INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)
DIHYDROCOUMARIN
NTP Experiment-Test: 05091-02 Report: PEIRPT05
Study Type: CHRONIC Date: 09/12/94
Route: GAVAGE Time: 13:00:29
Facility: American Biogenics Corp.
Chemical CAS #: 119-84-6
Lock Date: None
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: 05091-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC DIHYDROCOUMARIN Date: 09/12/94
Route: GAVAGE Time: 13:00:29
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE VEHICLE 200MG/KG 400MG/KG 800MG/KG
CONTROL
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially in Study 70 70 70 70
Scheduled Sacrifice 19 20 19 18
Early Deaths
Gavage Death 2
Moribund 5 9 4 5
Dead 8 2 5 18
Accident 1
Survivors
Terminal Sacrifice 36 39 41 28
Dead 1
Animals Examined Microscopically 60 56 58 61
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Gallbladder (54) (50) (44) (42)
Intestine Large, Cecum (53) (50) (46) (49)
Intestine Large, Colon (54) (50) (46) (49)
Intestine Small, Duodenum (54) (50) (46) (46)
Intestine Small, Ileum (54) (50) (45) (49)
Intestine Small, Jejunum (56) (50) (45) (48)
Liver (60) (50) (53) (61)
Hemangiosarcoma 2 (3%)
Hepatocellular Carcinoma 3 (5%) 2 (4%) 4 (8%) 6 (10%)
Hepatocellular Adenoma 12 (20%) 14 (28%) 14 (26%) 13 (21%)
Hepatocellular Adenoma, Multiple 6 (12%) 9 (17%) 9 (15%)
Histiocytic Sarcoma 1 (2%)
Neoplasm NOS 1 (2%)
Sarcoma, Metastatic, Uncertain Primary Site 1 (2%)
Hepatocyte, Hepatocellular Adenoma 1 (2%)
Pancreas (59) (50) (48) (56)
Sarcoma, Metastatic, Uncertain Primary Site 1 (2%)
Salivary Glands (60) (50) (50) (59)
Stomach, Forestomach (58) (50) (48) (57)
Squamous Cell Papilloma 2 (3%) 2 (4%) 1 (2%) 1 (2%)
Stomach, Glandular (53) (50) (45) (50)
____________________________________________________________________________________________________________________________________
Page 2
NTP Experiment-Test: 05091-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC DIHYDROCOUMARIN Date: 09/12/94
Route: GAVAGE Time: 13:00:29
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE VEHICLE 200MG/KG 400MG/KG 800MG/KG
CONTROL
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (59) (50) (50) (60)
Sarcoma, Metastatic, Uncertain Primary Site 1 (2%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Gland, Cortex (58) (50) (47) (57)
Sarcoma, Metastatic, Uncertain Primary Site 1 (2%)
Adrenal Gland, Medulla (56) (50) (47) (57)
Pheochromocytoma Benign 1 (2%)
Islets, Pancreatic (59) (50) (48) (56)
Adenoma 1 (2%)
Pituitary Gland (56) (48) (47) (56)
Pars Distalis, Adenoma 9 (16%) 5 (10%) 3 (6%) 3 (5%)
Thyroid Gland (57) (50) (49) (58)
Bilateral, Follicular Cell, Adenoma 1 (2%)
Follicular Cell, Adenoma 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
Tissue NOS (1) (1)
Fibroma 1 (100%)
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Clitoral Gland (2)
Carcinoma 1 (50%)
Ovary (59) (51) (50) (59)
Cystadenoma 1 (2%) 2 (4%) 1 (2%)
Granulosa Cell Tumor Benign 1 (2%)
Luteoma 1 (2%) 1 (2%)
Oviduct (2) (2)
Uterus (60) (56) (56) (60)
Polyp 2 (4%)
Sarcoma Stromal 1 (2%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (59) (50) (48) (56)
Lymph Node (59) (50) (48) (57)
Lumbar, Carcinoma, Metastatic, Clitoral Gland 1 (2%)
Lymph Node, Mandibular (57) (48) (40) (51)
Lymph Node, Mesenteric (56) (50) (45) (49)
Page 3
NTP Experiment-Test: 05091-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC DIHYDROCOUMARIN Date: 09/12/94
Route: GAVAGE Time: 13:00:29
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE VEHICLE 200MG/KG 400MG/KG 800MG/KG
CONTROL
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - cont
Spleen (60) (50) (49) (55)
Hemangiosarcoma 2 (4%)
Sarcoma, Metastatic, Uncertain Primary Site 1 (2%)
Thymus (54) (48) (47) (57)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (60) (47) (48) (59)
