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

More documents

Recommendations

Info

EFFECTS ASSESSMENT Further details on the evaluation of the adequacy of data are to be found in Appendix III. Special guidance for metals and metal compounds, petroleum substances and ionisable substances is given in Appendix VIII, IX and XI, respectively. 3.2.2 Quantitative Structure-Activity Relationships Reliable QSAR estimates for fish, Daphnia and algal toxicity are available for chemicals with a non-specific mode of action. These estimates can be used to assist in data evaluation and/or to contribute to the process of deciding whether further testing is necessary to clarify an endpoint of concern and if so, to optimise the testing strategy, where appropriate. Chapter 4 (Use of QSARs) gives full details on the use of QSAR estimates within the testing strategy for: • predicting the toxicity of chemicals with a non-specific mode of action; and • predicting long-term fish toxicity. Table 15 Overview of toxicity test endpoints Short-term studies: − If a test report does not indicate the L(E)C50 values but the raw data are presented, the L(E)C50 should be calculated, for example by Probit analysis. If only one toxicity value lies between the L(E)C0 and the L(E)C100, the L(E)C50 cannot be calculated by Probit analysis. Instead, the L(E)C50 may be estimated by, e.g., linear regression. − If results are presented as >L(E)C10 and
EFFECTS ASSESSMENT 3.3 EFFECTS ASSESSMENT FOR THE AQUATIC COMPARTMENT 3.3.1 Calculation of PNEC For the aquatic environment, a PNEC is derived that, if not exceeded, ensures an overall protection of the environment. Certain assumptions are made concerning the aquatic environment which allow, however uncertain, an extrapolation to be made from single-species short-term toxicity data to ecosystem effects. It is assumed that: • ecosystem sensitivity depends on the most sensitive species, and; • protecting ecosystem structure protects community function. These two assumptions have important consequences. By establishing which species is the most sensitive to the toxic effects of a chemical in the laboratory, extrapolation can subsequently be based on the data from that species. Furthermore, the functioning of any ecosystem in which that species exists is protected provided the structure is not sufficiently distorted as to cause an imbalance. It is generally accepted that protection of the most sensitive species should protect structure, and hence function. For most substances, the pool of data from which to predict ecosystem effects is very limited as, in general, only short-term toxicity data are available. In these circumstances, it is recognised that, while not having a strong scientific validity, empirically derived assessment factors must be used. Assessment factors have also been proposed by the US EPA and OECD (1992d). In applying such factors, the intention is to predict a concentration below which an unacceptable effect will most likely not occur. It is not intended to be a level below which the chemical is considered to be safe. However, again, it is likely that an unacceptable effect will not occur. In establishing the size of these assessment factors, a number of uncertainties must be addressed to extrapolate from single-species laboratory data to a multi-species ecosystem. These areas have been adequately discussed in other papers, and may best be summarised under the following headings: • intra- and inter-laboratory variation of toxicity data; • intra- and inter-species variations (biological variance); • short-term to long-term toxicity extrapolation; • laboratory data to field impact extrapolation (additive, synergistic and antagonistic effects from the presence of other substances may also play a role here). The size of the assessment factor depends on the confidence with which a PNECwater can be derived from the available data. This confidence increases if data are available on the toxicity to organisms at a number of trophic levels, taxonomic groups and with lifestyles representing various feeding strategies. Thus lower assessment factors can be used with larger and more relevant datasets than the base-set data. Calculation of a PNEC using assessment factors is described in Section 3.3.1.1. If a large data set from long-term tests for different taxonomic groups is available statistical extrapolation methods may be used to derive a PNEC (Section 3.3.1.2.). In general, it is assumed that sufficient test data for use of statistical extrapolation methods will only be available for relatively few substances and that these data will be primarily fresh water and terrestrial toxicity data. Therefore, the use of statistical extrapolation methods is only described for these two 99
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 39 and 40:
ENVIRONMENTAL EXPOSURE ASSESSMENT T
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 and 60: 2.3.6.3 Photochemical reactions in
Page 61 and 62: constant of zero. However, if it ca
Page 63 and 64: ENVIRONMENTAL EXPOSURE ASSESSMENT A
Page 65 and 66: ENVIRONMENTAL EXPOSURE ASSESSMENT T
Page 67 and 68: ENVIRONMENTAL EXPOSURE ASSESSMENT a
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
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 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: EFFECTS ASSESSMENT • it is clearl
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 ...

Create successful ePaper yourself

Delete template?

Save as template?