Document 8RXa0E4QG0wqaRRqJGmr5OEe
Attachments to Letter to C. Auer dated May 18,2000 Studies and Other Information on Certain
Perfluorooctane Sulfonate-Related Compounds
/ | R 2 r 0 2 L| 3 -
7. N-MeFOSA N-methyl perfluorooctanesulfonamide
Acute Toxicity
1) Acute Oral Toxicity - Method, Summary, Pathology QAU Report, Hazleton Laboratories America, Inc., Project No. 50503499, 3M Reference No. T-3752 (F7075-4, water-washed, acid washed), July 12, 1985, with Protocol
2) Primary Dermal Irritation - Method, Summary, Pathology QAU Report, Hazleton Laboratories America, Inc., Project No. 50503500, 3M Reference No. T-3752 (F7075-4, water-washed, acid washed), June 24, 1985, with Protocol
3) Primary Eye Irritation - Method, Summary, Pathology QAU Report, Hazleton Laboratories America, Inc., Project No. 50503501, 3M Reference No. T-3752 (F7075-4, water-washed, acid washed), June 24, 1985, with Protocol
4) Acute Oral Toxicity - Method, Summary, Pathology; Primary Dermal Irritation Method, Summary; Primary Eye Irritation - Method, Summary; QAU Report; Raw Data Appendix, Hazleton Laboratories America, Inc,. Project No. 50202473, 3M Reference No. T-3727 (F-10034, Lot 7, distilled wide-range), May 7, 1985, with Protocol
5) Acute Oral Toxicity Screen with T-3065CoC in Albino Rats, Riker Laboratories, Inc., Experiment No. 0981AR0145, May 15, 1981
Genotoxicitv
1) In Vitro Microbiological Mutagenicity Assays of T-3752, SRI International, Project No. LSC-3145, 3M Reference No. T-3752 (F-7075-4, water-washed, acid washed), June, 1985
2) In Vitro Microbiological Mutagenicity Assays of T-3727, SRI International, Project No. LSC-3145, 3M Reference No. T-3727 (F-10034, Lot 7, distilled wide-range), March, 1985
- 12-
001010
H A ZLETO N
laboratories America.iNc.
Chemical & BioMedical Sciences Division
3301 KINSMAN BLVD. P.O. BOX 7545 MADISON, WISCONSIN 53707 PHONE (608) 241-4471 TLX 703956 HAZRAL M DS UD
FINAL REPORT
JANINE GLEASON MINNESOTA MINING & MANUFACTURING COMPANY TOXICOLOGY SERUICES ST. PAUL, MN 55101
T-3752 PURCHASE ORDER NUMBER: T357842, REL. #513
* -J.UL 15 1385
v-S< c `Vcov',,
S*STri NUMBER: 50503499 SAMPLE ENTERED: 05/15/85 REPORT PRINTED: 07/12/85
ENCLOSED:
ACUTE ORAL TOXICITY - METHOD, SUMMARY, PATHOLOGY OAU REPORT RAW DATA APPENDIX
SIGNED
STEUEN M. GLAZA STUDY DIRECTOR ACUTE TOXICOLOGY
O
.............. DATE
BY AND FOR HAZLETON LABORATORIES AMERICA, INC.
RAD DATA FOR THIS STUDY ARE KEPT ON FILE AT HAZLETON LABORATORIES AMERICA, INC., MADISON, WISCONSIN.
GOiOll
@ H A Z L E T O N LABORATORIES AMERICA. INC.
Chemical & BioMedical Sciences Division
3301 KINSMAN BLVD. P.O. BOX 7545 MADISON, W ISCONSIN 53707 P H O N E ^
SAMPLE NUMBER: 50503499 T-3752
PAGE 2
OECD ORAL SCREEN
Objective: To determine the acute oral toxicity produced when a test material is administered by oral gavage to rats according to the Organisation of Economic Cooperation and Development's Guidelines for Testing Chemicals, Section 401, Acute Oral Toxicity, adopted May 12, 1981.
Test Material: T-3752 Physical Description: Brown granular solid Stability of Test Material: Sponsor has purity and stability determinations on file.
