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REGULATORY TOXICOLOGY AND PHARMACOLOGY 12, 311-317 (1990)
Cumulative Subject Index 1
Volumes 1 1 - 1 2
A
Absorption coefficients literature-derived, for chemicals via oral and inhalation
exposure routes, 11, 237 Acceptable daily intake
food additives, effect of potential high intakes, toxico- logical evaluation, 11, 3
2-Acetylaminofluorene, see N-2-Fluorenylacetamide Administrators
science, relationship to public concern about chemical risk, editorial, 12, 1
Adults estimated soil ingestion, pilot study, 12, 88
Advisories fish consumption, evaluation, 12, 161 health, see Health advisories
Air containing trichloroethylene, health risk assessment, 11,
24 contaminants standard by OSHA, comparison with data
on chemical carcinogenesis, 12, 296 Announcements
Fifth Annual Meeting of the International Society of Regulatory Toxicology and Pharmacology, Inter- national Achievement Award, 11, 101
First International Conference on Food, Nutrition, and Chemical Toxicity, Guildford, Surrey, United Kingdom, April 1991, 12, 309
International Society of Regulatory Toxicology and Pharmacology Annual Meeting, Washington D.C., October 1990, 12, 105
Sixth Annual Meeting of the International Society of Regulatory Toxicology and Pharmacology, Wash- ington D.C., October 1990, 11, 100
Asbestos fibers human risk assessment, administrative perspective, 11,
63
B
Benzene sho~-termexposure limits, OSHA standard, analysis,
11,275
Benzo[a]pyrene evaluation as genetic procarcinogen, mechanistic con-
sidemtions, 12, 41 Bioassay
for prediction of developmental toxicity hazard potential of halogenated drinking water disinfection by- products, 11, 213
Blood, s ee a l so Plasma lead levels, relationship to soil lead from mining wastes,
assessment, 11, 158 Budget method
in calculation of potential high intakes of foodstuffs, use in determining acceptable daily intakes of food additives, 11, 3
G
Canada drug regulation, review, 12, 214
Cancer hazard, based scheme for carcinogen classification, 12,
270 lung, role of crystalline silica: review of recent experi-
mental evidence, 12, 224 risk, chlorine dioxide-disinfected water to hemodialysis
patients, review, 11, 42 Caramel
beverage use, acceptable daily intakes, effect of potential high intakes, toxicological evaluation, 11, 3
Carcinogenesis chemical, related data, comparison with OSHA air con-
taminants standard, 12, 296 potential of
food-packaging chemicals, evaluation with decision point approach, 12, 30
methidathion, evaluation (mouse), 12, 117 Carcinogens
classification scheme, 12, 270 food-related, regulation in Japan, 11, 149 human risk
assessment, administrative perspective, 11, 63 relevance of maximum tolerated dose, review, 11, 68
mechanistic considerations: genotoxic procarcinogens and nongenotoxic carcinogens, 12, 41
Boldface numbers indicate appropriate volume; lightface numbers indicate pagination.
311
0273-2300/90 $3.00 Copyright �9 1990 by Academic Press, Inc. All rights of reproduction in any form reserved.
312 CUMULATIVE SUBJECT INDEX
suspected, complex mixtures, hazard assessment: relative comparisons for improving regulatory consistency, 11, 132
variation in potency, quantitative factors, 12, 13 Chemicals
acute toxicity testing in nonlethal dose range: criteria based on clinical assessment of adverse effects, 12, 69
hazard assessment, associated uncertainties, compen- satory actions, 11, 123
Chlorine dioxide as water disinfectant, risk for hemodialysis patients, re-
view, 11, 42 Chloroacetic acid
developmental toxicity hazard potential, prediction by in vitro hydra assay, 11,213
2-Chlorophenol developmental toxicity hazard potential, prediction by
in vitro hydra assay, 11, 213 Cigarettes
classification as consumer message, analysis, 12, 253 tar yield, public perceptions, implications for regulation,
12, 64 Classification
carcinogens, scheme presentation, 12, 270 cigarettes as consumer message, analysis, 12, 253
Cleaning products household, skin irritation, comparative testing with Hill
Top chamber and gauze patch (human, rabbit), 12, 127
Consumer perception cigarette classification, analysis, 12, 253
Consumption, see also Food fiber, federal regulations on psyllium, editorial, 1 l, 1 fish, risk assessment and evaluation of advisories, 12,
161 Contaminants
air, OSHA standard, comparison with data on chemical carcinogenesis, 12, 296
Data base selection in toxicological risk assessment and manage-
ment, 11, 308 Developmental toxicity
