TDMS Study 60968-01 Pathology Tables
NTP Experiment-Test: 60968-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC ISOBUTYRALDEHYDE Date: 08/06/96
Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 15:52:52
CORE STUDY
Facility: Battelle Northwest
Chemical CAS #: 0078-84-2
Lock Date: 06/01/94
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: 60968-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC ISOBUTYRALDEHYDE Date: 08/06/96
Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 15:52:52
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE CONTROL 500 PPM 1000 PPM 2000 PPM
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially in Study 50 50 50 50
Early Deaths
Moribund Sacrifice 17 22 22 13
Natural Death 6 3 4 5
Accidently Killed 1
Survivors
Terminal Sacrifice 27 24 24 31
Natural Death 1
Animals Examined Microscopically 50 50 50 50
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ALIMENTARY SYSTEM
Esophagus (49) (50) (50) (50)
Intestine Small, Duodenum (48) (47) (49) (47)
Intestine Small, Jejunum (47) (47) (49) (45)
Carcinoma 1 (2%)
Intestine Small, Ileum (47) (47) (49) (45)
Liver (49) (50) (50) (50)
Fibrous Histiocytoma, Metastatic, Skin 1 (2%)
Hepatocellular Adenoma 1 (2%) 2 (4%)
Mesentery (7) (7) (8) (4)
Fibrosarcoma 1 (14%)
Sarcoma 1 (14%)
Oral Mucosa (4) (2) (3)
Pharyngeal, Squamous Cell Carcinoma 1 (33%)
Pancreas (49) (49) (49) (50)
Stomach, Forestomach (49) (49) (50) (50)
Stomach, Glandular (48) (49) (50) (50)
Tongue (1) (1) (2)
Squamous Cell Papilloma 1 (100%) 1 (100%) 1 (50%)
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CARDIOVASCULAR SYSTEM
Heart (50) (50) (50) (50)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (49) (49) (50) (50)
Adenoma 1 (2%) 1 (2%) 2 (4%)
Fibrous Histiocytoma, Metastatic, Skin 1 (2%)
Adrenal Medulla (49) (49) (47) (49)
Page 2
NTP Experiment-Test: 60968-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC ISOBUTYRALDEHYDE Date: 08/06/96
Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 15:52:52
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE CONTROL 500 PPM 1000 PPM 2000 PPM
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM - cont
Pheochromocytoma Malignant 1 (2%)
Pheochromocytoma Benign 1 (2%) 2 (4%)
Islets, Pancreatic (50) (48) (49) (50)
Adenoma 2 (4%) 1 (2%) 1 (2%)
Carcinoma 1 (2%)
Pituitary Gland (48) (50) (49) (50)
Carcinoma 1 (2%)
Pars Distalis, Adenoma 34 (71%) 28 (56%) 33 (67%) 29 (58%)
Thyroid Gland (49) (49) (50) (50)
C-Cell, Adenoma 1 (2%) 4 (8%) 2 (4%) 3 (6%)
C-Cell, Carcinoma 1 (2%)
Follicular Cell, Adenoma 1 (2%)
Follicular Cell, Carcinoma 1 (2%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Clitoral Gland (48) (50) (50) (48)
Adenoma 1 (2%) 2 (4%) 1 (2%)
Carcinoma 4 (8%) 5 (10%) 4 (8%) 3 (6%)
Ovary (49) (50) (50) (50)
Granulosa-Theca Tumor Malignant 1 (2%) 1 (2%)
Bilateral, Fibrous Histiocytoma, Metastatic,
Skin 1 (2%)
Uterus (48) (50) (50) (50)
Leiomyoma 1 (2%)
Leiomyosarcoma 1 (2%)
Polyp Stromal 2 (4%) 5 (10%) 1 (2%) 6 (12%)
Sarcoma Stromal 2 (4%) 1 (2%)
Vagina (1)
Polyp 1 (100%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (49) (49) (50) (50)
Fibrous Histiocytoma, Metastatic, Skin 1 (2%)
Lymph Node (4) (4) (4) (5)
Fibrous Histiocytoma, Metastatic, Skin 1 (25%)
Lymph Node, Bronchial (49) (50) (50) (50)
Fibrous Histiocytoma, Metastatic, Skin 1 (2%)
Lymph Node, Mandibular (45) (50) (46) (46)
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NTP Experiment-Test: 60968-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC ISOBUTYRALDEHYDE Date: 08/06/96
Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 15:52:52
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE CONTROL 500 PPM 1000 PPM 2000 PPM
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - cont
Fibrous Histiocytoma, Metastatic, Skin 1 (2%)
Lymph Node, Mesenteric (49) (50) (50) (50)
Lymph Node, Mediastinal (48) (49) (50) (50)
Fibrous Histiocytoma, Metastatic, Skin 1 (2%)
Spleen (49) (49) (49) (50)
Hemangiosarcoma 1 (2%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (50) (50) (50) (50)
Carcinoma 1 (2%) 1 (2%) 5 (10%) 1 (2%)
Carcinoma, Multiple 1 (2%)
Fibroadenoma 23 (46%) 17 (34%) 19 (38%) 17 (34%)
Fibroadenoma, Multiple 4 (8%) 4 (8%) 5 (10%) 7 (14%)
Skin (49) (50) (50) (50)
Keratoacanthoma 1 (2%) 1 (2%)
Lipoma 1 (2%)
Trichoepithelioma 1 (2%)
Pinna, Schwannoma Benign 1 (2%)
Sebaceous Gland, Adenoma 2 (4%)
Sebaceous Gland, Carcinoma 1 (2%)
Subcutaneous Tissue, Fibroma 1 (2%) 2 (4%)
Subcutaneous Tissue, Fibrous Histiocytoma 1 (2%)
Subcutaneous Tissue, Lipoma 1 (2%)
Subcutaneous Tissue, Osteosarcoma 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (49) (50) (50) (50)
Rib, Osteosarcoma 1 (2%)
Vertebra, Chordoma 1 (2%)
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NERVOUS SYSTEM
Brain (49) (49) (50) (50)
Astrocytoma Malignant 1 (2%)
Carcinoma, Metastatic, Pituitary Gland 1 (2%)
Granular Cell Tumor Benign 1 (2%)
____________________________________________________________________________________________________________________________________
Page 4
NTP Experiment-Test: 60968-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC ISOBUTYRALDEHYDE Date: 08/06/96
Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 15:52:52
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE CONTROL 500 PPM 1000 PPM 2000 PPM
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Larynx (49) (50) (48) (50)
Lung (49) (50) (50) (50)
Alveolar/Bronchiolar Adenoma 1 (2%) 3 (6%)
Alveolar/Bronchiolar Carcinoma 1 (2%)
Chordoma, Metastatic, Tissue NOS 1 (2%) 1 (2%)
Fibrous Histiocytoma, Metastatic, Skin 1 (2%)
Nose (49) (50) (49) (50)
Sarcoma 1 (2%)
Pleura (1) (1)
Osteosarcoma, Metastatic, Bone 1 (100%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
None
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (49) (49) (50) (50)
Renal Tubule, Adenoma 1 (2%)
Urinary Bladder (49) (49) (50) (50)
____________________________________________________________________________________________________________________________________
SYSTEMIC LESIONS
Multiple Organs *(50) *(50) *(50) *(50)
Leukemia Mononuclear 12 (24%) 19 (38%) 18 (36%) 25 (50%)
Lymphoma Malignant 2 (4%)
____________________________________________________________________________________________________________________________________
* Number of animals with any tissue examined microscopically
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NTP Experiment-Test: 60968-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC ISOBUTYRALDEHYDE Date: 08/06/96
Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 15:52:52
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE CONTROL 500 PPM 1000 PPM 2000 PPM
____________________________________________________________________________________________________________________________________
TUMOR SUMMARY
Total Animals with Primary Neoplasms (b) 48 49 50 49
Total Primary Neoplasms 97 98 102 113
