TDMS Study 88007-05 Pathology Tables
NTP Experiment-Test: 88007-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC SODIUM NITRITE Date: 10/18/99
Route: DOSED WATER Time: 13:52:35
FINAL #1 CORE STUDY RATS
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: 88007-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC SODIUM NITRITE Date: 10/18/99
Route: DOSED WATER Time: 13:52:35
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0.0% 0.075% 0.15% 0.30%
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially in Study 50 50 50 50
Early Deaths
Moribund Sacrifice 11 6 10 15
Natural Death 6 13 4 2
Survivors
Terminal Sacrifice 33 31 36 33
Animals Examined Microscopically 50 50 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Intestine Large, Rectum (50) (50) (50) (50)
Fibroma 1 (2%)
Intestine Small, Jejunum (50) (44) (49) (50)
Leiomyoma 1 (2%)
Liver (50) (50) (50) (50)
Oral Mucosa (1) (1)
Squamous Cell Carcinoma 1 (100%) 1 (100%)
Stomach, Forestomach (50) (50) (50) (50)
Squamous Cell Papilloma 1 (2%)
Tongue (2) (1)
Squamous Cell Carcinoma 1 (50%) 1 (100%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Blood Vessel (50) (50) (50) (50)
Heart (50) (49) (50) (50)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (50) (50) (50) (50)
Adenoma 1 (2%) 1 (2%) 1 (2%) 1 (2%)
Carcinoma 1 (2%) 1 (2%)
Adrenal Medulla (50) (50) (45) (49)
Pheochromocytoma Benign 4 (8%) 2 (4%) 2 (4%)
Pituitary Gland (50) (50) (50) (50)
Pars Distalis, Adenoma 24 (48%) 25 (50%) 17 (34%) 21 (42%)
Thyroid Gland (50) (49) (48) (50)
Bilateral, C-Cell, Adenoma 1 (2%)
C-Cell, Adenoma 7 (14%) 4 (8%) 10 (21%) 6 (12%)
C-Cell, Carcinoma 2 (4%) 1 (2%)
Follicular Cell, Adenoma 1 (2%)
NTP Experiment-Test: 88007-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC SODIUM NITRITE Date: 10/18/99
Route: DOSED WATER Time: 13:52:35
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0.0% 0.075% 0.15% 0.30%
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM - cont
Follicular Cell, Carcinoma 1 (2%) 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Clitoral Gland (46) (48) (49) (49)
Adenoma 8 (17%) 8 (17%) 5 (10%) 3 (6%)
Carcinoma 2 (4%) 1 (2%) 1 (2%)
Bilateral, Adenoma 2 (4%) 1 (2%)
Ovary (50) (49) (50) (50)
Granulosa Cell Tumor Benign 1 (2%)
Schwannoma Malignant 1 (2%)
Sertoli Cell Tumor Malignant 1 (2%)
Uterus (50) (50) (50) (50)
Adenocarcinoma 2 (4%)
Adenoma 1 (2%)
Polyp Stromal 7 (14%) 3 (6%) 8 (16%) 7 (14%)
Sarcoma Stromal 1 (2%)
Cervix, Carcinoma 1 (2%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (50) (50) (50) (50)
Lymph Node (2) (1) (2) (1)
Carcinoma, Metastatic, Lung 1 (50%)
Mediastinal, Carcinoma, Metastatic, Adrenal
Cortex 1 (100%)
Lymph Node, Mandibular (49) (49) (50) (50)
Carcinoma, Metastatic, Zymbal's Gland 1 (2%)
Lymph Node, Mesenteric (50) (50) (50) (50)
Spleen (50) (50) (50) (50)
Thymus (49) (47) (49) (48)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (50) (50) (50) (50)
Adenoma 1 (2%) 1 (2%) 3 (6%)
Adenoma, Multiple 1 (2%)
Carcinoma 1 (2%) 1 (2%) 2 (4%) 2 (4%)
Fibroadenoma 14 (28%) 14 (28%) 18 (36%) 20 (40%)
NTP Experiment-Test: 88007-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC SODIUM NITRITE Date: 10/18/99
Route: DOSED WATER Time: 13:52:35
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0.0% 0.075% 0.15% 0.30%
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM - cont
Fibroadenoma, Multiple 7 (14%) 13 (26%) 13 (26%) 5 (10%)
Skin (50) (50) (50) (50)
Basal Cell Adenoma 1 (2%)
Basal Cell Carcinoma 1 (2%) 1 (2%)
Fibroma 1 (2%) 1 (2%) 1 (2%)
Fibrosarcoma 1 (2%)
Hemangiopericytoma 1 (2%)
Lipoma 2 (4%)
Squamous Cell Carcinoma 1 (2%) 1 (2%)
Trichoepithelioma 1 (2%)
Pinna, Melanoma Malignant 1 (2%) 1 (2%)
Subcutaneous Tissue, Fibroma 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
None
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (50) (50) (50)
Astrocytoma Malignant 1 (2%)
Spinal Cord (1)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (50) (50) (50)
Alveolar/Bronchiolar Adenoma 3 (6%) 2 (4%) 3 (6%) 2 (4%)
Alveolar/Bronchiolar Carcinoma 1 (2%)
Carcinoma, Metastatic, Adrenal Cortex 1 (2%)
Sarcoma 1 (2%)
Nose (50) (49) (50) (50)
Squamous Cell Carcinoma, Metastatic, Skin 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Zymbal's Gland (2) (2)
Carcinoma 1 (50%) 1 (50%)
____________________________________________________________________________________________________________________________________
NTP Experiment-Test: 88007-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC SODIUM NITRITE Date: 10/18/99
Route: DOSED WATER Time: 13:52:35
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0.0% 0.075% 0.15% 0.30%
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (50) (50) (50)
Nephroblastoma 1 (2%)
Renal Tubule, Adenoma 1 (2%)
Urinary Bladder (50) (50) (50) (50)
____________________________________________________________________________________________________________________________________
SYSTEMIC LESIONS
Multiple Organs *(50) *(50) *(50) *(50)
Leukemia Mononuclear 15 (30%) 10 (20%) 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
* Number of animals with any tissue examined microscopically
Page 5
NTP Experiment-Test: 88007-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC SODIUM NITRITE Date: 10/18/99
Route: DOSED WATER Time: 13:52:35
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0.0% 0.075% 0.15% 0.30%
____________________________________________________________________________________________________________________________________
TUMOR SUMMARY
Total Animals with Primary Neoplasms (b) 45 45 49 45
Total Primary Neoplasms 107 94 95 87
Total Animals with Benign Neoplasms 42 42 46 42
Total Benign Neoplasms 81 77 82 75
Total Animals with Malignant Neoplasms 23 16 12 12
Total Malignant Neoplasms 26 17 13 12
Total Animals with Metastatic Neoplasms 1 1 2
Total Metastatic Neoplasm 2 1 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
NTP Experiment-Test: 88007-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC SODIUM NITRITE Date: 10/18/99
Route: DOSED WATER Time: 13:52:35
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0.0% 0.075% 0.15% 0.30%
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially in Study 50 50 50 50
Early Deaths
Moribund Sacrifice 16 4 12 8
Natural Death 5 8 2 6
Survivors
Terminal Sacrifice 29 37 36 36
Natural Death 1
Animals Examined Microscopically 50 50 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Esophagus (50) (50) (50) (50)
Intestine Large, Colon (50) (50) (50) (50)
Carcinoma 1 (2%)
Leiomyosarcoma 1 (2%)
Schwannoma Malignant, Metastatic, Heart 1 (2%)
Intestine Large, Cecum (50) (50) (50) (49)
Intestine Small, Duodenum (49) (50) (50) (50)
Intestine Small, Jejunum (50) (48) (50) (49)
Intestine Small, Ileum (50) (49) (50) (49)
Liver (50) (50) (50) (50)
Hepatocellular Adenoma 1 (2%)
Histiocytic Sarcoma 1 (2%) 1 (2%)
Leiomyosarcoma, Metastatic, Intestine Large,
Colon 1 (2%)
Sarcoma, Metastatic, Uncertain Primary Site 1 (2%)
Schwannoma Malignant, Metastatic, Heart 1 (2%)
Mesentery (11) (7) (5) (8)
Fat, Leiomyosarcoma, Metastatic, Intestine
Large, Colon 1 (13%)
Fat, Sarcoma 1 (14%)
Oral Mucosa (2) (1)
Pharyngeal, Squamous Cell Carcinoma 1 (100%)
Pancreas (50) (50) (50) (49)
Leiomyosarcoma, Metastatic, Intestine Large,
Colon 1 (2%)
Acinus, Adenocarcinoma 2 (4%)
Acinus, Adenoma 1 (2%)
Acinus, Carcinoma 1 (2%)
Stomach, Forestomach (50) (50) (50) (50)
Sarcoma, Metastatic, Uncertain Primary Site 1 (2%)
Squamous Cell Papilloma 1 (2%) 1 (2%)
Stomach, Glandular (50) (50) (50) (50)
NTP Experiment-Test: 88007-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC SODIUM NITRITE Date: 10/18/99
Route: DOSED WATER Time: 13:52:35
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0.0% 0.075% 0.15% 0.30%
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - cont
Carcinoid Tumor Benign 1 (2%)
Leiomyosarcoma 1 (2%)
Sarcoma, Metastatic, Uncertain Primary Site 1 (2%)
Schwannoma Malignant, Metastatic, Heart 1 (2%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Blood Vessel (50) (50) (50) (50)
Heart (50) (50) (50) (50)
Schwannoma Malignant 1 (2%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (50) (50) (50) (50)
Adenoma 1 (2%)
Adrenal Medulla (50) (50) (50) (50)
Pheochromocytoma Malignant 1 (2%) 1 (2%) 1 (2%)
Pheochromocytoma Benign 5 (10%) 10 (20%) 6 (12%) 9 (18%)
Bilateral, Pheochromocytoma Benign 1 (2%) 1 (2%)
Islets, Pancreatic (50) (50) (50) (49)
Adenoma 4 (8%) 1 (2%)
Carcinoma 1 (2%) 2 (4%)
Parathyroid Gland (45) (48) (49) (48)
Adenoma 1 (2%)
Pituitary Gland (50) (49) (50) (50)
Sarcoma NOS 1 (2%)
Pars Distalis, Adenoma 13 (26%) 13 (27%) 15 (30%) 10 (20%)
Pars Intermedia, Adenoma 1 (2%)
Thyroid Gland (50) (50) (50) (50)
C-Cell, Adenoma 12 (24%) 8 (16%) 7 (14%) 4 (8%)
C-Cell, Adenoma, Multiple 1 (2%)
C-Cell, Carcinoma 2 (4%) 2 (4%) 1 (2%)
Follicular Cell, Adenoma 1 (2%) 1 (2%) 1 (2%)
Follicular Cell, Carcinoma 1 (2%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
NTP Experiment-Test: 88007-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC SODIUM NITRITE Date: 10/18/99
Route: DOSED WATER Time: 13:52:35
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0.0% 0.075% 0.15% 0.30%
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Epididymis (50) (50) (50) (50)
Preputial Gland (50) (50) (50) (50)
Adenoma 3 (6%) 1 (2%) 2 (4%)
Carcinoma 5 (10%) 1 (2%) 7 (14%) 5 (10%)
Prostate (50) (50) (50) (50)
Seminal Vesicle (50) (50) (50) (49)
Testes (50) (50) (50) (50)
Bilateral, Interstitial Cell, Adenoma 37 (74%) 44 (88%) 38 (76%) 40 (80%)
Interstitial Cell, Adenoma 10 (20%) 2 (4%) 9 (18%) 6 (12%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (50) (50) (50) (50)
Histiocytic Sarcoma 1 (2%)
Lymph Node (5) (4) (4) (2)
Carcinoma, Metastatic, Thyroid Gland 1 (20%)
Deep Cervical, Histiocytic Sarcoma 1 (25%)
Pancreatic, Sarcoma, Metastatic, Uncertain
Primary Site 1 (50%)
Lymph Node, Mandibular (48) (50) (50) (50)
Histiocytic Sarcoma 1 (2%)
Lymph Node, Mesenteric (50) (50) (50) (50)
Sarcoma, Metastatic, Uncertain Primary Site 1 (2%)
Spleen (50) (50) (50) (50)
Fibroma 1 (2%)
Fibrosarcoma 1 (2%)
Histiocytic Sarcoma 1 (2%)
Sarcoma, Metastatic, Uncertain Primary Site 1 (2%)
Thymus (50) (49) (49) (48)
Histiocytic Sarcoma 1 (2%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (45) (47) (47) (47)
Carcinoma 1 (2%)
Fibroadenoma 3 (7%) 5 (11%) 2 (4%)
Fibroadenoma, Multiple 1 (2%)
Skin (49) (50) (50) (50)
Basal Cell Adenoma 1 (2%)
Basal Cell Carcinoma 1 (2%)
Fibroma 1 (2%) 5 (10%) 3 (6%)
Fibroma, Multiple 1 (2%)
Fibrosarcoma 1 (2%) 2 (4%)
Keratoacanthoma 2 (4%) 3 (6%) 4 (8%) 3 (6%)
NTP Experiment-Test: 88007-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC SODIUM NITRITE Date: 10/18/99
Route: DOSED WATER Time: 13:52:35
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0.0% 0.075% 0.15% 0.30%
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM - cont
Keratoacanthoma, Multiple 1 (2%)
Lipoma 1 (2%)
Sarcoma 1 (2%)
Squamous Cell Carcinoma 1 (2%)
Trichoepithelioma 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (50) (50) (50) (50)
Osteosarcoma 1 (2%)
Maxilla, Osteosarcoma 1 (2%)
Skeletal Muscle (1) (1)
Sarcoma, Metastatic, Uncertain Primary Site 1 (100%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (50) (50) (50)
Histiocytic Sarcoma 1 (2%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (50) (50) (50)
Alveolar/Bronchiolar Adenoma 2 (4%) 3 (6%) 2 (4%) 2 (4%)
Alveolar/Bronchiolar Carcinoma 1 (2%)
Carcinoma, Metastatic, Thyroid Gland 1 (2%)
Histiocytic Sarcoma 1 (2%)
Leiomyosarcoma, Metastatic, Intestine Large,
Colon 1 (2%)
Schwannoma Malignant, Metastatic, Heart 1 (2%)
Trachea (50) (50) (50) (50)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Harderian Gland (2)
Histiocytic Sarcoma 1 (50%)
Zymbal's Gland (1) (2)
Carcinoma 1 (100%) 2 (100%)
____________________________________________________________________________________________________________________________________
NTP Experiment-Test: 88007-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC SODIUM NITRITE Date: 10/18/99
Route: DOSED WATER Time: 13:52:35
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0.0% 0.075% 0.15% 0.30%
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (50) (50) (50)
Renal Tubule, Adenoma 1 (2%)
Urinary Bladder (49) (50) (50) (50)
Transitional Epithelium, Papilloma 1 (2%)
____________________________________________________________________________________________________________________________________
SYSTEMIC LESIONS
Multiple Organs *(50) *(50) *(50) *(50)
Histiocytic Sarcoma 1 (2%) 1 (2%)
Leukemia Mononuclear 17 (34%) 12 (24%) 7 (14%) 3 (6%)
Lymphoma Malignant 1 (2%)
Mesothelioma Malignant 3 (6%) 3 (6%) 4 (8%) 1 (2%)
____________________________________________________________________________________________________________________________________
* Number of animals with any tissue examined microscopically
Page 11
NTP Experiment-Test: 88007-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC SODIUM NITRITE Date: 10/18/99
Route: DOSED WATER Time: 13:52:35
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0.0% 0.075% 0.15% 0.30%
____________________________________________________________________________________________________________________________________
TUMOR SUMMARY
Total Animals with Primary Neoplasms (b) 49 49 50 50
Total Primary Neoplasms 129 120 123 107
Total Animals with Benign Neoplasms 47 48 49 49
Total Benign Neoplasms 93 94 99 86
Total Animals with Malignant Neoplasms 30 22 21 20
Total Malignant Neoplasms 36 26 24 21
Total Animals with Metastatic Neoplasms 2 2
Total Metastatic Neoplasm 6 11
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
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