TDMS Study 96007-03 Pathology Tables
NTP Experiment-Test: 96007-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION (TCDD) Date: 09/30/03
Route: GAVAGE Time: 08:37:05
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
Page 1
NTP Experiment-Test: 96007-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION (TCDD) Date: 09/30/03
Route: GAVAGE Time: 08:37:05
____________________________________________________________________________________________________________________________________
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 (2%)
Perforation 2 (4%)
Muscularis, Inflammation 1 (2%) 2 (4%) 1 (2%) 1 (2%) 2 (4%)
Periesophageal Tissue, Inflammation 3 (6%)
Intestine Large, Colon (52) (53) (53) (53) (53) (51)
Parasite Metazoan 1 (2%) 2 (4%) 1 (2%) 2 (4%)
Intestine Large, Rectum (52) (54) (53) (52) (53) (53)
Parasite Metazoan 6 (12%) 4 (7%) 2 (4%) 1 (2%)
Intestine Small, Duodenum (53) (54) (53) (52) (53) (53)
Cyst 1 (2%)
Ulcer 1 (2%)
Epithelium, Hyperplasia 1 (2%)
Liver (53) (54) (53) (53) (53) (53)
Angiectasis 2 (4%) 1 (2%) 1 (2%) 3 (6%) 5 (9%)
Basophilic Focus 8 (15%) 6 (11%) 8 (15%) 7 (13%) 3 (6%) 3 (6%)
Basophilic Focus, Multiple 4 (8%) 3 (6%) 5 (9%) 1 (2%) 2 (4%) 5 (9%)
Cholangiofibrosis 1 (2%) 1 (2%) 2 (4%) 1 (2%) 11 (21%) 31 (58%)
Clear Cell Focus 4 (8%) 1 (2%) 1 (2%) 2 (4%) 1 (2%) 1 (2%)
Clear Cell Focus, Multiple 1 (2%) 2 (4%) 1 (2%) 1 (2%)
Congestion 2 (4%) 2 (4%)
Cytoplasmic Alteration 2 (4%)
Degeneration, Cystic 2 (4%) 4 (8%)
Eosinophilic Focus 8 (15%) 6 (11%) 7 (13%) 10 (19%) 5 (9%) 2 (4%)
Eosinophilic Focus, Multiple 3 (6%) 8 (15%) 14 (26%) 17 (32%) 22 (42%) 42 (79%)
Fatty Change, Diffuse 2 (4%) 12 (23%) 17 (32%) 30 (57%) 48 (91%)
Fatty Change, Focal 2 (4%) 6 (11%) 4 (8%) 4 (8%) 1 (2%) 2 (4%)
Hematopoietic Cell Proliferation 1 (2%) 2 (4%) 2 (4%) 4 (8%) 2 (4%) 2 (4%)
Hemorrhage 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 2
NTP Experiment-Test: 96007-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION (TCDD) Date: 09/30/03
Route: GAVAGE Time: 08:37:05
____________________________________________________________________________________________________________________________________
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 (4%) 1 (2%) 2 (4%)
Hyperplasia, Nodular 3 (6%) 7 (13%) 36 (68%)
Inflammation 33 (62%) 46 (85%) 47 (89%) 50 (94%) 52 (98%) 49 (92%)
Mitotic Alteration 1 (2%) 1 (2%)
Mixed Cell Focus 4 (8%) 8 (15%) 8 (15%) 2 (4%) 4 (8%)
Mixed Cell Focus, Multiple 26 (49%) 11 (20%) 21 (40%) 23 (43%) 28 (53%) 17 (32%)
Necrosis 1 (2%) 4 (7%) 4 (8%) 8 (15%) 10 (19%) 17 (32%)
Pigmentation 4 (8%) 9 (17%) 34 (64%) 48 (91%) 52 (98%) 53 (100%)
Thrombosis 1 (2%)
Toxic Hepatopathy 2 (4%) 8 (15%) 30 (57%) 45 (85%) 53 (100%)
Artery, Inflammation, Chronic Active 2 (4%)
Bile Duct, Cyst 3 (6%) 1 (2%) 2 (4%) 2 (4%) 21 (40%)
Bile Duct, Fibrosis 2 (4%) 1 (2%) 3 (6%) 4 (8%)
Bile Duct, Hyperplasia 5 (9%) 4 (7%) 7 (13%) 22 (42%) 40 (75%) 53 (100%)
Centrilobular, Degeneration 2 (4%) 2 (4%) 4 (8%) 3 (6%) 5 (9%)
Hepatocyte, Hypertrophy 19 (35%) 19 (36%) 42 (79%) 41 (77%) 52 (98%)
