Document X7d7eOBZqN0L57396a165Knny
HAZLOZON
LABORATOIQIES
ANAERICA. lrJC.
3301 KINSMAN BLVD. P.O.BOX 7545 MADISON, WISCONSIN 53707
Chemical& BloMedicalSciencesDivision
PHONE (6W)241-4471,T!:@,
-1-WRAL MDS UD
REPORT OF ANALYSIS
W. C. MCCORMICK MINNESOTA MINING AND TOXI COLOGY SERVICES ST. PAUL, MN 55101
MANUFACTURING
SAMPLE: T-3607 PURCHASE ORDER NUMBER: P-688709-405
SAMPLE NUMBER: DATE ENTERED:
REPORT PRINTED:
407039S 07/19/E 10/05/':--"
ENCLOSED:
ACUTE ORAL TOXICITY RAW DATA APPENDIX
STUDY
METHOD, SUMMARY, PATHOLOGY
SIGNED:
STEVEN M. GLAZA STUDY DIRECTOR ACUTE TOXICOLOGY
BY AND FOR HAZLETON LABORATORIES AMERICA, INC.
RAW DATA FOR THIS STUDY ARE KEPT ON FILE AT HAZLETON AMERICA, INC. MADISON, WISCONSIN.
LABORATORIES
IF,Wal HAZLC%CN
LAeC)RATC3RIES
AIVERICA. INC.
Chemical& SloMedIcalSciencesDivision
3301 KINSMAN BLVD. 9 P.O.BOX 7545 o MADISON, WISCONSIN 53707 o PHONE (608)241-44710 TLX 703956HAZRAL MDS UD
SAMPLE NUMBER: 40703983 SAMPLE: T-3607
PAGE
2
ACUTE ORAL TOXICITY
Test Animal: Youna adult male and female albino rats (approximaftely 7 weeks of age) @'f the Sprague-Dawley strain were procured, maintained in group cages in temperature- and humidity-controlled quarters, provided continuous access to Purina Rodent Chow and water, and held for an acclimation period of at least 7 days.
Acclimated animals were chosen at random for the study. Test animals were housed by sex in groups of five and identified by animal number and corresponding ear tag. Food and water were available ad libitum throughout the study, exceot for an overnight period just before test material administrati@n when food, but not water., was withheld.
Reason for Species Selection: The rat is the animal classically used due to its small size,. ready availability, and large amount of background data.
Method: Five male and five female rat5 weighing between 202 and 231 9 were Used for a single dosage level of 5.0 g/kg of body weight.
Preparation and Administration of Test Material: An individual dose was calculated for each animal based Upon its fasted body weight and administered undiluted by gavage. The d05e volume was "-@.76ml/kg of body weiaht based upon the average bulk density Of 1.81 g/Ml.
Observations: The animals were observed for clinical signs and mortality at 1., 2.5 and 4 hours following test material administration. The animals were observed daily thereafter for 14 days for clinical signs and twice daily for mortality.
All animals were weighed just before test material administration, at 7 davs and at stud,.,termination.
Pathology: At study termination all animals were euthanatized, subjected to a gross necrop5y examination and all abnormalities were recorded.
IFIVH,A4Z1LR;OCCN LAaORATC)PiES Atvlr=RICA.iNC.
Chemical& BloMedicaSlciencesDivision
3301 KINSMAN BLVD. a P.O.BOX 7545 o MADISON. WISCONSIN 53707 o PHONE (608)241-4471 TLX 703956 HAZRAL MDS UD
SAMPLE NUMBER: 40703983 SAMPLE: T-3607
PAGE
ACUTE ORAL TOXICITY
(CONTINUED)
SUMMARY
Test Animal: Albino Rats - Sprague-Dawley strain Source: Harlan Sprague-Dawley, Madison WI Date Animals Received: 07/24/84
Method of Administration:
Oral Gavage
Date Test Started: 08/03/84
Date.Test Completed:
08/17/84
Estimated Oral LD50:
Male - Greater than 5.0 g/kg of body weight Female - Greater than 5.0 g/kg of body weight
Mortality Summary (Number of Deaths)
Dosage
Level (g/ka)
,3.o6
Hours 0-4
mF
00
Days
1
2
3
4
5
6
M F M F MF MF MF MF
00 0 0 00 00 00 0a
7-14
MF
00
Total
m F Both
0/5 0/5 0/10
Average Initial
Body Weights (9) Day 7 Terminal
Male
221
276
295
Female
210
226
231
PATHOLOGY
Animal Number C21437 C21439 C21434 C21433 C21432
C21521 C21503 C21522 C21523 C21524
Test Day
Sex
Died Sacrificed
m
-
14
m
-
14
m
-
14
m
-
14
m
-
14
F
-
14
F
-
14
F
-
14
F
-
14
F
-
14
Necroosy Comments
No Vi@ible Lesions.
