TDMS Study 05185-03 Pathology Tables
INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)
ISOBUTYL NITRITE (IBN)
NTP Experiment-Test: 05185-03 Report: PEIRPT05
Study Type: CHRONIC Date: 05/20/95
Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 10:47:26
Facility: I. I. T. Research Institute
Chemical CAS #: 542-56-3
Lock Date: 05/22/92
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: 05185-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC ISOBUTYL NITRITE (IBN) Date: 05/20/95
Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 10:47:26
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE CONTROL 37.5 PPM 75 PPM 150 PPM
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially in Study 56 56 56 56
Scheduled Sacrifice 10 10 10 10
Early Deaths
Moribund Sacrifice 13 4 7 6
Natural Death 4 6 8 7
Survivors
Terminal Sacrifice 29 35 30 33
Natural Death 1
Missing 1
Animals Examined Microscopically 56 55 56 56
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Intestine Large, Cecum (56) (54) (53) (53)
Intestine Small, Ileum (54) (51) (50) (51)
Liver (56) (54) (56) (56)
Hepatocellular Adenoma 1 (2%)
Histiocytic Sarcoma 1 (2%) 1 (2%)
Pancreas (56) (55) (56) (56)
Stomach, Forestomach (56) (55) (56) (56)
Stomach, Glandular (56) (54) (55) (56)
Tongue (1) (1) (2) (1)
Squamous Cell Carcinoma 1 (100%) 1 (50%) 1 (100%)
Squamous Cell Papilloma 1 (100%) 1 (50%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (56) (55) (56) (56)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (56) (55) (56) (56)
Adenoma 1 (2%)
Adrenal Medulla (55) (55) (55) (56)
Pheochromocytoma Complex 2 (4%)
Pheochromocytoma Benign 3 (5%) 1 (2%) 2 (4%)
Bilateral, Pheochromocytoma Malignant 1 (2%)
Islets, Pancreatic (6) (1) (1)
Adenoma 5 (83%) 1 (100%) 1 (100%)
Pituitary Gland (56) (53) (55) (56)
Page 2
NTP Experiment-Test: 05185-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC ISOBUTYL NITRITE (IBN) Date: 05/20/95
Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 10:47:26
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE CONTROL 37.5 PPM 75 PPM 150 PPM
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM - cont
Pars Distalis, Adenoma 24 (43%) 16 (30%) 19 (35%) 17 (30%)
Pars Distalis, Adenoma, Multiple 2 (4%) 1 (2%) 1 (2%)
Pars Distalis, Carcinoma 1 (2%) 1 (2%)
Thyroid Gland (56) (55) (56) (56)
Bilateral, C-Cell, Adenoma 1 (2%)
C-Cell, Adenoma 1 (2%) 3 (5%) 2 (4%) 3 (5%)
C-Cell, Carcinoma 2 (4%)
Follicular Cell, Carcinoma 2 (4%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Clitoral Gland (54) (54) (54) (56)
Adenoma 1 (2%) 1 (2%) 1 (2%) 1 (2%)
Carcinoma 1 (2%)
Bilateral, Adenoma 1 (2%)
Ovary (56) (55) (56) (56)
Granulosa Cell Tumor Benign 1 (2%)
Histiocytic Sarcoma 1 (2%)
Uterus (56) (55) (56) (56)
Polyp Stromal 1 (2%) 5 (9%) 3 (5%) 2 (4%)
Sarcoma Stromal 1 (2%)
Bilateral, Polyp Stromal 1 (2%) 3 (5%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (56) (55) (56) (56)
Histiocytic Sarcoma 1 (2%)
Lymph Node (1) (1) (3)
Lymph Node, Bronchial (36) (40) (46) (38)
Histiocytic Sarcoma 1 (2%)
Rhabdomyosarcoma, Metastatic, Uncertain
Primary Site 1 (3%)
Lymph Node, Mandibular (55) (55) (53) (53)
Histiocytic Sarcoma 1 (2%)
Lymph Node, Mesenteric (56) (55) (56) (55)
Histiocytic Sarcoma 1 (2%)
Lymph Node, Mediastinal (54) (54) (51) (53)
Histiocytic Sarcoma 1 (2%)
Spleen (56) (55) (54) (56)
Hemangiosarcoma 1 (2%)
Page 3
NTP Experiment-Test: 05185-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC ISOBUTYL NITRITE (IBN) Date: 05/20/95
Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 10:47:26
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE CONTROL 37.5 PPM 75 PPM 150 PPM
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - cont
Histiocytic Sarcoma 1 (2%)
Thymus (54) (53) (55) (54)
