TDMS Study 55323-04 Pathology Tables
NTP Experiment-Test: 55323-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC LAURIC ACID DIETHANOLAMINE CONDENSATE Date: 07/30/97
Route: SKIN APPLICATION Time: 07:26:42
2 YEAR CHRONIC
Facility: Battelle Columbus Laboratory
Chemical CAS #: 120-40-1
Lock Date: 07/13/95
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: 55323-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC LAURIC ACID DIETHANOLAMINE CONDENSATE Date: 07/30/97
Route: SKIN APPLICATION Time: 07:26:42
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 MG/KG 100 200
MG/KG MG/KG
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 50 50 50
Early Deaths
Natural Death 4 2 5
Moribund Sacrifice 9 7 15
Accidently Killed 1
Survivors
Terminal Sacrifice 37 40 29
Missing 1
Animals Examined Microscopically 50 49 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Esophagus (50) (49) (50)
Inflammation, Chronic Active 1 (2%)
Intestine Small, Duodenum (50) (49) (50)
Hyperplasia 1 (2%)
Ulcer 2 (4%)
Liver (50) (49) (50)
Angiectasis 1 (2%)
Clear Cell Focus 2 (4%) 2 (4%) 1 (2%)
Degeneration, Fatty, Focal 2 (4%)
Eosinophilic Focus 15 (30%) 20 (41%) 23 (46%)
Hematopoietic Cell Proliferation 1 (2%)
Hepatodiaphragmatic Nodule 1 (2%)
Infarct 1 (2%)
Mixed Cell Focus 2 (4%)
Necrosis, Focal 2 (4%)
Bile Duct, Cyst 1 (2%)
Mesentery (7) (10) (4)
Fat, Necrosis 7 (100%) 10 (100%) 3 (75%)
Pancreas (50) (49) (50)
Infiltration Cellular, Lymphocyte 1 (2%)
Inflammation, Chronic 1 (2%)
Acinus, Atrophy 1 (2%) 2 (4%)
Stomach, Forestomach (50) (49) (50)
Ulcer 3 (6%)
Epithelium, Hyperkeratosis 2 (4%)
Stomach, Glandular (50) (49) (50)
Inflammation, Chronic 1 (2%)
Ulcer 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 2
NTP Experiment-Test: 55323-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC LAURIC ACID DIETHANOLAMINE CONDENSATE Date: 07/30/97
Route: SKIN APPLICATION Time: 07:26:42
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 MG/KG 100 200
MG/KG MG/KG
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (50) (49) (50)
Artery, Inflammation, Chronic 1 (2%)
Atrium, Thrombosis 1 (2%) 1 (2%)
Myocardium, Degeneration 5 (10%) 10 (20%) 5 (10%)
Myocardium, Mineralization, Focal 1 (2%)
Ventricle, Inflammation, Chronic, Focal 1 (2%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (50) (49) (50)
Accessory Adrenal Cortical Nodule 1 (2%)
Hyperplasia, Focal 1 (2%) 4 (8%)
Necrosis, Acute 1 (2%)
Adrenal Medulla (50) (49) (50)
Hyperplasia, Focal 2 (4%) 2 (4%) 2 (4%)
Necrosis 1 (2%)
Islets, Pancreatic (50) (49) (50)
Hyperplasia 2 (4%) 9 (18%) 6 (12%)
Pituitary Gland (47) (49) (50)
Pars Distalis, Angiectasis, Focal 1 (2%)
Pars Distalis, Hyperplasia, Focal 11 (23%) 6 (12%) 11 (22%)
Pars Distalis, Necrosis, Focal 1 (2%)
Thyroid Gland (50) (49) (50)
Inflammation, Chronic 1 (2%)
C-Cell, Hyperplasia 2 (4%)
Follicle, Hyperplasia, Diffuse 1 (2%)
Follicle, Hyperplasia, Focal 38 (76%) 34 (69%) 36 (72%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Clitoral Gland (49) (47) (49)
Cyst 1 (2%) 1 (2%) 1 (2%)
Ovary (50) (49) (50)
Angiectasis 1 (2%) 1 (2%)
Cyst 6 (12%) 9 (18%) 8 (16%)
Thrombosis 1 (2%) 1 (2%)
Uterus (50) (49) (50)
Angiectasis 1 (2%) 1 (2%) 2 (4%)
Inflammation, Granulomatous 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 3
NTP Experiment-Test: 55323-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC LAURIC ACID DIETHANOLAMINE CONDENSATE Date: 07/30/97
Route: SKIN APPLICATION Time: 07:26:42
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 MG/KG 100 200
MG/KG MG/KG
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM - CONT
Endometrium, Hyperplasia, Cystic 38 (76%) 46 (94%) 39 (78%)
