Incidence Rates Of Nonneoplastic Lesions By Anatomic Site
NTP Experiment-Test: 91014-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC OLEIC ACID DIETHANOLAMINE CONDENSATE Date: 11/25/97
Route: SKIN APPLICATION Time: 07:36:55
CORE STUDY
Facility: Battelle Columbus Laboratory
Chemical CAS #: 93-83-4
Lock Date: 01/02/96
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: 91014-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC OLEIC ACID DIETHANOLAMINE CONDENSATE Date: 11/25/97
Route: SKIN APPLICATION Time: 07:36:55
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 MG/KG 50 MG/KG 100MG/KG
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 50 50 50
Early Deaths
Natural Death 24 23 31
Moribund Sacrifice 11 9 5
Survivors
Terminal Sacrifice 15 18 14
Animals Examined Microscopically 50 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Esophagus (49) (50) (50)
Foreign Body 1 (2%)
Perforation 1 (2%)
Intestine Large, Colon (47) (50) (48)
Parasite Metazoan 2 (4%) 3 (6%) 4 (8%)
Intestine Large, Rectum (38) (47) (46)
Parasite Metazoan 1 (3%) 1 (2%) 2 (4%)
Intestine Small, Jejunum (36) (38) (38)
Inflammation, Chronic Active 1 (3%)
Necrosis 1 (3%)
Liver (50) (50) (50)
Angiectasis 1 (2%)
Basophilic Focus 18 (36%) 15 (30%) 11 (22%)
Clear Cell Focus 1 (2%)
Eosinophilic Focus 3 (6%)
Hepatodiaphragmatic Nodule 7 (14%) 14 (28%) 11 (22%)
Hyperplasia 1 (2%)
Inflammation, Chronic Active 13 (26%) 7 (14%) 9 (18%)
Mixed Cell Focus 1 (2%) 2 (4%)
Necrosis 1 (2%)
Vacuolization Cytoplasmic 3 (6%) 3 (6%) 2 (4%)
Bile Duct, Dilatation 1 (2%)
Mesentery (3) (3)
Fat, Inflammation, Chronic Active 3 (100%) 3 (100%)
Pancreas (50) (50) (50)
Fibrosis 1 (2%)
Acinus, Atrophy 3 (6%) 5 (10%) 1 (2%)
Stomach, Forestomach (50) (50) (50)
Hyperkeratosis 1 (2%) 1 (2%) 1 (2%)
Inflammation, Chronic Active 1 (2%) 1 (2%) 1 (2%)
Inflammation, Suppurative 1 (2%)
Ulcer 1 (2%) 5 (10%) 2 (4%)
Epithelium, Hyperplasia 1 (2%) 1 (2%) 1 (2%)
Stomach, Glandular (50) (50) (50)
a Number of animals examined microscopically at site and number of animals with lesion
Page 2
NTP Experiment-Test: 91014-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC OLEIC ACID DIETHANOLAMINE CONDENSATE Date: 11/25/97
Route: SKIN APPLICATION Time: 07:36:55
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 MG/KG 50 MG/KG 100MG/KG
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Mineralization 1 (2%)
Necrosis 1 (2%)
Ulcer 1 (2%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (50) (50) (50)
Fibrosis 1 (2%)
Inflammation, Chronic Active 18 (36%) 20 (40%) 14 (28%)
Thrombosis 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (50) (50) (50)
Accessory Adrenal Cortical Nodule 2 (4%)
Angiectasis 25 (50%) 19 (38%) 26 (52%)
Degeneration 1 (2%) 1 (2%)
Fibrosis 1 (2%)
Hematopoietic Cell Proliferation 1 (2%)
Hemorrhage 1 (2%) 1 (2%) 2 (4%)
Mineralization 1 (2%)
Pigmentation, Lipofuscin 1 (2%)
Vacuolization Cytoplasmic 7 (14%) 7 (14%) 4 (8%)
Islets, Pancreatic (50) (50) (50)
Vacuolization Cytoplasmic 1 (2%)
Parathyroid Gland (42) (43) (42)
Hyperplasia 1 (2%)
Pituitary Gland (50) (50) (50)
Angiectasis 3 (6%) 2 (4%) 4 (8%)
Cyst 8 (16%) 6 (12%) 5 (10%)
Hemorrhage 1 (2%) 1 (2%)
Pars Distalis, Angiectasis 8 (16%) 2 (4%) 4 (8%)
Pars Distalis, Hyperplasia 4 (8%) 4 (8%) 9 (18%)
