TDMS Study 55323-03 Pathology Tables
NTP Experiment-Test: 55323-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC LAURIC ACID DIETHANOLAMINE CONDENSATE Date: 07/17/97
Route: SKIN APPLICATION Time: 12:27:12
CORE STUDY
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
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NTP Experiment-Test: 55323-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC LAURIC ACID DIETHANOLAMINE CONDENSATE Date: 07/17/97
Route: SKIN APPLICATION Time: 12:27:12
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 MG/KG 50 MG/KG 100
MG/KG
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially in Study 50 50 50
Early Deaths
Natural Death 11 12 22
Moribund Sacrifice 10 12 5
Accidently Killed 1 1
Survivors
Terminal Sacrifice 28 26 22
Animals Examined Microscopically 50 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Intestine Large, Colon (45) (46) (43)
Intestine Small, Duodenum (49) (49) (49)
Carcinoma, Metastatic, Urinary Bladder 1 (2%)
Intestine Small, Jejunum (42) (43) (38)
Carcinoma, Metastatic, Urinary Bladder 1 (2%)
Liver (50) (50) (50)
Carcinoma, Metastatic, Urinary Bladder 1 (2%)
Mesentery (5) (2) (4)
Carcinoma, Metastatic, Urinary Bladder 1 (20%)
Oral Mucosa (1) (1)
Squamous Cell Papilloma 1 (100%)
Pancreas (50) (50) (49)
Carcinoma, Metastatic, Urinary Bladder 1 (2%)
Salivary Glands (50) (50) (50)
Stomach, Glandular (50) (50) (49)
Carcinoma, Metastatic, Urinary Bladder 1 (2%)
Tongue (1)
Squamous Cell Papilloma 1 (100%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Blood Vessel (50) (50) (50)
Heart (50) (50) (49)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (50) (50) (50)
Adenoma 1 (2%)
Adrenal Medulla (50) (50) (50)
Pheochromocytoma Benign 1 (2%)
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NTP Experiment-Test: 55323-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC LAURIC ACID DIETHANOLAMINE CONDENSATE Date: 07/17/97
Route: SKIN APPLICATION Time: 12:27:12
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 MG/KG 50 MG/KG 100
MG/KG
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM - cont
Islets, Pancreatic (50) (50) (49)
Adenoma 2 (4%)
Carcinoma 1 (2%)
Parathyroid Gland (47) (40) (45)
Pituitary Gland (50) (50) (49)
Pars Distalis, Adenoma 22 (44%) 30 (60%) 30 (61%)
Pars Distalis, Adenoma, Multiple 1 (2%)
Thyroid Gland (50) (50) (50)
C-Cell, Adenoma 1 (2%) 4 (8%) 3 (6%)
C-Cell, Carcinoma 1 (2%)
Follicular Cell, Adenoma 1 (2%) 2 (4%) 1 (2%)
Follicular Cell, Carcinoma 1 (2%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Clitoral Gland (49) (48) (48)
Adenoma 7 (14%) 6 (13%) 6 (13%)
Carcinoma 3 (6%) 3 (6%)
Bilateral, Adenoma 1 (2%)
Ovary (50) (50) (50)
Granulosa Cell Tumor Benign 1 (2%)
Uterus (50) (50) (50)
Carcinoma, Metastatic, Urinary Bladder 1 (2%)
Leiomyosarcoma 1 (2%)
Polyp Stromal 2 (4%) 5 (10%) 5 (10%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (50) (50) (50)
Lymph Node (3) (3) (1)
Lymph Node, Mandibular (49) (50) (49)
Lymph Node, Mesenteric (50) (50) (50)
Carcinoma, Metastatic, Urinary Bladder 1 (2%)
Spleen (50) (50) (50)
Thymus (44) (49) (48)
____________________________________________________________________________________________________________________________________
Page 3
NTP Experiment-Test: 55323-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC LAURIC ACID DIETHANOLAMINE CONDENSATE Date: 07/17/97
Route: SKIN APPLICATION Time: 12:27:12
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 MG/KG 50 MG/KG 100
MG/KG
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (50) (50) (50)
Adenoma 1 (2%) 2 (4%) 2 (4%)
Carcinoma 2 (4%) 3 (6%)
Fibroadenoma 11 (22%) 11 (22%) 9 (18%)
Fibroadenoma, Multiple 1 (2%)
Skin (50) (50) (50)
Subcutaneous Tissue, Fibroma 2 (4%) 1 (2%)
Subcutaneous Tissue, Fibrosarcoma 1 (2%)
Subcutaneous Tissue, Lipoma 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Skeletal Muscle (2)
Carcinoma, Metastatic, Urinary Bladder 1 (50%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (50) (50)
Glioma Malignant 1 (2%)
Hemangioma 1 (2%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (50) (50)
Alveolar/Bronchiolar Adenoma 1 (2%)
Carcinoma, Metastatic, Urinary Bladder 1 (2%)
Squamous Cell Carcinoma 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Zymbal's Gland (1)
Carcinoma 1 (100%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (50) (50)
