TDMS Study 96007-05 Pathology Tables
NTP Experiment-Test: 96007-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION(PECDF) Date: 09/30/03
Route: GAVAGE Time: 11:22:49
FINAL #3/RATS
Facility: Battelle Columbus Laboratory
Chemical CAS #: 57117-31-4
Lock Date: 07/25/02
Cage Range: All
Reasons For Removal: 25018 Dosing Accident 25019 Moribund Sacrifice
25020 Natural Death 25021 Terminal Sacrifice
Removal Date Range: All
Treatment Groups: Include All
a Number of animals examined microscopically at site and number of animals with lesion
Page 1
NTP Experiment-Test: 96007-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION(PECDF) Date: 09/30/03
Route: GAVAGE Time: 11:22:49
____________________________________________________________________________________________________________________________________
SPRAGUE-DAWLEY RATS FEMALE 0 NG/KG 6 NG/KG 20 NG/KG 44 NG/KG 92 NG/KG 200
NG/KG
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 98 98 98 98 98 98
Early Deaths
Natural Death 7 10 10 8 14 11
Moribund Sacrifice 21 20 17 19 19 19
Dosing Accident 1 2 1
Survivors
Terminal Sacrifice 25 22 24 25 20 23
Animals Examined Microscopically 53 53 53 53 53 53
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Esophagus (53) (53) (52) (53) (53) (53)
Cyst 2 (4%)
Perforation 1 (2%) 2 (4%) 1 (2%)
Muscularis, Inflammation 2 (4%) 1 (2%) 1 (2%) 1 (2%) 1 (2%)
Periesophageal Tissue, Inflammation 1 (2%) 2 (4%) 2 (4%) 1 (2%)
Intestine Large, Colon (53) (53) (53) (53) (51) (53)
Edema 1 (2%)
Inflammation 1 (2%) 1 (2%)
Parasite Metazoan 2 (4%)
Intestine Large, Rectum (53) (53) (53) (53) (52) (53)
Parasite Metazoan 4 (8%) 5 (9%) 5 (9%) 1 (2%) 1 (2%) 1 (2%)
Artery, Inflammation, Chronic Active 1 (2%) 1 (2%)
Intestine Large, Cecum (53) (53) (53) (52) (51) (53)
Inflammation 1 (2%)
Artery, Inflammation, Chronic Active 1 (2%) 2 (4%)
Artery, Mineralization 1 (2%)
Intestine Small, Ileum (53) (53) (53) (52) (52) (53)
Parasite Metazoan 1 (2%)
Liver (53) (53) (53) (52) (53) (53)
Angiectasis 6 (11%) 3 (6%) 4 (8%) 1 (2%) 1 (2%)
Basophilic Focus 10 (19%) 11 (21%) 9 (17%) 10 (19%) 12 (23%) 6 (11%)
Basophilic Focus, Multiple 12 (23%) 12 (23%) 11 (21%) 6 (12%) 3 (6%) 1 (2%)
Cholangiofibrosis 1 (2%) 3 (6%) 3 (6%) 5 (9%)
Clear Cell Focus 11 (21%) 1 (2%) 7 (13%) 2 (4%) 3 (6%)
Clear Cell Focus, Multiple 2 (4%) 5 (9%) 3 (6%) 1 (2%) 6 (11%) 8 (15%)
Degeneration, Cystic 1 (2%)
Eosinophilic Focus 7 (13%) 11 (21%) 9 (17%) 9 (17%) 11 (21%) 10 (19%)
Eosinophilic Focus, Multiple 8 (15%) 2 (4%) 9 (17%) 9 (17%) 12 (23%) 18 (34%)
Fatty Change, Diffuse 1 (2%) 4 (8%) 10 (19%) 12 (23%) 20 (38%) 26 (49%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 2
NTP Experiment-Test: 96007-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION(PECDF) Date: 09/30/03
Route: GAVAGE Time: 11:22:49
____________________________________________________________________________________________________________________________________
SPRAGUE-DAWLEY RATS FEMALE 0 NG/KG 6 NG/KG 20 NG/KG 44 NG/KG 92 NG/KG 200
