TDMS Study 88035-05 Pathology Tables
NTP Experiment-Test: 88035-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC PRIMACLONE Date: 10/01/96
Route: DOSED FEED Time: 10:21:25
CORE STUDY
Facility: Battelle Columbus Laboratory
Chemical CAS #: 0000125-33-7
Lock Date: 11/17/94
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: 88035-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC PRIMACLONE Date: 10/01/96
Route: DOSED FEED Time: 10:21:25
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0.0% 0.06% 0.13% 0.25%
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially in Study 50 50 50 50
Early Deaths
Moribund Sacrifice 21 18 14 19
Natural Death 5 5 5 3
Survivors
Terminal Sacrifice 24 27 31 27
Natural Death 1
Animals Examined Microscopically 50 50 50 50
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ALIMENTARY SYSTEM
Intestine Large, Colon (50) (50) (50) (50)
Intestine Large, Cecum (49) (50) (50) (49)
Fibrosarcoma, Metastatic, Spleen 1 (2%)
Intestine Small, Duodenum (49) (50) (50) (50)
Intestine Small, Jejunum (49) (50) (50) (49)
Fibrosarcoma, Metastatic, Spleen 1 (2%)
Intestine Small, Ileum (50) (50) (50) (49)
Fibrosarcoma, Metastatic, Spleen 1 (2%)
Liver (50) (50) (50) (50)
Fibrosarcoma, Metastatic, Spleen 1 (2%)
Hepatocellular Adenoma 1 (2%) 1 (2%)
Mesentery (9) (10) (7) (7)
Fibrosarcoma, Metastatic, Spleen 1 (14%)
Oral Mucosa (2)
Gingival, Squamous Cell Carcinoma 1 (50%)
Pharyngeal, Squamous Cell Carcinoma 1 (50%)
Pancreas (49) (50) (50) (50)
Fibrosarcoma, Metastatic, Spleen 1 (2%)
Salivary Glands (49) (50) (50) (50)
Stomach, Forestomach (49) (50) (50) (50)
Stomach, Glandular (49) (50) (50) (50)
Carcinoid Tumor Benign 1 (2%)
Carcinoid Tumor Malignant 1 (2%)
Fibrosarcoma, Metastatic, Spleen 1 (2%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Blood Vessel (49) (50) (50) (50)
Heart (49) (50) (50) (50)
Schwannoma Malignant 1 (2%)
____________________________________________________________________________________________________________________________________
Page 2
NTP Experiment-Test: 88035-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC PRIMACLONE Date: 10/01/96
Route: DOSED FEED Time: 10:21:25
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0.0% 0.06% 0.13% 0.25%
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (50) (50) (50) (50)
Adenoma 1 (2%) 2 (4%) 1 (2%)
Thymoma Malignant, Metastatic, Thymus 1 (2%)
Adrenal Medulla (50) (50) (49) (50)
Pheochromocytoma Benign 2 (4%) 2 (4%) 3 (6%)
Islets, Pancreatic (50) (50) (50) (50)
Adenoma 1 (2%)
Parathyroid Gland (38) (44) (42) (39)
Pituitary Gland (49) (50) (49) (50)
Pars Distalis, Adenoma 16 (33%) 20 (40%) 13 (27%) 18 (36%)
Pars Distalis, Adenoma, Multiple 1 (2%) 1 (2%) 2 (4%)
Pars Distalis, Carcinoma 1 (2%)
Thyroid Gland (49) (50) (50) (50)
Bilateral, C-Cell, Adenoma 1 (2%)
C-Cell, Adenoma 5 (10%) 2 (4%) 6 (12%) 4 (8%)
Follicular Cell, Carcinoma 1 (2%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
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GENITAL SYSTEM
Clitoral Gland (49) (49) (50) (50)
Adenoma 4 (8%) 1 (2%) 4 (8%) 1 (2%)
Carcinoma 1 (2%) 1 (2%) 2 (4%)
Ovary (50) (50) (50) (49)
Granulosa-Theca Tumor Malignant 1 (2%)
Uterus (50) (50) (50) (49)
Leiomyosarcoma 1 (2%)
Polyp Stromal 7 (14%) 7 (14%) 6 (12%) 7 (14%)
Polyp Stromal, Multiple 1 (2%)
Sarcoma Stromal 3 (6%) 3 (6%)
Vagina (1) (1) (2)
Polyp 1 (100%) 2 (100%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (50) (50) (50) (50)
