⌒ೝỗᕈઍᦧᴺ ᡷ⸓ OECD TG No.437 ‐៰಴ⷺ⤑ߩᷙỘ߅ࠃ߮ㅘㆊᕈ⹜㛎ᴺ
㧔BCOP ᴺ㧦Bovine Corneal Opacity and Permeability Test㧕ߩ⹏ଔႎ๔ᦠ

ᐔᚑ 25 ᐕ 7 ᦬ 19 ᣣ

15⌒ೝỗᕈઍᦧᴺ⹏ଔᆔຬળᆔຬฬ㧦┻ౝ ዊ⧣ 㧔P&G ࠗࡁࡌ࡯࡚ࠪࡦวหળ␠㧕ዊဈ ᔘม 㧔ᱷ⇐ㄘ⮎⎇ⓥᚲ㧕ട⮮ 㓷৻ 㧔ᩣᑼળ␠ࠫࡖࡄࡦ࡮࠹ࠖ࠶ࠪࡘ࡮ࠛࡦࠫ࠾ࠕ࡝ࡦࠣ㧕☄ౝ ᩶ሶ 㧔࿖┙ක⮎ຠ㘩ຠⴡ↢⎇ⓥᚲ㧕⚦੗ ৻ᒄ 㧔ෳᄤ⵾⮎ᩣᑼળ␠㧕Ⴧ↰ శノጊᧄ ⋥᮸ 㧔⮮↰଻ஜⴡ↢ᄢቇ㧕ศ᧛ ഞ 㧔᧲੩ℂ⑼ᄢቇฬ⹷ᢎ᝼㧕

26⇛⺆
BCOP:

Bovine Corneal Opacity and Permeability Test

BRD:

Background Review Document

DSD:

Dangerous Substances Directive

EPA:

Environmental Protection Agency

EU:

European Union

GHS:

Globally Harmonized Systems of Classification and Labeling

ICCVAM: Interagency Coordinating Committee on the Validation of AlternativeMethods
IVIS:

In Vitro Irritancy Score

NICEATM: NTP Interagency Center for the Evaluation of Alternative ToxicologicalMethods
OECD:Organization for Economic Co-operation and Development

