NTP Experiment-Test: 96022-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18 Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 11/15/04 Route: GAVAGE TEF EVALUATION (PCB MIXTURE;PCB 126/PCB 118) Time: 11:25:25 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 b Average severity grade (1-minimal;2-mild;3-moderate;4-marked) Page 1 NTP Experiment-Test: 96022-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18 Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 11/15/04 Route: GAVAGE TEF EVALUATION (PCB MIXTURE;PCB 126/PCB 118) Time: 11:25:25 ____________________________________________________________________________________________________________________________________ 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 [3.0] Muscularis, Inflammation 3 [2.0] 2 [2.0] 3 [1.3] 3 [1.7] 2 [2.5] Intestine Large, Colon (53) (51) (53) (53) (52) (65) Parasite Metazoan 2 1 2 Artery, Inflammation, Chronic Active 1 [2.0] 1 [3.0] Intestine Large, Rectum (52) (51) (53) (53) (52) (66) Hyperplasia, Cystic 1 [2.0] Parasite Metazoan 3 2 2 2 1 Artery, Inflammation, Chronic Active 1 [3.0] 1 [3.0] 3 [3.0] 1 [3.0] Intestine Large, Cecum (53) (51) (53) (53) (52) (65) Edema 2 [2.0] Inflammation 2 [2.0] Artery, Inflammation, Chronic Active 2 [3.0] Intestine Small, Duodenum (53) (51) (53) (53) (53) (65) Dilatation 1 [3.0] Erosion 1 [2.0] Hyperplasia 1 [3.0] Artery, Inflammation, Chronic Active 1 [2.0] Intestine Small, Ileum (53) (51) (53) (53) (52) (65) Parasite Metazoan 1 Liver (53) (51) (53) (53) (53) (65) Angiectasis 1 [2.0] 2 [1.0] 1 [2.0] 3 [2.0] 2 [2.5] Basophilic Focus 14 8 6 5 4 Basophilic Focus, Multiple 13 8 4 3 Cholangiofibrosis 1 [3.0] 2 [1.0] 3 [1.0] 21 [2.2] 42 [3.4] 29 [3.2] Clear Cell Focus 4 1 Clear Cell Focus, Multiple 1 1 Degeneration, Cystic 1 [1.0] 1 [2.0] a Number of animals examined microscopically at site and number of animals with lesion b Average severity grade (1-minimal;2-mild;3-moderate;4-marked) Page 2 NTP Experiment-Test: 96022-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18 Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 11/15/04 Route: GAVAGE TEF EVALUATION (PCB MIXTURE;PCB 126/PCB 118) Time: 11:25:25 ____________________________________________________________________________________________________________________________________ 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 5 11 1 2 Eosinophilic Focus, Multiple 5 16 12 14 4 10 Fatty Change, Diffuse 3 [1.3] 14 [1.0] 27 [1.2] 45 [1.5] 49 [1.7] 56 [1.8] Fatty Change, Focal 10 [1.3] 10 [1.4] 6 [1.7] 1 [2.0] 10 [2.6] 6 [2.2] Hematopoietic Cell Proliferation 27 [1.1] 27 [1.0] 30 [1.0] 