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Draft Report
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26-Week Capsule Toxicity Study with Perfluorooctane Sulfonic Acid Potassium Salt (PFOS; T-6295) in Cynomolgus Monkeys
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PREPARED FOR: 3M
COVANCE STUDY NUMBER: 6329-223 VOLUME II of II
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RECEIVED
OPPT HCIC
C O V A ' W C e T''
T H E DEVELOPMENT SERV IC ES COMPANY
Sponsor: 3M
St. Paul, Minnesota
UNAUDITED DRAFT April 12, 2000
FINAL REPORT
Study Title:
26-Week Capsule Toxicity Study with Perfluorooctane Sulfonic Acid Potassium Salt (PFOS; T-6295) in Cynomolgus Monkeys
Author:
Peter J. Thomford, PhD
Study Completion Date:
To be determined
Testing Facility:
Covance Laboratories Inc. 3301 Kinsman Boulevard Madison, Wisconsin 53704-2595 Laboratory Study Identification:
Covance 6329-223 Sponsor Study Identification:
3M Study No. T-6295.7
Volume II of II Page 502 of 821
003133
Covance 6329-223 3M T-6295.7
VOLUME H OF H
CONTENTS
Page
APPENDIX 4 ............................................................................................................................... 504 Individual Clinical Hematology Data.................................................................................. 505 Individual Clinical Chemistry Data................................................................................. 565 Individual Clinical Urinalysis Data...................................................................................... 637
APPENDIX 5 ............................................................................................................................... 685 Individual Palmitoyl CoA Oxidase Determinations.......................................................... 686 Individual Anatomic Pathology Data.................................................................................. 690
APPENDIX 6 ............................................................................................................................... 769 Summary and Individual Blood Hormone Determination.,............................................. 770
APPENDIX 7 ............................................................................................................................... 808 Cell Proliferation Report................................................................................................... 809
00314
503
APPENDIX 4
Individual Clinical Hematology Data Individual Clinical Chemistry Data Individual Clinical Urinalysis Data
Covance 6329-223 3M T-6295.7
504 0 0 3 1 4 1
ANIMAL NUMBER
Group: 1
105508 105517 105519 105520 105526 105527
MEAN S.D. N
Group: 2
105514 105515 105516 105521
MEAN S.D. N
Group: 3
105505 105510 105518 105523 105524 105528
MEAN S.D. N
Appendix 4
Individual Clinical Hematology Data
Males
Day -27
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
RBC HGB HCT MCV MCH MCHC PLT RETIC
xioV^o
G/DL
%
FL
PG
%
X103/jiL
%
Covance 6329-223 3M T-6295.7
RETIC XIOViiL
Dose Level: 0
6.48 6.25 6.97 6.27
6.48 6.27
12.3 12.8 12.5 11.8 12.0 12.1
6.45 .275 6
12.2 .36 6
Dose Level: 0.03
7.28 6.22 6.67 7.79
12.5 11.8 12.5 12.9
6.99 .688 4
12.4 .46 4
Dose Level: 0.15
6.45 6.58 7.36 6.73 6.76 6.67
12.6 11.9 13.0 12.8 13.0 12,6
6.76 .315 6
12.6 .41 6
Dosage Unit: mg/kg/day
40.3 42.4
42.9 39.4 41.1
40.9
62.2 67.8 61.5 62.9
63.5 65.3
19.0 20.5 17.9 18.8
18.6 19.3
41.2 1.30 6
63.9 2.32 6
19.0 .87
6
Dosage Unit: mg/kg/day
45.5 39.8 40.9
45.3
62.5 64.0 61.3 58.1
17.2 18.9 18.7 16.6
42.9 2.95
4
61.5 2.51 4
17.8 1.13 4
Dosage Unit: mg/kg/day
42.0 39.7
44.8 43.1 44.6 43.1
65.2 60.3 60.9 64.1 66.1
64.6
19.6 18.1 17.6 19.0 19.3 18.9
42.9 1.88
6
63.5 2.38 6
18.7 .76 6
30.5 30.2 29.0 29.9 29.3 29.6
29.8 .56 6
27.5 29.6 30.6 28.5
29.0 1.34 4
30.0 29.9 29.0 29.7 29.2 29.3
29.5 .41 6
419 380 577 681 472 652
530 125.0
6
.3 .5 .5 .0 .2 .3
.3 .19
6
469 675 341 813
574 210.3
4
.5 .6 .1 .2
.4 .24 4
469 546 375 569 635 366
493 109.0
6
1.4 .5 .7 .0 .0 .3
.5 .53 6
19 31 35
0 13 19
20 12.6
6
36 37
7 16
24 14.9
4
90 33 52
0 0 20
32 34.5
6
Z&TCOO
505
ANIMAL NUMBER
Appendix 4
Individual Clinical Hematology Data
Males
Day -27
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
RBC HGB HCT MCV MCH MCHC PLT RETIC
XlOV^L
G/DL
FL
PG
%
X10V//L
%
Covance 6329-223 3M T-6295.7
RETIC XIOV/iL
Group: 4
105506 105507 105509 105511 105512 105522
MEAN S.D. N
Dose Level: 0.75
7.63 6.94
6.89 5.90 7.20 6.73
13.4 12.0 11.9 11.4
13.1 13.1
6.88 .575 6
12.5 .82 6
Dosage Unit: mg/kg/day
45.8 41.5 42.3 40.3
44.5 44.1
60.0 59.7 61.4 68.4
61.8 65.5
17.6 17.3
17.3 19.4
18.1 19.5
43.1 2.06 6
62.8 3.44 6
18.2 1.01 6
29.3 28.9 28.1 28.4 29.3 29.7
29.0 .61 6
519 58
409 528 342 636
415 202.6
6
.6 .3 .4 1.4 .2 .1
.5 .47
6
46 21 28 83 14
7
33 27.1
6
506
ANIMAL NUMBER
Group : 1
105508 105517 105519 105520 105526 105527
MEAN S.D. N
Group : 2
105514 105515 105516 105521
MEAN S.D. N
Group: 3
105505 105510 105518 105523 105524 105528
MEAN S.D. N
WBC XIOV^L
Appendix 4
Individual Clinical Hematology Data
Males
Day -27
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
N-SEG
LYMPH
XIOV^L XIOVm L
MONO
EOS IN
XloV/iL x i o V m l
BASO
N-SEG% LYMPH%
X10 /m L
MONO%
EOSIN%
Covance 6329-223 3M T-6295.7
BASO%
Dose Level : 0
Dosage Unit: mg/kg/day
6.6 2.1 4.0 .4 .0 0 32 61 6 0 0
9.2 3.3 4.7 1.0
.1
1 36 52 11
1
1
6.7 3.1 3.1 .4 .2 0 46 46 5 2 0
9.0 5.1 3.0 .8 .0 1 56 34 9 0 1
11.3 5.4 5.3 .5 .1 0 48 47 5 1 0
8.9 4.4 3.7
.7 .1
0 49 41
8
1
0
8.6 1.76
6
3.9 1.28
6
Dose Level : 0 .03
4.0 .6 .1 .90 .24 .08 666
Dosage Unit: mg/kg/day
0 44 47 7 1 0 05 8.9 9.2 2.4 .8 .5 666666
11.7 11.5
9.5 11.1
7.2 3.2 4.0 6.3
11.0 1.00 4
5.2 1.88
4
Dose Level : 0 .15
4.0 .4 6.2 1.5 4.4 .9 4.0 .6
.2 .5 .1 .2
4.6 .8 .2 1.05 .48 .17
444
Dosage Unit: mg/kg/day
0 62 34 3 2 0 0 28 54 13 4 0 0 42 47 10 1 0 0 56 36 6 2 0
0 47 43 8 2 0
00 15.2 9.4 4.4 1.3
.0
444444
12.5 9.4 2.4
.6 .1
.0 75 19
5
1
0
11.1 5.8 4.2 1.0 .1 .0 52 38 9 1 0
10.7 4.8 4.6 1.3 .0 .0 45 43 12 0 0
15.0 9.8 3.7 .8 .6 .0 66 25 5 4 0
9.4 4.2 4.0 1.1 .0 .1 45 42 12 0 1
12.7 5.3 5.9 .8 .7 .0 42 46 6 5 0
11.9 6.6 4.1 .9 .2 .0 54 36 8 2 0
1.95
2.42
1.14
.25
.31
.04
13.4
10.9
3.3
2.1
.4
6 66 6 666 6 66 6
003144
507
ANIMAL NUMBER
Group: 4
105506 105507 105509 105511 105512 105522
MEAN S.D. N
WBC X10 /*<L
Appendix 4
Individual Clinical Hematology Data
Males
Day -27
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
N-SEG
LYMPH
XIOVidj XIOVaL
MONO
EOSIN
XIOV^L X103/h L
BASO
N-SEG%
X10V*<L
LYMPHS
MONO
EOSIN
Covance 6329-223 3M T-6295.7
BASO
Dose Level : 0.75
Dosage Uni t : mg/kg/day
9.3 3.0 5.0 1.1 .2 .1 32 54 12 2 1 13.7 4.9 6.3 2.1 .1 .2 36 46 15 1 2
7.5 3.3 2.8 .7 .7 .0 44 37 9 9 0 8.0 3.9 3.3 .6 .1 .0 49 41 8 1 0
7.1 1.6 4.3 1.2 .0 .0 22 60 16 0 1 11.0 5.5 4.1 1.1 .2 .1 50 37 10 2 1
9.4 3.7 4.3 1.1 .2 .1 39 46 12 2 1
2.53
1.40
1.25
.53
.25
.08 10.9
9.5
3.3
3.3
66666666666
003145
508
Appendix 4
Individual Clinical Hematology Data
Males
Day -27
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
ANIMAL NUMBER
ANISO
POLY
POIK
HYPO
TOXNEUT
Group: 1 Dose Level: 0
Dosage Unit: mg/kg/day
105508
_
_
_
_
105517
-
--
-
-
105519
-
--
--
105520
-
-
-
-
-
105526
-
-
-
-
-
105527
-
---
Group: 2 Dose Level: 0.03
Dosage Unit: mg/kg/day
105514
-
_
-
105515
-
-
-
--
105516
-
-
--
-
105521
-
-
-
"
-
Group: 3 Dose Level: 0.15
Dosage Unit: mg/kg/day
105505
_
_
_
105510
-
-
-
-
-
105518
-
-
-
-
-
105523
-
-
-
-
-
105524
-
-
-
-
-
105528
-
-
-
"
-
Group: 4 Dose Level: 0.75
Dosage Unit: mg/kg/day
105506
_
_
_
_
105507
-
-
-
-
-
105509
-
-
-
-
105511
-
-
-
-
_
105512
-
-
-
-
-
105522
-
-
-
-
-
Covance 6329-223 3H T-6295.7
003146
509
ANIMAL NUMBER
Group: 1
105529 105530 105531 105535 105544 105549
MEAN S.D. N
Group: 2
105537 105541 105547 105550
MEAN S.D. N
Group: 3
105532 105538 105539 105545 105548 105552
MEAN S.D. N
Appendix 4
Individual Clinical Hematology Data
Females
Day -27
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
RBC HGB ' HCT MCV MCH MCHC PLT RETIC
XlOVi^L
G/DL
%
FL
PG
%
XIOVm D
%
Covance 6329-223 3M T-6295.7
RETIC X10 /m l
Dose Level : 0
5.96 6.78 5.72 6.66 4.98 6.45
11.5 13.3 10.5 12.2
11.6 12.6
6.09 .681 6
12.0 .97 6
Dose Level: 0.03
6.13 5.78 6.30 7.02
10.6 12.0 10.7 12.8
6.31 .522
4
11.5 1.06 4
Dose Level : 0.15
6.95 6.16
6.23 6.72
6.76 6.39
12.7 11.3 11.7 12.3 11.8 12.0
6.54 .320 6
12.0 .49 6
Dosage Unit: mg/kg/day
37.1 45.0 34.7 40.8 36.2 41.9
62.2 66.4 60.6 61.3 72.7 65.0
19.3 19.6 18.3 18.3
23.2 19.5
39.3 3.93 6
64.7 4.51 6
19.7 1.81 6
Dosage Unit: mg/kg/day
36.7 40.0 37.4 43.9
59.9 69.1 59.3 62.5
17.3 20.8 17.0 18.2
39.5 3.26 4
62.7 4.49 4
18.3 1.73 4
Dosage Unit: mg/kg/day
43.2 38.3 39.2 40.7
38.0 41.1
62.2 62.1 62.9 60.6 56.2 64.2
18.2 18.4
18.8 18.3 17.4 18.7
40.1 1.97 6
61.4
2.79 6
18.3 .50 6
31.0 29.5 30.2 29.9 31.9 30.1
30.4 .87 6
28.8 30.2 28.6 29.1
29.2 .71 4
29.3 29.6 29.9 30.1 31.0 29.1
29.8 .68 6
631 552 584 577 471 417
539 79.5 6
.4 .3 .1 .5 1.3 1.0
.6 .46
6
529 426 558 414
482 72.4 4
.3 .9 .4 .2
.4 .31 4
433 475 477 325 615 560
481 100.9
6
.4 .3 .8 .1 .4 .7
.4 .26
6
24 20
6 33 65 64
35 24.2
6
18 52 25 14
27 17.1
4
28 18 50
7 27 45
29 16.2
6
frTCOQ
510
ANIMAL NUMBER
Group : 4
105533 105534 105536 105540 105542 105551
MEAN S.D. N
Appendix 4
Individual Clinical Hematology Data
Females
Day -27
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
RBC HGB HCT MCV MCH MCHC PLT RETIC
XIOV/^L
G/DL
%
FL
PG
%
X103/m L
Covance 6329-223 3M T-6295.7
RETIC X I O V aL
Dose Level : 0.75
6.46 6.72 6.67 6.21 6.57
6.35
12.1
13.1 12.1 11.8 12.0 11.7
6.50 .195 6
12.1 .50 6
Dosage Unit: mg/kg/day
41.2 44.2 41.7 39.6 42.4 40.0
63.8 65.8 62.6 63.8
64.5 63.0
18.7
19.5 18.2 19.0 18.2 18.5
41.5 1.68 6
63.9 1.14
6
18.7 .50 6
29.3 29.6 29.1 29.8 28.3 29.4
29.2 .52 6
337 438 606 433 492 304
435 108.9
6
.2 .4 .1 .0 .4 .4
.2 .18
6
13 27
7 0 26 25
16 11.4
6
003148
511
ANIMAL NUMBER
WBC X I O V aL
Appendix 4
Individual Clinical Hematology Data
Females
Day -27
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
N-SEG
LYMPH
X I O V m L x i o '/m l
'MONO xioV ml
EOSIN xioViiL
BASO
N -SEG%
xioyub
LYMPH%
MONO
EOSIN
Covance 6329-223 3M T-6295.7
O O OOMMOO
I O O M O
Group: 1 Dose Level : 0
Dosage Unit: mg/kg/day
105529
7.4 3.4 3.3 .6 .2 .0 45 45 8 2
105530 11.7 6.0 4.9 .7 .1 .0 51 42 6 1
105531
8.4 5.0 2.6 .7 .1 .1 59 31 8 1
105535 12.6 5.0 6.0 .8 .6 .1 39 48 7 5
105544 13.0 5.3 5.8 1.2 .7 .0 40 44 9 6
105549
8.0 3.1 4.3 .5 .1 .0 38 54 6 2
MEAN S.D. N
10.2 4.6 4.5 .8 .3 .0 45 44 7 3
2.52
1.14
1.36
.24
.28
.05
8. 3 7..6 1. 2 2..1
6666666666
Group: 2 Dose Level : 0 .03
Dosage Unit: mg/kg/day
105537 105541 105547 105550
12.2 8.6 2.7 .6 .2 .0 70 22
5
8.1 3.0 4.1 .9 .1 .1 36 50 11
6.8 3.6 2.5 .6 .1 .0 53 36
9
7.6 4.6 2.4 .5 .1 .0 60 32
6
2 1 2 1
MEAN S.D. N
8.7 5.0 2.9 .6 .1 .0 55 35 8 2
2.41
2.52
.79
.17
.05
.05
14.,3
11..6
2..8
6
4444444444
Group: 3 Dose Level : 0 .15
Dosage Unit: mg/kg/day
105532 105538 105539 105545 105548 105552
7.6 2.6 3.6 1.2 .2 .0 35 48 15
12.0 7.4 3.7 .7 .2 .0 62 31
6
7.1 2.6 3.5 .9 .2 .0 36 49 12
14.4 9.4 4.2 .7 .0 .0 65 29
5
11.3 5.4 4.4 .8 .7 .0 48 39
7
8.0 3.3 3.4 .7 .6 .1 41 42
9
2 2 2 0 6 8
MEAN S.D, N
10.1 5.1 3.8 .8 .3 .0 48 40 9 3
2.94
2.81
.40
,20
.27
.04 13. 0 8. 4 3. 8 3. 0
6666666666
-OOOOO
003149
512
ANIMAL NUMBER
Group: 4
105533 105534 105536 105540 105542 105551
MEAN S.D. N
WBC XlOV^iL
Appendix 4
Individual Clinical Hematology Data
Females
Day -27
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
N-SEG
LYMPH `MONO
EOS IN
X103/m L xioV/zL X103/aL XIOV^L
BASQ
N-SEG%
XIOV^L
LYMPH%
MONO%
EOSIN%
Covance 6329-223 3M T-6295.7
BASO%
Dose Level : 0.75
Dosage Unit: mg/kg/day
10.0 4.1 5.1 .7 .0 .0 41 51 7 0 0 13.3 6.9 5.2 .7 .4 .0 52 39 6 3 0
9.6 4.4 3.5 1.3 .3 .1 46 36 14 3 1 8.9 5.4 2.4 .9 .1 .0 61 27 10 1 0
8.3 5.9 2.0 .4 .0 .0 71 24 4 0 0
3.8 2.0 1.2 .5 .0 .0 53 32 14 1 0
9.0 4.8 3.2 .8 .1 .0 54 35 9 1 0
3.08
1.70
1.66
.32
.18
.04
10.7
9.7
4.2
1.4
6666 666666 6
OSTCOO
513
Appendix 4
Individual Clinical Hematology Data
Females
Day -27
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
ANIMAL NUMBER
ANISO
POLY
POIK
HYPO
TOXNEUT
Group: 1
105529 105530 105531 105535 105544 105549
Group: 2
105537 105541 105547 105550
Group: 3
105532 105538 105539 105545 105548 105552
Group: 4
105533 105534 105536 105540 105542 105551
Dose Level: 0 Dose Level: 0.03 Dose Level: 0.15 Dose Level: 0.75
Dosage Unit: mg/kg/day Dosage Unit: mg/kg/day Dosage Unit: mg/kg/day Dosage Unit: mg/kg/day
Covance 6329-223 3M T-6295.7
003151
514
ANIMAL NUMBER
Group: 1
I0550B 105517 105519 105520 105526 105527
MEAN S.D. N
Group: 2
105514 105515 105516 105521
MEAN S.D. N
Group: 3
105505 105510 105518 105523 105524 105528
MEAN S.D. N
Appendix 4
Individual Clinical Hematology Data
Males
Day 37
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
RBC HGB HCT MCV MCH MCHC PLT RETIC
XlOV/iL
G/DL
t
FL
PG
%
x i o 3/a<l
Covance 6329-223 3M T-6295.7
RETIC XlOVAiL
Dose Level: 0
6.53 6.32 6.83 6.50
6.20 6.34
13.0 13.0 12.2 12.1
11.6 12.2
6.45 .221 6
12.4 .55 6
Dose Level : 0.03
7.32 6.51 6.35 7.26
13.0 12.5 12.2 12.2
6.86 .501 4
12.5 .38 4
Dose Level : 0.15
6.34
6.99 7.20 6.78 6.31 6.34
12.8 12.3 12.7
12.6 12.3 12.1
6.66 .385 6
12.5 .27 6
Dosage Unit: mg/kg/day
41.4 42.7 40.9 39.5 38.6 40.6
63.4 67.5 59.8 60.7
62.3 64.0
19.9 20.5 17.8 18.6 18.7 19.3
40.6 1.44 6
63.0 2.74
6
19.1 .97
6
Dosage Unit: mg/kg/day
47.9 42.5 39.0 40.3
65.5 65.2 61.4 55.6
17.8 19.2 19.2 16.8
42.4 3.93 4
61.9 4.61 4
18.2 1.17
4
Dosage Unit: mg/kg/day
41.3 41.5 42.1 41.3 41.4
39.8
65.1 59.3 58.5 60.9 65.6 62.7
20.3 17.6 17.7 18.5 19.5 19.1
41.2 .76 6
62.0 2.96 6
18.8 1.06 6
31.4 30.4 29.8 30.7 30.0 30.1
30.4 .58 6
27.2 29.4 31.2 30.1
29.5 1.69 4
31.1 29.7 30.2 30.5 29.7 30.4
30.3 .53 6
369 443 474 644 375 614
486 117.8
6
492 629 344 665
532 146.1
4
421 483 498 544 519 388
476 59.6 6
.1 .2 .3 .1 .1 .5
.2 .16
6
.6 .8 .3 .0
.4 .35
4
.3 .4 .6 .4 .2 .3
.4 .14 6
7 13 20
6 6 32
14 10.4
6
44 52 19
0
29 23.8
4
19 28 43 27 13 19
25 10.5
6
003152
515
ANIMAL NUMBER
Appendix 4
Individual Clinical Hematology Data
Males
Day 37
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
RBC HGB HCT MCV MCH MCHC PLT RETIC
X106/m L
G/DL
%
FL
PG
%
XIOV^L
%
Covance 6329-223 3M T-6295.7
RETIC XIOV^L
Group: 4
105506 105507 105509 105511 105512 105522
MEAN S.D. N
Dose Level : 0.75
7.03 6.57 6.84 5.80
6.60 6.32
12.3 11.4 12.1 10.9 12.1 12.3
6.53 .431 6
11.8 .57 6
Dosage Unit: mg/kg/day
41.0 39.6 41.9 37.1
40.3 41.5
58.3 60.2 61.3 63.9 61.0 65.6
17.4 17.3 17.6 18.8 18.3 19.4
40.2 1.74 6
61.7 2.63 6
18.1 .85 6
29.9 28.7 28.8 29.5 30.1 29.6
29.4 .57 6
459 69 PA
399 490 362 519
383 164.3
6
.3 .3 .3 .4 .5 .5
.4 .10
6
21 20 21 23 33 32
25 5.! 6
stc o o
516
ANIMAL NUMBER
Group : 1
105508 105517 105519 105520 105526 105527
MEAN S.D. N
Group: 2
105514 105515 105516 105521
MEAN S.D. N
Group : 3
105505 105510 105518 105523 105524 105528
MEAN S.D. N
WBC XIOVm L
Appendix 4
Individual Clinical Hematology Data
Males
Day 37
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
N-SEG
LYMPH
XIO V m L X10 /m l
MONO xioV ml
EOSIN xioV ml
BASO
N -SEG%
XIOVm L
LYMPH%
MONO%
EOSIN%
Covance 6329-223 3M T-6295.7
BASO%
Dose Level : 0
Dosage Unit: mg/kg/day
5.2 1.8 2.9 .4 .0 .0 34 57 9 1 0
7.8 2.5 4.2 .9 .0 .2 32 53 12 0 2 7.1 3.5 3.4 .2 .1 .0 49 48 3 1 0 6.8 3.5 2.9 .4 .0 .0 52 43 5 0 0 7.5 4.7 2.2 .3 .2 .0 63 30 4 3 0 11.2 7.5 2.8 .9 .0 .0 67 25 8 0 0
7.6 3.9 3.1 .5 .0 .0 50 43 7 1 0
1.98
2.01
.67
.31
.08
.08
14. 4
12. 8
3..4
1. 2
8
66666666666
Dose Level : 0 .03
Dosage Unit: mg/kg/day
11.9 5.9 5.3 .5 .2 .0 50 44 4 2 0 8.0 3.1 4.1 .6 .2 .0 39 51 7 2 0
12.1 8.2 3.1 .7 .2 .0 67 25 5 2 0 11.0 8.1 2.4 .3 .1 .0 74 22 3 1 0
10.8 6.3 3.7 .5 .2 .0 58 36 5 2 0
1.89
2.40
1.26
.17
.05
.00
15. 9
14. 2
1,.7
.5
.0
44444444444
Dose Level : 0 .15
Dosage Unit: mg/kg/day
11.7 9.3 2.0 .2 .3 .0 79 17 2 2 0 8.8 5.1 2.9 .7 .0 .0 58 32 8 1 0 9.4 3.9 4.6 .8 .0 .0 42 49 8 0 0
11.1 7.0 3.6 .4 .1 .0 63 32 4 1 0 6.9 3.5 2.6 .8 .0 .1 50 37 12 0 1
12.4 7.2 3.6 .7 .8 .1 58 30 5 6 0
10.0 6.0 3.2 .6 .2 .0 58 33 6 2 0
2.06
2.23
.91
.24
.32
.05
12. 5
10. 4
3. 6
2. 3
4
66666666666
003154
517
ANIMAL NUMBER
Group : 4
105506 105507 105509 105511 105512 105522
MEAN S.D. N
WBC X103/m L
Appendix 4
Individual Clinical Hematology Data
Males
Day 37
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
N-SEG
LYMPH
X103/*tL X103/#iL
MONO
EOS IN
X103/m L XIOVwL
BASO
N-SEG%
X103/^L
LYMPH%
MONO%
EOSIN%
Covance 6329-223 3M T-6295.7
BASO%
Dose Level : 0.75
Dosage Unit: mg/kg/day
7.1 3.4 2.9 .7 .1 .0 48 41 9 1 1
17.9
13.3
3.8 .7
.1
.1
74
21
4
0
1
11.6 8.0 2.8 .4 .3 .0 69 24 4 3 0
8.5 5.5 2.4 .5 .1 .1 65 28 6 1 1
6.6 3.5 2.4 .7 .0 .0 53 36 10 0 1
10.2 6.2 3.0 .9 .0 .1 61 30 9 0 1
10.3 6.6 2.9 .6 .1 .0 62 30 7 1 1
4.16
3.69
.52
.18
.11
.05
9.8 7.5 2.7 1.2
66666666666
SSTOO
518
Appendix 4
Individual Clinical Hematology Data
Males
Day 37
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
ANIMAL NUMBER
ANISO
POLY
POIK
HYPO
TOXNEUT
Group: 1
105508 105517 105519 105520 105526 105527
Group: 2
105514 105515 105516 105521
Group: 3
105505 105510 105518 105523 105524 105528
Group: 4
105506 105507 105509 105511 105512 105522
Dose Level: 0
_
--
--
---
--
Dose Level: 0.0:
__
--
--
--
Dose Level: 0.1!
__
--
----
-
Dose Level: 0.7!
__
--
----
--
Dosage Unit: mg/kg/day Dosage Unit: mg/kg/day Dosage Unit: mg/kg/day Dosage Unit: mg/kg/day
Covance 6329-223 3M T-6295.7
003156
519
ANIMAL NUMBER
Appendix 4
Individual Clinical Hematology Data
Females
Day 37
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
RBC HGB HCT MCV MCH MCHC PLT RETIC
X106//<L
G/DL
%
FL
PG
%
xioV ml
%
Covance 6329-223 3M T-6295.7
RETIC XIOV^L
Group: 1
105529 105530 105531 105535 105544 105549
MEAN S.D. N
Group: 2
105537 105541 105547 105550
MEAN S.D. N
Group: 3
105532 105538 105539 105545 105548 105552
MEAN S.D. N
Dose Level: 0
6.43 6.51 6.37 6.52 5.78 6.85
12.3 12.7 11.6 11.8
11.6 13.3
6.41 .351 6
12.2 .69 6
Dose Level : 0.03
6.60 5.70 6.79 7.29
10.9 11.7
11.6 13.2
6.60 .664 4
11.8 .97 4
Dose Level : 0.15
6.43 6.40
6.35 6.85 7.09 6.19
11.9 11.3 12.0 12.4 11.9 11.4
6.55 .343 6
11.8 .41 6
Dosage Unit: mg/kg/day
40.4 42.1 38.8 39.1
37.9 44.4
62.8 64.7
60.8 60.0
65.6 64.8
19.1 19.6 18.1 18.0 20.0 19.5
40.5 2.42 6
63.1 2.31 6
19.0 .83 6
Dosage Unit: mg/kg/day
38.1 40.5 39.0 44.7
57.8 70.9 57.4 61.3
16.6 20.6 17.0 18.1
40.6 2.92 4
61.8 6.28 4
18.1 1.80 4
Dosage Unit: mg/kg/day
39.5 38.4
40.6 41.2 39.8 38.8
61.3 60.1
63.8 60.1 56.1 62.7
18.5 17.7
18.9 18.1 16.8 18.5
39.7 1.06 6
60.7 2.68 6
18.1 .75 6
30.5 30.2 29.8 30.0 30.5 30.0
30.2 .29 6
28.7 29.0 29.7 29.6
29.2 .48 4
30.1 29.5 29.5 30.1 29.8 29.5
29.7 .29 6
647 629 439 538 499 475
538 84.2 6
448 391 417 411
417 23.6 4
451 398 406 300 553 478
431 85.3 6
.3 .5 .2 .1 .4 .5
.3 .16
6
.3 .7 .1 .1
.3 .28 4
.4 .4 .1 .3 .3 .2
.3 .12
6
19 33 13
7 23 34
22 10.8
6
20 40
7 7
18 15.6
4
26 26
6 21 21 12
19 8.0 6
003157
520
ANIMAL NUMBER
Group: 4
105533 105534 105536 105540 105542 105551
MEAN S.D. N
Appendix 4
Individual Clinical Hematology Data
Females
Day 37
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
RBC HGB HCT MCV MCH MCHC PLT RETIC
X106/m L
G/DL
FL
PG
XlOV^iL
Covance 6329-223 3M T-6295.7
RETIC xioV m
Dose Level: 0.75
6.04 5.91 6.43 6.09 6.66 6.12
11.6 11.3 11.7 11.4 12.2
11.1
6.21 .280 6
11.6 .38 6
Dosage Unit : mg/kg/day
38.0 38.4
41.3 37.1 41.8 37.9
62.8 65.0 64.2 60.9
62.8 62.0
19.1 19.2
18.3 18.7
18.3 18.2
39.1 1.96 6
63.0 1.48 6
18.6 .44
6
30.5 29.5 28.4 30.8 29.2 29.3
29.6 .89 6
345 532 531 501 555 351
469 95.4 6
.3 .7 .2 .1 .2 .5
.3 .23
6
18 41 13
6 13 31
20 13.1
6
003158
521
animal
NUMBER
Group: 1
105529 105530 105531 105535 105544 105549
MEAN S.D. N
Group : 2
105537 105541 105547 105550
MEAN S.D. N
Group: 3
105532 105538 105539 105545 105548 105552
MEAN S.D. N
WBC XIOVm L
Appendix 4
Individual Clinical Hematology Data
Females
Day 37
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
N-SEG
LYMPH
XIOV^L x i o 3/m l
MONO
EOSIN
XIOV/ZL XIOViiL
BASO
N -SEG%
XlOV/aL
LYMPH%
MONO*
EOSIN%
Covance 6329-223 3M T-6295.7
BASO%
Dose Level: 0
Dosage Unit: mg/kg/day
9.6 6.2 2.8 .5 .1 .0 65 30 5 1 0
12.1 8.3 2.8 1.0 .0 .0 68 23 8 0 0
14.6
11.7
1.9
.9
.1
.1 80
13
6
1
0
21.4
12.2
5.9
2.4
.7
.2 57
28
11
3
1
8.6 2.3 5.2 .7 .3 .0 26 61 8 4 1
10.1 5.9 2.8 1.0 .4 .0 58 28 10 4 0
12.7 4.75 6
7.8 3.77
6
Dose Level : 0.03
3.6 1.59
6
1.1 .67
6
.3 .26
6
Dosage Unit: mg/kg/day
.0 59 30 8 2 0
.08
18.2
16. 2
2.,3
1..7
.5
666666
7.7 3.5 2.8 .8 .5 .1 46 36 10 6 2 11.5 6.5 3.7 1.1 .2 .0 56 32 10 2 0
7.3 5.0 1.7 .5 .1 .0 68 24 7 1 0 11.7 7.9 2.8 .8 .2 .0 68 24 6 2 0
9.6 5.7 2.8 .8 .2 .0 60 29 8 3 0
2.37
1.90
.82
.24
.17
.05
10.6
6.,0 2. 1 2. 2 1, 0
44444444444
Dose Level : 0.15
Dosage Unit: mg/kg/day
8.0 5.4 2.0 .4 .1 .0 68 25 5 2 0 9.4 5.1 3.4 .6 .3 .0 54 36 6 3 0 4.4 1.2 2.8 .4 .1 .0 26 63 8 2 0 10.0 5.2 3.9 .7 .1 .0 52 39 7 1 0 11.7 7.7 3.0 .5 .4 .0 66 26 4 4 0 11.2 8.2 2.2 .4 .5 .0 73 19 4 4 0
9.1 5.5 2.9 .5 .2 .0 56 35 6 3 0
2.66
2.48
.72
.13
.18
.00
17.0
15. 7
1. 6
1. 2
0
66666666666
6STD00
522
ANIMAL NUMBER
Group : 4
105533 105534 105536 105540 105542 105551
MEAN S.D. N
WBC XloVrtL
Appendix 4
Individual Clinical Hematology Data
Females
Day 37
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
N-SEG
LYMPH
XIOVm L XIOVaL
MONO
EOSIN
XlOVnL XIOVm L
BASO
N-SEG%
X10///L
LYMPH%
MONO
EOSIN
Covance 6329-223 3M T-6295.7
BASO
Dose Level : 0.75
Dosage Unit: mg/kg/day
8.8 3.9 4.4 .4 .0 .0 45 50 5 0 0
8.8 4.6 3.0 .9 .2 .0 52 34 11 3 1
7.6 4.8 2.0 .6 .1 .0 63 27 8 2 0
9.7 5.0 3.9 .6 .1 .0 51 40 7 1 0
13.7
11.5
1.8
.4
.0
.0 84
13
3
0
0
5.0 2.2 2.3 .4 .1 .0 44 47 7 2 0
8.9 5.3 2.9 .6 .1 .0 56 35 7 1 0
2.85
3.19
1.06
.20
.08
.00
15.1
13.7
2.7
1.2
66666666666
003160
523
Appendix 4
Individual Clinical Hematology Data
Females
Day 37
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
ANIMAL NUMBER
ANISO
POLY
POIK
HYPO
TOXNEUT
Group: 1
105529 105530 105531 105535 105544 105549
Dose Level: 0
___ ___ ___ ___ ___
Group: 2
105537 105541 105547 105550
Dose Level: 0.03
___ ___ ___ ___
Group: 3
105532 105538 105539 105545 105548 105552
Dose Level: 0.15
___ ___ ___ ___ ___
Group: 4
105533 105534 105536 105540 105542 105551
Dose Level: 0.75
--___ ___ -
Dosage Unit: mg/kg/day
__ __
__ __ __
Dosage Unit: mg/kg/day
__ __ __ __
Dosage Unit: mg/kg/day
__
__ __ __ __
Dosage Unit: mg/kg/day
-__ __
Covance 6329-223 3M T-6295.7
T9TC00
524
ANIMAL NUMBER
Group: 1
105508 105517 105519 105520 105526 105527
MEAN S.D. N
Group: 2
105514 105515 105516 105521
MEAN S.D. N
Group: 3
105505 105510 105518 105523 105524 105528
MEAN S.D. N
Appendix 4
Individual Clinical Hematology Data
Males
Day 62
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
RBC HGB HCT MCV MCH MCHC PLT RETIC
XIOVliL
G/DL
%
FL
PG
%
X103/#/L
%
Covance 6329-223 3M T-6295.7
RETIC XlOV/iL
Dose Level : 0
6.68 6.29 6.93 6.53 6.10 6.43
13.2 12.9 12.2 12.4 11.7
12.5
6.49 .292 6
12.5 .53 6
Dose Level: 0.03
6.86 6.61 6.44 7.44
12.2 12.6
12.0 12.7
6.84 .437 4
12.4 .33 4
Dose Level : 0.15
6.47 6.82 7.10 6.51 6.54 6.19
13.0 12.4 12.7 12.7 12.6 11.5
6.60 .315 6
12.5 .52 6
Dosage Unit: mg/kg/day
42.0 42.8 41.6 39.9 38.1 42.3
62.8 68.0 59.9 61.1 62.4 65.8
19.8 20.4
17.6 18.9
19.1 19.4
41.1 1.78 6
63.3 3.03 6
19.2 .95 6
Dosage Unit : mg/kg/day
41.7 42.3 39.4 42.2
60.9 63.9 61.1 56.8
17.7 19.1 18.7 17.1
41.4 1.36 4
60.7 2.92 4
18.2 .91 4
Dosage Unit: mg/kg/day
41.6 40.1
41.5 40.9 42.1 38.2
64.2 58.8 58.5 62.8 64.3 61.8
20.1 18.2
17.8 19.5 19.3 18.6
40.7 1.42 6
61.7 2.56 6
18.9 .87 6
31.5 30.1 29.4 31.0 30.7 29.5
30.4 .84 6
29.1 29.9 30.6 30.0
29.9 .62 4
31.3 30.9 30.5 31.0 30.0 30.2
30.6 .50 6
463 423 524 699 377 644
522 126.9
6
.1 .5 .3 .0 .1 .7
.3 .27
6
438 647 376 684
536 152.1
4
.1 1.0
.4 .0
.4 .45 4
450 499 578 625 520 349
504 97.3 6
.5 .5 .6 .1 .0 .2
.3 .25 6
7 31 21
0 6 45
18 17.3
6
7 66 26
0
25 29.6
4
32 34 43
7 0 12
21 17.3
6
Z9TC00
525
ANIMAL NUMBER
Appendix 4
Individual Clinical Hematology Data
Males
Day 62
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
RBC HGB HCT MCV MCH MCHC PLT RETIC
XIOViiL
G/DL
%
FL
PG
%
xioVnL
%
Covance 6329-223 3M T-6295.7
RETIC XIOV/iL
Group: 4
105506 105507 105509 105511 105512 105522
MEAN S.D. N
Dose Level : 0.75
7.46 6.81
6.69 5.86 6.90 6.65
13.1 12.1
11.9 11.1
12.8 12.8
6.73 .516 6
12.3 .75 6
Dosage Unit: mg/kg/day
43.4 40.5 40.0 37.6 41.6 43.8
58.2 59.4 59.8 64.1
60.3 65.9
17.6 17.7 17.7 18.9 18.5 19.3
41.2 2.31 6
61.3 3.02
6
18.3 .72 6
30.2 29.8 29.6 29.5 30.7 29.3
29.8 .52 6
534 36
480 629 359 586
437 217.8
6
.3 .1 .5 .4 .0 .4
.3 .19 6
22 7
33 23
0 27
19 12.6
6
C9TOO
526
ANIMAL NUMBER
Group: 1
105508 105517 105519 105520 105526 105527
MEAN S.D. N
Group: 2
105514 105515 105516 105521
MEAN S.D. N
Group : 3
105505 105510 105518 105523 105524 105528
MEAN S.D. N
WBC XlOV^L
Appendix 4
Individual Clinical Hematology Data
Males
Day 62
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
N-SEG
LYMPH
x i o V m l X103/m L
MONO
EOS IN
X10 /m l XIOV/iL
BASO
N-SEG%
xioV ml
LYMPH%
MONO%
EOSIN%
Covance 6329-223 3M T-6295.7
BASO%
Dose Level : 0
7.4 3.7 8.0 2.1 6.7 3.1 8.0 3.8 6.0 3.2 7.8 2.4
7.3 .81 6
3.0 .68 6
Dose Level : 0 .03
8.1 10.3 12.1 11.6
5.0 4.6
7.3 7.5
10.5 1.79
4
6.1 1.51
4
Dose Level : 0 .15
10.8 13.3
9.9 12.7
7.7 16.4
8.0 8.7 3.2 7.7 3.2
11.1
11.8 3.02 6
7.0 3.16
6
Dosage Unit: mg/kg/day
3.3 .4 4.7 1.0 3.2 .4 3.4 .6 2.2 .5 4.2 .9
.0 .1
.0 .1 .1 .2
3.5 .6 .1 .87 .26 .08 666
Dosage Unit: mg/kg/day
2.3 .5 4.3 1.2 3.5 1.1 3.4 .5
.2 .2 .1 .2
3.4 .8 .2 .82 .38 .05 444
Dosage Unit: mg/kg/day
2.3 .2 3.7 .7
5.8 .8 4.5 .4 3.4 1.0
3.6 1.3
.3 .1 .1 .1 .1 .4
3.9 .7 .2
1.18 .40 .13 666
.0 49 45 5 1 0 .1 27 59 12 1 2 .0 46 48 5 1 0 .1 48 43 7 1 1 .0 52 36 9 2 0 .0 31 54 12 3 0
.0 42 48 8 2 0 .05 10. 5 8. 2 3..2 .8 .8
66 666 6
.0 62 29 6 2 0 .0 44 42 12 2 0 .0 61 29 9 1 0 .0 65 29 4 2 0
.0 58 32 8 2 0 .00 9. 5 6.,5 3.,5 .5 .0 444444
.0 73 21 2 3 0 .0 65 28 6 1 0
.0 32 59 8 1 0 .0 60 36 3 1 0 .1 41 44 13 1 1
.1 68 22 8 2 0
.0 56 35 7 2 0
.05
16. 3
14. 6
4. 0
8 .4
66 666 6
003164
527
ANIMAL NUMBER
Group: 4
105506 105507 105509 105511 105512 105522
MEAN S.D. N
WBC XloVnL
Appendix 4
Individual Clinical Hematology Data
Males
Day 62
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
N-SEG
LYMPH
xioVnt XIOV^L
MONO
EOS IN
XIOVm L XIOVnL
BASO
N-SEG%
X10V//L
LYMPH%
MONO%
EOSIN%
Covance 6329-223 3H T-6295.7
BASO%
Dose Level : 0.75
Dosage Unit: mg/kg/day
6.5 2.5 3.5 .4 .1 .0 38 54 6 1 0 14.6 9.6 3.6 1.0 .2 .2 66 24 7 2 1 10.6 6.4 2.8 .7 .6 .1 60 27 7 6 1
7.7 4.2 3.0 .4 .1 .0 54 39 5 1 0
7.7 3.6 3.5 .6 .0 .0 46 45 8 0 0 10.7 5.5 4.3 .7 .2 .0 51 40 6 2 0
9.6 5.3 3.4 .6 .2 .0 52 38 6 2 0
2.97
2.52
.52
.23
.21
.08
10.0
11.2
1.0
2.1
666 6666 6 6 6 6
9T00
528
Appendix 4
Individual Clinical Hematology Data
Males
Day 62
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
ANIMAL NUMBER
ANISO
POLY
POIK
HYPO
TOXNEUT
Group: 1 Dose Level : 0
Dosage Unit: mg/kg/day
105508
_
_
_
105517
-
-
-
105519
-
-
-
105520
-
-
-
105526
-
-
-
105527
-
_-
---
--
--
"-
Group: 2 Dose Level: 0.03
Dosage Unit: mg/kg/day
105514 105515 105516
105521
_ -
-
_ -
___
---
- -*--
Group: 3 Dose Level : 0.15
Dosage Unit: mg/kg/day
105505
-
-
_
_
_
105510
-
--
-
-
105518
-
-
-
-
-
105523
-
-
-
-
-
105524
-
-
-
-
-
105528
-
-*-
Group: 4
105506 105507 105509 105511 105512 105522
Dose Level: 0.75
__ ------
-
Dosage Unit: mg/kg/day
_
-_ -----
Covance 6329-223 3M T-6295.7
0031G 6
529
ANIMAL NUMBER
Group: 1
105529 105530 105531 105535 105544 105549
MEAN S.D. N
Group : 2
105537 105541 105547 105550
MEAN S.D. N
Group : 3
105532 105538 105539 105545 105548 105552
MEAN S.D. N
Appendix 4
Individual Clinical Hematology Data
Females
Day 62
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
RBC HGB HCT MCV MCH MCHC PLT RETIC
xioV ml
G/DL
%
FL
PG
%
X103//iL
Covance 6329-223 3M T-6295.7
RETIC X103///L
Dose Level: 0
6.15 5.93 6.56 7.02
4.91 6.83
12.0 12.1 12.1 12.7
11.5 13.4
6.23 .766 6
12.3 .66 6
Dose Level : 0.03
6.44 5.67 6.82
7.01
10.9 12.2
11.9 12.9
6.48 .593 4
12.0 .83 4
Dose Level : 0.15
9.13 6.64 6.45 6.74 6.80 6.21
17.2 11.8 12.5 12.2 11.7 11.6
7.00 1.068
6
12.8 2.17 6
Dosage Unit: mg/kg/day
38.4 39.7
40.5 42.4
35.4 44.9
62.4 66.8 61.6 60.4 72.1 65.8
19.5 20.3 18.5 18.2
23.4 19.6
40.2 3.27
6
64.9 4.33 6
19.9 1.87 6
Dosage Unit: mg/kg/day
37.8 40.5 39.2 43.4
58.8 71.3 57.4 62.0
16.9 21.4 17.4 18.4
40.2 2.39 4
62.4 6.25 4
18.5 2.02
4
Dosage Unit: mg/kg/day
55.9 40.0 40.4 40.3 38.4 38.9
61.2 60.3 62.6 59.8 56.4 62.6
18.8 17.8 19.3 18.0 17.2 18.6
42.3 6.70 6
60.5 2.31 6
18.3 .76 6
31.3 30.4 30.0 30.0 32.4 29.8
30.6 1.01 6
28.8 30.1 30.3 29.7
29.7 .67 4
30.8 29.5 30.9 30.2 30.4 29.7
30.3 .57 6
668 515 644 600 506 501
572 74.6 6
357 507 548 437
462 83.8 4
306 456 374 326 667 486
436 133.5
6
.5 .6 .1 .3 .7 .5
.4 .22
6
.3 .7 .8 .0
.4 .37
4
.1 .6 .0 .7 .3 .5
.4 .28
6
31 36
7 21 34 34
27 11.2
6
19 40 55
0
28 24.1
4
9 40
0 47 20 31
24 18.2
6
003167
530
ANIMAL NUMBER
Appendix 4
Individual Clinical Hematology Data
Females
Day 62
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
RBC HGB HCT MCV MCH MCHC PLT RETIC
X106/m L
G/DL
%
FL
PG
%
X10V//L
%
Covance 6329-223 3M T-6295.7
RETIC XlOViiL
Group: 4
105533 105534 105536 105540 105542 105551
MEAN S.D. N
Dose Level: 0.75
6.04 5.74 6.72 6.13 6.75 6.32
11.7 11.4 12.2 11.9 12.1 11.7
6.28 .397
6
11.8 .29
6
Dosage Unit : mg/kg/day
39.0 37.9 42.6 39.5 42.6 39.5
64.6 66.0 63.5 64.5 63.0 62.5
19.3 19.8 18.2 19.4
18.0 18.6
40.2 1.96 6
64.0 1.27 6
18.9 .72 6
29.9 30.0 28.7 30.1 28.5 29.7
29.5 .70 6
355 620 622 432 665 333
504 148.3
6
.4 .5 .1 .6 .0 .1
.3 .25 6
24 29
7 37
0 6
17 14.'
6
003168
531
ANIMAL NUMBER
WBC X103//iL
Appendix 4
Individual Clinical Hematology Data
Females
Day 62
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
N-SEG
LYMPH
'MONO
EOSIN
BASO
N-SEG%
XI03/A X103/aL X10 /m l X103/*iL X10V/iL
LYMPH%
MONO%
EOSIN%
Covance 6329-223 3M T-6295.7
BASO%
Group : 1 Dose Level : 0
Dosage Unit: mg/kg/day
105529
5.8 2.9 2.2 .5 .1 .0 50 38 9 1 1
105530 13.0 7.8 4.5 .5 .1 .0 60 35 4 1 0
105531 14.1 9.9 3.0 .9 .2 .1 70 22 6 1 1
105535 10.9 3.5 5.4 1.4 .5 .2 32 49 13 5 1
105544 10.5 2.9 7.0 .0 .5 .0 27 67 0 5 0
105549 12.4 7.9 3.7 .4 .3 .0 64 30 3 2 0
MEAN S.D. N
11.1 5.8 4.3 .6 .3 .0 50 40 6 2 0
2.93
3.08
1.73
.48
.18
.08
17. 6
15,,9
4..6
2..0
.5
66666666666
Group: 2 Dose Level : 0 .03
Dosage Unit: mg/kg/day
105537 10.6 5.7 3.4 .8 .5 .1 54 33 8 5 1
105541
8.3 2.4 5.0 .6 .2 .1 29 61 8 2 1
105547
7.2 3.7 2.7 .5 .2 .0 52 38 7 2 0
105550
8.8 5.6 2.4 .7 .1 .0 63 27 8 1 0
MEAN S.D. N
8.7 4.4 3.4 .6 .2 .0 50 40 8 2 0
1.42
1.59
1.16
.13
.17
.06
14..5
14. 9
,5 1. 7
6
44444444444
Group: 3 Dose Level : 0 .15
Dosage Unit: mg/kg/day
105532
8.9 5.7 2.3 .7 .1 .0 64 26 8 1 0
105538 10.6 5.7 4.1 .4 .4 .0 54 39 4 4 0
105539
6.1 2.2 3.1 .5 .2 .1 37 51 9 3 1
105545
9.7 4.0 5.0 .5 .2 .0 41 51 5 2 0
105548
7.1 2.3 3.7 .7 .3 .1 32 52 10 5 1
105552 10.1 6.0 3.2 .3 .5 .0 60 32 3 5 0
MEAN S.D. N
8.8 4.3 3.6 .5 .3 .0 48 42 6 3 0
1.78
1.75
.93
.16
.15
.05
13. 1
11. 2
2. 9
1. 6
5
6 66 6 6 66 6 6 6 6
G9TC00
532
ANIMAL NUMBER
WBC x i o '/m l
Appendix 4
Individual Clinical Hematology Data
Females
Day 62
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
N-SEG
LYMPH
XIOV^L XlOVliL
MONO
EOSIN
X103/m L XIOV/^L
BASO
N-SEG%
XlOV^L
LYMPH%
MONO%
EOSIN%
Covance 6329-223 3M T-6295.7
BASO%
Group: 4 Dose Level : 0.75
Dosage Unit: mg/kg/day
O O iH O O O
105533
8.4 3.2 4.8 .4 .0 .0 38 57 4 0
105534
18.0
12.8
3.6
1.4
.2
.1 71 20
8
1
105536
6.7 3.9 1.8 .7 .2 .1 58 27 11
3
105540
8.1 4.5 2.9 .6 .1 .0 55 36 7 1 i
105542 10.0 6.9 2.6 .4 .1 .0 69 27 4 1 l
105551
4.8 2.1 2.3 .3 .1 .0 44 48 6 1 i
MEAN S.D, N
9.3 5.6 3.0 .6 .1 .0 56 36 7 1 l
4.59
3.89
1.07
.40
.08
.05
13.2
14.2
2.7
1.0
6 666 6 66 6 66 i
(V.TP0O
533
Appendix 4
Individual Clinical Hematology Data
Females
Day 62
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
ANIMAL NUMBER
ANISO
POLY
POIK
HYPO
TOXNEUT
Group: 1
105529 105530 105531 105535 105544 105549
Dose Level: 0
---------
Group: 2
105537 105541 105547 105550
Dose Level: 0.03
-------
Group: 3
105532 105538 105539 105545 105548 105552
Dose Level: 0.15
-------------
Group: 4
105533 105534 105536 105540 105542 105551
Dose Level: 0.75
-------------
Dosage Unit: mg/kg/day
--
--
---
Dosage Unit: mg/kg/day
--
---
Dosage Unit: mg/kg/day
-------
Dosage Unit: mg/kg/day
-------
Covance 6329-223 3M T-6295.7
003171
534
ANIMAL NUMBER
Group: 1
105508 105517 105519 105520 105526 105527
MEAN S.D. N
Group: 2
105514 105515 105516 105521
MEAN S.D. N
Group: 3
105505 105510 105518 105523 105524 105528
MEAN S.D. N
Appendix 4
Individual Clinical Hematology Data
Males
Day 91
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
RBC HGB HCT MCV MCH MCHC PLT RETIC
XIOVm L
G/DL
%
FL
PG
%
XIOV/iL
t
Covance 6329-223 3M T-6295.7
RETIC X103/*iL
Dose Level: 0
6.39 6.21 6.92 6.45 6.01 6.59
12.8 12.8 12.2 12.1
11.5 12.8
6.43 .314 6
12.4 .53 6
Dose Level: 0.03
6.96 6.71
6.43 7.88
12.3 12.8
12.2 13.4
7.00 .628
4
12.7 .55 4
Dose Level : 0.15
6.07 6.64 6.95 6.33 6.48 6.51
12.1 12.2 12.5 12.5 12.4 12.3
6.50 .295 6
12.3 .16 6
Dosage Unit: mg/kg/day
39.6 41.3 40.7 39.2 37.4 43.8
62.0 66.6 58.8 60.8
62.3 66.4
20.0 20.7
17.6 18.8 19.2 19.4
40.3 2.17 6
62.8
3.11 6
19.3 1.06 6
Dosage Unit: mg/kg/day
42.2 42.9 40.4 44.7
60.6
63.9 62.8 56.8
17.7
19.1 19.0 17.0
42.5 1.78
4
61.0 3.13 4
18.2 1.02 4
Dosage Unit: mg/kg/day
39.4 39.6 40.9 40.0 41.9 40.3
64.8 59.6 58.8 63.2 64.6 61.8
19.9 18.3 18.0 19.7 19.2 18.8
40.4 .93 6
62.1 2.53 6
19.0 .76 6
32.2 31.1 29.9 30.8 30.8 29.3
30.7 1.00 6
29.2 29.8 30.2 30.0
29.8 .43 4
30.7 30.7 30.5 31.2 29.7 30.5
30.6 .49 6
387 406 475 671 384 614
490 124.3
6
.3 .7 .1 .1 .2 .6
.3 .26
6
389 630 290 741
512 208.8
4
.3 1.0 1.3
.2
.7 .54 4
505 487 501 585 555 346
496 82.6 6
1.6 .4 .2 .4 .2 .3
.5 .54
6
19 43
7 6 12 40
21 16.4
6
21 67 84 16
47 33.7
4
97 27 14 25 13 20
33 32.0
6
000172
535
ANIMAL NUMBER
Group: 4
105506 105507 105509 105511 105512 105522
MEAN S.D. N
Appendix 4
Individual Clinical Hematology Data
Males
Day 91
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
RBC HGB HCT MCV MCH MCHC PLT RETIC
X106/*<L
G/DL
FL
PG
%
Xl03/iiL
%
Covance 6329-223 3M T-6295.7
RETIC X10V//L
Dose Level: 0.75
7.22 6.81 6.37 5.94
7.13 6.48
13.0 11.9
11.3 11.2 12.9
12.7
6.66 .488 6
12.2 .81 6
Dosage Unit: mg/kg/day
42.6 41.5
38.3 38.0
43.0 42.3
59.0 61.0 60.2 64.0 60.2 65.3
18.0 17.4 17.7 18.8 18.1
19.5
41.0 2.23 6
61.6 2.47
6
18.2 .77 6
30.5 28.6 29.4 29.4 30.0 29.9
29.6 .65 6
522 50
475 552 396 592
431 198.6
6
.3 .4 .6 .4 .1 .6
.4 .19
6
22 27 38 24
7 39
26 11.8
6
003173
536
ANIMAL NUMBER
WBC X10 /iL
Appendix 4
Individual Clinical Hematology Data
Males
Day 91
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
N-SEG
LYMPH
x i o V m l XIO V aL
MONO
EOS IN
X10V*<L XlOV^iL
BASO
N -SEG%
XIOV^L
LYMPH%
MONO%
EOSIN%
Covance 6329-223 3M T-6295.7
BASO%
Group : 1 Dose Level : 0
Dosage Unit: mg/kg/day
105508
6.1 2.3 3.2 .3 .2 .0 38 52 5 4 1
105517
7.8 2.9 4.2 .6 .1 .1 37 54 8 1 1
105519
5.8 2.5 3.0 .2 .0 .0 44 52 3 1 0
105520
5.1 1.7 2.9 .4 .1 .0 34 57 8 1 1
105526
5.1 1.7 2.8 .4 .1 .0 34 56 8 3 0
105527 10.2 3.3 6.0 .6 .2 .0 33 59 6 2 0
MEAN S.D. N
6.7 2.4 3.7 .4 .1 .0 37 55 6 2 0
1.99 .64 1.24 .16 .08 .04
4..1 2..8 2..1 1.3
.5
66666666666
Group: 2 Dose Level : 0 .03
Dosage Unit: mg/kg/day
105514
6.9 3.5 2.6 .6 .3 .0 50 38 8 4 0
105515
7.7 2.4 4.5 .6 .2 .0 31 58 8 2 0
105516 10.6 6.4 3.4 .6 .1 .0 60 32 6 1 0
105521
8.7 5.3 2.7 .6 .1 .0 61 31 7 1 0
MEAN S.D. N
8.5 4.4 3.3 .6 .2 .0 50 40 7 2 0
1.60
1.79
.88
.00
.10
.00
13.,9
12,.6
1.,0
1.4
.0
44444444444
Group: 3 Dose Level : 0 .15
Dosage Unit: mg/kg/day
105505
8.9 6.2 2.2 .3 .1 .0 70 25 4 1 0
105510 10.7 6.4 3.2 .9 .1 .1 60 30 9 1 1
105518 15.8 7.9 6.8 1.0 .1 .1 50 43 6 1 1
105523
8.6 4.3 3.7 .4 .1 .0 50 43 5 1 0
105524
6.4 2.8 2.8 .7 .0 .1 44 44 11 0 1
105528 11.4 6.8 3.4 .6 .5 .0 59 30 6 5 0
MEAN S.D.
N
10.3 5.7 3.7 .6 .2 .0 56 36 7 2 0
3.21
1.85
1.61
.27
.18
.05
9. 3 8. 4 2. 6 1.8
.5
66666666666
003174
537
ANIMAL NUMBER
Group : 4
I055Q6 105507 105509 105511 105512 105522
MEAN S.D. N
WBC xioV ml
Appendix 4
Individual Clinical Hematology Data
Males
Day 91
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
N-SEG
LYMPH
x i o V m l X10V/^L
MONO
EOSIN
x i o V m l X103/*iL
BASO
N-SEG%
X103/*L
LYMPH%
MONO%
EOSIN%
Covance 6329-223 3M T-6295.7
BASO
Dose Level : 0.75
Dosage Unit: mg/kg/day
7.9 3.6 3.5 .6 .1 .0 46 45 7 1 1 10.3 5.0 3.9 1.1 .2 .1 48 38 10 2 1
9.1 5.3 2.8 .5 .4 .0 58 31 6 5 0 11.5 7.5 3.4 .4 .2 .0 65 30 4 1 0
5.3 2.0 2.7 .5 .0 .1 38 50 10 1 1 12.3 7.0 4.6 .3 .4 .0 57 37 2 3 0
9.4 5.1 3.5 .6 .2 .0 52 38 6 2 0
2.56
2.06
.71
.28
.16
.05
9.8 7.8 3.2 1.6
6666 6 666 66 6
003175
538
Appendix 4
Individual Clinical Hematology Data
Males
Day 91
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
ANIMAL NUMBER
ANISO
POLY
POIK
HYPO
TOXNEUT
Group: 1 Dose Level: 0
Dosage Unit: mg/kg/day
105508
_
_
_
_
_
105517
-
-
---
105519
-
---
-
105520
-
----
105526
-
-
--
-
105527
-
---
Group: 2 Dose Level: 0.03
Dosage Unit: mg/kg/day
105514 105515 105516 105521
.. -
-
_
-
___
--
-
---
--
Group: 3 Dose Level: 0.15
Dosage Unit: mg/kg/day
105505
_ __
105510
-
-
--
-
105518
-
-
-
-
105523
-
---
-
105524
-
-
-
-
-
105528
-
*
-
-
-
Group: 4 Dose Level: 0.75
Dosage Unit: mg/kg/day
105506
_
_
_
105507
-
-
-
_
-
105509
-
-
-
-
-
105511
-
-
-
-
_
105512
-
-
-
-
-
105522
-
-
-
-
-
Covance 6329-223 3M T-6295.7
9TC00
539
ANIMAL NUMBER
Group : 1
105529 105530 105531 105535 105544 105549
MEAN S.D. N
Group: 2
105537 105541 105547 105550
MEAN S.D. N
Group : 3
105532 105538 105539 105545 105548 105552
MEAN S.D. N
Appendix 4
Individual Clinical Hematology Data
Females
Day 91
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
RBC HGB HCT MCV MCH MCHC PLT RETIC
X10 /tL
G/DL
%
FL
PG
%
X103//iL
%
Covance 6329-223 3M T-6295.7
RETIC XIOVm L
Dose Level: 0
6.13 6.50 6.44 6.71
5.26 6.81
11.9 13.0 12.0 12.1
11.3 13.4
6.31 .565 6
12.3 .77 6
Dose Level : 0.03
6.22 5.52 6.49 6.55
10.6 12.8 11.3 12.2
6.20 .472 4
11.7 .97 4
Dose Level : 0.15
6.49 6.70
6.16 6.89 6.59 6.14
12.2 12.0 12.1 12.7
11.5 11.7
6.50 .298 6
12.0 .42 6
Dosage Unit: mg/kg/day
38.3 43.2 39.2 40.1 37.0 44.1
62.5 66.5 60.9 59.9
70.4 64.7
19.4 20.0
18.6 18.0
21.5 19.7
40.3 2.79 6
64.1
3.90 6
19.5 1.21 6
Dosage Unit: mg/kg/day
37.1 40.8 37.5 41.3
59.7 73.9 57.8 63.0
17.0 23.1 17.5 18.6
39.2 2.18 4
63.6 7.19 4
19.0 2.78 4
Dosage Unit : mg/kg/day
40.0 40.8 39.3 40.9 37.6 37.8
61.6 61.0 63.8 59.3 56.9 61.6
18.8 18.0 19.7 18.4 17.5 19.0
39.4 1.44 6
60.7 2.35 6
18.6 .78 6
31.0 30.1 30.5 30.1 30.5 30.4
30.4 .33 6
28.4 31.3 30.2 29.6
29.9 1.21 4
30.6 29.5 30.8 31.1 30.7 30.9
30.6 .57 6
682 556 629 515 446 544
562 83.6 6
492 462 493 422
467 33.4 4
423 432 394 355 585 461
442 78.9 6
.2 .3 .4 .4 .3 .3
.3 .08
6
.5 .5 .6 .3
.5 .13 4
.2 .1 .3 .3 .3 .1
.2 .10
6
12 20 26 27 16 20
20 5.' 6
31 28 39 20
30 7.! 4
13 7
18 21 20
6
14 6. ( 6
TCOO
540
ANIMAL NUMBER
Appendix 4
Individual Clinical Hematology Data
Females
Day 91
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
RBC HGB HCT MCV MCH MCHC PLT RETIC
X106/^L
G/DL
%
FL
PG
%
XlOVAdi
Covance 6329-223 3M T-6295.7
RETIC X10V//L
Group : 4
105533 105534 105536 105540 105542 105551
MEAN S.D. N
Dose Level : 0.75
6.39 6.06 6.35 6.47
6.57 6.07
11.9 11.8 11.7
12.5 11.9 11.4
6.32 .210 6
11.9 .36 6
Dosage Unit: mg/kg/day
40.1 39.8 40.4 42.2 41.6
37.8
62.7 65.7
63.6 65.2 63.3 62.3
18.7
19.5 18.4 19.3 18.2 18.7
40.3 1.54 6
63.8 1.37 6
18.8 .51 6
29.8 29.7 28.9 29.5 28.7 30.1
29.4 .54 6
328 520 568 597 635 378
504 124.1
6
.1 .4 .1 .3 .0 .3
.2 .15
6
6 24
6 19
0 18
12 9.. 6
003178
541
ANIMAL NUMBER
WBC xioV^l
Appendix 4
Individual Clinical Hematology Data
Females
Day 91
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
N-SEG
LYMPH
XlOV/iL XIOVpL
MONO
EOSIN
Xl0V/tL XlOVnL
BASO
N-SEG%
XlOVpL
LYMPH %
MONO%
EOSIN%
Covance 6329-223 3M T-6295.7
BASO%
Group : 1 Dose Level : 0
Dosage Unit: mg/kg/day
105529
6.4 3.2 2.6 .5 .1 .0 50 41 8 1 1
105530 11.1 6.2 4.1 .6 .2 .0 56 37 5 2 0
105531
9.1 4.7 3.5 .6 .3 .0 51 38 7 3 0
105535 11.7 3.0 7.1 .8 .7 .1 26 61 7 6 1
105544
9.1 2.8 5.1 .6 .7 .0 30 56 6 7 0
105549
8.7 4.4 3.5 .6 .2 .0 50 40 7 2 0
MEAN S.D. N
9.4 4.0 4.3 .6 .4 .0 44 46 7 4 0
1.89
1.31
1.59
.10
.27
.04
12,.5
10,.3
1..0
2..4
6 66 6666 6 66 6
Group: 2 Dose Level : 0 .03
Dosage Unit: mg/kg/day
105537
8.3 3.5 3.0 1.3 .3 .2 42 37 15 3 2
105541 10.4 4.4 4.9 .8 .2 .0 42 47 8 2 0
105547
4.1 1.7 2.0 .3 .1 .0 41 48 8 3 0
105550 12.0 8.2 2.9 .8 .1 .0 68 24 6 1 0
MEAN S.D. N
8.7 4.4 3.2 .8 .2 .0 48 39 9 2 0
3.42
2.74
1.22
.41
.10
.10
13..2
11..2
3. 9
1, 0
1
44444444444
Group: 3 Dose Level : 0 .15
Dosage Unit: mg/kg/day
105532 105538 105539 105545 105548 105552
MEAN S.D. N
6.5 3.6 2.4 .3 .1 .0 56 37 5 2 o 9.5 5.2 3.2 .8 .2 .0 55 34 9 2 0 8.5 3.3 4.4 .5 .2 .0 39 52 6 2 1 8.8 4.4 3.5 .7 .1 .0 50 40 8 1 o 10.2 5.2 3.9 .7 .3 .0 51 38 7 3 o 8.9 4.9 3.1 .5 .4 .0 55 35 6 4 0
8.7 4.4 3.4 .6 .2 .0 51 39 7 2 o
1.25 .82 .69 .18 .12 .00
6. 4 6. 6 1. 5 1. 0
66666666666
o
Vi
542
ANIMAL NUMBER
WBC X10 /(L
Appendix 4
Individual Clinical Hematology Data
Females
Day 91
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
N-SEG
LYMPH
Xl0V/iL XIOVm L
MONO
EOS IN
x i o V m l XIO'/^L
BASO
N-SEG%
XIOVm L
LYMPH%
MONO%
EOSIN%
Covance 6329-223 3M T-6295.7
BASO%
Group: 4 Dose Level : 0.75
Dosage Unit: mg/kg/day
105533
8.2 3.1 4.3 .7 .1 .1 38 53 8 1 1
105534
8.5 4.1 3.1 1.0 .2 .1 48 37 12 3 1
105536
5.7 2.8 2.2 .6 .2 .0 50 38 10 3 0
105540 10.7 6.5 3.8 .4 .1 .0 60 35 4 1 0
105542
9.5 7.0 2.2 .3 .0 .0 74 23 3 0 0
105551
6.2 4.1 1.7 .4 .1 .0 66 27 6 1 0
MEAN S.D. N
8.1 4.6 2.9 .6 .1 .0 56 36 7 2 0
1.91
1.75
1.02
.26
.08
.05
13.1
10.4
3.5
1.2
666 6 666 66 6 6
003180
543
Appendix 4
Individual Clinical Hematology Data
Females
Day 91
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
ANIMAL NUMBER
ANISO
POLY
POIK
HYPO
TOXNEUT
Group: 1
105529 105530 105531 105535 105544 105549
Dose Level: 0
__ -----
-
Dosage Unit: mg/kg/day
_ __
- --
--
-
--
-
- --
---
Group: 2 Dose Level: 0.03
Dosage Unit: mg/kg/day
105537
_
_
___
105541
-
-
_
-
_
105547
-
-
-
-
_
105550
-
---
Group: 3
105532 105538 105539 105545 105548 105552
Dose Level: 0.15
__
--
----
-
Dosage Unit: mg/kg/day
__
--_ ----_
- ----
Group: 4 Dose Level: 0.75
Dosage Unit: mg/kg/day
105533
_
-
__
105534
-
-
_
-
_
105536
-
-
-
_
_
105540
-
-
-
-
_
105542
-
-
_
-
-
105551
-
-
-
-
_
Covance 6329-223 3M T-6295.7
003181
544
ANIMAL NUMBER
Group: 1
105508 105517 105519 105520 105526 105527
MEAN S.D. N
Group: 2
105514 105515 105516 105521
MEAN S.D. N
Group: 3
105505 105510 105518 105523 105524 105528
MEAN S.D. N
Appendix 4
Individual Clinical Hematology Data
Males
Day 153
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
RBC HGB HCT MCV MCH MCHC PLT RETIC
XIOV^iL
G/DL
FL
PG
%
XIOVi/L
%
Covance 6329-223 3M T-6295.7
RETIC XIOVm L
Dose Level : 0
6.44 6.54 7.40 6.44 6.28 6.95
12.3 13.1 12.8 12.1 11.7 12.9
6.68 .421 6
12.5 .54 6
Dose Level : 0.03
6.80 7.26 6.55 7.71
12.0 13.0 12.4 12.9
7.08 .513 4
12.6 .46 4
Dose Level : 0.15
6.35 7.19
7.53 6.39 6.74 6.50
12.6 12.6 13.2 12.2 12.8 12.2
6.78 .479 6
12.6 .38 6
Dosage Unit: mg/kg/day
39.3 43.3 42.9 38.7
38.6 42.8
61.0 66.3 58.0 60.1 61.3 61.6
19.1 20.0
17.3 18.8 18.7 18.5
40.9 2.28 6
61.4 2.74 6
18.7 .88 6
Dosage Unit: mg/kg/day
40.8 44.0 39.6 42.4
59.9 60.7
60.5 55.0
17.7 17.9 18.9 16.7
41.7
1.91 4
59.0 2.70 4
17.8 .90 4
Dosage Unit: mg/kg/day
40.5 41.3 43.4 39.8 42.8 40.2
63.7 57.5
57.6 62.3 63.5 61.9
19.9 17.5 17.6 19.2 19.1 18.8
41.3 1.47
6
61.1 2.82 6
18.7 .95 6
31.4 30.2 29.9 31.2 30.5 30.1
30.6 .62 6
29.5 29.5 31.2 30.4
30.2 .82 4
31.2 30.5 30.5 30.8 30.0 30.4
30.6 .40 6
351 379 447 643 354 613
464 131.6
6
389 618 296 630
483 167.0
4
406 496 546 783 515 366
519 146.4
6
.1 .2 .4 .0 .1 .7
.2 .26
6
.2 .2 .4 .0
.2 .16 4
.5 .2 .4 .4 .6 .6
.4 .15 6
6 13 30
0 6 49
17 18.7
6
14 15 26
0
14 10.7
4
32 14 30 26 40 39
30 9.6 6
003182
545
ANIMAL NUMBER
Group: 4
105506 105507 105509 105511 105512 105522
MEAN S.D. N
Appendix 4
individual Clinical Hematology Data
Males
Day 153
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
RBC XIOVmL
HGB G/DL
HCT MCV % ' FL
MCH MCHC
PLT RETIC
PG
%
x i o 3/m l
%
Covance 6329-223 3M T-6295.7
RETIC x i o '/m l
Dose Level : 0.75
7.78 6.93 6.08 6.10 6.61 6.38
13.4 11.7 10.3 11.1 12.0 12.1
6.65 .641 6
11.8 1.04 6
Dosage Unit : mg/kg/day
45.8 39.3 36.1 37.7 40.4
40.5
59.0 56.7 59.4 61.8
61.2
63.6
17.3 16.8 16.9 18.2 18.2 19.0
40.0 3.32 6
60.3 2.43 6
17.7 .87
6
29.3 29.7 28.5 29.5 29.7 29.9
29.4 .50 6
486 21
373 553 405 552
398 199.1
6
.4 .1 .7 1.1 1.2 .1
.6 .48
6
31 7
43 67 79
6
39 30.:
6
003183
546
ANIMAL NUMBER
WBC X103/m L
Appendix 4
Individual Clinical Hematology Data
Males
Day 153
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
N-SEG
LYMPH
XIOV/^L XIOV^L
MONO
EOSIN
XIOV/iL X103/h L
BASO
N-SEG
XIOVkL
LYMPH%
MONO%
EOSIN%
Covance 6329-223 3M T-6295.7
BASO
Group; 1 Dose Level : 0
Dosage Unit: mg/kg/day
105508
5.3 1.8 2.9 .3 .4 .0 34 54 5 7 0
105517
6.7 1.7 4.5 .4 .0 .0 25 68 6 0 0
105519
6.7 2.9 3.5 .2 .1 .0 43 52 3 1 0
105520
7.8 2.3 4.3 .7 .3 .2 30 55 9 4 2
105526
5.2 1.6 2.9 .6 .1 .0 32 56 11 1 0
105527 12.3 5.9 5.1 1.0 .1 .0 48 42 8 1 0
MEAN S.D. N
7.3 2.7 3.9 .5 .2 .0 35 54 7 2 0
2.62
1.64
.91
.29
.15
.08
8. 6 8..3 2.,9 2.7
6 66 6 6 66 6 6 6 6
Group: 2 Dose Level : 0 .03
Dosage Unit: mg/kg/day
105514 10.0 6.2 3.0 .4 .3 .0 62 30 4 3 0
105515
8.8 3.1 4.8 .6 .2 .0 35 55 7 3 0
105516 11.3 6.4 3.8 .9 .2 .0 56 34 8 2 0
105521
9.6 6.8 2.3 .5 .1 .0 70 24 5 1 0
MEAN S.D. N
9.9 5.6 3.5 .6 .2 .0 56 36 6 2 0
1.04
1.70
1.08
.22
.08
.00
15..0
13..5
1, 8
1.0
44444444444
Group: 3 Dose Level : 0 .15
Dosage Unit: mg/kg/day
105505 105510 105518 105523 105524 105528
MEAN S.D. N
11.8 8.6 2.5 .5 .3 .0 73 21 4 2 0 9.3 5.5 3.1 .6 .1 .0 59 33 7 1 0 9.7 2.9 5.9 .8 .1 .1 30 61 9 1 1
13.8 8.3 4.4 .6 .4 .0 60 32 4 3 0 6.7 1.9 4.1 .7 .1 .1 28 61 10 1 1 9.2 3.8 3.9 .8 .6 1 42 43 8 6 1
10.1 5.2 4.0 .7 .3 .0 49 42 7 2 0
2.44
2.81
1.17
.12
.21
.05
18. 2
16. 4
2..5
2.0
66666666666
003184
547
ANIMAL NUMBER
WBC X103/ML
Appendix 4
Individual Clinical Hematology Data
Males
Day 153
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
N-SEG
LYMPH
X103/*iL X103//4L
MONO
EOSIN
x i o V m l X IOVajL
BASO
N-SEG%
X10V*<L
LYMPH%
MONO%
EOSIN%
Covance 6329-223 3M T-6295.7
BASO%
Group : 4 Dose Level : 0.75
Dosage Unit: mg/kg/day
105506
6.7 2.5 3.6 .5 .1 .0 38 54 7 1 0
105507
8.9 3.9 4.4 .5 .1 .0 44 50 5 1 0
105509
13.2
10.0
1.8
1.4
.0
.0 76
13 11
0
0
105511
5.9 2.2 3.2 .3 .2 .0 37 55 6 3 0
105512
7.6 2.2 4.0 1.2 .1 .0 29 53 15 2 0
105522 11.6 5.2 4.9 .9 .5 .1 45 42 8 4 1
MEAN S.D. N
9.0 4.3 3.6 .8 .2 .0 45 44 9 2 0
2.87
3.02
1.08
.44
.18
.04
16.3
16.1
3.7
1.5
66666666666
003185
548
Appendix 4
Individual Clinical Hematology Data
Males
Day 153
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
ANIMAL NUMBER
ANISO
POLY
POIK
HYPO
TOXNEUT
Group: 1
105508 105517 105519 105520 105526 105527
Group: 2
105514 105515 105516 105521
Group: 3
105505 105510 105518 105523 105524 105528
Group: 4
105506 105507 105509 105511 105512 105522
Dose Level : 0 Dose Level: 0.03 Dose Level: 0.15 Dose Level: 0.75
Dosage Unit: mg/kg/day Dosage Unit: mg/kg/day Dosage Unit: mg/kg/day Dosage Unit: mg/kg/day
Covance 6329-223 3M T-6295.7
003186
549
ANIMAL NUMBER
Group: 1
105529 105530 105531 105535 105544 105549
MEAN S.D. N
Group: 2
105537 105541 105547 105550
MEAN S.D. N
Group: 3
105532 105538 105539 105545 105548 105552
MEAN S.D. N
Appendix 4
Individual Clinical Hematology Data
Females
Day 153
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
RBC HGB HCT MCV MCH MCHC PLT RETIC
x i o V a<l
G/DL
%
FL
PG
%
XlO'/nL
%
Covance 6329-223 3M T-6295.7
RETIC XIOViiL
Dose Level: 0
5.82 6.31 6.88 7.30
6.25 7.02
11.3 12.5 12.6 12.9 11.6 13.6
6.60 .559 6
12.4 .85 6
Dose Level: 0.03
6.74 5.74
6.96 7.20
10.9 12.2 11.7 13.1
6.66 .641 4
12.0 .92 4
Dose Level: 0.15
6.80 6.37
6.59 7.00 6.84 6.39
12.5 11.7
12.3 12.7 11.6 11.9
6.66 .257 6
12.1
.45 6
Dosage Unit: mg/kg/day
36.1 41.0 40.7 42.9 38.7
44.4
61.9 65.1 59.1 58.7 62.0
63.3
19.3 19.8 18.3 17.7
18.6
19.3
40.6 2.96 6
61.7 2.45 6
18.8 .77 6
Dosage Unit: mg/kg/day
38.5 40.3 39.0 43.9
57.0 70.3 56.0 61.0
16.2 21.2 16.8 18.2
40.4 2.44 4
61.1 6.52 4
18.1 2.23 4
Dosage Unit: mg/kg/day
40.8 38.5 40.6 41.5 38.3 39.4
60.0 60.5 61.6 59.3 55.9 61.6
18.4 18.4 18.7 18.1 17.0 18.7
39.9 1.31 6
59.8 2.12 6
18.2 .64 6
31.2 30.4 31.0 30.2 30.0 30.5
30.6 .46 6
28.4 30.2 30.0 29.8
29.6 .82 4
30.7 30.4 30.3 30.6 30.3 30.3
30.4 .18 6
609 544 586 469 498 416
520 73.1 6
.2 .5 .1 .0 .7 .7
.4 .31
6
322 385 450 391
387 52.3 4
.4 1.5
.1 .5
.6 .61 4
424 425 506 326 545 532
460 83.7 6
.7 .4 .3 .0 .2 .2
.3 .24
6
12 32
7 0 44 49
24 20.5
6
27 86
7 36
39 33.6
4
48 25 20
0 14 13
20 16.1
6
003187
550
ANIMAL NUMBER
Appendix 4
Individual Clinical Hematology Data
Females
Day 153
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
RBC HGB HCT MCV MCH MCHC PLT RETIC
x i o 6/*<l
G/DL
%
FL
PG
%
XIOV^L
%
Covance 6329-223 3M T-6295.7
RETIC XlOV^L
Group: 4
105533 105534 105536 105540 105542 105551
MEAN S.D. N
Dose Level: 0.75
6.67
6.20 6.07 5.97
6.56 6.51
12.2 12.1
11.0 11.5
11.6 11.9
6.33 .288 6
11.7 .44 6
Dosage Unit : mg/kg/day
41.2 41.4 36.8 37.3 40.0 40.3
61.7 66.7 60.7 62.4 60.9 61.9
18.4 19.5 18.2 19.2
17.6 18.3
39.5 1.98 6
62.4 2.21 6
18.5 .70 6
29.8 29.3 30.0 30.8 28.9 29.6
29.7 .65 6
320 582 563 491 671 322
492 144.0
6
.3 .3 .1 .0 .1 .2
.2 .12
6
20 19
6 0 7 13
11 7.! 6
000188
551
ANIMAL NUMBER
Group: 1
105529 105530 105531 105535 105544 105549
MEAN S.D. N
Group : 2
105537 105541 105547 105550
MEAN S.D. N
Group: 3
105532 105538 105539 105545 105548 105552
MEAN S.D. N
WBC XIOVk L
Appendix 4
Individual Clinical Hematology Data
Females
Day 153
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
N-SEG
LYMPH
x i o V m l X103/k L
MONO
EOS IN
XIOV/L XIO V m L
BASO
N -SEG%
XI O V aiL
LYMPH%
MONO*
EOSIN*
Covance 6329-223 3M T-6295.7
BASO*
Dose Level: 0
Dosage Unit: mg/kg/day
8.4 5.1 2.6 .6 .1 .0 60 31 7 1 0 8.3 1.8 5.9 .5 .1 .0 22 70 6 2 0 14.5 9.9 3.8 .7 .1 .0 68 26 5 1 0 8.3 2.4 4.4 1.0 .5 .1 28 52 12 6 1 8.7 2.9 3.9 1.3 .4 .1 34 45 15 5 1 10.0 5.3 3.8 .7 .1 .1 53 38 7 1 1
9.7 4.6 4.1 .8 .2 .0 44 44 9 3 0
2.44
2.98
1.08
.30
.18
.05
18..7
15. 9
3. 9
2..3
.5
66666666666
Dose Level : 0.03
Dosage Unit: mg/kg/day
8.5 4.2 3.0 .9 .4 .2 49 35 10 4 2
6.5 2.2 3.6 .5 .1 .1 34 56 8 1 1
15.9
10.2
2.8
2.6
.1
.1 64
18
16
1
0
6.4 3.5 2.1 .5 .2 .0 55 34 9 2 0
9.3 5.0 2.9 1.1 .2 .1 50 36 11 2 1
4.49
3.55
.62 1.00
.14
.08
12.,6
15..6
3. 6
1. 4
1. 0
44444444444
Dose Level: 0.15
Dosage Unit: mg/kg/day
5.6 2.5 2.4 .6 .1 .0 45 43 10 1 1 10.6 6.6 2.9 .8 .3 .0 63 27 7 3 0
6.3 1.1 4.5 .5 .2 .0 18 71 8 3 0 11.0 5.3 4.8 .6 .2 .0 48 44 5 2 0
7.6 3.2 3.1 .8 .4 .0 42 41 11 5 0 7.5 3.4 3.0 .5 .5 .0 45 40 7 6 1
8.1 3.7 3.4 .6 .3 .0 44 44 8 3 0
2.23
1.98
.96
.14
.15
.00
14. 5
14. 4
2. 2
1. 9
5
6666 666 6 66 6
003189
552
ANIMAL NUMBER
WBC X103/**L
Appendix 4
Individual Clinical Hematology Data
Females
Day 153
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
N-SEG
LYMPH
x i o 3/m l XIOVaL
MONO
EOS IN
x i o V m l X103/*iL
BASO
N-SEG%
XIOV^L
LYMPH%
MONO%
EOSIN%
Covance 6329-223 3M T-6295.7
BASO%
Group : 4 Dose Level : 0.75
Dosage Unit: mg/kg/day
105533
8.2 2.1 4.9 .9 .2 .1 26 60 11 3 1
105534 13.2 3.8 7.9 1.0 .4 .1 29 60 7 3 1
105536 10.1 6.6 1.9 1.3 .2 .1 65 19 13 2 1
105540 11.7 7.4 3.5 .6 .1 .0 64 30 5 1 0
105542
9.0 5.0 3.6 .3 .2 .0 55 39 3 2 0
105551
4.6 1.7 2.2 .6 .0 .0 38 48 13 1 1
MEAN S.D.
N
9.5 4.4 4.0 .8 .2 .0 46 43 9 2 1
2.99
2.33
2.19
.35
.13
.05
17.4
16.5
4.3
.9
66666666666
003190
553
Appendix 4
Individual Clinical Hematology Data
Females
Day 153
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
ANIMAL NUMBER
ANISO
POLY
POIK
HYPO
TOXNEUT
Group: 1 Dose Level: 0
105529 105530
105531 105535 105544
105549
_ _
_
-
_ _
_
_ _
_
Group: 2 Dose Level: 0.03
105537
-
105541
-
105547
_
_
_
105550
_
_
_
Group: 3
105532 105538 105539 105545 105548 105552
Dose Level: 0.15
___ ___ ___ ___
Group: 4
105533 105534 105536 105540 105542 105551
Dose Level: 0.75
___ ___ ___ ___ ___
Dosage Unit: mg/kg/day __ __
__
Dosage Unit: mg/kg/day
__ __ Dosage Unit: mg/kg/day __ __ __ __
Dosage Unit: mg/kg/day __ __ __ __ __
Covance 6329-223 3M T-6295.7
T6T?00
554
ANIMAL NUMBER
Group : 1
105508 105517 105519 105520 105526 105527
MEAN S.D. N
Group: 2
105514 105515 105516 105521
MEAN S.D. N
Group: 3
105505 105510 105518 105523 105524 105528
MEAN S.D. N
Appendix 4
Individual Clinical Hematology Data
Males
Day 182
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
RBC HGB HCT MCV MCH MCHC PLT RETIC
XlOV^L
G/DL
%
FL
PG
t
XIO'/HL
%
Covance 6329-223 3M T-6295.7
RETIC XI03/uh
Dose Level : 0
6.43 6.72 7.22 6.17
6.48 6.57
12.8 13.1 12.7 11.7
12.2 12.3
6.60 .354 6
12.5 .50 6
Dose Level : 0.03
6.88 6.47 6.61 7.86
12.1 12.2 12.5 13.1
6.96 .627 4
12.5 .45 4
Dose Level : 0.15
6.43 6.98 7.21 6.50 6.57 6.21
12.5 12.4 12.8 12.6 12.6 11.9
6.65 .372 6
12.5 .31 6
Dosage Unit: mg/kg/day
40.3 44.2 42.0 38.0 40.4 41.7
62.7 65.8 58.1 61.6 62.3 63.5
19.9 19.5 17.6 18.9 18.8 18.8
41.1 2.07 6
62.3 2.53 6
18.9 .78 6
Dosage Unit : mg/kg/day
42.5 40.7 40.8 44.5
61.7 62.9 61.7 56.6
17.6 18.8
18.9 16.7
42.1 1.79 4
60.7 2.81 4
18.0 1.05 4
Dosage Unit : mg/kg/day
41.8 40.8 42.1 40.7 41.8 39.0
65.0 58.4 58.4 62.6 63.5 62.9
19.5 17.8 17.7 19.3 19.2 19.1
41.0 1.15 6
61.8 2.76 6
18.8 .80 6
31.7 29.6 30.2 30.7 30.2 29.6
30.3 .79 6
404 399 445 591 392 - 571
467 90.4 6
28.5 29.9 30.6 29.5
29.6 .88 4
398 559 246 663
466 183.0
4
30.0 30.4 30.4 30.9 30.2 30.4
30.4 .30 6
411 464 514 526 527 380
470 63.1 6
.1 .2 .2 .1 .1 .3
.2 .08
6
.4 .2 .0 .1
.2 .17 4
.3 .3 .3 .3 .2 .3
.3 .04 6
6 13 14
6 6 20
11 5.8 6
28 13
0 8
12 11.8
4
19 21 22 20 13 19
19 3.2 6
003192
555
ANIMAL NUMBER
Appendix 4
individual Clinical Hematology Data
Males
Day 182
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
RBC HGB HCT MCV MCH MCHC PLT RETIC
XlOV/zL
G/DL
%
FL
PG
%
x i o 3/al
%
Covance 6329-223 3M T-6295.7
RETIC XlOV^L
Group: 4
105506 a 105507 105511 105512 105522
MEAN S.D. N
Dose Level : 0.75
7.69 6.64 5.76 6.46 6.44
13.3 11.0 10.4 11.7 12.3
6.32 .387 4
11.4 .83 4
Dosage Unit: mg/kg/day
44.3 38.4 35.7 39.8 41.5
57.7 57.9 62.0 61.6
64.5
17.2 16.5 18.1 18.1 19.1
38.8
2.45 4
61.5 2.72 4
17.9 1.08 4
29.9 28.5 29.2 29.4 29.6
29.2 .48 4
560 78 PA
486 429 610
401 228.0
4
.2 .3 .5 .0 .0
.2 .24 4
15 20 29
0 0
12 14.6
4
a unscheduled sacrifice on Day 179.
