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OCR for page 199
PART 2
SETTING PRIORITIES FOR TOXICITY TESTING
CONTENTS
1. INTRODUCTION
DESIGN OF THE PRIORITY-SETTING SYSTEM
Goal of Priority-Setting
Chemicals Considered
Structure of the System
Analysis of Information
Estimating Exposure
Estimating Toxic Effects
Assessment and Decision-Making
Design Factors
Describing the Priority-Setting System
Accuracy of Stages or Tests
Measuring Performance
Cost
3. BRIEFLY FOLLOWING A CHEMICAL THROUGH AN
ILLUSTRATIVE SYSTEM
Stage 1
Stage 2
Stage 3
Stage 4
4. DETAILED DESCRIPTION OF THE OPERATION OF AN
ILLUSTRATIVE SYSTEM
Introduction
Elements of Design
Goal
Universe
Assessment
Structure
Rules for Selection
Design Parameters
Stage 1
Exposure Data Elements
Toxicity Data Elements
Selection Rules
Stage 2
Exposure Data Elements
Toxicity Data Elements
Selection Rules
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OCR for page 200
Stage 3
Exposure Data Elements
Toxicity Data Elements
Selection Rules
Stage 4
5. FUTURE DEVELOPMENT, IMPLEMENTATION, AND REFINE
MENT OF THE SYSTEM
Development
Implementation
Further Refinement
Evaluation
Possible New Data ELements
The Use of Surveys and Epidemiologic
Information
Developing Very-Low-Cost (VLC) Tests
Random Sampling
6. CONCLUSIONS AND RECOMMENDATIONS
REFERENCES
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lo_
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OCR for page 201
Tables
Target Organs and Chemically Induced Effects in
Humans
2.
Possible Results of Test Having Three Results:
High, Medium, and Low
Illustrative Stage 1 Estimates of Probability of
Exposure in Relation to Use and Production
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220
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4. Illustrative Estimates of Distribution of
Production Volumes in Relation to Use Categories 242
Chemical Groups Associated with Human Health
Effects~Either Directly or After Metabolic
Activation
6. Significance of Ranking of RTECS Codes for Car-
cinogenic Potential
7. Estimated Proportions of Chemicals with Given
Carcinogenic Potency, by RTECS Code
8. Estimated Proportions of Chemicals with RTECS
Codes Related to Cancer
9. Selected Sources of Exposure Information by
Use Class
10. Data Needs for Use Classes
11. Hypothetical Estimates of Probability Distributions
of Degree of Exposure Generated in Stage 2 in Relation
to Estimated Degrees of Concern and Confidence
12. Hypothetical Percentages of Chemicals as Estimated
by Assessor to Have Given Degrees of Concern and
Confidence in Estimate
13. Selected Sources of Toxicity Information by
Effect
14. Hypothetical Estimates of Probability Distributions
of Carcinogenic Potency as Generated in Stage 2, in
Relation to Assigned Degree of Concern about Carcino-
genicity and.Degree of Confidence in Assignment
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OCR for page 202
15. Hypothetical Estimates of Probability Distributions
of Degree of Exposure Generated in Stage 3, in Re-
lation to Assigned Degree of Confidence in Assignment 272
16. Hypothetical Estimates of Probability Distributions
of Carcinogenic Potency as Generated in Stage 3, in
Relation to Assigned Degree of Concern about Carcino-
genicity and Degree of Confidence in Assignment
274
17. Estimates of Costs of Some Carcinogenicity Tests 276
18. Correlation among Results of Salmonella/microsome
Tests Performed by 12 Investigators
19. Predictive Accuracy of Various Short-Term Tests
for Carcinogenicity
20. Predictive Accuracy of Several Short-Term Tier
Testing Regimens
21. Chemicals Analyzed by Short-Term Tests (International
Collaborative Study)
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OCR for page 203
Figures
Page
le Example of one stage or building block in process
of investigation and control of toxic substances. 211
Illustration of misclassification
3. Stage 1 of illustrative system.
4. Stage 2 of illustrative system.
5. Stages 3 and 4 of illustrative system.
Be Decision rules used in processing example
chemical bispbenol A.
7.
Sample checklist for Stage 2 exposure assessment,
to be filled out by assessor reviewing dossier.
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Age
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OCR for page 204
Page
Appendix A Review of Selected Priority-Setting Systems 301
Appendix B Mathematical Modeling of the Priority
Setting Process and Resulting Decision Rules 319
Appendix C Expert Judgment and the Treatment of
Uncertainty 347
Appendix D The Analysis of Structure-Activity Relation
ships in Selecting Potentially Toxic
Compounds for Testing 355
Appendix E Costs of Misclassification 363
Appendix F Differences Between Part 1 and Part 2 381
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Representative terms from entire chapter:
probability distributions
