TDMS Study 05075-02 Pathology Tables
INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)
DIPHENYLHYDANTOIN
NTP Experiment-Test: 05075-02 Report: PEIRPT05
Study Type: CHRONIC Date: 09/09/94
Route: DOSED FEED Time: 15:42:01
Facility: Battelle Columbus Laboratory
Chemical CAS #: 57-41-0
Lock Date: None
Cage Range: All
Reasons For Removal: All
Removal Date Range: All
Treatment Groups: Include All
a Number of animals examined microscopically at site and number of animals with lesion
Page 1
NTP Experiment-Test: 05075-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC DIPHENYLHYDANTOIN Date: 09/09/94
Route: DOSED FEED Time: 15:42:01
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 PPM 0 PPM 60 PPM 200 PPM 200 PPM 200 PPM
0-0 10-0 1-1 10-3 3-3 0-3
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially in Study 50 50 50 50 50 50
Early Deaths
Natural Death 6 5 6 7 6 4
Moribund Sacrifice 8 11 9 6 6 8
Survivors
Terminal Sacrifice 36 34 35 37 38 38
Animals Examined Microscopically 50 50 50 50 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Gallbladder (45) (14) (14) (12) (11) (11)
Intestine Large, Cecum (46) (15) (20) (13) (10) (11)
Leiomyosarcoma 1 (8%)
Intestine Large, Colon (48) (16) (15) (13) (12) (11)
Leiomyoma 1 (2%)
Leiomyosarcoma 1 (8%)
Intestine Small, Ileum (46) (15) (14) (14) (11) (11)
Intestine Small, Jejunum (48) (16) (14) (15) (12) (11)
Adenocarcinoma 1 (8%)
Liver (48) (49) (50) (50) (50) (49)
Hemangiosarcoma 2 (4%) 2 (4%)
Hemangiosarcoma, Multiple 1 (2%)
Hepatocellular Carcinoma 1 (2%) 4 (8%) 4 (8%) 3 (6%) 1 (2%)
Hepatocellular Adenoma 5 (10%) 8 (16%) 10 (20%) 7 (14%) 20 (40%) 8 (16%)
Hepatocellular Adenoma, Multiple 3 (6%) 1 (2%) 5 (10%) 5 (10%) 5 (10%)
Mesentery (8) (2) (5) (4) (4) (2)
Pancreas (47) (15) (15) (12) (12) (11)
Salivary Glands (49) (15) (14) (14) (12) (11)
Stomach, Forestomach (48) (20) (20) (20) (12) (16)
Squamous Cell Papilloma 2 (4%) 3 (15%) 3 (15%) 2 (10%)
Squamous Cell Papilloma, Multiple 1 (5%)
Stomach, Glandular (48) (16) (16) (15) (11) (13)
Tongue (1)
Squamous Cell Carcinoma 1 (100%)
Tooth (5) (1) (1)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (50) (16) (15) (13) (12) (13)
____________________________________________________________________________________________________________________________________
Page 2
NTP Experiment-Test: 05075-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC DIPHENYLHYDANTOIN Date: 09/09/94
Route: DOSED FEED Time: 15:42:01
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 PPM 0 PPM 60 PPM 200 PPM 200 PPM 200 PPM
0-0 10-0 1-1 10-3 3-3 0-3
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Gland, Cortex (48) (16) (14) (13) (12) (11)
Adrenal Gland, Medulla (48) (16) (14) (13) (12) (11)
Pheochromocytoma Malignant 1 (2%)
Pheochromocytoma Complex 1 (2%)
Pheochromocytoma Benign 2 (4%) 2 (13%) 1 (7%) 1 (8%)
Islets, Pancreatic (47) (15) (14) (12) (11) (11)
Pituitary Gland (44) (19) (17) (17) (14) (15)
Pars Distalis, Adenoma 6 (14%) 8 (42%) 3 (18%) 2 (12%) 3 (21%) 8 (53%)
Pars Distalis, Carcinoma 1 (2%)
Pars Intermedia, Adenoma 1 (5%)
Thyroid Gland (47) (16) (15) (14) (12) (11)
C-Cell, Carcinoma 1 (7%)
Follicular Cell, Adenoma 4 (9%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Ovary (49) (28) (36) (28) (25) (30)
