TDMS Study 96010-04 Pathology Tables
NTP Experiment-Test: 96010-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18 Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 03/26/03 Route: DOSED WATER WATER DISINFECTION BYPRODUCTS (SODIUM CHLORATE) Time: 10:48:04 FINAL#1/MICE Facility: Southern Research Institute Chemical CAS #: 7775-09-9 Lock Date: 10/16/01 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 b Average severity grade (1-minimal;2-mild;3-moderate;4-marked) Page 1 NTP Experiment-Test: 96010-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18 Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 03/26/03 Route: DOSED WATER WATER DISINFECTION BYPRODUCTS (SODIUM CHLORATE) Time: 10:48:04 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0 MG/L 500 MG/L 1000MG/L 2000MG/L ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 50 50 50 50 Early Deaths Natural Death 10 10 12 7 Moribund Sacrifice 3 5 6 8 Accidently Killed 1 Survivors Terminal Sacrifice 36 34 31 35 Moribund Sacrifice 1 Other 1 Animals Examined Microscopically 50 50 50 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Colon (48) (49) (48) (49) Hemorrhage 1 [3.0] Intestine Large, Cecum (44) (47) (47) (47) Edema 4 [2.0] 6 [2.0] 6 [2.2] 6 [1.8] Hemorrhage 1 [4.0] Inflammation, Chronic 1 [3.0] Ulcer 1 [3.0] Intestine Small, Duodenum (46) (47) (47) (50) Ulcer 1 [4.0] 1 [2.0] Epithelium, Hyperplasia 2 [2.5] Intestine Small, Ileum (42) (45) (46) (47) Inflammation, Chronic 1 [2.0] 1 [3.0] Epithelium, Hyperplasia 1 [2.0] 1 [2.0] Liver (49) (50) (49) (50) Angiectasis 2 [2.0] 2 [3.5] 1 [3.0] Basophilic Focus 5 4 1 Clear Cell Focus 3 1 Eosinophilic Focus 9 9 13 7 Hematopoietic Cell Proliferation 7 [2.1] 4 [2.5] 3 [2.7] 8 [2.3] Hemorrhage 1 [2.0] Hepatodiaphragmatic Nodule 1 Hyperplasia, Lymphoid 4 [2.0] 7 [2.1] 3 [2.0] 5 [2.0] Infarct 1 [3.0] Infiltration Cellular, Mixed Cell 7 [1.9] 7 [1.6] 8 [1.9] 7 [2.1] Mixed Cell Focus 7 2 3 3 Necrosis, Focal 5 [1.8] 1 [1.0] 4 [2.0] 1 [3.0] Tension Lipidosis 2 3 1 a Number of animals examined microscopically at site and number of animals with lesion b Average severity grade (1-minimal;2-mild;3-moderate;4-marked) Page 2 NTP Experiment-Test: 96010-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18 Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 03/26/03 Route: DOSED WATER WATER DISINFECTION BYPRODUCTS (SODIUM CHLORATE) Time: 10:48:04 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0 MG/L 500 MG/L 1000MG/L 2000MG/L ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Centrilobular, Necrosis 2 [2.5] 2 [3.5] 2 [2.5] 2 [3.0] Hepatocyte, Karyomegaly 3 [2.3] Hepatocyte, Vacuolization Cytoplasmic 4 [3.3] 3 [3.3] 6 [3.0] 4 [3.5] Kupffer Cell, Hyperplasia 1 [3.0] 1 [2.0] 2 [3.0] Kupffer Cell, Pigmentation 3 [2.0] 4 [2.3] 4 [1.8] 7 [2.3] Mesentery (30) (32) (27) (24) Angiectasis 1 [3.0] 1 [3.0] Hemorrhage 1 [4.0] Inflammation, Chronic 1 [3.0] Fat, Necrosis 21 [3.0] 24 [3.1] 20 [3.6] 16 [3.3] Pancreas (46) (47) (49) (48) Atrophy 2 [2.5] 1 [4.0] 1 [1.0] Cyst 1 [3.0] 1 [3.0] Acinus, Hyperplasia, Focal 1 [2.0] Salivary Glands (48) (47) (49) (50) Hyperplasia, Lymphoid 16 [2.3] 21 [2.2] 15 [2.4] 18 [2.3] Stomach, Forestomach (49) (50) (50) (49) Diverticulum 2 1 1 2 Edema 3 [2.7] Erosion 1 [2.0] 2 [2.5] 2 [1.5] Hyperplasia 1 [1.0] Inflammation, Chronic Active 2 [1.5] 2 [2.0] Ulcer 2 [2.5] 3 [2.3] 3 [2.3] Epithelium, Hyperplasia 3 [2.3] 4 [2.0] 9 [2.4] 6 [2.2] Stomach, Glandular (49) (48) (50) (49) Erosion 1 [3.0] 2 [2.5] Ulcer 1 [3.0] ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Blood Vessel (1) (3) (1) Aorta, Mineralization 1 [4.0] Heart (49) (50) (49) (50) Cardiomyopathy 1 [2.0] 1 [2.0] 1 [2.0] Mineralization 1 [2.0] 1 [2.0] 2 [3.5] ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (50) (49) (49) (50) Accessory Adrenal Cortical Nodule 4 [3.0] 2 [3.0] 7 [3.0] 7 [3.0] Hyperplasia, Focal 1 [2.0] a Number of animals examined microscopically at site and number of animals with lesion b Average severity grade (1-minimal;2-mild;3-moderate;4-marked) Page 3 NTP Experiment-Test: 96010-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18 Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 03/26/03 Route: DOSED WATER WATER DISINFECTION BYPRODUCTS (SODIUM CHLORATE) Time: 10:48:04 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0 MG/L 500 MG/L 1000MG/L 2000MG/L ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM - CONT Capsule, Hyperplasia 1 [2.0] 2 [2.0] Zona Reticularis, Vacuolization Cytoplasmic 1 [3.0] 1 [3.0] Adrenal Medulla (50) (49) (49) (50) Hyperplasia 2 [1.0] 2 [1.5] 1 [1.0] Islets, Pancreatic (46) (47) (49) (49) Hyperplasia 9 [1.7] 6 [2.0] 4 [2.3] 3 [2.0] Parathyroid Gland (45) (47) (48) (47) Cyst 1 [2.0] 1 [3.0] 2 [2.5] 2 [3.0] Pituitary Gland (46) (45) (48) (50) Pars Distalis, Angiectasis 1 [1.0] 2 [2.5] 2 [1.5] Pars Distalis, Cyst 1 [3.0] Pars Distalis, Hyperplasia, Focal 3 [1.7] 3 [2.3] 3 [2.7] 1 [3.0] Thyroid Gland (48) (50) (49) (50) Degeneration, Cystic 25 [2.3] 28 [2.1] 34 [2.5] 32 [2.3] Follicle, Cyst 1 1 1 Follicular Cell, Cyst 2 Follicular Cell, Hypertrophy 3 [1.3] 2 [2.0] 5 [1.0] 14 [1.4] ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Clitoral Gland (47) (47) (47) (49) Inflammation, Chronic 2 [2.0] 4 [2.3] Ovary (45) (45) (47) (50) Angiectasis 3 [3.0] 2 [3.0] 4 [2.5] 3 [2.7] Cyst 9 14 14 13 Cyst, Hemorrhagic 1 Hemorrhage 1 [2.0] Thrombosis 3 1 1 Bilateral, Cyst 1 Follicle, Hemorrhage 1 [2.0] 4 [3.0] 4 [2.3] 9 [2.2] Granulosa Cell, Hyperplasia 3 [2.7] 7 [2.6] Uterus (50) (50) (50) (50) Angiectasis 1 [2.0] 2 [3.5] 1 [4.0] Hyperplasia, Atypical 1 [3.0] Hyperplasia, Cystic 45 [3.1] 45 [3.2] 40 [3.1] 41 [3.1] Inflammation, Chronic 2 [2.5] Inflammation, Suppurative 1 [4.0] a Number of animals examined microscopically at site and number of animals with lesion b Average severity grade (1-minimal;2-mild;3-moderate;4-marked) Page 4 NTP Experiment-Test: 96010-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18 Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 03/26/03 Route: DOSED WATER WATER DISINFECTION BYPRODUCTS (SODIUM CHLORATE) Time: 10:48:04 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0 MG/L 500 MG/L 1000MG/L 2000MG/L ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM - CONT Metaplasia, Squamous 2 [2.5] 1 [2.0] Endometrium, Hyperplasia, Atypical 1 [2.0] ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (50) (50) (50) (50) Hyperplasia 14 [2.4] 28 [2.6] 29 [2.9] 31 [2.7] Myelofibrosis 1 [3.0] 2 [3.5] 1 [4.0] 2 [2.0] Lymph Node (7) (5) (11) (9) Iliac, Hemorrhage 1 [3.0] Iliac, Hyperplasia, Lymphoid 1 [3.0] 1 [3.0] Mediastinal, Hyperplasia, Lymphoid 1 [3.0] 1 [3.0] 2 [3.5] Mediastinal, Pigmentation 1 [2.0] Pancreatic, Hemorrhage 1 [4.0] Renal, Hemorrhage 1 [4.0] 1 [3.0] Lymph Node, Mandibular (46) (46) (49) (49) Atrophy 1 [3.0] 1 [3.0] Hematopoietic Cell Proliferation 1 [2.0] 1 [2.0] 1 [2.0] Hyperplasia, Lymphoid 12 [2.7] 7 [2.4] 7 [2.3] 10 [2.8] Pigmentation 18 [2.4] 16 [2.6] 18 [2.2] 15 [2.3] Lymph Node, Mesenteric (47) (49) (49) (49) Atrophy 1 [3.0] 1 [3.0] 2 [2.5] Ectasia 2 [3.0] 1 [3.0] Hematopoietic Cell Proliferation 2 [2.0] 2 [2.5] 1 [2.0] 2 [2.0] Hemorrhage 4 [3.3] 2 [4.0] 1 [2.0] Hyperplasia, Lymphoid 10 [2.6] 8 [2.1] 11 [2.8] 6 [2.5] Pigmentation 1 [2.0] 2 [2.5] Spleen (49) (48) (49) (50) Accessory Spleen 1 Hematopoietic Cell Proliferation 39 [2.5] 39 [2.8] 35 [2.8] 39 [2.8] Hyperplasia, Lymphoid 11 [2.6] 10 [2.3] 5 [3.0] 9 [2.4] Pigmentation 28 [2.4] 30 [2.6] 28 [2.6] 27 [2.6] Lymphoid Follicle, Atrophy 1 [3.0] 2 [2.5] 1 [3.0] 2 [3.0] Thymus (48) (44) (48) (48) Atrophy 5 [3.0] 7 [2.9] 5 [3.0] 9 [2.9] Cyst 3 [3.0] 1 [3.0] 1 [3.0] Hyperplasia, Lymphoid 5 [2.8] 3 [2.7] 4 [3.0] 2 [2.0] ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (50) (50) (50) (50) a Number of animals examined microscopically at site and number of animals with lesion b Average severity grade (1-minimal;2-mild;3-moderate;4-marked) Page 5 NTP Experiment-Test: 96010-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18 Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 03/26/03 Route: DOSED WATER WATER DISINFECTION BYPRODUCTS (SODIUM CHLORATE) Time: 10:48:04 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0 MG/L 500 MG/L 1000MG/L 2000MG/L ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM - CONT Hyperplasia 5 [1.4] 11 [1.5] 8 [1.9] 10 [1.4] Skin (48) (50) (50) (50) Edema 1 [3.0] 1 [3.0] Epidermis, Hyperplasia 1 [2.0] 1 [4.0] Subcutaneous Tissue, Edema 1 [4.0] 2 [2.0] ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (50) (50) (50) (50) Callus 1 [4.0] Fracture 1 1 Hyperostosis 1 [3.0] 1 [2.0] 4 [2.0] 3 [2.0] Cranium, Osteopetrosis 1 [3.0] Femur, Osteopetrosis 1 [2.0] 1 [3.0] Skeletal Muscle (2) (4) (6) Angiectasis 1 [3.0] Atrophy 1 [1.0] ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (50) (50) (50) Compression 1 [4.0] 1 [3.0] 1 [4.0] Inflammation, Chronic 1 [2.0] Necrosis 1 [2.0] 1 [3.0] Peripheral Nerve (2) (2) Atrophy 1 [2.0] 2 [1.5] ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (50) (49) (50) Edema 5 [2.0] 