32 [1.0] 22 [1.1] 11 [1.0] Hepatodiaphragmatic Nodule 2 2 2 Hyperplasia, Nodular 10 45 50 61 Inflammation 49 [1.0] 47 [1.2] 50 [1.1] 52 [1.4] 51 [1.2] 64 [1.4] Metaplasia 4 [1.0] 4 [2.0] Mineralization 1 [2.0] Mixed Cell Focus 5 5 4 1 3 Mixed Cell Focus, Multiple 33 23 28 16 1 Necrosis 3 [1.3] 13 [2.2] 6 [2.0] 26 [2.0] 17 [2.4] 27 [2.2] Pigmentation 5 [1.0] 18 [1.4] 38 [1.6] 52 [2.1] 53 [2.0] 60 [2.0] Thrombosis 1 [2.0] Toxic Hepatopathy 8 [1.1] 32 [1.2] 51 [2.6] 52 [3.5] 64 [3.6] Artery, Inflammation 1 [1.0] 1 [3.0] Bile Duct, Cyst 4 [2.3] 3 [3.0] 3 [2.3] 14 [2.1] 25 [2.2] 14 [1.9] Bile Duct, Dilatation 1 [2.0] Bile Duct, Fibrosis 6 [1.7] 2 [1.0] 3 [1.3] 10 [1.7] 3 [2.0] 4 [1.5] Bile Duct, Hyperplasia 5 [1.0] 5 [1.2] 7 [1.9] 46 [1.8] 52 [1.9] 60 [2.4] Centrilobular, Degeneration 2 [2.5] 3 [2.0] 8 [1.9] 8 [2.0] 3 [2.3] 8 [1.9] Centrilobular, Fibrosis 7 [1.0] 36 [1.6] 52 [1.9] 57 [2.1] Hepatocyte, Glandular Structures 1 [1.0] 5 [1.2] 25 [2.2] Hepatocyte, Hypertrophy 16 [1.1] 22 [1.4] 47 [2.6] 52 [3.2] 65 [3.5] Hepatocyte, Multinucleated 9 [1.3] 21 [1.2] 48 [1.8] 52 [1.9] 48 [1.7] Oval Cell, Hyperplasia 4 [1.0] 4 [1.0] 23 [1.2] 49 [2.1] 52 [3.0] 62 [3.0] Portal, Fibrosis 2 [1.0] 37 [1.8] 52 [2.7] 58 [2.9] Serosa, Inflammation 2 [2.5] Mesentery (53) (35) (45) (49) (52) (63) Inflammation 1 [3.0] Necrosis 1 [3.0] 1 [3.0] Artery, Inflammation, Chronic Active 1 [3.0] 1 [4.0] 9 [2.7] 9 [2.1] 3 [1.7] Fat, Necrosis 1 [3.0] 3 [2.3] 3 [2.7] Oral Mucosa (53) (51) (53) (53) (53) (66) Cyst 1 [2.0] Gingival, Hyperplasia, Squamous 11 [1.1] 10 [1.2] 20 [1.4] 24 [1.8] 27 [1.7] 18 [1.6] Pancreas (53) (51) (53) (53) (53) (65) Edema 1 [2.0] 4 [1.8] 19 [1.8] Hemorrhage 2 [2.5] Inflammation, Chronic Active 1 [1.0] 5 [1.8] 4 [1.5] 3 [1.3] 2 [1.5] 6 [1.8] Lipomatosis 1 [2.0] 1 [2.0] Acinus, Atrophy 1 [1.0] 5 [1.8] 3 [1.3] 5 [1.8] 9 [1.2] 8 [1.8] a Number of animals examined microscopically at site and number of animals with lesion b Average severity grade (1-minimal;2-mild;3-moderate;4-marked) Page 3 NTP Experiment-Test: 96022-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18 Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 11/15/04 Route: GAVAGE TEF EVALUATION (PCB MIXTURE;PCB 126/PCB 118) Time: 11:25:25 ____________________________________________________________________________________________________________________________________ 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 [1.5] Acinus, Hyperplasia, Focal 1 [2.0] Acinus, Vacuolization Cytoplasmic 1 [1.0] 8 [1.0] 39 [1.6] 49 [1.9] 43 [1.6] Artery, Inflammation, Chronic Active 2 [3.0] 2 [2.0] 21 [2.3] 14 [2.6] 4 [2.3] Duct, Dilatation 