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Table 21.1 Some Agencies and Statutes Involved in Regulation of Toxic Chemicals in the United States Food and Drug Administration (FDA) Food, Drug, and Cosmetic Act Labor Department Occupational Safety and Health Act Consumer Product Safety Commission Consumer Product Safety Act Environmental Protection Agency (EPA) Federal Insecticide, Fungicide, and Rodenticide Act Clean Air Act Federal Water Pollution Control Act Safe Drinking Water Act Toxic Substances Control Act Resource Conservation and Recovery Act State governments Various state and local laws Enforcement of certain aspects of federal law delegated to states
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Although the objective of much, but by no means all, toxicity testing is the elimination of potential risks to humans, most of the testing is carried out on experimental animals. This is necessary because our current knowledge of quantitative structure activity relationships (QSAR) does not permit accurate extrapolation to new compounds. Human data are dif cult to obtain experimentally for ethical reasons but necessary for such deleterious effects as irritation, nausea, allergies, odor evaluation, and some higher nervous system functions. Some insight may be obtained in certain cases from occupational exposure data, although this often tends to be irregular in time and not clearly de ned as to the composition of the toxicant or the exposure levels, because multiple exposure is common. Clearly, any experiments involving humans must be carried out under carefully de ned conditions after other testing is complete. Although for a variety of reasons extrapolation from experimental animals to humans presents problems, including differences in metabolic pathways, dermal penetration, mode of action, and others, experimental animals present numerous advantages in testing procedures. These advantages include the possibility of clearly de ned genetic constitution and their amenity to controlled exposure, controlled duration of exposure, and the possibility of detailed examination of all tissues following necropsy. Although not all tests are required for all potentially toxic chemicals, any of the tests shown in Table 21.2 may be required by the regulations imposed under a particular law. The particular set of tests required depends on the predicted or actual use of the chemical, the predicted or actual route of exposure, and the chemical and physical properties of the chemical.
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Table 21.2 Summary of Toxicity Tests and Related End Points I Chemical and physical properties For the chemical in question, probable contaminants from synthesis as well as intermediates and waste products from the synthetic process II Exposure and environmental fate A. Degradation studies hydrolysis, photodegradation, etc. B. Degradation in soil, water, under various conditions C. Mobility and dissipation in soil, water, and air D. Accumulation in plants, aquatic animals, wild terrestrial animals, food plants, and animals, etc. III In vivo tests A. Acute 1. LD50 and LC50 oral, dermal or inhaled 2. Eye irritation 3. Dermal irritation 4. Dermal sensitization B. Subchronic 1. 30- to 90-day feeding 2. 30- to 90-day dermal or inhalation exposure C. Chronic/reproduction 1. Chronic feeding (including oncogenicity tests) 2. Teratogenicity 3. Reproduction (multi-generation) D. Special tests 1. Neurotoxicity 2. Potentiation 3. Metabolism 4. Pharmacodynamics 5. Behavior IV In vitro tests A. Mutagenicity prokaryote (Ames test) B. Mutagenicity eukaryote (Drosophila, mouse, etc.) C. Chromosome aberration (Drosophila, sister chromatid exchange, etc.) V Effects on wildlife Selected species of wild mammals, birds, sh, and invertebrates: acute toxicity, accumulation, and reproduction in laboratory-simulated eld conditions
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21.2 21.2.1
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Regardless of the chemical tested and whether the test is for acute or chronic toxicity, all in vivo testing requires the reproducible administration of a known dose of the chemical under test, applied in a reproducible manner, that is generally related to the expected route of humans exposure. The nature and degree of the toxic effect can be
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