CPSC Staff Statement on the Toxicology Excellence for Risk Assessment Report, “Exposure Assessment: Composition, Production, and Use of Phthalates” August 2015
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CPSC Staff Statement on the Toxicology Excellence for Risk Assessment Report, “Exposure Assessment: Composition, Production, and Use of Phthalates” August 2015 The report, Exposure Assessment: Composition, Production, and Use of Phthalates, presents the findings of research conducted by Toxicology Excellence for Risk Assessment (“TERA”) under a contract with the U.S. Consumer Product Safety Commission (“CPSC”). TERA performed this research to characterize composition, manufacturing processes, and applications of 11 specified phthalates. The phthalates researched are: • DEHP: di-(2-ethylhexyl) phthalate • DBP: dibutyl phthalate • BBP: benzyl butyl phthalate • DINP: diisononyl phthalate • DIDP: diisodecyl phthalate • DnOP: di-n-octyl phthalate • DIOP: diisooctyl phthalate • DIBP: diisobutyl phthalate • DPENP: di-n-pentyl phthalate • DHEXP: di-n-hexyl phthalate • DCHP: dicyclohexyl phthalate This research was completed in support of CPSC’s work on third party testing burden reduction consistent with assuring compliance. CPSC staff will consider this information in evaluating whether staff could make a recommendation for a Commission determination that some materials do not contain any of the 11 phthalates in concentrations above 0.1 percent, and thus, may not require third party testing to assure compliance with section 108 of the Consumer Product Safety Improvement Act of 2008. This report will be posted on CPSC’s website to keep stakeholders informed of the progress of technical research related to the agency’s regulatory activities. Exposure Assessment: Composition, Production, And Use of Phthalates Task Order 11 Contract Number CPSC-D-12-0001 July 15, 2015 Revised Report Prepared by: Toxicology Excellence for Risk Assessment (TERA) University of Cincinnati Contact: Patricia McGinnis [email protected] Stephen Thiel [email protected] Jeanelle Martinez [email protected] Alison Willis [email protected] Bernard Gadagbui [email protected] Douglas Lee [email protected] Amina Darwish [email protected] Abbreviation List ........................................................................................................................... ix 1 Introduction ............................................................................................................................. 1 2 Literature Review Strategy ..................................................................................................... 3 2.1 Tier 1, Secondary Literature............................................................................................. 4 2.2 Tier 2, Reviewing Secondary Sources ........................................................................... 11 2.3 Tier 3, Gap Searching..................................................................................................... 13 3 Di-(2-ethylhexyl) phthalate (DEHP) CASRN: 117-81-7 ................................................... 17 3.1 Raw Materials Used in Production of DEHP ................................................................. 17 3.2 Chemical and Physical Properties of DEHP .................................................................. 18 3.3 Worldwide Manufacturing Processes for DEHP ........................................................... 20 3.4 Annual Production of DEHP .......................................................................................... 21 3.5 Application of DEHP in Materials, Consumer Products and Nonconsumer Products .. 22 3.5.1 Children’s Products ................................................................................................. 23 3.5.2 Other Products ........................................................................................................ 30 3.6 Routes of Introduction of DEHP into Phthalate-Free Material ...................................... 33 3.7 References ...................................................................................................................... 36 4 Dibutyl phthalate (DBP) CASRN: 84-74-2 ........................................................................ 42 4.1 Raw Materials used in Production of DBP .................................................................... 42 4.2 Chemical and Physical Properties of DBP ..................................................................... 43 4.3 Worldwide Manufacturing Processes for DBP .............................................................. 45 4.4 Annual Production of DBP ............................................................................................ 45 4.5 Application of DBP in Materials, Consumer Products and Nonconsumer Products ..... 47 4.5.1 Children’s Products ................................................................................................. 47 4.5.2 Other Products ........................................................................................................ 51 4.6 Routes of Introduction of DBP into Phthalate-free Material ......................................... 53 4.7 References ...................................................................................................................... 54 5 Benzyl butyl phthalate (BBP) CASRN: 85-68-7 ................................................................ 58 5.1 Raw Materials Used in Production of BBP .................................................................... 58 5.2 Chemical and Physical Properties of BBP ..................................................................... 59 5.3 Worldwide Manufacturing Processes for BBP .............................................................. 61 5.4 Annual Production of BBP ............................................................................................. 61 ii 5.5 Application of BBP in Materials, Consumer Products and Nonconsumer Products ..... 62 5.5.1 Child Care Products ................................................................................................ 63 5.5.2 Other Products ........................................................................................................ 65 5.6 Routes of Introduction of BBP into Phthalate-free Material.......................................... 66 5.7 References ...................................................................................................................... 67 6 Di-isononyl phthalate (DINP) CASRN: 28553-12-0, 68515-40-0 ...................................... 72 6.1 Raw Materials Used in Production of DINP .................................................................. 72 6.2 Chemical and Physical Properties of DINP ................................................................... 73 6.3 Worldwide Manufacturing Processes for DINP............................................................. 75 6.4 Annual Production of DINP ........................................................................................... 76 6.5 Application of DINP in Materials, Consumer Products and Nonconsumer Products ... 77 6.5.1 Children’s Products ................................................................................................. 77 6.5.2 Other Products ....................................................................................................... 88 6.6 Routes of Introduction of DINP into Phthalate-free Material ........................................ 90 6.7 References ...................................................................................................................... 91 7 Diisodecyl phthalate (DIDP) CASRN: 26761-40-0, 68515-49-1 ........................................ 98 7.1 Raw Materials Used in Production of DIDP .................................................................. 98 7.2 Chemical and Physical Properties of DIDP ................................................................... 98 7.3 Worldwide Manufacturing of DIDP ............................................................................ 101 7.4 Annual Production of DIDP ......................................................................................... 101 7.5 Applications for DIDP in Materials, Consumer Products and Nonconsumer Products102 7.5.1 Child Care Products .............................................................................................. 102 7.5.2 Other Products ...................................................................................................... 105 7.6 Routes of Introduction of DIDP into Phthalate-free Material ...................................... 108 7.7 References .................................................................................................................... 109 8 Di-n-Octyl Phthalate (DnOP) CASRN: 117-84-0 ............................................................ 111 8.1 Raw Materials Used in Production of DnOP ............................................................... 111 8.2 Chemical and Physical Properties of DnOP ................................................................. 111 8.3 Worldwide Manufacturing Processes of DnOP ........................................................... 113 8.4 Annual Production of DnOP ........................................................................................ 114 8.5 Application of DnOP in Materials, Consumer Products and Nonconsumer Products . 114 iii 8.5.1 Children’s Products ............................................................................................... 114 8.5.2 Other Products ...................................................................................................... 116 8.6 Routes of Introduction