TDMS Study 96007-05 Pathology Tables
NTP Experiment-Test: 96007-05 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(PECDF) Time: 12:03:03
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
b Average severity grade (1-minimal;2-mild;3-moderate;4-marked)
Page 1
NTP Experiment-Test: 96007-05 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(PECDF) Time: 12:03:03
____________________________________________________________________________________________________________________________________
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 [3.0]
Perforation 1 [0.0] 2 [3.0] 1 [4.0]
Muscularis, Inflammation 2 [1.5] 1 [1.0] 1 [1.0] 1 [2.0] 1 [2.0]
Periesophageal Tissue, Inflammation 1 [3.0] 2 [3.0] 2 [3.0] 1 [3.0]
Intestine Large, Colon (53) (53) (53) (53) (51) (53)
Edema 1 [2.0]
Inflammation 1 [2.0] 1 [2.0]
Parasite Metazoan 2
Intestine Large, Rectum (53) (53) (53) (53) (52) (53)
Parasite Metazoan 4 5 5 1 1 1
Artery, Inflammation, Chronic Active 1 [3.0] 1 [3.0]
Intestine Large, Cecum (53) (53) (53) (52) (51) (53)
Inflammation 1 [2.0]
Artery, Inflammation, Chronic Active 1 [3.0] 2 [2.5]
Artery, Mineralization 1 [2.0]
Intestine Small, Ileum (53) (53) (53) (52) (52) (53)
Parasite Metazoan 1
Liver (53) (53) (53) (52) (53) (53)
Angiectasis 6 [1.5] 3 [1.3] 4 [1.8] 1 [2.0] 1 [2.0]
Basophilic Focus 10 11 9 10 12 6
Basophilic Focus, Multiple 12 12 11 6 3 1
Cholangiofibrosis 1 [1.0] 3 [1.3] 3 [1.3] 5 [2.2]
Clear Cell Focus 11 1 7 2 3
Clear Cell Focus, Multiple 2 5 3 1 6 8
Degeneration, Cystic 1 [1.0]
Eosinophilic Focus 7 11 9 9 11 10
Eosinophilic Focus, Multiple 8 2 9 9 12 18
Fatty Change, Diffuse 1 [1.0] 4 [1.3] 10 [1.4] 12 [1.1] 20 [1.1] 26 [1.3]
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: 96007-05 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(PECDF) Time: 12:03:03
____________________________________________________________________________________________________________________________________
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 [1.2] 6 [2.0] 5 [1.0] 6 [1.3] 6 [1.3] 4 [1.0]
Hematopoietic Cell Proliferation 24 [1.1] 28 [1.3] 27 [1.1] 24 [1.0] 39 [1.1] 31 [1.1]
Hemorrhage 1 [2.0]
Hepatodiaphragmatic Nodule 3 3 3 1 1 1
Hyperplasia, Nodular 3 8 12
Inflammation 47 [1.1] 44 [1.2] 47 [1.1] 50 [1.2] 48 [1.2] 50 [1.3]
Mixed Cell Focus 5 1 2 2 1
Mixed Cell Focus, Multiple 28 24 23 27 25 25
Necrosis 4 [2.5] 10 [2.1] 3 [2.0] 3 [2.3] 6 [2.0] 18 [1.8]
Pigmentation 13 [1.1] 11 [1.1] 21 [1.3] 44 [1.5] 42 [1.8] 48 [1.9]
Toxic Hepatopathy 2 [1.0] 3 [1.0] 8 [1.1] 27 [1.1] 44 [1.7]
Artery, Inflammation, Chronic Active 1 [1.0]
Bile Duct, Cyst 7 [2.3] 4 [2.3] 2 [3.0] 3 [2.0] 2 [2.0] 7 [1.7]
Bile Duct, Fibrosis 1 [1.0] 4 [1.8] 2 [1.0] 2 [1.5] 3 [1.0] 6 [1.3]
Bile Duct, Hyperplasia 3 [1.3] 2 [1.0] 2 [1.0] 2 [1.0] 1 [1.0] 13 [1.6]
Centrilobular, Degeneration 4 [2.0] 2 [1.5] 3 [2.3] 4 [1.5] 4 [2.3] 5 [2.4]
Hepatocyte, Hypertrophy 2 [1.0] 13 [1.0] 17 [1.0] 17 [1.0] 24 [1.0] 34 [1.2]
Hepatocyte, Multinucleated 4 [1.0] 13 [1.0] 18 [1.3] 35 [1.2]
