TR 393 Rat Pathology Tables
INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) SODIUM FLUORIDE NTP Experiment-Test: 05131-01 Report: PEIRPT03 Study Type: CHRONIC Date: 09/17/94 Route: DOSED WATER Time: 03:55:26 Facility: Battelle Columbus Laboratory Chemical CAS #: 7681-49-4 Lock Date: None 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: 05131-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC SODIUM FLUORIDE Date: 09/17/94 Route: DOSED WATER Time: 03:55:26 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 PPM SPECIAL 25 PPM 100 PPM 175 PPM CONTROL ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 100 50 70 70 100 Scheduled Sacrifice 20 20 20 19 Early Deaths Natural Death 10 4 11 6 10 Moribund Sacrifice 11 7 8 10 17 Survivors Terminal Sacrifice 59 18 31 34 54 Special Control 21 Animals Examined Microscopically 100 32 70 70 100 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Small, Duodenum (100) (32) (60) (60) (100) Necrosis 1 (2%) Intestine Small, Jejunum (100) (32) (60) (60) (100) Inflammation, Chronic 1 (2%) Liver (100) (32) (60) (60) (100) Angiectasis 1 (1%) 1 (2%) Basophilic Focus 55 (55%) 13 (41%) 38 (63%) 33 (55%) 52 (52%) Clear Cell Focus 13 (13%) 1 (3%) 8 (13%) 9 (15%) 8 (8%) Congestion 1 (1%) 1 (2%) 2 (3%) Eosinophilic Focus 4 (4%) 1 (3%) 6 (10%) 7 (12%) 9 (9%) Hepatodiaphragmatic Nodule 8 (8%) 5 (16%) 8 (13%) 10 (17%) 15 (15%) Hepatodiaphragmatic Nodule, Multiple 1 (2%) 1 (1%) Hyperplasia 1 (1%) 2 (3%) 3 (5%) Inflammation, Chronic Active 23 (23%) 11 (34%) 17 (28%) 16 (27%) 24 (24%) Mixed Cell Focus 1 (2%) 2 (2%) Vacuolization Cytoplasmic 11 (11%) 6 (19%) 8 (13%) 7 (12%) 19 (19%) Bile Duct, Hyperplasia 25 (25%) 12 (38%) 14 (23%) 18 (30%) 23 (23%) Centrilobular, Necrosis 1 (1%) 1 (2%) 1 (2%) Hepatocyte, Degeneration, Cystic 1 (2%) Mesentery (4) (1) (3) (2) (2) Inflammation, Chronic Active 1 (25%) Fat, Congestion, Acute 1 (50%) Fat, Inflammation, Chronic Active 3 (75%) 2 (67%) 2 (100%) Pancreas (100) (32) (60) (60) (99) Acinus, Atrophy 21 (21%) 6 (19%) 10 (17%) 7 (12%) 21 (21%) Acinus, Cytomegaly, Focal 1 (2%) Artery, Inflammation, Chronic Active 1 (1%) Pharynx (1) (2) (1) Hyperplasia, Squamous 1 (50%) Salivary Glands (100) (32) (60) (59) (97) Acinus, Atrophy 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 2 NTP Experiment-Test: 05131-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC SODIUM FLUORIDE Date: 09/17/94 Route: DOSED WATER Time: 03:55:26 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 PPM SPECIAL 25 PPM 100 PPM 175 PPM CONTROL ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Acinus, Cytomegaly 1 (1%) Stomach, Forestomach (100) (32) (60) (60) (100) Acanthosis 4 (4%) 1 (3%) 3 (5%) 2 (3%) 3 (3%) Inflammation, Chronic Active 1 (2%) 2 (2%) Ulcer 1 (1%) 3 (5%) 3 (5%) 6 (6%) Stomach, Glandular (100) (32) (60) (60) (100) Cyst Epithelial Inclusion 1 (1%) Erosion 1 (2%) Hyperplasia 1 (1%) Mineralization 1 (1%) Necrosis 2 (2%) 2 (6%) 1 (2%) 1 (2%) 3 (3%) Pigmentation 1 (2%) Pigmentation, Hemosiderin 1 (2%) 1 (2%) 1 (1%) Ulcer 1 (3%) 1 (2%) 1 (2%) 3 (3%) Tongue (1) (1) (1) Hyperplasia, Squamous 1 (100%) 1 (100%) 1 (100%) Tooth (98) (31) (70) (70) (100) Dentine, Dentine, Incisor, Incisor, Necrosis, Multifocal, Multifocal 1 (1%) Dentine, Incisor, Dysplasia 2 (6%) 8 (11%) 4 (6%) 10 (10%) Dentine, Incisor, Necrosis, Focal 5 (5%) 4 (6%) 4 (4%) Dentine, Incisor, Necrosis, Multifocal 54 (55%) 16 (52%) 34 (49%) 26 (37%) 53 (53%) Incisor, Odontoblast, Degeneration 2 (2%) Incisor, Ameloblast, Degeneration 1 (1%) 7 (7%) Peridontal Tissue, Incisor, Inflammation, Necrotizing 1 (1%) Peridontal Tissue, Incisor, Lower, Inflammation, Chronic, Suppurative 1 (1%) Peridontal Tissue, Molar, Inflammation, Suppurative 3 (3%) 2 (3%) 4 (4%) Peridontal Tissue, Molar, Lower, Inflammation, Chronic, Suppurative 20 (20%) 5 (16%) 7 (10%) 10 (14%) 21 (21%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (100) (32) (60) (60) (100) Degeneration, Chronic 69 (69%) 18 (56%) 46 (77%) 43 (72%) 69 (69%) Inflammation, Chronic Active 1 (1%) Thrombosis 1 (3%) 1 (2%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 3 NTP Experiment-Test: 05131-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC SODIUM FLUORIDE Date: 09/17/94 Route: DOSED WATER Time: 03:55:26 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 PPM SPECIAL 25 PPM 100 PPM 175 PPM CONTROL ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Gland, Cortex (100) (32) (60) (60) (100) Accessory Adrenal Cortical Nodule 1 (1%) 1 (2%) 1 (1%) Angiectasis 1 (2%) Congestion 1 (1%) Degeneration, Cystic 5 (5%) 1 (2%) 1 (2%) 3 (3%) Hyperplasia 17 (17%) 2 (6%) 13 (22%) 18 (30%) 15 (15%) Hypertrophy 3 (3%) 1 (3%) 5 (8%) 5 (8%) 10 (10%) Necrosis 1 (2%) Vacuolization Cytoplasmic, Focal 7 (7%) 1 (2%) 2 (3%) 7 (7%) Bilateral, Degeneration, Cystic 1 (2%) Bilateral, Hyperplasia 1 (1%) Adrenal Gland, Medulla (100) (32) (59) (60) (100) Angiectasis 1 (2%) Cyst 1 (1%) Hemorrhage 1 (1%) Hyperplasia 3 (3%) 3 (5%) 8 (13%) 6 (6%) Hypertrophy 1 (2%) Islets, Pancreatic (100) (32) (60) (60) (99) Hyperplasia 1 (1%) Pituitary Gland (99) (32) (60) (60) (100) Pars Distalis, Congestion 21 (21%) 1 (3%) 12 (20%) 17 (28%) 22 (22%) Pars Distalis, Cyst 20 (20%) 6 (19%) 23 (38%) 17 (28%) 30 (30%) Pars Distalis, Hemorrhage 1 (1%) 1 (3%) 2 (3%) 5 (5%) Pars Distalis, Hyperplasia 21 (21%) 7 (22%) 13 (22%) 10 (17%) 19 (19%) Pars Intermedia, Congestion 1 (2%) Pars Intermedia, Cyst 2 (2%) 1 (2%) 4 (4%) Pars Intermedia, Hyperplasia 1 (1%) 1 (2%) Rathke's Cleft, Cyst 1 (1%) Thyroid Gland (100) (32) (60) (60) (100) C-Cell, Hyperplasia 9 (9%) 1 (3%) 6 (10%) 9 (15%) 8 (8%) Follicle, Cyst 1 (3%) 2 (2%) Follicular Cell, Hyperplasia 1 (3%) 1 (2%) 4 (4%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Clitoral Gland (98) (32) (58) (59) (98) Hyperplasia 1 (1%) Hyperplasia, Glandular 4 (4%) 1 (3%) 7 (12%) 6 (10%) 6 (6%) Inflammation, Chronic Active 14 (14%) 2 (6%) 10 (17%) 11 (19%) 18 (18%) Duct, Cyst 8 (8%) 3 (5%) 3 (5%) 5 (5%) a Number of animals examined microscopically at site and number of animals with lesion Page 4 NTP Experiment-Test: 05131-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC SODIUM FLUORIDE Date: 09/17/94 Route: DOSED WATER Time: 03:55:26 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 PPM SPECIAL 25 PPM 100 PPM 175 PPM CONTROL ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM - CONT Duct, Hyperplasia, Squamous 2 (2%) Ovary (100) (32) (60) (60) (100) Infiltration Cellular, Lymphocyte 1 (2%) Bilateral, Periovarian Tissue, Cyst 1 (1%) Follicle, Cyst 1 (1%) 2 (6%) 1 (2%) 1 (1%) Periovarian Tissue, Cyst 2 (2%) 6 (10%) 3 (5%) 4 (4%) Periovarian Tissue, Hemorrhage 1 (2%) Uterus (100) (32) (60) (60) (100) Hemorrhage 1 (1%) Infarct, Chronic 1 (2%) Cervix, Cyst 2 (2%) 1 (3%) 1 (2%) 2 (3%) 4 (4%) Endometrium, Hyperplasia, Cystic, Glandular 12 (12%) 4 (13%) 13 (22%) 11 (18%) 13 (13%) Lumen, Hemorrhage 2 (3%) Vagina (3) (2) Exudate 1 (33%) 1 (50%) Prolapse 1 (33%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (99) (32) (60) (60) (100) Femoral, Atrophy 1 (2%) Femoral, Myelofibrosis 1 (2%) 1 (1%) Lymph Node (100) (32) (60) (60) (100) Mediastinal, Angiectasis 1 (3%) Mediastinal, Congestion 1 (1%) 1 (2%) Renal, Angiectasis 1 (3%) Renal, Pigmentation, Hemosiderin 1 (3%) Lymph Node, Mandibular (100) (32) (60) (59) (100) Congestion 3 (5%) Necrosis 1 (2%) Lymph Node, Mesenteric (100) (31) (60) (59) (100) Angiectasis 1 (1%) Infiltration Cellular, Histiocyte 1 (1%) 1 (2%) Inflammation, Chronic Active 1 (1%) Spleen (100) (32) (60) (60) (100) Depletion Lymphoid 1 (2%) 1 (2%) 2 (2%) Fibrosis 2 (2%) 1 (3%) 1 (2%) 2 (3%) Hematopoietic Cell Proliferation 1 (1%) 1 (2%) 1 (1%) Hyperplasia, Lymphoid, Nodular 1 (1%) Hyperplasia, Reticulum Cell 2 (2%) 1 (2%) Infiltration Cellular, Lipocyte 1 (1%) Inflammation, Granulomatous 1 (1%) Necrosis 2 (2%) 1 (2%) Thrombosis 1 (1%) Capsule, Fibrosis 1 (2%) 1 (1%) Red Pulp, Atrophy 1 (2%) 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 5 NTP Experiment-Test: 05131-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC SODIUM FLUORIDE Date: 09/17/94 Route: DOSED WATER Time: 03:55:26 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 PPM SPECIAL 25 PPM 100 PPM 175 PPM CONTROL ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - CONT Thymus (90) (29) (58) (56) (95) Depletion Lymphoid 62 (69%) 10 (34%) 42 (72%) 43 (77%) 73 (77%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (99) (31) (60) (60) (99) Hyperplasia, Cystic 81 (82%) 24 (77%) 51 (85%) 52 (87%) 77 (78%) Mineralization 1 (1%) Skin (99) (32) (60) (59) (100) Ulcer 1 (1%) 1 (2%) Subcutaneous Tissue, Inflammation, Chronic Active 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (100) (32) (70) (70) (100) Cranium, Osteosclerosis 1 (1%) Femur, Fibrous Osteodystrophy 1 (1%) Femur, Osteosclerosis 1 (1%) Humerus, Fibrous Osteodystrophy 1 (1%) Humerus, Osteosclerosis 4 (4%) 4 (13%) 5 (7%) 4 (6%) 11 (11%) Joint, Cartilage, Tibia, Degeneration 1 (1%) Mandible, Fibrous Osteodystrophy 1 (1%) Maxilla, Fibrous Osteodystrophy 1 (3%) Maxilla, Osteosclerosis 2 (3%) 3 (3%) Thoracic, Vertebra, Fibrous Osteodystrophy 1 (1%) Thoracic, Vertebra, Osteosclerosis 5 (5%) 1 (3%) 7 (10%) 5 (7%) 15 (15%) Tibia, Fibrous Osteodystrophy 1 (1%) Tibia, Osteosclerosis 6 (6%) 2 (6%) 11 (16%) 9 (13%) 15 (15%) Vertebra, Osteosclerosis 1 (1%) Skeletal Muscle (1) Necrosis 1 (100%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (100) (32) (60) (60) (100) Compression 6 (6%) 2 (6%) 4 (7%) 7 (12%) 10 (10%) Hemorrhage 1 (1%) 1 (1%) Hydrocephalus 5 (5%) 1 (3%) 3 (5%) 5 (8%) 6 (6%) Necrosis 1 (1%) Spinal Cord (1) Myelin, Degeneration 1 (100%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 6 NTP Experiment-Test: 