1 [2.0] 3 [3.0] Salivary Glands (53) (51) (53) (52) (52) (66) Atrophy 1 [2.0] Stomach, Forestomach (53) (51) (53) (53) (53) (65) Edema 2 [2.5] 1 [2.0] Erosion 1 [2.0] 1 [2.0] Hemorrhage 1 [2.0] Hyperplasia, Squamous 4 [1.5] 1 [2.0] 3 [2.3] 11 [2.0] 4 [1.8] 9 [1.9] Inflammation 2 [3.0] 2 [2.5] 4 [1.8] 1 [1.0] Mineralization 1 [1.0] 2 [1.0] Ulcer 2 [2.0] 1 [3.0] 1 [2.0] 1 [1.0] Artery, Inflammation, Chronic Active 2 [2.5] Stomach, Glandular (53) (51) (53) (53) (53) (65) Cyst 1 [2.0] Erosion 1 [2.0] 1 [2.0] 2 [2.0] Hemorrhage 1 [2.0] 3 [1.7] Inflammation 1 [1.0] Mineralization 12 [1.3] 6 [1.3] 6 [1.5] 1 [2.0] 6 [1.2] 5 [1.6] Glands, Cyst 1 [3.0] Tongue (1) Cyst 1 [2.0] Tooth (29) (26) (33) (34) (29) (25) Peridontal Tissue, Inflammation 29 [1.6] 26 [1.2] 33 [1.2] 34 [1.8] 29 [1.3] 25 [1.4] ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Blood Vessel (53) (51) (52) (53) (53) (66) Mineralization 1 [1.0] Aorta, Adventitia, Hemorrhage 1 [2.0] 1 [2.0] Aorta, Adventitia, Inflammation 1 [3.0] 2 [2.0] Heart (53) (51) (53) (53) (53) (65) Cardiomyopathy 20 [1.2] 13 [1.1] 17 [1.0] 34 [1.1] 14 [1.0] 19 [1.3] Atrium, Thrombosis 1 [3.0] Coronary Artery, Inflammation, Chronic Active 1 [1.0] 1 [2.0] 7 [2.0] 10 [2.7] 9 [2.4] Coronary Artery, Thrombosis 1 [2.0] Endocardium, Hyperplasia 1 [3.0] Epicardium, Hemorrhage 1 [2.0] Epicardium, Inflammation 1 [1.0] 1 [2.0] 6 [1.2] 13 [1.5] 6 [1.5] a Number of animals examined microscopically at site and number of animals with lesion b Average severity grade (1-minimal;2-mild;3-moderate;4-marked) Page 4 NTP Experiment-Test: 96022-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18 Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 11/15/04 Route: GAVAGE TEF EVALUATION (PCB MIXTURE;PCB 126/PCB 118) Time: 11:25:25 ____________________________________________________________________________________________________________________________________ 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 [2.0] Myocardium, Inflammation 1 [2.0] Myocardium, Necrosis 2 [2.5] Pericardium, Inflammation, Chronic Active 1 [4.0] Valve, Fibrosis 1 [2.0] Valve, Hyperplasia 1 [4.0] Ventricle, Thrombosis 1 [3.0] ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (53) (51) (53) (53) (53) (65) Angiectasis 42 [1.6] 35 [1.4] 39 [1.6] 25 [1.3] 4 [1.0] 6 [1.0] Atrophy 2 [3.0] 1 [4.0] 15 [2.4] 44 [2.4] 40 [2.4] Degeneration, Cystic 12 [2.2] 12 [2.3] 13 [1.8] 11 [2.1] 6 [2.2] 2 [1.5] Hematopoietic Cell Proliferation 1 [1.0] Hyperplasia 13 [2.0] 7 [2.1] 13 [2.1] 12 [2.1] 10 [2.2] 5 [2.0] Hypertrophy 45 [2.0] 40 [2.1] 47 [2.1] 44 [2.3] 45 [2.0] 27 [1.6] Inflammation 1 [3.0] Necrosis 1 [4.0] 2 [2.0] 4 [2.3] 1 [2.0] 4 [2.0] Vacuolization Cytoplasmic 14 [1.6] 16 [1.6] 13 [1.5] 24 [1.7] 27 [1.7] 12 [1.5] Adrenal Medulla (53) (51) (53) (53) (53) (64) Hyperplasia 13 [1.8] 4 [2.5] 9 [2.3] 12 [2.1] 2 [2.0] Islets, Pancreatic (53) (51) (53) (53) (53) (65) Hyperplasia 1 [2.0] Pituitary Gland (53) (51) (52) (53) (53) (65) Angiectasis 23 [2.2] 13 [2.2] 19 [2.3] 7 [2.4] Cyst 1 [2.0] Cytoplasmic Alteration 1 [1.0] 1 [1.0] Necrosis 1 [2.0] Vacuolization Cytoplasmic 2 [2.0] 1 [1.0] 5 [1.0] Pars Distalis, Hyperplasia 11 [2.4] 14 [2.6] 19 [2.1] 18 [2.3] 4 [2.3] 1 [2.0] Thyroid Gland (53) (51) (53) (52) (52) (66) Hemorrhage 1 [3.0] Inflammation 1 [3.0] Artery, Inflammation, Chronic Active 1 [3.0] C-Cell, Hyperplasia 7 [1.4] 11 [2.3] 13 [1.8] 10 [2.0] 15 [1.8] 3 [2.0] Follicle, Cyst 1 [3.0] Follicular Cell, Hyperplasia 2 [2.5] 1 [2.0] Follicular Cell, Hypertrophy 22 [1.2] 35 [1.4] 34 [1.8] 38 [1.8] 44 [1.9] 37 [1.7] ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM a Number of animals examined microscopically at site and number of animals with lesion b Average severity grade (1-minimal;2-mild;3-moderate;4-marked) Page 5 NTP Experiment-Test: 96022-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18 Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 11/15/04 Route: GAVAGE TEF EVALUATION (PCB MIXTURE;PCB 126/PCB 118) Time: 11:25:25 ____________________________________________________________________________________________________________________________________ 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 [1.9] 44 [1.6] 46 [1.4] 34 [1.2] 21 [1.1] 31 [1.1] Artery, Inflammation, Chronic Active 1 [3.0] Duct, Cyst 40 [2.2] 41 [2.2] 43 [2.1] 45 [2.3] 48 [2.4] 61 [2.4] Ovary (53) (51) (53) (53) (53) (65) Atrophy 46 [3.0] 34 [3.1] 43 [3.0] 42 [3.0] 7 [3.0] 9 [3.0] Cyst 19 [2.2] 12 [2.3] 15 [2.3] 19 [2.3] 8 [1.9] 13 [2.1] Inflammation 3 [3.3] 3 [3.3] Inflammation, Chronic Active 1 [3.0] 3 [4.0] 3 [4.0] Artery, Inflammation 1 [4.0] Periovarian Tissue, Inflammation, Chronic Active 1 [3.0] Oviduct (1) Cyst 1 [3.0] Inflammation 1 [3.0] Uterus (53) (51) (53) (53) (53) (66) Adenomyosis 1 [3.0] 3 [2.7] 1 [2.0] Congestion 1 [1.0] Hemorrhage 2 [3.5] 1 [3.0] Hyperplasia, Cystic 1 [1.0] Inflammation, Chronic Active 2 [1.0] 5 [1.8] 2 [3.0] 5 [3.2] Inflammation, Suppurative 4 [1.5] 3 [2.3] 5 [1.4] 7 [3.0] 2 [2.5] Metaplasia, Squamous 23 [1.7] 24 [2.4] 28 [2.4] 24 [2.5] Thrombosis 1 [2.0] Endometrium, Hyperplasia, Cystic 32 [2.1] 23 [2.0] 25 [2.2] 30 [2.2] 7 [2.4] 8 [2.0] Serosa, Inflammation, Chronic Active 1 [4.0] ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM