TDMS Study 05161-05 Pathology Tables
NTP Experiment-Test: 05161-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC RIDDELLIINE Date: 12/15/00
Route: GAVAGE Time: 12:06:54
RATS/FINAL#1
Facility: Southern Research Institute
Chemical CAS #: 23246-96-0
Lock Date: 11/17/99
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
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NTP Experiment-Test: 05161-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC RIDDELLIINE Date: 12/15/00
Route: GAVAGE Time: 12:06:54
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 0.01 0.033 0.1 0.33 1.0
MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially in Study 50 50 50 50 50 50
Early Deaths
Natural Death 6 11 6 12 2 31
Dosing Accident 2 6 3 2 3
Moribund Sacrifice 9 11 13 14 16 19
Survivors
Terminal Sacrifice 33 22 28 22 29
Animals Examined Microscopically 50 50 50 50 50 50
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ALIMENTARY SYSTEM
Intestine Large, Colon (49) (50) (50) (47) (50) (50)
Lipoma 2 (4%)
Intestine Large, Rectum (49) (50) (49) (48) (48) (49)
Polyp Adenomatous 1 (2%)
Intestine Large, Cecum (50) (50) (48) (47) (50) (50)
Intestine Small, Jejunum (50) (43) (47) (43) (50) (49)
Polyp Adenomatous 1 (2%)
Liver (50) (50) (50) (50) (50) (50)
Cholangiocarcinoma 1 (2%)
Hemangiosarcoma 3 (6%) 25 (50%)
Hemangiosarcoma, Multiple 13 (26%)
Hepatocellular Carcinoma 1 (2%) 1 (2%)
Hepatocellular Adenoma 1 (2%) 7 (14%)
Hepatocellular Adenoma, Multiple 1 (2%)
Mesentery (10) (10) (18) (14) (13) (5)
Hemangiosarcoma, Metastatic, Liver 2 (40%)
Sarcoma Stromal, Metastatic, Uterus 1 (8%)
Oral Mucosa (2)
Squamous Cell Carcinoma 1 (50%)
Squamous Cell Papilloma 1 (50%)
Pancreas (50) (50) (50) (46) (50) (50)
Acinus, Adenoma 1 (2%)
Stomach, Forestomach (50) (50) (50) (49) (49) (50)
Stomach, Glandular (50) (50) (50) (49) (49) (50)
Tongue (2)
Squamous Cell Papilloma 2 (100%)
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NTP Experiment-Test: 05161-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC RIDDELLIINE Date: 12/15/00
Route: GAVAGE Time: 12:06:54
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 0.01 0.033 0.1 0.33 1.0
MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (50) (50) (50) (50) (50) (50)
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ENDOCRINE SYSTEM
Adrenal Cortex (50) (50) (50) (50) (50) (50)
Adenoma 1 (2%) 1 (2%) 1 (2%) 1 (2%)
Carcinoma 1 (2%)
Adrenal Medulla (50) (49) (50) (50) (50) (50)
Pheochromocytoma Malignant 1 (2%) 1 (2%)
Pheochromocytoma Benign 1 (2%) 5 (10%) 2 (4%) 1 (2%) 3 (6%) 1 (2%)
Islets, Pancreatic (50) (50) (50) (46) (50) (50)
Adenoma 2 (4%) 2 (4%) 4 (8%) 1 (2%)
Carcinoma 1 (2%)
Pituitary Gland (50) (48) (50) (49) (50) (49)
Pars Distalis, Adenoma 26 (52%) 21 (44%) 21 (42%) 17 (35%) 24 (48%) 7 (14%)
Pars Distalis, Adenoma, Multiple 1 (2%) 1 (2%)
Pars Intermedia, Adenoma 1 (2%) 1 (2%)
Thyroid Gland (49) (50) (49) (49) (50) (50)
Bilateral, C-Cell, Adenoma 1 (2%)
C-Cell, Adenoma 1 (2%) 4 (8%) 4 (8%) 6 (12%) 11 (22%)
C-Cell, Carcinoma 1 (2%)
Follicular Cell, Carcinoma 1 (2%) 1 (2%)
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GENERAL BODY SYSTEM
Peritoneum (1)
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GENITAL SYSTEM
Clitoral Gland (49) (49) (49) (48) (49) (50)
Adenoma 5 (10%) 6 (12%) 8 (16%) 9 (19%) 3 (6%) 2 (4%)
