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REACH における化学物質安全性評価（CSA)の要点(案)

1. OC RMM BS
2. EUSES URL il RIVM wwwrivmanl CEFIC www cefic org EUSES
3. 1 Tier 1 FO UMS i 2 RISKOFDERM
4. Weight of Evidence 2 PBT 10 3
5. 1 2 OECD MNO GLP 6 Klimisch vitro in vivo
6. PBT vPyvB CMR Carcinogenic Mutagenic and Reproductive toxicity PBT vPvB 4 PBT PBT Assessment SVHCs Substances of Very High Concern
7. NN a COSHH BAuA URL http www REACH helpdesk de en Bxposure EBxposure html 0 SN
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9. 2 4 lt 5 H J Klimisch et Al A systematic Approach for Evaluating the Quality of Experimental Toxicology and Ecotoxicological Data Regulatory Toxicology and Pharmacology 23 1 5 1997 16 4 PBT PBT Assessment 4 1 PBT PBT vPyB 10 REACH PBT vPyB
10. CSA E 2 6 4 E MEI III 1 1 2 ES
11. REACH ECHA f REACH CSA CSA CSA 1 REACH CSA
12. SG S Service life
13. PNEC L E Csp 50 50 AF HH PNEC _ Min NOEC orlL E C PNEC om AF PANEComp Min NOEC L E C NOEC L E C PNEC AF CAS R 10
14. 19 5 Exposure Assessment 5 1 REACH CSA ES ES ES IU OC pH RMM
15. DUs DUs REACH DUs REACH ES DUs
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18. RMM TGD Excel 32 6 Risk Characterisation 6 1 REACH TU CSA NR Risk Characterisation
19. EO nT nN Ok 1 REACH CSA CSR SDS 2 Lk 3 Hazard Assessment 4 PBT PBT Assessment 5 Exposure Assessment 6 Risk Characterisation 7 CSR 8 1 3 4 9 6 7 Klimisch IUCLIDS CSR SDS Safety Data Sheet SRBASHLS4SO EE Weight of Evidence
20. REACH AC Article Category AF Assessment Factor Article Bioaccumulation Bioavailability Chemical Chemical Safety CMR Carcinogenic Mutagenic and Reproductive toxicity Concise Control of Risk CSA Chemical Safety Assessment CSR Chemical Safety Report Distributor DMEL Derived Minimal Effect Level DNEL Derived Non Effect Level Dose descriptor DUs Down Stream User ECHA Environmental Fate ERC E
21. QSAR SAR read across i CSA R 6 6 Kiimisch CSA R 4 REACH Klimisch 1 2 3
22. 3 4 2 PNEC Predicted No Effect Concentration REACH PNEC PNEC NOEC No Observed Effect Concentration PNEC L E DCs PNEC CSA R 10
23. DNEL DMEL DNEL DMEL CSA E 3 6 5 PEC Predicted Environmental Concentration PNEC PEC lt PNEC CSA E 2 7 Uncertainty Analysis CSA R19 REACH RCR DNEL PNEC PEC
24. SE 4 REACH IX X 5 NSR 7 2 CSR CSA F CSR
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26. 3 NRN 1 RMM ES O DUs ES 3 DUs e DUs e e DUs ES ii 2 DUs lt
27. REACH 8 2 SDS REACH REACH SDS WSDS REACH SDS eSDS Extended SDS PBT vPvB PNEC SDS 38 DNEL ES ES
28. PNEC DNEL RCR 6 2 0 1 PNECs DNELs DMELs DNEL 2 ES 3
29. 2 28 A B 2 A B S 11
30. 3 1 3 Hazard Assessment CSA REACH 1 f 1 1 TH 2 1 SIEF Substance Information Exchange Forum 4 CSA B 4 B 6 EE
31. A CMR 100 13 ee DNEL 30 ConsExpo URL http wwwr rivm nl en healthanddisease productsafety ConsExpo jsp EU EU 2004 1 Tier 1
