Document 2qXy3G7jd4YZxxbb5K4mVaQgb
Attachments to Letter to C. Auer dated May 18, 2000 AR226-0242
PerSftluudoireosoacntadnOetShuelrfoInnaftoer-mRaetliaotnedonCoCmeprtoauinnds
[7 nNm-eMerFoOsSaA|| N-methyl perfluorooctanesulfonamide
Acute Toxicity
1)
Acute Oral Toxicity ~ Laboratories America,
MIenct.h,oPdr,ojSeuctmmNaor.y5,05P0a3t4ho9l9o,gy3MQAReUfeRreepnocret,NoH.azTl-e3t7on52
(F-
7075-4, water-washed, acid washed), July 12, 1985, with Protocol
2) PLarbiomraartyorDieersmAamlerIrirciata,tiIonnc.~, MPreotjheocdt,NoS.um5m0a5r03y5,0P0a,t3hoMloRgeyfeQrAenUceReNpoo.rtT,-3Ha7z5l2e(tFo-n 7075-4, water-washed, acid washed), June 24, 1985, with Protocol
3) PLarbiomraartyorEiyees IArmreirtiactai,o--nInMc.e,thProodj,ecStuNmom.ar5y0,50P3a5t0h1o,lo3gMy QReAfUereRnecpeorNto,.HaTz-l3e7t5o2n (F7075-4, water-washed, acid washed), June 24, 1985, with Protocol
4)
Acute Oral Toxicity Method, Summary;
-- Method, Summary, Primary Eye Iitation
Pathology; -- Method,
Primary Dermal Summary; QAU
Irritation -- Report; Raw
DReaftearAepnpceenNdoi.x,T-H3a7zl2e7t(oFn-L1a0b0o3r4a,toLroites7,Admiesrtiilclae,d wIincd,e.-rParnogjeec)t, NMoa.y507,201294875,3,wi3tMh
Protocol
5) Acute Oral Toxicity Screen with T-3065CoC in Albino Rats, Riker Laboratories, Inc., Experiment No. 0981AR0145, May 15, 1981
Genotoxicity
1) INno.ViLtSrCo-M3i1c4r5ob,io3lMogRiecfaelrMeuntcaegNeon.icTi-t3y7A5s2sa(yFs-o70f75T--43,75w2a,teSrR-IwaIsnhteedm,ataicoindalw,asPhreojde)c,t June, 1985
2) NIno.ViLtSroC-M3i1c4r5ob,i3olMogRiecfaelrMeuntcaegNeoni.cTi-t3y7A2s7sa(yFs-o1f0T0-343,72Lo7t,7S,RdIisItinltleemdawtiiodnea-lr,anPgreo)j,ect March, 1985
12-
-
01010
HAZLETON verore worcne SlamGAAS SOE An
or KIOWABLVD-.70. BOXTE+AMADSISON,WISCONSINS707 + PHONE(608 24-4471 + TIXT0398RAZRAL NDS UD
FINAL REPORT JHTAOINXNIINNCEEOSLOOTGGALYEAMSISNOEINRNVGICE&SMANUFACTURING COMPANY ST. PALL, MN 55101
EERE
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4UEEIA
RSI Sa NUMBER:
SAMPLE ENTERED:
REPORT PRINTED:
50503499
05/15/85 07/12/85
T3752 PURCHASE ORDER NUMBER: T357842, REL. $513
ENCLOSED: AACUUTEREPOORRATL TOXICITY - METHOD, SUMMARY, PATHOLOGY RAW DATA APPENDIX
SIGNED:
SSTTEUVDEYNeDMIm.ReEGCLTAOZRN A W ACUTE TOXICOLOGY
BLATLEL DERS
BY AND FOR HAZLETON LABORATORIES AMERICA, INC. AAlMsERIDCAAT,A FIONRC.,THMIASDISSTOUND,Y WAIRSECOKNESPITN.ON FILE AT HAZLETON LABORATORIES
601011
@ HAZLETON verre womens Gpanion iti Sines Hrson
sonpLE numer: 50503499
Pil
ro3752
seco oral screen
gBfeectrteiraviea:liToeondaseatmEienrieamtiennr(eed0C0boyotHreole gCoealraat3ItTeaknsAi"EsEe0nsaErasicnetgntie1d0inthaeey 12c,or1981.
