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TESTING STRATEGIES 6.3.2.2 Available long-term tests The long-term tests available when seeking to refine the PNEC are limited. It is nevertheless important that the correct test is chosen to maximise the usable information and avoid unnecessary repeat testing. Long-term fish testing Fish early-life stage(FELS) toxicity test (OECD 210, 1992h) A full life-cycle fish test is not currently available as standardised test method. In its absence the FELS toxicity test is considered as the most sensitive of the fish tests, covering several life stages of the fish from the newly fertilised egg, through hatch to early stages of growth. This is considered to cover most, but not all, of the sensitive points in the life-cycle and is also the only suitable test currently available for examining the potential toxic effects of bioaccumulation. It is, however, a long test, typically 60 days post-hatch for rainbow trout (Oncorhynchus mykiss), or approximately 30 days post-hatch for warm water fish, and is consequently the most expensive of those available. It should therefore only be requested where long-term fish toxicity data are required and the substance has the potential to bioaccumulate. Fish, short-term toxicity test on embryo and sac-fry stages (EU Annex V C.15, OECD 212, 1998c) This test measures the sensitive early life stages from the newly fertilised egg to the end of the sac-fry stage. It is considerably shorter, and hence less expensive, than the FELS toxicity test but is also considered less sensitive. The method offers an alternative to the FELS toxicity test for substances with log Kow less than 4. Fish, juvenile growth test (EU Annex V C.14, OECD 215, 2000d) This test measures the growth of juvenile fish over a fixed period, and is considered a sensitive indicator of toxicity. Although it is considered to be of insufficient duration to examine all the sensitive points in the fish life-cycle, it provides a shorter and less expensive option to the FELS test for substances of log Kow < 5. Fish, prolonged toxicity test, 14-day study (OECD 204, 1984c) This test cannot be considered a suitable long-term toxicity study since it does not examine a sensitive stage in the fish life-cycle. It is, in effect, a prolonged acute study with fish mortality as the major end-point examined. However, sub-lethal effects are monitored and the NOEC should be based on the absence of these effects. It should not be requested where a long-term fish study is required. It should only be requested where provision of further information on possible shortterm effects is considered necessary. Long-term Daphnia testing Daphnia magna reproduction test (EU Annex V C.20, OECD 211, 1998b) This test measures effects on juvenile production as well as parental immobility and mortality. It is frequently (and preferably) conducted over 21 days. Although it does not cover the full Daphnia life-cycle, it does cover the sensitive reproduction stage and is therefore considered a sensitive long-term study. 186
Algal testing Algae toxicity test (EU Annex V C3, OECD 201, 1984a) TESTING STRATEGIES The algal growth inhibition test measures the inhibition of growth during the exponential phase under optimum standard conditions of light, temperature and nutrient concentrations. The test produces an EC50 that can be considered equivalent to a short-term L(E)C50. Often both ErC50 (estimated from specific growth rate) and EbC50 (estimated from biomass growth) are available, however the latter should not be used. The reason is that direct use of the biomass concentration without logarithmic transformation cannot be applied to an analysis of results from a system in exponential growth. Where only the EbC50 is reported, but primary data are available, a reanalysis of the data should therefore be carried out to determine the ErC50. It is sometimes seen also when test was done according to standard test guidelines, that the exponential growth ceased in the control before the end of the test period. Likewise it may be seen that the validity criteria of the test were not fulfilled (pH increase etc.) or growth of the algae in the exposed concentrations was increased (due to e.g. loss of test substance from the test system) at the end of the test. In such cases only data from the part of the test where exponential growth and the validity criteria for the controls as well as for the exposed groups occurred should be used. In many such cases this may be achieved by excluding data from the last test day from the calculation of ErC50 and NOEC or ErC10. (Nyholm, 1985; Nyholm and Källqvist, 1989; Ratte, 1998; Weyers & Vollmer, 2000; Källquist; 1999, 2000; Weyers et al., 2000). If only EbC50 is reported and no primary data are available, it should be considered to perform a new algae study to obtain a valid ErC50 and NOEC or ErC10. The algal growth inhibition test is not only a multi-generation test but also provides a measure of sub-lethal effect - reduction in population growth. It can therefore be considered a true chronic test, albeit of short duration. The NOEC may therefore be used in the assessment strategy, but with some modification compared to NOECs from long-term chronic tests with fish or Daphnia (i.e. availability of a NOEC for algae alone is not used as a justification deviating from using the lowest L(E)C50-value from short-term studies). 6.3.2.3 Decision table for further testing The decisions to be made in respect of further testing requirements are detailed in Table 34. Although the basic criteria outlined above must always be taken into account, common sense must also be applied when considering individual situations. Decisions taken in respect of further testing will be different depending on species sensitivity. In all cases, the algal study from the base set is first considered as a short-term study and the EC50 used for calculation of the PNECwater. However, the algal study is technically a multi-generation test and thus, if there are other long-term NOEC data, the algal NOEC can be considered as a long-term NOEC in the revised assessment. Generally, this algal NOEC would not be used unsupported by other longterm data. Chapter 4 (Use of (Q)SARs) gives full details on the use within the testing strategy of the QSAR estimates for substances with a non-specific mode of action and for estimating long-term fish and Daphnia toxicity. 187
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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
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
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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: TESTING STRATEGIES Care must be tak
Page 197 and 198: TESTING STRATEGIES • long-term te
Page 199 and 200: Microbial assays TESTING STRATEGIES
Page 201 and 202: TESTING STRATEGIES A soil bioassay
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
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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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