technical guidance documents - Institute for Health and Consumer ...

More documents

Recommendations

Info

ENVIRONMENTAL EXPOSURE ASSESSMENT • they are only used for the water-dissolved fraction of the substance. Partitioning between water and sludge phases should be calculated prior to the application of the rate constant; • sufficiently valid data from internationally standardised tests are preferred; Data from non-standardised tests and/or tests not performed according to the principles of GLP may be used if expert judgement has confirmed them to be equivalent to results from the standardised degradation tests on which the calculation models, e.g. SimpleTreat, are based. The same applies to STP-measured data, i.e., in-situ influent/effluent measurements. Table 6 Elimination in sewage treatment plants: Extrapolation from test results to rate constants in STP model (SimpleTreat) 52 Test result Rate constant k . (h -1 ) Readily biodegradable a) 1 Readily, but failing 10-d window a) 0.3 Inherently biodegradable, fulfilling specific criteria b) 0.1 Inherently biodegradable, not fulfilling specific criteria b) 0 Not biodegradable 0 Notes to Table 6: a) Ready biodegradability testing (28 d) (92/69/ EU Annex V C.4 A-F, or respectively, OECD 301A-F (1992f) or equivalent according to expert judgement). Ready biodegradability tests are screening tests for identifying substances that, based on general experience, are assumed to undergo rapid and ultimate biodegradation in the aerobic environment. However, a negative result does not necessarily mean that the substance will not be biodegraded in, e.g., a sewage treatment plant. The degree of ultimate degradation may be followed by determination of the loss of dissolved organic carbon (DOC), the evolution of carbon dioxide or the amount of oxygen consumed. It is generally accepted that a substance is considered to be readily biodegradable if the substance fulfils the pass criteria of a test for ready biodegradability (cf. the Annex V methods or the OECD guidelines) which may include the concept of the 10 days time window as a simple kinetic criterion. All percentage biodegradation results refer to true biodegradation i.e. mineralisation excluding abiotic elimination processes (e.g. volatilisation, adsorption). This means that corresponding data in adequate control vessels must be generated during biodegradation testing. The test may be continued beyond 28 days if biodegradation has started but does not reach the required pass criteria for final mineralisation: in this case however, the substance would not be regarded as being readily biodegradable. If the substance reaches the biodegradation pass levels within 28 days but not within the 10-day time window, a biodegradation rate constant of 0.3 h-1 is assumed. In case that only old ready biodegradation test results (i.e. tests executed prior to the introduction of the 10 days time window criterion and documenting only on the pass level) are available a rate constant of 0.3 h-1 should be applied in case the pass level is reached. Based on weight of evidence (e.g. several old test results) a rate constant of 1 h-1 may be justified by expert judgement. If the substance is found to be not readily biodegradable, it is necessary to check whether it was inhibitory to microbial activity at the concentration used in the biodegradability test. If the substance is inhibitory, it may be re-tested at low, non-inhibitory concentrations in a test simulating the conditions in a sewage treatment plant (e.g. OECD guideline 303, 2001b; ISO 11733 or equivalent). If appropriate, re-testing in another more suitable ready biodegradability test (e.g. Closed Bottle test) may be considered. Re-testing in a modified ready biodegradability test at a much lower concentration (i.e. more than 10 times lower than prescribed) cannot generally be recommended because suitable simulation test methods are available. b) Inherent biodegradability testing (28d) (87/302/EEC, respectively, OECD 302B-C (1981d-1992g) or equivalent according to expert judgement). Inherent biodegradability tests are designed to assess whether the substance has any potential for biodegradation. A negative result will normally mean that non-biodegradability (persistence) should be assumed. A positive result, on the other hand, indicates that the substance will not persist indefinitely in the environment. In those cases where a more accurate prediction of degradation kinetics in treatment plants is required, sewage treatment plant simulation tests (e.g. OECD guideline 303, 2001b; ISO 11733 or equivalent) should be conducted. In tests for inherent biodegradability, the test conditions are designed to be more favourable to the microorganisms in that the ratio of substance to cells is lower than in the ready