TDMS Study 05099-08 Pathology Tables
NTP Experiment-Test: 05099-08 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC SALICYLAZOSULFAPYRIDINE Date: 04/03/96
Route: GAVAGE Time: 20:30:27
Facility: Southern Research Institute
Chemical CAS #: 599-79-1
Lock Date: 04/19/94
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: 05099-08 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC SALICYLAZOSULFAPYRIDINE Date: 04/03/96
Route: GAVAGE Time: 20:30:27
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 MG/KG 675 1350 2700
MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially in Study 60 60 60 60
Scheduled Sacrifice 10 10 10 10
Early Deaths
Accidently Killed 1 1
Moribund Sacrifice 5 6 8 6
Natural Death 2 3 4 4
Dosing Accident 1 2
Survivors
Terminal Sacrifice 41 41 36 38
Accidently Killed 1
Animals Examined Microscopically 60 60 60 60
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Intestine Large, Rectum (59) (60) (59) (56)
Histiocytic Sarcoma 1 (2%)
Leiomyosarcoma 1 (2%)
Intestine Large, Cecum (59) (59) (58) (56)
Leiomyosarcoma 1 (2%)
Intestine Small, Jejunum (59) (59) (58) (56)
Hemangiosarcoma 1 (2%)
Intestine Small, Ileum (59) (59) (58) (55)
Liver (60) (60) (60) (59)
Hemangioma 1 (2%)
Hemangiosarcoma 2 (3%) 1 (2%)
Hepatocellular Carcinoma 3 (5%) 8 (13%) 9 (15%) 9 (15%)
Hepatocellular Carcinoma, Multiple 2 (3%) 1 (2%) 1 (2%)
Hepatocellular Adenoma 10 (17%) 16 (27%) 14 (23%) 16 (27%)
Hepatocellular Adenoma, Multiple 3 (5%) 12 (20%) 12 (20%) 14 (24%)
Histiocytic Sarcoma 1 (2%) 2 (3%)
Osteosarcoma, Metastatic, Bone 1 (2%)
Mesentery (7) (11) (3) (5)
Histiocytic Sarcoma 1 (33%)
Leiomyosarcoma, Metastatic, Uterus 1 (33%)
Pancreas (60) (59) (60) (59)
Hemangioma 1 (2%)
Salivary Glands (59) (60) (60) (60)
Stomach, Forestomach (60) (59) (60) (59)
Squamous Cell Papilloma 5 (8%) 2 (3%) 1 (2%)
Stomach, Glandular (60) (59) (60) (59)
____________________________________________________________________________________________________________________________________
Page 2
NTP Experiment-Test: 05099-08 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC SALICYLAZOSULFAPYRIDINE Date: 04/03/96
Route: GAVAGE Time: 20:30:27
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 MG/KG 675 1350 2700
MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (60) (60) (60) (60)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (60) (60) (60) (60)
Adenoma 1 (2%)
Leiomyosarcoma, Metastatic, Intestine Large,
Rectum 1 (2%)
Adrenal Medulla (60) (60) (60) (60)
Pheochromocytoma Benign 1 (2%) 2 (3%) 1 (2%)
Pituitary Gland (59) (55) (60) (56)
Pars Distalis, Adenoma 7 (12%) 7 (13%) 7 (12%) 2 (4%)
Pars Intermedia, Adenoma 1 (2%) 2 (4%)
Thyroid Gland (60) (60) (60) (60)
Histiocytic Sarcoma 1 (2%)
Follicular Cell, Adenoma 1 (2%) 2 (3%) 1 (2%)
Follicular Cell, Carcinoma 1 (2%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Ovary (59) (59) (59) (59)
Cystadenoma 2 (3%) 5 (8%) 5 (8%) 2 (3%)
Granulosa Cell Tumor Malignant 1 (2%)
Granulosa Cell Tumor Benign 1 (2%)
Leiomyosarcoma, Metastatic, Uterus 1 (2%)
Luteoma 1 (2%) 3 (5%) 1 (2%)
Teratoma Malignant 1 (2%)
Thecoma Malignant 1 (2%)
Uterus (60) (60) (60) (59)
Histiocytic Sarcoma 1 (2%) 3 (5%)
Leiomyosarcoma 1 (2%)
Polyp Stromal 1 (2%)
____________________________________________________________________________________________________________________________________
Page 3
NTP Experiment-Test: 05099-08 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC SALICYLAZOSULFAPYRIDINE Date: 04/03/96
Route: GAVAGE Time: 20:30:27
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 MG/KG 675 1350 2700
MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (60) (60) (60) (60)
Hemangiosarcoma 1 (2%)
Histiocytic Sarcoma 1 (2%)
Lymph Node (8) (7) (11) (4)
Iliac, Histiocytic Sarcoma 1 (13%)
Inguinal, Histiocytic Sarcoma 1 (9%)
Inguinal, Mast Cell Tumor NOS 1 (9%)
Mediastinal, Histiocytic Sarcoma 1 (13%)
Renal, Histiocytic Sarcoma 1 (13%)
Renal, Teratoma Malignant, Metastatic, Ovary 1 (9%)
Lymph Node, Mandibular (59) (60) (60) (59)
Histiocytic Sarcoma 1 (2%)
Lymph Node, Mesenteric (59) (60) (60) (58)
Histiocytic Sarcoma 1 (2%)
Spleen (60) (60) (60) (59)
Hemangioma 1 (2%)
Hemangiosarcoma 2 (3%) 4 (7%) 1 (2%)
Histiocytic Sarcoma 1 (2%)
Thymus (60) (59) (59) (59)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (60) (60) (60) (60)
Adenoacanthoma 1 (2%)
Carcinoma 1 (2%)
Skin (60) (60) (60) (60)
Squamous Cell Papilloma 2 (3%)
Subcutaneous Tissue, Fibrosarcoma 1 (2%) 1 (2%) 1 (2%)
Subcutaneous Tissue, Hemangioma 1 (2%)
Subcutaneous Tissue, Hemangiosarcoma 1 (2%) 1 (2%)
Subcutaneous Tissue, Histiocytic Sarcoma 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (60) (60) (60) (60)
Cranium, Osteosarcoma 1 (2%)
Vertebra, Osteosarcoma 1 (2%)
Skeletal Muscle (1) (2) (1)
Fibrosarcoma 1 (50%)
Leiomyosarcoma, Metastatic, Uterus 1 (50%)
____________________________________________________________________________________________________________________________________
Page 4
NTP Experiment-Test: 05099-08 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC SALICYLAZOSULFAPYRIDINE Date: 04/03/96
Route: GAVAGE Time: 20:30:27
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 MG/KG 675 1350 2700
MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (60) (60) (60) (60)
Osteosarcoma, Metastatic, Bone 1 (2%)
Spinal Cord (2) (1) (2)
Osteosarcoma, Metastatic, Bone 1 (100%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (60) (60) (60) (60)
Adenoacanthoma, Metastatic, Mammary Gland 1 (2%)
Alveolar/Bronchiolar Adenoma 3 (5%) 3 (5%) 3 (5%) 4 (7%)
Alveolar/Bronchiolar Carcinoma 1 (2%) 1 (2%)
Alveolar/Bronchiolar Carcinoma, Multiple 1 (2%)
Granulosa Cell Tumor Malignant, Metastatic,
Ovary 1 (2%)
Hepatocellular Carcinoma, Metastatic, Liver 2 (3%) 1 (2%)
Histiocytic Sarcoma 1 (2%) 1 (2%)
Leiomyosarcoma, Metastatic, Uterus 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Harderian Gland (2) (1) (2)
Adenoma 2 (100%) 1 (100%) 2 (100%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (60) (60) (60) (59)
Histiocytic Sarcoma 1 (2%)
Urinary Bladder (60) (60) (60) (60)
____________________________________________________________________________________________________________________________________
SYSTEMIC LESIONS
Multiple Organs *(60) *(60) *(60) *(60)
Histiocytic Sarcoma 2 (3%) 4 (7%)
Lymphoma Malignant 13 (22%) 6 (10%) 7 (12%) 6 (10%)
____________________________________________________________________________________________________________________________________
* Number of animals with any tissue examined microscopically
Page 5
NTP Experiment-Test: 05099-08 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC SALICYLAZOSULFAPYRIDINE Date: 04/03/96
Route: GAVAGE Time: 20:30:27
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 MG/KG 675 1350 2700
MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
TUMOR SUMMARY
Total Animals with Primary Neoplasms (b) 37 38 43 38
Total Primary Neoplasms 61 73 85 70
Total Animals with Benign Neoplasms 25 33 35 34
Total Benign Neoplasms 38 49 50 48
Total Animals with Malignant Neoplasms 20 19 26 18
Total Malignant Neoplasms 23 24 34 22
Total Animals with Metastatic Neoplasms 2 3 3 2
Total Metastatic Neoplasm 2 4 6 2
