TDMS Study 05162-09 Pathology Tables
NTP Experiment-Test: 05162-09 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC DIETHANOLAMINE Date: 04/08/96
Route: SKIN APPLICATION Time: 09:58:44
CORE STUDY
Facility: Battelle Columbus Laboratory
Chemical CAS #: 111-42-2
Lock Date: 05/07/93
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: 05162-09 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC DIETHANOLAMINE Date: 04/08/96
Route: SKIN APPLICATION Time: 09:58:44
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 MG/KG 8 MG/KG 16 MG/KG 32 MG/KG
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially in Study 50 50 50 50
Early Deaths
Natural Death 14 5 9 13
Moribund Sacrifice 11 16 12 13
Survivors
Terminal Sacrifice 25 29 29 24
Animals Examined Microscopically 50 50 50 50
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ALIMENTARY SYSTEM
Intestine Large, Colon (50) (50) (50) (49)
Intestine Large, Cecum (50) (49) (50) (49)
Intestine Small, Duodenum (50) (50) (50) (49)
Intestine Small, Jejunum (48) (49) (49) (46)
Intestine Small, Ileum (49) (49) (48) (47)
Liver (50) (50) (50) (50)
Hepatocellular Carcinoma 1 (2%)
Hepatocellular Adenoma 1 (2%) 1 (2%)
Mesentery (4) (7) (6) (5)
Yolk Sac Carcinoma, Metastatic, Ovary 1 (20%)
Oral Mucosa (2) (2) (1)
Squamous Cell Carcinoma 1 (50%) 1 (100%)
Pancreas (50) (50) (50) (50)
Salivary Glands (50) (50) (50) (50)
Stomach, Glandular (50) (50) (50) (50)
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CARDIOVASCULAR SYSTEM
Heart (50) (50) (50) (50)
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ENDOCRINE SYSTEM
Adrenal Cortex (50) (50) (50) (50)
Adenoma 1 (2%) 1 (2%)
Osteosarcoma, Metastatic, Bone 1 (2%)
Adrenal Medulla (49) (50) (49) (50)
Osteosarcoma, Metastatic, Bone 1 (2%)
Pheochromocytoma Benign 1 (2%) 2 (4%) 2 (4%)
Islets, Pancreatic (50) (50) (50) (50)
Adenoma 1 (2%) 1 (2%)
Carcinoma 1 (2%)
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NTP Experiment-Test: 05162-09 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC DIETHANOLAMINE Date: 04/08/96
Route: SKIN APPLICATION Time: 09:58:44
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 MG/KG 8 MG/KG 16 MG/KG 32 MG/KG
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM - cont
Pituitary Gland (49) (50) (50) (50)
Pars Distalis, Adenoma 25 (51%) 27 (54%) 30 (60%) 33 (66%)
Pars Distalis, Adenoma, Multiple 2 (4%) 4 (8%) 1 (2%) 1 (2%)
Pars Distalis, Carcinoma 2 (4%)
Thyroid Gland (50) (50) (50) (50)
Bilateral, C-Cell, Adenoma 1 (2%)
C-Cell, Adenoma 8 (16%) 8 (16%) 6 (12%) 5 (10%)
C-Cell, Carcinoma 1 (2%) 2 (4%)
Follicular Cell, Carcinoma 1 (2%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
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GENITAL SYSTEM
Clitoral Gland (50) (50) (49) (47)
Adenoma 4 (8%) 5 (10%) 2 (4%)
Adenoma, Multiple 1 (2%)
Ovary (50) (50) (50) (50)
Osteosarcoma, Metastatic, Bone 1 (2%)
Yolk Sac Carcinoma 1 (2%)
Uterus (50) (50) (50) (50)
Polyp Stromal 3 (6%) 1 (2%) 1 (2%) 2 (4%)
Sarcoma Stromal 1 (2%) 1 (2%) 1 (2%)
Yolk Sac Carcinoma, Metastatic, Ovary 1 (2%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (50) (50) (50) (50)
Lymph Node (1) (3) (3) (3)
Inguinal, Yolk Sac Carcinoma, Metastatic,
Ovary 1 (33%)
Mediastinal, Yolk Sac Carcinoma, Metastatic,
Ovary 1 (33%)
Lymph Node, Mandibular (50) (49) (50) (48)
Lymph Node, Mesenteric (50) (50) (50) (49)
Spleen (50) (50) (50) (50)
Hemangiosarcoma 1 (2%)
Thymus (49) (49) (47) (48)
Thymoma Benign 1 (2%)
