NTP Experiment-Test: 60968-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC ISOBUTYRALDEHYDE Date: 08/06/96
Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 15:28:28
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 NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC ISOBUTYRALDEHYDE Date: 08/06/96
Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 15:28:28
____________________________________________________________________________________________________________________________________
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
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Esophagus (49) (50) (50) (50)
Periesophageal Tissue, Inflammation, Chronic
Active 1 (2%)
Intestine Large, Colon (48) (47) (49) (47)
Diverticulum 1 (2%)
Parasite Metazoan 3 (6%) 2 (4%) 3 (6%) 2 (4%)
Intestine Large, Rectum (48) (47) (49) (47)
Parasite Metazoan 6 (13%) 2 (4%) 3 (6%) 4 (9%)
Intestine Large, Cecum (48) (47) (49) (45)
Diverticulum 1 (2%)
Parasite Metazoan 4 (8%) 1 (2%)
Intestine Small, Ileum (47) (47) (49) (45)
Parasite Metazoan 1 (2%)
Liver (49) (50) (50) (50)
Angiectasis 1 (2%) 1 (2%)
Basophilic Focus 2 (4%) 3 (6%)
Basophilic Focus, Multiple 3 (6%)
Clear Cell Focus 4 (8%) 5 (10%) 3 (6%) 3 (6%)
Clear Cell Focus, Multiple 5 (10%) 1 (2%) 3 (6%) 2 (4%)
Eosinophilic Focus 1 (2%) 1 (2%)
Hepatodiaphragmatic Nodule 6 (12%) 6 (12%) 7 (14%) 5 (10%)
Inflammation, Granulomatous 2 (4%)
Vacuolization Cytoplasmic 5 (10%) 2 (4%) 2 (4%) 7 (14%)
Hepatocyte, Hyperplasia 1 (2%)
Hepatocyte, Necrosis 1 (2%)
Serosa, Hemorrhage 1 (2%)
Mesentery (7) (7) (8) (4)
Artery, Inflammation, Chronic 1 (14%)
Fat, Necrosis 5 (71%) 4 (57%) 6 (75%) 4 (100%)
Oral Mucosa (4) (2) (3)
Fibrosis 1 (25%)
Hyperplasia 1 (25%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 2
NTP Experiment-Test: 60968-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC ISOBUTYRALDEHYDE Date: 08/06/96
Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 15:28:28
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE CONTROL 500 PPM 1000 PPM 2000 PPM
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Inflammation, Chronic 1 (25%)
Inflammation, Suppurative 1 (50%)
Gingival, Inflammation, Suppurative 1 (50%)
Pharyngeal, Hyperplasia 2 (50%) 1 (50%) 2 (67%)
Pancreas (49) (49) (49) (50)
Atrophy 3 (6%) 2 (4%) 3 (6%)
Artery, Inflammation, Chronic 1 (2%)
Stomach, Forestomach (49) (49) (50) (50)
Hyperkeratosis 1 (2%)
Hyperplasia 5 (10%) 2 (4%) 5 (10%) 5 (10%)
Inflammation, Suppurative 1 (2%) 1 (2%)
Ulcer 1 (2%) 2 (4%) 5 (10%) 2 (4%)
Tongue (1) (1) (2)
Epithelium, Hyperplasia 1 (100%) 1 (50%)
Tooth (1) (1) (2)
Developmental Malformation 1 (100%) 1 (50%)
Inflammation, Suppurative 1 (100%) 1 (50%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (50) (50) (50) (50)
Cardiomyopathy 1 (2%) 2 (4%)
Atrium, Thrombosis 2 (4%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (49) (49) (50) (50)
Hyperplasia 1 (2%)
Vacuolization Cytoplasmic 12 (24%) 5 (10%) 9 (18%) 11 (22%)
Adrenal Medulla (49) (49) (47) (49)
Hyperplasia 4 (8%) 2 (4%)
Islets, Pancreatic (50) (48) (49) (50)