UN:United Nations

US:United States

37㧝㧚ᡷ⸓ߩ⢛᥊‐៰಴ⷺ⤑ߩᷙỘ߅ࠃ߮ㅘㆊᕈ⹜㛎ᴺ㧔Bovine Corneal Opacity and Permeability Test;એਅ‫ޔ‬BCOP ᴺ㧕ߪ‫ ߚ޿↪ࠍࠡࠨ࠙ޔ‬Draize ⌒ೝỗᕈ⹜㛎ᴺ㧔એਅ‫ޔ‬Draize ᴺ㧕ߩઍᦧ⹜㛎ᴺߢ޽ࠆ‫ޕ‬2003 ᐕ߆ࠄ 2006 ᐕߩ NICEATM㧔NTP Interagency Center for theEvaluation of Alternative Toxicological Methods㧕/ICCVAM 㧔Interagency CoordinatingCommittee on the Validation of Alternative Methods㧕ߦࠃࠆ࿁㘈⊛ߥࡃ࡝࠺࡯࡚ࠪࡦࠍ⚻ߡ‫ࠆߌ߅ߦ࠴࡯ࡠࡊࠕࡦ࠙࠳ࡊ࠶࠻ޔ‬㊀◊ߥ⌒ߩ்ኂࠍ⿠ߎߔൻቇ‛⾰㨇UN㧔UnitedNations㧕 GHS㧔Globally Harmonized Systems of Classification and Labeling㧕඙ಽ 1‫ޔ‬US㧔United States㧕 EPA㧔Environmental Protection Agency㧕඙ಽ 1‫ޔ‬EU㧔EuropeanUnion㧕 DSD㧔Dangerous Substances Directive㧕 R43㨉ࠍหቯߔࠆߚ߼ߩ⹜㛎ᴺߣߒߡ
2009 ᐕߦ OECD㧔Organization for Economic Co-operation and Development㧕࠹ࠬ࠻ࠟࠗ࠼࡜ࠗࡦ㧔TG㧕No.437 ߣߒߡណᛯߐࠇߚ‫ޕ‬ߐࠄߦ‫ޔ‬2006 ᐕ߆ࠄ 2009 ᐕߦ߆ߌ‫ࠆߌ߅ߦ࠴࡯ࡠࡊࠕࡊ࠶ࠕࡓ࠻ࡏޔ‬㊀◊ߥ⌒ߩ்ኂࠍ⿠ߎߔ‛⾰߅ࠃ߮⌒ೝỗᕈ‛⾰ߣߪಽ㘃ߐࠇߥ޿‛⾰㧔એਅ‫ޔ‬඙ಽᄖ‛⾰㧕ߩหቯᴺߣߒߡߩㆡ↪ᕈߦߟ޿ߡ‫ޔ‬࿁㘈⊛ߥࡃ࡝࠺࡯࡚ࠪࡦ߇ⴕࠊࠇߚ‫⚿ߩߘޕ‬ᨐ‫ޔ‬2009 ᐕ‫ޔ‬NICEATM/ICCVAM ߩ╙ਃ⠪⹏ଔᆔຬળߢ‫ޔ‬UN GHS ߅ࠃ߮ EU DSD