Document wr109ZOkwMdo438mMXqeMkm6B
.
10500 157
Attachments to Letter to C. Auer dated May 18, 2000 ( 85000000010 )
Studies and Other Information on Certain
I
Perfluorooctane Sulfonate-Related Compounds
Cond't
8. N-EtFOSE alcohol | N-ethyl perfluorooctane sulfonamidoethanol
Acute Toxicity
1) Corrected Final Report, Acute Inhalation Toxicity Study in Rats, 3M Reference No.
T-29911T, Hazelton Laboratories America, Inc., Study No. 154-157, February 2, 1981
Genotoxicity
1) Final Report, Mutagenicity Test on T-5710 in an Jn ivo Rat Micronucleus Assay,
Hazelton Washington, Inc., Study No. 15516-0-454, April 23, 1993
2) Final Report, Genotoxicity Test on T-5710.1 in the In Vivo/In Vitro Unscheduled
DNA Synthesis and Cell Proliferation in Rat Liver Cells, Hazelton Washington, Inc., Study No. 15516-0-494, September 14, 1993 3) Final Report, Mutagenicity Test on T-6292 in an In Vivo Mouse Micronucleus Assay,
PHraozteolctoolnaWmaesnhdimngetnotns, Inc., Study No. 17384-0-455, May 2, 1996, with Protocol and 3M Reference No. FM-3923 4) Evaluation of the Mutagenic Activity of T-6906 in an In Vitro Mammalian Cell Gene
Mutation Test with L5178Y Mouse Lymphoma Cells, NOTOX Study No. 223458,
a) Final Report, December 22, 1998 (see letter below) b) Letter from Steve R. Haworth, Ph.D., Covance Laboratories, reviewing the
NOTOX study and concluding it was technically inadequate and should be repeated
Note: 3M is repeating the study
Repeated-Dose Toxicity 1) Final Report, Ninety Day Subacute Rat Toxicity Study on FM-3422, Intemational
Research and Development Corporation, Study No. 137-086, November 10, 1978
-13-
001247
Attachments to Letter to C. Auer dated May 18, 2000 Studies and Other Information on Certain
Perfluorooctane Sulfonate-Related Compounds
2) Final Report, Ninety Day Subacute Rhesus Monkey Toxicity Study, on FM-3422, Intemational Research and Development Corporation, Study No. 137-088, January 16,1979
3) Two-Year Dietary Study a) Report, Volumes 1-5, Two Year Oral (Diet) Tox/iCarcciniogetnicyity Study of Fluorochemical FM-3924 in Rats, Riker Laboratories, Inc., Study No, 0281CRO012, August 29, 1987, Conducted during April 1981 - May 1983 b) Report Amendment No. 1, Two Year Oral (Diet) Toxicity/ Carcinogenicity Study of Fluorochemical FM-3924 in Rats, Riker Laboratories, Inc., Study No. 0281CRO012, October 25, 1988 ) Xenos Letter dated May 24, 1991 with attachment: 3M Response to FDA Letter ofDecember 10, 1990 {re 2 year cancer study), Food Additive Petition Nos. 0B4197 and 0B4206 d) Pathology Review of Reported Tumorigenesis in a Two Year Study of FM-3924. in Rats, Pathology Associates Intemational, November 25, 1998 ) Analytical on retained sample f) Review by Dr. William H. Butler of Two Year (Diet) Toxicit/y Carcinogenicity Studyof Fluorochemical FM 3924 in Rats
