TSCA Work Plan Chemical 

Problem Formulation and Data Needs Assessment 

Brominated Phthalates Cluster 

Flame Retardants 

Br O 

Br

O Alkyl

O 

Br

Br O

Alkyl

CASRN NAME 

26040-51-7 1,2-Benzenedicarboxylic acid, 3,4,5,6-tetrabromo-, 1,2-bis(2-

ethylhexyl) ester 

183658-27-7 Benzoic acid, 2,3,4,5-tetrabromo-, 2-ethylhexyl ester 

20566-35-2 1,2-Benzenedicarboxylic acid, 3,4,5,6-tetrabromo-, 1-[2-(2-

hydroxyethoxy)ethyl] 2-(2-hydroxypropyl) ester 

77098-07-8 1,2-Benzenedicarboxylic acid, 3,4,5,6-tetrabromo-, mixed 

esters with diethylene glycol and propylene glycol 

7415-86-3 1,2-Benzenedicarboxylic acid, 1,2-bis(2,3-dibromopropyl) ester 

* Confidential A 

* Confidential B 

* Confidential Business Information 

August 2015 

United States 

Environmental Protection Agency

EPA Document# 740-Q1-4004 

August 2015 

Office of Chemical Safety and 

Pollution Prevention
 

Page 2 of 52 

TABLE OF CONTENTS 

TABLE OF CONTENTS ............................................................................................................. 2

AUTHORS / CONTRIBUTORS / ACKNOWLEDGEMENTS ............................................................ 4

ABBREVIATIONS .................................................................................................................... 5

EXECUTIVE SUMMARY ........................................................................................................... 7

1 INTRODUCTION .............................................................................................................. 9

1.1 SCOPE OF THE ASSESSMENT .............................................................................................................................. 10

1.1 REGULATORY AND ASSESSMENT HISTORY ............................................................................................................ 13

2 PROBLEM FORMULATION ............................................................................................. 14

2.1 PHYSICAL AND CHEMICAL PROPERTIES ................................................................................................................. 14

2.2 USES ............................................................................................................................................................ 14

2.2.1 Additives ................................................................................................................................................. 15

2.2.2 Reactives................................................................................................................................................. 17

2.2.3 Confidential A and Confidential B ........................................................................................................... 17

2.3 FATE AND TRANSPORT ..................................................................................................................................... 17

2.4 EXPOSURES .................................................................................................................................................... 17

2.4.1 Releases to the Environment .................................................................................................................. 18

2.4.2 Presence in the Environment .................................................................................................................. 19

2.4.3 Occupational Exposures ......................................................................................................................... 19

2.4.4 General Population Exposures ................................................................................................................ 20

2.4.5 Consumer Exposures ............................................................................................................................... 20

2.5 HAZARD ENDPOINTS ........................................................................................................................................ 21

2.5.1 Ecological Hazard ................................................................................................................................... 21

2.5.2 Human Health Hazard ............................................................................................................................ 22

2.6 RESULTS OF PROBLEM FORMULATION ................................................................................................................. 23

2.6.1 Conceptual Model .................................................................................................................................. 23

2.6.2 Analysis Plan ........................................................................................................................................... 24

2.6.3 Sources and Pathways Excluded From Further Assessment ................................................................... 26

2.6.4 Uncertainties and Data Gaps ................................................................................................................. 26

3 DATA NEEDS ASSESSMENT ............................................................................................ 41

3.1 DATA NEEDS CONCLUSIONS – ADDITIVE BROMINATED PHTHALATE CLUSTER (BPC) CHEMICALS .................................... 41

3.2 DATA NEEDS CONCLUSIONS – REACTIVE BROMINATED PHTHALATE CLUSTER (BPC) CHEMICALS .................................... 45

REFERENCES ........................................................................................................................ 47

APPENDICES ........................................................................................................................ 52
 

Page 3 of 52 

LIST OF TABLES 

Table 1-1: Members of the Brominated Phthalates Cluster ......................................................... 10

Table 2-1: Production Volumes of the Brominated Phthalates Cluster Chemicals ...................... 18

Table 3-1: Data Needs Assessment (DNA) .................................................................................... 41

Table 3-2: Data Needs Assessment ............................................................................................... 45

LIST OF APPENDIX TABLES 

Table_Apx A-1: Comparison of Different Polyurethane Foam Products ...................................... 52

LIST OF FIGURES 

Figure 2-1: Conceptual Model for the Brominated Phthalates Cluster ........................................ 23

Figure 2-2: Overview of Data Needs for Hazard and Exposure to Dust during Polyurethane 

Foams (PUF) manufacture and use of PUF Products .................................................................... 27

Figure 2-3: Overview of Data Needs for Ecotoxicity from Environmental Exposure to Brominated 

Phthalates Cluster (BPC) chemicals in Polyurethane Foams (PUF). ............................................. 28

Figure 2-4: Overview of Data Needs for Human Health exposure to dust and TBPH from 

Polyurethane Foams (PUF) ........................................................................................................... 29

Figure 2-5: Overview of Data Needs for Human Health exposure to dust and TBB from 

Polyurethane Foams (PUF) ........................................................................................................... 30

Figure 2-6: Overview of Data Needs for Human Health exposure to dust and Bromo Alkyl Ester 

from Polyurethane Foams (PUF)................................................................................................... 31

Figure 2-7: Overview of Data Needs for Human Health exposure to dust and TBPA-DIOL AND 

TBPA-DIOL (MIXED ESTERS) chemicals from Polyurethane Foams (PUF) .................................... 32
 

Page 4 of 52 

AUTHORS / CONTRIBUTORS / ACKNOWLEDGEMENTS 

This report was developed by the United States Environmental Protection Agency (US EPA), 

Office of Chemical Safety and Pollution Prevention (OCSPP), Office of Pollution Prevention and 

Toxics (OPPT). The Work Plan Data Needs Assessment for the brominated phthalates cluster 

was prepared based on currently available data. Mention of trade names does not constitute 

endorsement by the EPA. 

EPA Assessment Team 

Lead: 

Maria Szilagyi, OPPT/Risk Assessment Division (RAD)

Team Members: 

Robert Boethling, OPPT/RAD 

Christina Cinalli, OPPT/Chemistry, Economics & Sustainable Strategies Division (CESSD) 

Karen Eisenreich, OPPT/RAD 

Greg Fritz, OPPT/CESSD 

Jay Jon, OPPT/RAD 

Timothy Lehman, OPPT/CESSD 

Kendra Moran, OPPT/RAD 

Loraine Passe, OPPT/Chemical Control Division (CCD)

Management Leads: 

Mark Townsend, OPPT/RAD 

Stan Barone Jr., OPPT/RAD 

Acknowledgements 

The following individuals contributed to portions of this document 

H. Kay Austin, OPPT/RAD 

Charles Bevington, OPPT/RAD 

Internal Peer Reviewers 

Mary C. Fehrenbacher, OPPT/RAD 

Nhan Nguyen, OPPT/RAD 

Jennifer Seed, OPPT/RAD 

Yvette Selby-Mohamadu, OPPT/RAD 

Portions of this document and the technical supplements were prepared for EPA/OPPT by Abt 

Associates, the Syracuse Research Corporation (SRC) and Versar. 

Docket 

Please visit the public docket (Docket: EPA-HQ-OPPT-2014-0491) to view supporting 

information. 
 

Page 5 of 52 

ABBREVIATIONS 

BFR Brominated Flame Retardant 

BPC Brominated Phthalates Cluster 

CASRN Chemical Abstract Service Registry Number 

CBI Confidential Business Information 

CDR Chemical Data Reporting 

CPSC Consumer Product Safety Commission 

DEHP bis (2-ethylhexyl) phthalate 

DNA Data Needs Assessment 

EC European Commission 

ECHA European Chemicals Agency 

EPA Environmental Protection Agency 

EU European Union 

FR Flame Retardant 

HPV High Production Volume 

IUR Inventory Update Reporting Rule 

kg Kilogram(s) 

K

OW Octanol:Water partition coefficient 

lb Pound 

LOEL Lowest Observed Effect Level 

Log KOW Logarithmic octanol:water partition coefficient 

mg Milligram 

NICNAS National Industrial Chemicals Notification and Assessment Scheme 

NOAEL No-observed-adverse-effect level 

OCSPP Office of Chemical Safety and Pollution Prevention 

OECD Organisation for Economic Co-operation and Development 

OPPT Office of Pollution Prevention and Toxics 

OSHA Occupational Safety and Health Administration

PBDE Polybrominated Diphenyl Ether 

PentaBDE Pentabrominated diphenyl ether 

PFA Polyurethane Foam Association 

PUF Polyurethane foams (in recognition of the variety of polyurethane foam 

formulations) 

PVC Polyvinylchloride 

REACH Registration, evaluation, authorisation and restriction of chemicals 

SVOCs Semi-volatile organic chemicals 

TBB Benzoic acid, 2, 3, 4, 5-tetrabromo-, 2-ethylhexyl ester 

TBPH 1, 2-Benzenedicarboxylic acid, 3, 4, 5, 6-tetrabromo-, 1, 2-bis (2-ethylhexyl) ester 

TBPA-Diol Generic designator that is used for 1, 2-Benzenedicarboxylic acid, 3, 4, 5, 6-

tetrabromo-, 1-[2-(2-hydroxyethoxy) ethyl] 2-(2-hydroxypropyl) ester 
 

Page 6 of 52 

TBPA-Diol (mixed esters) 

Generic designator that is used for 3,4,5,6 tetrabromo-1, 2-benzene dicarboxylic 

acid, mixed esters with diethylene glycol and propylene glycol 

TCEP Tris (2-chloroethyl) phosphate 

TSCA Toxic Substances Control Act 

US United States 
 

Page 7 of 52 

EXECUTIVE SUMMARY 

As part of EPA’s comprehensive approach to enhance the Agency’s management of existing 

chemicals, EPA/OPPT identified a work plan of chemicals for further assessment under the Toxic 

Substances Control Act (TSCA) in March 2012. Chemical risk assessments will be conducted if, 

as a result of scoping and problem formulation, there are exposures of concern, identified 

hazards and sufficient data for quantitative analysis. If an assessment identifies unreasonable 

risks to humans or the environment, EPA will pursue risk reduction. This document presents the 

data needs assessment for the brominated phthalates cluster as part of the TSCA Work Plan. 

EPA/OPPT has identified a cluster of cyclic aliphatic bromide flame retardant chemicals, 

including 1,2-benzenedicarboxylic acid, 3,4,5,6-tetrabromo-, 1,2-bis(2-ethylhexyl) ester (TBPH; 

CASRN 26040-51-7); benzoic acid, 2,3,4,5-tetrabromo-, 2-ethylhexyl ester (TBB; CASRN 183658-

27-7); 1,2-benzenedicarboxylic acid, 3,4,5,6-tetrabromo-, 1-[2-(2-hydroxyethoxy)ethyl] 2-(2-

hydroxypropyl) ester (TBPA-Diol; CASRN 20566-35-2); 1,2-benzenedicarboxylic acid, 3,4,5,6-

tetrabromo-, mixed esters with diethylene glycol and propylene glycol [TBPA-Diol (mixed 

esters); CASRN 77098-07-8] and 1,2-benzenedicarboxylic acid, 1,2-bis(2,3-dibromopropyl) ester 

(CASRN 7415-86-3). In addition there are two other chemicals in the cluster whose name and 

structure are considered confidential, designated, Confidential A and Confidential B. These 

chemicals have similar physical and chemical properties and environmental fate characteristics 

two of these chemicals, TBPH and TBB1

 have been selected as the index chemicals for this

cluster. Uses for 1,2-benzenedicarboxylic acid, 1,2-bis(2,3-dibromopropyl) ester (CASRN 7415-

86-3) have not been identified: the remaining identified members of the cluster are used as 

flame retardants in polyurethane foams (PUF). The toxicological hazard profile for this cluster of 

chemicals is incomplete. 