Oval Cell, Hyperplasia 1 [1.0] 4 [1.3] 2 [1.0] 6 [1.2] 15 [1.1] 35 [1.4]
Portal, Fibrosis 1 [1.0]
Mesentery (1) (2) (1) (3) (2) (4)
Inflammation 1 [2.0]
Necrosis 1 [3.0]
Artery, Inflammation, Chronic Active 1 [3.0] 2 [3.5] 1 [4.0] 4 [3.3]
Fat, Necrosis 1 [3.0] 1 [2.0] 1 [3.0]
Oral Mucosa (52) (53) (52) (53) (53) (53)
Gingival, Cyst 1 [3.0]
Gingival, Hyperplasia 1 [1.0]
Gingival, Hyperplasia, Squamous 15 [1.1] 11 [1.4] 16 [1.4] 19 [1.2] 22 [1.1] 20 [1.4]
Pancreas (53) (53) (53) (52) (52) (52)
Cyst 1 [2.0]
Cytoplasmic Alteration 3 [2.0]
Inflammation, Chronic Active 2 [1.0] 1 [2.0] 1 [1.0] 1 [1.0] 4 [2.0]
Lipomatosis 1 [2.0]
Acinus, Atrophy 3 [1.7] 1 [4.0] 1 [1.0] 1 [2.0] 3 [2.7]
Acinus, Hyperplasia 1 [3.0]
Acinus, Vacuolization Cytoplasmic 2 [1.0] 23 [1.1]
Artery, Inflammation, Chronic Active 1 [1.0] 2 [2.0] 1 [1.0] 2 [2.5] 4 [2.3] 11 [3.3]
Duct, Dilatation 1 [4.0]
Salivary Glands (53) (53) (51) (53) (51) (51)
Atrophy 1 [2.0] 2 [1.5]
Duct, Inflammation 1 [3.0]
Stomach, Forestomach (53) (53) (53) (53) (52) (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 3
NTP Experiment-Test: 96007-05 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(PECDF) Time: 12:03:03
____________________________________________________________________________________________________________________________________
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 [3.0]
Edema 1 [2.0]
Hyperkeratosis 1 [2.0]
Hyperplasia, Squamous 4 [1.8] 1 [1.0] 5 [1.4] 6 [2.5] 3 [2.7] 10 [2.1]
Inflammation 1 [2.0] 1 [1.0] 2 [2.5] 2 [2.5] 2 [2.0]
Mineralization 1 [2.0]
Ulcer 1 [1.0] 2 [1.5] 2 [2.0] 1 [3.0] 1 [2.0]
Artery, Inflammation, Chronic Active 1 [2.0] 3 [2.7]
Stomach, Glandular (53) (53) (53) (53) (52) (53)
Erosion 1 [2.0] 2 [2.0] 1 [2.0]
Hyperplasia 1 [2.0]
Inflammation 1 [2.0] 1 [2.0]
Mineralization 2 [1.0] 9 [1.1] 1 [1.0] 3 [1.3] 2 [2.0] 4 [1.5]
Ulcer 1 [2.0]
Artery, Inflammation, Chronic Active 1 [3.0] 1 [2.0]
Serosa, Inflammation 1 [2.0]
Tooth (33) (25) (22) (30) (29) (29)
Peridontal Tissue, Inflammation 33 [1.6] 25 [1.4] 22 [1.1] 30 [1.6] 29 [1.1] 29 [1.3]
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Blood Vessel (53) (53) (53) (53) (53) (53)
Aorta, Mineralization 1 [3.0] 1 [3.0] 2 [2.5]
Aorta, Adventitia, Inflammation, Chronic
Active 1 [4.0]
Heart (53) (53) (52) (53) (53) (52)
Cardiomyopathy 15 [1.1] 12 [1.0] 19 [1.1] 13 [1.0] 18 [1.0] 24 [1.1]
Hemorrhage 2 [2.0]
Infiltration Cellular, Mononuclear Cell 1 [1.0]
Inflammation 1 [2.0] 1 [3.0] 1 [2.0]
Mineralization 1 [2.0] 1 [2.0] 1 [2.0]
Artery, Inflammation, Chronic Active 1 [2.0] 2 [1.5]
Epicardium, Inflammation 1 [3.0] 1 [2.0]
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (53) (53) (53) (52) (53) (53)
Angiectasis 31 [1.5] 37 [1.4] 30 [1.4] 33 [1.4] 27 [1.2] 35 [1.3]
Atrophy 3 [3.3] 1 [4.0] 4 [2.3]
Degeneration, Cystic 4 [2.0] 17 [1.9] 14 [2.3] 18 [2.2] 12 [2.1] 14 [2.4]
Hematopoietic Cell Proliferation 1 [2.0] 1 [1.0] 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 4
NTP Experiment-Test: 96007-05 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(PECDF) Time: 12:03:03
