TDMS Study 92012-05 Pathology Tables
NTP Experiment-Test: 92012-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC 2-METHYLIMIDAZOLE Date: 02/24/03
Route: DOSED FEED Time: 14:26:13
FINAL #1/RATS
Facility: Southern Research Institute
Chemical CAS #: 693-98-1
Lock Date: 10/16/01
Cage Range: All
Reasons For Removal: 25019 Moribund Sacrifice 25020 Natural Death
25021 Terminal Sacrifice
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: 92012-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC 2-METHYLIMIDAZOLE Date: 02/24/03
Route: DOSED FEED Time: 14:26:13
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0PPM 1000 PPM 2500 PPM 5000 PPM
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially in Study 60 60 60 60
Early Deaths
Natural Death 4 3 10 1
Moribund Sacrifice 6 8 12 7
Survivors
Terminal Sacrifice 40 39 28 41
Natural Death 1
Animals Examined Microscopically 50 50 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Intestine Large, Colon (48) (49) (48) (50)
Intestine Large, Rectum (47) (48) (50) (49)
Intestine Large, Cecum (48) (47) (44) (50)
Intestine Small, Duodenum (48) (49) (49) (50)
Intestine Small, Jejunum (47) (46) (44) (49)
Intestine Small, Ileum (48) (46) (44) (50)
Liver (50) (49) (50) (50)
Cholangiocarcinoma 1 (2%) 1 (2%)
Hepatocellular Adenoma 1 (2%) 2 (4%) 3 (6%)
Hepatocellular Adenoma, Multiple 1 (2%)
Mesentery (8) (10) (12) (9)
Nerve, Schwannoma Malignant 1 (11%)
Pancreas (50) (49) (49) (50)
Salivary Glands (50) (49) (50) (50)
Stomach, Forestomach (50) (50) (50) (50)
Squamous Cell Papilloma 1 (2%)
Stomach, Glandular (49) (49) (48) (50)
Tongue (3) (1)
Liposarcoma 1 (33%)
Squamous Cell Papilloma 1 (100%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (50) (49) (50) (50)
Squamous Cell Carcinoma, Metastatic, Skin 1 (2%)
____________________________________________________________________________________________________________________________________
Page 2
NTP Experiment-Test: 92012-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC 2-METHYLIMIDAZOLE Date: 02/24/03
Route: DOSED FEED Time: 14:26:13
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0PPM 1000 PPM 2500 PPM 5000 PPM
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (50) (49) (50) (50)
Adenoma 5 (10%)
Adrenal Medulla (49) (49) (50) (50)
Pheochromocytoma Malignant 1 (2%)
Pheochromocytoma Benign 2 (4%)
Islets, Pancreatic (50) (49) (50) (50)
Adenoma 1 (2%) 1 (2%)
Carcinoma 2 (4%)
Pituitary Gland (50) (48) (50) (50)
Pars Distalis, Adenoma 23 (46%) 24 (50%) 21 (42%) 13 (26%)
Pars Distalis, Carcinoma 2 (4%) 1 (2%) 3 (6%)
Pars Intermedia, Adenoma 1 (2%)
Thyroid Gland (49) (48) (42) (48)
Bilateral, C-Cell, Adenoma 1 (2%)
Bilateral, C-Cell, Adenoma, Multiple 1 (2%)
Bilateral, Follicular Cell, Adenoma 1 (2%)
Bilateral, Follicular Cell, Carcinoma 1 (2%)
C-Cell, Adenoma 7 (14%) 8 (17%) 8 (19%) 3 (6%)
C-Cell, Adenoma, Multiple 1 (2%)
C-Cell, Carcinoma 1 (2%) 1 (2%)
Follicular Cell, Adenoma 4 (8%)
Follicular Cell, Carcinoma 1 (2%) 1 (2%) 1 (2%) 6 (13%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
Tissue NOS (3) (4) (2)
Mediastinum, Squamous Cell Carcinoma,
Metastatic, Skin 1 (25%)
Thoracic, Fibrosarcoma 1 (33%)
Thoracic, Rhabdomyosarcoma 1 (25%)
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Clitoral Gland (50) (49) (50) (50)
Adenoma 5 (10%) 4 (8%) 5 (10%)
Carcinoma 3 (6%) 1 (2%) 1 (2%) 1 (2%)
Squamous Cell Papilloma 1 (2%)
Bilateral, Adenoma 1 (2%)
Bilateral, Carcinoma, Multiple 1 (2%)
Ovary (50) (49) (50) (50)
Page 3
NTP Experiment-Test: 92012-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC 2-METHYLIMIDAZOLE Date: 02/24/03
Route: DOSED FEED Time: 14:26:13
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0PPM 1000 PPM 2500 PPM 5000 PPM
