TDMS Study 96007-01 Pathology Tables
NTP Experiment-Test: 96007-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION (PCB-126) Date: 10/01/03 Route: GAVAGE Time: 11:41:44 FINAL #3/RATS Facility: Battelle Columbus Laboratory Chemical CAS #: 57465-28-8 Lock Date: 01/09/01 Cage Range: All Reasons For Removal: 25022 Accidently Killed 25018 Dosing Accident 25019 Moribund Sacrifice 25020 Natural Death 25021 Terminal Sacrifice Removal Date Range: All Treatment Groups: Include 001 0 NG/KG Include 003 30 NG/KG Include 004 100 NG/KG Include 005 175 NG/KG Include 006 300 NG/KG Include 007 550 NG/KG Include 008 1000 NG/KG Include 009 1000 NG/KG/STOP a Number of animals examined microscopically at site and number of animals with lesion Page 1 NTP Experiment-Test: 96007-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION (PCB-126) Date: 10/01/03 Route: GAVAGE Time: 11:41:44 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 0 NG/KG 30 NG/KG 100 175 300 550 NG/KG NG/KG NG/KG NG/KG ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 98 98 98 98 98 98 Early Deaths Moribund Sacrifice 25 18 21 19 27 18 Natural Death 10 9 6 11 9 12 Accidently Killed 1 3 Dosing Accident 2 1 1 Survivors Natural Death 1 1 Terminal Sacrifice 15 24 25 22 16 23 Animals Examined Microscopically 53 55 53 53 53 53 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Esophagus (52) (55) (53) (53) (53) (52) Hemorrhage 1 (2%) Hyperplasia, Focal, Squamous 1 (2%) Muscularis, Degeneration 1 (2%) Muscularis, Inflammation 2 (4%) 1 (2%) 1 (2%) 1 (2%) 2 (4%) Periesophageal Tissue, Inflammation, Suppurative 1 (2%) Intestine Large, Colon (52) (55) (53) (53) (53) (51) Hyperplasia, Adenomatous 1 (2%) Inflammation 1 (2%) Parasite Metazoan 1 (2%) 2 (4%) 1 (2%) Intestine Large, Rectum (52) (55) (53) (52) (53) (52) Infiltration Cellular, Lymphocyte 1 (2%) Inflammation, Chronic Active 1 (2%) Mineralization 1 (2%) Parasite Metazoan 2 (4%) 2 (4%) 3 (6%) 1 (2%) Artery, Inflammation, Chronic Active 1 (2%) Intestine Large, Cecum (52) (54) (53) (51) (53) (52) Edema 1 (2%) Hyperplasia, Lymphoid 1 (2%) Inflammation 1 (2%) Intestine Small, Duodenum (52) (55) (52) (53) (53) (51) Erosion 1 (2%) Intestine Small, Ileum (52) (54) (52) (51) (53) (52) Hyperplasia, Lymphoid 1 (2%) Mineralization 1 (2%) Epithelium, Hyperplasia 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 2 NTP Experiment-Test: 96007-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION (PCB-126) Date: 10/01/03 Route: GAVAGE Time: 11:41:44 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 0 NG/KG 30 NG/KG 100 175 300 550 NG/KG NG/KG NG/KG NG/KG ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Serosa, Inflammation, Chronic Active 1 (2%) Liver (53) (55) (53) (53) (53) (51) Angiectasis 3 (6%) 8 (15%) 4 (8%) 1 (2%) 1 (2%) 2 (4%) Basophilic Focus 2 (4%) 4 (7%) 6 (11%) 7 (13%) 2 (4%) 3 (6%) Basophilic Focus, Multiple 5 (9%) 6 (11%) 4 (8%) 6 (11%) 2 (4%) 2 (4%) Cholangiofibrosis 1 (2%) 1 (2%) 1 (2%) 3 (6%) 13 (25%) Clear Cell Focus 1 (2%) 1 (2%) Clear Cell Focus, Multiple 1 (2%) Cytoplasmic Alteration 1 (2%) 1 (2%) 1 (2%) 1 (2%) Degeneration, Cystic 1 (2%) 1 (2%) Eosinophilic Focus 6 (11%) 4 (7%) 7 (13%) 4 (8%) 2 (4%) 3 (6%) Eosinophilic Focus, Multiple 5 (9%) 6 (11%) 6 (11%) 17 (32%) 15 (28%) 21 (41%) Fatty Change, Diffuse 5 (9%) 7 (13%) 14 (26%) 22 (42%) 30 (57%) 45 (88%) Fatty Change, Focal 2 (4%) 6 (11%) 8 (15%) 6 (11%) 3 (6%) 2 (4%) Hematopoietic Cell Proliferation 1 (2%) Hepatocyte, Multinucleate 2 (4%) 10 (19%) 14 (26%) 19 (36%) 46 (90%) Hepatodiaphragmatic Nodule 1 (2%) 1 (2%) 1 (2%) Hyperplasia, Nodular 1 (2%) 3 (6%) 26 (51%) Inflammation 36 (68%) 40 (73%) 49 (92%) 50 (94%) 51 (96%) 51 (100%) Mixed Cell Focus 4 (8%) 6 (11%) 7 (13%) 3 (6%) 3 (6%) Mixed Cell Focus, Multiple 17 (32%) 18 (33%) 25 (47%) 29 (55%) 30 (57%) 26 (51%) Necrosis 4 (8%) 2 (4%) 5 (9%) 8 (15%) 11 (21%) 15 (29%) Pigmentation 1 (2%) 11 (20%) 41 (77%) 39 (74%) 48 (91%) 51 (100%) Toxic Hepatopathy 6 (11%) 22 (42%) 27 (51%) 39 (74%) 51 (100%) Vacuolization Cytoplasmic 1 (2%) Artery, Inflammation, Chronic Active 1 (2%) 1 (2%) 1 (2%) Bile Duct, Cyst 3 (6%) 6 (11%) 2 (4%) 3 (6%) 8 (16%) Bile Duct, Fibrosis 4 (8%) 4 (7%) 3 (6%) 2 (4%) 1 (2%) 4 (8%) Bile Duct, Hyperplasia 3 (6%) 7 (13%) 7 (13%) 13 (25%) 14 (26%) 45 (88%) Hepatocyte, Degeneration 3 (6%) 1 (2%) 1 (2%) 1 (2%) 1 (2%) Hepatocyte, Hypertrophy 23 (42%) 32 (60%) 36 (68%) 42 (79%) 50 (98%) Oval Cell, Hyperplasia 1 (2%) 6 (11%) 7 (13%) 10 (19%) 38 (75%) Portal, Fibrosis 2 (4%) 1 (2%) Serosa, Inflammation 1 (2%) Mesentery (1) (4) (2) (7) (13) Inflammation, Chronic Active 1 (100%) Artery, Inflammation, Chronic Active 2 (50%) 2 (100%) 6 (86%) 10 (77%) Fat, Necrosis 1 (25%) 1 (14%) 1 (8%) Oral Mucosa (1) (1) (3) (4) (2) (6) Gingival, Hyperplasia, Squamous 1 (100%) 2 (67%) 2 (50%) 4 (67%) Pancreas (51) (55) (53) (53) (53) (52) Basophilic Focus 1 (2%) 1 (2%) Cyst 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 3 NTP Experiment-Test: 96007-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION (PCB-126) Date: 10/01/03 Route: GAVAGE Time: 11:41:44 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 0 NG/KG 30 NG/KG 100 175 300 550 NG/KG NG/KG NG/KG NG/KG ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Inflammation, Chronic Active 5 (10%) 1 (2%) 3 (6%) 4 (8%) 4 (8%) 6 (12%) Acinus, Atrophy 5 (10%) 3 (5%) 2 (4%) 7 (13%) 2 (4%) 11 (21%) Acinus, Hyperplasia 1 (2%) 1 (2%) 1 (2%) 1 (2%) Acinus, Vacuolization Cytoplasmic 1 (2%) 4 (8%) 9 (17%) 20 (38%) Artery, Inflammation, Chronic Active 4 (7%) 2 (4%) 4 (8%) 8 (15%) 15 (29%) Artery, Mineralization 1 (2%) 1 (2%) Duct, Hyperplasia 1 (2%) Duct, Inflammation, Chronic Active 2 (4%) Salivary Glands (51) (54) (53) (51) (52) (51) Atrophy 1 (2%) 1 (2%) Cyst 1 (2%) 1 (2%) Inflammation, Acute 1 (2%) Inflammation, Chronic Active 1 (2%) 1 (2%) Stomach, Forestomach (52) (55) (53) (53) (53) (51) Edema 1 (2%) 1 (2%) 1 (2%) Erosion 1 (2%) Hyperkeratosis 3 (5%) 1 (2%) 1 (2%) 3 (6%) 1 (2%) Hyperplasia, Squamous 3 (6%) 4 (7%) 6 (11%) 2 (4%) 5 (9%) 6 (12%) Inflammation, Acute 1 (2%) Inflammation, Chronic Active 1 (2%) 2 (4%) 1 (2%) 1 (2%) Mineralization 1 (2%) 1 (2%) 1 (2%) 1 (2%) Necrosis, Focal 1 (2%) Ulcer 3 (6%) 1 (2%) 1 (2%) 3 (6%) 2 (4%) Stomach, Glandular (51) (53) (53) (53) (53) (51) Erosion 1 (2%) 1 (2%) 1 (2%) Metaplasia, Focal 1 (2%) Mineralization 1 (2%) 1 (2%) 1 (2%) Tooth (12) (12) (10) (9) (10) (9) Peridontal Tissue, Inflammation, Chronic Active 2 (17%) 1 (11%) Peridontal Tissue, Inflammation, Suppurative 10 (83%) 12 (100%) 10 (100%) 9 (100%) 10 (100%) 8 (89%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Blood Vessel (53) (55) (53) (53) (53) (53) Aorta, Mineralization 3 (6%) 1 (2%) 1 (2%) 2 (4%) Heart (52) (54) (53) (53) (53) (51) Cardiomyopathy 9 (17%) 16 (30%) 17 (32%) 16 (30%) 24 (45%) 28 (55%) Degeneration 1 (2%) 1 (2%) 1 (2%) Inflammation 1 (2%) Mineralization 1 (2%) 1 (2%) 1 (2%) Thrombosis 1 (2%) 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 4 NTP Experiment-Test: 96007-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION (PCB-126) Date: 10/01/03 Route: GAVAGE Time: 11:41:44 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 0 NG/KG 30 NG/KG 100 175 300 550 NG/KG NG/KG NG/KG NG/KG ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM - CONT Artery, Inflammation, Chronic Active 1 (2%) Epicardium, Inflammation, Chronic Active 1 (2%) Epicardium, Inflammation, Suppurative 2 (4%) 1 (2%) Myocardium, Inflammation 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (52) (55) (53) (53) (53) (52) Angiectasis 11 (21%) 13 (24%) 25 (47%) 19 (36%) 20 (38%) 8 (15%) Atrophy 1 (2%) 3 (5%) 5 (9%) 3 (6%) 5 (9%) 19 (37%) Degeneration, Cystic 11 (21%) 14 (25%) 10 (19%) 14 (26%) 14 (26%) 16 (31%) Hyperplasia 23 (44%) 21 (38%) 27 (51%) 25 (47%) 25 (47%) 31 (60%) Hypertrophy 34 (65%) 41 (75%) 40 (75%) 41 (77%) 40 (75%) 41 (79%) Inflammation, Suppurative 1 (2%) Mineralization 1 (2%) 1 (2%) Necrosis 1 (2%) 1 (2%) 1 (2%) 1 (2%) 1 (2%) Thrombosis 1 (2%) Vacuolization Cytoplasmic 5 (10%) 3 (5%) 5 (9%) 2 (4%) 9 (17%) 4 (8%) Adrenal Medulla (52) (55) (53) (53) (53) (52) Angiectasis 2 (4%) 1 (2%) 2 (4%) 2 (4%) Hyperplasia 8 (15%) 18 (33%) 11 (21%) 11 (21%) 12 (23%) 6 (12%) Necrosis 1 (2%) Islets, Pancreatic (52) (54) (53) (53) (53) (52) Hyperplasia 1 (2%) 2 (4%) 1 (2%) 1 (2%) 1 (2%) Parathyroid Gland (47) (50) (48) (46) (49) (47) Hyperplasia 1 (2%) 1 (2%) 2 (4%) 1 (2%) 1 (2%) Pituitary Gland (51) (54) (53) (53) (53) (53) Angiectasis 14 (27%) 15 (28%) 22 (42%) 12 (23%) 16 (30%) 19 (36%) Cyst 3 (6%) 1 (2%) 1 (2%) 2 (4%) Cytoplasmic Alteration 1 (2%) 1 (2%) 1 (2%) 3 (6%) 1 (2%) Inflammation, Focal, Granulomatous 1 (2%) Necrosis 1 (2%) Pigmentation 1 (2%) Vacuolization Cytoplasmic 1 (2%) 1 (2%) Pars Distalis, Hyperplasia 18 (35%) 20 (37%) 23 (43%) 17 (32%) 21 (40%) 26 (49%) Thyroid Gland (52) (55) (52) (51) (52) (50) Angiectasis 1 (2%) 4 (8%) Cyst 1 (2%) 1 (2%) C-Cell, Hyperplasia 12 (23%) 21 (38%) 17 (33%) 19 (37%) 18 (35%) 16 (32%) Follicle, Cyst 1 (2%) Follicular Cell, Hyperplasia 1 (2%) 1 (2%) Follicular Cell, Hypertrophy 9 (17%) 13 (24%) 13 (25%) 17 (33%) 28 (54%) 26 (52%) a Number of animals examined microscopically at site and number of animals with lesion Page 5 NTP Experiment-Test: 96007-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION (PCB-126) Date: 10/01/03 Route: GAVAGE Time: 11:41:44 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 0 NG/KG 30 NG/KG 100 175 300 550 NG/KG NG/KG NG/KG NG/KG ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Clitoral Gland (50) (55) (52) (50) (53) (52) Hyperplasia 1 (2%) Hyperplasia, Squamous 1 (2%) Inflammation 28 (56%) 36 (65%) 39 (75%) 28 (56%) 30 (57%) 27 (52%) Duct, Cyst 29 (58%) 32 (58%) 34 (65%) 37 (74%) 39 (74%) 42 (81%) Ovary (52) (54) (53) (52) (52) (52) Atrophy 45 (87%) 49 (91%) 46 (87%) 45 (87%) 47 (90%) 46 (88%) Cyst 12 (23%) 17 (31%) 17 (32%) 15 (29%) 16 (31%) 18 (35%) Inflammation, Chronic Active 1 (2%) 1 (2%) Inflammation, Suppurative 1 (2%) 2 (4%) Necrosis 1 (2%) Artery, Inflammation, Chronic Active 1 (2%) 1 (2%) Oviduct (1) (1) (1) (3) Cyst 1 (33%) Inflammation, Chronic Active 1 (100%) Inflammation, Suppurative 1 (100%) 1 (100%) 2 (67%) Uterus (52) (55) (53) (52) (53) (52) Adenomyosis 1 (2%) 1 (2%) 2 (4%) Cyst 1 (2%) Erosion 1 (2%) Hemorrhage 1 (2%) 2 (4%) 1 (2%) Inflammation, Chronic Active 2 (4%) 1 (2%) 1 (2%) Inflammation, Granulomatous 1 (2%) Inflammation, Suppurative 12 (23%) 12 (22%) 11 (21%) 16 (31%) 10 (19%) 6 (12%) Metaplasia, Squamous 26 (50%) 33 (60%) 25 (47%) 28 (54%) 29 (55%) 27 (52%) Thrombosis 1 (2%) 1 (2%) Ulcer 1 (2%) Vacuolization Cytoplasmic 2 (4%) Artery, Inflammation, Chronic Active 1 (2%) 1 (2%) Cervix, Cyst 1 (2%) Cervix, Hyperplasia, Stromal 1 (2%) Endometrium, Hyperplasia, Cystic 23 (44%) 33 (60%) 28 (53%) 24 (46%) 26 (49%) 32 (62%) Epithelium, Hyperplasia 1 (2%) 1 (2%) Epithelium, Necrosis 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 6 NTP Experiment-Test: 96007-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION (PCB-126) Date: 10/01/03 Route: GAVAGE Time: 11:41:44 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 0 NG/KG 30 NG/KG 100 175 300 550 NG/KG NG/KG NG/KG NG/KG ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (53) (55) (53) (53) (53) (53) Angiectasis 1 (2%) Fibrosis 1 (2%) Hyperplasia 47 (89%) 37 (67%) 35 (66%) 44 (83%) 45 (85%) 46 (87%) Lymph Node (2) (6) (6) (6) (4) (7) Ectasia 1 (17%) Deep Cervical, Ectasia 1 (17%) Inguinal, Hyperplasia, Plasma Cell 1 (17%) Inguinal, Pigmentation 1 (17%) Lumbar, Ectasia 2 (29%) Lumbar, Hyperplasia 1 (14%) Lumbar, Hyperplasia, Lymphoid 1 (17%) Lumbar, Hyperplasia, Plasma Cell 2 (33%) 1 (25%) Mediastinal, Ectasia 2 (33%) 3 (50%) Mediastinal, Hemorrhage 2 (33%) 1 (17%) 1 (25%) Mediastinal, Hyperplasia, Lymphoid 1 (25%) Mediastinal, Hyperplasia, Plasma Cell 1 (25%) 1 (14%) Mediastinal, Inflammation, Suppurative 1 (25%) Pancreatic, Hyperplasia, Plasma Cell 1 (14%) Lymph Node, Mandibular (52) (53) (51) (51) (52) (51) Ectasia 1 (2%) 1 (2%) 4 (8%) 4 (8%) 4 (8%) 4 (8%) Hemorrhage 1 (2%) Hyperplasia, Lymphoid 1 (2%) 1 (2%) 1 (2%) 2 (4%) Hyperplasia, Plasma Cell 18 (35%) 24 (45%) 31 (61%) 21 (41%) 29 (56%) 11 (22%) Lymph Node, Mesenteric (52) (54) (52) (52) (53) (51) Atrophy 1 (2%) Ectasia 1 (2%) 1 (2%) Hemorrhage 2 (4%) 3 (6%) 1 (2%) 1 (2%) Hyperplasia, Histiocytic 3 (6%) 1 (2%) Hyperplasia, Plasma Cell 1 (2%) Pigmentation 1 (2%) Spleen (52) (55) (52) (53) (53) (52) Hematopoietic Cell Proliferation 39 (75%) 43 (78%) 46 (88%) 45 (85%) 41 (77%) 42 (81%) Hyperplasia, Lymphoid 1 (2%) 1 (2%) 1 (2%) Necrosis 1 (2%) Pigmentation 49 (94%) 50 (91%) 51 (98%) 51 (96%) 52 (98%) 52 (100%) Lymphoid Follicle, Atrophy 5 (9%) 3 (6%) 2 (4%) 5 (9%) 3 (6%) Red Pulp, Atrophy 4 (8%) 1 (2%) 1 (2%) Thymus (50) (52) (46) (48) (41) (49) Atrophy 37 (74%) 34 (65%) 41 (89%) 45 (94%) 36 (88%) 47 (96%) Fibrosis 1 (2%) Hemorrhage 1 (2%) 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 7 NTP Experiment-Test: 96007-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION (PCB-126) Date: 10/01/03 Route: GAVAGE Time: 11:41:44 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 0 NG/KG 30 NG/KG 100 175 300 550 NG/KG NG/KG NG/KG NG/KG ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - CONT Inflammation 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (52) (55) (53) (53) (53) (52) Cyst 8 (15%) 3 (5%) 1 (2%) 4 (8%) 5 (9%) 1 (2%) Fibrosis, Focal 1 (2%) Hyperplasia 32 (62%) 33 (60%) 30 (57%) 29 (55%) 21 (40%) 23 (44%) Inflammation, Chronic Active 1 (2%) 2 (4%) 2 (4%) Inflammation, Granulomatous 2 (4%) 2 (4%) 1 (2%) Skin (52) (55) (53) (53) (53) (53) Cyst, Squamous 1 (2%) 1 (2%) Ulcer 1 (2%) Dermis, Inflammation, Focal 1 (2%) Subcutaneous Tissue, Inflammation, Suppurative 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (53) (55) (53) (53) (53) (53) Inflammation, Chronic Active 1 (2%) Osteopetrosis 1 (2%) 2 (4%) Cartilage, Hypertrophy, Focal 1 (2%) Skeletal Muscle (1) (1) (1) Inflammation, Chronic Active 1 (100%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (53) (55) (53) (53) (53) (53) Hemorrhage 