NTP Experiment-Test: 88035-06 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC PRIMACLONE Date: 12/30/96
Route: DOSED FEED Time: 16:43:08
Facility: Battelle Columbus Laboratory
Chemical CAS #: 0000125-33-7
Lock Date: 11/17/94
Cage Range: All
Reasons For Removal: All
Removal Date Range: All
Treatment Groups: Merge 001 001 0 PPM
Merge 002 002 0 PPM
Merge 003 003 300 PPM
Merge 004 004 300 PPM
Merge 005 005 600 PPM
Merge 006 006 600 PPM
Merge 007 007 1300 PPM
Merge 008 008 1300 PPM
a Number of animals examined microscopically at site and number of animals with lesion
Page 1
NTP Experiment-Test: 88035-06 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC PRIMACLONE Date: 12/30/96
Route: DOSED FEED Time: 16:43:08
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 PPM 300 PPM 600 PPM 1300 PPM
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially in Study 50 50 50 50
Early Deaths
Natural Death 2 7 2 3
Moribund Sacrifice 7 1 3 8
Survivors
Terminal Sacrifice 41 42 44 39
Missing 1
Animals Examined Microscopically 50 50 49 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Esophagus (50) (50) (49) (50)
Squamous Cell Carcinoma 1 (2%)
Intestine Small, Jejunum (50) (49) (49) (50)
Intestine Small, Ileum (45) (49) (49) (49)
Liver (50) (50) (49) (50)
Fibrosarcoma, Metastatic, Skin 1 (2%)
Hemangiosarcoma 1 (2%)
Hepatoblastoma 1 (2%) 3 (6%) 3 (6%) 4 (8%)
Hepatoblastoma, Multiple 1 (2%) 1 (2%)
Hepatocellular Carcinoma 3 (6%) 7 (14%) 14 (29%) 13 (26%)
Hepatocellular Carcinoma, Multiple 4 (8%) 5 (10%) 25 (50%)
Hepatocellular Adenoma 8 (16%) 5 (10%) 6 (12%) 5 (10%)
Hepatocellular Adenoma, Multiple 7 (14%) 37 (74%) 39 (80%) 42 (84%)
Histiocytic Sarcoma 2 (4%) 1 (2%)
Mesentery (5) (5) (6) (2)
Histiocytic Sarcoma 1 (17%)
Pancreas (50) (48) (49) (50)
Salivary Glands (50) (48) (49) (50)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
None
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (50) (49) (49) (50)
Capsule, Adenoma 1 (2%)
Islets, Pancreatic (50) (47) (49) (50)
Adenoma 1 (2%) 1 (2%)
Pituitary Gland (49) (48) (49) (48)
Page 2
NTP Experiment-Test: 88035-06 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC PRIMACLONE Date: 12/30/96
Route: DOSED FEED Time: 16:43:08
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 PPM 300 PPM 600 PPM 1300 PPM
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM - cont
Histiocytic Sarcoma 1 (2%)
Pars Distalis, Adenoma 3 (6%) 5 (10%) 6 (12%) 6 (13%)
Pars Intermedia, Adenoma 1 (2%)
Thyroid Gland (50) (48) (48) (50)
Follicular Cell, Adenoma 1 (2%) 1 (2%) 2 (4%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Ovary (49) (49) (48) (50)
Cystadenoma 3 (6%) 2 (4%) 1 (2%)
Hemangiosarcoma 1 (2%)
Histiocytic Sarcoma 1 (2%) 1 (2%)
Uterus (50) (49) (49) (50)
Histiocytic Sarcoma 1 (2%) 1 (2%)
Polyp Stromal 1 (2%) 3 (6%) 1 (2%) 1 (2%)
Sarcoma Stromal 1 (2%)
Cervix, Histiocytic Sarcoma 1 (2%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (50) (49) (49) (50)
Hemangioma 1 (2%)
Histiocytic Sarcoma 1 (2%)
Lymph Node (6) (8) (7) (4)
Deep Cervical, Alveolar/Bronchiolar
Carcinoma, Metastatic, Lung 1 (13%)
Lumbar, Histiocytic Sarcoma 1 (13%)
Renal, Histiocytic Sarcoma 1 (13%)
Lymph Node, Mandibular (48) (44) (45) (46)
Histiocytic Sarcoma 1 (2%) 1 (2%)
Lymph Node, Mesenteric (48) (48) (47) (47)
Histiocytic Sarcoma 1 (2%) 1 (2%)
Spleen (50) (48) (49) (50)
Hemangiosarcoma 1 (2%)
Histiocytic Sarcoma 1 (2%) 1 (2%)
Thymus (45) (47) (44) (44)
Fibrosarcoma, Metastatic, Skin 1 (2%)
Histiocytic Sarcoma 1 (2%)
____________________________________________________________________________________________________________________________________
Page 3
NTP Experiment-Test: 88035-06 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC PRIMACLONE Date: 12/30/96
Route: DOSED FEED Time: 16:43:08
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 PPM 300 PPM 600 PPM 1300 PPM
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (50) (50) (49) (47)
Carcinoma 1 (2%)
Skin (50) (50) (49) (50)
Subcutaneous Tissue, Fibrosarcoma 3 (6%) 2 (4%) 1 (2%) 2 (4%)
Subcutaneous Tissue, Hemangiosarcoma 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (50) (50) (49) (50)
Maxilla, Carcinoma, Metastatic, Harderian
Gland 1 (2%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
