PEER REVIEW DRAFT - DO NOT CITE OR QUOTE

United States
Environmental Protection Agency
Office of Chemical Safety and
Pollution Prevention
Draft Risk Evaluation for
1-Bromopropane (1-BP)
1-BP Systematic Review Supplemental File:
Data Quality Evaluation for Consumer Exposure
CASRN: 106-94-5
CH
August 2019
NOTICE: This information is distributed solely for the purpose of pre-dissemination peer review
under applicable information quality guidelines. It has not been formally disseminated by EPA. It does
not represent and should not be construed to represent any Agency determination or policy. It is being
circulated for review of its technical accuracy and science policy implications.

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Table of Contents
HERO
ID
Monitoring
3042164
3158732
Data Type
Monitoring
Monitoring
Experimental
1579753	Experimental
Databases Not Unique to a Chemical
3970089
Databases Not Unique to a Chemi-
cal
Completed Exposure Assessments
1519109
3827325
3980936
3982334
4663189
Survey
1005969
Completed Exposure Assessment
Completed Exposure Assessment
Completed Exposure Assessment
Completed Exposure Assessment
Completed Exposure Assessment
Survey
Reference
Jain, R. B.. 2015. Levels of selected urinary metabolites of volatile organic
compounds among children aged 6-11 years. Environmental Research 142
Boyle, E. B.,Viet, S. M.,Wright, D. J.,Merrill, L. S.,Alwis, K. U.,Blount, B.
C.,Mortensen, M. E.,Moye, J.,Dellarco, M.. 2016. Assessment of Exposure to
VOCs among Pregnant Women in the National Children's Study. International
Journal of Environmental Research and Public Health 13
Knoppel, H.,Schauenburg, H.. 1989. Screening of household products for the
emission of volatile organic compounds. Environment International 15
U.S, E. P. A.. 2017. Chemical and product categories: 1-Bromopropane.
Ntp, Cerhr. 2003. NTP-CERHR monograph on the potential human reproduc-
tive and developmental effects of 1-bromopropane.
Atsdr,. 2016. Draft toxicological profile for 1-bromopropane.
Japanese Ministry of, Environment. 2017. 1-Bromopropane.
Atsdr,. 2016. Toxicological profile for 1-bromopropane.
Delmaar, J. E.. Emission of chemical substances from solid matrices: a method
for consumer exposure assessment.
U.S, E. P. A.. 1987. Household solvent products: A national usage survey.
2
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6
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Refer to Appendix E of ' Application of Systematic Review in TSC'A Risk Evaluations' at https://www.epa.gov for more information of evaluation
procedures and parameters.

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Study Citation: Jain, R. B.. 2015. Levels of selected urinary metabolites of volatile organic compounds among children aged 6-11 years.
Environmental Research.
Data Type	Monitoring
Hero ID	3042164
Domain
Metric
Rating^ Score
Comments^-
Domain 1: Reliability
Metric 1: Sampling Methodology
Metric 2: Analytical Methodology
High
High
Metric 3: Biomarker Selection
Medium
NHANES sampling. Detailed description at https:/
/wwwn. cdc.gov/nchs/nhanes/ContinuousNhanes/
Default. aspx?BeginYear=2011
The laboratory methods used to measure VOCs in urine, as
previously mentioned are provided in Alwis et al. (2012) and
at https://wwwn.cdc.gov/nchs/nhanes/ContinuousNhanes/
Default. aspx?BeginYear=2011.
Alwis, K.U., Blount, B.C., Britt, A.S., Patel, D., Ashley,
D.L., 2012. Simultaneous analysis of 28 urinary VOC metabo-
lites using ultra high performance liquid chromatography cou-
pled with electrospray ionization tandem mass spectrometry
(UPLC"ESI/MSMS). Anal.Chim.Acta750,152" 160.
According to the ATSDR Toxicological Profile for 1-
Bromopropane, dated August 2017, "Biological exposure to
the general population and workers can be assessed by mea-
surement of bromide ion, 1-bromopropane, and its metabo-
lite, N-acetyl-S-(n-propyl)-L-cysteine (AcPrCys) in urine or
blood (NTP 2013). N-Acety 1-S-(n-propy 1)-L-cysteine is ex-
pected to be more specific to 1-bromopropane than bromide
due to the presence of the bromide ion in foods; however,
there have also been concerns regarding the specificity of N-
acetyl-S-(n-propyl)-L-cysteine. The ubiquitous nature of N-
acetylS-(n-propyl)-L-cysteine in the urine of the general pop-
ulation suggests that it may not be a specific biomarker for
1-bromopropane, as general population exposure is expected
to be limited. It is unknown if other chemicals and/or endoge-
nous metabolism contributed to the observed urinary levels
of N-acetylS-(n-propyl)-L-cysteine in bio monitoring studies".
The document is available at: https://www.atsdr.cdc.gov/
ToxProfiles/tp.asp?id=1471&tid=285. NTP. 2013. Report on
carcinogens. Monograph on 1-bromopropane. National Toxi-
cology Program, U.S. Department of Health and Human Ser-
vices.
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Domain 2: Representativeness
Metric 4: Geographic Area	High	1
Metric 5: Currency	Medium 2 2011-2012 samples
Continued on next page