1 (2%) Hydrocephalus 1 (2%) 2 (4%) 1 (2%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (53) (55) (53) (53) (53) (51) Congestion 1 (2%) 1 (2%) 1 (2%) Infiltration Cellular, Histiocyte 41 (77%) 49 (89%) 45 (85%) 48 (91%) 45 (85%) 49 (96%) Inflammation, Chronic Active 5 (9%) 3 (5%) 1 (2%) 1 (2%) Inflammation, Granulomatous 3 (6%) 2 (4%) a Number of animals examined microscopically at site and number of animals with lesion Page 8 NTP Experiment-Test: 96007-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION (PCB-126) Date: 10/01/03 Route: GAVAGE Time: 11:41:44 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 0 NG/KG 30 NG/KG 100 175 300 550 NG/KG NG/KG NG/KG NG/KG ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM - CONT Inflammation, Suppurative 1 (2%) Metaplasia, Squamous 1 (2%) 1 (2%) 2 (4%) 3 (6%) 9 (18%) Mineralization 1 (2%) 1 (2%) 1 (2%) Thrombosis 2 (4%) 1 (2%) Alveolar Epithelium, Hyperplasia 12 (23%) 1 (2%) 1 (2%) 2 (4%) Alveolar Epithelium, Metaplasia, Bronchiolar 29 (53%) 34 (64%) 41 (77%) 39 (74%) 47 (92%) Serosa, Fibrosis 2 (4%) Serosa, Inflammation, Chronic Active 1 (2%) Serosa, Inflammation, Suppurative 2 (4%) 1 (2%) 1 (2%) Vein, Thrombosis 1 (2%) Nose (53) (54) (52) (53) (52) (53) Nasolacrimal Duct, Inflammation 1 (2%) 1 (2%) 1 (2%) Nasolacrimal Duct, Glands, Hyperplasia 1 (2%) Nasolacrimal Duct, Respiratory Epithelium, Hyperplasia 1 (2%) Nasopharyngeal Duct, Inflammation, Suppurative 1 (2%) 1 (2%) Olfactory Epithelium, Inflammation, Suppurative 1 (2%) 1 (2%) Respiratory Epithelium, Hyperplasia 2 (4%) 1 (2%) 1 (2%) 2 (4%) 2 (4%) Respiratory Epithelium, Inflammation, Suppurative 1 (2%) 1 (2%) 1 (2%) Respiratory Epithelium, Metaplasia 1 (2%) 1 (2%) Turbinate, Cyst 1 (2%) Turbinate, Inflammation, Suppurative 2 (4%) 1 (2%) 1 (2%) 2 (4%) Trachea (53) (55) (53) (53) (53) (52) Inflammation 1 (2%) Peritracheal Tissue, Inflammation 1 (2%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Ear (1) Inflammation 1 (100%) Eye (51) (55) (53) (53) (53) (52) Atrophy 1 (2%) 1 (2%) Cataract 1 (2%) 1 (2%) Edema 1 (2%) Anterior Chamber, Inflammation, Suppurative 1 (2%) Anterior Chamber, Ciliary Body, Cornea, Inflammation, Suppurative 1 (2%) Cornea, Inflammation, Suppurative 1 (2%) Retina, Atrophy 3 (6%) 1 (2%) 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 9 NTP Experiment-Test: 96007-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION (PCB-126) Date: 10/01/03 Route: GAVAGE Time: 11:41:44 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 0 NG/KG 30 NG/KG 100 175 300 550 NG/KG NG/KG NG/KG NG/KG ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM - CONT Retina, Degeneration 1 (2%) Harderian Gland (53) (53) (53) (53) (53) (52) Inflammation 2 (4%) 3 (6%) 6 (11%) 6 (11%) 3 (6%) 3 (6%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (53) (55) (53) (53) (53) (52) Calculus Micro Observation Only 1 (2%) 1 (2%) 1 (2%) Casts Protein 4 (8%) 3 (5%) 1 (2%) 6 (11%) Cyst 2 (4%) Inflammation, Chronic Active 2 (4%) 2 (4%) 1 (2%) 1 (2%) 1 (2%) 1 (2%) Inflammation, Suppurative 3 (6%) 1 (2%) Mineralization 32 (60%) 39 (71%) 44 (83%) 44 (83%) 44 (83%) 39 (75%) Necrosis 1 (2%) 1 (2%) 1 (2%) Nephropathy 32 (60%) 29 (53%) 38 (72%) 35 (66%) 38 (72%) 42 (81%) Papilla, Angiectasis 1 (2%) Pelvis, Dilatation 2 (4%) 1 (2%) 1 (2%) Pelvis, Inflammation, Chronic Active 2 (4%) 2 (4%) 2 (4%) Pelvis, Inflammation, Suppurative 2 (4%) 3 (6%) Renal Tubule, Accumulation, Hyaline Droplet 1 (2%) Renal Tubule, Dilatation 1 (2%) Transitional