Adenoma 1 (2%)
Skin (60) (52) (50) (60)
Sarcoma, Metastatic, Uncertain Primary Site 1 (2%)
Subcutaneous Tissue, Fibrosarcoma 1 (2%) 1 (2%)
Subcutaneous Tissue, Hemangioma 1 (2%)
Subcutaneous Tissue, Hemangiosarcoma 1 (2%)
Subcutaneous Tissue, Schwannoma Malignant 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (60) (50) (50) (61)
Osteosarcoma 1 (2%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (58) (50) (47) (57)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (60) (50) (48) (60)
Alveolar/Bronchiolar Adenoma 2 (3%) 5 (10%) 1 (2%) 3 (5%)
Alveolar/Bronchiolar Carcinoma 1 (2%)
Hepatocellular Carcinoma, Metastatic, Liver 2 (3%) 1 (2%)
Osteosarcoma, Metastatic, Bone 1 (2%)
Sarcoma, Metastatic, Uncertain Primary Site 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Harderian Gland (2) (3) (3) (1)
Adenoma 1 (50%) 3 (100%) 3 (100%) 1 (100%)
____________________________________________________________________________________________________________________________________
Page 4
NTP Experiment-Test: 05091-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC DIHYDROCOUMARIN Date: 09/12/94
Route: GAVAGE Time: 13:00:29
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE VEHICLE 200MG/KG 400MG/KG 800MG/KG
CONTROL
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (57) (50) (48) (56)
Sarcoma, Metastatic, Uncertain Primary Site 1 (2%)
Ureter (1)
Urinary Bladder (54) (50) (47) (54)
____________________________________________________________________________________________________________________________________
SYSTEMIC LESIONS
Multiple Organs *(60) *(56) *(58) *(61)
Histiocytic Sarcoma 1 (2%)
Lymphoma Malignant 1 (2%) 3 (5%) 3 (5%)
Lymphoma Malignant Histiocytic 1 (2%)
Lymphoma Malignant Lymphocytic 1 (2%) 4 (7%) 4 (7%) 2 (3%)
Lymphoma Malignant Mixed 1 (2%) 2 (4%) 1 (2%)
Lymphoma Malignant Undifferentiated Cell 2 (3%)
____________________________________________________________________________________________________________________________________
* Number of animals with any tissue examined microscopically
Page 5
NTP Experiment-Test: 05091-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC DIHYDROCOUMARIN Date: 09/12/94
Route: GAVAGE Time: 13:00:29
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE VEHICLE 200MG/KG 400MG/KG 800MG/KG
CONTROL
____________________________________________________________________________________________________________________________________
TUMOR SUMMARY
Total Animals with Primary Neoplasms (b) 26 36 38 40
Total Primary Neoplasms 40 55 49 50
Total Animals with Benign Neoplasms 19 29 29 27
Total Benign Neoplasms 29 42 37 32
Total Animals with Malignant Neoplasms 9 11 11 16
Total Malignant Neoplasms 11 13 11 18
Total Animals with Metastatic Neoplasms 2 3 1
Total Metastatic Neoplasm 2 3 8
Total Animals with Malignant Neoplasms 1
Uncertain Primary Site
Total Animals with Neoplasms Uncertain-
Benign or Malignant 1
Total Uncertain Neoplasms 1
____________________________________________________________________________________________________________________________________
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: 05091-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC DIHYDROCOUMARIN Date: 09/12/94
Route: GAVAGE Time: 13:00:29
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE VEHICLE 200MG/KG 400MG/KG 800MG/KG
CONTROL
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially in Study 70 70 70 70
Scheduled Sacrifice 20 19 19 20
Early Deaths
Gavage Death 1 1 1
Dead 4 8 8 8
Moribund 3 3 8 4
Survivors
Terminal Sacrifice 42 39 34 38
Animals Examined Microscopically 60 58 56 60
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Intestine Large, Cecum (57) (46) (43) (54)
Intestine Small, Ileum (57) (46) (43) (54)
