APPENDIX D SUMMARY OF LESIONS IN FEMALE MICE OF FUMONISIN B

D-1
APPENDIX D
SUMMARY OF LESIONS IN FEMALE MICE
IN THE 2-YEAR FEED STUDY
OF FUMONISIN B1
TABLE D1
TABLE D2
TABLE D3
TABLE D4
Board Draft
Summary of the Incidence of Neoplasms in Female Mice
in the 2-Year Feed Study of Fumonisin B1 . . . . . . . . . . . . . . . . . .
Individual Animal Tumor Pathology of Female Mice
in the 2-Year Feed Study of Fumonisin B1 . . . . . . . . . . . . . . . . . .
Statistical Analysis of Primary Neoplasms in Female Mice
in the 2-Year Feed Study of Fumonisin B1 . . . . . . . . . . . . . . . . . .
Summary of the Incidence of Nonneoplastic Lesions in Female Mice
in the 2-Year Feed Study of Fumonisin B1 . . . . . . . . . . . . . . . . . .
..............
D-2
..............
D-6
. . . . . . . . . . . . . . D-28
. . . . . . . . . . . . . . D-30
NOT FOR DISTRIBUTION OR ATTRIBUTION
D-2
Fumonisin B1, NTP TR 496
TABLE D1
Summary of the Incidence of Neoplasms in Female Mice in the 2-Year Feed Study of Fumonisin B1a
0 ppm
5 ppm
15 ppm
50 ppm
80 ppm
4
4
4
4
4
4
4
4
4
4
4
4
4
4
4
4
4
4
4
4
Animals initially in 2-year study
Early deaths
Removed from study
Moribund
Natural deaths
Survivors
Terminal sacrifice
Missing
48
48
48
48
48
4
7
1
3
1
2
3
6
6
14
35
1
44
46
39
28
Animals examined microscopically
63
64
64
64
64
Disposition Summary
3-Week evaluation
7-Week evaluation
9-Week evaluation
24-Week evaluation
Tissues Examined at 3 Weeks with No Neoplasms Observed
Kidney
Liver
Tissues Examined at 7 Weeks with No Neoplasms Observed
Eye
Heart
Kidney
Liver
Tissues Examined at 9 Weeks with No Neoplasms Observed
Intestine small
Kidney
Liver
Tissues Examined at 24 Weeks with No Neoplasms Observed
Kidney
Liver
Ovary
Oviduct
Thymus
Uterus
2-Year Study
Adrenal gland
Histio sarc
Histio sarc, metastatic, spleen
Lymph mal
Blood vessel, aorta
Lymph mal
Bone, femur
Lymph mal
(45)
(3)
(3)
1
(9)
(40)
(33%)
1
(43)
(47)
NOT FOR DISTRIBUTION OR ATTRIBUTION
(4)
(3)
(2)
(2)
3
(7)
1
(8)
(3%)
(33%)
(48)
(14%)
(47)
1
(2%)
Board Draft
Fumonisin B1, NTP TR 496
D-3
TABLE D1
Summary of the Incidence of Neoplasms in Female Mice in the 2-Year Feed Study of Fumonisin B1
0 ppm
5 ppm
15 ppm
50 ppm
(4)
(2)
(8)
(4)
(2)
1
(9)
1
80 ppm
2-Year Study (continued)
Bone marrow
Histio sarc
Lymph mal
Brain, cerebellum
Lymph mal
Meningioma mal
Brain, cerebrum
Lymph mal
Meningioma mal
Clitoral gland
Adenoma
Lymph mal
Ear
Lymph mal
Esophagus
Lymph mal
Eye
Lymph mal
Gallbladder
Lymph mal
Harderian gland
Adenoma
Carcinoma
Histio sarc
Lymph mal
Heart
Lymph mal
Intestine large, cecum
Lymph mal
Intestine large, colon
Lymph mal