Epithelium, Hyperplasia 4 (8%) 2 (4%) 8 (15%) 4 (8%) 8 (15%) 8 (15%) Ureter (1) Mineralization 1 (100%) Transitional Epithelium, Hyperplasia 1 (100%) Urinary Bladder (51) (54) (53) (52) (52) (52) Edema 1 (2%) Hemorrhage 1 (2%) Inflammation 4 (8%) 6 (11%) 10 (19%) 6 (12%) 7 (13%) 4 (8%) Transitional Epithelium, Hyperplasia 1 (2%) 1 (2%) 1 (2%) 2 (4%) 1 (2%) 2 (4%) a Number of animals examined microscopically at site and number of animals with lesion Page 10 NTP Experiment-Test: 96007-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION (PCB-126) Date: 10/01/03 Route: GAVAGE Time: 11:41:44 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 1000 1000 NG/ NG/KG KG/STOP ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 98 50 Early Deaths Natural Death 12 6 Moribund Sacrifice 34 15 Dosing Accident 1 Survivors Terminal Sacrifice 7 28 Animals Examined Microscopically 53 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Esophagus (52) (50) Cyst 1 (2%) Muscularis, Inflammation 1 (2%) Intestine Large, Colon (53) (50) Parasite Metazoan 1 (2%) Intestine Large, Rectum (53) (50) Parasite Metazoan 1 (2%) 1 (2%) Intestine Small, Duodenum (53) (50) Erosion 2 (4%) Ulcer 1 (2%) Epithelium, Hyperplasia 1 (2%) Intestine Small, Jejunum (53) (50) Hyperplasia, Lymphoid 1 (2%) Liver (53) (50) Angiectasis 2 (4%) 8 (16%) Basophilic Focus 2 (4%) 7 (14%) Basophilic Focus, Multiple 3 (6%) 9 (18%) Cholangiofibrosis 22 (42%) 1 (2%) Clear Cell Focus 1 (2%) Clear Cell Focus, Multiple 4 (8%) Cytoplasmic Alteration 1 (2%) Degeneration, Cystic 2 (4%) 3 (6%) Eosinophilic Focus 6 (11%) 3 (6%) Eosinophilic Focus, Multiple 11 (21%) 9 (18%) Fatty Change, Diffuse 47 (89%) 12 (24%) Fatty Change, Focal 11 (22%) Hepatocyte, Multinucleate 49 (92%) 20 (40%) Hepatodiaphragmatic Nodule 1 (2%) 1 (2%) Hyperplasia, Nodular 39 (74%) a Number of animals examined microscopically at site and number of animals with lesion Page 11 NTP Experiment-Test: 96007-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION (PCB-126) Date: 10/01/03 Route: GAVAGE Time: 11:41:44 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 1000 1000 NG/ NG/KG KG/STOP ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Inflammation 51 (96%) 46 (92%) Mixed Cell Focus 4 (8%) 1 (2%) Mixed Cell Focus, Multiple 5 (9%) 35 (70%) Multinucleated 1 (2%) Necrosis 17 (32%) 4 (8%) Pigmentation 48 (91%) 48 (96%) Toxic Hepatopathy 49 (92%) 15 (30%) Bile Duct, Cyst 12 (23%) 5 (10%) Bile Duct, Fibrosis 5 (9%) 4 (8%) Bile Duct, Hyperplasia 45 (85%) 16 (32%) Bile Duct, Inflammation 1 (2%) Hepatocyte, Degeneration 7 (13%) Hepatocyte, Hypertrophy 49 (92%) 21 (42%) Oval Cell, Hyperplasia 40 (75%) 1 (2%) Portal, Fibrosis 10 (19%) Serosa, Inflammation 1 (2%) Mesentery (11) Inflammation, Chronic Active 3 (27%) Artery, Inflammation, Chronic Active 7 (64%) Fat, Necrosis 1 (9%) Oral Mucosa (11) (6) Gingival, Cyst, Squamous 1 (9%) Gingival, Hyperplasia, Squamous 3 (27%) 3 (50%) Pharyngeal, Hyperplasia, Squamous 1 (17%) Pancreas (51) (48) Basophilic Focus 1 (2%) Cyst 1 (2%) Inflammation, Chronic Active 13 (25%) 4 (8%) Necrosis 1 (2%) Acinus, Atrophy 18 (35%) 7 (15%) Acinus, Vacuolization Cytoplasmic 23 (45%) 1 (2%) Artery, Inflammation, Chronic Active 11 (22%) 1 (2%) Duct, Dilatation 2 (4%) Duct, Hyperplasia 1 (2%) Salivary Glands (51) (49) Atrophy 1 (2%) Cyst 2 (4%) Inflammation, Acute 1 (2%) Stomach, Forestomach (53) (50) Edema 2 (4%) Hyperkeratosis 2 (4%) Hyperplasia, Squamous 8 (15%) 2 (4%) Mineralization 2 (4%) a Number of animals examined