Document aBZ87Bd9OyLE2QQynvgXg0pXe
WAAZLCMCN
3301 KINSMAN BLVD.
LQX3WUURIeS IANTERICA. INC.
. Chemical& BioMedicaSlciencesDivision
P.O.BOX 7645 MADISON, WISCONSIN 53707 PHONE (608)241-4471 TLX 703956HAZAAL Mi,),UsD
FINAL REPORT
JANINE GLEASON MINNESOTA MINING & MANUFACTURING TOXICOLOGY SERVICES ST. PAUL, MN 55101
COMPANY
T-3752 PURCHASE ORDER NUMBER: T357842, REL. 4513
L4 s
NUMBER:
SAMPLE ENTERED:
REPORT PRINTED:
50503499 05/15/85 02/12/85
ENCLOSED:
ACUTE ORAL TOXICITY CAU REPORT RAW DATA APPENDIX
- METHOD,
SUMMARY,
PATHOLOGY
SIGNED:
STEVEN M. GLAZA STUDY DIRECTOR ACUTE TOXICOLOGY
DATE
BY AND FOR HAZLETON LABORATORIES AMERICA, INC.
RAW DATA FOR THIS STUDY ARE KEPT ON FILE AT HAZLETON .AMERICA, INC., MADISON, WISCONSIN.
LABORATORIES
IWIFHIAAZILC%CN
LAEK3RMr3Rir=S ATAERICA. IN=
Chemical& BioMedicaSlciencesDivision
3301KINSMAN BLVD. a P.O.soX 7545 , #AADISON,WISCONSIN 53707 - PHONE (608)241-4471- TLX 703956HAZRAL MDS UD
SAMPLE NUMBER: 50503499 T-3752
PAGE
2
OECD ORAL SCREEN
Obiective: To determine the acute oral toxicity produced when a test material is administered bv oral gavaae to rat5 according to the Organi5ation of Economic C@operation ;nd Development'5 Guidelines for Testina Chemicals, Section 401, Acute Oral Toxicity, adopted May 12, 1981.
Test Material: T-3752 Phvsical Description:
Brown
St@bilit%j of Test Material:
granular solid Sponsor has purity and stability determinations on file.
Test Animal: Youna adult male and female albino rats of the SpragueDawleV strain we;e procured, maintained in group cages in temperatureand 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 bV 5eX in groups of five and identified by animal number and correspon@ina ear tao. Food and water were available ad libitum throughout the siudy, except for an overnight per'iod just before test material administration when food, but not water, was withheld.
Reason for Species Selection: The rat is the animal classically used due to its small 5ize., ready availability, and 16roe amount of background data.
,Method: Five male and five female rats weighing between 195 and 234 g were used for each dosage level. The study consisted of three dosage levels (0.20, 2iO and 5.0 g/ka).
Preparation and Administration of Test Material: For each dose level, the appropriate amount of test material was mixed with corn oil and heated and stirred on a stir plate to a uniform suspension. The suspension Wa5 cooled to room temperature prior to dosina. An individual dose was calculated for each animal based upon its fasted body weight and administered by gavage. The d05e Volume Wa5 15.0 tnl/kg of body weight.
Observations: The animals were observed for clinical signs and mortality at lp 2.5 and 4 hours followina test material administration. The animals were observed dailv th;reafter for 14 days for clinical sions and twice dailvI for mortalltvI.
All animals were weiched just before test material administration: at 7 days and at study termination or at death.
Patholoa,j:@ At 5tUdkJ termination surviving animals were euthanatized. Animai-s which died durino the study or were euthanatized received a aross necroos%j examinaiion and all abnormalities were recorded.
')HAZLOZON
L&BOR4=MIES
APAE-RICA, INC.
