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TESTING STRATEGIES 6.3 REFINEMENT OF PNEC: STRATEGY FOR FURTHER TESTING 6.3.1 Introduction A detailed strategy for further testing in order to refine the PNEC has been developed for the aquatic compartment. Guidance for deciding on further testing requirements although less specific than for the aquatic environment, is also provided for the sediment and terrestrial compartments and for secondary poisoning. Long-term tests are considered most applicable since a PNEC based on long-term ecotoxicity data is more reliable than a PNEC based on shortterm data. The additional tests lead to lower assessment factors due to the lower uncertainty. These strategies are described in detail within the discussion on the effects assessment (Section 3) under the relevant compartment. Refinement of the PNECwater for the aquatic compartment can be carried out by performing longterm tests with the most sensitive species or, if one or two NOEC(s) is/are already available, with a long-term test on species of trophic levels for which no NOEC was determined so far. The decision taking process can be supported by the use of (Q)SARs. The testing strategy is described in Section 6.3.2. The testing strategy proposed for the sediment compartment is described in Section 6.3.3. The risk assessment concept for the terrestrial compartment includes also a strategy for deciding when to carry out short-term toxicity tests on terrestrial organisms. Short-term tests are not included in the base-set but should be conducted, if a potential risk to soil has been identified on the basis of a risk characterisation using the equilibrium partitioning method. Expert judgement is required to decide on the most appropriate long-term test(s) if it is considered necessary to refine the PNECsoil (see Section 6.3.4). While any possible refinement of the PECoral/PNECoral ratio for secondary poisoning targets more the refinement of the PECoral rather than of the PNECoral, it may in some cases be more appropriate to refine the latter and conduct long-term or chronic toxicity tests. The decision on which test to conduct has to be taken on a case-by-case basis. No internationally accepted standardised test guidelines and/or no adequate effects assessment methods are available at present for the air compartment. Consequently no testing strategy is proposed. If it is concluded that this compartment is at risk a decision will have to be taken on a case-by-case basis. 6.3.2 Aquatic compartment 6.3.2.1 Introduction In the event that the PECwater/PNECwater ratio is greater than one, either exposure data have to be refined or further testing specified. One or more additional tests may have to be performed in accordance with methods specified in Annex V to Directive 67/548 or in OECD guidelines (or equivalent test guidelines). The methods used must be appropriate to a refined risk assessment. Only those tests yielding results that may lead to a revision of the PNECwater should be performed. Under some circumstances it might be appropriate to consider a mesocosm or (semi) field test that assesses sensitive and ecosystem-specific endpoints that are different from those assessed in single-species tests. 184
TESTING STRATEGIES Care must be taken, when attempting to revise the effects assessment by conducting additional aquatic toxicity testing, to ensure that species sensitivity is fully taken into account. Although the choice of tests is necessarily limited, it must reflect the anticipated exposure conditions and the chemical properties of the substance. In determining whether additional testing is required, the following guidelines should be followed: • additional testing should lead to a revision of the estimated PNECwater which, when based on long-term ecotoxicity data, is more reliable than the PNECwater when based on short-term data; • the species with the lowest L(E)C50 in short-term studies should normally be examined first for the purposes of long-term testing. Differences in L(E)C50s can be determined by comparing their values: one value is considered to be significantly lower than another if it is more than ten times lower. However, these definitions can only provide a guide to the relative sensitivities of taxonomic groups. Expert judgement must therefore be used to determine whether they are sufficient in any given case; • further testing would not normally be required on a species for which no short-term toxicity has been demonstrated (L(E)C50 > 100 mg/l). This may not apply to poorly water-soluble substances (water solubility < 1 mg/l) for which no short-term toxicity may have been demonstrated (see Section 5.6). In other cases, expert judgement should be used to determine whether further testing of a species is necessary. For substances that have a potential to bioaccumulate, it should be recognised that long-term or delayed effects are possible. These effects might not have been apparent or predicted from the results of short-term studies or long-term tests appropriate for non-bioaccumulating substances. This is considered to be of particular importance when considering long-term fish and Daphnia toxicity since several sensitive stages of their development can be affected because of their high lipid content in the early stages of their life-cycles. Care needs to be taken, therefore, to ensure that the appropriate long-term test is selected and that steady state concentrations are achieved in the organisms for a period that is sufficient to allow the potential effects of bioaccumulation to be investigated. Normally a Fish Early Life Stage test (OECD 210, 1984g) would be considered appropriate for examining fish toxicity. However, the fish, juvenile growth test (EU Annex V C.14) (for substances with log Kow < 5) or egg and sac-fry stage test (EU Annex V C.15) (for substances with log Kow < 4) may also be considered. The results from these long-term toxicity tests cannot exclude the possibility of delayed effects. When such effects are suspected, it may be appropriate to consider full life-cycle tests for fish according to the US EPA guidelines 670/4-73-001 (US EPA, 1973) or 600/9-78-010 (US EPA, 1978) and/or Daphnia (A guideline for a full life-cycle test for Daphnia is not available yet). Such testing would not be regarded as normal and should be necessary only in exceptional circumstances. Not all endpoints (such as multi-generation effects or behavioural disturbances) are assessed using these tests and biomagnification processes can hardly be reproduced in laboratory scale experiments. Consequently, even with this information, delayed effects in the ecosystems cannot be ruled out. 185
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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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Page 143 and 144: MARINE RISK ASSESSMENT environment
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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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Page 177 and 178: 4.4.4.2 Assessment of measured BCF
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Page 181 and 182: Table 33 Overview of PEC/PNEC ratio
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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: TESTING STRATEGIES Performance of a
Page 195 and 196: Algal testing Algae toxicity test (
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
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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
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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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