Thyroid Gland (50) (50) (50)
Atrophy 1 (2%)
Ultimobranchial Cyst 2 (4%) 1 (2%)
C-Cell, Hyperplasia 1 (2%) 1 (2%)
Follicle, Cyst 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 3
NTP Experiment-Test: 91014-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC OLEIC ACID DIETHANOLAMINE CONDENSATE Date: 11/25/97
Route: SKIN APPLICATION Time: 07:36:55
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 MG/KG 50 MG/KG 100MG/KG
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Clitoral Gland (49) (47) (50)
Cyst 2 (4%) 2 (4%) 1 (2%)
Hyperplasia 1 (2%)
Inflammation, Chronic Active 46 (94%) 44 (94%) 43 (86%)
Ovary (50) (50) (50)
Atrophy 1 (2%)
Congestion 1 (2%)
Cyst 3 (6%)
Pigmentation, Lipofuscin 1 (2%)
Follicle, Cyst 1 (2%)
Periovarian Tissue, Cyst 3 (6%) 8 (16%) 3 (6%)
Oviduct (1)
Cyst 1 (100%)
Uterus (50) (50) (50)
Hemorrhage 1 (2%)
Hydrometra 4 (8%) 2 (4%)
Vagina (1) (1)
Hypertrophy 1 (100%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (50) (50) (50)
Myelofibrosis 1 (2%)
Lymph Node (2) (2) (1)
Ectasia 1 (50%)
Pigmentation, Hemosiderin 1 (50%)
Pigmentation, Lipofuscin 1 (50%)
Lymph Node, Mesenteric (50) (50) (50)
Ectasia 1 (2%) 1 (2%)
Necrosis 1 (2%)
Spleen (50) (50) (50)
Accessory Spleen 1 (2%) 1 (2%)
Fibrosis 3 (6%)
Hematopoietic Cell Proliferation 1 (2%) 1 (2%)
Necrosis 1 (2%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (49) (49) (50)
Dilatation 9 (18%) 11 (22%) 7 (14%)
Galactocele 1 (2%) 2 (4%) 1 (2%)
Inflammation, Chronic Active 1 (2%)
Skin (50) (50) (50)
Sebaceous Gland, Skin, Site of Application,
a Number of animals examined microscopically at site and number of animals with lesion
Page 4
NTP Experiment-Test: 91014-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC OLEIC ACID DIETHANOLAMINE CONDENSATE Date: 11/25/97
Route: SKIN APPLICATION Time: 07:36:55
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 MG/KG 50 MG/KG 100MG/KG
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM - CONT
Hyperplasia 2 (4%) 48 (96%) 49 (98%)
Skin, Site of Application, Hyperkeratosis 1 (2%) 38 (76%) 31 (62%)
Skin, Site of Application, Hyperplasia 3 (6%) 50 (100%) 50 (100%)
Skin, Site of Application, Inflammation,
Chronic Active 2 (4%) 44 (88%) 48 (96%)
Skin, Site of Application, Parakeratosis 2 (4%) 27 (54%) 43 (86%)
Skin, Site of Application, Ulcer 3 (6%) 20 (40%) 36 (72%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (50) (50) (50)
Fibrous Osteodystrophy 1 (2%)
Osteosclerosis 5 (10%) 1 (2%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
None
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (50) (50)
Congestion 2 (4%) 2 (4%)
Edema 1 (2%)
Inflammation, Chronic Active 5 (10%) 3 (6%) 4 (8%)
Mineralization 1 (2%)
Necrosis 1 (2%)
Pigmentation, Hemosiderin 1 (2%) 1 (2%)
Nose (49) (50) (50)
Inflammation, Suppurative 2 (4%) 2 (4%) 1 (2%)
Trachea (50) (50) (50)
Inflammation, Chronic Active 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (3) (3) (6)
Mineralization 1 (33%) 1 (33%) 1 (17%)
Retinal Detachment 1 (33%)
Lens, Cataract 1 (17%)
Lens, Mineralization 1 (33%) 3 (50%)
Retina, Degeneration 2 (67%) 3 (100%) 4 (67%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 5
NTP Experiment-Test: 91014-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC OLEIC ACID DIETHANOLAMINE CONDENSATE Date: 11/25/97
