EPA Document# EPA-740-R-20-015 August 2020 United States Office of Chemical Safety and Environmental Protection Agency Pollution Prevention Final Scope of the Risk Evaluation for Butyl Benzyl Phthalate (1,2-Benzenedicarboxylic acid, 1-butyl 2-(phenylmethyl) ester) CASRN 85-68-7 August 2020 TABLE OF CONTENTS ACKNOWLEDGEMENTS ......................................................................................................................6 ABBREVIATIONS AND ACRONYMS ..................................................................................................7 EXECUTIVE SUMMARY .....................................................................................................................10 1 INTRODUCTION ............................................................................................................................12 2 SCOPE OF THE EVALUATION ...................................................................................................13 2.1 Reasonably Available Information ..............................................................................................13 Search of Gray Literature ...................................................................................................... 14 Search of Literature from Publicly Available Databases (Peer-reviewed Literature) ........... 15 Search of TSCA Submissions ................................................................................................ 24 2.2 Conditions of Use ........................................................................................................................25 Categories and Subcategories of Conditions of Use Included in the Scope of the Risk Evaluation .............................................................................................................................. 26 Activities Excluded from the Scope of the Risk Evaluation ................................................. 29 Production Volume ................................................................................................................ 30 Overview of Conditions of Use and Lifecycle Diagram ....................................................... 30 2.3 Exposures ....................................................................................................................................32 Physical and Chemical Properties ......................................................................................... 32 Environmental Fate and Transport ........................................................................................ 34 Releases to the Environment ................................................................................................. 34 Environmental Exposures ...................................................................................................... 35 Occupational Exposures ........................................................................................................ 35 Consumer Exposures ............................................................................................................. 36 General Population Exposures ............................................................................................... 36 2.4 Hazards (Effects) .........................................................................................................................36 Environmental Hazards ......................................................................................................... 36 Human Health Hazards .......................................................................................................... 37 2.5 Potentially Exposed or Susceptible Subpopulations ...................................................................37 2.6 Conceptual Models ......................................................................................................................38 Conceptual Model for Industrial and Commercial Activities and Uses: Potential Exposures and Hazards ........................................................................................................................... 38 Conceptual Model for Consumer Activities and Uses .......................................................... 40 Conceptual Model for Environmental Releases and Wastes: Potential Exposures and Hazards (Regulatory Overlay) ............................................................................................... 42 2.6.3.1 Exposure Pathways and Risks Addressed by Other EPA Administered Statutes .......... 44 2.6.3.2 Conceptual Model for Environmental Releases and Wastes: Potential Exposures and Hazards .......................................................................................................................... 50 2.7 Analysis Plan ...............................................................................................................................52 Physical and Chemical Properties and Environmental Fate .................................................. 52 Exposure ................................................................................................................................ 53 2.7.2.1 Environmental Releases ................................................................................................. 53 2.7.2.2 Environmental Exposures ............................................................................................... 55 2.7.2.3 Occupational Exposures ................................................................................................. 56 2.7.2.4 Consumer Exposures ...................................................................................................... 57 2.7.2.5 General Population ......................................................................................................... 59 2 Hazards (Effects) ................................................................................................................... 60 2.7.3.1 Environmental Hazards .................................................................................................. 60 2.7.3.2 Human Health Hazards ................................................................................................... 62 Summary of Risk Approaches for Characterization .............................................................. 64 2.8 Peer Review .................................................................................................................................65 REFERENCES .........................................................................................................................................66 APPENDICES ..........................................................................................................................................71 A.1.1 Search Term Genesis and Chemical Verification ...................................................................71 A.1.2 Publicly Available Database Searches ....................................................................................72 A.1.2.1 Query Strings for the Publicly-Available Database Searches on Butyl Benzyl Phthalate ..............................................................................................................................73 A.1.2.2 Data Prioritization for Environmental Hazard, Human Health Hazard, Fate and Physical Chemistry .............................................................................................................78 A.1.2.3 Data Prioritization for Occupational Exposures and Environmental Releases and General Population, Consumer and Environmental Exposures ...........................79 A.2.1 Inclusion/Exclusion Criteria ...................................................................................................79 A.2.1.1 PECO for Environmental and Human Health Hazards ...................................................80 A.2.1.2 PECO for Consumer, Environmental, and General Population Exposures. ....................82 A.2.1.3 RESO for Occupational Exposure and Environmental Releases ....................................83 A.2.1.4 PESO for Fate and Transport ..........................................................................................85 A.2.1.5 Generation of Hazard Heat Maps ....................................................................................88 A.3.1 Screening of Gray Literature ..................................................................................................89 A.3.2 Initial Screening of Sources using Decision Logic Tree ........................................................89 A.3.3 TSCA Submission Searching and Title Screening .................................................................90 A.3.4 Gray Literature Search Results for Butyl Benzyl Phthalate ...................................................91 E.1.1 Manufacturing (Including Import) ........................................................................................104 E.1.1.1 Domestic Manufacturing ...............................................................................................104 E.1.1.2 Import 104 E.1.2 Processing and Distribution ..................................................................................................104 E.1.2.1 Incorporated into a Formulation, Mixture or Reaction Product ....................................104 E.1.2.2 Incorporated into an Article ...........................................................................................105 E.1.2.3 Repackaging ..................................................................................................................105