NTP Experiment-Test: 88070-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC ISOBUTENE Date: 06/11/97
Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 10:30:48
CORE STUDY
Facility: Battelle Northwest
Chemical CAS #: 115-11-0007
Lock Date: 10/05/95
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: 88070-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC ISOBUTENE Date: 06/11/97
Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 10:30:48
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE CONTROL 500 PPM 2000 PPM 8000 PPM
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially in Study 50 50 50 50
Early Deaths
Moribund Sacrifice 21 25 15 23
Natural Death 6 5 2 5
Accidently Killed 1
Survivors
Terminal Sacrifice 23 19 33 22
Animals Examined Microscopically 50 50 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Intestine Large, Colon (49) (50) (49) (49)
Intestine Large, Rectum (47) (47) (47) (48)
Polyp Adenomatous 1 (2%)
Intestine Large, Cecum (48) (49) (48) (49)
Intestine Small, Duodenum (49) (50) (48) (48)
Intestine Small, Jejunum (47) (47) (48) (47)
Leiomyosarcoma 1 (2%)
Intestine Small, Ileum (46) (47) (48) (47)
Liver (50) (50) (50) (49)
Carcinoma, Metastatic, Thyroid Gland 1 (2%)
Hepatocellular Carcinoma 1 (2%)
Mesentery (8) (10) (12) (7)
Oral Mucosa (1)
Pharyngeal, Squamous Cell Papilloma 1 (100%)
Pancreas (50) (50) (49) (49)
Salivary Glands (50) (50) (50) (50)
Stomach, Glandular (50) (50) (50) (49)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (50) (50) (49) (50)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (50) (50) (49) (49)
Adenoma 1 (2%) 1 (2%) 1 (2%) 1 (2%)
Adrenal Medulla (50) (50) (49) (49)
Pheochromocytoma Complex 1 (2%)
Pheochromocytoma Benign 3 (6%) 3 (6%) 9 (18%) 4 (8%)
Bilateral, Pheochromocytoma Benign 1 (2%)
Page 2
NTP Experiment-Test: 88070-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC ISOBUTENE Date: 06/11/97
Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 10:30:48
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE CONTROL 500 PPM 2000 PPM 8000 PPM
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM - cont
Islets, Pancreatic (50) (50) (49) (49)
Adenoma 1 (2%)
Pituitary Gland (50) (49) (50) (49)
Pars Distalis, Adenoma 39 (78%) 33 (67%) 37 (74%) 36 (73%)
Thyroid Gland (50) (50) (49) (49)
C-Cell, Adenoma 7 (14%) 6 (12%) 3 (6%) 5 (10%)
C-Cell, Carcinoma 2 (4%) 3 (6%) 6 (12%) 2 (4%)
Follicular Cell, Carcinoma 1 (2%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Clitoral Gland (50) (49) (47) (48)
Adenoma 3 (6%) 3 (6%) 6 (13%)
Carcinoma 5 (11%) 1 (2%)
Bilateral, Carcinoma 1 (2%)
Ovary (50) (50) (50) (50)
Granulosa Cell Tumor Malignant 1 (2%)
Uterus (50) (50) (50) (50)
Polyp Stromal 7 (14%) 9 (18%) 7 (14%) 4 (8%)
Polyp Stromal, Multiple 1 (2%) 1 (2%) 1 (2%)
Vagina (1) (1) (1)
Polyp 1 (100%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (50) (50) (49) (49)
Lymph Node (6) (3) (3) (2)
Deep Cervical, Carcinoma, Metastatic,
Thyroid Gland 1 (50%)
Renal, Sarcoma 1 (17%)
Lymph Node, Bronchial (36) (31) (36) (27)
Lymph Node, Mandibular (44) (46) (47) (47)
Lymph Node, Mesenteric (50) (50) (49) (49)
Lymph Node, Mediastinal (42) (45) (39) (45)
Plasma Cell Tumor Malignant 1 (2%)
Spleen (50) (50) (49) (50)
Hemangiosarcoma 1 (2%)
Thymus (48) (47) (45) (41)
____________________________________________________________________________________________________________________________________
Page 3
NTP Experiment-Test: 88070-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC ISOBUTENE Date: 06/11/97
Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 10:30:48