None
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (50) (49) (50)
Alveolar/Bronchiolar Adenoma 4 (8%) 2 (4%) 3 (6%) 2 (4%)
Alveolar/Bronchiolar Adenoma, Multiple 1 (2%)
Alveolar/Bronchiolar Carcinoma 4 (8%) 3 (6%) 1 (2%)
Fibrosarcoma, Metastatic, Skin 1 (2%) 1 (2%) 1 (2%)
Hepatoblastoma, Metastatic, Liver 1 (2%) 1 (2%)
Hepatocellular Carcinoma, Metastatic, Liver 1 (2%)
Histiocytic Sarcoma 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Harderian Gland (5) (5) (3) (1)
Adenoma 3 (60%) 5 (100%) 3 (100%) 1 (100%)
Carcinoma 2 (40%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (49) (49) (50)
Urinary Bladder (50) (49) (48) (49)
Histiocytic Sarcoma 1 (2%)
Page 4
NTP Experiment-Test: 88035-06 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC PRIMACLONE Date: 12/30/96
Route: DOSED FEED Time: 16:43:08
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 PPM 300 PPM 600 PPM 1300 PPM
____________________________________________________________________________________________________________________________________
SYSTEMIC LESIONS
Multiple Organs *(50) *(50) *(49) *(50)
Histiocytic Sarcoma 2 (4%) 1 (2%)
Lymphoma Malignant 8 (16%) 6 (12%) 8 (16%) 5 (10%)
____________________________________________________________________________________________________________________________________
* Number of animals with any tissue examined microscopically
Page 5
NTP Experiment-Test: 88035-06 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC PRIMACLONE Date: 12/30/96
Route: DOSED FEED Time: 16:43:08
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 PPM 300 PPM 600 PPM 1300 PPM
____________________________________________________________________________________________________________________________________
TUMOR SUMMARY
Total Animals with Primary Neoplasms (b) 34 47 47 50
Total Primary Neoplasms 57 89 97 111
Total Animals with Benign Neoplasms 26 45 46 47
Total Benign Neoplasms 32 59 62 61
Total Animals with Malignant Neoplasms 20 23 26 40
Total Malignant Neoplasms 25 30 35 50
Total Animals with Metastatic Neoplasms 3 2 1 2
Total Metastatic Neoplasm 3 2 3 2
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: 88035-06 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC PRIMACLONE Date: 12/30/96
Route: DOSED FEED Time: 16:43:08
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 PPM 300 PPM 600 PPM 1300 PPM
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially in Study 50 50 50 50
Early Deaths
Moribund Sacrifice 6 7 6 17
Natural Death 9 9 13 14
Survivors
Terminal Sacrifice 35 33 31 19
Natural Death 1
Animals Examined Microscopically 50 50 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Intestine Large, Rectum (48) (49) (50) (47)
Fibrous Histiocytoma 1 (2%)
Intestine Small, Jejunum (46) (49) (50) (47)
Histiocytic Sarcoma 1 (2%)
Intestine Small, Ileum (42) (47) (49) (48)
Histiocytic Sarcoma 1 (2%)
Liver (50) (50) (50) (50)
Hemangiosarcoma 2 (4%) 3 (6%)
Hepatoblastoma 15 (30%) 21 (42%) 6 (12%)
Hepatoblastoma, Multiple 2 (4%) 5 (10%) 1 (2%)
Hepatocellular Carcinoma 10 (20%) 21 (42%) 13 (26%) 19 (38%)
Hepatocellular Carcinoma, Multiple 2 (4%) 10 (20%) 22 (44%) 19 (38%)
Hepatocellular Adenoma 16 (32%) 12 (24%) 5 (10%) 10 (20%)
Hepatocellular Adenoma, Multiple 6 (12%) 29 (58%) 34 (68%) 22 (44%)
Histiocytic Sarcoma 4 (8%)
Mast Cell Tumor Malignant 1 (2%)
Mesentery (1) (2) (1) (1)
Fat, Histiocytic Sarcoma 1 (100%)
Pancreas (46) (48) (50) (47)
Hemangioma 1 (2%)
Hepatoblastoma, Metastatic, Liver 1 (2%)
Stomach, Forestomach (50) (49) (50) (49)
Squamous Cell Carcinoma 1 (2%)
Squamous Cell Papilloma 1 (2%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
None
____________________________________________________________________________________________________________________________________
Page 7
NTP Experiment-Test: 88035-06 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC PRIMACLONE Date: 12/30/96
Route: DOSED FEED Time: 16:43:08
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 PPM 300 PPM 600 PPM 1300 PPM
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (50) (49) (50) (50)
Histiocytic Sarcoma 1 (2%)
Capsule, Adenoma 1 (2%) 1 (2%)
Adrenal Medulla (50) (49) (50) (50)
Pheochromocytoma Benign 1 (2%) 1 (2%)
