࠊ2015 ᖺ 5 ᭶࡟බ⾲ࡉࢀࡓ
OECD ࢞࢖ࢲࣥࢫ 8)࡛ࡣࠊࡀࢇཎᛶࢆホ౯ࡍࡿヨ㦂ᡓ␎ࡢ୍⎔࡜ࡋ࡚ࠊ࠶ࡿ࠸ࡣࡀࢇཎᛶ࡟࠿࠿ࡿドᣐࡢ㔜ࡳ࡙ࡅ㸦Weight of Evidence㸸WoE㸧࡟ᮏヨ㦂ࡢ⤖ᯝࢆ฼⏝ࡍࡿࡇ࡜ࡣ᭷⏝࡛࠶ࡿ࡜ࡉࢀ࡚࠸ࡿࠋJaCVAM ᙧ㉁㌿᥮ヨ㦂㈨ᩱ⦅⧩ጤဨ఍࡛ࡣࠊ⌧ᅾࡲ࡛බ㛤ࡉࢀ࡚࠸ࡿ᝟ሗ 1-8)ࢆᇶ࡟ᮏヨ㦂ἲࡢࡀࢇཎ
ᛶヨ㦂௦᭰ἲ࡜ࡋ࡚ࡢ⛉Ꮫⓗጇᙜᛶ࡟ࡘ࠸࡚ホ౯ࡋࡓࠋSHE ⣽⬊ࡢᙧែᙧ㉁㌿᥮ࡣࠊከẁ㝵Ⓨࡀࢇ㐣⛬ࡢ᪩ᮇ࡟㉳ࡁࡿ⌧㇟࡟┦ᙜࡋ࡚࠾ࡾࠊᙧ㉁㌿᥮⣽⬊ࡣࠊ⥅௦ᇵ㣴ᚋࠊྠ⣔⤫ࡢື≀ࡸࢾ࣮ࢻ࣐࢘ࢫ࡟ᑐࡋ࡚⣙ 50㹼100㸣ࡢ๭ྜ࡛㐀⭘⒆ᛶࢆ♧ࡍࡇ࡜ࡀ▱ࡽࢀ࡚࠸ࡿ 10-11)ࠋDRP31 ࡟ࡣࠊ」ᩘࡢ pH ࡢᇵ㣴ᾮ33㸦౛࠼ࡤࠊpH 6.7ࠊpH 7.0 ࠶ࡿ࠸ࡣࡑࢀ௨ୖ㸧࡛ヨ㦂ࡉࢀࡓᩘከࡃࡢ໬Ꮫ≀㉁ࡢ SHE CTA ⤖ᯝࡀࡲ࡜ࡵࡽࢀࠊ㑇ఏẘᛶࡀࢇཎ≀㉁࠾ࡼࡧ㠀㑇ఏẘᛶࡀࢇཎ≀㉁ࡢ᭚㟢࡟ࡼࡾࠊSHE ⣽⬊ࡣᙧែᙧ㉁㌿᥮ࡍࡿࡇ࡜ࡀ♧ࡉࢀ࡚࠸ࡿࠋEURL ECVAM ࡣࠊᶆ‽ࣉࣟࢺࢥࣝࠊᢏ⾡⛣㌿ᛶࠊ࠾ࡼࡧ᪋タෆ෌⌧ᛶ୪ࡧ࡟᪋タ㛫෌⌧ᛶࢆホ౯ࡋࡓ⤖ᯝࠊࡑࡢ᭷⏝ᛶࢆㄆࡵ࡚࠸ࡿࠋࡲࡓࠊEURL ECVAM ࡢᶆ‽ⓗࣉࣟࢺࢥࣝ࡜ DRP31࡟♧ࡉࢀࡓࣉࣟࢺࢥࣝ࡜ࡢ㛫࡟ࡣᇶᮏⓗ࡞ᕪ␗ࡣ࡞ࡃࠊᅇ㢳ⓗホ౯࡟࠾࠸࡚ࠊ࠸ࡎࢀࡢࣉࣟࢺࢥࣝ࡟ࡼࡾᚓࡽࢀࡓࢹ࣮ࢱࡶࠊཷࡅධࢀྍ⬟࡛࠶ࡿ࡜ࡉࢀࡓࠋ⣽⬊ࡢᙧ㉁㌿᥮ࡢṇ☜࡞ศᏊ⏕≀Ꮫⓗ࣓࢝ࢽࢬ࣒ࡣ༑ศ࡟ࡣゎ᫂ࡉࢀ࡚࠾ࡽࡎࠊSHE ⣽⬊ࡢᙧ㉁㌿᥮࣓࢝ࢽࢬ࣒࡟ࡶ୙᫂࡞Ⅼࡀከ࠸ࡀࠊࡑࡢ࣓࢝ࢽࢬ࣒ࢆゎᯒࡍࡿㄽᩥࡣᩘከࡃ࠶ࡿࠋ⣽⬊࿘ᮇไᚚࢩࢫࢸ࣒ࠊࢤࣀ࣒Ᏻᐃᛶࠊ࠾ࡼࡧศ໬࣭ቑṪ㐣⛬࡛ࡢ㑇ఏᏊⓎ⌧ࡢኚ໬ࡸ␗ᖖࡀᙧ㉁㌿᥮ࡢ୺ࡓࡿせᅉ࡜ࡋ࡚⪃࠼ࡽࢀ࡚࠸ࡿࠋࡇࢀࡽࡢ㐣⛬࡟ᙳ㡪ࢆཬࡰࡍ㑇ఏⓗኚ␗ࡣ┤᥋ⓗ࡞㑇ఏẘᛶస⏝࡜⪃࠼ࡽࢀ࡚࠸ࡿࠋࡉࡽ࡟ࠊDNA ࡢ㧗࣓ࢳࣝ໬࠶ࡿ࠸ࡣప࣓ࢳࣝ໬ࠊࣄࢫࢺࣥಟ㣭࠾ࡼࡧࢾࢡࣞ࢜ࢯ࣮࣒ࣜࣔࢹࣜࣥࢢ࡟ࡼࡿ㑇ఏᏊⓎ⌧ࡢኚ໬ࡸ㑇ఏⓗ୙Ᏻᐃᛶࡀࠊ࢚ࣆࢪ࢙ࢿࢸࢵࢡ࡞ኚ໬ࢆㄏ㉳ࡋࠊᝏᛶᙧ㉁㌿᥮࡬࡜㐍⾜ࡉࡏࡿᘬࡁ㔠࡟࡞ࡿ࡜⪃࠼ࡽࢀ࡚࠸ࡿࠋ㠀㑇ఏẘᛶࡀࢇཎ≀㉁ࡶࡲࡓࠊከẁ㝵Ⓨࡀࢇ㐣⛬࡟㛵୚ࡋࠊṇᖖ⣽⬊ࢆᙧ㉁㌿᥮ࡉࡏࡿࡶࡢ࡜⪃࠼ࡽࢀ࡚࠸ࡿࠋࡍ࡞ࢃࡕࠊࢠࣕࢵࣉࢪࣕࣥࢡࢩࣙࣥ࡟ࡼࡿ⣽⬊㛫ࢥ࣑ࣗࢽࢣ࣮ࢩࣙࣥࢆ㜼ᐖࡍࡿ㓟໬ⓗࢫࢺࣞࢫࠊ⣽⬊ศ⿣ᅇᩘࡢቑຍࠊ࢔࣏ࢺ࣮ࢩࢫࡢῶᑡࠊࢳࣗࣈࣜࣥྜᡂ㜼ᐖࠊࢸ࣓࣮ࣟࣛࢮࡢάᛶ໬࡟ࡼࡿ⪁໬ࡢ㜼ᐖࠊࢩࢢࢼࣝఏ㐩㐣⛬ࡢ㜼ᐖࠊࡲࡓࠊ࣍ࣝࣔࣥ௓ᅾ㐣⛬ࡸ࣌ࣝ࢜࢟ࢩࢰ࣮࣒ࡢቑṪ࡟㛵୚ࡍࡿཷᐜయ࡬ࡢ⤖ྜ࡞࡝࡛࠶ࡿࠋࡇࡢࡼ࠺࡞⛉Ꮫⓗ▱ぢࡢከࡃࡀࠊࡀࢇ໬㐣⛬ุ࡛᫂ࡋ࡚࠸ࡿ஦ᐇ࡜ࡑࡢ୍㒊ࡀᩚྜࡍࡿࡇ࡜࡞࡝࠿ࡽࠊSHE CTA ࡢ⛉Ꮫⓗ࡞᳨ドࡣࠊ᏶඲࡛ࡣ࡞࠸ࡶࡢࡢࠊ⌧ᅾࡢศᏊ⏕≀ᏛⓗỈ‽࡟ᇶ࡙࠸࡚࠶ࡿ⛬ᗘ࡞ࡉࢀ࡚࠸ࡿ࡜⪃࠼ࡽࢀࡿࠋ㸱㸬ᮏヨ㦂ἲࡢ᭷⏝ᛶ࡜㐺⏝㝈⏺
ᮏヨ㦂ἲࡣࠊᇵ㣴ṇᖖ⣽⬊ࡀᙧែᙧ㉁㌿᥮ࡍࡿࡇ࡜ࢆᣦᶆ࡟ࡋ࡚ࠊ໬Ꮫ≀㉁ࡢ⭘⒆ㄏⓎᛶࡢ᭷↓ࢆணࡍࡿヨ㦂ἲࡢ୍ࡘ࡛࠶ࡾࠊ௚ࡢࡀࢇཎᛶண

