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1 3-107-
2
3 LD50 LC50 ATE (mg kg ) a (mg kg ) a (ppm) a b mg a b c d (mg ) a b e f ppmv (a) (ATE) - LD50/LC
4 (b) (c) (d) 1(100ppm) 2(500ppm) 3(2500ppm) 4(5000ppm) ppm : ( ) ; : ( ) ; : 1µm 100µm (e) OECD (f) 5 LD mg kg 5 (i) LD50 (LC50) 5 5 (ii)
5 IOMC CG HCCS LD LD mg kg mg ppm mg ppmv OECD (MMAD) mg/l OECD mg/kg (f)
6 in vitro % %
7 (a) (b) (ATE) (Conversion Value) (mg/kg ) (mg/kg ) (ppmv) (mg/ ) l (mg/ ) ppm mg/kg LD
8 ATE 1/ (Bridging principles) LD mg/kg LD mg/kg A B C A B C A B
9 (a) 2 ( ) A+B ( ) C+B (b) B (c) ( ) A ( ) C (d) A C A C B ( ) (ATE) (a) (b) (c) GHS 2,000mg/kg (ATE) ATE ATE Ci = i i ATEmix = Ci ATEi ATEi= i
10 ATE (a) 2 (b) (c) (d) % x % % % 100 ( C unknown if > 10%) ATEmix = Ci ATEi
11 : : : LD50 5 mg/kg LD mg/kg ( ) LC ppm ( ) LC mg/l ( ) LC mg/l LD 50 >5 <50 mg/kg LD 50 >50 < 200 mg/kg ( ) LC 50 >100 < 500 ppm ( ) LC 50 > 0.5 < 2.0 mg/l ( ) LC 50 > mg/l
12
13 LD 50 >50 < 300 mg/kg LD 50 > 200 < 1000 mg/kg ( ) LC 50 >500 < 2500 ppm ( ) LC 50 >2 < 10.0 mg/l ( ) LC 50 >0.5 < 1.0 mg/l LD 50 >300 < 2000 mg/kg LD 50 >1000 < 2000 mg/kg ( ) LC 50 >2500 < 5000 ppm ( ) LC 50 >10 < 20 mg/l ( ) LC 50 >1 < 5 mg/l LD 50 >2000 < 5000 mg/kg LD 50 >2000 < 5000 mg/kg ( ) LC 50 LD 50 ( mg/kg )
14 ( )
15 3.1.2 ( ) i = ATE mix n Ci= i C ATE i ATE mix n i n ATEi = i 3 ( ATE mix 10 ) ( C unknown if > 10% ) = ATEmix n Ci ATEi
16
17 ( ) ph in vitro in vivo ph
18 a g) a) 1b g) a) 1c 2a b) a) 2b b) a) 3 ph c) ph a) ph 4 d) 5 in vitro e a)
19 in vitro f a) 7 in vitro ( 1 ) a) 8 In vivo 3 h) a) 9 a) g (a) (b) (c) ph (d) in vivo (e) in vitro OECD (f) in vitro (g) OECD (h)
20 ( ) 3 1A 3 1 1B C a 3 1 ( ( ) ) 1A 3 1 1B C a (a) (b) (c) ( ) ( )
21 a (1) ( 2) 72 ( ) (2) 2 14 (3) ( 3) 3 ( ) a
22 ph ph in vitro (Bridging principle) A B C A B C A B
23 (a) 2 ( ) A+B ( ) C+B (b) B (c) ( ) A ( ) C (d) A C A C B ( ) ph %
24 3% % 3% ( ) 5% 5% 1% 10% 10% 1% 10% (10 ) (10 ) 10% 10% 1% 10% 5% 5% 5% 5%
25 3.2.4 ph 2 1% ph % 1% 3% A 1 B 1 C
26 ( 3.2.1, ) In vitro ph ( )
27 (3.2.1, ) In vitro ( )
28 3.2.2 ( ) 4,5 (3.2.1, ) ph ,5 ( )
29 7 5 5% 5 1% < 5% 10% (10 ) + 10% 5 1% < 10% 10% (10 ) + 1% < 10% (10 ) %
30
31 (SAR) (SPR) in vitro in vivo ph ph in vitro in vivo ph
