TDMS Study 91005-08 Pathology Tables
NTP Experiment-Test: 91005-08 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC METHYLENE BLUE TRIHYDRATE Date: 06/02/05
Route: GAVAGE Time: 13:15:21
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
Page 1
NTP Experiment-Test: 91005-08 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC METHYLENE BLUE TRIHYDRATE Date: 06/02/05
Route: GAVAGE Time: 13:15:21
____________________________________________________________________________________________________________________________________
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 (2%)
Inflammation 1 (2%)
Perforation 1 (2%)
Gallbladder (42) (45) (47) (44)
Cyst 2 (5%) 1 (2%) 2 (5%)
Intestine Large, Rectum (48) (48) (50) (46)
Artery, Inflammation, Chronic, Focal 1 (2%)
Intestine Large, Cecum (43) (46) (47) (44)
Edema 1 (2%)
Lymphoid Tissue, Hyperplasia, Lymphoid 1 (2%)
Intestine Small, Duodenum (43) (45) (47) (42)
Epithelium, Hyperplasia, Focal 1 (2%)
Intestine Small, Jejunum (43) (45) (47) (43)
Epithelium, Hyperplasia, Focal 1 (2%)
Lymphoid Tissue, Hyperplasia 1 (2%)
Liver (50) (50) (50) (50)
Angiectasis, Focal 2 (4%)
Basophilic Focus 1 (2%) 3 (6%)
Clear Cell Focus 3 (6%) 3 (6%) 4 (8%) 2 (4%)
Congestion 1 (2%) 2 (4%) 1 (2%) 1 (2%)
Eosinophilic Focus 1 (2%) 1 (2%) 3 (6%) 1 (2%)
Fibrosis, Focal 1 (2%)
Hematopoietic Cell Proliferation 4 (8%) 1 (2%) 6 (12%) 2 (4%)
Hemorrhage 1 (2%) 1 (2%)
Hepatodiaphragmatic Nodule 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 2
NTP Experiment-Test: 91005-08 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC METHYLENE BLUE TRIHYDRATE Date: 06/02/05
Route: GAVAGE Time: 13:15:21
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 MG/KG 2.5 12.5 25
MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Infarct 1 (2%)
Infiltration Cellular, Mixed Cell 11 (22%) 12 (24%) 12 (24%) 15 (30%)
Mixed Cell Focus 2 (4%) 1 (2%) 1 (2%)
Bile Duct, Cyst 1 (2%)
Hepatocyte, Necrosis, Focal 3 (6%) 3 (6%) 1 (2%)
Hepatocyte, Vacuolization Cytoplasmic 12 (24%) 11 (22%) 8 (16%) 15 (30%)
Kupffer Cell, Pigmentation 1 (2%) 1 (2%)
Mesentery (18) (14) (15) (13)
Hemorrhage 1 (7%) 1 (8%)
Infiltration Cellular, Lymphoid 1 (7%)
Artery, Inflammation, Chronic, Focal 1 (6%) 1 (7%) 1 (7%)
Fat, Necrosis, Focal 16 (89%) 12 (86%) 13 (87%) 4 (31%)
Pancreas (46) (46) (49) (49)
Acinus, Atrophy, Diffuse 1 (2%)
Acinus, Atrophy, Focal 1 (2%) 1 (2%) 1 (2%)
Acinus, Cytoplasmic Alteration 1 (2%)
Duct, Cyst 2 (4%) 2 (4%) 2 (4%)
Salivary Glands (50) (50) (50) (49)
Hyperplasia, Lymphoid 1 (2%)
Stomach, Forestomach (50) (50) (50) (49)
Diverticulum 1 (2%) 1 (2%) 3 (6%)
Inflammation, Focal 1 (2%) 1 (2%)
Ulcer 2 (4%) 3 (6%) 1 (2%)
Epithelium, Hyperplasia 2 (4%) 2 (4%) 2 (4%) 1 (2%)
Stomach, Glandular (45) (47) (50) (46)
Cyst 1 (2%) 1 (2%)
Epithelium, Cytoplasmic Alteration, Focal 1 (2%)
Epithelium, Hyperplasia 1 (2%)
Tooth (2) (10) (3) (3)
Dysplasia 2 (100%) 10 (100%) 3 (100%) 3 (100%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Blood Vessel (1)
