v/EPA
United States
Environmental Protection Agency
EPA Document** 740-Q1-4004
August 2015
Office of Chemical Safety and
Pollution Prevention
TSCA Work Plan Chemical
Problem Formulation and Data Needs Assessment
Brominated Phthalates Cluster
Flame Retardants
Br
Br O
Br
O-Alkyl
O-Alkyl
CASRN
26040-51-7
183658-27-7
20566-35-2
77098-07-8
7415-86-3
*
*
NAME
1,2-Benzenedicarboxylic acid, 3,4,5, 6-tetrabromo-, l,2-bis(2-
ethylhexyl) ester
Benzole acid, 2,3,4,5-tetrabromo-, 2-ethylhexyl ester
1,2-Benzenedicarboxylic acid, 3,4,5, 6-tetrabromo-, l-[2-(2-
hydroxyethoxy)ethyl] 2-(2-hydroxypropyl) ester
1,2-Benzenedicarboxylic acid, 3,4,5, 6-tetrabromo-, mixed
esters with diethylene glycol and propylene glycol
1,2-Benzenedicarboxylic acid, l,2-bis(2,3-dibromopropyl) ester
Confidential A
Confidential B
* Confidential Business Information
August 2015
-------
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
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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-l: Comparison of Different Polyurethane Foam Products 52
LIST OF FIGURES
Figure 2-1: Conceptual Model forthe 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
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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:
MarkTownsend, 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.
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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)
KOW OctanohWater partition coefficient
Ib Pound
LOEL Lowest Observed Effect Level
Log K Logarithmic octanohwater 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-, l-[2-(2-hydroxyethoxy) ethyl] 2-(2-hydroxypropyl) ester
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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
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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-, l,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-, l-[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, l,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, l,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/Methodologv%20for%20HBP%20under%20ChAMP March%202009.pdf
And EPA Risk Assessment Guidance at: http://www.epa.gov/raf/
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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
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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
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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
r DC
" "r" "if
183658-27-7
TBB: Benzoicacid, 2,3,4,5-
tetrabromo-, 2-ethylhexyl
ester
20566-35-2
TBPA-Diol: 1,2-
Benzenedicarboxylic acid,
3,4,5,6-tetrabromo-, l-[2-
(2-hydroxyethoxy)ethyl] 2-
(2-hydroxypropyl) ester
Br O r
JL J-L J
1C
"
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)
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CASRN
77098-07-8
7415-86-3
CONFIDENTIAL A
CONFIDENTIAL B
NAME
TBPA Diol (mixed esters):
3,4,5,6 tetrabromo-1,2-
benzene dicarboxylic acid,
mixed esters with
diethylene glycol and
propylene glycol
Bromo Alkyl Ester: 1,2-
Benzenedicarboxylic acid,
l,2-bis(2,3-dibromopropyl)
ester
*
*
STRUCTURE
Br O X/'~XOH
•XplyL-L*
Br O
Representative Structure
Br
L Br
0
/\^^\ ^ Br
|
^^\/'0\^A^Br
0
*
*
*Confidential Business Information
1,2-Benzenedicarboxylicacid, 3,4,5,6-tetrabromo-, l,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-, l-[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-, l,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
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(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 FR-
treated 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
(Marklundetal., 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.
Firemastere550 and FiremastereBZ-54) which show potential toxicity to human health and the
environment and whose effects are difficult to attribute to a particular BPC chemical without
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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.
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/Metfaodologv%20for%20HBP%20under%20ChAMP March%202009.pdf
and EPA Risk Assessment Guidance at: http://www.epa.gov/raf/
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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/proiects/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-
Ql-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 14 of 52
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(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-l).
The report describes the cluster members in terms of their application in PUF and PUF-
containing products as either additives or reactives.
2,^^^
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 15 of 52
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2.2.1.1 TBPHandTBB
1,2-Benzenedicarboxylic acid, 3,4,5,6-tetrabromo-, l,2-bis(2-ethylhexyl) ester (TBPH) and
benzole 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 16 of 52
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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-Benzenedicarboxylicacid, 3,4,5,6-tetrabromo-, l-[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 17 of 52
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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-OPPT-
2003-0071-0004).
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
NotonTRI
TBB: CASRN 183658-27-7
2006 IUR CDR National PV information for the
chemical withheld.
