TDMS Study 92013-05 Pathology Tables
NTP Experiment-Test: 92013-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC 4-METHYLIMIDAZOLE Date: 12/06/04
Route: DOSED FEED Time: 08:36:54
FINAL #1 RATS
Facility: Southern Research Institute
Chemical CAS #: 822-36-6
Lock Date: 09/13/02
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: 92013-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC 4-METHYLIMIDAZOLE Date: 12/06/04
Route: DOSED FEED Time: 08:36:54
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 PPM 1250 PPM 2500 PPM 5000 PPM
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially in Study 50 50 50 50
Early Deaths
Natural Death 2 6 11 6
Moribund Sacrifice 5 5 5 9
Survivors
Terminal Sacrifice 40 39 34 33
Natural Death 3 2
Animals Examined Microscopically 50 50 50 50
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ALIMENTARY SYSTEM
Intestine Large, Colon (49) (48) (45) (46)
Histiocytic Sarcoma 1 (2%)
Intestine Large, Cecum (48) (46) (43) (43)
Intestine Small, Duodenum (49) (48) (43) (45)
Intestine Small, Ileum (45) (47) (42) (43)
Liver (50) (50) (48) (50)
Cholangiocarcinoma 1 (2%)
Hepatocellular Adenoma 1 (2%) 2 (4%)
Histiocytic Sarcoma 2 (4%)
Osteosarcoma, Metastatic, Uncertain Primary
Site 1 (2%)
Mesentery (9) (7) (11) (8)
Fibrosarcoma 1 (11%)
Histiocytic Sarcoma 1 (11%)
Pancreas (49) (49) (47) (47)
Histiocytic Sarcoma 1 (2%)
Salivary Glands (50) (50) (50) (50)
Stomach, Forestomach (50) (50) (49) (50)
Stomach, Glandular (50) (50) (49) (49)
Tongue (5) (4) (3)
Squamous Cell Papilloma 1 (20%) 1 (25%) 1 (33%)
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NTP Experiment-Test: 92013-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC 4-METHYLIMIDAZOLE Date: 12/06/04
Route: DOSED FEED Time: 08:36:54
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 PPM 1250 PPM 2500 PPM 5000 PPM
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (50) (50) (48) (50)
Schwannoma Benign 1 (2%) 1 (2%) 3 (6%)
Schwannoma Benign, Multiple 1 (2%)
Schwannoma Malignant 1 (2%)
Epicardium, Alveolar/Bronchiolar Carcinoma,
Metastatic, Lung 1 (2%)
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ENDOCRINE SYSTEM
Adrenal Cortex (49) (50) (50) (50)
Adenoma 1 (2%) 1 (2%) 1 (2%)
Carcinoma 1 (2%)
Adrenal Medulla (48) (50) (50) (50)
Pheochromocytoma Malignant 1 (2%)
Pheochromocytoma Benign 1 (2%) 1 (2%) 2 (4%) 2 (4%)
Bilateral, Pheochromocytoma Benign 1 (2%)
Islets, Pancreatic (49) (50) (48) (47)
Adenoma 1 (2%)
Mixed Tumor Benign 1 (2%)
Pituitary Gland (48) (50) (50) (50)
Pars Distalis, Adenoma 29 (60%) 19 (38%) 20 (40%) 9 (18%)
Pars Distalis, Carcinoma 1 (2%)
Thyroid Gland (47) (44) (40) (45)
Bilateral, C-Cell, Adenoma 1 (3%)
C-Cell, Adenoma 10 (21%) 8 (18%) 5 (13%) 8 (18%)
C-Cell, Carcinoma 1 (2%) 2 (5%)
Follicular Cell, Adenoma 2 (4%) 3 (7%)
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GENERAL BODY SYSTEM
Tissue NOS (5) (3) (6) (6)
Neoplasm NOS 1 (17%)
Mediastinum, Alveolar/Bronchiolar Carcinoma,
Metastatic, Lung 1 (33%)
Mediastinum, Schwannoma Malignant 1 (20%)
____________________________________________________________________________________________________________________________________
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NTP Experiment-Test: 92013-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC 4-METHYLIMIDAZOLE Date: 12/06/04
Route: DOSED FEED Time: 08:36:54
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 PPM 1250 PPM 2500 PPM 5000 PPM
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Clitoral Gland (50) (50) (50) (50)
Adenoma 8 (16%) 1 (2%)
Carcinoma 2 (4%) 1 (2%)
Ovary (50) (50) (48) (50)
Granulosa-Theca Tumor Malignant 1 (2%)
Histiocytic Sarcoma 1 (2%)
Oviduct (2) (1)
Uterus (50) (50) (48) (50)
Carcinoma 1 (2%)
