Document 70k393Z3Ex8pMJxEJgjwNJZEV
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ADIETARYLCS0STUDYWIrToHTsHENORTHERN BOBWHITE WILDLIFE INMTELRANABTRIEOQNUAELSLTTDN,o.PRO0J2E7C23T NO 454.103
S5r U0S.-BEanGlvc ioPrgoSnmeNnatiamlciPesr5T0eo2tc2G0Ad0gnecsy (a) FIERA SubdiviSesctiioon n71.,2 O5CDGitlin 205 AUTHORS: SCScooamnu.BrGeyaleClaessery Remand Van oven STUDY INITIATION:Apri 21,1599 STUDYCOMPLETION: Api26,200
AMENDED REPORT DATE: March 25, 2004
EmS3iUMBCMnomIoTrLsTaibTEoonDOr Ppaiimteysoenn5184
Wildlife International, Ltd. o[nr,rMy-- a 2160 0 zas00 Page 1016)
amen
600594
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WILDLIFE INTERNATIONAL, tT ES
PROJECT NO: 454-103
GOOD LABORATORYPRACTICECOMPLIANCE STATEMENT
SPONSOR: 3M Corporation TITLE: BFOS: A Dietary LCS0 Study wtiheNtorthhern Bobwhite WILDLIFE INTERNATIONAL LTD, PROJECT NO: 454-103 MLAB REQUEST NO: U2723 STUDY COMPLETION: Apel 26,2000 AMENDED REPORT DATE: March23, 2004 h"eThUiSs.stEndviwraosnmceonntdaulctPerodtienctcioomnplAigaennccey,wit4h0GCoFoRd LPaabrotra1t6o0ryaPnrdac7t9i2c,e S1a7ndAaurgdussatsp1u9b8l3,isOheEdCbDy P1r9i9n2ci)plsensdofJaGpoaondMLAaFboFr,at5o9ryNPorahcatinc,e,N(oOtiCfDiEcaItGiDonI(N2o). 3328,5E0,nvAigrronimuelnutraMlonPorgodruacpthioNno.Bu4c5a,sP,ris1,0 August 1984 with the Following exception: `GLAPttchoemptliimantceh;etheoswtewvaesr,cotnhdecuhcatresdctehretzaettiosnubwsetasncpeerwfaosrmneodt ccohrdairnga0cit3neMacrSctoiarnzddaaenrcddeOpweirtahtfilnlg PSrocuedubrewssaatnrdeasMheatnrhaocdctse,ieeadndinasllccroondwandcatewairteh GbLeiPngstmanadianradisnfeodllionwitnhgest3udMy carocmhipvteos.n.The test wa"sTnhoetstdaebtielirtmyinoefdthien taectcsrudbasntcaencweiathnGdoroefdeLraenbcoerasttoanrdyaPrrdaucntidceerSctoannddiaridosn.sofstorage a the est sit: accAonradlaynsceeswiotfh GliLvPersatndasneradanasdarrmepsdluelsstscofotnhdeuscteeadnablyyse3ssM.eCboeripnogrraetpioorntewdesreeparnatoelyp.erformed in
STUDY DIRECTOR: ,
SenN. aGaalla}gh.er 2 den Senior Biologist
pars 33oy
SPONSOR'SREPRESENTATIVE
KMhEmaTrAnnBeaach. [Deach
ote 3/24 Joy _
AMENDED
20595
WILDLIFE INTERNATIONAL, L0 a
PROJECTNO. 454-103
`QUALITY ASSURANCE STATEMENT
`This study was examined for compliance with Good Laboratory Practice Standards as published
PbryintchieplUe.sSo.fEGnoviordonLmaebnotraaltoPrryotPreaccttiiocne,Ag(eOnCcDy,E/4G0DC(F9R2)P3a2r,tE1n6v0iraonndme7n9t2,Mo1n7oAgurgaupsht N1o9.894;5,OaECsD,. 1992); and Japan MAFF, 59 NoSan, Notation No. 3850, Agricul Production Bureau, 10 August 1984. The dateofal audits and inspections nhed dacs tht any findingswerreportedto the Study Director and Laboratory Managemwernts follows:
Activity "&TetAnSaulbysttiacnaceSaPmrpelping Matix Fortification F&eeAdnCaolyntsiucmaptSiaomnpling AsDsrayftticRaelpoDrtaa and BiroalotgyReDpaoratsnd Final Report ARmeepnodretd Final
DATECONDUCTED
April 2, 1999 April 2, 1999
April 27, 1999
Jy 7,8,9,1999
AUEISt26,27,30,31, 1999. Api 7:18, 2000
March 19,2004
STUDYDDAIRTEECRTEORP.ORMTAEDNATOG:EMENT
Aprl2,1999 Apilz2, 1999
Apel, 1999 Apil23, 1999
AIZLI99 May 4,199
1iy9,1999 Jy 16,1999
Augusta], 1999 September 13, 1999 Apel 18,2000 April 19,2000
Mah19.2004 Mach 19,2004
SanS.uCsolamann. Colman
Senior Quality Assurance Representative
DATE___3-23.04
AMENDED Gn0596
WILDLIFE INTERNATIONAL, LTD
. AMENDED REPORT APPROVAL
SPONSOR: 3M Corporion TITLE: PROS: ADietaryLCSO Study with th Noster Bobwhite
WILDLIFE INTERNATIONAL LTD. PROJECTNO 454-103 3M LAB REQUEST NO U2723
, STUDYDIRECTOR:
Ndr $ Blacher
Sean P. Gallagher `Senior Biologist, Avian Toxicology
CHEMISTRY PRINCIPALINVESTIGATOR:
2 Lan cIveNn, PHhY.D
Scien, Analytical Chemistry
REPORTAPPROVEDBY:
Cintta KtMsitcZhellNacht!
ManagerofEcotox Operations.
WilHdB.iNilxodn,.Fo = Dietor of Chemisty
Salo
Date
Biesass
Be23Hank oo) Bie yw
:
----.
AMENDED 600597
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WILDLIFE INTERNATIONAL, LTD
5%
PROJECTNO.: 454-103
`TOAF CBONLTENETS
TIEPM srw
E
GOOD LABORATORY PRACTICE COMPLIANCE STATEMENT... POE 2
QUALITY ASSURANCESTATEMENT...
rn PoE 3
REPORTAPPROVAL vss:FBS 4
TAOFB CONTLENTSE...
PUBS 5
THAGI mms ----------age
SUMMARY. s--" - nnn BOGE1
re
Page
OBJECTIVE.
-
nvm POE 8
MATDEWERA ssessssmmmmesimmm
cage
J SOAS --
s-- .
renPaPaggee 89
DLuEraoTtftiheToemns..m. m"
r e-- --
Crepeagse
f AEE De bhcnSm--mnmmasmrmemnmmmmm------------------------------------g 1
UALISTBERNIoG mmmnmrscommeamp--r--m--a--m--m--m--m--m--s--m--s------------------tT0Y}1}
A
-- > >.1
Co OSTA t memmammmmmmmms--m--e--m--m--o--m--a--m--a--m------I 718
SHEA A wnmsermmsrmmmmmmm--------------------
RESETS mmmmmmmmmommmsnsmmm---------- EAS
a `MoandrCInitcalOaBSErlvaiOsns --------r----r----r------------------ PGE 1S BGord08y8WNeCiIgOhPtSYa.ndFeedConsumpion....... - m--me-- so g Page 17
CONCLUSION..........
wn
wo
on POE 18
REFERENCES .....
win
S------ 1
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WILDLIFE INTERNATIONAL, LTD
.
