United States Office of Chemical Safety and Environmental Protection Agency Pollution Prevention Proposed Designation of Di-isobutyl Phthalate (DIBP) (CASRN 84-69-5) as High-Priority Substance for Risk Evaluation August 22,2019 ------- Table of Contents List of Tables iii Acronyms and Abbreviations iv 1. Introduction 1 2. Production volume or significant changes in production volume 3 Approach 3 Results and Discussion 3 3. Conditions of use or significant changes in conditions of use 4 Approach 4 CDR Tables 4 CDR Summary and Additional Information on Conditions of Use 6 4. Potentially exposed or susceptible subpopulations 7 Approach 7 Results and Discussion 7 5. Persistence and bioaccumulation 8 Approach 8 Physical and Chemical Properties and Environmental Fate Tables 8 Results and Discussion 10 6. Storage near significant sources of drinking water 10 Approach 10 Results and Discussion 11 7. Hazard potential 11 Approach 11 Potential Human Health and Environmental Hazard Tables 11 8. Exposure potential 14 Approach 14 Results and Discussion 14 9. Other risk-based criteria that EPA determines to be relevant to the designation of the chemical substance's priority 15 10. Proposed designation and Rationale 17 11. References 18 ii ------- List of Tables Table 1. 1986-2015 National Aggregate Production Volume Data (Production Volume in Pounds) 3 Table 2. Di-isobutyl phthalate (84-69-5) Categories and Subcategories of Conditions of Use (2016 CDR Reporting Cycle) 5 Table 3. Di-isobutyl phthalate (84-69-5) Categories and Subcategories of Conditions of Use (2012 CDR Reporting Cycle) 6 Table 4. Physical and Chemical Properties of Di-isobutyl Phthalate 8 Table 5. Environmental Fate Characteristics of Di-isobutyl Phthalate 9 Table 6. Potential Human Health Hazards Identified for Di-isobutyl Phthalate 12 Table 7. Potential Environmental Hazards Identified for Di-isobutyl Phthalate 13 Table 8. Exposure Information for Consumers 15 Table 9. Exposure Information for the Environment and General Population 16 in ------- Acronyms and Abbreviations Term Description ACGIH American Conference of Governmental Industrial Hygienists AGD Anogenital Distance AGI Anogenital Index BAF Bioaccumulation Factor BCF Bioconcentration Factor CAA Clean Air Act CBI Confidential Business Information CDR Chemical Data Reporting CERCLA Comprehensive Environmental Response, Compensation and Liability Act CFR U.S. Code of Federal Regulations CHAP Chronic Hazard Advisory Panel CPDat Chemical and Products Database CPSC U.S. Consumer Product Safety Commission CWA Clean Water Act DIBP Di-isobutyl Phthalate EPCRA Emergency Planning and Community Right-to-Know Act IUR Inventory Update Reporting K Thousand M Million MIBP Monoisobutyl Phthalate NHANES National Health and Nutrition Examination Survey NICNAS National Industrial Chemicals Notification and Assessment Scheme (Australia) NIH National Institutes of Health (NIH) NIOSH National Institute for Occupational Safety and Health OECD Organisation for Economic Co-operation and Development OSHA Occupational Safety and Health Administration PEL Permissible Exposure Limit iv ------- PPE Personal Protective Equipment REL Recommended Exposure Limit TBD To be determined TLV Threshold Limit Value TSCA Toxic Substances Control Act TRI Toxics Release Inventory WH Withheld V ------- 1. Introduction In section 6(b)(1)(B) of the Toxic Substances Control Act (TSCA), as amended, and in the U.S. Environmental Protection Agency's (EPA) implementing regulations (40 CFR 702.3)1, a high- priority substance for risk evaluation is defined as a chemical substance that EPA determines, without consideration of costs or other non-risk factors, may present an unreasonable risk of injury to health or the environment because of a potential hazard and a potential route of exposure under the conditions of use, including an unreasonable risk to potentially exposed or susceptible subpopulations identified as relevant by EPA. Before designating prioritization status, under EPA's regulations at 40 CFR 702.9 and pursuant to TSCA section 6(b)(1)(A), EPA will generally use reasonably available information to screen the candidate chemical substance under its conditions of use against the following criteria and considerations: • the hazard and exposure potential of the chemical substance; • persistence and bioaccumulation; • potentially exposed or susceptible subpopulations; • storage near significant sources of drinking water; • conditions of use or significant changes in the conditions of use of the chemical substance; • the chemical substance's production volume or significant changes in production volume; and • other risk-based criteria that EPA determines to be relevant to the designation of the chemical substance's priority. This document presents the review of the candidate chemical substance against the criteria and considerations set forth in 40 CFR 702.9 for a may present risk finding. The information sources used are relevant to the criteria and considerations and consistent with the scientific standards of TSCA section 26(h), including, as appropriate, sources for