TDMS Study 96020-01 Pathology Tables
NTP Experiment-Test: 96020-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC TEF EVALUATION (BINARY MIXTURE; PCB 126/PCB 153) Date: 03/03/04 Route: GAVAGE Time: 09:44:17 FINAL #1 Facility: Battelle Columbus Laboratory Chemical CAS #: TEFBINARYMIX Lock Date: 03/27/02 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 001 0 NG / 0 UG Include 004 300 NG /100 UG Include 005 300 NG /300 UG Include 006 300 NG /3000 UG a Number of animals examined microscopically at site and number of animals with lesion Page 1 NTP Experiment-Test: 96020-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC TEF EVALUATION (BINARY MIXTURE; PCB 126/PCB 153) Date: 03/03/04 Route: GAVAGE Time: 09:44:17 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 0 NG / 300 NG / 300 NG / 300 NG / 0 UG 100 UG 300 UG 3000 UG ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 98 80 98 80 Early Deaths Moribund Sacrifice 22 10 19 13 Natural Death 8 12 10 10 Dosing Accident 1 1 Survivors Terminal Sacrifice 22 28 24 27 Animals Examined Microscopically 53 50 53 51 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Esophagus (53) (50) (53) (50) Perforation 1 (2%) Muscularis, Inflammation 3 (6%) 3 (6%) Periesophageal Tissue, Hemorrhage 1 (2%) Periesophageal Tissue, Inflammation 1 (2%) 1 (2%) Intestine Large, Rectum (53) (50) (53) (51) Parasite Metazoan 2 (4%) 1 (2%) 1 (2%) 2 (4%) Artery, Inflammation, Chronic Active 1 (2%) 2 (4%) Intestine Large, Cecum (53) (50) (52) (50) Edema 1 (2%) Inflammation 1 (2%) Artery, Inflammation 1 (2%) Artery, Inflammation, Chronic Active 1 (2%) Artery, Thrombosis 1 (2%) Lymphoid Tissue, Hyperplasia 1 (2%) Intestine Small, Jejunum (53) (50) (52) (51) Hyperplasia, Lymphoid 2 (4%) Ulcer 1 (2%) Intestine Small, Ileum (53) (50) (52) (50) Hyperplasia, Lymphoid 1 (2%) Liver (53) (50) (52) (51) Angiectasis 3 (6%) 1 (2%) 2 (4%) 3 (6%) Basophilic Focus 9 (17%) 4 (8%) 2 (4%) 8 (16%) Basophilic Focus, Multiple 13 (25%) 1 (2%) 1 (2%) 10 (20%) Cholangiofibrosis 5 (10%) 7 (13%) 13 (25%) Clear Cell Focus 3 (6%) 1 (2%) 3 (6%) 5 (10%) Clear Cell Focus, Multiple 6 (11%) 4 (8%) 6 (12%) Eosinophilic Focus 7 (13%) 6 (12%) 7 (13%) Eosinophilic Focus, Multiple 7 (13%) 21 (42%) 33 (63%) 45 (88%) a Number of animals examined microscopically at site and number of animals with lesion Page 2 NTP Experiment-Test: 96020-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC TEF EVALUATION (BINARY MIXTURE; PCB 126/PCB 153) Date: 03/03/04 Route: GAVAGE Time: 09:44:17 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 0 NG / 300 NG / 300 NG / 300 NG / 0 UG 100 UG 300 UG 3000 UG ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Fatty Change, Diffuse 3 (6%) 28 (56%) 31 (60%) 47 (92%) Fatty Change, Focal 3 (6%) 4 (8%) 1 (2%) 11 (22%) Hematopoietic Cell Proliferation 27 (51%) 18 (36%) 19 (37%) 29 (57%) Hemorrhage 