NTP Experiment-Test: 55323-04 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC LAURIC ACID DIETHANOLAMINE CONDENSATE Date: 07/30/97
Route: SKIN APPLICATION Time: 07:31:35
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 NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC LAURIC ACID DIETHANOLAMINE CONDENSATE Date: 07/30/97
Route: SKIN APPLICATION Time: 07:31:35
____________________________________________________________________________________________________________________________________
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
Intestine Small, Duodenum (50) (49) (50)
Polyp Adenomatous 1 (2%)
Intestine Small, Jejunum (50) (49) (50)
Liver (50) (49) (50)
Hemangiosarcoma 2 (4%) 1 (2%)
Hepatoblastoma 1 (2%)
Hepatocellular Carcinoma 7 (14%) 10 (20%) 14 (28%)
Hepatocellular Carcinoma, Multiple 3 (6%) 3 (6%) 2 (4%)
Hepatocellular Adenoma 11 (22%) 18 (37%) 14 (28%)
Hepatocellular Adenoma, Multiple 12 (24%) 15 (31%) 15 (30%)
Histiocytic Sarcoma 2 (4%)
Pheochromocytoma Malignant, Metastatic,
Adrenal Medulla 1 (2%)
Mesentery (7) (10) (4)
Pheochromocytoma Malignant, Metastatic,
Adrenal Medulla 1 (25%)
Pancreas (50) (49) (50)
Hepatocellular Carcinoma, Metastatic, Liver 1 (2%)
Salivary Glands (50) (49) (50)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (50) (49) (50)
Pheochromocytoma Malignant, Metastatic,
Adrenal Medulla 1 (2%)
____________________________________________________________________________________________________________________________________
Page 2
NTP Experiment-Test: 55323-04 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC LAURIC ACID DIETHANOLAMINE CONDENSATE Date: 07/30/97
Route: SKIN APPLICATION Time: 07:31:35
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 MG/KG 100 200
MG/KG MG/KG
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (50) (49) (50)
Adenoma 1 (2%)
Adrenal Medulla (50) (49) (50)
Pheochromocytoma Malignant 1 (2%)
Pheochromocytoma Benign 1 (2%) 2 (4%)
Islets, Pancreatic (50) (49) (50)
Adenoma 1 (2%) 1 (2%)
Pituitary Gland (47) (49) (50)
Pars Distalis, Adenoma 9 (19%) 9 (18%) 7 (14%)
Pars Distalis, Adenoma, Multiple 1 (2%)
Pars Intermedia, Adenoma 1 (2%)
Thyroid Gland (50) (49) (50)
Follicular Cell, Adenoma 4 (8%) 3 (6%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Ovary (50) (49) (50)
Cystadenoma 4 (8%) 1 (2%) 2 (4%)
Granulosa Cell Tumor Malignant 1 (2%)
Granulosa Cell Tumor Benign 2 (4%) 1 (2%)
Granulosa-Theca Tumor Malignant 1 (2%) 1 (2%)
Histiocytic Sarcoma 1 (2%)
Bilateral, Granulosa Cell Tumor Benign 1 (2%)
Uterus (50) (49) (50)
Deciduoma Benign 1 (2%)
Granulosa-Theca Tumor Malignant, Metastatic,
Ovary 1 (2%)
Histiocytic Sarcoma 1 (2%)
Polyp Stromal 2 (4%) 1 (2%)
Schwannoma Malignant 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (50) (49) (50)
Hemangiosarcoma 1 (2%)
Lymph Node (5) (4) (7)
Lumbar, Fibrous Histiocytoma 1 (20%)
Lumbar, Histiocytic Sarcoma 1 (14%)
Mediastinal, Fibrous Histiocytoma 1 (20%)
Page 3
NTP Experiment-Test: 55323-04 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC LAURIC ACID DIETHANOLAMINE CONDENSATE Date: 07/30/97
Route: SKIN APPLICATION Time: 07:31:35
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 MG/KG 100 200
MG/KG MG/KG
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - cont
Mediastinal, Pheochromocytoma Malignant,
Metastatic, Adrenal Medulla 1 (14%)
Popliteal, Fibrous Histiocytoma 1 (20%)
Renal, Fibrous Histiocytoma 1 (20%)
Renal, Hemangiosarcoma 1 (25%)
Lymph Node, Mandibular (46) (48) (48)
Hemangiosarcoma 1 (2%)
Histiocytic Sarcoma 1 (2%)
Lymph Node, Mesenteric (49) (48) (47)
Fibrous Histiocytoma 1 (2%)
Histiocytic Sarcoma 1 (2%)
Spleen (50) (49) (50)
Fibrous Histiocytoma 1 (2%)
Hemangiosarcoma 2 (4%) 1 (2%)
Histiocytic Sarcoma 1 (2%)
Thymus (50) (47) (50)
Histiocytic Sarcoma 1 (2%)
Thymoma Benign 1 (2%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (49) (49) (50)
Carcinoma 1 (2%)
Skin (50) (49) (50)
Subcutaneous Tissue, Fibrosarcoma 2 (4%)
Subcutaneous Tissue, Hemangiosarcoma 1 (2%)
Subcutaneous Tissue, Skin, Site of
Application, Fibrosarcoma 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Skeletal Muscle (1) (1) (1)
Rhabdomyosarcoma 1 (100%) 1 (100%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (49) (50)
