APPENDIX C SUMMARY OF LESIONS IN MALE MICE OF FUMONISIN B

C-1
APPENDIX C
SUMMARY OF LESIONS IN MALE MICE
IN THE 2-YEAR FEED STUDY
OF FUMONISIN B1
TABLE C1
TABLE C2
TABLE C3
TABLE C4
Board Draft
Summary of the Incidence of Neoplasms in Male Mice
in the 2-Year Feed Study of Fumonisin B1 . . . . . . . . . . . . . . . .
Individual Animal Tumor Pathology of Male Mice
in the 2-Year Feed Study of Fumonisin B1 . . . . . . . . . . . . . . . .
Statistical Analysis of Primary Neoplasms in Male Mice
in the 2-Year Feed Study of Fumonisin B1 . . . . . . . . . . . . . . . .
Summary of the Incidence of Nonneoplastic Lesions in Male Mice
in the 2-Year Feed Study of Fumonisin B1 . . . . . . . . . . . . . . . .
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C-2
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C-6
. . . . . . . . . . . . . . . . C-26
. . . . . . . . . . . . . . . . C-28
NOT FOR DISTRIBUTION OR ATTRIBUTION
C-2
Fumonisin B1, NTP TR 496
TABLE C1
Summary of the Incidence of Neoplasms in Male Mice in the 2-Year Feed Study of Fumonisin B1a
0 ppm
5 ppm
15 ppm
80 ppm
150 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
48
48
48
48
48
4
3
1
3
5
1
2
5
6
4
2
41
39
45
37
42
Animals examined microscopically
64
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
Kidney
Liver
Preputial gland
Seminal vesicle
Tissues Examined at 9 and 24 Weeks with No Neoplasms Observed
Kidney
Liver
Preputial gland
2-Year Study
Adrenal gland
Lymph mal
Pheochrom bgn
Blood vessel, aorta
Lymph mal
Bone, femur
Histio sarc
Lymph mal
Bone, sternum
Histio sarc
Lymph mal
Bone marrow
Hemangiosarc, metastatic, spleen
Histio sarc
Lymph mal
Brain, cerebellum
Lymph mal
(46)
1
1
(46)
(8)
(1)
(9)
1
(9)
(48)
1
(47)
(2%)
1
(47)
(2%)
(3)
(11%)
(2)
(9)
1
(9)
(2)
(11%)
(2)
1
1
(47)
(9)
(48)
1
(2%)
(2%)
(2%)
NOT FOR DISTRIBUTION OR ATTRIBUTION
1
(8)
1
(11%)
(2)
(50%)
(11)
1
(11)
1
1
(11)
1
1
(11)
1
2
1
(8)
(2%)
(48)
(9%)
(48)
(9%)
(9%)
(9%)
(9%)
(9%)
(18%)
(9%)
2
(48)
(4%)
1
(47)
(2%)
1
2
(46)
(2%)
(4%)
(13%)
Board Draft
Fumonisin B1, NTP TR 496
C-3
TABLE C1
Summary of the Incidence of Neoplasms in Male Mice in the 2-Year Feed Study of Fumonisin B1
0 ppm
5 ppm
15 ppm
80 ppm
(9)
1
(7)
(2)
(10)
(1)
(10)
1
(9)
150 ppm
2-Year Study (continued)
Brain, cerebrum
Lymph mal
Coagulating gland
Lymph mal
Ear
Lymph mal
Epididymis
Adenoma, interstit cell
Histio sarc
Lymph mal
Eye
Lymph mal
Gallbladder
Lymph mal
Harderian gland
Adenoma
Carcinoma
Lymph mal
Heart
Lymph mal
Intestine large, cecum
Lymph mal
Intestine large, colon
Lymph mal
Intestine large, rectum
Lymph mal
Intestine small, ileum
Lymph mal
Kidney
Histio sarc
Lymph mal
Lacrimal gland
Lymph mal
Liver
Hemangiosarc
Hepatoclr aden
Hepatoclr carc
Histio sarc
Ito cl tm mal
Lymph mal
Lung
Adenocarc, multiple
Alv bron aden
Histio sarc
Lymph mal
Lymph node
Lymph mal, inguinal
Lymph node, mandibular
Fibrosarc, metastatic, skin
Histio sarc
Lymph mal
Lymph node, mesenteric
Histio sarc
Lymph mal
Board Draft
(47)
(46)
1
(45)
1
(48)
2
(44)
1
(40)
1
(46)
1
(2%)
(5)
(2)
(8)
(2)
1
9
4
1
(48)
6
(6)
(1)
