TDMS Study 91005-07 Pathology Tables
NTP Experiment-Test: 91005-07 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC METHYLENE BLUE TRIHYDRATE Date: 03/25/05
Route: GAVAGE Time: 10:08:31
FINAL #1 RATS
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: 91005-07 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC METHYLENE BLUE TRIHYDRATE Date: 03/25/05
Route: GAVAGE Time: 10:08:31
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 MG/KG 5 MG/KG 25 MG/KG 50 MG/KG
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially in Study 50 50 50 50
Early Deaths
Natural Death 6 4 9 11
Moribund Sacrifice 9 13 5 3
Dosing Accident 1
Survivors
Terminal Sacrifice 35 32 34 35
Natural Death 2
Other 1
Animals Examined Microscopically 50 49 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Liver (50) (49) (50) (50)
Granulosa Cell Tumor Malignant, Metastatic,
Ovary 1 (2%)
Mesentery (17) (14) (12) (8)
Granulosa Cell Tumor Malignant, Metastatic,
Ovary 1 (8%)
Oral Mucosa (2) (1)
Pharyngeal, Squamous Cell Carcinoma 1 (50%)
Pancreas (49) (48) (48) (49)
Acinus, Adenoma 1 (2%)
Salivary Glands (50) (49) (50) (50)
Schwannoma Malignant 1 (2%)
Stomach, Forestomach (50) (49) (49) (49)
Squamous Cell Papilloma 1 (2%)
Tongue (1) (1) (1) (1)
Squamous Cell Papilloma 1 (100%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (50) (49) (50) (50)
Schwannoma Benign 1 (2%)
____________________________________________________________________________________________________________________________________
Page 2
NTP Experiment-Test: 91005-07 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC METHYLENE BLUE TRIHYDRATE Date: 03/25/05
Route: GAVAGE Time: 10:08:31
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 MG/KG 5 MG/KG 25 MG/KG 50 MG/KG
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (50) (49) (50) (50)
Adenoma 1 (2%)
Adrenal Medulla (50) (49) (50) (50)
Pheochromocytoma Complex 1 (2%)
Pheochromocytoma Benign 2 (4%) 1 (2%) 1 (2%)
Islets, Pancreatic (49) (48) (48) (49)
Adenoma 2 (4%) 1 (2%) 1 (2%)
Pituitary Gland (50) (49) (50) (50)
Pars Distalis, Adenoma 36 (72%) 32 (65%) 31 (62%) 28 (56%)
Thyroid Gland (50) (49) (50) (50)
Bilateral, C-Cell, Adenoma 1 (2%) 2 (4%)
C-Cell, Adenoma 6 (12%) 5 (10%) 8 (16%) 1 (2%)
C-Cell, Carcinoma 1 (2%)
Follicular Cell, Adenoma 1 (2%)
Follicular Cell, Carcinoma 1 (2%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Clitoral Gland (50) (48) (50) (50)
Adenoma 7 (14%) 10 (21%) 8 (16%) 9 (18%)
Carcinoma 1 (2%) 1 (2%) 1 (2%) 1 (2%)
Ovary (50) (49) (50) (50)
Granulosa Cell Tumor Malignant 1 (2%)
Uterus (50) (49) (50) (50)
Adenoma 1 (2%)
Polyp Stromal 13 (26%) 14 (29%) 13 (26%) 7 (14%)
Sarcoma Stromal 2 (4%) 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (50) (49) (50) (50)
Histiocytic Sarcoma 1 (2%)
Lymph Node (15) (8) (11) (3)
Lymph Node, Mesenteric (49) (49) (50) (50)
Spleen (49) (48) (49) (49)
Page 3
NTP Experiment-Test: 91005-07 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC METHYLENE BLUE TRIHYDRATE Date: 03/25/05
Route: GAVAGE Time: 10:08:31
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 MG/KG 5 MG/KG 25 MG/KG 50 MG/KG
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - cont
Granulosa Cell Tumor Malignant, Metastatic,
Ovary 1 (2%)
Histiocytic Sarcoma 1 (2%)
Thymus (50) (49) (50) (50)
Thymoma Benign 1 (2%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (50) (49) (50) (50)
Adenoma 1 (2%) 2 (4%)
Carcinoma 1 (2%)
Fibroadenoma 20 (40%) 17 (35%) 22 (44%) 13 (26%)
Fibroadenoma, Multiple 8 (16%) 13 (27%) 6 (12%) 4 (8%)
Skin (50) (49) (50) (50)
Basal Cell Carcinoma 1 (2%)
Squamous Cell Papilloma 1 (2%) 1 (2%)
Trichoepithelioma 1 (2%) 1 (2%)
Pinna, Neural Crest Tumor 1 (2%)
