Document p2M8g4Knpk47ny9M4NpN5338a
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3M
SKaatlheVriineePEr. eRseeendt. PhD.
ISaftEynvOipreornamteionntsal Heath and
R226- 3SHT
S9u000PBBoluxsMh33NA3v3e1n1u3e,33B3u3i1n 423.25 he
co . Bests Centted aan
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LS .
August 26, 2005
TEHQ-5039
RDoocoumme6n4t28Processing Center (Mail Code 7407M)
NO TSCA CBI
UOAtfStf.einctEeinoovfnoi:rlolTnaSmeiCnoAtnaFl(uPv)roeCtomeocirtodiionnnasAtgaoerxnciy s Co E=H -2.-3Y
W1a2s0h1iCnognlsotni,tuDt.ioCn.A2ve0n4u6e0, N. W.
Ntaiiin NO cg,
Re: FTlSuCorAocSheecmtiicoanls8,(cD)oScukpeptleNmoesn.tal Notimcie:sSulfE onate SaE nd CarbToxyslic-basedsr
Dear Sir:
T3uMorioscshuebmmiictatlisn.g this notice to supplementits previous submissions on sulfonyl and carboxylic-based
c3oMmhmaesrcrieacelnltylayvarielcaebilveednotrhmeaelnpclooosleedd ahnualmyatnicaslerruepmortthawthwiecrheppruerscenhtasseddatbayftrhoem33M6 Elontvsiorfonmental
Labor
using
atory and
a protein
psruebcsipeiqtuaetnitolnytseccrheneinqeude
for
and
esncdroegeennedoufsorfsliuxotreoecnhedmiifcfaelresn.t
Each sample wasanalyzed
fluorochemicals, including
upesrifnlguloirqouoicdtcahnerosmualtfoongartaep(hyP/FtOaSn)d(eCm4mFaSs0s5s)pecatnrdompeetrrfylu(oLrCoo/cMtSa/nMoSic).aciMdu(cPhFoOfAt)h(eCd;aFtsaCpOreOsHe)nt,ed in
chothenelmyirceapanoldrstnawortaesnoerdceewrseisrvaereidlpfyrroroedmpurceeexsdtebrnatypaot3liavMte.oedfItcnuhraevddegisetniaeonrnda,lsthphooepululeldvaebtleioocnfolnluseoivedrleo.rcehdNeoamtsiasclclaroelfetrnheipneogrdqteuetadelcisttroyeddata
ingfenoerrmaaltliyocnorroborativeofpreviously reported values and/or do not represent "substantial risk"
160 have any questions, lease do not hesitate t contact Dale L. Bacon at (651) 7784736,
Sincerely,
TE
Hokie CR. Katherine D. Reed, PhD
SEtnavfifrVoincmeenPtraelsiTdeecnthnology and Safety Services
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BEST COPY AVAILABLE
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-------------------------------------------------- suEnvROmE[NTArL UBiORATdORY
3M
NO TSCA CBI
Analytical Report
Revised August 12, 2005
Initial Quantitative Screening of Commercial Lots of Human Serum `Obtained in 2004 for Endogenous Fluorochemicals Using Protein
Precipitation and Liquid Chromatography/Tandem Mass Spectrometry
Laboratory Request Number: E05-0120
Testing Laboratory
3M Environmental Health and Safety Operations
3M Environmental Laboratory
3M Environmental Laboratory
Project Lead
Mark E. Ellefson Building 2-3E-09
PO Box 3331 Saint Paul, MN 55133-3331
Phone: 651-778-5405
Testing Facility Management
`William K. Reagen, Ph.D. Building 2-3E-09 PO Box 3331
Saint Paul, MN 55133-3331 Phone: 651-778-6565
Requestor
Dale Bacon Building 2-3E-09
PO Box 3331 Saint Paul, MN 55133-3331
Phone: 651-778-4736
Pagetofs 2
--_--_--m--
3M Environmental Laboratory
WM ENVIRONMPERNOTAVLELCNAOTBOERvAToOrReY0
Analytical Report
ProjectNumber: E05-0120
The following analytical report presents data from commercially available normal
`pooled humanserumthatwerepurchasedbythe 3MEnvironmental Laboratoryand
subsequently screened for endogenous fluorochemicals.
