TDMS Study 05188-05 Pathology Tables
NTP Experiment-Test: 05188-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC SODIUM XYLENESULFONATE Date: 04/04/96
Route: SKIN APPLICATION Time: 04:28:16
Facility: Battelle Columbus Laboratory
Chemical CAS #: 1300-72-7
Lock Date: 07/13/93
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: 05188-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC SODIUM XYLENESULFONATE Date: 04/04/96
Route: SKIN APPLICATION Time: 04:28:16
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 MG/KG 60 MG/KG 120 240
MG/KG MG/KG
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially in Study 50 50 50 50
Early Deaths
Moribund Sacrifice 14 10 15 12
Natural Death 13 24 18 22
Accidently Killed 1
Survivors
Terminal Sacrifice 22 15 17 16
Natural Death 1
Animals Examined Microscopically 50 50 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Esophagus (50) (35) (33) (50)
Periesophageal Tissue, Lipoma 1 (3%) 1 (3%)
Intestine Small, Duodenum (50) (35) (33) (50)
Liver (50) (35) (33) (50)
Mesentery (2) (4) (4) (4)
Oral Mucosa (1) (2)
Gingival, Squamous Cell Carcinoma 1 (100%)
Pancreas (50) (35) (33) (50)
Stomach, Glandular (50) (35) (33) (50)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (50) (35) (33) (50)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (50) (35) (33) (50)
Adenoma 1 (2%) 1 (3%) 1 (2%)
Adrenal Medulla (50) (35) (33) (50)
Pheochromocytoma Benign 1 (2%) 1 (3%) 2 (4%)
Islets, Pancreatic (50) (35) (33) (50)
Adenoma 1 (3%)
Carcinoma 1 (2%)
Pituitary Gland (50) (35) (33) (50)
Pars Distalis, Adenoma 29 (58%) 16 (46%) 19 (58%) 27 (54%)
Pars Distalis, Adenoma, Multiple 5 (10%) 1 (3%) 2 (4%)
Pars Distalis, Carcinoma 1 (2%)
Pars Intermedia, Adenoma 1 (2%)
Thyroid Gland (50) (35) (33) (50)
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NTP Experiment-Test: 05188-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC SODIUM XYLENESULFONATE Date: 04/04/96
Route: SKIN APPLICATION Time: 04:28:16
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 MG/KG 60 MG/KG 120 240
MG/KG MG/KG
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM - cont
C-Cell, Adenoma 10 (20%) 1 (3%) 2 (6%) 7 (14%)
C-Cell, Adenoma, Multiple 1 (2%)
Follicular Cell, Adenoma 1 (2%) 2 (6%) 1 (2%)
Follicular Cell, Carcinoma 1 (2%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Clitoral Gland (49) (50) (50) (50)
Adenoma 1 (2%) 3 (6%) 3 (6%)
Carcinoma 1 (2%) 2 (4%)
Bilateral, Adenoma 1 (2%)
Ovary (50) (35) (33) (50)
Uterus (50) (35) (33) (50)
Fibroma 1 (2%)
Polyp Stromal 2 (4%) 1 (3%) 1 (3%) 3 (6%)
Sarcoma Stromal 1 (3%) 1 (3%)
Vagina (1) (1) (1)
Squamous Cell Carcinoma 1 (100%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (50) (35) (33) (48)
Lymph Node (45) (32) (27) (43)
Lymph Node, Mandibular (50) (35) (33) (50)
Lymph Node, Mesenteric (49) (35) (33) (48)
Spleen (50) (35) (33) (50)
Thymus (49) (35) (31) (49)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (50) (35) (33) (50)
Carcinoma 1 (2%) 1 (3%) 1 (2%)
Fibroadenoma 12 (24%) 4 (11%) 8 (24%) 6 (12%)
Fibroadenoma, Multiple 4 (8%) 3 (6%)
Skin (50) (50) (50) (50)
Pinna, Squamous Cell Papilloma 1 (2%)
Subcutaneous Tissue, Lipoma 1 (2%)
Subcutaneous Tissue, Sarcoma 1 (2%)
Subcutaneous Tissue, Schwannoma Malignant 1 (2%)
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NTP Experiment-Test: 05188-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC SODIUM XYLENESULFONATE Date: 04/04/96
Route: SKIN APPLICATION Time: 04:28:16
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 MG/KG 60 MG/KG 120 240
MG/KG MG/KG
____________________________________________________________________________________________________________________________________
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (50) (35) (33) (48)
