TDMS Study 96021-01 Pathology Tables
NTP Experiment-Test: 96021-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18 Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 10/09/03 Route: GAVAGE TOXIC EQUIVALENCY FACTOR EVALUATION (PCB 153) Time: 10:00:49 FINAL #3 Facility: Battelle Columbus Laboratory Chemical CAS #: 35065-27-1 Lock Date: 01/16/02 Cage Range: All Reasons For Removal: 25018 Dosing Accident 25019 Moribund Sacrifice 25020 Natural Death 25021 Terminal Sacrifice 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: 96021-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18 Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 10/09/03 Route: GAVAGE TOXIC EQUIVALENCY FACTOR EVALUATION (PCB 153) Time: 10:00:49 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 0 UG/KG 10 UG/KG 100 300 1000 3000 UG/KG UG/KG UG/KG UG/KG ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 98 86 98 98 98 80 Early Deaths Natural Death 11 15 8 9 15 11 Moribund Sacrifice 18 23 17 22 18 19 Dosing Accident 1 Survivors Terminal Sacrifice 24 16 28 20 20 21 Natural Death 1 Animals Examined Microscopically 53 54 53 53 53 51 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Esophagus (53) (54) (53) (53) (53) (51) Muscularis, Inflammation 3 [2.0] 1 [2.0] 2 [2.0] 1 [2.0] Periesophageal Tissue, Hemorrhage 1 [3.0] Periesophageal Tissue, Inflammation 1 [2.0] Intestine Large, Colon (53) (54) (53) (53) (53) (50) Inflammation, Chronic Active 1 [3.0] Parasite Metazoan 1 1 1 2 Intestine Large, Rectum (53) (54) (53) (53) (53) (50) Inflammation, Chronic Active 1 [3.0] Parasite Metazoan 1 2 3 7 5 5 Intestine Large, Cecum (53) (54) (53) (53) (53) (50) Inflammation, Chronic Active 1 [3.0] Intestine Small, Duodenum (53) (54) (53) (53) (53) (51) Parasite Metazoan 1 Intestine Small, Jejunum (53) (54) (53) (53) (53) (50) Peyer's Patch, Hyperplasia, Lymphoid 1 [2.0] 1 [3.0] Intestine Small, Ileum (52) (54) (53) (53) (53) (50) Hyperplasia, Lymphoid 1 [3.0] Liver (53) (54) (53) (53) (53) (51) Angiectasis 5 [1.8] 2 [2.5] 2 [1.0] 1 [1.0] 8 [1.9] 4 [1.5] Basophilic Focus 8 5 16 6 3 8 Basophilic Focus, Multiple 8 12 9 7 7 2 Cholangiofibrosis 1 [2.0] Clear Cell Focus 3 3 4 2 Clear Cell Focus, Multiple 3 2 1 Eosinophilic Focus 5 1 8 7 14 6 Eosinophilic Focus, Multiple 7 1 8 12 9 12 Fatty Change, Diffuse 3 [1.0] 7 [1.4] 2 [1.0] 11 [1.0] 21 [1.3] 17 [1.2] 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: 96021-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18 Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 10/09/03 Route: GAVAGE TOXIC EQUIVALENCY FACTOR EVALUATION (PCB 153) Time: 10:00:49 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 0 UG/KG 10 UG/KG 100 300 1000 3000 UG/KG UG/KG UG/KG UG/KG ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Fatty Change, Focal 4 [1.0] 3 [1.0] 5 [1.2] 4 [1.0] 1 [1.0] Hematopoietic Cell Proliferation 20 [1.1] 22 [1.1] 13 [1.1] 18 [1.3] 16 [1.0] 14 [1.2] Hepatodiaphragmatic Nodule 1 1 Hyperplasia, Nodular 1 Inflammation 44 [1.2] 39 [1.2] 44 [1.1] 47 [1.1] 48 [1.1] 45 [1.3] Mixed Cell Focus 8 3 7 6 5 3 Mixed Cell Focus, Multiple 21 16 22 19 19 12 Necrosis 7 [2.4] 7 [2.0] 7 [2.1] 5 [1.6] 12 [2.1] 10 [2.3] Pigmentation 1 [1.0] 1 [1.0] 2 [1.5] 5 [1.6] 5 [1.2] 9 [1.0] Bile Duct, Cyst 3 [2.7] 2 [2.0] 2 [2.5] 3 [2.0] 5 [2.6] 2 [2.5] Bile Duct, Fibrosis 2 [1.0] 1 [1.0] 2 [1.5] 2 [1.0] 2 [1.0] 3 [1.0] Bile Duct, Hyperplasia 5 [1.8] 3 [2.0] 2 [1.0] 14 [1.6] 10 [1.6] 17 [1.6] Centrilobular, Degeneration 2 [2.0] 10 [2.4] 4 [2.3] 2 [2.0] 2 [2.0] 5 [2.0] Hepatocyte, Hypertrophy 5 [1.2] 5 [1.4] 24 [1.4] 39 [2.0] 41 [2.3] Oval Cell, Hyperplasia 1 [1.0] 4 [1.3] Serosa, Fibrosis 1 [3.0] Serosa, Inflammation 2 [3.0] Mesentery (1) (1) Fat, Inflammation, Chronic Active 1 [3.0] Oral Mucosa (21) (12) (16) (12) (16) (25) Gingival, Hyperplasia, Squamous 21 [1.0] 10 [1.7] 16 [1.1] 11 [1.1] 16 [1.4] 25 [1.1] Pancreas (53) (54) (53) (53) (53) (51) Cyst 1 [2.0] Degeneration 1 [2.0] Inflammation, Chronic Active 2 [2.0] 1 [1.0] 1 [2.0] 2 [1.0] Acinus, Atrophy 1 [1.0] 1 [2.0] 1 [2.0] 2 [1.5] Acinus, Hyperplasia 3 [2.7] Acinus, Vacuolization Cytoplasmic 1 [1.0] 1 [1.0] 2 [1.5] Salivary Glands (51) (52) (53) (52) (53) (51) Ectopic Tissue 1 Stomach, Forestomach (53) (54) (53) (53) (53) (51) Hyperkeratosis 1 [2.0] 1 [2.0] 2 [2.0] Hyperplasia, Squamous 3 [2.0] 4 [1.8] 2 [2.0] 6 [1.7] 4 [1.8] 4 [2.5] Inflammation 3 [2.0] 3 [1.7] 2 [3.0] Mineralization 1 [1.0] 2 [1.5] 2 [2.0] Ulcer 2 [3.0] 3 [2.0] 1 [2.0] Serosa, Inflammation, Chronic Active 1 [3.0] Stomach, Glandular (53) (54) (53) (53) (53) (51) Erosion 1 [2.0] 1 [2.0] 2 [2.0] Inflammation 2 [2.0] Mineralization 5 [1.8] 8 [1.3] 8 [1.3] 10 [1.5] 10 [1.5] 2 [1.5] Tooth (34) (13) (19) (22) (23) (35) Degeneration 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 3 NTP Experiment-Test: 96021-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18 Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 10/09/03 Route: GAVAGE TOXIC EQUIVALENCY FACTOR EVALUATION (PCB 153) Time: 10:00:49 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 0 UG/KG 10 UG/KG 100 300 1000 3000 UG/KG UG/KG UG/KG UG/KG ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Peridontal Tissue, Inflammation 33 [1.2] 13 [1.4] 19 [1.1] 21 [1.2] 23 [1.4] 35 [1.3] ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Blood Vessel (52) (54) (53) (53) (53) (51) Aorta, Mineralization 2 [2.0] 1 [2.0] 1 [2.0] 1 [2.0] Heart (52) (54) (53) (53) (53) (51) Cardiomyopathy 22 [1.1] 18 [1.2] 19 [1.0] 19 [1.2] 23 [1.1] 24 [1.1] Inflammation 2 [3.0] 1 [2.0] 1 [1.0] Mineralization 1 [2.0] 1 [1.0] Necrosis 1 [3.0] Thrombosis 