Lymph Node (11) (7) (8) (12)
Thoracic, Carcinoma, Metastatic, Mammary
Gland 1 (13%)
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NTP Experiment-Test: 88035-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC PRIMACLONE Date: 10/01/96
Route: DOSED FEED Time: 10:21:25
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0.0% 0.06% 0.13% 0.25%
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - cont
Lymph Node, Mandibular (49) (50) (50) (50)
Lymph Node, Mesenteric (50) (50) (50) (49)
Spleen (49) (50) (50) (50)
Fibrosarcoma 1 (2%)
Thymus (49) (45) (47) (46)
Thymoma Benign 1 (2%)
Thymoma Malignant 1 (2%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (50) (50) (50) (50)
Adenoma 2 (4%)
Carcinoma 1 (2%) 2 (4%) 1 (2%)
Fibroadenoma 13 (26%) 21 (42%) 14 (28%) 11 (22%)
Fibroadenoma, Multiple 9 (18%) 4 (8%) 2 (4%) 1 (2%)
Skin (50) (50) (50) (50)
Basal Cell Carcinoma 1 (2%)
Pinna, Squamous Cell Papilloma 1 (2%)
Subcutaneous Tissue, Fibroma 1 (2%) 1 (2%) 1 (2%)
Subcutaneous Tissue, Fibrosarcoma 1 (2%) 1 (2%) 1 (2%) 2 (4%)
Subcutaneous Tissue, Liposarcoma 1 (2%)
Subcutaneous Tissue, Sarcoma 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Skeletal Muscle (1) (2)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (50) (50) (50)
Astrocytoma Malignant 1 (2%) 1 (2%)
Carcinoma, Metastatic, Pituitary Gland 1 (2%)
Spinal Cord (1) (2)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (49) (50) (50) (50)
Alveolar/Bronchiolar Adenoma 1 (2%) 2 (4%)
Carcinoma, Metastatic, Mammary Gland 1 (2%)
Thymoma Malignant, Metastatic, Thymus 1 (2%)
Trachea (49) (50) (50) (50)
____________________________________________________________________________________________________________________________________
Page 4
NTP Experiment-Test: 88035-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC PRIMACLONE Date: 10/01/96
Route: DOSED FEED Time: 10:21:25
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0.0% 0.06% 0.13% 0.25%
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Zymbal's Gland (1) (1)
Carcinoma 1 (100%) 1 (100%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (50) (50) (50)
Urinary Bladder (50) (50) (50) (49)
____________________________________________________________________________________________________________________________________
SYSTEMIC LESIONS
Multiple Organs *(50) *(50) *(50) *(50)
Leukemia Mononuclear 13 (26%) 13 (26%) 13 (26%) 22 (44%)
____________________________________________________________________________________________________________________________________
* Number of animals with any tissue examined microscopically
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NTP Experiment-Test: 88035-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC PRIMACLONE Date: 10/01/96
Route: DOSED FEED Time: 10:21:25
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0.0% 0.06% 0.13% 0.25%
____________________________________________________________________________________________________________________________________
TUMOR SUMMARY
Total Animals with Primary Neoplasms (b) 47 44 41 46
Total Primary Neoplasms 86 81 72 88
Total Animals with Benign Neoplasms 39 35 35 33
Total Benign Neoplasms 63 60 53 54
Total Animals with Malignant Neoplasms 21 20 17 28
Total Malignant Neoplasms 23 21 19 34
Total Animals with Metastatic Neoplasms 1 1 2
Total Metastatic Neoplasm 2 2 8
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
