Document 917KRn4y2E8gwMjnxQzEkdk9p
HAZLOTON -mgm-@Av-L,Ec,s,,
3301K SMAN BLVD. P.O. BOX 7545 - MADISON, WISCONSIN
53707
Chemical& BioMedicalSciencesDivision
PHONE (608)241-4471 TLX 703966 HAZRAL MDS UD
F J,14AL REPORT
F
Pi-)i;FP PFR@,'T@4!:;
rijt4@4FcnTA rIJ@JTtIG
TOXTt7Ol-Of7,'@' SFR@)ICES .ST. PAUL., t'lN 5c52Ol
MANUFACTURING
COMPANY
SArlPLE:
T-40-16
PI-IRCHASE ORDER NUMBER: TP,77389-410
712
SAMPLE
NUMBER:
SAMPLE ENTERED:
REPORT
PPT.NTED:
7010031,@,-7 01/'07,,S-
F t,Cl L 0 S F,17): ACLJTE ORAL TO"'-"ICITY STUDY PAIAI DATA APPENDIX
IN RATS
PLETHOD,, SUMMARY.,
PATHOLOC@'i'
,/ ...........
STEUEN M. GLAZA
i
STUDY DIRECTOR
ACUTE
TO'@llI COLOG'T'
......... DATE
..........
BY At4D FOR HAI-7LETON LABORATORIES
AMFRJl-7A, INC.
PAIAIDATA FOP THTC, STUDY
gt,lFP117A". l@@C. , MADISON,
ARE KEPT O@4 FILE LITSCON--Ilfl.
AT HAZ7L-ETOt-A LABORATORTEC
HAZLETON
LABORArORirzs AftAERicA, iNc
3301 KINSMAN BLVD. - P.O. BOX 7545 * MADISON, WISCONSIN
Chemical& B!oMedicaSlcienceDsivision
53707 - PHONE (608) 241-4471 - TLX 703956 HAZRAL MDS UD
tALIrIF-.:FP.,: 70101@71;7
t,lP'L F
T-4016
pA(-F-,
Af7lJTF ORAL
Ti-iX I f--T T@f'
Oh .1e r7t ) k@p-:
Tc- determine
the acute
oral
toxicity
produced
when
a test
material
is admini--,ter-ed
bv the oral
route
Coavaoe)
to rats
according
to
the U.S.
Environmental
Protection
Aqenc,,,'s Guidelines
for Testing
Pe!--.ticirle-- and Toxic
Substances.
Test tlaterial:
T- .40 1r@,
Ph-,,-,isc a I Cies c r ip t ic,n
Pi ir i t k, An r, C@t
Thick- brown
liquid
a-,5uries
stability
determinations.
pur, t-- 7:t-,-
TF--s t
Ari i ma I strain
Young
adi-ilt male
ijer-e procured,
and female maintained
albino by sex
rats
of
in group
the Spraque-
cages
in
tempe ratijre-
and
I,r) Pijrina
Roderit
@iumidit@)-controlled 17.hoi.,aind Liater
and
quarters.,
held
@ or
provided
continuous
an acclimation
per-iod
at least
7 dak,,s.
access of
,L'4r-climated animal@@
6iF--rrzchosen
at random
for the study.
Test animals
i.,ier-Phoused
by se-, in groups
of fi,,je and
identified
by animal
number
and
r,;orrespondinq tht,nua@ic,ut
the
ear taq. stud@,,,
Food except
and for
water
were
an overnight
akdailable period
ad iust
libitum before
test
material
administration
i,jheri forid., but not water,
was withheld.
F,P-a=,on @or Species
c-electicin:
T@ie rat is the anirrial classically
used
due
to
itc, small
sizr--. read@,., a,,)ailabilit,,,,,
and
large
amniint
of back-.groijnd
data.
t
rl
Fi,,.,e rrialr- ar:d
@F-m;:@le rat--.
@r,r a sinqle
d,-3saqr-- le,.,el n4@ 5.0
+r-- '-c)-7 q
Pt--eparation
and
calculated
and administered
Admirii--tratiori
of Test
rlaterial:
for each
animal
based
upnn
it-.
iindiluted
b,,, ga-,)ao,e.
An individual
d05e
fasted
body
welqht
The do-le ,,,olume 1_jric,nari awerarie
of t@-ie test Liulk
matc-r-ial of 1.06
was o /rT, I .
rril,'kq of bod@,) weight
basp-d
fr)r R'oiite of Administration:
a @@rioi,inouantitt,)
cif tc-7@t substance
This and
is t[-ie method
for
@-ias been
t@-ie route
administering of choice
.