ߩಽ㘃ߦ߅ߌࠆ඙ಽᄖ‛⾰ࠍหቯߔࠆᣇᴺߣߒߡ᦭↪ߢ޽ࠆߣ޿߁⚿⺰ࠍᓧߚ‫⚿ߩߎޕ‬ᨐࠍฃߌ‫ޔ‬OECD ߢߪ BCOP ᴺࠍ㊀◊ߥ⌒ߩ்ኂࠍ⿠ߎߔൻቇ‛⾰ߛߌߢߥߊ‫ޔ‬඙ಽᄖ‛⾰ߩหቯᣇᴺߣߒߡ↪޿ࠆߎߣࠍᬌ⸛ߔࠆߚ߼‫ޔ‬TG No.437 ߩᡷ⸓ᬌ⸛ࡊࡠࠫࠚࠢ࠻߇ߚߜ޽ߍࠄࠇߚ‫ߩߎޕ‬ࡊࡠࠫࠚࠢ࠻ߢ⚵❱ߐࠇߚ⌒ೝỗᕈኾ㐷ኅળ⼏ߦ߅޿ߡ‫߼ߚߩ࠴࡯ࡠࡊࠕࡦ࠙࠳ࡊ࠶࠻ޔ‬ߩ BRD㧔Background Review Document㧕ߦᣂߚߥ࠺࡯࠲ࠍㅊടߒߚ Issue Paper ߦၮߠ޿ߡ‫ޔ‬BCOP ᴺߩࡏ࠻ࡓࠕ࠶ࡊࠕࡊࡠ࡯࠴ߢߩᕈ⢻߇ᬌ⸛ߐࠇߚ‫⚿ߩߘޕ‬ᨐ‫ޔ‬2013 ᐕ‫ޔ‬BCOPᴺ߇ࡏ࠻ࡓࠕ࠶ࡊࠕࡊࡠ࡯࠴ߢߩ඙ಽᄖ‛⾰ߩหቯᴺߣߒߡᱜᑼߦᡷቯ TG No.437 ߦណᛯߐࠇߚ‫ޔ߈ߣߩߎޕ‬ㆡ↪㒢⇇ߣ㓁ᕈኻᾖ‛⾰╬ߦߟ޿ߡߩᡷ⸓߽หᤨߦⴕࠊࠇߚ‫ߩߎޕ‬ࠃ߁ߦߒߡߢ߈ߚߩ߇ᡷቯ TG No.437 ߢ޽ࠆ‫⹏ᧄޕ‬ଔᆔຬળߪ‫ߩߎޔ‬ᡷቯ TG No.437ߩᅷᒰᕈࠍᬌ⸛ߒߚ‫ޕ‬એਅߦߘߩᬌ⸛⚿ᨐࠍႎ๔ߔࠆ‫ޕ‬㧞㧚⹜㛎ߩ᭎ⷐ
BCOP ᴺߪ‫៰ࠄ߆⃿⌒‐ޔ‬಴ߒߚⷺ⤑ߦⵍ㛎‛⾰ࠍ৻ቯᤨ㑆ᦑ㔺ߐߖ‫ߩ⤑ⷺޔ‬ᄌᕈߩᜰᮡߣߥࠆⷺ⤑ᷙỘᐲߣⷺ⤑਄⊹ߩࡃ࡝ࠕᯏ⢻ߩᜰᮡߣߥࠆⷺ⤑ㅘㆊᐲࠍ᷹ቯߒ‫ࠄࠇߘޔ‬᷹ቯ୯߆ࠄ⸘▚ᑼߦࠃߞߡ᳞߼ࠄࠇࠆ IVIS㧔In Vitro Irritancy Score 㧦in vitro ೝỗᕈࠬࠦࠕ㧕ࠍၮߦ࠙ࠨࠡࠍ↪޿ߚ Draize ᴺߢߩ⌒ೝỗᕈࠍ੍᷹ߔࠆઍᦧ⌒ೝỗᕈ⹜㛎ᴺߢ޽ࠆ‫ޕ‬⹜㛎⟲޽ߚࠅ 3 ୘ߩⷺ⤑ࠍ૶↪ߒ‫ⵍޔ‬㛎‛⾰߇ᶧ૕ߩ႐วߪේᶧ㧔100%‫⇇ߒߛߚޔ‬㕙ᵴᕈ೷ߩ႐วߪ 10%Ꮧ㉼ᶧ㧕ࠍ‫ޔ‬࿕૕ߩ႐วߪ 20%ߩṁᶧ߹ߚߪ Ộᶧࠍ‫ ࠇߙࠇߘޔ‬10 ಽ㑆‫ ߪߚ߹ޔ‬4 ᤨ㑆ᦑ㔺ߐߖࠆ‫ߩߘޕ‬ᓟ‫ޔ‬ᷙỘᐲߣߒߡࠝࡄࠪ࠻ࡔ࡯࠲ߢⷺ⤑ߩశㅘㆊᐲࠍ‫ޔ‬߹ߚ‫ޔ‬ㅘㆊᐲߣߒߡࡈ࡞ࠝ࡟࠮ࠗࡦ࠽࠻࡝࠙ࡓߩㅘㆊᐲ㧔OD490㧕ࠍ᷹ቯߔࠆ‫ ࠄࠇߎޕ‬2 ߟ48ߩ᷹ቯ୯ࠍએਅߩ⸘▚ᑼߦᒰߡߪ߼ IVIS ୯ࠍ▚಴ߔࠆ‫ޕ‬ 㧔⸘▚ᑼ㧕IVIS = mean opacity + (15 x mean OD490)