Subcutaneous Tissue, Fibroma 1 (2%) 1 (2%) 2 (4%)
Subcutaneous Tissue, Fibrosarcoma 1 (2%) 3 (6%)
Subcutaneous Tissue, Hemangiosarcoma 1 (2%)
Subcutaneous Tissue, Lipoma 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (50) (49) (50) (50)
Osteosarcoma 1 (2%)
Vertebra, Chordoma 1 (2%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (49) (50) (50)
Astrocytoma Malignant 1 (2%)
Peripheral Nerve (3) (4) (4) (2)
Schwannoma Malignant 1 (25%)
____________________________________________________________________________________________________________________________________
Page 4
NTP Experiment-Test: 91005-07 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC METHYLENE BLUE TRIHYDRATE Date: 03/25/05
Route: GAVAGE Time: 10:08:31
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 MG/KG 5 MG/KG 25 MG/KG 50 MG/KG
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (49) (50) (50)
Alveolar/Bronchiolar Adenoma 1 (2%) 1 (2%)
Chordoma, Metastatic, Bone 1 (2%)
Pheochromocytoma Complex, Metastatic,
Adrenal Medulla 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (50) (49) (50) (50)
Harderian Gland (50) (49) (50) (50)
Zymbal's Gland (1) (1)
Carcinoma 1 (100%) 1 (100%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (49) (50) (50)
Renal Tubule, Adenoma 1 (2%)
Urinary Bladder (50) (49) (50) (50)
Transitional Epithelium, Papilloma 1 (2%)
____________________________________________________________________________________________________________________________________
SYSTEMIC LESIONS
Multiple Organs *(50) *(49) *(50) *(50)
Histiocytic Sarcoma 1 (2%) 1 (2%)
Leukemia Mononuclear 12 (24%) 6 (12%) 3 (6%) 2 (4%)
____________________________________________________________________________________________________________________________________
* Number of animals with any tissue examined microscopically
Page 5
NTP Experiment-Test: 91005-07 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC METHYLENE BLUE TRIHYDRATE Date: 03/25/05
Route: GAVAGE Time: 10:08:31
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 MG/KG 5 MG/KG 25 MG/KG 50 MG/KG
____________________________________________________________________________________________________________________________________
TUMOR SUMMARY
Total Animals with Primary Neoplasms (b) 50 48 46 40
Total Primary Neoplasms 125 114 107 74
Total Animals with Benign Neoplasms 47 45 45 40
Total Benign Neoplasms 103 98 98 68
Total Animals with Malignant Neoplasms 19 16 8 5
Total Malignant Neoplasms 22 16 9 5
Total Animals with Metastatic Neoplasms 1 1 1
Total Metastatic Neoplasm 1 3 1
Total Animals with Malignant Neoplasms
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
Page 6
NTP Experiment-Test: 91005-07 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC METHYLENE BLUE TRIHYDRATE Date: 03/25/05
Route: GAVAGE Time: 10:08:31
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 MG/KG 5 MG/KG 25 MG/KG 50 MG/KG
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially in Study 50 50 50 50
Early Deaths
Natural Death 6 10 5 7
Moribund Sacrifice 13 7 5 10
Dosing Accident 1 2
Survivors
Natural Death 1
Terminal Sacrifice 29 33 39 30
Moribund Sacrifice 1 1
Animals Examined Microscopically 50 50 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Intestine Small, Duodenum (50) (50) (50) (48)
Schwannoma Malignant 1 (2%)
Intestine Small, Jejunum (47) (47) (47) (48)
Intestine Small, Ileum (48) (50) (49) (48)
Liver (50) (50) (50) (50)
Hemangiosarcoma 1 (2%)
Hepatocellular Carcinoma 1 (2%)
Hepatocellular Adenoma 1 (2%) 1 (2%)
Mesentery (16) (11) (9) (12)
Carcinoma, Metastatic, Zymbal's Gland 1 (8%)
Fibrous Histiocytoma, Metastatic, Skin 1 (8%)
Hemangiosarcoma 1 (6%)
Oral Mucosa (1) (4)
