Document ByyGj1264RjEjyaGmNZNJqM6k
A R 1 U -0 1 5 I
Laboratory Report
Interim Report of Preliminary Data for 26 Week Capsule Toxicology Study with PFOS in Cynomolgus Monkeys
Laboratory Report No. FACT-TOX-030
Covance 6329-223
Testing Laboratory
3M Environmental Technology & Safety Services 3M Environmental Laboratory
Fluorine Analytical Chemistry Team (FACT) 2-3E-09
935 Bush Avenue, St. Paul, M N 55106
Laboratory Contact
Kris Hansen, Ph.D. Bldg. 2-3E-09 P.O.Box 3331
St. Paul, M N 55133-3331 Phone: (651)778-6018 FAX: (651)778-7176
Requester
Andrew Seacat and Marv Case 3M Company
Toxicology Services 220-2E-02 St. Paul, M N 003677
PAGE 10F 5
3MENVIRREOPNOMRETNNTOA.LFLAACBTO-TROAXTO-0R3Y0
1 Introduction
eTfhfeisctsstuodbysewrvaesddiensiCgnyendomtooelsgtuasbmlisohnakPeyFsO. TSedsiteatanriymianl-stawkeerleedvoelseadt wdahiilcyhbtyheorrealagreavnaogoebwseirthvavbalreioaudsverse aa2nm6i-mowuaenlestk.s osStfuePdraFyO.saSSmeipnralelsasacwmtoepsreleewscocitlohlelilcnetceatdegdferlfoarmotimnacltalhpteessautnleaim.niTmalhsaelwrseeawrte1es1reedntithftfroeeretehdneotEstienmvgeirropouonpimnsteasnnotdavloeLrnatehbgearconouduparsnoeaflcoyofzntehtdreol quantitatively for perfluorooctane sulfonate (PFOS). bam(SHnieneaLrtdlaayPebszCraoemm/ldEitapeuSilssnMeitisnasSwgidnMheeeritdSgee)rbh,emy-axpinFtrnredAaescdesCtvubeTadryel.uuilnaTsiqitshnepudegeidcpvatrcenieohrsisnroeuo.nnsmc-apeanatooierrgxinartabrgapsecehxtnyetc/dreaeclceoutcifrotvkrnoen.spoprwAoracnnyeafdtllauyunotriedrc.oeaTmcl hdhemeemteaaxiislcstsarsaalpcrceetoscnawtvtraoaemmirleaienbqtarluyenatinsntaitthnadetivsetulydy In all dose groups, PFOS levels generally increased through the 26-week time point A relatively dramatic itrnaccrkeeadsefoaicrclyurcrleodsebleytwthereonugthheowutetehke 2stuadnyd.thAelwl meeaktr4ixssapmikpelisnagminptleersvwalerMe waliethainndthfeemQaClegPuFidOelSinleevseplescified by the method RfGcohiolgaloonodwgroeLeu.dasbDiqonaurttaaahtloeiptryrpyercsePoeprnnaattrcreaotditlcihoemensregeaanusisidudrtaeehnlseianahlenyisgsd.ihs3TeoMshfteqsEsauenmarvlepiitrslyouensldt,msaatsecahncaootvaurladlLdiilnaabgbbelotecoroaaanttopstrhpiydilisecSrtaietmabdnleepd.rmaerldeimtOhoipndeasrrayetsiatnangbdPliasrrohecesedudabucjrececostrwdtoienrge to
2 SampleReceipt
rSeeproarst,awmeprleesrewceeriveesdhbipeptwedeteonth10e/E6/n9v8iraonndm3e/2n/t9al9L. aEbnbvyiroCnomvaennctaelLLaabbopraetrosroyn.neSlaimniptilaetseidnaclcuhdaeidn-ionft-hciusstody upon receipt of the samples.
3 Holding Times
There is no holding time criteria associated with these samples for LC/ESMSMS analysis.
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3MENVIRREOPNOMRETNNTOA.LFLAACBTO-TROAXTO-0R3Y0
4 Methods - Analytical and Preparatory
AnFFFFfSraAAAAuolrymCCCCftaiTTTTcSc--t-a-eaMMMMlrnum--t--ms1243e..f..00t1o1rho,,,,rEEomAAOdxxnnltstthaairrvallaeyyccressttFriiiissoolfunnoiofirfdooPFAfffolPPountarooaosttAlrsaayoissnsucssiamhsiiluueyUmmmPssiesiiPPncrUfeeaglirlusfsHfiollnuiuPrngoooLrLooHoCccioPvtt/aaEceLnntrSaCeeEMnss-uexuESsltllffrueoaolccnfntotaranoUtleesasptooiernrraogOOyr/HttMOhhPeetahLrrseFACsrlS-unFEpioloulerenooccictrctrorhooFcemshlmpueeroimtacrryyaoicl/cMaohlneaCmsSsoeimcSraupplmeocuotrnrodOms tehteryr Fluid Using HPLC-Electrospray/Mass Spectrometry
SaAmnpalleytperiespeaxrtaraticotend-fraoqmueaosuasmsapmle pmleastr,iHx wPLithCi/oEnSpMaiSriMngSr:eiaogne-npta[itreitnragbeuxtytrlaacmtimononium hydrogen sulfate
O(TnBcAe t)h] einanaipoHn--TcBonAtroplaleirdisenfovrimroendm, tehnetaTnahleytceaitsiotnraicnsrefeargreendtinsetoleactnivoenly-ptoalragreotsrgaannioicnsicolfvlueonrto(cmhedmhyicl-atlesr.t-
butyl ether), dried, and reconstituted in methanol for MS analysis. HPaIcmsnoonLollaHCuublymtPi/ilEtoeLennS.CpeMPhx,BFatarSasOnaeMsceS,atdtleShimdq:oeuanffarooyontrthemaoedlluyfeagtettfeerxafoiatiinurslteainr8tdcdye.t0twqoaismiuafnitatneeihnlrdjieeutiafcnatoettnestirhav.daleiysaRcwtnaheednoatfearropnalkraytciststohseisneeridwtssitttmeiahcrtreeiaoosmmunbgaoeahrtutywcanhpetreheeodanvfsoetaeinrmssietntehap.etnhhdFHeaaosPcrredoLellPCuixqFmausmOyindSsprtcleesehmlo,arlitounitvmotaieowastntotoiataghtnnhridadneaptlr1hhid%qiecu.id
ForoglalonwicincgomHpPoLuCndsse,pianrcaltuiodnin,gESflMuoSroMchSepmroicvaildse. sEalercatpriodspanradya,cacnuiroanteizmateioannstefcohrnainqauleyzuisnegdapwrimidaerrialyngfoerof dasunebtdescaetqipourniemnotafcrmyolioloilsneic,oucnlhsaarcrriaoecanttese,riisssmtigcaelonlefertrhasleelcyaononapdleyartraeyt,eiiodsnasietclreferclataegtdimv. eeTlnyhtsmisuinilodiqntueisme btpooemtrhabetuaprrerdisme.daMwryoitilhoecnhu,iglwehsh-eaicnrheeraigoryenigzaesd;, detected. Ftmihsoeifrgsraehegxtsmhaemacevonpentledethd,aefrioynsrtaforPmaFogetOmhcSeheran(irQtoasncFitssensdrSuiescQttehiccOat4es9ad8n9a0aanlamydmscuisua,pn(ircoibmonerra4uer9ssye9pdiooisntnods,edibnliuegfcftettdoeriedfSnfaeQtsiraeOttnhe,tePaccnFhhdeOam2rSa3iccf0rateoalrmmcisoutomict(hppCeorris^mcitSoiaomOrnyps^ioao.unnndE. daTschthhisoatifon secondary ion fragmentation patterns.
