Document kgVn20BJ6eYg7Oyxn3dBnjMB
uaS"
Estrous Cycling and Natural Delivery/Litter Observation Data
FI Estrous Cycling Data, From Data Analysis Presented at EPA on August 30,2002"
APFO Dose Group (mg/kg/day)
0 1 3 10 30
All 4-Day
14/30
19/29
9/30
15/29
15/30
Cycles
3-5 Day Cycles
24/30
26/29
21/30
25/29
27/30
Cycle Length (Days) 2 3 4 5 6 7 8
Mean Cycle Length (Days)
S.D.
1 2 75 18 5 1 2 4.3 0.8
Incidence of Cycle Length Per Group
0 1 80 16 2 1 0 4.2 0.5
5 7 57 32 5 0 1 4.3 0.9
2 5 84 14 3 0 0
4.1 0.6
5 5 86 17 0 0 2 4.1 0.8
> 4 Days Diest. > 3 Days Est.
> 4 Days Diest. > 3 Days Est.
2 17
5 25
Aberrant Cycles * Parental
11 13 15
FI 33 25 29
4 16
5 11
P E M D
End in Estrous
Distribution of Cycle Status at Start of 21-Day Evaluation Period, FI
14
12
8 10 11 14
62 2 0
15 13 16 13
Distribution Rats in Estrous at End of 21-Day Evaluation Period, FI
13 17 18 19
1 13
3 14
5 11 2 12
19
hO C-i;
P '0
CD
C--~5I
I
ro
2?*
co cn
vjO
Mean Implantations, Liveborn, and Stillborn S.D. per Litter by Group"
Parental Litters
Implantations
15.3 1.9
15.6 2.1
15.2 2.3
15.6 2.0
15.3 2.0
Livebom
14.2 2.2
14.2 2.6
13.4 3.6
13.8 3.0
13.4 3.3
Stillborn
0.1 0.3
0.4 1.4
0.2 0.4
0.1 0.4
0.2 0.6
FI Litters
Implantations
14.8 3.0
15.8 2.1
14.7 2.8
15.0 2.9
14.5 2.9
Livebom
13.6 2.9
13.7 2.4
13.8 3.0
13.5 3.1
13.3 2.8
Stillborn
0.2 0.5
0.2 0.5
0.2 0.6
0.2 0.5
0.1 0.2
aOriginal analysis counted cycles from the day following estrous (or proestrous if diestrus followed
proestrous without observation of estrous) to the day following the end of the next estrous. The numbers
in this table have been reduced by one day to corespond to the new analysis presented in this submission,
in which cycles were counted from the day following estrous to the last day of the next estrous.
000046
*The definitions of aberrant cycles come from Daston, G. and Kimmel, C. (Eds), 1998. An Evaluation of Reproductive Endpoints for Human Health Risk Assessment. ILSI (November, 1998). Data presented is from evaluation of raw cycling data from ARGUS Research study 418-020, submitted with this table.
c This data was not discussed on August 30, 2002; however, it was agreed to represent these data in htis submission. The data are from Tables Cl 9, C20, E20, and E21 of the final report on the APFO multi generation reproduction/developmental study which has been previously submitted to AR-226.
000047
Estrous Cycling and Natural Delivery/Litter Observation Data
FI Estrous Cycling Data, From Data Analysis Presented at EPA on August 30, 2002"
APFO Dose Group (mg/kg/day)
0 1 3 10 30
All 4-Day
14/30
19/29
9/30
15/29
15/30
Cycles
3-5 Day Cycles
24/30
26/29
21/30
25/29
27/30
Cycle Length (Days) 2 3 4 5 6 7 8
Mean Cycle Length (Days)
S.D.
1 2 75 18 5 1 2 4.3 0.8
Incidence of Cycle Length Per Group
0 1 80 16 2 1 0 4.2 0.5
5 7 57 32 5 0 1 4.3 0.9
2 5 84 14 3 0 0 4.1 0.6
5 5 86 17 0 0 2
4.1 0.8
Aberrant Cycles4
Parental
4 Days
2
11
4
1
Diestrous
3 Days
17
13
15
16
13
Estrous
FI
4 Days
5
3
3
5
3
Diestrous
3 Days
25
25
29
11
14
Estrous
P E M D
End in Estrous
Distribution of Cycle Status at Start of 21-Day Evaluation Period, FI 14 12 8 10 11 14 6 22 0 15 13 16 13
Distribution Rats in Estrous at End of 21-Day Evaluation Period, FI 13 17 18 19
5 11 2 12
19
Mean Implantations, Liveborn, and Stillborn S.D. per Litter by G roupc
Parental Litters
Implantations
15.3 1.9
15.6 2.1
15.2 2.3
15.6 2.0
15.3 2.0
Liveborn
14.2 2.2
14.2 2.6
13.4 3.6
13.8 3.0
13.4 3.3
Stillborn
0.1 0.3
0.4 1.4
0.2 0.4
0.1 0.4
0.2 0.6
FI Litters
Implantations
14.8 3.0
15.8 2.1
14.7 2.8
15.0 2.9
14.5 2.9
Liveborn
13.6 2.9
13.7 2.4
13.8 3.0
13.5 3.1
13.3 2.8
Stillborn
0.2 0.5
0.2 0.5
0.2 0.6
0.2 0.5
0.1 0.2
"Original analysis counted cycles from the day following estrous (or proestrous if diestrus followed
proestrous without observation of estrous) to the day following the end of the next estrous. The numbers
000048
in this table have been reduced by one day to corespond to the new analysis presented in this submission, in which cycles were counted from the day following estrous to the last day of the next estrous. The definitions of aberrant cycles come from Daston, G. and Kimmel, C. (Eds), 1998. An Evaluation of Reproductive Endpoints for Human Health Risk Assessment. ILSI (November, 1998). Data presented is from evaluation of raw cycling data from ARGUS Research study 418-020, submitted with this table. This data was not discussed on August 30, 2002; however, it was agreed to represent these data in htis submission. The data are from Tables C 19, C20, E20, and E21 of the final report on the APFO multi generation reproduction/developmental study which has been previously submitted to AR-226.
000049
