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OCR for page 179
Standing Operating Procedures for Developing Acute Exposure Guideline Levels for Hazardous Chemicals
Appendix D
Example of a Table of Contents of A Technical Support Document
TABLE OF CONTENTS
PREFACE
2
LIST OF TABLES
5
SUMMARY
6
1.
INTRODUCTION
9
2.
HUMAN TOXICITY DATA
10
2.1. Acute Lethality
10
2.2. Nonlethal Toxicity
10
2.2.1. Acute Studies
10
2.2.2. Epidemiologic Studies
11
2.3. Developmental/Reproductive Toxicity
11
2.4. Genotoxicity
11
2.5. Carcinogenicity
11
2.6. Summary
11
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Standing Operating Procedures for Developing Acute Exposure Guideline Levels for Hazardous Chemicals
3.
ANIMAL TOXICITY DATA
11
3.1. Acute Lethality
12
3.1.1. Nonhuman Primates
12
3.1.2. Dogs
12
3.1.3. Rats
12
3.1.4. Mice
13
3.1.5. Hamsters
14
3.2. Nonlethal Toxicity
14
3.2.1. Nonhuman Primates
14
3.2.2. Dogs
14
3.2.3. Rats
15
3.2.4. Mice
15
3.3. Developmental/Reproductive Toxicity
15
3.4. Genotoxicity
18
3.5. Carcinogenicity
19
3.6. Summary
19
4.
SPECIAL CONSIDERATIONS
20
4.1. Metabolism and Disposition
20
4.2. Mechanism of Toxicity
20
4.3. Structure-Activity Relationships
21
4.4. Other Relevant Information
21
4.4.1. Species Variability
21
4.4.2. Unique Physicochemical Properties
22
4.4.3. Concurrent Exposure Issues
22
5.
DATA ANALYSIS FOR AEGL-1
22
5.1. Summary of Human Data Relevant to AEGL-1
22
5.2. Summary of Animal Data Relevant to AEGL-1
22
5.3. Derivation of AEGL-1
22
6.
DATA ANALYSIS FOR AEGL-2
23
6.1. Summary of Human Data Relevant to AEGL-2
23
6.2. Summary of Animal Data Relevant to AEGL-2
23
6.3. Derivation of AEGL-2
23
7.
DATA ANALYSIS FOR AEGL-3
24
7.1. Summary of Human Data Relevant to AEGL-3
24
7.2. Summary of Animal Data Relevant to AEGL-3
24
7.3. Derivation of AEGL-3
24
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Standing Operating Procedures for Developing Acute Exposure Guideline Levels for Hazardous Chemicals
8.
SUMMARY OF AEGLS
25
8.1. AEGL Values and Toxicity Endpoints
25
8.2. Comparison with Other Standards and Criteria
26
8.3. Data Adequacy and Research Needs
27
9.
REFERENCES CITED
29
Appendix A
(Derivation of AEGL Values)
32
Appendix B
(Time Scaling Calculations for Dimethylhydrazine AEGLs)
36
Appendix C
(Carcinogenicity Assessment for Dimethylhydrazine)
39
Appendix D
(Derivation Summary for Dimethylhydrazine AEGLs)
41
Representative terms from entire chapter:
human data