Chemical& BloMedicalSciencesDivision
3301 KINSMAN BLVD. o P.O.BOX 7645 * MADISON, WISCONSIN 53707 9 PHONE (608)241-4471 TLX 70!."ilH)A5Z6RAL MDS UD
SAMPLE NUMBER: 50503499 T-3752
PAGE
3
OECD ORAL SCREEN
SUMMARY
(CONTINUED)
Test Animal: Albino Rat5 - Sprague-Dawley strain Source: Harlan Sprague-Dawley, Madison Wl Date Animals Received: 05/22/85
Temperature and Humidity of Animal Room:
19 to 24 Decrees C.; 42 to 60% Relative Humidity
Vehicle: Corn-oil Method of Administration:
Oral Gavaae
Date Test Started: 05/30/85
Date Test Completed: 06/20/85
Estimated Oral LD50*:
Male - Between 0.20,and 2.0 a/kg of body weight Female - Between 0.20 and 2.0 9/kg of body weicht
Mortality Summary (Number of Deaths)
Dorzaae Levef (g/ka)
0.20 2.00 5.00
Hours
Days
0-4
1
2
3
4
5
6
m F* M F M F M F M F M F M F
0 0 00 0 0 0 0 00 a0 00 0 0 4 5 1 - - - -0 0 45 1
7-14 MF
0 .0
Total m F Both
0/5 0/5 0/10 5/5 5/5 10/10
5/5 10/10
Dosage Level (g/kg)
Male
0.20 2.00 5.00
Female
0.20 2.00 5.00
Averaae initial
224 212 196
201 215 211
Body Weights (a) Day 7 Terminal
263 ---
---
294 ---
---
209 -----
219 -----
HAZLMMON
L"Bcxqx%3miAte4EBMIrA. INC.
Chemical& B[oMedicaSlciencesDivision
3301KINSMAN BLVD. 0 p.o.BOX 7545 - MADISON, WISCONSIN 63707 PHONE (608)241-4471o TLX 703956HAZRAL MDS UD
SAMPLE NUMBER: 50503499 T-3752
PAGE
4
OECD ORAL SCREEN
(CONTINUED)
Clinical Sions
Hours
Dav5
1.0 2.5 4.0 . 1 2 3 4 5 6
89
Dosaae Level - 0.20 9/kg
Males
Appeared normal 4
3
2
0 0 0 455 55 5
HQooactivitQ
0
0
2
555 00 000 0
D i1 @rrhea
1
2
2
5 10 a00 00 a
Yellow-stained
abdomen
a
0
0
442 0 0 00 0 0
Red-stained face 0
0
0
551 000 0aa
Famale.t
Appeared normal 4
3
4
000455 555
Hy poactivity
0
0
a
3550 0000 0
Diarrhea
1
2
1
400 00000 0
Yellow-stained
abdomen
0
0
0
033 10 0 0 0 0
Red-stained face 0
0
0
22 00 00000
10 11 12
5 55 00 0 0 00 00 0 00a
555 000 00 0 00 0 00a
13 14
55 00 00 00 00
55 00 00 00 00
Do5aan Level - 2.00 g/kg
Appeared normal '5
1
0
Diarrhea
0
1
1
Hvpoactivity
0
4
5
R;d-stained face 0
0
0
Yellow-stained
anal area Ataxia Bradvpnea Death
0
0
0
0
0
0
0
0
0
0
0
0
Appeared normal 5
3
0
Hypoactivity
0
2
5
Diarrhea
0
1
4
Red-stained face 0
0
0
Prostration
0
a
0
BradtiDnea
0
0
0
Red-5tained
anal area
0
0
0
Death
0
0
0
Males 0 0 ------- - - - - 0 0 ------- - - - - 1 a ------- - - - - 1 0 ------- - - - - -
1 0 ------- - - - - 1 0 ------- - - - - 1 0 ------- - - - - 4 1 ------- - - - - -
Female5 0 -------- - - - - 1 -- -- -- -- - - - - 0 -------- - - - - 1 -------- - - - - 1 -------- - - - - 1 -- -- -- -- - - - - -
1 -------- - - - - 5 -------- - - - - -
HAZLOMON
LAEOMP.4OX3RIr=S At.IERIC.A.INC.
Chemical& BioMedicaSlciencesDivision
3301KINSMAN BLVD. o P.O.BOX 7545o MADISON,WISCONSIN 53707o PHONE (60&2t41-447e1 TLX703956HAZRAL MDS UD
SAMPLE T-3752
NUMBER:
50503499
PAGE
5
OECD ORAL SCREEN
(CONTINUED)
Clinical Sions (continued)
Hours 1.0 2.5
4.0
Dav5
12 3 4 5 6
8 9 10 11 12 13 14
Dosaae Level - 5.00 g/kg
Males
Appeared normal 5
4
0
0 0 -- ----- -
-
-
-
-
Diarrhea
0
1
1
1 0 - - - - -- - -
-
-
-
-
Hypoactivity
0
0
4
1 0 - - -- - - - -
-
-
-
-
Red-stained face 0
0
0
1 0 - ----- - -
-
-
-
-
Dark-stained uroaenital
area
0
0
0
1 0 - -- - - - - -
-
-
-
-
-
Death
0
0
0
4 1 - - -- - - - - -
-
-
--
Females
Appeared normal 3
3
0
0 -- ----- -
-
-
-
-
-
Diarrhea
2
2
2
0 -- ----- - -
-
-
-
-
Hvooactivitv
0
0
5
0 - - - -- - - - -
-
-
-
-
D;@th
0
0
0
5 --- ----- -
-
-
-
-
HAZLC%ON
Lai"z.=CX:IiEB AKAERICA. INC.