Pharyngeal, Squamous Cell Carcinoma 1 (100%) 1 (25%)
Pancreas (50) (50) (50) (50)
Carcinoma, Metastatic, Zymbal's Gland 1 (2%)
Mixed Tumor Benign 1 (2%) 1 (2%) 1 (2%)
Acinus, Adenoma 2 (4%) 4 (8%) 3 (6%)
Stomach, Forestomach (50) (50) (50) (50)
Stomach, Glandular (50) (50) (50) (50)
____________________________________________________________________________________________________________________________________
Page 7
NTP Experiment-Test: 91005-07 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC METHYLENE BLUE TRIHYDRATE Date: 03/25/05
Route: GAVAGE Time: 10:08:31
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 MG/KG 5 MG/KG 25 MG/KG 50 MG/KG
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (50) (50) (50) (50)
Carcinoma, Metastatic, Zymbal's Gland 1 (2%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (50) (50) (50) (50)
Adenoma 1 (2%) 1 (2%) 2 (4%)
Osteosarcoma, Metastatic, Nose 1 (2%)
Adrenal Medulla (50) (50) (50) (50)
Pheochromocytoma Malignant 1 (2%) 1 (2%)
Pheochromocytoma Complex 1 (2%)
Pheochromocytoma Benign 7 (14%) 12 (24%) 2 (4%) 2 (4%)
Bilateral, Pheochromocytoma Benign 2 (4%) 1 (2%) 1 (2%)
Islets, Pancreatic (50) (50) (50) (50)
Adenoma 4 (8%) 8 (16%) 12 (24%) 7 (14%)
Adenoma, Multiple 1 (2%) 1 (2%)
Carcinoma 2 (4%)
Pituitary Gland (50) (50) (50) (50)
Pars Distalis, Adenoma 25 (50%) 32 (64%) 26 (52%) 21 (42%)
Pars Distalis, Carcinoma 1 (2%)
Thyroid Gland (50) (50) (50) (50)
Bilateral, C-Cell, Adenoma 2 (4%) 1 (2%)
C-Cell, Adenoma 4 (8%) 3 (6%) 6 (12%) 4 (8%)
C-Cell, Carcinoma 2 (4%) 2 (4%)
Follicular Cell, Adenoma 2 (4%) 2 (4%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
Peritoneum (1) (1) (1) (2)
Carcinoma, Metastatic, Zymbal's Gland 1 (50%)
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Epididymis (50) (50) (50) (50)
Preputial Gland (50) (50) (50) (50)
Adenoma 1 (2%) 4 (8%) 5 (10%)
Bilateral, Adenoma 1 (2%)
Prostate (50) (50) (50) (50)
Adenoma 1 (2%)
Page 8
NTP Experiment-Test: 91005-07 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC METHYLENE BLUE TRIHYDRATE Date: 03/25/05
Route: GAVAGE Time: 10:08:31
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 MG/KG 5 MG/KG 25 MG/KG 50 MG/KG
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM - cont
Carcinoma, Metastatic, Zymbal's Gland 1 (2%)
Seminal Vesicle (50) (50) (50) (50)
Testes (50) (50) (50) (50)
Bilateral, Interstitial Cell, Adenoma 32 (64%) 28 (56%) 31 (62%) 31 (62%)
Interstitial Cell, Adenoma 9 (18%) 11 (22%) 14 (28%) 3 (6%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (50) (50) (50) (50)
Lymph Node (21) (17) (10) (18)
Mediastinal, Carcinoma, Metastatic,
Harderian Gland 1 (6%)
Pancreatic, Carcinoma, Metastatic, Zymbal's
Gland 1 (6%)
Lymph Node, Mesenteric (50) (50) (50) (50)
Carcinoma, Metastatic, Zymbal's Gland 1 (2%)
Spleen (50) (50) (50) (50)
Carcinoma, Metastatic, Zymbal's Gland 1 (2%)
Hemangiosarcoma 1 (2%) 1 (2%) 1 (2%)
Thymus (49) (50) (50) (50)
Carcinoma, Metastatic, Zymbal's Gland 1 (2%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (50) (50) (50) (50)
Fibroadenoma 2 (4%) 3 (6%) 1 (2%) 1 (2%)
Skin (50) (50) (50) (50)
Basal Cell Adenoma 2 (4%) 1 (2%)
Keratoacanthoma 3 (6%) 1 (2%) 3 (6%)
Squamous Cell Carcinoma 2 (4%)
Squamous Cell Papilloma 3 (6%) 2 (4%) 5 (10%)
Squamous Cell Papilloma, Multiple 1 (2%) 1 (2%)
Lip, Fibrosarcoma 1 (2%)
Pinna, Neural Crest Tumor 1 (2%)
Sebaceous Gland, Adenoma 1 (2%)
Subcutaneous Tissue, Fibroma 5 (10%) 4 (8%) 1 (2%) 1 (2%)
Subcutaneous Tissue, Fibroma, Multiple 1 (2%)
Subcutaneous Tissue, Fibrosarcoma 2 (4%) 2 (4%)
Subcutaneous Tissue, Fibrous Histiocytoma 1 (2%)
Subcutaneous Tissue, Hemangiosarcoma 1 (2%)
Subcutaneous Tissue, Lipoma 1 (2%)
Page 9