`Thirty-sixseparate lotsofpoolednormal humanserumwereextractedusing 2
protein precipitation technique and screened for sixteen differeat fluorochemicals
using liquid chromatographytandem mass spectrometry (LC/MS/MS). Serum
samples were received from various suppliers between 9/9/04 and 12/2/04. Samples
were analyzed between 02/03/05and 02/09/05.
.
`This range-finding study was designed to provide lower limitsofquantitation
(LLOQs)ofapproximately 100- 300 ppt. Upon reviewofthe data, it was discovered
thatmanyof tetargetanalyteswerepresentatconcentrationsmuch lower thanthe:
100-300ppttargetlevel.Asaninterimsolutionanduntil a moredefinitivestudy
canbecompleted,signal10noiseratioswereevaluatedand alimitofdetection
(LOD)wasdefinedforcachanalyte.Asa result,calibrcuarvtesiwoerne
extrapolatedbetweentheLLOQandthenewlydefined LOD,allowingscreening.
qualitydatatobedeterminedforsome&-alytesaslowas 19.9 ppt. Thereforie,t
`mustbeemphasizedthatmuchofthe di presentedinthisreport wasderivedfrom
extrapolated curves andshouldbeconsideredasscreeningqualiydataonly.
Sampleresultsare summariinTzabeled1. Theaveragevaluesreported represent
samples in which there was detectable analyte. Sample values that were less than the
limitofdetection were not included in the average value calculations. Please refer to
Section 5 for individual sample results.
Page 20018 5
eet
[--E ----Y-- Tale. Summaroyf Prunes Aca Rests
3
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|wen [os Jem[weJoo]aon|vos[ow [om aco)
|e Sintsobweaten To3s17e TosseesrTwnimoss T[aaomsmoss[e [lo30e8r43e Te ossmrsriTaaaeroTToasszoieToToox"noep]]|
Number of Samples with.
Ne Detectable To Analyte vi To 7BCl
mee Ne R=NotReported.Thisnaiytewasdiced fe aoseofthe 36samplebutIappeTars obe 8contuminantof
Taba. SommaryotterSena ad oyFmdArataRass
fW ies Semrsei noTRoToosnimC n l[ooN omwmswT llssaeRrr[|1a6S3o soT|ae accooe [Toomme ee|] [ [[l e San n womizion TT|dno<ooTToaosrosieaTlaooomaueal]uostaeroiaiT2sl6e77s1o||noSiooo"osn |ooavocasemler]||
Lo s os |e 0n %|m am[e0e |n 3030|3008|r oo|asco|
`iPeakss wfeooreroPbmFsOerSevaendidrnPtFhOseAc.hrRoemlaattoigyrsabmrascnocrhredsapnodnldiinnegatroilsionmeearrraantdiobsrawnecrheed
determinedforbothanalytes andarepreseatedbelow(thehumanserum value represeatsanaverageof %branchedisomesforallofthehumanserum samplesthat
contained detectable levelsofeach analyte). "The % branched isomer results for individual samples are presented in Table 12. In addition, well-characterized lots of PFOS (Lot 171)andPFOA(Lot 332)wereanalyzedtogetheras amatrix spike
`(bQrCan0c5h0e2d0a3n-d0l0i4n)eairnirsaobmbeitrdsiesrturmi.butDiaotnaafnrdoamgrtehaetsawneallylswiistwhapsreevviaoluusaltyeodbftoarined
NMR data.