____________________________________________________________________________________________________________________________________
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 [4.0] 1 [3.0]
Hyperplasia 8 [2.4] 10 [2.0] 10 [2.1] 7 [2.3] 10 [2.1] 11 [1.8]
Hypertrophy 42 [1.7] 43 [1.9] 43 [2.1] 46 [2.1] 44 [2.1] 45 [2.1]
Necrosis 4 [2.3] 2 [2.0] 2 [2.0]
Vacuolization Cytoplasmic 9 [1.4] 13 [1.2] 14 [1.6] 7 [1.9] 17 [1.2] 9 [1.4]
Adrenal Medulla (53) (53) (53) (52) (53) (53)
Hyperplasia 11 [2.3] 12 [2.2] 14 [1.9] 14 [1.9] 7 [1.9] 10 [1.9]
Islets, Pancreatic (53) (53) (53) (52) (52) (52)
Hyperplasia 2 [2.5]
Parathyroid Gland (49) (51) (44) (51) (49) (49)
Hyperplasia 1 [2.0] 1 [2.0] 1 [2.0] 1 [2.0]
Hypertrophy 1 [2.0]
Pituitary Gland (53) (53) (53) (53) (53) (53)
Angiectasis 20 [1.9] 21 [2.5] 20 [2.5] 13 [2.4] 12 [2.4] 14 [2.2]
Atrophy 1 [4.0]
Cyst 2 [1.5] 1 [2.0] 1 [3.0] 1 [2.0]
Cytoplasmic Alteration 1 [1.0] 1 [1.0]
Vacuolization Cytoplasmic 2 [1.0] 2 [1.0] 1 [1.0]
Pars Distalis, Hyperplasia 22 [2.4] 16 [2.4] 14 [2.3] 11 [2.5] 15 [2.3] 19 [2.6]
Pars Intermedia, Hyperplasia 1 [2.0]
Rathke's Cleft, Pars Intermedia, Hyperplasia 1 [2.0]
Thyroid Gland (53) (53) (51) (53) (51) (51)
Inflammation 1 [3.0]
C-Cell, Hyperplasia 15 [2.1] 16 [2.2] 9 [2.3] 13 [1.9] 9 [2.0] 11 [1.8]
Follicle, Cyst 1 [2.0] 1 [2.0] 1 [2.0]
Follicular Cell, Hypertrophy 7 [1.6] 13 [1.2] 24 [1.3] 24 [1.2] 24 [1.5] 22 [1.5]
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Clitoral Gland (53) (51) (53) (53) (50) (53)
Hyperplasia, Squamous 1 [2.0]
Inflammation 52 [1.7] 47 [1.8] 46 [1.7] 51 [1.7] 47 [1.5] 47 [1.5]
Duct, Cyst 40 [2.3] 37 [2.3] 34 [2.6] 41 [2.4] 44 [2.0] 40 [2.2]
Ovary (53) (53) (53) (52) (52) (53)
Atrophy 43 [4.0] 40 [4.0] 38 [4.0] 43 [4.0] 45 [4.0] 45 [3.9]
Cyst 11 [2.2] 18 [2.1] 20 [2.1] 17 [2.3] 18 [2.3] 13 [2.5]
Fibrosis 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 5
NTP Experiment-Test: 96007-05 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(PECDF) Time: 12:03:03
____________________________________________________________________________________________________________________________________
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 [4.0] 1 [3.0] 1 [4.0]
Oviduct (1) (1)
Cyst 1 [3.0]
Inflammation, Chronic Active 1 [3.0]
Uterus (53) (53) (53) (52) (52) (53)
Adenomyosis 1 [2.0] 1 [2.0] 1 [3.0]
Cyst 1 [3.0] 1 [2.0]
Hemorrhage 1 [2.0] 2 [2.5]
Inflammation, Chronic Active 5 [2.6] 3 [2.3] 3 [3.3] 4 [3.0] 3 [2.3]
Inflammation, Suppurative 3 [1.7] 6 [1.3] 1 [1.0] 7 [1.4] 3 [1.7] 4 [1.0]
Metaplasia, Squamous 17 [1.8] 25 [1.8] 21 [1.8] 36 [1.8] 31 [1.9] 35 [1.9]
Ulcer 1 [3.0] 3 [2.7] 1 [2.0]
Cervix, Cyst 1 [3.0]
Endometrium, Hyperplasia, Cystic 31 [2.4] 29 [2.1] 29 [2.1] 33 [2.2] 39 [2.2] 37 [2.1]
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (53) (53) (53) (53) (53) (53)
Atrophy 2 [2.0]
Hyperplasia 38 [2.8] 32 [2.9] 37 [3.1] 35 [2.9] 42 [2.9] 41 [2.8]
Hyperplasia, Reticulum Cell 1 [3.0]
Lymph Node (5) (4) (4) (4) (3) (7)
