TDMS Study 05185-03 Pathology Tables
INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) ISOBUTYL NITRITE (IBN) NTP Experiment-Test: 05185-03 Report: PEIRPT03 Study Type: CHRONIC Date: 05/20/95 Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 10:47:26 Facility: I. I. T. Research Institute Chemical CAS #: 542-56-3 Lock Date: 05/22/92 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: 05185-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC ISOBUTYL NITRITE (IBN) Date: 05/20/95 Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 10:47:26 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE CONTROL 37.5 PPM 75 PPM 150 PPM ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 56 56 56 56 Scheduled Sacrifice 10 10 10 10 Early Deaths Moribund Sacrifice 13 4 7 6 Natural Death 4 6 8 7 Survivors Terminal Sacrifice 29 35 30 33 Natural Death 1 Missing 1 Animals Examined Microscopically 56 55 56 56 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Colon (56) (54) (54) (54) Abscess 1 (2%) Intestine Large, Cecum (56) (54) (53) (53) Inflammation 1 (2%) Necrosis 1 (2%) Intestine Small, Ileum (54) (51) (50) (51) Inflammation 1 (2%) Liver (56) (54) (56) (56) Angiectasis 1 (2%) 2 (4%) Basophilic Focus 7 (13%) 6 (11%) 15 (27%) 7 (13%) Basophilic Focus, Multiple 22 (39%) 34 (63%) 30 (54%) 40 (71%) Clear Cell Focus 3 (5%) 1 (2%) 2 (4%) 2 (4%) Clear Cell Focus, Multiple 1 (2%) 1 (2%) Congestion 1 (2%) 3 (5%) 4 (7%) Developmental Malformation 2 (4%) 2 (4%) Eosinophilic Focus 1 (2%) 8 (15%) 5 (9%) 2 (4%) Eosinophilic Focus, Multiple 3 (5%) 1 (2%) Fatty Change 10 (18%) 4 (7%) 9 (16%) 4 (7%) Hematopoietic Cell Proliferation 4 (7%) Hemorrhage 1 (2%) 1 (2%) Hepatodiaphragmatic Nodule 3 (5%) 3 (6%) 5 (9%) 6 (11%) Infiltration Cellular, Lymphocyte 1 (2%) 1 (2%) 1 (2%) Inflammation 4 (7%) 3 (6%) 6 (11%) 2 (4%) Mixed Cell Focus 2 (4%) 2 (4%) Necrosis 3 (5%) 1 (2%) 1 (2%) 3 (5%) Pigmentation 1 (2%) 1 (2%) Vacuolization Cytoplasmic 4 (7%) Centrilobular, Cytoplasmic Alteration 1 (2%) Mesentery (1) (4) (2) Fat, Necrosis 1 (100%) 4 (100%) 2 (100%) a Number of animals examined microscopically at site and number of animals with lesion Page 2 NTP Experiment-Test: 05185-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC ISOBUTYL NITRITE (IBN) Date: 05/20/95 Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 10:47:26 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE CONTROL 37.5 PPM 75 PPM 150 PPM ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Pancreas (56) (55) (56) (56) Accessory Spleen 1 (2%) 1 (2%) Ectopic Liver 2 (4%) Infiltration Cellular, Lymphocyte 1 (2%) Acinar Cell, Atrophy 19 (34%) 28 (51%) 26 (46%) 25 (45%) Salivary Glands (56) (55) (55) (56) Inflammation 1 (2%) Stomach, Forestomach (56) (55) (56) (56) Hyperplasia 2 (4%) 3 (5%) 1 (2%) Inflammation 1 (2%) 1 (2%) 1 (2%) Ulcer 3 (5%) 2 (4%) Ulcer, Multiple 2 (4%) 1 (2%) Stomach, Glandular (56) (54) (55) (56) Inflammation 1 (2%) 1 (2%) Ulcer 2 (4%) 1 (2%) Ulcer, Multiple 1 (2%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (56) (55) (56) (56) Cardiomyopathy 38 (68%) 30 (55%) 34 (61%) 41 (73%) Atrium, Thrombosis 2 (4%) 2 (4%) Endocardium, Proliferation 