TDMS Study 55312-03 Pathology Tables
NTP Experiment-Test: 55312-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC COCONUT OIL ACID DIETHANOLAMINE CONDENSATE Date: 01/28/99
Route: SKIN APPLICATION Time: 08:08:18
2 YEAR CHRONIC RATS
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: 55312-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC COCONUT OIL ACID DIETHANOLAMINE CONDENSATE Date: 01/28/99
Route: SKIN APPLICATION Time: 08:08:18
____________________________________________________________________________________________________________________________________
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 15 11 18
Moribund Sacrifice 7 15 10
Survivors
Terminal Sacrifice 28 24 21
Moribund Sacrifice 1
Animals Examined Microscopically 50 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Intestine Small, Duodenum (50) (50) (50)
Liver (50) (50) (50)
Hepatocellular Adenoma 1 (2%)
Histiocytic Sarcoma 1 (2%)
Mesentery (4) (5) (2)
Oral Mucosa (1) (1) (3)
Gingival, Squamous Cell Carcinoma 1 (33%)
Pancreas (50) (50) (50)
Salivary Glands (50) (50) (49)
Stomach, Forestomach (50) (50) (50)
Squamous Cell Papilloma 1 (2%)
Squamous Cell Papilloma, Multiple 1 (2%)
Stomach, Glandular (50) (50) (50)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (50) (50) (50)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (50) (50) (50)
Adenoma 2 (4%)
Adrenal Medulla (50) (50) (50)
Histiocytic Sarcoma 1 (2%)
Pheochromocytoma Benign 4 (8%)
Islets, Pancreatic (50) (50) (50)
Adenoma 1 (2%) 2 (4%)
Parathyroid Gland (42) (46) (45)
Adenoma 1 (2%)
Pituitary Gland (50) (49) (50)
NTP Experiment-Test: 55312-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC COCONUT OIL ACID DIETHANOLAMINE CONDENSATE Date: 01/28/99
Route: SKIN APPLICATION Time: 08:08:18
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 MG/KG 50 MG/KG 100
MG/KG
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM - cont
Pars Distalis, Adenoma 27 (54%) 26 (53%) 24 (48%)
Pars Intermedia, Adenoma 1 (2%)
Thyroid Gland (50) (50) (50)
C-Cell, Adenoma 4 (8%) 3 (6%) 6 (12%)
C-Cell, Carcinoma 1 (2%) 2 (4%) 2 (4%)
Follicular Cell, Adenoma 2 (4%)
Follicular Cell, Carcinoma 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Clitoral Gland (49) (50) (50)
Adenoma 7 (14%) 5 (10%) 4 (8%)
Carcinoma 1 (2%) 6 (12%) 2 (4%)
Bilateral, Adenoma 1 (2%)
Bilateral, Carcinoma 1 (2%) 2 (4%) 2 (4%)
Ovary (50) (50) (50)
Granulosa-Theca Tumor Malignant 1 (2%)
Granulosa-Theca Tumor Benign 1 (2%)
Histiocytic Sarcoma 1 (2%)
Uterus (50) (50) (50)
Deciduoma Benign 1 (2%)
Leiomyosarcoma 1 (2%)
Polyp Stromal 6 (12%) 6 (12%) 5 (10%)
Sarcoma Stromal 1 (2%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (50) (50) (50)
Lymph Node (41) (36) (36)
Mediastinal, Histiocytic Sarcoma 1 (2%)
Lymph Node, Mandibular (50) (48) (47)
Lymph Node, Mesenteric (50) (50) (50)
Histiocytic Sarcoma 1 (2%)
Spleen (50) (50) (50)
Thymus (47) (50) (49)
Histiocytic Sarcoma 1 (2%)
Thymoma Benign 1 (2%)
____________________________________________________________________________________________________________________________________
NTP Experiment-Test: 55312-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC COCONUT OIL ACID DIETHANOLAMINE CONDENSATE Date: 01/28/99
Route: SKIN APPLICATION Time: 08:08:18
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 MG/KG 50 MG/KG 100
MG/KG
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (49) (50) (50)
Adenoma 1 (2%)
Carcinoma 2 (4%) 1 (2%) 2 (4%)
Carcinoma, Multiple 1 (2%)
Fibroadenoma 17 (35%) 14 (28%) 3 (6%)
Fibroadenoma, Multiple 1 (2%) 2 (4%)
Skin (50) (50) (50)
Squamous Cell Papilloma, Multiple 1 (2%)
Sebaceous Gland, Skin, Site of Application,
Adenoma 1 (2%)
Subcutaneous Tissue, Histiocytic Sarcoma 1 (2%)
Subcutaneous Tissue, Pinna, Melanoma
Malignant 1 (2%)
Subcutaneous Tissue, Skin, Site of
Application, Fibrosarcoma 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (50) (50) (50)
Femur, Osteosarcoma 1 (2%)
Skeletal Muscle (3) (1)
Histiocytic Sarcoma 1 (33%)
Osteosarcoma, Metastatic, Bone 1 (33%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (50) (50)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (50) (50)
Granulosa-Theca Tumor Malignant, Metastatic,
