Document DvQkDNe0gxv9ZxqLZw1rXgMMN
Estrous Cycling and Natural Delivery/Litter
Observation Data
F1 Estrous Cycling Data, From Data Analysis Presented at EPA on August 30, 2002 a
APFO Dose Group (mg/kg/day)
0
1
3
10
30
All 4-Day Cycles
3-5 Day Cycles
14/30 24/30
19/29 26/29
9/30 21/30
15/29 25/29
15/30 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 Cycles b Parental
> 4 Days Diest.
2
1
1
4
1
> 3 Days Est.
17
13
15
16
13
F1
> 4 Days Diest.
5
3
3
5
3
> 3 Days Est.
25
25
29
11
14
Distribution of Cycle Status at Start of 21-Day Evaluation Period, F1
P
1
4
1
2
5
E
8
10
11
14
11
M
6
2
2
0
2
D
15
13
16
13
12
Distribution Rats in Estrous at End of 21-Day Evaluation Period, F1
End in Estrous
13
17
18
19
19
Mean Implantations, Liveborn, and Stillborn S.D. per Litter by Group" Parental Litters
Implantations Livebom StiUbom
15.3 1.9 14.2 _: 2.2 0.1 0.3
15.6 2.1 14.2 + 2.6
15.2 2.3 13.4 3.6
0.4 1.4
0.2 0.4
F1 Litters
15.6 + 2.0 13.8 3.0 0.1 0.4
15.3 2.0 13.4 3.3 0.2 0.6
Implantations Livebom
Stillborn
14.8 3.0 13.6 + 2.9
0.2 0.5
15.8 2.1 13.7 2.4
0.2 0.5
14.7 2.8 13.8 3.0
0.2 0.6
15.0 2.9 13.5 3.1
0.2 0.5
14.5 2.9 13.3 2.8
0.1 0.2
a 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 in this table have been reduced by one day to corespond to the new analysis presented in this submission, in which cycles were counted _om the day following estrous to the last day of the next estrous.
bThe def'mitions 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 C19, C20, E20, and E21 of the fmal report on the APFO multigeneration reproduction/developmental study which has been previously submitted to AR-226.