003193
556
ANIMAL NUMBER
WBC XIOV^L
Appendix 4
Individual Clinical Hematology Data
Males
Day 182
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
N-SEG
LYMPH
XIOV/iL X10V//L
MONO
EOSIN
x i o V m l X103/WL
BASO
N-SEG%
XlOVjiL
LYMPH%
MONO%
EOSIN%
Covance 6329-223 3M T-6295.7
BASO%
Group: 1 Dose Level : 0
Dosage Unit: mg/kg/day
105508
9.5 3.6 4.8 .6 .5 .0 38 50 6 6 0
105517
9.0 2.6 5.6 .6 .1 .1 30 62 7 1 1
105519
6.8 4.0 2.5 .3 .1 .0 58 37 4 1 0
105520 12.0 5.8 5.0 .7 .4 .1 49 42 6 3 1
105526 10.0 6.7 2.8 .4 .1 .0 67 28 4 1 0
105527 10.8 2.8 6.0 1.6 .3 .1 26 55 15 3 1
MEAN S.D. N
9.7 4.2 4.4 .7 .2 .0 45 46 7 2 0
1.76
1.66
1.46
.46
.18
.05
16.,1
12. 4
4..1
2.0
66666666666
Group: 2 Dose Level : 0 .03
Dosage Unit: mg/kg/day
105514 105515 105516 105521
8.9 5.7 2.6 .4 .2 .0 64 30 4 2 0 7.5 2.7 3.6 .9 .2 .0 36 48 12 3 1 8.1 5.8 1.9 .3 .1 .0 71 23 4 1 0 9.1 5.2 3.2 .6 .1 .0 58 35 6 1 0
MEAN S.D. N
8.4 4.8 2.8 .6 .2 .0 57 34 6 2 0
.74 1.46
.74
.26
.06
.00
15..1
10. 6
3. 8
1.0
44444444444
Group : 3 Dose Level : 0 .15
Dosage Unit: mg/kg/day
105505 105510 105518 105523 105524 105528
MEAN S.D. N
10.3 7.5 2.3 .4 .2 .0 72 22 4 2 0 9.1 4.6 3.9 .4 .1 .0 51 43 5 1 0
13.6 6.6 6.6 .3 .1 .0 48 48 2 0 0 10.8 6.3 3.8 .5 .1 .0 59 35 5 1 0
6.1 1.6 3.8 .5 .1 .0 26 63 9 1 0 10.0 4.6 4.1 .7 .6 .0 46 41 7 6 0
10.0 5.2 4.1 .5 .2 .0 50 42 5 2 0
2.44
2.10
1.39
.14
.20
.00
15. 2
13. 6
2. 4
2.1
66666666666
003194
557
ANIMAL NUMBER
Group: 4
105506 a 105507 105511 105512 105522
MEAN S.D. N
WBC X103//
Appendix 4
Individual Clinical Hematology Data
Males
Day 182
26-WEEK c a p s u l e t o x i c i t y s t u d y w i t h p e r f l u o r o o c t a n e s u l f o n i c a c i d POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
N-SEG
LYMPH
X103/aiL XIOV^L
MONO
xiovml
EOSIN XIOVm L
BASO
N-SEG%
X10 /vL
LYMPH%
MONO
EOSIN
Covance 6329-223 3M T-6295.7
BASO
Dose Level : 0.75
Dosage Unit: mg/kg/day
19.7
14.7
4.0
1.0
.0
.0 74
20
5
0
0
9.4 3.9 4.9 .4 .1 .0 42 52 5 1 0
5.1 2.0 2.3 .6 .2 .1 39 45 11 4 1
6.6 1.9 4.3 .4 .0 .0 28 66 5 0 0
9.2 3.9 4.5 .6 .2 .1 43 49 6 2 1
7.6 2.9 4.0 .5 .1 .0 38 53 7 2 0
2.09
1.13
1.16
.12
.10
.06
6.9 9.1 2.9 1.7
4 44 44 44 4 4 4 4
a Unscheduled sacrifice on Day 179.
003195
558
003196
Appendix 4
Individual Clinical Hematology Data
Males
Day 182
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
ANIMAL NUMBER
ANISO
POLY
POIK
HYPO
TOXNEUT
Group: 1
105508 105517 105519 105520 105526 105527
Dose Level : 0
__ - '-----
Dosage Unit: mg/kg/day
_-_
- ------ --
---
Group: 2 Dose Level: 0.03
Dosage Unit: mg/kg/day
105514
_
_
_
_
_
105515
-
-
-
-
-
105516 b - - - -
-
105521
-
*
-
-
-
Group: 3 Dose Level: 0.15
Dosage Unit: mg/kg/day
105505
_
_
_
_
_
105510
-
-
-
-
-
105518
-
-
-
-
_
105523
-
-
-
-
-
105524
-
-
-
-
-
105528
-
-
-
-
-
Group: 4 Dose Level: 0.75
Dosage Unit: mg/kg/day
105506 a _
___
105507
-
-
-
-
-
105511
-
-
-
-
-
105512
-
-
-
-
-
105522
-
-
-
-
-
a Unscheduled sacrifice on Day 179. b Plasmodium was observed.
559
Covance 6329-223 3M T-6295.7
ANIMAL NUMBER
Group: 1
105529 105530 105531 105535 105544 105549
MEAN S.D. N
Group: 2
105537 105541 105547 105550
MEAN S.D. N
Group: 3
105532 105538 105539 105545 105548 105552
MEAN S.D. N
Appendix 4
Individual Clinical Hematology Data
Females
Day 182
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
RBC HGB HCT MCV MCH MCHC PLT RETIC
X106/m L
G/DL
%
FL
PG
%
xi<r/*<L
%
Covance 6329-223 3M T-6295.7
RETIC X10 /<L
Dose Level: 0
5.66 6.38 6.63 7.04
6.20 6.52
11.0 12.6 12.0 12.7
11.9 12.5
6.40 .461 6
12.1 .64 6
Dose Level: 0.03
6.69 5.80 5.20 6.92
10.8 12.2
9.0 12.7
6.15 .798 4
11.2 1.66 4
Dose Level: 0.15
6.65 6.14 6.67 6.81 6.75 6.38
12.3 11.0 12.5 12.4 11.3 11.9
6.57 .256 6
11.9 .62 6
Dosage Unit: mg/kg/day
35.7 42.6 40.5 42.8 40.9 42.3
63.0 66.8 61.2 60.8 65.9 64.9
19.5 19.7
18.1 18.1
19.2 19.2
40.8 2.67 6
63.8 2.49 6
19.0 .70 6
Dosage Unit : mg/kg/day
38.9 41.4
30.1 42.7
58.2 71.3 58.0 61.8
16.2 21.1 17.4 18.3
38.3 5.67 4
62.3 6.23 4
18.2 2.09 4
Dosage Unit: mg/kg/day
40.8 37.6
41.9 41.0 37.8 40.2
61.3 61.2 62.7 60.3 56.1 63.0
18.4 17.9
18.8 18.3 16.8 18.7
39.9 1.78 6
60.8 2.50 6
18.2 .73 6
31.0 29.6 29.5 29.7 29.1 29.6
29.7 .65 6
27.9 29.5 30.0 29.7
29.3 .94 4
30.1 29.3 29.9 30.3 30.0 29.7
29.9 .35 6
595 583 534 369 439 383
484 100.1
6
442 380 501 394
429 54.7 4
373 381 400 318 484 517
412 74.4 6
.2 .4 .3 .2 .8 .6
.4 .24 6
.2 .2 .4 .1
.2 .13 4
.3 .3 .2 .0 .2 .1
.2 .12 6
11 26 20 14 50 39
27 15.1
6
13 12 21
7
13 5.8 4
20 18 13
0 14
6
12 7.5 6
003197
560
ANIMAL NUMBER
Appendix 4
Individual Clinical Hematology Data
Females
Day 182
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
RBC HGB HCT MCV MCH MCHC PLT RETIC
XlOV^L
G/DL
%
FL
PG
%
XIOVm L
Covance 6329-223 3M T-6295.7
RETIC XIOVk L
Group: 4
105533 105534 105536 105540 105542 105551
MEAN S.D. N
Dose Level : 0.75
6.00 5.65 6.08 5.99 6.75 6.09
11.3 11.0 10.9 11.6
11.9 11.3
6.09 .360 6
11.3 .37 6
Dosage Unit: mg/kg/day
37.6 37.7 39.3 38.6 43.4 38.4
62.6 66.8 64.6 64.5
64.3 63.1
18.9 19.4
17.9 19.3 17.7
18.6
39.2 2.17 6
64.3 1.46 6
18.6 .71 6
30.1 29.1 27.8 29.9 27.5 29.5
29.0 1.09 6
288 587 559 454 725 328
490 166.0
6
.2 .5 .0 .0 .4 .1
.2 .21
6
12 28
0 0 27 6
12 12.
6
003198
561
ANIMAL NUMBER
WBC xioV ml
Appendix 4
Individual Clinical Hematology Data
Females
Day 182
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
N-SEG
LYMPH
x i o V m l XlOV/tL
MONO
EOSIN
xioV/a, XloV/tL
BASO
N-SEG%
X10 V/iL
LYMPH%
MONO%
EOSIN%
Covance 6329-223 3M T-6295.7
BASO%
Group: 1 Dose Level : 0
Dosage Unit: mg/kg/day
105529
14.6
11.4
2.5
.6
.1
.1 78 17
4
1
1
105530
7.3 2.6 3.9 .6 .2 .0 35 54 8 3 0
105531 10.5 5.2 4.3 .7 .2 .1 50 41 7 2 1
105535 13.9 5.5 7.0 1.0 .3 .1 39 50 7 2 1
105544 10.4 2.9 6.2 .6 .6 .0 28 60 6 6 0
105549
5.4 2.4 2.1 .7 .1 .0 44 40 14 2 0
MEAN S.D. N
10.4 5.0 4.3 .7 .2 .0 46 44 8 3 0
3.59
3.41
1.96
.15
.19
.05
17. 5
15.,1
3. 4
1. 8
.5
66666666666
Group : 2 Dose Level : 0.03
Dosage Unit: mg/kg/day
105537 10.1 5.4 3.1 1.1 .4 .2 54 30 11 4 2
105541
6.6 2.4 3.5 .5 .2 .0 37 53 7 3 0
105547
6.8
4.0
2.4 -
.4
.1
.0
58
35
6
1
0
105550 10.4 5.5 3.7 .8 .4 .0 53 35 7 4 0
MEAN S.D.
N
8.5 4.3 3.2 .7 .3 .0 50 38 8 3 0
2.05
1.45
.57
.32
.15
.10
9. 3 10. 1 2. 2 1. 4 1.,0
44444444444
Group : 3 Dose Level : 0.15
Dosage Unit: mg/kg/day
105532
8.2 3.9 3.8 .4 .1 .0 48 46 5 1 0
105538
9.2 4.5 3.8 .6 .3 .0 49 41 6 4 0
105539
7.5 1.6 4.9 .8 .1 .1 22 65 10 2 2
105545 11.0 6.3 3.9 .6 .1 .0 57 36 6 1 0
105548 11.3 6.2 3.7 .6 .7 .0 55 33 5 6 0
105552
8.0 4.3 3.0 .3 .4 .0 54 37 4 4 0
MEAN S.D. N
9.2 4.5 3.8 .6 .3 .0 48 43 6 3 0
1.61
1.73
.61
.18
.24
.04
13. 0
11. 7
2. 1
2. 0
8
66666666666
003199
562
ANIMAL NUMBER
Group : 4
105533 105534 105536 105540 105542 105551
MEAN S.D. N
WBC X10 /L
Appendix 4
Individual Clinical Hematology Data
Females
Day 182
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
N-SEG
LYMPH
x i o V ail XlOV^L
MONO
EOS IN
X103/AL XIOVm L
BASO
N-SEG%
X I O V aiL
LYMPH%
MONO
EOSIN
Covance 6329-223 3M T-6295.7
BASO
Dose Level s 0.75
Dosage Unit: mg/kg/day
7.5 3.2 3.8 .4 .1 .1 42 51 5 1 1
12.1 5.0 6.0 1.0 .2 .1 41 49 8 1 1 8.4 4.1 2.8 1.2 .2 .1 49 34 14 2 1
10.3 5.9 3.8 .5 .1 .0 58 37 5 1 0
13.4 3.0 9.3 .8 .3 .1 22 69 6 3 0 6.4 4.0 1.8 .5 .1 .0 63 28 8 1 0
9.7 4.2 4.6 .7 .2 .1 46 45 8 2 0
2.73
1.10
2.70
.32
.08
.05
14.6
14.8
3.4
.8
66666666666
003200
563
Appendix 4
Individual Clinical Hematology Data
Females
Day 182
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
ANIMAL NUMBER
ANISO
POLY
POIK
HYPO
TOXNEUT
Group: 1
105529 105530 105531 105535 105544 105549
Group: 2
105537 105541 105547 105550
Group: 3
105532 105538 105539 105545 105548 105552
Group: 4
105533 105534 105536 105540 105542 105551
Dose Level: 0 Dose Level: 0.03 Dose Level: 0.15 Dose Level: 0.75
Dosage Unit: mg/kg/day Dosage Unit: mg/kg/day Dosage Unit: mg/kg/day Dosage Unit: mg/kg/day
Covance 6329-223 3M T-6295.7
003201
564
ANIMAL NUMBER
APPENDIX 4
Individual Clinical Hematology Data
Males
Day 217
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOF.OOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS
RBC HGB HCT MCV MCH MCHC PLT RETIC
X107//L
G/DL
.%
FL
PG
%
XIO'/uL
%
Covance 6329-223 3M Study No. T-6295.7
RETIC XIOVmL
Group : 1
105520 105526
MEAN S.D. N
Group : 3
105505 105523
MEAN S.D. N
Group : 4
105511 105522
MEAN S.D. N
Dose Level: 0
6.27 6.26
12.1 11.8
6.26 .007 2
12.0 .21 2
Dose Level: 0.15
6.53 6.45
13.0 12.4
6.49 .057 2
12.7 .42 2
Dose Level: 0.75
5.93 5.87
11.6 11.5
5.90 .042 2
11.6 .07 2
Dosage Unit: mg/kg/day
38.3 37.9
61.0 60.5
19.3 18.9
38.1 .28 2
60.8 .35 2
19.1 .28
2
Dosage Unit: mg/kg/day
41.6 39.8
63.7 61.8
19.9 19.3
40.7 1.27 2
62.8 1.34 2
19.6 .42 2
Dosage Unit: mg/kg/day
38.2 37.3
64.5 63.5
19.5 19.6
37.8 .64 2
64.0 .71 2
19.5 .07 2
31.7 31.2
31.5 .35 2
31.3 31.2
31.2 .07 2
30.3 30.9
30.6 .42 2
620 346
483 193.7
2
404 572
488 118.8
2
485 453
469 22.6 2
.3 .4
.4 .07 2
.4 .2
.3 .14 2
.3 .6
.4 .21 2
19 25
22 4.2 2
26 13
20 9.2 2
18 35
26 12.0
2
003202
ANIMAL NUMBER
WBC X103/^L
APPENDIX 4
Individual clinical Hematology Data
Males
Day 217
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS
N-SEG
LYMPH
X107//L X107/JL
MONO
EOSIN
3U07/'L XIOVwL
BASO
N -SEG%
X10r/uh
LYMPH%
MONO!
Covance 6329-223 3M Study No. T-6295.7
EOSIH%
BASO%
Group: i Dose Level : 0
Dosage Unit: mg/kg/day
IO5520 105526
MEAN 3.D. N
8.5 2.5 5.2 .5 .3 .0 30 61 6 3 1 6.1 2.3 2.9 .7 .2 .0 37 47 12 3 1
7.3 2.4 4.0 .6 .2 .0 34 54 9 3 1
1.70 .14 1.63 .14 .07 .00
4.9 9.9 4.2
.0
.0
22222222222
Group: 3 Dose Level : 0.15
Dosage Unit: mg/kg/day
IU5505
8.8 4.7 3.0 .7 .4 .0 53 34 8 5 0
105523
14.2 7.6 6.0 .4 .2 .0 53 42
31
0
MEAN S.D. N
11.5 6.2 4.5 .6 .3 .0 53 38 6 3 0
3.82
2.05
2.12
.21
.14
.00
.0 5.7 3.5 2.8
.0
22222222222
Group: 4 Dose Level : 0.75
Dosage Unit: mg/kg/day
105511
8.9 4.1 3.9
.5 .4
.0 46 44
5
4
0
105522 14.7 7.9 5.0 1.3 .5 .0 54 34 9 4 0
MEAN S.D. N
11.8 6.0 4.4 .9 .4 .0 50 39 7 4 0
4.10
2.69
.78
.57
.07
.00
5.7 7.1 2.8
.0
0
2 22 22 2 22 2 22
o
CO
fO
003204
APPENDIX 4
Individual Clinical Hematology Data
Males
Day 217
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOF.OOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS
ANIMAL NUMBER
ANISO
POLY
POIK
HYPO
TOXNEUT
Group: 1 Dose Level: 0
105520 105526
-
--
Group: 3
I055U5 105523
Dose Level: 0.15
-----
Group: 4
105511 105522
Dose Level: 0.75
-----
Dosage Unit: mg/kg/day --
Dosage Unit: mg/kg/day ---
Dosage Unit: mg/kg/day ---
Covance 6329-223 3M Study No. T-6295.7
ANIMAL NUMBER
APPENDIX 4
Individual Clinical Hematology Data
Females
Day 217
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-629S) IN CYNOMOLGUS
RBC HGB HCT MCV MCH MCHC PLT RETIC
XIOV/'L
G/DL
%
FL
PG
%
XIO'/oL
%
Covance 6329-223 3M Study No. T-6295.7
RETIC X10 /k L
Group : i
105529 11)5549
MEAN S.D. N
Group: 3
IU5539 105552
MEAN S.D. N
Group: 4
105533 105542
MEAN S.D. N
Dose Level : 0
5.44 6.45
10.9 12.6
5.94
.714 2
11.8 1.20 2
Dose Level : 0.15
6.07 6.20
11.8 12.0
6.14 .092 2
11.9 .14 2
Dose Level : 0.75
6.13 6.72
11.8 12.2
6.42 .417 2
12.0 .28 2
Dosage Unit: mg/kg/day
33.5 40.3
61.5 62.4
20.1 19.6
36.9 4.81 2
62.0 .64 2
19.8 .35 2
Dosage Unit: mg/kg/day
37.2 38.0
61.4 61.3
19.5 19.4
37.6 .57 2
61.4 .07 2
19.5 .07
2
Dosage Unit: mg/kg/day
38.2 42.3
62.2 63.0
19.2 18.2
40.2 2.90 2
62.6 .57 2
18.7 .71 2
32.7 31.3
32.0 .99 2
31.8 31.6
31.7 .14 2
30.8 28.9
29.8 1.34 2
547 390
468 111.0
2
382 435
408 37.5 2
330 557
444 160.5
2
.1 .5
.3 .28 2
.2 .5
.4 .21 2
.3 .7
.5 .28 2
5 32
18 19.1
2
12 31
22 13.4
2
18 47
32 20.5
2
003205
ANIMAL NUMBER
WBC X10 7//L
APPENDIX 4
Individual Clinical Hematology Data
Females
Day 217
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS
N-SEG
LYMPH
X10//<L X107//L
MONO
EOSIN
X10 7 i/L XIO/uL
BASO
N-SEG%
xio7l
LYMPH%
MONO%
Covance 6329-223 3M Study No. T-6295.7
EOSIN%
BASO%
Group: 1 Dose Level : 0
Dosage Unit : mg/kg/day
105529
10.1 6.1 3.0
.8 .1
.0 60 30
8
1
1115549
6.2 3.1 2.5
.4 .1
.0 50 41
7
2
0
MEAN S.D. N
8.2 4.6 2.8 .6 .1 .0 55 36 8 2 0
2.76
2.12
.35
.28
.00
.00
222222
7.1 7.8 .7 .7 2 22 2 2
Group: 3 Dose Level : 0.15
Dosage Unit : mg/Kg/day
IU5539 IU5552
6.9 1.8 4.3 .7 .2 .1 26 61 10 3 i 8.4 3.5 3.8 .5 .5 .0 41 45 6 6 i
MEAN S.D. H
7.6 2.6 4.0 .6 .4 .0 34 53 8 4 i
1.06
1.20
.35
.14
.21
.07
10.6
11.3
2.8
2.1
22222222222
Group : 4 Dose Level : 0.75
Dosage Unit; mg/kg/day
105533
7.7 2.1 5.0 .3 .3 .0 27 65 4 4 0
105542 10.9 3.0 6.7 .8 .2 .1 28 62 8 2 1
MEAN S.D. N
9.3 2.6 5.8 .6 .2 .0 28 64 6 3 0
2.26 .64 1.20 .35 .07 .07
.7 2.1 2.8 1.4
22222222222
902C00
003207
APPENDIX 4
Individual Clinical Hematology Data
Females
Day 217
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS
ANIMAL NUMBER
ANISO
POLY
POIK
HYPO
TOXNEUT
Group: 1
105529 105549
Dose Level: 0
-----
Group: 3
105539 105552
Dose Level: 0.15
-----
Group: 4 Dose Level: 0.75
105533
-
-
-
105542
-
-
-
Dosage Unit: mg/kg/day
---
Dosage Unit: mg/kg/day
---
Dosage Unit: mg/kg/day
---
Covance 6329-223 3M Study No. T-6295.7
ANIMAL NUMBER
APPENDIX 4
Individual clinical Hematology Data
Males
Day 245
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS
RBC HGB HCT MCV MCH MCHC PLT RETIC
XlOVliL
G/DL
%
FL
PG
%
X10V//L
Covance 6329-223 3M Study No. T-6295.7
RETIC XIOV^L
Group: 1
105520 105526
MEAN S.D. N
Group: 3
105505 105523
MEAN S.D. N
Group: 4
105511 105522
MEAN S.D. N
Dose Level: 0
6.75 6.28
13.0 12.2
6.52 .332 2
12.6 .57 2
Dose Level: 0.15
6.75 6.82
13.3 13.3
6.78 .049 2
13.3 .00 2
Dose Level: 0.75
6.06 6.33
11.4 12.4
6.20
.191 2
11.9 .71 2
Dosage Unit: mg/kg/day
40.6 37.9
60.2 60.3
19.3 19.4
39.2 1.91 2
60.2 .07 2
19.4 .07 2
Dosage Unit: mg/kg/day
42.5 41.8
62.9 61.3
19.8 19.4
42.2 .49 2
62.1 1.13 2
19.6 .28 2
Dosage unit: mg/kg/day
39.0 39.9
64.4 63.0
18.8 19.5
39.5 .64 2
63.7 .99 2
19.2 .49 2
32.1 32.1
32.1 .00 2
31.4 31.7
31.6 .21 2
29.2 31.0
30.1 1.27 2
685 428
556 181.7
2
467 519
493 36.8 2
501 562
532 43.1 2
.1 .3
.2 .14 2
.1 .2
.2 .07 2
.8 .4
.6 .28 2
7 19
13 8.5 2
7 14
10 4.9 2
48 25
36 16.3
2
SQZVOO
ANIMAL NUMBER
WBC X10//<L
APPENDIX 4
Individual Clinical Hematology Data
Males
Day 245
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS
N-SEG
LYMPH
X10V//L x i o V hl
MONO
EOSIN
XlQ /uL XIO'AuL
BASO
N -SEG%
X I O V a/L
LYMPH%
MONO%
Covance 6329-223 3M Study No. T-6295.7
EOSIN%
BASO%
Group: 1 Dose Level : 0
Dosage Unit: mg/kg/day
105520 12.1 3.8 7.6 .5 .3 .0 31 63 4 2 0
105526
8.0 2.7 4.6 .4 .3 .0 33 58 5 4 0
MEAN S.D. H
10.0 3.2 6.1 .4 .3 .0 32 60 4 3 0
2.90 .78 2.12 .07 .00 .00
1.4 3.5
.7 1.4
22222222222
Group: 3 Dose Level : 0.15
Dosage Unit: mg/kg/day
105505 105523
10.6 5.2 4.1 .8 .4 .0 49 39 12.2 5.8 5.6 .4 .3 .0 48 46
a4 32
0 0
MEAN S.D.
N
11.4 5.5 4.8 .6 .4 .0 48 42 6 3 0
1.13 .42 1.06 .28 .07 .00
.7 4.9 3.5 1.4
22222222222
Group : 4 Dose Level : 0.75
Dosage Unit: mg/kg/day
105511 105522
9.5 3.6 4.9 .6 .4 .1 38 51 17.3 7.6 7.4 1.5 .6 .1 44 43
64 94
1 1
MEAN S.D. N
13.4 5.6 6.2 1.0 .5 .1 41 47
84
1
5.52
2.83
1.77
.64
.14
.00
4.2 5.7 2.1
.0
22222222222
60ZD00
APPENDIX 4
Individual Clinical Hematology Data
Males
Day 24S
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS
ANIMAL NUMBER
ANISO
POLY
POIK
HYPO
TOXNEUT
Covance 6329-223 3M Study No. T-6295.7
Group: 1 Dose Level: 0
Dosage Unit: mg/kg/day
105520
105526
-
-
-
-
-
'J
Group : 3 Dose Level: 0.15
Dosage Unit: mg/kg/day
105505 105523
Group : 4 Dose Level: 0.75
Dosage Unit: mg/kg/day
105511 105522
TZVQQ
ANIMAL NUMBER
APPENDIX 4
Individual clinical Hematology Data
Females
Day 245
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS
RBC HGB HCT MCV MCH MCHC PLT RETIC
X10 IwL
G/DL
%
FL
PG
%
X10 /nL
%
Covance 6329-223 3M Study No. T-6295.7
RETIC X10 InL
Group: 1
105529 105549
MEAN S.D. N
Group: 3
105539 105552
MEAN S.D. N
Group : 4
105533 105542
MEAN S.D. N
Dose Level : 0
5.70 6.74
11.3 13.3
6.22 .735 2
12.3 1.41 2
Dose Level : 0.15
6.88 6.61
12.9 12.5
6.74 .191 2
12.7 .28 2
Dose Level: 0.75
6.38 7.02
12.2 12.8
6.70 .453 2
12.5 .42
2
Dosage Unit: mg/kg/day
34.9 41.9
61.1 62.1
19.8 19.7
38.4 4.95 -t
61.6 .71 2
19.8 .07 2
Dosage Unit: mg/kg/day
40.9 40.4
59.4 61.2
18.7 18.9
40.7 .35 2
60.3 1.27 2
18.8 .14 2
Dosage Unit: mg/kg/day
39.9 44.1
62.5 62.8
19.2 18.2
42.0 2.97 2
62.7 .21 2
18.7 .71 2
32.4 31.7
32.1 .49 2
31.4 31.0
31.2 .28 2
30.7 29.0
29.8 1.20 2
577 461
519 82.0 2
391 459
425 48.1 2
335 546
440 149.2
2
.2 .3
.2 .07 2
.1 .2
.2 .07 2
.1 .4
.2 .21 2
11 20
16 6.4 2
7 13
10 4.2 2
6 28
17 15.6
2
TTZOO
ANIMAL NUMBER
WBC XI0 //tL
APPENDIX 4
Individual Clinical Hematology Data
Females
Day 245
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT <PFOS; T-6295) IN CYNOMOLGUS
N-SEG
LYMPH
X10/nL X107pL
MONO
EOSIN
X10 /nL X105/L
BASO
N-SEG%
X10/ivL
LYMPH%
MONO%
Covane 6329-223 3M Study No. T-6295.7
EOSIN%
BASO%
Group: 1 Dose Level : 0
Dosage Unit: mg/kg/day
105529 12.5 9.1 2.8 .5 .1 .n 73 22 4 1 0
105549
10.3 5.1 4.0
.9 .3
.0 50 39
8
3
0
MEAN S.D. N
11.4 7.1 3.4 .7 .2 .0 62 30 6 2 0
1.56
2.83
.85
.28 .14
.00
16.3
12.0
2.8
1.4
.0
2 2 2 2 2 it
2222
Group : 3 Dose Level : 0.15
Dosage Unit: mg/kg/day
105539
7.5 .9 5.3 1.0 .2 .1 12 71 13 3 1
105552 11.4 5.1 4.6 1.0 .6 .0 45 40 9 5 0
MEAN S.D. N
9.4 3.0 5.0 1.0 .4 .0 28 56 11 4 0
2.76
2.97
.49
.00
.28
.07
23.3
21.9
2.8
1.4
.7
22222222222
Group: 4 Dose Level;: 0.75
Dosage Unit: mg/kg/day
105533
10.8 4.5 5.0 1.1 .2 .1 41 46 10
11
105542 11.1 2.6 7.5 .7 .3 .1 23 67 6 3 1
MEAN S.D. N
11.0 3.6 6.2 .9 .2 .1 32 56 8 2 1
.21 1.34 1.77
.28
.07
.00
12.7
14.8
2.8
1.4
0
22 2 22 2 22 2 22
C.J
N
APPENDIX 4
Individual Clinical Hematology Data
Females
Day 245
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-62951 IN CYNOMOLGUS
ANIMAL NUMBER
AIJISO
POLY
POIK
HYPO
TOXNEUT
Group: 1
105529 105549
Group: 3
105539 105552
Group : 4
105533 105542
Dose Level: 0 -
Dose Level: 0.15 -
Dose Level: 0.75 -
Dosage Unit : mg/kg/day
-
-
Dosage Unit : mg/kg/day
-
-
Dosage Unit: mg/kg/day --
a Plasmodium was observed.
Covance 6329-223 3M Study No. T-6295.7
oo
C*5
N
ANIMAL NUMBER
APPENDIX 4
Individual Clinical Hematology Data
Males
Day 322
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS
RBC HGB -HCT MCV MCH MCHC PLT RETIC
X10(/L
G/DL
%
FL
PG
%
XlOVfiL
%
Covance 6329-223 3M Study No. T-6295.7
RETIC XIO'VjiL
Group : 1
105520 105526
MEAN S.D. N
Group : 3
105505 105523
MEAN S.D. N
Group : 4
105511 105522
MEAN S.D. N
Dose Level : 0
6.78 6.67
12.9 12.4
6.72 .078 2
12.6 .35 2
Dose Level: 0.15
6.89 6.71
13.6 12.8
6.80 .127 2
13.2 .57
2
Dose Level: 0.75
6.08 6.36
11.5 12.1
6.22 .198 2
11.8 .42 2
Dosage Uni t: mg /kg/day
40.6 39.8
59.8 59.7
19.0 18.6
40.2 .57 2
59.8 .07 2
18.8 .28 2
Dosage Unit: mg/kg/day
43.2 40.6
62.6 60.5
19.8 19.1
41.9 1.84 2
61.5 1.48 2
19.4 .49 2
Dosage Unit: mg/kg/day
37.8 38.3
62.1 60.2
18.9 19.0
38.1 .35 2
61.1 1.34 2
19.0 .07 2
31.8 31.2
31.5 .42 2
31.6 31.5
31.5 .07 2
30.5 31.5
31.0 .71 2
692 396
544 209.3
2
434 548
491 80.6 2
542 603
572 43.1 2
.5 .1
.3 .28 2
.2 .1
.2 .07 2
.8 .3
.6 .35 2
34 7
20 19.1
2
14 7
10 4.9 2
49 19
34 21.2
2
003214
ANIMAL NUMBER
WBC X10/gL
APPENDIX 4
Individual Clinical Hematology Data
Males
Day 322
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS
N-SEG
LYMPH
X10`7/iL X10 7//L
MONO
EOSIN
XIO'/n L X10 7/jL
BASO
N -SEG%
XIO '/iiL
LYMPH%
MONO%
Covance 6329-223 3M Study No. T-6295.7
Eosun
BASO%
Group : 1 Dose Level : 0
Dosage Unit: mg/kg/day
105520 105526
9.5 4.3 4.5
.6 .1
.0 45 47
7
l
0
7.8 4.0 3.0 .7 .1 .0 52 38 9 l 0
MEAN
S.D. N
8.6 4.2 3.8
.6 .1
.0 48 42
8
1
0
1.20 .21 1.06 .07 .00 .00
4.9 6.4 1.4
.0
222222222 22
Group: 3 Dose Level : 0 .15
Dosage Unit: mg/kg/day
105505 13.7 9.6 3.0 .9 .2 .0 70 22 7 1 0 105523 11.8 6.7 4.4 .6 .1 .0 57 37 5 1 0
MEAN S.D. N
12.8 8.2 3.7 .8 .2 .0 64 30 6 1 0
1.34
2.05
.99
.21
.07
.00
9.2 10.6
1.4
.0
222222222 22
Group : 4 Dose Level: 0 .75
Dosage Unit: mg/kg/day
105511
6.3 2.2 3.1
.8 .2 .1 36 49 12
3
1
105522 11.6 5.8 4.7 .9 .1 .0 50 40 8 1 0
MEAN S.D. N
9.0 4.0 3.9
.8 .2
.0 43 44 10
2
0
3.75
2.55
1.13
.07
.07
.07
9.9 6.4 2.8 1.4
2 2 2 2 2 2 2 2 2- 2 2
ooazis
9T2C00
APPENDIX 4
Individual clinical Hematology Data
Males
Day 322
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTAHE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS
ANIMAL NUMBER
ANISO
POLY
POIK
HYPO
TOXNEUT
Group: 1 Dose Level: 0
105520 105526
-
Group: 3 Dose Level: 0.15
105505 105523
-
Group: 4
105511 105522
Dose Level: 0.75
-----
Dosage Unit: mg/kg/day
Dosage Unit: mg/kg/day
Dosage Unit: mg/kg/day ---
Covance 6329-223 3M Study No. T-6295.7
ANIMAL NUMBER
APPENDIX 4
Individual Clinical Hematology Data
Females
Day 322
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS
RBC HGB . HCT MCV MCH MCHC PLT RETIC
X10* /ivL
G/DL
%
FL
PG
%
X10 /L
%
Covance 6329-223 3M Study No. T-6295.7
RETIC XIO'/h L
Group : 1
105529 105549
MEAN S .D. N
Group : 3
105539 105552
MEAN S.D. N
Group: 4
105533 105542
MEAN S.D. N
Dose Level: 0
6.04 6.61
11.9 12.8
6.32 .403 2
12.3 .64 2
Dose Level: 0.15
6.81 6.71
12.5 12.5
6.76 .071
2
12.5 .00 2
Dose Level: 0.75
6.20 6.81
11.6 12.2
6.50 .431 2
11.9 .42 2
Dosage Unit: mg/kg/day
36.9 39.9
61.1 60.4
19.7 19.4
38.4 2.12 2
60.8 .49 2
19.6 .21 2
Dosage Unit: mg/kg/day
39.6 40.7
58.2 60.7
18.3 18.6
40.1 .78 2
59.4 1.77 2
18.4 .21 2
Dosage Unit: mg/kg/day
37.9 41.0
61.2 60.3
18.8 17.9
39.5 2.19 2
60.8 .64 2
18.4 .64 2
32.2 32.1
32.1 .07 2
31.5 30.6
31.0 .64 2
30.7 29.7
30.2 .71 2
645 447
546 140.0
2
399 546
472 103.9
2
314 534
424 155.6
2
.1 .3
.2 .14 2
.4 .3
.4 .07 2
.1 .5
.3 .28 2
6 20
13 9.9 2
27 20
24 4.9 2
6 34
20 19.8
2
003217
ANIMAL NUMBER
WBC XX07/-L
APPENDIX 4
Individual Clinical Hematology Data
Females
Day 322
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS
N-SEG
LYMPH
X10 />vL Xl0'/nL
MONO
EOSIN
XIO'/iiL XlO'AuL
BASO
N -SEG%
X10/L
LYMPH%
MONO%
Covance 6329-223 3M Study No. T-6295.7
EOSINl
BASO%
Group : i Dose Level: 0
Dosage Unit: mg/kg/day
105529 105549
14.9
10.0
3.2
1.4
.2
.0
67
22
10
8.7 4.4 3.3
.6 .3
.0 51 38
7
10 30
MEAN S.D. N
11.8 7.2 3.2 1.0 .2 .0 59 30
8
0
4.38
3.96
.07
.57
.07
.00
11.3
11.3
2.1
1.4
222222 222 22
Group : 3 Dose Level: 0.15
Dosage Unit: mg/kg/day
105539
7.4 2.0 4.5 .7 .2 .0 27 61 10 3 0
105552 11.4 6.5 3.9 .4 .6 .0 57 34 4 5 0
MEAN S.D. N
9.4 4.2 4.2 .6 .4 .0 42 48 7 4 0
2.83
3.18
.42
.21
.28
.00
21.2
19.1
4.2
1.4
222 222 222 22
Group: 4 Dose Level : 0.75
Dosage Unit: mg/kg/day
105533
7.8 2.3 5.0
.5 .1 .0 29 63
7
i0
105542
10.0 3.1 6.1
.6 .2 .0 31 61
6
2
0
MEAN
S.D. N
8.9 2.7 5.6
.6 .2
.0 30 62
6
2
0
1.56 .57 .78 .07 .07 .00 1.4 1.4 .7 .7
222 222 222 22
003218
003219
APPENDIX 4
Individual Clinical Hematology Data
Females
Day 322
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-629SI IN CYNOMOLGUS
ANIMAL NUMBER
ANISO
POLY
POIK
HYPO
TOXNEUT
Group:
105529 105549
1 Dose
-
Level: 0
---
Group: 3 Dose Level: 0.15
105539
-
-
-
105552 - - -
Group:
105533 105542
4 Dose
-
Level: 0.75
---
Dosage Unit: mg/kg/day
---
Dosage Unit: mg/kg/day
---
Dosage Unit: mg/kg/day
---
Covance 6329-223 3M Study No. T-6295.7
ANIMAL NUMBER
APPENDIX 4
Individual Clinical Hematology Data
Males
Day 456
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS
RBC HGB HCT MCV MCH MCHC PLT RETIC
X10///L
G/DL
%
FL
PG
%
x i o 7/vl
%
Covance 6329-223 3M Study No. T-6295.7
RETIC X107i/L
Group: 1
105520 105526
MEAN S.D. N
Group: 3
105505 105523
MEAN S.D. N
Group: 4
105511 105522
MEAN S.D. N
Dose Level: 0
6.82 6.44
13.3 12.5
6.63 .269 2
12.9 .57
2
Dose Level: 0.15
7.19 7.12
14.1 13.8
7.16 .049 2
14.0 .21 2
Dose Level: 0.75
5.93 6.68
11.9 13.2
6.30 .530 2
12.6 .92 2
Dosage Unit: mg/kg/day
41.2 39.3
60.4 61.0
19.4 19.4
40.2 1.34 2
60.7 .42 2
19.4 .00 2
Dosage Unit: mg/kg/day
46.3 44.9
64.3 63.0
19.6 19.4
45.6 .99 2
63.7 .92 2
19.5 .14
2
Dosage Unit: mg/kg/day
38.7 42.5
65.3 63.7
20.1 19.8
40.6 2.69 2
64.5 1.13 2
19.9
.21 2
32.2 31.8
32.0 .28 2
30.5 30.8
30.6 .21 2
30.9 31.1
31.0 .14 2
584 337
460 174.7
2
.4 .2
.3 .14 2
415 566
490 106.8
2
.5 .1
.3 .28 2
445 576
510 92.6 2
1.4 .0
.7 .99 2
27 13
20 9. 2
36 7
22 20.
2
83 0
42 58.
2
003220
ANIMAL NUMBER
WBC XIOV//L
APPENDIX 4
Individual Clinical Hematology Data
Males
Day 456
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS
N-SEG
LYMPH
XIOVo L Xl0'/(/L
MONO
EOSIN
XIO'/itL XlOVivL
BASO
N-SEG%
XIO'/^L
LYMPH%
MONO%
Covance 6329-223 3M Study No. T-6295.7
EOSIN%
BASO%
Group: 1 Dose Level : 0
Dosage Unit: mg/kg/day
105520 11.2 5.4 4.9 .7 .1 .1 48 44 6 1 1 105526 12.0 7.5 3.8 .6 .1 .0 62 32 5 1 0
MEAN S.D. N
11.6 6.4 4.4 .6 .1 .0 55 38 6 1 0 .57 1.48 .78 .07 .00 .07 9.9 8.5 .7 .0 .7 22222222222
Group: 3 Dose Level : 0.15
Dosage Unit: mg/kg/day
105505 10.7 4.1 5.6 .8 .2 .0 38 52 7 2 0 105523 12.5 5.7 6.2 .5 .2 .0 45 49 4 1 0
MEAN S.D.
N
11.6 4.9 5.9 .6 .2 .0 42 50 6 2 0
1.27
1.13
.42
.21
.00
.00
4.9 2.1 2.1
.7
0
22222222222
Group: 4 Dose Level : 0.75
Dosage Unit: mg/kg/day
105511 12.0 7.5 3.5 .7 .2 .1 63 29 6 1 1
105522
21.2
13.1
6.0
1.6
.5
.1 62 28
7
3
0
MEAN S.D. N
16.6
10.3
4.8
1.2
.4
.1 62 28
6
2
0
6.51
3.96
1.77
.64
.21
.00
.7 .7 .7 1.4
22222222222
TZZOO
APPENDIX 4
Individual Clinical Hematology Data
Males
Day 456
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS
ANIMAL NUMBER
ANISO
POLY
POIK
HYPO
TOXNEUT
Covance 6329-223 3M Study No. T-6295.7
Group: 1
105520 105526
Dose Level: 0
-----
Dosage Unit: mg/kg/day
---
|
Group: 3 Dose Level: 0.15
Dosage Unit: mg/kg/day
105505 105523
-
-- ----
-
Group: 4
105511 I5522
Dose Level: 0.75
-----
Dosage Unit: mg/kg/day
---
zzzcoo
ANIMAL NUMBER
APPENDIX 4
Individual Clinical Hematology Data
Females
Day 456
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS
RBC HGB HCT MCV MCH MCHC PLT RET1C
XlO'/xL
G/DL
*%
FL
PG
%
XIOVoL
%
Covance 6329-223 3M Study No. T-6295.7
RETIC X10 7//L
Group: i
105529 105549
MEAN S.D. N
Group: 3
105539 105552
MEAN S.D. N
Group: 4
105533 105542
MEAN S.D. N
Dose Level : 0
5.63 6.88
11.3 13.5
6.26 .884 2
12.4 1.56 2
Dos Level: 0.15
6.61 6.70
12.7 12.7
6.66 .064 2
12.7 .00 2
Dose Level : 0.75
6.62 7.51
12.7 13.5
7.06 .629 2
13.1 .57 2
Dosage Unit: mg/kg/day
34.8 42.2
61.8 61.3
20.1 19.6
38.5 5.23 2
61.6 .35 2
19.8 .35 2
Dor-age Unit: mg/kg/day
40.2 41.4
60.9 61.9
19.3 19.0
40.8 .85 2
61.4 .71
2
19.2 .21 2
Dosage Unit: mg/kg/day
40.7 45.2
61.4 60.1
19.1 18.0
42.9 3.18 2
60.8 .92 2
18.5 .78 2
32.6 31.9
32.2 .49 2
31.7 30.6
31.2 .78 2
31.2 29.9
30.6 .92 2
580 407
494 122.3
2
441 461
451 14.1 2
293 598
446 215.7
2
.6 .4
.5 .14
.4 .2
.3 .14 2
.0 .3
.2 .21 2
34 28
31 4.2 2
26 13
20 9.2 2
0 23
12 16.3
2
003223
ANIMAL NUMBER
WBC X107//L
APPENDIX 4
Individual Clinical Hematology Data
Females
Day 456
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS
N-SEG
LYMPH
XlO/fjL X107//L
MONO
EOSIN
XlO'/i'L X10V//L
BASO
N-SEG%
XIO'A/L
LYMPH%
MOHO%
Covance 6329-223 3M Study No. T-6295.7
EOSINt
BAS0%
Group : 1 Dose Level : 0
Dosage Unit: mg/kg/day
105529 105549
8.2 4.5 2.9 .6 .2 .0 55 36 7 2 0
9.3 4.3 3.8 .8 .4 .0 46 41
84
0
MEAN S.D. N
8.8 4.4 3.4 .7 .3 .0 50 38 8 3 0
.78 .14 .64 .14 .14 .00 2 2 22 2 2
6.4 3.5
.7 1.4
2 2 -3 2 2
Group: 3 Dose Level : 0.15
Dosage Unit: mg/kg/day
105539
11.1 5.0 4.7 1.0 .4 .0 45 43
93
0
105552
8.7 2.6 4.6 .8 .8 .0 29 52 9 9 0
MEAN S.D. N
9.9 3.8 4.6 .9 .6 .0 37 48 9 6 0
1.70
1.70
.07
.14
.28
.00
11.3
6.4
.0 4.2
22222222222
Group: 4 Dose Level : 0.75
Dosage Unit: mg/kg/day
105533
9.9 3.5 5.1 1.0 .2 .1 36 51 10 2 1
105542
11.2 2.5 7.3 .9 .4 .2 22 65
84
2
MEAN S.D. N
10.6 3.0 6.2 1.0 .3 .2 29 58 9 3 2
.92 .71 1.56 .07 .14 .07
9.9 9.9 1.4 1.4
22 22 2 22 22 22
003224
S2ZC00
APPENDIX 4
Individual Clinical Hematology Data
Females
Day 456
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS
ANIMAL NUMBER
ANISO
POLY
POIK
HYPO
TOXHEUT
Group: 1 Dose Level: 0
105529
-
-
-
105549
-
-
-
Group: 3 Dose Level: 0.15
105539
-
-
-
105552
-
-
-
Group: 4
105533 105542
Dose Level: 0.75
-----
Dosage Unit: mg/kg/day
---
Dosage Unit: mg/kg/day
---
Dosage Unit: mg/kg/day
---
Covance 6329-223 3M Study No. T-6295.7
ANIMAL NUMBER
APPENDIX 4
Individual Clinical Hematology Data
Males
Day 546
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS: T-6295) IN CYNOMOLGUS
RBC HGB HCT MCV MCH MCHC PLT RETIC
X10 7/:L
G/DL
%
FL
PG
%
XlO'/iiL
%
Covance 6329-223 3M Study No. T-6295.7
RETIC X107//L
Group : i
105520 105526
MEAN S.D. N
Group: 3
105505 105523
MEAN S.D. N
Group: 4
105511 105522
MEAN S.D. N
Dose Level : 0
6.54 6.59
12.6 12.6
6.56 .035 2
12.6 .00 2
Dose Level : 0.15
6.80 7.00
13.5 13.8
6.90 .141 2
13.6 .21 2
Dose Level: 0.75
6.42 6.42
12.7 12.5
6.42 .000 2
12.6 .14 2
Dosage Unit: mg/kg/day
39.9 41.4
61.0 62.8
19.2 19.1
40.7 1.06 2
61.9 1.27 2
19.2 .07 2
Dosage Unit: mg/kg/day
43.6 44.2
64.1 63.1
19.8 19.8
43.9 .42 2
63.6 .71 2
19.8 .00 2
Dosage Unit: mg/kg/day
43.5 41.3
67.6 64.3
19.7 19.5
42.4 1.56 2
66.0 2.33 2
19.6 .14 2
31.5 30.5
31.0 .71 2
30.9 31.3
31.1 .28 2
29.2 30.3
29.8 .78 2
503 366
434 96.9 2
377 369
373 5.7 2
478 562
520 59.4 2
.7 .3
.5 .28 2
.7 .7
.7 .00 2
.9 .3
.6 .42 2
46 20
33 18.4
2
48 49
48 .7
2
58 19
38 27.6
2
003226
ANIMAL NUMBER
WBC XIOVpL
APPENDIX 4
Individual Clinical Hematology Data
Males
Day 546
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS
N-SEG
LYMPH
X10'/i/L X10 /L
MONO
EOSIN
XIO'A/L XIOVuL
BASO
N -SEG%
X107.//L
LYHPH%
MONO%
Covance 6329-223 3M Study No. T-6295.7
EOSIH%
BASOt
Group: 1 Dose Level : 0
Dosage Unit: mg/kg/day
105520 105526
7.1 2.0 4.3
.5 .1 .3 28 60
7
1
4
9.6 4.2 4.1 1.1 .1 .0 44 43 11 1 1
MEAN S.D. N
8.4 3.1 4.2 .8 .1 .2 36 52 9 1 2
1.77
1.56
.14
.42
.00
.21
11.3
12.0
2.8
.0 2.1
22222222222
Group: 3 Dose Level : 0.15
Dosage Unit: mg/kg/day
105505
8.1 3.8 3.2 .9 .2 .1 47 39 11 2 1
105523
13.7 6.2 6.2 .7 .5 .1 45 45
53
1
MEAN S.D. N
10.9 5.0 4.7 .8 .4 .1 46 42 8 2 1
3.96
1.70
2.12
.14
.21
.00
1.4 4.2 4.2
.7 .0
222 2 22 222 22
Group: 4 Dose Level : 0.75
Dosage Unit: mg/kg/day
105511
15.7
10.9
3.4
1.2
.1
.1 70
22
7
1
1
105522 16.2 8.8 5.4 1.3 .4 .3 54 33 8 2 2
MEAN S.D. N
16.0 9.8 4.4 1.2 .2 .2 62 28 8 2 2 .35 1.48 1.41 .07 .21 .14 11.3 7.8 .7 ,7 .7 22222222222
003227
003228
APPENDIX 4
Individual clinical Hematology Data
Males
Day 546
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS
ANIMAL NUMBER
ANISO
POLY
POIK
HYPO
TOXNEUT
Group: 1
105520 105526
Dose Level: 0
-----
Group: 3
105505 105523
Dose Level: 0.15
-----
Group: 4
105511 105522
Dose Level: 0.75
-----
Dosage Unit: mg/kg/day
---
Dosage Unit: mg/kg/day
---
Dosage Unit: mg/kg/day
---
Covance 6329-223 3M Study No. T-6295.7
ANIMAL NUMBER
APPENDIX 4
Individual Clinical Hematology Data
Females
Day 546
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTAHE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS
RBC HGB . HCT MCV MCH MCHC PLT RETIC
XlO'/i/L
G/DL
%
FL
PG
%
X107//L
%
Covance 6329-223 3M Study No. T-6295.7
RETIC XIO'/m D
Group : 1
105529 105549
MEAN S.D. N
Group : 3
105539 105552
MEAN S.D. N
Group : 4
105533 105542
MEAN S.D. N
Dose Level: 0
5.52 6.51
11.1 12.6
6.02 .700 2
11.8 1.06 2
Dose Level: 0.15
6.60 6.33
12.6 12.0
6.46 .191 2
12.3 .42 2
Dose Level: 0.75
6.62 6.81
12.5 12.3
6.72 .134 2
12.4 .14 2
Dosage Unit: mg/kg/day
34.6 40.5
62.6 62.3
20.1 19.4
37.5 4.17 2
62.5 .21 2
19.8 .49 2
Dosage Unit: mg/kg/day
41.2 39.3
62.4 62.1
19.1 18.9
40.2 1.34 2
62.2 .21 2
19.0 .14 2
Dosage Unit: mg/kg/day
41.0 40.6
61.9 59.7
18.9 18.1
40.8 .28 2
60.8 1.56 2
18.5 .57 2
32.1 31.1
31.6 .71 2
30.7 .30.5
30.6 .14 2
30.5 30.3
30.4 .14 2
533 483
508 35.4 2
405 408
406 2.1 2
293 500
396 146.4
2
.6 33 .3 20
.4 26 .21 9.2 22
.3 20 .6 38
.4 29 .21 12.7 22
.2 13 .4 27
.3 20 .14 9.9 2 2
00322
ANIMAL NUMBER
WBC XIOV/jL
APPENDIX 4
Individual Clinical Hematology Data
Females
Day 546
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS
N-SEG
LYMPH
XlO'/pL X10 7L
MONO
EOSII1
XlOVciL XlO/wL
BASO
N -SEG%
XlO/jiL
LYMPH%
MONO%
Covance 6329-223 3M Study No. T-6295.7
EOSIN%
BASOI
Group: 1 Dose Level : 0
Dosage Unit: mg/kg/day
105529
6.9 3.5 2.5 .7 .2 .1 50 36 10 2 1
105549
15.6
10.5
3.2
1.3
.4
.2 67
20
9
3
1
MEAN S.D.
M
11.2 7.0 2.8 1.0 .3 .2 58 28 10 2 1
6.15
4.95
.49
.42
.14
.07
12.0
11.3
.7
.7
22222222222
Group : 3 Dose Level : 0.15
Dosage Unit: mg/kg/day
105539 13.8 7.1 5.1 1.0 .4 .2 51 37 8 3 2
105552
9.2 3.8 3.4 1.1 .7 .2 41 37 12 7 2
MEAN S.D. N
11.5 5.4 4.2 1.0 .6 .2 46 37 10 5 2
3.25
2.33
1.20
.07
.21
.00
7.1
.0 2.8 2.8
22222222222
Group : 4 Dose Level : 0.75
Dosage Unit: mg/kg/day
105533
9.8 3.2 5.7 .5 .1 .2 33 58 5 1 2
105542 11.0 3.0 7.0 .5 .3 .1 28 64 5 2 i
MEAN S.D. N
10.4 3.1 6.4 .5 .2 .2 30 61 5 2 2
.85 .14 .92 .00 .14 .07
3.5 4.2
.0
.7
22222222222
OEZCOO
003231
APPENDIX 4
Individual Clinical Hematology Data
Females
Day 546
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS
ANIMAL NUMBER
ANISO
POLY
POIK
HYPO
TOXNEUT
Group: 1 Dose Level: 0
105529 105549
Group: 3 Dose Level: 0.15
105539
-
-
-
105552
-
-
-
Group: 4 Dose Level: 0.75
105533
-
-
-
105542
-
-
-
Dosage Unit: mg/kg/day
Dosage Unit: mg/kg/day --Dosage Unit: mg/kg/day ---
Covance 6329-223 3M Study No. T-6295.7
ANIMAL NUMBER
GLU MG/DL
Appendix 4
Individual Clinical Chemistry Data
Hales
Day -27
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
UN MG/DL
CREAT
T PRO
MG/DL ' G/DL
ALB G/DL
GLOB G/DL
T BILI MG/DL
SBA UMOL/L
CHOL MG/DL
Covature 6329-223 3M T-6295.7
TRIG MG/DL
Group : 1
I0S508 105517 105519 105520 105526 105527
MEAN S.D. N
Group: 2
105514 105515 105516 105521
MEAN S.D. N
Group: 3
105505 105510 105518 105523 105524 105528
MEAN S.D. N
Dose Level: 0
62 22 76 21 74 27 69 17 75 19 99 17
76
12.5 6
20 3. 8 6
Dose Level: 0. 03
76 17 69 17 58 29 75 16
70 8.3 4
20 6. 2 4
Dose Level: 0. 15
59 20 138 16
95 22 76 20 69 25 58 24
82 30.4
6
21 3. 3 6
Dosage Unit: mg/kg/day
1.0 8.7 4.6 1.3 9.2 4.7
1.2 9.3 5.0 1.1 8.7 4.9 1.1 9.4 5.2 1.2 8.8 4.9
1.2 .10 6
9.0 .32 6
4.9 .21 6
Dosage Unit: mg/kg/day
1.2 9.7
1.0 9.5 1.1 8.8 1.4 10.2
5.5 4.6 5.0 5.6
1.2 .17 4
9.6 .58 4
5.2 .46 4
Dosage Unit: mg/kg/day
1.2 9.3 .9 8.8
1.5 10.1 1.1 9.3 1.4 9.6 1.3 9.7
5.2 4.4 5.3 5.2 5.2
5.2
1.2 .22 6
9.5
.44 6
5.1 .34 6
4.1 4.5 4.3 3.8 4.2 3.9
4.1 .26 6
4.2 4.9 3.8 4.6
4.4 .48 4
4.1 4.4 4.8 4.1 4.4 4.5
4.4 .26 6
1.3 1.0
.3 .7 .3 .2
.6 .45 6
.5 .2 .6 .3
.4 .18 4
1.3 .3 .5 .3 .7 .7
.6 .37
6
5 11 10
9 9 9
9 2,,0 6
88 137 174 111 150 170
138 33..7 6
71 92 58 78 63 58
70 13,.3
6
9 8 11 8
9 1..4 4
138 111
98 93
110 20..1 4
41 48 113 41
61 35,,0
4
14 10
9 8 10 8
10 2. 2 6
186 157 124 124 141 175
151 26. 1 6
48 59 55 53 62 57
56 4. 9 6
003232
565
ANIMAL NUMBER
GLU MG/DL
Appendix 4
Individual Clinical Chemistry Data
Males
Day -27
26-w e e k c a p s u l e t o x i c i t y s t u d y w i t h p e r f l u o r o o c t a n e s u l f o n i c a c i d POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
UN MG/DL
CREAT MG/DL
T PRO G/DL
ALB G/DL
GLOB G/DL
T BILI MG/DL
SBA UMOL/L
CHOL MG/DL
Covance 6329-223 3M T-6295.7
TRIG MG/DL
Group : 4
105506 105507 105509 105511 105512 105522
MEAN S.D. N
Dose Level : 0.75
67 18 102 22
71 22 58 21
75 22 64 18
73 15.4
6
20 2..0 6
Dosage Unit: mg/kg/day
1.3 9.6 5.1 1.4 9.9 5.0 1.4 9.5 5.3 1.1 8.8 4.7
1.3 9.2 5.3 1.3 9.5 5.5
1.3 .11
6
9.4 .38 6
5.2 .28 6
4.5 4.9 4.2 4.1 3.9 4.0
4.3 .37 6
.4 .4 .8 1.0 .3 .3
.5 .29
6
10 7
10 8
10 9
9 1.3 6
129 121 117 115 188 159
138 29.3 6
68 58 62 55 77 83
67 11.0
6
003233
566
ANIMAL NUMBER
Appendix 4
Individual Clinical Chemistry Data
Males
Day -27
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
AST/SGOT ALT/SGPT ALK PHOS
IU/L
IU/L
IU/L
GGT IU/L
SDH IU/L
CK IU/L
AMYLASE LIPASE
IU/L
IU/L
P AMYL U/L
Covance 6329-223 3M T-6295.7
Group: 1
105508 105517 105519 105520 105526 105527
MEAN S.D. N
Group: 2
105514 105515 105516 105521
MEAN S.D. N
Group: 3
105505 105510 105518 105523 105524 105528
MEAN S.D. N
Dose Level: 0
58 24 84 51 58 33 36 26 58 31 43 29
56 16. 5
6
32 9. 7 6
Dose Level: 0.03
53 27 38 43 43 48 43 26
44 6.3 4
36 11.2
4
Dose Level : 0.15
66 99 39 29 54 34 99 78 84 118
93 56
72 23.5
6
69 35.7
6
Dosage Unit: mg/kg/day
546 628 514 866 1156 556
152 125 117
88 211 113
8 9 9 4
7 6
711 252.6
6
134 42.8 6
7 1.9 6
Dosage Unit: mg/kg/day
642 787 1002 369
155 125 182 103
4 4 2 3
700 265.6
4
141 34.5 4
3 1.0 4
Dosage Unit: mg/kg/day
720 814
579 716 1165 624
194 130 124
82 154 .
278
12 4 2
16 10
5
770 210.3
6
160 68.4 6
8 5.4 6
1086 1908
783 660 1671 692
1133 535.3 6
1955 348 848 595
936 709.0
4
670 1109 1047 1549
820 1329
1087 322.3 6
451 508 448 336 250 376
395 93.4 6
413 715 435 340
476 164. 6
4
367 450 326 471 469 236
386 94. 5 6
12 226
12 17 25 37
55 84.4
6
19 43 60 17
35 20.6
4
133 15 33 29 56 39
51 42.4
6
284 325 249 220 168 235
247 54 6
243 441 326 196
302 107..4
4
190 301 218 291 296 156
242 62. 4 6
003234
567
ANIMAL NUMBER
Appendix 4
Individual Clinical Chemistry Data
Males
Day -27
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
AST/SGOT ALT/SGPT ALK PHOS
IU/L
IU/L
IU/L
GGT IU/L
SDH IU/L
CK IU/L
AMYLASE LIPASE
IU/L
IU/L
P AMYL U/L
Covance 6329-223 3M T-6295.7
Group: 4
105506 105507 105509 105511 105512 105522
MEAN S.D. N
Dose Level: 0.75
54 49 54 94 80 181 71 32
69 48 80 78
68 11. 7
6
80 54. 2
6
Dosage Unit: rag/kg/day
1443 447 585 927
646 992
167
138 156 199 105 259
6 9 6 6 5 5
840 360.9
6
171 53.3 6
6 1.5 6
1602 575
1265 540 907
1676
1094 497.4 6
653 515 704 543 396 362
529 135.6
6
52 19 39 99 15 21
41 31.8
6
359 326 435 325 274 224
324 72.2 6
003235
568
003236
Appendix 4
Individual Clinical- Chemistry Data
Males
Day -27
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
ANIMAL NUMBER
CA MG/DL
I PHOS MG/DL
NA MMOL/L
K MMOL/L
CL MMOL/L
Group: 1
105508 105517 105519 105520 105526 105527
MEAN S.D, N
Group: 2
105514 105515 105516 105521
MEAN S.D. N
Group: 3
105505 105510 105518 105523 105524 105528
MEAN S.D. N
Dose Level : 0
10.2 10.3 11.1 10.5 11.8 10.7
6.5 5.8 6.6 6.1 7.5 5.0
10.8 .60 6
6.2 .84
6
Dose Level: 0 ..03
12.2 11.3 11.1 12.0
6.5 6.9 7.1 6.1
11.6 .53 4
6.6 .44
4
Dose Level: 0 ,.15
11.9 10.7 12.2 11.2 11.9 10.9
5.9 7.5 6.9 6.6 8.8 6.7
11.5 .62 6
7.1 .99 6
Dosage Unit: mg/kg/day
154 4.9 106 154 4.8 106
161 5.9 113 158 5.7 111
166 6.1 111 160 4.9 109
159 4.6 6
5.4 .58 6
109 2 6
Dosage Unit: mg/kg/day
171 6.2 114
159 5.8 110 159 5.5 109 167 6.1 112
164 6.0 4
5.9 .32
4
111 2 4
Dosage Unit: mg/kg/day
161 5.8 112 156 5.8 111 169 7.2 113 164 6.1 116 168 7.0 110 158 6.3 108
163 5.3 6
6.4 .60 6
112 2
6
569
Covance 6329-223 3M T-6295.7
Appendix 4
Individual Clinical Chemistry Data
Males
Day -27
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
ANIMAL NUMBER
CA MG/DL
I PHOS MG/DL
NA MMOL/L
K MMOL/L
CL MMOL/L
Group: 4
105506 105507 105509 105511 105512 105522
MEAN S.D. N
Dose Level : 0.75
11.8 11.3 10.9 10.5
11.8 11.7
8.0 6.0 5.9 6.1 7.0 8.3
11.3 .54
6
6.9 1.06
6
Dosage Unit: mg/kg/day
165 6.1 112 157 6.5 108 158 5.5 104 156 4.8 106 162 5.8 109 168 6.3 110
161 4.8 6
5.8 .62 6
108 2 6
Covance 6329-223 3M T-6295.7
cznoo
570
ANIMAL NUMBER
GLU MG/DL
Appendix 4
Individual Clinical Chemistry Data
Females
Day -27
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
UN MG/DL
CREAT MG/DL
T PRO G/DL
ALB G/DL
GLOB G/DL
T BILI MG/DL
SBA UMOL/L
CHOL MG/DL
Covance 6329-223 3M T-6295.7
TRIG MG/DL
Group: 1
105529 105530 105531 105535 105544 105549
MEAN S.D. N
Group: 2
105537 105541 105547 105550
MEAN S.D. N
Group: 3
105532 105538 105539 105545 105548 105552
MEAN S.D. N
Dose Level: 0
54 23 108 23
70 23 51 19 82 22 92 21
76 22.2
6
22
1.6 6
Dose Level : 0.03
71 21 66 23 89 22 67 24
73 10.7
4
22 1.3 4
Dose Level: 0.15
86 20 87 21
82 29 72 20 55 21
74 27
76 12.0
6
23 3.9 6
Dosage Unit: mg/kg/day
1.2 9.4 1.3 9.9 1.3 8.6 1.3 9.9 1.2 10.8 1.1 9.0
5.1 5.5 4.6 4.6 4.7 4.9
1.2 .08 6
9.6 .78 6
4.9 .35 6
Dosage Unit: mg/kg/day
1.3 10.0 1.2 9.2 1.2 8.9 1.1 9.0
4.9 4.5 4.6 4.8
1.2 .08 4
9.3 .50 4
4.7 .18 4
Dosage Unit: mg/kg/day
1.2 10.7 1.1 9.8 1.3 9.2 1.1 9.1 1.0 9.1 1.1 9.8
5.5 5.2
3.9 4.7 4.4 4.6
1.1 .10 6
9.6 .62 6
4.7 .57 6
4.3 4.4 4.0 5.3 6.1 4.1
4.7 .83 6
5.1 4.7 4.3 4.2
4.6 .41 4
5.2 4.6 5.3 4.4 4.7 5.2
4.9 .38 6
1.2 .3 .5 .5 .4 .3
.5 .34
6
.5 .7 .3 .6
.5 .17 4
.8 .3 .6 .9 .5 .6
.6 .21 6
7 10
7 4 7 7
7 1.9 6
93 168 137 203 133 159
149 37.2 6
56 91 54 131 56 48
73 32.4
6
5 120 6 133 9 146 6 120
6 130 1.7 12.4 44
68 69 55 56
62 7.5 4
7 7 7 37 11 6
12 12.1
6
162 142 141 156 122 140
144 14.0 6
50 42 66 74 63 53
58 11.7
6
8CZH00
571
ANIMAL NUMBER
GLU MG/DL
Appendix 4
Individual Clinical Chemistry Data
Females
Day -27
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
UN MG/DL
CREAT MG/DL
T PRO G/DL
ALB G/DL
GLOB G/DL
T BILI MG/DL
SBA UMOL/L
CHOL MG/DL
Covance 6329-223 3M T-6295.7
TRIG MG/DL
Group: 4
105533 105534 105536 105540 105542 105551
MEAN S.D. N
Dose Level: 0.75
106 27 71 21 88 17 74 26
71 25 60 26
78 16.3
6
24
3.9 6
Dosage Unit: mg/kg/day
1.3 9.4 1.4 10.1 1.2 10.5 1.1 8.6 1.3 8.8
.9 8.8
4.9 5.5 4.6 4.4 4.6 4.5
1.2 .18 6
9.4 .78 6
4.8 .40 6
4.5 4.6 5.9 4.2 4.2 4.3
4.6 .65 6
.4 .4 .3 .4 .5 1.3
.6 .37 6
11 8 9 8 9 7
9 1.4 6
163 149 137 164 152 158
154 10.1 6
69 65 53 37 86 56
61 16.6
6
003239
572
ANIMAL NUMBER
Appendix 4 Individual Clinical Chemistry Data
Females
Day -27
2G-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
AST/SGOT ALT/SGPT ALK PHOS
IU/L
IU/L
IU/L
GGT IU/L
SDH IU/L
CK IU/L
AMYLASE LIPASE
IU/L
IU/L
P AMYL U/L
Covance G329-223 3H T-6295.7
Group: 1
105529 105530 105531 105535 105544 105549
MEAN S.D. N
Group: 2
105537 105541 105547 105550
MEAN S.D. N
Group: 3
105532 105538 105539 105545 105548 105552
MEAN S.D. N
Dose Level:: 0
66 202 65 211 75 215 61 48 61 82 55 83
64 6.7 6
140 76.,9 6
Dose Level :: 0 .03
68 89 54 146
44 80 50 98
54 10.2
4
103 29. 4 4
Dose Level:: 0 .15
77 76 68 135
39 65 140 160
74 143
48 78
74
35.5 6
110 41. 0 6
Dosage Unit: mg/kg/day
195 101 274 121 217 98 550 163 256 204 254 50
3 5 7 5 3 3
291 130.1
6
123 54.0 6
4 1. 6 6
Dosage Unit: mg/kg/day
200 166 184 72
210 62 211 75
2 3 3 4
201 12.5 4
94 48.5
4
3 8
4
Dosage Unit: mg/kg/day
201 454 122 198 334 232
257 118.5
6
127 120
64 41 80
91
87 32.9
6
2 4 2 8 6 3
4 2. 4 6
484 1588
792 872 896 1242
979 384,,3
6
706 395 477 356
484 156..7
4
1192 1003
362 663 1073 769
844 306. 4
6
425 281 360 314 595 272
374 121..9
6
219 293 433 566
378 153. 7
4
366 411 269 484 352 617
416 121. 0
6
27 39 46 12 27 19
28 12..5
6
265 135 211 184 342 185
220 73 6
25 12 17 48
26 15. 9
4
152 189 286 322
237 79 4
35 46 44 25
0 62
35 21. 2
6
177 230 179 272 210 393
244 81 6
003240
573
ANIMAL NUMBER
Appendix 4
Individual Clinical Chemistry Data
Females
Day -27
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
AST/SGOT ALT/SGPT ALK PHOS
IU/L
IU/L
IU/L
GGT IU/L
SDH IU/L
CK IU/L
AMYLASE LIPASE
IU/L
IU/L
P AMYL U/L
Covance 6329-223 3M T-6295.7
Group: 4
105533 105534 105536 105540 105542 105551
MEAN S.D. N
Dose Level: 0.75
101 216 63 88
68 148 57 126 74 99 67 63
72 15. 4
6
123 54..2 6
Dosage Unit: mg/kg/day
301 121 329 64 575 63 182 52 204 79 269 70
5 3 7 4
3 1
310 141.4
6
75 24.3
6
4 2.0 6
3858 902
2229 417
1377 964
1624 1251. 5
6
411 545 336 380 294 337
384 88.6 6
25 0
15 39 31
4
19 15.4
6
269 343 205 223 196 246
247 54 6
003241
574
ZZVOO
Appendix 4
Individual Clinical Chemistry Data
Females
Day -27
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
ANIMAL NUMBER
CA MG/DL
I PHOS MG/DL
NA MMOL/L
K MMOL/L
CL MMOL/L
Group : 1
105529 105530 105531 105535 105544 105549
MEAN S.D. N
Group: 2
105537 105541 105547 105550
MEAN S.D. N
Group: 3
105532 105538 105539 105545 105548 105552
MEAN S.D. N
Dose Level : 0
10.9 13.0 10.4 12.4
11.5 10.3
5.8 6.5 5.6 7.1
6.8 5.7
11.4 1.10 6
6.2 .63 6
Dose Level: 0,.03
10.9 11.7
10.3 10.8
4.4 3.8 4.4 6.1
10.9 .58 4
4.7 .99 4
Dose Level: 0,.15
11.5 11.5 10.5 10.3 10.6 11.6
6.2 5.6 6.1 4.9 5.3 7.1
11.0 .59 6
5.9 .78 6
Dosage Unit: mg/kg/day
155 5.6 106 173 8.0 119 159 5.4 110 166 6.4 116
167 6.0 118 156 5.7 112
163 7.1 6
6.2 .96 6
114 5 6
Dosage Unit: mg/kg/day
165 5.2 113 164 6.5 117 158 5.4 112 165 6.5 119
163 3.4 4
5.9 .70 4
115 3 4
Dosage Unit: mg/kg/day
167 6.4 113 164 6.3 116 164 6.3 118 156 5.3 111 152 5.5 112 166 7.0 118
162 6.1 6
6.1 .63 6
115 3 6
575
Covance 6329-223 3M T-6295.7
Appendix 4
Individual Clinical Chemistry Data
Females
Day -27
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
ANIMAL NUMBER
CA MG/DL
I PHOS MG/DL
NA MMOL/L
K MMOL/L
CL MMOL/L
Group: 4
105533 105534 105536 105540 105542 105551
MEAN S.D. N
Dose Level : 0.75
10.9 11.6 12.1 10.7 11.7 10.7
5.1 5.7
5.7 6.1 4.7
5.6
11.3 .59 6
5.5 .50 6
Dosage Unit: mg/kg/day
163 5.1 114 164 6.3 112 168 6.0 115 159 6.8 116 167 7.1 115 155 5.3 113
163 4.9 6
6.1 .80 6
114 1 6
Covance 6329-223 3M T-6295.7
003243
576
ANIMAL NUMBER
Group: 1
105508 105517 105519 105520 105526 105527
MEAN S.D. N
Group: 2
105514 105515 105516 105521
MEAN S.D. N
Group: 3
105505 105510 105518 105523 105524 105528
MEAN S.D. N
GLU MG/DL
Appendix 4
Individual Clinical Chemistry Data
Males
Day 37
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; 1'-6295) IN CYNOMOLGUS MONKEYS
UN MG/DL
CREAT MG/DL
T PRO G/DL
ALB G/DL
GLOB G/DL
T BILI MG/DL
SBA UMOL/L
CHOL MG/DL
Covance 6329-223 3M T-6295.7
TRIG MG/DL
Dose Level: 0
54 20 68 19 57 26 62 19 54 19 65 16
60 5.9 6
20 3. 3 6
Dose Level: 0. 03
65 22 72 14 58 21 53 16
62 8.3 4
18 3.,9 4
Dose Level: 0. 15
52 17 62 17
71 19 68 18 68 26 47 28
61 9.8 6
21 4.,9 6
Dosage Unit: mg/kg/day
1.1 9.2 4.8 1.2 9.9 4.8 1.1 8.5 4.5 1.0 8.7 4.8
.9 8.4 4.6 1.2 8.8 4.8
1.1 .12 6
8.9 .56 6
4.7 .13 6
Dosage Unit: mg/kg/day
1.4 10.0 1.1 9.9 1.0 7.8 1.3 9.5
5.7
4.8 4.7 4.9
1.2 .18 4
9.3 1.02
4
5.0 .46 4
Dosage Unit: mg/kg/day
1.1 9.0 5.0 .8 9.0 4.7
1.4 9.7 4.9 1.1 9.3 5.2 1.4 8.8 4.5 1.1 9.4 4.7
1.2
.23 6
9.2 .33 6
4.8 .25 6
4.4 5.1 4.0 3.9 3.8 4.0
4.2 .49 6
4.3 5.1 3.1 4.6
4.3 .85 4
4.0 4.3 4.8 4.1 4.3 4.7
4.4 .32 6
1.4 1.1
.4 .9 .4 .4
.8 .43
6
.6 .2 .4 .4
.4 .16
4
1.0 .3 .4 .3 .6 .7
.6 .27
6
8 11
9 7 10 8
9 1.,5 6
118 171 161 117 134 139
140 22.,1 6
9 148 7 132 8 108 6 83
8 118 1. 3 28. 4 44
7 176 7 159 8 135 8 116 7 134 9 155
8 146 8 21. 5
66
70 85 45 90 48 74
69 18.,7
6
51 45 50 41
47 4. 6 4
50 54 61 65 59 56
58 5. 3 6
003244
577
ANIMAL NUMBER
GLU MG/DL
Appendix 4
Individual Clinical Chemistry Data
Males
Day 37
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
UN MG/DL
CREAT MG/DL
T PRO G/DL
ALB G/DL
GLOB G/DL
T BILI MG/DL
SBA UMOL/L
CHOL MG/DL
Covance 6329-223 3M T-6295.7
TRIG MG/DL
Group : 4
105506 105507 105509 105511 105512 105522
MEAN S.D. N
Dose Level : 0.75
58 20 75 24 66 19 54 21
64 23 71 18
65 7.8 6
21 2.3 6
Dosage Unit: mg/kg/day
1.4 9.1 4.9 1.4 9.4 5.0 1.3 9.9 5.4 1.1 9.3 4.5
1.2 8.8 5.1 1.3 9.4 5.5
1.3 .12 6
9.3 .37 6
5.1 .36 6
4.2 4.4 4.5 4.8 3.7 3.9
4.2 .40 6
.5 .3 .4 .7 .2 .4
.4 .17
6
8 112 109
6 109
72
6 127
68
5 130
62
8 156 108
9 143
128
7 130 1.5 18.0 66
91 27
6
003245
578
ANIMAL NUMBER
Appendix 4
Individual Clinical Chemistry Data
Males
Day 37
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
AST/SGOT ALT/SGPT ALK PHOS
IU/L
IU/L
IU/L
GGT IU/L
SDH IU/L
CK IU/L
AMYLASE LIPASE
IU/L
IU/L
P AMYL U/L
Covance 6329-223 3M T-6295.7
Group: 1
105508 105517 105519 105520 105526 105527
MEAN S.D. N
Group: 2
105514 105515 105516 105521
MEAN S.D. N
Group: 3
105505 105510 105518 105523 105524 105528
MEAN S.D. N
Dose Level: 0
37 30
53 59 46 28 26 23
35 27 71 69
45 15.9
6
39 19.5
6
Dose Level: 0.03
30 23 38 53 35 36 45 46
37 6.3 4
40 13.0
4
Dose Level : 0.15
55 58 25 20 46 38 35 45 54 91 70 45
48 15.9
6
50 23.8
6
Dosage Unit: mg/kg/day
776 605 690 876 1552 830
159 130 112
77
203 126
4 7 11 5 9 7
888 339.5
6
134 42.9 6
7 2.6 6
Dosage Unit : mg/kg/day
855 999 1284 365
144 104 153
77
2 4 2 5
876 384.3
4
120 35.4 4
3 1.5 4
Dosage Unit: mg/kg/day
721 1042
733 878 1359 643
154 127 117
73
103 239
10 1
3 6 6 3
896 267.3
6
136 57.3 6
5 3.2 6
173 170 231
99 160 1291
354 461.0
6
169 137 186 273
191 58.2 4
176 138 140 143 222 287
184 59.7 6
482 268 451 349 235 462
374 106.3
6
440 666 421 310
459 149.3
4
339 451 339 436 407 240
369 78.9 6
21 23 12 11 17 45
22 12.5
6
288 155 235 223 152 278
222 58 6
14 44 18 20
24 13.6
4
252 391 314 171
282 93 4
29 6
61 39 42 65
40 21.7
6
163 295 212 264 238 155
221 55 6
03246
579
ANIMAL NUMBER
Appendix 4
Individual Clinical Chemistry Data
Hales
Day 37
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
AST/SGOT ALT/SGPT ALK PHOS
IU/L
IU/L
IU/L
GGT IU/L
SDH IU/L
CK IU/L
AMYLASE LIPASE
IU/L
IU/L
P AMYL U/L
Covance 6329-223 3M T-6295.7
Group: 4
105506 105507 105509 105511 105512 105522
MEAN S.D. N
Dose Level : 0.75
29 20 33 35 54 87 46 36 50 43 48 54
43 10.0
6
46 23.0
6
Dosage Unit: mg/kg/day
1772 564 967 798 808
1069
149 112
169 138
85 197
3 2 2 2 2 2
996 417.0
6
142 39.9 6
2 .4
6
154 164 436 143 329 473
283 149.7
6
675 536 626 539 348 409
522 124.7
6
38 9
21 35 20 30
26 10.9
6
341 329 380 311 236 247
307 55.9 6
003247
580
003248
Appendix 4
Individual Clinical Chemistry Data
Males
Day 37
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOSi T-6295) IN CYNOMOLGUS MONKEYS
ANIMAL NUMBER
CA MG/DL
I PHOS MG/DL
NA MMOL/L
K MMOL/L
CL MMOL/L
Group: 1
105508 105517 105519 105520 105526 105527
MEAN S.D. N
Group: 2
105514 105515 105516 105521
MEAN S.D. N
Group: 3
105505 105510 105518 105523 105524 105528
MEAN S.D. N
Dose Level : 0
10.3 11.0 10.6 10.5 10.4 10.7
7.0 6.7
7.0 6.8 7.4
5.1
10.6 .25 6
6.7 .80 6
Dose Level: 0 ,03
12.9 10.8 10.5 10.7
9.0 6.8 6.5 5.2
11.2 1.12 4
6.9 1.58
4
Dose Level : 0..15
11.2 11.2 11.4 10.9 10.4 10.6
5.4 7.4
6.4 6.9 8.3 6.3
11.0 .39 6
6.8 1.00
6
Dosage Unit: mg/kg/day
161 5.4 114 163 5.8 115 155 5.3 112 158 5.2 115 159 5.2 114 165 5.8 122
160 3.6 6
5.4 .28 6
115 3 6
Dosage Unit: mg/kg/day
180 6.6 121 162 6.2 114 160 5.1 116 158 5.2 111
165 10.1 4
5.8 .74
4
116 4 4
Dosage Unit: mg/kg/day
159 5.1 114 161 5.3 116 162 5.6 114 163 6.1 116 163 5.8 115 155 5.9 115
160
3.1 6
5.6 .38
6
115 6
581
Covance 6329-223 3M T-6295.7
Appendix 4
Individual Clinical Chemistry Data
Males
Day 37
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
ANIMAL NUMBER
CA MG/DL
I PHOS MG/DL
NA MMOL/L
K MMOL/L
CL MMOL/L
Group: 4
105506 105507 105509 105511 105512 105522
MEAN S.D. N
Dose Level : 0.75
10.6 10.6
10.9 10.6 11.3 11.6
7.8 5.1 6.1 5.2 7.8 7.6
10.9 .43
6
6.6 1.29
6
Dosage Unit: mg/kg/day
164 5.1 119 158 5.1 111 162 5.4 115 157 5.8 114
162 5.5 114 166 5.7 113
162 3.4 6
5.4 .29 6
114 2 6
Covance 6329-223 3M .T-6295.7
003249
582
ANIMAL NUMBER
Group: 1
105529 105530 105531 105535 105544 105549
MEAN S.D. N
Group : 2
105537 105541 105547 105550
MEAN S.D. N
Group: 3
105532 105538 105539 105545 105548 105552
MEAN S.D. N
GLU MG/DL
Appendix 4
Individual Clinical Chemistry Data
Females
Day 37
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
UN MG/DL
CREAT MG/DL
T PRO G/DL
ALB G/DL
GLOB G/DL
T BILI MG/DL
SBA UMOL/L
CHOL MG/DL
Covance 6329-223 3M T-6295.7
TRIG MG/DL
Dose Level : 0
50 21 86 25 57 25 43 16 59 27 55 18
58 14.7
6
22 4..4 6
Dose Level: 0. 03
87 20 65 22 65 18 50 25
67
15.2 4
21 3..0 4
Dose Level: 0. 15
53 22 60 21 72 15 64 17
48 20 60 25
60 8.4 6
20 3. 6 6
Dosage Unit: mg/kg/day
.9 9.2 1.3 9.0 1.2 8.5 1.1 9.6 1.1 10.6
.9 9.1
4.5 4.8 4.4 4.0
4.5 4.5
1.1 .16 6
9.3 .71
6
4.4 .26 6
Dosage Unit: mg/kg/day
1.1 9.1 4.4 1.1 9.3 4.4 1.0 8.4 4.4 1.1 9.2 4.7
1.1 .05 4
9.0 .41 4
4.5 .15 4
Dosage Unit: mg/kg/day
1.0 9.4 4.4
1.0 9.0 4.7 1.1 9.0 3.9 1.0 9.4 4.7
1.0 8.9 4.0 1.0 9.5 4.0
1.0 .04 6
9.2 .26 6
4.3 .37 6
4.7 4.2 4.1 5.6 6.1 4.6
4.9 .80 6
4.7 4.9 4.0 4.5
4.5 .39 4
5.0 4.3 5.1 4.7 4.9 5.5
4.9 .40 6
1.1 .4 .8 .3 .6 .2
.6 .34
6
.4 .8 .2 .5
.5 .25 4
.7 .4 .7 .6 .4 .5
.6 .14 6
8 106
64
8 154
56
7 160
65
7 183 123
8 127
63
8 151
56
8 147
.5 26..9 66
71 25..7
6
5 10 10 10
9 2..5 4
114 130 137 116
124 11. 1 4
60 78 50 69
64 12. 0
4
8 7 7 15 7 7
8 3. 2 6
146 105 149 162 114 123
133 22. 4 6
60 36 65 66 54 63
57 11. 3
6
003250
583
ANIMAL NUMBER
GLU MG/DL
Appendix 4
Individual Clinical Chemistry Data
Females
Day 37
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
UN MG/DL
CREAT MG/DL
T PRO G/DL
ALB G/DL
GLOB G/DL
T BILI MG/DL
SBA UMOL/L
CHOL MG/DL
Covance 6329-223 3M T-6295.7
TRIG MG/DL
Group: 4
105533 105534 105536 105540 105542 105551
MEAN S.D. N
Dose Level : 0.75
86 27 70 19 77 15 58 21
74 30 56 22
70 11.5
6
22 5.4 6
Dosage Unit: mg/kg/day
1.1 9.2 4.3 1.3 9.1 4.3 1.1 9.6 4.3 1.0 9.0 4.5 1.2 8.7 4.5
.9 8.9 4.4
1.1 .14
6
9.1 .31 6
4.4
.10 6
4.9 4.8 5.3 4.5 4.2 4.5
4.7 .38 6
.3 .3 .3 .4 .4 .7
.4 .15 6
9 136
68
6 130
59
7 102
51
6 121
61
7 138 110
6 113
46
7 123 1.2 14.1 66
66 23.0
6
003251
584
ANIMAL NUMBER
Appendix 4
Individual Clinical Chemistry Data
Females
Day 37
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
AST/SGOT ALT/SGPT ALK PHOS
IU/L
IU/L
IU/L
GGT IU/L
SDH IU/L
AMYLASE LIPASE
IU/L
IU/L
P AMYL U/L
Covance 6329-223 3m T-6295.7
1H
' GO e-
Group: 1
105529 105530 105531 105535 105544 105549
MEAN S.D. N
Group: 2
105537 105541 105547 105550
MEAN S.D. N
Group: 3
105532 105538 105539 105545 105548 105552
MEAN S.D. N
Dose Level: 0
28 36 54 108 33 51 44 38 44 38 60 85
44 12.1
6
59 30.2
6
Dose Level :: 0..03
49 73 68 81 29 51 49 76
49 15.9
4
70
13.3 4
Dose Level :: 0..15
33 35 41 69
26 49 45 125 35 70 38 60
36 6.6 6
68
30.9 6
Dosage Unit: mg/kg/day
209 88 400 98 330 80 583 138 351 164 298 44
3 9 4 7 3 5
362 125.6
6
102 42.9 6
5 2.4
6
Dosage Unit: mg/kg/day
210 170 257 65 193 54
301 64
3 2 3 5
240 48.7 4
88 54.7
4
3 1.3
4
Dosage Unit: mg/kg/day
286 103 459 90 130 73 219 43 423 70 396 76
1 4 2 2 5 4
319
129.0 6
76 20.3
6
3 1.5 6
109 205 156 180 274 518
240 146..6
6
287 761 165 301
378 262. 2
4
206 121 110 267 123 363
198 101.3
6
376 244 326 332 494 263
339 89..9 6
254 344 423 514
384 110. 9
4
364 387 305 533 317 580
414 115.1
6
14 27 38 11 18
0
18 13..2
6
232 107 188 186 279 169
194 58..2 6
24 15 23 50
28 15. 2
4
168 218 273 290
237 55. 5 4
41 50 36 41
0 36
34 17.4
6
172 200 198 282 179 350
230 70 6
003252
585
ANIMAL NUMBER
Appendix 4
Individual Clinical Chemistry Data
Females
Day 37
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
AST/SGOT ALT/SGPT ALK PHOS
IU/L
IU/L
IU/L
GGT IU/L
SDH IU/L
CK IU/L
AMYLASE LIPASE
IU/L
IU/L
1? AMYL U/L
Covance 6329-223 3M T-6295.7
Group: 4
105533 105534 105536 105540 105542 105551
MEAN S.D. N
Dose Level): 0.75
34 56 37 35 42 49 37 50 22 40 45 46
36 8.0 6
46 7.5 6
Dosage Unit : mg/kg/day
305 95 543 37 743 52 269 46
296 61 332 60
1 2 2 3 3 1
415 188.9
6
58 20.0
6
2 .9
6
153 766 352 413 130 174
331 242.1
6
404 485 341 394 233 383
373 83.3 6
32 15 20 27 24 21
23 5.9 6
261 298 203 215 119 284
230 66.0 6
003253
586
ANIMAL NUMBER
Group: 1
105508 105517 105519 105520 105526 105527
MEAN S.D. N
Group: 2
105514 105515 105516 105521
MEAN S.D. N
Group : 3
105505 105510 105518 105523 105524 105528
MEAN S.D. N
GLU MG/DL
Appendix 4
Individual Clinical Chemistry Data
Males
Day 62
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
UN MG/DL
CREAT MG/DL
T PRO G/DL
ALB G/DL
GLOB G/DL
T BILI MG/DL
SBA UMOL/L
CHOL MG/DL
Covance 6329-223 3M T-6295.7
TRIG MG/DL
Dose Level : 0
51 21 71 17
54 26 56 16 52 22 70 17
59 9.1 6
20 3..9 6
Dose Level : 0. 03
56 18 62 17
61 25 57 18
59 2.9 4
20 3.,7 4
Dose Level : 0. 15
58 16
59 14
83 16 84 19 62 22 54 24
67 13.3
6
18 3. 9 6
Dosage Unit: mg/kg/day
1.1 9.1 4.7 1.2 9.3 4.8 1.1 8.4 4.7 1.0 8.3 4.4 1.0 8.1 4.7 1.1 8.2 4.4
1.1 .08 6
8.6 .50 6
4.6 .17 6
Dosage Unit: mg/kg/day
1.2 8.6 4.9 1.3 9.9 4.8
1.0 8.4 4.2 1.3 9.3 5.0
1.2 .14 4
9.0 .69 4
4.7 .36 4
Dosage Unit: mg/kg/day
1.1 8.8 4.9 .8 8.1 4.1
1.3 9.0 4.8 1.2 9.0 5.4 1.3 8.4 4.4 1.2 9.2 4.3
1.2 .19 6
8.8 .42 6
4.6 .48
6
4.4 4.5 3.7 3.9 3.4 3.8
4.0 .42 6
3.7 5.1 4.2 4.3
4.3 .58 4
3.9 4.0 4.2 3.6 4.0 4.9
4.1 .44 6
1.3 1.0
.4 .8 .3 .3
.7 .42
6
.5 .4 .3 .3
.4 .10 4
.9 .3 .3 .3 .5 .5
.5 .23 6
8 11 11
8 8 10
9 1..5 6
132 179 178 124 147 158
153 23..0 6
13 8
10 9
10 2. 2 4
142 129
98 89
114 25.,1 4
9 8 10 13 10 9
10 1. 7 6
183 145 142 130 135 132
144 19. 7 6
67 97 44 63 48 56
62 19..0
6
57 73 71 41
60 14. 8
4
53 57 48 55 46 83
57 13. 4
6
003254
589
ANIMAL NUMBER
GLU MG/DL
Appendix 4
Individual Clinical Chemistry Data
Males
Day 62
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
UN MG/DL
CREAT MG/DL
T PRO G/DL
ALB G/DL
GLOB G/DL
T BILI MG/DL
SBA UMOL/L
CHOL MG/DL
Covance 6329-223 3M T-6295.7
TRIG MG/DL
Group: 4 Dose Level: 0.75
Dosage Unit: mg/kg/day
105506 105507
105509 105511 105512 105522
68 18 1.3 8.2 4.4 3.8 .3 10 106 70
95 23 1.4 9.1 4.5 4.6 .3
8 104
81
71 18 1.2 9.3 5.1 4.2 .3 14 117 62
67 17 1.1 8.8 4.3 4.5 .4
6 125
56
71 22 1.4 8.4 4.9 3.5 .2 11 144 96
70 17 1.2 8.8 5.7 3.1 .3
9 155
94
MEAN S.D. N
74 19 1.3 8.8 4.8 4.0 .3 10 125 76
10.6 2.6 .12 .41 .53 .59 .06
2.7 20.6 16.6
6666666666
003255
590
ANIMAL NUMBER
Appendix 4
Individual Clinical Chemistry Data
Males
Day 62
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
AST/SGOT ALT/SGPT ALK PHOS
IU/L
IU/L
IU/L
GGT IU/L
SDH IU/L
CK IU/L
AMYLASE LIPASE
IU/L
IU/L
P AMYL U/L
Covance 6329-223 3M T-6295.7
Group: 1
105508 105517 105519 105520 105526 105527
MEAN S.D. N
Group: 2
105514 105515 105516 105521
MEAN S.D. N
Group: 3
105505 105510 105518 105523 105524 105528
MEAN S.D. N
Dose Level :: 0
34 24 44 47 45 27 24 21
33 27 33 59
36 7.9 6
34 15..2
6
Dose Level:: 0..03
26 16 43 57
38 40 34 28
35 7.2 4
35 17. 5
4
Dose Level : 0..15
44 41
23 20 38 31 41 40 49 55 47 33
40 9.4 6
37 11. 7
6
Dosage Unit: mg/kg/day
709 512 742 848
1455 767
154 102 125
77
209 114
4 8 9 5 9 5
839 321.9
6
130 46.2 6
7 2..3 6
Dosage Unit: mg/kg/day
634 955 1125 287
121 109 147
87
5 5 2 5
750 369.9
4
116 25.0 4
4 1.,5 4
Dosage Unit: mg/kg/day
643 980 698 798 1181 535
143 134
109 80
106 194
10 1 3 6 9 2
806 237.8
6
128
39.4 6
5 3. 8 6
116 144 148
82 143 156
132 27..8 6
93 173 201 129
149 47.,7 4
127 157 133 175 152 173
153 19. 9 6
510 280 448 365 197 428
371 115..8
6
359 641 383 331
428 143. 3
4
305 442 327 436 354 203
344 89. 3 6
18 47
9 11 20 27
22 13..9
6
312 168 235 241 133 256
224 64.2 6
11 38
9 27
21 13. 8
4
214 390 295 182
270 92.9 4
14 0
32 24 23 26
20 11. 3
6
155 294 216 268 212 135
213 61.7 6
003256
591
ANIMAL NUMBER
Appendix 4
Individual Clinical Chemistry Data
Males
Day 62
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
AST/SGOT ALT/SGPT ALK PHOS
IU/L
IU/L
IU/L
GGT IU/L
SDH IU/L
CK IU/L
AMYLASE LIPASE
IU/L
IU/L
P AMYL U/L
Covance 6329-223 3M T-6295.7
Group : 4
105506 105507 105509 105511 105512 105522
MEAN S.D. N
Dose Level:: 0.75
26 28 27 31 36 64 43 38 34 34
35 63
34 6.3 6
43 16.2
6
Dosage Unit: mg/kg/day
1502 462 626 683 725 941
139 96
127 127
89 171
4 2 2 2 3 3
823 367.0
6
125 29.9
6
3 .8
6
155 163 300 169 189 244
203 57.2 6
657 496 593 516 340 390
499 119.4
6
38 14 15 20
8 40
22 13.4
6
349 312 367 299 237 243
301 53.4 6
003257
592
8SZC00
Appendix 4
Individual Clinical Chemistry Data
Males
Day 62
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
ANIMAL NUMBER
CA MG/DL
I PHOS MG/DL
NA MMOL/L
K MMOL/L
CL MMOL/L
Group: 1
105508 105517 105519 105520 105526 105527
MEAN S.D. N
Group: 2
105514 105515 105516 105521
MEAN S.D. N
Group: 3
105505 105510 105518 105523 105524 105528
MEAN S.D. N
Dose Level: 0
10.0 10.8 10.6 10.0
10.9 10.3
6.8 6.9 7.6 6.4
8.2 6.8
10.4 .39 6
7.1 .66 6
Dose Level : 0,.03
10.0 11.0 10.3 10.7
6.8 7.2
7.5 5.5
10.5 .44
4
6.8 .88 4
Dose Level : 0 .15
10.6 10.1 10.7
10.4 10.2 10.1
5.3 7.4
6.6 7.2 7.8 5.3
10.4 .26 6
6.6 1.08
6
Dosage Unit: mg/kg/day
159 4.7 116 161 5.7 118 157 5.7 121 158 5.4 120
