TDMS Study 05085-01 Pathology Tables
INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) MANGANESE SULFATE NTP Experiment-Test: 05085-01 Report: PEIRPT05 Study Type: CHRONIC Date: 09/11/94 Route: DOSED FEED Time: 02:14:45 Facility: Battelle Columbus Laboratory Chemical CAS #: 7785-87-7 Lock Date: None 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: 05085-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC MANGANESE SULFATE Date: 09/11/94 Route: DOSED FEED Time: 02:14:45 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 PPM 1500 PPM 5000 PPM 15000 PPM ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially in Study 70 70 70 70 Scheduled Sacrifice 20 20 19 20 Early Deaths Natural Death 7 2 2 1 Moribund Sacrifice 6 11 6 11 Accidently Killed 1 Survivors Terminal Sacrifice 37 37 42 36 Wrong Sex 2 Animals Examined Microscopically 70 61 62 68 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Colon (70) (51) (50) (68) Adenocarcinoma 1 (1%) Liver (70) (54) (52) (68) Hepatocellular Carcinoma 1 (2%) Hepatocellular Adenoma 1 (2%) Mesentery (3) (4) (5) (2) Liposarcoma 1 (20%) Pancreas (70) (50) (50) (68) Salivary Glands (70) (51) (50) (68) Stomach, Forestomach (70) (51) (50) (68) Squamous Cell Papilloma 2 (4%) Stomach, Glandular (70) (51) (50) (68) Tongue (1) Squamous Cell Papilloma 1 (100%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (69) (51) (51) (68) Schwannoma Malignant, Metastatic, Lung 1 (2%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Gland, Cortex (70) (51) (51) (68) Adenoma 1 (1%) 1 (2%) Carcinoma 1 (1%) Adrenal Gland, Medulla (70) (51) (51) (68) Pheochromocytoma Complex 1 (1%) Page 2 NTP Experiment-Test: 05085-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC MANGANESE SULFATE Date: 09/11/94 Route: DOSED FEED Time: 02:14:45 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 PPM 1500 PPM 5000 PPM 15000 PPM ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM - cont Pheochromocytoma Benign 1 (1%) 4 (8%) 1 (1%) Islets, Pancreatic (70) (50) (50) (68) Adenoma 1 (2%) Parathyroid Gland (62) (47) (46) (65) Carcinoma, Metastatic, Thyroid Gland 1 (2%) Pituitary Gland (70) (51) (51) (67) Pars Distalis, Adenoma 22 (31%) 17 (33%) 19 (37%) 22 (33%) Pars Distalis, Adenoma, Multiple 1 (1%) Pars Distalis, Carcinoma 1 (2%) 2 (3%) Thyroid Gland (69) (51) (50) (67) Bilateral, C-Cell, Adenoma 2 (3%) C-Cell, Adenoma 8 (12%) 6 (12%) 6 (12%) 6 (9%) C-Cell, Adenoma, Multiple 1 (2%) C-Cell, Carcinoma 1 (1%) 2 (4%) 1 (2%) Follicular Cell, Adenoma 1 (1%) Follicular Cell, Carcinoma 1 (1%) 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Clitoral Gland (69) (51) (47) (63) Adenoma 5 (7%) 1 (2%) 6 (13%) 2 (3%) Carcinoma 1 (2%) 1 (2%) Ovary (70) (53) (51) (67) Granulosa Cell Tumor Malignant 1 (2%) Granulosa Cell Tumor Benign 1 (2%) 1 (1%) Granulosa-Theca Tumor Benign 1 (1%) Uterus (70) (51) (53) (67) Hemangiosarcoma 1 (1%) Leiomyoma 1 (1%) Polyp Stromal 13 (19%) 7 (14%) 8 (15%) 7 (10%) Sarcoma Stromal 1 (2%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Blood (41) (48) (48) (48) Bone Marrow (70) (51) (51) (68) Lymph Node (70) (51) (51) (68) Deep Cervical, Carcinoma, Metastatic, Thyroid Gland 1 (2%) Mediastinal, Rhabdomyosarcoma, Metastatic, Page 3 NTP Experiment-Test: 05085-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC MANGANESE SULFATE Date: 09/11/94 Route: DOSED FEED Time: 02:14:45 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 PPM 1500 PPM 5000 PPM 15000 PPM ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - cont Skeletal Muscle 1 (1%) Lymph Node, Mandibular (70) (51) (50) (67) Lymph Node, Mesenteric (69) (51) (51) (66) Spleen (70) (51) (51) (68) Hemangiosarcoma 1 (2%) Thymus (64) (49) (47) (65) Carcinoma, Metastatic 1 (2%) Thymoma Benign 2 (3%) 