2012 CDR National PV information for the chemical
withheld.
NotonTRI
TBPA-Diol: CASRN 20566-35-2
2006 IUR PV= no record
2012 CDR PV = 1 to 10 million pounds
NotonTRI
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.
NotonTRI
Page 18 of 52
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Cluster Member
Bromo Alkyl Ester: CASRN 7415-86-3
Confidential A
Confidential B
Reporting
2006 IURPV = no record
2012 CDR = no record
NotonTRI
Consent Order - testing PV not triggered
2012 CDR National PV information for the
withheld.
chemical
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/m3TWA (time weighted average) [29 CFR 1910.1000
Table Z-l (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 19 of 52
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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 20 of 52
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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 semi-
volatile 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 forTBPH/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 21 of 52
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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 22 of 52
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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.
SOURCES
EXPOSURE PATHWAYS
RECEPTORS
EFFECTS
Brominate
Phthalates Cluster ^™
(BPC) Manufacture'
p
Processing of PUF
1
^ __
WWTP
BIO5O
fc 1 Landfill
4 Commercial Use of L
r
^ Consumer Use of —
PUF/Products
Dust from I
^^^" Manufacturing r^^
L aproce"ing J ,
-^ Surface Water
TŁ If
TT
Sediment
'LJ
f
^ Dust from
Product
1
1
'" -1
"•""I
— !
•«- — — J
1
Installation 1
E~ — — — ^1 Inhalation
— — — — J^ 1 Dermal
" """"^f oral
Deposition ; :>
Wl__^_ ^ f Drinking 1
**"! Inhalation
• 1 Or-l
-J 1 +f Workers J __
^ ^ j General ^
_t
^ / (Aquatic, \ _
^k Avian) J
J
^^"^Consumers ^*^^
~~ — — — +( (Adults & J
\w^ Infants) >f
Legend
Solid lines = Pathway can be quantified
P = BPC chemical materials process pathway
Dashed lines = Pathway of unknown significance
Shaded boxes = Elements proposed for inclusion in assessment.
Unshaded boxes = Elements lacking adequate data for assessment
*BPC chemical TBB regulated under SNUR for no release to water
^
Non-Cancer
Health
Effects:
Reproductive
Toxicity &
(e.g. thyroid)
Acute and
Chronic
Toxicity
Non-Cancer
Health Effects:
Reproductive
Toxicity &
Hormones
{e.g. thyroid)
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 23 of 52
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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-, l,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 24 of 52
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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 25 of 52
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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 TBPA-
Diol (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 26 of 52
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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
ASSESS
RISK
BPC IN
PUF
ASSESS
RISK
HAZARD AND
EXPOSURE DATA NEED
See Figures 2-7
1
STABLE
ADDITIVE
REACTIVE
Monomers or
Analytes
Is the BPC
reacted or
added to
PUF?
BOND STABILITY
DATA NEED
UNSTABLE
Depolymerization
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 27 of 52
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2.6.4.2 Overview of Data Needs for Ecotoxicity from Environmental Exposure to Brominated Phthalates
Cluster (BPC) chemicals in Polyurethane Foams (PUF)
High***
Fwie-
« *rf *->-1H(c
T€S
•li-HC rt*1»
H-Tn-.-fSirlift* cfecwi*: -so_P*r-:
*»• -a**! •**o*11otli>i! itala Ui
OsftTA NEED
A^-wrfc* aind/^r C*ir^ntd=
*«|U*tHC t^rfclir-ijf
1 P
IAS5E&S
». |
14J 0*TA«*
!• and p*rt*tin«Jr^i d>ba I Chrurtre b«
I inM*rt***r»fc«
-=nA=-r n| -d*t* in ••drriBrtl I ^^-^ I ^^^^^^^™
.nd t™tnk IHnrt.br.>« I t"J ^ I ASSESS I
ASSESS RISK
D*T* MttO | 1
"'' Aeuu •nel.i'flr chreiiic ***!*»
p-^ lmv*.brwt» ,n^ pl-rrt I *" I TIKRE5TRKUL I
F^e^nd^rtllM^l^-M. t,rt.nE | "'*H
> I g "
Mc-'illO'i^i. i**1»'•< -S<»J AirtifJ I -^ A$S|3$ RISK
Figure 2-3: Overview of Data Needs for Ecotoxicity from Environmental Exposure to Brominated Phthalates Cluster (BPC) chemicals in
Polyurethane Foams (PUF).