TesE2tryTasEtieTcreIilaEtT Dsescr1i-E pt3i7o5n: Surenmm g9rroinnuailaar0sc0liSd 1g ana stability
LoooSotnuldesmhiunnaSilt:rainvtuowmuecnarnsteroalodlruelodtcusrmueordl,sermes,ndnfemcaBrulleee dslbCiDonoent raarteschaao.rfaostaeheesosfSpatrteaguluereaisnte
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Eater hea Ll SR. tthhe eeniamnalneclIaEssiCciaklslytouusneddodtuss:
to
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CIcaapSlieztiiaeTteoddreotonnrycTaceahmtpienranapistleuerbteeutpreinetLmoilSo009B,hiRoeEhaIodY beLeoissnsenaosalendaanessemin esSoorEgnetEiosns:.ne htoTheeaalmairnnieasnalTeiaetvroenreetcebsebaserrveudtedfofmoenrtedcrlsinSTiicInahl SsiglnSs naentd mo"orTeteanlsity
Pathology:
:
At study termination surviving animals were euthanatized.
>
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Shel Sori----acon: Oro Gavase bate Test Started: 15/30/85 bate Test Completed
06/20/85
eetientns Gran 10308 HTaatele- SBeteumeenn0.200 and12.0 g/kAg of bodEyasiLghte
orto ity Summary Gunber of Deaths)
PpCaageRp T1 Mews LLRe dS ebosweI e wLee aBe n TFewo
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sonmLE a: 51503499
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reso
acco ora scree
cconrinues Clinical signs
opasn 12s as Fonee s won uno
Dosage Level - 0.20 g/kg
pfBpoeemaeesnirsneesrneoerlest 64Tos33 22
onr2niaIHE otseessEZ estsE Ezes 3 o0sS0I sos3s E 5e soosd
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0 0 0 5--======
HAZLETON vememmencars
vomit ion since sin
SaPLE nuERs 50503459 37m oECo oReL screen
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Dosage Level - 5.00 g/kg
aSGpopreeranrreesdtn,ormal 5s0 o443 i90
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Hates tt0teee0 lcI- lzI-cI=IIIIIIoIcIIcIIzIIooz=looz=I Iooo=IIIlo=Ils= ifieccmIImcazsIzIIsoo nzonozsiols
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01015
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Gosage Levels 0.20 s/h of boss TJED ae olrezEeiOoyns oo no w awe ov - e gwen. wen woe cw on - ae mw r cass Fou case F case F wwf - wm
es
eevee umiont Gate Cosed: 06/04/83
eoroney Comments No visinie issione: to wistate morn. to wrasoin estore. ro wasn etores No viiste instore: to wistste tomes to reson Tostone: to wratein rentoner to tater rovinres Liver < bagasse anomaly a em oT
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SrPLE NuBER: 50503459 --
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(conTiNuED)
PATHOLOGY. (contined)
Dosage Level: 2.00 g/kg af body weight Date Dosedi 06/04/85
nfmiemall er DienTesbteeDvaiyicsd Necropsy Comments
cases m1 =
[RedSpTarRinasE al dN ischarge; dH ark red,
Solio
wm 4 1 =
TBRedeepartinnaaastseleTdedihaseecachrairlgsnea;tlmoapoteserriinaelu.m -
cam m1 =
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dark red, al Senn
carr m1 =
Rheodtpterionlaisvaolrtidiirsrcshnargfei; lpeorineun -
cz m2 -
ReTediepelrnieneeaSlionadmiasrcgrheiaso.rtg;ejseubmpilemar.tienreaaunldm -
a ee ae nis atara
cass Fo 1 =
Parinaun stained yellows small
cases Fo 1 =
Par ineun stained yellow; small
cams PF 1 = csr FP 1 =
cus Fo 1 =
perineum = stained yellows jojunum Perinoun - stained yellows small et eerie Perineun - stained yollous small
601017
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ates was sone PATHOLOGY Coantinusd) connie
bosage Levels 3.00 gre of body weight Date Doseds 15/29/95
fTiEveN cer oieTesBteDiacy ed vecrapoy Comments
ows m3 - S Grogaa ct = awaptg atg dark brown
Ges ow 2 -
No visile lesions.