IVIS ߩ୯߇ 3 એਅߩ႐ว‫ⵍߩߘޔ‬㛎‛⾰ߪ GHS ඙ಽᄖ‛⾰ߣ್ᢿߐࠇ㧔ㅊടߐࠇߚၮḰ㧕‫ޔ‬IVIS ߩ୯߇ 55 ࠍ⿥߃ࠆ႐วߪ඙ಽ㧝ߣ್ᢿߐࠇࠆ‫ޕ‬IVIS ߩ୯߇ 3 < IVIS < 55 ߩ႐ว‫⹜ᧄޔ‬㛎ᴺߩ⚿ᨐߩߺߢߪ⌒ೝỗᕈߩ੍᷹ߪߢ߈ߥ޿ߚ߼‫ޔ‬ㅊടߩ⹜㛎ࠍᔅⷐߣߔࠆ‫ޕ‬㧟㧚ᡷ⸓ὐ㧟㧙㧝㧚ࡏ࠻ࡓࠕ࠶ࡊࠕࡊࡠ࡯࠴ߢߩ GHS ඙ಽᄖ‛⾰ߩหቯ㧟㧙㧝㧙㧝㧚 ࡏ࠻ࡓࠕ࠶ࡊࠕࡊࡠ࡯࠴ߢߩᱜ⏕ᕈ೨࿁⹏ଔࠍⴕߞߚ ICCVAM ߩࡃ࡝࠺࡯࡚ࠪࡦ࠺࡯࠲ࡌ࡯ࠬߦ 66 ߩ᛫⩶ᵞᵺ⵾ຠߩ⚿ᨐࠍᣂߚߦㅊടߒߚ࠺࡯࠲ࡌ࡯ࠬࠍ↪޿ߚᱜ⏕ᕈ⹏ଔߩ⚿ᨐࠍ⴫ 1 ߦ␜ߔ‫ޕ‬⴫ 1㧚BCOP ᴺߩᱜ⏕ᕈ㧙GHS ಽ㘃ᴺߢߩ඙ಽᄖ‛⾰ߩหቯ59඙ಽᄖ‛⾰ߩหቯߦ߅޿ߡ‫ޔ‬Draize ᴺߩ⚿ᨐࠍᲧセኻᾖߦߔࠆߣ‫ޔ‬BCOP ᴺߩᱜ⏕ᐲߪ
69%㧔135/196㧕‫ޔ‬ன㓁ᕈ₸ 69%㧔61/89㧕‫ޔ‬ன㒶ᕈ₸ 0%㧔0/107㧕ߣߥߞߚ‫ޕ‬ன㓁ᕈ₸ߪ㜞޿߇‫ߪߢ࠴࡯ࡠࡊࠕࡊ࠶ࠕࡓ࠻ࡏޔ‬㓁ᕈ⚿ᨐ߇ᓧࠄࠇߚ႐ว‫ߜࠊߥߔޔ‬඙ಽᄖ‛⾰ߣ್ቯߐࠇߥ߆ߞߚ႐วߪ‫ߩઁޔ‬ᣇᴺߦࠃࠆㅊട⹜㛎߇ᔅⷐߣߥࠆߎߣ߆ࠄ‫ޔ‬ன㓁ᕈ₸߇㜞޿ߎߣߪᔅߕߒ߽໧㗴ߦߪߥࠄߥ޿ߣ್ᢿߒߚ‫ޕ‬㧟㧙㧝㧙㧞㧚ࡏ࠻ࡓࠕ࠶ࡊࠕࡊࡠ࡯࠴ߢߩᣉ⸳ౝ࡮ᣉ⸳㑆ౣ⃻ᕈ
BCOP ᴺߩ IVIS ୯ߩᣉ⸳ౝౣ⃻ᕈߪචಽߢ޽ࠆߣ޿߁್ᢿߪ೨࿁ߩ⹏ଔߢߐࠇߡ޿ࠆ‫ޕ‬ࡏ࠻ࡓࠕ࠶ࡊࠕࡊࡠ࡯࠴ߦ߅ߌࠆ඙ಽᄖ‛⾰ࠍหቯߔࠆ႐วߩᣉ⸳㑆ౣ⃻ᕈߦߟ޿ߡ‫ޔ‬3ߟߩࡃ࡝࠺࡯࡚ࠪࡦ⹜㛎ߩ⚿ᨐࠍ⴫ 2 ߦ␜ߔ‫⚿ߩߘޕ‬ᨐ‫ޔ‬80%㧔103/128㧕ߩ‛⾰ߦ߅޿ߡ‫ޔ‬ߘࠇߙࠇߩ⹜㛎ෳടᣉ⸳ߔߴߡߩ್ቯ߇ 100%৻⥌ߒߚ‫ߩߢ࠴࡯ࡠࡊࠕࡊ࠶ࠕࡓ࠻ࡏޕ‬ᣉ⸳㑆ౣ⃻ᕈߪචಽߢ޽ࠆߣ್ᢿߒߚ‫ޕ‬⴫ 2㧚BCOP ᴺߩᣉ⸳㑆ౣ⃻ᕈ㧙GHS ಽ㘃ᴺߢߩ඙ಽᄖ‛⾰ߩหቯ́ICCVAM(2010)ࠃࠅᛮ☴Data Source
Balls et al. (1995)
Gautheron et al. (1994)

