Document 9JkVgMq1yM4GOqzBgKXoqv6ZR
AttacShtmuednitess taondLeOtttehrertoICn.foArumeartidoanteodn MCearyta1i8n, 2000 AR2%6 31 Perfluorooctane Sulfonate-Related Compounds
11.
y NEWFOSEMA
Neethyl perfluorooctane |suifonamido ethyl methacrylate
Acute Toxicity
1) AIacbuotreatOorrayl, RToixkiecriLtaybSocrarteoerniewsi,thIncT.,-3P4r9o4jeicntANlob.in0o88R4atAsR,0S0a1f3e,ty3EMvalRueafteiroennce No. T3494 (L-1048, FX-14), March 13, 1984
2) PlarbiomraartoyrSyk,iRnikIrerritLaatbioornaTteosrtiewsi,thInTc.-,3P4r9o4jeicntANlob.in0o88R4abEbBi0t0s1,2S,af3etMy REevfaelruaetnicoenNo. T3494 (L-1048, FX-14), February 7, 1984
3) lAacbuotreatOocruy,laRrikIerrritLaatbioornaTteosrtiewsi,thIncT.-,3P4r9o4jecint ANlob.in0o88R4aEbbBiOt0s1,1S,af3etMyREevfaelrueantcieonNo. T3494 (L-1048, FX-14), January 24, 1984
Immunotoxicity 1) 4G0u7i0n3e9a8P5i,g3MMaxiRmeifzearteinocne,NHoa.zTle-t3o6n10La(bNorBatNoor.ie6s36A0m1e-r3i2c,a,FXI-nc1.4,)P,roOjcetcotbNeor.9, 1984
Genotoxicity 1) ISnRIViItnrtoeMmaitciroonbailo,loPgriocjaelctMNuot.agLeSnCic-i3t1y45A,ss3aMysoReff3erMenCcoemNpoa.nTy-'3s6C1o0m(pNoBuNnod. T6-33661001,
32, FX-14), September, 1984
-
ane
005510
Experiment Hout Conducted At: pates conducted:
conducted BY:
Reviewed BY:
ues ons Torteiey seen
"ith 7-3494
{a Atbino Tats
{NweC n
Jen
"
oasanso013
ScaetentayuelEr,vaatlMuoianrtniiecosnsot:LaaBnOeT:StOrY
sanaary 19, 1984 to FRBEAEY 20 1998
DPeuxiiiconolnosRis,tmnsa5nnbboe5tr) Eface
Touay Director
oppSoarernazetonO eOdcroN,los5ie5O t H 3psledol e Soke. Toxicology
or wY5TTb..2 cmGMaroesaaceenoesmiieenx
005511
1.
summary
i
Lien 7-398 vas conducted 1%
he
acute oral 19, 1984 to
toxicity FEBRRTY
Seren 20 194
at
Riker
Laboratories: in BAY
32 st. Pauls eight from
January
sing
male
and
femal
aabino
rate
ranging BY
GEStEiC
intubation
at
J1i9n0n-e2s3o6tagrams. The testBa3X/XEIiCbIodaysweaidgmhitniwsittehrendo sorEaliEier noted during
+ dosage level of 5,000 ne 14 day observation periods
pierrhea vas nhootveedveoxn, dvaoyulednebeaneaxpseucbtseidded
by
the
day
four
cbaeTvaticn mia response, oil a8 tC enicte at a constant
volume
of
20
mL/kg. B03Y Necropsies
sing
cottonseed vere
noted
in
81
\ntsals
at
the
end no
of the SAY: Visible Lesions.
The
aight gains portorsed at
termination
of
he
study
revealed than
5:00
ng/kg
in
fasted
male
approximate oral 1050 of r-3asa is greater
ana female albino rats:
Introduction
of
this
SEY
WS
to
determine
the
acute
oral X05of the Food and,
the objectivealbino TES
mts
study
is
not
regulated of
1978,
although
Regulaticn
rp-r3o4g94Maiinnifsatsrtaedtion's God LaboratoorfynPirsactLiacbeoratory adnere Eh general
he
standard
operating
procediet me
raw
data
generated
bY
stay
pDriirneccitpolresanodf tthheisfizneagluTleaRtoirotn A1 stored in the conducting Laboratory's
archives.
005512
2.
ong method and
Results
anime
zats
vere
ued
17
restv,ithAoLnlaynisanailasslvserwehihcehldSwFetE
quaransine
fox
soeed 878 FE and settanIe
2
eooeing oot antsate
at
the
dnsetation
OF
2
Ton aay
tn goog weds
hesith The sata
vere
hued
7
J a permitced a standard
JOE
orane
aod
mast
controlled uring
a
16-20
hous
period
ssmeaieeel
J peter to uti treabation
food vas vissheld at a single dosae Jew
ne cate were administer6ed2e0 vS2a55nvevorltuanl of 20 S/H Tee 17
\11
doses
re
administered
the Tat saing
a
hypodermic
SYELRIS
equipped
With
&
he stomachs
iiecippea
of
intpeeios
needle
of
adstniasration
0
2%
settote,
tne
mats
vere Teed sen 8
eve susie thet cages and
cheered
9
2
ortong ape 1
14 gaye. Tits and adverse rescsions
(TLS
wna cima body eights, BOLE
animals that died during the
-
ty ao eh were recorded.
A
sn
"as conducted on
necropsy
Shon svinenatize?
=
tre
all
and
of
the
14
day
SPeSTEER
in the study:
period (Table 1)+ 208 `Theprotocols pErinHcipaalnpcerasnocnneels.taitnevmoelnvtedze contained 17
"posision ehassctasiscics
appendices I-IV.
