TDMS Study 97006-01 Pathology Tables
NTP Experiment-Test: 97006-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC METHYL ISOBUTYL KETONE Date: 05/11/04 Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 08:44:57 FINAL#1/RATS Facility: Battelle Northwest Chemical CAS #: 108-10-1 Lock Date: 01/24/03 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: 97006-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC METHYL ISOBUTYL KETONE Date: 05/11/04 Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 08:44:57 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE CONTROL 450 PPM 900 PPM 1800 PPM ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 50 50 50 50 Early Deaths Moribund Sacrifice 14 14 20 15 Natural Death 1 2 4 3 Survivors Moribund Sacrifice 1 Terminal Sacrifice 35 33 26 32 Animals Examined Microscopically 50 50 50 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Colon (50) (49) (49) (50) Foreign Body 1 (2%) Intestine Small, Duodenum (50) (50) (49) (50) Foreign Body 1 (2%) Intestine Small, Jejunum (50) (49) (49) (49) Necrosis 1 (2%) Liver (50) (50) (50) (50) Angiectasis 1 (2%) Basophilic Focus 36 (72%) 24 (48%) 26 (52%) 20 (40%) Clear Cell Focus 11 (22%) 10 (20%) 11 (22%) 7 (14%) Eosinophilic Focus 3 (6%) 1 (2%) 2 (4%) Hepatodiaphragmatic Nodule 8 (16%) 12 (24%) 9 (18%) 5 (10%) Inflammation, Granulomatous 1 (2%) Mixed Cell Focus 1 (2%) 3 (6%) Necrosis 2 (4%) 3 (6%) Vacuolization Cytoplasmic 3 (6%) 3 (6%) 5 (10%) 4 (8%) Hepatocyte, Regeneration 1 (2%) 1 (2%) 2 (4%) 2 (4%) Serosa, Fibrosis 1 (2%) Mesentery (18) (17) (15) (15) Fibrosis 1 (6%) Hemorrhage 1 (6%) Inflammation, Granulomatous 1 (7%) Necrosis 18 (100%) 15 (88%) 15 (100%) 14 (93%) Pancreas (50) (50) (50) (50) Cyst 1 (2%) Acinus, Atrophy 1 (2%) 1 (2%) 1 (2%) Stomach, Forestomach (50) (50) (50) (50) Hyperkeratosis 1 (2%) Hyperplasia, Squamous 2 (4%) 2 (4%) a Number of animals examined microscopically at site and number of animals with lesion Page 2 NTP Experiment-Test: 97006-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC METHYL ISOBUTYL KETONE Date: 05/11/04 Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 08:44:57 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE CONTROL 450 PPM 900 PPM 1800 PPM ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Necrosis 1 (2%) Ulcer 2 (4%) 1 (2%) 1 (2%) Tongue (1) (1) (3) (2) Epithelium, Hyperplasia 1 (100%) 1 (100%) 3 (100%) 2 (100%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (50) (50) (50) (50) Cardiomyopathy 1 (2%) 1 (2%) 3 (6%) 2 (4%) Atrium, Thrombosis 1 (2%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (50) (50) (50) (50) Hyperplasia 1 (2%) 1 (2%) Vacuolization Cytoplasmic 9 (18%) 4 (8%) 13 (26%) 9 (18%) Adrenal Medulla (50) (50) (50) (50) Atrophy 1 (2%) Hyperplasia 2 (4%) Necrosis 1 (2%) Islets, Pancreatic (50) (50) (50) (50) Hyperplasia 1 (2%) 1 (2%) 1 (2%) Pituitary Gland (49) (50) (50) (50) Cyst 3 (6%) 6 (12%) 4 (8%) 3 (6%) Hemorrhage 2 (4%) 2 (4%) 3 (6%) Hyperplasia 11 (22%) 11 (22%) 8 (16%) 