TDMS Study 05002-05 Pathology Tables
INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)
GAMMA-BUTYROLACTONE
NTP Experiment-Test: 05002-05 Report: PEIRPT05
Study Type: CHRONIC Date: 09/02/94
Route: GAVAGE Time: 17:53:00
Facility: Southern Research Institute
Chemical CAS #: 96-48-0
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: 05002-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC GAMMA-BUTYROLACTONE Date: 09/02/94
Route: GAVAGE Time: 17:53:00
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE VEHICLE 225. 450.
CONTROL MG/KG MG/KG
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially in Study 50 50 50
Early Deaths
Moribund 19 16 14
Dead 3 7 6
Dosing Accident 2
Survivors
Terminal Sacrifice 28 26 28
Dead 1
Animals Examined Microscopically 50 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Intestine Large, Cecum (48) (18) (46)
Intestine Large, Colon (48) (20) (49)
Intestine Large, Rectum (48) (20) (43)
Mixed Tumor Malignant, Metastatic, Mammary
Gland 1 (5%)
Intestine Small, Ileum (47) (20) (45)
Intestine Small, Jejunum (47) (20) (47)
Liver (50) (50) (50)
Mixed Tumor Malignant, Metastatic, Mammary
Gland 1 (2%)
Mesentery (5) (3) (4)
Pancreas (49) (24) (50)
Acinar Cell, Adenoma 2 (4%)
Pharynx (2)
Palate, Squamous Cell Carcinoma 1 (50%)
Palate, Squamous Cell Papilloma 1 (50%)
Salivary Glands (50) (24) (50)
Carcinoma, Metastatic 1 (2%)
Stomach (49) (24) (50)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (50) (25) (50)
Fibrosarcoma, Metastatic, Lung 1 (2%)
____________________________________________________________________________________________________________________________________
Page 2
NTP Experiment-Test: 05002-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC GAMMA-BUTYROLACTONE Date: 09/02/94
Route: GAVAGE Time: 17:53:00
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE VEHICLE 225. 450.
CONTROL MG/KG MG/KG
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Gland, Cortex (50) (25) (50)
Adenoma 1 (2%) 2 (4%)
Adrenal Gland, Medulla (50) (25) (49)
Pheochromocytoma Malignant 1 (4%)
Pheochromocytoma Benign 1 (2%) 4 (8%)
Islets, Pancreatic (49) (24) (50)
Adenoma 1 (2%)
Carcinoma 1 (2%)
Parathyroid Gland (48) (23) (47)
Carcinoma, Metastatic, Thyroid Gland 1 (2%)
Pituitary Gland (49) (37) (48)
Pars Distalis, Adenoma 22 (45%) 24 (65%) 16 (33%)
Thyroid Gland (50) (27) (50)
C-Cell, Adenoma 7 (14%) 2 (7%) 3 (6%)
C-Cell, Carcinoma 1 (2%) 1 (4%) 1 (2%)
Follicular Cell, Carcinoma 1 (2%) 1 (4%) 2 (4%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Clitoral Gland (48) (22) (46)
Adenoma 5 (10%) 4 (18%) 5 (11%)
Carcinoma 1 (2%)
Bilateral, Adenoma 1 (2%) 1 (5%)
Ovary (50) (24) (50)
Uterus (50) (32) (50)
Adenocarcinoma 1 (3%)
Adenoma 1 (2%)
Hemangiosarcoma 1 (2%)
Polyp Stromal 10 (20%) 7 (22%) 12 (24%)
Polyp Stromal, Multiple 2 (6%) 1 (2%)
Sarcoma Stromal 1 (2%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Blood (2) (4)
Bone Marrow (49) (24) (50)
Lymph Node (50) (26) (50)
Axillary, Mixed Tumor Malignant, Metastatic,
Mammary Gland 1 (4%)
Page 3
NTP Experiment-Test: 05002-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC GAMMA-BUTYROLACTONE Date: 09/02/94
Route: GAVAGE Time: 17:53:00
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE VEHICLE 225. 450.