Route: SKIN APPLICATION Time: 07:36:55
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 MG/KG 50 MG/KG 100MG/KG
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (50) (50)
Casts Protein 1 (2%)
Cyst 1 (2%)
Mineralization 35 (70%) 37 (74%) 37 (74%)
Nephropathy 9 (18%) 8 (16%) 5 (10%)
Pigmentation, Hemosiderin 4 (8%) 3 (6%)
Renal Tubule, Degeneration 1 (2%)
Renal Tubule, Hyperplasia 2 (4%) 1 (2%)
Renal Tubule, Regeneration 1 (2%) 2 (4%) 2 (4%)
Urinary Bladder (50) (49) (49)
Inflammation, Chronic Active 1 (2%) 2 (4%)
Mineralization 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 6
NTP Experiment-Test: 91014-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC OLEIC ACID DIETHANOLAMINE CONDENSATE Date: 11/25/97
Route: SKIN APPLICATION Time: 07:36:55
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 MG/KG 50 MG/KG 100MG/KG
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 50 50 50
Early Deaths
Natural Death 16 10 12
Moribund Sacrifice 26 30 24
Survivors
Terminal Sacrifice 8 10 14
Animals Examined Microscopically 50 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Intestine Large, Colon (49) (48) (49)
Mineralization 3 (6%) 2 (4%)
Parasite Metazoan 3 (6%) 1 (2%) 2 (4%)
Intestine Large, Rectum (48) (49) (48)
Mineralization 1 (2%) 1 (2%)
Parasite Metazoan 2 (4%) 2 (4%)
Intestine Large, Cecum (38) (41) (40)
Mineralization 1 (3%)
Intestine Small, Duodenum (50) (50) (50)
Inflammation, Chronic Active 1 (2%)
Mineralization 2 (4%) 2 (4%)
Ulcer 2 (4%)
Intestine Small, Jejunum (42) (45) (43)
Inflammation, Chronic Active 1 (2%) 1 (2%)
Mineralization 1 (2%)
Ulcer 1 (2%)
Intestine Small, Ileum (41) (45) (45)
Parasite Metazoan 1 (2%)
Ulcer 1 (2%)
Liver (50) (50) (50)
Angiectasis 2 (4%) 2 (4%) 1 (2%)
Basophilic Focus 7 (14%) 11 (22%) 7 (14%)
Clear Cell Focus 2 (4%) 1 (2%)
Congestion 1 (2%)
Degeneration 2 (4%)
Eosinophilic Focus 1 (2%)
Hepatodiaphragmatic Nodule 4 (8%) 7 (14%) 5 (10%)
Inflammation, Chronic Active 2 (4%) 4 (8%) 2 (4%)
Mixed Cell Focus 3 (6%) 3 (6%) 5 (10%)
Necrosis 2 (4%) 2 (4%)
Vacuolization Cytoplasmic 10 (20%) 12 (24%) 15 (30%)
Bile Duct, Hyperplasia 3 (6%) 4 (8%) 2 (4%)
Mesentery (5) (7) (3)
Mineralization 1 (20%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 7
NTP Experiment-Test: 91014-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC OLEIC ACID DIETHANOLAMINE CONDENSATE Date: 11/25/97
Route: SKIN APPLICATION Time: 07:36:55
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 MG/KG 50 MG/KG 100MG/KG
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Fat, Inflammation, Chronic Active 4 (80%) 5 (71%) 2 (67%)
Fat, Mineralization 2 (29%)
Fat, Necrosis 1 (14%) 1 (33%)
Pancreas (50) (50) (50)
Acinus, Atrophy 3 (6%) 6 (12%) 3 (6%)
Acinus, Hyperplasia 1 (2%)
Duct, Hyperplasia 1 (2%)
Stomach, Forestomach (50) (50) (50)
Edema 5 (10%) 6 (12%) 3 (6%)
Hyperkeratosis 14 (28%) 26 (52%) 11 (22%)
Hyperplasia, Basal Cell 2 (4%) 1 (2%) 2 (4%)
Inflammation, Chronic Active 12 (24%) 23 (46%) 11 (22%)
Inflammation, Suppurative 3 (6%) 3 (6%) 1 (2%)
Mineralization 2 (4%) 1 (2%) 3 (6%)
Necrosis 2 (4%)
Perforation 4 (8%) 10 (20%) 1 (2%)
Ulcer 10 (20%) 14 (28%) 7 (14%)
Epithelium, Hyperplasia 14 (28%) 25 (50%) 13 (26%)
Stomach, Glandular (50) (49) (50)
Erosion 1 (2%)