S Analysis 5.1 Calibration
iAnsmtruidm-leenvteall, dexritfrat cCteadlimbraattriioxnccahliebcrkatsiotanncdhaerdcskasrteancdoamrdpliisaanntaiflyinzestdruemveernyta5l-r1e0spsaomnspeleisswtoitmhionn+it/o-r30% of the expected value. QtrweusopaoenxntitstraeatciootfenodonmfetaohtrerimtxaorcgrueervtseapsneacbliryfaitcceksdeaistuinbggahsteeeadrcihoonngsrLouinusepinarogrfetshgaermemspsulieolstni.palQenaurleaysnsptiiostan(twsieoe-nmigohoftneeiadtocr1hi/nxag,niamflyaoptdepeirsoopbf rtahisaeeted)ionfthe instrum ent
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3MENVIRREOPNOMRETNNTOA.LFLAACBTO-TROAXT-O0R30Y
5.2 Blanks
TAwddoiteixotnraalclyti,otnwbolasnakms,puletsiliozfinbglawnkatmeraatrsixsu, rursoegdafteormthaetriexx,tararecteexdtrcaaclitbedrawtioitnhceuarcvhesb,aatcreheoxftsraamctepdleasl.ong with each batch of samples and curves. Blanks are compliant if no targetanalyte is detected above the limit of detection for a specific analyte. In this study, all blanks were compliant.
5.3 Surrogates
Tetra-hydro perfluorooctane sulfonate is used as a surrogate in this analysis. Surrogate response is monitored to confirm gross instrumental failure, if necessary.
5.4 Matrix Spikes
Duplicate matrix spike analyses utilizing all target analytes were prepared and analyzed for one control tahniismraaLngFe omrasyerbaearnea-leyvsaislu, aretecdo.veries were within the acceptable range o f70-130%. Recoveries outside
5.5 Laboratory Control Samples
Laboratory Control Samples are not a componentofthis study.
5.6 Sample Related Comments
oEtxhterarcmteedtatbisosluiteessawmepreledsewteecrteeds.crIefenneecdefsosarroyt,heexrtkrnacotws mn mayebtaebsocliatnesneodfEfot-rFcOurSrEen-OtlyHuannchdafroarcPteOriAzeAd. No metabolites using a time-of-flight tandem mass spectrometer.
6 Bata Summary
In all dose groups, PFOS levels generally increased through the 26-week time point A relatively dramatic btirnyacctrhkeaeesdmefoaeictrhclyoudrcrleoAdsebfleuytlwlthtearoebnulegthoheof ruwetestuehklets2stiusadnaydtt.athcAheelwldm.eeaktr4ixssapmikpelisnagminptleersvwael reMwaliethainndthfeemQaClegPuFidOelSinleevseplescified This report reflects the most accurate data available at this time. However, all numbers should be considered to be preliminary and are subject to change.
7 Data/Sam ple Retention
Samples and extracts will be retained for future evaluation, if necessary.
8 Attachments
8.1 A ttachm ent A: Graphical and numeric summary of average PFOS levels in sera 8.2 A ttachm ent B: Full table of results for PFOS levels in sera
0036S0
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9 Signatures
Lisa Cdemeyn, AnAalytical Chemist Kris Hansen, Ph.D., Study Director
3MENVIRREOPNOMRETNNTOA.LFLAACBTO-TROAXTO-0R3Y0
l l r t H 1)
Date Date
0036S1
PAGES OF S
300 00 r -- - -................
Covane 29-223
Monkey Serum 6329-223
250 00
200 00
PFOS ug/mL(ppm)
150 00 ----------------------------------------------
100 00
M 0 0 ---------
000 Group 1M, 0.0mg/kg/day Group 1F, O.Omg/kg/day
0.0G2rmougp/k2gMld,ay
Group 2F, 0.02m#1cg/d*y Group 3M, 0.5mg/kg/day Groiqj 3Ft 0.5mg/kg/dy Group 4M, 2mg/kg/day Group 4F, 2mg/k^day
Dose Level
t
Series 1 = Baseline
aSeries 2 =Week 1 Seres 3 = Week 2 Seres 4 = Week 4 Seres 5 = Week 6 Seres 6 = Week 8
EExTcSe-l8V-5o0sion 7 0
Seres 7 = Week 12
HSeres 8 =Week 16 Seres 9 = Week 20 Seres 10 = Week 24 Seres 11 = Week 26
ser223xJs
SSSSeeeernnriieeee34!2 Serie5 S SSSeeerrinieeesss6S? SS3eeenneeessi9i10I
3/29/99
ZS3C00
Srudy Hi.dud Nutnber(Test Substance) Matrix
C 'o v an cr 26 Week Capeuk Toxicity Study with PFUS in Cynomolgus Monkeys T-6295 (PFUS) Monkey Sen
IW U
Sample DaU Monkey Serum
Croup Dose Method Blk Method Blk Matrix Blk Matrix Blk QT-250 ppb (lump 1M, 0 Omy/Vg/dey Group 1F, 0 Omg/kg>day Group 2M, 0 02mg/kf/day Group 2F, 0 02mg/k|/day Group 3M, 0 5m#if/day Group 3F, 0 5mg'kg/day GGrroouupp 44MF,, 22mmgg//kkgf//ddaayy
02/09/99 RWW
02/05/99 SAH
02/09/99 JCP
03/02/99 3AH/RWW 03/10/99 SAH
03/03/99 RWW/JCP 01/03/99 RWW/JCP
________ Baseline_________________________Week! ________________ Week2_________________ W eek4____________________ W eek6_______________ Week ________________Week 12__________
Sample*
Average pros ug/mL
S35 Std. Dev.
Average pros ug/mL
RSD Std. Dev.
Average upgr/mo sL
JtSD Average Std. Dev. p r o s
mg/lmL
ta b Std. Dev.
Average n os WmL
J a b Average Std. Dev. p ro s
ug/mL
rsd
Std. Dev.
