TDMS Study 55312-04 Pathology Tables
NTP Experiment-Test: 55312-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC COCONUT OIL ACID DIETHANOLAMINE CONDENSATE Date: 09/18/97
Route: SKIN APPLICATION Time: 08:14:59
2 YEAR CHRONIC
Facility: Battelle Columbus Laboratory
Chemical CAS #: 68603-42-9
Lock Date: 09/06/95
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: 55312-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC COCONUT OIL ACID DIETHANOLAMINE CONDENSATE Date: 09/18/97
Route: SKIN APPLICATION Time: 08:14:59
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 MG/KG 100 200
MG/KG MG/KG
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 50 50 50
Early Deaths
Moribund Sacrifice 11 11 15
Natural Death 4 3 9
Survivors
Terminal Sacrifice 35 35 26
Natural Death 1
Animals Examined Microscopically 50 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Esophagus (50) (50) (50)
Inflammation 1 (2%)
Intestine Large, Rectum (50) (50) (50)
Hemorrhage 1 (2%)
Intestine Small, Duodenum (50) (50) (50)
Erosion 2 (4%)
Ulcer 1 (2%) 1 (2%)
Intestine Small, Jejunum (49) (50) (50)
Hyperplasia, Lymphoid 1 (2%) 2 (4%)
Inflammation 1 (2%)
Ulcer 1 (2%)
Mucosa, Hyperplasia 1 (2%)
Liver (50) (50) (50)
Angiectasis 1 (2%) 1 (2%)
Basophilic Focus 2 (4%)
Clear Cell Focus 2 (4%) 2 (4%) 2 (4%)
Eosinophilic Focus 18 (36%) 25 (50%) 24 (48%)
Fibrosis 2 (4%) 1 (2%)
Inflammation, Suppurative 1 (2%)
Mixed Cell Focus 1 (2%) 5 (10%)
Necrosis 2 (4%) 5 (10%) 8 (16%)
Bile Duct, Hyperplasia 1 (2%) 1 (2%)
Mesentery (12) (9) (8)
Fat, Inflammation 2 (17%)
Fat, Necrosis 9 (75%) 8 (89%) 7 (88%)
Pancreas (50) (50) (50)
Atrophy 1 (2%) 4 (8%) 1 (2%)
Hypertrophy 1 (2%)
Hypertrophy, Focal 3 (6%) 1 (2%) 1 (2%)
Duct, Cyst 2 (4%) 1 (2%)
Stomach, Forestomach (50) (50) (50)
Erosion 1 (2%) 1 (2%)
Hyperplasia, Focal 2 (4%) 2 (4%) 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 2
NTP Experiment-Test: 55312-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC COCONUT OIL ACID DIETHANOLAMINE CONDENSATE Date: 09/18/97
Route: SKIN APPLICATION Time: 08:14:59
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 MG/KG 100 200
MG/KG MG/KG
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Inflammation 1 (2%)
Ulcer 1 (2%)
Stomach, Glandular (50) (50) (50)
Erosion 1 (2%) 2 (4%)
Inflammation 2 (4%)
Mineralization 2 (4%) 1 (2%) 1 (2%)
Ulcer 1 (2%)
Tooth (1)
Inflammation 1 (100%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (50) (50) (50)
Infiltration Cellular, Mononuclear Cell 1 (2%)
Mineralization 1 (2%) 1 (2%) 1 (2%)
Artery, Inflammation 1 (2%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (50) (50) (50)
Hematopoietic Cell Proliferation 1 (2%)
Hyperplasia 1 (2%) 1 (2%)
Hypertrophy 1 (2%)
Vacuolization Cytoplasmic 1 (2%)
Capsule, Hyperplasia 2 (4%)
Adrenal Medulla (50) (50) (50)
Hyperplasia 2 (4%) 1 (2%) 2 (4%)
Islets, Pancreatic (50) (50) (50)
Hyperplasia 1 (2%) 2 (4%)
Parathyroid Gland (37) (42) (43)
Cyst 1 (3%)
Hyperplasia, Focal 1 (2%)
Pituitary Gland (48) (50) (49)
Angiectasis 1 (2%)
Pars Distalis, Hyperplasia 28 (58%) 31 (62%) 27 (55%)
Pars Intermedia, Hyperplasia 1 (2%) 1 (2%)
Thyroid Gland (50) (50) (50)
Follicular Cell, Hyperplasia 27 (54%) 36 (72%) 33 (66%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 3
NTP Experiment-Test: 55312-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC COCONUT OIL ACID DIETHANOLAMINE CONDENSATE Date: 09/18/97
Route: SKIN APPLICATION Time: 08:14:59
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 MG/KG 100 200
