TDMS Study 91005-08 Pathology Tables
NTP Experiment-Test: 91005-08 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 06/02/05
Route: GAVAGE METHYLENE BLUE TRIHYDRATE Time: 13:15:53
FINAL #1; REVISION #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
b Average severity grade (1-minimal;2-mild;3-moderate;4-marked)
Page 1
NTP Experiment-Test: 91005-08 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 06/02/05
Route: GAVAGE METHYLENE BLUE TRIHYDRATE Time: 13:15:53
____________________________________________________________________________________________________________________________________
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)
Foreign Body 1 [3.0]
Inflammation 1 [3.0]
Perforation 1 [3.0]
Gallbladder (42) (45) (47) (44)
Cyst 2 1 2
Intestine Large, Rectum (48) (48) (50) (46)
Artery, Inflammation, Chronic, Focal 1 [3.0]
Intestine Large, Cecum (43) (46) (47) (44)
Edema 1 [3.0]
Lymphoid Tissue, Hyperplasia, Lymphoid 1 [3.0]
Intestine Small, Duodenum (43) (45) (47) (42)
Epithelium, Hyperplasia, Focal 1 [2.0]
Intestine Small, Jejunum (43) (45) (47) (43)
Epithelium, Hyperplasia, Focal 1 [2.0]
Lymphoid Tissue, Hyperplasia 1 [4.0]
Liver (50) (50) (50) (50)
Angiectasis, Focal 2 [2.0]
Basophilic Focus 1 3
Clear Cell Focus 3 3 4 2
Congestion 1 [3.0] 2 [2.5] 1 [1.0] 1 [3.0]
Eosinophilic Focus 1 1 3 1
Fibrosis, Focal 1 [1.0]
Hematopoietic Cell Proliferation 4 [1.3] 1 [2.0] 6 [1.7] 2 [1.0]
Hemorrhage 1 [3.0] 1 [1.0]
Hepatodiaphragmatic Nodule 1 [2.0]
a Number of animals examined microscopically at site and number of animals with lesion
b Average severity grade (1-minimal;2-mild;3-moderate;4-marked)
Page 2
NTP Experiment-Test: 91005-08 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 06/02/05
Route: GAVAGE METHYLENE BLUE TRIHYDRATE Time: 13:15:53
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 MG/KG 2.5 12.5 25
MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Infarct 1 [3.0]
Infiltration Cellular, Mixed Cell 11 [1.5] 12 [1.2] 12 [1.5] 15 [1.1]
Mixed Cell Focus 2 1 1
Bile Duct, Cyst 1
Hepatocyte, Necrosis, Focal 3 [1.7] 3 [1.7] 1 [2.0]
Hepatocyte, Vacuolization Cytoplasmic 12 [2.7] 11 [2.0] 8 [2.3] 15 [2.3]
Kupffer Cell, Pigmentation 1 [1.0] 1 [1.0]
Mesentery (18) (14) (15) (13)
Hemorrhage 1 [3.0] 1 [2.0]
Infiltration Cellular, Lymphoid 1 [2.0]
Artery, Inflammation, Chronic, Focal 1 [3.0] 1 [3.0] 1 [3.0]
Fat, Necrosis, Focal 16 [2.4] 12 [2.8] 13 [2.3] 4 [2.5]
Pancreas (46) (46) (49) (49)
Acinus, Atrophy, Diffuse 1 [4.0]
Acinus, Atrophy, Focal 1 [4.0] 1 [4.0] 1 [1.0]
Acinus, Cytoplasmic Alteration 1 [1.0]
Duct, Cyst 2 2 2
Salivary Glands (50) (50) (50) (49)
Hyperplasia, Lymphoid 1 [3.0]
Stomach, Forestomach (50) (50) (50) (49)
Diverticulum 1 [1.0] 1 [1.0] 3 [1.0]
