TDMS Study 96021-01 Pathology Tables
NTP Experiment-Test: 96021-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION (PCB 153) Date: 10/09/03 Route: GAVAGE Time: 09:34:31 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 Page 1 NTP Experiment-Test: 96021-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION (PCB 153) Date: 10/09/03 Route: GAVAGE Time: 09:34:31 ____________________________________________________________________________________________________________________________________ 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 (6%) 1 (2%) 2 (4%) 1 (2%) Periesophageal Tissue, Hemorrhage 1 (2%) Periesophageal Tissue, Inflammation 1 (2%) Intestine Large, Colon (53) (54) (53) (53) (53) (50) Inflammation, Chronic Active 1 (2%) Parasite Metazoan 1 (2%) 1 (2%) 1 (2%) 2 (4%) Intestine Large, Rectum (53) (54) (53) (53) (53) (50) Inflammation, Chronic Active 1 (2%) Parasite Metazoan 1 (2%) 2 (4%) 3 (6%) 7 (13%) 5 (9%) 5 (10%) Intestine Large, Cecum (53) (54) (53) (53) (53) (50) Inflammation, Chronic Active 1 (2%) Intestine Small, Duodenum (53) (54) (53) (53) (53) (51) Parasite Metazoan 1 (2%) Intestine Small, Jejunum (53) (54) (53) (53) (53) (50) Peyer's Patch, Hyperplasia, Lymphoid 1 (2%) 1 (2%) Intestine Small, Ileum (52) (54) (53) (53) (53) (50) Hyperplasia, Lymphoid 1 (2%) Liver (53) (54) (53) (53) (53) (51) Angiectasis 5 (9%) 2 (4%) 2 (4%) 1 (2%) 8 (15%) 4 (8%) Basophilic Focus 8 (15%) 5 (9%) 16 (30%) 6 (11%) 3 (6%) 8 (16%) Basophilic Focus, Multiple 8 (15%) 12 (22%) 9 (17%) 7 (13%) 7 (13%) 2 (4%) Cholangiofibrosis 1 (2%) Clear Cell Focus 3 (6%) 3 (6%) 4 (8%) 2 (4%) Clear Cell Focus, Multiple 3 (6%) 2 (4%) 1 (2%) Eosinophilic Focus 5 (9%) 1 (2%) 8 (15%) 7 (13%) 14 (26%) 6 (12%) Eosinophilic Focus, Multiple 7 (13%) 1 (2%) 8 (15%) 12 (23%) 9 (17%) 12 (24%) Fatty Change, Diffuse 3 (6%) 7 (13%) 2 (4%) 11 (21%) 21 (40%) 17 (33%) a Number of animals examined microscopically at site and number of animals with lesion Page 2 NTP Experiment-Test: 96021-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION (PCB 153) Date: 10/09/03 Route: GAVAGE Time: 09:34:31 ____________________________________________________________________________________________________________________________________ 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 (8%) 3 (6%) 5 (9%) 4 (8%) 1 (2%) Hematopoietic Cell Proliferation 20 (38%) 22 (41%) 13 (25%) 18 (34%) 16 (30%) 14 (27%) Hepatodiaphragmatic Nodule 1 (2%) 1 (2%) Hyperplasia, Nodular 1 (2%) Inflammation 44 (83%) 39 (72%) 44 (83%) 47 (89%) 48 (91%) 45 (88%) Mixed Cell Focus 8 (15%) 3 (6%) 7 (13%) 6 (11%) 5 (9%) 3 (6%) Mixed Cell Focus, Multiple 21 (40%) 16 (30%) 22 (42%) 19 (36%) 19 (36%) 12 (24%) Necrosis 7 (13%) 7 (13%) 7 (13%) 5 (9%) 12 (23%) 10 (20%) Pigmentation 1 (2%) 1 (2%) 2 (4%) 5 (9%) 5 (9%) 9 (18%) Bile Duct, Cyst 3 (6%) 2 (4%) 2 (4%) 3 (6%) 5 (9%) 2 (4%) Bile Duct, Fibrosis 2 (4%) 1 (2%) 2 (4%) 2 (4%) 2 (4%) 3 (6%) Bile Duct, Hyperplasia 5 (9%) 3 (6%) 2 (4%) 14 (26%) 10 (19%) 17 (33%) Centrilobular, Degeneration 2 (4%) 10 (19%) 4 (8%) 2 (4%) 2 (4%) 5 (10%) Hepatocyte, Hypertrophy 5 (9%) 5 (9%) 24 (45%) 39 (74%) 41 (80%) Oval Cell, Hyperplasia 1 (2%) 4 (8%) Serosa, Fibrosis 1 (2%) Serosa, Inflammation 2 (4%) Mesentery (1) (1) Fat, Inflammation, Chronic Active 1 (100%) Oral Mucosa (21) (12) (16) (12) (16) (25) Gingival, Hyperplasia, Squamous 21 (100%) 10 (83%) 16 (100%) 11 (92%) 16 (100%) 25 (100%) Pancreas (53) (54) (53) (53) (53) (51) Cyst 1 (2%) Degeneration 1 (2%) Inflammation, Chronic Active 2 (4%) 1 (2%) 1 (2%) 2 (4%) Acinus, Atrophy 1 (2%) 1 (2%) 1 (2%) 2 (4%) Acinus, Hyperplasia 3 (6%) Acinus, Vacuolization Cytoplasmic 1 (2%) 1 (2%) 2 (4%) Salivary Glands (51) (52) (53) (52) (53) (51) Ectopic Tissue 1 (2%) Stomach, Forestomach (53) (54) (53) (53) (53) (51) Hyperkeratosis 1 (2%) 1 (2%) 2 (4%) Hyperplasia, Squamous 3 (6%) 4 (7%) 2 (4%) 6 (11%) 4 (8%) 4 (8%) Inflammation 3 (6%) 3 (6%) 2 (4%) Mineralization 1 (2%) 2 (4%) 2 (4%) Ulcer 2 (4%) 3 (6%) 1 (2%) Serosa, Inflammation, Chronic Active 1 (2%) Stomach, Glandular (53) (54) (53) (53) (53) (51) Erosion 1 (2%) 1 (2%) 2 (4%) Inflammation 2 (4%) Mineralization 5 (9%) 8 (15%) 8 (15%) 10 (19%) 10 (19%) 2 (4%) Tooth (34) (13) (19) (22) (23) (35) Degeneration 1 (3%) a Number of animals examined microscopically at site and number of animals with lesion Page 3 NTP Experiment-Test: 96021-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION (PCB 153) Date: 10/09/03 Route: GAVAGE Time: 09:34:31 ____________________________________________________________________________________________________________________________________ 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 (97%) 13 (100%) 19 (100%) 21 (95%) 23 (100%) 35 (100%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Blood Vessel (52) (54) (53) (53) (53) (51) Aorta, Mineralization 2 (4%) 1 (2%) 1 (2%) 1 (2%) Heart (52) (54) (53) (53) (53) (51) Cardiomyopathy 22 (42%) 18 (33%) 19 (36%) 19 (36%) 23 (43%) 24 (47%) Inflammation 2 (4%) 1 (2%) 1 (2%) Mineralization 1 (2%) 1 (2%) Necrosis 1 (2%) Thrombosis 2 (4%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (53) (54) (53) (53) (53) (51) Angiectasis 21 (40%) 23 (43%) 34 (64%) 25 (47%) 29 (55%) 21 (41%) Atrophy 1 (2%) 2 (4%) Degeneration, Cystic 9 (17%) 12 (22%) 15 (28%) 13 (25%) 12 (23%) 13 (25%) Hematopoietic Cell Proliferation 1 (2%) 1 (2%) 3 (6%) Hyperplasia 18 (34%) 24 (44%) 27 (51%) 27 (51%) 28 (53%) 11 (22%) Hypertrophy 48 (91%) 35 (65%) 45 (85%) 35 (66%) 42 (79%) 41 (80%) Inflammation 1 (2%) 1 (2%) Mineralization 2 (4%) 1 (2%) Necrosis 1 (2%) 2 (4%) 1 (2%) 2 (4%) 3 (6%) 3 (6%) Vacuolization Cytoplasmic 10 (19%) 8 (15%) 14 (26%) 16 (30%) 12 (23%) 14 (27%) Adrenal Medulla (53) (54) (53) (53) (53) (51) Angiectasis 1 (2%) 1 (2%) Hyperplasia 18 (34%) 14 (26%) 19 (36%) 14 (26%) 20 (38%) 12 (24%) Islets, Pancreatic (53) (54) (53) (53) (53) (51) Hyperplasia 1 (2%) 1 (2%) 1 (2%) Parathyroid Gland (49) (46) (50) (47) (46) (48) Angiectasis 