4) Ongoing 2-Year Study &) Summary Report of Week 53, 104-Week Dietary Carcinogenicity Study with 3NaMrrRoewfeRraenncgeeN(o9.8.T1-%6)31N6-.E1t,hyClovPaenrcfleuLoarbooorcattaonreisesu,lf6a3n2o9a-m2id1o2 Eatnhdan2o2l8in(Rdraatfst, final report expected fall 2000)
Pharmacokinetic Studies
1)
Synthesis
1981
and
Characterization
of
N-Ethyl
FOSE
'C,
Riker
Laboratories,
March
17,
2) Final Report, Absorption and Biotransformation of N-Ethyl FOSE and Tissue Distribution and Elimination of Carbon-14 after AdministrationofN-Ethyl FOSE -
VC in Feed, Riker Laboratories, Inc., January 19, 1983
"le
001248
Attachments to Letter to C. Auer dated May 18, 2000 Studies and Other Information on Certain
Perfluorooctane Sulfonate-Related Compounds
MPeretvaibooulsilsymsoufbmTi-t6t2ed92wi(tnh-cMthayyl F4,OS2E0)0,0Tle-t6t2er9-3 (Qnu-acltihtyaltiFvOeSIEnvepshtoisgpahtaiotneodfitahemmIonnViiutrmo salt(ester)), T-6294 (n-cthyl perfluorooctane sulfonamide) and T-6295 (perflurooctane sAudlvfaonnacteed) bBiyoRanaatlyatnidcaHluSmearvnicHeesp,aItnocc.y,t[ePsreUlsiimningarfyo]n ASnparlayytiLcCal/MReSpoarntd, LReCp/oMrSt/MS, 96ADEMO1.3M, November 12, 1996
Previously Analytical
submitted with May 4, 2000 lette-r Report, Additional Characterization
Advanced Bioanalytical Services, ofMetabolites of T-6292, T-6293
Inc., and T-
S6e2m9i4-QfuraonmtiRtaattiavnedAHnualmyasnisHoefpaTt-o6c2y9t5esinbyRaTtuarnbdolHounmSparnayHeLpCa/toMcSytaensdILncCu/bMaSte/dMwSi.th T-
6292, T-6293 and T-6294 by LC/MS/MS, January 28, 1998, Report 98AGKPO1.3M
Mechanistic 1) FHianzaelltRoenpoWrats,hAinnagltyosni,soInfc.T-S5t8u7d7yiNnoa.C1el5l4-P2r0o8l,if3erMatRioenfeArsesnacye iTn-5Ra8t77Li(vweirdeCerllasn,ge
PetrhoytlocFoOlSAEd)d,eFnMd-u3m9,24K,eyLotto 5F4C7,AlLc-o1h3o2l02T,oNxoSvaemmpbleers (1,in1c9l9u4d,inwgit5h87P7r)o,toacnodl and Analytical data
Teratology
1) Oral (Gavage) Developmental Toxicity StudyofN-EtFOSE in Rats
a)
Final Report, Oral 3M Reference No.
(Gavage) Developmental T-6316.7, December 17,
Toxicity 1998
Studyof
N-EtFOSE
in
Rats,
b)
Summary N-Etfose Rat Teratology, Oral Of N-EtFOSE in Rats, 3M Reference No.
(Gavage) T-6316.7
Developmental
Toxicity
Study
2) Oral (Stomach Tube) Developmental Toxicity Study ofN-E{FOSE in Rabbits
a) FininRaalbbRietpso,rt3,MOrRaelf(eSretnocmeacNho.TuTb-e6)31D6e.v8e,lJoapnmueanrtyal11,To1x9ic9i9ty Study of N-E(FOSE.
