PEER REVIEW DRAFT - DO NOT CITE OR QUOTE >=,EPA United States Office of Chemical Safety and Environmental Protection Agency Pollution Prevention Risk Evaluation for N-Methylpyrrolidone Systematic Review Supplemental File: Data Quality Evaluation of Consumer and General Population Exposure Data Sources CASRN: 872-50-4 October 2019 1 ------- PEER REVIEW DRAFT - DO NOT CITE OR QUOTE Monitoring Study Citation: Kiefer, M.. 1994.0. Health Hazard Evaluation Report No. HETA-93-0844-2411, Rosebud Company, Atlanta, Georgia. Data Type Monitoring Hero ID 3836708 Domain Metric Rating^ Score Comments Domain 1: Reliability Metric 1: Sampling Methodology Medium Metric 2: Analytical Methodology Low Metric 3: Biomarker Selection N/A 2 provided amount of product applied, square footage of floor covered, percent ai in product, application description, nom- inal air flow rate, sampling duration, activity monitored. No discussion of storage conditions and duration. 3 OSHA Stop-gap method M139, no description of method pro- vided. No discussion of laboratory controls, calibrations, op- erating conditions. N/A No Comment. Domain 2: Representativeness Metric 4: Metric 5: Metric 6: Metric 7: Geographic Area High 1 Currency Low 3 Spatial and Temporal Variability Low 3 Exposure Scenario Low 3 No Comment. 1993.0 Only 2 trials. Use of paint stripper on floor, not sure if a consumer would use an electric buffer and sawdust? Domain 3: Accessibility/Clarity Metric 8: Reporting of Results Metric 9: Quality Assurance Medium Low 2 3 no raw data reports. No discussion of breakthrough results for sampling train. Field blanks used. No results of recoveries, blanks, correction if needed, etc. Domain 4: Variability and Uncertainty Metric 10: Variability and Uncertainty Low 3 little discussion of uncertainty. Overall Quality Determination Low 2.6 Extracted Yes r High = 3; Medium = 2; Low = 1; Unacceptable = 4; N/A has no value. 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 < 2.4; Low => 2.4 to < 3. ------- PEER REVIEW DRAFT - DO NOT CITE OR QUOTE 2 Experimental Study Citation: M. Nohr, W. Horn, O. Jann, M. Richter, W. Lorenz. 2015.0. Development of a multi-VOC reference material for quality assurance in materials emission testing. Analytical and Bioanalytical Chemistry. Data Type Experimental Hero ID 2718034 Domain Metric Ratingt Score Comments Domain 1: Reliability Metric 1: Metric 2: Metric 3: Sampling Methodology and Conditions Analytical Methodology Biomarker Selection Medium Low N/A 2 3 N/A Development of new method, micro chamber. No LOQ provided in article. Method described elsewhere. No Comment. Domain 2: Representative Metric 4: Metric 5: Metric 6: Testing Scenario Sample Size and Variability Temporality Medium Low High 2 3 1 The emissions is from volatility in a petri dish. The product was not "applied". Three batches of same product. No Comment. Domain 3: Accessibility/Clarity Metric 7: Reporting of Results Metric 8: Quality Assurance Medium N/A 2 N/A No raw data, not discussed. Domain 4: Variability and Uncertainty Metric 9: Variability and Uncertainty High 1 RSD provided, discussed influence on humidity, chamber flow. Overall Quality Determination Medium 2.0 Extracted Yes 1 High = 3; Medium = 2; Low = 1; Unacceptable = 4; N/A has no value. 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 < 2.4; Low => 2.4 to < 3. 