TDMS Study 96007-03 Pathology Tables
NTP Experiment-Test: 96007-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18 Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 09/30/03 Route: GAVAGE TOXIC EQUIVALENCY FACTOR EVALUATION (TCDD) Time: 09:06:07 FINAL # 3 RATS Facility: Battelle Columbus Laboratory Chemical CAS #: 1746-01-6 Lock Date: 06/28/01 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: 96007-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18 Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 09/30/03 Route: GAVAGE TOXIC EQUIVALENCY FACTOR EVALUATION (TCDD) Time: 09:06:07 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 0 NG/KG 3 NG/KG 10 NG/KG 22 NG/KG 46 NG/KG 100 NG/KG ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 98 98 98 98 98 98 Early Deaths Moribund Sacrifice 19 27 15 19 17 17 Natural Death 9 6 10 15 14 15 Dosing Accident 5 Survivors Terminal Sacrifice 25 21 23 19 22 21 Animals Examined Microscopically 53 54 53 53 53 53 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Esophagus (52) (54) (53) (52) (53) (53) Hemorrhage 1 [4.0] Perforation 2 Muscularis, Inflammation 1 [2.0] 2 [2.5] 1 [2.0] 1 [2.0] 2 [1.5] Periesophageal Tissue, Inflammation 3 [2.7] Intestine Large, Colon (52) (53) (53) (53) (53) (51) Parasite Metazoan 1 2 1 2 Intestine Large, Rectum (52) (54) (53) (52) (53) (53) Parasite Metazoan 6 4 2 1 Intestine Small, Duodenum (53) (54) (53) (52) (53) (53) Cyst 1 [2.0] Ulcer 1 [3.0] Epithelium, Hyperplasia 1 [1.0] Liver (53) (54) (53) (53) (53) (53) Angiectasis 2 [1.5] 1 [1.0] 1 [1.0] 3 [1.7] 5 [2.0] Basophilic Focus 8 6 8 7 3 3 Basophilic Focus, Multiple 4 3 5 1 2 5 Cholangiofibrosis 1 [1.0] 1 [1.0] 2 [1.5] 1 [1.0] 11 [2.5] 31 [2.4] Clear Cell Focus 4 1 1 2 1 1 Clear Cell Focus, Multiple 1 2 1 1 Congestion 2 [1.0] 2 [2.0] Cytoplasmic Alteration 2 [2.0] Degeneration, Cystic 2 [1.0] 4 [2.3] Eosinophilic Focus 8 6 7 10 5 2 Eosinophilic Focus, Multiple 3 8 14 17 22 42 Fatty Change, Diffuse 2 [1.0] 12 [1.1] 17 [1.3] 30 [1.2] 48 [1.9] Fatty Change, Focal 2 [1.5] 6 [1.5] 4 [1.5] 4 [1.8] 1 [1.0] 2 [2.0] Hematopoietic Cell Proliferation 1 [2.0] 2 [1.0] 2 [1.0] 4 [1.5] 2 [2.0] 2 [2.0] Hemorrhage 1 [3.0] 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: 96007-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18 Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 09/30/03 Route: GAVAGE TOXIC EQUIVALENCY FACTOR EVALUATION (TCDD) Time: 09:06:07 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 0 NG/KG 3 NG/KG 10 NG/KG 22 NG/KG 46 NG/KG 100 NG/KG ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Hepatodiaphragmatic Nodule 2 1 2 Hyperplasia, Nodular 3 7 36 Inflammation 33 [1.1] 46 [1.2] 47 [1.1] 50 [1.4] 52 [1.2] 49 [1.3] Mitotic Alteration 1 [2.0] 1 [2.0] Mixed Cell Focus 4 8 8 2 4 Mixed Cell Focus, Multiple 26 11 21 23 28 17 Necrosis 1 [2.0] 4 [2.3] 4 [2.0] 8 [2.3] 10 [1.9] 17 [2.5] Pigmentation 4 [1.0] 9 [1.2] 34 [1.4] 48 [1.7] 52 [2.0] 53 [2.2] Thrombosis 1 [3.0] Toxic Hepatopathy 2 [1.0] 8 [1.3] 30 [1.2] 45 [1.8] 53 [3.5] Artery, Inflammation, Chronic Active 2 [2.0] Bile Duct, Cyst 3 [3.3] 1 [3.0] 2 [2.0] 2 [1.5] 21 [2.9] Bile Duct, Fibrosis 2 [2.0] 1 [2.0] 3 [1.3] 4 [1.8] Bile Duct, Hyperplasia 5 [1.6] 4 [1.5] 