159 5.0 121 165 5.8 123
160 2. 9 6
5.4 .44 6
120 2 6
Dosage Unit: mg/kg/day
160 5.1 117 185 7.0 136 159 5.2 116 161 5.2 120
166 12.,5 4
5.6 .92 4
122 9 4
Dosage Unit: mg/kg/day
158 4.9 121 154 4.9 115 161 6.1 120 162 5.1 121 161 5.8 120 164 5.3 126
160 3.,5 6
5.4 .50 6
120 3 6
593
Covance 6329-223 3M T-6295.7
Appendix 4
Individual Clinical Chemistry Data
Males
Day 62
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
ANIMAL NUMBER
CA MG/DL
I PHOS MG/DL
NA MMOL/L
K MMOL/L
CL MMOL/L
Group: 4
105506 105507 105509 105511 105512 105522
MEAN S.D. N
Dose Level : 0.75
10.0 10.3 10.1 10.1 11.1 11.4
7.6 6.2
5.9 5.1 8.7
7.3
10.5 .60 6
6.8 1.31
6
Dosage Unit: mg/kg/day
159 5.3 121 153 5.6 118 158 5.3 121 152 4.7 115 163 6.5 123 169 6.0 120
159 6.4 6
5.6 .63 6
120 2.8 6
Covance 6329-223 3M T-6295.7
003259
594
ANIMAL NUMBER
Group: 1
105529 105530 105531 105535 105544 105549
MEAN S.D. N
Group: 2
105537 105541 105547 105550
MEAN S.D. N
Group: 3
105532 105538 105539 105545 105548 105552
MEAN S.D. N
GLU MG/DL
Appendix 4
Individual Clinical Chemistry Data
Females
Day 62
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
UN 1MG/DL
CREAT MG/DL
T PRO G/DL
ALB G/DL
GLOB G/DL
T BILI MG/DL
SBA UMOL/L
CHOL MG/DL
Covance 6329-223 3M T-6295.7
TRIG MG/DL
Dose Level : 0
Dosage Unit: mg/kg/day
51 18 .9 8.5 4.4 4.1 69 22 1.2 8.6 4.5 4.1 61 25 1.2 8.5 4.5 4.0 47 16 1.2 9.5 4.2 5.3 67 24 1.2 9.8 4.0 5.8 46 22 1.0 9.3 4.5 4.8
.9 8 93 59
.3
9 152
59
.7
8 176
61
.4 9 227 185
.6
9 126
79
.3 10 156 70
57 10.2
6
21 3..5 6
1.1 .13 6
9.0 .57 6
4.4 .21 6
4.7 .75 6
.5 .24 6
9 155 .8 45..4
66
86 49..4
6
Dose Level : 0. 03
Dosage Unit: mg/kg/day
92 19 1.1 9.2 4.4 4.8 62 23 1.1 9.2 4.2 5.0
58 19 1.0 8.3 4.3 4.0 54 26 1.1 8.7 4.4 4.3
.4 7 126 .8 8 130 .3 15 140 .8 12 113
87 99 50 68
66 22 1.1 8.8 4.3 4.5
.6 10 127 76
17.3 3. 4 .05 .44 .10 .46 .26
3.7 11. 2 21. 5
444 44 4 44 4 4
Dose Level : 0. 15
Dosage Unit: mg/kg/day
53 20 1.2 9.2 4.7 4.5 .8 10 148 58
60 20 1.0 9.1 4.6 4.5 .4
9 113
33
76 18 1.1 8.9 4.0 4.9 .8
6 153
86
79 16 .9 9.0 4.4 4.6 .4 15 153 62
48 20 1.0 8.8 4.0 4.8 .5 13 112 75
57 24 1.0 9.1 4.0 5.1 .6
9 145
68
62 20 1.0 9.0 4.3 4.7 .6 10 137 64
12.6 2. 7 .10 .15 .33 .24 .18
3.2 19. 5 18. 0
6666666666
00S260
595
ANIMAL NUMBER
Group: 4
105533 105534 105536 105540 105542 105551
MEAN S.D. N
GLU MG/DL
Appendix 4
Individual Clinical Chemistry Data
Females
Day 62
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
UN MG/DL
CREAT MG/DL
T PRO G/DL
ALB G/DL
GLOB G/DL
T BILI MG/DL
SBA UMOL/L
CHOL MG/DL
Covance 6329-223 3M T-6295.7
TRIG MG/DL
Dose Level 0.75
Dosage Unit: mg/kg/day
88 19 1.2 8.8 4.4 4.4
.3
9 139
53
73 20 1.4 9.5 4.7 4.8 .5
9 142
63
75 14 1.2 9.6 4.3 5.3 .2
9 101
56
68 18 1.1 9.0 4.5 4.5 .4 12 148 78
74 19 1.2 8.5 4.2 4.3 .3
6 120
68
69 29 1.0 8.7 4.4 4.3
.4
8 111
50
74 7.2 6
20 5.0 6
1.2 .13 6
9.0 .44 6
4.4 .17 6
4.6 .39 6
.4 .10
6
9 127 1.9 18.9 66
61 10.5
6
003261
596
ANIMAL NUMBER
Appendix 4
Individual Clinical Chemistry Data
Females
Day 62
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
AST/SGOT ALT/SGPT ALK PHOS
IU/L
IU/L
IU/L
GGT IU/L
SDH IU/L
CK IU/L
AMYLASE LIPASE
IU/L
IU/L
P AMYL U/L
Covance G329-223 3M T-6295.7
Group: 1
105529 105530 105531 105535 105544 105549
MEAN S.D. N
Group: 2
105537 105541 105547 105550
MEAN S.D. N
Group: 3
105532 105538 105539 105545 105548 105552
MEAN S.D. N
Dose Level:: 0
35 49 38 49 32 45 39 39 41 49 40 86
38 3.4 6
53 16. 7
6
Dose Level:: 0.03
55 77 41 98 33 60 51 73
45 9.9 4
77 15. 8
4
Dose Level :: 0 .15
35 31 46 87
29 43 48 105 33 41 33 54
37 7.8 6
60 29. 3
6
Dosage Unit: mg/kg/day
245 86 331 92 321 83 665 170 290 159 308 48
2 6 5 6
2 4
360 152.5
6
106 47.7 6
4 1..8 6
Dosage Unit: mg/kg/day
241 150 239 67
186 53 297 66
3 2
4 7
241 45.3 4
84 44.5
4
4 2..2 4
Dosage Unit: mg/kg/day
233 99
451 89
129 72 202 39 428 68 386 81
2 5 3 4 4 4
305 134.0
6
75 20.8
6
4 1. 0 6
182 226 490 294 245 138
262 123. 6
6
316 334 182 270
276 67. 9 4
302 124 121 253 142 224
194 76. 1 6
352 272 346 330 498 251
342 86..9 6
244 296 410 483
358 108..3
4
365 381 271 528 310 605
410 129.,7
6
11 5
38 5
26 0
14 14.7
6
219 118 201 191 286 170
198 55 6
27 0
12 38
19 16.7
4
166 196 270 280
228 55 4
41 35 30 11
0 53
28 19.6
6
172 208 180 283 182 380
234 82 6
003262
597
ANIMAL NUMBER
Appendix 4
Individual Clinical Chemistry Data
Females
Day 62
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
AST/SGOT ALT/SGPT ALK PHOS
IU/L
IU/L
IU/L
GGT IU/L
SDH IU/L
CK IU/L
AMYLASE LIPASE
IU/L
IU/L
P AMYL U/L
Covance 6329-223 3M T-6295.7
Group : 4
105533 105534 105536 105540 105542 105551
MEAN S.D. N
Dose Level: 0.75
29 39 35 41 31 44 31 52
19 33 43 42
31 7. 8 6
42 6..2 6
Dosage Unit : mg/kg/day
285 96 506 39 755 52 240 48 250 52
351 62
2 2 1 2 2 2
398 200.5
6
58 20.0
6
2 .4
6
172 285 204 483 113 200
243 130,.1
6
414 503 340 434 241 377
385 89.4 6
30 41 23 34 18 15
27 9.9 6
271 317 204 240 161 283
246 56 6
003263
598
003264
Appendix 4
Individual Clinical Chemistry Data
Females
Day 62
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
ANIMAL NUMBER
CA MG/DL
I PHOS MG/DL
NA MMOL/L
K MMOL/L
CL MMOL/L
Group: 1
105529 105530 105531 105535 105544 105549
MEAN S.D. N
Group: 2
105537 105541 105547 105550
MEAN S.D. N
Group: 3
105532 105538 105539 105545 105548 105552
MEAN S.D. N
Dose Level : 0
9.7 9.6 10.4 10.3 9.9 10.3
5.9 6.2
5.9 6.5 5.7
5.5
10.0 .34 6
6.0 .36 6
Dose Level : 0..03
9.7 10.2 10.0
9.8
4.8 4.2
4.4 4.8
9.9 .22 4
4.6 .30 4
Dose Level: 0 .15
9.7 10.0
8.8 10.1
9.9 9.4
5.2 4.8 5.3 4.3 5.2 5.8
9.6 .48 6
5.1 .51 6
Dosage Unit: mg/kg/day
151 4.7 114 159 6.3 114 166 6.0 123 167 6.1 125
160 5.5 119 168 6.0 125
162 6. 5 6
5.8 .59 6
120 5 6
Dosage Unit: mg/kg/day
159 4.9 120 163 5.6 119 156 4.8 118 160 5.6 123
160 2. 9 4
5.2 .43 4
120 2 4
Dosage Unit: mg/kg/day
166 6.5 127 156 5.4 121
160 5.6 127 158 5.5 121 158 4.7 122 162 5.1 121
160 3. 6 6
5.5 .60 6
123 3 6
599
Covance 6329-223 3M T-6295.7
Appendix 4
Individual Clinical Chemistry Data
Females
Day 62
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
ANIMAL NUMBER
CA MG/DL
I PHOS MG/DL
NA MMOL/L
K MMOL/L
CL MMOL/L
Group: 4
105533 105534 105536 105540 105542 105551
MEAN S.D. N
Dose Level : 0.75
9.9 10.8 11.0
9.4
10.4 10.0
5.0 4.6 5.1 5.2 4.7 5.4
10.2 .60 6
5.0 .30 6
Dosage Unit: mg/kg/day
157 5.4 118 163 6.9 121
160 6.2 119 157 5.8 121 164 5.1 119 165 5.3 123
161 3.5 6
5.8 .67 6
120 1 6
Covance 6329-223 3M T-6295.7
003265
600
ANIMAL NUMBER
Group : 1
105508 105517 105519 105520 105526 105527
MEAN S.D. N
Group : 2
105514 105515 105516 105521
MEAN S.D. N
Group : 3
105505 105510 105518 105523 105524 105528
MEAN S.D. N
GLU MG/DL
Appendix 4
Individual Clinical Chemistry Data
Males
Day 91
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
UN 1MG/DL
CREAT MG/DL
T PRO G/DL
ALB G/DL
GLOB G/DL
T BILI MG/DL
SBA UMOL/L
CHOL MG/DL
Covance 6329-223 3m T-6295.7
TRIG MG/DL
Dose Level : 0
53 19 64 19 57 29 54 19
56 17
74 20
60 8.0 6
20 4. 3 6
Dose Level : 0. 03
57 19 74 14 64 26 59 19
64 7.6 4
20 4. 9 4
Dose Level : 0. 15
65 15 70 14
108 19 78 16 75 26 53 22
75 18.5
6
19 4. 6 6
Dosage Unit: mg/kg/day
1.0 8.7 4.7 1.3 9.1 4.8 1.1 8.3 4.7 1.0 8.4 4.7
1.1 8.3 4.8 1.3 9.2 5.0
1.1 .14 6
8.7 .40 6
4.8 .12 6
Dosage Unit: mg/kg/day
1.2 9.0 1.2 10.3
1.1 8.5 1.6 10.5
5.1 5.2
5.1 5.9
1.3 .22 4
9.6 .98 4
5.3 .39 4
Dosage Unit: mg/kg/day
1.2 8.7 5.1 1.0 9.0 4.9
1.3 9.0 5.0 1.0 9.1 5.2 1.4 8.8 4.8 1.2 9.2 5.0
1.2 .16 6
9.0 .19 6
5.0 .14 6
4.0 4.3 3.6 3.7 3.5 4.2
3.9 .33 6
3.9 5.1 3.4 4.6
4.2 .75 4
3.6 4.1 4.0 3.9 4.0 4.2
4.0 .21 6
1.2 1.1
.5 .8 .3 .4
.7 .38
6
.6 .3 .4 .4
.4 .13 4
.8 .3 .2 .3 .5 .5
.4 .22
6
6 119
61
8 177 101
9 170
56
8 132
81
7 151
43
9 177
66
8 154 1..2 24..6
66
68 20..4
6
7 143 8 132 7 109 8 119
8 126 6 14.,9
44
51 60 64 42
54 9. 8 4
8 6 8 9 14 8
9 2. 7 6
173 163 125 139 136 161
150 18. 8 6
49 56 38 48 68 44
50 10. 4
6
003266
601
ANIMAL NUMBER
GLU MG/DL
Appendix 4
Individual Clinical Chemistry Data
Males
Day 91
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
UN MG/DL
CREAT MG/DL
T PRO G/DL
ALB G/DL
GLOB G/DL
T BILI MG/DL
SBA UMOL/L
CHOL MG/DL
Covance 6329-223 3M T-6295.7
TRIG MG/DL
Group : 4 Dose Level : 0.75
Dosage Unit: mg/kg/day
105506 105507 105509 105511 105512 105522
63 20 1.6 9.5 5.5 4.0 111 21 1.6 9.8 5.1 4.7
75 18 1.3 9.8 5.4 4.4 62 18 1.1 9.0 4.7 4.3
63 20 1.4 9.0 5.3 3.7 65 18 1.3 9.5 5.5 4.0
.3
9 107
88
.2 8 80 57
.3 17 90 59
.3
9 105
56
.2 10 147 68
.3 7 141 108
MEAN S.D. N
73 19 1.4 9.4 5.2 4.2 .3 10 112 73
19.1 1.3 .19 .36 .31 .35 .05
3.6 27.0 21.0
6666666666
003267
602
ANIMAL NUMBER
Appendix 4
Individual Clinical Chemistry Data
Males
Day 91
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
AST/SGOT ALT/SGPT ALK PHOS
IU/L
IU/L
IU/L
GGT IU/L
SDH IU/L
CK IU/L
AMYLASE LIPASE
IU/L
IU/L
P AMYL U/L
Covance 6329-223 3M T-6295.7
Group: 1
105508 105517 105519 105520 105526 105527
MEAN S.D. N
Group: 2
105514 105515 105516 105521
MEAN S.D. N
Group: 3
105505 105510 105518 105523 105524 105528
MEAN S.D. N
Dose Level:: 0
41 25 48 45 46 31 27 24
36 24 36 63
39 7.7
6
35 15. 8
6
Dose Level:: 0..03
26 16
35 38 37 46 43 142
35 7.0 4
60 55..8
4
Dose Level:: 0..15
46 39 25 21
41 37 34 38 45 87 61 49
42 12.2
6
45 22. 4
6
Dosage Unit : mg/kg/day
706 533 782 901 1408 863
152 102 130
82 226 126
4 6 11 7 9 5
866 296.2
6
136 50.1 6
7 2,.6 6
Dosage Unit: mg/kg/day
692 824 1306 335
127 113 181 104
5 4 2 5
789 401.7
4
131 34.5 4
4 1..4 4
Dosage Unit: mg/kg/day
710 1097
645 724 1271
660
143 160 111
76 108 244
11 1 4
11 4
3
851 265.3
6
140 58.6 6
6 4. 3 6
222 164 166 120 167 168
168 32..4 6
130 153 189 227
175 42.,5 4
164 137 140 129 194 220
164 36. 2 6
525 275 437 377 251 487
392 111..8
6
386 741 396 338
465 185..6
4
356 501 324 454 394 235
377 94. 9 6
18 23
0 20 53 84
33 30..3
6
10 134
30 18
48 57..9
4
38 5
25 25 12 56
27 18. 3
6
359 184 261 275 186 325
265 71.2 6
254 492 322 205
318 125.4
4
200 365 240 306 266 174
258 70.1 6
S92TC00
603
ANIMAL NUMBER
Appendix 4
Individual Clinical Chemistry Data
Males
Day 91
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT {PFOS; T-6295) IN CYNOMOLGUS MONKEYS
AST/SGOT ALT/SGPT ALK PHOS
IU/L
IU/L
IU/L
GGT IU/L
SDH IU/L
CK IU/L
AMYLASE LIPASE
IU/L
IU/L
1? AMYL U/L
Covance 6329-223 3M T-6295.7
Group: 4
105506 105507 105509 105511 105512 105522
MEAN S.D. N
Dose Level: 0.75
29 21 30 34 40 75 43 35 31 34 41 65
36 6..3 6
44 21.0
6
Dosage Unit: mg/kg/day
1624 463 563 566 726 900
154
108 122 118
95 166
3 2 2 1
2 2
807 428.6
6
127 27.4 6
2 .6
6
133 174 305 204 157 308
214 75.7 6
730 556 409 345 353 414
468 149.1
6
63 18 26 35 15 38
32 17.5
6
433 381 417 320 263 287
350 70.4 6
003269
604
Appendix 4
Individual Clinical Chemistry Data
Males
Day 91
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
ANIMAL NUMBER
CA MG/DL
I PHOS MG/DL
NA MMOL/L
K MMOL/L
CL MMOL/L
Group: 1
105508 105517 105519 105520 105526 105527
MEAN S.D. N
Group: 2
105514 105515 105516 105521
MEAN S.D. N
Group: 3
105505 105510 105518 105523 105524 105528
MEAN S.D. N
Dose Level : 0
9.7
11.0 9.8
10.2
9.5 11.4
6.9 6.3 6.6 6.7
6.9 7.4
10.3 .77
6
6.8 .37 6
Dose Level : 0..03
9.8 10.1 10.6 11.6
6.9 6.7 7.5 5.8
10.5 .79 4
6.7 .70 4
Dose Level : 0..15
11.0 11.4
10.0 10.7 10.4 10.3
5.8 8.2
6.6 6.5 8.0 5.8
10.6 .51 6
6.8 1.05
6
Dosage Unit: mg/kg/day
158 4.7 115 160 5.1 117 154 4.7 112 156 5.2 114
159 4.9 119 174 6.2 127
160 7.1 6
5.1 .56 6
117 5 6
Dosage Unit: mg/kg/day
163 4.6 117 173 6.8 125 163 5.1 117 169 6.4 123
167 4.9 4
5.7 1.04
4
120 4
4
Dosage Unit: mg/kg/day
160 4.8 117 169 5.6 129
159 5.3 115 160 5.7 122 162 5.7 110 155 5.3 112
161 4.6 6
5.4 .35 6
118 7 6
Covance 6329-223 3M T-6295.7
0032
O
605
Appendix 4
Individual Clinical Chemistry Data
Males
Day 91
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
ANIMAL NUMBER
CA MG/DL
I PHOS MG/DL
NA MMOL/L
K MMOL/L
CL MMOL/L
Group: 4
105506 105507 105509 105511 105512 105522
MEAN S.D. N
Dose Level : 0.75
10.7 11.2 10.4 10.3 11.2 11.1
7.1 6.7
5.6 5.0 6.6 7.5
10.8 .41 6
6.4 .94 6
Dosage Unit: mg/kg/day
170 5.1 125 160 5.8 114 158 5.1 117 158 5.0 116 163 5.2 115 167 6.1 114
163 5.0 6
5.4 .45 6
117 4 6
Covance 6329-223 3M T-6295.7
003271
606
ANIMAL NUMBER
Group: 1
105529 105530 105531 105535 105544 105549
MEAN S.D. N
Group: 2
105537 105541 105547 105550
MEAN S.D. N
Group: 3
105532 105538 105539 105545 105548 105552
MEAN S.D. N
GLU MG/DL
Appendix 4
Individual Clinical Chemistry Data
Females
Day 91
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
UN MG/DL
CREAT MG/DL
T PRO G/DL
ALB G/DL
GLOB G/DL
T BILI MG/DL
SBA UMOL/L
CHOL MG/DL
Covance 6329-223 3M T-6295.7
TRIG MG/DL
Dose Level : 0
Dosage Uni t : mg/kg/day
48 20 1.0 8.8 4.7 4.1
.7
8 99 65
78 22 1.3 9.8 5.4 4.4
.3
6 189
65
95 21 1.2 8.5 4.5 4.0
.4 10 182
61
58 15 1.2 9.4 4.4 5.0 .3
7 217
88
78 22 1.1 9.7 4.4 5.3 .5
9 136
57
42 18 1.1 9.3 4.7 4.6 .3
9 171
65
66 20.5
6
20 2..7
6
Dose Level : 0,.03
1.2 .10 6
9.2 .51 6
4.7 .38 6
Dosage Unit: mg/kg/day
4.6 .51 6
.4 .16
6
8 166 1.5 42.0 66
67 10.9
6
81 18 1.1 9.0 4.7 4.3
.3
7 114
53
51 22 1.2 9.8 4.7 5.1
.9
7 143
81
61 22 1.0 8.1 4.3 3.8 .4
8 149
50
80 26 1.1 9.0 4.6 4.4 .4 10 129 60
68 14.7
4
22 3..3 4
1.1 .08 4
9.0 .69 4
4.6 .19 4
4.4 .54 4
.5 .27
4
8 134 1.4 15.6 44
61 14.0
4
Dose Level: 0,.15
Dosage Unit: mg/kg/day
62 15 1.1 9.2 4.8 4.4 .6
7 153
42
55 20 1.1 9.3 4.9 4.4
.3
7 122
35
74 18 1.0 8.7 3.8 4.9 .4
8 143
77
49 24 1.0 8.9 4.6 4.3 .5 22 151 67
45 17 1.0 9.0 4.3 4.7
.4 10 125
43
74 26 1.0 9.3 4.2 5.1
.4
8 143
72
60 20 1.0 9.1 4.4 4.6 .4 10 140 56
12.4 4. 2 .05 .24 .41 .32 .10
5.8 13.1 18.0
6666666666
003272
607
ANIMAL NUMBER
GLU MG/DL
Appendix 4
Individual Clinical Chemistry Data
Females
Day 91
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
UN MG/DL
CREAT MG/DL
T PRO G/DL
ALB G/DL
GLOB G/DL
T BILI MG/DL
SBA UMOL/L
CHOL MG/DL
Covance 6329-223 3M T-6295.7
TRIG MG/DL
Group: 4 Dose Level : 0.75
Dosage Unit: mg/kg/day
105533 105534 105536 105540 105542 105551
84 22 1.2 9.8 4.8 5.0 .3
9 142
62
89 18 1.4 9.5 5.0 4.5
.3
6 131
76
89 14 1.2 9.6 4.5 5.1 .3
6 65 51
63 20 1.4 10.0 5.2 4.8
.3 13 105
53
93 32 1.3 9.1 4.5 4.6
.3
7 115
78
56 26 .9 8.8 4.6 4.2 .5 24 109 42
MEAN S.D. N
79 22 1.2 9.5 4.8 4.7
.3 11 111
60
15.5 6.3 .19 .45 .29 .33 .08
7.0 26.6 14.4
6666666666
003273
608
ANIMAL NUMBER
Appendix 4
Individual Clinical Chemistry Data
Females
Day 91
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
AST/SGOT ALT/SGPT ALK PHOS
IU/L
IU/L
IU/L
GGT IU/L
SDH IU/L
CK IU/L
AMYLASE LIPASE
IU/L
IU/L
P AMYL U/L
Covance 6329-223 3M T-6295.7
Group : 1 Dose Level !: 0
Dosage Unit: mg/kg/day
105529 105530 105531 105535 105544 105549
36 55 220 81 57 78 322 123 35 43 292 84 53 38 583 161
40 38 274 164 44 74 284 50
3 188 9 1481 6 128 7 2407
5 146 4 368
387 292 410 350 510 269
8 264 0 144 45 259 10 224 25 327 0 198
MEAN S.D. N
44 9.1 6
54 17.9
6
329 128.7
6
110 46.5
6
6 786 370
2..2 947..2
87..4
666
15 17. 5
6
236 62
6
Group: 2 Dose Level:: 0..03
Dosage Unit: mg/kg/day
105537 105541
105547 105550
39 72 219 220
39 80 238 73
30 50 168 53
64 114 307
67
2 247 269 2 250 348 3 165 454 11 217 487
23 190 2 249
23 330 25 306
MEAN S.D. N
43 14.6
4
79 26.6
4
233 57.5 4
103 78.3
4
4 220 390 4. 4 39. 4 99. 8
444
18 10. 9
4
269 62 4
Group: 3 Dose Level: 0.15
Dosage Unit: mg/kg/day
105532 105538 105539 105545 105548 105552
30 34 235 37 57 531 23 52 157 56 153 229 38 54 404 40 54 390
98 85 69 42 68 82
1 196 447 130 245
4 149 426
41 261
3 107 290
26 213
2 345 520
25 319
7 230 329
0 214
7 227 640
18 443
MEAN
37 67 324 74
4 209 442
40 282
S.D.
11.1
42.8
140.3
19.2
2.5
81.8
127.6
46.1
87
N 666666666
co,'
vF
609
ANIMAL NUMBER
Appendix 4
Individual Clinical Chemistry Data
Females
Day 91
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
AST/SGOT ALT/SGPT ALK PHOS
IU/L
IU/L
IU/L
GGT IU/L
SDH IU/L
CK IU/L
AMYLASE LIPASE
IU/L
IU/L
P AMYL U/L
Covance 6329-223 3M T-6295.7
Group: 4
105533 105534 105536 105540 105542 105551
MEAN S.D. N
Dose Level: 0.75
35 43
38 34 33 42 31 41
20 40 50 71
34 9..8 6
45 13. 0
6
Dosage Unit: mg/kg/day
296 106 447 43 668 54 294 52
280 58 346 63
1 1 2 2
2 2
388 150.1
6
63 22.3
6
2 .5
6
1132 476 367 141 105 276
416 377. 0
6
389 482 343 480 225 353
379 96.5 6
35 0
18 35 16 12
19 13.6
6
281 338 221 292 169 279
263 59 6
003275
610
000276
Appendix 4
Individual Clinical Chemistry Data
Females
Day 91
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
ANIMAL NUMBER
CA MG/DL
I PHOS MG/DL
NA MMOL/L
K MMOL/L
CL MMOL/L
Group: 1
105529 105530 105531 105535 105544 105549
MEAN S.D. N
Group: 2
105537 105541 105547 105550
MEAN S.D. N
Group: 3
105532 105538 105539 105545 105548 105552
MEAN S.D. N
Dose Level: 0
10.2
11.1 10.3 11.0
8.1 10.7
5.5 6.0 4.8 6.8 5.6 5.5
10.2 1.11 6
5.7 .66 6
Dose Level: 0..03
9.7
11.5 8.8
10.9
4.5 3.6
4.5 4.0
10.2 1.21 4
4.2 .44 4
Dose Level: 0 .15
9.7 10.7
9.2 10.1 10.4
9.9
5.4 5.0 5.4 4.1 5.2 6.0
10.0 .53 6
5.2 .63 6
Dosage Unit: mg/kg/day
151 5.0 109 168 6.7 125 160 5.1 116 166 5.7 125
160 4.8 118 162 6.1 117
161 5.9 6
5.6 .74
6
118 6 6
Dosage Unit: mg/kg/day
156 4.6 110 170 6.5 122 154 4.5 113 165 5.4 124
161 7.5 4
5.2 .93 4
117 6 4
Dosage Unit: mg/kg/day
160 5.2 116 161 6.2 121
156 5.3 116 156 5.6 118 160 5.7 125 165 6.3 125
160 3.4
6
5.7 .45 6
120 4 6
611
Covance 6329-223 3M T-6295.7
Appendix 4
Individual Clinical Chemistry Data
Females
Day 91
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
ANIMAL NUMBER
' CA MG/DL
I PHOS MG/DL
NA MMOL/L
K MMOL/L
CL MMOL/L
Group: 4
105533 105534 105536 105540 105542 105551
MEAN S.D. N
Dose Level : 0.75
10.4
10.5 10.7 11.5
10.6 9.7
4.9 4.2 5.0 5.8
5.3 5.2
10.6 .58 6
5.1 .53 6
Dosage Unit: mg/kg/day
159 5.4 122 165 6.2 124 160 5.9 114 170 6.6 117
163 5.8 118 157 5.1 115
162 4.7 6
5.8 .54 6
118 3 6
Covance 6329-223 3M T-6295.7
LLznm
612
ANIMAL NUMBER
GLU MG/DL
Appendix 4
Individual Clinical Chemistry Data
Males
Day 153
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T--6295) IN CYNOMOLGUS MONKEYS
UN MG/DL
CREAT MG/DL
'T PRO G/DL
ALB G/DL
GLOB G/DL
T BILI MG/DL
SBA UMOL/L
CHOL MG/DL
TRIG MG/DL
Covance 6329-223 3M T-6295.7
HDL MG/DL
Group: 1
105508 105517 105519 105520 105526 105527
MEAN S.D. N
Group: 2
105514 105515 105516 105521
MEAN S.D. N
Group: 3
105505 105510 105518 105523 105524 105528
MEAN S.D. N
Dose Level: 0
57 22 74 16 52 25 55 19 60 20 65 20
60 8.0 6
20 3..0 6
Dose Level: 0..03
56 18
63 19 60 22 66 17
61 4.3 4
19 2. 2
4
Dose Level: 0..15
58 21 62 16 71 24 74 17 65 27 48 25
63 9.4
6
22 4.,5 6
Dosage Unit: mg/kg/day
1.0 7.7 4.6 1.2 8.9 5.0 1.1 7.9 4.7 1.0 8.2 4.6 1.2 8.1 5.0 1.3 8.6 4.9
1.1 .12 6
8.2 .45 6
4.8 .19 6
Dosage Unit: mg/kg/day
1.1 8.3 5.0 1.3 9.6 5.2 1.1 7.9 5.0 1.5 9.4 5.5
1.2 .19 4
8.8 .83 4
5.2 .24 4
Dosage Unit: mg/kg/day
1.1 8.4 5.3 .9 8.2 4.7
1.3 9.3 5.4 1.1 9.6 4.7 1.4 8.5 5.0 1.1 8.6 4.8
1.2 .18 6
8.8 .55 6
5.0 .31 6
3.1 3.9 3.2 3.6 3.1 3.7
3.4 .34 6
3.3 4.4 2.9 3.9
3.6 .66 4
3.1 3.5 3.9 4.9 3.5 3.8
3.8 .61 6
1.2 1.2
.4 .6 .4 .3
.7 .41 6
.5 .3 .4 .4
.4 .08 4
.7 .3 .4 .2 .6 .6
.5 .20
6
8 11 12 11
9 10
10 1.5 6
115 178 183 124 147 178
154 29.9 6
7 136 8 127 8 117 6 98
7 120 1.0 16.3 44
11 7
10 9
11 14
10 2.3 6
191 135 145 129 136 157
149 22.8 6
68 82 39 78 42 54
60 18.3
6
49 97 49 44
60 24.9
4
49 69 73 74 64 59
65 9.5 6
58 77 84 57 70 67
69 10.6
6
52 45 42 43
46 4.5 4
74 60 56 49 53 36
55 12.5
6
003278
613
ANIMAL NUMBER
GLU MG/DL
Appendix 4
Individual Clinical Chemistry Data
Males
Day 153
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
UN MG/DL
CREAT MG/DL
T PRO G/DL
ALB G/DL
GLOB G/DL
T BILI MG/DL
SBA UMOL/L
CHOL MG/DL
TRIG MG/DL
Covance 6329-223 3M T-6295.7
HDL MG/DL
Group : 4
105506 105507 105509 105511 105512 105522
MEAN S.D. N
Dose Level : 0.75
80 22 98 23 60 21 55 17
91 19 72 19
76 17.0
6
20 2.2
6
Dosage Unit: mg/kg/day
1.6 9.4 5.4 1.4 9.0 4.8 1.2 9.0 4.2 1.0 9.0 4.6 1.2 8.7 5.1 1.3 9.2 5.4
1.3 .20 6
9.0 .23 6
4.9 .48 6
4.0 4.2 4.8 4.4 3.6 3.8
4.1 .43 6
.2 11 57 51 16
.2 14 29 29
9
.3 17 65 89 18
.3 8 75 41 25
.2 24 76 58 27
.2 13 87 95 20
.2 14 65 60 19
.05
5.5 20.3 26.3
6
66666
003279
614
ANIMAL NUMBER
Appendix 4
Individual Clinical Chemistry Data
Males
Day 153
26-WEEK CAPSULE 'rOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
AST/SGOT ALT/SGPT ALK PHOS
IU/L
IU/L
IU/L
GGT IU/L
SDH IU/L
CK IU/L
AMYLASE LIPASE
IU/L
IU/L
P AMYL U/L
Covance 6329-223 3M T-6295.7
Group: 1
105508 105517 105519 105520 105526 105527
MEAN S.D. N
Group: 2
105514 105515 105516 105521
MEAN S.D. N
Group: 3
105505 105510 105518 105523 105524 105528
MEAN S.D. N
Dose Level:: 0
29 31 34 51 37 29 23 22
30 30
33 95
31 4.9 6
43 27. 3
6
Dose Level :: 0 .03
22 13 35 59
35 43 28 28
30 6.3 4
36 19. 8
4
Dose Level:: 0.15
43 72 28 43
33 40 20 36 50 75 63 63
40 15.7
6
55 17. 2
6
Dosage Unit: mg/kg/day
723
490 666 842
1370 659
156 125 128
79
238 126
2 2
8 3 1 1
792 305.3
6
142 53.1 6
3 2. 6
6
Dosage Unit: mg/kg/day
606 778 1093 258
132 109 163
88
4 3
1 1
684 348.2
4
123 32.2 4
2 1.,5 4
Dosage Unit: mg/kg/day
740 848 720 897 1241 673
160 143
129 70
121 262
4 1 2 1 7 8
853 207.5
6
148 63.8 6
4 3. 1 6
157 130 194 135 184 191
165 28..5 6
92 144 188 108
133 42,.6 4
218 178 201 122 213 225
193 38. 4 6
527 290 457 408 226 446
392 112. 8
6
403 713 420 344
470 165. 2
4
348 514 356 479 402 475
429 69. 9 6
28 27 12 20 12 39
23 10..5
6
14 100
19 31
41 40..0
4
30 9
36 28 36 860
166 339. 9
6
377 203 285 307 174 309
276 74 6
273 502 360 220
339 123
4
211 392 274 346 282 365
312 67, 6
003280
615
ANIMAL NUMBER
Appendix 4
Individual Clinical Chemistry Data
Males
Day 153
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
AST/SGOT ALT/SGPT AtK PHOS
IU/L
IU/L
IU/L
GGT IU/L
SDH IU/L
CK IU/L
AMYLASE LIPASE
IU/L
IU/L
P AMYL U/L
Covance 6329-223 3M T-6295.7
Group: 4
105506 105507 105509 105511 105512 105522
MEAN S.D. N
Dose Level: 0.75
28 24
31 39 52 85 44 33 40 46 37 85
39 8. 8 6
52 26. 6
6
Dosage Uni t : mg/ kg/day
1262 239 902 415 377
683
168
109 88 98
70 141
2 2 5 2 2 2
646 384.1
6
112 36.1 6
2 1.2
6
180 219 954 207 267 285
352 297. 5
6
758 499 504 494 439 406
517 124.5
6
61 9
25 33 25 36
32 17.2
6
475 359 371 340 346 296
364 59.9 6
003281
616
003282
Appendix 4
Individual Clinical Chemistry Data
Males
Day 153
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOSj T-6295) IN CYNOMOLGUS MONKEYS
ANIMAL NUMBER
CA MG/DL
I PHOS MG/DL
NA MMOL/L
K MMOL/L
CL MMOL/L
Group: 1
105508 105517 105519 105520 105526 105527
MEAN S.D. N
Group: 2
105514 105515 105516 105521
MEAN S.D. N
Group: 3
105505 105510 105518 105523 105524 105528
MEAN S.D. N
Dose Level: 0
9.0 11.0 10.3
9.8
9.9 10.8
6.6 6.2 6.8 6.9
6.9 6.3
10.1 .73 6
6.6 .31 6
Dose Level: 0,.03
10.2 11.3 10.4 11.2
6.6 6.6 7.2 4.7
10.8 .56 4
6.3 1.09
4
Dose Level: 0 .15
9.6 10.1
11.3 10.9
9.9 10.3
5.7 7.2 6.9 6.2 8.6 6.5
10.4 .64 6
6.8 1.01
6
Dosage Unit: mg/kg/day
154 4.7 116 160 5.4 116 150 5.3 110 151 5.3 112
163 5.8 121 164 6.1 119
157 6.1 6
5.4 .48 6
116 4 6
Dosage Unit: mg/kg/day
154 5.0 113 163 6.1 114 159 4.9 118 161 6.1 122
159 3.9
4
5.5 .67 4
117 4 4
Dosage Unit: mg/kg/day
161 5.7 120 154 4.8 119 159 6.0 114 158 5.3 116
161 5.6 109 154 5.8 112
158 3.2 6
5.5 .43 6
115 4 6
617
Covance 6329-223 3M T-6295.7
Appendix 4
Individual Clinical Chemistry Data
Males
Day 153
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
ANIMAL NUMBER
` CA MG/DL
I PHOS MG/DL
NA MMOL/L
K MMOL/L
CL MMOL/L
Group: 4
105506 105507 105509 105511 105512 105522
MEAN S.D. N
Dose Level : 0.75
11.4 10.4
9.5 10.5 11.4 11.3
7.9 6.7 4.3 5.9 9.1 7.2
10.8 .76 6
6.8 1.66
6
Dosage Unit: mg/kg/day
171 6.6 128 150 6.4 111 153 4.8 107 153 5.8 108 160 5.1 109 163 6.2 114
158 7.9
6
5.8 .73 6
113 7 6
Covance 6329-223 3M T-6295.7
003283
618
ANIMAL NUMBER
GLU MG/DL
Appendix 4
Individual Clinical Chemistry Data
Females
Day 153
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
UN 1MG/DL
CREAT MG/DL
T PRO G/DL
ALB G/DL
GLOB G/DL
T BILI MG/DL
SBA UMOL/L
CHOL MG/DL
TRIG MG/DL
Covance 6329-223 3M T-6295.7
HDL MG/DL
Group: 1
105529 105530 105531 105535 105544 105549
MEAN S.D. N
Group: 2
105537 105541 105547 105550
MEAN S.D. N
Group: 3
105532 105538 105539 105545 105548 105552
MEAN S.D. N
Dose Level : 0
48 21 74 22
62 25 57 16
57 23 47 15
58 9.9 6
20 4.,0 6
Dose Level : 0. 03
46 18 70 25 72 12 68 24
64 12.1
4
20 6..0 4
Dose Level : 0. 15
49 20 53 23 62 18 59 24 58 23 60 27
57 4.9 6
22 3.,1 6
Dosage Unit: mg/kg/day
.9 7.6 4.3 1.3 9.6 5.6 1.2 8.2 4.6 1.2 9.2 4.4 1.1 9.4 4.6 1.1 9.3 4.8
1.1 .14 6
8.9 .80 6
4.7 .47
6
Dosage Unit: mg/kg/day
1.0 8.6 4.4 1.3 8.9 4.6
.9 8.3 3.8 1.1 8.5 4.7
1.1 .17
4
8.6 .25 4
4.4 .40 4
Dosage Unit: mg/kg/day
1.1 9.2 5.1 1.0 8.5 4.6 1.2 8.8 4.2 1.0 8.3 4.7 1.1 8.7 4.3 1.0 9.0 4.1
1.1 .08
6
8.8 .33 6
4.5 .37 6
3.3 4.0 3.6 4.8 4.8 4.5
4.2 .63 6
4.2 4.3 4.5 3.8
4.2 .29 4
4.1 3.9 4.6 3.6 4.4 4.9
4.2 .48 6
1.0 .3 .6 .4 .6 .3
.5 .27
6
.4 1.0
.2 .5
.5 .34 4
.6 .3 .4 .5 .4 .6
.5 .12 6
7 9 9 9 9 11
9 1.3 6
80 175 177 226 143 175
163 48..5 6
53 65 70 175 59 56
80 47..1
6
6 9 10 9
8 1.7 4
102 128
82 127
110 22.,1 4
61 123
65 77
82 28.,5
4
8 7 9 12 15 8
10 3.1 6
133 100 144 136 107 162
130 23. 2 6
54 57 72 83 86 60
69 13. 7
6
39 73 64 56 42 81
59 16..8
6
43 61 41 42
47 9..5 4
33 37 56 37 48 34
41 9. 2 6
003284
619
ANIMAL NUMBER
GLU MG/DL
Appendix 4
Individual Clinical Chemistry Data
Females
Day 153
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
UN MG/DL
CREAT MG/DL
T PRO G/DL
ALB G/DL
GLOB G/DL
T BILI MG/DL
SBA UMOL/L
CHOL MG/DL
TRIG MG/DL
Covance 6329-223 3M T-6295.7
HDL MG/DL
Group: 4 Dose Level : 0.75
Dosage Unit: mg/kg/day
105533 105534 105536 105540 105542
105551
81 21 1.2 9.6 5.1 4.5
.3 15 100
62 25
74 12 1.4 9.1 4.6 4.5 .3
9 128 69 23
70 13 1.1 9.0 3.9 5.1 .2
8 62 44 20
62 15 1.1 8.7 4.6 4.1
.3
8 80 67 16
87 18 1.1 8.4 4.2 4.2 .4
9 77 84 25
46 26 1.0 8.6 4.6 4.0 .4 43 99 55 28
MEAN S.D. N
70 18 1.2 8.9 4.5 4.4 .3 15 91 64 23
14.6
5.3 .14
.43
.41
.40
.08
13.8
23.1
13.5
4
66666666666
S82C00
620
ANIMAL NUMBER
Appendix 4
Individual Clinical Chemistry Data
Females
Day 153
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
AST/SGOT ALT/SGPT ALK PHOS
IU/L
IU/L
IU/L
GGT IU/L
SDH IU/L
CK IU/L
AMYLASE LIPASE
IU/L
IU/L
P AMYL U/L
Covance 6329-223 3M T-6295.7
Group: 1
105529 105530 QS 105531 105535 105544 105549
MEAN S.D. N
Group: 2
105537 105541 105547 105550
MEAN S.D. N
Group: 3
105532 105538 105539 105545 105548 105552
MEAN S.D. N
Dose Level: 0
52 159 33 82 30 51 31 48 37 44 33 79
36 8.2 6
77 43. 3
6
Dose Level:; 0,.03
54 88 33 70 17 18 46 146
38 16.2
4
80 52. 8
4
Dose Level:! 0..15
36 47
31 53 24 38 61 131 26 75 38 52
36 13.4
6
66 34. 1
6
Dosage Unit: mg/kg/day
175 78 305 115 277 82 593 171
266 176 272 53
3 1 2 2 1 2
315 143.3
6
112 51.2 6
2 .8
6
Dosage Unit: mg/kg/day
221 254
233 70 280 42 312 68
3 2 2 1
262 42.2 4
108 97.8 4
2 .8
4
Dosage Unit: mg/kg/day
259 100 498 78 169 68 228 38 401 67 292 78
2 3 3 2 1 8
308 120.9
6
72 20.3
6
3
2.5 6
192 377 156 362 155 169
235 105..0
6
395 293
79 253
255 131..7
4
268 118 201 330 126 412
242 116. 5
6
395 296 383 361 499 302
373 74..3 6
249 358 394 513
378 108..8
4
371 405 280 494 310 733
432 165. 5
6
11
-
45 8
25 0
18 17..7
5
285 175 255 244 342 232
256 55..7 6
25 3
11 33
18 13..5
4
182 276 302 341
275 67. 7 4
23 45 34 28
0 19
25 15. 2
6
212 264 211 322 208 541
293 129. 4
6
98200
621
ANIMAL NUMBER
Appendix 4
Individual Clinical Chemistry Data
Females
Day 153
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
AST/SGOT ALT/SGPT ALK PHOS
IU/L
IU/L
IU/L
GGT IU/L
SDH IU/L
CK IU/L
AMYLASE LIPASE
IU/L
IU/L
P AMYL U/L
Covance 6329-223 3M T-6295.7
Group : 4
105533 105534 105536 105540 105542 105551
MEAN S.D. N
Dose Level: 0.75
33 45 73 42 34 41 30 40 22 62 46 60
40 18. 1
6
48 10. 0
6
Dosage Unit : mg/kg/day
285 107 359 44 616 47 230 44 216 57
310 66
1 2 7 2 1
1
336 146.9
6
61 24.2
6
2 2.3 6
297 3173
99 139 154 306
695 1217. 1
6
374 554 344 404 232 373
380 104.1
6
33 6
23 36 31 30
26 10.9
6
284 406 238 270 178 308
281 76.1 6
003287
622
003288
Appendix 4
Individual Clinical Chemistry Data
Females
Day 153
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
ANIMAL NUMBER
CA MG/DL
I PHOS MG/DL
NA MMOL/L
K MMOL/L
CL MMOL/L
Group: 1
105529 105530 105531 105535 105544 105549
MEAN S.D. N
Group: 2
105537 105541 105547 105550
MEAN S.D. N
Group: 3
105532 105538 105539 105545 105548 105552
MEAN S.D. N
Dose Level: 0
9.4 11.7 10.1 10.7 10.1
9.4
5.2 6.0 5.8 5.8 5.2 5.8
10.2 .87 6
5.6 .34
6
Dose Level: 0,.03
8.4 10.9 10.0 10.0
4.0 4.9 3.0 4.6
9.8 1.04
4
4.1 .84 4
Dose Level: 0,.15
9.5 9.3 9.7
9.9 10.4 10.2
5.0 3.8 5.7
4.0 5.1 6.3
9.8 .42 6
5.0 .96
6
Dosage Unit: mg/kg/day
144 4.7 107 169 6.6 124 155 5.8 116 163 6.9 125 159 5.6 125 161 6.5 116
158 8.5 6
6.0 .81 6
119 7 6
Dosage Unit: mg/kg/day
148 5.1 108 163 6.1 118 151 5.3 113 159 5.8 124
155 6.9 4
5.6 .46 4
116 6 4
Dosage Unit: mg/kg/day
153 4.7 110 152 5.3 118 154 5.8 115 152 5.7 114 158 4.8 120 154 5.9 118
154 2.2 6
5.4 .52 6
116 3 6
623
Covance 6329-223 3M T-6295.7
Appendix 4
Individual Clinical Chemistry Data
Females
Day 153
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
ANIMAL NUMBER
CA MG/DL
I PHOS MG/DL
NA MMOL/L
K MMOL/L
CL MMOL/L
Group: 4
105533 105534 105536 105540 105542 105551
MEAN S.D. N
Dose Level : 0.75
10.6 11.7
10.5 10.1
10.6 9.7
5.0 6.0 5.0 4.0
4.3 5.3
10.5 .67
6
4.9 .71
6
Dosage Unit: mg/kg/day
158 5.3 116 166 7.1 114 153 7.1 116 153 5.9 111 161 6.5 124 156 5.7 114
158 5.0 6
6.3 .75 6
116 4 6
Covance 6329-223 3M T-6295.7
003289
624
ANIMAL NUMBER
GLU MG/DL
Appendix 4
Individual Clinical Chemistry Data
Males
Day 182
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
UN MG/DL
CREAT MG/DL
T PRO G/DL
ALB G/DL
GLOB G/DL
T BILI MG/DL
SBA UMOL/L
CHOL MG/DL
TRIG MG/DL
Covance 6329-223 3M T-6295.7
HDL MG/DL
Group: 1
105508 105517 105519 105520 105526 105527
MEAN S.D. N
Group: 2
105514 105515 105516 105521
MEAN S.D. N
Group : 3
105505 105510 105518 105523 105524 105528
MEAN S.D. N
Dose Level : 0
64 18 68 14 51 25 59 16 57 21 64 17
60 6.1 6
18 3. 9 6
Dose Level : 0. 03
62 18 77 12 59 27 57 16
64 9.1 4
18
6..3 4
Dose Level : 0. 15
70 15 71 13 83 18 68 16 72 19 57 20
70 8.3 6
17 2. 6 6
Dosage Unit: mg/kg/day
1.1 8.5 4.9 1.2 9.1 4.9 1.0 7.7 4.6
.8 7.7 4.5 1.2 8.4 5.1 1.2 8.1 4.6
1.1 .16 6
8.2 .54 6
4.8 .23 6
Dosage Unit: mg/kg/day
1.2 8.6 4.9 1.2 9.1 4.8
1.0 8.0 4.8 1.4 9.5 5.5
1.2 .16 4
8.8 .65 4
5.0 .34 4
Dosage Unit: mg/kg/day
1.1 8.6 5.2
.8 8.2 4.4 1.2 8.5 5.0 1.1 9.0 5.2 1.3 8.4 4.8 1.1 8.2 4.7
1.1 .17 6
8.5 .30 6
4.9 .31 6
3.6 4.2 3.1 3.2 3.3 3.5
3.5 .40 6
3.7 4.3 3.2 4.0
3.8 .47 4
3.4 3.8 3.5 3.8 3.6 3.5
3.6 .17 6
.9 .8 .5 .5 .3 .4
.6 .23 6
.3 .2 .4 .3
.3 .08 4
.5 .2 .3 .3 .4 .4
.4 .10 6
5 127 7 166 5 186 6 112 6 165 6 158
6 152 ,8 27..5
66
5 135 4 104 5 98 5 102
5 110 .5 17..0
44
8 190 5 136 7 119 5 137 5 151 5 149
6 147 1. 3 24. 0 66
45 55 37 35 41 55
45 8..7 6
28 35 41 27
33 6..6 4
22 51 31 45 32 35
36 10. 4
6
56 66 82 53 67 54
63 11
6
47 42 38 41
42 3 4
73 53 48 39 42 32
48 14
6
003290
625
ANIMAL NUMBER
GLU MG/DL
Appendix 4
Individual Clinical Chemistry Data
Males
Day 182
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
UN MG/DL
CREAT MG/DL
T PRO G/DL
ALB G/DL
GLOB G/DL
T BILI MG/DL
SBA UMOL/L
CHOL MG/DL
TRIG MG/DL
Covance 6329-223 3M T-6295.7
HDL MG/DL
Group : 4
105506 a 105507 105511 105512 105522
MEAN S.D. N
Dose Level : 0.75
107 28 93 22
66 23 78 27 67 16
76 12.6
4
22 4.5 4
Dosage Unit: mg/kg/day
1.8 9.2 4.4 1.4 9.3 4.8
.9 8.0 4.2 1.3 8.8 5.2 1.4 9.8 5.4
1.2 .24 4
9.0 .77
4
4.9 .53 4
4.8 4.5 3.8 3.6 4.4
4.1 .44 4
.2 58 67 75 11
.2 28 28 22
8
.2 18 59 36 20
.2 7 38 19 10
.3 19 69 44 15
.2 18 48 30 13
.05
8.6 18.8 11.8
5
44444
a Unscheduled sacrifice on Day 179.
003291
626
ANIMAL NUMBER
Appendix 4
Individual Clinical Chemistry Data
Males
Day 182
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
AST/SGOT ALT/SGPT ALK PHOS
IU/L
IU/L
IU/L
GGT IU/L
SDH IU/L
CK IU/L
AMYLASE LIPASE
IU/L
IU/L
P AMYL U/L
Covance 6329-223 3M T-6295.7
Group: 1 Dose Level;: 0
Dosage Unit: mg/kg/day
105508 105517
105519 105520
105526 105527
28 32 756 169
2 122 524
15 373
35 52 420 126
5 106 308
37 210
41 27 628 149 10 526 440 19 281
23 26 776 72
3 207 388
30 298
30
26 1322
266
7 159 243
22 194
33 69 510 118 11 140 454 51 327
MEAN S.D. N
32 6.2 6
39 17. 9
6
735 318.7
6
150 65.6 6
6 210 393 3,,7 158,.7 102.,8 666
29 13. 4
6
280 68 6
Group: 2 Dose Level ;; 0 .03
Dosage Unit : mg/kg/day
105514 105515 105516 105521
19 16 548 136
34 35 552 100
29
34 1085
182
27 31 233 87
2 93 379 6 219 646 2 143 391 4 96 354
15 260 37 443
15 329 27 224
MEAN S.D. N
27 6.2 4
29 8. 8 4
604 353.5
4
126 42.6 4
4 138 442
1. 9
58..8
136. 5
444
24 10. 6
4
314 96 4
Group: 3 Dose Level ; 0 .15
Dosage Unit: mg/kg/day
105505 105510 105518 105523 105524 105528
30 39 650 171
4 118 412
36 234
21 20 634 133
3 102 431
7 333
39 51 558 115
7 116 336
36 256
22 58 697 95
3 101 472
36 337
50
69 1035
125
13 296 397
37 277
51 43 557 250
5 314 240
27 184
MEAN
36 47 688 148
6 174 381
30 270
S.D.
13.3
16. 9
178.3
55.8
3. 8 101.,5
82. 3
11. 8
59,
N 666666666
Li
N
627
ANIMAL NUMBER
Appendix 4
Individual Clinical Chemistry Data
Males
Day 182
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
AST/SGOT ALT/SGPT ALK PHOS
IU/L
IU/L
IU/L
GGT IU/L
SDH IU/L
CK IU/L
AMYLASE LIPASE
IU/L
IU/L
P AMYL U/L
Covance 6329-223 3M T-6295.7
Group: 4
105506 a 105507 105511 105512 105522
MEAN S.D. N
Dose Level: 0.75
73 29 30 46 41 25 36 44
30 73
34 5. 3 4
47 19.7
4
Dosage Unit : mg/kg/day
876 134 208 110 344 101 422 71
581 132
10 2 4 3 2
389 155.7
4
104
25.3 4
3
1.0 4
4040 192 101 175 258
182 64. 5 4
738 474 524 379 408
446 65.3 4
67 17 27 32 68
36 22.2
4
432 344 339 297 299
320 25.2 4
a Unscheduled sacrifice on Day 179.
003293
628
003294
Appendix 4
Individual Clinical Chemistry Data
Males
Day 182
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
ANIMAL NUMBER
CA MG/DL
I PHOS MG/DL
NA MMOL/L
K MMOL/L
CL MMOL/L
Group: 1
105508 105517 105519 105520 105526 105527
MEAN S.D. N
Group: 2
105514 105515 105516 105521
MEAN S.D. N
Group : 3
105505 105510 105518 105523 105524 105528
MEAN S.D. N
Dose Level : 0
10.1
10.9 10.2
9.7
10.5 9.9
6.8 5.5 6.5 6.2 7.7
5.6
10.2 .43 6
6.4 .82 6
Dose Level: 0,.03
9.9 9.9 9.9 10.3
5.7 5.3 7.1 4.9
10.0 .20 4
5.8 .96 4
Dose Level: 0 .15
10.8 9.7
10.2 10.2 10.1
9.7
5.0 6.5 6.1 6.3 7.5 5.8
10.1 .41
6
6.2 .82 6
Dosage Unit: mg/kg/day
156 4.7 111 160 5.3 113 149 5.2 112 151 5.2 109
159 5.2 112 150 4.9 110
154 4.8 6
5.1 .23 6
111 1 6
Dosage Unit: mg/kg/day
157 5.1 112 155 4.8 107 154 4.7 109 157 5.4 108
156 1.5 4
5.0 .32 4
109 2 4
Dosage Unit: mg/kg/day
157 4.8 112 152 4.9 113 147 5.4 107 158 5.2 112 158 5.2 110 150 4.8 106
154 4.7 6
5.0 .25 6
110 2 6
629
Covance G329-223 3M T-6295.7
Appendix 4
Individual Clinical Chemistry Data
Males
Day 182
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
ANIMAL NUMBER
CA MG/DL
I PHOS MG/DL
NA MMOL/L
K MMOL/L
CL MMOL/L
Group: 4
105506 a 105507 105511 105512 105522
MEAN S.D. N
Dose Level : 0.75
10.6 10.1
9.6 10.3
11.1
6.9 7.2 4.4 6.1 6.7
10.3 .62 4
6.1 1.22
4
Dosage Unit: mg/kg/day
157 7.5 111
144 5.5
99
152 5.2 111
157 5.6 109
158 5.4 106
153 6.4
4
5.4 .17 4
106 5 4
a Unscheduled sacrifice on Day 179.
Covance 6329-223 3M T-6295.7
00329S
630
ANIMAL NUMBER
Group: 1
105529 105530 105531 105535 105544 105549
MEAN S.D. N
Group: 2
105537 105541 105547 105550
MEAN S.D. N
Group : 3
105532 105538 105539 105545 105548 105552
MEAN S.D. N
GLU MG/DL
Appendix 4
Individual Clinical Chemistry Data
Females
Day 182
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T--6295) IN CYNOMOLGUS MONKEYS
UN MG/DL
CREAT MG/DL
T PRO G/DL
ALB G/DL
GLOB G/DL
T BILI MG/DL
SBA UMOL/L
CHOL MG/DL
TRIG MG/DL
Covance 6329-223 3M T-6295.7
HDL MG/DL
Dose Level: 0
Dosage Unit: mg/kg/day
35 23 58 21 68 22 44 16 75 22 65 14
58 15.2
6
20 3..7 6
Dose Level : 0,.03
62 18 58 18 53 19 44 25
54 7.8 4
20 3..4 4
Dose Level: 0,.15
.8 8.0 4.4 1.3 9.6 5.5 1.2 8.4 4.5 1.2 9.4 4.7 1.2 9.5 4.4 1.0 8.7 4.6
1.1 .18
6
8.9 .66 6
4.7 .42 6
Dosage Unit: mg/kg/day
1.1 9.1 4.6 1.2 9.3 4.7
.8 7.6 3.7 1.0 8.5 4.6
1.0 .17
4
8.6 .76 4
4.4 .47 4
Dosage Unit: mg/kg/day
3.6 4.1 3.9 4.7 5.1 4.1
4.2 .55 6
4.5 4.6 3.9 3.9
4.2 .38 4
.9 .3 .4 .3 .4 .2
.4 .25 6
.5 .8 .2 .5
.5 .24 4
5 87 6 181 6 176 6 226 7 143 6 149
6 160 .6 46.5
66
4 99 6 143 4 109 7 138
5 122 1.5 21.6 44
46 48 74 72 55 44
56 13.3
6
53 66 31 45
49 14.7
4
32 71 59 60 43 73
56 16.0
6
33 54 42 37
42 9.1 4
80 17 1.1 9.2 5.0 4.2 .4 10 130 44 25
63 17 .9 8.6 4.6 4.0 .3
7 98 26 34
66 18 1.1 9.0 4.3 4.7
.4
6 154 68 58
56 21 1.0 8.4 4.7 3.7 .5 11 137 56 38
55 16 .9 8.5 4.3 4.2 .3
7 108 37 38
66 24 1.0 9.6 4.0 5.6 .3
7 149 61 25
64 9.0 6
19 3.,1 6
1.0 .09 6
8.9 .47 6
4.5 .35 6
4.4 .67 6
.4 .08 6
8 129 2.0 22.3 66
49 15.8
6
36 12.1
6
96ZC00
631
ANIMAL NUMBER
GLU MG/DL
Appendix 4
Individual Clinical Chemistry Data
Females
Day 182
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
UN MG/DL
CREAT MG/DL
T PRO G/DL
ALB G/DL
GLOB G/DL
T BILI MG/DL
SBA UMOL/L
CHOL MG/DL
TRIG MG/DL
Covance 6329-223 3M T-6295.7
HDL MG/DL
Group : 4 Dose Level : 0.75
Dosage Unit: mg/kg/day
105533 105534 105536 105540 105542 105551
78 23 1.2 9.1 4.8 4.3 74 22 1.4 9.4 4.8 4.6 86 12 1.2 9.9 4.0 5.9 67 18 1.1 9.1 4.7 4.4
80 22 1.1 9.2 4.4 4.8 55 25 .9 8.8 4.6 4.2
.2 5 88 .2 6 93 .2 5 67 .3 12 76 .2 4 66 .4 11 102
46 22 77 15 34 21 45 11
67 26 50 31
MEAN S.D. N
73 11.0
6
20 4.7 6
1.2 .16 6
9.2 .37 6
4.6 .31 6
4.7 .63 6
.2 .08
6
7 82 53 21
3.4 14.7 15.8
7
6666
ANIMAL NUMBER
Appendix 4
Individual Clinical Chemistry Data
Females
Day 182
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
AST/SGOT ALT/SGPT ALK PHOS
IU/L
IU/L
IU/L
GGT IU/L
SDH IU/L
CK IU/L
AMYLASE LIPASE
IU/L
IU/L
P AMYL U/L
Covance 6329-223 3M T-6295.7
Group: 1
105529 105530 105531 105535 105544 L05549
MEAN S.D. N
Group: 2
105537 105541 105547 105550
MEAN S.D. N
Group: 3
105532 105538 105539 105545 105548 105552
MEAN S.D. N
Dose Level :: 0
91 262 30 55 25 42 37 56 39 61 26 47
41 25.0
6
87 85. 9
6
Dose Level: 0,.03
58 61 34 60
26 55 50 111
42
14.6 4
72 26. 3
4
Dose Level: 0..15
34 38 29 32
21 43 59 126 42 35
35 43
37
13.0 6
53 36. 1
6
Dosage Unit: mg/kg/day
169 86 274 113 243 81 554 172 237 182
222 48
10 2 4
5 7 2
283 137.1
6
114 53.3 6
5 3,,1 6
Dosage Unit: mg/kg/day
207 260 218 70
296 50 236 65
3 2
5 15
239 39.7 4
111 99.5 4
6 6. 0 4
Dosage Unit : mg/kg/day
228 102 363 69 118 74 219 41 303 65 295 76
5 5 2 3 14 13
254 85.3 6
71 19.7
6
7 5. 2 6
151 197
84 287 134 422
212 123..4
6
2745 209 147 190
823 1281..8
4
167 95
238 321 109 164
182 84. 7 6
350 282 407 351 530 345
378 84..6 6
254 337 347 496
358 100. 7
4
372 430 302 514 335 683
439 140. 9
6
19 16 103 14 41
0
32 37,.1
6
14 12
8 41
19 15. 0
4
56 52 42 29
0 17
33 21. 6
6
252 158 274 234 355 275
258 64,.1 6
184 252 265 341
260 64. 4 4
204 272 232 323 226 505
294 111. 7
6
003298
633
ANIMAL NUMBER
Appendix 4
Individual Clinical Chemistry Data
Females
Day 182
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
AST/SGOT ALT/SGPT ALK PHOS
IU/L
IU/L
IU/L
GGT IU/L
SDH IU/L
CK IU/L
AMYLASE LIPASE
IU/L
IU/L
P AMYL U/L
Covance 6329-223 3M T-6295.7
Group : 4
105533 105534 105536 105540 105542 105551
MEAN S.D. N
Dose Level: 0.75
33 43 33 34 31 38 25 37
32 59 44 53
33 6. 2 6
44 9. 9 6
Dosage Unit: mg/kg/day
243 107
245 43 659 58 217 48 212 63 320 65
4 1 4 2
5 4
316 172.4
6
64 22.7
6
3 1.5 6
253 203 189 296 515 251
284 119.3
6
337 467 408 399 279 358
375 64.9 6
29 9
19 68 42 20
31 21.2
6
256 338 277 252 213 300
273 43.1 6
003299
634
003300
Appendix 4
Individual Clinical Chemistry Data
Females
Day 182
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
ANIMAL NUMBER
CA MG/DL
I PHOS MG/DL
NA MMOL/L
K MMOL/L
CL MMOL/L
Group: 1
105529 105530 105531 105535 105544 105549
MEAN S.D. N
Group: 2
105537 105541 105547 105550
MEAN S.D. N
Group: 3
105532 105538 105539 105545 105548 105552
MEAN S.D. N
Dose Level : 0
9.1
11.1 9.8
10.6 10.2 10.1
4.5 6.1 5.2 6.1 5.7 4.1
10.2 .68 6
5.3 .84 6
Dose Level : 0,.03
9.2 10.9
9.1 9.4
4.2 4.2 5.0 4.3
9.6 .84 4
4.4 .39 4
Dose Level: 0,.15
9.7 9.6 9.8 9.9 9.6 10.0
5.4 3.3 5.8 3.7 4.6 5.9
9.8 .16 6
4.8 1.10
6
Dosage Unit: mg/kg/day
142 4.5 102 159 6.1 112
155 5.1 108 159 5.0 112 160 5.4 115 158 5.7 115
156 6.8 6
5.3 .56 6
111 5 6
Dosage Unit: mg/kg/day
148 3.9 106 163 6.1 114
149 4.5 110 149 4.5 107
152 7.2 4
4.8 .94 4
109 3 4
Dosage Unit: mg/kg/day
155 4.8 110 149 4.4 108 155 5.1 110 156 5.1 112
151 5.0 113 158 5.5 110
154
3.3 6
5.0 .37 6
110 1 6
635
Covance 6329-223 3M T-6295.7
Appendix 4
Individual Clinical Chemistry Data
Females
Day 182
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
ANIMAL NUMBER
CA MG/DL
I PHOS MG/DL
NA MMOL/L
K MMOL/L
CL MMOL/L
Group: 4
105533 105534 105536 105540 105542 105551
MEAN S.D. N
Dose Level : 0.75
9.3 10.8 10.9
9.9
11.0 10.0
4.7 5.3 5.3 4.4
6.6 5.0
10.3 .69 6
5.2 .76 6
Dosage Uni t: mg/ kg/day
148 4.3 109 160 6.6 113 162 5.9 112 155 5.0 106 158 5.7 107 155 4.9 113
156 4.9 6
5.4 .82 6
110 3 6
Covance 6329-223 3M T-6295.7
TOCCOO
636
ANIMAL NUMBER
GLU MG/DL
APPENDIX 4
Individual Clinical Chemistry Data
Males
Day 217
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS
UN MG/DL
CREAT MG/DL
T PRO G/DL
ALB G/DL
GLOB G/DL
T BILI MG/DL
SBA UMOL/L
CHOL MG/DL
Covance 6329-223 3M study No. T-6295.7
TRIG MG/DL
HDL MG/DL
Group : 1 Dose Level : 0
Dosage Unit: mg/kg/day
105520 105526
59 12 1.1 7.9 4.6 3.3
.6 11 112
43 49
55 19 1.0 8.2 4.7 3.5 .4 13 152 44 67
MEAN S.D. N
57 16 1.0 8.0 4.6 3.4 .5 12 132 44 58
2.8 4.9 .07 .21 .07 .14 .14
1.4 28.3
.7 12.7
22222222222
Group : 3 Dose Level : 0.15
Dosage Unit: mg/kg/day
105505 105523
61 17 .8 8.7 5.1 3.6 .8 16 184 37 75 78 17 1.0 9.3 5.1 4.2 .5 16 131 41 47
MEAN S.D. N
70 17 .9 9.0 5.1 3.9 .6 16 158 39 61
12.0
.0 .14 .42 .00 .42 .21
.0 37.5
2.8 19.8
22222222222
Group: 4 Dose Level : 0.75
Dosage Unit: mg/kg/day
105511 105522
70 13 1.0 8.7 4.3 4.4 76 16 1.1 8.7 4.8 3.9
.6 12 140 46 33 .6 17 134 92 22
MEAN S.D. N
73 14 1.0 8.7 4.6 4.2 .6 14 137 69 28
4.2 2.1 .07 .00 .35 .35 .00
3.5 4.2 32.5 7.8
22222222222
ooaao2
ANIMAL NUMBER
APPENDIX 4
Individual clinical Chemistry Data
Males
Day 217
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-62951 IN CYNOMOLGUS
AST/SGOT ALT/SGPT ALK PHOS
IU/L
IU/L
IU/L
GGT IU/L
SDH IU/L
CK IU/L
AMYLASE LIPASE
IU/L
IU/L
Covance 6329-223 3M Study No. T-6295.7
P AMYL U/L
Group: 1
105520 105526
MEAN S.D. N
Group : 3
105505 105523
MEAN S.D. N
Group: 4
105511 105522
MEAN S.D. N
Dose Level: 0
19 23 24 28
22 3.5 2
26 3.5 2
Dose Level: 0.15
43 45 31 42
37 8.5 2
44 2.1 2
Dose Level: 0.75
36 28 29 68
32 4.9 2
48 28.3
2
Dosage Unit: mg/kg/day
709 1156
62 237
3 4
932 316.1
2
150 123.7
2
4 .7
2
Dosage Unit: mg/kg/day
917 186 669 89
11 13
793 175.4
2
138 68.6 2
12
1.4 2
Dosage Unit: mg/kg/day
538 127 499 159
1 2
518 27.6 2
143 22.6 2
2 .7
2
84 194
139 77.8 2
177 146
162 21.9 2
177 223
200 32.5 2
400 276
338 87.7 2
424 484
454 42.4 2
543 467
505 53.7 2
30 41
36 7.8 2
292 209
250 58.7 2
48 45
46 2.1 2
244 332
288 62.2 2
23 53
38 21.2
2
362 329
346 23.3 2
003303
APPENDIX 4
Individual clinical Chemistry Data
Males
Day 217
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS
ANIMAL NUMBER
CA MG/DL
I PHOS MG/DL
NA MMOL/L
K MMOL/L
CL MMOL/L
Group: i
105520 105526
MEAN S.D. H
Group : 3
105505 105523
MEAN S.D. N
Group : 4
105511 I05S22
MEAN S.D. N
Dose Level: 0
9.6 10.4
5.5 7.1
10.0 .57 2
6.3 1.13
2
Dose Level : 0 .15
11.5 10.4
6.6 6.6
11.0 .78 2
6.6 .00 2
Dose Level: 0..75
10.6 10.9
5.4 7.0
10.8 .21 2
6.2 1.13
2
Dosage Unit: mg/kg/day
150 4.6 112 154 5.3 110
152 2.8
2
5.0 .49 2
111 1.4 2
Dosage Unit: mg/kg/day
156 5.5 110 154 5.1 106
155
1.4 2
5.3 .28 2
108 2.8 2
Dosage Unit: mg/kg/day
157 5.4 112 161 5.5 110
159 2.8 2
5.4 .07 2
111 1.4 2
Covance 6329-223 3M Study No. T-6295.7
ANIMAL NUMBER
GLU MG/DL
APPENDIX 4
Individual Clinical Chemistry Data
Females
Day 217
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS
UN MG/DL
CREAT MG/DL
T PRO G/DL
ALB G/DL
GLOB G/DL
T BILI MG/DL
SBA UMOL/L
CHOL MG/DL
Covance 6329-223 3M Study No. T-6295.7
TRIG MG/DL
HDL MG/DL
Group : 1
105529 105549
Dose Level : 0
51 19 67 12
Dosage Unit: mg/kg/day
.7 8.3 4.4 .9 8.9 4.7
3.9 4.2
.7 13 86 108 .1 15 152 37
33 74
MEAN S.D. N
59 16
.8 8.6 4.6 4.0
.4 14 119 72 54
11.3 4.9 .14 .42 .21 .21 .42
1.4 46.7 50.2 29.0
222 22222222
Group: 3 Dose Level : 0.15
Dosage Unit: mg/kg/day
105539 105552
76 19 1.0 8.6 4.1 4.5 .6 14 142 59 61 77 16 1.0 8.8 4.0 4.8 .6 13 148 52 26
MEAN S.D. N
76 18 1.0 8.7 4.0 4.6
.6 14 145
56 44
.7 2.1 .00 .14 .07 .21 .00
.7 4.2 4.9 24.7
222 222222 22
Group : 4 Dose Level : 0.75
Dosage Unit: mg/kg/day
105533 105542
82 21 1.1 9.6 5.0 4.6 68 25 .8 9.0 4.2 4.8
.6 14 135 .5 24 131
62 25 93 42
MEAN S.D. N
75 23 1.0 9.3 4.6 4.7
.6 19 133
78 34
9.9 2.8 .21 .42 .57 .14 .07
7.1 2.8 21.9 12.0
22 2 2 2 2 222 22
003305
ANIMAL NUMBER
APPENDIX 4
Individual Clinical Chemistry Data
Females
Day 217
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS
AST/SGOT ALT/SGPT ALK PHOS
IU/L
IU/L
IU/L
GGT IU/L
SDH IU/L
CK IU/L
AMYLASE LIPASE
IU/L
IU/L
Covance 6329-223 3M Study No. T-6295.7
P AMYL U/L
Group: i
105529 105549
MEAIJ S.D. N
Group: 3
105539 105552
MEAN S.D. N
Group: 4
105533 105542
MEAN S.D. N
Dose Level : 0
35 120 34 86
34 .7
2
103 24.0 2
Dose Level: 0.15
19 43 33 54
26 9.9 2
48 7.8 2
Dose Level: 0.75
23 38 23 61
23 .0
2
50 16.3
2
Dosage Unit: mg/kg/day
161 81 208 41
4 5
184 33.2 2
61 28.3
2
4 .7
2
Dosage Unit: mg/kg/day
113 69 251 72
1 7
182 97.6 2
70 2.1 2
4 4.2 2
Dosage Unit: mg/kg/day
241 121 200 68
2 5
220 29.0 2
94 37.5
2
4
2.1 2
157 117
137 28.3 2
117 1197
657 763.7
2
144 186
165 29.7 2
377 309
343 48.1 2
313 658
486 244.0
2
394 296
345 69.3 2
26 0
13 18.4
2
257 232
244 17.7 2
48 17
32 21.9
2
235 466
350 163.3
2
35 41
38 4.2 2
289 222
256 * 47.4
2
003306
ocroo
APPENDIX 4
Individual Clinical Chemistry Data
Females
Day 217
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS
ANIMAL NUMBER
CA MG/DL
I PHOS MG/DL
HA MMOL/L
K MMOL/L
CL MMOL/L
Group : 1
105529 I5549
MEAN S.D. U
Group : 3
105539 I5552
MEAN S.D. N
Group: 4
105533 105542
MEAN S.D. N
Dose Level : 0
9.7 5.9 9.9 3.7
9.8 .14 2
4.8 1.56
2
Dose Level: 0.15
9.9 5.7 9.7 5.3
9.8 .14 2
5.5 .28 2
Dose Level: 0.75
10.4 10.2
5.4 6.3
10.3 .14 2
5.8 .64 2
Dosage Unit: mg/kg/day
145 5.0 103 152 5.9 112
148 4.9 2
5.4 .64 2
108 6.4 2
Dosage Unit: mg/kg/day
155 5.5 112 150 5.5 109
152 3.5 2
5.5 .00 2
110 2.1 2
Dosage Unit: mg/kg/day
152 5.2 111 152 4.9 108
152 .0
2
5.0 .21 2
110 2.1 2
Covance 6329-223 3M Study No. T-6295.7
ANIMAL NUMBER
GLU MG/DL
APPENDIX 4
Individual Clinical Chemistry Data
Males
Day 245
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS
UN MG/DL
CREAT MG/DL
T PRO G/DL
ALB G/DL
GLOB G/DL
T BILI MG/DL
SBA UMOL/L
CHOL MG/DL
Covance 6329-223 3M Study No. T-6295.7
TRIG MG/DL
HDL MG/DL
Group: 1 Dose Level : 0
Dosage Unit: mg/kg/day
105520 105526
116 15 1.2 8.8 4.9 3.9 86 17 1.0 8.6 4.8 3.8
.5 .4
8 114 28 73 9 155 38 81
MEAN S.D. N
101 21.2 2
16 1.4 2
1.1 .14 2
8.7 .14 2
4.8 .07 2
3.8 .07 2
.4 .07
2
8 134 .7 29.0
22
33 7.1 2
77 5.7
2
Group: 3
105505 105523
Dose Level : 0.15
79 17 83 17
Dosage Unit: mg/kg/day
1.2 9.1 5.3 1.0 8.9 5.2
3.8 3.7
.8 5 193 .4 11 128
44 103 52 65
MEAN S.D. N
81 2.8
2
17 .0
2
1.1 .14 2
9.0 .14 2
5.2 .07 2
3.8 .07 2
.6 .28 2
8 160 4.2 46.0 22
48 5.7
2
84 26.9
2
Group: 4 Dose Level : 0.75
Dosage Unit: mg/kg/day
105511 105522
61 16 1.0 8.6 4.4 4.2
.4
7 132 56 54
84 18 1.0 9.1 4.9 4.2
.4 15 139 71
51
MEAN
S.D. N
72 17 1.0 8.8 4.6 4.2
.4 11 136 64 52
16.3 1.4 .00 .35 .35 .00 .00
5.7 4.9 10.6 2.1
22222222222
003308
ANIMAL NUMBER
APPENDIX 4
Individual clinical Chemistry Data
Males
Day 245
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS
AST/SGOT ALT/SGPT ALK PHOS
IU/L
IU/L
IU/L
GGT IU/L
SDH IU/L
CK IU/L
AMYLASE LIPASE
IU/L
IU/L
Covance 6329-223 3H Study No. T-6295.7
P AMYL U/L
Group: l
105520 105526
MEAN S.D. N
Group: 3
105505 105523
MEAN S.D. N
Group: 4
105511 105522
MEAN S.D. N
Dose Level : 0
24 27 30 28
27
4.2 2
28 .7
2
Dose Level: 0.15
49 40 19 40
34 21.2
2
40
.0 2
Dose Level: 0.75
42 33 49 73
46 4.9 2
53 28.3
2
Dosage Unit: mg/kg/day
664 1137
68 220
2 6
900 334.5
2
144 107.5
2
4 2.8 2
Dosage Unit: mg/kg/day
882 186 793 98
6 1
838 62.9 2
142 62.2 2
4 3.5 2
Dosage Unit: mg/kg/day
736 156 625 176
1 6
680 78.5 2
166 14.1 2
4 3.5 2
145 209
177 45.3 2
189 124
156 46.0 2
178 336
257 111.7
2
409 307
358 72.1 2
422 503
462 57.3 2
628 460
544 118.8
2
33 52
42 13.4
2
306 234
270 50 2
22 52
37 21.2
2
241 353
297 79 2
17 48
32 21.9
2
410 333
372 54 2
003309
OTceoo
APPENDIX 4
Individual Clinical Chemistry Data
Males
Day 245
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS
ANIMAL NUMBER
CA MG/DL
I PHOS MG/DL
NA MMOL/L
K MMOL/L
CL MMOL/L
Group : i
105520 105526
MEAN S.D. N
Group: 3
105505 105523
MEAN S.D. N
Group : 4
105511 105522
MEAN S.D. N
Dose Level : 0
9.9 10.4
6.2 7.1
10.2
.35 2
6.6 .64 2
Dose Level : 0.15
11.3 10.5
6.5 6.8
10.9 .57 2
6.6 .21 2
Dose Level : 0.75
10.4 11.3
6.2 7.8
10.8 .64 2
7.0 1.13
2
Dosage Unit: mg/kg/day
152 5.0 117 157 5.0 117
154 3.5 2
5.0 .00 2
117 .0
2
Dosage Unit: mg/kg/day
160 5.2 118 159 5.1 116
160 .7
2
5.2 .07 2
117 1.4 2
Dosage Unit: mg/kg/day
159 5.0 118 164 5.4 114
162 3.5 2
5.2 .28 2
116 2.8 2
Covance 6329-223 3M Study No. T-6295.7
ANIMAL NUMBER
GLU MG/DL
APPENDIX 4
Individual clinical Chemistry Data
Females
Day 245
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS
UN MG/DL
CREAT MG/DL
T PRO G/DL
ALB G/DL
GLOB G/DL
T BILI MG/DL
SBA UMOL/L
CHOL MG/DL
Covance 6329-223 3M Study No. T-6295.7
TRIG MG/DL
HDL MG/DL
Group : 1 Dose Level : 0
Dosage unit: mg/kg/day
105529 105549
48 20 .7 8.5 4.5 4.0 .8
8 94 61 52
68 15 1.2 9.4 4.7 4.7 .3 10 168 53 88
MEAN S.D. N
58 14.1
2
18 3.5 2
1.0 .35 2
9.0 .64 2
4.6 .14 2
4.4 .49 2
.6 .35 2
9 131 1.4 52.3 22
57 5.7 2
70 25.5
2
Group : 3 Dose Level : 0.15
Dosage Unit: mg/kg/day
105539 105552
83 19 i.i 8.8 4.0 4.8 .5 12 163 72 91 91 21 .9 9.2 4.2 5.0 .3 10 138 70 52
MEAN S.D. N
87 20 1.0 9.0 4.1 4.9
.4 11 150 71
72
5.7 1.4 .14 .28 .14 .14 .14
1.4 17.7
1.4 27.6
22222222222
Group : 4 Dose Level : 0.75
Dosage Unit: mg/kg/day
105533 105542
92 22 1.3 9.8 5.0 4.8 .2 19 151 61 54 91 22 1.2 9.0 4.4 4.6 .3 11 147 129 73
MEAN S.D. N
92 22 1.2 9.4 4.7 4.7
.2 15 149
95 64
.7 .0 .07 .57 .42 .14 .07 5.7 2.8 48.1 13.4
22222222222
TTC-00
ANIMAL NUMBER
APPENDIX 4
Individual Clinical Chemistry Data
Females
Day 245
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS
AST/SGOT ALT/SGPT ALK PHOS
IU/L
IU/L
IU/L
GGT IU/L
SDH IU/L
CK IU/L
AMYLASE LIPASE
IU/L
IU/L
Covance 6329-223 3M Study No. T-6295.7
P AMYL U/L
Group : 1
105529 105549
MEAN S.D. M
Group : 3
105539 105552
MEAN S.D. N
Group : 4
105533 105542
MEAN S.D. N
Dose Level : 0
42 158 29 74
36 9.2 2
116 59.4 2
Dose Level : 0.15
24 61 37 71
30 9.2 2
66 7.1 2
Dose Level : 0.75
28 41 22 39
25 4.2 2
40 1.4 2
Dosage Unit: mg/kg/day
160 73 203 44
2 3
182 30.4 2
58 20.5
2
2 .7
2
Dosage Unit: mg/kg/day
113 77 262 83
1 5
188 105.4
2
80 4.2 2
3 2.8 2
Dosage Unit: mg/kg/day
249 121 224 74
2 1
236 17.7 2
98 33.2
2
2 .7
2
204 132
168 50.9 2
120 663
392 384.0
2
168 129
148 27.6 2
363 295
329 48.1 2
311 654
482 242.5
2
385 277
331 76.4 2
21 0
10 14.8
2
46 21
34 17.7
2
113 19
66 66.5
2
261 222
242 27.6 2
235 458
346 157.7
2
289 212
250 54.4 2
Cw M
CTCCOO
APPENDIX 4
Individual Clinical Chemistry Data
Females
Day 245
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS
ANIMAL HUMBER
CA MG/DL
I PHOS MG/DL
NA MMOL/L
K MMOL/L
CL MMOL/L
Group : 1
105529 105549
MEAN S.D. N
Group: 3
105539 105552
MEAN S.D. N
Group : 4
105533 105542
MEAN S.D. N
Dose Level: 0
9.6 4.8 9.8 4.4
9.7 .14 2
4.6 .28 2
Dose Level: 0.15
9.5 10.2
5.6 5.2
9.8 .49 2
5.4 .28 2
Dose Level: 0.75
10.2 11.0
4.9 5.9
10.6 .57 2
5.4 .71 2
Dosage Unit: mg/kg/day
147 4.5 111 153 4.8 118
150 4.2 2
4.6 .21 2
114 4 2
Dosage Unit: mg/kg/day
148 4.9 117 155 5.9 120
152 4.9 2
5.4 .71 2
118 2 2
Dosage Unit: mg/kg/day
155 4.8 116 166 6.2 125
160 7.8
2
5.5 .99 2
120 6 2
Covance 6329-223 3M Study No. T-6295.7
ANIMAL NUMBER
GLU MG/DL
APPENDIX 4
Individual Clinical Chemistry Data
Males
Day 274
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS
UN MG/DL
CREAT MG/DL
T PRO G/DL
ALB G/DL
GLOB G/DL
T BILI MG/DL
SBA UMOL/L
CHOL MG/DL
Covance G329-223 3M Study No. T-6295.7
TRIG MG/DL
HDL MG/DL
Group: 1
105520 105526
MEAN S.D. N
Dose Level : 0
80 13 54 18
67 18.4
2
16 3.5 2
Dosage Unit : mg/kg/day
1.3 8.8 4.8 1.1 8.2 4.6
1.2 .14 2
8.5 .42 2
4.7 .14 2
4.0 3.6
3.8 .28 2
.7 .1
.4 .42 2
3 112 2 149
2 130 .7 26.2
22
25 47
36 15.6
2
54 75
64 14.8
2
Group : 3 Dose Level : 0.15
Dosage Unit: mg/kg/day
105505 105523
76 18 .9 9.0 5.2 3.8 .5 11 203 38 94
72 20 1.1 8.7 4.9 3.8 .3
7 132 57 57
MEAN S.D. N
74 2.8
2
19 1.4 2
1.0 .14 2
8.8 .21 2
5.0 .21 2
3.8 .00 2
.4 .14 2
9 168 2.8 50.2 22
48 13.4
2
76 26.2
2
Group: 4
105511 105522
Dose Level : 0.75
63 20 76 IS
Dosage Unit: mg/kg/day
1.0 8.8 4.5 1.3 8.9 5.1
4.3 3.8
.4 5 135 58 45 .2 10 143 91 35
MEAN S.D. N
70 9.2 2
18 3.5 2
1.2 .21 2
8.8 .07 2
4.8 .42 2
4.0 .35 2
.3 .14 2
8 139 3.5 5.7 22
74
23.3 2
40
7.1 2
003314
ANIMAL NUMBER
APPENDIX 4
individual Clinical Chemistry Data
Males
Day 274
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS
AST/SGOT ALT/SGPT ALK PHOS
IU/L
IU/L
IU/L
GGT IU/L
SDH IU/L
CK IU/L
AMYLASE LIPASE
IU/L
IU/L
Covance 6329-223 3M Study No. T-6295.7
P AMYL U/L
Group: i
IU5520 105526
MEAN S.D. N
Group : 3
105505 105523
MEAN S.D. N
Group: 4
105511 105522
MEAN S.D. N
Dose Level : 0
19 31 37 39
28 12.7
2
35 5.7 2
Dose Level :: 0.15
31 42 22 36
26 6.4 2
39 4.2 2
Dose Level: 0.75
41 39 36 69
38
3.5 2
54 21.2
2
Dosage Unit: mg/kg/day
552 1131
60 188
4 10
842 409.4
124 90.5 2
7 4.2 2
Dosage Unit: mg/kg/day
925 195 776 96
2 6
850
105.4 2
146 70.0 2
4 2.8 2
Dosage Unit: mg/kg/day
821 158 557 169
3 4
689
186.7 2
164 7.8 2
4 .7
2
151 201
176 35.4 2
157 125
141 22.6 2
167 294
230 89.8 2
368 267
318 71.4 2
414 475
444 43.1 2
572 453
512 84.1 2
31 41
36 7.1 2
277 201
239 53 2
41 37
39 2.8 2
232 338
285 75 2
18 52
35 24.0
2
377 331
354 32 2
STDDOO
S *OO
APPENDIX 4
Individual Clinical Chemistry Data
Males
Day 274
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS
ANIMAL NUMBER
CA MG/DL
I PHOS MG/DL
NA MMOL/L
K MMOL/L
CL MMOL/L
Group: 1
105520 105526
MEAN S.D. U
Group: 3
105505 105523
MEAN S.D. N
Group : 4
105511 105522
MEAN S.D. N
Dose Level : 0
10.3 10.0
5.2 6.8
10.2 .21 2
6.0 1.13
2
Dose Level: 0 ..15
12.0 10.3
6.2 6.5
11.2 1.20
2
6.4 .21 2
Dose Level: 0 ..75
10.8 11.6
5.7 7.0
11.2 .57
2
6.4 .92 2
Dosage Unit: mg/kg/day
157 5.9 116 150 5.6 115
154 4.9 2
5.8 .21 2
116 .7
2
Dosage Unit: mg/kg/day
164 5.9 123 154 5.4 114
159 7.1 2
5.6 .35 2
118 6 2
Dosage Unit: mg/kg/day
158 5.4 115 163 5.9 112
160 3.5 2
5.6 .35 2
114 2 2
Covance 6329-223 3M Study No. T-6295.7
ANIMAL NUMBER
GLU MG/DL
APPENDIX 4
Individual Clinical Chemistry Data
Females
Day 274
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS
UN 1MG/DL
CREAT MG/DL
T PRO G/DL
ALB G/DL
GLOB G/DL
T BILI MG/DL
SBA UMOL/L
CHOL MG/DL
Covance 6329-223 3M Study No. T-6295.7
TRIG MG/DL
HDL MG/DL
Group : 1
105529 105549
MEAN S.D. N
Group: 3
105539 105552
MEAN S.D. N
Group : 4
105533 105542
MEAN S.D. N
Dose Level : 0
45 23 67 16
56 15.6
2
20 4.9 2
Dose Level : 0.15
78 19 71 23
74 4.9 2
21 2.8 2
Dose Level : 0.75
95 20 90 26
92 3.5
2
23 4.2 2
Dosage Unit: mg/kg/day
.8 8.1 4.2 .8 9.3 4.6
.8 8.7 4.4 .00 .85 .28 222
Dosage Unit: mg/kg/day
.8 8.7 4.0 1.0 9.1 4.0
.9 8.9 4.0 .14 .28 .00 222
Dosage Unit: mg/kg/day
.9 9.2 4.7 1.1 8.7 4.1
1.0 .14 2
9.0 .35
2
4.4 .42 2
3.9 4.7
4.3 .57 2
4.7 5.1
4.9 .28 2
4.5 4.6
4.6 .07 2
1.0 .2
.6 .57 2
.5 .2
.4 .21 2
.1 .1
.1 .00 2
7 10
8 2.1 2
88 170
129 58.0 2
5 148 5 139
5 144 .0 6.4
22
4 145 7 144
6 144 2.1 .7 22
42 53
48 7.8 2
67 51
59 11.3
2
47 92
70 31.8
2
43 80
62 26.2
2
68 36
52 22.6
2
53 59
56 4.2 2
ANIMAL NUMBER
APPENDIX 4
Individual Clinical Chemistry Data
Females
Day 274
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS
AST/SGOT ALT/SGPT ALK PHOS
IU/L
IU/L
IU/L
GGT IU/L
SDH IU/L
CK IU/L
AMYLASE LIPASE
IU/L
IU/L
Covance 6329-223 3M study NO. T-6295.7
P AMYL U/L
Group: 1
105529 105549
MEAN S.D. II
Group: 3
105539 105552
MEAN S.D. N
Group: 4
105533 105542
MEAN S.D. N
Dose Level :: U
47 128 33 79
40 9.9 2
104 34.6 2
Dose Level : 0,.15
27 60 47 57
37 14.1
2
58 2.1 2
Dose Level : 0..75
42 51 16 36
29 18.4
2
44 10.6
2
Dosage Unit: mg/kg/day
138 70 1fift 45
2 4
163 35.4
2
58 17.7
2
3 1.4 2
Dosere Unit: mg/kg/day
105 77
4
238 76 14
172 94.0 2
76 .7
2
9 7.1 2
Dosage Unit: mg/kg/day
244 108 208 66
6 4
226 25.5 2
87 29.7
2
5 1.4
2
167 435
301 189.5
2
113 2316
1214 1557.8
2
165 120
142 31.8 2
328 290
309 26.9 2
287 649
468 256.0
2
396 235
316 113.8
2
18 0
9 12.7
2
232 218
225 9.9 2
50 98
74 33.9
2
214 465
340 177.5
2
34 31
32 2.1 2
295 177
23 6 83.4 2
stceo o
GTCCOO
APPENDIX 4
Individual Clinical Chemistry Data
Females
Day 274
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTAME SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS
ANIMAL NUMBER
CA MG/DL
I PHOS MG/DL
NA MMOL/L
K MMOL/L
CL MMOL/L
Group: 1
105529 105549
MEAN S. D. N
Group: 3
105539 105552
MEAN S.D. N
Group: 4
105533 105542
MEAN S.D. N
Dose Level: 0
9.3 10.4
4.6 4.2
9.8 .78 2
4.4 .28 2
Dose Level: 0.15
9.5 5.3 9.5 5.2
9.5 .00 2
5.2 .07 2
Dose Level: 0.75
10.4 10.4
5.8 4.6
10.4 .00 2
5.2 .85
2
Dosage Unit: mg/kg/day
144 4.3 107 155 5.6 114
150 7.8
2
5.0 .92 2
110 4.9
2
Dosage Unit.- mg/kg/day
152 5.4 115 148 4.1 107
150 2.8 2
4.8
.92 2
111 5.7 2
Dosage Unit: mg/kg/day
154 6.1 121 157 6.0 117
156 2.1 2
6.0 .07 2
119 2.8
2
Covance 6329-223 3M Study No. T-6295.7
ANIMAL NUMBER
GLU MG/DL
APPENDIX 4
Individual Clinical Chemistry Data
Males
Day 322
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS
UN 1MG/DL
CREAT MG/DL
T PRO G/DL
ALB G/DL
GLOB G/DL
T BILI MG/DL
SBA UMOL/L
CHOL MG/DL
Covance 6329-223 3M Study No. T-6295.7
TRIG MG/DL
HDL MG/DL
Group : 1
105520 105526
MEAN S.D. N
Group: 3
105505 105523
MEAN S.D. N
Group: 4
105511 105522
MEAN S.D. N
Dose Level : 0
74 19 68 16
71 4.2 2
18 2.1 2
Dose Level : 0.15
45 26 78 30
62 23.3
2
28 2.8 2
Dose Level : 0.75
55 18 76 19
66 14.8
2
18 .7
2
Dosage Unit: mg/kg/day
1.3 8.5 4.7 1.2 8.6 4.9
1.2 .07 2
8.6 .07 2
4.8 .14 2
Dosage Unit: mg/kg/day
1.3 9.0 5.2 1.6 8.4 5.0
1.4 .21 2
8.7
.42 2
5.1 .14 2
Dosage Unit: mg/kg/day
1.2 8.2 4.4 1.7 8.9 5.0
1.4 .35 2
8.6 .49 2
4.7 .42 2
3.8 3.7
3.8 .07 2
3.8 3.4
3.6 .28 2
3.8 3.9
3.8 .07 2
.8 .0
.4 .57 2
1.2 .2
.7 .71 2
.6 .2
.4 .28 2
5 109 6 158
6 134 .7 34.6
22
67 36
52 21.9
2
8 209 6 117
7 163 1.4 65.1 22
48 74
61 18.4
2
6 137
54
9 136 127
8 136 2.1 .7 22
90 51.6
2
57 81
69 17.0
2
91 54
72 26.2
2
44 34
39 7.1 2
ozceoo
ANIMAL NUMBER
APPENDIX 4
Individual Clinical Chemistry Data
Males
Day 322
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS
AST/SGOT ALT/SGPT ALK PHOS
IU/L
IU/L
IU/L
GGT IU/L
SDH IU/L
CK IU/L
AMYLASE LIPASE
IU/L
IU/L
Covance 6329-223 3M Study No. T-6295.7
P AMYL U/L
Group: 1
105520 105526
MEAN S.D. N
Group: 3
105505 105523
MEAN S.D. N
Group: 4
105511 105522
MEAN
S.D.