NG/KG
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Fatty Change, Focal 5 (9%) 6 (11%) 5 (9%) 6 (12%) 6 (11%) 4 (8%)
Hematopoietic Cell Proliferation 24 (45%) 28 (53%) 27 (51%) 24 (46%) 39 (74%) 31 (58%)
Hemorrhage 1 (2%)
Hepatodiaphragmatic Nodule 3 (6%) 3 (6%) 3 (6%) 1 (2%) 1 (2%) 1 (2%)
Hyperplasia, Nodular 3 (6%) 8 (15%) 12 (23%)
Inflammation 47 (89%) 44 (83%) 47 (89%) 50 (96%) 48 (91%) 50 (94%)
Mixed Cell Focus 5 (9%) 1 (2%) 2 (4%) 2 (4%) 1 (2%)
Mixed Cell Focus, Multiple 28 (53%) 24 (45%) 23 (43%) 27 (52%) 25 (47%) 25 (47%)
Necrosis 4 (8%) 10 (19%) 3 (6%) 3 (6%) 6 (11%) 18 (34%)
Pigmentation 13 (25%) 11 (21%) 21 (40%) 44 (85%) 42 (79%) 48 (91%)
Toxic Hepatopathy 2 (4%) 3 (6%) 8 (15%) 27 (51%) 44 (83%)
Artery, Inflammation, Chronic Active 1 (2%)
Bile Duct, Cyst 7 (13%) 4 (8%) 2 (4%) 3 (6%) 2 (4%) 7 (13%)
Bile Duct, Fibrosis 1 (2%) 4 (8%) 2 (4%) 2 (4%) 3 (6%) 6 (11%)
Bile Duct, Hyperplasia 3 (6%) 2 (4%) 2 (4%) 2 (4%) 1 (2%) 13 (25%)
Centrilobular, Degeneration 4 (8%) 2 (4%) 3 (6%) 4 (8%) 4 (8%) 5 (9%)
Hepatocyte, Hypertrophy 2 (4%) 13 (25%) 17 (32%) 17 (33%) 24 (45%) 34 (64%)
Hepatocyte, Multinucleated 4 (8%) 13 (25%) 18 (34%) 35 (66%)
Oval Cell, Hyperplasia 1 (2%) 4 (8%) 2 (4%) 6 (12%) 15 (28%) 35 (66%)
Portal, Fibrosis 1 (2%)
Mesentery (1) (2) (1) (3) (2) (4)
Inflammation 1 (50%)
Necrosis 1 (100%)
Artery, Inflammation, Chronic Active 1 (50%) 2 (67%) 1 (50%) 4 (100%)
Fat, Necrosis 1 (100%) 1 (33%) 1 (50%)
Oral Mucosa (52) (53) (52) (53) (53) (53)
Gingival, Cyst 1 (2%)
Gingival, Hyperplasia 1 (2%)
Gingival, Hyperplasia, Squamous 15 (29%) 11 (21%) 16 (31%) 19 (36%) 22 (42%) 20 (38%)
Pancreas (53) (53) (53) (52) (52) (52)
Cyst 1 (2%)
Cytoplasmic Alteration 3 (6%)
Inflammation, Chronic Active 2 (4%) 1 (2%) 1 (2%) 1 (2%) 4 (8%)
Lipomatosis 1 (2%)
Acinus, Atrophy 3 (6%) 1 (2%) 1 (2%) 1 (2%) 3 (6%)
Acinus, Hyperplasia 1 (2%)
Acinus, Vacuolization Cytoplasmic 2 (4%) 23 (44%)
Artery, Inflammation, Chronic Active 1 (2%) 2 (4%) 1 (2%) 2 (4%) 4 (8%) 11 (21%)
Duct, Dilatation 1 (2%)
Salivary Glands (53) (53) (51) (53) (51) (51)
Atrophy 1 (2%) 2 (4%)
Duct, Inflammation 1 (2%)
Stomach, Forestomach (53) (53) (53) (53) (52) (53)
a Number of animals examined microscopically at site and number of animals with lesion
Page 3
NTP Experiment-Test: 96007-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION(PECDF) Date: 09/30/03
Route: GAVAGE Time: 11:22:49
____________________________________________________________________________________________________________________________________
SPRAGUE-DAWLEY RATS FEMALE 0 NG/KG 6 NG/KG 20 NG/KG 44 NG/KG 92 NG/KG 200
NG/KG
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Cyst 1 (2%)
Edema 1 (2%)
Hyperkeratosis 1 (2%)
Hyperplasia, Squamous 4 (8%) 1 (2%) 5 (9%) 6 (11%) 3 (6%) 10 (19%)
Inflammation 1 (2%) 1 (2%) 2 (4%) 2 (4%) 2 (4%)
Mineralization 1 (2%)
Ulcer 1 (2%) 2 (4%) 2 (4%) 1 (2%) 1 (2%)
