TDMS Study 88122-06 Pathology Tables
NTP Experiment-Test: 88122-06 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC ELMIRON Date: 06/12/01
Route: GAVAGE Time: 09:18:08
FINAL#1
Facility: Battelle Columbus Laboratory
Chemical CAS #: 37319-17-8
Lock Date: 06/01/00
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: 88122-06 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC ELMIRON Date: 06/12/01
Route: GAVAGE Time: 09:18:08
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 MG/KG 28 MG/KG 84 MG/KG 252
MG/KG
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially in Study 50 50 50 50
Early Deaths
Natural Death 13 10 9 6
Moribund Sacrifice 6 8 11 11
Dosing Accident 1 2 5
Accidently Killed 1 1
Survivors
Natural Death 1
Terminal Sacrifice 30 31 28 26
Animals Examined Microscopically 50 50 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Intestine Large, Rectum (46) (43) (44) (42)
Leiomyosarcoma, Metastatic, Vagina 1 (2%)
Liver (50) (50) (50) (50)
Fibrous Histiocytoma 1 (2%)
Hepatocellular Carcinoma 1 (2%)
Leiomyosarcoma, Metastatic, Uterus 1 (2%)
Mesentery (8) (4) (6) (9)
Liposarcoma 1 (13%)
Pancreas (50) (50) (50) (50)
Adenoma 1 (2%)
Salivary Glands (50) (50) (50) (50)
Stomach, Forestomach (50) (50) (50) (50)
Stomach, Glandular (50) (50) (50) (50)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (50) (50) (50) (50)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (50) (50) (50) (50)
Adenoma 1 (2%)
Adrenal Medulla (50) (50) (50) (50)
Pheochromocytoma Benign 2 (4%) 1 (2%) 3 (6%)
Page 2
NTP Experiment-Test: 88122-06 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC ELMIRON Date: 06/12/01
Route: GAVAGE Time: 09:18:08
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 MG/KG 28 MG/KG 84 MG/KG 252
MG/KG
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM - cont
Bilateral, Pheochromocytoma Malignant 1 (2%)
Islets, Pancreatic (50) (50) (50) (50)
Adenoma 1 (2%) 2 (4%)
Parathyroid Gland (46) (44) (46) (45)
Adenoma 1 (2%)
Pituitary Gland (50) (50) (50) (50)
Pars Distalis, Adenoma 21 (42%) 21 (42%) 26 (52%) 19 (38%)
Pars Intermedia, Adenoma 1 (2%)
Thyroid Gland (50) (50) (50) (50)
Bilateral, C-Cell, Adenoma 1 (2%)
C-Cell, Adenoma 11 (22%) 7 (14%) 9 (18%) 9 (18%)
C-Cell, Adenoma, Multiple 1 (2%)
Follicle, Carcinoma 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Clitoral Gland (50) (50) (50) (49)
Adenoma 3 (6%) 4 (8%)
Ovary (50) (50) (50) (50)
Granulosa Cell Tumor Malignant 1 (2%)
Uterus (50) (50) (50) (50)
Adenocarcinoma 1 (2%)
Leiomyoma 1 (2%)
Leiomyosarcoma 1 (2%)
Polyp Stromal 7 (14%) 8 (16%) 7 (14%) 5 (10%)
Sarcoma Stromal 1 (2%)
Endometrium, Polyp Stromal 1 (2%)
Endometrium, Sarcoma Stromal 1 (2%)
Vagina (2) (2)
Leiomyosarcoma 1 (50%) 1 (50%)
____________________________________________________________________________________________________________________________________
Page 3
NTP Experiment-Test: 88122-06 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC ELMIRON Date: 06/12/01
Route: GAVAGE Time: 09:18:08
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 MG/KG 28 MG/KG 84 MG/KG 252
MG/KG
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (50) (50) (50) (50)
Lymph Node (7) (19) (14) (13)
Lymph Node, Mandibular (3) (8) (3) (2)
Lymph Node, Mesenteric (50) (50) (50) (49)
Spleen (50) (50) (50) (50)
