EPA Document# EPA-740-D-20-016 April 2020 United States Office of Chemical Safety and Environmental Protection Agency Pollution Prevention Draft Scope of the Risk Evaluation for Dibutyl Phthalate (1,2-Benzenedicarboxylic acid, 1,2-dibutyl ester) CASRN 84-74-2 April 2020 TABLE OF CONTENTS ACKNOWLEDGEMENTS ......................................................................................................................5 ABBREVIATIONS AND ACRONYMS ..................................................................................................6 EXECUTIVE SUMMARY .......................................................................................................................9 1 INTRODUCTION ............................................................................................................................12 2 SCOPE OF THE EVALUATION ...................................................................................................12 2.1 Reasonably Available Information ..............................................................................................12 Search of Gray Literature ...................................................................................................... 13 Search of Literature from Publicly Available Databases (Peer-reviewed Literature) ........... 14 Search Results for TSCA Submissions .................................................................................. 18 2.2 Conditions of Use ........................................................................................................................19 Categories and Subcategories of Conditions of Use Included in the Scope of the Risk Evaluation .............................................................................................................................. 19 Activities Excluded from the Scope of the Risk Evaluation ................................................. 23 Production Volume ................................................................................................................ 23 Overview of Conditions of Use and Lifecycle Diagram ....................................................... 23 2.3 Exposures ....................................................................................................................................25 Physical and Chemical (P-Chem) Properties ......................................................................... 25 Environmental Fate and Transport ........................................................................................ 25 Releases to the Environment ................................................................................................. 25 Environmental Exposures ...................................................................................................... 27 Occupational Exposures ........................................................................................................ 27 Consumer Exposures ............................................................................................................. 28 General Population Exposures ............................................................................................... 29 2.4 Hazards (Effects) .........................................................................................................................30 Environmental Hazards ......................................................................................................... 30 Human Health Hazards .......................................................................................................... 30 2.5 Potentially Exposed or Susceptible Subpopulations ...................................................................30 2.6 Conceptual Models ......................................................................................................................31 Conceptual Model for Industrial and Commercial Activities and Uses ................................ 31 Conceptual Model for Consumer Activities and Uses .......................................................... 33 Conceptual Model for Environmental Releases and Wastes: Potential Exposures and Hazards (Regulatory Overlay) ............................................................................................... 35 2.6.3.1 Ambient Air Pathway ..................................................................................................... 37 2.6.3.2 Ambient Water Pathway ................................................................................................. 37 2.6.3.3 Disposal and Soil Pathways ............................................................................................ 38 Conceptual Model for Environmental Releases and Wastes: Potential Exposures and Hazards .................................................................................................................................. 39 2.7 Analysis Plan ...............................................................................................................................41 P-Chem Properties and Environmental Fate .......................................................................... 41 Exposure ................................................................................................................................ 41 2.7.2.1 Environmental Releases ................................................................................................. 42 2.7.2.2 Environmental Exposures ............................................................................................... 44 2.7.2.3 Occupational Exposures ................................................................................................. 45 2.7.2.4 Consumer Exposures ...................................................................................................... 46 2 2.7.2.5 General Population ......................................................................................................... 48 Hazards (Effects) ................................................................................................................... 50 2.7.3.1 Environmental Hazards .................................................................................................. 50 2.7.3.2 Human Health Hazards ................................................................................................... 51 Summary of Risk Approaches for Characterization .............................................................. 53 2.8 Peer Review .................................................................................................................................54 REFERENCES .........................................................................................................................................55 APPENDICES ..........................................................................................................................................61 LIST OF GRAY LITERATURE SOURCES .............................................................. 61 PHYSICAL AND CHEMICAL PROPERTIES OF DIBUTYL PHTHALATE ...... 64 ENVIRONMENTAL FATE AND TRANSPORT PROPERTIES ............................ 66 REGULATORY HISTORY .......................................................................................... 68 PROCESS, RELEASE AND OCCUPATIONAL EXPOSURE INFORMATION .. 78 E.1.1 Manufacture (Including Import) .............................................................................................78 E.1.1.1 Domestic Manufacturing .................................................................................................78 E.1.1.2 Import ..............................................................................................................................78 E.1.2 Processing and Distribution ....................................................................................................78 E.1.2.1 Reactant or Intermediate ..................................................................................................78 E.1.2.2 Incorporated into a Formulation, Mixture or Reaction Product ......................................79 E.1.2.3 Incorporated into an Article .............................................................................................79 E.1.2.1 Repackaging ....................................................................................................................79 E.1.2.2 Recycling .........................................................................................................................79 E.1.3 Uses .........................................................................................................................................79 E.1.3.1 Adhesives, Sealants, Paints, and Coatings ......................................................................79 E.1.3.2 Building/Construction Materials Not Covered Elsewhere ..............................................80 E.1.3.3 Cleaning and Furnishings Care Products ........................................................................80 E.1.3.4 Ink, Toner, and Colorant Products ..................................................................................80 E.1.3.5 Plastic and Rubber Products ............................................................................................80 E.1.3.6 Other Uses .......................................................................................................................81 E.1.4 Disposal ..................................................................................................................................81