2cuasten sive Bo avorasarLteesn, T0ne: WThIensSBEeeTnet1er WO 3BSrinmi Paamat, hnco.sew Be FR
005513
oe
--pose? lag/kg) so
5,000
TARGET
ACUTE ORAL TOXICITY SCREEN ALBINO RATS
sy:
ith T-3494 MEFS Jenctions
and
Body
Weight
DAES
sortality, Necrop BodyE weighE ts (9)T ymusbger mDea,d
animal
`pest
Day 7
Number1:a
umber Tested
Sex Number
MRA
22331a
228957
a3n3?9 288
o/s
4wrraat132 rare
22136
226683 285
330233
rats
236 207
251 226352
ors
F 4ARRae3332 rade
119901
221264 241
22585
44rRaa33s6
210959
23 251
pE ercS ent Dead o
test
article
Ws
aninistered
as
&
suspension in cottonseed oil: fasted pale and female
Fats:
2 Tne sme acute oral L050 is
Jeter
nan
5,000 ng/kg
in
Levealed no visible
lesions:
Nreocrlopesys performed upon termination of the SBAY three, inclusive:
advereseaRevaacsntiootnesd in all animate on days one thresh
005514
BESTCOPY AVAILARLF
-
meme appENDIX 1
-
PROTOCOL
rest.
Acute Oral Toxicity aM CRIS om sis
t. Paul,Minnesota
spoNsOR:
aluationLaboratory:Riker Laboratories, InC-+ S
CONDUCTED By: SafetyEv
--
TEST ARTICLE:
--
in E
Ht--
(CONTROLARTICLE:
PROPOSED STARTIN
GICOMPL
ETION
DATE
OF
TE
ST
:
uf
JSEOSUTRSCYES:TELM:HAFRrLeSwE eBweRrT,, o w a VETER, MPs.
Division
-
:
sNeuxm:beHr:F 5,5
Weight Range:
200-3%
grams
oe the tes
veof is tost wil ba to charac
1%acute.aE m E alavailabilty.
(OBJECTIVE:
Tr heobjectiresponse, historicE al Use. "ease In handling! `and gener
sh
cageisn
temperature
and gd
humid libitum
:
ducioifty of "The animal
s
will
be
hrionugsbeotdhitn hsetqauianlroealsnossrtticenoeedli`snaungds,tpaeecsnctdoerpdedirniwgoidr1es0.wmtiehtehe\faoeboodra?atonrydm'w'saatseetranodfafPredreR"do.pEeerlatdioneg sP
METHOD EcEaoancctrhhoalalnnenidmera,olowmisll`cdbueoorntkeigfireGdi0b1bye2caZdmiLniistnegr,edserachsema,Tfhowei ver, if this de osedt lev
Gasage of 2000 mo
E
Se S SimaE ls IntheformS receivede frdo`mbethhea.v`isopron
i
S e otocol. The e.testarticle willbreetuardnmeidn1i0sttehreeird
10 the cages
an and
observed
for
anyuntowar
nis pr after which
the
`animals
wil
be
r e E1E 8935 12, 5 theanimalrospssuyrvwiivlint
'
cB S ondtupcertieodd.oi nA"nsayp.logcartnioicsmsamaelbr nsnwtoihroimnaclh1i0tdi5iceesewYhiech aarnedcooobrnsdeturcevteoodbfbodsr1ueafrtivonergdi.tehsAe' cC`oAnrLcdhuicv`etG,a`toSafttghe`enPaenurlea,ctMeidnnbeYsohtea.
ttpodeisreectoriand the. final reportwillbe stored. in Stth.e LRoiukser,LaMissourt [a
ity
8Bprunne LabwoaratteoryGCFhow,RaTlsHt0on0HP3Eur1iDn0a,2 wor
ANH
ga {
DECE
3
Conon foo To
Vk J
1al=l% Doin mers - 1s
Date
"Study Director
"Sponsor.
0605515
5. ; Riker Experiment Noo ,_ossansooy = peviationas apnd/por1rA(pucenodnpacelnnutdsexd)2 rotocol 1. he weight range is extended E> 190-300 gn to expidite the Study:
w DSarundy UDirmece atobror 2 aat/e84
2
Seudy Director
Tate
3
Study Director
Tate
a
Sealy Director
ote
5
Seay Director
ee
005516
6.
-principal participatinAgPPpEeNrDsIoXnnIeTl Involved in the STUSY.
punction
name b. N. harkoe, Tres BS X. 1. Eobens, BS X. D. O'Malley, BS G. C. pecore
rSotxuidcyolpoigziescttor su`Tpoexrivciolsoogry Testing sceuntieorTTooxxiiccoolloodgyist snuipneravlisLoarboratory
005517
7.
APPENDIX IIT
Composition Characteristics
:
This study is not regulated by the Good Laboratory Practice Act of 1978 and therefore information pertaining to composition characteristics is not applicable for inclusion in this study.
005518
5.
APPENDIX IV guality Assurance Statement
regultateionstoufdy19i7s6,noatndoftfhiecrieaflolrye TeqstualtaetmeedntB.ystihgemeGdooadndLpabroerpaatroerdybPyratchteice
conpitance Audit department be standard operating
is not spplicable: procedures of this
laboratory
does
adhere
to
the
general
principles
of
this
regulation. The compliance Audit for studies underisy in
department the Acute
does
inspect different significant phases sociootogy Laboratory on & recurring
cycle,
and
the
factlities
oxo
examined
on
+"ttuhtrieoen maornethrosucthiendeullye.picIknedadadtitziaonndoan seXloemctthneumabrecrhiovfesReBsYeatrhcehc&omDpelviealnocpement
Audit department for review.
005519