Artery, Inflammation, Chronic Active 1 (2%) 3 (6%)
Stomach, Glandular (53) (53) (53) (53) (52) (53)
Erosion 1 (2%) 2 (4%) 1 (2%)
Hyperplasia 1 (2%)
Inflammation 1 (2%) 1 (2%)
Mineralization 2 (4%) 9 (17%) 1 (2%) 3 (6%) 2 (4%) 4 (8%)
Ulcer 1 (2%)
Artery, Inflammation, Chronic Active 1 (2%) 1 (2%)
Serosa, Inflammation 1 (2%)
Tooth (33) (25) (22) (30) (29) (29)
Peridontal Tissue, Inflammation 33 (100%) 25 (100%) 22 (100%) 30 (100%) 29 (100%) 29 (100%)
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CARDIOVASCULAR SYSTEM
Blood Vessel (53) (53) (53) (53) (53) (53)
Aorta, Mineralization 1 (2%) 1 (2%) 2 (4%)
Aorta, Adventitia, Inflammation, Chronic
Active 1 (2%)
Heart (53) (53) (52) (53) (53) (52)
Cardiomyopathy 15 (28%) 12 (23%) 19 (37%) 13 (25%) 18 (34%) 24 (46%)
Hemorrhage 2 (4%)
Infiltration Cellular, Mononuclear Cell 1 (2%)
Inflammation 1 (2%) 1 (2%) 1 (2%)
Mineralization 1 (2%) 1 (2%) 1 (2%)
Artery, Inflammation, Chronic Active 1 (2%) 2 (4%)
Epicardium, Inflammation 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (53) (53) (53) (52) (53) (53)
Angiectasis 31 (58%) 37 (70%) 30 (57%) 33 (63%) 27 (51%) 35 (66%)
Atrophy 3 (6%) 1 (2%) 4 (8%)
Degeneration, Cystic 4 (8%) 17 (32%) 14 (26%) 18 (35%) 12 (23%) 14 (26%)
Hematopoietic Cell Proliferation 1 (2%) 1 (2%) 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 4
NTP Experiment-Test: 96007-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION(PECDF) Date: 09/30/03
Route: GAVAGE Time: 11:22:49
____________________________________________________________________________________________________________________________________
SPRAGUE-DAWLEY RATS FEMALE 0 NG/KG 6 NG/KG 20 NG/KG 44 NG/KG 92 NG/KG 200
NG/KG
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM - CONT
Hemorrhage 1 (2%) 1 (2%)
Hyperplasia 8 (15%) 10 (19%) 10 (19%) 7 (13%) 10 (19%) 11 (21%)
Hypertrophy 42 (79%) 43 (81%) 43 (81%) 46 (88%) 44 (83%) 45 (85%)
Necrosis 4 (8%) 2 (4%) 2 (4%)
Vacuolization Cytoplasmic 9 (17%) 13 (25%) 14 (26%) 7 (13%) 17 (32%) 9 (17%)
Adrenal Medulla (53) (53) (53) (52) (53) (53)
Hyperplasia 11 (21%) 12 (23%) 14 (26%) 14 (27%) 7 (13%) 10 (19%)
Islets, Pancreatic (53) (53) (53) (52) (52) (52)
Hyperplasia 2 (4%)
Parathyroid Gland (49) (51) (44) (51) (49) (49)
Hyperplasia 1 (2%) 1 (2%) 1 (2%) 1 (2%)
Hypertrophy 1 (2%)
Pituitary Gland (53) (53) (53) (53) (53) (53)
Angiectasis 20 (38%) 21 (40%) 20 (38%) 13 (25%) 12 (23%) 14 (26%)
Atrophy 1 (2%)
Cyst 2 (4%) 1 (2%) 1 (2%) 1 (2%)
Cytoplasmic Alteration 1 (2%) 1 (2%)
Vacuolization Cytoplasmic 2 (4%) 2 (4%) 1 (2%)
Pars Distalis, Hyperplasia 22 (42%) 16 (30%) 14 (26%) 11 (21%) 15 (28%) 19 (36%)
Pars Intermedia, Hyperplasia 1 (2%)
Rathke's Cleft, Pars Intermedia, Hyperplasia 1 (2%)
Thyroid Gland (53) (53) (51) (53) (51) (51)
Inflammation 1 (2%)
C-Cell, Hyperplasia 15 (28%) 16 (30%) 9 (18%) 13 (25%) 9 (18%) 11 (22%)
Follicle, Cyst 1 (2%) 1 (2%) 1 (2%)