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NTP Experiment-Test: 88035-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC PRIMACLONE Date: 10/01/96
Route: DOSED FEED Time: 10:21:25
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0.0% 0.06% 0.13% 0.25%
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially in Study 50 50 50 50
Early Deaths
Moribund Sacrifice 33 33 39 36
Natural Death 4 10 7 14
Survivors
Terminal Sacrifice 13 7 4
Animals Examined Microscopically 50 50 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Intestine Large, Colon (50) (50) (49) (46)
Polyp Adenomatous 1 (2%)
Intestine Small, Duodenum (50) (50) (50) (47)
Intestine Small, Jejunum (50) (50) (49) (45)
Carcinoma 1 (2%)
Leiomyosarcoma 1 (2%)
Intestine Small, Ileum (50) (50) (49) (46)
Leiomyosarcoma 1 (2%)
Liver (50) (50) (50) (50)
Fibrosarcoma, Metastatic, Spleen 1 (2%)
Hepatocellular Adenoma 1 (2%) 1 (2%)
Hepatocellular Adenoma, Multiple 1 (2%) 1 (2%)
Mesentery (11) (6) (9) (3)
Fat, Fibrosarcoma, Metastatic, Spleen 1 (9%)
Oral Mucosa (1)
Pharyngeal, Squamous Cell Carcinoma 1 (100%)
Pancreas (50) (50) (50) (49)
Salivary Glands (50) (50) (49) (49)
Stomach, Forestomach (50) (50) (50) (49)
Squamous Cell Papilloma 1 (2%)
Stomach, Glandular (50) (50) (50) (49)
Tongue (1)
Squamous Cell Papilloma 1 (100%)
Tooth (1)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (50) (50) (50) (50)
____________________________________________________________________________________________________________________________________
Page 7
NTP Experiment-Test: 88035-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC PRIMACLONE Date: 10/01/96
Route: DOSED FEED Time: 10:21:25
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0.0% 0.06% 0.13% 0.25%
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (50) (50) (50) (50)
Adrenal Medulla (50) (50) (50) (49)
Pheochromocytoma Malignant 1 (2%) 1 (2%) 1 (2%)
Pheochromocytoma Benign 16 (32%) 19 (38%) 19 (38%) 7 (14%)
Bilateral, Pheochromocytoma Benign 7 (14%) 9 (18%) 5 (10%) 5 (10%)
Islets, Pancreatic (50) (50) (50) (49)
Adenoma 1 (2%)
Carcinoma 1 (2%)
Parathyroid Gland (45) (41) (46) (49)
Pituitary Gland (49) (50) (48) (49)
Pars Distalis, Adenoma 17 (35%) 12 (24%) 11 (23%) 4 (8%)
Pars Intermedia, Adenoma 1 (2%) 1 (2%) 1 (2%)
Thyroid Gland (50) (50) (49) (49)
Bilateral, C-Cell, Adenoma 1 (2%)
C-Cell, Adenoma 7 (14%) 2 (4%) 7 (14%) 1 (2%)
C-Cell, Carcinoma 1 (2%) 1 (2%)
Follicular Cell, Adenoma 1 (2%) 1 (2%) 6 (12%) 3 (6%)
Follicular Cell, Carcinoma 1 (2%) 3 (6%) 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
Peritoneum (1) (1) (1)
Tissue NOS (1)
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Coagulating Gland (2) (1) (1)
Epididymis (50) (50) (50) (48)
Preputial Gland (50) (50) (50) (49)
Adenoma 2 (4%) 1 (2%) 2 (4%)
Carcinoma 1 (2%)
Prostate (50) (50) (50) (48)
Seminal Vesicle (50) (50) (50) (48)
Testes (50) (50) (50) (48)
Bilateral, Interstitial Cell, Adenoma 33 (66%) 33 (66%) 35 (70%) 34 (71%)
Interstitial Cell, Adenoma 8 (16%) 11 (22%) 7 (14%) 9 (19%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (50) (50) (50) (50)
Lymph Node (24) (23) (16) (10)
Lymph Node, Mandibular (50) (50) (48) (49)
Lymph Node, Mesenteric (50) (50) (50) (48)
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NTP Experiment-Test: 88035-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC PRIMACLONE Date: 10/01/96
Route: DOSED FEED Time: 10:21:25
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0.0% 0.06% 0.13% 0.25%
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - cont