No. ofTesting Labs

No. ofSubstances

Substances with 100%
Agreement among Labs

56055 (92%)

5234 (65%)

1112Southee (1998)

31614 (88%)

Total-128

103 (80%)㧟㧙㧞㧚࠻࠶ࡊ࠳࠙ࡦࠕࡊࡠ࡯࠴ߢߩ GHS ඙ಽ㧝㧔㊀◊ߥ⌒ߩ்ኂࠍ⿠ߎߔൻቇ‛⾰㧕ߩหቯ࠻࠶ࡊ࠳࠙ࡦࠕࡊࡠ࡯࠴ߦ߅ߌࠆ㊀◊ߥ⌒ߩ்ኂࠍ⿠ߎߔൻቇ‛⾰㧔඙ಽ 1㧕ࠍหቯߔࠆ႐วߩᱜ⏕ᕈߦߟ޿ߡ߽‫ޔ‬ᣂߚߥࡃ࡝࠺࡯࡚ࠪࡦ࠺࡯࠲ࡌ࡯ࠬߢߩ⚿ᨐࠍ⴫ 3 ߦ␜ߔ‫ߎޕ‬ࠇߦࠃࠆߣ‫ޔ‬ᱜ⏕ᐲ‫ޔ‬ன㓁ᕈ₸‫ޔ‬ன㒶ᕈ₸ߣ߽‫ޔ‬೨࿁⹏ଔߩ⚿ᨐ߇ᄌࠊࠆ߶ߤߩᄢ߈ߥ㆑޿ߪߥ޿‫ޕ‬ߥ߅‫ߩ࠴࡯ࡠࡊࠕࡦ࠙࠳ࡊ࠶࠻ޔ‬ᣉ⸳ౝ࡮ᣉ⸳㑆ౣ⃻ᕈߪචಽߢ޽ࠆߣ೨ႎߦߡ್ᢿߒߚ‫ޕ‬610⴫ 3㧚BCOP ᴺߩᱜ⏕ᕈ㧙GHS ಽ㘃ᴺߢߩ඙ಽ 1 ‛⾰ߩหቯ㧟㧙㧟㧚ㆡ↪㒢⇇ࠕ࡞ࠦ࡯࡞࡮ࠤ࠻ࡦ㘃߅ࠃ߮࿕૕‛⾰ߩㆡ↪ߦߟ޿ߡߪ೨࿁ߩ࠻࠶ࡊ࠳࠙ࡦࠕࡊࡠ࡯࠴ߩ⹏ଔߢߪᧄ⹜㛎ᴺߩ㒢⇇ߣߒߡ᜼ߍࠄࠇߡ޿ߚ߇‫ޔ‬એਅߩℂ↱߆ࠄࠕ࡞ࠦ࡯࡞࡮ࠤ࠻ࡦ
㘃߅ࠃ߮࿕૕‛⾰߽ㆡ↪ߔࠆߎߣ߇ߢ߈ࠆߣ್ᢿߒߚ‫ޕ‬y㊀◊ߥ⌒ߩ்ኂࠍ⿠ߎߔൻቇ‛⾰ࠍหቯߔࠆߩߦ↪޿ࠆ႐ว㧔࠻࠶ࡊ࠳࠙ࡦࠕࡊࡠ࡯࠴㧕‫ߚࠇࠄ޿↪ߦࡦ࡚ࠪ࡯࠺࡝ࡃޔ‬ൻቇ‛⾰ߩ࠺࡯࠲ࡌ࡯ࠬߩਛߢ‫ࠤ࡮࡞࡯ࠦ࡞ࠕޔ‬࠻ࡦ㘃ߦኻߒ㜞޿ன㓁ᕈ₸‫ޔ‬࿕૕‛⾰ߦኻߒ㜞޿ன㒶ᕈ₸ࠍ␜ߒߚ‫ࠄࠇߎޔߛߚޕ‬ൻቇ‛⾰㘃ߩਛߢ߽ᱜ⏕ߦ੍᷹ߐࠇߚ߽ߩߪ޽ࠆ‫ޔߚ߹ޕ‬ன㒶ᕈߩ⚿ᨐࠍ␜ߒߚ࿕૕‛⾰ߪߔߴߡ 3 < IVIS < 55㧔⌒ೝỗᕈ੍᷹ਇน㧕ߣߥࠅ‫⚿ޔ‬ᨐߣߒߡ೎ߩ⹜㛎ᴺߢߩᬌ⸛߇ᔅⷐߣߐࠇࠆ‫ࡦ࠻ࠤ࡮࡞࡯ࠦ࡞ࠕޕ‬㘃ߢ㓁ᕈ⚿ᨐ߇ᓧࠄࠇߚ႐วߪ‫ޔ‬㜞޿ன㓁ᕈ₸ࠍ⠨ᘦߒ‫⚿ߩߘޔ‬ᨐߪᘕ㊀ߦᬌ⸛ߔࠆᔅⷐ߇޽ࠆ‫ࠄࠇߎޔߪߡߒߣ⺰⚿ޕ‬ൻቇ‛⾰㘃ࠍ‫ޔ‬ㆡ↪㗔ၞ߆ࠄ㒰ᄖߔࠆᔅⷐߪߥ޿ߣ್ᢿߐࠇߚ‫ޕ‬඙ಽᄖ‛⾰ࠍหቯߔࠆߩߦ↪޿ࠆ႐ว㧔ࡏ࠻ࡓࠕ࠶ࡊࠕࡊࡠ࡯࠴㧕‫ޔ‬㜞޿ன㓁ᕈ₸ࠍ␜ߒߚ‫ޔࠄ߇ߥߒ߆ߒޕ‬3 <IVIS < 55㧔⌒ೝỗᕈ੍᷹ਇน㧕ߣߥߞߚ‛⾰ߪㅊട⹜㛎ߦࠃࠆಽ㘃್ᢿ߇ᔅⷐߣߥࠆߎߣ߆ࠄ‫ޔ‬ᔅߕߒ߽໧㗴ߪߥࠄߥ޿ߣ್ᢿߒߚ‫ߩ࠴࡯ࡠࡊࠕࡦ࠙࠳ࡊ࠶࠻ޕ‬႐วߣ⇣ߥࠅ‫ࡦ࠻ࠤ࡮࡞࡯ࠦ࡞ࠕޔߪߢ࠴࡯ࡠࡊࠕࡊ࠶ࠕࡓ࠻ࡏޔ‬㘃‫ޔ‬࿕૕‛⾰ߩ⚿ᨐ߇ᱜ

