NTP Experiment-Test: 05162-10 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC DIETHANOLAMINE Date: 06/11/96
Route: SKIN APPLICATION Time: 11:55:25
CORE STUDY
Facility: Battelle Columbus Laboratory
Chemical CAS #: 111-42-2
Lock Date: 06/04/93
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: 05162-10 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC DIETHANOLAMINE Date: 06/11/96
Route: SKIN APPLICATION Time: 11:55:25
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 MG/KG 40 MG/KG 80 MG/KG 160
MG/KG
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially in Study 50 50 50 50
Early Deaths
Natural Death 2 9 8 14
Moribund Sacrifice 4 8 9 13
Survivors
Terminal Sacrifice 44 33 33 22
Natural Death 1
Animals Examined Microscopically 50 50 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Intestine Small, Jejunum (50) (50) (50) (49)
Fibrosarcoma, Metastatic, Mesentery 1 (2%)
Liver (50) (50) (50) (50)
Fibrosarcoma, Metastatic, Mesentery 1 (2%)
Hemangioma 1 (2%)
Hepatoblastoma 2 (4%) 1 (2%) 1 (2%)
Hepatocellular Carcinoma 5 (10%) 13 (26%) 17 (34%) 16 (32%)
Hepatocellular Carcinoma, Multiple 6 (12%) 21 (42%) 26 (52%)
Hepatocellular Adenoma 16 (32%) 7 (14%) 2 (4%) 3 (6%)
Hepatocellular Adenoma, Multiple 16 (32%) 43 (86%) 46 (92%) 45 (90%)
Histiocytic Sarcoma 1 (2%) 1 (2%) 1 (2%)
Mesentery (4) (5) (1) (2)
Fat, Fibrosarcoma 1 (20%)
Pancreas (50) (50) (50) (49)
Histiocytic Sarcoma 1 (2%)
Salivary Glands (50) (50) (50) (50)
Stomach, Forestomach (50) (50) (50) (49)
Squamous Cell Papilloma 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
None
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (50) (50) (50) (50)
Capsule, Adenoma 1 (2%)
Adrenal Medulla (50) (50) (50) (50)
Pheochromocytoma Benign 2 (4%) 1 (2%)
Islets, Pancreatic (50) (50) (50) (49)
Page 2
NTP Experiment-Test: 05162-10 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC DIETHANOLAMINE Date: 06/11/96
Route: SKIN APPLICATION Time: 11:55:25
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 MG/KG 40 MG/KG 80 MG/KG 160
MG/KG
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM - cont
Adenoma 1 (2%)
Pituitary Gland (50) (50) (47) (44)
Pars Distalis, Adenoma 7 (14%) 3 (6%) 1 (2%)
Pars Intermedia, Adenoma 1 (2%)
Thyroid Gland (50) (50) (50) (49)
Follicular Cell, Adenoma 3 (6%) 8 (16%) 7 (14%) 3 (6%)
Follicular Cell, Adenoma, Multiple 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
Tissue NOS (1)
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Clitoral Gland (46) (48) (46) (43)
Ovary (49) (50) (49) (49)
Cystadenoma 2 (4%)
Granulosa-Theca Tumor Benign 1 (2%)
Hemangioma 3 (6%) 1 (2%)
Teratoma Benign 1 (2%)
Teratoma Malignant 1 (2%)
Periovarian Tissue, Histiocytic Sarcoma 1 (2%)
Uterus (50) (50) (50) (50)
Adenoma 1 (2%)
Fibrosarcoma, Metastatic, Mesentery 1 (2%)
Polyp Stromal 3 (6%) 2 (4%) 2 (4%)
Cervix, Histiocytic Sarcoma 1 (2%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (50) (50) (50) (50)
Hemangiosarcoma 1 (2%)
Histiocytic Sarcoma 1 (2%)
Mast Cell Tumor Malignant 1 (2%)
Lymph Node (9) (2) (5)
Inguinal, Sarcoma 1 (11%)
Mediastinal, Fibrosarcoma, Metastatic,
Mesentery 1 (50%)
Renal, Fibrous Histiocytoma 1 (20%)
Lymph Node, Mandibular (46) (48) (46) (43)
Carcinoma, Metastatic, Harderian Gland 1 (2%)