hazard potential of halogenated drinking water disin- fection by-products, prediction by in vitro hydra assay, 11, 213
Dibromoacetonitrile developmental toxicity hazard potential, prediction by
in vitro hydra assay, 11,213 Dichloroacetone
developmental toxicity hazard potential, prediction by in vitro hydra assay, 11,213
1,2-Dichloroethane, see Ethylene dichloride
Diet, see also Food, Ingestion fiber intake and federal regulations on psyllium, edi-
torial, 11, 1 Dioxin
toxicity equivalence units, in expression of environ- mental limits of polychlorodibenzodioxins and polychlorodibenzofurans, 11, 8
Diseases non-life-threatening, treatment with antiviral drugs: re-
view of types of preclinical toxicity studies, 11, 81 Disinfection
drinking water, halogenated by-products, prediction of developmental toxicity hazard potential by in vitro
assay, 11,213 DNA
reactivity to food-packaging chemicals, evaluation with decision point approach, 12, 30
recombinant, lacZY marker, as tracking tool for ge- netically engineered microorganisms, small-scale field test, 11,253
Dosage nonlethal range, for acute chemical toxicity testing: cri-
teria based on clinical assessment of adverse effects, 12, 69
related drug toxicity, extrapolation from animals to hu- mans, review of different methods, 12, 107
Dose-response relationships biologically-based models, role in reduction of uncer-
tainty in health risk assessment, analysis, 11, 191 Drinking water
disinfection, halogenated by-products, prediction of de- velopmental toxicity hazard potential by in vitro assay, 11,213
formaldehyde in, comparative evaluation and approach to regulation, 11,220
Drugs, see also Pharmaceuticals antiviral, in treatment of non-life-threatening diseases:
review of types of preclinical toxicity studies, 11, 81
candidates, safety assessment importance of pharmacokinetic and receptor studies,
11,288 role of pharmacological profiling, 12, 238
dosage-related toxicity, extrapolation from animals to humans, review of different methods, 12, 107
regulation in Canada, review, 12, 214 regulatory standards: publication of 22nd revision of
United States Pharmacopeia and 17th edition of National Formulary, editorial, 11, 103
E
Environmental limits polychlorodibenzodioxins and polychlorodibenzofu-
rans, expression in TCDD toxicity equivalence units, 11, 8
Environmental Protection Agency hazard assessment of complex mixtures, relative com-
CUMULATIVE SUBJECT INDEX 313
parisons for improving regulatory consistency, 11, 132
health advisories lifetime, for hexahydro-l,3,5-trinitro-l,3,5-triazine,
comparison with water quality criteria, 11, 118 for 2,4,6-trinitrotoluene, comparison with water
quality criteria, 11, 114 Otfice of Drinking Water, and OSHA, comparison of
data base selection in toxicological risk assessment and management, 11,308
Ethylene dichloride human risk assessment, administrative perspective, 11,
63 Ethylene thiourea
evaluation as nongenotoxic carcinogen, mechanistic considerations, 12, 41
Exposure benzene, short-term limit, analysis of OSHA standards,
11,275 environmental
to 1,1,1-trichloroethane, health risk assessment, 11, 90
to trichloroethylene, health risk assessment, 11, 24 guidelines, community, derivation from no-observed-
adverse-effect levels, 11, 314 inhalation and oral, various chemicals, literature-derived
absorption eoeificients, 11,237 Exposure assessment
associated uncertainty in health risk assessment, 11, 191 polychlorodibenzodioxins and polychlorodibenzofu-
rans, environmental limits expressed in TCDD toxicity equivalence units, 11, 8
toluene diisocyanate, acceptable limits based on different airway effects (guinea pig, mouse), 12, 53
Extrapolations interspecies, see Interspecies extrapolations
F
Federal government executive branch, associated trends in centralized control
of regulatory policy, 11,262 Fiber
dietary intake, and federal regulations on psyllium, ed- itorial, 11, 1
Fish consumption, risk assessment and evaluation of advi-
sories, 12, 161 N-2-Fluorenylacetamide
evaluation as genetic procareinogen, mechanistic con- siderations, 12, 41
Food, see also Consumption and biotechnologies, safety and regulation, International
Food Biotechnology Council report, 12, 96 packaging materials, carcinogenic potential, evaluation
with decision point approach, 12, 30 produced by genetic modification, safety assurance, In-
ternational Food Biotechnology Council report
editorial, 12, 213, vii general legal and regulatory issues, 12, S159 introduction, 12, S1 methods of genetic modification and their use, 12,
$79 safety evaluation of