b) STouxmimciatryySN-Et(oFfu ONS-EEd{RaFbOy bSiEt TienraRtaoblboigtys,, 3OrMalR(efSetroemnaccehNTou.beT)-6D3e1v6e.l8opmental
3) Teratology Studies of T-2999 (FM-3924) in Rabbits
. S1s- 601249
Attachments to Letter to C. Auer dated May 18, 2000 Studies and Other Information on Certain
Perfluorooctane Sulfonate-Related Compounds
a) Final Report, Oral Rangefinder StudyofT-2999CoC in Pregnant Rabbits, Safety Evaluation Laboratory, Riker Laboratories, Inc., Study No. 0680RBO01S, June 25,1981
b) Final Report and Protocol, Oral Teratology StudyofT-2999CoC in Rabbits, Safety Evaluation Laboratory, Riker Laboratories, Inc., Study No. 0681TB0212, 3M Reference No. FM 3924 (88% ethyl FOSE), January 7, 1982
) 3M Internal Correspondence re alcohols being used in Riker studies, from DR Ricker to WC McCormick, dated December 10, 1980
d) Analytical AnalysesofSuspensionof FM-3924, Internal Memo, from TR Mathisen to EG Gortner, dated April 8, 1981
) 3M Intemal Correspondence, Analytical Evaluation of FM-3924, dated June 22, 1982
4) Oral Teratology Study of FM-3422 in Rats
a) Final Report, Oral Teratology Study of FM-3422 in Rats, Safety Evaluation Laboratory, Riker Laboratories, Inc., Study No. 0680TR0010, January 22, 1981
b) 3M Intemal Correspondence re alcohols being used in Riker studies, from DR Ricker to WC McCormick, dated December 10, 1980
5) Teratology Studiesof T-2999CoC (FM-3924) in Rats
a) Final Report, Special Lens Oral Teratology Studyof T-2999CoC in Rats, Safety Evaluation Laboratory, Riker Laboratories, Inc., Study No. 0680TR0020, 3M Reference No. FM-3924, December 22, 1981
b) Final Report and Protocol, Special Lens Oral Teratology Study of T-2999CoC in
Two StrainsofRats, Safety Evaluation Study No. 0681TRO362, July 20, 1982
Laboratory,
Riker
Laboratories,
Inc...
) 3M Internal Correspondence re alcohols being used in Riker studies, from DR. Ricker to WC McCormick, dated December 10, 1980
d) Analytical AnalysesofSuspension of FM-3924, Intemal Memo, from TR Mathisen to EG Gortner, dated April 8, 1981
) 3M intemal correspondence re analytical analysis of FM-3924, from EG Gortner to RM Payfer, dated June 22, 1982
-16-
-
Co1250
Attachments to Letter to C. Auer dated May 18, 2000 Studies and Other Information on Certain
Perfluorooctane Sulfonate-Related Compounds
6)
Memo from EG Lambrecht to Riker Study Developments to Date, dated November 6,
Files 1981
re
Fetal
Lens
Artifact
--
Summary
of
Previously submitted to TSCA Se docket, Final Report, Combined Oral (Gavage)
NFe-rtEitliFtOy,SDEeivnelRaotpsm,en3tMalReafnedrPeenrcienaNtoa.l/TP-o6st3n1a6t.a5l,RJeupnreod3u0,ct1i9o9n9Toxicity Study of
Note: weight amendment.
gain
effects
in
Fy
generation
currently
being
reanalyzed.
Report
may
require
Studies In Progress
1) PLraobtoorcaotlo,ryN,-SEttuFdOySNEo.BiTl-e6M3e16t.h1o5d;DSeTv-e3l0o,pImne-nLitfeinStRaartts,Da3tMe ASturgautsetgic12T,o1x9i9c9o,loIng-yLife End Date August 20, 1999
2) PDreortiovcaotli,veFsec[eNs-EMteFtOhSoEd,DPeFvOeSl,opamnedntFOMSeAtIa,bo3liMsmStSrattuedgyicfoTroxPiercfolluoogryooLcatbaonreastuolrfyo,nate
Study 1999,
Nos., T-636.17; T-6295.21; In-Life End Date November
T2-47,131929.93);
ST-41,
In-Life
Start
Date
November
22,
3) (PrNo-tEotcoFlO,SCEe;ll3PMroTl-i6fe3r1a6t.i1o1n)S,tPuedryflwuiotrhooNc-tEatnheylSuPlefrofnliucoArocoicdtPaontesauslsfiounmaSmaildto(EPtFhOaSn;ol
3M T-6295.16), Rats, Pathology
and N-Ethyl Perfluorooctanesulfonamide (PFOSA Associates Intemational, Study No. 1132-100
3M
T-7091.1)
in
Pre-1976 Studies (bibliography only)
1) Final Report, Oral LD 50 (4 levels), 3M Reference No. T-961, WARF Institute, Inc., Study No. 4043911, June 12, 1974
2)
Final 1260,
Report, Acute Vapor Inhalation Toxicity Study Industrial Bio-Test Laboratories, Inc., July21,
in Rats, 1975
3M
Reference
No.
