Review of Exposure Data and Assessments for Select Dialkyl
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TABLE OF CONTENTS 1. INTRODUCTION ........................................................................................................... 1-1 2. PRODUCTION AND USE OF PHTHALATES ............................................................. 2-1 2.1. PRODUCTION OF PHTHALATES ................................................................... 2-1 2.1.1. Production of DEHP ................................................................................ 2-1 2.1.2. Production of DBP ................................................................................... 2-2 2.1.3. Production of BBP ................................................................................... 2-2 2.1.4. Production of DINP ................................................................................. 2-3 2.1.5. Production of DIDP ................................................................................. 2-3 2.1.6. Production of DnOP ................................................................................. 2-4 2.2. USE OF PHTHALATES ..................................................................................... 2-4 3. PHYSICO-CHEMICAL AND ENVRONMENTAL FATE PROPERTIES OF PHTHALATES ................................................................................. 3-1 3.1. PHYSICO-CHEMICAL PROPERTIES OF PHTHALATES ............................. 3-1 3.1.1. Benzyl butyl phthalate (BBP) .................................................................. 3-1 3.1.2. Di-n-butyl phthalate (DBP) ...................................................................... 3-1 3.1.3. Bis(2-ethylhexyl) phthalate (DEHP)........................................................ 3-2 3.1.4. Di-isodecyl phthalate (DIDP) .................................................................. 3-2 3.1.5. Di-isononyl phthalate (DINP) .................................................................. 3-3 3.1.6. Di-n-octyl phthalate (DnOP) .................................................................... 3-3 3.2. ENVIRONMENTAL FATE PROPERTIES OF PHTHALATES ...................... 3-4 3.2.1. Benzyl butyl phthalate (BBP) .................................................................. 3-4 3.2.2. Di-n-butyl phthalate (DBP) .................................................................... 3-11 3.2.3. Bis(2-ethylhexyl) phthalate (DEHP)...................................................... 3-12 3.2.4. Di-isodecyl phthalate (DIDP) ................................................................ 3-13 3.2.5. Di-isononyl phthalate (DINP) ................................................................ 3-13 3.2.6. Di-n-octyl phthalate (DnOP) .................................................................. 3-14 4. ENVIRONMENTAL AND CONSUMER PRODUCTS CONCENTRATIONS ........... 4-1 4.1. ENVIRONMENTAL MEDIA CONCENTRATIONS ........................................ 4-1 4.1.1. Water ...................................................................................................... 4-2 4.1.2. Soil/Sediments/Sludge/Solid Waste......................................................... 4-3 4.1.3. Air/Dust/Indoor Surfaces ......................................................................... 4-4 4.1.4. Biota ......................................................................................................... 4-6 4.2. CONSUMER PRODUCT CONCENTRATIONS .............................................. 4-8 i 4.2.1. Scenario 1: Children’s Toys and Baby Equipment ................................. 4-8 4.2.2. Scenario 2: Medical Devices .................................................................. 4-9 4.2.3. Scenario 3: Personal Care Products ........................................................ 4-9 4.2.4. Scenario 4: Clothing, Gloves and Footwear ......................................... 4-11 4.2.5. Scenario 5: Cars and Related Products ................................................. 4-11 4.2.6. Scenario 6: Building Materials ............................................................. 4-12 4.2.7. Scenario 7: Pharmaceuticals ................................................................. 4-13 4.2.8. Scenario 8: Adult Toys and Gels .......................................................... 4-13 4.2.9. Scenario 9: Other Products ................................................................... 4-13 4.3. FOOD AND FOOD RELATED PRODUCTS .................................................. 4-14 5. HUMAN EXPOSURE TO PHTHALATES .................................................................... 5-1 5.1. GENERAL OVERVIEW..................................................................................... 5-1 5.2. BIOMONITORING ............................................................................................. 5-1 5.2.1. Urine ...................................................................................................... 5-4 5.2.2. Blood .................................................................................................... 5-13 5.2.3. Human Milk ........................................................................................... 5-14 5.2.4. Saliva .................................................................................................... 5-15 5.2.5. Seminal Fluids ....................................................................................... 5-15 5.2.6. Multiple Biological Media ..................................................................... 5-16 5.3. OCCUPATIONAL EXPOSURE ....................................................................... 5-17 5.3.1. Summary of Occupational Inhalation and Dermal Exposures ............... 5-17 5.3.2. Occupational Inhalation and Dermal Exposure ..................................... 5-22 5.4. CONSUMER EXPOSURE ................................................................................ 5-34 5.4.1. Introduction ........................................................................................... 5-34 5.4.2. Scenario 1: Toys and Baby Equipment ................................................ 5-39 5.4.3. Scenario 2: Medical Devices ................................................................ 5-56 5.4.4. Scenario 3: Personal Care Products ..................................................... 5-66 5.4.5. Scenario 4: Clothing, Gloves, and Footwear ....................................... 5-69 5.4.6. Scenario 5: Car and Public Transportation Interior ............................. 5-71 5.4.7. Scenario 6: Building Materials and Furniture ...................................... 5-72 5.4.8. Scenario 7: Food and Food-Related Uses ............................................ 5-76 5.4.9. Scenario 8: Pharmaceuticals ................................................................ 5-88 5.4.10. Scenario 9: Adult Toys and Pleasure Gels ........................................... 5-89 5.4.11. Scenario 10: Miscellaneous ................................................................... 5-91 5.5. HUMANS EXPOSED VIA THE ENVIRONMENT ........................................ 5-92 5.6. CUMULATIVE EXPOSURE ......................................................................... 5-100 5.6.1. Introduction .......................................................................................... 5-100 5.6.2. Description of the Biomonitoring Approach to Calculating ii Cumulative Exposure .......................................................................... 5-105 5.6.3. Description of the Indirect Scenario Approach to Calculating Cumulative Exposure ........................................................................... 5-113 5.6.4. Cumulative Exposure Estimates for Banned Phthalates ...................... 5-117 5.6.4.1. DEHP ..................................................................................... 5-117 5.6.4.2. DBP ........................................................................................ 5-125 5.6.4.3. BBP ........................................................................................ 5-131 5.6.5. Cumulative Exposure for Interim Banned Phthalates .......................... 5-135 5.6.5.1. DINP ...................................................................................... 5-136 5.6.5.2. DIDP ...................................................................................... 5-139 5.6.5.3. DnOP...................................................................................... 5-141 5.6.6. Cumulative Exposure for Other Phthalates (Not Banned or Interim Banned) ............................................................................... 5-142 5.6.6.1. DMP ....................................................................................... 5-142 5.6.6.2. DEP ........................................................................................ 5-145 5.6.6.3. DiBP ....................................................................................... 5-148 5.6.6.4. DCHP ..................................................................................... 5-150 5.7. POPULATIONS WITH HIGH PHTHALATE EXPOSURE.......................... 5-151 5.8. UNCERTAINTY AND DATA LIMITATIONS ............................................. 5-153 6. CONCLUSIONS.............................................................................................................. 6-1 7. REFERENCES CITED .................................................................................................... 7-1 iii LIST OF TABLES Table 3.1-1. Physico-Chemical Properties of BBP ............................................................... 3-5 Table 3.1-2. Physico-Chemical