ヨ㦂⤖ᯝ࡜࡜ࡶ࡟ࠊWoE ࡢ୍ࡘ࡜ࡋ࡚ SHE CTA ࡢ⤖ᯝࢆ฼⏝ࡍࡿࡇ࡜ࡀ࡛ࡁࡿࠋᮏヨ㦂ἲࡣࠊ⌧⾜ࡢࡀࢇཎᛶヨ㦂࡟᏶඲࡟⨨ࡁ᥮ࢃࡿヨ㦂ἲ࡜ࡋ࡚ࡢ఩⨨࡙ࡅ࡛ࡣ࡞ࡃࠊ⿵ຓⓗ࡞ヨ㦂㸦౛࠼ࡤࠊࡀࢇཎᛶヨ㦂ࡢᐇ᪋㡰఩ࢆỴࡵࡿࡓࡵࡢࢫࢡ࣮ࣜࢽࣥࢢ࡞࡝㸧࡜ࡋ࡚఩⨨࡙ࡅࡿࡇ࡜ࡣྍ⬟࡛࠶ࡿࠋᮏヨ㦂ἲ࡛ࡣࠊື≀⫾ඣ࠿ࡽึ௦ᇵ㣴⣽⬊ࢆㄪ〇ࡍࡿᚲせࡀ࠶ࡿࡀࠊ⏝࠸ࡿື≀ᩘࡣࠊࡀࢇཎᛶヨ㦂࡟ẚ࡭࡚ࡣࡿ࠿࡟ᑡ࡞ࡃࠊ3Rs ࡢほⅬ࠿ࡽ᭷⏝࡛࠶ࡿࠋࡲࡓࠊᮏヨ㦂ἲࡣࠊึ௦ᇵ㣴⣽⬊࠿ࡽస〇ࡋࡓ 2 ௦┠ࡢ⣽⬊㸦ṇᖖ஧ಸయ䠅ࢆ⏝࠸ࡿࡇ࡜࠿ࡽࠊ୙Ṛ໬ᇵ㣴⣽⬊ࢆ⏝࠸ࡿ CTA ࡜ẚ㍑ࡋ࡚ࠊࡑࡢ཯ᛂࡣࡼࡾṇᖖ⣽⬊࡟㏆࠸≧ែࢆ཯ᫎࡋࡓ⣔࡜⪃࠼ࡽࢀࡿࠋ
DRP31 ࡛ࡢ 245 ࡢ໬Ꮫ≀㉁ࢆホ౯ࡋࡓ⤖ᯝ࡟࠾࠸࡚ࠊSHE CTA ࡢ⤖ᯝ࡜ࡀࢇཎᛶヨ㦂⤖ᯝ࡜ࡢ┦㛵ࡀㄆࡵࡽࢀࡿࠋSHE CTA ࡢṇ☜ᛶ࡟ࡘ࠸࡚ࡣࠊື≀ࢆ⏝࠸ࡓࡀࢇཎᛶヨ㦂࡜ࡢṇ☜ᗘࠊឤᗘࠊ≉␗ᗘࠊഇ㝜ᛶ⋡࠾ࡼࡧഇ㝧ᛶ⋡ࡀࠊࡀࢇཎ≀㉁ࢆ᳨ฟࡍࡿ㑇ఏẘᛶヨ㦂ࢹ࣮ࢱ࡜ᴫࡡྠ➼ཪࡣࡑࢀ௨ୖࡢ⤖ᯝࡀᚓࡽࢀ࡚࠸ࡿࠋࡍ࡞ࢃࡕࠊ␗࡞ࡿᇵ㣴ᾮ pH ࡟࠾ࡅࡿ SHE CTA ࡢṇ☜ᛶࡢ෌ホ౯࡛ࡣࠊpH 6.7 ἲ㸦93໬Ꮫ≀㉁㸧ࡣࠊṇ☜ᗘ 73㸣ࠊឤᗘ 72㸣ࠊ≉␗ᗘ 74㸣࡛ࠊpH 7.0 ἲ㸦42 ໬Ꮫ≀㉁㸧ࡣࠊṇ☜ᗘ 83㸣ࠊឤ

44ᗘ 80㸣ࠊ≉␗ᗘ 92㸣࡛࠶ࡗࡓࠋ࠸ࡎࢀࡢ pH ࡛ࡶࠊᴫࡡྠ➼ࡢ⤖ᯝࡀᚓࡽࢀ࡚࠾ࡾࠊඹ࡟ࡑࡢ᭷⏝ᛶࡣ㧗࠸࡜⪃࠼ࡽࢀࡿࠋ୍᪉ࠊᮏヨ㦂࡟ࡘ࠸࡚ࡣከ✀㢮ࡢ໬Ꮫ≀㉁ࢆ⏝࠸ࡓࣂࣜࢹ࣮ࢩࣙࣥ◊✲ࡀᐇ᪋ࡉࢀ࡚࠾ࡽࡎࠊヨ㦂᪉ἲࡀ༑ศ࡟᳨ドࡉࢀࡓ࡜ࡣゝ࠸㞴࠸ࠋࡲࡓࠊᮏヨ㦂ࡢ⤖ᯝࡀ㝧ᛶ࡛࠶ࡗ࡚ࡶࠊࡑࡢ໬Ꮫ≀㉁ࡢື≀࡟࠾ࡅࡿࡀࢇཎᛶࡢᙉࡉࠊ⮚ჾ≉␗ᛶࠊ✀≉␗ᛶ࠾ࡼࡧస⏝ᶵᗎ㸦࢖ࢽࢩ࢚࣮ࢩࣙࣥ/ࣉ࣮