1 (2%) Hyperplasia, Nodular 20 (40%) 24 (46%) 21 (41%) Inflammation 44 (83%) 47 (94%) 48 (92%) 46 (90%) Mixed Cell Focus 7 (13%) 2 (4%) 1 (2%) Mixed Cell Focus, Multiple 19 (36%) 27 (54%) 24 (46%) 26 (51%) Necrosis 4 (8%) 6 (12%) 4 (8%) 7 (14%) Pigmentation 2 (4%) 50 (100%) 50 (96%) 44 (86%) Toxic Hepatopathy 44 (88%) 48 (92%) 48 (94%) Bile Duct, Cyst 4 (8%) 4 (8%) 5 (10%) 6 (12%) Bile Duct, Fibrosis 1 (2%) 4 (8%) 5 (10%) Bile Duct, Hyperplasia 8 (15%) 20 (40%) 29 (56%) 40 (78%) Centrilobular, Degeneration 5 (9%) 6 (12%) 4 (8%) 2 (4%) Centrilobular, Fibrosis 1 (2%) 1 (2%) Hepatocyte, Hypertrophy 1 (2%) 22 (44%) 33 (63%) 47 (92%) Hepatocyte, Multinucleated 42 (84%) 46 (88%) 44 (86%) Oval Cell, Hyperplasia 2 (4%) 33 (66%) 39 (75%) 43 (84%) Portal, Fibrosis 3 (6%) 7 (13%) 10 (20%) Serosa, Inflammation, Chronic Active 1 (2%) Mesentery (47) (31) (47) (47) Artery, Inflammation, Chronic Active 1 (2%) 1 (3%) 2 (4%) 1 (2%) Fat, Necrosis 1 (2%) Oral Mucosa (12) (28) (30) (41) Gingival, Hyperplasia, Squamous 8 (67%) 21 (75%) 22 (73%) 29 (71%) Pancreas (53) (49) (52) (49) Inflammation, Chronic Active 5 (10%) 1 (2%) 5 (10%) Necrosis 1 (2%) Acinus, Atrophy 4 (8%) 1 (2%) 5 (10%) Acinus, Hyperplasia 2 (4%) 1 (2%) 1 (2%) Acinus, Vacuolization Cytoplasmic 3 (6%) 7 (13%) 44 (90%) Artery, Inflammation, Chronic Active 4 (8%) 2 (4%) 3 (6%) Stomach, Forestomach (53) (50) (52) (51) Cyst 1 (2%) Hyperkeratosis 2 (4%) 2 (4%) Hyperplasia, Squamous 1 (2%) 6 (12%) 7 (13%) 9 (18%) Inflammation 1 (2%) 6 (12%) Mineralization 1 (2%) Ulcer 1 (2%) 2 (4%) 1 (2%) Artery, Inflammation, Chronic Active 2 (4%) Stomach, Glandular (53) (50) (52) (51) Ectopic Tissue 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 3 NTP Experiment-Test: 96020-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC TEF EVALUATION (BINARY MIXTURE; PCB 126/PCB 153) Date: 03/03/04 Route: GAVAGE Time: 09:44:17 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 0 NG / 300 NG / 300 NG / 300 NG / 0 UG 100 UG 300 UG 3000 UG ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Erosion 3 (6%) 1 (2%) Mineralization 4 (8%) 1 (2%) 1 (2%) Tooth (23) (25) (35) (42) Peridontal Tissue, Inflammation 23 (100%) 25 (100%) 35 (100%) 42 (100%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Blood Vessel (53) (50) (53) (51) Aorta, Mineralization 1 (2%) Heart (53) (50) (53) (50) Cardiomyopathy 22 (42%) 18 (36%) 26 (49%) 25 (50%) Inflammation, Chronic Active 1 (2%) Mineralization 1 (2%) Thrombosis 1 (2%) Coronary Artery, Inflammation, Chronic Active 1 (2%) Endocardium, Hyperplasia 1 (2%) Pericardium, Necrosis 1 (2%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (53) (49) (52) (51) Angiectasis 17 (32%) 28 (57%) 23 (44%) 7 (14%) Atrophy 2 (4%) 3 (6%) 5 (10%) Degeneration, Cystic 13 (25%) 14 (29%) 14 (27%) 18 (35%) Hematopoietic Cell Proliferation 1 (2%) Hyperplasia 11 (21%) 17 (35%) 25 (48%) 21 (41%) Hypertrophy 47 (89%) 42 (86%) 41 (79%) 40 (78%) Necrosis 1 (2%) 3 (6%) 2 (4%) Vacuolization Cytoplasmic 11 (21%) 15 (31%) 10 (19%) 13 (25%) Adrenal Medulla (52) (49) (52) (49) Hyperplasia 15 (29%) 8 (16%) 13 (25%) 6 (12%) Islets, Pancreatic (53) (49) (52) (49) Hyperplasia 1 (2%) Pituitary Gland (53) (50) (52) (51) Angiectasis 17 (32%) 14 (28%) 17 (33%) 7 (14%) Cyst 1 (2%) Cytoplasmic Alteration 1 (2%) 2 (4%) Inflammation 1 (2%) Necrosis 1 (2%) Vacuolization Cytoplasmic 1 (2%) 2 (4%) Pars Distalis, Hyperplasia 13 (25%) 17 (34%) 20 (38%) 21 (41%) a Number of animals examined microscopically at site and number of animals with lesion Page 4 NTP Experiment-Test: 96020-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC TEF EVALUATION (BINARY MIXTURE; PCB 126/PCB 153) Date: 03/03/04 Route: GAVAGE Time: 09:44:17 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 0 NG / 300 NG / 300 NG / 300 NG / 0 UG 100 UG 300 UG 3000 UG ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM - CONT Thyroid Gland (53) (49) (52) (50) Fibrosis 1 (2%) Inflammation, Chronic 1 (2%) C-Cell, Hyperplasia 15 (28%) 16 (33%) 12 (23%) 17 (34%) Follicle, Cyst 2 (4%) Follicular Cell, Hyperplasia 1 (2%) Follicular Cell, Hypertrophy 14 (26%) 28 (57%) 35 (67%) 44 (88%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Clitoral Gland (53) (49) (53) (50) Hyperplasia, Squamous 1 (2%) Inflammation 45 (85%) 38 (78%) 40 (75%) 40 (80%) Duct, Cyst 38 (72%) 41 (84%) 43 (81%) 41 (82%) Ovary (53) (48) (52) (50) Atrophy 45 (85%) 46 (96%) 43 (83%) 36 (72%) Cyst 14 (26%) 16 (33%) 14 (27%) 19 (38%) Inflammation, Chronic Active 1 (2%) 4 (8%) Inflammation, Granulomatous 1 (2%) Inflammation, Suppurative 1 (2%) Oviduct (1) (1) (2) (3) Cyst 1 (100%) 2 (100%) Inflammation, Chronic Active 3 (100%) Metaplasia, Squamous 1 (100%) Uterus (53) (50) (52) (50) Adenomyosis 1 (2%) Hemorrhage 1 (2%) Inflammation, Chronic Active 3 (6%) 4 (8%) 7 (13%) 8 (16%) Inflammation, Suppurative 3 (6%) 2 (4%) 10 (19%) 8 (16%) Metaplasia, Squamous 27 (51%) 27 (54%) 36 (69%) 34 (68%) Cervix, Cyst 1 (2%) Endometrium, Hyperplasia, Cystic 28 (53%) 25 (50%) 18 (35%) 15 (30%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (53) (50) (53) (51) a Number of animals examined microscopically at site and number of animals with lesion Page 5 NTP Experiment-Test: 96020-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC TEF EVALUATION (BINARY MIXTURE; PCB 126/PCB 153) Date: 03/03/04 Route: GAVAGE Time: 09:44:17 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 0 NG / 300 NG / 300 NG / 300 NG / 0 UG 100 UG 300 UG 3000 UG ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - CONT Hyperplasia 39 (74%) 38 (76%) 48 (91%) 39 (76%) Lymph Node (4) (2) (7) (5) Angiectasis 1 (14%) Inguinal, Hyperplasia, Plasma Cell 1 (14%) Lumbar, Ectasia 4 (100%) 1 (14%) 1 (20%) Lumbar, Hemorrhage 1 (20%) Lumbar, Hyperplasia, Plasma