Average ------W D p r o s Std. Dev. ug/mL
1120 b K-1 RabHb2itUSBenBcB-2lk-1
vMOL
MDL <MDL MDL <MDL <MDL MDL <MDL <MDL <MDL MDL MOL MOL *MOL
Rabbi) Sen Blk-2
1MDL
<MDL
<MDL <MDL <MDL
<MDL <MOL 101% %
<UDL 103%
MDL 4%
MDL 79%
-MDL 10%
-MW. 79%
-M10%W
117% 5% 123% 0% 120% 2% 96% 3% 98% 2% 77% 11% 77% 11%
MDI. MDL
-MDL <MDL
ckmL <MOt
<MDL <MDL <MDL <MDL MDL
-LOQ LOQ
<L6q <UJQ
<MDL <MDL
<m d L <MDL
" <<ULUGQL'"
MDL LOQ
003)3 0 00409 LOQ LOQ
<MDL <MDL
<MDL 108 <MDL U S
O il) 0137
l1.i3i7
0.104 0.120
399 425
00.)32603
d.io 4.63
o W 3 0.520 638
0 56 892 0 766 0 75 842 0945
H3I5I! <MDL <MDL <MDL
<kibL i u T 5 7 3 25
MDL 4 63
0.568 6.73
<MbL i d i
IW 33.6
<MDL 255
3.38 275
l Id 2 2 i 1.16 20.6 4.41 119 4.05 116
22.3104 tfi 49.4
U .i
23.5
lit
112
i.od 268 io i 888
iid 30.0 lii 133
iii 382 hi 14.8
44 0 34 7
4W97
lii 14)
!?? 146
Sample DaU
3/12/99 SAH/RWW
3/15/99 JCP/SAH
3/16/99 RWW/SAH 3/16/99 RWW/SAH
Monkey Serum Group Dot*
____________________________ Week 16_____________________ Week 20___________________ Week 24________________ Week 26__________
Sample N
Average
R sb Average b s b A n n g t --
Average ------RSD
pros
Std. Dev. p ro s
Std. Dev. n o s Sid. Dot. p r o s Std. Dot.
ug/mL ug/mL ug/mL ug/mL
MMeetthhoodd BBllkk
IRo b H 1120 Blk-2
MDL <MDL MDL <MDL <MDL <MDL MDL <MDL
Matrix Blk Matrix Blk QC *250 ppb
Rabbit Sen Blk-1 Rabbit Sen Blk-2
MDL 99% 106%
<MDL MDL MDL <MDL <MDL MDL <MDL
4% 89% 16% 78%
121%%
89% 90%
8% 2%
85% 86%
17% 1%
Group 1M, 0 Onif/kg/day Group 1F, 0 Ontf/kg'day
LOUKQ)
<Lo q LOQ
0 0551 00690
0000106625
0000651424
o00o0i8o4i
0000672239
0.0143 0.0158
Group 2M, 0 02mg/kg/day Group 2F. 0 02mg/kg'day Group 3M, 0$mg/kg/day Group 3F, 0 5mg/kg/day Group 4M. 2mg/kg/day Group 4F, 2mg/kg/day
140 13 1 701 52 6
30i 2 37 7 29 5 04
1)3 1)3 Hi 72 5
2I 2734 JJf 184
181 l3
0i 8i 4i 2
h i did
73 4 9.04
lii 16.4 idi 833
11..7776 ili 133
235 202
214981
179 194
13 7 27.2
221678
ill" 26.0
Id 214
4 ii 17.7
eot&0Co84
EETxcSe-l8V-5e0rsion 7 ()
Mfi223.xls
3/26/99
CFovAaCncTeT#O63X2-90-32023
Snidy: Product NumbcrCTeat Substance): Matrix: Method/Revision: Analytical Equipment System Number: Instrument Sofiware/Version: Filename: R-Squared Value: Slope: Y-Intercept: Date of Extraction/Analyst: Date of Analysis/Analyst: Date of Data Reduction/Analyst:
BASELINE MONKEY SERA
GDroosuep Sample #
Method Blk
H20 Blk-1
Method Blk
H 20 Blk-2
Matrix Blk
Rabbit Sera Blk-1
Matrix Blk
Rabbit Sera BIk-2
QC - 250 ppb
MKS02059-MS
MKS02059-MSD
Croup 1
I05508M
Control 0.0 mg/kg/day
105S17M I05519M
I05520M
I05526M
I05J27M
105529F
I05S30F
I05531F
I05535F
I05544F
105549F
Group 2
105513M
Low-Dose
105514M
0.02 mg/kg/day
I05515M
I055I6M
I05521M
105525M
I05537F
105541F
I05S43F
I05546F
I05547F
I05550F
Group 3
105S05M
Mid-Dose
I05510M
0.5 mg/kg/day
I05518M
I05523M
I05524M
105528M
I05532F
I05538F
105539F
105545F
I05548F
I05552F
Group 4
105506M
High-Dose
I05507M
2.0 mg/kg/day
105509M
105511M
105512M
I05522M
I05533F
105534F
I05536F
105540F
I05542F
10555 IF
Limit of Quantitation (LOQ): 25 ng/mL
Method Detection Limit (MDL): 12 ng/mL
26 Week Capsule Toxicity Study with PFOS in Cynomolgus Monkeys TM-o6n2kUey(PSPerQaST ------- T ' t * r c lS . ' ) / { , - . ; FACT-M-3.J & FACT-M-4.1 Soup 020199 MassLynx 3.1 See Attachments See Attachments See Attachments See Attachments 02/09/99 RWW 02/13/99 MEE 02/15/99 KJH
Sample Data
PFOS PFOS
Cone. Reported
na/mL ui/mL
<MDL <MDL
<MDL <MDL
<MDL <MDL
<MDL <MDL
298 120%
283 114%
1.64 <MDL
1.68 <MDL
3.42 <MDL
1.81 <MDL
1.97 <MDL
1.83 <MDL
2.59 1.50
<<MMDDLL
2.07 <MDL
1.82 <MDL
1.95 <MDL
5.57 <MDL
Z93 <MDL
1.94 <MDL
0.94 <MDL
2.94 <MDL
Z06 <MDL
2.23 <MDL
1.68 <MDL
2.54 <MDL
2.83 <MDL
2.80 <MDL
21..0835
<MDL <MDL
31..4410
<MDL <MDL
1.86 <MDL
1.31 <MDL
2.15 <MDL
2.98 <MDL
3.40 <MDL
2.57 <MDL
2.47 <MDL
3.53 <MDL
3.85 <MDL
2.35 <MDL
2.50 3.07
<MDL <MDL
2.38 <MDL
2.98 <MDL
2.93 <MDL
3.02 <MDL
2.35 <MDL
2.83 <MDL
3.13 <MDL
3.70 <MDL
2.27 <MDL
3 77 <MDL
Dale Entered/By: 02/17/99 LAC
Date Verified/By: 03/23/99 GML
Average PFOS iig/mL <MDL <MDL 117%
<MDL
<MDL
<MDL
<MDL
<MDL
<MDL
<MDL
<MDL
RSD Std. Dev. <MDL <MDL
5%
<MDL
<MDL
<MDL
<MDL
<MDL
<MDL
<MDL
<MDL
PFOS * Perfluorooclanesulfonate
FACT-M-4.1 Excel Version 7.0
seru223 xls
i/
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Study: Product NumbertTest Substance): MMaettrhioxd: /Revision: Analytical Equipment System Number: Instrument Software/Version: Filename: R-Squared Value: Slope: Y-Intercept: Dale of Extraction/Analyst: Date of Analysis/Analyst: Date of Data Reduction/Analyst:
WEEK 1 MONKEY SERA
Group Sample # Dose
Method Blk Method Blk
H20 Bile-1 H20 Blk-2
Matrix Blk
Rabbit Sera Blk-1