32 Solna a 1b 2 OECD(1996) ENV/MC/TG(96)9(
33 c 2a 2b 2c 3a 3b ph ph 11.5 ph 2 2 ph
34 in vitro 5a in vitro in vitro 6 in vitro in vitro 7 6a In vitro
35 a b 1a - (ii) 1b - 1 2a b c SAR SPR SAR SPR SAR SPR (i) 2a - - (ii) 2c ph 1 4 LD in vitro in vivo
36 Draize (c)
37 ph ph in vitro (Bridging principle)
38 A B C A B C A B (a) 2 ( ) A+B ( ) C+B (b) B (c) ( ) A ( ) C (d) A C ( )
39 ph % 3% % 3% % 3% 1% 10% (10 ) 10% 3% 3% 1% 10 10%
40 3.3.4 ph 2 1% ph % 1% 3% A 2B
41 ( ) 4 In vitro ph
42 In vitro ( )
43 3.3.2 ( ) ( ) ph < 2 > ( ) < 1 %,
44 7 3% 3% 7 1% < 3% 2/2A 10% (10 ) + 2A/2B 10% 1 + 1% < 3% 10 ( 1 + 1) + 2A/2B 10%
45 (a) (b) (a) (i) in vivo (ii) in vitro
46 (iii) (iv) (b) (a) E (IgE) (b) (a) 2 maximisation test
47 (b) (c) (d) (e) (a) (b) (c) (d) (e) % 15% OECD 406 Maximisation Test Buehler
48 OECD (Bridging principle)
49 (a) 2 ( ) A+B ( ) C+B (b) B (c) ( ) A ( ) C (d) B A C (e) A C B ( ) % 1 1.0% 2 0.1% 3 0.1% 5 1.0% 4 0.2% SDS
50 1.0 SDS SDS SDS SDS SDS
51 : : % w/w 0.2% v/v
52 % w/w 1% v/v
53 in vitro in vivo DNA DNA DNA DNA DNA In vitro OECD in vivo (OECD478) (OECD485) in vivo (OECD475) (OECD484) (OECD474)
54 in vivo - in vivo in vivo - in vitro - in vivo - in vitro in vivo - in vitro in vivo (a) (OECD483) (b) (SCE) DNA (UDS) in vivo DNA (UDS) (OECD486) (SCE)
55 In vitro (OECD473) (OECD476) (OECD471) (Bridging principle) (a) 2 ( ) A+B ( ) C+B (b) B
56 (c) ( ) A ( ) C (d) A C A C ( ) % % A 1B
57 GHS
58 % 1.0%
59 in vivo
60
61 ( )
62 (IARC) (a) (b) (c ) (d) (e) (f) (g) (h) (i) (j) (k)
63 in vivo WHO IPCS 1995,Carshalton,UK (Bridging principle)
64 (a) 2 ( ) A+B ( ) C+B (b) B (c) ( ) A ( ) C (d) A C A C B ( ) % % 1 1.0%
65 % 1% SDS 0.1% 1% 2 2 1% SDS A 1B
66
67 , , % 2 0.1% 2 1.0%
68 International Agency for Research on Cancer IARC (a) (b) (a) (b) (c) (i) (ii)1 (i) (ii) (iii) IARC OECD OECD
69 IPCS/EHC (a) (b) / (a) (b) (c) (d)
70 (a)
71 3.7.1(b) (a) (b) (c) B
72
73 %
74 OECD 414 ICH S5A 1993 ICH S5B 1995 OECD OECD In vitro (SAR) OECD
75 OECD 1000mg kg (Bridging principle) (a) 2 ( ) A+B ( ) C+B (b) B (c) ( ) A ( ) C
76 (d) A C A C B ( ) % % % 3 3.0% 4 0.1% 1 0.3% % 0.3% SDS 0.1% 0.3% 0.3% SDS 0.1% 3.0% SDS 0.1% 3.0%
77 3.0% SDS A 1B
78
79 , , % > 0.3 % 0.1% > 3.0 %
80 : , , % % 3 Modified classification on?
