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EFFECTS ASSESSMENT • has a log Kow ≥ 3; or; • is highly adsorptive; or; • belongs to a class of substances known to have a potential to accumulate in living organisms; or; • there are indications from structural features; • and there is no mitigating property such as hydrolysis (half-life less than 12 hours); there is an indication of bioaccumulation potential. Reference is made to the OECD guidelines and to the guidance document on environmental hazard classification (OECD, 2001c) in relation to interpretation of bioaccumulation studies and measurements of logKow. The test guidelines also contain information on the suitability of the various log Kow determination methods depending on the type of substance concerned. 3.8.3 Effects assessment for bioaccumulation and secondary poisoning 3.8.3.1 General approach The assessment of the potential impact of substances on top predators is based on the accumulation of hydrophobic chemicals through the food chains which may follow many different pathways along different trophic levels. This accumulation may result in toxic concentrations in predatory birds or mammals ingesting biota containing the chemical. This effect is called secondary poisoning and should in principle be assessed by comparing the measured or estimated concentrations in the tissues and organs of the top predators with the noeffect concentrations for these predators expressed as the internal dose. In practice, however, data on internal concentrations in wildlife animals are hardly ever available and most no-effect levels are expressed in term of concentrations of the food that the organisms consume (i.e. in mg .kg -1 food). Therefore, the actual assessment (see below) is normally based on a comparison of the (predicted) concentration in the food of the top predator and the (predicted) no-effect concentration which is based on studies with laboratory animals. A distinction is made between the methodology used to assess the effects of substances whose effects can be related directly to bioconcentration (direct uptake via water) and those where also indirect uptake via the food may contribute significantly to the bioaccumulation. Bioaccumulation of metallic species is not considered explicitly in this section. For substances with a log Kow < 4.5 the primary uptake route is direct uptake from the water phase. In the absence of data on other uptake routes, it is assumed that the direct uptake accounts for 100% of the intake. For substances with a log Kow ≥ 4.5, other uptake routes such as intake of contaminated food or sediment may become increasingly important. Especially the uptake through the food chains eventually leading to secondary poisoning should be considered and a strategy for the assessment of secondary poisoning has been developed. This strategy takes account of the PECaquatic, the direct uptake and resulting concentration in food of aquatic organisms and the mammalian and avian toxicity of the chemical. On this basis, possible effects are estimated on birds and mammals in the environment via uptake through the food-chain water → aquatic organisms → fish → fish-eating mammal or fish-eating bird (Romijn et al., 1993). Due to the lack of experience with this approach the assessment is considered as provisional. 124
EFFECTS ASSESSMENT For some chemicals results from field measurements are available. Although interpretation is often difficult, these results can be used to support the assessment of risks due to secondary poisoning (Ma, 1994). The first step in the assessment strategy is to consider whether there are indications for bioaccumulation potential. These indications have been discussed in the previous section. Subsequently, it is necessary to consider whether the substance has a potential to cause toxic effects if accumulated in higher organisms. This assessment is based on classifications on the basis of mammalian toxicity data, i.e. the classification Very Toxic (T+) or Toxic (T) or harmful (Xn) with at least one of the risk phrases R48 “Danger of serious damage to health by prolonged exposure”, R60 “May impair fertility”, R61 “May cause harm to the unborn child”, R62 “Possible risk of impaired fertility”, R63 “Possible risk of harm to the unborn child”, R64 “May cause harm to breastfed babies”. Here it is assumed that the available mammalian toxicity data can give an indication on the possible risks of the chemical to higher organisms in the environment. The current, either qualitative or quantitative, approach in the human health risk assessment for genotoxic carcinogens is not practicable in the environmental part. Tumor incidence rates for a genotoxic carcinogen and subsequent cancer risks are related to individual risks in man and it is in most cases difficult to link those effects to populations. Endangoured species might be an exception, particularly those characterized by long-life-cycles where individuals may need to be protected to support survival of the species. It is not unlikely, however, that the conservative approach followed in the risk assessment for man indirectly exposed via the environment for genotoxic substances, will also be protective for individual top predators. If a substance is classified accordingly or if there are other indications (e.g. endocrine disruption), an assessment of secondary poisoning is performed. A schematic view of the assessment scheme for the exposure route water → aquatic organisms → fish → fish-eating mammal or fish-eating bird described above is given in Figure 14. Water Aquatic organism Figure 14. Assessment of secondary poisoning Fish PECoral,predator from BCF & BMF Fish-eating predator No specific assessment of the risk to fish as a result of the combined intake of contaminants from water and contaminated food (aquatic organism) is considered necessary as this is assumed to be covered by the aquatic risk assessment and the risk assessment for secondary poisoning of fisheating predators. The risk to the fish-eating predators (mammals and/or birds) is calculated as the ratio between the concentration in their food (PECoralpredator) and the no-effect-concentration for oral intake (PNECoral). The concentration in fish is a result of uptake from the aqueous phase and intake of contaminated food (aquatic organisms). Thus, PECoralpredator is calculated from the bioconcentration factor (BCF) and a biomagnification factor (BMF). Note that PECoralpredator could also be calculated for other relevant species that are part of the food of predators. The details of the individual assessment steps are described in the following sections. 125
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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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Explanation of symbols ENVIRONMENTA
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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
Page 81 and 82: ENVIRONMENTAL EXPOSURE ASSESSMENT -
Page 83 and 84: 2.3.8.3 Calculation of PEClocal for
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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
Page 119 and 120: EFFECTS ASSESSMENT representative o
Page 121 and 122: In the partitioning method, it is a
Page 123 and 124: EFFECTS ASSESSMENT As mentioned in
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: EFFECTS ASSESSMENT bioaccumulation
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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 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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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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