United States hi Environmental Protection Agency Office of Chemical Safety and Pollution Prevention Final Risk Evaluation for n-Methylpyrrolidone Systematic Review Supplemental File: Data Extraction of Epidemiological Studies CASRN: 872-50-4 December 2020 ------- The table below presents data summaries of epidemiological studies considered in hazard characterization of NMP, as described in Section 3.2 of the Risk Evaluation. Studies that were excluded due to an Unacceptable or Low data quality score are not included. The presented exposure levels are values reported by the study authors and do not represent the PODs used for risk estimation. Page 2 of 4 ------- Target Organ/ System Outcome/ Endpoint Study Population Exposure Results Reference Data Quality Evaluation Hepatic Gamma glutamyl transferase (GGT) expression (in IU/1) was measured in serum as an indication of liver function Cross-sectional, 8 male workers, Switzerland 2006- 2011, ages 22-60 Measured in air and via biomonitoring, daily NMP inhalation exposure median 0.18 mg/m3, urine metabolite biomarkers show NMP/creatinine medians before and after shift: 0.39 mg/g and 0.27 mg/g (5- HNMP), 0.56 mg/g and 1.06 mg/g (2-HMSI) Positive association between NMP and GGT expression, not statistically significant Haufroid et al. 2014 Medium Musculoskeletal/ Motor Function Motor nerve conductivity velocity Cross-sectional, 14 factory workers, Japan 2009, 5 day study Measured in air and via biomonitoring, daily NMP inhalation exposure means of 0.14-0.26 ppm, with maximum exposure of 0.80ppm, urine biomarkers show NMP/creatinine geometric mean of 0.081 mg/g creatinine Positive association with mean conductivity velocity, not statistically significant Nishimura et al. 2009 Medium Neurological/ Behavior Self-rated depression scale Cross-sectional, 14 factory workers, Japan 2009, 5 day study Measured in air and via biomonitoring, daily NMP inhalation exposure means of 0.14-0.26 ppm, with maximum exposure of 0.80ppm, urine biomarkers show NMP/creatinine geometric mean of 0.081 mg/g creatinine Negative association with depression score, statistically significant but stated to not be associated with NMP levels in logistic regression models (data not provided) Nishimura et al. 2009 Medium Page 3 of 4 ------- Target Organ/ System Outcome/ Endpoint Study Population Exposure Results Reference Data Quality Evaluation Renal Serum creatinine (mg/dl) was measured as an indicator of kidney function Cross-sectional, 8 male workers, Switzerland 2006- 2011, ages 22-60 Measured in air and via biomonitoring, daily NMP inhalation exposure median 0.18 mg/m3, urine metabolite biomarkers show NMP/creatinine medians before and after shift: 0.39 mg/g and 0.27 mg/g (5- HNMP), 0.56 mg/g and 1.06 mg/g (2-HMSI) Positive association between NMP and serum creatinine levels, not statistically significant Haufroid et al. 2014 Medium Respiratory Forced expiratory volume in 1st second of spirometry (FEV1) Cross-sectional, 8 male workers, Switzerland 2006- 2011, ages 22-60 Measured in air and via biomonitoring, daily NMP inhalation exposure median 0.18 mg/m3, urine metabolite biomarkers show NMP/creatinine medians before and after shift: 0.39 mg/g and 0.27 mg/g (5- HNMP), 0.56 mg/g and 1.06 mg/g (2-HMSI) Negative association between NMP and FEV1, not statistically significant Haufroid et al. 2014 Medium Haufroid, V; Jaeger, VK; Jeggli, S; Eisenegger, R; Bernard, A; Friedli, D; Lison, D; Hotz, P. (2014). Biological monitoring and health effects of low-level exposure to N-methyl-2-pyrrolidone: A cross-sectional study. Int Arch Occup Environ Health 87(6):663-74. http://dx.doi.org/10.1007/s00420-013-09Q6-5 Nishimura, S; Yasui, H; Miyauchi, H; Kikuchi, Y; Kondo, N; Takebayashi, T; Tanaka, S; Mikoshiba, Y; Omae, K; Nomiyama, T. (2009). A cross- sectional observation of effect of exposure to N-methyl-2-pyrrolidone (NMP) on workers' health. Ind Health 47(4):355-62. http: //dx. doi. org /10.2486/indhealth.47.355 Page 4 of 4 ------- |