Cell 4 (100%) Mediastinal, Ectasia 2 (40%) Mediastinal, Hemorrhage 1 (14%) 2 (40%) Mediastinal, Hyperplasia, Histiocytic 1 (14%) 1 (20%) Mediastinal, Hyperplasia, Lymphoid 1 (50%) Mediastinal, Hyperplasia, Plasma Cell 1 (50%) 1 (20%) Pancreatic, Hyperplasia, Histiocytic 1 (14%) Pancreatic, Pigmentation 1 (14%) Renal, Ectasia 1 (14%) Renal, Hyperplasia, Histiocytic 1 (14%) Renal, Hyperplasia, Plasma Cell 1 (14%) Lymph Node, Mandibular (53) (49) (50) (49) Congestion 1 (2%) Ectasia 3 (6%) 2 (4%) Hyperplasia, Lymphoid 1 (2%) 2 (4%) 2 (4%) Hyperplasia, Plasma Cell 37 (70%) 33 (67%) 36 (72%) 32 (65%) Lymph Node, Mesenteric (53) (49) (52) (49) Hemorrhage 1 (2%) Hyperplasia, Histiocytic 1 (2%) Hyperplasia, Lymphoid 1 (2%) Hyperplasia, Plasma Cell 1 (2%) 2 (4%) Spleen (53) (49) (52) (49) Fibrosis 1 (2%) Hematopoietic Cell Proliferation 51 (96%) 41 (84%) 47 (90%) 45 (92%) Pigmentation 47 (89%) 48 (98%) 51 (98%) 49 (100%) Lymphoid Follicle, Atrophy 5 (10%) 4 (8%) 2 (4%) Red Pulp, Atrophy 1 (2%) 1 (2%) 1 (2%) Thymus (53) (48) (50) (47) Atrophy 33 (62%) 48 (100%) 42 (84%) 45 (96%) Cyst 1 (2%) Hemorrhage 1 (2%) 3 (6%) Hyperplasia, Lymphoid 2 (4%) Epithelial Cell, Hyperplasia 1 (2%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM a Number of animals examined microscopically at site and number of animals with lesion Page 6 NTP Experiment-Test: 96020-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC TEF EVALUATION (BINARY MIXTURE; PCB 126/PCB 153) Date: 03/03/04 Route: GAVAGE Time: 09:44:17 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 0 NG / 300 NG / 300 NG / 300 NG / 0 UG 100 UG 300 UG 3000 UG ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM - CONT Mammary Gland (53) (50) (53) (51) Cyst 3 (6%) 2 (4%) 3 (6%) 2 (4%) Hyperplasia 29 (55%) 14 (28%) 22 (42%) 15 (29%) Inflammation, Granulomatous 5 (9%) 2 (4%) 3 (6%) Duct, Cyst 1 (2%) Skin (53) (50) (53) (51) Angiectasis 1 (2%) Cyst Epithelial Inclusion 1 (2%) Edema 1 (2%) Fibrosis 1 (2%) Inflammation 2 (4%) Necrosis 1 (2%) Subcutaneous Tissue, Edema 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Skeletal Muscle (1) (1) (1) (3) Inflammation 1 (33%) Necrosis 1 (33%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (53) (50) (52) (51) Hemorrhage 1 (2%) 1 (2%) Hydrocephalus 1 (2%) 1 (2%) 1 (2%) Cerebellum, Hemorrhage 1 (2%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (53) (50) (53) (50) Hemorrhage 1 (2%) Infiltration Cellular, Histiocyte 47 (89%) 49 (98%) 46 (87%) 40 (80%) Inflammation 8 (15%) 2 (4%) 4 (8%) 2 (4%) Metaplasia, Squamous 3 (6%) 2 (4%) 6 (12%) Mineralization 1 (2%) Alveolar Epithelium, Hyperplasia 23 (43%) 5 (10%) 5 (9%) 8 (16%) Alveolar Epithelium, Metaplasia, Bronchiolar 39 (78%) 34 (64%) 30 (60%) Mediastinum, Necrosis 1 (2%) 1 (2%) Serosa, Inflammation 1 (2%) Nose (53) (50) (53) (51) a Number of animals examined microscopically