7 [1.1] 22 [1.3] 40 [1.4] 53 [2.1] Centrilobular, Degeneration 2 [2.5] 2 [2.0] 4 [2.3] 3 [2.0] 5 [2.0] Hepatocyte, Hypertrophy 19 [1.2] 19 [1.2] 42 [1.5] 41 [2.0] 52 [3.2] Hepatocyte, Multinucleated 16 [1.2] 26 [1.2] 36 [1.4] 51 [1.8] Hepatocyte, Centrilobular, Atrophy 1 [2.0] Oval Cell, Hyperplasia 4 [1.0] 3 [1.3] 20 [1.3] 38 [1.5] 53 [2.3] Portal, Fibrosis 5 [1.8] 27 [2.0] Mesentery (2) (2) (1) (6) (8) Metaplasia, Osseous 1 [2.0] Artery, Inflammation, Chronic Active 1 [3.0] 4 [2.3] 7 [2.7] Fat, Necrosis 1 [3.0] 1 [3.0] 1 [3.0] 1 [3.0] Vein, Thrombosis 1 [3.0] Oral Mucosa (2) (9) (16) (16) (22) (29) Gingival, Hyperplasia, Squamous 1 [4.0] 7 [1.4] 14 [1.6] 13 [1.6] 15 [2.2] 16 [2.3] Pancreas (51) (54) (52) (53) (52) (51) Hemorrhage 1 [3.0] Inflammation, Acute 1 [4.0] Inflammation, Chronic Active 2 [1.5] 2 [1.0] 3 [1.3] 6 [2.0] Necrosis 1 [3.0] 1 [2.0] Acinus, Atrophy 1 [1.0] 2 [1.5] 4 [1.5] 4 [1.5] 4 [1.5] 9 [2.2] Acinus, Hyperplasia 2 [2.5] 1 [2.0] 2 [2.5] Acinus, Vacuolization Cytoplasmic 1 [2.0] 1 [1.0] 15 [1.1] 42 [1.8] Artery, Inflammation, Chronic Active 1 [3.0] 1 [2.0] 2 [2.5] 2 [3.0] 7 [2.3] Salivary Glands (51) (54) (52) (50) (51) (52) Atrophy 2 [2.5] 1 [2.0] Inflammation 2 [2.0] 3 [2.3] 1 [3.0] Mineralization 1 [3.0] Stomach, Forestomach (53) (54) (53) (53) (53) (53) Cyst, Squamous 1 [2.0] Edema 1 [2.0] 1 [1.0] 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 3 NTP Experiment-Test: 96007-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18 Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 09/30/03 Route: GAVAGE TOXIC EQUIVALENCY FACTOR EVALUATION (TCDD) Time: 09:06:07 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 0 NG/KG 3 NG/KG 10 NG/KG 22 NG/KG 46 NG/KG 100 NG/KG ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Erosion 1 [2.0] 1 [2.0] Hyperkeratosis 1 [1.0] 1 [1.0] 1 [1.0] 1 [3.0] 2 [2.0] 3 [2.0] Hyperplasia, Squamous 3 [1.3] 4 [1.5] 4 [1.8] 2 [2.0] 7 [2.1] 11 [1.7] Inflammation 1 [3.0] 1 [2.0] 2 [1.5] 2 [1.5] 5 [1.8] Mineralization 1 [2.0] Necrosis 1 [1.0] Ulcer 2 [2.5] 1 [2.0] 1 [1.0] 1 [2.0] 4 [2.5] Stomach, Glandular (53) (54) (53) (53) (53) (53) Diverticulum 1 Erosion 1 [3.0] Metaplasia 1 [2.0] Mineralization 3 [1.3] 1 [2.0] 3 [1.7] Ulcer 2 [2.5] Tooth (16) (16) (12) (13) (14) (18) Peridontal Tissue, Fibrosis 1 [2.0] Peridontal Tissue, Inflammation 15 [1.7] 16 [1.2] 12 [1.3] 13 [1.4] 14 [1.6] 18 [1.6] ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Blood Vessel (53) (54) (53) (53) (53) (53) Thrombosis 1 [4.0] Aorta, Mineralization 1 [3.0] 1 [2.0] 1 [2.0] Heart (53) (54) (53) (52) (53) (52) Cardiomyopathy 10 [1.2] 12 [1.0] 22 [1.0] 25 [1.1] 32 [1.1] 36 [1.3] Mineralization 1 [2.0] 1 [2.0] Artery, Inflammation 1 [1.0] Artery, Mineralization 1 [2.0] Artery, Thrombosis 1 [2.0] ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (53) (54) (53) (53) (53) (53) Angiectasis 11 [1.5] 21 [1.9] 18 [1.6] 17 [1.8] 17 [1.6] 11 [1.7] Atrophy 2 [2.5] 4 [1.5] 5 [2.6] 5 [1.4] 27 [2.4] Degeneration, Cystic 11 [2.5] 15 [2.1] 21 [2.1] 18 [2.3] 17 [2.2] 17 [2.3] Hyperplasia 16 [2.0] 16 [2.2] 18 [2.4] 25 [2.3] 29 [2.3] 30 [2.5] Hypertrophy 41 [2.1] 43 [2.0] 46 [2.0] 40 [2.2] 45 [2.1] 47 [2.4] Inflammation, Chronic Active 1 [2.0] Inflammation, Suppurative 