TDMS Study 05185-04 Pathology Tables
INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) ISOBUTYL NITRITE (IBN) NTP Experiment-Test: 05185-04 Report: PEIRPT03 Study Type: CHRONIC Date: 05/20/95 Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 11:28:48 Facility: I. I. T. Research Institute Chemical CAS #: 542-56-3 Lock Date: 08/20/92 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: 05185-04 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: 11:28:48 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE CONTROL 37.5 PPM 75 PPM 150 PPM ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 60 60 60 60 Scheduled Sacrifice 9 9 9 10 Early Deaths Natural Death 16 6 8 10 Moribund Sacrifice 3 3 6 2 Accidently Killed 1 Survivors Terminal Sacrifice 32 42 36 37 Other 1 Animals Examined Microscopically 60 60 59 60 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Gallbladder (55) (55) (54) (51) Dilatation 1 (2%) Inflammation, Chronic 1 (2%) 1 (2%) Intestine Large, Rectum (57) (60) (59) (57) Dilatation 1 (2%) Intestine Large, Cecum (57) (58) (59) (55) Dilatation 1 (2%) Hyperplasia, Lymphoid 1 (2%) Intestine Small, Duodenum (51) (59) (58) (52) Ectopic Tissue 1 (2%) Proliferation Connective Tissue 1 (2%) Intestine Small, Jejunum (53) (59) (56) (55) Hyperplasia, Lymphoid 1 (2%) Proliferation Connective Tissue 1 (2%) Serosa, Inflammation, Chronic Active 1 (2%) Intestine Small, Ileum (53) (57) (59) (54) Dilatation 1 (2%) Liver (60) (60) (59) (60) Angiectasis 1 (2%) Basophilic Focus 2 (3%) 1 (2%) Clear Cell Focus 1 (2%) 2 (3%) 1 (2%) Cytologic Alterations 2 (3%) 1 (2%) 1 (2%) Eosinophilic Focus 1 (2%) 2 (3%) Fatty Change, Diffuse 1 (2%) Fibrosis 1 (2%) Hematopoietic Cell Proliferation 1 (2%) 1 (2%) 1 (2%) Hemorrhage 1 (2%) Hyperplasia 2 (3%) Infarct 1 (2%) 1 (2%) Inflammation, Chronic 11 (18%) 7 (12%) 6 (10%) 7 (12%) a Number of animals examined microscopically at site and number of animals with lesion Page 2 NTP Experiment-Test: 05185-04 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: 11:28:48 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE CONTROL 37.5 PPM 75 PPM 150 PPM ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Inflammation, Chronic Active 2 (3%) 2 (3%) 4 (7%) Mitotic Alteration 1 (2%) Mixed Cell Focus 3 (5%) 1 (2%) 1 (2%) 2 (3%) Necrosis 1 (2%) 2 (3%) 2 (3%) 1 (2%) Pigmentation 1 (2%) Proliferation Connective Tissue 1 (2%) Fat, Necrosis 1 (2%) Hepatocyte, Necrosis 1 (2%) 1 (2%) 1 (2%) Periportal, Fatty Change 1 (2%) 1 (2%) Periportal, Hypertrophy 1 (2%) Mesentery (7) (4) (3) (2) Cyst 1 (25%) Proliferation Connective Tissue 1 (25%) Artery, Inflammation, Chronic 1 (14%) Fat, Necrosis 5 (71%) 4 (100%) 2 (67%) 2 (100%) Pancreas (60) (60) (59) (60) Fibrosis 1 (2%) Inflammation, Chronic 4 (7%) 3 (5%) Inflammation, Chronic Active 1 (2%) Acinus, Atrophy 1 (2%) 2 (3%) 3 (5%) 2 (3%) Duct, Dilatation 1 (2%) 1 (2%) Salivary Glands (60) (60) (59) (60) Atrophy 1 (2%) Hemorrhage 1 (2%) Inflammation, Chronic 49 (82%) 44 (73%) 33 (56%) 32 (53%) Inflammation, Chronic Active 1 (2%) Stomach, Forestomach (60) (60) (59) (59) Angiectasis 1 (2%) Developmental Malformation 