Humerus, Osteosarcoma 1 (2%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (35) (33) (50)
Astrocytoma Malignant 1 (2%) 1 (3%)
Carcinoma, Metastatic, Pituitary Gland 1 (2%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (35) (33) (50)
Alveolar/Bronchiolar Adenoma 1 (2%)
Osteosarcoma, Metastatic, Bone 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Zymbal's Gland (1)
Carcinoma 1 (100%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (35) (33) (50)
Lipoma 1 (3%)
Urinary Bladder (50) (35) (33) (50)
____________________________________________________________________________________________________________________________________
SYSTEMIC LESIONS
Multiple Organs *(50) *(50) *(50) *(50)
Leukemia Mononuclear 17 (34%) 5 (10%) 9 (18%) 10 (20%)
Mesothelioma Benign 1 (2%)
____________________________________________________________________________________________________________________________________
* Number of animals with any tissue examined microscopically
Page 4
NTP Experiment-Test: 05188-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC SODIUM XYLENESULFONATE Date: 04/04/96
Route: SKIN APPLICATION Time: 04:28:16
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 MG/KG 60 MG/KG 120 240
MG/KG MG/KG
____________________________________________________________________________________________________________________________________
TUMOR SUMMARY
Total Animals with Primary Neoplasms (b) 45 25 27 41
Total Primary Neoplasms 93 40 50 70
Total Animals with Benign Neoplasms 40 23 26 33
Total Benign Neoplasms 69 32 37 55
Total Animals with Malignant Neoplasms 23 8 11 15
Total Malignant Neoplasms 24 8 13 15
Total Animals with Metastatic Neoplasms 2
Total Metastatic Neoplasm 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
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NTP Experiment-Test: 05188-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC SODIUM XYLENESULFONATE Date: 04/04/96
Route: SKIN APPLICATION Time: 04:28:16
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 MG/KG 60 MG/KG 120 240
MG/KG MG/KG
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially in Study 50 50 50 50
Early Deaths
Natural Death 15 8 19 10
Moribund Sacrifice 28 25 22 30
Survivors
Terminal Sacrifice 7 17 9 10
Animals Examined Microscopically 50 50 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Intestine Large, Colon (50) (33) (41) (50)
Intestine Large, Cecum (50) (33) (41) (50)
Intestine Small, Duodenum (50) (33) (41) (50)
Carcinoma, Metastatic, Kidney 1 (2%)
Leiomyosarcoma, Metastatic, Stomach,
Forestomach 1 (2%)
Sarcoma, Metastatic, Mesentery 1 (2%)
Intestine Small, Jejunum (50) (33) (41) (50)
Carcinoma 1 (2%) 1 (2%)
Leiomyosarcoma 1 (3%)
Leiomyosarcoma, Metastatic, Stomach,
Forestomach 1 (2%)
Intestine Small, Ileum (50) (33) (41) (50)
Liver (50) (45) (47) (50)
Carcinoma, Metastatic, Kidney 1 (2%)
Hepatocellular Carcinoma 1 (2%)
Histiocytic Sarcoma 1 (2%) 1 (2%)
Leiomyosarcoma, Metastatic, Intestine Small,
Jejunum 1 (2%)
Leiomyosarcoma, Metastatic, Stomach,
Forestomach 1 (2%)
Mesentery (8) (7) (9) (8)
Carcinoma, Metastatic, Kidney 1 (14%) 1 (11%)
Histiocytic Sarcoma 1 (13%)
Leiomyosarcoma, Metastatic, Intestine Small,
Jejunum 1 (14%)
Leiomyosarcoma, Metastatic, Stomach,
Forestomach 1 (11%)
Sarcoma 1 (11%)
Oral Mucosa (2) (1) (3) (6)
Gingival, Squamous Cell Carcinoma 1 (50%) 1 (17%)
Pharyngeal, Squamous Cell Carcinoma 1 (17%)
Pancreas (50) (33) (41) (50)
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NTP Experiment-Test: 05188-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC SODIUM XYLENESULFONATE Date: 04/04/96
Route: SKIN APPLICATION Time: 04:28:16
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 MG/KG 60 MG/KG 120 240