Follicular Cell, Hypertrophy 7 (13%) 13 (25%) 24 (47%) 24 (45%) 24 (47%) 22 (43%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
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GENITAL SYSTEM
Clitoral Gland (53) (51) (53) (53) (50) (53)
Hyperplasia, Squamous 1 (2%)
Inflammation 52 (98%) 47 (92%) 46 (87%) 51 (96%) 47 (94%) 47 (89%)
Duct, Cyst 40 (75%) 37 (73%) 34 (64%) 41 (77%) 44 (88%) 40 (75%)
Ovary (53) (53) (53) (52) (52) (53)
Atrophy 43 (81%) 40 (75%) 38 (72%) 43 (83%) 45 (87%) 45 (85%)
Cyst 11 (21%) 18 (34%) 20 (38%) 17 (33%) 18 (35%) 13 (25%)
Fibrosis 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 5
NTP Experiment-Test: 96007-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION(PECDF) Date: 09/30/03
Route: GAVAGE Time: 11:22:49
____________________________________________________________________________________________________________________________________
SPRAGUE-DAWLEY RATS FEMALE 0 NG/KG 6 NG/KG 20 NG/KG 44 NG/KG 92 NG/KG 200
NG/KG
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM - CONT
Inflammation, Chronic Active 1 (2%) 1 (2%) 1 (2%)
Oviduct (1) (1)
Cyst 1 (100%)
Inflammation, Chronic Active 1 (100%)
Uterus (53) (53) (53) (52) (52) (53)
Adenomyosis 1 (2%) 1 (2%) 1 (2%)
Cyst 1 (2%) 1 (2%)
Hemorrhage 1 (2%) 2 (4%)
Inflammation, Chronic Active 5 (9%) 3 (6%) 3 (6%) 4 (8%) 3 (6%)
Inflammation, Suppurative 3 (6%) 6 (11%) 1 (2%) 7 (13%) 3 (6%) 4 (8%)
Metaplasia, Squamous 17 (32%) 25 (47%) 21 (40%) 36 (69%) 31 (60%) 35 (66%)
Ulcer 1 (2%) 3 (6%) 1 (2%)
Cervix, Cyst 1 (2%)
Endometrium, Hyperplasia, Cystic 31 (58%) 29 (55%) 29 (55%) 33 (63%) 39 (75%) 37 (70%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (53) (53) (53) (53) (53) (53)
Atrophy 2 (4%)
Hyperplasia 38 (72%) 32 (60%) 37 (70%) 35 (66%) 42 (79%) 41 (77%)
Hyperplasia, Reticulum Cell 1 (2%)
Lymph Node (5) (4) (4) (4) (3) (7)
Hyperplasia, Plasma Cell 1 (14%)
Iliac, Ectasia 1 (25%)
Lumbar, Ectasia 2 (40%) 1 (25%) 1 (33%)
Lumbar, Hemorrhage 2 (40%) 1 (25%)
Lumbar, Hyperplasia, Histiocytic 1 (25%) 1 (33%)
Lumbar, Hyperplasia, Plasma Cell 1 (25%) 1 (25%) 1 (25%) 1 (14%)
Mediastinal, Ectasia 2 (67%) 2 (29%)
Mediastinal, Hemorrhage 1 (25%) 1 (14%)
Mediastinal, Hyperplasia, Lymphoid 1 (25%)
Mediastinal, Hyperplasia, Plasma Cell 1 (25%) 1 (25%) 1 (33%) 2 (29%)
Popliteal, Ectasia 1 (20%)
Lymph Node, Mandibular (53) (53) (51) (53) (51) (51)
Congestion 1 (2%)
Ectasia 1 (2%) 2 (4%) 1 (2%) 1 (2%) 1 (2%)
Hyperplasia, Histiocytic 1 (2%)
Hyperplasia, Lymphoid 1 (2%) 1 (2%)
Hyperplasia, Plasma Cell 38 (72%) 40 (75%) 38 (75%) 31 (58%) 30 (59%) 29 (57%)
Lymph Node, Mesenteric (53) (53) (53) (52) (52) (53)
Atrophy 1 (2%)
Hemorrhage 1 (2%) 1 (2%) 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 6
NTP Experiment-Test: 96007-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION(PECDF) Date: 09/30/03
Route: GAVAGE Time: 11:22:49
____________________________________________________________________________________________________________________________________
SPRAGUE-DAWLEY RATS FEMALE 0 NG/KG 6 NG/KG 20 NG/KG 44 NG/KG 92 NG/KG 200