PROJECTNO.: 454-103
TAcOoFBnCnOeNLTdENETS TABLES AND APPENDICES
TABLET; CSumyisivePMROrS i rom NoreBobwhiteAce icyToxic P20
TABLE2:
TABLES: TABLE 4
S Mean WBE EodRyPRWeY OiSght(g) rere fr aNo orthm em BobwhiteAcuteDietary Pgs Toxicity 21 NMeeaneFDeieadrCyonTsoumxpitinonS(obyiwridthy)PROfSro.m Northen Bobi Page GRrCoupDGiroasrsyPaTthoolrogyicaSl OybsewrivhatPioOnSs.romar Northeo r Bobwhc ite POGS2S
TABLES:
Cumulative Mortality (Estimated Cumulative Dose,mg/kg)from a Northem Bobwhite Acute Dietary Toxicity Studywith PFOS.................. Page 26
APPENDIX; CoifofcAtTeS ccc
Page
APPENDIIXE DekFomineFOG 28
APPENDIVX: DekPepin... Fog43 APPENDIIIXI: Analytical Methods andRESuMS...........cnvsvsmsmrsmmsssmsssssnsess PAGE 29. APPENDIVX: CuimlaDiivaerMyorTaolsiitybyPodnyfwiotmh PsRNoOrSther Bobwhiteen Page44 APPENDIVEX: RIndeividDualiBrodTyWoenigyhsS(9y)fwoimhPaRNoOrSt.henBobwhite Pg45
APPENDIX VII: N-oSFnehehdyeCrWosnEBsRuaPmwRpOthSii,oen (Agc/tebirredar/bsdyaTPyoer)nifrom a
enn Fog 58
APPENDIX VII: ChantoPgreots...
Pagel
APPENDIXX: Persone Involved 5 SO.
OE6S2
APPENDIXX: Revisd Study Surry: APPENDIXXE: ReposAGRA.
en og63 og68
AtenokD n0599
WILDLIFE INTERNATIONAL, LT 7.
PROJECTNO: 4sei0s
SUMMARY `SPONSOR: 3M Corporation TEST SUBSTANCE: PFOS `WILDLIFE INTERNATIONAL LTD, PROJECT NO: 454-103 STUDY: PFOS: A Dietary LCS0 Study withthe Norther Bobwhite
RESULTS":
The dietary LCS value for northern bobwhite exposed to PFOS was determined to be 220 ppm .. with a 95% confidence interval of 164 ppm 2.10 289 ppm ai. The slopeofthe concentaton-response curve was 7.005 andth chi-square value was 0.023. The no mortality concentration was 732 ppm ai. Based upon treatment related morality, signs of toxicity and effects upon body weight gain at the 146 ppm ai. test concteh nno-otbserrveda-<ftlecticonocentnrat,ion was 73.2 ppma.
TEST DATES:
Hat~Acpehl 12,1999 Acclimation ~ Apri 12:22,1999 Experimental Start April 22, 1999 Experimental Terminatio-n May 14, 1999
CNOONMCIENNATLRTAETSITONS: 0,183,366, 73.2, 146,293, 586and 1171 ppmai.
TESTANIMALS: Northern Bobwhite (Colin virginianis)
AGE TEST ANIMALS: 10 daysofage at est initiation
`SOURCETESTANIMALS: ~ W8i59l8dCeomInmteermcateiDornialveLu. Production Flock Easton, Maryland 21601
STUDY COMPLETION: April 26,2000
AMENDED REPORT DATE: March 23, 2004
mSaetecriAalppfeonldliowxiXngfstoudtyhceormepvliesteidonno,minal est concntations and elsbased upon the eanalyss ofthe test
AMENDED
610600
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WILOLIFE INTERNATIONAL,LD 5
rRomCTNo. ast103
This sty was conduted by WildiItNeTIRnOerDmUaiCoTnIalONLid. for 3M Corporation at the Wilde Tematins Li. avis tosslogy fcily in Eason, Maran. Th inf orion ofthe fst vas conducted from Apel 22, 1999 to May 14,1999. Ra daa eneried a Wild neraionl Lid and copy of the final report ars fled under Project Number 454103 in archives located on the Widite Iemaional Lid. se. The objciveof hisstdywes 0 evaliat tOBhJEcCTyIVoEfa st substance 0 the Northen Bobi (Cols irgiianss) administered through the i fr fv days. An LCSO value will bs calculate, itpossibe.
MATEARNI DMA ETL HOS DS
Envi"rTohnememnettahlodPsroutescetdioinn AcgoenndcucytiSenrgietshis85s0tudyEcaorleogbiacsaeldEfufpeocnts pTreosctedGuuriedselsipneecsifOiPedPTinS tNhuemUb.eSr. $50.2200 (1), Secon 71-2 of the Environment! Frofcion Agency's Regisuaion Guidelines, Pesticide Assessment Guidelines, FIFRA Subdivision , Hazard Balusion: Wild and Aquatic
Organisms (2); OECD Guideline 205, Guideline for Testing of Chemicals, Avian Dietary Toxicity
"Test 3) and pon ASTM Standard ESS7-87, "Standard Practics for Conducsing Subscue Ditary Toxicity Tests with Avia Species" (4),
"Test Substance
Wil"Tdhee tIetstemsautbisotnaanlceLuwda.sMreescteiifvieadtifornomNu3mMbeCsor4p6o7r5atpioonnonreOcctto.berTh2e9,te1s99s8bsainadncweaswaassswihginteed powder deifiead:FC.95 Lot No:217. The reported puiyof th est sbsance was 98.9%, with an xiao datof2008. Following est eminatin, the ts teri was reslyzd. Therss of cant indicate. tssubstancepurity of 30.49%.Allesconcenhavrebue iadojusntedsto Sreofrleecdttuhnedpeuraimtybireenpcoorntioeindonthse new Certificate of Analysis (Appendix I)". The test substance was.
"Th imal sander ws recived from 3M Corporaon on Jay 2, 1998 and was assigned Wide ematiosa Li. deifcaion mmber 4526 upon ei. The trl standar, granular
eeFloslsloowafinmg sttusdy coomo pletmione , the testof6m5a 5.twWae shtrieeXr chariamccta eriazl oed sinetaoccoYhrvdaenoceoeftwitehhGLamPdesitatndatordrs eaned thhee AwenoED
C0601
_--_--mmm_
WILDLIFE INTERNATuIDONAL, 9.
PROJECTNO: 454103
material, was identified as: 1H, 1H, 2H, 2H Perfuorooctane Sulfonic Acid, Chemical Absiract Number: 27619-97-2. The stanwadsastorreddunderambientconditions. `TreatmentGroups
`The test consisted of geometric seriesofseven est concentrations anda control group. Thirty northern bobwhite chicks were asigaed to the control group and ten northern bobwhite chicks were. assigned to cach of the weatment groups. The birds were soried by weight, then chosen indiscriminately from within each represented weight clas for placement ino control and treatment groups. The birds were housed in brooding pens containing five chicks cach. Nominal dietary concentrations used in his study were 0, 183, 36.6, 73.2, 146, 293, 586 and 1171 parts per million active ingredient (ppm a.) ofPFOS. The dietary concentwerraeetstaibloisnhesd based upon known onicity data and information supplied by the Sponsor
Esch group was fe the approtpesrtoircaonttoel diet for five days. During the exposure period the control group received untreated feed. Following the five-day exposure period all groups were. given untreated basal dietfo treedays. On Day 8, haofltfhe surviving treatment and contro birds were cuthanized and liver issue, blood, and bile samples were collected for analysis. The remaining. birds were fed basal ration unl Day 22. On Day 22, these birds were euthanized and also sampled for liver weight, blood, and bile. `DurotftiheoTenst
"Theprimary phaosfethis test and theidurations were: 1. Acclimation- 10days. 2. Expos-5udaryse. 3. Postexposure observation -3 or 17 days Test Birds
All northern bobwhite (Colinus virginianus) were 10 days of age and appeared to be in good health at initiation ofthe test. The birds were oblained from Wildlife Intemational Lid. Production Flock, Easton, MD and werehatchedon April 12, 1999. Birds ranged in weight from18 0 23 grams at test nition. The birds used in this study were immature and could not be diffeentited by sex.
