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EFFECTS ASSESSMENT Table 21 Default BMF values for organic substances log Kow of substance BCF (fish) BMF 8 – 9 2,000-5,000 3 >9 < 2,000 1 3.8.3.5 Calculation of the predicted no-effect concentration (PNECoral) Only toxicity studies reporting on dietary and oral exposure are relevant as the pathway for secondary poisoning is referring exclusively to the uptake through the food chain. Secondary poisoning effects on bird and mammal populations rarely become manifest in short-term studies. Therefore, results from long-term studies are strongly preferred, such as NOECs for mortality, reproduction or growth. If no adequate toxicity data for mammals or birds are available, an assessment of secondary poisoning cannot be made. For new substances, the results of mammalian repeated-dose toxicity tests are used to assess secondary poisoning effects. For existing substances and biocides, toxicity data for birds (e.g. OECD test 205 (1984h) (LC50, 5-day acute avian dietary study) or OECD test 206 (1984i) (chronic)) may also be present. Extrapolation from such test results gives a predicted no-effect concentration in food (PNECoral) that should be protective to other mammalian and avian species. Acute lethal doses LD50 (rat, bird) are not acceptable for extrapolation to chronic toxicity, as these are not dietary tests. Acute effect concentrations (e.g. OECD 205 (1984h)) for birds are acceptable for extrapolation. The results of the available mammalian or avian tests may be expressed as a concentration in the food (mg .kgfood -1 ) or a dose (mg .kg body weight .day -1 ) causing no effect. For the assessment of secondary poisoning, the results always have to be expressed as the concentration in food. In case toxicity data are given as NOAEL only, these NOAELs can be converted to NOECs with the following two formulae: Explanation of symbols 128 NOEC = NOAEL ⋅CONV bird bird bird (77) mammal, food _ chr = NOAELmammal, oral _ chr CONVmammal (78) NOEC ⋅ NOECbird NOEC for birds (kg . kgfood –1 ) NOECmammal, food chr NOEC for mammals (kg . kgfood –1 ) NOAELbird NOAEL for birds (kg . kg bw . d -1 ) NOAELmammal, oral chr NOAEL for mammals (kg . kg bw . d -1 ) CONVbird conversion factor from NOAEL to NOEC (kg bw . d . kgfood –1 ) Table 22 CONVmammal conversion factor from NOAEL to NOEC (kg bw . d . kgfood –1 ) Table 22
Conversion factors for laboratory animals are presented in Table 22. Table 22 Conversion factors from NOAEL to NOEC for several mammalian and one bird species Species Conversion factor (bw/dfi) Canis domesticus 40 Macaca sp. 20 Microtus spp. 8.3 Mus musculus 8.3 Oryctolagus cuniculus 33.3 Rattus norvegicus (> 6 weeks) 20 Rattus norvegicus (≤ 6 weeks) 10 Gallus domesticus 8 * bw = body weight (g); dfi: daily food intake (g/day) NOECs converted from NOAELs have the same priority as direct NOECs. EFFECTS ASSESSMENT The PNECoral is ultimately derived from the toxicity data (food basis) applying an assessment factor. In formula: Explanation of symbols TOX oral PNEC oral = (79) AForal PNECoral PNEC for secondary poisoning of birds and mammals [in kg . kgfood -1 ] AForal assessment factor applied in extrapolation of PNEC [-] Table 23 TOXoral either LC50 bird, NOECbird or NOECmammal, food, chr [in kg . kgfood -1 ] The assessment factor (AForal) takes into account interspecies variation, acute/subchronic to chronic extrapolation and laboratory data to field impact extrapolation. Some specific considerations need to be made for the use of the assessment factor for predators. CCME (1998) contains wildlife data on body weight and daily food ingestion rates for 27 bird and 10 mammalian species. In addition, Schudoma et al. (1999) derived the mean body weight and daily food intake for the otter. The currently available set on wildlife bw/dfi ratios ranges from 1.1 to 9 for birds and from 3.9 to 10 for mammalian species. Comparison of these wildlife conversion factors with the values given in Table 22 for laboratory species (8.3 – 40) shows that the wildlife species often have a lower bw/dfi ratio than laboratory animals. The difference can be up to a factor 8 for birds and 10 for mammals. This difference is in theory accounted for in the use of the interspecies variation factor that is part of the standard assessment factor. The interspecies variation, however, should comprise more than just the bw/dfi differences between species, e.g. the differences in intrinsic sensitivity. The protective value of the “normal” interspecies variation factor may therefore be questionable in case of predators. On top of that, many predator species are characterised by typical metabolic stages in their life-cycle that could make them extra sensitive to contaminants in comparison with laboratory animals (e.g. 129
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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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Explanation of symbols ENVIRONMENTA
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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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Page 87 and 88: Guidance for calculating PEClocal i
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Page 91 and 92: Explanation of symbols ENVIRONMENTA
Page 93 and 94: Calculation of PEClocalsoil For soi
Page 95 and 96: ENVIRONMENTAL EXPOSURE ASSESSMENT
Page 97 and 98: ENVIRONMENTAL EXPOSURE ASSESSMENT T
Page 99 and 100: Output ENVIRONMENTAL EXPOSURE ASSES
Page 101 and 102: 3 EFFECTS ASSESSMENT 3.1 INTRODUCTI
Page 103 and 104: 3.2.1.1 Completeness of data New su
Page 105 and 106: EFFECTS ASSESSMENT • it is clearl
Page 107 and 108: EFFECTS ASSESSMENT 3.3 EFFECTS ASSE
Page 109 and 110: Table 16 Assessment factors to deri
Page 111 and 112: Input data EFFECTS ASSESSMENT The m
Page 113 and 114: Estimation of the PNEC The PNEC is
Page 115 and 116: EFFECTS ASSESSMENT biodegradability
Page 117 and 118: Table 17 Test systems for derivatio
Page 119 and 120: EFFECTS ASSESSMENT representative o
Page 121 and 122: 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
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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 and 174: MARINE RISK ASSESSMENT mechanisms s
Page 175 and 176: MARINE RISK ASSESSMENT The use of t
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
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RISK CHARACTERISATION eaters. This
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6 TESTING STRATEGIES 6.1 INTRODUCTI
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TESTING STRATEGIES Performance of a
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TESTING STRATEGIES Care must be tak
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Algal testing Algae toxicity test (
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TESTING STRATEGIES • long-term te
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Microbial assays TESTING STRATEGIES
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TESTING STRATEGIES A soil bioassay
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REFERENCES Brandes LJ, den Hollande
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REFERENCES IPCS (2000). Framework f
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REFERENCES OECD (1984f). Activated
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REFERENCES Pack S. (1993). A review
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REFERENCES US EPA (1996). Whole Sed
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APPENDIX I volume imported in the E
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APPENDIX I MC IV “Wide dispersive
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APPENDIX I 210 Stage Main category
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APPENDIX I the number of days over
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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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