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NTP Experiment-Test: 05162-09 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC DIETHANOLAMINE Date: 04/08/96
Route: SKIN APPLICATION Time: 09:58:44
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 MG/KG 8 MG/KG 16 MG/KG 32 MG/KG
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (50) (50) (49) (50)
Adenoma 1 (2%)
Carcinoma 1 (2%)
Carcinoma, Multiple 1 (2%)
Fibroadenoma 13 (26%) 6 (12%) 9 (18%) 4 (8%)
Fibroadenoma, Multiple 1 (2%) 2 (4%) 1 (2%)
Skin (50) (50) (50) (50)
Fibrosarcoma 1 (2%)
Schwannoma Malignant 1 (2%)
Squamous Cell Papilloma 1 (2%)
Trichoepithelioma 1 (2%)
Conjunctiva, Schwannoma Malignant 1 (2%)
Skin, Site of Application, Keratoacanthoma 1 (2%)
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MUSCULOSKELETAL SYSTEM
Bone (50) (50) (50) (50)
Carcinoma, Metastatic, Thyroid Gland 1 (2%)
Osteosarcoma 1 (2%)
Skeletal Muscle (1)
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NERVOUS SYSTEM
Brain (50) (49) (50) (50)
Astrocytoma Malignant 1 (2%)
Carcinoma, Metastatic, Pituitary Gland 1 (2%)
Medulla, Carcinoma, Metastatic, Pituitary
Gland 1 (2%)
Spinal Cord (1)
Glioma Malignant 1 (100%)
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RESPIRATORY SYSTEM
Lung (50) (50) (50) (50)
Alveolar/Bronchiolar Adenoma 2 (4%)
Alveolar/Bronchiolar Carcinoma 1 (2%)
Carcinoma, Metastatic, Thyroid Gland 1 (2%)
Osteosarcoma, Metastatic, Bone 1 (2%)
Squamous Cell Carcinoma, Metastatic, Oral
Mucosa 1 (2%)
Yolk Sac Carcinoma, Metastatic, Ovary 1 (2%)
____________________________________________________________________________________________________________________________________
Page 4
NTP Experiment-Test: 05162-09 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC DIETHANOLAMINE Date: 04/08/96
Route: SKIN APPLICATION Time: 09:58:44
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 MG/KG 8 MG/KG 16 MG/KG 32 MG/KG
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Zymbal's Gland (2) (1)
Carcinoma 2 (100%) 1 (100%)
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URINARY SYSTEM
Kidney (50) (50) (50) (50)
Osteosarcoma, Metastatic, Bone 1 (2%)
Urinary Bladder (50) (50) (49) (50)
Papilloma 1 (2%)
____________________________________________________________________________________________________________________________________
SYSTEMIC LESIONS
Multiple Organs *(50) *(50) *(50) *(50)
Leukemia Mononuclear 11 (22%) 13 (26%) 10 (20%) 13 (26%)
Lymphoma Malignant 1 (2%)
____________________________________________________________________________________________________________________________________
* Number of animals with any tissue examined microscopically
Page 5
NTP Experiment-Test: 05162-09 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC DIETHANOLAMINE Date: 04/08/96
Route: SKIN APPLICATION Time: 09:58:44
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 MG/KG 8 MG/KG 16 MG/KG 32 MG/KG
____________________________________________________________________________________________________________________________________
TUMOR SUMMARY
Total Animals with Primary Neoplasms (b) 46 42 43 45
Total Primary Neoplasms 78 81 68 73
Total Animals with Benign Neoplasms 38 39 40 41
Total Benign Neoplasms 59 63 53 50
Total Animals with Malignant Neoplasms 17 16 15 22
Total Malignant Neoplasms 19 18 15 23
Total Animals with Metastatic Neoplasms 2 4
Total Metastatic Neoplasm 2 13
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: 05162-09 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC DIETHANOLAMINE Date: 04/08/96
Route: SKIN APPLICATION Time: 09:58:44