Endometrium, Polyp Stromal 16 (32%) 5 (10%) 2 (4%) 2 (4%)
Endometrium, Sarcoma Stromal 1 (2%)
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HEMATOPOIETIC SYSTEM
Bone Marrow (50) (48) (49) (48)
Osteosarcoma, Metastatic, Bone 1 (2%)
Lymph Node (24) (11) (24) (35)
Mediastinal, Carcinoma, Metastatic, Thyroid
Gland 1 (4%)
Pancreatic, Histiocytic Sarcoma 2 (8%)
Lymph Node, Mandibular (1) (3) (1) (4)
Lymph Node, Mesenteric (49) (49) (49) (47)
Spleen (50) (48) (47) (48)
Histiocytic Sarcoma 1 (2%)
Thymus (47) (50) (48) (48)
Alveolar/Bronchiolar Carcinoma, Metastatic,
Lung 1 (2%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (50) (49) (50) (50)
Carcinoma 2 (4%) 1 (2%) 2 (4%)
Fibroadenoma 20 (40%) 5 (10%) 3 (6%) 1 (2%)
Fibroadenoma, Multiple 4 (8%) 1 (2%) 1 (2%)
Skin (50) (50) (50) (50)
Basal Cell Adenoma 1 (2%)
Squamous Cell Papilloma 1 (2%)
Trichoepithelioma 1 (2%)
Pinna, Neural Crest Tumor 1 (2%)
Subcutaneous Tissue, Fibroma 1 (2%) 1 (2%) 5 (10%)
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NTP Experiment-Test: 92013-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC 4-METHYLIMIDAZOLE Date: 12/06/04
Route: DOSED FEED Time: 08:36:54
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 PPM 1250 PPM 2500 PPM 5000 PPM
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM - cont
Subcutaneous Tissue, Histiocytic Sarcoma 1 (2%)
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MUSCULOSKELETAL SYSTEM
Bone (50) (50) (50) (50)
Osteosarcoma 1 (2%) 1 (2%)
Maxilla, Sarcoma 1 (2%)
Skeletal Muscle (1) (1)
Alveolar/Bronchiolar Carcinoma, Metastatic,
Lung 1 (100%)
Carcinoma, Metastatic, Thyroid Gland 1 (100%)
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NERVOUS SYSTEM
Brain (50) (50) (50) (50)
Astrocytoma Malignant 1 (2%)
Carcinoma, Metastatic, Pituitary Gland 1 (2%)
Spinal Cord (7) (3) (24) (50)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Larynx (1)
Carcinoma, Metastatic, Thyroid Gland 1 (100%)
Lung (50) (50) (50) (50)
Alveolar/Bronchiolar Carcinoma 2 (4%)
Histiocytic Sarcoma, Metastatic, Uncertain
Primary Site 1 (2%)
Osteosarcoma, Metastatic, Bone 1 (2%)
Nose (49) (50) (50) (50)
Trachea (50) (50) (50) (50)
Carcinoma, Metastatic, Thyroid Gland 1 (2%)
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SPECIAL SENSES SYSTEM
Eye (48) (45) (40) (45)
Lids, Neural Crest Tumor 1 (2%) 1 (3%)
Harderian Gland (50) (50) (50) (50)
Zymbal's Gland (3) (1)
Carcinoma 1 (33%) 1 (100%)
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NTP Experiment-Test: 92013-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC 4-METHYLIMIDAZOLE Date: 12/06/04
Route: DOSED FEED Time: 08:36:54
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 PPM 1250 PPM 2500 PPM 5000 PPM
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM - cont
Carcinosarcoma 1 (33%)
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URINARY SYSTEM
Kidney (48) (48) (43) (43)
Bilateral, Renal Tubule, Adenoma 1 (2%)
Pelvis, Transitional Epithelium, Papilloma 1 (2%)
Urinary Bladder (49) (50) (49) (48)
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SYSTEMIC LESIONS
Multiple Organs *(50) *(50) *(50) *(50)
Histiocytic Sarcoma 2 (4%)
Leukemia Mononuclear 9 (18%) 7 (14%) 16 (32%) 20 (40%)
____________________________________________________________________________________________________________________________________
* Number of animals with any tissue examined microscopically
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NTP Experiment-Test: 92013-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC 4-METHYLIMIDAZOLE Date: 12/06/04
Route: DOSED FEED Time: 08:36:54
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 PPM 1250 PPM 2500 PPM 5000 PPM
____________________________________________________________________________________________________________________________________
TUMOR SUMMARY