noGo2
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WILDLIFE INTERNATIONAL, LT "10-
PROJECTNO. 458.103
A binds wer fromthesame hatch, pena-ndpchenaatyrpicdalyindistingushalefrom wild bids. Albirds wereacclimattoethde cagndifancilgis rom he day of batch uni iaon ofhe esi
`AnimTahlrDoiugehtout secimaton and testing all test bids were fod a game bird ration formulated to Wildlife Inematonl L's specifications (Appendix ID, The chicks were given a viamin supplement hee watefrom th daythywer hitched nil th tationofthe test. Wot from. the town of Easton public water supply, and feed were provided ad im during acclimation and testing. The binds esivendoformofantic medication duringaclimstion esting
`DPiretepaTrhaettiesotnsubstance was mine direc nto the ation. Mixing was done with a Hobart mixer (Model Number ASZO0T). Al dietary test concentrtions were adjustetdo 100% PROS based pon thereprted pity ofthe est substance. All dietary concentrations and the LCS0 value are reported 23 ppm a. in the diet. Nominal dietary tet concenrations sed in tis study were 183, 36.6, 73.2, 146,293,586, 117 ppmai. Append IV).
Dict`SSaammpplleisngof the test dies were cllcted to very th test concentration administered and fo confirm th sabi and homogeneity of the test substance in th dits Homogeneity of the test ssiuxbsstaamnpcleeisn ftrheomditehtewa1s71evaplpumatead.. bytesctoldlieccttiangrseipxasraamtpiloensafmroDmatyhe0. 18H.o3mpopgmena.eii.tay.i.satmesptldeisetwearned collcted rom th top, middic snd botom of th Ieft an right sections of the mixing vessel. The Homogeneity samples also served as verification samples. One verification sample was collected from the contol dict snd two verification samples were collctd from each emaning ratment roup a preparation an Day0. At the end ofthe exposure period (Day5),one sample vas collected fromthe control and two samples were collected from cach ratment grouptodetrine ibility of the test substance in he diet unde est conditions. The stability samples wer collected from feed remaining in th feeders aftr being a ambient tet pen conditions for fv days. Samples were ransterrd immeditotWeildye Intemational Lid analytical chemist:
0603
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ne WILDLIFE INTERNATIONAL,10
_
PROJECTNO.: 454-103.
AnalyTthiecalmeMtehtohdodused for the analysis ofth avian diet samples was based upon. methodology eloped stWideItcmaional Li. and cited "Method Outlinefor he Determination of PFOS in Avion Fe,
Avian diet samples were extracted with methanol. Methanol was adfodreeidse quantity of feed contained in a Frenchsuare lass bot. Boles wer cpped and shaken on a shaker ble, Samples were vacuum ler sing quali ies pope. Therese fd wsrind thc mes with methool it the Fst, The fe vas tasted o a volumetric ask and brought to lume with mean. As spproprit, samples were furor died wilh melbanol. Each sample then was dtd with S0%4 methanol: 50% NANOpure wate souion contin 0.100 mg 51 PFOS (tema standardyLand0.05% fom cid (v4)so the thy el within the calibration rane ofthe PROS methodology. A method Towchart is provided in Appi I, Figure
Concentrations of PFOS in th standards and samples wer determine byreverse phase high performance lid chromatography sing a Hewlet:Pckard Model 1100 High Performance Liuid Chromsogrph (HPLC) witha PekinEms API 100LC Mass Spestrometercuiped witha Pekin Eimer Trboloyrsy fon source. HPLC separations were achieved using a Keystone Basi Cn snlytical column (100 mm x 2 mm LD, 3 um poricle sie). Th instrument parameters are ummariced in Append, Table 1.
Calton sandads of PEOS repre ina S054 methane 0% NANOpure wate soto Consining 0.100 mg 4H PFOS (intemal sandardL. and 005% formic acid (vv), ranging in concentrationfom 0.00229 100.0457 mg a1. were analyzed ith he sles. The same and most prominent peak response fo PFOS was uilzd to monitor PFOS in all calfraton, quality cool, and study samples. No stempt was made to quay PROS on the basis of individual isomeric compacts. Linea egesion equations were generated sing peak are response ais (PFOS intemal sanded) versus the respetive concen ratios (PROS neal standard) of the albration sunduds. A typical alaion curve s preseied fn Append I Figure 2. The concentrationofPROS i the samples was dermined by substvuing the peak are response ios ino the applicable tna regression cquation. Represent on chromatograms of low and high albanstandards eerset in Appi I, Firs 3 and 4 respcivey,
610604
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WILDLIFEINTERNATIONAL,uo meoscriaso eins: a
he p`rTohdeumcettohfotdhelilmoitwoesftqcuaanttitiaotinon s(iLanOdQa)rdfoarnatlhyezseedan(a0l0y0s2es29wamsgset1at)1.a1n5dptpemia.i.lcualcuflaoterd oasf he mat lari samples (500)
Two matrix blank samples were analyzed to determine possible inerfrences. No interferences wre observed atoabove th LOQ during sanpleaulyss (Appendix I, Tble 2). An rfroce in the ocd speared t spss th ame retention ime as tepek of meres but i was wel below the LOQ. A representative chromatogram ofa mats bak is presented in Appendix 1,
Figure 5.
Aven dict was fried at 457, 183 and 1830 pm ai. and analyzed concurendy with the wsaemrpelneostocodemteertmionrtthheemmeeaannprporcoesdsucruaelsrreeccoovveerryyo(Afpp9e4.n7d%i.x IA,rTeapbrleese3n)t.atiSvaempchlreocmoantcoegntrraamtoifons mati onion is presented in Append T, Figure
An cxample calculation is presented for sample number 454-1032, nominal concntraton of 183 pps navi di. FttiVoglum:e: 210000%m DiPlRuOtiSonPeFaakcAtve:: 101035e68rmedteiin ce ol duton ctor nPaekaAlvSeaRntd:o P0e27k4A9ve: 13160 [Te-- Spe: 277397 Cnucre:s we0i0g1h5e9d415)
1 renin t+ PEAT Fig) x15Cons we
610605
_--mm
WILDLIFE INTERNATIONAL, LTD 3
PROJECTNO. 454.103
(02749-0x00.11080m9g).
ame
= 000923main
Not: 5. nemasda.
PROS gma mample + S POS (mg 841) at neuenEE Fin ns Vee ((1)0x DiiltnonPFaactor 000923x0200x 100 am
= 18sppmai Pere .oro Conceniionon.= I FEOSGIE mOL)inSsD aIple
= EE eo
HousingandEnvironmental Conditions During acclimation and testing, ll birds were housed indoors in bateies of thermostatically
`controlled brooding pens manufscured by Bescon Steel Products Co. (Model No. B35). Each pea had flor space that measured approximately 72 X90cm. Ceiling height was approximately 23 cm. Extemal walls, eiings and loos were constructedofgalvanized tel wire and sheeting. Birds were sorted by weight, then chosen indiscriminately from within each. represented weight class for sssgment pens. Each group of birds was identified by pen number and test concentration. Individual birds were identifi by leg bands.
