Document 9rMD3Mp9znQxbzzOexyOJNN5

$X )ltrO % t Analytical Laboratory RepSotrutdoyn PTritelseence and Concentration of Potassium Perfluorooctanesulfonate in Serum and Liver of Sprague-Dawley Rats Exposed to PFOS via Gavage REPORT AMENDMENT NO. 1 Am1e9nAdpmrieln2t00D0ate: Performing Laboratory 3M Environmental Technology & Safety Services 3M Environmental Laboratory 935 Bush Avenue St. Paul, MN 55106 LaboratEoTry&SPSroLjRecNt-IUd2e0n0t6ification ET&SS FACT Tox-012 3M Environmental Laboratory FACT Tox-012 Report Amendment No. 1 This amendment modifies the following portion(s) of the final report: 1. MFinakaeltRheepfoolrlotw:ing addition to the final report text. AAfdtedr:the final report was issued (signed and archived), it was discovered that the purity value stated for the analytical reference substance was inaccurate. This value was based only on NMR analyses. Subsequent chemical characterization is occurring to determine the actual purity of theses substances (PFOS Lot 193). If necessary, the final report will be amended to detail the analytical results using the purity value from the certificate of analysis when it is issued for PFOS Lot 193. TRoeadsesocnri:be the changes that will be made to the final report when the certificate of analysis is issued for PFOS Lot 193. 2. FMinakaeltRheepfoolrlotw:ing addition to the exceptions list in the Statement of Compliance section. Add: The purity and stability of the analytical reference substance is unknown and was not determined prior to the initiation of this study. TRheeaSstoante:ment of Compliance section was incomplete. 3. TFhineapluRrietypoofrtth:e analytical reference substance is 99.28% (Lot 193), as listed in Table 2. AThmeepnudrittyoorfetahde :analytical reference substance (PFOS Lot 193) listed in Table 2 is unknown. RTheeapsuornit:y value stated for the analytical reference substance is incorrect. 4. MFinakaeltRheepfoollrotw:ing addition to the final report text under circumstances that may affect the quality of the data. Add: According to the Dilution Summary Sheet, the extracts for FO liver samples 8243M , 8244M , 8249M , 8250M , and 8255M were diluted O.OOImL into 1.0mL (1:1000), but were calculated as 1:2000. On the same sheet, the extracts for F0 liver sample 8181M and F1 liver sample 8937 Pup were diluted O.OOImL into LOmL (1:1000), but were calculated as 1:500. The result for 8249M liver sample was quantitated based on peak response that exceeds the highest calibration standard by 20% . TRoeainscolund:e the circumstances that were found after the final report for this study was issued. 3M Environmental Laboratory 0130 FACT Tox-012 Report Amendment No. 1 5. OFinnaplagRee4poofr1t6:, a print error occurred that replaced several lines of the Exceptions to GLP compliance text with an "X" character, without any change in the spacing between the subsequent bullets on the rest of the page. The incorrect page will be replaced in the final report and it will archived in the study folder. AThmeecnodrrteoctrpeaaged:4 of 16 is attached to this amendment. The following list is the complete text lost in the print error: The identity, strength, purity, and composition defining the test or control article was not determined at the time of the study; however, these analyses were performed on the lot of PFOS used subsequent to the present study. Tw o separate study directors were assigned to the in vivo and the analytical portions of this study. From 15 September 1998 until 1 October 1998, the protocol was not sponsor approved and was during that time period not in compliance. Deviations w ere not consistently approved by the study director as required by GLP regulations. Data conections were not always recorded as required by GLP regulations. Data were not always attributed to the individual responsible for recording the data. TRheeafsinoanl:printed report with the incorrect page does not reflect the complete report document as reviewed by the study director and sponsor representative. Amendment Approval Marvin T. 'tC/Vas-te-,v D.V.M., PhD., Sponsor Representative Date Kristen J. Hansen. PhD., Study Director W / I e! j CO Date 3M Environmental Laboratory CC0131 Potassium Perfluorooctanesutfonate C A S Num ber-2759-39-3 3M Environmental Laboratory Report No. Tox-012 Laboratory Request Number (LR N )-U 2006 Sta tem en t of C ompliance Study Title: Analytical Laboratory Report on Presence and Concentration of Potassium Perfluorooctanesulfonate in Serum and Liver of Sprague-Dawley Rats Exposed to P F O S via Gavage Study Identification Number: FA CT Tox-012 This study was conducted in compliance with Food and Drug Administration Good Laboratory Practice (G L P ) Regulations for Nonclinical Laboratory Studies [Data Requirement(s): 21 C FR ( Part 58)], with the exceptions in the bulleted list below. In addition, the present study has been audited retrospectively by an independent quality assurance unit. Audit procedures and findings for audits performed at the 3M Environmental Laboratory and at participating contract laboratories are housed with documentation pertinent to this study in archives at the 3M laboratory and will be retained for at least 10 years. The analytical portion completed at the 3M Environmental Lab was performed in accordance with 3M Environmental Technology and Safety Services Standard Operating Procedures. Exceptions to GLP compliance: Storage containers for the reference substance, PFO S , were not labeled with name, CAS number, batch number, expiration date, or storage conditions. Details of the preparation, maximum storage time, and stability properties of the reference substance, PFOS, are unknown. The identity, strength, purity, and composition defining the test or control article was not determined at the time of the study; however, these analyses were performed on the lot of PFOS used subsequent to the present study. Two separate study directors were assigned to the in vivo and the analytical portions of this study. From 15 September 1998 until 1 October 1998, the protocol was not sponsor approved and was during1that time period not in compliance. Deviations were not consistently approved by the study director as required by GLP regulations. Data corrections were not always recorded as required by GLP regulations. Data w ere not always attributed to the individual responsible for recording the data. Records in electronic form do not meet the criteria set forth under 21 C F R (1 1). A finalized sample log-in /tracking system was not in place at the time of the study; however, draft documents did exist and were used to log in and track samples. Proprietary and Confidential 0C0132 Page 4 of 16