Inflammation, Focal 1 [1.0] 1 [3.0]
Ulcer 2 [2.0] 3 [2.0] 1 [1.0]
Epithelium, Hyperplasia 2 [2.0] 2 [2.0] 2 [2.5] 1 [2.0]
Stomach, Glandular (45) (47) (50) (46)
Cyst 1 1
Epithelium, Cytoplasmic Alteration, Focal 1 [2.0]
Epithelium, Hyperplasia 1 [2.0]
Tooth (2) (10) (3) (3)
Dysplasia 2 [1.5] 10 [1.2] 3 [1.3] 3 [1.3]
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Blood Vessel (1)
Aneurysm 1 [4.0]
Heart (50) (50) (50) (50)
Cardiomyopathy 1 [1.0] 1 [1.0]
Infiltration Cellular, Mixed Cell 1 [3.0]
Mineralization, Focal 1 [1.0]
Thrombosis 1 [3.0]
Artery, Inflammation, Chronic 1 [3.0]
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
b Average severity grade (1-minimal;2-mild;3-moderate;4-marked)
Page 3
NTP Experiment-Test: 91005-08 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 06/02/05
Route: GAVAGE METHYLENE BLUE TRIHYDRATE Time: 13:15:53
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 MG/KG 2.5 12.5 25
MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (50) (50) (50) (50)
Accessory Adrenal Cortical Nodule 2 [2.0] 2 [1.5]
Angiectasis 1 [2.0]
Cytoplasmic Alteration, Focal 1 [1.0]
Degeneration, Cystic 1 [1.0]
Hyperplasia, Focal 1 [2.0]
Infiltration Cellular, Mixed Cell 1 [2.0]
Adrenal Medulla (50) (50) (49) (50)
Hyperplasia, Focal 1 [1.0]
Parathyroid Gland (48) (48) (46) (49)
Cyst 1 1 1 1
Pituitary Gland (46) (49) (48) (47)
Angiectasis 2 [1.0] 1 [1.0]
Cyst 1 1
Pars Distalis, Cytoplasmic Alteration, Focal 1 [1.0] 4 [1.5] 1 [2.0] 2 [2.0]
Pars Distalis, Hyperplasia, Focal 1 [1.0] 1 [2.0] 1 [2.0] 1 [2.0]
Thyroid Gland (46) (50) (49) (47)
Cyst 1 1
Inflammation, Chronic, Focal 1 [2.0] 1 [2.0] 1 [2.0]
C-Cell, Hyperplasia 1 [2.0] 1 [2.0]
Follicle, Degeneration, Cystic, Focal 17 [1.8] 15 [1.5] 28 [1.6] 23 [1.7]
Follicular Cell, Hyperplasia, Focal 5 [1.6] 2 [2.0] 4 [2.0] 5 [1.4]
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
Tissue NOS (3) (3)
Pelvic, Fibrosis 1 [3.0]
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Clitoral Gland (48) (50) (46) (48)
Degeneration, Cystic 1 [2.0] 1 [2.0]
Ovary (47) (48) (49) (48)
Angiectasis 3 [3.3] 2 [3.0] 2 [2.5]
Cyst 11 12 16 13
Hemorrhage 1 [3.0] 1 [3.0]
Pigmentation, Focal 1 [3.0]
Thrombosis 3 [4.0] 3 [3.3]
Bilateral, Cyst 1
a Number of animals examined microscopically at site and number of animals with lesion
b Average severity grade (1-minimal;2-mild;3-moderate;4-marked)
Page 4
NTP Experiment-Test: 91005-08 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 06/02/05
Route: GAVAGE METHYLENE BLUE TRIHYDRATE Time: 13:15:53
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 MG/KG 2.5 12.5 25
MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM - CONT
Interstitial Cell, Hyperplasia 1 [3.0]
Uterus (50) (50) (50) (50)