Test Animal: Young adult male and female albino rats of the SpragueDawley strain were 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 by sex in groups of five and identified by animal number and cor respond ing ear tag. Food and water were available aji 1ib iturn throughout the study, except for an overnight period 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 size, ready availability, and large 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, 2^0 and 5.0 g/kg).
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 was cooled to room temperature prior to dosing. An individual dose was calculated for each animal based upon its fasted body weight and admin istered by gavage. The dose volume was 15.0 ml/kg of body weight.
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 or at death.
Patho logy: At study termination surviving animals were euthanatized, Animals which died during the study or were euthanatized received a gross necropsy examination and all abnormalities were recori^ecy
H A Z L E T O N laboratories America,Inc
Chemical & BioMedical Sciences Division
3301 KINSMAN BLVD. P.O. BOX 7545 MADISON, WISCONSIN 53707 PH O N E (608) 241-4471 TLX 703956 HA2RAL MDS UD
SAMPLE NUMBER; 50503499 T-3752
PAGE 3
OECD ORAL SCREEN
(CONTINUED)
SUMMARY
Test Animal; Albino Rats - Sprague-Dawley strain Source: Harlan Sd rague-Daw1e y } Madison UI Date Animals Received: 05/22/85
Temperature and Humidity of Animal Room: 19 to 24 Degrees C. 42 to 60? Relative Humidity
Uehicle: Corn oil Method of Administration: Oral Gavage
Date Test Started: 05/30/85
Date Test Completed: 06/20/85
Estimated Oral LD50*: Male - Between 0.20 and 2.0 g/kg of body weight Female - Between 0.20 and 2.0 g/kg of body weight
Mortality Summary (Number of Deaths)
Dosage Leve 1 (g/kg)
0.20 2.00 5.00
Hours
Davs
0-4
1 2 3 '4
M F' M F M F MF MF
56 MF MF
0 0 00 00 00 00 00 00 0 0 45 10 0 45 1-
7--14 MF
00
--
Total M F Both
0/5 0/5 0/10 5/5 5/5 10/10 5/5 5/5 10/10
Dosage Level (g/kg)
Male
0.20 2.00 5.00
Female
0.20 2.00 5.00
Average Body Weights (g)
Initial
Day 7 Termina 1
224 212 196
263
--
--
294
--
--
201 215 211
209
-- --
219
-- --
001013
& HAZLETON LABORATORIES AMERICA. INC.
Chemical & BioMedical Sciences Division
3301 KINSMAN BLVD. P.O. BOX 7545 MADISON, WISCONSIN 53707 PHONE (608) 241-4471 TLX 703956 HAZRAL MDS UD
SAMPLE NUMBER: 50503499 T-3752
PAGE 4
OECD ORAL SCREEN
(CONTINUED)
Clinical Signs
Hours 1.0 2.5 4. 0
Days 1 2 3 4 5 6 7 8 9 10 11 12 13 14
Dosaae Level - 0 .20 g/kg
Males
Appeared normal 4 3 2 0 0 0 4 5 5 5 5 5 5 5 5 5 5
Hypoact ivi ty
0 0 2 555 000000 0 0 0 0 0
Diarrhea
1 2 2 510000000 0 0 0 0 0
Ye 1low-sta ined
abdomen
0 0 0 442 Q00000 0 0 0 0 0
Red-stained face 0 0 0 5 5 1 0 0 0 0 0 0 0 0 0 0 0
Females
Appeared normal 4 3 4 0 0 0 4 5 5 5 5 5 5 5 5 5 5
Hypoact ivi ty
0 0 0 355 000000 0 0 0 0 0
Diarrhea
1 2 1 4 00000000 0 0 0 0 0
Ye 1low-sta ined
abdomen
0 0 0 03 3 100000 0 0 0 0 0
Red-stained face 0 0 0 2 2 0 0 0 0 0 0 0 0 0 0 0 0
Dosaae Level - 2.00 g/kg