CONTROL MG/KG MG/KG
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - cont
Lymph Node, Mandibular (49) (23) (50)
Carcinoma, Metastatic 1 (2%)
Lymph Node, Mesenteric (49) (24) (49)
Spleen (48) (49) (50)
Sarcoma 1 (2%)
Thymus (48) (21) (47)
Fibrosarcoma, Metastatic, Lung 1 (2%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (50) (50) (50)
Adenocarcinoma 4 (8%)
Adenoma 1 (2%)
Fibroadenoma 16 (32%) 10 (20%) 5 (10%)
Fibroadenoma, Multiple 6 (12%) 4 (8%) 1 (2%)
Mixed Tumor Malignant 1 (2%)
Skin (50) (28) (50)
Lip, Squamous Cell Papilloma 1 (2%)
Subcutaneous Tissue, Carcinoma, Metastatic 1 (2%)
Subcutaneous Tissue, Fibroma 1 (4%)
Subcutaneous Tissue, Fibroma, Multiple 1 (2%)
Subcutaneous Tissue, Fibrosarcoma 1 (4%) 1 (2%)
Subcutaneous Tissue, Hemangiosarcoma 1 (2%)
Subcutaneous Tissue, Myxosarcoma 1 (2%)
Subcutaneous Tissue, Sarcoma 1 (4%) 1 (2%)
Subcutaneous Tissue, Squamous Cell Carcinoma,
Multiple 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (50) (28) (50)
Vertebra, Osteosarcoma 1 (4%)
Skeletal Muscle (2) (1)
Hindlimb, Hemangiosarcoma, Extension 1 (100%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (24) (50)
Astrocytoma Malignant 1 (2%)
Meninges, Carcinoma, Metastatic, Zymbal's
Gland 1 (4%)
____________________________________________________________________________________________________________________________________
Page 4
NTP Experiment-Test: 05002-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC GAMMA-BUTYROLACTONE Date: 09/02/94
Route: GAVAGE Time: 17:53:00
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE VEHICLE 225. 450.
CONTROL MG/KG MG/KG
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (30) (50)
Alveolar/Bronchiolar Adenoma 1 (3%) 2 (4%)
Alveolar/Bronchiolar Carcinoma 1 (2%)
Carcinoma, Metastatic 1 (2%)
Mixed Tumor Malignant, Metastatic, Mammary
Gland 1 (3%)
Mediastinum, Fibrosarcoma 1 (2%)
Mediastinum, Mixed Tumor Malignant,
Metastatic, Mammary Gland 1 (3%)
Mediastinum, Squamous Cell Carcinoma 1 (2%)
Trachea (50) (24) (50)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Zymbal's Gland (2) (1)
Carcinoma 2 (100%) 1 (100%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (49) (24) (49)
Urinary Bladder (50) (24) (50)
Transitional Epithelium, Papilloma, Multiple 1 (2%)
____________________________________________________________________________________________________________________________________
SYSTEMIC LESIONS
Multiple Organs *(50) *(50) *(50)
Leukemia Mononuclear 13 (26%) 9 (18%) 11 (22%)
____________________________________________________________________________________________________________________________________
* Number of animals with any tissue examined microscopically
Page 5
NTP Experiment-Test: 05002-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC GAMMA-BUTYROLACTONE Date: 09/02/94
Route: GAVAGE Time: 17:53:00
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE VEHICLE 225. 450.
CONTROL MG/KG MG/KG
____________________________________________________________________________________________________________________________________
TUMOR SUMMARY
Total Animals with Primary Neoplasms (b) 46 46 41
Total Primary Neoplasms 99 78 77
Total Animals with Benign Neoplasms 38 42 33
Total Benign Neoplasms 75 57 53
Total Animals with Malignant Neoplasms 22 19 19
Total Malignant Neoplasms 24 21 24
Total Animals with Metastatic Neoplasms 2 2 1
Total Metastatic Neoplasm 3 6 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 6
NTP Experiment-Test: 05002-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC GAMMA-BUTYROLACTONE Date: 09/02/94
Route: GAVAGE Time: 17:53:00
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE VEHICLE 112. 225.