Hyperplasia, Plasma Cell 1 [2.0]
Iliac, Ectasia 1 [3.0]
Lumbar, Ectasia 2 [2.0] 1 [3.0] 1 [2.0]
Lumbar, Hemorrhage 2 [2.5] 1 [2.0]
Lumbar, Hyperplasia, Histiocytic 1 [2.0] 1 [2.0]
Lumbar, Hyperplasia, Plasma Cell 1 [3.0] 1 [3.0] 1 [3.0] 1 [2.0]
Mediastinal, Ectasia 2 [1.5] 2 [2.0]
Mediastinal, Hemorrhage 1 [2.0] 1 [1.0]
Mediastinal, Hyperplasia, Lymphoid 1 [2.0]
Mediastinal, Hyperplasia, Plasma Cell 1 [3.0] 1 [3.0] 1 [3.0] 2 [1.5]
Popliteal, Ectasia 1 [2.0]
Lymph Node, Mandibular (53) (53) (51) (53) (51) (51)
Congestion 1 [2.0]
Ectasia 1 [2.0] 2 [2.0] 1 [2.0] 1 [2.0] 1 [2.0]
Hyperplasia, Histiocytic 1 [2.0]
Hyperplasia, Lymphoid 1 [3.0] 1 [4.0]
Hyperplasia, Plasma Cell 38 [2.1] 40 [2.2] 38 [2.1] 31 [2.1] 30 [2.2] 29 [2.2]
Lymph Node, Mesenteric (53) (53) (53) (52) (52) (53)
Atrophy 1 [3.0]
Hemorrhage 1 [2.0] 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 6
NTP Experiment-Test: 96007-05 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(PECDF) Time: 12:03:03
____________________________________________________________________________________________________________________________________
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 [2.0]
Hyperplasia, Lymphoid 1 [3.0] 1 [2.0] 1 [3.0]
Hyperplasia, Plasma Cell 1 [2.0] 1 [2.0]
Spleen (53) (53) (53) (52) (52) (51)
Accessory Spleen 1 1
Congestion 1 [2.0] 1 [3.0]
Hematopoietic Cell Proliferation 49 [2.0] 49 [2.2] 48 [2.3] 51 [1.9] 46 [2.2] 50 [2.0]
Hemorrhage 1 [2.0]
Infarct 1 [2.0]
Necrosis 1 [3.0]
Pigmentation 52 [1.7] 45 [1.6] 50 [1.9] 48 [1.8] 49 [1.9] 51 [1.9]
Lymphatic, Angiectasis 1 [2.0]
Lymphoid Follicle, Atrophy 7 [2.0] 8 [2.1] 7 [2.3] 6 [2.7] 12 [2.4] 4 [2.3]
Red Pulp, Atrophy 2 [2.0]
Red Pulp, Hyperplasia 1 [3.0]
Thymus (53) (49) (50) (52) (49) (51)
Atrophy 43 [2.3] 36 [2.6] 36 [2.7] 44 [2.8] 39 [3.1] 48 [3.6]
Hemorrhage 1 [2.0] 1 [2.0] 1 [2.0] 1 [2.0]
Hyperplasia, Lymphoid 1 [2.0]
Inflammation 1 [3.0]
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (53) (53) (53) (53) (53) (53)
Cyst 1 [3.0] 2 [2.5] 5 [2.2] 4 [2.5] 3 [2.3]
Hyperplasia 33 [1.3] 29 [1.3] 26 [1.5] 20 [1.6] 20 [1.2] 17 [1.1]
Inflammation, Granulomatous 2 [1.5] 4 [2.3] 3 [2.0] 4 [2.0] 4 [2.0] 3 [2.0]
Skin (53) (53) (53) (53) (53) (53)
Inflammation 2 [3.0] 1 [3.0]
Ulcer 2 [3.0] 1 [3.0]
Conjunctiva, Inflammation 1 [2.0]
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
None
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (53) (53) (53) (53) (53) (53)
Edema 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: 96007-05 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(PECDF) Time: 12:03:03
____________________________________________________________________________________________________________________________________
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 [2.0]
Hemorrhage 1 [3.0] 1 [3.0]
Hydrocephalus 1 [2.0] 1 [2.0] 1 [2.0]
Peripheral Nerve (1) (1)
Radicular Neuropathy 1 [2.0]
Spinal Cord (1) (1)
Degeneration 1 [3.0]
Hemorrhage 1 [3.0]
Necrosis 1 [2.0]
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (53) (53) (53) (53) (53) (52)