During the testth average temperature inthe brooding compartmentof the pens was 38C 4 2C (SD). Average ambient room temperaturefo this study was 27.3C 12C (SD) with an average relative humidity of 31% = 14% (SD). The photoperiod (maintained by a time clock) was sixien Hours of ight per day during acclimation and throughout the test. The light source was fluorescent Vights which closely approximate noon-day sunlight. The birds were cxposcd to an average of
n0G06
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WI ILDN LIFTE ERNATtI_ ONA_ L, reomcros sseis .
proximately 139 fo of llinstion, Housing and husbandey practes wee based on guidelines
`established by the National Research Council (5).
ObDseurrviatnigocnslimatailboidns were observeddaily. Birtxhiiingschbaovoaorprhymsiacal yinpjcuarlylwyeoebsenrovteduseatd.leasFtotlilcoewidnalt.et Ainrietcioornd waansd mcaonitnianuiinndgofulntill tmeorrmailniattyi,ons,iganls obfirtdsitweyr,e 2d snare chavo,
AnimIanldiBvoidduyalWebiogdhytsw/eFiegehdtCsownesruempmteisonsed Days 15 and Day 22 fr al reining bis,
a th inion ofthe et, Averag fod consumption
on Day values d
5, i
D n
ay 5, and on the cxpasre
cpearcihodir(aDtamyesnt05g)rosunpdatnhde pthoesscosnpvolsrgsraowb.srvAtdodnipnearilo,d (fDeaydsc6o8n)suwmprteiodnetwearsmidneetderbmyinpeedn foorr
Days 15 determined
and 1522 for the remsining by messing the chang i he
ceament and weigh of the
convol bins, fed presented
Fd to te
consumption ws bis ove 3 given
peroiftoimde. Theaccuracy wastageoffedbythe bis,
offed
consumpio
value
may
hav
been
affected
by
th
unavoidable
Gros Nesey
SubjAectetd 0idsgohsstnieccropdsyi. nAhdedcitoionnsalf, vheresstwenrde awleibgihesdesndilnve satuhse,embilnot,ionndwbeirlee
werecollectedfom bits cuthnized on Dy the couosfthee dy
and 22, and when possefomthose that died during
`StatiMsotircaalliAtnyadlyasaeswre ante in he computer program of C. Sepa (6). The program ws
adevseirgangeedmteothcoadlcorulthethebiLnComSiDalvarluoasndatheme9t5h%odco(n7f.i8d9e)n.ce Iinnehviaslsbtyd,protbiet LanCaSlyOsisv,amsovwiangs
determined sing the prot method. Sondnes of fi est wc report,
The lopeoftheconcenzaton sponsecurveand esasofhe Body weight dota were compared by Dumnets test using
TOXSTATsofware(1011). No sasica antes were spl 0 cd consumption da.
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WILDLIFEINTERNATIONAL, LTO
PROJECT45N410O3 :
1s
RESULTS
---- Avian diet samples were collected from the 18.3 and 1171 ppm ai. tet concentrations and
analyzed 10 evaluate homogeneity of the test substance in the avian dit, The analysis of these Samples also served as verificationoftest substance concentrations. Resulting mean measured concentrations, sandard deviations and coefficients of variation (CV) for these test concentrations Were 19.5% 2.13 ppm a. (CV = 109%) and 1196 + 702 ppm 8. (CV = S879), respectively (Appendix TT, Table 4). Control avian diet samples collected ding th test shnooinwtereferdes above the LOQ. Samples collected during th est 1verifythe 36.5, 732, 146, 293 and 586ppm a. {est substance concentrations had mean measured concenetons of 402, 745, 174, 291 and 537 ppmad.,respectively. These values represented 10, 102, 119, 59:3 and 91.6%ofthe nominal concenratons, respectively (Appendi I, Table 5). Analysisofavisn die samples collected from oeder ft being held at ambient tmperstur or five days sveraged 101, 122, 104, 101, 109, 114 and 102%of the DayO valvesforthe 163,36, 72, 146,293, 556 nd 1171 pm a. test substance concentation, respectively (Appendix I, Table ). A representative chromatogram ofa test sample is shown in Appendix I, Fire 7.
One incidental maraity acer i th cote group din he coursofth std (Table 1 and Appendix V). On the momoifnDagy , ane bid was noted wibtrokhen leand was subsequently cutbanized on Day. Additionally, wobirds nthe control group wer intritentynotedwith foot Jesions sociated with cage mat aggression Otherwise, ll controlbirdswer:norma in appearance andbehavior rovghouthe test
No treatment ested mortals or overt signs of toicty were observed in the 18.3, 36.6, or 73.2ppmai. westment groups. One bind inthe 18.3 ppm ai. restment group ws ned3s lame fom Day 6 though Day 8, and blood ofundetermined origin was noted on the undersideof onebird rom the 3.2 pom a. treatmentgrouponDay 22. Osherise,al bids in the 18.3, 36.6and 73.2pom a. treatment groups wer normal in appescance and behavio throughout the test period
.
0608
WILDLIFE INTERNATIONAL, LD "16
PROJECT NO. 454-103
There was 11% (1 of9) mertality i the 146 ppm ai. treatment group, 80% (8 of 10) mortality in the 293 ppm ai. treatment group and 100% (10 of 10) mrtality in the 586 and 117) ppm a. treatment groups. In the 146 ppm ai. treatment group, one bird was euthanized on Day 3 ater sustainbrionkegn leg This incidentalmoralicywas not ued fn the calculation ofthe LSD value. Additionally, there was ontreatmentelated morality in he 146 ppm a.. wament group, @ bird found deadon themorningofDay 7. Clinical siofgtonxicsity wereobservedinthis retment group on Day 5, when two birds displayed wing droop. Al ober birds at this test concentration were normalinappeaarndabenhavcioerforthe durationof hetest.
Tn the 293 ppm .. treatment group thee were ighttreatmentrelated morals, occuring on Days 5, 6 and 7. Siogftonxicsity were first observed on the morning ofDa4aynd continued fo be exhibited through the morning of Day for he single bird euthanized on Day 8, and through the afermoon of Day 8 for the single bird surviving ul Day 22. Signs of toxicity included a ruffed appearance, reduced. reaction to simul (sound and. mation), lethargy, wing droop, loss of coordination, ower limb weakness and convulsions. The single remaining bird appeared to have recovered and was normal in appearance and behavior fom the aflroon of Day 9 until test termination.
nthe 556 ppm a.. treatmentgroupmerlewer frst nootnDeayd3an contintuoebde bserved through Day 7,atwhichpointsl birds hd died. Overt signs of toxicity were frst observed on the affemoon of Day 2 and continued through the mori of Day 7, when the foal birds were found dead. Signsofoxciy obsrved among birds in th S86 ppm... eatment group included fled appearance, reduced reaciontostimuli (sound and motion), lethargy, depression, wing droop, Toss ofcoordinaotwieolnim,b weaknes, lowe im rigidity, prosrate posanudconrvulesio,ns.
In the 1171 pom .. treatment group 100% mortality had occurred by the mornin of Day 4. Signs of toxicity i the 1171 ppm .. treatment group were first observeond the aftermoonof Day 2, with the fist mortalities noted on the morning of Day 3. Signs of oxiity observed prior to death included a ruled appearance, reduced reaction to stimuli (sound and motion), lethargy, depression, 1sofcoordination, wing droop, and lower limb weakness and rigidity.
