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薬生薬審発0613 平成29年6月 13日 - NIHS

0613 . 29 13 .. 25 303 .. 3T3 Neutral Red Uptake cytotoxicity assay 3T3 NRU OECD GD 129 LD50 . JaCVAM .. in vitro .. OECD TG 430 in vitro TER . OECD TG 431 in vitro 1 .. OECD TG 439 in vitro .. OECD TG 437 2. OECD TG 438 3. OECD TG 460 4. OECD TG 491 5. 1 EpiSkin EpiDerm SkinEthics . epiCS Vitrolife-Skin TG . JaCVAM . 2 ) ii .. Bovine Corneal Opacity and Permeability Test BCOP . 3 ) ii . Isolated Chicken Eye Test ICE . 4 . Fluorescein Leakage Test Method for Identifying Ocular Corrosives and Severe Irritants FL . 5 ) ii . in vitro Short Time Exposure Assay for Eye Irritation Testing STE .. 29 .. LD50 50mg/kg . LD50 50mg/kg 300mg/kg . LD50 200mg/kg . LD50 200mg/kg 1,000mg/kg . LC50 500ppm(4hr) . LC50 500ppm(4hr) 2,500ppm(4hr) . LC50 (4hr) . ) LC50 (4hr) 10mg/ (4hr) . LC50 (4hr) . ( ) LC50 (4hr) (4hr) .. 4 3 1 .. Draize 1 .. 21 .. 3 2 24 48 . 72 3 .. in vitro .. LD50,LC50 10 .. 2,000mg/kg .. 10 5 5 .. ( ) .. 10 100 %. LD50=300mg/kg 10.

・OECD TG 431(in vitro 皮膚腐食性:ヒト3次元培養表皮モデル*1) ただし、皮膚刺激性については、上記腐食性の2試験は用いるこ とができないため、動物実験の代替法として再現度を上げるならば OECD TG 439(in vitro皮膚刺激性試験)の実施も考慮することが

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Transcription of 薬生薬審発0613 平成29年6月 13日 - NIHS

1 0613 . 29 13 .. 25 303 .. 3T3 Neutral Red Uptake cytotoxicity assay 3T3 NRU OECD GD 129 LD50 . JaCVAM .. in vitro .. OECD TG 430 in vitro TER . OECD TG 431 in vitro 1 .. OECD TG 439 in vitro .. OECD TG 437 2. OECD TG 438 3. OECD TG 460 4. OECD TG 491 5. 1 EpiSkin EpiDerm SkinEthics . epiCS Vitrolife-Skin TG . JaCVAM . 2 ) ii .. Bovine Corneal Opacity and Permeability Test BCOP . 3 ) ii . Isolated Chicken Eye Test ICE . 4 . Fluorescein Leakage Test Method for Identifying Ocular Corrosives and Severe Irritants FL . 5 ) ii . in vitro Short Time Exposure Assay for Eye Irritation Testing STE .. 29 .. LD50 50mg/kg . LD50 50mg/kg 300mg/kg . LD50 200mg/kg . LD50 200mg/kg 1,000mg/kg . LC50 500ppm(4hr) . LC50 500ppm(4hr) 2,500ppm(4hr) . LC50 (4hr) . ) LC50 (4hr) 10mg/ (4hr) . LC50 (4hr) . ( ) LC50 (4hr) (4hr) .. 4 3 1 .. Draize 1 .. 21 .. 3 2 24 48 . 72 3 .. in vitro .. LD50,LC50 10 .. 2,000mg/kg .. 10 5 5 .. ( ) .. 10 100 %. LD50=300mg/kg 10.

2 ( ) 3 3 . pH2 pH11 5. 1 .. TG 430,TG 431 TG 439 .. TG 437, TG 438, TG 460, TG 491 . in vitro TG[ ] . OECD No.[ ] .. ( ) .. GHS . LD50 1,000mg/kg . LD50 2,000mg/kg.


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