1 (2%) Proliferation Connective Tissue 1 (2%) Ulcer 1 (2%) Stomach, Glandular (60) (60) (59) (59) Proliferation Connective Tissue 1 (2%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (60) (60) (59) (60) Infiltration Cellular 1 (2%) Inflammation, Chronic 1 (2%) Thrombosis 1 (2%) 1 (2%) Artery, Hypertrophy 1 (2%) Artery, Inflammation, Chronic 1 (2%) 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 3 NTP Experiment-Test: 05185-04 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: 11:28:48 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE CONTROL 37.5 PPM 75 PPM 150 PPM ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (59) (60) (59) (59) Cyst 3 (5%) Hyperplasia, Focal 2 (3%) Hypertrophy, Focal 1 (2%) 2 (3%) Subcapsular, Hyperplasia 56 (95%) 56 (93%) 54 (92%) 53 (90%) Adrenal Medulla (55) (58) (54) (57) Hyperplasia, Focal 2 (3%) 1 (2%) Islets, Pancreatic (2) (2) (3) (3) Hyperplasia, Focal 2 (100%) 1 (50%) 3 (100%) 2 (67%) Pituitary Gland (56) (56) (59) (57) Cyst 1 (2%) Pars Distalis, Angiectasis 1 (2%) 1 (2%) 2 (4%) Pars Distalis, Cyst 1 (2%) 1 (2%) 1 (2%) 2 (4%) Pars Distalis, Hemorrhage 1 (2%) Pars Distalis, Hyperplasia 10 (18%) 12 (21%) 12 (20%) 7 (12%) Pars Distalis, Hyperplasia, Focal 1 (2%) Thyroid Gland (60) (60) (59) (60) Ectopic Thymus 1 (2%) Infiltration Cellular, Lymphocyte 1 (2%) Inflammation, Chronic 3 (5%) Follicle, Cyst 1 (2%) 5 (8%) 4 (7%) Follicular Cell, Hyperplasia, Diffuse 1 (2%) 1 (2%) Follicular Cell, Hyperplasia, Focal 5 (8%) 9 (15%) 7 (12%) 5 (8%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Clitoral Gland (1) (2) (5) Dilatation 1 (100%) 1 (50%) 1 (20%) Pigmentation 3 (60%) Ovary (58) (59) (55) (59) Angiectasis 1 (2%) Cyst 10 (17%) 15 (25%) 10 (18%) 13 (22%) Hemorrhage 1 (2%) Infiltration Cellular, Lymphocyte 1 (2%) 1 (2%) Interstitium, Hyperplasia 1 (2%) Uterus (60) (60) (58) (59) Angiectasis 2 (3%) 1 (2%) Developmental Malformation 1 (2%) Dilatation 1 (2%) Hemorrhage 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 4 NTP Experiment-Test: 05185-04 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: 11:28:48 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE CONTROL 37.5 PPM 75 PPM 150 PPM ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM - CONT Hyperplasia 1 (2%) Hyperplasia, Cystic 49 (82%) 51 (85%) 50 (86%) 54 (92%) Inflammation, Chronic Active 1 (2%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (60) (60) (59) (60) Atrophy 1 (2%) Degeneration, Fatty 1 (2%) Myeloid Cell, Hyperplasia 1 (2%) 3 (5%) Lymph Node (4) (5) (8) (6) Hyperplasia, Lymphoid 1 (20%) Pigmentation 1 (20%) Iliac, Hemorrhage 1 (13%) Iliac, Hyperplasia, Lymphoid 1 (20%) Iliac, Inflammation, Chronic Active 1 (13%) Iliac, Pigmentation 1 (17%) Inguinal, Pigmentation 1 (17%) Lumbar, Angiectasis 1 (13%) Lumbar, Hemorrhage 1 (13%) Lumbar, Hyperplasia, Lymphoid 1 (17%) Pancreatic, Hyperplasia, Lymphoid 1 (20%) Renal, Hemorrhage 1 (13%) Lymph Node, Bronchial (28) (42) (40) (38) Hemorrhage 1 (2%) 1 (3%) Hyperplasia, Lymphoid 1 (4%) 4 (10%) Lymph Node, Mandibular (58) (57) (57) (55) Hemorrhage 1 (2%) 2 (4%) 1 (2%) Hyperplasia, Lymphoid 2 (3%) 1 (2%) 