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 MG/KG 16 MG/KG 32 MG/KG 64 MG/KG
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially in Study 50 50 50 50
Early Deaths
Moribund Sacrifice 31 31 25 22
Natural Death 5 9 4 6
Survivors
Terminal Sacrifice 14 10 21 22
Animals Examined Microscopically 50 50 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Intestine Large, Rectum (50) (50) (50) (49)
Carcinoma 1 (2%)
Intestine Small, Jejunum (50) (46) (48) (48)
Histiocytic Sarcoma 1 (2%)
Liver (50) (50) (50) (50)
Hepatocellular Adenoma 2 (4%) 1 (2%)
Histiocytic Sarcoma 1 (2%)
Mesentery (7) (4) (8) (3)
Histiocytic Sarcoma 1 (13%)
Oral Mucosa (7) (2) (2)
Squamous Cell Carcinoma 1 (14%) 1 (50%)
Squamous Cell Papilloma 1 (50%)
Pancreas (50) (50) (50) (50)
Adenoma 1 (2%)
Salivary Glands (50) (49) (50) (50)
Adenoma 1 (2%)
Schwannoma Malignant 1 (2%)
Stomach, Forestomach (50) (50) (50) (50)
Stomach, Glandular (50) (50) (50) (50)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (50) (50) (50) (50)
Pheochromocytoma Malignant, Metastatic,
Adrenal Medulla 1 (2%)
Yolk Sac Carcinoma, Metastatic, Tissue NOS 1 (2%)
____________________________________________________________________________________________________________________________________
Page 7
NTP Experiment-Test: 05162-09 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC DIETHANOLAMINE Date: 04/08/96
Route: SKIN APPLICATION Time: 09:58:44
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 MG/KG 16 MG/KG 32 MG/KG 64 MG/KG
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (50) (50) (50) (50)
Adenoma 2 (4%)
Adrenal Medulla (50) (50) (50) (50)
Pheochromocytoma Malignant 1 (2%)
Pheochromocytoma Benign 8 (16%) 7 (14%) 4 (8%) 12 (24%)
Bilateral, Pheochromocytoma Benign 1 (2%) 3 (6%)
Islets, Pancreatic (50) (50) (50) (50)
Adenoma 3 (6%) 1 (2%) 1 (2%) 2 (4%)
Carcinoma 2 (4%) 1 (2%) 1 (2%)
Parathyroid Gland (46) (49) (48) (47)
Adenoma 1 (2%)
Pituitary Gland (50) (50) (50) (49)
Astrocytoma Malignant, Metastatic, Brain 1 (2%)
Pars Distalis, Adenoma 32 (64%) 39 (78%) 37 (74%) 27 (55%)
Pars Distalis, Adenoma, Multiple 2 (4%) 5 (10%)
Pars Distalis, Carcinoma 1 (2%)
Thyroid Gland (50) (50) (50) (49)
Adenoma 1 (2%)
Carcinoma 1 (2%)
Bilateral, C-Cell, Adenoma 1 (2%)
C-Cell, Adenoma 6 (12%) 2 (4%) 5 (10%) 6 (12%)
C-Cell, Carcinoma 1 (2%)
Follicular Cell, Adenoma 1 (2%)
Follicular Cell, Carcinoma 1 (2%) 2 (4%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
Tissue NOS (1)
Yolk Sac Carcinoma 1 (100%)
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GENITAL SYSTEM
Epididymis (50) (50) (50) (50)
Histiocytic Sarcoma 1 (2%)
Preputial Gland (50) (50) (49) (50)
Adenoma 1 (2%) 1 (2%) 1 (2%) 4 (8%)
Prostate (50) (50) (50) (50)
Seminal Vesicle (50) (50) (50) (50)
Histiocytic Sarcoma 1 (2%)
Testes (50) (50) (50) (50)
Bilateral, Interstitial Cell, Adenoma 12 (24%) 9 (18%) 13 (26%) 10 (20%)
Interstitial Cell, Adenoma 20 (40%) 10 (20%) 15 (30%) 16 (32%)
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NTP Experiment-Test: 05162-09 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC DIETHANOLAMINE Date: 04/08/96
Route: SKIN APPLICATION Time: 09:58:44
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 MG/KG 16 MG/KG 32 MG/KG 64 MG/KG
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (50) (50) (50) (50)
Histiocytic Sarcoma 1 (2%)
Lymph Node (4) (4) (5) (2)
Deep Cervical, Bronchial, Mediastinal,
Leukemia Mononuclear 1 (25%)
Deep Cervical, Mediastinal, Carcinoma,
Metastatic, Thyroid Gland 1 (20%)