tests and there is no requirement for the (bio)degradation to follow a time pattern as in the ready tests. Also, pre-exposure of the inoculum resulting in pre-adaptation of the microorganisms may be allowed. The time permitted for the study is limited to 28 days, but it may be continued for much longer; 6 months has been suggested as the maximum duration for the test. The results obtained in a test of more than 28 days are not comparable with those obtained in less than this period. Usually, more than 70% (bio)degradation within 28 days indicates that the substance is inherently biodegradable. However, extrapolation of the results of the inherent tests should be done with great caution because of the strongly favourable conditions for biodegradation that are present in these tests. Therefore, a substance that passes an inherent test should in principle be given a rate
constant of zero. However, if it can be shown that: - The elimination in the test can really be ascribed to biodegradation, and; - No recalcitrant metabolites are formed, and; - The adaptation time in the test is limited; ENVIRONMENTAL EXPOSURE ASSESSMENT then a rate constant of 0.1 h-1 in the STP-model can be used. These qualitative criteria are transformed into the following more specific criteria that the different inherent biodegradation tests must fulfil: Zahn-Wellens test: Pass level must be reached within 7 days, log-phase should be no longer than 3 days, percentage removal in the test before biodegradation occurs should be below 15 %. MITI-II test: Pass level must be reached within 14 days, log-phase should be no longer than 3 days. No specific criteria have been developed for positive results in a SCAS test. A rate constant of 0 h-1 will be assigned to a substance, irrespective whether it passes this test or not. 2.3.6.5 Biodegradation in surface water, sediment and soil The rate of biodegradation in surface water, soil and sediment is related to the structure of substances, microbial numbers, organic carbon content, and temperature. These properties vary spatially and an accurate estimate of the rate of biodegradation is very difficult even if laboratory or field data are available. Fate and exposure models normally assume the following simplifications: • the kinetics of biodegradation are pseudo-first order; • only the dissolved portion of the substance is available for biodegradation. Normally, specific information on biodegradability in sediment or soil is not available. Hence, rate constants for these compartments have to be estimated from the results of standardised tests. In deeper sediment layers anaerobic conditions normally prevail. A prediction of anaerobic biodegradation from aerobic biodegradability is not possible. For testing of anaerobic biodegradation the ISO 11734 guideline is available (ISO 1995). This screening test method is designed to investigate the potential for anaerobic degradation in STP digesters. The assessment of biodegradation in surface waters, sediments and soil should, whenever possible, be based on results from tests simulating the conditions in the relevant environmental compartments. Temperature influences the activity of microorganisms and thus the biodegradation rate in the environment. When biodegradation rates or half-lives have been determined in simulation tests, it should be considered to recalculate the degradation rates obtained to reflect an average EU outdoor temperature by equation (25). When it is documented for a specific substance that a difference between the temperature employed in the test and the average outdoor temperature has no influence on the degradation half-life, no correction is needed. Preference of simulation tests also applies to estimation of degradation half-life in surface waters. The draft ISO/DIS 14952-1 standard on biodegradation of organic substances at low concentration in surface waters was agreed in 1999. The ISO method has been the basis for a proposal for a new OECD guideline “Simulation test – Aerobic mineralisation in surface water” (OECD, 2001d). It is foreseen that in future results from such tests may sometimes be available or required for risk assessment of high priority substances. An assessment of the applicability of such test results should always be conducted taking into account the prescribed standard conditions for surface waters applied in the risk assessment scenarios according to this TGD relative to the conditions employed in simulation tests. 53
Page 1:
Institute for Health and Consumer P
Page 4 and 5:
LEGAL NOTICE Neither the European C
Page 7:
OVERVIEW This Technical Guidance Do
Page 11 and 12: CONTENTS 1 GENERAL INTRODUCTION ...
Page 13 and 14: 4.2.3.4 Use of biodegradation scree
Page 15 and 16: 1 GENERAL INTRODUCTION 1.1 BACKGROU
Page 17 and 18: GENERAL INTRODUCTION countries in t
