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MARINE RISK ASSESSMENT Table 31 Overview of P-assignment for different types of biodegradation data Type of data Criterion Definitive assignment Screening assignment 1) DT50 marine water > 60 d VP - DT50 freshwater 2) 168 > 40 d P 3) - > 60 d VP - DT50 marine sediment > 180 d VP - DT50 freshwater sediment 2) Readily biodegradable 4) Inherently degradable QSAR Non-linear model prediction < 0.5 or MITI non-linear model prediction < 0.5 and Ultimate biodegradation timeframe prediction < 2.2 > 120 d P 3) - > 180 d VP - Yes Not P - No - P or vP Yes Not P 5) - No - P or vP - P or vP 1) These screening methods give an “open-ended” categorisation of the substance as either being potentially P or vP, which cannot easily be related to a half-life for biodegradation. 2) Data for estuaries should also be considered in this category. 3) Half-life data in freshwater and freshwater sediment can be overruled by data obtained under marine conditions. 4) Regardless of whether the 10-d window criterion is fulfilled. 5) This only applies to cases where the specific criteria as mentioned in Section 4.4.3.3 are fulfilled. 4.4.4 Testing strategy for the B criterion 4.4.4.1 Introduction Substances can accumulate in aquatic organisms directly from the water, i.e. bioconcentration, or via uptake through the foodchain, i.e. biomagnification. A high bioaccumulation potential of a substance is of particular concern for the marine environment due to the possible accumulation in the foodchains and the potential long-term effects that may occur in organisms at the top of these foodchains. Whereas different models and parameters are available to evaluate bioconcentration for organic chemicals, suitable parameters to evaluate accumulation in marine foodchains are not available. The bioconcentration factor (BCF) in aquatic organisms is traditionally used as a first indicator for bioaccumulation (see Section 3.8.2). In principle, the assessment of the (potential for) bioaccumulation in the context of the PBT assessment makes use of measured bioconcentration factors in marine or freshwater organisms. Where these are not available BCF values may be estimated from the octanol/water partition coefficient (Kow) using QSAR models. In addition, Kow values, either experimentally determined or estimated can be used directly to assess the potential for bioaccumulation.
4.4.4.2 Assessment of measured BCF data MARINE RISK ASSESSMENT The decision whether or not a substance fulfils the B criterion should in principle be based on measured data on bioconcentration in aquatic species. Data from freshwater as well as marine species can be used. Extensive guidance on the quality assessment of such data can be found elsewhere (e.g. OECD, 2001c). A substance is considered to fulfil the B criterion when the measured BCF on a wet weight basis exceeds a value of 2,000. A substance is considered very bioaccumulative (vB) when the BCF exceeds a value of 5,000. 4.4.4.3 Assessment of the potential for bioaccumulation When measured BCF values are not available the Kow or the BCF based on modelling can be used to indicate the liability to bioaccumulate from water. For substances with log Kow < 6 assessment on the basis of Kow or estimated BCF does not make a real difference since all available BCF models are linear (see Section 3.8.3.2). The B criterion for log Kow is therefore directly derived from this linear relationship. A substance is considered to potentially fulfil the B criterion when log Kow exceeds a value of 4.5. For highly hydrophobic substances, e.g. with log Kow > 6, experimentally derived BCF values tend to decrease with increasing log Kow. Several conceptual explanations as well as explanations referring to experimental artefacts can be given for this decline. For these substances the available BCF models can lead to very different results. As a consequence the potential for bioaccumulation is assessed by expert judgement on the basis of the log Kow value and the estimated BCF using the available BCF models. Such an assessment must be done on a case-by-case basis taking into account what is known about the BCF QSAR-models and the specific properties of the substance, in particular what is known to affect uptake and the potential for metabolism in aquatic organisms. Care must be taken that substances with high log Kow values are not deleted from selection processes without applying expert judgement to them. It must be noted that for priority existing substances, new substances and biocides a measured octanol/water partition coefficient is usually available. Additionally a range of QSAR models can be used to estimate this parameter (see e.g. Chapter 4, Meylan et al., 1999; OECD, 2001c). 4.4.4.4 Other information relevant for assessment of the B criterion In addition to the above-mentioned data on bioconcentration or bioaccumulation in aquatic species evidence that a substance shows high bioaccumulation in other species may also be used to decide whether the B criterion is fulfilled. Such evidence may be based on information from specific laboratory tests or from field studies. Specific attention needs to be paid to measured data in biota. Measured data in biota are a clear indicator that a substance is taken up by an organism. However, they are not an indicator that significant bioconcentration or bioaccumulation has occurred. The interpretation of such data in terms of actual bioaccumulation or biomagnification factors can especially be difficult when the sources and levels of the exposure (through water as well as through food) are not known or cannot be estimated reasonably. 169
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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
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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
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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
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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
Page 224 and 225: 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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