TDMS Study 05102-05 Pathology Tables
INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)
BENZETHONIUM CHLORIDE
NTP Experiment-Test: 05102-05 Report: PEIRPT05
Study Type: CHRONIC Date: 05/19/95
Route: DERMAL,SOLUTION Time: 18:13:29
Facility: Battelle Columbus Laboratory
Chemical CAS #: 121-54-0
Lock Date: 01/24/92
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: 05102-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC BENZETHONIUM CHLORIDE Date: 05/19/95
Route: DERMAL,SOLUTION Time: 18:13:29
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0MG/KG .15MG/KG 0.5MG/KG 1.5MG/KG
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially in Study 60 60 60 60
Scheduled Sacrifice 9 7 9 7
Early Deaths
Moribund Sacrifice 13 11 13 13
Natural Death 14 9 12 16
Survivors
Terminal Sacrifice 24 33 26 24
Animals Examined Microscopically 60 60 60 60
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ALIMENTARY SYSTEM
Intestine Small, Jejunum (1)
Liver (60) (60)
Mesentery (4) (4)
Fat, Liposarcoma 1 (25%)
Pancreas (60) (60)
Salivary Glands (60) (60)
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CARDIOVASCULAR SYSTEM
None
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ENDOCRINE SYSTEM
Adrenal Cortex (19) (21)
Adenoma 1 (5%)
Adrenal Medulla (10) (2)
Pheochromocytoma Benign 3 (30%)
Bilateral, Pheochromocytoma Benign 1 (50%)
Islets, Pancreatic (60) (60)
Carcinoma 1 (2%)
Pituitary Gland (60) (60)
Pars Distalis, Adenoma 28 (47%) 28 (47%)
Pars Distalis, Adenoma, Multiple 1 (2%)
Pars Distalis, Carcinoma 2 (3%) 2 (3%)
Thyroid Gland (60) (60)
Bilateral, C-Cell, Adenoma 1 (2%)
C-Cell, Adenoma 10 (17%) 5 (8%)
C-Cell, Carcinoma 1 (2%)
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Page 2
NTP Experiment-Test: 05102-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC BENZETHONIUM CHLORIDE Date: 05/19/95
Route: DERMAL,SOLUTION Time: 18:13:29
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0MG/KG .15MG/KG 0.5MG/KG 1.5MG/KG
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
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GENITAL SYSTEM
Clitoral Gland (59) (59)
Adenoma 4 (7%) 4 (7%)
Carcinoma 2 (3%)
Ovary (60) (60)
Uterus (60) (60)
Polyp Stromal 3 (5%) 7 (12%)
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HEMATOPOIETIC SYSTEM
Bone Marrow (60) (59)
Lymph Node (5) (1)
Lymph Node, Mandibular (7) (3)
Osteosarcoma, Metastatic, Bone 1 (33%)
Lymph Node, Mesenteric (5) (3)
Spleen (60) (60)
Thymus (54) (56)
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INTEGUMENTARY SYSTEM
Mammary Gland (60) (60)
Adenoma 2 (3%) 2 (3%)
Adenoma, Multiple 1 (2%)
Carcinoma 1 (2%)
Fibroadenoma 14 (23%) 12 (20%)
Fibroadenoma, Multiple 3 (5%) 5 (8%)
Fibroma 1 (2%)
Skin (60) (60) (60) (60)
Basosquamous Tumor Malignant 1 (2%)
Basosquamous Tumor Benign 1 (2%)
Trichoepithelioma 1 (2%)
Subcutaneous Tissue, Lipoma 1 (2%) 1 (2%)
Subcutaneous Tissue, Neurofibrosarcoma 1 (2%)
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Page 3
NTP Experiment-Test: 05102-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC BENZETHONIUM CHLORIDE Date: 05/19/95
Route: DERMAL,SOLUTION Time: 18:13:29
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0MG/KG .15MG/KG 0.5MG/KG 1.5MG/KG
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (60) (60)
Mandible, Osteosarcoma 1 (2%)
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NERVOUS SYSTEM
Brain (60) (60)
Carcinoma, Metastatic, Pituitary Gland 2 (3%) 2 (3%)
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RESPIRATORY SYSTEM
Lung (60) (60)
Carcinoma, Metastatic, Thyroid Gland 1 (2%)
Nose (60) (60)
Nares, Squamous Cell Papilloma 1 (2%)
Vomeronasal Organ, Squamous Cell Carcinoma 1 (2%)
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SPECIAL SENSES SYSTEM
None
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URINARY SYSTEM
Kidney (60) (60)
Urinary Bladder (60) (60)
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SYSTEMIC LESIONS
Multiple Organs *(60) *(60) *(60) *(60)