Myometrium, Hyperplasia 1 (2%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Lymph Node (5) (4) (7)
Mediastinal, Hyperplasia, Lymphoid 1 (20%) 1 (25%)
Renal, Hyperplasia, Lymphoid 1 (20%) 1 (25%)
Lymph Node, Mandibular (46) (48) (48)
Hyperplasia, Lymphoid 1 (2%)
Lymph Node, Mesenteric (49) (48) (47)
Angiectasis 1 (2%)
Hyperplasia, Lymphoid 1 (2%)
Spleen (50) (49) (50)
Hematopoietic Cell Proliferation 7 (14%) 6 (12%) 9 (18%)
Hyperplasia, Lymphoid 6 (12%) 3 (6%) 1 (2%)
Thymus (50) (47) (50)
Ectopic Parathyroid Gland 1 (2%)
Hemorrhage 1 (2%)
Hyperplasia, Lymphoid 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Skin (50) (49) (50)
Epidermis, Skin, Site of Application,
Hyperplasia 42 (86%) 50 (100%)
Sebaceous Gland, Skin, Site of Application,
Hyperplasia 43 (88%) 45 (90%)
Skin, Site of Application, Hyperkeratosis 4 (8%) 41 (84%) 48 (96%)
Skin, Site of Application, Inflammation,
Chronic Active 24 (49%) 40 (80%)
Skin, Site of Application, Parakeratosis 3 (6%) 9 (18%)
Skin, Site of Application, Ulcer 3 (6%)
Subcutaneous Tissue, Edema 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (50) (49) (50)
Fibrosis 1 (2%) 3 (6%)
Fibrous Osteodystrophy 1 (2%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 4
NTP Experiment-Test: 55323-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC LAURIC ACID DIETHANOLAMINE CONDENSATE Date: 07/30/97
Route: SKIN APPLICATION Time: 07:26:42
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 MG/KG 100 200
MG/KG MG/KG
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (49) (50)
Meninges, Infiltration Cellular, Mixed Cell 1 (2%)
Spinal Cord (1)
Axon, Nerve, Degeneration 1 (100%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (49) (50)
Hemorrhage, Focal 1 (2%) 1 (2%)
Inflammation, Granulomatous 1 (2%)
Thrombosis 1 (2%)
Alveolar Epithelium, Hyperplasia, Focal 2 (4%) 1 (2%) 1 (2%)
Mediastinum, Inflammation, Chronic Active 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
None
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (49) (50)
Infarct 1 (2%)
Nephropathy 19 (38%) 30 (61%) 16 (32%)
Urinary Bladder (50) (49) (50)
Artery, Inflammation, Chronic 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 5
NTP Experiment-Test: 55323-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC LAURIC ACID DIETHANOLAMINE CONDENSATE Date: 07/30/97
Route: SKIN APPLICATION Time: 07:26:42
____________________________________________________________________________________________________________________________________
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 7 6 7
Natural Death 3 7 2
Survivors
Terminal Sacrifice 40 37 41
Animals Examined Microscopically 50 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Intestine Small, Jejunum (50) (50) (50)
Peyer's Patch, Hyperplasia, Lymphoid 1 (2%)
Liver (50) (50) (50)
Basophilic Focus 1 (2%) 2 (4%) 1 (2%)
Clear Cell Focus 14 (28%) 7 (14%) 6 (12%)
Eosinophilic Focus 15 (30%) 9 (18%) 15 (30%)
Fibrosis, Focal 1 (2%)
Hepatodiaphragmatic Nodule 2 (4%)
Mixed Cell Focus 2 (4%) 5 (10%) 2 (4%)
Necrosis, Focal 1 (2%) 3 (6%)
Bile Duct, Cyst 2 (4%)
Bile Duct, Hyperplasia 1 (2%)
Hepatocyte, Centrilobular, Hypertrophy 1 (2%) 1 (2%)
Mesentery (1) (2)
Artery, Inflammation, Chronic 1 (100%)
Fat, Necrosis 2 (100%)
Pancreas (50) (50) (50)
Inflammation, Chronic 1 (2%)
Stomach, Forestomach (50) (50) (50)
Hemorrhage 1 (2%)
Hyperkeratosis 1 (2%) 1 (2%)
Hyperplasia, Focal 1 (2%)
Ulcer 1 (2%) 1 (2%)
Stomach, Glandular (50) (50) (50)
Ulcer 1 (2%)
Epithelium, Hyperplasia, Focal 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (50) (50) (50)
Artery, Inflammation, Chronic 1 (2%) 1 (2%)
