Risk Assessment of Chemicals: An IntroductionC.J. van Leeuwen, J.L.M. Hermens Springer Science & Business Media, 1995 M10 31 - 374 pages In recent years many developments have taken place in promote co-operation between governments and other the field of risk assessment of chemicals. Many reports parties involved in chemical safety and to provide policy have been published by national authorities, industries guidance with emphasis on regional and subregional co and scientific researchers as well as by international bod operation. The Inter-Organization Programme for the ies such as the European Union, the Organization of Sound Management of Chemicals (IOMC) was estab Economic Cooperation and Development (OECD) and lished in 1995 and provides a mechanism for the six par the joint International Programme on Chemical Safety ticipating organizations (UNEP, ILO, FAO, UNIDO,WHO (IPCS) of the World Health Organization (WHO), the and OECD) to better co-ordinate policies and activities in International Labour Organization (lLO), and the United the field of chemical risk management. Nations Environment Programme (UNEP). The present book is an introduction to risk assessment of The development and international harmonization of risk chemicals. It contains basic background information on assessment methods is an important challenge. In sources, emissions, distribution and fate processes for Agenda 21 of the United Nations Conference on exposure estimation. It includes dose-effects estimation Environment and Development (UNCED), chapter 19 is for both human health related toxicology and ecotoxicol entirely devoted to the management of chemicals. For ogy as well as information on estimation methodologies. one of its recommendations, i. e. |
Contents
1 GENERAL INTRODUCTION | 1 |
121 Hazard identification step 1 | 3 |
123 Exposure assessment step 3 | 4 |
125 Risk classification step 5 | 5 |
126 Riskbenefit analysis step 6 | 6 |
127 Risk reduction step 7 | 7 |
128 Monitoring step 8 | 9 |
14 How risks are expressed | 10 |
54 Toxicity tests | 150 |
542 Acute single dose toxicity | 153 |
543 Repeated dose studies subacute and subchronic toxicity | 155 |
544 Chronic studies | 157 |
545 Carcinogenicity | 159 |
546 Genotoxicity testing | 161 |
547 Reproductive and developmental toxicity | 163 |
548 Other specific studies | 165 |
15 Perception of risks | 11 |
16 Uncertainties n risk management | 12 |
17 Model validation | 13 |
19 Contents of the book | 14 |
2 EMISSIONS OF CHEMICALS | 19 |
222 Desirable and undesirable substances | 20 |
23 Emissions and sources | 21 |
232 Types of emissions and sources | 23 |
234 Emissions in relation to risk assessment | 25 |
24 Data availability and generation | 26 |
242 Specific calculations | 27 |
243 The application of emission factors | 29 |
3 TRANSPORT ACCUMULATION AND TRANSFORMATION PROCESSES | 37 |
322 Equilibrium partitioning between phases | 38 |
323 Intramedia transport in air | 41 |
325 Intermedia transport | 44 |
33 Bioaccumulation | 50 |
332 Aquatic bioaccumulation processes | 51 |
333 Factors affecting bioconcentration | 57 |
334 Biomagnification | 61 |
335 Accumulation in terrestrial plants | 64 |
336 Accumulation in terrestrial invertebrates | 66 |
337 Accumulation in mammals and birds | 68 |
338 Methods for measuring terrestrial bioaecumulation | 69 |
342 Hydrolysis | 70 |
343 Oxidation | 71 |
344 Reduction | 73 |
345 Photochemical degradation | 74 |
346 Methods for measuring abiotic degradation | 76 |
352 Aerobic biodegradation and metabolic pathways | 77 |
353 Anaerobic biodegradation | 78 |
354 Reasons for the environmental persistence of chemicals | 79 |
355 Kinetics of biodegradation | 81 |
356 Assessing biodegradation and biodegradation rates | 82 |
Biotransformation | 84 |
364 Factors influencing enzyme activity | 90 |
365 Methods to measure biotransformation | 92 |
366 Biotransformation of some specific groups of compounds | 94 |
367 Enzyme inhibition and induction | 96 |
368 Effect of enzyme induction on toxicity | 97 |
4 EXPOSURE MODELLING | 101 |
414 Model types | 104 |
415 Models versus measurements | 105 |
416 Further reading | 106 |
423 Some examples of operational models | 107 |
424 Application of a local air model in the risk assessment of new and existing chemicals | 108 |
425 Input requirements for air models | 110 |
43 Water models | 111 |
433 Dispersion models | 112 |
434 Compartment models | 113 |
