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
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