Aneurysm 1 (100%)
Heart (50) (50) (50) (50)
Cardiomyopathy 1 (2%) 1 (2%)
Infiltration Cellular, Mixed Cell 1 (2%)
Mineralization, Focal 1 (2%)
Thrombosis 1 (2%)
Artery, Inflammation, Chronic 1 (2%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 3
NTP Experiment-Test: 91005-08 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC METHYLENE BLUE TRIHYDRATE Date: 06/02/05
Route: GAVAGE Time: 13:15:21
____________________________________________________________________________________________________________________________________
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 (4%) 2 (4%)
Angiectasis 1 (2%)
Cytoplasmic Alteration, Focal 1 (2%)
Degeneration, Cystic 1 (2%)
Hyperplasia, Focal 1 (2%)
Infiltration Cellular, Mixed Cell 1 (2%)
Adrenal Medulla (50) (50) (49) (50)
Hyperplasia, Focal 1 (2%)
Parathyroid Gland (48) (48) (46) (49)
Cyst 1 (2%) 1 (2%) 1 (2%) 1 (2%)
Pituitary Gland (46) (49) (48) (47)
Angiectasis 2 (4%) 1 (2%)
Cyst 1 (2%) 1 (2%)
Pars Distalis, Cytoplasmic Alteration, Focal 1 (2%) 4 (8%) 1 (2%) 2 (4%)
Pars Distalis, Hyperplasia, Focal 1 (2%) 1 (2%) 1 (2%) 1 (2%)
Thyroid Gland (46) (50) (49) (47)
Cyst 1 (2%) 1 (2%)
Inflammation, Chronic, Focal 1 (2%) 1 (2%) 1 (2%)
C-Cell, Hyperplasia 1 (2%) 1 (2%)
Follicle, Degeneration, Cystic, Focal 17 (37%) 15 (30%) 28 (57%) 23 (49%)
Follicular Cell, Hyperplasia, Focal 5 (11%) 2 (4%) 4 (8%) 5 (11%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
Tissue NOS (3) (3)
Pelvic, Fibrosis 1 (33%)
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Clitoral Gland (48) (50) (46) (48)
Degeneration, Cystic 1 (2%) 1 (2%)
Ovary (47) (48) (49) (48)
Angiectasis 3 (6%) 2 (4%) 2 (4%)
Cyst 11 (23%) 12 (25%) 16 (33%) 13 (27%)
Hemorrhage 1 (2%) 1 (2%)
Pigmentation, Focal 1 (2%)
Thrombosis 3 (6%) 3 (6%)
Bilateral, Cyst 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 4
NTP Experiment-Test: 91005-08 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC METHYLENE BLUE TRIHYDRATE Date: 06/02/05
Route: GAVAGE Time: 13:15:21
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 MG/KG 2.5 12.5 25
MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM - CONT
Interstitial Cell, Hyperplasia 1 (2%)
Uterus (50) (50) (50) (50)
Angiectasis 1 (2%) 1 (2%) 1 (2%)
Hemorrhage 1 (2%)
Inflammation, Chronic 1 (2%)
Inflammation, Suppurative 1 (2%)
Endometrium, Hyperplasia, Cystic 48 (96%) 45 (90%) 49 (98%) 48 (96%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (50) (50) (49) (50)
Hyperplasia 10 (20%) 4 (8%) 9 (18%) 4 (8%)
Lymph Node (7) (5) (10) (10)
Iliac, Angiectasis 1 (14%)
Iliac, Hyperplasia, Lymphoid 1 (14%) 2 (20%) 2 (20%)
Mediastinal, Hyperplasia, Lymphoid 2 (29%) 1 (10%)
Mediastinal, Inflammation 1 (10%)
Pancreatic, Hyperplasia, Lymphoid 1 (20%) 1 (10%) 1 (10%)
Renal, Hyperplasia, Lymphoid 1 (14%) 1 (10%) 1 (10%)
Lymph Node, Mandibular (48) (49) (48) (46)
Hemorrhage 1 (2%)
Hyperplasia, Lymphoid 9 (19%) 11 (22%) 12 (25%) 16 (35%)