CONTROL MG/KG MG/KG
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially in Study 50 50 50
Early Deaths
Dead 6 7 3
Moribund 19 13 12
Dosing Accident 1 3 3
Survivors
Terminal Sacrifice 24 27 32
Animals Examined Microscopically 50 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Intestine Large, Cecum (48) (17) (49)
Intestine Large, Colon (47) (21) (50)
Polyp Adenomatous 1 (5%)
Intestine Large, Rectum (47) (19) (49)
Intestine Small, Ileum (46) (18) (49)
Intestine Small, Jejunum (46) (17) (50)
Adenocarcinoma 1 (2%)
Liver (50) (50) (50)
Fibrous Histiocytoma, Metastatic, Uncertain
Primary Site 1 (2%)
Hepatocellular Carcinoma 1 (2%)
Osteosarcoma, Metastatic, Uncertain Primary
Site 1 (2%)
Mesentery (11) (10) (19)
Fibrous Histiocytoma, Metastatic, Uncertain
Primary Site 1 (5%)
Osteosarcoma, Metastatic, Uncertain Primary
Site 1 (9%)
Pancreas (50) (22) (50)
Fibrous Histiocytoma, Metastatic, Uncertain
Primary Site 1 (2%)
Osteosarcoma, Metastatic, Uncertain Primary
Site 1 (2%)
Acinar Cell, Adenoma 4 (8%) 4 (8%)
Acinar Cell, Adenoma, Multiple 3 (6%) 1 (2%)
Salivary Glands (49) (23) (50)
Schwannoma Malignant 1 (4%)
Stomach (50) (29) (50)
Forestomach, Squamous Cell Papilloma 1 (2%) 1 (2%)
Tongue (3) (4)
Squamous Cell Papilloma 1 (25%)
____________________________________________________________________________________________________________________________________
Page 7
NTP Experiment-Test: 05002-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC GAMMA-BUTYROLACTONE Date: 09/02/94
Route: GAVAGE Time: 17:53:00
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE VEHICLE 112. 225.
CONTROL MG/KG MG/KG
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (50) (25) (50)
Fibrous Histiocytoma, Metastatic, Uncertain
Primary Site 1 (2%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Gland, Cortex (48) (24) (49)
Adenoma 1 (2%) 1 (2%)
Fibrous Histiocytoma, Metastatic, Uncertain
Primary Site 1 (2%)
Adrenal Gland, Medulla (48) (23) (49)
Pheochromocytoma Malignant 1 (4%) 5 (10%)
Pheochromocytoma Benign 10 (21%) 6 (26%) 7 (14%)
Bilateral, Pheochromocytoma Benign 5 (10%) 4 (17%) 7 (14%)
Islets, Pancreatic (49) (22) (50)
Adenoma 3 (6%) 2 (4%)
Adenoma, Multiple 1 (2%)
Carcinoma 2 (4%) 1 (5%)
Parathyroid Gland (46) (22) (48)
Adenoma 1 (2%)
Pituitary Gland (48) (28) (49)
Pars Distalis, Adenoma 11 (23%) 11 (39%) 16 (33%)
Pars Distalis, Carcinoma 1 (2%) 1 (4%)
Thyroid Gland (50) (25) (50)
Bilateral, C-Cell, Adenoma 1 (2%)
C-Cell, Adenoma 6 (12%) 1 (4%) 5 (10%)
C-Cell, Carcinoma 4 (8%) 1 (4%) 2 (4%)
Follicular Cell, Adenoma 1 (2%)
Follicular Cell, Carcinoma 1 (2%) 1 (4%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Epididymis (50) (23) (50)
Preputial Gland (48) (24) (50)
Adenoma 6 (13%) 1 (4%) 2 (4%)
Carcinoma 1 (2%) 3 (13%) 3 (6%)
Bilateral, Carcinoma 1 (4%)
Prostate (49) (24) (49)
Page 8
NTP Experiment-Test: 05002-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC GAMMA-BUTYROLACTONE Date: 09/02/94
Route: GAVAGE Time: 17:53:00
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE VEHICLE 112. 225.
CONTROL MG/KG MG/KG
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM - cont
Seminal Vesicle (50) (25) (50)
Fibrous Histiocytoma, Metastatic, Uncertain
Primary Site 1 (2%)
Testes (50) (50) (50)
Bilateral, Interstitial Cell, Adenoma 37 (74%) 36 (72%) 35 (70%)
Interstitial Cell, Adenoma 7 (14%) 10 (20%) 9 (18%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Blood (2) (2)
Bone Marrow (50) (23) (50)
Fibrous Histiocytoma, Metastatic, Uncertain
Primary Site 1 (2%)
Lymph Node (50) (25) (50)
Inguinal, Fibrous Histiocytoma, Metastatic,
Uncertain Primary Site 1 (2%)
Mediastinal, Fibrous Histiocytoma,
Metastatic, Uncertain Primary Site 1 (2%)
Lymph Node, Mandibular (48) (21) (49)
Lymph Node, Mesenteric (48) (23) (50)
Spleen (50) (45) (50)
Fibrosarcoma 1 (2%)
Fibrous Histiocytoma, Metastatic, Uncertain
Primary Site 1 (2%)
Hemangiosarcoma 1 (2%)
Osteosarcoma, Metastatic, Uncertain Primary
Site 1 (2%)
Thymus (43) (20) (49)
Fibrous Histiocytoma, Metastatic, Uncertain
Primary Site 1 (2%)
Thymoma Benign 1 (2%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (44) (23) (48)
Adenocarcinoma 1 (4%)
Fibroadenoma 4 (9%) 1 (4%) 3 (6%)
Skin (50) (37) (50)
Basal Cell Adenoma 4 (11%)
Basal Cell Carcinoma 1 (2%)
Keratoacanthoma 1 (2%) 4 (11%) 5 (10%)
Keratoacanthoma, Multiple 1 (2%)
Subcutaneous Tissue, Fibroma 3 (6%) 4 (11%) 4 (8%)
Subcutaneous Tissue, Fibroma, Multiple 2 (5%)
Subcutaneous Tissue, Fibrosarcoma 4 (8%)
Page 9
NTP Experiment-Test: 05002-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC GAMMA-BUTYROLACTONE Date: 09/02/94
Route: GAVAGE Time: 17:53:00
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE VEHICLE 112. 225.