Leukemia Mononuclear 18 (30%) 18 (30%)
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* Number of animals with any tissue examined microscopically
Page 4
NTP Experiment-Test: 05102-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC BENZETHONIUM CHLORIDE Date: 05/19/95
Route: DERMAL,SOLUTION Time: 18:13:29
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0MG/KG .15MG/KG 0.5MG/KG 1.5MG/KG
____________________________________________________________________________________________________________________________________
TUMOR SUMMARY
Total Animals with Primary Neoplasms (b) 46 2 50
Total Primary Neoplasms 96 2 93
Total Animals with Benign Neoplasms 41 1 42
Total Benign Neoplasms 73 1 67
Total Animals with Malignant Neoplasms 23 1 21
Total Malignant Neoplasms 23 1 26
Total Animals with Metastatic Neoplasms 3 3
Total Metastatic Neoplasm 3 3
Total Animals with Malignant Neoplasms
Uncertain Primary Site
Total Animals with Neoplasms Uncertain-
Benign or Malignant
Total Uncertain Neoplasms
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a Number of animals examined microscopically at site and number of animals with lesion
b Primary tumors: all tumors except metastatic tumors
Page 5
NTP Experiment-Test: 05102-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC BENZETHONIUM CHLORIDE Date: 05/19/95
Route: DERMAL,SOLUTION Time: 18:13:29
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0MG/KG .15MG/KG 0.5MG/KG 1.5MG/KG
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially in Study 60 60 60 60
Scheduled Sacrifice 8 8 5 4
Early Deaths
Natural Death 12 7 11 15
Moribund Sacrifice 25 34 34 25
Accidently Killed 1
Survivors
Natural Death 1
Terminal Sacrifice 15 11 8 16
Animals Examined Microscopically 60 60 60 60
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ALIMENTARY SYSTEM
Intestine Large, Colon (1)
Adenoma 1 (100%)
Intestine Large, Cecum (1)
Intestine Small, Duodenum (3)
Intestine Small, Jejunum (2) (1)
Adenocarcinoma 1 (100%)
Adenoma 1 (50%)
Liver (60) (60)
Histiocytic Sarcoma 1 (2%)
Mesentery (8) (8)
Lipoma 1 (13%)
Fat, Histiocytic Sarcoma 1 (13%)
Pancreas (60) (60)
Pharynx (1)
Palate, Squamous Cell Papilloma 1 (100%)
Salivary Glands (60) (60)
Sarcoma 1 (2%)
Stomach, Forestomach (10) (13)
Squamous Cell Papilloma 1 (10%)
Tooth (2)
Gingiva, Squamous Cell Carcinoma 1 (50%)
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CARDIOVASCULAR SYSTEM
Heart (59) (60)
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Page 6
NTP Experiment-Test: 05102-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC BENZETHONIUM CHLORIDE Date: 05/19/95
Route: DERMAL,SOLUTION Time: 18:13:29
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0MG/KG .15MG/KG 0.5MG/KG 1.5MG/KG
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (29) (24)
Adenoma 1 (3%)
Squamous Cell Carcinoma, Metastatic, Lung 1 (4%)
Adrenal Medulla (27) (29)
Pheochromocytoma Malignant 1 (3%)
Pheochromocytoma Benign 3 (11%) 4 (14%)
Bilateral, Pheochromocytoma Benign 2 (7%) 3 (10%)
Islets, Pancreatic (60) (60)
Adenoma 1 (2%) 3 (5%)
Parathyroid Gland (58) (58)
Adenoma 1 (2%)
Pituitary Gland (60) (60)
Pars Distalis, Adenoma 34 (57%) 25 (42%)
Pars Intermedia, Adenoma 1 (2%)
Thyroid Gland (59) (60)
C-Cell, Adenoma 6 (10%) 9 (15%)
C-Cell, Adenoma, Multiple 1 (2%)
Follicular Cell, Adenoma 1 (2%) 2 (3%)
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GENERAL BODY SYSTEM
None
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GENITAL SYSTEM
Epididymis (60) (60)
Preputial Gland (60) (60)
Adenoma 1 (2%)
Carcinoma 1 (2%)
Bilateral, Carcinoma 1 (2%)
Prostate (60) (60)
Seminal Vesicle (60) (60)
Testes (60) (60)
Bilateral, Interstitial Cell, Adenoma 24 (40%) 30 (50%)
Interstitial Cell, Adenoma 21 (35%) 10 (17%)
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HEMATOPOIETIC SYSTEM
Bone Marrow (59) (60)
Femoral, Histiocytic Sarcoma 1 (2%)
Lymph Node (8) (14)
Mediastinal, Histiocytic Sarcoma 1 (13%)
Renal, Histiocytic Sarcoma 1 (13%)
