Document nkvB7Be4ymnvE9je3OXZxR3ow
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 Cycles
Parental
> 4 Days Diest.
2
1
14
1
> 3 Days Est.
17
13
15
16
13
FI
> 4 Days Diest.
5
3
3
5
3
> 3 Days Est.
25
25
29
11
14
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
6220
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 Group c
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
F I 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
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 from evaluation of raw cycling data from ARGUS Research study 4 18-020, 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 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.