3 ------- PEER REVIEW DRAFT - DO NOT CITE OR QUOTE Study Citation: Wolkoff, P.. 1998.0. Impact of air velocity, temperature, humidity, and air on long-term VOC emissions from building products. Atmospheric Environment. Data Type Experimental Hero ID 3005854 Domain Metric Rating^" Score Comments Domain 1: Reliability Metric 1 Metric 2 Metric 3 Sampling Methodology and Conditions Analytical Methodology Biomarker Selection High High N/A 1 1 N/A No Comment. No Comment. No Comment. Domain 2: Representative Metric 4 Metric 5 Metric 6 Testing Scenario Sample Size and Variability Temporality Medium Unacceptable Low 2 4 3 indoor air study, but consumer products are not clarified, sample size is not reported. > 15 years old Domain 3: Accessibility/Clarity Metric 7: Reporting of Results Metric 8: Quality Assurance Unacceptable N/A 4 N/A no results for NMP. discussed spiked samples, but only limited QC is discussed. Domain 4: Variability and Uncertainty Metric 9: Variability and Uncertainty Medium 2 discussed influence of temperature and other parameters. Overall Quality Determination Unacceptable 4.0 Metric mean score**: 2.4. Extracted No ** 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, two 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 = 3; Medium = 2; Low = 1; Unacceptable = 4; N/A has no value. 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 < 2.4; Low => 2.4 to < 3. 4 ------- PEER REVIEW DRAFT - DO NOT CITE OR QUOTE Study Citation: Bader, M.,Keener, S. A.,Wrbitzky, R.. 2005.0. Dermal absorption and urinary elimination of N-methyl-2-pyrrolidone. Inter- national Archives of Occupational and Environmental Health. Data Type Experimental Hero ID 3539719 Domain Metric Ratingt Score Comments Domain 1: Reliability Metric 1: Sampling Methodology and Conditions Medium 2 no standard methodology mentioned, but detailed methodol- ogy provided. Metric 2: Analytical Methodology High 1 NMP in urine was analysed according to A " kesson and Pauls- son (1997a, b).. LOQ provided. Metric 3: Biomarker Selection N/A N/A The analyzed NMP in urine, but not for the purpose of expo- sure to a consumer product, but to look at dermal absorption, Domain 2: Representative Metric 4: Testing Scenario Medium 2 The pure chemical was tested, not a product. Metric 5: Sample Size and Variability Medium 2 7 volunteers. Metric 6: Temporality High 1 2005 study, but since experimental time is not critical. Domain 3: Accessibility/Clarity Metric 7: Reporting of Results Medium 2 no raw data Metric 8: Quality Assurance N/A N/A QC not discussed. Domain 4: Variability and Uncertainty Metric 9: Variability and Uncertainty Low 3 No Comment. Overall Quality Determination Medium 1.9 Extracted No f High = 3; Medium = 2; Low = 1; Unacceptable = 4; N/A has no value. 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 < 2.4; Low => 2.4 to < 3. 5 ------- PEER REVIEW DRAFT - DO NOT CITE OR QUOTE Study Citation: Keener, S. A.,Wrbitzky, R.,Bader, M.. 2007.0. Human volunteer study on the influence of exposure duration and dilution of dermally applied N-methyl-2-pyrrolidone (NMP) on the urinary elimination of NMP metabolites. International Archives of Occupational and Environmental Health. Data Type Experimental Hero ID 3539848 Domain Metric Rating^ Score Comments Domain 1: Reliability Metric 1: Sampling Methodology and Conditions High 1 Application of product to hand described in described by Bader et al. (2005a).. The samples were stored at 28"C before anal- ysis. Analysed as described by J" nsson and " kesson (1997). GC/MS. Calibration standards were prepared from a blank urine pool. The parameters 5-HNMP, 2-HMSI and creatinine in urine were certified within round-robins of the German External Quality Assurance Scheme No Comment. Metric 2: Metric 3: Analytical Methodology Biomarker Selection High High 1 1 Domain 2: Representative Metric 4: Metric 5: Metric 6: Testing Scenario Sample Size and Variability Temporality Medium Low High 2 3 1 Consumer product not applied. Multiple testing scenarios were conducted however (different concentrations). Only 4 volunteers. 2007, but temporality not as relevant due to study design. Domain 3: Accessibility/Clarity Metric 7: Reporting of Results Metric 8: Quality Assurance Medium N/A 2 N/A no raw data use of blanks, corrections for recovery rate of NMP in urine (65 percent) Domain 4: Variability and Uncertainty Metric 9: Variability and Uncertainty Medium 2 No Comment. Overall Quality Determination High 1.6 Extracted No 1 High = 3; Medium = 2; Low = 1; Unacceptable = 4; N/A has no value. 