The conclusions from Problem Formulation, as illustrated in the Conceptual Model and 

described by Assessment Questions, indicate that the toxicological profile and exposure profile 

for this cluster of chemicals is incomplete and inadequate to develop a TSCA work plan risk 

assessment. EPA/OPPT found that while the data for Firemaster®BZ-54 are sufficient to support 

a determination that TBB may present an unreasonable risk in certain scenarios, this review 

identified critical data gaps and uncertainties related to exposure and hazard which preclude 

EPA/OPPT from moving forward with an assessment for any of the chemicals in the Brominated 

Phthalates Cluster. 

During problem formulation, EPA/OPPT identified available fate, exposure and hazard data, and 

characterized potential exposures, receptors and effects. Data adequacy were determined 

following published EPA/OPPT criteria2

. EPA/OPPT reviewed the public literature (nominally to 

 

1 TBPH and TBB have been identified as components for Firemaster®550 and Firemaster®BZ-54 for which data are 

being generated in the open literature 

2

 Generally followed guidance outlined for the High Production Volume Challenge Program at: 

http://www.epa.gov/chemrtk/pubs/general/datadfin.htm and 

http://www.epa.gov/champ/pubs/hpv/Methodology%20for%20HBP%20under%20ChAMP_March%202009.pdf

And EPA Risk Assessment Guidance at: http://www.epa.gov/raf/
 

Page 8 of 52 

August 2013) and its own files (public and confidential) to explore the sources, pathways, 

receptors and effects for consideration in the assessment and identified areas of data 

limitation, data uncertainty and critical missing data elements necessary to conduct the 

assessment. EPA/OPPT developed a conceptual model and an analysis plan as a result of 

problem formulation. 

Likely sources and pathways considered for analysis include use of BPC members as flame 

retardants in polyurethane foams (PUF) and PUF products found in commercial and residential 

environments. Monitoring studies have reported the occurrence of TBPH and TBB in various 

media including sludge, sediment, indoor dust and biota. Frequent detection of TBPH and TBB

in these media provides evidence of release and transport of TBPH and TBB into the 

environment and suggests an increasing potential for exposure. Some data show exposures to 

TBPH and TBB to remote species (e.g. seals and sea birds) indicating the occurrence of global 

release and transport. The source of the chemicals is unknown. There is no evidence of 

environmental exposure to the other BPC members reported in the literature. No information 

on potential worker exposure or release to the environment during BPC chemical manufacture, 

PUF manufacture or PUF processing is available. However, monitoring data suggest that worker 

exposure to BPC chemicals during the use of PUF containing products occurs. 

EPA/OPPT developed a conceptual model to outline the assessment strategy for the PBC 

chemicals. Using available tools and approaches, EPA/OPPT identified the relevant TSCA use of 

TBPH and TBB as flame retardants in PUF and PUF products found in residential and 

commercial environments. EPA/OPPT determined that the major source of exposure to TBPH

and TBB for human health and the environment was via TBPH and TBB in dust and/or TBPH and 

TBB in dust generated during the manufacture and processing of TBPH and TBB and the 

processing and use of products containing TBPH and TBB. TBPH and TBB have been detected in 

house dust. In addition, there is evidence that a diverse array of commercial and household 

PUF-containing articles containing TPBH and TBB can be broken down (i.e. via mechanical or 

physical wearing, or chemical degradation), thus contributing to dust/microplastic particles. 

During routine cleaning operations, it is thought that these microparticles derived from PUF and 

PUF products can be washed away into the sewerage systems where these particles containing 

BPC chemicals can adhere to wastewater treatment plant sludge or make their way into the 

outdoor environment by transportation through the air and/or washed down the drains (or 

storm drains) to enter waterways. 

Due to the prevalence of PUF and PUF products in commercial and residential settings, 

EPA/OPPT focused the exposure scenarios on PUF manufacture and use of PUF products, and 

the use of PUF and PUF products by workers and consumers in commercial and residential 

environments. The monitoring of TBPH and TBB in dust is considered a good indicator for the 

evaluation of human exposure to PUF and PUF-containing products. 

As a result of this problem formulation, EPA/OPPT is releasing a Data Needs Assessment for the 

Brominated Phthalates Cluster to guide the collection of additional data and information to fill 

the critical data gaps and reduce uncertainties identified during problem formulation. As the 
 

Page 9 of 52 

information is collected, EPA will continue to evaluate the adequacy of the database to conduct 

a risk assessment that can inform decision making. 

1 INTRODUCTION 

As a part of EPA’s comprehensive approach to enhance the Agency’s management of existing 

chemicals, in March 2012 EPA identified a work plan of chemicals for further assessment under 

the Toxic Substances Control Act (TSCA)3. After gathering input from stakeholders, EPA 

developed criteria used for identifying chemicals for further assessment4. The criteria focused 

on chemicals that meet one or more of the following factors: (1) potentially of concern to 

children’s health (for example, because of reproductive or developmental effects); (2) 

neurotoxic effects; (3) persistent, bioaccumulative, and toxic (PBT); (3) probable or known 

carcinogens; (4) used in children’s products; or (5) detected in biomonitoring programs. Using 

this methodology, EPA/OPPT identified a TSCA Work Plan of chemicals as candidates for risk 

assessment in the next several years. In the prioritization process, the brominated phthalates 

cluster (BPC), was identified for assessment based on available data for the two index chemicals 

TBPH and TBB. The cluster members are expected to be persistent, bioaccumulative and 

potentially hazardous to human health (developmental toxicity) and the environment (acute 

and chronic toxicity). 

EPA/OPPT is performing risk assessments on chemicals in the work plan. If an assessment 

identifies unacceptable risks to humans or the environment, EPA/OPPT will pursue risk 

management. The target audience for this risk assessment is primarily EPA risk managers; 

however, it may also be of interest to the broader risk assessment community as well as US 

stakeholders interested in the brominated phthalates cluster. The information presented in the 

risk assessment may be of assistance to other federal, state and local agencies as well as to 

members of the general public who are interested in the risks of the brominated phthalates 

cluster. 

The initial steps in EPA/OPPT’s risk assessment development process, which is distinct from the 

initial prioritization exercise, includes scoping and problem formulation. During these steps 

EPA/OPPT reviews currently available data and information, including but not limited to, 

assessments conducted by others (e.g., authorities in other countries), published or readily 

available reports and published scientific literature. During scoping and problem formulation 

the more robust review of the factors influencing initial prioritization may result in refinement – 

either addition/expansion or removal/contraction – of specific hazard or exposure concerns 

previously identified in the prioritization methodology. 

This document includes the results of scoping and problem formulation for the brominated 

phthalates cluster. In the initial prioritization and scoping stages EPA/OPPT determined which 

 

3 http://www.epa.gov/oppt/existingchemicals/pubs/workplans.html 

4 http://www.epa.gov/oppt/existingchemicals/pubs/wpmethods.pdf
 

Page 10 of 52 

chemical(s) would be included and what uses would be considered in the assessment. During 

problem formulation, EPA/OPPT identified available exposure and hazard data, and 

characterized potential exposures, receptors and effects. EPA/OPPT developed a conceptual 

model (Section 2.6.1) and analysis plan (Section 2.6.2) as a result of problem formulation. 

1.1 Scope of the Assessment 

The members of the Brominated Phthalates Cluster (BPC) are depicted in Table 1-1. 

Confidential A and Confidential B are referenced throughout the assessment and where 

appropriate, information that is not deemed confidential is included or cited as Confidential 

Business Information (CBI). The BPC chemicals have several structural features in common: 

multiple bromine atoms, typically attached to the aromatic ring; t he 1, 2-benzenedicarboxylate 

moiety (phthalate structure)5 and they are alkyl esters. These common features form the basis 

of these chemicals being clustered and assessed together. In addition, the overarching use of 

these chemicals is as flame retardants (FR) in a variety of products with polyurethane foams 

(PUF) being the major use and focus of this assessment. 

Table 1-1: Members of the Brominated Phthalates Cluster 

CASRN NAME STRUCTURE 

26040-51-7 TBPH: 1,2-

Benzenedicarboxylic acid, 

3,4,5,6-tetrabromo-, 1,2-

bis(2-ethylhexyl) ester

183658-27-7 TBB: Benzoic acid, 2,3,4,5-

tetrabromo-, 2-ethylhexyl 

ester

20566-35-2 TBPA-Diol: 1,2-

Benzenedicarboxylic acid, 

3,4,5,6-tetrabromo-, 1-[2-

(2-hydroxyethoxy)ethyl] 2-

(2-hydroxypropyl) ester 

 

5 The cluster member 2-ethylhexyl tetrabromobenzoate (TBB), CASRN [183658-27-7] is missing one of the 

phthalate carboxylate esters but is included in this cluster since the commercial product Firemaster®550 also 

contains the TBB / TBPH phthalate mixture. This structural anomaly should not affect the inclusion of this 

chemical since phthalates often decarboxylate during metabolism and biodegradation. (Kleerebezem, 1999)
 

Page 11 of 52 

CASRN NAME STRUCTURE 

77098-07-8 TBPA Diol (mixed esters): 

3,4,5,6 tetrabromo-1,2-

benzene dicarboxylic acid, 

mixed esters with 

diethylene glycol and 

propylene glycol

Representative Structure 

7415-86-3 Bromo Alkyl Ester: 1,2-

Benzenedicarboxylic acid, 

1,2-bis(2,3-dibromopropyl) 

ester

CONFIDENTIAL A * * 

CONFIDENTIAL B * * 

*Confidential Business Information 

1,2-Benzenedicarboxylic acid, 3,4,5,6-tetrabromo-, 1,2-bis(2-ethylhexyl) ester (TBPH; CASRN 

26040-51-7) and benzoic acid, 2,3,4,5-tetrabromo-, 2-ethylhexyl ester (TBB; CASRN 183658-27-

7) are used as additives in product formulations (e.g. Firemaster®550). 1, 2-Benzenedicarboxylic 

acid, 1, 2-bis (2, 3-dibromopropyl) ester (Bromo Alkyl Ester; CASRN 7415-86-3) is also used as 

an additive but hasn’t been introduced into commerce in quantities that trigger reporting under 

IUR/CDR (Inventory Update Reporting/Chemical Data Reporting). 1,2-Benzenedicarboxylic acid, 

3,4,5,6-tetrabromo-, 1-[2-(2-hydroxyethoxy)ethyl] 2-(2-hydroxypropyl) ester (TBPA-Diol; CASRN 

20566-35-2) and 1,2-Benzenedicarboxylic acid, 3,4,5,6-tetrabromo-, mixed esters with 

diethylene glycol and propylene glycol [TBPA-Diol (mixed esters); CASRN 77098-07-8] are 

primarily used as reactives in product formulations and are incorporated into the polyurethane 

backbone via a covalent bond. Only one of the two confidential cluster members was reported 

in CDR. The stated use was claimed as CBI. 

All chemicals in the cluster are listed on the TSCA Inventory. All chemicals, except for Bromo 

Alkyl Ester (CASRN 7415-86-3) and Confidential A, are all found in commerce at volumes 

greater than one million pounds. The exact production volume of TBB and Confidential B are 

considered CBI and the information cannot be shared publicly. 

Monitoring data show that 1,2-benzenedicarboxylic acid, 3,4,5,6-tetrabromo-, 1,2-bis(2-

ethylhexyl) ester (TBPH) and benzoic acid, 2,3,4,5-tetrabromo-, 2-ethylhexyl ester (TBB) are 

present not only in environments where chemicals are expected (homes, aircrafts, cars and 

office buildings), but also in environments where anthropogenic chemicals are not expected 
 

Page 12 of 52 

(natural environment and wildlife) raising concerns about exposure to these chemicals. 

Furthermore, the TBPH/TBB ratio found in the environment is different from that found in the 

manufactured commercial product (Davis et al., 2012; Stapleton et al., 2008a). No evidence of 

environmental exposure to the other brominated phthalate cluster (BPC) members has been 

found. 

