TDMS Study 91005-08 Pathology Tables
NTP Experiment-Test: 91005-08 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC METHYLENE BLUE TRIHYDRATE Date: 04/26/05 Route: GAVAGE Time: 09:25:25 FINAL #1 MICE Facility: Southern Research Institute Chemical CAS #: 7220-79-3 Lock Date: 09/05/03 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: 91005-08 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC METHYLENE BLUE TRIHYDRATE Date: 04/26/05 Route: GAVAGE Time: 09:25:25 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0 MG/KG 2.5 12.5 25 MG/KG MG/KG MG/KG ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially in Study 50 50 50 50 Early Deaths Natural Death 9 5 2 6 Moribund Sacrifice 7 4 5 1 Accidently Killed 1 Dosing Accident 1 1 Survivors Terminal Sacrifice 29 40 41 41 Natural Death 2 1 2 Moribund Sacrifice 2 Animals Examined Microscopically 50 50 50 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Esophagus (50) (50) (50) (50) Fibrosarcoma, Metastatic, Skin 1 (2%) Gallbladder (42) (45) (47) (44) Intestine Large, Cecum (43) (46) (47) (44) Intestine Small, Duodenum (43) (45) (47) (42) Carcinoma 1 (2%) Intestine Small, Jejunum (43) (45) (47) (43) Adenoma 1 (2%) Intestine Small, Ileum (43) (44) (47) (43) Liver (50) (50) (50) (50) Fibrosarcoma, Metastatic, Skin 1 (2%) Hemangiosarcoma 2 (4%) Hepatoblastoma 1 (2%) Hepatocellular Carcinoma 5 (10%) 4 (8%) 3 (6%) Hepatocellular Adenoma 11 (22%) 15 (30%) 13 (26%) 9 (18%) Hepatocellular Adenoma, Multiple 4 (8%) 4 (8%) 9 (18%) 4 (8%) Histiocytic Sarcoma 2 (4%) Serosa, Fibrosarcoma, Metastatic, Skin 1 (2%) Mesentery (18) (14) (15) (13) Fibrosarcoma 1 (8%) Fibrosarcoma, Metastatic, Skin 1 (7%) 1 (7%) 1 (8%) Histiocytic Sarcoma 1 (6%) 1 (8%) Leiomyosarcoma, Metastatic, Uterus 1 (8%) Rhabdomyosarcoma, Metastatic, Skin 1 (7%) Rhabdomyosarcoma, Metastatic, Uncertain Page 2 NTP Experiment-Test: 91005-08 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC METHYLENE BLUE TRIHYDRATE Date: 04/26/05 Route: GAVAGE Time: 09:25:25 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0 MG/KG 2.5 12.5 25 MG/KG MG/KG MG/KG ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - cont Primary Site 1 (6%) Pancreas (46) (46) (49) (49) Fibrosarcoma, Metastatic, Skin 1 (2%) Histiocytic Sarcoma 1 (2%) Salivary Glands (50) (50) (50) (49) Stomach, Forestomach (50) (50) (50) (49) Squamous Cell Papilloma 1 (2%) 1 (2%) 1 (2%) Stomach, Glandular (45) (47) (50) (46) Carcinoma 1 (2%) Tooth (2) (10) (3) (3) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (50) (50) (50) (50) Alveolar/Bronchiolar Carcinoma, Metastatic, Lung 1 (2%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (50) (50) (50) (50) Adenoma 1 (2%) Histiocytic Sarcoma 1 (2%) Capsule, Fibrosarcoma, Metastatic, Skin 1 (2%) Adrenal Medulla (50) (50) (49) (50) Pheochromocytoma Benign 1 (2%) 1 (2%) 2 (4%) Islets, Pancreatic (46) (47) (49) (48) Adenoma 1 (2%) 1 (2%) Carcinoma 1 (2%) Pituitary Gland (46) (49) (48) (47) Pars Distalis, Adenoma 1 (2%) 7 (14%) 5 (10%) 3 (6%) Pars Intermedia, Adenoma 1 (2%) Thyroid Gland (46) (50) (49) (47) Follicular Cell, Adenoma 1 (2%) 1 (2%) 1 (2%) Follicular Cell, Carcinoma 1 (2%) ____________________________________________________________________________________________________________________________________ Page 3 NTP Experiment-Test: 91005-08 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC METHYLENE BLUE TRIHYDRATE Date: 04/26/05 Route: GAVAGE Time: 09:25:25 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0 MG/KG 2.5 12.5 25 MG/KG MG/KG MG/KG ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM Peritoneum (1) Tissue NOS (3) (3) Abdominal, Histiocytic Sarcoma 1 (33%) Thoracic, Histiocytic Sarcoma 1 (33%) ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Clitoral Gland (48) (50) (46) (48) Ovary (47) (48) (49) (48) Alveolar/Bronchiolar Carcinoma, Metastatic, Lung 1 (2%) Cystadenoma 2 (4%) 3 (6%) 3 (6%) 2 (4%) Fibrosarcoma, Metastatic, Skin 1 (2%) Granulosa-Theca Tumor Benign 1 (2%) Hemangiosarcoma 1 (2%) Histiocytic Sarcoma 1 (2%) 1 (2%) Luteoma 1 (2%) Oviduct (1) Uterus (50) (50) (50) (50) Adenoma 1 (2%) 1 (2%) Hemangioma 1 (2%) 1 (2%) Hemangiosarcoma 1 (2%) Histiocytic Sarcoma 1 (2%) Leiomyoma 1 (2%) Leiomyosarcoma 1 (2%) Endometrium, Polyp Stromal 2 (4%) 2 (4%) Vagina (1) Squamous Cell Carcinoma 1 (100%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (50) (50) (49) (50) Hemangiosarcoma 1 (2%) Histiocytic Sarcoma 1 (2%) Lymph Node (7) (5) (10) (10) Iliac, Fibrosarcoma, Metastatic, Skin 1 (20%) Iliac, Histiocytic Sarcoma 1 (14%) Inguinal, Fibrosarcoma, Metastatic, Skin 1 (14%) Inguinal, Histiocytic Sarcoma 1 (14%) Mediastinal, Histiocytic Sarcoma 1 (14%) 1 (10%) Page 4 NTP Experiment-Test: 91005-08 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC METHYLENE BLUE TRIHYDRATE Date: 04/26/05 Route: GAVAGE Time: 09:25:25 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0 MG/KG 2.5 12.5 25 MG/KG MG/KG MG/KG ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - cont Pancreatic, Fibrosarcoma, Metastatic, Skin 1 (20%) Pancreatic, Histiocytic Sarcoma 1 (14%) Pancreatic, Leiomyosarcoma, Metastatic, Uterus 1 (10%) Popliteal, Rhabdomyosarcoma, Metastatic, Skeletal Muscle 1 (10%) Lymph Node, Mandibular (48) (49) (48) (46) Histiocytic Sarcoma 1 (2%) Lymph Node, Mesenteric (46) (49) (49) (48) Histiocytic Sarcoma 1 (2%) 1 (2%) Spleen (47) (47) (49) (50) Hemangiosarcoma 1 (2%) Histiocytic Sarcoma 1 (2%) Thymus (43) (47) (44) (49) Histiocytic Sarcoma 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (50) (50) (50) (50) Carcinoma 2 (4%) 1 (2%) 2 (4%) Skin (50) (50) (50) (50) Basal Cell Carcinoma 1 (2%) Subcutaneous Tissue, Fibrosarcoma 3 (6%) 2 (4%) 2 (4%) 2 (4%) Subcutaneous Tissue, Hemangioma 1 (2%) Subcutaneous Tissue, Hemangiosarcoma 1 (2%) 1 (2%) 2 (4%) Subcutaneous Tissue, Histiocytic Sarcoma 1 (2%) Subcutaneous Tissue, Leiomyosarcoma, Metastatic, Uterus 1 (2%) Subcutaneous Tissue, Lipoma 1 (2%) Subcutaneous Tissue, Rhabdomyosarcoma 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (50) (50) (50) (50) Cranium, Osteosarcoma 1 (2%) Vertebra, Osteosarcoma 1 (2%) Skeletal Muscle (1) (4) (3) (3) Alveolar/Bronchiolar Carcinoma, Metastatic, Lung 1 (100%) Fibrosarcoma, Metastatic, Skin 1 (25%) 1 (33%) 1 (33%) Hemangioma 1 (33%) Page 5 NTP Experiment-Test: 91005-08 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC METHYLENE BLUE TRIHYDRATE Date: 04/26/05 Route: GAVAGE Time: 09:25:25 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0 MG/KG 2.5 12.5 25 MG/KG MG/KG MG/KG ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM - cont Leiomyosarcoma, Metastatic, Uterus 1 (33%) Rhabdomyosarcoma 2 (50%) 2 (67%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (50) (50) (49) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (50) (50) (50) Alveolar/Bronchiolar Adenoma 1 (2%) 2 (4%) 3 (6%) 2 (4%) Alveolar/Bronchiolar Carcinoma 4 (8%) 1 (2%) Alveolar/Bronchiolar Carcinoma, Multiple 1 (2%) Carcinoma, Metastatic, Harderian Gland 1 (2%) Fibrosarcoma, Metastatic, Mesentery 1 (2%) Fibrosarcoma, Metastatic, Skin 1 (2%) 1 (2%) 1 (2%) Hepatocellular Carcinoma, Metastatic, Liver 2 (4%) Histiocytic Sarcoma 1 (2%) 1 (2%) Rhabdomyosarcoma, Metastatic, Skeletal Muscle 1 (2%) Squamous Cell Carcinoma, Metastatic, Vagina 