TDMS Study 88007-06 Pathology Tables
NTP Experiment-Test: 88007-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC SODIUM NITRITE Date: 05/13/99 Route: DOSED WATER Time: 09:34:16 2 YEAR CHRONIC MICE Facility: Battelle Columbus Laboratory Chemical CAS #: 7632-00-0 Lock Date: 03/20/98 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: 88007-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC SODIUM NITRITE Date: 05/13/99 Route: DOSED WATER Time: 09:34:16 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0.0% 0.075% 0.15% 0.30% ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 50 50 50 50 Early Deaths Moribund Sacrifice 1 7 2 4 Natural Death 9 9 11 5 Survivors Terminal Sacrifice 40 34 37 41 Animals Examined Microscopically 50 50 50 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Gallbladder (48) (50) (50) (49) Cyst 1 (2%) 1 (2%) Infiltration Cellular, Mononuclear Cell 3 (6%) 1 (2%) 4 (8%) Epithelium, Cytoplasmic Alteration 1 (2%) Epithelium, Hyperplasia 1 (2%) Intestine Small, Duodenum (50) (48) (50) (49) Epithelium, Inflammation, Chronic Active 1 (2%) Epithelium, Ulcer 1 (2%) Intestine Small, Jejunum (50) (50) (50) (50) Necrosis 1 (2%) Peyer's Patch, Hyperplasia, Lymphoid 1 (2%) Intestine Small, Ileum (49) (49) (50) (50) Inflammation, Chronic Active 1 (2%) Liver (50) (50) (50) (50) Angiectasis 2 (4%) Basophilic Focus 3 (6%) 4 (8%) 3 (6%) 1 (2%) Clear Cell Focus 2 (4%) 3 (6%) 3 (6%) 2 (4%) Congestion 1 (2%) Eosinophilic Focus 7 (14%) 3 (6%) 4 (8%) 5 (10%) Hematopoietic Cell Proliferation 2 (4%) 5 (10%) 3 (6%) 4 (8%) Hemorrhage 1 (2%) Infiltration Cellular, Mononuclear Cell 30 (60%) 32 (64%) 29 (58%) 35 (70%) Inflammation, Chronic Active 36 (72%) 35 (70%) 30 (60%) 35 (70%) Mineralization 1 (2%) 1 (2%) 1 (2%) Mixed Cell Focus 3 (6%) 1 (2%) Necrosis 5 (10%) 4 (8%) 3 (6%) 2 (4%) Pigmentation 12 (24%) 17 (34%) 16 (32%) 18 (36%) Thrombosis 1 (2%) Vacuolization Cytoplasmic 10 (20%) 17 (34%) 12 (24%) 13 (26%) Bile Duct, Cyst 1 (2%) Bile Duct, Hyperplasia 1 (2%) 1 (2%) 1 (2%) Centrilobular, Necrosis 2 (4%) Centrilobular, Vacuolization Cytoplasmic 1 (2%) Hepatocyte, Centrilobular, Hypertrophy 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion NTP Experiment-Test: 88007-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC SODIUM NITRITE Date: 05/13/99 Route: DOSED WATER Time: 09:34:16 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0.0% 0.075% 0.15% 0.30% ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Mesentery (14) (19) (17) (13) Congestion 1 (5%) Hemorrhage 1 (6%) Infiltration Cellular, Mononuclear Cell 1 (8%) Inflammation, Chronic Active 1 (5%) Inflammation, Granulomatous 1 (7%) Pigmentation, Hemosiderin 1 (6%) Thrombosis 1 (5%) Artery, Inflammation, Chronic Active 1 (8%) Fat, Necrosis 10 (71%) 7 (37%) 10 (59%) 11 (85%) Oral Mucosa (1) (2) (3) Gingival, Foreign Body 1 (100%) 2 (100%) 3 (100%) Gingival, Inflammation, Chronic Active 1 (100%) 2 (100%) 2 (67%) Pancreas (50) (50) (50) (50) Infiltration Cellular, Mononuclear Cell 14 (28%) 10 (20%) 7 (14%) 13 (26%) Inflammation, Chronic Active 1 (2%) Acinus, Atrophy 1 (2%) 1 (2%) Acinus, Hyperplasia 1 (2%) Acinus, Hypertrophy 1 (2%) Artery, Inflammation, Chronic Active 1 (2%) 1 (2%) Duct, Cyst 1 (2%) 1 (2%) Salivary Glands (49) (49) (48) (50) Atrophy 2 (4%) Infiltration Cellular, Mononuclear Cell 34 (69%) 36 (73%) 40 (83%) 35 (70%) Stomach, Forestomach (50) (50) (50) (50) Infiltration Cellular, Mononuclear Cell 1 (2%) Ulcer 1 (2%) 2 (4%) 2 (4%) Epithelium, Hyperkeratosis 1 (2%) Epithelium, Hyperplasia 2 (4%) 3 (6%) 3 (6%) 6 (12%) Epithelium, Inflammation, Chronic Active 2 (4%) 3 (6%) 3 (6%) 1 (2%) Stomach, Glandular (50) (50) (50) (50) Mineralization 1 (2%) Epithelium, Hyperplasia 1 (2%) 1 (2%) Epithelium, Necrosis 1 (2%) Glands, Ectasia 19 (38%) 16 (32%) 10 (20%) 21 (42%) Glands, Necrosis 1 (2%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Blood Vessel (50) (50) (50) (50) Infiltration Cellular, Mononuclear Cell 1 (2%) Aorta, Inflammation, Chronic Active 1 (2%) Aorta, Mineralization 2 (4%) Pulmonary Artery, Mineralization 1 (2%) Heart (50) (50) (50) (50) Cardiomyopathy 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion NTP Experiment-Test: 88007-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC SODIUM NITRITE Date: 05/13/99 Route: DOSED WATER Time: 09:34:16 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0.0% 0.075% 0.15% 0.30% ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM - CONT Infiltration Cellular, Mononuclear Cell 1 (2%) Inflammation, Chronic Active 1 (2%) 1 (2%) Mineralization 1 (2%) 2 (4%) 1 (2%) Artery, Inflammation, Chronic Active 1 (2%) Artery, Mineralization 1 (2%) Valve, Inflammation, Chronic Active 2 (4%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (50) (50) (49) (50) Accessory Adrenal Cortical Nodule 1 (2%) 2 (4%) 1 (2%) 1 (2%) Degeneration, Fatty 1 (2%) 2 (4%) Hematopoietic Cell Proliferation 1 (2%) 2 (4%) 2 (4%) Inflammation, Chronic Active 1 (2%) Capsule, Hyperplasia 49 (98%) 50 (100%) 49 (100%) 49 (98%) Zona Fasciculata, Hyperplasia 1 (2%) 1 (2%) Zona Fasciculata, Hypertrophy 1 (2%) 1 (2%) Zona Glomerulosa, Hyperplasia 1 (2%) 1 (2%) Islets, Pancreatic (50) (50) (50) (50) Hyperplasia 45 (90%) 44 (88%) 40 (80%) 42 (84%) Pigmentation 1 (2%) Parathyroid Gland (33) (31) (31) (37) Cyst 1 (3%) Pituitary Gland (48) (47) (43) (48) Pars Distalis, Angiectasis 1 (2%) 3 (6%) 3 (6%) Pars Distalis, Cyst 2 (5%) 2 (4%) Pars Distalis, Hyperplasia 2 (4%) 3 (6%) 4 (9%) 6 (13%) Thyroid Gland (49) (49) (48) (49) Inflammation, Chronic Active 2 (4%) 1 (2%) 1 (2%) Follicle, Cyst 2 (4%) 1 (2%) Follicular Cell, Hyperplasia 1 (2%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM Peritoneum (1) (1) Inflammation, Granulomatous 1 (100%) ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Clitoral Gland (50) (49) (50) (48) Infiltration Cellular, Mononuclear Cell 7 (14%) 4 (8%) 13 (26%) 3 (6%) Inflammation, Chronic Active 1 (2%) 1 (2%) Inflammation, Suppurative 2 (4%) 2 (4%) Duct, Cyst 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion NTP