Choriocarcinoma 1 (4%)
Cystadenoma 1 (2%) 1 (3%) 3 (11%) 1 (4%) 1 (3%)
Granulosa Cell Tumor Benign 1 (2%)
Hemangioma 1 (4%)
Luteoma 1 (2%)
Periovarian Tissue, Hemangiosarcoma 1 (2%)
Uterus (49) (36) (31) (33) (33) (32)
Hemangiosarcoma 1 (3%)
Polyp Stromal 1 (2%) 1 (3%)
Sarcoma Stromal 1 (3%) 2 (6%)
Sarcoma Stromal, Multiple 1 (2%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Blood (2)
Bone Marrow (48) (16) (15) (13) (12) (11)
Femoral, Hemangiosarcoma 1 (2%) 2 (13%)
Lymph Node (50) (18) (16) (20) (15) (20)
Mandibular, Adenocarcinoma, Metastatic,
Harderian Gland 1 (5%)
Mediastinal, Alveolar/Bronchiolar Carcinoma,
Metastatic, Lung 1 (5%)
Page 3
NTP Experiment-Test: 05075-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC DIPHENYLHYDANTOIN Date: 09/09/94
Route: DOSED FEED Time: 15:42:01
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 PPM 0 PPM 60 PPM 200 PPM 200 PPM 200 PPM
0-0 10-0 1-1 10-3 3-3 0-3
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - cont
Mediastinal, Osteosarcoma, Metastatic,
Uncertain Primary Site 1 (5%)
Mediastinal, Mandibular, Sarcoma, Metastatic,
Eye 1 (6%)
Lymph Node, Mesenteric (12) (7) (5) (6) (4) (9)
Hemangiosarcoma 1 (14%)
Spleen (48) (23) (27) (23) (23) (27)
Hemangiosarcoma 3 (6%) 4 (17%)
Thymus (42) (12) (11) (9) (11) (10)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (46) (15) (12) (13) (9) (5)
Adenocarcinoma 1 (2%) 1 (7%) 2 (17%) 2 (15%)
Skin (49) (16) (17) (13) (12) (13)
Squamous Cell Carcinoma 1 (8%)
Subcutaneous Tissue, Fibrosarcoma 1 (2%) 1 (6%) 1 (6%) 1 (8%) 1 (8%)
Subcutaneous Tissue, Hemangiosarcoma 3 (19%)
Subcutaneous Tissue, Myxoma 1 (2%)
Subcutaneous Tissue, Myxosarcoma 1 (6%)
Subcutaneous Tissue, Sarcoma 1 (6%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (50) (16) (16) (13) (12) (12)
Femur, Osteoma 1 (6%)
Skeletal Muscle (1) (1)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (16) (15) (13) (13) (12)
Adenocarcinoma, Metastatic, Harderian Gland 1 (8%)
Carcinoma, Metastatic, Pituitary Gland 1 (2%)
Spinal Cord (1) (1)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (20) (20) (15) (13) (13)
Adenocarcinoma, Metastatic, Harderian Gland 1 (5%) 1 (8%)
Alveolar/Bronchiolar Adenoma 5 (10%) 2 (10%) 1 (5%) 2 (13%) 2 (15%)
Alveolar/Bronchiolar Carcinoma 1 (5%) 1 (5%) 1 (7%) 1 (8%) 1 (8%)
Hepatocellular Carcinoma, Metastatic, Liver 1 (5%) 2 (10%) 1 (8%)
Osteosarcoma, Metastatic, Uncertain Primary
Page 4
NTP Experiment-Test: 05075-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC DIPHENYLHYDANTOIN Date: 09/09/94
Route: DOSED FEED Time: 15:42:01
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 PPM 0 PPM 60 PPM 200 PPM 200 PPM 200 PPM
0-0 10-0 1-1 10-3 3-3 0-3
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM - cont
Site 1 (5%) 1 (8%)
Pheochromocytoma Malignant, Metastatic,
Adrenal Gland 1 (2%)
Sarcoma, Metastatic, Eye 1 (5%)
Mediastinum, Alveolar/Bronchiolar Carcinoma,
Metastatic, Lung 1 (8%)
Nose (50) (16) (15) (13) (12) (12)
Adenocarcinoma, Metastatic, Harderian Gland 1 (6%) 1 (8%)
Sarcoma, Metastatic, Eye 1 (7%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (2) (2) (1) (2) (1) (3)
Adenocarcinoma, Metastatic, Harderian Gland 1 (33%)
Sarcoma 1 (100%)
Harderian Gland (8) (4) (4) (3) (4) (4)