____________________________________________________________________________________________________________________________________
Page 4
NTP Experiment-Test: 55323-04 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC LAURIC ACID DIETHANOLAMINE CONDENSATE Date: 07/30/97
Route: SKIN APPLICATION Time: 07:31:35
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 MG/KG 100 200
MG/KG MG/KG
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (49) (50)
Alveolar/Bronchiolar Adenoma 1 (2%) 2 (4%) 1 (2%)
Alveolar/Bronchiolar Carcinoma 7 (14%) 3 (6%) 3 (6%)
Carcinoma, Metastatic, Harderian Gland 1 (2%) 1 (2%)
Granular Cell Tumor Malignant, Metastatic,
Ovary 1 (2%)
Hepatocellular Carcinoma, Metastatic, Liver 3 (6%) 2 (4%) 2 (4%)
Histiocytic Sarcoma 2 (4%)
Pheochromocytoma Malignant, Metastatic,
Adrenal Medulla 1 (2%)
Mediastinum, Hemangiosarcoma 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Harderian Gland (2) (1) (1)
Adenoma 1 (50%)
Carcinoma 1 (50%) 1 (100%) 1 (100%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (49) (50)
Urinary Bladder (50) (49) (50)
____________________________________________________________________________________________________________________________________
SYSTEMIC LESIONS
Multiple Organs *(50) *(49) *(50)
Histiocytic Sarcoma 2 (4%)
Lymphoma Malignant 9 (18%) 5 (10%) 9 (18%)
____________________________________________________________________________________________________________________________________
* Number of animals with any tissue examined microscopically
Page 5
NTP Experiment-Test: 55323-04 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC LAURIC ACID DIETHANOLAMINE CONDENSATE Date: 07/30/97
Route: SKIN APPLICATION Time: 07:31:35
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 MG/KG 100 200
MG/KG MG/KG
____________________________________________________________________________________________________________________________________
TUMOR SUMMARY
Total Animals with Primary Neoplasms (b) 44 43 45
Total Primary Neoplasms 90 82 85
Total Animals with Benign Neoplasms 34 37 35
Total Benign Neoplasms 50 53 44
Total Animals with Malignant Neoplasms 30 22 31
Total Malignant Neoplasms 40 29 41
Total Animals with Metastatic Neoplasms 5 4 3
Total Metastatic Neoplasm 6 4 7
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
Page 6
NTP Experiment-Test: 55323-04 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC LAURIC ACID DIETHANOLAMINE CONDENSATE Date: 07/30/97
Route: SKIN APPLICATION Time: 07:31:35
____________________________________________________________________________________________________________________________________
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
Gallbladder (47) (49) (49)
Intestine Small, Duodenum (50) (50) (49)
Polyp Adenomatous 1 (2%)
Intestine Small, Jejunum (50) (50) (50)
Epithelium, Carcinoma 1 (2%)
Liver (50) (50) (50)
Carcinoid Tumor Malignant, Metastatic,
Stomach, Forestomach 1 (2%)
Carcinoid Tumor Malignant, Metastatic,
Stomach, Glandular 1 (2%)
Carcinoma, Metastatic, Islets, Pancreatic 1 (2%)
Carcinoma, Metastatic, Mammary Gland 1 (2%)
Hemangiosarcoma 7 (14%) 2 (4%) 3 (6%)
Hepatocellular Carcinoma 8 (16%) 8 (16%) 11 (22%)
Hepatocellular Carcinoma, Multiple 3 (6%) 1 (2%)
Hepatocellular Adenoma 13 (26%) 22 (44%) 15 (30%)
Hepatocellular Adenoma, Multiple 6 (12%) 4 (8%) 10 (20%)
Hepatocholangiocarcinoma 1 (2%)
Pancreas (50) (50) (50)
Acinus, Hepatocholangiocarcinoma, Metastatic,
Liver 1 (2%)
Stomach, Forestomach (50) (50) (50)
Stomach, Glandular (50) (50) (50)
Carcinoid Tumor Malignant 1 (2%)
Serosa, Carcinoid Tumor Malignant,
Metastatic, Stomach, Glandular 1 (2%)
____________________________________________________________________________________________________________________________________
Page 7
NTP Experiment-Test: 55323-04 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC LAURIC ACID DIETHANOLAMINE CONDENSATE Date: 07/30/97
Route: SKIN APPLICATION Time: 07:31:35
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 MG/KG 100 200
MG/KG MG/KG
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (50) (50) (50)
Carcinoma, Metastatic, Mammary Gland 1 (2%)