Experiment-Test: 88007-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC SODIUM NITRITE Date: 05/13/99 Route: DOSED WATER Time: 09:34:16 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0.0% 0.075% 0.15% 0.30% ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM - CONT Ovary (47) (49) (50) (49) Angiectasis 1 (2%) Cyst 6 (13%) 9 (18%) 9 (18%) 7 (14%) Hemorrhage 2 (4%) 1 (2%) 1 (2%) 1 (2%) Hyperplasia, Adenomatous 1 (2%) Mineralization 3 (6%) 1 (2%) Pigmentation 1 (2%) Thrombosis 2 (4%) 1 (2%) 1 (2%) Uterus (50) (50) (50) (50) Hemorrhage 1 (2%) Hydrometra 32 (64%) 31 (62%) 33 (66%) 37 (74%) Infiltration Cellular, Mononuclear Cell 2 (4%) Inflammation, Suppurative 1 (2%) 2 (4%) Endometrium, Hyperplasia, Cystic 13 (26%) 10 (20%) 16 (32%) 18 (36%) Submucosa, Hyperplasia, Stromal 1 (2%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (50) (50) (50) (50) Atrophy 2 (4%) Hyperplasia 1 (2%) Myelofibrosis 2 (4%) Myeloid Cell, Hyperplasia 2 (4%) 3 (6%) 1 (2%) 3 (6%) Lymph Node (7) (7) (8) (4) Inflammation, Granulomatous 1 (25%) Inguinal, Hyperplasia, Lymphoid 1 (13%) Lumbar, Hyperplasia, Lymphoid 1 (25%) Mediastinal, Hematopoietic Cell Proliferation 1 (25%) Mediastinal, Hyperplasia, Lymphoid 3 (38%) 1 (25%) Mediastinal, Pigmentation, Hemosiderin 1 (14%) Renal, Ectasia 1 (14%) 1 (13%) Renal, Hemorrhage 1 (14%) 1 (13%) Lymph Node, Mandibular (47) (46) (48) (48) Hematopoietic Cell Proliferation 1 (2%) Hyperplasia, Lymphoid 1 (2%) 5 (10%) 5 (10%) Hyperplasia, Plasma Cell 1 (2%) 1 (2%) Lymph Node, Mesenteric (50) (49) (47) (49) Ectasia 1 (2%) 1 (2%) 2 (4%) Fibrosis 1 (2%) Hematopoietic Cell Proliferation 1 (2%) Hyperplasia, Lymphoid 1 (2%) 2 (4%) Inflammation, Granulomatous 1 (2%) Spleen (49) (50) (50) (50) Hematopoietic Cell Proliferation 37 (76%) 39 (78%) 35 (70%) 39 (78%) Hyperplasia, Lymphoid 4 (8%) 3 (6%) 4 (8%) 1 (2%) Metaplasia, Osseous 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion NTP Experiment-Test: 88007-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC SODIUM NITRITE Date: 05/13/99 Route: DOSED WATER Time: 09:34:16 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0.0% 0.075% 0.15% 0.30% ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - CONT Capsule, Inflammation, Chronic Active 1 (2%) Thymus (46) (47) (44) (46) Cyst 10 (22%) 12 (26%) 17 (39%) 16 (35%) Ectopic Parathyroid Gland 1 (2%) 5 (11%) 3 (7%) 2 (4%) Hyperplasia, Lymphoid 1 (2%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (49) (50) (49) (50) Hyperplasia, Cystic 1 (2%) 3 (6%) 1 (2%) Skin (50) (50) (50) (50) Inflammation, Chronic Active 1 (2%) 3 (6%) 2 (4%) Ulcer 1 (2%) 1 (2%) 1 (2%) Epidermis, Hyperplasia 1 (2%) 1 (2%) Subcutaneous Tissue, Fibrosis 2 (4%) Subcutaneous Tissue, Infiltration Cellular, Mononuclear Cell 2 (4%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (50) (50) (50) (50) Periosteum, Synovial Tissue, Inflammation, Chronic Active 1 (2%) Skeletal Muscle (3) (2) (1) (3) Artery, Inflammation, Chronic Active 1 (33%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (50) (49) (50) Degeneration 