Page 19 and 20: GENERAL INTRODUCTION PNEC is regard
Page 21 and 22: 2 ENVIRONMENTAL EXPOSURE ASSESSMENT
Page 23 and 24: ENVIRONMENTAL EXPOSURE ASSESSMENT r
Page 25 and 26: 2.2 MEASURED DATA ENVIRONMENTAL EXP
Page 27 and 28: ENVIRONMENTAL EXPOSURE ASSESSMENT w
Page 29 and 30: ENVIRONMENTAL EXPOSURE ASSESSMENT o
Page 31 and 32: ENVIRONMENTAL EXPOSURE ASSESSMENT T
Page 33 and 34: ENVIRONMENTAL EXPOSURE ASSESSMENT r
Page 35 and 36: Production ENVIRONMENTAL EXPOSURE A
Page 37 and 38: Back to processing Product at end o
Page 41 and 42: ENVIRONMENTAL EXPOSURE ASSESSMENT s
Page 43 and 44: Explanation of symbols ENVIRONMENTA
Page 45 and 46: ENVIRONMENTAL EXPOSURE ASSESSMENT s
Page 47 and 48: ENVIRONMENTAL EXPOSURE ASSESSMENT U
Page 49 and 50: ENVIRONMENTAL EXPOSURE ASSESSMENT a
Page 51 and 52: ENVIRONMENTAL EXPOSURE ASSESSMENT F
Page 53 and 54: 2.3.5.1 Adsorption to aerosol parti
Page 55 and 56: ENVIRONMENTAL EXPOSURE ASSESSMENT I
Page 57 and 58: 2.3.6.1 Hydrolysis ENVIRONMENTAL EX
Page 59: 2.3.6.3 Photochemical reactions in
Page 63 and 64: ENVIRONMENTAL EXPOSURE ASSESSMENT A
Page 67 and 68: ENVIRONMENTAL EXPOSURE ASSESSMENT a
Page 69 and 70: Primary Settler Aeration Tank 2 5 3
Page 73 and 74: ENVIRONMENTAL EXPOSURE ASSESSMENT I
Page 75 and 76: ENVIRONMENTAL EXPOSURE ASSESSMENT d
Page 77 and 78: ENVIRONMENTAL EXPOSURE ASSESSMENT e
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 93 and 94: Calculation of PEClocalsoil For soi
Page 95 and 96: ENVIRONMENTAL EXPOSURE ASSESSMENT
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 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 and 178:
4.4.4.2 Assessment of measured BCF
Page 179 and 180:
MARINE RISK ASSESSMENT required to
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
Page 226 and 227:
APPENDIX I 1. extension of the tabl
Page 228 and 229:
APPENDIX I 220 A-tables Estimates f
Page 230 and 231:
APPENDIX I PRIVATE USE Not applicab
Page 232 and 233:
APPENDIX I IC = 3: CHEMICAL INDUSTR
Page 234 and 235:
APPENDIX I IC = 5: PERSONAL /DOMEST
Page 236 and 237:
APPENDIX I Table A4.1 continued Com
Page 238 and 239:
APPENDIX I IC = 7: LEATHER PROCESSI
Page 240 and 241:
APPENDIX I IC = 9: MINERAL OIL AND
Page 242 and 243:
APPENDIX I WASTE TREATMENT Table A5
Page 244 and 245:
APPENDIX I For the emission factors
Page 246 and 247:
APPENDIX I INDUSTRIAL USE Table A3.
Page 248 and 249:
APPENDIX I INDUSTRIAL USE Table A3.
Page 250 and 251:
APPENDIX I PRIVATE USE Table A4.5 C
Page 252 and 253:
APPENDIX I PRIVATE USE Table A3.16
Page 254 and 255:
APPENDIX I 246 B-tables Estimates f
Page 256 and 257:
APPENDIX I FORMULATION Table B2.2 f
Page 258 and 259:
APPENDIX I IC = 3: CHEMICAL INDUSTR
Page 260 and 261:
APPENDIX I IC = 5: PERSONAL/DOMESTI
Page 262 and 263:
APPENDIX I IC = 7: LEATHER PROCESSI
Page 264 and 265:
APPENDIX I IC = 9: MINERAL OIL AND
Page 266 and 267:
APPENDIX I IC = 11: POLYMERS INDUST
Page 268 and 269:
APPENDIX I IC =13: TEXTILE PROCESSI
Page 270 and 271:
APPENDIX I IC = 16: ENGINEERING IND
Page 272 and 273:
APPENDIX I Appendix I-a: List of sy
Page 274 and 275:
APPENDIX I No. Use Category No. Fun
Page 276 and 277:
Page 278 and 279:
Page 280 and 281:
APPENDIX I Appendix I-b: List of sy
Page 282 and 283:
APPENDIX I 290 Organic intermediate
Page 284 and 285:
APPENDIX I Other IC/UC combinations
Page 286 and 287:
APPENDIX II Appendix II Fate of che
Page 288 and 289:
APPENDIX II b) Inherent biodegradab
Page 290 and 291:
APPENDIX II log H % removal -4 -3 -
Page 292 and 293:
APPENDIX III Appendix III Evaluatio
Page 294 and 295:
APPENDIX III Field studies In gener
Page 296 and 297:
APPENDIX IV together the mentioned
Page 298 and 299:
290 Table 1 Selected soil test meth
Page 300 and 301:
292 Table 1 continued Selected soil
Page 302 and 303:
Page 304 and 305:
Page 306 and 307:
298 Table 1 Selected freshwater sed
Page 308 and 309:
APPENDIX VII Appendix VII Toxicity
Page 310 and 311:
APPENDIX VIII collection), and that
Page 312 and 313:
APPENDIX VIII chemicals (see Sectio
Page 314 and 315:
APPENDIX VIII Multimedia fate model
Page 316 and 317:
APPENDIX VIII Monitoring data Metal
Page 318 and 319:
APPENDIX VIII homeostatic regulatio
Page 320 and 321:
APPENDIX IX based on the proportion
Page 322 and 323:
APPENDIX IX Definition of “blocks
Page 324 and 325:
APPENDIX IX these “blocks” will
Page 326 and 327:
APPENDIX IX and PNECs for the “bl
Page 328 and 329:
APPENDIX XI Appendix XI Environment
Page 330 and 331:
APPENDIX XII Appendix XII Connectio
Page 332 and 333:
APPENDIX XII +40% compared to 1992.
Page 334 and 335:
APPENDIX XIII other substance is be
Page 336 and 337:
APPENDIX XIV Taxonomic group No. of
show all

technical guidance documents - Institute for Health and Consumer ...

You also want an ePaper? Increase the reach of your titles

Delete template?

Save as template?