TDMS Study 88035-06 Pathology Tables
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 ------------------------------------------------------------ ---------- END OF REPORT ---------- ------------------------------------------------------------