hazard and exposure data listed in Appendices A and B of the TSCA Work Plan Chemicals: Methods Document (February 2012) (40 CFR 702.9(b)). EPA uses scientific information that is consistent with the best available science. Final designation of the chemical substance as a high-priority chemical substance would immediately initiate the risk evaluation process as described in the EPA's final rule, Procedures for Chemical Risk Evaluation Under the Amended Toxic Substances Control Act (40 CFR 702). Di-isobutyl phthalate (DIBP) is one of the 40 chemical substances initiated for prioritization as referenced in the March 21, 2019 notice (84 FR 10491)2. EPA has determined that DIBP is a suitable candidate for the proposed designation as a high-priority substance. The proposed designation is based on the results of the review against the aforementioned criteria and considerations as well as review of the reasonably available information on DIBP, including relevant information received from the public and other information as appropriate. 1 For all 40 CFR 702 citations, please refer to: https://www.govinfo.gov/content/pkg/CFR-2018-title40-vol33/xml/CFR-2018-title40-vol33-part702.xml and https://www. regulations. gov/document?D=EPA~HQ~OPPT~2Q .1.6-0654-01.08 2 https://www.federalregister.gov/documents/2019/03/21/2019-05404/initiation-of-prioritization-under-the-toxic- substances-co nt ro 1-act-tsca 1 ------- EPA will take comment on this proposed designation for 90 days before finalizing its designation of DIBP. The docket number for providing comments on DIBP is EPA-HQ-OPPT-2018-0434 and is available at www.regulations.gov. The information, analysis and basis used for the review of the chemical is organized as follows: • Section 1 (Introduction): This section explains the requirements of the amended TSCA and implementing regulations - including the criteria and considerations - pertinent to the prioritization and designation of high-priority chemical substances. • Section 2 (Production volume or significant changes in production volume): This section presents information and analysis on national aggregate production volume of the chemical substance. • Section 3 (Conditions of use or significant changes in conditions of use): This section presents information and analysis regarding the chemical substance's conditions of use under TSCA. • Section 4 (Potentially exposed or susceptible subpopulations): This section presents information and analysis regarding potentially exposed or susceptible subpopulations, including children, women of reproductive age, and workers, with respect to the chemical substance. • Section 5 (Persistence and bioaccumulation): This section presents information and analysis regarding the physical and chemical properties of the chemical substance and the chemical's fate characteristics. • Section 6 (Storage near significant sources of drinking water): This section presents information and analysis considered regarding the risk from the storage of the chemical substance near significant sources of drinking water. • Section 7 (Hazardpotential): This section presents the hazard information relevant to the chemical substance. • Section 8 (Exposurepotential): This section presents information and analysis regarding the exposures to the chemical substance. • Section 9 (Other risk-based criteria): This section presents the extent to which EPA identified other risk-based criteria that are relevant to the designation of the chemical substance's priority. • Section 10 (Proposed designation): Based on the results of the review performed and the information and analysis presented, this section describes the basis used by EPA to support the proposed designation. 2 ------- 2. Production volume or significant changes in production volume Approach EPA considered current volume or significant changes in volume of the chemical substance using information reported by manufacturers (including importers). EPA assembled reported information for years 1986 through 2015 on the production volume for DIBP reported under the Inventory Update Reporting (IUR) rule and Chemical Data Reporting (CDR) rule3. The national aggregate production volume, which is presented as a range to protect individual site production volumes that are confidential business information (CBI), is presented in Table 1. Results and Discussion National aggregate production volume for DIBP generally declined from 1986 to 2011, after which this information was withheld. From 1986 to 1998, aggregate production volume was between 1 million and 10 million pounds. In 2002 and 2006, aggregate production volume was between 500 thousand and 1 million pounds, and in reporting year 2011, 453,710 pounds of this chemical was manufactured or produced (Table 1). Table 1.1986-2015 National Aggregate Production Volume Data (Production Volume in Pounds) Chemical ID 1986 1990 1994 1998 2002 2006 2011 2012 2013 2014 2015 Di-isobutyl >1M >1M >1M >1M >500K >500K 453,710 WH WH WH WH Phthalate to to to to to 1M to 1M (84-69-5) 10M 10M 10M 10M K = thousand, M = million, WH = withheld4 Reference: U.S. EPA (2013) and U.S. EPA ( 3 Over time, the requirements for reporting frequency, production volume thresholds, and chemical substances under the Chemical Data Reporting (CDR) rule have changed. CDR was formerly known as the Inventory Update Rule (IUR). The first IUR collection occurred in 1986 and continued every four years through 2006. As part of two rulemakings in 2003 and 2005, EPA made a variety of changes to the IUR, including to change the reporting frequency to every five years to address burdens associated with new reporting requirements. Additional changes to reporting requirements were made in 2011, including to suspend and replace the 2011 submission period with a 2012 submission period, return to reporting every four years, and require the reporting of all years beginning with 2011 production volumes. The reporting of production volumes for all years was added because of the mounting evidence that many chemical substances, even larger production volume chemical substances, often experience wide fluctuations in production volume from year to year. In addition, also as part of the 2011 IUR Modifications final rule (76 FR 50816, Aug 16, 2011), EPA changed the name of the regulation from IUR to CDR to better reflect the distinction between this data collection (which includes exposure-related data) and the TSCA Inventory itself (which only involves chemical identification information). 4 This information is withheld, because EPA is releasing the 2016 CDR data in stages. EPA released the initial 2016 CDR data in May 2017. The initial data included national production volume (released in ranges), other manufacturing information, and processing and use information, except for information claimed by the submitter to be confidential business information (CBI) or information that EPA is withholding to protect claims of CBI. EPA anticipates releasing additional data after completion of an effort to obtain CBI substantiation required by the Frank R. Lautenberg Chemical Safety for the 21st Century Act, which amended the Toxic Substances Control Act. 3 ------- 3. Conditions of use or significant changes in conditions of use Approach EPA assembled information to determine conditions of use or significant changes in conditions of use of the chemical substance. TSCA section 3(4) defines the term "conditions of use" to mean the circumstances, as determined by the Administrator, under which a chemical substance is intended, known, or reasonably foreseen to be manufactured, processed, distributed in commerce, used, or disposed of. A key source of reasonably available information that EPA considered for determining the conditions of use for DIBP was submitted by manufacturers (including importers) under the 2012 and 2016 CDR reporting cycles. CDR requires manufacturers (including importers) to report information on the chemical substances they produce domestically or import into the United States greater than 25,000 lbs per site, except if certain TSCA actions apply (in which case the reporting requirement is greater than 2,500 lbs per site). CDR includes information on the manufacturing, processing, and use of chemical substances. Based on the known manufacturing, processing and uses of this chemical substance, EPA assumes distribution in commerce. CDR may not provide information on other life-cycle phases such as distribution or chemical end-of-life after use in products (i.e., disposal). While EPA may be aware of additional uses, CDR submitters are not required to provide information on chemical uses that are not regulated under TSCA. For chemical substances under review that are included on the Toxics Release Inventory (TRI) chemical list, information disclosed by reporting facilities in Part II Section 3 ("Activities and Uses of the Toxic Chemical at the Facility") of their TRI Form R reports was used to supplement the CDR information on conditions of use. There is not a one-to-one correlation between conditions of use reported under CDR and information reported in Part II Section 3 of the TRI Form R because facilities are not required to disclose in their Form R submissions the specific uses of TRI chemical substances they manufactured on-site or imported. DIBP is not included on the TRI chemical list. For purposes of this proposed prioritization designation, EPA assumed end-of-life pathways that include releases to air, wastewater, and solid and liquid waste based on the conditions of use. CDR Tables Based on the publicly available5 manufacturing information, industrial processing and use information, and consumer and commercial use information reported under CDR, EPA developed a list of conditions of use for the 2016 and 2012 reporting cycles (Tables 2 and 3, respectively). 