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 < 2.4; Low => 2.4 to < 3. 6 ------- PEER REVIEW DRAFT - DO NOT CITE OR QUOTE Study Citation: Ursin, C.,Hansen, C. M.,Van Dyk, J. W.,Jensen, P. 0.,Christensen, I. J.,Ebbehoej, J.. 1995.0. Permeability of commercial solvents through living human skin. American Industrial Hygiene Association Journal. Data Type Experimental Hero ID 3540771 Domain Metric Ratingt Score Comments Domain 1: Reliability Metric 1 Metric 2 Metric 3 Sampling Methodology and Conditions Analytical Methodology Biomarker Selection High Low N/A 1 3 N/A No standard method mentioned, but sapling well described. GC method; no details provided. No Comment. Domain 2: Representative Metric 4 Metric 5 Metric 6 Testing Scenario Sample Size and Variability Temporality Medium Low High 2 3 1 permeability of the solvent, not a consumer product, appears to be <5 samples 1995 study, but temporality is not key to a lab study. Domain 3: Accessibility/Clarity Metric 7: Reporting of Results Metric 8: Quality Assurance Medium N/A 2 N/A No raw data limited discussion Domain 4: Variability and Uncertainty Metric 9: Variability and Uncertainty Medium 2 No Comment. Overall Quality Determination Medium 2.0 Extracted No t High = 3; Medium = 2; Low = 1; Unacceptable = 4; N/A has no value. 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 < 2.4; Low => 2.4 to < 3. 7 ------- PEER REVIEW DRAFT - DO NOT CITE OR QUOTE Study Citation: U.S, E. P. A.. 1994.0. Consumer exposure to paint stripper solvents. Data Type Experimental Hero ID 3808963 Domain Metric Rating^ Score Comments Domain 1: Reliability Metric 1: Metric 2: Metric 3: Sampling Methodology and Conditions Analytical Methodology Biomarker Selection High Medium N/A 1 2 N/A Test protocol was provided. Each of the selected products was tested in triplicate under controlled environmental conditions inside MAl's Air Consumer Exposure (ACE) Laboratory expo- sure chamber for a total of 15 experiments. The paint strippers were used according to the manufacturers' instructions printed on the label. The application procedure was consistent with previous laboratory studies conducted at the Lawrence Berke- ley Laboratory (Girman and Hodgson, 1986). All pertinent sampling information is provided: test chamber preparation, sampling equipment, test conditions, etc. D. Details of the analytical method were provided in Appendix C. NMP samples were analyzed using a method developed by GAF and partially validated by OSHA.. GAF/OSHA. Gas Chromatography (GC) equipped with FID Biomarker is not used. Domain 2: Representative Metric 4: Metric 5: Metric 6: Testing Scenario Sample Size and Variability Temporality High Medium Low 1 2 3 Testing conditions closely represent relevant exposure scenar- ios. The objective of this study is to determine consumer ex- posure to solvents contained in commercially available paint strippers under typical product-use scenarios. Moderate sample size. For Wood Finisher's Pride (the product that contained NMP) three test runs were conducted; six sam- ples were collected during each test run: pretest background, test chamber (center, inlet side, and outlet side), breathing zone, and supply to test chamber. >15 years; Report date 1994 Domain 3: Accessibility/Clarity Metric 7: Reporting of Results Metric 8: Quality Assurance Medium N/A 2 N/A Test Results for Integrated Air Sampling for Wood Finisher's Pride (NMP product) reported in Table 9. Blind spikes samples were prepared at MAI and submitted to DataChem Laboratories, Inc. with the regular air sampling media. The blind spikes were prepared by