Hyperplasia 1 (2%) 1 (2%)
Pituitary Gland (48) (50) (49) (50)
Cyst 6 (13%) 14 (28%) 13 (27%) 11 (22%)
Hemorrhage 2 (4%) 2 (4%)
Pars Distalis, Hyperplasia 9 (19%) 6 (12%) 6 (12%) 5 (10%)
Pars Distalis, Hypertrophy 1 (2%)
Thyroid Gland (49) (49) (50) (50)
C-Cell, Hyperplasia 8 (16%) 7 (14%) 9 (18%) 6 (12%)
Follicular Cell, Hyperplasia 1 (2%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 3
NTP Experiment-Test: 60968-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC ISOBUTYRALDEHYDE Date: 08/06/96
Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 15:28:28
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE CONTROL 500 PPM 1000 PPM 2000 PPM
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Clitoral Gland (48) (50) (50) (48)
Cyst 7 (15%) 11 (22%) 14 (28%) 9 (19%)
Hyperplasia 2 (4%) 4 (8%) 1 (2%) 1 (2%)
Inflammation, Suppurative 2 (4%) 1 (2%) 1 (2%) 3 (6%)
Ovary (49) (50) (50) (50)
Cyst 1 (2%) 3 (6%) 2 (4%)
Uterus (48) (50) (50) (50)
Cyst 1 (2%) 1 (2%)
Cervix, Hypertrophy 1 (2%)
Endometrium, Cyst 1 (2%)
Endometrium, Hyperplasia 1 (2%) 1 (2%) 2 (4%)
Endometrium, Metaplasia, Squamous 1 (2%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Lymph Node (4) (4) (4) (5)
Renal, Pigmentation 1 (25%)
Lymph Node, Mandibular (45) (50) (46) (46)
Angiectasis 1 (2%)
Hemorrhage 1 (2%)
Hyperplasia, Lymphoid 1 (2%) 1 (2%)
Lymph Node, Mesenteric (49) (50) (50) (50)
Angiectasis 1 (2%)
Hemorrhage 1 (2%) 2 (4%)
Hyperplasia, Lymphoid 1 (2%)
Lymph Node, Mediastinal (48) (49) (50) (50)
Fibrosis 1 (2%)
Hyperplasia, Lymphoid 1 (2%)
Spleen (49) (49) (49) (50)
Accessory Spleen 4 (8%) 1 (2%) 2 (4%)
Angiectasis 1 (2%)
Fibrosis 2 (4%) 2 (4%) 1 (2%) 4 (8%)
Hematopoietic Cell Proliferation 1 (2%) 1 (2%) 1 (2%) 1 (2%)
Hemorrhage 1 (2%) 2 (4%) 2 (4%)
Thymus (48) (50) (50) (50)
Cyst 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 4
NTP Experiment-Test: 60968-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC ISOBUTYRALDEHYDE Date: 08/06/96
Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 15:28:28
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE CONTROL 500 PPM 1000 PPM 2000 PPM
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (50) (50) (50) (50)
Galactocele 1 (2%) 3 (6%) 1 (2%)
Inflammation, Chronic 1 (2%)
Epithelium, Hyperplasia 1 (2%)
Skin (49) (50) (50) (50)
Hyperkeratosis 1 (2%) 4 (8%) 1 (2%)
Hyperplasia 1 (2%)
Inflammation, Granulomatous 1 (2%)
Inflammation, Suppurative 1 (2%) 1 (2%)
Ulcer 1 (2%) 3 (6%) 1 (2%)
Epidermis, Cyst 2 (4%) 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (49) (50) (50) (50)
Hyperostosis 1 (2%)
Cranium, Fracture 1 (2%)
Cranium, Femur, Osteopetrosis 1 (2%)
Maxilla, Fracture 1 (2%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (49) (49) (50) (50)
Gliosis 1 (2%)
Hemorrhage 4 (8%) 2 (4%) 5 (10%) 1 (2%)
Necrosis 1 (2%)
Ventricle, Hydrocephalus 5 (10%) 3 (6%) 3 (6%) 2 (4%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Larynx (49) (50) (48) (50)
Foreign Body 6 (12%) 2 (4%) 7 (15%) 4 (8%)
Inflammation, Suppurative 1 (2%) 3 (6%) 6 (12%)
Epiglottis, Metaplasia, Squamous 2 (4%) 4 (8%) 6 (12%)
