Document g2NKV7Nkzvodz77DB72qr345Q
905 Sheehy Drive, fiUg. A Horsham. PA 19044 Telephone: (215) 443-8710 Telefax: (215)443-8587
ARGUS RESEARCH
Charles River Laboratories
Discovery and Development Services
September 11, 2002
John Butenhoff, Ph.D., DABT, CIH 3M Corporate Toxicology 3M Medical Department 3M Center, Building 220-2E-02 St. Paul, Minnesota 55144-1000 Telephone: (651) 733-1962 Telefax: (651) 733-1773 RE: Protocol 418-020 - Oral (Gavage) Two-Generation (One Litter per Generation)
Reproduction Study of Ammonium Perfluorooctanoate (APFO) in RSpaotsnsor's Study Number: T-6889.6 Dear Dr. Butenhoff: Enclosed are the copies of the estrous cycle evaluation for P and FI generation rats which you requested. If you have any questions, please do not hesitate to contact me.
Sincerely,
Jo Ann Frazee, M.S. Study Coordinator Enc.
002947*
ESTROUS CYCLE EVALUATION P GENERATION FEMALE RATS
EXACT COPY
Oo 3 ^ 7
Argus
[PRO TO CO L:
TE S T A R TIC LE /S U B S TA N C E :
TYPE OF TEST:
W18 -0 2 0 DOSAGE: |o (Vehicle) MKD
P = Proestrus
APFO G E N ER A TIO N : P
ROUTE: Oral (Gavage)
Estrous Cycle Evaluation S P E C IE S /S TR A IN : Rat/Crl:CD (SD) IGS BR VAF/Plus
E = Estais
M = Metestais
D = Diestrus
DATE
i-i-o l i,l o i 1-3-6) W l /-f-ol
1-5 ?t ' -HOi l-i.ei h u m iikA i-13-a HOf
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Tech/Time II23
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13801
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002948
Argus
PROTOCOL:
418-020 DOSAGE:
0 (Vehicle) MKD P = Proestrus E = Estais M = Metestrus
TE S T A R TIC LE /S U B S TA N C E :
APFO G E N ER A TIO N : P
ROUTE: Oral (Gavage)
TYPE OF TEST: Estrous Cycle Evaluation S P E C IE S /S TR A IN : Rat/Crl:CD (SD) IGS BR VAF/Plus
DATE
Animai: Number 13813 13814 13815 13816 13817 13818 13819 13820 13821 13822 13823 13824 13825 13826 13827 13828 13829 13830
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Date: .I-CfAL
RT 01.14.00 EC2-04b
EXACT COPY
002949
PROTOCOL: 4 1 8 -0 2 0 DOSAGE: 1 MKD P = Proestrus E = Estais M = Metestais
Argus
T E S T A R TIC LE /S U B S TA N C E :
AP FO G E N ER A TIO N : P
ROUTE: Oral (Gavage)
TYPE OF TEST: Estrous Cycle Evaluation S PE C IE S /S TR A IN : Rat/Crl:CD (SD) IGS BR VAF/Plus
DATE
Animal Number 13831 13832 13833 13834 13835 13836 13837 13838 13839 13840 13841 13842 13843 13844 13845 13846 13847 13848 13849
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002950
PROTOCOL: 4 1 8 -0 2 0 DOSAGE: 1 MKD P = Proestrus E = Estais M = Metestais D = Diestois
DATE
Animal Number 13850 13851 13852 13853 13854 13855 13856 13857 13858 13859 13860
A rgus
T E S T A R TIC LE/S U BSTANC E:
APFO G E N ER A TIO N : P
ROUTE: Oral (Gavage)
TYPE OF TEST: Estrous Cycle Evaluation S P E C IE S /S TR A IN : Rat/Crl:CD (SD) IGS BR VAF/Plus
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Reviewed By:_____________________ 'tifi , A % AL.- Date:
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002951
Argus
PROTOCOL:
TE S T A R TIC LE/S U B S TA N C E:
TYPE OF TEST:
4 1 8 -0 2 0 DOSAGE: 3 MKD P = Proestrus
APFO G E N E R A TIO N : P
ROUTE: Oral (Gavage)
Estrous Cycle Evaluation S P E C IE S /S TR A IN : Rat/Crl:CD (SD) !GS BR VAF/Plus
E = Estrus