1 (2%) Cyst 1 (2%) Fibrosis 1 (2%) Hyperplasia 2 (4%) 1 (2%) 1 (2%) Pituitary Gland (53) (54) (53) (53) (53) (50) Angiectasis 15 (28%) 16 (30%) 20 (38%) 26 (49%) 28 (53%) 14 (28%) Atypia Cellular 1 (2%) Cyst 1 (2%) 1 (2%) Cytoplasmic Alteration 2 (4%) 1 (2%) 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 4 NTP Experiment-Test: 96021-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION (PCB 153) Date: 10/09/03 Route: GAVAGE Time: 09:34:31 ____________________________________________________________________________________________________________________________________ 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 (2%) Pars Distalis, Hyperplasia 23 (43%) 18 (33%) 22 (42%) 16 (30%) 23 (43%) 25 (50%) Thyroid Gland (51) (52) (53) (53) (53) (51) Angiectasis 1 (2%) 1 (2%) C-Cell, Hyperplasia 19 (37%) 17 (33%) 23 (43%) 17 (32%) 19 (36%) 16 (31%) Follicular Cell, Hyperplasia 1 (2%) 2 (4%) 2 (4%) Follicular Cell, Hypertrophy 5 (10%) 9 (17%) 9 (17%) 12 (23%) 10 (19%) 17 (33%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Clitoral Gland (53) (51) (52) (53) (51) (50) Atrophy 1 (2%) Inflammation 52 (98%) 45 (88%) 41 (79%) 48 (91%) 48 (94%) 46 (92%) Inflammation, Chronic Active 1 (2%) Duct, Cyst 49 (92%) 40 (78%) 36 (69%) 43 (81%) 45 (88%) 41 (82%) Ovary (53) (53) (53) (53) (53) (50) Atrophy 47 (89%) 43 (81%) 42 (79%) 38 (72%) 44 (83%) 39 (78%) Cyst 14 (26%) 7 (13%) 17 (32%) 17 (32%) 16 (30%) 17 (34%) Inflammation, Chronic Active 2 (4%) 1 (2%) 5 (9%) 7 (14%) Necrosis 1 (2%) Interstitial Cell, Hyperplasia 1 (2%) 1 (2%) Oviduct (50) (38) (44) (35) (39) (45) Cyst 1 (3%) 2 (5%) 1 (3%) 1 (3%) Dilatation 1 (2%) 1 (2%) Inflammation, Chronic Active 1 (2%) 2 (5%) 1 (3%) 5 (13%) 7 (16%) Uterus (53) (54) (53) (53) (53) (50) Adenomyosis 2 (4%) 1 (2%) 1 (2%) 1 (2%) Angiectasis 1 (2%) 1 (2%) Congestion 1 (2%) Cyst 1 (2%) 1 (2%) Hemorrhage 2 (4%) Inflammation, Chronic Active 2 (4%) 1 (2%) 5 (9%) 4 (8%) 2 (4%) 8 (16%) Inflammation, Suppurative 5 (9%) 6 (11%) 6 (11%) 2 (4%) 16 (30%) 8 (16%) Metaplasia, Squamous 23 (43%) 29 (54%) 27 (51%) 17 (32%) 27 (51%) 32 (64%) Thrombosis 1 (2%) 2 (4%) Ulcer 1 (2%) Cervix, Hyperplasia, Stromal 1 (2%) 2 (4%) a Number of animals examined microscopically at site and number of animals with lesion Page 5 NTP Experiment-Test: 96021-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION (PCB 153) Date: 10/09/03 Route: GAVAGE Time: 09:34:31 ____________________________________________________________________________________________________________________________________ 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 (2%) Endometrium, Hyperplasia, Cystic 37 (70%) 29 (54%) 32 (60%) 28 (53%) 25 (47%) 21 (42%) Endometrium, Hyperplasia, Stromal 1 (2%) Vagina (1) (3) (2) (1) (1) (3) Inflammation 1 (50%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (53) (54) (53) (53) (53) (51) Hyperplasia 34 (64%) 41 (76%) 40 (75%) 38 (72%) 42 (79%) 46 (90%) Lymph Node (3) (3) (3) (2) (5) (6) Hemorrhage 