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MARINE RISK ASSESSMENT • when a substance does not fulfil the criteria for ready biodegradability as defined in sections on biodegradation and for the marine ready test (see Sections 2.3.6 and 4.2.3.4), it is considered as being potentially persistent. The 10-day window criterion should not be used here as an additional criterion. If the substance fulfils the criteria for B and T, further testing is needed. It must be noted that in this case it is not considered appropriate to perform inherent biodegradability tests but rather to go directly to simulation testing; • when results are available showing that a substance does not fulfil the criteria for inherent biodegradability as defined within the Annex V method or the OECD guideline this is a clear indication that the substance will not biodegrade in the marine environment either. The substance will be regarded as potentially persistent. When the (screening) criteria for B and T are also fulfilled, further testing is needed in order to determine the half-life in the environment. • when a substance passes the criteria for inherent biodegradability tests this does not necessarily indicate that it will not be persistent under environmental conditions. However, in order to make the best use of available information it is accepted to use the results of two specific tests when they fulfil certain criteria as an indication that the substance is not persistent. These test are: - Zahn-Wellens Test (EU Annex V C.9, OECD 302B, 1992g): Pass level (70% mineralisation) must be reached within 7 days, log-phase should be no longer than 3 days, percentage removal in the test before degradation occurs should be below 15%, not tested with pre-adapted microorganisms; - MITI II -test (OECD 302C, 1981d): Pass level must be reached within 14 days; logphase should be no longer than 3 days, not tested with pre-adapted microorganisms. In case a range of biodegradation data, including conflicting data, is available, a case-by-case assessment is needed, using a weight of evidence approach, in order to decide whether a substance has the potential to be persistent (see also Section 2.3.6). 4.4.3.4 Data from biodegradation estimation models For new substances, priority existing substances and biocides, information from a ready biodegradability test is normally available and therefore an initial decision whether the substance is potentially persistent can be taken. However, for many other substances no data will be available or the available information is difficult to interpret. For these substances it can be helpful to apply models that estimate the potential for biodegradation in the environment. In a preliminary assessment whether a substance has a potential for persistence in the marine environment and hence for asking for actual test data it is proposed to consider use of the BIOWIN program. This program estimates aerobic biodegradability of organic chemicals using 6 different models: 1. linear model, 2. non-linear model, 3. ultimate biodegradability timeframe model, 4. primary biodegradability timeframe model, 5. MITI linear model, 6. MITI non-linear model; 166
MARINE RISK ASSESSMENT The use of the results of these programs in a conservative way may fulfil the needs for evaluating the potential for persistency. The use of three out of the six models is suggested as follows: • non-linear model prediction: does not biodegrade fast (
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Institute for Health and Consumer P
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LEGAL NOTICE Neither the European C
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OVERVIEW This Technical Guidance Do
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CONTENTS 1 GENERAL INTRODUCTION ...