NG/KG
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - CONT
Hyperplasia, Histiocytic 1 (2%)
Hyperplasia, Lymphoid 1 (2%) 1 (2%) 1 (2%)
Hyperplasia, Plasma Cell 1 (2%) 1 (2%)
Spleen (53) (53) (53) (52) (52) (51)
Accessory Spleen 1 (2%) 1 (2%)
Congestion 1 (2%) 1 (2%)
Hematopoietic Cell Proliferation 49 (92%) 49 (92%) 48 (91%) 51 (98%) 46 (88%) 50 (98%)
Hemorrhage 1 (2%)
Infarct 1 (2%)
Necrosis 1 (2%)
Pigmentation 52 (98%) 45 (85%) 50 (94%) 48 (92%) 49 (94%) 51 (100%)
Lymphatic, Angiectasis 1 (2%)
Lymphoid Follicle, Atrophy 7 (13%) 8 (15%) 7 (13%) 6 (12%) 12 (23%) 4 (8%)
Red Pulp, Atrophy 2 (4%)
Red Pulp, Hyperplasia 1 (2%)
Thymus (53) (49) (50) (52) (49) (51)
Atrophy 43 (81%) 36 (73%) 36 (72%) 44 (85%) 39 (80%) 48 (94%)
Hemorrhage 1 (2%) 1 (2%) 1 (2%) 1 (2%)
Hyperplasia, Lymphoid 1 (2%)
Inflammation 1 (2%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (53) (53) (53) (53) (53) (53)
Cyst 1 (2%) 2 (4%) 5 (9%) 4 (8%) 3 (6%)
Hyperplasia 33 (62%) 29 (55%) 26 (49%) 20 (38%) 20 (38%) 17 (32%)
Inflammation, Granulomatous 2 (4%) 4 (8%) 3 (6%) 4 (8%) 4 (8%) 3 (6%)
Skin (53) (53) (53) (53) (53) (53)
Inflammation 2 (4%) 1 (2%)
Ulcer 2 (4%) 1 (2%)
Conjunctiva, Inflammation 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
None
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (53) (53) (53) (53) (53) (53)
Edema 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 7
NTP Experiment-Test: 96007-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION(PECDF) Date: 09/30/03
Route: GAVAGE Time: 11:22:49
____________________________________________________________________________________________________________________________________
SPRAGUE-DAWLEY RATS FEMALE 0 NG/KG 6 NG/KG 20 NG/KG 44 NG/KG 92 NG/KG 200
NG/KG
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM - CONT
Gliosis 1 (2%)
Hemorrhage 1 (2%) 1 (2%)
Hydrocephalus 1 (2%) 1 (2%) 1 (2%)
Peripheral Nerve (1) (1)
Radicular Neuropathy 1 (100%)
Spinal Cord (1) (1)
Degeneration 1 (100%)
Hemorrhage 1 (100%)
Necrosis 1 (100%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (53) (53) (53) (53) (53) (52)
Edema 1 (2%)
Hemorrhage 1 (2%)
Infiltration Cellular, Histiocyte 44 (83%) 44 (83%) 40 (75%) 40 (75%) 41 (77%) 36 (69%)
Inflammation 5 (9%) 8 (15%) 7 (13%) 6 (11%) 7 (13%) 8 (15%)
Metaplasia, Squamous 2 (4%) 4 (8%) 3 (6%)
Mineralization 1 (2%) 1 (2%)
Alveolar Epithelium, Hyperplasia 14 (26%) 17 (32%) 12 (23%) 20 (38%) 8 (15%) 3 (6%)
Alveolar Epithelium, Metaplasia, Bronchiolar 5 (9%) 6 (11%) 5 (9%) 9 (17%) 23 (43%) 28 (54%)
Alveolus, Metaplasia, Squamous 1 (2%)
Nose (53) (53) (53) (53) (53) (53)
Inflammation 8 (15%) 3 (6%) 8 (15%) 11 (21%) 7 (13%) 6 (11%)
Mineralization 1 (2%)
Olfactory Epithelium, Metaplasia 1 (2%)
Respiratory Epithelium, Hyperplasia 1 (2%) 1 (2%) 2 (4%) 1 (2%) 6 (11%) 3 (6%)
Respiratory Epithelium, Metaplasia 1 (2%)
Septum, Inflammation 1 (2%) 2 (4%) 3 (6%) 2 (4%) 5 (9%) 3 (6%)