1 (2%) Mediastinum, Alveolar/Bronchiolar Carcinoma, Metastatic, Lung 1 (2%) Mediastinum, Fibrosarcoma, Metastatic, Skin 1 (2%) Mediastinum, Histiocytic Sarcoma 1 (2%) Nose (50) (50) (50) (50) Trachea (49) (50) (50) (49) Carcinoma, Metastatic, Thyroid Gland 1 (2%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (43) (48) (47) (47) Harderian Gland (49) (50) (50) (50) Adenoma 4 (8%) 2 (4%) 7 (14%) 3 (6%) Carcinoma 1 (2%) 2 (4%) 2 (4%) ____________________________________________________________________________________________________________________________________ Page 6 NTP Experiment-Test: 91005-08 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC METHYLENE BLUE TRIHYDRATE Date: 04/26/05 Route: GAVAGE Time: 09:25:25 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0 MG/KG 2.5 12.5 25 MG/KG MG/KG MG/KG ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (48) (50) (49) (50) Histiocytic Sarcoma 1 (2%) Urinary Bladder (45) (47) (49) (48) Hemangiosarcoma 1 (2%) Histiocytic Sarcoma 1 (2%) ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS Multiple Organs *(50) *(50) *(50) *(50) Histiocytic Sarcoma 2 (4%) 1 (2%) Lymphoma Malignant 6 (12%) 4 (8%) 9 (18%) 12 (24%) ____________________________________________________________________________________________________________________________________ * Number of animals with any tissue examined microscopically Page 7 NTP Experiment-Test: 91005-08 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC METHYLENE BLUE TRIHYDRATE Date: 04/26/05 Route: GAVAGE Time: 09:25:25 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0 MG/KG 2.5 12.5 25 MG/KG MG/KG MG/KG ____________________________________________________________________________________________________________________________________ TUMOR SUMMARY Total Animals with Primary Neoplasms (b) 38 36 40 37 Total Primary Neoplasms 60 57 72 57 Total Animals with Benign Neoplasms 25 29 32 22 Total Benign Neoplasms 30 41 48 29 Total Animals with Malignant Neoplasms 25 15 18 24 Total Malignant Neoplasms 30 16 24 28 Total Animals with Metastatic Neoplasms 5 4 5 5 Total Metastatic Neoplasm 8 11 8 11 Total Animals with Malignant Neoplasms 1 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 8 NTP Experiment-Test: 91005-08 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC METHYLENE BLUE TRIHYDRATE Date: 04/26/05 Route: GAVAGE Time: 09:25:25 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0 MG/KG 2.5 12.5 25 MG/KG MG/KG MG/KG ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially in Study 50 50 50 50 Early Deaths Natural Death 11 6 5 3 Moribund Sacrifice 4 4 7 4 Accidently Killed 1 Dosing Accident 1 2 Survivors Terminal Sacrifice 35 38 38 41 Animals Examined Microscopically 50 50 50 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Gallbladder (40) (44) (45) (44) Histiocytic Sarcoma 1 (2%) Intestine Large, Cecum (45) (46) (46) (47) Carcinoma 1 (2%) Intestine Small, Duodenum (42) (46) (46) (46) Adenoma 1 (2%) 2 (4%) Carcinoma 1 (2%) 1 (2%) Histiocytic Sarcoma 1 (2%) Intestine Small, Jejunum (45) (45) (47) (47) Adenoma 1 (2%) 1 (2%) 1 (2%) Carcinoma 2 (4%) 2 (4%) Hepatocholangiocarcinoma, Metastatic, Liver 1 (2%) Histiocytic Sarcoma 1 (2%) Intestine Small, Ileum (43) (45) (44) (47) Carcinoma 1 (2%) Liver (50) (50) (50) (49) Carcinoma, Metastatic, Pancreas 1 (2%) Cholangiocarcinoma 1 (2%) Hemangiosarcoma 2 (4%) 5 (10%) 3 (6%) 1 (2%) Hepatoblastoma 2 (4%) 2 (4%) 2 (4%) Hepatocellular Carcinoma 11 (22%) 9 (18%) 8 (16%) 11 (22%) Hepatocellular Carcinoma, Multiple 2 (4%) 1 (2%) 3 (6%) 3 (6%) Hepatocellular Adenoma 14 (28%) 20 (40%) 14 (28%) 14 (29%) Hepatocellular