MG/KG MG/KG
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Clitoral Gland (48) (49) (47)
Inflammation 1 (2%)
Ovary (50) (50) (50)
Angiectasis 2 (4%)
Cyst 15 (30%) 14 (28%) 15 (30%)
Hemorrhage 2 (4%) 2 (4%)
Mineralization 1 (2%)
Granulosa Cell, Hyperplasia 1 (2%) 1 (2%)
Uterus (50) (50) (50)
Decidual Reaction 1 (2%)
Hyperplasia 37 (74%) 26 (52%) 22 (44%)
Inflammation, Suppurative 1 (2%)
Thrombosis 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (50) (50) (50)
Hyperplasia 7 (14%) 10 (20%) 19 (38%)
Myelofibrosis 21 (42%) 21 (42%) 19 (38%)
Lymph Node (7) (3) (6)
Inguinal, Hematopoietic Cell Proliferation 1 (17%)
Mediastinal, Hematopoietic Cell Proliferation 1 (17%)
Renal, Hematopoietic Cell Proliferation 1 (17%)
Lymph Node, Mandibular (49) (47) (49)
Hematopoietic Cell Proliferation 2 (4%)
Hyperplasia, Lymphoid 1 (2%)
Hyperplasia, Plasma Cell 1 (2%)
Lymph Node, Mesenteric (48) (50) (49)
Angiectasis 1 (2%) 2 (4%)
Hematopoietic Cell Proliferation 1 (2%) 2 (4%)
Hyperplasia, Lymphoid 1 (2%)
Hyperplasia, Plasma Cell 1 (2%)
Inflammation 1 (2%)
Spleen (50) (50) (50)
Accessory Spleen 1 (2%)
Hematopoietic Cell Proliferation 33 (66%) 33 (66%) 36 (72%)
Lymphoid Follicle, Hyperplasia 1 (2%) 5 (10%)
Thymus (47) (40) (41)
Atrophy 7 (15%) 4 (10%) 8 (20%)
Hyperplasia, Lymphoid 1 (2%) 2 (5%) 1 (2%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 4
NTP Experiment-Test: 55312-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC COCONUT OIL ACID DIETHANOLAMINE CONDENSATE Date: 09/18/97
Route: SKIN APPLICATION Time: 08:14:59
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 MG/KG 100 200
MG/KG MG/KG
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Skin (50) (50) (50)
Control, Edema 1 (2%)
Control, Hyperkeratosis 1 (2%)
Control, Inflammation 3 (6%)
Control, Parakeratosis 1 (2%)
Epidermis, Control, Hyperplasia 1 (2%)
Epidermis, Skin, Site of Application,
Hyperplasia 9 (18%) 47 (94%) 50 (100%)
Sebaceous Gland, Skin, Site of Application,
Hyperplasia 42 (84%) 48 (96%)
Skin, Site of Application, Hyperkeratosis 5 (10%) 30 (60%) 40 (80%)
Skin, Site of Application, Inflammation 3 (6%) 2 (4%) 11 (22%)
Skin, Site of Application, Parakeratosis 3 (6%) 4 (8%) 16 (32%)
Skin, Site of Application, Ulcer 1 (2%) 3 (6%)
Subcutaneous Tissue, Control, Hemorrhage 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (50) (50) (50)
Osteomalacia 1 (2%)
Joint, Inflammation, Chronic 1 (2%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (50) (50)
Cyst Epithelial Inclusion 1 (2%)
Neuron, Necrosis 2 (4%) 3 (6%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (50) (50)
Inflammation 2 (4%) 1 (2%)
Alveolar Epithelium, Hyperplasia 1 (2%) 1 (2%) 2 (4%)
Nose (50) (50) (49)
Inflammation 1 (2%) 2 (4%)
Nasolacrimal Duct, Inflammation 1 (2%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 5
NTP Experiment-Test: 55312-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC COCONUT OIL ACID DIETHANOLAMINE CONDENSATE Date: 09/18/97
Route: SKIN APPLICATION Time: 08:14:59
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 MG/KG 100 200
MG/KG MG/KG
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (1) (2) (1)
Degeneration 1 (50%)
Cornea, Inflammation 1 (100%) 1 (100%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (50) (50)
Accumulation, Hyaline Droplet 2 (4%) 1 (2%)
Cyst 1 (2%)
Hydronephrosis 1 (2%) 1 (2%) 1 (2%)
Mineralization 2 (4%)
Nephropathy 27 (54%) 24 (48%) 15 (30%)
Pigmentation, Hemosiderin 1 (2%) 2 (4%)
Pigmentation, Hemoglobin 1 (2%)
Glomerulus, Thrombosis 1 (2%)