Angiectasis 1 [3.0] 1 [3.0] 1 [3.0]
Hemorrhage 1 [3.0]
Inflammation, Chronic 1 [3.0]
Inflammation, Suppurative 1 [3.0]
Endometrium, Hyperplasia, Cystic 48 [2.8] 45 [2.7] 49 [2.8] 48 [2.8]
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (50) (50) (49) (50)
Hyperplasia 10 [2.7] 4 [2.0] 9 [2.3] 4 [2.5]
Lymph Node (7) (5) (10) (10)
Iliac, Angiectasis 1 [3.0]
Iliac, Hyperplasia, Lymphoid 1 [2.0] 2 [2.5] 2 [2.5]
Mediastinal, Hyperplasia, Lymphoid 2 [3.0] 1 [3.0]
Mediastinal, Inflammation 1 [3.0]
Pancreatic, Hyperplasia, Lymphoid 1 [3.0] 1 [3.0] 1 [3.0]
Renal, Hyperplasia, Lymphoid 1 [2.0] 1 [3.0] 1 [3.0]
Lymph Node, Mandibular (48) (49) (48) (46)
Hemorrhage 1 [3.0]
Hyperplasia, Lymphoid 9 [2.0] 11 [2.6] 12 [2.3] 16 [2.2]
Hyperplasia, Mast Cell 1 [3.0]
Lymph Node, Mesenteric (46) (49) (49) (48)
Ectasia 1 [3.0] 2 [3.0]
Hemorrhage 1 [3.0] 2 [3.0] 2 [3.0] 1 [3.0]
Hyperplasia, Histiocytic 1 [3.0]
Hyperplasia, Lymphoid 6 [2.3] 7 [2.3] 10 [2.6] 8 [2.3]
Spleen (47) (47) (49) (50)
Angiectasis, Focal 1 [3.0]
Congestion 2 [3.0]
Fibrosis, Focal 1 [3.0] 1 [3.0]
Hematopoietic Cell Proliferation 23 [2.7] 21 [2.5] 31 [2.4] 40 [2.3]
Hyperplasia, Lymphoid 17 [2.5] 15 [2.3] 17 [2.2] 11 [2.5]
Thymus (43) (47) (44) (49)
Hyperplasia, Lymphoid 8 [2.5] 13 [2.2] 11 [2.5] 14 [2.1]
Inflammation 1 [3.0]
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Skin (50) (50) (50) (50)
a Number of animals examined microscopically at site and number of animals with lesion
b Average severity grade (1-minimal;2-mild;3-moderate;4-marked)
Page 5
NTP Experiment-Test: 91005-08 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 06/02/05
Route: GAVAGE METHYLENE BLUE TRIHYDRATE Time: 13:15:53
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 MG/KG 2.5 12.5 25
MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM - CONT
Subcutaneous Tissue, Edema 1 [3.0]
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (50) (50) (50) (50)
Hyperostosis 5 [1.6] 5 [1.4] 4 [1.8] 5 [2.2]
Vertebra, Hypertrophy, Focal 3 [1.7] 2 [1.5] 1 [2.0] 1 [2.0]
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (50) (50) (49)
Compression, Focal 1 [3.0] 1 [3.0]
Artery, Meninges, Inflammation, Chronic 1 [2.0]
Spinal Cord (1) (2) (1) (1)
Demyelination, Focal 1 [3.0]
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (50) (50) (50)
Congestion 1 [3.0]
Foreign Body 1 [3.0] 1 [4.0]
Hemorrhage 1 [3.0] 1 [2.0]
Hyperplasia, Histiocytic 1 [1.0] 1 [3.0]
Hyperplasia, Lymphoid 1 [3.0]
Infiltration Cellular, Polymorphonuclear 1 [3.0]
Infiltration Cellular, Mixed Cell 1 [3.0]
Inflammation 1 [2.0] 1 [4.0]
Metaplasia, Focal, Osseous 1 [1.0]
Alveolar Epithelium, Hyperplasia, Focal 2 [1.5] 1 [1.0] 1 [2.0]
Mediastinum, Foreign Body 1 1