Total Animals with Benign Neoplasms 44 37 44 41
Total Benign Neoplasms 73 64 69 79
Total Animals with Malignant Neoplasms 21 30 25 30
Total Malignant Neoplasms 24 34 33 34
Total Animals with Metastatic Neoplasms 3 1 1
Total Metastatic Neoplasm 11 1 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 6
NTP Experiment-Test: 60968-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC ISOBUTYRALDEHYDE Date: 08/06/96
Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 15:52:52
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE CONTROL 500 PPM 1000 PPM 2000 PPM
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially in Study 50 50 50 50
Early Deaths
Natural Death 3 3 5 5
Moribund Sacrifice 35 32 34 35
Survivors
Terminal Sacrifice 12 15 11 10
Animals Examined Microscopically 50 50 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Intestine Large, Colon (50) (49) (49) (50)
Polyp Adenomatous 1 (2%)
Intestine Large, Rectum (50) (47) (49) (50)
Polyp Adenomatous 1 (2%)
Intestine Large, Cecum (47) (49) (48) (48)
Intestine Small, Duodenum (50) (49) (49) (49)
Intestine Small, Ileum (48) (49) (48) (47)
Carcinoma 1 (2%) 1 (2%)
Liver (50) (49) (50) (50)
Hepatocellular Carcinoma 2 (4%)
Mesentery (11) (12) (8) (10)
Oral Mucosa (3) (2) (2)
Squamous Cell Papilloma 1 (33%) 1 (50%)
Pharyngeal, Squamous Cell Papilloma 1 (50%)
Pancreas (50) (48) (50) (50)
Adenoma 1 (2%)
Stomach, Forestomach (50) (49) (50) (50)
Leiomyosarcoma 1 (2%)
Stomach, Glandular (50) (49) (50) (50)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (50) (49) (50) (50)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (50) (49) (50) (50)
Adrenal Medulla (49) (49) (50) (50)
Pheochromocytoma Malignant 3 (6%) 1 (2%) 1 (2%)
Pheochromocytoma Benign 7 (14%) 11 (22%) 9 (18%) 11 (22%)
Bilateral, Pheochromocytoma Benign 4 (8%) 1 (2%) 3 (6%) 4 (8%)
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NTP Experiment-Test: 60968-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC ISOBUTYRALDEHYDE Date: 08/06/96
Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 15:52:52
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE CONTROL 500 PPM 1000 PPM 2000 PPM
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM - cont
Islets, Pancreatic (50) (49) (50) (50)
Adenoma 1 (2%) 3 (6%) 1 (2%) 3 (6%)
Carcinoma 2 (4%) 1 (2%) 1 (2%) 1 (2%)
Pituitary Gland (50) (49) (49) (50)
Pars Distalis, Adenoma 41 (82%) 27 (55%) 37 (76%) 34 (68%)
Thyroid Gland (50) (49) (50) (50)
Bilateral, C-Cell, Adenoma 1 (2%)
C-Cell, Adenoma 1 (2%) 1 (2%) 4 (8%) 1 (2%)
C-Cell, Adenoma, Multiple 1 (2%)
C-Cell, Carcinoma 3 (6%) 1 (2%) 1 (2%) 1 (2%)
Follicular Cell, Carcinoma 2 (4%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
Peritoneum (2) (1)
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Epididymis (50) (49) (50) (50)
Preputial Gland (50) (49) (50) (50)
Adenoma 2 (4%) 1 (2%)
Carcinoma 2 (4%) 2 (4%) 4 (8%) 3 (6%)
Prostate (50) (49) (50) (50)
Seminal Vesicle (50) (49) (50) (50)
Testes (50) (50) (50) (50)
Bilateral, Interstitial Cell, Adenoma 18 (36%) 31 (62%) 20 (40%) 16 (32%)
Interstitial Cell, Adenoma 12 (24%) 12 (24%) 10 (20%) 20 (40%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (50) (49) (50) (50)
Lymph Node (15) (10) (6) (7)
Lymph Node, Bronchial (50) (46) (49) (50)
Lymph Node, Mandibular (46) (46) (44) (44)
Lymph Node, Mesenteric (50) (49) (50) (50)
Lymph Node, Mediastinal (49) (49) (50) (50)
Spleen (50) (49) (50) (50)
Fibrosarcoma 1 (2%)
Hemangiosarcoma 1 (2%)