Histiocytic Sarcoma 1 (2%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (56) (55) (56) (56)
Adenocarcinoma 3 (5%) 1 (2%) 1 (2%) 1 (2%)
Adenoma 1 (2%) 1 (2%)
Fibroadenoma 9 (16%) 8 (15%) 16 (29%) 13 (23%)
Fibroadenoma, Multiple 3 (5%) 6 (11%) 4 (7%)
Skin (56) (55) (56) (56)
Squamous Cell Papilloma 1 (2%)
Subcutaneous Tissue, Fibroma 2 (4%) 1 (2%)
Subcutaneous Tissue, Fibrosarcoma 1 (2%)
Subcutaneous Tissue, Lipoma 1 (2%) 1 (2%)
Tail, Squamous Cell Papilloma 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
None
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (56) (55) (56) (56)
Astrocytoma Benign 1 (2%)
Carcinoma, Metastatic, Pituitary Gland 1 (2%) 1 (2%)
Glioma Malignant 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Larynx (56) (55) (56) (56)
Lung (56) (55) (56) (56)
Alveolar/Bronchiolar Adenoma 2 (4%) 2 (4%) 8 (14%)
Alveolar/Bronchiolar Adenoma, Multiple 2 (4%)
Alveolar/Bronchiolar Carcinoma 1 (2%) 1 (2%)
Mediastinum, Rhabdomyosarcoma, Metastatic,
Uncertain Primary Site 1 (2%)
Nose (56) (55) (55) (56)
____________________________________________________________________________________________________________________________________
Page 4
NTP Experiment-Test: 05185-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC ISOBUTYL NITRITE (IBN) Date: 05/20/95
Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 10:47:26
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE CONTROL 37.5 PPM 75 PPM 150 PPM
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
None
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (56) (55) (56) (56)
Sarcoma 1 (2%)
Urinary Bladder (56) (54) (55) (52)
____________________________________________________________________________________________________________________________________
SYSTEMIC LESIONS
Multiple Organs *(56) *(55) *(56) *(56)
Histiocytic Sarcoma 1 (2%) 1 (2%)
Leukemia Mononuclear 15 (27%) 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
* Number of animals with any tissue examined microscopically
Page 5
NTP Experiment-Test: 05185-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC ISOBUTYL NITRITE (IBN) Date: 05/20/95
Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 10:47:26
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE CONTROL 37.5 PPM 75 PPM 150 PPM
____________________________________________________________________________________________________________________________________
TUMOR SUMMARY
Total Animals with Primary Neoplasms (b) 44 36 37 35
Total Primary Neoplasms 75 61 61 61
Total Animals with Benign Neoplasms 35 36 35 34
Total Benign Neoplasms 49 54 55 54
Total Animals with Malignant Neoplasms 22 7 6 7
Total Malignant Neoplasms 26 7 6 7
Total Animals with Metastatic Neoplasms 1 1 1
Total Metastatic Neoplasm 1 1 2
Total Animals with Malignant Neoplasms 1
Uncertain Primary Site
Total Animals with Neoplasms Uncertain-
Benign or Malignant
Total Uncertain Neoplasms
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
b Primary tumors: all tumors except metastatic tumors
Page 6
NTP Experiment-Test: 05185-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC ISOBUTYL NITRITE (IBN) Date: 05/20/95
Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 10:47:26
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE CONTROL 37.5 PPM 75 PPM 150 PPM
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially in Study 56 56 56 56
Scheduled Sacrifice 10 10 10 10
Early Deaths
Moribund Sacrifice 21 12 5 8
Natural Death 8 11 4 10
Accidently Killed 1
Survivors
Terminal Sacrifice 17 23 36 28
Animals Examined Microscopically 56 56 56 56
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Esophagus (55) (56) (56) (56)
Intestine Large, Colon (55) (55) (56) (55)
Intestine Large, Rectum (54) (54) (55) (55)
