TDMS Study 05075-01 Pathology Tables
INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)
DIPHENYLHYDANTOIN
NTP Experiment-Test: 05075-01 Report: PEIRPT05
Study Type: CHRONIC Date: 09/09/94
Route: DOSED FEED Time: 09:05:50
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: 05075-01 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: 09:05:50
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 PPM 0 PPM 240 PPM 800 PPM 800 PPM 800 PPM
0-0 10-0 1-1 0-3 3-3 10-3
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially in Study 50 50 50 50 50 50
Early Deaths
Moribund Sacrifice 17 19 19 9 19 15
Natural Death 2 2 4 4 2 2
Survivors
Terminal Sacrifice 31 29 27 37 28 33
Moribund Sacrifice 1
Animals Examined Microscopically 50 50 50 50 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Esophagus (50) (21) (22) (13) (22) (17)
Intestine Large, Cecum (48) (20) (20) (9) (19) (16)
Intestine Large, Colon (49) (20) (20) (10) (20) (16)
Intestine Large, Rectum (49) (20) (20) (9) (20) (16)
Intestine Small, Duodenum (49) (20) (20) (10) (20) (16)
Intestine Small, Ileum (49) (20) (20) (9) (20) (15)
Intestine Small, Jejunum (49) (20) (20) (9) (20) (17)
Adenocarcinoma 1 (6%)
Liver (50) (49) (50) (50) (50) (50)
Hepatocellular Adenoma 1 (2%)
Hepatocellular Adenoma, Multiple 1 (2%)
Mesentery (3) (6) (3) (1) (1) (2)
Pancreas (50) (20) (23) (10) (21) (16)
Salivary Glands (50) (21) (22) (12) (22) (17)
Carcinoma, Metastatic 1 (5%)
Stomach, Forestomach (49) (20) (23) (11) (22) (16)
Stomach, Glandular (49) (20) (20) (11) (20) (16)
Tongue (1)
Squamous Cell Carcinoma 1 (100%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (50) (21) (24) (13) (22) (17)
Endocardium, Schwannoma Benign 1 (5%)
Pericardium, Alveolar/Bronchiolar Carcinoma,
Metastatic, Lung 1 (6%)
____________________________________________________________________________________________________________________________________
Page 2
NTP Experiment-Test: 05075-01 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: 09:05:50
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 PPM 0 PPM 240 PPM 800 PPM 800 PPM 800 PPM
0-0 10-0 1-1 0-3 3-3 10-3
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Gland, Cortex (50) (21) (23) (13) (20) (17)
Adenoma 2 (4%)
Carcinoma 1 (6%)
Adrenal Gland, Medulla (49) (21) (23) (13) (22) (17)
Pheochromocytoma Malignant 1 (5%)
Pheochromocytoma Benign 4 (8%) 1 (5%) 1 (5%) 1 (6%)
Islets, Pancreatic (50) (20) (23) (11) (21) (16)
Adenoma 1 (2%) 1 (5%) 1 (4%) 1 (9%)
Pituitary Gland (50) (41) (43) (32) (35) (33)
Pars Distalis, Adenoma 25 (50%) 26 (63%) 15 (35%) 19 (59%) 15 (43%) 13 (39%)
Pars Distalis, Carcinoma 1 (2%) 1 (3%)
Thyroid Gland (48) (20) (19) (9) (20) (17)
Bilateral, C-Cell, Adenoma 1 (2%) 1 (5%)
C-Cell, Adenoma 12 (25%) 7 (35%) 4 (21%) 1 (11%) 3 (15%) 2 (12%)
C-Cell, Carcinoma 2 (4%)
Follicular Cell, Adenocarcinoma 1 (2%) 1 (5%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Clitoral Gland (45) (21) (24) (14) (24) (20)
Adenoma 4 (9%) 4 (17%) 2 (14%) 4 (17%)
Carcinoma 2 (4%) 1 (5%)
Squamous Cell Papilloma 1 (7%)
Ovary (49) (23) (26) (19) (26) (21)
Uterus (50) (26) (26) (25) (35) (31)
Adenocarcinoma 1 (3%) 1 (3%)
Leiomyoma 1 (3%)
Leiomyosarcoma 1 (2%) 1 (4%)
Polyp Stromal 6 (12%) 4 (15%) 6 (23%) 11 (44%) 13 (37%) 11 (35%)
Polyp Stromal, Multiple 1 (4%)
Sarcoma Stromal 1 (4%) 1 (4%) 1 (3%) 1 (3%)
Cervix, Carcinoma Adenosquamous 1 (3%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (50) (21) (22) (12) (22) (17)
Lymph Node (49) (21) (26) (12) (23) (22)
Deep Cervical, Carcinoma, Metastatic,
Thyroid Gland 1 (2%)
