TDMS Study 88007-06 Pathology Tables
NTP Experiment-Test: 88007-06 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC SODIUM NITRITE Date: 05/13/99 Route: DOSED WATER Time: 09:40:38 2 YEAR CHRONIC MICE Facility: Battelle Columbus Laboratory Chemical CAS #: 7632-00-0 Lock Date: 03/20/98 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: 88007-06 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC SODIUM NITRITE Date: 05/13/99 Route: DOSED WATER Time: 09:40:38 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0.0% 0.075% 0.15% 0.30% ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially in Study 50 50 50 50 Early Deaths Moribund Sacrifice 1 7 2 4 Natural Death 9 9 11 5 Survivors Terminal Sacrifice 40 34 37 41 Animals Examined Microscopically 50 50 50 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Gallbladder (48) (50) (50) (49) Intestine Large, Rectum (49) (50) (50) (50) Fibrosarcoma, Metastatic, Skin 1 (2%) Intestine Small, Jejunum (50) (50) (50) (50) Intestine Small, Ileum (49) (49) (50) (50) Leiomyosarcoma, Metastatic, Uterus 1 (2%) Liver (50) (50) (50) (50) Carcinoma, Metastatic, Islets, Pancreatic 1 (2%) Fibrosarcoma, Metastatic, Skin 1 (2%) Hemangiosarcoma 1 (2%) Hepatocellular Carcinoma 2 (4%) 2 (4%) 4 (8%) 1 (2%) Hepatocellular Adenoma 9 (18%) 6 (12%) 2 (4%) 5 (10%) Hepatocellular Adenoma, Multiple 1 (2%) 1 (2%) 1 (2%) Hepatocholangiocarcinoma 1 (2%) 1 (2%) Mesentery (14) (19) (17) (13) Carcinoma, Metastatic, Islets, Pancreatic 1 (5%) Fibrosarcoma, Metastatic, Skin 1 (5%) 1 (6%) Hepatocholangiocarcinoma, Metastatic, Liver 1 (7%) 1 (5%) Osteosarcoma, Metastatic, Bone 1 (6%) Sarcoma 1 (6%) Pancreas (50) (50) (50) (50) Hepatocholangiocarcinoma, Metastatic, Liver 1 (2%) 1 (2%) Salivary Glands (49) (49) (48) (50) Schwannoma Malignant, Metastatic, Skin 1 (2%) Stomach, Forestomach (50) (50) (50) (50) Squamous Cell Carcinoma 2 (4%) Squamous Cell Papilloma 1 (2%) 1 (2%) 3 (6%) Stomach, Glandular (50) (50) (50) (50) Hepatocholangiocarcinoma, Metastatic, Liver 1 (2%) ____________________________________________________________________________________________________________________________________ NTP Experiment-Test: 88007-06 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC SODIUM NITRITE Date: 05/13/99 Route: DOSED WATER Time: 09:40:38 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0.0% 0.075% 0.15% 0.30% ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (50) (50) (50) (50) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (50) (50) (49) (50) Fibrosarcoma, Metastatic, Skin 1 (2%) Hepatocholangiocarcinoma, Metastatic, Liver 1 (2%) Osteosarcoma, Metastatic, Bone 1 (2%) Adrenal Medulla (50) (50) (48) (49) Pheochromocytoma Benign 1 (2%) 1 (2%) Islets, Pancreatic (50) (50) (50) (50) Adenoma 3 (6%) Carcinoma 1 (2%) Pituitary Gland (48) (47) (43) (48) Pars Distalis, Adenoma 1 (2%) 3 (6%) 1 (2%) Thyroid Gland (49) (49) (48) (49) Bilateral, Follicular Cell, Adenoma 1 (2%) Follicular Cell, Carcinoma 1 (2%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM Peritoneum (1) (1) Hepatocholangiocarcinoma, Metastatic, Liver 1 (100%) ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Clitoral Gland (50) (49) (50) (48) Ovary (47) (49) (50) (49) Cystadenoma 2 (4%) 1 (2%) 3 (6%) Granulosa Cell Tumor Benign 1 (2%) Hemangioma 2 (4%) 1 (2%) 1 (2%) Hepatocholangiocarcinoma, Metastatic, Liver 1 (2%) Luteoma 1 (2%) Osteosarcoma, Metastatic, Bone 1 (2%) Teratoma Benign 1 (2%) Uterus (50) (50) (50) (50) Leiomyosarcoma 1 (2%) Polyp Stromal 3 (6%) 1 (2%) ____________________________________________________________________________________________________________________________________ NTP Experiment-Test: 88007-06 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC SODIUM NITRITE Date: 05/13/99 Route: DOSED WATER Time: 09:40:38 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0.0% 0.075% 0.15% 0.30% ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (50) (50) (50) (50) Hemangiosarcoma 1 (2%) Lymph Node (7) (7) (8) (4) Mediastinal, Hepatocholangiocarcinoma, Metastatic, Liver 1 (14%) 1 (14%) Mediastinal, Sarcoma, Metastatic, Skin 1 (14%) Lymph Node, Mandibular (47) (46) (48) (48) Lymph Node, Mesenteric (50) (49) (47) (49) Spleen (49) (50) (50) (50) Hemangiosarcoma 1 (2%) 2 (4%) Thymus (46) (47) (44) (46) Hepatocholangiocarcinoma, Metastatic, Liver 1 (2%) Thymoma Benign 1 (2%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Skin (50) (50) (50) (50) Subcutaneous Tissue, Fibrosarcoma 5 (10%) 1 (2%) 2 (4%) Subcutaneous Tissue, Hemangiosarcoma 1 (2%) Subcutaneous Tissue, Sarcoma 1 (2%) Subcutaneous Tissue, Schwannoma Malignant 2 (4%) Subcutaneous Tissue, Pinna, Fibroma 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (50) (50) (50) (50) Femur, Osteosarcoma 1 (2%) Vertebra, Osteosarcoma 1 (2%) Skeletal Muscle (3) (2) (1) (3) Carcinoma, Metastatic, Islets, Pancreatic 1 (50%) Hepatocholangiocarcinoma, Metastatic, Liver 1 (33%) Osteosarcoma, Metastatic, Bone 1 (100%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (50) (49) (50) Spinal Cord (2) Meninges, Meningioma Malignant 1 (50%) ____________________________________________________________________________________________________________________________________ NTP Experiment-Test: 88007-06 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC SODIUM NITRITE Date: 05/13/99 Route: DOSED WATER Time: 09:40:38 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0.0% 0.075% 0.15% 0.30% ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (50) (50) (50) Alveolar/Bronchiolar Adenoma 1 (2%) 4 (8%) 2 (4%) 5 (10%) Alveolar/Bronchiolar Adenoma, Multiple 1 (2%) Alveolar/Bronchiolar Carcinoma 3 (6%) 2 (4%) 1 (2%) Carcinoma, Metastatic, Uncertain Primary Site 1 (2%) Fibrosarcoma, Metastatic, Skin 2 (4%) 1 (2%) Hepatocellular Carcinoma, Metastatic, Liver 1 (2%) 1 (2%) 1 (2%) Hepatocholangiocarcinoma, Metastatic, Liver 1 (2%) 1 (2%) Osteosarcoma, Metastatic, Bone 1 (2%) 1 (2%) Sarcoma, Metastatic, Skin 1 (2%) Schwannoma Malignant, Metastatic, Skin 1 (2%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Harderian Gland (1) (1) (2) Adenoma 1 (100%) 2 (100%) Carcinoma 1 (100%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (50) (50) (50) Fibrosarcoma, Metastatic, Skin 1 (2%) Hepatocholangiocarcinoma, Metastatic, Liver 1 (2%) Urinary Bladder (50) (50) (50) (50) Hepatocholangiocarcinoma, Metastatic, Liver 1 (2%) ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS Multiple Organs *(50) *(50) *(50) *(50) Lymphoma Malignant 7 (14%) 10 (20%) 8 (16%) 6 (12%) ____________________________________________________________________________________________________________________________________ * Number of animals with any tissue examined microscopically Page 5 NTP Experiment-Test: 88007-06 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC SODIUM NITRITE Date: 05/13/99 Route: DOSED WATER Time: 09:40:38 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0.0% 0.075% 0.15% 0.30% ____________________________________________________________________________________________________________________________________ TUMOR SUMMARY Total Animals with Primary Neoplasms (b) 21 32 31 32 Total Primary Neoplasms 25 49 36 41 Total Animals with Benign Neoplasms 13 22 14 20 Total Benign Neoplasms 13 25 14 24 Total Animals with Malignant Neoplasms 12 20 19 17 Total Malignant Neoplasms 12 24 22 17 Total Animals with Metastatic Neoplasms 3 6 4 3 Total Metastatic Neoplasm 11 15 13 4 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 NTP Experiment-Test: 88007-06 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC SODIUM NITRITE Date: 05/13/99 Route: DOSED WATER Time: 09:40:38 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0.0% 0.075% 0.15% 0.30% ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially in Study 50 50 50 50 Early Deaths Moribund Sacrifice 3 2 3 1 Natural Death 8 3 5 10 Survivors Terminal Sacrifice 39 45 42 39 Animals Examined Microscopically 50 50 50 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Small, Duodenum (49) (50) (48) (49) Carcinoma 1 (2%) Carcinoma, Metastatic, Intestine Small, Jejunum 1 (2%) Polyp Adenomatous 2 (4%) 4 (8%) 3 (6%) Intestine Small, Jejunum (50) (50) (50) (50) Carcinoma 5 (10%) 1 (2%) 1 (2%) Leiomyosarcoma 1 (2%) Polyp Adenomatous 1 (2%) Liver (50) (50) (50) (50) Alveolar/Bronchiolar Carcinoma, Metastatic, Lung 1 (2%) Carcinoma, Metastatic, Islets, Pancreatic 1 (2%) Cholangiocarcinoma 1 (2%) Hemangiosarcoma 2 (4%) 2 (4%) 1 (2%) 2 (4%) Hemangiosarcoma, Metastatic, Spleen 2 (4%) Hepatoblastoma 5 (10%) 1 (2%) 2 (4%) Hepatocellular Carcinoma 9 (18%) 10 (20%) 6 (12%) 6 (12%) Hepatocellular Carcinoma, Multiple 3 (6%) Hepatocellular Adenoma 10 (20%) 15 (30%) 8 (16%) 13 (26%) Hepatocellular Adenoma, Multiple 9 (18%) 2 (4%) 5 (10%) 5 (10%) Sarcoma 1 (2%) Mesentery (7) (6) (7) (5) Alveolar/Bronchiolar Carcinoma, Metastatic, Lung 1 (20%) Cholangiocarcinoma, Metastatic, Liver 1 (20%) Hepatoblastoma, Metastatic, Liver 1 (14%) Sarcoma, Metastatic, Liver 1 (14%) Pancreas (49) (50) (50) (50) Alveolar/Bronchiolar Carcinoma, Metastatic, Lung 1 (2%) Cholangiocarcinoma, Metastatic, Liver 1 (2%) Hepatoblastoma, Metastatic, Liver 1 (2%) NTP Experiment-Test: 88007-06 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC SODIUM NITRITE Date: 05/13/99 Route: DOSED WATER Time: 09:40:38 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0.0% 0.075% 0.15% 0.30% ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - cont Salivary Glands (50) (50) (50) (50) Stomach, Forestomach (50) (50) (50) (50) Squamous Cell Papilloma 1 (2%) 1 (2%) 1 (2%) Stomach, Glandular (50) (50) (50) (50) Sarcoma, Metastatic, Liver 1 (2%) Tooth (5) (5) (4) (1) Odontoma 2 (40%) 1 (25%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (50) (50) (50) (50) Alveolar/Bronchiolar Carcinoma, Metastatic, Lung 1 (2%) Fibrosarcoma, Metastatic, Uncertain Primary Site 1 (2%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (50) (50) (50) (50) Cholangiocarcinoma, Metastatic, Liver 1 (2%) Islets, Pancreatic (50) (50) (50) (50) Adenoma 3 (6%) 2 (4%) 2 (4%) Carcinoma 1 (2%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Epididymis (50) (50) (50) (50) Prostate (50) (50) (49) (50) Cholangiocarcinoma, Metastatic, Liver 1 (2%) Seminal Vesicle (50) (50) (50) (50) Cholangiocarcinoma, Metastatic, Liver 1 (2%) Testes (50) (50) (50) (50) Hemangiosarcoma, Metastatic, Liver 1 (2%) Interstitial Cell, Adenoma 2 (4%) ____________________________________________________________________________________________________________________________________ NTP Experiment-Test: 88007-06 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC SODIUM NITRITE Date: 05/13/99 Route: DOSED WATER Time: 09:40:38 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0.0% 0.075% 0.15% 0.30% ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (50) (50) (49) (50) Hemangiosarcoma 2 (4%) Lymph Node (1) (1) (3) (5) Mediastinal, Alveolar/Bronchiolar Carcinoma, Metastatic, Lung 1 (20%) Pancreatic, Cholangiocarcinoma, Metastatic, Liver 1 (20%) Renal, Cholangiocarcinoma, Metastatic, Liver 1 (20%) Lymph Node, Mandibular (47) (50) (47) (48) Carcinoma, Metastatic, Harderian Gland 1 (2%) Lymph Node, Mesenteric (49) (49) (48) (49) Hemangiosarcoma, Metastatic, Liver 1 (2%) Spleen (50) (50) (50) (50) Hemangiosarcoma 3 (6%) 2 (4%) Hemangiosarcoma, Metastatic, Bone Marrow 1 (2%) Hemangiosarcoma, Metastatic, Liver 1 (2%) 1 (2%) Hemangiosarcoma, Metastatic, Skin 1 (2%) Thymus (37) (39) (38) (42) Alveolar/Bronchiolar Carcinoma, Metastatic, Lung 1 (2%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Skin (50) (50) (50) (50) Subcutaneous Tissue, Hemangiosarcoma 1 (2%) Subcutaneous Tissue, Sarcoma, Metastatic, Brain 1 (2%) Subcutaneous Tissue, Pinna, Melanoma Malignant 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM None ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (50) (50) (50) Sarcoma 1 (2%) ____________________________________________________________________________________________________________________________________ NTP Experiment-Test: 88007-06 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC SODIUM NITRITE Date: 05/13/99 Route: DOSED WATER Time: 09:40:38 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0.0% 0.075% 0.15% 0.30% ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (50) (50) (50) Alveolar/Bronchiolar Adenoma 10 (20%) 5 (10%) 8 (16%) 10 (20%) Alveolar/Bronchiolar Adenoma, Multiple 1 (2%) Alveolar/Bronchiolar Carcinoma 4 (8%) 1 (2%) 3 (6%) 7 (14%) Alveolar/Bronchiolar Carcinoma, Metastatic, Lung 1 (2%) 1 (2%) Carcinoma, Metastatic, Harderian Gland 1 (2%) Carcinoma, Metastatic, Intestine Small, Jejunum 1 (2%) Cholangiocarcinoma, Metastatic, Liver 1 (2%) Fibrosarcoma, Metastatic, Uncertain Primary Site 1 (2%) Hemangiosarcoma, Metastatic, Liver 1 (2%) Hepatoblastoma, Metastatic, Liver 2 (4%) Hepatocellular Carcinoma, Metastatic, Liver 3 (6%) 2 (4%) 2 (4%) 2 (4%) Hepatocholangiocarcinoma, Metastatic, Liver 1 (2%) Sarcoma, Metastatic, Brain 1 (2%) Sarcoma, Metastatic, Liver 1 (2%) Mediastinum, Alveolar/Bronchiolar Carcinoma, Metastatic, Lung 1 (2%) 2 (4%) Mediastinum, Fibrosarcoma, Metastatic, Uncertain Primary Site 1 (2%) Mediastinum, Hemangiosarcoma, Metastatic, Bone Marrow 1 (2%) Mediastinum, Sarcoma, Metastatic, Brain 1 (2%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Harderian Gland (5) (4) (6) (1) Adenoma 4 (80%) 3 (75%) 4 (67%) 1 (100%) Carcinoma 2 (33%) Sarcoma, Metastatic, Brain 1 (20%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (50) (50) (50) Alveolar/Bronchiolar Carcinoma, Metastatic, Lung 2 (4%) Renal Tubule, Adenoma 1 (2%) NTP Experiment-Test: 88007-06 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC SODIUM NITRITE Date: 05/13/99 Route: DOSED WATER Time: 09:40:38 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0.0% 0.075% 0.15% 0.30% ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS Multiple Organs *(50) *(50) *(50) *(50) Lymphoma Malignant 1 (2%) 1 (2%) 4 (8%) 1 (2%) ____________________________________________________________________________________________________________________________________ * Number of animals with any tissue examined microscopically Page 11 NTP Experiment-Test: 88007-06 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC SODIUM NITRITE Date: 05/13/99 Route: DOSED WATER Time: 09:40:38 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0.0% 0.075% 0.15% 0.30% ____________________________________________________________________________________________________________________________________ TUMOR SUMMARY Total Animals with Primary Neoplasms (b) 40 35 36 38 Total Primary Neoplasms 72 55 55 52 Total Animals with Benign Neoplasms 28 28 26 29 Total Benign Neoplasms 39 37 32 31 Total Animals with Malignant Neoplasms 27 15 20 20 Total Malignant Neoplasms 33 18 23 21 Total Animals with Metastatic Neoplasms 13 4 7 7 Total Metastatic Neoplasm 18 7 11 24 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 ------------------------------------------------------------ ---------- END OF REPORT ---------- ------------------------------------------------------------