injecting a known volume of each of the target analytes onto the appropriate sor- bent tube with a microliter syringe. Domain 4: Variability and Uncertainty Metric 9: Variability and Uncertainty Medium 2 key uncertainties, limitations, and data gaps are not discussed. Continued on next page 8 ------- PEER REVIEW DRAFT - DO NOT CITE OR QUOTE — continued from previous page Study Citation: Data Type Hero ID U.S, E. P. A.. 1994.0. Consumer exposure to paint stripper solvents. Experimental 3808963 Domain Metric Ratingt Score Comments Overall Quality Determination Medium 1.9 Extracted No t High = 3; Medium = 2; Low = 1; Unacceptable = 4; N/A has no value. 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 < 2.4; Low => 2.4 to < 3. 9 ------- PEER REVIEW DRAFT - DO NOT CITE OR QUOTE Study Citation: UL Env. 2017.0. Floor Coating VOC Emissions Research Report. Data Type Experimental Hero ID 4440489 Domain Metric Rating^ Score Comments Domain 1: Reliability Metric 1 Metric 2 Metric 3 Sampling Methodology and Conditions Analytical Methodology Biomarker Selection Medium Medium N/A 2 2 N/A No Comment. No Comment. No Comment. Domain 2: Representative Metric 4 Metric 5 Metric 6 Testing Scenario Sample Size and Variability Temporality High Medium Medium 1 2 2 No Comment. No Comment. No Comment. Domain 3: Accessibility/Clarity Metric 7: Reporting of Results Metric 8: Quality Assurance Medium N/A 2 N/A No Comment. No Comment. Domain 4: Variability and Uncertainty Metric 9: Variability and Uncertainty Medium 2 No Comment. Overall Quality Determination Medium 1.9 Extracted Yes t High = 3; Medium = 2; Low = 1; Unacceptable = 4; N/A has no value. 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 < 2.4; Low => 2.4 to < 3. 10 ------- PEER REVIEW DRAFT - DO NOT CITE OR QUOTE Study Citation: Delmaar, J. E.. nan. Emission of chemical substances from solid matrices: a method for consumer exposure assessment. Data Type Experimental Hero ID 4663189 Domain Metric Haling1 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 secondary review article with experimental data cited in sup- port of modeling approach. secondary review article with experimental data cited in sup- port of modeling approach. No Comment. Domain 2: Representative Metric 4: Metric 5: Metric 6: Testing Scenario Sample Size and Variability Temporality Low Low Low 3 3 3 approach requires equilibrium assumption for article exposure, not all chemicals have article scenarios. No Comment. point in time estimate for approaches based on regressions and measured data available to date. Domain 3: Accessibility/Clarity Metric 7: Reporting of Results Metric 8: Quality Assurance Low N/A 3 N/A No Comment. No Comment. Domain 4: Variability and Uncertainty Metric 9: Variability and Uncertainty Low 3 No Comment. Overall Quality Determination Low 3.0 Extracted No t High = 3; Medium = 2; Low = 1; Unacceptable = 4; N/A has no value. 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 < 2.4; Low => 2.4 to < 3. 11 ------- PEER REVIEW DRAFT - DO NOT CITE OR QUOTE Study Citation: A. T. Hodgson. 2001.0. Predicted concentrations in new relocatable classrooms of volatile organic compounds emitted from standard and alternate interior finish materials. Data Type Experimental Hero ID 4683360 Domain Metric Ratingt Score Comments Domain 1: Reliability Metric 1: Metric 2: Metric 3: Sampling Methodology and Conditions Analytical Methodology Biomarker Selection High High N/A 1 1 N/A No Comment. No Comment, no biomarkers Domain 2: Representative Metric 4: Testing Scenario Medium 2 kind of products, test substance, testing methods are de- scribed. But exposure control is not discussed, and temper- ature/pressure are assumed value for estimation of concentra- tion. 2-4 products samples per product type. >15 yrs old Metric 5: Metric 6: Sample Size and Variability