2 [3.0] ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (53) (54) (53) (53) (53) (51) Angiectasis 21 [1.9] 23 [1.7] 34 [1.8] 25 [1.6] 29 [1.6] 21 [1.9] Atrophy 1 [2.0] 2 [2.0] Degeneration, Cystic 9 [2.1] 12 [2.2] 15 [2.3] 13 [2.2] 12 [2.0] 13 [1.8] Hematopoietic Cell Proliferation 1 [1.0] 1 [1.0] 3 [1.3] Hyperplasia 18 [2.4] 24 [2.4] 27 [2.6] 27 [2.4] 28 [2.4] 11 [2.5] Hypertrophy 48 [2.1] 35 [1.9] 45 [1.8] 35 [1.9] 42 [1.9] 41 [2.0] Inflammation 1 [1.0] 1 [1.0] Mineralization 2 [2.0] 1 [2.0] Necrosis 1 [3.0] 2 [2.5] 1 [2.0] 2 [3.5] 3 [2.7] 3 [2.0] Vacuolization Cytoplasmic 10 [1.3] 8 [1.5] 14 [1.5] 16 [1.8] 12 [1.5] 14 [1.6] Adrenal Medulla (53) (54) (53) (53) (53) (51) Angiectasis 1 [2.0] 1 [2.0] Hyperplasia 18 [2.1] 14 [2.1] 19 [1.9] 14 [2.3] 20 [2.1] 12 [1.9] Islets, Pancreatic (53) (54) (53) (53) (53) (51) Hyperplasia 1 [2.0] 1 [2.0] 1 [2.0] Parathyroid Gland (49) (46) (50) (47) (46) (48) Angiectasis 1 [1.0] Cyst 1 [2.0] Fibrosis 1 [3.0] Hyperplasia 2 [1.5] 1 [2.0] 1 [2.0] Pituitary Gland (53) (54) (53) (53) (53) (50) Angiectasis 15 [2.0] 16 [2.5] 20 [2.5] 26 [2.2] 28 [2.4] 14 [2.3] Atypia Cellular 1 [2.0] Cyst 1 [2.0] 1 [2.0] Cytoplasmic Alteration 2 [1.5] 1 [2.0] 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 4 NTP Experiment-Test: 96021-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18 Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 10/09/03 Route: GAVAGE TOXIC EQUIVALENCY FACTOR EVALUATION (PCB 153) Time: 10:00:49 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 0 UG/KG 10 UG/KG 100 300 1000 3000 UG/KG UG/KG UG/KG UG/KG ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM - CONT Vacuolization Cytoplasmic 1 [1.0] Pars Distalis, Hyperplasia 23 [2.4] 18 [2.2] 22 [2.4] 16 [2.4] 23 [2.3] 25 [2.2] Thyroid Gland (51) (52) (53) (53) (53) (51) Angiectasis 1 [2.0] 1 [2.0] C-Cell, Hyperplasia 19 [1.9] 17 [2.1] 23 [2.0] 17 [1.6] 19 [1.9] 16 [1.9] Follicular Cell, Hyperplasia 1 [2.0] 2 [2.0] 2 [1.5] Follicular Cell, Hypertrophy 5 [2.0] 9 [1.7] 9 [1.9] 12 [1.7] 10 [2.1] 17 [1.8] ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Clitoral Gland (53) (51) (52) (53) (51) (50) Atrophy 1 [2.0] Inflammation 52 [1.6] 45 [1.9] 41 [1.8] 48 [1.6] 48 [1.6] 46 [1.4] Inflammation, Chronic Active 1 [4.0] Duct, Cyst 49 [2.3] 40 [2.5] 36 [2.4] 43 [2.4] 45 [2.3] 41 [2.3] Ovary (53) (53) (53) (53) (53) (50) Atrophy 47 [4.0] 43 [4.0] 42 [4.0] 38 [4.0] 44 [3.9] 39 [3.9] Cyst 14 [2.2] 7 [2.3] 17 [2.2] 17 [2.2] 16 [2.3] 17 [2.2] Inflammation, Chronic Active 2 [3.5] 1 [2.0] 5 [3.0] 7 [3.6] Necrosis 1 [2.0] Interstitial Cell, Hyperplasia 1 [2.0] 1 [3.0] Oviduct (50) (38) (44) (35) (39) (45) Cyst 1 [2.0] 2 [3.0] 1 [2.0] 1 [3.0] Dilatation 1 [3.0] 1 [4.0] Inflammation, Chronic Active 1 [3.0] 2 [2.5] 1 [3.0] 5 [3.2] 7 [3.3] Uterus (53) (54) (53) (53) (53) (50) Adenomyosis 