1 (2%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (56) (55) (56) (56) Angiectasis 4 (7%) 7 (13%) 10 (18%) 10 (18%) Congestion 1 (2%) 1 (2%) Cyst 1 (2%) Cytoplasmic Alteration 1 (2%) Degeneration 1 (2%) 2 (4%) 1 (2%) 1 (2%) Hemorrhage 1 (2%) 1 (2%) 1 (2%) 4 (7%) Hyperplasia 5 (9%) 5 (9%) 3 (5%) Hypertrophy 1 (2%) 1 (2%) 1 (2%) 1 (2%) Infiltration Cellular, Lymphocyte 1 (2%) Necrosis 1 (2%) Vacuolization Cytoplasmic 8 (14%) 13 (24%) 6 (11%) 10 (18%) Adrenal Medulla (55) (55) (55) (56) Angiectasis 1 (2%) Hyperplasia 2 (4%) 4 (7%) 3 (5%) 5 (9%) Pituitary Gland (56) (53) (55) (56) Angiectasis 1 (2%) Congestion 1 (2%) Cyst 3 (5%) 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 3 NTP Experiment-Test: 05185-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC ISOBUTYL NITRITE (IBN) Date: 05/20/95 Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 10:47:26 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE CONTROL 37.5 PPM 75 PPM 150 PPM ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM - CONT Hyperplasia 1 (2%) Pars Distalis, Angiectasis 11 (20%) 12 (23%) 5 (9%) 7 (13%) Pars Distalis, Cyst 16 (29%) 21 (40%) 13 (24%) 9 (16%) Pars Distalis, Hyperplasia 9 (16%) 24 (45%) 15 (27%) 21 (38%) Pars Nervosa, Developmental Malformation 1 (2%) Thyroid Gland (56) (55) (56) (56) C-Cell, Hyperplasia 8 (14%) 4 (7%) 5 (9%) 6 (11%) Follicle, Dilatation 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM Tissue NOS (1) Developmental Malformation 1 (100%) ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Clitoral Gland (54) (54) (54) (56) Abscess 1 (2%) 1 (2%) Ectasia 32 (59%) 33 (61%) 38 (70%) 37 (66%) Hyperplasia 2 (4%) 4 (7%) 1 (2%) 6 (11%) Inflammation 2 (4%) 3 (6%) 5 (9%) 2 (4%) Ovary (56) (55) (56) (56) Cyst 5 (9%) 9 (16%) 2 (4%) 2 (4%) Hemorrhage 1 (2%) Bilateral, Cyst 1 (2%) 1 (2%) Corpus Luteum, Hyperplasia 1 (2%) Uterus (56) (55) (56) (56) Angiectasis 1 (2%) Cyst 1 (2%) 2 (4%) Dilatation 1 (2%) 2 (4%) 5 (9%) 2 (4%) Hemorrhage 1 (2%) Prolapse 1 (2%) Bilateral, Dilatation 2 (4%) Endometrium, Hyperplasia 1 (2%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (56) (55) (56) (56) Atrophy 2 (4%) Hyperplasia 7 (13%) 7 (13%) 6 (11%) 6 (11%) Myelofibrosis 1 (2%) 1 (2%) 2 (4%) Lymph Node (1) (1) (3) Axillary, Hyperplasia, Lymphoid 1 (100%) 1 (33%) Axillary, Hyperplasia, Plasma Cell 1 (100%) a Number of animals examined microscopically at site and number of animals with lesion Page 4 NTP Experiment-Test: 05185-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC ISOBUTYL NITRITE (IBN) Date: 05/20/95 Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 10:47:26 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE CONTROL 37.5 PPM 75 PPM 150 PPM ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - CONT Lumbar, Cyst 1 (100%) Lumbar, Hyperplasia, Lymphoid 1 (100%) Lumbar, Pigmentation 1 (100%) 1 (33%) Lymph Node, Bronchial (36) (40) (46) (38) Hemorrhage 12 (33%) 23 (58%) 22 (48%) 20 (53%) Pigmentation 2 (6%) 7 (18%) 9 (20%) 7 (18%) Lymph Node, Mandibular (55) (55) (53) (53) Cyst 1 (2%) Hemorrhage 2 (4%) 1 (2%) 2 (4%) 1 (2%) Hyperplasia, Lymphoid 1 (2%) 1 (2%) Hyperplasia, Plasma Cell 2 (4%) 3 (5%) 