Document bygz9rBndwOwXL4dwqBDwNjMo
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Analytical Laboratory RepSotrtudoyn PTritelseence and Concentration of Potassium PerfluorooctaneEsuxlpfoosneadtetoinPSFeOrSumviaanGdaLviavgeer of Sprague-Dawley Rats
REPORT AMENDMENT NO. 1 Amendment Date: 19 April 2000
Performing Laboratory 3M Environmental Technology & Safety Services
3M Environmental Laboratory 935 Bush Avenue St. Paul, MN 55106
Laboratory Project Identification ET&SS LRN-U2006 ET&SS FACT Tox-012
3M Environmental Laboratory
ccexzy
Report AmFeAnCdTmTeonNxo.t0.121
This amendment modifies the following portion(s) of the final report:
1.
FiNAL Make
REPORT: the following
addition
to
the
final
report
text
App:
sAtfatteerdtfhoer ftihnealanraelpyotritcawlasreifsesrueendce(ssiugbnsetdanacnedwaarschiinvaecdc)u,raittew. aTshdiissvcaolvueerewdatshabtastheed pounrliytyovnalue
pNuMriRty aonfatlhyesseess. Ssuubbssteaqnuceenst(cPhFeOmSicLaoltch1a9r3a)c.teIrfinzeacteisosnariys,octehuerfriinnagl rtoepdoerttewrimlilnbeetahemeacntdueald to
detail issued
the for
analytical results PFOS Lot 193.
using
the
purity
value
from
the
certificateofanalysis
when
it
is
REASON:
To describe is issued for
the changes that PFOS Lot 193.
wil
be
made
to
the
final
report
when
the
certificateof
analysis
2.
FINAL Make
REPORT: the following
addition
to
the
exceptions
list
in
the
Statement
of
Compliance
section.
Apo:
Tdheeteprumriitnyedanpdrisotrabtiolitthyeoifnitthieatainoanloytfitchailsrsetfudeyr.ence substance is unknown and was not
REASON:
The Statement of Compliance section was incomplete.
3. TFhieNapLurRiEtyPoOfRtTh:e analytical reference substance is 99.28% (Lot 193), as listed in Table 2.
AMEND TO READ:
The purity Reason:
of
the
analytical
reference
substance
(PFOS
Lot
193)
listed
in
Table
2
is
unknown.
The purity value stated for the analytical reference substance is incorrect.
4.
FINAL Make
REPORT: the following
addition
to
the
final
report
text
under
circumstances
that
may
affect
the
qualityofthe data.
Ap:
+ A8thc2ec5o0srMad,mineagnsdthoe8etth2,e5tDhMieluweteixortnerSaduiclmufmtoeardrF0yO.0vS0he1ermesLtaimtnhpteloee1x.8t01rma8Lc1s(M1f:ao1rn0dF00OFi),vbeiurvtsewaremspralemepcslael8c82u9l43a3t70e,dPua2ps44w1e2Mr0,e002d.4i5OtMen,d
Thh0i.ge0h0er1semtsLcualitlniftboorra18ti2.o4n09smMt.ainvd(ea1r:r1s0d00b),ybau2t0w%wm.aesrepqcuaalncltuilaaetteedd absas1e:d50o0n peak response that exceeds the
REASON:
To include the circumstances that were found after the final report for this study was issued.
3M Environmental Laboratory --
60130
Report AmeFnAdCmTenTtoxo124
5.
FOInNpAaLgReE4POoRfT1:6,a print compliance text with an
error occurred "X character,
twhiatthroeuptlaacneydcsheavnegraelinltinheesosfptahceinEgxbceetpwtieoennstthoe
GLP
subsequent bullets on the
`reApMoErtNDanTdOiRt EwiAlDl:archived
restofthe page. The in the study folder.
incorrect
page
will
be
replaced
in
the
final
The text
comect page 4 of 16 is lost in the print error:
attached
to
this
amendment.