I- 0'b@* HAZLOTON
3301 KINSMAN
--sc@-Es ..
BLVD.
P.O. BOX 7545 o MADISON,
WISCONSIN
Chemical
& BioMedical
Sciences
53707 o PHONE
(608) 241-4471
TLX 703956 HAZRAL
Division
MDS UD
-cl;-@rlPLF
N!-IrlBFR:
7Fill@03177
pAf;F
r1p 1,,17-
-7-
Af'-,I-ITEOPAT- TC-I'l-lif7TT'i'
COt4T TNIJER.)
Ob F.e r @,a t i o ri@.: The animals wer-e obser,,,ed for clinical 5ions and mortalit@,l
at *11.
and 4 hours
after test material
administratic)ri.
The animals
lAlf@,rto@bsert,.,ed
thereafter for 1.'4days for clinical 5ioris and twice
dail@,) for mortalitk,,.
All animals i@ip-rci-,lel.cihediust before .Clijr,,,,i,,a,njinmca,ls wer-e weia.@ied again
test material adrciinistratior.. at -7 days and at study termination.
Patholog@.,: ;-ir,imals
At stijdk) termiriatior, sijrvi,.,,inganimals were euthanatized.
died durinq the study or were euthanatized
recei,.,,eda
necropsk.1, examinati.ort and all abnormalities
werr-- recorded.
H Az LUTON
330K1INSMABNLVD-.P.OB.OX7545MADISON,
WISCONSIN
53707
Chemic&aBl!oMediSccailencDeisvision
PHONE (608)241-4471 TLX 703956 HAZRAL MDS UD
SAt,lP@ F: T - 4,4Ci'Ifg,@
77
PE
ACI l-7E !-IPAL TO@,'lC ITl,'
SUMMAPY
CL-ITJTI NLIED
Test i:-inimal: Albino Rats - I-prao,ue-Dawlek,,lstr-ain
Source:
Charles Rl,,,,erI--aboratories, Inc., Portaqe
MT
1 [late @4riirrialER.ecei,,.)ed:
tIF-thorJof 4)dmiriistrat ion: Oral Ga@.,ane
[@@-te Test Started:
Date Test 1--ompleted:
01
Estimated
Oral LDC50:
Male - Greater than r-.0 q,,*kq of bodk., weiqht Female - Greater than c7,.O c3/@-,qof body weiqht
Dosage Lewe I
Male
0
FF-rriaI e
1-@
A@.,f--raqe Bod,,) ltleiq@its(q)
Initial
Da@,' 7
Terminal
264 2 li9
321; 1,I'@,
3(,l @3 ,
- 44
Mf:)rtalit,,,j(Number Dead,"Nijm@er Dosed)
01,15
11,15
Hi-)iir s
Clinical Sions
7
C@,
Da @)s
-1
'1,
'1
@'laI e-
P,r-jpeared Norma 1 4
4
5
F,
17@
5
71
@7,
5
F
15
H.
Fjr-:t 1 j t
0
0
0
ID
ID
ID
0
0
0
0
0
0
0
0
;'ed-stained f ;:17p-
1
0 0 0 0 0 0 0 i) 0
0
0
0
0
cl
r:e s E-, ,.,e s a i @.,at ion
0
0
1
00 000 0 0 0 0
0
0
0
0
Ferria Ie s
i "Z
r-, t i t k',,
H
g in e d a c-.e
44
44
I 1 0 0 0 0 ID 0
0
0
0
0
0
1
0
0
0
0
0
0
0
0
0
0
0
F .1a@ I i,,,,ta i,on
t a.@:1 a Fr,,,3icat ion
a t @-,
0 00 0 0 0 0 0 0
0
0
0
0
0
C,
0
0
0 0 1 0 00 0 0 0
0
0
0
0
0
0
0
iD
0 01 0 0 0 0 0 0
0
0
0
0
0
@i
ci
0
00 1 0 0 0
0 ID
0
0
0
0
0
Fi-iiintd@p-ad in Fi.M.