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (66) (50) (51) (65) Adenocarcinoma 1 (2%) Fibroadenoma 15 (23%) 14 (28%) 26 (51%) 11 (17%) Fibroadenoma, Multiple 4 (6%) 2 (4%) 5 (8%) Skin (70) (51) (51) (65) Basal Cell Adenoma 1 (1%) Basal Cell Carcinoma 1 (1%) Basosquamous Tumor Benign 1 (2%) Keratoacanthoma 1 (2%) Squamous Cell Papilloma 1 (2%) Subcutaneous Tissue, Fibroma 1 (2%) Subcutaneous Tissue, Fibrosarcoma 2 (4%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Skeletal Muscle (50) (50) (51) (48) Rhabdomyosarcoma 1 (2%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (70) (51) (51) (68) Carcinoma, Metastatic, Pituitary Gland 2 (3%) Granular Cell Tumor Benign 1 (1%) Oligodendroglioma NOS 1 (1%) Spinal Cord (1) Schwannoma NOS 1 (100%) ____________________________________________________________________________________________________________________________________ Page 4 NTP Experiment-Test: 05085-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC MANGANESE SULFATE Date: 09/11/94 Route: DOSED FEED Time: 02:14:45 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 PPM 1500 PPM 5000 PPM 15000 PPM ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (69) (51) (51) (68) Alveolar/Bronchiolar Adenoma 1 (1%) 1 (2%) 2 (3%) Fibrosarcoma, Metastatic, Skin 1 (2%) Mediastinum, Rhabdomyosarcoma, Metastatic, Skeletal Muscle 1 (1%) Mediastinum, Schwannoma Malignant 1 (2%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM None ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (70) (59) (61) (68) Liposarcoma, Metastatic, Mesentery 1 (2%) Renal Tubule, Adenoma 1 (2%) Renal Tubule, Carcinoma 1 (2%) Urinary Bladder (69) (51) (51) (68) Transitional Epithelium, Papilloma 1 (1%) ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS Multiple Organs *(70) *(61) *(62) *(68) Leukemia Mononuclear 19 (27%) 21 (34%) 26 (42%) 18 (26%) ____________________________________________________________________________________________________________________________________ * Number of animals with any tissue examined microscopically Page 5 NTP Experiment-Test: 05085-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC MANGANESE SULFATE Date: 09/11/94 Route: DOSED FEED Time: 02:14:45 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 PPM 1500 PPM 5000 PPM 15000 PPM ____________________________________________________________________________________________________________________________________ TUMOR SUMMARY Total Animals with Primary Neoplasms (b) 45 47 51 44 Total Primary Neoplasms 99 89 108 88 Total Animals with Benign Neoplasms 40 36 45 38 Total Benign Neoplasms 75 56 75 64 Total Animals with Malignant Neoplasms 24 26 30 22 Total Malignant Neoplasms 24 32 33 23 Total Animals with Metastatic Neoplasms 3 3 3 Total Metastatic Neoplasm 3 3 4 Total Animals with Malignant Neoplasms Uncertain Primary Site Total Animals with Neoplasms Uncertain- Benign or Malignant 1 1 Total Uncertain Neoplasms 1 1 ____________________________________________________________________________________________________________________________________ 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: 05085-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC MANGANESE SULFATE Date: 09/11/94 Route: DOSED FEED Time: 02:14:45 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 PPM 1500 PPM 5000 PPM 15000 PPM ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially in Study 70 70 70 70 Scheduled Sacrifice 18 19 19 18 Early Deaths Natural Death 6 10 5 7 Moribund Sacrifice 21 24 24 38 Survivors Natural Death 1 Terminal Sacrifice 25 17 21 7 Animals Examined Microscopically 70 70 70 70 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Cecum (70) (51) (50) (69) Intestine Large, Colon (70) (52) (50) (70) Intestine Large, Rectum (70) (52) (51) (70) Histiocytic Sarcoma 