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Chronic Hazard Advisory Panel on Phthalates and Phthalate Alternatives

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Chronic Hazard Advisory Panel on Phthalates and Phthalate Alternatives Report to the U.S. Consumer Product Safety Commission by the CHRONIC HAZARD ADVISORY PANEL ON PHTHALATES AND PHTHALATE ALTERNATIVES July 2014 U.S. Consumer Product Safety Commission Directorate for Health Sciences Bethesda, MD 20814 Chronic Hazard Advisory Panel on Phthalates and Phthalate Alternatives Chris Gennings, Ph.D. Virginia Commonwealth University Richmond, VA Russ Hauser, M.D., Sc.D., M.P.H. Harvard School of Public Health Boston, MA Holger M. Koch, Ph.D. Ruhr University Bochum, Germany Andreas Kortenkamp, Ph.D. Brunel University London, United Kingdom Paul J. Lioy, Ph.D. Robert Wood Johnson Medical School Piscataway, NJ Philip E. Mirkes, Ph.D. University of Washington (retired) Seattle, WA Bernard A. Schwetz, D.V.M., Ph.D. Department of Health and Human Services (retired) Washington, DC TABLE OF CONTENTS LIST OF TABLES ....................................................................................................................... iv LIST OF FIGURES ..................................................................................................................... vi ABBREVIATIONS ..................................................................................................................... vii 1 Executive Summary .............................................................................................................. 1 2 Background and Strategy................................................................................................... 11 2.1 Introduction and Strategy Definition ............................................................................ 11 2.2 Selection of Toxicity Endpoints and Life Cycle Stages ............................................... 13 2.2.1 The Rat Phthalate Syndrome ................................................................................................ 15 2.2.2 The Phthalate Syndrome in Other Species (excluding humans) .......................................... 16 2.2.3 Mechanism of Phthalate Action ........................................................................................... 18 2.3 Toxicology Data............................................................................................................ 19 2.3.1 Use of Animal Data to Assess Hazard and Risk .................................................................. 19 2.3.2 Developmental Toxicity of Phthalates in Rats ..................................................................... 22 2.3.3 Reproductive and Other Toxicity Data ................................................................................ 25 2.3.4 Cumulative Exposure Considerations .................................................................................. 26 2.4 Epidemiology ................................................................................................................ 27 2.4.1 Phthalates and Male Reproductive Tract Developmental Outcomes ................................... 28 2.4.2 Phthalates and Neurodevelopmental Outcomes ................................................................... 29 2.5 Human Biomonitoring ................................................................................................. 34 2.5.1 Introduction .......................................................................................................................... 34 2.5.2 Objectives ............................................................................................................................. 34 2.5.3 Methodology ........................................................................................................................ 35 2.5.4 Results .................................................................................................................................. 36 2.5.5 Conclusion ........................................................................................................................... 37 2.6 Scenario-Based Exposure Assessment ......................................................................... 49 2.6.1 Introduction .......................................................................................................................... 49 2.6.2 Objectives ............................................................................................................................. 49 2.6.3 Methodology ........................................................................................................................ 50 2.6.4 Results .................................................................................................................................. 50 2.6.5 Phthalate Substitutes ............................................................................................................ 51 2.6.6 Summary of Design.............................................................................................................. 52 2.6.7 Conclusions .......................................................................................................................... 52 2.6.8 General Conclusion and Comment ...................................................................................... 53 2.7 Cumulative Risk Assessment ........................................................................................ 61 2.7.1 Choice of Approach for Cumulative Risk Assessment ........................................................ 61 2.7.2 Summary Description of Methods Used .............................................................................. 63 2.7.3 Summary Results ................................................................................................................. 64 i 3 Phthalate Risk Assessment ................................................................................................. 68 4 Discussion............................................................................................................................. 71 4.1 Variability and Uncertainty........................................................................................... 71 4.1.1 Developmental/Reproductive Toxicity Data ........................................................................ 71 4.1.2 Exposure Scenarios .............................................................................................................. 72 4.1.3 HBM Data, Daily Intake Calculations, Hazard Index Calculations ..................................... 73 4.2 Species Differences in Metabolism, Sensitivity, and Mechanism ................................ 75 5 Recommendations ............................................................................................................... 79 5.1 Criteria for Recommendations ...................................................................................... 79 5.2 Recommendations on Permanently Banned Phthalates ................................................ 82 5.2.1 Di-n-butyl Phthalate (DBP) (84-74-2) ................................................................................. 82 5.2.2 Butylbenzyl Phthalate (BBP) (85-68-7) ............................................................................... 85 5.2.3 Di(2-ethylhexyl) Phthalate (DEHP) (117-81-7) ................................................................... 88 5.3 Recommendations on Interim Banned Phthalates ........................................................ 91 5.3.1 Di-n-octyl Phthalate (DNOP) (117-84-0) ............................................................................ 91 5.3.2 Diisononyl Phthalate (DINP) (28553-12-0 and 68515-48-0) .............................................. 95 5.3.3 Diisodecyl Phthalate (DIDP) (26761-40-0 and 68515-49-1) ............................................. 100 5.4 Recommendations on Phthalates Not Banned ............................................................ 105 5.4.1 Dimethyl Phthalate (DMP) (131-11-3) .............................................................................. 105 5.4.2 Diethyl Phthalate (DEP) (84-66-2) .................................................................................... 107 5.4.3 Diisobutyl Phthalate (DIBP) (84-69-5) .............................................................................. 110 5.4.4 Di-n-pentyl Phthalate (DPENP) (131-18-0) ....................................................................... 112 5.4.5 Di-n-hexyl Phthalate (DHEXP) (84-75-3) ......................................................................... 114 5.4.6 Dicyclohexyl Phthalate (DCHP) (84-61-7) ........................................................................ 116 5.4.7 Diisooctyl Phthalate (DIOP) (27554-26-3) ........................................................................ 118 5.4.8 Di(2-propylheptyl) Phthalate (DPHP) CAS 53306-54-0 ................................................... 120 5.5 Recommendations on Phthalate Substitutes ............................................................... 121 5.5.1 2,2,4-trimethyl-1,3 pentanediol diisobutyrate (TPIB) (6846-50-0) ................................... 121 5.5.2 Di(2-ethylhexyl) adipate (DEHA) CAS 103-23-1 ............................................................. 125 5.5.3 Di(2-ethylhexyl) terephthalate (DEHT) CAS 6422-86-2 ................................................... 129 5.5.4 Acetyl Tributyl Citrate (ATBC) CAS 77-90-7 .................................................................. 133 5.5.5 Diisononyl hexahydrophthalate (DINX) CAS 166412-78-8.............................................. 135 5.5.6 Tris(2-ethylhexyl) trimellitate (TOTM) CAS 3319-31-1 ..................................................
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