Mediastinum, Inflammation 1 [3.0] 1 [3.0]
Serosa, Fibrosis 1 [3.0]
Nose (50) (50) (50) (50)
Inflammation 3 [2.0] 7 [2.0] 11 [1.9]
Nasolacrimal Duct, Hyperplasia, Focal 1 [2.0]
Nasolacrimal Duct, Inflammation 1 [2.0]
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
a Number of animals examined microscopically at site and number of animals with lesion
b Average severity grade (1-minimal;2-mild;3-moderate;4-marked)
Page 6
NTP Experiment-Test: 91005-08 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 06/02/05
Route: GAVAGE METHYLENE BLUE TRIHYDRATE Time: 13:15:53
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 MG/KG 2.5 12.5 25
MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM - CONT
Eye (43) (48) (47) (47)
Atrophy 1 [4.0]
Cataract 1 [3.0]
Anterior Chamber, Inflammation 1 [3.0]
Artery, Retrobulbar, Inflammation, Chronic,
Focal 1 [2.0]
Cornea, Inflammation 1 [3.0] 1 [3.0] 1 [2.0] 1 [3.0]
Cornea, Necrosis, Focal 1 [3.0]
Harderian Gland (49) (50) (50) (50)
Epithelium, Hyperplasia 2 [1.5] 1 [1.0] 3 [2.3]
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (48) (50) (49) (50)
Hemorrhage 1 [3.0]
Hyperplasia, Lymphoid 1 [2.0]
Infarct 1 [3.0] 2 [2.5] 2 [2.0]
Metaplasia, Focal, Osseous 2 [2.0] 1 [1.0] 1 [2.0]
Nephropathy 6 [1.3] 5 [1.4] 9 [1.1] 5 [1.2]
Bilateral, Infarct 1 [4.0]
Capsule, Fibrosis, Focal 1 [2.0]
Renal Tubule, Accumulation, Hyaline Droplet 2 [3.0] 2 [2.5]
Renal Tubule, Cyst 1 3
Urinary Bladder (45) (47) (49) (48)
Hyperplasia, Lymphoid 1 [3.0]
Inflammation 1 [2.0]
Transitional Epithelium, Hyperplasia 1 [2.0] 1 [2.0]
a Number of animals examined microscopically at site and number of animals with lesion
b Average severity grade (1-minimal;2-mild;3-moderate;4-marked)
Page 7
NTP Experiment-Test: 91005-08 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 06/02/05
Route: GAVAGE METHYLENE BLUE TRIHYDRATE Time: 13:15:53
____________________________________________________________________________________________________________________________________
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
Esophagus (50) (50) (50) (50)
Foreign Body 1 [2.0] 1 [3.0]
Inflammation 1 [3.0] 1 [3.0] 1 [3.0]
Perforation 1 [3.0] 1 [3.0]
Intestine Large, Cecum (45) (46) (46) (47)
Edema 1 [3.0] 1 [3.0]
Inflammation, Chronic, Focal 1 [3.0]
Intestine Small, Duodenum (42) (46) (46) (46)
Epithelium, Cyst 1
Intestine Small, Jejunum (45) (45) (47) (47)
Inflammation 1 [2.0]
Lymphoid Tissue, Hyperplasia 1 [3.0]
Peyer's Patch, Hyperplasia, Lymphoid 1 [2.0]
Liver (50) (50) (50) (49)
Basophilic Focus 1
Clear Cell Focus 20 19 22 16
Congestion 1 [3.0]
Cyst 1 1
Eosinophilic Focus 2 2 2
Fibrosis, Focal 1 [3.0]
Hematopoietic Cell Proliferation 1 [1.0] 2 [2.5]
Hemorrhage 1 [3.0]
Hepatodiaphragmatic Nodule 1 1