32. 33 0 1 6 3 6 5 6 3 REACH CSR SDS e
33. CSA B 6 CSA DUs OCs RMM 3 2 REACH CSA 5 oo R 1 i vitro 2 REACH
34. REACH ES 2 Weight of Evidence CSA B 4 Weight of Evidence REACH ROR NE
35. DNEL DMEL DNEL DMEL CSA E 4 4 PNEC PEC PNEC
36. 3 CSR 4 ES DUs CSR eSDS Extended Safety Data Sheet 8 SDS 38 CSA G DUs 1 REACH REACH REACH REACH CSA
37. 2 Tier ss 5 2 5 2 14 1 Tier 1 l ES ES 2 Tier 2 DUs 5 2 5 2 6 DUs 10 2 Tier 2 CSA
38. 6 E DUs 1 2 10 PBT VPvB PBT vPvB E IUU DUs eb ES CSA D R 12 R 18 ES
39. DUs DUs REACH Downstream Users DU CSA oO H MI CSA s M I CSA REACH
40. ES ES CSA R 14 18 5 9
41. REACH DNEL PNEC CSA B 7 1 2 2 DNEL IG MDNEI DMEL CSA E 3 E
42. 3 ES Tiered Tier 1 higher tier Tier 2 CSA R 15 1
43. ES E ES G DUs G DUs 5 1 air Y rr 8 oe HUMANS MP groundwater drinking water Surface water fish wu 5 1 20 5 2 _ REACH REACH 3
44. CSA R 2 R S R 7 REACH VII X 3 0Cs Operational Conditions RMM Risk Management Measure R 7 Maa REACH CSA REACH R 7 E 2 REACH 4
45. CSA REACH ES 22 5 4 DU 2 ES i ii TUU ii UU s OC f ES E
46. 1 Tier 1 ConsExpo RMM 1 Tier 1 RMM ConsExpo EUSES Consumer URL http ecb jrc ec europa eu euses EU EU TGD EUSES
47. RMM 2 UL E E ERC EUSES Load E H ERC
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50. 15 3 6 OECD GLP Good Laboratory Practice 6 REACH Klimisch GLP
51. DNEL CSA 1 Tier1 Higher tier 11 10 11 12 ES ES RMM ES e ES OC
52. PBT vPvB PBT vPvB HH PBT vPvB H PBT vPvB 1 IU E 10 Emission characterisation RMM SN RMM OC DU s H E I HH
53. e e REACH A a a minor accident major accident Seveso II Directive 98 82 EEC6 REACH R
54. 7 3 8 9 0 CSA 1 CSA j Higher Tier 12 ES ES 14 CSR SDS 2 OC RMM 5 2 E ES 25 gt
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57. a Predicted Non Effect Concentration DNEL Derived Non Effect Level RCRs Risk Characterisation Ratios DNEL DMEL Derived Minimal Effect Level ES RCR 1 ES 3 RCR
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60. 3 5 3 5 1 REACH QSAR SAR CSA R 6 FFP HFP FT 5 wr CSA R 6 2 REACH read across
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63. OC RMM REACH ES SDS DUs ES SDS REACH SDS ES ES gk SDS ES
64. 4 3 4 3 4 1 3 1 2 jo QOSAR SAR read across 13 4 CSA R 8 REACH T DNEL PNEC
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66. DP RMM Risk Management Measure CSA 1 DNEL PNEC 2 3 1U 2 0 6 E AU UMUA WCW
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68. A G R 2 R 20 http reach jrc it docs guidance_ document7information requirements en htm http www chemical net info regulation html REACH
69. CSA B 7 1 CSA R 8 PNECs Predicted No Effect Concentrations CSA B 7 2 CSA R 10 PBT Persistent Bioaccumulative and Toxic vPvB Very Persistent and Very Bioaccumulative CSA C CSA R 11 CSA R 9 EU 67 548 EEC 1999 45 EC PBT vPvB PBT yvPvB