Carcinoma, Metastatic, Urinary Bladder 1 (2%)
Squamous Cell Carcinoma, Metastatic, Lung 1 (2%)
Renal Tubule, Adenoma 1 (2%)
Urinary Bladder (49) (49) (47)
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NTP Experiment-Test: 55323-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC LAURIC ACID DIETHANOLAMINE CONDENSATE Date: 07/17/97
Route: SKIN APPLICATION Time: 12:27:12
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 MG/KG 50 MG/KG 100
MG/KG
____________________________________________________________________________________________________________________________________
URINARY SYSTEM - cont
Transitional Epithelium, Carcinoma 1 (2%)
____________________________________________________________________________________________________________________________________
SYSTEMIC LESIONS
Multiple Organs *(50) *(50) *(50)
Leukemia Mononuclear 10 (20%) 6 (12%) 5 (10%)
Lymphoma Malignant 1 (2%) 1 (2%)
Mesothelioma Malignant 1 (2%)
____________________________________________________________________________________________________________________________________
* Number of animals with any tissue examined microscopically
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NTP Experiment-Test: 55323-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC LAURIC ACID DIETHANOLAMINE CONDENSATE Date: 07/17/97
Route: SKIN APPLICATION Time: 12:27:12
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 MG/KG 50 MG/KG 100
MG/KG
____________________________________________________________________________________________________________________________________
TUMOR SUMMARY
Total Animals with Primary Neoplasms (b) 40 41 38
Total Primary Neoplasms 69 83 70
Total Animals with Benign Neoplasms 33 39 37
Total Benign Neoplasms 51 69 58
Total Animals with Malignant Neoplasms 18 13 12
Total Malignant Neoplasms 18 14 12
Total Animals with Metastatic Neoplasms 2
Total Metastatic Neoplasm 12
Total Animals with Malignant Neoplasms
Uncertain Primary Site
Total Animals with Neoplasms Uncertain-
Benign or Malignant
Total Uncertain Neoplasms
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
b Primary tumors: all tumors except metastatic tumors
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NTP Experiment-Test: 55323-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC LAURIC ACID DIETHANOLAMINE CONDENSATE Date: 07/17/97
Route: SKIN APPLICATION Time: 12:27:12
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 MG/KG 50 MG/KG 100
MG/KG
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially in Study 50 50 50
Early Deaths
Moribund Sacrifice 31 29 25
Natural Death 7 3 8
Accidently Killed 1
Survivors
Terminal Sacrifice 12 18 16
Animals Examined Microscopically 50 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Intestine Large, Colon (49) (50) (46)
Intestine Large, Cecum (41) (47) (44)
Intestine Small, Duodenum (50) (50) (50)
Intestine Small, Jejunum (45) (50) (46)
Adenocarcinoma 1 (2%)
Intestine Small, Ileum (45) (45) (44)
Liver (50) (50) (50)
Osteosarcoma, Metastatic, Bone 1 (2%)
Pheochromocytoma Malignant, Metastatic,
Adrenal Medulla 1 (2%)
Mesentery (12) (8) (6)
Lipoma 1 (17%)
Oral Mucosa (1) (1)
Squamous Cell Papilloma 1 (100%) 1 (100%)
Pancreas (50) (50) (50)
Salivary Glands (50) (50) (50)
Stomach, Forestomach (50) (50) (50)
Stomach, Glandular (50) (50) (50)
Leiomyosarcoma 1 (2%)
Tongue (1)
Squamous Cell Papilloma 1 (100%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Blood Vessel (50) (50) (50)
Heart (50) (50) (50)
____________________________________________________________________________________________________________________________________
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NTP Experiment-Test: 55323-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC LAURIC ACID DIETHANOLAMINE CONDENSATE Date: 07/17/97
Route: SKIN APPLICATION Time: 12:27:12
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 MG/KG 50 MG/KG 100
MG/KG
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (50) (50) (50)
Adenoma 1 (2%)
Adrenal Medulla (50) (50) (50)
Pheochromocytoma Malignant 2 (4%)
Pheochromocytoma Benign 2 (4%) 2 (4%) 5 (10%)
Bilateral, Pheochromocytoma Benign 2 (4%)
Islets, Pancreatic (50) (50) (50)
Adenoma 2 (4%) 1 (2%) 4 (8%)
Adenoma, Multiple 1 (2%)
Carcinoma 4 (8%) 1 (2%) 2 (4%)
Pituitary Gland (50) (50) (50)
Pars Distalis, Adenoma 48 (96%) 45 (90%) 44 (88%)