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4.2.3.4 Use of biodegradation scree
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1 GENERAL INTRODUCTION 1.1 BACKGROU
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GENERAL INTRODUCTION countries in t
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GENERAL INTRODUCTION PNEC is regard
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2 ENVIRONMENTAL EXPOSURE ASSESSMENT
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ENVIRONMENTAL EXPOSURE ASSESSMENT r
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2.2 MEASURED DATA ENVIRONMENTAL EXP
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ENVIRONMENTAL EXPOSURE ASSESSMENT w
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ENVIRONMENTAL EXPOSURE ASSESSMENT o
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ENVIRONMENTAL EXPOSURE ASSESSMENT T
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ENVIRONMENTAL EXPOSURE ASSESSMENT r
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Production ENVIRONMENTAL EXPOSURE A
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Back to processing Product at end o
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ENVIRONMENTAL EXPOSURE ASSESSMENT s
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Explanation of symbols ENVIRONMENTA
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ENVIRONMENTAL EXPOSURE ASSESSMENT s
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ENVIRONMENTAL EXPOSURE ASSESSMENT U
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ENVIRONMENTAL EXPOSURE ASSESSMENT a
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ENVIRONMENTAL EXPOSURE ASSESSMENT F
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2.3.5.1 Adsorption to aerosol parti
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ENVIRONMENTAL EXPOSURE ASSESSMENT I
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2.3.6.1 Hydrolysis ENVIRONMENTAL EX
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2.3.6.3 Photochemical reactions in
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constant of zero. However, if it ca
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ENVIRONMENTAL EXPOSURE ASSESSMENT A
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ENVIRONMENTAL EXPOSURE ASSESSMENT a
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Primary Settler Aeration Tank 2 5 3
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ENVIRONMENTAL EXPOSURE ASSESSMENT I
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ENVIRONMENTAL EXPOSURE ASSESSMENT d
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ENVIRONMENTAL EXPOSURE ASSESSMENT e
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Table 10 Overview of different expo
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ENVIRONMENTAL EXPOSURE ASSESSMENT -
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2.3.8.3 Calculation of PEClocal for
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ENVIRONMENTAL EXPOSURE ASSESSMENT W
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Guidance for calculating PEClocal i
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Concentration (% of initial) 160 14
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Calculation of PEClocalsoil For soi
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ENVIRONMENTAL EXPOSURE ASSESSMENT
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Output ENVIRONMENTAL EXPOSURE ASSES
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3 EFFECTS ASSESSMENT 3.1 INTRODUCTI
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3.2.1.1 Completeness of data New su
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EFFECTS ASSESSMENT • it is clearl
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EFFECTS ASSESSMENT 3.3 EFFECTS ASSE
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Table 16 Assessment factors to deri
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Input data EFFECTS ASSESSMENT The m
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Estimation of the PNEC The PNEC is
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EFFECTS ASSESSMENT biodegradability
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Table 17 Test systems for derivatio
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EFFECTS ASSESSMENT representative o
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In the partitioning method, it is a
Page 123 and 124: EFFECTS ASSESSMENT As mentioned in
Page 125 and 126: 3.6.2.1 Calculation of PNEC using t
Page 127 and 128: 3.7 EFFECTS ASSESSMENT FOR THE AIR
Page 129 and 130: EFFECTS ASSESSMENT procedure availa
Page 131 and 132: EFFECTS ASSESSMENT bioaccumulation
Page 133 and 134: EFFECTS ASSESSMENT For some chemica
Page 135 and 136: EFFECTS ASSESSMENT i.e. without enh
Page 137 and 138: Conversion factors for laboratory a
Page 139 and 140: EFFECTS ASSESSMENT • relative sen
Page 141 and 142: EFFECTS ASSESSMENT Earthworms are a
Page 143 and 144: MARINE RISK ASSESSMENT environment
Page 145 and 146: MARINE RISK ASSESSMENT of equal rel
Page 147 and 148: 4.2.3.3 Marine biodegradation simul
Page 149 and 150: MARINE RISK ASSESSMENT In addition
Page 151 and 152: Explanation of symbols MARINE RISK
Page 153 and 154: MARINE RISK ASSESSMENT evaluate the
Page 155 and 156: MARINE RISK ASSESSMENT marine water
Page 157 and 158: MARINE RISK ASSESSMENT The addition
Page 159 and 160: MARINE RISK ASSESSMENT Statistical
Page 161 and 162: MARINE RISK ASSESSMENT sediment, fo
Page 163 and 164: Table 27 Assessment factors for der
Page 165 and 166: Table 28 continued Acute and chroni
Page 167 and 168: MARINE RISK ASSESSMENT of different
Page 169 and 170: MARINE RISK ASSESSMENT • a measur
Page 171 and 172: MARINE RISK ASSESSMENT b. the conce
Page 173: MARINE RISK ASSESSMENT mechanisms s
Page 177 and 178: 4.4.4.2 Assessment of measured BCF
