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Crotonaldehyde, Trans EPA/690/R-21/001F | March 2021 | FINAL Provisional Peer-Reviewed Toxicity Values for trans-Crotonaldehyde (CASRN 123-73-9) U.S. EPA Office of Research and Development Center for Public Health and Environmental Assessment EPA/690/R-21/001F March 2021 https://www.epa.gov/pprtv Provisional Peer-Reviewed Toxicity Values for trans-Crotonaldehyde (CASRN 123-73-9) Center for Public Health and Environmental Assessment Office of Research and Development U.S. Environmental Protection Agency Cincinnati, OH 45268 AUTHORS, CONTRIBUTORS, AND REVIEWERS CHEMICAL MANAGER Jeffry L. Dean II, PhD Center for Public Health and Environmental Assessment, Cincinnati, OH DRAFT DOCUMENT PREPARED BY SRC, Inc. 7502 Round Pond Road North Syracuse, NY 13212 PRIMARY INTERNAL REVIEWERS J. Andre Weaver, PhD Center for Public Health and Environmental Assessment, Research Triangle Park, NC J. Phillip Kaiser, PhD, DABT Center for Public Health and Environmental Assessment, Cincinnati, OH PRIMARY EXTERNAL REVIEWERS Eastern Research Group, Inc. 110 Hartwell Avenue Lexington, MA 02421-3136 PPRTV PROGRAM MANAGEMENT Teresa L. Shannon Center for Public Health and Environmental Assessment, Cincinnati, OH J. Phillip Kaiser, PhD, DABT Center for Public Health and Environmental Assessment, Cincinnati, OH Questions regarding the content of this PPRTV assessment should be directed to the U.S. EPA Office of Research and Development (ORD) Center for Public Health and Environmental Assessment (CPHEA) website at https://ecomments.epa.gov/pprtv. iii trans-Crotonaldehyde TABLE OF CONTENTS COMMONLY USED ABBREVIATIONS AND ACRONYMS ................................................... v BACKGROUND ............................................................................................................................ 1 QUALITY ASSURANCE .............................................................................................................. 1 DISCLAIMERS .............................................................................................................................. 2 QUESTIONS REGARDING PPRTVs ........................................................................................... 2 INTRODUCTION .......................................................................................................................... 3 METHODS ................................................................................................................................. 7 Literature Search ..................................................................................................................... 7 Screening Process ................................................................................................................... 7 LITERATURE SEARCH AND SCREENING RESULTS........................................................ 8 REVIEW OF POTENTIALLY RELEVANT DATA (NONCANCER AND CANCER) ............. 9 HUMAN STUDIES .................................................................................................................. 13 ANIMAL STUDIES ................................................................................................................. 13 Oral Exposures ...................................................................................................................... 13 Inhalation Exposures ............................................................................................................. 18 OTHER DATA (SHORT-TERM TESTS, OTHER EXAMINATIONS) ................................ 18 Genotoxicity Studies ............................................................................................................. 18 Supporting Animal Toxicity Studies..................................................................................... 25 Absorption, Distribution, Metabolism, and Excretion Studies ............................................. 30 Mode-of-Action/Mechanistic Studies ................................................................................... 31 DERIVATION OF PROVISIONAL VALUES ........................................................................... 32 DERIVATION OF PROVISIONAL ORAL REFERENCE DOSES....................................... 32 Derivation of a Subchronic Provisional Reference Dose ..................................................... 32 Derivation of a Chronic Provisional Reference Dose ........................................................... 35 DERIVATION OF INHALATION REFERENCE CONCENTRATIONS ............................. 37 Summary of Noncancer Provisional Reference Values ............................................................ 37 PROVISIONAL CARCINOGENICITY ASSESSMENT ....................................................... 