NTP Experiment-Test: 96022-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC TEF EVALUATION (PCB MIXTURE;PCB 126/PCB 118) Date: 11/15/04 Route: GAVAGE Time: 11:11:28 CORE + STOP STUDY FINAL #1; REVISION #1 RATS Facility: Battelle Columbus Laboratory Chemical CAS #: TEFPCBMIX Lock Date: 11/04/02 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: 96022-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC TEF EVALUATION (PCB MIXTURE;PCB 126/PCB 118) Date: 11/15/04 Route: GAVAGE Time: 11:11:28 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 98 86 98 86 98 86 Early Deaths Moribund Sacrifice 21 20 21 23 43 44 Natural Death 5 14 8 13 10 22 Dosing Accident 2 Survivors Terminal Sacrifice 27 17 24 15 Animals Examined Microscopically 53 51 53 53 53 66 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Esophagus (53) (51) (53) (53) (53) (66) Degeneration 1 (2%) Muscularis, Inflammation 3 (6%) 2 (4%) 3 (6%) 3 (6%) 2 (3%) Intestine Large, Colon (53) (51) (53) (53) (52) (65) Parasite Metazoan 2 (4%) 1 (2%) 2 (3%) Artery, Inflammation, Chronic Active 1 (2%) 1 (2%) Intestine Large, Rectum (52) (51) (53) (53) (52) (66) Hyperplasia, Cystic 1 (2%) Parasite Metazoan 3 (6%) 2 (4%) 2 (4%) 2 (4%) 1 (2%) Artery, Inflammation, Chronic Active 1 (2%) 1 (2%) 3 (6%) 1 (2%) Intestine Large, Cecum (53) (51) (53) (53) (52) (65) Edema 2 (3%) Inflammation 2 (3%) Artery, Inflammation, Chronic Active 2 (4%) Intestine Small, Duodenum (53) (51) (53) (53) (53) (65) Dilatation 1 (2%) Erosion 1 (2%) Hyperplasia 1 (2%) Artery, Inflammation, Chronic Active 1 (2%) Intestine Small, Ileum (53) (51) (53) (53) (52) (65) Parasite Metazoan 1 (2%) Liver (53) (51) (53) (53) (53) (65) Angiectasis 1 (2%) 2 (4%) 1 (2%) 3 (6%) 2 (3%) Basophilic Focus 14 (26%) 8 (16%) 6 (11%) 5 (9%) 4 (8%) Basophilic Focus, Multiple 13 (25%) 8 (16%) 4 (8%) 3 (6%) Cholangiofibrosis 1 (2%) 2 (4%) 3 (6%) 21 (40%) 42 (79%) 29 (45%) Clear Cell Focus 4 (8%) 1 (2%) Clear Cell Focus, Multiple 1 (2%) 1 (2%) Degeneration, Cystic 1 (2%) 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 2 NTP Experiment-Test: 96022-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC TEF EVALUATION (PCB MIXTURE;PCB 126/PCB 118) Date: 11/15/04 Route: GAVAGE Time: 11:11:28 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Eosinophilic Focus 5 (9%) 5 (10%) 11 (21%) 1 (2%) 2 (4%) Eosinophilic Focus, Multiple 5 (9%) 16 (31%) 12 (23%) 14 (26%) 4 (8%) 10 (15%) Fatty Change, Diffuse 3 (6%) 14 (27%) 27 (51%) 45 (85%) 49 (92%) 56 (86%) Fatty Change, Focal 10 (19%) 10 (20%) 6 (11%) 1 (2%) 10 (19%) 6 (9%) Hematopoietic Cell Proliferation 27 (51%) 27 (53%) 30 (57%) 32 (60%) 22 (42%) 11 (17%) Hepatodiaphragmatic Nodule 2 (4%) 2 (4%) 2 (4%) Hyperplasia, Nodular 10 (19%) 45 (85%) 50 (94%) 61 (94%) Inflammation 49 (92%) 47 (92%) 50 (94%) 52 (98%) 51 (96%) 64 (98%) Metaplasia 4 (8%) 4 (6%) Mineralization 1 (2%) Mixed Cell Focus 5 (9%) 5 (10%) 4 (8%) 1 (2%) 3 (5%) Mixed Cell Focus, Multiple 33 (62%) 23 (45%) 28 (53%) 16 (30%) 1 (2%) Necrosis 3 (6%) 13 (25%) 6 (11%) 26 (49%) 17 (32%) 27 (42%) Pigmentation 5 (9%) 18 (35%) 38 (72%) 52 (98%) 