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EFFECTS ASSESSMENT 3.5.4 Calculation of PNEC using assessment factors If results from whole-sediment tests with benthic organisms are available the PNECsed has to be derived from these tests using assessment factors. However, the available sediment tests should be carefully evaluated. Special attention should be given to the pathways through which the test organisms are exposed to the chemical and the test protocol should carefully be checked, whether feeding with unspiked food has possibly reduced exposure via sediment ingestion. For assessing the toxicity of spiked sediment it is necessary to address adequately all possible routes of exposure. Sediment organisms can be exposed via their body surfaces to substances in solution in the overlying water and in the pore water and to bound substances by direct contact or via ingestion of contaminated sediment particles. The route that is most important is strongly influenced by species-specific feeding mechanisms and the behaviour of the organism in, or on, the sediment. Test design parameters can have a bearing on the route of uptake of a substance. A number of uncertainties have to be addressed (cf. Chapter 3.3.1) in establishing the size of the assessment factors. In contrast to the principle adopted for the aquatic compartment, it is not necessary to have 3 acute sediment tests for the assessment factor of 1000 to be applicable. Results from long-term tests with sub-lethal endpoints such as reproduction, growth, emergence, sediment avoidance and burrowing activity are regarded as most relevant due to the generally long-term exposure of benthic organisms to sediment-bound substances. Consequently, if results from short-term tests with sediment-dwelling organisms are only available (at least one) an assessment factor of 1000 is applied to the lowest value. In addition, the PNECsed should also be calculated from the PNECwater using the equilibrium-partitioning method. A reduction in the size of the assessment factor should only be accepted if results form long-term tests with sedimentdwelling organisms are available. The PNECsediment is derived from the lowest available NOEC/EC10 obtained in long-term tests by application of the following assessment factors (Table 19): Table 19 Assessment factors for derivation of PNECsed Available test result Assessment factor One long-term test (NOEC or EC10) 100 Two long-term tests (NOEC or EC10) with species representing different living and feeding conditions 50 Three long-term tests (NOEC or EC10) with species representing different living and feeding conditions 10 3.6 EFFECTS ASSESSMENT FOR THE TERRESTRIAL COMPARTMENT 3.6.1 Introduction Chemicals can reach the soil via several routes: application of sewage sludge in agriculture, direct application of chemicals and deposition from the atmosphere. Consequently the possibility of adverse effects has to be assessed. The proposed strategy in this section is based on assessing the effects of chemicals on soil organisms. At the moment no strategy is available to assess possible effects on soil functions such as filtration, buffering capacity and metabolic capacity. 114
EFFECTS ASSESSMENT As mentioned in the introduction, the substances discharged into the soil can not only affect the soil organisms but also can influence soil functions. Substances that are hydrophilic and that are readily eluted with the rainwater into the ground water as well as those that geo-accumulate and those that are poorly degradable in soil should be considered with special care. If the substance is a biocide directly applied/emitted to soil, then the methodology referred in the Technical Notes for Guidance in support of Directive 98/8 concerning the placing of biocidal products on the market is recommended (http://ecb.jrc.it/biocides/). The terrestrial ecosystem comprises of an above-ground community, a soil community and a groundwater community. In this section only effects on soil organisms exposed directly via pore water and/or soil are addressed. It is recognised that the strategy described here must therefore be regarded as provisional. However, reference is made to the strategy for the air compartment (Section 3.7) and for bioaccumulation and secondary poisoning of birds and mammals (Section 3.8). It is currently not possible to carry out effect assessment for the groundwater community because no toxicity data are available. However, ecotoxicity tests with groundwater fauna and microflora have been proposed by Notenboom and Boessenkool (1992) and Van Beelen et al. (1990). The strategy described below is based on several documents relating to terrestrial effects assessment: OECD (1989), Stavola (1990), Samsøe-Petersen and Pedersen (1994), UBA (1993) and Römbke et al. (1993). 3.6.2 Strategy for effects assessment for soil organisms Standardised methods exist for the soil compartment but toxicity tests with terrestrial organisms are not yet included in a base set. For new substances toxicity tests with plants and earthworms can be requested at level 1. At level 2 there are, as yet, no specific additional requirements to examine effects on soil organisms. For existing substances data will probably be scarce: for most chemicals the data set will consist of results from short-term tests with for example earthworms and plants. Long-term tests methods are available (e.g. springtails and earthworms) but results from these tests are seldom available for existing substances. For biocides, toxicity tests with terrestrial organisms may be required depending on product type and expected use. The equilibrium partitioning method can be applied to aquatic data to identify a PNEC for soil organisms. However, this method cannot replace toxicity data for soil organisms and should only be considered as a screen for identifying substances requiring further testing. In common with the aquatic compartment, the objective of the assessment is to identify substances that present an immediate or delayed danger to the soil communities. Soil is a complex and heterogeneous medium in which biological processes are occurring. Microorganisms play an important role in degradation processes and the mineralisation of organic matter, allowing nutrients to be re-cycled in the ecosystem. Soil invertebrates are contributing to the recycling of elements and play a significant part in creating and maintaining a good soil structure. Finally, plants are primary producers and provide food for all other heterotrophic organisms. Consequently, the protection of the soil community requires protection of all organisms playing a leading role in establishing and maintaining the structure and the functioning of the ecosystem. The use of results from tests that represent different and significant ecological functions in the soil ecosystem is therefore suggested. 115
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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
Page 71 and 72: Explanation of symbols ENVIRONMENTA
Page 73 and 74: ENVIRONMENTAL EXPOSURE ASSESSMENT I
Page 75 and 76: ENVIRONMENTAL EXPOSURE ASSESSMENT d
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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
Page 85 and 86: ENVIRONMENTAL EXPOSURE ASSESSMENT W
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 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
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Page 121: In the partitioning method, it is a
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
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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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