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HAZLETON LABORATORIES AMERICA, INJC.
M O trO U n
Chemical & BioMedical Sciences Division
3301 K IN S M A N BLVD. P.O. B O X 7545 M A D IS O N , W IS C O N S IN 53707 P H O N E (608) 241-4471 .,-TtX 7 0 3 9 5 6 > IA Z R A l M D S UD
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REPORT OF ANALYSIS
W. C. MCCORMICK MINNESOTA MINING AND MANUFACTURING TOXICOLOGY SERUICES ST. PAUL. MN 55101
SAMPLE: T-3607
PURCHASE ORDER NUMBER: P-688709-405
SAMPLE NUMBER: 407039 DATE ENTERED: 07/19/
REPORT PRINTED: 10/05/
ENCLOSED: ACUTE ORAL TOXICITY STUDY - METHOD, SUMMARY, PATHOLOGY RAW DATA APPENDIX
SIGNED:
STEUEN M. GLAZA STUDY DIRECTOR ACUTE TOXICOLOGY
U
BY AND FOR HAZLETON LABORATORIES AMERICA, INC.
RAW DATA FOR THIS STUDY ARE KEPT ON FILE AT HAZLETON LABORATORIES ' AMERICA, INC. MADISON, WISCONSIN.
000074
Chemical & BioMedical Sciences Division
3301 K IN S M A N BLVD. P.O. B O X 7545 M A D IS O N , W IS C O N S IN 53707 P H O N E (608) 2414471 T LX 703956 H A Z R A L M D S UD
SAMPLE NUMBER: 40703983 SAMPLE: T-3607
PAGE
ACUTE ORAL TOXICITY
Test Animal: Young adult male and female albino rats (approximately 7 weeks of age) of the Sprague-Dawley strain were procured, maintained 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.
in
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 taq. Food and water were available ad libitum throughout the study, except for an overnight period just before test ma terial administration when food, but not wa ter, was withheld.
Reason for Species Selection: The rat is the animal classically used due tc its small size, ready availability, and large amount of background data.
Method: Five male and five female rats weighing between 202 and 231 g were used for a sinqle dosage level of 5.0 a/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 admin istered undiluted by qava ge. The dose volume was 2.76 ml/kg of body weight 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 days and at study termination.
Pathology: At study termination all animals were euthanatized, subjected to a gross necropsy examination and all abnormalities were recorded.
000075
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HAZLETON LABORATORIES AMERICA. INC.
Chemical & BloMedlcal Sciences Division
3301 K IN S M A N BLVD. P.0. B O X 7545 M A D IS O N , W IS C O N S IN 53707 P H O N E (608) 241-4471 T U 703956 H A Z R A L M D S UD
SAMPLE NUMBER: 40703983 SAMPLE: T-3607
ACUTE ORAL TOXICITY
(CONTINUED)
SUMMARY
Test Animal: Albino Rats - Sprague-Daw1ey strain Source: Harlan Sprague-Daw1e y , Madison UI 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 LD5 0 : 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 Leve 1 (q/ k o )
5.00
Hours 0-4 MF 00
1 MF 00
2 MF 00
Days 34 MF MF 00 00
5 MF 00
6 MF 00
7-14 MF 00
Tota 1 M F Bo th 0/5 0/5 0/10
Average Body Weights (g)
Initial
Day 7 Terminal
Ma 1e 221 276 295
Fe m a 1e
210
226 231
PATHOLOGY
An ima 1 Number C21437 C21439 C21434 C21433 C21432
Test Day Sex Died Sacr if iced
M - 14 M - 14 M - 14 M - 14 M 14
C21521
F
-
14
C21503
F
-
14
C21522
F
-
14
C21523
F
-
14
C21524
F
-
14
Necropsy Comments
No Uisible Lesions.
No Uisible Lesions.
No Uisible Lesions.
No Uisible Lesions.
Lungs - multiple, raised, grey f
on all lobes, pinpoint to 2 mm i
d iameter.
No Uisible Lesions.
No Uisible Lesions.
No Uisible Lesions.
No Uisible Lesions.
No Uisible Lesions.
0000V6
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).
GROSS CLINICAL OBSERVATIONS
Study Tittle: f l f 'i j J - * A / 'O J / O A i f l i J - L j
----
Testt Article: 1~~ 3A>/0"J
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Dosage Level: Q-C)C^ j0j~
Vehicle:
AJA .
------
Species:
f i n k ________ _____________
Dose Time: _ _ _________ ^ r * 3 o
-------------------
S#xs ---- ------------- -----
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GROSS CLINICAL OBSERVATIONS
study T itle:
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Test Article: Dosage Level:
T ' ________________ K No. .fljflZ j ) . b 9-/ ^ _____ Vehicle: ____ &L_____________
Species: ___ ___________________________ Dose Tine:
Sex: __ _____ _
000078
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Test Material
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ACUTE ORAL TOXICITY (LD5Q) RECORD
_________________ Vehicle AJA___________________ RT No .
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Bulk D e n s i t y --- (g/ml) Species fgjt
Source t-h? ______ Date Received_Z^ZilSL
Dosage
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Time 3 36piTech.
Room No. 3
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Dose Volume 3-76?(ml/kg)
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0-ltO \Actual Dose (ml )
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ft.h D-ltO
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BEST COPY AVAILABLE
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Dosage
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Dose Volume
(ol/kg)
Dose Time // '*20 ______ Tech. Date Scale Used:
Animal No./Ear Tag No.AZ
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MORTALITY (NO. DIED/NO. DOSED)
2 6Dose
Level
Hours 0 -4
1
Study Day ___________________________________________
34 5
7 8 9 1 D il 12 13 14 Total
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