Temporality Low Low 3 3 Domain 3: Accessibility/Clarity Metric 7: Reporting of Results Metric 8: Quality Assurance Medium N/A 2 N/A Each results are summarized in each tables. The value in each tables are not raw data though, raw values of concentration are possibly calculated by equation(l). Statistical discussion is missed. QC discussion is quite limited. Domain 4: Variability and Uncertainty Metric 9: Variability and Uncertainty Low 3 Variability/Uncertainty discussion is quite limited. Overall Quality Determination Medium 2.1 Extracted Yes 1 High = 3; Medium = 2; Low = 1; Unacceptable = 4; N/A has no value. 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 < 2.4; Low => 2.4 to < 3. 12 ------- PEER REVIEW DRAFT - DO NOT CITE OR QUOTE Study Citation: DTI. 2004.0. Survey of chemical substance in consumer products. Data Type Experimental Hero ID 5035312 Domain Metric Rating^ Score Comments Domain 1: Reliability Metric 1; Sampling Methodology and Conditions Low 3 Small number of samples (10); not clear if replicate samples used Metric 2: Analytical Methodology High 1 No Comment. Metric 3: Biomarker Selection High 1 No Comment. Domain 2: Representative Metric 4: Testing Scenario Metric 5: Sample Size and Variability Metric 6: Temporality High Medium N/A 1 2 N/A No Comment. Sample size is low (10) No Comment. Domain 3: Accessibility/Clarity Metric 7: Reporting of Results Metric 8: Quality Assurance High N/A 1 N/A No Comment. No Comment. Domain 4: Variability and Uncertainty Metric 9: Variability and Uncertainty Medium 2 Greater number of samples and replicate samples could reduce uncertainty Overall Quality Determination High 1.6 Extracted No t High = 3; Medium = 2; Low = 1; Unacceptable = 4; N/A has no value. 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 < 2.4; Low => 2.4 to < 3. 13 ------- PEER REVIEW DRAFT - DO NOT CITE OR QUOTE Databases Not Unique to a Chemical Study Citation: U.S, E. P. A.. 2017.0. STORET: N-methylpyrrolidone. Data Type Databases Not Unique to a Chemical Hero ID 3970048 Domain Metric l lal iT i g Score Comments Domain 1: Reliability Metric 1: Metric 2: Sampling Methodology Analytical Methodology High High 1 1 No Comment. No Comment. Domain 2: Representative Metric 3: Metric 4: Metric 5: Geographic Area Temporal Exposure Scenario High High High 1 1 1 No Comment. No Comment. No Comment. Domain 3: Accessibility/Clarity Metric 6: Availability of DB and Supporting Documents Metric 7: Reporting Results High High 1 1 No Comment. No Comment. Domain 4: Variability and Uncertainty Metric 8: Variability and Uncertainty N/A N/A No Comment. Overall Quality Determination High 1.0 Extracted No t High = 3; Medium = 2; Low = 1; Unacceptable = 4; N/A has no value. 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 < 2.4; Low => 2.4 to < 3. 14 ------- PEER REVIEW DRAFT - DO NOT CITE OR QUOTE Study Citation: Consumer Product Information, Database. 2017.0. What's in it? n-methylpyrrolidone. Data Type Databases Not Unique to a Chemical Hero ID 3981162 Domain Metric Rating^ Score Comments Domain 1: Reliability Metric 1: Metric 2: Sampling Methodology Analytical Methodology Low N/A 3 N/A Webpage provides only very limited info. Brands selected based on market share. No Comment. Domain 2: Representative Metric 3: Metric 4: Metric 5: Geographic Area Temporal Exposure Scenario High High High 1 1 1 USA and Canada database "Date verified" provided, some <5 yrs old. Weight fractions of consumer products. Domain 3: Accessibility/Clarity Metric 6: Availability of DB and Supporting Documents Metric 7: Reporting Results Low High 3 1 No info how data collected or QC provided. Data is organized. No summary provided, so summary stats not applicable Domain 4: Variability and Uncertainty Metric 8: Variability and Uncertainty N/A N/A Based on industry reported weight fraction (e.g., MSDS); not measured data Overall Quality Determination Medium 1.7 Extracted No t High = 3; Medium = 2; Low = 1; Unacceptable = 4; N/A has no value. 