-- *
------------------
a EWROWE[ NTAL= LABORr ATORY
Table 3. Summary of PFOAand PFOS lsomer Ratios:
ERT i
Bodom
LFefllioieoes THe ER ea n | ed T
| HumanSe | umea % v| easg n e|
| LM6taT3tC5rR2i.x(1NS2Mp3iRk(ce0h(9aQ0Cr300a53c002t)0eP3r.F0ivO0azA4le)ude| ) 23% | mm |
Lot171 (NTMCRR.c6h9a6PraOcStaivazlaued
pron
Table4, ReferanceSubstances
CE [m [aanm|e owmn ] FheaeesRE EEB imaatse
Ta
ataona l
[F ibrae r |ronan|CEms |roIm [om| L omS|
|tonstsoopmamicrca |veraccsrce | wan |rorsmomino |ew| ome |
|returbemicnsd | princorn)|Odowootpris| tenam [sie| oom |
|rites| EACTAGH| Aas | toras |max| em |
|[rroemedrnoessss||rroornecisan||owewrw [|remmoawrnno[[osoonc||oemm ||
[Fooseatuoniecmoicsia[cloaca |osbvootprs| one |morn| ome |
|retonieomionid| Citas |ouvendpris| toa |sen| om |
|Pesoiuicamiensd| CizAed |OdoodPres | TcRsicoon [man| wom |
[roto
| moh| ow |torsion [moon| oon |
[retmosmmtiomse | vosa | ow [cramomian[ween| om |
[Creme | ps| ow [remo [se| os
[Cretosemntone wes | ow |monewe |wer| on|
|reboHrEceenitoss
pos| ow
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toes [we] ew |
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Page dof18
v WMENVIRONMPENRTAOLLAUNBOOEER0A5CT0O1RT2Y0
`Thesamples for thisstudywere prepared as follows: 1. Theserumsampleswereallowedtothawand warm toroomtemperature. 2. O1n5emmLillsiclrietewr-ocfapspeerdupmo(loyrpwraotpeyrliennetcheenctarsifeiosgfemteubteh.odblanks)wasaddedto a 3. Matixspikesandmethodblankswerepreparedbyspikingtheserum (or wsuartreorg)atweitthotahlelsanearluymtessaomfplientse,rceaslti:brIantaidodnisttiaonnd,ar'd'sC,PmFatOrAiwxbalsaandksd,eadnads a ``mmeetthhooddbplearnfkosramtanacceoncentrati.onof3.01 ng/mLtoevaluate extraction 4. Twomillltersofacetonitrilewereaddedtotheserum andthecentrifuge tubeswere cappedandvortexmixed,allowingtheserumproteinsto precipitate.
5. Thetubeswerecentrifugedatapproximately
theprecipitate,
!
3000ro
for20minutes
to
pellet
-
6. Afterremovalfromthecentifige,thesupewrasntraanstferaredntotan antoforvanialaysils.
t`aQnuadnetimfmicaastisosnpweactsraocmceotmrpyl.iTshheefdoblylhowiignhgppearrfaomremtaenrcsewelirqeuiudscehdr:omatography
Liquid Chromatograph: Hewlett-Packard Series 1100Liquid Chromsiograph
system
i
AnCaollyutminctaelmcpoelruamtnu:rKee:3ys0toCneBetasilTMCi;2x100mm, Sumparticlesize. StopTime;20.0minutes Flowrate: 300 Limi IM njeco tiopnhvbaosleui cmoer:il p5opnLee n.ts: SolveatA:2.0mMammoniumacetateinASTMType I water SolventB: HPLCGradeMethanol SolventGradicat:
_
I0me0 u0s%
10 2%
u1s5o0 wooonn
20500 220%%
Pagesof1s
6
---------------- eee-- ee ------e --e-- e--~--
WEIROENR TALC LNABOOERT A0T1OR0Y
MSoafstswaSrpee:cAtnroamleytseTMtr:VeMrDsiXonS1c.i4ex" API 4000 Q-Trap Mass Spectrometer Detector IToenmipzeartaitounrMeo:d4e5:0EleCctrospray Negative Gs1:35 Eanst2r:an4c5e Potential 10 `Analysis Type: Multiple Reaction Monitoring (MRM) Table 5. Acquisition Parameters
ase ni [[PrEAGoec)| 2130 |
1689 | =|
2180
= |
[PFHAGooa) | [TOHAGAG)|
3ia0 | sertws | ds es |seresaies| 5
| |
|ProAGiAs)| [CAd |
410 sao
|sesezisnteso | | wwrosozies |
40 ow
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-
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[pes [pros
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we | 0|
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| ams| sesms | see | sesso
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[ProaneTMs| aus | wes | do |
`qWuhanetnimfuylefaicphleatnarlayntsei,titohnesrweebryepmroonviitdoinrgedg,rteahteertsoetnaslitiiovnictuyrtrheannt.i(ndiTviwduaIasluQCsBedi)otno `measurements.