670609
WILDLIFEINTERNATIONAL,LD Ra
rORCTNO:assis
`BodyWWheeinghctomapnadrFeedeodtChonescuomnptrtoilognroup,ther wer spp reatment elated ef upon body welght among bis in th 183, 36.6 or 722 ppm a. treatment groups. However, here ws a concentration espaniv eduction in body weight gaio body weight los i he 146, 293 nd 586 DPiPfMfera.ein.cetsrefatmeinhteocgroonumtposl dgurroiunpgwethree esxpoasureaperSiiogdni(fDiacyasant0-p<5)00(T5ablfeor2thaen1d46Appppmenad.ix vVIe)l. 20st p00 fr the 293 and 586 pom ai. eels. A snisicaly significant (<0.01) rducion in dyweight gin coniued obe cbscravehde146pmai. st concntraton trough Day ofhe Study. At the 253 ppm ai. consenation a sata significant (p<001) mean weight loss continued through Day8 ofthe study nd a masked roduction i weight gan was noted through Day 15ofthesty. Ductooamorabloidytweyig,htfectcould tbe determionrethd 1171 pom 3 evel during the exposure pericd or for the 536 sod 1171 ppm, ream groups or pos exposes prod
her wer 0 span eament elated fst von ed consumpion a he 183, 36.6, 73:2 or c1o4n6supmppmioan.i.watessttceondcentttrahteio2n9s5,(T5ab9lea3ndan1d171Appppenmdiax. VtIrIe)a.tmeHntowgervoeurp,s ra irnedguctthieonexipnosfuereed period (Days 0:5). There were no eamenteae fects on fed consumpion fn any of the Suiviog samt groups durin th Day 68 postxposure period. Inte 293 ppm ai. vesment ar.outetocononcnebnyiartdonsuurrivngib0voDteahdyth2e2.DaTyhe1e5ducanidon15in.2f2pedossonxspuomspionpoebrisoedrsvewdaas tthhee 2e9l3tppomf having any ane in inthe es, and was otconsidered ob reams ele.
`GrosDsuNreicnrgotphseycour of th est, all bids that did were subjected 10 8 gros necropsy. Necropsy ress for bids found desd were smi, Common absrvtions included thin condi, 10s of muscle mass, aired spleen color, autolysis of sues and pale organs. Details of the necropsy ndingsar prsentodin Tabled.
Halfofhe surviving birds ers subjected 10 gros necropsy on Dey 8 and the remaining beds were neropsied on Day 22, followin tst trminaton. On Day , on bird inthe 73.2 pom ai resent groupws td with lig pal vr. Dus othe soled natureof his fining, was
600510
WILDLIFE INTERNATIONAL, LD ise
PROJECTNO: 454-103
not considered to be related to treatment. The single bird uthanized from the 293 ppm ai. treatment grwaosobuserpved at ncropohsavye witha lackofmuscle mass andgeneralthinness. Sin these: findings comelated with an impact upon body weight noid at his concentration, th findings were considered to be treatment related. Necropsy resus wre unremarkable for all other birds euthanized on Day8. Similarly, Day 22 necropsy findings were unremarkable oral birds.
CONCLUSION "The dictary LCS0 value for northern bobwhite exposed to PFOS was determined to be 220 ppma. with a 95% confidence interval of 164 ppm a.. to 289 ppm ai. The slope ofthe concentration response curve was 7.005 and the chi-square value was 0.023. The no mortality concentration was 75.2 ppm a... Based upon rcatment related morality, signsoftoxicity and effects upon body weight gain at the 146 ppm ai. a test concentration, the no-obscrveds<ffet concentration was 73.2 ppm a.
670611
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WILDLIFE INTERNATIONAL, LT "19
PROJECT NO: 454.103
REFERENCES
1. U(.dSr.i)E,nOviPrPonSmeNnutmablePrro8t5e0c.t2io2n00AgAevnicya,Di19a9r.ySTeorixecy$5T0os-tEcologia EffTesetGucidetlinses 2. USEunSbv.diirvEoinnsvimioencnoanEl.mPernHttaeazolairoPdrnoAtEfevecaltauieaoytn,ioOnA:gfenccoyW.fiedls1f9ce82i.nedrPoeAsgtqaiumcaistd.iecAWsOaerssgshamgeniniot.nGuDiS.dbCesliencesso,nFI7F1R5A 5. OTersgta.niOzEaCtDioGnufiodelEinceonoormiTecstCiongopoefCrhaetmiiocnalasn.d DGeuivdeelloipneme2n0t5., P1a9t%s. Avan Dietary Tuscy 4. `AASmSuebTarcMiuctSaeanDriSdcoaacrriye,tTyVooilf.coirt11yT.0eT4s.etitnPghwiiatlhndaAdvMeialtserSPipoaclisc,s. A19S87T.M SSitnanddaarrddEP65r8i7c.e AfonrouCsotnBdouockinogf 5. NWaatsihoinnagltonR,esDe.aCr.chNatCioounnaclilA.csd1e99m6y. PreGsu.ide12f4oprp,the Care and UseofLaboratory Animals. 6. SCtoemphmains,sCiLEo.n 1978. US. EPA, Environmenial Research Laboratory,Dulth,MN. Person 7. SHPtaeazpahcradhn,aECv,aEl.uPaot.1i9o7n7s., MAmeriecanf.torSoCcahilectlyatoifnogrdaTnesLtCsiSn0g.sFnadgMsa5t.e94sI.n Aquuabt.ic NToo.xicSoTloEgy6a5n4d 8. Finney, D1. 1971. StaMetthodssiniBllcoicaalslsa, 2nd. GriffinPres, London, 5. Thompson, WR. 1947. Bacteriological Reviews,Vo 2, Noz: 115.145 10.wiDulmCaeotn,eCoWl. Jo1u9r5,5.AmeAr.MuSlati.pleAsCsoomcp5ar0s:n1'0s96P1r.3o1c1edureforComparing Severs Treatments 1. Gulley, DD, 1990 TOXSTATRefs 3:2.To UniveofrWysoimitngy.
6n0612
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WILDLIFEINTERNATIONAL,10 = phoseeraosso:s
TABLE| Cumulative MorfaomlsNiotoyr Bowie Ace Dicary Toxicity Sudy ith PROS
En
Toros Fores
owBiFos
= Grmai) ORO BRT wT AwT BTC BT y owe DT DT
Conet
.
wo wo ow om om we wo wo um
Treament ws 306 na
oo mo ow wo mo oo ol m0 on ow wo ow ow on wo wo wo aw
wo on mo wo on ow oo om wo
146
BY
10
wl
0
or
00
om
10
on
09
ow
0
20
09
wo
w"ow
w"wo
st
ol om om wo wo so wo wo
wn
ow om on wo wo wo wo wo wo
d TTT Eiy hT ayyRT ee mae eT eT
610613
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WILDLIFE INTERNATIONAL, to La.
PROJECT: 454103
TPAaBgL1eE2 MeanBody We8i)frogm aNhorthtern Bobwhite Acute Dietary Toity Study with PFOS
"o-e_rm--o y
eExpoenueporng
Day0 Days Day0s
PostExposeGPoensieod Toul
Day8 Day 5:8
Change'
ContTrol kMyem 2Tomnw s x HI s
i
Treatment
wo MBye owTh ws u ws2
3
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6 5Mem 2ToTae ae Lo oo
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SOCaRldyn y Ba centot thomeoeira)mtgroo tp<00005 Dv oe's s)
6n0614
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WILDLIFE INTERNATIONAL, LT "z-
PROTECTNO; asa103
TAPBagL2eE? Mean Body Weigh (9) foNortmher Bobwhite Acute Ditry Toxicity Sty with PFOS
TEroer
--_--
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Dus Duis Dutis own pein ows
Cou"rt Moe weoh on3
2i 23
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V Smsd in opa e coiy pap 005 ous
600615
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WILDLIFE INTERNATIONAL, (10 a.
PROJECTNO: 454.103
TPAaBgL1eES Mean Feed ossurmpion gToixdiidtyyS)tudoymwiatNhorPEtGhSe.r Babi Acute Dicry
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u u i 0 ' .