Adenocarcinoma 1 (13%) 3 (75%) 1 (33%) 1 (25%) 2 (50%)
Adenoma 3 (38%) 1 (25%) 2 (50%) 1 (33%) 3 (75%) 2 (50%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (48) (16) (16) (13) (14) (12)
Osteosarcoma, Metastatic, Uncertain Primary
Site 1 (8%)
Urinary Bladder (48) (15) (15) (13) (11) (11)
____________________________________________________________________________________________________________________________________
SYSTEMIC LESIONS
Multiple Organs *(50) *(50) *(50) *(50) *(50) *(50)
Lymphoma Malignant Histiocytic 5 (10%) 3 (6%) 6 (12%) 4 (8%) 2 (4%)
Lymphoma Malignant Lymphocytic 9 (18%) 2 (4%) 2 (4%) 1 (2%)
Lymphoma Malignant Mixed 9 (18%) 8 (16%) 3 (6%) 11 (22%) 10 (20%) 12 (24%)
Lymphoma Malignant Undifferentiated Cell 1 (2%) 2 (4%)
____________________________________________________________________________________________________________________________________
* Number of animals with any tissue examined microscopically
Page 5
NTP Experiment-Test: 05075-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC DIPHENYLHYDANTOIN Date: 09/09/94
Route: DOSED FEED Time: 15:42:01
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 PPM 0 PPM 60 PPM 200 PPM 200 PPM 200 PPM
0-0 10-0 1-1 10-3 3-3 0-3
____________________________________________________________________________________________________________________________________
TUMOR SUMMARY
Total Animals with Primary Neoplasms (b) 40 36 27 36 39 36
Total Primary Neoplasms 69 65 47 50 55 47
Total Animals with Benign Neoplasms 23 22 18 22 29 24
Total Benign Neoplasms 33 28 23 25 33 26
Total Animals with Malignant Neoplasms 29 28 21 23 21 20
Total Malignant Neoplasms 36 37 24 25 22 21
Total Animals with Metastatic Neoplasms 2 2 4 1 4
Total Metastatic Neoplasm 2 3 6 1 10
Total Animals with Malignant Neoplasms 1 1
Uncertain Primary Site
Total Animals with Neoplasms Uncertain-
Benign or Malignant
Total Uncertain Neoplasms
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
b Primary tumors: all tumors except metastatic tumors
Page 6
NTP Experiment-Test: 05075-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC DIPHENYLHYDANTOIN Date: 09/09/94
Route: DOSED FEED Time: 15:42:01
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 600 PPM 600 PPM
10-10 0-10
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially in Study 50 50
Early Deaths
Natural Death 4 5
Moribund Sacrifice 6 8
Survivors
Terminal Sacrifice 40 37
Animals Examined Microscopically 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Gallbladder (45) (45)
Intestine Large, Rectum (50) (47)
Intestine Small, Duodenum (49) (48)
Intestine Small, Jejunum (48) (48)
Liver (50) (50)
Hepatoblastoma 1 (2%)
Hepatocellular Carcinoma 10 (20%) 9 (18%)
Hepatocellular Carcinoma, Multiple 2 (4%)
Hepatocellular Adenoma 19 (38%) 16 (32%)
Hepatocellular Adenoma, Multiple 7 (14%) 6 (12%)
Mesentery (6) (6)
Pancreas (49) (48)
Salivary Glands (50) (49)
Stomach, Forestomach (49) (48)
Mast Cell Tumor NOS 1 (2%)
Stomach, Glandular (49) (48)
Mast Cell Tumor NOS 1 (2%)
Tooth (12) (9)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (50) (50)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Gland, Cortex (50) (48)
Adrenal Gland, Medulla (50) (48)
Pheochromocytoma Malignant 1 (2%)
