Incidence Rates Of Nonneoplastic Lesions By Anatomic Site
NTP Experiment-Test: 91014-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC OLEIC ACID DIETHANOLAMINE CONDENSATE Date: 09/23/97
Route: SKIN APPLICATION Time: 09:41:16
2 YEAR CHRONIC
Facility: Battelle Columbus Laboratory
Chemical CAS #: 93-83-4
Lock Date: 01/02/96
Cage Range: All
Reasons For Removal: 25022 Accidently Killed 25023 Missing
25019 Moribund Sacrifice 25020 Natural Death
25021 Terminal Sacrifice
Removal Date Range: All
Treatment Groups: Include 002 0 MG/KG
Include 004 15 MG/KG
Include 006 30 MG/KG
Include 001 0 MG/KG
Include 003 15 MG/KG
Include 005 30 MG/KG
a Number of animals examined microscopically at site and number of animals with lesion
Page 1
NTP Experiment-Test: 91014-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC OLEIC ACID DIETHANOLAMINE CONDENSATE Date: 09/23/97
Route: SKIN APPLICATION Time: 09:41:16
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 MG/KG 15 MG/KG 30 MG/KG
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 55 55 55
Early Deaths
Moribund Sacrifice 8 12 8
Natural Death 8 8 6
Accidently Killed 1
Survivors
Terminal Sacrifice 34 30 35
Animals Examined Microscopically 50 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Intestine Small, Duodenum (49) (50) (50)
Inflammation, Suppurative 1 (2%)
Intestine Small, Jejunum (50) (49) (50)
Peyer's Patch, Hyperplasia 1 (2%)
Liver (50) (50) (50)
Angiectasis 1 (2%)
Basophilic Focus 1 (2%) 1 (2%)
Clear Cell Focus 3 (6%) 2 (4%) 3 (6%)
Cyst 1 (2%) 1 (2%)
Eosinophilic Focus 11 (22%) 5 (10%) 10 (20%)
Eosinophilic Focus, Multiple 4 (8%) 8 (16%) 4 (8%)
Infarct 1 (2%)
Mixed Cell Focus 6 (12%) 6 (12%) 6 (12%)
Mixed Cell Focus, Multiple 2 (4%) 2 (4%) 1 (2%)
Necrosis 2 (4%) 1 (2%)
Pigmentation 1 (2%)
Vacuolization Cytoplasmic 1 (2%)
Bile Duct, Cyst 1 (2%)
Mesentery (12) (7) (9)
Inflammation, Suppurative 1 (11%)
Necrosis 2 (17%) 2 (29%) 1 (11%)
Fat, Necrosis 9 (75%) 5 (71%) 5 (56%)
Pancreas (49) (50) (50)
Basophilic Focus 1 (2%)
Acinus, Atrophy 1 (2%)
Duct, Cyst 1 (2%)
Stomach, Forestomach (50) (50) (50)
Hyperkeratosis 1 (2%) 1 (2%)
Hyperplasia 3 (6%)
Stomach, Glandular (50) (50) (50)
Cyst 1 (2%)
Inflammation, Acute 1 (2%)
Mineralization 2 (4%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 2
NTP Experiment-Test: 91014-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC OLEIC ACID DIETHANOLAMINE CONDENSATE Date: 09/23/97
Route: SKIN APPLICATION Time: 09:41:16
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 MG/KG 15 MG/KG 30 MG/KG
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Blood Vessel (50) (50) (50)
Aorta, Mineralization 2 (4%)
Heart (50) (50) (50)
Degeneration 1 (2%)
Inflammation, Suppurative 1 (2%)
Mineralization 4 (8%) 1 (2%)
Thrombosis 1 (2%)
Artery, Inflammation, Chronic Active 1 (2%)
Artery, Mineralization 1 (2%)
Pericardium, Inflammation, Chronic Active 2 (4%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (50) (50) (50)
Angiectasis 1 (2%)
Hyperplasia 1 (2%) 1 (2%)
Hypertrophy 1 (2%) 1 (2%)
Zona Fasciculata, Vacuolization Cytoplasmic 1 (2%) 1 (2%)
Adrenal Medulla (50) (50) (50)
Hyperplasia 1 (2%) 2 (4%)
Islets, Pancreatic (49) (50) (50)
Hyperplasia 7 (14%) 8 (16%) 6 (12%)
Pituitary Gland (50) (50) (50)
Angiectasis 4 (8%) 1 (2%)
Hypertrophy 1 (2%)
Pars Distalis, Hyperplasia 9 (18%) 6 (12%) 7 (14%)
Thyroid Gland (50) (50) (50)
Atrophy 1 (2%)
Inflammation, Chronic Active 1 (2%)