T-
3)
Final 1259,
Report, Acute Vapor Inhalation Toxicity Study Industrial Bio-Test Laboratories, Inc., July 21,
in Rats, 1975
3M
Reference
No.
T-
4) Final Report, Skin and Eye Irritation Study, WARF Institute, Inc., Study No. 5060080, 3M Reference No. T-1260, June 17, 1975
5)
Final Report, 5060079, 3M
Skin and Eye Irritation Reference No. T-1259,
Study, WAREF June 17, 1975
Institute,
Inc.,
Study
No.
N -17- 01251
A--
T-29911T
3M COMPANY February 2, 1981
JE HAZLe EToN,
G0i252
@ LABORATORIES AMERICA, INC. SPONSOR: 3H COMPANY MATERIAL: T-2991IT
DATE: February 2, 1981
SUBJECT:
FINAL Acute
REPORT Inhalation
Toxicity
Study
in
Rats
Project No. 154-157
1. SUMMARY The test material, T-2291IT, was evaluated for acute inhalation toxicity in rats. Exposure to the test material for four hours at a nominal concentration of 6.57 mg/liter caused sniffing and preening. After 60 minutes of pressure, all animals appeared normal and remained so until the end of the study. Host exposed animals lost weight by post-exposure Day 1, but subsequently recovered. All animals gained weight by the end of the study. Gross pathology findings at necropsy revealed 2 higher incidence of lung lesions In exposed males, but there ware no consistent findings indicative of a compound-related effect. Microscopic examination of fixed lungs, livers, kidneys and all grossly abnormal tissues also failed to reveal com pound-related histomorphologic changes.
11. OBJECTIVE The purpose of this study was to assess the acute Inhalation toxicity in rats to a single k-hour exposure to T-29911T in conformance with proposed FIFRA guidelines (40 CFR Section 163.81-3, August 22, 1978). The study was initiated November 25, 1980, and terminated December 10, 1980.
601258
154-157
@HazesTon
A. Test Material
11. MATERIALS AND METHODS
The test material, T-2991IT, a yellow liquid, was received November 19, 1980,
and stored at room temperature. Information on the methods of synthesis, sta:
bility, as well as data on composi tion or other characteristics which define
the test material are on file with the sponsor. B. Animals and Animal Care*
A total of 20 healthy appearing rats, equally divided by sex, of the
Sprague-Dawley descended strain, obtained from Charles River Breeding Labora-
tories, Inc., Wilmington, Massachusetts, were selected from a stock pool of 24.
Animals not selected for study were returned to the stock pool. The animals
ranged in weight from 228 to 335 grams when selected, and had been quarantined
for at least 19 days prior to selection. Throughout the study, the animals were Individually housed in stainless steel wire-nesh cages with food (Purina Lab
Chow #5001%) and water (via automatic lick valves) available ad 1ibitun except
during exposure. A 12/12-hour light/dark cycle (6:00 A.M. to 6:00 P.M.) was
maintained by automatic timer throughout the study. The exposure was conducted during the 1ight phase. Rats were used in this study because they have histori-
cally been used in safety evaluation studies and are required by FIFRA regulations.
