Incidence Rates Of Neoplasms By Anatomic Site
NTP Experiment-Test: 91014-04 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC OLEIC ACID DIETHANOLAMINE CONDENSATE Date: 09/23/97
Route: SKIN APPLICATION Time: 09:41:47
2 YEAR CHRONIC
Facility: Battelle Columbus Laboratory
Chemical CAS #: 93-83-4
Lock Date: 01/02/96
Cage Range: All
Reasons For Removal: 25022 Accidently Killed 25023 Missing
25019 Moribund Sacrifice 25020 Natural Death
25021 Terminal Sacrifice
Removal Date Range: All
Treatment Groups: Include 002 0 MG/KG
Include 004 15 MG/KG
Include 006 30 MG/KG
Include 001 0 MG/KG
Include 003 15 MG/KG
Include 005 30 MG/KG
a Number of animals examined microscopically at site and number of animals with lesion
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NTP Experiment-Test: 91014-04 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC OLEIC ACID DIETHANOLAMINE CONDENSATE Date: 09/23/97
Route: SKIN APPLICATION Time: 09:41:47
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 MG/KG 15 MG/KG 30 MG/KG
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially in Study 55 55 55
Early Deaths
Moribund Sacrifice 8 12 8
Natural Death 8 8 6
Accidently Killed 1
Survivors
Terminal Sacrifice 34 30 35
Animals Examined Microscopically 50 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Gallbladder (46) (46) (49)
Intestine Large, Colon (50) (50) (50)
Intestine Large, Cecum (50) (50) (50)
Leiomyoma 1 (2%)
Intestine Small, Jejunum (50) (49) (50)
Liver (50) (50) (50)
Hepatoblastoma 1 (2%)
Hepatocellular Carcinoma 4 (8%) 8 (16%) 7 (14%)
Hepatocellular Carcinoma, Multiple 1 (2%) 2 (4%)
Hepatocellular Adenoma 12 (24%) 13 (26%) 10 (20%)
Hepatocellular Adenoma, Multiple 14 (28%) 17 (34%) 18 (36%)
Histiocytic Sarcoma 3 (6%) 2 (4%) 1 (2%)
Ito Cell Tumor Benign, Multiple 1 (2%)
Mesentery (12) (7) (9)
Hemangioma 1 (11%)
Sarcoma 1 (8%)
Pancreas (49) (50) (50)
Histiocytic Sarcoma 1 (2%)
Salivary Glands (50) (50) (50)
Stomach, Forestomach (50) (50) (50)
Squamous Cell Carcinoma 1 (2%)
Squamous Cell Papilloma 2 (4%) 2 (4%) 4 (8%)
Squamous Cell Papilloma, Multiple 1 (2%)
Stomach, Glandular (50) (50) (50)
Sarcoma, Metastatic, Mesentery 1 (2%)
Tongue (1)
Squamous Cell Papilloma 1 (100%)
____________________________________________________________________________________________________________________________________
Page 2
NTP Experiment-Test: 91014-04 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC OLEIC ACID DIETHANOLAMINE CONDENSATE Date: 09/23/97
Route: SKIN APPLICATION Time: 09:41:47
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 MG/KG 15 MG/KG 30 MG/KG
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (50) (50) (50)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (50) (50) (50)
Adrenal Medulla (50) (50) (50)
Pheochromocytoma Benign 2 (4%)
Islets, Pancreatic (49) (50) (50)
Adenoma 1 (2%) 1 (2%)
Carcinoma 1 (2%)
Pituitary Gland (50) (50) (50)
Pars Distalis, Adenoma 9 (18%) 6 (12%) 3 (6%)
Pars Intermedia, Adenoma 3 (6%) 1 (2%)
Thyroid Gland (50) (50) (50)
Adenoma 1 (2%) 1 (2%)
Follicular Cell, Adenoma 2 (4%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Ovary (50) (50) (50)
Cystadenoma 3 (6%) 2 (4%)
Granulosa Cell Tumor Benign 1 (2%)
Hemangioma 1 (2%) 1 (2%)
Histiocytic Sarcoma 2 (4%)
Luteoma 1 (2%)
Teratoma Benign 2 (4%)
Periovarian Tissue, Plasma Cell Tumor
Malignant, Metastatic, Lymph Node,
Mesenteric 1 (2%)
Uterus (50) (50) (50)
Adenocarcinoma 1 (2%)
Hemangioma 2 (4%)
Histiocytic Sarcoma 2 (4%) 1 (2%)
Leiomyoma 1 (2%)
Polyp Stromal 1 (2%) 2 (4%)
Sarcoma Stromal 1 (2%)
Cervix, Histiocytic Sarcoma 1 (2%)
Vagina (1)