Inflammation, Chronic Active 1 (2%)
Mineralization 13 (26%) 6 (12%) 8 (16%)
Necrosis 1 (2%)
Perforation 1 (2%)
Ulcer 2 (4%) 1 (2%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Blood Vessel (50) (50) (50)
Mineralization 12 (24%) 5 (10%) 7 (14%)
Heart (50) (49) (50)
Inflammation, Chronic Active 35 (70%) 38 (78%) 33 (66%)
Mineralization 7 (14%) 4 (8%) 7 (14%)
Thrombosis 1 (2%) 4 (8%) 1 (2%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (50) (50) (50)
Accessory Adrenal Cortical Nodule 1 (2%)
Angiectasis 1 (2%) 2 (4%) 2 (4%)
Degeneration 1 (2%)
Hemorrhage 1 (2%)
Hyperplasia 4 (8%) 1 (2%)
Vacuolization Cytoplasmic 11 (22%) 23 (46%) 13 (26%)
Adrenal Medulla (50) (50) (49)
a Number of animals examined microscopically at site and number of animals with lesion
Page 8
NTP Experiment-Test: 91014-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC OLEIC ACID DIETHANOLAMINE CONDENSATE Date: 11/25/97
Route: SKIN APPLICATION Time: 07:36:55
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 MG/KG 50 MG/KG 100MG/KG
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM - CONT
Hyperplasia 2 (4%) 3 (6%) 5 (10%)
Mineralization 1 (2%)
Islets, Pancreatic (50) (50) (50)
Hyperplasia 1 (2%)
Parathyroid Gland (45) (47) (50)
Hyperplasia 17 (38%) 18 (38%) 12 (24%)
Pituitary Gland (50) (50) (49)
Cyst 1 (2%) 2 (4%) 2 (4%)
Fibrosis 1 (2%)
Hemorrhage 2 (4%)
Hyperplasia 2 (4%) 1 (2%)
Mineralization 1 (2%) 2 (4%) 1 (2%)
Pars Distalis, Angiectasis 2 (4%)
Pars Distalis, Hyperplasia 2 (4%) 1 (2%) 1 (2%)
Thyroid Gland (50) (50) (50)
Atrophy 1 (2%)
Ultimobranchial Cyst 1 (2%) 1 (2%)
C-Cell, Hyperplasia 1 (2%) 1 (2%)
Follicle, Cyst 3 (6%) 1 (2%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Preputial Gland (50) (50) (50)
Cyst 8 (16%) 2 (4%) 1 (2%)
Hyperplasia 1 (2%)
Inflammation 1 (2%)
Inflammation, Chronic Active 32 (64%) 35 (70%) 38 (76%)
Mineralization 1 (2%) 1 (2%)
Prostate (50) (50) (50)
Cyst 1 (2%) 1 (2%)
Hyperplasia 1 (2%)
Inflammation, Chronic Active 10 (20%) 10 (20%) 7 (14%)
Inflammation, Suppurative 1 (2%) 3 (6%)
Mineralization 1 (2%)
Seminal Vesicle (50) (50) (50)
Inflammation, Chronic Active 1 (2%) 2 (4%)
Mineralization 2 (4%)
Testes (50) (50) (50)
Cyst 1 (2%)
Degeneration 16 (32%) 14 (28%) 11 (22%)
Mineralization 4 (8%) 6 (12%) 5 (10%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 9
NTP Experiment-Test: 91014-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC OLEIC ACID DIETHANOLAMINE CONDENSATE Date: 11/25/97
Route: SKIN APPLICATION Time: 07:36:55
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 MG/KG 50 MG/KG 100MG/KG
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM - CONT
Necrosis 1 (2%)
Interstitial Cell, Hyperplasia 28 (56%) 23 (46%) 20 (40%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (50) (49) (50)
Hyperplasia 1 (2%)
Myelofibrosis 2 (4%)
Lymph Node (2)
Ectasia 1 (50%)
Lymph Node, Mandibular (49) (49) (49)
Ectasia 1 (2%)
Hyperplasia 1 (2%)
Lymph Node, Mesenteric (49) (48) (50)
Congestion 1 (2%)
Ectasia 2 (4%) 5 (10%) 5 (10%)
Hemorrhage 1 (2%)
Hyperplasia 1 (2%)
Spleen (50) (50) (50)
Congestion 1 (2%)
Depletion Cellular 1 (2%)
Fibrosis 6 (12%) 6 (12%) 5 (10%)
Hematopoietic Cell Proliferation 2 (4%) 6 (12%) 3 (6%)
Necrosis 1 (2%) 1 (2%)
Capsule, Hyperplasia 1 (2%)
Thymus (45) (42) (44)