Thymus (50) (49) (50) (49)
Thymoma Benign 1 (2%)
Thymoma Malignant 2 (4%)
____________________________________________________________________________________________________________________________________
Page 8
NTP Experiment-Test: 60968-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC ISOBUTYRALDEHYDE Date: 08/06/96
Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 15:52:52
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE CONTROL 500 PPM 1000 PPM 2000 PPM
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (50) (49) (50) (50)
Fibroadenoma 1 (2%) 2 (4%) 1 (2%) 1 (2%)
Skin (50) (50) (50) (50)
Basal Cell Adenoma 1 (2%)
Keratoacanthoma 1 (2%) 4 (8%) 3 (6%) 2 (4%)
Schwannoma Malignant 1 (2%)
Squamous Cell Papilloma 2 (4%)
Trichoepithelioma 1 (2%) 1 (2%)
Epidermis, Keratoacanthoma 1 (2%)
Sebaceous Gland, Adenoma 1 (2%)
Subcutaneous Tissue, Fibroma 3 (6%) 1 (2%) 1 (2%) 4 (8%)
Subcutaneous Tissue, Fibrosarcoma 1 (2%) 1 (2%)
Subcutaneous Tissue, Lipoma 1 (2%) 1 (2%)
Subcutaneous Tissue, Sarcoma 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Skeletal Muscle (1)
Sarcoma 1 (100%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (50) (50) (50)
Spinal Cord (1) (1) (1)
Schwannoma Malignant 1 (100%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (49) (50) (50)
Alveolar/Bronchiolar Adenoma 1 (2%) 2 (4%)
Epithelioma Benign 1 (2%)
Nose (50) (49) (49) (50)
Adenoma 1 (2%)
Vomeronasal Organ, Adenoma 1 (2%)
Pleura (1) (1)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Zymbal's Gland (2) (1) (1) (1)
Carcinoma 1 (50%) 1 (100%) 1 (100%)
____________________________________________________________________________________________________________________________________
Page 9
NTP Experiment-Test: 60968-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC ISOBUTYRALDEHYDE Date: 08/06/96
Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 15:52:52
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE CONTROL 500 PPM 1000 PPM 2000 PPM
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (49) (50) (50)
Urinary Bladder (50) (48) (50) (50)
Transitional Epithelium, Carcinoma 1 (2%)
____________________________________________________________________________________________________________________________________
SYSTEMIC LESIONS
Multiple Organs *(50) *(50) *(50) *(50)
Leukemia Mononuclear 33 (66%) 32 (64%) 23 (46%) 34 (68%)
Lymphoma Malignant 1 (2%) 1 (2%)
Mesothelioma Benign 1 (2%)
Mesothelioma Malignant 2 (4%) 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
* Number of animals with any tissue examined microscopically
Page 10
NTP Experiment-Test: 60968-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC ISOBUTYRALDEHYDE Date: 08/06/96
Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 15:52:52
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE CONTROL 500 PPM 1000 PPM 2000 PPM
____________________________________________________________________________________________________________________________________
TUMOR SUMMARY
Total Animals with Primary Neoplasms (b) 50 49 49 50
Total Primary Neoplasms 141 147 138 145
Total Animals with Benign Neoplasms 47 49 46 49
Total Benign Neoplasms 93 103 97 102
Total Animals with Malignant Neoplasms 40 38 33 36
Total Malignant Neoplasms 48 44 41 43
Total Animals with Metastatic Neoplasms
Total Metastatic Neoplasm
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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