Using available tools and approaches, EPA/OPPT identified the relevant TSCA use of TBPH and 

TBB as flame retardants in PUF and PUF products found in residential and commercial 

environments. EPA/OPPT determined that the major source of exposure to TBPH and TBB for 

human health and the environment was via TBPH and TBB in dust and/or TBPH and TBB in dust 

generated during the manufacture and processing of TBPH and TBB and the processing and use 

of products containing TBPH and TBB. TBPH and TBB have been detected in house dust. In 

addition, there is evidence that a diverse array of commercial and household PUF-containing 

articles containing TPBH and TBB can be broken down (i.e. via mechanical or physical wearing, 

or chemical degradation), thus contributing to dust/microplastic particles. During routine 

cleaning operations, it is thought that these microparticles derived from PUF and PUF products 

can be washed away into the sewerage systems where these particles containing BPC chemicals 

can adhere to wastewater treatment plant sludge or make their way into the outdoor 

environment by transportation through the air and/or washed down the drains (or storm 

drains) to enter waterways. 

Due to the prevalence of PUF and PUF products in commercial and residential settings, 

EPA/OPPT focused the exposure scenarios on PUF manufacture and use of PUF products, and 

the use of PUF and PUF products by workers and consumers in commercial and residential 

environments. The monitoring of TBPH and TBB in dust is considered a good indicator for the 

evaluation of human exposure to PUF and PUF-containing products. 

TBPH and TBB have been detected in dust samples in commercial and domestic indoor 

environments suggesting that the monitoring of TBPH and TBB in dust is considered a good 

model for the evaluation of human exposure to PUF and PUF containing products. The source 

of TBPH and TBB in the outdoor environment is not known and so potential releases to the 

environment from PUF manufacturing and processing are also being assessed. PBDE research 

for foam products as a source of FR has been well documented and is the basis of EPA/OPPT’s 

current focus on the BPC chemicals in dust and specifically PUF. Hale demonstrated that FRtreated polyurethane foams were a source of PBDE exposure up the food chain (Hale et al., 

2002). In addition, TBPH/TBB were shown to increase in air samples as the market switched 

from PBDE to BPC in foam (Ma et al., 2012). FR [TCEP] concentrations in dust were directly 

associated with FR content in foam baby products as opposed to other FR containing products 

(Marklund et al., 2005). 

EPA/OPPT found limited hazard data for assessing the human health and environmental effects 

endpoints. In addition, only limited data are available for the commercial products (e.g. 

Firemaster®550 and Firemaster®BZ-54) which show potential toxicity to human health and the 

environment and whose effects are difficult to attribute to a particular BPC chemical without 
 

Page 13 of 52 

additional information. Further, data on the commercial products from non-guideline studies 

indicate that toxicity observed for phthalates alone may not be the same for the structurally 

similar brominated phthalates. Available data from environmental studies were not considered 

reliable as these provided conflicting results. Consequently, EPA/OPPT determined that the 

available data for the BPC index chemicals, TBPH and TBB, are inadequate to characterize 

hazard or exposure for the purposes of risk assessment. 

1.1 Regulatory and Assessment History 

All chemicals in the cluster are listed on the TSCA Inventory. All chemicals, except for Bromo 

Alkyl Ester (CASRN 7415-86-3) and Confidential A, are all found in commerce at volumes 

greater than one million pounds. The exact production volume of TBB and Confidential B are 

considered CBI and the information cannot be shared publicly. 

EPA/OPPT reviewed the public literature (nominally to August 2013) and its own files (public 

and confidential) in the preparation of this assessment. Data adequacy was determined 

following published EPA/OPPT criteria6

. Internationally, TBPH has been registered for use in the 

European Union (EU) and Canada is gathering information for preparing a screening-level 

assessment. Canada is also gathering information on TBB. Bromo Alkyl Ester (CASRN 7415-86-

3) has been cited in the World Health Organisation’s (WHO) programme for chemical safety 

(WHO, 1997). TBPA-Diol has also been registered in the EU and is cited in the WHO programme 

for chemical safety (WHO, 1997). In Australia, the National Industrial Chemicals Notification and 

Assessment Scheme (NICNAS) prepared a report on the polybrominated flame retardants which 

references TBPA-Diol and TBPA-Diol (mixed esters). No hazard data were available for human 

health or ecotoxicity for these two chemicals (NICNAS, 2001). Hazard data have since been 

published for the commercial product, Firemaster®BZ-54 (Chemtura, 2012a; NICNAS, 2004), 

which is a mixture of TBPH and TBB (Chemtura, 2010). 

In the US, the Consumer Product Safety Commission (CPSC) has published two risk assessments 

on the use of flame retardants: a preliminary risk assessment of FR chemicals in upholstered 

furniture foam (CPSC, 2006a) and a quantitative assessment of potential health effects from the 

use of fire retardant chemicals in mattresses (CPSC, 2006b). Firemaster®550 was included in 

this assessment; however, the associated BPC chemicals (TBPH and TBB) were not assessed due 

to the lack of toxicity data. 

Screening-level data for two of the BPC chemicals [TBPH and TBPA-Diol (mixed esters)] were 

submitted to EPA/OPPT under the High Production Volume (HPV) Challenge Program (ACC, 

2004; Albemarle - GLCC, 2004). In 2003, EPA/OPPT’s Design for the Environment (DfE) program 

convened a multi-stakeholder group to undertake an assessment of viable alternatives to 

 

6

 Generally followed guidance outlined for the High Production Volume Challenge Program at: 

http://www.epa.gov/chemrtk/pubs/general/datadfin.htm and 

http://www.epa.gov/champ/pubs/hpv/Methodology%20for%20HBP%20under%20ChAMP_March%202009.pdf

and EPA Risk Assessment Guidance at: http://www.epa.gov/raf/
 

Page 14 of 52 

pentaBDE called the Furniture Flame Retardancy Partnership (FFRP), which included chemical 

manufacturers, furniture manufacturers, and governmental and non-governmental 

organizations. At the end of 2004, industry voluntarily ceased production of pentaBDE, and 

EPA/OPPT issued a Significant New Use Rule (SNUR) that effectively prohibited further 

manufacture of the chemical. In 2005, the partnership issued the report, "Environmental 

Profiles of Chemical Flame-Retardant Alternatives for Low-Density Polyurethane Foam (EPA, 

2005). The report described the human health and environmental profiles of twelve pentaBDE 

alternatives which did not appear to pose the same level of concern as pentaBDE. DfE recently 

announced the development of an update to the Alternative Assessment for flame retardants 

in furniture foam (http://www.epa.gov/dfe/pubs/projects/flameret/about.htm). For the 

update, DfE identified nineteen flame retardants and blends relevant to the market in 2013 that 

may be used in upholstered consumer product containing flexible polyurethane foam. The 

report included an assessment of TBPH and TBB based on the available science at the time; the 

update will include revised profiles for these two substances and be complementary to this 

data needs assessment. In addition, data are available for the commercial product, Firemaster® 

BZ -54 (Chemtura, 2012a; NICNAS, 2001) which is a mixture of TBPH and TBB (Chemtura, 2010). 

2 PROBLEM FORMULATION 

The problem formulation stage is intended to determine the major factors to be considered in 

the assessment, including exposure pathways, receptors and health endpoints (EPA, 1998, 

2014). Accordingly, this problem formulation summarized the exposure pathways, receptors 

and health endpoints EPA/OPPT has recommended for inclusion in the risk assessment. To 

make this determination, EPA/OPPT conducted a preliminary data review, to identify available 

fate, exposure and hazard data and determine its likely suitability for quantitative analysis and 

to identify exposure pathways, receptors and health endpoints for quantitative analysis. 

EPA/OPPT summarized the outcome of this evaluation in conceptual models that illustrate the 

exposure pathways, receptor populations and effects that will be considered in the risk 

assessment. EPA/OPPT also prepared data analysis plans to demonstrate the proposed 

approach to answering the defined assessment questions. 

2.1 Physical and Chemical Properties 

The physical and chemical properties are summarized in the technical supplement [EPA# 740-

Q1-4001] titled “Physicochemical properties and environmental fate of the brominated 

phthalates cluster (BPC) chemicals” which can be found at Docket Number EPA-HQ-OPPT-2014-

0491 on www.regulations.gov. 

2.2 Uses 

EPA/OPPT has prepared a data needs assessment (DNA) to facilitate the gathering of 

appropriate data needed to prepare a risk assessment of the BPC chemicals. To refine the scope 

of the DNA, use scenarios were evaluated and are summarized in the supporting document 
 

Page 15 of 52 

(EPA# 740-Q1-4004 on www.regulations.gov). The major use identified for all cluster members

is as a flame retardant (FR) in polyurethane foams (PUF) and PUF products. The other uses 

identified are considered minor in comparison to the amount of chemical used in PUF. 

Therefore, the manufacture of the brominated phthalates cluster members for use in PUF and 

PUF products is the focus of this assessment. As stated above, BPC use in PUF is a potential 

source of FR but EPA/OPPT’s focus on dust will capture use in PUF products even if they cannot 

be directly correlated to the specific source. In addition, under the Commission for 

Environmental Cooperation (CEC), Canada, Mexico and the United States are evaluating the 

presence and migration of flame retardants, including members of the BPC, from consumer 

products. The information gathered from this effort will inform future risk assessment. 

EPA/OPPT distinguishes the BPC flame retardants as either reactive or additive depending on 

whether or not the BPC chemical reacts with the isocyanate monomers to become 

incorporated into the polymer backbone via covalent bond formation. The BPC chemicals 

containing free hydroxy moieties chemically react with the isocyanate groups to make the 

polyurethane linkages. This process can be utilized to make both rigid and flexible PUF. 

However, the literature suggests that the reactive BPCs are more commonly used for rigid foam 

[(Dufton PF, 1998), US Patent 5637797 and US Patent application 20120238657]. They do not 

discount the use in flexible PUF products and suggest that the reactive BPC chemical may also 

be used in other products as an additive brominated flame retardant (BFR). These patents also 

suggest that additive BFR, like TBPH/TBB, or excess unreacted reactive BFR, are needed to 

make certain rigid foam applications meet certain safety requirements. In addition, both 

reactive and additive BPC BFR are patented for use with spray polyurethane foam applications 

(WO 2013003261 patent application). 

According to the Polyurethane Foam Association (PFA) literature, Penta BDE was the BFR of 

choice for most all flexible PUF. The BPC chemicals were used as penta alternatives in the 

various flexible PUF products and alternatives to use of any brominated combustion modifying 

additive (CMA). Two statements by PFA reflect the uncertainly of making general statements, 

"... there is no "standard foam" which represents the performance of the flexible polyurethane 

foam (FPF) product category..." and "... there is no such thing as a "standard or real fire" by 

which performance of a material can be measured and projected to represent performance 

under all conditions." While PFA members do not make rigid foam, PFA did publish a 

comparison of the different foam products in 2011 (See Table_Apx A-1). 

The report describes the cluster members in terms of their application in PUF and PUFcontaining products as either additives or reactives. 

2.2.1 Additives 

These chemicals are added to the flexible polyurethane foams (PUF) formulation to function as 

flame retardants. It is anticipated, based on available monitoring data that they are migrating 

through the foam and being released from the foam into the surrounding environment.
 

Page 16 of 52 

2.2.1.1 TBPH and TBB 

1,2-Benzenedicarboxylic acid, 3,4,5,6-tetrabromo-, 1,2-bis(2-ethylhexyl) ester (TBPH) and 

benzoic acid, 2,3,4,5-tetrabromo-, 2-ethylhexyl ester (TBB) are described together because they 

are the major components of the Firemaster® brand of flame retardants (e.g. Firemaster®550

and Firemaster® BZ 54). They are used as additives, primarily in the production of polyurethane 

(PU) foam for use in furniture (flexible to rigid foam). Recycled foam products are not 

addressed specifically because they are comprised of the universe of foam which makes it 

difficult to identify the composition of the recycled foam or the source of the bromine present. 

However, carpet is considered a sink for indoor dust which may be a source of flame retardants 

(and other contaminants) indoors for release during future use (Batterman et al., 2009; 

Muenhor and Harrad, 2012). Therefore, because this assessment addresses exposure to flame 

retardants in dust, use of BPC chemicals in recycled PUF products would be captured in the 

assessment. 

No textile uses have been identified for TBPH/TBB; however, TBPH/TBB were detected 

downstream from a textile manufacturing outfall to a municipal wastewater treatment plant 

(La Guardia et al., 2012). Because there are several foam manufacturing facilities (known 

sources of TBPH/TBB) in this area, it is uncertain that the TBPH/TBB detected in the stream can 

be attributed to the textile sector. 