M = Metestrus
D = Diestrus DATE
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Animal Number
13861 13862
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Reviewed By:___
/ 1 l/ u L t
D ate; ___________ -----------------------------RT 01.14.00 EC2-04b
EXACT COPY
jij- cUulo^-
002952
PROTOCOL: 4 1 8 -0 2 0 DOSAGE: 3 MKD P = Proestrus E = Estais M = Metestrus D = Diestais
DATE
Animal Number 13880 13881 13882 13883 13884 13885 13886 13887 13888 13889 13890
A rgus
T E S T A R TIC L E /S U B S TA N C E :
APFO G E N E R A TIO N : P
ROUTE: Orai (Gavage)
TYPE OF TEST: Estrous Cycle Evaluation S P E C IE S /S TR A IN : Rat/Crl:CD (SD) IGS BR VAF/Plus
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4 ld Reviewed By:______ ______________ f t l .'It A s f c
_ Date:________ H - 0 / _________ RT 01.14.00 EC2-04b
EXACT COPY
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002953
PROTOCOL: 4 1 8 -0 2 0 DOSAGE: 10MKD
T E S T A R TIC LE /S U B S TA N C E :
APFO G E N ER A TIO N : P
ROUTE: Oral (Gavage)
TYPE OF TEST: Estrous Cycle Evaluation S P E C IE S /S TR A IN : Rat/Crl:CD (SD) IGS BR VAF/Plus
P = Proestrus
E = Estrus
M = Metestrus
DATE /-/-ol \m l-3fi( H , l.T'Ol 1-4r*t
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1 2 3 4 5 6 7 8 9 10 11 12 13 14
Animal Number 13891
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Reviewed By:
% Date: M J _ RT 01.14.00 EC2-04b
002954
Argus
PROTOCOL:
TE S T A R TIC LE/S U B S TA N C E:
TYPE OF TEST:
418-020 DOSAGE: 10 MKD
APFO G EN ER A TIO N : P
ROUTE: Oral (Gavage)
Estrous Cycle Evaluation S P E C IE S /S TR A IN : Rat/Crl:CD (SD) IGS BR VAF/Plus
P = Proestrus
E = Estais
M = Metestais
D = Diestais DATE
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Animal Number
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13911 13912 13913
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13914 13915
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13917
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Reviewed By:_____
w . / hhaa ^ _____ _ Date:
l ~ l 0 l _____________ _ RT 01.14.00 EC2-04
|EXACT COPY
J ^7 Rlulo^-
002955
Argus
PROTOCOL:
T E S T A R TIC LE /S U B S TA N C E:
TYPE OF TEST:
4 1 8 -0 2 0 DOSAGE: 30 MKD
APFO G E N E R A TIO N : P
ROUTE: Oral (Gavage)
Estrous Cycle Evaluation S P E C IE S /S TR A IN : Rat/Crl:CD (SD) IGS BR VAF/Plus
P = Proestrus
E = Estrus
M = Metestrus
D = Diestnjs DATE
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1 2 3 4 5 6 7 8 9 10 11 12 13 14
Animal Number 13921 13922
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13923 13924 13925 13926 13927 13928 13929 13930 13931 13932 13933 13934 13935 13936 13937 13938
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Reviewed By:______ _______________ t o . ' r n / t j f c _____ D aie:-- t i d u -- :--------------------RT 01.14.00 EC2-04b
I EXACT COPY
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002956
A rgus
PROTOCOL: 4 1 8 -0 2 0 DOSAGE: 30 MKD
TE S T A R TIC LE /S U B S TA N C E :
AP FO G E N E R A TIO N : P
ROUTE: Oral (Gavage)
TYPE OF TEST: Estrous Cycle Evaluation S P E C IE S /S TR A IN : Rat/Crl:CD (SD) IGS BR VAF/Plus
P = Proestrus
E = Estrus
M = Metestnjs
D = Diestrus DATE
