TDMS Study 88035-05 Pathology Tables
NTP Experiment-Test: 88035-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC PRIMACLONE Date: 10/01/96 Route: DOSED FEED Time: 10:21:25 CORE STUDY 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: Include All a Number of animals examined microscopically at site and number of animals with lesion Page 1 NTP Experiment-Test: 88035-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC PRIMACLONE Date: 10/01/96 Route: DOSED FEED Time: 10:21:25 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0.0% 0.06% 0.13% 0.25% ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially in Study 50 50 50 50 Early Deaths Moribund Sacrifice 21 18 14 19 Natural Death 5 5 5 3 Survivors Terminal Sacrifice 24 27 31 27 Natural Death 1 Animals Examined Microscopically 50 50 50 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Colon (50) (50) (50) (50) Intestine Large, Cecum (49) (50) (50) (49) Fibrosarcoma, Metastatic, Spleen 1 (2%) Intestine Small, Duodenum (49) (50) (50) (50) Intestine Small, Jejunum (49) (50) (50) (49) Fibrosarcoma, Metastatic, Spleen 1 (2%) Intestine Small, Ileum (50) (50) (50) (49) Fibrosarcoma, Metastatic, Spleen 1 (2%) Liver (50) (50) (50) (50) Fibrosarcoma, Metastatic, Spleen 1 (2%) Hepatocellular Adenoma 1 (2%) 1 (2%) Mesentery (9) (10) (7) (7) Fibrosarcoma, Metastatic, Spleen 1 (14%) Oral Mucosa (2) Gingival, Squamous Cell Carcinoma 1 (50%) Pharyngeal, Squamous Cell Carcinoma 1 (50%) Pancreas (49) (50) (50) (50) Fibrosarcoma, Metastatic, Spleen 1 (2%) Salivary Glands (49) (50) (50) (50) Stomach, Forestomach (49) (50) (50) (50) Stomach, Glandular (49) (50) (50) (50) Carcinoid Tumor Benign 1 (2%) Carcinoid Tumor Malignant 1 (2%) Fibrosarcoma, Metastatic, Spleen 1 (2%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Blood Vessel (49) (50) (50) (50) Heart (49) (50) (50) (50) Schwannoma Malignant 1 (2%) ____________________________________________________________________________________________________________________________________ Page 2 NTP Experiment-Test: 88035-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC PRIMACLONE Date: 10/01/96 Route: DOSED FEED Time: 10:21:25 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0.0% 0.06% 0.13% 0.25% ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (50) (50) (50) (50) Adenoma 1 (2%) 2 (4%) 1 (2%) Thymoma Malignant, Metastatic, Thymus 1 (2%) Adrenal Medulla (50) (50) (49) (50) Pheochromocytoma Benign 2 (4%) 2 (4%) 3 (6%) Islets, Pancreatic (50) (50) (50) (50) Adenoma 1 (2%) Parathyroid Gland (38) (44) (42) (39) Pituitary Gland (49) (50) (49) (50) Pars Distalis, Adenoma 16 (33%) 20 (40%) 13 (27%) 18 (36%) Pars Distalis, Adenoma, Multiple 1 (2%) 1 (2%) 2 (4%) Pars Distalis, Carcinoma 1 (2%) Thyroid Gland (49) (50) (50) (50) Bilateral, C-Cell, Adenoma 1 (2%) C-Cell, Adenoma 5 (10%) 2 (4%) 6 (12%) 4 (8%) Follicular Cell, Carcinoma 1 (2%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Clitoral Gland (49) (49) (50) (50) Adenoma 4 (8%) 1 (2%) 4 (8%) 1 (2%) Carcinoma 1 (2%) 1 (2%) 2 (4%) Ovary (50) (50) (50) (49) Granulosa-Theca Tumor Malignant 1 (2%) Uterus (50) (50) (50) (49) Leiomyosarcoma 1 (2%) Polyp Stromal 7 (14%) 7 (14%) 6 (12%) 7 (14%) Polyp Stromal, Multiple 1 (2%) Sarcoma Stromal 3 (6%) 3 (6%) Vagina (1) (1) (2) Polyp 1 (100%) 2 (100%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (50) (50) (50) (50) Lymph