The use of flame retardants and brominated phthalates in plastic [e.g. polyvinyl chloride (PVC)] 

casings for electronics (e.g. cell phones, computers) or household items (e.g. shower curtains) is 

either being phased out (Greenpeace, 2013) or considered to be released through the use of 

the items. In addition, TBPH has been used in PVC for decades without detection in the 

environment. It is only since its use with TBB in the Firemaster formulations in PU foams that it

has been detected in the environment. Based on its low vapor pressure, it is anticipated that 

TBPH exposure would be through the incidental ingestion of inhaled particulates rather than by 

the inhalation of the pure substance. 

Information on the use of TBPH/TBB in sealants/adhesives is scarce and the use of flame 

retardant in these products is only a small amount of the overall market. There is no 

information on the release of the flame retardant from these products. If released over time 

due to wear and tear, it is likely that the chemical would be captured in the particulate matter 

and detected in dust, e.g. house dust. 

TBPH is also used as a plasticizing flame retardant for flexible polyvinyl chloride (PVC) (CECBP 

SGP, 2008) and as a flame retardant additive for ethylene propylene diene monomer (EPDM) 

M-class rubber, styrene-butadiene rubber (SBR), and neoprene (Chemtura, 2007a, 2007b, 

2007c; Unitex, 2009). Applications of TBPH as a flame retardant plasticizer are adhesives and

coatings; carpet backing; coated fabrics; film and sheeting; wall coverings; and wire and cable 

(CECBP SGP, 2008). Generally, hard plastics contain ‘reactive’, rather than ‘additive’ 

brominated phthalates. 
 

Page 17 of 52 

2.2.1.2 1, 2-Benzenedicarboxylic acid, 1, 2-bis(2, 3-dibromopropyl) ester 

(CASRN 7415-86-3) 

Bromo Alkyl Ester (CASRN 7415-86-3) was identified as potentially used as a flame retardant in 

polyester fibers [textiles; (WHO, 1997)]; however, no uses have been identified for this cluster 

member to date. 

2.2.2 Reactives 

These chemicals are reacted into the polymer backbone of rigid polyurethane foams (PUF). 

Based on available data (nature of chemical reactivity and no detection in the environment), it 

is not anticipated that these chemicals are released from the PUF or PUF product. While they 

can be used as additives, information pertaining to this use is limited (Login et al., 1981) and 

available data suggest that the predominant use is as a reactive substance. 

2.2.2.1 CASRNs 20566-35-2 and 77098-07-8 

1,2-Benzenedicarboxylic acid, 3,4,5,6-tetrabromo-, 1-[2-(2-hydroxyethoxy)ethyl] 2-(2-

hydroxypropyl) ester (TBPA-Diol; CASRN 20566-35-2) and 1,2-benzenedicarboxylic acid, 3,4,5,6-

tetrabromo-, mixed esters with diethylene glycol and propylene glycol [TBPA-Diol (mixed 

esters); CASRN 77098-07-8] are reacted into the polyurethane (PU) foam backbone for 

insulation use. They are typically used in rigid PU foams. Because the major use of this 

insulation is in appliances, such as refrigerators, it is anticipated that the release of the flame 

retardants is limited. However, there are no data to support this. 

2.2.3 Confidential A and Confidential B 

The uses for Confidential A and Confidential B are considered confidential business information. 

2.3 Fate and Transport 

The fate and transport of the BPC chemicals is summarized in the technical supplement [EPA# 

740-Q1-4001] titled “Physicochemical properties and environmental fate of the brominated 

phthalates cluster (BPC) chemicals” which can be found at Docket Number EPA-HQ-OPPT-2014-

0491 on www.regulations.gov. 

2.4 Exposures 

The exposure pathways and associated data for the BPC chemicals are summarized in the 

technical supplement [EPA# 740-Q1-4002] titled “Use and exposure of the brominated 

phthalates cluster (BPC) chemicals” which can be found at Docket Number EPA-HQ-OPPT-2014-

0491 on www.regulations.gov. 
 

Page 18 of 52 

2.4.1 Releases to the Environment 

Production volumes of the BPC chemicals are summarized in Table 2-1. Available data suggest 

that TBPH/TBB are getting into the environment (Stapleton et al., 2008a) (Lam et al., 2009) (La 

Guardia et al., 2012) and being globally transported in the atmosphere (Ma et al., 2012). 

However, the attribution of the chemicals in the environment to any particular source is 

unclear. There is no evidence to suggest that release of BPC members from landfills occurs or 

that they are present in leachate under normal conditions. Some landfills now use incinerators 

where, at the normal functioning incineration temperatures (> 1000 C), it is anticipated that the 

TBPH/TBB will be completely destroyed and will not enter the environment (EPA-HQ-OPPT2003-0071-0004). 

There is no evidence to suggest that the debromination of the BPC chemicals occurs in vivo. 

However, under laboratory conditions, there is evidence to suggest that debromination can 

occur (Davis and Stapleton, 2009; Ronen and Abeliovich, 2000) suggesting that under 

photolytic or anaerobic conditions, the phthalate, namely bis (2-ethylhexyl) phthalate (DEHP), 

can be released. The EPA/OPPT action plan for phthalates outlines the environmental effects of 

DEHP including adverse effects to aquatic organisms with a broad range of endpoints and at 

concentrations that coincide with measured environmental concentrations (EPA, 2012d). 

TBPH and TBPA-diol (mixed esters) are High Production Volume (HPV; produced or imported 

into the US at volumes ≥ one million pounds) chemicals. Information for the other cluster 

chemicals is considered confidential. The release of TBB to water from manufacturing and 

processing is regulated by EPA/OPPT (40 CFR Section 721.2925). 

Table 2-1: Production Volumes of the Brominated Phthalates Cluster Chemicals 

Cluster Member Reporting 

TBPH: CASRN 26040-51-7 2006 IUR PV ≥ 10 million pounds 

2012 CDR PV = 1 to 10 million pounds 

Not on TRI 

TBB: CASRN 183658-27-7 2006 IUR CDR National PV information for the 

chemical withheld. 

2012 CDR National PV information for the chemical 

withheld. 

Not on TRI 

TBPA-Diol: CASRN 20566-35-2 2006 IUR PV = no record 

2012 CDR PV = 1 to 10 million pounds 

Not on TRI 

TBPA-Diol (mixed esters): CASRN 

77098-07-8 

2006 IUR PV = 1 to 10 million pounds 

2012 CDR National PV information for the chemical 

withheld. 

Not on TRI 
 

Page 19 of 52 

Cluster Member Reporting 

Bromo Alkyl Ester: CASRN 7415-86-3 2006 IUR PV = no record 

2012 CDR = no record 

Not on TRI 

Confidential A Consent Order – testing PV not triggered 

Confidential B 2012 CDR National PV information for the chemical 

withheld. 

IUR = Inventory Update Reporting; CDR = Chemical Update Reporting; PV = production volume; TRI = Toxic 

Releases Inventory

2.4.2 Presence in the Environment 

Available data suggest that TBPH/TBB are getting into the environment (Stapleton et al., 2008a) 

(Lam et al., 2009) (La Guardia et al., 2012) and being globally transported in the atmosphere 

(Ma et al., 2012). However, the attribution of the chemicals in the environment to any 

particular source is unclear. 

2.4.3 Occupational Exposures 

EPA/OPPT considers inhalation and dermal exposure to be important exposure pathways for 

workers. Sometimes, the inhalation of air-suspended particulate matter that is subsequently 

trapped in mucous and moved from the respiratory system to the gastrointestinal tract (EPA, 

2011) is a contributor to aggregate exposures. This will be referred to here as incidental 

ingestion of inhaled particulates. 

The Occupational Safety and Health Administration (OSHA) is responsible for the oversight of 

various workplace exposures to workers in the chemical manufacture and production of foam 

(https://www.osha.gov/). At this time, there are no specific standards for workers involved in 

the production of the cluster members or their use in products. 

Generally, during chemical manufacture, occupational exposure via the dermal and inhalation 

routes is likely for many chemicals. However, the cluster members are liquid and have low 

vapor pressures (<1X10-6 mm Hg) suggesting that exposure to vapors via the inhalation route is 

not a cause for concern. 

During polyurethane foams (PUF) (flexible to rigid) processing, there is some concern for foam 

handlers and the particulate matter generated during, for example, cutting and sizing foam for 

use in foam products. The OSHA Permissible Exposure Limit (PEL) for particulates not otherwise 

regulated (general industry) is 15 mg/m3

 TWA (time weighted average) [29 CFR 1910.1000 

Table Z-1 (PNOR) and 29 CFR 1910.1000 Table Z-3 (Inert or Nuisance Dust)]. The American 

Conference of Governmental Industrial Hygienists (ACGIH) Guideline is 10 mg/m3 TWA 

(inhalable particles). 
 

Page 20 of 52 

There is limited data on the use of BPC chemicals in spray foam insulation. Spray polyurethane 

foam consists of two liquid chemical components, referred to as "Side A" and "Side B," that are 

mixed at the site of installation. Side A is mostly made up of isocyanates, while Side B usually 

contains polyol, flame retardants and amine catalysts (Badore, 2013). While most spray foam 

insulation formulations contain chlorinated flame retardants (Babrauskas et al., 2012) evidence 

from patent applications suggests that there is potential use of reactive BPC cluster members 

for this application (WIPO Patent Application WO/2013/003261). 

In addition, there is evidence to suggest that occupational exposures to some sub-populations 

may lead to elevated levels of BPC member chemicals. Studies measuring polybrominated 

diphenyl ether (PBDE) congeners in carpet installers (serum concentrations) (Stapleton et al., 

2008b) and flight attendants (air sampling) (Allen et al., 2013b) show that they are potentially 

exposed to higher levels of PBDEs when compared to the general population. The trend of 

TBPH/TBB substituting for PBDEs would likewise potentially lead to similar elevated exposures 

in these worker environments. In addition, there are data (Carignan et al., 2013) for gymnasts 

that demonstrate exposure to TBPH/TBB; however, the source of exposure is not clear. Gyms 

typically have foam pits which are a known source of TBPH/TBB (Carignan et al., 2013) and are 

a potential source of exposure not only to gymnasts but other subpopulations (e.g. toddlers 

and children) using the gym or other environments (e.g. motocross or skateboarding) 

containing foam pits (http://www.foamorder.com/foam-pit.html). 

2.4.4 General Population Exposures 

There is potential for the general population to be exposed to the brominated phthalates 

cluster (BPC) chemicals through the ingestion of potentially contaminated wildlife and 

vegetation. Available physical-chemical properties of the BPC chemicals suggest that they have 

limited solubility in water and low volatility. Therefore, for the general population and 

consumers, inhalation of volatile BPC chemicals is not anticipated to be a source of significant 

exposure. However, the BPC chemicals do partition into particulate matter (Weschler and 

Nazaroff, 2008, 2010) which is a potential source of exposure via incidental ingestion of inhaled 

particulates. Dermal exposure is not considered a significant route of exposure from BPC 

chemicals from polyurethane foams (PUF) products (Chemtura, 2012a). 

2.4.5 Consumer Exposures 

Consumer exposure to the BPC chemicals may include dermal exposure through direct skin 

contact with the chemicals on the surface of objects or articles, incidental ingestion of inhaled 

particulates (see 2.4.3) and incidental ingestion of indoor settled dust via hand-to-mouth 

behaviors. In addition, children may experience incidental ingestion via object-to-mouth 

behaviors. Inhalation exposure is not expected (see 2.4.4). 

TBPH and TBB have been found in house dust in Boston, MA and California (Stapleton et al., 

2008a) (Dodson et al., 2012). The source of these flame retardants is unclear but could be 

attributed to the number of flame-retardant-containing consumer goods found in homes. 
 

Page 21 of 52 

Flexible polyurethane foam is used in both commercial and domestic furniture. Additional 

information on use in furniture can be found in the EPA/OPPT environmental profile of 

chemical flame-retardant alternatives for low-density PUF (EPA, 2005). TBPH and TBB are semivolatile organic chemicals (SVOCs) with high log-KOA values. Hence, any breakdown of the 

consumer products in situ may lead to the release of the flame retardant which predominantly 

partitions into particulate matter e.g. house dust (Weschler and Nazaroff, 2008, 2010). Carpet 

in homes is considered a natural sink for house dust (Batterman et al., 2009; Muenhor and 

Harrad, 2012). 

