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APPENDIX XI Appendix XI Environmental risk assessment for ionising substances Introduction The degree of ionisation of an organic acid or base greatly affects both the fate and the toxicity of the compound. The water solubility, the adsorption and bioconcentration, as well as the toxicity of the ionised form of a substance may be markedly different from the corresponding neutral molecule. When the dissociation constant (pKa/pKb) of a substance is known, the percentage of the dissociated and the neutral form of the compound can be determined. For example, for an acid with a pKa of 5.5, the pH dependency of the behaviour of the substance can be described as follows: • 1% dissociated at pH 3.5; • 10% dissociated at pH 4.5; • 50% dissociated at pH 5.5; • 90% dissociated at pH 6.5; • 99% dissociated at pH 7.5. Thus, even slight changes in the pH of the environment considerably affect the form in which the substance is present in the environment. This is the case especially for substances with pKa/pKb values around the pH values of the environment (i.e. pH 4-9 for surface water). In the assessment of ionised substances, due attention has to be paid as to how much fate and effects of the substance are affected by the pH of the environment. Exposure assessment The water solubility of organic acids and bases are very much dependent on the pH. The water solubility of the dissociated compound can be orders of magnitude higher than the neutral species. Therefore, the pH dependence of the water solubility should be known. At least the pH of the test water needs to be identified. This also applies to log Kow. The basic parameters used in the exposure assessment (log Kow, Henry's law constant, adsorption/desorption coefficients) are only applicable to the non-ionised form of the substance. Therefore, every time when partitioning of a substance between water and air or solids is concerned, a correction needs to be made in order to take only the undissociated fraction of the compound into account at a given pH. In practice, this implies that Henry's law constant and Kp in soil, sediment, and suspended solids need to be corrected. This can be done by using the following correction factor: 320 CORR = where: A 1 for acids, -1 for bases pH pH-value of the environment pKa acid/base dissociation constant 1 A 1+ 10 (pH - pKa) The above correction can only be used for partitioning coefficients which refer to the unionised form of the substance. This means that for estimated partitioning coefficients, water solubility
APPENDIX XI and Kow need to be determined for the neutral form. The choice of relevant pH values to be used in the calculation should be based on the pKa/pKb of the compound in concern and any relevant knowledge of the actual toxic form of the substance. For experimentally determined partition coefficients the need for correction should be assessed on a case by case basis, depending on the pH in the test. These principles apply also to the fate of the substance in sewage treatment plant. However, since the STP is a well buffered environment, a default pH of 7 can be used in the calculations. The role of pH in the experimental determination of the bioconcentration should also be acknowledged. Effects assessment Ionisation can markedly alter the toxicity of the substance. Normally, this is caused by the different bioavailability of the dissociated and neutral species. Consequently, when testing toxicity, the tests should preferably be carried out at both sides of the pKa, to fully characterise the possible differences in toxicity. Since this may not be possible in every case, the role of pH should at least be discussed qualitatively in the assessment. Risk characterisation Care should be taken that the PEC and the PNEC in the risk characterisation represent similar conditions. PEC/PNEC comparisons should preferably be made at both sides of the pKa values, within environmentally relevant pH-range. The higher PEC/PNEC ratio should be used in the risk characterisation, following the realistic worst-case approach. If it is not possible to carry out a quantitative analysis, the assessor should take the pH effect into account qualitatively. 321
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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
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4.2.3.3 Marine biodegradation simul
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MARINE RISK ASSESSMENT In addition
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Explanation of symbols MARINE RISK
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MARINE RISK ASSESSMENT evaluate the
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MARINE RISK ASSESSMENT marine water
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MARINE RISK ASSESSMENT The addition
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MARINE RISK ASSESSMENT Statistical
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MARINE RISK ASSESSMENT sediment, fo
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Table 27 Assessment factors for der
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Table 28 continued Acute and chroni
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MARINE RISK ASSESSMENT of different
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MARINE RISK ASSESSMENT • a measur
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MARINE RISK ASSESSMENT b. the conce
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MARINE RISK ASSESSMENT mechanisms s
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MARINE RISK ASSESSMENT The use of t
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4.4.4.2 Assessment of measured BCF
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MARINE RISK ASSESSMENT required to
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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 No. Use Category No. Fun
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