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— continued from previous page
Study Citation: Jain, R. B.. 2015. Levels of selected urinary metabolites of volatile organic compounds among children aged 6-11 years.
Environmental Research.
Data Type	Monitoring
Hero ID	3042164
Domain	Metric	Rating^ Score	Comments'
Metric 6: Spatial and Temporal Variability
Metric 7: Exposure Scenario
Medium
Medium
2
2
Large sample size, but appears to be spot samples collected (vs
24 hr or first morning voids)
Domain 3: Accessibility/Clarity
Metric 8: Reporting of Results
Metric 9: Quality Assurance
Medium
Medium
2
2
No raw data, but raw data are available from NHANES. Mean
and 95 percent Confidence Interval provided. No Standard
Deviation.
Study provided creatinine levels to assess completeness of urine
samples
Domain 4: Variability and LTncertainty
Metric 10: Variability and LTncertainty
Medium
2
No SD, but discussed age,gender,race/ethnicity, and exposure
to environmental tobacco smoke.
Overall Quality Determination
Medium
1.7

Extracted
Yes



1 High = 1; Medium = 2; Low = 3; Unacceptable = 4; N/A has no value.
t The overall rating is calculated as necessary. EPA may not always provide a comment for a metric that has been categorized as High.
If any individual metrics are deemed Unacceptable, then the overall rating is also unacceptable. Otherwise, the overall rating is based on the following scale:
High: > 1 to < 1.7; Medium: => 1.7 to < 2.3; Low: => 2.3 to < 3.
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Study Citation: Boyle, E. B.,Viet, S. M.,Wright, D. J.,Merrill, L. S.,Alwis, K. U.,Blount, B. C.,Mortensen, M. E.,Moye, J.,Dellarco, M..
2016. Assessment of Exposure to VOCs among Pregnant Women in the National Children's Study. International Journal of
Environmental Research and Public Health.
Data Type	Monitoring
Hero ID	3158732
Domain
Metric
Rating!" Score
Comments'
Domain 1: Reliability
Metric 1:
Metric 2:
Metric 3:
Sampling Methodology
Analytical Methodology
Biomarker Selection
High	1	Described equipment and storage. Conducted as a part of large
study with protocols.
Medium 2 They used a standard method (in reference section) and pro-
vided some info, but not recoveries reported. LOD is reported.
High.	1 biomarker on CDC list https://www.cdc.gov/Nchs/Data/
Nhanes/Nhanes_ll_12/UVOC_G _MET_VOC_Metabolites.pdf
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Domain 2: Representativeness
Metric 4:
Metric 5:
Metric 6:
Geographic Area	High
Currency	Medium
Spatial and Temporal Variability Medium
Metric 7: Exposure Scenario
High
2009-2010
Medium- Had very large sample size (high), but only spot sam-
ples collected (low)
The study analyzes urine from the general population, and
therefore the concentrations are not specific to consumer sce-
narios of interest to OPPT. The study does, however, have
provide descriptive statistics that provide the frequency of ac-
tivity patterns (paint use, air freshener use, etc.) which may
be useful in characterizing the data.
Domain 3: Accessibility/Clarity
Metric 8: Reporting of Results
Metric 9: Quality Assurance
Medium 2 No Coefficient of Variation (CV). No raw data, but raw data
are available from NHANES
Medium 2 Some QA information is missing from the article, however lab-
oratory QA procedures are provided in Alwis 2012, the pro-
cedure that was also used for NHANES. Alwis, K.U.; Blount,
B.C.; Britt, A.S.; Patel, D.; Ashley, D.L. Simultaneous Anal-
ysis of 28 Urinary VOC Metabolites Using Ultra High Per-
formance Liquid Chromatography Coupled with Electrospray
Ionization Tandem Mass Spectrometry (UPLC-ESI/MSMS).
Anal. Chim. Acta 2012, 750, 152" 160.
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Domain 4: Variability and Uncertainty
Metric 10: Variability and Uncertainty	High	1
Continued on next page

