TDMS Study 56348-04 Pathology Tables
NTP Experiment-Test: 56348-04 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC CITRAL Date: 07/05/01 Route: DOSED FEED Time: 13:47:25 Facility: Battelle Columbus Laboratory Chemical CAS #: 5392-40-5 Lock Date: 03/25/99 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: 56348-04 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC CITRAL Date: 07/05/01 Route: DOSED FEED Time: 13:47:25 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE UNTREAT VEHICLE 500 PPM 1000 PPM 2000 PPM CONTROL CONTROL ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially in Study 50 50 50 50 50 Early Deaths Natural Death 5 3 3 3 5 Moribund Sacrifice 4 5 2 4 5 Accidently Killed 1 Survivors Terminal Sacrifice 40 41 45 43 40 Missing 1 Animals Examined Microscopically 50 49 50 50 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Rectum (50) (49) (50) (50) (50) Intestine Large, Cecum (50) (49) (50) (50) (50) Leiomyosarcoma 1 (2%) Intestine Small, Jejunum (50) (49) (50) (50) (50) Carcinoma 1 (2%) 1 (2%) Intestine Small, Ileum (50) (49) (50) (50) (50) Liver (50) (49) (50) (50) (50) Fibrous Histiocytoma 1 (2%) Hemangiosarcoma 1 (2%) Hepatocellular Carcinoma 1 (2%) 2 (4%) 1 (2%) 1 (2%) 1 (2%) Hepatocellular Carcinoma, Multiple 1 (2%) Hepatocellular Adenoma 5 (10%) 2 (4%) 2 (4%) 8 (16%) 7 (14%) Hepatocellular Adenoma, Multiple 1 (2%) 1 (2%) Histiocytic Sarcoma 1 (2%) Squamous Cell Carcinoma, Metastatic, Stomach, Forestomach 1 (2%) Mesentery (5) (3) (1) (6) (2) Fibrous Histiocytoma 1 (17%) Sarcoma, Metastatic, Skin 1 (17%) Pancreas (50) (49) (50) (50) (50) Salivary Glands (49) (49) (50) (50) (49) Stomach, Forestomach (50) (49) (50) (50) (50) Squamous Cell Carcinoma 1 (2%) Squamous Cell Papilloma 1 (2%) 2 (4%) Stomach, Glandular (50) (49) (50) (50) (50) Adenoma 1 (2%) Tongue (1) (1) Page 2 NTP Experiment-Test: 56348-04 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC CITRAL Date: 07/05/01 Route: DOSED FEED Time: 13:47:25 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE UNTREAT VEHICLE 500 PPM 1000 PPM 2000 PPM CONTROL CONTROL ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - cont Squamous Cell Carcinoma 1 (100%) 1 (100%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (50) (49) (50) (50) (50) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (50) (49) (50) (50) (50) Adrenal Medulla (50) (49) (50) (50) (50) Pheochromocytoma Malignant 1 (2%) Pituitary Gland (49) (48) (50) (49) (49) Pars Distalis, Adenoma 4 (8%) 4 (8%) 5 (10%) 2 (4%) 3 (6%) Pars Intermedia, Adenoma 1 (2%) 1 (2%) 1 (2%) Thyroid Gland (48) (49) (50) (50) (49) Follicle, Adenoma 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Clitoral Gland (47) (48) (50) (47) (49) Carcinoma 1 (2%) Ovary (50) (49) (50) (49) (50) Carcinoma, Metastatic, Stomach, Forestomach 1 (2%) Cystadenoma 1 (2%) 2 (4%) 1 (2%) 1 (2%) Granulosa Cell Tumor Benign 1 (2%) Histiocytic Sarcoma 1 (2%) Luteoma 1 (2%) Squamous Cell Carcinoma, Metastatic, Stomach, Forestomach 1 (2%) Uterus (50) (49) (50) (50) (50) Adenoma 1 (2%) Carcinoma 1 (2%) Leiomyosarcoma 1 (2%) Polyp Stromal 2 (4%) 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ Page 3 NTP Experiment-Test: 56348-04 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC CITRAL Date: 07/05/01 Route: DOSED FEED Time: 13:47:25 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE UNTREAT VEHICLE 500 PPM 1000 PPM 2000 PPM CONTROL CONTROL ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (50) (49) (50) (50) (50) Lymph Node (2) (1) (7) (5) Lumbar, Histiocytic Sarcoma 1 (20%) Mediastinal, Histiocytic Sarcoma 1 (20%) Mediastinal, Sarcoma, Metastatic, Skin 1 (14%) Renal, Histiocytic Sarcoma 1 (20%) Lymph Node, Mandibular (49) (49) (48) (47) (44) Histiocytic Sarcoma 1 (2%) Lymph Node, Mesenteric (49) (47) (48) (50) (49) Histiocytic Sarcoma 1 (2%) Squamous Cell Carcinoma, Metastatic, Stomach, Forestomach 1 (2%) Spleen (50) (49) (50) (49) (50) Histiocytic Sarcoma 1 (2%) Thymus (47) (48) (49) (48) (50) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (50) (49) (50) (49) (49) Carcinoma 1 (2%) Skin (50) (49) (50) (50) (50) Fibrous Histiocytoma 1 (2%) Sebaceous Gland, Adenoma 1 (2%) Subcutaneous Tissue, Hemangioma 1 (2%) Subcutaneous Tissue, Sarcoma 2 (4%) 2 (4%) 1 (2%) 2 (4%) Tail, Sarcoma 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (50) (49) (50) (50) (50) Fibrosarcoma 