Pheochromocytoma Benign 2 (4%)
Pituitary Gland (44) (41)
Pars Distalis, Adenoma 3 (7%) 3 (7%)
Page 7
NTP Experiment-Test: 05075-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC DIPHENYLHYDANTOIN Date: 09/09/94
Route: DOSED FEED Time: 15:42:01
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 600 PPM 600 PPM
10-10 0-10
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM - cont
Thyroid Gland (49) (50)
Follicular Cell, Adenoma 4 (8%) 2 (4%)
Follicular Cell, Adenoma, Multiple 2 (4%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Ovary (50) (49)
Cystadenoma 1 (2%) 2 (4%)
Luteoma 1 (2%)
Teratoma 1 (2%)
Uterus (50) (50)
Adenocarcinoma 1 (2%)
Polyp Stromal 1 (2%)
Vagina (1)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Blood (3) (1)
Bone Marrow (49) (50)
Lymph Node (48) (49)
Lymph Node, Mesenteric (6) (6)
Spleen (50) (48)
Thymus (42) (45)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (39) (40)
Skin (49) (50)
Subcutaneous Tissue, Fibrosarcoma 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Skeletal Muscle (1)
____________________________________________________________________________________________________________________________________
Page 8
NTP Experiment-Test: 05075-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC DIPHENYLHYDANTOIN Date: 09/09/94
Route: DOSED FEED Time: 15:42:01
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 600 PPM 600 PPM
10-10 0-10
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (49)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (50)
Alveolar/Bronchiolar Adenoma 1 (2%) 2 (4%)
Hepatocellular Carcinoma, Metastatic, Liver 2 (4%) 2 (4%)
Osteosarcoma, Metastatic, Uncertain Primary
Site 1 (2%)
Mediastinum, Hepatocellular Carcinoma,
Metastatic, Liver 1 (2%)
Trachea (49) (50)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Harderian Gland (2)
Adenoma 1 (50%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (50)
Urinary Bladder (49) (49)
____________________________________________________________________________________________________________________________________
SYSTEMIC LESIONS
Multiple Organs *(50) *(50)
Lymphoma Malignant Histiocytic 4 (8%) 6 (12%)
Lymphoma Malignant Lymphocytic 3 (6%) 5 (10%)
Lymphoma Malignant Mixed 5 (10%) 4 (8%)
Lymphoma Malignant Undifferentiated Cell 1 (2%)
____________________________________________________________________________________________________________________________________
* Number of animals with any tissue examined microscopically
Page 9
NTP Experiment-Test: 05075-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC DIPHENYLHYDANTOIN Date: 09/09/94
Route: DOSED FEED Time: 15:42:01
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 600 PPM 600 PPM
10-10 0-10
____________________________________________________________________________________________________________________________________
TUMOR SUMMARY
Total Animals with Primary Neoplasms (b) 46 42
Total Primary Neoplasms 64 65
Total Animals with Benign Neoplasms 33 28
Total Benign Neoplasms 39 35
Total Animals with Malignant Neoplasms 21 26
Total Malignant Neoplasms 23 30
Total Animals with Metastatic Neoplasms 3 3
Total Metastatic Neoplasm 3 3
Total Animals with Malignant Neoplasms 1
Uncertain Primary Site