Edema 1 [2.0]
Hemorrhage 1 [4.0]
Infiltration Cellular, Histiocyte 44 [1.7] 44 [1.7] 40 [1.7] 40 [1.7] 41 [1.6] 36 [1.6]
Inflammation 5 [1.4] 8 [1.4] 7 [1.3] 6 [1.5] 7 [1.9] 8 [1.6]
Metaplasia, Squamous 2 [1.0] 4 [1.5] 3 [1.7]
Mineralization 1 [2.0] 1 [2.0]
Alveolar Epithelium, Hyperplasia 14 [1.1] 17 [1.1] 12 [1.2] 20 [1.2] 8 [1.1] 3 [1.0]
Alveolar Epithelium, Metaplasia, Bronchiolar 5 [1.0] 6 [1.0] 5 [1.2] 9 [1.3] 23 [1.6] 28 [1.5]
Alveolus, Metaplasia, Squamous 1 [1.0]
Nose (53) (53) (53) (53) (53) (53)
Inflammation 8 [1.1] 3 [1.3] 8 [1.1] 11 [1.2] 7 [1.1] 6 [1.3]
Mineralization 1 [1.0]
Olfactory Epithelium, Metaplasia 1 [2.0]
Respiratory Epithelium, Hyperplasia 1 [2.0] 1 [1.0] 2 [1.5] 1 [2.0] 6 [2.0] 3 [2.0]
Respiratory Epithelium, Metaplasia 1 [2.0]
Septum, Inflammation 1 [1.0] 2 [1.0] 3 [1.0] 2 [1.0] 5 [1.4] 3 [1.7]
Squamous Epithelium, Hyperplasia 1 [1.0] 1 [2.0] 1 [1.0]
Trachea (53) (53) (52) (53) (53) (53)
Inflammation 1 [3.0] 1 [2.0]
Artery, Peritracheal Tissue, Inflammation,
Chronic Active 1 [3.0]
Peritracheal Tissue, Inflammation 1 [3.0] 2 [3.0] 1 [3.0]
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (53) (53) (52) (53) (52) (52)
Hemorrhage 1 [3.0]
Inflammation 1 [3.0] 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 8
NTP Experiment-Test: 96007-05 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(PECDF) Time: 12:03:03
____________________________________________________________________________________________________________________________________
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 [2.0]
Lens, Degeneration 1 [3.0]
Retina, Atrophy 1 [2.0]
Retina, Degeneration 1 [3.0]
Harderian Gland (53) (53) (53) (53) (52) (52)
Inflammation 16 [1.0] 9 [1.0] 10 [1.0] 13 [1.1] 8 [1.1] 6 [1.0]
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (53) (53) (53) (52) (53) (53)
Accumulation, Hyaline Droplet 1 [1.0]
Calculus Micro Observation Only 5 2 4 1 2 3
Cyst 1 [2.0] 2 [2.0] 1 [2.0]
Fibrosis 1 [3.0]
Hemorrhage 1 [2.0]
Inflammation, Chronic Active 1 [3.0] 1 [1.0]
Inflammation, Suppurative 2 [1.0] 1 [1.0] 1 [1.0] 3 [1.0] 2 [1.0] 2 [1.5]
Mineralization 37 [1.0] 45 [1.0] 42 [1.0] 43 [1.1] 43 [1.0] 31 [1.1]
Necrosis 2 [2.5]
Nephropathy 34 [1.1] 39 [1.2] 35 [1.2] 42 [1.4] 36 [1.4] 45 [1.5]
Pigmentation 2 [2.0]
Artery, Inflammation, Chronic Active 1 [3.0] 1 [2.0]
Capsule, Hemorrhage 1 [3.0]
Pelvis, Dilatation 1 [3.0] 2 [2.0] 1 [3.0]
Pelvis, Inflammation 1 [2.0] 1 [2.0] 5 [2.0] 1 [2.0]
Renal Tubule, Dilatation 1 [2.0]
Renal Tubule, Hyperplasia 1 [1.0]
Renal Tubule, Necrosis 1 [2.0]
Renal Tubule, Nephropathy 1 [1.0]
Transitional Epithelium, Hyperplasia 2 [1.0] 2 [1.5] 1 [1.0] 2 [1.0] 6 [2.7] 5 [2.0]
Urinary Bladder (53) (52) (53) (53) (51) (53)
Infiltration Cellular, Lymphoid 1 [3.0]
Inflammation 2 [2.5] 3 [1.7] 1 [2.0] 1 [1.0] 6 [1.5] 1 [2.0]
Transitional Epithelium, Hyperplasia 1 [2.0] 4 [2.5] 4 [1.5]
Transitional Epithelium, Metaplasia, Squamous 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 9
