Document OzzkvX4eg3OkrBZ0MkxDQzkR1
Perluorooctanpsulfonate:
PK During Pregnancy and Lactation + Analytical Protocol
M.
."
PROTOCOI, 418-008.
COMBINED ORAL (GAVAGE) FERTII,11'Y, DEVELOPMENTAL PFOS IN RATS (SPONSOR'S STUDY NUMBER: 6295.9)
AND PERINATAI,/POSTNATAL
REPRODUCTION TOXI
TABLE E20 (PAGE 1): I,ITTER OBSERVATIONS (NATURAI.1,Y DELIVERED PUPS) - SI)MMARY - F2 GENERATION LlrrERS
----------------- - ---
------- ----------- - -----------------I- - --------------------------------
MATERNAL DOSAGE GROUP
1
11
111
HATERNAI, DOSAGE (MG/KG/I)AY)
0 (VEHICI,E)
0.1
0.4
----------------------- ---------------------- ----------------------- ---------------------------------
DELIVERED LITTERS WITH
ONE OR MORE LIVEBORN PUPS
N
22
21
24
PUPS DELIVERED ITOTAL)
N MEAN+S.D.
316 14.4 + 3.5
325 15.5 4 2.5
357 14.9 + 2.6
LIVEBORM
MEAN+S.D. N(i)
14.1 + 3.5 310( 9-8.1)
15.1 + 2.4 318( 97.8)
14.3 + 2.5 344( 9i.4)
STILLBORN
MEAN+S.D. N(i)
0.3 4 0.6 6( 1.9)
0.3 + 1.1 7( 2.2)
0.5 + 0.9 13( i.6)
PUPS FOUND DEAD OR PRESUMED CANNIBALIZED
DAY
I
DAYS 2- 4
DAYS 5- 7 DAYS B-14
DAYS 15-21
VIABILITY INDEX b
NIN(%) HIN(%) NIN(%) HIN(%) NIN(%)
% NIN
2/310( 7/308( 0/171( 0/171( 0/171(
0.6) 2.3) 0.0) 0.0) 0.0)
97.1 301/310
2/318( 2/326( 2/167( 1/165( 0/164(
0.6) 0.6) 1.2) 0.6) 0.0)
98.7 314/318
2/344( 21/342(
5/291( 1/178( 0/177(
0.6) 3.2) 2.6) 0.6)a 0.0)a
96.2 331/344
LACTATION INDEX c
%
100.0
98.2
96.7
NIN
171/171
164/167
177/183
-------------------------------------------------------------------------------------------------------------
DAY(S) - DAY(S) POSTPARTUM
a. Excludes values for litter 13257; the dam was found dead on day 10 of lactation; eight pups were sacrifi
b. Number of live pups on day 4 (preculling) postpartum/number of liveborn pups on day I postpartum.
c. Number of live pups on day 21 (weaning) postpartum/number of live pups on day 4 (poetculling) postpartum
PROTOCOL 418-008:
COMBINED ORI@L (GA"GE) FERTILITY, DEVEI,OPMENTAL PFOS IN RAT!; (SPONSOR'S STUDY NUMBER: 629S.9)
AND PERINATAL/POSTNATAL
REPRODUCTION TOXI
TABLE E20 (PAGE 1); LITTER OliSERVATIONS (NATURALLY DELIVERED PUPS) - SUMMARY - F2 GENERATION LITTERS
-- ------------------------- ...........- --------- --
MA'I'ERNAL DOSAGE GROUP
I
MATERNAL DOSAGE (MG/KG/DAY)
0 (VEHICLE)
.. ................................................
DELIVERED LITTERS WITH
ONE OR MORE LIVEBORN PUPS
N
22
------------- ------- - ------------------------
ii
III
0.1
0.4
..............................................
21
24
SURVIVING PUPS/LITTER a
DAY I b DAY 4 PRECULLING DAY,.4 POSTCULLING DAY 7 DAY 14 DAY 21 PERCENT MALE PUPS PER NUMBER OF PUPS SEXED
MEAN*S.D. MEAN+S.D. MEAN+S.D. MEAN+S.D. MEAN+S.D. MEAN+S.D.
