Document oebZyoB01x5xgzdNkZjZwb3X3
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IM General Ottices 3M General Offices
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SSM rComer seston 3M Center
St. Paul, MN 55144-1000
FlgE _O0H 1A-R0R 232763_1038 612733 1110
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SSeepptteemmbbeerr 55,, 22000011
Document Processing Center (7407)
Document Processing Center (7407)
OOffffiiccee ooff TTooxxiicc SSuubbssttaanncceess
USS. Environmental Protection Agency U.S. Environmental Protection Agency
440011 MM SSttrreeeett,, SSWW.
Washington, DC 20460 Washington, DC 20460 Attn: TSCA Section 8(e) Coordinator Attn: TSCA Section 8(e) Coordinator
BEHO-20-37 2
600 Bl
Dl hd 2
DDeeaarr SSeeccttiioonn 88((e)) DDoocckkeett CCoooordrdininataotor:r:
Re: TSCA (6) Supplemental Notice on Sulfonate-based Fluorochemicals
Re: TSCA 8(e) Supplemental Notice on Sulfonate-based Fluorochemicals
W`Wiitthh tthhiiss lleetttteerr,, 33MM iiss pprroovviiddiinngg ffiinnaall rreeppoorrttss aanndd ootthheerr ssuupppplleemmeennttaall iinnffoorrmmaattiioonn rreellaatteedd ttoo pprreevviioouuss TTSSCCAA SSeeccttiioonn 8((ee))nnoottiiffiiccaattiioonnss.. MMaannyyoofftthhee eenncclloosseedd iitteemmss aarree aannaallyyttiiccaall rreeppoorrttss pprroovviiddiinngg bblloooodd sseerruumm aanndd lliivveerr lleevveellss ooff tteesstt mmaatteerriiaallss ffoorr wwhhiicchh tthhee iinn--lliffee rreeppoorrtt rwreehffeeerrrrreiintnghgettoo8(aacdd)mmnionintiiissfttieecrraeetdidodndoocssoeensssihhsaatssedaallorrefeaapddryyelbbieemeeinnnassruuybbdmmaititattt,eedwdettooattrhheees88u((bem))itddtooiccnkkgeetat.. fiIInnnaloottshhteeurrdyccaarsseeepssort.
where the 8(e) notification consisted of preliminary data, we are submitting a final study report.
Docket AR-226. We believe, however, ha placing these tems in the 8() docket may allow AAllll ooff tthhee eenncclloosseedd iitteemmss aarree aallrreeaaddyy iinn EEPPAA''ss ppoosssseessssiioonn aanndd aavvaaiillaabbllee iinn TTSSCCAA
Docket AR-226. We believe, however, that placing these items in the 8(e) docket may allow ffoorr mmoorree ccoonnvveenniieenntt aacccceessss ttoo iinnffoorrmmaattiioonn ddiirreeccttllyy rreellaatteedd ttoo pprreevviioouuss 88((ee)) nnoottiiffiiccaattiioonnss bbyy 33MM..
TThhee ttaabbllee bbeellooww ilissttss tthhee eenncclloosseedd iitteemmss aanndd rreeffeerreenncceess tthhee ssttuuddyy oorr ddaattaa wwhhiicchh aallrreeaaddyy hhaass bbeeeenn tthhee ssuubbjjeeccttoofaf ann 88((ee)) nnoottiiffiiccaattiioonn bbyy 33MM::
AAttttaacchteedd SSiubbamlivssiicona
Related Study/Data Already
Filed Under 8(c) Related Study/Data Already Filed Under 8(e)
1.
1.
lAAfmmoeennnaddmeeidddAAonynaa<llytythtiiaccanalloSSittnuuddTyyw,,o220(GN4en-EEetrthhaltypilpeoenrrlRfluautoorrRooeoopcrctouadnnueection,|| CCDoeovmmeblbioinnpeemddenOOtrraaalll a((GnGdaavrPaaeggreie)n)aFFtaeelrtrPiloiisty,i,natl
MsDDueSeitStfeeo6rrn,mmaiPminnFaiatdOtiioSoo)Ann-eAoot,hfftathanhneoedlPPiPrnreeFTssOeewnSnoccAeeGiaaennntddherCCaLootiinnovctneeernRntaartnatidtRiooePnnpFroOoofSfd,PPuFFcOtOiSoS.n,,|| DRREeIeeppFvrreOoolSdoduEpucmctitniieoonRnnatatTTlso,oaxxn3idicMciiPttyReyerSSifntueuardtdeayynl/cPooefofNsNNotn.--atTa-l
MCMMi3.55655C66,D,, BPPPFFEROOOVSSSAAAARAAA,P,,laPPunFFsdOORPSSaFAtAOsaaSEnnAxddpoiEEnsXtFetFhOdOeS0SLEEiE-.vOGeOrFHHOaniiSnndEtt-PhhOeFeHOSS,See3r,raMooff || s6E63u31t6Fb1.5Om6,i.S5JtE,euJdiunnnFeReeba33rt00su,,,a3r119M y999199R5,,,efu2fuel0lrl0err0neepcpoeortrN.t o. T-
|
CRCReRrefIfN:eeCUrreeD2nn0Bcc9eeR5NNV,ooA..JFuT"1n-/"P6e-3l6u131s611.6,R3.25,a0,t0sAA1nE.naxalylpytotisicceaadlltRRoeepEpotorFrtOt TTSOOEX-XO0-H1013,3.3,M
||
supplement aris fling submitted February 15, 2000
supplement earlier filing
to
LRN-U2095, June 11, 2001.