5 Some specific chemical uses may be claimed by CDR submitters as confidential business information (CBI) under section 14 of TSCA. In these cases, EPA has indicated that the information is CBI. 4 ------- Table 2. Di-isobutyl phthalate (84-69-5) Categories and Subcategories of Conditions of Use6 (2016 CDR Report ting Cycle) Life-Cycle Stage Category Subcategory Reference Manufacturing Domestic manufacturing Domestic manufacturing t; -s HIM {20 19) Manufacturing Import Import 10 19) Processing Incorporating into article Plasticizers - construction; plastics product manufacturing; transportation equipment manufacturing U.S. EPA. (20 19) Processing Incorporating into formulation, mixture, or reaction product Plasticizers - adhesive manufacturing; plastics product manufacturing ! ^ M \ v20tr0 Distribution in Commuvc'1'' Distribution in com mcicc Commercial Uses Adhesives and sealants Adhesives and sealants >01<- - Commercial Uses Plastic and rubber products not covered elsewhere Plastic and rubber products not covered elsewhere ! ^ n \ v20tr0 Consumer Uses Adhesives and sealants Adhesives and sealants i r W \ v-Oi Disposal:i Disposal 11 CDR includes information on the manufacturing, processing, and use of chemicals. CDR may not provide information on other life-cycle phases such as distribution or chemical end-of-life after use in products (i.e., disposal). The table row is highlighted in gray to indicate that no information is provided for this life-cycle stage. b EPA is particularly interested in information from the public on distribution in commerce. 6 Certain other uses that are excluded from TSCA are not captured in this table. 5 ------- Table 3. Di-isobutyl phthalate (84-69-5) Categories and Subcategories of Conditions of Use7 (2012 CDR Report ting Cycle) Life-Cycle Stage Category Subcategory Reference Manufacturing Domestic manufacturing Domestic manufacturing Processing Incorporating into formulation, mixture, or reaction product Solvents (which become part of product formulation or mixture) - plastics material and resin manufacturing Distribution in Coninicive1'' Distribution in commuvc Commuvial I scs Disposal:i Catalyst sol\cut Disposal Catalyst sol\cut a CDR includes information on the manufacturing, processing, and use of chemicals. CDR may not provide information on other life-cycle phases such as distribution or chemical end-of-life after use in products (i.e., disposal). The table row is highlighted in gray to indicate that no information is provided for this life-cycle stage. b EPA is particularly interested in information from the public on distribution in commerce. CDR Summary and Additional Information on Conditions of Use There was an increase in reporting conditions of use for DIBP from the 2012 to 2016 CDR cycle. In the 2016 CDR data, one site reported use of DIBP in consumer and commercial adhesives and sealants, and another site reported use of this chemical in commercial plastic and rubber products, neither of which was reported in 2012. In the 2012 CDR data, only one site reported a commercial use of DIBP as a catalyst solvent. One site reported a single industrial use of DIBP in the 2012 CDR cycle for plastic material and resin manufacturing. A single site reported the same use in 2016, albeit for the functional category of plasticizers instead of solvents. Use of DIBP for industrial adhesive and transportation equipment manufacturing and construction was also reported in 2016. In the 2016 CDR data, two facilities reported that DIBP was not recycled (e.g., remanufactured, reprocessed, or reused). In the 2012 CDR data, one facility reported that DIBP was not recycled. Consumer uses were also identified in additional databases, which are included in the Exposure Potential section (Section 8). One public commenter (EPA-HQ-OPPT-2018-0434-0004) asserted that DIBP is present as an additive and impurity in adhesives in amounts less than 0.1 percent. Another commenter (EPA- HQ-OPPT-2018-0434-0005) mentioned that DIBP is often a by-product or intermediate in the production of phthalate-containing plastics. Should the Agency decide to make a final decision to designate this chemical substance as a high-priority substance, further characterization of relevant TSCA conditions of use will be undertaken as part of the process of developing the scope of the risk evaluation. 7 Certain other uses that are excluded from TSCA are not captured in this table. 6 ------- 4. Potentially exposed or susceptible subpopulations Approach In this review, EPA considered reasonably available information to identify potentially exposed or susceptible subpopulations, such as children, women of reproductive age, workers, consumers, or the elderly. EPA analyzed processing and use information included on the CDR Form U. These data provide an indication about whether children may be potentially exposed or other susceptible subpopulations may be exposed. EPA also used human health hazard information to identify potentially exposed or susceptible subpopulations. Results and Discussion At this stage, EPA identified children, women of reproductive age, consumers and workers as subpopulations who may be potentially exposed or susceptible subpopulations for DIBP. Children EPA used data reported to the 2012 and 2016 CDR to identify uses in products and articles intended for children over time for DIBP. The 2012 and 2016 CDR did not report any use of DIBP in children's products. EPA also identified potential