Histiocytic Sarcoma 2 (5%)
Mast Cell Tumor Malignant 1 (2%)
Lymph Node, Mesenteric (48) (48) (44) (40)
Page 3
NTP Experiment-Test: 05162-10 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC DIETHANOLAMINE Date: 06/11/96
Route: SKIN APPLICATION Time: 11:55:25
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 MG/KG 40 MG/KG 80 MG/KG 160
MG/KG
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - cont
Fibrosarcoma, Metastatic, Mesentery 1 (2%)
Histiocytic Sarcoma 1 (3%)
Spleen (50) (50) (50) (50)
Hemangiosarcoma 2 (4%)
Histiocytic Sarcoma 2 (4%)
Capsule, Fibrosarcoma, Metastatic, Mesentery 1 (2%)
Thymus (48) (42) (41) (36)
Histiocytic Sarcoma 1 (3%)
Mast Cell Tumor Malignant 1 (2%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (49) (47) (47) (40)
Carcinoma 1 (2%) 2 (4%)
Skin (50) (50) (50) (50)
Subcutaneous Tissue, Fibrosarcoma 2 (4%) 1 (2%)
Subcutaneous Tissue, Hemangioma 1 (2%)
Subcutaneous Tissue, Hemangiosarcoma 1 (2%)
Subcutaneous Tissue, Sebaceous Gland,
Squamous Cell Carcinoma 1 (2%)
Subcutaneous Tissue, Pinna, Fibroma 1 (2%)
Subcutaneous Tissue, Skin, Site of
Application, Fibrosarcoma 1 (2%)
Subcutaneous Tissue, Skin, Site of
Application, Sarcoma 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Skeletal Muscle (1) (1)
Fibrosarcoma, Metastatic, Skin 1 (100%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (50) (50) (50)
Meninges, Mast Cell Tumor Malignant 1 (2%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (50) (50) (50)
Alveolar/Bronchiolar Adenoma 4 (8%) 1 (2%) 2 (4%) 1 (2%)
Alveolar/Bronchiolar Carcinoma 2 (4%) 1 (2%) 2 (4%)
Carcinoma, Metastatic, Harderian Gland 1 (2%)
Carcinoma, Metastatic, Mammary Gland 1 (2%)
Page 4
NTP Experiment-Test: 05162-10 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC DIETHANOLAMINE Date: 06/11/96
Route: SKIN APPLICATION Time: 11:55:25
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 MG/KG 40 MG/KG 80 MG/KG 160
MG/KG
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM - cont
Hepatocellular Carcinoma, Metastatic, Liver 3 (6%) 6 (12%) 1 (2%)
Histiocytic Sarcoma 1 (2%)
Mediastinum, Alveolar/Bronchiolar Carcinoma,
Metastatic, Lung 1 (2%)
Mediastinum, Fibrosarcoma, Metastatic, Skin 1 (2%)
Nose (50) (50) (49) (50)
Histiocytic Sarcoma 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Harderian Gland (1) (2) (1) (3)
Adenoma 1 (100%) 1 (50%) 1 (100%) 2 (67%)
Carcinoma 1 (50%) 1 (33%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (50) (50) (50)
Urinary Bladder (50) (49) (50) (48)
Fibrosarcoma, Metastatic, Mesentery 1 (2%)
____________________________________________________________________________________________________________________________________
SYSTEMIC LESIONS
Multiple Organs *(50) *(50) *(50) *(50)
Histiocytic Sarcoma 1 (2%) 1 (2%) 2 (4%)
Lymphoma Malignant 12 (24%) 6 (12%) 11 (22%) 2 (4%)
____________________________________________________________________________________________________________________________________
* Number of animals with any tissue examined microscopically
Page 5
NTP Experiment-Test: 05162-10 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC DIETHANOLAMINE Date: 06/11/96
Route: SKIN APPLICATION Time: 11:55:25