10 (20%) Thyroid Gland (50) (50) (50) (50) Cyst 1 (2%) C-Cell, Hyperplasia 4 (8%) 2 (4%) 2 (4%) 5 (10%) Follicular Cell, Hyperplasia 1 (2%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Clitoral Gland (50) (50) (50) (50) Cyst 2 (4%) 3 (6%) 1 (2%) 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 3 NTP Experiment-Test: 97006-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC METHYL ISOBUTYL KETONE Date: 05/11/04 Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 08:44:57 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE CONTROL 450 PPM 900 PPM 1800 PPM ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM - CONT Hyperplasia 1 (2%) 3 (6%) 1 (2%) 1 (2%) Inflammation, Chronic 1 (2%) 1 (2%) Ovary (50) (50) (50) (50) Cyst 6 (12%) 10 (20%) 7 (14%) 4 (8%) Cyst, Multiple 1 (2%) Uterus (50) (50) (50) (50) Cyst 1 (2%) Decidual Reaction 1 (2%) Hemorrhage 1 (2%) 1 (2%) 2 (4%) Necrosis 2 (4%) 1 (2%) Thrombosis 1 (2%) Endometrium, Hyperplasia 1 (2%) 2 (4%) 3 (6%) 3 (6%) Endometrium, Inflammation, Suppurative 1 (2%) Myometrium, Hyperplasia 1 (2%) Vagina (2) (1) Muscularis, Hyperplasia 1 (100%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (50) (50) (50) (50) Myelofibrosis 1 (2%) Lymph Node (1) (2) (2) (3) Pancreatic, Hemorrhage 1 (50%) Lymph Node, Bronchial (9) (12) (8) (7) Ectasia 2 (22%) Hemorrhage 1 (8%) Hyperplasia, Lymphoid 2 (17%) Pigmentation 1 (11%) 2 (17%) Lymph Node, Mediastinal (46) (44) (46) (49) Angiectasis 1 (2%) Spleen (50) (50) (50) (50) Accessory Spleen 1 (2%) 1 (2%) Fibrosis 1 (2%) Hemorrhage 1 (2%) 1 (2%) Inflammation, Granulomatous 1 (2%) Necrosis 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (50) (50) (50) (50) Galactocele 1 (2%) 1 (2%) 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 4 NTP Experiment-Test: 97006-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC METHYL ISOBUTYL KETONE Date: 05/11/04 Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 08:44:57 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE CONTROL 450 PPM 900 PPM 1800 PPM ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM - CONT Epithelium, Hyperplasia 1 (2%) Skin (50) (50) (50) (50) Cyst Epithelial Inclusion 1 (2%) 1 (2%) 1 (2%) Hyperkeratosis 1 (2%) Hyperplasia, Focal, Squamous 1 (2%) Inflammation, Acute 2 (4%) Ulcer 1 (2%) 1 (2%) 2 (4%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM None ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (50) (50) (50) Compression 8 (16%) 11 (22%) 10 (20%) 7 (14%) Gliosis 1 (2%) Hemorrhage 5 (10%) 4 (8%) 10 (20%) 5 (10%) Necrosis 1 (2%) 2 (4%) Thrombosis 1 (2%) Cerebrum, Pigmentation 1 (2%) Spinal Cord (10) (4) (6) (14) Cyst Epithelial Inclusion 1 (7%) Hemorrhage 1 (7%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Larynx (50) (50) (50) (50) Foreign Body 1 (2%) 2 (4%) 3 (6%) 2 (4%) Inflammation, Chronic 1 (2%) 1 (2%) Inflammation, Suppurative 1 (2%) 2 (4%) Epiglottis, Hyperplasia 1 (2%) Epiglottis, Metaplasia, Squamous 1 (2%) 2 (4%) 2 (4%) Lung (50) (50) (50) (50) Foreign