C-Cell, Hyperplasia 1 (2%)
Follicle, Cyst 1 (2%)
Follicular Cell, Hyperplasia 14 (28%) 15 (30%) 15 (30%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 3
NTP Experiment-Test: 91014-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC OLEIC ACID DIETHANOLAMINE CONDENSATE Date: 09/23/97
Route: SKIN APPLICATION Time: 09:41:16
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 MG/KG 15 MG/KG 30 MG/KG
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Ovary (50) (50) (50)
Angiectasis 1 (2%)
Atrophy 5 (10%) 5 (10%)
Hemorrhage 1 (2%)
Follicle, Cyst 7 (14%) 11 (22%) 14 (28%)
Periovarian Tissue, Angiectasis 1 (2%)
Periovarian Tissue, Cyst 3 (6%)
Oviduct (1) (1)
Atrophy 1 (100%)
Uterus (50) (50) (50)
Angiectasis 1 (2%)
Cyst 1 (2%)
Inflammation, Acute 1 (2%)
Endometrium, Hyperplasia 9 (18%)
Endometrium, Hyperplasia, Cystic 35 (70%) 20 (40%) 28 (56%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (50) (50) (50)
Hyperplasia 3 (6%) 1 (2%) 2 (4%)
Myelofibrosis 11 (22%) 9 (18%) 8 (16%)
Lymph Node (2) (5) (8)
Lumbar, Hyperplasia, Histiocytic 1 (50%)
Renal, Angiectasis 1 (13%)
Renal, Hyperplasia, Lymphoid 1 (13%)
Lymph Node, Mandibular (49) (49) (47)
Hyperplasia 1 (2%)
Hyperplasia, Lymphoid 1 (2%) 2 (4%) 3 (6%)
Lymph Node, Mesenteric (49) (47) (49)
Hyperplasia, Lymphoid 1 (2%) 2 (4%)
Spleen (50) (50) (50)
Hematopoietic Cell Proliferation 22 (44%) 27 (54%) 15 (30%)
Hyperplasia, Lymphoid 4 (8%) 3 (6%) 5 (10%)
Thymus (41) (45) (47)
Atrophy 6 (15%) 4 (9%) 5 (11%)
Hyperplasia, Lymphoid 2 (4%) 2 (4%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (49) (50) (49)
Dilatation 1 (2%)
Hyperplasia, Cystic 1 (2%)
Inflammation, Acute 1 (2%)
Skin (50) (50) (50)
a Number of animals examined microscopically at site and number of animals with lesion
Page 4
NTP Experiment-Test: 91014-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC OLEIC ACID DIETHANOLAMINE CONDENSATE Date: 09/23/97
Route: SKIN APPLICATION Time: 09:41:16
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 MG/KG 15 MG/KG 30 MG/KG
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM - CONT
Fibrosis 1 (2%)
Dermis, Skin, Site of Application,
Inflammation, Chronic Active 40 (80%) 49 (98%)
Epidermis, Skin, Site of Application,
Hyperplasia 43 (86%) 50 (100%)
Epidermis, Skin, Site of Application,
Parakeratosis 4 (8%)
Sebaceous Gland, Skin, Site of Application,
Hyperplasia 39 (78%) 46 (92%)
Skin, Site of Application, Exudate 6 (12%)
Skin, Site of Application, Hyperkeratosis 36 (72%) 42 (84%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (50) (50) (50)
Arthrosis 1 (2%)
Fibrous Osteodystrophy 1 (2%) 2 (4%)
Femur, Fibrous Osteodystrophy 1 (2%)
Maxilla, Fibrous Osteodystrophy 1 (2%)
Vertebra, Fibrous Osteodystrophy 1 (2%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (50) (50)
Necrosis 1 (2%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (50) (50)
Hemorrhage 1 (2%)
Alveolar Epithelium, Hyperplasia 2 (4%) 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
None
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (50) (50)
Accumulation, Hyaline Droplet 3 (6%) 3 (6%) 3 (6%)
Mineralization 9 (18%) 2 (4%) 2 (4%)
Nephropathy 11 (22%) 6 (12%) 16 (32%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 5
NTP Experiment-Test: 91014-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC OLEIC ACID DIETHANOLAMINE CONDENSATE Date: 09/23/97
Route: SKIN APPLICATION Time: 09:41:16
