TDMS Study 60968-01 Pathology Tables
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 Page 12 ------------------------------------------------------------ ---------- END OF REPORT ---------- ------------------------------------------------------------