at site and number of animals with lesion Page 7 NTP Experiment-Test: 96020-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC TEF EVALUATION (BINARY MIXTURE; PCB 126/PCB 153) Date: 03/03/04 Route: GAVAGE Time: 09:44:17 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 0 NG / 300 NG / 300 NG / 300 NG / 0 UG 100 UG 300 UG 3000 UG ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM - CONT Hyperplasia 1 (2%) Inflammation 22 (42%) 17 (34%) 13 (25%) 15 (29%) Nerve, Degeneration 1 (2%) Olfactory Epithelium, Degeneration 1 (2%) 1 (2%) Olfactory Epithelium, Dysplasia 1 (2%) Olfactory Epithelium, Metaplasia 4 (8%) 5 (10%) 6 (11%) 5 (10%) Respiratory Epithelium, Hyperplasia 10 (19%) 14 (28%) 11 (21%) 12 (24%) Respiratory Epithelium, Metaplasia 1 (2%) Trachea (53) (50) (53) (50) Inflammation 1 (2%) Peritracheal Tissue, Inflammation 1 (2%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (53) (50) (52) (51) Anterior Chamber, Ciliary Body, Cornea, Inflammation 2 (4%) 1 (2%) Cornea, Inflammation 1 (2%) 1 (2%) Retina, Atrophy 1 (2%) 2 (4%) 5 (10%) Harderian Gland (53) (49) (52) (51) Inflammation 20 (38%) 15 (31%) 14 (27%) 17 (33%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (53) (48) (52) (51) Accumulation, Hyaline Droplet 2 (4%) 1 (2%) 2 (4%) Calculus Micro Observation Only 7 (13%) 6 (13%) 4 (8%) 6 (12%) Casts Protein 2 (4%) Cyst 1 (2%) 1 (2%) Hydronephrosis 2 (4%) Infarct 2 (4%) Inflammation, Chronic Active 1 (2%) 1 (2%) 1 (2%) Inflammation, Suppurative 5 (9%) 6 (13%) 5 (10%) 3 (6%) Mineralization 42 (79%) 39 (81%) 42 (81%) 33 (65%) Nephropathy 29 (55%) 30 (63%) 34 (65%) 34 (67%) Pigmentation 2 (4%) 7 (13%) 17 (33%) Pelvis, Dilatation 1 (2%) 4 (8%) 2 (4%) Pelvis, Inflammation 3 (6%) 1 (2%) 3 (6%) 8 (16%) Renal Tubule, Degeneration 2 (4%) Renal Tubule, Hyperplasia 1 (2%) Transitional Epithelium, Hyperplasia 2 (4%) 6 (13%) 11 (21%) 9 (18%) a Number of animals examined microscopically at site and number of animals with lesion Page 8 NTP Experiment-Test: 96020-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC TEF EVALUATION (BINARY MIXTURE; PCB 126/PCB 153) Date: 03/03/04 Route: GAVAGE Time: 09:44:17 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 0 NG / 300 NG / 300 NG / 300 NG / 0 UG 100 UG 300 UG 3000 UG ____________________________________________________________________________________________________________________________________ URINARY SYSTEM - CONT Ureter (1) (1) (1) Inflammation 1 (100%) 1 (100%) 1 (100%) Transitional Epithelium, Hyperplasia 1 (100%) 1 (100%) Urinary Bladder (53) (49) (52) (50) Inflammation 7 (13%) 3 (6%) 7 (13%) 8 (16%) Transitional Epithelium, Hyperplasia 1 (2%) 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 9 ------------------------------------------------------------ ---------- END OF REPORT ---------- ------------------------------------------------------------