1 (33%) Hyperplasia, Lymphoid 1 (33%) Hyperplasia, Plasma Cell 1 (33%) 1 (33%) Iliac, Ectasia 1 (20%) Iliac, Hyperplasia, Plasma Cell 1 (20%) Lumbar, Ectasia 1 (33%) 2 (67%) 2 (33%) Lumbar, Hemorrhage 1 (33%) 1 (17%) Lumbar, Hyperplasia, Histiocytic 1 (20%) Lumbar, Hyperplasia, Plasma Cell 1 (20%) 2 (33%) Mediastinal, Congestion 3 (100%) Mediastinal, Ectasia 2 (33%) Mediastinal, Hyperplasia, Histiocytic 1 (33%) Mediastinal, Hyperplasia, Lymphoid 1 (33%) 1 (33%) Mediastinal, Hyperplasia, Plasma Cell 1 (33%) 1 (33%) Renal, Ectasia 2 (33%) Renal, Hyperplasia, Plasma Cell 1 (17%) Renal, Inflammation, Chronic Active 1 (50%) Lymph Node, Mandibular (51) (52) (53) (51) (53) (51) Congestion 1 (2%) Ectasia 1 (2%) 1 (2%) 1 (2%) Hemorrhage 1 (2%) Hyperplasia, Lymphoid 1 (2%) 1 (2%) 2 (4%) 1 (2%) 3 (6%) 1 (2%) Hyperplasia, Plasma Cell 37 (73%) 36 (69%) 30 (57%) 33 (65%) 37 (70%) 38 (75%) Inflammation 1 (2%) Lymph Node, Mesenteric (52) (54) (53) (53) (53) (51) Ectasia 1 (2%) Hemorrhage 1 (2%) Hyperplasia, Plasma Cell 1 (2%) Inflammation, Chronic Active 1 (2%) Spleen (53) (54) (53) (53) (53) (51) Hematopoietic Cell Proliferation 46 (87%) 48 (89%) 52 (98%) 48 (91%) 46 (87%) 47 (92%) a Number of animals examined microscopically at site and number of animals with lesion Page 6 NTP Experiment-Test: 96021-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION (PCB 153) Date: 10/09/03 Route: GAVAGE Time: 09:34:31 ____________________________________________________________________________________________________________________________________ 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 (2%) Infarct 1 (2%) Necrosis 1 (2%) 1 (2%) 1 (2%) Pigmentation 47 (89%) 42 (78%) 47 (89%) 49 (92%) 49 (92%) 46 (90%) Lymphoid Follicle, Atrophy 1 (2%) 6 (11%) 2 (4%) 3 (6%) 3 (6%) 3 (6%) Red Pulp, Atrophy 2 (4%) Thymus (48) (53) (52) (53) (53) (47) Atrophy 38 (79%) 38 (72%) 37 (71%) 35 (66%) 41 (77%) 30 (64%) Cyst 1 (2%) 1 (2%) Hemorrhage 3 (6%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (53) (54) (53) (53) (53) (51) Cyst 2 (4%) 1 (2%) 2 (4%) 1 (2%) 3 (6%) Hyperplasia 22 (42%) 23 (43%) 32 (60%) 27 (51%) 32 (60%) 22 (43%) Inflammation, Chronic Active 1 (2%) Inflammation, Granulomatous 2 (4%) 2 (4%) 3 (6%) 1 (2%) Skin (53) (54) (53) (53) (53) (51) Cyst 1 (2%) Cyst Epithelial Inclusion 1 (2%) 1 (2%) Inflammation 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM None ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (53) (54) (53) (53) (53) (51) Hemorrhage 1 (2%) 1 (2%) 1 (2%) 2 (4%) Hydrocephalus 2 (4%) 1 (2%) Hyperplasia, Histiocytic 1 (2%) Mineralization 1 (2%) Necrosis 1 (2%) 1 (2%) Vacuolization Cytoplasmic 1 (2%) Glial Cell, Hyperplasia 1 (2%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 7 NTP Experiment-Test: 96021-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION (PCB 153) Date: 10/09/03 Route: GAVAGE Time: 09:34:31 ____________________________________________________________________________________________________________________________________ 