Thymus (45) (41) (46) (41)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (50) (50) (50) (50)
Adenolipoma 1 (2%)
Adenoma 1 (2%) 1 (2%)
Carcinoma 1 (2%) 1 (2%) 1 (2%) 3 (6%)
Fibroadenoma 11 (22%) 21 (42%) 16 (32%) 17 (34%)
Fibroadenoma, Multiple 4 (8%) 2 (4%) 8 (16%) 4 (8%)
Skin (50) (50) (50) (50)
Basal Cell Adenoma 1 (2%)
Keratoacanthoma 1 (2%)
Subcutaneous Tissue, Fibroma 1 (2%) 2 (4%)
Subcutaneous Tissue, Fibrous Histiocytoma 1 (2%)
Subcutaneous Tissue, Lipoma 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Skeletal Muscle (1)
Leiomyosarcoma, Metastatic, Vagina 1 (100%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (50) (50) (50)
Astrocytoma Malignant 1 (2%)
Oligodendroglioma Malignant 1 (2%)
____________________________________________________________________________________________________________________________________
Page 4
NTP Experiment-Test: 88122-06 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC ELMIRON Date: 06/12/01
Route: GAVAGE Time: 09:18:08
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 MG/KG 28 MG/KG 84 MG/KG 252
MG/KG
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (50) (50) (50)
Alveolar/Bronchiolar Carcinoma 1 (2%)
Fibrous Histiocytoma 1 (2%)
Leiomyosarcoma, Metastatic, Uterus 1 (2%)
Pheochromocytoma Malignant, Metastatic,
Adrenal Medulla 1 (2%)
Nose (50) (50) (50) (50)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Zymbal's Gland (1)
Adenoma 1 (100%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (50) (50) (50)
____________________________________________________________________________________________________________________________________
SYSTEMIC LESIONS
Multiple Organs *(50) *(50) *(50) *(50)
Adenolipoma 1 (2%)
Leukemia Mononuclear 7 (14%) 14 (28%) 8 (16%) 10 (20%)
____________________________________________________________________________________________________________________________________
* Number of animals with any tissue examined microscopically
Page 5
NTP Experiment-Test: 88122-06 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC ELMIRON Date: 06/12/01
Route: GAVAGE Time: 09:18:08
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 MG/KG 28 MG/KG 84 MG/KG 252
MG/KG
____________________________________________________________________________________________________________________________________
TUMOR SUMMARY
Total Animals with Primary Neoplasms (b) 42 45 44 40
Total Primary Neoplasms 79 80 90 82
Total Animals with Benign Neoplasms 37 41 41 35
Total Benign Neoplasms 66 63 74 65
Total Animals with Malignant Neoplasms 12 17 14 15
Total Malignant Neoplasms 13 17 16 17
Total Animals with Metastatic Neoplasms 2 1
Total Metastatic Neoplasm 3 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
Page 6
NTP Experiment-Test: 88122-06 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC ELMIRON Date: 06/12/01
Route: GAVAGE Time: 09:18:08
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 MG/KG 14 MG/KG 42 MG/KG 126
MG/KG
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially in Study 50 50 50 50
Early Deaths
Natural Death 7 9 8 5
Moribund Sacrifice 15 10 17 12
Dosing Accident 2 2 5
Survivors
Terminal Sacrifice 26 29 25 28
Animals Examined Microscopically 50 50 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Intestine Large, Colon (50) (50) (50) (50)
Intestine Large, Rectum (48) (48) (49) (45)
Histiocytic Sarcoma 1 (2%)