Page 3
NTP Experiment-Test: 05075-01 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: 09:05:50
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 PPM 0 PPM 240 PPM 800 PPM 800 PPM 800 PPM
0-0 10-0 1-1 0-3 3-3 10-3
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - cont
Lymph Node, Mesenteric (1) (1) (4) (1) (6) (6)
Spleen (50) (26) (29) (17) (22) (21)
Hemangioma 1 (3%)
Thymus (46) (18) (21) (12) (19) (17)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (50) (24) (31) (19) (25) (23)
Adenocarcinoma 3 (6%) 3 (13%) 2 (11%)
Adenoma 1 (2%) 1 (4%) 1 (4%)
Fibroadenoma 16 (32%) 9 (38%) 14 (45%) 6 (32%) 6 (24%) 6 (26%)
Fibroadenoma, Multiple 1 (2%)
Skin (50) (22) (23) (14) (26) (18)
Keratoacanthoma 1 (2%) 1 (4%)
Squamous Cell Carcinoma 1 (2%)
Squamous Cell Papilloma 1 (5%) 1 (7%) 2 (8%) 1 (6%)
Trichoepithelioma 1 (2%)
Subcutaneous Tissue, Fibroma 1 (4%)
Subcutaneous Tissue, Fibrosarcoma 1 (5%) 1 (4%)
Subcutaneous Tissue, Fibrous Histiocytoma 1 (5%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
None
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (21) (23) (13) (22) (17)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (22) (24) (13) (23) (18)
Alveolar/Bronchiolar Adenoma 1 (2%)
Alveolar/Bronchiolar Carcinoma 1 (2%) 1 (6%)
Carcinoma, Metastatic, Adrenal Gland 1 (6%)
Sarcoma, Metastatic 1 (6%)
Nose (50) (21) (23) (13) (22) (17)
Trachea (50) (21) (22) (12) (22) (17)
____________________________________________________________________________________________________________________________________
Page 4
NTP Experiment-Test: 05075-01 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: 09:05:50
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 PPM 0 PPM 240 PPM 800 PPM 800 PPM 800 PPM
0-0 10-0 1-1 0-3 3-3 10-3
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Ear (3) (1) (1) (1)
Pinna, Sarcoma 1 (100%) 1 (100%)
Eye (9) (6) (6) (7) (7) (9)
Lids, Fibrosarcoma 1 (11%)
Harderian Gland (3) (1) (3) (1) (1)
Zymbal's Gland (1) (1) (1)
Carcinoma 1 (100%) 1 (100%) 1 (100%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (21) (23) (13) (22) (17)
Urinary Bladder (50) (21) (20) (11) (20) (16)
____________________________________________________________________________________________________________________________________
SYSTEMIC LESIONS
Multiple Organs *(50) *(50) *(50) *(50) *(50) *(50)
Leukemia Mononuclear 13 (26%) 16 (32%) 21 (42%) 10 (20%) 10 (20%) 14 (28%)
____________________________________________________________________________________________________________________________________
* Number of animals with any tissue examined microscopically
Page 5
NTP Experiment-Test: 05075-01 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: 09:05:50
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 PPM 0 PPM 240 PPM 800 PPM 800 PPM 800 PPM
0-0 10-0 1-1 0-3 3-3 10-3
____________________________________________________________________________________________________________________________________
TUMOR SUMMARY
Total Animals with Primary Neoplasms (b) 45 40 40 38 40 38
Total Primary Neoplasms 102 75 69 59 66 55
Total Animals with Benign Neoplasms 41 33 27 34 33 27
Total Benign Neoplasms 76 51 46 43 50 34
Total Animals with Malignant Neoplasms 21 22 23 16 14 20
Total Malignant Neoplasms 26 24 23 16 16 21
Total Animals with Metastatic Neoplasms 1 1 3
Total Metastatic Neoplasm 1 1 3
Total Animals with Malignant Neoplasms
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: 05075-01 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: 09:05:50