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%) Hemorrhage 1 (2%) 1 (2%) Infiltration Cellular, Histiocyte 45 (87%) 40 (74%) 40 (75%) 40 (75%) 27 (51%) 28 (55%) Inflammation 6 (12%) 7 (13%) 2 (4%) 6 (11%) 7 (13%) 9 (18%) Metaplasia, Squamous 1 (2%) 1 (2%) 1 (2%) Mineralization 1 (2%) 1 (2%) Alveolar Epithelium, Hyperplasia 20 (38%) 21 (39%) 16 (30%) 11 (21%) 9 (17%) 6 (12%) Mediastinum, Hemorrhage 1 (2%) Serosa, Inflammation, Chronic Active 1 (2%) Nose (53) (54) (53) (53) (53) (51) Cyst 1 (2%) Inflammation 1 (2%) 6 (11%) 3 (6%) 6 (11%) 6 (11%) 3 (6%) Goblet Cell, Hyperplasia 2 (4%) 1 (2%) 2 (4%) Nasolacrimal Duct, Inflammation 2 (4%) 2 (4%) Respiratory Epithelium, Hyperplasia 2 (4%) 1 (2%) Respiratory Epithelium, Mineralization 1 (2%) Septum, Inflammation 4 (8%) 3 (6%) 5 (9%) 3 (6%) 7 (13%) 6 (12%) Squamous Epithelium, Hyperplasia 1 (2%) Turbinate, Inflammation 8 (15%) 3 (6%) 5 (9%) 9 (17%) 10 (19%) 10 (20%) Trachea (52) (54) (53) (53) (53) (51) Inflammation 1 (2%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (53) (54) (53) (53) (52) (51) Degeneration 1 (2%) Anterior Chamber, Exudate 1 (2%) Lens, Degeneration 1 (2%) Retina, Atrophy 2 (4%) 1 (2%) 1 (2%) Harderian Gland (53) (54) (53) (53) (53) (49) Atrophy 1 (2%) Inflammation 20 (38%) 9 (17%) 13 (25%) 16 (30%) 16 (30%) 16 (33%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (53) (54) (53) (53) (53) (51) Accumulation, Hyaline Droplet 3 (6%) 1 (2%) 1 (2%) Calculus Micro Observation Only 3 (6%) 5 (9%) 4 (8%) 7 (13%) 5 (9%) 1 (2%) Casts Protein 3 (6%) 2 (4%) 2 (4%) 1 (2%) 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 8 NTP Experiment-Test: 96021-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION (PCB 153) Date: 10/09/03 Route: GAVAGE Time: 09:34:31 ____________________________________________________________________________________________________________________________________ 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%) 1 (2%) Degeneration 1 (2%) Hydronephrosis 1 (2%) 1 (2%) Infarct 1 (2%) 1 (2%) 2 (4%) Inflammation, Chronic Active 2 (4%) 3 (6%) 1 (2%) Inflammation, Suppurative 1 (2%) 2 (4%) 3 (6%) 2 (4%) 2 (4%) 3 (6%) Mineralization 40 (75%) 42 (78%) 41 (77%) 39 (74%) 40 (75%) 41 (80%) Necrosis 1 (2%) Nephropathy 34 (64%) 23 (43%) 24 (45%) 33 (62%) 28 (53%) 34 (67%) Pelvis, Dilatation 2 (4%) Pelvis, Inflammation 1 (2%) 4 (7%) 2 (4%) 4 (8%) 5 (9%) 4 (8%) Renal Tubule, Degeneration 1 (2%) 1 (2%) Renal Tubule, Hyperplasia 1 (2%) Transitional Epithelium, Hyperplasia 1 (2%) 5 (9%) 2 (4%) 4 (8%) 6 (11%) 4 (8%) Ureter (1) Cyst 1 (100%) Urinary Bladder (53) (53) (53) (53) (53) (50) Calculus Micro Observation Only 1 (2%) Inflammation 8 (15%) 11 (21%) 6 (11%) 8 (15%) 13 (25%) 9 (18%) Transitional Epithelium, Hyperplasia 3 (6%) 2 (4%) 3 (6%) 2 (4%) 3 (6%) a Number of animals examined microscopically at site and number of animals with lesion Page 9 NTP Experiment-Test: 96021-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION (PCB 153) Date: 10/09/03 Route: GAVAGE Time: 09:34:31 ____________________________________________________________________________________________________________________________________ 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 (6%) Intestine Large, Rectum (50) Parasite Metazoan 3 (6%) Intestine Large, Cecum (48) Inflammation 1 (2%) Ulcer 1 (2%) Liver (50) Angiectasis 8 (16%) Basophilic Focus 8 (16%) Basophilic Focus, Multiple 2 (4%) Clear Cell Focus 1 (2%) Degeneration, Cystic 1 (2%) Eosinophilic Focus 4 (8%) Eosinophilic Focus, Multiple 10 (20%) Fatty Change, Diffuse 15 (30%) Fatty Change, Focal 6 (12%) Hematopoietic Cell Proliferation 17 (34%) Hepatodiaphragmatic Nodule 2 (4%) Hyperplasia, Histiocytic 1 (2%) Hyperplasia, Nodular 1 (2%) Inflammation 44 (88%) Mixed Cell Focus 7 (14%) Mixed Cell Focus, Multiple 13 (26%) Necrosis 9 (18%) Pigmentation 3 (6%) Bile Duct, Cyst 3 (6%) Bile Duct, Fibrosis 5 (10%) Bile Duct, Hyperplasia 12 (24%) Centrilobular, Degeneration 5 (10%) a Number of animals examined microscopically at site and number of animals with lesion Page 10 NTP Experiment-Test: 96021-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION (PCB 153) Date: 10/09/03 Route: GAVAGE Time: 09:34:31 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 3000 UG/ KG STOP ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Hepatocyte, Hypertrophy 32 (64%) Oval Cell, Hyperplasia 2 (4%) Oral Mucosa (15) Gingival, Hyperplasia, Squamous 15 (100%) Pancreas (50) Inflammation, Chronic Active 2 (4%) Acinus, Atrophy 3 (6%) Acinus, Hyperplasia 2 (4%) Acinus, Vacuolization Cytoplasmic 1 (2%) Salivary Glands (48) Inflammation, Chronic Active 1 (2%) Stomach, Forestomach (50) Hyperkeratosis 2 (4%) Hyperplasia, Squamous 5 (10%) Inflammation 4 (8%) Mineralization 3 (6%) Stomach, Glandular (50) Inflammation 1 (2%) Mineralization 3 (6%) Ulcer 1 (2%) Serosa, Inflammation 1 (2%) Tooth (27) Peridontal Tissue, Inflammation 27 (100%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (50) Cardiomyopathy 15 (30%) Epicardium, Inflammation 1 (2%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (50) Angiectasis 20 (40%) Degeneration, Cystic 7 (14%) Hematopoietic Cell Proliferation 2 (4%) Hyperplasia 18 (36%) Hypertrophy 35 (70%) Necrosis 1 (2%) Vacuolization Cytoplasmic 12 (24%) Adrenal Medulla (50) a Number of animals examined microscopically at site and number of animals with lesion Page 11 NTP Experiment-Test: 96021-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION (PCB 153) Date: 10/09/03 Route: GAVAGE Time: 09:34:31 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 3000 UG/ KG STOP ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM - CONT Angiectasis 1 (2%) Hyperplasia 19 (38%) Parathyroid Gland (45) Hyperplasia 1 (2%) Pituitary Gland (50) Angiectasis 24 (48%) Pars Distalis, Hyperplasia 18 (36%) Rathke's Cleft, Pars Nervosa, Cyst 1 (2%) Thyroid Gland (49) C-Cell, Hyperplasia 13 (27%) Follicular