Spleen (50) (50) (50) (49)
Fibrosarcoma 3 (6%) 1 (2%)
Thymus (49) (47) (44) (46)
Thymoma Malignant 1 (2%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (48) (49) (50) (47)
Adenoma 1 (2%)
Carcinoma 2 (4%)
Fibroadenoma 3 (6%) 3 (6%) 3 (6%)
Skin (50) (50) (50) (50)
Basal Cell Adenoma 1 (2%)
Basal Cell Carcinoma 1 (2%)
Basosquamous Tumor Benign 1 (2%)
Keratoacanthoma 1 (2%) 1 (2%)
Trichoepithelioma 1 (2%)
Pinna, Melanoma Malignant 1 (2%)
Pinna, Squamous Cell Papilloma 1 (2%) 1 (2%) 1 (2%)
Subcutaneous Tissue, Fibroma 3 (6%) 3 (6%) 3 (6%)
Subcutaneous Tissue, Fibrosarcoma 2 (4%)
Subcutaneous Tissue, Hemangiosarcoma 1 (2%)
Subcutaneous Tissue, Pinna, Melanoma Benign 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (50) (50) (50) (50)
Chordoma 1 (2%)
Mandible, Osteosarcoma 1 (2%)
Tibia, Osteosarcoma 1 (2%)
Skeletal Muscle (1)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (50) (49) (49)
Astrocytoma Malignant 2 (4%)
Peripheral Nerve (1) (1)
Spinal, Schwannoma Malignant 1 (100%)
____________________________________________________________________________________________________________________________________
Page 9
NTP Experiment-Test: 88035-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC PRIMACLONE Date: 10/01/96
Route: DOSED FEED Time: 10:21:25
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0.0% 0.06% 0.13% 0.25%
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (50) (50) (50)
Alveolar/Bronchiolar Adenoma 1 (2%) 1 (2%)
Alveolar/Bronchiolar Carcinoma 1 (2%) 1 (2%)
Chordoma, Metastatic, Bone 1 (2%)
Fibrosarcoma, Metastatic, Spleen 1 (2%)
Hemangiosarcoma, Metastatic, Skin 1 (2%)
Osteosarcoma, Metastatic, Bone 1 (2%)
Squamous Cell Carcinoma 1 (2%)
Nose (50) (50) (50) (50)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Zymbal's Gland (1)
Carcinoma 1 (100%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (50) (50) (50)
Fibrosarcoma, Metastatic, Spleen 1 (2%)
Lipoma 1 (2%)
Osteosarcoma, Metastatic, Bone 1 (2%)
Renal Tubule, Adenoma 2 (4%) 1 (2%) 1 (2%) 1 (2%)
Renal Tubule, Carcinoma 1 (2%)
Urinary Bladder (50) (50) (50) (48)
Papilloma 1 (2%)
____________________________________________________________________________________________________________________________________
SYSTEMIC LESIONS
Multiple Organs *(50) *(50) *(50) *(50)
Leukemia Mononuclear 35 (70%) 30 (60%) 24 (48%) 12 (24%)
Lymphoma Malignant 1 (2%)
Mesothelioma Malignant 2 (4%) 3 (6%) 2 (4%) 1 (2%)
____________________________________________________________________________________________________________________________________
* Number of animals with any tissue examined microscopically
Page 10
NTP Experiment-Test: 88035-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC PRIMACLONE Date: 10/01/96
Route: DOSED FEED Time: 10:21:25
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0.0% 0.06% 0.13% 0.25%
____________________________________________________________________________________________________________________________________
TUMOR SUMMARY
Total Animals with Primary Neoplasms (b) 50 49 50 47
Total Primary Neoplasms 160 144 143 87
Total Animals with Benign Neoplasms 49 49 49 44
Total Benign Neoplasms 105 103 107 69
Total Animals with Malignant Neoplasms 41 35 29 15
Total Malignant Neoplasms 55 41 36 18
Total Animals with Metastatic Neoplasms 3 1
Total Metastatic Neoplasm 7 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
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