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 2400 PPM 2400 PPM
0-10 10-10
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially in Study 50 50
Early Deaths
Moribund Sacrifice 11 13
Natural Death 1 1
Drowned 5
Survivors
Terminal Sacrifice 37 31
Moribund Sacrifice 1
Animals Examined Microscopically 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Esophagus (50) (50)
Intestine Large, Colon (50) (50)
Intestine Large, Rectum (50) (50)
Intestine Small, Ileum (48) (50)
Liver (50) (50)
Hepatocellular Adenoma 1 (2%)
Mesentery (1) (1)
Pancreas (50) (50)
Salivary Glands (49) (50)
Stomach, Forestomach (50) (50)
Stomach, Glandular (50) (50)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (50) (50)
Endocardium, Schwannoma Benign 1 (2%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Gland, Cortex (50) (50)
Adrenal Gland, Medulla (50) (50)
Pheochromocytoma Benign 2 (4%) 3 (6%)
Parathyroid Gland (48) (47)
Pituitary Gland (50) (50)
Pars Distalis, Adenoma 13 (26%) 13 (26%)
Thyroid Gland (50) (49)
Bilateral, C-Cell, Adenoma 1 (2%) 1 (2%)
C-Cell, Adenoma 4 (8%) 4 (8%)
Follicular Cell, Adenocarcinoma 1 (2%)
Page 7
NTP Experiment-Test: 05075-01 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: 09:05:50
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 2400 PPM 2400 PPM
0-10 10-10
____________________________________________________________________________________________________________________________________
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Clitoral Gland (50) (49)
Adenoma 1 (2%)
Carcinoma 1 (2%) 1 (2%)
Ovary (50) (50)
Granulosa Cell Tumor Malignant 1 (2%)
Uterus (50) (50)
Polyp Stromal 12 (24%) 6 (12%)
Sarcoma Stromal 1 (2%)
Endometrium, Adenocarcinoma 1 (2%)
Endometrium, Adenoma 1 (2%)
Endometrium, Sarcoma Stromal 1 (2%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (50) (50)
Lymph Node (49) (50)
Lymph Node, Mesenteric (4) (3)
Spleen (50) (50)
Thymus (45) (48)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (50) (49)
Fibroadenoma 4 (8%) 2 (4%)
Skin (50) (50)
Squamous Cell Papilloma 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Skeletal Muscle (1) (1)
____________________________________________________________________________________________________________________________________
Page 8
NTP Experiment-Test: 05075-01 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: 09:05:50
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 2400 PPM 2400 PPM
0-10 10-10
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (50)
Peripheral Nerve (1)
Spinal, Schwannoma Malignant 1 (100%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (50)
Alveolar/Bronchiolar Adenoma 1 (2%)
Carcinoma, Metastatic, Zymbal's Gland 1 (2%)
Nose (49) (50)
Trachea (50) (50)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Harderian Gland (7) (2)
Zymbal's Gland (1)
Carcinoma 1 (100%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (50)
Urinary Bladder (50) (50)
____________________________________________________________________________________________________________________________________
SYSTEMIC LESIONS
Multiple Organs *(50) *(50)
Leukemia Mononuclear 13 (26%) 8 (16%)
____________________________________________________________________________________________________________________________________
* Number of animals with any tissue examined microscopically
Page 9
NTP Experiment-Test: 05075-01 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: 09:05:50
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 2400 PPM 2400 PPM
0-10 10-10
