TDMS Study 60968-02 Pathology Tables
NTP Experiment-Test: 60968-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC ISOBUTYRALDEHYDE Date: 09/23/96
Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 15:07:05
CORE STUDY
Facility: Battelle Northwest
Chemical CAS #: 0078-84-2
Lock Date: 05/12/94
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: 60968-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC ISOBUTYRALDEHYDE Date: 09/23/96
Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 15:07:05
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE CONTROL 500 PPM 1000 PPM 2000 PPM
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 50 50 50 50
Early Deaths
Moribund Sacrifice 16 13 11 11
Natural Death 5 4 3 2
Accidently Killed 1 1
Survivors
Terminal Sacrifice 28 32 35 37
Natural Death 1
Animals Examined Microscopically 50 50 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Gallbladder (46) (44) (45) (47)
Hyperplasia 1 (2%) 1 (2%)
Intestine Small, Ileum (49) (46) (47) (49)
Hyperplasia, Lymphoid 1 (2%) 1 (2%)
Liver (49) (49) (50) (50)
Angiectasis 2 (4%)
Basophilic Focus 1 (2%) 3 (6%) 2 (4%) 3 (6%)
Clear Cell Focus 1 (2%) 2 (4%)
Cyst 1 (2%) 1 (2%)
Eosinophilic Focus 6 (12%) 7 (14%) 5 (10%) 4 (8%)
Hematopoietic Cell Proliferation 1 (2%) 1 (2%)
Mixed Cell Focus 1 (2%)
Necrosis 4 (8%) 3 (6%) 1 (2%) 1 (2%)
Tension Lipidosis 3 (6%) 2 (4%)
Thrombosis 1 (2%)
Centrilobular, Necrosis 1 (2%) 2 (4%) 2 (4%)
Mesentery (8) (2) (4) (3)
Hemorrhage 1 (33%)
Fat, Necrosis 6 (75%) 2 (100%) 2 (67%)
Pancreas (50) (49) (50) (50)
Atrophy 1 (2%) 1 (2%)
Basophilic Focus 1 (2%)
Cyst 2 (4%) 1 (2%) 1 (2%)
Hypertrophy 1 (2%) 1 (2%)
Inflammation, Chronic Active 1 (2%) 1 (2%) 2 (4%)
Lipomatosis 4 (8%) 1 (2%) 3 (6%) 3 (6%)
Thrombosis 1 (2%)
Stomach, Forestomach (50) (50) (50) (50)
Diverticulum 1 (2%)
Hyperplasia, Squamous 1 (2%) 1 (2%) 3 (6%)
Inflammation, Chronic Active 1 (2%) 1 (2%) 1 (2%) 3 (6%)
Stomach, Glandular (49) (49) (50) (50)
a Number of animals examined microscopically at site and number of animals with lesion
Page 2
NTP Experiment-Test: 60968-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC ISOBUTYRALDEHYDE Date: 09/23/96
Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 15:07:05
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE CONTROL 500 PPM 1000 PPM 2000 PPM
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Inflammation, Chronic Active 1 (2%)
Mineralization 1 (2%)
Tooth (1)
Developmental Malformation 1 (100%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (50) (50) (50) (50)
Cardiomyopathy 9 (18%) 12 (24%) 10 (20%) 7 (14%)
Artery, Mineralization 1 (2%)
Atrium, Thrombosis 1 (2%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (50) (49) (50) (50)
Atrophy 1 (2%)
Degeneration, Fatty 2 (4%) 2 (4%) 1 (2%) 1 (2%)
Hyperplasia 5 (10%) 3 (6%) 1 (2%)
Hypertrophy 1 (2%) 1 (2%)
Necrosis 1 (2%)
Adrenal Medulla (50) (49) (50) (50)
Hyperplasia 5 (10%) 3 (6%) 2 (4%) 1 (2%)
Pituitary Gland (50) (49) (50) (49)
Pars Distalis, Hyperplasia 19 (38%) 23 (47%) 23 (46%) 17 (35%)
Pars Intermedia, Hyperplasia 1 (2%)
Pars Intermedia, Hypertrophy 1 (2%) 1 (2%)
Thyroid Gland (50) (50) (50) (50)
Follicular Cell, Hyperplasia 18 (36%) 26 (52%) 24 (48%) 32 (64%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Clitoral Gland (44) (39) (40) (40)
Inflammation, Chronic Active 1 (3%)
Ovary (50) (49) (50) (50)