Appeared normal
Diarrhea
0
Hypoact ivi ty
0
Red-stained face Q
Yell ow-s ta ined
anal area
0
Ataxia
0
Bradypnea
0
Death
0
1 1 4 0
0 0 0 0
0 1 5 0
0 0 0 0
Appeared normal 5 3 0
Hypoact ivi ty
025
Di arrhea
014
Red-stained face 0 0 0
Prost rat ion
000
Bradypnea
000
Red-stained
anal area
000
Dea th
000
Males 00 00 10 10
10 10 10 41
F e m a 1es 010111-
15-
coiaio
HAZLETON
Chemical & BioMedical Sciences Division
3301 KINSMAN BLVO. P.O. BOX 7545 MADISON, WISCONSIN 53707 PH O N E (608) 241-4471 TLX 703956 HAZRAL MDS UD
SAMPLE NUMBER: 50503499 T-3752
PAGE 5
OECD ORAL SCREEN
(CONTINUED)
Clinical Signs (continued)
Hours 1.0 2.5 4.0
Days 1 2 3 4 5 6 7 0 9 10 11 12 13 14
Dosaoe Leve 1 - 5.00 g/kg
Ma 1es
Appeared normal 5 4 0 0 0
Diarrhea
0 1 1 10
Hypoact ivi ty
0 0 4 10
Red-stained face 0 0 0 1 0
Dark-stained urogen ita 1
area
0 0 0 10
Death
0 0 0 41
Females
Appeared normal 3 3 0 0 -
Dia rrhea
2 2 2 0-
Hypoact iv ity
0 0 5 0-
Death
0 0 0 5-
001015
H A Z L E T O N LABORATORIES AINRICA, INC.
Chemical & BioMedical Sciences Division
3301 KINSMAN BLVD. P.0. BOX 7545 MADISON, WISCONSIN 53707 PH O N E (608) 241-4471 TLX 703956 HAZRAL MDS UD
SAMPLE NUMBER: 50503499 T-3752
PAGE 6
OECD ORAL SCREEN
(CONTINUED)
PATHOLOGY
Dosage Le v e l: 0.20 g/kg of body weight
Date Dosed: 06/06/85
Animal Number
Test Day Sex Died Sacrif iced
Necropsy Comments
C34524
M
- 14
No visible les ions.
C34518
M
- 14
No visible 1es ions.
C34504
M
- 14
No visib le 1es io n s .
C34510
M
- 14
No visible lesions.
C34509
M
- 14
No visible lesions.
C34465
F
- 14
No visible lesions.
C34499
F
- 14
No visible lesions.
C34466
F
- 14
No visible 1es ions.
C34464
F
- 14
No visible les ions.
C34473
F
_ 14
Liver - hepatic anomaly at junction of median lobes, 8 x 5 mm, liver-like.
001016
( S H A Z L E T O N LABORATORIES AMERICA, INC.
Chemical & BioMedical Sciences Division
3301 KINSMAN BLVD. P.O .B O X 7545 MADISON, W ISCONSIN 53707 PH O N E (608) 241-4471 TLX 703956 HA2RAL MDS UD
SAMPLE NUMBER: 50503499 T-3752
PAGE ?
OECD ORAL SCREEN
(CONTINUED)
PATHOLOGY (continued)
Dosage Level: 2.00 g/kg of body weight
Date Dosed: 06/04/85
Animal Number
Test Day Sex Died Sacrificed
Necropsy Comments
C34483
M
1
Red perinasal discharge? dark red, bilateral periocular discharge; perineum - moist, stained clear yellow.
C34480
M
1--
Red perinasal discharge; perineum moist, stained clear yellow; eye - white intraocular material.
C34481
M
1
Red perinasal discharge; dark red, bilateral periocular discharge; perineum - stained clear yellow.
C34477
M
1
-
Red perinasal discharge; perineum moist, stained clear yellow;
C34512
M
2
Red perinasal discharge; perineum moist with clear fluid; bilateral red ocular discharge; jejunum and ileum - contain dark brown material.
C34493
F
1--
Perineum - stained yellow; small intestine - contains tan to yellow mucoid material.
C34463
F
1
Perineum - stained yellow; small intestine - contains tan to yellow mucoid material.
C34485
F
1"
Perineum - stained yellow; jejunum contains dark brown mucoid material.