05131-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC SODIUM FLUORIDE Date: 09/17/94 Route: DOSED WATER Time: 03:55:26 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 PPM SPECIAL 25 PPM 100 PPM 175 PPM CONTROL ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (100) (32) (60) (60) (100) Foreign Body 1 (1%) Inflammation, Chronic Active 1 (1%) 1 (2%) 1 (2%) Mineralization 1 (2%) Alveolar Epithelium, Hyperplasia 3 (3%) 1 (3%) 4 (7%) 2 (3%) 5 (5%) Alveolar Epithelium, Hyperplasia, Focal 1 (2%) Nose (100) (32) (60) (60) (100) Inflammation, Chronic Active 1 (1%) 1 (2%) 1 (2%) 1 (1%) Metaplasia, Squamous 1 (1%) 2 (3%) 1 (2%) Mucosa, Inflammation, Acute 2 (2%) 1 (3%) 1 (2%) 1 (1%) Mucosa, Inflammation, Chronic Active 12 (12%) 4 (13%) 7 (12%) 5 (8%) 18 (18%) Mucosa, Ulcer 2 (2%) 2 (2%) Sinus, Foreign Body 6 (6%) 2 (6%) 5 (8%) 4 (7%) 15 (15%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Ear (3) (2) Pinna, Inflammation, Chronic Active 1 (50%) Eye (21) (5) (10) (13) (26) Anterior Chamber, Hemorrhage 1 (5%) 1 (4%) Cornea, Inflammation, Acute 1 (4%) Lens, Cataract 19 (90%) 5 (100%) 10 (100%) 13 (100%) 25 (96%) Retina, Atrophy 19 (90%) 5 (100%) 10 (100%) 13 (100%) 25 (96%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (100) (32) (60) (60) (100) Hydronephrosis 1 (1%) Inflammation, Acute, Focal 1 (2%) Nephropathy, Chronic 84 (84%) 27 (84%) 58 (97%) 55 (92%) 82 (82%) Cortex, Cyst 1 (1%) 1 (3%) Cortex, Infarct, Chronic, Multifocal 1 (1%) Renal Tubule, Atrophy 1 (2%) Renal Tubule, Inflammation, Chronic Active 1 (2%) Renal Tubule, Mineralization 9 (9%) 2 (2%) Urinary Bladder (100) (32) (59) (60) (100) Dilatation 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 7 NTP Experiment-Test: 05131-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC SODIUM FLUORIDE Date: 09/17/94 Route: DOSED WATER Time: 03:55:26 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 PPM SPECIAL 25 PPM 100 PPM 175 PPM CONTROL ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 100 50 70 70 100 Scheduled Sacrifice 19 19 20 20 Early Deaths Moribund Sacrifice 21 12 13 13 19 Natural Death 17 6 13 13 19 Accidently Killed 1 Survivors Terminal Sacrifice 42 5 25 23 42 Special Control 27 Wrong Sex 1 Animals Examined Microscopically 99 45 70 70 100 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Cecum (98) (45) (59) (60) (100) Congestion 1 (1%) Ulcer 1 (2%) Intestine Large, Colon (98) (45) (60) (60) (100) Ulcer 1 (2%) Serosa, Inflammation, Chronic Active 1 (2%) Intestine Large, Rectum (98) (45) (60) (60) (100) Parasite Metazoan 1 (1%) 1 (1%) Muscularis, Inflammation, Chronic Active 1 (1%) Intestine Small, Duodenum (99) (45) (60) (60) (100) Ulcer 1 (2%) Intestine Small, Jejunum (99) (45) (60) (60) (100) Inflammation, Chronic Active, Granulomatous 1 (2%) Liver (99) (45) (60) (60) (100) Angiectasis 2 (4%) 2 (2%) Basophilic Focus 18 (18%) 5 (11%) 23 (38%) 15 (25%) 24 (24%) Clear Cell Focus 23 (23%) 2 (4%) 19 (32%) 17 (28%) 20 (20%) Congestion 2 (3%) 1 (1%) Degeneration, Cystic 1 (2%) Eosinophilic Focus 5 (5%) 1 (2%) 3 (5%) 3 (5%) 5 (5%) Hepatodiaphragmatic Nodule 7 (7%) 6 (13%) 5 (8%) 5 (8%) 9 (9%) Hyperplasia 4 (4%) 1 (2%) 3 (5%) 3 (5%) 9 (9%) Infarct 1 (2%) Inflammation, Chronic Active 13 (13%) 3 (7%) 11 (18%) 10 (17%) 