Squamous Epithelium, Hyperplasia 1 (2%) 1 (2%) 1 (2%)
Trachea (53) (53) (52) (53) (53) (53)
Inflammation 1 (2%) 1 (2%)
Artery, Peritracheal Tissue, Inflammation,
Chronic Active 1 (2%)
Peritracheal Tissue, Inflammation 1 (2%) 2 (4%) 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (53) (53) (52) (53) (52) (52)
Hemorrhage 1 (2%)
Inflammation 1 (2%) 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 8
NTP Experiment-Test: 96007-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION(PECDF) Date: 09/30/03
Route: GAVAGE Time: 11:22:49
____________________________________________________________________________________________________________________________________
SPRAGUE-DAWLEY RATS FEMALE 0 NG/KG 6 NG/KG 20 NG/KG 44 NG/KG 92 NG/KG 200
NG/KG
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM - CONT
Cornea, Inflammation 1 (2%)
Lens, Degeneration 1 (2%)
Retina, Atrophy 1 (2%)
Retina, Degeneration 1 (2%)
Harderian Gland (53) (53) (53) (53) (52) (52)
Inflammation 16 (30%) 9 (17%) 10 (19%) 13 (25%) 8 (15%) 6 (12%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (53) (53) (53) (52) (53) (53)
Accumulation, Hyaline Droplet 1 (2%)
Calculus Micro Observation Only 5 (9%) 2 (4%) 4 (8%) 1 (2%) 2 (4%) 3 (6%)
Cyst 1 (2%) 2 (4%) 1 (2%)
Fibrosis 1 (2%)
Hemorrhage 1 (2%)
Inflammation, Chronic Active 1 (2%) 1 (2%)
Inflammation, Suppurative 2 (4%) 1 (2%) 1 (2%) 3 (6%) 2 (4%) 2 (4%)
Mineralization 37 (70%) 45 (85%) 42 (79%) 43 (83%) 43 (81%) 31 (58%)
Necrosis 2 (4%)
Nephropathy 34 (64%) 39 (74%) 35 (66%) 42 (81%) 36 (68%) 45 (85%)
Pigmentation 2 (4%)
Artery, Inflammation, Chronic Active 1 (2%) 1 (2%)
Capsule, Hemorrhage 1 (2%)
Pelvis, Dilatation 1 (2%) 2 (4%) 1 (2%)
Pelvis, Inflammation 1 (2%) 1 (2%) 5 (9%) 1 (2%)
Renal Tubule, Dilatation 1 (2%)
Renal Tubule, Hyperplasia 1 (2%)
Renal Tubule, Necrosis 1 (2%)
Renal Tubule, Nephropathy 1 (2%)
Transitional Epithelium, Hyperplasia 2 (4%) 2 (4%) 1 (2%) 2 (4%) 6 (11%) 5 (9%)
Urinary Bladder (53) (52) (53) (53) (51) (53)
Infiltration Cellular, Lymphoid 1 (2%)
Inflammation 2 (4%) 3 (6%) 1 (2%) 1 (2%) 6 (12%) 1 (2%)
Transitional Epithelium, Hyperplasia 1 (2%) 4 (8%) 4 (8%)
Transitional Epithelium, Metaplasia, Squamous 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 9
NTP Experiment-Test: 96007-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION(PECDF) Date: 09/30/03
Route: GAVAGE Time: 11:22:49
____________________________________________________________________________________________________________________________________
SPRAGUE-DAWLEY RATS FEMALE 200 NG/
KG STOP
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 50
Early Deaths
Moribund Sacrifice 25
Natural Death 10
Survivors
Terminal Sacrifice 15
Animals Examined Microscopically 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Intestine Large, Rectum (50)
Parasite Metazoan 2 (4%)
Liver (50)
Angiectasis 1 (2%)
Basophilic Focus 9 (18%)
