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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

http://www.who.int/ipcs/publications/ehc/en/index.html EHC 1 2 3 4 / EHC http://www.nihs.go.jp/dcbi/publist/ehchsg/ 1-8) WHO/IPCS CICAD (Concise Inter

http://www.who.int/ipcs/publications/ehc/en/index.html EHC 1 2 3 4 / EHC http://www.nihs.go.jp/dcbi/publist/ehchsg/ 1-8) WHO/IPCS CICAD (Concise Inter 3 [ ] Priority IARC JMPR 2004 10 Priority 1 Priority 1 Priority 2 Priority 3 Priority 1 1-1) CERI) http://www.cerij.or.jp/ceri_jp/koukai/sheet/sheet_indx4.htm http://www.safe.nite.go.jp/data/sougou/pk_list.html?table_name=hyoka&rank=sh

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