Renal Tubule, Degeneration 1 (2%)
Urinary Bladder (50) (50) (50)
Inflammation 1 (2%)
Transitional Epithelium, Hyperplasia 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 6
NTP Experiment-Test: 55312-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC COCONUT OIL ACID DIETHANOLAMINE CONDENSATE Date: 09/18/97
Route: SKIN APPLICATION Time: 08:14:59
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 MG/KG 100 200
MG/KG MG/KG
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 50 50 50
Early Deaths
Moribund Sacrifice 5 7 7
Natural Death 4 6 7
Survivors
Terminal Sacrifice 41 37 36
Animals Examined Microscopically 50 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Intestine Small, Duodenum (49) (50) (50)
Ulcer 1 (2%)
Intestine Small, Jejunum (50) (50) (50)
Inflammation 1 (2%)
Lymphatic, Hyperplasia 1 (2%)
Liver (50) (50) (50)
Angiectasis 1 (2%)
Basophilic Focus 3 (6%)
Clear Cell Focus 8 (16%) 8 (16%) 4 (8%)
Degeneration, Cystic 1 (2%)
Eosinophilic Focus 20 (40%) 29 (58%) 31 (62%)
Hematopoietic Cell Proliferation 1 (2%) 1 (2%)
Mixed Cell Focus 6 (12%) 7 (14%) 6 (12%)
Necrosis 1 (2%) 3 (6%) 2 (4%)
Bile Duct, Hyperplasia 1 (2%)
Mesentery (3) (3) (4)
Artery, Inflammation 1 (25%)
Fat, Necrosis 1 (33%) 1 (33%) 2 (50%)
Pancreas (50) (50) (50)
Atrophy 2 (4%) 2 (4%) 5 (10%)
Hypertrophy, Focal 1 (2%)
Inflammation, Granulomatous 1 (2%)
Duct, Cyst 1 (2%) 1 (2%)
Duct, Hyperplasia 1 (2%)
Salivary Glands (50) (50) (50)
Inflammation 1 (2%)
Inflammation, Granulomatous 1 (2%)
Stomach, Forestomach (50) (50) (50)
Hyperplasia, Focal 1 (2%) 1 (2%)
Ulcer 1 (2%)
Stomach, Glandular (50) (50) (50)
Dysplasia 1 (2%)
Erosion 1 (2%)
Hyperplasia 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 7
NTP Experiment-Test: 55312-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC COCONUT OIL ACID DIETHANOLAMINE CONDENSATE Date: 09/18/97
Route: SKIN APPLICATION Time: 08:14:59
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 MG/KG 100 200
MG/KG MG/KG
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Inflammation, Granulomatous 1 (2%)
Tooth (1)
Inflammation 1 (100%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Blood Vessel (50) (50) (50)
Aorta, Inflammation 1 (2%)
Heart (50) (50) (50)
Degeneration 3 (6%)
Artery, Inflammation 1 (2%)
Atrium, Thrombosis 1 (2%)
Coronary Artery, Thrombosis 1 (2%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (50) (50) (50)
Angiectasis 1 (2%)
Hyperplasia 3 (6%) 6 (12%) 3 (6%)
Hypertrophy 28 (56%) 30 (60%) 26 (52%)
Necrosis 1 (2%)
Capsule, Hyperplasia 8 (16%) 15 (30%) 11 (22%)
Adrenal Medulla (50) (50) (50)
Hyperplasia 2 (4%) 2 (4%)
Islets, Pancreatic (50) (50) (50)
Hyperplasia 21 (42%) 23 (46%) 21 (42%)
Pituitary Gland (45) (47) (49)
Cyst 2 (4%) 3 (6%)
Pars Distalis, Hyperplasia 4 (9%) 2 (4%) 4 (8%)
Pars Intermedia, Hyperplasia 1 (2%) 1 (2%)
Thyroid Gland (50) (50) (50)
Follicular Cell, Hyperplasia 11 (22%) 20 (40%) 23 (46%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Epididymis (50) (50) (50)
Granuloma Sperm 2 (4%) 1 (2%) 2 (4%)
Penis (1)
Congestion 1 (100%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 8
NTP Experiment-Test: 55312-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC COCONUT OIL ACID DIETHANOLAMINE CONDENSATE Date: 09/18/97
Route: SKIN APPLICATION Time: 08:14:59
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 MG/KG 100 200
MG/KG MG/KG
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM - CONT
Preputial Gland (49) (50) (50)
Cyst 21 (43%) 21 (42%) 14 (28%)