8 [2.1] 3 [2.0] 5 [2.0] Foreign Body 2 Hemorrhage 5 [1.4] 8 [1.8] 6 [2.0] 4 [2.3] Hyperplasia, Lymphoid 10 [2.0] 8 [2.1] 3 [2.3] 9 [2.1] Infiltration Cellular, Polymorphonuclear 1 [3.0] Infiltration Cellular, Histiocyte 1 [2.0] 1 [4.0] 3 [2.3] 5 [2.0] Metaplasia, Osseous 1 [1.0] 2 [1.0] Thrombosis 1 [2.0] 4 [2.3] 1 [3.0] Alveolar Epithelium, Hyperplasia 2 [2.0] 2 [1.5] 1 [1.0] 2 [1.0] ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion b Average severity grade (1-minimal;2-mild;3-moderate;4-marked) Page 6 NTP Experiment-Test: 96010-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18 Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 03/26/03 Route: DOSED WATER WATER DISINFECTION BYPRODUCTS (SODIUM CHLORATE) Time: 10:48:04 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0 MG/L 500 MG/L 1000MG/L 2000MG/L ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (50) (48) (50) (50) Inflammation, Chronic 3 [2.3] 3 [2.3] Cornea, Hyperplasia 2 [3.0] 1 [2.0] Harderian Gland (50) (50) (50) (49) Cyst 1 [3.0] Hyperplasia, Focal 1 [2.0] 1 [1.0] 1 [2.0] ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (49) (49) (50) Hydronephrosis 1 [3.0] 1 [3.0] Hyperplasia, Lymphoid 8 [2.1] 9 [2.1] 6 [2.2] 8 [2.1] Infarct 3 [2.0] 2 [2.5] 4 [1.8] 5 [1.8] Metaplasia, Osseous 1 [1.0] 3 [1.3] 2 [1.5] Nephropathy 14 [1.3] 11 [1.4] 14 [1.6] 12 [1.4] Renal Tubule, Accumulation, Hyaline Droplet 2 [2.5] 1 [2.0] 2 [2.5] 1 [3.0] Renal Tubule, Dilatation 1 [3.0] 1 [3.0] Renal Tubule, Necrosis 1 [3.0] 1 [3.0] Renal Tubule, Pigmentation 3 [2.3] 1 [2.0] 1 [2.0] Transitional Epithelium, Hyperplasia 1 [1.0] Urinary Bladder (49) (50) (50) (50) Hyperplasia, Lymphoid 4 [2.0] 12 [2.4] 4 [2.0] 5 [2.0] Transitional Epithelium, Hyperplasia 1 [3.0] a Number of animals examined microscopically at site and number of animals with lesion b Average severity grade (1-minimal;2-mild;3-moderate;4-marked) Page 7 NTP Experiment-Test: 96010-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18 Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 03/26/03 Route: DOSED WATER WATER DISINFECTION BYPRODUCTS (SODIUM CHLORATE) Time: 10:48:04 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0 MG/L 500 MG/L 1000MG/L 2000MG/L ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 50 50 50 50 Early Deaths Natural Death 7 4 5 7 Moribund Sacrifice 5 5 4 10 Survivors Terminal Sacrifice 38 41 41 33 Animals Examined Microscopically 50 50 50 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Cecum (47) (49) (49) (48) Edema 1 [2.0] 3 [2.0] 4 [2.0] 2 [2.0] Inflammation, Chronic 1 [3.0] 1 [2.0] Intestine Small, Duodenum (48) (50) (49) (49) Ulcer 1 [2.0] 1 [4.0] Epithelium, Hyperplasia 1 [2.0] 1 [3.0] Intestine Small, Jejunum (47) (49) (50) (50) Epithelium, Hyperplasia 2 [2.5] Intestine Small, Ileum (47) (49) (49) (49) Cyst 1 [3.0] Liver (48) (50) (50) (50) Angiectasis 2 [2.5] 2 [1.5] Basophilic Focus 2 3 4 Clear Cell Focus 12 19 19 13 Cyst 1 [2.5] 1 [3.0] Eosinophilic Focus 11 10 5 11 Hematopoietic Cell Proliferation 1 [3.0] 4 [2.0] Hemorrhage 1 [3.0] 1 [2.0] Hyperplasia, Lymphoid 1 [2.0] 1 [2.0] Infarct 1 [2.0] Infiltration Cellular, Mixed Cell 2 [1.5] 1 [2.0] 1 [1.0] Mixed Cell Focus 2 9 8 7 Necrosis, Focal 4 [2.3] 6 [2.8] 7 [2.3] 6 [3.2] Regeneration, Focal 1 [2.0] Tension Lipidosis 1 1 Bile Duct, Hyperplasia 2 [2.0] Centrilobular, Necrosis 1 [3.0] 2 [3.0] Hepatocyte, Karyomegaly 1 [2.0] 1 [2.0] Hepatocyte, Vacuolization Cytoplasmic 2 [3.0] 3 [2.7] Kupffer Cell, Pigmentation 2 [4.0] 1 [4.0] a Number of animals examined microscopically at site and number of animals with lesion b Average severity grade (1-minimal;2-mild;3-moderate;4-marked) Page 8 NTP Experiment-Test: 96010-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18 Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 03/26/03 Route: DOSED WATER WATER DISINFECTION BYPRODUCTS (SODIUM CHLORATE) Time: 10:48:04 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0 MG/L 500 MG/L 1000MG/L 2000MG/L ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Mesentery (9) (10) (10) (8) Infarct 1 Inflammation, Chronic 1 [3.0] 2 [4.0] Fat, Necrosis 3 [3.7] 8 [3.1] 6 [3.2] 5 [3.2] Pancreas (48) (50) (50) (50) Cyst 2 [3.0] Acinus, Cytoplasmic Alteration 1 [3.0] 1 [3.0] Salivary Glands (50) (50) (50) (50) Atrophy 1 [2.0] 2 [2.0] Hyperplasia, Lymphoid 7 [2.3] 3 [2.0] 6 [2.0] 4 [2.0] Stomach, Forestomach (49) (50) (50) (50) Cyst 2 Diverticulum 1 1 2 Erosion 1 [2.0] Inflammation, Chronic Active 2 [3.0] 2 [2.5] 4 [1.8] 2 [2.0] Ulcer 1 [3.0] 1 [2.0] 2 [2.0] 1 [2.0] Epithelium, Hyperplasia 3 [3.0] 7 [2.3] 2 [2.5] 4 [2.0] Stomach, Glandular (48) (50) (50) (50) Cyst 1 [3.0] 2 [3.0] 1 [3.0] Ulcer 1 [3.0] Tooth (2) (4) (1) (3) Malformation 2 4 2 ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (50) (50) (50) (50) Cardiomyopathy 2 [2.5] Inflammation, Chronic 2 [2.0] 1 [3.0] 1 [1.0] 1 [3.0] Mineralization 1 [3.0] 2 [2.0] Thrombosis 1 [4.0] 1 [4.0] ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (50) (50) (50) (50) Accessory Adrenal Cortical Nodule 6 [3.0] 5 [3.0] 3 [3.0] 5 [3.0] Degeneration, Fatty 1 [1.0] 1 [2.0] 2 [1.0] Hyperplasia, Focal 4 [1.5] 6 [1.7] 7 [1.7] 9 [1.4] Hypertrophy 1 [2.0] Hypertrophy, Focal 9 [1.7] 16 [1.8] 11 [1.7] 11 [1.9] Capsule, Hyperplasia 5 [2.0] 3 [2.0] 1 [3.0] 8 [2.4] Adrenal Medulla (49) (48) (49) (49) a Number of animals examined microscopically at site and number of animals with lesion b Average severity grade (1-minimal;2-mild;3-moderate;4-marked) Page 9 NTP Experiment-Test: 96010-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18 Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 03/26/03 Route: DOSED WATER WATER DISINFECTION BYPRODUCTS (SODIUM CHLORATE) Time: 10:48:04 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0 MG/L 500 MG/L 1000MG/L 2000MG/L ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM - CONT Hyperplasia 1 [1.0] 1 [2.0] 1 [2.0] Islets, Pancreatic (48) (50) (50) (50) Hyperplasia 31 [2.4] 25 [2.3] 28 [2.5] 23 [2.3] Parathyroid Gland (46) (48) (47) (49) Cyst 1 [3.0] 2 [3.0] 