EPA/OPPT recognizes that FR have been associated with use in polyvinylchloride (PVC) which is 

present in many consumer goods (e.g. children’s toys, shower curtains, etc.). In addition, TBPH

use was reported in the EPA/OPPT IUR data for decades before the Firemaster®550 or 

Firemaster®BZ-54 products were used in foam; however, no TBPH releases were observed. 

Stapleton et al., (Stapleton et al., 2008a) were not looking for TBPH/TBB when an unknown 

brominated flame retardant was observed that they identified as the Firemaster®550 

components, suggesting that if TBPH had previously been present in dust from non-foam uses, 

it would likely have been found in earlier sampling. Since the introduction of TBPH/TBB as a 

replacement for PBDEs in foam, they have been detected in environmental monitoring e.g. 

sludge in San Francisco estuaries (Klosterhaus et al., 2009; La Guardia et al., 2010). Given that 

the vapor pressure of e.g. TBPH is very low, release from PVC will likely occur through 

mechanical action, again, suggesting that these particles will be detected in, for example, house 

dust. 

Although insulation has been identified as a source for TBPA-diol and TBPA-diol (mixed esters), 

if used as reactives (See 2.2.2.1), exposure is not expected; however, release from PUF needs to 

be confirmed. EPA/OPPT has found no evidence that these cluster chemicals are present in the 

environment suggesting that exposure to these cluster chemicals is either unlikely or below 

detection levels. EPA/OPPT has not identified current uses for Bromo Alkyl Ester. 

2.5 Hazard Endpoints 

The hazard data for the BPC chemicals are summarized and tabulated in the technical 

supplement [EPA# 740-Q1-4003] titled “Hazard Assessment of the brominated phthalates 

cluster (BPC) chemicals” which can be found at Docket Number EPA-HQ-OPPT-2014-0491 on 

www.regulations.gov. 

2.5.1 Ecological Hazard 

Insufficient experimental data are available to characterize hazard that would result from 

chronic exposure to wildlife population. Currently, information from experimental studies that 

address standard aquatic toxicity endpoints are limited to two chronic invertebrate studies 

conducted on two different species and two different flame retardant formulations 

[Firemaster® BZ-54, PM-PHT-4 Diol and TBPH (>95%)]. These studies present conflicting 

conclusions. Additional studies are available that attempt to address population-level effects. 
 

Page 22 of 52 

These studies would not be sufficient to support a full risk assessment, but can be used to 

support qualitative hazard characterization for the brominated phthalates. These studies 

suggest aquatic and/or sediment dwelling invertebrate populations are likely to be impacted by 

chronic exposure to brominated phthalate flame retardants and suggest high hazard concern. 

Acute toxicity data were available for TBPH/TBB (Firemaster® BZ-54) that also suggest aquatic 

invertebrates as the most sensitive species; however, given the low water solubility and high 

Log Kow of TBPH/TBB and the use of solvents and/or test concentrations above the limit of 

solubility, there is concern that these effects do not represent environmental conditions. 

Additional brominated phthalates presented in the cluster that have lower Log Kow values may 

result in acute hazard, but insufficient acute toxicity information are available to characterize 

the hazard to these chemicals. 

2.5.2 Human Health Hazard 

Structural analogy suggests the potential for reproductive toxicity and “phthalate syndrome” 

associated with the structural analog, bis (2-ethylhexyl) phthalate (DEHP). Limited toxicity data 

are available for the human health endpoints for the brominated phthalates cluster members; 

however, EPA/OPPT has published a screening-level hazard characterization on the phthalate 

esters category (EPA, 2010a) which indicates a broad range of toxicity. 

No hazard data are available for TBB. Available data for some members of the BPC [TBPH 

(purity > 95%)] and for Firemaster® BZ 54 (TBPH/TBB mixture) suggest that the acute oral and 

dermal toxicity in animals is low. The acute inhalation toxicity of TBPA-Diol is high. 

A chronic dietary study with TBPH (purity >95%) did not identify a target organ although 

perturbations in clinical chemistry parameters suggested effects on the liver. In a chronic 

gavage study with Firemaster® BZ 54 (TBPH/TBB mixture), effects on the kidney were observed 

at all doses with females appearing to be more sensitive to exposure. Chronic toxicity data are 

not available for the remaining brominated phthalate cluster members [TBPA-diol, TBPA-diol 

(mixed esters), Bromo Alkyl Ester, Confidential A and Confidential B). 

Data from a two-generation reproductive toxicity study and a prenatal developmental toxicity 

study with the commercial product Firemaster® BZ 54 (TBPH/TBB mixture) showed the 

potential to affect fetal development at high doses. No data are available for 

reproductive/developmental toxicity for the remaining brominated phthalate cluster members 

[TBPH, TBPA-diol, TBPA-diol (mixed esters), Bromo Alkyl Ester, Confidential A and 

Confidential B). 

Genetic toxicity studies indicate that TBPH (purity >95%) is not mutagenic to bacteria but 

induces chromosomal aberrations in vitro. TBPH (purity >95%) did not induce mouse 

micronuclei in vivo. TBPA-diol and TBPA-diol (mixed esters) are not mutagenic to bacteria. No 

genetic toxicity data are available for the remaining brominated phthalate cluster members 

[TBB, Bromo Alkyl Ester, Confidential A and Confidential B]. 
 

Page 23 of 52 

2.6 Results of Problem Formulation 

2.6.1 Conceptual Model 

During problem formulation, a conceptual model (see Figure 2-1) was developed to identify 

important sources, pathways, and receptors of exposure. Potential exposures to the BPC 

chemicals (derived from the manufacture, processing and use of BPS--containing polyurethane 

products) in homes, offices, the environment, and occupational settings were linked to hazard 

endpoints in human and non-human receptors. 

The conceptual model designed to identify important sources, pathways, and receptors of 

exposure, and to link potential exposures to BPC chemicals in dust (derived from PUF and PUF 

products) in homes, offices, the environment, and occupational settings to hazard endpoints 

(responses) of concern is shown in Figure 2-17. The schematic depicts the pathways (arrows) of 

potential exposure to the BPC members found in dust generated during chemical manufacture, 

the manufacture of PUF and PUF products, and the use (and disposal) of PUF and PUF products. 

The dotted lines designate critical areas of data unavailability/uncertainty associated with 

exposure pathways. 

Figure 2-1: Conceptual Model for the Brominated Phthalates Cluster

 

7

 The potential for environmental exposure to BPC chemicals during chemical manufacture is depicted as a potential 

source of environmental exposure but is not being addressed in this assessment. 
 

Page 24 of 52 

EPA/OPPT developed a conceptual model to identify important sources, pathways, and 

receptors of exposure, and to link potential exposures to BPC chemicals in dust [derived from 

polyurethane foams (PUF) and PUF products] in homes, offices, the environment, and 

occupational settings to hazard endpoints (receptors/effects) of concern. The schematic depicts 

the pathways (arrows) of potential exposure to the BPC members found in dust generated 

during manufacture of PUF and PUF products. The dotted lines designate critical data 

gaps/uncertainties associated with the identified exposure pathways. 

2.6.2 Analysis Plan 

Based on concerns for the potential risk of the Brominated Phthalates Cluster (BPC) chemicals 

to human health and the environment, EPA/OPPT, as part of problem formulation, identified 

risk assessment questions to focus the assessment on TSCA uses. The following information is 

known. 

• 1,2-Benzenedicarboxylic acid, 3,4,5,6-tetrabromo-, 1,2-bis(2-ethylhexyl) ester (TBPH) 

and benzoic acid, 2,3,4,5-tetrabromo-, 2-ethylhexyl ester (TBB) have been detected in 

house dust and commercial environments. 

◦ Available hazard data on commercial products and emerging data from targeted 

studies with TBPH and TBB metabolites indicate disruption of thyroid hormone

homeostasis and the potential for effects on testosterone levels. 

• TBPH and TBB have been detected in waterways and remote species. 

◦ Available data on commercial products and TBPH indicate potential acute and 

chronic toxicity. 

Based on the available information and keeping the focus on TSCA uses, the following 

assumptions were made in compiling the assessment questions. 

• The major source of potential environmental and human exposure to the BPC chemicals 

is from the release of the BPC chemicals during polyurethane foams (PUF) manufacture 

or use of PUF products. There may be other sources of exposure for some of the BPC 

chemicals. 

• Measuring TBPH and TBB in dust can be used to monitor potential human exposure 

The general assessment questions are as follows with additional tiering below: 

1. Which BPC chemicals are found in dust in environments where PUF and PUF products 

are manufactured and used? 

2. What data are needed to characterize hazard to BPC chemicals found in dust? 

3. What additional exposure data, if any, are needed to characterize exposure to BPC 

chemicals found in dust? 

4. What is the hazard to human health from the BPC chemicals found in dust? 

5. What is the hazard to sensitive species in the environment from the BPC chemicals 

found in dust? 
 

Page 25 of 52 

6. Are the concentrations of BPC chemicals found in dust a risk to human health and the 

environment? 

A. Environmental Exposure 

1. How persistent and bioaccumulative are the micronized particles of foam containing the 

BPC chemicals? 

2. Are the BPC chemicals persistent and bioaccumulative in the environment? If not “P”, 

are the degradates? 

3. Are non-dust releases to the environment during the manufacture of BPC chemicals 

more significant than BPC releases from PUF? 

4. What releases to the environment occur during the production of PUF and manufacture 

of articles containing PUF (particulates and dust)? 

a. How does the type of PUF relate to the amount released? 

b. Is this release relevant for the BPC chemicals covalently bound to the polymer 

backbone? 

5. Are there environmental releases of BPC chemicals from PUF during use and disposal of 

commercial or consumer products containing PUF? 

a. Can the analogous release of non-BPC FR be used as a surrogate for BPC 

releases? 

6. What hazard data need to be developed to address the potential risk to environmental 

species associated with any or all of these exposures? 

a. For BPC released chemicals? 

b. For persistent degradation products? 

B. Occupational Exposure 

No information is available on the potential exposure to workers during manufacture of the 

BPC chemicals, PUF manufacture and processing, or the use of products containing PUF. 

Available data for TBPH and TBB suggest that there is the potential for occupational 

exposure. 

1. What is the potential worker exposure to BPC chemicals during their manufacture? 

2. What is the potential worker exposure to BPC chemicals during the manufacture of PUF 

and manufacture of articles containing PUF (particulates and dust)? 

a. Does the potential worker exposure differ between BPC chemicals used as 

additives versus BPC chemicals used as reactives? 

3. What is the potential worker exposure to BPC chemicals from the use of commercial or 

consumer products containing PUF? 

a. Does the potential worker exposure differ between BPC chemicals used as 

additives versus BPC chemicals used as reactives? 

4. What hazard data need to be developed to address the potential risk to human health 

associated with any or all of these exposures? 
 

Page 26 of 52 

C. General Population and Consumer Exposure 

TBPH and TBB have been detected in house dust. However, TBPA-diol and TBPA-diol (mixed 

esters), including the primary degradation product tetrabromophthalic acid, have not been 

reported in literature as being present in the environment. The diols are the reactive BPC 

chemicals that are incorporated into the polymer structure via covalent bonds. This suggests 

that unlike TBPH and TBB, they are not being released from the PUF or from PUF 

manufacturing and processing facilities; or that if emission occurs, degradation is fast enough to 

prevent measurable accumulation. Information on the remaining BPC chemicals, Confidential A

and Confidential B, cannot be released. 

1. What is the potential consumer exposure to BPC chemicals in dust from the use of PUF 

and PUF products? 

a. Does the potential consumer exposure differ between BPC chemicals used as 

additives versus BPC chemicals used as reactives? 

2. What hazard data need to be developed to address the potential risk to human health 

associated with any or all of these exposures? 

3. Which PUF products contain BPC chemicals? 

4. How do releases to the environment contribute to levels of TBPH or TBB found in dust 

from PUF potentially lead to general population exposure (e.g. particulates/dust from 

PUF manufacture and use)? 