Node (11) (7) (8) (12) Thoracic, Carcinoma, Metastatic, Mammary Gland 1 (13%) Page 3 NTP Experiment-Test: 88035-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC PRIMACLONE Date: 10/01/96 Route: DOSED FEED Time: 10:21:25 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0.0% 0.06% 0.13% 0.25% ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - cont Lymph Node, Mandibular (49) (50) (50) (50) Lymph Node, Mesenteric (50) (50) (50) (49) Spleen (49) (50) (50) (50) Fibrosarcoma 1 (2%) Thymus (49) (45) (47) (46) Thymoma Benign 1 (2%) Thymoma Malignant 1 (2%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (50) (50) (50) (50) Adenoma 2 (4%) Carcinoma 1 (2%) 2 (4%) 1 (2%) Fibroadenoma 13 (26%) 21 (42%) 14 (28%) 11 (22%) Fibroadenoma, Multiple 9 (18%) 4 (8%) 2 (4%) 1 (2%) Skin (50) (50) (50) (50) Basal Cell Carcinoma 1 (2%) Pinna, Squamous Cell Papilloma 1 (2%) Subcutaneous Tissue, Fibroma 1 (2%) 1 (2%) 1 (2%) Subcutaneous Tissue, Fibrosarcoma 1 (2%) 1 (2%) 1 (2%) 2 (4%) Subcutaneous Tissue, Liposarcoma 1 (2%) Subcutaneous Tissue, Sarcoma 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Skeletal Muscle (1) (2) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (50) (50) (50) Astrocytoma Malignant 1 (2%) 1 (2%) Carcinoma, Metastatic, Pituitary Gland 1 (2%) Spinal Cord (1) (2) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (49) (50) (50) (50) Alveolar/Bronchiolar Adenoma 1 (2%) 2 (4%) Carcinoma, Metastatic, Mammary Gland 1 (2%) Thymoma Malignant, Metastatic, Thymus 1 (2%) Trachea (49) (50) (50) (50) ____________________________________________________________________________________________________________________________________ Page 4 NTP Experiment-Test: 88035-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC PRIMACLONE Date: 10/01/96 Route: DOSED FEED Time: 10:21:25 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0.0% 0.06% 0.13% 0.25% ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Zymbal's Gland (1) (1) Carcinoma 1 (100%) 1 (100%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (50) (50) (50) Urinary Bladder (50) (50) (50) (49) ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS Multiple Organs *(50) *(50) *(50) *(50) Leukemia Mononuclear 13 (26%) 13 (26%) 13 (26%) 22 (44%) ____________________________________________________________________________________________________________________________________ * Number of animals with any tissue examined microscopically Page 5 NTP Experiment-Test: 88035-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC PRIMACLONE Date: 10/01/96 Route: DOSED FEED Time: 10:21:25 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0.0% 0.06% 0.13% 0.25% ____________________________________________________________________________________________________________________________________ TUMOR SUMMARY Total Animals with Primary Neoplasms (b) 47 44 41 46 Total Primary Neoplasms 86 81 72 88 Total Animals with Benign Neoplasms 39 35 35 33 Total Benign Neoplasms 63 60 53 54 Total Animals with Malignant Neoplasms 21 20 17 28 Total Malignant Neoplasms 23 21 19 34 Total Animals with Metastatic Neoplasms 1 1 2 Total Metastatic Neoplasm 2 2 8 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: 88035-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC PRIMACLONE Date: 10/01/96 Route: DOSED FEED Time: 10:21:25 