Angiectasis 2 (4%)
Cyst 13 (26%) 15 (31%) 14 (28%) 18 (36%)
Hyperplasia 1 (2%)
Interstitial Cell, Hyperplasia 1 (2%)
Uterus (50) (50) (50) (50)
a Number of animals examined microscopically at site and number of animals with lesion
Page 3
NTP Experiment-Test: 60968-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC ISOBUTYRALDEHYDE Date: 09/23/96
Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 15:07:05
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE CONTROL 500 PPM 1000 PPM 2000 PPM
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM - CONT
Angiectasis 2 (4%) 1 (2%)
Hemorrhage 1 (2%)
Hydrometra 4 (8%) 4 (8%) 6 (12%) 7 (14%)
Inflammation, Suppurative 1 (2%)
Thrombosis 1 (2%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Lymph Node (5) (5) (4) (4)
Lumbar, Ectasia 1 (25%)
Lumbar, Hemorrhage 1 (25%)
Lymph Node, Bronchial (42) (38) (42) (44)
Hemorrhage 1 (2%)
Lymph Node, Mesenteric (48) (49) (47) (47)
Angiectasis 1 (2%)
Necrosis 1 (2%)
Spleen (50) (49) (50) (50)
Congestion 1 (2%)
Hematopoietic Cell Proliferation 11 (22%) 11 (22%) 11 (22%) 9 (18%)
Hyperplasia, Lymphoid 2 (4%) 2 (4%) 3 (6%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Skin (50) (50) (50) (50)
Inflammation, Acute 1 (2%)
Inflammation, Chronic Active 1 (2%)
Subcutaneous Tissue, Angiectasis 1 (2%)
Subcutaneous Tissue, Necrosis 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (50) (50) (50) (50)
Fracture 1 (2%)
Hyperostosis 1 (2%)
Skeletal Muscle (1) (1)
Hemorrhage 1 (100%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (50) (50) (50)
Meninges, Infiltration Cellular, Mononuclear
Cell 1 (2%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 4
NTP Experiment-Test: 60968-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC ISOBUTYRALDEHYDE Date: 09/23/96
Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 15:07:05
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE CONTROL 500 PPM 1000 PPM 2000 PPM
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Larynx (50) (50) (49) (50)
Inflammation, Suppurative 1 (2%)
Epiglottis, Hyperplasia 1 (2%)
Epiglottis, Metaplasia, Squamous 1 (2%)
Lung (50) (50) (50) (50)
Congestion, Chronic 1 (2%)
Hemorrhage 1 (2%) 1 (2%)
Inflammation, Suppurative 1 (2%)
Mineralization 1 (2%)
Thrombosis 1 (2%)
Alveolar Epithelium, Hyperplasia 3 (6%) 3 (6%) 1 (2%)
Alveolus, Infiltration Cellular, Histiocyte 2 (4%) 2 (4%) 1 (2%)
Bronchiole, Hyperplasia 1 (2%)
Interstitium, Fibrosis 1 (2%)
Nose (50) (50) (50) (50)
Inflammation, Suppurative 1 (2%) 1 (2%) 1 (2%)
Thrombosis 1 (2%)
Olfactory Epithelium, Degeneration 1 (2%) 1 (2%) 27 (54%) 49 (98%)
Olfactory Epithelium, Degeneration, Hyaline 1 (2%)
Olfactory Epithelium, Necrosis 2 (4%) 1 (2%)
Respiratory Epithelium, Necrosis 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (3)
Cornea, Mineralization 2 (67%)
Lens, Mineralization 1 (33%)
Harderian Gland (3) (4) (2) (2)
Hyperplasia 1 (50%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (50) (50) (50)
Amyloid Deposition 2 (4%) 1 (2%)
Atrophy 1 (2%)
Cyst 1 (2%) 1 (2%)
Infarct 1 (2%) 2 (4%) 2 (4%)
Metaplasia, Osseous 1 (2%) 4 (8%) 1 (2%)
Mineralization 1 (2%) 2 (4%)
Nephropathy 23 (46%) 20 (40%) 15 (30%) 20 (40%)
Pelvis, Dilatation 1 (2%)
Pelvis, Inflammation, Acute 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 5
NTP Experiment-Test: 60968-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC ISOBUTYRALDEHYDE Date: 09/23/96
Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 15:07:05
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE CONTROL 500 PPM 1000 PPM 2000 PPM
____________________________________________________________________________________________________________________________________
URINARY SYSTEM - CONT
Renal Tubule, Necrosis 1 (2%) 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 6
NTP Experiment-Test: 60968-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC ISOBUTYRALDEHYDE Date: 09/23/96
Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 15:07:05
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE CONTROL 500 PPM 1000 PPM 2000 PPM
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 50 50 50 50
Early Deaths
Moribund Sacrifice 6 8 6 15
Natural Death 4 5 9 5
Survivors
Terminal Sacrifice 40 37 35 30
Animals Examined Microscopically 50 50 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Gallbladder (47) (43) (42) (44)
Hyperplasia 1 (2%) 2 (5%) 2 (5%)
Intestine Large, Cecum (49) (48) (48) (48)
Fibrosis 1 (2%)
Parasite Metazoan 1 (2%)
Liver (49) (50) (50) (50)
Angiectasis 1 (2%)
Basophilic Focus 4 (8%) 8 (16%) 3 (6%) 4 (8%)
Clear Cell Focus 2 (4%) 7 (14%) 3 (6%) 2 (4%)
Cyst 1 (2%)
Degeneration, Fatty 1 (2%)
Eosinophilic Focus 3 (6%) 6 (12%) 3 (6%) 3 (6%)
Infarct, Focal 1 (2%) 2 (4%)
Mixed Cell Focus 2 (4%) 1 (2%)
Necrosis 1 (2%) 1 (2%) 1 (2%) 2 (4%)
Tension Lipidosis 1 (2%)
Centrilobular, Necrosis 1 (2%) 1 (2%)
Mesentery (1) (3) (5) (3)
Artery, Inflammation 1 (33%)
Fat, Necrosis 1 (100%) 2 (67%) 4 (80%) 2 (67%)
Pancreas (50) (49) (50) (50)
Atrophy 1 (2%) 1 (2%)
Cyst 1 (2%)
Inflammation, Chronic Active 1 (2%) 1 (2%)
Lipomatosis 2 (4%) 2 (4%) 2 (4%) 5 (10%)
Necrosis 1 (2%)
Stomach, Forestomach (50) (50) (50) (50)
Diverticulum 1 (2%)
Inflammation, Chronic Active 2 (4%) 2 (4%) 2 (4%) 1 (2%)
Stomach, Glandular (50) (50) (49) (50)
Inflammation, Chronic Active 1 (2%) 2 (4%) 1 (2%)
Artery, Inflammation 1 (2%)
Tooth (3) (2)
Developmental Malformation 3 (100%) 1 (50%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 7
NTP Experiment-Test: 60968-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC ISOBUTYRALDEHYDE Date: 09/23/96
Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 15:07:05
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE CONTROL 500 PPM 1000 PPM 2000 PPM
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (50) (50) (50) (50)
Cardiomyopathy 26 (52%) 30 (60%) 26 (52%) 27 (54%)
Inflammation, Suppurative 1 (2%)
Mineralization 1 (2%)
Atrium, Thrombosis 1 (2%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (50) (50) (50) (50)
Atrophy 1 (2%)
Hyperplasia 14 (28%) 21 (42%) 18 (36%) 18 (36%)
Hypertrophy 32 (64%) 21 (42%) 26 (52%) 26 (52%)
Adrenal Medulla (50) (50) (50) (50)
Hyperplasia 1 (2%) 1 (2%)
Pituitary Gland (49) (47) (49) (49)
Cyst 1 (2%)
Pars Distalis, Hyperplasia 3 (6%) 3 (6%)
Pars Intermedia, Hyperplasia 1 (2%) 1 (2%)
Thyroid Gland (50) (50) (50) (50)
Follicular Cell, Hyperplasia 11 (22%) 11 (22%) 14 (28%) 12 (24%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Epididymis (50) (50) (50) (50)
Granuloma Sperm 1 (2%)
Penis (1) (2)
Inflammation, Chronic Active 1 (50%)
Preputial Gland (50) (50) (49) (50)
Cyst 7 (14%) 9 (18%) 6 (12%) 4 (8%)
Inflammation, Chronic Active 1 (2%) 2 (4%) 3 (6%) 5 (10%)
Prostate (49) (50) (47) (48)
Hyperplasia 1 (2%)