microscopically at site and number of animals with lesion Page 12 NTP Experiment-Test: 96007-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION (PCB-126) Date: 10/01/03 Route: GAVAGE Time: 11:41:44 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 1000 1000 NG/ NG/KG KG/STOP ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Ulcer 2 (4%) Stomach, Glandular (53) (50) Erosion 1 (2%) Inflammation, Chronic Active 1 (2%) Mineralization 1 (2%) Artery, Inflammation, Chronic Active 1 (2%) Glands, Ectasia 1 (2%) Glands, Hyperplasia 1 (2%) Tooth (19) (12) Peridontal Tissue, Fibrosis 1 (5%) 1 (8%) Peridontal Tissue, Inflammation, Suppurative 18 (95%) 11 (92%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Blood Vessel (53) (50) Aorta, Mineralization 1 (2%) Heart (51) (50) Cardiomyopathy 32 (63%) 15 (30%) Mineralization 1 (2%) Thrombosis 1 (2%) 1 (2%) Artery, Inflammation, Chronic Active 1 (2%) Endocardium, Myocardium, Inflammation, Acute 1 (2%) Epicardium, Inflammation, Chronic Active 1 (2%) Epicardium, Inflammation, Suppurative 1 (2%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (53) (50) Angiectasis 1 (2%) 14 (28%) Atrophy 30 (57%) 9 (18%) Degeneration, Cystic 10 (19%) 20 (40%) Hyperplasia 24 (45%) 26 (52%) Hypertrophy 41 (77%) 42 (84%) Inflammation, Suppurative 1 (2%) Mineralization 1 (2%) Necrosis 2 (4%) 2 (4%) Vacuolization Cytoplasmic 17 (32%) 6 (12%) Adrenal Medulla (53) (50) Hyperplasia 1 (2%) 9 (18%) Parathyroid Gland (46) (44) Cyst 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 13 NTP Experiment-Test: 96007-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION (PCB-126) Date: 10/01/03 Route: GAVAGE Time: 11:41:44 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 1000 1000 NG/ NG/KG KG/STOP ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM - CONT Hyperplasia 2 (5%) Pituitary Gland (53) (48) Angiectasis 9 (17%) 14 (29%) Cyst 1 (2%) 1 (2%) Cytoplasmic Alteration 1 (2%) Pars Distalis, Hyperplasia 17 (32%) 17 (35%) Thyroid Gland (48) (47) Angiectasis 1 (2%) Atrophy 1 (2%) Infiltration Cellular, Lymphocyte 1 (2%) C-Cell, Hyperplasia 19 (40%) 18 (38%) Follicular Cell, Hyperplasia 1 (2%) Follicular Cell, Hypertrophy 16 (33%) 22 (47%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Clitoral Gland (51) (48) Inflammation 22 (43%) 32 (67%) Duct, Cyst 45 (88%) 39 (81%) Ovary (53) (50) Atrophy 33 (62%) 47 (94%) Cyst 11 (21%) 17 (34%) Oviduct (1) (2) Inflammation, Suppurative 1 (100%) 2 (100%) Uterus (53) (50) Hemorrhage 1 (2%) Inflammation, Chronic Active 1 (2%) Inflammation, Suppurative 4 (8%) 11 (22%) Metaplasia, Squamous 11 (21%) 28 (56%) Endometrium, Hyperplasia, Cystic 9 (17%) 31 (62%) Epithelium, Hyperplasia 1 (2%) Vagina (1) Cyst 1 (100%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM a Number of animals examined microscopically at site and number of animals with lesion Page 14 NTP Experiment-Test: 96007-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION (PCB-126) Date: 10/01/03 Route: GAVAGE Time: 11:41:44 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 1000 1000 NG/ NG/KG KG/STOP ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - CONT Bone Marrow (53) (50) Atrophy 1 (2%) Hyperplasia 46 (87%) 34 (68%) Lymph Node (12) (2) Iliac, Ectasia 1 (50%) Mediastinal, Angiectasis 1 (8%) Mediastinal, Ectasia 5 (42%) Mediastinal, Hemorrhage 6 (50%) Mediastinal, Hyperplasia, Lymphoid 1 (8%) Mediastinal, Pigmentation 2 (17%) Pancreatic, Hemorrhage 1 (8%) Lymph Node, Mandibular (51) (49) Atrophy 1 (2%) Ectasia 