TDMS Study 05162-10 Pathology Tables
NTP Experiment-Test: 05162-10 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC DIETHANOLAMINE Date: 06/11/96
Route: SKIN APPLICATION Time: 11:08:11
CORE STUDY
Facility: Battelle Columbus Laboratory
Chemical CAS #: 111-42-2
Lock Date: 06/04/93
Cage Range: All
Reasons For Removal: All
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: 05162-10 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC DIETHANOLAMINE Date: 06/11/96
Route: SKIN APPLICATION Time: 11:08:11
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 MG/KG 40 MG/KG 80 MG/KG 160
MG/KG
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 50 50 50 50
Early Deaths
Natural Death 2 9 8 14
Moribund Sacrifice 4 8 9 13
Survivors
Terminal Sacrifice 44 33 33 22
Natural Death 1
Animals Examined Microscopically 50 50 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Intestine Small, Jejunum (50) (50) (50) (49)
Peyer's Patch, Hyperplasia, Lymphoid 1 (2%)
Liver (50) (50) (50) (50)
Clear Cell Focus 2 (4%)
Eosinophilic Focus 3 (6%) 4 (8%)
Necrosis 1 (2%) 1 (2%) 1 (2%)
Syncytial Alteration 2 (4%) 17 (34%) 18 (36%)
Hepatocyte, Vacuolization Cytoplasmic 1 (2%)
Periportal, Kupffer Cell, Amyloid Deposition 1 (2%)
Mesentery (4) (5) (1) (2)
Fat, Inflammation, Chronic 3 (75%) 4 (80%) 1 (50%)
Pancreas (50) (50) (50) (49)
Inflammation, Granulomatous 1 (2%)
Acinus, Atrophy 2 (4%)
Acinus, Cytoplasmic Alteration, Focal 1 (2%)
Salivary Glands (50) (50) (50) (50)
Infiltration Cellular, Lymphocyte 1 (2%)
Duct, Cytoplasmic Alteration 1 (2%)
Stomach, Forestomach (50) (50) (50) (49)
Hyperplasia, Focal, Squamous 1 (2%) 6 (12%) 5 (10%)
Mineralization, Diffuse 1 (2%)
Stomach, Glandular (50) (50) (50) (49)
Necrosis, Focal 3 (6%)
Tooth (1)
Developmental Malformation 1 (100%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (50) (50) (50) (50)
Atrium, Thrombosis 1 (2%) 4 (8%)
Myocardium, Degeneration, Acute 1 (2%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 2
NTP Experiment-Test: 05162-10 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC DIETHANOLAMINE Date: 06/11/96
Route: SKIN APPLICATION Time: 11:08:11
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 MG/KG 40 MG/KG 80 MG/KG 160
MG/KG
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (50) (50) (50) (50)
Accessory Adrenal Cortical Nodule 1 (2%)
Amyloid Deposition 1 (2%)
Angiectasis 1 (2%) 1 (2%) 1 (2%)
Degeneration, Diffuse 1 (2%)
Hemorrhage 1 (2%) 4 (8%)
Hypertrophy, Diffuse 1 (2%)
Hypertrophy, Focal 1 (2%)
Necrosis 1 (2%)
Vacuolization Cytoplasmic, Focal 1 (2%)
Zona Reticularis, Pigmentation 1 (2%)
Islets, Pancreatic (50) (50) (50) (49)
Hyperplasia, Focal 2 (4%) 1 (2%) 2 (4%)
Pituitary Gland (50) (50) (47) (44)
Pars Distalis, Cyst 1 (2%) 1 (2%) 2 (4%)
Pars Distalis, Hemorrhage, Focal 1 (2%)
Pars Distalis, Hyperplasia 4 (8%) 4 (8%) 3 (6%) 1 (2%)
Pars Intermedia, Hyperplasia 1 (2%)
Thyroid Gland (50) (50) (50) (49)
Follicle, Cyst 1 (2%) 1 (2%)
Follicular Cell, Hyperplasia 18 (36%) 28 (56%) 32 (64%) 39 (80%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Clitoral Gland (46) (48) (46) (43)
Cyst 1 (2%)
Ovary (49) (50) (49) (49)
Atrophy 42 (86%) 35 (70%) 44 (90%) 49 (100%)
Thrombosis 1 (2%) 1 (2%) 1 (2%)
Follicle, Cyst 10 (20%) 18 (36%) 12 (24%) 10 (20%)
Periovarian Tissue, Cyst 1 (2%) 1 (2%) 1 (2%)
Periovarian Tissue, Inflammation,
Granulomatous 1 (2%)
Uterus (50) (50) (50) (50)
Angiectasis 1 (2%)
Congestion 1 (2%)
Hyperplasia 1 (2%)
Infiltration Cellular, Lymphocyte 1 (2%)