____________________________________________________________________________________________________________________________________
TUMOR SUMMARY
Total Animals with Primary Neoplasms (b) 39 26
Total Primary Neoplasms 58 43
Total Animals with Benign Neoplasms 31 21
Total Benign Neoplasms 42 29
Total Animals with Malignant Neoplasms 16 14
Total Malignant Neoplasms 16 14
Total Animals with Metastatic Neoplasms 1
Total Metastatic Neoplasm 1
Total Animals with Malignant Neoplasms
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 10
NTP Experiment-Test: 05075-01 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: 09:05:50
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 PPM 0 PPM 240 PPM 800 PPM 800 PPM 800 PPM
0-0 10-0 1-1 0-3 3-3 10-3
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially in Study 50 50 50 50 50 50
Early Deaths
Moribund Sacrifice 22 21 13 21 24 21
Natural Death 2 5 4 3 4 6
Survivors
Terminal Sacrifice 25 23 33 26 21 21
Moribund Sacrifice 1 1 1
Natural Death 2
Animals Examined Microscopically 50 50 50 50 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Intestine Large, Cecum (49) (22) (13) (22) (26) (21)
Intestine Large, Colon (49) (24) (14) (22) (26) (23)
Intestine Large, Rectum (48) (24) (14) (22) (26) (22)
Intestine Small, Duodenum (48) (25) (15) (23) (26) (25)
Intestine Small, Ileum (46) (22) (13) (23) (26) (23)
Intestine Small, Jejunum (48) (24) (13) (22) (26) (22)
Liver (50) (50) (49) (50) (49) (49)
Hepatocellular Carcinoma 1 (2%) 1 (2%)
Hepatocellular Adenoma 1 (2%) 1 (2%) 1 (2%) 1 (2%) 1 (2%)
Hepatocellular Adenoma, Multiple 1 (2%) 1 (2%)
Histiocytic Sarcoma 1 (2%) 1 (2%) 1 (2%)
Mesentery (7) (3) (3) (3) (7) (2)
Pancreas (50) (27) (16) (23) (28) (25)
Salivary Glands (48) (27) (16) (23) (27) (28)
Stomach, Forestomach (49) (26) (15) (24) (27) (26)
Squamous Cell Carcinoma 1 (2%)
Squamous Cell Papilloma 1 (4%)
Stomach, Glandular (49) (25) (15) (23) (26) (23)
Tongue (1) (2)
Squamous Cell Papilloma 1 (100%) 1 (50%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (50) (28) (18) (25) (29) (29)
Schwannoma Benign 1 (2%)
____________________________________________________________________________________________________________________________________
Page 11
NTP Experiment-Test: 05075-01 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: 09:05:50
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 PPM 0 PPM 240 PPM 800 PPM 800 PPM 800 PPM
0-0 10-0 1-1 0-3 3-3 10-3
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Gland (50) (50) (50) (50) (48) (49)
Adrenal Gland, Cortex (50) (50) (48) (49) (47) (49)
Adrenal Gland, Medulla (50) (50) (50) (49) (48) (49)
Pheochromocytoma Malignant 1 (2%) 2 (4%) 1 (2%) 2 (4%) 4 (8%)
Pheochromocytoma Benign 13 (26%) 11 (22%) 11 (22%) 19 (39%) 4 (8%) 16 (33%)
Bilateral, Pheochromocytoma Benign 6 (12%) 1 (2%) 5 (10%) 7 (14%) 7 (15%) 3 (6%)
Islets, Pancreatic (50) (27) (15) (23) (28) (25)
Adenoma 3 (6%) 1 (4%) 1 (4%)
Carcinoma 1 (2%) 1 (4%) 1 (4%)
Pituitary Gland (50) (34) (20) (31) (30) (27)
Pars Distalis, Adenoma 14 (28%) 10 (29%) 6 (30%) 8 (26%) 10 (33%) 5 (19%)
Pars Intermedia, Adenoma 1 (3%)
Pars Nervosa, Histiocytic Sarcoma 1 (2%)
Thyroid Gland (49) (26) (14) (22) (27) (23)
Bilateral, C-Cell, Adenoma 3 (6%) 1 (7%) 1 (5%) 1 (4%)
C-Cell, Adenoma 8 (16%) 11 (42%) 6 (43%) 5 (23%) 5 (19%) 5 (22%)
C-Cell, Carcinoma 1 (2%) 1 (4%) 2 (7%) 1 (4%)
Follicular Cell, Adenocarcinoma 1 (2%) 2 (8%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
Tissue NOS (1) (2) (1) (1)
Chemodectoma Benign 1 (50%)
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Epididymis (48) (27) (17) (24) (27) (30)