Total Animals with Primary Neoplasms (b) 48 39 42 36
Total Primary Neoplasms 118 67 73 49
Total Animals with Benign Neoplasms 48 32 29 20
Total Benign Neoplasms 97 49 46 27
Total Animals with Malignant Neoplasms 19 15 24 21
Total Malignant Neoplasms 21 17 25 21
Total Animals with Metastatic Neoplasms 3 3 2
Total Metastatic Neoplasm 3 6 4
Total Animals with Malignant Neoplasms 1 1
Uncertain Primary Site
Total Animals with Neoplasms Uncertain-
Benign or Malignant 1 2 1
Total Uncertain Neoplasms 1 2 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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NTP Experiment-Test: 92013-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC 4-METHYLIMIDAZOLE Date: 12/06/04
Route: DOSED FEED Time: 08:36:54
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 PPM 625 PPM 1250 PPM 2500 PPM
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially in Study 50 50 50 50
Early Deaths
Moribund Sacrifice 13 11 12 10
Natural Death 6 5 5 8
Survivors
Terminal Sacrifice 31 34 33 32
Animals Examined Microscopically 50 50 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Intestine Large, Colon (48) (49) (49) (46)
Intestine Large, Cecum (46) (46) (46) (46)
Intestine Small, Duodenum (49) (48) (47) (47)
Intestine Small, Jejunum (47) (45) (45) (43)
Intestine Small, Ileum (46) (45) (45) (44)
Liver (50) (50) (50) (50)
Basal Cell Carcinoma, Metastatic, Skin 1 (2%)
Histiocytic Sarcoma 1 (2%)
Ito Cell Tumor Benign 1 (2%)
Mesentery (13) (10) (11) (10)
Basal Cell Carcinoma, Metastatic, Skin 1 (9%)
Histiocytic Sarcoma 1 (10%)
Pancreas (50) (48) (48) (49)
Acinus, Adenoma 1 (2%) 2 (4%)
Salivary Glands (50) (50) (50) (50)
Fibrosarcoma 1 (2%)
Stomach, Forestomach (50) (50) (50) (49)
Stomach, Glandular (50) (50) (49) (49)
Tongue (3) (1) (1)
Squamous Cell Carcinoma 1 (33%)
Squamous Cell Papilloma 1 (33%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (50) (50) (50) (50)
____________________________________________________________________________________________________________________________________
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NTP Experiment-Test: 92013-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC 4-METHYLIMIDAZOLE Date: 12/06/04
Route: DOSED FEED Time: 08:36:54
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 PPM 625 PPM 1250 PPM 2500 PPM
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (50) (50) (50) (50)
Adenoma 1 (2%)
Adrenal Medulla (50) (50) (50) (50)
Pheochromocytoma Malignant 2 (4%)
Pheochromocytoma Complex 2 (4%)
Pheochromocytoma Benign 6 (12%) 3 (6%) 3 (6%) 3 (6%)
Bilateral, Pheochromocytoma Benign 2 (4%) 2 (4%)
Islets, Pancreatic (50) (49) (49) (49)
Adenoma 3 (6%) 2 (4%) 1 (2%) 1 (2%)
Carcinoma 1 (2%)
Parathyroid Gland (48) (50) (48) (50)
Adenoma 1 (2%)
Pituitary Gland (49) (49) (48) (48)
Pars Distalis, Adenoma 16 (33%) 13 (27%) 10 (21%) 7 (15%)
Pars Intermedia, Adenoma 1 (2%)
Thyroid Gland (47) (46) (48) (44)
Chemodectoma Benign 1 (2%)
Bilateral, C-Cell, Adenoma 1 (2%) 1 (2%)
C-Cell, Adenoma 11 (23%) 6 (13%) 3 (6%) 9 (20%)
C-Cell, Carcinoma 2 (4%)
Follicular Cell, Adenoma 1 (2%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
Peritoneum (2) (3) (1)
Tissue NOS (6) (4) (6) (5)
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Epididymis (50) (50) (50) (50)
Preputial Gland (50) (50) (50) (49)
Adenoma 2 (4%) 1 (2%)
Carcinoma 1 (2%)
Prostate (50) (50) (50) (49)
Seminal Vesicle (50) (50) (50) (50)
Testes (50) (50) (50) (50)
Bilateral, Interstitial Cell, Adenoma 40 (80%) 40 (80%) 34 (68%) 31 (62%)
Interstitial Cell, Adenoma 6 (12%) 4 (8%) 13 (26%) 14 (28%)
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NTP Experiment-Test: 92013-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC 4-METHYLIMIDAZOLE Date: 12/06/04