2 [3.5] 1 [2.0] 1 [2.0] 1 [3.0] Angiectasis 1 [3.0] 1 [3.0] Congestion 1 [1.0] Cyst 1 [3.0] 1 [3.0] Hemorrhage 2 [3.0] Inflammation, Chronic Active 2 [3.0] 1 [3.0] 5 [2.4] 4 [2.8] 2 [3.0] 8 [3.0] Inflammation, Suppurative 5 [1.6] 6 [1.8] 6 [1.8] 2 [1.0] 16 [2.0] 8 [1.6] Metaplasia, Squamous 23 [2.3] 29 [2.1] 27 [2.5] 17 [2.3] 27 [2.7] 32 [2.6] Thrombosis 1 [3.0] 2 [3.0] Ulcer 1 [2.0] Cervix, Hyperplasia, Stromal 1 [3.0] 2 [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 5 NTP Experiment-Test: 96021-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18 Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 10/09/03 Route: GAVAGE TOXIC EQUIVALENCY FACTOR EVALUATION (PCB 153) Time: 10:00:49 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 0 UG/KG 10 UG/KG 100 300 1000 3000 UG/KG UG/KG UG/KG UG/KG ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM - CONT Cervix, Inflammation, Suppurative 1 [3.0] Endometrium, Hyperplasia, Cystic 37 [2.4] 29 [2.1] 32 [2.4] 28 [2.3] 25 [2.2] 21 [2.1] Endometrium, Hyperplasia, Stromal 1 [3.0] Vagina (1) (3) (2) (1) (1) (3) Inflammation 1 [1.0] ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (53) (54) (53) (53) (53) (51) Hyperplasia 34 [2.9] 41 [3.3] 40 [3.0] 38 [3.1] 42 [3.2] 46 [2.9] Lymph Node (3) (3) (3) (2) (5) (6) Hemorrhage 1 [2.0] Hyperplasia, Lymphoid 1 [3.0] Hyperplasia, Plasma Cell 1 [3.0] 1 [3.0] Iliac, Ectasia 1 [2.0] Iliac, Hyperplasia, Plasma Cell 1 [3.0] Lumbar, Ectasia 1 [3.0] 2 [3.0] 2 [2.5] Lumbar, Hemorrhage 1 [2.0] 1 [2.0] Lumbar, Hyperplasia, Histiocytic 1 [2.0] Lumbar, Hyperplasia, Plasma Cell 1 [3.0] 2 [2.0] Mediastinal, Congestion 3 [2.0] Mediastinal, Ectasia 2 [2.0] Mediastinal, Hyperplasia, Histiocytic 1 [2.0] Mediastinal, Hyperplasia, Lymphoid 1 [2.0] 1 [2.0] Mediastinal, Hyperplasia, Plasma Cell 1 [3.0] 1 [2.0] Renal, Ectasia 2 [3.5] Renal, Hyperplasia, Plasma Cell 1 [2.0] Renal, Inflammation, Chronic Active 1 [4.0] Lymph Node, Mandibular (51) (52) (53) (51) (53) (51) Congestion 1 [2.0] Ectasia 1 [2.0] 1 [2.0] 1 [3.0] Hemorrhage 1 [2.0] Hyperplasia, Lymphoid 1 [2.0] 1 [2.0] 2 [2.5] 1 [2.0] 3 [2.3] 1 [2.0] Hyperplasia, Plasma Cell 37 [2.3] 36 [2.2] 30 [2.3] 33 [2.4] 37 [2.4] 38 [2.3] Inflammation 1 [3.0] Lymph Node, Mesenteric (52) (54) (53) (53) (53) (51) Ectasia 1 [1.0] Hemorrhage 1 [2.0] Hyperplasia, Plasma Cell 1 [3.0] Inflammation, Chronic Active 1 [4.0] Spleen (53) (54) (53) (53) (53) (51) Hematopoietic Cell Proliferation 46 [1.7] 48 [2.3] 52 [2.2] 48 [1.9] 46 [1.8] 47 [1.7] 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: 96021-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18 Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 10/09/03 Route: GAVAGE TOXIC EQUIVALENCY FACTOR EVALUATION (PCB 153) Time: 10:00:49 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 