Hepatocyte, Multinucleated 16 (30%) 26 (49%) 36 (68%) 51 (96%)
Hepatocyte, Centrilobular, Atrophy 1 (2%)
Oval Cell, Hyperplasia 4 (7%) 3 (6%) 20 (38%) 38 (72%) 53 (100%)
Portal, Fibrosis 5 (9%) 27 (51%)
Mesentery (2) (2) (1) (6) (8)
Metaplasia, Osseous 1 (50%)
Artery, Inflammation, Chronic Active 1 (50%) 4 (67%) 7 (88%)
Fat, Necrosis 1 (50%) 1 (100%) 1 (17%) 1 (13%)
Vein, Thrombosis 1 (50%)
Oral Mucosa (2) (9) (16) (16) (22) (29)
Gingival, Hyperplasia, Squamous 1 (50%) 7 (78%) 14 (88%) 13 (81%) 15 (68%) 16 (55%)
Pancreas (51) (54) (52) (53) (52) (51)
Hemorrhage 1 (2%)
Inflammation, Acute 1 (2%)
Inflammation, Chronic Active 2 (4%) 2 (4%) 3 (6%) 6 (12%)
Necrosis 1 (2%) 1 (2%)
Acinus, Atrophy 1 (2%) 2 (4%) 4 (8%) 4 (8%) 4 (8%) 9 (18%)
Acinus, Hyperplasia 2 (4%) 1 (2%) 2 (4%)
Acinus, Vacuolization Cytoplasmic 1 (2%) 1 (2%) 15 (29%) 42 (82%)
Artery, Inflammation, Chronic Active 1 (2%) 1 (2%) 2 (4%) 2 (4%) 7 (14%)
Salivary Glands (51) (54) (52) (50) (51) (52)
Atrophy 2 (4%) 1 (2%)
Inflammation 2 (4%) 3 (6%) 1 (2%)
Mineralization 1 (2%)
Stomach, Forestomach (53) (54) (53) (53) (53) (53)
Cyst, Squamous 1 (2%)
Edema 1 (2%) 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 3
NTP Experiment-Test: 96007-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION (TCDD) Date: 09/30/03
Route: GAVAGE Time: 08:37:05
____________________________________________________________________________________________________________________________________
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%) 1 (2%)
Hyperkeratosis 1 (2%) 1 (2%) 1 (2%) 1 (2%) 2 (4%) 3 (6%)
Hyperplasia, Squamous 3 (6%) 4 (7%) 4 (8%) 2 (4%) 7 (13%) 11 (21%)
Inflammation 1 (2%) 1 (2%) 2 (4%) 2 (4%) 5 (9%)
Mineralization 1 (2%)
Necrosis 1 (2%)
Ulcer 2 (4%) 1 (2%) 1 (2%) 1 (2%) 4 (8%)
Stomach, Glandular (53) (54) (53) (53) (53) (53)
Diverticulum 1 (2%)
Erosion 1 (2%)
Metaplasia 1 (2%)
Mineralization 3 (6%) 1 (2%) 3 (6%)
Ulcer 2 (4%)
Tooth (16) (16) (12) (13) (14) (18)
Peridontal Tissue, Fibrosis 1 (6%)
Peridontal Tissue, Inflammation 15 (94%) 16 (100%) 12 (100%) 13 (100%) 14 (100%) 18 (100%)
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CARDIOVASCULAR SYSTEM
Blood Vessel (53) (54) (53) (53) (53) (53)
Thrombosis 1 (2%)
Aorta, Mineralization 1 (2%) 1 (2%) 1 (2%)
Heart (53) (54) (53) (52) (53) (52)
Cardiomyopathy 10 (19%) 12 (22%) 22 (42%) 25 (48%) 32 (60%) 36 (69%)
Mineralization 1 (2%) 1 (2%)
Artery, Inflammation 1 (2%)
Artery, Mineralization 1 (2%)
Artery, Thrombosis 1 (2%)
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ENDOCRINE SYSTEM
Adrenal Cortex (53) (54) (53) (53) (53) (53)
Angiectasis 11 (21%) 21 (39%) 18 (34%) 17 (32%) 17 (32%) 11 (21%)
Atrophy 2 (4%) 4 (8%) 5 (9%) 5 (9%) 27 (51%)
Degeneration, Cystic 11 (21%) 15 (28%) 21 (40%) 18 (34%) 17 (32%) 17 (32%)
Hyperplasia 16 (30%) 16 (30%) 18 (34%) 25 (47%) 29 (55%) 30 (57%)
Hypertrophy 41 (77%) 43 (80%) 46 (87%) 40 (75%) 45 (85%) 47 (89%)
Inflammation, Chronic Active 1 (2%)
Inflammation, Suppurative 1 (2%)
Mineralization 1 (2%)
Necrosis 1 (2%) 2 (4%) 1 (2%) 3 (6%) 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 4