Ges on 2 - SSttoantaoanch ccoontpaienss dark broun
Ges on 2 - I
Fa
sew m2 - MO
Gan rz - No visible lesions.
cass Fz - fi wiesitte onions
came Fz - uppar thorsiie cavity somtaine
cass Fz - No visible lesions.
C34467
F
2
-
No visible lesions.
fSoreemlees: rguniTasteion for Exams Comer ionandOn
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BEST COPYAAaVAnL AALDLE
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@ HAZLETON Uisoraronies AvERICA. ie SNOTOHABLVDN. + 3. 80K TS + WADON WITT + Fo+ or x TATE Ho0n0
eromocor. Tr2069
EEE,
Acute Oral Toxicity Study in Rats (OECD Guidelines)
Seudy No. 30503499
{|
MMaAvTosIiAsNeEs
b
ANe 3% /
tor st. Paut,ainnesota .
by
Sarleton Liboestorien favrice, 95. Ma3Ld3ii0fs1eonKS,icniWseimnsaccneosnBsoDiuiniveivs3ai5ro7dn04
vay 21, 1985
1985, Hazleton Laboratories America, Inc.
Chemical & BioMedical Sciences Division
01053
PROTOCOL TP2069 Acute Ora(lOETCoDxiGcuiitdyelSitnuedsy) in Rats
Study Nou: Study Location:
Test Material: Sponsor's Representative: Study Director: ProposSetdarTtiimnegtaDabtlee:
CFoimnpalletRieopnorDtatDea:te:
50503499
HLiafzeleStcoinenLcaebsoraDtiovriiseisonAmerica, Inc. 3M3a0d1isoKni,nsWmainscoBnosulienvar5d3704
3752
Janine Gleason
Steven M. Glaza
.
Week Week
of of
May June
271,7,
19189585
Week of July 15, 1985
01054
onsecTIvEs To determine the acute oral toxicity produced hen the test material is administered by the oral route (gavage) to rats. ALL aspects of this study Vill confora to the Organisation for Economic Cooperation and Development's Guidelines for Testing of Chemicals, Section 401, adopted May 12, 1981" and
Principles of Good Laboratory Practice.' ALL procedures will be done
according to Hazleton Laboratories America, Inc. (HLA) Standard Operating Procedures (50Ps) referenced in this protocol.
Test Material: Physical Description: Purity aad Stability: Storage Conditions: Test Material Retention:
Sifety Precautions:
TEST MATERIAL
T3752.
.
Bron granular solid.
dSpeotnesroarinhaatsionpsuriotny fainlde. stability
Store at roca temperature.
cAentyurumneudsedto ttehset Smpaotnersioarl30widlalysbeafter Sssuance of the final report.
Lnaobromraaltonreycepsesrasroynnpreelcawuitlilontsakien the hStalonoxdvielcsii,tnyg.sa&fesLtuaybbsotgrlaaantscosereyso,fcloautnnhdkinno4gw,npaclcaitcelxe vBouraak.approved for toxic dusts aust be
01055
2
TEST SYSTEM
Inizal Hodel
Young adult male and female albino rats (approximately 7 weeks of age) of the Sprague-Dawley strain will be obtained Fron Harlan Sprague-Davley, Madison, Wisconsin. Rats vill be selected at random from healthy animals that had been acclimated at HLA for at least 1 week. An adequate number of extras will be purchased in order that no animal in obviously poor health is placed on test. The weight variation in animals used on test will not exceed +20% of the mean weight (i.e., mean = 250 g, rage = 200 to 300 g).