436 Data requirements for water models | 115 |
442 Fate processes in soil modelling | 116 |
443 Model types | 117 |
444 Use of soil models in the risk assessment of new and existing chemicals | 118 |
445 Data requirements for soil models | 119 |
45 Multimedia models | 120 |
453 Data requirements for multimedia models | 122 |
455 Available multimedia models and calculations | 123 |
456 Sample calculations | 124 |
46 Human exposure through the environment | 127 |
462 Choice of exposure scenario | 129 |
463 Direct exposure through the environment | 130 |
465 Derivation of the total daily uptake and sample calculations | 132 |
47 Consumer and occupational exposure | 134 |
472 Consumer exposure | 135 |
473 Occupational exposure | 138 |
5 TOXICITY TESTING AND HUMAN HEALTH | 145 |
53 Strategies in toxicity testing | 147 |
55 Safety evaluations for humans | 167 |
553 Mixtures of chemicals | 169 |
6 ECOTOXICOLOGICAL EFFECTS | 173 |
Differences between HRA and ERA | 174 |
623 Spatial scales | 175 |
624 Temporal scales | 176 |
625 Complexity of exposure | 177 |
63 Aquatic toxicity | 182 |
632 Shortterm toxicity | 184 |
633 Longterm toxicity | 189 |
634 Population dynamics | 194 |
635 Multispecies studies | 198 |
64 Sediment toxicity | 202 |
642 Exposure systems | 203 |
644 Sediment toxicity tests | 206 |
65 Terrestrial toxicity | 208 |
653 Tests with bacteria and plants | 211 |
655 Tests with birds and mammals | 213 |
656 Multispecies tests | 215 |
66 Factors modifying toxicity | 216 |
663 Biotic factors | 219 |
672 Mixture toxicity studies | 220 |
68 Derivation of PNECs | 221 |
681 Preliminary effects assessment | 222 |
682 Refined effects assessment | 223 |
683 Effects of secondary poisoning | 226 |
684 Comprehensive effects assessment | 229 |
7 PROPERTIES OF CHEMICALS AND ESTIMATION METHODOLOGIES | 237 |
723 Techniques | 241 |
73 Basic properties of estimation models | 242 |
731 Octanolwater partition coefficient | 243 |
732 Water solubility | 246 |
733 Vapour pressure | 249 |
734 Henrys law constant | 250 |
735 Acid dissociation constant | 252 |
74 Environmental fate nad estimation models | 254 |
742 Chemical degradation | 259 |
74 3 Biodegradation | 261 |
744 Soil sorption | 265 |
75 Effects and estimation models | 269 |
752 Human health effects | 276 |
76 Computer programs and databases | 279 |
8 PROCEDURES OF HAZARD AND RISK ASSESSMENT | 289 |
822 New substances | 290 |
823 Existing substances | 291 |
824 Plant protection products and biocides | 292 |
83 Elements of risk assessment | 293 |
832 Protection goals | 294 |
841 Data requirements | 295 |
843 Data quality and selection | 296 |
85 Exposure assessment | 297 |
852 Emissions | 300 |
854 Exposure and intake | 303 |
855 Occupational and consumer exposure | 305 |
856 Sample calculations | 306 |
86 Effects assessment | 310 |
863 Atmospheric risks | 314 |
864 Effects on human health | 315 |
865 Sample calculations | 319 |
87 Risk characterization | 320 |
873 Human health risks | 322 |
875 Sample calculations | 324 |
882 Environmental risk evaluation | 325 |
883 Human risk evaluation | 327 |
884 Risk reduction | 329 |
GLOSSARY | 335 |
INDEX | 359 |
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Common terms and phrases
acid acute toxicity adverse effects animals applied aquatic organisms Bilthoven bioaccumulation bioavailability bioconcentration biodegradation biological biomagnification biotransformation calculated carcinogenicity cells Chapter Chem chronic compartments compounds concentration contaminants Daphnia degradation derived developed distribution dose ecosystems ecotoxicity Ecotoxicology effects assessment emission endpoints environment enzyme Equation equilibrium estimated evaluation example experimental exposure assessment extrapolation factors fate Figure fish function genotoxicity growth guidelines hazard Henry's law human hydrophobic intake laboratory lipophilic log Kow measured ment methods mg/L models molecular molecule Netherlands NOAEL NOEC OECD organic chemicals oxidation parameters partition coefficient pesticides phase physicochemical plant PNEC pollutants population potential predicted processes properties QSAR quantitative rate constant reaction relationships risk assessment risk management Section sediment soil sorption species steady-state studies substances surface water Table terrestrial tion tissues toxicity data toxicity tests Toxicol Toxicology transport uncertainty uptake values water solubility xenobiotics