NTP Experiment-Test: 96007-05 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(PECDF) Time: 12:03:03
____________________________________________________________________________________________________________________________________
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
Liver (50)
Angiectasis 1 [2.0]
Basophilic Focus 9
Basophilic Focus, Multiple 4
Cholangiofibrosis 3 [2.7]
Clear Cell Focus 4
Clear Cell Focus, Multiple 2
Degeneration, Cystic 1 [2.0]
Eosinophilic Focus 8
Eosinophilic Focus, Multiple 14
Fatty Change, Diffuse 6 [1.2]
Fatty Change, Focal 7 [1.1]
Hematopoietic Cell Proliferation 31 [1.1]
Hepatodiaphragmatic Nodule 1
Inflammation 48 [1.1]
Mixed Cell Focus 5
Mixed Cell Focus, Multiple 19
Necrosis 11 [2.1]
Pigmentation 48 [1.6]
Toxic Hepatopathy 9 [1.0]
Bile Duct, Cyst 2 [2.0]
Bile Duct, Fibrosis 1 [1.0]
Bile Duct, Hyperplasia 1 [2.0]
Centrilobular, Degeneration 7 [2.4]
Hepatocyte, Hypertrophy 14 [1.0]
Hepatocyte, Multinucleated 25 [1.2]
Oval Cell, Hyperplasia 3 [1.0]
Mesentery (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 10
NTP Experiment-Test: 96007-05 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(PECDF) Time: 12:03:03
____________________________________________________________________________________________________________________________________
SPRAGUE-DAWLEY RATS FEMALE 200 NG/
KG STOP
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Inflammation, Chronic Active 1 [3.0]
Necrosis 1 [3.0]
Oral Mucosa (50)
Gingival, Hyperplasia, Squamous 14 [1.2]
Pancreas (49)
Acinus, Vacuolization Cytoplasmic 2 [1.0]
Artery, Inflammation, Chronic Active 1 [2.0]
Stomach, Forestomach (50)
Erosion 1 [2.0]
Hyperkeratosis 1 [2.0]
Hyperplasia, Squamous 5 [2.2]
Inflammation 1 [3.0]
Ulcer 1 [2.0]
Stomach, Glandular (50)
Mineralization 3 [1.3]
Tooth (24)
Peridontal Tissue, Inflammation 24 [1.2]
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (50)
Cardiomyopathy 13 [1.1]
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (48)
Angiectasis 29 [1.4]
Degeneration, Cystic 12 [1.8]
Hyperplasia 7 [2.3]
Hypertrophy 36 [2.1]
Necrosis 3 [2.3]
Vacuolization Cytoplasmic 10 [1.3]
Bilateral, Inflammation, Chronic Active 1 [3.0]
Adrenal Medulla (48)
Hyperplasia 7 [1.9]
Parathyroid Gland (47)
Fibrosis 1 [3.0]
Pituitary Gland (49)
Angiectasis 13 [2.3]
Cyst 1 [3.0]
Cytoplasmic Alteration 2 [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 11
NTP Experiment-Test: 96007-05 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(PECDF) Time: 12:03:03
____________________________________________________________________________________________________________________________________
SPRAGUE-DAWLEY RATS FEMALE 200 NG/
KG STOP
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM - CONT
Vacuolization Cytoplasmic 2 [1.5]
Pars Distalis, Hyperplasia 19 [2.6]
Thyroid Gland (48)
C-Cell, Hyperplasia 15 [1.7]
Follicular Cell, Hypertrophy 23 [1.3]
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Clitoral Gland (50)
Inflammation 48 [1.8]
Duct, Cyst 39 [2.3]
Ovary (47)
Atrophy 39 [4.0]