NTP Experiment-Test: 91005-07 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC METHYLENE BLUE TRIHYDRATE Date: 03/25/05
Route: GAVAGE Time: 10:08:31
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 MG/KG 5 MG/KG 25 MG/KG 50 MG/KG
____________________________________________________________________________________________________________________________________
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (50) (50) (50) (50)
Osteosarcoma 1 (2%) 1 (2%)
Skeletal Muscle (3) (1) (4)
Carcinoma, Metastatic, Zymbal's Gland 1 (25%)
Hemangioma 1 (33%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (50) (50) (50)
Carcinoma, Metastatic, Pituitary Gland 1 (2%)
Glioma Malignant 1 (2%)
Peripheral Nerve (6) (3) (4) (6)
Schwannoma Benign 1 (33%)
Schwannoma Malignant 1 (17%) 1 (25%)
Trigeminal, Squamous Cell Carcinoma,
Metastatic, Oral Mucosa 1 (17%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (50) (50) (50)
Alveolar/Bronchiolar Adenoma 1 (2%) 1 (2%) 2 (4%)
Alveolar/Bronchiolar Carcinoma 2 (4%)
Carcinoma, Metastatic, Thyroid Gland 1 (2%)
Carcinoma, Metastatic, Zymbal's Gland 1 (2%)
Fibrous Histiocytoma, Metastatic, Skin 1 (2%)
Osteosarcoma, Metastatic, Nose 1 (2%)
Pheochromocytoma Malignant, Metastatic,
Adrenal Medulla 1 (2%)
Schwannoma Malignant, Metastatic, Peripheral
Nerve 1 (2%)
Squamous Cell Carcinoma, Metastatic, Skin 1 (2%)
Nose (50) (50) (50) (50)
Carcinoma, Metastatic, Harderian Gland 1 (2%)
Osteosarcoma 1 (2%)
____________________________________________________________________________________________________________________________________
Page 10
NTP Experiment-Test: 91005-07 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC METHYLENE BLUE TRIHYDRATE Date: 03/25/05
Route: GAVAGE Time: 10:08:31
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 MG/KG 5 MG/KG 25 MG/KG 50 MG/KG
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Harderian Gland (50) (50) (50) (50)
Adenoma 1 (2%)
Carcinoma 1 (2%)
Zymbal's Gland (1) (1) (1)
Adenoma 1 (100%)
Carcinoma 1 (100%) 1 (100%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (50) (50) (50)
Carcinoma, Metastatic, Zymbal's Gland 1 (2%)
Renal Tubule, Adenoma 1 (2%)
Urinary Bladder (50) (50) (50) (49)
Papilloma 1 (2%)
____________________________________________________________________________________________________________________________________
SYSTEMIC LESIONS
Multiple Organs *(50) *(50) *(50) *(50)
Leukemia Mononuclear 23 (46%) 10 (20%) 2 (4%) 2 (4%)
Mesothelioma Malignant 3 (6%) 5 (10%) 2 (4%) 3 (6%)
____________________________________________________________________________________________________________________________________
* Number of animals with any tissue examined microscopically
Page 11
NTP Experiment-Test: 91005-07 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC METHYLENE BLUE TRIHYDRATE Date: 03/25/05
Route: GAVAGE Time: 10:08:31
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 MG/KG 5 MG/KG 25 MG/KG 50 MG/KG
____________________________________________________________________________________________________________________________________
TUMOR SUMMARY
Total Animals with Primary Neoplasms (b) 49 50 50 48
Total Primary Neoplasms 146 141 135 98
Total Animals with Benign Neoplasms 47 50 50 48
Total Benign Neoplasms 107 117 121 85
Total Animals with Malignant Neoplasms 30 19 12 12
Total Malignant Neoplasms 38 24 14 13
Total Animals with Metastatic Neoplasms 3 2 2 3
Total Metastatic Neoplasm 3 3 2 16
Total Animals with Malignant Neoplasms
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
Page 12
------------------------------------------------------------
---------- END OF REPORT ----------
------------------------------------------------------------