Hyperplasia, Mast Cell 1 (2%)
Lymph Node, Mesenteric (46) (49) (49) (48)
Ectasia 1 (2%) 2 (4%)
Hemorrhage 1 (2%) 2 (4%) 2 (4%) 1 (2%)
Hyperplasia, Histiocytic 1 (2%)
Hyperplasia, Lymphoid 6 (13%) 7 (14%) 10 (20%) 8 (17%)
Spleen (47) (47) (49) (50)
Angiectasis, Focal 1 (2%)
Congestion 2 (4%)
Fibrosis, Focal 1 (2%) 1 (2%)
Hematopoietic Cell Proliferation 23 (49%) 21 (45%) 31 (63%) 40 (80%)
Hyperplasia, Lymphoid 17 (36%) 15 (32%) 17 (35%) 11 (22%)
Thymus (43) (47) (44) (49)
Hyperplasia, Lymphoid 8 (19%) 13 (28%) 11 (25%) 14 (29%)
Inflammation 1 (2%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Skin (50) (50) (50) (50)
a Number of animals examined microscopically at site and number of animals with lesion
Page 5
NTP Experiment-Test: 91005-08 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC METHYLENE BLUE TRIHYDRATE Date: 06/02/05
Route: GAVAGE Time: 13:15:21
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 MG/KG 2.5 12.5 25
MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM - CONT
Subcutaneous Tissue, Edema 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (50) (50) (50) (50)
Hyperostosis 5 (10%) 5 (10%) 4 (8%) 5 (10%)
Vertebra, Hypertrophy, Focal 3 (6%) 2 (4%) 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (50) (50) (49)
Compression, Focal 1 (2%) 1 (2%)
Artery, Meninges, Inflammation, Chronic 1 (2%)
Spinal Cord (1) (2) (1) (1)
Demyelination, Focal 1 (50%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (50) (50) (50)
Congestion 1 (2%)
Foreign Body 1 (2%) 1 (2%)
Hemorrhage 1 (2%) 1 (2%)
Hyperplasia, Histiocytic 1 (2%) 1 (2%)
Hyperplasia, Lymphoid 1 (2%)
Infiltration Cellular, Polymorphonuclear 1 (2%)
Infiltration Cellular, Mixed Cell 1 (2%)
Inflammation 1 (2%) 1 (2%)
Metaplasia, Focal, Osseous 1 (2%)
Alveolar Epithelium, Hyperplasia, Focal 2 (4%) 1 (2%) 1 (2%)
Mediastinum, Foreign Body 1 (2%) 1 (2%)
Mediastinum, Inflammation 1 (2%) 1 (2%)
Serosa, Fibrosis 1 (2%)
Nose (50) (50) (50) (50)
Inflammation 3 (6%) 7 (14%) 11 (22%)
Nasolacrimal Duct, Hyperplasia, Focal 1 (2%)
Nasolacrimal Duct, Inflammation 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
a Number of animals examined microscopically at site and number of animals with lesion
Page 6
NTP Experiment-Test: 91005-08 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC METHYLENE BLUE TRIHYDRATE Date: 06/02/05
Route: GAVAGE Time: 13:15:21
____________________________________________________________________________________________________________________________________
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 (2%)
Cataract 1 (2%)
Anterior Chamber, Inflammation 1 (2%)
Artery, Retrobulbar, Inflammation, Chronic,
Focal 1 (2%)
Cornea, Inflammation 1 (2%) 1 (2%) 1 (2%) 1 (2%)
Cornea, Necrosis, Focal 1 (2%)
Harderian Gland (49) (50) (50) (50)
Epithelium, Hyperplasia 2 (4%) 1 (2%) 3 (6%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (48) (50) (49) (50)
Hemorrhage 1 (2%)
Hyperplasia, Lymphoid 1 (2%)
Infarct 1 (2%) 2 (4%) 2 (4%)