Total Animals with Malignant Neoplasms
Uncertain Primary Site
Total Animals with Neoplasms Uncertain-
Benign or Malignant 1
Total Uncertain Neoplasms 1
____________________________________________________________________________________________________________________________________
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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NTP Experiment-Test: 05099-08 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC SALICYLAZOSULFAPYRIDINE Date: 04/03/96
Route: GAVAGE Time: 20:30:27
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 MG/KG 0 MG/KG 675 1350 2700
FEED RTD MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially in Study 60 60 60 60 60
Scheduled Sacrifice 10 10 10 10 10
Early Deaths
Moribund Sacrifice 5 3 4 3 4
Natural Death 3 1 5 6
Dosing Accident 2 1
Survivors
Terminal Sacrifice 40 45 41 41 46
Animals Examined Microscopically 60 60 60 60 60
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Intestine Large, Colon (58) (60) (57) (57) (60)
Leiomyosarcoma 1 (2%)
Intestine Large, Cecum (57) (60) (56) (56) (60)
Adenocarcinoma 1 (2%)
Intestine Small, Jejunum (57) (60) (56) (57) (60)
Adenocarcinoma 1 (2%)
Intestine Small, Ileum (57) (60) (56) (56) (60)
Liver (60) (60) (60) (60) (60)
Hemangioma 1 (2%)
Hemangiosarcoma 2 (3%)
Hepatoblastoma 1 (2%)
Hepatocellular Carcinoma 12 (20%) 6 (10%) 11 (18%) 19 (32%) 8 (13%)
Hepatocellular Carcinoma, Multiple 1 (2%) 4 (7%) 5 (8%)
Hepatocellular Adenoma 14 (23%) 9 (15%) 13 (22%) 13 (22%) 17 (28%)
Hepatocellular Adenoma, Multiple 1 (2%) 21 (35%) 15 (25%) 27 (45%)
Histiocytic Sarcoma 1 (2%)
Osteosarcoma, Metastatic, Bone 1 (2%)
Mesentery (4) (2) (4) (1) (1)
Pancreas (60) (60) (60) (60) (60)
Carcinoma, Metastatic, Lung 1 (2%)
Acinus, Adenoma 1 (2%)
Stomach, Forestomach (60) (60) (60) (59) (60)
Squamous Cell Papilloma 4 (7%) 5 (8%) 1 (2%)
Stomach, Glandular (60) (60) (60) (58) (60)
Adenoma 1 (2%)
____________________________________________________________________________________________________________________________________
Page 7
NTP Experiment-Test: 05099-08 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC SALICYLAZOSULFAPYRIDINE Date: 04/03/96
Route: GAVAGE Time: 20:30:27
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 MG/KG 0 MG/KG 675 1350 2700
FEED RTD MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Blood Vessel (60) (60) (60) (60) (60)
Aorta, Alveolar/Bronchiolar Carcinoma,
Metastatic, Lung 1 (2%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (60) (60) (59) (59) (60)
Carcinoma, Metastatic, Lung 1 (2%)
Capsule, Adenoma 1 (2%) 2 (3%)
Adrenal Medulla (60) (60) (59) (59) (60)
Carcinoma, Metastatic, Lung 1 (2%)
Islets, Pancreatic (60) (60) (60) (60) (60)
Adenoma 1 (2%) 1 (2%)
Pituitary Gland (54) (56) (56) (57) (57)
Pars Distalis, Adenoma 1 (2%)
Pars Intermedia, Adenoma 1 (2%)
Pars Intermedia, Carcinoma 1 (2%)
Thyroid Gland (60) (60) (60) (60) (60)
Follicular Cell, Adenoma 1 (2%) 2 (3%) 1 (2%)
Follicular Cell, Carcinoma 1 (2%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Epididymis (60) (60) (60) (60) (60)
Histiocytic Sarcoma 1 (2%)
Preputial Gland (59) (60) (59) (59) (60)
Adenoma 1 (2%)
Prostate (60) (60) (60) (60) (60)
Seminal Vesicle (60) (60) (60) (60) (60)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (60) (60) (60) (60) (60)
Histiocytic Sarcoma 1 (2%)
Lymph Node (3) (1) (3) (3) (4)
Mediastinal, Alveolar/Bronchiolar Carcinoma,
Metastatic, Lung 1 (33%)
Mediastinal, Histiocytic Sarcoma 1 (33%)
Page 8
NTP Experiment-Test: 05099-08 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC SALICYLAZOSULFAPYRIDINE Date: 04/03/96