81 GHS 3.9 GHS (a) 3.1 (b) 3.2 (c) 3.3 (d) 3.4 (e) 3.5 (f) 3.6 (g) 3.7 (f) ( ) ( ) (3.8.3)
82
83 (a) 1 (b) (a) (b) (c) (d) (e)
84 (f) (g) (a) (b) (c) (d) (e)
85 3.8.1 a 1 2 mg/kg C C 300 mg/kg C C 1000 Ppm C C 2500 mg/ C C 10 mg/ /4 C C 1.0 b a b mg kg 2000 mg kg
86 (a) (b) (RTI) (c) (d) (e) (a) (b)
87 Bridging principles (a) 2 ( ) A+B ( ) C+B (b) B (c) ( ) A ( ) C (d) A C B
88 ( ) % 10% 10% 1.0% 1.0% 10% % 10% SDS 1.0% 10% % SDS % 10% % 10% SDS
89 1.0% 10% % SDS % % 20%
90
91 % 10% > 1.0 < 10% % 10%
92
93 GHS 3.8 GHS
94
95 (a) (b) (a) (b) (c) (d) (e) (f) (g)
96 (a) (b) (c) (d) (e)
97 3.9.1 ( ) mg/kg / 10 mg/kg / 20 ppm/6 / 50 mg/l/6 / 0.2 mg/l/6 / ( ) mg/kg / mg/kg / ppm/6 / mg/l/6 / mg/l/6 / mg kg 100mg kg ( )
98 Bridging principle
99 A B C A B C A B (a) 2 ( ) A+B ( ) C+B (b) B (c) ( ) A ( ) C (d) A C A C B ( )
100 % % 1 1.0% 10% 3 1.0% 10% 3 1.0% 4 10% % 10% SDS 1.0% 10% % SDS % 10% % 10% SDS 1.0% 10% % SDS %
101
102
103 % 10% > 1.0 < 10% % 10%
104
105 Aspiration Aspiration Hazard (mpa s) / (g/cm 3 ) = (mm 2 /s)
106 (a) (b) mm 2 /s mm 2 /s Bridging Principles %
107 (a) (b) 2 ( ) A + B ( ) C + B ; (c) ( ) ( ) ; (d) ( ) ( ) % mm 2 /s % mm 2 /s % mm 2 /s
108 % mm 2 /s
109 mm 2 /s mm 2 /s
110 % mm 2 /s % 40 14mm 2 /s
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1 967 2482 CAS 50000 CH 2 O 30.03 2952% 12.5 % 1. 2) -92 2) -19.5 2) 5085 3) 424 3) 7.073.0% 4) 20 d 4 0.815 5) 1.03 ( = 1) 5) 1.33 kpa (10 mmhg) (-88.0) 2) log Pow0.35 ( ) 6) 0.35 ( ) 7) 1) m/z 29 ( 1.0
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4 8 4 5 414.5 172.1 41.5% 39.8 10% 17 186.4 70.8 4 9 10 11 3 1-1 - 2-2 - - 3 - 10% - 4 - 4060% 5560% 60% 40% 3040 1520 1015 411 7 4 11 610 7080 5060 100 3040 13-5 - 1015 4045 3.04.0 5.06.0 1.52.0 1.01.5
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12 62 1800 14 3 11 14 4 14 4 30 ... 1... 1... 1... 2... 5... 6... 7... 10... 13... 18... 19 21 22 24 27 28 31 32 33... 34... 35... 37 2 1,650mm () H=2,500W=2,000 460m 750m 500m 42.1m 1.15m () 100% 80%
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1998 6 25 ( ) 1 10 1982 10 28 37/7 1990 12 14 45/94 (WHO) 1 1989 12 8 NGO (ECE) 3 1995 10 25 ECE 1991 2 25 1992 3 17 1998 6 4 1 2 1. 2. a b c (a) (b) d 17 3. a b (a) c (b) 4. 5. 3 1. 2. 3. 4. 5. 6. 7.
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56 20 57 58 59 12 60 ph 61 62 CCA 63 64 ( 1) 700 7.5 86% 54 17 71 2) 700 6.8 86% 50 15 65 3) 600 700 5.7 84% 36 14 50 550 650 4.2 80% 21 6 27 40 500 3.6 78% 16 7 23 3.6 78% 16 7 23 400 700 4.0 78% 18 7
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1 I. 3 1. 4 2. 6 3. 7 4. 8 4.1 8 4.2 ( ) 9 4.3 13 4.4 16 4.5 17 5. 19 5.1 20 5.2 25 5.3 33 6. 37 6.1 37 6.2 41 6.3 44 7. 46 7.1 46 7.2 47 II. 48 A 50 1 50 2 51 3 56 4 59 60 B 61 1 61 2 62 3 65 4 67 68
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