TDMS Study 92013-06 Pathology Tables
NTP Experiment-Test: 92013-06 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC 4-METHYLIMIDAZOLE Date: 01/12/04 Route: DOSED FEED Time: 14:34:49 FINAL #1 MICE 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 Page 1 NTP Experiment-Test: 92013-06 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC 4-METHYLIMIDAZOLE Date: 01/12/04 Route: DOSED FEED Time: 14:34:49 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0 PPM 312 PPM 625 PPM 1250 PPM ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially in Study 50 50 50 50 Early Deaths Moribund Sacrifice 3 4 3 3 Natural Death 4 6 4 7 Survivors Terminal Sacrifice 42 40 41 39 Natural Death 1 2 1 Animals Examined Microscopically 50 50 50 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Colon (48) (50) (50) (49) Squamous Cell Carcinoma, Metastatic, Stomach, Forestomach 1 (2%) Intestine Large, Cecum (49) (48) (46) (46) Histiocytic Sarcoma 1 (2%) Intestine Small, Duodenum (48) (47) (49) (48) Carcinoma 2 (4%) Histiocytic Sarcoma 1 (2%) Polyp Adenomatous 1 (2%) Intestine Small, Jejunum (50) (48) (47) (47) Intestine Small, Ileum (48) (45) (48) (48) Liver (50) (50) (50) (50) Hepatocellular Carcinoma 1 (2%) 2 (4%) 1 (2%) Hepatocellular Adenoma 4 (8%) 5 (10%) 1 (2%) Histiocytic Sarcoma 1 (2%) 1 (2%) 2 (4%) Mast Cell Tumor Malignant 1 (2%) Sarcoma, Metastatic, Skin 1 (2%) Squamous Cell Carcinoma, Metastatic, Stomach, Forestomach 1 (2%) Mesentery (3) (7) (7) (4) Carcinoma, Metastatic, Mammary Gland 1 (14%) Histiocytic Sarcoma 1 (14%) Squamous Cell Carcinoma, Metastatic, Stomach, Forestomach 1 (14%) Pancreas (49) (48) (48) (49) Sarcoma, Metastatic, Skin 1 (2%) Salivary Glands (50) (48) (50) (49) Stomach, Forestomach (50) (50) (50) (50) Page 2 NTP Experiment-Test: 92013-06 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC 4-METHYLIMIDAZOLE Date: 01/12/04 Route: DOSED FEED Time: 14:34:49 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0 PPM 312 PPM 625 PPM 1250 PPM ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - cont Squamous Cell Carcinoma 2 (4%) Squamous Cell Papilloma 2 (4%) 1 (2%) 2 (4%) Stomach, Glandular (49) (49) (50) (49) Adenoma 1 (2%) Sarcoma, Metastatic, Skin 1 (2%) Squamous Cell Carcinoma, Metastatic, Stomach, Forestomach 1 (2%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (50) (50) (50) (50) Carcinoma, Metastatic, Mammary Gland 1 (2%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (50) (50) (50) (50) Carcinoma, Metastatic, Mammary Gland 1 (2%) Capsule, Adenoma 1 (2%) Adrenal Medulla (50) (50) (50) (50) Pheochromocytoma Malignant 1 (2%) 1 (2%) Pheochromocytoma Benign 1 (2%) Islets, Pancreatic (49) (48) (47) (49) Adenoma 3 (6%) Carcinoma 1 (2%) 1 (2%) Pituitary Gland (49) (46) (49) (50) Pars Distalis, Adenoma 5 (10%) 4 (9%) 3 (6%) 2 (4%) Thyroid Gland (50) (49) (50) (48) Bilateral, Adenoma 1 (2%) Follicular Cell, Adenoma 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ Page 3 NTP Experiment-Test: 92013-06 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC 4-METHYLIMIDAZOLE Date: 01/12/04 Route: DOSED FEED Time: 14:34:49 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0 PPM 312 PPM 625 PPM 1250 PPM ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Ovary (48) (49) (49) (50) Cystadenoma 2 (4%) 1 (2%) 1 (2%) Granulosa Cell Tumor Benign 2 (4%) Hemangiosarcoma 1 (2%) Histiocytic Sarcoma 1 (2%) Luteoma 1 (2%) 2 (4%) 2 (4%) Tubulostromal Adenoma 1 (2%) 1 (2%) Uterus (50) (50) (50) (50) Carcinoma 1 (2%) Hemangiosarcoma 1 (2%) 1 (2%) Histiocytic