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— continued from previous page
Study Citation: Boyle, E. B.,Viet, S. M.,Wright, D. J.,Merrill, L. S.,Alwis, K. U.,Blount, B. C.,Mortensen, M. E.,Moye, J.,Dellarco, M..
2016. Assessment of Exposure to VOCs among Pregnant Women in the National Children's Study. International Journal of
Environmental Research and Public Health.
Data Type	Monitoring
Hero ID	3158732
Domain	Metric	Rating^ Score	Comments^
Overall Quality Determination	High	1.5
Extracted	Yes
1 High = 1; Medium = 2; Low = 3; Unacceptable = 4; N/A has no value.
$ The overall rating is calculated as necessary. EPA may not always provide a comment for a metric that has been categorized as High.
If any individual metrics are deemed Unacceptable, then the overall rating is also unacceptable. Otherwise, the overall rating is based on the following scale:
High: > 1 to < 1.7; Medium: => 1.7 to < 2.3; Low: => 2.3 to < 3.

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Study Citation: Knoppel, H.,Schauenburg, H.. 1989. Screening of household products for the emission of volatile organic compounds. Envi-
ronment International.
Data Type	Experimental
Hero ID	1579753
Domain
Metric
Rating^
Score
Comments^
Domain 1: Reliability
Metric 1:
Metric 2:
Metric 3:
Sampling Methodology and Conditions
Analytical Methodology
Biomarker Selection
Low
Low
N/A
3
3
N/A
Few details, older crude method.
Few details, no standard method mentioned.
Domain 2: Representative
Metric 4:
Metric 5:
Metric 6:
Testing Scenario
Sample Size and Variability
Temporality
Low
Medium
Low
3
2
3
Testing was conducted on 10 different consumer products
(wood and floor waxes and detergents), but testing was not
conducted over a broad range of conditions. Additionally,
products are not a direct match to the OPPT scenarios of in-
terest.
Although 10 similar types of products were tested, there was
no replicate testing per product.
>15 yrs old
Domain 3: Accessibility/Clarity
Metric 7: Reporting of Results
Metric 8: Quality Assurance
Low
Unacceptable
3
4
No summary of data across product types. No raw data.
QA not mentioned, and no standard methodologies used to
assume QA was done.,
Domain 4: Variability and Uncertainty
Metric 9: Variability and Uncertainty
Low
3
Limited discussion; no replicates.
Overall Quality Determination
Unacceptable
4.0
Metric mean score**: 3.0.
Extracted

No


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** Consistent with our Application of Systematic Review in TSCARisk Evaluations document, if a metric for a data source receives a score of Unacceptable (score =
4), EPA will determine the study to be unacceptable. In this case, one of the metrics were rated as unacceptable. As such, the study is considered unacceptable
and the score is presented solely to increase transparency,
t High = 1; Medium = 2; Low = 3; Unacceptable = 4; N/A has no value.
$ The overall rating is calculated as necessary. EPA may not always provide a comment for a metric that has been categorized as High.
If any individual metrics are deemed Unacceptable, then the overall rating is also unacceptable. Otherwise, the overall rating is based on the following scale:
High: > 1 to < 1.7; Medium: => 1.7 to < 2.3; Low: => 2.3 to < 3.

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Study Citation: U.S, E. P. A.. 2017. Chemical and product categories: 1-Bromopropane.
Data Type	Databases Not Unique to a Chemical
Hero ID	3970089
Domain
Metric
Rating1
Score
Comments^
Domain 1: Reliability




Metric 1:
Sampling Methodology
High
1
Brief methods described on home page of database, https: //




actor.epa.gov/cpcat/faces/home.xhtml. Further methods de-




scribed in the article "Development of a consumer product




ingredient database for chemical exposure screening and pri-




oritization". Goldsmith M-R, Grulke CM, Brooks RD, et




al. (2013). "Development of a consumer product ingredient




database for chemical exposure screening and prioritization."