14.1 + 3.5 13.7 + 3.3
7.8 + 0.8 7.8 + 0.8 7.8 + 0.8 7.8 + 0.8
15.1 + 2.4 15.0 + 2.8
8.0 + 0.2 7.8 + 0.5 7.8 + 0.7 7.8 + 0.7
14.3 + 2.5
13.8 + 2.4
8.0 + 0.2
7.6 + 0.7
7.7 + 0.8 I 2i] C
7.7 + 0.0 24)c
DAY I b
MEAN+S.D.
47.9 + IS.2
S2.1 + 10.9
47.0 + 13.3
DAY 4 PRECULLING
MEAN+S.D.
47.9 + 15.1
51.5 + 11.1
46.6 + 13.4
DAY 4 POSTCULLING
MEAN+S.D.
47.0 + 10.0
49.6 + 1.6
49.1 + 5.7
DAY 7
MEAN*S.D.
47.0 + 10.0
48.9 + 3.9
48.7 + 6.4
DAY 14
MEAN+S.D.
47.0 + 10.0
49.2 + 2.6
48.3 + 6.2
DAY 21
MEAN+S.D.
47.0 + 10.0
49.2 + 2.6
( 24)c 48.3 + 6.2
[ 24)c -------------------------------------------------------------------------------------------------------------
DAY - DAY POSTPARTUM
- NUMBER OF VALUES AVERAGED
a. Average number of live pups per litter, including litters with no surviving pups. b. Includes pups born alive, found dead day 1 postpartum.
c. Excludes values for litter 13257; the dam was found dead on day 10 of lactation; eight pups were eacrifi
PROTOCOL, 418-008:
COMBINED ORA[, (GAVAGE) FERTILITY. DEVELOPMENTAL PFOS IN RATS (SPONSOR'S STUDY NUMBER: 6295.9)
AND PERINATAL/POSTNATAL
REPRODUCTION TOXIC
TABI,E E20 (PAGE 3): Lil'TER OBSERVATIONS (NATURALLY R)EI,IVERED PUPS) - SUMMARY
F2 GENERATION LITTERS
...... .......
-------------------- --- -
MA*I'L'RNAI,DOSAGE (JROUII
1
11
111
MATERNAL DOSAGE (MG/KG/I)AY)
0 IVEIIICLE)
0.1
0.4
... ............................................. .........................................................
DELIVERED LITTERS WITH
ONE OR MORE LIVEHORN PUPS
N
22
21
24
LIVE LITTER SIZE AT WEIGHING
DAY I
MEAN+S.D.
14.0 + 3.5
15.0 + 2.6
14.2 + 2.5
DAY 4 PRECULLING
MEAN+S.D.
13.7 + 3.3
1S.0 + 2.8
13.8 + 2.4
DAY 4 POSTCULLING
MEAN+S.D.
7.8 + 0.8
8.0 + 0.2
7.9 + 0.3
DAY 7
MEAN+S.D.
7.8 + 0.8
7.8 + 0.5
7.8 + 0.7
DAY 14 DAY 21 PUP WEIGHT/LITTER
MEAN+S.D. MEAN+S.D. (GRAMS)
7.8 + 0.8 7.8 + 0.8
7.8 + 0.7 7.8 + 0.7
7.7 + 0.8 ( 23)a
7.7 + 0.8 23)a
DAY 1
HEAN+S.D.
6.3 + 0.8
6.1 + 0.5
6.2 + 0.5
DAY 4 PRECULLING
MEAN+S.D.
8.7 + 1.6
8.2 + 1.0
8.0 + 1.3
DAY 4 POSTCULLING
MEAN+S.D.
8.8 + 1.6
8.3 + 1.0
8.0 + 1.3
DAY 7
MEAN+S.D.
14.7 + 2.4
13.9 + 2.2
12.8 + 2.6*
DAY 14
MEAN+S.D.
32.0 + 3.5
31.8 + 3.1
28.9 + 4.7**
1 231a
DAY 21
MEAN+S.D.
50.1 + 5.1
49.2 + 5.0
46.5 + 6.3
( 231a --------------------------------------------------------------------------------------------------------------
DAY - DAY POSTPARTUM I ) - NUMBER OF VALUES AVERAGED a. Excludes values for litter 13257; the dam was found dead on day 10 of lactation;
Significantly different from the vehicle control group value (p5O.OS). Significantly different from the vehicle control group value (plo.01).
eight pups
were
socrific