Infarct 1 [4.0]
Infiltration Cellular, Mixed Cell 3 [1.7] 1 [1.0] 2 [1.0] 6 [1.3]
Mixed Cell Focus 3 1
Thrombosis 2 [3.0] 1 [3.0] 1 [3.0]
Bile Duct, Hyperplasia 1 [1.0]
a Number of animals examined microscopically at site and number of animals with lesion
b Average severity grade (1-minimal;2-mild;3-moderate;4-marked)
Page 8
NTP Experiment-Test: 91005-08 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 06/02/05
Route: GAVAGE METHYLENE BLUE TRIHYDRATE Time: 13:15:53
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 MG/KG 2.5 12.5 25
MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Hepatocyte, Necrosis, Focal 2 [2.5] 2 [3.0] 2 [3.0] 4 [2.0]
Hepatocyte, Syncytial Alteration, Focal 1 [1.0]
Hepatocyte, Vacuolization Cytoplasmic 29 [2.3] 19 [2.6] 32 [2.5] 23 [2.2]
Hepatocyte, Centrilobular, Necrosis 1 [3.0]
Mesentery (5) (11) (5) (4)
Inflammation 1 [3.0] 1 [2.0]
Fat, Necrosis, Focal 4 [3.0] 7 [2.3] 4 [2.5]
Pancreas (48) (50) (49) (48)
Acinus, Atrophy, Diffuse 1 [4.0]
Acinus, Atrophy, Focal 1 [2.0] 1 [1.0] 2 [2.0] 1 [1.0]
Acinus, Cytoplasmic Alteration 1 [1.0] 1 [2.0]
Acinus, Inflammation 1 [2.0]
Duct, Cyst 1
Stomach, Forestomach (50) (50) (50) (48)
Ulcer 3 [2.0] 1 [2.0]
Epithelium, Hyperplasia 3 [2.0] 2 [2.0] 3 [1.7] 2 [2.5]
Stomach, Glandular (47) (47) (47) (48)
Erosion 2 [2.0] 1 [2.0] 2 [2.0] 1 [2.0]
Ulcer 1 [3.0]
Tooth (43) (37) (33) (35)
Dysplasia 43 [2.7] 37 [2.5] 33 [2.4] 35 [2.6]
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (50) (50) (50) (50)
Infiltration Cellular, Mixed Cell 1 [2.0] 1 [2.0] 1 [2.0]
Mineralization, Focal 1 [3.0] 1 [1.0]
Artery, Inflammation, Chronic 1 [2.0]
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (48) (50) (50) (48)
Accessory Adrenal Cortical Nodule 1 [1.0] 1 [1.0]
Cytoplasmic Alteration, Focal 4 [1.5] 5 [1.6] 5 [1.8]
Degeneration, Cystic 1 [2.0] 1 [2.0]
Hyperplasia, Focal 1 [2.0]
Hypertrophy 1 [1.0]
Hypertrophy, Focal 1 [3.0]
Inflammation 1 [3.0]
Adrenal Medulla (48) (50) (50) (48)
Hyperplasia, Focal 2 [1.5] 1 [1.0] 1 [2.0] 1 [1.0]
a Number of animals examined microscopically at site and number of animals with lesion
b Average severity grade (1-minimal;2-mild;3-moderate;4-marked)
Page 9
NTP Experiment-Test: 91005-08 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 06/02/05
Route: GAVAGE METHYLENE BLUE TRIHYDRATE Time: 13:15:53
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 MG/KG 2.5 12.5 25
MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM - CONT
Islets, Pancreatic (50) (50) (49) (48)
Hyperplasia 17 [2.1] 17 [1.8] 7 [1.6] 13 [2.1]
Parathyroid Gland (46) (50) (48) (46)
Cyst 3 3 2
Pituitary Gland (50) (49) (49) (50)
Cyst 3 1 1 3
Pars Distalis, Hyperplasia, Focal 1 [2.0]
Thyroid Gland (50) (50) (49) (48)