53 (100%) 60 (92%) Thrombosis 1 (2%) Toxic Hepatopathy 8 (16%) 32 (60%) 51 (96%) 52 (98%) 64 (98%) Artery, Inflammation 1 (2%) 1 (2%) Bile Duct, Cyst 4 (8%) 3 (6%) 3 (6%) 14 (26%) 25 (47%) 14 (22%) Bile Duct, Dilatation 1 (2%) Bile Duct, Fibrosis 6 (11%) 2 (4%) 3 (6%) 10 (19%) 3 (6%) 4 (6%) Bile Duct, Hyperplasia 5 (9%) 5 (10%) 7 (13%) 46 (87%) 52 (98%) 60 (92%) Centrilobular, Degeneration 2 (4%) 3 (6%) 8 (15%) 8 (15%) 3 (6%) 8 (12%) Centrilobular, Fibrosis 7 (13%) 36 (68%) 52 (98%) 57 (88%) Hepatocyte, Glandular Structures 1 (2%) 5 (9%) 25 (38%) Hepatocyte, Hypertrophy 16 (31%) 22 (42%) 47 (89%) 52 (98%) 65 (100%) Hepatocyte, Multinucleated 9 (18%) 21 (40%) 48 (91%) 52 (98%) 48 (74%) Oval Cell, Hyperplasia 4 (8%) 4 (8%) 23 (43%) 49 (92%) 52 (98%) 62 (95%) Portal, Fibrosis 2 (4%) 37 (70%) 52 (98%) 58 (89%) Serosa, Inflammation 2 (4%) Mesentery (53) (35) (45) (49) (52) (63) Inflammation 1 (3%) Necrosis 1 (2%) 1 (2%) Artery, Inflammation, Chronic Active 1 (3%) 1 (2%) 9 (18%) 9 (17%) 3 (5%) Fat, Necrosis 1 (2%) 3 (6%) 3 (5%) Oral Mucosa (53) (51) (53) (53) (53) (66) Cyst 1 (2%) Gingival, Hyperplasia, Squamous 11 (21%) 10 (20%) 20 (38%) 24 (45%) 27 (51%) 18 (27%) Pancreas (53) (51) (53) (53) (53) (65) Edema 1 (2%) 4 (8%) 19 (29%) Hemorrhage 2 (3%) Inflammation, Chronic Active 1 (2%) 5 (10%) 4 (8%) 3 (6%) 2 (4%) 6 (9%) Lipomatosis 1 (2%) 1 (2%) Acinus, Atrophy 1 (2%) 5 (10%) 3 (6%) 5 (9%) 9 (17%) 8 (12%) a Number of animals examined microscopically at site and number of animals with lesion Page 3 NTP Experiment-Test: 96022-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC TEF EVALUATION (PCB MIXTURE;PCB 126/PCB 118) Date: 11/15/04 Route: GAVAGE Time: 11:11:28 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Acinus, Hyperplasia 2 (4%) Acinus, Hyperplasia, Focal 1 (2%) Acinus, Vacuolization Cytoplasmic 1 (2%) 8 (15%) 39 (74%) 49 (92%) 43 (66%) Artery, Inflammation, Chronic Active 2 (4%) 2 (4%) 21 (40%) 14 (26%) 4 (6%) Duct, Dilatation 1 (2%) 3 (6%) Salivary Glands (53) (51) (53) (52) (52) (66) Atrophy 1 (2%) Stomach, Forestomach (53) (51) (53) (53) (53) (65) Edema 2 (4%) 1 (2%) Erosion 1 (2%) 1 (2%) Hemorrhage 1 (2%) Hyperplasia, Squamous 4 (8%) 1 (2%) 3 (6%) 11 (21%) 4 (8%) 9 (14%) Inflammation 2 (4%) 2 (4%) 4 (8%) 1 (2%) Mineralization 1 (2%) 2 (3%) Ulcer 2 (4%) 1 (2%) 1 (2%) 1 (2%) Artery, Inflammation, Chronic Active 2 (4%) Stomach, Glandular (53) (51) (53) (53) (53) (65) Cyst 1 (2%) Erosion 1 (2%) 1 (2%) 2 (3%) Hemorrhage 1 (2%) 3 (5%) Inflammation 1 (2%) Mineralization 12 (23%) 6 (12%) 6 (11%) 1 (2%) 6 (11%) 5 (8%) Glands, Cyst 1 (2%) Tongue (1) Cyst 1 (100%) Tooth (29) (26) (33) (34) (29) (25) Peridontal Tissue, Inflammation 29 (100%) 26 (100%) 33 (100%) 34 (100%) 29 (100%) 25 (100%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Blood Vessel (53) (51) (52) (53) (53) (66) Mineralization 1 (2%) Aorta, Adventitia, Hemorrhage 1 (2%) 1 (2%) Aorta, Adventitia, Inflammation 1 (2%) 2 (3%) Heart (53) (51) (53) (53) (53) (65) Cardiomyopathy 20 (38%) 13 (25%) 17 (32%) 34 (64%) 14 (26%) 19 (29%) Atrium, Thrombosis 1 (2%) Coronary Artery, Inflammation, Chronic Active 1 (2%) 1 (2%) 7 (13%) 10 (19%) 9 (14%) Coronary Artery, Thrombosis 1 (2%) Endocardium, Hyperplasia 1 (2%) Epicardium, Hemorrhage 1 (2%) Epicardium, Inflammation 1 (2%) 1 (2%) 6 (11%) 13 (25%) 6 (9%) a Number of animals examined microscopically at site and number of animals with lesion Page 4 NTP Experiment-Test: 96022-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC TEF EVALUATION (PCB MIXTURE;PCB 126/PCB 118) Date: 11/15/04 Route: GAVAGE Time: 11:11:28 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM - CONT Myocardium, Hemorrhage 3 (5%) Myocardium, Inflammation 1 (2%) Myocardium, Necrosis 2 (3%) Pericardium, Inflammation, Chronic Active 1 (2%) Valve, Fibrosis 1 (2%) Valve, Hyperplasia 1 (2%) Ventricle, Thrombosis 1 (2%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (53) (51) (53) (53) (53) (65) Angiectasis 42 (79%) 35 (69%) 39 (74%) 25 (47%) 4 (8%) 6 (9%) Atrophy 2 (4%) 1 (2%) 15 (28%) 44 (83%) 40 (62%) Degeneration, Cystic 12 (23%) 12 (24%) 13 (25%) 11 (21%) 6 (11%) 2 (3%) Hematopoietic Cell Proliferation 1 (2%) Hyperplasia 13 (25%) 7 (14%) 13 (25%) 12 (23%) 10 (19%) 5 (8%) Hypertrophy 45 (85%) 40 (78%) 47 (89%) 44 (83%) 45 (85%) 27 (42%) Inflammation 1 (2%) Necrosis 1 (2%) 2 (4%) 4 (8%) 1 (2%) 4 (6%) Vacuolization Cytoplasmic 14 (26%) 16 (31%) 13 (25%) 24 (45%) 27 (51%) 12 (18%) Adrenal Medulla (53) (51) (53) (53) (53) (64) Hyperplasia 13 (25%) 4 (8%) 9 (17%) 12 (23%) 2 (4%) Islets, Pancreatic (53) (51) (53) (53) (53) (65) Hyperplasia 1 (2%) Pituitary Gland (53) (51) (52) (53) (53) (65) Angiectasis 23 (43%) 13 (25%) 19 (37%) 7 (13%) Cyst 1 (2%) Cytoplasmic Alteration 1 (2%) 1 (2%) Necrosis 1 (2%) Vacuolization Cytoplasmic 2 (4%) 1 (2%) 5 (9%) Pars Distalis, Hyperplasia 11 (21%) 14 (27%) 19 (37%) 18 (34%) 4 (8%) 1 (2%) Thyroid Gland (53) (51) (53) (52) (52) (66) Hemorrhage 1 (2%) Inflammation 1 (2%) Artery, Inflammation, Chronic Active 1 (2%) C-Cell, Hyperplasia 7 (13%) 11 (22%) 13 (25%) 10 (19%) 15 (29%) 3 (5%) Follicle, Cyst 1 (2%) Follicular Cell, Hyperplasia 2 (4%) 1 (2%) Follicular Cell, Hypertrophy 22 (42%) 35 (69%) 34 (64%) 38 (73%) 44 (85%) 37 (56%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM a Number of animals examined microscopically at site and number of animals with lesion Page 5 NTP Experiment-Test: 96022-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC TEF EVALUATION (PCB MIXTURE;PCB 126/PCB 118) Date: 11/15/04 Route: GAVAGE Time: 11:11:28 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG ____________________________________________________________________________________________________________________________________ None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Clitoral Gland (53) (51) (51) (52) (52) (66) Inflammation 49 (92%) 44 (86%) 46 (90%) 34 (65%) 21 (40%) 31 (47%) Artery, Inflammation, Chronic Active 1 (2%) Duct, Cyst 40 (75%) 41 (80%) 43 (84%) 45 (87%) 48 (92%) 61 (92%) Ovary (53) (51) (53) (53) (53) (65) Atrophy 46 (87%) 34 (67%) 43 (81%) 42 (79%) 7 (13%) 9 (14%) Cyst 19 (36%) 12 (24%) 15 (28%) 19 (36%) 8 (15%) 13 (20%) Inflammation 3 (6%) 3 (6%) Inflammation, Chronic Active 1 (2%) 3 (6%) 3 (6%) Artery, Inflammation 1 (2%) Periovarian Tissue, Inflammation, Chronic Active 1 (2%) Oviduct (1) Cyst 1 (100%) Inflammation 1 (100%) Uterus (53) (51) (53) (53) (53) (66) Adenomyosis 1 (2%) 3 (6%) 1 (2%) Congestion 1 (2%) Hemorrhage 2 (4%) 1 (2%) Hyperplasia, Cystic 1 (2%) Inflammation, Chronic Active 2 (4%) 5 (10%) 2 (4%) 5 (9%) Inflammation, Suppurative 4 (8%) 3 (6%) 5 (9%) 7 (13%) 2 (3%) Metaplasia, Squamous 23 (43%) 24 (47%) 28 (53%) 24 (45%) Thrombosis 1 (2%) Endometrium, Hyperplasia, Cystic 32 (60%) 23 (45%) 25 (47%) 30 (57%) 7 (13%) 8 (12%) Serosa, Inflammation, Chronic Active 1 (2%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (53) (51) (53) (53) (53) (66) Atrophy 2 (4%) 12 (18%) Hyperplasia 37 (70%) 41 (80%) 36 (68%) 48 (91%) 47 (89%) 49 (74%) Lymph Node (28) (16) (16) (25) (20) (45) Hemorrhage 1 (4%) Deep Cervical, Congestion 1 (4%) Deep Cervical, Ectasia 1 (4%) Deep Cervical, Hemorrhage 1 (4%) a Number of animals examined microscopically at site and number of animals with lesion Page 6 NTP Experiment-Test: 96022-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC TEF EVALUATION (PCB MIXTURE;PCB 126/PCB 118) Date: 11/15/04 Route: GAVAGE Time: 11:11:28 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - CONT Deep Cervical, Hyperplasia, Histiocytic 1 (4%) Deep Cervical, Hyperplasia, Plasma Cell 1 (4%) Lumbar, Ectasia 1 (6%) 1 (4%) Lumbar, Hemorrhage 1 (4%) Lumbar, Hyperplasia, Plasma Cell 1 (6%) Mediastinal, Congestion 1 (4%) Mediastinal, Ectasia 7 (25%) 7 (44%) 7 (44%) 7 (28%) 7 (35%) 27 (60%) Mediastinal, Hemorrhage 2 (7%) 2 (13%) 4 (25%) 15 (60%) 7 (35%) 25 (56%) Mediastinal, Hyperplasia, Histiocytic 2 (8%) 2 (10%) 2 (4%) Mediastinal, Hyperplasia, Lymphoid 2 (13%) Mediastinal, Hyperplasia, Plasma Cell 3 (19%) 1 (4%) Mediastinal, Pigmentation 2 (4%) Pancreatic, Ectasia 1 (5%) 1 (2%) Pancreatic, Hemorrhage 1 (5%) 4 (9%) Pancreatic, Hyperplasia, Histiocytic 1 (4%) 4 (20%) 3 (7%) Pancreatic, Hyperplasia, Lymphoid 2 (8%) 1 (2%) Renal, Ectasia 1 (6%) 1 (4%) 1 (5%) Renal, Hemorrhage 1 (5%) Renal, Hyperplasia 1 (5%) Renal, Hyperplasia, Histiocytic 1 (5%) 2 (4%) Lymph Node, Mandibular (53) (51) (53) (52) (52) (66) Atrophy 1 (2%) Ectasia 3 (6%) 2 (4%) 3 (6%) 4 (8%) 4 (8%) 1 (2%) Hemorrhage 1 (2%) 2 (4%) 7 (11%) Hyperplasia, Histiocytic 1 (2%) Hyperplasia, Lymphoid 1 (2%) 3 (6%) 2 (4%) 1 (2%) Hyperplasia, Plasma Cell 45 (85%) 35 (69%) 34 (64%) 27 (52%) 22 (42%) 20 (30%) Necrosis 1 (2%) Necrosis, Lymphoid 1 (2%) Pigmentation 1 (2%) Lymph Node, Mesenteric (53) (51) (53) (53) (52) (65) Ectasia 1 (2%) 1 (2%) 2 (4%) 1 (2%) 2 (3%) Hemorrhage 2 (4%) 2 (4%) 2 (4%) 4 (8%) 14 (22%) Hyperplasia, Histiocytic 2 (4%) 1 (2%) 6 (11%) 5 (10%) Hyperplasia, Lymphoid 1 (2%) 1 (2%) Hyperplasia, Plasma Cell 1 (2%) Spleen (53) (51) (53) (53) (53) (65) Hematopoietic Cell Proliferation 49 (92%) 44 (86%) 49 (92%) 52 (98%) 50 (94%) 43 (66%) Pigmentation 52 (98%) 50 (98%) 52 (98%) 50 (94%) 50 (94%) 59 (91%) Artery, Inflammation, Chronic Active 1 (2%) Capsule, Fibrosis 1 (2%) Lymphoid Follicle, Atrophy 4 (8%) 5 (10%) 2 (4%) 5 (9%) 3 (6%) 9 (14%) Red Pulp, Atrophy 1 (2%) 2 (3%) a Number of animals examined microscopically at site and number of animals with lesion Page 7 NTP Experiment-Test: 96022-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC TEF EVALUATION (PCB MIXTURE;PCB 126/PCB 118) Date: 11/15/04 Route: GAVAGE Time: 11:11:28 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - CONT Thymus (53) (51) (51) (51) (51) (59) Atrophy 40 (75%) 44 (86%) 44 (86%) 49 (96%) 50 (98%) 57 (97%) Hemorrhage 2 (4%) Necrosis 1 (2%) Artery, Inflammation, Chronic Active 1 (2%) 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (53) (51) (53) (53) (53) (66) Cyst 1 (2%) 2 (4%) 2 (4%) 2 (4%) Hyperplasia 26 (49%) 17 (33%) 13 (25%) 6 (11%) 6 (11%) Inflammation 1 (2%) Inflammation, Granulomatous 3 (6%) 2 (4%) 1 (2%) Skin (53) (51) (53) (53) (53) (66) Cyst Epithelial Inclusion 1 (2%) 2 (4%) 1 (2%) Hemorrhage 1 (2%) Inflammation 1 (2%) 1 (2%) Ulcer 1 (2%) Subcutaneous Tissue, Inflammation, Chronic Active 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM None ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (53) (51) (53) (53) (53) (66) Hemorrhage 1 (2%) 1 (2%) 4 (8%) 5 (9%) 14 (21%) Hydrocephalus 1 (2%) Inflammation 2 (4%) 1 (2%) Mineralization 1 (2%) Necrosis 2 (4%) 1 (2%) Artery, Inflammation, Chronic Active 1 (2%) Cerebrum, Degeneration 1 (2%) Meninges, Inflammation 1 (2%) Meninges, Vein, Thrombosis 1 (2%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 8 NTP Experiment-Test: 96022-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC TEF EVALUATION (PCB MIXTURE;PCB 126/PCB 118) Date: 11/15/04 Route: GAVAGE Time: 11:11:28 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (53) (51) (53) (53) (53) (66) Congestion 2 (4%) Hemorrhage 1 (2%) 2 (4%) 4 (6%) Infiltration Cellular, Histiocyte 40 (75%) 33 (65%) 46 (87%) 48 (91%) 46 (87%) 33 (50%) Inflammation 5 (9%) 9 (18%) 7 (13%) 3 (6%) 2 (4%) 2 (3%) Metaplasia, Squamous 1 (2%) 2 (4%) 14 (26%) 16 (30%) 7 (11%) Necrosis 1 (2%) Alveolar Epithelium, Hyperplasia 18 (34%) 10 (20%) 2 (4%) 1 (2%) 1 (2%) 4 (6%) Alveolar Epithelium, Metaplasia, Bronchiolar 1 (2%) 14 (27%) 39 (74%) 46 (87%) 35 (66%) 8 (12%) Artery, Thrombosis 1 (2%) Artery, Mediastinum, Inflammation, Chronic Active 1 (2%) Mediastinum, Inflammation 1 (2%) Serosa, Fibrosis 3 (6%) 1 (2%) 16 (30%) 8 (12%) Nose (53) (51) (53) (53) (53) (66) Inflammation 17 (32%) 15 (29%) 16 (30%) 10 (19%) 22 (42%) 11 (17%) Necrosis 1 (2%) Ulcer 1 (2%) Glands, Hyperplasia 2 (4%) Olfactory Epithelium, Degeneration 1 (2%) Olfactory Epithelium, Metaplasia 2 (4%) 1 (2%) 3 (6%) 8 (15%) 1 (2%) Respiratory Epithelium, Hyperplasia 8 (15%) 11 (22%) 5 (9%) 8 (15%) 16 (30%) 9 (14%) Squamous Epithelium, Hyperplasia 1 (2%) 2 (4%) 1 (2%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (53) (51) (53) (53) (53) (66) Cataract 1 (2%) 3 (6%) Cornea, Inflammation 1 (2%) 1 (2%) 1 (2%) Iris, Inflammation 1 (2%) Retina, Atrophy 1 (2%) 3 (6%) 1 (2%) 1 (2%) Retina, Degeneration 1 (2%) Harderian Gland (53) (51) (53) (53) (53) (66) Inflammation 24 (45%) 7 (14%) 20 (38%) 13 (25%) 7 (13%) 9 (14%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (53) (51) (53) (53) (53) (65) Calculus Micro Observation Only 6 (11%) 6 (12%) 6 (11%) Cyst 2 (4%) a Number of animals examined microscopically at site and number of animals with lesion Page 9 NTP Experiment-Test: 96022-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC TEF EVALUATION (PCB MIXTURE;PCB 126/PCB 118) Date: 11/15/04 Route: GAVAGE Time: 11:11:28 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG ____________________________________________________________________________________________________________________________________ URINARY SYSTEM - CONT Infarct 2 (4%) 1 (2%) Inflammation, Chronic Active 1 (2%) Inflammation, Suppurative 1 (2%) 4 (8%) 3 (6%) 1 (2%) Mineralization 46 (87%) 34 (67%) 38 (72%) 44 (83%) 34 (64%) 37 (57%) Necrosis 1 (2%) Nephropathy 41 (77%) 37 (73%) 37 (70%) 48 (91%) 50 (94%) 43 (66%) Pigmentation 1 (2%) Artery, Inflammation, Chronic Active 1 (2%) Pelvis, Dilatation 1 (2%) Pelvis, Inflammation 4 (8%) 6 (12%) 1 (2%) 6 (11%) Renal Tubule, Hyperplasia 2 (4%) Transitional Epithelium, Hyperplasia 4 (8%) 6 (12%) 6 (11%) 16 (30%) 1 (2%) Transitional Epithelium, Metaplasia, Squamous 1 (2%) Ureter (1) Transitional Epithelium, Hyperplasia 1 (100%) Urinary Bladder (53) (51) (53) (53) (52) (66) Calculus Gross Observation 1 (2%) Edema 1 (2%) Inflammation 8 (15%) 3 (6%) 2 (4%) 4 (8%) 1 (2%) Metaplasia, Squamous 1 (2%) Artery, Inflammation, Chronic Active 1 (2%) Transitional Epithelium, Hyperplasia 4 (8%) 2 (4%) 4 (8%) 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 10 NTP Experiment-Test: 96022-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC TEF EVALUATION (PCB MIXTURE;PCB 126/PCB 118) Date: 11/15/04 Route: GAVAGE Time: 11:11:28 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 360 NG TEQKG ST ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 50 Early Deaths Moribund Sacrifice 28 Natural Death 12 Survivors Terminal Sacrifice 10 Animals Examined Microscopically 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Colon (50) Parasite Metazoan 1 (2%) Intestine Large, Rectum (50) Parasite Metazoan 1 (2%) Artery, Inflammation, Chronic Active 4 (8%) Intestine Large, Cecum (50) Edema 1 (2%) Inflammation 1 (2%) Artery, Inflammation, Chronic Active 1 (2%) Intestine Small, Ileum (50) Parasite Metazoan 1 (2%) Liver (50) Angiectasis 4 (8%) Basophilic Focus 2 (4%) Basophilic Focus, Multiple 3 (6%) Cholangiofibrosis 27 (54%) Clear Cell Focus 1 (2%) Degeneration, Cystic 1 (2%) Eosinophilic Focus 1 (2%) Eosinophilic Focus, Multiple 14 (28%) Fatty Change, Diffuse 35 (70%) Fatty Change, Focal 14 (28%) Hematopoietic Cell Proliferation 22 (44%) Hemorrhage 1 (2%) Hepatodiaphragmatic Nodule 1 (2%) Hyperplasia, Nodular 34 (68%) Inflammation 48 (96%) Metaplasia 2 (4%) Mixed Cell Focus 1 (2%) Mixed Cell Focus, Multiple 19 (38%) a Number of animals examined microscopically at site and number of animals with lesion Page 11 NTP Experiment-Test: 96022-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC TEF EVALUATION (PCB MIXTURE;PCB 126/PCB 118) Date: 11/15/04 Route: GAVAGE Time: 11:11:28 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 360 NG TEQKG ST ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Necrosis 6 (12%) Pigmentation 50 (100%) Toxic Hepatopathy 50 (100%) Bile Duct, Cyst 21 (42%) Bile Duct, Fibrosis 12 (24%) Bile Duct, Hyperplasia 37 (74%) Centrilobular, Degeneration 6 (12%) Centrilobular, Fibrosis 43 (86%) Hepatocyte, Glandular Structures 9 (18%) Hepatocyte, Hypertrophy 36 (72%) Hepatocyte, Multinucleated 38 (76%) Oval Cell, Hyperplasia 43 (86%) Portal, Fibrosis 42 (84%) Serosa, Fibrosis 1 (2%) Mesentery (43) Necrosis 1 (2%) Artery, Inflammation, Chronic Active 7 (16%) Oral Mucosa (50) Gingival, Hyperplasia, Squamous 18 (36%) Pancreas (50) Edema 12 (24%) Hemorrhage 1 (2%) Inflammation, Chronic Active 5 (10%) Acinus, Atrophy 8 (16%) Acinus, Vacuolization Cytoplasmic 41 (82%) Artery, Inflammation, Chronic Active 10 (20%) Stomach, Forestomach (50) Edema 1 (2%) Hyperplasia, Squamous 2 (4%) Inflammation 2 (4%) Mineralization 1 (2%) Ulcer 2 (4%) Stomach, Glandular (50) Mineralization 1 (2%) Artery, Inflammation, Chronic Active 1 (2%) Tooth (23) Peridontal Tissue, Inflammation 23 (100%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Blood Vessel (50) Aorta, Adventitia, Hemorrhage 2 (4%) a Number of animals examined microscopically at site and number of animals with lesion Page 12 NTP Experiment-Test: 96022-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC TEF EVALUATION (PCB MIXTURE;PCB 126/PCB 118) Date: 11/15/04 Route: GAVAGE Time: 11:11:28 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 360 NG TEQKG ST ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM - CONT Aorta, Adventitia, Inflammation 2 (4%) Heart (50) Cardiomyopathy 15 (30%) Atrium, Thrombosis 1 (2%) Coronary Artery, Inflammation, Chronic Active 6 (12%) Epicardium, Inflammation 1 (2%) Myocardium, Hemorrhage 1 (2%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (50) Angiectasis 21 (42%) Atrophy 12 (24%) Degeneration, Cystic 9 (18%) Hyperplasia 10 (20%) Hypertrophy 29 (58%) Inflammation 2 (4%) Necrosis 2 (4%) Vacuolization Cytoplasmic 16 (32%) Adrenal Medulla (49) Hyperplasia 8 (16%) Pituitary Gland (50) Angiectasis 3 (6%) Cyst 3 (6%) Cytoplasmic Alteration 2 (4%) Pars Distalis, Hyperplasia 8 (16%) Pars Intermedia, Hyperplasia 1 (2%) Thyroid Gland (49) Infiltration Cellular, Lymphoid 2 (4%) C-Cell, Hyperplasia 6 (12%) Follicular Cell, Hypertrophy 29 (59%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Clitoral Gland (50) Inflammation 30 (60%) a Number of animals examined microscopically at site and number of animals with lesion Page 13 NTP Experiment-Test: 96022-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC TEF EVALUATION (PCB MIXTURE;PCB 126/PCB 118) Date: 11/15/04 Route: GAVAGE Time: 11:11:28 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 360 NG TEQKG ST ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM - CONT Duct, Cyst 40 (80%) Ovary (50) Atrophy 15 (30%) Cyst 7 (14%) Uterus (50) Congestion 1 (2%) Hemorrhage 1 (2%) Inflammation, Chronic Active 1 (2%) Inflammation, Suppurative 4 (8%) Metaplasia, Squamous 8 (16%) Cervix, Stromal Hyperplasia 1 (2%) Endometrium, Hyperplasia, Cystic 17 (34%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (50) Atrophy 4 (8%) Hyperplasia 40 (80%) Lymph Node (22) Lumbar, Hemorrhage 1 (5%) Lumbar, Hyperplasia, Histiocytic 1 (5%) Mediastinal, Ectasia 3 (14%) Mediastinal, Hemorrhage 11 (50%) Mediastinal, Hyperplasia, Histiocytic 4 (18%) Mediastinal, Hyperplasia, Lymphoid 1 (5%) Mediastinal, Hyperplasia, Plasma Cell 1 (5%) Pancreatic, Hemorrhage 3 (14%) Pancreatic, Hyperplasia, Histiocytic 3 (14%) Pancreatic, Hyperplasia, Lymphoid 1 (5%) Renal, Ectasia 1 (5%) Renal, Hemorrhage 2 (9%) Renal, Hyperplasia, Histiocytic 3 (14%) Lymph Node, Mandibular (49) Ectasia 11 (22%) Hemorrhage 4 (8%) Hyperplasia, Plasma Cell 28 (57%) Inflammation 1 (2%) Lymph Node, Mesenteric (50) Ectasia 1 (2%) Hemorrhage 10 (20%) Hyperplasia, Histiocytic 1 (2%) Hyperplasia, Plasma Cell 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 14 NTP Experiment-Test: 96022-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC TEF EVALUATION (PCB MIXTURE;PCB 126/PCB 118) Date: 11/15/04 Route: GAVAGE Time: 11:11:28 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 360 NG TEQKG ST ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - CONT Spleen (50) Hematopoietic Cell Proliferation 45 (90%) Pigmentation 41 (82%) Lymphoid Follicle, Atrophy 4 (8%) Thymus (46) Atrophy 45 (98%) Hemorrhage 1 (2%) Artery, Inflammation, Chronic Active 1 (2%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (50) Cyst 1 (2%) Hyperplasia 11 (22%) Inflammation, Granulomatous 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (50) Tarsal, Inflammation 1 (2%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) Hemorrhage 8 (16%) Mineralization 1 (2%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) Hemorrhage 3 (6%) Infiltration Cellular, Histiocyte 24 (48%) Inflammation 6 (12%) Inflammation, Granulomatous 4 (8%) Keratin Cyst 9 (18%) Metaplasia, Squamous 8 (16%) Alveolar Epithelium, Hyperplasia 5 (10%) Alveolar Epithelium, Metaplasia, Bronchiolar 15 (30%) Serosa, Fibrosis 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 15 NTP Experiment-Test: 96022-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC TEF EVALUATION (PCB MIXTURE;PCB 126/PCB 118) Date: 11/15/04 Route: GAVAGE Time: 11:11:28 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 360 NG TEQKG ST ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM - CONT Nose (50) Inflammation 11 (22%) Olfactory Epithelium, Metaplasia 5 (10%) Respiratory Epithelium, Hyperplasia 10 (20%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (50) Retina, Atrophy 1 (2%) Harderian Gland (50) Inflammation 12 (24%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) Accumulation, Hyaline Droplet 1 (2%) Cyst 1 (2%) Mineralization 32 (64%) Nephropathy 34 (68%) Urinary Bladder (50) Inflammation 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 16 ------------------------------------------------------------ ---------- END OF REPORT ---------- ------------------------------------------------------------