3301 @,'INSMANBLVD. 0 P.O.BOX 7645 * MADISON, WISCONSIN 53707
Chemical& B!oMedicalSciencesDivision
PHONE (6082)41-4471o TLX 703956 HAZRAL MDS UD
SAMPLE NUMBER: 50503499 T-3752
PAGE
6
OECD ORAL SCREEN
Dosage Level:
Animal
Number
Sex
C34524
m
C34518
m
C34504
m
C34510
m
C34509
m
C34465
F
C34499
F
C34466
F
C34464
F
C34473
F
(CONTINUED)
PATHOLOGY
0.20 g/kg of body weight
Date Dosed:
06/06/85
Test Day Died Sacrificed
-
14
-
14
-
14
Necrop5y
Comments
No visible lesions.
No visible lesions.
No visible lesions.
-
14
-
14
-
14
-
14
-
14
-
14
No visible No visible No visible No visible No visible No visible
lesions. lesions. lesions. lesions. lesions. lesions.
-
14
Liver - hepatic anomaly at junction of median lobes, 8 x 5 mm, liver-like.
HAZLETON
LABCX*Aa'CRIES AAAERICA, lt'JC.
Chemical& BlaMedicalSciencesDivision
3301 KINSMAN BLVD. o P.O.BOX 7545 9 MADISON, WISCONSIN 537(-,-"PHONE (608)241-4471a TLX 703956HAZRAL MDS UD
SAMPLE NUMBER: 50503499 T-3752
PAGE
7
OECD ORAL SCREEN
Doseae Level:
Animal
Number
Sex
C34483
m
C34480
m
C34481
m
C34477
m
C34512
m
C34493
F
C34463
F
C34485
F
C34469
F
C34492
F
(CONTINUED)
PATHOLOGY (continued) 2.00 g/kg of body weight
Date Dosed: 06/04/85
Test Day Died Sacrificed
Necropsy Comments
1
Red parinasal discharge; dark red,
bilateral periocular discharge;
parineum - moist, 5tained clear
-Yellow,
1
Red perinasal discharge; perineum -
moist, I stained clear yellow; eye - white intraocular material.
1
Red perinasal discharge; dark red,
bilateral periocular discharge;
perineum - 5tained clear yellow.
1
Red perina5al discharge; perineum -
moist, stained clear yellow;
2
Red perina5al dischaurge; perineum -
moist with clear fl id; bilateral
red ocular discharge; jejunum and
ileum - contain dark brown m'aterial.
1
-
I
-
1
-
1
-
1
-
Perineum
5tained yellow; small
intestine contains tan to yellow
mucoid material.
Perineum
stained yellow; small
intestine contains tan to yellow
mucoid material.
Perineum - stained yellow; jejunum contains dark brown mucoid material.
Perinsum
stained yellow.; small
intestine contains tan to.yellow
mucoid material.
Perineum
5tained yellow; small
intestine
contains tan to -,@ellow
muccid material.
IFIH"ALZLOZON
LAeK3FUUZX41ES ANERICA. INC.
Chemical& B!oMedicaSlciencesDivision
3301 KINSMAN BLVD. 0 P.O.BOX 7645 o MADISON, WISCONSIN 53707 9 PHONE (608)241-4471o TLX 703956HAZRAL MDS UD
SAMPLE NUMBER: 50503499 T-3752
PAGE
a
OECD ORAL SCREEN
Dosaae Level:
Animal
Number
Sex
C34505
m
C34479
m
C34513
m
C34503
m
C34507
m
C34500
F
C34495
F
C34484
F
C34498
F
C34467
F
(CONTINUED)
PATHOLOGY (continued) 5.00 g/kg of body weight
Date Dosed: 05/29/85
Test Day Died Sacrificed
3
2 2
2
-
2
-
2
-
2
-
2
-
Necropsy Comments
Stomach - contains dark brown semisolid material.