Intestine Large, Cecum (54) (51) (54) (53)
Intestine Small, Duodenum (54) (54) (56) (55)
Intestine Small, Jejunum (54) (50) (54) (49)
Adenocarcinoma 1 (2%)
Intestine Small, Ileum (53) (46) (53) (52)
Liver (55) (56) (56) (56)
Hepatocellular Carcinoma 1 (2%)
Hepatocellular Adenoma 1 (2%) 1 (2%) 1 (2%)
Histiocytic Sarcoma, Metastatic, Skin 1 (2%)
Sarcoma, Metastatic, Skin 1 (2%)
Mesentery (6) (1) (4) (10)
Pancreas (55) (56) (56) (56)
Carcinoma, Metastatic, Kidney 1 (2%)
Salivary Glands (56) (55) (56) (56)
Stomach, Forestomach (55) (56) (56) (56)
Stomach, Glandular (55) (56) (56) (55)
Tongue (1) (1)
Squamous Cell Papilloma 1 (100%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (56) (56) (56) (56)
Alveolar/Bronchiolar Carcinoma, Metastatic,
Lung 1 (2%) 1 (2%)
Schwannoma Malignant 1 (2%)
____________________________________________________________________________________________________________________________________
Page 7
NTP Experiment-Test: 05185-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC ISOBUTYL NITRITE (IBN) Date: 05/20/95
Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 10:47:26
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE CONTROL 37.5 PPM 75 PPM 150 PPM
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (55) (56) (56) (56)
Adrenal Medulla (54) (55) (56) (56)
Pheochromocytoma Malignant 1 (2%) 4 (7%) 1 (2%)
Pheochromocytoma Benign 4 (7%) 8 (15%) 8 (14%) 14 (25%)
Bilateral, Pheochromocytoma Benign 4 (7%) 1 (2%)
Islets, Pancreatic (8) (9) (5) (5)
Adenoma 3 (38%) 6 (67%) 2 (40%) 4 (80%)
Carcinoma 1 (13%) 1 (20%)
Parathyroid Gland (49) (50) (48) (52)
Pituitary Gland (55) (56) (56) (55)
Pars Distalis, Adenoma 30 (55%) 24 (43%) 27 (48%) 28 (51%)
Pars Distalis, Adenoma, Multiple 1 (2%) 3 (5%) 2 (4%)
Pars Nervosa, Craniopharyngioma 1 (2%)
Thyroid Gland (55) (56) (56) (56)
C-Cell, Adenoma 1 (2%) 1 (2%) 5 (9%) 4 (7%)
C-Cell, Carcinoma 1 (2%) 1 (2%)
Follicular Cell, Carcinoma 1 (2%) 1 (2%) 2 (4%) 1 (2%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
Tissue NOS (3) (1)
Mediastinum, Carcinoma, Metastatic, Thyroid
Gland 1 (33%)
Thoracic, Alveolar/Bronchiolar Carcinoma,
Metastatic, Lung 1 (33%)
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Epididymis (56) (56) (56) (56)
Preputial Gland (54) (56) (56) (56)
Adenoma 3 (6%) 5 (9%) 3 (5%) 2 (4%)
Carcinoma 1 (2%)
Histiocytic Sarcoma, Metastatic, Skin 1 (2%)
Prostate (56) (56) (56) (56)
Seminal Vesicle (55) (56) (56) (56)
Testes (56) (56) (56) (56)
Bilateral, Interstitial Cell, Adenoma 20 (36%) 26 (46%) 25 (45%) 27 (48%)
Interstitial Cell, Adenoma 14 (25%) 8 (14%) 13 (23%) 12 (21%)
____________________________________________________________________________________________________________________________________
Page 8
NTP Experiment-Test: 05185-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC ISOBUTYL NITRITE (IBN) Date: 05/20/95
Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 10:47:26
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE CONTROL 37.5 PPM 75 PPM 150 PPM
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (55) (55) (56) (56)
Lymph Node (5) (1)
Lymph Node, Bronchial (47) (43) (40) (39)
Alveolar/Bronchiolar Carcinoma, Metastatic,
Lung 1 (2%) 1 (3%)
Carcinoma, Metastatic, Kidney 1 (2%)
Lymph Node, Mandibular (55) (55) (56) (56)
Alveolar/Bronchiolar Carcinoma, Metastatic,
Lung 1 (2%)
Lymph Node, Mesenteric (55) (56) (56) (54)
Lymph Node, Mediastinal (55) (52) (52) (55)
Alveolar/Bronchiolar Carcinoma, Metastatic,
Lung 1 (2%)
Carcinoma, Metastatic, Kidney 1 (2%)
Carcinoma, Metastatic, Zymbal's Gland 1 (2%)
Sarcoma, Metastatic, Skin 1 (2%)
Spleen (56) (55) (56) (55)
Fibroma 1 (2%)
Hemangiosarcoma 1 (2%) 1 (2%) 2 (4%)
Thymus (51) (56) (55) (54)
Alveolar/Bronchiolar Carcinoma, Metastatic,
Lung 1 (2%)
Thymoma Benign 1 (2%)
