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PART 1
TOXICITY-TESTING NEEDS IN THE SELECT UNIVERSE
CONTENTS
1. INTRODUCTION
2. SAMPLE SELECTION
me Universe and the Sampling Frame
Pesticides and Inert Ingredients
of Pesticide Formulations
Cosmetic Ingredients
Drugs and Excipients in Drug Formulations
Food Additives
Chemicals in Commerce
Considerations in Developing the Sampling Strategy
Sampling Strategy
Sample Size
Sampling Plan
Screening the Sample for Minimal Toxicity Information
3. OPERATING POLICIES FOR IDENTIFICATION, ACQUISITION, AND
ORGANIZATION OF DATA
Restricted-Access or Confidential Information
Information on Toxicity in Humans
Chemical and Physical Characteristics,
Manufacturing Processes, Production Volumes,
Intended Uses, and Exposure of Humans
Chemical Review Articles
Articles in Foreign Languages
Substances Structurally Similar to Those in the
Sample
4. DATA EVALUATION
The Dossier Concept
General Principles for Evaluation of Toxicity-Testing
Protocols
Consideration of Exposure
Purity of Selected Substances
Guidelines for Assessing the Quality of Individual
Studies
Basic Criteria for Scientific Methods
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Selection of Reference Protocols
Reference Protocol Guidelines for Neuro-
behavioral-Toxicity Tests
Reference Protocol Guidelines for Genetic-
Taxicity Tests
Procedures for Evaluation of the Data Base
Initial Considerations
Adequacy Ratings
Measures of Adequacy for Tests Not Meeting the
Reference Protocol Guidelines
Dossier Review Process
Limitations of the Data Gathering Process
Interpretation of Data on Testing Quality
Characterizing the Sample and Options for Drawing
Inferences to the Select Universe
Construction of Tables for Analysis
Statistical Analysis of Data
Estimates Based on the Sample Alone
Estimates Based on the Subsample alone
Estimates Based on Both the Sample and the
Subsample
Machine-Readable Files
5. RESULTS
Quantity and Nature of Testing
Sample of 675 Substances
Subsample of 100 Substances
Quality of Testing
Testing Needs
Health-Hazard Assessment
Interpretation and Analysis of Physicochemical and
Exposure Data
6. SUMMARY AND CONCLUSIONS
REFERENCES
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Tables
1. Characteristics of Chemical Lists from Which
Sample Was Drawn
2. Six Codes of Chemical Classification in FDA Bureau
of Foods Dictionary Used to Form Food-Additives
Category from Which Food-Adaitive Sample Was Drawn
3. Required Studies in Screen of Sample of 675
Substances for Minimal Toxicity Information for
Subsample of 100
4. Sample Sizes for Sample and Subsample
5. Information Sought in Exhaustive Literature
Search for Each Substance in Subsample of 100
6. Committee Format for Recording Judgments about
Protocol of Toxicity Study
7. Estimated Percentages of Substances in
Seven Categories of Select Universe That Have
Five Basic Tests Used in Screen for
Prescribed Minimal Toxicity Information
8. Proportion of Substances Tested in Each Category
of Subsample According to Each of Defined
33 Test Types
9. Quality of Testing on 100 Substances in
Subsample, by Test Type
10. Distribution of 664 Quality Ratings of
Tests Done on 100 Substances in Subsample, by
Subsample Category
11. Comparison of Aggregate Quality Ratings (All G. A,
and IN) for Selected Acute Test Types and
Selected Chronic Test Types
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12. Quality of Testing of 3,350 Pesticides and Inert
Ingredients of Pesticide Formulations in
Select Universe
13. Quality of Testing of 3, 410 Cosmetic Ingredients
in Select Universe
14. Quality of Testing of 1, 815 Drugs and Excipients
in Drug Formulations in Select Universe
15. Quality of Testing of 8,627 Food Additives in
Select Universe
16. Quality of Testing of 12,860 Chemicals in Commerce
in Select Universe with Production Levels of
At Least 1 Million lb/yr
17. Quality of Testing of 13,911 Chemicals in Commerce
in Select Universe with Production Levels less
man 1 Million lb/yr
18. Quality of Testing of 21,752 Chemicals in Commerce
in Select Universe with Unknown or Inaccessible
Production Levels
19. Relative Comparison of Testing Need by Intended-Use
Category of Select Universe
20. Ability to Conduct Health-Hazard Assessment of
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Substances in Seven Categories of Select Universe 117
21. Availability of Specific Information on Substances
in Seven categories of Select Universe
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Figures
1. Process used to draw sample and subsample
from select universe
2. Steps in process of evaluating adequacy of
toxicity testing for substances
Outline of procedure for decision-making in
evaluating adequacy of toxicity information
on specific substance
4. Ability to conduct health-hazard assessment
of substances in seven categories of
select universe
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Appendix A Sample of 675 Substances and Subsample of 100
Substances from the "Select Universe" 129
Appendix B Testing for Various Situations of Chemical Use
and General Exposure to Direct and Indirect Food
Additives
Appendix C Testing for Various Situations of Chemical Use
and General Exposure to Oral or Parenteral Drugs
or Color Additives for Sutures
Appendix D Testing for Various Situations of Chemical Use
and General Exposure to Inhalation and
Veterinary Drugs
Appendix E Testing for Various Situations of Chemical Use
and General Exposure to Cosmetics and Dermal,
Vaginal-Rectal, Over-the-Counter, and
Ophthalmic Drugs
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Appendix F Testing for Various Situations of Chemical Use
and General Exposure to Pesticides 159
Appendix G Testing for Various Situations of Chemical Use
and General Exposure to Other Marketable
Chemicals 161
Appendix H Reference Protocols for Toxicity Testing 165
Appendix I Reference Protocol Guidelines for
Neurobehavioral-Ioxicity Tests 169
Appendix J Reference Protocol Guidelines for
Genetic-Ioxicity Tests 175
Appendix K Conceptual Issues Concerning the Interpretation
of Results of Studies of Reproductive and
Developmental Toxicity 177
Appendix L Major Components of a Dossier
Appendix M Procedures, Rationale, and Results of Data
Identification and Acquisition
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Representative terms from entire chapter:
reference protocol