NTP Experiment-Test: 96007-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION (TCDD) Date: 09/30/03
Route: GAVAGE Time: 08:37:05
____________________________________________________________________________________________________________________________________
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%)
Vacuolization Cytoplasmic 11 (21%) 7 (13%) 12 (23%) 21 (40%) 18 (34%) 15 (28%)
Adrenal Medulla (53) (54) (53) (53) (53) (53)
Angiectasis 1 (2%) 2 (4%) 1 (2%)
Hyperplasia 19 (36%) 10 (19%) 18 (34%) 7 (13%) 10 (19%) 9 (17%)
Inflammation, Suppurative 1 (2%)
Islets, Pancreatic (51) (54) (53) (53) (52) (52)
Hyperplasia 1 (2%) 1 (2%)
Parathyroid Gland (46) (47) (47) (44) (45) (45)
Fibrosis 1 (2%)
Hyperplasia 1 (2%)
Pituitary Gland (53) (54) (52) (53) (53) (52)
Angiectasis 25 (47%) 18 (33%) 25 (48%) 20 (38%) 21 (40%) 9 (17%)
Atypia Cellular 1 (2%)
Cyst 1 (2%) 1 (2%) 1 (2%)
Cytoplasmic Alteration 1 (2%) 1 (2%) 4 (8%) 3 (6%)
Developmental Malformation 1 (2%)
Inflammation, Chronic 1 (2%)
Vacuolization Cytoplasmic 3 (6%) 1 (2%) 2 (4%) 2 (4%)
Pars Distalis, Hyperplasia 19 (36%) 19 (35%) 16 (31%) 21 (40%) 26 (49%) 19 (37%)
Pars Intermedia, Hyperplasia 2 (4%) 1 (2%) 1 (2%)
Thyroid Gland (52) (54) (53) (51) (53) (52)
Angiectasis 1 (2%) 1 (2%) 1 (2%) 4 (8%) 1 (2%)
Cyst 1 (2%) 1 (2%) 1 (2%)
Inflammation, Chronic Active 1 (2%)
Inflammation, Suppurative 1 (2%)
C-Cell, Hyperplasia 19 (37%) 17 (31%) 22 (42%) 19 (37%) 16 (30%) 23 (44%)
Follicular Cell, Hyperplasia 2 (4%) 2 (4%)
Follicular Cell, Hypertrophy 3 (6%) 4 (7%) 4 (8%) 7 (14%) 10 (19%) 17 (33%)
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GENERAL BODY SYSTEM
None
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GENITAL SYSTEM
Clitoral Gland (50) (52) (53) (52) (51) (53)
Hyperplasia, Basal Cell 1 (2%) 1 (2%)
Inflammation 41 (82%) 40 (77%) 35 (66%) 34 (65%) 28 (55%) 26 (49%)
Duct, Cyst 34 (68%) 37 (71%) 41 (77%) 42 (81%) 41 (80%) 48 (91%)
Ovary (51) (53) (53) (53) (53) (53)
a Number of animals examined microscopically at site and number of animals with lesion
Page 5
NTP Experiment-Test: 96007-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION (TCDD) Date: 09/30/03
Route: GAVAGE Time: 08:37:05
____________________________________________________________________________________________________________________________________
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 (96%) 46 (87%) 50 (94%) 44 (83%) 50 (94%) 31 (58%)
Congestion 1 (2%)
Cyst 14 (27%) 16 (30%) 13 (25%) 15 (28%) 14 (26%) 13 (25%)
Fibrosis 1 (2%) 1 (2%)
Inflammation, Chronic Active 1 (2%) 1 (2%)
Inflammation, Suppurative 1 (2%) 1 (2%)
Artery, Inflammation, Chronic Active 1 (2%)
Corpus Luteum, Cyst 1 (2%)
Periovarian Tissue, Inflammation, Suppurative 1 (2%)
Oviduct (2) (1) (2) (1) (1)
Inflammation 2 (100%) 1 (100%) 1 (50%) 1 (100%)
Necrosis 1 (100%)
Epithelium, Hyperplasia 1 (50%)
Uterus (52) (53) (53) (53) (53) (53)
Adenomyosis 1 (2%)
Cyst 1 (2%)
Hemorrhage 1 (2%) 1 (2%)
Inflammation, Chronic Active 2 (4%) 3 (6%) 3 (6%) 1 (2%)
Inflammation, Suppurative 7 (13%) 6 (11%) 12 (23%) 9 (17%) 11 (21%) 5 (9%)
