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IRIS Toxicological Review of N-Butanol

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IRIS Toxicological Review of N-Butanol DRAFT - DO NOT CITE OR QUOTE EPA/635/R-11/081A www.epa.gov/iris TOXICOLOGICAL REVIEW OF n-BUTANOL (CAS No. 71-36-3) In Support of Summary Information on the Integrated Risk Information System (IRIS) September 2011 NOTICE This document is an External Review draft. This information is distributed solely for the purpose of pre-dissemination peer review under applicable information quality guidelines. It has not been formally disseminated by EPA. It does not represent and should not be construed to represent any Agency determination or policy. It is being circulated for review of its technical accuracy and science policy implications. U.S. Environmental Protection Agency Washington, DC DISCLAIMER This document is a preliminary draft for review purposes only. This information is distributed solely for the purpose of pre-dissemination peer review under applicable information quality guidelines. It has not been formally disseminated by EPA. It does not represent and should not be construed to represent any Agency determination or policy. Mention of trade names or commercial products does not constitute endorsement or recommendation for use. ii DRAFT - DO NOT CITE OR QUOTE CONTENTS - TOXICOLOGICAL REVIEW OF N-BUTANOL (CAS No. 71-36-3) LIST OF TABLES ...........................................................................................................................v LIST OF FIGURES ...................................................................................................................... vii LIST OF ABBREVIATIONS AND ACRONYMS .................................................................... viii FOREWORD ...................................................................................................................................x AUTHORS, CONTRIBUTORS, AND REVIEWERS ................................................................. xi 1. INTRODUCTION ......................................................................................................................1 2. CHEMICAL AND PHYSICAL INFORMATION ....................................................................3 3. TOXICOKINETICS ...................................................................................................................5 3.1. ABSORPTION .................................................................................................................... 5 3.1.1. Oral Absorption ............................................................................................................. 5 3.1.2. Respiratory Tract Absorption ........................................................................................ 5 3.1.3. Dermal Absorption ........................................................................................................ 6 3.2. DISTRIBUTION ................................................................................................................. 7 3.3. METABOLISM ................................................................................................................... 8 3.4. ELIMINATION ................................................................................................................. 11 3.5. PHYSIOLOGICALLY BASED PHARMACOKINETIC MODELS ............................... 11 4. HAZARD IDENTIFICATION .................................................................................................17 4.1. STUDIES IN HUMANS ................................................................................................... 17 4.1.1. Oral Exposure .............................................................................................................. 17 4.1.2. Inhalation Exposure ..................................................................................................... 17 4.2. SUBCHRONIC AND CHRONIC STUDIES AND CANCER BIOASSAYS IN ANIMALS—ORAL AND INHALATION ...................................................................... 24 4.2.1. Oral .............................................................................................................................. 24 4.2.2. Inhalation ..................................................................................................................... 26 4.3. REPRODUCTIVE/DEVELOPMENTAL STUDIES—ORAL AND INHALATION ..... 30 4.3.1. Oral Studies ................................................................................................................. 30 4.3.2. Inhalation Studies ........................................................................................................ 35 4.4. OTHER DURATION- OR ENDPOINT-SPECIFIC STUDIES ....................................... 39 4.5. MECHANISTIC DATA AND OTHER STUDIES .......................................................... 39 4.5.1. Genotoxicity Studies ................................................................................................... 39 4.5.2. Studies Evaluating Effects on the Nervous System, Liver, and Other Organs ........... 40 4.6. SYNTHESIS OF MAJOR NONCANCER EFFECTS ..................................................... 40 4.6.1. Oral .............................................................................................................................. 40 4.6.2. Inhalation ..................................................................................................................... 43 4.6.3. Mode-of-Action Information for Noncancer ............................................................... 46 4.7. EVALUATION OF CARCINOGENICITY ..................................................................... 47 4.7.1. Summary of Overall Weight of Evidence ................................................................... 47 4.8. SUSCEPTIBLE POPULATIONS AND LIFE STAGES .................................................. 47 4.8.1. Possible Childhood Susceptibility ............................................................................... 47 4.8.2. Possible Gender Differences ....................................................................................... 48 5. DOSE-RESPONSE ASSESSMENTS ......................................................................................49 iii DRAFT - DO NOT CITE OR QUOTE 5.1. ORAL REFERENCE DOSE (RfD) .................................................................................. 49 5.1.1. Choice of Principal Study and Critical Effect—Rationale and Justification .............. 49 5.1.2. Methods of Analysis—Including Models (e.g., PBPK, BMD) ................................... 53 5.1.3. RfD Derivation—Including Application of Uncertainty Factors (UFs) ..................... 56 5.1.4. Previous RfD Assessment ........................................................................................... 57 5.2. INHALATION REFERENCE CONCENTRATION (RfC) ............................................. 57 5.2.1. Choice of Principal Study and Critical Effect—Rationale and Justification .............. 57 5.2.2. Methods of Analysis—Including Models (e.g., PBPK, BMD) ................................... 60 5.2.3. RfC Derivation—Including Application of Uncertainty Factors (UFs) ...................... 62 5.2.4. Previous RfC Assessment ........................................................................................... 63 5.3. UNCERTAINTIES IN THE RfD AND RfC .................................................................... 63 5.4. CANCER ASSESSMENT ................................................................................................ 65 6. MAJOR CONCLUSIONS IN THE CHARACTERIZATION OF HAZARD AND DOSE RESPONSE ...............................................................................................................................67 6.1. HUMAN HAZARD POTENTIAL ................................................................................... 67 6.2. DOSE RESPONSE ............................................................................................................ 68 6.2.1. Oral Noncancer ........................................................................................................... 68 6.2.2. Inhalation Noncancer .................................................................................................. 69 6.2.3. Cancer—Oral and Inhalation ...................................................................................... 70 7. REFERENCES .........................................................................................................................71 APPENDIX A. SUMMARY OF EXTERNAL PEER REVIEW AND PUBLIC COMMENTS AND DISPOSITION ............................................................................................................. A-1 APPENDIX B. BENCHMARK DOSE CALCULATIONS FOR NONCANCER QUANTIFICATION ...............................................................................................................B-1 APPENDIX C. SUPPLEMENTAL INFORMATION ...............................................................C-1 APPENDIX D. n-BUTANOL PBPK MODEL ......................................................................... D-1 iv DRAFT - DO NOT CITE OR QUOTE LIST OF TABLES Table 2-1. Physical and chemical properties of n-butanol ............................................................. 3 Table 3-1. n-Butanol metabolism by hepatic or pulmonary ADH in male rats ........................... 10 Table 3-2. Physiological parameters for a PBPK model for the n-butyl series in the rat and human ..................................................................................................................................... 14 Table 3-3. Metabolic
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