Epithelium, Hyperplasia 5 (10%) 1 (2%) 1 (2%)
Epithelium, Metaplasia, Squamous 5 (10%) 1 (2%) 6 (13%) 10 (20%)
Glands, Inflammation, Suppurative 5 (10%) 11 (22%) 4 (8%) 8 (16%)
Lung (49) (50) (50) (50)
Hemorrhage 3 (6%) 4 (8%) 4 (8%)
Inflammation, Granulomatous 1 (2%)
Alveolar Epithelium, Fibrosis 4 (8%) 2 (4%) 2 (4%) 2 (4%)
Alveolar Epithelium, Foreign Body 1 (2%)
Alveolar Epithelium, Hyperplasia 1 (2%) 6 (12%) 3 (6%) 3 (6%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 5
NTP Experiment-Test: 60968-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC ISOBUTYRALDEHYDE Date: 08/06/96
Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 15:28:28
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE CONTROL 500 PPM 1000 PPM 2000 PPM
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM - CONT
Alveolar Epithelium, Infiltration Cellular,
Histiocyte 10 (20%) 10 (20%) 11 (22%) 7 (14%)
Bronchiole, Hyperplasia 1 (2%)
Nose (49) (50) (49) (50)
Cyst 2 (4%) 5 (10%)
Foreign Body 2 (4%) 2 (4%) 5 (10%) 5 (10%)
Hemorrhage 1 (2%)
Inflammation, Suppurative 2 (4%) 3 (6%) 5 (10%) 11 (22%)
Nasolacrimal Duct, Inflammation, Suppurative 1 (2%) 1 (2%)
Nasolacrimal Duct, Metaplasia, Squamous 1 (2%) 1 (2%)
Olfactory Epithelium, Degeneration 2 (4%) 45 (90%)
Respiratory Epithelium, Hyperplasia 1 (2%) 1 (2%) 1 (2%)
Respiratory Epithelium, Metaplasia, Squamous 1 (2%) 11 (22%) 9 (18%) 44 (88%)
Pleura (1) (1)
Inflammation 1 (100%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (3) (2) (1) (1)
Cornea, Mineralization 1 (50%)
Lens, Cataract 2 (67%) 1 (50%) 1 (100%) 1 (100%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (49) (49) (50) (50)
Nephropathy, Chronic 35 (71%) 30 (61%) 30 (60%) 36 (72%)
Cortex, Necrosis 1 (2%)
Medulla, Renal Tubule, Cyst 1 (2%)
Pelvis, Dilatation 1 (2%) 1 (2%)
Renal Tubule, Degeneration 1 (2%)
Renal Tubule, Inflammation, Suppurative 1 (2%) 1 (2%)
Renal Tubule, Mineralization 5 (10%) 2 (4%) 5 (10%) 2 (4%)
Urinary Bladder (49) (49) (50) (50)
Hemorrhage 1 (2%) 1 (2%)
Transitional Epithelium, Hyperplasia 2 (4%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 6
NTP Experiment-Test: 60968-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC ISOBUTYRALDEHYDE Date: 08/06/96
Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 15:28:28
____________________________________________________________________________________________________________________________________
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)
Inflammation, Suppurative 1 (2%)
Parasite Metazoan 1 (2%) 2 (4%) 3 (6%) 4 (8%)
Ulcer 1 (2%)
Intestine Large, Rectum (50) (47) (49) (50)
Parasite Metazoan 4 (8%) 3 (6%) 3 (6%) 2 (4%)
Intestine Large, Cecum (47) (49) (48) (48)
Edema 1 (2%)
Parasite Metazoan 2 (4%) 1 (2%) 3 (6%) 8 (17%)
Intestine Small, Ileum (48) (49) (48) (47)
Diverticulum 1 (2%)
Epithelium, Hyperplasia 1 (2%)
Liver (50) (49) (50) (50)
Angiectasis 2 (4%) 6 (12%) 4 (8%)
Basophilic Focus 2 (4%) 1 (2%)
Clear Cell Focus 3 (6%) 2 (4%) 1 (2%)
Eosinophilic Focus 1 (2%)
Hemorrhage 1 (2%)
Hepatodiaphragmatic Nodule 5 (10%) 4 (8%) 5 (10%) 5 (10%)