1 (2%) Skeletal Muscle (1) (1) (1) (2) Sarcoma 1 (100%) ____________________________________________________________________________________________________________________________________ Page 4 NTP Experiment-Test: 56348-04 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC CITRAL Date: 07/05/01 Route: DOSED FEED Time: 13:47:25 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE UNTREAT VEHICLE 500 PPM 1000 PPM 2000 PPM CONTROL CONTROL ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (48) (50) (50) (50) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (49) (50) (50) (50) Alveolar/Bronchiolar Adenoma 3 (6%) 2 (4%) 7 (14%) 3 (6%) 1 (2%) Alveolar/Bronchiolar Carcinoma 3 (6%) 3 (6%) 1 (2%) Carcinoma, Metastatic, Harderian Gland 1 (2%) Fibrous Histiocytoma 1 (2%) Hepatocellular Carcinoma, Metastatic, Liver 1 (2%) Histiocytic Sarcoma 1 (2%) Pheochromocytoma Malignant, Metastatic, Adrenal Medulla 1 (2%) Sarcoma, Metastatic, Skin 1 (2%) Nose (50) (49) (50) (50) (50) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Harderian Gland (2) (3) (2) (3) (1) Adenoma 1 (50%) 2 (67%) 1 (50%) 2 (67%) 1 (100%) Carcinoma 1 (50%) 1 (33%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (49) (50) (50) (50) Histiocytic Sarcoma 1 (2%) Urinary Bladder (50) (49) (50) (50) (50) ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS Multiple Organs *(50) *(49) *(50) *(50) *(50) Histiocytic Sarcoma 1 (2%) Lymphoma Malignant 4 (8%) 3 (6%) 5 (10%) 9 (18%) 12 (24%) ____________________________________________________________________________________________________________________________________ * Number of animals with any tissue examined microscopically Page 5 NTP Experiment-Test: 56348-04 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC CITRAL Date: 07/05/01 Route: DOSED FEED Time: 13:47:25 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE UNTREAT VEHICLE 500 PPM 1000 PPM 2000 PPM CONTROL CONTROL ____________________________________________________________________________________________________________________________________ TUMOR SUMMARY Total Animals with Primary Neoplasms (b) 23 22 27 23 30 Total Primary Neoplasms 32 28 36 34 36 Total Animals with Benign Neoplasms 16 12 19 13 14 Total Benign Neoplasms 19 16 22 16 17 Total Animals with Malignant Neoplasms 12 12 13 13 18 Total Malignant Neoplasms 13 12 14 18 19 Total Animals with Metastatic Neoplasms 2 2 2 Total Metastatic Neoplasm 2 2 6 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: 56348-04 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC CITRAL Date: 07/05/01 Route: DOSED FEED Time: 13:47:25 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE UNTREAT VEHICLE 500 PPM 1000 PPM 2000 PPM CONTROL CONTROL ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially in Study 50 50 50 50 50 Early Deaths Moribund Sacrifice 1 4 2 6 3 Natural Death 1 3 8 2 7 Survivors Terminal Sacrifice 47 42 40 42 40 Natural Death 1 Accidently Killed 1 Animals Examined Microscopically 50 50 50 50 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Small, Duodenum (50) (50) (50) (49) (50) Polyp Adenomatous 1 (2%) 1 (2%) Intestine Small, Jejunum (50) (50) (50) (50) (50) Carcinoma 1 (2%) 2 (4%) 1 (2%) Intestine Small, Ileum (50) (50) (50) (50) (50) Liver (50) (50) (50) (50) (50) Carcinoma, Metastatic, Pancreas 1 (2%) Hemangiosarcoma 2 (4%) Hepatocellular Carcinoma 3 (6%) 9 (18%) 12 (24%) 4 (8%) 9 (18%) Hepatocellular Carcinoma, Multiple 1 (2%) 1 (2%) 1 (2%) Hepatocellular Adenoma 9 (18%) 8 (16%) 8 (16%) 11 (22%) 10 (20%) Hepatocellular Adenoma, Multiple 1 (2%) 2 (4%) 3 (6%) 3 (6%) Mesentery (6) (3) (2) (3) (3) Pancreas (50) (50) (50) (50) (50) Carcinoma 1 (2%) Stomach, Forestomach (50) (50) (49) (50) (50) Carcinoma, Metastatic, Pancreas 1 (2%) Squamous Cell Papilloma 1 (2%) Stomach, Glandular (50) (50) (50) (50) (50) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (50) (50) (50) (50) (50) Hemangiosarcoma 1 (2%) Hepatocellular Carcinoma, Metastatic, Liver 1 (2%) ____________________________________________________________________________________________________________________________________ Page 7 NTP Experiment-Test: 56348-04 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC CITRAL Date: 07/05/01 Route: DOSED FEED Time: 13:47:25 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE UNTREAT VEHICLE 500 PPM 1000 PPM 2000 