0 UG/KG 10 UG/KG 100 300 1000 3000 UG/KG UG/KG UG/KG UG/KG ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - CONT Hemorrhage 1 [3.0] Infarct 1 [3.0] Necrosis 1 [2.0] 1 [2.0] 1 [3.0] Pigmentation 47 [1.5] 42 [1.5] 47 [1.6] 49 [1.4] 49 [1.5] 46 [1.4] Lymphoid Follicle, Atrophy 1 [2.0] 6 [2.3] 2 [2.0] 3 [2.7] 3 [2.0] 3 [2.7] Red Pulp, Atrophy 2 [2.5] Thymus (48) (53) (52) (53) (53) (47) Atrophy 38 [2.6] 38 [2.7] 37 [2.7] 35 [2.6] 41 [2.7] 30 [2.6] Cyst 1 [3.0] 1 [2.0] Hemorrhage 3 [2.3] ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (53) (54) (53) (53) (53) (51) Cyst 2 [3.0] 1 [3.0] 2 [2.5] 1 [2.0] 3 [2.7] Hyperplasia 22 [1.5] 23 [1.4] 32 [1.2] 27 [1.4] 32 [1.3] 22 [1.4] Inflammation, Chronic Active 1 [3.0] Inflammation, Granulomatous 2 [2.0] 2 [2.0] 3 [1.7] 1 [2.0] Skin (53) (54) (53) (53) (53) (51) Cyst 1 [2.0] Cyst Epithelial Inclusion 1 1 Inflammation 1 [2.0] ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM None ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (53) (54) (53) (53) (53) (51) Hemorrhage 1 [3.0] 1 [2.0] 1 [2.0] 2 [3.0] Hydrocephalus 2 [2.0] 1 [1.0] Hyperplasia, Histiocytic 1 [3.0] Mineralization 1 [2.0] Necrosis 1 [3.0] 1 [2.0] Vacuolization Cytoplasmic 1 [2.0] Glial Cell, 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: 96021-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18 Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 10/09/03 Route: GAVAGE TOXIC EQUIVALENCY FACTOR EVALUATION (PCB 153) Time: 10:00:49 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 0 UG/KG 10 UG/KG 100 300 1000 3000 UG/KG UG/KG UG/KG UG/KG ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (52) (54) (53) (53) (53) (51) Congestion 1 [2.0] Hemorrhage 1 [2.0] 1 [1.0] Infiltration Cellular, Histiocyte 45 [1.6] 40 [1.6] 40 [1.8] 40 [1.4] 27 [1.4] 28 [1.3] Inflammation 6 [2.2] 7 [1.9] 2 [2.0] 6 [2.2] 7 [1.7] 9 [1.7] Metaplasia, Squamous 1 [1.0] 1 [2.0] 1 [2.0] Mineralization 1 [3.0] 1 [3.0] Alveolar Epithelium, Hyperplasia 20 [1.1] 21 [1.4] 16 [1.3] 11 [1.2] 9 [1.1] 6 [1.0] Mediastinum, Hemorrhage 1 [3.0] Serosa, Inflammation, Chronic Active 1 [3.0] Nose (53) (54) (53) (53) (53) (51) Cyst 1 [3.0] Inflammation 1 [1.0] 6 [2.0] 3 [2.0] 6 [1.5] 6 [1.8] 3 [2.0] Goblet Cell, Hyperplasia 2 [2.5] 1 [2.0] 2 [2.0] Nasolacrimal Duct, Inflammation 2 [3.0] 2 [2.5] Respiratory Epithelium, Hyperplasia 2 [2.0] 1 [2.0] Respiratory Epithelium, Mineralization 1 [2.0] Septum, Inflammation 4 [1.5] 3 [2.0] 5 [1.8] 3 [1.0] 7 [1.4] 6 [1.5] Squamous Epithelium, Hyperplasia 1 [2.0] Turbinate, Inflammation 8 [1.1] 3 [1.7] 5 [1.4] 9 [1.4] 10 [1.7] 10 [1.5] Trachea (52) (54) (53) (53) (53) (51) Inflammation 1 [2.0] ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (53) (54) (53) (53) (52) (51) Degeneration 1 [3.0] Anterior Chamber, Exudate 