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_----
WILDLIFE INTERNATIONAL, LTD
a.
PROJECT NO.: 454-103
TPAaBgLeE? 3
Mean Fecd Consumption (Tgobxiircdi/tdyayS)tufdryowaimthNoPrFtOhSem Bobwhite Acute Dietary ------
(pGprmouaps)
PostExposure Period
E CC r
--
o sDMe.an
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51
Treatment 183 366 n2 146
ES ss un
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ST WILDE LIFE TITNETRERNNAATTIIOONNAALL,,oLD E'S
PPRROOKJECCTTNNOO.:d4s5a4.a1003y
Group GroTssAPBaLthEol4ogical Observations from Norther Bobwhite Acute itary Toxicity Study with PFOS
Birds that died duringth course ofthe study
PEMArr
Finding
Cowl TW HE mI T
_
MNeit NNw2 NN%= NNeewo NNeeoo
AAbbddoommiinnaall ccavviityy,, asuotmoleysaitsltyhsriosughout
o o
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o o
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o 0
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0 o
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0 0
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small
nd
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0 0
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10618
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610619
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WILDLIFE INTERNATIONAL, LTD
-27-
PROJECT NO.: 454-103
Certificate Of Analysis
ies, 00 FC-95, Lot 217
Pp urtas ont srtonnctr rem. re
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GR0G20
WILDLIFE INTERNATIONAL, LTD "ae
PROJECT NO: 454-103
APPENDIX 1
`WILDLIFE INTERDNIAETTIFOONRAMLULLTDA.TIGOANME BIRD RATION'
INGREDIENTS FSWihoneeaBCteoaMmnidMMdeesaall, 48%Procin PArgocaiyn BSpaesceial, 60% Protein `DArTied WMheeayl,20% Procin GEMeartsohtuimnoadnniLnCieamlerPshteoosnie + Liquid VGSiaLtlaFlmeoidrnimzae(ndFdeMrimnaetrcaol)Premix se below) Toul
PERCENT (4) a36055650 0000 320500 000356s00 0023i5r} Woo
VITAMIN AND MINERAL PREMIX
AMOUNT ADDED PER TON
`Viiaamiinn ADy RNiiPbaaoncftioltnahveinnic Acid VFoliicmAociBdy BiPoytiidonsine TVhiiaammiinneE VMiatnagmainneKs(eMenadions Dimethypyrinidine Bisuic) CZoipneper ToiSdeoilnenneium
270000000000011C.U. 0160 gggrrraaammmsss 008 mggss 12megsums
200010210grams 10528grgarmasms 47Eggraamsn 1581125gmrgagamsms
ThoefgSuharcarnutdeeedfiavnear.lysis i minimum of 27% proc, a minimum of 2.5% crude ft and@ maximum "Fementaion By-Products (Source ofUnidentified Growth actors).
C2622
_-- 9. WILDLIFE INTERNATIONAL, LTD
PROJECT NO.: 454-103
APPENDIX II ANALYTICAL METHODS ANDRESULTS
6noG22
_--m----
WILDLIFE INTERNATIONAL, LD 30-
PROJECT NO: 454-103
INSTRUMENT:
ANALYTICAL COLUMN: OVEN TEMPERATURE: sToPTIME: FLOW RATE: MOBILE PHASE: INJECTION VOLUME: PROSRETENTIONTIME: IRENTTEENRTNIAOLNSTTIAMNED:ARD. PFOS MONITORED MASS: _MION--TNEIRTNOARLESDTMAANSSD:ARD
APPENDIX Ill Table 1
Typical LMS Operational Parameters aTTPueerwrbeokrli-onPnEaSlcpmkreaaryrdfAoPMnIosod0ue0rcLe1.C10MO0paeisrsgaShtpeePdcietnfrsooermlmeeatcnteicrveeeqLus1ioqnpupmdeodnCihwtriootrmhimnagmPomegokrdiaenphEwlmier (SM), Keystone Beasl Ci cour (100 mum x 2 mun LD, 3 um patie size) soc 100minutes 0220 mUminse 72.0% Methanol 28.0% NANOpure Water containing 0.1% Formic Acid 200 Approximately 7.0 minutes
Approximately 48 mines 498.6amu 267 am
C0623
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WILDLIFE INTERNATIONAL, LD
re
PROJECT NO.: 454-103
APPENDIX Ill
Table
Matix Blanks Analyzed Concurrently During Sample Analysis
giNsea-m1i0e3:)
eee Tipe
mePROm S! e Gpmai)
MAB-1
`MatixBlank
<iq
MAB2 TihnealyT2o2dto(F0q00u22a9 nmgto1()LOaOn )
Matrix Blank hwaesi1a7i5nptpo1 obfatsheedmpoan
5bapsrsoadmpsleosF
<1oQ T50e0)owes caries
Samed"
:
60624
WILDLIFE INTERNATIONAL, LTD
-n-
PROJECT NO.: 454-103
APPENDIX TI
Tables
`Matix Forifcations Analyzed ConcurrentlyDuring Sample Analysis
T `Sample Number em omT as percent
(asa103)
Fortes
Messed
Recovered
MMAASSIAA
ias5
iasnt
5103s
MMAaSASS2
ji1
171662
98631
MMAASSSS
11583300
11m 576
396317
`Sundard DeviVtiieown ==
E69R0
oNv=e
2358
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610626
Gn0G27
.
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C0629
29630
WILDLIFE INTERNATIONAL, LTD
ER AppENDI1X
PROJECTNO: 454-103
10
10 aan:1995 on
o
o
7
o
5
"
a 2
as
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Figare3. A rprscttie on chromtogamof sowevel (100229 m 1/1) FOS sandrd 610631
WILDLIFE INTERNATIONAL, LTD
9APPENDI1X
PROJECT NO: 454-103
to
188 onal: 26054cps
o a 7 & 5 "
Ls
2 '
9 28T Tw 4e 8 2%k
144
eSrm Juszse issTw
A7B719020a4sl_ie 230 Tseaen
Figured. A representative ion chromatogramof a high-level (0.0457 mg a.i./L) PFOS standard,
-
620632
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WILDLIFE INTERNATIONAL, LTD
~0APPENDIiXt
PROJECT NO: ds4103
100 wf a a
0 s0 50 "0
. 180 ntoe25t0yc:ps 100
as
4
i
216
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TToET3s eSTn TGak iGeR RTeaiwm STaene
FiureS.A"rTehpraersreontwaitinvdeiccheomtshettoegnatmioofn ime oifxPbFaOr.ksale (454-100-MAB-1).
Gn0533
WILDLIFE INTERNATIONAL, LTD an
APPENDIX 11
PROJECT NO; 454-103
To
188 Intensity:6238cps
s
8
7
8
5
4
3
144
2
1
o
24 317
e191
122 151 151 181 211
Scan
1% 25% a; 50s 632 757 683 Time
Figure6. Arepresentativechromalogram of amari fortificationsample(454-103: MAS-LA). 670634
_--mm--m----
WILDLIFE INTERNATIONAL, LD
-aAPPENDIIXt
PROJECTNO: 454-103
-
187 ntensty:7248cps
o
8
7
s
5
4
s 2
145
'
24
123
7 220
S1%TE25% Taet8 asos a6s3t2 a755 esnss Smne
Flare. A representative chromstogramofa es sample (454-105.2)
C0635
_--
NWITLDELRI=FNEAITNITEORNNAATLIO,NAL, uLT0o a.