1 (1%) Polyp Adenomatous 1 (1%) Intestine Small, Duodenum (70) (52) (51) (70) Intestine Small, Ileum (70) (51) (51) (69) Intestine Small, Jejunum (70) (52) (51) (69) Polyp Adenomatous 1 (2%) Liver (70) (53) (52) (70) Hepatocellular Adenoma 1 (2%) Hepatocellular Adenoma, Multiple 1 (2%) Histiocytic Sarcoma 1 (1%) Mesentery (8) (9) (5) (6) Pancreas (70) (51) (51) (69) Acinus, Adenoma 2 (4%) 1 (2%) Pharynx (1) Squamous Cell Papilloma 1 (100%) Salivary Glands (70) (48) (51) (69) Stomach, Forestomach (70) (54) (52) (70) Squamous Cell Papilloma 1 (2%) Squamous Cell Papilloma, Multiple 1 (1%) Stomach, Glandular (70) (52) (52) (70) Tongue (1) Squamous Cell Papilloma 1 (100%) Tooth (61) (50) (51) (59) Gingiva, Squamous Cell Carcinoma 1 (2%) ____________________________________________________________________________________________________________________________________ Page 7 NTP Experiment-Test: 05085-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC MANGANESE SULFATE Date: 09/11/94 Route: DOSED FEED Time: 02:14:45 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 PPM 1500 PPM 5000 PPM 15000 PPM ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (70) (52) (51) (70) Alveolar/Bronchiolar Carcinoma, Metastatic, Lung 1 (1%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Gland, Cortex (70) (52) (51) (70) Adenoma 1 (1%) 1 (1%) Adrenal Gland, Medulla (70) (52) (51) (70) Pheochromocytoma Malignant 1 (1%) 1 (2%) Pheochromocytoma Complex 1 (2%) 1 (2%) Pheochromocytoma Benign 9 (13%) 12 (23%) 12 (24%) 4 (6%) Bilateral, Pheochromocytoma Benign 5 (7%) 5 (10%) 2 (4%) 2 (3%) Islets, Pancreatic (70) (51) (51) (69) Adenoma 3 (6%) 4 (8%) 3 (4%) Carcinoma 1 (1%) Mixed Tumor Benign 1 (2%) Parathyroid Gland (68) (47) (49) (66) Adenoma 1 (1%) Pituitary Gland (69) (50) (51) (68) Ependymoma Malignant, Metastatic, Brain 1 (1%) Pars Distalis, Adenoma 13 (19%) 12 (24%) 14 (27%) 14 (21%) Pars Distalis, Adenoma, Multiple 1 (2%) 1 (1%) Pars Distalis, Carcinoma 1 (2%) Pars Intermedia, Adenoma 1 (2%) Pars Intermedia, Carcinoma 1 (2%) Thyroid Gland (70) (49) (51) (69) Bilateral, C-Cell, Adenoma 1 (2%) C-Cell, Adenoma 6 (9%) 6 (12%) 7 (14%) 4 (6%) C-Cell, Adenoma, Multiple 1 (2%) C-Cell, Carcinoma 1 (1%) Follicular Cell, Adenoma 1 (1%) 1 (2%) 1 (2%) 3 (4%) Follicular Cell, Carcinoma 2 (4%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ Page 8 NTP Experiment-Test: 05085-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC MANGANESE SULFATE Date: 09/11/94 Route: DOSED FEED Time: 02:14:45 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 PPM 1500 PPM 5000 PPM 15000 PPM ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Epididymis (70) (52) (51) (70) Preputial Gland (70) (53) (52) (70) Adenoma 3 (4%) 2 (4%) 2 (4%) Carcinoma 2 (3%) 2 (4%) 1 (2%) 2 (3%) Bilateral, Carcinoma 3 (6%) Prostate (70) (52) (51) (69) Seminal Vesicle (70) (52) (51) (70) Testes (70) (54) (51) (70) Bilateral, Interstitial Cell, Adenoma 36 (51%) 31 (57%) 33 (65%) 31 (44%) Interstitial Cell, Adenoma 12 (17%) 13 (24%) 9 (18%) 12 (17%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Blood (46) (42) (44) (41) Bone Marrow (70) (52) (51) (70) Femoral, Fibrosarcoma 1 (1%) Lymph Node (70) (52) (51) (70) Renal, Carcinoma, Metastatic, Kidney 1 (1%) Lymph Node, Mandibular (69) (48) (51) (68) Fibrosarcoma, Metastatic, Skin 1 (2%) Lymph Node, Mesenteric (68) (51) (51) (69) Spleen (70) (52) (51) (70) Fibrosarcoma 1 (2%) Hemangioma 1 (1%) Thymus (66) (48) (49) (62) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (58) (39) (36) (53) Fibroadenoma 1 (2%) 1 (3%) 2 (4%) Skin (65) (52) (50) (70) Basal Cell Adenoma 2 (4%) Basal Cell Carcinoma 1 (2%) 1 (2%) Basosquamous Tumor Benign 1 (2%) Keratoacanthoma 1 (2%) 1 (2%) Keratoacanthoma, Multiple 1 (1%) Squamous Cell Carcinoma 1 (2%) 1 (2%) Squamous Cell Papilloma 1 (2%) 1 (1%) Trichoepithelioma 1 (2%) Subcutaneous Tissue, Fibroma 1 (1%) Subcutaneous Tissue, Fibrosarcoma 1 (2%) 1 (2%) Subcutaneous Tissue, Fibrous Histiocytoma 2 (3%) Subcutaneous Tissue, Lipoma 1 (2%) Subcutaneous Tissue, Neurofibroma 1 (2%) Page 9 NTP Experiment-Test: 05085-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC MANGANESE SULFATE Date: 09/11/94 Route: DOSED FEED Time: 02:14:45 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 PPM 1500 PPM 5000 PPM 15000 PPM ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM - cont Subcutaneous Tissue, Neurofibrosarcoma 2 (3%) 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (70) (52) (51) (70) Alveolar/Bronchiolar Carcinoma, Metastatic, Lung 1 (1%) Squamous Cell Carcinoma, Metastatic, Tooth 1 (2%) Femur, Fibrosarcoma 1 (1%) Skeletal Muscle (52) (51) (51) (52) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (70) (51) (51) (70) Astrocytoma Malignant 2 (3%) Carcinoma, Metastatic, Pituitary Gland 1 (2%) 1 (2%) Ependymoma Malignant 1 (1%) Granular Cell Tumor Benign 1 (1%) Spinal Cord (1) (2) (1) Glioma Benign 1 (100%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (70) (52) (51) (70) Alveolar/Bronchiolar Adenoma 1 (1%) 3 (6%) Alveolar/Bronchiolar Carcinoma 2 (3%) 1 (1%) Fibrous Histiocytoma, Metastatic, Skin 1 (1%) Histiocytic Sarcoma 1 (1%) Neurofibrosarcoma, Metastatic, Uncertain Primary Site 1 (1%) Pheochromocytoma Malignant, Metastatic, Adrenal Gland 1 (1%) Nose (70) (51) (51) (70) Squamous Cell Papilloma 1 (2%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Ear (1) (1) Fibrosarcoma 1 (100%) Squamous Cell Papilloma, Multiple 1 (100%) Zymbal's Gland (2) (1) (1) Adenoma 1 (100%) Carcinoma 2 (100%) 1 (100%) Page 10 NTP Experiment-Test: 05085-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC MANGANESE SULFATE Date: 09/11/94 Route: DOSED FEED Time: 02:14:45 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 PPM 1500 PPM 5000 PPM 15000 PPM ____________________________________________________________________________________________________________________________________ ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (70) (69) (70) (70) Lipoma 1 (1%) Renal Tubule, Adenoma 1 (1%) 2 (3%) 1 (1%) Renal Tubule, Oncocytoma Benign 1 (1%) 1 (1%) Urinary Bladder (70) (51) (51) (70) Transitional Epithelium, Papilloma 1 (1%) ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS Multiple Organs *(70) *(70) *(70) *(70) Histiocytic Sarcoma 1 (1%) Leukemia Mononuclear 32 (46%) 31 (44%) 30 (43%) 25 (36%) Mesothelioma Malignant 2 (3%) 2 (3%) 1 (1%) ____________________________________________________________________________________________________________________________________ * Number of animals with any tissue examined microscopically Page 11 NTP Experiment-Test: 05085-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC MANGANESE SULFATE Date: 09/11/94 Route: DOSED FEED Time: 02:14:45 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 PPM 1500 PPM 5000 PPM 15000 PPM ____________________________________________________________________________________________________________________________________ TUMOR SUMMARY Total Animals with Primary Neoplasms (b) 54 50 50 54 Total Primary Neoplasms 148 143 141 118 Total Animals with Benign Neoplasms 53 48 49 49 Total Benign Neoplasms 97 100 101 83 Total Animals with Malignant Neoplasms 38 38 34 31 Total Malignant Neoplasms 51 43 40 35 Total Animals with Metastatic Neoplasms 2 2 2 4 Total Metastatic Neoplasm 2 2 2 5 Total Animals with Malignant Neoplasms 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 12 ------------------------------------------------------------ ---------- END OF REPORT ---------- ------------------------------------------------------------