MG/KG MG/KG
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - cont
Carcinoma, Metastatic, Kidney 1 (3%) 1 (2%)
Histiocytic Sarcoma 1 (2%) 1 (2%)
Leiomyosarcoma, Metastatic, Intestine Small,
Jejunum 1 (3%)
Leiomyosarcoma, Metastatic, Stomach,
Forestomach 1 (2%)
Mixed Tumor Benign 1 (2%)
Stomach, Forestomach (50) (33) (41) (50)
Leiomyosarcoma 1 (2%)
Stomach, Glandular (50) (33) (41) (50)
Leiomyosarcoma 1 (2%)
Sarcoma, Metastatic, Mesentery 1 (2%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (50) (33) (41) (50)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (50) (33) (41) (50)
Adenoma 1 (2%)
Histiocytic Sarcoma 1 (2%)
Leiomyosarcoma, Metastatic, Stomach,
Forestomach 1 (2%)
Adrenal Medulla (50) (33) (41) (50)
Pheochromocytoma Malignant 1 (2%)
Pheochromocytoma Benign 8 (16%) 5 (15%) 3 (7%) 9 (18%)
Islets, Pancreatic (50) (33) (41) (50)
Adenoma 5 (10%) 3 (6%)
Carcinoma 1 (3%) 1 (2%)
Carcinoma, Metastatic, Kidney 1 (3%) 1 (2%)
Leiomyosarcoma, Metastatic, Intestine Small,
Jejunum 1 (3%)
Pituitary Gland (50) (33) (41) (50)
Adenoma, Multiple 1 (2%)
Pars Distalis, Adenoma 34 (68%) 26 (79%) 30 (73%) 31 (62%)
Pars Distalis, Adenoma, Multiple 9 (18%) 1 (3%) 4 (10%) 5 (10%)
Pars Distalis, Carcinoma 1 (2%)
Pars Distalis, Craniopharyngioma 1 (2%)
Thyroid Gland (50) (33) (41) (50)
Bilateral, C-Cell, Adenoma 1 (2%) 1 (2%)
Bilateral, C-Cell, Carcinoma 1 (2%)
C-Cell, Adenoma 8 (16%) 3 (9%) 1 (2%) 5 (10%)
Follicular Cell, Carcinoma 1 (2%) 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
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NTP Experiment-Test: 05188-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC SODIUM XYLENESULFONATE Date: 04/04/96
Route: SKIN APPLICATION Time: 04:28:16
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 MG/KG 60 MG/KG 120 240
MG/KG MG/KG
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
Peritoneum (3) (1) (2)
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Epididymis (50) (33) (41) (50)
Preputial Gland (50) (33) (40) (50)
Adenoma 1 (2%) 1 (3%)
Carcinoma 1 (3%)
Prostate (50) (33) (41) (50)
Seminal Vesicle (50) (33) (41) (50)
Carcinoma, Metastatic, Kidney 1 (3%) 1 (2%)
Leiomyosarcoma, Metastatic, Intestine Small,
Jejunum 1 (3%)
Leiomyosarcoma, Metastatic, Stomach,
Forestomach 1 (2%)
Testes (50) (33) (41) (50)
Bilateral, Interstitial Cell, Adenoma 11 (22%) 2 (6%) 5 (12%) 17 (34%)
Interstitial Cell, Adenoma 13 (26%) 6 (18%) 8 (20%) 13 (26%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (50) (32) (41) (50)
Histiocytic Sarcoma 1 (2%) 1 (2%)
Lymph Node (41) (25) (31) (41)
Mediastinal, Carcinoma, Metastatic, Kidney 1 (4%) 1 (3%)
Mediastinal, Histiocytic Sarcoma 1 (3%) 1 (2%)
Renal, Carcinoma, Metastatic, Kidney 1 (3%)
Lymph Node, Mandibular (50) (33) (40) (49)
Histiocytic Sarcoma 1 (3%)
Lymph Node, Mesenteric (50) (33) (41) (50)
Carcinoma, Metastatic, Kidney 1 (3%) 1 (2%)
Leiomyosarcoma, Metastatic, Intestine Small,
Jejunum 1 (3%)
Spleen (50) (46) (47) (50)
Fibroma 1 (2%)
Histiocytic Sarcoma 1 (2%) 1 (2%)
Leiomyosarcoma, Metastatic, Stomach,
Forestomach 1 (2%)
Thymus (46) (31) (41) (50)
Thymoma Benign 1 (2%)
____________________________________________________________________________________________________________________________________
Page 8
NTP Experiment-Test: 05188-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC SODIUM XYLENESULFONATE Date: 04/04/96
Route: SKIN APPLICATION Time: 04:28:16
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 MG/KG 60 MG/KG 120 240
MG/KG MG/KG
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (50) (32) (40) (50)
Carcinoma 1 (3%)
Fibroadenoma 1 (2%)
Skin (50) (50) (50) (50)
Basal Cell Adenoma 1 (2%)
Keratoacanthoma 1 (2%) 1 (2%)
