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TOXICOLOGICAL REVIEW of HEXAVALENT CHROMIUM (CAS No DRAFT - DO NOT CITE OR QUOTE EPA/635/R -10/004 A www.epa.gov/iris TOXICOLOGICAL REVIEW OF HEXAVALENT CHROMIUM (CAS No. 18540-29-9) In Support of Summary Information on the Integrated Risk Information System (IRIS) September 2010 (Note: This document is a reassessment of the noncancer and cancer health effects associated with the oral route of exposure only.) 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 ii DRAFT - DO NOT CITE OR QUOTE CONTENTS—TOXICOLOGICAL REVIEW OF HEXAVALENT CHROMIUM (CAS No. 18540-29-9) LIST OF TABLES ......................................................................................................................... vi LIST OF FIGURES .........................................................................................................................x LIST OF ABBREVIATIONS AND ACRONYMS ...................................................................... xi FOREWORD ............................................................................................................................... xiii AUTHORS, CONTRIBUTORS, AND REVIEWERS ............................................................... xiv 1. INTRODUCTION ......................................................................................................................1 2. CHEMICAL AND PHYSICAL INFORMATION ....................................................................3 2.1. ENVIRONMENTAL SOURCES AND OCCURRENCE ................................................. 5 2.2. ENVIRONMENTAL CHEMISTRY, SPECIATION, AND BIOACCESSIBILITY ....... 7 2.3. ANALYTICAL METHODS ............................................................................................. 15 3. TOXICOKINETICS .................................................................................................................19 3.1. BIOACCESSIBILITY OF INGESTED HEXAVALENT CHROMIUM ....................... 19 3.1.1. In Vitro and Ex Vivo Studies of Bioaccessibility ............................................... 19 3.1.2. In Vivo Studies of Bioaccessibility ..................................................................... 24 3.2. BIOVAILABILITY, DISPOSITION, AND ELIMINATION OF INGESTED HEXAVALENT CHROMIUM ...................................................................................... 25 3.2.1. In Vitro and Ex Vivo Studies of Bioavailability, Disposition, and Elimination . 26 3.2.2. In Vivo Studies of Bioavailability, Disposition, and Elimination ....................... 27 3.2.2.1. Laboratory Animal Studies .......................................................................... 27 3.2.2.2. Human Studies ............................................................................................. 41 3.3. BIOCHEMISTRY OF INTRACELLULAR HEXAVALENT CHROMIUM ................ 46 3.4. TOXICOKINETIC CONSIDERATIONS FOR THE MODE OF ACTION OF INGESTED HEXAVALENT CHROMIUM ................................................................. 49 3.5. BIOLOGICALLY-BASED MODEL OF INGESTED CHROMIUM COMPOUNDS IN RATS AND HUMANS ............................................................................................. 52 3.6. CONSIDERATION OF CHROMIUM ESSENTIALITY VERSUS TOXICITY........... 66 4. HAZARD IDENTIFICATION .................................................................................................67 4.1. ORAL STUDIES IN HUMANS ...................................................................................... 67 4.1.1. Acute Exposure ................................................................................................... 67 4.1.2. Environmental Exposure ..................................................................................... 68 4.2. SUBCHRONIC AND CHRONIC STUDIES AND CANCER BIOASSAYS IN ANIMALS—ORAL ....................................................................................................... 80 4.2.1. Subchronic Oral Exposure ................................................................................... 81 4.2.2. Chronic Oral Exposure ...................................................................................... 101 4.3. REPRODUCTIVE AND DEVELOPMENTAL TOXICITY STUDIES—ORAL ....... 122 4.3.1. Effects on Reproductive Tissues and Mating Behavior .................................... 123 4.3.2. Effects on Reproductive Outcomes ................................................................... 134 4.3.3. Effects of Pregestational Exposure on Reproductive Outcome and Fetal Development ..................................................................................................... 139 4.3.4. Effects of Gestational and/or Lactational Exposure on Reproductive Outcome and Fetal Development ...................................................................... 142 4.4. SUMMARY OF HUMAN AND ANIMAL STUDIES BY ROUTES OF EXPOSURE OTHER THAN ORAL ............................................................................ 149 iii DRAFT - DO NOT CITE OR QUOTE 4.5. MECHANISTIC DATA AND OTHER STUDIES IN SUPPORT OF THE MODE OF ACTION ................................................................................................................. 150 4.5.1. Genotoxicity Studies ......................................................................................... 150 4.5.1.1. Genotoxicity Assays in Experimental Systems ......................................... 152 4.5.1.2. Genotoxicity Studies in Humans ............................................................... 178 4.5.2. Intracellular Reduction ...................................................................................... 183 4.6. SYNTHESIS OF MAJOR NONCANCER EFFECTS—ORAL ................................... 191 4.7. EVALUATION OF CARCINOGENICITY .................................................................. 199 4.7.1. Summary of Overall Weight of Evidence ......................................................... 199 4.7.2. Synthesis of Human, Animal, and Other Supporting Evidence ........................ 200 4.7.3. Mode-of-Action Information ............................................................................. 202 4.7.3.1. Hypothesized Mode of Action ................................................................... 202 4.7.3.2. Experimental Support for the Hypothesized Mode of Action ................... 203 4.7.3.3. Other Possible Modes of Action ................................................................ 211 4.7.3.4. Conclusions About the Hypothesized Mode of Action ............................. 212 4.7.3.5. Mutagenic Across All Routes of Exposure ............................................... 213 4.8. SUSCEPTIBLE POPULATIONS AND LIFE STAGES .............................................. 214 4.8.1. Possible Childhood Susceptibility ..................................................................... 214 4.8.2. Possible Gender Differences ............................................................................. 214 5. DOSE-RESPONSE ASSESSMENTS ....................................................................................215 5.1. ORAL REFERENCE DOSE (RfD) ............................................................................... 215 5.1.1. Choice of Principal Study and Critical Effect—with Rationale and Justification ....................................................................................................... 215 5.1.1.1. Subchronic Studies .................................................................................... 216 5.1.1.2. Chronic Studies .......................................................................................... 217 5.1.2. Methods of Analysis—Including Models (PBPK, BMD, etc.) ......................... 219 5.1.3. RfD Derivation—Including Application of Uncertainty Factors (UFs) ............ 222 5.1.4. Previous RfD Assessment ................................................................................. 222 5.2. UNCERTAINTIES IN THE ORAL REFERENCE DOSE ........................................... 223 5.3. ORAL CANCER ASSESSMENT ................................................................................. 224 5.3.1. Choice of Study/Data—with Rationale and Justification .................................. 224 5.3.2. Dose-Response Data .......................................................................................... 224 5.3.3. Dose Adjustments and Extrapolation Method(s) .............................................. 228 5.3.4. Oral Slope Factor ............................................................................................... 229 5.3.5. Application of ADAFs ...................................................................................... 229 5.3.6. Uncertainties in Cancer Risk Values
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