Food and Chemical Toxicology 65: 269-279.
Metric 2:
Analytical Methodology
N/A
N/A

Domain 2: Representative




Metric 3:
Geographic Area
High
1
US database.
Metric 4:
Temporal
High
1
Recent products
Metric 5:
Exposure Scenario
High
1

Domain 3: Accessibility/Clarity



Metric 6:
Availability of DB and Supporting Documents
High
1
Widely accepted. Users Guide.
Metric 7:
Reporting Results
High
1
Data is organized. No summary provided, so summary stats




not applicable
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Domain 4: Variability and Uncertainty
Metric 8: Variability and Uncertainty
N/A N/A The study has limited discussion of key uncertainties, limita-
tions, and data gaps. For example, interpreting CPCat cas-
settes. More uncertainties may be available in Goldsmith et
al. 2013. or in Dionisio KL, Frame AM, Goldsmith M-R, et al.
(2015). "Exploring Consumer Exposure Pathways and Pat-
terns of Use for Chemicals in the Environment." Toxicology
Reports 2: 228-237.
Overall Quality Determination
High
1.0
Extracted
No

Continued on next page

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— continued from previous page
Study Citation:
Data Type
Hero ID
U.S, E. P. A.. 2017. Chemical and product categories: 1-Bromopropane.
Databases Not Unique to a Chemical
3970089

Domain
Metric Rating^ Score
Comments^

t High = 1; Medium = 2; Low = 3; Unacceptable = 4; N/A has no value.
$ The overall rating is calculated as necessary. EPA may not always provide a comment for a metric that has been categorized as High.
If any individual metrics are deemed Unacceptable, then the overall rating is also unacceptable. Otherwise, the overall rating is based on the following scale:
High: > 1 to < 1.7; Medium: => 1.7 to < 2.3; Low: => 2.3 to < 3.

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Study Citation: Ntp, Cerhr. 2003. NTP-CERHR monograph on the potential human reproductive and developmental effects of 1-
bromopropane.
Data Type	Completed Exposure Assessment
Hero ID	1519109
Domain Metric
Rating!
Score
Comments^
Domain 1: Reliability
Metric 1: Methodology
High
1

Domain 2: Representative
Metric 2: Exposure Scenario
Low
3
Secondary quantitative data for workers only.
Domain 3: Accessibility/Clarity
Metric 3: Documentation of References
High
1

Domain 4: Variability and LTncertainty
Metric 4: Variability and LTncertainty
High
1

Overall Quality Determination
High
1.5

Extracted
No



1 High = 1; Medium = 2; Low = 3; Unacceptable = 4; N/A has no value.
$ The overall rating is calculated as necessary. EPA may not always provide a comment for a metric that has been categorized as High.
If any individual metrics are deemed Unacceptable, then the overall rating is also unacceptable. Otherwise, the overall rating is based on the following scale:
High: > 1 to < 1.7; Medium: => 1.7 to < 2.3; Low: => 2.3 to < 3.
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Study Citation:	Atsdr,. 2016. Draft toxicological profile forl-bromopropane.
Data Type	Completed Exposure Assessment
Hero ID	3827325
Domain	Metric	Rating! Score	Comments'
Domain 1: Reliability
Metric 1: Methodology
High
1	Govt study, clearly written.
Domain 2: Representative
Metric 2: Exposure Scenario
High
1 Describes consumer and gen pop.
Domain 3: Accessibility/Clarity
Metric 3: Documentation of References
High
1 References provided.
Domain 4: Variability and LTncertainty
Metric 4: Variability and LTncertainty
High
1
Overall Quality Determination
High
1.0
Extracted
No


1 High = 1; Medium = 2; Low = 3; Unacceptable = 4; N/A has no value.
' The overall rating is calculated as necessary. EPA may not always provide a comment for a metric that has been categorized as High.
If any individual metrics are deemed Unacceptable, then the overall rating is also unacceptable. Otherwise, the overall rating is based on the following scale:
High: > 1 to < 1.7; Medium: => 1.7 to < 2.3; Low: => 2.3 to < 3.
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Study Citation:	Japanese Ministry of, Environment. 2017. 1-Bromopropane.
Data Type	Completed Exposure Assessment
Hero ID	3980936
Domain	Metric	Rating^ Score	Comments'
Domain 1: Reliability
Metric 1: Methodology
Low
Assumptions minimally described.
Domain 2: Representative
Metric 2: Exposure Scenario
Low
3
Does not describe metadata regarded ambient air concentra-
tion reported.
Domain 3: Accessibility/Clarity
Metric 3: Documentation of References
Unacceptable
4
No reference provided for the ambient air concentration. Pos-
sibly modeled, but not clear.
Domain 4: Variability and Uncertainty
Metric 4: Variability and Uncertainty
Low
3
Not discussed.
Overall Quality Determination
Unacceptable
4.0
Metric mean score**: 3.2.
Extracted
No



** Consistent with our Application of Systematic Review in TSGARisk Evaluations document, if a metric for a data source receives a score of Unacceptable
(score = 4), EPA will determine the study to be unacceptable. In this case, one of the metrics were rated as unacceptable. As such, the study is considered
unacceptable and the score is presented solely to increase transparency,
t High = 1; Medium = 2; Low = 3; Unacceptable = 4; N/A has no value.
$ The overall rating is calculated as necessary. EPA may not always provide a comment for a metric that has been categorized as High.
If any individual metrics are deemed Unacceptable, then the overall rating is also unacceptable. Otherwise, the overall rating is based on the following scale:
High: > 1 to < 1.7; Medium: => 1.7 to < 2.3; Low: => 2.3 to < 3.