2 (4%) 1 (2%) Inflammation, Chronic Active 1 (2%) Lymph Node, Mesenteric (60) (59) (58) (55) Angiectasis 1 (2%) Hematopoietic Cell Proliferation 1 (2%) Hemorrhage 1 (2%) 1 (2%) Hyperplasia, Lymphoid 1 (2%) 1 (2%) 1 (2%) Hyperplasia, Plasma Cell 1 (2%) Inflammation, Chronic Active 1 (2%) Lymph Node, Mediastinal (58) (51) (52) (53) Hyperplasia, Lymphoid 6 (10%) 4 (8%) 3 (6%) 3 (6%) Inflammation, Chronic Active 1 (2%) Spleen (60) (60) (59) (59) Angiectasis 1 (2%) Atrophy 1 (2%) Fibrosis 1 (2%) Hematopoietic Cell Proliferation 54 (90%) 49 (82%) 54 (92%) 54 (92%) Hyperplasia, Lymphoid 6 (10%) 7 (12%) 6 (10%) 3 (5%) a Number of animals examined microscopically at site and number of animals with lesion Page 5 NTP Experiment-Test: 05185-04 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: 11:28:48 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE CONTROL 37.5 PPM 75 PPM 150 PPM ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - CONT Pigmentation, Hemosiderin 54 (90%) 52 (87%) 46 (78%) 57 (97%) Proliferation Connective Tissue 1 (2%) Thymus (56) (56) (57) (51) Atrophy 11 (20%) 2 (4%) 5 (9%) 6 (12%) Ectopic Parathyroid Gland 1 (2%) Hemorrhage 1 (2%) Hyperplasia, Lymphoid 5 (9%) 10 (18%) 6 (11%) 2 (4%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (58) (60) (59) (60) Dilatation 1 (2%) 2 (3%) Hyperplasia 2 (3%) 1 (2%) 1 (2%) 2 (3%) Skin (60) (60) (59) (60) Inflammation, Chronic 6 (10%) 4 (7%) Inflammation, Chronic Active 4 (7%) 2 (3%) Ulcer 1 (2%) Epithelium, Hyperplasia 1 (2%) 2 (3%) 2 (3%) Sebaceous Gland, Hyperplasia, Focal 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (60) (60) (59) (60) Developmental Malformation 1 (2%) Dysplasia 24 (40%) 18 (30%) 25 (42%) 28 (47%) Hyperostosis 1 (2%) Maxilla, Fracture 1 (2%) Skeletal Muscle (3) (1) (1) Hemorrhage 1 (100%) Proliferation Connective Tissue 1 (33%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (59) (60) (59) (60) Compression 1 (2%) 1 (2%) 4 (7%) 2 (3%) Hemorrhage 2 (3%) 1 (2%) Mineralization 45 (76%) 26 (43%) 31 (53%) 27 (45%) Meninges, Inflammation, Chronic Active 1 (2%) Spinal Cord (1) Inflammation, Chronic 1 (100%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 6 NTP Experiment-Test: 05185-04 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: 11:28:48 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE CONTROL 37.5 PPM 75 PPM 150 PPM ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Larynx (60) (58) (59) (59) Artery, Inflammation, Chronic 1 (2%) Lung (60) (60) (59) (60) Infiltration Cellular, Lymphocyte 28 (47%) 14 (23%) 11 (19%) 23 (38%) Inflammation, Chronic Active 3 (5%) 3 (5%) 1 (2%) Leukocytosis 1 (2%) Alveolar Epithelium, Hyperplasia, Focal 2 (3%) 10 (17%) 8 (13%) Alveolus, Infiltration Cellular, Histiocyte 1 (2%) 1 (2%) 2 (3%) Artery, Inflammation, Chronic 1 (2%) Fat, Mediastinum, Necrosis 1 (2%) Nose (60) (60) (59) (60) Exudate 1 (2%) Exudate, Serous 1 (2%) 1 (2%) 2 (3%) 23 (38%) Inflammation, Chronic Active 6 (10%) 10 (17%) 12 (20%) 12 (20%) Olfactory Epithelium, Atrophy 1 (2%) 16 (27%) Olfactory Epithelium, Degeneration, Hyaline 4 (7%) 3 (5%) 5 (8%) 3 (5%) Olfactory Epithelium, Metaplasia 