Intestine large, rectum
Lymph mal
Intestine small, duodenum
Lymph mal
Intestine small, ileum
Lymph mal
Intestine small, jejunum
Lymph mal
Kidney
Histio sarc
Histio sarc, metastatic, spleen
Lymph mal
Lacrimal gland
Lymph mal
Liver
Hemangiosarc
Hepatoclr aden
Hepatoclr carc
Histio sarc
Histio sarc, metastatic, spleen
Lymph mal
Board Draft
(47)
1
2
(45)
1
(2%)
(4%)
(2%)
(47)
(34)
1
1
(46)
(46)
1
(45)
(42)
2
(46)
4
1
1
7
(47)
2
(47)
2
(47)
1
(47)
1
(47)
2
(47)
(4)
(2)
(9)
1
(3)
(3)
(2)
(4)
(2)
(2%)
(3)
(2)
(3)
(2)
(5%)
(9%)
(2%)
(2%)
(15%)
(13%)
(20%)
(3)
1
(33%)
1
(42)
(2%)
1
(47)
(2%)
2
(34)
(4%)
3
(41)
(9%)
(11%)
(11%)
(2)
(3%)
(3%)
(5)
1
(45)
1
(6)
1
(8)
3
(4)
1
(5)
1
(8)
2
(50%)
(38%)
(17%)
(38%)
(46)
1
(36)
(2%)
(26)
2
(44)
(8%)
(25%)
(20%)
(25%)
(4)
(2)
3
(9)
2
(6)
1
(5)
(4)
(2)
(6)
(35)
4
(36)
2
(34)
(3)
(2)
(5)
(34)
(3)
(2)
(6)
1
(5)
(4)
(2)
(3)
(2)
(4%)
(4%)
3
(47)
(7%)
(22%)
(17%)
(2%)
(11%)
(6%)
(2%)
(4%)
(47)
(3)
(47)
2
(48)
(3)
1
(48)
1
(4%)
13
(46)
14
(47)
1
5
(28%)
2
1
16
(4%)
(2%)
(34%)
8
(4)
(17%)
4
(1)
(2%)
(11%)
3
6
(13%)
(6%)
(48)
(42)
(2%)
(8%)
(48)
(6%)
(35)
2
(35)
(33%)
(30%)
(48)
(17%)
1
(2%)
1
(2%)
4
(8%)
(34%)
(21%)
1
13
(40)
9
(45)
2
31
9
(4%)
(69%)
(20%)
(2%)
(15%)
1
7
(2%)
(16%)
7
(7)
4
(47)
(15%)
16
10
1
7
(57%)
(2%)
(31%)
(23%)
NOT FOR DISTRIBUTION OR ATTRIBUTION
D-4
Fumonisin B1, NTP TR 496
TABLE D1
Summary of the Incidence of Neoplasms in Female Mice in the 2-Year Feed Study of Fumonisin B1
0 ppm
5 ppm
15 ppm
50 ppm
(4)
(2)
(9)
80 ppm
2-Year Study (continued)
Lung
Adenocarc, metastatic, mammary gland
Alv bron aden
Hepatoclr carc, metastatic, liver
Histio sarc
Histio sarc, metastatic, spleen
Lymph mal
Lymph mal hist
Squam cel carc, metastatic, skin
Lymph node
Lymph mal, lumbar
Lymph mal, renal
Squam cel carc, metastatic, axillary, skin
Lymph node, deep cervical
Lymph mal
Squam cel carc, metastatic, skin
Lymph node, mandibular
Lymph mal
Lymph mal hist
Squam cel carc, metastatic, skin
Lymph node, mesenteric
Histio sarc
Histio sarc, metastatic, spleen
Lymph mal
Lymph mal hist
Mammary gland
Adenocarc
Adenocarc, inguinal
Lymph mal
Nose
Adenoma, glands
Lymph mal
Ovary
Hemangioma
Histio sarc
Histio sarc, metastatic, spleen
Lymph mal
Lymph mal hist
Pancreas
Histio sarc, metastatic, spleen
Lymph mal
Salivary glands
Lymph mal
Lymph mal hist
Skeletal muscle
Lymph mal
Skin
Carc adenosqua
Fibrosarc
Lymph mal
Papilloma
Squam cel carc
Spinal cord, thoracic
Lymph mal
(47)
1
2
2
1
15
(47)
2
2
(46)
13
(2%)
(4%)
(4%)
(2%)
(32%)
1
5
1
(6)
(28%)
(2%)
(2%)
(36%)
(7)
(46)
1
(2%)
1
1
(1)
(17%)
1
(5)
1
(100%)
1
(5)
(20%)
1
(11%)
5
(46)
(11%)
(20%)
9