3 (6%) 3 (6%) Hemorrhage 1 (2%) Hyperplasia, Lymphoid 1 (2%) Hyperplasia, Plasma Cell 15 (29%) 21 (43%) Lymph Node, Mesenteric (53) (50) Atrophy 1 (2%) 2 (4%) Ectasia 1 (2%) Hemorrhage 2 (4%) Hyperplasia, Histiocytic 1 (2%) 1 (2%) Hyperplasia, Lymphoid 2 (4%) Hyperplasia, Plasma Cell 1 (2%) Spleen (52) (50) Hematopoietic Cell Proliferation 37 (71%) 37 (74%) Hyperplasia, Lymphoid 3 (6%) Pigmentation 50 (96%) 50 (100%) Lymphoid Follicle, Atrophy 6 (12%) 4 (8%) Red Pulp, Atrophy 2 (4%) Thymus (44) (43) Atrophy 41 (93%) 39 (91%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (53) (50) Cyst 1 (2%) 13 (26%) Hyperplasia 9 (17%) 22 (44%) Skin (53) (50) Cyst, Squamous 1 (2%) 2 (4%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 15 NTP Experiment-Test: 96007-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION (PCB-126) Date: 10/01/03 Route: GAVAGE Time: 11:41:44 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 1000 1000 NG/ NG/KG KG/STOP ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Skeletal Muscle (1) Inflammation, Chronic Active 1 (100%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (53) (50) Hemorrhage 1 (2%) Inflammation, Focal, Suppurative 1 (2%) Necrosis, Focal 1 (2%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (51) (50) Hemorrhage 1 (2%) 1 (2%) Infiltration Cellular, Histiocyte 42 (82%) 42 (84%) Inflammation, Chronic Active 2 (4%) Metaplasia, Squamous 4 (8%) Mineralization 1 (2%) 1 (2%) Alveolar Epithelium, Metaplasia, Bronchiolar 40 (78%) 32 (64%) Serosa, Inflammation, Suppurative 1 (2%) Nose (53) (50) Goblet Cell, Respiratory Epithelium, Hyperplasia 1 (2%) Nasolacrimal Duct, Inflammation 1 (2%) 1 (2%) Nasolacrimal Duct, Respiratory Epithelium, Hyperplasia 1 (2%) Nasopharyngeal Duct, Respiratory Epithelium, Hyperplasia 1 (2%) Respiratory Epithelium, Hyperplasia 1 (2%) 1 (2%) Turbinate, Cyst 1 (2%) Turbinate, Inflammation, Suppurative 4 (8%) 1 (2%) Vomeronasal Organ, Vacuolization Cytoplasmic 1 (2%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (52) (50) Anterior Chamber, Inflammation, Suppurative 1 (2%) 1 (2%) Cornea, Inflammation, Suppurative 2 (4%) 1 (2%) Optic Nerve, Degeneration 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 16 NTP Experiment-Test: 96007-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION (PCB-126) Date: 10/01/03 Route: GAVAGE Time: 11:41:44 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 1000 1000 NG/ NG/KG KG/STOP ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM - CONT Retina, Atrophy 4 (8%) Harderian Gland (52) (50) Inflammation 6 (12%) 9 (18%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (53) (50) Casts Protein 2 (4%) 3 (6%) Inflammation, Suppurative 2 (4%) Mineralization 37 (70%) 45 (90%) Necrosis 1 (2%) Nephropathy 47 (89%) 38 (76%) Papilla, Necrosis 1 (2%) Pelvis, Dilatation 2 (4%) 1 (2%) Pelvis, Hemorrhage 1 (2%) Pelvis, Inflammation, Chronic Active 1 (2%) 1 (2%) Pelvis, Metaplasia, Squamous 1 (2%) Transitional Epithelium, Hyperplasia 11 (21%) 2 (4%) Ureter (3) Inflammation 1 (33%) Metaplasia, Squamous 2 (67%) Mineralization 2 (67%) Transitional Epithelium, Hyperplasia 3 (100%) Urinary Bladder (53) (50) Inflammation 6 (11%) 3 (6%) Metaplasia, Squamous 1 (2%) Transitional Epithelium, Hyperplasia 2 (4%) a Number of animals examined microscopically at site and number of animals with lesion Page 17 ------------------------------------------------------------ ---------- END OF REPORT ---------- ------------------------------------------------------------