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ENVIRONMENTAL EXPOSURE ASSESSMENT The outcome of the alternative exposure assessments should be presented in an illustrative appendix to the risk assessment report. If the analysis shows that the variation of the input parameter(s) is critical in relation to the result of the assessment (i.e. changes the conclusion), then further consideration is necessary of ways to improve the certainty of the input parameter(s) in question. If on the other hand the analysis shows that the results of the assessment are not changed, the confidence in the assessment has increased. 2.3.2 Data for exposure models The following parameters from the base-set are directly used in the exposure models as discussed in the following sections: Physico-chemical properties MOLW molecular weight [g . mol -1 ] Kow 2 octanol water partitioning coefficient [-] SOL water solubility [mg . l -1 ] VP vapour pressure [Pa] BOILPT boiling point (only for some release estimations) [°C] Use pattern of the substance PRODVOL production volume of substance [tonnes . yr -1 ] IMPORT volume of substance imported [tonnes . yr -1 ] EXPORT volume of substance exported [tonnes . yr -1 ] INDCAT industrial category [-] USECAT use category [-] MAINCAT main category (for existing substances) [-] Specific information on the use pattern of the substance Sections 2.3.5 and 2.3.6 describe how secondary data (partition coefficients and degradation rates) are derived from the minimum data requirements. When adequately measured data are known, these should be used instead of the estimations. It should be noted that the data requirements for the exposure models, as listed above, are only valid for neutral, organic, non-ionised substances. Before proceeding with the modelling exercise due consideration should be given whether the substance can be classified as a neutral, organic, non-ionised substance. More specific information (e.g. partition coefficients or pKa/pKb for ionising substances) may be required for other types of substances. For ionising substances, the pH-dependence of Kow and water solubility should be known. Partition coefficients should be corrected according to the pH of the environment (see Appendix XI). For surface active substances it may not be advisable to use estimated or measured Kow values as a predictor for e.g. Koc (soil, sediment, suspended organic matter and sludge) and BCF (fish, worm) because the predictive value of log Kow for such estimations may be too low. Instead, for surfactants it may be appropriate to obtain measured Kp and BCF values. If experimentally determined physico-chemical data have been obtained at a temperature which for the substance under consideration would significantly change when extrapolated to the 2 The term Kow is used in this document and is equivalent to Pow. 24
ENVIRONMENTAL EXPOSURE ASSESSMENT relevant temperature of the exposure models employed (e.g. 12 o C in the regional model) then such an extrapolation should be considered. In most cases this will not be necessary. However, the vapour pressure may for some substances change considerably according to the temperature even within a temperature range of only 10 o C. In this case a general temperature correction should be applied according to the following equation: Explanation of symbols VP ( ) ⎟ ⎟ ⎟ ⎞ 1 1 ⋅ − ⎛ ⎜ H 0vapor ⎜ ⎜ R TEMP TEMP ⎝ test env ⎠ ( TEMPenv ) = VP( TEMPtest ) ⋅ e (2) VP(TEMPenv) vapour pressure at the environmental temperature [Pa] VP(TEMPtest) vapour pressure as give in the data set [Pa] data set TEMPenv environmental temperature (scale-dependent) [K] TEMPtest temperature of the measured experimental VP [K] H0vapor enthalpy of vapourisation [J/mol] 5 . 10 4 R gas constant [Pa . m 3 /(mol . K)] 8.314 Care must be taken when the melting point is within the extrapolated temperature range. The vapour pressure of the solid phase is always lower than the extrapolated vapour pressure of the liquid phase. Extrapolation will therefore tend to overestimate the vapour pressure. There is no general solution to this problem. The same approach can be followed for correcting the water solubility: Explanation of symbols SOL ( ) ⎟ ⎟ ⎞ 1 1 ⋅ − ⎛ ⎜ H 0solut ⎜ R TEMP TEMP ⎝ test env ⎠ ( TEMPenv ) = SOL( TEMPtest ) ⋅ e (3) SOL(TEMPenv) solubility at the environmental temperature [Pa] SOL(TEMPtest) solubility as give in the data set [Pa] data set TEMPenv environmental temperature (scale-dependent) [K] TEMPtest temperature of the measured experimental SOL [K] H0solut enthalpy of solution [J/mol] 1 . 10 4 R gas constant [Pa . m 3 /(mol . K)] 8.314 2.3.3 Release estimation In this section the following parameters are derived: • local emission, the rates to air and waste during an emission episode; • regional emissions to air, wastewater, and industrial soil (annual averages). 25
Page 1: Institute for Health and Consumer P
Page 4 and 5: LEGAL NOTICE Neither the European C
Page 7: OVERVIEW This Technical Guidance Do
Page 11 and 12: CONTENTS 1 GENERAL INTRODUCTION ...
Page 13 and 14: 4.2.3.4 Use of biodegradation scree
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Page 17 and 18: GENERAL INTRODUCTION countries in t
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Page 43 and 44: Explanation of symbols ENVIRONMENTA
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Page 69 and 70: Primary Settler Aeration Tank 2 5 3
Page 71 and 72: Explanation of symbols ENVIRONMENTA
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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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Explanation of symbols ENVIRONMENTA
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Calculation of PEClocalsoil For soi
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ENVIRONMENTAL EXPOSURE ASSESSMENT
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ENVIRONMENTAL EXPOSURE ASSESSMENT T
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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
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3.6.2.1 Calculation of PNEC using t
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3.7 EFFECTS ASSESSMENT FOR THE AIR
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EFFECTS ASSESSMENT procedure availa
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EFFECTS ASSESSMENT bioaccumulation
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EFFECTS ASSESSMENT For some chemica
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EFFECTS ASSESSMENT i.e. without enh
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Conversion factors for laboratory a
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EFFECTS ASSESSMENT • relative sen
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EFFECTS ASSESSMENT Earthworms are a
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MARINE RISK ASSESSMENT environment
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MARINE RISK ASSESSMENT of equal rel
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4.2.3.3 Marine biodegradation simul
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MARINE RISK ASSESSMENT In addition
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Explanation of symbols MARINE RISK
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MARINE RISK ASSESSMENT evaluate the
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MARINE RISK ASSESSMENT marine water
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MARINE RISK ASSESSMENT The addition
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MARINE RISK ASSESSMENT Statistical
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MARINE RISK ASSESSMENT sediment, fo
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Table 27 Assessment factors for der
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Table 28 continued Acute and chroni
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MARINE RISK ASSESSMENT of different
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MARINE RISK ASSESSMENT • a measur
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MARINE RISK ASSESSMENT b. the conce
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MARINE RISK ASSESSMENT mechanisms s
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MARINE RISK ASSESSMENT The use of t
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4.4.4.2 Assessment of measured BCF
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MARINE RISK ASSESSMENT required to
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Table 33 Overview of PEC/PNEC ratio
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RISK CHARACTERISATION If a refineme
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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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