Metaplasia, Squamous 29 (56%) 31 (58%) 28 (53%) 23 (43%) 32 (60%) 17 (32%)
Necrosis 1 (2%)
Ulcer 1 (2%)
Cervix, Hyperplasia, Stromal 1 (2%) 1 (2%) 1 (2%) 1 (2%)
Cervix, Inflammation, Suppurative 1 (2%)
Endometrium, Adenomyosis 1 (2%)
Endometrium, Hyperplasia, Cystic 30 (58%) 33 (62%) 35 (66%) 27 (51%) 31 (58%) 19 (36%)
Epithelium, Hyperplasia 1 (2%)
Serosa, Inflammation, Chronic Active 1 (2%)
Vagina (1) (1) (3) (3) (1)
Cyst 1 (100%) 1 (33%)
Hyperplasia, Stromal 1 (100%)
Inflammation 2 (67%)
Necrosis 1 (33%)
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HEMATOPOIETIC SYSTEM
Bone Marrow (53) (54) (53) (53) (53) (53)
Atrophy 1 (2%)
Hyperplasia 36 (68%) 41 (76%) 32 (60%) 35 (66%) 37 (70%) 43 (81%)
Lymph Node (2) (6) (3) (5) (6) (9)
Deep Cervical, Hemorrhage 1 (20%)
Inguinal, Ectasia 1 (17%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 6
NTP Experiment-Test: 96007-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION (TCDD) Date: 09/30/03
Route: GAVAGE Time: 08:37:05
____________________________________________________________________________________________________________________________________
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 (50%) 2 (33%) 1 (33%) 2 (40%)
Lumbar, Hemorrhage 1 (20%)
Lumbar, Hyperplasia, Plasma Cell 2 (33%) 1 (20%)
Lumbar, Pigmentation 1 (20%)
Mediastinal, Congestion 1 (17%)
Mediastinal, Ectasia 1 (17%) 3 (33%)
Mediastinal, Hemorrhage 1 (17%) 1 (20%) 5 (56%)
Mediastinal, Hyperplasia 1 (17%)
Mediastinal, Hyperplasia, Histiocytic 1 (33%) 1 (17%) 1 (11%)
Mediastinal, Hyperplasia, Lymphoid 1 (17%)
Mediastinal, Hyperplasia, Plasma Cell 1 (20%)
Mediastinal, Pigmentation 1 (33%) 1 (11%)
Renal, Ectasia 1 (17%)
Renal, Hyperplasia, Histiocytic 1 (17%)
Lymph Node, Mandibular (51) (54) (52) (50) (51) (52)
Congestion 1 (2%)
Ectasia 1 (2%) 6 (12%)
Hyperplasia, Lymphoid 3 (6%) 3 (6%) 2 (4%)
Hyperplasia, Plasma Cell 25 (49%) 31 (57%) 23 (44%) 22 (44%) 15 (29%) 16 (31%)
Inflammation, Suppurative 1 (2%)
Lymph Node, Mesenteric (52) (53) (53) (53) (53) (51)
Atrophy 1 (2%) 1 (2%)
Ectasia 1 (2%)
Hemorrhage 1 (2%)
Hyperplasia, Histiocytic 1 (2%) 1 (2%) 2 (4%)
Hyperplasia, Plasma Cell 1 (2%)
Spleen (51) (54) (53) (53) (52) (52)
Hematopoietic Cell Proliferation 46 (90%) 50 (93%) 38 (72%) 42 (79%) 44 (85%) 43 (83%)
Hyperplasia, Lymphoid 1 (2%) 4 (8%)
Necrosis 1 (2%)
Pigmentation 45 (88%) 49 (91%) 49 (92%) 51 (96%) 49 (94%) 47 (90%)
Lymphoid Follicle, Atrophy 4 (8%) 1 (2%) 1 (2%) 1 (2%)
Thymus (51) (52) (52) (49) (46) (42)
Atrophy 36 (71%) 41 (79%) 44 (85%) 41 (84%) 44 (96%) 42 (100%)
Cyst 1 (2%) 1 (2%)
Hemorrhage 1 (2%) 1 (2%)
Inflammation, Chronic Active 1 (2%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (53) (54) (53) (53) (53) (53)
Cyst 4 (8%) 3 (6%) 1 (2%) 1 (2%) 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 7
NTP Experiment-Test: 96007-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION (TCDD) Date: 09/30/03
Route: GAVAGE Time: 08:37:05
____________________________________________________________________________________________________________________________________
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 (47%) 21 (39%) 24 (45%) 22 (42%) 18 (34%) 16 (30%)