Adenocarcinoma 1 (2%) 1 (2%)
Intestine Small, Jejunum (57) (45) (43) (54)
Adenocarcinoma 2 (4%)
Adenoma 1 (2%)
Sarcoma 1 (2%)
Liver (60) (56) (55) (60)
Hemangiosarcoma 1 (2%)
Hemangiosarcoma, Multiple 1 (2%)
Hepatoblastoma 2 (3%)
Hepatocellular Carcinoma 10 (17%) 11 (20%) 11 (20%) 6 (10%)
Hepatocellular Carcinoma, Multiple 1 (2%)
Hepatocellular Adenoma 24 (40%) 22 (39%) 19 (35%) 15 (25%)
Hepatocellular Adenoma, Multiple 8 (13%) 5 (9%) 19 (35%) 19 (32%)
Hepatocholangiocarcinoma 1 (2%)
Histiocytic Sarcoma 1 (2%)
Mesentery (3) (3) (2) (1)
Hemangioma 1 (33%)
Pancreas (58) (50) (48) (59)
Stomach, Forestomach (59) (49) (46) (58)
Squamous Cell Carcinoma 1 (2%) 1 (2%) 2 (3%)
Squamous Cell Papilloma 2 (3%) 5 (11%) 2 (3%)
Stomach, Glandular (58) (47) (43) (56)
Squamous Cell Carcinoma, Metastatic 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
Page 7
NTP Experiment-Test: 05091-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC DIHYDROCOUMARIN Date: 09/12/94
Route: GAVAGE Time: 13:00:29
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE VEHICLE 200MG/KG 400MG/KG 800MG/KG
CONTROL
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (60) (51) (51) (60)
Alveolar/Bronchiolar Carcinoma, Metastatic,
Lung 1 (2%) 1 (2%)
Hemangiosarcoma, Metastatic, Spleen 1 (2%)
Hepatocellular Carcinoma, Metastatic, Liver 1 (2%)
Sarcoma 1 (2%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Gland (60) (50) (48) (59)
Spindle Cell, Adenoma 1 (2%)
Adrenal Gland, Cortex (59) (50) (48) (59)
Alveolar/Bronchiolar Carcinoma, Metastatic,
Lung 1 (2%)
Adrenal Gland, Medulla (59) (49) (48) (57)
Alveolar/Bronchiolar Carcinoma, Metastatic,
Lung 1 (2%)
Islets, Pancreatic (59) (50) (49) (60)
Adenoma 2 (4%)
Pituitary Gland (56) (46) (45) (55)
Pars Distalis, Adenoma 1 (2%) 1 (2%)
Thyroid Gland (59) (49) (49) (60)
Follicular Cell, Adenoma 1 (2%) 2 (3%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
Tissue NOS (1) (5) (1)
Liposarcoma 1 (100%)
Thoracic, Hemangioma 1 (20%)
Thoracic, Hepatocellular Carcinoma,
Metastatic, Liver 1 (20%)
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Epididymis (59) (49) (48) (59)
Alveolar/Bronchiolar Carcinoma, Metastatic,
Lung 1 (2%)
Squamous Cell Carcinoma, Metastatic, Stomach 1 (2%)
Seminal Vesicle (59) (48) (47) (58)
Testes (59) (48) (48) (58)
Interstitial Cell, Adenoma 1 (2%)
____________________________________________________________________________________________________________________________________
Page 8
NTP Experiment-Test: 05091-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC DIHYDROCOUMARIN Date: 09/12/94
Route: GAVAGE Time: 13:00:29
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE VEHICLE 200MG/KG 400MG/KG 800MG/KG
CONTROL
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (59) (51) (50) (59)
Histiocytic Sarcoma 1 (2%)
Lymph Node (60) (49) (51) (60)
Bronchial, Sarcoma 1 (2%)
Bronchial, Squamous Cell Carcinoma,
Metastatic 1 (2%)
Mediastinal, Alveolar/Bronchiolar Carcinoma,
Metastatic, Lung 1 (2%)
Mediastinal, Hepatocellular Carcinoma,
Metastatic, Liver 1 (2%)
Mediastinal, Hepatocholangiocarcinoma,
Metastatic, Liver 1 (2%)
Mediastinal, Sarcoma 1 (2%)
Lymph Node, Mandibular (56) (41) (49) (54)
Lymph Node, Mesenteric (59) (48) (44) (57)
Spleen (59) (50) (47) (58)
Hemangioma 1 (2%)
Hemangiosarcoma 1 (2%) 1 (2%) 2 (3%)
Histiocytic Sarcoma 1 (2%)
Thymus (51) (49) (39) (56)
Alveolar/Bronchiolar Carcinoma, Metastatic,
Lung 1 (2%) 1 (2%)
Hepatocellular Carcinoma, Metastatic, Liver 1 (2%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Skin (59) (50) (49) (58)
Hepatocholangiocarcinoma, Metastatic, Liver 1 (2%)
Subcutaneous Tissue, Hemangioma 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (60) (51) (51) (60)
Alveolar/Bronchiolar Carcinoma, Metastatic,