Sarcoma 1 (2%) 1 (2%) 2 (4%) 2 (4%) Leiomyoma 1 (2%) Polyp Stromal 2 (4%) 2 (4%) Sarcoma, Metastatic, Skin 1 (2%) Sarcoma Stromal 1 (2%) Schwannoma Malignant 1 (2%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (50) (50) (50) (50) Hemangiosarcoma 1 (2%) 1 (2%) Histiocytic Sarcoma 1 (2%) Mast Cell Tumor Malignant 1 (2%) Lymph Node (3) (9) (12) (7) Iliac, Histiocytic Sarcoma 1 (11%) Mediastinal, Histiocytic Sarcoma 1 (14%) Pancreatic, Squamous Cell Carcinoma, Metastatic, Stomach, Forestomach 1 (8%) Lymph Node, Mandibular (47) (47) (48) (48) Histiocytic Sarcoma 1 (2%) Lymph Node, Mesenteric (49) (47) (49) (50) Histiocytic Sarcoma 1 (2%) Mast Cell Tumor Malignant 1 (2%) Sarcoma, Metastatic, Skin 1 (2%) Spleen (49) (49) (49) (49) Fibrosarcoma, Metastatic, Skin 1 (2%) Hemangiosarcoma 2 (4%) 2 (4%) Histiocytic Sarcoma 1 (2%) Mast Cell Tumor Malignant 1 (2%) Thymus (49) (49) (50) (48) ____________________________________________________________________________________________________________________________________ Page 4 NTP Experiment-Test: 92013-06 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC 4-METHYLIMIDAZOLE Date: 01/12/04 Route: DOSED FEED Time: 14:34:49 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0 PPM 312 PPM 625 PPM 1250 PPM ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (50) (50) (49) (49) Adenoma 1 (2%) Carcinoma 1 (2%) 1 (2%) 1 (2%) Skin (50) (50) (50) (50) Basal Cell Carcinoma 1 (2%) Subcutaneous Tissue, Fibrosarcoma 1 (2%) 1 (2%) Subcutaneous Tissue, Hemangiosarcoma 2 (4%) 1 (2%) Subcutaneous Tissue, Melanoma Benign 1 (2%) Subcutaneous Tissue, Sarcoma, Poorly Differentiated 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (50) (50) (50) (50) Osteosarcoma 1 (2%) Skeletal Muscle (1) (1) (2) (2) Sarcoma, Metastatic, Skin 1 (100%) Squamous Cell Carcinoma, Metastatic, Stomach, Forestomach 2 (100%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (50) (50) (50) Carcinoma, Metastatic, Mammary Gland 1 (2%) Histiocytic Sarcoma 1 (2%) Mast Cell Tumor Malignant 1 (2%) Spinal Cord (2) (1) Osteosarcoma, Metastatic, Bone 1 (100%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (50) (50) (50) Alveolar/Bronchiolar Adenoma 8 (16%) 12 (24%) 6 (12%) Alveolar/Bronchiolar Adenoma, Multiple 4 (8%) 2 (4%) Alveolar/Bronchiolar Carcinoma 3 (6%) 2 (4%) 6 (12%) Alveolar/Bronchiolar Carcinoma, Multiple 1 (2%) Carcinoma, Metastatic, Mammary Gland 1 (2%) Histiocytic Sarcoma 2 (4%) Page 5 NTP Experiment-Test: 92013-06 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC 4-METHYLIMIDAZOLE Date: 01/12/04 Route: DOSED FEED Time: 14:34:49 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0 PPM 312 PPM 625 PPM 1250 PPM ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM - cont Mast Cell Tumor Malignant 1 (2%) Osteosarcoma, Metastatic, Bone 1 (2%) Sarcoma, Metastatic, Skin 1 (2%) Nose (50) (49) (50) (50) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Harderian Gland (50) (50) (50) (50) Adenoma 6 (12%) 1 (2%) 5 (10%) 6 (12%) Carcinoma 1 (2%) 1 (2%) 2 (4%) Zymbal's Gland (1) (1) Carcinoma 1 (100%) 1 (100%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (49) (50) (50) (50) Carcinoma, Metastatic, Mammary Gland 1 (2%) Histiocytic Sarcoma 1 (2%) Urinary Bladder (50) (50) (50) (50) Histiocytic Sarcoma 1 (2%) Sarcoma, Metastatic, Skin 1 (2%) ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS Multiple Organs *(50) *(50) *(50) *(50) Histiocytic Sarcoma 1 (2%) 1 (2%) 3 (6%) 2 (4%) Lymphoma Malignant 7 (14%) 10 (20%) 12 (24%) 13 (26%) ____________________________________________________________________________________________________________________________________ * Number of animals with any tissue examined microscopically Page 6 NTP Experiment-Test: 92013-06 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC 4-METHYLIMIDAZOLE Date: 01/12/04 Route: DOSED FEED Time: 14:34:49 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0 PPM 312 PPM 625 PPM 1250 PPM ____________________________________________________________________________________________________________________________________ TUMOR SUMMARY Total Animals with Primary Neoplasms (b) 29 36 37 40 Total Primary Neoplasms 46 50 55 66 Total Animals with Benign Neoplasms 18 23 23 21 Total Benign Neoplasms 23 28 30 28 Total Animals with Malignant Neoplasms 20 20 23 29 Total Malignant Neoplasms 23 22 25 38 Total Animals with Metastatic Neoplasms 2 1 2 1 Total Metastatic Neoplasm 9 6 7 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 7 NTP Experiment-Test: 92013-06 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC 4-METHYLIMIDAZOLE Date: 01/12/04 Route: DOSED FEED Time: 14:34:49 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0 PPM 312 PPM 625 PPM 1250 PPM ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially in Study 50 50 50 50 Early Deaths Natural Death 4 6 8 Moribund Sacrifice 1 3 Survivors Natural Death 1 Terminal Sacrifice 44 44 42 46 Other 1 Animals Examined Microscopically 50 50 50 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Small, Duodenum (50) (49) (48) (50) Carcinoma 2 (4%) Polyp Adenomatous 1 (2%) Intestine Small, Jejunum (48) (47) (48) (50) Carcinoma 1 (2%) Intestine Small, Ileum (49) (46) (48) (49) Liver (50) (50) (50) (50) Hemangiosarcoma 1 (2%) 1 (2%) Hemangiosarcoma, Multiple 1 (2%) Hepatocellular Carcinoma 8 (16%) 11 (22%) 10 (20%) 7 (14%) Hepatocellular Carcinoma, Multiple 2 (4%) 2 (4%) 1 (2%) 3 (6%) Hepatocellular Adenoma 14 (28%) 7 (14%) 10 (20%) 11 (22%) Hepatocellular Adenoma, Multiple 3 (6%) 2 (4%) 1 (2%) Mesentery (4) (7) (2) (3) Hemangiosarcoma 1 (14%) 1 (33%) Hepatocellular Carcinoma, Metastatic, Liver 1 (14%) Sarcoma, Poorly Differentiated 1 (14%) Oral Mucosa (1) Squamous Cell Carcinoma 1 (100%) Pancreas (49) (49) (50) (50) Sarcoma, Metastatic, Mesentery 1 (2%) Salivary Glands (50) (50) (50) (50) Stomach, Forestomach (49) (50) (50) (50) Squamous Cell Carcinoma 1 (2%) Squamous Cell Papilloma 2 (4%) 3 (6%) Stomach, Glandular (49) (50) (49) (50) Hepatocellular Carcinoma, Metastatic, Liver 1 (2%) Page 8 NTP Experiment-Test: 92013-06 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC 4-METHYLIMIDAZOLE Date: 01/12/04 Route: DOSED FEED Time: 14:34:49 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0 PPM 312 PPM 625 PPM 1250 PPM ____________________________________________________________________________________________________________________________________ ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (50) (50) (50) (50) Hemangiosarcoma 1 (2%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (50) (50) (50) (50) Adenoma 1 (2%) Capsule, Adenoma 3 (6%) 1 (2%) 1 (2%) Capsule, Carcinoma 1 (2%) Islets, Pancreatic (49) (49) (50) (50) Adenoma 1 (2%) 1 (2%) Pituitary Gland (49) (48) (49) (50) Pars Distalis, Adenoma 1 (2%) Thyroid Gland (50) (50) (50) (50) Follicular Cell, Adenoma 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM Tissue NOS (1) Schwannoma Malignant 1 (100%) ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Prostate (50) (50) (50) (50) Carcinoma 1 (2%) Testes (50) (50) (50) (50) Hemangiosarcoma 