3 光毒性第三者評価報告書100924改

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3 in vivo 24 in vivo GLP 1 b 4 Acridine BMDM 4-t-butyl-4-methoxydibenzoylmethane CHD Chlorhexidine Bithionol CHD Bithionol in vivo in vivo b in vivo 70% b 5 in vitro 3T3-NRU T3-NRU 3T3 NRU 2 3

4 1. In vitro 3T3 3T3-NRU OECD 3T3-NRU 14 3T3-NRU DMSO Dimethyl sulfoxide 1% DMSO 4

5 % DMSO 6 UVA ( A ) Vilber Lourmat UVB ( B ) Metal halide lamp Dr. Honle GmbH Dr. Honle GmbH SOL500 Dr. Honle GmbH UVB H1 Dr. Honle GmbH UVA Dr. Honle GmbH Z; mm 8-MOP 8 5mm 2mm 5mm 8.5J/cm 2 20J/cm 2 8-MOP 0.01% 0.1 mg/ml 0.1% ( 1 mg/ml ) 5 Bithionol 6-MC (6-metheylcoumarin SLS Sodium lauryl sulfate 3 5

6 5mm 3 4mm DMSO 10%(w/v) 5 4 (100% ) (0%) 5 (100%) (100%) (0%) (0%) Vilber Lourmat SOL500 Dr.Honle (UVB) H1 (UVA-Meter, Dr.Honle ) 6.2 J/cm 2 540nm 2 2 ( ) 540nm 525nm L;% [100 X (OD OD ) (OD OD )] [100 X (OD OD ) (OD OD )] L 5 5 L L 3. 1) Musk ambrette Musk ketone, Musk xylene Phantolid Galaxolide 8-methoxypsoralen (8-MOP) 6

7 5-methoxypsoralen (5-MOP) 6-metheylcoumarin 6-MC 2) Parsol 1789, Parsol MCX ASL-24 ASL-24S Escalol 507(D) 3) Sulfanilamide Indomethacin Piroxicam Chlorpromazine (CPZ) 4) TCC Bithionol TBS TCSA 5) Rose bengal Acridine Anthracene TCSA 8-MOP DNA 5-MOP Musk ambrette, Bithionol, 6-MC sulfanilamide UVB Piroxicam Chlorpromazine Indomethacin EU/COLIPA in vivo 9 1) Anthracene 2) 4-t-butyl-4-methoxydibenzoylmethane (BMDM) 3) Amiodaron, Chlorpromazine (CPZ) 4) Bithionol, Chlorhexidine (CHD) 5) Acridine 6-methylcoumarin (6-MC) 6) Sodium lauryl sulfate (SLS) BMDM Parsol 1789 Parsol 1789 CHD SLS 7

8 4. in vivo in vivo 1) TCSA,8-MOP, 5-MOP, Phantolid, Galaxolide, Acridine, Anthracene 2) Musk ambrette, Musk ketone, Musk xylene, 6-metheylcoumarin, Sulfanilamide, Piroxicam, Chlorpromazine, TCC, Bithionol, TBS 3) Parsol 1789, Parsol MCX, ASL-24, ASL-24S, Escalol 507(D), Indomethacin, Rose bengal (+) TCSA 8-MOP 5-MOP Phantolid Galaxolide Acridine Anthracene Chlorpromazine Chlorpromazine 1) (-) TCC Sulfanilamide Indomethacin Piroxicam Parsol 1789 Parsol MCX ASL-24 ASL-24S Escalol 507(D) Musk ambrette Musk ketone Musk xylene Chloropromazine Sulfanilamide Piroxicam Musk in vivo in vivo 1) Acridine, Amidaron Anthracene 2) Bithionol, CPZ 6-MC 3) BMDM 4) CHD SLS b (+) Acridine Amidaron Anthracene CPZ (-) Bithionol 6-MC BMDM CHD SLS 1) 2) 1 2 3) 4) Bithionol 6-MC 8

9 ( ) R&D EU/COLIPA in vivo in vivo (P) (N) (E)