4.4 Calibration 411 Calibration Curve Alenveelxstarnacdteexdtcraalcitbirnagttiohneccuurrvveewiantshefsoarmmeedmbaynsnpeikriansgtrhaebbsiatsmpelreus.maSttporceksscorliubteidons w(eexzceepitndPiFviBdAu,alwlyhipcrehpwaaresdpfrrepoamrneedatinfMliulolrio-cQhewmaitcearlstoapnrdedvielautteedstienrimfeitcahtainoonlfrom "oTchceurmeignrge)s.siSonapalens weawraeslqpueanrytfiofrsiemdediveurssisunsga&nq8u-apdoraittiecxcturracvtefeidtcwaeliibgrhatteiodn1c/ux.rve.
1
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WMENVIRONMPENRTALOLAWJBOOEER0ASC0T1OT2R0Y
Ca(lLibLrOatQi)onwistthanadcaoerfdfsiwceirenetwoifdtheitne+rm2i0n%a(t4i2o5%n f0.o99r5.thLeoLwo-lweevreLlicmailtiboraftQiuoanntitation. sCatlainbdraartdison,wshtiacnhdwaredrsetnhaottwweitrheinnot2gr5e%a,tewretrheannottwiicnecltuhdeedmietnhthoedcballainbkrsawtieornecnurovte, included inthecalibractuiroven.
412 ContinuingCalibrationVerification (CCV) saAmCpolnetsi,nburiancgkCeatliinbgrtahteiosnaVmeprlifeiscwaittihotn h(eCCcaVl)ibwraatsirouncnuartvel.eaTsthoencCeCVevrerey c1o0 vewrays within$25%forallanalytes.
413 SystemSuitability
FainvdeasfytsetrtehmesluaisttabCilCiVt.ysTthanedsaersdasmwpelreesahnaaldyazreedabceofuonrtestwhietinhitaia%lRcSaDlibroaft<i5on%caunrvdea. rientsetnatnicoenst:ime %R of2S%wD hen evaluated independently exfocrtheefolplowting
Sseyvsetreamlsiunitdaibviildiutayltcrriatnesriiat.ioHnoswmoenvietro,rtehdefdoarttahreepCoirotAedciwdafsaidleerditvheedreftreonmtitohentime
`quantitationofthe TIC, which passed system suitability requirements.
-
Allofthesystemsuitabilityset forFBSAareacountsfled.The %RSDswere th6i2s%a,na7l.y5t%etahnerdef8o.r4e%t.heHdoawteavwera,snaocscaepmtpelde.shad areacountsabovetheLLOQfor 414 LowerLimitofQuantita(LtLiOoQn) `TheLLOQforeachanalyte wasequal othe loweststandardinthecalibrationcurve thatmetaccuracyrequiroef7m5e% -n12t5s%.
415 LimitofDetection (LOD)
t`hTahetLweOrDe2f-o3rctiamcehsaanbaolyvteetwhaesmeeqtuhaoldb0ltahneka.reacounts (convertedto a concentration)
416 Blanks
MethodBlanks
Allof themethod banksinthisstudyhadareacounts < 50%oftheLLOQ.
Matrix Blaiiks
`Twomatrixblaakswerepreparedin rabbitserumandanalyzedwiththesamples. `OnematrixblankcontainedendogenouslevelsofPFOSthat wereabovetheLLOQ. `An average endogenous valueforPFOS was determined by substituting a number equal to%the LLOQfor BLK050203-003
7
Page Tof18
-
SUENVIRONMPENTARL LNASO OOR0AT8CO5R72Y0.
Table 6. Average Endogenous PFOS Value Determination
EES
RE OCG
[ [e en wo os s | co |azos <s ouo eoo rao os s| |
"TrehsepoanvseerfaogereeAnnddvooggeeennroouuss PleOveSlsvoa| flPuReOwSaisnursaebdboi0tscsoerrrusemc. hemalri|xspike.