N
Dose Level:. 0
34 34 42 43
38 5.7
2
38 6.4
2
Dose Level :: 0.15
60 63 46 73
53 9.9
2
68 7.1 2
Dose Level : 0.75
76 59 46 92
61 21.2
2
76 23.3
2
Dosage Unit: mg/kg/day
499 1046
50 199
3 5
772 386.8
2
124 105.4
2
4 1.4 2
Dosage Unit: mg/kg/day
995 189 770 92
6 6
882 159.1
2
140 68.6 2
6 .0
2
Dosage Unit: mg/kg/day
844 156 573 158
3 1
708 191.6
2
157 1.4 2
2 1.4 2
860 1071
966 149.2
2
515 624
570 77.1 2
787 1308
1048 368.4 2
512 462
487 35.4 2
1618 976
1297 454.0 2
727 523
625 144.2
2
90 98
94 5.7 2
380 352
366 19.8 2
871 549
710 227.7
2
1193 731
962 326.7
2
36 25
30 7.8 2
503 382
442 85.6 2
003321
003322
APPENDIX 4
Individual clinical Chemistry Data
Males
Day 322
26-WEEK c a p s u l e t o x i c i t y s t u d y w i t h p e r f l u o r o o c t a n e s u l f o n i c a c i d POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS
ANIMAL NUMBER
CA MG/DL
I PHOS MG/DL
NA MMOL/L
K MMOL/L
CL MMOL/L
Group : 1
I05S20 105526
MEAN S.D. N
Group : 3
105505 105523
MEAN S.D. N
Group : 4
105511 105522
MEAN S.D. N
Dose Level : 0
10.1 10.8
5.0 5.8
10.4 .49 2
5.4 .57 2
Dose Level : 0.15
11.6 10.3
6.3 5.4
11.0 .92 2
5.8 .64 2
Dose Level : 0.75
9.9 11.2
5.0 6.6
10.6 .92 2
5.8 1.13
2
Dosage Unit: mg/kg/day
148 4.9 107 153 5.1 106
150 3.5
2
5.0 .14 2
106 2
Dosage Unit: mg/kg/day
154 5.1 104 154 5.0 108
154 .0
2
5.0
.07 2
106 2 2
Dosage Unit: mg/kg/day
151 5.1 108 158 5.6 108
154 4.9 2
5.4 .35 2
108 2
Covance S329-223 3M Study No. T-6295.7
ANIMAL NUMBER
GLU MG/DL
APPENDIX 4
Individual Clinical Chemistry Data
Females
Day 322
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS
UN MG/DL
CREAT MG/DL
T PRO G/DL
ALB G/DL
GLOB G/DL
T BILI MG/DL
SBA UMOL/L
CHOL MG/DL
Covance 6329-223 3M Study No. T-6295.7
TRIG MG/DL
HDL MG/DL
Group: 1 Dose Level : 0
Dosage Unit: mg/kg/day
105529 105549
MEAN S.D. N
44 16 1.4 8.4 4.4 4.0 .9
6 89 48 41
64 14 1.1 8.5 4.3 4.2 .1 13 148 36 74
54 15 1.2 8.4 4.4 4.1 .5 10 118 42 58
14.1 1.4 .21 .07 .07 .14 .57 222 222
4.9 41.7 22
8.5 23.3 -> 2
Group: 3 Dose Level : 0.15
Dosage Unit: mg/ kg/day
105539 105552
69 27 1.4 8.2 3.8 4.4
.5 11 141 102
74
58 28 1.2 9.3 4.0 5.3
.5
6 154 69 46
MEAN S.D. N
64 7.8 2
28 .7
2
1.3 .14 2
8.8 .78 2
3.9 .14 2
4.8 .64 2
.5 .00 2
8 148 3.5 9.2 22
86 23.3
2
60 19.8
2
Group : 4 Dose Level : 0.75
Dosage Unit: mg/kg/day
105533 105542
86 25 1.6 9.1 4.6 4.5 .1 84 12 1.4 8.2 4.0 4.2 .0
8 139 68 60 5 119 81 60
MEAN S.D. N
85 1.4 2
18 9.2 2
1.5 .14 2
8.7 .64 2
4.3 .42 2
4.4 .21 2
.0 .07 2
6 129 2.1 14.1 22
74 9.2 2
60 .0
2
003323
ANIMAL NUMBER
APPENDIX 4
Individual Clinical Chemistry Data
Females
Day 322
26-WEEK CAPSULE TOXICITY STUDY WITH PEFFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS
AST/SGOT ALT/SGPT ,RLK PHOS
IU/L
IU/L
IU/L
GGT IU/L
SDH IU/L
CK IU/L
AMYLASE LIPASE
IU/L
IU/L
Covance 6329-223 3M Study No, T-6295.7
P AMYL U/L
Group : 1
105529 105549
MEAN S.D. N
Group: 3
105539 105552
MEAN S.D. N
Group: 4
105533 105542
MEAN S.D. N
Dose Level:; 0
66 97 46 77
56 14.1
2
87 14.1
2
Dose Level : 0..15
36 71 60 85
48 17.0
2
78 9.9 2
Dose Level:; 0..75
43 70 46 155
44 2.1 2
112 60.1
2
Dosage Unit: mg/kg/day
143 82 169 39
2 5
156 18.4 2
60 30.4
2
4 2.1 2
Dosage Unit: mg/kg/day
114 67 205 79
4 9
160 64.3 2
73 8.5
2
6 3.5 2
Dosage Unit: mg/kg/day
250 105 220 55
2 I
235 21.2 2
80 35.4
2
2 .7
2
1212 1024
1118 132.9 2
602 1513
1058 644.2 2
1471 659
1065 574.2 2
390 342
366 33.9 2
386 722
554 237.6
2
448 450
449 1.4 2
0 277 0 260
0 268 .0 12.0
22
63 83
73 14.1
2
288 524
406 166.9
2
33 94
64 43.1
2
337 339
338 1.4 2
003324
003325
APPENDIX 4
Individual clinical Chemistry Data
Females
Day 322
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS
ANIMAL NUMBER
CA MG/DL
I PHOS MG/DL
NA MMOL/L
K MMOL/L
CL MMOL/L
Group : 1
I5529 105549
MEAN S.D . 11
Group: 3
105539 105552
MEAN S.D. N
Group : 4
105533 105542
MEAN S.D. N
Dose Level : 0
9.8 5.0 9.6 4.4
9.7 .14 2
4.7 .42 2
Dose Level : 0.15
9.4 10.2
4.8 5.5
9.8 .57 2
5.2 .49 2
Dose Level : 0.75
10.3 10.3
4.4 4.1
10.3 .00 2
4.2 .21 2
Dosage Unit: mg/kg/day
146 5.1 100 148 4.8 107
147 1.4 2
5.0 .21 2
104 4 2
Dosage Unit: mg/kg/day
148 5.2 107 154 5.1 109
151 4.2 2
5.2 .07 2
108 1 2
Dosage Unit: mg/kg/day
154 5.2 109 158 5.8 111
156 2.8 2
5.5
.42 2
110 1 2
Covance G329-223 3M Study No. T-6295.7
ANIMAL NUMBER
GLU MG/DL
APPENDIX 4
Individual Clinical Chemistry Data
Males
Day 364
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS
UN MG/DL
CREAT MG/DL
T PRO G/DL
ALB G/DL
GLOB G/DL
T BILI MG/DL
SBA UMOL/L
CHOL MG/DL
Covance 6329-223 3M Study No. T-6295.7
TRIG MG/DL
HDL MG/DL
Group : 1
105520 105526
MEAN S.D. n
Group : 3
105505 105523
MEAN S.D. N
Group: 4
105511 105522
MEAN S.D. N
Dose Level : 0
74 17 71 24
72 2.1 2
20 4.9 2
Dose Level : 0.15
73 23 76 28
74 2.1 2
26 3.5
2
Dose Level : 0.75
63 19 76 17
70 9.2 2
18 1.4 2
Dosage Unit: mg/kg/day
1.3 8.9 5.0 1.3 8.9 5.3
1.3 .00 2
8.9 .00 2
5.2 .21 2
Dosage Unit: mg/kg/day
1.2 9.0 5.4 1.1 8.1 4.9
1.2 .07 2
8.6 .64 2
5.2 .35 2
Dosage Unit: mg/kg/day
l.i 8.3 4.5 1.3 8.5 5.0
1.2 .14 2
8.4 .14 2
4.8 .35 2
3.9 3.6
3.8 .21 2
3.6 3.2
3.4 .28 2
3.8 3.5
3.6 .21 2
.7 .3
.5 .28 2
1.1 .5
.8 .42 2
.6 .3
.4 .21 2
5 105 6 148
6 126 .7 30.4
22
7 206 6 127
6 166 .7 55.9
22
6 116 3 122
4 119 2.1 4.2 22
35 46
40 7.8 2
33 64
48 21.9
2
36 66
51 21.2
2
51 71
61 14.1
2
93 54
74 27.6
2
41 34
38 4.9 2
9ZCCOO
ANIMAL NUMBER
APPENDIX 4
Individual clinical Chemistry Data
Males
Day 364
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS
AST/SGOT ALT/SGPT ALK PHOS
IU/L
IU/L
IU/L
GGT IU/L
SDH IU/L
CK IU/L
AMYLASE LIPASE
IU/L
IU/L
Covance 6329-223 3M Study No. T-6295.7
P AMYL U/L
Group : 1
105520 105526
MEAN S.D. H
Group : 3
105505 105523
MEAN S.D. N
Group : 4
105511 105522
MEAN S.D. N
Dose Level: 0
46 45 53 38
50 4.9 2
42 4.9
2
Dose Level: 0.15
64 63 55 70
60 6.4 2
66 4.9 2
Dose Level: 0.75
62 48 58 84
60 2.8
2
66 25.5
2
Dosage Unit: mg/kg/day
387 1040
53 222
3 8
714 461.7
2
138 119.5
2
6 3.5 2
Dosage Unit: mg/kg/day
915 188 725 98
9 8
820 134.4
2
143 63.6 2
8 .7
2
Dosage Unit: mg/kg/day
765 154 479 156
6 2
622 202.2
2
155 1.4 2
4 2.8 2
2123 2151
2137 19.8 2
1243 1747
1495 356.4 2
617 2004
1310 980.8 2
388 363
376 17.7 2
1640 948
1294 489.3 2
616 415
516 142.1
2
38 37
38 .7
2
298 246
272 36.8 2
793 365
579 302.6
2
1207 710
958 351.4
2
35 31
33 2.8 2
414 302
358 79.2 2
003327
8ZCC00
APPENDIX 4
Individual Clinical Chemistry Data
Males
Day 364
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS
ANIMAL NUMBER
CA MG/DL
I PHOS MG/DL
NA MMOL/L
K MMOL/L
CL MMOL/L
Group: 1
I0S520 105526
MEAN S.D. N
Group : 3
105505 105523
MEAN S.D. N
Group: 4
105511 105522
MEAN S.D. N
Dose Level : 0
10.3 11.0
4.2 5.2
10.6 .49 2
4.7 .71 2
Dose Level : 0.15
11.9 9.9
5.7 5.5
10.9 1.41 2
5.6 .14 2
Dose Level : 0.75
10.2 10.9
5.2 4.6
10.6 .49 2
4.9 .42 2
Dosage Unit: mg/kg/day
154 5.3 111 157 5.5 111
156 2.1 2
5.4
.14 2
111 .0
2
Dosage Unit: mg/kg/day
160 5.8 113 150 5.1 109
155 7.1 2
5.4 .49 2
111 2.8
2
Dosage Unit: mg/kg/day
153 5.9 113 156 5.0 108
154 2.1 2
5.4 .64 2
110 3.5 2
Covance 6329-223 3M Study No. T-6295.7
ANIMAL NUMBER
GLU MG/DL
APPENDIX 4
Individual Clinical Chemistry Data
Females
Day 364
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS
UN 1MG/DL
CREAT MG/DL
T PRO G/DL
ALB G/DL
GLOB G/DL
T BILI MG/DL
SBA UMOL/L
CHOL MG/DL
Covance 6329-223 3M Study No. T-6295.7
TRIG MG/DL
HDL MG/DL
Group : 1
105529 105549
MEAN S.D. N
Group : 3
105539 105552
MEAN S.D. N
Group : 4
105533 105542
MEAN S.D. N
Dose Level : 0
54 21 56 18
55
1.4 2
20 2.1 2
Dose Level : 0.15
66 22 80 26
73 9.9 2
24 2.8
2
Dose Level : 0.75
91 21 85 25
88 4.2 2
23 2.8 2
Dosage Unit: mg/kg/day
.9 8.9 4.7 1.1 9.0 4.7
1.0 .14 2
9.0 .07 2
4.7 .00 2
Dosage Unit: mg/kg/day
1.1 8.3 3.8 1.0 9.1 4.0
X. .07
2
8.7 .57 2
3.9 .14 2
Dosage Unit: mg/kg/day
1.2 9.2 4.9 1.1 8.1 4.0
1.2 .07
2
8.7 .78 2
4.4 .64 2
4.2 4.3
4.2 .07 2
4.5 5.1
4.8 .42 2
4.3 4.1
4.2 .14 2
1.1 .4
.8 .49 2
.8 .7
.8 .07 2
.3 .4
.4 .07 2
5 112 6 162
137 .7 35.4
22
6 13 6 6 138
6 137 .0 1.4
22
13 5
9 5.7 2
152 131
142 14.8 2
56 42
49 9.9 2
66 43
54 16.3
2
55 95
75 28.3
2
40 79
60 27.6
2
71 36
54 24.7
2
55 66
60 7.8 2
003329
ANIMAL NUMBER
APPENDIX 4
Individual Clinical Chemistry Data
Females
Day 364
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT PFOS; T-6295) IN CYNOMOLGUS
AST/SGOT ALT/SGPT ALK PHOS
IU/L
IU/L
IU/L
GGT IU/L
SDH IU/L
CK IU/L
AMYLASE LIPASE
IU/L
IU/L
Covance 6329-223 3M Study No. T-6295.7
P AMYL U/L
Group: 1
105529 105549
MEAN S.D. N
Group : 3
105539 105552
MEAN S.D. N
Group: 4
105533 105542
MEAN S.D. N
Dose Level:: 0
110 297 61 106
86 34.6
2
202 135.1
2
Dose Level :: 0..15
37 61 62 95
50 17.7
2
78 24.0
2
Dose Level:: 0..75
67 78 45 83
56 15.6
2
80 3.5 2
Dosage Unit: mg/kg/day
157 109 167 45
7 5
162 7.1 2
77 45.3
2
6 1.4 2
Dosage Unit: mg/kg/day
109 78
8
188 80 15
148 55.9 2
79 1.4 2
12 4.9 2
Dosage Unit: mg/kg/day
243 117 213 56
5 3
228 21.2 2
86 43.1
2
4 1.4 2
2978 1838
2408 806.1 2
733 1009
871 195.2
2
2353 1241
1797 786.3 2
459 338
398 85.6 2
304 630
467 230.5
2
527 431
479 67.9 2
33 0
16 23.3
2
336 265
300 50.2 2
42 52
47 7.1 2
231 459
345 161.2
2
47 47
47 .0
2
412 329
370 58.7 2
003330
00333
APPENDIX 4
Individual Clinical Chemistry Data
Females
Day 364
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS
ANIMAL NUMBER
CA MG/DL
I PHOS MG/DL
NA MMOL/L
K MMOL/L
CL MMOL/L
Group : 1
105529 105549
MEAN S.D. N
Group : 3
105539 105552
MEAN S.D. N
Group : 4
105533 105542
MEAN S.D. N
Dose Level : 0
9.7 10.1
5.6 4.2
9.9 .28 2
4.9 .99 2
Dose Level : 0.15
9.0 4.8 9.9 4.7
9.4 .64 2
4.8 .07 2
Dose Level : 0.75
10.5 10.0
4.6 4.3
10.2 .35 2
4.4 .21 2
Dosage Unit: mg /kg/day
144 4.3 103 151 5.6 109
148 4.9 2
5.0 .92 2
106 4 2
Dosage Unit: mg/kg/day
146 4.9 108 151 5.9 111
148 3.5 2
5.4 .71
2
110 2 2
Dosage Unit: mg/kg/day
153 5.3 111 157 5.6 113
155 2.8 2
5.4 .21 2
112 1 2
Covance 6329-223 3M Study No. T-6295.7
ANIMAL NUMBER
GLU MG/DL
APPENDIX 4
Individual Clinical Chemistry Data
Males
Day 456
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS
UN MG/DL
CREAT MG/DL
T PRO G/DL
ALB G/DL
GLOB G/DL
T BILI MG/DL
SBA UMOL/L
CHOL MG/DL
Covance 6329-223 3M Study No. T-6295.7
TRIG MG/DL
HDL MG/DL
Group : 1
105520 105526
MEAN S.D. N
Group: 3
105505 105523
MEAN S.D. N
Group: 4
105511 105522
MEAN S.D. N
Dose Level : 0
80 12 68 16
74 8.5 2
14 2.8 2
Dose Level : 0.15
88 15 94 17
91 4.2 2
16 1.4 2
Dose Level : 0.75
64 13 75 14
70 7.8 2
14 .7
2
Dosage Unit: mg/kg/day
1.2 8.9 5.2 1.2 8.5 4.9
1.2 .00 2
8.7 .28 2
5.0 .21 2
Dosage Unit: mg/kg/day
1.2 9.3 5.4 1.1 8.9 5.5
1.2 .07
2
9-1 .28 2
5.4 .07 2
Dosage Unit: mg/kg/day
1.0 8.5 4.5 1.3 9.3 5.4
1.2 .21 2
8.9 .57 2
5.0 .64 2
3.7 3.6
3.6 .07 2
3.9 3.4
3.6 .35 2
4.0 3.9
4.0 .07 2
.8 .3
.6 .35 2
.6 .3
.4 .21 2
.8 .3
.6 .35 2
3 122 3 142
3 132 .0 14.1
22
5 216 6 139
6 178 .7 54.4
22
4 122 3 114
4 118 ,7 5.7
22
31 32
32 .7
2
56 61
58 3.5 2
39 43
41 2.8 2
106 55
80 36.1
2
37 81
59 31.1
2
44 26
35 12.7
2
003332
ANIMAL NUMBER
APPENDIX 4
Individual Clinical Chemistry Data
Males
Day 456
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS
AST/SGOT ALT/SGPT ALK PHOS
IU/L
IU/L
IU/L
GGT IU/L
SDH IU/L
CK IU/L
AMYLASE LIPASE
IU/L
IU/L
Covance 6329-223 3M Study No. T-6295.7
P AMYL U/L
Group : 1
105520 105526
MEAN S.D. N
Group: 3
105505 105523
MEAN S.D. N
Group : 4
105511 105522
MEAN S.D. N
Dose Level : 0
19 21 29 26
24 7.1 2
24 3.5 2
Dose Level: 0.15
29 46 21 45
25 5.7 2
46 .7
2
Dose Level : 0.75
37 32 30 50
34 4.9 2
41 12.7
2
Dosage Unit: mg/kg/day
394 59 847 189
2 10
620 320.3
2
124 91.9 2
6 5.7 2
Dosage Unit: mg/kg/day
971 198 771 101
2 1
871 141.4
2
150 68.6 2
2 .7
2
Dosage Unit: mg/kg/day
458 129 379 148
1 0
418 55.9 2
138 13.4 2
0 .7
2
77 126
102 34.6 2
163 119
141 31.1 2
179 225
202 32.5 2
319 276
298 30.4 2
413 487
450 52.3 2
480 364
422 82.0 2
11 21
16 7.1 2
246 220
233 18.4 2
14 17
16 2.1 2
235 353
294 83.4 2
20 13
16 4.9 2
326 263
294 44.5 2
003333
YCCOQ
APPENDIX 4
Individual Clinical Chemistry Data
Males
Day 456
26-WEEK CAPSULE TOXICITY STUDY WITH PEP.FLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS
ANIMAL NUMBER
CA MG/DL
I PHOS MG/DL
HA MMOL/L
K MMOL/L
CL MMOL/L
Group: 1
105520 105526
MEAN S.D. N
Group : 3
105505 105523
MEAN S.D. H
Group : 4
105511 105522
MEAN S.D. N
Dose Level : 0
10.4 10.1
5.7 6.4
10.2 .21 2
6.0 .49 2
Dose Level : 0.15
12.6 10.9
6.6 7.2
11.8 1.20 2
6.9 .42 2
Dose Level : 0.75
10.0 11.1
3.9 6.7
10.6 .78 2
5.3 1.98
2
Dosage Unit: mg/kg/day
156 5.7 113 150 5.1 109
153 4.2 2
5.4 .42 2
111 2 2
Dosage Unit: mg/kg/day
167 6.3 118 161 5.6 113
164 4.2 2
6.0 .49 2
116 3 2
Dosage Unit: mg/kg/day
152 4.6 113 158 5.4 109
155 4.2 2
5.0 .57 2
111 2 2
Covance 6329-223 3M Study No. T-6295.7
ANIMAL NUMBER
GLU MG/DL
APPENDIX 4
Individual Clinical Chemistry Data
Females
Day 456
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; '-6295) IN CYNOMOLGUS
UN MG/DL
CREAT MG/DL
T PRO G/DL
ALB G/DL
GLOB G/DL
T BILI MG/DL
SBA UMOL/L
CHOL MG/DL
Covance 6329-223 3M Study No. T-6295.7
TRIG MG/DL
HDL MG/DL
Group: 1
105529 105549
MEAN S.D. N
Group: 3
105539 105552
MEAN S.D. N
Group: 4
105533 105542
MEAN S.D. N
Dose Level : 0
48 17 79 17
64 21.9
2
17 .0
2
Dose Level: 0.15
79 16 78 18
78 .7
2
17 1.4 2
Dose Level: 0.75
98 17 101 21
100 2.1 2
19 2.8 2
Dosage Unit: mcr/kg/day
.9 8.3
4.6
1.0 8.7 4.6
1.0 .07
2
8.5 .28 2
4.6 .00 2
Dosage Unit: mg/kg/day
1.0 8.4 4.1 .9 9.0 4.1
1.0 .07 2
8.7 .42 2
4.1 .00 2
Dosage Unit: mg/kg/day
1.1 9.1 4.9 1.0 8.2 4.1
1.0 .07 2
8.7 .64 2
4.5 .57 2
3.7 4.1
3.9 .28 2
4.3 4.9
4.6 .42 2
4.2 4.1
4.2 .07 2
1.0 .3
.6 .49 2
.6 .5
.6 .07 2
.2 .3
.2 .07 2
7 99 4 142
6 120 2.1 30.4 22
60 52
56 5.7 2
4 144 6 144
5 144 1.4 .0 22
83 59
71 17.0
2
5 137
42
3 139 114
4 138 1.4 1.4 22
78 50.9
2
34 67
50 23.3
2
58 36
47 15.6
2
55 72
64 12.0
2
003335
ANIMAL NUMBER
APPENDIX 4
Individual Clinical Chemistry Data
Females
Day 456
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS
AST/SGOT ALT/SGPT ALK PHOS
IU/L
IU/L
IU/L
GGT IU/L
SDH IU/L
CK IU/L
AMYLASE LIPASE
IU/L
IU/L
Covance 6329-223 3M Study No. T-6295.7
P AMYL U/L
Group : 1
105529 I5549
MEAN S.D. N
Group: 3
105539 105552
MEAN S.D. N
Group: 4
105533 105542
MEAN S.D. N
Dose Level :: 0
56 183 30 85
43 18.4
2
134 69.3 2
Dose Level :: 0.15
25 34 40 66
32 10.6
2
50 22.6
2
Dose Level: 0.75
25 64 25 43
25 .0
2
54 14.8
2
Dosage Unit: mg/kg/day
139 96 174 49
6 3
156 24.7 2
72 33.2
2
4 2.1 2
Dosage Unit : mg/kg/day
94 76
4
186 81 10
140 65.1 2
78 3.5 2
7 4.2 2
Dosage Unit: mg/kg/day
248 124 216 63
0 3
232 22.6 2
94 43.1
2
2 2.1 2
200 244
222 31.1 2
112 254
183 100.4
2
134 114
124 14.1 2
293 244
268 34.6 2
242 436
339 137.2
2
360 233
296 89.8 2
9 12
10 2.1 2
216 192
204 17.0 2
15 11
13 2.8 2
189 312
250 87.0 2
13 23
18 7.1 2
277 183
230 66.5 2
003336
APPENDIX 4
Individual clinical Chemistry Data
Females
Day 456
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS
ANIMAL NUMBER
CA MG/DL
I PHOS MG/DL
NA MMOL/L
K MMOL/L
CL MMOL/L
Group : 1
105529 105549
MEAN S.D. H
Group : 3
105539 105552
MEAN S.D11
Group: 4
105533 105542
MEAN S.D. N
Dose Level : 0
9.6 10.2
4.9 5.4
9.9 .42 2
5.2 .35 2
Dose Level : 0.15
9.5 10.1
5.3 5.0
9.8 .42 2
5.2 .21 2
Dose Level : 0.75
10.3 10.5
5.1 5.6
10.4 .14 2
5.4 .35 2
Dosage Unit: mg/kg/day
144 4.9 105 152 5.1 110
148 5.7 2
5.0 .14 2
108 3 2
Dosage Unit: mg/kg/day
151 5.4 ill 153 5.9 112
152 1.4 2
5.6 .35 2
112 2
Dosage Unit: mg/kg/day
155 5.6 114 154 6.8 118
154 .7
2
6.2 .85 2
116 2 2
Covance 6329-223 3M Study No. T-6295.7
eccoo
vi
ANIMAL NUMBER
GLU MG/DL
APPENDIX 4
Individual Clinical Chemistry Data
Males
Day 546
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS
UN 1MG/DL
CREAT MG/DL
T PRO G/DL
ALB G/DL
GLOB G/DL
T BILI MG/DL
SBA UMOL/L
CHOL MG/DL
Covance 6329-223 3M Study No. T-6295.7
TRIG MG/DL
HDL MG/DL
Group : 1
105520 105526
MEAN S.D. N
Dose Level : 0
79 14 86 18
82 4.9
2
16 2.8 2
Dosage Unit: mg/kg/day
1.2 8.7 4.6 1.3 8.9 4.8
1.2 .07 2
8.8 .14 2
4.7 .14 2
4.1 4.1
4.1 .00 2
.5 .2
.4 .21 2
6 119 5 150
6 134 .7 21.9
22
30 32
31 1.4 2
63 77
70 9.9 2
Group: 3
105505 105523
Dose Level : 0.15
77 19 81 19
Dosage Unit: mg/kg/day
1.2 8.6 4.9 1.1 9.0 5.3
3.7 3.7
.6 .3
5 200 3 132
31 114 40 69
MEAN S.D. N
79 2.8 2
19 .0
2
1.2 .07
2
8.8 .28 2
5.1 .28 2
3.7 .00 2
.4 .21
2
4 166 1.4 48.1 22
36 6.4 2
92 31.8
2
Group : 4 Dose Level : 0.75
Dosage Unit: mg/kg/day
105511 105522
75 16 1.4 9.5 5.0 4.5 .8
4 145 37 67
83 16 1.4 9.3 5.2 4.1 .3 10 132 52 47
MEAN S.D. N
79 5.7
2
16 .0
2
1.4 .00 2
9.4 .14 2
5.1 .14 2
4.3 .28 2
.6 .35 2
7 138 4.2 9.2 22
44 10.6
2
57 14.1
2
003338
ANIMAL NUMBER
APPENDIX 4
Individual Clinical Chemistry Data
Males
Day 546
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS
AST/SGOT ALT/SGPT ALK PHOS
IU/L
IU/L
IU/L
GGT IU/L
SDH IU/L
CK IU/L
AMYLASE LIPASE
IU/L
IU/L
Covance 6329-223 3M Study No. T-6295.7
P AMYL U/L
Group : 1
105520 105526
MEAN S.D. N
Group : 3
105505 105523
MEAN S.D. N
Group : 4
105511 105522
MEAN S.D. N
Dose Level : 0
19 20 28 30
24
6.4 2
25 7.1 2
Dose Level : 0.15
31 36 30 33
30 .7
2
34 2.1 2
Dose Level : 0.75
45 37 27 42
36
12.7 2
40 3.5 2
Dosage Unit: mg/kg/day
309 49 701 183
1 19
505
277.2 2
116 94.8 2
10 12.7
2
Dosage Unit: mg/kg/day
846 178 662 93
1 5
754 130.1
2
136 60.1 2
3 2.8 2
Dosage Unit: mg/kg/day
467 149 342 147
0 0
404 88.4 2
148 1.4 2
0
.0 2
78 144
111 46.7 2
130 212
171 58.0 2
165 165
165 .0
2
265 259
262 4.2 2
357 446
402 62.9 2
519 362
440 111.0
2
10 17
14 4.9 2
203 201
202 1 2
12 13
12 .7
2
206 321
264 81 2
22 11
16 7.8 2
334 260
297 52 2
003339
003340
APPENDIX 4
Individual Clinical Chemistry Data
Males
Day 546
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS
ANIMAL
NUMBER
CA
MG/DL
I PHOS MG/DL
NA
1MMOL/L
K MMOL/L
CL MMOL/L
Group : 1
I0S520 105526
MEAN S.D. U
Group : 3
105505 105523
MEAN S.D.
N
Group: 4
105511 105522
MEAN S.D. N
Dose Level : 0
10.8 10.5
6.5 6.6
10.6 .21 2
6.6 .07 2
Dose Level : U .15
11.4 11.0
6.3 7.6
11.2 .28 2
7.0 .92 2
Dose Level : 0.75
12.0 11.8
5.4 6.2
11.9 .14 2
5.8 .57
2
Dosage Unit: mg/kg/day
162 6.4 120 157 5.6 111
160 3.5
2
6.0 .57 2
116 6
2
Dosage Unit: mg/kg/day
164 5.8 117 169 6.9 122
166 3.5 2
6.4 .78 2
120 3 2
Dosage Unit: mg/kg/day
174 6.0 121 169 6.2 116
172 3.5
2
6.1 .14 2
118 3
2
Covance 6329-223 3M Study No. T-6295.7
ANIMAL NUMBER
GLU MG/DL
APPENDIX 4
Individual Clinical Chemistry Data
Females
Day 546
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS
UN MG/DL
CREAT MG/DL
T PRO G/DL
ALB G/DL
GLOB G/DL
T BILI MG/DL
SBA UMOL/L
CHOL MG/DL
Covance 6329-223 3M Study No. T-6295.7
TRIG HG/DL
HDL MG/DL
Group : 1
105529 105549
MEAN S.D. N
Group : 3
105539 105552
MEAN S.D. N
Group : 4
105533 105542
MEAN S.D. N
Dose Level : 0
67 17 53 16
60 9.9 2
16 .7
2
Dose Level : 0.15
71 19 74 17
72 2.1 2
18 1.4 2
Dose Level : 0.75
100 19 93 19
96 4.9
2
19 .0
2
Dosage Unit: mg/kg/day
.9 8.2 4.4 1.0 8.8 4.4
1.0 .07 2
8.5 .42 2
4.4 .00 2
Dosage Unit: mg/kg/day
1.1 8.5 3.9 .8 8.2 3.6
1.0 .21 2
8.4 .21 2
3.8 .21 2
Dosage Unit: mg/kg/day
1.2 9.0 4.6 1.2 7.9 4.0
1.2 .oo 2
8.4 .78 2
4.3 .42 2
3.8 4.4
4.1 .42 2
4.6 4.6
4.6 .00 2
4.4 3.9
4.2 .35 2
.8 .3
.6 .35 2
.5 .6
.6 .07 2
.3 .3
.3 .00 2
6 96 5 152
6 124 .7 39.6
22
55 51
53 2.8 2
5 147 5 129
5 138 .0 12.7
22
73 46
60 19.1
2
6 145
40
4 147 112
5 146 1.4 1.4 22
76 50.9
2
44 83
64 27.6
2
86 37
62 34.6
2
68 79
74 7.8 2
003341
\
ANIMAL NUMBER
APPENDIX 4
Individual Clinical Chemistry Data
Females
Day 546
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS
AST/SGOT ALT/SGPT ALK PHOS
IU/L
IU/L
IU/L
GGT IU/L
SDH IU/L
CK IU/L
AMYLASE LIPASE
IU/L
IU/L
Covance 6329-223 3M Study No. T-6295.7
P AMYL U/L
Group : 1
105529 105549
MEAN S.D. N
Group : 3
105539 105552
MEAN S.D. N
Group: 4
105533 105542
MEAN S.D. N
Dose Level: 0
53 191 30 49
42 16.3
2
120
100.4 2
Dose Level : 0.15
27 31 26 37
26 .7
2
34 4.2 2
Dose Level : 0.75
36 79 19 39
28 12.0
2
59 28.3
2
Dosage Unit: mg/kg/day
131 93 171 45
0 0
151 28.3 2
69 33.9
2
0 .0
2
Dosage Unit: mg/kg/day
96 76 195 82
2 1
146 70.0 2
79 4.2 2
2 .7
2
Dosage unit: mg/kg/day
240 117 186 61
3 0
213 38.2 2
89 39.6
2
2 2.1 2
216 93
154 87.0 2
80 109
94 20.5
2
164 97
130 47.4 2
316 245
280 50.2 2
252 454
353 142.8
2
372 250
311 86.3 2
11 12
12 .7
2
232 192
212 28.3 2
14 8
11 4.2 2
195 327
261 93.3 2
12 18
15 4.2 2
286 195
240 64.3 2
003342
003343
APPENDIX 4
Individual Clinical Chemistry Data
Females
Day 546
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS
ANIMAL NUMBER
CA MG/DL
I PHOS MG/DL
NA MMOL/L
K MMOL/L
CL MMOL/L
Group : 1
105529 105549
MEAN S.D. n
Group: 3
105539 105552
MEAN S.D. H
Group : 4
105533 105542
MEAN S.D. N
Dose Level : 0
10.1 10. L
5.2 5.6
10.1 .0u
2
5.4 .28 2
Dose Level : 0.15
9.8 10.2
5.4 4.9
10.0 .28 2
5.2 .35
2
Dose Level : 0.75
10.3 10.7
5.9 5.4
10.5 .28 2
5.6 .35 2
Dosage Unit: mg 'kg/day
150 5.1 108 152 .n 111
151
1.4 2
5.2 .14 2
110
2 2
Dosage Unit: mg /kg./day
155 5.4 112 157 6.1 117
156 1.4 2
5.8 .49 2
114 3
2
Dosage unit: mg /kg/day
159 5.6 115 165 6.7 124
162 4.2 2
6.2 .78 2
120 6 2
Covance 6329-223 3M Study No. T-6295.7
CO
o
003344
Appendix 4
Individual Clinical Urinalysis Data
Males
Day -27
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
ANIMAL NUMBER
U VOL ML
SP GR
U PH
Group i 1
105508 105517 105519 105520 105526 105527
MEAN S.D. N
Group: 2
105514 105515 105516 105521
MEAN S.D. N
Group: 3
105505 105510 105518 105523 105524 105528
MEAN S.D. N
Dose Level;: 0
37.0 28.0 47.0 75.0 32.0 30.0
1.025 1.032 1.025 1.018
1.030 1.023
41.5 17.76
6
1.026 .0050 6
Dose Level:
67.0 46.0
52.0 45.0
1.019 1.023 1.020 1.023
52.5 10.15
4
1.021 .0021 4
Dose Level:: 0.15
228.0 52.0 93.0 43.0 46.0
125.0
1.007 1.025 1.020 1.026 1.025 1.013
97.8 71.41
6
1.019 .0078 6
Dosage
8.0 7.0 8.0 7.5 7.5 6.0
7.3 .75 6
Dosage
7.0 7.5 7.0 8.0
7.4 .48 4
Dosage
7.0 7.0 7.0 7.0 7.5 7.0
7.1 .20
6
637
Covance 6329-223 3M T-6295.7
Appendix 4
Individual Clinical Urinalysis Data
Males
Day -27
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
ANIMAL NUMBER
U VOL ML
SP GR
U PH
Covance 6329-223 3M T-6295.7
Group: 4 Dose Level:: 0.75
Dosaaggee Unit: mg/kg/day
105506
43.0
1.026
7.0
105507
59.0
1.022
7.5
105509
68.0
1.018
7.0
105511
173.0
1.008
7.0
105512
92.0
1.013
7.5
I
105522
66.0
1.022
7.0
MEAN S.D. N
83.5 46.63
6
1.018 .0066 6
7.2 .26 6
003345
638
Appendix 4
Individual Clinical Urinalysis Data
Males
Day -27
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
ANIMAL NUMBER
U PRO MG/DL
U GLU
U KET U BILI U BLOOD UROBILI
Group: 1
105508 105517 105519 105520 105526 105527
Group: 2
105514 105515 105516 105521
Group: 3
105505 105510 105518 105523 105524 105528
Group: 4
105506 105507 105509 105511 105512 105522
Dose Level : 0
0_ 10 00+ 10 + 0
Dose Level: 0.03
0_ 010 10
Dose Level : 0.15
010 30 + 10 10 0
Dose Level: 0.75
10 010 0010 -
Dosage Unit: mg/kg/day
+++ _
+++
-
--
+++ +-
++
+++
-
Dosage Unit: mg/kg/day
__
_
- --
-+
--
Dosage Unit: mg/kg/day
__
---
--
M* --
-
+++
-
-
"
Dosage Unit: mg/kg/day
_ -- ---
--
+ ++
-
-
+
-
_
-
-
-
-
_
-
-
_
-
_
_ _ -
Covance 6329-223 3M T-6295.7
003346
639
ANIMAL NUMBER
Appendix 4
Individual Clinical Urinalysis Data
Males
Day -27
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
RBC
WBC
EPITH
BACT
CASTS CRYSTALS CRYSTALS
PER HPF PER HPF PER HPF PER HPF PER LPF PER LPF1 PER LPF2
URINE APP1
COMMENTS
Covance 6329-223 3M T-6295.7
Group: 1
105508 105517 105519 105520 105526 105527
Dose Level: 0
00 00 00 00 00 00
Dosage Unit: mg/kg/day
030 230 030 120 120 010
2B4D 2B4D 4B4E 4B4D 4B3D 4B3E
0
0 0 0
0 0
DK _
DK PQ
CL
BK CK
BK
Group: 2 Dose Level: 0.03
Dosage Unit: mg/kg/day
105514 105515
0 0
0 0
1 0
3 3
0 0
4B2E 4B4D
0 4E
CK CL
_ _
105516
0
0
0
3
0
4B2D
0
CK
105521
0
0
0
3
0
4B4D
0
BL -
Group: 3 Dose Level : 0.15
Dosage Unit: mg/kg/day
105505 105510
0 0
0 0
1 0
2 3
0 0
3B 4B4D
0 4E
BK BL
_ _
105518 105523 105524
0 0 0
0 0 0
4 0 0
3 3 3
0 0 0
4B 4B2D 3B4D
0 0 0
DL BL CK
_ _
105528
0
0
1
3
0
4B 0
BK -
Group: 4
105506 105507 105509 105511 105512 105522
Dose Level: 0.75
20 01 01 00 00 01
Dosage Unit: mg/kg/day
130 030 430 130 130 120
2B2D 4B4D 4B1E 4B 2B
2B
0 0 0 0 0 0
CK _
CL Q BK Q BK Q BK
BJ -
frncoo
640
003348
Appendix 4
Individual Clinical Urinalysis Data
Females
Day -27
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOSi T-6295) IN CYNOMOLGUS MONKEYS
ANIMAL NUMBER
U VOL ML
SP GR
U PH
Group: 1
105529 105530 105531 105535 105544 105549
MEAN S.D. N
Group: 2
105537 105541 105547 105550
MEAN S.D. N
Group : 3
105532 105538 105539 105545 105548 105552
MEAN S.D. N
Dose Level:; 0
52.0 100.0
57.0 45.0
240.0 50.0
1.017 1.020 1.020 1.023 1.007 1.023
90.7 75.84
6
1.018 .0060 6
Dose Level:i 0.03
225.0 48.0 45.0 52.0
1.007 1.023 1.024 1.023
92.5
88.38 4
1.019 .0082 4
Dose Level:: 0.15
140.0 61.0 53.0 62.0 64.0 51.0
1.012 1.023 1.026 1.018
1.020 1.025
71.8 33.80
6
1.021 .0052 6
Dosaaggee Unit: mg/kg/day
7.0 7.0
7.5 7.0
7.5 8.0
7.3 .41 6
Dosage
mg/kg/day
7.5 7.0 7.0 7.0
7.1 .25 4
Dosaaggee Unit: mg/kg/day
8.0 7.5 8.0 7.0 8.0 8.0
7.8 .42 6
641
Covance 6329-223 3M T-6295.7
Appendix 4
Individual Clinical Urinalysis Data
Females
Day -27
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
ANIMAL NUMBER
U VOL ML
SP GR
U PH
Covance 6329-223 3M T-6295.7
Group : 4 Dose Level:r 0.75
Dosage
105533
35.0
1.026
7.5
105534
59.0
1.024
8.0
I
105536
64.0
1.023
7.5
105540
247.0
1.007
7.0
105542
72.0
1.019
7.0
105551
51.0
1.021
7.0
MEAN S.D. N
88.0 78.91
6
1.020 .0068 6
7.3 .41 6
003349
642
Appendix 4
Individual Clinical Urinalysis Data
Females
Day -27
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
ANIMAL NUMBER
U PRO MG/DL
U GLU
U KET U BILI U BLOOD UROBILI
Group: 1
105529 105530 105531 105535 105544 105549
Group : 2
105537 105541 105547 105550
Group: 3
105532 105538 105539 105545 105548 105552
Group: 4
105533 105534 105536 105540 105542 105551
Dose Level: 0
010 0000
Dose Level: 0.03
0_
010 0
Dose Level: 0.15
0 010 000
Dose Level: 0.75
10 _
0 0000-
Dosage Unit: mg/kg/day
++ _
--
--
++ -
--
_
+
-
-
+ "
Dosage Unit: mg/kg/day
_ _ +++
+-
-
- - ++
"
Dosage Unit: mg/kg/day
_
+-
--
++ +-
-
++
-
-
Dosage Unit : mg/kg/day
+++ _
_
---
- --
---
--
+-
-
-
_
-
"
_
-
-
-
_
-
Covance 6329-223 3M T-6295.7
000350
643
ANIMAL NUMBER
Appendix 4
Individual Clinical Urinalysis Data
Females
Day -27
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
RBC
WBC
EPITH
BACT
CASTS CRYSTALS CRYSTALS
PER HPF PER HPF PER HPF PER HPF PER LPF PER LPF1 PER LPF2
URINE APPI
COMMENTS
Covance 6329-223 3M T-6295.7
Group: 1 Dose Level: 0
Dosage Unit: mg/kg/day
105529
0
1
1
3
1H
3B4D
0
BK P
105530
0
0
0
3
0
4B 0
DL _
105531
0
0
1
3
0
4B4D
0
CK _
105535
0
0
0
3
0
2B2D
0
CL -
105544
0
0
2
3
0
4B 0
AK -
105549
0
0
0
1
0
4B1D
IE
BK
-
Group : 2
105537 105541 105547 105550
Dose Level: 0.03
00 01 00 00
Dosage Unit: mg/kg/day
130 130 030 12 0
4B4D 4B2D 2B 4B1E
0 0
0 0
BK _
DL _ DL _ CK -
Group: 3 Dose Level : 0.15
Dosage Unit: mg/kg/day
105532
0
0
2
2
0
1D4F
0
BJ _
105538
0
0
1
2
0
1B1E
IF
CK
_
105539
0
0
1
3
0
4B 0
CK _
105545
0
0
1
2
0
4B 0
CK P
105548
0
0
0
3
0
2B 0
CL _
105552
0
0
2
3
0
4B 0
CL -
Group: 4
105533 105534 105536 105540 105542 105551
Dose Level: 0.75
01 00 00 00 01 00
Dosage Unit: mg/kg/day
230 12 0 130 430 130 130
2B4D 4B4D 3B3D 0 4B1E 4B1D
0 0 0 0 0 0
DK _
CL CL _ AK _ CK _ CK -
003351
644
Appendix 4
Individual Clinical Urinalysis Data
Males
Day 37
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
ANIMAL NUMBER
U VOL ML
SP GR
U PH
Group: 1
105508 105517 105519 105520 105526 105527
MEAN S.D. N
Group : 2
105514 105515 105516 105521
MEAN S.D. N
Group: 3
105505 105510 105518 105523 105524 105528
MEAN S.D.
Dose Level :: 0
56.0 47.0 48.0 66.0
26.0 58.0
1.023 1.025 1.021 1.013
1.006 1.017
50.2 13.75
6
1.018 .0071
6
Dose Level:: 0.03
62.0 108.0
38.0 82.0
1.020 1.017 1.028 1.019
72.5 29.73
4
1.021 .0048 4
Dose Level:: 0.15
307.0 34.0
70.0 54.0 37.0 64.0
1.002 1.023 1.017 1.019 1.028 1.025
94.3 105.16
1.019 .0092
Dosage Unit: mg/kg/day
8.0 7.0 8.0 7.0 7.5 7.5
7.5 .45 6
Dosage Unit: mg/kg/day
7.0 7.5 8.0 7.5
7.5 .41 4
Dosage Unit: mg/kg/day
7.0 7.5 7.5 7.5 7.0 7.0
7.2 .27
Covance 6329-223 3M T-6295.7
Appendix 4
Individual Clinical Urinalysis Data
Males
Day 37
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
ANIMAL NUMBER
U VOL ML
SP GR
U PH
Group: 4
105506 105507 105509 105511 105512 105522
MEAN S.D. N
Dose Level : 0.75
50.0 52.0 36.0 110.0
146.0 80.0
1.023 1.026 1.023 1.008 1.007 1.018
79.0 42.12
6
1.018 .0082 6
Dosage
8.0 8.0 8.0 6.5 7.0 6.5
7.3 .75 6
Covance 6329-223 3M T-6295.7
003353
646
Appendix 4
Individual Clinical Urinalysis Data
Hales
Day 37
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
ANIMAL NUMBER
U PRO MG/DL
U GLU
U KET U BILI U BLOOD UROBILI
Group: 1
105508 105517 105519 105520 105526 105527
Group: 2
105514 105515 105516 105521
Group: 3
105505 105510 105518 105523 105524 105528
Group: 4
105506 105507 105509 105511 105512 105522
Dose Level: 0
0_ 00000-
Dose Level: 0.03
0_
0 .00-
Dose Level: 0.15
0_
00000
Dose Level: 0.75
0_ 00000-
Dosage Unit: mg/kg/day
+ ++
-
+++ + -
_
-
-
_ -
Dosage Unit: mg/kg/day
_ __
-----
-
Dosage Unit: mg/kg/day
__
--
+-
--
++ -
-
---
Dosage Unit: mg/kg/day
++
-
-
+ + +++
_ -
_ -
_ -
-
_
_
-
_
_ _ -
-
_
_ _ _ _ -
Covance 6329-223 3M T-6295.7
000354
647
ANIMAL NUMBER
Appendix 4
Individual Clinical Urinalysis Data
Males
Day 37
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
RBC
WBC
EPITH
BACT
CASTS CRYSTALS CRYSTALS
PER HPF PER HPF PER HPF PER HPF PER LPF PER LPF1 PER LPF2
URINE APPI
COMMENTS
Covance 6329-223 3M T-6295.7
Group: 1
105508 105517 105519 105520 105526 105527
Dose Level: 0
00 00 00 00 00 00
Dosage Unit : rog/kg/day
1 2 0 4D 1 2 0 - ID 0 2 0 3E3F 1 100 0 1 0 IBID 0 1 0 4D
0 0 0 0 0 0
BK _
CK BK BJ P
BJ BJ P
Group: 2 Dose Level: 0.03
Dosage Unit : mg/kg/day
105514
1
0
1
2
0
2E 0
BK PQ
105515
0
0
0
3
0
4B4D
0
BK P
105516
0
0
1
2
0
4B1D
0
CK -
105521
0
0
0
2
0
4B2D
IE
BL
-
Group : 3 Dose Level : 0.15
Dosage Unit: mg/kg/day
105505
0
0
0
0
0
IB 0
AJ Q
105510
0
0
0
3
0
4D 0
BK
105518
0
0
0
1
0
3D 0
BK PQ
105523
0
0
1
2
0
2D3E
0
BK Q
105524
0
1
1
1
0
0
0
CK
105528
0
0
0
2
0
4B1E
0
BK
Group: 4 Dose Level: 0.75
Dosage Unit: mg/kg/day
105506
0
0
1
2
0
0
0
BK P
105507
0
0
0
1
0
3B4D
0
BK Q
105509
0
0
1
1
0
0
0
BK Q
105511
0
0
0
3
0
IB 0
BJ Q
105512
0
0
0
3
0
2B 0
BJ
105522
0
0
0
2
0
0
0
BK PQ
003355
648
003356
Appendix 4
Individual Clinical Urinalysis Data
Females
Day 37
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
ANIMAL NUMBER
U VOL ML
SP GR
U PH
Group: 1
105529 105530 105531 105535 105544 105549
MEAN S.D. N
Group : 2
105537 105541 105547 105550
MEAN S.D. N
Group: 3
105532 105538 105539 105545 105548 105552
MEAN S.D. N
Dose Level:: 0
14.0 20.0 31.0 564.0 38.0 44.0
1.010 1.003 1.026 1.001
1.020 1.021
118.5 218.53
6
1.014 .0103 6
Dose Level:: 0.03
170.0 46.0 76.0 55.0
1.011 1.020 1.016 1.024
86.8 56.91
4
1.018 .0056 4
Dose Level:: 0.15
78.0 186.0
66.0 85.0 47.0 40.0
1.014 1.006 1.019 1.012 1.024 1.026
83.7 53.05
6
1.017 .0076 6
Dosage
8.5 8.0 8.0 7.5 8.0 8.0
8.0 .32 6
Dosage
7.5 8.0 8.0 7.5
7.8 .29 4
Dosage
7.5 7.5 7.0 7.5 8.0 7.5
7.5 .32 6
mg/kg/day mg/kg/day mg/kg/day
649
Covance 6329-223 3M T-6295.7
Appendix 4
Individual Clinical Urinalysis Data
Females
Day 37
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
ANIMAL NUMBER
U VOL ML
SP GR
U PH
Covance 6329-223 3H T-6295.7
Group: 4 Dose Level;: 0.75
Dosaggee Unit: mg/kg/day
105533
38.0
1.024
8.0
105534
32.0
1.026
8.5
I
105536
44.0
1.028
8.0
105540
417.0
1.003
8.0
105542
34.0
1.025
7.0
105551
36.0
1.026
7.0
MEAN S.D. N
100.2 155.27
6
1.022 .0094 6
7.8 .61 6
003357
650
Appendix 4
Individual Clinical Urinalysis Data
Females
Day 37
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
ANIMAL NUMBER
U PRO MG/DL
U GLU
U KET U BILI U BLOOD UROBILI
Group: 1
105529 105530 105531 105535 105544 105549
Group: 2
105537 105541 105547 105550
Group: 3
105532 105538 105539 105545 105548 105552
Group: 4
105533 105534 105536 105540 105542 105551
Dose Level: 0
0_ 10 0000
Dose Level: 0.03
0_ 000
Dose Level: 0.15
000000
Dose Level: 0.75
0_ 10 0000-
Dosage Unit: mg/kg/day
_-
--
--
-+-
_
++
-
+++ -
Dosage Unit : mg/kg/day
_
--
--
-
--
Dosage Unit: mg/kg/day
__
---
- --
--
-
-
-
-
-
Dosage Unit: mg/kg/day
+_+
-----
-
+++
-
-
---
_
-
-
_
-
_
"
-
Covance 6329-223 3M T-6295.7
003358
651
ANIMAL NUMBER
Appendix 4
Individual Clinical Urinalysis Data
Females
Day 37
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
RBC
WBC
EPITH
BACT
CASTS CRYSTALS CRYSTALS
PER HPF PER HPF PER HPF PER HPF PER LPF PER LPF1 PER LPF2
URINE APPI
COMMENTS
Covance 6329-223 3M T-6295.7
Group : 1
105529 105530 105531 105535 105544 105549
Group: 2
105537 105541 105547 105550
Group : 3
105532 105538 105539 105545 105548 105552
Group : 4
105533 105534 105536 105540 105542 105551
Dose Level: 0
00 00 01 00 00 01
Dose Level 0.03
00 00 00 00
Dose Level: 0.15
01 00 00 00 00 00
Dose Level : 0.75
01 00 00 00 01 01
Dosage Unit: mg/kg/day
210 030 02 0 110 02 0 030
Dosage Unit : mg/kg/day
12 0 12 0 010 010
Dosage Unit: mg/kg/day
12 0 210 030 130 030 110
Dosage Unit: mg/kg/day
130 110 010 120 110 12 0
1E2F 4B 3B4D 0 3B3D 1E1F
4B 4B4D 2D IB
4B2E 3B 4B3E 4B4D 3B1D 3B1D
3B3D 2B4D 4B1D 0 3D 4B1D
0 0 0 0 0 0
0 0 0 0
0 0 0 0 0 IE
IE 0 3E 0 0 0
BJ BLM CL AK BK BK
BK BK BK BK
BK BK BK BL BK BL
BK BK BL AK BK BK
P
-
-
_
-
P -
_
-
-
-
-
_
P
-
P
-
003359
652
003360
Appendix 4
Individual Clinical Urinalysis Data
Males
Day 62
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
ANIMAL NUMBER
U VOL ML
SP GR
U PH
Group : 1
105508 105517 105519 105520 105526 105527
MEAN S.D. N
Group : 2
105514 105515 105516 105521
MEAN S.D. N
Group : 3
105505 105510 105518 105523 105524 105528
MEAN S.D. N
Dose Level;: 0
40.0 67.0 54.0 65.0 179.0
60.0
1.025 1.017 1.017 1.014
1.010 1.022
77.5 50.66
6
1.018 .0054 6
Dose Leveli: 0.03
44.0 69.0 28.0 108.0
1.010 1.020 1.028 1.016
62.2
34.86 4
1.018 .0076 4
Dose Level !: 0.15
192.0 53.0
82.0 131.0
25.0 84.0
1.006 1.021 1.014 1.006 1.031 1.014
94.5 59.43
6
1.015 .0095 6
Dosage
8.0 8.0 8.0 7.5 8.0 8.5
8.0 .32 6
Dosage
8.5 8.0 7.5 8.0
8.0 .41 4
Dosage
8.0 8.0 8.0 7.5 8.0 7.0
7.8 .42 6
mg/kg/day rag/kg/day mg/kg/day
653
Covance 6329-223 3H T-6295.7
Appendix 4
Individual Clinical Urinalysis Data
Males
Day 62
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
ANIMAL NUMBER
U VOL ML
SP GR
U PH
Group: 4
105506 105507 105509 105511 105512 105522
MEAN S.D. N
Dose Level: 0.75
50.0 66.0 34.0
107.0 89.0 62.0
1.020 1.018 1.023 1.009 1.013 1.019
68.0 26.39
6
1.017
.0051 6
Dosage Unit: mg/kg/day
7.5 8.0 8.0 8.0 7.5 8.5
7.9 .38 6
Covance 6329-223 3M T-6295.7
003361
654
Appendix 4
Individual Clinical Urinalysis Data
Males
Day 62
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
ANIMAL NUMBER
U PRO MG/DL
U GLU
U KET U BILI U BLOOD UROBILI
Group: 1
105508 105517 105519 105520 105526 105527
Groups 2
105514 105515 105516 105521
Group: 3
105505 105510 105518 105523 105524 105528
Groups 4
105506 105507 105509 105511 105512 105522
Dose Levels 0
10 10 00010
Dose Levels 0.03
0_ 10 10 0
Dose Levels 0.15
0_ 00010 0-
Dose Levels 0.75
10 _ 10 10 0010 -
Dosage Units mg/kg/day
++ + +++ +
-
_
-
-
_
-
-
Dosage Units mg/kg/day
___
++ ++ --
-
-
Dosage Units mg/kg/day
__
-
-
+ +++ +
-
-
-
-
+++
-
-
Dosage Units mg/kg/day
+++
-
-
_
-
---
-
+++
-
-
-
+++
_
-
-
-
-
-
-
_
-
-
__
-
Covance 6329-223 3M T-6295.7
29i)9
655
ANIMAL NUMBER
Appendix 4
Individual Clinical Urinalysis Data
Males
Day 62
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
RBC
WBC
EPITH
BACT
CASTS CRYSTALS CRYSTALS
PER HPF PER HPF PER HPF PER HPF PER LPF PER LPF1 PER LPF2
URINE APP1
COMMENTS
Covance 6329-223 3M T-6295.7
Group: 1 Dose Level : 0
Dosage Unit: mg/kg/day
105508
0
0
0
3
0
2B3D
0
CK Q
105517
0
1
1
2
0
2B2D
0
CK
105519
0
0
1
1
0
2E 0
CK _
105520
0
0
1
2
0
2B3D
0
BK -
105526
0
0
1
2
0
2B 0
BJ -
105527
0
0
1
3
0
2B4D
0
CK -
Group: 2 Dose Level : 0.03
Dosage Unit: mg/kg/day
105514
0
0
1
2
0
105515
0
0
1
3
0
105516
0
0
1
2
0
105521
0
0
0
3
0
Group: 3 Dose Level : 0.15
Dosage Unit : mg/kg/day
2B1E 2B4D
4D 3B1D
0 0
0 0
AJ Q CK
CK P BK -
105505
0
1
0
3
0
4B1D
0
AK Q
105510
0
0
0
1
0
3B4D
IE
CK
105518
0
0
1
3
0
4B3D
0
BK _
105523
0
1
1
2
0
2B 0
AK -
105524
0
0
1
2
0
2B4D
0
CK P
105528
0
0
1
2
0
3B1E
0
BK P
Group: 4 Dose Level: 0.75
Dosage Unit: mg/kg/day
105506
0
0
1
1
0
4D 0
CK Q
105507
0
0
1
2
0
4D 0
CK PQ
105509
0
1
1
1
0
0
0
CK P
105511
0
0
1
1
0
2B1D
0
BK Q
105512
0
0
1
2
0
ID 0
BJ
105522
0
1
0
3
0
1B3D
0
BK -
003363
656
003364
Appendix 4
Individual Clinical Urinalysis Data
Females
Day 62
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
ANIMAL NUMBER
U VOL ML
SP GR
U PH
Group: 1
105529 105530 105531 105535 105544 105549
MEAN S.D. N
Group : 2
105537 105541 105547 105550
MEAN S.D. N
Group: 3
105532 105538 105539 105545 105548 105552
MEAN S.D. N
Dose Level : 0
62.0 68.0 31.0 195.0 60.0
30.0
1.020 1.022 1.024 1.005 1.016 1.026
74.3 61.32
6
1.019 .0076 6
Dose Levels: 0.03
97.0 18.0 50.0 49.0
1.015 1.028 1.018 1.021
53.5 32.58
4
1.020 .0056 4
Dose Level:: 0.15
98.0 56.0 47.0 98.0 30.0 45.0
1.010 1.022 1.022 1.016 1.028 1.020
62.3 28.86
6
1.020 .0061 6
Dosage
8.0 8.5 8.0 8.0 8.0 8.5
8.2 .26 6
Dosage
8.0 8.0 7.5 7.0
7.6 .48 4
Dosage
7.5 8.0 8.0 8.0 7.5 8.0
7.8 .26 6
mg/kg/day mg/kg/day mg/kg/day
657
Covance 6329-223 3M T-6295.7
Appendix 4
Individual Clinical Urinalysis Data
Females
Day 62
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
ANIMAL NUMBER
U VOL ML
SP GR
U PH
Group: 4
105533 105534 105536 105540 105542 105551
MEAN S.D. N
Dose Level: 0.75
45.0 115.0
42.0 158.0
99.0 27.0
1.020
1.011 1.024 1.010 1.007
1.030
81.0 51.27
6
1.017
.0091 6
Dosage Unit: mg/kg/day
7.5 8.0 7.5 8.0 7.5 7.0
7.6 .38 6
Covance 6329-223 3M T-6295.7
003365
658
Appendix 4
Individual Clinical Urinalysis Data
Females
Day 62
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
ANIMAL NUMBER
U PRO MG/DL
U GLU
U KET U BILI U BLOOD UROBILI
Group: 1
105529 105530 105531 105535 105544 105549
Group: 2
105537 105541 105547 105550
Group: 3
105532 105538 105539 105545 105548 105552
Group: 4
105533 105534 105536 105540 105542 105551
Dose Level : 0
10 _
10 00010
Dose Level: O'.03
10 _
10 10 10
Dose Level: 0.15
10 10 10 010 10
Dose Level: 0.75
10 _
010 0010 -
Dosage Unit: mg/kg/day
++++
-
+
-
++
_
+++
-
-
-
-
Dosage Unit: mg/kg/day
__
++++
-
++++
-
Dosage Unit: mg/kg/day
+_
-_
+++
-
++++ +++
_ _
-
Dosage Unit: mg/kg/day
+_
-
+-
-
_
__
+++
-
_
-
-
_ -
_
_ -
-
_
-
Covance 6329-223 3M T-6295.7
003366
659
ANIMAL NUMBER
Appendix 4
Individual Clinical Urinalysis Data
Females
Day 62
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
RBC
WBC
EPITH
BACT
CASTS CRYSTALS CRYSTALS
PER HPF PER HPF PER HPF PER HPF PER LPF PER LPF1 PER LPF2
URINE APP1
COMMENTS
Covance 6329-223 3m T-6295.7
Group: 1
105529 105530 105531 105535 105544 105549
Group: 2
105537 105541 105547 105550
Group: 3
105532 105538 105539 105545 105548 105552
Group: 4
105533 105534 105536 105540 105542 105551
Dose Level : 0
00 10 01 00 00 00
Dose Level: 0.03
00 01 01 01
Dose Level : 0.15
04 00 01 00 01 01
Dose Level : 0.75
11 00 01 01 01 01
Dosage Unit: mg/kg/day
12 0 130 120 12 0 110 130
Dosage Unit: mg/kg/day
120 13 0 11 0 210
Dosage Unit: mg/kg/day
210 120 210 110 130 020
Dosage Unit: mg/kg/day
120 230 110 130 130 130
4D 4B 2B3D 0 4D1E 2B1D
2B4D 4B4D 4B2D 2D
0 3B3D 4D 4B1D 4D 2B2D
4B2D 4D 3D1E IB 2B3D 2B4D
0 0 0 0 0 0
0 0 0 0
0 0 0 0 0 0
0 0 0 0 0 0
CK P CK CK _ BJ P BK CK -
BK P CK P CK P CK P
BJ P CK CK P BK CK P CK
CK __ BK P CK P BK AJ P CK P
003367
660
003368
Appendix 4
Individual Clinical Urinalysis Data
Males
Day 91
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
ANIMAL NUMBER
U VOL ML
SP GR
U PH
Group : 1
105508 105517 105519 105520 105526 105527
MEAN S.D. N
Group : 2
105514 105515 105516 105521 a
MEAN S.D. N
Group: 3
105505 105510 105518 105523 105524 105528
MEAN S.D. N
Dose Level;: 0
46.0
40.0 60.0 43.0 52.0 44.0
1.023 1.026 1.017 1.023 1.026 1.031
47.5 7.31 6
1.024 .0046 6
Dose Level:: 0.03
29.0 66.0
46.0 122.0
1.010 1.017
1.025 1.019
65.8 40.43
4
1.018 .0062 4
Dose Level:: 0.15
241.0 48.0
106.0 72.0 42.0 98.0
1.005 1.010 1.017 1.010 1.021 1.018
101.2 73.16 6
1.014 .0061 6
Dosage Unit: mg/kg/day
8.0 6.0 8.0 7.5 7.5 8.0
7.5 .77 6
Dosage Unit: mg/kg/day
8.0 8.0 7.5 7.5
7.8 .29 4
Dosage Unit: mg/kg/day
7.0 7.0 8.0 7.0 7.5 8.0
7.4 .49 6
a Sample collected on Day 92.
661
Covance 6329-223 3M T-6295.7
Appendix 4
Individual Clinical Urinalysis Data
Males
Day 91
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
ANIMAL NUMBER
U VOL ML
SP GR
U PH
Covance 6329-223 3H T-6295.7
Group: 4 Dose Level;! 0.75
Dosage Unit: mg/kg/day
105506
42.0
1.021
6.5
105507
28.0
1.030
8.0
'!
105509
48.0
1.021
8.0
105511
70.0
1.017
8.0
105512
82.0
1.010
6.0
105522
54.0
1.023
7.0
MEAN S.D. N
54.0 19.47
6
1.020 .0066 6
7.2 .88 6
Co
C..' CO
CS 662
003370
Appendix 4
Individual Clinical Urinalysis Data
Males
Day 91
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
ANIMAL NUMBER
U PRO MG/DL
U GLU
U KET U BILI U BLOOD UROBILI
Group: 1
105508 105517 105519 105520 105526 105527
Group: 2
105514 105515 105516 105521 a
Group: 3
105505 105510 105518 105523 105524 105528
Group: 4
105506 105507 105509 105511 105512 105522
Dose Level: 0
10 _
10 10 10 10 10 -
Dose
0 10 10 0
Level:
_
-
-
0.03
Dose Level: 0.15
0_
00010 0-
Dose Level : 0.75
10 _
10 00010 -
Dosage Unit : mg/kg/day
++++
+
++++
+
-
-
Dosage Unit: mg/kg/day
Dosage Unit: mg/kg/day
++ Dosage Unit: mg/kg/day
++++ ++ -
a Sample collected on Day 92.