Route: DOSED FEED Time: 08:36:54
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 PPM 625 PPM 1250 PPM 2500 PPM
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (47) (50) (48) (50)
Lymph Node (19) (18) (26) (27)
Lymph Node, Mandibular (1) (1) (2)
Lymph Node, Mesenteric (50) (48) (48) (49)
Spleen (50) (48) (48) (49)
Fibroma 1 (2%)
Thymus (48) (49) (46) (45)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (47) (46) (41) (45)
Fibroadenoma 3 (6%) 1 (2%) 1 (2%) 1 (2%)
Skin (50) (50) (50) (50)
Basal Cell Adenoma 1 (2%) 1 (2%) 2 (4%)
Basal Cell Carcinoma 1 (2%)
Keratoacanthoma 1 (2%) 3 (6%)
Squamous Cell Carcinoma 1 (2%)
Subcutaneous Tissue, Fibroma 7 (14%) 2 (4%) 4 (8%) 3 (6%)
Subcutaneous Tissue, Fibroma, Multiple 1 (2%)
Subcutaneous Tissue, Hemangioma 1 (2%)
Subcutaneous Tissue, Histiocytic Sarcoma 1 (2%)
Subcutaneous Tissue, Lipoma 1 (2%)
Subcutaneous Tissue, Sarcoma 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Skeletal Muscle (2) (2)
Histiocytic Sarcoma 1 (50%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (50) (50) (50)
Astrocytoma Malignant 1 (2%)
Glioma Malignant 1 (2%) 1 (2%)
Pineal Gland, Neoplasm NOS 1 (2%)
Spinal Cord (2) (3) (2) (3)
____________________________________________________________________________________________________________________________________
Page 10
NTP Experiment-Test: 92013-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC 4-METHYLIMIDAZOLE Date: 12/06/04
Route: DOSED FEED Time: 08:36:54
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 PPM 625 PPM 1250 PPM 2500 PPM
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (50) (50) (50)
Alveolar/Bronchiolar Adenoma 1 (2%) 1 (2%)
Alveolar/Bronchiolar Carcinoma 1 (2%)
Basal Cell Carcinoma, Metastatic, Skin 1 (2%)
Chordoma, Metastatic, Uncertain Primary Site 1 (2%)
Nose (49) (50) (50) (50)
Olfactory Epithelium, Carcinoma 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Harderian Gland (50) (50) (50) (50)
Zymbal's Gland (3) (1) (2)
Carcinoma 3 (100%) 1 (100%) 2 (100%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (48) (49) (48) (50)
Histiocytic Sarcoma 1 (2%)
Sarcoma 1 (2%)
Urinary Bladder (49) (50) (50) (50)
Transitional Epithelium, Papilloma 1 (2%)
____________________________________________________________________________________________________________________________________
SYSTEMIC LESIONS
Multiple Organs *(50) *(50) *(50) *(50)
Histiocytic Sarcoma 1 (2%) 1 (2%)
Leukemia Mononuclear 15 (30%) 18 (36%) 22 (44%) 20 (40%)
Lymphoma Malignant 1 (2%)
Mesothelioma Malignant 2 (4%) 3 (6%) 1 (2%)
____________________________________________________________________________________________________________________________________
* Number of animals with any tissue examined microscopically
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NTP Experiment-Test: 92013-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC 4-METHYLIMIDAZOLE Date: 12/06/04
Route: DOSED FEED Time: 08:36:54
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 PPM 625 PPM 1250 PPM 2500 PPM
____________________________________________________________________________________________________________________________________
TUMOR SUMMARY
Total Animals with Primary Neoplasms (b) 50 49 50 50
Total Primary Neoplasms 124 104 114 103
Total Animals with Benign Neoplasms 50 49 48 47
Total Benign Neoplasms 102 79 76 78
Total Animals with Malignant Neoplasms 22 21 30 23
Total Malignant Neoplasms 22 24 38 25
Total Animals with Metastatic Neoplasms 2 1
Total Metastatic Neoplasm 19 1
Total Animals with Malignant Neoplasms 1 1
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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