CONTROL MG/KG MG/KG
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM - cont
Subcutaneous Tissue, Lipoma 2 (4%)
Subcutaneous Tissue, Myxosarcoma 1 (3%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (50) (23) (50)
Cranium, Carcinoma, Metastatic, Zymbal's
Gland 1 (2%)
Skeletal Muscle (1) (1) (3)
Fibroma 1 (100%)
Abdominal, Osteosarcoma, Metastatic,
Uncertain Primary Site 1 (100%)
Back, Fibrous Histiocytoma, Metastatic,
Uncertain Primary Site 1 (33%)
Diaphragm, Osteosarcoma, Metastatic,
Uncertain Primary Site 1 (100%)
Neck, Carcinoma, Extension, Metastatic,
Thyroid Gland 1 (33%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (24) (50)
Astrocytoma Malignant 1 (4%)
Meningioma Malignant 1 (2%)
Meninges, Carcinoma, Metastatic, Zymbal's
Gland 1 (2%)
Nerve, Carcinoma, Metastatic, Zymbal's Gland 1 (2%)
Spinal Cord (2) (1)
Fibrous Histiocytoma, Metastatic, Uncertain
Primary Site 1 (100%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (29) (50)
Alveolar/Bronchiolar Adenoma 2 (4%) 1 (3%) 3 (6%)
Alveolar/Bronchiolar Carcinoma 1 (2%)
Carcinoma, Multiple, Metastatic, Thyroid
Gland 1 (2%)
Fibrous Histiocytoma, Metastatic, Uncertain
Primary Site 1 (2%)
Osteosarcoma, Metastatic 1 (3%)
Artery, Pheochromocytoma Malignant,
Metastatic, Adrenal Gland 1 (2%)
Mediastinum, Osteosarcoma, Metastatic,
Page 10
NTP Experiment-Test: 05002-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC GAMMA-BUTYROLACTONE Date: 09/02/94
Route: GAVAGE Time: 17:53:00
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE VEHICLE 112. 225.
CONTROL MG/KG MG/KG
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM - cont
Uncertain Primary Site 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Ear (2) (2)
Schwannoma Malignant 1 (50%)
Zymbal's Gland (1) (1)
Carcinoma 1 (100%) 1 (100%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (23) (50)
Fibrous Histiocytoma, Metastatic, Uncertain
Primary Site 1 (2%)
Lipoma 1 (4%)
Transitional Epithelium, Carcinoma 1 (2%) 1 (4%)
Urinary Bladder (48) (22) (50)
____________________________________________________________________________________________________________________________________
SYSTEMIC LESIONS
Multiple Organs *(50) *(50) *(50)
Leukemia Mononuclear 16 (32%) 15 (30%) 9 (18%)
Mesothelioma Malignant 1 (2%) 4 (8%)
____________________________________________________________________________________________________________________________________
* Number of animals with any tissue examined microscopically
Page 11
NTP Experiment-Test: 05002-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC GAMMA-BUTYROLACTONE Date: 09/02/94
Route: GAVAGE Time: 17:53:00
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE VEHICLE 112. 225.
CONTROL MG/KG MG/KG
____________________________________________________________________________________________________________________________________
TUMOR SUMMARY
Total Animals with Primary Neoplasms (b) 50 49 50
Total Primary Neoplasms 141 120 138
Total Animals with Benign Neoplasms 46 48 50
Total Benign Neoplasms 106 89 111
Total Animals with Malignant Neoplasms 29 29 22
Total Malignant Neoplasms 35 31 27
Total Animals with Metastatic Neoplasms 2 1 3
Total Metastatic Neoplasm 10 1 18
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
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