Carcinoma 3 (6%) 2 (4%) 4 (8%) 3 (6%) 2 (4%)
Bilateral, Adenoma 2 (4%) 1 (2%) 1 (2%) 1 (2%)
Ovary (50) (49) (50) (50) (50) (50)
Granulosa Cell Tumor Malignant 1 (2%) 1 (2%) 1 (2%)
Luteoma 1 (2%)
Uterus (50) (50) (50) (50) (50) (50)
Carcinoma 1 (2%)
Deciduoma Benign 1 (2%)
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NTP Experiment-Test: 05161-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC RIDDELLIINE Date: 12/15/00
Route: GAVAGE Time: 12:06:54
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 0.01 0.033 0.1 0.33 1.0
MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM - cont
Leiomyoma 1 (2%)
Leiomyosarcoma 1 (2%)
Polyp Stromal 9 (18%) 14 (28%) 15 (30%) 11 (22%) 9 (18%) 5 (10%)
Polyp Stromal, Multiple 2 (4%) 1 (2%)
Sarcoma Stromal 2 (4%) 4 (8%) 2 (4%)
Vagina (2) (3) (3) (4) (5)
Leiomyoma 1 (33%)
Sarcoma Stromal, Metastatic, Uterus 1 (25%)
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HEMATOPOIETIC SYSTEM
Bone Marrow (50) (50) (50) (50) (50) (50)
Lymph Node (26) (24) (36) (19) (21) (40)
Mediastinal, Hemangiosarcoma, Metastatic,
Liver 2 (5%)
Lymph Node, Mandibular (50) (49) (48) (50) (50) (50)
Lymph Node, Mesenteric (50) (50) (50) (47) (49) (49)
Spleen (50) (50) (50) (50) (50) (50)
Thymus (48) (48) (46) (48) (50) (49)
Thymoma Benign 1 (2%)
Thymoma Malignant 1 (2%)
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INTEGUMENTARY SYSTEM
Mammary Gland (50) (50) (50) (50) (49) (49)
Adenoma 1 (2%) 1 (2%) 1 (2%) 1 (2%) 1 (2%)
Carcinoma 2 (4%) 3 (6%) 2 (4%) 4 (8%) 1 (2%)
Fibroadenoma 16 (32%) 17 (34%) 22 (44%) 17 (34%) 18 (37%) 3 (6%)
Fibroadenoma, Multiple 12 (24%) 4 (8%) 4 (8%) 7 (14%) 5 (10%)
Skin (50) (50) (49) (50) (50) (50)
Basal Cell Adenoma 1 (2%) 1 (2%)
Basal Cell Carcinoma 1 (2%) 1 (2%)
Keratoacanthoma 1 (2%) 1 (2%)
Myxosarcoma 1 (2%)
Schwannoma Malignant 1 (2%)
Squamous Cell Papilloma 1 (2%)
Subcutaneous Tissue, Fibroma 1 (2%) 5 (10%) 3 (6%) 1 (2%)
Subcutaneous Tissue, Fibrosarcoma 1 (2%)
Subcutaneous Tissue, Lipoma 1 (2%)
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NTP Experiment-Test: 05161-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC RIDDELLIINE Date: 12/15/00
Route: GAVAGE Time: 12:06:54
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 0.01 0.033 0.1 0.33 1.0
MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Skeletal Muscle (1) (1) (2) (6)
Rhabdomyosarcoma 1 (100%)
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NERVOUS SYSTEM
Brain (50) (50) (50) (50) (50) (50)
Glioma Malignant 1 (2%)
Granular Cell Tumor Malignant 1 (2%)
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RESPIRATORY SYSTEM
Lung (50) (50) (50) (50) (50) (50)
Alveolar/Bronchiolar Adenoma 2 (4%) 3 (6%) 2 (4%)
Alveolar/Bronchiolar Carcinoma 1 (2%)
Hemangiosarcoma 1 (2%)
Hemangiosarcoma, Metastatic, Liver 1 (2%) 17 (34%)
Hepatocellular Carcinoma, Metastatic,
Uncertain Primary Site 1 (2%)
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SPECIAL SENSES SYSTEM
Zymbal's Gland (1)
Carcinoma 1 (100%)
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URINARY SYSTEM
Kidney (50) (50) (50) (50) (50) (50)
Urinary Bladder (50) (50) (50) (48) (50) (50)
Papilloma 1 (2%)
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SYSTEMIC LESIONS
Multiple Organs *(50) *(50) *(50) *(50) *(50) *(50)
Leukemia Mononuclear 12 (24%) 8 (16%) 13 (26%) 18 (36%) 18 (36%) 14 (28%)
