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APPENDIX IX these “blocks” will not contribute to chronic toxic effects. There may be several approaches to estimate chronic toxicity for such chemicals if there are no measured long-term toxicity data available: • use the QSAR for long-term toxicity as presented in Chapter 4 of the TGD. However, these QSARs can only be applied in a range of log Kow from approximately 2-6. For chemicals with higher log Kow the resulting NOEC is often higher than the water solubility. • for blocks which do not demonstrate acute toxicity at or below their water solubility, QSARs (irrespective of the fact that the result may exceed the water solubility) may be used as a basis for the PNEC by application of a suitable assessment factor. This calculated value is taken to represent the PNEC of the block unless, it is itself greater than the water solubility. In this case the water solubility should be substituted as the PNEC. It should be noted that for very high log Kow values, this may lead to unrealistic PNEC values; • as an indication above log Kow 6, a parabolic equation to derive a BCF for fish can be used (see Section 3.8.3.2 of main text and Chapter 4) in combination with the critical body burden concept (McCarty & Mackay, 1982) to calculate the chronic toxicity. This critical body burden concept indicates that the long-term critical body burden is equal to the NOEC multiplied by the BCF (CBB = BCF .NOEC) (Sijm et al., 1992; ECETOC, 1995). To be able to perform a risk assessment, there may be a need to develop measured chronic data to support this QSAR prediction. Undissolved material Petroleum substances (or components of them) can enter the aquatic environment either in solution or as undissolved material in slicks or dispersions. Hydrocarbons in undissolved form might have direct local effects. It is considered that undissolved hydrocarbons will not be present at the regional level, but in any event this will have to be confirmed by calculating the PECregional. Monitoring data For substances consisting of only a single component sound and relevant monitoring data may be available for several compartments. For petroleum substances there are a number of difficulties related to the use of monitoring data that need specific consideration. Frequently there will be measurements of total hydrocarbons or of particular hydrocarbon components that may have come from a range of different petroleum substances. Such release or monitoring data may be used to provide a worst-case estimate of the concentration of a “block” for screening purposes, assuming that the whole of the release is attributable to the particular petroleum substance. However, it should be noted that the measured concentrations represent the sum of all sources of a block whereas the calculated concentrations for a specific “block” represents only the fraction of the total concentration of this “block” in the environment related to the specific petroleum substance under study. Therefore, monitoring data are most suitable for the assessment of a certain “block”, as they represent the actual concentration the organisms are exposed to in the environment, related to all relevant sources. Compartments other than the aquatic The description of the use of the HBM for the environmental risk assessment of petroleum substances given above, has focused on the aquatic environment. This is because at the present time it is only for this environmental compartment that sufficient data and experience are 316
APPENDIX IX available to allow anything approaching a full risk assessment. However, the principles of the HBM are applicable to all environmental compartments and it is anticipated that as familiarity with the approach extends, knowledge will increase and it will prove possible to apply it to the soil and air compartments. Particular shortcomings in relation to its wider application at the present time are the lack of data on the toxicity of chemicals, including hydrocarbons, to terrestrial organisms and hence the absence of adequate (Q)SARs. Contribution of computer based risk assessment to the use of the HBM The use of computer based risk assessment provides the capability to carry out many iterations of the risk characterisation which in turn facilitates: • investigation of effects of compositional changes; • investigation of alternative “blocking” schemes; • identification of blocks which are the principal contributors to the PEC/PNEC ratio for the whole substance and therefore, where most refinement of the data, through for example the generation of experimental values as opposed to (Q)SAR estimates would be most valuable; • maintenance of a data base of information on “blocks” which are common to more than one petroleum substance. Testing strategies Based on the identification of the blocks, the estimation of the block properties and the compositional information in combination with exposure scenarios a PEC/PNEC is calculated. If this PEC/PNEC is > 1, the general guidance concerning testing strategy as presented in Section 5 of the main text will be followed. Further refinement of the PEC or PNEC may be necessary in order to improve the data estimates for the properties of the blocks. A form of “sensitivity analysis” may be useful in confirming the selection of blocks to represent a particular petroleum substance; this approach may also be used to identify those particular parameters which are important in defining the fate and effects of the block. This approach may be useful to identify the most relevant additional data that would influence the outcome of the risk assessment. Further refinement of the data estimates for the block properties should be made when: • specific blocks have PEC/PNEC values > 1 or; • the total sum of the blocks results in a PEC/PNEC ratio > 1. For the blocks with a PEC/PNEC ratio > 1, one or some representative components should be selected. For these component(s) the testing principles from the TGD can be followed and the results can be used as representative for the specific block. If the combination of blocks with individual PEC/PNECs < 1 gives a PEC/PNEC > 1 it is suggested to focus on the major contributing blocks. For the relevant blocks again representative components can be selected and the general testing principles applied. Application of the method to other UVCBs It is apparent that this method may be applicable to other UVCB substances, but this will need to be explored on a case-by-case basis. Its broader applicability will be determined by the ability to define acceptable “blocks” and to provide the necessary data to support the derivation of PECs 317
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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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