No visible lesions.
Stomach - contains dark brown semisolid material.
Stomach-- multiple areas on glandular 2 x 3 mm.
dark brown mucose, up to
No visible lesions.
No visible lesions.
No visible lesions.
Upper thoracic cavity contains dark red, clotted material.
2
-
2
-
No visible lesions. No visible- lesions.
Deviation from the protocol: During the studv period the temperature of the animal room ranoed from 19 to 24 dearee; C. This deviation is not considered to have @ad an effect on the-validity of the study.
References: Orcanisation for Economic Cooperation and DevelODment's Guidelines fo; Testing of Chemicals., Section 401, Acute Ora'l Toxicity... adopted May 12, 1981.
QUALITY ASSURANCE STATEMENT Acute Oral Toxicity Study in Rats
Study No. 50503499
The report as herein attached for the above-mentioned study has been reviewed by the assigned Quality Assurance Unit of Hazleton-Laboratories America, Inc. It has been found to accurately identify and/or describe the authorized methods and standard operating procedures followed in the conduct of the study. Purthermore,*the Quality Assurance Unit has conducted the following inspections of the testing facilities utilized in the conduct of this study and has submitted written reports of said inspections to the study director and/or.management.
Date of Inspection 5/21-23/85 7/12/85
Type of Inspection Process Audit Report Review
Date Issued to Management 5/23/85 7/12/85
Diana E. Skalitzky Inspector, Quality Assurance Unit
Date
'feetMaterial Wk Density
T-3,7Q!s
AIR
(9/121)
0
ACUTE ORAL TOXICITY (LD50 ) RECORD
Vehl 1 -CQIZO oli--
RT
SPOclOs Famteds
D#te
Source UgLr leh to-S-15 Ti.@@'-
Date Bece -c&. I-IM(- Ro
Done Volume
/kit)
Dose Tim 1 0&0)
Sax Anisai -No./Bar Tag W.r-s qSaq qSD I Iq
10
qqla
q
Tecia,
a
Fasted Body Welailt (g) Actual Dose (al Day 7 Bo y weight (a) DEaPya4 14 5-odyWeight (a)
557 Ioq2
)7 ao
o
3.
-3.5-3-4
13.-6 3.3
Q9.1 see ftr_i led bv
Dosage
0. 30 (R/ka)
Dose Volume )il,O-(Ml/k&)
AnAPVAinl0,cRir8a0tmm,o'auaet*lateeVladostN0"IDeo4W.o/got T!@g N-p. 4
Dose qqqi__lq4(d, q4la4_ q475
q@ 44'71 4,4A99
Tects. ow &
Pretanted Body Weigist
Fasted Body Weigi(lRt)
Actual Done
.20 -oo
3,o 3.0 Z.15 3.C, 3.0
Day 7 BodY WeiRlit (R)
14
a
Day 14 Body WeiRlit (g)
ZZO 211 210 Z13 Z-365
VA
gas V rifi&'d hv
Done
liours 04
a QA 144 Ti
Date ills "A - not Applicable
MORTALITY (NO. DIED/NO. DOSZD)
1
2
3
4
5
6
7
8
no n
Ikostnot modmintatered
Reviewed
-
9
10-- 11
no
C'16 D
C)
0
fiex
Test Material -T--2j'75Q
ACUTE ORAL TOXICITY (LD ) RECORD 50
Vehicle
Wk Density 6!A
(g/mi)
Species Pastedt
Dpte
Source Time 3.'00
Date Tech. f-IZ
d-C)
a)
Dose-Vol~
tsounlikg)
Animl No.IVAr T&R no a
qqch'3 q
Protasted 5-ody V
--
Fasted Body Weialit (g)
00
Actual Does (mi
3.0 5, X
(it)- Day I l@od Weight (g) "Itro
'I
a
DMCI
Dav 14 body Weight
6Mf-
Dose Tim
3.0 -3.a
PgA
Li.5'1. .,rf@
977 a.,@1.2
Tech.