. Grows
The selected 10 animals per sex were assigned to two equal-sized groups by use of a table of randon permutations of 16 (Cochran, W.G., and Cox, G.H., Experimental Designs, 1957) as follows:
ATnheersiecaanniAmsalssocwiaetrieonmaifnotraiAncecdrediintaatniimoanl ofcarLeabofraactiolriytieAsnimfaulllybaraec.credited by the S2-
60i2s4a
154-157
@HazLETon
Seow No, 1 2
Mumbor/Sex 5 3
Treatment Target NominalConcentration
Air Control 5.0 - 5.5 mg/L
0. Exposure Conditions
Group 2 was exposed to T-29911T aerosol in a 100-1iter glass and stainless steel chamber operated dynamically at a constant airflow of 16.7 1iters/minute. Group 1 was "exposed" In a chamber to air only. The compound was generated for 240 minutes as an aerosol by use of a Solo Sphere nebulizer at an aspirator setting of 1003 and operated at an airflow of 3.5 liters/minute.
The aerosol was introduced into the turret top of the chamber with make-up air at 13.2 liters/minute. The exposure was 4.0 hours in duration (plus 30 minutes to allow for chamber purging). E. Exposure Monitoring
1. Aerosol Concentration
2: Nominal: The nominal concentration of the exposure was calculated by dividing the total weight of T-29911T aerosolized by the total volume of air passing through the chamber during aerosol generation.
b. Gravimetric: During exposure to T-2991IT, samples were collected on Gelman Metricel DH-450 filters via a probe extended to the approximate breathing zone of the rats. A sampling rate of 10 1iters/minute was used. Four 15-minute samples were drawn, starting at 60, 115, 170, and 225 minutes after exposure initiation. Weight gain on each filter divided by total volume of air sampled (150 liters) was used to calculate each gravimetric concentration.
-3C01i2Ss
154-157
@HAzLETON | CORRECTED. c. Analytical: The above Gelman DH-USO filters were shipped in sealed glass vials, packed on dry Ice in air-tight packages, to the sponsor for determination of the weights of active material collected. 2. Particle Size Distribution: Prior to and twice during exposure, samples were collected with Andersen A-stage Mini-Sampler cascade Inpactors in order to determine the aerodynamic particle size (mass) distribution of the nonvolatile component of the aerosol In the chamber at the rat's breathing zone. Samples were obtained starting at 60 and 170 minutes after exposure Initiation for 15-minute durations. A sampling rate of 1.4 liters/minute was used. The mass median aerodynamic diameter (MAD) and geometric standard deviation (59) of the mass distribution was obtained graphically after converting the dry weight gains on each stage and backup filter to cumulative percentages of total weight collected and plotting these against the stage cutoffs (in microns) on log-normal (probit) paper. Values at the 50th and 84/50th (or 50/16th) percentile were taken as the mass median aerodynamic diameter and geometric standard deviation, respectively. 3. Temperature and Relative Humidity (R.H.): Temperature and R.H. in the control chamber were measured with an Abbeon Mode! KZAUB temperature and R.H. gauge and recorded every 30 minutes. Temperature and R.H. in the chamber varied from 69F to 75F and 45% to 533, respectively. F. Biological Observations
1. Toxic Signs: Continuously during exposure and twice daily for 14 days postexposure, all animals were observed for signs of toxicity, abnormal behavior, or unusual appearance. Noteworthy changes were recorded.
2. Body Weight: All animals were weighed and body weights recorded prior to exposure and on Days 1, 2, 3, 4, 7, and 14 post-exposure and prior to necropsy.
-h-
01256
@HA AZLET= ON
154-157
CORRESTED. 7,
[--
AIL oninals are killed on Bay 15 post-exposure by sxsanguination under
Ppaetnhtoolboasrybitraelcorsdoeddi.u Cor trace. ings,
m aSpneecsttahlesiaat.tentCioomnplweatse iver, Kidoays, and a
pald to necropsi grossly
ethsewelruengspearnfdorumpepderandregsrpoisrsa sbmorms t1esees sare
fed 0 108 neutral histopathology
buffered
formalin.
Preserved tissues were embedded In Paraplast, sectioned at 5-6 microns,
slide mounted, stained with hematoxylin and eosin, and examined microscopically
I. bcahtaangeSst.orage by a board-certified veterinary pathologist for Indications of `compound- induced
All raw data, specimens, and the final report will be stored In the archives of Hazleton Laboratories America upon acceptance of this final report.
