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TESTING STRATEGIES during the test as this would lead to an underestimation of the toxicity. To limit such desorption an adequate equilibration period before the start of the test is recommended. In addition the actual concentration of the test substance in the sediment should be monitored at least at the beginning and at the end of the test to check the efficiency of the contamination technique and the stability of the test substance concentration. 6.3.4 Soil compartment At an initial stage and in respect to the current proceedings in the aquatic compartment, a minimum data set for risk assessment for soil organisms could be based on short-term toxic effects data. PECsoil/PNECsoil ratios are derived from either ecotoxicological data or the equilibrium partitioning method (see Section 3.6.2.). Two cases can be identified where it might be considered necessary to revise the PNECsoil,: (1) short-term tests on primary producers, consumers and decomposers should be performed if the equilibrium partitioning method is applied because of the absence of toxicity data for soil organisms and the PECsoil/PNECsoil is > 1. In some cases long-term tests might be preferred immediately when, for example, soil organisms or part of the life-cycle of a plant or microbial processes are suspected to be particularly sensitive to the test compound. This is especially true, if the substance in question exhibits a log Kow greater than 5 (equivalent to a log Koc > 4) or exhibits a corresponding binding behaviour; (2) further testing may be necessary if the PNECsoil is based on toxicity data for soil organisms using assessment factors and the PEC/PNECsoil > 1. Long-term tests should be considered in particular if the available PNECsoil is based on short-term effects. Depending on the effect that a substance has on vascular plants, earthworms or processes mediated by microorganisms, the information about the effect on the most sensitive organisms has to be improved by conducting appropriate tests for the respective endpoints. The choice of the test species will be made on a case-by-case basis taking into account the availability of a suitable test method, the sensitivity of aquatic and/or sediment living organisms that may be predictable for the sensitivity of equivalent groups of soil organisms, the indicative nature of the assessment factors and the uncertainty in the proposed approach. Internationally accepted methods (OECD and ISO) should preferably be used but results from other methods that are in the process of being standardised might also be appropriate. Several research programmes have been initiated that are aimed at the development of soil tests: the Netherlands Integrated Soil Research Programme (NISRP; Eijsackers, 1989) and the Swedish Mark Test System (MATS; Rundgren et al., 1989). More recently, ten European laboratories have formed a network (SECOFASE, Løkke and van Gestel, 1993) funded by the European Union to develop, improve and standardize tests systems for assessing sublethal effects of chemicals on fauna in soil ecosystems. As a result of this European research project, test protocols, indications on species sensitivities, reproducibility of the tests and also advice for the choice of test species has been published in the “Handbook of soil invertebrate toxicity tests” (Løkke and van Gestel, 1998). 190
Microbial assays TESTING STRATEGIES Microbial processes are considered as short-term tests. A NOEC from these tests could be considered as long-term results for microbial populations. Protozoans live mainly in the soil pore water and results from ciliate growth inhibition tests are relevant for the risk assessment for STPs (see Section 3.4.). Ecotoxicity tests with/on Protozoans will not be used for the risk assessment in the soil compartment unless specific assay have been developed for soil Protozoans. Determination of nitrogen mineralization and nitrification in soils and the influence of chemicals on these processes (draft EU Annex V C.21; OECD 216, 2000e; ISO 14238, 1997) Microorganisms use the soil organic matter to satisfy their own energy and nutrient requirements. Organic N is then mineralised to ammonia and oxidised to nitrate. The test is designed to determine the influence of a substance on the mineralization rate of a soil with a low organic carbon content that is representative of a worst case for the bioavailability of the substance. Nitrate concentration is measured in soils treated with the test substance after a 28 days incubation period. The result is compared to the nitrate concentration in a control and the degree of inhibition is calculated. Determination of carbon transformation activity (draft EU Annex V C.22; OECD 217, 2000f; ISO 14239, 1997) Under aerobic conditions ultimate degradation of organic matter by decomposer organisms leads to carbon dioxide formation. Respiration measurement is used to assess the activity of microbial populations. Carbon dioxide or oxygen uptake can be measured on soils that are incubated under controlled environmental conditions. Inhibition of mineralization is then determined. Determination of potential nitrification, a rapid test by ammonium oxidation (ISO/CD 5685, 2000) Ammonium oxidation is the first step in autotrophic nitrification in soil. The method is based on measurement of the potential activity of the nitrifying population as assessed by the accumulation of nitrite over a short incubation period. The method does not assess growth of the nitrifying population. Inhibitory doses are calculated. Determination of abundance and activity of the soil micro-flora using respiration curves (ISO/CD 17155, 2000) This method is used to assess the effect of chemicals on the soil microbial activity by measuring the respiration rate (CO2 production or O2 consumption). The chemicals may kill the micro-flora, reduce their activity, enhance their vitality or have no effect (either because the toxicity of the substances is low or some species are replaced by more resistant ones). EC10 and EC50 are determined when toxicity is observed. Invertebrate assays Ecotoxicity tests (but not necessarily standardised tests) exist for Nematodes, Annelids, Molluscs and Arthropods. Other invertebrate tests based on, for example, Annelids, Arthropods or other phyla could equally be used. Standardised tests that are currently available are described below. 191
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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
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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
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
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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
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: TESTING STRATEGIES • long-term te
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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
Page 226 and 227: APPENDIX I 1. extension of the tabl
Page 228 and 229: APPENDIX I 220 A-tables Estimates f
Page 230 and 231: APPENDIX I PRIVATE USE Not applicab
Page 232 and 233: APPENDIX I IC = 3: CHEMICAL INDUSTR
Page 234 and 235: APPENDIX I IC = 5: PERSONAL /DOMEST
Page 236 and 237: APPENDIX I Table A4.1 continued Com
Page 238 and 239: APPENDIX I IC = 7: LEATHER PROCESSI
Page 240 and 241: APPENDIX I IC = 9: MINERAL OIL AND
Page 242 and 243: APPENDIX I WASTE TREATMENT Table A5
Page 244 and 245: APPENDIX I For the emission factors
Page 246 and 247: 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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