Total Animals with Neoplasms Uncertain-
Benign or Malignant 1
Total Uncertain Neoplasms 2
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
b Primary tumors: all tumors except metastatic tumors
Page 10
NTP Experiment-Test: 05075-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC DIPHENYLHYDANTOIN Date: 09/09/94
Route: DOSED FEED Time: 15:42:01
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 PPM O PPM 30 PPM 100 PPM 100 PPM 100 PPM
0-0 10-0 1-1 10-3 3-3 0-3
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially in Study 50 50 50 50 50 50
Early Deaths
Moribund Sacrifice 6 8 2 7 10 3
Natural Death 5 5 9 6 7 6
Survivors
Terminal Sacrifice 38 36 38 36 33 39
Moribund Sacrifice 1
Natural Death 1 1 1
Missing 1 1
Animals Examined Microscopically 50 50 50 49 50 49
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Gallbladder (46) (11) (8) (11) (10) (5)
Intestine Large, Rectum (47) (13) (11) (12) (15) (8)
Intestine Small, Duodenum (48) (12) (9) (10) (15) (7)
Intestine Small, Ileum (48) (11) (13) (11) (14) (6)
Intestine Small, Jejunum (50) (12) (17) (10) (16) (8)
Liver (50) (50) (50) (49) (50) (49)
Cholangiocarcinoma 1 (2%)
Hemangiosarcoma 4 (8%) 1 (2%) 1 (2%)
Hemangiosarcoma, Multiple 1 (2%) 2 (4%) 4 (8%) 1 (2%) 1 (2%)
Hepatoblastoma 1 (2%) 1 (2%)
Hepatoblastoma, Multiple 1 (2%)
Hepatocellular Carcinoma 11 (22%) 10 (20%) 11 (22%) 11 (22%) 14 (28%) 11 (22%)
Hepatocellular Carcinoma, Multiple 2 (4%) 4 (8%) 2 (4%) 7 (14%) 4 (8%) 3 (6%)
Hepatocellular Adenoma 14 (28%) 11 (22%) 10 (20%) 10 (20%) 15 (30%) 11 (22%)
Hepatocellular Adenoma, Multiple 5 (10%) 12 (24%) 6 (12%) 13 (27%) 5 (10%) 8 (16%)
Hepatocholangiocarcinoma 1 (2%)
Osteosarcoma, Metastatic, Uncertain Primary
Site 1 (2%)
Mesentery (3) (2) (2) (3)
Hepatocholangiocarcinoma, Metastatic 1 (50%)
Sarcoma 1 (50%)
Pancreas (50) (13) (11) (13) (17) (8)
Sarcoma, Metastatic, Mesentery 1 (9%)
Salivary Glands (50) (13) (12) (13) (17) (9)
Stomach, Forestomach (50) (16) (11) (18) (15) (9)
Squamous Cell Papilloma 2 (13%) 2 (13%)
Stomach, Glandular (50) (15) (9) (16) (13) (9)
Adenoma 1 (11%)
Tongue (1)
Squamous Cell Carcinoma 1 (100%)
Page 11
NTP Experiment-Test: 05075-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC DIPHENYLHYDANTOIN Date: 09/09/94
Route: DOSED FEED Time: 15:42:01
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 PPM O PPM 30 PPM 100 PPM 100 PPM 100 PPM
0-0 10-0 1-1 10-3 3-3 0-3
____________________________________________________________________________________________________________________________________
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (50) (14) (12) (13) (17) (10)
Alveolar/Bronchiolar Carcinoma, Metastatic,
Lung 1 (8%)
Cholangiocarcinoma, Metastatic, Liver 1 (8%)
Hemangiosarcoma 1 (2%) 2 (15%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Gland (50) (14) (11) (12) (17) (9)
Corticomedullary Junction, Hepatocellular
Carcinoma, Metastatic, Liver 1 (2%)
Adrenal Gland, Cortex (50) (14) (11) (12) (17) (9)
Adenoma 1 (7%)
Adrenal Gland, Medulla (50) (14) (11) (11) (17) (9)
Pheochromocytoma Benign 1 (2%)
Islets, Pancreatic (50) (13) (10) (12) (17) (8)
Adenoma 1 (2%)
Pituitary Gland (45) (11) (4) (10) (14) (7)
Pars Distalis, Carcinoma 1 (25%)
Pars Intermedia, Carcinoma 1 (10%)