foods and food ingredients derived from micro- organisms, 12, S114
single chemical entities and simple chemically de- fined mixtures, 12, S129
whole foods and other complex mixtures, 12, S136 variability in composition of traditional foods: nu-
trients, microorganisms, and toxicants, 12, S11 related carcinogens, regulation in Japan, 11, 149 safety, relationship to public interest groups, 12, 263
Food additives acceptable daily intakes, effect of potential high intakes,
toxicological evaluation, 11, 3 indirect, migrating from packaging materials, safety as-
sessment procedures, workshop report, 12, 2 Food and Drug Administration
regulatory policy on dietary fiber, editorial, 11, 1 Formaldehyde
in drinking water:, comparative evaluation and approach to regulation, 11,220
13
Gastrointestinal tract bioavailability of lead from soil contaminated by mining
wastes, 11, 158 Genetic engineering
l a c Z Y marker as tracking tool for genetically engineered microorganisms, small-scale field test, 11,253
Genetic modification in food production, major issues regarding safety as-
surance, International Food Biotechnology Council report, 12, 96
foods produced by, safety assurance, International Food Biotechnology Council report
editorial, 12, 213, vii general legal and regulatory issues, 12, S159 introduction, 12, SI methods of genetic modification and their use, 12,
$79 safety evaluation of
foods and food ingredients derived from micro- organisms, 12, S114
single chemical entities and simple chemically de- fined mixtures, 12, S129
whole foods and other complex mixtures, 12, S 136 variability in composition of traditional foods: nu-
trients, microorganisms, and toxicants, 12, S11 Genotoxicity
mechanistic consideration in evaluation of chemical carcinogens, 12, 41
314 CUMULATIVE SUBJECT INDEX
I-t
Hazard assessment chemicals, associated uncertainties, compensatory ac-
tions, 11, 123 complex mixtures, relative comparisons for improving
regulatory consistency, 11, 132 formaldehyde in drinking water, comparative method,
use in regulation, 11,220 Health advisories
lifetime, for hexahydro-l,3,5-trinitro-t,3,5-triazine, recommended by EPA, comparison with water quality criteria, 11, 118
for 2,4,6-trinitrotoluene, recommended by EPA, com- parison with water quality criteria, 11, 114
Health authorities use of scientific data in human risk assessment of car-
cinogens, 11, 63 Health risk assessment
associated uncertainty, 11, 191 environmental exposure
1,1, l-trichloroethane, 11, 90 to triehloroethylene, 11, 24
Hemodialysis patients, risk of chlorine dioxide-disinfected water, re-
view, 11, 42 Hexahydro- 1,3,5-trinitro- 1,3,5-triazine
EPA lifetime health advisory and water quality criteria, comparison, 11, 118
I
Ingestion soil by adults, estimates, pilot study, 12, 88
International Food Biotechnology Council reports Biotechnologies and Food: A Summary of Major Issues
Regarding Safety Assurance, 12, 96 Biotechnology and Food: Assuring Safety of Foods Pro-
duced by Genetic Modification editorial, 12, 213, vii general legal and regulatory issues, 12, S159 introduction, 12, S1 methods of genetic modification and their use, 12,
$79 safety evaluation of
foods and food ingredients derived from micro- organisms, 12, S 114
single chemical entities and simple chemically de- fined mixtures, 12, S129
whole foods and other complex mixtures, 12, S 136 variability in composition of traditional foods: nu-
trients, microorganisms, and toxicants, 12, S11 Interspecies extrapolations
from animals to humans dose-related drug toxicity, review of different methods,
12, 107 respiratory effects of toluene diisocyanate, use in for-
mulation of acceptable exposure limits, 12, 53
role in uncertainty in health risk assessment, analysis, 11, 191
toxicologic: utility and futility of plasma levels of test substance, 12, 137
Japan regulatory policy on food-related carcinogens based on
risk assessment, 11, 149
L
Lead from mining wastes, content in soil, relationship to blood
lead, assessment, 11, 158 Legal principles
interaction with scientific principles, relationship to regulatory definitions of risk, 11, 201
Liver methidathion carcinogenicity, evaluation (mouse), 12,
117 Lung, see also Respiratory system
cancer, role of crystalline silica: review of recent exper- imental evidence, 12, 224
M
Maximum tolerated dose relevance to human carcinogenic risk, review, l l , 68
Methidathion carcinogenic potential, evaluation (mouse), 12, 117
Microorganisms genetically engineered, lacZY marker as environmental
tracking tool for, small-scale field test, l l , 253 Mining wastes