ࣟࣔࢩࣙࣥస⏝㸧࡟㛵ࡍࡿ᝟ሗࡣᚓࡽࢀ࡞࠸ࠋࡉࡽ࡟ࠊᙧ㉁㌿᥮ࢥࣟࢽ࣮ࡢุู࡟ࡣᐇ㦂⪅ࡢ⩦⇍㸦༑ศ࡞ᩍ⫱カ⦎࠾ࡼࡧ⤒㦂㸧ࡀᚲせ࡛࠶ࡿࠋヨ㦂ࢆ㐺ษ࡟ᐇ᪋ࡍࡿ࡟ࡣࠊ௨ୗࡢ஦㡯ࢆ⪃៖ࡍࡿᚲせࡶ࠶ࡿ㸸1) ㄪ〇ࡋࡓSHE ⣽⬊࠾ࡼࡧ౑⏝ࡍࡿ࢘ࢩ⫾ඣ⾑Ύࡢ㐺ษᛶࠊ2) ࣇ࢕࣮ࢲ࣮⣽⬊ࡢ㐺ษᛶ࡜ࡑࡢㄪ〇࡟࠾ࡅࡿ X ⥺↷ᑕ⿦⨨ࡢ౑⏝ࠊ3) ヨ㦂ᡂ❧ᇶ‽࠾ࡼࡧ⤖ᯝุᐃᇶ‽ࡢタᐃࠋ㸲㸬┠ⓗ࡜ࡍࡿ≀㉁ཪࡣ〇ရࡢẘᛶࢆホ౯ࡍࡿヨ㦂ἲ࡜ࡋ࡚ࡢࠊ♫఍ⓗཷࡅධࢀᛶ࠾ࡼࡧ⾜ᨻୖࡢ฼⏝ࡢྍ⬟ᛶ ♫఍ⓗཷࡅධࢀᛶ㸸ᮏヨ㦂ἲࡣࠊᐇ᪋࡟㝿ࡋ✀ࠎࡢ᮲௳ࡀ࠶ࡿࡶࡢࡢࠊ⣽⬊ᇵ㣴࡞ࡽࡧ࡟ᙧ㉁㌿᥮ࢥࣟࢽุู࣮࡟⩦⇍ࡋࡓ᪋タ࡛࠶ࢀࡤᐇ᪋࡛ࡁࠊᇵ㣴ᮇ㛫ࡶ㸯㐌㛫⛬ᗘ࡜▷ࡃࠊࡲࡓヨ㦂㈝⏝ࡶẚ㍑ⓗᏳ౯࡛࠶ࡿࠋ୍༉ࡢዷፎື≀⏤᮶ࡢ⫾ඣ⣽⬊࠿ࡽ 50 ᅇࡢホ౯ࡀྍ⬟࡞ᇵ㣴⣽⬊ࡀᚓࡽࢀࡿ࡜࠸࠺Ⅼ࡛ࠊ3Rs ࡢ⢭⚄࡟ྜ⮴ࡋ࡚࠾ࡾࠊ♫఍ⓗཷࡅධࢀᛶࡣ㧗࠸ࠋ ⾜ᨻୖࡢ฼⏝ᛶ㸸ᮏヨ㦂ἲ࡟࠾࠸࡚㝧ᛶࡢ⤖ᯝࡀᚓࡽࢀࡓሙྜࠊࡑࡢ⿕㦂≀㉁ࢆࡀࢇཎᛶ≀㉁࡜ุᐃࡍࡿࡇ࡜ࡣ⛉Ꮫⓗ࡟ࡶࠊࡲࡓ⾜ᨻⓗ࡟ࡶᅔ㞴࡛࠶ࡾࠊࡋࡓࡀࡗ࡚ᮏヨ㦂ࢆࡀࢇཎᛶヨ㦂࡟⨨ࡁ᥮࠼ࡿࡇ࡜ࡣ⌧≧࡛ࡣ୙㐺ษ࡛࠶ࡿࠋᮏヨ㦂ࡢ⾜ᨻୖࡢ฼⏝࡟࠶ࡓࡗ࡚ࡣࠊᵓ㐀άᛶ┦㛵࡞࡝࡜⤌ࡳྜࢃࡏ࡚⿵ຓⓗ࡞ヨ㦂ࠊ౛࠼ࡤ WoE ࡟ᇶ࡙ࡃホ౯ࡢ㝿ࡢ୍ࡘࡢ㡯┠ࠊ࠶ࡿ࠸ࡣࡀࢇཎᛶヨ㦂ᐇ᪋ࡢඃඛ㡰఩௜ࡅࡢࡓࡵࡢࢫࢡ࣮ࣜࢽࣥࢢヨ㦂࡜ࡋ࡚఩⨨௜ࡅࡓୖ࡛౑⏝ࡉࢀࡿ࡭ࡁ࡛࠶ࡿࠋཧ⪃ᩥ⊩1)

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Transformation Assay - Prevalidation study Report.

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ECVAM - The Validation Management Team (2010). Syrian Hamster Embryonic (SHE) cell pH 7.0 Cell
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Assay, Series on Testing & Assessment, No 214, ENV/JM/MONO (2015)18.

9)JaCVAM ᙧ㉁㌿᥮ヨ㦂㈨ᩱ⦅⧩ጤဨ఍㸸SHE ⣽⬊ᙧ㉁㌿᥮ヨ㦂ἲ㸦SHE CTA㸧ホ౯ሗ࿌᭩㸦2017ᖺ 3 ᭶ 31 ᪥㸧㸬10) Pienta RJ et al. (1977). Morphological transformation of early passage Golden Syrian Hamster embryo cells
derived from cryopreserved primary cultures as a reliable in vitro bioassay for identifying diversecarcinogens. Int. J. Cancer, 19, 642-655.
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