10 (10%) Mixed Cell Focus 3 (5%) 1 (1%) Necrosis 2 (2%) Vacuolization Cytoplasmic 32 (32%) 28 (62%) 25 (42%) 21 (35%) 31 (31%) Bile Duct, Hyperplasia 73 (74%) 37 (82%) 48 (80%) 48 (80%) 76 (76%) Centrilobular, Vacuolization Cytoplasmic 1 (1%) a Number of animals examined microscopically at site and number of animals with lesion Page 8 NTP Experiment-Test: 05131-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC SODIUM FLUORIDE Date: 09/17/94 Route: DOSED WATER Time: 03:55:26 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 PPM SPECIAL 25 PPM 100 PPM 175 PPM CONTROL ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Hepatocyte, Cytomegaly, Focal 1 (2%) Hepatocyte, Degeneration, Cystic 13 (13%) 3 (7%) 8 (13%) 10 (17%) 14 (14%) Serosa, Fibrosis 1 (2%) 1 (1%) Subserosa, Congestion 1 (2%) Mesentery (13) (6) (9) (5) (18) Artery, Thrombosis 1 (20%) Fat, Hemorrhage 1 (17%) Fat, Inflammation, Chronic Active 12 (92%) 4 (67%) 7 (78%) 2 (40%) 17 (94%) Pancreas (98) (45) (59) (60) (99) Acinus, Atrophy 34 (35%) 18 (40%) 18 (31%) 22 (37%) 20 (20%) Acinus, Hyperplasia 1 (1%) 1 (2%) 1 (2%) Artery, Inflammation, Chronic Active 5 (5%) 2 (4%) 5 (8%) 6 (6%) Duct, Cyst 2 (3%) Duct, Hyperplasia 1 (1%) Vein, Thrombosis 1 (1%) Salivary Glands (99) (45) (59) (60) (100) Acinus, Atrophy 1 (1%) Stomach, Forestomach (98) (45) (60) (60) (100) Acanthosis 9 (9%) 2 (4%) 3 (5%) 4 (7%) 2 (2%) Inflammation, Acute 1 (1%) Inflammation, Chronic Active 3 (3%) 1 (2%) 1 (2%) 2 (2%) Mineralization 1 (1%) Ulcer 8 (8%) 3 (7%) 8 (13%) 3 (5%) 3 (3%) Submucosa, Ectopic Tissue 1 (2%) Stomach, Glandular (98) (45) (60) (59) (100) Cyst Epithelial Inclusion 1 (2%) Dysplasia 2 (2%) Erosion 1 (2%) Hyperplasia 1 (1%) Inflammation, Chronic Active 1 (2%) Mineralization 3 (3%) 1 (2%) 2 (3%) 1 (1%) Necrosis 4 (4%) 3 (5%) 3 (5%) 6 (6%) Pigmentation, Hemosiderin 3 (5%) 4 (7%) 2 (2%) Ulcer 7 (7%) 3 (7%) 3 (5%) 1 (2%) 1 (1%) Tongue (2) Mucosa, Hyperplasia, Squamous 1 (50%) Tooth (99) (45) (70) (70) (99) Dentine, Incisor, Dysplasia 4 (4%) 7 (10%) 14 (20%) 31 (31%) Dentine, Incisor, Necrosis, Focal 1 (1%) Dentine, Incisor, Necrosis, Multifocal 75 (76%) 33 (73%) 42 (60%) 44 (63%) 73 (74%) Incisor, Odontoblast, Degeneration 1 (1%) 2 (3%) 4 (4%) Incisor, Ameloblast, Degeneration 1 (1%) 7 (10%) 24 (24%) Peridontal Tissue, Fibrosis 1 (1%) Peridontal Tissue, Inflammation, Chronic 1 (1%) Peridontal Tissue, Incisor, Inflammation, Suppurative 2 (2%) Peridontal Tissue, Molar, Inflammation, a Number of animals examined microscopically at site and number of animals with lesion Page 9 NTP Experiment-Test: 05131-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC SODIUM FLUORIDE Date: 09/17/94 Route: DOSED WATER Time: 03:55:26 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 PPM SPECIAL 25 PPM 100 PPM 175 PPM CONTROL ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Chronic, Suppurative 1 (1%) 1 (1%) Peridontal Tissue, Molar, Inflammation, Suppurative 4 (4%) 1 (1%) 2 (2%) Peridontal Tissue, Molar, Lower, Inflammation, Chronic, Suppurative 27 (27%) 22 (49%) 21 (30%) 19 (27%) 33 (33%) Pulp, Incisor, Inflammation, Chronic, Necrotizing 1 (1%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Blood Vessel (1) Aorta, Mineralization 1 (100%) Heart (99) (45) (60) (60) (100) Degeneration, Chronic 91 (92%) 35 (78%) 55 (92%) 52 (87%) 84 (84%) Mineralization 2 (2%) 1 (2%) Thrombosis 6 (6%) 1 (2%) 2 (3%) 3 (5%) 4 (4%) Atrium, Dilatation 1 (2%) 1 (2%) 1 (1%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Gland (99) (45) (60) (60) (100) Capsule, Spindle Cell, Hyperplasia 1 (2%) Adrenal Gland, Cortex (99) (45) (60) (60) (100) Accessory Adrenal Cortical Nodule 1 (1%) Congestion 1 (2%) Hemorrhage 1 (1%) Hyperplasia 10 (10%) 3 (7%) 12 (20%) 12 (20%) 12 (12%) Hypertrophy 1 (2%) 2 (3%) 4 (4%) Vacuolization Cytoplasmic, Focal 6 (6%) 1 (2%) 3 (5%) 6 (10%) 8 (8%) Bilateral, Degeneration, Cystic, Focal 1 (2%) Adrenal Gland, Medulla (98) (45) (60) (60) (100) Hemorrhage 1 (1%) Hyperplasia 33 (34%) 11 (24%) 21 (35%) 17 (28%) 28 (28%) Islets, Pancreatic (98) (45) (58) (60) (100) Hyperplasia 1 (1%) 3 (5%) 1 (2%) 2 (2%) Parathyroid Gland (96) (43) (60) (59) (95) Hyperplasia 1 (1%) 2 (3%) 1 (1%) Pituitary Gland (99) (44) (59) (59) (100) Pars Distalis, Congestion 2 (2%) 3 (5%) 5 (8%) 6 (6%) Pars Distalis, Cyst 6 (6%) 2 (5%) 4 (7%) 4 (7%) 2 (2%) Pars Distalis, Hemorrhage 3 (3%) 1 (2%) 1 (1%) Pars Distalis, Hyperplasia 17 (17%) 6 (14%) 12 (20%) 9 (15%) 9 (9%) Pars Distalis, Inflammation, Chronic Active 1 (1%) Pars Distalis, Karyomegaly 1 (1%) Pars Distalis, Vacuolization Cytoplasmic, a Number of animals examined microscopically at site and number of animals with lesion Page 10 NTP Experiment-Test: 05131-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC SODIUM FLUORIDE Date: 09/17/94 Route: DOSED WATER Time: 03:55:26 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 PPM SPECIAL 25 PPM 100 PPM 175 PPM CONTROL ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM - CONT Focal 1 (2%) Pars Intermedia, Cyst 3 (3%) 2 (5%) 1 (2%) 2 (3%) 2 (2%) Thyroid Gland (99) (45) (60) (60) (100) Metaplasia, Osseous 1 (1%) C-Cell, Hyperplasia 5 (5%) 3 (7%) 4 (7%) 6 (10%) 10 (10%) Follicle, Cyst 2 (2%) 1 (2%) 2 (3%) 2 (2%) Follicular Cell, Hyperplasia 2 (2%) 1 (2%) 1 (1%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Ductus Deferens (1) Hemorrhage 1 (100%) Epididymis (99) (45) (60) (60) (100) Dilatation 2 (2%) Hemorrhage 1 (2%) Inflammation, Chronic Active 2 (4%) 1 (1%) Preputial Gland (99) (45) (60) (57) (100) Hyperplasia 1 (1%) 1 (2%) 1 (2%) 1 (1%) Hyperplasia, Glandular 1 (2%) 1 (2%) 1 (1%) Inflammation, Chronic Active 54 (55%) 30 (67%) 46 (77%) 40 (70%) 66 (66%) Duct, Cyst 4 (4%) 1 (2%) 5 (8%) 4 (7%) 6 (6%) Prostate (98) (45) (59) (59) (100) Atrophy 1 (1%) Dilatation 4 (4%) 1 (2%) 1 (2%) 4 (4%) Hyperplasia 1 (1%) Inflammation, Chronic Active 29 (30%) 11 (24%) 18 (31%) 13 (22%) 17 (17%) Seminal Vesicle (97) (45) (60) (59) (97) Atrophy 2 (2%) 3 (3%) Dilatation 1 (2%) Inflammation, Chronic Active 1 (2%) 1 (1%) Testes (99) (45) (60) (60) (100) Interstitial Cell, Hyperplasia 39 (39%) 30 (67%) 24 (40%) 24 (40%) 39 (39%) Seminiferous Tubule, Atrophy 20 (20%) 5 (11%) 5 (8%) 10 (17%) 10 (10%) Serosa, Inflammation, Chronic Active 1 (2%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 11 NTP Experiment-Test: 05131-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC SODIUM FLUORIDE Date: 09/17/94 Route: DOSED WATER Time: 03:55:26 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 