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3 4 5 6 7 8 9 10 11 12 13 14
Animal Number 13940
b
b
13941 13942
D (F b
b Bb
13943 13944 13945 13946 13947
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13948
b "D b
13949 13950
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RT 01.14.00 EC2-04
' e \CT COPY \
00295
Argus
PROTOCOL: 4 1 8 -0 2 0 DOSAGE: 0 (Vehicle) MKD
T E S T A R TIC LE/S U B S TA N C E: APFO G E N E R A TIO N : R O U TE: P ' Oral (Gavage)
TYPE OF TEST: Estrous Cycle Evaluation S P E C IE S /S TR A IN : Rat/Crl:CD (SD) IGS BR VAF/Plus
P = Proestrus
E = Estrus M = Metestrus D = Diestais
DATE
'IS o 1
2
Saline Pre-Check VWt / 1 1 * Tech/Time II 3 b"
i-17-oi 1-4 <* 34 5
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3*4
ip d7
mi js a m .
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9 10 11 12 13 r
4ft-/ <3*4 J*iL Saline Post
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Check Tech/Time IZ \i> \Z U f i , 1-300 i \ a
S'
Smears Taken Tech/Time Start
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3 *4
Smears Taken
Time End
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Smears Read v W Tech/Time Start \ v n 114-3
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Smears Read Time End a H I IZ& o I30*f iP5t
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Animal Number 13801
p
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13802 13803
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13804
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13805
f>
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13810
FV n p m n
13811
bP b
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13812
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T> D 0
Reviewed By:
Date:
in ird c F
t r i b j j U H C t J . ^CJ ' / n j a /
RT 01.14.00 EC2-04a
EXACT COPY
.R {u lo >
002958
PROTOCOL:
4 1 8 -0 2 0 DOSAGE:
0 (Vehicle) MKD P = Proestrus E = Estais M = Metestais
Argus
TEST A R TIC LE /S U B S TA N C E : APFO G EN ER A TIO N : R O U TE: P Oral (Gavage)
TYPE OF TEST: Estrous Cycle Evaluation SPECIES/STRA 1N : Rat/Crl:CD (SD) IGS BR VAF/Plus
DATE
Animal Number 13813 13814 13815 13816 13817 13818 13819 13820 13821 13822 13823 13824 13825 13826 13827 13828 13829 13830
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Reviewed By:
Date:
RT 01.14.00 EC2-04b
002959
PROTOCOL: 418-020 DOSAGE: 1 MKD P = Proestrus E = Estais M = Metestrus D = Diestrus
DATE
Animal Number 13831 13832 13833 13834 13835 13836 13837 13838 13839 13840 13841 13842 13843 13844 13845 13846 13847 13848 13849
Argus
TE S T A R T1C LE/SU B STA N C E:
APFO G E N E R A TIO N : P
ROUTE: Oral (Gavage)
TYPE OF TEST: Estrous Cycle Evaluation SPEC1ES/STRA IN : Rat/Cri:CD (SD) IGS BR VAF/Plus
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Date:
RT 01.14.00 EC2-04b
EXACT COPY
- h iu io >
PROTOCOL: 4 1 8 -0 2 0 DOSAGE: 1 MKD P = Proestrus E = Estais
Argus
TE S T A R TIC LE/S U B S TA N C E:
APPO G E N E R A TIO N : P
ROUTE: Oral (Gavage)
002960
TYPE OF TEST: Estrous Cycle Evaluation S P E C IE S /S TR A IN : Rat/Crl:CD (SD) IGS BR VAF/Plus
Reviewed By:
Date:
OT ru 1Ann p n o M A .h
, ,7 J
002961
A rgus
PROTOCOL:
TE S T A R TIC LE/S U B S TA N C E:
TYPE OF TEST:
418-020 DOSAGE:
APFO G E N E R A TIO N : RO UTE:
Estrous Cycle Evaluation S P E C IE S /S TR A IN :
3 MKD
P
Oral (Gavage)
Rat/Crl:CD (SD) IGS BR VAF/Plus
P = Proestrus
E = Estais
M = Metestrus
D = Diestms
DATE l-tfol Ht*Ol irtt\ Ii9*i
pao-oi Itfl-ol
1 23456 78
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Date:
RT 01.14.00 EC2-04b
[EXACT COPY
002962
PROTOCOL: 4 1 8 -0 2 0 DOSAGE: 3 MKD p = Proestrus E = Estais M = Metestais
Argus
T E S T A R T1C LE/SU B STA N C E:
APFO G E N E R A TIO N : P
ROUTE: Oral (Gavage)
TYPE OF TEST: Estrous Cycle Evaluation S P E C IE S /S TR A IN : Rat/Crl:CD (SD) IGS BR VAF/Plus
DATE
/K<J
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Date:
RT 01.14.00 EC2-045
q ju /o i. 1#
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002963
Argus
PROTOCOL:
TE S T A R TIC LE /S U B S TA N C E :
TYPE OF TEST:
418-020 DOSAGE:
APFO G E N ER A TIO N : R O U TE:
Estrous Cycle Evaluation S PE C IE S /S TR A IN :
10MKD
P
Oral (Gavage)
Rat/Crl:CD (SD) IGS BR VAF/Plus
P = Proestrus
E = Estrus
M = Metestrus
D = Diestrus
DATE
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Animal Number 13891 13892 13893
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Date:
RT 01.14.00 EC2-04b
usi----- .
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PROTOCOL: 4 1 8 -0 2 0 DOSAGE: 10 MKD P = Proestrus E = Estais M = Metestais D = Diestius
Argus
TE S T A R T1C LE/SU B STA N C E: APFO G E N ER A TIO N : RO UTE: P Oral (Gavage)
002964
TYPE OF TEST: Estrous Cycle Evaluation S P E C IE S /S TR A IN : Rat/Crl:CD (SD) IGS BR VAF/Plus
Q>@ ISO* Reviewed By:_______ _________________________________ Date:
RT 01.14.00 EC2-04
ft
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002965
Argus
PROTOCOL:
T E S T A R TIC LE/S U B S TA N C E:
4 1 8 -0 2 0 DOSAGE: 30 MKD P = Proestrus
APFO G E N E R A TIO N : P
ROUTE: Oral (Gavage)
E = Estais
M = Metestrus
D = Diestais DATE
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Animal Number 13921 13922 13923 13924 13925 13926 13927 13928 13929 13930 13931 13932 13933 13934 13935 13936 13937 13938 13939
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TYPE OF TEST: Estrous Cycle Evaluation S P E C IE S /S TR A IN : Rat/Crl:CD (SD) IGS BR VAF/Plus
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Reviewed By:
EXACT COPY
PROTOCOL: 418-020 DOSAGE: 30 MKD P = Proestais E = Estrus M = Metestrus
Argus
TE S T A R TIC LE/S U B S TA N C E:
APFO G E N E R A TIO N : P
ROUTE: Oral (Gavage)
002966
TYPE OF TEST: Estrous Cycle Evaluation S P E C IE S /S TR A IN : Rat/Crl:CD (SD) IGS BR VAF/Plus
DATE
/ 1*7-01 12
Animal Number
13940 13941
6 fs
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13942 13943 13944
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13945 13946 13947 13948 13949 13950
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012431
ESTROUS CYCLE EVALUATION F1 GENERATION FEMALE RATS
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PROTOCOL: 418-020 DOSAGE: 0 MKD
P = Proestrus E = Estrus M = Metestrus
Argus
TE S T A R TIC LE/SU B STA N C E: APFO G E N ER A TIO N : RO UTE: F1 Oral (Gavage)
TYPE OF TEST:
I
Estrous Cycle Evaluation
S P E C IE S /S TR A IN :
Rat/Crl:CD (SD) IGS BR VAF/Plus |
DATE