70. RMM EE RMM i DF PNEC DNEL 5 1 CSA ES 2 OC RMM
71. 6 6 7 8 ES Exposure Scenario CSA D Risk Characterisation CSA E CSA CSA CSA A 1 1 CSA EU 67 548 EEC BCB European Chemical Bureau 2015 GHS Globally Harmonised System of Classification and Labelling of Chemicals http ecb jrc ec europa eu classification labelling 1 HA lt EA a 2 4 RC 202 2500
72. en dose descriptor DNEL 1 DNEL Derived No Effect Level TU a DNEL 3 DNEL AF Assessment Factor AF NOAEL DNEL DNEL NOAEL _ NOAEL AFlx 472x A77 OverallAF DENL AF
73. DNEL PNEC NOAEL NOEC 2 REACH DNEL DNEL DMEL DNEL P
74. ES f DUs RMM U ES 1 Tier 1 ES ES H OC ES RMM
75. Bio Magnification Factor BMF 1 B vB Log Kow 4 3 OECD TG107 B QSAR ECS0 LCS0 0 01mgL OECD TG201 100 02 203 T 1 NOEC 30mg kg OECD TG 205 206 4 4 PBT yvPvyB REACH PBT vPvB 4 2 vPyB 4 2 REACH XIII PBT vPyvB Tj gt 60
76. CSR CSA CSR 1 CSA 2 PBT vPvB CSA REACH X 9 4 3
77. PBT 4 PBT vPvB E 4 2 4 1 PBT P vP OECD TG301 P OECD 302B C 7 70 14 70
78. DVUs TIU CSA CSA CSA IUCLIDS http 7iuclid echa europa eu A 4 1 2 CSA CSA 10 1l 2 3 4 5 1 1 CSA A DNELs Derived No Effect Levels
79. 2 1 2 1 A CSA B G Introduction B REACH B DNELs PNECs B R 2 R 10 C PBT vP
80. CSA SDS DUs end use produc0 DUs ES OC SDS SDS DUs RMM OC RMM ES ES SDS
81. CSR RMM RMM DUs RMM 26 5 3 RMM RMM 18 1 19 2 3 Handling 20
82. E i the main parameters determining the release and exposure OC E LL E ES ES 0 RMM ES CSR 21 SDS 1
83. II ES A EWAIE ES OW 3 5 6 RMM Risk Management Measure IS RMM RMM de MA RMM RMM REACH 5 3 31 RMM i RMM RMM WS CE
84. D 2 D 3 REACH 5 2 2 23 Ep CSA ES DUs OC RMM DUs ES MAS
85. BUSES RMM RMM 31 EUSES ERCs URL http ecb jrc ec europa eu euses http ecb jrceuses EUSES OC RMM 1 EU EU TGD CSA OC RMM 1 Tier
86. DUs DUs mn 9 REACH DUs
87. RCR Risk Characterisation Ratio R 19 F F CSA CSR CSR F CSR CSR CSR G e SDS Extended Safety Data Sheet ES G G DUs ES DUs e SDS
88. 1 2 1 1 CSA 1 3 REACH PBT vPyB PBT vPvB 1 4 CSA CSA 1 PBT vPvB 2 PBT vPvB ES
89. 1 Tier1 ES RMM e DUs ES es RMM RMM ES ES OC RMM ES DUs e s RMM e ES e ES RMM e
90. PBT vPyB CSA 4 2 PBT PBT vPvB 0 4 1 PBT vPvB PBT vPvB PBT vPvB 1 XIII PBT vPvB PBT vPvB PBT vPvB YN 1 67 548 EEC
91. DUs REACH eSDS Extended Safety Data Sheet 2 ECHA European Chemicals Agency CSA CSA REACH REACH f tN CSA CSA CSR CSA A G
92. PBT PBT vPvB 4 2 2 PBT vPvB 2 U DC 3 RMM OCs
93. 3 CSA R 14 S 10 lt
94. 3 ES ES ES S 13 REACH E 29 ECETOC TRA occupational https wwwr ecetoc tra org index asD PROC EASE
95. PBT vPvB PBT vPvB 1 emission characterisation PBT vPvB I 0 1 PBT vPvB PBT vyPvB EU HH PBT vPvB 0 1 PBT vPvB E REACH 14
96. R 2 R 20 2 1 R 2 R 3 F R 4 R S R 6 QSAR R 7 A li R S E R 9 R 10 C PBT yPyB 1 R 11 PBT vPvB H D RMM OC R 14 R 1S R 16 R 17 R 18 E 2 1 CSA