Figure 2-3 depicts the relationship between the information obtained from environmental fate monitoring and data and the need for testing in different
environmental compartments. The data need in an environmental compartment is directly related to the environmental fate of the BPC chemicals.
Brominated flame retardants (BFR) have been found in historic Publicly Owned Treatment Works (POTW) sludge samples. The source is uncertain but
potential release from dust from drains in homes and offices cannot be discounted9. POTW sludge and land application of biosolids should be monitored
for contamination and as source of exposure to earthworms, birds and humans through food.
' (Venkatesan and Halden, 2014)
Page 28 of 52
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2.6.4.3 Overview of Data Needs for Human Health Hazard from exposure to Brominated Phthalates
Cluster (BPC) chemicals in Polyurethane Foams (PUF) Dust
•M.-f,- :• .- i- •• I ii ••.•."-
i-ff-r?-, on ttiyrold
hormone levels
Metabolite :hew>
effects on
Endocrine
Disruption letting
data from TocCftU
It there t
pot*ntl*l far
ft»prexiwcttvw
traf
Developmental
Toliidty?
YES
DATA HEED
>--..-,-•-•
be evaluated by
EM
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 shows that data for hazard
characterization are available for the reproductive and developmental toxicity endpoints for the commercial mixtures of Firemaster™550 and Firemaster™
BZ-54. Non-guideline data are available for the metabolite (TBMEHP; tetrabromomonoethylhexyl phthalate) and from ToxCast™. The nature and extent of
reproductive and developmental effects observed as a result of exposure to commercial products that may be attributable to TBB or TBPH (or another
component of the mixture) is confounded due to the lack of data with individual components. EPA/OPPT has determined that the available data neither
conclusively indicate nor discount the potential for reproductive or developmental toxicity. Additional data for hazard characterization would allow human
health risks from exposure to TBPH in dust derived from PUF and PUF products to be assessed.
Page 29 of 52
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ADDITIVE
* TBS
Reproductive
n:l
Developmental
ToKiclty?
DATA NEED
H»l*rtiT**l!nf tobt
ftvalualc-d by
EPA
HAZARD
CHARACTERIZATION
FXPGSLJRF
CHARACTERIZATION
I
ASSESS RISK
Figure 2-5: Overview of Data Needs for Human Health exposure to dust and TBB from Polyurethane Foams (PDF)
There is evidence in the literature that TBB is in the environment or in dust found in commercial and residential settings. Figure 2-5 shows that data for
hazard characterization are available for reproductive and developmental toxicity endpoints for the commercial mixtures Firemaster™550 and
Firemaster™BZ-54. The nature and extent of reproductive and developmental effects observed as a result of exposure to commercial products that may be
attributable to TBB or TBPH (or another component of the mixture) is confounded due to the lack of data with individual components. Additional data for
hazard characterization would allow human health risks from exposure to TBB in dust from PUF and PUF products to be assessed.
Page 30 of 52
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ADDITIVE
*
Bromo
Alky!
Ester
YES
NO
RELEASED
FROM
PUF?
YES
NO
ASSESS
RISK
ASSESS
RISK
DATA NEED
Hazard Testing to
be evaluated by
EPA
I
HAZARD
CHARAOTRI7ATION
EXPOSURE
CHARACTERIZATION
1
ASSESS RISK
Figure 2-6: Overview of Data Needs for Human Health exposure to dust and Bromo Alkyl Ester from Polyurethane Foams (PUF)
There is no information in the literature that Bromo Alkyl Ester is being used in commerce in PUF and PUF products or that Bromo Alkyl Ester is found in dust
in commercial or residential settings. Confirmation that Bromo Alkyl Ester is not used in PUF would be valuable information for a risk assessment because if
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 and the risk can be
assumed to be negligible. However, if there is evidence that Bromo Alkyl Ester is being used in PUF and PUF products, hazard and/or exposure
characterization of Bromo Alkyl Ester would be needed for assessing risks.
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REACTIVE
- TBPA-
Diol
• TBPA-
Diol
(mixed
astsrs)
RELEASED
FROM
PUF?