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE CONTROL 500 PPM 2000 PPM 8000 PPM
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (50) (50) (50) (50)
Adenoma 1 (2%) 1 (2%) 1 (2%)
Carcinoma 2 (4%) 2 (4%) 4 (8%) 4 (8%)
Fibroadenoma 16 (32%) 14 (28%) 24 (48%) 22 (44%)
Fibroadenoma, Multiple 6 (12%) 5 (10%) 6 (12%) 5 (10%)
Skin (50) (50) (50) (50)
Keratoacanthoma 1 (2%) 1 (2%)
Squamous Cell Papilloma 1 (2%)
Subcutaneous Tissue, Fibroma 1 (2%) 1 (2%)
Subcutaneous Tissue, Fibrosarcoma 1 (2%)
Subcutaneous Tissue, Fibrous Histiocytoma
Malignant 1 (2%)
Subcutaneous Tissue, Hemangioma 1 (2%)
Subcutaneous Tissue, Melanoma Malignant 1 (2%)
Subcutaneous Tissue, Sarcoma 1 (2%) 2 (4%)
Subcutaneous Tissue, Schwannoma Malignant 1 (2%)
Subcutaneous Tissue, Pinna, Melanoma
Malignant 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (50) (50) (50) (50)
Osteosarcoma 1 (2%)
Sarcoma 1 (2%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (50) (50) (50)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (50) (50) (50)
Adenoma 1 (2%)
Alveolar/Bronchiolar Adenoma 2 (4%)
Carcinoma, Metastatic, Mammary Gland 1 (2%)
Carcinoma, Metastatic, Thyroid Gland 2 (4%) 1 (2%)
Fibrosarcoma, Metastatic, Skin 1 (2%)
Plasma Cell Tumor Malignant, Metastatic,
Lymph Node, Mediastinal 1 (2%)
Mediastinum, Plasma Cell Tumor Malignant,
Metastatic, Lymph Node, Mediastinal 1 (2%)
Nose (50) (50) (50) (49)
____________________________________________________________________________________________________________________________________
Page 4
NTP Experiment-Test: 88070-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC ISOBUTENE Date: 06/11/97
Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 10:30:48
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE CONTROL 500 PPM 2000 PPM 8000 PPM
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Zymbal's Gland (1)
Carcinoma 1 (100%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (50) (49) (49)
Lipoma 1 (2%)
Stromal Nephroma 1 (2%)
Renal Tubule, Carcinoma 1 (2%)
Urinary Bladder (50) (49) (49) (49)
Transitional Epithelium, Papilloma 1 (2%)
____________________________________________________________________________________________________________________________________
SYSTEMIC LESIONS
Multiple Organs *(50) *(50) *(50) *(50)
Leukemia Mononuclear 18 (36%) 16 (32%) 22 (44%) 17 (34%)
____________________________________________________________________________________________________________________________________
* Number of animals with any tissue examined microscopically
Page 5
NTP Experiment-Test: 88070-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC ISOBUTENE Date: 06/11/97
Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 10:30:48
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE CONTROL 500 PPM 2000 PPM 8000 PPM
____________________________________________________________________________________________________________________________________
TUMOR SUMMARY
Total Animals with Primary Neoplasms (b) 50 48 49 48
Total Primary Neoplasms 125 102 140 107
Total Animals with Benign Neoplasms 42 45 48 46
Total Benign Neoplasms 92 76 100 80
Total Animals with Malignant Neoplasms 30 24 30 25
Total Malignant Neoplasms 33 26 40 27
Total Animals with Metastatic Neoplasms 2 2 2 1
Total Metastatic Neoplasm 3 2 2 2
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: 88070-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC ISOBUTENE Date: 06/11/97
Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 10:30:48
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE CONTROL 500 PPM 2000 PPM 8000 PPM
