Document 44OrQZLLqjXV6rYOjGymgvL6x
PROTOCOL 418-008:
COMBINED ORAL (GAVAGE) FERTII,11'Y, DEVELOPMENTAL PFOS IN RATS (SPONSOR'S STUDY NUMBER: 6295.9)
AND PF.RINATAt,/ POSTNATAL REPRODUCTION
TOXICITY
TABLE E20 (PAGE 1): I.ITTER OBSERVATIONS (NATURAI.1,Y DELIVERED PUPS) - ST)MMARY F2 GENERATION LITTERS
----------------- - --- ......................
-------------------
MATERNAL DOSAGE GROUP
1
11
HATERNAI, DOSAGE (MG/KG/I)AY)
0 (VEHICI,E)
0.1
----------------------- -----------------------------------------------
DELIVERED LITTERS WITH
ONE OR MORE LIVEHORN PUPS
N
22
21
......-----------------------------111 0.4
--------------------------------------
24
PUPS DELIVERED ITOTAL)
N MEAN+S.D.
316 14.4 + 3.5
325 15.5 + 2.5
357 14.9 + 2.6
LIVEBORN
MEAN+S.D. N(i)
14.1 + 3.5 310( 98.1)
15.1 + 2.4 318( 97.8)
14.3 + 2.5 344( 96.4)
STILLBORN
MEAN+S.D. N(-t)
0.3 + 0.6 6( 1-.9)
0.3 + 1.1 7( i.2)
0.5 + 0.9 13( 3-.6)
PUPS FOUND DEAD OR PRESUMED CANNIBALIZED
DAY DAYS DAYS DAYS DAYS
I 2- 4 S- 7 6-14 IS-21
N/N(t) NIN(lk) N/N(t) N/Nit) NIN(T)
2/310( 7/308( 0/171(
0/171( 0/1714
0.6) 2.3) 0.0)
0.0) 0.0)
2/318( 2/316( 2/167( 1/16S( 0/164(
0.6) 0.6) 1.2) 0.6) 0.0)
2/344( 11/342(
5/191( 1/178( 0/177(
0.6) 3.2) 2.6) 0.6)a 0.0)a
VIABILITY INDEX b
%
NIN
97.1 301/310
98.7 314/318
96.2 331/344
LACTATION INDEX c
t
100.0
98.2
96.7
NIN
171/171
164/167
277/183
------------------------------------------------------------------------------------------------------------------
DAY(S) - DAY(S) POSTPARTUM a. Excludes values for litter b. Number of live pups on day c. Number of live pups on day
13257; the (lam was found dead on day 10 of lactation; eight pups were sacrificed. 4 (preculling) postpartum/number of liveborn pups on day 1 postpartum. 21 (weaning) postpartum/number of live pups on day 4 (postculling) postpartum.
PROTOCOI, 418-008:
COMBINED ORI,I. (GAVAGE) FERTILITY. DEVEI,OPMENTAB PPOS IN RAT!; ISPONSOR'S STUDY NUMSER; 6295.9)
AND PER INATAI,/ POSTNATAL
REPRODUCTION
TOXICITY
TABLE E20 (PAGE 2) 1 LITTER OIISERVATIONS (NATURALLY DEI,IVEIIED PUPS) - SUMMARY - F2 GENERATION LITTERS
-- ------------------------ I ------------ --------- -
MATERNAL, DOSAGE GROUP
1
MATERNAL DOSAGE (MG/KG/DAY)
0 (VEHICLE)
.. ....................................................
DELIVERED LITTERS WITH
ONE OR MORE LIVEBORN PUPS
N
22
---------------------- -----------------------------
11
111
0.1
0.4
...................................................
21
24
SURVIVING PUPS/LITTER a
DAY 1 b
MEAN*S.D.
14.1 + 3.S
15.1 + 2.4
14.3 + 2.5
DAY 4 PRECULLING
MF-kN+S.D.
13.7 + 3.3
15.0 + 2.8
13.8 + 2.4
DAY-.4 POSTCULLING
MEAN+S.D.
7.8 + 0.8
8.0 + 0.2
8.0 + 0.2
DAY 7
HEAN+S.D.
7.8 + 0.8
7.8 + 0.5
7.8 + 0.7
DAY 14
DAY 21
PERCENT KALE PUPS PER NUMBER OF PUPS SEXED
HEAN+S.D. MPM+S.D.
7.8 + 0.8 7.8 + 0.8
7.6 + 0.7 7.8 + 0.7
7.7 + 0.8 1 2ilc
7.7 + 0.8 2i)C
DAY I b
HEAN+S.D.
47.9 + 15.2
S2.1 + 10.9
47.0 + 13.3
DAY 4 PRECULLING
MEAN+S.D.
47.9 + 15.1
Sl.5 + 11.1
46.6 + 13.4
DAY 4 POSTCULLING
MEAN+S.D.
47.0 + 10.0
49.6 + 1.6
49.1 + S.7
DAY 7
MEAN*S.D.
47.0 + 10.0
40.9 + 3.9
48.7 + 6.4
DAY 14
MEAN+S.D.
47.0 + 10.0
49.2 + 2.6
48.3 + 6.2 1 24]C
DAY 21
HEAN+S.D.
47.0 + 10.0
49.2 + 2.6
48.3 + 6.2
2ilc
-----------------------------------------------------------------------------------------------------------------
DAY II a. b. c.
- DAY POSTPARTUM - NUMBER OF VALUES AVERAGED Average number of live pups per litter, including litters with no surviving pups. Includes pups born alive, found dead day 1 postpartum. Excludes values for litter 13257; the dam was found dead on day 10 of lactation; eight
pups
were
sacrificed.
PROTOCOL 418-008:
COMBINED ORAI, IGAVAGE) FERTILITY. DEVELOPMENTAL PFOS IN RATS (SPONSOR'S STUDY NUMBER: 6295.9)
AND PERINATAL/POSTNATAL
REPRODUCTION TOXICITY
TABLE E20 (PAGE 3): LTI'TER OBSERVATIONS (NATURALLY DELIVERED PUPS) - SUMMARY
P2 GENERATION LITTERS
........ .......
MA'I*MRNAI, DOSAGE UROUIP MATERNAL DOSAGE (MG/KG/I)AY) ... .............................
DELIVERED LITTERS WITH
ONE OR MORE LIVEBORM PUPS
N
. ...... .......
1
11
0 IVElilCLE)
0.1
-----------------........................
22
21
---- ----------------- ----111 0.4
--------------------------------
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
15.0 + 2.8
13.8 + 2.4
DAY 4 POSTCULLING DAY 7
MEAN+S.D. HEAN+S.D.
7.8 + 0.8 7.8 + 0.8
8.0 + 0.2 7.8 + 0.5
7.9 + 0.3 7.8 + 0.7
DAY 14 DAY 21 PUP WEIGHT/LITTER
HEAN+S.D. HEAN+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 I
HEAN*S.D.
6.3 + 0.8
6.1 + 0.5
6.2 + 0.5
DAY 4 PRECULLING
HEAN+S.D.
6.7 + 1.6
8.2 + 1.0
6.0 + 1.3
DAY 4 POSTCULLING
HEAN+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 23)a
DAY 21
MEAN+S.D.
50.1 + 5.1
49.2 + 5.0
46.5 + 6.3 [ 23)a
-------------------------------------------------------------------------------------- --------------------------
DAY
II a.
- DAY POSTPARTUM - NUMBER OF VALUES AVERAGED Excludes values for litter 13257;- the dam was found dead on day 10 of lactation;
Significantly different from the vehicle control group value (p!0.05). Significantly different from the vehicle control group value (plO.01).
eight pups
were sacrificed.