HAZARD
CHARACTERIZATION
fXPQSURF
CHARACTFRI7ATION
1
ASSESS RISK
ASSESS RISK
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)
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 found in dust in
commercial or residential settings. Confirmation that TBPA-Diols are not used in PUF would be valuable information for a risk assessment because if there is
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 can be assumed to be
negligible. However, if there is evidence that TBPA-Diols are being used in PUF and PUF products, hazard and/or exposure characterization of TBPA-Diols
would be needed for assessing risks.
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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 TBPA-
Diol. 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 33 of 52
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2.6 A A3 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.
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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/OPPTto 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.
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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/OPPTto 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/OPPTto 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.
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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 37 of 52
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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 screening-
level 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 (PPARa), not
considered relevant to humans (Springer et al., 2012). The 28-day repeated-dose study, 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. 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 (PPARa) 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 screening-
level 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 38 of 52
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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
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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 40 of 52
-------
3 DATA NEEDS ASSESSMENT
3.1 Data Needs Conclusions - Additive Brominated Phthalate Cluster (BPC) Chemicals
Table 3-1: Data Needs Assessment (DNA)
Additive* BPC Chemicals: These chemicals are added to the flexible polyurethane foams (PUF) formulation and it is anticipated, based
data, that they are migrating through the foams and being released from the foams
BPC
Chemical &
CASRN
AVAILABLE INFORMATION
Worker Releases General
Exposure to population
** Environment /
Consumer
exposure
DATA GAPS
Worker
exposure
***
Releases
to
Environment
EXPOSURE
COMMENT
TBPH
26040-51-7
TBPH and TBB have been detected in
the home and in the environment.
Modeling and estimates available
Rate of migration of TBPH
PUF and PUF products
See
footnote
General
population/
Consumer
exposure
on available
DATA NEEDS
Worker
exposure
Releases
to
Environment
and TBB from
• 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 we ght of
chemical in PU foam & PU
foam product
• Migration of chemical out
of PU foam product
• Monitoring human
exposure (blood)
General
population
/
Consumer
exposure
Rate of migration of TBPH and TBB from
PUF and/or PUF products
• Source/
quantity/
media of
releases
• Waste
Disposal
• Products
containin
gBPC
chemical
• Environm
ental
sampling
(soil,
sludge,
• Manufacturing Process
Description for BPC
chemical and PUF & PUF
product
• Type of PUF
associated
with PUF product
• Amount of PUF used in
final PUF product
• Percent weight of
chemical in PUF & PUF
product
• Migration of chemical
out of PUF product
• Monitoring human
exposure (blood)
Page 41 of 52
-------
Additive* BPC Chemicals: These chemicals are added to the flexible polyurethane foams (PUF) formulation and it is anticipated, based
data, that they are migrating through the foams and being released from the foams
BPC
Chemical &
CASRN
TBB
183658-27-
7
Bromo alkyl
ester
7415-86-3
AVAILABLE INFORMATION
Worker
Exposure
**
Releases
to
Environment
General
population
/
Consumer
exposure
DATA GAPS
Worker
exposure
***
Releases General
to population/
Environment Consumer
exposure
on available
DATA NEEDS
Worker
exposure
sediment
)
• Biota
samples
Releases
to
Environment
General
population
/
Consumer
exposure
HAZARD - ENVIRONMENTAL FATE & ECOTOXICITY
COMMENT
COMMENT
TBPH
26040-51-7
TBB
183658-27-
7
Bromo
Alkyl Ester
7415-86-3
TBPH and TBB have been detected in the home and in
Most data for physical-chemical
properties and environmental fate are
estimated.
Available chronic toxicity data (TBPH
purity >95%) are inconclusive
Available chronic toxicity data
(Firemaster®BZ-54) are inconclusive
No Data
the environment.
Experimental data for physical -
chemical properties and environmental
fate
Reliable chronic toxicity data
Acute and chronic toxicity data set for
fish, invertebrates and algae
Experimental data for physical -chemical
properties and environmental fate
Reliable chronic toxicity data for
appropriate environments
Exposure pathways need to be determined
before data needs can be identified.
HAZARD - HUMAN HEALTH
COMMENT
TBPH
26040-51-7
TBPH and TBB have been detected in the home and in
28-d (dietary) (TBPH purity >95%)
NOAEL = 233 mg/kg-day [decreased
body weights and effects on clinical
chemistry]
the environment.