Mediastinal, Histiocytic Sarcoma 1 (20%)
Thoracic, Schwannoma Malignant 1 (50%)
Lymph Node, Mandibular (49) (48) (50) (49)
Lymph Node, Mesenteric (50) (50) (50) (50)
Spleen (50) (50) (50) (50)
Fibrosarcoma 1 (2%)
Thymus (47) (48) (48) (47)
Histiocytic Sarcoma 1 (2%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (46) (48) (45) (42)
Adenoma 1 (2%)
Carcinoma 1 (2%)
Fibroadenoma 1 (2%)
Skin (50) (50) (50) (50)
Keratoacanthoma 2 (4%) 1 (2%)
Schwannoma Malignant 1 (2%) 1 (2%)
Squamous Cell Carcinoma 1 (2%)
Squamous Cell Papilloma 1 (2%) 1 (2%)
Sebaceous Gland, Adenoma 2 (4%)
Sebaceous Gland, Skin, Site of Application,
Adenoma 1 (2%)
Skin, Site of Application, Keratoacanthoma 1 (2%)
Subcutaneous Tissue, Fibroma 1 (2%) 1 (2%)
Subcutaneous Tissue, Fibrosarcoma 1 (2%)
Subcutaneous Tissue, Schwannoma Malignant 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (50) (50) (50) (50)
Osteosarcoma 2 (4%) 1 (2%)
Skeletal Muscle (1)
Histiocytic Sarcoma 1 (100%)
____________________________________________________________________________________________________________________________________
Page 9
NTP Experiment-Test: 05162-09 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC DIETHANOLAMINE Date: 04/08/96
Route: SKIN APPLICATION Time: 09:58:44
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 MG/KG 16 MG/KG 32 MG/KG 64 MG/KG
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (50) (50) (50)
Astrocytoma Malignant 1 (2%)
Spinal Cord (2) (1) (1)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (50) (50) (50)
Alveolar/Bronchiolar Adenoma 1 (2%)
Alveolar/Bronchiolar Carcinoma 1 (2%)
Histiocytic Sarcoma 1 (2%)
Histiocytic Sarcoma, Metastatic, Pituitary
Gland 1 (2%)
Osteosarcoma, Metastatic, Bone 1 (2%) 1 (2%)
Pheochromocytoma Malignant, Metastatic,
Adrenal Medulla 1 (2%)
Yolk Sac Carcinoma, Metastatic, Tissue NOS 1 (2%)
Nose (50) (50) (50) (49)
Chondroma 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Harderian Gland (3)
Squamous Cell Carcinoma, Metastatic, Oral
Mucosa 1 (33%)
Zymbal's Gland (3) (1) (2)
Carcinoma 2 (67%) 1 (100%) 1 (50%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (50) (50) (50)
Nephroblastoma 1 (2%)
Renal Tubule, Carcinoma 1 (2%)
Urinary Bladder (48) (50) (50) (50)
____________________________________________________________________________________________________________________________________
SYSTEMIC LESIONS
Multiple Organs *(50) *(50) *(50) *(50)
Histiocytic Sarcoma 1 (2%) 1 (2%)
Leukemia Mononuclear 23 (46%) 14 (28%) 13 (26%) 18 (36%)
Lymphoma Malignant 1 (2%)
Mesothelioma Malignant 2 (4%) 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
* Number of animals with any tissue examined microscopically
Page 10
NTP Experiment-Test: 05162-09 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC DIETHANOLAMINE Date: 04/08/96
Route: SKIN APPLICATION Time: 09:58:44
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 MG/KG 16 MG/KG 32 MG/KG 64 MG/KG
____________________________________________________________________________________________________________________________________
TUMOR SUMMARY
Total Animals with Primary Neoplasms (b) 50 49 49 47
Total Primary Neoplasms 126 107 107 112
Total Animals with Benign Neoplasms 47 46 48 45
Total Benign Neoplasms 90 78 86 88
Total Animals with Malignant Neoplasms 32 23 19 22
Total Malignant Neoplasms 36 29 21 24
Total Animals with Metastatic Neoplasms 5 3 1
Total Metastatic Neoplasm 7 3 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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