5. Are there TBB / TBPH dust releases that contribute to levels in the environment / biota? 

2.6.3 Sources and Pathways Excluded From Further Assessment 

In general, the data gaps preclude excluding sources and pathways from further assessment. 

However, the potential for environmental exposure to BPC chemicals during chemical 

manufacture may be a potential source of exposure. Assessment is contingent on obtaining 

information on releases of FR to the environment and the continued regulation of the releases 

of TBB to water. 

2.6.4 Uncertainties and Data Gaps 

Data gaps and data needs have been identified for the Brominated Phthalates Cluster (BPC) 

chemicals. However, data gaps are not necessarily data needs for a risk assessment. Figure 2-2 

to Figure 2-7 outline the tiering of the data needs. Figure 2-2 depicts the overall source of dust 

from polyurethane foams (PUF). The BPC chemicals can be distinguished by the way they are 

predominantly used in PUF: additive or reactive use. Use as either additive or reactive in PUF is 

not precluded; however, the literature suggests that they are predominantly used as one or the 

other. TBPH, TBB and the Bromo alkyl ester are typically added to PUF. TBPA-Diol and TBPADiol (mixed esters) are typically reacted into the polymer backbone where they are covalently 

bound. Release from the PUF is not expected and there is no evidence from environmental 

monitoring that they are; however, this needs to be confirmed. The use profiles of Confidential 

A and Confidential B cannot be disclosed. Questions remain as to whether the additive 

migrates out of the foam and if the reactive releases from the foam. 
 

Page 27 of 52 

If it is assumed, based on the covalent bonding, that the reactives once reacted are not 

released from the polymer backbone, as suggested by environmental monitoring, then 

exposure to these BPC chemicals is not expected from their use in PUF and PUF products. When 

exposure isn’t expected, the characterization of hazard is not considered a priority, and while 

there may be hazard data gaps there is no need to generate these data to determine the risk 

for this exposure scenario. If it is determined that the reactives are released from the PUF and 

PUF products, then data are needed to characterize hazard. The data needs are outlined in 

Figure 2-3 and Figure 2-7. If the additive BPC migrates from the PUF and PUF products and 

exposure is likely, data needs have been identified to characterize the hazard to human health 

and the environment. The data needs are outlined in Figure 2-3, Figure 2-4, Figure 2-5 and 

Figure 2-6 and listed in Section 2. 

2.6.4.1 Overview of Data Needs for Hazard and Exposure to Dust during 

Polyurethane Foams (PUF) manufacture and use of PUF Products 

Figure 2-2: Overview of Data Needs for Hazard and Exposure to Dust during Polyurethane Foams (PUF) 

manufacture and use of PUF Products8

Brominated Phthalate Cluster (BPC) chemicals are in Polyurethane Foams (PUF) as a chemical additive or a 

reactant. Use of reactant BPCs that are covalently bonded to the polymer matrix will have a slightly different 

release pathway than additive BPCs as additional more extreme conditions, such as heat, UV process would have 

to be applied in order for the reactant BPC to be released from the PUF substrates. Based on dust monitoring 

data, it appears the conditions for covalent bond breakage are rare since dusts have not been found to contain the 

reactive BPCs. 

 

8

 Confidential A and Confidential B not included: Some Confidential data may be applicable to the data gaps for the 

non-CBI cluster members 
Page 28 of 52 

2.6.4.2 Overview of Data Needs for Ecotoxicity from Environmental Exposure to Bromi

Cluster (BPC) chemicals in Polyurethane Foams (PUF)

Figure 2-3: Overview of Data Needs for Ecotoxicity from Environmental Exposure to Brominated Phthalates Cluster (BPolyurethane Foams (PUF). Figure 2-3 depicts the relationship between the information obtained from environmental fate monitoring and data and the need 

environmental compartments. The data need in an environmental compartment is directly related to the environmental fate of the 

Brominated flame retardants (BFR) have been found in historic Publicly Owned Treatment Works (POTW) sludge samples. The soupotential release from dust from drains in homes and offices cannot be discounted9. POTW sludge and land application of biosolids 

for contamination and as source of exposure to earthworms, birds and humans through food. 

9 (Venkatesan and Halden, 2014) 
Page 29 of 52 

2.6.4.3 Overview of Data Needs for Human Health Hazard from exposure to Brominate

Cluster (BPC) chemicals in Polyurethane Foams (PUF) Dust 

Figure 2-4: Overview of Data Needs for Human Health exposure to dust and TBPH from Polyurethane Foams (PUF) There is evidence in the literature that TBPH is in the environment and in dust in commercial and residential settings. Figure 2-4 show

characterization are available for the reproductive and developmental toxicity endpoints for the commercial mixtures of FiremasterTMBZ-54. Non-guideline data are available for the metabolite (TBMEHP; tetrabromomonoethylhexyl phthalate) and from ToxCastTM. The 

reproductive and developmental effects observed as a result of exposure to commercial products that may be attributable to TBB or 

component of the mixture) is confounded due to the lack of data with individual components. EPA/OPPT has determined that the avconclusively indicate nor discount the potential for reproductive or developmental toxicity. Additional data for hazard characterizatiohealth risks from exposure to TBPH in dust derived from PUF and PUF products to be assessed. 
Page 30 of 52 

Figure 2-5: Overview of Data Needs for Human Health exposure to dust and TBB from Polyurethane Foams (PUF) There is evidence in the literature that TBB is in the environment or in dust found in commercial and residential settings. Figure 2-5 sh

hazard characterization are available for reproductive and developmental toxicity endpoints for the commercial mixtures FiremasterTM

FiremasterTMBZ-54. The nature and extent of reproductive and developmental effects observed as a result of exposure to commercial attributable to TBB or TBPH (or another component of the mixture) is confounded due to the lack of data with individual components

hazard characterization would allow human health risks from exposure to TBB in dust from PUF and PUF products to be assessed. 
Page 31 of 52 

Figure 2-6: Overview of Data Needs for Human Health exposure to dust and Bromo Alkyl Ester from Polyurethane FoamThere is no information in the literature that Bromo Alkyl Ester is being used in commerce in PUF and PUF products or that Bromo Alk

in commercial or residential settings. Confirmation that Bromo Alkyl Ester is not used in PUF would be valuable information for a risk 

there is no use in PUF and PUF-products, no human exposure to Bromo Alkyl Ester from its use in PUF and PUF products is anticipated assumed to be negligible. However, if there is evidence that Bromo Alkyl Ester is being used in PUF and PUF products, hazard and/or echaracterization of Bromo Alkyl Ester would be needed for assessing risks. 
Page 32 of 52 

Figure 2-7: Overview of Data Needs for Human Health exposure to dust and TBPA-DIOL AND TBPA-DIOL (MIXED ESTERSPolyurethane Foams (PUF) There is no information in the literature that TBPA-Diols are being used in commerce in PUF and PUF products or that TBPA-Diols are 

commercial or residential settings. Confirmation that TBPA-Diols are not used in PUF would be valuable information for a risk assessm

no use in PUF and PUF-products, no human exposure to TBPA-Diols from their use in PUF and PUF products is anticipated and the risk 

negligible. However, if there is evidence that TBPA-Diols are being used in PUF and PUF products, hazard and/or exposure characterizwould be needed for assessing risks. 
Page 33 of 52 

2.6.4.4 Releases to the Environment 

2.6.4.4.1 Chemical Manufacture 

Available data allow for a limited screening-level assessment of exposure to TBPH and TBPADiol. The release of TBB to water from manufacturing and processing is regulated by EPA/OPPT 

(40 CFR Section 721.2925). In general, there are uncertainties associated with the media type 

and frequency of releases of the cluster chemicals to the environment. To reduce these 

uncertainties, monitoring information (air, water, effluent) in and around the manufacturing 

facilities would aid the risk assessment. Alternatively, in the absence of monitoring/measured 

data, process specific information including site information, batch size, number of 

hours/batch, number of batches produced/year, days/year of operation, concentration of the 

chemical, release sources, estimated releases, frequency of releases, control technologies used 

to mitigate/reduce the releases, and waste disposal practice would assist in the assessment of 

environmental exposure from the manufacturing sector. 

This information would enable EPA/OPPT to develop environmental release estimates, 

including frequency and media of release for an “average" or a “typical" manufacturing site. 

2.6.4.4.2 Polyurethane Foams (PUF) Manufacture 

There is no readily available information on the environmental releases of the chemicals in this 

cluster during the manufacture of polyurethane foams (PUF). The release of TBB to water from 

manufacturing and processing is regulated by EPA/OPPT (40 CFR Section 721.2925). An existing 

generic scenario for PU flexible foam manufacturing can be used to estimate releases and 

occupational exposures. 

Available data allow for a limited screening-level assessment of releases of TBPH and TBPA-Diol

to the environment, using the generic scenario and non-Confidential Business Information (CBI) 

Chemical Data Reporting (CDR) data. 

Limited data are available for releases to the environment during PUF manufacture. To reduce 

uncertainties, monitoring information (air, water, effluent) in and around the PU manufacturing 

facilities would aid the risk assessment. Alternatively, in the absence of monitoring/measured 

data, process specific information including site information, batch size, number of 

hours/batch, number of batches/year, number of days/year of operation, concentration of the 

chemical, release sources, estimated releases, frequency of releases, and control technologies 

used to mitigate/reduce the releases, and waste disposal practice would aid the risk 

assessment. 

This information would enable EPA/OPPT to develop non site-specific “typical facility” release 

estimates with frequency and media of release. 
Page 34 of 52 

2.6.4.4.3 Manufacture of Products Containing Polyurethane Foams 

(PUF) 

There is no readily available information on the environmental releases of the chemicals during 

the manufacture of products containing PUF. EPA/OPPT can use estimates following the 

approach taken in the New Chemicals Program to prepare a screening-level assessment based 

on a selected number of industries/exposure scenarios for the two chemicals for which data are 

available (TBPH and TBPA-Diol). 

In addition to the inherent uncertainties of the estimates used to prepare a screening-level 

assessment, there would be uncertainties in the estimates of the media and frequency of 

releases. To reduce uncertainties, industry- wide monitoring information (air, water, effluent) in 

and around the relevant facilities would aid the risk assessment. Alternatively, in the absence of 

monitoring/measured data, process specific information including site information, number of 

articles manufactured per hour , number of hours/day, number of days/year, concentration of 

chemical in foam, release sources, estimated releases, frequency of releases, and control 

technologies used to mitigate/reduce the releases, and waste disposal practice would aid the 

risk assessment. 

This information would enable EPA/OPPT to develop release estimates with frequency and 

media of release for one or more “generic facility” using foam containing chemicals in this 

cluster. 

2.6.4.4.4 Occupational Use of Products Containing Polyurethane Foams 

(PUF) 

No release information is available and EPA/OPPT is unable to assess release from the uses of 

products containing PU foam. 

Data needs for an assessment include monitoring information (air, water, effluent) in and 

around the use sites. Alternatively, in the absence of monitoring/measured data, use specific 

information including the number of use sites, detailed description of use scenario, number of 

hours product is used/day, number of use days/year, concentration of chemical in the foam, 

amount of foam in the product, types and number of products per use site, estimated releases, 

frequency of releases, and control technologies used to mitigate/reduce the releases, and 

waste disposal practice would aid the risk assessment. 

This information would enable EPA/OPPT to develop a "typical" use scenario for each use and 

assess releases, media of release and the frequency of release. 
Page 35 of 52 

2.6.4.4.5 Consumer Use of Products Containing Polyurethane Foams 

(PUF) 

Detection of TBPH/TBB in sludge, sediment, and indoor dust indicate a potential for exposures 

to the environment. Detection of both TBPH in remote biota and environmental media 

indicates exposures have occurred and that global transport is occurring as well. Additional 

environmental samples from soil, sludge, sediment, and biota will provide information about 

the prevalence and spread of BPCs in the environment. 

Additional data are needed to understand how, at what rate, and in what form TBPH and TBB

migrate out of many types of products. Source characterization, migration rates, and 

monitoring data are needed to demonstrate how the use of TBPH, TBB and Confidential A in 

certain products may result in subsequent exposure through migration of these chemicals into 

indoor and outdoor environments. 