____________________________________________________________________________________________________________________________________
Page 3
NTP Experiment-Test: 91014-04 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC OLEIC ACID DIETHANOLAMINE CONDENSATE Date: 09/23/97
Route: SKIN APPLICATION Time: 09:41:47
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 MG/KG 15 MG/KG 30 MG/KG
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (50) (50) (50)
Hemangiosarcoma 1 (2%)
Histiocytic Sarcoma 1 (2%)
Lymph Node (2) (5) (8)
Lumbar, Histiocytic Sarcoma 1 (50%)
Renal, Fibrosarcoma, Metastatic, Skeletal
Muscle 1 (13%)
Lymph Node, Mandibular (49) (49) (47)
Hemangioma 1 (2%)
Plasma Cell Tumor Malignant, Metastatic,
Lymph Node, Mesenteric 1 (2%)
Lymph Node, Mesenteric (49) (47) (49)
Plasma Cell Tumor Malignant 1 (2%)
Spleen (50) (50) (50)
Histiocytic Sarcoma 1 (2%)
Thymus (41) (45) (47)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Skin (50) (50) (50)
Fibrosarcoma 1 (2%) 1 (2%) 2 (4%)
Histiocytic Sarcoma 1 (2%)
Pinna, Melanoma Malignant 1 (2%)
Skin, Site of Application, Fibrosarcoma 1 (2%) 2 (4%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (50) (50) (50)
Osteosarcoma 1 (2%)
Skeletal Muscle (1) (1)
Fibrosarcoma 1 (100%)
Osteosarcoma 1 (100%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (50) (50)
____________________________________________________________________________________________________________________________________
Page 4
NTP Experiment-Test: 91014-04 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC OLEIC ACID DIETHANOLAMINE CONDENSATE Date: 09/23/97
Route: SKIN APPLICATION Time: 09:41:47
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 MG/KG 15 MG/KG 30 MG/KG
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (50) (50)
Alveolar/Bronchiolar Adenoma 1 (2%) 1 (2%) 3 (6%)
Alveolar/Bronchiolar Adenoma, Multiple 1 (2%)
Alveolar/Bronchiolar Carcinoma 3 (6%) 2 (4%) 3 (6%)
Hepatocellular Carcinoma, Metastatic, Liver 3 (6%) 4 (8%) 6 (12%)
Histiocytic Sarcoma 1 (2%) 1 (2%)
Osteosarcoma, Metastatic, Uncertain Primary
Site 1 (2%)
Plasma Cell Tumor Malignant, Metastatic,
Lymph Node, Mesenteric 1 (2%)
Nose (50) (50) (50)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Harderian Gland (3) (2)
Adenoma 3 (100%) 1 (50%)
Carcinoma 1 (50%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (50) (50)
Histiocytic Sarcoma 1 (2%)
Plasma Cell Tumor Malignant, Metastatic,
Lymph Node, Mesenteric 1 (2%)
Urinary Bladder (50) (50) (50)
____________________________________________________________________________________________________________________________________
SYSTEMIC LESIONS
Multiple Organs *(50) *(50) *(50)
Histiocytic Sarcoma 3 (6%) 2 (4%) 1 (2%)
Leukemia Granulocytic 1 (2%)
Lymphoma Malignant 3 (6%) 9 (18%) 11 (22%)
____________________________________________________________________________________________________________________________________
* Number of animals with any tissue examined microscopically
Page 5
NTP Experiment-Test: 91014-04 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC OLEIC ACID DIETHANOLAMINE CONDENSATE Date: 09/23/97
Route: SKIN APPLICATION Time: 09:41:47
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 MG/KG 15 MG/KG 30 MG/KG
____________________________________________________________________________________________________________________________________
TUMOR SUMMARY
Total Animals with Primary Neoplasms (b) 46 45 36
Total Primary Neoplasms 77 86 72
Total Animals with Benign Neoplasms 37 40 31
Total Benign Neoplasms 53 56 46
Total Animals with Malignant Neoplasms 22 23 21
Total Malignant Neoplasms 24 30 26