derived soil lead, relationship to blood lead, assessment, 11, 158
Models animal, variable airway effects of toluene diisocyanate,
basis for establishment of acceptable exposure limits (guinea pig, mouse), 12, 53
estimation of carcinogenic potency in quantitative risk assessment, 12, 13
for fish consumption advisories, based on risk assess- ments for contaminants, 12, 161
physiologically based pharmacokinetic dose-related drug toxicity, in extrapolation from an-
imals to humans, 12, 107 and dose-response models, role in reduction of un-
certainty in health risk assessment, analysis, 11, 191 plasma levels of test substance, evaluation for inter-
species extrapolations, 12, 137
N
National Formulary publication of 17th edition, editorial, 11, 103
CUMULATIVE SUBJECT INDEX 315
Nicotine -tar ratio, potential role in cigarette classification, anal-
ysis, 12, 253 Nitrilotriacetic acid
evaluation as nongenotoxic carcinogen, mechanistic considerations, 12, 41
O
Occupational Safety and Health Administration air contaminants standard, comparison with data on
chemical carcinogenesis, 12, 296 and EPA Office of Drinking Water, comparison of data
base selection in toxicological risk assessment and management, 11,308
standard for short-term exposure limit for benzene, analysis, 11, 275
OSHA, see Occupational Safety and Health Administra- tion
P
Packaging materials for food
carcinogenic potential, evaluation with decision point approach, 12, 30
migration of indirect food additives from, safety as- sessment procedures, workshop report, 12, 2
Pharmaceuticals, see also Drugs toxicity testing, international guideline harmonization,
12, 179 Pharmacokinetics
based studies, importance in drug safety evaluation, 11, 288
physiologically based models dose-related drug toxicity, in extrapolation from an-
imals to humans, 12, 107 and dose-response models, role in reduction of un-
certainty in health risk assessment, analysis, 11, 191 plasma levels of test substance, evaluation for inter-
species extrapolations, 12, 137 Pharmacology
based profiling of drug candidates, role in safety assess- ment, 12, 238
Plasma, see also Blood levels of test substance, evaluation for interspecies ex-
trapolations, 12, 137 Polychlorodibenzodioxin
environmental limits expressed in TCDD toxicity equivalence units, II , 8
Polychlorodibenzofuran environmental limits expressed in TCDD toxicity
equivalence units, l l , 8 Potency
carcinogenic, variation among chemicals, quantitative factors, 12, 13
Psyllium dietary use, federal regulations, editorial, 11, 1
Public interest groups relationship to food safety, 12, 263
Public opinion about chemical risk, relationship to science administra-
tors, editorial, 12, 1 Public perceptions
published cigarette tar yield, implications for regulation, 12, 64
Receptor studies importance in drug safety evaluation, 11,288
Regulatory definitions for risk: interaction of scientific and legal principles, 11,
201 Regulatory policy
Canadian, for drugs, analysis, 12, 214 consistency for hazard assessment of complex mixtures,
improvement by relative comparisons, 11, 132 federal, on dietary fiber, editorial, 11, 1 for formaldehyde in drinking water, approach based on
comparative hazard evaluation, 11,220 governmental trends toward centralization, 11,262 guidelines for pharmaceutical toxicity testing, harmo-
nization, 12, 179 Japanese, on food-related carcinogens, role of risk as-
sessment, 11, 149 for published cigarette tar yield, role of public perception
of data, 12, 64 threshold-based, for indirect food additives migrating
from food packaging materials, workshop report, 12, 2
Regulatory standards for drugs: publication of 22nd revision of United States
Pharmacopeia and 17th edition of National For- mulary, editorial, 11, 103
Respiratory system, see also Lung different effects of toluene diisocyanate in animals, as
basis for establishment of acceptable exposure lim- its, 12, 53
Risk chemical, public concern over, relationship to science
administrators, editorial, 12, 1 legal regulatory definitions: interaction of scientific and
legal principles, 11,201 Risk assessment
carcinogens, for humans administrative perspective, 11, 63 relevance of maximum tolerated dose, review, 11, 68
environmental introductions of genetically engineered microorganisms, efficacy of l a c Z Y marker system as tracking tool, small-scale field test, 11,253
fish consumption, 12, 161 health, see Health risk assessment and management, toxicological, associated data base
selection, 11, 308