Ovary 1 (2%)
Histiocytic Sarcoma 1 (2%)
Osteosarcoma, Metastatic, Bone 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
None
____________________________________________________________________________________________________________________________________
NTP Experiment-Test: 55312-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC COCONUT OIL ACID DIETHANOLAMINE CONDENSATE Date: 01/28/99
Route: SKIN APPLICATION Time: 08:08:18
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 MG/KG 50 MG/KG 100
MG/KG
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (50) (50)
Renal Tubule, Carcinoma 2 (4%)
Urinary Bladder (50) (50) (50)
Papilloma 1 (2%)
Transitional Epithelium, Papilloma 1 (2%)
____________________________________________________________________________________________________________________________________
SYSTEMIC LESIONS
Multiple Organs *(50) *(50) *(50)
Histiocytic Sarcoma 1 (2%)
Leukemia Mononuclear 10 (20%) 9 (18%) 4 (8%)
Lymphoma Malignant 2 (4%)
____________________________________________________________________________________________________________________________________
* Number of animals with any tissue examined microscopically
Page 5
NTP Experiment-Test: 55312-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC COCONUT OIL ACID DIETHANOLAMINE CONDENSATE Date: 01/28/99
Route: SKIN APPLICATION Time: 08:08:18
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 MG/KG 50 MG/KG 100
MG/KG
____________________________________________________________________________________________________________________________________
TUMOR SUMMARY
Total Animals with Primary Neoplasms (b) 48 43 37
Total Primary Neoplasms 89 93 65
Total Animals with Benign Neoplasms 43 39 34
Total Benign Neoplasms 69 66 50
Total Animals with Malignant Neoplasms 19 20 15
Total Malignant Neoplasms 20 27 15
Total Animals with Metastatic Neoplasms 2
Total Metastatic Neoplasm 3
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
NTP Experiment-Test: 55312-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC COCONUT OIL ACID DIETHANOLAMINE CONDENSATE Date: 01/28/99
Route: SKIN APPLICATION Time: 08:08:18
____________________________________________________________________________________________________________________________________
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 28 27 25
Natural Death 13 11 14
Accidently Killed 1
Survivors
Terminal Sacrifice 8 12 11
Animals Examined Microscopically 50 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Esophagus (50) (50) (50)
Thymoma Malignant, Metastatic, Thymus 1 (2%)
Intestine Large, Colon (50) (50) (50)
Polyp Adenomatous 1 (2%) 1 (2%)
Intestine Small, Ileum (50) (50) (50)
Liver (50) (50) (50)
Mesentery (8) (7) (6)
Fat, Fibrosarcoma 1 (14%)
Oral Mucosa (1) (2) (2)
Gingival, Squamous Cell Carcinoma 1 (50%)
Pharyngeal, Squamous Cell Papilloma 1 (100%)
Pancreas (50) (50) (50)
Acinus, Adenoma 1 (2%)
Salivary Glands (50) (50) (50)
Stomach, Forestomach (50) (50) (50)
Squamous Cell Papilloma 3 (6%) 1 (2%)
Squamous Cell Papilloma, Multiple 1 (2%)
Stomach, Glandular (50) (50) (50)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (50) (50) (50)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (50) (50) (50)
Adenoma 1 (2%)
Adrenal Medulla (50) (50) (50)
Ganglioneuroma 1 (2%)
Pheochromocytoma Malignant 1 (2%)
NTP Experiment-Test: 55312-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC COCONUT OIL ACID DIETHANOLAMINE CONDENSATE Date: 01/28/99
Route: SKIN APPLICATION Time: 08:08:18
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 MG/KG 50 MG/KG 100
MG/KG
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM - cont
Pheochromocytoma Benign 6 (12%) 4 (8%) 5 (10%)
Bilateral, Pheochromocytoma Benign 1 (2%) 1 (2%)
Islets, Pancreatic (50) (50) (50)
Adenoma 3 (6%) 4 (8%) 3 (6%)
Pituitary Gland (50) (50) (49)
Sarcoma, Metastatic, Brain 1 (2%)
Pars Distalis, Adenoma 37 (74%) 39 (78%) 36 (73%)
Thyroid Gland (50) (50) (50)
C-Cell, Adenoma 3 (6%) 4 (8%) 4 (8%)
C-Cell, Carcinoma 1 (2%)
Follicular Cell, Adenoma 3 (6%) 1 (2%)
Follicular Cell, Carcinoma 2 (4%) 1 (2%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
Peritoneum (1)