Thymoma Malignant 1 (2%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (52) (53) (56) (53)
Fibroadenoma 2 (4%) 1 (2%)
Skin (56) (56) (56) (56)
Keratoacanthoma 2 (4%) 2 (4%) 2 (4%)
Trichoepithelioma 1 (2%)
Back, Squamous Cell Carcinoma 1 (2%)
Head, Basosquamous Tumor Benign 1 (2%)
Inguinal, Squamous Cell Carcinoma 1 (2%)
Lip, Squamous Cell Carcinoma 1 (2%)
Pinna, Fibrosarcoma 1 (2%)
Subcutaneous Tissue, Fibroma 1 (2%) 2 (4%)
Subcutaneous Tissue, Histiocytic Sarcoma 1 (2%)
Subcutaneous Tissue, Lipoma 1 (2%)
Subcutaneous Tissue, Sarcoma 1 (2%)
Tail, Keratoacanthoma 1 (2%)
____________________________________________________________________________________________________________________________________
Page 9
NTP Experiment-Test: 05185-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC ISOBUTYL NITRITE (IBN) Date: 05/20/95
Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 10:47:26
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE CONTROL 37.5 PPM 75 PPM 150 PPM
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
None
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (56) (56) (56) (56)
Astrocytoma Malignant 1 (2%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Larynx (56) (56) (56) (56)
Lung (56) (56) (56) (56)
Alveolar/Bronchiolar Adenoma 3 (5%) 13 (23%) 11 (20%)
Alveolar/Bronchiolar Adenoma, Multiple 1 (2%) 3 (5%)
Alveolar/Bronchiolar Carcinoma 1 (2%) 2 (4%) 1 (2%) 6 (11%)
Carcinoma, Metastatic, Kidney 1 (2%)
Carcinoma, Metastatic, Zymbal's Gland 1 (2%) 1 (2%) 1 (2%)
Sarcoma, Metastatic, Skin 1 (2%)
Mediastinum, Alveolar/Bronchiolar Carcinoma,
Metastatic, Lung 1 (2%) 1 (2%)
Mediastinum, Carcinoma, Metastatic, Kidney 1 (2%)
Nose (55) (55) (56) (56)
Osteoma 1 (2%)
Respiratory Epithelium, Adenoma 1 (2%)
Trachea (56) (56) (56) (56)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Zymbal's Gland (3) (1) (1)
Carcinoma 3 (100%) 1 (100%) 1 (100%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (55) (55) (56) (56)
Bilateral, Carcinoma 1 (2%)
Urinary Bladder (56) (55) (56) (55)
Transitional Epithelium, Carcinoma 1 (2%)
Page 10
NTP Experiment-Test: 05185-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC ISOBUTYL NITRITE (IBN) Date: 05/20/95
Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 10:47:26
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE CONTROL 37.5 PPM 75 PPM 150 PPM
____________________________________________________________________________________________________________________________________
SYSTEMIC LESIONS
Multiple Organs *(56) *(56) *(56) *(56)
Histiocytic Sarcoma 1 (2%)
Leukemia Mononuclear 27 (48%) 2 (4%) 1 (2%) 1 (2%)
Mesothelioma Malignant 1 (2%) 1 (2%) 4 (7%) 2 (4%)
____________________________________________________________________________________________________________________________________
* Number of animals with any tissue examined microscopically
Page 11
NTP Experiment-Test: 05185-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC ISOBUTYL NITRITE (IBN) Date: 05/20/95
Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 10:47:26
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE CONTROL 37.5 PPM 75 PPM 150 PPM
____________________________________________________________________________________________________________________________________
TUMOR SUMMARY
Total Animals with Primary Neoplasms (b) 54 53 52 56
Total Primary Neoplasms 122 107 120 132
Total Animals with Benign Neoplasms 50 52 49 54
Total Benign Neoplasms 83 91 105 115
Total Animals with Malignant Neoplasms 32 15 14 15
Total Malignant Neoplasms 39 16 15 17
Total Animals with Metastatic Neoplasms 5 2 5 6
Total Metastatic Neoplasm 16 3 5 17
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 12
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