Hepatocellular Carcinoma, Metastatic, Liver 1 (2%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (50) (50) (50)
Adenoma 1 (2%) 4 (8%)
Capsule, Adenoma 1 (2%) 3 (6%) 1 (2%)
Adrenal Medulla (50) (50) (49)
Pheochromocytoma Malignant 1 (2%)
Pheochromocytoma Benign 1 (2%)
Islets, Pancreatic (50) (50) (50)
Adenoma 2 (4%) 1 (2%)
Carcinoma 1 (2%)
Pituitary Gland (48) (49) (50)
Pars Distalis, Adenoma 1 (2%)
Thyroid Gland (50) (50) (50)
Follicular Cell, Adenoma 1 (2%) 4 (8%) 2 (4%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Epididymis (50) (50) (50)
Prostate (50) (50) (50)
Carcinoma, Metastatic, Mammary Gland 1 (2%)
Seminal Vesicle (50) (50) (50)
Testes (50) (50) (50)
Interstitial Cell, Adenoma 1 (2%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (50) (50) (50)
Hemangiosarcoma 1 (2%)
Lymph Node (3) (2) (1)
Mediastinal, Alveolar/Bronchiolar Carcinoma,
Metastatic, Lung 1 (33%)
Mediastinal, Carcinoma, Metastatic, Mammary
Gland 1 (100%)
Page 8
NTP Experiment-Test: 55323-04 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC LAURIC ACID DIETHANOLAMINE CONDENSATE Date: 07/30/97
Route: SKIN APPLICATION Time: 07:31:35
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 MG/KG 100 200
MG/KG MG/KG
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - cont
Lymph Node, Mandibular (46) (45) (46)
Lymph Node, Mesenteric (49) (49) (50)
Carcinoma, Metastatic, Mammary Gland 1 (2%)
Hemangiosarcoma 1 (2%)
Spleen (50) (50) (50)
Hemangiosarcoma 2 (4%) 2 (4%)
Thymus (45) (45) (49)
Hemangioma 1 (2%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (5) (1)
Carcinoma 1 (100%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
None
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (50) (50)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (50) (50)
Alveolar/Bronchiolar Adenoma 5 (10%) 5 (10%) 9 (18%)
Alveolar/Bronchiolar Adenoma, Multiple 1 (2%) 1 (2%) 1 (2%)
Alveolar/Bronchiolar Carcinoma 6 (12%) 8 (16%) 6 (12%)
Alveolar/Bronchiolar Carcinoma, Multiple 2 (4%)
Carcinoma, Metastatic, Islets, Pancreatic 1 (2%)
Carcinoma, Metastatic, Mammary Gland 1 (2%)
Hemangiosarcoma, Metastatic, Liver 1 (2%) 1 (2%)
Hepatocellular Carcinoma, Metastatic, Liver 3 (6%) 2 (4%) 4 (8%)
Hepatocholangiocarcinoma, Metastatic, Liver 1 (2%)
Bronchiole, Adenoma 1 (2%)
Nose (50) (50) (50)
____________________________________________________________________________________________________________________________________
Page 9
NTP Experiment-Test: 55323-04 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC LAURIC ACID DIETHANOLAMINE CONDENSATE Date: 07/30/97
Route: SKIN APPLICATION Time: 07:31:35
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 MG/KG 100 200
MG/KG MG/KG
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Harderian Gland (1) (2) (3)
Adenoma 1 (100%) 2 (100%) 3 (100%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (50) (50)
Carcinoma, Metastatic, Mammary Gland 1 (2%)
Renal Tubule, Adenoma 1 (2%) 1 (2%)
Ureter (1)
Urinary Bladder (50) (50) (50)
____________________________________________________________________________________________________________________________________
SYSTEMIC LESIONS
Multiple Organs *(50) *(50) *(50)
Lymphoma Malignant 4 (8%) 3 (6%) 2 (4%)
____________________________________________________________________________________________________________________________________
* Number of animals with any tissue examined microscopically
Page 10
NTP Experiment-Test: 55323-04 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC LAURIC ACID DIETHANOLAMINE CONDENSATE Date: 07/30/97
Route: SKIN APPLICATION Time: 07:31:35
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 MG/KG 100 200
MG/KG MG/KG
____________________________________________________________________________________________________________________________________
TUMOR SUMMARY
Total Animals with Primary Neoplasms (b) 45 44 42
Total Primary Neoplasms 67 76 69
Total Animals with Benign Neoplasms 27 36 35
Total Benign Neoplasms 32 51 43
Total Animals with Malignant Neoplasms 29 23 22
Total Malignant Neoplasms 35 25 26
Total Animals with Metastatic Neoplasms 5 5 6
Total Metastatic Neoplasm 8 6 13
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
Page 11
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