Route: GAVAGE Time: 20:30:27
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 MG/KG 0 MG/KG 675 1350 2700
FEED RTD MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - cont
Pancreatic, Histiocytic Sarcoma 1 (33%)
Lymph Node, Mandibular (60) (59) (59) (59) (59)
Lymph Node, Mesenteric (60) (58) (60) (60) (60)
Hemangiosarcoma 1 (2%)
Histiocytic Sarcoma 1 (2%)
Spleen (60) (60) (60) (59) (60)
Hemangiosarcoma 1 (2%) 1 (2%) 1 (2%)
Histiocytic Sarcoma 1 (2%)
Thymus (54) (56) (53) (56) (56)
Carcinoma, Metastatic, Lung 1 (2%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Skin (60) (60) (60) (60) (60)
Subcutaneous Tissue, Fibrosarcoma 1 (2%)
Subcutaneous Tissue, Fibrous Histiocytoma 1 (2%)
Subcutaneous Tissue, Hemangiosarcoma 1 (2%)
Subcutaneous Tissue, Osteosarcoma,
Metastatic, Bone 1 (2%)
Subcutaneous Tissue, Plasma Cell Tumor Benign 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (60) (60) (60) (60) (60)
Vertebra, Osteosarcoma 1 (2%)
Skeletal Muscle (1)
Hemangiosarcoma 1 (100%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (60) (60) (60) (60) (60)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (60) (60) (60) (60) (60)
Alveolar/Bronchiolar Adenoma 10 (17%) 6 (10%) 10 (17%) 13 (22%) 4 (7%)
Alveolar/Bronchiolar Adenoma, Multiple 2 (3%) 3 (5%) 2 (3%)
Alveolar/Bronchiolar Carcinoma 3 (5%) 4 (7%) 8 (13%) 3 (5%) 4 (7%)
Alveolar/Bronchiolar Carcinoma, Multiple 1 (2%)
Carcinoma, Metastatic, Tissue NOS 1 (2%)
Hepatocellular Carcinoma, Metastatic, Liver 4 (7%) 1 (2%) 2 (3%)
Osteosarcoma, Metastatic, Bone 1 (2%)
Alveolar Epithelium, Alveolar/Bronchiolar
Page 9
NTP Experiment-Test: 05099-08 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC SALICYLAZOSULFAPYRIDINE Date: 04/03/96
Route: GAVAGE Time: 20:30:27
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 MG/KG 0 MG/KG 675 1350 2700
FEED RTD MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM - cont
Adenoma 1 (2%)
Mediastinum, Alveolar/Bronchiolar Carcinoma 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Harderian Gland (3) (3) (5) (1) (2)
Adenoma 2 (67%) 4 (80%) 1 (100%) 2 (100%)
Carcinoma 1 (33%) 2 (67%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (60) (60) (60) (60) (60)
Urinary Bladder (60) (60) (60) (60) (60)
Hemangioma 1 (2%)
____________________________________________________________________________________________________________________________________
SYSTEMIC LESIONS
Multiple Organs *(60) *(60) *(60) *(60) *(60)
Histiocytic Sarcoma 2 (3%)
Lymphoma Malignant 5 (8%) 2 (3%) 3 (5%) 1 (2%) 1 (2%)
Lymphoma Malignant Lymphocytic 1 (2%)
____________________________________________________________________________________________________________________________________
* Number of animals with any tissue examined microscopically
Page 10
NTP Experiment-Test: 05099-08 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC SALICYLAZOSULFAPYRIDINE Date: 04/03/96
Route: GAVAGE Time: 20:30:27
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 MG/KG 0 MG/KG 675 1350 2700
FEED RTD MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
TUMOR SUMMARY
Total Animals with Primary Neoplasms (b) 44 31 47 44 47
Total Primary Neoplasms 66 39 79 81 77
Total Animals with Benign Neoplasms 30 20 38 34 45
Total Benign Neoplasms 39 22 50 48 58
Total Animals with Malignant Neoplasms 25 16 26 30 14
Total Malignant Neoplasms 27 17 29 33 19
Total Animals with Metastatic Neoplasms 5 1 2 2 1
Total Metastatic Neoplasm 8 1 2 5 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
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