Total Animals with Metastatic Neoplasms 4 5 8
Total Metastatic Neoplasm 4 5 11
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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NTP Experiment-Test: 91014-04 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC OLEIC ACID DIETHANOLAMINE CONDENSATE Date: 09/23/97
Route: SKIN APPLICATION Time: 09:41:47
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 MG/KG 15 MG/KG 30 MG/KG
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially in Study 55 55 55
Early Deaths
Moribund Sacrifice 3 8 11
Natural Death 5 7 5
Survivors
Terminal Sacrifice 41 35 34
Missing 1
Animals Examined Microscopically 49 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Intestine Small, Duodenum (48) (50) (50)
Hepatocholangiocarcinoma, Metastatic, Liver 1 (2%)
Intestine Small, Jejunum (49) (50) (50)
Carcinoma 2 (4%)
Hepatocholangiocarcinoma, Metastatic, Liver 2 (4%)
Intestine Small, Ileum (49) (50) (50)
Hepatocholangiocarcinoma, Metastatic, Liver 1 (2%)
Liver (49) (50) (50)
Fibrous Histiocytoma 1 (2%)
Hemangiosarcoma 2 (4%) 1 (2%)
Hemangiosarcoma, Multiple 1 (2%) 2 (4%) 1 (2%)
Hepatoblastoma 1 (2%)
Hepatocellular Carcinoma 5 (10%) 9 (18%) 12 (24%)
Hepatocellular Carcinoma, Multiple 4 (8%) 1 (2%)
Hepatocellular Adenoma 13 (27%) 14 (28%) 14 (28%)
Hepatocellular Adenoma, Multiple 9 (18%) 8 (16%) 8 (16%)
Hepatocholangiocarcinoma 2 (4%) 1 (2%)
Histiocytic Sarcoma 1 (2%)
Mesentery (4) (4) (3)
Fibrous Histiocytoma, Metastatic, Liver 1 (25%)
Pancreas (49) (50) (50)
Fibrous Histiocytoma, Metastatic, Liver 1 (2%)
Hepatocholangiocarcinoma, Metastatic, Liver 1 (2%)
Salivary Glands (49) (50) (50)
Fibrous Histiocytoma, Metastatic, Liver 1 (2%)
Stomach, Forestomach (49) (50) (50)
Squamous Cell Carcinoma 1 (2%)
Squamous Cell Papilloma 2 (4%)
Stomach, Glandular (49) (50) (50)
Adenoma 1 (2%)
____________________________________________________________________________________________________________________________________
Page 7
NTP Experiment-Test: 91014-04 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC OLEIC ACID DIETHANOLAMINE CONDENSATE Date: 09/23/97
Route: SKIN APPLICATION Time: 09:41:47
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 MG/KG 15 MG/KG 30 MG/KG
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Blood Vessel (49) (50) (50)
Fibrous Histiocytoma, Metastatic, Liver 1 (2%)
Heart (49) (50) (50)
Fibrous Histiocytoma, Metastatic, Liver 1 (2%)
Hemangiosarcoma, Metastatic, Spleen 1 (2%)
Hepatocholangiocarcinoma, Metastatic, Liver 1 (2%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (49) (50) (50)
Adenoma 2 (4%)
Hepatocholangiocarcinoma, Metastatic, Liver 1 (2%)
Adrenal Medulla (49) (50) (50)
Islets, Pancreatic (49) (50) (50)
Adenoma 2 (4%) 2 (4%)
Thyroid Gland (49) (50) (50)
Adenoma 1 (2%)
Follicular Cell, Adenoma 2 (4%) 1 (2%)
Follicular Cell, Carcinoma 1 (2%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Epididymis (49) (50) (50)
Alveolar/Bronchiolar Carcinoma, Metastatic,
Lung 1 (2%)
Preputial Gland (48) (50) (50)
Hemangioma 1 (2%)
Prostate (49) (50) (50)
Seminal Vesicle (49) (50) (50)
Testes (49) (50) (50)
Hemangioma 1 (2%)
Interstitial Cell, Adenoma 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
Page 8
NTP Experiment-Test: 91014-04 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC OLEIC ACID DIETHANOLAMINE CONDENSATE Date: 09/23/97
Route: SKIN APPLICATION Time: 09:41:47
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 MG/KG 15 MG/KG 30 MG/KG
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (49) (50) (50)
Fibrous Histiocytoma, Metastatic, Liver 1 (2%)
Hemangiosarcoma 2 (4%)
Hemangiosarcoma, Metastatic, Spleen 1 (2%)