Cc
Ban
.
OoonnNtttaaaijiinn NNOO OcgB)I
~3 2S8R
=2 3388
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Exhibit
8
p-
!
aoosi22t77m88n99 0 | verowssss
MET 0438638
227788991.00000011
TTSSCCAA SSeeccttiioonn 88((e)) DDoocckkeett CCoooorrddiinnaattoorr
.
PPaaggee 22
AtasheloSemois Attached Submission
|| RReellaatteeFddilStetduutdUyny/dDDeaartaa30AAtlrreeasdtyy | Filed Under 8(e)
12. AAnnaalylyttiiccaall LLaabboorraattoorryy RReeppoorrtt,, DDeetteerrmmiinnaattiioonn oofftthhee
CCoommbbiinneedd OOrraall ((GGaavvaaggee)) FFeerrttiilliittyy,, |
1 DeveiandoeprpamabPeosnpa a| SPPPeeerrerrffsulleumunoocrraeoonoodaccnttLdaainnvCeeessoruanulofclfoef_onSnntpararatteateigo((unCCeAoA-fSSDaPNNwoulutmaembsysebireu:rmR:a22t7s755E99x--p33o99-s-3e3)d) iitnno tthhee || RDRineeepRpvrareotolsdod,upucAmctrtiiegoonunntsaTTlRooaexnxsidieccaiiPtrtyeycrhSSinttLauuatddbayoylor/PoaftofosPPrtFinFeOaOsSt,Sa.l ||
|
PSPFeRrOOuSSmvvaiinaadGGaLavivavagegere,o, fLLSaabpbororaragatutooerr-yyDaRRweepploeoryrtt NNoRo.a. tUUs22E00x00p66o,,sed to
| nc. Sponsor's Study No. 6295.9 fune | in Rats, Argus Research Laboratories, Inc., Sponsor's Study No. 6295.9, June
Reesor res No. STON 63959, eter 21,19. | 1: 159. ulrepo suomi Requestor Project No. 3M TOX 629~.9, October 27, 1999. 10, 1999, full report submitted
| Finan 15: 3000 pene February 15, 2000 supplementing 3. RReeppoorrtt AAmmeennddmmeenntt 1|,, CCoommbbiinneedd OOrraall ({GGaavvaaggee)) FFeerrttiilliittyy,, | eeaarrlliieerr ffiilliinngg
fons oA ao thi Developmental and PerinataUPostnatal Reproduction
Texiy Syof PROS Rats, Ars Reach Toxicity Study of PFOS in Rats, Argus Research
Laborer Ie Fron 1508, Sponsor's Sy No. Laboratories, Inc., Protocol 418-008, Sponsor's Study No.
3555. Ap 15, 3000 6295.9, April 13, 2000.
4 AvailRepor,DetermoiftnhParotseionnd |13-WeekDietary Study of Motil Analytical Report, Determination ofthe Presence and CCoonncceenntrtraattiioonn ooff PPeerrfflluuoorrooooccttaanneessuullffoonnaattee,, PPeerrfflluuoorrooooccttaanneessuullffoonnyyllaammiiddee,, MM555566,,aanndd MM557700 iinn tthhee Ever ndSer Samples Environmental Labosoy |63141, Cores Std No. 6329-335, Liver and Sera Samples, 3M Environmental Laboratory Ret No. 3536, TORO, Fea 35,3001 GTayted4u.n3e00500, 3000, Senton 3 ling Ref. No. U2636, TOX-028, February 23,2001
13-Week Dietary Study of N-Methyl
PPeerrfflluuoorrooooccttaanneessuullffoonnaammiiddoo EEtthhaannooll ((NN--MMeeFFOOSSEE)) iinn RRaattss,, 33MM RReeff.. NNoo.. TT--
6314.1, Covance Study No. 6329-225, dated June 30, 2000, Section 8(e) filing July 24, 2000
5 Amaya Laboratory Report, Determinatofiohen |FinalRepar Onl Govege) Analytical Laboratory Report, Determination ofthe CocFOSoFROn SA,PRi OSAAn andEFo OSE: | DevelToox,pSumdyoef0n5 Concentration ofPFOS, PFOSA, PFOSAA, and EtFOSEOe teSor and LiverofCRCDBR VATPls Ras | Biwlpaaroscaneuforamidon OH in the Sere and Liver of CrI:CDBR VAF/Plus Rats Brposcio NEFOSE, M Enirenmenal Lavoro | hon m Ra Melee No. T- Exposed to N-EtFOSE, 3M Environmental Laboratory Raper, TORO, Laborer Rosen No. L403 3. | 6316.7, December 17, 159, submited Report No. TOX-098, Laboratory Request No. U2402, 3M
NaF No T4316 Feary 6.3001 tp o SeoniSap docket or rer of | Ref. No. T-6316.7, February 6, 2001.