Hyperplasia, Reticulum Cell 1 (2%)
Inflammation, Granulomatous 2 (4%)
Mixed Cell Focus 1 (2%)
Thrombosis 1 (2%)
Vacuolization Cytoplasmic 10 (20%) 6 (12%) 6 (12%) 8 (16%)
Bile Duct, Hyperplasia 4 (8%) 2 (4%) 3 (6%) 3 (6%)
Hepatocyte, Degeneration, Cystic 2 (4%) 5 (10%) 5 (10%) 4 (8%)
Hepatocyte, Hyperplasia 1 (2%) 2 (4%) 2 (4%) 2 (4%)
Hepatocyte, Necrosis 2 (4%) 2 (4%) 4 (8%) 3 (6%)
Serosa, Fibrosis 1 (2%)
Mesentery (11) (12) (8) (10)
Fat, Hemorrhage 1 (8%)
Fat, Inflammation, Granulomatous 1 (9%) 1 (8%) 1 (10%)
Fat, Necrosis 10 (91%) 10 (83%) 7 (88%) 7 (70%)
Oral Mucosa (3) (2) (2)
a Number of animals examined microscopically at site and number of animals with lesion
Page 7
NTP Experiment-Test: 60968-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC ISOBUTYRALDEHYDE Date: 08/06/96
Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 15:28:28
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE CONTROL 500 PPM 1000 PPM 2000 PPM
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Cyst 1 (33%)
Hyperplasia 1 (50%)
Gingival, Hyperplasia 1 (50%)
Pharyngeal, Hyperplasia 1 (33%) 1 (50%)
Pancreas (50) (48) (50) (50)
Atrophy 9 (18%) 8 (17%) 11 (22%) 7 (14%)
Stomach, Forestomach (50) (49) (50) (50)
Edema 3 (6%) 2 (4%)
Hyperkeratosis 3 (6%)
Hyperplasia 5 (10%) 9 (18%) 15 (30%) 7 (14%)
Inflammation, Suppurative 1 (2%) 2 (4%) 1 (2%)
Necrosis 1 (2%)
Ulcer 4 (8%) 5 (10%) 9 (18%) 4 (8%)
Stomach, Glandular (50) (49) (50) (50)
Inflammation, Suppurative 1 (2%)
Mineralization 1 (2%)
Necrosis 2 (4%) 1 (2%)
Thrombosis 1 (2%)
Ulcer 1 (2%) 1 (2%)
Tooth (1) (1)
Developmental Malformation 1 (100%)
Inflammation, Suppurative 1 (100%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Blood Vessel (41) (48) (50) (38)
Mineralization 1 (3%)
Heart (50) (49) (50) (50)
Cardiomyopathy 6 (12%) 1 (2%) 3 (6%) 8 (16%)
Mineralization 1 (2%)
Atrium, Thrombosis 2 (4%) 2 (4%) 4 (8%) 3 (6%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (50) (49) (50) (50)
Hemorrhage 1 (2%) 1 (2%)
Hyperplasia 1 (2%)
Vacuolization Cytoplasmic 3 (6%) 6 (12%) 6 (12%) 3 (6%)
Adrenal Medulla (49) (49) (50) (50)
Hyperplasia 20 (41%) 16 (33%) 12 (24%) 14 (28%)
Islets, Pancreatic (50) (49) (50) (50)
Hyperplasia 2 (4%) 3 (6%) 1 (2%) 1 (2%)
Parathyroid Gland (48) (48) (49) (48)
Hyperplasia 1 (2%) 1 (2%) 3 (6%)
Pituitary Gland (50) (49) (49) (50)
a Number of animals examined microscopically at site and number of animals with lesion
Page 8
NTP Experiment-Test: 60968-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC ISOBUTYRALDEHYDE Date: 08/06/96
Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 15:28:28
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE CONTROL 500 PPM 1000 PPM 2000 PPM
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM - CONT
Cyst 3 (6%) 2 (4%) 2 (4%) 7 (14%)
Hemorrhage 2 (4%) 4 (8%) 3 (6%)
Pars Distalis, Hyperplasia 4 (8%) 9 (18%) 5 (10%) 6 (12%)
Pars Distalis, Hypertrophy 1 (2%)
Thyroid Gland (50) (49) (50) (50)
C-Cell, Hyperplasia 3 (6%) 5 (10%) 8 (16%) 5 (10%)
Follicular Cell, Hyperplasia 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Epididymis (50) (49) (50) (50)