1 (2%) Pigmentation 2 (4%) Lymph Node, Mesenteric (56) (55) (56) (55) Edema 1 (2%) Hemorrhage 8 (14%) 8 (15%) 8 (14%) 8 (15%) Pigmentation 1 (2%) 1 (2%) Lymph Node, Mediastinal (54) (54) (51) (53) Hemorrhage 37 (69%) 41 (76%) 41 (80%) 35 (66%) Infiltration Cellular, Histiocyte 1 (2%) Pigmentation 22 (41%) 31 (57%) 31 (61%) 17 (32%) Spleen (56) (55) (54) (56) Congestion 1 (2%) Developmental Malformation 1 (2%) Hematopoietic Cell Proliferation 5 (9%) 11 (20%) 7 (13%) 10 (18%) Pigmentation 1 (2%) 3 (6%) 3 (5%) Thymus (54) (53) (55) (54) Atrophy 44 (81%) 26 (49%) 34 (62%) 24 (44%) Congestion 1 (2%) 1 (2%) Cyst 1 (2%) Hemorrhage 2 (4%) 4 (7%) 7 (13%) Necrosis 1 (2%) Pigmentation 1 (2%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (56) (55) (56) (56) Abscess 1 (2%) Galactocele 1 (2%) Hemorrhage 1 (2%) Hyperplasia 1 (2%) Inflammation 2 (4%) Lactation 17 (30%) 7 (13%) 9 (16%) 8 (14%) Skin (56) (55) (56) (56) Abscess 1 (2%) Ulcer 1 (2%) Ulcer, Multiple 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 5 NTP Experiment-Test: 05185-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC ISOBUTYL NITRITE (IBN) Date: 05/20/95 Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 10:47:26 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE CONTROL 37.5 PPM 75 PPM 150 PPM ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM - CONT Tail, Hyperkeratosis 1 (2%) Tail, Parakeratosis 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (56) (55) (56) (56) Femur, Hyperostosis 6 (11%) 2 (4%) 5 (9%) Turbinate, Hyperostosis 3 (5%) 2 (4%) 2 (4%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (56) (55) (56) (56) Compression 13 (23%) 8 (15%) 15 (27%) 10 (18%) Cyst 1 (2%) Hemorrhage 2 (4%) 5 (9%) 2 (4%) Hydrocephalus 3 (5%) 1 (2%) 1 (2%) Necrosis 3 (5%) Thrombosis 1 (2%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Larynx (56) (55) (56) (56) Foreign Body 1 (2%) Hemorrhage 1 (2%) Infiltration Cellular, Lymphocyte 3 (5%) Inflammation 3 (5%) 4 (7%) 6 (11%) Metaplasia, Squamous 1 (2%) Epithelium, Hyperplasia 2 (4%) 2 (4%) Lung (56) (55) (56) (56) Congestion 4 (7%) 6 (11%) 2 (4%) Hemorrhage 10 (18%) 15 (27%) 10 (18%) 9 (16%) Infiltration Cellular, Histiocyte 1 (2%) 1 (2%) 1 (2%) 2 (4%) Inflammation 4 (7%) 4 (7%) 3 (5%) 3 (5%) Alveolar Epithelium, Hyperplasia 4 (7%) 12 (22%) 12 (21%) 35 (63%) Nose (56) (55) (55) (56) Angiectasis 1 (2%) 3 (5%) 1 (2%) Foreign Body 2 (4%) 1 (2%) 1 (2%) Hemorrhage 1 (2%) 1 (2%) Inflammation 7 (13%) 5 (9%) 4 (7%) 7 (13%) Goblet Cell, Hyperplasia 1 (2%) 4 (7%) 2 (4%) 3 (5%) Nasolacrimal Duct, Inflammation 2 (4%) 2 (4%) 2 (4%) Olfactory Epithelium, Cytoplasmic Alteration 2 (4%) 3 (5%) 9 (16%) Respiratory Epithelium, Hyperplasia 3 (5%) 2 (4%) 2 (4%) Trachea (56) (55) (56) (56) a Number of animals examined microscopically at site and number of animals with lesion Page 6 NTP Experiment-Test: 05185-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC ISOBUTYL NITRITE (IBN) Date: 05/20/95 Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 10:47:26 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE CONTROL 37.5 PPM 75 PPM 150 PPM ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM - CONT Inflammation 1 (2%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (1) (1) Hemorrhage 1 (100%) Bilateral, Lens, Cataract 1 (100%) Lens, Cataract 1 (100%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (56) (55) (56) (56) Angiectasis 1 (2%) Congestion 1 (2%) 1 (2%) 1 (2%) Cyst 1 (2%) Hypoplasia 1 (2%) Infarct 1 (2%) Mineralization 14 (25%) 16 (29%) 15 (27%) 17 (30%) Necrosis 1 (2%) Nephropathy, Chronic 52 (93%) 44 (80%) 43 (77%) 44 (79%) Pigmentation 3 (5%) 4 (7%) 1 (2%) Transitional Epithelium, Hyperplasia 1 (2%) Urinary Bladder (56) (54) (55) (52) Dilatation 1 (2%) 1 (2%) Infiltration Cellular, Lymphocyte 1 (2%) Arteriole, Inflammation 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 7 NTP Experiment-Test: 05185-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC ISOBUTYL NITRITE (IBN) Date: 05/20/95 Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 10:47:26 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE CONTROL 37.5 PPM 75 PPM 150 PPM ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 56 56 56 56 Scheduled Sacrifice 10 10 10 10 Early Deaths Moribund Sacrifice 21 12 5 8 Natural Death 8 11 4 10 Accidently Killed 1 Survivors Terminal Sacrifice 17 23 36 28 Animals Examined Microscopically 56 56 56 56 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Esophagus (55) (56) (56) (56) Ectasia 1 (2%) Intestine Large, Colon (55) (55) (56) (55) Infiltration Cellular, Lipocyte 1 (2%) Intestine Large, Rectum (54) (54) (55) (55) Inflammation 1 (2%) Intestine Large, Cecum (54) (51) (54) (53) Inflammation 1 (2%) Intestine Small, Duodenum (54) (54) (56) (55) Ectopic Tissue 1 (2%) Hyperplasia 1 (2%) Inflammation 1 (2%) Intestine Small, Ileum (53) (46) (53) (52) Hemorrhage 1 (2%) Hyperplasia, Lymphoid 1 (2%) Liver (55) (56) (56) (56) Basophilic Focus 9 (16%) 11 (20%) 6 (11%) 7 (13%) Basophilic Focus, Multiple 6 (11%) 11 (20%) 26 (46%) 22 (39%) Clear Cell Focus 3 (5%) 1 (2%) 8 (14%) 2 (4%) Clear Cell Focus, Multiple 2 (4%) 9 (16%) 8 (14%) 3 (5%) Congestion 3 (5%) 2 (4%) 7 (13%) Cytoplasmic Alteration 1 (2%) Degeneration, Cystic 4 (7%) 12 (21%) 15 (27%) 4 (7%) Developmental Malformation 1 (2%) Eosinophilic Focus 5 (9%) 7 (13%) 8 (14%) 2 (4%) Eosinophilic Focus, Multiple 1 (2%) 4 (7%) 10 (18%) 4 (7%) Fatty Change 5 (9%) 12 (21%) 7 (13%) 14 (25%) Hemorrhage 2 (4%) 3 (5%) Hepatodiaphragmatic Nodule 1 (2%) 2 (4%) Infiltration Cellular, Lymphocyte 1 (2%) Inflammation 1 (2%) 1 (2%) 1 (2%) 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 8 NTP Experiment-Test: 05185-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC ISOBUTYL NITRITE (IBN) Date: 05/20/95 Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 10:47:26 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE CONTROL 37.5 PPM 75 PPM 150 PPM ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Mixed Cell Focus 1 (2%) 4 (7%) 2 (4%) 4 (7%) Mixed Cell Focus, Multiple 2 (4%) 2 (4%) Necrosis 2 (4%) 4 (7%) 2 (4%) 2 (4%) Pigmentation 1 (2%) Bile Duct, Hyperplasia 3 (5%) 3 (5%) Mesentery (6) (1) (4) (10) Fat, Necrosis 6 (100%) 1 (100%) 4 (100%) 8 (80%) Pancreas (55) (56) (56) (56) Ectopic Liver 1 (2%) Infiltration Cellular, Lymphocyte 2 (4%) 1 (2%) Inflammation 1 (2%) 2 (4%) Acinar Cell, Atrophy 33 (60%) 32 (57%) 36 (64%) 32 (57%) Acinar Cell, Hyperplasia 1 (2%) Artery, Inflammation 2 (4%) Duct, Ectasia 1 (2%) 1 (2%) Pharynx (1) Palate, Hyperplasia, Squamous 1 (100%) Salivary Glands (56) (55) (56) (56) Abscess 1 (2%) Infiltration Cellular, Lymphocyte 1 (2%) Stomach, Forestomach (55) (56) (56) (56) Hyperplasia 4 (7%) 3 (5%) 5 (9%) 3 (5%) Inflammation 1 (2%) 4 (7%) 3 (5%) 1 (2%) Ulcer 5 (9%) 3 (5%) 2 (4%) 3 (5%) Ulcer, Multiple 2 (4%) 2 (4%) Stomach, Glandular (55) (56) (56) (55) Hyperplasia 1 (2%) Inflammation 1 (2%) 1 (2%) 2 (4%) Necrosis 3 (5%) 3 (5%) Ulcer 1 (2%) 3 (5%) Ulcer, Multiple 2 (4%) 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (56) (56) (56) (56) Cardiomyopathy 42 (75%) 53 (95%) 55 (98%) 51 (91%) Inflammation 2 (4%) Atrium, Dilatation 1 (2%) 1 (2%) Atrium, Thrombosis 2 (4%) 1 (2%) 2 (4%) 2 (4%) Valve, Inflammation 1 (2%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 9 NTP Experiment-Test: 05185-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC ISOBUTYL NITRITE (IBN) Date: 05/20/95 Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 10:47:26 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE CONTROL 37.5 PPM 75 PPM 150 PPM ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (55) (56) (56) (56) Angiectasis 1 (2%) Congestion 1 (2%) 1 (2%) Cytoplasmic Alteration 1 (2%) 1 (2%) Degeneration 3 (5%) 1 (2%) 1 (2%) 2 (4%) Hyperplasia 7 (13%) 4 (7%) 6 (11%) 3 (5%) Hypertrophy 1 (2%) 3 (5%) 2 (4%) 2 (4%) Vacuolization Cytoplasmic 7 (13%) 19 (34%) 15 (27%) 16 (29%) Adrenal Medulla (54) (55) (56) (56) Angiectasis 1 (2%) Hyperplasia 15 (28%) 14 (25%) 19 (34%) 12 (21%) Islets, Pancreatic (8) (9) (5) (5) Hyperplasia 4 (50%) 3 (33%) 2 (40%) 1 (20%) Parathyroid Gland (49) (50) (48) (52) Hyperplasia 4 (8%) 6 (12%) 3 (6%) Pituitary Gland (55) (56) (56) (55) Hemorrhage 1 (2%) Pars Distalis, Angiectasis 1 (2%) 7 (13%) 4 (7%) 4 (7%) Pars Distalis, Cyst 2 (4%) 5 (9%) 4 (7%) 3 (5%) Pars Distalis, Hemorrhage 1 (2%) 1 (2%) Pars Distalis, Hyperplasia 11 (20%) 22 (39%) 25 (45%) 18 (33%) Pars Intermedia, Angiectasis 1 (2%) Pars Intermedia, Cyst 1 (2%) Thyroid Gland (55) (56) (56) (56) C-Cell, Hyperplasia 8 (15%) 5 (9%) 5 (9%) 3 (5%) Follicle, Dilatation 4 (7%) Follicular Cell, Hyperplasia 1 (2%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Epididymis (56) (56) (56) (56) Atrophy 1 (2%) 1 (2%) Granuloma Sperm 1 (2%) 2 (4%) 1 (2%) 1 (2%) Hypospermia 20 (36%) 26 (46%) 25 (45%) 29 (52%) Inflammation 2 (4%) 2 (4%) Inflammation, Chronic 1 (2%) Spermatocele 2 (4%) Preputial Gland (54) (56) (56) (56) Abscess 1 (2%) 1 (2%) Degeneration 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 10 NTP Experiment-Test: 05185-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC ISOBUTYL NITRITE (IBN) Date: 05/20/95 Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 10:47:26 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE CONTROL 37.5 PPM 75 PPM 150 PPM ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM - CONT Ectasia 43 (80%) 49 (88%) 49 (88%) 41 (73%) Hyperplasia 1 (2%) 3 (5%) 1 (2%) Inflammation 11 (20%) 9 (16%) 12 (21%) 16 (29%) Prostate (56) (56) (56) (56) Abscess 1 (2%) Atrophy 1 (2%) Concretion 6 (11%) 7 (13%) 7 (13%) 10 (18%) Congestion 1 (2%) Hyperplasia 5 (9%) 4 (7%) 6 (11%) 4 (7%) Inflammation 32 (57%) 24 (43%) 23 (41%) 25 (45%) Vacuolization Cytoplasmic 1 (2%) Epithelium, Cytoplasmic Alteration 1 (2%) 2 (4%) Seminal Vesicle (55) (56) (56) (56) Depletion Cellular 22 (40%) 23 (41%) 23 (41%) 31 (55%) Ectasia 1 (2%) 1 (2%) Inflammation 1 (2%) 2 (4%) Testes (56) (56) (56) (56) Atrophy 8 (14%) 6 (11%) 6 (11%) 8 (14%) Degeneration 1 (2%) Hypospermia 1 (2%) 1 (2%) Arteriole, Inflammation 1 (2%) 6 (11%) 10 (18%) 5 (9%) Bilateral, Atrophy 10 (18%) 2 (4%) 4 (7%) 7 (13%) Bilateral, Degeneration 1 (2%) Interstitial Cell, Hyperplasia 16 (29%) 12 (21%) 12 (21%) 14 (25%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (55) (55) (56) (56) Congestion 1 (2%) Hemorrhage 1 (2%) Hyperplasia 16 (29%) 15 (27%) 8 (14%) 15 (27%) Pigmentation 1 (2%) Lymph Node (5) (1) Deep Cervical, Inflammation 1 (100%) Lumbar, Hyperplasia, Plasma Cell 1 (20%) Renal, Hemorrhage 1 (100%) Lymph Node, Bronchial (47) (43) (40) (39) Hemorrhage 10 (21%) 18 (42%) 18 (45%) 18 (46%) Hyperplasia, Plasma Cell 1 (2%) Infiltration Cellular, Histiocyte 1 (3%) Inflammation 1 (2%) Pigmentation 1 (2%) 3 (7%) 2 (5%) 3 (8%) Lymph Node, Mandibular (55) (55) (56) (56) Cyst 1 (2%) 2 (4%) Hemorrhage 6 (11%) 4 (7%) 7 (13%) 3 (5%) Hyperplasia, Lymphoid 1 (2%) 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 11 NTP Experiment-Test: 05185-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC ISOBUTYL NITRITE (IBN) Date: 05/20/95 Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 10:47:26 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE CONTROL 37.5 PPM 75 PPM 150 PPM ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - CONT Hyperplasia, Plasma Cell 3 (5%) 7 (13%) 6 (11%) 4 (7%) Infiltration Cellular, Histiocyte 1 (2%) Pigmentation 1 (2%) 1 (2%) Lymph Node, Mesenteric (55) (56) (56) (54) Hemorrhage 4 (7%) 12 (21%) 5 (9%) 7 (13%) Lymph Node, Mediastinal (55) (52) (52) (55) Depletion Lymphoid 1 (2%) Hemorrhage 22 (40%) 36 (69%) 33 (63%) 36 (65%) Hyperplasia, Lymphoid 1 (2%) Hyperplasia, Plasma Cell 3 (5%) 2 (4%) 2 (4%) Infiltration Cellular, Histiocyte 1 (2%) 1 (2%) Pigmentation 5 (9%) 14 (27%) 13 (25%) 12 (22%) Spleen (56) (55) (56) (55) Congestion 1 (2%) 2 (4%) 1 (2%) Degeneration, Cystic 2 (4%) 5 (9%) Developmental Malformation 1 (2%) Fibrosis 1 (2%) 2 (4%) Hematopoietic Cell Proliferation 4 (7%) 6 (11%) 5 (9%) 13 (24%) Hemorrhage 1 (2%) Inflammation 1 (2%) Necrosis 1 (2%) Capsule, Fibrosis 1 (2%) Thymus (51) (56) (55) (54) Atrophy 35 (69%) 43 (77%) 42 (76%) 41 (76%) Congestion 2 (4%) Cyst 1 (2%) Hemorrhage 3 (6%) 8 (14%) 2 (4%) 3 (6%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (52) (53) (56) (53) Galactocele 1 (2%) 2 (4%) 4 (8%) Hyperplasia 1 (2%) 1 (2%) Inflammation 1 (2%) 1 (2%) Lactation 13 (25%) 18 (34%) 10 (18%) 16 (30%) Pigmentation 2 (4%) 1 (2%) Skin (56) (56) (56) (56) Inflammation 1 (2%) Pinna, Parakeratosis 1 (2%) Subcutaneous Tissue, Abscess 1 (2%) 1 (2%) Tail, Hyperkeratosis 1 (2%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 12 NTP Experiment-Test: 