The
following
lst
is
the
complete
+ SaTtiunhbeseidqmeunteeintytf,tshotreneensgtpuhrc,e,speuhrnitotyws,eavynedrchoempsoesiatrioonsdeefiwninhg tpheeterst eornconntreol aerticle ywas.nToodtdeetermined
++ rTFriuoonmgs1et5phStaerSpalmetmpbdearrd1e5oc5t8orunsnciwoe1rmteposabiregerne1d9816,0hhenprvotioocoalnwehs naot snpaorpsiopnrseof iacsttty,
++ +
DDDaaottvaaawtceoornneescnwtooetnrasvowaetyrsceantoosburatveaidysarphepceroonrvdeedidbaydtresreecspsonoysreiGcLtfooPrrarrsuersieecnursre,pdebydoGtLaP regussons
Reason:
aTsherefviinaelwepdribntyetdhreesptorutdywdiitrhectthoeriancnodrrsepcotnpsoargeredporeessennottatrievfel.ect the complete report document
Amendment Approval
Po: TG
`Marvin T. Case, D.V.M, Ph.D., Sponsor Representative
/7 dy. 1 omy
ate
A fer fh
Kristen J. Hansen. Ph.D., Study Director
04/19/e0
Date
3M Environmental Laboratory
cco121
P(oCtAaSsNsuimumbPeerr2t7u5cr8o3o6c3anesutrate
Lateratory 3ReMquEemsitrNounRmmeeepnertrat(lhLLoRaNbToHorUax2t00o10r28y
STATEMENT OF COMPLIANCE
Study Title:
AoncatlaynteiscuailfoLnaibaotreaitnoSryerReupmoratndLoinvPerreosfeSnpcreaagnude-CDoanwcelnetyr?atRiaotns oEfxPpootsaesdsitoumPFPeOrfSluvoiraoGavage
Study Identification Number: FACT Tox-012
t(ThhGeiLsPex)sctReuepdgtyuiwloaantssioicnnostnhdfeourbcuNtloelndeltiiendniclcoisamtlpbleLilaoabwno.creaItnwoiartdyhcSiFtiouoodndi,etashn[edDpaDrtreauseRgneAtqdusmiitrnueidsmytehrnaattssi)ob:neeG2no1oaCduFdLiRaeb(doPrraaertttorro5sy8p)Pe,crtawicivtteihlcye pebEryntviainnreoinnntmdeoenptteahnildseLsantbtuodqryuaiatlnoiartryycaahsnisvduearstaanptactrethiuecnii3pt.aMtlAiaundbgioctroapntrtororacycetadnuladrbewosrialatbnodreirfeeistnaadriienngehsdoffuoorsreaaudtdliwetisathsptedro1fc0ouyrmemeaenrtdsa,atTtihtohene 30 aEnnavlyitriocnamlepnotratlioTneccohmnpolleotgeydaantdthSeaf3eMtyEnSveirrvoicnemsenSttaalndLaarbdwOapserpatieng Prrociefdnuarco ecso.rrdanmceweithd3M
`Exceptions to GLP compliance:
bSattocrhagneumcobnetra,ineexrpsirfaotriotnhedarteef,eroernscteosruagbestcaonncdiet,ioPnFs.OS, were notlabeledwith name, CAS number,
* `Dseutbasitsanocfe,thPeFpOreSp,araarteiounn,knmoawxni.mum storage time, and stabilty properties of the reference
* Tathtehedetnitmleoy,fsttherensgttuhd,yp;uhriotwy,evaenrd, ctohmepsoesaitniaolnysdeesfiwneinrgetpheertfeosrtmoerdcoonntrtohlealrotticolfePwFaOsSnoutsdeedtermined
subsequent to the present study.
* Two separate study directors were assigned to thei vivo and the analytical potionsofthis study.
+
From during
15 September 1998 that me period not
unti 1 October in compliance.
1998,
the
protocol
was
not
sponsor
approved
and
was.
Deviations were not cansistenty approved by the studydirectoras required by GLP regulations.
* Data comections were not always recorded as required by GLP regulations.
+ Data were not aways attributed to the individual responsible for recording the data.
+ Records in electronic form do not meet the criteria set forth under 21 CFR(11).
+
Afinaized sample log-in documents did exist and
racking system were used to log
winaasnndottriancpkisaacmeplatest.he
time
of
the
study;
however,
draft
Proprietary and Contental
00132 Page dol 16