1
fy9
3.a '1.'5 U&IIP
1 9 111 ck
0.5-154ii;@, 3A
DoW@ Ve-ritted byl
RT
Becel
Roo tqf5 Date
Doan"
(g/kg)
Dose VolunO 15-D (mliks)
Animal LO./gar Tag
Pretasted Body WelList
Fasted bodl Weight it) .70
ArActual Done pi
3.1
pre D"Dacaa't 7 Body Weight (g)
-
Day
Day 14 Body Weight (a) 11%9
-
:205' 20& ;21 3.1 13.1
it.oo
Teel%. Dot
3.;l sto man VaKLLLed-hil IV9 16,
MORTALITY (NO. DILPD/NO. DOSED)
Dogia Level
liours 04
2- -3
4
sit
6
7
8
10
11
?.0 --.
c2.L)
Technician
[4
Li
Date
NA - Not.Applicable
6
st----- -olo-sinto,ble-ernot administered
Reviewed by
ACUTE ORAL TOXICITY 4LO50 RECORD
Test material-T-
Vehicle eof-fd -oil-
RT
Bulk Density @J 19 48/al) species
source.--%kaelon -
Date Recol
C) Dosage
Done Volume ISO 4t
Fastedi DiptoS-;M-SS Time -3:le_WTeck. -i*M Roo
-Dose Time 1-1 C&L.
Tech.
ai
Sax Animal Roo/Eat TaR
44-11 40-1"5 4523
1;at
Pretasied Body Weight (&I lAq
- ---
FB8tC4 body WSLRI%T (g)
11
195 q
Actual Done 401 Day 7 Body Weight (g) Day 14-Pody Welaht
13.0 1 ati
1 F,6CLa
a
-i-IScf ipi
wwn L@-j/-I
/,0.751915
'753
C1*65 pass@ Ve-ri
Dosage'
S.0 (g/kkit) (alC/5kg)
Done Volume 15,o (al/kg)
Animal.-Ho./zar T-a m 5 qsoo dql,q4i5 q q
so
4
4495
Teel&.
PretastedBody W*ILIit(g) A
Y- Fasted body Weigist(R) Actual Dogto Day 7 Body WeiRlit (R)
12C)b
.3.%
-S-3- 3-aL 3.4
pt-,-UT-ia7-
Pit
cr
'3,5
Day 14 Body Welatit(a)
giab 1945 lqq!5 a))@
Verifiedhvl-
is.
MORTALITY (00. DIED/NO. DOSED)
Dose
Iloure
Level 0 - 4 1 2 3
[0 r.1;
am n u ri
-
4 -5
st Dav 6- 7
IUL UL
t
10 11
TecionV-an
r-OCKA
NA - Not Applicable
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calculated. but not administered
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HAZLF;'C(ONLABORATORIES
3301 KINSMAN BLVD.
P.O. BOX 7545
AMERICA, INC.
MADISON, Wl 53707 (608)241-4471
TLX 703956 H.AZ.RA.L,,MDSUD
PROTOCOL TP2069
Acute Oral Toxicity Study in Rats (OECD Guidelines)
Study No. 50503499
for
3M St. Paul, Minnesota
by
Hazleton Laboratories America,
Life Sciences Division
3301 Kinsman Boulevard
Madison, Wisconsin
53704
Inc.
May 21, 1985 1985, Hazleton Laboratories America, Inc.
Chemical & BioMedical Sciences Division
PROTOCOL TP2069
Acute Oral Toxicity Study in Rats (OECD Guidelines)
Study No.: Study Location:
Test Material: Sponsor's Representative: Study Director: Proposed Timetable
Starting Date: Completion Date: Final Report Date:
50503499
Hazleton Laboratories America, Life Sciences Division 3301 Kinsman Boulevard Madison, Wisconsin' 53704
Inc.
T-3752
Janine Gleason
Steven M. Glaza
Week Week Week
of May 27, 1985 of June 17, 1985 of July 15, 1985
OBJECTIVES
To determine the acute oral toxicity produced when the test material is
administered by the oral route (gavage) to rats. All aspects of this study
will conform to the Organisation for Economic Cooperation and Development's
Guidelines
for Testing
of Chemicals,
Section 401,
adopted
May
1 12, 1981
and
2 Principles of Good Laboratory Practice. All procedures will be done
according to Hazleton Laboratories America, Inc. (HLA) Standard Operating
Procedures (SOPS) referenced in th.isprotocol.
Test Material: Physical Description: Purity and Stability: Storage Conditions: Test Material Retention:
Safety Precautions:
TEST MATERIAL
T-3752.
Brown granular solid.
Sponsor has purity and stability determinations on file.
Store at room temperature.
Any unused test material will be returned to the Sponsor 30 days after issuance of the final report.