6 (10%) 2 (3%) 2 (3%) Olfactory Epithelium, Metaplasia, Squamous 1 (2%) 1 (2%) Respiratory Epithelium, Degeneration, Hyaline 19 (32%) 26 (43%) 14 (24%) 19 (32%) Respiratory Epithelium, Hyperplasia 6 (10%) 3 (5%) 4 (7%) 1 (2%) Respiratory Epithelium, Metaplasia, Squamous 4 (7%) 5 (8%) 6 (10%) Respiratory Epithelium, Ulcer 3 (5%) 4 (7%) 3 (5%) 3 (5%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (1) Phthisis Bulbi 1 (100%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (60) (60) (59) (60) Amyloid Deposition 1 (2%) Cyst 1 (2%) Glomerulosclerosis 1 (2%) Hydronephrosis 1 (2%) 1 (2%) Infarct 1 (2%) Infiltration Cellular, Lymphocyte 35 (58%) 19 (32%) 19 (32%) 31 (52%) Nephropathy 2 (3%) 1 (2%) Renal Tubule, Degeneration, Hyaline 1 (2%) Renal Tubule, Dilatation 2 (3%) 1 (2%) 2 (3%) 1 (2%) Renal Tubule, Hyperplasia, Focal 1 (2%) 1 (2%) Renal Tubule, Pigmentation 1 (2%) Renal Tubule, Regeneration 1 (2%) 1 (2%) Urinary Bladder (58) (59) (57) (57) a Number of animals examined microscopically at site and number of animals with lesion Page 7 NTP Experiment-Test: 05185-04 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: 11:28:48 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE CONTROL 37.5 PPM 75 PPM 150 PPM ____________________________________________________________________________________________________________________________________ URINARY SYSTEM - CONT Dilatation 1 (2%) Infiltration Cellular, Lymphocyte 38 (66%) 40 (68%) 24 (42%) 34 (60%) a Number of animals examined microscopically at site and number of animals with lesion Page 8 NTP Experiment-Test: 05185-04 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: 11:28:48 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE CONTROL 37.5 PPM 75 PPM 150 PPM ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 60 60 60 60 Scheduled Sacrifice 10 10 10 7 Early Deaths Natural Death 10 8 11 17 Accidently Killed 2 2 Moribund Sacrifice 1 7 4 4 Survivors Terminal Sacrifice 37 35 35 30 Animals Examined Microscopically 60 60 60 60 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Gallbladder (51) (50) (51) (53) Inflammation, Chronic Active 1 (2%) Intestine Large, Cecum (54) (55) (55) (50) Hyperplasia, Lymphoid 2 (4%) Intestine Small, Duodenum (53) (55) (55) (50) Proliferation Connective Tissue 1 (2%) Intestine Small, Jejunum (52) (55) (56) (50) Hyperplasia, Lymphoid 1 (2%) Inflammation, Chronic Active 1 (2%) Liver (60) (60) (60) (60) Abscess 1 (2%) Angiectasis 1 (2%) 1 (2%) Basophilic Focus 3 (5%) 2 (3%) 2 (3%) 2 (3%) Clear Cell Focus 2 (3%) 3 (5%) 3 (5%) Cytologic Alterations 3 (5%) 2 (3%) 2 (3%) Developmental Malformation 1 (2%) Eosinophilic Focus 1 (2%) 1 (2%) Fatty Change, Focal 1 (2%) 1 (2%) Hematopoietic Cell Proliferation 1 (2%) 1 (2%) 1 (2%) Hyperplasia 1 (2%) Infarct 2 (3%) 2 (3%) 3 (5%) 2 (3%) Inflammation, Chronic 1 (2%) 5 (8%) Inflammation, Chronic Active 1 (2%) 1 (2%) Mixed Cell Focus 5 (8%) 1 (2%) 1 (2%) Necrosis 1 (2%) 3 (5%) 3 (5%) 4 (7%) Proliferation Connective Tissue 1 (2%) 1 (2%) Syncytial Alteration 12 (20%) 14 (23%) 16 (27%) 11 (18%) Vacuolization Cytoplasmic 1 (2%) Bile Duct, Cyst 2 (3%) Bile Duct, Hyperplasia 1 (2%) 1 (2%) Centrilobular, Fatty Change 5 (8%) 6 (10%) 4 (7%) 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 9 NTP Experiment-Test: 05185-04 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: 11:28:48 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE CONTROL 37.5 PPM 75 PPM 150 PPM ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Centrilobular, Necrosis 2 (3%) Hepatocyte, Necrosis 1 (2%) Midzonal, Fatty Change 1 (2%) Periportal, Vacuolization Cytoplasmic 1 (2%) Mesentery (1) (5) (2) Artery, Inflammation, Chronic Active 1 (20%) Fat, Necrosis 1 (100%) 2 (40%) 2 (100%) Pancreas (60) (59) (60) (56) Inflammation, Chronic 3 (5%) 3 (5%) Inflammation, Chronic Active 1 (2%) Proliferation Connective Tissue 1 (2%) Acinus, Atrophy 1 (2%) 1 (2%) 1 (2%) 1 (2%) Duct, Cyst 1 (2%) Salivary Glands (60) (60) (60) (60) Inflammation, Chronic 36 (60%) 33 (55%) 29 (48%) 29 (48%) Stomach, Glandular (59) (59) (59) (56) Dysplasia 1 (2%) Necrosis 1 (2%) 1 (2%) 2 (4%) Ulcer 1 (2%) Tooth (3) (1) (1) Dysplasia 1 (33%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (60) (60) (60) (60) Cardiomyopathy 1 (2%) Degeneration 1 (2%) Mineralization 1 (2%) Thrombosis 1 (2%) Artery, Inflammation, Chronic Active 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (59) (59) (58) (58) Cyst 3 (5%) 1 (2%) Hyperplasia 1 (2%) Hypertrophy, Focal 6 (10%) 16 (27%) 10 (17%) 9 (16%) Capsule, Accessory Adrenal Cortical Nodule 2 (3%) 1 (2%) Subcapsular, Hyperplasia 33 (56%) 26 (44%) 18 (31%) 24 (41%) Adrenal Medulla (59) (59) (58) (58) Hyperplasia, Focal 2 (3%) Islets, Pancreatic (5) (3) (9) (1) Hyperplasia, Focal 3 (60%) 3 (100%) 7 (78%) 1 (100%) Pituitary Gland (56) (56) (54) (54) Pars Distalis, Cyst 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 10 NTP Experiment-Test: 05185-04 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: 11:28:48 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE CONTROL 37.5 PPM 75 PPM 150 PPM ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM - CONT Pars Distalis, Hyperplasia 1 (2%) 1 (2%) Pars Distalis, Hyperplasia, Focal 1 (2%) 1 (2%) Thyroid Gland (60) (60) (60) (60) Ultimobranchial Cyst 1 (2%) Follicular Cell, Hyperplasia 1 (2%) Follicular Cell, Hyperplasia, Focal 8 (13%) 17 (28%) 12 (20%) 20 (33%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Epididymis (60) (60) (60) (60) Inflammation, Chronic Active 1 (2%) 2 (3%) 3 (5%) 8 (13%) Spermatocele 1 (2%) Penis (1) (1) (1) (5) Congestion 1 (20%) Inflammation, Chronic Active 1 (100%) 1 (100%) 3 (60%) Preputial Gland (19) (22) (18) (14) Abscess 3 (14%) 2 (11%) 1 (7%) Dilatation 16 (84%) 14 (64%) 17 (94%) 11 (79%) Inflammation, Chronic Active 6 (32%) 6 (27%) 5 (28%) 4 (29%) Prostate (60) (59) (59) (60) Hyperplasia, Focal 1 (2%) Inflammation, Acute 1 (2%) 2 (3%) Inflammation, Chronic Active 1 (2%) 1 (2%) 4 (7%) 3 (5%) Seminal Vesicle (60) (60) (60) (60) Dilatation 4 (7%) 7 (12%) 12 (20%) 3 (5%) Hyperplasia 1 (2%) Inflammation, Acute 1 (2%) Inflammation, Chronic Active 1 (2%) 1 (2%) Testes (60) (60) (60) (60) Mineralization 1 (2%) Spermatocele 1 (2%) Seminiferous Tubule, Degeneration 