Basophilic Focus, Multiple 4 (8%)
Cholangiofibrosis 3 (6%)
Clear Cell Focus 4 (8%)
Clear Cell Focus, Multiple 2 (4%)
Degeneration, Cystic 1 (2%)
Eosinophilic Focus 8 (16%)
Eosinophilic Focus, Multiple 14 (28%)
Fatty Change, Diffuse 6 (12%)
Fatty Change, Focal 7 (14%)
Hematopoietic Cell Proliferation 31 (62%)
Hepatodiaphragmatic Nodule 1 (2%)
Inflammation 48 (96%)
Mixed Cell Focus 5 (10%)
Mixed Cell Focus, Multiple 19 (38%)
Necrosis 11 (22%)
Pigmentation 48 (96%)
Toxic Hepatopathy 9 (18%)
Bile Duct, Cyst 2 (4%)
Bile Duct, Fibrosis 1 (2%)
Bile Duct, Hyperplasia 1 (2%)
Centrilobular, Degeneration 7 (14%)
Hepatocyte, Hypertrophy 14 (28%)
Hepatocyte, Multinucleated 25 (50%)
Oval Cell, Hyperplasia 3 (6%)
Mesentery (2)
a Number of animals examined microscopically at site and number of animals with lesion
Page 10
NTP Experiment-Test: 96007-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION(PECDF) Date: 09/30/03
Route: GAVAGE Time: 11:22:49
____________________________________________________________________________________________________________________________________
SPRAGUE-DAWLEY RATS FEMALE 200 NG/
KG STOP
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Inflammation, Chronic Active 1 (50%)
Necrosis 1 (50%)
Oral Mucosa (50)
Gingival, Hyperplasia, Squamous 14 (28%)
Pancreas (49)
Acinus, Vacuolization Cytoplasmic 2 (4%)
Artery, Inflammation, Chronic Active 1 (2%)
Stomach, Forestomach (50)
Erosion 1 (2%)
Hyperkeratosis 1 (2%)
Hyperplasia, Squamous 5 (10%)
Inflammation 1 (2%)
Ulcer 1 (2%)
Stomach, Glandular (50)
Mineralization 3 (6%)
Tooth (24)
Peridontal Tissue, Inflammation 24 (100%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (50)
Cardiomyopathy 13 (26%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (48)
Angiectasis 29 (60%)
Degeneration, Cystic 12 (25%)
Hyperplasia 7 (15%)
Hypertrophy 36 (75%)
Necrosis 3 (6%)
Vacuolization Cytoplasmic 10 (21%)
Bilateral, Inflammation, Chronic Active 1 (2%)
Adrenal Medulla (48)
Hyperplasia 7 (15%)
Parathyroid Gland (47)
Fibrosis 1 (2%)
Pituitary Gland (49)
Angiectasis 13 (27%)
Cyst 1 (2%)
Cytoplasmic Alteration 2 (4%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 11
NTP Experiment-Test: 96007-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION(PECDF) Date: 09/30/03
Route: GAVAGE Time: 11:22:49
____________________________________________________________________________________________________________________________________
SPRAGUE-DAWLEY RATS FEMALE 200 NG/
KG STOP
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM - CONT
Vacuolization Cytoplasmic 2 (4%)
Pars Distalis, Hyperplasia 19 (39%)
Thyroid Gland (48)
C-Cell, Hyperplasia 15 (31%)
Follicular Cell, Hypertrophy 23 (48%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Clitoral Gland (50)
Inflammation 48 (96%)
Duct, Cyst 39 (78%)
Ovary (47)
Atrophy 39 (83%)
Cyst 12 (26%)
Uterus (49)
Congestion 1 (2%)
Hemorrhage 1 (2%)
Inflammation, Chronic Active 7 (14%)
Inflammation, Suppurative 3 (6%)