Metaplasia, Focal, Osseous 2 (4%) 1 (2%) 1 (2%)
Nephropathy 6 (13%) 5 (10%) 9 (18%) 5 (10%)
Bilateral, Infarct 1 (2%)
Capsule, Fibrosis, Focal 1 (2%)
Renal Tubule, Accumulation, Hyaline Droplet 2 (4%) 2 (4%)
Renal Tubule, Cyst 1 (2%) 3 (6%)
Urinary Bladder (45) (47) (49) (48)
Hyperplasia, Lymphoid 1 (2%)
Inflammation 1 (2%)
Transitional Epithelium, Hyperplasia 1 (2%) 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 7
NTP Experiment-Test: 91005-08 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC METHYLENE BLUE TRIHYDRATE Date: 06/02/05
Route: GAVAGE Time: 13:15:21
____________________________________________________________________________________________________________________________________
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%) 1 (2%)
Inflammation 1 (2%) 1 (2%) 1 (2%)
Perforation 1 (2%) 1 (2%)
Intestine Large, Cecum (45) (46) (46) (47)
Edema 1 (2%) 1 (2%)
Inflammation, Chronic, Focal 1 (2%)
Intestine Small, Duodenum (42) (46) (46) (46)
Epithelium, Cyst 1 (2%)
Intestine Small, Jejunum (45) (45) (47) (47)
Inflammation 1 (2%)
Lymphoid Tissue, Hyperplasia 1 (2%)
Peyer's Patch, Hyperplasia, Lymphoid 1 (2%)
Liver (50) (50) (50) (49)
Basophilic Focus 1 (2%)
Clear Cell Focus 20 (40%) 19 (38%) 22 (44%) 16 (33%)
Congestion 1 (2%)
Cyst 1 (2%) 1 (2%)
Eosinophilic Focus 2 (4%) 2 (4%) 2 (4%)
Fibrosis, Focal 1 (2%)
Hematopoietic Cell Proliferation 1 (2%) 2 (4%)
Hemorrhage 1 (2%)
Hepatodiaphragmatic Nodule 1 (2%) 1 (2%)
Infarct 1 (2%)
Infiltration Cellular, Mixed Cell 3 (6%) 1 (2%) 2 (4%) 6 (12%)
Mixed Cell Focus 3 (6%) 1 (2%)
Thrombosis 2 (4%) 1 (2%) 1 (2%)
Bile Duct, Hyperplasia 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 8
NTP Experiment-Test: 91005-08 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC METHYLENE BLUE TRIHYDRATE Date: 06/02/05
Route: GAVAGE Time: 13:15:21
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 MG/KG 2.5 12.5 25
MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Hepatocyte, Necrosis, Focal 2 (4%) 2 (4%) 2 (4%) 4 (8%)
Hepatocyte, Syncytial Alteration, Focal 1 (2%)
Hepatocyte, Vacuolization Cytoplasmic 29 (58%) 19 (38%) 32 (64%) 23 (47%)
Hepatocyte, Centrilobular, Necrosis 1 (2%)
Mesentery (5) (11) (5) (4)
Inflammation 1 (9%) 1 (25%)
Fat, Necrosis, Focal 4 (80%) 7 (64%) 4 (80%)
Pancreas (48) (50) (49) (48)
Acinus, Atrophy, Diffuse 1 (2%)
Acinus, Atrophy, Focal 1 (2%) 1 (2%) 2 (4%) 1 (2%)
Acinus, Cytoplasmic Alteration 1 (2%) 1 (2%)
Acinus, Inflammation 1 (2%)
Duct, Cyst 1 (2%)
Stomach, Forestomach (50) (50) (50) (48)
Ulcer 3 (6%) 1 (2%)
Epithelium, Hyperplasia 3 (6%) 2 (4%) 3 (6%) 2 (4%)
Stomach, Glandular (47) (47) (47) (48)
Erosion 2 (4%) 1 (2%) 2 (4%) 1 (2%)
Ulcer 1 (2%)
Tooth (43) (37) (33) (35)
Dysplasia 43 (100%) 37 (100%) 33 (100%) 35 (100%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (50) (50) (50) (50)
Infiltration Cellular, Mixed Cell 1 (2%) 1 (2%) 1 (2%)
Mineralization, Focal 1 (2%) 1 (2%)