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 < 2.4; Low => 2.4 to < 3. 15 ------- PEER REVIEW DRAFT - DO NOT CITE OR QUOTE Study Citation: Bartzis, J.. 2018.0. Prioritization of building materials as indoor pollution sources (BUMA). Data Type Databases Not Unique to a Chemical Hero ID 4663145 Domain Metric Rating^ Score Comments Domain 1: Reliability Metric 1: Sampling Methodology N/A N/A Sampling method not discussed - secondary source of info. Metric 2: Analytical Methodology N/A N/A Analytical method not discussed - secondary source of info. Domain 2: Representative Metric 3: Geographic Area Metric 4: Temporal Metric 5: Exposure Scenario High Medium Medium 1 2 2 No Comment. Data of various ages. Not an exact match except for NMP Domain 3: Accessibility/Clarity Metric 6: Availability of DB and Supporting Documents Metric 7: Reporting Results High High 1 1 No Comment. References listed. Emission rates were from fits to concentra- tion data. Domain 4: Variability and Uncertainty Metric 8: Variability and Uncertainty N/A N/A No Comment. Overall Quality Determination High 1.4 Extracted Yes t High = 3; Medium = 2; Low = 1; Unacceptable = 4; N/A has no value. 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 < 2.4; Low => 2.4 to < 3. 16 ------- PEER REVIEW DRAFT - DO NOT CITE OR QUOTE Completed Exposure Assessments Study Citation: Rivm,. 2013.0. Annex XV Restriction Report: Proposal for a Data Type Completed Exposure Assessment Hero ID 3809440 Restriction. Domain Metric Rating^ Score Comments Domain 1: Reliability Metric 1: Methodology Medium 2 lit search or data collection methods are not described. Domain 2: Representative Metric 2: Exposure Scenario Medium 2 scenario interest, relatively new study.(within 5 yrs) but not the US. Domain 3: Accessibility/Clarity Metric 3: Documentation of References High 1 No Comment. Domain 4: Variability and Uncertainty Metric 4: Variability and Uncertainty Low 3 variability/uncertainty is not discussed well. Overall Quality Determination Medium 2.0 Extracted No t High = 3; Medium = 2; Low = 1; Unacceptable = 4; N/A has no value. 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 < 2.4; Low => 2.4 to < 3. 17 ------- PEER REVIEW DRAFT - DO NOT CITE OR QUOTE Study Citation: Who,. 2001.0. Concise International Chemical Assessment Document 35: N-Methyl-2-Pyrrolidone. Data Type Completed Exposure Assessment Hero ID 3809476 Domain Metric Rating^ Score Comments Domain 1: Reliability Metric 1: Methodology Medium 2 No discussion of lit search techniques Domain 2: Representative Metric 2: Exposure Scenario High 1 No Comment. Domain 3: Accessibility/Clarity Metric 3: Documentation of References High 1 waste water effluent Domain 4: Variability and Uncertainty Metric 4: Variability and Uncertainty Low 3 No Comment. Overall Quality Determination Medium 1.8 Extracted No t High = 3; Medium = 2; Low = 1; Unacceptable = 4; N/A has no value. 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 < 2.4; Low => 2.4 to < 3. 18 ------- PEER REVIEW DRAFT - DO NOT CITE OR QUOTE Study Citation: Danish EPA. 2015.0. List of Undesirable Substances (LOUS): Survey of l-methyl-2-pyrrolidone. Data Type Completed Exposure Assessment Hero ID 3827507 Domain Metric Rating^ Score Comments Domain 1: Reliability Metric 1: Methodology Medium 2 No Comment. Domain 2: Representative Metric 2: Exposure Scenario High 1 No Comment. Domain 3: Accessibility/Clarity Metric 3: Documentation of References High 1 No Comment. Domain 4: Variability and Uncertainty Metric 4: Variability and Uncertainty Medium 2 No Comment. Overall Quality Determination High 1.5 Extracted No t High = 3; Medium = 2; Low = 1; Unacceptable = 4; N/A has no value. 