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101. 5 5 3 13 OC RMM Tier e ES s ES e e CSR SDS ES ts Gi E ES 5 5 lt REACH ES 1 SU Sector of Use 2 PC Chemical Product Category 3 PROC Process Category 4 AC Article Category CSA R 12 ERC Environmental Release Category CSA R 16
102. 4 1 GLP 2 2 R22 R PP GLP 3
103. 4 21 5 22 6 23 24 7 25 8 26 9 10 27 11 12 28 13 29 14 disposal 30 31 15 16 17 5 7 ES GS Ff a ks
104. 3 1 2 1 2 3 http 7mahbsry jrc itC GuidanceDocs SafetyManagementSystems htm Section3 2 34 E RCR DNEL RCR 1 DNEL RCR gt 1 gt DNEL
105. CSA M I Manufacture or Import er DUs Downstream Users MI CSR H TU Identified Use REACH 326 SDS Safety Data Sheet DUs CSA
106. REACH CSR 8 CSR EC CSA A 1 RMM 2 RMM 3 RMM B 1 9 3 4 5 6 7 8 PBT vPvB 9 1 10 36 37 8 SDS Safety Data Sheet 8 1 REACH SDS SDS 0
107. ELHA 20 REACH 1 Chemicals 2007 12 REACH European Chemicals Agency REACH REACH Manufacturer 3 REACH Registration Evaluation Authorisation and Restriction E6 1 O 3 Hn of REACH 2008 6 1 ECHA E tmporter CSA Chemical Safety Assessment
108. NEC 3 3 3 _DNEL DNEL DMEL Derived Minimal Effect Level DMEL AF DMEL CSA R 8
109. ety Assessment CSR Chemical Safety Report 10 TUCLIDS International Uniform Chemical Information Database CSR REACH 10 CSA CSR BCHA European Chemicals Agency
110. n RCR Risk Characterisation Ratio RMM Risk Management Measure SDS Safety Data Sheet SIEF Substance Information Exchange Forum SU sector of use Supply Chain SVHC Substance of Very High Concern Technical Dossier 6 Using vPvB Very Persistent and Very BioaccumulatiVe Waving 40 REACH li ECHA European Chemicals Agency http echa europa eu home en asp ECB European Chemical Bureau REACH http ecb jrc ec europa eu reach CEFIC European Chemical Industry Council REACH http www
111. nvironmental Release Category ES Exposure Scenario Exposure Exposure estimation Extended e Safety Data Sheet Formulator GLP Good Laboratory Practice Hazard IU Identified Use IUCLID International Unitorm Chemical Information Database Measured Data M I Manufacturer or Importer NOAEL No Observed Adverse Effect Level Non testing approach OC Operational Condition PBT Persistent Bioaccumulative and Toxic PC Chemical Product Category PEC Predicted Environmental y Concentration Preset Condition Persistent PNEC Predicted No Effect Concentration PROC Process Category 39 Read across Registration Dossier Risk Characterisatio
112. reachcentrum eu http www nikkakyo org reach http wwwrjetoc or 1p index html REACH http wwwr reachcenter jp http www chemical net info index html http www meti go jp policy chemical management intreach html http wwwr enV go jp chemi reach reach html 41
113. yB Ch PBT vPvB R 11 PBT D lt BS D ES 2 SN ES R 12 R 18 E E

REACH における化学物質安全性評価（CSA)の要点(案)

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