No Visible
Lesions.
No Visible Lesions.
No Visible
Lesions.
Lungs - multiple, raised,
on all lobes, pinpoint to
diameter.
No Visible
Lesions.
No Visible Lesions.
No Visible Lesions.
No Visible Lesions.
No Visible
Lesions.
grey mm
foci in
Reference: Hitch, R.K., "Acute Oral Toxicity Study," Pesticide Assessment Guidelines, Subdivision F, Hazard Evaluation: Human and Domestic
Animals, U.S. Environmental Protection Agency Office of Pesticide and Toxic Substance Series 81-1, pp. 34-39 (November 1982).
Stud-yTitle:
Test Article:
Dosage Level:
Species:
Io
Dos* Tim:
GROSS CLINICAL OBSERVATIONS
izje-
7-n)(i,''@Iedt
RT t4o-
IVA
Vehielt:
AIA
Sax:
Observati=s i-b19-4SLZ> 1
Ame=ed normal
of Animls Affected/CYboarvaticmPeriod D&TS
2 3 4 5 6 7 1 'g 9 101 U 12 Ul 14
6 1<
Tachnicisn
M h*O
IDate
94 @,L'r)/,@
NA - Not applicable
RE a Not evident
C c> 0 co(Olo
0 ololoo
c>o
V, - [?,n
I sk6-1
F7 Fk-'I"hNIDI3i1i-I
th@@i,iYi'71
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Date: 'T-(3 tz/
StudY Title: Test Article: Dosagt Level: Species: Dose Time:
GROSS CLINICAL OBSERVATIONS
)7tii4,lv@@rei76jX@@l'@'@4
i-
RT No.
Vehicle:
AIA
Sam:
Observations Asmwwed norml
30=3
N=ber of Aui=Oj Affected/Observati*nP4wiod Davs
3 4 5 6 7 8 1 9 101 111 1 2 13 14
.2eaths
Tacb-4
Date -LQ-SL
MA - N
le
LqZ Not evidmut
Rarieved by:
411D @ll
T@,L@
IV17
Data:.9-/a-q4
0
ACUTE ORAL TOXICITY (LD50 ) RECOKD
Test Material -r-,31.0,p:z
Vehi 1 AJA
Ri
Bulk Density
(g/ml) Species kn-t-
Source
CLoq
Date Rece
Dosage
C) (it/kii)
Dose Volume ol 76,(m
Sex 'Animal No. Ear Ta
Pretasted Body Weight (g)
Fasted: Date '9-.-A-S4Time
tiqdI
Dose Time
lq34 i-43a ij
Tech.
Ro
Tech. Dat u,
Fasted Body Weight (g)
Actual Doso (mi
b.M
aua--
Day 7 Body Weight (9
Day 14 Body Weight It- --1
Doses Verif @bedl
Dosage Dose volume
(R/kR)
(ol/kg)
Animal No./Ear TaitNo.0,2,
Prefasted Bodv Weight (it)
--M-. "
Fasted Body Weight (g) .118-.i2l&
Actual Dose mi
b,tab
Day 7 Body Wei&ht (R)
Day 14 Body Weight (R)
232'
0
i3aTi
Tech.----Dal
P. *@
-DONOR
0 varifloa
wi
p-
09
S L.;,
h3Et eAA&-
loDDe_:ovs,eeel] l.ev'el
liours
0-4 am_
MORTALIT@ (NO. DIIED/110.DOSED)
-23
am I)M
v Dav
6
7
8
9 1 10
1 IL SUL
Teciinfcia"n
tilr-t A6 llb jam-bm).
Datetqi NA - Not Applicable An
7
re'I? p
- Dosage calculated, but not administered . .1'..-1."-.I..@.@1 I-, -fn-@If
cy@ 'log -ka 16 4p-i@
Reviewed by