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 < 2.4; Low => 2.4 to < 3. 19 ------- PEER REVIEW DRAFT - DO NOT CITE OR QUOTE Study Citation: Echa,. 2014.0. Background document to the opinion on the annex XV dossier proposing restrictions on l-methyl-2-pyrrolidone (NMP). Data Type Completed Exposure Assessment Hero ID 3827511 Domain Metric Ratingt Score Comments Domain 1: Reliability Metric 1: Methodology High 1 No Comment. Domain 2: Representative Metric 2: Exposure Scenario High 1 No Comment. Domain 3: Accessibility/Clarity Metric 3: Documentation of References High 1 No Comment. Domain 4: Variability and Uncertainty Metric 4: Variability and Uncertainty High 1 No Comment. Overall Quality Determination High 1.0 Extracted No t High = 3; Medium = 2; Low = 1; Unacceptable = 4; N/A has no value. 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 < 2.4; Low => 2.4 to < 3. 20 ------- PEER REVIEW DRAFT - DO NOT CITE OR QUOTE Study Citation: Australian Government Department of, Health. 2016.0. Human health tier III assessment for l-methyl-2-pyrrolidinone. Data Type Completed Exposure Assessment Hero ID 3969286 Domain Metric Rating^ Score Comments Domain 1: Reliability Metric 1: Methodology High 1 No Comment. Domain 2: Representative Metric 2: Exposure Scenario Medium 2 in Australia. Domain 3: Accessibility/Clarity Metric 3: Documentation of References High 1 No Comment. Domain 4: Variability and Uncertainty Metric 4: Variability and Uncertainty Medium 2 multiple weight fractions are discussed though, variability/ uncertainty is not described clearly. Overall Quality Determination High 1.5 Extracted Yes t High = 3; Medium = 2; Low = 1; Unacceptable = 4; N/A has no value. 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 < 2.4; Low => 2.4 to < 3. 21 ------- PEER REVIEW DRAFT - DO NOT CITE OR QUOTE Study Citation: Environment, Canada. 2017.0. Draft screening assessment: 2-Pyrrolidinone, 1-methylO (NMP) and 2-Pyrrolidinone, 1-ethyl (NEP). Data Type Completed Exposure Assessment Hero ID 3969287 Domain Metric Ratingt Score Comments Domain 1: Reliability Metric 1: Methodology High 1 No Comment. Domain 2: Representative Metric 2: Exposure Scenario High 1 No Comment. Domain 3: Accessibility/Clarity Metric 3: Documentation of References High 1 No Comment. Domain 4: Variability and Uncertainty Metric 4: Variability and Uncertainty Low 3 No Comment. Overall Quality Determination High 1.5 Extracted No t High = 3; Medium = 2; Low = 1; Unacceptable = 4; N/A has no value. 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 < 2.4; Low => 2.4 to < 3. 22 ------- PEER REVIEW DRAFT - DO NOT CITE OR QUOTE Study Citation: H. Willem, B. Singer. 2010.0. Chemical emissions of residential materials and products: Review of available information. Data Type Completed Exposure Assessment Hero ID 4683373 Domain Metric Rating^ Score Comments Domain 1: Reliability Metric 1: Methodology High 1 No Comment. Domain 2: Representative Metric 2: Exposure Scenario Low 3 US report, but a bit old report(> 5yrs) and no chemicals in- terest. Domain 3: Accessibility/Clarity Metric 3: Documentation of References High 1 No Comment. Domain 4: Variability and Uncertainty Metric 4: Variability and Uncertainty High 1 No Comment. Overall Quality Determination High 1.5 Extracted No t High = 3; Medium = 2; Low = 1; Unacceptable = 4; N/A has no value. 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 < 2.4; Low => 2.4 to < 3. 