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MARINE RISK ASSESSMENT 4.4.5 Testing strategy for the T criterion 4.4.5.1 Introduction For persistent and bioaccumulative substances long-term exposure can be anticipated and expected to cover the whole life-time of an organism and even multiple generations. Therefore chronic or long-term ecotoxicity data, ideally covering the reproductive stages should in principle be used for the assessment of the T criterion. In practice, however, the principal data available for most chemicals will be for short-term effects, and this must, in the first instance, be used to drive initial selection. Mammalian toxicity data must also be considered in the selection due to the fact that toxic effects on top predators, including man may occur through long-term exposure via the food-chain. The selection criteria should therefore consider two types of effect data, either of which will trigger selection. 4.4.5.2 Chronic effects data A substance is considered to fulfil the toxicity criterion when: • the long-term NOEC for marine or freshwater organisms is less than 0.01 mg/l. When other information is available such as data on sediment toxicity or data from feeding studies this needs to be assessed on case-by-case basis. For biocides and pesticides results from subchronic, chronic or reproduction avian toxicity tests may be available. A chronic NOEC of less than 30 mg/kg/food can be used as a criterion. or • when the substance is classified as Carcinogenic, (category 1 & 2), Mutagenic (category 1 & 2) or Toxic for Reproduction (category 1, 2 & 3) or when there is evidence of chronic toxicity, as identified by the classifications T, R45, R46, R48, R60 and R61 or Xn, R48, R62, R63 and R64 8. • when a substance is classified as Carcinogenic category 3 or Mutagenic category 3 a caseby-case assessment must be carried out to decide whether the evidence is sufficient for the substance to be considered as toxic, in the context of this PBT assessment, or whether further information is needed to clarify this potential concern. or • when there is substantiated evidence of long-term toxicity (e.g. endocrine disrupting effects). Such evidence needs to be considered on a case-by-case basis. 4.4.5.3 Acute effects data (screening level) Where data on chronic effects are not available short-term toxicity data for marine or freshwater organisms can be used to determine whether a substance is a potential PBT provided the screening criteria for P and B are fulfilled. In the context of the PBT assessment a substance is considered to be potentially toxic when the L(E)C50 to aquatic organisms is less than 0.1 mg/l. If a substance is confirmed to fulfil the ultimate P and B criteria chronic toxicity data are 8 In relation to the use of R64 in the context of the PBT assessment care should be taken that the actual assignment of the R-phrase is a result of results of one or two generation studies in animals which indicate the presence of adverse effects on the offspring due to transfer in the milk (see Annex VI to Directive 67/548). 170
MARINE RISK ASSESSMENT required to deselect this substance from being considered as a PBT. In principle chronic toxicity data, when obtained for the same species, should override the results from the acute tests. In the context of the PBT assessment acute mammalian toxicity tests are normally not considered to provide an appropriate indication of chronic effects. However, it should be noted that when a substance is classified as Very Toxic or Toxic after oral dosing (LD50 < 200 mg/kg bw/d) and the toxicity is expected to be the result of systemic effects, the probability that the chronic NOAEL after repeated dosing (e.g. 28 d or 90 d) will be less than the trigger value for R48 (± 150 or 50 mg/kg bw/d, respectively) will be high. The substance would therefore be classified and considered as fulfilling the T criterion. In that case verification of the actual chronic toxicity by performing animal testing is not recommended. When the P and B screening criteria are also fulfilled the substance can be considered as a PBT unless additional information indicates otherwise. 4.4.5.4 Estimated effects data In case where no acute or chronic toxicity data are available the assessment of the T criterion at a screening level can be performed using data obtained from quantitative structure activity relationships (QSARs). Guidance on the use of QSARs for specific groups of substances can be found in Chapter 4. It must be noted that since long-term effects can be anticipated for very bioaccumulative substances (vPvB), further animal testing for such substances is deemed unnecessary. 171
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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
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
Page 169 and 170: MARINE RISK ASSESSMENT • a measur
Page 171 and 172: MARINE RISK ASSESSMENT b. the conce
Page 173 and 174: MARINE RISK ASSESSMENT mechanisms s
Page 175 and 176: MARINE RISK ASSESSMENT The use of t
Page 177: 4.4.4.2 Assessment of measured BCF
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 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
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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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