Lung 1 (2%) 1 (2%)
Hepatocholangiocarcinoma, Metastatic, Liver 1 (2%)
Skeletal Muscle (1) (2)
Alveolar/Bronchiolar Carcinoma, Metastatic,
Lung 1 (100%)
Diaphragm, Alveolar/Bronchiolar Carcinoma,
Metastatic, Lung 1 (50%)
____________________________________________________________________________________________________________________________________
Page 9
NTP Experiment-Test: 05091-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC DIHYDROCOUMARIN Date: 09/12/94
Route: GAVAGE Time: 13:00:29
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE VEHICLE 200MG/KG 400MG/KG 800MG/KG
CONTROL
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
None
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (60) (52) (53) (60)
Adenocarcinoma, Metastatic, Harderian Gland 1 (2%)
Alveolar/Bronchiolar Adenoma 8 (13%) 15 (29%) 13 (25%) 11 (18%)
Alveolar/Bronchiolar Adenoma, Multiple 1 (2%) 1 (2%) 4 (8%)
Alveolar/Bronchiolar Carcinoma 1 (2%) 2 (4%) 1 (2%) 3 (5%)
Alveolar/Bronchiolar Carcinoma, Multiple 1 (2%)
Hepatocellular Carcinoma, Metastatic, Liver 1 (2%) 3 (6%) 2 (4%) 1 (2%)
Hepatocholangiocarcinoma, Metastatic, Liver 1 (2%)
Liposarcoma, Metastatic, Tissue NOS 1 (2%)
Neoplasm NOS, Metastatic, Liver 1 (2%)
Nose (60) (51) (50) (60)
Histiocytic Sarcoma 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (3) (3) (2) (2)
Adenocarcinoma, Metastatic, Harderian Gland 1 (33%)
Harderian Gland (5) (5) (2) (2)
Adenocarcinoma 1 (20%)
Adenoma 5 (100%) 4 (80%) 2 (100%) 2 (100%)
Lacrimal Gland (1) (1) (1)
Adenoma 1 (100%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (60) (51) (51) (59)
Alveolar/Bronchiolar Carcinoma, Metastatic,
Lung 1 (2%) 1 (2%)
Hepatocellular Carcinoma, Metastatic 1 (2%)
Hepatocellular Carcinoma, Metastatic, Liver 1 (2%)
Hepatocholangiocarcinoma, Metastatic, Liver 1 (2%)
Histiocytic Sarcoma 1 (2%)
Squamous Cell Carcinoma, Metastatic, Stomach 1 (2%)
Renal Tubule, Adenoma 2 (4%)
Page 10
NTP Experiment-Test: 05091-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC DIHYDROCOUMARIN Date: 09/12/94
Route: GAVAGE Time: 13:00:29
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE VEHICLE 200MG/KG 400MG/KG 800MG/KG
CONTROL
____________________________________________________________________________________________________________________________________
URINARY SYSTEM - cont
Renal Tubule, Carcinoma 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
SYSTEMIC LESIONS
Multiple Organs *(60) *(58) *(56) *(60)
Histiocytic Sarcoma 1 (2%)
Lymphoma Malignant 3 (5%) 3 (5%)
Lymphoma Malignant Histiocytic 1 (2%)
Lymphoma Malignant Lymphocytic 1 (2%)
Lymphoma Malignant Mixed 1 (2%)
____________________________________________________________________________________________________________________________________
* Number of animals with any tissue examined microscopically
Page 11
NTP Experiment-Test: 05091-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC DIHYDROCOUMARIN Date: 09/12/94
Route: GAVAGE Time: 13:00:29
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE VEHICLE 200MG/KG 400MG/KG 800MG/KG
CONTROL
____________________________________________________________________________________________________________________________________
TUMOR SUMMARY
Total Animals with Primary Neoplasms (b) 46 46 48 47
Total Primary Neoplasms 72 69 89 75
Total Animals with Benign Neoplasms 39 36 43 40
Total Benign Neoplasms 52 51 67 53
Total Animals with Malignant Neoplasms 17 17 16 20
Total Malignant Neoplasms 20 18 22 22
Total Animals with Metastatic Neoplasms 4 5 2 5
Total Metastatic Neoplasm 11 16 2 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 12
------------------------------------------------------------
---------- END OF REPORT ----------
------------------------------------------------------------