A ferssol concenteasion nn. sesurs
1. Nominal Concentration: A total of 26.33 grams of T-2991IT aerosol were
dispersed into the Inhalation chamber with a total air volume of 4008 liters.
ofThe-znosmgiuniaTl, concentration was, thus, calculated to be 6.57 mg/liter of alr
3.
Gravimetric Concentration: Results tion determinations are show below
of In
the dry weight Table 1.
gravioacric
concentra.
Cs.
01257
@He AzA LsTon
154-157
CORRELTED,
Table 1 = oGfraTv-i2m9e9t1rIiTcACehraomsboelr (dCroyncweenitgrhatt)i.ons
TSaerptre Spghe Asrgotee Srmvigemttriice Initiation
Collected
Airflow
Concentration
60
8.89
150
059
1s
9.13
150
061
170
10.74
150
072
225
10.86
150
072
3. Particle Size Distribution: Results of the particle sizedeterminations are shown in Table 2. The majority of the mass collected was In the res-
pirable size range (i.e., less than 5.0 microns).
Table 2 = Particle size iseribution aca, saple to.
deSNtoa.ge SpE SCiutzoeff
1
>h.7
Sige WCeolllgehctted w= cWoelllgehctted
.18
-03
= CoWelTlgehctted
05
2
<h.7
on
05
07
3
3.3
25
35
52
b
<2.1
.26
F
<0.65
03
15
32
00
02
T
83
58
-98
MMAD (uw)
2.6
2.4
2.35
og
o tori
2.00
1.33
1.47
No anise dled during this stud.
-6=
601258
154-157
@HAZLETON
. Toxic Signs 1. Group 1 (Air Control): All animals in this group exhibited normal appearance
and behavior throughout the study.
2. Group 2 (6.5 mg/L): After one minute of exposure, all animals were observed
to be sniffing the air, and after flve minutes, all animals were preening.
All animals appeared caln and normal after 30 minutes, and all animals ap
peared normal after 60 minutes and throughout the remainder of the exposure.
All animals exhibited normal appearance and behavior throughout the 14-day
post-exposure observation period. 0. Sody weights
Individual body weights with group means (:5.D.) are presented in Table 3.
Most Group 2 animals lost weight after exposure, but subsequently recovered.
AIT animals gained weight by the end of the study.
E. Gross Pathology
Gross pathology findings at necropsy are presented in Table 4. There was
a higher incidence of lesions In the lungs of Group 2 males, but there were no
consistent findings indicative of a compound-related effect.
F. Mistopathology Microscopic evaluation revealed lesions of chronic respiratory disease
consisting of peribronchial and perivascular lyphold hyperplasia and focal
pneumonitis characterized by focally thickened alveolar walls and a pleocellular
inflammatory infiltrate, including alveolar macrophages. These lesions were
essentially comparable in incidence and severity between control and treated rats with the exception of the control females, In which lesions were slightly less prominent. Histopathologic incidences are presented in Table 5.
.y-
01259
@ HAZLETON
154-157
Lymphoreticular cell hyperplasia was present in the various lymph nodes examined
a1nyd8phwasnodaeccoofmpaanneiecdonbtyroclonfgeemsatlieo.n anFodciPpiogfmeangto=nlaaldenhemmoarcrrhoapgheagewsereinnottheedmeidniatshtyimniacl sections of three rata.
In conclusion, alcroscoplc evaluation of hesstoxylin and eosin seained sections of Tung, liver, Kidney and unusual lesions From control ang treated
rats from an acute inhalation study with T-19911T failed to reveal compound-
Submicced by:2
-8-
CO1260
154-157
Table 3 - Body Weights (grams).