2.6.4.5 Occupational Exposure 

2.6.4.5.1 Chemical Manufacture 

The chemicals in this cluster are not on the Occupational Safety and Health Administration’s 

(OSHA) list of regulated chemicals (OSHA, 2013). There is some non-confidential CDR 

information on the number of manufacturing workers and concentrations (EPA, 2012a). Based 

on the physical-chemical properties and available information, workers in cluster chemical 

manufacturing operations are not expected to be exposed to the chemicals via inhalation. 

Limited data are available for occupational exposure to the cluster members leading to 

uncertainties in the exposure assessment. To reduce these uncertainties, workplace monitoring 

information (personal and/or area sampling for workers handling the chemical) would aid the 

risk assessment. Alternatively, in the absence of the monitoring data, information on 

manufacturing process, information on worker activities (activities performed during work shift, 

number of work hours/day, days/year of operation, concentration of the chemical and 

identification of worker activities which may result in inhalation exposure), and information on 

workplace industrial hygiene practices and control technologies would assist in the 

occupational exposure assessment. 

This information would enable EPA/OPPT to develop an occupational exposure assessment for 

the workers at manufacturing sites. 

2.6.4.5.2 Polyurethane Foams Manufacture (PUF) 

Based on limited monitoring data and available information, limited screening-level exposure 

assessment may be possible. Without chemical-specific data, the exposure estimates would be 

based on particulate standards (i.e. total dust) and/or available data on other chemicals being 

monitored. The exposure estimates and the number of workers exposed may not be 

representative of this industry. 
Page 36 of 52 

To reduce uncertainties, industry-wide workplace monitoring data (personal and/or area 

sampling for workers handling the chemical) would aid the risk assessment. Alternatively, in the 

absence of the monitoring data, manufacturing process information, information on worker 

activities (activities performed during work shift, number of work hours/day, number of 

days/year of operation, concentration of chemical and potential sources for inhalation 

exposure), information on workplace industrial hygiene practices and control technologies 

would aid the risk assessment. 

This information would enable EPA/OPPT to develop non site-specific “typical foam 

manufacturing facility” occupational exposure estimates. 

2.6.4.5.3 Manufacture of Products Containing Polyurethane Foams 

(PUF) 

No data are available on occupational exposure to the cluster chemicals during the 

manufacture of products containing PU foam. Based on OSHA’s Particulates Not Otherwise 

Regulated (inhalable and respirable dust) a "high-end" exposure can be determined. 

To reduce uncertainties, industry-wide workplace monitoring information (personal and/or 

area sampling for workers handling the chemical) would aid the risk assessment. Alternatively, 

in the absence of the measured data, process information, information on worker activities 

(activities performed during work shift, number of work hours/day, days/year of operation, 

concentration of chemical and potential sources for inhalation exposure), information on 

workplace industrial hygiene practices and control technologies would aid the risk assessment. 

This information would enable EPA/OPPT to develop non site-specific “typical facility” 

occupational exposure estimates. 

2.6.4.5.4 Occupational Use of Products Containing Polyurethanes Foams 

(PUF) 

No data are available on occupational exposure to the cluster chemicals during the use of 

products containing PUF. 

To reduce uncertainties, industry wide workplace air monitoring information would aid the risk 

assessment. Alternatively, in the absence of the measured data, use information, number of 

use sites, information on worker activities (activities performed during work shift, number of 

work hours/day, days/year of operation, concentration of chemical and potential sources for 

inhalation exposure), information on workplace industrial hygiene practices and control 

technologies would aid the risk assessment. 

This information would enable EPA/OPPT to develop a "typical" use scenario for each use and 

assess occupational exposure assessment for each use. 
Page 37 of 52 

2.6.4.6 Consumer Exposure from Use of Products Containing 

Polyurethane Foams (PUF) 

The exposure potential of TBPH and TBB is influenced by several parameters of the source 

material to which these chemicals are added. One of the major sources of exposure is 

considered to be certain types of polyurethane (PU) foam products based on the following 

criteria as compared to other product end uses: major use-based production volume, higher 

percent of flame retardant chemicals within the product, long service life/product use within 

indoor environments, diverse set of large articles with large surface areas exposed, and 

multiple sources present within various indoor environments. 

Additional information is needed to develop source characterization which includes the type of 

foam linked with the type of end-use product, the percent weight of chemical within the 

product, and properties of the foam, including density, rigidity, and structure. Differences in 

density, rigidity, and structure (closed vs. open cell) along with the thickness of the product and 

its exposed surface area influence the likelihood of migration and associated exposure potential 

of TBB and TBPH over time. Lower density, thinner, open-cell flexible foams, with large 

amounts of exposed surface area have may have greater potential for additive migration over 

time. However, it is not clear if there may be threshold values for one or a combination of these 

factors that could influence migration and exposure potential. Therefore, additional 

information is needed on the migration of additive chemicals out of Polyurethane Products, 

which include data on the thickness of product; surface area exposed; diffusion coefficient; 

partition coefficient; and migration rate of FR over time. 

Additionally, monitoring data for indoor environments, homes, commercial buildings, cars, 

trains, where high concentrations of polyurethane products are present would decrease the 

level of uncertainty. 

2.6.4.7 Human Health Data Assessment 

The potential for exposure to the brominated phthalates cluster (BPC) members during 

chemical manufacture is not clearly understood. Similarly, there is evidence for potential 

exposure to some of the cluster members during occupational use of products containing some 

of the cluster members. There is also evidence to suggest potential consumer exposure to the 

BPC members during the use of some of the products containing some of the BPC members. 

An overview of the data for the structural analog, bis (2-ethylhexyl) phthalate (DEHP; CASRN 

117-81-7), was presented. It could be argued that conservatively, these data could be used to 

characterize the hazard for the brominated phthalates cluster (BPC) members. However, 

available data suggest that the mode of action of DEHP that elicits chronic (specifically 

reproductive and developmental) toxicity is not the same as that of the BPC members. In 

addition, the available data support this hypothesis. There is uncertainty characterizing the 

hazard for the BPC members because the chronic (including reproductive/developmental) 

toxicity observed in animal studies with the BPC members is via a mode of action not 
Page 38 of 52 

considered relevant to humans or at concentrations that either do not raise immediate 

concerns, or which are difficult to attribute to a particular chemical because the data were 

obtained using a commercial mixture. 

Based on the available data for TBPH, there is a low hazard for acute toxicity. In the screeninglevel dietary study in rats with TBPH (described in the technical supplement), the potential for 

liver toxicity was observed by perturbations in clinical chemistry values. However, some liver 

effects have been attributed to a mode of action, peroxisome proliferation (PPARα), not 

considered relevant to humans (Springer et al., 2012). The 28-day repeated-dose study, twogeneration reproductive toxicity study and a prenatal developmental toxicity study with the 

commercial product Firemaster® BZ 54 (TBPH/TBB mixture), showed the potential to affect 

fetal development at high doses. In addition, it appears that the kidney is a potential target 

organ. The uncertainty of using these data to characterize the hazard for TBPH or TBB lies in the 

attribution of the toxicity observed to either mixture component. No toxicity studies with TBB

alone are available; however, given that the metabolites of TBPH and TBB are different, it is 

expected that any toxicity observed would not be by the same mode of action or attributable to 

the same chemical. (Springer et al., 2012) observed the potential for endocrine disruption with 

the metabolites of TBPH and TBB suggesting that the potential for reproductive/ 

developmental toxicity needs to be explored further. Screening level data do not suggest a 

concern for carcinogenicity with TBPH and the potential for a mode of action not relevant to 

humans (PPARα) further lowers the potential concern and the need for data for this chronic 

toxicity endpoint. 

No data are available for Bromo Alkyl Ester. The acute toxicity of TBPA-Diol and TBPA-Diol

(mixed esters) is considered low. No data for repeated-dose or reproductive/developmental 

toxicity are available for TBPA-Diol and TBPA-Diol (mixed esters). The need for human health 

data for these chemicals is dependent on the potential exposure during manufacture and the 

potential for at least TBPA-Diol and TBPA-Diol (mixed esters) to be released from the polymer 

backbone. No uses have been identified for Bromo Alkyl Ester. 

The available toxicity data for TBPH and TBB are considered adequate for use in a screeninglevel assessment based on the criteria described by (Klimisch et al., 1997). The data for TBPH

were submitted to both EPA/OPPT and the European Chemicals Agency (ECHA) under the HPV 

Challenge Program10 and REACH11, respectively. 

The available data for TBB were submitted to EPA/OPPT as data on the commercial product, 

Firemaster®BZ-54 (Chemtura, 2012a) and are considered adequate for use in screening-level 

assessments as described by (Klimisch et al., 1997). 

 

10 United States High Production Volume (HPV) Challenge Program was a voluntary chemical data program 

administered by EPA and is described at: http://www.epa.gov/chemrtk/index.htm

11 Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) is the European Union chemical 

regulatory program administered by ECHA and is described at: http://echa.europa.eu/web/guest/regulations/reach/
Page 39 of 52 

The available data for TBPA-Diol and TBPA-Diol (mixed esters) are similarly considered 

adequate as described above. 

No data are available for Bromo Alkyl Ester. 

2.6.4.8 Environmental Data Assessment 

For environmental fate and bioaccumulation, comprehensive studies are needed for many 

endpoints for all cluster members. All cluster members should be tested individually and all 

major degradation products should be quantified. Comprehensive bioaccumulation studies are 

needed for all BPC cluster members, and these should include several aquatic and terrestrial 

species selected from organisms commonly used in bioaccumulation testing. This would assist 

in the determination of appropriate data needs for the ecotoxicity endpoints. 

Insufficient data are available for brominated phthalates cluster members to support a category 

approach for assessing environmental hazard. Thus, each member will be considered 

independently to establish a preliminary testing approach. The testing approach may be subject 

to modifications based on the availability of fate and monitoring data that may inform on the 

likely routes of environmental exposure. 

Even though a category approach cannot currently be supported, use information (i.e., additive 

or reactive flame retardants) infers certain fate characteristics that suggest exposure pathways 

likely to affect the preliminary testing strategy. The additive flame retardants all have high 

experimental Log Kow values (≥8.8) and predicted Log Koc values (≥4.5) suggesting predominant 

partitioning to sediment and soil and unlikely exposure in the water column. Cluster members 

identified as additive flame retardants include TBPH and TBB. The reactive flame retardants 

generally have Log Kow values <5 suggesting their presence in the water column; however, use 

entails reacting the flame retardants into products suggesting these substances are less likely to 

distribute into the environment that may be better characterized with submission of fate data. 

Cluster members identified as reactive flame retardants include 2-(2-Hydroxyethoxy) ethyl 2-

hydroxy propyl 3,4,5,6 tetrabromobenzene dicarboxylate (CASRN 20566-35-2) and 3,4,5,6 

tetrabromo-1, 2-benzene dicarboxylic acid, mixed esters with diethylene glycol and propylene 

glycol (CASRN 77098-07-8). Use information is limited for 1, 2-(2, 3-dibromopropyl) benzene 

dicarboxylate (CASRN 7415-86-3), Confidential A and Confidential B.

For all cluster members, experimental environmental hazard data are limited to water column 

organisms. Available acute toxicity data suggest aquatic invertebrates as the most sensitive 

species; however, available data for this taxa are limited to the low water solubility and high 

Log Kow additive flame retardants TBPH and the commercial mixture, Firemaster®BZ54 (i.e.,

TBPH and TBB) and. Available chronic aquatic toxicity data are limited to two chronic studies 

with two different species of invertebrates using the additive flame retardants TBPH and the 

commercial mixture Firemaster®BZ54 (i.e., TBPH and TBB). Given the low water solubility 

characteristics of these additive substances, future testing recommendations should resolve 

conflicting conclusions provided in chronic invertebrate toxicity testing. Testing should be 
Page 40 of 52 

completed using the individual cluster members and not the commercial mixtures. Remaining 

cluster members (i.e., reactive flame retardants and TBPA-Diols) are more likely to reside in the 

water column, but limited data (e.g., a single experimental fish acute toxicity test and no fate 

testing) hinder hazard determination. Thus, for these lower Log Kow substances, testing 

recommendations should be based on the results of physiochemical and fate testing and should 

include preliminary acute water column toxicity tests. 