Preputial Gland (49) (27) (18) (24) (33) (29)
Adenoma 2 (4%) 1 (4%) 1 (6%) 2 (8%) 1 (3%)
Carcinoma 2 (4%) 1 (4%) 1 (3%) 1 (3%)
Prostate (49) (27) (17) (24) (28) (29)
Testes (50) (50) (50) (48) (50) (49)
Adenoma 1 (2%)
Bilateral, Interstitial Cell, Adenoma 42 (84%) 45 (90%) 42 (84%) 43 (90%) 42 (84%) 41 (84%)
Interstitial Cell, Adenoma 4 (8%) 5 (10%) 5 (10%) 5 (10%) 8 (16%) 5 (10%)
Interstitial Cell, Carcinoma 1 (2%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (50) (26) (16) (23) (28) (29)
Femoral, Histiocytic Sarcoma 1 (2%) 1 (6%) 1 (4%)
Lymph Node (50) (27) (19) (26) (29) (29)
Mandibular, Histiocytic Sarcoma 1 (2%) 1 (5%) 1 (3%)
Page 12
NTP Experiment-Test: 05075-01 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: 09:05:50
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 PPM 0 PPM 240 PPM 800 PPM 800 PPM 800 PPM
0-0 10-0 1-1 0-3 3-3 10-3
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - cont
Mediastinal, Histiocytic Sarcoma 1 (5%) 1 (3%)
Lymph Node, Mesenteric (5) (7) (4) (5) (8) (4)
Spleen (49) (33) (29) (31) (35) (29)
Hemangiosarcoma 1 (3%)
Histiocytic Sarcoma 1 (3%) 1 (3%)
Sarcoma 1 (3%)
Thymus (40) (23) (15) (23) (28) (25)
Thymoma Benign 1 (4%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (23) (12) (8) (7) (14) (7)
Adenocarcinoma 1 (4%)
Fibroadenoma 3 (13%) 1 (8%) 4 (50%) 1 (7%) 1 (14%)
Sarcoma 1 (14%)
Skin (49) (29) (20) (31) (29) (30)
Basal Cell Adenoma 2 (6%)
Keratoacanthoma 1 (2%) 1 (3%) 3 (10%) 1 (3%) 1 (3%)
Squamous Cell Carcinoma 2 (4%) 1 (3%)
Squamous Cell Papilloma 1 (3%) 2 (6%)
Subcutaneous Tissue, Fibroma 1 (2%) 1 (3%) 4 (20%) 2 (6%) 1 (3%)
Subcutaneous Tissue, Fibrosarcoma 1 (2%) 2 (6%)
Subcutaneous Tissue, Hemangiosarcoma 1 (3%) 1 (3%)
Subcutaneous Tissue, Osteosarcoma 1 (3%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (49) (27) (18) (25) (29) (27)
Osteosarcoma 1 (3%)
Vertebra, Osteosarcoma 1 (3%)
Skeletal Muscle (1) (1) (1)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (27) (17) (24) (29) (29)
Astrocytoma Benign 1 (2%)
Astrocytoma Malignant 1 (4%)
Histiocytic Sarcoma 1 (2%)
Peripheral Nerve (1) (1)
Schwannoma Malignant 1 (100%) 1 (100%)
____________________________________________________________________________________________________________________________________
Page 13
NTP Experiment-Test: 05075-01 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: 09:05:50
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 PPM 0 PPM 240 PPM 800 PPM 800 PPM 800 PPM
0-0 10-0 1-1 0-3 3-3 10-3
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (27) (18) (24) (30) (29)
Alveolar/Bronchiolar Adenoma 1 (2%) 1 (4%) 1 (3%)
Alveolar/Bronchiolar Carcinoma 1 (6%)
Carcinoma 1 (2%)
Carcinoma, Metastatic 1 (6%)
Histiocytic Sarcoma 1 (2%) 1 (6%) 1 (3%)
Osteosarcoma, Metastatic 1 (3%)
Pheochromocytoma Malignant, Metastatic,
Adrenal Gland 1 (3%)
Nose (50) (27) (17) (24) (29) (29)
Polyp 1 (2%)
Nasolacrimal Duct, Histiocytic Sarcoma 1 (2%)
Trachea (50) (27) (17) (25) (29) (28)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Ear (1) (1) (2) (3)
Pinna, Basosquamous Tumor Benign 1 (33%)
Pinna, Fibrosarcoma 1 (33%)
Eye (9) (3) (6) (4) (3) (6)
Squamous Cell Carcinoma 1 (17%)
Harderian Gland (2) (1) (1) (1) (1)
Zymbal's Gland (1) (1) (1) (2)
Adenoma 1 (100%)
Carcinoma 1 (100%) 2 (100%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (28) (21) (28) (31) (30)
Sarcoma 1 (2%)
Transitional Epithelium, Carcinoma 1 (3%) 1 (3%)
Urinary Bladder (48) (26) (15) (23) (27) (24)