Islets, Pancreatic (45) (48) (49) (47)
Adenoma 1 (2%)
Thyroid Gland (49) (48) (50) (50)
Follicular Cell, Adenoma 3 (6%) 3 (6%) 6 (12%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Epididymis (50) (50) (50) (50)
Hepatoblastoma, Metastatic, Liver 1 (2%)
Prostate (49) (50) (50) (50)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (50) (50) (50) (50)
Mast Cell Tumor Malignant 1 (2%)
Lymph Node (1) (4) (1) (3)
Mediastinal, Alveolar/Bronchiolar Carcinoma,
Metastatic, Lung 1 (25%)
Lymph Node, Mesenteric (48) (48) (49) (42)
Histiocytic Sarcoma 1 (2%)
Spleen (48) (49) (50) (49)
Hemangiosarcoma 2 (4%)
Hepatoblastoma, Metastatic, Uncertain
Primary Site 1 (2%)
Histiocytic Sarcoma 2 (4%)
Mast Cell Tumor Malignant 1 (2%)
Thymus (42) (40) (42) (34)
____________________________________________________________________________________________________________________________________
Page 8
NTP Experiment-Test: 88035-06 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC PRIMACLONE Date: 12/30/96
Route: DOSED FEED Time: 16:43:08
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 PPM 300 PPM 600 PPM 1300 PPM
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Skin (50) (50) (50) (50)
Subcutaneous Tissue, Fibrous Histiocytoma 1 (2%)
Subcutaneous Tissue, Histiocytic Sarcoma 1 (2%) 1 (2%)
Subcutaneous Tissue, Mast Cell Tumor
Malignant 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Skeletal Muscle (1)
Hepatoblastoma, Metastatic, Liver 1 (100%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
None
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (50) (50) (50)
Alveolar/Bronchiolar Adenoma 6 (12%) 7 (14%) 5 (10%) 5 (10%)
Alveolar/Bronchiolar Adenoma, Multiple 1 (2%) 1 (2%)
Alveolar/Bronchiolar Carcinoma 4 (8%) 1 (2%) 1 (2%) 3 (6%)
Alveolar/Bronchiolar Carcinoma, Multiple 1 (2%)
Carcinoma, Metastatic, Harderian Gland 1 (2%)
Hepatoblastoma, Metastatic, Liver 2 (4%) 11 (22%) 5 (10%)
Hepatocellular Carcinoma, Metastatic, Liver 5 (10%) 5 (10%) 4 (8%) 5 (10%)
Histiocytic Sarcoma 1 (2%)
Mast Cell Tumor Malignant 1 (2%)
Sarcoma, Metastatic, Uncertain Primary Site 1 (2%)
Mediastinum, Hepatoblastoma, Metastatic,
Liver 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Harderian Gland (2) (3) (1) (2)
Adenoma 2 (100%) 2 (67%) 1 (100%) 1 (50%)
Carcinoma 1 (33%)
____________________________________________________________________________________________________________________________________
Page 9
NTP Experiment-Test: 88035-06 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC PRIMACLONE Date: 12/30/96
Route: DOSED FEED Time: 16:43:08
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 PPM 300 PPM 600 PPM 1300 PPM
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (49) (50) (50)
Alveolar/Bronchiolar Carcinoma, Metastatic,
Lung 1 (2%) 1 (2%)
Hepatoblastoma, Metastatic, Liver 1 (2%)
Histiocytic Sarcoma 1 (2%)
Renal Tubule, Carcinoma 1 (2%)
____________________________________________________________________________________________________________________________________
SYSTEMIC LESIONS
Multiple Organs *(50) *(50) *(50) *(50)
Histiocytic Sarcoma 1 (2%) 5 (10%)
Lymphoma Malignant 7 (14%) 4 (8%) 2 (4%)
____________________________________________________________________________________________________________________________________
* Number of animals with any tissue examined microscopically
Page 10
NTP Experiment-Test: 88035-06 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC PRIMACLONE Date: 12/30/96
Route: DOSED FEED Time: 16:43:08
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 PPM 300 PPM 600 PPM 1300 PPM
____________________________________________________________________________________________________________________________________
TUMOR SUMMARY
Total Animals with Primary Neoplasms (b) 40 50 50 47
Total Primary Neoplasms 68 112 115 101
Total Animals with Benign Neoplasms 26 42 39 36
Total Benign Neoplasms 34 54 50 46
Total Animals with Malignant Neoplasms 22 42 42 42
Total Malignant Neoplasms 34 58 65 55
Total Animals with Metastatic Neoplasms 5 9 14 11
Total Metastatic Neoplasm 6 11 20 11
Total Animals with Malignant Neoplasms 1 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
Page 11
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