Myocardium, Degeneration 5 (10%) 3 (6%) 8 (16%)
Myocardium, Mineralization 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 6
NTP Experiment-Test: 55323-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC LAURIC ACID DIETHANOLAMINE CONDENSATE Date: 07/30/97
Route: SKIN APPLICATION Time: 07:26:42
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 MG/KG 100 200
MG/KG MG/KG
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (50) (50) (50)
Accessory Adrenal Cortical Nodule 1 (2%)
Angiectasis 1 (2%)
Hyperplasia, Focal 30 (60%) 17 (34%) 24 (48%)
Hypertrophy 1 (2%) 1 (2%)
Inflammation, Chronic 1 (2%)
Adrenal Medulla (50) (50) (49)
Hyperplasia, Focal 2 (4%)
Islets, Pancreatic (50) (50) (50)
Hyperplasia 27 (54%) 28 (56%) 12 (24%)
Parathyroid Gland (40) (42) (43)
Cyst 1 (3%)
Pituitary Gland (48) (49) (50)
Angiectasis 1 (2%)
Pars Distalis, Hyperplasia, Focal 1 (2%) 1 (2%)
Thyroid Gland (50) (50) (50)
Follicle, Hyperplasia, Focal 18 (36%) 24 (48%) 36 (72%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Epididymis (50) (50) (50)
Granuloma Sperm 1 (2%)
Preputial Gland (50) (50) (50)
Cyst 23 (46%) 19 (38%) 16 (32%)
Hyperplasia 1 (2%)
Inflammation, Granulomatous 1 (2%)
Inflammation, Suppurative 1 (2%)
Bilateral, Cyst 2 (4%)
Seminal Vesicle (50) (50) (50)
Fibrosis 1 (2%) 1 (2%)
Inflammation, Chronic 1 (2%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Lymph Node, Mesenteric (49) (49) (50)
Hyperplasia, Lymphoid 2 (4%) 2 (4%)
Spleen (50) (50) (50)
Hematopoietic Cell Proliferation 6 (12%) 7 (14%) 2 (4%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 7
NTP Experiment-Test: 55323-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC LAURIC ACID DIETHANOLAMINE CONDENSATE Date: 07/30/97
Route: SKIN APPLICATION Time: 07:26:42
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 MG/KG 100 200
MG/KG MG/KG
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - CONT
Hyperplasia, Lymphoid 3 (6%) 2 (4%)
Thymus (45) (45) (49)
Hyperplasia 1 (2%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Skin (50) (50) (50)
Hyperkeratosis 1 (2%)
Epidermis, Skin, Site of Application,
Hyperplasia 4 (8%) 45 (90%) 50 (100%)
Pinna, Fibrosis, Focal 1 (2%)
Sebaceous Gland, Skin, Site of Application,
Hyperplasia 1 (2%) 45 (90%) 48 (96%)
Skin, Site of Application, Hyperkeratosis 3 (6%) 45 (90%) 49 (98%)
Skin, Site of Application, Inflammation,
Chronic Active 1 (2%) 13 (26%) 28 (56%)
Skin, Site of Application, Parakeratosis 1 (2%) 5 (10%)
Skin, Site of Application, Ulcer 2 (4%)
Subcutaneous Tissue, Edema 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
None
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
None
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (50) (50)
Inflammation, Granulomatous 1 (2%)
Thrombosis 1 (2%)
Alveolar Epithelium, Hyperplasia, Focal 1 (2%) 3 (6%) 2 (4%)
Mediastinum, Infiltration Cellular, Mast Cell 1 (2%)
Nose (50) (50) (50)
Inflammation, Suppurative 2 (4%)
Polyp, Inflammatory 2 (4%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 8
NTP Experiment-Test: 55323-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC LAURIC ACID DIETHANOLAMINE CONDENSATE Date: 07/30/97
Route: SKIN APPLICATION Time: 07:26:42
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 MG/KG 100 200
MG/KG MG/KG
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (3)
Degeneration 1 (33%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (50) (50)
Infarct 1 (2%)
Nephropathy 28 (56%) 31 (62%) 33 (66%)
Artery, Inflammation, Chronic 1 (2%)
Renal Tubule, Cyst 2 (4%) 2 (4%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 9
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