711⏕ᕈߦᓇ㗀ࠍਈ߃ߡߪ޿ߥ޿‫ޕ‬߹ߚ‫⹜ࡦ࡚ࠪ࡯࠺࡝ࡃޔ‬㛎ߢߪන৻‛⾰࡮ᷙว‛⾰߇ߘࠇߙࠇ 113 ‛⾰‫ޔ‬100 ‛⾰ߣචಽߥᢙ߇⹏ଔߐࠇߡ߅ࠅ‫߽ࠄߜߤޔ‬ㆡ↪น⢻ߢ޽ࠆߣ್ᢿߐࠇߡ޿ࠆ‫ޕ‬㧟㧙㧠㧚 㓁ᕈኻᾖ2009 ᐕߦᧄ⹏ଔᆔຬળ߇⹏ଔߒߚ BCOP ᴺߪᶧ૕ⵍ㛎‛⾰ߩ㓁ᕈኻᾖߣߒߡ 100%ࠛ࠲ࡁ࡯࡞ࠍ↪޿ߡ޿ߚ߇‫ޔ‬OECD ࠟࠗ࠼࡜ࠗࡦൻߩᤨὐߢ 100%ࠛ࠲ࡁ࡯࡞ߦᦧࠊࠅ 1%᳓㉄ൻ࠽࠻࡝࠙ࡓ߇ណ↪ߐࠇߡ޿ߚ‫ޕ‬੹࿁ߩᡷ⸓ TG No.437 ߢߪ㓁ᕈኻᾖߦߟ޿ߡએਅߩ᧦ઙ߇ᔅⷐߣߐࠇߚ‫ޔߜࠊߥߔޕ‬หߓ⹜㛎♽ߢ㓁ᕈ෻ᔕࠍ⺃⊒ߔࠆߎߣ߇ᣢ⍮ߢ޽ࠆߎߣߣ‫ޔ‬෻ᔕߩᄌേࠍ⹏ଔߔࠆߚ߼ߦ෻ᔕ߇ㆊᐲߢߥ޿ߎߣߢ޽ࠆ‫ޔࠅࠃߦࠇߎޕ‬1%᳓㉄ൻ࠽࠻࡝࠙ࡓ߇㓁ᕈኻᾖ୥⵬‛⾰࡝ࠬ࠻߆ࠄ㒰ᄖߐࠇ‫ޔ‬100%ࠛ࠲ࡁ࡯࡞߇ߎߩ࡝ࠬ࠻ߦട߃ࠄࠇߚ‫ޕ‬100%ࠛ࠲ࡁ࡯࡞ߪ‫ޔ‬BCOPᴺߢߩ⌒ೝỗᕈಽ㘃߇ Draize ᴺߣ৻⥌ߒߡ޿ߥ޿߇‫ޔ‬ᡷ⸓ TG No.437 ߩ㓁ᕈኻᾖߩᔅⷐ᧦ઙߦߪวߞߡ߅ࠅ‫ޔ‬BCOP ᴺߢߩ⢛᥊࠺࡯࠲߇ᄙߊ޽ࠆߎߣ߆ࠄ‫⹏ᧄޔ‬ଔᆔຬળߪ 100%ࠛ࠲ࡁ࡯࡞ࠍᶧ૕ⵍ㛎‛⾰ߩ㓁ᕈኻᾖ‛⾰ߣߔࠆߎߣߦ໧㗴ߪߥ޿ߣ್ᢿߒߚ‫ޕ‬㧟㧙㧡㧚ߘߩઁ ⹜㛎ណ↪ၮḰߦߟ޿ߡ߽ᡷ⸓߇ߥߐࠇߡ޿ࠆ߇‫ߥ⊛⾰ᧄޔ‬ㇱಽߢߪߥߊ‫ౕޔ‬૕⊛ߥ࠺࡯࠲߽ߥ޿ߎߣ߆ࠄ޽߃ߡ⹏ଔߪታᣉߒߥ߆ߞߚ‫ޕ‬㧠㧚⚿⺰ᧄ⹏ଔᆔຬળߪߘߩᱜ⏕ᕈ‫ޔ‬ౣ⃻ᕈߩ⚿ᨐࠃࠅ‫ޔ‬BCOP ᴺࠍ GHS ߩ⌒ೝỗᕈಽ㘃ߦ߅޿ߡ࠻࠶ࡊ࠳࠙ࡦࠕࡊࡠ࡯࠴ߢߩ㊀◊ߥ⌒ߩ்ኂࠍ⿠ߎߔൻቇ‛⾰ࠍหቯߔࠆߚ߼ߩᣇᴺߛߌߢߥߊ‫⌒ߩߢ࠴࡯ࡠࡊࠕࡊ࠶ࠕࡓ࠻ࡏޔ‬ೝỗᕈ඙ಽᄖ‛⾰ࠍหቯߔࠆᣇᴺߣߒߡ߽↪޿ࠆߎߣ߇น⢻ߢ޽ࠆߣ್ᢿߒߚ‫⹜ᧄޔ߽ߡ޿߅ߦ࠴࡯ࡠࡊࠕߩࠄߜߤޔߚ߹ޕ‬㛎ᴺߩㆡ↪
‛⾰ߦ೙㒢ࠍ⸳ߌࠆᔅⷐߪߥߊ‫ޔ‬ᶧ૕ⵍ㛎‛⾰ߩ㓁ᕈኻᾖߣߒߡ 100%ࠛ࠲ࡁ࡯࡞ࠍ↪޿ࠆߎߣ߇ߢ߈ࠆߣ⠨߃ߚ‫ޕ‬ ⚿⺰ߣߒߡ‫ ࠆߌ߅ߦ࠴࡯ࡠࡊࠕࡦ࠙࠳ࡊ࠶࠻ޔ‬GHS ඙ಽ 1 ‛⾰‫ࠕࡊ࠶ࠕࡓ࠻ࡏ߮ࠃ߅ޔ‬ࡊࡠ࡯࠴ߦ߅ߌࠆ GHS ඙ಽᄖ‛⾰ߩหቯߦ‫ޔ‬Draize ᴺߩઍᦧᴺߣߒߡᡷ⸓ TG No.437 ࠍ↪޿ࠆߎߣߪน⢻ߢ޽ࠆߣ್ᢿߒߚ‫ޕ‬812㧡㧚ᢥ₂y

