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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-17/015b External Review Draft www.epa.gov/iris Toxicological Review of tert-Butyl Alcohol (tert-Butanol) (CASRN 75-65-0) Supplemental Information June 2017 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. Integrated Risk Information System National Center for Environmental Assessment Office of Research and Development U.S. Environmental Protection Agency Washington, DC Supplemental Information―tert-Butyl Alcohol 1 DISCLAIMER 2 This document is a preliminary draft for review purposes only. This information is 3 distributed solely for the purpose of pre-dissemination peer review under applicable information 4 quality guidelines. It has not been formally disseminated by EPA. It does not represent and should 5 not be construed to represent any Agency determination or policy. Mention of trade names or 6 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 ii DRAFT—DO NOT CITE OR QUOTE Supplemental Information―tert-Butyl Alcohol 1 2 CONTENTS 3 APPENDIX A. ASSESSMENTS BY OTHER NATIONAL AND INTERNATIONAL HEALTH AGENCIES ............ A-1 4 APPENDIX B. INFORMATION IN SUPPORT OF HAZARD IDENTIFICATION AND DOSE-RESPONSE 5 ANALYSIS .......................................................................................................................... B-1 6 B.1. TOXICOKINETICS ..................................................................................................... B-1 7 Absorption................................................................................................. B-1 8 Distribution ............................................................................................... B-2 9 Metabolism ............................................................................................... B-2 10 Excretion ................................................................................................... B-5 11 Physiologically Based Pharmacokinetic Models ....................................... B-7 12 PBPK Model Code ...................................................................................... B-8 13 B.2. OTHER PERTINENT TOXICITY INFORMATION ......................................................... B-9 14 Other Toxicological Effects ........................................................................ B-9 15 Genotoxicity ............................................................................................ B-22 16 Summary ................................................................................................. B-26 17 APPENDIX C. DOSE-RESPONSE MODELING FOR THE DERIVATION OF REFERENCE VALUES FOR 18 EFFECTS OTHER THAN CANCER AND THE DERIVATION OF CANCER RISK 19 ESTIMATES ....................................................................................................................... C-1 20 Noncancer Endpoints ................................................................................ C-1 21 Cancer Endpoints .................................................................................... C-23 22 APPENDIX D. SUMMARY OF PUBLIC COMMENTS AND EPA’s DISPOSITION ........................................ D-1 23 REFERENCES ......................................................................................................................................... R-1 24 This document is a draft for review purposes only and does not constitute Agency policy. iii DRAFT—DO NOT CITE OR QUOTE Supplemental Information―tert-Butyl Alcohol 1 TABLES 2 Table A-1. Health assessments and regulatory limits by other national and international 3 health agencies .................................................................................................................... A-1 4 Table B-1. Changes in kidney weight in animals following exposure to tert-butanol ............................. B-11 5 Table B-2. Changes in liver weight in animals following exposure to tert-butanol ................................. B-14 6 Table B-3. Changes in liver histopathology in animals following exposure to tert-butanol .................... B-16 7 Table B-4. Changes in urinary bladder histopathology in animals following oral exposure to 8 tert-butanol ......................................................................................................................... B-18 9 Table B-5. Summary of genotoxicity (both in vitro and in vivo) studies of tert-butanol ......................... B-25 10 Table C-1. Noncancer endpoints selected for dose-response modeling for tert-butanol ......................... C-2 11 Table C-2. Summary of BMD modeling results for kidney transitional epithelial hyperplasia in 12 male F344 rats exposed to tert-butanol in drinking water for 2 years (NTP, 13 1995); BMR = 10% extra risk ................................................................................................. C-3 14 Table C-3. Summary of BMD modeling results for kidney transitional epithelial hyperplasia in 15 female F344 rats exposed to tert-butanol in drinking water for 2 years (NTP, 16 1995); BMR = 10% extra risk ................................................................................................. C-6 17 Table C-4. Summary of BMD modeling results for absolute kidney weight in male F344 rats 18 exposed to tert-butanol in drinking water for 15 months (NTP, 1995); BMR = 19 10% rel. dev. from control mean .......................................................................................... C-9 20 Table C-5. Summary of BMD modeling results for absolute kidney weight in female F344 rats 21 exposed to tert-butanol in drinking water for 15 months (NTP, 1995); BMR = 22 10% rel. dev. from control mean ........................................................................................ C-12 23 Table C-6. Summary of BMD modeling results for kidney inflammation in female rats 24 exposed to tert-butanol in drinking water for 2 years (NTP, 1995); BMR = 10% 25 extra risk .............................................................................................................................. C-15 26 Table C-7. Summary of BMD modeling results for absolute kidney weight in male F344 rats 27 exposed to tert-butanol via inhalation for 6 hr/d, 5d/wk for 13 weeks (NTP, 28 1997); BMR = 10% relative deviation from the mean ......................................................... C-18 29 Table C-8. Summary of BMD modeling results for absolute kidney weight in female F344 rats 30 exposed to tert-butanol via inhalation for 6 hr/d, 5d/wk for 13 weeks (NTP, 31 1997); BMR = 10% relative deviation from the mean ......................................................... C-21 32 Table C-9. Cancer endpoints selected for dose-response modeling for tert-butanol ............................. C-24 33 Table C-10. Summary of the oral slope factor derivations ...................................................................... C-25 34 Table C-11. Summary of BMD modeling results for thyroid follicular cell adenomas in female 35 B6C3F1 mice exposed to tert-butanol in drinking water for 2 years (NTP, 1995); 36 BMR = 10% extra risk .......................................................................................................... C-26 37 Table C-12. Summary of BMD modeling results for thyroid follicular cell adenomas or 38 carcinomas in male B6C3F1 mice exposed to tert-butanol in drinking water for 39 2 years (NTP, 1995); BMR = 5% extra risk ........................................................................... C-29 40 Table C-13. Summary of BMD modeling results for thyroid follicular cell adenomas or 41 carcinomas in male B6C3F1 mice exposed to tert-butanol in drinking water for 42 2 years, high dose omitted (NTP, 1995); BMR = 5% extra risk ............................................ C-32 43 Table C-14. Summary of BMD modeling results for renal tubule adenoma or carcinoma in 44 male F344 rats exposed to tert-butanol in drinking water for 2 years modeled 45 with administered dose units and including all dose groups (NTP, 1995); BMR 46 = 10% extra risk ................................................................................................................ C-35 This document is a draft for review purposes only and does not constitute Agency policy. iv DRAFT—DO NOT CITE OR QUOTE Supplemental Information―tert-Butyl Alcohol 1 Table C-15. Summary of BMD modeling results for renal tubule adenoma or carcinoma in 2 male F344 rats exposed to tert-butanol in drinking water for 2 years modeled 3 with administered dose units and excluding high-dose group (NTP, 1995); BMR 4 = 10% extra risk. .................................................................................................................. C-37 5 Table C-16. Summary of BMD modeling results for renal tubule adenoma or carcinoma in 6 male F344 rats exposed to tert-butanol in drinking water for 2 years modeled 7 with administered dose units and including all dose groups; reanalyzed data 8 (Hard et al., 2011; NTP, 1995); BMR = 10% extra risk ......................................................... C-39 9 Table C-17. Summary of BMD modeling results for renal tubule adenoma or
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