PPM SPECIAL 25 PPM 100 PPM 175 PPM CONTROL ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (98) (45) (60) (60) (100) Femoral, Atrophy 1 (2%) Femoral, Myelofibrosis 2 (2%) Lymph Node (98) (45) (60) (60) (100) Mediastinal, Congestion 1 (2%) Mediastinal, Depletion Lymphoid 1 (2%) Mediastinal, Infiltration Cellular, Histiocyte 1 (2%) Mediastinal, Inflammation, Acute 1 (2%) Renal, Angiectasis 1 (1%) Renal, Congestion 1 (1%) Lymph Node, Mandibular (98) (45) (59) (60) (100) Angiectasis 1 (1%) 2 (3%) 2 (2%) Congestion 1 (2%) Infiltration Cellular, Histiocyte 1 (2%) 1 (1%) Inflammation, Chronic Active 1 (2%) Lymph Node, Mesenteric (97) (45) (59) (59) (96) Angiectasis 1 (2%) 1 (2%) 1 (1%) Congestion 1 (1%) Infiltration Cellular, Histiocyte 1 (2%) Inflammation, Chronic Active 1 (2%) 1 (2%) Spleen (98) (45) (60) (60) (100) Depletion Lymphoid 1 (1%) 1 (2%) 1 (2%) 1 (2%) Fibrosis 10 (10%) 2 (4%) 7 (12%) 9 (15%) 9 (9%) Hematopoietic Cell Proliferation 1 (2%) 1 (2%) 1 (1%) Hyperplasia, Reticulum Cell 1 (2%) Necrosis 1 (2%) 1 (1%) Capsule, Cyst, Multiple 1 (2%) Red Pulp, Atrophy 1 (1%) 1 (2%) Thymus (88) (43) (57) (51) (96) Depletion Lymphoid 54 (61%) 19 (44%) 42 (74%) 38 (75%) 66 (69%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (92) (43) (57) (57) (92) Hemorrhage 1 (1%) Hyperplasia, Cystic 87 (95%) 37 (86%) 55 (96%) 56 (98%) 84 (91%) Duct, Hemorrhage 1 (1%) Skin (99) (45) (60) (60) (100) Acanthosis 1 (1%) Cyst Epithelial Inclusion 2 (3%) Hyperkeratosis 1 (2%) 1 (2%) 1 (2%) Ulcer 1 (2%) Sebaceous Gland, Cyst 1 (2%) Subcutaneous Tissue, Foreign Body 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 12 NTP Experiment-Test: 05131-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC SODIUM FLUORIDE Date: 09/17/94 Route: DOSED WATER Time: 03:55:26 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 PPM SPECIAL 25 PPM 100 PPM 175 PPM CONTROL ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM - CONT Subcutaneous Tissue, Inflammation, Chronic Active 1 (2%) 1 (2%) 2 (2%) Subcutaneous Tissue, Metaplasia, Osseous 1 (1%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (99) (45) (70) (70) (99) Epiphysis, Tibia, Cyst 1 (1%) 1 (1%) Epiphysis, Tibia, Cyst, Multifocal 1 (1%) Femur, Fibrous Osteodystrophy 1 (1%) Femur, Osteosclerosis 1 (1%) Humerus, Fibrous Osteodystrophy 8 (8%) 2 (4%) 6 (9%) 8 (11%) 2 (2%) Humerus, Osteoporosis 1 (1%) Humerus, Osteosclerosis 4 (4%) 1 (2%) 1 (1%) 1 (1%) Humerus, Joint, Cartilage, Degeneration 1 (1%) 1 (1%) 1 (1%) Humerus, Joint, Cartilage, Degeneration, Focal 1 (1%) 1 (1%) Humerus, Joint, Cartilage, Necrosis, Focal 1 (1%) 1 (1%) 1 (1%) Humerus, Epiphysis, Cyst 1 (1%) Humerus, Ligament, Metaplasia, Cartilagenous, Focal 1 (1%) Joint, Cartilage, Tibia, Degeneration 1 (1%) 2 (2%) Joint, Cartilage, Tibia, Necrosis, Focal 1 (1%) Mandible, Fibrous Osteodystrophy 1 (1%) 2 (4%) 1 (1%) 3 (4%) 1 (1%) Maxilla, Fibrous Osteodystrophy 7 (7%) 2 (4%) 5 (7%) 4 (6%) 1 (1%) Maxilla, Fibrous Osteodystrophy, Multifocal 1 (1%) Thoracic, Periosteum, Vertebra, Hyperostosis 1 (1%) Thoracic, Vertebra, Fibrous Osteodystrophy 7 (7%) 1 (2%) 3 (4%) 6 (9%) 3 (3%) Thoracic, Vertebra, Osteosclerosis 1 (1%) Thoracic, Vertebra, Intervertebral Disc, Degeneration 1 (1%) Tibia, Fibrous Osteodystrophy 10 (10%) 3 (7%) 5 (7%) 5 (7%) 2 (2%) Tibia, Necrosis, Focal 1 (1%) Tibia, Osteoporosis 1 (1%) Tibia, Osteosclerosis 2 (2%) 1 (2%) 1 (1%) 4 (6%) 3 (3%) Tibia, Thrombosis, Chronic, Focal 1 (1%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (99) (45) (60) (60) (100) Compression 2 (2%) 1 (2%) 3 (5%) 3 (5%) 2 (2%) Degeneration 1 (1%) Hemorrhage 1 (1%) Hydrocephalus 2 (2%) 2 (3%) 2 (3%) 1 (1%) Necrosis, Subacute 1 (1%) a Number of animals examined microscopically at site and number of animals with lesion Page 13 NTP Experiment-Test: 05131-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC SODIUM FLUORIDE Date: 09/17/94 Route: DOSED WATER Time: 03:55:26 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 PPM SPECIAL 25 PPM 100 PPM 175 PPM CONTROL ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM - CONT Vein, Thrombosis 1 (1%) Peripheral Nerve (1) (1) (1) Sciatic, Degeneration 1 (100%) 1 (100%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (99) (45) (60) (60) (100) Hemorrhage 1 (2%) Inflammation, Chronic Active 1 (1%) 2 (4%) 2 (2%) Inflammation, Chronic Active, Focal 1 (2%) Mineralization 1 (1%) Alveolar Epithelium, Hyperplasia 3 (3%) 2 (4%) 2 (3%) 5 (8%) 3 (3%) Pleura, Hyperplasia 1 (1%) Pleura, Inflammation, Chronic Active 1 (2%) 1 (2%) Nose (99) (45) (60) (60) (100) Inflammation, Chronic Active 4 (4%) 1 (2%) 3 (5%) 3 (3%) Metaplasia, Squamous 4 (4%) 1 (2%) 1 (2%) 3 (3%) Mucosa, Inflammation, Acute 7 (16%) 1 (2%) 2 (3%) 5 (5%) Mucosa, Inflammation, Chronic Active 25 (25%) 6 (13%) 17 (28%) 14 (23%) 22 (22%) Mucosa, Ulcer 1 (1%) 3 (7%) 2 (3%) 1 (1%) Sinus, Foreign Body 20 (20%) 4 (9%) 15 (25%) 11 (18%) 22 (22%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Ear (3) (1) (1) (1) Pinna, Acanthosis 1 (33%) Eye (23) (3) (7) (14) (16) Cornea, Hyperplasia, Squamous 1 (14%) Cornea, Inflammation, Chronic Active 1 (14%) Lens, Cataract 21 (91%) 3 (100%) 7 (100%) 14 (100%) 16 (100%) Retina, Atrophy 22 (96%) 3 (100%) 5 (71%) 14 (100%) 16 (100%) Harderian Gland (1) (2) (1) Hyperplasia 1 (50%) Zymbal's Gland (3) (1) (2) (1) (3) Cyst, Multiple 1 (50%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (98) (45) (60) (60) (100) Hydronephrosis 1 (2%) Nephropathy, Chronic 97 (99%) 44 (98%) 60 (100%) 60 (100%) 99 (99%) Cortex, Cyst 3 (3%) 2 (3%) 4 (7%) 2 (2%) Renal Tubule, Necrosis, Acute, Multifocal 1 (1%) Renal Tubule, Epithelium, Hyperplasia, Focal 1 (1%) a Number of animals examined microscopically at site and number of animals with lesion Page 14 NTP Experiment-Test: 05131-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC SODIUM FLUORIDE Date: 09/17/94 Route: DOSED WATER Time: 03:55:26 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 PPM SPECIAL 25 PPM 100 PPM 175 PPM CONTROL ____________________________________________________________________________________________________________________________________ URINARY SYSTEM - CONT Urinary Bladder (98) (44) (60) (58) (100) Calculus Micro Observation Only 1 (1%) Ectasia 1 (2%) Mucosa, Hyperplasia 1 (1%) Submucosa, Hemorrhage 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 15 ------------------------------------------------------------ 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