EPA Document# EPA-740-D-20-015 April 2020 United States Office of Chemical Safety and Environmental Protection Agency Pollution Prevention Draft Scope of the Risk Evaluation for Butyl Benzyl Phthalate (1,2-Benzenedicarboxylic acid, 1-butyl 2-(phenylmethyl) ester) CASRN 85-68-7 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 of TSCA Submissions ................................................................................................ 18 2.2 Conditions of Use ........................................................................................................................19 Categories and Subcategories of Conditions of Use Included in the Scope of the Risk Evaluation .............................................................................................................................. 20 Activities Excluded from the Scope of the Risk Evaluation ................................................. 23 Production Volume ................................................................................................................ 23 Overview of Conditions of Use and Lifecycle Diagram ....................................................... 24 2.3 Exposures ....................................................................................................................................26 Physical and Chemical Properties ......................................................................................... 26 Environmental Fate and Transport ........................................................................................ 26 Releases to the Environment ................................................................................................. 26 Environmental Exposures ...................................................................................................... 26 Occupational Exposures ........................................................................................................ 27 Consumer Exposures ............................................................................................................. 28 General Population Exposures ............................................................................................... 28 2.4 Hazards (Effects) .........................................................................................................................29 Environmental Hazards ......................................................................................................... 29 Human Health Hazards .......................................................................................................... 29 2.5 Potentially Exposed or Susceptible Subpopulations ...................................................................29 2.6 Conceptual Models ......................................................................................................................30 Conceptual Model for Industrial and Commercial Activities and Uses ................................ 30 Conceptual Model for Consumer Activities and Uses .......................................................... 32 Conceptual Model for Environmental Releases and Wastes: Potential Exposures and Hazards (Regulatory Overlay) ............................................................................................... 34 2.6.3.1 Ambient Water Pathway ................................................................................................. 36 2.6.3.2 Disposal and Soil Pathways ............................................................................................ 36 Conceptual Model for Environmental Releases and Wastes: Potential Exposures and Hazards .................................................................................................................................. 37 2.7 Analysis Plan ...............................................................................................................................40 Physical and Chemical Properties and Environmental Fate .................................................. 40 Exposure ................................................................................................................................ 40 2.7.2.1 Environmental Releases ................................................................................................. 41 2.7.2.2 Environmental Exposures ............................................................................................... 42 2.7.2.3 Occupational Exposures ................................................................................................. 43 2.7.2.4 Consumer Exposures ...................................................................................................... 45 2.7.2.5 General Population ......................................................................................................... 46 2 Hazards (Effects) ................................................................................................................... 48 2.7.3.1 Environmental Hazards .................................................................................................. 48 2.7.3.2 Human Health Hazards ................................................................................................... 49 Summary of Risk Approaches for Characterization .............................................................. 51 2.8 Peer Review .................................................................................................................................52 REFERENCES ..........................................................................................................................................53 APPENDICES ...........................................................................................................................................59 LIST OF GRAY LITERATURE SOURCES ................................................................... 59 PHYSICAL AND CHEMICAL PROPERTIES ............................................................... 63 ENVIRONMENTAL FATE AND TRANSPORT PROPERTIES .................................. 65 REGULATORY HISTORY ............................................................................................. 67 PROCESS, RELEASE AND OCCUPATIONAL EXPOSURE INFORMATION ......... 73 E.1.1 Manufacturing (Including Import) ..........................................................................................73 E.1.1.1 Domestic Manufacturing .................................................................................................73 E.1.1.2 Import ..............................................................................................................................73 E.1.2 Processing and Distribution ....................................................................................................73 E.1.2.1 Reactant or Intermediate ..................................................................................................73 E.1.2.2 Incorporated into a Formulation, Mixture or Reaction Product ......................................74 E.1.2.3 Incorporated into an Article .............................................................................................74 E.1.2.4 Repackaging ....................................................................................................................74 E.1.2.5 Recycling .........................................................................................................................74 E.1.3 Uses .........................................................................................................................................74 E.1.3.1 Adhesives, Sealants, Paints, and Coatings ......................................................................74 E.1.3.2 Automotive Products .......................................................................................................75 E.1.3.3 Building/Construction Materials Not Covered Elsewhere ..............................................75 E.1.3.4 Ink, Toner, and Colorant Products ..................................................................................75 E.1.3.5 Plastic and Rubber Products ............................................................................................75 E.1.3.6 Other Uses .......................................................................................................................75 E.1.4 Disposal ..................................................................................................................................75