Inflammation, Granulomatous 2 (4%) 1 (2%)
Inflammation, Suppurative 1 (2%)
Epithelium, Hyperplasia 1 (2%)
Penis (1)
Hemorrhage 1 (100%)
Thrombosis, Acute 1 (100%)
Preputial Gland (50) (49) (50) (50)
Cyst 3 (6%) 10 (20%) 11 (22%) 1 (2%)
Hyperplasia 4 (8%) 1 (2%) 2 (4%) 2 (4%)
Inflammation, Chronic 1 (2%) 1 (2%)
Inflammation, Suppurative 9 (18%) 3 (6%) 8 (16%) 10 (20%)
Prostate (50) (49) (50) (50)
Inflammation, Suppurative 4 (8%) 4 (8%) 4 (8%) 2 (4%)
Epithelium, Hyperplasia 2 (4%) 3 (6%) 2 (4%) 3 (6%)
Seminal Vesicle (50) (49) (50) (50)
Inflammation, Suppurative 1 (2%)
Epithelium, Hyperplasia 1 (2%) 1 (2%)
Testes (50) (50) (50) (50)
Necrosis 1 (2%)
Artery, Inflammation 3 (6%) 1 (2%) 1 (2%)
Germinal Epithelium, Atrophy 7 (14%) 6 (12%) 8 (16%) 8 (16%)
Interstitial Cell, Hyperplasia 7 (14%) 1 (2%) 5 (10%) 8 (16%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (50) (49) (50) (50)
Hyperplasia, Reticulum Cell 1 (2%)
Myelofibrosis 2 (4%)
Lymph Node (15) (10) (6) (7)
a Number of animals examined microscopically at site and number of animals with lesion
Page 9
NTP Experiment-Test: 60968-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC ISOBUTYRALDEHYDE Date: 08/06/96
Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 15:28:28
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE CONTROL 500 PPM 1000 PPM 2000 PPM
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - CONT
Iliac, Ectasia 1 (10%)
Lymph Node, Bronchial (50) (46) (49) (50)
Fibrosis 1 (2%)
Lymph Node, Mandibular (46) (46) (44) (44)
Fibrosis 1 (2%)
Hyperplasia, Lymphoid 1 (2%) 1 (2%) 1 (2%)
Lymph Node, Mesenteric (50) (49) (50) (50)
Ectasia 1 (2%)
Fibrosis 1 (2%)
Hyperplasia, Lymphoid 1 (2%)
Lymph Node, Mediastinal (49) (49) (50) (50)
Fibrosis 1 (2%) 2 (4%)
Hemorrhage 1 (2%) 1 (2%)
Hyperplasia, Histiocytic 1 (2%)
Spleen (50) (49) (50) (50)
Accessory Spleen 1 (2%) 1 (2%) 1 (2%)
Angiectasis 1 (2%)
Fibrosis 10 (20%) 18 (37%) 9 (18%) 17 (34%)
Hematopoietic Cell Proliferation 1 (2%)
Hemorrhage 3 (6%) 1 (2%) 1 (2%) 2 (4%)
Necrosis 1 (2%) 2 (4%) 1 (2%)
Thymus (50) (49) (50) (49)
Ectopic Parathyroid Gland 1 (2%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (50) (49) (50) (50)
Galactocele 5 (10%) 1 (2%) 3 (6%)
Epithelium, Hyperplasia 1 (2%) 1 (2%)
Skin (50) (50) (50) (50)
Acanthosis 1 (2%)
Hyperkeratosis 2 (4%) 13 (26%) 2 (4%)
Hyperplasia 5 (10%)
Inflammation, Granulomatous 2 (4%) 4 (8%)
Inflammation, Suppurative 3 (6%) 2 (4%)
Ulcer 1 (2%) 1 (2%) 3 (6%) 5 (10%)
Epidermis, Cyst 4 (8%) 1 (2%) 1 (2%) 3 (6%)
Sebaceous Gland, Cyst 1 (2%)
Sebaceous Gland, Hyperplasia 1 (2%)
Subcutaneous Tissue, Edema 1 (2%)
Subcutaneous Tissue, Hemorrhage 1 (2%)
Subcutaneous Tissue, Epidermis, Cyst 1 (2%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 10
NTP Experiment-Test: 60968-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC ISOBUTYRALDEHYDE Date: 08/06/96
Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 15:28:28
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE CONTROL 500 PPM 1000 PPM 2000 PPM
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (50) (48) (50) (50)
