Document prkJnXdOmjRMn9eaDY7BQRmd
5
International Research and Development Corporation
SPONSOR:
TEST MATERIAL: SUBJECT:
3 Company
Fluorad Fluorochemical FC-143
ASctuutdey OirnalRatTso.xicity ng)
Whi
WiDilrseocnto?r.DofeaAmc,ute8.4T.oxicology and Special Studies
(Study Director)
'
4
a5ssocTiIacEhToflDirJeecstsouyp AF Rohe.Ds. earsa
Collaborators: GaGrryouTphomTpescohnn,icaBl.S.Supervisor GrCeogieRoTmeic,hni3c.5a.l Supervisor DavUniide PoSwueplelr,visBo.rA,.
ARceupotret anPdrepSapreactiiaoln,Studies Departaeat
Date: May 5, 1978
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International Research and Development Corporation TABLE OF CONTENTS
TooSymopsis cL. .........................
Page 1
IL TestMaterfal . ........................ 2
TIL Method oi... 3
I. Results iii. 4
A. MorcanadLlDjiyVatluyes . . ............... 4
B. Pharmacotoxfc SLES . .. ................. 4
CoBody Welghts . ....................... 7
D. Necropsy Findings . . ................... 8
1. Rats which died during the study perfod . . . ..... 9
2. oRbastsewrvhaitcihovner.e.s.ac.ri.fi.ce.d.f.ol.lo.wi.ng.14..da.ys.o.f .... 11
Table No.
1. Pharmacotoxie SINS . . . i... ............ 5-6
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Page 1
1. smopsis
Based upon the daca obtained, the acute oral LD) values and 95%
confidence limits vere calculated to be as follows
1
Male Rats: 680 (399 - 1157) mg/kg.
Female Rats: 430 (295 - 626) mg/kg.
Combined Male and Female Rats: 540 (389 - 749) ng/kg.
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Page 2
IL. TEST MATERIAL The test material was received fron the 3 Company, St. Paul, Minne-
sota ou October 24, 1977. It was identified as "Fluorad Fluorochemical FC-143, 3M Stock No. 98-0211-0008-0, Lot 340" and was received as a white powder.
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Page 3 mI. wEmHoD
Twenty-five male and 25 female rats of the Charles River CD strain (obtained from Charles River Breeding Laboratories, Inc., Portage, Michigan), weighing from 180 to 221 grams, vere used for this study. The rats vere housed by sex in groups of 5 rats per cage, in hanging wiremesh cages in temperature and humidity controlled quarters. They were maintained in accordance with the recommendations contained in H.E.W. Publication No. 74-23 (N.I.H.) entitled "Guide for the Care and Use of Laboratory Animals". Water and Purina Laboratory Chow vere available 2d Libicun, except for an overnight period immediately preceding oral adainistration during which food, but not water, was withheld.
The test materisl vas administered orally by gavage as an emulsion" in 40% acetone/60% corn oil at the following dosage levels to male and female rats: 100, 215, 464, 1000 and 2150 mg/kg.
Five rats of each sex were used at each dosage level. Volumes of 10 ml/kg of body weight vere administered at all dosage levels.
ALL rats vere observed for mortality and pharmacotoxic signs during the firse four hours after dosing, at 24 hours and daily thereafter for a total of 14 days. Body weights were recorded immediately prior to dosing (control weight) and at 7 and 1 days. All rats which died on study vere subjected to gross necropsy examination as were all survivors at the end of the 14 day observation period.
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International Research and Development Corporation
w. morts omans wns:
Dosage Level
=
215 464
1000 2150
|Hrs|
Total Mortalities
TT]
0/5
22
1
2/5
13/4 22 2 2 11 53//55
Tu scare rs) 0, tans en 95 cnet Coie Male Rats: 680 (399 - 1157) mg/kg. Female Rats: "430 (295 - 626) mg/kg. GoneCombined Male and Female Rats: 540 (389 - 749) mg/kg.
em [oe
0/5 0/10
3/5 5/10 5/5 8/10 5/5| 10/10
Lyei1, C. S. 1952. Tables for Convenient Calculation of Median Thompson, W. R. and Weil, C. S. 1952. On the Construction of 3eby, R. 1957. Statistical Tables for Dose Evaluation, Report No.
hanes ectots ome Sete 1
00043
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International Research and Development Corporation
Page 7
c. ovr eres:
The follouing body
tion pertod:
LDeosvaegle Individual
(mg/kg;
Rat Number
100
7678688898
7676889901
76892
7766390089
7766901101
76912
215
767869839
7676889965
76897
7766991143
7766991156
76917
464
7766889998
7766990001
76902
7766991198
7676992210
76922
1000
7766990034
7766990056
76907
weights vere
Sex
vvaallee MYaallee vale FeFmemaallee FFeemmaallee Female vvaallee MNaallee Nale FeFemmaallee FFeemmaallee Female Mvaallee yYaallee Yale FeFmemaallee FeFezmaallee Female rvaallee vvaallee rate
obtained during
WCeoingthrol
grams;
11899 211900 198 119982 128046 188 222163 22120 203 181925 118950 182 220125 221168 200 118800 119822 194 119848 118962 192
the 14 day V7etDgahye
(grams;
222682 Di26e0d 26 221127 220258 191 226667 225542 23% 220138 220095 203 Di2e9d D2i3e5d 25 Di20e0d D2i0e4d Died Di20e8d DDiieedd 223
observaV1e6tgdhaty
(grams
22795 D2i85ed 304 222660 224247 212 333108 2391%2 208 2233 22320 236 D3i3e0d D2i9e6d 302 D2i2e7d D2i2e3d Died D27i0ed DDiieedd 200
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LDeovsealge Individual
(ag/kg) Rat Number Sex
1000
7766992234 FFeemmaallee
7766992265 FFeemnaallee
76927 Female
2150
7777220089 Mvaallee
7777221110 vMaallee
7212 vale
7777221134 FFeemmaallee
7777221615 FFeemmaallee
7217 Female
D. NECROPSY FINDINGS:
Gross necropsy observations were
un.
VCeoingthrtol W7eDiagyht
(grans) (grams)
128002
DDiieedd
118568
DDiieedd
196
Died
221063
DDiieedd
220181
DDiieedd
213
Died
22113
DDiieedd
22197
DDiieedd
206
Died
noted as indicated on pages
W1e4igDhaty (grams) DDiieedd DDiieedd Died DDiieedd DDiieedd Died DDiieedd DDiieedd Died 9, 10 and
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sor eer [even] ee ertieee ree
mmm TLlT llan SLr7 ungms,eepeieced TT T TTT TT lT 7 AlTads
erosion
1/3
ral TT1 1111
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Nuaber ExhiDboistaigengLeSviegln/N(ummgb/ekgr)Necropsied
Sra [So Tremone ree we[refeTeeTe re
gm |TTTT1] fluid filled
2s| ws
sg | TTT coloration
Parctoanlilbya,ltzed|| 1a/1l
Redarosutnadtnnose/ zouch
us us| ws
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Page 11
ston: 2. Rats which were sacrificed following 14 davs of cbservaNumber ExhibDiotsiangge LSeivgenl/Nu(snbge/rkg)Necropsied
SGrroesesnaNrecirnoep:sy
No gross lesions Lungs, foct ened
reaucosa, hyperenia
Uterus, hydronecra
Sn coloration
[vate ems ate remae vai reste[te [emai---
LTT TT san ul LTTTs
wel sis| ssl ws| asl
lal ul l TT us
us| ys
ITas Tas
[anlanlweLal To] 2/4 2/5 3/5
1/3
age | ape 12
17
1/2
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