• Reliable information to
characterize the hazard for
reproductive/developmental
toxicity
• Reliable information to
characterize the hazard for
reproductive/developmental
toxicity
Page 42 of 52
-------
Additive* BPC Chemicals: These chemicals are added to the flexible polyurethane foams (PUF) formulation and it is anticipated, based on available
data, that they are migrating through the foams and being released from the foams
AVAILABLE INFORMATION
DATA GAPS
DATA NEEDS
BPC
Chemical &
CASRN
Worker
Exposure
Releases
to
Environment
General
population
/
Consumer
exposure
Worker
exposure
***
Releases
to
Environment
General
population/
Consumer
exposure
Worker
exposure
Releases
to
Environment
General
population
/
Consumer
exposure
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 BZ-
54 (see CASRN
183658-27-7)
Evaluation of endocrine effects
[thyroid and testes] and potential
reproductive/developmental
toxicity
TBB
183658-27-
7
Available data for (oral gavage)
reproductive/developmental toxicity is
on commercial product Firemaster®BZ-
54 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 information to
characterize the hazard for
reproductive/developmental
toxicity
Evaluation of potential endocrine
effects [thyroid and testes]
Page 43 of 52
-------
Additive* BPC Chemicals: These chemicals are added to the flexible polyurethane foams (PUF) formulation and it is anticipated, based
data, that they are migrating through the foams and being released from the foams
BPC
Chemical &
CASRN
Bromo
Alkyl Ester
7415-86-3
AVAILABLE INFORMATION
Worker
Exposure
**
Releases
to
Environment
General
population
/
Consumer
exposure
• Evidence of
reproductive/developmental
toxicity with Firemaster®BZ-54
• potential for endocrine effects
• acute toxicity unknown
• repeated/reproductive/
developmental toxicity
unknown
DATA GAPS
Worker
exposure
***
Releases
to
Environment
General
population/
Consumer
exposure
Acute and chronic
(repeated/reproductive/developmental)
toxicity
data set
on available
DATA NEEDS
Worker
exposure
Releases
to
Environment
General
population
/
Consumer
exposure
No uses have been identified for CASRN
7415-86-3. Data need dependent on the
potential for worker exposure during
chemical manufacture**
*The nature of Confidential A and Confidential B cannot be disclosed. Data Gaps and Data Needs should be considered for both reactive and
additive uses.
**Based on the available data for physical-chemical properties, worker inhalation exposure during chemical manufacture is expected to be
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 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 be useful.
Page 44 of 52
-------
3.2 Data Needs Conclusions - Reactive Brominated Phthalate Cluster (BPC) Chemicals
Table 3-2: Data Needs Assessment
Reactive* BPC Chemicals: These chemicals are reacted into the polymer backbone of rigid polyurethane foams (PUF). Based on available data
chemical reactivity and no detection in the environment), it is not anticipated that these chemicals are released from the PU foam or product
can be used as additives, available data suggest that the predominant use is as a reactive substance.
BPC
Chemical &
CASRN
AVAILABLE INFORMATION
Worker
exposure
**
Releases to
environment
EXPOSURE
FOR ALL
TBPA-Diol
20566-35-2
TBPA-Diol
(mixed
esters)
77098-07-8
General
population
/
Consumer
exposure
DATA GAPS
Worker
exposure
***
Releases to
environment
General
population
/
Consumer
exposure
(nature of
While they
DATA NEEDS
Worker
exposure
Releases to
environment
Not detected in the environment. Release from PUF unknown.
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
General
population/
Consumer
exposure
Release of 'reactives' from PUF and/or PUF
products
• Source/
• quantity/
media of
releases
• Waste
Disposal
• Products
containing
BPC
chemical
• Manufacturing Process
Description for BPC
chemical and PUF and
PUF products
• Potential for release
from PUF and PUF
products
HAZARD - ENVIRONMENTAL FATE & ECOTOXICITY
FOR ALL
TBPA-Diol
20566-35-2
Most data for physical-chemical
properties and environmental fate are
estimated.