Cranium, Fibrosis 1 (2%)
Cranium, Inflammation, Granulomatous 2 (4%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (50) (50) (50)
Gliosis 1 (2%)
Hemorrhage 4 (8%) 9 (18%) 6 (12%) 4 (8%)
Ventricle, Hydrocephalus 3 (6%) 1 (2%) 8 (16%) 5 (10%)
Spinal Cord (1) (1) (1)
Hemorrhage 1 (100%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Larynx (50) (49) (49) (50)
Foreign Body 3 (6%) 4 (8%) 3 (6%) 5 (10%)
Inflammation, Suppurative 1 (2%) 2 (4%)
Epiglottis, Metaplasia, Squamous 1 (2%)
Epithelium, Hyperplasia 1 (2%) 1 (2%) 1 (2%) 1 (2%)
Epithelium, Metaplasia, Squamous 1 (2%) 3 (6%) 1 (2%) 4 (8%)
Glands, Inflammation, Suppurative 4 (8%) 6 (12%) 6 (12%) 3 (6%)
Lung (50) (49) (50) (50)
Hemorrhage 7 (14%) 3 (6%) 8 (16%) 6 (12%)
Inflammation, Granulomatous 1 (2%)
Alveolar Epithelium, Fibrosis 5 (10%)
Alveolar Epithelium, Foreign Body 1 (2%) 1 (2%)
Alveolar Epithelium, Hyperplasia 5 (10%) 9 (18%) 4 (8%) 5 (10%)
Alveolar Epithelium, Infiltration Cellular,
Histiocyte 2 (4%) 10 (20%) 8 (16%) 6 (12%)
Alveolar Epithelium, Pigmentation 1 (2%)
Bronchiole, Bronchus, Interstitium, Fibrosis 1 (2%)
Interstitium, Mineralization 1 (2%)
Nose (50) (49) (49) (50)
Cyst 5 (10%) 3 (6%) 7 (14%) 7 (14%)
Foreign Body 5 (10%) 5 (10%) 4 (8%) 7 (14%)
Inflammation, Suppurative 5 (10%) 3 (6%) 6 (12%) 15 (30%)
Nasopharyngeal Duct, Hyperplasia 1 (2%)
Nasopharyngeal Duct, Inflammation,
Suppurative 1 (2%)
Nasopharyngeal Duct, Metaplasia, Squamous 2 (4%)
Olfactory Epithelium, Degeneration 3 (6%) 44 (88%)
Respiratory Epithelium, Hyperplasia 2 (4%) 3 (6%) 5 (10%)
Respiratory Epithelium, Metaplasia, Squamous 1 (2%) 1 (2%) 10 (20%) 44 (88%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 11
NTP Experiment-Test: 60968-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC ISOBUTYRALDEHYDE Date: 08/06/96
Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 15:28:28
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE CONTROL 500 PPM 1000 PPM 2000 PPM
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM - CONT
Vomeronasal Organ, Dilatation 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (4) (1) (5) (3)
Cataract 3 (75%) 2 (40%) 3 (100%)
Cornea, Mineralization 1 (25%)
Cornea, Lens, Mineralization 1 (33%)
Lens, Cataract 1 (100%) 1 (20%)
Lens, Mineralization 1 (25%)
Harderian Gland (1)
Hyperplasia 1 (100%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (49) (50) (50)
Nephropathy, Chronic 47 (94%) 48 (98%) 48 (96%) 49 (98%)
Artery, Inflammation 1 (2%)
Artery, Necrosis, Fibrinoid 1 (2%)
Cortex, Cyst 1 (2%)
Cortex, Necrosis 1 (2%) 2 (4%)
Pelvis, Transitional Epithelium, Hyperplasia 1 (2%)
Renal Tubule, Hyperplasia 1 (2%) 2 (4%)
Renal Tubule, Hyperplasia, Atypical 1 (2%)
Renal Tubule, Mineralization 1 (2%)
Urinary Bladder (50) (48) (50) (50)
Calculus Micro Observation Only 1 (2%) 1 (2%) 1 (2%)
Hemorrhage 2 (4%) 1 (2%)
Inflammation, Suppurative 1 (2%) 1 (2%)
Ulcer 1 (2%)
Transitional Epithelium, Hyperplasia 4 (8%) 2 (4%)
a Number of animals examined microscopically at site and number of animals with lesion
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