Atrophy 1 (2%) 2 (5%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (49) (49) (49)
Dilatation 9 (18%) 16 (33%) 12 (24%)
Galactocele 6 (12%) 8 (16%) 10 (20%)
Hyperplasia 1 (2%)
Mineralization 2 (4%)
Pigmentation, Hemosiderin 1 (2%)
Skin (50) (50) (50)
Epidermis, Cyst 1 (2%)
Sebaceous Gland, Skin, Site of Application,
Hyperplasia 1 (2%) 45 (90%) 45 (90%)
Skin, Site of Application, Fibrosis 1 (2%)
Skin, Site of Application, Hyperkeratosis 44 (88%) 40 (80%)
Skin, Site of Application, Hyperplasia 49 (98%) 47 (94%)
Skin, Site of Application, Inflammation,
Chronic Active 48 (96%) 41 (82%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 10
NTP Experiment-Test: 91014-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC OLEIC ACID DIETHANOLAMINE CONDENSATE Date: 11/25/97
Route: SKIN APPLICATION Time: 07:36:55
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 MG/KG 50 MG/KG 100MG/KG
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM - CONT
Skin, Site of Application, Mineralization 1 (2%)
Skin, Site of Application, Parakeratosis 10 (20%) 11 (22%)
Skin, Site of Application, Ulcer 7 (14%) 6 (12%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (50) (49) (50)
Fibrous Osteodystrophy 9 (18%) 11 (22%) 6 (12%)
Skeletal Muscle (1)
Inflammation, Chronic Active 1 (100%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (50) (50)
Hemorrhage 1 (2%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (50) (50)
Fibrosis 2 (4%)
Hemorrhage 1 (2%)
Inflammation, Chronic Active 5 (10%) 4 (8%)
Inflammation, Granulomatous 1 (2%)
Mineralization 5 (10%) 3 (6%) 3 (6%)
Alveolar Epithelium, Hyperplasia 1 (2%) 1 (2%)
Mediastinum, Fibrosis 1 (2%)
Serosa, Fibrosis 1 (2%)
Nose (50) (50) (50)
Inflammation, Chronic Active 1 (2%) 2 (4%)
Inflammation, Suppurative 4 (8%) 3 (6%)
Trachea (50) (50) (50)
Inflammation, Chronic Active 2 (4%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (2) (1)
Degeneration 1 (50%)
Cornea, Edema 1 (50%)
Lens, Mineralization 1 (50%) 1 (100%)
Retina, Degeneration 1 (100%)
Harderian Gland (1)
Hyperplasia 1 (100%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 11
NTP Experiment-Test: 91014-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC OLEIC ACID DIETHANOLAMINE CONDENSATE Date: 11/25/97
Route: SKIN APPLICATION Time: 07:36:55
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 MG/KG 50 MG/KG 100MG/KG
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (50) (50)
Accumulation, Hyaline Droplet 1 (2%)
Casts 1 (2%)
Cyst 5 (10%) 12 (24%) 4 (8%)
Inflammation, Chronic Active 1 (2%)
Inflammation, Suppurative 1 (2%)
Mineralization 10 (20%) 5 (10%) 7 (14%)
Necrosis 1 (2%)
Nephropathy 40 (80%) 42 (84%) 40 (80%)
Pigmentation, Hemosiderin 5 (10%) 5 (10%) 8 (16%)
Renal Tubule, Degeneration 2 (4%) 1 (2%)
Renal Tubule, Hyperplasia 1 (2%) 1 (2%)
Renal Tubule, Hyperplasia, Oncocytic 1 (2%)
Renal Tubule, Necrosis 1 (2%)
Renal Tubule, Regeneration 1 (2%) 1 (2%)
Urinary Bladder (49) (50) (50)
Calculus Micro Observation Only 1 (2%)
Fibrosis 1 (2%)
Hemorrhage 3 (6%) 1 (2%) 1 (2%)
Inflammation, Chronic Active 2 (4%) 2 (4%) 1 (2%)
Mineralization 1 (2%) 1 (2%)
Ulcer 1 (2%)
Transitional Epithelium, Hyperplasia 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 12
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