TDMS Study 88122-06 Pathology Tables
NTP Experiment-Test: 88122-06 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC ELMIRON Date: 06/12/01 Route: GAVAGE Time: 09:18:08 FINAL#1 Facility: Battelle Columbus Laboratory Chemical CAS #: 37319-17-8 Lock Date: 06/01/00 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: 88122-06 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC ELMIRON Date: 06/12/01 Route: GAVAGE Time: 09:18:08 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 MG/KG 28 MG/KG 84 MG/KG 252 MG/KG ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially in Study 50 50 50 50 Early Deaths Natural Death 13 10 9 6 Moribund Sacrifice 6 8 11 11 Dosing Accident 1 2 5 Accidently Killed 1 1 Survivors Natural Death 1 Terminal Sacrifice 30 31 28 26 Animals Examined Microscopically 50 50 50 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Rectum (46) (43) (44) (42) Leiomyosarcoma, Metastatic, Vagina 1 (2%) Liver (50) (50) (50) (50) Fibrous Histiocytoma 1 (2%) Hepatocellular Carcinoma 1 (2%) Leiomyosarcoma, Metastatic, Uterus 1 (2%) Mesentery (8) (4) (6) (9) Liposarcoma 1 (13%) Pancreas (50) (50) (50) (50) Adenoma 1 (2%) Salivary Glands (50) (50) (50) (50) Stomach, Forestomach (50) (50) (50) (50) Stomach, Glandular (50) (50) (50) (50) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (50) (50) (50) (50) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (50) (50) (50) (50) Adenoma 1 (2%) Adrenal Medulla (50) (50) (50) (50) Pheochromocytoma Benign 2 (4%) 1 (2%) 3 (6%) Page 2 NTP Experiment-Test: 88122-06 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC ELMIRON Date: 06/12/01 Route: GAVAGE Time: 09:18:08 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 MG/KG 28 MG/KG 84 MG/KG 252 MG/KG ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM - cont Bilateral, Pheochromocytoma Malignant 1 (2%) Islets, Pancreatic (50) (50) (50) (50) Adenoma 1 (2%) 2 (4%) Parathyroid Gland (46) (44) (46) (45) Adenoma 1 (2%) Pituitary Gland (50) (50) (50) (50) Pars Distalis, Adenoma 21 (42%) 21 (42%) 26 (52%) 19 (38%) Pars Intermedia, Adenoma 1 (2%) Thyroid Gland (50) (50) (50) (50) Bilateral, C-Cell, Adenoma 1 (2%) C-Cell, Adenoma 11 (22%) 7 (14%) 9 (18%) 9 (18%) C-Cell, Adenoma, Multiple 1 (2%) Follicle, Carcinoma 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Clitoral Gland (50) (50) (50) (49) Adenoma 3 (6%) 4 (8%) Ovary (50) (50) (50) (50) Granulosa Cell Tumor Malignant 1 (2%) Uterus (50) (50) (50) (50) Adenocarcinoma 1 (2%) Leiomyoma 1 (2%) Leiomyosarcoma 1 (2%) Polyp Stromal 7 (14%) 8 (16%) 7 (14%) 5 (10%) Sarcoma Stromal 1 (2%) Endometrium, Polyp Stromal 1 (2%) Endometrium, Sarcoma Stromal 1 (2%) Vagina (2) (2) Leiomyosarcoma 1 (50%) 1 (50%) ____________________________________________________________________________________________________________________________________ Page 3 NTP Experiment-Test: 88122-06 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC ELMIRON Date: 06/12/01 Route: GAVAGE Time: 09:18:08 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 MG/KG 28 MG/KG 84 MG/KG 252 MG/KG ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (50) (50) (50) (50) Lymph Node (7) (19) (14) (13) Lymph Node, Mandibular (3) (8) (3) (2) Lymph Node, Mesenteric (50) (50) (50) (49) Spleen (50) (50) (50) (50) Thymus (45) (41) (46) (41) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (50) (50) (50) (50) Adenolipoma 1 (2%) Adenoma 1 (2%) 1 (2%) Carcinoma 1 (2%) 1 (2%) 1 (2%) 3 (6%) Fibroadenoma 11 (22%) 21 (42%) 16 (32%) 17 (34%) Fibroadenoma, Multiple 4 (8%) 2 (4%) 8 (16%) 4 (8%) Skin (50) (50) (50) (50) Basal Cell Adenoma 1 (2%) Keratoacanthoma 1 (2%) Subcutaneous Tissue, Fibroma 1 (2%) 2 (4%) Subcutaneous Tissue, Fibrous Histiocytoma 1 (2%) Subcutaneous Tissue, Lipoma 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Skeletal Muscle (1) Leiomyosarcoma, Metastatic, Vagina 1 (100%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (50) (50) (50) Astrocytoma Malignant 1 (2%) Oligodendroglioma Malignant 1 (2%) ____________________________________________________________________________________________________________________________________ Page 4 NTP Experiment-Test: 88122-06 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC ELMIRON Date: 06/12/01 Route: GAVAGE Time: 09:18:08 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 MG/KG 28 MG/KG 84 MG/KG 252 MG/KG ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (50) (50) (50) Alveolar/Bronchiolar Carcinoma 1 (2%) Fibrous Histiocytoma 1 (2%) Leiomyosarcoma, Metastatic, Uterus 1 (2%) Pheochromocytoma Malignant, Metastatic, Adrenal Medulla 1 (2%) Nose (50) (50) (50) (50) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Zymbal's Gland (1) Adenoma 1 (100%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (50) (50) (50) ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS Multiple Organs *(50) *(50) *(50) *(50) Adenolipoma 1 (2%) Leukemia Mononuclear 7 (14%) 14 (28%) 8 (16%) 10 (20%) ____________________________________________________________________________________________________________________________________ * Number of animals with any tissue examined microscopically Page 5 NTP Experiment-Test: 88122-06 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC ELMIRON Date: 06/12/01 Route: GAVAGE Time: 09:18:08 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 MG/KG 28 MG/KG 84 MG/KG 252 MG/KG ____________________________________________________________________________________________________________________________________ TUMOR SUMMARY Total Animals with Primary Neoplasms (b) 42 45 44 40 Total Primary Neoplasms 79 80 90 82 Total Animals with Benign Neoplasms 37 41 41 35 Total Benign Neoplasms 66 63 74 65 Total Animals with Malignant Neoplasms 12 17 14 15 Total Malignant Neoplasms 13 17 16 17 Total Animals with Metastatic Neoplasms 2 1 Total Metastatic Neoplasm 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: 88122-06 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC ELMIRON Date: 06/12/01 Route: GAVAGE Time: 09:18:08 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 MG/KG 14 MG/KG 42 MG/KG 126 MG/KG ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially in Study 50 50 50 50 Early Deaths Natural Death 7 9 8 5 Moribund Sacrifice 15 10 17 12 Dosing Accident 2 2 5 Survivors Terminal Sacrifice 26 29 25 28 Animals Examined Microscopically 50 50 50 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Colon (50) (50) (50) (50) Intestine Large, Rectum (48) (48) (49) (45) Histiocytic Sarcoma 1 (2%) Polyp Adenomatous 1 (2%) 1 (2%) 1 (2%) Intestine Small, Duodenum (50) (50) (50) (50) Liver (50) (50) (50) (50) Histiocytic Sarcoma 1 (2%) Mesentery (9) (11) (9) (13) Schwannoma Malignant 1 (9%) Pancreas (50) (50) (50) (50) Acinus, Adenoma 1 (2%) Acinus, Carcinoma 1 (2%) Salivary Glands (50) (50) (49) (50) Schwannoma Malignant 1 (2%) 2 (4%) 1 (2%) 1 (2%) Stomach, Forestomach (50) (50) (50) (50) Stomach, Glandular (50) (50) (50) (50) Leiomyosarcoma 1 (2%) Tongue (1) Squamous Cell Papilloma 1 (100%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (50) (50) (50) (50) Histiocytic Sarcoma 1 (2%) ____________________________________________________________________________________________________________________________________ Page 7 NTP Experiment-Test: 88122-06 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC ELMIRON Date: 06/12/01 Route: GAVAGE Time: 09:18:08 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 MG/KG 14 MG/KG 42 MG/KG 126 MG/KG ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (50) (50) (50) (50) Adrenal Medulla (50) (50) (50) (50) Pheochromocytoma Malignant 1 (2%) 3 (6%) 1 (2%) Pheochromocytoma Benign 6 (12%) 6 (12%) 2 (4%) 8 (16%) Bilateral, Pheochromocytoma Benign 1 (2%) 1 (2%) 1 (2%) Islets, Pancreatic (50) (50) (50) (50) Adenoma 1 (2%) 1 (2%) 1 (2%) Carcinoma 1 (2%) Pituitary Gland (50) (50) (50) (50) Pars Distalis, Adenoma 19 (38%) 18 (36%) 18 (36%) 13 (26%) Pars Distalis, Carcinoma 1 (2%) Pars Intermedia, Adenoma 1 (2%) Thyroid Gland (50) (50) (50) (50) Schwannoma Malignant, Metastatic, Salivary Glands 1 (2%) Bilateral, C-Cell, Adenoma 1 (2%) 1 (2%) Bilateral, C-Cell, Carcinoma 1 (2%) Bilateral, Follicle, Carcinoma 1 (2%) C-Cell, Adenoma 5 (10%) 7 (14%) 8 (16%) 6 (12%) C-Cell, Adenoma, Multiple 2 (4%) 1 (2%) C-Cell, Carcinoma 1 (2%) 1 (2%) 1 (2%) Follicle, Adenoma 1 (2%) 1 (2%) 3 (6%) Follicle, Carcinoma 2 (4%) 1 (2%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Epididymis (50) (50) (50) (50) Preputial Gland (50) (50) (50) (50) Adenoma 1 (2%) 1 (2%) 1 (2%) 2 (4%) Carcinoma 1 (2%) Prostate (50) (50) (50) (49) Histiocytic Sarcoma 1 (2%) Seminal Vesicle (50) (50) (50) (49) Testes (50) (50) (50) (50) Bilateral, Interstitial Cell, Adenoma 35 (70%) 37 (74%) 37 (74%) 35 (70%) Interstitial Cell, Adenoma 9 (18%) 6 (12%) 6 (12%) 5 (10%) Page 8 NTP Experiment-Test: 88122-06 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC ELMIRON Date: 06/12/01 Route: GAVAGE Time: 09:18:08 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 MG/KG 14 MG/KG 42 MG/KG 126 MG/KG ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM - cont ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (50) (50) (50) (50) Lymph Node (11) (17) (10) (13) Deep Cervical, Carcinoma, Metastatic, Thyroid Gland 1 (9%) 1 (8%) Mediastinal, Carcinoma, Metastatic, Thyroid Gland 1 (9%) Lymph Node, Mandibular (5) (5) (9) (2) Lymph Node, Mesenteric (50) (50) (50) (49) Spleen (50) (50) (50) (50) Thymus (45) (44) (43) (43) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (49) (49) (50) (48) Adenoma 1 (2%) Fibroadenoma 2 (4%) 1 (2%) 3 (6%) 5 (10%) Fibroma 1 (2%) Skin (50) (50) (50) (50) Basal Cell Adenoma 1 (2%) Keratoacanthoma 2 (4%) 3 (6%) 3 (6%) 1 (2%) Squamous Cell Carcinoma 1 (2%) 1 (2%) Squamous Cell Papilloma 1 (2%) Sebaceous Gland, Adenoma 1 (2%) 1 (2%) 1 (2%) 2 (4%) Sebaceous Gland, Carcinoma 1 (2%) 1 (2%) Subcutaneous Tissue, Fibroma 1 (2%) 1 (2%) 3 (6%) 1 (2%) Subcutaneous Tissue, Fibrosarcoma 2 (4%) 2 (4%) 1 (2%) 1 (2%) Subcutaneous Tissue, Hemangiosarcoma 1 (2%) Subcutaneous Tissue, Lipoma 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (50) (50) (50) (50) Osteosarcoma 1 (2%) Vertebra, Chordoma 1 (2%) Skeletal Muscle (1) (2) Histiocytic Sarcoma 1 (100%) ____________________________________________________________________________________________________________________________________ Page 9 NTP Experiment-Test: 88122-06 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC ELMIRON Date: 06/12/01 Route: GAVAGE Time: 09:18:08 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 MG/KG 14 MG/KG 42 MG/KG 126 MG/KG ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (50) (50) (50) Astrocytoma Malignant 1 (2%) Carcinoma, Metastatic, Pituitary Gland 1 (2%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (50) (50) (50) Alveolar/Bronchiolar Adenoma 1 (2%) 1 (2%) 2 (4%) Alveolar/Bronchiolar Carcinoma 1 (2%) 1 (2%) Alveolar/Bronchiolar Carcinoma, Multiple 1 (2%) Carcinoma, Metastatic, Thyroid Gland 1 (2%) 1 (2%) 1 (2%) Chordoma, Metastatic, Bone 1 (2%) Histiocytic Sarcoma 1 (2%) Pheochromocytoma Malignant, Metastatic, Adrenal Medulla 1 (2%) Schwannoma Malignant, Metastatic, Salivary Glands 1 (2%) Nose (50) (50) (50) (50) Respiratory Epithelium, Adenoma 1 (2%) Trachea (50) (50) (50) (50) Schwannoma Malignant, Metastatic, Salivary Glands 1 (2%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM None ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (50) (50) (50) Ureter (1) Urinary Bladder (50) (50) (50) (49) Page 10 NTP Experiment-Test: 88122-06 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC ELMIRON Date: 06/12/01 Route: GAVAGE Time: 09:18:08 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 MG/KG 14 MG/KG 42 MG/KG 126 MG/KG ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS Multiple Organs *(50) *(50) *(50) *(50) Histiocytic Sarcoma 1 (2%) Leukemia Mononuclear 15 (30%) 16 (32%) 12 (24%) 16 (32%) Mesothelioma Malignant 2 (4%) 2 (4%) 4 (8%) ____________________________________________________________________________________________________________________________________ * Number of animals with any tissue examined microscopically Page 11 NTP Experiment-Test: 88122-06 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC ELMIRON Date: 06/12/01 Route: GAVAGE Time: 09:18:08 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 MG/KG 14 MG/KG 42 MG/KG 126 MG/KG ____________________________________________________________________________________________________________________________________ TUMOR SUMMARY Total Animals with Primary Neoplasms (b) 49 48 50 45 Total Primary Neoplasms 124 117 110 113 Total Animals with Benign Neoplasms 49 47 49 45 Total Benign Neoplasms 93 90 88 84 Total Animals with Malignant Neoplasms 29 25 22 25 Total Malignant Neoplasms 31 27 22 29 Total Animals with Metastatic Neoplasms 4 2 1 1 Total Metastatic Neoplasm 6 2 2 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 12 ------------------------------------------------------------ ---------- END OF REPORT ---------- ------------------------------------------------------------