316 CUMULATIVE SUBJECT INDEX
in regulation of food-related carcinogens in Japan, 11, 149
Risk management and assessment, toxicological, associated data base se-
lection, 11,308
Structure-activity relationships in evaluation of carcinogenic potential of food-packaging
chemicals, 12, 30
1"
Saccharin evaluation as nongenotoxic carcinogen, mechanistic
considerations, 12, 41 Safety assessment
drug candidates importance of pharmacokinetic and receptor studies,
11,288 role of pharmacological profiling, 12, 238
food-packaging chemicals, use of decision point ap- proach, 12, 30
indirect food additives from food packaging materials, workshop report, 12, 2
Safety assurance foods produced by genetic modification, International
Food Biotechnology Council report editorial, 12, 213, vii general legal and regulatory issues, 12, S159 introduction, 12, S1 methods of genetic modification and their use, 12,
$79 safety evaluation of
foods and food ingredients derived from micro- organisms, 12, S114
single chemical entities and simple chemically de- fined mixtures, 12, S129
whole foods and other complex mixtures, 12, S136 variability in composition of traditional foods: nu-
trients, microorganisms, and toxicants, 12, S11 major issues regarding biotechnology and food produc-
tion, International Food Biotechnology Council report, 12, 96
Safety factors approach to deriving community exposure guidelines
from no-observed-adverse-effect levels, 11,314 Scientific principles
interaction with legal principles, relationship to regu- latory definitions of risk, 11,201
Silica crystalline, role in lung cancer: review of recent exper-
imental evidence, 12, 224 Skin irritation
testing with Hill Top chamber and gauze patch, com- parison (human, rabbit), 12, 127
Soil adult ingestion estimates, pilot study, 12, 88 lead content from mining wastes, relationship to blood
lead, assessment, 11, 158
Tar cigarette yields, public perceptions of, implications for
regulation, 12, 64 -nicotine ratio, potential role in cigarette classification,
analysis, 12, 253 TCDD, see Dioxin Testing
Hill Top chamber and gauze patch, for skin irritation, comparison (human, rabbit), 12, 127
toxicity, see Toxicity testing 2,3,7,8-Tetrachlorodibenzo-p-dioxin, see Dioxin Toluene diisocyanate
acceptable exposure limits based on different airway ef- fects (guinea pig, mouse), 12, 53
Toxicity developmental, see Developmental toxicity drug dosage-related, extrapolation from animals to hu-
mans, review of different methods, 12, 107 interspecies extrapolations: utility and futility of plasma
levels of test substance, 12, 137 no-observed-adverse-effect levels, derived community
exposure guidelines, 1 l, 314 2,4,6-trinitrotoluene, related water quality criteria pro-
posal, l l , 104 Toxicity testing
acute, chemicals in nonlethal dose range: criteria based on clinical assessment of adverse effects, 12, 69
animal-based, limitations in drug safety evaluation, I I , 288
pharmaceuticals, international guideline harmonization, 12, 179
preclinical studies of antiviral drugs in treatment of non- life-threatening diseases, review, l l, 81
Toxicology evaluation of food additives: budget method, 11, 3
Trichloroacetic acid developmental toxicity hazard potential, prediction by
in vitro hydra assay, l l , 213 Trichloroacetonitrile
developmental toxicity hazard potential, prediction by in vitro hydra assay, 11, 213
1,1,1-Trichloroethane environmental exposure, health risk assessment, 1 l, 90
Trichloroethylene environmental exposure, health risk assessment, l l , 24
2,4,6-Trichlorophenol developmental toxicity hazard potential, prediction by
in vitro hydra assay, I l , 213
CUMULATIVE SUBJECT INDEX 317
2,4,6-Trinitrotoluene EPA health advisories and water quality criteria, com-
parison, II, t 14 water quality criteria proposal, 11, 104
Uncertainty in hazard assessment, compensatory actions, l l , 123 in health risk assessment, analysis, 11, 191
United States Pharmacopeia publication of 22nd revision, editorial, 11, 103
W
Water chlorine dioxide disinfection, risk for hemodialysis pa-
tients, review, 11, 42 drinking, s e e Drinking water quality criteria
for hexahydro-l,3,5-trinitro-l,3,5-triazine, compar- ison with EPA lifetime health advisory, 11, 118
for 2,4,6qrinitrotoluene comparisorz with EPA health advisories, l l, 114 proposal, 11, 104
Statement of Qwnership, management, and etr required by the Ac t o l October Z3. 1967, Section #369, T i t le 39, United geate~ Code: e l
REGULATORY TOXICOLOGY AND PHARMACOLOGY
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