developmental hazards that would impact any stage of children's development. Women of reproductive age (e.g., pregnant women per TSCA statute) EPA identified studies that observed developmental and reproductive effects following exposure to DIBP (Section 7, Table 6). Thus, women of reproductive age were identified as a potentially exposed or susceptible subpopulation. Consideration of women of reproductive age as a potentially exposed or susceptible subpopulation was also based on exposure because women of reproductive age are potential workers in the manufacturing, processing, distribution in commerce, use, or disposal of the chemical substance. Workers Please refer to the Exposure Potential section (Section 8) for summary of potential occupational exposures, which EPA indicates that workers are potentially exposed or susceptible subpopulations based on greater exposure. Consumers Please refer to the Exposure Potential section (Section 8) for summary of potential consumer exposures, which EPA indicates that consumers are potentially exposed or susceptible subpopulations based on greater exposure. 7 ------- 5. Persistence and bioaccumulation Approach EPA reviewed reasonably available information, such as physical and chemical properties and environmental fate characteristics, to understand DIBP's persistence and bioaccumulation. Physical and Chemical Properties and Environmental Fate Tables Tables 4 and 5 summarize the physical and chemical properties and the environmental fate characteristics of DIBP, respectively. Table 4. Physica and Chemical Properties of Di-isobut tyl Phthalate Property or Endpoint Value3 Reference Molecular Formula C16H22O4 CRC Handbook (Haynes, 2014) Molecular Weight 278.344 g/mole CRC Handbook (Haynes, 2014) Physical State Liquid CRC Handbook (Haynes, 2014) Physical Form Liquid HSDB C citing Lewis (2007) Purity >99%; impurities include water HSDB C citing CPSC (2011) Melting Point -64 °C Phvsoroo (2 Boiling Point 296.5 °C PhvsoroD (2012); HSDB C citing CRC Handbook (Haynes, 2014) Density 1.049 g/cm3 HSDB C citing Havnes (2010); CRC Handbook (Haynes, 2014) Vapor Pressure 4.76 x 10"5 at 25 °C HSDB C citing Daubert and Danner (1989) Vapor Density TBD TBD Water Solubility 6.2 mg/L at 24 °Cb PhvsProo (2012); HSDB ( citing Yalkowsky et al. (2010) 11.5 mg/Lat-25 °C ECHA (2019) Log Kow 4.11 HSDB (2013) citing Hansch et al. (1995) Henry's Law Constant 2.8 x 10"6 atm-m3/mole (calculated from measured vapor pressure and water solubility) EPI Suite (2 Flash Point 185 °C (open cup) HSDB C citing NFPA (2010) 8 ------- Property or Endpoint Value3 Reference Auto Flammability 432 °C (autoignition temperature) H.SDB C citing NFPA f201 (» Viscosity 41 mPa • second at 20 °C HSDBC citing Gerhartz r 1985") Refractive Index 1.49 at 25 °C H.SDB C citing Lewis (2007) Dielectric Constant TBD TBD Surface Tension TBD TBD Notes: aMeasured unless otherwise noted; bSelected value TBD = To be determined, if reasonably available. EPA is particularly interested in information from the public on these properties or endpoints. Table 5. Environmental Fate Characteristics of Di-isobutyl Pht lalate Property or Endpoint Value3 Reference Direct Photodegradati on May be susceptible due to potential absorption HSDB C Indirect Photodegradati on ti/2 = 1.2 days (12-hour day at 1.5 x 106 OH/cm3) based on OH rate constant of 9.3 x 10"12 cm3/molecule-second at 25 °C; estimated)11 EPI Suite (2 Hydrolysis ti/2 = 5,730 days (at pH = 8, based on a rate constant of 0.0014 M"1 second"1) Wolfe etal. (1980) Biodegradation (Aerobic) 98%/4 weeks (OECD 302C) HSDB ('. citing Sedvkh and Klopman (2007) 100%/6 days (die-away tests) HSDB C citing Hattori etal. (1975) 40%/28 days OECD 301B (C02 evolution) ECHA (20 i 9) Biodegradation (Anaerobic) 0-30%/96 days (sewage sludge and swamp water) 0-30%/56 days (marine sediment) HSDB L •. ; i citing Madsen et al. (1995) Wastewater Treatment 99.5% total removal (92% by biodegradation, 7.5% by sludge adsorption, and 0% by volatilization to air; estimated)11 EPI Suite (2 9 ------- Property or Endpoint Value3 Reference Bioconcentration Factor 240 (log BCF = 2.4; estimated)13 EPI Suite (2012) Bioaccumulation Factor 26 (log BAF = 1.4; estimated)13 EPI Suite (2 Soil Organic Carbon:Water Partition Coefficient (Log Koc) 3.14 HSDB C citing Sabliic etal. (1995) Notes: "Measured unless otherwise noted bEPI Suite™ physical property inputs: Log Kow = 4.11, BP = 296.5 °C, MP = -64 °C, VP = 4.76 x 10 5 mm Hg, WS = 6.2 mg/L, BioP = 4, BioA = 1, Bio S = 1 SMILES 0=C(0CC(C)C)c(c(cccl)C(=0)0CC(C)C)cl Bioconcentration factor = BCF; Bioaccumulation factor = BAF Results and Discussion DIBP is a volatile liquid. Based on its vapor pressure (4.76 x 10"5 mm Hg) and calculated Henry's Law constant (2.8 x 10"6 atm-m3/mole), DIBP is expected to volatilize from water and moist soil surfaces, but not dry soils. It is expected to have low mobility in soil (log Koc 3.14). DIBP is expected to biodegrade based on studies that demonstrated 98% degradation of DIBP in 4 weeks (OECD 302C) and 100% degradation in 6 days (die-away test). DIBP in the air will be in the particulate and vapor phases and is expected to react with hydroxyl radicals at a rate that corresponds to a half-life of 1.2 days. Additionally, respective estimated BCF and BAF values of 240 and 26, and a measured log Kow of 4.11 indicate that DIBP has low potential to bioaccumulate. 