Lymphoma Malignant 1 (2%) 1 (2%)
* Number of animals with any tissue examined microscopically
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NTP Experiment-Test: 05161-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC RIDDELLIINE Date: 12/15/00
Route: GAVAGE Time: 12:06:54
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 0.01 0.033 0.1 0.33 1.0
MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY
____________________________________________________________________________________________________________________________________
SYSTEMIC LESIONS - cont
Multiple Organs *(50) *(50) *(50) *(50) *(50) *(50)
Mesothelioma Malignant 1 (2%)
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NTP Experiment-Test: 05161-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC RIDDELLIINE Date: 12/15/00
Route: GAVAGE Time: 12:06:54
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 0.01 0.033 0.1 0.33 1.0
MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY
____________________________________________________________________________________________________________________________________
TUMOR SUMMARY
Total Animals with Primary Neoplasms (b) 47 47 48 47 50 50
Total Primary Neoplasms 115 102 119 109 113 84
Total Animals with Benign Neoplasms 45 42 45 41 45 22
Total Benign Neoplasms 90 84 92 80 80 27
Total Animals with Malignant Neoplasms 20 16 21 28 28 47
Total Malignant Neoplasms 25 18 27 29 33 57
Total Animals with Metastatic Neoplasms 1 2 2 17
Total Metastatic Neoplasm 1 3 2 21
Total Animals with Malignant Neoplasms 1
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
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NTP Experiment-Test: 05161-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC RIDDELLIINE Date: 12/15/00
Route: GAVAGE Time: 12:06:54
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 1.0
MG/KG/DY MG/KG/DY
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially in Study 50 50
Early Deaths
Moribund Sacrifice 1 9
Natural Death 36
Dosing Accident 2
Survivors
Terminal Sacrifice 49 3
Animals Examined Microscopically 50 50
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ALIMENTARY SYSTEM
Liver (50) (50)
Hemangiosarcoma 19 (38%)
Hemangiosarcoma, Multiple 24 (48%)
Hepatocellular Adenoma 3 (6%)
Hepatocellular Adenoma, Multiple 1 (2%)
Hepatocholangiocarcinoma 1 (2%)
Mesentery (8) (9)
Chordoma, Metastatic, Mesentery 1 (11%)
Hemangiosarcoma, Metastatic, Liver 4 (44%)
Pancreas (50) (50)
Hemangiosarcoma, Metastatic, Liver 2 (4%)
Acinus, Adenoma 1 (2%) 1 (2%)
Salivary Glands (50) (50)
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CARDIOVASCULAR SYSTEM
Heart (50) (50)
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ENDOCRINE SYSTEM
Adrenal Cortex (49) (50)
Adrenal Medulla (49) (50)
Pheochromocytoma Benign 2 (4%) 2 (4%)
Pituitary Gland (50) (49)
Pars Distalis, Adenoma 11 (22%) 2 (4%)
Pars Distalis, Carcinoma 1 (2%)
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NTP Experiment-Test: 05161-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC RIDDELLIINE Date: 12/15/00
Route: GAVAGE Time: 12:06:54
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 1.0
MG/KG/DY MG/KG/DY
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM - cont
Thyroid Gland (50) (50)
C-Cell, Adenoma 3 (6%) 3 (6%)