Body 1 (2%) Hemorrhage 1 (2%) Inflammation, Chronic 2 (4%) 10 (20%) 7 (14%) 4 (8%) Inflammation, Granulomatous 1 (2%) Alveolar Epithelium, Hyperplasia 3 (6%) 5 (10%) 2 (4%) 6 (12%) Alveolar Epithelium, Metaplasia, Squamous 1 (2%) 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 5 NTP Experiment-Test: 97006-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC METHYL ISOBUTYL KETONE Date: 05/11/04 Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 08:44:57 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE CONTROL 450 PPM 900 PPM 1800 PPM ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM - CONT Alveolus, Emphysema 1 (2%) Alveolus, Infiltration Cellular, Histiocyte 13 (26%) 2 (4%) 5 (10%) 11 (22%) Alveolus, Pigmentation 1 (2%) Bronchiole, Hyperplasia 1 (2%) 2 (4%) 2 (4%) 3 (6%) Interstitium, Fibrosis 2 (4%) 2 (4%) 2 (4%) 1 (2%) Nose (50) (50) (50) (50) Foreign Body 2 (4%) 2 (4%) 1 (2%) Inflammation, Suppurative 1 (2%) 6 (12%) Goblet Cell, Hyperplasia 2 (4%) 1 (2%) Nasolacrimal Duct, Inflammation, Suppurative 5 (10%) 2 (4%) 2 (4%) Olfactory Epithelium, Degeneration, Hyaline 1 (2%) 1 (2%) 2 (4%) Respiratory Epithelium, Degeneration, Hyaline 9 (18%) 3 (6%) 8 (16%) 9 (18%) Respiratory Epithelium, Hyperplasia 2 (4%) 2 (4%) Pleura (50) (50) (50) (50) Fibrosis 12 (24%) 7 (14%) 4 (8%) 5 (10%) Inflammation, Chronic 7 (14%) 7 (14%) 1 (2%) 1 (2%) Mesothelium, Hyperplasia 1 (2%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (49) (50) (48) (49) Inflammation, Suppurative 1 (2%) 2 (4%) Cornea, Inflammation, Suppurative 1 (2%) Lens, Cataract 2 (4%) 3 (6%) 4 (8%) 4 (8%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (50) (50) (50) Infarct 1 (2%) Nephropathy 19 (38%) 35 (70%) 38 (76%) 44 (88%) Papilla, Mineralization 3 (6%) 5 (10%) 3 (6%) 3 (6%) Pelvis, Transitional Epithelium, Hyperplasia 1 (2%) 1 (2%) 1 (2%) Pelvis, Transitional Epithelium, Mineralization 9 (18%) 6 (12%) 7 (14%) 2 (4%) Renal Tubule, Cyst 1 (2%) 1 (2%) Renal Tubule, Hyperplasia 1 (2%) 1 (2%) 1 (2%) Urinary Bladder (50) (50) (50) (50) Hemorrhage 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 6 NTP Experiment-Test: 97006-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC METHYL ISOBUTYL KETONE Date: 05/11/04 Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 08:44:57 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE CONTROL 450 PPM 900 PPM 1800 PPM ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 50 50 50 50 Early Deaths Moribund Sacrifice 14 16 21 29 Natural Death 4 5 4 2 Accidently Killed 1 Survivors Terminal Sacrifice 32 28 25 19 Animals Examined Microscopically 50 50 50 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Cecum (48) (48) (50) (50) Ulcer 1 (2%) 2 (4%) Intestine Small, Ileum (48) (47) (48) (49) Diverticulum 1 (2%) Liver (50) (50) (50) (50) Angiectasis 1 (2%) 1 (2%) Basophilic Focus 11 (22%) 5 (10%) 13 (26%) 4 (8%) Clear Cell Focus 14 (28%) 13 (26%) 17 (34%) 9 (18%) Degeneration, Cystic 1 (2%) 1 (2%) 3 (6%) Eosinophilic Focus 2 (4%) 