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0.0% 0.06% 0.13% 0.25% ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially in Study 50 50 50 50 Early Deaths Moribund Sacrifice 33 33 39 36 Natural Death 4 10 7 14 Survivors Terminal Sacrifice 13 7 4 Animals Examined Microscopically 50 50 50 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Colon (50) (50) (49) (46) Polyp Adenomatous 1 (2%) Intestine Small, Duodenum (50) (50) (50) (47) Intestine Small, Jejunum (50) (50) (49) (45) Carcinoma 1 (2%) Leiomyosarcoma 1 (2%) Intestine Small, Ileum (50) (50) (49) (46) Leiomyosarcoma 1 (2%) Liver (50) (50) (50) (50) Fibrosarcoma, Metastatic, Spleen 1 (2%) Hepatocellular Adenoma 1 (2%) 1 (2%) Hepatocellular Adenoma, Multiple 1 (2%) 1 (2%) Mesentery (11) (6) (9) (3) Fat, Fibrosarcoma, Metastatic, Spleen 1 (9%) Oral Mucosa (1) Pharyngeal, Squamous Cell Carcinoma 1 (100%) Pancreas (50) (50) (50) (49) Salivary Glands (50) (50) (49) (49) Stomach, Forestomach (50) (50) (50) (49) Squamous Cell Papilloma 1 (2%) Stomach, Glandular (50) (50) (50) (49) Tongue (1) Squamous Cell Papilloma 1 (100%) Tooth (1) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (50) (50) (50) (50) ____________________________________________________________________________________________________________________________________ Page 7 NTP Experiment-Test: 88035-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC PRIMACLONE Date: 10/01/96 Route: DOSED FEED Time: 10:21:25 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0.0% 0.06% 0.13% 0.25% ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (50) (50) (50) (50) Adrenal Medulla (50) (50) (50) (49) Pheochromocytoma Malignant 1 (2%) 1 (2%) 1 (2%) Pheochromocytoma Benign 16 (32%) 19 (38%) 19 (38%) 7 (14%) Bilateral, Pheochromocytoma Benign 7 (14%) 9 (18%) 5 (10%) 5 (10%) Islets, Pancreatic (50) (50) (50) (49) Adenoma 1 (2%) Carcinoma 1 (2%) Parathyroid Gland (45) (41) (46) (49) Pituitary Gland (49) (50) (48) (49) Pars Distalis, Adenoma 17 (35%) 12 (24%) 11 (23%) 4 (8%) Pars Intermedia, Adenoma 1 (2%) 1 (2%) 1 (2%) Thyroid Gland (50) (50) (49) (49) Bilateral, C-Cell, Adenoma 1 (2%) C-Cell, Adenoma 7 (14%) 2 (4%) 7 (14%) 1 (2%) C-Cell, Carcinoma 1 (2%) 1 (2%) Follicular Cell, Adenoma 1 (2%) 1 (2%) 6 (12%) 3 (6%) Follicular Cell, Carcinoma 1 (2%) 3 (6%) 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM Peritoneum (1) (1) (1) Tissue NOS (1) ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Coagulating Gland (2) (1) (1) Epididymis (50) (50) (50) (48) Preputial Gland (50) (50) (50) (49) Adenoma 2 (4%) 1 (2%) 2 (4%) Carcinoma 1 (2%) Prostate (50) (50) (50) (48) Seminal Vesicle (50) (50) (50) (48) Testes (50) (50) (50) (48) Bilateral, Interstitial Cell, Adenoma 33 (66%) 33 (66%) 35 (70%) 34 (71%) Interstitial Cell, Adenoma 8 (16%) 11 (22%) 7 (14%) 9 (19%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (50) (50) (50) (50) Lymph Node (24) (23) (16) (10) Lymph Node, Mandibular (50) (50) (48) (49) Lymph Node, Mesenteric (50) (50) (50) (48) Page 8 NTP Experiment-Test: 88035-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC PRIMACLONE Date: 10/01/96 Route: DOSED FEED Time: 10:21:25 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0.0% 0.06% 0.13% 0.25% ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - cont Spleen (50) (50) (50) (49) Fibrosarcoma 3 (6%) 1 (2%) Thymus (49) (47) (44) (46) Thymoma