Animal No./Sex ~~ Pre Day 1 Day? Day3 Dayh Day7
GROUP 1
479314 479324 47798234344 47935
321 313 32 31 32 ub
341 30
301 325
343 Ed 323 328
348 331
32649h
522 320 328 334 33 532
323 323 329 338 340 357
2M5e.a0n.
325 32 329 336 336 353 8.8 8.5 8.c 7.8 9.1 10.4
447739337622 447739338528 L73k0% 2M5.e0a.n
227315 225863 275 26148.6
227318 22k706 227430 226386 228306 225960 22961 226901 225778 292610 280 275 283 275 275 26270.5 26189.8 26290.1 . 26147.8 22618.3
Dayih
382 8381 386 395 390 13 286 243 228666 284 273 18.8
4477934k124d 747333uhdd. 4735S H5e.a0r.
479462 473472 479483 447733540988 5M.e0a.n
GRP 2
33530 33319 332487 335337 335348 338756 3n8k2 34s 319 33 342 343 362 401 335400 334258 335307 334568 335472 336833 440253
3464 2
3219.2
3339.0
3478.4
3478.2
36n8 a
405 154
248 237 233 233
237 24 233 239
224338
22u369
225442
242 21 242 249 256 258
22562 225441 2206k0
227509
278 265 278 282 270 279 283
25115.5 24163.6 25117.3 251281 24193a 25146.2 26137.8
-5-
012861
Table 4 Gross Pathology
OBSERVATIONS
NO GROSS LESIONS
LYHPH NODES
Tracheal bronchial:
appear enlarged
Cervical:
left appears enlarged
Hediastinal:
lleefftt left
aappppeeaarrss appears
erneldadregneedd enlarged
and
granular
right THvas
side
appears
enlarged
pFlueifrgthptlseisdifedoecirerdeddedneended
Lunes
ALI Lobes:
nSscucamatettrteoerureseddpwarhledietaearreefaaossci on surfaces
patchy appearance
Right Diaphragmatic Lobe:
cdoonrssaollidsautrefdacelihnaesartawroeabltahcakt fdoicid not perfuse
Right Apical Lobe:
did not perfuse
Left Lobe:
antbyeraiorpalteiparheaas dark reddened area surrounded IInstnceartntteedrieeadterraaendnmdaLrLeeeefaftsdLaoLntaiteevrreaanltLrtaoLlbobeeesssu::rfaces cecum Red area, probable injection site Kiowevs DDaarrkk ezoornteicion -comretdiuclola-rymeadruelalary area UTERINE HORNS AAppppeeaarr dtihsitceknedneedd with clear fluid C(0oizeesz.
-r0-
154-157 Findings
oo Groups TT = Tx us ws us us
5 5 7s
17753
u1s3 573 5
5
s 1i5s
7vss 5 vs 5 15
5 us vs us vs 5
5
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HISTOPATHOLOGY INCIDENCE IABLE
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154-157
@HAzLETON
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REPORT [rea PREPARATION:_
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INHALATION SUPERVISOR: ROBERT 32 HoT
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TECHNICIANS: AKILMABLAE,, DK.. TTRRAAMMNAEELL,, HBEONWREYR,S, GURIYFFEY, REDDEN, HAND,
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00165
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OFFICE OF QUALITY ASSURANCE
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Project Title: Acute Inhalation Toxicity Study in Rats Project No.: 154-157
reported to nanagenent and to the study director on the following rQeupaolrittyoAfssthueraanbcoeveinrsepefcetrieonncsedofprtohjeectstwuedryeacndondruecvtieedw oacfcotrhdeinfginatlo
the standard operating procedures of the Office of Quality Assurance and according to the general requirements of the Good Laboratory Practice regulations that were issued on December 22, 1978, by the Food and Drug Administration for compliance on and after June 20, 1979. Findings from the inspections and final report review were dates:
Inspections/Review
Findings Reported Inspector/Reviewer
Study - 12/10/80
Final Report - 1/26/81
12/11/80
2/2/81
E. Prins
K. Hogan
Man=ager --
Office of Quality Assurance
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