Thyroid Gland (49) (14) (11) (13) (17) (9)
Follicular Cell, Adenoma 1 (7%) 1 (9%) 1 (11%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Preputial Gland (5) (2) (4) (2) (3) (8)
Adenoma 1 (20%)
Hemangiosarcoma 1 (13%)
Prostate (50) (14) (12) (13) (17) (9)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (50) (14) (11) (13) (18) (9)
Femoral, Hemangiosarcoma 2 (4%)
Lymph Node (50) (30) (32) (27) (31) (23)
Deep Cervical, Carcinoma, Metastatic, Ear 1 (3%)
Page 12
NTP Experiment-Test: 05075-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC DIPHENYLHYDANTOIN Date: 09/09/94
Route: DOSED FEED Time: 15:42:01
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 PPM O PPM 30 PPM 100 PPM 100 PPM 100 PPM
0-0 10-0 1-1 10-3 3-3 0-3
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - cont
Mandibular, Fibrosarcoma, Metastatic, Skin 1 (2%)
Mediastinal, Alveolar/Bronchiolar Carcinoma,
Metastatic, Lung 1 (4%)
Mediastinal, Cholangiocarcinoma, Metastatic,
Liver 1 (3%)
Lymph Node, Mesenteric (22) (22) (20) (16) (20) (15)
Hemangiosarcoma 1 (5%) 1 (7%)
Spleen (49) (21) (18) (20) (25) (17)
Hemangiosarcoma 4 (8%) 2 (10%) 3 (15%)
Thymus (37) (8) (7) (7) (10) (7)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Skin (50) (15) (13) (14) (20) (9)
Squamous Cell Carcinoma 1 (7%)
Subcutaneous Tissue, Fibroma 2 (13%)
Subcutaneous Tissue, Fibrosarcoma 1 (2%) 1 (7%) 1 (7%) 1 (5%) 1 (11%)
Subcutaneous Tissue, Lipoma 1 (8%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (50) (30) (40) (30) (37) (35)
Osteosarcoma 1 (3%)
Skeletal Muscle (1) (1) (1)
Hemangiosarcoma 1 (100%) 1 (100%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (14) (12) (13) (18) (10)
Carcinoma, Metastatic, Pituitary Gland 1 (8%) 1 (8%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (19) (19) (21) (20) (22)
Adenocarcinoma, Metastatic, Harderian Gland 1 (5%)
Alveolar/Bronchiolar Adenoma 6 (12%) 8 (42%) 5 (26%) 5 (24%) 3 (15%) 2 (9%)
Alveolar/Bronchiolar Carcinoma 4 (8%) 3 (16%) 2 (11%) 3 (14%) 1 (5%) 6 (27%)
Alveolar/Bronchiolar Carcinoma, Multiple 2 (11%) 2 (11%) 1 (5%) 1 (5%) 3 (14%)
Carcinoma, Metastatic, Ear 1 (5%)
Cholangiocarcinoma, Metastatic, Liver 1 (5%)
Hepatocellular Carcinoma, Metastatic, Liver 6 (12%) 2 (11%) 3 (16%) 5 (24%) 4 (20%) 2 (9%)
Hepatocholangiocarcinoma, Metastatic 1 (5%)
Osteosarcoma, Metastatic, Uncertain Primary
Page 13
NTP Experiment-Test: 05075-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC DIPHENYLHYDANTOIN Date: 09/09/94
Route: DOSED FEED Time: 15:42:01
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 PPM O PPM 30 PPM 100 PPM 100 PPM 100 PPM
0-0 10-0 1-1 10-3 3-3 0-3
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM - cont
Site 1 (5%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Ear (1)
Basal Cell Carcinoma 1 (100%)
Harderian Gland (9) (2) (2) (2) (3) (4)
Adenocarcinoma 1 (11%) 1 (50%) 1 (33%)
Adenoma 5 (56%) 2 (100%) 1 (50%) 1 (50%) 2 (67%) 4 (100%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (16) (12) (13) (18) (9)
Hepatocellular Carcinoma, Metastatic, Liver 1 (2%) 1 (8%)
Osteosarcoma, Metastatic, Uncertain Primary
Site 1 (11%)
Sarcoma, Metastatic, Mesentery 1 (8%)
Renal Tubule, Carcinoma 1 (6%)
____________________________________________________________________________________________________________________________________
SYSTEMIC LESIONS