(20%)
(20%)
2
(40%)
(2)
1
(50%)
(15)
(5)
11
1
(23%)
(2%)
(4)
(45)
(50%)
(38%)
(9)
1
1
3
(9)
(11%)
(11%)
(33%)
3
(22)
1
(33%)
5
(23%)
(2)
2
(8)
4
(47)
(4)
(2)
(9)
(47)
1
1
(4)
(1)
(9)
(1)
1
(100%)
(44)
10
1
(23%)
(2%)
10
1
(38)
(26%)
(3%)
4
(48)
1
4
(42)
(11%)
1
11
1
(39)
1
4
(47)
12
1
(48)
1
(42)
(2%)
(26%)
(2%)
(5%)
(25%)
(50%)
(2%)
NOT FOR DISTRIBUTION OR ATTRIBUTION
(3%)
(10%)
(26%)
(2%)
(2%)
(22%)
1
(47)
1
(2%)
(8%)
(25%)
2
1
(4)
(2%)
(39)
3
(8)
(30%)
1
(4%)
(9%)
(8)
(2)
(2%)
(13%)
(2%)
(2%)
2
1
(8)
4
(5)
1
(2)
(15)
(2%)
(11%)
(56%)
(14%)
(3)
(4)
1
(11)
1
(20%)
(2)
5
(47)
(11%)
(25%)
(4%)
(4%)
(47)
1
1
17
(47)
1
6
(47)
14
1
(47)
(2%)
(25%)
(2)
(8)
1
(46)
(13%)
Board Draft
Fumonisin B1, NTP TR 496
D-5
TABLE D1
Summary of the Incidence of Neoplasms in Female Mice in the 2-Year Feed Study of Fumonisin B1
0 ppm
5 ppm
15 ppm
50 ppm
80 ppm
2-Year Study (continued)
Spleen
Hemangiosarc
Hemangiosarc, metastatic, liver
Histio sarc
Lymph mal
Stomach, forestomach
Lymph mal
Stomach, glandular
Lymph mal
Thymus
Lymph mal
Thyroid gland
Adenoma
Tongue
Lymph mal
Trachea
Lymph mal
Urinary bladder
Histio sarc
Lymph mal
Uterus
Hemangioma
Hemangiosarc
Histio sarc
Histio sarc, metastatic, spleen
Leiomyoma
Lymph mal
Polyp
Sarc stromal
Vagina
Histio sarc
Histio sarc, metastatic, spleen
Lymph mal
(47)
2
17
(46)
1
(46)
1
(37)
7
(46)
1
(47)
2
(43)
(45)
2
13
(47)
1
(10)
(4%)
(36%)
(13)
(4)
(2)
(3)
(1)
(4)
(2)
(3)
(1)
1
9
(9)
2
(6)
1
(5)
2
(7)
1
(9)
1
(5)
(4)
(2)
(8)
(38)
(32)
4
(38)
5
(4)
(50%)
1
9
(2)
(17)
(8%)
(69%)
(2%)
(4)
(2)
(2%)
(19%)
(2%)
(4%)
(4%)
(29%)
(6%)
(53%)
(42)
1
1
1
12
(43)
(2%)
(2%)
(2%)
(29%)
(22%)
(17%)
(40%)
(14%)
(39)
1
(34)
6
(41)
1
(46)
(3%)
(18%)
(2%)
(11%)
(38)
1
(35)
(50%)
(3%)
10
(42)
(29%)
(2%)
1
2
(4%)
1
2
(2%)
(4%)
(3%)
1
1
1
(3)
(47)
2
(4%)
3
(6%)
(3%)
4
1
(3%)
(8)
4
(2%)
1
(38)
(2%)
1
2
(3%)
(5%)
(11%)
(3%)
(3%)
(2)
1
(50%)
Neoplasm Summary
Total animals with primary neoplasmsb
2-Year study
Total primary neoplasms
2-Year study
Total animals with benign neoplasms
2-Year study
Total benign neoplasms
2-Year study
Total animals with malignant neoplasms
2-Year study
Total malignant neoplasms
2-Year study
Total animals with metastatic neoplasms
2-Year study
Total metastatic neoplasms
2-Year study
a
b
32
16
13
30
44
238
29
30
135
205
13
4
3
21
31
15
4
3
22
34
28
13
12
19
24
223
25
27
113
171
2
1
1
4
5
4
2
10
Number of animals examined microscopically at the site and the number of animals with neoplasm
Primary neoplasms: all neoplasms except metastatic neoplasms
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NOT FOR DISTRIBUTION OR ATTRIBUTION