6 (12%) 10 (20%) 9 (18%) Hemorrhage 1 (2%) Hepatodiaphragmatic Nodule 3 (6%) 6 (12%) 7 (14%) 7 (14%) Inflammation, Granulomatous 1 (2%) Mixed Cell Focus 1 (2%) 2 (4%) 1 (2%) Necrosis 1 (2%) 6 (12%) 1 (2%) Vacuolization Cytoplasmic 4 (8%) 2 (4%) 2 (4%) Bile Duct, Cyst 1 (2%) Bile Duct, Hyperplasia 3 (6%) 4 (8%) 4 (8%) Bile Duct, Inflammation, Suppurative 1 (2%) Centrilobular, Necrosis 1 (2%) 1 (2%) 1 (2%) 4 (8%) Hepatocyte, Regeneration 2 (4%) 1 (2%) 4 (8%) Periportal, Inflammation, Chronic 1 (2%) Mesentery (10) (12) (9) (7) Necrosis 10 (100%) 12 (100%) 9 (100%) 7 (100%) Oral Mucosa (2) Pharyngeal, Hyperplasia, Squamous 1 (50%) Pancreas (50) (48) (50) (50) Hemorrhage 1 (2%) Necrosis 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 7 NTP Experiment-Test: 97006-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC METHYL ISOBUTYL KETONE Date: 05/11/04 Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 08:44:57 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE CONTROL 450 PPM 900 PPM 1800 PPM ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Acinus, Atrophy 4 (8%) 7 (15%) 5 (10%) 2 (4%) Artery, Thrombosis 1 (2%) Salivary Glands (50) (48) (50) (50) Hyperplasia 1 (2%) Stomach, Forestomach (50) (48) (50) (50) Hyperplasia, Squamous 1 (2%) 1 (2%) Ulcer 3 (6%) 1 (2%) 6 (12%) 6 (12%) Stomach, Glandular (50) (48) (50) (50) Erosion 1 (2%) 1 (2%) 2 (4%) 3 (6%) Ulcer 1 (2%) Serosa, Fibrosis 1 (2%) Tongue (1) (1) Epithelium, Hyperplasia 1 (100%) 1 (100%) Tooth (1) Peridontal Tissue, Inflammation 1 (100%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (50) (49) (50) (50) Cardiomyopathy 14 (28%) 9 (18%) 12 (24%) 8 (16%) Atrium, Thrombosis 2 (4%) 4 (8%) 3 (6%) 1 (2%) Myocardium, Mineralization 1 (2%) Pericardium, Fibrosis 1 (2%) Pericardium, Inflammation, Chronic 1 (2%) Valve, Inflammation, Suppurative 1 (2%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (50) (48) (50) (50) Atrophy 1 (2%) 1 (2%) Hyperplasia 1 (2%) Necrosis 1 (2%) Vacuolization Cytoplasmic 7 (14%) 3 (6%) 6 (12%) 3 (6%) Adrenal Medulla (50) (48) (50) (50) Atrophy 1 (2%) Hemorrhage 1 (2%) Hyperplasia 13 (26%) 18 (38%) 18 (36%) 24 (48%) Thrombosis 1 (2%) Islets, Pancreatic (50) (48) (50) (50) Hyperplasia 1 (2%) 1 (2%) Parathyroid Gland (49) (48) (49) (50) a Number of animals examined microscopically at site and number of animals with lesion Page 8 NTP Experiment-Test: 97006-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC METHYL ISOBUTYL KETONE Date: 05/11/04 Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 08:44:57 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE CONTROL 450 PPM 900 PPM 1800 PPM ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM - CONT Hyperplasia 1 (2%) Pituitary Gland (50) (49) (50) (50) Angiectasis 1 (2%) Atrophy 1 (2%) Cyst 1 (2%) 1 (2%) 1 (2%) Hemorrhage 4 (8%) 1 (2%) 1 (2%) Hyperplasia 8 (16%) 8 (16%) 9 (18%) 9 (18%) Thyroid Gland (50) (48) (50) (50) C-Cell, Hyperplasia 4 (8%) 3 (6%) 5 (10%) 1 (2%) Follicle, Cyst 1 (2%) 1 (2%) 1 (2%) Follicular Cell, Hyperplasia 1 (2%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Preputial Gland (50) (49) (50) (50) Cyst 1 (2%) 2 (4%) Hyperplasia 1 (2%) 2 (4%) 3 (6%) Inflammation, Granulomatous 1 (2%) Inflammation, Suppurative 1 (2%) Prostate (50) (49) (50) (50) Inflammation, Suppurative 3 (6%) 1 (2%) 2 (4%) Seminal Vesicle (50) (49) (50) (50) Hyperplasia 1 (2%) Testes (50) (50) (50) (50) Germinal Epithelium, Atrophy 10 (20%) 8 (16%) 8 (16%) 15 (30%) Interstitial Cell, Hyperplasia 4 (8%) 3 (6%) 1 (2%) 3 (6%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (50) (49) (50) (50) Hyperplasia, Reticulum Cell 1 (2%) Myelofibrosis 1 (2%) Lymph Node (7) (7) (12) (15) Infiltration Cellular, Histiocyte 1 (8%) Deep Cervical, Hemorrhage 1 (14%) Deep Cervical, Infiltration Cellular, a Number of animals examined microscopically at site and number of animals with lesion Page 9 NTP Experiment-Test: 97006-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC METHYL ISOBUTYL KETONE Date: 05/11/04 Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 08:44:57 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE CONTROL 450 PPM 900 PPM 1800 PPM ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - CONT Histiocyte 1 (14%) Deep Cervical, Pigmentation 1 (7%) Pancreatic, Ectasia 2 (29%) Pancreatic, Pigmentation 1 (8%) Renal, Ectasia 1 (8%) Lymph Node, Bronchial (11) (13) (12) (7) Angiectasis 1 (9%) Ectasia 3 (27%) 2 (15%) 1 (8%) Hemorrhage 1 (8%) Infiltration Cellular, Histiocyte 1 (9%) 1 (8%) Pigmentation 1 (9%) 1 (8%) Lymph Node, Mesenteric (50) (48) (50) (50) Hyperplasia, Lymphoid 1 (2%) 1 (2%) Lymph Node, Mediastinal (41) (44) (46) (44) Angiectasis 1 (2%) Hemorrhage 1 (2%) Hyperplasia, Lymphoid 1 (2%) 1 (2%) Infiltration Cellular, Histiocyte 1 (2%) Pigmentation 1 (2%) 1 (2%) Spleen (50) (50) (50) (50) Accessory Spleen 2 (4%) 1 (2%) 1 (2%) Fibrosis 2 (4%) 5 (10%) 3 (6%) 8 (16%) Hemorrhage 2 (4%) 2 (4%) 2 (4%) 1 (2%) Necrosis 4 (8%) 4 (8%) 6 (12%) 4 (8%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (49) (49) (50) (50) Galactocele 5 (10%) 1 (2%) 3 (6%) Skin (50) (49) (50) (50) Cyst Epithelial Inclusion 3 (6%) 3 (6%) 4 (8%) Hyperkeratosis 1 (2%) 1 (2%) 1 (2%) 3 (6%) Hyperplasia, Focal, Squamous 1 (2%) Inflammation, Acute 1 (2%) Inflammation, Granulomatous 1 (2%) 2 (4%) Sebaceous Gland, Hyperplasia 1 (2%) Subcutaneous Tissue, Fibrosis 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (50) (50) (50) (50) a Number of animals examined microscopically at site and number of animals with lesion Page 10 NTP Experiment-Test: 97006-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC METHYL ISOBUTYL KETONE Date: 05/11/04 Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 08:44:57 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE CONTROL 450 PPM 900 PPM 1800 PPM ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM - CONT Hyperostosis 1 (2%) Cranium, Maxilla, Fracture 1 (2%) Tibia, Fracture 1 (2%) Skeletal Muscle (3) (3) (4) (6) Hemorrhage 1 (17%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (49) (50) (50) Compression 8 (16%) 8 (16%) 3 (6%) 6 (12%) Hemorrhage 5 (10%) 3 (6%) 6 (12%) 4 (8%) Spinal Cord (2) (3) (5) (5) Gliosis 1 (20%) Inflammation 1 (20%) Neuron, Degeneration 1 (20%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Larynx (50) (48) (50) (50) Foreign Body 2 (4%) 3 (6%) 6 (12%) 4 (8%) Inflammation, Suppurative 2 (4%) 2 (4%) 2 (4%) Epiglottis, Hyperplasia 1 (2%) Epiglottis, Metaplasia, Squamous 1 (2%) Lung (50) (49) (50) (50) Hemorrhage 2 (4%) 5 (10%) 5 (10%) Inflammation, Chronic 4 (8%) 2 (4%) Inflammation, Suppurative 2 (4%) 1 (2%) Thrombosis 1 (2%) Alveolar Epithelium, Hyperplasia 4 (8%) 7 (14%) 4 (8%) 4 (8%) Alveolar Epithelium, Metaplasia, Squamous 1 (2%) Alveolus, Emphysema 2 (4%) Alveolus, Infiltration Cellular, Histiocyte 10 (20%) 5 (10%) 6 (12%) 6 (12%) Alveolus, Pigmentation 1 (2%) Bronchiole, Hyperplasia 1 (2%) Bronchiole, Alveolus, Foreign Body 1 (2%) Interstitium, Fibrosis 2 (4%) 3 (6%) 1 (2%) Nose (50) (49) (50) (50) Foreign Body 1 (2%) 3 (6%) 4 (8%) 7 (14%) Inflammation, Suppurative 4 (8%) 8 (16%) 4 (8%) 10 (20%) Goblet Cell, Hyperplasia 1 (2%) 1 (2%) 5 (10%) Nasolacrimal Duct, Inflammation, Suppurative 1 (2%) 1 (2%) 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 11 NTP Experiment-Test: 97006-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC METHYL ISOBUTYL KETONE Date: 05/11/04 Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 08:44:57 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE CONTROL 450 PPM 900 PPM 1800 PPM ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM - CONT Respiratory Epithelium, Hyperplasia 4 (8%) 1 (2%) 3 (6%) 3 (6%) Pleura (50) (49) (50) (50) Fibrosis 3 (6%) Inflammation, Chronic 6 (12%) 6 (12%) 4 (8%) Mesothelium, Hyperplasia 1 (2%) 1 (2%) Trachea (50) (48) (50) (50) Inflammation, Suppurative 2 (4%) Epithelium, Hyperplasia 1 (2%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (49) (45) (46) (48) Anterior Chamber, Hemorrhage 1 (2%) Anterior Chamber, Inflammation, Suppurative 1 (2%) Cornea, Hyperplasia 1 (2%) Lens, Cataract 7 (14%) 6 (13%) 3 (7%) 2 (4%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (50) (50) (50) Infarct 4 (8%) 3 (6%) Nephropathy 42 (84%) 45 (90%) 47 (94%) 50 (100%) Papilla, Mineralization 1 (2%) 6 (12%) 22 (44%) 29 (58%) Pelvis, Dilatation 1 (2%) Pelvis, Transitional Epithelium, Hyperplasia 1 (2%) 5 (10%) 6 (12%) 19 (38%) Renal Tubule, Accumulation, Hyaline Droplet 2 (4%) 2 (4%) Renal Tubule, Cyst 1 (2%) 1 (2%) 1 (2%) Renal Tubule, Hyperplasia 1 (2%) 11 (22%) 3 (6%) 18 (36%) Renal Tubule, Pigmentation 1 (2%) Transitional Epithelium, Hyperplasia 1 (2%) Urinary Bladder (50) (48) (50) (50) Calculus Micro Observation Only 1 (2%) 2 (4%) 2 (4%) Transitional Epithelium, Hyperplasia 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 12 ------------------------------------------------------------ ---------- END OF REPORT ---------- ------------------------------------------------------------