10 5.2.2 a in vivo Bithionol in vivo CHD b in vivo Amiodaron CPZ in vivo Anthracene c d in vivo Anthracene d in vivo Amiodaron Acridine e f e in vivo CPZ Acridine f CPZ Acridine a f b c e 2 <2mm: Negative, 2mm<diameter<5mm: Equivocal, >5mm: Positive nm 2 3 a b c 2 d e f In vivo Amiodaron b a c d in vivo CHD Bithionol b SLS c 6-MC 3 525nm ) 10 <5%: Negative, 5%<hemolysis<10%: Equivocal, >10%: Positive

11 540nm 525nm Anthracene a b e CPZ nm ) <5%: Negative, 5%<hemolysis<10%: Equivocal, >10%: Positive b c b b 11

12 Acridine BMDM CHD Bithionol CHD Bithonol in vivo 7 in vivo b 70% 64% 12

13 8 in vivo in vivo 9 b in vivo 13

14 nm 525nm 525 nm 10 in vivo MOP Rose bengal d f 1 14

15 c d f 2 (++)

16 SLS 6-MC in vivo SLS f 6-MC c 15 16

17 3 4 2 CHD Bithionol C % 3 4 in vivo in vitro 100% b 4 Acridine BMDM CHD Bithionol b in vivo 70% 6.1 ( ) UVA SOL500 Dr. Honle 17

18 UVB 8.5/cm 2 20J/cm mm 2mm 5mm 5mm 8-MOP 0.1 mg/ml 1mg/mL mg/ml nm 525nm 525nm 540nm 18

19 7. in vivo % 47% 70% 9 in vivo 3T3-NRU GLP GLP GLP GLP GLP GLP

20 GLP GLP GLP GLP GLP GLP GLP GLP ) GLP 2 20

21 A Strategic Approach for Predicting Phototoxicity of Cosmetic Ingredients Altern. Animal Test. Experiment., 9(1), (2002) 3T3-NRU in vivo in vivo T3 NR 3T3-NRU Evaluation of in vitro methods in terms of five parameters 18 Evaluation of the three battery systems 21

22 9.2 Effects of Light Sources on the Prediction of Phototoxicity by the Yeast Growth Inhibition Phototoxicity Assay and the Red Blood Cell Photohemolysis Assay Altern. Animal Test. Experiment., 10(1), 1-17 (2004) 24 solar simulator UVA Availability of the battery system in terms of correlation parameters. Solar simulator 3T3-NRU 3T3-NRU EU/COLIPA 2 3T3-NRU 20 Comparison of correlation parameters for the YGI PT assay, the RBC PH assay and the battery system with the use of the solar simulator Rs 3 2mL 22

23 OECD Guidance for Testing of Chemicals: 432, In vitro 3T3 NRU Phototoxicity Test, OECD/OCED., 13 April 2004 Balb/c 3T3 Neutral red Altern. Animal Test. Experiment., 10(2), (2004) Sugiyama M. et al., A Strategic Approach for Predicting Phototoxicity of Cosmetic Ingredients. Altern. Animal Test. Experiment., 9(1), (2002) Mori M. et al., Effects of Light Sources on the Prediction of Phototoxicity by the Yeast Growth Inhibition Phototoxicity Assay and the Red Blood Cell Photohemolysis Assay. Altern. Animal Test. Experiment., 10(1), 1-17 (2004) 23

24 9 3T3-NRU 2

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3 光毒性第三者評価報告書100924改

3 光毒性第三者評価報告書100924改 評価報告書 酵母光生育阻害試験と赤血球光溶血性試験の 組み合わせによる光毒性試験代替法 平成 22 年 1 月 国立医薬品食品衛生研究所 15 11 25 18 12 6 15 11 25 1 2 3 4 21 5 13 22 5 17 1 2 in vivo 24 in vivo 9 6 6 GLP 1 b 4 Acridine BMDM 4-t-butyl-4-methoxydibenzoylmethane

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