Experimental monitoring data are available that suggest likely exposure of TBPH and TBB to 

organisms that do not currently have corresponding hazard data. Since detection of these 

cluster members in the environment suggests potential for long term exposure to wildlife, 

chronic testing is recommended to address those organisms likely exposed in order to 

characterize potential population level effects. TBPH and TBB have been detected in several 

species of birds, terrestrial mammals, aquatic mammals, fish, aquatic invertebrates, and 

sediment-dwelling invertebrates. Proposed test strategies for health effects will be considered 

prior to testing recommendations to address detected concentrations in mammals. Detection 

in fish, aquatic invertebrates, and sediment-dwelling invertebrates suggest potential for 

exposure and uptake by organisms present in water bodies including aquatic plants and thus, 

hazard and bioaccumulation characterization is needed for these organisms. Hazard data are 

needed to understand the detected concentrations in avian species, as well as exposure and 

fate testing given the variable exposure routes likely for birds and the absence of experimental 

data to characterize chronic hazard. Detected concentrations have also been reported in 

sediment and biosolids suggesting potential routes of exposure. Based on concentration 

detected in these media, hazard characterization of terrestrial invertebrates and terrestrial 

plants is needed in addition to previously described testing of sediment-dwelling invertebrates. 

Given the limitations of monitoring studies (i.e., no representation of potential degradates, 

availability of only TBB and TBPH data, and insufficient coverage of potentially exposed 

organisms such as plants), if additional data on physicochemical and fate parameters become 

available, additional exposure scenarios will be assessed. Testing recommendations will focus 

on cluster members designated as reactive flame retardants, confidential substances (public 

information not available), and TBPA-Diols, as well as potential degradates for all cluster 

members. 
Page 41 of 52 

3 DATA NEEDS ASSESSMENT 

3.1 Data Needs Conclusions – Additive Brominated Phthalate Cluster (BP

 Table 3-1: Data Needs Assessment (DNA) 

Additive* BPC Chemicals: These chemicals are added to the flexible polyurethane foams (PUF) formulation and it is anticipateddata, that they are migrating through the foams and being released from the foams

AVAILABLE INFORMATION DATA GAPS DATA N

BPC 

Chemical & 

CASRN 

Worker 

Exposure 

** 

Releases 

to 

Environment 

General 

population

/ 

Consumer 

exposure 

Worker 

exposure

*** 

Releases 

to 

Environment 

General 

population/ 

Consumer 

exposure 

Worker 

exposure 

Relea

to 

Environ

EXPOSURE

COMMENT TBPH and TBB have been detected in 

the home and in the environment.

Rate of migration of TBPH and TBB from 

PUF and PUF products

Rate of migration of TB

PUF and/or PUF produ

TBPH 

26040-51-7

Modeling and estimates available See 

footnote 

• Manufacturing Process 

Description for BPC chemical and PU foam & PU foam product

• Type of PU foam 

associated with PU foam product

• Amount of PU foam used 

in final PU foam product

• Percent weight of 

chemical in PU foam & PU foam product

• Migration of chemical out 

of PU foam product

• Monitoring human 

exposure (blood)

• Source/

quantity/media of releases

• Waste 

Disposal

• Products 

containing BPC chemical

• Environm

ental sampling (soil, sludge, 

• Man

Descchemprod

• Type 

with 

• Amo

final 

• Perce

chemprod

• Migr

out o

• Mon

expo
Page 42 of 52 

Additive* BPC Chemicals: These chemicals are added to the flexible polyurethane foams (PUF) formulation and it is anticipateddata, that they are migrating through the foams and being released from the foams

AVAILABLE INFORMATION DATA GAPS DATA N

BPC 

Chemical & 

CASRN 

Worker 

Exposure 

** 

Releases 

to 

Environment 

General 

population

/ 

Consumer 

exposure 

Worker 

exposure

*** 

Releases 

to 

Environment 

General 

population/ 

Consumer 

exposure 

Worker 

exposure 

Relea

to 

Environ

TBB 

183658-27-

7

sediment)

• Biota 

Bromo alkyl samples

ester 

7415-86-3

HAZARD – ENVIRONMENTAL FATE & ECOTOXICITY COMMENT TBPH and TBB have been detected in the home and in the environment.

COMMENT Most data for physical-chemical 

properties and environmental fate are estimated.

Experimental data for physical –chemical properties and environmental fate

Experimental data for p

properties and environm

TBPH 

26040-51-7

Available chronic toxicity data (TBPH purity >95%) are inconclusive

Reliable chronic toxicity data Reliable chronic toxicity 

appropriate environme

TBB 

183658-27-

7

Available chronic toxicity data (Firemaster®BZ-54) are inconclusive

Bromo 

Alkyl Ester 

7415-86-3 

No Data Acute and chronic toxicity data set for 

fish, invertebrates and algae

Exposure pathways neebefore data needs can b

HAZARD – HUMAN HEALTH 

COMMENT TBPH and TBB have been detected in the home and in the environment.

TBPH 

26040-51-7

28-d (dietary) (TBPH purity >95%) NOAEL = 233 mg/kg-day [decreased body weights and effects on clinical chemistry]

• Reliable information to 

characterize the hazard for reproductive/developmental toxicity

• Reliable inform

characterize threproductive/dtoxicity
Page 43 of 52 

Additive* BPC Chemicals: These chemicals are added to the flexible polyurethane foams (PUF) formulation and it is anticipateddata, that they are migrating through the foams and being released from the foams

AVAILABLE INFORMATION DATA GAPS DATA N

BPC 

Chemical & 

CASRN 

Worker 

Exposure 

** 

Releases 

to 

Environment 

General 

population

/ 

Consumer 

exposure 

Worker 

exposure

*** 

Releases 

to 

Environment 

General 

population/ 

Consumer 

exposure 

Worker 

exposure 

Relea

to 

Environ

• low acute toxicity

• potential long-term liver effects in 

animal studies which may or may not be by mode of action relevant to humans

• potential 

reproductive/developmental effect unclear [no data on pure chemical]

• potential for endocrine effects 

[thyroid and testes]

• Additional Data for Firemaster BZ54 (see CASRN 

• 183658-27-7)

• Evaluation of e

[thyroid and tereproductive/dtoxicity

TBB 

183658-27-

7

Available data for (oral gavage) reproductive/developmental toxicity is on commercial product Firemaster®BZ54 which is a mixture of TBPH/TBB. It is 

not clear if toxicity observed is attributable to TBB or TBPH

NOAEL (Firemaster®BZ-54) = 50 mg/kg-day • Low acute toxicity (oral/dermal)

• 28-d (oral) NOAEL = not 

established LOEL = 160 mg/kg-day (kidney identified as target organ)

Acute and chronic (repeated/reproductive/developmental) toxicity data set

• Reliable inform

characterize threproductive/dtoxicity

• Evaluation of p

effects [thyroid 
Page 44 of 52 

Additive* BPC Chemicals: These chemicals are added to the flexible polyurethane foams (PUF) formulation and it is anticipateddata, that they are migrating through the foams and being released from the foams

AVAILABLE INFORMATION DATA GAPS DATA N

BPC 

Chemical & 

CASRN 

Worker 

Exposure 

** 

Releases 

to 

Environment 

General 

population

/ 

Consumer 

exposure 

Worker 

exposure

*** 

Releases 

to 

Environment 

General 

population/ 

Consumer 

exposure 

Worker 

exposure 

Relea

to 

Environ

• Evidence of 

reproductive/developmental toxicity with Firemaster®BZ-54

• potential for endocrine effects

Bromo 

Alkyl Ester 

7415-86-3

• acute toxicity unknown

• repeated/reproductive/

developmental toxicity unknown

Acute and chronic (repeated/reproductive/developmental) toxicity data set

No uses have been iden7415-86-3. Data need dpotential for worker expchemical manufacture*

*The nature of Confidential A and Confidential B cannot be disclosed. Data Gaps and Data Needs should be considered for both additive uses.  **Based on the available data for physical-chemical properties, worker inhalation exposure during chemical manufacture is exp

negligible and ingestion is not anticipated in an occupational setting. ***Workplace monitoring information (personal and/or area sampling for workers handling the chemical). In the absence of th

information on manufacturing process, information on worker activities (activities performed during work shift, number of wor

days/year of operation, concentration of the chemical and identification of worker activities which may result in inhalation exinformation on workplace industrial hygiene practices and control technologies would be useful. 
Page 45 of 52 

3.2 Data Needs Conclusions – Reactive Brominated Phthalate Cluster (BP

Table 3-2: Data Needs Assessment 

Reactive* BPC Chemicals: These chemicals are reacted into the polymer backbone of rigid polyurethane foams (PUF). Based on avachemical reactivity and no detection in the environment), it is not anticipated that these chemicals are released from the PU foam ocan be used as additives, available data suggest that the predominant use is as a reactive substance.

AVAILABLE INFORMATION DATA GAPS DATA N

BPC 

Chemical & 

CASRN 

Worker 

exposure 

** 

Releases to 

environment 

General 

population

/ 

Consumer 

exposure 

Worker 

exposure 

*** 

Releases to 

environment 

General 

population

/ 

Consumer 

exposure 

Worker 

exposure 

Rele

envi

EXPOSURE

FOR ALL Not detected in the environment. Release from PUF unknown. Release of ‘reactives’ fro

products

TBPA-Diol 

20566-35-2

Modeling and estimates available

• Not detected in 

environmental monitoring. 

• No other release data 

are available (e.g. from industrial sources)

See *** Footnote 

• Manufacturing Process 

Description for BPC chemical and PUF and PUF products

• Potential for release 

from PUF and PUF products

• Source/• quantity/

media of releases

• Waste 

Disposal

• Products 

containing BPC chemical

• • 

TBPA-Diol

(mixed 

esters) 

77098-07-8

HAZARD – ENVIRONMENTAL FATE & ECOTOXICITY 

FOR ALL Most data for physical-chemical 

properties and environmental fate are estimated.

Experimental data for physical –chemical properties and environmental fate

Experimental data for phyproperties and environme

TBPA-Diol 

20566-35-2

Acute toxicity data for fish only Acute toxicity data set for invertebrates 

and algae and chronic toxicity data set for fish, invertebrates and algae

Exposure pathways (i.e. reproducts and environmen
Page 46 of 52 

Reactive* BPC Chemicals: These chemicals are reacted into the polymer backbone of rigid polyurethane foams (PUF). Based on avachemical reactivity and no detection in the environment), it is not anticipated that these chemicals are released from the PU foam ocan be used as additives, available data suggest that the predominant use is as a reactive substance.

AVAILABLE INFORMATION DATA GAPS DATA N

BPC 

Chemical & 

CASRN 

Worker 

exposure 

** 

Releases to 

environment 

General 

population

/ 

Consumer 

exposure 

Worker 

exposure 

*** 

Releases to 

environment 

General 

population

/ 

Consumer 

exposure 

Worker 

exposure 

Rele

envi

TBPA-Diol

(mixed 

esters) 

77098-07-8 

No Data Acute and chronic toxicity data set for fish, 

invertebrates and algae

determined before specifiidentified.

HAZARD – HUMAN HEALTH 

TBPA-Diol 

20566-35-2

• low acute toxicity

• potential repeated/reproductive/

developmental toxicity unknown

Repeated-dose and reproductive/developmental toxicity

Potential for worker and cneeds to be evaluated to d

TBPA-Diol needs.

(mixed 

esters) 

77098-07-8

*The nature of Confidential A and Confidential B cannot be disclosed. Data Gaps and Data Needs should be considered for both rea**Based on the available data for physical-chemical properties, worker inhalation exposure during chemical manufacture is expecte

ingestion is not anticipated in an occupational setting. *** Workplace monitoring information (personal and/or area sampling for workers handling the chemical). In the absence of the minformation on manufacturing process, information on worker activities (activities performed during work shift, number of work hooperation, concentration of the chemical and identification of worker activities which may result in inhalation exposure), and infor

industrial hygiene practices and control technologies would be useful. 
Page 47 of 52 

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Page 52 of 52 

APPENDICES 

Table_Apx A-1: Comparison of Different Polyurethane Foam Products