Adenoma, Multiple 14 (28%) 13 (26%) 12 (24%) 13 (27%) Hepatocholangiocarcinoma 1 (2%) Histiocytic Sarcoma 2 (4%) Mesentery (5) (11) (5) (4) Page 9 NTP Experiment-Test: 91005-08 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC METHYLENE BLUE TRIHYDRATE Date: 04/26/05 Route: GAVAGE Time: 09:25:25 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0 MG/KG 2.5 12.5 25 MG/KG MG/KG MG/KG ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - cont Carcinoma, Metastatic, Pancreas 1 (25%) Hemangiosarcoma 2 (18%) Hepatocellular Carcinoma, Metastatic, Liver 1 (20%) Hepatocholangiocarcinoma, Metastatic, Liver 1 (9%) Histiocytic Sarcoma 1 (20%) Pancreas (48) (50) (49) (48) Hepatocholangiocarcinoma, Metastatic, Liver 1 (2%) Acinus, Carcinoma 1 (2%) Stomach, Forestomach (50) (50) (50) (48) Squamous Cell Papilloma 1 (2%) 2 (4%) 2 (4%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (50) (50) (50) (50) Hepatocholangiocarcinoma, Metastatic, Liver 1 (2%) Histiocytic Sarcoma 1 (2%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (48) (50) (50) (48) Adenoma 1 (2%) Histiocytic Sarcoma 1 (2%) Subcapsular, Adenoma 5 (10%) 4 (8%) 2 (4%) 5 (10%) Adrenal Medulla (48) (50) (50) (48) Histiocytic Sarcoma 1 (2%) Pheochromocytoma Benign 1 (2%) 2 (4%) Islets, Pancreatic (50) (50) (49) (48) Adenoma 2 (4%) 2 (4%) 1 (2%) Histiocytic Sarcoma 1 (2%) Thyroid Gland (50) (50) (49) (48) Follicular Cell, Adenoma 3 (6%) 1 (2%) 3 (6%) 1 (2%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM Peritoneum (1) Histiocytic Sarcoma 1 (100%) ____________________________________________________________________________________________________________________________________ Page 10 NTP Experiment-Test: 91005-08 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC METHYLENE BLUE TRIHYDRATE Date: 04/26/05 Route: GAVAGE Time: 09:25:25 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0 MG/KG 2.5 12.5 25 MG/KG MG/KG MG/KG ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Coagulating Gland (1) Epididymis (50) (50) (49) (49) Carcinoma, Metastatic, Pancreas 1 (2%) Seminal Vesicle (49) (50) (50) (49) Carcinoma 1 (2%) Testes (50) (50) (50) (50) Interstitial Cell, Adenoma 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (50) (50) (50) (50) Hemangiosarcoma 1 (2%) 2 (4%) Histiocytic Sarcoma 1 (2%) Lymph Node (5) (3) (3) (6) Bronchial, Carcinoma, Metastatic, Pancreas 1 (17%) Iliac, Histiocytic Sarcoma 1 (33%) Mediastinal, Carcinoma, Metastatic, Harderian Gland 1 (20%) Mediastinal, Carcinoma, Metastatic, Pancreas 1 (17%) Mediastinal, Histiocytic Sarcoma 1 (33%) Pancreatic, Histiocytic Sarcoma 1 (33%) Renal, Histiocytic Sarcoma 1 (33%) Lymph Node, Mandibular (43) (46) (48) (47) Carcinoma, Metastatic, Harderian Gland 1 (2%) Lymph Node, Mesenteric (47) (50) (48) (48) Hepatocholangiocarcinoma, Metastatic, Liver 1 (2%) Histiocytic Sarcoma 2 (4%) Spleen (49) (50) (49) (48) Hemangioma 1 (2%) Hemangiosarcoma 2 (4%) 4 (8%) 1 (2%) 1 (2%) Histiocytic Sarcoma 2 (4%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Skin (50) (50) (50) (50) Fibroma 1 (2%) Squamous Cell Papilloma 1 (2%) Subcutaneous Tissue, Hemangiosarcoma 1 (2%) 1 (2%) 1 (2%) Subcutaneous Tissue, Histiocytic Sarcoma 1 (2%) Subcutaneous Tissue, Sarcoma 1 (2%) Page 11 NTP Experiment-Test: 91005-08 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC METHYLENE BLUE TRIHYDRATE Date: 04/26/05 Route: GAVAGE Time: 09:25:25 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0 MG/KG 2.5 12.5 25 MG/KG MG/KG MG/KG ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM - cont Subcutaneous Tissue, Schwannoma Malignant 