____________________________________________________________________________________________________________________________________
SYSTEMIC LESIONS
Multiple Organs *(50) *(50) *(50) *(50) *(50) *(50)
Histiocytic Sarcoma 1 (2%) 1 (2%) 1 (2%)
Leukemia Mononuclear 25 (50%) 25 (50%) 22 (44%) 24 (48%) 22 (44%) 9 (18%)
Mesothelioma Malignant 2 (4%) 1 (2%) 1 (2%) 3 (6%) 1 (2%) 3 (6%)
____________________________________________________________________________________________________________________________________
* Number of animals with any tissue examined microscopically
Page 14
NTP Experiment-Test: 05075-01 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: 09:05:50
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 PPM 0 PPM 240 PPM 800 PPM 800 PPM 800 PPM
0-0 10-0 1-1 0-3 3-3 10-3
____________________________________________________________________________________________________________________________________
TUMOR SUMMARY
Total Animals with Primary Neoplasms (b) 50 50 49 50 50 49
Total Primary Neoplasms 145 126 117 135 119 111
Total Animals with Benign Neoplasms 50 50 48 50 50 47
Total Benign Neoplasms 105 92 88 102 85 82
Total Animals with Malignant Neoplasms 36 30 28 28 30 24
Total Malignant Neoplasms 40 34 29 33 34 29
Total Animals with Metastatic Neoplasms 1 2 1
Total Metastatic Neoplasm 1 2 1
Total Animals with Malignant Neoplasms
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: 05075-01 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: 09:05:50
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 2400 PPM 2400 PPM
0-10 10-10
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially in Study 50 50
Early Deaths
Moribund Sacrifice 25 17
Natural Death 3 2
Survivors
Moribund Sacrifice 1 1
Terminal Sacrifice 21 30
Animals Examined Microscopically 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Esophagus (49) (50)
Intestine Large, Cecum (47) (48)
Intestine Large, Colon (46) (48)
Intestine Large, Rectum (47) (49)
Intestine Small, Duodenum (48) (48)
Intestine Small, Ileum (47) (48)
Intestine Small, Jejunum (48) (48)
Liver (50) (49)
Hepatocellular Adenoma 3 (6%) 1 (2%)
Hepatocellular Adenoma, Multiple 1 (2%) 4 (8%)
Histiocytic Sarcoma 1 (2%)
Mesentery (6) (4)
Pancreas (48) (50)
Salivary Glands (49) (50)
Stomach, Forestomach (49) (48)
Leiomyosarcoma 1 (2%)
Stomach, Glandular (49) (48)
Tooth (1)
Molar, Adamantinoma Benign 1 (100%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (50) (50)
Carcinoma, Metastatic 1 (2%)
Ventricle Left, Schwannoma Benign 1 (2%)
____________________________________________________________________________________________________________________________________
Page 16
NTP Experiment-Test: 05075-01 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: 09:05:50
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 2400 PPM 2400 PPM
0-10 10-10
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Gland (49) (50)
Adrenal Gland, Cortex (49) (50)
Adenoma 1 (2%) 2 (4%)
Histiocytic Sarcoma 1 (2%)
Adrenal Gland, Medulla (48) (50)
Pheochromocytoma Malignant 3 (6%)
Pheochromocytoma Benign 16 (33%) 16 (32%)
Bilateral, Pheochromocytoma Benign 9 (19%) 11 (22%)
Parathyroid Gland (49) (44)
Adenoma 1 (2%)
Pituitary Gland (48) (49)
Pars Distalis, Adenoma 10 (21%) 9 (18%)
Thyroid Gland (48) (49)
Bilateral, C-Cell, Adenoma 4 (8%)
C-Cell, Adenoma 10 (21%) 10 (20%)
C-Cell, Carcinoma 1 (2%) 4 (8%)
Follicular Cell, Adenocarcinoma 1 (2%)
Follicular Cell, Adenoma 1 (2%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
Tissue NOS (1)
Carcinoma 1 (100%)
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Epididymis (49) (48)