DIEATPPPREENPDAIRXAITVION
PRPOROJJEECCTTNNOO:. 445544-110033
`Weight and volumeofconstituents use toprepare test diets:
ConNceonrtmraatlions | STubostrance | Raantiaoln
w1o83
018=18 8590909080
37626
00376328 5999993
124063
2L0615253 81999978.15
i586
L58e2i3s9 88998984.24
Diets were prepared as follows: #50000gofbasal ration was weighed into a tared Hobart mixing bow The test substance was weighed in aed weigh bot. `Appbrloexnidmerately 100gofbasal ation was aken from the mixing bowl and placed in a Waring
The"wittehttshuebrsitnasnecaelwsoasbeaidndgepdltc0etdheinlethndeblrenadnedr.the weigh bost was rinsed with additional ation, mTihxiebnogbwll.endTehrecobnlteenndtesrwwearse rbilnesneddewdiftohraadpdpirtooxniamlataetlioyn6,0wsietcotnhdesrainnsdetarlasnosbfeeirnegdptloatcheedmiinxitnhge.
bol
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620636
I
BEST COPY AVAILABLE
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10637
WILDLIFE INTERNATIONAL, LTD
PROJECT NO.: 454-103
ase
BE Grow pm 0
APPENDIX VI Individu`aAlcuBteodDiyeWteariyghTtosxi(cgi)tyfrSotmud2yNwoirtthhePrFnOSB.obwhite
Page!
Bid Dw Dw ChaDnwgOeS. Dwi CDhuansgse.
2' I2n 22
7s 324
73
35 22 22 1i0 wo2 05
Me5n 221 5 i1o6 E') 13
sD 2
4
5
3
-- Toul Change.
i5 2i1s zis 7
o
21 E1d 22s 75 338s 05
11s6
33 22 3 15 Fi3 05
27
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55 33
93
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s4 23
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a0
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3
i
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Gn0G38
WILDLIFE INTERNATIONAL, LTD
PROJECT NO.; 454-103
a6
APPENDIX VI
Individu`aAlcuBteodDyicWteriyghTtosxi(cgi)tfyrSotmudayNwoirtthhPeFrOSB.obwhite Page?
--Gro-- w
Change
Change Toul
gpm
Bird Deyo Days DwOS Ds Dn3 Che
o
:! 0m zx 79 33s6 57
11s
i 50wa 02 1n0 ": 22
2>
Me5n "_20 ED3 IiHo W"o 100
2Ts
5| 3 2 5 2
4
0
x1 o1as 30 1n 3 15
22
i 50a 0m 22 ni a5 55
0is
Me5 n _ I2 22 In0} a2 15
E2n
Gow
Mew 202 E2 02 35 i
33
Toul
so | 4 5 s 2
4
670639
WILDLIFE INTERNATIONAL, LTD
PROJECTNO: 454-103
are
APPENDIX VI Individual Body Weights g rom a Northen Bobwhite
Acute Dietary Pages Toxicity Study with PFOS.
--_---- Gfomin) Bit Duo Dus CDhaonsge pws DCuowngies cTmowe
10
Loew Tm .
1s
2 ow ow uw ow .
n
sow ow ow s
mw on won
PF)
som ow uw ww
P)
Me 5 Ti HAT4 Rs y2
3
13 Co
om sm ow
1
2 wom sw 5
1
sow ow som 5
1
som wu wow
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Men W 2 TER5T w 3 3 w ; 5
TToou
Vseor H i w 3 s :5
03
60610
WILDLIFE INTERNATIONAL, LTD a8
PROJECT NO; 454-103
APPENDIX VI Individual Body Weights (g) from a Northern Bobwhite
`Acute Dietary Toxicity Study with PFOS Paged
TEGroup
Change
Change: Toul
(ppm
Bid Dayo Days Day0s Day8 Days
Change
366
1 18 %
8 3s
9
"
2 1 30
n
3
9
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WILDLIFE INTERNATIONAL, 10 o-
PROJECTNO: 454-103
--_oGm--oew--) -- na
APPENDIX VI IndividunalcBeodDyiWceigThtoss(e) fSoomdayNworitheFrFnOBSobwhite
Peas
Bi Dye Dus OChwanegse ows oGuwnets cToeul
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WILDLIFE INTERNATIONAL, LTD -s0-
PROJECT NO: 454-103
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--_
APPENDIX VI Individu`aAlcuBtoe dDyieWteariyghTtosxi8ci)tfyrSotmudayNwoirtthhPeFrOBSobwhite
Page 6
Bid Dayo
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WILDLIFE INTERNATIONAL, LD
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PROJECT NO. 454-103
APPENDIX VI Individu`aAlcuBteodDiyeWtaeriyghTtoxsi(cgi)tyfSotmudayNworitthePrFnOBSobwhite
Page?
TeGeroup Gpmai)
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WILDLIFE INTERNATIONAL, LTD
PROJECT NO.: 454-103
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APPENDIX VI Individu`aAlcuBteodDyieWtaeriyghTtosxi(ci)tfyrSotmudayNwoirtthhPeFrOSB.obwhite
Pages
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_-_--
WILDLIFE INTERNATIONAL, LTD
Ls.
PROJECT NO.: 454-103
APPENDIX VI Individu`aAlcuBteodDyieWteariyghTtosxi(c5i)tyfSrtoumadyNwoirtthhPeFrOSB.obwhite
Page
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WILDLIFE INTERNATIONAL, LTD
PROJECT NO: 454-103
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APPENDIX VI
Individu`aAlcuBteoDdiycWteriyghTtossi5ci)tyfiSoumdayNwoirthhePmFOBSobwhite Page 10
E"Grou--p, ----
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WILDLIFE INTERNATIONAL, LTD
PROJECTNO.: 454-103
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APPENDIX VI
Individ"uAaclutBeoDdiycWteriyghTtsPoa(ggie) fc1Sr1otumdyayNwoirtthhPeRmOBSobwhite ET
Grmo ) Bi Dns Duis ChOawnlges Dum pCahalnigen CTohulm
183 Cow sm om as
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366
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600648
WILDLIFE INTERNATIONAL, LTO 56-
PROJECT NO; 454-103
APPENDIX VI Individual Body Weighs (g) from a Norther Bobwhite
`Acute Dietary Toxicity Study with POS. Page 12
TeeGroup.
Change
Change
Toul
(ppmai) Bid Day Dsyls Day8ls Day2 Dayisz Change
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09649
A ------------------------------------------
WILDLIFE INTERNATIONAL, LTD
5.
PROJECT NO.: 454-103
APPENDIVXI Individ`uAaclutBeodDiyetWaeriygThotxsic5i)tryoSmtudyNwoirtthhePrFnOBobwhite
Pag1e3
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60650
_--_--
WILDLIFE INTERNATIONAL, LTD oss
PROJECT NO 454-103
APPENDIX VII Feed ConsumptionD(ipebtiarryddTaoyn)icbiyyPSetnudryowmitahNPorFtOhSem Bobwhite Acute
Page 1
Teme Gn _--_-- Gpmai) Cont
--_--
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-_--
WILDLIFE INTERNATIONAL, LTD 59.
PROJECT NO: 454-103
APPENDIX VII
Fecd ConsumptionD(ige/tbairryd/Tdoaxyi)cbiytyPSetnufdyrowmitahNPoFrtOhSen Bobwhite Acute.