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Epididymis (50) (50) (50)
Preputial Gland (50) (50) (50)
Adenoma 2 (4%) 1 (2%)
Carcinoma 1 (2%) 2 (4%)
Bilateral, Adenoma 1 (2%)
Prostate (50) (50) (50)
Carcinoma 2 (4%)
Seminal Vesicle (50) (50) (50)
Testes (50) (50) (50)
Bilateral, Interstitial Cell, Adenoma 11 (22%) 9 (18%) 12 (24%)
Interstitial Cell, Adenoma 12 (24%) 11 (22%) 7 (14%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (50) (50) (50)
Lymph Node (35) (30) (37)
Mediastinal, Fibrosarcoma, Metastatic, Skin 1 (3%)
Lymph Node, Mandibular (50) (50) (50)
Lymph Node, Mesenteric (49) (50) (50)
Spleen (50) (50) (50)
Hemangiosarcoma 1 (2%)
Thymus (47) (45) (48)
Thymoma Malignant 1 (2%)
____________________________________________________________________________________________________________________________________
NTP Experiment-Test: 55312-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC COCONUT OIL ACID DIETHANOLAMINE CONDENSATE Date: 01/28/99
Route: SKIN APPLICATION Time: 08:08:18
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 MG/KG 50 MG/KG 100
MG/KG
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (48) (49) (50)
Adenoma 1 (2%)
Carcinoma 1 (2%) 1 (2%)
Fibroadenoma 2 (4%) 1 (2%) 1 (2%)
Skin (50) (50) (50)
Basal Cell Carcinoma 1 (2%)
Keratoacanthoma 2 (4%) 4 (8%)
Squamous Cell Papilloma 1 (2%) 1 (2%)
Trichoepithelioma 1 (2%)
Pinna, Squamous Cell Papilloma 1 (2%)
Sebaceous Gland, Carcinoma 1 (2%)
Sebaceous Gland, Skin, Site of Application,
Adenoma 1 (2%)
Skin, Site of Application, Basal Cell Adenoma 1 (2%)
Skin, Site of Application, Basal Cell
Carcinoma 1 (2%)
Skin, Site of Application, Keratoacanthoma 1 (2%) 2 (4%)
Subcutaneous Tissue, Fibroma 3 (6%) 3 (6%) 1 (2%)
Subcutaneous Tissue, Fibrosarcoma 2 (4%) 1 (2%)
Subcutaneous Tissue, Skin, Site of
Application, Fibrosarcoma 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (50) (50) (50)
Osteosarcoma 1 (2%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (50) (50)
Cranial Nerve, Schwannoma Malignant 1 (2%)
Meninges, Sarcoma 1 (2%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (50) (50)
Thymoma Malignant, Metastatic, Thymus 1 (2%)
Nose (50) (50) (50)
Squamous Cell Carcinoma 1 (2%)
____________________________________________________________________________________________________________________________________
NTP Experiment-Test: 55312-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC COCONUT OIL ACID DIETHANOLAMINE CONDENSATE Date: 01/28/99
Route: SKIN APPLICATION Time: 08:08:18
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 MG/KG 50 MG/KG 100
MG/KG
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Zymbal's Gland (1) (2)
Carcinoma 1 (100%) 2 (100%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (50) (50)
Lipoma 1 (2%)
Thymoma Malignant, Metastatic, Thymus 1 (2%)
Renal Tubule, Adenoma 1 (2%) 4 (8%)
Renal Tubule, Adenoma, Multiple 1 (2%)
Renal Tubule, Carcinoma 1 (2%)
Urinary Bladder (50) (50) (50)
____________________________________________________________________________________________________________________________________
SYSTEMIC LESIONS
Multiple Organs *(50) *(50) *(50)
Leukemia Granulocytic 1 (2%)
Leukemia Mononuclear 16 (32%) 10 (20%) 12 (24%)
Mesothelioma Malignant 2 (4%) 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
* Number of animals with any tissue examined microscopically
Page 10
NTP Experiment-Test: 55312-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC COCONUT OIL ACID DIETHANOLAMINE CONDENSATE Date: 01/28/99
Route: SKIN APPLICATION Time: 08:08:18
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 MG/KG 50 MG/KG 100
MG/KG
____________________________________________________________________________________________________________________________________
TUMOR SUMMARY
Total Animals with Primary Neoplasms (b) 49 49 48
Total Primary Neoplasms 117 124 98
Total Animals with Benign Neoplasms 48 49 46
Total Benign Neoplasms 90 100 75
Total Animals with Malignant Neoplasms 25 20 21
Total Malignant Neoplasms 27 24 23
Total Animals with Metastatic Neoplasms 1 1 1
Total Metastatic Neoplasm 1 1 3
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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