Lymph Node (3) (4) (1)
Lumbar, Fibrous Histiocytoma, Metastatic,
Liver 1 (33%)
Mediastinal, Alveolar/Bronchiolar Carcinoma,
Metastatic, Lung 1 (25%)
Pancreatic, Hepatocellular Carcinoma,
Metastatic, Liver 1 (33%)
Renal, Fibrous Histiocytoma, Metastatic,
Liver 1 (33%)
Lymph Node, Mandibular (48) (46) (47)
Fibrous Histiocytoma, Metastatic, Liver 1 (2%)
Lymph Node, Mesenteric (47) (48) (48)
Spleen (49) (50) (50)
Hemangioma 1 (2%)
Hemangiosarcoma 3 (6%) 4 (8%) 2 (4%)
Hemangiosarcoma, Multiple 1 (2%)
Thymus (45) (36) (39)
Hemangioma 1 (3%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Skin (49) (50) (50)
Fibrosarcoma 1 (2%)
Fibrous Histiocytoma, Metastatic, Liver 1 (2%)
Hemangiosarcoma, Metastatic, Spleen 1 (2%)
Schwannoma Benign 1 (2%)
Subcutaneous Tissue, Hemangiosarcoma 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Skeletal Muscle (1)
Hepatocholangiocarcinoma, Metastatic, Liver 1 (100%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
None
____________________________________________________________________________________________________________________________________
Page 9
NTP Experiment-Test: 91014-04 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC OLEIC ACID DIETHANOLAMINE CONDENSATE Date: 09/23/97
Route: SKIN APPLICATION Time: 09:41:47
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 MG/KG 15 MG/KG 30 MG/KG
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (49) (50) (50)
Alveolar/Bronchiolar Adenoma 6 (12%) 8 (16%) 4 (8%)
Alveolar/Bronchiolar Adenoma, Multiple 1 (2%) 1 (2%)
Alveolar/Bronchiolar Carcinoma 6 (12%) 8 (16%) 9 (18%)
Alveolar/Bronchiolar Carcinoma, Multiple 1 (2%) 2 (4%)
Fibrous Histiocytoma, Metastatic, Liver 1 (2%)
Hemangiosarcoma, Metastatic, Spleen 1 (2%)
Hepatocellular Carcinoma, Metastatic, Liver 3 (6%) 2 (4%) 5 (10%)
Hepatocholangiocarcinoma, Metastatic, Liver 2 (4%) 3 (6%)
Mediastinum, Hemangioma 1 (2%)
Nose (49) (50) (50)
Fibrous Histiocytoma, Metastatic, Liver 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Harderian Gland (2) (1) (5)
Adenoma 2 (100%) 1 (100%) 4 (80%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (49) (50) (50)
Fibrous Histiocytoma, Metastatic, Liver 1 (2%)
Hepatocholangiocarcinoma, Metastatic, Liver 1 (2%)
Urinary Bladder (49) (50) (50)
Fibrous Histiocytoma, Metastatic, Liver 1 (2%)
Leiomyosarcoma 1 (2%)
____________________________________________________________________________________________________________________________________
SYSTEMIC LESIONS
Multiple Organs *(49) *(50) *(50)
Histiocytic Sarcoma 1 (2%)
Lymphoma Malignant 1 (2%) 6 (12%) 2 (4%)
____________________________________________________________________________________________________________________________________
* Number of animals with any tissue examined microscopically
Page 10
NTP Experiment-Test: 91014-04 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC OLEIC ACID DIETHANOLAMINE CONDENSATE Date: 09/23/97
Route: SKIN APPLICATION Time: 09:41:47
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 MG/KG 15 MG/KG 30 MG/KG
____________________________________________________________________________________________________________________________________
TUMOR SUMMARY
Total Animals with Primary Neoplasms (b) 42 43 44
Total Primary Neoplasms 61 77 74
Total Animals with Benign Neoplasms 28 30 32
Total Benign Neoplasms 35 39 40
Total Animals with Malignant Neoplasms 24 29 25
Total Malignant Neoplasms 26 38 34
Total Animals with Metastatic Neoplasms 5 6 9
Total Metastatic Neoplasm 18 16 11
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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