Thrombosis 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 3
NTP Experiment-Test: 05162-10 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC DIETHANOLAMINE Date: 06/11/96
Route: SKIN APPLICATION Time: 11:08:11
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 MG/KG 40 MG/KG 80 MG/KG 160
MG/KG
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM - CONT
Endometrium, Hyperplasia, Cystic 45 (90%) 44 (88%) 31 (62%) 25 (50%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (50) (50) (50) (50)
Myelofibrosis 14 (28%) 19 (38%) 11 (22%) 8 (16%)
Myeloid Cell, Hyperplasia 1 (2%) 1 (2%) 1 (2%)
Lymph Node (9) (2) (5)
Lumbar, Infiltration Cellular, Plasma Cell 1 (11%)
Mediastinal, Hyperplasia, Lymphoid 1 (11%)
Pancreatic, Inflammation, Granulomatous 1 (11%)
Lymph Node, Mandibular (46) (48) (46) (43)
Hyperplasia, Lymphoid 1 (2%)
Infiltration Cellular, Plasma Cell 1 (2%)
Necrosis 1 (2%) 3 (7%)
Lymph Node, Mesenteric (48) (48) (44) (40)
Congestion 1 (2%)
Necrosis 2 (4%) 3 (6%) 2 (5%) 7 (18%)
Spleen (50) (50) (50) (50)
Hematopoietic Cell Proliferation 24 (48%) 31 (62%) 41 (82%) 43 (86%)
Hyperplasia, Lymphoid 2 (4%) 1 (2%)
Pigmentation, Diffuse, Hemosiderin 1 (2%)
Pigmentation, Hemosiderin 1 (2%)
Lymphoid Follicle, Depletion Cellular 1 (2%)
Thymus (48) (42) (41) (36)
Atrophy 3 (6%) 6 (14%) 8 (20%) 21 (58%)
Hyperplasia, Lymphoid 1 (2%)
Necrosis 6 (14%) 3 (7%) 4 (11%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (49) (47) (47) (40)
Hyperplasia 1 (2%) 2 (4%)
Skin (50) (50) (50) (50)
Skin, Site of Application, Acanthosis 2 (4%) 1 (2%) 2 (4%)
Skin, Site of Application, Exudate 1 (2%) 1 (2%) 3 (6%)
Skin, Site of Application, Hyperkeratosis 1 (2%) 3 (6%) 8 (16%) 16 (32%)
Skin, Site of Application, Ulcer 1 (2%)
Subcutaneous Tissue, Edema, Diffuse 1 (2%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 4
NTP Experiment-Test: 05162-10 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC DIETHANOLAMINE Date: 06/11/96
Route: SKIN APPLICATION Time: 11:08:11
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 MG/KG 40 MG/KG 80 MG/KG 160
MG/KG
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Skeletal Muscle (1) (1)
Inflammation, Granulomatous 1 (100%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (50) (50) (50)
Hydrocephalus 1 (2%)
Cerebrum, Cyst Epithelial Inclusion 1 (2%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (50) (50) (50)
Inflammation, Chronic 1 (2%) 1 (2%)
Inflammation, Chronic Active 1 (2%)
Alveolar Epithelium, Hyperplasia 1 (2%) 2 (4%) 1 (2%)
Alveolus, Infiltration Cellular, Histiocyte 2 (4%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (1) (2)
Degeneration 2 (100%)
Cornea, Inflammation, Chronic Active 1 (100%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (50) (50) (50)
Metaplasia, Focal, Osseous 2 (4%)
Nephropathy 25 (50%) 24 (48%) 16 (32%) 17 (34%)
Cortex, Cyst 1 (2%) 1 (2%)
Cortex, Infarct 1 (2%) 2 (4%)
Glomerulus, Amyloid Deposition 1 (2%)
Renal Tubule, Dilatation 1 (2%)
Renal Tubule, Mineralization 4 (8%) 3 (6%)
Renal Tubule, Pigmentation 1 (2%)
Urinary Bladder (50) (49) (50) (48)
Infiltration Cellular, Lymphocyte 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 5
NTP Experiment-Test: 05162-10 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC DIETHANOLAMINE Date: 06/11/96
Route: SKIN APPLICATION Time: 11:08:11
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 MG/KG 40 MG/KG 80 MG/KG 160
MG/KG
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 50 50 50 50