(46)
1
(8)
1
1
(7)
(3)
(1)
(7)
1
(9)
(3%)
(48)
(13%)
(13%)
1
(45)
(2%)
(8)
(1)
(42)
(14%)
(44)
5
(2%)
(2%)
(1)
1
(11)
1
(6)
(6)
(1)
(8)
(8)
(1)
(7)
(6)
(1)
(7)
1
(47)
1
2
(8)
(9)
1
(5)
(11%)
(13%)
(3)
(11%)
(11%)
2
(48)
(5%)
(9%)
(46)
1
(46)
1
(47)
(2%)
(2%)
(2%)
(2%)
(48)
(2%)
2
(8)
(45)
(4%)
(2)
(14%)
(2%)
(4%)
(5%)
(19%)
(9%)
(2%)
(47)
1
7
3
1
1
(9)
(48)
(2%)
(15%)
(6%)
7
4
1
(15%)
(8%)
(2%)
(2%)
(2%)
(48)
1
6
3
2
1
(11)
(2)
(2%)
(13%)
(6%)
(4%)
(2%)
(13%)
1
3
(48)
(2%)
(2%)
(47)
1
(44)
2
(47)
(47)
1
(48)
(50%)
(4%)
(46)
(46)
1
(45)
1
(46)
(10%)
(2%)
1
1
(48)
(48)
(11%)
(6%)
1
(9)
(8)
(50%)
(2)
2
1
(15)
1
(10)
(3)
1
1
1
(15)
2
5
(11%)
(3)
(18%)
(9%)
(46)
1
(48)
3
(47)
1
(48)
8
2
1
4
(48)
1
6
1
2
(48)
(2%)
(6%)
(2%)
(17%)
(4%)
(2%)
(8%)
(2%)
(13%)
(2%)
(4%)
(7%)
(48)
(2%)
3
(48)
(7%)
4
(8%)
(7)
(33%)
(33%)
(10%)
(13%)
(33%)
1
3
(45)
1
5
(2%)
(6%)
(2%)
(11%)
NOT FOR DISTRIBUTION OR ATTRIBUTION
C-4
Fumonisin B1, NTP TR 496
TABLE C1
Summary of the Incidence of Neoplasms in Male Mice in the 2-Year Feed Study of Fumonisin B1
0 ppm
5 ppm
15 ppm
80 ppm
150 ppm
(1)
(10)
1
(48)
2-Year Study (continued)
Mammary gland
Lymph mal
Nose
Histio sarc
Lymph mal
Pancreas
Lymph mal
Peripheral nerve
Lymph mal
Preputial gland
Lymph mal
Prostate
Lymph mal
Salivary glands
Fibrosarc, metastatic, skin
Lymph mal
Seminal vesicle
Lymph mal
Skeletal muscle
Fibrosarc
Fibrosarc, metastatic, thoracic, skin
Skin
Fib histiocyt
Fibroma
Fibrosarc
Hemangioma
Lymph mal
Sarcoma
Squam cel carc
Spleen
Hemangiosarc
Histio sarc
Lymph mal
Stomach, forestomach
Lymph mal
Papilloma squa
Stomach, glandular
Adenocarc
Lymph mal
Testes
Histio sarc
Thymus
Lymph mal
Thyroid gland
Lymph mal
Trachea
Lymph mal
Urinary bladder
Lymph mal
Zymbal’s gland
Lymph mal
(4)
1
(48)
2
(47)
1
(46)
1
(46)
1
(46)
2
(48)
2
2
(46)
1
(47)
(2)
(25%)
(9)
(4%)
(1)
(8)
(3)
(9)
(4)
(17)
1
(10)
1
(10)
(2%)
(8)
(4%)
(11)
(4%)
(4%)
1
(8)
(1)
(9%)
1
(9)
1
(12)
1
(1)
(2%)
(9)
(10%)
1
(2%)
(2)
(11)
1
(9%)
1
1
(9%)
(9%)
1
(8)
(47)
(7)
(9%)
(9%)
(10%)
5
(6%)
(71%)
4
(47)
2
(46)
1
(46)
1
(47)
(10%)
(8%)
(4%)
(2%)
(2%)
(10%)
(48)
(10%)
5
(47)
(10%)
(11%)
(48)
(8%)
1
(47)
(14)
(2%)
1
4
(7%)
(29%)
5
(11%)
1
(7%)
1
(2%)
(9%)
(1)
(13)
1
2
3
(11)
1
1
(10)
(4%)
(7)
(1)
(2%)
(2%)
(7)
(2)
1
(48)
(8%)
(15%)
(23%)
1
6
(48)
(2%)
(13%)
(9%)
(9%)
(45)
(50%)
(2%)
(9)
(33)
(44)
(6)
1
(7)
(40)
(7)
(46)
3
(31)
(11%)
(2%)
5
1
(48)
(11)
1
1
(10)
1
(11)
(2%)
(48)
2
(47)
1
1
(45)
1
(8)
(1)
(1)
(2)
(17%)
(1)
(1)
(9)
(7%)
NOT FOR DISTRIBUTION OR ATTRIBUTION
(5)
(2)
(12)
1
(7)
1
(7)
1
(9)
1
(10)
1
(8)
1
(48)
(8%)
(14%)
(26)
2
(46)
(8%)
(14%)
(43)
(11%)
(10%)
(46)
4
(34)
(9%)
(13%)
Board Draft
Fumonisin B1, NTP TR 496
C-5
TABLE C1
Summary of the Incidence of Neoplasms in Male Mice in the 2-Year Feed Study of Fumonisin B1
0 ppm
5 ppm
15 ppm
80 ppm
150 ppm
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
24
16
16
21
27
73
30
23
71
91
15
8
8
8
17
18
8
8
8
19
13
10
11
16
16
55
22
15
63
72
2
1
1
3
1
1
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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