Matrix Blk QC - 250 ppb
Rabbit Sera B)k-2 MKS02059-MS MKS02059-MSD
Group 1 Control
I05508M 105517M
0.0 mg/kg/day
I05519M I05520M
I05526M
I05527M
I05529F
I05530F
10553 IF
I05535F
I05544F
I05549F
Group 2 Low-Dose
105514M 105515M
-o<.hcOlZmg/kg/day
IOSS16M 105521M 105537F
I05541F
I05547F
I05550F
Group 3
I05505M
Mid-Dose
I05510M
-O ri mg/kg/day
105518M I05523M
105524M
I05528M
105532F
I05538F
I05539F
105545F
I05548F
I05552F
Group 4
I05506M
High-Dose
I05507M
-*0 mg/kg/day
Ito05s5s0i9IMM
105512M
I05522M
I05533F
I05534F
105536F
I0554OF
I05542F
10555 IF
Limit of Quanutauon (LOQ): 25 ng/mL
Method Detection Limit (MDL): !2ng/mL
26 Week Capsule Toxicity Study with PFOS in Cynomolgus Monkeys T-6295 (PFOS) Monkey Sera FACT-M-3.1 A FACT-M-4.1 Madeline 041098 4 Amelia 062498 MassLynx 3.1 See Attachments See Attachments See Attachments See Attachments 02/05/99 SAH 02/08/9,02/10/99.02/12/99,02/17/99 HOJ/DRB 02/10/99,02/16/99,02/26/99 HOJ/DRB
Sample Data
PFOS PFOS Average
Cone. nt/mL
Ruexp/omrtLed
uPgF/OmSL
<MDL <MDL
<MDL <MDL <MDL
<MDL <MDL
<MDL <MDL <MDL
305 123
304 123% 123%
0.00 <MDL
0.00 <MDL
0.00 <MDL
0.00 <MDL
0.00 <MDL
0.00 <MDL <MDL
0.00 <MDL
0.00 <MDL
0.00 0.00
<<MMDDLL
0.00 <MDL
0.00 <MDL <MDL
495 0.990
383 0.957
519 1.04
677 1.35 1.08
684 1.37
464 1.16
581 519
1.16 1.04 1.18
287 5.74
209 5.23
342 221
6.84 4.41
318 413
5.30 689
5.74
161 5.38
257 5.15
248 4.13
184 4.61
232 465
195 3.90 4.63
665 411
26.6 27.4
351 482
23.4 24.1
711 28.5
539 26.9 26.2
564 28.2
451 22.6
393 26.2
419 209
749 29.9
377 25.1 255
Date Entered/By: 02/10/99.03/02/99 LAC
Date Verified/By: 03/23/99 GML
RSD Std. Dev. <MDL <MDL
0
<MDL
<MDL 16.9 0.183 11.6 0.137
17.0 0.976
12.3 0.57
7.49 1.96
13.3 3 38
PFOS * Perfluorooctanesulfonate
FACT-M-4 1 Excel Version 7 0
sera22.1xls
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Study: Product NumberfTest Substance): Matrix: Method/Revision: Analytical Equipment System Number: Instrument Software/Version: Filename: R-Squared Value: Slope: Y-Intercept: Date of Extnction/Analyst: Date of Analysis/Analyst: Date of Data Reduction/Analyst:
WEEK 2 MONKEY SERA
Group Sample # Dose
Method Blk Method Blk
H 20 BUc-1 H20 Blk-2
Matrix Blk
Rabbit Sera Blk-1
Matrix Blk
Rabbit Sera BUt-2
QC - 250 ppb
MMKKSS0022005599--MMSSD
Group 1
I05508M
Control
I05517M
0.0 mg/kg/day
I05519M
I05520M
I05526M
I05527M
I05529F
I05530F
10553 IF
I05535F
I05544F
I05549F
Group 2
105514M
Low-Dose
105515M
0.02 mg/kg/day
105516M
105521M
I05537F
105541F
I05547F
I05550F
MGirdo-uDpos3e
I05505M I05510M
0.5 mg/kg/day
105518M
I05523M
105524M
I05528M
I05532F
105538F
I05539F
I05545F
I05548F
I05552F
Group 4
I05506M
High-Dose
I05507M
2.0 mg/kg/day
I05509M
105511M
105512M
I05522M
I05533F
I05534F
I05536F
I05540F
105542F
10555 IF
Limit of Quantitation (LOQ): 25 ng/mL
Method Detection Limit (MDL): !2ng/mL
26 Week Capsule Toxicity Study with PFOS in Cynomolgus Monkeys T-6295 (PFOS) Monkey Sera FACT-M-3.1 4FACT-M-4.I Madeline 041098 li Amelia 062498 MassLynx 3.1 See Attachments See Attachments See Attachments See Attachments 02/09/99 JCP 02/15/99,02/22/99 HOJ 02/19/99,02/25/99 HOJ
Sample Data
PFOS PFOS Average
nCgo/mneL.
Reported ug/mL
PFOS ug/mL
cMDL <MDL
<MDL <MDL <MDL
<MDL <MDL
<MDL <MDL
<MDL
293 300
118 121% 120%
4.09 <MDL
3.07 <MDL
4.53 <MDL
2.08 <MDL
2.02 <MDL
1.89 <MDL <MDL
0.520 <MDL
1.02 <MDL
1.90 <MDL
3.12 <MDL
0.380 <MDL
0.810 <MDL <MDL
575 1.28
513 1.28
492 1.49
425 1.42 1.37
446 1.49
722 1.44
527 550
1.32 1.22
1.37
227 7.58
301 6.01
350 8.75
285 5.69
195 7.78
384 7.68 7.25
173 5.75
416 8.33
232 5.80
329 6.59
320 8.01
295 5.90 673
747 37.3
626 31.3
746 299
706 28.2
976 39.1
899 35.9 33.6
778 31.1
650 588
3229..54
546 24.3
372 24.8
568 22.7 27.5
Date Entered/By: 02/22/99.03/02/99 LAC
Date Verified/ By: 03/23/99 GML
RSD Std. Dev. <MDL <MDL
2%
<MDL
<MDL 7.63 0.104 8.79 0.120
16.1 1.16
17.2 1.16
13.1 4.41
14.8 4 05
PFOS * Perfluorooctanesulfonate
FACT-M-4.1 Excel Version 7 0
sera223.xls
003686
3/26/99
CFovAaCnTceT# O63X2-90-32023
Study: Product NumberfTesl Substance): Matrix: Melhod/Revision: Analytical Equipment System Number:
26 Week Capsule Toxicity Study with PFOS in Cynomolgus Monkeys T-6295 (PFOS) Monkey Sera ETS-8-4.0 and ETS-8-5.0 Madeline 041098. Amelia 062498, & Soup 020199
Instrument Softwate/Version: Filename:
MassLynx 3.1and 3.2 See Attachments
R-Squared Value: Slope: Y-Intercept: Date of Extraction/Analyst: Date of Analysis/Analyst:
See Attachments See Attachments See Attachments 03/02/99 SAH/RWW 03/05/99,03/08/99.03/25/99 HOJ/MEE/DRB
Date of Data Reduction/Analyst:
03/08/99,03/26/99 KJH/DRB
Sample Data
WEEK 4 MONKEY SERA
Group Dose
S am ple#
PFOS Cone.