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Study Citation:	Atsdr,. 2016. Toxicological profile for 1-bromopropane.
Data Type	Completed Exposure Assessment
Hero ID	3982334
Domain	Metric	Rating^ Score	Comments'
Domain 1: Reliability
Metric 1: Methodology	Medium 2 Govt report of secondary exposure data. Giving medium since
does not describe lit serch method.
Domain 2: Representative
Metric 2: Exposure Scenario
High
1
Domain 3: Accessibility/Clarity
Metric 3: Documentation of References
High
1
Domain 4: Variability and Uncertainty
Metric 4: Variability and Uncertainty
Medium
2
Overall Quality Determination
High
1.5
Extracted
No


t High = 1; Medium = 2; Low = 3; Unacceptable = 4; N/A has no value.
$ The overall rating is calculated as necessary. EPA may not always provide a comment for a metric that has been categorized as High.
If any individual metrics are deemed Unacceptable, then the overall rating is also unacceptable. Otherwise, the overall rating is based on the following scale:
High: > 1 to < 1.7; Medium: => 1.7 to < 2.3; Low: => 2.3 to < 3.

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Study Citation:	Delmaar, J. E.. Emission of chemical substances from solid matrices: a method for consumer exposure assessment.
Data Type	Completed Exposure Assessment
Hero ID	4663189
Domain	Metric	Rating^ Score	Comments'
Domain 1: Reliability
Metric 1: Methodology
Low
The report discusses the literature review, assumptions, and
limitations of the model. The discussion on data and extrapo-
lations from the model are limited due to data availability and
lack of tested data.
Domain 2: Representative
Metric 2: Exposure Scenario
Low
3
The study models volatile substances using summarized data
and does not specifically model 1-BP. Sample and surrogate
data used may be similar, but the emphasis on building mate-
rials is not in alignment with IBP uses.
Domain 3: Accessibility/Clarity
Metric 3: Documentation of References
Low
3
Numerous studies are referenced, but their use is not always
clear or directly related to the text and/or data.
Domain 4: Variability and Uncertainty
Metric 4: Variability and Uncertainty
Low
3
Variabilities and uncertainties are addressed, but not as they
apply to 1-BP or its specific exposure environments. Models
are built on surrogate paramater values which introduces large
degrees of uncertainty.
Overall Quality Determination
Low
3.0

Extracted
No



t High = 1; Medium = 2; Low = 3; Unacceptable = 4; N/A has no value.
$ The overall rating is calculated as necessary. EPA may not always provide a comment for a metric that has been categorized as High.
If any individual metrics are deemed Unacceptable, then the overall rating is also unacceptable. Otherwise, the overall rating is based on the following scale:
High: > 1 to < 1.7; Medium: => 1.7 to < 2.3; Low: => 2.3 to < 3.
B
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Study Citation:
Data Type
Hero ID
U.S, E. P. A.. 1987. Household solvent products: A national usage survey.
Survey
1005969
Domain
Metric
Rating1
Score
Comments-'"
Domain 1: Reliability
Metric 1:
Metric 2:
Data Collection Methodology
Data. Analysis Methodology
High
High
1
1

Domain 2: Representative
Metric 3:
Metric 4:
Metric 5:
Geographic Area
Sampling / Sampling Size
Response Rate
High
High
Medium
1
1
2
Nationwide (U.S.A.) survey with outreach via random dialing
and willingness to provide address and respond to survey.
Domain 3: Accessibility/Clarity
Metric 6: Reporting of Results
Metric 7: Quality Assurance
High
Medium
1
2

Domain 4: Variability and Uncertainty
Metric 8: Variability and Uncertainty
N/A
N/A
Variability of population studies through survey questions, but
limited discussion of survey uncertainities discussed.
Overall Quality Determination
High
1.3

Extracted

Yes



1 High = 1; Medium = 2; Low = 3; Unacceptable = 4; N/A has no value.
$ The overall rating is calculated as necessary. EPA may not always provide a comment for a metric that has been categorized as High.
If any individual metrics are deemed Unacceptable, then the overall rating is also unacceptable. Otherwise, the overall rating is based on the following scale:
High: > 1 to < 1.7; Medium: => 1.7 to < 2.3; Low: => 2.3 to < 3.
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