PPM CONTROL CONTROL ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (50) (50) (50) (50) (50) Subcapsular, Adenoma 1 (2%) 1 (2%) 1 (2%) Adrenal Medulla (49) (50) (50) (50) (50) Pheochromocytoma Benign 1 (2%) Islets, Pancreatic (50) (50) (50) (50) (50) Adenoma 1 (2%) Pituitary Gland (50) (48) (49) (47) (50) Pars Intermedia, Adenoma 1 (2%) Thyroid Gland (50) (50) (50) (50) (50) Follicular Cell, Adenoma 1 (2%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Epididymis (50) (50) (50) (50) (50) Carcinoma, Metastatic, Pancreas 1 (2%) Preputial Gland (50) (50) (50) (50) (50) Prostate (50) (50) (50) (50) (50) Seminal Vesicle (50) (50) (50) (50) (50) Carcinoma, Metastatic, Pancreas 1 (2%) Testes (50) (50) (50) (50) (50) Hemangioma 1 (2%) Hemangiosarcoma 1 (2%) Interstitial Cell, Adenoma 1 (2%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (50) (50) (50) (50) (50) Hemangiosarcoma 2 (4%) 1 (2%) Mast Cell Tumor Malignant 1 (2%) 1 (2%) Lymph Node (2) (1) (2) (1) Mediastinal, Carcinoma, Metastatic, Pancreas 1 (50%) Lymph Node, Mandibular (48) (45) (47) (47) (49) Lymph Node, Mesenteric (48) (47) (49) (48) (50) Spleen (50) (50) (49) (50) (50) Page 8 NTP Experiment-Test: 56348-04 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC CITRAL Date: 07/05/01 Route: DOSED FEED Time: 13:47:25 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE UNTREAT VEHICLE 500 PPM 1000 PPM 2000 PPM CONTROL CONTROL ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - cont Hemangiosarcoma 3 (6%) 2 (4%) Mast Cell Tumor Malignant 1 (2%) Thymus (50) (49) (48) (48) (46) Thymoma Benign 1 (2%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Skin (50) (50) (50) (50) (50) Pinna, Melanoma Malignant 1 (2%) Subcutaneous Tissue, Hemangioma 1 (2%) Subcutaneous Tissue, Sarcoma 1 (2%) Tail, Fibrosarcoma 1 (2%) 1 (2%) Tail, Neurofibrosarcoma 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (50) (50) (50) (50) (50) Chondrosarcoma 1 (2%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (50) (50) (50) (50) Astrocytoma Benign 1 (2%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (50) (50) (50) (50) Alveolar/Bronchiolar Adenoma 4 (8%) 8 (16%) 5 (10%) 6 (12%) 2 (4%) Alveolar/Bronchiolar Carcinoma 4 (8%) 5 (10%) 4 (8%) 1 (2%) 3 (6%) Carcinoma, Metastatic, Pancreas 1 (2%) Hemangiosarcoma 1 (2%) Hepatocellular Carcinoma, Metastatic, Liver 1 (2%) 1 (2%) 1 (2%) 2 (4%) ____________________________________________________________________________________________________________________________________ Page 9 NTP Experiment-Test: 56348-04 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC CITRAL Date: 07/05/01 Route: DOSED FEED Time: 13:47:25 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE UNTREAT VEHICLE 500 PPM 1000 PPM 2000 PPM CONTROL CONTROL ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Harderian Gland (2) (2) (1) (3) Adenoma 2 (100%) 2 (100%) 1 (100%) 2 (67%) Carcinoma 1 (33%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (50) (50) (50) (50) Urinary Bladder (50) (50) (49) (50) (50) Hemangioma 1 (2%) ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS Multiple Organs *(50) *(50) *(50) *(50) *(50) Lymphoma Malignant 4 (8%) 2 (4%) 3 (6%) 1 (2%) ____________________________________________________________________________________________________________________________________ * Number of animals with any tissue examined microscopically Page 10 NTP Experiment-Test: 56348-04 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC CITRAL Date: 07/05/01 Route: DOSED FEED Time: 13:47:25 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE UNTREAT VEHICLE 500 PPM 1000 PPM 2000 PPM CONTROL CONTROL ____________________________________________________________________________________________________________________________________ TUMOR SUMMARY Total Animals with Primary Neoplasms (b) 27 28 35 33 26 Total Primary Neoplasms 37 43 39 44 35 Total Animals with Benign Neoplasms 20 20 18 21 14 Total Benign Neoplasms 22 23 19 23 16 Total Animals with Malignant Neoplasms 14 18 20 17 18 Total Malignant Neoplasms 15 20 20 21 19 Total Animals with Metastatic Neoplasms 1 1 2 2 Total Metastatic Neoplasm 1 2 7 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 11 ------------------------------------------------------------ ---------- END OF REPORT ---------- ------------------------------------------------------------