1 (2%) Hemorrhage 1 (2%) 1 (2%) Peripheral Nerve (2) Sciatic, Inflammation, Chronic Active 1 (50%) Spinal Cord (2) Demyelination 2 (100%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (50) (50) (50) Hemorrhage 1 (2%) Infiltration Cellular, Mononuclear Cell 1 (2%) 2 (4%) 1 (2%) Inflammation, Chronic Active 2 (4%) 3 (6%) 2 (4%) Metaplasia, Osseous 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion NTP Experiment-Test: 88007-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC SODIUM NITRITE Date: 05/13/99 Route: DOSED WATER Time: 09:34:16 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0.0% 0.075% 0.15% 0.30% ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM - CONT Mineralization 1 (2%) 1 (2%) Alveolar Epithelium, Hyperplasia 1 (2%) 4 (8%) 3 (6%) Alveolus, Infiltration Cellular, Histiocyte 3 (6%) 2 (4%) 2 (4%) Bronchus, Mineralization 1 (2%) Interstitium, Inflammation, Chronic Active 1 (2%) Vein, Mineralization 1 (2%) 1 (2%) 1 (2%) Nose (50) (49) (50) (50) Foreign Body 1 (2%) Inflammation, Chronic Active 1 (2%) Nasolacrimal Duct, Inflammation, Suppurative 1 (2%) 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (1) Cataract 1 (100%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (50) (50) (50) Accumulation, Hyaline Droplet 1 (2%) Infarct 2 (4%) 4 (8%) 3 (6%) 6 (12%) Infiltration Cellular, Mononuclear Cell 35 (70%) 37 (74%) 34 (68%) 40 (80%) Infiltration Cellular, Plasma Cell 1 (2%) Inflammation, Suppurative 1 (2%) Mineralization 5 (10%) 8 (16%) 6 (12%) 4 (8%) Nephropathy 20 (40%) 17 (34%) 13 (26%) 20 (40%) Cortex, Cyst 1 (2%) Vein, Inflammation, Chronic Active 1 (2%) Urinary Bladder (50) (50) (50) (50) Infiltration Cellular, Mononuclear Cell 25 (50%) 29 (58%) 24 (48%) 25 (50%) Inflammation, Chronic Active 1 (2%) 1 (2%) Mineralization 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion NTP Experiment-Test: 88007-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC SODIUM NITRITE Date: 05/13/99 Route: DOSED WATER Time: 09:34:16 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0.0% 0.075% 0.15% 0.30% ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 50 50 50 50 Early Deaths Moribund Sacrifice 3 2 3 1 Natural Death 8 3 5 10 Survivors Terminal Sacrifice 39 45 42 39 Animals Examined Microscopically 50 50 50 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Gallbladder (50) (50) (49) (49) Cyst 1 (2%) Intestine Small, Duodenum (49) (50) (48) (49) Ectasia 2 (4%) 2 (4%) Intestine Small, Jejunum (50) (50) (50) (50) Inflammation, Chronic Active 1 (2%) Intussusception 1 (2%) Peyer's Patch, Hyperplasia, Lymphoid 2 (4%) Peyer's Patch, Inflammation, Granulomatous 1 (2%) Intestine Small, Ileum (50) (49) (50) (50) Parasite Metazoan 1 (2%) Liver (50) (50) (50) (50) Basophilic Focus 3 (6%) 3 (6%) 1 (2%) Clear Cell Focus 4 (8%) 6 (12%) 10 (20%) 7 (14%) Eosinophilic Focus 12 (24%) 14 (28%) 14 (28%) 7 (14%) Fibrosis 1 (2%) Hematopoietic Cell Proliferation 1 (2%) 1 (2%) Infarct 2 (4%) Infiltration Cellular, Mononuclear Cell 