Polyp Adenomatous 1 (2%) 1 (2%) 1 (2%)
Intestine Small, Duodenum (50) (50) (50) (50)
Liver (50) (50) (50) (50)
Histiocytic Sarcoma 1 (2%)
Mesentery (9) (11) (9) (13)
Schwannoma Malignant 1 (9%)
Pancreas (50) (50) (50) (50)
Acinus, Adenoma 1 (2%)
Acinus, Carcinoma 1 (2%)
Salivary Glands (50) (50) (49) (50)
Schwannoma Malignant 1 (2%) 2 (4%) 1 (2%) 1 (2%)
Stomach, Forestomach (50) (50) (50) (50)
Stomach, Glandular (50) (50) (50) (50)
Leiomyosarcoma 1 (2%)
Tongue (1)
Squamous Cell Papilloma 1 (100%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (50) (50) (50) (50)
Histiocytic Sarcoma 1 (2%)
____________________________________________________________________________________________________________________________________
Page 7
NTP Experiment-Test: 88122-06 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC ELMIRON Date: 06/12/01
Route: GAVAGE Time: 09:18:08
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 MG/KG 14 MG/KG 42 MG/KG 126
MG/KG
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (50) (50) (50) (50)
Adrenal Medulla (50) (50) (50) (50)
Pheochromocytoma Malignant 1 (2%) 3 (6%) 1 (2%)
Pheochromocytoma Benign 6 (12%) 6 (12%) 2 (4%) 8 (16%)
Bilateral, Pheochromocytoma Benign 1 (2%) 1 (2%) 1 (2%)
Islets, Pancreatic (50) (50) (50) (50)
Adenoma 1 (2%) 1 (2%) 1 (2%)
Carcinoma 1 (2%)
Pituitary Gland (50) (50) (50) (50)
Pars Distalis, Adenoma 19 (38%) 18 (36%) 18 (36%) 13 (26%)
Pars Distalis, Carcinoma 1 (2%)
Pars Intermedia, Adenoma 1 (2%)
Thyroid Gland (50) (50) (50) (50)
Schwannoma Malignant, Metastatic, Salivary
Glands 1 (2%)
Bilateral, C-Cell, Adenoma 1 (2%) 1 (2%)
Bilateral, C-Cell, Carcinoma 1 (2%)
Bilateral, Follicle, Carcinoma 1 (2%)
C-Cell, Adenoma 5 (10%) 7 (14%) 8 (16%) 6 (12%)
C-Cell, Adenoma, Multiple 2 (4%) 1 (2%)
C-Cell, Carcinoma 1 (2%) 1 (2%) 1 (2%)
Follicle, Adenoma 1 (2%) 1 (2%) 3 (6%)
Follicle, Carcinoma 2 (4%) 1 (2%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Epididymis (50) (50) (50) (50)
Preputial Gland (50) (50) (50) (50)
Adenoma 1 (2%) 1 (2%) 1 (2%) 2 (4%)
Carcinoma 1 (2%)
Prostate (50) (50) (50) (49)
Histiocytic Sarcoma 1 (2%)
Seminal Vesicle (50) (50) (50) (49)
Testes (50) (50) (50) (50)
Bilateral, Interstitial Cell, Adenoma 35 (70%) 37 (74%) 37 (74%) 35 (70%)
Interstitial Cell, Adenoma 9 (18%) 6 (12%) 6 (12%) 5 (10%)
Page 8
NTP Experiment-Test: 88122-06 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC ELMIRON Date: 06/12/01
Route: GAVAGE Time: 09:18:08
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 MG/KG 14 MG/KG 42 MG/KG 126
MG/KG
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM - cont
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (50) (50) (50) (50)
Lymph Node (11) (17) (10) (13)
Deep Cervical, Carcinoma, Metastatic,
Thyroid Gland 1 (9%) 1 (8%)
Mediastinal, Carcinoma, Metastatic, Thyroid
Gland 1 (9%)
Lymph Node, Mandibular (5) (5) (9) (2)
Lymph Node, Mesenteric (50) (50) (50) (49)
Spleen (50) (50) (50) (50)
Thymus (45) (44) (43) (43)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (49) (49) (50) (48)
Adenoma 1 (2%)
Fibroadenoma 2 (4%) 1 (2%) 3 (6%) 5 (10%)
Fibroma 1 (2%)
Skin (50) (50) (50) (50)
Basal Cell Adenoma 1 (2%)
Keratoacanthoma 2 (4%) 3 (6%) 3 (6%) 1 (2%)
Squamous Cell Carcinoma 1 (2%) 1 (2%)
Squamous Cell Papilloma 1 (2%)
Sebaceous Gland, Adenoma 1 (2%) 1 (2%) 1 (2%) 2 (4%)
Sebaceous Gland, Carcinoma 1 (2%) 1 (2%)