Cell, Hypertrophy 12 (24%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Clitoral Gland (48) Inflammation 44 (92%) Duct, Cyst 41 (85%) Ovary (49) Atrophy 41 (84%) Cyst 16 (33%) Oviduct (46) Dilatation 1 (2%) Inflammation, Chronic Active 2 (4%) Uterus (49) Cyst 1 (2%) Inflammation, Chronic Active 1 (2%) Inflammation, Suppurative 9 (18%) Metaplasia, Squamous 24 (49%) Cervix, Cyst 1 (2%) Cervix, Hyperplasia, Stromal 2 (4%) Endometrium, Hyperplasia, Cystic 23 (47%) Vagina (1) Inflammation, Chronic Active 1 (100%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM a Number of animals examined microscopically at site and number of animals with lesion Page 12 NTP Experiment-Test: 96021-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION (PCB 153) Date: 10/09/03 Route: GAVAGE Time: 09:34:31 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 3000 UG/ KG STOP ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - CONT Bone Marrow (50) Hyperplasia 40 (80%) Lymph Node (1) Mediastinal, Hemorrhage 1 (100%) Lymph Node, Mandibular (48) Ectasia 1 (2%) Hyperplasia, Lymphoid 1 (2%) Hyperplasia, Plasma Cell 37 (77%) Inflammation 1 (2%) Spleen (50) Accessory Spleen 1 (2%) Congestion 1 (2%) Hematopoietic Cell Proliferation 44 (88%) Hemorrhage 1 (2%) Pigmentation 50 (100%) Lymphoid Follicle, Atrophy 4 (8%) Thymus (49) Atrophy 29 (59%) Hemorrhage 1 (2%) Inflammation 1 (2%) Necrosis, Lymphoid 1 (2%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (50) Cyst 3 (6%) Cyst, Multiple 1 (2%) Hyperplasia 27 (54%) Inflammation, Granulomatous 2 (4%) Skin (50) Ulcer 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM None ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM None ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 13 NTP Experiment-Test: 96021-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION (PCB 153) Date: 10/09/03 Route: GAVAGE Time: 09:34:31 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 3000 UG/ KG STOP ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) Hemorrhage 1 (2%) Infiltration Cellular, Histiocyte 37 (74%) Inflammation 9 (18%) Alveolar Epithelium, Hyperplasia 4 (8%) Nose (50) Inflammation 2 (4%) Septum, Inflammation 4 (8%) Turbinate, Inflammation 5 (10%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (50) Retina, Atrophy 2 (4%) Harderian Gland (50) Inflammation 15 (30%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) Casts Protein 4 (8%) Cyst 1 (2%) Fibrosis 1 (2%) Inflammation, Chronic Active 3 (6%) Inflammation, Suppurative 2 (4%) Mineralization 38 (76%) Nephropathy 22 (44%) Pelvis, Inflammation 3 (6%) Transitional Epithelium, Hyperplasia 4 (8%) Urinary Bladder (49) Inflammation 10 (20%) Transitional Epithelium, Hyperplasia 3 (6%) a Number of animals examined microscopically at site and number of animals with lesion Page 14 ------------------------------------------------------------ ---------- END OF REPORT ---------- ------------------------------------------------------------