C-Cell, Carcinoma 1 (2%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
Peritoneum (4) (3)
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GENITAL SYSTEM
Epididymis (50) (50)
Preputial Gland (50) (50)
Adenoma 2 (4%)
Carcinoma 1 (2%)
Seminal Vesicle (50) (50)
Testes (50) (50)
Bilateral, Interstitial Cell, Adenoma 18 (36%)
Interstitial Cell, Adenoma 21 (42%) 7 (14%)
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HEMATOPOIETIC SYSTEM
Bone Marrow (50) (49)
Lymph Node (13) (39)
Mediastinal, Hemangiosarcoma, Metastatic,
Liver 3 (8%)
Lymph Node, Mandibular (50) (50)
Lymph Node, Mesenteric (50) (50)
Spleen (50) (49)
Hemangiosarcoma, Metastatic, Liver 1 (2%)
Thymus (49) (49)
Thymoma Benign 1 (2%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Skin (50) (50)
Keratoacanthoma 2 (4%) 1 (2%)
Squamous Cell Papilloma 1 (2%)
Subcutaneous Tissue, Fibroma 2 (4%)
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NTP Experiment-Test: 05161-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC RIDDELLIINE Date: 12/15/00
Route: GAVAGE Time: 12:06:54
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 1.0
MG/KG/DY MG/KG/DY
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (50) (50)
Osteosarcoma 1 (2%)
Skeletal Muscle (1) (5)
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NERVOUS SYSTEM
Brain (50) (50)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (50)
Alveolar/Bronchiolar Adenoma 3 (6%)
Alveolar/Bronchiolar Carcinoma 1 (2%)
Chordoma, Metastatic, Mesentery 1 (2%)
Hemangiosarcoma, Metastatic, Liver 26 (52%)
Hepatocholangiocarcinoma, Metastatic, Liver 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Ear (1) (1)
Neural Crest Tumor 1 (100%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (50)
Urinary Bladder (50) (50)
____________________________________________________________________________________________________________________________________
SYSTEMIC LESIONS
Multiple Organs *(50) *(50)
Leukemia Mononuclear 2 (4%) 9 (18%)
Lymphoma Malignant 2 (4%)
Mesothelioma Malignant 4 (8%) 3 (6%)
____________________________________________________________________________________________________________________________________
* Number of animals with any tissue examined microscopically
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NTP Experiment-Test: 05161-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC RIDDELLIINE Date: 12/15/00
Route: GAVAGE Time: 12:06:54
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 1.0
MG/KG/DY MG/KG/DY
____________________________________________________________________________________________________________________________________
TUMOR SUMMARY
Total Animals with Primary Neoplasms (b) 47 49
Total Primary Neoplasms 73 85
Total Animals with Benign Neoplasms 47 15
Total Benign Neoplasms 64 23
Total Animals with Malignant Neoplasms 9 47
Total Malignant Neoplasms 9 60
Total Animals with Metastatic Neoplasms 1 30
Total Metastatic Neoplasm 4 39
Total Animals with Malignant Neoplasms
Uncertain Primary Site
Total Animals with Neoplasms Uncertain-
Benign or Malignant 1
Total Uncertain Neoplasms 2
____________________________________________________________________________________________________________________________________
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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