Final Report, Oral (Gavage) Developmental Toxicity Study of 2(NEthylperfluorooctanesulfonamido)ethanol in Rats, 3M Reference No. T6316.7, December 17, 1998, submitted to Section 8(e) docket per letter of
& Avatvical LabororyReporon heDrennan ofthe _| Fira Repr, Oral Somach Tae) Analytical Laboratory Report on the Determination ofthe En Deveopmeal Tous Say ors Presence and Concentration of Potassium Feoomsancautomme (PROSor sheemetbol of |EFOSE in Rabbis Reference No. Perfluorooctanesulfonate (PFOS) or another metabolite of Soappeuoroaesiomdihooyl (| T6316, Tamary 11 1999, brid 2(N-ethylperfluorooctanesulfonamido)-ethanol (NEIFOSE) m Liver andSerum Sprimens to Section 50) docket ur ie of EtFOSE) in Liver and Serum Specimens, 3M Enwionmena LabomoryRepos io TOX.91. periie Environmental Laboratory Report No. TOX-097, Eaborsory Ren io 2655 3M RefNo. T4316, Laboratory Request No. U2452, 3M Ref. No. T-6316.8, Fobra 8,201 February 8, 2001
7 Final Repo, Alsandr, B. Moraly rues of Workers| Freliminay aa sabi to Scion Final Report, Alexander, B., Mortality Studies of Workers Emalovesathe of Deas Fact, Univerosf | 56) docks in er of Dacor 15. Employed at the 3M Decatur Facility, University of Nimnsna. Ape 26, 001 ES Minnesota, April 26, 2001.
August 21, 2000
Final Report, Oral (Stomach Tube) Developmental Toxicity Study of NEtFOSE in Rabbits, 3M Reference No. T-6316.8, January 11, 1999, submitted to Section 8(e) docket per letter of August 21, 2000
Preliminary data submitted to Section 8(e) docket in letter of December 15, 2000
:
2
ver orssess MET 0438639
22778899..00000022
TTSSCCAA SSeeccttiioonn 88((e)) DDoocckkeett CCoooorrddiinnaattoorr PP,aaggee 33
T Avached Submi-sion [sont ReedsSttyDaas ready Attached Submission
Related Study/Data Already Filed Under 8(e)
+ Fr Report. Act Or Tox Srv wth T3ICAC| Acs Or Tory Semin 7. Final Report, Acute Oral Toxicity Screen with T-3290COC inane Rn Ss Evan Lavoro ie | eo py Sere wit in Albino Rats, Safety Evaluation Laboratory, Riker Cari, ne Fede OVARCHES SM Recess | Boman Lo Laboratories, Inc., Project No. 0882AR0362, 3M Reference
NNoo.. TT--33229900 ((4400 %% KI~'+PPFFOOSSAAAA iinn 33 %% EEttOOHH,, 1177% I% PIPAA
RAS L418 FOV Lot nemo | henSST RN and 40 % H20, L-6778, F-6873, Lot 501), November 5, Tov logo ery Doct Re kort | 00 0K BE Se 1982 [Bibliography entry in Docket AR-226, final report || a Dee S6r0i7i5nweLmcoeSIsroosnoinonlnosetrocskaaoviiss | was to be moved to TSCA 8(e) docket]
Acute Oral Toxicity Screen with T3290COC in Albino Rats, Safety Evaluation Laboratory, Riker
LLaabboorarattoorriieess,, IInncc..,, PPrroojjeecctt NNoo..
0882AR0362, 3M Reference No. T3290 (40 % K~PFOSAA in 3 % EtOH, 17 % IPA and 40 % H20, L-6778, F6873, Lot 501), November 5, 1982, submitted to Section 8(e) docket in August 21,2000 self-audit letter (which erroneously refers to rabbits rather than rats)
5 Gio, nd. Kannan Accumnionf rtm do ebm Soin | Giesy, J.P., and K. Kannan, Accumulation of Femmes od Raat aswel n | mane aT Perfluorooctanesulfonate and Related Fluorochemicals in Be Fish Tissue, Michigan State University, June 20, 2001.
Preliminary data submitted to Section 8(e) docket May 26, 1999
10. Gi, 17, sd K. Kann, Aumont 10. Giesy, J.P., and K. Kannan, Accumulation of Pemasamenlom ed em arachenicl a MPMieirnnfkkluaaonnrddooRRcitiavvenerresOOuttltfteoernrs,a,tMMeiaiccnhhdiiggRaaennlaSSttetaadtteeFUUlunniovirveoercrshsieittmyy,,icJJauulnnseein2200,, oo2001.
1 . ley, 12, and K Kaan, Petursctncifnnsd II. Giesy, J.P., and K. Kannan, Perfluorooctanesulfonate and Re Fite ya oer me. Related Fluorochemicals in Oyster, Crassostrea Virginica, Fm he Coffs apes poy Mn From the Gulf of Mexico and Chesapeake Bay, Michigan Se Uaveny 30. 30 State University, June 20, 2001.