PFOS Reported
Average PFOS
RSD Std. Dev.
ng/mL ut/mL ug/mL
Method Blk Method Blk
H20 Blk-1 H20 Blk-2
0 0
<MDL <MDL <MDL <MDL
Matrix Blk
Rabbit Sera Blk-I
0
<MDL
Matrix Blk
Rabbit Sera Blk-2
0
<MDL <MDL <MDL
Matrix Blk Matrix Blk Matrix Blk
Monkey Sera Blk-1 Monkey Sera Blk-2 Monkey Sen Blk-3
7.21 7.17 7.26
<LOQ <LOQ <LOQ <LOQ <LOQ
Matrix Blk
Monkey Sera Blk-4
6.32
<LOQ <LOQ <LOQ
QC - 250 ppb
MKS03029-MS-1
253
102
MKS03029-MSD-1
250
101 101 1%
QC - 250 ppb
MKS03029-MS-2
242
98%
MKS03029-MSD-2
235
95* 96 3*
Group 1
I05508M
5.43 <LOQ
Control
I05517M
6.76 <LOQ
0.0 mg/kg/day
105519M
7.91 <LOQ
I05520M
6.11 <LOQ
I05526M
6.73 <LOQ
I05527M I05529F
1.98 6.63
<<LLOOQO <LOO <LOQ
I05530F
6.11 <LOQ
I05531F
9.19 <LOQ
I05535F
8.17 <LOQ
I05544F
9.% <LOQ
I05549F
8.74 <LOQ <LOQ <LOQ
Group 2
105514M
108 3.58
Low-Dose 0.02 mg/kg/day
10S515M 105S16M
172 3.43 196 3.91
18.1
I05S21M
101 5.03 3.99 0.720
I05537F
186 4.65
I05541F
153 3.83
I05547F I05550F
221 163
4.43 4.08
8.53 4.25 0.363
Group 3
I05505M
63.7 21.2
Mid-Dose
105510M 64.6 21.5
0.5 mg/kg/day
105518M
101 25.2
I05523M I05524M I05528M
110 22.0
96.3 95.7
19.3 23.9
9.47 22.2 2.10
I05532F
41.4 20.7
I05538F
117 23.3
I05539F
35.8 17.9
I05545F
46.7 23.4
I05548F I0S552F
78.3 55.9
196 18.6
114 20.6 2.34
Group 4
I05506M
118 295
High-Dose 2.0 mg/kg/day
I05507M I05509M 10551IM 105512M I05522M
27.2 27.3 24.2 29.0 30.8
90.6
68.4
60.5
96.6 103
73.8 119 87 8
I05533F 35.2 176
I05534F 36.3 181
I05536F I05540F I05542F 10555 IF
24.0 80.0
834 83.4
29 4 15.0
97.8 75.2
42.7 116 49 4
Limit of Quantitation (LOQ): PFOS 15.2 ng/mL Method Detection Limit (MDL): PFOS 4.76 ng/mL
Date Entered/By: 03/08/99,03/26/99 LAC Date Verified/ By: 03/23/99 GML
PFOS = Perfluorooctanesulfonate
003637
ETS-8-5.0 Excel Version 7.0
sera223.xls
3/26/09
CFoAvaCnTceT#O63X2-90-32023
Study: 26 Week Capsule Toxicity Study with PFOS in Cynomolgus Monkeys
Product NumberfTest Substance):
T-6295 (PFOS)
Matrix:
Monkey Sera
Method/Revision:
ETS-8-4.0 and ETS-8-5.0
Analytical Equipment System Number:
Madeline 041098. Amelia 062498, & Soup 020199
Instrument Softwtue/Version:
MassLynx 3.1 and 3.2
Filename:
See Attachments
R-Squarcd Value:
See Attachments
Slope: See Attachments
Y-Intercepl: Date of Extraction/Analyst:
See Attachments 03/10(99 SAH
Date of Analysis/Analyst:
03/12/99,03821/99 MEE/DRB
Date of Data Reduction/Analyst:
03//18/99,03/24/99 LAC/DRB
Sample Data
WEEK 6 MONKEY SERA
Group Dote
Semple #
PFOS Cone.
PFOS Reported
Average PFOS
RSD Std. Dev.
ng/mL ug/mL ug/mL
Method Blk
H20Blk-l
0.00 <10 ppb
Method Blk Matrix Blk Matrix Blk
H20 Blk-2 Rabbit Sera BUt-1 Rabbit Sera Blk-2
7.74 0.00 4.19
<10 ppb <10 ppb <10 ppb
<10 ppb <10 ppb
<10 ppb <10 ppb
Matrix Blk
Monkey Sera Blk-1
2.56
<10 ppb
Monkey Sera Blk-2
2.55
<10 ppb
Monkey Sera Blk-3
1.93
<I0ppb
Monkey Sera Blk-4
0.5
<10 ppb
<10 ppb <10 ppb
QC - 250 ppb
MKS03109-MS-1
264
106
MKS03109-MSD-1
253
101* 103* 4%
QC - 250 ppb
MKS03109-MS-2
243
97%
MKS03109-MSD-2
249
100* 98* 2
Group 1
I05S08M
0.00 <MDL
Control
I055I7M
0.00 <MDL
0.0 mg/kg/day
I05519M
0.00 <MDL
I05520M
1.60 <MDL
I05526M
0.61 <MDL
I05527M
9.49 <MDL <MDL <MDL
105529F
1.56 <MDL
I05530F
3.38 <MDL
10553IF
4.24 <MDL
105535F
0.00 <MDL
I05544F I05549F
0.00 <MDL 3.54 <MDL <MDL <MDL
Group 2
105514M
36.6 4.58
Low-Dose
105515M
33.1 4.13
0.02 mg/kg/day
105516M
32.5 4.06
11.9
I0SS21M
41.8 5.23 4.50 0.537
I05537F
42.7 5.34
105541F
45.7 4.57
I05547F I05550F
36.4 4.55
11.2
32.7 4.08 4.63 0.520
Group 3
I05505M
87.4 26.2
Mid-Dose
105510M
56.1 28.1
0.5 mg/kg/day
105518M I05523M 105524M
66.9 25.1 61.9 23.2 72.7 27.2
8.09
I05528M
61.6 23.1 25.5 2.06
105532F
61.2 23.0
I05538F
94.5 23.6
I05539F
61.4 23.0
I05545F I05548F
94.5 28.4 61.3 23.0
11.4
(OJ5J2F
67.0 20.1 23.5 2.68
Group 4
I05506M
182 114
High-Dose 2.0 mg/kg/day
I05507M I05509M 105511M 105512M 105522M
165 230 234 211 203
103 115 117 132 8.54 127 118 10.1
I05533F
232 116
I05534F
166 104
I05536F
179 112
I05540F 105542F 10555 IF
227 203 205
113 127 102
112 78..8980
Limit of Quantitation (LOQ): 25 ng/mL
Date Enlered/By: 03/19/99,03/24/99 LAC
Method Detection Limit (MDL): 12 ng/mL
Date Verified/By: 0
PFOS Perfluoroocianesulfonate
irrs-H-5 o Excel Version 7 0
sera223.xls
0036S8
3/26/99
CFovAaCncTeT#O63X2-90-32023
Study: 26 Week Capsule Toxicity Study with PFOS in Cynomolgus Monkeys
Product NumberfTest Substance): Matrix:
TM-o6n2k9e5y(PSFerOaS)
Method/Revision: Analytical Equipment System Number: Instrument Softwarc/Version: Filename: R-Squared Value: Slope:
ETS-8-4.0 and ETS-8-5.0 Soup 020199 MassLynx 3.1and 3.2 See Attachments See Attachments See Attachments
Y-Intercepl:
See Attachments
Date of Extraction/Analyst:
03/03/99 RWW/JCP
Date of Analysis/Analyst: Date of Data Reduction/Analyst:
03/05/99,030999,03/25/99 HOJ/MEE/DRB 03/08/99,03/15/99,03/26W DRB
Sample Data
WEEK 8 MONKEY SERA
Group Sample # Dace
prosCone.
ng/mL
RPepFoOrtSed ug/mL
Average PFOS ug/mL
RSD Std. Dev.
