PEER REVIEW DRAFT - DO NOT CITE OR QUOTE United States Environmental Protection Agency Office of Chemical Safety and Pollution Prevention Draft Risk Evaluation for 1-Bromopropane (1-BP) 1-BP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. ------- 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 2 6 6 7 7 9 9 10 11 12 13 14 14 B & S < B a o 2 o H O HH H tn O P o c o H tn ------- 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. ------- 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. B & S < B a o 2 o H O HH H tn O P o c o H tn Domain 2: Representativeness Metric 4: Geographic Area High 1 Metric 5: Currency Medium 2 2011-2012 samples Continued on next page ------- — 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. Tl B & S < B a o 2 o H O HH H tn O P o c o H tn ------- 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 B & S < B 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. O o o H O HH H tn O V o c o H tn Domain 4: Variability and Uncertainty Metric 10: Variability and Uncertainty High 1 Continued on next page ------- — 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. ------- 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 Tl B & S < B a o o H O HH H tn O P o c o H tn ** 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. ------- 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 Tl s s < B a o o H O HH H tn O P o c o H tn 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 ------- — 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. ------- 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. Tl B & S < B a o 2 o H O HH H tn O P o c o H tn ------- 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. Tl B & S < B a o 2 o H O HH H tn O P o c o H tn ------- 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. ------- 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. ------- 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 & S < B a o 2 o H O HH H tn O P o c o H tn ------- 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. Tl B & S < B a o 2 o H O HH H tn O P o c o H tn ------- |