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 MG/KG 15 MG/KG 30 MG/KG
____________________________________________________________________________________________________________________________________
URINARY SYSTEM - CONT
Pigmentation 1 (2%)
Pelvis, Dilatation 1 (2%)
Renal Tubule, Dilatation 3 (6%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 6
NTP Experiment-Test: 91014-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC OLEIC ACID DIETHANOLAMINE CONDENSATE Date: 09/23/97
Route: SKIN APPLICATION Time: 09:41:16
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 MG/KG 15 MG/KG 30 MG/KG
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 55 55 55
Early Deaths
Moribund Sacrifice 3 8 11
Natural Death 5 7 5
Survivors
Terminal Sacrifice 41 35 34
Missing 1
Animals Examined Microscopically 49 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Intestine Small, Duodenum (48) (50) (50)
Ulcer 1 (2%) 1 (2%)
Intestine Small, Jejunum (49) (50) (50)
Hyperplasia, Lymphoid 2 (4%)
Peyer's Patch, Hyperplasia, Lymphoid 1 (2%) 1 (2%)
Liver (49) (50) (50)
Basophilic Focus 4 (8%) 3 (6%) 3 (6%)
Clear Cell Focus 3 (6%) 3 (6%) 6 (12%)
Clear Cell Focus, Multiple 1 (2%) 4 (8%) 2 (4%)
Eosinophilic Focus 7 (14%) 5 (10%) 8 (16%)
Eosinophilic Focus, Multiple 5 (10%) 4 (8%) 1 (2%)
Infarct 3 (6%)
Mixed Cell Focus 3 (6%) 6 (12%) 5 (10%)
Mixed Cell Focus, Multiple 1 (2%) 9 (18%) 5 (10%)
Necrosis 7 (14%) 1 (2%) 9 (18%)
Vacuolization Cytoplasmic 1 (2%) 1 (2%) 1 (2%)
Bile Duct, Cyst 1 (2%)
Mesentery (4) (4) (3)
Necrosis, Focal 1 (33%)
Fat, Necrosis 2 (50%) 3 (75%) 2 (67%)
Pancreas (49) (50) (50)
Basophilic Focus 1 (2%)
Necrosis 1 (2%)
Duct, Cyst 1 (2%) 1 (2%)
Stomach, Forestomach (49) (50) (50)
Cyst 1 (2%) 1 (2%)
Hyperkeratosis 1 (2%)
Hyperplasia 2 (4%) 1 (2%)
Inflammation, Suppurative 1 (2%)
Ulcer 1 (2%)
Stomach, Glandular (49) (50) (50)
Cyst 3 (6%) 1 (2%)
Erosion 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 7
NTP Experiment-Test: 91014-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC OLEIC ACID DIETHANOLAMINE CONDENSATE Date: 09/23/97
Route: SKIN APPLICATION Time: 09:41:16
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 MG/KG 15 MG/KG 30 MG/KG
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Hyperplasia, Focal 1 (2%)
Inflammation, Chronic Active 1 (2%)
Mineralization 1 (2%) 2 (4%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (49) (50) (50)
Cardiomyopathy 1 (2%)
Necrosis 1 (2%)
Artery, Inflammation, Chronic Active 1 (2%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (49) (50) (50)
Hyperplasia 2 (4%) 1 (2%) 5 (10%)
Hypertrophy 22 (45%) 12 (24%) 10 (20%)
Capsule, Hyperplasia 11 (22%) 7 (14%) 7 (14%)
Adrenal Medulla (49) (50) (50)
Hyperplasia 1 (2%) 2 (4%)
Islets, Pancreatic (49) (50) (50)
Hyperplasia 30 (61%) 28 (56%) 26 (52%)
Parathyroid Gland (45) (42) (42)
Hyperplasia 1 (2%)
Pituitary Gland (49) (47) (50)
Pars Distalis, Hyperplasia 1 (2%) 1 (2%)
Thyroid Gland (49) (50) (50)
Cyst 1 (2%)
Inflammation, Chronic Active 1 (2%)
Follicle, Cyst 1 (2%)
Follicular Cell, Hyperplasia 8 (16%) 7 (14%) 9 (18%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Preputial Gland (48) (50) (50)
Angiectasis 1 (2%)
Cyst 17 (35%) 12 (24%) 10 (20%)
Inflammation 1 (2%)
Inflammation, Chronic Active 5 (10%) 1 (2%) 2 (4%)
Seminal Vesicle (49) (50) (50)
a Number of animals examined microscopically at site and number of animals with lesion
Page 8