Method Blk
H20 Blk-I
0.00 <MDL
Method Blk
H20 Blk-2
0.00 <MDL <MDL <MDL
Matrix Blk
Rabbit Sera BIk-1
0.00
<MDL
Matrix Blk
Rabbit Sera Blk-2
0.00
<MDL <MDL <MDL
Matrix Blk
Monkey Sera Blk-1
0.00
<MDL
Matrix Blk
Monkey Sera BIk-2
0.00
<MDL <MDL <MDL
QC - 250 ppb
MKS03039-MS-1
174
70*
QC 250 ppb
MKS03039-MSD-1 MKS03039-MS-2
191 205
77* 73* 9* 83*
Q C -250 ppb
MKS03039-MSD-2 MKS03039-MS-3 MKS03039-MSD-3
185 181 203
75* 79* 10* 7832** 77* 11%
Group 1
I05508M
9.43 <MDL
Control
I05517M
7.68 <MDL
0.0 mg/kg/day
I0S519M
12.0 <MDL
I05520M
9.03 <MDL
I0S526M
11.0 <MDL
I05527M
28.8 0.0480 <MDL <MDL
I05529F
16.0 <LOQ
I05530F
18.3 <LOQ
10553IF
18.0 <LOQ
I05535F
14.5 <LOQ
I05544F
9.46 <MDL
Group 2
I05549F 105514M
15.0 37.2
<6L.2O0Q <LOQ <LOQ
Low-Dose
I055I5M
33.8 5.63
0.02 mg/kg/day
10S516M
47.1 6.73
8.88
105521M I05537F
34.4 49.2
6.88 7.03
6.36 0.565
105541F
39.0 6.51
I05547F
40.1 6.68
11.8
I05550F
37.1 5.30 6.38 0.752
Group 3
I05505M
122 34.8
Mid-Dose 0.5 mg/kg/day
105510M I05518M
9842..19
27.6 31.4
I05S23M
91.6 30.5
I05524M
118 39.4
12.7
I05S28M
107 30.7 32.4 4.12
I05532F
86.1 34.5
I05538F
106 30.3
I05539F
82.6 33.1
105545F
122 30.5
I05548F
694 27.8
12.7
I05552F
59.5 23.8 30.0 3.82
Group 4 High-Dose
I0SS06M I05507M
122 157 83.8 107
2.0 mg/kg/day
I05S09M
117 128
105511M
89.8 115
I055I2M
IIS 147
16.7
I05522M
127 163 136 22.8
I05533F
107 138
I05534F
98.1 151
I05536F
100 128
I05540F
102 131
I05542F 10555 IF
113 99.2
114059
11.1 133 14.8
Limit of Quantitation (LOQ): 25 ng/mL
Date Entered/By: 03/08/99,03/24/99,03/26/99 LAC
Method Detection Limit (MDL): 12 ng/mL
Date Verified/By: 0
PFOS Perfluorooctanesulfonaie
ETS-8-5.0 Excel Version 7.0
sera223 xls
003689
3/26/99
CFovAaCnTceT#O63X2-90-32023
Study: 26 Week Cipiule Toxicity Study with PFOS in Cynomoigui Monkeys
Product Number(Test Substance):
T-629S (PFOS)
Matrix:
Monkey Sera
Method/Revision:
ETS-8-4.0 and ETS-8-5.0
Analytical Equipment System Number
Soup 020199
Instrument Software/Version: Filename:
MassLynx 3.2 See Attachments
R-Squared Value:
See Attachments
Slope: See Attachments
Y-Intercept: Date of Extraction/Analyst:
See Attachments 03/03/99 RWW/JCP
Date of Analysis/Analyst: Date of Data Reduction/Aoalyst:
3/09/99.03/10/99.03/25/99 DRB 03/15/99,03/24/99,03/26/99 DRB
Sample Data
WEEK 12 MONKEY SERA
Group Dose
S am p le#
PFOS Cone. ng/mL
PFOS Reported ug/mL
Average PFOS ug/mL
RSD Std. Dev.
Method Blk Method Blk Matrix Blk
H20 Blk-1 H20 Blk-2 Rabbit Sera Blk-1
0.00 0.00 0.00
<<MMDDLL <MDL <MDL <MDL
Matrix Blk
Rabbit Sen Blk-2
0.00
<MDL <MDL <MDL
Matrix Blk Matrix Blk
Monkey Sen Blk-1 Monkey Sen Blk-2
0.00 0.00
<MDL <MDL
<MDL <MDL
QC - 250 ppb
MKS03039-MS-1
174
70
MKS03039-MSD-I
191
77 73* 9*
QC - 250 ppb
MKS03039-MS-2 MKS03039-MSD-2
205 185
83% 75 79* 10*
Q C -250 ppb
MKS03039-MS-3 MKS03039-MSD-3
181 203
73* 82*
77*
11*
Group 1 Control 0.0 mg/kg/day
I05508M I05517M I05519M I05520M
30.9 0.0476 26.9 0.0537 32.8 0.0547 12.7 <LOQ
I05526M
21.3 <LOQ
7.67
I05527M
32.6 0.0572 0.0533 0.00409
I05529F
13.2 <LOQ
I05530F
18.4 <LOQ
10553 IF
21.1 <LOQ
I05535F
11.2 <MDL
I05544F
20.2 <LOQ
I05549F
25.6 0.0433 <LOQ <LOQ
Group 2
105514M
44.7 8.278
Low-Dose 0.02 mg/kg/day
I0S515M IOS5I6M
47.5 8.636 50.6 8.72
8.59
I05521M
48.1 100 8.92 0.766
I05537F
61.3 9.02
I05541F I05547F 105550F
3379..56 52.0
7.49
9.43 7.76
8.42 01.914.25
Group 3 Mid-Dose 0.5 mg/kg/day
I05505M I05510M 105518M
143 50.0 135 49.0 133 42.1
I05523M I05524M
88.0 44.0 118 47.1
15.3
I05528M
79.2 31.7 44.0 6.73
I05532F
86.9 32.2
I05538F I05539F
94.2 101
41.0 34.7
I05545F II0055554582FF
109 40.2
7779..46
28.9 14.3 30.9 34.7 4.97
Group 4 High-Dose 2.0 mg/kg/day
I05506M I05507M I05509M 105511M
103 144 86.4 133 116 154 83.9 124
105512M I05522M
149 88.0
209 19.6 150 152 299
I05533F I05i34F
109 100
IS8 143
I05536F I05540F I05542F 10555 IF
63.6 80.0
122 140
128 114
164 100 146 145 14.6
Limit of Quantitation (LOQ): 25 ng/mL
Date Entered/By: 03/08/99,03/24/99,03/26/99 LAC
Method Detection Limit (MDL): 12 ng/mL
Date Verified/By: 0
PFOS Perfluorooctanesulfonate
[rrs-8-5.0 Excel Version 7 0
sera223.xls
003690
3/26/99
CFovAaCncTeT#O63X2-90-32023
Study: Product Number(Tesl Substance): Matrix: Method/Revision: Analytical Equipment System Number: Instrument Software/Venion: Filename: R-Squared Value: Slope: Y-Intercept: Date of Extraction/Analyst: Date of Analysis/Analyst: Date of Data Reduction/Analyst:
26 Week Capsule Toxicity Study with PFOS in Cynomolgus Monkeys T-6295 (PFOS) Monkey Sera ETS-8-4.0 and ETS-8-5.0 Soup 020199 MassLynx 3.2 See Attachments See Attachments See Attachments See Attachments 3/12/99 SAH/RWW 03/13/99,03/19/99 DRB 03/16/99.03/24/99 DRB
Sample Data
WEEK 16 MONKEY SERA
CDroosuep
Sample #
PFOS Cone
PFOS Reported
Average PFOS
RSD Std. Dev.