Experimental Group
Page Txporure Penna
ForExposure Period
_-- pmai)
Po TT Bwos TT Omer
183
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366
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-_--
WILDLIFE INTERNATIONAL, Lo
60-
PROJECT NO.: 454-103
APPENDIX VII Feed ConsumptionD(igebtiarrdyidTaoyx)icbiytyPSetnufdyrowmitahNPoFrOtSh.er Bobwhite Acute
Page
Tome Gro _-- (pmai) Control
--_--
Bere
Foren
Pa Due mm
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0
1
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SMDa.n T 22 ym :
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PRPROOIJEECCTTNNOO.::443541-01033
APPENDIX Vin CHANGES TO PROTOCOL
`1.waTshcelaprrifoiteodcol winadsicaamteentdhedco0lleicntdiiocnatoeflithvaetrbiflreowmiblilrbdesctohlaltedctiedddfurroimngslthsetucdoyurbsierodsf, thTehestpurdoytocol 2t.ubBesl.ooTdhseamprpolteoscowleriendcioclalteecdtethdaotnheDpaaryin8iaznedd Dvaacyut2i2nienrsnownouhledpabreinuiszeed.d mi borosilicate gloss est 3Br.eTfPlheMcet,pthe1r0te0so,t 1stwu8ab3so,sta3acmn6ce,eon7pdu3elr2dit,yto1cg4ih6va,enn2g9ie3n,tthh5ee86enseatwndccoe1rn1tc7if]eicnpattpermaoft.aifnroaloTnymessis0s,.co2n0c,en4t0r,at0i,o1n6s0w,er6e40chaanndge1d2800 4n.otTrheecotredmepedratures from several brooder units an Day 4,7, , and all brooder units on Day 22 were r5.esTthmeeanfttgermoouopnoonbsAeprrvait2i6o,ns1w9e99r.e inadvertently not recorded fo2 birds in the 640 ppm a.
"0654
_
WILDLIFE INTERNATIONAL, LTD
.e2-
APPENDIX IX PERSONNEL INVOLVED IN THE STUDY
PROJECT NO.: 454-103
"The following key Wildlife Intemational Lt. personnel were involved in the conduct or management ofthis study: (1) Mark Jaber, Wildife Toxicologist (2) Joann B. Beavers, Director, Avian Toxicology. (3) Sean P. Gallagher, Senior Biologist (4) Courtney Casey, MS, Seni Biologist (5) WillarBd. Nixon, Ph.D. Manager, Analytical Chemistry (6) Timothy Z. Kendall, Supervisor, Analytical Chernistey (7) Raymond L. VanHoven,Ph.D. Scientist (8) Ellen Mank, Chemist
G2O655
WILDLIFE INTERNATIONAL, LTD
ee APPENDIXX REVISED STUDY SUMMARY
PROJECT NO: 454-103
This study was reported using a test substance purity of 90.49%. The test substance Characterization was revised on 9/7/00, folowing study completion, and thepurity was determined to be 86.9%. The Sponsor requested that th results of thi study be revised to reflectthemost recent purity analyses. The results previously presented were simply corected by the ratioofthe two purities ora factorof0.9603. No attempt was made to recalculate analytical standard concentrations or measured concentrations from original raw data. As such, minor errors dueto roundingmaybe present. Attached i th revised summary pagefromth final report and the most recent certificate of analysis.
AMENDED
G5O656
WILDLIFE INTERNATIONAL, LTD
PROJECTNO: 454-103
"64-
REVISED STUDY SUMMARY BASED ON A PURITY OF 86.9%
SrovsoR. SPONSOR'S REPPRESENTATIVE:
LDOACTAATAINODN OAFCSOTUPDOYYF, RTHAEW FINAL REPORT:
IM Corporation Ms. Susan A. Beach
`EaWstioln,dMIaermyaltainodna2l16L0i1d.
ALTLD.BPIRSOJEICNTTNERUNMABTEIRO:NAL TEST SUBSTANCE: stupy: NCOONMCIENNATLRATTEISOTNS: TESTDATES
LENGTH OF TEST: TEST ORGANISM: SOURCEOFTEST ORGANISMS: AGEOFTEST ORGANISMS:
454103 PFOS (Perfluorooctane Sulfonic Acid Potassium Salt) PFOS: A Dietary LCS0 Study with the Northern Bobwhite 0,17.6,35.1,70.3, 141,281, 562 and 1125 ppmaii
`BEixopleorgiimceanltTaelrSmitna-atAirpor-ntilM2a2y, 1149,991999 Experimental Terminatio~n May 14, 1999 24
Norther Bobwhite (Colima Virginians) `EaWsitolnd,eMIanrtyelmaatnidon2a1l6L0i1d. Production Flock 10 days at est niiaion
Too 95% CONFIDENCE LIMITS: CONNOCMEONRTTRAALTIITOYN: CO'NNOC-EONBTSREARTVEIDO-NE:FFECT-
2zppmas 158 and 278 ppm a.
703 ppma
703 ppm ai
AMENDED
G59657
WILDLIFE INTERNATIONAL, LTO
"65
PROJECTNO: 454-103
CE ON e ante ee
Cl
INTERIM CERTIFOIFACNAALYTSIES
ConeAndRrLrsatTCr5H0OsR4MirEmee: 3184
oM A om-- o --T-- REv E---- --e . --
= yr
EB
gee |
iin
Ef rinn w
AMENDED
G006S8
WILDLIFE INTERNATIONAL, LTD
.
PROJECTNO.: 454-103
Ce NEr E ae TiF mera s
stmcomapenre Eon stn vrae--: i ire ieThEsTe
e TrT e CTA oAgE-------- ------ rnin mr Sm BoeEmp LEENTEEm, ELnmsE.mIEEt pan. ra---- ------ ------T ----A-- T--_
cn
rere
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WILDLIFE INTERNATIONAL, LTD
PROJECT NO.: 454-103
OuN rna cINE rRCnOaRcTe enIOLFe r CAVAALTsSTete po s e e5 s g- e t : .
EEE TCS av devin Ohwi dacs rp
vir -- Hh o-- m al _wEghspsldengh
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--_--_--mm----,--,----------
WWIILLDDLLIIFFEE IINNTTEERRNNAATTIIOONNAALL,, LD ~8-
PPRROOJJEECCTTNNOO:: 445544--110033
APPENDIX XI
Report Amendment
1 AOmreignidnaeldReRpeoprotr:t: TThielae Pagme ereponrtdadtewaesaddded.Thetotal umbofepagres
Reason:
wTaoiscnhdiacnagteedtfhraotmth r6e21p0o.6r9.twasamendedandnote changein
pagination.
2 AmOreignidnaeldRReepporotrt: TPhaegaem2endedreportdtc was added andthe exceptions 0the
Reason:
"cToomspliathncheeasomateenmwdeendt wreeproertredvaits,edprnoewvsigniaturdesaend
dsaattesmeonrtt.heamended report and tupdatethe compliance
3. AOrmgeinndaeldReRpeoprorti: PThaeges3uit desforth amended report wereadded.
Reason:
"sTiognsahtouwretahnedadmaetndfeodrrtehpeoarmeanuddeiddartepeosrta.ndto provaindeew
4 OArmgeinndaeldReRpeoprotr:t: Reason:
NPaegwessignatures and dates wer affixed anatdl change was mTaodper.ovidesignaturesand datesof appforr oth vameandled reportandtoupdamaanatgere's tle.
5. OArmgeinndaeldRReeppoorrt: PAapgpeendix X, Revised Study SummanadArppeynd,ix XI, Report
Reason:
"`TAomreenvdimseentth,e wTearbleeaodfdCeodnt0entthesT0abilnecloufCdeonthtenrtesv,ised summary
and report amendmen.
6 OArmgeinndaeldReRpeoprotr:i: Reason:
PAagfeootnoi and the amendedreportdatewere added to the STuomdmiaertytpahger. etaoAdppeendrix X, which contthaerievnisesd study summary and 0 show the amended report date.
7. AOrmgeinndaeldReRpeoporrti: Reson:
PAafgoeostnote was added tothe Test Substance txt "rTeocdenitecCerihfeircaetaedeorftoAnaAlpypseinsdix X, which contains the most
AMENDED
610661
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