38 APPENDIX A. LITERATURE SEARCH STRATEGY.............................................................. 39 APPENDIX B. DETAILED PECO CRITERIA ........................................................................... 41 APPENDIX C. SCREENING PROVISIONAL VALUES .......................................................... 42 APPENDIX D. DATA TABLES .................................................................................................. 43 APPENDIX E. BENCHMARK DOSE MODELING RESULTS ................................................ 49 APPENDIX F. REFERENCES .................................................................................................... 58 iv trans-Crotonaldehyde COMMONLY USED ABBREVIATIONS AND ACRONYMS α2u-g alpha 2u-globulin LC50 median lethal concentration ACGIH American Conference of Governmental LD50 median lethal dose Industrial Hygienists LOAEL lowest-observed-adverse-effect level AIC Akaike’s information criterion MN micronuclei ALD approximate lethal dosage MNPCE micronucleated polychromatic ALT alanine aminotransferase erythrocyte AR androgen receptor MOA mode of action AST aspartate aminotransferase MTD maximum tolerated dose atm atmosphere NAG N-acetyl-β-D-glucosaminidase ATSDR Agency for Toxic Substances and NCI National Cancer Institute Disease Registry NOAEL no-observed-adverse-effect level BMC benchmark concentration NTP National Toxicology Program BMCL benchmark concentration lower NZW New Zealand White (rabbit breed) confidence limit OCT ornithine carbamoyl transferase BMD benchmark dose ORD Office of Research and Development BMDL benchmark dose lower confidence limit PBPK physiologically based pharmacokinetic BMDS Benchmark Dose Software PCNA proliferating cell nuclear antigen BMR benchmark response PND postnatal day BUN blood urea nitrogen POD point of departure BW body weight PODADJ duration-adjusted POD CA chromosomal aberration QSAR quantitative structure-activity CAS Chemical Abstracts Service relationship CASRN Chemical Abstracts Service registry RBC red blood cell number RDS replicative DNA synthesis CBI covalent binding index RfC inhalation reference concentration CHO Chinese hamster ovary (cell line cells) RfD oral reference dose CL confidence limit RGDR regional gas dose ratio CNS central nervous system RNA ribonucleic acid CPHEA Center for Public Health and SAR structure activity relationship Environmental Assessment SCE sister chromatid exchange CPN chronic progressive nephropathy SD standard deviation CYP450 cytochrome P450 SDH sorbitol dehydrogenase DAF dosimetric adjustment factor SE standard error DEN diethylnitrosamine SGOT serum glutamic oxaloacetic DMSO dimethylsulfoxide transaminase, also known as AST DNA deoxyribonucleic acid SGPT serum glutamic pyruvic transaminase, EPA Environmental Protection Agency also known as ALT ER estrogen receptor SSD systemic scleroderma FDA Food and Drug Administration TCA trichloroacetic acid FEV1 forced expiratory volume of 1 second TCE trichloroethylene GD gestation day TWA time-weighted average GDH glutamate dehydrogenase UF uncertainty factor GGT γ-glutamyl transferase UFA interspecies uncertainty factor GSH glutathione UFC composite uncertainty factor GST glutathione-S-transferase UFD database uncertainty factor Hb/g-A animal blood-gas partition coefficient UFH intraspecies uncertainty factor Hb/g-H human blood-gas partition coefficient UFL LOAEL-to-NOAEL uncertainty factor HEC human equivalent concentration UFS subchronic-to-chronic uncertainty factor HED human equivalent dose U.S. United States of America i.p. intraperitoneal WBC white blood cell IRIS Integrated Risk Information System IVF in vitro fertilization Abbreviations and acronyms not listed on this page are defined upon first use in the PPRTV document. v trans-Crotonaldehyde EPA/690/R-21/001F PROVISIONAL PEER-REVIEWED TOXICITY VALUES FOR TRANS-CROTONALDEHYDE (CASRN 123-73-9) BACKGROUND A Provisional Peer-Reviewed Toxicity Value (PPRTV) is defined as a toxicity value derived for use in the Superfund Program. PPRTVs are derived after a review of the relevant scientific literature using established Agency guidance on human health toxicity value derivations. The purpose of this document is to provide support for the hazard and dose-response assessment pertaining to chronic and subchronic exposures to substances of concern, to present the major conclusions reached in the hazard identification and derivation of the PPRTVs, and to characterize the overall confidence in these conclusions and toxicity values. It is not intended to be a comprehensive treatise on the chemical or toxicological nature of this substance. Currently available PPRTV assessments can be accessed on the U.S. Environmental Protection Agency’s (EPA’s) PPRTV website at https://www.epa.gov/pprtv. PPRTV assessments are eligible to be updated on a 5-year
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