Multiple Organs *(50) *(50) *(50) *(49) *(50) *(49)
Lymphoma Malignant Histiocytic 2 (4%) 2 (4%) 1 (2%) 2 (4%) 4 (8%) 2 (4%)
Lymphoma Malignant Lymphocytic 5 (10%) 2 (4%) 2 (4%)
Lymphoma Malignant Mixed 5 (10%) 8 (16%) 5 (10%) 3 (6%) 5 (10%) 5 (10%)
Lymphoma Malignant Undifferentiated Cell 1 (2%)
____________________________________________________________________________________________________________________________________
* Number of animals with any tissue examined microscopically
Page 14
NTP Experiment-Test: 05075-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC DIPHENYLHYDANTOIN Date: 09/09/94
Route: DOSED FEED Time: 15:42:01
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 PPM O PPM 30 PPM 100 PPM 100 PPM 100 PPM
0-0 10-0 1-1 10-3 3-3 0-3
____________________________________________________________________________________________________________________________________
TUMOR SUMMARY
Total Animals with Primary Neoplasms (b) 43 43 33 42 45 39
Total Primary Neoplasms 77 79 53 70 64 63
Total Animals with Benign Neoplasms 25 32 20 26 24 22
Total Benign Neoplasms 33 39 24 29 27 27
Total Animals with Malignant Neoplasms 29 31 24 29 34 31
Total Malignant Neoplasms 44 40 29 41 37 36
Total Animals with Metastatic Neoplasms 7 4 7 6 5 3
Total Metastatic Neoplasm 9 6 10 8 5 5
Total Animals with Malignant Neoplasms 1
Uncertain Primary Site
Total Animals with Neoplasms Uncertain-
Benign or Malignant
Total Uncertain Neoplasms
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
b Primary tumors: all tumors except metastatic tumors
Page 15
NTP Experiment-Test: 05075-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC DIPHENYLHYDANTOIN Date: 09/09/94
Route: DOSED FEED Time: 15:42:01
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 300 PPM 300 PPM
10-10 0-10
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially in Study 50 50
Early Deaths
Moribund Sacrifice 4 9
Natural Death 2 7
Survivors
Terminal Sacrifice 44 34
Animals Examined Microscopically 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Gallbladder (44) (46)
Intestine Large, Cecum (47) (47)
Intestine Large, Colon (48) (50)
Intestine Small, Duodenum (49) (48)
Intestine Small, Ileum (49) (46)
Intestine Small, Jejunum (48) (48)
Liver (50) (49)
Hemangiosarcoma 1 (2%) 1 (2%)
Hemangiosarcoma, Multiple 2 (4%)
Hepatocellular Carcinoma 18 (36%) 7 (14%)
Hepatocellular Carcinoma, Multiple 2 (4%)
Hepatocellular Adenoma 12 (24%) 11 (22%)
Hepatocellular Adenoma, Multiple 19 (38%) 11 (22%)
Sarcoma, Metastatic, Uncertain Primary Site 1 (2%)
Mesentery (3) (4)
Sarcoma, Metastatic, Uncertain Primary Site 1 (33%)
Pancreas (49) (49)
Tooth (44) (39)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (50) (49)
Hepatocellular Carcinoma, Metastatic, Liver 1 (2%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Gland (49) (48)
Capsule, Adenoma 1 (2%)
Adrenal Gland, Cortex (49) (49)
Adrenal Gland, Medulla (49) (45)
Pheochromocytoma Benign 1 (2%)
Page 16
NTP Experiment-Test: 05075-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC DIPHENYLHYDANTOIN Date: 09/09/94
Route: DOSED FEED Time: 15:42:01
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 300 PPM 300 PPM