p-t-O film 12
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Reviewed By:
I f c Date:
f*kl*eUjuJUi<n'>W- o f pCw*^KcM>jrOm*J-YU`t*' ^ u3b-b^. ki~'lH (i4i
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012433
Argus
PROTOCOL: 418-020 DOSAGE: IO MKD
TE S T A R TIC LE/S U B S TA N C E:
APFO G E N E R A TIO N : F1
ROUTE: Oral (Gavage)
TYPE OF TEST: Estrous Cycle Evaluation S P E C IE S /S TR A IN : Rat/Crl:CD (SD) IGS BR VAF/Plus
P = Proestrus
E = Estrus M = Metestrus
D= Diestrus DATE
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1 2 3 4 5 6 7 8 9 10 11 12 13 14
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Reviewed By:_
-
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5-n-i
-- . Date:-- -r / L / L ----------------------RT 01.14.00 EC2-04b
Ex a c t c o py
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012434
Argus
PROTOCOL:
TE S T A R TIC LE/S U B S TA N C E:
TYPE OF TEST:
418-020 DOSAGE: 1 MKD
APFO G EN ER A TIO N : RO U TE: F1 Oral (Gavage)
Estrous Cycle Evaluation S PE C IE S /S TR A IN : Rat/Crl:CD (SD) IGS BR VAF/Plus
P = Proestrus
E = Estais
M = Metestrus
D = Destais
DATE
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Date:
RT 01.14.00 EC2-04b
COPY V
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012435
Argus
PROTOCOL: 418-020 DOSAGE: 1 MKD
TEST A R TIC LE/SU B STA N C E:
APFO G E N ER A TIO N : F1
ROUTE: Oral (Gavage)
TYPE OF TEST:
I
Estrous Cycle Evaluation S P E C IE S /S TR A IN :
Rat/Crl:CD (SD) IGS BR VAF/Plus
P = Proestrus
E = Estrus
M = Metestrus
D = Diestrus
DATE
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Reviewed By:
Date:
RT 01.14.00 EC2-04b
012436
PROTOCOL: 4 1 8 -0 2 0 DOSAGE: 3 MKD P = Proestrus
Argus
TE S T A R TIC LE/SU B STA N C E:
APFO G E N ER A TIO N : F1
ROUTE: Oral (Gavage)
TYPE OF TEST: Estrous Cycle Evaluation S P E C IE S /S TR A IN : Rat/Crl:CD (SD) IGS BR VAF/Plus
E = Estais
UICUUM = Metestrus
U--
DATE
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Date:
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012437
Argus
Ip R O TO CO L: W18 -0 2 0 DOSAGE: 3MKD
T E S T A R TIC LE/SU B STA N C E:
APFO G E N ER A TIO N : F1
ROUTE: Oral (Gavage)
TYPE OF TEST: Estrous Cycle Evaluation S P E C IE S /S TR A IN : Rat/Crl:CD (SD) IGS BR VAF/Plus
P = Proestrus
E = Estais
M = Metestrus
u = uiestrus DATE
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Date:
-r / ? -*-/u RT 01.14.00 EC2-04b
EXACT COPY
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012438
Argus
PROTOCOL:
TE S T A R TIC LE /S U B S TA N C E :
TYPE OF TEST:
418-020 DOSAGE: 10MKD
APFO G E N ER A TIO N : F1
ROUTE: Oral (Gavage)
Estrous Cycle Evaluation S P E C IE S /S TR A IN : Rat/Cri:CD (SD) IGS BR VAF/Pius I
P = Proestrus E = Estais
M = Metestrus
D = Diestais
DATE
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S '/z '/o l RT 01.14.00 EC2-04b
012439
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[PROTOCOL: 1*1 8-020 DOSAGE: [10 MKD
TEST ARTICLE/SUBSTANCE:
APFO G E N E R A T IO N : F1
ROUTE: Oral (Gavage)
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PROTOCOL:
TEST ARTICLE/SUBSTANCE:
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418-020 DOSAGE:
APFO GENERATION: ROUTE:
Estrous Cycle Evaluation S P E C IE S /S T R A IN :
30MKD
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TEST ARTICLE/SUBSTANCE:
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PROTOCOL:
Test Article/Substance:
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418-020 DOSAGE:
0 MKD
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PROTOCOL: 418-020 DOSAGE:
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ROUTE:
F1 Oral (Gavage)
Type of Test: Estrous Cycle Evaluation
Species/Strain: Rat/Crl:CD (SD) IGS BR VAF/Plus
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Date
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Argus
PROTOCOL: 418-020
Test Articie/Substance: APFO
Type of Test: Estrous Cycle Evaluation
DOSAGE: 1 . 0 MKD
G E N E R A T IO N : F1
ROUTE: Oral (Gavage)
S p e c ie s /S tra in : Rat/Crl:CD (SD) IGS BR VAF/Plus
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Date
ANIMAL NUMBER
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012445
Argus
PROTOCOL: 418-020 DOSAGE:
1 . 0 MKD
Test Article/Substance: APFO
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ROUTE:
F1 Orai (Gavage)
Type of Test: Estrous Cycle Evaluation
S p e c ie s /S tra in : Rat/Crl:CD (SD) IGS BR VAF/Plus
P = Proestrus E = Estrus M = Metestrus D = Diestrus
Date
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[exact copy
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PROTOCOL: 418-020 DOSAGE:
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Test Articie/Substance: APFO
G E N E R A T IO N :
ROUTE:
F1 Oral (Gavage)
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Date:
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PROTOCOL: 418-020 DOSAGE:
3 . 0 MKD
P = Proestrus E = Estais M = Metestrus
Argus
Test Article/Substance: APFO
GENERATION:
ROUTE:
F1 Oral (Gavage)
012447
Type of Test: Estrous Cycle Evaluation
Species/Strain: Rat/Cri:CD (SD) IGS BR VAF/Plus
Date
5 iSLbA 1
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PROTOCOL: 418-020 DOSAGE:
1 0 . 0 MKD
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Test Article/Substance: APFO
G E N E R A T IO N :
ROUTE:
F1 Oral (Gavage)
Type of Test: Estrous Cycle Evaluation
Species/Strain: Rat/Crl:CD (SD) IGS BR VAF/Plus
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PROTOCOL: 418-020
Test Article/Substance: APFO
Type of Test: Estrous Cycle Evaluation
DOSAGE: 1 0 . 0 MKD
G E N E R A T IO N : F1
ROUTE: Oral (Gavage)
S p e c ie s /S tra in : Rat/Crl:CD (SD) IGS BR VAF/Plus
P = Proestrus E = Estrus M = Metestrus D = Diestrus
Date
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Argus
PROTOCOL: 418-020
DOSAGE:
3 0 . 0 MKD
P = Proestrus E = Estrus M = Metestrus D = Diestrus
Date
Test Articie/Substance: APFO
G E N E R A T IO N :
ROUTE:
F1 Oral (Gavage)
Type of Test: Estrous Cycle Evaluation
Species/Strain: Rat/Crf:CD (SD) IGS BR VAF/Plus
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PROTOCOL: 418-020 DOSAGE:
3 0 . 0 MKD
P = Proestrus E = Estrus M = Metestrus
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Test Articie/Substance: APFO
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Type of Test: Estrous Cycle Evaluation
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