Inflammation, Chronic Active 1 (2%)
Inflammation, Granulomatous 1 (2%) 1 (2%) 1 (2%) 1 (2%)
Skin (53) (54) (53) (53) (53) (53)
Cyst Epithelial Inclusion 1 (2%) 2 (4%)
Hemorrhage 1 (2%)
Hyperplasia, Squamous 1 (2%) 1 (2%)
Inflammation, Chronic Active 2 (4%) 1 (2%)
Necrosis 1 (2%)
Ulcer 1 (2%) 1 (2%)
Epidermis, Inflammation 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (53) (54) (53) (53) (53) (53)
Fracture 1 (2%)
Maxilla, Inflammation, Focal, Suppurative 1 (2%)
Skeletal Muscle (1) (2)
Hemorrhage 1 (50%)
Inflammation, Chronic Active 1 (50%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (53) (54) (53) (53) (53) (53)
Hemorrhage 1 (2%)
Hydrocephalus 1 (2%) 1 (2%)
Inflammation, Suppurative 1 (2%)
Mineralization 1 (2%) 1 (2%) 2 (4%) 2 (4%)
Vacuolization Cytoplasmic, Focal 1 (2%)
Artery, Thrombosis 1 (2%)
Cerebellum, Developmental Malformation 1 (2%)
Cerebellum, Necrosis 1 (2%)
Glial Cell, Hyperplasia 1 (2%) 1 (2%)
Spinal Cord (1)
Gliosis 1 (100%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (53) (54) (53) (52) (53) (52)
Congestion 2 (4%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 8
NTP Experiment-Test: 96007-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION (TCDD) Date: 09/30/03
Route: GAVAGE Time: 08:37:05
____________________________________________________________________________________________________________________________________
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 (4%) 1 (2%)
Hemorrhage 1 (2%) 2 (4%)
Infiltration Cellular, Histiocyte 41 (77%) 46 (85%) 43 (81%) 43 (83%) 49 (92%) 50 (96%)
Inflammation, Chronic Active 1 (2%)
Inflammation, Granulomatous 2 (4%) 1 (2%) 2 (4%) 2 (4%)
Inflammation, Suppurative 1 (2%) 2 (4%)
Metaplasia, Squamous 1 (2%) 5 (9%) 6 (12%)
Mineralization 1 (2%) 1 (2%) 1 (2%)
Necrosis 1 (2%) 1 (2%)
Pigmentation 1 (2%)
Alveolar Epithelium, Hyperplasia 12 (23%)
Alveolar Epithelium, Metaplasia, Bronchiolar 2 (4%) 19 (35%) 33 (62%) 35 (67%) 45 (85%) 46 (88%)
Bronchiole, Dilatation 1 (2%)
Serosa, Inflammation, Focal, Suppurative 1 (2%)
Nose (53) (54) (53) (53) (53) (53)
Cyst, Squamous 1 (2%)
Inflammation 2 (4%) 3 (6%) 5 (9%) 4 (8%)
Goblet Cell, Septum, Hyperplasia 1 (2%)
Nasolacrimal Duct, Inflammation 2 (4%)
Nasolacrimal Duct, Respiratory Epithelium,
Hyperplasia 1 (2%)
Nasopharyngeal Duct, Inflammation 1 (2%) 1 (2%)
Nasopharyngeal Duct, Necrosis 1 (2%)
Olfactory Epithelium, Degeneration 1 (2%)
Olfactory Epithelium, Inflammation 1 (2%) 1 (2%)
Respiratory Epithelium, Cyst 2 (4%)
Respiratory Epithelium, Hyperplasia 1 (2%) 2 (4%)
Septum, Hyperplasia, Squamous 1 (2%)
Septum, Inflammation 2 (4%)
Squamous Epithelium, Inflammation,
Suppurative 1 (2%)
Turbinate, Hyperplasia, Squamous 1 (2%)
Turbinate, Septum, Inflammation 1 (2%) 1 (2%) 2 (4%)
Turbinate, Respiratory Epithelium,
Hyperplasia 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (53) (54) (53) (52) (53) (53)
Degeneration 1 (2%)
Hemorrhage 1 (2%)