2 (4%) 3 (6%) 1 (2%) Inflammation, Chronic Active 25 (50%) 25 (50%) 31 (62%) 19 (38%) Mineralization 1 (2%) 1 (2%) 2 (4%) Mixed Cell Focus 6 (12%) 2 (4%) 7 (14%) 9 (18%) Necrosis 12 (24%) 4 (8%) 6 (12%) 2 (4%) Pigmentation 2 (4%) 2 (4%) 1 (2%) Vacuolization Cytoplasmic 3 (6%) 3 (6%) 1 (2%) Bile Duct, Cyst 1 (2%) Bile Duct, Hyperplasia 1 (2%) 1 (2%) 1 (2%) 2 (4%) Hepatocyte, Karyomegaly 1 (2%) Mesentery (7) (6) (7) (5) Infiltration Cellular, Mononuclear Cell 2 (29%) Inflammation, Granulomatous 2 (29%) 2 (29%) Mineralization 1 (14%) 1 (17%) Pigmentation 1 (17%) 1 (14%) Artery, Inflammation, Chronic Active 1 (17%) a Number of animals examined microscopically at site and number of animals with lesion NTP Experiment-Test: 88007-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC SODIUM NITRITE Date: 05/13/99 Route: DOSED WATER Time: 09:34:16 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0.0% 0.075% 0.15% 0.30% ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Fat, Necrosis 4 (57%) 4 (67%) 3 (43%) 2 (40%) Oral Mucosa (26) (27) (17) (19) Gingival, Foreign Body 26 (100%) 27 (100%) 17 (100%) 19 (100%) Gingival, Inflammation, Chronic Active 21 (81%) 22 (81%) 14 (82%) 11 (58%) Pancreas (49) (50) (50) (50) Fibrosis 1 (2%) Infiltration Cellular, Mononuclear Cell 2 (4%) 2 (4%) 3 (6%) 2 (4%) Inflammation, Chronic Active 1 (2%) Acinus, Atrophy 1 (2%) 1 (2%) Acinus, Hypertrophy 1 (2%) Artery, Inflammation, Chronic Active 1 (2%) Salivary Glands (50) (50) (50) (50) Atrophy 1 (2%) Infiltration Cellular, Mononuclear Cell 27 (54%) 28 (56%) 33 (66%) 32 (64%) Mineralization 1 (2%) 1 (2%) Stomach, Forestomach (50) (50) (50) (50) Ulcer 3 (6%) 1 (2%) 1 (2%) Epithelium, Hyperplasia 6 (12%) 1 (2%) 2 (4%) 3 (6%) Epithelium, Inflammation, Chronic Active 2 (4%) 2 (4%) 1 (2%) Stomach, Glandular (50) (50) (50) (50) Mineralization 1 (2%) Epithelium, Erosion 1 (2%) Epithelium, Hyperplasia 2 (4%) 10 (20%) Epithelium, Necrosis 1 (2%) Glands, Ectasia 12 (24%) 18 (36%) 16 (32%) 14 (28%) Tooth (5) (5) (4) (1) Malformation 5 (100%) 4 (80%) 3 (75%) 1 (100%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Blood Vessel (50) (50) (50) (50) Aorta, Inflammation, Chronic Active 1 (2%) Heart (50) (50) (50) (50) Cardiomyopathy 1 (2%) Inflammation, Chronic Active 1 (2%) Mineralization 3 (6%) 1 (2%) Artery, Inflammation, Chronic Active 2 (4%) Atrium, Thrombosis 1 (2%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (50) (50) (50) (50) Accessory Adrenal Cortical Nodule 2 (4%) 6 (12%) 4 (8%) Degeneration, Fatty 1 (2%) 1 (2%) Pigmentation 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion NTP Experiment-Test: 88007-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC SODIUM NITRITE Date: 05/13/99 Route: DOSED WATER Time: 09:34:16 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0.0% 0.075% 0.15% 0.30% ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM - CONT Capsule, Hyperplasia 46 (92%) 42 (84%) 40 (80%) 40 (80%) Zona Fasciculata, Hyperplasia 1 (2%) 1 (2%) Zona Fasciculata, Hypertrophy 18 (36%) 