Inflammation, Chronic Active 1 (2%) 1 (2%) 2 (4%)
Seminal Vesicle (50) (50) (50) (50)
Inflammation, Acute 1 (2%) 1 (2%)
Inflammation, Chronic Active 2 (4%) 1 (2%)
Testes (50) (50) (50) (50)
Degeneration 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 8
NTP Experiment-Test: 60968-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC ISOBUTYRALDEHYDE Date: 09/23/96
Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 15:07:05
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE CONTROL 500 PPM 1000 PPM 2000 PPM
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Lymph Node (4)
Iliac, Infiltration Cellular, Plasma Cell 1 (25%)
Lymph Node, Mesenteric (50) (48) (47) (47)
Angiectasis 1 (2%)
Spleen (50) (50) (50) (50)
Angiectasis 1 (2%)
Hematopoietic Cell Proliferation 7 (14%) 7 (14%) 8 (16%) 9 (18%)
Hyperplasia, Lymphoid 1 (2%) 1 (2%) 1 (2%)
Thymus (39) (39) (42) (36)
Artery, Inflammation 1 (2%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Skin (49) (50) (50) (50)
Inflammation, Chronic Active 1 (2%) 2 (4%) 2 (4%)
Necrosis 1 (2%)
Prepuce, Inflammation, Acute 3 (6%) 4 (8%) 4 (8%) 9 (18%)
Subcutaneous Tissue, Edema 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
None
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (50) (50) (50)
Cyst Epithelial Inclusion 1 (2%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Larynx (50) (49) (50) (50)
Inflammation, Suppurative 1 (2%)
Epiglottis, Hyperplasia 1 (2%) 1 (2%)
Epiglottis, Metaplasia, Squamous 1 (2%) 1 (2%) 1 (2%) 3 (6%)
Glands, Inflammation, Suppurative 1 (2%) 1 (2%) 3 (6%)
Lung (50) (50) (50) (50)
Inflammation, Suppurative 1 (2%)
Mineralization 1 (2%)
Pigmentation 1 (2%)
Alveolar Epithelium, Hyperplasia 3 (6%) 3 (6%) 3 (6%) 2 (4%)
Alveolus, Infiltration Cellular, Histiocyte 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 9
NTP Experiment-Test: 60968-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC ISOBUTYRALDEHYDE Date: 09/23/96
Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 15:07:05
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE CONTROL 500 PPM 1000 PPM 2000 PPM
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM - CONT
Artery, Mediastinum, Mineralization 1 (2%) 1 (2%)
Bronchiole, Hyperplasia 2 (4%)
Nose (50) (50) (50) (50)
Inflammation, Suppurative 2 (4%) 1 (2%) 3 (6%)
Nasolacrimal Duct, Hyperplasia 1 (2%)
Nasolacrimal Duct, Inflammation, Suppurative 1 (2%)
Olfactory Epithelium, Degeneration 11 (22%) 45 (90%)
Olfactory Epithelium, Necrosis 1 (2%)
Trachea (50) (50) (50) (50)
Inflammation, Suppurative 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (1)
Cornea, Inflammation, Chronic Active 1 (100%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (50) (50) (50)
Cyst 3 (6%) 3 (6%) 1 (2%) 1 (2%)
Infarct 2 (4%) 1 (2%) 1 (2%) 5 (10%)
Mineralization 1 (2%) 1 (2%) 1 (2%) 1 (2%)
Necrosis 1 (2%)
Nephropathy 45 (90%) 46 (92%) 44 (88%) 45 (90%)
Artery, Inflammation 2 (4%)
Pelvis, Dilatation 1 (2%)
Pelvis, Inflammation, Acute 2 (4%) 1 (2%) 2 (4%) 2 (4%)
Transitional Epithelium, Hyperplasia 1 (2%)
Urinary Bladder (50) (50) (48) (50)
Inflammation, Acute 1 (2%)
Inflammation, Chronic Active 1 (2%) 2 (4%) 3 (6%)
Mineralization 1 (2%)
Artery, Inflammation 1 (2%)
Transitional Epithelium, Hyperplasia 1 (2%) 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 10
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