Follicle, Degeneration, Cystic, Focal 6 [1.5] 12 [1.3] 11 [1.5] 7 [1.3]
Follicular Cell, Hyperplasia, Focal 14 [1.7] 5 [1.6] 11 [1.7] 11 [1.5]
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
Tissue NOS (1) (2) (1)
Foreign Body 1 [3.0]
Abdominal, Fibrosis 2 [3.0]
Abdominal, Inflammation 1 [3.0]
Pelvic, Inflammation 1 [3.0]
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Preputial Gland (50) (50) (50) (48)
Degeneration, Cystic 11 [3.0] 11 [2.9] 16 [2.9] 11 [3.0]
Inflammation, Chronic 2 [3.0] 1 [3.0] 2 [3.0] 3 [3.0]
Prostate (49) (50) (50) (50)
Inflammation 1 [2.0] 1 [3.0] 1 [2.0]
Epithelium, Hyperplasia 1 [3.0] 1 [3.0] 1 [2.0]
Seminal Vesicle (49) (50) (50) (49)
Dilatation 2 [3.0] 2 [3.0]
Epithelium, Hyperplasia 1 [1.0]
Testes (50) (50) (50) (50)
Angiectasis 1 [2.0]
Atrophy 1 [2.0] 1 [3.0]
Thrombosis 1 [2.0]
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (50) (50) (50) (50)
Hyperplasia 2 [3.0] 3 [3.0] 3 [3.0] 2 [3.0]
Lymph Node (5) (3) (3) (6)
a Number of animals examined microscopically at site and number of animals with lesion
b Average severity grade (1-minimal;2-mild;3-moderate;4-marked)
Page 10
NTP Experiment-Test: 91005-08 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 06/02/05
Route: GAVAGE METHYLENE BLUE TRIHYDRATE Time: 13:15:53
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 MG/KG 2.5 12.5 25
MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - CONT
Iliac, Hyperplasia, Lymphoid 1 [2.0]
Inguinal, Hyperplasia, Lymphoid 1 [3.0]
Mediastinal, Hemorrhage 1 [3.0]
Mediastinal, Hyperplasia, Lymphoid 1 [3.0]
Lymph Node, Mandibular (43) (46) (48) (47)
Hemorrhage 1 [3.0]
Hyperplasia, Lymphoid 2 [3.0] 1 [3.0] 2 [3.0]
Lymph Node, Mesenteric (47) (50) (48) (48)
Hematopoietic Cell Proliferation 1 [3.0]
Hemorrhage 3 [3.0]
Hyperplasia, Lymphoid 2 [3.5] 2 [3.0] 2 [3.0]
Spleen (49) (50) (49) (48)
Atrophy 1 [3.0]
Fibrosis, Focal 1 [2.0]
Hematopoietic Cell Proliferation 14 [2.6] 16 [2.7] 25 [2.8] 29 [2.5]
Hyperplasia, Lymphoid 7 [2.0] 6 [2.2] 2 [2.0] 3 [2.0]
Hyperplasia, Mast Cell 1 [2.0]
Lymphoid Follicle, Necrosis 1 [3.0] 1 [2.0]
Thymus (38) (47) (40) (44)
Angiectasis 1 [3.0]
Hyperplasia, Lymphoid 1 [3.0]
Epithelial Cell, Hyperplasia 1 [3.0]
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Skin (50) (50) (50) (50)
Cyst Epithelial Inclusion 1
Ulcer 2 [3.0]
Pinna, Inflammation, Focal 1 [2.0]
Subcutaneous Tissue, Edema 1 [2.0] 1 [3.0] 2 [3.0] 1 [3.0]
Subcutaneous Tissue, Inflammation, Focal,
Suppurative 1 [3.0]
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (50) (50) (50) (50)
Hyperostosis 2 [1.5]
Vertebra, Fracture 1 [3.0]
Skeletal Muscle (4) (1) (1)
Fibrosis, Focal 1 [1.0]
Inflammation 1 [2.0]
a Number of animals examined microscopically at site and number of animals with lesion