05185-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC ISOBUTYL NITRITE (IBN) Date: 05/20/95 Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 10:47:26 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE CONTROL 37.5 PPM 75 PPM 150 PPM ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (56) (56) (56) (56) Calvarium, Hemorrhage 1 (2%) Coccygeal, Fracture 1 (2%) Cranium, Hemorrhage 1 (2%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (56) (56) (56) (56) Compression 9 (16%) 17 (30%) 6 (11%) 22 (39%) Hemorrhage 2 (4%) 2 (4%) 1 (2%) 1 (2%) Hydrocephalus 4 (7%) 3 (5%) 1 (2%) 2 (4%) Infiltration Cellular, Lymphocyte 1 (2%) Necrosis 1 (2%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Larynx (56) (56) (56) (56) Foreign Body 1 (2%) 1 (2%) Infiltration Cellular, Lymphocyte 3 (5%) 1 (2%) 2 (4%) Inflammation 3 (5%) 2 (4%) 4 (7%) 4 (7%) Epithelium, Hyperplasia 1 (2%) 1 (2%) 1 (2%) 1 (2%) Lung (56) (56) (56) (56) Congestion 4 (7%) 5 (9%) 3 (5%) 3 (5%) Hemorrhage 9 (16%) 15 (27%) 4 (7%) 3 (5%) Infiltration Cellular, Histiocyte 1 (2%) 1 (2%) Inflammation 3 (5%) 8 (14%) 3 (5%) 6 (11%) Leukocytosis 1 (2%) 1 (2%) Necrosis 1 (2%) Alveolar Epithelium, Hyperplasia 5 (9%) 11 (20%) 28 (50%) 38 (68%) Arteriole, Inflammation 1 (2%) Artery, Inflammation 1 (2%) Artery, Thrombosis 1 (2%) 1 (2%) Bronchus, Hyperplasia 1 (2%) Goblet Cell, Hyperplasia 1 (2%) Nose (55) (55) (56) (56) Angiectasis 7 (13%) 4 (7%) 1 (2%) 2 (4%) Foreign Body 6 (11%) 3 (5%) 3 (5%) 2 (4%) Hemorrhage 5 (9%) 2 (4%) 1 (2%) Infiltration Cellular, Lymphocyte 2 (4%) Inflammation 9 (16%) 10 (18%) 7 (13%) 11 (20%) Polyp Inflammatory 1 (2%) Goblet Cell, Hyperplasia 3 (5%) 3 (5%) 1 (2%) Nasolacrimal Duct, Inflammation 3 (5%) 2 (4%) Olfactory Epithelium, Cytoplasmic Alteration 3 (5%) 2 (4%) 5 (9%) a Number of animals examined microscopically at site and number of animals with lesion Page 13 NTP Experiment-Test: 05185-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC ISOBUTYL NITRITE (IBN) Date: 05/20/95 Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 10:47:26 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE CONTROL 37.5 PPM 75 PPM 150 PPM ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM - CONT Respiratory Epithelium, Hyperplasia 2 (4%) 3 (5%) 4 (7%) 4 (7%) Respiratory Epithelium, Metaplasia, Squamous 2 (4%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (1) (1) Hemorrhage 1 (100%) Inflammation 1 (100%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (55) (55) (56) (56) Congestion 1 (2%) 1 (2%) Cyst 1 (2%) 1 (2%) 3 (5%) Hydronephrosis 1 (2%) Inflammation 1 (2%) Nephropathy, Chronic 49 (89%) 52 (95%) 55 (98%) 55 (98%) Pigmentation 3 (5%) 2 (4%) 5 (9%) Pelvis, Hyperplasia 1 (2%) Renal Tubule, Cytoplasmic Alteration 1 (2%) Urinary Bladder (56) (55) (56) (55) Calculus Micro Observation Only 1 (2%) Dilatation 4 (7%) 1 (2%) 1 (2%) Infiltration Cellular, Lymphocyte 1 (2%) Inflammation 1 (2%) 1 (2%) Transitional Epithelium, Hyperplasia 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 14 ------------------------------------------------------------ ---------- END OF REPORT ---------- ------------------------------------------------------------