23 ------- PEER REVIEW DRAFT - DO NOT CITE OR QUOTE Survey Study Citation: U.S, E. P. A.. 1987.0. Household solvent products: A national usage survey. Data Type Survey Hero ID 1005969 Domain Metric Rating^ Score Comments Domain 1: Reliability Metric 1: Data Collection Methodology High 1 No Comment. Metric 2: Data Analysis Methodology High 1 No Comment. Domain 2: Representative Metric 3: Geographic Area High 1 Nationwide (U.S.A.) survey with outreach via random dialing and willingness to provide address and respond to survey. Metric 4: Sampling / Sampling Size High 1 No Comment. Metric 5: Response Rate Medium 2 No Comment. Domain 3: Accessibility/Clarity Metric 6: Reporting of Results High 1 No Comment. Metric 7: Quality Assurance Medium 2 No Comment. Domain 4: Variability and Uncertainty Metric 8: Variability and Uncertainty N/A N/A No Comment. Overall Quality Determination High 1.3 Extracted Yes t High = 3; Medium = 2; Low = 1; Unacceptable = 4; N/A has no value. 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 < 2.4; Low => 2.4 to < 3. 24 ------- PEER REVIEW DRAFT - DO NOT CITE OR QUOTE Study Citation: Abt. 1992.0. Methylene chloride consumer use study survey findings. Data Type Survey Hero ID 1065590 Domain Metric Rating^ Score Comments Domain 1: Reliability Metric 1: Metric 2: Data Collection Methodology Data Analysis Methodology Medium Medium 2 2 Data collection instrument was described. The protocols for field personnel was not. Weighted summary stats provided, and unweighted counts pro- vided in appendix. Could not find a discussion on sampling and non sampling errors. Domain 2: Representative Metric 3: Metric 4: Metric 5: Geographic Area Sampling / Sampling Size Response Rate High High Medium 1 1 2 No Comment. No Comment. for the questionaire, response rate was about 40 percent. Domain 3: Accessibility/Clarity Metric 6: Reporting of Results Metric 7: Quality Assurance High Low 1 3 No Comment. No discussion of QC Domain 4: Variability and Uncertainty Metric 8: Variability and Uncertainty N/A N/A limited discussion Overall Quality Determination Medium 1.7 Extracted Yes t High = 3; Medium = 2; Low = 1; Unacceptable = 4; N/A has no value. 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 < 2.4; Low => 2.4 to < 3. 25 ------- PEER REVIEW DRAFT - DO NOT CITE OR QUOTE 6 Modeling Study Citation: UL Env. 2017.0. Floor Coating VOC Emissions Research Report. Data Type Modeling Hero ID 4440489 Domain Metric Rating^ Score Comments Domain 1: Reliability Metric 1: Metric 2: Mathematicl Equations Model Evaluation Medium Medium 2 2 Emission rates of TVOC were used in a computer model tode- termine potential air concentrations of the pollutants. The computer model used the measured emission rate changes over the one-week time period to determine the change in air con- centrations that would accordingly occur. The emission factor can be modeled according to a first-order decay. The emission rates calculated from these samples were used in a mathematical model to predict the concentration that would occur in an office environment. The model parameters were 11.1 m2 of flooring in a 30.6 m3 room with an outdoor air change rate of 0.68/hr. Domain 2: Representative Metric 3: Exposure Scenario High 1 <5 years (2017 pub date) Table 5 reports predicted concentra- tions of NMP from time of application to one week for floor coatings W7 and W3 (floor loading in office) Domain 3: Accessibility/Clarity Metric 4: Model and Model Documentation Availability Metric 5: Model Inputs and Defaults High Medium 1 2 There is sufficient documentation in the data source Data quality acceptance criteria are not discussed but inputs appear appropriate. The emission factor can be modeled ac- cording to a first-order decay: EFm = EF0 e-kt where, EFm = modeled emission factor ("g/m"hr) or ("g/unit"hr) EF0 = initial emission factor ("g/m"hr) or ("g/unit"hr) k = rate con- stant (hr-1) t = time (hr) Domain 4: Variability and Uncertainty Metric 6: Variability and Uncertainty Low 3 No Comment. Overall Quality Determination Medium 1.8 Extracted Yes t High = 3; Medium = 2; Low = 1; Unacceptable = 4; N/A has no value. 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 < 2.4; Low => 2.4 to < 3. 26 ------- |