NTP Experiment-Test: 91014-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC OLEIC ACID DIETHANOLAMINE CONDENSATE Date: 09/23/97
Route: SKIN APPLICATION Time: 09:41:16
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 MG/KG 15 MG/KG 30 MG/KG
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM - CONT
Cyst 2 (4%)
Hypertrophy 1 (2%)
Testes (49) (50) (50)
Atrophy 1 (2%) 3 (6%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (49) (50) (50)
Hyperplasia 4 (8%) 4 (8%) 6 (12%)
Myelofibrosis 3 (6%)
Lymph Node, Mandibular (48) (46) (47)
Hyperplasia, Lymphoid 1 (2%)
Lymph Node, Mesenteric (47) (48) (48)
Angiectasis 1 (2%) 2 (4%)
Ectasia 1 (2%)
Hematopoietic Cell Proliferation 1 (2%)
Hyperplasia, Lymphoid 2 (4%)
Inflammation, Chronic Active 1 (2%)
Spleen (49) (50) (50)
Angiectasis 1 (2%)
Hematopoietic Cell Proliferation 10 (20%) 12 (24%) 16 (32%)
Hyperplasia, Lymphoid 1 (2%) 2 (4%)
Inflammation, Chronic Active 1 (2%)
Thymus (45) (36) (39)
Atrophy 5 (11%) 5 (13%)
Epithelial Cell, Hyperplasia 1 (3%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Skin (49) (50) (50)
Hyperkeratosis 2 (4%)
Dermis, Skin, Site of Application,
Inflammation, Chronic Active 34 (68%) 50 (100%)
Epidermis, Skin, Site of Application,
Hyperplasia 1 (2%) 40 (80%) 47 (94%)
Epidermis, Skin, Site of Application,
Inflammation, Suppurative 3 (6%)
Epidermis, Skin, Site of Application,
Parakeratosis 2 (4%) 8 (16%)
Sebaceous Gland, Hyperplasia 1 (2%)
Sebaceous Gland, Skin, Site of Application,
Hyperplasia 1 (2%) 21 (42%) 34 (68%)
Skin, Site of Application, Exudate 1 (2%) 3 (6%) 9 (18%)
Skin, Site of Application, Hyperkeratosis 1 (2%) 38 (76%) 37 (74%)
Skin, Site of Application, Ulcer 7 (14%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 9
NTP Experiment-Test: 91014-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC OLEIC ACID DIETHANOLAMINE CONDENSATE Date: 09/23/97
Route: SKIN APPLICATION Time: 09:41:16
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 MG/KG 15 MG/KG 30 MG/KG
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM - CONT
Subcutaneous Tissue, Edema 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (49) (50) (50)
Hyperostosis 1 (2%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
None
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (49) (50) (50)
Hemorrhage 1 (2%)
Hyperplasia 3 (6%)
Alveolar Epithelium, Hyperplasia 5 (10%) 3 (6%) 8 (16%)
Nose (49) (50) (50)
Lateral Wall, Inflammation, Chronic Active 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (1)
Cornea, Degeneration 1 (100%)
Harderian Gland (2) (1) (5)
Hyperplasia 1 (20%)
Lacrimal Gland (1)
Mineralization 1 (100%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (49) (50) (50)
Accumulation, Hyaline Droplet 1 (2%)
Cyst 3 (6%) 1 (2%) 3 (6%)
Mineralization 37 (76%) 39 (78%) 28 (56%)
Nephropathy 44 (90%) 38 (76%) 38 (76%)
Pigmentation 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 10
NTP Experiment-Test: 91014-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC OLEIC ACID DIETHANOLAMINE CONDENSATE Date: 09/23/97
Route: SKIN APPLICATION Time: 09:41:16
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 MG/KG 15 MG/KG 30 MG/KG
____________________________________________________________________________________________________________________________________
URINARY SYSTEM - CONT
Vacuolization Cytoplasmic 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 11
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