Early Deaths
Natural Death 7 6 10 9
Moribund Sacrifice 3 1 6 10
Accidently Killed 1
Survivors
Terminal Sacrifice 40 41 34 30
Natural Death 2
Animals Examined Microscopically 50 50 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Intestine Large, Cecum (50) (49) (50) (50)
Lymphoid Tissue, Hyperplasia, Lymphoid 1 (2%)
Lymphoid Tissue, Inflammation, Chronic Active 1 (2%)
Intestine Small, Duodenum (50) (49) (49) (50)
Peyer's Patch, Hyperplasia, Lymphoid 1 (2%)
Liver (50) (50) (50) (50)
Basophilic Focus 2 (4%) 1 (2%)
Clear Cell Focus 4 (8%) 7 (14%) 2 (4%) 2 (4%)
Clear Cell Focus, Multiple 1 (2%)
Eosinophilic Focus 3 (6%) 4 (8%) 2 (4%) 4 (8%)
Eosinophilic Focus, Multiple 1 (2%)
Hematopoietic Cell Proliferation 1 (2%)
Hematopoietic Cell Proliferation, Diffuse 1 (2%)
Hepatodiaphragmatic Nodule 1 (2%) 1 (2%)
Inflammation, Suppurative 1 (2%)
Necrosis 2 (4%)
Syncytial Alteration 28 (56%) 38 (76%) 23 (46%)
Thrombosis 1 (2%) 1 (2%)
Centrilobular, Cytoplasmic Alteration 1 (2%) 17 (34%) 17 (34%) 12 (24%)
Mesentery (1)
Fat, Inflammation, Chronic 1 (100%)
Pancreas (50) (50) (50) (50)
Inflammation, Chronic Active 1 (2%)
Acinus, Atrophy 2 (4%) 2 (4%) 1 (2%)
Acinus, Cytoplasmic Alteration 1 (2%) 1 (2%) 3 (6%)
Salivary Glands (50) (50) (50) (50)
Duct, Cytoplasmic Alteration 1 (2%) 2 (4%) 8 (16%) 23 (46%)
Stomach, Forestomach (50) (49) (50) (50)
Hyperplasia, Focal, Squamous 1 (2%) 4 (8%) 4 (8%) 2 (4%)
Stomach, Glandular (50) (49) (50) (50)
Necrosis 1 (2%) 1 (2%)
Pigmentation 3 (6%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 6
NTP Experiment-Test: 05162-10 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC DIETHANOLAMINE Date: 06/11/96
Route: SKIN APPLICATION Time: 11:08:11
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 MG/KG 40 MG/KG 80 MG/KG 160
MG/KG
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Epithelium, Hyperplasia, Focal 1 (2%) 2 (4%)
Tooth (3) (2)
Developmental Malformation 1 (33%) 2 (100%)
Peridontal Tissue, Inflammation, Chronic
Active 2 (67%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Blood Vessel (50) (50) (50) (49)
Adventitia, Inflammation, Chronic 1 (2%)
Heart (50) (50) (50) (50)
Atrium, Thrombosis 6 (12%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (50) (50) (50) (50)
Hyperplasia, Focal 1 (2%) 3 (6%)
Hypertrophy, Diffuse 1 (2%)
Hypertrophy, Focal 6 (12%) 8 (16%) 4 (8%) 7 (14%)
Vacuolization Cytoplasmic, Focal 1 (2%)
Capsule, Hyperplasia 2 (4%) 6 (12%) 5 (10%) 3 (6%)
Islets, Pancreatic (50) (50) (50) (50)
Hyperplasia 2 (4%)
Parathyroid Gland (41) (41) (41) (43)
Cyst 1 (2%)
Pituitary Gland (48) (47) (46) (43)
Craniopharyngeal Duct, Pars Distalis, Cyst 1 (2%)
Pars Distalis, Cyst 2 (4%) 1 (2%) 1 (2%) 3 (7%)
Pars Distalis, Hyperplasia 2 (4%)
Thyroid Gland (50) (49) (50) (50)
Follicular Cell, Hyperplasia 18 (36%) 22 (45%) 30 (60%) 42 (84%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
Tissue NOS (1)
Pelvic, Abscess 1 (100%)
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Epididymis (50) (50) (50) (50)
Granuloma Sperm 1 (2%)
Preputial Gland (50) (50) (50) (49)
Cyst 16 (32%) 12 (24%) 20 (40%) 12 (24%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 7
NTP Experiment-Test: 05162-10 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC DIETHANOLAMINE Date: 06/11/96
Route: SKIN APPLICATION Time: 11:08:11
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 MG/KG 40 MG/KG 80 MG/KG 160
MG/KG
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM - CONT