ng/mL ug/mL ug/mL
Method Blk Method Blk Matrix Blk Matrix Blk
H20 Blk-1 H20 Blk-2 Rabbit Sera Blk-1 Rabbit Sera Blk-2
0.00 0.00 0.00 0.00
<MDL <MDL <MDL <MDL <MDL <MDL <MDL <MDL
Matrix Blk Matrix BUc
Monkey S en Blk-1 Monkey Sen Blk-2
36.21 21.43
0.03621 0.02143
0.0288
0
QC - 250 ppb
M K S 0 3 129-M S -1 MKS03129-MSD-1
280 269
101% 97% 99% 4%
QC - 230 ppb
MKS03129-MS-2
269
97%
MKS03129-MSD-2
316
116% 106% 16%
Group 1 Control 0.0 mg/kg/day
I05508M I05517M I035I9M I05J20M
21.5 <LOQ 20.4 <LOQ 21.1 <LOQ 20.7 <LOQ
I03326M I05327M
3189..49
<LOQ 0.0767 <LOO <LOO
I03329F I05330F
35.5 0.0546 25.7 <LOQ
10553 IF I05535F
21.5 <LOQ 9.57 <LOQ
I05544F
11.6 <LOQ
I05549F
28.9 0.0577 <LOQ <LOQ
Group 2 Low-Dose 0.02 mg/kg/day
105514M I055I5M I0S516M I05521M
77.7 13.0
47.3 11.8
81.7 12.6
21.9
83.1 18.5 140 3.05
I05537F 10554 IF I05547F I05550F
76.4 13.9
69.2 15.4
66.8 13.4
18.1
53.9 980 13.1 2.37
Group 3 Mid-Dose 0.3 mg/kg/day
I05505M I055I0M 105518M
222 74.1 330 66.1 379 75.7
I05523M I05524M
326 65.2 475 79.2
10.4
I05528M
362 60.3 70.1 7.29
I05532F
252 50.4
I05538F
279 46.5
I05539F
347 57.8
I05545F I05548F I05552F
323 538
324213
58.7 9.59 48.2 52.6 5.04
Croup 4 High-Dose 2.0 mg/kg/day
I05506M I05507M I05509M
273 228 257 214 296 246
105511M 105512M I05522M I05533F
268 223
296 270
8.42
254 231 235 19.8
245 204
I05534F I05536F
196 196 184 229
I05540F I05542F 105551F
258 231 191
215 210 159
11.9 202 24.1
Limit of Quantitation (LOQ): 25 ng/mL
Dale Entered/By: 03/08/99,03/17/99,03/24/99 LAC
Method Detection Limit (MDL1: )2ng/mL
Date Verified/By: 0
PFOS = Perfluorooctanesulfonale
ETS-8-5 0 Excel Version 7 0
sera22.Vx)s
003691
3/26/99
CFovAaCnTceT#O63X2-90-32023
Study: 26 Week Capsule Toxicily Study with PFOS in Cynomolgus Monkeys
Product NumberCTest Substance):
T-6295 (PFOS)
Matrix:
Monkey Sera
Method/Revision:
ETS-8-4.0 and ETS-8-5.0
Analytical Equipment System Number:
Soup 020199
Instrument Soflware/Venion:
MassLynx 3.1
Filename:
See Attachments
R-Squared Value:
See Attachments
Slope: Y-Intercept: Date of Extraction/Analyst: Date of Atialysis/Analyst: Date of Data Reducdon/Analyst:
See Attachments See Attachments 3/15/99 JCP/SAH 03/16/99 DRB 03/17/99 DRB
Sample Data
WEEK 20 MONKEY SERA
Croup Dose
Sample #
PFOS
PFOS
Average
RSD
Cone. ng/mL
Ruegp/omrtLed
PFOS Std. Dev. ug/mL
Method Blk Method Blk Matrix Blk Matrix Blk Matrix Blk Matrix Blk QC - 250 ppb
H20 Blk-I H20 Blk-2 Rabbit Sen Blk-1 Rabbit Sen Blk-2 Monkey Sen Blk-I Monkev Sen Blk-2 RBS03159-MS-1 RBS03159-MSD-1
0.00 0.00 0.00 0.00 0.00 0.00 232 208
<<MMDDLL <MDL <MDL <MDL <MDL <MDL <MDL NA NA NA NA 94% 84% 89% 11%
QC - 250 ppb
RBS03159-MS-2 RBS03159-MSD-2
191 195
77% 79% 78% 2%
Group 1 Control
I05508M I05517M
30.4 0.0434 31.4 0.0523
0.0 mg/kg/day
I0S519M I05520M
19.3 <LOQ 23.2 <LOQ
I05526M I05527M
30.0 31.5
0.0461 0.0788
0.0551
29.4 0.0162
I05529F
51.6 0.0770
I05530F
38.3 0.0722
10553 I F 105535F I05544F I05549F
28.3 0.061J
19.4 <LOQ
29.6 39.1
0.0630 0.0711
9.5 0.0690 0.0065
Group 2 Low-Dose 0.02 mg/kg/day
I05514M I05515M I05516M 10552IM I05537F I05541F 105547F I05550F
88.6 15.5
86.7 13.3
101 98.3
14.9 17.6
11.4 15.3 1.74
70.2 73.2 96.6 359
13.8 14.4 17.9 51.3
14.6
15.3
2.23 74.4
24.3 IS.I
Group 3 Mid-Dose
I05505M 105510M
237 77.8 253 79.0
0.5 mg/kg/day
1055 IBM I05523M I05524M I05528M I05532F
248 78.8
319 220 223
93.8 79.9 67.6
10.5 79.5 8.37
255 86.4
I05538F
201 59.1
I05539F 105545F I05548F I05552F
210 97.6
171 204 154
57.0 81.5 53.3
25.4 72.5 184
Group 4
I05506M
381 197
High-Dose 2.0 mg/kg/day
I05507M 105509M 105511M 105512M I05522M I05533F
282 173
315 189
352 309 302
158 178 ISI
7.62 179 13.7
393 210
I05534F I05536F
303 178 274 182
I05540F I05542F 10555 IF
441 302 330
241 189
140
165 194 27.2
Limit of Quantitation (LOQ): 25 ng/mL
Date Entered/By: 03/08/99,03/17/99 LAC
Method Detection Limit (MDL): !2ng/mL
Dale Verified/By: 0
PFOS = Perfluorooctanesulfonate
* Calculated without sample I05J50F.
