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Systematic Review Protocol for the Inorganic Mercury Salts IRIS Assessment

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Systematic Review Protocol for the Inorganic Mercury Salts IRIS Assessment EPA/635/R-20/239 IRIS Assessment Protocol www.epa.gov/iris Systematic Review Protocol for the Inorganic Mercury Salts IRIS Assessment CASRN 7487-94-7 (Mercuric Chloride) CASRN 1344-48-5 (Mercuric Sulfide) CASRN 10112-91-1 (Mercurous Chloride) February 2021 Integrated Risk Information System Center for Public Health and Environmental Assessment Office of Research and Development U.S. Environmental Protection Agency Washington, DC Systematic Review Protocol for the Inorganic Mercury Salts IRIS Assessment DISCLAIMER This document is a preliminary draft for review purposes only. This information is distributed solely for review purposes under applicable information quality guidelines. It has not been formally disseminated by the Environmental Protection Agency. It does not represent and should not be construed to represent any Agency determination or policy. It is being circulated for comments on its technical clarity and science policy implications. Mention of trade names or commercial products does not constitute endorsement or recommendation for use. This document is a draft for review purposes only and does not constitute Agency policy. ii DRAFT―DO NOT CITE OR QUOTE Systematic Review Protocol for the Inorganic Mercury Salts IRIS Assessment CONTENTS AUTHORS|CONTRIBUTORS|REVIEWERS ........................................................................................................ 1. INTRODUCTION ...................................................................................................................................... 1 1.1. BACKGROUND INFORMATION ON INORGANIC MERCURY SALTS ................................................ 2 1.1.1. Physical and Chemical Properties ....................................................................................... 2 1.1.2. Sources, Production, and Use ............................................................................................. 3 1.1.3. Environmental Fate and Transport ..................................................................................... 4 1.1.4. Environmental Concentrations ........................................................................................... 4 1.1.5. Potential for Human Exposure ............................................................................................ 5 1.1.6. Populations and Lifestages with Potentially Greater Exposures ........................................ 5 1.1.7. Previous Assessments of Inorganic Mercury Salts by the Environmental Protection Agency (EPA) and Other Health Agencies ......................................................... 5 1.2. SCOPING AND PROBLEM FORMULATION SUMMARY ................................................................ 10 1.2.1. SCOPING SUMMARY ......................................................................................................... 10 1.2.2. PROBLEM FORMULATION ................................................................................................. 10 2. OVERALL OBJECTIVES, SPECIFIC AIMS, AND POPULATIONS, EXPOSURES, COMPARATORS, AND OUTCOMES (PECO) CRITERIA ....................................................................................................... 12 2.1. SPECIFIC AIMS ............................................................................................................................. 12 2.2. POPULATIONS, EXPOSURES, COMPARATORS, AND OUTCOMES (PECO) CRITERIA .................... 14 3. LITERATURE SEARCH AND SCREENING STRATEGIES ............................................................................ 17 3.1. LITERATURE SEARCH STRATEGIES .............................................................................................. 18 3.1.1. Database Search Term Development ............................................................................... 18 3.1.2. Database Searches ............................................................................................................ 18 3.1.3. Other Sources Consulted .................................................................................................. 19 3.1.4. Non-Peer-Reviewed Data ................................................................................................. 21 3.2. SCREENING PROCESS .................................................................................................................. 22 3.2.1. Application of PECO Criteria ............................................................................................. 22 3.2.2. Literature Flow Diagrams .................................................................................................. 23 4. LITERATURE INVENTORY AND REFINED EVALUATION PLAN ................................................................ 31 4.1. LITERATURE INVENTORY PROCESS ............................................................................................. 31 4.2. PRELIMINARY LITERATURE INVENTORY RESULTS ....................................................................... 32 This document is a draft for review purposes only and does not constitute Agency policy. iii DRAFT―DO NOT CITE OR QUOTE Systematic Review Protocol for the Inorganic Mercury Salts IRIS Assessment 5. REFINED EVALUATION PLAN ................................................................................................................ 43 6. KEY SCIENCE ISSUES .............................................................................................................................. 46 7. STUDY EVALUATION (REPORTING, RISK OF BIAS, AND SENSITIVITY) STRATEGY ................................. 47 7.1. STUDY EVALUATION OVERVIEW FOR HEALTH EFFECT STUDIES ................................................ 47 7.2. EXPERIMENTAL ANIMAL STUDY EVALUATION ........................................................................... 51 7.3. MECHANISTIC STUDY EVALUATION ............................................................................................ 60 8. ORGANIZING THE HAZARD REVIEW ..................................................................................................... 61 8.1. EPIDEMIOLOGY STUDY EVALUATION ......................................................................................... 63 9. DATA EXTRACTION OF STUDY METHODS AND RESULTS ...................................................................... 71 9.1. STANDARDIZING REPORTING OF EFFECT SIZES .......................................................................... 72 9.2. STANDARDIZING ADMINISTERED DOSE LEVELS/CONCENTRATIONS ......................................... 73 10. SYNTHESIS OF EVIDENCE ...................................................................................................................... 74 10.1. SYNTHESES OF HUMAN AND ANIMAL HEALTH EFFECTS EVIDENCE ........................................... 78 10.2. MECHANISTIC INFORMATION .................................................................................................... 79 10.2.1. Toxicokinetic/ADME Information and Pharmacokinetic (PK)/Physiologically Based Pharmacokinetic (PBPK) Models ............................................................................ 79 10.2.2. Strategies To Identify Analogues To Inform Read-Across for Mercurous Chloride .......... 81 11. EVIDENCE INTEGRATION ...................................................................................................................... 82 11.1. INTEGRATION WITHIN THE HUMAN AND ANIMAL EVIDENCE ................................................... 86 11.2. OVERALL EVIDENCE INTEGRATION JUDGMENTS ....................................................................... 96 11.3. HAZARD CONSIDERATIONS FOR DOSE-RESPONSE ................................................................... 103 12. DOSE-RESPONSE ASSESSMENT: SELECTING STUDIES AND QUANTITATIVE ANALYSIS ....................... 105 12.1. SELECTING STUDIES FOR DOSE-RESPONSE ASSESSMENT ........................................................ 106 12.2. CONDUCTING DOSE-RESPONSE ASSESSMENT ......................................................................... 110 12.2.1. Dose-Response Analysis in the Range of Observation ................................................... 111 12.2.2. Extrapolation: Oral Slope Factor ..................................................................................... 113 12.2.3. Extrapolation: Reference Values..................................................................................... 114 13. PROTOCOL HISTORY ........................................................................................................................... 116 REFERENCES ............................................................................................................................................... R-1 APPENDIX A. SEARCH AND SCREENING STRATEGIES ................................................................................ A-1 APPENDIX B. PROCESS FOR SEARCHING AND COLLECTING EVIDENCE FROM SELECTED OTHER RESOURCES .......................................................................................................................................... B-1 This document is a draft for review purposes only and does not constitute Agency policy. iv DRAFT―DO NOT CITE OR QUOTE Systematic Review Protocol for the Inorganic Mercury Salts IRIS Assessment B.1. REVIEW OF REFERENCE LISTS FROM EXISTING ASSESSMENTS (FINAL OR PUBLICLY AVAILABLE DRAFT), JOURNAL REVIEW ARTICLES, AND STUDIES CONSIDERED RELEVANT TO PECO BASED ON FULL-TEXT SCREENING ............................................................ B-1 B.2. EPA COMPTOX
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