Cyst 12 [2.3]
Uterus (49)
Congestion 1 [2.0]
Hemorrhage 1 [2.0]
Inflammation, Chronic Active 7 [1.9]
Inflammation, Suppurative 3 [1.3]
Metaplasia, Squamous 28 [2.1]
Endometrium, Hyperplasia, Cystic 35 [2.5]
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (50)
Hyperplasia 43 [3.0]
Lymph Node (3)
Iliac, Ectasia 1 [3.0]
Iliac, Hyperplasia, Plasma Cell 1 [3.0]
Lumbar, Ectasia 1 [2.0]
Lumbar, Hyperplasia, Plasma Cell 1 [3.0]
Renal, Ectasia 1 [2.0]
Renal, Hyperplasia, Plasma Cell 1 [2.0]
Lymph Node, Mandibular (49)
Ectasia 1 [2.0]
Hyperplasia, Lymphoid 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: 96007-05 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(PECDF) Time: 12:03:03
____________________________________________________________________________________________________________________________________
SPRAGUE-DAWLEY RATS FEMALE 200 NG/
KG STOP
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - CONT
Hyperplasia, Plasma Cell 29 [2.0]
Spleen (49)
Hematopoietic Cell Proliferation 49 [2.2]
Pigmentation 48 [1.7]
Lymphoid Follicle, Atrophy 2 [2.0]
Thymus (49)
Atrophy 44 [2.9]
Hemorrhage 1 [3.0]
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (50)
Cyst 3 [2.3]
Hyperplasia 19 [1.4]
Inflammation 1 [3.0]
Inflammation, Granulomatous 1 [2.0]
Skin (50)
Hyperkeratosis 1 [1.0]
Lip, Inflammation, Chronic Active 1 [4.0]
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (50)
Osteopetrosis 1 [2.0]
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (49)
Mineralization 1 [1.0]
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50)
Congestion 1 [3.0]
Hemorrhage 2 [2.0]
Infiltration Cellular, Histiocyte 30 [1.4]
Inflammation 5 [1.6]
Metaplasia, Squamous 1 [3.0]
Mineralization 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 13
NTP Experiment-Test: 96007-05 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(PECDF) Time: 12:03:03
____________________________________________________________________________________________________________________________________
SPRAGUE-DAWLEY RATS FEMALE 200 NG/
KG STOP
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM - CONT
Alveolar Epithelium, Hyperplasia 6 [1.0]
Alveolar Epithelium, Metaplasia, Bronchiolar 7 [1.1]
Nose (50)
Inflammation 7 [1.0]
Nasolacrimal Duct, Inflammation 1 [3.0]
Respiratory Epithelium, Hyperplasia 2 [2.0]
Trachea (50)
Inflammation 1 [2.0]
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (49)
Retina, Atrophy 1 [2.0]
Harderian Gland (49)
Inflammation 6 [1.3]
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (48)
Accumulation, Hyaline Droplet 3 [2.0]
Calculus Micro Observation Only 1
Infarct 1 [3.0]
Inflammation 1 [4.0]
Inflammation, Suppurative 2 [1.0]
Mineralization 41 [1.0]
Nephropathy 35 [1.1]
Pelvis, Dilatation 1 [3.0]
Pelvis, Inflammation 1 [2.0]
Transitional Epithelium, Hyperplasia 3 [1.7]
Urinary Bladder (50)
Inflammation 2 [3.0]
Transitional Epithelium, Hyperplasia 3 [1.7]
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
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