Reason for Species Selection The rat is the animal classically used due to its small size, ready
availability, and large amount of background data.
Identification Each animal will be assigned an individual animal number and ear tag which
will accompany data collected from that animal throughout the study (oP-GENB 24.)
Housing and Maintenance The following environmental conditions will be maintained in the anizal
room used for this study (OP-TARC 230). oo RTeelmapteirvaeturheu:midi2t2y:C 3250% +202 o ALiigrhtchcayncglee:: At12 lheoausrts 1l0igchhta/n1g2eshoaunrshoduarrkof filtered 100% outside air
Temperature and humidity vill be monitored throughout the study. Variations from prescribed environmental conditions will be documented.
019056
3
minal husbandry and housing at HLA couply with standards ouclined in the
"Guide for the Care and Use of Laboratory minals."' Care will be taken to
ensure chat the animals are not disturbed for ressons other than daca collection and routine maintensnce. The aninals will be individually housed fa acceembotton stainless steel cages held on racks, with absorbent pan Liners ia the urine- nd feces--collecting pans. Pan liners will be changed at Least three cines each week.
Feed and water will beprovided ad libitum. The diet will be Purina Rat
Chow*., No contaminants are expected to be present in the feed or water
"hich would interfere and affect che results of the study.
Experimental pesign
BRocEDRES
Initially, a single dose of 5.0 g/kg will be administered to 10 animals
*
(five males and five females). If no test material-related mortality is
produced at this Level, no further testing is required. If any aorcality
occurs at the 5.0-g/kg dose level, at the Sponsor's request, three or four
geomstrically spaced dose levels may be added. Bach dose Level will consist
of 10 animals (five males and five females). Animals will be assigned to
sroups according to LA Standard Operating Procedure OP-TOX 42.
Test Material Preparation snd Administration
The test material will be suspended in an appropriate vehicle. Individual
dosages will be calculated based upon che animal's body weight taken just before aduinistzacion of the test material and aduinistered by gavage.
01057
4
Justification of Route of Administration
This is the method for administering a known quantity of test substance and has been the route of choice historically.
Observations The animals will be observed individually for clinical signs and mortality
at 1.0, 2.5, and 4 hours after test material administration. The animals will be observed daily thereafter for ac least 14 days for clinical signs and twice daily (morning and afternoon) for mortality. The duration of observations may be extended when considered necessary. The time of death will be recorded as precisely as possible.
Individual body weights vill be recorded just prior to study initiation and at 7 and 14 days following test material administration and at death. Changes in body weight vill be calculated and recorded when survival exceeds 1 day.
Pathology
:
ALL test animals, whether dying during the study or sacrificed at
termination, vill be subjected to a gross necropsy examination and
abnormalities recorded.
Report
The final report will contain a description of the test material, a description of how the study was conducted, response data for clinical signs, mortality and body veights by sex, a discussion of the data, and gross pathology findings.
01058
5
Maintenance of Raw Data and Records
Original data or copies thereof will be available at HLA to facilitate
auditing the study during its progress and prior to acceptance of the final
Teport. When the final report is completed, all original paper data, as well
as the final report, will be retained in the archives of HLA, Madison,
Wisconsin (OP-GEN 44).
:
REFERENCES
1.
OTregsatniinsgatoifonGhefomricEaclosn,omSiecctCiooonp4e0r1a,tioAncutaned ODreavlelToopxmiecnitt'ys,
Guidelines for adopted tay 21,
2. Organisation for Economic Cooperation and Development's Principles for Good Laboratory Practive, Awnex 2, 1981.
3. DHEW Publications No. (NIK) 78-23 (1978).
01059
.
6
PROTOCOL APPROVAL
re WCine esson * nsor's Representative Studm y DWi.ree Gcltaozre We HGarzolueptoLneadLearb,oraAtcourtieesToAxmiecroilcoag,y Inc.
(11078/tji)
Bite5 [a4[R5" Bite | S-228S
C01060
