Document QgxRqDKav4g7YaOy0q3bM297L

Report EO1-1245 PFOS: A Reproduction Study with the Nothem Bobwhite Study Title A nalytical Phase Re po r t for PFO S: A R e pr o d u c tio n St u d y w ith T he N o r th e r n Bo b w h ite Data Requirement FI FRA Subdivision E, Section 71-4 O E C D Guideline 206 Author Lisa A. Stevenson Analytical Phase Initiation Date January 3 1 ,2 0 0 2 Analytical Phase Completion Date April 18, 2003 Performing Laboratory 3M Environmental Laboratory Building 2-3E-09 935 Bush Avenue St. Paul, MN 55106 Project Identification 3M Environmental Laboratory Study # E 01-1245 Wildlife International Ltd: 4 54 -1 08 Total Numberof Pages 226 No part of this report should be reproduced, except in full, without written approval of the 3M Environmental Laboratory. 3M Environmental Laboratory Page 1 Cr`0 S 2 8 - Report EOI-1245 Report E01-1245 PFOS: A Reproduction Study with the Nothem Bobwhite PFOS: A Reproduction Study with the Northern Bobwhite GLP Compliance Statement Study Title: Analytical Phase Report for PFOS: A Reproduction Study with The Northern Bobwhite Study Identification Number: E01-1245 This analytical phase was conducted in compliance with Toxic Substances Control Act (TSCA) Good Laboratory Practice (GLP) Standards with the exceptions listed below: Exceptions to GLP compliance: Automated data collection systems are not validated. The hardcopy printouts are considered as the original raw data. The stability of the reference substances and samples has not been determined. Not all data generated were recorded directly or promptly, or initiated and dated on date of entry. Lisa A. Stevenson, Principal Analytical Investigator Susan A. Beach, Sponsor Representative Date 3M Environmental Laboratory 3M Environmental Laboratory Page 2 of 226 Page 2 Report EOI-1245 Report E01-1245 PFOS: A Reproduction Study with the Nothem Bobwhite PFOS: A Reproduction Study with the Northern Bobwhite Q uality Assurance Statement Study Title: Analytical Phase Report for PFOS: A Reproduction Study with The Northern Bobwhite Study Identification Number: E01 -1245 The analytical phase was audited by the 3M Environmental Laboratory Quality Assurance Unit (QAU), as indicated in the following table. The findings were reported to the study director and laboratory management. In s p e c tio n D a te s 10/08/01-10/09/01 02/01/02 04/03/02-04/08/02,04/17/02 05/20/02-05/21/02 P hase P ro to c o l In-phase D ata Final Report D ate R eported to M anagement S tudy D irector 10/09/01 10/09/01 02/04/02 02/04/02 04/08/02,05/16/02 04/00/02,05/16/02 05/21/02 05/21/02 4i Quality Assurance Representative Pittilo? Date 3M Environmental Laboratory 3M Environmental Laboratory Page 3 of 226 Page 3 O'iOMO Report EO1-1245 Report E01-1245 PFOS: A Reproduction Study with the Nothem Bobwhite PFOS: A Reproduction Study with the Northern Bobwhite Table of C ontents GLP Compliance Statement...........................................................................................................................2 Quality Assurance Statement........................................................................................................................ 3 List of Tables.................................................................................................................................................... 5 Study Information.............................................................................................................................................6 Summary........................................................................................................................................................... 7 Purpose............................................................................................................................................................. 8 Reference Substances....................................................................................................................................8 Specimen Receipt and Storage...................................................................................................................... 9 Method Summary............................................................................................................................................. 9 Preparatory Method......................................................................................................................................... 9 Sample Collection and Analysis.....................................................................................................................10 Analytical M ethod............................................................................................................................................. 11 Analytical Results............................................................................................................................................. 12 Data Summary.................................................................................................................................................. 14 Statement of Conclusion................................................................................................................................ 23 Statistical M ethods.......................................................................................................................................... 25 Statement of Data Quality..............................................................................................................................25 R e fe r e n c e s ........................................................................................................................................................26 List of Attachments.......................................................................................................................................... 26 Signature Page................................................................................................................................................. 27 Attachment A: Extraction and Analytical Method, ETS-8-231.1, "Solid Phase Extraction and Analysis of Fluorochemical Compounds from Biological Matrices"........................................................28 Attachment B: Data Summary Tables..........................................................................................................48 Attachment C: Sample Chromatograms, Calibration Information, and Instrument Information......... 62 Attachment D: Sample Preparation Sheets................................................................................................ 155 Attachment E: Study Protocol, Protocol Amendments, and Deviations................................................. 187 Attachment F: Example Calculations...........................................................................................................226 3M Environmental Laboratory 3M Environmental Laboratory Page 4 of 226 Page 4