Laboratory personnel will take the normal necessary precautions in handling a substance of unknown toxicity. Laboratory clothing, latex gloves, safety glasses, and a particle mask approved for toxic dusts must be worn.
2
TEST SYSTEM Animal Model
Young adult male and female albino rats (approximately 7 weeks of age) of the Sprague-Dawley strain will be obtainea-@rom Harlan Sprague-Dawley, Madison, Wisconsin. Rats will be selected at random from healthy.animals that had been acclimated at HLA for at least 1 week. An adequate.number of extras will be purchased in order that no animal in obviously poor health is placed on test. The weight variation in animals used on test will not exceed +20% of ,the mean weight (i.e., mean - 250 g, range 200 to 300 g).
Reason for Species Selection The rat is the animal classically used due to its small size, ready
availability, and large amount of background.data.
Identification Each animal will be assigned an individual animal number and ear tag which
will accompany data collected from that animal throughout the study (OP-GENB 24).
Housing_ and Maintenance
The following environmental conditions will be maintained in the animal
room used for this study (OP-TARC 230).
0
Temperature: 22*C +20
Relative humidity: 50% +20% Air change: At least 107changes an hour of filtered 100% outside air Light cycle: 12 hours light/12 hours dark
Temperature and humidity will be monitored throughout the study. Variations
from prescribed environmental conditions will be documented.
3
Animal husbandry and housing at HLA comply with standards outlined in the 3
"Guide for the Care and Use of Laboratory Animals." Care will be taken to ensure that the animals are not disturbed for reasons other than data collection and routine maintenance. The animals will be individually housed in screert-bottomstainless steel cages held on racks, with absorbent pan liners in the urine- and feces-collecting pans. Pan liners will be changed at least three times each week.
Feed and water will be provided ad libitum. The diet will be Purina Rat Chow"0. No contaminants are expected to be present in the feed or water which would interfere and affect the results of the study.
PROCEDURES Experimental Design
Initially, a single dose of 5.0 g/kg will be administered to 10 animals (five males and five females). If no test material-related mortality is produced at this level, no further testing is required. If any mortality occurs at the 5.0-g/kg dose level, at the Sponsor's request, three or four geometrically spaced dose levels may be added. Each dose level will consist of 10 animals (five males and five females). Animals will be assigned to groups according to HLA Standard Operating Procedure OP-TOX 42.
Test Material Preparation and Administration The test material will be suspended in an appropriate vehicle. Individual
dosages will be calculated based upon the animal's body weight taken just before administration of the test material and administered by gavage.
4
Justification of Route of Administration This is the method for administering a known quantity of test substance
and has been the route of choice historically.
Observations The animals will be observed individually for clinical signs and mortality
at 1.0, 2.5, and 4 hours after test material administration. The animals will be observed daily thereafter for at least 14 days for clinical signs and twice daily (morning and afternoon) for mortality. The duration of observations may be extended when considered necessary. The time of death will be recorded as precisely as possible.
Individual body weights will be recorded just prior to study initiation and at 7 and 14 days following test material.administration and at death. Changes in body weight will be calculated and recorded when survival exceeds 1 day.
Pathology All test animals, whetber dying during the study or sacrificed at'
termination, will be subjected to a gross necropsy examination and abnormalities recorded.
Report The final report will contain a description of the test material, a'
-description of how the study was conducted, response data for clinical signs, mortality and body weights by sex, a discussion of the data, and gross pathology findings.
5
Maintenance of Raw Data and Records Original data or copies thereofwill be available at HLA to facilitate
auditing the study during its progress and prior to acceptance of the final report. When the final report is completed,all original paper data, as well as the final report, will be retained in the archives of HLA, Madison, Wisconsin (OP-GEN 44).
REFERENCES 1. Organisation for Economic Cooperation and Development's Guidelines for
Testing of Chemicals, Section 401, Acute Oral Toxicity, adopted May 21, 1981. 2. Organisation for Economic Cooperation and Development's Principles for Good Laboratory Practive, Annex 2, 1981. 3. DHEW Publications No. (NIH) 78-23 (1978).
6 PROTOCOL APPROVAL
o./IIt)
a innseeorG.llseeason J@a nlnsorts Representative 3M
jr-laq-1@!cj-
Date
Steven M. Glaza
0
Study Director
Group Leader, Acute Toxicology
Hazleton Laboratories America, Inc.
(1107S/tji)
Date