Acute toxicity data for fish only
Experimental data for physical -chemical
properties and environmental fate
Acute toxicity data set for invertebrates
and algae and chronic toxicity data set for
fish, invertebrates and algae
Experimental data for physical-chemical
properties and environmental fate
Exposure pathways
products and envirc
i.e. release from PUF and PUF
nmental fate) need to be
Page 45 of 52
-------
Reactive* BPC Chemicals: These chemicals are reacted into the polymer backbone of rigid polyurethane foams (PUF). Based on available data
chemical reactivity and no detection in the environment), it is not anticipated that these chemicals are released from the PU foam or product
can be used as additives, available data suggest that the predominant use is as a reactive substance.
BPC
Chemical &
CASRN
TBPA-Diol
(mixed
esters)
77098-07-8
AVAILABLE INFORMATION
Worker
exposure
**
No Data
Releases to
environment
General
population
/
Consumer
exposure
DATA GAPS
Worker
exposure
***
Releases to
environment
General
population
/
Consumer
exposure
Acute and chronic toxicity data set for fish,
invertebrates and algae
(nature of
While they
DATA NEEDS
Worker
exposure
Releases to
environment
General
population/
Consumer
exposure
determined before specific data needs can be
identified.
HAZARD - HUMAN HEALTH
TBPA-Diol
20566-35-2
TBPA-Diol
(mixed
esters)
77098-07-8
• low acute toxicity
• potential repeated/reproductive/
developmental toxicity unknown
Repeated-dose and
reproductive/developmental toxicity
Potential for worker and consumer exposure
needs to be evaluated to determine specific data
needs.
*The nature of Confidential A and Confidential B cannot be disclosed. Data Gaps and Data Needs should be considered for both reactive and additive uses.
**Based on the available data for physical-chemical properties, worker inhalation exposure during chemical manufacture is expected to be 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 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 be useful.
Page 46 of 52
-------
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Page 51 of 52
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APPENDICES
Appendix A
Table_Apx A-l: Comparison of Different Polyurethane Foam Products
COMPARISON OF DIFFERENT POLYURETHANE FOAM PRODUCTS
Flexible Polyurethane Foam (FPFi is not Rigid Polyurethane Foam (PUR) <>r Spray Polyurethane Foam (SPF).
Different types of foam products use tfiffetvitt raw materiais, frave distinct compositions and utticfac properties and stiott/tf not t>e confused wftft one another.
Type of Foam
Referred to as
Applications
Method of
application
Cell structure
Porosity
Compression
Density
Feel
CAS Number
Resources
Flexible Polyurethane Foam
FPF
Cushloninq in
upholstered furniture
mattresses
carpet cushion
automotve seating
arm rests and headliners
Also, as
apparel padding
shoe insoles
filtration
packaqinq
sponges
applicators
medical and technical
applications
Cut from blocks or molded
Open cell (>90% open cells);
lightly cross-linked
Porous
Recovers when compressed
Low-Medium Density
0.62-4.99 lb/ttA3
Soft
None
Polyurethane Foam Association.
www.pfa.orq (for flexible
Polyurethane foarn only)
Rigid Polyurethane Foam
PUR
Insulation in
• refrigerator walls
• building insulation panels
Also found in:
• decorative and architectural
applications
o molded picture frames
o furniture trim and molding
o exterior building shutters
o detailing created by molding
rather than intricate carving
• flotation modules for docks
Mainly injected, molded or poured as
blocks
Closed cell (> 90% closed cells); highly
cross-linked
Ranges from semi-porous to non-porous
Does not recover when compressed
Medium-High Density
2. 0-25 IB/ft" 3
*25 is forwood-like pictures and carvinqs
Hard
None
American Chemistry Council
Center for the Polyurethanes Industry
www oolyurethanes.orq
Spray PolyurethaneFoam(Rlgid)
SPF
A wide variety of applications including but
not limited to:
• roofing
• air barriers
• insulation
• spray-in-place packaging
• flotation for boats
Spray-applied - installed as a liquid and then
expands manytimes its oriqinal size
Closed cell (> 90% closed cells);
highly cross-linked
Ranges from semi-porous to non-porous
Does not recoverwhen compressed
Medium-High Density
2.0-3.5 Ib/Tt"3
Medium Hard
None
Spray Foam Alliance, www .sprayfoam .orq
(for spray foam only)
Developed by the Polyurethane Foam Association April 2011
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