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EFFECTS ASSESSMENT for ciliates are considered to be supplementary to the data for activated sludge or specific bacteria, i.e. no correlation exists between activated sludge and ciliate test results, neither are ciliates consistently more sensitive. The data from one ciliate species are representative for other ciliates, i.e. test data from species not dominant or not present in STPs can serve as basis for the PNEC-derivation. The function of the protozoa in STP is correlated to their growth. Therefore, values from ciliate growth inhibition tests, preferably with Tetrahymena (cf. OECD, 1998a), are relevant for the risk assessment for STPs. Tests using other characteristics (e.g. ciliary motion, cell movement, etc.) should not serve as a basis for the PNEC-derivation. Often information may also be present on individual bacterial species such as from tests with Vibrio fischeri (used in the MICROTOX test), Pseudomonas putida, Pseudomonas fluorescens and even Escherichia coli. These tests must be considered as less relevant. The tests with P. fluorescence and E. coli (Bringmann and Kühn, 1960) cannot be used for determination of the PNECmicroorganisms as they use glucose as a substrate. Likewise, the MICROTOX test cannot be used as it uses a saltwater species. Results of the cell multiplication inhibition test with P. putida (Bringmann and Kühn, 1980) should only be used for calculation of the PNECmicroorganisms in cases where no other test results employing mixed inocula are available. In general, the aim of the assessment is the protection of the degradation and nitrification functions and process performance and efficiency of domestic and industrial STPs – as also influenced by protozoan populations. The toxicity of a substance to microorganisms in a STP is assessed by comparing the concentration of a substance in STP aeration tank with the microbial effect concentration data for that substance (see also Section 2.3.7.1). If the substance under consideration is relevant for industrial and municipal STPs the toxicity assessment should be conducted for both kinds of STPs separately. A PNECmicroorganisms should be obtained as a first step in the effects assessment for microorganisms in both domestic and industrial sewage treatment plants. The PNECmicroorganisms is usually derived from results obtained in the most sensitive test system available, regardless of whether this is a test with activated sludge, relevant bacteria or ciliated protozoa: • the PNECmicroorganisms is set equal to a NOEC from a test performed with ‘specific bacterial populations’ like nitrifying bacteria or P. putida or from a growth inhibition test performed with ciliated protozoa. An EC50 from this test is divided by an assessment factor of 10; • a NOEC or EC10 from other test systems like the respiration inhibition test (EU Annex V C.11; OECD 209, 1984f) is divided by an assessment factor of 10. An EC50 from this test is divided by an assessment factor of 100; • the lowest value is selected as the PNECmicroorganisms. There may be cases in which the lowest PNECmicroorganisms does not correspond to the effect value of the most sensitive test system because different AF (100 or 10) are applied to the different test systems. In these cases expert judgement should be used to decide which effect value is appropriate for the calculation of the PNECmicroorganisms. Usually the effect value of the most sensitive test system should be used as a basis for the calculation of PNECmicroorganisms employing the appropriate AF. Table 17 provides a complete listing of the test systems mentioned above, effect concentrations that are determined using them and the corresponding assessment factors. 108
Table 17 Test systems for derivation of PNECmicroorganisms EFFECTS ASSESSMENT Test Available value Assessment factor Respiration inhibition tests NOEC or EC10 10 EU Annex V C.11; OECD 209 (1984f) ISO 8192 (1986) Inhibition control in standardised biodegradation tests - Ready biodegradability tests EU Annex V C.4 A-F; OECD 301A-F (1992f) 92/69/EEC C4 (1992) ISO-7827 (1994), -9439 (1999), -10707 (1994), -9408 (1999) - Inherent biodegradability tests EU Annex V C.9; OECD 302 B-C (1981d-1992g) 88/302/EEC (1988) ISO-9888 (1999) EC50 100 The tested concentration at which toxicity to the inoculum can be ruled out with sufficient reliability (cf. corresponding text section above) could be considered as a NOEC for the toxicity to microorganisms of a STP Inhibition of nitrification NOEC or EC10 1 ISO-9509 (1989) EC50 10 Ciliate growth inhibition tests NOEC or EC10 1 (preferably with Tetrahymena, cf. OECD, 1998a) 1) EC50 10 Activated sludge growth inhibition tests NOEC or EC10 10 ISO-15522 EC50 100 Pilot scale activated sludge simulation tests OECD 303A (2001b) ISO-11733 Based on case-by-case expert judgement, the tested concentration not impairing proper functioning of the CAS 2) unit could be considered as NOEC for microorganisms in STPs 10 Case-by-case down to 1 Growth inhibition test with Pseudomonas putida NOEC or EC10 1 NF EN ISO 10712 (1995) EC50 10 (Bringmann and Kühn, 1980) to be used if no other tests are available Pseudomonas fluorescens (Bringmann and Kühn, 1960) Escherichia coli (Bringmann and Kühn, 1960) Vibrio fischeri (MICROTOX) NF EN ISO 11348-1, -2, -3 (1999) Notes to Table 17: 1) Ciliate testing would be required as the guideline becomes available 2) CAS: Continuous Activated Sludge Not usable as it uses glucose as substrate Not usable as it uses glucose as substrate Not relevant for STP as the bacterium is a saltwater species 109
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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 T
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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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Page 69 and 70: Primary Settler Aeration Tank 2 5 3
Page 71 and 72: Explanation of symbols ENVIRONMENTA
Page 73 and 74: ENVIRONMENTAL EXPOSURE ASSESSMENT I
Page 75 and 76: ENVIRONMENTAL EXPOSURE ASSESSMENT d
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Page 79 and 80: 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
Page 85 and 86: ENVIRONMENTAL EXPOSURE ASSESSMENT W
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: EFFECTS ASSESSMENT biodegradability
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 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
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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 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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