10-10 0-10
____________________________________________________________________________________________________________________________________
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Prostate (50) (50)
Testes (50) (50)
Interstitial Cell, Adenoma 2 (4%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (50) (50)
Femoral, Mast Cell Tumor NOS 1 (2%)
Lymph Node (50) (47)
Lymph Node, Mesenteric (18) (24)
Sarcoma, Metastatic, Uncertain Primary Site 1 (6%)
Spleen (49) (47)
Hemangiosarcoma 2 (4%)
Thymus (43) (41)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Skin (50) (50)
Subcutaneous Tissue, Fibrous Histiocytoma 1 (2%)
Subcutaneous Tissue, Hemangiosarcoma 1 (2%)
Subcutaneous Tissue, Sarcoma 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
None
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
None
____________________________________________________________________________________________________________________________________
Page 17
NTP Experiment-Test: 05075-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC DIPHENYLHYDANTOIN Date: 09/09/94
Route: DOSED FEED Time: 15:42:01
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 300 PPM 300 PPM
10-10 0-10
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (49)
Adenocarcinoma, Metastatic, Harderian Gland 1 (2%)
Alveolar/Bronchiolar Adenoma 7 (14%) 4 (8%)
Alveolar/Bronchiolar Carcinoma 4 (8%) 2 (4%)
Hepatocellular Carcinoma, Metastatic, Liver 7 (14%) 1 (2%)
Sarcoma, Metastatic, Uncertain Primary Site 1 (2%)
Mediastinum, Hepatocellular Carcinoma,
Metastatic, Liver 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Harderian Gland (4) (5)
Adenocarcinoma 1 (20%)
Adenoma 3 (75%) 3 (60%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (50)
____________________________________________________________________________________________________________________________________
SYSTEMIC LESIONS
Multiple Organs *(50) *(50)
Lymphoma Malignant Histiocytic 3 (6%)
Lymphoma Malignant Lymphocytic 3 (6%) 3 (6%)
Lymphoma Malignant Mixed 3 (6%) 2 (4%)
____________________________________________________________________________________________________________________________________
* Number of animals with any tissue examined microscopically
Page 18
NTP Experiment-Test: 05075-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC DIPHENYLHYDANTOIN Date: 09/09/94
Route: DOSED FEED Time: 15:42:01
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 300 PPM 300 PPM
10-10 0-10
____________________________________________________________________________________________________________________________________
TUMOR SUMMARY
Total Animals with Primary Neoplasms (b) 45 36
Total Primary Neoplasms 79 53
Total Animals with Benign Neoplasms 36 26
Total Benign Neoplasms 41 33
Total Animals with Malignant Neoplasms 26 16
Total Malignant Neoplasms 37 20
Total Animals with Metastatic Neoplasms 9 2
Total Metastatic Neoplasm 13 2
Total Animals with Malignant Neoplasms 1
Uncertain Primary Site
Total Animals with Neoplasms Uncertain-
Benign or Malignant 1
Total Uncertain Neoplasms 1
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
b Primary tumors: all tumors except metastatic tumors
Page 19
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