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Toxicological Review of Tert-Butyl Alcohol (Tert-Butanol)

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Toxicological Review of Tert-Butyl Alcohol (Tert-Butanol) EPA/635/R-20/370Fa www.epa.gov/iris Toxicological Review of tert-Butyl Alcohol (tert-Butanol) [CASRN 75-65-0] August 2021 Integrated Risk Information System Center for Public Health and Environmental Assessment Office of Research and Development U.S. Environmental Protection Agency Washington, DC Toxicological Review of tert-Butyl Alcohol (tert-Butanol) DISCLAIMER This document has been reviewed in accordance with U.S. Environmental Protection Agency policy and approved for publication. Mention of trade names or commercial products does not constitute endorsement or recommendation for use. ii Toxicological Review of tert-Butyl Alcohol (tert-Butanol) CONTENTS AUTHORS | CONTRIBUTORS | REVIEWERS ................................................................................................... x PREFACE ...................................................................................................................................................... xiv PREAMBLE TO IRIS TOXICOLOGICAL REVIEWS.......................................................................................... xviii EXECUTIVE SUMMARY .............................................................................................................................. xxvi LITERATURE SEARCH STRATEGY | STUDY SELECTION AND EVALUATION ............................................... xxxii 1. HAZARD IDENTIFICATION .................................................................................................................... 1-1 1.1. OVERVIEW OF CHEMICAL PROPERTIES AND TOXICOKINETICS ..................................................... 1-1 1.1.1. Chemical Properties .......................................................................................................... 1-1 1.1.2. Toxicokinetics .................................................................................................................... 1-1 1.1.3. Description of Toxicokinetic Models ................................................................................. 1-3 1.1.4. Chemicals Extensively Metabolized to tert-Butanol ......................................................... 1-4 1.2. PRESENTATION AND SYNTHESIS OF EVIDENCE BY ORGAN/SYSTEM ............................................ 1-4 1.2.1. Kidney Effects .................................................................................................................... 1-4 1.2.2. Thyroid Effects ................................................................................................................. 1-45 1.2.3. Developmental Effects .................................................................................................... 1-54 1.2.4. Neurodevelopmental Effects........................................................................................... 1-62 1.2.5. Reproductive Effects ....................................................................................................... 1-66 1.2.6. Other Toxicological Effects .............................................................................................. 1-72 1.3. INTEGRATION AND EVALUATION ............................................................................................... 1-72 1.3.1. Effects Other Than Cancer ............................................................................................... 1-72 1.3.2. Carcinogenicity ................................................................................................................ 1-74 1.3.3. Susceptible Populations and Lifestages for Cancer and Noncancer Outcomes .............. 1-77 2. DOSE-RESPONSE ANALYSIS ................................................................................................................. 2-1 2.1. ORAL REFERENCE DOSE FOR EFFECTS OTHER THAN CANCER ...................................................... 2-1 2.1.1. Identification of Studies and Effects for Dose-Response Analysis .................................... 2-1 2.1.2. Methods of Analysis .......................................................................................................... 2-2 2.1.3. Derivation of Candidate Values ......................................................................................... 2-4 2.1.4. Derivation of Organ/System-Specific Reference Doses .................................................... 2-8 2.1.5. Selection of the Overall Reference Dose ........................................................................... 2-8 iii Toxicological Review of tert-Butyl Alcohol (tert-Butanol) 2.1.6. Confidence Statement ....................................................................................................... 2-9 2.1.7. Previous Integrated Risk Information System (IRIS) Assessment ...................................... 2-9 2.2. INHALATION REFERENCE CONCENTRATION FOR EFFECTS OTHER THAN CANCER ....................... 2-9 2.2.1. Identification of Studies and Effects for Dose-Response Analysis .................................... 2-9 2.2.2. Methods of Analysis ........................................................................................................ 2-10 2.2.3. Derivation of Candidate Values ....................................................................................... 2-15 2.2.4. Derivation of Organ/System-Specific Reference Concentrations ................................... 2-18 2.2.5. Selection of the Overall Reference Concentration .......................................................... 2-18 2.2.6. Confidence Statement ..................................................................................................... 2-19 2.2.7. Previous Integrated Risk Information System (IRIS) Assessment .................................... 2-19 2.2.8. Uncertainties in the Derivation of the Reference Dose and Reference Concentration .................................................................................................................. 2-19 2.3. ORAL SLOPE FACTOR FOR CANCER ............................................................................................. 2-20 2.3.1. Analysis of Carcinogenicity Data ..................................................................................... 2-20 2.3.2. Dose-Response Analysis―Adjustments and Extrapolations Methods ........................... 2-21 2.3.3. Derivation of the Oral Slope Factor ................................................................................. 2-23 2.3.4. Uncertainties in the Derivation of the Oral Slope Factor ................................................ 2-24 2.3.5. Previous Integrated Risk Information System (IRIS) Assessment .................................... 2-26 2.4. INHALATION UNIT RISK FOR CANCER ......................................................................................... 2-26 2.4.1. Previous Integrated Risk Information System (IRIS) Assessment .................................... 2-27 2.5. APPLICATION OF AGE-DEPENDENT ADJUSTMENT FACTORS ...................................................... 2-27 REFERENCES ............................................................................................................................................... R-1 SUPPLEMENTAL INFORMATION ............................................................................................. (see Volume 2) iv Toxicological Review of tert-Butyl Alcohol (tert-Butanol) TABLES Table ES-1. Organ/system-specific oral reference doses (RfDs) and overall RfD for tert-butanol ......... xxvii Table ES-2. Organ/system-specific inhalation reference concentrations (RfCs) and overall RfC for tert-butanol ................................................................................................................... xxviii Table LS-1. Details of the search strategy employed for tert-butanol ................................................... xxxvi Table LS-2. Summary of additional search strategies for tert-butanol ................................................. xxxvii Table LS-3. Inclusion-exclusion criteria ................................................................................................ xxxviii Table LS-4. Considerations for evaluation of experimental animal studies................................................ xli Table LS-5. Summary of experimental animal evidence base ................................................................... xlii Table 1-1. Chemical identity and physicochemical properties of tert-Butanol as curated by EPA’s CompTox Chemicals Dashboard ...................................................................................... 1-2 Table 1-2. Changes in kidney histopathology in animals following exposure to tert-butanol ............... 1-15 Table 1-3. Changes in kidney tumors in animals following exposure to tert-butanol ............................ 1-19 Table 1-4. Comparison of nephropathy and suppurative inflammation in individual male rats from the 2-year National Toxicology Program (NTP) tert-butanol bioassay ................. 1-21 Table 1-5. Comparison of nephropathy and suppurative inflammation in individual female rats from the 2-year National Toxicology Program (NTP) tert-butanol bioassay ................. 1-21 Table 1-6. Comparison of nephropathy and transitional epithelial hyperplasia in individual male rats from the 2-year National Toxicology Program (NTP) tert-butanol bioassay .......... 1-21 Table 1-7. Comparison of nephropathy and transitional epithelial hyperplasia in individual female rats from the 2-year National Toxicology Program (NTP) tert-butanol bioassay ........................................................................................................................
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