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 MG/KG 40 MG/KG 80 MG/KG 160
MG/KG
____________________________________________________________________________________________________________________________________
TUMOR SUMMARY
Total Animals with Primary Neoplasms (b) 47 50 50 50
Total Primary Neoplasms 90 98 128 107
Total Animals with Benign Neoplasms 40 50 49 48
Total Benign Neoplasms 62 64 68 58
Total Animals with Malignant Neoplasms 22 26 44 44
Total Malignant Neoplasms 28 34 60 49
Total Animals with Metastatic Neoplasms 8 6 1
Total Metastatic Neoplasm 15 7 1
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: 05162-10 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC DIETHANOLAMINE Date: 06/11/96
Route: SKIN APPLICATION Time: 11:55:25
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 MG/KG 40 MG/KG 80 MG/KG 160
MG/KG
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially in Study 50 50 50 50
Early Deaths
Natural Death 7 6 10 9
Moribund Sacrifice 3 1 6 10
Accidently Killed 1
Survivors
Terminal Sacrifice 40 41 34 30
Natural Death 2
Animals Examined Microscopically 50 50 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Intestine Small, Jejunum (50) (49) (50) (50)
Carcinoma 3 (6%)
Liver (50) (50) (50) (50)
Hemangiosarcoma 2 (4%)
Hemangiosarcoma, Multiple 1 (2%)
Hepatoblastoma 2 (4%) 8 (16%) 5 (10%)
Hepatocellular Carcinoma 10 (20%) 12 (24%) 19 (38%) 17 (34%)
Hepatocellular Carcinoma, Multiple 2 (4%) 5 (10%) 14 (28%) 17 (34%)
Hepatocellular Adenoma 19 (38%) 6 (12%) 2 (4%) 4 (8%)
Hepatocellular Adenoma, Multiple 12 (24%) 36 (72%) 47 (94%) 41 (82%)
Osteosarcoma, Metastatic, Bone 1 (2%)
Stomach, Forestomach (50) (49) (50) (50)
Squamous Cell Carcinoma 1 (2%)
Squamous Cell Papilloma 1 (2%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (50) (50) (50) (50)
Carcinoma, Metastatic, Islets, Pancreatic 1 (2%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (50) (50) (50) (50)
Adenoma 1 (2%)
Capsule, Adenoma 5 (10%) 8 (16%) 1 (2%) 2 (4%)
Islets, Pancreatic (50) (50) (50) (50)
Carcinoma 1 (2%)
Pituitary Gland (48) (47) (46) (43)
Pars Intermedia, Adenoma 1 (2%) 2 (5%)
Page 7
NTP Experiment-Test: 05162-10 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC DIETHANOLAMINE Date: 06/11/96
Route: SKIN APPLICATION Time: 11:55:25
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 MG/KG 40 MG/KG 80 MG/KG 160
MG/KG
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM - cont
Thyroid Gland (50) (49) (50) (50)
Follicular Cell, Adenoma 4 (8%) 5 (10%) 4 (8%) 2 (4%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Epididymis (50) (50) (50) (50)
Leiomyoma 1 (2%)
Testes (50) (50) (50) (50)
Interstitial Cell, Adenoma 2 (4%) 2 (4%) 2 (4%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (50) (50) (50) (50)
Hemangiosarcoma 1 (2%) 1 (2%) 1 (2%)
Lymph Node (1) (2) (1)
Mediastinal, Plasma Cell Tumor Malignant 1 (100%)
Lymph Node, Mandibular (46) (46) (44) (36)
Lymph Node, Mesenteric (45) (43) (41) (41)
Plasma Cell Tumor Malignant 1 (2%)
Spleen (50) (50) (50) (50)
Hemangiosarcoma 1 (2%) 4 (8%)
Plasma Cell Tumor Malignant 1 (2%)
Thymus (37) (42) (39) (36)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Skin (50) (50) (50) (50)
Subcutaneous Tissue, Fibroma 1 (2%) 1 (2%)