Preputial Gland (49) (50)
Adenoma 2 (4%)
Prostate (50) (49)
Testes (49) (49)
Bilateral, Interstitial Cell, Adenoma 40 (82%) 35 (71%)
Interstitial Cell, Adenoma 6 (12%) 10 (20%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (49) (50)
Femoral, Histiocytic Sarcoma 1 (2%)
Sternal, Histiocytic Sarcoma 1 (2%)
Vertebral, Histiocytic Sarcoma 1 (2%)
Lymph Node (50) (50)
Deep Cervical, Mediastinal, Mandibular,
Carcinoma, Metastatic, Thyroid Gland 1 (2%) 1 (2%)
Page 17
NTP Experiment-Test: 05075-01 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: 09:05:50
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 2400 PPM 2400 PPM
0-10 10-10
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - cont
Mandibular, Carcinoma, Metastatic, Skin 1 (2%)
Mediastinal, Histiocytic Sarcoma 1 (2%)
Lymph Node, Mesenteric (8) (8)
Spleen (50) (50)
Histiocytic Sarcoma 1 (2%)
Sarcoma 1 (2%)
Thymus (35) (39)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (19) (18)
Abdominal, Fibroadenoma 1 (6%)
Skin (49) (50)
Basal Cell Adenoma 1 (2%)
Fibroma 1 (2%)
Keratoacanthoma 1 (2%) 1 (2%)
Schwannoma Malignant 1 (2%)
Squamous Cell Carcinoma 2 (4%) 1 (2%)
Subcutaneous Tissue, Hemangiosarcoma 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (50) (50)
Left, Femur, Osteosarcoma 1 (2%)
Skeletal Muscle (1)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (50)
Oligodendroglioma Malignant 1 (2%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (50)
Alveolar/Bronchiolar Adenoma 1 (2%) 1 (2%)
Alveolar/Bronchiolar Carcinoma 1 (2%) 3 (6%)
Carcinoma, Metastatic, Thyroid Gland 1 (2%) 2 (4%)
Pheochromocytoma Malignant, Metastatic 1 (2%)
Nose (50) (50)
Trachea (50) (50)
Lamina Propria, Carcinoma, Metastatic,
Thyroid Gland 1 (2%)
____________________________________________________________________________________________________________________________________
Page 18
NTP Experiment-Test: 05075-01 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: 09:05:50
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 2400 PPM 2400 PPM
0-10 10-10
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Ear (3)
Harderian Gland (4)
Zymbal's Gland (1)
Carcinoma 1 (100%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (50)
Renal Tubule, Adenoma 1 (2%)
Urinary Bladder (49) (49)
____________________________________________________________________________________________________________________________________
SYSTEMIC LESIONS
Multiple Organs *(50) *(50)
Histiocytic Sarcoma 1 (2%)
Leukemia Mononuclear 19 (38%) 20 (40%)
Mesothelioma Malignant 1 (2%) 2 (4%)
____________________________________________________________________________________________________________________________________
* Number of animals with any tissue examined microscopically
Page 19
NTP Experiment-Test: 05075-01 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: 09:05:50
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 2400 PPM 2400 PPM
0-10 10-10
____________________________________________________________________________________________________________________________________
TUMOR SUMMARY
Total Animals with Primary Neoplasms (b) 49 50
Total Primary Neoplasms 133 146
Total Animals with Benign Neoplasms 48 49
Total Benign Neoplasms 104 108
Total Animals with Malignant Neoplasms 26 30
Total Malignant Neoplasms 29 38
Total Animals with Metastatic Neoplasms 2 3
Total Metastatic Neoplasm 5 4
Total Animals with Malignant Neoplasms
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 20
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