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM - cont
Granulosa Cell Tumor Benign 1 (2%)
Granulosa-Theca Tumor Benign 1 (2%)
Uterus (50) (50) (50) (50)
Endometrium, Polyp Stromal 7 (14%) 6 (12%) 7 (14%) 3 (6%)
Endometrium, Polyp Stromal, Multiple 1 (2%)
Vagina (2) (2)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (49) (50) (50) (50)
Lymph Node (32) (31) (34) (41)
Lymph Node, Mesenteric (49) (49) (49) (50)
Spleen (50) (49) (48) (50)
Thymus (48) (45) (49) (49)
Thymoma Malignant 1 (2%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (50) (50) (50) (50)
Carcinoma 4 (8%) 1 (2%) 3 (6%) 1 (2%)
Fibroadenoma 24 (48%) 18 (36%) 18 (36%) 5 (10%)
Fibroadenoma, Multiple 2 (4%) 5 (10%) 6 (12%) 1 (2%)
Skin (50) (50) (50) (50)
Basal Cell Adenoma 1 (2%)
Basal Cell Carcinoma 1 (2%)
Keratoacanthoma 1 (2%)
Squamous Cell Carcinoma, Multiple 1 (2%)
Subcutaneous Tissue, Fibroma 1 (2%) 2 (4%) 2 (4%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Skeletal Muscle (1) (1) (2)
Rhabdomyosarcoma 1 (100%) 1 (50%)
____________________________________________________________________________________________________________________________________
Page 4
NTP Experiment-Test: 92012-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC 2-METHYLIMIDAZOLE Date: 02/24/03
Route: DOSED FEED Time: 14:26:13
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0PPM 1000 PPM 2500 PPM 5000 PPM
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (49) (50) (50)
Glioma Malignant, Mixed Cell 1 (2%)
Spinal Cord (3) (1) (4)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (49) (50) (50)
Alveolar/Bronchiolar Adenoma 1 (2%) 1 (2%) 1 (2%)
Rhabdomyosarcoma, Metastatic, Tissue NOS 1 (2%)
Squamous Cell Carcinoma, Metastatic, Skin 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (50) (49) (49) (50)
Harderian Gland (50) (49) (50) (50)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (48) (47) (50)
Sarcoma 1 (2%)
Squamous Cell Carcinoma, Metastatic, Skin 1 (2%)
Urinary Bladder (50) (49) (49) (50)
Transitional Epithelium, Papilloma 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
SYSTEMIC LESIONS
Multiple Organs *(50) *(50) *(50) *(50)
Leukemia Mononuclear 6 (12%) 4 (8%) 9 (18%) 10 (20%)
____________________________________________________________________________________________________________________________________
* Number of animals with any tissue examined microscopically
Page 5
NTP Experiment-Test: 92012-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC 2-METHYLIMIDAZOLE Date: 02/24/03
Route: DOSED FEED Time: 14:26:13
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0PPM 1000 PPM 2500 PPM 5000 PPM
____________________________________________________________________________________________________________________________________
TUMOR SUMMARY
Total Animals with Primary Neoplasms (b) 45 44 48 38
Total Primary Neoplasms 103 82 97 64
Total Animals with Benign Neoplasms 43 43 40 27
Total Benign Neoplasms 81 71 75 40
Total Animals with Malignant Neoplasms 19 10 21 20
Total Malignant Neoplasms 22 11 22 24
Total Animals with Metastatic Neoplasms 2
Total Metastatic Neoplasm 5
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: 92012-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC 2-METHYLIMIDAZOLE Date: 02/24/03
Route: DOSED FEED Time: 14:26:13
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0PPM 300 PPM 1000 PPM 3000 PPM
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially in Study 60 60 60 60
Early Deaths
Moribund Sacrifice 13 6 7 13
Natural Death 2 4 7 2
Survivors
Terminal Sacrifice 34 39 35 35
Moribund Sacrifice 1
Natural Death 1 1