Page 179 and 180: MARINE RISK ASSESSMENT required to
Page 181 and 182: Table 33 Overview of PEC/PNEC ratio
Page 183 and 184: RISK CHARACTERISATION If a refineme
Page 185 and 186: Classified dangerous to the Environ
Page 187 and 188: RISK CHARACTERISATION eaters. This
Page 189 and 190: 6 TESTING STRATEGIES 6.1 INTRODUCTI
Page 191 and 192: TESTING STRATEGIES Performance of a
Page 193 and 194: TESTING STRATEGIES Care must be tak
Page 195 and 196: Algal testing Algae toxicity test (
Page 197 and 198: TESTING STRATEGIES • long-term te
Page 199 and 200: Microbial assays TESTING STRATEGIES
Page 201 and 202: TESTING STRATEGIES A soil bioassay
Page 203 and 204: REFERENCES Brandes LJ, den Hollande
Page 205 and 206: REFERENCES IPCS (2000). Framework f
Page 207 and 208: REFERENCES OECD (1984f). Activated
Page 209 and 210: REFERENCES Pack S. (1993). A review
Page 211: REFERENCES US EPA (1996). Whole Sed
Page 214 and 215: APPENDIX I volume imported in the E
Page 216 and 217: APPENDIX I MC IV “Wide dispersive
Page 218 and 219: APPENDIX I 210 Stage Main category
Page 220 and 221: APPENDIX I the number of days over
Page 222 and 223: APPENDIX I Stage Main category Ia I
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APPENDIX I manufacturing of motor c
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APPENDIX I 1. extension of the tabl
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APPENDIX I 220 A-tables Estimates f
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APPENDIX I PRIVATE USE Not applicab
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APPENDIX I IC = 3: CHEMICAL INDUSTR
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APPENDIX I IC = 5: PERSONAL /DOMEST
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APPENDIX I Table A4.1 continued Com
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APPENDIX I IC = 7: LEATHER PROCESSI
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APPENDIX I IC = 9: MINERAL OIL AND
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APPENDIX I WASTE TREATMENT Table A5
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APPENDIX I For the emission factors
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APPENDIX I INDUSTRIAL USE Table A3.
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APPENDIX I INDUSTRIAL USE Table A3.
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APPENDIX I PRIVATE USE Table A4.5 C
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APPENDIX I PRIVATE USE Table A3.16
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APPENDIX I 246 B-tables Estimates f
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APPENDIX I FORMULATION Table B2.2 f
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APPENDIX I IC = 3: CHEMICAL INDUSTR
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APPENDIX I IC = 5: PERSONAL/DOMESTI
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APPENDIX I IC = 7: LEATHER PROCESSI
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APPENDIX I IC = 9: MINERAL OIL AND
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APPENDIX I IC = 11: POLYMERS INDUST
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APPENDIX I IC =13: TEXTILE PROCESSI
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APPENDIX I IC = 16: ENGINEERING IND
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APPENDIX I Appendix I-a: List of sy
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APPENDIX I No. Use Category No. Fun
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APPENDIX I Appendix I-b: List of sy
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APPENDIX I 290 Organic intermediate
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APPENDIX I Other IC/UC combinations
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APPENDIX II Appendix II Fate of che
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APPENDIX II b) Inherent biodegradab
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APPENDIX II log H % removal -4 -3 -
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APPENDIX III Appendix III Evaluatio
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APPENDIX III Field studies In gener
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APPENDIX IV together the mentioned
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290 Table 1 Selected soil test meth
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292 Table 1 continued Selected soil
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298 Table 1 Selected freshwater sed
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APPENDIX VII Appendix VII Toxicity
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APPENDIX VIII collection), and that
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APPENDIX VIII chemicals (see Sectio
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APPENDIX VIII Multimedia fate model
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APPENDIX VIII Monitoring data Metal
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APPENDIX VIII homeostatic regulatio
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APPENDIX IX based on the proportion
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APPENDIX IX Definition of “blocks
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APPENDIX IX these “blocks” will
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APPENDIX IX and PNECs for the “bl
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APPENDIX XI Appendix XI Environment
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APPENDIX XII Appendix XII Connectio
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APPENDIX XII +40% compared to 1992.
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APPENDIX XIII other substance is be
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APPENDIX XIV Taxonomic group No. of
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