2 (3%) 1 (2%) Tunic, Inflammation, Chronic 1 (2%) Tunic, Proliferation Connective Tissue 1 (2%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 11 NTP Experiment-Test: 05185-04 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: 11:28:48 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE CONTROL 37.5 PPM 75 PPM 150 PPM ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (60) (60) (59) (59) Infarct 1 (2%) Myeloid Cell, Hyperplasia 3 (5%) 5 (8%) 7 (12%) 9 (15%) Lymph Node (1) (5) (5) (5) Iliac, Infiltration Cellular, Histiocyte 1 (20%) Iliac, Inflammation, Chronic Active 1 (20%) Inguinal, Hyperplasia, Lymphoid 2 (40%) Inguinal, Inflammation, Chronic Active 1 (20%) Inguinal, Pigmentation 1 (20%) Lumbar, Hemorrhage 1 (20%) Lumbar, Hyperplasia, Histiocytic 1 (20%) Lumbar, Hyperplasia, Lymphoid 1 (20%) 1 (20%) Lumbar, Hyperplasia, Plasma Cell 1 (20%) Renal, Hyperplasia, Plasma Cell 1 (20%) 1 (20%) Lymph Node, Bronchial (33) (45) (26) (39) Hemorrhage 1 (2%) Hyperplasia, Lymphoid 1 (2%) 1 (4%) 1 (3%) Infiltration Cellular, Histiocyte 1 (3%) Inflammation, Chronic Active 1 (4%) Lymph Node, Mandibular (49) (59) (60) (55) Hemorrhage 1 (2%) Hyperplasia, Lymphoid 1 (2%) 1 (2%) 1 (2%) Pigmentation, Hemosiderin 1 (2%) Lymph Node, Mesenteric (57) (57) (57) (56) Angiectasis 1 (2%) Hematopoietic Cell Proliferation 1 (2%) 1 (2%) Hemorrhage 2 (4%) 4 (7%) 5 (9%) 6 (11%) Hyperplasia, Lymphoid 3 (5%) 1 (2%) 1 (2%) Hyperplasia, Plasma Cell 2 (4%) Lymph Node, Mediastinal (48) (47) (48) (46) Hemorrhage 1 (2%) 1 (2%) 1 (2%) Hyperplasia, Lymphoid 2 (4%) Hyperplasia, Plasma Cell 1 (2%) Spleen (60) (60) (59) (58) Fibrosis 1 (2%) Hematopoietic Cell Proliferation 59 (98%) 53 (88%) 57 (97%) 55 (95%) Hematopoietic Cell Proliferation Granulocytic 1 (2%) 2 (3%) Hyperplasia, Lymphoid 2 (3%) Pigmentation, Hemosiderin 34 (57%) 26 (43%) 55 (93%) 56 (97%) Lymphoid Follicle, Atrophy 2 (3%) Thymus (55) (56) (48) (50) Atrophy 13 (24%) 12 (21%) 7 (15%) 9 (18%) Cyst 1 (2%) Ectopic Parathyroid Gland 1 (2%) Hyperplasia, Lymphoid 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 12 NTP Experiment-Test: 05185-04 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: 11:28:48 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE CONTROL 37.5 PPM 75 PPM 150 PPM ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Skin (60) (60) (59) (59) Inflammation, Chronic 1 (2%) 2 (3%) Inflammation, Chronic Active 3 (5%) 2 (3%) 3 (5%) Ulcer 2 (3%) 2 (3%) Epithelium, Hyperplasia 1 (2%) 1 (2%) Fat, Necrosis 1 (2%) Hair Follicle, Atrophy 1 (2%) Prepuce, Inflammation, Chronic Active 1 (2%) 1 (2%) 1 (2%) Prepuce, Ulcer 1 (2%) Subcutaneous Tissue, Edema 1 (2%) Subcutaneous Tissue, Granuloma 1 (2%) Subcutaneous Tissue, Hemorrhage 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (60) (60) (60) (60) Developmental Malformation 1 (2%) Dysplasia 1 (2%) Fracture 1 (2%) Hyperostosis 1 (2%) Cartilage, Degeneration 1 (2%) Maxilla, Callus 1 (2%) Maxilla, Fracture 2 (3%) Skeletal Muscle (1) (1) Inflammation, Chronic Active 1 (100%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (60) (60) (60) (60) Mineralization 41 (68%) 36 (60%) 31 (52%) 24 (40%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Larynx (60) (60) (59) (57) Inflammation, Acute 1 (2%) Inflammation, Chronic Active 1 (2%) Lung (60) (60) (59) (60) Congestion 1 (2%) Infiltration Cellular, Lymphocyte 1 (2%) 3 (5%) 2 (3%) 3 (5%) Inflammation, Chronic Active 3 (5%) Leukocytosis 1 (2%) Alveolar Epithelium, Hyperplasia, Focal 1 (2%) 4 (7%) 7 (12%) 13 (22%) a Number of animals examined microscopically at site and number of animals with lesion Page 13 NTP Experiment-Test: 05185-04 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: 11:28:48 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE CONTROL 37.5 PPM 75 PPM 150 PPM ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM - CONT Alveolus, Infiltration Cellular, Histiocyte 1 (2%) 2 (3%) 2 (3%) Nose (60) (60) (60) (60) Exudate 1 (2%) Exudate, Serous 2 (3%) Inflammation, Chronic Active 8 (13%) 8 (13%) 7 (12%) 10 (17%) Olfactory Epithelium, Atrophy 1 (2%) 1 (2%) Olfactory Epithelium, Degeneration, Hyaline 4 (7%) 2 (3%) 2 (3%) Olfactory Epithelium, Metaplasia 3 (5%) 1 (2%) 3 (5%) 1 (2%) Respiratory Epithelium, Degeneration, Hyaline 4 (7%) 3 (5%) 3 (5%) 3 (5%) Respiratory Epithelium, Hyperplasia 13 (22%) 20 (33%) 19 (32%) 8 (13%) Respiratory Epithelium, Metaplasia, Squamous 3 (5%) 3 (5%) Respiratory Epithelium, Ulcer 2 (3%) 1 (2%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (1) (2) Phthisis Bulbi 1 (100%) 1 (50%) Cornea, Inflammation, Chronic Active 1 (50%) Lens, Cataract 1 (50%) Harderian Gland (5) (1) (3) (6) Inflammation, Chronic Active 1 (100%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (60) (60) (60) (60) Abscess 1 (2%) Amyloid Deposition 1 (2%) Cyst 2 (3%) 1 (2%) 2 (3%) 2 (3%) Hydronephrosis 2 (3%) 2 (3%) 5 (8%) Infarct 2 (3%) 1 (2%) Infiltration Cellular, Lymphocyte 17 (28%) 18 (30%) 13 (22%) 23 (38%) Inflammation, Acute 1 (2%) 2 (3%) Inflammation, Chronic Active 1 (2%) 3 (5%) 5 (8%) 6 (10%) Metaplasia, Osseous 1 (2%) 1 (2%) Mineralization 1 (2%) Nephropathy 1 (2%) 1 (2%) Artery, Inflammation, Chronic Active 1 (2%) Renal Tubule, Dilatation 1 (2%) 3 (5%) 6 (10%) Renal Tubule, Hyperplasia, Focal 1 (2%) 2 (3%) 2 (3%) Renal Tubule, Regeneration 12 (20%) 6 (10%) 5 (8%) 4 (7%) Urinary Bladder (60) (58) (59) (57) Dilatation 7 (12%) 7 (12%) 14 (24%) 9 (16%) Infiltration Cellular, Lymphocyte 2 (3%) 4 (7%) 1 (2%) 5 (9%) Inflammation, Acute 1 (2%) 1 (2%) Inflammation, Chronic Active 2 (3%) 3 (5%) 5 (8%) 8 (14%) a Number of animals examined microscopically at site and number of animals with lesion Page 14 NTP Experiment-Test: 05185-04 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: 11:28:48 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE CONTROL 37.5 PPM 75 PPM 150 PPM ____________________________________________________________________________________________________________________________________ URINARY SYSTEM - CONT Transitional Epithelium, Hyperplasia 1 (2%) 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 15 ------------------------------------------------------------ ---------- END OF REPORT ---------- ------------------------------------------------------------