Animals Examined Microscopically 50 50 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Intestine Large, Colon (50) (49) (48) (50)
Intestine Large, Rectum (49) (48) (48) (50)
Intestine Large, Cecum (48) (45) (45) (49)
Lipoma 1 (2%)
Intestine Small, Duodenum (49) (49) (48) (50)
Intestine Small, Jejunum (47) (45) (44) (48)
Leiomyosarcoma 1 (2%)
Intestine Small, Ileum (47) (46) (45) (48)
Liver (50) (50) (50) (50)
Cholangiocarcinoma 1 (2%) 2 (4%) 2 (4%) 1 (2%)
Cholangioma 2 (4%)
Hemangiosarcoma 1 (2%)
Hepatocellular Carcinoma 1 (2%) 2 (4%)
Hepatocellular Adenoma 1 (2%) 3 (6%) 1 (2%)
Hepatocellular Adenoma, Multiple 1 (2%)
Mesentery (26) (46) (35) (20)
Hemangiosarcoma 1 (4%) 1 (2%)
Oral Mucosa (1)
Squamous Cell Papilloma 1 (100%)
Pancreas (49) (49) (50) (50)
Acinus, Adenoma 1 (2%)
Salivary Glands (50) (50) (50) (50)
Stomach, Forestomach (50) (50) (50) (49)
Stomach, Glandular (50) (50) (50) (49)
Adenoma 1 (2%)
____________________________________________________________________________________________________________________________________
Page 7
NTP Experiment-Test: 92012-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC 2-METHYLIMIDAZOLE Date: 02/24/03
Route: DOSED FEED Time: 14:26:13
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0PPM 300 PPM 1000 PPM 3000 PPM
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (50) (50) (50) (50)
Pericardium, Epicardium,
Alveolar/Bronchiolar Carcinoma,
Metastatic, Lung 1 (2%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (50) (50) (50) (50)
Adenoma 1 (2%)
Adrenal Medulla (50) (50) (50) (50)
Pheochromocytoma Malignant 1 (2%) 3 (6%) 1 (2%)
Pheochromocytoma Benign 7 (14%) 2 (4%) 6 (12%) 6 (12%)
Schwannoma Malignant, Metastatic, Adrenal
Medulla 1 (2%)
Bilateral, Pheochromocytoma Benign 1 (2%) 1 (2%)
Islets, Pancreatic (50) (49) (50) (50)
Adenoma 1 (2%) 3 (6%)
Carcinoma 3 (6%)
Pituitary Gland (50) (50) (50) (50)
Pars Distalis, Adenoma 9 (18%) 6 (12%) 8 (16%) 8 (16%)
Pars Distalis, Adenoma, Multiple 1 (2%)
Pars Intermedia, Adenoma 1 (2%)
Thyroid Gland (48) (46) (43) (50)
Bilateral, C-Cell, Adenoma 1 (2%)
Bilateral, C-Cell, Adenoma, Multiple 1 (2%)
C-Cell, Adenoma 8 (17%) 5 (11%) 9 (21%) 6 (12%)
C-Cell, Carcinoma 1 (2%) 3 (6%)
Follicular Cell, Adenoma 1 (2%) 1 (2%) 3 (6%)
Follicular Cell, Carcinoma 2 (4%) 2 (4%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
Peritoneum (1) (3)
Tissue NOS (7) (2) (6) (4)
Sarcoma 1 (14%)
Mediastinum, Alveolar/Bronchiolar Carcinoma,
Metastatic, Lung 1 (17%)
Thoracic, Alveolar/Bronchiolar Carcinoma,
Metastatic, Lung 1 (17%)
____________________________________________________________________________________________________________________________________
Page 8
NTP Experiment-Test: 92012-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC 2-METHYLIMIDAZOLE Date: 02/24/03
Route: DOSED FEED Time: 14:26:13
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0PPM 300 PPM 1000 PPM 3000 PPM
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Epididymis (50) (50) (50) (50)
Preputial Gland (50) (50) (50) (50)
Adenoma 1 (2%) 2 (4%)
Adenoma, Cystic 1 (2%)
Carcinoma 1 (2%) 2 (4%) 3 (6%)
Bilateral, Carcinoma 1 (2%)
Prostate (50) (50) (50) (50)
Seminal Vesicle (50) (50) (50) (50)
Testes (50) (50) (50) (50)
Bilateral, Interstitial Cell, Adenoma 2 (4%)
Bilateral, Interstitial Cell, Adenoma,
Multiple 42 (84%) 36 (72%) 34 (68%) 28 (56%)
Interstitial Cell, Adenoma 3 (6%) 2 (4%) 6 (12%) 7 (14%)
Interstitial Cell, Adenoma, Multiple 1 (2%) 7 (14%) 2 (4%) 8 (16%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (50) (50) (47) (50)
Lymph Node (39) (49) (42) (38)
Deep Cervical, Carcinoma, Metastatic,
Zymbal's Gland 1 (2%)
Lymph Node, Mesenteric (47) (50) (50) (50)
Spleen (49) (49) (50) (50)