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially in Study 50 50 50 50
Early Deaths
Moribund Sacrifice 39 40 37 41
Natural Death 4 5 7 1
Survivors
Terminal Sacrifice 7 5 6 8
Animals Examined Microscopically 50 50 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Intestine Large, Colon (49) (48) (48) (49)
Intestine Large, Rectum (47) (49) (49) (49)
Polyp Adenomatous 1 (2%)
Intestine Large, Cecum (48) (47) (49) (49)
Intestine Small, Jejunum (47) (46) (47) (49)
Carcinoma 1 (2%) 1 (2%)
Hemangiosarcoma 1 (2%)
Intestine Small, Ileum (47) (46) (47) (49)
Leiomyosarcoma 1 (2%)
Liver (50) (50) (50) (50)
Histiocytic Sarcoma 1 (2%) 2 (4%)
Osteosarcoma, Metastatic, Bone 1 (2%)
Mesentery (15) (10) (8) (11)
Liposarcoma 1 (10%)
Oral Mucosa (1)
Pharyngeal, Squamous Cell Papilloma 1 (100%)
Pancreas (50) (50) (50) (50)
Adenoma 2 (4%) 1 (2%)
Salivary Glands (50) (50) (50) (50)
Stomach, Forestomach (50) (50) (50) (50)
Stomach, Glandular (50) (49) (50) (50)
Tongue (1) (1)
Hemangiosarcoma 1 (100%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (50) (50) (50) (50)
____________________________________________________________________________________________________________________________________
Page 7
NTP Experiment-Test: 88070-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC ISOBUTENE Date: 06/11/97
Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 10:30:48
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE CONTROL 500 PPM 2000 PPM 8000 PPM
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (50) (49) (50) (50)
Adenoma 1 (2%) 1 (2%)
Osteosarcoma, Metastatic, Bone 1 (2%)
Adrenal Medulla (50) (49) (50) (50)
Pheochromocytoma Malignant 1 (2%) 1 (2%) 2 (4%)
Pheochromocytoma Benign 13 (26%) 7 (14%) 8 (16%) 11 (22%)
Bilateral, Pheochromocytoma Malignant 1 (2%)
Bilateral, Pheochromocytoma Benign 10 (20%) 11 (22%) 8 (16%) 12 (24%)
Islets, Pancreatic (50) (49) (50) (50)
Adenoma 4 (8%) 1 (2%) 4 (8%)
Carcinoma 4 (8%) 2 (4%) 1 (2%) 4 (8%)
Pituitary Gland (50) (49) (50) (49)
Pars Distalis, Adenoma 43 (86%) 40 (82%) 40 (80%) 41 (84%)
Thyroid Gland (48) (48) (48) (50)
C-Cell, Adenoma 5 (10%) 4 (8%) 5 (10%) 7 (14%)
C-Cell, Carcinoma 2 (4%) 1 (2%)
Follicular Cell, Carcinoma 1 (2%) 5 (10%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Epididymis (50) (50) (50) (50)
Preputial Gland (50) (50) (49) (50)
Adenoma 4 (8%) 2 (4%) 2 (4%) 1 (2%)
Carcinoma 1 (2%) 2 (4%) 2 (4%) 3 (6%)
Bilateral, Carcinoma 1 (2%)
Prostate (50) (49) (50) (50)
Adenoma 1 (2%)
Seminal Vesicle (50) (47) (50) (50)
Testes (50) (50) (50) (50)
Bilateral, Interstitial Cell, Adenoma 13 (26%) 14 (28%) 17 (34%) 14 (28%)
Interstitial Cell, Adenoma 10 (20%) 14 (28%) 12 (24%) 11 (22%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (50) (48) (50) (50)
Histiocytic Sarcoma 2 (4%)
Lymph Node (4) (11) (10) (10)
Histiocytic Sarcoma 1 (25%) 1 (10%)
Iliac, Osteosarcoma, Metastatic, Bone 1 (25%)
Page 8
NTP Experiment-Test: 88070-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC ISOBUTENE Date: 06/11/97
Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 10:30:48
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE CONTROL 500 PPM 2000 PPM 8000 PPM
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - cont
Pancreatic, Histiocytic Sarcoma 1 (10%)
Lymph Node, Bronchial (30) (41) (35) (45)
Histiocytic Sarcoma 1 (3%) 2 (6%)
Lymph Node, Mandibular (47) (47) (49) (49)
Lymph Node, Mesenteric (50) (50) (49) (50)
Lymph Node, Mediastinal (46) (42) (44) (45)
Carcinoma, Metastatic, Thyroid Gland 1 (2%)
Histiocytic Sarcoma 1 (2%)
Spleen (50) (49) (50) (50)