Inflammation 1 (2%) 1 (2%)
Prostate (50) (50) (50)
Inflammation 1 (2%) 1 (2%)
Seminal Vesicle (50) (49) (50)
Inflammation, Granulomatous 1 (2%)
Testes (50) (50) (50)
Atrophy 2 (4%) 2 (4%) 1 (2%)
Mineralization 1 (2%)
Interstitial Cell, Hyperplasia 1 (2%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (50) (50) (50)
Hyperplasia 10 (20%) 10 (20%) 19 (38%)
Lymph Node, Mandibular (47) (45) (44)
Hematopoietic Cell Proliferation 1 (2%)
Lymph Node, Mesenteric (46) (48) (47)
Angiectasis 1 (2%) 1 (2%) 1 (2%)
Atrophy 2 (4%)
Hematopoietic Cell Proliferation 2 (4%) 2 (4%) 3 (6%)
Hemorrhage 1 (2%)
Hyperplasia, Lymphoid 1 (2%) 2 (4%)
Inflammation, Granulomatous 1 (2%)
Spleen (50) (50) (50)
Angiectasis 1 (2%)
Fibrosis 1 (2%)
Hematopoietic Cell Proliferation 25 (50%) 23 (46%) 30 (60%)
Thymus (43) (44) (41)
Atrophy 13 (30%) 13 (30%) 14 (34%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Skin (50) (50) (50)
Control, Edema 1 (2%)
Control, Infiltration Cellular, Mast Cell 1 (2%)
Epidermis, Skin, Site of Application,
Hyperplasia 5 (10%) 47 (94%) 50 (100%)
Lymphatic, Angiectasis 1 (2%)
Sebaceous Gland, Skin, Site of Application,
Hyperplasia 44 (88%) 49 (98%)
Skin, Site of Application, Hyperkeratosis 24 (48%) 23 (46%)
Skin, Site of Application, Inflammation 2 (4%) 2 (4%) 2 (4%)
Skin, Site of Application, Parakeratosis 1 (2%) 4 (8%) 5 (10%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 9
NTP Experiment-Test: 55312-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC COCONUT OIL ACID DIETHANOLAMINE CONDENSATE Date: 09/18/97
Route: SKIN APPLICATION Time: 08:14:59
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 MG/KG 100 200
MG/KG MG/KG
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM - CONT
Skin, Site of Application, Ulcer 1 (2%) 7 (14%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (50) (50) (50)
Hyperostosis 1 (2%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (50) (50)
Neuron, Necrosis 1 (2%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (50) (50)
Inflammation 1 (2%) 1 (2%)
Inflammation, Granulomatous 1 (2%)
Pigmentation, Hemosiderin 1 (2%)
Alveolar Epithelium, Hyperplasia 4 (8%) 4 (8%) 1 (2%)
Nose (50) (50) (50)
Inflammation 1 (2%) 1 (2%)
Nasolacrimal Duct, Inflammation 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (1) (2) (1)
Cornea, Inflammation 2 (100%) 1 (100%)
Harderian Gland (3) (3) (6)
Hyperplasia 1 (33%) 1 (17%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (50) (50)
Accumulation, Hyaline Droplet 1 (2%) 1 (2%)
Cyst 12 (24%) 16 (32%) 11 (22%)
Inflammation, Granulomatous 1 (2%)
Inflammation, Suppurative 1 (2%)
Nephropathy 47 (94%) 49 (98%) 50 (100%)
Pigmentation, Hemosiderin 3 (6%)
Artery, Inflammation 2 (4%) 1 (2%)
Renal Tubule, Hyperplasia 1 (2%) 2 (4%)
Ureter (1) (1)
a Number of animals examined microscopically at site and number of animals with lesion
Page 10
NTP Experiment-Test: 55312-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC COCONUT OIL ACID DIETHANOLAMINE CONDENSATE Date: 09/18/97
Route: SKIN APPLICATION Time: 08:14:59
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 MG/KG 100 200
MG/KG MG/KG
____________________________________________________________________________________________________________________________________
URINARY SYSTEM - CONT
Inflammation, Granulomatous 1 (100%)
Urinary Bladder (50) (50) (50)
Inflammation 1 (2%)
Inflammation, Granulomatous 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 11
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