24 (48%) 14 (28%) 21 (42%) Adrenal Medulla (50) (50) (50) (50) Hyperplasia 1 (2%) Islets, Pancreatic (50) (50) (50) (50) Hyperplasia 46 (92%) 47 (94%) 49 (98%) 44 (88%) Parathyroid Gland (36) (48) (38) (41) Cyst 1 (3%) Pituitary Gland (49) (49) (47) (47) Pars Distalis, Cyst 3 (6%) 2 (4%) 2 (4%) 4 (9%) Pars Distalis, Hyperplasia 1 (2%) Thyroid Gland (50) (50) (50) (50) Inflammation, Chronic Active 1 (2%) Follicle, Cyst 4 (8%) 1 (2%) 1 (2%) 2 (4%) Follicular Cell, Hyperplasia 1 (2%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Coagulating Gland (1) Inflammation, Chronic Active 1 (100%) Epididymis (50) (50) (50) (50) Granuloma Sperm 1 (2%) 1 (2%) 1 (2%) Infiltration Cellular, Mononuclear Cell 21 (42%) 22 (44%) 25 (50%) 25 (50%) Infiltration Cellular, Mixed Cell 1 (2%) Inflammation, Chronic Active 1 (2%) Preputial Gland (50) (50) (49) (50) Atrophy 1 (2%) 1 (2%) Infiltration Cellular, Mononuclear Cell 27 (54%) 28 (56%) 29 (59%) 25 (50%) Inflammation, Chronic Active 7 (14%) 8 (16%) 4 (8%) 4 (8%) Inflammation, Suppurative 2 (4%) Duct, Cyst 33 (66%) 32 (64%) 33 (67%) 39 (78%) Prostate (50) (50) (49) (50) Infiltration Cellular, Mononuclear Cell 15 (30%) 22 (44%) 29 (59%) 28 (56%) Inflammation, Chronic Active 1 (2%) 2 (4%) 3 (6%) Inflammation, Suppurative 1 (2%) 1 (2%) Artery, Inflammation, Chronic Active 2 (4%) Seminal Vesicle (50) (50) (50) (50) Congestion 1 (2%) Dilatation 2 (4%) 2 (4%) Infiltration Cellular, Mononuclear Cell 1 (2%) 1 (2%) 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion NTP Experiment-Test: 88007-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC SODIUM NITRITE Date: 05/13/99 Route: DOSED WATER Time: 09:34:16 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0.0% 0.075% 0.15% 0.30% ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM - CONT Inflammation, Chronic Active 2 (4%) Inflammation, Suppurative 1 (2%) Bilateral, Dilatation 1 (2%) 1 (2%) 1 (2%) Testes (50) (50) (50) (50) Mineralization 2 (4%) Germinal Epithelium, Atrophy 1 (2%) 1 (2%) Germinal Epithelium, Necrosis 1 (2%) Interstitial Cell, Hyperplasia 2 (4%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (50) (50) (49) (50) Hemorrhage 1 (2%) Thrombosis 1 (2%) Myeloid Cell, Hyperplasia 1 (2%) 2 (4%) Lymph Node (1) (1) (3) (5) Lumbar, Hyperplasia, Plasma Cell 1 (33%) Mediastinal, Hemorrhage 1 (20%) Mediastinal, Inflammation, Granulomatous 1 (20%) Renal, Hyperplasia, Lymphoid 1 (100%) Renal, Hyperplasia, Plasma Cell 1 (33%) Lymph Node, Mandibular (47) (50) (47) (48) Hyperplasia, Lymphoid 2 (4%) 1 (2%) 1 (2%) Lymph Node, Mesenteric (49) (49) (48) (49) Ectasia 1 (2%) Hematopoietic Cell Proliferation 1 (2%) Hyperplasia, Plasma Cell 2 (4%) 1 (2%) Hyperplasia, Lymphocyte 1 (2%) 1 (2%) Infiltration Cellular, Eosinophil 1 (2%) Inflammation, Chronic Active 1 (2%) Inflammation, Granulomatous 1 (2%) 2 (4%) Spleen (50) (50) (50) (50) Hematopoietic Cell Proliferation 22 (44%) 11 (22%) 14 (28%) 20 (40%) Hyperplasia, Lymphoid 1 (2%) 1 (2%) Thymus (37) (39) (38) (42) Cyst 9 (24%) 14 (36%) 16 (42%) 9 (21%) Hemorrhage 1 (3%) Inflammation, Granulomatous 1 (3%) Necrosis 1 (3%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion NTP Experiment-Test: 88007-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC SODIUM NITRITE Date: 05/13/99 Route: DOSED WATER Time: 09:34:16 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0.0% 0.075% 0.15% 0.30% ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Skin (50) (50) (50) (50) Cyst Epithelial Inclusion 1 (2%) Inflammation, Chronic Active 4 (8%) 1 (2%) 1 (2%) 2 (4%) Ulcer 3 (6%) 1 (2%) 1 (2%) 2 (4%) Epidermis, Hyperplasia 2 (4%) 1 (2%) 1 (2%) Subcutaneous Tissue, Infiltration Cellular, Mononuclear Cell 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (50) (50) (49) (50) Cranium, Hyperostosis 1 (2%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (50) (50) (50) Neuron, Necrosis 2 (4%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (50) (50) (50) Hemorrhage 1 (2%) Inflammation, Chronic 1 (2%) Inflammation, Chronic Active 1 (2%) 1 (2%) 1 (2%) Mineralization 4 (8%) 3 (6%) Necrosis 2 (4%) Alveolar Epithelium, Hyperplasia 3 (6%) 2 (4%) 6 (12%) 9 (18%) Alveolus, Infiltration Cellular, Histiocyte 3 (6%) 1 (2%) 2 (4%) 3 (6%) Interstitium, Inflammation, Chronic Active 1 (2%) Mediastinum, Inflammation, Chronic Active 1 (2%) Mediastinum, Inflammation, Suppurative 1 (2%) Mediastinum, Pigmentation 1 (2%) Nose (50) (50) (49) (50) Foreign Body 2 (4%) 1 (2%) 3 (6%) 1 (2%) Inflammation, Chronic Active 1 (2%) 1 (2%) 2 (4%) 1 (2%) Inflammation, Suppurative 1 (2%) 1 (2%) Nasolacrimal Duct, Inflammation, Suppurative 1 (2%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion NTP Experiment-Test: 88007-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC SODIUM NITRITE Date: 05/13/99 Route: DOSED WATER Time: 09:34:16 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0.0% 0.075% 0.15% 0.30% ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (1) Atrophy 1 (100%) Harderian Gland (5) (4) (6) (1) Hyperplasia 1 (25%) Inflammation, Chronic 1 (25%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (50) (50) (50) Hydronephrosis 1 (2%) 1 (2%) Infarct 11 (22%) 10 (20%) 9 (18%) 13 (26%) Infiltration Cellular, Mononuclear Cell 42 (84%) 41 (82%) 41 (82%) 45 (90%) Infiltration Cellular, Plasma Cell 1 (2%) Inflammation, Chronic Active 2 (4%) 1 (2%) 1 (2%) Inflammation, Suppurative 1 (2%) 1 (2%) Metaplasia, Osseous 2 (4%) 3 (6%) Mineralization 48 (96%) 50 (100%) 48 (96%) 46 (92%) Necrosis 1 (2%) 1 (2%) Nephropathy 44 (88%) 49 (98%) 45 (90%) 42 (84%) Pigmentation 1 (2%) Artery, Inflammation, Chronic Active 2 (4%) 1 (2%) Cortex, Cyst 5 (10%) 9 (18%) 6 (12%) 4 (8%) Renal Tubule, Hypertrophy, Focal 1 (2%) Urinary Bladder (50) (50) (50) (49) Infiltration Cellular, Mononuclear Cell 6 (12%) 7 (14%) 16 (32%) 10 (20%) Inflammation, Suppurative 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion ------------------------------------------------------------ ---------- END OF REPORT ---------- ------------------------------------------------------------