1 [1.0] Mineralization 1 [2.0] Necrosis 1 [3.0] 2 [1.5] 1 [3.0] 3 [2.7] 1 [3.0] 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 4 NTP Experiment-Test: 96007-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18 Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 09/30/03 Route: GAVAGE TOXIC EQUIVALENCY FACTOR EVALUATION (TCDD) Time: 09:06:07 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 0 NG/KG 3 NG/KG 10 NG/KG 22 NG/KG 46 NG/KG 100 NG/KG ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM - CONT Thrombosis 1 [2.0] Vacuolization Cytoplasmic 11 [1.4] 7 [1.3] 12 [1.3] 21 [1.6] 18 [1.7] 15 [2.1] Adrenal Medulla (53) (54) (53) (53) (53) (53) Angiectasis 1 [2.0] 2 [2.0] 1 [2.0] Hyperplasia 19 [1.8] 10 [2.0] 18 [2.0] 7 [1.6] 10 [2.4] 9 [1.9] Inflammation, Suppurative 1 [2.0] Islets, Pancreatic (51) (54) (53) (53) (52) (52) Hyperplasia 1 [4.0] 1 [4.0] Parathyroid Gland (46) (47) (47) (44) (45) (45) Fibrosis 1 [3.0] Hyperplasia 1 [2.0] Pituitary Gland (53) (54) (52) (53) (53) (52) Angiectasis 25 [2.3] 18 [2.6] 25 [2.3] 20 [2.1] 21 [1.9] 9 [2.1] Atypia Cellular 1 [2.0] Cyst 1 [2.0] 1 [3.0] 1 [2.0] Cytoplasmic Alteration 1 [1.0] 1 [1.0] 4 [1.5] 3 [2.0] Developmental Malformation 1 Inflammation, Chronic 1 [2.0] Vacuolization Cytoplasmic 3 [1.7] 1 [2.0] 2 [1.5] 2 [2.5] Pars Distalis, Hyperplasia 19 [2.1] 19 [2.1] 16 [2.3] 21 [2.1] 26 [2.4] 19 [1.7] Pars Intermedia, Hyperplasia 2 [2.5] 1 [2.0] 1 [3.0] Thyroid Gland (52) (54) (53) (51) (53) (52) Angiectasis 1 [2.0] 1 [1.0] 1 [2.0] 4 [2.0] 1 [1.0] Cyst 1 [3.0] 1 [2.0] 1 [2.0] Inflammation, Chronic Active 1 [2.0] Inflammation, Suppurative 1 [2.0] C-Cell, Hyperplasia 19 [1.8] 17 [2.2] 22 [2.1] 19 [2.3] 16 [1.9] 23 [1.9] Follicular Cell, Hyperplasia 2 [2.5] 2 [2.0] Follicular Cell, Hypertrophy 3 [2.3] 4 [1.5] 4 [2.0] 7 [1.1] 10 [1.2] 17 [1.2] ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Clitoral Gland (50) (52) (53) (52) (51) (53) Hyperplasia, Basal Cell 1 [2.0] 1 [2.0] Inflammation 41 [1.6] 40 [1.7] 35 [1.7] 34 [1.6] 28 [1.7] 26 [1.3] Duct, Cyst 34 [2.2] 37 [2.1] 41 [2.2] 42 [2.0] 41 [2.2] 48 [2.3] Ovary (51) (53) (53) (53) (53) (53) 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: 96007-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18 Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 09/30/03 Route: GAVAGE TOXIC EQUIVALENCY FACTOR EVALUATION (TCDD) Time: 09:06:07 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 0 NG/KG 3 NG/KG 10 NG/KG 22 NG/KG 46 NG/KG 100 NG/KG ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM - CONT Atrophy 49 [4.0] 46 [4.0] 50 [4.0] 44 [4.0] 50 [4.0] 31 [3.9] Congestion 1 [2.0] Cyst 14 [2.5] 16 [1.9] 13 [2.4] 15 [2.2] 14 [2.2] 13 [2.5] Fibrosis 1 [3.0] 1 [2.0] Inflammation, Chronic Active 1 [3.0] 1 [3.0] Inflammation, Suppurative 1 [4.0] 1 [2.0] Artery, Inflammation, Chronic Active 1 [3.0] Corpus Luteum, Cyst 1 [3.0] Periovarian Tissue, Inflammation, Suppurative 1 [2.0] Oviduct (2) (1) (2) (1) (1) Inflammation 2 [3.0] 1 [3.0] 1 [2.0] 1 [4.0] Necrosis 1 [4.0] Epithelium, Hyperplasia 1 [2.0] Uterus (52) (53) (53) (53) (53) (53) Adenomyosis 1 [2.0] Cyst 1 [3.0] Hemorrhage 1 [2.0] 1 [3.0] Inflammation, Chronic Active 2 [3.0] 3 [2.7] 3 [3.3] 1 [4.0] Inflammation, Suppurative 7 [1.9] 6 [1.8] 12 [2.4] 9 [2.1] 11 [2.3] 5 [2.2] Metaplasia, Squamous 29 [2.0] 31 [2.0] 28 [2.5] 23 [2.5] 32 [2.5] 17 [1.7] Necrosis 1 [4.0] Ulcer 1 [2.0] Cervix, Hyperplasia, Stromal 1 [4.0] 1 [4.0] 1 [4.0] 1 [4.0] Cervix, Inflammation, Suppurative 1 [3.0] Endometrium, Adenomyosis 1 [3.0] Endometrium, Hyperplasia, Cystic 30 [2.0] 33 [1.9] 35 [2.0] 27 [2.4] 31 [2.0] 19 [2.1] Epithelium, Hyperplasia 1 [3.0] Serosa, Inflammation, Chronic Active 1 [3.0] Vagina (1) (1) (3) (3) (1) Cyst 1 [2.0] 1 [2.0] Hyperplasia, Stromal 1 [3.0] Inflammation 2 [4.0] Necrosis 1 [4.0] ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (53) (54) (53) (53) (53) (53) Atrophy 1 [4.0] Hyperplasia 36 [3.0] 41 [3.2] 32 [3.2] 35 [3.1] 37 [2.9] 43 [2.8] Lymph Node (2) (6) (3) (5) (6) (9) Deep Cervical, Hemorrhage 1 [3.0] Inguinal, Ectasia 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 6 NTP Experiment-Test: 96007-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18 Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 09/30/03 Route: GAVAGE TOXIC EQUIVALENCY FACTOR EVALUATION (TCDD) Time: 09:06:07 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 0 NG/KG 3 NG/KG 10 NG/KG 22 NG/KG 46 NG/KG 100 NG/KG ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - CONT Lumbar, Ectasia 1 [3.0] 2 [2.0] 1 [3.0] 2 [2.0] Lumbar, Hemorrhage 1 [2.0] Lumbar, Hyperplasia, Plasma Cell 2 [3.0] 1 [3.0] Lumbar, Pigmentation 1 [3.0] Mediastinal, Congestion 1 [2.0] Mediastinal, Ectasia 1 [2.0] 3 [2.0] Mediastinal, Hemorrhage 1 [3.0] 1 [2.0] 5 [2.2] Mediastinal, Hyperplasia 1 [4.0] Mediastinal, Hyperplasia, Histiocytic 1 [2.0] 1 [2.0] 1 [2.0] Mediastinal, Hyperplasia, Lymphoid 1 [2.0] Mediastinal, Hyperplasia, Plasma Cell 1 [3.0] Mediastinal, Pigmentation 1 [2.0] 1 [2.0] Renal, Ectasia 1 [3.0] Renal, Hyperplasia, Histiocytic 1 [2.0] Lymph Node, Mandibular (51) (54) (52) (50) (51) (52) Congestion 1 [2.0] Ectasia 1 [2.0] 6 [2.7] Hyperplasia, Lymphoid 3 [2.0] 3 [2.0] 2 [2.0] Hyperplasia, Plasma Cell 25 [2.1] 31 [2.1] 23 [2.4] 22 [2.3] 15 [2.3] 16 [2.3] Inflammation, Suppurative 1 [2.0] Lymph Node, Mesenteric (52) (53) (53) (53) (53) (51) Atrophy 1 [3.0] 1 [2.0] Ectasia 1 [2.0] Hemorrhage 1 [3.0] Hyperplasia, Histiocytic 1 [2.0] 1 [3.0] 2 [2.5] Hyperplasia, Plasma Cell 1 [3.0] Spleen (51) (54) (53) (53) (52) (52) Hematopoietic Cell Proliferation 46 [1.5] 50 [1.6] 38 [1.3] 42 [1.6] 44 [1.5] 43 [1.5] Hyperplasia, Lymphoid 1 [2.0] 4 [2.0] Necrosis 1 [3.0] Pigmentation 45 [1.5] 49 [1.4] 49 [1.5] 51 [1.5] 49 [1.6] 47 [1.4] Lymphoid Follicle, Atrophy 4 [2.3] 1 [2.0] 1 [2.0] 1 [2.0] Thymus (51) (52) (52) (49) (46) (42) Atrophy 36 [2.6] 41 [2.7] 44 [3.0] 41 [3.1] 44 [3.6] 42 [3.9] Cyst 1 [3.0] 1 [2.0] Hemorrhage 1 [3.0] 1 [3.0] Inflammation, Chronic Active 1 [3.0] ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (53) (54) (53) (53) (53) (53) Cyst 4 [2.5] 3 [2.7] 1 [3.0] 1 [2.0] 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 7 NTP Experiment-Test: 96007-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18 Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 09/30/03 Route: GAVAGE TOXIC EQUIVALENCY FACTOR EVALUATION (TCDD) Time: 09:06:07 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 