417 SolventBlanks
ATcesesttohnainil%etbhleanLkLswOeQrienaanlallcyaszeesd.throughouttheanalyticalrun.Analyteresponse was.
418 Surrogate
`e1mx3atCtrrPaicFxtibOolAnanmwkesa,tshaaonddddpemedertfahsooramdsaubnrlcraeon.gkasAtlealttasoucarolrlnocsgeeanriteurmrasetacioomvnpoelrfeise3s,.0wc1aelrniegbwr/iamttiLhointnosetva2na0dl%aura.dtse,the
4:2 Laboratory Control Spikes (LCS)
-
Si ix Latbt hoersaatmoh prlyeCso.ntRroelSpsiwkeeurse(cLloCrSrte)cwtseerdfeoprreepnadroegdeinnoruasbblitseeroufvmaannaeldytaelnialytszheed
`matrix (where appropriate), and arepresentedbelow.
Table 7. Matrix Spike Recoveries in Rabbit Serum
\oorohoaent9 CCocoocsmoaoonen|"s30m0 | | cuwooan[ | twaa|
Sa isn
ocososons| ocassmsoos |
me rss
| |
10 ma
| |
wx | ew |
[ocosemsoos | 756 | m2 | em
rr
TT 0 TT
| TT
]
N\eAonCicoIns,o lboccmosmmormow|| sawe[ |c cucu a| |cwwma a]|
lioa=is3roml focososo | locosozosoos |
rr |em | ex | rz |_ms | tox |
A= Not Appeals ooosomage | m7|wm|
Pugesofts q
---
Table7. Mati SykeRecoveries aRabbitSer (conied)
EE
haer rHE i *
OgC E
Pe
WMENVROMMR ENTAL LABT OERoAsToOreRsY
p
EE Re
p= rR aatE : |
[ocosemsoea| ses | <uwoa | ma |
oa="taAtEogsmt[Ooocmoossaos0osn[|ve3ms || ceuacda| | wsam || [Cacusozosoos [vas-- | 72 | wom |
[ocosaosoos T 765 | oz | an | +rT
[eos][=woaT[wm]
LoPa=AsaCanTgm. [|OCcoecaonoan|| avems | | <wwoea | | ewaw || [ooomsoos | 705 | m1 | wow | rx
|ocoseasace| ves ToseTee | ------TT TT
OA; D [oooocsmamosone[ |a 32 | | <<uuooaa| | wwaa ||
Loa=1zngmt [|oOoCoUmS2e0o0o0s0|4|
786 | esa | ew |
vss[m | o ow |
wx
[acoso|e | m1 | ox |
[[oocowmmooo|1 z30o7 || zarwi || ewoww| | sm
a=
2
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LL =02O 97nQ om.|E QCOSO0B004[7e53s| Ae 75s | tom ||
[ocosasons| vss"1 taa | vox |
UAC.
[Foocooe smemmmoos rne [|t aamma o|r a3m1
T | e ox | wom
||
|
oqo nom.[|ocOocosMeeammsoonoss| vvsses | 7m22 | | wwomr ||
NA Not Applicable[ooosoasoos| 756 | 7as | vox |
Page9o18 Io
swEwROMESITALELsoARATSORY
Tale. MieSpi Rov RaceSrrGiset)
is Te
E
CE ERT RES
IBi
bd
To= momoon [sot | oor | wx |
B [oessmo oars| sor-- [-- ao--e ----|
[Toooseamsose| aor | 21s |ew |
I
iT 1
[ocmsomaoo| ses |3 | wo |
pa |OoO0RZ0 | am 1 sok"|
Lioamo3eanom.[|C= oacBwsOoRmmzoOmNs||--arees-- a | |--mae--asT--|--owxx ||
Tosmmme | am wT wx]
[Cocosomaoz| 28 | 2s | ex |
[IPiP' OON[Fooccossmemaamzooirss ||
ase
7s
|
|
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ten
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Tr
--TT1
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Loamv9neoms[CE C"oo=sosmmeoonn |T"aees T awTmeR | oomw ||
[ocostosoos| ves | mr | www|
er -- 1 rr 1
ocr| 00 Tan Torx |
al [ocososors | a0 | 2m | ow |
wwoaxosongmt|ocosomoose | me | me | ow |
Cocososoos | me | 70 | vox|
Fuge 0ar18
ll)
----
AT
WENROMERITAALsoSRATSORY Table 7. Matrix Spike Recoveries inRabbitSerum (continued)
LH
i
i
;
|
METIAE
J]
EEF
L0a-oI0sbsenoimt|o[ Cacweo ameseS T|EY alm iwes mT|ae "Y rmsso| esr omn]]|
[v "ocmsom [ms s |i113 sows_|
frie
ei
eT TT
10a~3h1d5norm. = o[coocuemamnssas || arveissw | seTr oanon|]
------/TTT
eros |Cosommmmsmono T|e aw m T omToonu]] am Uoawamonom|_oomemsoos| mg | eso |aes]
|"ocoseeovaoe [me | oes | ream |
Tr
ITT
110ama 0303noms.|= ocasmosane|e resSo e ry . | umm]
. | ocoscaoos| vas
|ocomensoo| e ew
| 75 | oem |
| rea |ie |
Fagetaris 2
ueROmERISTA EAsooRATRORY TLaobvleers8. PFOS Matrix Spike Recovery in Rabbit Serum, Corrected fo Endogenous
R EaE diE e eS etE TOTe rh R e [ocoaso2 ovannzaadoost||E s30m6||savwr| |_ooastseC | | 2z8m |senw||
cam 03 m _Ooszoatos[174| | aa | mmo| [ocosozoeans|77a | ms| oss | ma | oom| [ocosemaoos | 774| 781 | oss | 788 |
43 Accuracy
`The accuracyforeach analytereportedwas calculatedbytakingtheaverageofthe `matrix spike recoveries for that analyte. The results are presented below.
Table 9. MethodAccuracyforIndiviAdnaulyatels.
[prea | srw | | CizhAca| asx | [CneeA sox | | Fesa | =m | [preA" | eas | | FOSA | sex |
[Grace | sow || pres | =m | [proa | wax |[Peis | em |
[[csadd |=m [ | Pros| =sx | [CloaciaTM| sm | | THpros| eax |
O TT [CitT Acd|=m ||e wwros | =m |
4.4 Sample Related Comments "The extraction and analysisofthe samples was performed utilizing anon-validated `method. The matrixspikeresults, '3C PFOAsurrogate recoveries, and the extrapolatedcalibration curve(between theLLOQ and LOD) shouldbeconsidered
`whenevaluatitnhgeaccuracyandprecisionofthesample results.
`Tables 10 and 11 summarize individual sample data.
3
Fuge 2018
eee Table 10. Pafverinstd Acid Results
eee sueAsOSRALTOT RY
[RES o
RE
ARFIRE
ER
ae
Fe
CO
hy i SRE el rE
|
Fa ne Hen [messToso"| Loo|<to0|<ob|oser| vere | woo| oo| woo|
[ese [Tess
["osor |<o0| too | ob|481 Too| <00 [woo[op|7
| eer | | 228|
oo| <oo| oo|<0 |
woo | woo|
[CowesssTiTop[woo | woo|sw|tes | woo | aast | oo |
[owe[706 00 a00[0| ras| 14s| oo | soo]ao] [CaeosoTot T<00[900[oo|313
[ess T3321200[900|<op|4s
| 245| | +41 |
coo|oro| woo| oo|
woo | woo |
[wees T7408T"<00[00| oo|5 |1&2 | woo | woo| woo|
[omeTassoJ<o0[wo[sar[a1] 00300[soo] [masorsTer |ase| oo |oss|sst|te | woo | oo| woo|
Pe 13018
1#
Table 10. Perflucrinated Acid Results (continued) SuEmRONMEE NTALLisi ORATORY
PROBE
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Page 14018
11
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ENVIRONMeENeTAeLLABOERAoTnORsY
Table 11. Sample Results for Additonal Pefluorinated and Highly Fluorinated Ansytes
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Page1sotis 16
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Page 170618
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Page 18018
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