1 [2.0] Lens, Degeneration 1 [1.0] Retina, Atrophy 2 [1.5] 1 [1.0] 1 [1.0] Harderian Gland (53) (54) (53) (53) (53) (49) Atrophy 1 [1.0] Inflammation 20 [1.0] 9 [1.1] 13 [1.1] 16 [1.1] 16 [1.1] 16 [1.2] ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (53) (54) (53) (53) (53) (51) Accumulation, Hyaline Droplet 3 [2.0] 1 [3.0] 1 [1.0] Calculus Micro Observation Only 3 5 4 7 5 1 Casts Protein 3 [1.0] 2 [1.5] 2 [1.0] 1 [2.0] 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 8 NTP Experiment-Test: 96021-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18 Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 10/09/03 Route: GAVAGE TOXIC EQUIVALENCY FACTOR EVALUATION (PCB 153) Time: 10:00:49 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 0 UG/KG 10 UG/KG 100 300 1000 3000 UG/KG UG/KG UG/KG UG/KG ____________________________________________________________________________________________________________________________________ URINARY SYSTEM - CONT Cyst 1 [2.0] 1 [2.0] Degeneration 1 [2.0] Hydronephrosis 1 [3.0] 1 [3.0] Infarct 1 [3.0] 1 [3.0] 2 [2.5] Inflammation, Chronic Active 2 [1.0] 3 [1.7] 1 [1.0] Inflammation, Suppurative 1 [1.0] 2 [2.0] 3 [1.0] 2 [1.0] 2 [1.0] 3 [2.0] Mineralization 40 [1.1] 42 [1.1] 41 [1.0] 39 [1.1] 40 [1.1] 41 [1.0] Necrosis 1 [3.0] Nephropathy 34 [1.1] 23 [1.1] 24 [1.0] 33 [1.1] 28 [1.2] 34 [1.1] Pelvis, Dilatation 2 [2.5] Pelvis, Inflammation 1 [2.0] 4 [2.0] 2 [2.5] 4 [2.3] 5 [1.8] 4 [2.0] Renal Tubule, Degeneration 1 [3.0] 1 [3.0] Renal Tubule, Hyperplasia 1 [2.0] Transitional Epithelium, Hyperplasia 1 [2.0] 5 [1.8] 2 [2.5] 4 [2.0] 6 [1.8] 4 [2.3] Ureter (1) Cyst 1 [3.0] Urinary Bladder (53) (53) (53) (53) (53) (50) Calculus Micro Observation Only 1 Inflammation 8 [1.1] 11 [1.6] 6 [1.7] 8 [2.0] 13 [1.2] 9 [1.9] Transitional Epithelium, Hyperplasia 3 [2.3] 2 [2.5] 3 [2.0] 2 [2.0] 3 [2.3] 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: 96021-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18 Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 10/09/03 Route: GAVAGE TOXIC EQUIVALENCY FACTOR EVALUATION (PCB 153) Time: 10:00:49 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 3000 UG/ KG STOP ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 50 Early Deaths Natural Death 14 Moribund Sacrifice 16 Survivors Terminal Sacrifice 20 Animals Examined Microscopically 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Esophagus (49) Muscularis, Inflammation 3 [1.3] Intestine Large, Rectum (50) Parasite Metazoan 3 Intestine Large, Cecum (48) Inflammation 1 [3.0] Ulcer 1 [3.0] Liver (50) Angiectasis 8 [1.6] Basophilic Focus 8 Basophilic Focus, Multiple 2 Clear Cell Focus 1 Degeneration, Cystic 1 [2.0] Eosinophilic Focus 4 Eosinophilic Focus, Multiple 10 Fatty Change, Diffuse 15 [1.1] Fatty Change, Focal 