Squamous Cell Papilloma 1 (2%) 1 (2%)
Sebaceous Gland, Skin, Site of Application,
Carcinoma 1 (2%)
Skin, Site of Application, Basal Cell Adenoma 1 (2%) 1 (2%)
Subcutaneous Tissue, Fibroma 1 (2%) 1 (2%) 3 (6%)
Subcutaneous Tissue, Histiocytic Sarcoma 1 (2%)
Subcutaneous Tissue, Schwannoma Malignant 1 (2%)
Subcutaneous Tissue, Pinna, Melanoma
Malignant 1 (2%)
Subcutaneous Tissue, Skin, Site of
Application, Fibroma, Multiple 1 (2%)
Subcutaneous Tissue, Skin, Site of
Application, Fibrous Histiocytoma 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (50) (32) (41) (50)
Osteosarcoma 1 (2%)
Rib, Osteosarcoma 1 (3%)
Skeletal Muscle (3) (2)
Carcinoma, Metastatic, Kidney 1 (33%) 1 (50%)
Histiocytic Sarcoma 1 (50%)
Leiomyosarcoma, Metastatic, Intestine Small,
Jejunum 1 (33%)
Osteosarcoma, Metastatic, Bone 1 (33%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (33) (41) (50)
Astrocytoma Malignant 1 (2%) 1 (3%)
Carcinoma, Metastatic, Pituitary Gland 1 (2%)
Oligodendroglioma Malignant 1 (2%)
____________________________________________________________________________________________________________________________________
Page 9
NTP Experiment-Test: 05188-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC SODIUM XYLENESULFONATE Date: 04/04/96
Route: SKIN APPLICATION Time: 04:28:16
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 MG/KG 60 MG/KG 120 240
MG/KG MG/KG
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (33) (41) (50)
Alveolar/Bronchiolar Adenoma 1 (2%)
Alveolar/Bronchiolar Carcinoma 2 (4%)
Carcinoma, Metastatic, Kidney 1 (3%) 1 (2%)
Carcinoma, Metastatic, Skin 1 (2%)
Histiocytic Sarcoma 1 (2%) 1 (2%)
Leiomyosarcoma, Metastatic, Intestine Small,
Jejunum 1 (3%)
Osteosarcoma, Metastatic, Bone 1 (2%)
Mediastinum, Osteosarcoma, Metastatic, Bone 1 (3%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Harderian Gland (1) (1) (1)
Squamous Cell Carcinoma, Metastatic, Oral
Mucosa 1 (100%)
Zymbal's Gland (2) (2)
Adenoma 1 (50%)
Carcinoma 1 (50%) 2 (100%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (33) (41) (50)
Adenoma, Tubular 1 (2%)
Carcinoma, Metastatic, Kidney 1 (3%)
Sarcoma 1 (3%)
Renal Tubule, Adenoma 1 (2%) 1 (2%)
Renal Tubule, Carcinoma 1 (3%) 1 (2%)
Urinary Bladder (50) (33) (41) (50)
Transitional Epithelium, Carcinoma 1 (2%)
Transitional Epithelium, Papilloma 1 (2%)
____________________________________________________________________________________________________________________________________
SYSTEMIC LESIONS
Multiple Organs *(50) *(50) *(50) *(50)
Histiocytic Sarcoma 1 (2%) 1 (2%)
Leukemia Mononuclear 12 (24%) 24 (48%) 15 (30%) 25 (50%)
Mesothelioma Malignant 1 (2%)
____________________________________________________________________________________________________________________________________
* Number of animals with any tissue examined microscopically
Page 10
NTP Experiment-Test: 05188-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC SODIUM XYLENESULFONATE Date: 04/04/96
Route: SKIN APPLICATION Time: 04:28:16
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 MG/KG 60 MG/KG 120 240
MG/KG MG/KG
____________________________________________________________________________________________________________________________________
TUMOR SUMMARY
Total Animals with Primary Neoplasms (b) 50 45 46 49
Total Primary Neoplasms 120 80 85 127
Total Animals with Benign Neoplasms 49 29 39 49
Total Benign Neoplasms 98 47 58 92
Total Animals with Malignant Neoplasms 18 28 25 30
Total Malignant Neoplasms 22 33 27 35
Total Animals with Metastatic Neoplasms 7 4 4 3
Total Metastatic Neoplasm 42 33 21 22
Total Animals with Malignant Neoplasms 5 1 2
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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