Anterior Chamber, Inflammation, Suppurative 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 9
NTP Experiment-Test: 96007-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION (TCDD) Date: 09/30/03
Route: GAVAGE Time: 08:37:05
____________________________________________________________________________________________________________________________________
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 (2%) 1 (2%)
Lens, Degeneration 1 (2%)
Retina, Atrophy 5 (9%) 5 (9%) 5 (9%) 3 (6%) 4 (8%) 6 (11%)
Retina, Degeneration 1 (2%)
Harderian Gland (53) (54) (53) (52) (53) (53)
Atrophy, Focal 1 (2%)
Inflammation 12 (23%) 3 (6%) 2 (4%) 2 (4%) 8 (15%) 6 (11%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (53) (54) (53) (53) (53) (53)
Calculus Gross Observation 1 (2%)
Calculus Micro Observation Only 1 (2%) 1 (2%) 1 (2%) 3 (6%) 2 (4%)
Casts Protein 3 (6%) 5 (9%) 2 (4%) 1 (2%) 1 (2%)
Cyst 2 (4%) 1 (2%) 1 (2%)
Fibrosis 1 (2%)
Infarct 1 (2%)
Inflammation, Chronic Active 5 (9%) 1 (2%) 1 (2%) 1 (2%)
Inflammation, Suppurative 2 (4%) 1 (2%) 1 (2%) 2 (4%)
Mineralization 40 (75%) 39 (72%) 30 (57%) 32 (60%) 42 (79%) 42 (79%)
Necrosis 1 (2%) 1 (2%)
Nephropathy 34 (64%) 26 (48%) 32 (60%) 36 (68%) 39 (74%) 52 (98%)
Papilla, Necrosis 1 (2%)
Pelvis, Dilatation 2 (4%) 1 (2%) 1 (2%) 2 (4%)
Pelvis, Inflammation 2 (4%) 1 (2%) 1 (2%) 1 (2%) 4 (8%) 2 (4%)
Renal Tubule, Degeneration 1 (2%)
Transitional Epithelium, Hyperplasia 3 (6%) 6 (11%) 8 (15%) 8 (15%) 11 (21%) 11 (21%)
Ureter (1)
Inflammation 1 (100%)
Transitional Epithelium, Hyperplasia 1 (100%)
Urinary Bladder (52) (53) (53) (52) (53) (53)
Calculus Micro Observation Only 1 (2%)
Hemorrhage 1 (2%)
Inflammation 6 (12%) 10 (19%) 4 (8%) 8 (15%) 3 (6%)
Metaplasia, Squamous 1 (2%)
Transitional Epithelium, Hyperplasia 1 (2%) 2 (4%) 1 (2%) 6 (11%) 2 (4%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 10
NTP Experiment-Test: 96007-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION (TCDD) Date: 09/30/03
Route: GAVAGE Time: 08:37:05
____________________________________________________________________________________________________________________________________
SPRAGUE-DAWLEY RATS FEMALE 100 NG/
KG/STOP
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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 (2%)
Intestine Large, Rectum (50)
Parasite Metazoan 5 (10%)
Intestine Small, Jejunum (50)
Inflammation, Chronic 1 (2%)
Liver (50)
Angiectasis 4 (8%)
Atypia Cellular 1 (2%)
Basophilic Focus 7 (14%)
Basophilic Focus, Multiple 9 (18%)
Cholangiofibrosis 1 (2%)
Clear Cell Focus 6 (12%)
Clear Cell Focus, Multiple 2 (4%)
Cytoplasmic Alteration 1 (2%)
Eosinophilic Focus 6 (12%)
Eosinophilic Focus, Multiple 21 (42%)
Fatty Change, Diffuse 10 (20%)
Fatty Change, Focal 8 (16%)
Hematopoietic Cell Proliferation 2 (4%)
Hepatodiaphragmatic Nodule 1 (2%)
Inflammation 43 (86%)
Mixed Cell Focus 1 (2%)
Mixed Cell Focus, Multiple 28 (56%)
Necrosis 8 (16%)
Pigmentation 45 (90%)
Toxic Hepatopathy 16 (32%)
Vacuolization Cytoplasmic 1 (2%)
Bile Duct, Cyst 6 (12%)
Bile Duct, Fibrosis 5 (10%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 11