6. Storage near significant sources of drinking water Approach To support the proposed designation, EPA screened each chemical substance under its conditions of use with respect to the seven criteria in TSCA section 6(b)(1)(A) and 40 CFR 702.9. The statute specifically requires the Agency to consider the chemical substance's storage near significant sources of drinking water, which EPA interprets as direction to focus on the chemical substance's potential human health hazard and exposure. EPA reviewed reasonably available information, specifically looking to identify certain types of existing regulations or protections for the proposed chemical substances. EPA considered the chemical substance's potential human health hazards, including to potentially exposed or susceptible subpopulations, by identifying existing National Primary Drinking Water Regulations under the Safe Drinking Water Act (40 CFR Part 141) and regulations under the Clean Water Act (CWA; 40 CFR 401.15). In addition, EPA considered the consolidated list of chemical substances subject to reporting requirements under the Emergency Planning and Community Right-to-Know Act (EPCRA; Section 302 Extremely Hazardous Substances and Section 313 Toxic Chemicals), the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA; Hazardous Substances), and the Clean Air Act (CAA) Section 112(r) 10 ------- (Regulated Chemicals for Accidental Release Prevention). Regulation by one of these authorities is an indication that the substance is a potential health or environmental hazard which, if released near a significant source of drinking water, could present an unreasonable risk of injury to human health or the environment. Results and Discussion As a phthalate ester, DIBP is designated as a toxic pollutant under 40 CFR 401.15, and as such, is subject to effluent limitations. Specifically, DIBP is categorized as an "aromatic organic chemical," as applicable to the process wastewater discharges resulting from the manufacture of bulk organic chemicals (40 CFR 414.70). Additionally, several states have adopted water pollution discharge programs which categorize DIBP as an "aromatic organic chemical," as applicable to the process wastewater discharges resulting from the manufacture of bulk organic chemicals, including Illinois (35 111. Adm. Code 307-2406) and Wisconsin (Wis. Adm. Code § NR 235.60). 7. Hazard potential Approach EPA considered reasonably available information from peer-reviewed assessments and databases to identify potential human health and environmental hazards for DIBP (Tables 6 and 7, respectively). Because there are very few publicly available assessments for DIBP with cited environmental hazard data, EPA used the infrastructure of ECOTOXicology knowledgebase (ECOTOX) to identify single chemical toxicity data for aquatic and terrestrial life (U.S. EPA, 2018a). It uses a comprehensive chemical-specific literature search of the open literature that is conducted according to the Standard Operating Procedures (SOPs)8. The environmental hazard information was populated in ECOTOX and is available to the public. In comparison to the approach used to survey human health hazard data, EPA also used a read-across approach to identify additional environmental hazard data for isomers of DIBP, if available, to fill in potential data gaps when there were no reported observed effects for specific taxa exposed to the DIBP (Table 7). Potential Human Health and Environmental Hazard Tables EPA identified human health and environmental hazards based on a review of the reasonable available information on DIBP (Tables 6 and 7, respectively). 8 The ECOTOX Standard Operating Procedures (SOPs) can be found at: https://cfpub.epa.gov/ecotox/help.cfm?helptabs=tab4 11 ------- Table 6. Potential Human Health Hazards Identified for Di-isobutyl Phthalate Human Health Hazards Tested for Specific Effect Effect Observed Reference Acute Toxicity X NICNAS (2.008a); NICNAS t CPSC (2011); NICNAS (2008b) Repeated Dose Toxicity X X cpscIjorKmcMAsJimi Genetic Toxicity X NICNAS (2.008a); NICNAS O*l I NICNAS (2008b) Reproductive Toxicity X X NICNAS (2008a); NICNAS C CPSC (2011); CPSC (2014); NICNAS (2.008b) Developmental Toxicity X X NICNAS (2.008a); NICNAS C CPSC (201 l);CPSv .J'Ml NICNAS (2008b) Toxicokinetic X NICNAS (2008a); CPSC ( CPSC (2014) Irritation/Corrosion X NICNAS (2.008a); NICNAS C CPSC (2011); NICNAS (2008b) Dermal Sensitization X cpscT^Ti^cNAsTio^br^' Respiratory Sensitization X CPSC (2 Carcinogenicity X NICNAS (2008a); NICNAS C CPSC (2011); NICNAS (2008b) Immunotoxicity Neurotoxicity X CPSC (2011); CPSC C Epidemiological Studies or Biomonitoring Studies X CPSC (2014) Note: The "X" in the "Effect Observed" column indicates when a hazard effect was reported by one or more of the referenced studies. Blank rows indicate when information was not identified during EPA's review of reasonably available information to support the proposed designation. 12 ------- Table 7. Potential Environmental Hazards Identified for Di-isobutyl Phthalate High-Priority Chemical Isomers of Candidate Di-isobutyl Phthalate (1,2- Media Study Duration Taxa Groups Di-isobutyl Phthalate (1,2- Benzene- dicarboxylic acid, 1,2- bis-(2methylpropyl) ester) (DIBP) (CASRN 84-69-5) Benzene- dicarboxylic acid, 1,2- bis-(2methylpropyl) ester) (DIBP) (CASRN 84-69-5) NONE Reference Number of Observed Number of Observed Studies Effects Studies Effects Aquatic Acute Vegetation - - exposure Invertebrate 1 X - Linden et al., 1979 Fish 1 X - Geiger et al., 1985 Non-fish vertebrate — — (i.e., amphibians, reptiles, mammals) Chronic Vegetation - - exposure Invertebrate - - Fish - - Non-fish vertebrate — — (i.e., amphibians, reptiles, mammals) Terrestrial Acute Vegetation - - exposure Invertebrate 2 X — Boyd et al. (2016); Lenoir et al. (2014) Vertebrate - - Chronic Vegetation - - exposure Invertebrate - - Vertebrate 2 X — Hardin et al. (1987); Oishi and Hiraga (1980) The dash indicates that no studies relevant for environmental hazard were identified during this initial screening and thus the "Observed Effects" column is left blank. The X in the Observed Effects column indicates when a hazard effect was reported by one or more of the referenced studies. The N/A in the Observed Effects column indicates when a hazard effect was not reported by one of the referenced studies' abstract (full reference review has not been conducted). 13 ------- 8. Exposure potential Approach EPA considered reasonably available information to screen potential environmental, worker/occupational, consumer, and general population exposures for DIBP. Release potential for environmental and human health exposure DIBP is not included on the TRI chemical list. EPA considered conditions of use reported in CDR and the physical and chemical properties to inform the release potential of DIBP. Worker/Occupational and consumer exposure EPA's approach for assessing exposure potential was to review the physical and chemical properties, conditions of use reported in CDR, and information from the National Institutes of Health Consumer Product Database and the Chemical and Products Database (CPDat) for DIBP to inform occupational and consumer exposure potential. The results of this review are detailed in the following tables. General population exposure EPA identified environmental concentration data to inform DIBP's exposure potential to the general population (Table 9). Results and Discussion Release potential for environmental and human health exposure DIBP is not included on the TRI chemical list. When chemical substances are incorporated into formulations, mixtures, or reaction products, the industrial releases may be a relatively low percentage of the production volume. Lower percentage releases occur when a high percentage of the volume is incorporated without significant process losses during its incorporation into a formulation, mixture, or product. The actual percentages, quantities, and media of releases of the reported chemical associated with this processing or use are not known. Worker/Occupational exposure Worker exposures to this chemical may be affected by many factors, including but not limited to volume produced, processed, distributed, used, and disposed of; physical form and concentration; processes of manufacture, processing, and use; chemical properties such as vapor pressure, solubility, and water partition coefficient; local temperature and humidity; and exposure controls such as engineering controls, administrative controls, and the existence of a personal protective equipment (PPE) program. DIBP does not have an Occupational Safety and Health Administration (OSHA) Permissible Exposure Limit (PEL) ( ), a National Institute for Occupational Safety and Health (NIOSH) Recommended Exposure Limit (REL) (NIOSH 2018). or the Threshold Limit Value (TLV) set by American Conference of Governmental Industrial Hygienists (ACGIH). 14 ------- DIBP has a vapor pressure of 4.76 x 10"5 mm Hg at 25 °C/77 °F. EPA assumes that inhalation exposure is negligible when vapors are generated from liquids with vapor pressures below 0.001 mm Hg at ambient room temperature conditions. DIBP is indicated as being used in adhesives and sealants. Products used as adhesive and sealants may be applied via spray or roll application methods. These methods may generate mists to which workers may be exposed. Consumer exposure CDR reporting and information from the National Institutes of Health Household Products Database do not report any use of DIBP in consumer products. However, the EPA Chemical and Products Database (C'PDat ) as well as available assessments indicate that DIBP has been used in consumer products such as adhesives, building materials, cleaners, paints, lubricants and building materials (CPSC ) (Table 8). Internal consumer exposure has been estimated to account for 0.1 to 8 (J,g/kg bodyweight per day for infants and 0.05 to 2 (J,g/kg bodyweight