Metaplasia, Squamous 28 (57%)
Endometrium, Hyperplasia, Cystic 35 (71%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (50)
Hyperplasia 43 (86%)
Lymph Node (3)
Iliac, Ectasia 1 (33%)
Iliac, Hyperplasia, Plasma Cell 1 (33%)
Lumbar, Ectasia 1 (33%)
Lumbar, Hyperplasia, Plasma Cell 1 (33%)
Renal, Ectasia 1 (33%)
Renal, Hyperplasia, Plasma Cell 1 (33%)
Lymph Node, Mandibular (49)
Ectasia 1 (2%)
Hyperplasia, Lymphoid 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 12
NTP Experiment-Test: 96007-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION(PECDF) Date: 09/30/03
Route: GAVAGE Time: 11:22:49
____________________________________________________________________________________________________________________________________
SPRAGUE-DAWLEY RATS FEMALE 200 NG/
KG STOP
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - CONT
Hyperplasia, Plasma Cell 29 (59%)
Spleen (49)
Hematopoietic Cell Proliferation 49 (100%)
Pigmentation 48 (98%)
Lymphoid Follicle, Atrophy 2 (4%)
Thymus (49)
Atrophy 44 (90%)
Hemorrhage 1 (2%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (50)
Cyst 3 (6%)
Hyperplasia 19 (38%)
Inflammation 1 (2%)
Inflammation, Granulomatous 1 (2%)
Skin (50)
Hyperkeratosis 1 (2%)
Lip, Inflammation, Chronic Active 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (50)
Osteopetrosis 1 (2%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (49)
Mineralization 1 (2%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50)
Congestion 1 (2%)
Hemorrhage 2 (4%)
Infiltration Cellular, Histiocyte 30 (60%)
Inflammation 5 (10%)
Metaplasia, Squamous 1 (2%)
Mineralization 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 13
NTP Experiment-Test: 96007-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION(PECDF) Date: 09/30/03
Route: GAVAGE Time: 11:22:49
____________________________________________________________________________________________________________________________________
SPRAGUE-DAWLEY RATS FEMALE 200 NG/
KG STOP
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM - CONT
Alveolar Epithelium, Hyperplasia 6 (12%)
Alveolar Epithelium, Metaplasia, Bronchiolar 7 (14%)
Nose (50)
Inflammation 7 (14%)
Nasolacrimal Duct, Inflammation 1 (2%)
Respiratory Epithelium, Hyperplasia 2 (4%)
Trachea (50)
Inflammation 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (49)
Retina, Atrophy 1 (2%)
Harderian Gland (49)
Inflammation 6 (12%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (48)
Accumulation, Hyaline Droplet 3 (6%)
Calculus Micro Observation Only 1 (2%)
Infarct 1 (2%)
Inflammation 1 (2%)
Inflammation, Suppurative 2 (4%)
Mineralization 41 (85%)
Nephropathy 35 (73%)
Pelvis, Dilatation 1 (2%)
Pelvis, Inflammation 1 (2%)
Transitional Epithelium, Hyperplasia 3 (6%)
Urinary Bladder (50)
Inflammation 2 (4%)
Transitional Epithelium, Hyperplasia 3 (6%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 14
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