Subcutaneous Tissue, Fibroma 1 (2%) 1 (2%) 3 (6%) 1 (2%)
Subcutaneous Tissue, Fibrosarcoma 2 (4%) 2 (4%) 1 (2%) 1 (2%)
Subcutaneous Tissue, Hemangiosarcoma 1 (2%)
Subcutaneous Tissue, Lipoma 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (50) (50) (50) (50)
Osteosarcoma 1 (2%)
Vertebra, Chordoma 1 (2%)
Skeletal Muscle (1) (2)
Histiocytic Sarcoma 1 (100%)
____________________________________________________________________________________________________________________________________
Page 9
NTP Experiment-Test: 88122-06 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC ELMIRON Date: 06/12/01
Route: GAVAGE Time: 09:18:08
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 MG/KG 14 MG/KG 42 MG/KG 126
MG/KG
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (50) (50) (50)
Astrocytoma Malignant 1 (2%)
Carcinoma, Metastatic, Pituitary Gland 1 (2%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (50) (50) (50)
Alveolar/Bronchiolar Adenoma 1 (2%) 1 (2%) 2 (4%)
Alveolar/Bronchiolar Carcinoma 1 (2%) 1 (2%)
Alveolar/Bronchiolar Carcinoma, Multiple 1 (2%)
Carcinoma, Metastatic, Thyroid Gland 1 (2%) 1 (2%) 1 (2%)
Chordoma, Metastatic, Bone 1 (2%)
Histiocytic Sarcoma 1 (2%)
Pheochromocytoma Malignant, Metastatic,
Adrenal Medulla 1 (2%)
Schwannoma Malignant, Metastatic, Salivary
Glands 1 (2%)
Nose (50) (50) (50) (50)
Respiratory Epithelium, Adenoma 1 (2%)
Trachea (50) (50) (50) (50)
Schwannoma Malignant, Metastatic, Salivary
Glands 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
None
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (50) (50) (50)
Ureter (1)
Urinary Bladder (50) (50) (50) (49)
Page 10
NTP Experiment-Test: 88122-06 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC ELMIRON Date: 06/12/01
Route: GAVAGE Time: 09:18:08
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 MG/KG 14 MG/KG 42 MG/KG 126
MG/KG
____________________________________________________________________________________________________________________________________
SYSTEMIC LESIONS
Multiple Organs *(50) *(50) *(50) *(50)
Histiocytic Sarcoma 1 (2%)
Leukemia Mononuclear 15 (30%) 16 (32%) 12 (24%) 16 (32%)
Mesothelioma Malignant 2 (4%) 2 (4%) 4 (8%)
____________________________________________________________________________________________________________________________________
* Number of animals with any tissue examined microscopically
Page 11
NTP Experiment-Test: 88122-06 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC ELMIRON Date: 06/12/01
Route: GAVAGE Time: 09:18:08
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 MG/KG 14 MG/KG 42 MG/KG 126
MG/KG
____________________________________________________________________________________________________________________________________
TUMOR SUMMARY
Total Animals with Primary Neoplasms (b) 49 48 50 45
Total Primary Neoplasms 124 117 110 113
Total Animals with Benign Neoplasms 49 47 49 45
Total Benign Neoplasms 93 90 88 84
Total Animals with Malignant Neoplasms 29 25 22 25
Total Malignant Neoplasms 31 27 22 29
Total Animals with Metastatic Neoplasms 4 2 1 1
Total Metastatic Neoplasm 6 2 2 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
Page 12
------------------------------------------------------------
---------- END OF REPORT ----------
------------------------------------------------------------