JaCVAM (2009), ⌒ೝỗᕈ⹜㛎ઍᦧᴺߩ╙ਃ⠪⹏ଔႎ๔ᦠ́⹏ଔኻ⽎⹜㛎㧦⌒ߦኻߔࠆ⣣㘩ᕈ߅ࠃ߮ᒝೝỗᕈ⹏ଔߩߚ߼ߩ‐៰಴ⷺ⤑ߩᷙỘ߅ࠃ߮ㅘㆊᕈ⹜㛎ᴺy

ICCVAM (2010), ICCVAM Test Method Evaluation Report: Current Validation
Status of In Vitro Test Methods Proposed for Identifying Eye Injury Hazard
Potential of Chemicals and Products. NIH Publication No. 10-7553.

yOECD (2009), Bovine Corneal Opacity and Permeability Test Method for
Identifying Ocular Corrosives and Severe Irritants, TG437

yOECD (2013), Updated TG 437 on the BCOP Test Method, ENV/JM/TG(2013)14yOECD (2013), Issue Paper on the Use of the BCOP Test Method to Identify
Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage,EVN/JM/TG(2013)15yOECD (2013), Streamlined Summary Document Supporting OECD Guideline 437
on the Bovine Corneal Opacity and Permeability for Eye Irritation/Corrosion,
ENV/JM/MONO(2013)13

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