Thymus (48) (48) (44) (49)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (48) (47) (45) (42)
Fibroadenoma 2 (5%)
Skin (50) (50) (50) (50)
Basal Cell Carcinoma 2 (4%)
Keratoacanthoma 1 (2%) 2 (4%) 1 (2%) 4 (8%)
Melanoma Benign 1 (2%)
Osteosarcoma, Metastatic, Uncertain Primary
Site 1 (2%)
Trichoepithelioma 1 (2%) 1 (2%) 1 (2%)
Dermis, Fibroma 1 (2%)
Pinna, Schwannoma Malignant 1 (2%)
Sebaceous Gland, Adenoma 1 (2%)
Page 9
NTP Experiment-Test: 92012-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC 2-METHYLIMIDAZOLE Date: 02/24/03
Route: DOSED FEED Time: 14:26:13
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0PPM 300 PPM 1000 PPM 3000 PPM
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM - cont
Subcutaneous Tissue, Fibroma 1 (2%) 3 (6%) 2 (4%)
Subcutaneous Tissue, Fibroma, Multiple 1 (2%)
Subcutaneous Tissue, Fibrosarcoma 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (50) (50) (50) (50)
Osteosarcoma 1 (2%)
Cranium, Carcinoma, Metastatic, Zymbal's
Gland 1 (2%)
Cranium, Osteoma 2 (4%)
Cranium, Osteosarcoma 1 (2%)
Skeletal Muscle (2) (1) (1) (4)
Hemangiosarcoma 1 (50%)
Rhabdomyosarcoma 1 (25%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (50) (50) (50)
Astrocytoma Malignant 1 (2%)
Spinal Cord (1) (1)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (50) (50) (50)
Alveolar/Bronchiolar Adenoma 2 (4%) 2 (4%) 2 (4%) 1 (2%)
Alveolar/Bronchiolar Carcinoma 2 (4%) 1 (2%) 1 (2%)
Alveolar/Bronchiolar Carcinoma, Multiple 1 (2%)
Carcinoma, Metastatic, Preputial Gland 1 (2%)
Carcinoma, Metastatic, Zymbal's Gland 1 (2%)
Osteosarcoma, Metastatic, Bone 1 (2%)
Alveolar Epithelium, Carcinoma 1 (2%)
Nose (50) (50) (50) (50)
Glands, Adenoma 1 (2%)
____________________________________________________________________________________________________________________________________
Page 10
NTP Experiment-Test: 92012-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC 2-METHYLIMIDAZOLE Date: 02/24/03
Route: DOSED FEED Time: 14:26:13
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0PPM 300 PPM 1000 PPM 3000 PPM
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Harderian Gland (50) (50) (49) (50)
Zymbal's Gland (1) (2)
Carcinoma 1 (100%) 2 (100%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (49) (49) (49) (50)
Urinary Bladder (50) (50) (49) (50)
____________________________________________________________________________________________________________________________________
SYSTEMIC LESIONS
Multiple Organs *(50) *(50) *(50) *(50)
Leukemia Mononuclear 15 (30%) 14 (28%) 21 (42%) 10 (20%)
Lymphoma Malignant 1 (2%)
Mesothelioma Malignant 2 (4%) 4 (8%) 2 (4%)
____________________________________________________________________________________________________________________________________
* Number of animals with any tissue examined microscopically
Page 11
NTP Experiment-Test: 92012-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC 2-METHYLIMIDAZOLE Date: 02/24/03
Route: DOSED FEED Time: 14:26:13
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0PPM 300 PPM 1000 PPM 3000 PPM
____________________________________________________________________________________________________________________________________
TUMOR SUMMARY
Total Animals with Primary Neoplasms (b) 50 49 49 48
Total Primary Neoplasms 111 104 118 115
Total Animals with Benign Neoplasms 49 46 47 45
Total Benign Neoplasms 86 72 80 85
Total Animals with Malignant Neoplasms 22 26 30 25
Total Malignant Neoplasms 25 32 38 30
Total Animals with Metastatic Neoplasms 1 2 2 2
Total Metastatic Neoplasm 1 4 4 2
Total Animals with Malignant Neoplasms 1
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 ----------
------------------------------------------------------------