Malignant 1 (2%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (48) (49) (50) (47) Adenoma 1 (2%) Carcinoma 2 (4%) Fibroadenoma 3 (6%) 3 (6%) 3 (6%) Skin (50) (50) (50) (50) Basal Cell Adenoma 1 (2%) Basal Cell Carcinoma 1 (2%) Basosquamous Tumor Benign 1 (2%) Keratoacanthoma 1 (2%) 1 (2%) Trichoepithelioma 1 (2%) Pinna, Melanoma Malignant 1 (2%) Pinna, Squamous Cell Papilloma 1 (2%) 1 (2%) 1 (2%) Subcutaneous Tissue, Fibroma 3 (6%) 3 (6%) 3 (6%) Subcutaneous Tissue, Fibrosarcoma 2 (4%) Subcutaneous Tissue, Hemangiosarcoma 1 (2%) Subcutaneous Tissue, Pinna, Melanoma Benign 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (50) (50) (50) (50) Chordoma 1 (2%) Mandible, Osteosarcoma 1 (2%) Tibia, Osteosarcoma 1 (2%) Skeletal Muscle (1) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (50) (49) (49) Astrocytoma Malignant 2 (4%) Peripheral Nerve (1) (1) Spinal, Schwannoma Malignant 1 (100%) ____________________________________________________________________________________________________________________________________ Page 9 NTP Experiment-Test: 88035-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC PRIMACLONE Date: 10/01/96 Route: DOSED FEED Time: 10:21:25 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0.0% 0.06% 0.13% 0.25% ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (50) (50) (50) Alveolar/Bronchiolar Adenoma 1 (2%) 1 (2%) Alveolar/Bronchiolar Carcinoma 1 (2%) 1 (2%) Chordoma, Metastatic, Bone 1 (2%) Fibrosarcoma, Metastatic, Spleen 1 (2%) Hemangiosarcoma, Metastatic, Skin 1 (2%) Osteosarcoma, Metastatic, Bone 1 (2%) Squamous Cell Carcinoma 1 (2%) Nose (50) (50) (50) (50) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Zymbal's Gland (1) Carcinoma 1 (100%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (50) (50) (50) Fibrosarcoma, Metastatic, Spleen 1 (2%) Lipoma 1 (2%) Osteosarcoma, Metastatic, Bone 1 (2%) Renal Tubule, Adenoma 2 (4%) 1 (2%) 1 (2%) 1 (2%) Renal Tubule, Carcinoma 1 (2%) Urinary Bladder (50) (50) (50) (48) Papilloma 1 (2%) ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS Multiple Organs *(50) *(50) *(50) *(50) Leukemia Mononuclear 35 (70%) 30 (60%) 24 (48%) 12 (24%) Lymphoma Malignant 1 (2%) Mesothelioma Malignant 2 (4%) 3 (6%) 2 (4%) 1 (2%) ____________________________________________________________________________________________________________________________________ * Number of animals with any tissue examined microscopically Page 10 NTP Experiment-Test: 88035-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC PRIMACLONE Date: 10/01/96 Route: DOSED FEED Time: 10:21:25 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0.0% 0.06% 0.13% 0.25% ____________________________________________________________________________________________________________________________________ TUMOR SUMMARY Total Animals with Primary Neoplasms (b) 50 49 50 47 Total Primary Neoplasms 160 144 143 87 Total Animals with Benign Neoplasms 49 49 49 44 Total Benign Neoplasms 105 103 107 69 Total Animals with Malignant Neoplasms 41 35 29 15 Total Malignant Neoplasms 55 41 36 18 Total Animals with Metastatic Neoplasms 3 1 Total Metastatic Neoplasm 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 11 ------------------------------------------------------------ ---------- END OF REPORT ---------- ------------------------------------------------------------