663
Covance 6329-223 3M T-6295.7
ANIMAL NUMBER
Appendix 4
Individual Clinical Urinalysis Data
Males
Day 91
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
RBC
WBC
EPITH
BACT
CASTS CRYSTALS CRYSTALS
PER HPF PER HPF PER HPF PER HPF PER LPF PER LPF1 PER LPF2
URINE APP1
COi
Group: 1 Dose Level : 0
Dosage Unit: mg/kg/day
105508
0
0
0
3
0
3D2F
0
CK
105517
0
0
2
3
0
4B 0
CK P
105519 105520 105526
0 0 0
0 0 0
0 0 0
3 3 2
0 0 0
3B1D 4B4D
1B4D
IF IE 0
BK BK CK
_ _
105527
0
0
0
2
0
4B4D
3E
CL
-
Group: 2 Dose Level : 0.03
Dosage Unit: mg/kg/day
105514 105515 105516 105521 a
Group: 3
00 00 00 00
Dose Level: 0.15
030 030 130 010
Dosage Unit: mg/kg/day
4B2E 4B1D ID 4B2E
0 0 0
0
BK Q
BK CK
_
CK Q
105505 105510
0 0
0 1
1 0
2 3
0 0
00 3B 0
AJ PQ BK PQ
105518
0
0
0
3
0
2B1E
0
BL
105523
0
1
0
3
0
4B 0
AK PQ
105524
0
0
1
2
0
0
0
CK P
105528
0
0
0
2
0
3B2E
IF
BK
Q
Group: 4 Dose Level: 0.75
Dosage Unit : mg/kg/day
105506
0
1
1
2
0
0
0
CK PQ
105507 105509
0 0
0 0
0 0
1 3
0 0
4B4D IB
IE 0
CIi BJ
_
105511
0
0
0
2
0
3B1E
0
BL Q
105512
0
0
1
2
0
0
0
BJ p
105522
0
0
1
1
0
4D 0
BJ Q
a Sample collected on Day 92,
Covance 6329-223 3m T-6295.7
003371
664
003372
Appendix 4
Individual Clinical Urinalysis Data
Females
Day 91
WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS ; T--6295) IN CYNOMOLGUS MONKEYS
ANIMAL NUMBER
U VOL ML
SP GR
U PH
Group: 1
105529 105530 105531 105535 105544 105549
MEAN S.D. N
Group: 2
105537 105541 105547 105550
MEAN S.D. N
Group: 3
105532 105538 105539 105545 105548 105552
MEAN S.D. N
Dose Level : 0
45.0 67.0 62.0 229.0 65.0 92.0
1.016 1.020 1.019 1.006
1.018 1.012
93.3 68.15
6
1.015 .0053
6
Dose Level: 0.03
104.0 31.0 60.0 64.0
1.017 1.021
1.014 1.021
64.8 30.02
4
1.018 .0034
4
Dose Level : 0.15
102.0 74.0
56.0 48.0 61.0 38.0
1.011 1.012
1.026 1.014 1.020 1.028
63.2 22.56
6
1.018 .0073 6
Dosage unit: mg/kg/day
8.0 8.0 8.0 8.0 8.0 8.0
8.0 .00 6
Dosage Unit: mg/kg/day
7.0 7.5 7.0 8.0
7.4 .48 4
Dosage Unit: mg/kg/day
8.0 7.0 7.5 6.5 8.0 8.0
7.5 .63 6
665
Covance 6329-223 3M T-6295.7
Appendix 4
Individual Clinical Urinalysis Data
Females
Day 91
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
ANIMAL NUMBER
U VOL ML
SP GR
U PH
Covance 6329-223 3M T-6295.7
Group: 4 Dose Level ;! 0.75
Dosag<
mg/kg/day
105533
30.0
1.025
8.0
105534
46.0
1.023
8.0
I
105536
268.0
1.005
8.0
105540
295.0
1.005
8.0
105542
38.0
1.022
7.0
105551
46.0
1.024
7.5
MEAN S.D. N
120.5 125.14
6
1.017 .0096 6
7.8 .42 6
003373
666
Appendix 4
Individual Clinical Urinalysis Data
Females
Day 91
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
ANIMAL NUMBER
U PRO MG/DL
U GLU
U KET U BILI U BLOOD UROBILI
Group: 1
105529 105530 105531 105535 105544 105549
Group : 2
105537 105541 105547 105550
Group: 3
105532 105538 105539 105545 105548 105552
Group: 4
105533 105534 105536 105540 105542 105551
Dose Level: 0
10 _
10 10 10 10 0
Dose Level : 0.03
0_
10 030 -
Dose Level: 0.15
10 _
010 010 - ' 10
Dose Level: 0.75
10 10 0010 10 -
Dosage Unit: mg/kg/day
___
- - +++ -------
-
Dosage Unit: mg/kg/day
__
+---* +++
Dosage Unit: mg/kg/day
___
+-+ --+-+--"
Dosage Unit: mg/kg/day
+_
--
---
++ --
_
-
-
_
-
_
-
_
-
-
Covance 6329-223 3M T-6295.7
003374
667
ANIMAL NUMBER
Appendix 4
Individual Clinical Urinalysis Data
Females
Day 91
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
RBC
WBC
EPITH
BACT
CASTS CRYSTALS CRYSTALS
PER HPF PER HPF PER HPF PER HPF PER LPF PER LPF1 PER LPF2
URINE APP1
COMMENTS
Covance 6329-223 3M T-6295.7
Group: 1 Dose Level : 0
Dosage Unit: mg/kg/day
105529
0
0
0
3
0
105530
4
0
0
3
0
105531
0
0
0
3
0
105535
0
0
1
3
0
105544
0
0
0
3
0
105549
0
0
1
3
0
Group : 2 Dose Level: 0.03
Dosage Unit: mg/kg/day
105537
0
0
1
2
0
105541
0
0
1
3
0
105547
0
0
0
3
0
105550
4
0
1
3
0
Group : 3 Dose Level : 0.15
Dosage Unit: mg/kg/day
105532
0
1
4
3
0
105538
0
0
2
3
0
105539
0
0
0
2
0
105545
0
0
1
1
0
105548
0
0
1
1
0
105552
0
0
1
1
0
Group: 4 Dose Level: 0.75
Dosage Unit: mg/kg/day
105533
0
3
1
3
0
105534
0
0
0
2
0
105536
0
0
1
2
0
105540
0
0
2
3
0
105542
0
2
1
3
0
105551
0
0
1
3
0
3B4D 3B4D 4B2E 2B1F 2B 2B1D
3BID 4B4D 3B1D 3B
1B4D 3D 4B2E 0 4B4D 4B1D
4D 4B4D 3D 0 2B2D 3B1D
0 0 0 0 0 IE
IE 1E1F 0 0
0 0 0 0 0 IE
0 0 0 0 0 0
BK BL BL BJ BL BK
BK BL BL CL
BK BK BL BK BL CL
CK BL AJ AK BK BL
_ _ _
-
_ _
P
P
_ _
-
-
P
_
_
P
003375
668
Appendix 4
Covance 6329-223 3M T-6295.7
Individual Clinical Urinalysis Data
Males
Day 153
*
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
ANIMAL NUMBER
U VOL ML
SP GR
U PH
Group : 1
105508 105517 105519 105520 105526 105527
MEAN S.D. N
Group : 2
105514 105515 105516 105521
MEAN S.D. N
Group: 3
105505 105510 105518 105523 105524 105528
MEAN S.D. N
Dose Level:: 0
68.0 76.0 210.0 34.0 320.0 80.0
1.017 1.013 1.004 1.019 1.005 1.021
131.3 110.42
6
1.013 .0072
6
Dose Level:: 0.03
56.0 46.0 34.0 84.0
1.017 1.020
1.028 1.017
55.0 21.32
4
1.020 .0052 4
Dose Level:: 0.15
360.0 92.0 66.0
140.0 44.0
125.0
1.004 1.009 1.014 1.008 1.022 1.011
137.8 114.54
6
1.011 .0062 6
Dosage
7.5 7.0 7.5 6.5 6.5 7.5
7.1 .49 6
Dosage
7.5 7.0 7.0 8.0
7.4 .48 4
Dosage
7.5 7.0 7.0 7.0 7.0 7.0
7.1 .20 6
mg/kg/day mg/kg/day mg/kg/day
003376
669
Appendix 4
Individual Clinical Urinalysis Data
Males
Day 153
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
ANIMAL NUMBER
U VOL ML
SP GR
U PH
Group : 4
105506 105507 105509 105511 105512 105522
MEAN S.D. N
Dose Level : 0.75
80.0 200.0
32.0 390.0
280.0 98.0
1.012 1.008 1.026 1.003 1.005 1.013
180.0 136.48
6
1.011 .0082 6
Dosage
7.0 7.5 6.0 7.0 7.5 7.5
7.1 .58 6
mg/kg/day
Covance 6329-223 3M T-6295.7
003377
670
Appendix 4
Individual Clinical Urinalysis Data
Males
Day 153
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
ANIMAL NUMBER
U PRO MG/DL
U GLU
U KET U BILI U BLOOD UROBILI
Group: 1
105508 105517 105519 105520 105526 105527
Group: 2
105514 105515 105516 105521
Group: 3
105505 105510 105518 105523 105524 105528
Group: 4
105506 105507 105509 105511 105512 105522
Dose Level : 0
0_
00000
Dose Level: 0.03
0 00-
0-
Dose Level: 0.15
0_ 00000"
Dose
0 0 10 0 0 0
Level:
_
-
0.75
Dosage Unit: mg/kg/day
_
++ -
-
-
++++ 4-
-
-
-
Dosage Unit: mg/kg/day
++ _
+
--
---
-*
Dosage Unit: mg/kg/day
___
--
+-
--
++ -
-
Dosage Unit: mg/kg/day
+++
-
++
-
_
-
-
---
-- -
_
-
-
-
-
_
-
"
_
_ -
Covance 6329-223 3M T-6295.7
003378
671
ANIMAL NUMBER
Appendix 4
Individual Clinical Urinalysis Data
Hales
Day 153
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
RBC
WBC
EPITH
BACT
CASTS CRYSTALS CRYSTALS
PER HPF PER HPF PER HPF PER HPF PER LPF PER LPF1 PER LPF2
URINE APP1
COMMENTS
Covance 6329-223 3M T-6295.7
Group: 1 Dose Level: 0
Dosage Unit: mg/kg/day
105508
0
0
1
3
0
105517
0
0
1
2
0
105519
0
0
0
2
0
105520
0
0
1
3
0
105526
0
0
1
3
0
105527
0
0
0
3
0
Group : 2 Dose Level : 0.03
Dosage Unit : mg/kg/day
4B 0 0 0 0 4B4D
0 0 0 0 0 0
BK Q BK P AJ _ BK _ AK
BL Q
105514
0
0
0
3
0
3B1D
IE
BK
PQ
105515
0
0
1
3
0
IBID
IE
BK
PQ
105516
0
0
1
3
0
4B1D
0
BK PQ
105521
0
0
1
3
0
4B4D
0
BL
Group: 3 Dose Level : 0.15
Dosage Unit: mg/kg/day
105505
0
0
1
3
0
105510
0
0
1
3
0
105518
0
0
0
3
0
105523
0
1
1
3
0
105524
0
0
1
2
0
105528
0
1
1
3
0
Group: 4 Dose Level : 0.75
Dosage Unit: mg/kg/day
0 0 4B 0 0 0
0 0 0 0 0 0
AK _ BK _ BK _ BK Q BK BK Q
105506
0
0
1
3
0
2B 0
BK Q
105507
0
0
0
2
0
0
0
AK
105509
0
1
1
3
0
0
0
BK P
105511
0
0
0
2
0
0
0
AK
105512
0
0
1
2
0
0
0
AK _
105522
0
0
1
3
0
0
0
BK -
6 C C 00
672
003380
Appendix 4
Individual Clinical Urinalysis Data
Females
Day 153
WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
ANIMAL NUMBER
U VOL ML
SP GR
U PH
Group : 1
105529 105530 105531 105535 105544 105549
MEAN S.D. N
Group : 2
105537 105541 105547 105550
MEAN S.D. N
Group : 3
105532 105538 105539 105545 105548 105552
MEAN S.D. N
Dose Level: 0
44.0 36.0
36.0 145.0 100.0 150.0
1.022 1.024
1.023 1.006 1.011 1.007
85.2 53.91
6
1.016 .0084 6
Dose Level: 0.03
110.0 40.0 26.0 66.0
1.013 1.020 1.017 1.016
60.5 36.93
4
1.016 .0029 4
Dose Level: 0.15
44.0 46.0 54.0 46.0 28.0 26.0
1.023 1.027
1.018 1.018 1.022 1.027
40.7 11.15
6
1.022 .0040
6
Dosage Unit: mg/kg/day
7.5 8.0 7.5 7.0 7.5 7.5
7.5 .32 6
Dosage Unit: mg/kg/day
7.0 7.0 6.5 7.5
7.0 .41 4
Dosage Unit: mg/kg/day
7.0 7.0 7.0 7.0 7.5 7.0
7.1 .20 6
673
Covance 6329-223 3M T-6295.7
Appendix 4
Individual Clinical Urinalysis Data
Females
Day 153
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
ANIMAL NUMBER
U VOL ML
SP GR
U PH
Group: 4
105533 105534 105536 105540 105542 105551
MEAN S.D. N
Dose Level:: 0.75
30.0 52.0 110.0 270.0 36.0 36.0
1.025 1.011 1.012 1.005 1.021
1.026
89.0 93.46
6
1.017 .0085 6
Dosage Unit: mg/kg/day
7.0 8.0 7.5 6.0 7.0 7.0
7.1 .66 6
Covance G329-223 3M T-6295.7
T8CEO0
674
Appendix 4
Individual Clinical Urinalysis Data
Females
Day 153
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
ANIMAL NUMBER
U PRO MG/DL
U GLU
U KET U BILI U BLOOD UROBILI
Group: 1
105529 105530 105531 105535 105544 105549
Group: 2
105537 105541 105547 105550
Group: 3
105532 105538 105539 105545 105548 105552
Group: 4
105533 105534 105536 105540 105542 105551
Dose Level : 0
10 _
10 0000-
Dose Level : 0.03
0_
30 10 0
Dose Level: 0.15
0_ 00010 0-
Dose Level: 0.75
0 00000-
Dosage Unit: mg/kg/day
+ _ +++
--
++-
--
-
Dosage Unit : mg/kg/day
+ ++ ++++ +
_
-
_
+++
-
-
Dosage Unit: mg/kg/day
+
+++ + ++ +++ +++
-
-
_ -
Dosage Unit: mg/kg/day
+++
-
-
+ ++ +
_
_ -
-
__
-
-
_
-
-
_ _ _ -
_ _ _ -
Covance 6329-223 3M T-6295.7
003352
675
ANIMAL NUMBER
Appendix 4
Individual Clinical Urinalysis Data
Females
Day 153
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
RBC
WBC
EPITH
BACT
CASTS CRYSTALS CRYSTALS
PER HPF PER HPF PER HPF PER HPF PER LPF PER LPF1 PER LPF2
URINE APPl
COMMENTS
Covance G329-223 3M T-6295.7
Group: 1 Dose Level : 0
Dosage Unit: mg/kg/day
105529
2
1
0
3
0
105530
0
1
0
3
0
105531
0
0
0
2
0
105535
0
0
1
2
0
105544
0
0
1
3
0
105549
0
0
2
3
0
Group: 2 Dose Level : 0.03
Dosage Unit : mg/kg/day
105537
0
0
1
3
0
105541
4
1
1
3
0
105547
0
1
1
3
0
105550
0
0
2
3
0
Group: 3 Dose Level : 0.15
Dosage Unit: mg/kg/day
105532
0
4
2
2
0
105538
0
0
1
1
0
105539
0
1
3
3
0
105545
0
0
2
3
0
105548
0
1
1
3
0
105552
0
0
1
3
0
Group: 4 Dose Level : 0.75
Dosage Unit: mg/kg/day
105533
0
1
1
3
0
105534
0
0
1
3
0
105536
0
1
1
2
0
105540
0
1
2
1
0
105542
0
2
1
3
0
105551
0
1
1
3
0
3B1D 4B4D 4B4D 0 4B 0
2B4D 0 3B2E 0
0 ID ID 4D 4B4D 4D
2B2D 2B4D 4B3D 0 2B4D 3B4D
0 0 2E4F 0 0 0
0 0 0 0
0 0 0 0 0 0
0 0 IE 0 0 0
BL BL BL BK BL BK
BK CK BL BK
BK CK BK BK BL CK
BK BK BL AK BK CK
_ _ P_
-
_
P P -
P P P P
_ _ _ _ _
-
0033S3
676
003384
Appendix 4
Individual Clinical Urinalysis Data
Males
Day 182
WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) :IN CYNOMOLGUS MONKEYS
ANIMAL NUMBER
U VOL ML
SP GR
U PH
Group: 1
105508 105517 105519 105520 105526 105527
MEAN S.D. N
Group : 2
105514 105515 105516 105521
MEAN S.D. N
Group : 3
105505 105510 105518 105523 105524 105528
MEAN S.D. N
Dose Level: 0
184.0 49.0 62.0
102.0 242.0
58.0
1.006 1.021 1.012 1.013 1.006 1.023
116.2 79.33 6
1.014 .0072 6
Dose Level: 0.03
94.0 52.0 54.0 102.0
1.014 1.019 1.018 1.016
75.5 26.20
4
1.017 .0022
4
Dose Level: 0.15
368.0 122.0
78.0 21.0 49.0 96.0
1.003 1.012
1.016 1.017 1.015 1.016
122.3 125.43
6
1.013 .0053 6
Dosage Unit: mg/kg/day
8.0 7.5 8.0 8.0 8.0 8.0
7.9 .20 6
Dosage Unit: mg/kg/day
8.0 7.5 8.0 8.0
7.9 .25 4
Dosage Unit: mg/kg/day
8.0 8.0 8.5 6.0 6.5 8.0
7.5 1.00
6
677
Covance 6329-223 3M T-6295.7
Appendix 4
Individual Clinical Urinalysis Data
Males
Day 182
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
ANIMAL NUMBER
U VOL ML
SP GR
U PH
Group: 4
105507 105511 105512 105522
MEAN S.D. N
Dose Level:: 0.75
280.0
96.0 36.0 72.0
1.005 1.017
1.018 1.012
121.0 108.83
4
1.013 .0059 4
Dosage Unit: mg/kg/day
7.5 8.0 6.5 7.0
7.2 .65 4
Covance 6329-223 3M T-6295.7
c
o (4 0> 00 01
678
Appendix 4
Individual Clinical Urinalysis Data
Males
Day 182
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
ANIMAL NUMBER
U PRO MG/DL
U GLU
U KET U BILI U BLOOD UROBILI
Group: 1
105508 105517 105519 105520 105526 105527
Group: 2
105514 105515 105516 105521
Group : 3
105505 105510 105518 105523 105524 105528
Group: 4
105507 105511 105512 105522
Dose Level : 0
10 _ 10 10 10 10 10
Dose Level: 0.03
10 _
10 10 10
Dose Level: 0.15
10 _ 10 10 10 10 10 "
Dose Level: 0.75
10 10 10 10
Dosage Unit: mg/kg/day
___
--
--
-
-
---
--
+
-
-
Dosage Unit: mg/kg/day
__
---
-- ~--
Dosage Unit: mg/kg/day
___
--
-
--
++ -~
-
Dosage Unit: mg/kg/day
__
-------
_
-
_
-
-
-
-
_
_ -
Covance 6329-223 3M T-6295.7
S 8 00
679
ANIMAL NUMBER
Appendix 4
Individual Clinical Urinalysis Data
Males
Day 182
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
RBC
WBC
EPITH
BACT
CASTS CRYSTALS CRYSTALS
PER HPF PER HPF PER HPF PER HPF PER LPF PER LPF1 PER LPF2
URINE APPI
COMMENTS
Covance 6329-223 3M T-6295.7
Group : 1 Dose Level: 0
Dosage Unit: mg/kg/day
105508
0
0
0
3
0
105517
0
0
0
2
0
105519
0
0
0
3
0
105520
0
0
0
3
0
105526
0
1
0
3
0
105527
0
0
0
3
0
Group: 2 Dose Level : 0.03
Dosage Unit: mg/kg/day
105514
0
0
0
2
0
105515
0
0
0
3
0
105516
0
0
1
3
0
105521
0
0
0
3
0
Group: 3 Dose Level: 0.15
Dosage Unit : mg/kg/day
105505
0
0
0
3
0
105510
0
0
1
3
0
105518
0
0
0
3
0
105523
0
0
0
1
0
105524
0
0
0
3
0
105528
0
0
0
1
0
Group: 4 Dose Level: 0.75
Dosage Unit : mg/kg/day
105507
0
0
0
1
0
105511
0
0
1
2
0
105512
0
0
0
2
0
105522
0
0
1
2
0
2B1E 3B3D 4B 3B1D 2B 4B4D
2B2E 4B1E 2B 4B
2B 2B1E 4B4D IB 0 4B1E
0 4B 0 2D
0 0 0 0 0 0
0 0 0 0
0 0 0 0 0 0
0 0 0 0
BK BL BK BL AK BL
BK BK BK BL
AK BK BK BJ BK BL
AJ BK BJ BK
DOO
003387
680
003388
Appendix 4
Individual Clinical Urinalysis Data
Females
Day 182
WEEK CAPSULE 1TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
ANIMAL NUMBER
U VOL ML
SP GR
U PH
Group : 1 105529 105530 105531 105535 105544 105549
MEAN S.D. N
Group: 2
105537 105541 105547 105550
MEAN S.D. N
Group: 3
105532 105538 105539 105545 105548 105552
MEAN S.D. N
Dose Level : 0
50.0
1.020
62.0
1.015
57.0
1.023
159.0
1.009
86.0
1.017
100.0
1.013
85.7 40.59
6
1.016 .0050 6
Dose Level: 0.03
108.0 38.0 95.0 64.0
1.013 1.020 1.009 1.020
76.2
31.48 4
1.016 .0054 4
Dose Level: 0.15
118.0 61.0 70.0 66.0 82.0 43.0
1.010 1.021 1.022
1.013 1.014
1.023
73.3 25.33
6
1.017 .0055 6
Dosage Unit: mg/kg/day 8.0 8.0 8.5 8.0 8.0 8.0
8.1 .20 6
Dosage Unit: mg/kg/day
7.0 7.5 8.0 8.0
7.6 .48 4
Dosage Unit: mg/kg/day
8.0 8.0 8.0 7.5 8.0 8.0
7.9 .20 6
681
Covance 6329-223 3M T-6295.7
Appendix 4
Individual Clinical urinalysis Data
Females
Day 182
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
ANIMAL NUMBER
U VOL ML
SP GR
U PH
Group: 4
105533 105534 105536 105540 105542 105551
MEAN S.D. N
Dose Level:i 0.75
47.0 82.0 72.0 450.0 84.0 56.0
1.016 1.015 1.017 1.003 1.018 1.018
131.8 156.54
6
1.014 .0058 6
Dosagi
7.5 8.0 8.0 7.5 8.0 8.0
7.8 .26 6
mg/kg/day
Covance 6329-223 3M T-6295.7
0033S9
682
Appendix 4
Individual Clinical Urinalysis Data
Females
Day 182
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
ANIMAL NUMBER
U PRO MG/DL
U GLU
U KET U BILI U BLOOD UROBILI
Group: 1
105529 105530 105531 105535 105544 105549
Group : 2
105537 105541 105547 105550
Group: 3
105532 105538 105539 105545 105548 105552
Group: 4
105533 105534 105536 105540 105542 105551
Dose Level : 0
10 _
10 10 10 10 10
Dose Level: 0.03
10 _
10 _ 10 10
Dose Level: 0.15
10 _
10 10 10 10 10
Dose Level: 0.75
30 _ 10 10 10 10 10 -
Dosage Unit: mg/kg/day
__
- --
--_ ---
-- -
+
Dosage Unit: mg/kg/day
++ _
++ -
--
_
-
"
Dosage Unit: mg/kg/day
__
-- -------
*
Dosage Unit: mg/kg/day
+++
_ -
_
-
+++ +
-
-
-
--
_
-
-
_
_ -
_
_ -
-
_
_ -
Covance 6329-223 3M T-6295.7
06PC00
683
ANIMAL NUMBER
Appendix 4
Individual Clinical Urinalysis Data
Females
Day 182
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
RBC
WBC
EPITH
BACT
CASTS CRYSTALS CRYSTALS
PER HPF PER HPF PER HPF PER HPF PER LPF PER LPF1 PER LPF2
URINE APP1
COMMENTS
Covance 6329-223 3M T-6295.7
Group: 1
105529 105530 105531 105535 105544 105549
Dose Level : 0
00 00 00 00 00 01
Dosage Unit: mg/kg/day
130 030 1 3 1G 130 130 130
4B1D 4B2D 4B1E
4D 4B 2B1D
0 0 0 0
0 0
BL BL BK BK BL
_ _ _ _
BK -
Group: 2
105537 105541 105547 105550
Dose Level : 0.03
01 01 00 00
Dosage Unit: mg/kg/day
130 130 130 13 0
3B2E 3B1E 4B 4B1E
0 0 0
0
BK BL
_ _
BK P
BL
Group ! 3 Dose Level : 0.15
Dosage Unit: mg/kg/day
105532 105538 105539
0 0 0
3 0 0
0 1 0
3 2 1
0 0 0
2B2E 4B2E 3B1E
0 IF 0
BK BL BL
_ _
105545 105548
0 0
0 0
1 1
2 3
0 0
2B2D 3B
0 0
BK BK
_
105552
0
1
1
3
0
3B3D
0
BL -
Group: 4 Dose Level: 0.75
Dosage Unit : mg/kg/day
105533 105534 105536 105540 105542 105551
2 0 0 0 0 0
0 1 0 0 0 1
1 1 2 1 0 1
3 3 2 2 3 3
0 0 0 0 0 0
0 3B 4B3D
IB
4B 3B3D
0 0 0 0 0 0
BK BL BL AK BK BL
_ _ _ _ -
003391
684
APPENDIX 4
Individual clinical Urinalysis Data
Males
Day 217
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS
ANIMAL NUMBER
U VOL ML
SP GR
U PH
Group : 1
105520 105526
MEAN S.D. N
Group: 3
105505 105523
MEAN S.D. N
Group : 4
105511 105522
MEAN S.D. N
Dose Level: 0
162.0 197.0
1.010 1.010
179.5 24.75 2
1.010 .0000
2
Dose Level: 0.15
296.0 183.0
1.005 1.009
239.5 79.90 2
1.007 .0028
2
Dose Level: 0.75
62.0 113.0
1.011 1.015
87.5 36.06
2
1.013 .0028 2
Dosage Unit: mg/kg/day
7.5 7.0
7.2 .35 2
Dosage Unit: mg/kg/day
7.5 7.5
7.5 .00 2
Dosage Unit: mg/kg/day
6.5 7.5
7.0 .71 2
Covance 6329-223 3M Study No. T-6295.7
C6PC00
APPENDIX 4
Individual Clinical Urinalysis Data
Males
Day 217
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS
ANIMAL NUMBER
U PRO MG/DL
U GLU
U KET U BILI U BLOOD UROBILI
Group : 1
105520 105526
Group : 3
105505 105523
Group : 4
105511 105522
Dose Level: 0
0 0
Dose Level: 0.15
0 0
Dose Level: 0.75
0 0
Dosage Unit: mg/kg/day --
Dosage Unit: mg/kg/day -
-
Dosage Unit: mg/kg/day -+
Covance 6329-223 3M Study No. T-6295.7
ANIMAL NUMBER
APPENDIX 4
Individual Clinical Urinalysis Data
Males
Day 217
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS
RBC
WBC
EPITH
BACT
CASTS CRYSTALS
PER HPF PER HPF PER HPF PER HPF PER LPF PER LPF1
URINE APP1
COMMENTS
Covance 6329-223 3M Study No. T-6295.7
Group : 1 Dose Level .- 0
Dosage Unit: mg/kg/day
105520
i)
1
0
1
0
4B BK _
105526
0
0
1
2
0
4B BJ Q
Group: 3 Dose Level: 0.15
Dosage Unit: mg/kg/day
105505
0
0
0
2
0
2B AJ _
105523
U
0
0
2
0
2B AK Q
Group : 4 Dose Level : 0.75
Dosage Unit: mg/kg/day
105511
0
0
1
3
0
3B BK _
105522
0
0
0
3
0
3B BK -
003394
003395
APPENDIX 4
Individual Clinical Urinalysis Data
Females
Day 217
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS
ANIMAL NUMBER
U VOL ML
SP GR
U PH
Group: i
105529 105549
MEAH S.D. N
Group: 3
105539 105552
MEAN S.D. N
Group : 4
105533 105542
MEAN S.D. N
Dose Level :: 0
88.0 198.0
1.020 1.009
143.0 77.78 2
1.014 .0078 2
Dose Level: 0.15
178.0 64.0
1.015 1.015
121.0 80.61 2
1.015 .0000 2
Dose Level : 0.75
63.0 115.0
1.015 1.015
89.0 36.77
2
1.015 .0000 2
Dosage Unit: mg/kg/day
8.0 7.5
7.8 .35 2
Dosage Unit: mg/kg/day
7.5 7.0
7.2 .35 2
Dosage Unit: mg/kg/day
7.0 8.0
7.5 .71 2
Covance S329-223 3M Study No. T-6295.7
APPENDIX 4
Individual Clinical Urinalysis Data
Females
Day 217
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS
ANIMAL NUMBER
U PRO MG/DL
U GLU
U KET U BILI U BLOOD UROBILI
Covance 6329-223 3M Study No. T-6295.7
Group : 1
105529 105549
Dose Level: 0
0_ 0-
Dosage Unit: mg/kg/day
__
-+
_
-
!
Group : 3 Dose Level: 0.15
Dosage Unit: mg/kg/day
105539 105552
10 10
_
-
_
+
-M-+ --
Group : 4
105533 105542
Dose Level : 0.75
0_ 0-
Dosage Unit: mg/kg/day
+_
--
-
9Greoo
ANIMAL NUMBER
APPENDIX 4
Individual Clinical Urinalysis Data
Females
Day 217
26-WEEK CAPSULE TOXICITY :STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T- 6295) IN CYNOMOLGUS
RBC
WBC
EPITH
BACT
CASTS CRYSTALS
PER HPF PER HPF PER HPF PER HPF PER LPF PER LPF1
URINE APPI
COMMENTS
Covance 6329-223 3M Study No. T-6295.7
Group : 1 Dose Level : 0
Dosage Unit: mg/kg/day
105529
0
0
1
3
0
105549
0
0
0
3
0
Group : 3 Dose Level: 0.15
Dosage Unit: mg/kg/day
105539
4
0
1
3
0
105552
0
0
1
3
0
Group : 4 Dose Level : 0.75
Dosage Unit: mg/kg/day
105533
0
0
1
3
0
105542
0
0
0
3
0
4B 3B
4B3E 4B
4B 3B
CK AK
BK BK
BK BK
-
"
_
-
P -
003397
003398
APPENDIX 4
Individual Clinical Urinalysis Data
Males
Day 245
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS
ANIMAL NUMBER
U VOL ML
SP GR
U PH
Group: 1
105520 105526
MEAN S.D. N
Group: 3
105505 105523
MEAN S.D. N
Group : 4
105511 105522
MEAN S.D. N
Dose Level:: 0
202.0 189.0
1.008 1.010
195.5 9.19 2
1.009 .0014 2
Dose Level : 0.15
290.0 102.0
1.005 1.014
196.0 132.94
2
1.010 .0064 2
Dose Level : 0.75
62.0 104.0
1.014 1.020
83.0 29.70
2
1.017 .0042 2
Dosage Unit: mg/kg/day
7.5 8.0
7.8 .35 2
Dosage Unit: mg/kg/day
7.5 7.5
7.5 .00 2
Dosage Unit: mg/kg/day
7.5 8.0
7.8 .35 2
Covance 6329-223 3M Study No. T-6295.7
003399
APPENDIX 4
Individual Clinical Urinalysis Data
Males
Day 245
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS
ANIMAL NUMBER
U PRO MG/DL
U GLU
U KET U BILI U BLOOD UROBILI
Group: 1
105520 105526
Group: 3
105505 105523
Group: 4
105511 105522
Dore Level : 0
0_
0
Dore Level : 0.15
0_ 0-
Dore Level : 0.75
0_
10 -
Dosage Unit: mg/kg/day
__
*"
Dosage Unit: mg/kg/day
_
~--
Dosage Unit: mg/kg/day
--
_
-
-
_
-
Covance 6329-223 3M Study No. T-6295.7
ANIMAL NUMBER
APPENDIX 4
Individual Clinical Urinalysis Data
Males
Day 245
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS
RBC
WBC
EPITH
BACT
CASTS CRYSTALS CRYSTALS
PER HPF PER HPF PER HPF PER HPF PER LPF PER LPF1 PER LPF2
URINE APP1
Covance 6329-223 3M Study No. T- 6295.7
COMMENTS
Group: 1 Dose Level: 0
Dosage Unit: mg/kg/day
105520
0
0
1
3
0
105526
O
0
0
3
0
Group: 3 Dose Level: 0.15
Dosage Unit: mg/kg/day
105505
0
0
0
3
0
105523
0
1
1
2
1H
Group: 4 Dose Level: 0.75
Dosage Unit: mg/kg/day
105511
0
0
1
2
0
105522
0
0
0
3
0
0 ID
0 2B2F
3D 4B
0 0
0 0
0 0
AJ Q AJ
AJ _
AJ PQ
BJ _
BL -
003400
003401
APPENDIX 4
Individual Clinical Urinalysis Data
Females
Day 245
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS
ANIMAL NUMBER
U VOL ML
SP GR
U PH
Group : 1
105529 105549
MEAN S.D. N
Group: 3
105539 105552
MEAN S.D. N
Group : 4
105533 105542
MEAN S.D. N
Dose Level:: 0
46.0 188.0
1.026 1.010
117.0 100.41
-
1.018 .0113 2
Dose Level: 0.15
176.0 87.0
1.015 1.018
131.5 62.93 2
1.016 .0021 2
Dose Level: 0.75
57.0 126.0
1.014 1.019
91.5 48.79
2
1.016 .0035 2
Dosage Unit : mg/kg/day
8.0 8.0
8.0 .00 2
Dosage Unit : mg/kg/day
7.0 7.5
7.2 .35 2
Dosage Unit : mg/kg/day
7.5 8.0
7.8 .35 2
Covance 6329-223 3M Study No. T-6295.7
003402
APPENDIX 4
Individual Clinical Urinalysis Data
Females
Day 245
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;; T-6295) IN CYNOMOLGUS
ANIMAL NUMBER
U PRO MG/DL
U GLU
U KET U BILI U BLOOD UROBILI
Group : i
105529 105549
Dose Level : 0
10 _ 0
Dosage Unit:: mg/kg/day
__
--
Group : 3 Dore Level : 0.15
Dosage Unit: mg''kg/day
105539
0
_
_
105552
0
-
-
_
-
Group: 4 Dose Level : 0.75
Dosage Unit: mg/kg/day
105533 105542
10 0
-
+__
---
_
Covance 6329-223 3M Study No. T-6295.7
ANIMAL
NUMBER
APPENDIX 4
Individual Clinical Urinalysis Data
Females
Day 245
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTAHE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS
RBC
WBC
EPITH
BACT
CASTS CRYSTALS CRYSTALS
PEP. HPF PER HPF PER HPF PER HPF PER LPF PER LPFi PER LPF2
URINE APP1
covance 6329-223 3M study No. T-6295.7
COMMENTS
Group: 1 Dos Level: 0
Dosage Unit: mg/kg/day
105529
0
0
0
3
0
3BlD
IE
EK
105549
0
0
1
3
0
2B 0
BJ -
Group: 3 Dos Level: 0.15
Dosage Unit: mg./kg/day
105539
0
0
1
3
0
105552
0
0
1
1
0
IB 4B1E
0 0
BJ _
BL -
Group: 4 Dose Level: 0.75
Dosage Unit: mg/kg/day
105533
0
11
3
0
2B1D
0
BK _
105542
0
0
1
2
0
3B2E
2F
BL
-
003403
003404
APPENDIX 4
Individual Clinical Urinalysis Data
Males
Day 274
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS
ANIMAL NUMBER
U VOL ML
SP GR
U PH
Group : 1
105520 105526
MEAN S.D. N
Group: 3
105505 105523
MEAN S.D. N
Group: 4
105511 105522
MEAN S.D. N
Dose Level !: 0
248.0 320.0
1.004 1.003
284.0 50.91 2
1.004 .0007 2
Dose Level :: 0.15
354.0 114.0
1.004 1.010
234.0 169.71
2
1.007 .0042 2
Dose Level : 0.75
32.0 103.0
1.026 1.011
67.5 50.20
2
1.018 .0106 2
Dosage unit: mg/kg/day
6.5 7.0
6.8 .35 2
Dosage Unit: mg/kg/day
7.5 7.0
7.2 .35 2
Dosage Unit : mg/kg/day
6.5 7.5
7.0 .71 2
Covance 6329-223 3M Study No. T-6295.7
003405
APPENDIX 4
Individual Clinical Urinalysis Data
Males
Day 274
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOP.OOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-629S) IN CYHOMOLGUS
ANIMAL NUMBER
U PRO MG/DL
U GLU
U KET U BILI U BLOOD UROBILI
Group : 1
105520 105526
Dose Level: 0
I.) _ 0-
Dosage Unit: met/kg /day
__
--
Group : 3 Dose Levelt 0.15
Dosage Unit : mg/kg/day
105505
0
_
_
_
105523
10
-
- +++
Group: 4 Dose Level : 0.75
Dosage Unit : mg"kg/day
105511
10
_
105522
0
-
-
_
_
_
-
-
_
Covance 6329-223 3M Study No. T-6295.7
ANIMAL NUMBER
APPENDIX 4
Individual Clinical urinalysis Data
Males
Day 274
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYHOMOLGUS
RBC
WBC
EPITH
BACT
CASTS CRYSTALS
PER HPF PER HPF PER HPF PER HPF PER LPF PEP. LPF1
URINE APP1
COMMENTS
Covance 6329-223 3M Study No. T- 6295.7
Group: 1
105520 105526
Group: 3
105505 105523
Group: 4
105511 105522
Dose Level: 0
00 00
Dose Level: 0.15
00 00
Dose Level: 0.75
00 00
Dosage Unit: mg/kg/day
030 120
Dosage Unit: mg/kg/day
030 030
Dosage Unit: mg/kg/day
020 030
0 0
0 0
1B4E IB
AJ AJ
AJ BJ
BJ BJ
..
_
PQ
_
-
003406
003407
APPENDIX 4
Individual Clinical Urinalysis Data
Females
Day 274
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-62951 IN CYNOMOLGUS
ANIMAL HUMBER
U VOL ML
SP GR
U PH
Group : 1
105529 105549
MEAN S.D. U
Group : 3
105539 105552
MEAN S.D. N
Group : 4
105533 105542
MEAN S.D. N
Dose Level : 0
118.0 165.0
1.007 1.005
141.5 33.23
2
1.006 .0014 2
Dose Level : 0.15
90.0 37.0
1.016 1.023
63.5 37.48
2
1.020 .0050 2
Dose Level : 0.75
23.0 106.0
1.011 1.010
64.5 58.69
2
1.010 .0007 2
Dosage Unit : mg/kg/day
7.5 8.0
7.8 .35 2
Dosage Unit : mg/kg/day
7.5 7.5
7.5 .00 2
Dosage Unit: mg/kg/day
8.0 6.5
7.2 1.06
2
Covance 6329-223 3M Study No. T-6295.7
003408
APPENDIX 4
Individual Clinical Urinalysis Data
Females
Day 274
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTAHE SULFONIC ACID POTASSIUM SALT (PFOS; T-629S) IN CYHOMOLGUS
ANIMAL NUMBER
U PRO MG/DL
U GLU
u KET U BILI U BLOOD UROBILI
Group: 1
105529 105549
Group: 3
105539 105552
Group: 4
105533 105542
Do? Level: 0
0_
0-
Do?e Level: 0.15
10 _
10 -
Dose Level: 0.75
10 _
0-
Dosage Unit: mg<'kg/day
_
--
Dosage Unit: mg 'kg- day
__
++ -
Dosage Unit: mg /kg day
_
++ -
-
_
_
_
Covance 6329-223 3M Study No. T-6295.7
ANIMAL NUMBER
APPENDIX 4
Individual Clinical Urinalysis Data
Females
Day 274
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS
RBC
WBC
EPITH
BACT
CASTS CRYSTALS
PER HPF PEP. HPF PER HPF PER HPF PEP. LPF PER LPF1
URINE APP1
COMMENTS
Covance 6329-223 3M Study No. T-6295.7
Group: 1
105529 105549
Group: 3
105539 105552
Group: 4
105533 105542
Dose Level: 0
00 00
Dose Level: 0.15
01 00
Dose Level: 0.75
00 00
Dosage Unit: mg/kg .'day
13 13
0 0
Dosage Unit: mg/kg/day
13 13
0 0
Dosage Unit: mg ./kg/day
03 0 13 0
0 ID
1B2E 4B
4B IB
AJ AJ
BJ BL
BL BJ
P
00349
003410
APPENDIX 4
Individual clinical Urinalysis Data
Males
Day 322
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS
ANIMAL NUMBER
U VOL ML
SP GR
U PH
Group: 1
105520 105526
MEAN S.D. N
Group : 3
105505 105523
MEAN S.D. N
Group: 4
105511 105522
MEAN S.D. N
Dose Level:: 0
116.0 476.0
1.015 1.002
296.0 254.56
2
1.008 .0092 2
Dose Level: 0.15
166.0 33.0
1.009 1.023
99.5 94.05
2
1.016 .0099 2
Dose Level: 0.75
51.0 44.0
1.013 1.026
47.5 4.95 2
1.020
.0092 2
Dosage Unit: mg/kg/day
6.5 7.0
6.8 .35 2
Dosage Unit : mg/kg/day
7.0 6.0
6.5 .71 2
Dosage Unit : mg/kg/day
6.0 6.0
6.0 .00 2
Covance 6329-223 3M Study No. T-6295.7
003411
APPENDIX 4
Individual Clinical Urinalysis Data
Males
Day 322
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS
ANIMAL NUMBER
U PRO MG/DL
U GLU
U KET U BILI U BLOOD UROBILI
Group : 1
105520 105526
Group : 3
105505 105523
Group : 4
105511 105522
Dose Level : 0
0 0-
Dose Level : 0.15
0_
0-
Dose Level: 0.75
0 0-
Dosage Unit: mg/kg/day
+++ _
--
Dosage Uni t: mg/kg/day
__
+++ -
Dosage Unit : mg/kg/day
_
++++
-
_
-
_
-
_
-
Covance 6329-223 3M Study No. T-6295.7
ANIMAL NUMBER
APPENDIX 4
Individual Clinical Urinalysis Data
Hales
Day 322
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOF.OOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-629S) IN CYNOMOLGUS
RBC
WBC
EPITH
BACT
CASTS CRYSTALS
PER HPF PER HPF PER HPF PER HPF PER LPF PER LPF1
URINE APP1
COMMENTS
Covance 6329-223 3M Study No. T- 6295.7
Group: 1 Dose Level: 0
Dosage Unit: mg/kg/day
105520
0
0
1
1
0
IB BJ _
105526
0
0
1
1
0
0
AJ Q
Group: 3 Dose Level: 0.15
Dosage Unit: mg/kg/day
105505
0
1
1
3
0
3B BJ
105523
0
0
1
3
0
2B BJ -
Group: 4 Dose Level: 0.75
Dosage Unit: mg/kg/day
105511
0
1
1
2
0
2B BJ Q
105522
0
0
0
2
0
0
BJ Q
003412
003413
APPENDIX 4
Individual Clinical Urinalysis Data
Females
Day 322
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-629S) IN CYNOMOLGUS
ANIMAL NUMBER
U VOL ML
SP GR
U PH
Group : 1
105529 IU5549
MEAN S.D. N
Group : 3
105539 105552
MEAN S.D. N
Group : 4
105533 105542
MEAN S.D. N
Dose Level : 0
87.0 354.0
1.010 1.003
220.5 188.80
2
1.006 .0050 2
Dose Level :: 0.15
76.0 42.0
1.015 1.021
59.0 24.04
2
1.018 .0042 2
Dose Level : 0.75
71.0 113.0
1.017 1.012
92.0 29.70
2
1.014 .0035 2
Dosage Unit : mg/kg'day
8.0 8.0
8.0 .00 2
Dosage Unit: mg/kg/day
7.0 6.0
6.5 .71 2
Dosage Unit: mg/kg/day
6.5 7.0
6.8 .35 2
Covance 6329-223 3M Study No. T-6295.7
003414
APPENDIX 4
Individual clinical Urinalysis Data
Females
Day 322
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS
ANIMAL NUMBER
U PRO MG/DL
U GLU
U KET U BILI U BLOOD UROBILI
Group: 1
105529 105549
Group : 3
105539 105552
Group : 4
105533 105542
Dose Level: 0
0 10
Dose Level: 0.15
0 0
Dose Level: 0.75
10 0
Dosage Unit:: mg/kg/day
++
Dosage Unit: mg/kg/day
++ +++++
-
Dosage Unit: mg/kg/day
++ ++
Covance 6329-223 3M Study No. T-6295.7
II
ANIMAL NUMBER
APPENDIX 4
Individual Clinical Urinalysis Data
Females
Day 322
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOP.OOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS
RBC
WBC
EPITH
BACT
CASTS CRYSTALS
PER HPF PER HPF PER HPF PER HPF PER LPF PER LPF1
URINE APPI
COMMENTS
Covance 6329-223 3M Study No. T-6295.7
Group : 1 Dose Level : n
Dosage Unit: mg/kg/day
105529
0
1
1
2
0
2B BJ -
105549
0
0
1
3
0
0
AJ -
Group : 3 Dose Level: 0.15
Dosage Unit: mg/kg/day
105539
0
1
1
3
0
ID BK
105552
0
0
i
3
0
IB CJ
Group: 4
105533 105542
Dose Level : 0.75
01 01
Dosage Unit: mg/kg/day
12 0 11 0
0 0
BO _
BJ -
003415
003416
APPENDIX 4
Individual Clinical Urinalysis Data
Males
Day 364
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS
ANIMAL NUMBER
U VOL ML
SP GR
U PH
Group : 1
105520 105526
MEAN S.D. H
Group : 3
105505 105523
MEAN S.D. N
Group: 4
105511 105522
MEAN S.D. N
Dose Level :: 0
149.0 264.0
1.019 1.015
206.5
81.32 2
1.017 .0028 2
Dose Level : 0.15
82.0 67.0
1.018 1.018
74.5 10.61
2
1.018 .0000
2
Dose Level : 0.75
100.0 80.0
1.015 1.022
90.0 14.14
2
1.018 .0050 2
Dosage Unit: mg/kg/day
8.0 7.5
7.8 .35 2
Dosage Unit: mg/kg/day
8.0 7.0
7.5 .71 2
Dosage Unit: mg/kg/day
7.5 6.0
6.8 1.06
2
Covance 6329-223 3M Study No. T-6295.7
003417
APPENDIX 4
Individual Clinical Urinalysis Data
Males
Day 364
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS
ANIMAL NUMBER
U PRO MG/DL
U GLU
U KET U BILI U BLOOD UROBILI
Group : 1
105520 105526
Group: 3
105505 105523
Group : 4
I0551I 105522
Dose Level : 0
10 ++++ 10 +
Dose Level: 0.15
0+ 10 -
Dose Level : 0.75
10 _ 10 +
Dosage Unit : mg/kg/day
+ -+
Dosage Unit : mg/kg/day
-+ ++ +++
Dosage Unit : mg/kg/day
_ ++ - +++
_
-
-
-
_ -
Covance 6329-223 3M Study No. T-6295.7
ANIMAL NUMBER
APPENDIX 4
Individual Clinical Urinalysis Data
Males
Day 364
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS
RBC
WBC
EPITH
BACT
CASTS CRYSTALS CRYSTALS
PER HPF PER HPF PER HPF PER HPF PER LPF PER LPF1 PER LPF2
URINE APP1
Covance 6329-223 3M Study No. T-6295.7
COMMENTS
Group : 1 Dose Level : 0
Dosage Unit: mg/kg/day
105520
0
1
1
3
0
3B1E
IK
BL
_
105526
0
1
3
0
3B1K
BL Q
Group : 3 Dose Level : 0.15
Dosage Unit: mg/kg/day
105505
0
0
1
2
0
3B3D
0
BL _
105523
0
1
1
3
0
3B3D
0
CK -
Group: 4
105511 105522
Dose Level : 0.75
00 00
Dosage Unit: mg/kg/day
03 0 130
4B3D 3B
0 0
BK _
BL -
003418
003419
APPENDIX 4
Individual clinical Urinalysis Data
Females
Day 364
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS
ANIMAL NUMBER
U VOL ML
SP GR
U PH
Group : i
105529 105549
MEAN S.D.
n
Group: 3
105539 105552
MEAN S.D. N
Group: 4
105533 105542
MEAN S.D. N
Dose Level:: 0
166.0 150.0
1.011 1.011
158.0 11.31 2
1.011 .0000 2
Dose Level:: 0.15
78.0 59.0
1.020 1.022
68.5 13.44
2
1.021 .0014 2
Dose Level: 0.75
43.0 109.0
1.018 1.019
76.0 46.67
2
1.018 .0007 2
Dosage Unit: mg/kg/day
8.0 8.0
8.0 .00 2
Dosage Unit: mg/kg/day
7.0 7.0
7.0 .00 2
Dosage Unit: mg/kg/day
6.5 7.5
7.0 .71 2
Covance 6329-223 3M Study No. T-6295.7
003420
APPENDIX 4
Individual Clinical Urinalysis Data
Females
Day 364
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS
ANIMAL HUMBER
U PRO MG/DL
U GLU
U KET U BILI U BLOOD UP.OBILI
Group: 1
105529 105549
Group: 3
105539 105552
Group: 4
105533 105542
Dose Level: 0
0 0 f
Dose Level: 0.15
10 10 +
Dose Level: 0.75
10 10 +
Dosage Unit: mg/kg/day
_+ "+
Dosage Unit: mg/kg/day
_
++ "
-M-+
Dosage Unit: mg/kg/day
_
+-
++ +
_
-
_
"
_ -
Covance 6329-223 3M Study No. T-6295.7
ANIMAL NUMBER
APPENDIX 4
Individual Clinical Urinalysis Data
Females
Day 364
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS
RBC
WBC
EPITH
BACT
CASTS CRYSTALS CRYSTALS
PER HPF PER HPF PER HPF PER HPF PER LPF PER LPF1 PER LPF2
URINE APP1
Covance 6329-223 3M Study No. T-6295.7
COMMENTS
Group: 1 Dore Level : 0
Dosage Unit: mg/kg/day
105529
U
0
0
3
0
4B2D
3K
BL
_
105549
f!
0
1
3
0
4B1D
0
BL -
Group : 3 Dore Level : 0.15
Dosage Unit: mg/kg/day
105539
0
1
3
0
4K 0
BK _
105552
li
0
1
3
0
3B1D
0
BL -
Group: 4 Dose Level : 0.75
Dosage Unit: mg/kg/day
105533
0
I
1
3
0
105542
0
0
0
3
0
2B 3B3K
0 0
BK _
BL -
003421
003422
APPENDIX 4
Individual Clinical Urinalysis Data
Males
Day 456
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS
ANIMAL NUMBER
U VOL ML
SP GR
U PH
Group : 1
105520 105526
MEAN S.D. N
Group: 3
105505 105523
MEAN S.D. N
Group: 4
105511 105522
MEAN S.D. N
Dose Level : 0
100.0 270.0
1.012 1.008
185.0 120.21
2
1.010 .0028 2
Dose Level : 0.15
286.0 78.0
1.004 1.011
182.0 147.08
2
1.008 .0050 2
Dose Level: 0.75
90.0 78.0
1.008 1.015
84.0 8.49 2
1.012 .0050 2
Dosage Unit: mg/kg/day
8.0 8.0
8.0 .00 2
Dosage Unit: mg/kg/day
8.0 8.0
8.0 .00 2
Dosage Unit: mg/kg/day
8.0 8.0
8.0 .00 2
Covance 6329-223 3M Study No. T-6295.7
003423
APPENDIX 4
Individual clinical Urinalysis Data
Males
Day 456
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS
ANIMAL NUMBER
U PRO MG/DL
U GLU
U KET U BILI U BLOOD UROBILI
Group: 1 Dose Level : 0
Dosage Unit: mg/kg/day
105520 105526
0 0
Group : 3 Dose Level: 0.15
Dosage Unit: mg/kg/day
105505 105523
0 10
Group: 4 Dose Level: 0.75
Dosage Unit: mg/kg/day
105511 105522
0 0
-
---
Covance 6329-223 3M Study No. T-6295.7
ANIMAL NUMBER
APPENDIX 4
Individual Clinical Urinalysis Data
Males
Day 456
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS
RBC
WBC
EPITH
BACT
CASTS CRYSTALS CRYSTALS
PER HPF PER HPF PER HPF PER HPF PER LPF PER LPF1 PER LPF2
URINE APPI
Covance 6329-223 3M Study No. T-6295.7
COMMENTS
Group : 1
105520 105526
Dose Level : 0
00 00
Dosage Unit: mg/kg/day
030 130
IBID 0
0 0
BK _
AJ -
J
Group: 3 Dor. Level : 0.15
Dosage Unit: mg/kg/day
105505
0
0
0
2
0
0
0
AJ 0
,
105523
0
0
0
3
0
4B1D
0
BK
Group: 4 Do:? Level : 0.75
Dosage Unit: mg/kg/day
105511
0
0
1
3
0
0
0
BJ Q
105522
0
0
0
3
0
2B4D
0
BJ
003424
003425
APPENDIX 4
Individual Clinical Urinalysis Data
Females
Day 456
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS
ANIMAL NUMBER
U VOL ML
SP GR
U PH
Group : 1
105529 105549
MEAN S.D. N
Group : 3
105539 105552
MEAN S.D. N
Group : 4
105533 105542
MEAN S.D. N
Dose Level : 0
98.0 330.0
1.013 1.005
214.0 164.05
2
1.009 .0057 2
Dose Level : 0.15
198.0 92.0
1.008 1.014
145.0 74.95 2
1.011 .0042 2
Dose Level : 0.75
60.0 176.0
1.002 1.008
118.0
82.02 2
1.005 .0042 2
Dosage Unit : mg/kg/day
8.0 8.0
8.0 .00 2
fLy
Dosage Unit: mg/kg/day
7.5 8.0
7.8 .35
2
Dosage unit : mg/kg/day
8.0 8.0
8.0 .00 2
Covance 6329-223 3M Study No. T-629S.7
003426
APPENDIX 4
Individual clinical Urinalysis Data
Females
Day 456
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS
ANIMAL NUMBER
U PRO MG./DL
U GLU
U KET U BILI U BLOOD UROBILI
Group : 1 Dose Level : 0
Dosage Unit: mg/kg/day
105529 105549
0 10
_
-
_
_
+++
Group : 3 Dose Level: 0.15
Dosage Unit: mg/kg/day
105539
0
_
_
105552
0
-
-
-
-
Group : 4
105533 105542
Dose Level : 0.75
0_
0-
_ -
Dosage Unit : mg/kg/day
_
-+
_
-
_
-
_
-
Covance 6329-223 3M Study No. T-6295.7
ANIMAL NUMBER
APPENDIX 4
Individual Clinical Urinalysis Data
Females
Day 456
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS
RBC
WBC
EPITH
BACT
CASTS CRYSTALS CRYSTALS
PER HPF PER HPF PER HPF PER HPF PER LPF PER LPFl PER LPF2
URINE APP'l
Covance 6329-223 3M Study No. T-6295.7
COMMENTS
Group: 1 Dose Level: 0
Dosage Unit: mg/kg/day
105529
0
0
1
3
0
105549
0
1
1
3
0
Group: 3 Dose Level: 0 .15
Dosage Unit: mg/kg/day
105539
0
i
1
3
0
105552
0
0
1
3
0
Group: 4 Dose Level: 0.75
Dosage Unit: mg/kg/day
105533
0
0
1
3
0
105542
0
0
0
3
0
2B4D 0
0 3B
2B 4B
0 0
0 0
0 0
BE _
AJ -
AJ _
BE -
AK _ AL -
003427
00342S
APPENDIX 4
Individual Clinical Urinalysis Data
Males
Day 546
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS
ANIMAL NUMBER
U VOL ML
SP GR
U PH
Group : 1
105520 105526
MEAN S.D. N
Group: 3
105505 105523
MEAN S.D. N
Group: 4
105511 105522
MEAN S.D. N
Dose Level: 0
480.0 380.0
1.005 1.005
430.0 70.71 2
1.005 .0000 2
Dose Level: 0.15
405.0 195.0
1.004 1.008
300.0 148.49
2
1.006 .0028 2
Dose Level: 0.75
345.0 100.0
1.005 1.015
222.5 173.24
2
1.010 .0071 2
Dosage
8.0 8.0
8.0 .00 2
Dosage
7.5 8.0
7.8 .35 2
Dosage
8.0 8.0
8.0 .00 2
mg/kg/day mg/kg/day mg/kg/day
Covance 6329-223 3M Study No. T-6295.7
003429
APPENDIX 4
Individual Clinical Urinalysis Data
Males
Day 546
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS
ANIMAL NUMBER
U PRO MG/DL
U GLU
U KET U BILI U BLOOD '
Group : 1
105520 105526
Group : 3
105505 105523
Group : 4
105511 105522
Dose Level : 0
0
Dose Level : 0.15
0 0
Dose Level : 0.75
0 0
Dosage Unit:: mg/kg/day --
Dosage Unit: mg/kg/day -
-
Dosage Unit: mg/kg/day --
Covance 6329-223 3M Study No. T-6295.7
ANIMAL NUMBER
APPENDIX 4
Individual Clinical Urinalysis Data
Males
Day 546
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS
RBC
WBC
EPITH
BACT
CASTS CRYSTALS CRYSTALS
PER HPF PER HPF PER HPF PER HPF PER LPF PER LPF1 PER LPF2
URINE APP1
Covance 6329-223 3M Study No. T-6295.7
COMMENTS
Group: 1
105520 105526
Dose Level: 0
0 00
Dosage Unit: mg/kg/day
1i0 030
IB IB
0 0
AJ _
AJ Q
Group: 3 Dose Level: 0.15
Dosage Unit: mg/kg/day
105505
0
0
0
2
0
0
0 AJ _
105523
0
0
0
1
0
2B 0
AJ Q
Group: 4 Dose Level: 0.75
Dosage Unit: mg/kg/day
105511
0
0
1
0
IB 0
AJ Q
105522
0
0
0
1
0
2B1D
2E
BK
003430
003431
APPENDIX 4
Individual Clinical Urinalysis Data
Females
Day 546
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-629S) IN CYNOMOLGUS
ANIMAL NUMBER
U VOL ML
SP GR
U PH
Group: i
105529 106549
MEAN S.D. N
Group: 3
105539 105552
MEAN S.D. N
Group : 4
105533 105542
MEAN S.D. N
Dose Level:: 0
105.0 160.0
1.015 1.007
132.5 38.89 2
1.011 .0057 2
Dose Level: 0.15
85.0 50.0
1.017 1.019
67.5 24.75
2
1.018 .0014 2
Dose Level : 0.75
42.0 156.0
1.017 1.010
99.0 80.61
2
1.014 .0050 2
Dosage Unit : mg/kg/day
8.0 8.0
8.0 .00 2
Dosage Unit : mg/kg/day
8.0 8.0
8.0 .00 2
Dosage Unit: mg/kg/day
8.0 8.0
8.0 .00 2
Covance 6329-223 3M Study No. T-6295.7
003432
APPENDIX 4
Individual Clinical Urinalysis Data
Females
Day 546
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS
ANIMAL NUMBER
U PRO MG/DL
U GLU
U KET U BILI U BLOOD UROBILI
Group : 1
105529 105549
Group: 3
105539 105552
Group : 4
105533 105542
Dose Level:: 0
0 0
Dose Level :; 0.15
10 10
Dose Level : 0.75
0 0
Dosage Unit : mg/kg/day "
-
Dosage Unit : mg/kg/day
--
Dosage unit : mg/kg/day -
+++
Covance 6329-223 3M Study No. T-629S.7
ANIMAL NUMBER
APPENDIX 4
Individual Clinical Urinalysis Data
Females
Day 546
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS
RBC
WBC
EPITH
BACT
CASTS CRYSTALS CRYSTALS
PER HPF PER HPF PER HPF PER HPF PER LPF PER LPF1 PER LPF2
URINE APP1
Covance 6329-223 3M Study No. T-6295.7
COMMENTS
Group: 1 Dose Level: 0
Dosage Unit: mg/kg/day
105529
0
1
0
2
0
2B2D
IF
BJ
_
105549
0
0
0
2
0
2B 0
BJ
Group: 3 Dose Level: 0.15
Dosage Unit: mg/kg/day
105539
0
0
u
2
0
3B1E
0
BK
105552
0
0
0
2
0
2B2E
0
BL -
Group: 4 Dose Level: 0.75
Dosage Unit: mg/kg/day
105533
0
0
0
2
0
3B3D
0
BL _
105542
0
1
1
1
0
3B 0
AL -
003433
APPENDIX 5
Covance 6329-223 3M T-6295.7
Individual Palmitoyl CoA Oxidase Determinations Individual Anatomic Pathology Data
685 0 0 3 4 3 4
003435
Appendix 5
Individual Palmitoyl CoA Oxidase Determinations
Terminal Sacrifice
Males
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
ANIMAL NUMBER
PCOAO IU/G
Group: 1
105508 105517 105519 105527
MEAN S.D. N
Group: 2
105514 105515 105516 105521
MEAN S.D. N
Group : 3
105510 105518 105524 105528
MEAN S.D. N
Dose Level
4 4 6 7
5 1.5 4
Dose Level
4 5 4 6
5 1.0 4
Dose Level
6 6 5 5
6 .6
4
Dosage Unit: mg/kg/day Dosage Unit: mg/kg/day Dosage Unit: mg/kg/day
686
Covance 6329-223 3M T-6295.7
Appendix 5
Individual Palmitoyl CoA Oxidase Determinations
Terminal Sacrifice
Hales
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
ANIMAL NUMBER
PCOAO IU/G
Group: 4
105507 105512
MEAN S.D. N
Dose Level: 0.75
8 6
7 1.4 2
Dosage Unit: mg/kg/day
Covance 6329-223 3M T-6295.7
003436
687
Appendix 5
Individual Palmitoyl CoA Oxidase Determinations
Terminal Sacrifice
Females
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
ANIMAL NUMBER
PCOAO IU/G
Group: 1
105530 105531 105535 105544
MEAN S.D. N
Group: 2
105537 105541 105547 105550
MEAN S.D. N
Group: 3
105532 105538 105545 105548
MEAN S.D. N
Dose Level: 0
3 4 4 5
4 .8
4
Dose Level
4 4 2 5
4 1.3 4
Dose Level: 0.15
5 5 6 7
6 1.0 4
Dosage Unit: mg/kg/day Dosage Unit: mg/kg/day Dosage Unit: mg/kg/day
Covance 6329-223 3M T-6295.7
003437
688
Appendix 5
Individual Palmitoyl CoA Oxidase Determinations
Terminal Sacrifice
Females
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T-6295) IN CYNOMOLGUS MONKEYS
ANIMAL NUMBER
PCOAO IU/G
Group: 4
105534 105536 105540 105551
MEAN S.D. N
Dose Level: 0.75
6 7 6 5
6 .8
4
Dosage Unit: mg/kg/day
Covance 6329-223 3M T-6295.7
003438
689
APPENDIX 5 Individual Anatomic Pathology Data
Unscheduled Deaths
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS
Covance 6329-223 3M T-6295.7
PAGE: 1
ANIMAL NUMBER: 105506
SEX: MALE
DOSE GROUP: 4
SACRIFICE STATUS: UNSCHEDULED (M)
DATE OF DEATH: 02/20/99
STUDY DAY OF DEATH: 179
STUDY WEEK OF DEATH: 26
TERMINAL BODY WEIGHT: 3625.0 GRAMS
DATE AND TIME OF NECROPSY: 02/20/99 12:40
PROSECTOR: DAVID SCHUETTE
RECORDER: NANCY DIEDRICH
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: ROBERT LEEDLE
WEIGHER: NANCY DIEDRICH
ORGAN NAME
ABSOLUTE ORGAN WEIGHT (GRAMS)
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%)
ORGAN TO BRAIN WEIGHT RATIO
ORGAN STATUS
LEFT ADRENAL (ADO) RIGHT ADRENAL (ADI)
BRAIN (BR) LF EPIDIDYMIS (EP0) RT EPIDIDYMIS (EP1) LF KIDNEY (KD0) RT KIDNEY (KD1)
LIVER (LI) LF TESTIS (TE0) RT TESTIS (TE1) PANCREAS (PA) LF THYROID/PARA (TTO) RT THYROID/PARA (TTl) GALLBLADDER (GB) BILE(VOLUME) (BI)
.4730 .3840 65.9350 1.2760 1.2520 6.1230 5.9240 88.6340 7.0730 7.0020
6.7010 .1980 .2070
.0130 % .0106 %
1.8189 % .0352 %
.0345 % .1689 .1634 %
2.4451 % .1951 % .1932 % .1849 .0055 % .0057 %
.0072 .0058 1.0000 .0194 .0190 .0929 .0898 1.3443 .1073 .1062 .1016 .0030 .0031
WEIGHT TAKEN WEIGHT TAKEN
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN NOT SCHEDULED NOT SCHEDULED
NECROPSY
OBSERVATIONS
HISTOPATHOLOGY
BONE, FEMUR (FE) : -GROWTH PLATE OPEN,-MODERATELY SEVERE
BRAIN (BR) :
-INFILTRATE, LYMPHOHISTIOCYTIC, PERIVASCULAR,-MINIMAL -INFILTRATE, MACROPHAGES, PIGMENTED, PERIVASCULAR,-MINIMAL -INFILTRATE, LYMPHOHISTIOCYTIC, MENINGEAL,-SLIGHT KIDNEY (KD) :
-INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL -CAST, PROTEINACEOUS,-SLIGHT
003439
690
APPENDIX 5 Individual Anatomic Pathology Data
Unscheduled Deaths
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT <PFOS;T-6295) IN CYNOMOLGUS MONKEYS
Covance 6329-223 3M T-6295.7
PAGE: 2
ANIMAL NUMBER: 105506
SEX: MALE
DOSE GROUP: 4
SACRIFICE STATUS: UNSCHEDULED (M)
DATE OF DEATH: 02/20/99
STUDY DAY OF DEATH:I: 179
STUDY WEEK OF DEATH: 26
TERMINAL BODY WEIGHT: 3625.0 GRAMS
DATE AND TIME OF NECROPSY: 02/20/99 12:40
PROSECTOR: DAVID SCHUETTE
RECORDER: NANCY DIEDRICH
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: ROBERT LEEDLE
WEIGHER: NANCY DIEDRICH
NECROPSY
O B S E R V A T I O N S (CONTINUED)
HISTOPATHOLOGY
LIVER (LI) :
-INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL, MULTI-FOCAL -HYPERTROPHY, HEPATOCELLULAR,-MODERATE, DIFFUSE -STASIS, BILE,-SLIGHT, MULTI-FOCAL THYMUS (TH) : -CYST,-PRESENT -ATROPHY,-MODERATELY SEVERE TRACHEA (TR) :
-INFILTRATE, LYMPHOHISTIOCYTIC, -MINIMAL ESOPHAGUS (ES) :
-INFILTRATE, LYMPHOHISTIOCYTIC,-SLIGHT THYROID (TY) :
-INFILTRATE, LYMPHOHISTIOCYTIC,-SLIGHT -CYST, ULTIMOBRANCHIAL,-PRESENT ADRENAL, CORTEX (AC) :
-MINERALIZATION, VASCULAR,-MINIMAL SALIV GL, MANDIB (SG) :
-INFILTRATE, LYMPHOHISTIOCYTIC,-SLIGHT SPINAL CORD (SC) :
-INFILTRATION, LYMPHOHISTIOCYTIC MENINGEAL/PERIVASCULAR,SLIGHT
DUODENUM (DU) : -INFILTRATE, MACROPHAGE, PIGMENTED,-MODERATE
JEJUNUM (JE) :
-INFILTRATE, MACROPHAGE, PIGMENTED,-SLIGHT ILEUM (IL) :
-INFILTRATE, MACROPHAGE, PIGMENTED,-SLIGHT URINARY BLADDER (UB) :
-INFILTRATE, LYMPHOHISTIOCYTIC,-SLIGHT
003440
691
APPENDIX 5 Individual Anatomic Pathology Data
Unscheduled Deaths
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS
Covance 6329-223 3M T-6295.7
PAGE: 3
ANIMAL NUMBER: 105506
SEX: MALE
DOSE GROUP: 4
SACRIFICE STATUS: UNSCHEDULED (M)
DATE OF DEATH: 02/20/99
STUDY DAY OF DEATH: 179
STUDY WEEK OF DEATH: 26
TERMINAL BODY WEIGHT: 3625.0 GRAMS
DATE AND TIME OF NECROPSY: 02/20/99 12:40
PROSECTOR: DAVID SCHUETTE
RECORDER: NANCY DIEDRICH
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: ROBERT LEEDLE
WEIGHER: NANCY DIEDRICH
NECROPSY
O B S E R V A T I O N S (CONTINUED)
HISTOPATHOLOGY
GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -EYES - DAVIDSONS -NO MACROSCOPIC LESIONS
CAUSE OF DEATH (CD) : -UNDETERMINED, -PRESENT
THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY:
BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BONE, STERNUM (SB), EYE (EY) , BRAIN (BR) , KIDNEY (KD) , LUNG (LU), HEART (HT) , LIVER (LI), GALLBLADDER (GB) , SPLEEN (SP) , THYMUS (TH) , LN, MESENTERIC (MS), TRACHEA (TR) , ESOPHAGUS (ES) , THYROID (TY) , PARATHYROID (PT) , ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , AORTA (AO), PITUITARY (PI), SALIV GL, MANDIB (SG) , MUSCLE, SKELETAL (SM) , SPINAL CORD (SC), NERVE, SCIATIC (SN) , STOMACH, GL (ST), DUODENUM (DU), PANCREAS (PA), JEJUNUM (JE) , ILEUM (IL) , CECUM (CE) , COLON (CO), RECTUM (RE), SKIN (SK), MAMMARY, MALE (MM), URINARY BLADDER (UB) , PROSTATE (PR), SEMINAL VESICLES (SV) , EPIDIDYMIDES (EP) , TESTIS (TE) , ADIPOSE TISSUE (AT) , LN, TRACHEOBRON (TB) , LN, ANT MES/PANC (AP)
THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION:
MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BONE, STERNUM (SB), EYE (EY) , LUNG (LU) , HEART (HT) , GALLBLADDER (GB) , SPLEEN (SP), LN, MESENTERIC (MS), PARATHYROID (PT) , ADRENAL, MEDULLA (MA) , AORTA (AO), PITUITARY (PI), MUSCLE, SKELETAL (SM) , NERVE, SCIATIC (SN) , STOMACH, GL (ST), PANCREAS (PA), CECUM (CE) , COLON (CO), RECTUM (RE), SKIN (SK), MAMMARY, MALE (MM), PROSTATE (PR), SEMINAL VESICLES (SV), EPIDIDYMIDES (EP), TESTIS (TE)
003441
692
APPENDIX 5 Individual Anatomie Pathology Data
Unscheduled Deaths
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS
Covance 6329-223 3M T-6295.7
PAGE: 4
ANIMAL NUMBER: 105509
SEX: MALE
DOSE GROUP: 4
SACRIFICE STATUS: UNSCHEDULED (D)
DATE OF DEATH: 01/27/99
STUDY DAY OF DEATH: 155
STUDY WEEK OF DEATH: 23
TERMINAL BODY WEIGHT: NOT ENTERED
DATE AND TIME OF NECROPSY: 01/27/99 10:21
PROSECTOR: NANCY DIEDRICH
RECORDER: MICHELE ZIMA
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: ROBERT LEEDLE
WEIGHER: NOT AVAILABLE
*** ORGAN WEIGHTS WERE NOT RECORDED ***
NECROPSY
OBSERVATIONS
HISTOPATHOLOGY
LUNG (LU) : -ADHESION(S) ; ALL LOBES TO EACH OTHER AND PLEURA: MULTIPLE INDISTINCT ADHESIONS; CANNOT DISTINGUISH LOBES FROM ONE ANOTHER; COLLECTED -MOTTLED; ALL RIGHT LOBES: RED, DARK RED, AND TAN; LOBES APPEAR FIRM -EROSION(S)/ULCERATION(S); APPEARS TO BE RIGHT CAUDAL LOBE: SINGLE ULCERATED AREA, 2.5 X 1.5 CM; ULCERATED AREA EXTENDS DEEP INTO LUNG TISSUE; WALLS OF ULCERATION APPEAR GREEN, TAN, GRAY AND MOIST; COLLECTED INTACT
LIVER (LI) : -MOTTLED; ALL LOBES: DARK BROWN AND TAN -LARGE; ALL LOBES: THICKENED
BONE, FEMUR (FE) : -GROWTH PLATE OPEN,-MODERATELY SEVERE
MARROW, FEMUR (FM) : >SECTION EXAMINED; TISSUE NOT PRESENT
KIDNEY (KD) : -MINERALIZATION, PAPILLARY,-MODERATE
LUNG (LU) : -FIBROSIS, PLEURAL/SUBPLEURAL, -MODERATE -INFILTRATE, MACROPHAGE, ALVEOLAR,-MODERATE -NECROSIS,-SEVERE -INFLAMMATION, ACUTE,-SEVERE -FIBRIN, PLEURAL,-MODERATELY SEVERE
LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR,-SLIGHT, DIFFUSE -VACUOLATION, HEPATOCELLULAR, CENTRILOBULAR,-MODERATE
THYMUS (TH) : -ATROPHY,-MODERATE
TRACHEA (TR) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL
SALIV GL, MANDIB (SG) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL
003442
693
APPENDIX 5 Individual Anatomic Pathology Data
Unscheduled Deaths
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS
Covance 6329-223 3M T-6295.7
PAGE: 5
ANIMAL NUMBER: 105509
SEX: MALE
DOSE GROUP: 4
SACRIFICE STATUS: UNSCHEDULED (D)
DATE OF DEATH: 01/27/99
STUDY DAY OF DEATH: 155
STUDY WEEK OF DEATH: 23
TERMINAL BODY WEIGHT: NOT ENTERED
DATE AND TIME OF NECROPSY: 01/27/99 10:21
PROSECTOR: NANCY DIEDRICH
RECORDER: MICHELE ZIMA
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: ROBERT LEEDLE
WEIGHER: NOT AVAILABLE
NECROPSY
O B S E R V A T I O N S (CONTINUED)
HISTOPATHOLOGY
COLON (CO) : -DARK FOCUS(I)/AREA(S); WITHIN MUCOSA: SINGLE DARK BROWN AREA, 0.3 X 0.2 CM; COLLECTED ON ROUTINE SECTION
LN, TRACHEOBRON (TB) : -LARGE; UP TO 1.0 X 0.9 X 0.5 CM (CAP 29)
JEJUNUM (JE) : -INFILTRATE, MACROPHAGE, PIGMENTED,-MODERATE
ILEUM (IL) : -INFILTRATE, MACROPHAGE, PIGMENTED,-SLIGHT
COLON (CO) : >UNREMARKABLE
CAUSE OF DEATH (CD) : -NECROSIS, PULMONARY,-PRESENT
LN, TRACHEOBRON (TB) : -INFLAMMATION, ACUTE,-MODERATE
003443
694
APPENDIX 5 Individual Anatomic Pathology Data
Unscheduled Deaths
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS
Covance 6329-223 3M T-6295.7
PAGE: 6
ANIMAL NUMBER: 105509
SEX: MALE
DOSE GROUP: 4
SACRIFICE STATUS: UNSCHEDULED (D)
DATE OF DEATH: 01/27/99
STUDY DAY OF DEATH: 155
STUDY WEEK OF DEATH: 23
TERMINAL BODY WEIGHT: NOT ENTERED
DATE AND TIME OF NECROPSY: 01/27/99 10:21
PROSECTOR: NANCY DIEDRICH
RECORDER: MICHELE ZIMA
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: ROBERT LEEDLE
WEIGHER: NOT AVAILABLE
THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BONE, STERNUM (SB) , EYE (EY) , BRAIN (BR) , KIDNEY (KD) , HEART (HT) , GALLBLADDER (GB) , SPLEEN (SP) , THYMUS (TH) , LN, MESENTERIC (MS) , TRACHEA (TR) , ESOPHAGUS (ES) , THYROID (TY) , PARATHYROID (PT) , ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , AORTA (AO), PITUITARY (PI), SALIV GL, MANDIB (SG), MUSCLE, SKELETAL (SM), SPINAL CORD (SC), NERVE, SCIATIC (SN), STOMACH, GL (ST), DUODENUM (DU) , PANCREAS (PA) , JEJUNUM (JE) , ILEUM (IL) , CECUM (CE) , RECTUM (RE) , SKIN (SK) , MAMMARY, MALE (MM) , URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESICLES (SV), EPIDIDYMIDES (EP), TESTIS (TE), ADIPOSE TISSUE (AT), GENERAL COMMENT (GC) , LN, ANT MES/PANC (AP)
THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: MARROW, STERNUM (SE) , BONE, STERNUM (SB), EYE (EY) , BRAIN (BR) , HEART (HT) , GALLBLADDER (GB) , SPLEEN (SP) , LN, MESENTERIC (MS), ESOPHAGUS (ES) , THYROID (TY) , PARATHYROID (PT) , ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , AORTA (AO), PITUITARY (PI), MUSCLE, SKELETAL (SM) , SPINAL CORD (SC), NERVE, SCIATIC (SN) , STOMACH, GL (ST), DUODENUM (DU), PANCREAS (PA), CECUM (CE) , RECTUM (RE), SKIN (SK) , MAMMARY, MALE (MM), URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESICLES (SV) , EPIDIDYMIDES (EP), TESTIS (TE)
003444
695
APPENDIX 5 Individual Anatomie Pathology Data
Terminal Sacrifice
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS
Covance 6329-223 3M T-6295.7
PAGE: 1
ANIMAL NUMBER: 105508
SEX: MALE
DOSE GROUP: 1
SACRIFICE STATUS: SCHEDULED, TERMINAL JSACRIFICE
DATE OF DEATH: 02/25/99
STUDY DAY OF DEATH:: 184
STUDY WEEK OF DEATH: 27
TERMINAL BODY WEIGHT : 3285 .0 GRAMS
DATE AND TIME OF NECROPSY: 02/25/99 10:24
PROSECTOR:: KEVIN BILLINGS
RECORDER:: MICHELE ZIMA
POST--FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: ROBERT LEEDLE
WEIGHER: MICHELE ZIMA
ORGAN NAME
ABSOLUTE ORGAN WEIGHT (GRAMS)
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%)
ORGAN TO BRAIN WEIGHT RATIO
ORGAN STATUS
LEFT ADRENAL (ADO) RIGHT ADRENAL (ADI) BRAIN (BR) LF EPIDIDYMIS (EP0) RT EPIDIDYMIS (EP1) LF KIDNEY (KD0) RT KIDNEY (KD1) LIVER (LI) LF TESTIS (TE0) RT TESTIS (TE1) PANCREAS (PA) LF THYROID/PARA (TT0) RT THYROID/PARA (TT1) GALLBLADDER (GB)
BILE(VOLUME) (BI)
.2650 .2010 62.3670 .8310 1.0370 5.8660 5.4930 59.3880 5.5360 5.1190 4.3000 .1520 .1390 .4890 1.6000 mL
.0081 % .0061 % 1.8985 % .0253 %
.0316 % .1786 .1672 1.8079 % .1685 % .1558 % .1309 % .0046 % .0042 %
.0042 .0032 1.0000 .0133 .0166 .0941 .0881 .9522 .0888 .0821 .0689 .0024 .0022
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
NECROPSY
OBSERVATIONS
HISTOPATHOLOGY
LUNG (LU) : -RED FOCUS (I)/AREA(S) ; ALL LOBES: MULTIPLE DARK RED PINPOINT
FOCI
BONE, FEMUR (FE) : -GROWTH PLATE OPEN,-MODERATELY SEVERE
KIDNEY (KD) :
-INFILTRATE, LYMPHOHISTIOCYTIC,-SLIGHT -GLOMERULOSCLEROSIS,-MINIMAL LUNG (LU) : -HYPERPLASIA, LYMPHOCYTIC, PERIBRONCHIOLAR/PERIVASCULAR,-
SLIGHT LIVER (LI) :
-INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL, MULTI-FOCAL
003445
696
APPENDIX 5 Individual Anatomic Pathology Data
Terminal Sacrifice
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS
Covance 6329-223 3M T-6295.7
PAGE: 2
ANIMAL NUMBER: 105508
SEX: MALE
DOSE GROUP: 1
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 02/25/99
STUDY DAY OF DEATH: 184
STUDY WEEK OF DEATH: 27
TERMINAL BODY WEIGHT: 3285.0 GRAMS
DATE AND TIME OF NECROPSY: 02/25/99 10:24
PROSECTOR: KEVIN BILLINGS
RECORDER: MICHELE ZIMA
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: ROBERT LEEDLE
WEIGHER: MICHELE ZIMA
NECROPSY
O B S E R V A T I O N S (CONTINUED)
HISTOPATHOLOGY
SPLEEN (SP) : -LARGE; 7.0 X 4.0 X 3.0 CM
GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -EYES - DAVIDSONS
SPLEEN (SP) : UNREMARKABLE
LN, MESENTERIC (MS) : -HEMORRHAGE,-SLIGHT
TRACHEA (TR) :
-INFILTRATE, LYMPHOHISTIOCYTIC,-SLIGHT SALIV GL, MANDIB (SG) :
-INFILTRATE, LYMPHOHISTIOCYTIC,-SLIGHT COLON (CO) :
-INFILTRATE, EOSINOPHILIC,-SLIGHT MAMMARY, MALE (MM) :
SECTION EXAMINED; TISSUE NOT PRESENT PROSTATE (PR) :
-INFLAMMATION, LYMPHOHISTIOCYTIC, -MINIMAL
003446
697
APPENDIX 5 Individual Anatomie Pathology Data
Terminal Sacrifice
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS
Covanee 6329-223 3M T-6295.7
PAGE: 3
ANIMAL NUMBER: 105508
SEX: MALE
DOSE GROUP: 1
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 02/25/99
STUDY DAY OF DEATH: 184
STUDY WEEK OF DEATH: 27
TERMINAL BODY WEIGHT: 3285.0 GRAMS
DATE AND TIME OF NECROPSY: 02/25/99 10:24
PROSECTOR: KEVIN BILLINGS
RECORDER: MICHELE ZIMA
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: ROBERT LEEDLE
WEIGHER: MICHELE ZIMA
THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BONE, STERNUM (SB), EYE (EY) , BRAIN (BR) , KIDNEY (KD) , HEART (HT) , LIVER (LI), GALLBLADDER (GB) , THYMUS (TH) , LN, MESENTERIC (MS), TRACHEA (TR) , ESOPHAGUS (ES) , THYROID (TY) , PARATHYROID (PT) , ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , AORTA (AO), PITUITARY (PI), SALIV GL, MANDIB (SG) , MUSCLE, SKELETAL (SM) , SPINAL CORD (SC), NERVE, SCIATIC (SN) , STOMACH, GL (ST), DUODENUM (DU), PANCREAS (PA), JEJUNUM (JE) , ILEUM (IL) , CECUM (CE) , COLON (CO), RECTUM (RE), SKIN (SK) , MAMMARY, MALE (MM), URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESICLES (SV), EPIDIDYMIDES (EP), TESTIS (TE), ADIPOSE TISSUE (AT), LN, TRACHEOBRON (TB), LN, ANT MES/PANC (AP)
THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BONE, STERNUM (SB) , EYE (EY) , BRAIN (BR) , HEART (HT) , GALLBLADDER (GB) ,
THYMUS (TH). ESOPHAGUS (ES) , THYROID (TY) , PARATHYROID (PT) , ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , AORTA (AO), PITUITARY (PI), MUSCLE, SKELETAL (SM) , SPINAL CORD (SC), NERVE, SCIATIC (SN) , STOMACH, GL (ST), DUODENUM (DU) , PANCREAS (PA) , JEJUNUM (JE) , ILEUM (IL) , CECUM (CE) , RECTUM (RE) , SKIN (SK) , URINARY BLADDER (UB) , SEMINAL VESICLES (SV), EPIDIDYMIDES (EP), TESTIS (TE)
003447
698
APPENDIX 5 Individual Anatomic Pathology Data
Terminal Sacrifice
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS
Covance 6329-223 3M T-6295.7
PAGE: 4
ANIMAL NUMBER: 105517
SEX: MALE
DOSE GROUP: 1
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 02/25/99
STUDY DAY OF DEATH: 184
STUDY WEEK OF DEATH: 27
TERMINAL BODY WEIGHT: 3055.0 GRAMS
DATE AND TIME OF NECROPSY: 02/25/99 8:11
PROSECTOR: KEVIN BILLINGS
RECORDER: MICHELE ZIMA
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: ROBERT LEEDLE
WEIGHER: MICHELE ZIMA
ORGAN NAME
ABSOLUTE ORGAN WEIGHT (GRAMS)
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%)
ORGAN TO BRAIN WEIGHT RATIO
ORGAN STATUS
LEFT ADRENAL (ADO) RIGHT ADRENAL (ADI)
BRAIN (BR) LF EPIDIDYMIS (EP0) RT EPIDIDYMIS (EPl) LF KIDNEY (KD0) RT KIDNEY (KD1) LIVER (LI) LF TESTIS (TE0) RT TESTIS (TE1) PANCREAS (PA) LF THYROID/PARA (TT0) RT THYROID/PARA (TT1) GALLBLADDER (GB) BILE(VOLUME) (BI)
.2840 .1430 62.4920 1.0930 1.2250 5.9980 5.7530 44.2710 8.0310 8.1690 5.8790 .1490 .1400 .6330 1.6000 mL
.0093 % .0047 %
2.0456 % .0358 % .0401 % .1963 % .1883 %
1.4491 % .2629 % .2674 % .1924 % .0049 .0046 %
.0045 .0023 1.0000 .0175 .0196 .0960 .0921 .7084 .1285 .1307 .0941 .0024 .0022
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
NECROPSY
OBSERVATIONS
HISTOPATHOLOGY
BONE, FEMUR (FE) : -GROWTH PLATE OPEN,-MODERATE
MARROW, FEMUR (FM) :
SECTION EXAMINED; TISSUE NOT PRESENT LUNG (LU) :
-HYPERPLASIA, LYMPHOCYTIC, PERIBRONCHIOLAR/PERIVASCULAR, MINIMAL
LIVER (LI) :
-INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL, MULTI-FOCAL
003448
699
APPENDIX 5 Individual Anatomic Pathology Data
Terminal Sacrifice
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS
Covance 6329-223 3M T-6295.7
PAGE: 5
ANIMAL NUMBER: 105517
SEX: MALE
DOSE GROUP: 1
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 02/25/99
STUDY DAY OF DEATH: 184
STUDY WEEK OF DEATH: 27
TERMINAL BODY WEIGHT: 3055.0 GRAMS
DATE AND TIME OF NECROPSY: 02/25/99 8:11
PROSECTOR: KEVIN BILLINGS
RECORDER: MICHELE ZIMA
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: ROBERT LEEDLE
WEIGHER: MICHELE ZIMA
NECROPSY
O B S E R V A T I O N S (CONTINUED)
HISTOPATHOLOGY
GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -EYES - DAVIDSONS -NO MACROSCOPIC LESIONS
LN, MESENTERIC (MS) : -INFILTRATE, MACROPHAGE, PIGMENTED,-MODERATE
TRACHEA (TR) :
-INFILTRATE, LYMPHOHISTIOCYTIC,-SLIGHT ADRENAL, CORTEX (AC) :
-HYPERTROPHY, CORTICAL CELL,-MINIMAL SALIV GL, MANDIB (SG) :
-INFILTRATE, LYMPHOHISTIOCYTIC, -MINIMAL PANCREAS (PA) :
-INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL COLON (CO) :
-PARASITISM, INTRAMUSCULAR, -PRESENT
003449
700
APPENDIX 5 Individual Anatomic Pathology Data
Terminal Sacrifice
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS
Covance 6329-223 3M T-6295.7
PAGE: 6
ANIMAL NUMBER: 105517
SEX: MALE
DOSE GROUP: 1
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 02/25/99
STUDY DAY OF DEATH:1: 184
STUDY WEEK OF DEATH: 27
TERMINAL BODY WEIGHT: 3055.0 GRAMS
DATE AND TIME OF NECROPSY: 02/25/99 8:11
PROSECTOR: KEVIN BILLINGS
RECORDER: MICHELE ZIMA
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: ROBERT LEEDLE
WEIGHER: MICHELE ZIMA
THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BONE, STERNUM (SB) , EYE (EY) , BRAIN (BR) , KIDNEY (KD) , LUNG (LU), HEART (HT) , LIVER (LI), GALLBLADDER (GB) , SPLEEN (SP) , THYMUS (TH) , LN, MESENTERIC (MS), TRACHEA (TR) , ESOPHAGUS (ES), THYROID (TY) , PARATHYROID (PT) , ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , AORTA (AO), PITUITARY (PI), SALIV GL, MANDIB (SG), MUSCLE, SKELETAL (SM), SPINAL CORD (SC), NERVE, SCIATIC (SN), STOMACH, GL (ST), DUODENUM (DU), PANCREAS (PA), JEJUNUM (JE) , ILEUM (IL) , CECUM (CE) , COLON (CO), RECTUM (RE), SKIN (SK), MAMMARY, MALE (MM), URINARY BLADDER (UB) , PROSTATE (PR), SEMINAL VESICLES (SV) , EPIDIDYMIDES (EP) , TESTIS (TE) , ADIPOSE TISSUE (AT) , LN, TRACHEOBRON (TB) , LN, ANT MES/PANC (AP)
THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: MARROW, STERNUM (SE) , BONE, STERNUM (SB), EYE (EY) , BRAIN (BR) , KIDNEY (KD) , HEART (HT) , GALLBLADDER (GB) , SPLEEN (SP), THYMUS (TH), ESOPHAGUS (ES), THYROID (TY) , PARATHYROID (PT), ADRENAL, MEDULLA (MA) , AORTA (AO), PITUITARY (PI), MUSCLE, SKELETAL (SM) , SPINAL CORD (SC), NERVE, SCIATIC (SN) , STOMACH, GL (ST), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL) , CECUM (CE) , RECTUM (RE), SKIN (SK) , MAMMARY, MALE (MM), URINARY BLADDER (UB) , PROSTATE (PR), SEMINAL VESICLES (SV), EPIDIDYMIDES (EP), TESTIS (TE)
003450
701
APPENDIX 5 Individual Anatomic Pathology Data
Terminal Sacrifice
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS
Covance 6329-223 3M T-6295.7
PAGE: 7
ANIMAL NUMBER: 105519
SEX: MALE
DOSE GROUP: 1
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 02/25/99
STUDY DAY OF DEATH: 184
STUDY WEEK OF DEATH: 27
TERMINAL BODY WEIGHT: 3140.0 GRAMS
DATE AND TIME OF NECROPSY: 02/25/99 6:57
PROSECTOR: STEVE VAN ADESTINE
RECORDER: TODD ACKER
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: ROBERT LEEDLE
WEIGHER: TODD ACKER
ORGAN NAME
ABSOLUTE ORGAN WEIGHT (GRAMS)
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%)
ORGAN TO BRAIN WEIGHT RATIO
ORGAN STATUS
LEFT ADRENAL (ADO) RIGHT ADRENAL (ADI) BRAIN (BR) LF EPIDIDYMIS (EPO) RT EPIDIDYMIS (EP1) LF KIDNEY (KDO) RT KIDNEY (KDl) LIVER (LI) LF TESTIS (TEO) RT TESTIS (TE1) PANCREAS (PA) LF THYROID/PARA (TTO) RT THYROID/PARA (TT1) GALLBLADDER (GB) BILE(VOLUME) (BI)
.2820 .2330 62.8980
.7730 .8270 5.5490 5.3860 53.1740
2.7780 2.9990 5.5570
.1310 .1220
.7260 1.2000 mL
.0090 % .0074 % 2.0031 % .0246 % .0263 t .1767 % .1715 % 1.6934 % .0885 % .0955 % .1770 % .0042 t
.0039 %
.0045 .0037 1.0000 .0123 .0131 .0882 .0856 .8454 .0442 .0477 .0883 .0021 .0019
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
NECROPSY
OBSERVATIONS
HISTOPATHOLOGY
BONE, FEMUR (FE) : -GROWTH PLATE OPEN,-MODERATELY SEVERE
MARROW, FEMUR (FM) :
SECTION EXAMINED; TISSUE NOT PRESENT BRAIN (BR) :
-INFILTRATE, MACROPHAGES, PIGMENTED, PERIVASCULAR,-MINIMAL KIDNEY (KD) :
-INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL
003451
702
APPENDIX 5 Individual Anatomic Pathology Data
Terminal Sacrifice
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS
Covance 6329-223 3M T-6295.7
PAGE: 8
ANIMAL NUMBER: 105519
SEX: MALE
DOSE GROUP: 1
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 02/25/99
STUDY DAY OF DEATH: 184
STUDY WEEK OF DEATH: 27
TERMINAL BODY WEIGHT: 3140.0 GRAMS
DATE AND TIME OF NECROPSY: 02/25/99 6:57
PROSECTOR: STEVE VAN ADESTINE
RECORDER: TODD ACKER
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: ROBERT LEEDLE
WEIGHER: TODD ACKER
NECROPSY
O B S E R V A T I O N S (CONTINUED)
HISTOPATHOLOGY
LUNG (LU) :
-HYPERPLASIA, LYMPHOCYTIC, PERIBRONCHIOLAR/PERIVASCULAR,SLIGHT
LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC, -MINIMAL, MULTI-FOCAL
GALLBLADDER (GB) :
-INFILTRATE, LYMPHOHISTIOCYTIC, -MINIMAL TRACHEA (TR) :
-INFILTRATE, LYMPHOHISTIOCYTIC, -SLIGHT PARATHYROID (PT) :
-CYST,-PRESENT ADRENAL, CORTEX (AC) :
-INFILTRATE, LYMPHOHISTIOCYTIC, -MINIMAL SALIV GL, MANDIB (SG) :
-INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL JEJUNUM (JE) :
-INFILTRATE, MACROPHAGE, PIGMENTED,-MODERATE ILEUM (IL) :
-INFILTRATE, MACROPHAGE, PIGMENTED,-MODERATE CECUM (CE) :
-INFILTRATE, MACROPHAGE, PIGMENTED,-MODERATE MAMMARY, MALE (MM) :
>SECTION EXAMINED; TISSUE NOT PRESENT PROSTATE (PR) :
-INFLAMMATION, LYMPHOHISTIOCYTIC,-MINIMAL EPIDIDYMIDES <EP) :
-HYPOSPERMIA,-MODERATE TESTIS (TE) :
-IMMATURE,-PRESENT
003452
703
APPENDIX 5 Individual Anatomic Pathology Data
Terminal Sacrifice
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLU0R00CTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS
Covance 6329-223 3M T-6295.7
PAGE: 9
ANIMAL NUMBER: 105519
SEX: MALE
DOSE GROUP: 1
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 02/25/99
STUDY DAY OF DEATH: 184
STUDY WEEK OF DEATH; 27
TERMINAL BODY WEIGHT: 3140.0 GRAMS
DATE AND TIME OF NECROPSY: 02/25/99 6:57
PROSECTOR: STEVE VAN ADESTINE
RECORDER: TODD ACKER
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: ROBERT LEEDLE
WEIGHER: TODD ACKER
NECROPSY
O B S E R V A T I O N S (CONTINUED)
HISTOPATHOLOGY
GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -EYES - DAVIDSONS -NO MACROSCOPIC LESIONS
THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BONE, STERNUM (SB), EYE (EY) , BRAIN (BR) , KIDNEY (KD) ,
LUNG (LU), HEART (HT) , LIVER (LI), GALLBLADDER (GB) , SPLEEN (SP) , THYMUS (TH) , LN, MESENTERIC (MS), TRACHEA (TR) , ESOPHAGUS (ES) , THYROID (TY) , PARATHYROID (PT) , ADRENAL, CORTEX (AC) , ADRENAL, MEDULLA (MA) , AORTA (AO) , PITUITARY (PI), SALIV GL, MANDIB (SG) , MUSCLE, SKELETAL (SM) , SPINAL CORD (SC), NERVE, SCIATIC (SN) ,
STOMACH, GL (ST), DUODENUM (DU), PANCREAS (PA), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), SKIN (SK), MAMMARY, MALE (MM), URINARY BLADDER (UB) , PROSTATE (PR), SEMINAL VESICLES (SV) , EPIDIDYMIDES (EP) , TESTIS (TE) , ADIPOSE TISSUE (AT) , LN, TRACHEOBRON (TB) , LN, ANT MES/PANC (AP)
THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: MARROW, STERNUM (SE) , BONE, STERNUM (SB), EYE (EY) , HEART (HT) , SPLEEN (SP) , THYMUS (TH) , LN, MESENTERIC (MS), ESOPHAGUS (ES), THYROID (TY) , ADRENAL, MEDULLA (MA) , AORTA (AO), PITUITARY (PI), MUSCLE, SKELETAL (SM) , SPINAL CORD (SC), NERVE, SCIATIC (SN) , STOMACH, GL (ST), DUODENUM (DU), PANCREAS (PA), COLON (CO), RECTUM (RE), SKIN (SK) , URINARY BLADDER (UB) , SEMINAL VESICLES (SV)
003453
704
APPENDIX 5 Individual Anatomic Pathology Data
Terminal Sacrifice
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS
Covance 6329-223 3M T-6295.7
PAGE: 10
ANIMAL NUMBER: 105527
SEX: MALE
DOSE GROUP: 1
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 02/25/99
STUDY DAY OF DEATH: 184
STUDY WEEK OF DEATH: 27
TERMINAL BODY WEIGHT: 4680.0 GRAMS
DATE AND TIME OF NECROPSY: 02/25/99 11:00
PROSECTOR: KEVIN BILLINGS
RECORDER: MICHELE ZIMA
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: ROBERT LEEDLE
WEIGHER: MICHELE ZIMA
ORGAN NAME
LEFT ADRENAL (ADO) RIGHT ADRENAL (ADI) BRAIN (BR) LF EPIDIDYMIS (EP0) RT EPIDIDYMIS (EP1) LF KIDNEY (KD0) RT KIDNEY (KD1) LIVER (LI) LF TESTIS (TE0) RT TESTIS (TE1) PANCREAS (PA) LF THYROID/PARA (TT0) RT THYROID/PARA (TT1) GALLBLADDER (GB) BILE(VOLUME) (BI)
ABSOLUTE ORGAN WEIGHT (GRAMS)
.3120 .2600 64.8130 1.8660 1.7750 7.5090 7.3890 62.8470 11.5730 10.6940 6.0920 .2380 .2750 .6430 2.4000 mL
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%)
.0067 % .0056 % 1.3849 % .0399 % .0379 % .1604 % .1579 % 1.3429 % .2473 % .2285 % .1302 % .0051 % .0059 %
ORGAN TO BRAIN WEIGHT RATIO
.0048 .0040 1.0000 .0288 .0274 .1159 .1140 .9697 .1786 .1650 .0940 .0037 .0042
ORGAN STATUS
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
NECROPSY
OBSERVATIONS
HISTOPATHOLOGY
BONE, FEMUR (FE) : -GROWTH PLATE OPEN,-SLIGHT
MARROW, FEMUR (FM) : SECTION EXAMINED; TISSUE NOT PRESENT
BRAIN (BR) :
-INFILTRATE, MACROPHAGES, PIGMENTED, PERIVASCULAR,-MINIMAL LUNG (LU) :
-HYPERPLASIA, LYMPHOCYTIC, PERIBRONCHIOLAR/PERIVASCULAR,SLIGHT
003454
705
APPENDIX 5 Individual Anatomic Pathology Data
Terminal Sacrifice
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS
Covance 6329-223 3M T-6295.7
PAGE: 11
ANIMAL NUMBER: 105527
SEX: MALE
DOSE GROUP: 1
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 02/25/99
STUDY DAY OF DEATH: 184
STUDY WEEK OF DEATH: 27
TERMINAL BODY WEIGHT: 4680.0 GRAMS
DATE AND TIME OF NECROPSY: 02/25/99 11:00
PROSECTOR: KEVIN BILLINGS
RECORDER: MICHELE ZIMA
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: ROBERT LEEDLE
WEIGHER: MICHELE ZIMA
NECROPSY
O B S E R V A T I O N S (CONTINUED)
HISTOPATHOLOGY
SKIN (SK) : -ABRASION(S)/ULCERATION(S); 2.0 CM FROM TIP OF TAIL: SINGLE RED, MOIST ABRADED AREA, 0.8 CM IN DIAMETER; COLLECTED
GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -EYES - DAVIDSONS
LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL, MULTI-FOCAL -GRANULOMA,-MINIMAL, FOCAL
THYMUS (TH) : -ATROPHY,-SEVERE
SALIV GL, MANDIB (SG) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL
MUSCLE, SKELETAL (SM) : -INFILTRATE, LYMPHOHISTIOCYTIC, -MINIMAL
DUODENUM (DU) :
-INFILTRATE, MACROPHAGE, PIGMENTED,-SLIGHT ILEUM (IL) :
-INFILTRATE, MACROPHAGE, PIGMENTED,-MODERATE SKIN (SK) :
-HYPERPLASIA, EPIDERMAL (ACANTHOSIS),-MODERATE -INFLAMMATION, CHRONIC-ACTIVE,-SLIGHT -ULCERATION, -MODERATELY SEVERE URINARY BLADDER (UB) :
-INFILTRATE, LYMPHOHISTIOCYTIC, -MINIMAL
003455
706
APPENDIX 5 Individual Anatomic Pathology Data
Terminal Sacrifice
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS
Covance 6329-223 3M T-6295.7
PAGE: 12
ANIMAL NUMBER: 105527
SEX: MALE
DOSE GROUP: 1
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 02/25/99
STUDY DAY OF DEATH: 184
STUDY WEEK OF DEATH: 27
TERMINAL BODY WEIGHT: 4680.0 GRAMS
DATE AND TIME OF NECROPSY: 02/25/99 11:00
PROSECTOR: KEVIN BILLINGS
RECORDER: MICHELE ZIMA
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: ROBERT LEEDLE
WEIGHER: MICHELE ZIMA
THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BONE, STERNUM (SB), EYE (EY) , BRAIN (BR) , KIDNEY (KD) , LUNG (LU), HEART (HT), LIVER (LI), GALLBLADDER (GB), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), TRACHEA (TR), ESOPHAGUS (ES), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), SALIV GL, MANDIB (SG) , MUSCLE, SKELETAL (SM) , SPINAL CORD (SC), NERVE, SCIATIC (SN) , STOMACH, GL (ST), DUODENUM (DU), PANCREAS (PA), JEJUNUM (JE) , ILEUM (IL) , CECUM (CE) , COLON (CO), RECTUM (RE), MAMMARY, MALE (MM), URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESICLES (SV), EPIDIDYMIDES (EP) , TESTIS (TE), ADIPOSE TISSUE (AT), LN, TRACHEOBRON (TB) , LN, ANT MES/PANC (AP)
THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: MARROW, STERNUM (SE) , BONE, STERNUM (SB), EYE (EY) , KIDNEY (KD) , HEART (HT) , GALLBLADDER (GB) , SPLEEN (SP) , LN, MESENTERIC (MS), TRACHEA (TR) , ESOPHAGUS (ES) , THYROID (TY) , PARATHYROID (PT) , ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , AORTA (AO), PITUITARY (PI), SPINAL CORD (SC), NERVE, SCIATIC (SN) , STOMACH, GL (ST), PANCREAS (PA), JEJUNUM (JE) , CECUM (CE) , COLON (CO), RECTUM (RE), MAMMARY, MALE (MM), PROSTATE (PR), SEMINAL VESICLES (SV), EPIDIDYMIDES (EP), TESTIS (TE)
003456
707
APPENDIX 5 Individual Anatomic Pathology Data
Terminal Sacrifice
Covance 6329-223 3M T-6295.7
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS
ANIMAL NUMBER: 105514
SEX: MALE
DOSE GROUP: 2
SACRIFICE STATUS: SCHEDULED, TERMINAL 1SACRIFICE
DATE OF DEATH: 02/25/99
STUDY DAY OF DEATH : 184
STUDY WEEK OF DEATH: 27
TERMINAL BODY WEIGHT : 3495..0 GRAMS
DATE AND TIME OF NECROPSY: 02/25/99 9:21
PROSECTOR: KEVIN BILLINGS
RECORDER: MICHELE ZIMA
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST : ROBERT LEEDLE
WEIGHER: MICHELE ZIMA
ORGAN NAME
ABSOLUTE ORGAN WEIGHT (GRAMS)
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%)
ORGAN TO BRAIN WEIGHT RATIO
ORGAN STATUS
LEFT ADRENAL (ADO) RIGHT ADRENAL (ADI) BRAIN (BR) LF EPIDIDYMIS (EP0) RT EPIDIDYMIS (EP1) LF KIDNEY (KD0) RT KIDNEY (KD1)
LIVER (LI) LF TESTIS (TE0) RT TESTIS (TE1) PANCREAS (PA) LF THYROID/PARA (TT0) RT THYROID/PARA (TT1)
.3620 .2420 62.4280 1.1580 1.0010 6.0230 6.1700
64.2170 6.7090 5.1600 4.7970
.3130 .3200
.0104 % .0069 % 1.7862 %
.0331 % .0286 % .1723 % .1765 %
1.8374 % .1920 % .1476 % .1373 %
.0090 % .0092 %
.0058 .0039 1.0000
.0185 .0160 .0965 .0988
1.0287 .1075 .0827 .0768
.0050 .0051
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
NECROPSY
OBSERVATIONS
HISTOPATHOLOGY
LUNG (LU) : -ADHESION (S) ; ALL LOBES TO EACH OTHER, PLEURA, PERICARDIAL SAC, AND CAUDAL LOBES TO DIAPHRAGM: MULTIPLE RED, TAN, FIBROUS ADHESIONS; COLLECTED INTACT
GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -EYES - DAVIDSONS
LUNG (LU) : >NOT REQUIRED TO BE EXAMINED FOR ANIMAL
LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL, MULTI-FOCAL
THYMUS (TH) : -ATROPHY,-MODERATE
003457
APPENDIX 5 Individual Anatomic Pathology Data
Terminal Sacrifice
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS.-T-6295) IN CYNOMOLGUS MONKEYS
Covance 6329-223 3M T-6295.7
PAGE: 14
ANIMAL NUMBER: 105514
SEX: MALE
DOSE GROUP: 2
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 02/25/99
STUDY DAY OF DEATH: 184
STUDY WEEK OF DEATH: 27
TERMINAL BODY WEIGHT: 3495.0 GRAMS
DATE AND TIME OF NECROPSY: 02/25/99 9:21
PROSECTOR: KEVIN BILLINGS
RECORDER: MICHELE 2IMA
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: ROBERT LEEDLE
WEIGHER: MICHELE ZIMA
NECROPSY
O B S E R V A T I O N S (CONTINUED)
HISTOPATHOLOGY
GENERAL INFORMATION (XX) : >NOTE :>GALLBLADDER WEIGHT IS 0.7220 GRAMS BILE VOLUME IS 1.4000 ML
THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BONE, STERNUM (SB), EYE (EY) , BRAIN (BR) , KIDNEY (KD) , HEART (HT) , LIVER (LI), GALLBLADDER (GB) , SPLEEN (SP) , THYMUS (TH) , LN, MESENTERIC (MS), TRACHEA (TR) , ESOPHAGUS (ES), THYROID (TY) , PARATHYROID (PT) , ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , AORTA (AO), PITUITARY (PI), SALIV GL, MANDIB (SG), MUSCLE, SKELETAL (SM) , SPINAL CORD (SC), NERVE, SCIATIC (SN) , STOMACH, GL (ST), DUODENUM (DU), PANCREAS (PA), JEJUNUM (JE) , ILEUM (IL) , CECUM (CE) , COLON (CO), RECTUM (RE), SKIN (SK) , MAMMARY, MALE (MM), URINARY BLADDER (UB) , PROSTATE (PR), SEMINAL VESICLES (SV) , EPIDIDYMIDES (EP) , TESTIS (TE) , ADIPOSE TISSUE (AT), LN, TRACHEOBRON (TB) , LN, ANT MES/PANC (AP)
003458
APPENDIX 5 Individual Anatomic Pathology Data
Terminal sacrifice
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS.-T-6295) IN CYNOMOLGUS MONKEYS
Covance 6329-223 3M T-6295.7
PAGE: IS
ANIMAL NUMBER: 105515
SEX: MALE
DOSE GROUP: 2
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 02/26/99
STUDY DAY OF DEATH:: 185
STUDY WEEK OF DEATH: 27
TERMINAL BODY WEIGHT: 3475.,0 GRAMS
DATE AND TIME OF NECROPSY: 02/26/99 6: 45
PROSECTOR: STEVE VAN ADESTINE
RECORDER:: JOHN S.. HALFORD
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: ROBERT LEEDLE
WEIGHER: JOHN S. HALFORD
ORGAN NAME
ABSOLUTE ORGAN WEIGHT (GRAMS)
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%)
ORGAN TO BRAIN WEIGHT RATIO
ORGAN STATUS
LEFT ADRENAL (ADO) RIGHT ADRENAL (ADI) BRAIN (BR)
LF EPIDIDYMIS (EPO) RT EPIDIDYMIS (EP1) LF KIDNEY (KDO) RT KIDNEY (KD1) LIVER (LI) LF TESTIS (TEO) RT TESTIS (TE1) PANCREAS (PA)
LF THYRO ID/PARA (TTO )
RT THYROID/PARA (TT1)
.2770 .1900 63.7670 .7590 .8690 6.4220 6.2010 55.8260 2.7190 3.3300 5.0260 .1340
.1240
.0080 % .0055 % 1.8350 % .0218 % .0250 % .1848 % .1784 % 1.6065 % .0782 % .0958 % .1446 % .0039
.0036 %
.0043 .0030 1.0000
.0119 .0136 .1007 .0972 .8755 .0426 .0522 .0788
.0021
.0019
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
WEIGHT TAKEN
NECROPSY
OB SERVA T ION S
HISTOPATHOLOGY
GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -EYES - DAVIDSONS -NO MACROSCOPIC LESIONS
GENERAL INFORMATION (XX) : >NOTE:GALLBLADDER WEIGHT IS 0.4620 GRAMS BILE VOLUME IS 1.2000 ML
LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL, MULTI--FOCAL
003459
APPENDIX 5 Individual Anatomic Pathology Data
Terminal Sacrifice
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT lPFOS;T-6295) IN CYNOMOLGUS MONKEYS
Covance 6329-223 3M T-6295.7
PAGE: 16
ANIMAL NUMBER: 105515
SEX: MALE
DOSE GROUP: 2
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 02/26/99
STUDY DAY OF DEATH: 185
STUDY WEEK OF DEATH: 27
TERMINAL BODY WEIGHT: 3475.0 GRAMS
DATE AND TIME OF NECROPSY: 02/26/99 6:45
PROSECTOR: STEVE VAN ADESTINE
RECORDER: JOHN S. HALFORD
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: ROBERT LEEDLE
WEIGHER: JOHN S. HALFORD
THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BONE, STERNUM (SB), EYE (EY) , BRAIN (BR) , KIDNEY (KD) , LUNG (LU), HEART (HT) , LIVER (LI), GALLBLADDER (GB) , SPLEEN (SP) , THYMUS (THI , LN, MESENTERIC (MS), TRACHEA (TR) , ESOPHAGUS (ES) , THYROID (TY) , PARATHYROID (PT) , ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , AORTA (AO), PITUITARY (PI), SALIV GL, MANDIB (SG), MUSCLE, SKELETAL (SM) , SPINAL CORD (SC), NERVE, SCIATIC (SN) , STOMACH, GL (ST), DUODENUM (DU), PANCREAS (PA), JEJUNUM (JE) , ILEUM (IL) , CECUM (CE) , COLON (CO), RECTUM (RE), SKIN (SK), MAMMARY, MALE (MM), URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESICLES (SV), EPIDIDYMIDES (EP), TESTIS (TE), ADIPOSE TISSUE (AT), LN, TRACHEOBRON (TB) , LN, ANT MES/PANC (AP)
THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: THYMUS (TH)
003460
APPENDIX 5 Individual Anatomie Pathology Data
Terminal Sacrifice
Covance 6329-223 3M T-6295.7
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS
ANIMAL NUMBER: 105516
SEX: MALE
DOSE GROUP: 2
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 02/26/99
STUDY DAY OF DEATH:: 185
STUDY WEEK OF DEATH: 27
TERMINAL BODY WEIGHT : 3170..0 GRAMS
DATE AND TIME OF NECROPSY: 02/26/99 7:15
PROSECTOR: KEVIN BILLINGS
RECORDER: MICHELE ZIMA
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: ROBERT LEEDLE
WEIGHER: MICHELE ZIMA
ORGAN NAME
ABSOLUTE ORGAN WEIGHT (GRAMS)
ORGAN WEIGHT RELATIVE TO BODY WEIGHT 1%)
ORGAN TO BRAIN WEIGHT RATIO
ORGAN STATUS
LEFT ADRENAL (ADO) RIGHT ADRENAL (ADI) BRAIN (BR) LF EPIDIDYMIS (EP0) RT EPIDIDYMIS (EP1) LF KIDNEY (KDO) RT KIDNEY (KD1) LIVER (LI) LF TESTIS (TE0)
RT TESTIS (TE1) PANCREAS (PA) LF THYROID/PARA ITT0) RT THYROID/PARA (TT1 )
.2940 .2410 67.0240
.8820 .7570 6.8380 7.0240 68.1040 3.3570 5.1290 3.0500 .2040 .1430
.0093 % .0076 % 2.1143 % .0278 % .0239 % .2157 % .2216 % 2.1484
.1059 % .1618 % .0962 % .0064 % .0045 %
.0044 .0036 1.0000
.0132 .0113 .1020 .1048 1.0161
.0501 .0765 .0455 .0030 .0021
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
NECROPSY
O B S E R V A T I I 5N S
HISTOPATHOLOGY
SPLEEN (SP) : -LARGE; 7.0 X 5.0 X 3.0 CM
TESTIS (TE) : -LARGE; RIGHT: 2.5 X 1.5 X 1.4 CM (FOR COMPARISON, LEFT IS 2.0 X 1.5 X 1.0 CM)
GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -EYES - DAVIDSONS
SPLEEN (SP) : >NOT REQUIRED TO BE EXAMINED FOR ANIMAL
THYMUS <TH) : -CYST,-PRESENT
TESTIS (TE) : >NOT REQUIRED TO BE EXAMINED FOR ANIMAL
003461
APPENDIX 5 Individual Anatomic Pathology Data
Terminal Sacrifice
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS
Covance 6329-223 3M T-629S.7
PAGE: 18
ANIMAL NUMBER: 105516
SEX: MALE
DOSE GROUP: 2
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 02/26/99
STUDY DAY OF DEATH: 185
STUDY WEEK OF DEATH: 27
TERMINAL BODY WEIGHT: 3170.0 GRAMS
DATE AND TIME OF NECROPSY: 02/26/99 7:15
PROSECTOR: KEVIN BILLINGS
RECORDER: MICHELE ZIMA
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: ROBERT LEEDLE
WEIGHER: MICHELE ZIMA
NECROPSY
O B S E R V A T I O N S (CONTINUED)
HISTOPATHOLOGY
GENERAL INFORMATION (XX) : >NOTE:^GALLBLADDER WEIGHT IS 0.6300 GRAMS BILE VOLUME IS 1.4000 ML
THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BONE, STERNUM (SB), EYE (EY) , BRAIN (BR) , KIDNEY (KD) , LUNG (LU), HEART (HT) , LIVER (LI), GALLBLADDER (GB) , THYMUS (TH) , LN, MESENTERIC (MS), TRACHEA (TR) , ESOPHAGUS (ES), THYROID (TY) , PARATHYROID (PT) , ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , AORTA (AO), PITUITARY (PI), SALIV GL, MANDIB (SG), MUSCLE, SKELETAL (SM) , SPINAL CORD (SC), NERVE, SCIATIC (SN), STOMACH, GL (ST), DUODENUM (DU), PANCREAS (PA), JEJUNUM (JE) , ILEUM (ID, CECUM (CE) , COLON (CO), RECTUM (RE), SKIN (SK), MAMMARY, MALE (MM), URINARY BLADDER (UB) , PROSTATE (PR), SEMINAL VESICLES (SV) , EPIDIDYMIDES (EP) , ADIPOSE TISSUE (AT) , LN, TRACHEOBRON (TB) , LN, ANT MES/PANC (AP)
THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: LIVER (LI)
003462
APPENDIX 5 Individual Anatomie Pathology Data
Terminal Sacrifice
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295 ) IN CYNOMOLGUS MONKEYS
Covance 6329-223 3M T-6295.7
PAGE: 19
ANIMAL NUMBER: 105521
SEX: MALE
DOSE GROUP: 2
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 02/26/99
STUDY DAY OF DEATH: 185
STUDY WEEK OF DEATH: 27
TERMINAL BODY WEIGHT: 4385.0 GRAMS
DATE AND TIME OF NECROPSY: 02/26/99 10:48
PROSECTOR: KEVIN BILLINGS
RECORDER: MICHELE ZIMA
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: ROBERT LEEDLE
WEIGHER: MICHELE ZIMA
ORGAN NAME
ABSOLUTE ORGAN WEIGHT (GRAMS)
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%)
ORGAN TO BRAIN WEIGHT RATIO
ORGAN STATUS
LEFT ADRENAL (ADO) RIGHT ADRENAL (ADI) BRAIN (BR) LF EPIDIDYMIS (EP0) RT EPIDIDYMIS (EP1) LF KIDNEY (KD0) RT KIDNEY (KD1) LIVER (LI) LF TESTIS (TEO) RT TESTIS (TE1) PANCREAS (PA)
LF THYROID/PARA (TT0) RT THYROID/PARA (TT1)
.3090 .2230 53.9580 2.8840 2.7980 7.1230 7.6030 60.2000 18.7540 18.8730 6.3800 .4490 .4660
.0070 % .0051 % 1.2305 %
.0658 % .0638 .1624 % .1734 % 1.3729 % .4277 % .4304 % .1455 % .0102 % .0106 %
.0057 .0041 1.0000
.0534 .0519 .1320 .1409 1.1157 .3476 .3498 .1182 .0083 .0086
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
NECROPSY
OBSERVATIONS
HISTOPATHOLOGY
GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -EYES - DAVIDSONS -NO MACROSCOPIC LESIONS .
LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL, MULTI-FOCAL -VACUOLATION, HEPATOCELLULAR,-MINIMAL, MULTI-FOCAL -STASIS, BILE,-MODERATE, MULTI-FOCAL
THYMUS (TH) :
-ATROPHY,-MODERATELY SEVERE
003463
APPENDIX 5 Individual Anatomic Pathology Data
Terminal sacrifice
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS
Covance 6329-223 3M T-6295.7
PAGE: 20
ANIMAL NUMBER: 105521
SEX: MALE
DOSE GROUP: 2
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 02/26/99
STUDY DAY OF DEATH: 185
STUDY WEEK OF DEATH: 27
TERMINAL BODY WEIGHT: 4385.0 GRAMS
DATE AND TIME OF NECROPSY: 02/26/99 10:48
PROSECTOR: KEVIN BILLINGS
RECORDER: MICHELE ZIMA
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: ROBERT LEEDLE
WEIGHER: MICHELE ZIMA
NECROPSY
O B S E R V A T I O N S (CONTINUED)
HISTOPATHOLOGY
GENERAL INFORMATION (XX) :
>NOTE:GALLBLADDER WEIGHT IS 0.4810 GRAMS BILE VOLUME IS 1.4000 ML
THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BONE, STERNUM (SB), EYE (EY) , BRAIN (BR) , KIDNEY (KD) , LUNG (LU) , HEART (HT) , LIVER (LI), GALLBLADDER (GB) , SPLEEN (SP) , THYMUS (TH) , LN, MESENTERIC (MS), TRACHEA (TR) , ESOPHAGUS (ES), THYROID (TY) , PARATHYROID (PT) , ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , AORTA (AO), PITUITARY (PI), SALIV GL, MANDIB (SG), MUSCLE, SKELETAL (SM), SPINAL CORD (SC), NERVE, SCIATIC (SN),
STOMACH, GL (ST), DUODENUM (DU), PANCREAS (PA), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), SKIN (SK) , MAMMARY, MALE (MM), URINARY BLADDER (UB) , PROSTATE (PR), SEMINAL VESICLES (SV) , EPIDIDYMIDES (EP) , TESTIS (TE) , ADIPOSE TISSUE (AT), LN, TRACHEOBRON (TB) , LN, ANT MES/PANC (AP)
003464
APPENDIX 5 Individual Anatomic Pathology Data
Terminal Sacrifice
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS
Covance 6329-223 3M T-6295.7
PAGE: 21
ANIMAL NUMBER: I0S510
SEX: MALE
DOSE GROUP: 3
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 02/26/99
STUDY DAY OF DEATH: 185
STUDY WEEK OF DEATH: 27
TERMINAL BODY WEIGHT: 3180.0 GRAMS
DATE AND TIME OF NECROPSY: 02/26/99 9:48
PROSECTOR: KEVIN BILLINGS
RECORDER: MICHELE 2IMA
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: ROBERT LEEDLE
WEIGHER: MICHELE ZIMA
ORGAN NAME
ABSOLUTE ORGAN WEIGHT (GRAMS)
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%)
ORGAN TO BRAIN WEIGHT RATIO
ORGAN STATUS
LEFT ADRENAL (ADO) RIGHT ADRENAL (ADI) BRAIN (BR)
LF EPIDIDYMIS (EP0) RT EPIDIDYMIS (EP1) LF KIDNEY (KD0) RT KIDNEY (KD1) LIVER (LI) LP TESTIS <TE0) RT TESTIS (TE1) PANCREAS (PA) LF THYROID/PARA (TT0) RT THYROID/PARA (TT1)
.2490 .1600 56.7600 1.0910 1.0750 6.4950 6.1190
54.2060 6.0950 5.8860 3.8800 .1660 .1960
.0078 % .0050 %
1.7849 % .0343 % .0338 .2042 .1924 %
1.7046 % .1917 % .1851 % .1220 % .0052 % .0062 %
.0044 .0028 1.0000 .0192 .0189
.1144 .1078
.9550 .1074 .1037 .0684 .0029 .0035
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
NECROPSY
OBSERVATIONS
HISTOPATHOLOGY
LUNG (LU) : -ADHESION (S) ; BILATERAL CAUDAL LOBES TO PLEURA AND
DIAPHRAGM: MULTIPLE TAN, FIBROUS ADHESIONS; COLLECTED INTACT ADIPOSE TISSUE (AT) :
-RAISED FOCUS(I)/AREA(S); DIFFUSE, THROUGHOUT MESENTERY AND THORACIC CAVITY: MULTIPLE, TAN, FIRM NODULES, UP TO 0.6 CM IN DIAMETER WITHIN MESENTERY (CAP 29), UP TO 0.3 CM IN DIAMETER WITHIN THORACIC CAVITY (CAP 30) AND COLLECTED INTACT WITH LUNG ADHESIONS GENERAL COMMENT (GC) :
-BONE MARROW SMEAR TAKEN -EYES - DAVIDSONS
LUNG (LU) : >NOT REQUIRED TO BE EXAMINED FOR ANIMAL
ADIPOSE TISSUE (AT) : >NOT REQUIRED TO BE EXAMINED FOR ANIMAL
003465
APPENDIX 5 Individual Anatomic Pathology Data
Terminal Sacrifice
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS
Covance 6329-223 3M T-6295.7
PAGE: 22
ANIMAL NUMBER: 105510
SEX: MALE
DOSE GROUP: 3
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 02/26/99
STUDY DAY OF DEATH: 185
STUDY WEEK OF DEATH: 27
TERMINAL BODY WEIGHT: 3180.0 GRAMS
DATE AND TIME OF NECROPSY: 02/26/99 9:48
PROSECTOR: KEVIN BILLINGS
RECORDER: MICHELE ZIMA
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: ROBERT LEEDLE
WEIGHER: MICHELE ZIMA
NECROPSY
O B S E R V A T I O N S (CONTINUEDI
HISTOPATHOLOGY
GENERAL INFORMATION (XX) :
>NOTE:GALLBLADDER WEIGHT IS 0.6690 GRAMS BILE VOLUME IS 2.4000 ML
THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BONE, STERNUM (SB), EYE (EY) , BRAIN (BR) , KIDNEY (KD) , HEART (HT), LIVER (LI), GALLBLADDER 1GB), SPLEEN (SP), THYMUS !TH), LN, MESENTERIC (MS), TRACHEA (TR) , ESOPHAGUS (ES), THYROID <TY) , PARATHYROID (PT) , ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , AORTA (AO), PITUITARY (PI), SALIV GL, MANDIB (SG) , MUSCLE, SKELETAL (SM) , SPINAL CORD (SC), NERVE, SCIATIC (SN) , STOMACH, GL (ST), DUODENUM (DU), PANCREAS (PA), JEJUNUM (JE) , ILEUM (IL), CECUM (CE) , COLON (CO), RECTUM (RE), SKIN (SK), MAMMARY, MALE (MM), URINARY BLADDER (UB) , PROSTATE (PR), SEMINAL VESICLES (SV) , EPIDIDYMIDES (EP) , TESTIS (TE) , LN, TRACHEOBRON (TB) , LN, ANT MES/PANC (AP)
THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: LIVER (LI), THYMUS (TH)
003466
APPENDIX 5 Individual Anatomic Pathology Data
Terminal Sacrifice
26-WEEX CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS
Covance 6329-223 3M T-6295.7
PAGE: 23
ANIMAL NUMBER: 105518
SEX: MALE
DOSE GROUP: 3
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 02/26/99
STUDY DAY OF DEATH: 185
STUDY WEEK OF DEATH: 27
TERMINAL BODY WEIGHT: 3070.0 GRAMS
DATE AND TIME OF NECROPSY: 02/26/99 9:20
PROSECTOR: KEVIN BILLINGS
RECORDER: MICHELE ZIMA
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: ROBERT LEEDLE
WEIGHER: MICHELE ZIMA
ORGAN NAME
ABSOLUTE ORGAN WEIGHT (GRAMS)
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%)
ORGAN TO BRAIN WEIGHT RATIO
ORGAN STATUS
LEFT ADRENAL (ADO) RIGHT ADRENAL (ADI) BRAIN (BR) LF EPIDIDYMIS (EP0) RT EPIDIDYMIS (EP1) LF KIDNEY (KD0) RT KIDNEY (KD1) LIVER (LI) LF TESTIS (TE0) RT TESTIS (TE1) PANCREAS (PA)
LF THYROID/PARA (TT0) RT THYROID/PARA (TT1)
.2790 .2460 62.8420 .8790 1.0970 5.6790 5.6110 57.5930 4.5720 4.6220 3.1580 .2450 .3110
.0091 % .0080 % 2.0470 % .0286 % .0357 % .1850 % .1828 %
1.8760 % .1489 % .1506 % .1029 %
.0080 % .0101 %
.0044 .0039 1.0000 .0140
.0175 .0904 .0893 .9165 .0728 .0735 .0503 .0039 .0049
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
WEIGHT TAKEN WEIGHT TAKEN
NECROPSY
OBSERVATIONS
HISTOPATHOLOGY
GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -EYES - DAVIDSONS
-NO MACROSCOPIC LESIONS
GENERAL INFORMATION (XX) : >NOTE :>GALLBLADDER WEIGHT IS 0.5320 GRAMS BILE VOLUME IS 1.3000 ML
THYMUS (TH) : -ATROPHY,-MINIMAL
003467
APPENDIX 5 Individual Anatomic Pathology Data
Terminal Sacrifice
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS
Covance 6329-223 3M T-6295.7
PAGE: 24
ANIMAL NUMBER: 105518
SEX: MALE
DOSE GROUP: 3
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 02/26/99
STUDY DAY OF DEATH: 185
STUDY WEEK OF DEATH: 27
TERMINAL BODY WEIGHT: 3070.0 GRAMS
DATE AND TIME OF NECROPSY: 02/26/99 9:20
PROSECTOR: KEVIN BILLINGS
RECORDER: MICHELE 2IMA
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: ROBERT LEEDLE
WEIGHER: MICHELE ZIMA
THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BONE, STERNUM (SB), EYE (EY) , BRAIN (BR) , KIDNEY (KD) , LUNG (LU), HEART (HT) , LIVER (LI), GALLBLADDER (GB) , SPLEEN (SP) , THYMUS (TH) , LN, MESENTERIC (MS), TRACHEA (TR) , ESOPHAGUS (ES), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), SALIV GL, MANDIB (SG), MUSCLE, SKELETAL (SM), SPINAL CORD (SC), NERVE, SCIATIC (SN>, STOMACH, GL (ST), DUODENUM (DU) , PANCREAS (PA), JEJUNUM (JE) , ILEUM (IL) , CECUM (CE) , COLON (CO), RECTUM (RE),
SKIN (SK), MAMMARY, MALE (MM), URINARY BLADDER (UB) , PROSTATE (PR), SEMINAL VESICLES (SV) , EPIDIDYMIDES (EP) , TESTIS (TE) , ADIPOSE TISSUE (AT), LN, TRACHEOBRON (TB) , LN, ANT MES/PANC (AP)
THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: LIVER (LI)
I.
o
CO
>
C)
05
APPENDIX 5 Individual Anatomic Pathology Data
Terminal Sacrifice
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLU0R00CTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS
Covance 6329-223 3M T-6295.7
PAGE: 25
ANIMAL NUMBER: 105524
SEX: MALE
DOSE GROUP: 3
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 02/26/99
STUDY DAY OF DEATH: 185
STUDY WEEK OF DEATH: 27
TERMINAL BODY WEIGHT: 3035.0 GRAMS
DATE AND TIME OF NECROPSY: 02/26/99 7:42
PROSECTOR: STEVE VAN ADESTINE
RECORDER: JOHN S. HALFORD
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: ROBERT LEEDLE
WEIGHER: JOHN S. HALFORD
ORGAN NAME
ABSOLUTE ORGAN WEIGHT (GRAMS)
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%)
ORGAN TO BRAIN WEIGHT RATIO
ORGAN STATUS
LEFT ADRENAL (ADO) RIGHT ADRENAL (ADI) BRAIN (BR) LF EPIDIDYMIS (EP0)' RT EPIDIDYMIS (EP1) LF KIDNEY (KD0) RT KIDNEY (KD1) LIVER (LI)
LF TESTIS (TE0)
RT TESTIS (TE1) PANCREAS (PA)
LF THYROID/PARA (TT0) RT THYROID/PARA (TT1)
.2420 .1860 63.9330 .9350 .9840 5.0370 4.8440
52.5550
4.6940 4.2750 4.6550
.1210 .1330
.0080 % .0061 % 2.1065 % .0308 % .0324 % .1660 % .1596 % 1.7316 %
.1547 %
.1409 % .1534 % .0040 %
.0044 %
.0038 .0029 1.0000 .0146 .0154 .0788 .0758
.8220
.0734 .0669 .0728 .0019 .0021
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
WEIGHT TAKEN
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
NECROPSY
OBSERVATIONS
HISTOPATHOLOGY
GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -EYES - DAVIDSONS -NO MACROSCOPIC LESIONS
GENERAL INFORMATION (XX) : >NOTE :>GALLBLADDER WEIGHT IS 0.9610 GRAMS BILE VOLUME IS 0.8000 ML
THYMUS (TH) : -ATROPHY,-MINIMAL
003469
APPENDIX 5 Individual Anatomic Pathology Data
Terminal Sacrifice
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS.-T-6295 ) IN CYNOMOLGUS MONKEYS
Covance 6329-223 3M T-6295.7
PAGE: 26
ANIMAL NUMBER: 105524
SEX: MALE
DOSE GROUP: 3
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 02/26/99
STUDY DAY OF DEATH: 185
STUDY WEEK OF DEATH: 27
TERMINAL BODY WEIGHT: 3035.0 GRAMS
DATE AND TIME OF NECROPSY: 02/26/99 7:42
PROSECTOR: STEVE VAN ADESTINE
RECORDER: JOHN S. HALFORD
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: ROBERT LEEDLE
WEIGHER: JOHN S. HALFORD
THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR IFE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY) , BRAIN (BR) , KIDNEY (KD) , LUNG (LU), HEART (HT) , LIVER (LI), GALLBLADDER (GB) , SPLEEN (SP) , THYMUS (TH) , LN, MESENTERIC (MS), TRACHEA (TR) , ESOPHAGUS (ES), THYROID (TY) , PARATHYROID (PT) , ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , AORTA (AO), PITUITARY (PI), SALIV GL, MANDIB (SG) , MUSCLE, SKELETAL (SM) , SPINAL CORD (SC), NERVE, SCIATIC (SN), STOMACH, GL (ST), DUODENUM (DU), PANCREAS (PA), JEJUNUM (JE) , ILEUM (IL) , CECUM (CE) , COLON (CO), RECTUM (RE),
SKIN (SK), MAMMARY, MALE (MM), URINARY BLADDER (UB) , PROSTATE (PR), SEMINAL VESICLES (SV) , EPIDIDYMIDES (EP) , TESTIS (TE>, ADIPOSE TISSUE (AT), LN, TRACHEOBRON (TB), LN, ANT MES/PANC (AP)
THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: LIVER (LI)
003470
APPENDIX 5 Individual Anatomie Pathology Data
Terminal Sacrifice
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS
Covance 6329-223 3M T-6295.7
PAGE: 27
ANIMAL NUMBER: 105528
SEX: MALE
DOSE GROUP: 3
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 02/26/99
STUDY DAY OF DEATH: 185
STUDY WEEK OF DEATH: 27
TERMINAL BODY WEIGHT: 3475.0 GRAMS
DATE AND TIME OF NECROPSY: 02/26/99 10:19
PROSECTOR: KEVIN BILLINGS
RECORDER: MICHELE ZIMA
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: ROBERT LEEDLE
WEIGHER: MICHELE ZIMA
ORGAN NAME
ABSOLUTE ORGAN WEIGHT (GRAMS)
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%)
ORGAN TO BRAIN WEIGHT RATIO
ORGAN STATUS
LEFT ADRENAL (ADO) RIGHT ADRENAL (ADI) BRAIN (BR)
LF EPIDIDYMIS (EP0) RT EPIDIDYMIS (EP1) LF KIDNEY (KD0) RT KIDNEY (KD1) LIVER (LI) LF TESTIS (TE0) RT TESTIS (TE1) PANCREAS (PA)
LF THYROID/PARA (TTO) RT THYROID/PARA (TT1)
.3070 .2620 69.8730 .9990 .9290 6.3390 6.3690 64.9760 5.0300 5.2350
5.8230
.2980 .3900
.0088 % .0075 % 2.0107 % .0287 % .0267 % .1824 % .1833 % 1.8698 % .1447 % .1506 %
.1676 %
.0086 %
.0112 %
.0044 .0037 1.0000 .0143 .0133 .0907 .0912 .9299 .0720 .0749
.0833
.0043 .0056
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
WEIGHT TAKEN
WEIGHT TAKEN WEIGHT TAKEN
NECROPSY
OBSERVATIONS
HISTOPATHOLOGY
GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -EYES - DAVIDSONS -NO MACROSCOPIC LESIONS
GENERAL INFORMATION (XX) : >NOTE:GALLBLADDER WEIGHT IS 0.5220 GRAMS BILE VOLUME IS 1.8000 ML
LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL, MULTI-FOCAL -HYPERTROPHY, HEPATOCELLULAR,-SLIGHT, DIFFUSE
THYMUS (TO) : -ATROPHY,-SLIGHT
003471
APPENDIX 5 Individual Anatomic Pathology Data
Terminal Sacrifice
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS
Covance 6329-223 3M T-6295.7
PAGE: 28
ANIMAL NUMBER: 105528
SEX: MALE
DOSE GROUP: 3
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 02/26/99
STUDY DAY OF DEATH:I: 185
STUDY WEEK OF DEATH: 27
TERMINAL BODY WEIGHT: 3475.0 GRAMS
DATE AND TIME OF NECROPSY: 02/26/99 10:19
PROSECTOR: KEVIN BILLINGS
RECORDER: MICHELE ZIMA
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: ROBERT LEEDLE
WEIGHER: MICHELE ZIMA
THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE. FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BONE, STERNUM (SB), EYE (EY) , BRAIN (BR) , KIDNEY (KD) , LUNG (LU) , HEART (HT) , LIVER (LI), GALLBLADDER (GB) , SPLEEN (SP) , THYMUS (TH) , LN, MESENTERIC (MS), TRACHEA (TR) , ESOPHAGUS (ES), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), SALIV GL, MANDIB (SG) , MUSCLE, SKELETAL (SM) , SPINAL CORD (SC), NERVE, SCIATIC (SN), STOMACH, GL (ST), DUODENUM (DU), PANCREAS (PA), JEJUNUM (JE) , ILEUM (IL) , CECUM (CE) , COLON (CO), RECTUM (RE),
SKIN (SK), MAMMARY, MALE (MM), URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESICLES (SV), EPIDIDYMIDES (EP), TESTIS (TE), ADIPOSE TISSUE (AT), LN, TRACHEOBRON (TB) , LN, ANT MES/PANC (AP)
,
003472
APPENDIX 5 Individual Anatomie Pathology Data
Terminal Sacrifice
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS
Covance 6329-223 3M T-6295.7
PAGE: 29
ANIMAL NUMBER: 105507
SEX: MALE
DOSE GROUP: 4
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 02/25/99
STUDY DAY OF DEATH: 184
STUDY WEEK OF DEATH: 27
TERMINAL BODY WEIGHT: 3870.0 GRAMS
DATE AND TIME OF NECROPSY: 02/25/99 8:11
PROSECTOR: STEVE VAN ADESTINE
RECORDER: TODD ACKER
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: ROBERT LEEDLE
WEIGHER: TODD ACKER
ORGAN NAME
ABSOLUTE ORGAN WEIGHT (GRAMS)
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%)
ORGAN TO BRAIN WEIGHT RATIO
ORGAN STATUS
LEFT ADRENAL (ADO) RIGHT ADRENAL (ADl) BRAIN (BR) LF EPIDIDYMIS (EP0) RT EPIDIDYMIS (EP1) LF KIDNEY (KD0) RT KIDNEY (KD1) LIVER (LI) LF TESTIS (TE0) RT TESTIS (TE1) PANCREAS (PA) LF THYROID/PARA (TTO) RT THYROID/PARA (TT1) GALLBLADDER (GB) BILE(VOLUME) (BI)
.4540 .3210
71.7900 2.0740 2.3260 6.5150 6.2950
112.4190 12.6370 12.5000
5.2280 .2850 .3460 .5330
2.0000 mL
.0117 % .0083 % 1.8550 % .0536 % .0601 % .1683 % .1627 %
2.9049 .3265 % .3230 % .1351 % .0074 % .0089 %
.0063 .0045 1.0000 .0289 .0324 .0908 .0877 1.5659 .1760 .1741
.0728 .0040 .0048
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
NECROPSY
OBSERVATIONS
HISTOPATHOLOGY
BONE, FEMUR (FE) : -GROWTH PLATE OPEN,-SLIGHT
MARROW, FEMUR (FM) : >SECTION EXAMINED; TISSUE NOT PRESENT
BRAIN (BR) :
-INFILTRATE, LYMPHOHISTIOCYTIC, PERIVASCULAR,-MINIMAL
-INFILTRATE, MACROPHAGES, PIGMENTED, PERIVASCULAR,-SLIGHT KIDNEY (KD) :
-INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL -MINERALIZATION, CORTEX,-MINIMAL
003473
724
APPENDIX 5 Individual Anatomic Pathology Data
Terminal Sacrifice
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS
Covance 6329-223 3M T-6295.7
PAGE; 30
ANIMAL NUMBER: 105507
SEX: MALE
DOSE GROUP: 4
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 02/25/99
STUDY DAY OF DEATH: 184
STUDY WEEK OF DEATH: 27
TERMINAL BODY WEIGHT: 3870.0 GRAMS
DATE AND TIME OF NECROPSY: 02/25/99 8:11
PROSECTOR: STEVE VAN ADESTINE
RECORDER: TODD ACKER
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: ROBERT LEEDLE
WEIGHER: TODD ACKER
NECROPSY
O B S E R V A T I O N S (CONTINUED)
HISTOPATHOLOGY
LIVER (LI) : -MOTTLED; ALL LOBES: BROWN AND TAN
LN, MESENTERIC (MS) : -DIFFUSELY RED; DARK RED
ADRENAL, CORTEX (AC) : -DIFFUSELY DARK; BILATERAL: DARK BROWN
GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -EYES - DAVIDSONS
LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR,-MODERATE, DIFFUSE -VACUOLATION, HEPATOCELLULAR, CENTRILOBULAR,-MODERATELY SEVERE
THYMUS (TH) : -CYST.-PRESENT -ATROPHY,-MODERATELY SEVERE
LN, MESENTERIC (MS) : UNREMARKABLE
TRACHEA (TR) :
-INFILTRATE, LYMPHOHISTIOCYTIC,-SLIGHT ADRENAL, CORTEX (AC) :
UNREMARKABLE JEJUNUM (JE) :
-INFILTRATE, MACROPHAGE, PIGMENTED,-MODERATE ILEUM (IL) :
-INFILTRATE, MACROPHAGE, PIGMENTED,-MODERATE PROSTATE (PR) :
-INFLAMMATION, LYMPHOHISTIOCYTIC, -MINIMAL
003474
725
APPENDIX 5 Individual Anatomic Pathology Data
Terminal Sacrifice
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS
Covance 6329-223 3M T-6295.7
PAGE! 31
ANIMAL NUMBER: 105507
SEX: MALE
DOSE GROUP: 4
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 02/25/99
STUDY DAY OF DEATH: 184
STUDY WEEK OF DEATH: 27
TERMINAL BODY WEIGHT: 3870.0 GRAMS
DATE AND TIME OF NECROPSY: 02/25/99 8:11
PROSECTOR: STEVE VAN ADESTINE
RECORDER: TODD ACKER
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: ROBERT LEEDLE
WEIGHER: TODD ACKER
THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE) , BONE, STERNUM (SB), EYE (EY), BRAIN (BR), KIDNEY (KD), LUNG (LU), HEART (HT) , GALLBLADDER (GB) , SPLEEN (SP) , THYMUS (TH) , TRACHEA (TR) , ESOPHAGUS (ES) , THYROID (TY) , PARATHYROID (PT) , ADRENAL, MEDULLA (MA) , AORTA (AO), PITUITARY (PI), SALIV GL, MANDIB (SG) , MUSCLE, SKELETAL (SM) , SPINAL CORD (SC), NERVE, SCIATIC (SN), STOMACH, GL (ST), DUODENUM (DU), PANCREAS (PA), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), SKIN (SK) , MAMMARY, MALE (MM), URINARY BLADDER (UB) , PROSTATE (PR), SEMINAL VESICLES (SV), EPIDIDYMIDES (EP), TESTIS (TE), ADIPOSE TISSUE (AT), LN, TRACHEOBRQN (TB), LN, ANT MES/PANC (AP)
THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: MARROW, STERNUM (SE) , BONE, STERNUM (SB), EYE (EY) , LUNG (LU) , HEART (HT) , GALLBLADDER (GB) , SPLEEN (SP) , ESOPHAGUS (ES), THYROID (TY) , PARATHYROID (PT) , ADRENAL, MEDULLA (MA) , AORTA (AO), PITUITARY (PI), SALIV GL, MANDIB (SG) , MUSCLE, SKELETAL (SM) , SPINAL CORD (SC), NERVE, SCIATIC (SN) , STOMACH, GL (ST), DUODENUM (DU), PANCREAS (PA), CECUM (CE) , COLON (CO), RECTUM (RE), SKIN (SK) , MAMMARY, MALE (MM), URINARY BLADDER (UB), SEMINAL VESICLES (SV), EPIDIDYMIDES (EP), TESTIS (TE)
003475
726
APPENDIX 5 Individual Anatomic Pathology Data
Terminal Sacrifice
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS
Covance 6329-223 3M T-6295.7
PAGE: 32
ANIMAL NUMBER: 105512
SEX: MALE
DOSE GROUP: 4
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 02/25/99
STUDY DAY OF DEATH: 184
STUDY WEEK OF DEATH: 27
TERMINAL BODY WEIGHT: 2285.0 GRAMS
DATE AND TIME OF NECROPSY: 02/25/99 9:21
PROSECTOR: STEVE VAN ADESTINE
RECORDER: TODD ACKER
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: ROBERT LEEDLE
WEIGHER: TODD ACKER
ORGAN NAME
ABSOLUTE ORGAN WEIGHT (GRAMS)
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%)
ORGAN TO BRAIN WEIGHT RATIO
ORGAN STATUS
LEFT ADRENAL (ADO) RIGHT ADRENAL (ADI)
BRAIN (BR) LF EPIDIDYMIS (EP0) RT EPIDIDYMIS (EP1) LF KIDNEY (KD0) RT KIDNEY (KD1) LIVER (LI) LF TESTIS (TE0) RT TESTIS (TE1) PANCREAS (PA) LF THYROID/PARA (TTO) RT THYROID/PARA (TT1) GALLBLADDER (GB) BILE(VOLUME) (BI)
.2790 .2240 60.7370
.5450 .4350 4.5470 4.5140 58.1440 1.4310 1.3310 3.0430 .1190 .1260 .3100 1.2000 mL
.0122 % .0098 % 2.6581 % .0239 % .0190 % .1990 % .1975 % 2.5446 % .0626 % .0582 % .1332 % .0052 % .0055 %
.0046 .0037 1.0000 .0090 .0072
.0749 .0743 .9573 .0236 .0219
.0501 .0020 .0021
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
NECROPSY
OBSERVATIONS
HISTOPATHOLOGY
LIVER (LI) : -MOTTLED; ALL LOBES: BROWN AND TAN
BONE, FEMUR (FE) : -GROWTH PLATE OPEN,-MODERATE
MARROW, FEMUR (FM) : SECTION EXAMINED: TISSUE NOT PRESENT
BRAIN (BR) :
-INFILTRATE, MACROPHAGES, PIGMENTED, PERIVASCULAR,-MINIMAL LIVER (LI) :
-HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR,-SLIGHT GALLBLADDER (GB) :
-INFILTRATE, LYMPHOHISTIOCYTIC,-SLIGHT
003476
727
APPENDIX 5 Individual Anatomic Pathology Data
Terminal Sacrifice
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS
Covance 6329-223 3M T-6295.7
PAGE: 33
ANIMAL NUMBER: 105512
SEX: MALE
DOSE GROUP: 4
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 02/25/99
STUDY DAY OF DEATH: 184
STUDY WEEK OF DEATH: 27
TERMINAL BODY WEIGHT: 2285.0 GRAMS
DATE AND TIME OF NECROPSY: 02/25/99 9:21
PROSECTOR: STEVE VAN ADESTINE
RECORDER: TODD ACKER
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: ROBERT LEEDLE
WEIGHER: TODD ACKER
NECROPSY
O B S E R V A T I O N S (CONTINUED)
HISTOPATHOLOGY
ADRENAL, CORTEX (AC) : -DIFFUSELY DARK; BILATERAL: BROWN
GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -EYES - DAVIDSONS
THYMUS (TH) : -ATROPHY,-MODERATELY SEVERE
LN, MESENTERIC (MS) : -HEMORRHAGE,-MINIMAL
TRACHEA (TR) :
-INFILTRATE, LYMPHOHISTIOCYTIC,-SLIGHT -INFLAMMATION, ACUTE,-MINIMAL ADRENAL, CORTEX (AC) : >UNREMARKABLE SALIV GL, MANDIB (SG) :
-INFILTRATE, LYMPHOHISTIOCYTIC, -MINIMAL JEJUNUM (JE) :
-INFILTRATE, MACROPHAGE, PIGMENTED,-SLIGHT MAMMARY, MALE (MM) :
SECTION EXAMINED; TISSUE NOT PRESENT PROSTATE (PR) :
-INFLAMMATION, LYMPHOHISTIOCYTIC,-MINIMAL EPIDIDYMIDES (EP) :
-HYPOSPERMIA,-SEVERE TESTIS (TE) :
-IMMATURE,-PRESENT
003477
728
APPENDIX 5 Individual Anatomic Pathology Data
Terminal Sacrifice
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS
Covance 6329-223 3M T-6295.7
PAGE: 34
ANIMAL NUMBER: 105512
SEX: MALE
DOSE GROUP: 4
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 02/25/99
STUDY DAY OF DEATH:I: 184
STUDY WEEK OF DEATH: 27
TERMINAL BODY WEIGHT: 2285.0 GRAMS
DATE AND TIME OF NECROPSY: 02/25/99 9:21
PROSECTOR: STEVE VAN ADESTINE
RECORDER: TODD ACKER
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: ROBERT LEEDLE
WEIGHER: TODD ACKER
THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BONE, STERNUM (SB) , EYE (EY) , BRAIN (BR) , KIDNEY (KD) , LUNG (LU), HEART (HT) , GALLBLADDER (GB) , SPLEEN (SP) , THYMUS (TH) , LN, MESENTERIC (MS), TRACHEA (TR) , ESOPHAGUS (ES), THYROID (TY) , PARATHYROID (PT) , ADRENAL, MEDULLA (MA) , AORTA (AO), PITUITARY (PI), SALIV GL, MANDIB (SG) , MUSCLE, SKELETAL (SM) , SPINAL CORD (SC), NERVE, SCIATIC (SN) , STOMACH, GL (ST), DUODENUM (DU) , PANCREAS (PA) , JEJUNUM (JE) , ILEUM (IL) , CECUM (CE) , COLON (CO) , RECTUM (RE) , SKIN (SK) , MAMMARY, MALE (MM), URINARY BLADDER (UB) , PROSTATE (PR), SEMINAL VESICLES (SV) , EPIDIDYMIDES (EP) , TESTIS (TE) , ADIPOSE TISSUE (AT), LN, TRACHEOBRON (TB) , LN, ANT MES/PANC (AP)
THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: MARROW, STERNUM (SE) , BONE, STERNUM (SB), EYE (EY) , KIDNEY (KD) , LUNG (LU) , HEART (HT) , SPLEEN (SP) , ESOPHAGUS (ES), THYROID (TY) , PARATHYROID (PT) , ADRENAL, MEDULLA (MA) , AORTA (AO), PITUITARY (PI), MUSCLE, SKELETAL (SM), SPINAL CORD (SC), NERVE, SCIATIC (SN), STOMACH, GL (ST), DUODENUM (DU), PANCREAS (PA), ILEUM (IL) , CECUM (CE) , COLON (CO), RECTUM (RE), SKIN (SK) , URINARY BLADDER (UB) , SEMINAL VESICLES (SV)
i,
003478
729
APPENDIX 5 Individual Anatomie Pathology Data
Terminal Sacrifice
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS
Covance 6329-223 3M T-6295.7
PAGE: 35
ANIMAL NUMBER: 105530
SEX: FEMALE
DOSE GROUP: 1
SACRIFICE STATUS: SCHEDULED, TERMINAL ;SACRIFICE
DATE OF DEATH: 02/25/99
STUDY DAY OF DEATH: 184
STUDY WEEK OF DEATH: 27
TERMINAL BODY WEIGHT : 2755..0 GRAMS
DATE AND TIME OF NECROPSY: 02/25/99 11:29
PROSECTOR:: KEVIN BILLINGS
RECORDER: MICHELE ZIMA
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: ROBERT LEEDLE
WEIGHER: MICHELE ZIMA
ORGAN NAME
ABSOLUTE ORGAN WEIGHT (GRAMS)
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%)
ORGAN TO BRAIN WEIGHT RATIO
O RGAN STATUS
LEFT ADRENAL (ADO) RIGHT ADRENAL (ADI) BRAIN (BR) LF KIDNEY (KDO) RT KIDNEY (KD1) LIVER (LI) LF OVARY (OVO) RT OVARY (OV1) PANCREAS (PA) LF THYROID/PARA (TTO) RT THYROID/PARA (TT1) GALLBLADDER (GB) BILE(VOLUME) (BI)
.2480 .1640 60.5500 5.6520 5.4770 49.1800 .1220 .1280 4.2470 .2100 .2150 .5970 1.2000 mL
.0090 % .0060 % 2.1978 % .2052 % .1988 % 1.7851 % .0044 % .0046 % .1542 % .0076 % .0078 %
.0041 .0027
1.0000 .0933 .0905 .8122 .0020 .0021 .0701 .0035 .0036
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
WEIGHT TAKEN WEIGHT TAKEN
NECROPSY
OBSERVATIONS
HISTOPATHOLOGY
LUNG (LU) : -ADHESION(S) ; ALL LOBES TO EACH OTHER, PLEURA, PERICARDIAL SAC, AND CAUDAL LOBES TO DIAPHRAGM: MULTIPLE RED, TAN, FIBROUS ADHESIONS; COLLECTED INTACT
BONE, FEMUR (FE) :
-GROWTH PLATE OPEN,-MINIMAL BRAIN (BR) :
-INFILTRATE, MACROPHAGES, PIGMENTED, PERIVASCULAR,-MODERATE KIDNEY (KD) :
-GLOMERULOSCLEROSIS,-MINIMAL LUNG (LU) :
-HYPERPLASIA, LYMPHOCYTIC, PERIBRONCHIOLAR/PERIVASCULAR,MINIMAL
-FIBROSIS, PLEURAL/SUBPLEURAL,-SLIGHT LIVER (LI) :
-INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL, MULTI-FOCAL
003479
730
APPENDIX 5 individual Anatomic Pathology Data
Terminal Sacrifice
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS
Covance 6329-223 3M T-6295.7
PAGE: 36
ANIMAL NUMBER: 105530
SEX: FEMALE
DOSE GROUP: 1
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 02/25/99
STUDY DAY OF DEATH: 184
STUDY WEEK OF DEATH: 27
TERMINAL BODY WEIGHT: 2755.0 GRAMS
DATE AND TIME OF NECROPSY: 02/25/99 11:29
PROSECTOR: KEVIN BILLINGS
RECORDER: MICHELE ZIMA
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: ROBERT LEEDLE
WEIGHER: MICHELE ZIMA
NECROPSY
O B S E R V A T I O N S (CONTINUED)
HISTOPATHOLOGY
GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -EYES - DAVIDSONS
TRACHEA (TR) :
-INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL THYROID (TY) :
-INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL SALIV GL, MANDIB (SG) :
-INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL MUSCLE, SKELETAL (SM) :
-DEGENERATION,-SLIGHT -INFLAMMATION, GRANULOMATOUS,-MODERATE -REGENERATION, MYOFIBER,-MODERATELY SEVERE URINARY BLADDER (UB) :
-INFILTRATE, LYMPHOHISTIOCYTIC, -MINIMAL
003480
731
APPENDIX 5 Individual Anatomic Pathology Data
Terminal Sacrifice
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS
Covance 6329-223 3M T-6295.7
PAGE: 37
ANIMAL NUMBER: 105530
SEX: FEMALE
DOSE GROUP: 1
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 02/25/99
STUDY DAY OF DEATH: 184
STUDY WEEK OF DEATH: 27
TERMINAL BODY WEIGHT: 2755.0 GRAMS
DATE AND TIME OF NECROPSY: 02/25/99 11:29
PROSECTOR: KEVIN BILLINGS
RECORDER: MICHELE ZIMA
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: ROBERT LEEDLE
WEIGHER: MICHELE ZIMA
THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BONE, STERNUM (SB) , EYE (EY) , BRAIN (BR) , KIDNEY (KD) , HEART (HT), LIVER (LI), GALLBLADDER (GB) , SPLEEN (SP) , THYMUS (TH) , LN, MESENTERIC (MS), TRACHEA (TR), ESOPHAGUS (ES) , THYROID (TY) , PARATHYROID (PT) , ADRENAL, CORTEX (AC) , ADRENAL, MEDULLA (MA) , AORTA (AO) , PITUITARY (PI), SALIV GL, MANDIB (SG) , MUSCLE, SKELETAL (SM) , SPINAL CORD (SC), NERVE, SCIATIC (SN) , STOMACH, GL (ST) , DUODENUM (DU) , PANCREAS (PA) , JEJUNUM (JE) , ILEUM (IL) , CECUM (CE) , COLON (CO) , RECTUM (RE) , SKIN (SK), MAMMARY, FEMALE (MF) , URINARY BLADDER (UB) , UTERUS (UT) , OVARY (OV) , VAGINA <VA) , CERVIX (CV) , ADIPOSE TISSUE (AT) , LN, TRACHEOBRON (TB) , LN, ANT MES/PANC (AP)
THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION:
MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BONE, STERNUM (SB) , EYE (EY) , HEART (HT) , GALLBLADDER (GB) , SPLEEN (SP) , THYMUS (TH), LN, MESENTERIC (MS), ESOPHAGUS (ES) , PARATHYROID (PT) , ADRENAL, CORTEX(AC), ADRENAL, MEDULLA (MA) , AORTA (AO), PITUITARY (PI), SPINAL CORD (SC), NERVE, SCIATIC (SN) , STOMACH, GL (ST), DUODENUM (DU), PANCREAS (PA),
JEJUNUM (JE) , ILEUM (IL) , CECUM (CE) , COLON (CO) , RECTUM (RE) , SKIN (SK) , MAMMARY, FEMALE (MF) , UTERUS (UT) , OVARY (OV) , VAGINA (VA) , CERVIX (CV)
003481
732
APPENDIX 5 Individual Anatomic Pathology Data
Terminal Sacrifice
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS
Covance 6329-223 3M T-6295.7
PAGE: 38
ANIMAL NUMBER: 105531
SEX: FEMALE
DOSE GROUP: 1
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 02/26/99
STUDY DAY OF DEATH: 185
STUDY WEEK OF DEATH: 27
TERMINAL BODY WEIGHT: 2625.0 GRAMS
DATE AND TIME OF NECROPSY: 02/26/99 7:15
PROSECTOR: STEVE VAN ADESTINE
RECORDER: JOHN S. HALFORD
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: ROBERT LEEDLE
WEIGHER: JOHN S. HALFORD
ORGAN NAME
ABSOLUTE ORGAN WEIGHT (GRAMS)
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%)
ORGAN TO BRAIN WEIGHT RATIO
ORGAN STATUS
LEFT ADRENAL (ADO) RIGHT ADRENAL (ADl) BRAIN (BR) LF KIDNEY (KDO) RT KIDNEY (KD1) LIVER (LI) LF OVARY (OVO) RT OVARY (OV1) PANCREAS (PA) LF THYROID/PARA (TTO) RT THYROID/PARA (TT1) GALLBLADDER (GB) BILE(VOLUME) (BI)
.2360 .1480 54.3050 4.3520 4.2910 42.1310 .0990 .0930 3.9080 .1970 .1740 .7250 1.8000 mL
.0090 % .0056 % 2.0688 % .1658 % .1635 % 1.6050 % .0038 % .0035 % .1489 % .0075 % .0066
.0043 .0027
1.0000 .0801 .0790 .7758 .0018 .0017
.0720 .0036 .0032
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
WEIGHT TAKEN WEIGHT TAKEN
NECROPSY
OBSERVATIONS
HISTOPATHOLOGY
MARROW, FEMUR (FM) :
SECTION EXAMINED; TISSUE NOT PRESENT BRAIN (BR) :
-INFILTRATE, MACROPHAGES, PIGMENTED, PERIVASCULAR,-SLIGHT KIDNEY (KD) ;
-INFILTRATE, LYMPHOHISTIOCYTIC,-SLIGHT LIVER (LI) :
-INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL, MULTI-FOCAL ADRENAL, CORTEX (AC) :
-HYPERTROPHY, CORTICAL CELL,-MINIMAL JEJUNUM (JE) :
-INFILTRATE, MACROPHAGE, PIGMENTED,-MODERATE
G 034S2
733
APPENDIX 5 Individual Anatomic Pathology Data
Terminal Sacrifice
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS
Covance 6329-223 3M T-6295.7
PAGE: 39
ANIMAL NUMBER: 105531
SEX: FEMALE
DOSE GROUP: 1
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 02/26/99
STUDY DAY OF DEATH: 185
STUDY WEEK OF DEATH: 27
TERMINAL BODY WEIGHT: 2625.0 GRAMS
DATE AND TIME OF NECROPSY: 02/26/99 7:15
PROSECTOR: STEVE VAN ADESTINE
RECORDER: JOHN S. HALFORD
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: ROBERT LEEDLE
WEIGHER: JOHN S. HALFORD
NECROPSY
O B S E R V A T I O N S (CONTINUED)
HISTOPATHOLOGY
GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -EYES - DAVIDSONS -NO MACROSCOPIC LESIONS
ILEUM (IL) : -INFILTRATE, MACROPHAGE, PIGMENTED,-MINIMAL
UTERUS (UT) : -AMYLOID, -SLIGHT
THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY:
BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BONE, STERNUM (SB), EYE (EY) , BRAIN (BR) , KIDNEY (KD) , LUNG (LU), HEART (HT) , LIVER (LI), GALLBLADDER (GB) , SPLEEN (SP) , THYMUS (TH) , LN, MESENTERIC (MS), TRACHEA (TR) , ESOPHAGUS (ES) , THYROID (TY) , PARATHYROID (PT) , ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , AORTA (AO), PITUITARY (PI), SALIV GL, MANDIB (SG) , MUSCLE, SKELETAL (SM) , SPINAL CORD (SC), NERVE, SCIATIC (SN) , STOMACH, GL (ST) , DUODENUM (DU) , PANCREAS (PA) , JEJUNUM (JE) , ILEUM (IL) , CECUM(CE) , COLON (CO) , RECTUM (RE) , SKIN (SK) , MAMMARY, FEMALE (MF) , URINARY BLADDER (UB) , UTERUS (UT) , OVARY (OV) ,VAGINA (VA) , CERVIX (CV) , ADIPOSE TISSUE (AT), LN, TRACHEOBRON (TB) , LN, ANT MES/PANC (AP)
THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE) , MARROW, STERNUM (SE) , BONE, STERNUM (SB), EYE (EY) , LUNG (LU) , HEART (HT) , GALLBLADDER (GB) , SPLEEN (SP), THYMUS (TH) , LN, MESENTERIC (MS), TRACHEA (TR) , ESOPHAGUS (ES) , THYROID (TY) , PARATHYROID (PT) , ADRENAL, MEDULLA (MA) , AORTA (AO), PITUITARY (PI), SALIV GL, MANDIB (SG) , MUSCLE, SKELETAL (SM) , SPINAL CORD (SC), NERVE, SCIATIC (SN) , STOMACH, GL (ST), DUODENUM (DU), PANCREAS (PA), CECUM (CE) , COLON (CO), RECTUM (RE), SKIN (SK), MAMMARY, FEMALE (MF) , URINARY BLADDER (UB) , OVARY (OV) , VAGINA (VA) ,CERVIX (CV)
003483
734
APPENDIX 5 Individual Anatomic Pathology Data
Terminal Sacrifice
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS
Covance 6329-223 3M T-6295.7
PAGE: 40
ANIMAL NUMBER: 105535
SEX: FEMALE
DOSE GROUP: 1
SACRIFICE STATUS: SCHEDULED, TERMINAL 1SACRIFICE
DATE OF DEATH: 02/26/99
STUDY DAY OF DEATH:: 185
STUDY WEEK OF DEATH: 27
TERMINAL BODY WEIGHT : 3270..0 GRAMS
DATE AND TIME OF NECROPSY: 02/26/99 8:13
PROSECTOR:: KEVIN BILLINGS
RECORDER: MICHELE ZIMA
POST--FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: ROBERT LEEDLE
WEIGHER: MICHELE ZIMA
ORGAN NAME
ABSOLUTE ORGAN WEIGHT (GRAMS)
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%)
ORGAN TO BRAIN WEIGHT RATIO
ORGAN STATUS
LEFT ADRENAL (ADO) RIGHT ADRENAL (ADl) BRAIN (BR) LF KIDNEY (KDO) RT KIDNEY (KD1) LIVER (LI) LF OVARY (OVO) RT OVARY (OV1) PANCREAS (PA) LF THYROID/PARA (TTO) RT THYROID/PARA (TT1) GALLBLADDER (GB) BILE(VOLUME) (BI)
.3770 ,3150 51.9670 6.6940 6.1830 64.3990 .2280 .2100 5.0450 .4660
.4370 .6970 2.6000 mL
.0115 .0096 % 1.5892 % .2047 .1891 % 1.9694 .0070 % .0064 % .1543 .0143 % .0134 %
.0073 .0061 1.0000 .1288 .1190 1.2392 .0044
.0040 .0971 .0090 .0084
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
WEIGHT TAKEN WEIGHT TAKEN
NECROPSY
OBSERVATIONS
HISTOPATHOLOGY
LUNG (LU) : -ADHESION(S) ; ALL LOBES TO EACH OTHER, PLEURA, AND PERICARDIAL SAC: MULTIPLE RED, TAN, FIBROUS ADHESIONS; COLLECTED INTACT
MARROW, FEMUR (FM) : SECTION EXAMINED; TISSUE NOT PRESENT
LUNG (LU) : -FIBROSIS, PLEURAL/SUBPLEURAL,-SEVERE -FIBROSIS, INTERSTITIAL,-MODERATELY SEVERE
LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL, MULTI-FOCAL -VACUOLATION, HEPATOCELLULAR,-MINIMAL, MULTI-FOCAL
SALIV GL, MANDIB (SG) : -INFILTRATE, LYMPHOHISTIOCYTIC,-SLIGHT
003484
735
APPENDIX 5 Individual Anatomic Pathology Data
Terminal Sacrifice
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS
Covance 6329-223 3M T-6295.7
PAGE: 41
ANIMAL NUMBER: 105535
SEX: FEMALE
DOSE GROUP: 1
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 02/26/99
STUDY DAY OF DEATH: 185
STUDY WEEK OF DEATH: 27
TERMINAL BODY WEIGHT: 3270.0 GRAMS
DATE AND TIME OF NECROPSY: 02/26/99 8:13
PROSECTOR: KEVIN BILLINGS
RECORDER: MICHELE ZIMA
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: ROBERT LEEDLE
WEIGHER: MICHELE ZIMA
NECROPSY
O B S E R V A T I O N S (CONTINUED)
HISTOPATHOLOGY
STOMACH, GL (ST) : -RED FOCUS(I)/AREA(S); MUCOSA, FUNDIC: SINGLE RED FOCUS, 0.3 MM IN DIAMETER; FOCUS HAS A STELLATE PATTERN >NOTE:>FUNDIC MUCOSA, ALONG GREATER CURVATURE: SINGLE APPARENT HOOK WORM EMBEDDED INTO MUCOSA, 3.0 X 0.1 X 0.1 CM
GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -EYES - DAVIDSONS
GENERAL INFORMATION (XX) : >NOTE:>ANIMAL APPEARS TO BE IN ESTROUS
STOMACH, GL (ST) : UNREMARKABLE
DUODENUM (DU) : -INFILTRATE, MACROPHAGE, PIGMENTED,-MODERATE
JEJUNUM (JE) : -INFILTRATE, MACROPHAGE, PIGMENTED,-MODERATE
ILEUM (IL) : -INFILTRATE, MACROPHAGE, PIGMENTED,-MODERATE
CECUM (CE) : -INFILTRATE, MACROPHAGE, PIGMENTED,-SLIGHT
MAMMARY, FEMALE (MF) : -INFLAMMATION, ACUTE,-MINIMAL
URINARY BLADDER (UB) : -INFILTRATE, LYMPHOHISTIOCYTIC, -MINIMAL
UTERUS (UT) : -AMYLOID, -SLIGHT
oo
CO
c0n0 736
APPENDIX 5 Individual Anatomic Pathology Data
Terminal Sacrifice
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS.-T-6295) IN CYNOMOLGUS MONKEYS
Covance 6329-223 3M T-6295.7
PAGE: 42
ANIMAL NUMBER: 105535
SEX: FEMALE
DOSE GROUP: 1
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 02/26/99
STUDY DAY OF DEATH: 185
STUDY WEEK OF DEATH: 27
TERMINAL BODY WEIGHT: 3270.0 GRAMS
DATE AND TIME OF NECROPSY: 02/26/99 8:13
PROSECTOR: KEVIN BILLINGS
RECORDER: MICHELE ZIMA
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: ROBERT LEEDLE
WEIGHER: MICHELE ZIMA
THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY:
BONE, FEMUR (FE),MARROW, FEMUR (FM) , MARROW, STERNUM (SE) ,BONE, STERNUM (SB), EYE (EY) , BRAIN (BR) , KIDNEY (KD),
HEART (HT), LIVER
(LI), GALLBLADDER (GB) , SPLEEN (SP) , THYMUS (TH) , LN, MESENTERIC (MS),
TRACHEA (TR) ,
ESOPHAGUS (ES), THYROID (TY) , PARATHYROID (PT) , ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , AORTA (AO),
PITUITARY (PI), SALIV GL, MANDIB (SG) . MUSCLE, SKELETAL (SM) , SPINAL CORD (SC), NERVE, SCIATIC (SN) , DUODENUM (DU),
PANCREAS (PA), JEJUNUM (JE) , ILEUM (IL) , CECUM (CE) , COLON (CO), RECTUM (RE), SKIN (SK) , MAMMARY, FEMALE (MF) ,
URINARY BLADDER (UB) , UTERUS (UT) , OVARY (OV) , VAGINA (VA) , CERVIX (CV) , ADIPOSE TISSUE (AT) , LN, TRACHEOBRON (TB) ,
LN, ANT MES/PANC (AP)
THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION:
BONE, FEMUR (FE),MARROW, STERNUM (SE) , BONE, STERNUM (SB), EYE (EY) , BRAIN (BR) , KIDNEY (KD) , HEART (HT) , GALLBLADDER (GB),SPLEEN (SP) , THYMUS (TH) , LN, MESENTERIC (MS), TRACHEA (TR) , ESOPHAGUS (ES) , THYROID (TY) , PARATHYROID (PT) , ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , AORTA (AO), PITUITARY (PI), MUSCLE, SKELETAL (SM) , SPINAL CORD (SC), NERVE, SCIATIC (SN) , PANCREAS (PA), COLON (CO), RECTUM (RE), SKIN (SK) , OVARY (OV) , VAGINA (VA) , CERVIX (CV)
0034S6
737
APPENDIX 5 Individual Anatomic Pathology Data
Terminal Sacrifice
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS
Covance 6329-223 3M T-6295.7
PAGE: 43
ANIMAL NUMBER: 105544
SEX: FEMALE
DOSE GROUP: 1
SACRIFICE STATUS: SCHEDULED, TERMINAL lSACRIFICE
DATE OF DEATH: 02/25/99
STUDY DAY OF DEATH: 184
STUDY WEEK OF DEATH: 27
TERMINAL BODY WEIGHT : 2635..0 GRAMS
DATE AND TIME OF NECROPSY: 02/25/99 9:55
PROSECTOR: KEVIN BILLINGS
RECORDER: MICHELE ZIMA
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: ROBERT LEEDLE
WEIGHER: MICHELE ZIMA
ORGAN NAME
ABSOLUTE ORGAN WEIGHT (GRAMS)
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%)
ORGAN TO BRAIN WEIGHT RATIO
ORGAN STATUS
LEFT ADRENAL (ADO) RIGHT ADRENAL (ADI)
BRAIN (BR) LF KIDNEY (KDO) RT KIDNEY (KD1) LIVER (LI) LF OVARY (OVO) RT OVARY (OV1) PANCREAS (PA) LF THYROID/PARA (TTO) RT THYROID/PARA (TTl) GALLBLADDER (GB) BILE(VOLUME) (BI)
.3120 .2440 59.7410 5.3110 5.2470 48.6600 .2260 .1380 4.5080 .1540 .1560 .3810 2.2000 mL
.0118 %
.0093 % 2.2672 %
.2016 .1991 % 1.8467 % .0086 %
.0052 .1711 % .0058 % .0059 t
.0052 .0041 1.0000 .0889 .0878 .8145 .0038 .0023 .0755 .0026 .0026
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
NECROPSY
OBSERVATIONS
HISTOPATHOLOGY
LIVER (LI) : -LIGHT FOCUS (I)/AREA (S) ; TRIM COMMENT: DIAPHRAGMATIC SURFACE OF LEFT LATERAL LOBE: SINGLE TAN AREA, 1.0 CM IN DIAMETER;
SUBMITTED ON ROUTINE SECTION
MARROW, STERNUM (SE) : -HYPOCELLULAR, MARROW,-SLIGHT
BRAIN (BR) : -INFILTRATE, MACROPHAGES, PIGMENTED, PERIVASCULAR,-MODERATE
LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL, MULTI-FOCAL
GALLBLADDER (GB) : -INFILTRATE, LYMPHOHISTIOCYTIC, -MINIMAL
LN, MESENTERIC (MS) : -INFILTRATE, MACROPHAGE, PIGMENTED,-MODERATE
003487
738
APPENDIX 5 Individual Anatomic Pathology Data
Terminal Sacrifice
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS
Covance 6329-223 3M T-6295.7
PAGE: 44
ANIMAL NUMBER: 105544
SEX: FEMALE
DOSE GROUP: 1
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 02/25/99
STUDY DAY OF DEATH: 184
STUDY WEEK OF DEATH: 27
TERMINAL BODY WEIGHT: 2635.0 GRAMS
DATE AND TIME OF NECROPSY: 02/25/99 9:55
PROSECTOR: KEVIN BILLINGS
RECORDER: MICHELE ZIMA
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: ROBERT LEEDLE
WEIGHER: MICHELE ZIMA
NECROPSY
O B S E R V A T I O N S (CONTINUED)
HISTOPATHOLOGY
GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -EYES - DAVIDSONS
TRACHEA (TR) : -INFILTRATE, LYMPHOHISTIOCYTIC,-SLIGHT
ESOPHAGUS (ES) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL
PARATHYROID (PT) : SECTION EXAMINED; TISSUE NOT PRESENT
MUSCLE, SKELETAL (SM) :
-PARASITES, CYST,-PRESENT NOTE:HEAVY BURDEN, SARCOCYST-LIKE. DUODENUM (DU) :
-INFILTRATE, MACROPHAGE, PIGMENTED,-SLIGHT JEJUNUM (JE) :
-INFILTRATE, MACROPHAGE, PIGMENTED,-SLIGHT ILEUM (IL) :
-INFILTRATE, MACROPHAGE, PIGMENTED,-SLIGHT MAMMARY, FEMALE (MF) :
-INFILTRATE, LYMPHOHISTIOCYTIC,-SLIGHT URINARY BLADDER (UB) :
-INFILTRATE, LYMPHOHISTIOCYTIC,-SLIGHT OVARY (OV) :
-MINERALIZATION, -MODERATE
003488
739
APPENDIX 5 Individual Anatomic Pathology Data
Terminal Sacrifice
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS
Covance 6329-223 3M T-6295.7
PAGE: 45
ANIMAL NUMBER: 105544
SEX: FEMALE
DOSE GROUP: 1
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 02/25/99
STUDY DAY OF DEATH: 184
STUDY WEEK OF DEATH: 27
TERMINAL BODY WEIGHT: 2635.0 GRAMS
DATE AND TIME OF NECROPSY: 02/25/99 9:55
PROSECTOR: KEVIN BILLINGS
RECORDER: MICHELE ZIMA
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: ROBERT LEEDLE
WEIGHER: MICHELE ZIMA
THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BONE, STERNUM (SB) , EYE (EY) , BRAIN (BR) , KIDNEY (KD) , LUNG (LU), HEART (HT), GALLBLADDER (GB), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), TRACHEA (TR), ESOPHAGUS (ES), THYROID (TY) , PARATHYROID (PT) , ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , AORTA (AO), PITUITARY (PI), SALIV GL, MANDIB (SG), MUSCLE, SKELETAL (SM),SPINAL CORD (SC), NERVE, SCIATIC (SN), STOMACH, GL (ST), DUODENUM (DU), PANCREAS (PA), JEJUNUM (JE),ILEUM (IL) ,CECUM (CE), COLON (CO), RECTUM (RE), SKIN (SK) , MAMMARY, FEMALE (MF) , URINARY BLADDER (UB) , UTERUS (UT) , OVARY (OV) ,VAGINA (VA) , CERVIX (CV) , ADIPOSE TISSUE (AT), LN, TRACHEOBRON (TB), LN, ANT MES/PANC (AP)
THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE) , MARROW, FEMUR (FM) , BONE, STERNUM (SB) , EYE (EY) , KIDNEY (KD) , LUNG (LU) , HEART (HT) , SPLEEN (SP), THYMUS (TH) , THYROID (TY) , ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , AORTA (AO), PITUITARY (PI), SALIV GL, MANDIB (SG) , SPINAL CORD (SC), NERVE, SCIATIC (SN),STOMACH, GL (ST), PANCREAS (PA), CECUM (CE), COLON (CO), RECTUM (RE), SKIN (SK), UTERUS (UT), VAGINA (VA),CERVIX (CV)
003489
740
APPENDIX 5 individual Anatomic Pathology Data
Terminal Sacrifice
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS
Covance G329-223 3M T-6295.7
PAGE: 46
ANIMAL NUMBER: 105537
SEX: FEMALE
DOSE GROUP: 2
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 02/25/99
STUDY DAY OF DEATH: 184
STUDY WEEK OF DEATH: 27
TERMINAL BODY WEIGHT: 4055.0 GRAMS
DATE AND TIME OF NECROPSY: 02/25/99 7:31
PROSECTOR: STEVE VAN ADESTINE
RECORDER: TODD ACKER
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: ROBERT LEEDLE
WEIGHER: TODD ACKER
ORGAN NAME
ABSOLUTE ORGAN WEIGHT (GRAMS)
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%)
ORGAN TO BRAIN WEIGHT RATIO
ORGAN STATUS
LEFT ADRENAL (ADO) RIGHT ADRENAL (ADl)
BRAIN (BR) LF KIDNEY (KD0) RT KIDNEY (KD1)
LIVER (LI) LF OVARY (OV0) RT OVARY (OV1) PANCREAS (PA) LF THYROID/PARA (TT0) RT THYROID/PARA (TT1) GALLBLADDER (GB) BILE(VOLUME) (BI)
.3730 .3030 61.3750 7.0240 6.6650 75.2140 .2790 .2280 6.1370 .3200 .3400 .5100 3.0000 mL
.0092 % .0075 %
1.5136 % .1732 % .1644
1.8548 % .0069 .0056 % .1513 % .0079 %
.0084 %
.0061 .0049 1.0000 .1144 .1086 1.2255 .0045 .0037 .1000 .0052
.0055
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
NECROPSY
OBSERVATIONS
HISTOPATHOLOGY
GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -EYES - DAVIDSONS -ANIMAL OBESE
003490
741
APPENDIX 5 Individual Anatomic Pathology Data
Terminal Sacrifice
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS
Covance 6329-223 3M T-6295.7
PAGE: 47
ANIMAL NUMBER: I05S37
SEX: FEMALE
DOSE GROUP: 2
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 02/25/99
STUDY DAY OF DEATH: 184
STUDY WEEK OF DEATH: 27
TERMINAL BODY WEIGHT: 4055.0 GRAMS
DATE AND TIME OF NECROPSY: 02/25/99 7:31
PROSECTOR: STEVE VAN ADESTINE
RECORDER: TODD ACKER
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: ROBERT LEEDLE
WEIGHER: TODD ACKER
ORGAN NAME
ABSOLUTE ORGAN WEIGHT (GRAMS)
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%>
ORGAN TO BRAIN WEIGHT RATIO
ORGAN STATUS
LEFT ADRENAL (ADO ) RIGHT ADRENAL (ADI) BRAIN (BR) LF KIDNEY (KD0) RT KIDNEY (KD1) LIVER (LI) LF OVARY (OV0) RT OVARY (OV1)
PANCREAS (PA) LF THYROID/PARA (TT0 ) RT THYROID/PARA (TT1 )
.3730 .3030 61.3750 7.0240 6.6650 75.2140 .2790 .2280 6.1370 .3200 .3400
.0092 % .0075 % 1.5136 %
.1732 % .1644 % 1.8548 % .0069 %
.0056 % .1513 % .0079 % .0084 %
.0061 .0049 1.0000 .1144 .1086 1.2255 .0045
.0037 .1000 .0052 .0055
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
NECROPSY
OBSERVATIONS
HISTOPATHOLOGY
GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -EYES - DAVIDSONS -ANIMAL OBESE
GENERAL INFORMATION (XX) : >NOTE:>GALLBLADDER WEIGHT IS 0.5100 GRAMS BILE VOLUME IS 3.0000 ML
LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL, MULTI-FOCAL
THYMUS (TH) : -ATROPHY,-MINIMAL
SPINAL CORD (SC) : -PIGMENT, NEURONAL,-SLIGHT
003491
APPENDIX 5 Individual Anatomic Pathology Data
Terminal Sacrifice
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS
Covance 6329-223 3M T-6295.7
PAGE: 48
ANIMAL NUMBER: 105537
SEX: FEMALE
DOSE GROUP: 2
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 02/25/99
STUDY DAY OF DEATH: 184
STUDY WEEK OF DEATH: 27
TERMINAL BODY WEIGHT: 4055.0 GRAMS
DATE AND TIME OF NECROPSY: 02/25/99 7:31
PROSECTOR: STEVE VAN ADESTINE
RECORDER: TODD ACKER
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: ROBERT LEEDLE
WEIGHER: TODD ACKER
THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SB), BONE, STERNUM (SB), EYE (EY) , BRAIN (BR) , KIDNEY (KD) , LUNG (LU), HEART (HT) , LIVER (LI), GALLBLADDER (GB) , SPLEEN (SP) , THYMUS (TH) , LN, MESENTERIC (MS), TRACHEA (TR) , ESOPHAGUS (ES) , THYROID (TY) , PARATHYROID (PT) , ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , AORTA (AO), PITUITARY (PI), SALIV GL, MANDIB (SG) , MUSCLE, SKELETAL (SM) , SPINAL CORD (SC), NERVE, SCIATIC (SN) , STOMACH, GL (ST), DUODENUM (DU), PANCREAS (PA), JEJUNUM (JE) , ILEUM IIL) ,CECUM (CE) , COLON (CO), RECTUM (RE), SKIN (SK), MAMMARY, FEMALE (MF) , URINARY BLADDER (UB) , UTERUS (UT) , OVARY (OV) , VAGINA (VA) , CERVIX (CV) , ADIPOSE TISSUE (AT), LN, TRACHEOBRON (TB) , LN, ANT MES/PANC (AP)
I,
003492
APPENDIX 5 Individual Anatomic Pathology Data
Terminal Sacrifice
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS
Covance 6329-223 3M T-6295.7
PAGE: 49
ANIMAL NUMBER: 105541
SEX: FEMALE
DOSE GROUP: 2
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 02/26/99
STUDY DAY OF DEATH: 185
STUDY WEEK OF DEATH: 27
TERMINAL BODY WEIGHT: 2510.0 GRAMS
DATE AND TIME OF NECROPSY: 02/26/99 9:47
PROSECTOR: STEVE VAN ADESTINE
RECORDER: JOHN S. HALFORD
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: ROBERT LEEDLE
WEIGHER: JOHN S. HALFORD
ORGAN NAME
ABSOLUTE ORGAN WEIGHT (GRAMS)
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%|
ORGAN TO BRAIN WEIGHT RATIO
ORGAN STATUS
LEFT ADRENAL (ADO) RIGHT ADRENAL (ADI) BRAIN (BR)
LF KIDNEY (KD0) RT KIDNEY (KD1) LIVER (LI) LF OVARY (OVO) RT OVARY (OV1) PANCREAS (PA) LF THYROID/PARA (TT0) RT THYROID/PARA (TT1
.4170 .3060 63.2760
4.9450 4.6880 47.6610
.1240 .1570 5.0750 .2130 .2300
.0166 % .0122 % 2.5210 %
.1970 %
.1868 % 1.8988 %
.0049 % .0063 % .2022 % .0085 % .0092 %
.0066 .0048 1.0000 .0781
.0741 .7532 .0020 .0025 .0802 .0034 .0036
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
WEIGHT TAKEN WEIGHT TAKEN
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
NECROPSY
OBSERVATIONS
HISTOPATHOLOGY
LUNG (LU) : -ADHESION(S! ; RIGHT AND LEFT CAUDAL LOBES AND LEFT INTERMEDIATE LOBE TO DIAPHRAGM: MULTIPLE TAN, FIBROUS ADHESIONS; COLLECTED INTACT -DARK FOCUS(I)/AREA(S); ALL LOBES: MULTIPLE DARK BROWN AREAS, PINPOINT AND UP TO 0.7 X 0.4 CM
LIVER (LI) : -ADHESION (S) ; DIAPHRAGMATIC SURFACE OF RIGHT LATERAL LOBE TO SURROUNDING MESENTERY, ALONG MARGIN: MULTIPLE TAN, FIBROUS ADHESIONS (CAP 29)
LUNG (LU) : >NOT REQUIRED TO BE EXAMINED FOR ANIMAL
LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL, MULTI-FOCAL
THYMUS (TH) : -ATROPHY,-MODERATE
SPINAL CORD (SC) : -PIGMENT, NEURONAL,-MODERATE
003493
APPENDIX 5 Individual Anatomic Pathology Data
Terminal Sacrifice
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS.-T-6295 ) IN CYNOMOLGUS MONKEYS
Covance 6329-223 3M T-6295.7
PAGE: 50
ANIMAL NUMBER: 105541
SEX: FEMALE
DOSE GROUP: 2
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 02/26/99
STUDY DAY OF DEATH: 185
STUDY WEEK OF DEATH: 27
TERMINAL BODY WEIGHT: 2510.0 GRAMS
DATE AND TIME OF NECROPSY: 02/26/99 9:47
PROSECTOR: STEVE VAN ADESTINE
RECORDER: JOHN S. HALFORD
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: ROBERT LEEDLE
WEIGHER: JOHN S. HALFORD
NECROPSY
O B S E R V A T I O N S (CONTINUED)
HISTOPATHOLOGY
GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -EYES - DAVIDSONS
GENERAL INFORMATION (XX) : >NOTE:>GALLBLADDER WEIGHT IS 0.5260 GRAMS BILE VOLUME IS 1.0000 ML
THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE|, MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), KIDNEY (KD), HEART (HT) , GALLBLADDER (GB) , SPLEEN |SP) , THYMUS (TH) , LN, MESENTERIC (MS), TRACHEA (TR) , ESOPHAGUS (ES), THYROID (TY) , PARATHYROID (PT) , ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , AORTA (AO), PITUITARY (PI), SALIV GL, MANDIB (SG) , MUSCLE, SKELETAL (SM), SPINAL CORD (SC), NERVE, SCIATIC (SN) , STOMACH, GL (ST), DUODENUM (DU), PANCREAS (PA), JEJUNUM (JE) , ILEUM (IL) , CECUM (CE) , COLON (CO), RECTUM (RE), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), OVARY (OV), VAGINA (VA), CERVIX (CV), ADIPOSE TISSUE (AT), LN, TRACHEOBRON ITB), LN, ANT MES/PANC (AP)
APPENDIX 5 Individual Anatomic Pathology Data
Terminal Sacrifice
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT <PFOS;T-6295) IN CYNOMOLGUS MONKEYS
Covance 6329-223 3M T-6295.7
PAGE: 51
ANIMAL NUMBER: 105547
SEX: FEMALE
DOSE GROUP: 2
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 02/26/99
STUDY DAY OF DEATH: 185
STUDY WEEK OF DEATH: 27
TERMINAL BODY WEIGHT: 2570.0 GRAMS
DATE AND TIME OF NECROPSY: 02/26/99 9:20
PROSECTOR: STEVE VAN ADESTINE
RECORDER: JOHN S. HALFORD
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: ROBERT LEEDLE
WEIGHER: JOHN S. HALFORD
ORGAN NAME
ABSOLUTE ORGAN WEIGHT (GRAMS)
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%)
ORGAN TO BRAIN WEIGHT RATIO
ORGAN STATUS
LEFT ADRENAL (ADO) RIGHT ADRENAL (ADI) BRAIN (BR) LF KIDNEY (KD0) RT KIDNEY (KD1) LIVER (LI) LF OVARY (OVO) RT OVARY (OV1) PANCREAS (PA)
LF THYROID/PARA (TTO ) RT THYROID/PARA (TT1) .