per day in adults (CPSC 2011). Table 8. Exposure Information for Consumers Chemical Identity Consumer Product Database Consumer Uses (List) Di-isobutyl Phthalate (84-69-5) Adhesive, automotive, automotive care, building material, catalyst, cleaner, colorant, filler, filler building material, flooring, footwear, fragrance, hardener, metal surface treatment, paint, paint binding, paint hardener, paper, photographic, plastic, plastic hardener, rubber, seal material, solvent, stain remover, toys, viscous liquid building material, wall building material Reference: CPDat General population exposure A review of the available literature suggests that environmental concentration data are available (Table 9). Releases of DIBP from certain conditions of use, such as manufacturing, disposal, or waste treatment activities, may result in general population exposures via drinking water ingestion, dermal contact, and inhalation from air releases (CPSC ). Available assessments reviewed indicate that diet has been reported the primary source of exposure to DIBP with indoor air also contributing to total DIBP exposure (CPSC 2014). In the United States, urinary DIBP levels have increased over the past four National Health and Nutrition Examination Survey (NHANES) surveys (2001-2002; 2003-2004; 2005-2006; 2007- 2008) in all age groups, genders, and races, and in total (CPSC 2014). 9. Other risk-based criteria that EPA determines to be relevant to the designation of the chemical substance's priority EPA did not identify other risk-based criteria relevant to the designation of the chemical substance's priority. 15 ------- Table 9. Exposure Information for the Environment and General Population Database Name Env. Concen. Data Present? Human Biomon. Data Present? Ecological Biomon. Data Present? Reference California Air Resources Board no no no CARB (2005) Comparative Toxicogenomics Database yes no no MDI (2002) EPA Ambient Monitoring Technology Information Center - Air Toxics Data no no no \(1990) EPA Discharge Monitoring Report Data no no no \ (2007) EPA Unregulated Contaminant Monitoring Rule no no no \ (1996) FDA Total Diet Study no no no FDA (1991) Great Lakes Environmental Database no no no (2018b) Information Platform for Chemical Monitoring Data no no no EC (2018) International Council for the Exploration of the Sea no no no ICES (2018) OECD Monitoring Database no no no OECD (2018) Targeted National Sewage Sludge Survey no no no \ (2006) The National Health and Nutrition Examination Survey no no no CDC (2013) USGS Monitoring Data -National Water Quality Monitoring Council no no no rS(1991a) USGS Monitoring Data -National Water Quality Monitoring Council, Air no no no rS (1991b) USGS Monitoring Data -National Water Quality Monitoring Council, Ground Water no no no rS(1991c) USGS Monitoring Data -National Water Quality Monitoring Council, Sediment no no no S(199Id) USGS Monitoring Data -National Water Quality Monitoring Council, Soil no no no rS(1991e) USGS Monitoring Data -National Water Quality Monitoring Council, Surface Water no no no USGS (199If) USGS Monitoring Data -National Water Quality Monitoring Council, Tissue no no no USGS (1991s) 1 Conccn.= concentration bBiomon.= biomonitoring 16 ------- 10. Proposed designation and Rationale Proposed designation: High-priority substance Rationale: EPA identified and analyzed reasonably available information and concluded that DIBP may present an unreasonable risk of injury to health and/or the environment, including potentially exposed or susceptible subpopulations, (e.g., workers, consumers, women of reproductive age, consumers, children). This is based on the potential hazard and potential exposure of DIBP under the conditions of use described in this document to support the prioritization designation. Specifically, EPA expects that the manufacturing, processing, distribution, use and disposal of DIBP may result in presence of the chemical in surface water, ingestion of the chemical in drinking water, inhalation of the chemical from air releases, exposure to workers, exposure to consumers and exposure to the general population, including exposure to children. In addition, EPA expects potential environmental (e.g., aquatic toxicity, terrestrial toxicity), and human health hazards (e.g., repeated dose toxicity, reproductive toxicity, developmental toxicity). 17 ------- 11. References *Note: All hyperlinked in-text citations are also listed below * Boyd, WA; Smith, MV; Co, CA; Pirone, JR; Rice, JR; Shockley, KR; Freedman, JH. (2016). Developmental effects of the ToxCast Phase I and Phase II Chemicals in Caenorhabditis elegans and corresponding responses in Zebrafish, Rats, and Rabbits. Environ Health Perspect 124: 586- 593. https://www.ncbi.nlm.nih.eov/pmc/articles/PMC4858399/pdf/ehp.1409645.pdf CARB (California Air Resources Board). (2005). California Air Resources Board (CARB): Indoor air pollution in California [Database], Retrieved from https://ww3.arb.ca.gov/research/apr/reports/13Q41.pdf CDC (Centers for Diseases Control and Prevention). (2013). 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