NTP Experiment-Test: 96007-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION (TCDD) Date: 09/30/03
Route: GAVAGE Time: 08:37:05
____________________________________________________________________________________________________________________________________
SPRAGUE-DAWLEY RATS FEMALE 100 NG/
KG/STOP
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Bile Duct, Hyperplasia 7 (14%)
Hepatocyte, Hypertrophy 22 (44%)
Hepatocyte, Multinucleated 32 (64%)
Oval Cell, Hyperplasia 1 (2%)
Portal, Fibrosis 1 (2%)
Serosa, Inflammation, Chronic Active 1 (2%)
Mesentery (1)
Artery, Inflammation, Chronic Active 1 (100%)
Oral Mucosa (11)
Gingival, Hyperplasia, Squamous 8 (73%)
Pancreas (49)
Angiectasis 1 (2%)
Basophilic Focus 1 (2%)
Inflammation, Chronic Active 4 (8%)
Acinus, Atrophy 4 (8%)
Artery, Inflammation, Chronic Active 2 (4%)
Salivary Glands (49)
Atrophy 2 (4%)
Fibrosis 1 (2%)
Inflammation 1 (2%)
Stomach, Forestomach (50)
Hyperkeratosis 1 (2%)
Hyperplasia, Squamous 5 (10%)
Inflammation 4 (8%)
Ulcer 4 (8%)
Stomach, Glandular (50)
Erosion 1 (2%)
Tongue (1)
Inflammation, Chronic Active 1 (100%)
Tooth (12)
Peridontal Tissue, Inflammation 12 (100%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (50)
Cardiomyopathy 22 (44%)
Inflammation 1 (2%)
Atrium, Thrombosis 2 (4%)
Epicardium, Inflammation, Chronic Active 1 (2%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 12
NTP Experiment-Test: 96007-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION (TCDD) Date: 09/30/03
Route: GAVAGE Time: 08:37:05
____________________________________________________________________________________________________________________________________
SPRAGUE-DAWLEY RATS FEMALE 100 NG/
KG/STOP
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (50)
Angiectasis 15 (30%)
Atrophy 4 (8%)
Degeneration, Cystic 17 (34%)
Hyperplasia 20 (40%)
Hypertrophy 46 (92%)
Necrosis 3 (6%)
Vacuolization Cytoplasmic 13 (26%)
Adrenal Medulla (50)
Hyperplasia 15 (30%)
Islets, Pancreatic (49)
Hyperplasia 1 (2%)
Pituitary Gland (50)
Angiectasis 15 (30%)
Cytoplasmic Alteration 1 (2%)
Vacuolization Cytoplasmic 3 (6%)
Pars Distalis, Hyperplasia 18 (36%)
Thyroid Gland (49)
Angiectasis 1 (2%)
C-Cell, Hyperplasia 15 (31%)
Follicular Cell, Hypertrophy 6 (12%)
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GENERAL BODY SYSTEM
None
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GENITAL SYSTEM
Clitoral Gland (49)
Atrophy 1 (2%)
Hyperplasia, Basal Cell 1 (2%)
Hyperplasia, Squamous 1 (2%)
Inflammation 35 (71%)
Duct, Cyst 35 (71%)
Ovary (49)
Atrophy 45 (92%)
Cyst 16 (33%)
Inflammation, Granulomatous 1 (2%)
Oviduct (2)
Inflammation 2 (100%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 13
NTP Experiment-Test: 96007-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION (TCDD) Date: 09/30/03
Route: GAVAGE Time: 08:37:05
____________________________________________________________________________________________________________________________________
SPRAGUE-DAWLEY RATS FEMALE 100 NG/
KG/STOP
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM - CONT
Uterus (50)