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NTP Experiment-Test: 05102-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC BENZETHONIUM CHLORIDE Date: 05/19/95
Route: DERMAL,SOLUTION Time: 18:13:29
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0MG/KG .15MG/KG 0.5MG/KG 1.5MG/KG
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - cont
Thoracic, Squamous Cell Carcinoma,
Metastatic, Lung 1 (7%)
Lymph Node, Mandibular (13) (17)
Hemangiosarcoma 1 (8%)
Lymph Node, Mesenteric (9) (14)
Spleen (60) (60)
Hemangiosarcoma 1 (2%)
Histiocytic Sarcoma 2 (3%) 1 (2%)
Thymus (52) (51)
Squamous Cell Carcinoma, Metastatic, Lung 1 (2%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (55) (53)
Adenoma 1 (2%)
Fibroadenoma 1 (2%) 3 (6%)
Fibroma 3 (5%) 1 (2%)
Histiocytic Sarcoma 1 (2%)
Skin (60) (60) (60) (60)
Basal Cell Adenoma 1 (2%)
Basosquamous Tumor Benign 1 (2%)
Histiocytic Sarcoma 1 (2%)
Keratoacanthoma 1 (2%) 3 (5%)
Squamous Cell Papilloma 1 (2%) 1 (2%)
Sebaceous Gland, Lip, Carcinoma 1 (2%)
Subcutaneous Tissue, Fibroma 1 (2%) 1 (2%)
Subcutaneous Tissue, Fibrosarcoma 1 (2%)
Subcutaneous Tissue, Fibrous Histiocytoma 1 (2%)
Subcutaneous Tissue, Histiocytic Sarcoma 1 (2%)
Subcutaneous Tissue, Neurofibroma 1 (2%)
Skin, Site of Application-Mass (5) (3) (4)
Keratoacanthoma 1 (33%) 1 (25%)
Sebaceous Gland, Carcinoma 1 (33%)
Skin, Site of Application-No Mass (2) (1) (8) (16)
Subcutaneous Tissue, Histiocytic Sarcoma 1 (50%)
Skin, Site of Application-Mass (5) (3) (4)
Subcutaneous Tissue, Histiocytic Sarcoma 1 (20%)
Skin, Site of Application-No Mass (2) (1) (8) (16)
Subcutaneous Tissue, Histiocytic Sarcoma 1 (100%)
Skin, Site of Application-Mass (5) (3) (4)
Subcutaneous Tissue, Histiocytic Sarcoma 1 (33%)
Skin, Site of Application-No Mass (2) (1) (8) (16)
Subcutaneous Tissue, Histiocytic Sarcoma 1 (6%)
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Page 8
NTP Experiment-Test: 05102-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC BENZETHONIUM CHLORIDE Date: 05/19/95
Route: DERMAL,SOLUTION Time: 18:13:29
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0MG/KG .15MG/KG 0.5MG/KG 1.5MG/KG
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (59) (60)
Maxilla, Osteosarcoma 1 (2%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (60) (60)
Astrocytoma NOS 1 (2%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (59) (60)
Histiocytic Sarcoma 1 (2%)
Squamous Cell Carcinoma 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Ear (3)
Squamous Cell Papilloma 3 (100%)
Zymbal's Gland (2)
Carcinoma 2 (100%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (60) (60)
Transitional Epithelium, Carcinoma 1 (2%)
Urinary Bladder (60) (60)
Transitional Epithelium, Papilloma 1 (2%)
____________________________________________________________________________________________________________________________________
SYSTEMIC LESIONS
Multiple Organs *(60) *(60) *(60) *(60)
Histiocytic Sarcoma 3 (5%) 1 (2%) 1 (2%) 3 (5%)
Leukemia Mononuclear 23 (38%) 30 (50%)
Mesothelioma Benign 1 (2%)
Mesothelioma Malignant 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
* Number of animals with any tissue examined microscopically
Page 9
NTP Experiment-Test: 05102-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC BENZETHONIUM CHLORIDE Date: 05/19/95
Route: DERMAL,SOLUTION Time: 18:13:29
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0MG/KG .15MG/KG 0.5MG/KG 1.5MG/KG
____________________________________________________________________________________________________________________________________
TUMOR SUMMARY
Total Animals with Primary Neoplasms (b) 57 3 8 57
Total Primary Neoplasms 149 3 9 135
Total Animals with Benign Neoplasms 55 7 54
Total Benign Neoplasms 111 7 97
Total Animals with Malignant Neoplasms 30 3 2 33
Total Malignant Neoplasms 38 3 2 37
Total Animals with Metastatic Neoplasms 1
Total Metastatic Neoplasm 3
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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