1122.. GGiieessyy,, JJ..PP..aannddKK.. KKaannnnaann,, PPeerrffluluorooroocotcatnaensuelsfuonlfaotenaaanntdde RReellaatteedd FFlluuoorroocchheemmicicaallss iinn FFiisshh--EEaattiinngg WWaatteerr BBiirrddss,,
Michigan State University, June 20, 2001.
Pr -- 13. Giesy, J.P. and K. Kannan, Accumulation of
Perhuoraoeincsifonae nd Reled rarochemicas in| Perfluorooctanesulfonate and Related Fluorochemicals in
Vine ms i Se Cane acs | Marine Mammals, Michigan State University, June 20, Yar | 2001.
IIff yyoouu hhaavvee aannyy qquueessttiioonnss aabboouutt tthhiiss ssuubbmmisisssiioonn,, pplleeaassee connttaacctt mmee at (6511))773377--44779955..
SSiinncceerreellyy,,
.m
J Geol adamsLone Maannaaggeerr,, 33MM CCoorrppoorraattee PPrrooduucctt Reessppoonnsisbibililiittyy
EEnncclloossuurreess
.
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22778899..00000033
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MMEETT 00443388664400
i.
L774, F-aF73
,:
RsR 167
[RREECSEEWETD|
AAccuuttee OOrraall TTooxxiicciittyy SSccrreeeenn
vith m-3290000 with T-3290COC in atbine mats in ~tlbino Rats
{iHE wil Ln
Experipent No.:
~pe riment No.:
ossanoss2
0882AR036 2
Conducted at:
Conducted At:
RsFSSeiiaa.kkfteeeerrttRyyaLLuaaEP,bbvvooaarrmllaaiuuttnaaootntrrieiiiosoeenonsst,,aLLaabbIToonncerr..aattoorryy
St. Paul, Minnesota
DDaatteess CCoonndduucctteedd::
JJuullyy 3300,, 11998822 ttoo AAuugguusstt 2277,, 11998822
CCoonndduucctteeda BByy:
4ed@-Fo-373
H75H.1..5S5.L.abTRRohorouddaaoetssoorey smefnnoicinans iHcfes fithaiciiaditia Jr. Laboratory T~chnician
Acute Toxicology
D oT e Tarior,Conrandeo3n sweift
MDTS.ooerxaMdiy.scooMtlDaooirggrkiieosecettt,orJr., BS I Dat~
Study Director
RReevviieewweedd BByy::
ac mm. case M. T. C~se Xi. wens K. L. Ebbens
TE we FWW... CDC... MGMccrCCioofrrfmmiiitcchkk
fifi
00000088111188332218~
SKE.enSiD.or: a O'TMoamlielceo{ys,esiBasSet~ Sreentieor TToomxeioctoolnogyist
Acute Toxicology
Gy een l Date
Co:
.
ais
H
-
3
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--_-- even MET 0438641
22778899..00000044
1
Summary
Summary
An acute oral toxicity screen with -3290C5C wes conducted from
An acute oral toxicity screen with T-3290COC was conducted from
uJullyy
3300,,
11996822 ttoo AAuugguusstt 2277,,
1962 at Riker
1982 at Riker
Laboratories,
Laboratories,
Inc.,
Inc.,
St.
St.
Paul,
Paul,
Minnesota using pale and female albino rats ranging in body weight from
Mi.nnesota using male and female albino rats ranging in body w~ight from
209-269 grams. The test article was administered by gastric intubation at
209-269 grams. The test article was administered by gastric intubation at
a dose level equivalent to 200 mg/kg and 1250 ng/kg body weight with 0/10
a dose level equivalent to 200 mg/kg and 1 250 mg/kg body weight with 0/10
mortalities noted at the 200 mg/kg dose level and 5/10 mortalities noted at
mortalities noted at the 200 mg/kg dose level and 9/I 0 mortalities noted at
tthhee 11225500 mmgg//kkgg ddoossee lleevveell..
The untoward behavioral reactions which
T~e untoward behavioral reactions which
ooccccuurrrreedd
dduurriinngg
tthhee
2286
ddaayy
oobbsseerrvvaattiioonn
period
period
at
at
the
the
200 mg/kg
200 mg/kg
dose
dose
level
level
consisted of hypoactivity fram 60-120 minutes post dose adninistration.
consisted of hypoactivity from 60-120 minutes post dose administration.
he 1250 mg/kg dose level exhibited hypoactivity, ataxia, diarrhea and, in
The 1250 mg/kg dose level exhibited hypoactivity, ataxia, diarrhea and, in
the feaales, unkempt appearance. Recovery was generally precluded by
the females, unkempt appearance. Recovery was generally precluded by
Geath. Body weight gains were noted in all animals which survived the
death. Body w~ight gains w~re noted in all animals which survived the
study. decropsies perfomed at termination of the study revealed no
study. Necropsies performed at termination of the study revealed no
Visible lesions, however, autolysis precluded evaluation of three 1250
visible lesions, however, autolysis precluded evaluation of three 1250
magg//kkgs
ddoossee
lleevveell
aanniimmaallss
wwhhiicchh
ddiieedd
prior
prior
to
to
the
the
end
end
of
of
the
the
study.
study.