Inflammation, Chronic Active 1 (2%)
Inflammation, Suppurative 9 (18%)
Metaplasia, Squamous 33 (66%)
Cervix, Inflammation, Chronic Active 1 (2%)
Endometrium, Hyperplasia, Cystic 32 (64%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (50)
Atrophy 1 (2%)
Hyperplasia 36 (72%)
Myelofibrosis 1 (2%)
Lymph Node (5)
Lumbar, Ectasia 2 (40%)
Lumbar, Hyperplasia, Plasma Cell 2 (40%)
Mediastinal, Hemorrhage 1 (20%)
Mediastinal, Hyperplasia, Plasma Cell 1 (20%)
Lymph Node, Mandibular (49)
Ectasia 2 (4%)
Hyperplasia, Lymphoid 2 (4%)
Hyperplasia, Plasma Cell 30 (61%)
Lymph Node, Mesenteric (49)
Hyperplasia, Histiocytic 1 (2%)
Spleen (49)
Hematopoietic Cell Proliferation 42 (86%)
Hyperplasia, Lymphoid 1 (2%)
Pigmentation 42 (86%)
Lymphoid Follicle, Atrophy 1 (2%)
Red Pulp, Atrophy 1 (2%)
Thymus (49)
Atrophy 45 (92%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (50)
Cyst 4 (8%)
Hyperplasia 19 (38%)
Skin (50)
Ulcer 1 (2%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 14
NTP Experiment-Test: 96007-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION (TCDD) Date: 09/30/03
Route: GAVAGE Time: 08:37:05
____________________________________________________________________________________________________________________________________
SPRAGUE-DAWLEY RATS FEMALE 100 NG/
KG/STOP
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
None
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50)
Hemorrhage 1 (2%)
Inflammation, Suppurative 1 (2%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50)
Infiltration Cellular, Histiocyte 41 (82%)
Inflammation, Suppurative 1 (2%)
Metaplasia, Squamous 3 (6%)
Alveolar Epithelium, Metaplasia, Bronchiolar 31 (62%)
Serosa, Inflammation, Suppurative 1 (2%)
Nose (50)
Inflammation 1 (2%)
Goblet Cell, Respiratory Epithelium,
Hyperplasia 1 (2%)
Nasolacrimal Duct, Inflammation 1 (2%)
Olfactory Epithelium, Degeneration 1 (2%)
Olfactory Epithelium, Inflammation 1 (2%)
Olfactory Epithelium, Glands, Hyperplasia 1 (2%)
Respiratory Epithelium, Cyst 1 (2%)
Respiratory Epithelium, Inflammation,
Suppurative 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (50)
Retinal Detachment 1 (2%)
Bilateral, Cataract 1 (2%)
Retina, Atrophy 6 (12%)
Retina, Degeneration 1 (2%)
Harderian Gland (50)
Hemorrhage 1 (2%)
Inflammation 9 (18%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 15
NTP Experiment-Test: 96007-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION (TCDD) Date: 09/30/03
Route: GAVAGE Time: 08:37:05
____________________________________________________________________________________________________________________________________
SPRAGUE-DAWLEY RATS FEMALE 100 NG/
KG/STOP
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50)
Accumulation, Hyaline Droplet 2 (4%)
Casts Protein 1 (2%)
Mineralization 42 (84%)
Nephropathy 41 (82%)
Papilla, Transitional Epithelium, Hyperplasia 1 (2%)
Pelvis, Dilatation 1 (2%)
Transitional Epithelium, Hyperplasia 5 (10%)
Urinary Bladder (50)
Inflammation 2 (4%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 16
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