b Average severity grade (1-minimal;2-mild;3-moderate;4-marked)
Page 11
NTP Experiment-Test: 91005-08 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 06/02/05
Route: GAVAGE METHYLENE BLUE TRIHYDRATE Time: 13:15:53
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 MG/KG 2.5 12.5 25
MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (50) (50) (50)
Compression, Focal 1 [3.0]
Spinal Cord (4) (4) (1) (2)
Hemorrhage 2 [3.0]
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (50) (50) (50)
Congestion 1 [2.0] 1 [3.0] 1 [3.0]
Hemorrhage 1 [2.0] 1 [3.0]
Hyperplasia, Histiocytic 1 [2.0] 3 [3.0] 2 [1.5]
Inflammation 1 [2.0]
Thrombosis 1 [2.0]
Alveolar Epithelium, Hyperplasia, Focal 4 [1.5] 3 [1.7] 2 [1.0] 4 [1.3]
Mediastinum, Foreign Body 1
Mediastinum, Inflammation, Suppurative 1 [3.0]
Mediastinum, Thrombosis 1 [4.0]
Nose (50) (50) (50) (50)
Hyperplasia 1 [3.0]
Inflammation 1 [2.0] 3 [1.3] 3 [2.3] 6 [1.8]
Nasolacrimal Duct, Hyperplasia, Focal 1 [3.0] 1 [2.0]
Nasolacrimal Duct, Inflammation 3 [2.0] 1 [2.0] 1 [1.0]
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (45) (49) (49) (47)
Atrophy 1 [4.0]
Cataract 1 [2.0]
Cornea, Inflammation 2 [2.0] 1 [2.0]
Cornea, Necrosis, Focal 1 [2.0]
Retrobulbar, Inflammation, Chronic, Focal 1 [3.0]
Harderian Gland (50) (50) (50) (50)
Cyst 1
Inflammation 1 [3.0] 1 [1.0]
Epithelium, Hyperplasia 2 [2.0] 2 [2.0]
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
a Number of animals examined microscopically at site and number of animals with lesion
b Average severity grade (1-minimal;2-mild;3-moderate;4-marked)
Page 12
NTP Experiment-Test: 91005-08 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 06/02/05
Route: GAVAGE METHYLENE BLUE TRIHYDRATE Time: 13:15:53
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 MG/KG 2.5 12.5 25
MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
URINARY SYSTEM - CONT
Kidney (49) (49) (50) (48)
Hydronephrosis 2 [3.0]
Hyperplasia, Lymphoid 1 [3.0]
Infarct 1 [2.0] 1 [2.0]
Metaplasia, Focal, Osseous 3 [1.3] 3 [1.0] 4 [1.3]
Mineralization, Focal 1 [2.0]
Nephropathy 40 [1.5] 44 [1.7] 44 [1.7] 43 [1.5]
Artery, Inflammation, Chronic 1 [2.0]
Renal Tubule, Accumulation, Hyaline Droplet 1 [2.0]
Renal Tubule, Cyst 4 2 3 2
Renal Tubule, Hyperplasia, Atypical 1 [2.0]
Renal Tubule, Hyperplasia, Focal 3 [1.3] 2 [2.5] 1 [1.0] 2 [1.5]
Renal Tubule, Pigmentation 1 [2.0]
Urethra (1)
Inflammation, Chronic 1 [3.0]
Urinary Bladder (48) (50) (50) (48)
Transitional Epithelium, Hyperplasia 1 [3.0]
a Number of animals examined microscopically at site and number of animals with lesion
b Average severity grade (1-minimal;2-mild;3-moderate;4-marked)
Page 13
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