6 [1.2] Hematopoietic Cell Proliferation 17 [1.2] Hepatodiaphragmatic Nodule 2 Hyperplasia, Histiocytic 1 [2.0] Hyperplasia, Nodular 1 Inflammation 44 [1.1] Mixed Cell Focus 7 Mixed Cell Focus, Multiple 13 Necrosis 9 [2.7] Pigmentation 3 [1.3] Bile Duct, Cyst 3 [2.0] Bile Duct, Fibrosis 5 [1.2] Bile Duct, Hyperplasia 12 [1.7] Centrilobular, Degeneration 5 [2.2] 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: 96021-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18 Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 10/09/03 Route: GAVAGE TOXIC EQUIVALENCY FACTOR EVALUATION (PCB 153) Time: 10:00:49 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 3000 UG/ KG STOP ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Hepatocyte, Hypertrophy 32 [1.8] Oval Cell, Hyperplasia 2 [1.0] Oral Mucosa (15) Gingival, Hyperplasia, Squamous 15 [1.1] Pancreas (50) Inflammation, Chronic Active 2 [1.0] Acinus, Atrophy 3 [2.0] Acinus, Hyperplasia 2 [2.0] Acinus, Vacuolization Cytoplasmic 1 [2.0] Salivary Glands (48) Inflammation, Chronic Active 1 [2.0] Stomach, Forestomach (50) Hyperkeratosis 2 [2.0] Hyperplasia, Squamous 5 [2.0] Inflammation 4 [1.5] Mineralization 3 [1.7] Stomach, Glandular (50) Inflammation 1 [3.0] Mineralization 3 [1.3] Ulcer 1 [3.0] Serosa, Inflammation 1 [2.0] Tooth (27) Peridontal Tissue, Inflammation 27 [1.4] ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (50) Cardiomyopathy 15 [1.1] Epicardium, Inflammation 1 [1.0] ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (50) Angiectasis 20 [1.7] Degeneration, Cystic 7 [1.7] Hematopoietic Cell Proliferation 2 [1.5] Hyperplasia 18 [2.3] Hypertrophy 35 [1.8] Necrosis 1 [2.0] Vacuolization Cytoplasmic 12 [1.1] Adrenal Medulla (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 11 NTP Experiment-Test: 96021-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18 Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 10/09/03 Route: GAVAGE TOXIC EQUIVALENCY FACTOR EVALUATION (PCB 153) Time: 10:00:49 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 3000 UG/ KG STOP ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM - CONT Angiectasis 1 [2.0] Hyperplasia 19 [2.2] Parathyroid Gland (45) Hyperplasia 1 [2.0] Pituitary Gland (50) Angiectasis 24 [2.3] Pars Distalis, Hyperplasia 18 [2.4] Rathke's Cleft, Pars Nervosa, Cyst 1 [2.0] Thyroid Gland (49) C-Cell, Hyperplasia 13 [1.9] Follicular Cell, Hypertrophy 12 [1.8] ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Clitoral Gland (48) Inflammation 44 [1.5] Duct, Cyst 41 [2.3] Ovary (49) Atrophy 41 [3.9] Cyst 16 [2.4] Oviduct (46) Dilatation 1 [3.0] Inflammation, Chronic Active 2 [3.0] Uterus (49) Cyst 1 [4.0] Inflammation, Chronic Active 1 [3.0] Inflammation, Suppurative 9 [2.2] Metaplasia, Squamous 24 [2.7] Cervix, Cyst 1 [3.0] Cervix, Hyperplasia, Stromal 2 [3.0] Endometrium, Hyperplasia, Cystic 23 [1.8] Vagina (1) Inflammation, Chronic Active 1 [3.0] ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM 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: 96021-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18 Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 10/09/03 Route: GAVAGE TOXIC EQUIVALENCY FACTOR EVALUATION (PCB 153) Time: 10:00:49 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 3000 UG/ KG STOP ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - CONT Bone Marrow (50) Hyperplasia 40 [3.1] Lymph Node (1) Mediastinal, Hemorrhage 1 [2.0] Lymph Node, Mandibular (48) Ectasia 1 [2.0] Hyperplasia, Lymphoid 1 [3.0] Hyperplasia, Plasma Cell 37 [2.5] Inflammation 1 [3.0] Spleen (50) Accessory Spleen 1 Congestion 1 [3.0] Hematopoietic Cell Proliferation 44 [1.9] Hemorrhage 1 [2.0] Pigmentation 50 [1.3] Lymphoid Follicle, Atrophy 4 [2.3] Thymus (49) Atrophy 29 [2.4] Hemorrhage 1 [3.0] Inflammation 1 [3.0] Necrosis, Lymphoid 1 [2.0] ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (50) Cyst 3 [2.3] Cyst, Multiple 1 [3.0] Hyperplasia 27 [1.5] Inflammation, Granulomatous 2 [1.5] Skin (50) Ulcer 1 [4.0] ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM None ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM None ____________________________________________________________________________________________________________________________________ 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 NTP Experiment-Test: 96021-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18 Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 10/09/03 Route: GAVAGE TOXIC EQUIVALENCY FACTOR EVALUATION (PCB 153) Time: 10:00:49 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 3000 UG/ KG STOP ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) Hemorrhage 1 [2.0] Infiltration Cellular, Histiocyte 37 [1.3] Inflammation 9 [1.8] Alveolar Epithelium, Hyperplasia 4 [1.3] Nose (50) Inflammation 2 [1.5] Septum, Inflammation 4 [1.3] Turbinate, Inflammation 5 [1.2] ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (50) Retina, Atrophy 2 [2.0] Harderian Gland (50) Inflammation 15 [1.2] ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) Casts Protein 4 [1.0] Cyst 1 [2.0] Fibrosis 1 [1.0] Inflammation, Chronic Active 3 [2.7] Inflammation, Suppurative 2 [2.0] Mineralization 38 [1.0] Nephropathy 22 [1.2] Pelvis, Inflammation 3 [1.3] Transitional Epithelium, Hyperplasia 4 [1.5] Urinary Bladder (49) Inflammation 10 [1.7] Transitional Epithelium, Hyperplasia 3 [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 14 ------------------------------------------------------------ ---------- END OF REPORT ---------- ------------------------------------------------------------