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EFFECTS ASSESSMENT environments but in case enough data are available, they may be used also for other environments. 3.3.1.1 Calculation of PNEC using assessment factors The proposed assessment factors are presented in Table 16. When only short-term toxicity data are available, an assessment factor of 1000 will be applied on the lowest L(E)C50 of the relevant available toxicity data, irrespective of whether or not the species tested is a standard test organism (see notes to Table 16). A lower assessment factor will be applied on the lowest NOEC derived in long-term tests with a relevant test organism. For some compounds, a large number of validated short-term L(E)C50 values may be available. Therefore, it is proposed to calculate the geometric mean if more than one L(E)C50 value is available for the same species and end-point. Prior to calculating the geometric mean an analysis of test conditions must be carried out in order to find out why differences in response were present. The algal growth inhibition test of the base-set is, in principle, a multigeneration test. However, for the purposes of applying the appropriate assessment factors, the EC50 is treated as a shortterm toxicity value. The NOEC from this test may be used as an additional NOEC when other long-term data are available. In general, an algal NOEC should not be used unsupported by longterm NOECs of species of other trophic levels. However, if the short-term algal toxicity test is the most sensitive of the short-term tests, the NOEC from this test should be supported by the result of a test on a second species of algae. Microorganisms representing a further trophic level may only be used if non-adapted pure cultures were tested. The investigations with bacteria (e.g. growth tests) are regarded as shortterm tests. Additionally, blue-green algae should be counted among the primary producers due to their autotrophic nutrition. The assessment factors presented in Table 16 below should be considered as general factors that under certain circumstances may be changed. In general, justification for changing the assessment factor could include one or more of the following: • evidence from structurally similar compounds (Evidence from a closely related compound may demonstrate that a higher or lower factor may be appropriate); • knowledge of the mode of action including endocrine disrupting effects (Some substances, by virtue of their structure, may be known to act in a non-specific manner); • the availability of test data from a wide selection of species covering additional taxonomic groups other than those represented by the base-set species; • the availability of test data from a variety of species covering the taxonomic groups of the base-set species across at least three trophic levels. In such a case the assessment factors may only be lowered if these multiple data points are available for the most sensitive taxonomic group. Specific comments on the use of assessment factors in relation to the available data set are given in the notes below Table 16. 100
Table 16 Assessment factors to derive a PNECaquatic Available data Assessment factor At least one short-term L(E)C50 from each of three trophic levels of the baseset (fish, Daphnia and algae) 1000 a) One long-term NOEC (either fish or Daphnia) 100 b) Two long-term NOECs from species representing two trophic levels (fish and/or Daphnia and/or algae) Long-term NOECs from at least three species (normally fish, Daphnia and algae) representing three trophic levels 50 c) 10 d) EFFECTS ASSESSMENT Species sensitivity distribution (SSD) method 5-1 (to be fully justified case by case) e) Field data or model ecosystems Reviewed on a case by case basis f) Notes to Table 16: a) The use of a factor of 1000 on short-term toxicity data is a conservative and protective factor and is designed to ensure that substances with the potential to cause adverse effects are identified in the effects assessment. It assumes that each of the uncertainties identified above makes a significant contribution to the overall uncertainty. For any given substance there may be evidence that this is not so, or that one particular component of the uncertainty is more important than any other. In these circumstances it may be necessary to vary this factor. This variation may lead to a raised or lowered assessment factor depending on the available evidence. A factor lower than 100 should not be used in deriving a PNECwater from short-term toxicity data except for substances with intermittent release (see Section 3.3.2). There are cases where the base-set is not complete: e.g. for substances that are produced at
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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 T
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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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Page 61 and 62: constant of zero. However, if it ca
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Page 65 and 66: ENVIRONMENTAL EXPOSURE ASSESSMENT T
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Page 69 and 70: Primary Settler Aeration Tank 2 5 3
Page 71 and 72: Explanation of symbols ENVIRONMENTA
Page 73 and 74: ENVIRONMENTAL EXPOSURE ASSESSMENT I
Page 75 and 76: ENVIRONMENTAL EXPOSURE ASSESSMENT d
Page 77 and 78: ENVIRONMENTAL EXPOSURE ASSESSMENT e
Page 79 and 80: Table 10 Overview of different expo
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Page 83 and 84: 2.3.8.3 Calculation of PEClocal for
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Page 87 and 88: Guidance for calculating PEClocal i
Page 89 and 90: Concentration (% of initial) 160 14
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: EFFECTS ASSESSMENT 3.3 EFFECTS ASSE
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
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
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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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