Pars Distalis, Adenoma, Multiple 2 (4%)
Thyroid Gland (50) (50) (50)
C-Cell, Adenoma 2 (4%) 3 (6%) 2 (4%)
C-Cell, Carcinoma 1 (2%)
Follicular Cell, Adenoma 1 (2%) 1 (2%)
Follicular Cell, Carcinoma 1 (2%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Epididymis (50) (50) (50)
Preputial Gland (50) (50) (50)
Adenoma 4 (8%) 2 (4%)
Carcinoma 2 (4%) 2 (4%) 1 (2%)
Prostate (50) (50) (49)
Seminal Vesicle (50) (50) (49)
Testes (50) (50) (50)
Interstitial Cell, Adenoma 20 (40%) 22 (44%) 17 (34%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (50) (50) (50)
Pheochromocytoma Malignant, Metastatic,
Adrenal Medulla 1 (2%)
Lymph Node (2) (4)
Lymph Node, Mandibular (50) (50) (50)
Sarcoma 1 (2%)
Lymph Node, Mesenteric (50) (50) (50)
Page 8
NTP Experiment-Test: 55323-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC LAURIC ACID DIETHANOLAMINE CONDENSATE Date: 07/17/97
Route: SKIN APPLICATION Time: 12:27:12
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 MG/KG 50 MG/KG 100
MG/KG
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - cont
Spleen (50) (50) (50)
Fibroma 1 (2%)
Thymus (44) (50) (47)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (50) (50) (49)
Carcinoma 1 (2%)
Fibroadenoma 2 (4%) 2 (4%) 2 (4%)
Skin (50) (50) (50)
Basal Cell Adenoma 1 (2%)
Basal Cell Carcinoma 1 (2%)
Keratoacanthoma 5 (10%) 2 (4%)
Squamous Cell Carcinoma 1 (2%)
Trichoepithelioma 1 (2%) 1 (2%)
Pinna, Squamous Cell Papilloma 1 (2%)
Sebaceous Gland, Skin, Site of Application,
Basal Cell Adenoma 1 (2%)
Skin, Site of Application, Squamous Cell
Papilloma 1 (2%)
Subcutaneous Tissue, Fibroma 3 (6%) 5 (10%) 1 (2%)
Subcutaneous Tissue, Fibrosarcoma 1 (2%) 1 (2%) 2 (4%)
Subcutaneous Tissue, Lipoma 1 (2%)
Subcutaneous Tissue, Myxosarcoma 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (50) (50) (50)
Osteosarcoma 1 (2%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (50) (50)
Meningioma Benign 1 (2%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (50) (50)
Alveolar/Bronchiolar Carcinoma 1 (2%) 1 (2%)
Chordoma, Metastatic, Uncertain Primary Site 1 (2%)
Osteosarcoma, Metastatic, Bone 1 (2%)
Pheochromocytoma Malignant, Metastatic,
Adrenal Medulla 1 (2%)
Page 9
NTP Experiment-Test: 55323-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC LAURIC ACID DIETHANOLAMINE CONDENSATE Date: 07/17/97
Route: SKIN APPLICATION Time: 12:27:12
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 MG/KG 50 MG/KG 100
MG/KG
____________________________________________________________________________________________________________________________________
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Zymbal's Gland (3)
Adenoma 1 (33%)
Carcinoma 2 (67%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (50) (50)
Urinary Bladder (50) (50) (50)
____________________________________________________________________________________________________________________________________
SYSTEMIC LESIONS
Multiple Organs *(50) *(50) *(50)
Leukemia Granulocytic 1 (2%)
Leukemia Mononuclear 6 (12%) 12 (24%) 8 (16%)
Lymphoma Malignant 1 (2%)
Mesothelioma Benign 1 (2%)
Mesothelioma Malignant 6 (12%) 3 (6%) 1 (2%)
____________________________________________________________________________________________________________________________________
* Number of animals with any tissue examined microscopically
Page 10
NTP Experiment-Test: 55323-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC LAURIC ACID DIETHANOLAMINE CONDENSATE Date: 07/17/97
Route: SKIN APPLICATION Time: 12:27:12
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 MG/KG 50 MG/KG 100
MG/KG
____________________________________________________________________________________________________________________________________
TUMOR SUMMARY
Total Animals with Primary Neoplasms (b) 50 49 48
Total Primary Neoplasms 117 109 114
Total Animals with Benign Neoplasms 48 46 48
Total Benign Neoplasms 92 86 92
Total Animals with Malignant Neoplasms 23 21 19
Total Malignant Neoplasms 25 23 22
Total Animals with Metastatic Neoplasms 2 1
Total Metastatic Neoplasm 4 2
Total Animals with Malignant Neoplasms 1
Uncertain Primary Site
Total Animals with Neoplasms Uncertain-
Benign or Malignant
Total Uncertain Neoplasms
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
b Primary tumors: all tumors except metastatic tumors
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