HAZLOTON
LABCNXVRIES
Atl,*RICA. irC
Chemical& BioMedicalSciencesDivision
3301KINSMAN BLVD. o P.O.BOX 7545 - MADISON, WISCONSIN 53707 - PHONE (6082)41-4471 TLX 703956HAZRAL MDS UD
t4I-1M E?F.F-':7 fi1ID1-7,F
T - .-r,i r,
F i@:F,
r--
A'-1-ITE OF-'tL@L-Tl-l'*I-C' IT'i'
Dc,sacp Le@,r--I
An irriaI
r4ijri)bre
S F-.
ri
c 3 el0
Cr. 43
c F,
F
C@ 5 2
F
F
-7 1;
F
I-r@@ F, 'I C.7
F
COT-AT I NIJEE!
P A T H IDL
r@7
ci,k,r3 o f b o d
Te@zt Da,,) Died Sacrificed
we Iri@i
Necrops,-j Ccimment@@
C @ - - - - @-
c c - t-a i ri@i d
firm,
rubber@,1,,
porous
r materia
Stomach @ i r m.,
- corit a i rts derk,-brr,)i@in r u b b r= r,.,,), p ri r o u s rria t P- r a a
14
Stomach - contains
dar-k,-Lirot@ir@
firm.. rubbery,
pn-rr7sus material.
Stomach - contains dark, fir-m., rubber-,,,),p,orous materiF-1.
Stomar-,@-i- cor-itains dar@-.-brrji,ir. @ir-m, rubber,,,,, por-nus material.
Stomach - contains
dark- -b r-oi@it-i
@irrri,,rubbery. pornus materia
ulcerated
arr--as on nono,lanrJ;Alar-
D n , t , - ;.
t riMe3
C:(Dr-it a ,n -@ d a r @jr r-iL@ir-) rubber@,,,, pc,rou-- meteriai.
t (Dma r.@-i - c 1,r3-ti a in@@, I r-m , r iib b r-r-,,..@. cic,roij@E,
rnigteria 'i
Storriar-@-i- r-(7jr)tien,-. i r rr,i r ;jb b e.r,",, r)o r ciii n-iat e r )a
ulcerated areas or-,riorir3latidiilar p c,r t i r3ri.
Strjrnar.F,- cf-intairis dar-k-br-rii,in f i rrri,,rubbery, por-cj:js rnater ia a t-di F-x- h ib ite d d I ff 11.e5@I r e id a r-e a s ciri q Ia n d i-i',a r p c,r t i rDri. F,n.r@, iiI r-e-,r a t F-ri ar-L-aE-, or, o laridu Iar and n.--IngIaridii lar .or,r-,ti i o ris .
@@.-'HAZLGICCLANBOPATORIES AftAERICA.INC
Chemical& BioMedicalSciencesDivision
3301KINSMAN BLVD. 0 P.O.BOX 7545 - MADISON, WISCONSIN 53707 - PHONE J608)241-4471- TLX 703956HAZRAL MDS UD
pA
-F t4l-lrlRFP: l@I n 1--,.c7'@ - : T -.4 f@,l@
Ai-IJT=I- t)P'H'I- Tf7l,,'Tf-TT@'
(COt4T I TAUEE,
Rp@erenc:es:
i
H,@ t
P. 11".
Ar--itir--Ora I To x ic i
ijdkl,"t,.Re.-,t i r-i-de Asse5.smen t
,,Iji de I inF--s @-;u@jriJ-,j)s ion F Haz a rd E,,)aIua t ion
Human and Dorpes t i c
(-@n
Is , IJ.1-n. Enk,,i rcinrrir-t-an I Rrn t er-t- i-nn AqF.--nc-,@Of f i ce o f Pes t Ic ide
and Toxic. C-,ubstarice Series 8'1-1, pp. 34-39, No-,.)ember 190-"@'.
e-)1 rC7 p r-C@
Laborator@,,
r 1 1,, 4-- -j -@@- -tI - -
D-lic Adr,-;-,:@=,@-@l;---.@-,'::,
Pract ices Peo,ulatiori--@for tionclinical Laborator@j
Studies').
7. DHHC- Pijblicatinr, Nri. (TIIH eF,-23 19P,15) Gijide for thp Carp- and U--,p ci@ Laborator-,) Animals.
old
Lo
-i E
a
00
Lt
10
.........
.it rc
a
30.
cc -So,
@Lc
C6
a. a is
0
cri to
41
H t-
-0 CO z
filll@I lI
0 C4
ri
0.0
Ira.
Irv.
Aj
CL
t)O
CL
IU
ul
I I ltV IW4 en
-71
1 11
cc>;1' 114H
11 1 L r*- I IIL
cn
t I I 111
V Nil
I I r@>
11
I Nil1 -1N 11 11 NI ]Ill]]III
IN
0 0 -1
0
fl
'00