ETS-8-5 0 Excel Version 7 0
sera223 xls
003692
3/26/99
CFovAaCncTeT#O63X2-90-32023
Study: Product NumbcrCTesl Substance): Matrix: Method/Revision: Analytical Equipment System Number: Instrument Software/Version: Filename: R-Squared Value: Slope: Y-Intercept: Date of Extraction/Analyst: Date of Analysis/Analyst: Date of Data Reduction/Analyst:
26 Week Capsule Toxicity Study with PFOS in Cynomolgus Monkeys T-6295 (PFOS) Monkey Sera ETS-8-4.0 and ETS-8-5.0 Amelia 062498 & Soup 020199 MassLynx 3.1 See Attachments See Attachments See Attachments See Attachments 3/16/99 RWW/SAH 03/17/99,03/23/99 DRB 03/23/99,03/24/99 DRB
S am p le Data
WEEK 24 MONKEY SERA
Group Dose
S am ple#
PFOS PFOS Avenge RSD
nCgo/mneL
Reported ug/mL
PFOS Std. Dev. ug/mL
Method Blk Method Blk Matrix Blk Matrix Blk Matrix Blk Matrix Blk QC - 250 ppb
H20 Blk-1 H20 Blk-2 Rabbit Sera Blk-1 Rabbit Sera Blk-2 Monkey Sera Blk-1 Monkey Sera Blk-2 RBS03169-MS-1 RBS03169-MSD-1
0.00 0.00 0.00 0.00 0.00 0.00 218 236
<MDL <MDL
<MDL <MDL
<MDL <MNADL
<MDL <MDL
NA NA NA
88%
95% 92% 8%
QC - 250 ppb
RBS03169-MS-2 RBS03169-MSD-2
231 213
93% 86% 89% 8%
Q C -250 ppb
RBS03169-MS-3 RBS03169-MSD-3
224 220
90% 89% 90% 2%
Group 1 Control 0.0 mg/kg/day
I05508M I05517M I055I9M I05520M I05526M I05527M I05529F
36.4 0.0560
30.3 0.0606
25.8 0.0517
19.4 <LOQ 24.8 <LOQ
17.7
36.7 0.0765 0.0612 0.0109
40.4 0.06
I05530F 10553IF I0553SF I05544F I05549F
24.2 <LOQ
25.9 0.05
8.36 16.2 33.4
<LOQ <LOQ 15.4 0.06 00544 0.0084
Group 2 Low-Dose 0.02 mg/kg/day
105514M I05515M I055I6M 105521M 105537F
115 18.3
85 13.6 132 17.6
21
141 22.9 18.12 3.815
134 16.7
I05541F I05547F I05550F
133 85 108
17.1
15.9 15.2
16.25 0.8542
Group 3 Mid-Dose 0.5 mg/kg/day
105505M I05510M I0S518M I05523M I05524M I05528M 105532F I05538F
251 96.6
186 81.4
191 73.4
164 74.4
201 155
86.8 10 80.9 82.26 8.58
145 78.7
153 60.6
I05539F 105545F I05548F I05552F
142 86.8
168 79.3
196 139
7707.01 7541 91.024
Group 4 High-Dose 2.0 mg/kg/day
I0S506M I055O7M I05509M 110055551121MM 105522M
287 247.1
234 234.4
MM
258 257.9
309 233
329018..46
11.61 267.86 31.1
I05533F I05534F I05536F I05540F I05542F 10555 IF
280 225
225307..16
207 210.8
218 187.8
240 226.5
12.0
131 187.1 216.64 26.0
Limit of Quantitation (LOQ): 25 ng/mL
Date Entered/By: 03/24/99 LAC
Method Detection Limit (MDL): 12 ng/mL
Date Verified/By: 0
PFOS Perfluorooctanesulfonate
CTS-K-5.0 Excel Version 7.0
sera223.xls
003693
3/26/99
CFoAvaCnTceT#O63X2-90-32023
Study: Product NumberfTest Substance): Matrix: Method/Revision: Analytical Equipment System Number:
26 Week Capsule Toxicity Study with PFOS in Cynomolgus Monkeys T-6295 (PFOS) Monkey Sera ETS-8-4.0 and ETS-8-5.0 Amelia 062498. Soup 020199
Instrument Software/Version: Filename: R-Squared Value: Slope: Y-Intercept: Date of Extraction/Analyst:
MassLynx 3.1 See Attachments See Attachments See Attachments See Attachments 3/16/99 RWW/SAH
Date of Analysis/Analyst: Date of Data Reduction/Analyst:
03/17/99,03/21/99 DRB/MEE 03/23/99.03/22/99 DRB/MEE
Sample Data
WEEK 26 MONKEY SERA
Group
S am ple#
PFOS PFOS Average RSD
Dose
nCeo/mneL.
Reported ut/m L
PFOS Std. Dev. ug/rnL
Method Blk Method Blk
H20 Blk-1 H20 Blk-2
0.00 <MDL 0.00 <MDL <MDL <MDL
Matrix Blk Matrix Blk
Rabbit Sera Blk-1 Rabbit Sera Blk-2
0.00 0.00
<MDL <MDL <MDL <MDL
Matrix Blk
Monkey Sera Blk-1
0.00
<MDL
M anx Blk
Monkey Sera Blk-2
0.00
<MDL <MDL <MDL
QC - 250 ppb
RBS03169-MS-I
210
85
RBS03169-MSD-l
232
94 89* 10
QC - 250 ppb
RBS03169-MS-2 RBS03169-MSD-2
229 193
7982** 85* 17*
QC - 250 ppb
RBS03169-MS-3 RBS03I69-MSD-3
211 213
85* 86* 86* 1*
Group 1
105508M
30.9 0.0619
Control
I05517M
31.0 0.0673
0.0 mg/kg/day
105519M I05520M I05526M
27.1 0.0521 16.8 <LOQ 26.7 0.0469
22.9
I05527M
41.7 00835 0.0623 0.0143
I05529F
48.22 0.0765
I05530F
59.68 0.0918
10553IF
30.12 0.0538
I05535F
16.61 <LOQ
I05544F 105549F
21.61 <LOQ
21.7
34.69 0.0694 0.0729 0.0158
Group 2 Low-Dose 0.02 mg/kg/day
I0S514M 105515M 105516M
151 20.2 143 20.6 131 17.2
8.91
105521M 105537F
112 21.1 19.8 1.76 101 16.8
I0554IF 105547F I05550F
113 18.5
140 85
16.2 14.2
10.8 16.4 1.77
Group 3
105505M
255 116
Mid-Dose 0.5 mg/kg/day
105510M I0S518M I05523M 105524M I05S28M
149 162
142 86.7
176 89.9 160 86.7
30.4
156 77.8 103 31.4
I05532F
209 79.2
105538F
150 73.6
I05539F
216 90.1
I05545F I05548F 105552F
269 107
145 80.6
16.3
142 69.4 83.3 13.5
Group 4
I05506M M M
High-Dose
I05507M
213 227
2.0 mg/kg/day
105509M 105511M
MM 248 177
105512M I05522M
285 298
18S 276
216 2451..50
I05533F
340 253
105534F I05536F
308 233 155 193
105540F I05542F 10555 IF
278 221
206 163
210767
13.0 214 27.7
Limit of Quantitation (LOQ): 25 ng/mL
Date Entered/By: 03/23/99 LAC
M Moribund
Method Detection Limit (MDL): 12 ng/mL
Date Verified/By: 0
PFOS Perfluorooctanesulfonate
ETS-8-5 0 Excel Version 7.0
sera223.xls
003S94
3/26/99