0 NG/KG 3 NG/KG 10 NG/KG 22 NG/KG 46 NG/KG 100 NG/KG ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM - CONT Hyperplasia 25 [1.4] 21 [1.4] 24 [1.5] 22 [1.4] 18 [1.2] 16 [1.5] Inflammation, Chronic Active 1 [3.0] Inflammation, Granulomatous 1 [2.0] 1 [2.0] 1 [2.0] 1 [3.0] Skin (53) (54) (53) (53) (53) (53) Cyst Epithelial Inclusion 1 2 Hemorrhage 1 [3.0] Hyperplasia, Squamous 1 [2.0] 1 [2.0] Inflammation, Chronic Active 2 [3.0] 1 [3.0] Necrosis 1 [3.0] Ulcer 1 [3.0] 1 [2.0] Epidermis, Inflammation 1 [2.0] ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (53) (54) (53) (53) (53) (53) Fracture 1 Maxilla, Inflammation, Focal, Suppurative 1 [2.0] Skeletal Muscle (1) (2) Hemorrhage 1 [3.0] Inflammation, Chronic Active 1 [3.0] ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (53) (54) (53) (53) (53) (53) Hemorrhage 1 [3.0] Hydrocephalus 1 [2.0] 1 [2.0] Inflammation, Suppurative 1 [3.0] Mineralization 1 [2.0] 1 [2.0] 2 [1.0] 2 [2.0] Vacuolization Cytoplasmic, Focal 1 [1.0] Artery, Thrombosis 1 [3.0] Cerebellum, Developmental Malformation 1 [3.0] Cerebellum, Necrosis 1 [3.0] Glial Cell, Hyperplasia 1 [2.0] 1 [2.0] Spinal Cord (1) Gliosis 1 [2.0] ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (53) (54) (53) (52) (53) (52) Congestion 2 [2.5] 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 8 NTP Experiment-Test: 96007-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18 Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 09/30/03 Route: GAVAGE TOXIC EQUIVALENCY FACTOR EVALUATION (TCDD) Time: 09:06:07 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 0 NG/KG 3 NG/KG 10 NG/KG 22 NG/KG 46 NG/KG 100 NG/KG ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM - CONT Edema 2 [2.0] 1 [2.0] Hemorrhage 1 [2.0] 2 [2.5] Infiltration Cellular, Histiocyte 41 [1.9] 46 [1.8] 43 [1.8] 43 [1.6] 49 [1.8] 50 [2.0] Inflammation, Chronic Active 1 [3.0] Inflammation, Granulomatous 2 [1.0] 1 [2.0] 2 [2.5] 2 [1.0] Inflammation, Suppurative 1 [3.0] 2 [1.5] Metaplasia, Squamous 1 [1.0] 5 [2.2] 6 [2.2] Mineralization 1 [2.0] 1 [1.0] 1 [2.0] Necrosis 1 [2.0] 1 [4.0] Pigmentation 1 [1.0] Alveolar Epithelium, Hyperplasia 12 [1.1] Alveolar Epithelium, Metaplasia, Bronchiolar 2 [1.0] 19 [1.6] 33 [1.5] 35 [1.4] 45 [1.7] 46 [2.0] Bronchiole, Dilatation 1 [2.0] Serosa, Inflammation, Focal, Suppurative 1 [2.0] Nose (53) (54) (53) (53) (53) (53) Cyst, Squamous 1 [3.0] Inflammation 2 [2.5] 3 [1.7] 5 [2.0] 4 [2.5] Goblet Cell, Septum, Hyperplasia 1 [2.0] Nasolacrimal Duct, Inflammation 2 [2.0] Nasolacrimal Duct, Respiratory Epithelium, Hyperplasia 1 [2.0] Nasopharyngeal Duct, Inflammation 1 [3.0] 1 [4.0] Nasopharyngeal Duct, Necrosis 1 [3.0] Olfactory Epithelium, Degeneration 1 [2.0] Olfactory Epithelium, Inflammation 1 [3.0] 1 [2.0] Respiratory Epithelium, Cyst 2 [2.0] Respiratory Epithelium, Hyperplasia 1 [3.0] 2 [2.0] Septum, Hyperplasia, Squamous 1 [2.0] Septum, Inflammation 2 [3.5] Squamous Epithelium, Inflammation, Suppurative 1 [1.0] Turbinate, Hyperplasia, Squamous 1 [2.0] Turbinate, Septum, Inflammation 1 [2.0] 1 [2.0] 2 [2.5] Turbinate, Respiratory Epithelium, Hyperplasia 1 [2.0] 1 [3.0] ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (53) (54) (53) (52) (53) (53) Degeneration 