C34469
F
1--
Perineum - stained yellow; small intestine - contains tan to yellow mucoid material.
C34492
F
1-
Perineum - stained yellow; small intestine - contains tan to yellow mucoid material.
001017
H A Z L E T O N LABORATORIES AMERICA, INC.
Chemical & BioMedical Sciences Division
3301 KINSMAN BLVD. P.O .B O X 7545 MADISON, WISCONSIN 53707 PHONE (608) 241-4471 TLX 703956 HAZRAL MDS UD
SAMPLE NUMBER: 50503499 T-3752
PAGE 8
OECD ORAL SCREEN
(CONTINUED)
PATHOLOGY (continued)
Dosage Level : 5.00 g/kg of body weight
Date Dosed: 05/29/85
Animal Number
C34505
Test Day Sex Died Sacrificed
M3
Necropsy Comments
Stomach - contains dark brown semisolid material.
C34479 C34513
M M
2 2
No visible lesions.
Stomach - contains dark brown semisolid material.
C34503
M
2
Stomach - multiple dark brown areas on glandular mucosa, up to 2 x 3 mm.
C34507 C34500 C34495 C34484
M F F F
2 2 2 2
No visible lesions.
No visible lesions.
No visible lesions.
Upper thoracic cavity contains dark red, clotted material.
C34498
F
2
-
C34467
F
2
No visible lesions. No visible lesions.
Deviation from the protocol: During the study period the temperature of the animal room ranged from 19 to 24 degrees C. This deviation is not considered to have had an effect on the validity of the study.
References: Organisation for Economic Cooperation and Development's Guidelines for Testing of Chemicals. Section 401, Acute Oral Toxicity, adopted May 12. 1981. 001018
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. Furthermore, 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 7
u
Inspector, Quality Assurance Unit
Date
001019
Oo
T ea t M a teriel T 375-3
iLa.Bulk D e n s ity .
(g /a l)
ACUTE ORAL TOXICITY (L U ^ ) RECORD
V e lile ! ___Cp*K > 'O IL .
S p e c i e s . J t e . Source. cioJX.
Date
Fastedi Pte_^;5:1?^ T lM d d illS liS > K 5ii. 0 M C
RT Mo. /TOSOSWI
Roosi N o.__ ^
Sex J
Dose Voluae 6 ( a l / k t ) ___________________ Pop* T in e / q . qq
A n iaal N o./E ar Tea I t o X 'i 45 M 45!
P r e ffu te ii Indy Ifela h t /mi AJh " P asted Body W eight ( i ) Z 3 t 3 5 7
Actual Dose (ad )
M
Day 7 Body W eight ( g )
M
Day 14 Body Weight ( a ) ___ <093
rror ic t - I S inn G) enrorii-fc K tSIF
% *
45o*J
aao 3 .3 3 .5
A tti Ali
S T L 3 iq
i
45>o
3-4 viol
\\\15M v=
3.3 3 3 2<*3
* _ a la Doses V e r ifie d bv
T ech. dale S c a le U sed:
4*7 (o~Le
NA
?'{ji--JAS--------------
frb h*n%.
iiTOO / S t f l l NA
to n b 1 3 K rm JlS'O iQ
dm*- /i*ac> itfron 3611 T r ^ f o ~ 0 ____ NA_________
Dosage
O . HO (g/kg)
Oose Volume is.O ( 1 /k g )
A nlual N o./E ar Taa No.CS
P r e fa s te d Body W eight ( g ) A/rt P asted Body Weight ( a ) 2 0 0
Actual Dose ( B| ) Day 7 Body Weight ( g ) Day 14 Body Weight (g ) '
l i 'O aia, ZL
4441
2oo
m 211
4V *
joO 3 .0 to 210
Does T in e I 0 `>i a .*.___________ T e c h . r iS fi S c a le U sedt
\\\\Jot
3 .0 Art 213
4 0 ^ 1M7I 444Y
0.5 J o a 3 .1
* 235 *
200 3 .o
*
\ V
w b-U
NA
Uw torn
io~U> b-f3
KT&*) /Stt/9
NA
R-recA/ S o i l
Olili- U -2 0 UT ROW I5019
ttoacg V e r if ie d .b x _____ c i L y-6 .. . . MA_________
MORTALITY (NO. DIED/NO. DOSED)
Doae
Hours
StlHlY PflY.-
la v a i
0 -4
10
aa.
% f rx L o a o J i u -
& isO.aOa k. f t
Technician w
ioF\>::
Date \\<fe (olio t
NA - Not A p p lic a b le
* _ U n -! o . i m l nr Mil. but n o t a d m in ister e d
%" t
f t Vh' A
it-
(Mof m &
Reviewed b y .
4 Total r a r a c n Pff
1A- n /t a'
m m IA r i 5
mm mr a m p a UL 4A U/^ la
0010
ooo
ACUTE ORAL TOXICITY (L D ^ ) RECORD
T eat M a te r ia l _ T ' 3 7 ^ _____________________ __ V e h lc l
CoftP Q .t.________________rt No. S O S P3t/9<?
Bulk P e n a lty ----- ------- ( g / a l ) S p e c ie s -- Rcvfr'___ Source & i x \ a v \ __________ D ate R eceived ,5 ^ 2 ? -% $ "
Dosage
Q - fe/kc) _
Faated 1 D ate, la - 3 - 1 < Thae 3 - 0 0 f/n T e c h . O * '
Ro o m No .
lQ$ S
~K
Doae Voluae / O t a l / k i )
Doae T ia e |C MS' a .rft.
Tech. Date S ca le Uaed:
A n lu l N o./E ar Tea N o . V
VV78 y v s c f / H i
w a f M i u i t *yi |Vo IAI
Faated Body W eight (g ) A ctual Doae (a d ) Day 7 Body W eight ( g ) Day M Body Weight ( a )
30$"
3.1
m paid
A-
QQO
3 ,0 3 ,\ Map H?S
* Dead At
oo3 3 ,0
# *
W 7 WS/2
a l l n>?? 1
3 .a 3 .0 Mad
o4(> U ln -W
Deftfta V e r if ie d bv
rP rP
fa r *1
.. /rid .
rV <tV fed
id
NA ------------------- > .
NA
'-- ------------MA
Doaage
2 ,0
(g /k g )
Doae Voluaw 5.0 ( u l/k g )
Doae Tlue <1OQ *.n\.
A nlaal N o./E ar Tag No. W?3 W7? VVMWAS h w W <w\
Tech. Date S ca le Uaed:
rP (sfa NA
>P refa a ted Body Weight (a ) n h
Faated Body Weialit (a ) o o f g o f 2O0> a;W ?*% Qt( 0QO
( )A ctual Doae !
Day 7 Body W eight (g )
Day U Body Weight (g )
3.1 3.1 S' m*** *
3.1
W
3,5 a\5rDr*lc*l ?
M j)
3QL
5H20&0w
3 iO *
toneVsrltleiLJhx
ry? % L . KT*9 / SO/9
dL NA
ftp Lc. __ NA____
MORTALITY (NO. DIED/NO. DOSED)
Doae le v e l
lloura
0 -k
r
11 2 1 3
<
Bn m m m m si m n
' ?n m
Studly Da y
n 1 ( 8 | 9 1 10 | 11 m m t i m n rn m m m m en m
I n . 1 i3 m m co m
I i a _ T o ta l
mm
3 .n
% - ft % Xr at-
HA 5 / 5
3 ,0
K g Mfc-
T e c h n ic ia n a CcbMal ) _ 11f1t): 1il iar* .mU.-
__
_ __
Pate
t*L
AL/
.ff. -- . 2 i k . i 8f
_ __
NA - Nut A p p lic a b le ---- -- *--*
a eJ^Inlokarad
__
_ _ __ _ __ _
__ _
__ __
Reviewed b y ______ pnt c
> HA r>/5
_ M TTV*
HA i*|e u
M-
-- TZtTTW
ooo
ACUTE ORAL TOXICITY (L U ^ ) RECORD
Teat M aterial
-------------------------- !-----------i V a M r l a
Qg-ivi ftiL .____________ RT Mo. 5 a 5 o 3 4 4 4
Bulk P en alty
( g / n l ) S p e c le a .- A * _ S o u r c e
Date Received 5 0 3 - 1 5 '
Doaage
5.0 f c /k s )
Doae V oluae 15.0 ( n l/k a )
F aatedt D ate_5-P 1-iiT T tae 3.0O^KT*ch. if*rr\ Rooa No. O
Doae T lae Il.W<Ta..*.
