Document ID: EPA-HQ-OPPT-2012-0725-0054
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2013-11-14T05:00Z

PBPK Package Supporting NMP Risk Assessment
                            Name of folder or file
                                  Description
                             NMP_human_9-16-13.zip
This zip file contains the files needed to run the human PBPK model, including the exposure data and plots.
                             NMP_rat_9-16-2013.zip
This zip file contains the files needed to run the rat PBPK model, including the exposure data and plots.
              NMP PBPK Model Quality Assurance Assessment Report
               n-Methylpyrrolidone PBPK QA Report 091613 V3.docx
This Word document contains the model code evaluation that EPA conducted to the revised PBPK model that Dr. Torka Poet submitted to the Agency in March 2013.
              Residential_PBPK results and risk estimates_091513
This Excel spreadsheet contains the AUC and Cmax values for the NMP's residential scenarios examined in the risk assessment.  In addition, it contains information about the benchmark dose metrics and toxic endpoints used in the assessment and preliminary risk estimates (Margin of Exposures or MOEs).
               Workplace_PBPK results and risk estimates_091213
This Excel spreadsheet contains the AUC and Cmax values for the NMP's workplace scenarios examined in the risk assessment.  In addition, it contains information about the benchmark dose metrics and toxic endpoints used in the assessment and preliminary risk estimates (Margin of Exposures or MOEs).
                   NMP dose-response analysis_091613 v3.docx
This files documents the dose-response analysis for NMP, particularly the pooled analysis using Saillenfait et al.(2003) and Becci et al.. 1982.
                               BMC calculations
                   BMD Analysis_Becci 1982_Cmax_090513.docx
          BMD Analysis_Pooled Becci Saillenfait data_Cmax_090513.docx
                 BMD Analysis_Saillenfait 2003_AUC_091513.docx
                BMD Analysis_Saillenfait 2003_Cmax_091513.docx
BMD calculations using the data from Becci et al. 1982 and Saillenfait et al. 2003.
                                       
                            Becci et al. 1982.pdf 
Paper entitled "Teratogenicity study of N-methylpyrrolidone after dermal application to Sprague-Dawley rats"; Fundamental and Applied Toxicology (1982) 2: 73-76 (copyrighted paper)

                          Saillenfait et al. 2003.pdf
Paper entitled "Developmental toxicity of N-methyl-2-pyrrolidone in rats following inhalation exposure"; Food and Chemical Toxicology (2003) 41: 583-588 (copyrighted paper)

                            Ligocka et al. 2003.pdf
Paper entitled "Contribution of CYP2E1 to N-methyl-2-pyrrolidone metabolism"; Arch Toxicol (2003) 77: 261 - 266 (copyrighted paper)

Paper supports retaining a 10X factor for inter-individual differences