1 [4.0] Hemorrhage 1 [2.0] Anterior Chamber, Inflammation, Suppurative 1 [4.0] 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 9 NTP Experiment-Test: 96007-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18 Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 09/30/03 Route: GAVAGE TOXIC EQUIVALENCY FACTOR EVALUATION (TCDD) Time: 09:06:07 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 0 NG/KG 3 NG/KG 10 NG/KG 22 NG/KG 46 NG/KG 100 NG/KG ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM - CONT Cornea, Inflammation, Suppurative 1 [1.0] 1 [4.0] Lens, Degeneration 1 [4.0] Retina, Atrophy 5 [2.0] 5 [2.2] 5 [2.2] 3 [2.3] 4 [2.3] 6 [2.3] Retina, Degeneration 1 [3.0] Harderian Gland (53) (54) (53) (52) (53) (53) Atrophy, Focal 1 [2.0] Inflammation 12 [1.3] 3 [1.3] 2 [1.5] 2 [1.0] 8 [1.1] 6 [1.3] ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (53) (54) (53) (53) (53) (53) Calculus Gross Observation 1 [4.0] Calculus Micro Observation Only 1 [2.0] 1 [0.0] 1 [0.0] 3 [0.0] 2 [2.0] Casts Protein 3 [1.3] 5 [1.4] 2 [1.0] 1 [1.0] 1 [1.0] Cyst 2 [2.5] 1 [2.0] 1 [2.0] Fibrosis 1 [2.0] Infarct 1 [3.0] Inflammation, Chronic Active 5 [1.2] 1 [1.0] 1 [2.0] 1 [2.0] Inflammation, Suppurative 2 [2.0] 1 [3.0] 1 [3.0] 2 [3.0] Mineralization 40 [1.1] 39 [1.1] 30 [1.0] 32 [1.0] 42 [1.1] 42 [1.1] Necrosis 1 [3.0] 1 [2.0] Nephropathy 34 [1.2] 26 [1.1] 32 [1.3] 36 [1.4] 39 [1.4] 52 [2.2] Papilla, Necrosis 1 [3.0] Pelvis, Dilatation 2 [3.0] 1 [2.0] 1 [3.0] 2 [3.0] Pelvis, Inflammation 2 [3.0] 1 [2.0] 1 [2.0] 1 [1.0] 4 [2.3] 2 [3.0] Renal Tubule, Degeneration 1 [2.0] Transitional Epithelium, Hyperplasia 3 [2.3] 6 [1.7] 8 [1.8] 8 [1.3] 11 [2.0] 11 [1.8] Ureter (1) Inflammation 1 [2.0] Transitional Epithelium, Hyperplasia 1 [3.0] Urinary Bladder (52) (53) (53) (52) (53) (53) Calculus Micro Observation Only 1 Hemorrhage 1 [3.0] Inflammation 6 [1.5] 10 [1.3] 4 [1.5] 8 [2.0] 3 [1.7] Metaplasia, Squamous 1 [3.0] Transitional Epithelium, Hyperplasia 1 [2.0] 2 [2.0] 1 [2.0] 6 [2.2] 2 [2.5] 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 10 NTP Experiment-Test: 96007-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18 Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 09/30/03 Route: GAVAGE TOXIC EQUIVALENCY FACTOR EVALUATION (TCDD) Time: 09:06:07 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 100 NG/ KG/STOP ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 50 Early Deaths Moribund Sacrifice 16 Natural Death 13 Survivors Terminal Sacrifice 21 Animals Examined Microscopically 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Colon (49) Parasite Metazoan 1 [1.0] Intestine Large, Rectum (50) Parasite Metazoan 5 Intestine Small, Jejunum (50) Inflammation, Chronic 1 [2.0] Liver (50) Angiectasis 4 [1.5] Atypia Cellular 1 [1.0] Basophilic Focus 7 Basophilic Focus, Multiple 9 Cholangiofibrosis 1 [2.0] Clear Cell Focus 6 Clear Cell Focus, Multiple 2 Cytoplasmic Alteration 1 [1.0] Eosinophilic Focus 6 Eosinophilic Focus, Multiple 21 Fatty Change, Diffuse 10 [1.4] Fatty Change, Focal 8 [1.3] Hematopoietic Cell Proliferation 2 [2.5] Hepatodiaphragmatic Nodule 1 Inflammation 43 [1.2] Mixed Cell Focus 1 Mixed Cell Focus, Multiple 28 Necrosis 8 [1.8] Pigmentation 45 [1.8] Toxic Hepatopathy 16 [1.3] Vacuolization Cytoplasmic 1 [1.0] Bile Duct, Cyst 6 [2.3] Bile Duct, Fibrosis 5 [1.2] 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 11 NTP Experiment-Test: 96007-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18 Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 09/30/03 Route: GAVAGE TOXIC EQUIVALENCY FACTOR EVALUATION (TCDD) Time: 09:06:07 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 100 NG/ KG/STOP ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Bile Duct, Hyperplasia 7 [1.3] Hepatocyte, Hypertrophy 22 [1.7] Hepatocyte, Multinucleated 32 [1.3] Oval Cell, Hyperplasia 1 [1.0] Portal, Fibrosis 1 [2.0] Serosa, Inflammation, Chronic Active 1 [3.0] Mesentery (1) Artery, Inflammation, Chronic Active 1 [3.0] Oral Mucosa (11) Gingival, Hyperplasia, Squamous 8 [1.9] Pancreas (49) Angiectasis 1 [2.0] Basophilic Focus 1 [1.0] Inflammation, Chronic Active 4 [1.5] Acinus, Atrophy 4 [1.8] Artery, Inflammation, Chronic Active 2 [2.5] Salivary Glands (49) Atrophy 2 [2.0] Fibrosis 1 [2.0] Inflammation 1 [1.0] Stomach, Forestomach (50) Hyperkeratosis 1 [2.0] Hyperplasia, Squamous 5 [1.8] Inflammation 4 [2.0] Ulcer 4 [2.3] Stomach, Glandular (50) Erosion 1 [2.0] Tongue (1) Inflammation, Chronic Active 1 [3.0] Tooth (12) Peridontal Tissue, Inflammation 12 [1.6] ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (50) Cardiomyopathy 22 [1.4] Inflammation 1 [2.0] Atrium, Thrombosis 2 [3.0] Epicardium, Inflammation, Chronic Active 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 12 NTP Experiment-Test: 96007-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18 Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 09/30/03 Route: GAVAGE TOXIC EQUIVALENCY FACTOR EVALUATION (TCDD) Time: 09:06:07 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 100 NG/ KG/STOP ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (50) Angiectasis 15 [1.9] Atrophy 4 [1.8] Degeneration, Cystic 17 [2.2] Hyperplasia 20 [2.6] Hypertrophy 46 [2.1] Necrosis 3 [3.0] Vacuolization Cytoplasmic 13 [1.3] Adrenal Medulla (50) Hyperplasia 15 [2.1] Islets, Pancreatic (49) Hyperplasia 1 [2.0] Pituitary Gland (50) Angiectasis 15 [2.1] Cytoplasmic Alteration 1 [2.0] Vacuolization Cytoplasmic 3 [1.7] Pars Distalis, Hyperplasia 18 [1.8] Thyroid Gland (49) Angiectasis 1 [2.0] C-Cell, Hyperplasia 15 [1.9] Follicular Cell, Hypertrophy 6 [1.5] ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Clitoral Gland (49) Atrophy 1 [2.0] Hyperplasia, Basal Cell 1 [1.0] Hyperplasia, Squamous 1 [3.0] Inflammation 35 [1.5] Duct, Cyst 35 [2.0] Ovary (49) Atrophy 45 [4.0] Cyst 16 [2.3] Inflammation, Granulomatous 1 [3.0] Oviduct (2) Inflammation 2 [3.0] 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 13 NTP Experiment-Test: 96007-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18 Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 09/30/03 Route: GAVAGE TOXIC EQUIVALENCY FACTOR EVALUATION (TCDD) Time: 09:06:07 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 100 NG/ KG/STOP ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM - CONT Uterus (50) Inflammation, Chronic Active 1 [3.0] Inflammation, Suppurative 9 [2.7] Metaplasia, Squamous 