.3130 .2300 60.8690 5.4180 5.5840 49.9520 .1590
.2030 5.1480
.1550 .1410
.0122 % .0089 % 2.3684 % .2108 % .2173 % 1.9437 % .0062 % .0079 % .2003 % .0060 % .0055 %
,0051 .0038 1.0000 .0890 .0917 .8206 .0026
.0033 .0846 .0025 .0023
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
WEIGHT TAKEN WEIGHT TAKEN
NECROPSY
OBSERVATIONS
HISTOPATHOLOGY
LUNG (LU) : -ADHESION(S) ; LEFT CAUDAL LOBE TO DIAPHRAGM: MULTIPLE TAN, FIBROUS ADHESIONS; COLLECTED INTACT -DARK FOCUS(I)/AREA(S); ALL LOBES: MULTIPLE DARK BROWN AREAS, PINPOINT AND UP TO 0.5 X 0.3 CM
GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -EYES - DAVIDSONS
LUNG (LU) : >NOT REQUIRED TO BE EXAMINED FOR ANIMAL
LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL, MULTI-FOCAL
THYMUS (TH) : -CYST,-PRESENT -ATROPHY,-SLIGHT
003495
APPENDIX 5 Individual Anatomic Pathology Data
Terminal Sacrifice
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT IPFOS;T-6295) IN CYNOMOLGUS MONKEYS
Covance 6329-223 3M T-6295.7
PAGE: 52
ANIMAL NUMBER: 105547
SEX: FEMALE
DOSE GROUP: 2
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 02/26/99
STUDY DAY OF DEATH: 185
STUDY WEEK OF DEATH: 27
TERMINAL BODY WEIGHT: 2570.0 GRAMS
DATE AND TIME OF NECROPSY: 02/26/99 9:20
PROSECTOR: STEVE VAN ADESTINE
RECORDER: JOHN S. HALFORD
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: ROBERT LEEDLE
WEIGHER: JOHN S. HALFORD
NECROPSY
O B S E R V A T I O N S (CONTINUED)
HISTOPATHOLOGY
GENERAL INFORMATION (XX) : >NOTE :>GALLBLADDER WEIGHT IS 0.5380 GRAMS BILE VOLUME IS 1.2000 ML
THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BONE, STERNUM (SB), EYE (EY) , BRAIN (BR) , KIDNEY (KD) , HEART (HT), LIVER (LI), GALLBLADDER (GB) , SPLEEN (SP) , THYMUS (TH) , LN, MESENTERIC (MS), TRACHEA ITR) , ESOPHAGUS (ES), THYROID <TY) , PARATHYROID (PT) , ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , AORTA (AO), PITUITARY (PI), SALIV GL, MANDIB (SG) , MUSCLE, SKELETAL (SM) , SPINAL CORD (SC), NERVE, SCIATIC (SN) , STOMACH, GL (ST), DUODENUM (DU), PANCREAS (PA), JEJUNUM (JE) , ILEUM (IL), CECUM (CE) , COLON (CO), RECTUM (RE), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB|, UTERUS <UT), OVARY (OV),VAGINA (VA), CERVIX (CV) , ADIPOSE TISSUE (AT), LN, TRACHEOBRON (TB) , LN, ANT MES/PANC (AP)
THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: SPINAL CORD (SC)
003496
APPENDIX 5 Individual Anatomic Pathology Data
Terminal Sacrifice
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS
Covance 6329-223 3M T-629S.7
PAGE: 53
ANIMAL NUMBER: 105550
SEX: FEMALE
DOSE GROUP: 2
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 02/26/99
STUDY DAY OF DEATH: 185
STUDY WEEK OF DEATH: 27
TERMINAL BODY WEIGHT: 2820.0 GRAMS
DATE AND TIME OF NECROPSY: 02/26/99 6:43
PROSECTOR: KEVIN BILLINGS
RECORDER: MICHELE 2IMA
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: ROBERT LEEDLE
WEIGHER: MICHELE ZIMA
ORGAN NAME
ABSOLUTE ORGAN WEIGHT (GRAMS)
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%)
ORGAN TO BRAIN WEIGHT RATIO
ORGAN STATUS
LEFT ADRENAL (ADO) RIGHT ADRENAL (ADI) BRAIN (BR) LF KIDNEY (KD0) RT KIDNEY (KD1) LIVER (LI) LF OVARY (OVO) RT OVARY (OV1)
PANCREAS (PA) LF THYROID/PARA (TT0) RT THYROID/PARA (TT1)
.4230 .2680 56.9130 6.0900 6.1500 54.4840 .1270
.1270 7.2830
.1670 .2290
.0150 % .0095 % 2.0182 % .2160 % .2181 % 1.9321 % .0045 % .0045 % .2583 % .0059 % .0081 %
.0074 .0047 1.0000 .1070 .1081 .9573 .0022
.0022 .1280 .0029 .0040
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
NECROPSY
OBSERVATIONS
HISTOPATHOLOGY
LUNG (LU) : -ADHESION (S) ; ALL LOBES TO EACH OTHER, PLEURA, PERICARDIAL SAC, CAUDAL LOBES TO DIAPHRAGM: MULTIPLE RED, TAN, FIBROUS ADHESIONS; COLLECTED INTACT
GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -EYES - DAVIDSONS
LUNG (LU) : >NOT REQUIRED TO BE EXAMINED FOR ANIMAL
LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL, MULTI-FOCAL -VACUOLATION, HEPATOCELLULAR,-SLIGHT, MULTI-FOCAL
THYMUS <TH) : -ATROPHY,-MINIMAL
SPINAL CORD (SC) : -PIGMENT, NEURONAL,-SLIGHT
003497
APPENDIX 5 Individual Anatomic Pathology Data
Terminal Sacrifice
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS
Covance 6329-223 3M T-6295.7
PAGE: 54
ANIMAL NUMBER: 105550
SEX: FEMALE
DOSE GROUP: 2
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 02/26/99
STUDY DAY OF DEATH: 185
STUDY WEEK OF DEATH: 27
TERMINAL BODY WEIGHT: 2820.0 GRAMS
DATE AND TIME OF NECROPSY: 02/26/99 6:43
PROSECTOR: KEVIN BILLINGS
RECORDER: MICHELE ZIMA
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: ROBERT LEEDLE
WEIGHER: MICHELE ZIMA
NECROPSY
O B S E R V A T I O N S (CONTINUED)
HISTOPATHOLOGY
GENERAL INFORMATION (XX! : >NOTE:GALLBLADDER WEIGHT IS 0.6200 GRAMS BILE VOLUME IS 1.2000 ML
THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE! , MARROW, FEMUR (FM) , MARROW, STERNUM (SB), BONE, STERNUM (SB), EYE (EY) , BRAIN (BR) , KIDNEY (KD) , HEART (HT) , LIVER (LI), GALLBLADDER (GB) , SPLEEN (SP) , THYMUS (TH) , LN, MESENTERIC (MS), TRACHEA (TR) ,
ESOPHAGUS (ES), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), SALIV GL, MANDIB (SG) , MUSCLE, SKELETAL (SM) , SPINAL CORD (SC), NERVE. SCIATIC (SN) , STOMACH, GL (ST), DUODENUM (DU), PANCREAS (PA), JEJUNUM (JE) , ILEUM (IL) , CECUM (CE) , COLON (CO), RECTUM (RE), SKIN (SK) , MAMMARY, FEMALE (MF) , URINARY BLADDER (UB) , UTERUS (UT) , OVARY (OV) ,VAGINA (VA) , CERVIX (CV) , ADIPOSE TISSUE (AT), LN, TRACHEOBRON (TB) , LN, ANT MES/PANC (AP)
003498
APPENDIX 5 Individual Anatomic Pathology Data
Terminal Sacrifice
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS
Covance 6329-223 3M T-6295.7
PAGE: 55
ANIMAL NUMBER: 105532
SEX: FEMALE
DOSE GROUP: 3
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 02/25/99
STUDY DAY OF DEATH: 184
STUDY WEEK OF DEATH: 27
TERMINAL BODY WEIGHT: 2550.0 GRAMS
DATE AND TIME OF NECROPSY: 02/25/99 6:47
PROSECTOR: KEVIN BILLINGS
RECORDER: MICHELE ZIMA
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: ROBERT LEEDLE
WEIGHER: MICHELE ZIMA
ORGAN NAME
ABSOLUTE ORGAN WEIGHT (GRAMS)
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%)
ORGAN TO BRAIN WEIGHT RATIO
ORGAN STATUS
LEFT ADRENAL (ADO) RIGHT ADRENAL (ADI) BRAIN (BR) LF KIDNEY (KD0) RT KIDNEY (KD1) LIVER (LI) LF OVARY (OVO) RT OVARY (OV1) PANCREAS (PA) LF THYROID/PARA (TT0 ) RT THYROID/PARA (TT1 )
.3230 .2160 60.2360 5.0310 4.9920 58.3190 .0630 .0870 4.5080 .1150 .1020
.0127 % .0085 % 2.3622 % .1973 % .1958 % 2.2870 % .0025 % .0034 % .1768 % .0045 % .0040 %
.0054 .0036 1.0000 .0835 .0829 .9682 .0010 .0014 .0748 .0019 .0017
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
NECROPSY
OBSERVATIONS
HISTOPATHOLOGY
lu ng (LU) : -REP FOCUS(I)/AREA(S); ALL LOBES: MULTIPLE DARK RED PINPOINT FOCI
GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -EYES - DAVIDSONS
GENERAL INFORMATION (XX) : >NOTE:GALLBLADDER WEIGHT IS 0.4650 GRAMS BILE VOLUME IS 1.2000 ML
LUNG (LU) : >NOT REQUIRED TO BE EXAMINED FOR ANIMAL
THYMUS (TH) : -ATROPHY, -SEVERE
SPINAL CORD (SC) : -PIGMENT, NEURONAL,-MODERATE
003499
APPENDIX 5 Individual Anatomic Pathology Data
Terminal Sacrifice
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295> IN CYNOMOLGUS MONKEYS
Covance 6329-223 3M T-6295.7
PAGE: 56
ANIMAL NUMBER: 105532
SEX: FEMALE
DOSE GROUP: 3
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 02/25/99
STUDY DAY OF DEATH: 184
STUDY WEEK OF DEATH: 27
TERMINAL BODY WEIGHT: 2550.0 GRAMS
DATE AND TIME OF NECROPSY: 02/25/99 6:47
PROSECTOR: KEVIN BILLINGS
RECORDER: MICHELE ZIMA
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: ROBERT LEEDLE
WEIGHER: MICHELE ZIMA
THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR <FM) , MARROW, STERNUM (SE) , BONE, STERNUM (SB), EYE (EY) , BRAIN (BR) , KIDNEY (KD) , HEART (HT) , LIVER (LI), GALLBLADDER (GB), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), TRACHEA (TR) , ESOPHAGUS (ES), THYROID (TY) , PARATHYROID (PT) , ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , AORTA (AO), PITUITARY (PI), SALIV GL, MANDIB (SG) , MUSCLE, SKELETAL (SM! , SPINAL CORD (SC), NERVE, SCIATIC (SN), STOMACH, GL (ST), DUODENUM (DU), PANCREAS (PA), JEJUNUM (JE) , ILEUM (IL), CECUM (CE) , COLON (CO), RECTUM (RE), SKIN (SK), MAMMARY, FEMALE (MF) , URINARY BLADDER (UB) , UTERUS (UT) , OVARY (OV) , VAGINA (VA) , CERVIX (CV) , ADIPOSE TISSUE (AT), LN, TRACHEOBRON (TB) , LN, ANT MES/PANC (API
THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: LIVER (LI)
003500
APPENDIX 5 Individual Anatomic Pathology Data
Terminal Sacrifice
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295> IN CYNOMOLGUS MONKEYS
Covance 6329-223 3M T-6295.7
PAGE: 57
ANIMAL NUMBER: 105538
SEX: FEMALE
DOSE GROUP: 3
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 02/25/99
STUDY DAY OF DEATH: 184
STUDY WEEK OF DEATH: 27
TERMINAL BODY WEIGHT: 3200.0 GRAMS
DATE AND TIME OF NECROPSY: 02/25/99 10:25
PROSECTOR: STEVE VAN ADESTINE
RECORDER: TODD ACKER
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: ROBERT LEEDLE
WEIGHER: TODD ACKER
ORGAN NAME
ABSOLUTE ORGAN WEIGHT (GRAMS)
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%)
ORGAN TO BRAIN WEIGHT RATIO
ORGAN STATUS
LEFT ADRENAL (ADO) RIGHT ADRENAL (ADI) BRAIN (BR) LF KIDNEY (KD0) RT KIDNEY (KD1) LIVER (LI) LF OVARY (OV0) RT OVARY (OV1) PANCREAS (PA) LF THYROID/PARA (TT0) RT THYROID/PARA (TT1 )
.3850 .2630 55.6900 5.8390 5.3480 59.5780 .2420 .1690 4.8070 .1350 .1480
.0120 % .0082 % 1.7403 % .1825 % .1671 % 1.8618 % .0076 % .0053 % .1502 % .0042 % .0046 %
.0069 .0047 1.0000 .1048 .0960 1.0698 .0043 .0030 .0863 .0024 .0027
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
NECROPSY
OBSERVATIONS
HISTOPATHOLOGY
LUNG (LU) : -DARK FOCUS (I) /AREA (S) ; ALL LOBES, DIFFUSE: MULTIPLE BLACK PINPOINT FOCI
SPLEEN (SP) : -LIGHT FOCUS(I)/AREA(S); DIFFUSE: MULTIPLE GRAY AREAS, UP TO 1.2 X 0.7 CM
LUNG (LU) : >NOT REQUIRED TO BE EXAMINED FOR ANIMAL
LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL, MULTI-FOCAL
SPLEEN (SP) : >N0T REQUIRED TO BE EXAMINED FOR ANIMAL
THYMUS (TH) : -ATROPHY,-SLIGHT
SPINAL CORD (SC) : -PIGMENT, NEURONAL,-MINIMAL
CECUM (CE) : >NOT REQUIRED TO BE EXAMINED FOR ANIMAL
03501
APPENDIX 5 Individual Anatomic Pathology Data
Terminal Sacrifice
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS
Covance 6329-223 3M T-6295.7
PAGE: 58
ANIMAL NUMBER: 105538
SEX: FEMALE
DOSE GROUP: 3
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 02/25/99
STUDY DAY OF DEATH: 184
STUDY WEEK OF DEATH: 27
TERMINAL BODY WEIGHT: 3200.0 GRAMS
DATE AND TIME OF NECROPSY: 02/25/99 10:25
PROSECTOR: STEVE VAN ADESTINE
RECORDER: TODD ACKER
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: ROBERT LEEDLE
WEIGHER: TODD ACKER
NECROPSY
OBSERVATIONS
CECUM (CE) :
-RED FOCUS(I)/AREA(S); SEROSAL SURFACE: MULTIPLE DARK RED FOCI, UP TO 0.5 CM IN DIAMETER; COLLECTED ON ROUTINE SECTION
GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -EYES - DAVIDSONS
GENERAL INFORMATION (XX) :
>NOTE:GALLBLADDER WEIGHT IS 0.5060 GRAMS BILE VOLUME IS 1.6000 ML
(CONTINUED)
HISTOPATHOLOGY
THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY:
BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BONE, STERNUM (SB), EYE (EY) , BRAIN (BR) , KIDNEY (KD) , HEART (HT) , LIVER (LI), GALLBLADDER (GB) , THYMUS (TH) , LN, MESENTERIC (MS), TRACHEA (TR) , ESOPHAGUS (ES) , THYROID <TY), PARATHYROID (PT) , ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , AORTA (AO), PITUITARY (PI), SALIV GL, MANDIB (SG) , MUSCLE, SKELETAL (SM) , SPINAL CORD (SC), NERVE, SCIATIC (SN) , STOMACH, GL (ST),
DUODENUM (DU), PANCREAS (PA), JEJUNUM (JE) , ILEUM (IL) , COLON (CO), RECTUM (RE), SKIN (SK) , MAMMARY, FEMALE (MF) , URINARY BLADDER (UB) , UTERUS (UT) , OVARY (OV) , VAGINA (VA) , CERVIX (CV) , ADIPOSE TISSUE (AT), LN, TRACHEOBRON (TB) , LN, ANT MES/PANC (AP)
003502
APPENDIX 5 Individual Anatomic Pathology Data
Terminal Sacrifice
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS
Covane 6329-223 3M T-6295.7
PAGE: 59
ANIMAL NUMBER: 105545
SEX: FEMALE
DOSE GROUP: 3
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 02/25/99
STUDY DAY OF DEATH: 184
STUDY WEEK OF DEATH: 27
TERMINAL BODY WEIGHT: 2460.0 GRAMS
DATE AND TIME OF NECROPSY: 02/25/99 7:31
PROSECTOR: KEVIN BILLINGS
RECORDER: MICHELE ZIMA
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: ROBERT LEEDLE
WEIGHER: MICHELE ZIMA
ORGAN NAME
ABSOLUTE ORGAN WEIGHT (GRAMS)
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%)
ORGAN TO BRAIN WEIGHT RATIO
ORGAN STATUS
LEFT ADRENAL (ADO) RIGHT ADRENAL (ADI) BRAIN (BR)
LF KIDNEY (KDO) RT KIDNEY (KD1) LIVER (LI) LF OVARY (OVO) RT OVARY (OV1) PANCREAS (PA) LF THYROID/PARA (TTO ) RT THYROID/PARA (TT1 )
.2640 .2060 55.6590 5.4870 5.2040 52.4930 .2040 .1400 4.1150 .2030 .1190
.0107 % .0084 % 2.2626 .2230 % .2115 % 2.1339 % .0083 % .0057 % .1673 %
.0083 % .0048 %
.0047 .0037 1.0000
.0986 .0935 .9431 .0037
.0025 .0739 .0036 .0021
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
NECROPSY
OBSERVATIONS
HISTOPATHOLOGY
GENERAL COMMENT (GC) :
-BONE MARROW SMEAR TAKEN -EYES - DAVIDSONS -NO MACROSCOPIC LESIONS
LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL, MULTI-FOCAL -DEGENERATION/NECROSIS, HEPATOCELLULAR,-MINIMAL, MULTI-FOCAL
THYMUS (TH) : -CYST, -PRESENT -ATROPHY,-MINIMAL
SPINAL CORD (SC) :
-PIGMENT, NEURONAL,-MINIMAL
003503
APPENDIX 5 Individual Anatomic Pathology Data
Terminal Sacrifice
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS.-T-6295) IN CYNOMOLGUS MONKEYS
Covance 6329-223 3M T-6295.7
PAGE: 60
ANIMAL NUMBER: 105545
SEX: FEMALE
DOSE GROUP: 3
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 02/25/99
STUDY DAY OF DEATH: 184
STUDY WEEK OF DEATH: 27
TERMINAL BODY WEIGHT: 2460.0 GRAMS
DATE AND TIME OF NECROPSY: 02/25/99 7:31
PROSECTOR: KEVIN BILLINGS
RECORDER: MICHELE ZIMA
POST-FIX WEIGHER: NOT AVAILABLE
. PATHOLOGIST: ROBERT LEEDLE
WEIGHER: MICHELE ZIMA
NECROPSY
O B S E R V A T I O N S (CONTINUED)
HISTOPATHOLOGY
GENERAL INFORMATION (XX) :
>NOTE :GALLBLADDER WEIGHT IS 0.7210 GRAMS BILE VOLUME IS 1.4000 ML
THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BONE, STERNUM (SB), EYE (EY) , BRAIN (BR) , KIDNEY (KD) , LUNG (LU) , HEART (HT) , LIVER (LI), GALLBLADDER (GB) , SPLEEN (SP), THYMUS (TH) , LN, MESENTERIC (MS), TRACHEA (TR) ,
ESOPHAGUS (ES), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), SALIV GL, MANDIB (SG) , MUSCLE, SKELETAL (SM) , SPINAL CORD (SC), NERVE, SCIATIC (SN) , STOMACH, GL (ST), DUODENUM (DU), PANCREAS (PA), JEJUNUM (JE) , ILEUM (IL) ,CECUM (CE) , COLON (CO), RECTUM (RE), SKIN (SK), MAMMARY, FEMALE (MF) , URINARY BLADDER (UB) , UTERUS (UT) , OVARY(OV) , VAGINA (VA) , CERVIX (CV) , ADIPOSE TISSUE (AT) , LN, TRACHEOBRON (TB) , LN, ANT MES/PANC (AP)
003504
APPENDIX 5 Individual Anatomic Pathology Data
Terminal Sacrifice
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS
Covance 6329-223 3M T-6295.7
PAGE: 61
ANIMAL NUMBER: 105548
SEX: FEMALE
DOSE GROUP: 3
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 02/25/99
STUDY DAY OF DEATH: 184
STUDY WEEK OF DEATH: 27
TERMINAL BODY WEIGHT: 2865.0 GRAMS
DATE AND TIME OF NECROPSY: 02/25/99 11:00
PROSECTOR: STEVE VAN ADESTINE
RECORDER: TODD ACKER
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: ROBERT LEEDLE
WEIGHER: TODD ACKER
ORGAN NAME
ABSOLUTE ORGAN WEIGHT (GRAMS)
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%)
ORGAN TO BRAIN WEIGHT RATIO
ORGAN STATUS
LEFT ADRENAL (ADO) RIGHT ADRENAL (ADI) BRAIN (BR) LF KIDNEY (KD0) RT KIDNEY (KD1) LIVER (LI) LF OVARY (OVO)
RT OVARY (OV1) PANCREAS (PA) LF THYROID/PARA (TT0 ) RT THYROID/PARA (TT1 )
.3880 .2850 61.9790 6.0250 6.0670 57.7670 .2400 .1510 5.0690 .1640 .1640
.0135 % .0099 % 2.1633 % .2103 % .2118 %
2.0163 % .0084 % .0053 % .1769 % .0057 % .0057 %
.0063 .0046 1.0000 .0972 .0979 .9320 .0039 .0024 .0818 .0026 .0026
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
NECROPSY
OBSERVATIONS
HISTOPATHOLOGY
LUNG (LU) : -ADHESION (S) ; ADHERED TO PLEURA, DIAPHRAGM, PERICARDIUM, AND EACH OTHER: MULTIPLE GRAY, FIBROUS ADHESIONS; COLLECTED INTACT
CECUM (CE) : -RED FOCUS(I)/AREA(S); DIFFUSE: MULTIPLE DARK RED FOCI, UP TO 0.5 CM IN DIAMETER; COLLECTED ON ROUTINE SECTION
LUNG (LU) : >NOT REQUIRED TO BE EXAMINED FOR ANIMAL
LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MODERATE, FOCAL
THYMUS (TH) : -ATROPHY,-MODERATELY SEVERE
SPINAL CORD (SC) : -PIGMENT, NEURONAL,-SLIGHT
CECUM (CE) : >NOT REQUIRED TO BE EXAMINED FOR ANIMAL
003505
APPENDIX 5 Individual Anatomic Pathology Data
Terminal Sacrifice
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS.-T-6295) IN CYNOMOLGUS MONKEYS
Covance 6329-223 3M T-6295.7
PAGE: 62
ANIMAL NUMBER: 105548
SEX: FEMALE
DOSE GROUP: 3
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 02/25/99
STUDY DAY OF DEATH: 184
STUDY WEEK OF DEATH: 27
TERMINAL BODY WEIGHT: 2865.0 GRAMS
DATE AND TIME OF NECROPSY: 02/25/99 11:00
PROSECTOR: STEVE VAN ADESTINE
'
RECORDER: TODD ACKER
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: ROBERT LEEDLE
WEIGHER: TODD ACKER
NECROPSY
O B S E R V A T I O N S (CONTINUED)
HISTOPATHOLOGY
GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -EYES - DAVIDSONS
GENERAL INFORMATION (XX) :
>NOTE:GALLBLADDER WEIGHT IS 0.7810 GRAMS BILE VOLUME IS 2.6000 ML
THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BONE, STERNUM (SB), EYE (EY) , BRAIN (BR) , KIDNEY (KD) , HEART (HT) , LIVER (LI), GALLBLADDER (GB) , SPLEEN (SP), THYMUS (TH) , LN, MESENTERIC (MS), TRACHEA (TR) , ESOPHAGUS (ES), THYROID (TY) , PARATHYROID (PT) , ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , AORTA (AO),
PITUITARY (PI), SALIV GL, MANDIB (SG) , MUSCLE, SKELETAL (SMI, SPINAL CORD (SC), NERVE, SCIATIC (SN), STOMACH, GL (ST), DUODENUM (DO), PANCREAS (PA), JEJUNUM (JE) , ILEUM (IL) , COLON (CO), RECTUM (RE), SKIN (SK) , MAMMARY, FEMALE (MF) , URINARY BLADDER (UB) , UTERUS (UT) , OVARY (OV) , VAGINA (VA) , CERVIX (CV) , ADIPOSE TISSUE (AT), LN, TRACHEOBRON (TB) , LN, ANT MES/PANC (AP)
003506
APPENDIX 5 Individual Anatomie Pathology Data
Terminal Sacrifice
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS
Covance 6329-223 3M T-6295.7
PAGE: 62
ANIMAL NUMBER: 105534
SEX: FEMALE
DOSE GROUP: 4
SACRIFICE STATUS: SCHEDULED, TERMINAL iSACRIFICE
DATE OF DEATH: 02/26/99
STUDY DAY OF DEATH: 185
STUDY WEEK OF DEATH: 27
TERMINAL BODY WEIGHT : 2500.0 GRAMS
DATE AND TIME OF NECROPSY: 02/26/99 8:14
PROSECTOR: STEVE VAN ADESTINE
RECORDER: JOHN S . HALFORD
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: ROBERT LEEDLE
WEIGHER: JOHN S. HALFORD
ORGAN NAME
ABSOLUTE ORGAN WEIGHT (GRAMS)
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%)
ORGAN TO BRAIN WEIGHT RATIO
ORGAN STATUS
LEFT ADRENAL (ADO) RIGHT ADRENAL (ADI)
BRAIN (BR) LF KIDNEY (KD0) RT KIDNEY (KD1) LIVER (LI) LF OVARY (OVO)
RT OVARY (OV1) PANCREAS (PA) LF THYROID/PARA (TT0) RT THYROID/PARA (TT1) GALLBLADDER (GB) BILE(VOLUME) (BI)
.3290 .2270 54.3510 4.8280 4.9920 75.5500 .1600 .1480 4.4740 .1370 .1210 .5260 2.0000 mL
.0132 % .0091 % 2.1740 % .1931 % .1997 % 3.0220 % .0064 % .0059 % .1790 % .0055 % .0048 %
.0061 .0042 1.0000 .0888 .0918 1.3900 .0029 .0027 .0823 .0025 .0022
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
NECROPSY
OBSERVATIONS
HISTOPATHOLOGY
LUNG (LU) : -DARK FOCUS(I)/AREA(S); ALL LOBES: MULTIPLE DARK BROWN PINPOINT FOCI -LIGHT FOCUS (I)/AREA(S>j RIGHT AND LEFT CAUDAL LOBES: MULTIPLE TAN AREAS, UP TO 0.2 X 0.1 CM
BONE, FEMUR (FE) : -GROWTH PLATE OPEN,-MODERATE
KIDNEY (KD) : -MINERALIZATION, MEDULLA,-MINIMAL
LUNG (LU) : -HYPERPLASIA, LYMPHOCYTIC, PERIBRONCHIOLAR/PERIVASCULAR,MINIMAL -INFILTRATE, MACROPHAGE, ALVEOLAR,-MINIMAL
LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL, MULTI-FOCAL -HYPERTROPHY, HEPATOCELLULAR,-SLIGHT, DIFFUSE
o
CO
Co/T
<1
757
APPENDIX 5 Individual Anatomic Pathology Data
Terminal Sacrifice
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS
Covance 6329-223 3M T-6295.7
PAGE: 63
ANIMAL NUMBER: 105534
SEX: FEMALE
DOSE GROUP: 4
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 02/26/99
STUDY DAY OF DEATH: 185
STUDY WEEK OF DEATH: 27
TERMINAL BODY WEIGHT: 2500.0 GRAMS
DATE AND TIME OF NECROPSY: 02/26/99 8:14
PROSECTOR: STEVE VAN ADESTINE
RECORDER: JOHN S. HALFORD
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: ROBERT LEEDLE
WEIGHER: JOHN S. HALFORD
NECROPSY
O B S E R V A T I O N S (CONTINUED)
HISTOPATHOLOGY
ADRENAL, CORTEX (AC) : -DIFFUSELY DARK; BILATERAL: BROWN
CECUM (CE) : -DARK FOCUS(I)/AREA(S); SEROSAL SURFACE AND LUMEN, DIFFUSE: MULTIPLE DARK BROWN, SLIGHTLY RAISED AREAS, UP TO 0.5 X 0.2 CM; COLLECTED ON ROUTINE SECTION
COLON (CO) : -DARK FOCUS(I)/AREA(S); SEROSAL SURFACE AND LUMEN, DIFFUSE: MULTIPLE DARK BROWN, SLIGHTLY RAISED FOCI, UP TO 0.3 CM IN DIAMETER; COLLECTED ON ROUTINE SECTION
ADIPOSE TISSUE (AT) : -RAISED FOCUS (I)/AREA(S) ; MESENTERY, DIFFUSE: MULTIPLE TAN FOCI, UP TO 0.3 CM IN DIAMETER (CAP 29)
LIVER (LI) : -VACUOLATION, HEPATOCELLULAR,-SLIGHT, DIFFUSE
THYMUS (TH) : -ATROPHY,-MODERATE
TRACHEA (TR) : -INFILTRATE, LYMPHOHISTIOCYTIC,-SLIGHT
ADRENAL, CORTEX (AC) : UNREMARKABLE
DUODENUM (DU) : -INFILTRATE, MACROPHAGE, PIGMENTED,-MODERATE
JEJUNUM (JE) : -INFILTRATE, MACROPHAGE, PIGMENTED,-SLIGHT
ILEUM (IL) : -INFILTRATE, MACROPHAGE, PIGMENTED,-SLIGHT
CECUM (CE) : -PARASITISM,-PRESENT
COLON (CO) : -PARASITISM, INTRAMUSCULAR, -PRESENT
URINARY BLADDER (UB) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL
OVARY (OV) : -MINERALIZATION, -MINIMAL
ADIPOSE TISSUE (AT) : -LYMPHOID TISSUE,-PRESENT
O
CO
CA
00 758
APPENDIX 5 Individual Anatomie Pathology Data
Terminal Sacrifice
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS
Covance 6329-223 3M T-6295.7
PAGE: 64
ANIMAL NUMBER: 105534
SEX: FEMALE
DOSE GROUP: 4
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 02/26/99
STUDY DAY OF DEATH:1: 185
STUDY WEEK OF DEATH: 27
TERMINAL BODY WEIGHT: 2500.0 GRAMS
DATE AND TIME OF NECROPSY: 02/26/99 8:14
PROSECTOR: STEVE VAN ADESTINE
RECORDER: JOHN S. HALFORD
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: ROBERT LEEDLE
WEIGHER: JOHN S. HALFORD
NECROPSY
O B S E R V A T I O N S (CONTINUED)
HISTOPATHOLOGY
GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -EYES - DAVIDSONS
THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY:
BONE, FEMUR (FE) , MARROW. FEMUR (FM) , MARROW, STERNUM <SE) , BONE, STERNUM (SB), EYE (EY) , BRAIN (BR) , KIDNEY (KD) , HEART (HT), LIVER (LI), GALLBLADDER (GB), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), TRACHEA (TR), ESOPHAGUS (ES) , THYROID (TY) , PARATHYROID (PT) , ADRENAL, MEDULLA (MA) , AORTA (AO), PITUITARY (PI), SALIV GL, MANDIB (SG) , MUSCLE, SKELETAL (SM) , SPINAL CORD (SC), NERVE, SCIATIC (SN) , STOMACH, GL (ST), DUODENUM (DU) , PANCREAS (PA) , JEJUNUM (JE) , ILEUM (IL) , RECTUM (RE) , SKIN (SK) , MAMMARY, FEMALE (MF) , URINARY BLADDER (UB) , UTERUS (UT) , OVARY (OV) , VAGINA (VA) , CERVIX (CV) , LN, TRACHEOBRON (TB) , LN, ANT MES/PANC (AP)
THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION:
MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BONE, STERNUM (SB), EYE (EY) , BRAIN (BR) , HEART (HT) , GALLBLADDER (GB) , SPLEEN (SP), LN, MESENTERIC (MS), ESOPHAGUS (ES) , THYROID (TY) , PARATHYROID (PT) , ADRENAL, MEDULLA (MA) , AORTA (AO), PITUITARY (PI), SALIV GL, MANDIB (SG) , MUSCLE, SKELETAL (SM) , SPINAL CORD (SC), NERVE, SCIATIC (SN) , STOMACH, GL (ST), PANCREAS (PA), RECTUM (RE), SKIN (SK) , MAMMARY, FEMALE (MF) , UTERUS (UT) , VAGINA (VA) , CERVIX (CV)
003509
759
APPENDIX 5 Individual Anatomic Pathology Data
Terminal Sacrifice
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS
Covance 6329-223 3M T-6295.7
PAGE: 65
ANIMAL NUMBER: 105536
SEX: FEMALE
DOSE GROUP: 4
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 02/25/99
STUDY DAY OF DEATH: 184
STUDY WEEK OF DEATH: 27
TERMINAL BODY WEIGHT: 3185.0 GRAMS
DATE AND TIME OF NECROPSY: 02/25/99 9:56
PROSECTOR: STEVE VAN ADESTINE
RECORDER: TODD ACKER
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: ROBERT LEEDLE
WEIGHER: TODD ACKER
ORGAN NAME
ABSOLUTE ORGAN WEIGHT (GRAMS)
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%)
ORGAN TO BRAIN WEIGHT RATIO
ORGAN STATUS
LEFT ADRENAL (ADO) RIGHT ADRENAL (ADl)
BRAIN (BR) LF KIDNEY (KD0) RT KIDNEY (KD1)
LIVER (LI) LF OVARY (OVO) RT OVARY (OV1) PANCREAS (PA) LF THYROID/PARA (TT0) RT THYROID/PARA (TT1) GALLBLADDER (GB) BILE(VOLUME) (BI)
.3290 .2360 58.3990 6.9900 7.4110 93.8600 .1010
.1360 4.7900
.1910
.2400 .6650 2.6000 mL
.0103 % .0074 % 1.8336 %
.2195 % .2327 % 2.9469 % .0032 .0043 % .1504 .0060 % .0075
.0056 .0040
1.0000 .1197 .1269
1.6072 .0017
.0023 .0820 .0033 .0041
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
NECROPSY
OBSERVATIONS
HISTOPATHOLOGY
LUNG (LU) : -DARK FOCUS(I)/AREA(S); ALL LOBES, DIFFUSE: MULTIPLE PINPOINT BLACK FOCI
LIVER (LI) : -MOTTLED; ALL LOBES: BROWN AND TAN
MARROW, FEMUR (FM) : SECTION EXAMINED; TISSUE NOT PRESENT
BRAIN (BR) : -INFILTRATE, MACROPHAGES, PIGMENTED, PERIVASCULAR,-MINIMAL
LUNG (LU) : UNREMARKABLE
LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR,-MODERATE -VACUOLATION, HEPATOCELLULAR, CENTRILOBULAR,-MODERATELY SEVERE
oo
CO C/l
op 760
APPENDIX 5 Individual Anatomic Pathology Data
Terminal Sacrifice
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS
Covance 6329-223 3M T-6295.7
PAGE: 66
ANIMAL NUMBER: 105536
SEX: FEMALE
DOSE GROUP: 4
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 02/25/99
STUDY DAY OF DEATH: 184
STUDY WEEK OF DEATH: 27
TERMINAL BODY WEIGHT: 3185.0 GRAMS
DATE AND TIME OF NECROPSY: 02/25/99 9:56
PROSECTOR: STEVE VAN ADESTINE
RECORDER: TODD ACKER
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: ROBERT LEEDLE
WEIGHER: TODD ACKER
NECROPSY
O B S E R V A T I O N S (CONTINUED)
HISTOPATHOLOGY
ADRENAL, CORTEX (AC) : -DIFFUSELY DARK; BILATERAL: BROWN
GALLBLADDER (GB) : -INFILTRATE, LYMPHOHISTIOCYTIC, -MINIMAL
THYMUS (TH) -CYST,-PRESENT -ATROPHY,-MODERATELY SEVERE
TRACHEA (TR) : -INFILTRATE, LYMPHOHISTIOCYTIC,-SLIGHT
THYROID (TY) : -CYST, ULTIMOBRANCHIAL,-PRESENT
ADRENAL, CORTEX (AC) : -HYPERTROPHY, CORTICAL CELL,-MINIMAL -PIGMENT,-SLIGHT
SAL1V GL, MANDIB (SG) : -INFILTRATE, LYMPHOHISTIOCYTIC, -MINIMAL
SPINAL CORD (SC) : -PIGMENT, NEURONAL,-MODERATE
DUODENUM (DU) : -INFILTRATE, MACROPHAGE, PIGMENTED,-SLIGHT
JEJUNUM (JE) : -INFILTRATE, MACROPHAGE, PIGMENTED,-SLIGHT
ILEUM (IL) : -INFILTRATE, MACROPHAGE, PIGMENTED,-SLIGHT
CECUM (CE) :
-INFILTRATE, MACROPHAGE, PIGMENTED,-SLIGHT UTERUS (UT) :
-AMYLOID,-MODERATE OVARY (OV) :
-AMYLOID, -MODERATE -ONE EXAMINED,-PRESENT
003511
776611
APPENDIX 5 Individual Anatomic Pathology Data
Terminal Sacrifice
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS
Covance 6329-223 3M T-6295.7
PAGE: 67
ANIMAL NUMBER: 105536
SEX: FEMALE
DOSE GROUP: 4
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 02/25/99
STUDY DAY OF DEATH: 184
STUDY WEEK OF DEATH: 27
TERMINAL BODY WEIGHT: 3185.0 GRAMS
DATE AND TIME OF NECROPSY: 02/25/99 9:56
PROSECTOR: STEVE VAN ADESTINE
RECORDER: TODD ACKER
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: ROBERT LEEDLE
WEIGHER: TODD ACKER
NECROPSY
O B S E R V A T I O N S (CONTINUED)
HISTOPATHOLOGY
GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -EYES - DAVIDSONS
THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BONE, STERNUM (SB), EYE (EY) , BRAIN (BR) , KIDNEY (KD) , HEART (HT), GALLBLADDER (GB) , SPLEEN (SP) , THYMUS (TH) , LN, MESENTERIC (MS), TRACHEA (TR), ESOPHAGUS (ES) , THYROID (TY), PARATHYROID (PT) , ADRENAL, MEDULLA (MA) , AORTA (AO), PITUITARY (PI), SALIV GL, MANDIB (SG) , MUSCLE, SKELETAL (SM) , SPINAL CORD (SC), NERVE, SCIATIC (SN) , STOMACH, GL (ST), DUODENUM (DU), PANCREAS (PA), JEJUNUM (JE), ILEUM (IL) , CECUM (CE) , COLON (CO), RECTUM (RE), SKIN (SK) , MAMMARY, FEMALE (MF) , URINARY BLADDER (UB) , UTERUS (UT) , OVARY (OV) , VAGINA (VA) , CERVIX (CV) , ADIPOSE TISSUE (AT) , LN, TRACHEOBRON (TB) , LN, ANT MES/PANC (AP)
THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION:
BONE, FEMUR (FE) , MARROW, STERNUM (SE) , BONE, STERNUM (SB), EYE (EY) , KIDNEY (KD) , HEART (HT) , SPLEEN (SP) . LN, MESENTERIC (MS), ESOPHAGUS (ES) , PARATHYROID (PT) , ADRENAL, MEDULLA (MA) , AORTA (AO), PITUITARY (PI), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), STOMACH, GL (ST), PANCREAS (PA), COLON (CO), RECTUM (RE), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), VAGINA (VA), CERVIX (CV)
003512
762
APPENDIX 5 Individual Anatomic Pathology Data
Terminal Sacrifice
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS
Covance 6329-223 3M T-6295.7
PAGE: 68
ANIMAL NUMBER: 105540
SEX: FEMALE
DOSE GROUP: 4
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 02/26/99
STUDY DAY OF DEATH: 185
STUDY WEEK OF DEATH: 27
TERMINAL BODY WEIGHT: 2700..0 GRAMS
DATE AND TIME OF NECROPSY: 02/26/99 10:20
PROSECTOR:: STEVE VAN ADESTINE
RECORDER: JOHN S. HALFORD
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: ROBERT LEEDLE
WEIGHER: JOHN S. HALFORD
ORGAN NAME
ABSOLUTE ORGAN WEIGHT (GRAMS)
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%)
ORGAN TO BRAIN WEIGHT RATIO
ORGAN STATUS
LEFT ADRENAL (ADO) RIGHT ADRENAL (ADI) BRAIN (BR) LF KIDNEY (KDO) RT KIDNEY (KD1) LIVER (LI) LF OVARY (OV0) RT OVARY (OVl) PANCREAS (PA) LF THYROID/PARA (TTO) RT THYROID/PARA (TT1) GALLBLADDER (GB) BILE(VOLUME) (BI)
.3440 .2550 56.3190 5.2090 4.8440 63.0760 .1400 .1410 4.4510 .2480 .2540 .5650 1.6000 mL
.0127 % .0094 %
2.0859 % .1929 % .1794 %
2.3361 % .0052 % .0052 % .1649 % .0092 % .0094 %
.0061 .0045 1.0000 .0925 .0860 1.1200 .0025 .0025 .0790 .0044 .0045
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
NECROPSY
OBSERVATIONS
HISTOPATHOLOGY
LUNG (LU) : -RED FOCUS (I) /AREA(S) ; RIGHT CAUDAL AND APICAL LOBES
MULTIPLE DARK RED INDISTINCT AREAS
MARROW, FEMUR (FM) : >SECTION EXAMINED; TISSUE NOT PRESENT
BRAIN (BR) : -INFILTRATE, MACROPHAGES, PIGMENTED, PERIVASCULAR,-SLIGHT
LUNG (LU) : -HEMORRHAGE,-MODERATE
LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL, MULTI-FOCAL -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR,-SLIGHT
THYMUS (TH) : -CYST,-PRESENT
003513
763
APPENDIX 5 Individual Anatomic Pathology Data
Terminal Sacrifice
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS
Covance 6329-223 3M T-6295.7
PAGE: 69
ANIMAL NUMBER: 105540
SEX: FEMALE
DOSE GROUP: 4
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 02/26/99
STUDY DAY OF DEATH: 185
STUDY WEEK OF DEATH: 27
TERMINAL BODY WEIGHT: 2700.0 GRAMS
DATE AND TIME OF NECROPSY: 02/26/99 10:20
PROSECTOR: STEVE VAN ADESTINE
RECORDER: JOHN S. HALFORD
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: ROBERT LEEDLE
WEIGHER: JOHN S. HALFORD
NECROPSY
O B S E R V A T I O N S (CONTINUED)
HISTOPATHOLOGY
SKIN (SK) : -ALOPECIA-FOCAL; RIGHT DORSAL THORACIC REGION: 0.3 X 2.5 CM (CAP 29)
GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -EYES - DAVIDSONS
THYMUS (TH) : -ATROPHY,-SLIGHT
TRACHEA (TR) :
-INFILTRATE, LYMPHOHISTIOCYTIC, -MINIMAL THYROID (TY) :
-CYST, ULTIMOBRANCHIAL,-PRESENT AORTA (AO) :
-PROLIFERATION, INTIMAL,-MODERATE MUSCLE, SKELETAL (SM) :
-INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL DUODENUM (DU) :
-INFILTRATE, MACROPHAGE, PIGMENTED,-SLIGHT SKIN (SK) :
-HAIR FOLLICLES, DECREASED,-MODERATE
003514
764
APPENDIX 5 Individual Anatomic Pathology Data
Terminal Sacrifice
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS
Covance 6329-223 3M T-6295.7
PAGE: 70
ANIMAL NUMBER: 105540
SEX: FEMALE
DOSE GROUP: 4
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 02/26/99
STUDY DAY OF DEATH: 185
STUDY WEEK OF DEATH: 27
TERMINAL BODY WEIGHT: 2700.0 GRAMS
DATE AND TIME OF NECROPSY: 02/26/99 10:20
PROSECTOR: STEVE VAN ADESTINE
RECORDER: JOHN S. HALFORD
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: ROBERT LEEDLE
WEIGHER: JOHN S. HALFORD
THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BONE, STERNUM (SB), EYE (EY) , BRAIN (BR) , KIDNEY (KD) ,
HEART (HT), LIVER (LI), GALLBLADDER (GB) , SPLEEN (SP) , THYMUS (TH) , LN, MESENTERIC (MS), TRACHEA (TR) , ESOPHAGUS (ES), THYROID (TY) , PARATHYROID (PT) , ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , AORTA (AO), PITUITARY (PI), SALIV GL, MANDIB (SG), MUSCLE, SKELETAL (SM), SPINAL CORD (SC), NERVE, SCIATIC (SN),
STOMACH, GL (ST), DUODENUM (DU), PANCREAS (PA), JEJUNUM (JE) , ILEUM (IL) , CECUM (CE) , COLON (CO), RECTUM (RE), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), OVARY (OV), VAGINA (VA), CERVIX (CV), ADIPOSE TISSUE (AT), LN, TRACHEOBRON (TB), LN, ANT MES/PANC (AP)
THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE) , MARROW, STERNUM (SE) , BONE, STERNUM (SB), EYE (EY) , KIDNEY (KD) , HEART (HT) , GALLBLADDER (GB) , SPLEEN (SP), LN, MESENTERIC (MS), ESOPHAGUS (ES) , PARATHYROID (PT) , ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , PITUITARY (PI), SALIV GL, MANDIB (SG) , SPINAL CORD (SC), NERVE, SCIATIC (SN) , STOMACH, GL (ST), PANCREAS (PA), JEJUNUM (JE) , ILEUM (IL) , CECUM (CE) , COLON (CO), RECTUM (RE), MAMMARY, FEMALE (MF), URINARY BLADDER (UB) , UTERUS (UT), OVARY (OV), VAGINA (VA), CERVIX (CV)
G 03515
765
APPENDIX 5 Individual Anatomic Pathology Data
Terminal Sacrifice
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS
Covance 6329-223 3M T-6295.7
PAGE: 71
ANIMAL NUMBER: 105551
SEX: FEMALE
DOSE GROUP: 4
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 02/26/99
STUDY DAY OF DEATH:: 185
STUDY WEEK OF DEATH: 27
TERMINAL BODY WEIGHT : 2230..0 GRAMS
DATE AND TIME OF NECROPSY: 02/26/99 7:43
PROSECTOR:: KEVIN BILLINGS
RECORDER: MICHELE ZIMA
POST--FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: ROBERT LEEDLE
WEIGHER: MICHELE ZIMA
ORGAN NAME
ABSOLUTE ORGAN WEIGHT (GRAMS)
ORGAN WEIGHT RELATIVE TO BODY WEIGHT (%)
ORGAN TO BRAIN WEIGHT RATIO
ORGAN STATUS
LEFT ADRENAL (ADO) RIGHT ADRENAL (ADI)
BRAIN (BR) LF KIDNEY (KDO) RT KIDNEY (KD1) LIVER (LI) LF OVARY (OVO) RT OVARY (OV1) PANCREAS (PA) LF THYROID/PARA (TTO) RT THYROID/PARA (TT1) GALLBLADDER (GB) BILE(VOLUME) (BI)
.3850 .2960 59.3140 6.0280 5.9040 68.7130 .2350 .1740 3.7750 .1730 .1630 .6040 1.8000 mL
.0173 % .0133 %
2.6598 % .2703 .2648 %
3.0813 % .0105 % .0078 % .1693 .0078 % .0073 %
.0065 .0050
1.0000 .1016 .0995
1.1585 .0040
.0029 .0636 .0029 .0027
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN WEIGHT TAKEN
NECROPSY
OBSERVATIONS
HISTOPATHOLOGY
LUNG (LU) : -RED FOCUS (I)/AREA(S); ALL LOBES: MULTIPLE DARK RED FOCI, PINPOINT AND UP TO 1 MM IN DIAMETER
MARROW, FEMUR (FM) : SECTION EXAMINED; TISSUE NOT PRESENT
BRAIN (BR) : -INFLAMMATION, LYMPHOHISTIOCYTIC,-MINIMAL
KIDNEY (KD) : -MINERALIZATION, MEDULLA, -MINIMAL
LUNG (LU) : UNREMARKABLE
LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL, MULTI-FOCAL -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR,-SLIGHT
003516
766
APPENDIX 5 Individual Anatomic Pathology Data
Terminal Sacrifice
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS
Covance 6329-223 3M T-6295.7
PAGE: 72
ANIMAL NUMBER: 105551
SEX: FEMALE
DOSE GROUP: 4
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 02/26/99
STUDY DAY OF DEATH: 185
STUDY WEEK OF DEATH: 27
TERMINAL BODY WEIGHT: 2230.0 GRAMS
DATE AND TIME OF NECROPSY: 02/26/99 7:43
PROSECTOR: KEVIN BILLINGS
RECORDER: MICHELE ZIMA
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: ROBERT LEEDLE
WEIGHER: MICHELE ZIMA
NECROPSY
O B S E R V A T I O N S (CONTINUED)
HISTOPATHOLOGY
SKIN (SK) : -ALOPECIA-DIFFUSE; ALL FOUR LIMBS: HAIRCOAT THIN; COLLECTED
GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -EYES - DAVIDSONS
GENERAL INFORMATION (XX) : >NOTE :>ANIMAL APPEARS TO BE IN ESTROUS
GALLBLADDER (GB) :
-INFILTRATE, LYMPHOHISTIOCYTIC, -MINIMAL TRACHEA (TR) :
-INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL THYROID (TY) :
-INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL SALIV GL, MANDIB (SG) :
-INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL MUSCLE, SKELETAL (SM) :
-PARASITES, CYST,-PRESENT SPINAL CORD (SC) :
-PIGMENT, NEURONAL,-MODERATE JEJUNUM (JE) :
-INFILTRATE, MACROPHAGE, PIGMENTED,-SLIGHT SKIN (SK) :
-HAIR FOLLICLES, DECREASED,-SLIGHT
003517
767
APPENDIX 5 Individual Anatomic Pathology Data
Terminal Sacrifice
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS
Covance 6329-223 3M T-6295.7
PAGE: 73
ANIMAL NUMBER: 105551
SEX: FEMALE
DOSE GROUP: 4
SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE
DATE OF DEATH: 02/26/99
STUDY DAY OF DEATH: 185
STUDY WEEK OF DEATH: 27
TERMINAL BODY WEIGHT: 2230.0 GRAMS
DATE AND TIME OF NECROPSY: 02/26/99 7:43
PROSECTOR: KEVIN BILLINGS
RECORDER: MICHELE ZIMA
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: ROBERT LEEDLE
WEIGHER: MICHELE ZIMA
THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE) , BONE, STERNUM (SB), EYE (EY) , BRAIN (BR) , KIDNEY (KD) , HEART (HT), LIVER (LI), GALLBLADDER (GB), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), TRACHEA (TR), ESOPHAGUS (ES), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), SALIV GL, MANDIB (SG) , MUSCLE, SKELETAL (SM) , SPINAL CORD (SC), NERVE, SCIATIC (SN) , STOMACH, GL (ST), DUODENUM (DU), PANCREAS (PA), JEJUNUM (JE) , ILEUM (IL) , CECUM (CE) , COLON (CO), RECTUM (RE), MAMMARY, FEMALE (MF) , URINARY BLADDER (UB) , UTERUS (UT) , OVARY (OV) , VAGINA (VA) , CERVIX (CV) , ADIPOSE TISSUE (AT) , LN, TRACHEOBRON (TB) , LN, ANT MES/PANC (AP)
THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE) , MARROW, STERNUM (SE) , BONE, STERNUM (SB), EYE (EY) , HEART (HT) , SPLEEN (SP) , THYMUS (TH) , LN, MESENTERIC (MS) , ESOPHAGUS (ES) , PARATHYROID (PT) . ADRENAL, CORTEX (AC) , ADRENAL, MEDULLA (MA) , AORTA (AO) , PITUITARY (PI), NERVE, SCIATIC (SN), STOMACH, GL (ST), DUODENUM (DU), PANCREAS (PA), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), OVARY (OV), VAGINA (VA), CERVIX (CV)
003518
768
APPENDIX 5 Individual Anatomic Pathology Data
Recovery Sacrifice
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT !PFOS;T-6295) IN CYNOMOLGUS MONKEYS
Covance 6329-223 3M T-6295.7
PAGE : 1
ANIMAL NUMBER: 105511
SEX: MALE
DOSE GROUP: 4
SACRIFICE STATUS: SCHEDULED, FIRST POST-RECOV SAC
DATE OF DEATH: 02/25/00
STUDY DAY OF DEATH: 549
STUDY WEEK OF DEATH: 79
TERMINAL BODY WEIGHT: 4240.0 GRAMS
DATE AND TIME OF NECROPSY: 02/25/00 7:56
PROSECTOR: KEVIN BILLINGS
RECORDER: MICHELE 2IMA
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: AS ASSIGNED
WEIGHER: MICHELE ZIMA
*** ORGAN WEIGHTS WERE NOT RECORDED ***
NECROPSY
OBSERVATIONS
HISTOPATHOLOGY
GENERAL COMMENT (GC) : -NO MACROSCOPIC LESIONS
LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC.-SLIGHT
THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY:
LIVER (LI), BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), KIDNEY (KD), LUNG (LU), HEART (HT) , GALLBLADDER (GB) , SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), TRACHEA (TR) , ESOPHAGUS (ES), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), SALIV GL, MANDIB (SG) , MUSCLE, SKELETAL (SM) , SPINAL CORD (SC), NERVE, SCIATIC (SN) , STOMACH, GL (ST), DUODENUM (DU), PANCREAS (PA), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), SKIN (SK), MAMMARY, MALE (MM), URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESICLES (SV) , EPIDIDYMIDES (EP), TESTIS (TE), CAVITY, THORACIC (TA)
THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: LIVER, BIOPSY (LI0)
003519
APPENDIX 5 Individual Anatomic Pathology Data
Recovery Sacrifice
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTAHE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOHOLGUS MONKEYS
Covance 6329-223 3M T-6295.7
PAGE: 2
ANIMAL NUMBER: 105522
SEX: MALE
DOSE GROUP: 4
SACRIFICE STATUS: SCHEDULED, FIRST POST-RECOV SAC
DATE OF DEATH: 02/25/00
STUDY DAY OF DEATH: 549
STUDY WEEK OF DEATH: 79
TERMINAL BODY WEIGHT: 4350.0 GRAMS
DATE AND TIME OF NECROPSY: 02/25/00 8:35
PROSECTOR: KEVIN BILLINGS
RECORDER: MICHELE ZIMA
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: AS ASSIGNED
WEIGHER: MICHELE ZIMA
`** ORGAN WEIGHTS WERE NOT RECORDED ***
NECROPSY
OBSERVATIONS
HISTOPATHOLOGY
LUNG (LU) : -ADHESION( S ) ; ALL LOBES TO EACH OTHER, PLEURA, PERICARDIAL SAC AND CAUDAL LOBES TO DIAPHRAGM: MULTIPLE TAN FIBROUS ADHESIONS
CAVITY, THORACIC (TA) : -NODULE(S); WITHIN ADHESIONS: MULTIPLE TAN AND FIRM NODULES, UP TO 0.3 CM IN DIAMETER
LIVER, BIOPSY (LI0) :
-PIGMENT, HEPATOCELLULAR,-SLIGHT LIVER (LI) :
-INFILTRATE, LYMPHOHISTIOCY'TIC,-MODERATE -PIGMENT, HEPATOCELLULAR,-SLIGHT -HYPERPLASIA, BILE DUCT,-MODERATE -INFLAMMATION, EOSINOPHILIC, PERI-BILE DUCT,-MODERATE LUNG (LU) : >NOT REQUIRED TO BE EXAMINED FOR ANIMAL
THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY:
LIVER (LI), BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), KIDNEY (KD) , HEART (HT) , GALLBLADDER (GB) , SPLEEN (SP) , THYMUS (TH) , LN, MESENTERIC (MS), TRACHEA (TR) , ESOPHAGUS (ES) , THYROID (TY), PARATHYROID (PT) , ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA) , AORTA (AO), PITUITARY (PI), SALIV GL, MANDIB (SG), MUSCLE, SKELETAL (SM), SPINAL CORD (SC), NERVE, SCIATIC (SN), STOMACH, GL (ST), DUODENUM (DU), PANCREAS (PA), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), SKIN (SK) , MAMMARY, MALE (MM), URINARY BLADDER (UB) , PROSTATE (PR), SEMINAL VESICLES (SV), EPIDIDYMIDES (EP) , TESTIS (TE), GENERAL COMMENT (GC)
APPENDIX 5 Individual Anatomic Pathology Data
Recovery Sacrifice
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS
Covance 6329-223 3M T-6295.7
PAGE: 3
ANIMAL NUMBER: 105533
SEX: FEMALE
DOSE GROUP: 4
SACRIFICE STATUS: SCHEDULED, FIRST POST-RECOV SAC
DATE OF DEATH: 02/25/00
STUDY DAY OF DEATH: 549
STUDY WEEK OF DEATH: 79
TERMINAL BODY WEIGHT: 2535.0 GRAMS
DATE AND TIME OF NECROPSY: 02/25/00 8:58
PROSECTOR: KEVIN BILLINGS
RECORDER: MICHELE ZIMA
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: AS ASSIGNED
WEIGHER: MICHELE ZIMA
*** ORGAN WEIGHTS WERE NOT RECORDED ***
NECROPSY
OBSERVATIONS
HISTOPATHOLOGY
LIVER (LI) : -ADHESION(S) ; DIAPHRAGMATIC SURFACE OF RIGHT MEDIAN LOBE TO DIAPHRAGM: SINGLE TAN, FIBROUS LINEAR. AREA, 2.0 CM IN LENGTH
GALLBLADDER (GB) : >NOTE :>NO BILE AVAILABLE FOR SPECIAL PROCEDURE
LIVER (LI) : -FIBROSIS, CAPSULAR,-SLIGHT
GALLBLADDER (GB) : >NOT REQUIRED TO BE EXAMINED FOR ANIMAL
THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY:
BONE, FEMUR (FE) , MARROW, FEMUR (FM) , MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY) , BRAIN (BP.), KIDNEY (KD) , LUNG (LU), HEART (HT), GALLBLADDER (GB), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), TRACHEA (TR), ESOPHAGUS (ES), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), SALIV GL, MANDIB (SG), MUSCLE, SKELETAL (SM) , SPINAL CORD (SC), NERVE, SCIATIC (SN), STOMACH, GL (ST), DUODENUM (DU), PANCREAS (PA), JEJUNUM (JE) , ILEUM (IL), CECUM (CE) , COLON (CO), RECTUM (RE), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), OVARY (OV),VAGINA (VA), CERVIX (CV), GENERAL COMMENT (GC), CAVITY, THORACIC (TA)
THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: LIVER, BIOPSY (LI0)
003521
APPENDIX 5 Individual Anatomic Pathology Data
Recovery Sacrifice
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS
Covance G329-223 3M T-6295.7
PAGE: 4
ANIMAL NUMBER: 105542
SEX: FEMALE
DOSE GROUP: 4
SACRIFICE STATUS: SCHEDULED, FIRST POST-RECOV SAC
DATE OF DEATH: 02/25/00
STUDY DAY OF DEATH: 549
STUDY WEEK OF DEATH: 79
TERMINAL BODY WEIGHT: 3705.0 GRAMS
DATE AND TIME OF NECROPSY: 02/25/00 9:23
PROSECTOR: KEVIN BILLINGS
RECORDER: MICHELE ZIMA
POST-FIX WEIGHER: NOT AVAILABLE
PATHOLOGIST: AS ASSIGNED
WEIGHER: MICHELE ZIMA
*** ORGAN WEIGHTS WERE NOT RECORDED ***
NECROPSY
OBSERVATIONS
HISTOPATHOLOGY
GENERAL COMMENT (GC) : -NO MACROSCOPIC LESIONS
LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL
THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY:
LIVER (LI), BONE, FEMUR (FE) , MARROW. FEMUR IFM) , MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY) , BRAIN (BR) , KIDNEY (KD), LUNG (LU), HEART (HT), GALLBLADDER (GB), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), TRACHEA (TR), ESOPHAGUS (ES), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), SALIV GL, MANDIB (SG) , MUSCLE, SKELETAL (SM) , SPINAL CORD (SC), NERVE, SCIATIC (SH) , STOMACH, GL (ST), DUODENUM (DU), PANCREAS (PA), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), OVARY (OV),VAGINA (VA), CERVIX (CV), CAVITY, THORACIC (TA)
THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: LIVER, BIOPSY (LI0)
003522
APPENDIX 6
Covance 6329-223 3M T-6295.7
Summary and Individual Blood Hormone Determination
Note: This appendix contains information supplied by Ani Lytics Inc.
003523
769
ANIMAL NUMBER
CORTISOL //g/dL
Appendix 6
Summary and Individual Blood Hormone Determination Day -50
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS
TESTOSTERONE ng/mL
ESTRADIOL pg/mL
ESTRONE pg/mL
ESTRIOL pg/mL
THYROID STIMULATING //U/mL
TOTAL TRIIODOTHYRONINE
ng/dL
Covance 6329-223 3M T-6295.7
TOTAL THYROXIN
ftg/dL
Group : Male 1 Dose Level : 0
105508 105517 105519 105520 105526 105527
54.69 49.55 64.74 47.30 60.37
50.69
14.54 3.04 6.12
10.74 0.09 6.48
MEAN S.D. N
54.56 6.785 6
6.84 5.199 6
Group: Male 2 Dose Level: 0.03
105514 105515 105516 105521
71.04 38.63 58.36 58.05
1.18 9.81 0.34 14.26
MEAN S.D. N
56.52 13.374
4
6.40 6.767 4
Group: Male 3 Dose Level: 0.15
105505 105510 105518 105523 105524 105528
48.00 38.05 50.92 56.98 62.46 63.18
3.04 0.41 3.77 4.38 1.02 0.97
MEAN S.D. N
53.27 9.606 6
2.27 1.674 6
Dosage Unit: mg/kg/day
29.48 51.76 31.21 30.92 31.69 43.40
20.01 54.86 17.51 39.76 27.63 24.47
0.00 0.00 0.00 0.00 0.00 0.00
36.41 9.077
6
30.71
14.158 6
0.00 0.000 6
Dosage Unit: mg/kg/day
38.90 27.91 32.30 59.78
51.37 17.75 29.41 62.35
0.00 0.00 0.00 0.00
39.72 14.114
4
40.22 20.296
4
0.00 0.000 4
Dosage Unit: mg/kg/day
43.24 23.74 53.56 43.26 30.26 26.50
30.43 26.96 28.80 39.35 26.55 18.67
0.00 0.00 0.00 0.00 0.00 0.00
36.76 11.692
6
28.46 6.698 6
0.00 0.000 6
0.44 0.98 0.92 2.11 0.86 3.34
1.44 1.084 6
1.44 1.04 1.13 1.45
1.27 0.211 4
1.20 0.60 1.67 0.00 0.62 1,04
0.86 0.578 6
89.59 125.67
82.21 122.59 132.25 102.72
109.17 20.673 6
133.26 83.16
138.37 130.08
121.22 25.600 4
122.64 115.95 124.80 162.12 117.52 113.68
126.12 18.122 6
4.96 3.25 5.11 3.13 3.80 3.52
3.96 0.864 6
6.14 3.32 8.91 4.56
5.73 2.412 4
5.60 3.48 4.29 6.48 4.28 4.49
4.77 1.079 6
003524
770
ANIMAL NUMBER
CORTISOL //g/dL
Appendix 6
Summary and Individual Blood Hormone Determination Day -50
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS
TESTOSTERONE ng/mL
ESTRADIOL pg/mL
ESTRONE pg/mL
ESTRIOL pg/mL
THYROID STIMULATING JAJ/mL
TOTAL TRIIODOTHYRONINE
ng/dL
Covance 6329-223 3M T-6295.7
TOTAL THYROXIN
//g/dL
Group: Male 4 Dose Level: 0.75
105506 105507 105509 105511 105512 105522
46.92 41.20 65.60 48.27 49.15 44.81
3.31 21.45
2.21 18.86
0.29 12.56
MEAN S.D. N
49.33 8.464 6
9.78 9.117 6
Group: Female 1 Dose Level: 0
105529 105530 105531 105535 105544 105549
68.63 64.90 55.89 51.86 55.61 52.20
0.49 0.03 0.36 0.38 0.38 0.04
MEAN S.D. N
58.18 6.956 6
0.28 0.195 6
Group : Female 2 Dose Level : 0.03
105537 105541 105547 105550
73.24 82.66 71.82 46.90
0.19 0.66 0.16 0.29
MEAN S.D. N
68.66 15.280
4
0.33 0.230 4
Dosage Unit: mg/kg/day
26.45 49.83 30.80 32.75 38.12 49.93
29.18 33.79 24.47 46.01 22.90 48.77
0.00 0.00 0.00 0.00 0.00 0.00
37.98 9.951 6
34.19 10.950
6
0.00 0.000 6
Dosage Unit: mg/kg/day
48.75 48.53 53.05 50.13 37.23 50.33
38.12 32.43 61.53 31.55 26.87 27.55
0.00 0.00 0.00 0.00 0.00 0.00
48.0 5.519 6
36.34 12.984
6
0.00 0.000 6
Dosage Unit: mg/kg/day
91.05 60.36 55.87 50.49
129.22 42.73 39.96 46.09
0.00 0.00
0.00 0.00
64.44 18.191
4
64.50 43.219
4
0.00 0.000 4
0.08 1.45 1.81 0.42 0.60 1.66
1.00 0.726 6
0.75 0.74 0.30 1.14 2.67 0.69
1.05 0.838 6
0.00 0.65 0.79 0.88
0.58 0.398
4
148.18 113.67 112.11 152.20 162.79 151.90
140.14 21.669 6
91.26 153.02
45.26 128.93
96.13 87.95
100.43 37.095 6
158.33 140.97 115.35 107.01
130.42 23.561
4
4.90 4.66 5.14 4.13 4.63 3.36
4.47 0.639 6
5.25 8.79 16.59 3.80 4.13 4.43
7.17 4.963 6
6.80 6.99 4.66 4.27
5.68 1.414
4
003525
771
ANIMAL NUMBER
CORTISOL //g/dL
Appendix 6
Summary and Individual Blood Hormone Determination Day -50
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS
TESTOSTERONE ng/mL
ESTRADIOL pg/mL
ESTRONE pg/mL
ESTRIOL pg/mL
THYROID STIMULATING /AJ/mL
TOTAL TRIIODOTHYRONINE
ng/dL
Covance 6329-223 3M T-6295.7
TOTAL THYROXIN
/ig/dL
Group : Female 3 Dose Level: 0.15
105532 105538 105539 105545 105548 105552
56.59 51.32 66.59 63.69 65.26 49.09
0.13 0.23 0.34 0.25 0.45 0.33
MEAN S.D. N
58.76 7.502 6
0.29 0.110 6
Group: Female 4 Dose Level: 0.75
105533 105534 105536 105540 105542 105551
58.99 59.49 51.68 46.17
87.39 67.04
0.35 0.05 0.29 0.15 0.63 0.38
MEAN S.D. N
61.79 14.438
6
0.31 0.201 6
Dosage Unit: mg/kg/day
51.67 52.69 129.12 176.45 63.53 23.32
35.53 35.81 82.62 132.50 47.80 15.96
0.00 0.00 0.00 0.00 0.00 0.00
82.80 57.794
6
58.37 42.484
6
0.00 0.000 6
Dosage Unit: mg/kg/day
96.99 42.90 47.76 54.58 39.07
86.86
64.39 34.98 46.31 88.38 31.81 107.99
0.00 0.00 0.00 0.00 0.00 0.00
61.36 24.447
6
62.31 30.672
6
0.00 0.000 6
4.46 0.00 1.48 0.67 0.00 1.52
1.36 1.663 6
2.10 0.98 0.17 1.51 0.32 0.21
0.88 0.795 6
64.50 137.04 117.92 135.57 104.23
71.94
105.20 31.182 6
101.63 97.38
124.27 126.16 109.29
95.16
108.98 13.480 6
5.49 3.21 5.68 5.05 4.24 6.35
5.00 1.123 6
4.25 4.94 5.78 5.23 6.44 5.78
5.40 0.766 6
003526
772
ANIMAL NUMBER
CORTISOL pg/dL
Appendix 6
Summary and Individual Blood Hormone Determination Day -40
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT <PFOS;T-6295) IN CYNOMOLGUS MONKEYS
TESTOSTERONE ng/mL
ESTRADIOL pg/mL
ESTRONE pg/mL
ESTRIOL pg/mL
THYROID STIMULATING //u/mL
TOTAL TRIIODOTHYRONINE
ng/dL
Covance 6329-223 3M T-6295.7
TOTAL THYROXIN
/ig/dL
Group: Male 1 Dose Level : 0
105508 105517 105519 105520 105526 105527
57.43 43.65 71.52 52.42 84.79 79.36
3.30 2.35 0.37
11.10 0.21 5.72
MEAN S.D. N
64.86 16.197
6
3.84 4.098 6
Group : Male 2 Dose Level: 0.03
105514 105515 105516 105521
79.55 67.38 87.16 62.83
1.10 5.86 0.19 9.82
MEAN S.D. N
74.23 11.141
4
4.24 4.473 4
Group: Male 3 Dose Level: 0.15
105505 105510 105518 105523 105524 105528
50.93 77.83 67.52 61.48 63.60 72.30
4.07 0.53 0.93 1.81 0.68 6.04
MEAN S.D. N
65.61 9.320 6
2.34 2.235 6
Dosage Unit: mg/kg/day
23.93 42.46 32.19 46.29 26.36 33.96
11.61 29.34 19.63 35.48 20.87 34.93
0.00 0.00 0.00 0.00 0.00 0.00
34.20 8.780 6
25.31 9.507 6
0.00 0.000 6
Dosage Unit: mg/kg/day
35.50 21.00 23.13 63.80
4.64 28.82 23.58 49.29
0.00 0.00 0.00 0.00
35.86 19.695
4
26.58 18.359
4
0.00 0.000 4
Dosage Unit: mg/kg/day
45.97 31.51 45.46 34.64 31.45 28.17
18.34 17.29 25.93 27.49 16.37 13.10
0.00 0.00 0.00 0.00 0.00 0.00
36.20 7.651 6
19.75 5.688 6
0.00 0.000 6
0.26 0.50 0.56 0.34 1.13 0.95
0.62 0.345 6
1.16 0.21 0.94 1.12
0.86 0.442 4
0.85 0.69 1.87 0.00 0.75 0.00
0.69 0.689 6
113.08 104.32 122.61 137.32 154.19
99.03
121.76 20.932 6
140.65 97.32
127.13 120.13
121.31 18.118 4
130.66 104.25 145.93 136.56 107.44 111.71
122.76 17.258 6
4.24 2.99 5.26 3.54 3.86 4.72
4.10 0.819 6
6.28 4.57 5.92 6.34
5.78 0.826 4
6.01 3.94 4.76 5.13 4.14 3.63
4.60 0.881 6
003527
773
ANIMAL NUMBER
CORTISOL //g/dL
Appendix 6
Summary and Individual Blood Hormone Determination Day -40
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS
TESTOSTERONE ng/mL
ESTRADIOL pg/mL
ESTRONE pg/mL
ESTRIOL pg/mL
THYROID STIMULATING /AJ/mL
TOTAL TRIIODOTHYRONINE
ng/dL
Covance 6329-223 3M T-6295.7
TOTAL THYROXIN
//g/dL
Group: Male 4 Dose Level: 0.75
105506 105507 105509 105511 105512 105522
49.42 44.53 82.95 75.12 81.05 58.08
1.27 7.01 1.03 16.78 0.14 10.11
MEAN S.D. N
65.19 16.683
6
6.06 6.565 6
Group: Female 1 Dose Level: 0
105529 105530 105531 105535 105544 105549
81.80 70.50 85.44 85.08 89.58 66.75
0.41 0.01 0.25 0.37 0.44 0.15
MEAN S.D. N
79.86 9.123 6
0.27 0.168 6
Group: Female 2 Dose Level: 0.03
105537 105541 105547 105550
79.24 108.45
67.50 89.13
0.17 0.77 0.19 0.23
MEAN S.D. N
86.08 17.337
4
0.34 0.288 4
Dosage Unit: mg/kg/day
28.98 32.46 27.21 37.12 37.24 52.20
21.20 30.79 14.40 42.06 21.98 49.26
0.00 0.00 0.00 0.00 0.00 0.00
35.87 8.991 6
29.95 13.432
6
0.00 0.000 6
Dosage Unit: mg/kg/day
42.94 90.55 52.80 79.48 72.70 50.29
31.46 65.47 91.87 52.46 46.44 34.57
0.00 0.00 0.00 0.00 0.00 0.00
64.79 18.833
6
53.71 22.407
6
0.00 0.000 6
Dosage Unit: mg/kg/day
59.21
116.25 40.43 62.40
48.11 90.73 67.42 61.31
0.00 0.00 0.00 0.00
69.57 32.593
4
66.89 17.818
4
0.00 0.000 4
0.82 1.92 0.57 0.59 0.25 1.54
0.95 0.643 6
0.00 0.00 0.11 0.73 2.16 0.69
0.62 0.827 6
0.01 0.26 1.14 0.93
0.59 0.536 4
157.93 88.90
116.45 188.61 169.66 158.85
146.73 36.914 6
75.62 128.68
73.71 125.42 106.71
76.27
97.74 25.813
6
131.29 132.70
86.87 88.98
109.96 25.465 4
5.12 6.69 4.44 4.90 3.80 3.42
4.73 1.157 6
4.60 5.65 4.93 4.02 3.73 4.49
4.57 0.680 6
6.03 6.63 4.59 2.99
5.06 1.624 4
00352S
774
ANIMAL NUMBER
CORTISOL //g/dL
Appendix 6
Summary and Individual Blood Hormone Determination Day -40
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS
TESTOSTERONE ng/mL
ESTRADIOL pg/mL
ESTRONE pg/mL
ESTRIOL pg/mL
THYROID STIMULATING //U/mL
TOTAL TRI IODOTHYRONINE
ng/dL
Covance 6329-223 3M T-6295.7
TOTAL THYROXIN
//g/dL
Group: Female 3 Dose Level: 0.15
105532 105538 105539 105545 105548 105552
63.15 70.84 68.60 64.50 67.75 53.55
0.06 0.08 0.35 0.13 0.66 0.40
MEAN S.D. N
64.73 6.148 6
0.28 0.234 6
Group: Female 4 Dose Level: 0.75
105533 105534 105536 105540 105542 105551
69.41 60.42 66.67 65.40 92.90 64.20
0.73 0.28 0.15 0.08 0.32 0.42
MEAN S.D. N
69.83 11.681
6
0.33 0.230 6
Dosage Unit: mg/kg/day
33.18 53.04 492.12
114.49 75.11 45.64
29.09 40.85 272.75 81.43 55.06 48.94
0.00 0.00 0.00 0.00 0.00 0.00
135.60 176.980
6
88.02 92.174
6
0.00 0.000 6
Dosage Unit: mg/kg/day
90.70 60.87 66.36 35.46 59.88 76.86
76.17 66.05 59.95 33.64 43.92 82.48
0.00 0.00 0.00 0.00 0.00 0.00
65.02 18.541
6
60.37 18.740
6
0.00 0.000 6
1.38 0.00 1.33 0.17 0.00 2.13
0.84 0.901 6
0.00 0.13 0.04 1.39 1.02 0.24
0.47 0.587 6
95.64 114.53 114.65 106.43 116.19
82.66
105.02 13.401 6
108.13 81.98
114.01 119.54 151.57 108.31
113.92 22.513 6
4.36 3.19 6.09 4.61 4.02 4.69
4.49 0.953 6
4.03 4.39 5.41 4.36 7.00 5.21
5.07 1.087 6
003529
775
ANIMAL NUMBER
CORTISOL fig/6L
Appendix 6
Summary and Individual Blood Hormone Determination Day -27
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS
TESTOSTERONE ng/mL
ESTRADIOL pg/mL
ESTRONE pg/mL
ESTRIOL pg/mL
THYROID STIMULATING /IU/mL
TOTAL TRI IODOTHYRONINE
ng/dL
Covance 6329-223 3M T-6295.7
TOTAL THYROXIN
ftg/h
Group: Male 1 Dose Level : 0
105508 105517 105519 105520 105526 105527
59.85 50.40 74.30 55.75 72.92 67.71
2.60 2.25 0.40 3.11 0.48 2.43
MEAN S.D. N
63.49 9.676 6
1.88 1.151 6
Group: Male 2 Dose Level : 0.03
105514 105515 105516 105521
81.35 77.44 50.15 61.80
1.41 1.40 0.31 3.03
MEAN S.D. N
67.69 14.422
4
1.54 1.121 4
Group: Male 3 Dose Level: 0.15
105505 105510 105518 105523 105524
105528
58.10 68.33 54.45 66.60 91.70 69.75
5.40 0.38 1.06 2.36 1.11 0.74
MEAN S.D. N
68.16 13.025
6
1.84 1.867 6
Dosage Unit : mg/kg/day
18.82 35.11 25.09 29.31 22.23 29.56
27.46 41.06 31.24 51.38 21.97 26.74
0.00 0.00 0.00 0.00 0.00 0.00
26.69 5.838 6
33.31 10.926
6
0.00 0.000 6
Dosage Unit: mg/kg/day
31.71 26.17 29.91 40.47
43.75 32.63 35.52 57.63
0.00 0.00 0.00 0.00
32.07 6.060 4
42.38 11.204
4
0.00 0.000 4
Dosage Unit: mg/kg/day
30.42 25.88 26.53 25.62 23.61 22.60
27.04 22.77 39.19 37.12 32.22 21.66
0.00 0.00 0.00 0.00 0.00 0.00
25.78 2.718 6
30.00 7.358 6
0.00 0.000 6
0.00 0.00 0.00 0.00 0.00 0.00
0.00 0.000 6
0.00 0.00 0.00 0.00
0.00 0.000 4
0.00 0.00 0.32 0.00 0.00 0.00
0.05 0.131 6
101.15 112.05 112.26 115.75 127.37
92.95
110.26 11.939 6
120.88 126.21
97.87 105.02
112.50 13.269 4
117.98 114.00 149.51 140.05
86.43 100.82
118.13 23.608 6
3.82 3.11 4.39 2.89 2.83 3.90
3.49 0.637 6
5.30 2.51 5.85 4.16
4.46 1.475 4
5.76 3.90 4.50 6.33 3.74 3.55
4.63 1.155 6
003530
776
ANIMAL NUMBER
CORTISOL /g/dL
Appendix 6
Summary and Individual Blood Hormone Determination Day -27
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS
TESTOSTERONE ng/mL
ESTRADIOL pg/mL
ESTRONE pg/mL
ESTRIOL pg/mL
THYROID STIMULATING //U/mL
TOTAL TRIIODOTHYRONINE
ng/dL
Covance 6329-223 3M T-6295.7
TOTAL THYROXIN
/ig/dL
Group : Male 4 Dose Level: 0.75
105506 105507 105509 105511 105512 105522
47.35 48.45 71.85 71.00 65.67 61.00
0.85 1.81 1.13 2.40 0.17 3.96
MEAN S.D. N
60.89 10.801
6
1.72 1.341 6
Group: Female 1 Dose Level : 0
105529 105530 105531 105535 105544 105549
72.55 76.75 48.35 68.60 52.84 55.44
0.28 0.07 0.50 0.35 0.42 0.07
MEAN S.D. N
62.42 11.701
6
0.28 0.179
6
Group: Female 2 Dose Level: 0.03
105537 105541 105547 105550
80.90 66.41 83.87 47.16
0.16 0.17 0.46
0.31
MEAN S.D. N
69.59 16.783
4
0.28 0.141 4
Dosage Unit: mg/kg/day
26.15 32.25 24.92 24.62 33.79 36.25
31.68 32.53 22.42 48.45 36.30 41.15
0.00 0.00 0.00 0.00 0.00 0.00
29.66 5.047 6
35.42 8.885 6
0.00 0.000 6
Dosage Unit: mg/kg/day
35.08 122.95
75.71 61.83 208.06 45.31
49.80 102.72
92.55 59.99 101.29 59.93
0.00
0.00 0.00 0.00 0.00 0.00
91.49 64.841
6
77.71 23.710
6
0.00 0.000 6
Dosage Unit: mg/kg/day
63.92 70.21 65.82 44.95
82.77 78.87 70.18 119.41
0.00 0.00 0.00 0.00
61.23 11.165
4
87.81
21.716 4
0.00 0.000 4
0.00 0.00 0.00 0.00 0.00 0.00
0.00 0.000 6
0.00 0.01 0.00 0.00 1.26 0.00
0.21 0.514 6
0.00 0.00 0.00 0.00
0.00 0.000 4
149.78 117.94 130.15 137.80 128.50 133.19
132.89 10.581 6
82.65 184.14
90.39 109.23 145.88
99.05
118.56 38.982 6
167.85 119.83 284.36 110.60
170.66 79.847 4
5.35 6.72 5.49 4.61 3.49 3.60
4.88 1.235 6
4.40 8.76 8.31 5.76 5.54 5.97
6.46 1.705 6
9.01 7.95 6.35 4.93
7.06 1.792 4
003531
777
ANIMAL NUMBER
CORTISOL /g/dL
Appendix 6
Summary and Individual Blood Hormone Determination Day -27
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS
TESTOSTERONE ng/mL
ESTRADIOL pg/mL
ESTRONE pg/mL
ESTRIOL pg/mL
THYROID STIMULATING /IU/mL
TOTAL TRIIODOTHYRONINE
ng/dL
Covance 6329-223 3M T-6295.7
TOTAL THYROXIN
/jg/dL
Group: Female 3 Dose Level: 0.15
105532 105538 105539 105545 105548 105552
57.80 87.05 50.45 57.66 56.95 62.72
0.18 0.09 0.08 0.03 0.59 0.54
MEAN S.D. N
62.11 12.832
6
0.25 0.248 6
Group: Female 4 Dose Level: 0.75
105533 105534 105536 105540 105542 105551
80.05 71.00
48.50 68.05 82.95 63.39
0.55 0.19 0.16 0.05 0.37 0.18
MEAN S.D. N
68.99 12.436
6
0.25 0.179 6
Dosage Unit: mg/kg/day
73.31 34.86 45.40 97.36 80.60 35.64
64.68 46.45 87.24 92.73 76.53 71.52
0.00 0.00 0.00 0.00 0.00 0.00
61.20 26.181
6
73.19 16.617
6
0.00 0.000 6
Dosage Unit: mg/kg/day
197.69 75.81 51.69 27.69 53.10
133.61
243.31 98.79 75.52 27.51 54.14
259.85
0.00 0.00 0.00 0.00 0.00 0.00
89.93 63.894
6
126.52 99.828 6
0.00 0.000 6
1.98 0.00 0.00 0.00 0.00 0.08
0.34 0.802 6
0.04 0.00 0.00 0.00 0.00 0.00
0.01 0.016 6
221.66 133.62 122.82 126.61 125.43
99.82
138.33 42.411 6
298.47 161.23 130.92
94.60 124.93 119.61
154.96 73.494 6
8.42 6.15 8.69 7.04 5.95 6.53
7.13 1.168 6
7.38 6.76 6.89 4.96 8.88 7.73
7.10 1.295 6
003532
778
ANIMAL NUMBER
CORTISOL //g/dL
Appendix 6
Summary and Individual Blood Hormone Determination Day 37
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS
TESTOSTERONE ng/mL
ESTRADIOL pg/mL
ESTRONE pg/mL
ESTRIOL pg/mL
THYROID STIMULATING //U/mL
TOTAL TRI IODOTHYRONINE
ng/dL
Covance 6329-223 3M T-6295.7
TOTAL THYROXIN
/ig/dL
Group: Male 1 Dose Level : 0
105508 105517 105519 105520 105526 105527
59.57 58.12 56.30 51.45 54.80 56.59
0.56 1.38 0.36 2.11 0.89 10.76
MEAN S.D.
N
56.14 2.818 6
2.68 4.010 6
Group: Male 2 Dose Level: 0.03
105514 105515 105516 105521
' 72.96 56.42 53.39 60.98
2.64 0.94 0.22 10.10
MEAN S.D. N
60.94 8.601 4
3.48 4.532 4
Group : Male 3 Dose Level: 0.15
105505 105510 105518 105523 105524 105528
61.35 66.10 52.23 61.98 64.07 73.61
0.76 0.60 0.83 2.11 0.68 1.04
MEAN S.D. N
63.22 6.968 6
1.00 0.563 6
Dosage Unit: mg/kg/day
14.21 30.66 19.61 31.75 17.02 31.22
21.01 42.28 34.97 65.45 32.02 47.15
0.00 0.00 0.00 0.00 0.00 0.00
24.08 8.004 6
40.48 15.181
6
0.00 0.000 6
Dosage Unit: mg/kg/day
32.81 23.69 14.32 37.38
84.41 39.25 48.23 98.72
0.00 0.00 0.00 0.00
27.05 10.218
4
67.65 28.460
4
0.00 0.000 4
Dosage Unit: mg/kg/day
23.37 24.13 26.75 27.07 15.77
10.40
36.78 29.76 38.59 44.88 33.62 23.33
0.00 0.00 0.00 0.00 0.00 0.00
21.25 6.703 6
34.49 7.452 6
0.00 0.000 6
0.02 0.86 0.00 0.00 0.47 0.70
0.34 0.387 6
0.70 0.43 0.13 0.14
0.35 0.272 4
0.07 0.68 0.92 0.00 0.32 0.01
0.33 0.387 6
252.81 298.92 279.29 241.26 316.62 250.74
273.27 30.081 6
306.12 283.59 272.54 229.90
273.04 31.973 4
265.64 255.41 272.85 284.01 221.20 228.32
254.57 25.007 6
3.21 4.67 4.18 4.63 3.30 4.37
4.06 0.649 6
6.21 3.96 4.83 5.43
5.11 0.951 4
4.21 4.29 3.46 5.45 3.41 3.17
4.00 0.844 6
003533
779
ANIMAL NUMBER
CORTISOL pg/AL
Appendix 6
Summary and Individual Blood Hormone Determination Day 37
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS
TESTOSTERONE ng/mL
ESTRADIOL pg/mL
ESTRONE pg/mL
ESTRIOL pg/mL
THYROID STIMULATING /iU/mL
TOTAL TRIIODOTHYRONINE
ng/dL
Covance 6329-223 3M T-6295.7
TOTAL THYROXIN
flg/L
Group: Male 4 Dose Level: 0.75
105506 105507 105509 105511 105512 105522
60.57 69.37 86.47
75.68 64.22 53.06
1.13 14.80
1.24 1.50 0.25 37.59
MEAN S.D. N
68.23 11.785
6
9.42 14.866
6
Group: Female 1 Dose Level: 0
105529 105530 105531 105535 105544 105549
58.61 77.09 60.99 61.72 62.18 56.68
0.31 0.08 0.20 0.25 0.46 0.18
MEAN S.D. N
62.88 7.266 6
0.25 0.130 6
Group: Female 2 Dose Level: 0.03
105537 105541 105547
105550
76.40 81.53 63.15 64.55
0.23 0.31 0.39 0.27
MEAN S.D. N
71.41 8.993 4
0.30 0.068 4
Dosage Unit: mg/kg/day
24.16 51.78 17.49
6.35 21.10 69.66
182.56 91.86 35.79 35.89 39.97
162.36
0.00 0.00 0.00 0.00 0.00 0.00
31.76 23.908
6
91.41 66.580
6
0.00 0.000 6
Dosage Unit: mg/kg/day
42.85 39.24
88.53 40.91 75.30 65.95
72.21 74.66 208.96 63.01 65.02 56.58
0.00 0.00 0.00 0.00 0.00 0.00
58.80 20.805
6
90.07 58.605
6
0.00 0.000 6
Dosage Unit: mg/kg/day
64.21 61.86 45.86 55.39
177.41 127.77
76.97 143.29
0.00 0.00 0.00 0.00
56.83 8.209 4
131.36 41.770 4
0.00 0.000 4
0.00 0.36 0.66 0.14 0.04 0.03
0.21 0.259 6
0.18 0.69 0.27 0.40 2.61 0.21
0.73 0.941 6
0.00 0.01 0.68 0.27
0.24 0.319 4
229.83 199.81 259.19 230.58 246.92 270.21
239.42 25.037 6
256.85 189.21 211.24 267.83 216.47 236.08
229.61 29.621 6
279.90 240.82 223.65 232.10
244.12 24.864 4
3.61 3.33 4.31 4.22 2.99 3.18
3.61 0.549 6
5.54 8.01 6.09 5.64 4.38 5.23
5.82 1.217 6
6.02 6.09 4.37 3.75
5.06 1.180
4
003534
780
ANIMAL NUMBER
CORTISOL fig/Ah
Appendix 6
Summary and Individual Blood Hormone Determination Day 37
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS
TESTOSTERONE ng/mL
ESTRADIOL pg/mL
ESTRONE pg/mL
ESTRIOL pg/mL
THYROID STIMULATING flU/mL
TOTAL TRI IODOTHYRONINE
ng/dL
Covance 6329-223 3M T-6295.7
TOTAL THYROXIN
ftg/dL
Group : Female 3 Dose Level: 0.15
105532 105538 105539 105545 105548 105552
66.39 54.30 50.23 46.45 46.73 56.82
0.20 0.07 0.08 0.09 0.30 0.48
MEAN S.D. N
53.49 7.537 6
0.20 0.162 6
Group: Female 4 Dose Level: 0.75
105533 105534 105536 105540 105542 105551
63.27 53.74 55.56 54.54 54.14 68.07
0.29 0.15 0.19 0.07 0.09 0.12
MEAN S.D.
N
58.22 5.998 6
0.15 0.080 6
Dosage Unit: mg/kg/day
383.80 27.95 38.80
119.09 34.02 27.36
351.81 58.49 86.17
227.52 52.35 51.92
0.00 0.00 0.00 0.00 0.00 0.00
105.17 140.935
6
138.04 124.485
6
0.00 0.000 6
Dosage Unit: mg/kg/day
70.06 49.92 42.44 31.28 67.52 104.58
150.87
123.86 63.03 47.69 67.27
271.41
0.00 0.00 0.00 0.00 0.00 0.00
60.97 25.978
6
120.69 83.839 6
0.00 0.000 6
1.56 0.00 1.21 0.00 0.00 0.91
0.61 0.703 6
1.07 1.59 0.00 0.26 0.52 0.10
0.59 0.622 6
192.15 225.80 221.63 237.82 184.62 220.15
213.70 20.701 6
190.90 203.76 204.79 191.80 196.18 190.95
196.40 6.414 6
4.53 3.21 3.49 4.18 2.78 3.89
3.68 * 0.646 6
3.51 5.03 3.62 3.16 4.84 5.21
4.23 * 0.895 6
003535
781
ANIMAL NUMBER
CORTISOL pg/dL
Appendix 6
Summary and Individual Blood Hormone Determination Day 62
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS
TESTOSTERONE ng/mL
ESTRADIOL pg/mL
ESTRONE pg/mL
ESTRIOL pg/mL
THYROID STIMULATING flU/mL
TOTAL TRIIODOTHYRONINE
ng/dL
Covance 6329-223 3M T-6295.7
TOTAL THYROXIN
/ig/dL
Group: Male 1 Dose Level : 0
105508 105517 105519 105520 105526 105527
64.62 57.71
60.20 50.13 63.25 43.13
0.50 1.30 0.39 2.28 0.65 1.40
MEAN S.D. N
56.51 8.318 6
1.09 0.719 6
Group: Male 2 Dose Level: 0.03
105514 105515 105516 105521
86.10 59.33 49.45 62.77
2.10 0.67 0.27 3.13
MEAN S.D. N
64.41 15.522
4
1.54 1.318 4
Group: Male 3 Dose Level: 0.15
105505 105510 105518 105523 105524 105528
70.82 58.68 60.80 76.60 62.76 63.38
1.07 0.51 0.77 2.83 0.94 0.77
MEAN S.D. N
65.51 6.813 6
1.15 0.845 6
Dosage Unit: mg/kg/day
17.70 35.89 27.43 27.41 15.13 38.03
28.21 51.07 24.22 69.97
34.66 42.05
0.00 0.00 0.00 0.00 0.00 0.00
26.93 9.256 6
41.70 16.877
6
0.00 0.000 6
Dosage Unit: mg/kg/day
29.19 27.02 17.22 44.97
71.76 53.19 77.85 95.20
0.00 0.00 0.00 0.00
29.60 11.494
4
74.50 * 17.333
4
0.00 0.000 4
Dosage Unit: mg/kg/day
34.40 25.73 31.30 35.79 21.61 14.54
36.91 26.22 30.11 62.53 31.79 33.29
0.00 0.00 0.00 0.00 0.00 0.00
27.23 8.199 6
36.81 13.086
6
0.00 0.000 6
0.25 1.72 0.00 0.00 0.00 1.42
0.57 0.790 6
0.54 0.11 0.47 0.57
0.42 0.213 4
1.22 1.53 2.85 0.00 0.00 0.29
0.98 1.118 6
119.34 163.61 145.97 164.61 139.41 135.30
144.71 17.407 6
147.03 143.03 118.77 148.62
139.36 13.928 4
131.32 117.68 167.15 166.99 135.36 131.96
141.74 20.528 6
2.89 2.79 2.77 3.81 1.73 2.55
2.76 0.667 6
4.36 3.15 4.47 3.64
3.91 * 0.624 4
3.22 2.56 2.73 4.44 2.60 2.90
3.08 0.711 6
003S36
782
ANIMAL NUMBER
CORTISOL //g/dL
Appendix 6
Summary and Individual Blood Hormone Determination Day 62
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS
TESTOSTERONE ng/mL
ESTRADIOL pg/mL
ESTRONE pg/mL
ESTRIOL pg/mL
THYROID STIMULATING //U/mL
TOTAL TRIIODOTHYRONINE
ng/dL
Covance 6329-223 3M T-6295.7
TOTAL THYROXIN
//g/dL
Group: Male 4 Dose Level: 0.75
105506 105507 105509 105511 105512 105522
70.92 69.36 80.21 83.50 69.38 65.14
0.61 2.05 1.10 1.52 0.19 1.87
MEAN S.D. N
73.09 * 7.137
6
1.22 0.728 6
Group: Female 1 Dose Level: 0
105529 105530 105531 105535 105544 105549
73.17 80.23 63.57
77.78 72.02 67.18
0.25 0.03 0.23 0.29 0.24 0.11
MEAN S.D. N
72.33 6.264 6
0.19 0.100 6
Group : Female 2 Dose Level: 0.03
105537 105541 105547 105550
75.87 88.44 67.51 72.45
0.24
0.30 0.41 0.42
MEAN S.D. N
76.07 8.934 4
0.34 0.087 4
Dosage Unit: mg/kg/day
6.89 14.27
8.28 4.43 20.03 30.27
84.83 50.89 33.16 43.47 35.68 56.44
0.00 0.00 0.00 0.00 0.00 0.00
14.03 9.757 6
50.75 18.886
6
0.00 0.000 6
Dosage Unit: mg/kg/day
42.49 40.60 87.01 135.19 110.97 88.68
95.52 73.45 154.45 166.44 116.03 104.97
0.00 0.00 0.00 0.00 0.00 0.00
84.16 37.377
6
118.48 35.602 6
0.00 0.000 6
Dosage Unit: mg/kg/day
97.35 95.89 71.56 63.70
171.29 128.24 149.12 160.38
0.00 0.00 0.00 0.00
82.13 17.053
4
152.26 18.393 4
0.00 0.000 4
0.00 0.33 0.97 0.00 0.00 0.00
0.22 0.392 6
2.88 0.32 0.00 0.00 3.86 0.10
1.19 1.718 6
0.00 0.09 1.74 0.00
0.46 0.856 4
110.61 96.11
120.78 133.14 121.31 142.07
120.67 16.237 6
86.34 157.85 105.00 104.25
94.26 141.85
114.93 28.369 6
178.52 124.69 122.85 116.15
135.55 28.879 4
2.24 2.24 3.01 3.42 1.84 2.79
2.59 0.585 6
2.55 5.01 3.16 3.14 3.32 3.98
3.53 0.859 6
4.64 5.27 3.51 2.87
4.07 1.083
4
003537
783
ANIMAL NUMBER
CORTISOL //g/dL
Appendix 6
Summary and Individual Blood Hormone Determination Day 62
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS
TESTOSTERONE ng/mL
ESTRADIOL pg/mL
ESTRONE pg/mL
ESTRIOL pg/mL
THYROID STIMULATING fRJ/mL
TOTAL TRIIODOTHYRONINE
ng/dL
Covance 6329-223 3M T-6295.7
TOTAL THYROXIN
//g/dL
Group: Female 3 Dose Level: 0.15
105532 105538 105539 105545 105548 105552
63.46 62.14 65.91 60.86 48.14 61.25
0.05 0.06 0.00 0.05 0.36 0.44
MEAN S.D. N
60.29 6.228 6
0.16 0.189 6
Group: Female 4 Dose Level: 0.75
105533 105534 105536 105540 105542 105551
68.36 67.55 73.98 73.87
66.81 113.15
1.04 0.05 0.12 0.09 0.40
0.10
MEAN S.D. N
77.29 17.850
6
0.30 0.384 6
Dosage Unit: mg/kg/day
196.89 40.91 50.54
142.62 60.76 60.28
162.41 57.31
122.72 226.73
96.83 85.06
0.00 0.00 0.00 0.00 0.00 0.00
92.00 63.048
6
125.18 61.195 6
0.00 0.000 6
Dosage Unit: mg/kg/day
539.64 21.16 53.49 47.69
414.10 98.43
637.44 92.30
103.29 87.57
248.93 208.43
0.00 0.00 0.00 0.00 0.00 0.00
195.75 222.733
6
229.66 210.776
6
0.00 0.000 6
3.00 0.00 1.30 0.00 0.48 0.13
0.82 1.176 6
1.64 1.91 0.17 0.00 0.69 0.00
0.74 0.849 6
100.87 122.69 109.98 147.17
99.01 102.13
113.64 18.596 6
92.49 104.34 101.67 102.37
84.83 85.64
95.22 8.753 6
4.30 1.97 3.15 2.68 1.94 2.55
2.77 0.880 6
2.41 3.70 2.53 1.65 3.75 4.45
3.08 1.049 6
003538
784
ANIMAL NUMBER
CORTISOL //g/dL
Appendix 6
Summary and Individual Blood Hormone Determination Day 91
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295> IN CYNOMOLGUS MONKEYS
TESTOSTERONE ng/mL
ESTRADIOL pg/mL
ESTRONE pg/mL
ESTRIOL pg/mL
THYROID STIMULATING ftU/mL
TOTAL TRIIODOTHYRONINE
ng/dL
Covance 6329-223 3M T-6295.7
TOTAL THYROXIN //g/dL
Group: Male 1 Dose Level : 0
105508 105517 105519 105520 105526 105527
63.12 72.02 68.04 50.11 60.09 48.19
0.65 1.78 0.44 2.53 0.96 1.57
MEAN S.D. N
60.26 9.547 6
1.32 0.786 6
Group: Male 2 Dose Level: 0.03
105514 105515 105516 105521
70.30 48.85 58.29 64.30
1.86 0.96 0.34 10.76
MEAN S.D. N
60.44 9.148 4
3.48 4.893 4
Group: Male 3 Dose Level: 0.15
105505 105510 105518 105523 105524 105528
63.97 58.44 52.27 64.33 73.62 72.47
1.54 1.05 0.90 2.03 0.82 0.73
MEAN S.D. N
64.18 8.157 6
1.18 0.506 6
Dosage Unit: mg/kg/day
3.16 22.72 14.07
19.55 16.52 35.93
20.61 53.30 30.76 65.61 29.74 51.35
0.00 0.00 0.00 0.00 0.00 0.00
18.66 10.784
6
41.90 17.359
6
0.00 0.000 6
Dosage Unit: mg/kg/day
29.08 29.88 28.37 41.20
82.17 40.06 40.27 107.46
0.00 0.00 0.00 0.00
32.13 * 6.076 4
67.49 33.199
4
0.00 0.000 4
Dosage Unit: mg/kg/day
17.57 20.81 20.88 20.84 13.64 21.33
37.08 34.69 26.72 47.88 34.88 23.84
0.00 0.00 0.00 0.00 0.00 0.00
19.18 3.040 6
34.18 8.478 6
0.00 0.000 6
0.00 0.00 0.00 0.00 0.00 0.00
0.00 0.000 6
0.00 0.00 0.00 0.00
0.00 0.000 4
0.00 0.00 0.17 0.00 0.00 0.00
0.03 0.069 6
141.51 162.07 144.10 148.94 161.62 162.45
153.45 9.720 6
166.24 148.07 151.67 146.06
153.01 9.120 4
143.76 141.60 156.52 174.10 119.61 143.77
146.56 18.023 6
3.96 4.25 3.67 4.53 2.93 4.02
3.89 0.553 6
5.41 4.38 5.22 6.17
5.30 * 0.735 4
4.56 4.37 4.49 6.03 3.93 3.45
4.47 0.870 6
003539
785
ANIMAL NUMBER
CORTISOL fig/h
Appendix 6
Summary and individual Blood Hormone Determination Day 91
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS
TESTOSTERONE ng/mL
ESTRADIOL pg/mL
ESTRONE pg/mL
ESTRIOL pg/mL
THYROID STIMULATING /IU/mL
TOTAL TRIIODOTHYRONINE
ng/dL
Covance 6329-223 3M T-6295.7
TOTAL THYROXIN
fig/h
Group: Male 4 Dose Level: 0.75
105506 105507 105509
105511 105512 105522
73.97 49.60 86.62 60.08 64.66 67.73
0.48 2.71 1.73 1.70 0.26 1.87
MEAN S.D. N
67.11 12.571
6
1.46 0.923 6
Group: Female 1 Dose Level : 0
105529 105530 105531 105535 105544 105549
74.49 69.78 50.36 62.89 70.71 65.26
0.55 0.06 0.30 0.29 1.05 0.32
MEAN S.D. N
65.58 8.513 6
0.43 0.342 6
Group: Female 2 Dose Level: 0.03
105537 105541 105547 105550
75.93 89.16 68.87 61.58
0.30 0.37 0.38 0.28
MEAN S.D. N
73.89 11.748
4
0.33 0.050 4
Dosage Unit: mg/kg/day
2.29 22.58
4.65 3.05 13.32 19.66
48.87 40.22 34.03 38.67 33.13 57.55
0.00 0.00 0.00 0.00 0.00 0.00
10.93 8.875 6
42.08 9.438 6
0.00 0.000 6
Dosage Unit: mg/kg/day
59.28 30.39 76.52 126.05 218.24 85.32
96.58 37.67 104.81 94.80 115.65 88.15
0.00 0.00 0.00 0.00 0.00 0.00
99.30 66.222
6
89.61 27.146
6
0.00 0.000 6
Dosage Unit: mg/kg/day
276.11 88.60 48.03 34.29
579.38 143.46
87.11 106.94
0.00 0.00 0.00 0.00
111.76 111.968
4
229.22 234.602
4
0.00 0.000 4
0.00 0.00 0.00 0.00 0.00 0.00
0.00 0.000 6
0.00 0.00 0.00 0.00 0.00 0.00
0.00 0.000 6
0.00 0.00 0.00 0.00
0.00 0.000 4
107.40 89.57
127.61 144.57 102.29 136.40
117.97 * 21.468 6
95.65 200.64 117.41 144.43 160.65 139.16
142.99 36.187 6
161.68 144.58 121.55 160.17
147.00 18.641 4
4.98 4.45 4.61 5.46 3.78 4.38
4.61 0.570 6
3.94 6.12 4.52 4.54 4.46 5.01
4.77 0.746 6
5.86 6.55 5.03 6.54
6.00 0.720 4
003540
786
ANIMAL NUMBER
CORTISOL (lq/dL
Appendix 6
Summary and Individual Blood Hormone Determination Day 91
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS
TESTOSTERONE ng/mL
ESTRADIOL pg/mL
ESTRONE pg/mL
ESTRIOL pg/mL
THYROID STIMULATING faJ/mL
TOTAL TRIIODOTHYRONINE
ng/dL
Covanee 6329-223 3M T-6295.7
TOTAL THYROXIN
fig/dL
Group : Female 3 Dose Level: 0.15
105532 105538 105539 105545 105548 105552
53.44 54.36 56.38 50.87
46.19 55.40
0.07 0.09 0.01 0.00 0.30 0.38
MEAN S.D. N
52.77 3.737 6
0.14 0.159 6
Group: Female 4 Dose Level : 0.75
105533 105534 105536 105540 105542
105551
63.67 57.80 71.04 85.09 58.02 91.43
0.51 0.04 0.14 0.26 0.23 0.42
MEAN S.D. N
71.18 14.228
6
0.27 0.174 6
Dosage Unit: mg/kg/day
208.42 55.31 48.35 64.59 29.92 74.01
161.28 71.47 96.47
142.80 64.58 74.24
0.00 0.00 0.00 0.00 0.00 0.00
80.10 64.629
6
101.81 40.773 6
0.00 0.000 6
Dosage Unit: mg/kg/day
162.24 34.90 29.06 42.06 95.90
394.36
186.20 67.09 60.95 65.39 72.08
503.53
0.00 0.00 0.00 0.00 0.00 0.00
126.42 140.697
6
159.21 175.397
6
0.00 0.000 6
0.09 0.00 0.00 0.00 0.00 0.00
0.02 0.037 6
0.00 0.00 0.00 0.00 0.00 0.00
0.00 0.000 6
120.33 113.79 114.24 113.45 109.64
92.26
110.62 * 9.628 6
95.87 81.56 92.51 90.84 81.86 83.67
87.72 * 6.128 6
4.88 3.27 3.49 4.38 3.13 3.47
3.77 0.697 6
4.18 5.45 4.94 3.81 5.99 5.15
4.92 0.807 6
003541
787
ANIMAL NUMBER
CORTISOL //g/dL
Appendix 6
Summary and Individual Blood Hormone Determination Day 182
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS
TESTOSTERONE ng/mL
ESTRADIOL pg/mL
ESTRONE pg/mL
ESTRIOL pg/mL
THYROID STIMULATING //U/mL
TOTAL TRIIODOTHYRONINE
ng/dL
Covance 6329-223 3M T-6295.7
TOTAL THYROXIN
//g/dL
Group: Male 1 Dose Level: 0
105508 105517
105519 105520 105526 105527
49.36 44.88 54.72 37.96 60.22 39.62
0.80 0.89 0.41 3.20 0.91 2.05
MEAN
S.D.
N
47.79 8.681 6
1.38 1.049 6
Group : Male 2 Dose Level: 0.03
105514 105515 105516 105521
57.72 41.90 43.62 53.31
1.43 0.44 0.31 8.03
MEAN S.D. N
49.14 7.613 4
2.55 3.686 4
Group: Male 3 Dose Level: 0.15
105505 105510 105518 105523 105524 105528
42.54 39.10 46.25 57.87 51.67 52.89
0.25 2.63 0.70 2.06 0.73 0.42
MEAN S.D. N
48.39 7.014 6
1.13 0.973 6
Dosage Unit: mg/kg/day
11.03 26.64 21.40 19.07 15.79 43.81
16.55 34.19 24.00 35.67 22.56 46.79
0.00 0.00 0.00 0.00 0.00 0.00
22.96 11.485
6
29.96 10.990
6
0.00 0.000 6
Dosage Unit: mg/kg/day
29.26 9.14
16.57 41.46
65.16 29.60 29.96 70.45
0.00 0.00 0.00 0.00
24.11 14.242
4
48.79 22.060
4
0.00 0.000 4
Dosage Unit: mg/kg/day
28.98 25.43 28.63 26.43 20.26
9.63
21.56 19.76 25.41
39.59 20.89 13.61
0.00 0.00 0.00 0.00 0.00 0.00
23.23 7.363 6
23.47 8.774 6
0.00 0.000 6
0.01 1.43 0.48 0.35 0.30 0.02
0.43 0.524 6
0.76 0.32 0.11 0.15
0.34 0.298 4
1.10 0.51 2.09 0.18 0.09 0.46
0.74 0.751 6
153.39 155.85 152.78 168.82 162.99 164.16
159.67 6.579 6
148.24 133.97
77.19 117.72
119.28 * 30.705 4
134.08 110.87 136.26 144.20 114.48 107.88
124.63 * 15.365 6
4.94 4.14 4.19 4.97 3.38 4.68
4.38 0.608 6
5.02 3.70 5.04 5.13
4.72 0.683 4
4.41 3.40 4.42 4.67 3.94 3.12
3.99 0.621 6
003542
788
ANIMAL NUMBER
CORTISOL //g/dL
Appendix 6
Summary and Individual Blood Hormone Determination Day 182
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS
TESTOSTERONE ng/mL
ESTRADIOL pg/mL
ESTRONE pg/mL
ESTRIOL pg/mL
THYROID STIMULATING //U/mL
TOTAL TRIIODOTHYRONINE
ng/dL
Covance 6329-223 3M T-6295.7
TOTAL THYROXIN
//g/dL
Group: Male 4 Dose Level: 0.75
105507 105511 105512 105522
59.90 43.70 70.20 59.49
2.10 0.69 0.04 1.80
MEAN S.D. N
58.32 10.935
4
1.16 0.961 4
Group : Female 1 Dose Level : 0
105529 105530 105531 105535 105544 105549
65.21 74.89 35.19 74.58 61.62 41.85
0.17 0.01 0.03 0.52 0.34 0.02
MEAN S.D. N
58.89 16.743
6
0.18 0.209 6
Group: Female 2 Dose Level: 0.03
105537 105541 105547 105550
76.03 61.45 39.39 59.31
0.29 0.13 0.26 0.14
MEAN S.D. N
59.05 15.063
4
0.21 0.082 4
Dosage Unit: mg/kg/day
0.00 1.01 0.00 2.00
33.59 27.68 22.69 36.89
0.00 0.00 0.00 0.00
0.75 * 0.958 4
30.21 6.298 4
0.00 0.000 4
Dosage Unit: mg/kg/day
232.49 47.22 51.65
318.47 162.44
78.63
351.64 68.58 77.36
239.29 153.92
61.78
0.00 0.00 0.00 0.00 0.00 0.00
148.48 110.143
6
158.76 116.512
6
0.00 0.000 6
Dosage Unit: mg/kg/day
254.69 47.66 41.73
156.72
492.79 101.86 164.10 364.55
0.00 0.00 0.00 0.00
125.20 101.227
4
280.83 180.363
4
0.00 0.000 4
1.59 0.34 0.59 1.18
0.93 0.566 4
1.33 0.00 0.00 0.06 2.75 0.22
0.73 1.115 6
0.00 0.08 0.85 1.77
0.68 0.824 4
58.09 97.68 34.06 75.57
66.35 * 26.941
4
95.65 183.66 115.47 139.41 152.04 125.36
135.27 30.659 6
148.10 131.20
98.77 102.12
120.05 23.703 4
5.27 7.00 3.25 5.85
5.34 1.569 4
4.83 7.22 5.01 5.84 5.08 5.95
5.66 0.894 6
5.29 5.85 3.35 2.84
4.33 1.462 4
003543
789
ANIMAL
NUMBER
CORTISOL //g/dL
Appendix 6
Summary and Individual Blood Hormone Determination Day 182
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS
TESTOSTERONE ng/mL
ESTRADIOL pg/mL
ESTRONE pg/mL
ESTRIOL pg/mL
THYROID STIMULATING /IU/mL
TOTAL TRIIODOTHYRONINE
ng/dL
Covance 6329-223 3H T-6295.7
TOTAL THYROXIN
/<g/dL
Group : Female 3 Dose Level : 0.15
105532 105538 105539 105545 105548 105552
47.71 36.38 42.82 48.24 32.13 48.26
0.01 0.04 0.00 0.04 0.03 0.16
MEAN
S.D.
N
42.59 6.904 6
0.05 0.058 6
Group: Female 4 Dose Level: 0.75
105533 105534 105536 105540 105542 105551
63.42 66.38 51.73 60.27 56.03 96.30
0.17
0.05 0.09 0.15 0.19 0.07
MEAN S.D.
N
65.69 15.876
6
0.12 0.058 6
Dosage Unit: mg/kg/day
197.86 45.10 52.30 52.62
39.61 36.02
141.98 64.69
100.79 74.46 51.74 60.51
0.00 0.00 0.00 0.00 0.00 0.65
70.59 62.705
6
82.36 33.716
6
0.11 0.265 6
Dosage Unit: mg/kg/day
36.11 9.45 0.00
47.41 93.61 52.80
55.31 37.27 53.37
60.05 115.82
99.85
0.00 0.00 0.00 0.00 0.00 0.00
39.90 33.589
6
70.28 30.505
6
0.00 0.000 6
4.33 0.25 0.89 0.62 0.98 0.57
1.27 1.520 6
2.31 1.10 0.62 0.21 0.55 0.22
0.84 0.793 6
90.44 100.45 106.11
86.22 103.15
93.10
96.58 * 7.824 6
83.76 81.38 76.41 71.65 92.22 104.92
85.06 * 11.963
6
4.36 2.83 3.63 4.00 4.03 4.59
3.91 * 0.622 6
5.31 6.31 5.96 3.74 5.83 6.49
5.61 1.002 6
003544
790
003545
ANIMAL NUMBER
Appendix 6
Summary and Individual Blood Hormone Determination Additional Collection - Terminal Sacrifice
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS
TOTAL
FREE
TOTAL
FREE
TRIIODOTHYRONINE TRIIODOTHYRONINE THYROXIN THYROXIN
ng/dL
pg/mL
/lg/dL ng/dL
Group: Male 1 Dose Level : 0
105508 105519 105527
126.89 110.98 107.16
5.18 3.61 3.83
MEAN S.D. N
115.01 10.464 3
4.21 0.850 3
Group: Male 2 Dose Level : 0.03
105514 105515 105516 105521
111.98 103.61 120.14 106.40
5.14 4.58 5.44 5.36
MEAN S.D. N
110.53 7.289 4
5.13 0.388 4
Group : Male 3 Dose Level : 0.15
105510 105518 105524 105528
95.90 93.03 86.79 100.26
4.19 4.41 3.88
4.85
MEAN S.D. N
94.00 * 5.649 4
4.33 0.408 4
Dosage Unit: mg/kg/day
3.46 2.73 3.56
1.02 0.86 1.15
3.25 0.453 3
1.01 0.145 3
Dosage Unit: mg/kg/day
3.97 3.01 4.11 4.31
1.07 1.10 1.16 1.50
3.85 0.577 4
1.21 0.199 4
Dosage Unit: mg/kg/day
2.88 2.49 2.38 3.07
1.02 0.93 0.79 1.01
2.71 0.324 4
0.94 0.106 4
791
Covance 6329-223 3M T-6295.7
003546
ANIMAL NUMBER
Appendix 6
Summary and Individual Blood Hormone Determination Additional Collection - Terminal Sacrifice
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS
TOTAL
FREE
TOTAL
FREE
TRIIODOTHYRONINE TRIIODOTHYRONINE THYROXIN THYROXIN
ng/dL
pg/mL
fig/dL
ng/dL
Group: Male 4 Dose Level: 0.75
105506 105507 105512
59.28 55.46 13.96
2.74 3.07 1.55
MEAN S.D. N
42.90 * 25.135
3
2.45 * 0.800 3
Group: Female 1 Dose Level: 0
105530 105531 105535 105544
131.98 87.43 98.87
104.98
5.33 3.10 3.48 4.28
MEAN S.D. N
105.82 18.899 4
4.05 0.986 4
Group: Female 2 Dose Level: 0.03
105541 105547 105550
109.59 81.34 86.09
4.13 3.14 3.49
MEAN S.D. N
92.34 15.127
3
3.59 0.502 3
Dosage Unit: mg/kg/day
4.90 3.16 1.83
1.36 1.15 0.86
3.30 1.540 3
1.12 0.251 3
Dosage Unit: mg/kg/day
5.50 2.62 4.93 3.52
1.43 0.78 1.17 0.86
4.14 1.313 4
1.06 0.299 4
Dosage Unit: mg/kg/day
4.24 3.41 2.80
1.32 0.86 0.85
3.48 0.723 3
1.01 0.269 3
792
Covance 6329-223 3M T-6295.7
ANIMAL NUMBER
Appendix 6
Summary and Individual Blood Hormone Determination Additional Collection - Terminal Sacrifice
26-WEEK c a p s u l e t o x i c i t y s t u d y w i t h p e r f l u o r o o c t a n e s u l f o n i c ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS
TOTAL
FREE
TOTAL
FREE
TRIIODOTHYRONINE TRIIODOTHYRONINE THYROXIN THYROXIN
ng/dL
pg/mL
//g/dL
ng/dL
Group: Female 3 Dose Level : 0.15
105532 105538 105545 105548
74.72 77.02 72.24 94.86
3.27 2.98 2.96 3.87
MEAN S.D. N
79.71 * 10.287
4
3.27 0.424 4
Group: Female 4 Dose Level : 0.75
105534 105536 105540 105551
51.14 59.03 60.77
64.05
2.88 2.43 3.13 2.83
MEAN S.D. N
58.75 * 5.482 4
2.82 0.290 4
Dosage Unit: mg/kg/day
3.03 1.89 2.71 3.88
1.04 0.59 0.90 1.06
2.88 0.823 4
0.90 0.217 4
Dosage Unit: mg/kg/day
4.52 3.87 2.04 3.30
1.49 1.00 0.79 1.03
3.43 1.054 4
1.08 0.295 4
Covance 6329-223 3M T-6295.7
003547
793
ANIMAL NUMBER
CORTISOL /ig/dL
Appendix 6
Summary and Individual Blood Hormone Determination Day 217
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS
TESTOSTERONE ng/mL
ESTRADIOL pg/mL
ESTRONE pg/mL
ESTRIOL pg/mL
THYROID STIMULATING //U/mL
TOTAL TRIIODOTHYRONINE
ng/dL
Covance 6329-223 3H T-6295.7
TOTAL THYROXIN
/ig/dL
Group : Male 1 Dose Level : 0
105520 105526
38.18 44.16
2.66 2.51
MEAN S.D. N
41.17 4.228 2
2.59 0.106 2
Group: Male 3 Dose Level: 0.15
105505 105523
27.26 52.61
0.99 3.84
MEAN S.D. N
39.94 17.925
2
2.42 2.015 2
Group : Male 4 Dose Level: 0.75
105511 105522
51.54 44.31
4.72 5.36
MEAN S.D. N
47.93 5.112 2
5.04 0.453 2
Dosage Unit: mg/kg/day
17.90 10.98
64.49 25.43
0.00 0.00
14.44 4.893 2
44.96 27.620
2
0.00 0.000 2
Dosage Unit: mg/kg/day
17.56 21.73
32.66 59.98
0.00 0.00
19.65 2.949 2
46.32 19.318
2
0.00 0.000 2
Dosage Unit: mg/kg/day
0.00 27.09
37.83 70.81
0.00 0.00
13.55 19.156
2
54.32 23.320
2
0.00 0.000 2
1.61 2.12
1.87 0.361 2
1.21 0.97
1.09 0.170 2
1.67 1.05
1.36 0.438 2
159.60 183.22
171.41 16.702 2
154.43 164.81
159.62 7.340 2
165.18 129.72
147.45 25.074 2
3.75 2.87
3.31 0.622 2
3.28 4.20
3.74 0.651 2
4.74 2.51
3.625 1.577 2
003548
794
ANIMAL NUMBER
CORTISOL fig/Ah
Appendix 6
Summary and Individual Blood Hormone Determination Day 217
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS
TESTOSTERONE ng/mL
ESTRADIOL pg/mL
ESTRONE pg/mL
ESTRIOL pg/mL
THYROID STIMULATING /JU/mL
TOTAL TRIIODOTHYRONINE
ng/dL
Covance 6329-223 3M T-6295.7
TOTAL THYROXIN
ftg/Ah
Group : Female 1 Dose Level: 0
105529 105549
54.69 40.39
0.86 0.12
MEAN S.D. N
47.54 10.112
2
0.49 0.523 2
Group : Female 3 Dose Level: 0.15
105539 105552
57.55 59.07
0.10 0.82
MEAN S.D. N
58.31 1.075 2
0.46 0.509 2
Group : Female 4 Dose Level: 0.75
105533 105542
55.91 66.34
0.61 0.37
MEAN S.D.
N
61.13 7.375 2
0.49 0.170 2
Dosage Unit: mg/kg/day
53.08 43.63
83.74 64.84
0.00 0.00
48.36 6.682 2
74.29 13.364
2
0.00 0.000 2
Dosage Unit: mg/kg/day
44.84 68.85
71.13 88.81
0.00 0.00
56.85 16.978
2
79.97 12.502
2
0.00 0.000 2
Dosage Unit: mg/kg/day
133.46 88.23
289.99 154.68
0.00 0.00
110.85 31.982 2
222.34 95.679 2
0.00 0.000 2
1.78 1.66
1.72 0.85 2
1.88 0.59
1.24 0.912 2
1.76 1.56
1.66 0.141 2
116.20 133.52
124.86 12.247 2
114.34 121.25
117.80 4.886 2
99.29 101.57
100.43 1.612 2
4.89 6.58
5.74 1.195 2
3.37 3.91
3.64 0.382 2
3.93 3.51
3.72 0.297 2
003549
795
ANIMAL NUMBER
CORTISOL //g/dL
Appendix 6
Summary and Individual Blood Hormone Determination Day 245
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS
TESTOSTERONE ng/mL
ESTRADIOL pg/mL
ESTRONE pg/mL
ESTRIOL pg/mL
THYROID STIMULATING nU/mL
TOTAL TRI IODOTHYRONINE
ng/dL
Covance 6329-223 3M T-6295.7
TOTAL THYROXIN
//9/dL
Group: Male 1 Dose Level : 0
105520 105526
52.17 44.90
2.83 1.40
MEAN S.D. N
48.54 5.141 2
2.12 1.011 2
Group: Male 3 Dose Level: 0.15
105505 105523
46.88 54.44
0.50 7.18
MEAN S.D.
N
50.66 5.346 2
3.84 4.723 2
Group : Male 4 Dose Level: 0.75
105511 105522
37.08 25.17
1.55 2.99
MEAN S.D. N
31.13 8.422 2
2.27 1.018 2
Dosage Unit: mg/kg/day
40.85 16.61
79.85 31.48
0.00 0.00
28.73 17.140
2
55.67 34.203
2
0.00 0.000 2
Dosage Unit: mg/kg/day
23.84 25.40
43.65 59.41
0.00 0.00
24.62 1.103 2
51.53 11.144
2
0.00 0.000 2
Dosage Unit: mg/kg/day
17.87 26.57
53.06 77.43
0.00 0.00
22.22 6.152 2
65.25 17.232
2
0.00 0.000 2
0.25 0.00
0.13 0.177 2
0.10 0.00
0.05 0.071 2
0.67 0.33
0.50 0.240 2
171.00 133.39
152.20 26.594 2
154.84 151.74
153.29 2.192 2
170.42 137.27
153.85 23.441 2
4.18 1.74
2.96 1.725 2
3.79 3.37
3.58 0.297 2
4.18 2.45
3.32 1.223 2
003550
796
ANIMAL NUMBER
CORTISOL //g/dL
Appendix 6
Summary and Individual Blood Hormone Determination Day 245
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS
TESTOSTERONE ng/mL
ESTRADIOL pg/mL
ESTRONE pg/mL
ESTRIOL pg/mL
THYROID STIMULATING //lJ/mL
TOTAL TRI IODOTHYRONINE
ng/dL
Covance 6329-223 3M T-6295.7
TOTAL THYROXIN
//g/dL
Group: Female 1 Dose Level : 0
105529 105549
56.47 43.54
0.12 0.07
MEAN S.D. N
50.01
9.143 2
0.10
0.035 2
Group: Female 3 Dose Level: 0.15
105539 105552
63.10 60.29
0.07 0.28
MEAN S.D. N
61.70 1.987 2
0.18 0.148 2
Group : Female 4 Dose Level: 0.75
105533 105542
62.75 81.69
0.66 0.06
MEAN S.D. N
72.22 13.393
2
0.36 0.424 2
Dosage Unit: mg/kg/day
38.61 112.14
95.66 115.58
0.00 0.00
75.38 51.994
2
105.62 14.086 2
0.00 0.000 2
Dosage Unit: mg/kg/day
61.24 88.08
137.78 94.05
0.00 0.00
74.66 18.979
2
115.92 30.922 2
0.00 0.000 2
Dosage Unit: mg/kg/day
257.61 114.63
255.84 120.11
0.00 0.00
186.12 101.102
2
187.98 95.976 2
0.00 0.000 2
0.68 0.98
0.83 0.212 2
0.81 0.00
0.41 0.573 2
1.04 0.82
0.93 0.156 2
130.32 136.09
133.21 4.080 2
127.17 142.77
134.97 11.031 2
118.99 121.98
120.49 2.114 2
4.93 5.81
5.37 0.622 2
3.56 3.76
3.66 0.141 2
3.84 3.38
3.61 0.325 2
TSSCO
797
ANIMAL NUMBER
CORTISOL //g/dL
Appendix 6
Summary and Individual Blood Hormone Determination Day 274
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS
TESTOSTERONE ng/mL
ESTRADIOL pg/mL
ESTRONE pg/mL
ESTRIOL pg/mL
THYROID STIMULATING flU/mL
TOTAL TRIIODOTHYRONINE
ng/dL
Covance 6329-223 3M T-6295.7
TOTAL THYROXIN
/ig/dL
Group : Male 1 Dose Level : 0
105520 105526
34.89 45.23
1.76 1.40
MEAN S.D. N
40.06 7.311 2
1.58 0.255 2
Group: Male 3 Dose Level: 0.15
105505 105523
42.85 61.34
3.64 2.55
MEAN S.D. N
52.10 13.074
2
3.10 0.771 2
Group: Male 4 Dose Level: 0.75
105511 105522
59.62 26.17
2.36 4.12
MEAN S.D. N
42.90 23.653
2
3.24 1.245 2
Dosage Unit: mg/kg/day
17.17 14.11
62.84 34.27
0.00 0.00
15.64 2.164 2
48.56 20.202
2
0.00 0.000 2
Dosage Unit: mg/kg/day
25.06 25.26
39.86 63.44
0.00 0.00
25.16 0.141 2
51.65 16.674
2
0.00 0.000 2
Dosage Unit: mg/kg/day
6.94 30.46
51.42 83.94
0.00 0.00
18.70
16.631 2
67.68
22.995 2
0.00 0.000 2
0.00 0.02
0.01 0.014 2
0.25 0.00
0.13 0.177 2
0.24 0.09
0.17 0.106 2
134.97 167.54
151.26 23.030 2
146.70 161.73
154.22 10.628 2
163.13 163.73
163.43 0.424 2
5.56 2.40
3.98 2.234 2
2.43 3.31
2.87 0.622 2
4.19 2.36
3.28 1.294 2
003552
798
ANIMAL NUMBER
CORTISOL //g/dL
Appendix 6
Summary and Individual Blood Hormone Determination Day 274
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS
TESTOSTERONE ng/mL
ESTRADIOL pg/mL
ESTRONE pg/mL
ESTRIOL pg/mL
THYROID STIMULATING //U/mL
TOTAL TRI IODOTHYRONINE
ng/dL
Covance 6329-223 3M T-6295.7
TOTAL THYROXIN
//g/dL
Group: Female 1 Dose Level: 0
105529 105549
64.71 47.01
0.44 0.02
MEAN S.D. N
55.86 12.516
2
0.23 0.297 2
Group: Female 3 Dose Level: 0.15
105539 105552
45.77 44.48
0.04 0.18
MEAN S.D. N
45.13 0.912 2
0.11 0.099 2
Group: Female 4 Dose Level: 0.75
105533 105542
49.13 63.28
0.49 0.40
MEAN S.D. N
56.21 10.006
2
0.45 0.064 2
Dosage Unit: mg/kg/day
43.91 42.07
115.88 57.38
0.00 0.00
42.99 1.301 2
86.63 41.366
2
0.00 0.000 2
Dosage Unit: mg/kg/day
48.03 114.70
127.24 124.21
0.00 0.00
81.37 47.143
2
125.73 2.143 2
0.00 0.000 2
Dosage Unit: mg/kg/day
109.08 108.09
153.99 128.04
0.00 0.00
108.59 0.700 2
141.02 18.349 2
0.00 0.000 2
0.00 0.68
0.34 0.481 2
0.29 0.00
0.15 0.205 2
0.64 0.01
0.33 0.445 2
91.10 130.21
110.66 27.655 2
114.25 103.46
108.86 7.630 2
115.88 85.17
100.53 21.715 2
4.88 4.88
4.88 0.000 2
3.00 2.98
2.99 0.014 2
2.59 3.22
2.91 0.445 2
C O
CCO/I
c/l
0 799
ANIMAL NUMBER
Appendix 6
Covance 6329-223 3M T-6295.7
Summary and Individual Blood Hormone Determination Day 322
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS
THYROID
TOTAL
FREE
TOTAL
FREE
CORTISOL TESTOSTERONE ESTRADIOL ESTRONE ESTRIOL STIMULATING TRIIODOTHYRONINE TRIIODOTHYRONINE THYROXIN THYROXIN
/g/dL
ng/mL
pg/mL
pg/mL pg/mL
/iU/mL
ng/dL
pg/mL
/<g/dL
ng/dL
Group: Male 1 Dose Level: 0
Dosage Unit: mg/kg/day
105520 105526
48.93 54.85
1.68 1.47
22.29 12.73
66.72 34.79
0.00 0.00
0.00 0.08
MEAN S.D. N
51.89 4.186 2
1.58 0.148 2
17.51 6.760 2
50.76 22.578
2
0.00 0.000 2
0.04 0.057 2
Group : Male 3 Dose Level: 0.15
Dosage Unit: mg/kg/day
105505 105523
35.82 56.14
0.16 2.50
21.68 21.64
35.93 55.20
0.00 0.00
0.15 0.00
MEAN S.D. N
45.98 14.368
2
1.33 1.655 2
21.66 0.028 2
45.57 13.626
2
0.00 0.000 2
0.08 0.106 2
Group: Male 4 Dose Level: 0.75
Dosage Unit: mg/kg/day
105511 105522
52.62 27.46
1.59 1.66
0.00 14.90
43.71 66.78
0.00 0.00
0.01 0.05
MEAN S.D. N
40.04 17.791
2
1.63 0.049 2
7.45 10.536
2
55.25 16.313
2
0.00 0.000 2
0.03 0.028 2
113.68 167.98
140.83 38.396 2
141.49 150.29
145.89 6.223 2
145.00 116.61
130.81 20.075 2
4.34 6.23
5.29 1.336 2
4.68 5.39
5.04 0.502 2
4.78 4.24
4.51 0.382 2
3.20 3.35
3.28 0.106 2
1.27 1.26
1.27 0.007 2
3.96 4.09
4.03 0.092 2
1.44 1.51
1.48 0.049 2
4.61 2.84
3.73 1.252 2
1.17 0.95
1.06 0.156 2
00355
800
ANIMAL NUMBER
Appendix 6
Covance 6329-223 3M T-6295.7
Summary and Individual Blood Hormone Determination Day 322
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS
THYROID
TOTAL
FREE
TOTAL
FREE
CORTISOL TESTOSTERONE: ESTRADIOL ESTRONE ESTRIOL STIMULATING TRIIODOTHYRONINE TRIIODOTHYRONINE THYROXIN THYROXIN
/g/dL
ng/mL
pg/mL
pg/mL pg/mL
//U/mL
ng/dL
pg/mL
/ig/dL
ng/dL
Group: Female 1
105529 105549
60.74 55.31
MEAN S.D. N
58.03 3.840 2
Group : Female 3
105539 105552
54.81 61.78
MEAN S.D. N
58.30 4.929 2
Group : Female 4
105533 105542
40.44 66.14
MEAN S.D. N
53.29 18.173
2
Dose Level : 0
Dosage Unit:: mg/kg/day
0.66 0.04
93.93 67.50
136.07 78.68
0.00 0.00
0.14 0.22
0.35 0.438 2
80.72
18.689 2
107 .38 40.581 2
0.00 0.000 2
0.18 0.057 2
Dose Level: 0.15
Dosage Unit: mg/kg/day
0.00 0.15
46.03 78.67
127.28 179.51
0.00 0.00
0.00 0.33
0.08 0.106 2
62.35 23.080
2
153.40 36.932 2
0.00 0.000 2
0.17 0.233 2
Dose Level : 0.75
Dosage Unit:: mg/kg/day
0.02 0.03
95.89 95.19
182.57 116.98
0.00 0.00
0.85 0.00
0.03 0.007 2
95.54 0.495 2
149.78 46.379 2
0.00 0.000 2
0.43 0.601 2
95.57 102.40
98.99 4.830 2
.102.53 86.79
94.66 11.130
2
127.50 94.51
111.01 23.327 2
3.84 3.31
3.58 0.375 2
2.30 2.66
2.48 0.255 2
4.40 2.64
3.52 1.245 2
3.87 4.09
3.98 0.156 2
1.16 1.37
1.27 0.148 2
3.24 3.34
3.29 0.071 2
0.99 1.04
1.02 0.035 2
4.41 4.04
4.23 0.262 2
1.38 1.08
1.23 0.212 2
003555
801
ANIMAL NUMBER
Appendix 6
Covance 6329-223 3M T-6295.7
Summary and Individual Blood Hormone Determination Day 364
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS
THYROID
TOTAL
FREE
TOTAL
FREE
CORTISOL TESTOSTERONE ESTRADIOL ESTRONE ESTRIOL STIMULATING TRIIODOTHYRONINE TRIIODOTHYRONINE THYROXIN THYROXIN
flg/dL
ng/mL
pg/mL
pg/mL pg/mL
/JU/mh
ng/dL
pg/mL
//g/dL
ng/dL
Group : Male 1 Dose Level : 0
Dosage Unit: mg/kg/day
105520 105526
56.87 50.92
2.87 2.98
31.48 22.18
71.33 39.48
0.00 0.00
0.00 0.01
MEAN S.D. N
53.90 4.207 2
2.93 0.078 2
26.83 6.576 2
55.41 22.521
2
0.00 0.000
2
0.01 0.007 2
Group: Male 3 Dose Level : 0.15
Dosage Unit: mg/kg/day
105505 105523
35.11 69.91
5.86 3.19
27.97 21.80
33.61 59.64
0.00 0.00
0.15 0.00
MEAN S.D. N
52.51 24.607
2
4.53 1.888 2
24.89 4.363 2
46.63 18.406
2
0.00 0.000 2
0.08 0.106 2
Group: Male 4 Dose Level : 0.75
Dosage Unit: mg/kg/day
105511 105522
53.56 42.27
2.07 1.98
12.59 22.13
50.72 61.86
0.00 0.00
0.00 0.00
MEAN S.D. N
47.92 7.983 2
2.03 0.064 2
17.36 6.746 2
56.29 7.877 2
0.00 0.000 2
0.00 0.000 2
142.33 173.51
157.92 22.048 2
141.33 136.42
138.88 3.472 2
189.73 142.92
166.33 33.100 2
4.92 5.87
5.40 0.672 2
4.17 4.73
4.45 0.396 2
6.84 6.13
6.49 0.502 2
3.54 3.31
3.43 0.163 2
1.36 1.43
1.40 0.049 2
3.71 3.76
3.74 0.035 2
1.35 1.21
1.28 0.099 2
3.92 3.06
3.49 0.608 2
1.07 1.07
1.07 0.000 2
003556
802
ANIMAL NUMBER
Appendix 6
Covance 6329-223 3M T-6295.7
Summary and Individual Blood Hormone Determination Day 364
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS
THYROID
TOTAL
FREE
TOTAL
FREE
CORTISOL TESTOSTERONE: ESTRADIOL ESTRONE ESTRIOL STIMULATING TRIIODOTHYRONINE TRIIODOTHYRONINE THYROXIN THYROXIN
//g/dL
ng/mL
pg/mL
pg/mL pg/mL
//U/mL
ng/dL
pg/mL
//g/dL
ng/dL
Group: Female 1
105529 105549
56.92 54.02
MEAN S.D. N
55.47
2.051 2
Group: Female 3
105539 105552
48.00 74.04
MEAN S.D. N
61.02 18.413
2
Group: Female 4
105533 105542
61.92 89.59
MEAN S.D. N
75.76 19.566
2
Dose Level: 0
Dosage Unit: mg/kg/day
0.36 0.01
46.66 72.28
106.07 120.53
0.00 0.00
0.38 0.00
0.19 0.247 2
59.47 18.116
2
113.30 10.225 2
0.00 0.000 2
0.19 0.269 2
Dose Level: 0.15
Dosage Unit: mg/kg/day
0.01 0.13
53.88 25.95
120.92 71.07
0.00 0.00
0.12 0.39
0.07 0.085 2
39.92 19.749
2
96.00 35.249
2
0.00 0.000 2
0.26 0.191 2
Dose Level : 0.75
Dosage Unit: mg/kg/day
0.13 0.07
166.75 164.57
352.52 175.61
0.00 0.00
0.28 0.00
0.10 0.042 2
165.66 1.541 2
264.07 125.094
2
0.00 0.000 2
0.14 0.198 2
114.22 94.96
104.59 13.619 2
113.58 89.22
101.40 17.225 2
108.62 105.87
107.25 1.945 2
3.48 2.75
3.12 0.516 2
2.73 3.99
3.36 0.891 2
3.84 3.34
3.59 0.354 2
3.48 3.89
3.69 0.290 2
1.17 1.40
1.29 0.163 2
3.40 3.06
3.23 0.240 2
1.10 1.03
1.07 0.049 2
3.20 3.31
3.26 0.078 2
1.15 1.07
1.11 0.057 2
003557
803
ANIMAL NUMBER
Appendix 6
Covance 6329-223 3M T-6295.7
Summary and Individual Blood Hormone Determination Day 456
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS
THYROID
TOTAL
FREE
TOTAL
FREE
CORTISOL TESTOSTERONE ESTRADIOL ESTRONE ESTRIOL STIMULATING TRIIODOTHYRONINE TRIIODOTHYRONINE THYROXIN THYROXIN
/Rj/dL
ng/mL
pg/mL
pg/mL pg/mL
flU/mL
ng/dL
pg/mL
fig/h
ng/dL
Group: Male 1 Dose Level : 0
Dosage Unit : mg/kg/day
105520 105526
45.28 42.55
3.12 2.03
24.62 20.60
33.29 17.89
0.00 0.00
4.00 3.18
MEAN S.D. N
43.92 1.930 2
2.58 0.771 2
22.61 2.843 2
25.59 10.889
2
0.00 0.000 2
3.59 0.580 2
Group: Male 3 Dose Level: 0.15
Dosage Unit: mg/kg/day
105505 105523
35.05 58.45
5.77 4.15
33.45 34.94
15.52 31.76
0.00 0.00
3.02 2.40
MEAN S.D. N
46.75 16.546
2
4.96 1.146 2
34.20 1.054 2
23.64 11.483
2
0.00 0.000 2
2.71 0.438 2
Group: Male 4 Dose Level: 0.75
Dosage Unit: mg/kg/day
105511 105522
34.37 18.72
2.19 5.27
15.15 32.89
34.29 47.87
0.00 0.00
2.70 2.67
MEAN S.D. N
26.55 11.066
2
3.73 2.178 2
24.02 12.544
2
41.08 9.603 2
0.00 0.000 2
2.69 0.021 2
160.85 158.81
159.83 1.442 2
156.75 189.99
173.37 23.504 2
200.22 142.75
171.49 40.637 2
7.90 7.34
7.62 0.396 2
5.12 8.58
6.85 2.447 2
8.55 6.89
7.72 1.174 2
5.07 3.03
4.05 1.442 2
2.53 1.83
2.18 0.495 2
4.10 4.63
4.37 0.375 2
1.85 2.07
1.96 0.156 2
3.56 4.05
3.81 0.346 2
1.51 1.83
1.67 0.226 2
003558
804
ANIMAL NUMBER
Appendix 6
Covance 6329-223 3M T-6295.7
Summary and Individual Blood Hormone Determination Day 456
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS
THYROID
TOTAL
FREE
TOTAL
FREE
CORTISOL TESTOSTERONE ESTRADIOL ESTRONE ESTRIOL STIMULATING TRIIODOTHYRONINE TRIIODOTHYRONINE THYROXIN THYROXIN
/g/dL
ng/mL
pg/mL
pg/mL pg/mL
//U/mL
ng/dL
pg/mL
dL ng/dL
Group: Female 1
105529 105549
61.24 45.43
MEAN S.D. N
53.34 11.179
2
Group : Female 3
105539 105552
59.18 40.35
MEAN S.D. N
49.77 13.315
2
Group : Female 4
105533 105542
52.84 88.82
MEAN S.D. N
70.83 25.442
2
Dose Level: 0
Dosage Unit: mg/kg/day
0.75 0.16
60.82 58.64
62.11 17.39
0.00 0.00
3.41 2.27
0.46 0.417
2
59.73 1.541 2
39.75 31.622
2
0.00 0.000 2
2.84 0.806 2
Dose Level: 0.15
Dosage Unit: mg/kg/day
0.06 0.15
111.82 63.26
73.29 56.27
0.00 0.00
5.31 5.26
0.11 0.064 2
87.54 34.337
2
64.78 12.035
2
0.00 0.000 2
5.29 0.035 2
Dose Level : 0.75
Dosage Unit: mg/kg/day
0.73 0.30
101.24 180.10
86.37 115.95
0.00 0.00
5.20 4.19
0.52 0.304 2
140.67 55.762 2
101.16 20.916 2
0.00 0.000 2
4.70 0.714 2
131.39 127.08
129.24 3.048 2
127.44 104.90
116.17 15.938 2
140.68 147.41
144.05 4.759 2
6.12 5.03
5.58 0.771 2
4.32 5.02
4.67 0.495 2
4.86 4.23
4.55 0.445 2
4.81 4.72
4.77 0.064 2
2.15 2.27
2.21 0.085 2
3.48 3.31
3.40 0.120 2
1.46 1.10
1.28 0.255 2
3.55 3.15
3.35 0.283 2
1.56 1.11
1.34 0.318 2
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ANIMAL NUMBER
Appendix 6
Covance 6329-223 3M T-6295.7
Summary and Individual Blood Hormone Determination Day 546
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS
THYROID
TOTAL
FREE
TOTAL
FREE
CORTISOL, TESTOSTERONE ESTRADIOL ESTRONE ESTRIOL STIMULATING TRI IODOTHYRONINE TRIIODOTHYRONINE THYROXIN THYROXIN
//g/dL
ng/mL
pg/mL
pg/mL pg/mL
//U/mL
ng/dL
pg/mL
/ig/dL
ng/dL
Group : Male 1 Dose Level : 0
Dosage Unit: mg/kg/day
105520 105526
41.44 48.80
3.51 2.29
19.03 21.13
35.81 22.20
0.00 0.00
3.01 3.34
MEAN
45.12
2.90
20.08
29.01 0.00
S.D.
5.204
0.863
1.485
9.624 0.000
N 2 2 2 22
Group: Male 3 Dose Level : 0. 15
Dosage Unit: mg/kg/day
3.18 0.233 2
105505 105523
43.54 55.25
2.03 4.77
22.13 33.60
11.11 27.76
0.00 0.00
3.11 3.17
MEAN S.D. N
49.40 8.280 2
3.40 1.937 2
27.87 8.111 2
19.44 11.773
2
0.00 0.000 2
3.14 0.042 2
Group: Male 4 Dose Level : 0. 75
Dosage Unit: mg/kg/day
105511 105522
31.74 17.51
6.17 6.28
27.18 30.18
34.39 40.74
0.00 0.00
1.92 3.36
MEAN S.D. N
24.63 10.062
2
6.23 0.078 2
28.68 2.121 2
37.57 4.490 2
0.00 0.000 2
2.64 1.018 2
141.17 144.88
143.03 2.623 2
127.36 164.68
146.02 26.389 2
211.71 133.42
172.57 55.359 2
5.57 5.51
5.54 0.042 2
4.68 7.26
5.97 1.824 2
7.91 6.19
7.05 1.216 2
4.31 4.10
4.21 0.148 2
3.06 3.91
3.49 0.601 2
1.98 1.97
1.98 0.007 2
1.51 1.83
1.67 0.226 2
5.89 3.90
4.90 1.407 2
1.92 1.80
1.86 0.085 2
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ANIMAL NUMBER
Appendix 6
Covance 6329-223 3M T-6295.7
Summary and Individual Blood Hormone Determination Day 546
26-WEEK CAPSULE TOXICITY STUDY WITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS;T-6295) IN CYNOMOLGUS MONKEYS
THYROID
TOTAL
FREE
TOTAL
FREE
CORTISOL TESTOSTERONE ESTRADIOL ESTRONE ESTRIOL STIMULATING TRIIODOTHYRONINE TRIIODOTHYRONINE THYROXIN THYROXIN
pg/dL
ng/mL
pg/mL
pg/mL pg/mL
/iU/mL
ng/dL
pg/mL
/Jg/dL
ng/dL
Group: Female 1
105529 105549
61.95 50.10
MEAN S.D. N
56.03 8.379 2
Group: Female 3
105539 105552
58.68 26.08
MEAN S.D. N
42.38 23.052
2
Group: Female 4
105533 105542
49.05 82.98
MEAN S.D. N
66.02 23.992
2
Dose Level : 0
Dosage Unit: mg/kg/day
0.32 0.15
88.86 55.18
60.95 29.70
0.00 0.00
2.28 2.86
0.24 0.120 2
72.02 23.815
2
45.33 22.097
2
0.00 0.000 2
2.57 0.410 2
Dose Level : 0.15
Dosage Unit: mg/kg/day
0.22 0.18
249.40 228.31
112.37 104.83
0.00 0.00
4.32 2.22
0.20 0.028 2
238.86 14.913 2
108.60 5.332 2
0.00 0.000 2
3.27 1.485 2
Dose Level : 0.75
Dosage Unit: mg/kg/day
0.73 0.40
89.07 94.97
85.47 46.34
0.00 0.00
3.89 4.50
0.57 0.233 2
92.02 4.172 2
65.91 27.669
2
0.00 0.000 2
4.20 0.431 2
113.93 122.28
118.11 5.904 2
133.88 194.67
164.28 42.985 2
122.53 131.85
127.19 6.590 2
4.61 4.59
4.60 0.014 2
QNS 7.69
7.69 1
4.63 4.36
4.50 0.191 2
4.23 4.96
4.60 0.516 2
1.65 1.91
1.78 0.184 2
3.65 6.48
5.07 2.001 2
1.63 1.81
1.72 0.127 2
3.41 3.46
3.44 0.035 2
1.41 1.31
1.36 0.071 2
003561
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APPENDIX 7 Cell Proliferation Report
Covance 6329-223 3M T-6295.7
Note: This appendix contains information supplied and audited by Pathology Associates International (PAI).
003562
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Covance 6329-223 3M T-6295.7
r
Pathology Associates International A Company of Science Applications International Corporation
M&nploy*OmdCempv\r
DRAFT CELL PROLIFERATION REPORT
26-W EEK CAPSULE TO XICITY STUDY W ITH PERFLUOROOCTANE SU LFO N IC ACID PO TASSIUM SALT (PFOS; T -6295) IN CYNOM OLGUS M O NK EYS COVANCE STUDY NUM BER 6329-223
PREPARED FOR: 3M
TOXICOLOGY SERVICES BUILDING 220-2E -02,3M CENTER
ST. PAUL, MN 55144-1000 PREPARED BY:
PATHOLOGY ASSOCIATES INTERNATIONAL 15 W ORM AN'S M ILL COURT, SUITE I FREDERICK, MD 21701
FEBRUARY 25,2000
15 W orm an's Mill Court, Suite I * Frederick, M aryland 21701 * (301) 663-1644 * (301) 663-8994 FAX
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WUVCU4W&
3M T-6295.7 Draft Cell Proliferation Report Covance Study Number 6329-223
Page 2
TABLE OF CONTENTS L CELL PROLIFERATION REPORT IL TABLES m . SIGNATURE PAGE IV . QUALITY ASSURANCE STAYEMENT V . APPENDIX I
810 0 0 3 5 6 4
3M T-6295.7 Draft Cell Proliferation Report Covance Study Number 6329-223
Page 3
CELL PROLIFERATION REPORT
26-W EEK CAPSULE TO XICITY STUDY W ITH PERFLUOROOCTANE SU LFO N IC ACID PO TA SSIU M SALT (PFOS; T-6295) IN CYNOM OLGUS M O NK EYS COVANCE STUDY NUM BER 6329-223
PURPOSE
The purpose o f title study was to assess the effect o f the test material on critical enzym e levels, hormones, and other selected biochem ical parameters when administered daily by capsule to cynomolgus m onkeys for at least 26 weeks.
This report, submitted by Pathology Associates International (PAI) to the study Sponsor, 3M , represents the cell proliferation findings and interpretation for Covance Study Number 6329-223 entitled " 26-W eek Capsule Toxicity Study with Perfluorooctane Sulfonic Acid Potassium Salt (PFOS; T-6295) in Cynomolgus Monkeys" . A ll aspects o f the tasks associated w ith PA I's portion o f this study were conducted in compliance with the Environmental Protection A gency Good Laboratory Practice (GLP) Regulations as set forth in Title 40 o f the U S Code o f Federal Regulations, Part 792, issued November 29, 1983 (effective December 29, 1983), and w ith any applicable amendments.
M ATERIALS AND M ETHODS
T issue C ollection for C ell Proliferation
Four animals per sex in groups 1 - 4 were sacrificed after at least 26 weeks on study. A representative sample o f the liver, testes (males only) and pancreas from each animal w as fixed in formalin, processed and embedded to paraffin block by Covance per protocol specifications. Tissue blocks were then shipped to PAI for sectioning and staining. From each block, a slide w as prepared for H&E evaluation and immunohistochemical detection o f proliferating cell nuclear antigen (PCNA), a marker o f cell proliferation.
Im m unohistochem istry for C ell Proliferation
Sections o f paraffin-embedded tissues were cut at approximately 5 pm and placed on positively charged slides (Superfrost Plus, Fisher Scientific, Pittsburgh, PA) to ensure adhesion during processing for PCNA. Standard immunohistochemical methods were used to stain tissues for PCNA (PAI's Standard Operating Procedure for Immunohistochemical Staining (SOP #707). Briefly, tissue sections were incubated with a monoclonal antibody to PCNA (DAKO, lot #107(101), PAI N o. A 2240) and reagents required for the avidin-biotin peroxidase (A BC Kit, lot #PK6102, PAI N o. K 444) method for the detection o f the antigen-antibody com plex. PCNA expression in cells was localized by the chromagen 3,3'-diaminobenzidine (D A B ; Sigma Chemical Co., lot #49H 8204 & 108H8210). Tissue sections were counterstained with hem atoxylin.
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________________ 3M T-6295.7 Draft Cell Proliferation Report
Covance Study Number 6329-223 Page 4
C ell Proliferation M easurem ents
The percentage o f hepatocytes in S-phase (labeling index, LI) was determined by scoring at least 3000 hepatocytes in 10 fields o f liver. The LI in the testes (males only) w as determined by scoring the number o f PCNA-positive Leydig cells among at least 100 L eydig cells. The labeling index in file pancreas was scored subjectively with 4 being both acinar and islets stained heavily and 3 being predominant staining in the acinar region. A negative control slide was included in the staining run and consisted o f study tissue that was not incubated with the primary antibody.
For cell proliferation evaluations, slides were first perused at low m agnification (100X ) to judge quality o f staining, processing and sectioning, potential patterns o f cellular proliferation, and histom orphologic changes. Cell proliferation was then quantified at higher m agnification (200X for liver and pancreas, and 400X for testes) as described above. H istom oiphology w as further assessed by evaluating the H&E slide prepared from the same tissue block for each animal evaluated for cell proliferation.
Statistical A nalysis
The Student's f-test (two-sided, unequal variance) was used to test for statistical significance in LI between control and treatment groups using M icrosoft Excel version 5 .0 . A P value o f 0.05 w as judged to be statistically significant.
RESULTS
C ell Proliferation
Individual animal cell proliferation data are presented in Section II (Table 1). C ell proliferation in the liver, testes and pancreas o f control and test material-treated animals w as sim ilar.
H istopathology
Sections from the same tissue blocks used for preparation o f PCNA-stained slides were stained with hem atoxylin and eosin (H&E) for histopathologic evaluation to facilitate the interpretation o f the immunostained slides. Individual animal findings are presented in Appendix I.
Single sections o f liver, pancreas, and testes from 16 adult male monkeys and single sections o f liver and pancreas from 16 adult fem ale monkeys representing control, low -dose (0.03 m g/kg/day), m id-dose (0.15 mg/kg/day) and high-dose (0.75 mg/kg/day) treatment groups were evaluated histologically. Each tissue section was stained with hem atoxylin and eosin. The purpose o f this evaluation was to determine whether or not morphologic changes were occurring in these tissues which may alter or confound the specificity o f the PCNA staining observed in these anim als.
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3M T-6295.7 Draft Cell Proliferation Report Covance Study Number 6329-223
PageS The results showed that no significant changes were observed in either the liver, pancreas, or testicular tissues from male monkeys or the liver and pancreas tissues from fem ale m onkeys, w hich would alter the interpretation o f the PCNA staining in this study. D IS C U SSIO N In the present study, cell proliferation was measured within the liver, testes and pancreas o f m ale m onkeys, and the liver and pancreas o f female monkeys from control (0 m g/kg/day), low dose (0.03 m g/kg/day), m id-dose (0.15 mg/kg/day) and high dose (0.75 m g/kg/day) groups after 26 w eeks on study to assess the effect o f the test material on critical enzyme levels, hormones, and other selected biological parameters, including cell proliferation. There did not appear to be a cell proliferative response to the test material in the liver, testes or pancreas, as determined by labeling indices, w hich were similar in all animals. SUM M ARY In the present study, cell proliferation, as determined by measuring the labeling index, w as not increased in the liver, testes or pancreas o f monkeys.
003567
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covante
3M T-6295.7 Draft Cell Proliferation Report Covance Study Number 6329-223
n . TABLE Legend
SEM = Standard Error o f the Mean
814 0 0 3 5 6 8
______________3M T-6295.7
C O V A N C E S TU D Y N O . 6329-223 T A B L E 1-1. C E L L P R O L IF E R A T IO N IN M O N K E Y S
A n im a l i L a b e lin g In d ex L a b e lin g In d e x L a b e lin g In d e x
D os G roup
S e x/G ro u p
Num ber
L iv e r
P a n c re a s
T estes
0 m g /kg /d ay (C ontrol) 0 m g /k g /d ay (C ontrol)
F/1 0 5 5 3 0 F/1 105531
0 .0 0 0 % ' 0 .0 2 7 % !
4 NP 3 NP
0 m g /kg /d ay (C ontrol)
1 F/1
1105535
0 .00 0% l
3 NP
0 m g /k g /d ay (C ontrol)
i F/1 j
I0 5 5 4 4 M ean
0 .1 9 9 % , 0.057% !
4 3 .5
NP
-
1 SEM
0 .048% i
0 .3
.
0 .0 3 m g /kg /d ay (Low dose) I
F /2
I0 5 5 3 7
0 .11 3%
3 NP
0 .0 3 m g /kg /d ay (Low dose) i
F /2
105541
0 .12 5%
4 NP
0 .0 3 m g /kg /d ay (Low dose)
i
F /2
105547
0 .000%
3 NP
0 .0 3 m g /kg /d ay (Low dose) !
F /2
I0 5 5 5 0
0 .212%
3 NP
1
M ean
0.11 2% )
3 .3
-
1 SEM
0 .04 4%
0 .3
-
0 .1 5 m g /kg /d ay (M id dose)
F /3 I0 5 5 3 2
0 .0 0 0 % l
3 NP
0 .1 5 m g /kg /d ay (M id dose)
F /3 I0 5 5 3 8
0 .08 6%
3 NP
0 .1 5 m g /kg /d ay (M id dose)
F /3 I0 5 5 4 5
0 .02 9%
3 NP
0 .1 5 m g /kg /d ay (M id dose)
F /3 I0 5 5 4 8
0 .12 0%
4 NP
M ean
0 .05 9%
3 .3
-
SEM
0 .027%
0 .3
-
0 .7 5 m g /kg /d ay (H igh dose)
F /4 I0 5 5 3 4
0 .00 0%
3 NP
0 .7 5 m g /kg /d ay (H igh dose)
F /4 I0 5 5 3 6
0 .313%
3 NP
0 .7 5 m g /kg /d ay (H igh dose)
F /4 1 05 5 4 0
0 .0 0 0 %
3 NP
0 .7 5 m g /kg /d ay (H ig h dose)
F /4 105551
0 .0 0 0 %
3 NP
M ean
0 .0 7 8 %
3 .0
-
SEM
0 .07 8%
0 .0
-
0 m g /k g /d ay (C o n tro l)
M /1 I0 5 5 0 8
0 .1 0 0 %
4 9 .5 2 %
0 m g /k g /d ay (C o n tro l)
M /1
105517
i
0 .06 2%
3 9 .0 0 %
0 m g /k g /d ay (C ontrol)
M /1 105519 T
0 .1 0 8 %
3 2 0 .7 5 %
0 m g /k g /d ay (C o n tro l)
M /1 I0 5 5 2 7
0 .4 6 4 % i
4 1 9.2 3%
M ean
0 .184%
3 .5 1 4.63%
SEM
0 .09 4%
0 .3 3 .1 2 %
0 .0 3 m g /kg /d ay (L o w dose)
M /2
105514
i
0 .0 9 5 %
3 1 6.3 6%
0 .0 3 m g /kg /d ay (L o w dose)
M /2 105515
0 .0 0 0 %
3 1 8 .5 2 %
0 .0 3 m g /kg /d ay (Lo w dose)
M /2
105516
!
0 .0 0 0 %
3 2 2 .9 5 %
0 .0 3 m g /kg /d ay (L o w dose)
M /2 105521
0 .0 0 0 %
4 1 2.3 8%
M ean
0 .0 2 4 %
3 .3 1 7 .5 5 %
SEM
0 .024%
0 .3 2 Ji0 %
0 .1 5 m g /kg /d ay (M id dose)
M /3 105510
0 .0 5 3 %
3 9 .1 7 %
0 .1 5 m g /kg /d ay (M id dose) 0 .1 5 m g /kg /d ay (M id dose)
M /3 105518 M /3 I0 5 5 2 4
0 .0 2 9 % J _ 0 .1 5 5 % !
4 1 7.1 4% 3 1 4.42%
0 .1 5 m g /kg /d ay (M id dose)
i
1
M /3
I0 5 5 2 8 M ean
0 .0 0 0 % ; 0 .05 9% I
4i 3 .5
1 0.71% 1 2.8 6%
SEM
0 .0 3 4 %
0.3 !
1 .8 0 %
0 .7 5 m g /kg /d ay (H igh dose)
M /4 105506
0 .030% !
3 7 .6 9 %
0 .7 5 m g /kg /d ay (H igh dose)
M /4 105507
0 .0 2 7 % :
3 1 9.6 1%
0 .7 5 m g /kg /d ay (H igh dose)
M /4 105509
NP'
NP
NP
0 .7 5 m g /kg /d ay (H igh dose) i M /4 j 105512
0 .0 0 0 % !
3 ND
M ean
0 .01 9% !
3.0 1 3 .6 5 %
;S E M
0 .00 9% !
0.0 5 .9 6 %
N D , not d eterm in ed due to suboptim al staining
j
N P , slide not p resen t
!
i
L iv e r P e rc e n ta g e o f hep ato cytes in S -p h a s e
i
P an cre a s: S co red subjectively w ith 4= is lets and a cin a r stain ed h eavily (> 5 0 % la b e le d ); 3 = a c in a r> is le ts
T e s te s : P e rc e n ta g e o f proliferating Leydig cells
P ag e 1-1
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v-ovauu:
3M T-6295.7
Draft Cell Proliferation Report Covance Study Number 6329-223
HI. SIGNATURE PAGE 26-W eek C apsule T oxicity Study w ith Perfluorooctane Sulfonic A cid P otassium Salt
(PFO S; T -6295) in Cynom olgus M onkeys (Covance Study N um ber 6329-223)
Submitted by:
PAI Project Manager:
Sandra R. Eldridge, Ph.D. PAI Project Pathologist:
Date
Carolyn M oyer, D .V .M ., Diplomate, A .C.V.P.
Date
816
003570
3M T-6295.7 Draft Cell Proliferation Report Covance Study Number 6329-223 IV. QUALITY ASSURANCE STATEM ENT
003571
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Pathology Associates international
A Com pany o f Science Applications International Corporation
3M T-6295.7
O tm tC en pu v
Cell Proliferation Report
26-Week Capsule Toxicity Study with Perfluorooctane Sulfonic Addi Potassium Salt (PFOS; T-6295) in Cynomolgus Monkeys
Covance Study Number: 6329-223
QUALITY ASSURANCE STATEMENT
This cell proliferation project has been inspected and audited by the PAI Quality Assurance U nit (Q AU) as required by the Good Laboratory Practice (GLP) regulations promulgated by the U .S. Environmental Protection Agency (TSCA). The cell proliferation report is an accurate reflection o f the recorded data. The follow ing table is a record o f the inspections/audits performed and reported by the QAU.
D ate of In sD ectio n
12/06/99 02/17/00
02/17/00
Phase InsDected
D ate Findings R eported to PAI M anaeem ent/Proiect M anaeer
Primary Antibody Dilution Study Data and Supporting Documentation Draft Cell Proliferation Report
12/06/99
02/17/00 02/17/00
Karen E. Butler Quality Assurance Officer
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1 5 W o rm a n 's M ill C o u rt, S u ite I F re d e ric k , M a ry la n d 2 1 7 0 1 (3 0 1 ) 6 6 3 -1 6 4 4 (3 0 1 ) 6 6 3 -8 9 9 4 F A X
Covance 6329-223 ________________ 3M T-6295.7
Draft Cell Proliferation Report Covance Study Number 6329-223
APPENDIX I
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Individual Animal Findings
3M T-6295.7
3MP #6329-223
26-WEEK CAPSULE TO XICITY STUDY W ITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T6295) IN CYNOMOLGUS MONKEYS
A N IM A L NUMBER
SEX DOSE GROUP
HISTO LOG IC FINDINGS
_______________________________________________________
105530 105531 105535 105544 105537 105541 105547 105550 105532 105538 105545 105548 105534 105536 105540 105551
F F F F F F F F F F F F F F F F
105517 105519 105527 105514 105515 105516 105521 105510
M M M M M M M M
1 Liver-NSF Pancreas - NSF
1 Liver-NSF Pancreas - NSF
1 Liver - chronic inflammation, minimal
Pancras - NSF 1 Liver-NSF
Pancreas - NSF
2 Liver-NSF Pancreas - NSF
2 Liver - chronic inflammation, minimal
Pancras - NSF 2 Liver-NSF
Pancreas - NSF 2 Liver-NSF
Pancreas - NSF 3 Liver - NSF
Pancreas - NSF 3 Liver - chronic inflammation, minimal
Pancreas - NSF 3 Liver - chronic inflammation, minimal
Pancreas - NSF 3 Liver - chronic inflammation, minimal
Pancras - NSF 4 Liver-NSF
Pancreas - NSF 4 Liver - fat infiltration, centrilobular, moderate
Pancreas - NSF 4 Liver - NSF
Pancreas - NSF 4 Liver-NSF
Pancreas - NSF
Liver - chronic inflammation, minir Pancreas - chronic inflammation, minimal Testes - NSF 1 Liver - NSF Pancreas - NSF Testes - crush artifact, focal 1 Liver - NSF Pancreas - NSF Testes - NSF
1 Liver-NSF Pancreas - NSF Testes - NSF
2 Liver - chronic inflammation, minimal Pancreas - chronic inflammation, minimal Testes - NSF
2 Liver - chronic inflammation, minimal Pancreas - NSF Testes - NSF
2 Liver-NSF Pancreas - NSF Testes - NSF
2 Liver-NSF Pancreas - NSF
Testes - NSF 3 Liver - chronic inflammation, minimal
Pancreas - NSF Testes - NSF
Legend: NSF = no significant findings
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Individual Animal Findings
v^ovance
3M T-6295.7
3MP #6329-223
26-WEEK CAPSULE TOXICITY STUDY W ITH PERFLUOROOCTANE SULFONIC ACID POTASSIUM SALT (PFOS; T629S) IN CYNOMOLGUS MONKEYS
A N IM A L NUMBER
SEX DOSE GROUP
HISTOLOGIC FINDINGS
105518 105524 105528 105507 105512 105506 105509
M M M M M M M
3 Liver-NSF Pancreas - NSF Testes - NSF
3 Liver-NSF Pancreas - NSF Testes - NSF
3 Liver-NSF Pancreas - NSF Testes - NSF
4 Liver - fat infiltration, centrilobular, moderate Pancreas - NSF T estes-N S F
4 Liver-NSF Pancreas - NSF Testes - NSF
4 Liver-NSF Pancreas - NSF Testes - NSF
4 No microscopic slides available. (Inventory shows blocks submitted; STPR does not show blocks sectioned.)
Legend: NSF = no significant findings
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