Inflammation, Chronic Active 3 (6%) 5 (10%) 1 (2%) 3 (6%)
Prostate (50) (50) (50) (50)
Inflammation, Chronic Active 1 (2%)
Inflammation, Diffuse, Suppurative 1 (2%)
Seminal Vesicle (50) (50) (50) (50)
Inflammation, Diffuse, Suppurative 1 (2%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (50) (50) (50) (50)
Myeloid Cell, Depletion Cellular 1 (2%)
Lymph Node (1) (2) (1)
Hyperplasia, Lymphoid 1 (50%)
Lymph Node, Mandibular (46) (46) (44) (36)
Necrosis 3 (7%) 2 (5%) 2 (6%)
Lymph Node, Mesenteric (45) (43) (41) (41)
Angiectasis 1 (2%)
Congestion 2 (4%) 1 (2%)
Inflammation, Suppurative 1 (2%)
Necrosis 4 (9%) 1 (2%) 6 (15%)
Spleen (50) (50) (50) (50)
Hematopoietic Cell Proliferation 13 (26%) 22 (44%) 29 (58%) 32 (64%)
Hyperplasia, Lymphoid 1 (2%)
Thrombosis 1 (2%)
Lymphoid Follicle, Necrosis 1 (2%)
Red Pulp, Depletion Cellular 1 (2%)
Thymus (37) (42) (39) (36)
Atrophy 8 (22%) 8 (19%) 18 (46%) 17 (47%)
Cyst 1 (2%)
Necrosis 2 (5%) 1 (2%) 3 (8%) 2 (6%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Skin (50) (50) (50) (50)
Hyperkeratosis 1 (2%)
Dermis, Fibrosis 1 (2%)
Skin, Site of Application, Acanthosis 2 (4%) 4 (8%)
Skin, Site of Application, Exudate 3 (6%)
Skin, Site of Application, Hyperkeratosis 13 (26%) 10 (20%) 17 (34%)
Skin, Site of Application, Inflammation,
Chronic 1 (2%)
Skin, Site of Application, Ulcer 1 (2%) 1 (2%)
Subcutaneous Tissue, Angiectasis 1 (2%)
Subcutaneous Tissue, Edema 1 (2%)
Subcutaneous Tissue, Fibrosis 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 8
NTP Experiment-Test: 05162-10 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC DIETHANOLAMINE Date: 06/11/96
Route: SKIN APPLICATION Time: 11:08:11
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 MG/KG 40 MG/KG 80 MG/KG 160
MG/KG
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (50) (50) (50) (50)
Hyperostosis 1 (2%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (50) (50) (50)
Hemorrhage 1 (2%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (50) (50) (50)
Inflammation, Diffuse, Granulomatous 1 (2%)
Inflammation, Suppurative 1 (2%)
Alveolar Epithelium, Hyperplasia 2 (4%) 2 (4%) 2 (4%) 1 (2%)
Alveolus, Infiltration Cellular, Histiocyte 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
None
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (50) (50) (50)
Hydronephrosis 1 (2%)
Infiltration Cellular, Lymphocyte 2 (4%) 1 (2%)
Inflammation, Chronic, Diffuse 1 (2%)
Nephropathy 45 (90%) 47 (94%) 45 (90%) 48 (96%)
Cortex, Cyst 5 (10%) 2 (4%)
Cortex, Infarct 1 (2%)
Glomerulus, Dilatation, Diffuse 1 (2%) 1 (2%) 1 (2%)
Glomerulus, Dilatation, Focal 22 (44%) 39 (78%) 39 (78%) 32 (64%)
Pelvis, Inflammation, Suppurative 1 (2%)
Renal Tubule, Dilatation 1 (2%)
Renal Tubule, Hyperplasia, Focal 1 (2%) 2 (4%) 3 (6%)
Renal Tubule, Mineralization 38 (76%) 45 (90%) 38 (76%) 41 (82%)
Renal Tubule, Pigmentation, Hemosiderin 1 (2%) 2 (4%) 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 9
NTP Experiment-Test: 05162-10 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC DIETHANOLAMINE Date: 06/11/96
Route: SKIN APPLICATION Time: 11:08:11
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 MG/KG 40 MG/KG 80 MG/KG 160
MG/KG
____________________________________________________________________________________________________________________________________
URINARY SYSTEM - CONT
Renal Tubule, Vacuolization Cytoplasmic 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 10
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