33 [2.1] Cervix, Inflammation, Chronic Active 1 [3.0] Endometrium, Hyperplasia, Cystic 32 [2.1] ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (50) Atrophy 1 [2.0] Hyperplasia 36 [2.9] Myelofibrosis 1 [2.0] Lymph Node (5) Lumbar, Ectasia 2 [2.5] Lumbar, Hyperplasia, Plasma Cell 2 [2.5] Mediastinal, Hemorrhage 1 [2.0] Mediastinal, Hyperplasia, Plasma Cell 1 [2.0] Lymph Node, Mandibular (49) Ectasia 2 [2.0] Hyperplasia, Lymphoid 2 [2.5] Hyperplasia, Plasma Cell 30 [2.2] Lymph Node, Mesenteric (49) Hyperplasia, Histiocytic 1 [3.0] Spleen (49) Hematopoietic Cell Proliferation 42 [1.5] Hyperplasia, Lymphoid 1 [2.0] Pigmentation 42 [1.6] Lymphoid Follicle, Atrophy 1 [2.0] Red Pulp, Atrophy 1 [2.0] Thymus (49) Atrophy 45 [3.3] ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (50) Cyst 4 [2.3] Hyperplasia 19 [1.2] Skin (50) Ulcer 1 [3.0] ____________________________________________________________________________________________________________________________________ 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 14 NTP Experiment-Test: 96007-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18 Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 09/30/03 Route: GAVAGE TOXIC EQUIVALENCY FACTOR EVALUATION (TCDD) Time: 09:06:07 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 100 NG/ KG/STOP ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM None ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) Hemorrhage 1 [3.0] Inflammation, Suppurative 1 [2.0] ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) Infiltration Cellular, Histiocyte 41 [2.0] Inflammation, Suppurative 1 [3.0] Metaplasia, Squamous 3 [1.3] Alveolar Epithelium, Metaplasia, Bronchiolar 31 [1.3] Serosa, Inflammation, Suppurative 1 [3.0] Nose (50) Inflammation 1 [1.0] Goblet Cell, Respiratory Epithelium, Hyperplasia 1 [3.0] Nasolacrimal Duct, Inflammation 1 [3.0] Olfactory Epithelium, Degeneration 1 [3.0] Olfactory Epithelium, Inflammation 1 [3.0] Olfactory Epithelium, Glands, Hyperplasia 1 [2.0] Respiratory Epithelium, Cyst 1 [2.0] Respiratory Epithelium, Inflammation, Suppurative 1 [4.0] ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (50) Retinal Detachment 1 [3.0] Bilateral, Cataract 1 [3.0] Retina, Atrophy 6 [1.8] Retina, Degeneration 1 [3.0] Harderian Gland (50) Hemorrhage 1 [2.0] Inflammation 9 [1.1] 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 15 NTP Experiment-Test: 96007-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18 Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 09/30/03 Route: GAVAGE TOXIC EQUIVALENCY FACTOR EVALUATION (TCDD) Time: 09:06:07 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 100 NG/ KG/STOP ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) Accumulation, Hyaline Droplet 2 [2.5] Casts Protein 1 [1.0] Mineralization 42 [1.0] Nephropathy 41 [1.4] Papilla, Transitional Epithelium, Hyperplasia 1 [1.0] Pelvis, Dilatation 1 [2.0] Transitional Epithelium, Hyperplasia 5 [1.4] Urinary Bladder (50) Inflammation 2 [1.0] 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 16 ------------------------------------------------------------ ---------- END OF REPORT ---------- ------------------------------------------------------------