:T ech. Dae S c a le Uaed
HSDGTA n laal M o./Ear Taa N o.62
M471
43l3 qsa 34S07
*f5P 4504 V
A)i9- X I
Sam 5 >3 0
NA
------- *s
F asted Body W eight (r) )A ctual Doae ( a l
Day 7 Body W eight ( g )
Day 14?Body Welaht (r)
l1(- 147 1 |4<# 115
1</ \
3,1
nm 3170a
p4i.&0J
CA.
PaUt*.LvA PqUUl.P\
PAlA1.p
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S'3144 * Bgttg
JL_ Y*rMLedhy
<5-30 K-TEwO 1348
5*-30
NA
--S.-2Q__ NA____
Doaage
5 .0 (g/kg)
Doae V oluae 1 5 ,0 ( a l/ k g )
*I
Doae T la e latoo#.^._________'____
A n iaal N o ./E a r Taa Ho. 0 3 4 5 0 0 V4$5 44*4 44*S 44i7_ 44 5 \
P r e fa ste d Body Weight (g ) p f i
F asted Body WeiRht ( r )
3oZ US
DXO 7/0
1 * *?<>
\\ \
A ctual Doae ( ! ) Day 7 Body WeiRlit ( r)
ViSr3.1 3 .3 3 .3 3 .A 3 .-a 3 .5
Pemtl P M 1
ce CK
IK
ft
i
\
Day 14 Body Weight (g )
5-ii-is
*
poaea V erified hy
Tech. irrtrrt
So
U S cale Used:
<5^30
NA
5"'^0 KT^ori 348
5 -3 0
NA
......... HA_________
MORTALITY (NO. DIED/NO. DOSED)
Dose Level
Hours 0 -4
1
1 pnm
2
____________ Studly Pay________________________________________________
3
pm
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u
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1 34 SB Pff
Total
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H A Z L E T O N LABORATORIES AMERICA, INC.
3301 KINSMAN BLVD. P.O. BOX 7545 MADISON, Wl 53707 (608) 241-4471 TLX 703956 H A ?R A L MDS UD
PROTOCOL TP2069
Acute Oral Toxicity Study in Rats (OECD Guidelines)
Study No. 50503499
/ I MAY2 41S35
\ "V ^. 3
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for
3M St. Paul, Minnesota
by
Hazleton Laboratories America, Inc. Life Sciences Division 3301 Kinsman Boulevard
Madison, Wisconsin 53704
May 21, 1985 1985, Hazleton Laboratories America, Inc.
Chemical & BioMedical Sciences Division
001053
1
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, Inc. Life Sciences Division 3301 Kinsman Boulevard Madison, Wisconsin 53704
T-3752
Janine Gleason
Steven M. Glaza
Week of May 27, 1985 Week of June 17, 1985 Week of July 15, 1985
001054
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 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 this protocol.
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.
001055
2
TEST SYSTEM Animal Model
Young adult male and female albino rats (approximately 7 weeks of age) of the Sprague-Dawley strain will be obtained from 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). o Temperature: 22C + 2 Q o Relative humidity: 50% +20% o Air change: At least 10 changes an hour of filtered 100% outside air o 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.
001056
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 screen-bottom stainless steel cages held on racks, with absorbent pan liners in the urine- and feees-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*. 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 .
001057
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, whether 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 .
G0105S
5 Maintenance of Raw Data and Records
Original data or copies thereof will 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).
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PROTOCOL APPROVAL
Jai m e Gleason msor's Representative
3M
Steven M. Glaza Study Director Group Leader, Acute Toxicology Hazleton Laboratories America, Inc .
(ll07S/tji)
flw fe s -
________ S - 2 . 2 . - * ^ Date
601060
