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
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