The
The
approximate oral LDSO of 1-3290CSC is greater than 200 mg/kg and less than
approximate oral LD50 of T-3290COC is greater than 200 mg/kg and less than
11225500
mngg//kkgg
iinn
ffaasstteedd
pale
male
and
and
female
female
albino
albino
rats.
rats.
IInnttrroodduuccttiioonn
he objective of this study was to approximate the acute oral LDSO of
The objective of this study was to approximate the acute oral LD50 of
7T--332299000C0OC iinn ffaasstteedd aallbbiinnoo rraattss..
This study was conducted for research and
This study was conducted for research and
development purposes and is, therefore, not regulated by the Food and Drug
development purposes and is, therefore, not regulated by the Food and Drug
aAdnmiinniissttrraattiioonn''ss
GGoooodd
Llaabboorraattoorryy
Practice
Practice
Regulation
Regulation
of
of
1978,
1978,
although
although
the
the
standard operating procedures of this laboratory adhere to the general
standard operating procedures of this laboratory adhere to the general
principles of this regulation. The raw data generated by the Study
principles of this regulation. The raw data generated by the Study
Director and the final report are stored in the conducting laboratory's
Director and the final report are stored in the conducting laboratory's
aarrcchhiivveess..
< 22778899..00000055
NET osa8s42
MET 0438642
2.2 o
veshon ana mesuits
Method and Results
YYoouunngg aal1bbiinnoo xraattss~ vweerree uusseedd iinn tthhiiss tteesstt.. AAlLl aanniimmaallss vweerree hheelldd uunnddeerr
quarantine for several daye prior to testing vith only animals whch appeased
quarantine for several days prior
to be in good heslth and suitable
to
as
testing with
test anisals
oantlythaeniimnailtsiawthiiocnh oafpptehaered
to be
study
in good health and suitable
used. The rats were housed
as
in
stuessptenadneidm,alswiraet-stehseh icnaigteisatiinon
of
the
study used.
camperature
a
The
nd
rats w~re housed
humidity controll
in
ed
rsouosmpsenadnedd,pewrimriet-tmeedsha
csatgaensdairnd
laboratory
temperature and humidity controlled rocks and permitted a standard laboratory
daiieettb pplluuss vwaatteerr aadd lliibbiittuums eexxcceepptt dduurriinngg tthhee 1166--2200 hhoouurr ppeerriioodd iimmmmeeddiiaatteellyy
pprriioorr
ttoo
ggaassttrriicc
iinnttuubbaattiioonn
wwhheenn
food
food
vas vitHheld.
was withheld.
he rats wre administered the test material at 200 83/kg and
The rats were administered the test materialc-- at 200 mg/kg and
1250 ng/kg body eight. ALL doses vere administered wndiloted dizectly into
I 250 mg/kg body
the stomchs of
weight.
the rats
uAslilngdoaseshypwoedreermaidcmisnyirsitnegreedcquunidpipleudtedWitdhiraectly
into
the stomachs of the rats using a hypodermic syringe equipped with a
bbaatlil--ttiippppeedd iinnttuubbaattiinngg nneeeeddllee~dd,.
Acer gustric sdsinistration of the est article, the rats were returned
After gastric administration of t~e test article, the rats w~re returned
to their cages and observed for the following 28 days. Initial, 14 day and final
to their cages and observed for the
body weights, mortalities (Table 1)
afnodlloawdivnegrse28 rdeaaycst.ionsIni(tTiaabll,e
114)
dvaeyrsand
final
body weights, mortalities
recorded. A necropsy vas
(Table I)
conducted
oanndalaldvaenrismealrseactthiatonsdie(dTadbluerinIg)
wtehere study
recorded. A necropsy was conducted on all animals that died during the study
a6 wll as those euthanatized and the end of the 26 day cbaervation period
as well as
(mble 1).
Tethose
euthanatized and the end of
protocol, principal personnel
the
in
v
28 day
olved
i
nobtsheervsattuidoyn,
period
(Table I ).
composition
The protocol, principal personnel involved in the study,
characteristics and guality Mesurance statement are contained
in
composition characteristics and Quality Assurance statement are contained in
sepenices - Tv.
Appendices I - IV.
2 king zave, oregon, a Taliton Purina Laboratory crow, Ralston purine, St. louis, Ho ~ King Labs, Oregon, WI
--Ralston Purina Laboratory Chow, Ralston Purina,
he `test arvicic i 40% s0Lids and was dosed at 200 mo/ks ana 1250 ma/kg of ~ The test article is 40% solids and was dosed at ssoolliiddss wwhhiicchh iiss eeqquuiivvaalleenntt ttoo aann uunnddiilluutteedd ddoossee "as is", respectively.
4 oper nd Somes ew ide asi, WY ~ popper and Sons, New Hyde Park, NY
St. Louis, MO
200 mg/kg and 1250 mg/kg of
ooff
550000
mmgg//kkgg
aanndd
3125
3125
mg/kg
mg/kg
66
_--
TT eronee
MET 0438643
22778899..00000066
3.
TTAABBLLEE 11
AACCUUTTEE
OORRAALL
TTOOXXIICCIITTYY
SSCCRREEEENN
- =
AALLBBIINNOO
RATS
RATS
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(DDsooass/eekg-a)- Sex ANAnuniimmmbaaellr
(m22g00/00k9) SeuMxw
N22uRmm33b5see8rr7 283588
2R222RRR3333555588989809
222R8R333555999110
220000 F 2228RR333666000877 22228R8R3333668600109980 2228RR333666111110
11225500 Mom 22a8R33m5599s32 22228RR3333555599995434 2228RR333555999566
11225s00 FFo 22mR33e6611z32 222R8R333666111443 222R8R333666111655
2R3616
ITnnddiiTvviieddsuutaallDayBSoeddNyyumbWWeeeri:gghht~ss
(3)
(g)
o0Test Day1144Number:2288
52255133 223990336 33352:188
222256661388 333302208689 333354661699
22666232 33301090 33346969
222221556 222666333 222666990 22221112996 222263433166 222255652027 222112982 222433515 222445979
222666055 (((Dvaaayyy 77))) 222266669033 (((DcDa3aayy0y3655))) 367 222666922 ((vD3aa0yy366)) 367
222112772 (aaDyyay 554)) 222211216624 (Ga(DDaaayyyy 4555)))) 222001994 (((DDaaayyy 353)))
SNuN,mu,bs-TebbreerrTeDDesetaaeddd
Number Tested
o0r/s5 oo//s5 a4s/s5 5/5
5/5
pPeerrDcceeeanndtt Dead 0
88O0
100
IO0
~ZhThee tteesstt solids,
Oaafrrttwiihccillceeh
wwtaahsse
aatddemmsiitnniiassrttteeirrceeldde
uucnnoddniislliuusttteesdd.~
ohfhooww4ee0vv%eerrs,,olittdhhsee.
ddoossee
rreepprreesseennttss
mgs
mgs
of
of
TT~eesoaalcciuudttsee,
ooorrfaallwhLLiDDc5Sh0O tiihsse ggtrreeesaattteearrrtttihhcaalnne 22c00o00nsnmiggs//tkksgg
oafnd40l%esssoltihdasn. 1250
and less than 1250
sg/ky
mg/kg
in
in
fasted
fasted
sale
male
aaNonntdde:ffeesmaaFllieegurrreaasttss..in parenthesis indicate time of death.
NNNNeoeocctcerEr:oeopppsesyiyFeisgupreersfoirnmepdaruepnotnhetseirsm
indicate
ination r
time of
ovealed
death.
no visi
ble
losions
at
the
200
Neevcerlo.psieTshepe1r2f5o0rmmegd/kgupodnosetcrlmeivnelatpiroondurccevdcaln~od vniosivbilseiblle~sioln~ssiounpsonatnectrh~ops2y0,0
m/ks dose =hgo/wekvgerd,ose
aaluuevtteoolll.yyssiissThpeprree1c2c5ll0uuddmeegdd/keegvvaadllouusaaettiioolnneveoolff
ptrhordeueceadnimnaolsv.isible
three animals.
lesions
upon
necropsy,
however,
7
22778899..00000077
TT
MMEETT 00443388664444.
Ye
2
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2-
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<89 |
2
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LEEg 3 |82 |-
sppi8d 2g.
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8
=
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35
ss
p3b8?
3
888 o
o o
3
5 8%
$e8g 3IT 813%
28 3%
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22778899..00000088
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TT WMEETT o0a4s3s8e6s4s5
Riker Experiment No.i__ 002;?3S33A~2O0I~8-336~22
aepErDIX 1 Riker Experiment No.:
5.
PAPRPOEThDOICXOIL
PROTOCOL
TrEeSsTt: AAecet,orera0rta!esTotxeictite)'y
SSPPOONNSSOORR:: 33MM_ CCoom~merrcciiaallCChheenm~iicc;a=lIss
CCOONNDDUUCCTTEEDD BBYY::
Safety Evaluation Laboratory, Riker Laboratories, Inc. St. Paul, Minnesota
Safety Evaluation Laboratory, Riker Laboratories, Inc., St. Paul, Minnesota
DiDviviissiioonn
TTEESSTTAARRTTIICCLLEE:: IT--3322900C0oCCC
conTROLARTIOLE:
Mew:
CONTROL ARTICLE: Lk ~<
PROPOSEDSTARTINGICOMPLETIONDATE OF Tes:
PROPOSED STARTING/COMPLETION DATE OF TEST:
fe =fefie
TesTSYSTEM: Pig RAT, 5 SRA
SOURCE: Kin Legs Clrecon, IN|
SNSeuexmx::be:14,r,:FF 45 WNeuimghbterR: an;g~e5:
200-709
srs
I ---------- Weight Range: 200-'-,00 gr~s
OBJECTIVE:
TThhee
oobbjjeeccttiivvee
ooff
hsthis
teesstt
wwiillllbbee
ttoo
characterize
characterize
the
the
acuta
acute
a=o--,.-:i
toxily of to test
toxicity of the test
OBJECTIVE: uct aarrtiiccllee iinn oaafllbbriiennsoopoT nse,a zhi-sattt osricals use. , ease _Finah~atandstsing_an_d_genwweeerrreea assveealleleaccbtteiedidy.aass aa tleesstt ssyysstteemm ffoorr rreepprroo--
MMEETTHHOODD:: doTTcCuohhmcneeiritberaaoillnnilatliaieyrmmddiaoalafrrlsso,oreoowwsmiwmlipllisslobbnddbeesuuoerrhhii,nsoonhgugueisssnbbeetoootddtrtehihciindnatthlhssebettuayasqqiienunuc,llaoaeerelrssaoaassnrnstesstciittnoneeidneeeeillnhaagssann,uunddssdapttpleiecenesscngnttoddrppaeedeenddrirdiniowowggiddiersrs1ee,n6, ewmwmtriheaiettehlshsahhl0fvoa0ccaoboada6ilraagg8a-beetisasaolirnntiiyynddn.'stwtweeaasmmtttpeepaerrneordrofaaafflfrteeuudrrrreeeeoddpaaaeannrddddatilhhiibuuntimmgtuiiumddpiir_b.tot-yy-.
SSoEcdaeooadadcscqiuaahurggeaeaeet,neiwooilmfhfcyaic"hclhhwawirIillialllcbcct*egooerrrmriitdezoaoeseJsnpkptgtooihfnneiwweddidlilltloobxbbttycheehteecyaaoaaddonlnofmmiirmimtinhancaliossl detnnetirnuuerssemgmtddb,baeeaeerrrcaassccoccoohh,nrndaaiaaancnndgicaidmmairatrtaodldol,,naathafhfhlfeoioxxwweaeleanddevbitvetmoeoorarrt,alt,hhtsoeeiiffrwyoiutth'luhstiitssssbsiiedtGdaeeoonassdoodaafmfaggittrheendhieslloecctepavveeeegralrleead.ddtAgiAoontehggsseessiinnpfgnngr.elooolseel-tt
aatSrrhrdsitseiecqalrpeucraoiaahttoteoelcSsyaouurlpcp.pThpTlalheehrmmm eatecetentenetsstratatilzlaaet ddrcttooihcsseeleaaggtwwoeeixilllillsceebbivvutseeyelrslasao.ed.dfmdmAAtihnnnieniyyissttaaetleeddsrrittdeeiidadtoirocntttniogocaalleettlhh,seddeaoo2aadssn0ndaai0iiggmtmieeoacalnlllasseaevlvriieneanleltsnsthhdimewweiiafiflllolsorbbmneowrirdyrdlleeooccbccieeeuuiivmmovaeeededdnnmntfftsireernoddoimsmbtaaettnnerhheddeaedffvssiiltpepheeodoedrnnswwstoeioirtsrhh,,t
`aawYacofictltneltoioidrimonunnweccssihilusffeiodocddrerhe.t,tohthnhbueeeutafftloloalnnllnaoooontiwtmwiiibbmnanaeegllgs'~slm3~i4:m~iiwlilhtadtei.~eadbey~hy~t1eo0,d;r;IIiennehthiiuteiediraaanaullerrradta,i,nnndtllgdoufuntinftihggnhnseasea,l,ilcrbilobiocvenodearddrg,yuy,ecwkwktsieioeddiainnggneehhdtyytthsssseobwwaatisennillselddtrbbvgageeeesedrrnneeweefeccrorlooaarlrlrlddaaegegnsdaday.s.stthutrAAreongoigtrianonrnotwoteiesssamssstratidilnnnnsaeaeblclcesrrutthororraaappvccvissttivyyoiwwrwnwaiighlllhlitirccbbehhheeo-
vcoctceooesponrctddteedpuodecrrrtiewwo.aiddinlt.hhdoAAnstsnnhppayyeeelclciagiainrrfiiaonocclssimssmm-aeoaaeplnsbbnotrnntwitoooohnrnrwmimictllehaoollbidittteihieeeeesssdtoowwourhrrhrggieiinacadcgnhnhintaaaahrrhneneededc/oooiobbRrnsisskdeseeiirurtrveevceetLOoddoabbfbscdsoeutuehrrrrrveiaivnenledgtgoed.is.tthsthAAe'ealllscAcroorrwacnnahwedwdiluulvcddecataa,tsttooaaStff.hggttehehePeenaaneunennlrireme,aaccttaMrereolioddsnppnsssbbeyuyyysrwwvottihithivlleealinbbsgseettuutrrhddeeeyy--
director and the final report will be stored in the Riker Laboratories' Archive, St. Paul, Minnesota.
2a_ pPuuyriinnaa LLaabboorraattoorryy CChhooww,, RRaallssttoonn PPuurriinnaa,, rBiEesEeFoao rweeidr FE Cw13e0rmnetlneh
St. Louis, Missouri FS2ot.rL0ouAis,anMI/kiksss-oo u(riaMs oSkoliPsE)RIsOoDlution
*dose at %wc:, le~-e!-~: 1230 r::9!]{~ ~ 200
iso Dusnf
iAeT: l LA
SpSopnonssoorr
2.2852 Dre cme bn ">
DGaattee- SSttuuddyy ODrireeccitoorr
Zkwo Date
22778899..00000099
MMEETT 00443388664466
: RRiikkeerr EExxppeerriimmeenntt NNoo..:: 00888822A0R800336622 6.
DeviationsAAPPPPaEEnNNdDD/IIoXXr AIIse((nccdoosnnecclnluutddseeddt))o Protocol
Deviations and/or Amendments to Protocol
1.
s sed solution with 40% solids not 508.
I. ~he test article was suDDlied as a solution with 40% solids not 50%.
-
-_ DSuaeynoiretcetearrban J
Study Director
v30T/atme2 Dat~
2.2e
_--
SSutugdyolDrireeecttsorr |mDaattee
w__
3m
-
---
Study Diereector
te
Study Director
Date
"
-
-
ee ----------
EE
Study pizeceoreeewate
Study Director
Date
s.
_
FN SStuuddyy Director EDaSt= Director
lo
; 22778899..00001100
TT wMeErTo0m4s38s6a4r7
7.
AAPPPPEENNDDIIXX IIIT pPrriinncciippaall Ppaarrttiicciippaattiinngg Ppeerrssoonnnneell IInnvvoollvveedd iinn tthhee SSttuuddyy
Name
Name
H. 5. Rhodes
H. S..Rhodes
DD.. HM.. MMaarrkkooee,, JJrr.., BBSS
XKK-.
LL..
EEbobbeennss,,
BS
BS
XK.. DD.. OO''Mkaalllleeyy,, BBSS
GG.. cC.. Ppeeccoorree
FFuunnccttiioonn JJArrc..uteLLaaTbboooxrraaittcooorrlyyogyTTeecchhnniicciiaann
Acute Toxicology
TTsootxxuiidcycoollDooiggriiessctttor
Study Director
STsuuoppxeeirrcvvoiilssooogrry Testing
Toxicology Testing
sSAeecnnuiitooerrToTTxooxixicicocololologogygiisstt
Acute Toxicology
sSAuunppieemrravvliissLooarrboratory
Animal Laboratory
n 22778899..00001111
-
-
EMETT 00443388664488
8.
AAPPPPEENNDDIIXX IT CCoommppoossiittiioonn CChhaarraacctteerriissttiiccss
TThhiiss
ssttuuddyy
iiss
nnoott
rreegguullaatteedd
bbyy
the
t_he
Good
Good
Laboratory
Laboratory
Practice
Practice
Act
Act
of
of
1978
1978
aanndd
tthheerreeffoorree
iinnffoorrmmaattiioonn
ppeerrttaaiinniinngg
to
to
composition
composition
characteristics
characteristics
is
is
not
not
aapppplliiccaabbllee
ffoorr
iinncclluussiioonn
in
in
this
this
study.
study.
1 22778899..00001122
TT
vMEeT T04o38m64m9 a
s.
AApPpPEENNDDIIXX ITVV Quality Assurance Statement
Quality Assurance Statement
TThhiiss
ssttuuddyy
iiss
nnoott
ooffffiicciiaallllyy
rreegguullaatteedd
bbyy
the
the
Good
Good
Laboratory
Laboratory
Practice
Practice
RReegguullaattiioonn
ooff
11997788,,
aanndd
tthheerreeffoorree
aa
ssttaatteemmeenntt
signed
signed
and
and
prepared
prepared
by
by
the
the
CCoommpplliiaannccee
AAuuddiitt
ddeeppaarrttmmeenntt
is
is
not
not
applicable.
applicable.
TThhee
ssttaannddaarrdd
ooppeerraattiinngg
pprroocceedduurreess
of
of
this
this
laboratory
laboratory_
does
does
adhere
adhere
to
to
the
the
ggeenneezraall pprriinncciipplleess ooff tthhiiss rreegguullaattiioonn..
The Compliance Audit dnpartment does
The Compliance Audit department does
iinnssppeecctt
ddiiffffeerreenntt
ssiiggnniiffiiccaanntt
pphhaasseess
ffoorr
ssttuuddiieess
uunnddeerrwvaayy
in
in
the
the
Acute
Acute
TTooxxiiccoollooggyy
LLaabboorraattoorryy
oonn
aa
rreeccuurrrriinngg
ccyyccllee,,
aanndd
tthhee
facilities
facilities
are
are
examined
examined
on
on
aa tthhrreeee mmoonntthh sscchheedduullee..
IInn
aaddddiittiioonn
aa
sseelleecctt
nnuummbbeerr
ooff
RReesseeaarrcchh
&
&
Development
Development
ssttuuddiieess
aarree
rroouuttiinneellyy
ppiicckkeedd
aatt
rraannddoomm
ffrroomm
tthhee
Archives
Archives
by
by
the
the
Compliance
Compliance
AAuuddiitt
ddeeppaarrttrmeenntt
for
for
review.
review.
13
-
TT
--
22778899..00001133
TT wMEeTT0o4s38E65e0s0