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (50) (50) (50) (50) Hepatocholangiocarcinoma, Metastatic, Liver 1 (2%) Osteoma 1 (2%) Osteosarcoma 1 (2%) Cranium, Carcinoma, Metastatic, Harderian Gland 1 (2%) Vertebra, Hemangiosarcoma 1 (2%) Skeletal Muscle (4) (1) (1) Carcinoma, Metastatic, Intestine Small, Ileum 1 (100%) Hemangiosarcoma, Multiple 1 (25%) Hepatocholangiocarcinoma, Metastatic, Liver 1 (25%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM None ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (50) (50) (50) Alveolar/Bronchiolar Adenoma 9 (18%) 5 (10%) 8 (16%) 4 (8%) Alveolar/Bronchiolar Adenoma, Multiple 2 (4%) 2 (4%) 2 (4%) Alveolar/Bronchiolar Carcinoma 1 (2%) 4 (8%) 4 (8%) 6 (12%) Alveolar/Bronchiolar Carcinoma, Multiple 1 (2%) 1 (2%) Carcinoma, Metastatic, Harderian Gland 1 (2%) Carcinoma, Metastatic, Pancreas 1 (2%) Carcinoma, Metastatic, Intestine Small, Ileum 1 (2%) Hepatoblastoma, Metastatic, Liver 1 (2%) 1 (2%) Hepatocellular Carcinoma, Metastatic, Liver 3 (6%) 4 (8%) 3 (6%) 4 (8%) Hepatocholangiocarcinoma, Metastatic, Liver 1 (2%) Histiocytic Sarcoma 1 (2%) Sarcoma, Metastatic, Skin 1 (2%) Mediastinum, Hepatoblastoma, Metastatic, Liver 1 (2%) Mediastinum, Hepatocholangiocarcinoma, Metastatic, Liver 1 (2%) Mediastinum, Histiocytic Sarcoma 1 (2%) Page 12 NTP Experiment-Test: 91005-08 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC METHYLENE BLUE TRIHYDRATE Date: 04/26/05 Route: GAVAGE Time: 09:25:25 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0 MG/KG 2.5 12.5 25 MG/KG MG/KG MG/KG ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM - cont Nose (50) (50) (50) (50) Carcinoma, Metastatic, Harderian Gland 1 (2%) Sarcoma, Metastatic, Skin 1 (2%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (45) (49) (49) (47) Carcinoma, Metastatic, Harderian Gland 1 (2%) Sarcoma, Metastatic, Skin 1 (2%) Harderian Gland (50) (50) (50) (50) Adenoma 7 (14%) 1 (2%) 11 (22%) 5 (10%) Carcinoma 2 (4%) 4 (8%) 1 (2%) Sarcoma, Metastatic, Skin 1 (2%) Bilateral, Adenoma 1 (2%) Bilateral, Carcinoma 1 (2%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (49) (49) (50) (48) Hepatocholangiocarcinoma, Metastatic, Liver 1 (2%) Histiocytic Sarcoma 2 (4%) Renal Tubule, Adenoma 1 (2%) 1 (2%) Renal Tubule, Carcinoma 1 (2%) Urinary Bladder (48) (50) (50) (48) Hemangiosarcoma 1 (2%) ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS Multiple Organs *(50) *(50) *(50) *(50) Histiocytic Sarcoma 3 (6%) Lymphoma Malignant 2 (4%) 2 (4%) 2 (4%) 5 (10%) ____________________________________________________________________________________________________________________________________ * Number of animals with any tissue examined microscopically Page 13 NTP Experiment-Test: 91005-08 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC METHYLENE BLUE TRIHYDRATE Date: 04/26/05 Route: GAVAGE Time: 09:25:25 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0 MG/KG 2.5 12.5 25 MG/KG MG/KG MG/KG ____________________________________________________________________________________________________________________________________ TUMOR SUMMARY Total Animals with Primary Neoplasms (b) 46 47 46 47 Total Primary Neoplasms 87 90 96 89 Total Animals with Benign Neoplasms 37 38 39 35 Total Benign Neoplasms 56 53 61 53 Total Animals with Malignant Neoplasms 26 23 25 26 Total Malignant Neoplasms 31 37 35 36 Total Animals with Metastatic Neoplasms 5 6 5 6 Total Metastatic Neoplasm 11 16 7 12 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 14 ------------------------------------------------------------ ---------- END OF REPORT ---------- ------------------------------------------------------------