1 (2%) 1 (2%) Interstitial Cell, Adenoma 2 (4%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (50) (50) (50) (50) Hemangiosarcoma 1 (2%) 1 (2%) Lymph Node (2) (2) (1) (2) Lymph Node, Mandibular (48) (50) (48) (45) Lymph Node, Mesenteric (49) (48) (48) (50) Page 9 NTP Experiment-Test: 92013-06 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC 4-METHYLIMIDAZOLE Date: 01/12/04 Route: DOSED FEED Time: 14:34:49 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0 PPM 312 PPM 625 PPM 1250 PPM ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - cont Spleen (49) (49) (50) (50) Hemangiosarcoma 1 (2%) 1 (2%) Thymus (48) (49) (45) (45) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Skin (50) (50) (50) (49) Squamous Cell Carcinoma 1 (2%) Sebaceous Gland, Adenoma 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Skeletal Muscle (1) (2) (1) (1) Carcinoma, Metastatic, Prostate 1 (100%) Hemangiosarcoma 1 (100%) Sarcoma, Metastatic, Mesentery 1 (50%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM None ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (50) (50) (50) Alveolar/Bronchiolar Adenoma 6 (12%) 10 (20%) 10 (20%) 14 (28%) Alveolar/Bronchiolar Adenoma, Multiple 2 (4%) 1 (2%) 3 (6%) 1 (2%) Alveolar/Bronchiolar Carcinoma 2 (4%) 3 (6%) 4 (8%) 7 (14%) Alveolar/Bronchiolar Carcinoma, Multiple 1 (2%) 1 (2%) Carcinoma, Metastatic, Prostate 1 (2%) Hepatocellular Carcinoma, Metastatic, Liver 3 (6%) 3 (6%) 3 (6%) 3 (6%) Schwannoma Malignant, Metastatic, Tissue NOS 1 (2%) Mediastinum, Hemangiosarcoma 1 (2%) ____________________________________________________________________________________________________________________________________ Page 10 NTP Experiment-Test: 92013-06 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC 4-METHYLIMIDAZOLE Date: 01/12/04 Route: DOSED FEED Time: 14:34:49 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0 PPM 312 PPM 625 PPM 1250 PPM ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Harderian Gland (50) (50) (50) (50) Adenoma 3 (6%) 8 (16%) 4 (8%) 6 (12%) Adenoma, Multiple 1 (2%) 1 (2%) Carcinoma 1 (2%) 1 (2%) Bilateral, Adenoma 1 (2%) Bilateral, Carcinoma 1 (2%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (50) (50) (50) Hepatocellular Carcinoma, Metastatic, Liver 1 (2%) Renal Tubule, Adenoma 2 (4%) Renal Tubule, Carcinoma 1 (2%) ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS Multiple Organs *(50) *(50) *(50) *(50) Lymphoma Malignant 3 (6%) 3 (6%) 4 (8%) 2 (4%) ____________________________________________________________________________________________________________________________________ * Number of animals with any tissue examined microscopically Page 11 NTP Experiment-Test: 92013-06 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC 4-METHYLIMIDAZOLE Date: 01/12/04 Route: DOSED FEED Time: 14:34:49 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0 PPM 312 PPM 625 PPM 1250 PPM ____________________________________________________________________________________________________________________________________ TUMOR SUMMARY Total Animals with Primary Neoplasms (b) 34 38 36 39 Total Primary Neoplasms 55 68 57 63 Total Animals with Benign Neoplasms 26 29 23 27 Total Benign Neoplasms 34 38 31 38 Total Animals with Malignant Neoplasms 15 25 21 22 Total Malignant Neoplasms 21 30 26 25 Total Animals with Metastatic Neoplasms 4 3 4 3 Total Metastatic Neoplasm 5 6 6 3 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 ---------- ------------------------------------------------------------