1 [3.0] Pituitary Gland (47) (47) (45) (49) Pars Distalis, Cyst 1 [3.0] 1 [3.0] 2 [3.0] 5 [3.0] Pars Intermedia, Cyst 1 [3.0] Thyroid Gland (48) (50) (48) (50) Degeneration, Cystic 13 [1.8] 17 [2.0] 14 [1.9] 15 [1.7] Follicular Cell, Hypertrophy 2 [1.0] 1 [1.0] 2 [1.5] ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Epididymis (50) (50) (50) (50) Atypia Cellular 1 [2.0] 6 [2.2] 4 [2.3] 3 [2.3] Granuloma Sperm 1 [4.0] 1 [4.0] Inflammation, Chronic 1 [3.0] 1 [2.0] 1 [3.0] Preputial Gland (50) (50) (50) (50) Cyst 22 [3.0] 26 [3.0] 15 [3.0] 29 [3.0] Inflammation, Chronic 28 [2.4] 27 [2.4] 18 [2.2] 21 [2.2] Prostate (50) (50) (50) (50) Inflammation, Chronic 1 [2.0] 4 [2.0] 3 [2.7] 5 [2.4] Seminal Vesicle (50) (50) (50) (50) Degeneration 1 [3.0] 2 [3.0] Dilatation 1 [3.0] Inflammation, Chronic 3 [2.3] 1 [4.0] Testes (50) (50) (50) (50) Angiectasis 1 [3.0] 1 [4.0] Atrophy 1 [2.0] 1 [3.0] 1 [3.0] Necrosis 1 [3.0] Germinal Epithelium, Atrophy 1 [1.0] 5 [2.0] 3 [1.7] 4 [1.8] ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (49) (50) (50) (50) a Number of animals examined microscopically at site and number of animals with lesion b Average severity grade (1-minimal;2-mild;3-moderate;4-marked) Page 10 NTP Experiment-Test: 96010-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18 Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 03/26/03 Route: DOSED WATER WATER DISINFECTION BYPRODUCTS (SODIUM CHLORATE) Time: 10:48:04 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0 MG/L 500 MG/L 1000MG/L 2000MG/L ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - CONT Hyperplasia 21 [2.2] 12 [2.6] 13 [2.2] 15 [2.6] Lymph Node (3) (1) (3) Mediastinal, Hemorrhage 1 [3.0] Lymph Node, Mandibular (49) (48) (45) (49) Atrophy 1 [3.0] 1 [2.0] Hyperplasia, Lymphoid 14 [2.4] 14 [2.3] 16 [2.2] 16 [2.3] Pigmentation 7 [2.0] 10 [2.2] 9 [2.1] 9 [2.1] Lymph Node, Mesenteric (47) (50) (50) (50) Atrophy 2 [2.5] 1 [2.0] 1 [3.0] Hematopoietic Cell Proliferation 2 [2.5] 4 [2.5] 1 [2.0] Hemorrhage 4 [1.8] 6 [2.3] 2 [2.0] 4 [2.5] Hyperplasia, Lymphoid 11 [2.7] 6 [2.8] 6 [2.8] 9 [2.6] Spleen (48) (50) (50) (50) Depletion Lymphoid 1 [3.0] Hematopoietic Cell Proliferation 21 [2.8] 17 [2.6] 18 [2.8] 21 [3.3] Hyperplasia, Lymphoid 8 [2.3] 9 [2.0] 10 [2.2] 8 [2.1] Pigmentation 3 [2.0] 1 [2.0] 1 [3.0] Lymphoid Follicle, Atrophy 1 [3.0] 1 [2.0] 3 [3.0] Thymus (43) (43) (40) (44) Atrophy 11 [2.6] 13 [2.6] 4 [2.5] 13 [2.5] Cyst 1 [3.0] 3 [3.0] 4 [3.0] 4 [3.0] Hyperplasia, Lymphoid 2 [3.0] 1 [2.0] ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Skin (50) (50) (50) (50) Cyst Epithelial Inclusion 1 Edema 3 [3.0] Inflammation, Chronic 1 [3.0] 1 [3.0] Ulcer 2 [3.5] Epidermis, Hyperplasia 1 [3.0] 1 [3.0] ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (50) (50) (50) (50) Fracture 1 1 2 Hyperostosis 1 [3.0] 1 [3.0] Skeletal Muscle (3) (1) (3) (2) Atrophy 1 [2.0] Infiltration Cellular, Lipocyte 1 [3.0] ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion b Average severity grade (1-minimal;2-mild;3-moderate;4-marked) Page 11 NTP Experiment-Test: 96010-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18 Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 03/26/03 Route: DOSED WATER WATER DISINFECTION BYPRODUCTS (SODIUM CHLORATE) Time: 10:48:04 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0 MG/L 500 MG/L 1000MG/L 2000MG/L ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Peripheral Nerve (1) (2) (1) Atrophy 1 [3.0] ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (50) (50) (50) Edema 6 [2.2] 11 [2.1] 7 [2.0] 8 [2.0] Foreign Body 1 1 Hemorrhage 5 [1.6] 3 [2.0] 4 [1.3] 5 [2.0] Hyperplasia, Lymphoid 4 [2.0] 5 [2.0] 7 [2.0] 6 [2.0] Infiltration Cellular, Histiocyte 8 [2.6] 5 [3.0] 9 [3.1] 10 [2.5] Metaplasia, Osseous 2 [1.0] Alveolar Epithelium, Hyperplasia 2 [1.0] 3 [1.7] 1 [1.0] 5 [1.6] Nose (50) (50) (50) (50) Foreign Body 1 1 2 Inflammation, Chronic 1 [1.0] 2 [2.5] 1 [1.0] 5 [2.8] Respiratory Epithelium, Hyperplasia 1 [1.0] 1 [2.0] ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (49) (50) (50) (50) Cataract 1 [2.0] Inflammation, Chronic 3 [2.0] Harderian Gland (50) (50) (50) (49) Hyperplasia, Focal 1 [2.0] 1 [2.0] Inflammation, Chronic 1 [2.0] 3 [2.3] 3 [2.0] 2 [3.0] ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (49) (50) (50) (50) Cyst 14 [3.0] 10 [3.0] 9 [3.0] 10 [2.9] Hydronephrosis 1 [2.0] 2 [2.0] 2 [2.0] 1 [3.0] Hyperplasia, Lymphoid 8 [2.3] 6 [2.5] 4 [2.3] 11 [2.3] Infarct 5 [1.8] 1 [1.0] 4 [1.3] 5 [2.2] Inflammation, Chronic 1 [3.0] 1 [2.0] Metaplasia, Osseous 7 [1.4] 5 [2.0] 3 [2.7] 4 [2.5] Nephropathy 37 [1.3] 42 [1.7] 43 [1.5] 36 [1.6] Renal Tubule, Accumulation, Hyaline Droplet 1 [3.0] 1 [3.0] a Number of animals examined microscopically at site and number of animals with lesion b Average severity grade (1-minimal;2-mild;3-moderate;4-marked) Page 12 NTP Experiment-Test: 96010-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18 Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 03/26/03 Route: DOSED WATER WATER DISINFECTION BYPRODUCTS (SODIUM CHLORATE) Time: 10:48:04 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0 MG/L 500 MG/L 1000MG/L 2000MG/L ____________________________________________________________________________________________________________________________________ URINARY SYSTEM - CONT Renal Tubule, Dilatation 1 [2.0] 2 [2.5] 3 [2.3] Renal Tubule, Hyperplasia 1 [1.0] 1 [1.0] 1 [1.0] Renal Tubule, Necrosis 1 [2.0] 2 [3.5] Renal Tubule, Pigmentation 2 [4.0] 1 [2.0] 1 [2.0] Urethra (1) Angiectasis 1 [4.0] Urinary Bladder (49) (50) (50) (50) Edema 1 [3.0] 1 [4.0] Hyperplasia, Lymphoid 1 [2.0] 1 [2.0] Inflammation, Chronic 1 [3.0] Transitional Epithelium, Hyperplasia 2 [2.0] 1 [3.0] a Number of animals examined microscopically at site and number of animals with lesion b Average severity grade (1-minimal;2-mild;3-moderate;4-marked) Page 13 ------------------------------------------------------------ ---------- END OF REPORT ---------- 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