Histiocytic Sarcoma 1 (2%)
Thymus (40) (42) (38) (42)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (41) (41) (40) (44)
Carcinoma 1 (2%)
Carcinoma, Multiple 1 (2%)
Fibroadenoma 1 (2%) 1 (3%) 1 (2%)
Skin (50) (50) (50) (50)
Basal Cell Adenoma 2 (4%)
Basal Cell Carcinoma 2 (4%)
Keratoacanthoma 3 (6%) 4 (8%) 2 (4%) 4 (8%)
Squamous Cell Papilloma 1 (2%) 2 (4%) 1 (2%)
Sebaceous Gland, Adenoma 2 (4%) 1 (2%)
Subcutaneous Tissue, Fibroma 1 (2%) 2 (4%)
Subcutaneous Tissue, Histiocytic Sarcoma 1 (2%)
Subcutaneous Tissue, Lipoma 1 (2%)
Subcutaneous Tissue, Rhabdomyosarcoma 1 (2%)
Subcutaneous Tissue, Sarcoma 1 (2%)
Subcutaneous Tissue, Schwannoma Benign 1 (2%)
Subcutaneous Tissue, Schwannoma Malignant 1 (2%)
Subcutaneous Tissue, Pinna, Melanoma
Malignant 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (50) (50) (50) (50)
Osteosarcoma 1 (2%) 1 (2%)
Skeletal Muscle (1) (1) (1)
Histiocytic Sarcoma 1 (100%)
____________________________________________________________________________________________________________________________________
Page 9
NTP Experiment-Test: 88070-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC ISOBUTENE Date: 06/11/97
Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 10:30:48
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE CONTROL 500 PPM 2000 PPM 8000 PPM
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (50) (50) (50)
Astrocytoma Malignant 1 (2%)
Histiocytic Sarcoma 1 (2%)
Oligodendroglioma Malignant 1 (2%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (50) (50) (50)
Alveolar/Bronchiolar Adenoma 2 (4%) 2 (4%) 2 (4%)
Alveolar/Bronchiolar Carcinoma 2 (4%) 1 (2%) 1 (2%)
Carcinoma, Metastatic, Thyroid Gland 1 (2%)
Histiocytic Sarcoma 1 (2%) 2 (4%)
Osteosarcoma, Metastatic, Bone 1 (2%)
Mediastinum, Alveolar/Bronchiolar Carcinoma,
Metastatic, Lung 1 (2%)
Nose (49) (49) (50) (49)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (3) (4)
Zymbal's Gland (2) (1)
Carcinoma 2 (100%) 1 (100%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (50) (50) (50)
Histiocytic Sarcoma 1 (2%)
Stromal Nephroma 1 (2%) 1 (2%)
Renal Tubule, Adenoma 2 (4%) 1 (2%) 2 (4%)
Renal Tubule, Carcinoma 2 (4%)
Urinary Bladder (50) (49) (50) (50)
____________________________________________________________________________________________________________________________________
SYSTEMIC LESIONS
Multiple Organs *(50) *(50) *(50) *(50)
Histiocytic Sarcoma 1 (2%) 2 (4%)
Leukemia Mononuclear 21 (42%) 21 (42%) 20 (40%) 31 (62%)
Mesothelioma Malignant 3 (6%) 2 (4%)
____________________________________________________________________________________________________________________________________
* Number of animals with any tissue examined microscopically
Page 10
NTP Experiment-Test: 88070-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC ISOBUTENE Date: 06/11/97
Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 10:30:48
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE CONTROL 500 PPM 2000 PPM 8000 PPM
____________________________________________________________________________________________________________________________________
TUMOR SUMMARY
Total Animals with Primary Neoplasms (b) 50 48 49 50
Total Primary Neoplasms 155 143 138 165
Total Animals with Benign Neoplasms 48 46 49 49
Total Benign Neoplasms 117 103 104 113
Total Animals with Malignant Neoplasms 31 33 28 40
Total Malignant Neoplasms 38 40 34 52
Total Animals with Metastatic Neoplasms 1 1 1
Total Metastatic Neoplasm 4 1 2
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 11
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