Subcutaneous Tissue, Fibrosarcoma 1 (2%) 1 (2%)
Subcutaneous Tissue, Hemangiosarcoma 1 (2%) 1 (2%)
Subcutaneous Tissue, Lipoma 1 (2%)
Subcutaneous Tissue, Pinna, Fibroma 1 (2%)
Subcutaneous Tissue, Skin, Site of
Application, Lymphoma Malignant 1 (2%)
Subcutaneous Tissue, Skin, Site of
Application, Osteosarcoma, Metastatic,
Bone 1 (2%)
____________________________________________________________________________________________________________________________________
Page 8
NTP Experiment-Test: 05162-10 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC DIETHANOLAMINE Date: 06/11/96
Route: SKIN APPLICATION Time: 11:55:25
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 MG/KG 40 MG/KG 80 MG/KG 160
MG/KG
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (50) (50) (50) (50)
Rib, Carcinoma, Metastatic, Islets,
Pancreatic 1 (2%)
Vertebra, Osteosarcoma 1 (2%)
Skeletal Muscle (2) (3)
Hemangiosarcoma 1 (50%)
Hepatoblastoma, Metastatic, Liver 1 (33%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
None
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (50) (50) (50)
Alveolar/Bronchiolar Adenoma 9 (18%) 13 (26%) 9 (18%) 4 (8%)
Alveolar/Bronchiolar Adenoma, Multiple 2 (4%) 2 (4%) 1 (2%)
Alveolar/Bronchiolar Carcinoma 5 (10%) 1 (2%) 3 (6%)
Hepatoblastoma, Metastatic, Liver 2 (4%) 3 (6%)
Hepatocellular Carcinoma, Metastatic, Liver 3 (6%) 4 (8%) 7 (14%) 4 (8%)
Osteosarcoma, Metastatic, Bone 1 (2%)
Mediastinum, Carcinoma, Metastatic, Islets,
Pancreatic 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Harderian Gland (1) (2) (1)
Adenoma 1 (100%) 2 (100%)
Carcinoma 1 (100%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (50) (50) (50)
Hemangiosarcoma 1 (2%)
Renal Tubule, Adenoma 1 (2%) 4 (8%) 4 (8%) 6 (12%)
Renal Tubule, Adenoma, Multiple 2 (4%)
Renal Tubule, Carcinoma 2 (4%) 1 (2%) 2 (4%)
Page 9
NTP Experiment-Test: 05162-10 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC DIETHANOLAMINE Date: 06/11/96
Route: SKIN APPLICATION Time: 11:55:25
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 MG/KG 40 MG/KG 80 MG/KG 160
MG/KG
____________________________________________________________________________________________________________________________________
SYSTEMIC LESIONS
Multiple Organs *(50) *(50) *(50) *(50)
Lymphoma Malignant 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
* Number of animals with any tissue examined microscopically
Page 10
NTP Experiment-Test: 05162-10 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC DIETHANOLAMINE Date: 06/11/96
Route: SKIN APPLICATION Time: 11:55:25
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 MG/KG 40 MG/KG 80 MG/KG 160
MG/KG
____________________________________________________________________________________________________________________________________
TUMOR SUMMARY
Total Animals with Primary Neoplasms (b) 46 49 50 49
Total Primary Neoplasms 85 106 128 109
Total Animals with Benign Neoplasms 38 45 49 45
Total Benign Neoplasms 57 77 76 64
Total Animals with Malignant Neoplasms 21 22 38 35
Total Malignant Neoplasms 28 29 52 45
Total Animals with Metastatic Neoplasms 4 4 9 8
Total Metastatic Neoplasm 6 4 10 10
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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