Artery, Inflammation, Chronic 1 (2%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (48) (50) (50) (48)
Accessory Adrenal Cortical Nodule 1 (2%) 1 (2%)
Cytoplasmic Alteration, Focal 4 (8%) 5 (10%) 5 (10%)
Degeneration, Cystic 1 (2%) 1 (2%)
Hyperplasia, Focal 1 (2%)
Hypertrophy 1 (2%)
Hypertrophy, Focal 1 (2%)
Inflammation 1 (2%)
Adrenal Medulla (48) (50) (50) (48)
Hyperplasia, Focal 2 (4%) 1 (2%) 1 (2%) 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 9
NTP Experiment-Test: 91005-08 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC METHYLENE BLUE TRIHYDRATE Date: 06/02/05
Route: GAVAGE Time: 13:15:21
____________________________________________________________________________________________________________________________________
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 (34%) 17 (34%) 7 (14%) 13 (27%)
Parathyroid Gland (46) (50) (48) (46)
Cyst 3 (6%) 3 (6%) 2 (4%)
Pituitary Gland (50) (49) (49) (50)
Cyst 3 (6%) 1 (2%) 1 (2%) 3 (6%)
Pars Distalis, Hyperplasia, Focal 1 (2%)
Thyroid Gland (50) (50) (49) (48)
Follicle, Degeneration, Cystic, Focal 6 (12%) 12 (24%) 11 (22%) 7 (15%)
Follicular Cell, Hyperplasia, Focal 14 (28%) 5 (10%) 11 (22%) 11 (23%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
Tissue NOS (1) (2) (1)
Foreign Body 1 (100%)
Abdominal, Fibrosis 2 (100%)
Abdominal, Inflammation 1 (50%)
Pelvic, Inflammation 1 (100%)
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Preputial Gland (50) (50) (50) (48)
Degeneration, Cystic 11 (22%) 11 (22%) 16 (32%) 11 (23%)
Inflammation, Chronic 2 (4%) 1 (2%) 2 (4%) 3 (6%)
Prostate (49) (50) (50) (50)
Inflammation 1 (2%) 1 (2%) 1 (2%)
Epithelium, Hyperplasia 1 (2%) 1 (2%) 1 (2%)
Seminal Vesicle (49) (50) (50) (49)
Dilatation 2 (4%) 2 (4%)
Epithelium, Hyperplasia 1 (2%)
Testes (50) (50) (50) (50)
Angiectasis 1 (2%)
Atrophy 1 (2%) 1 (2%)
Thrombosis 1 (2%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (50) (50) (50) (50)
Hyperplasia 2 (4%) 3 (6%) 3 (6%) 2 (4%)
Lymph Node (5) (3) (3) (6)
a Number of animals examined microscopically at site and number of animals with lesion
Page 10
NTP Experiment-Test: 91005-08 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC METHYLENE BLUE TRIHYDRATE Date: 06/02/05
Route: GAVAGE Time: 13:15:21
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 MG/KG 2.5 12.5 25
MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - CONT
Iliac, Hyperplasia, Lymphoid 1 (33%)
Inguinal, Hyperplasia, Lymphoid 1 (20%)
Mediastinal, Hemorrhage 1 (33%)
Mediastinal, Hyperplasia, Lymphoid 1 (17%)
Lymph Node, Mandibular (43) (46) (48) (47)
Hemorrhage 1 (2%)
Hyperplasia, Lymphoid 2 (5%) 1 (2%) 2 (4%)
Lymph Node, Mesenteric (47) (50) (48) (48)
Hematopoietic Cell Proliferation 1 (2%)
Hemorrhage 3 (6%)
Hyperplasia, Lymphoid 2 (4%) 2 (4%) 2 (4%)
Spleen (49) (50) (49) (48)
Atrophy 1 (2%)
Fibrosis, Focal 1 (2%)
Hematopoietic Cell Proliferation 14 (29%) 16 (32%) 25 (51%) 29 (60%)
Hyperplasia, Lymphoid 7 (14%) 6 (12%) 2 (4%) 3 (6%)
Hyperplasia, Mast Cell 1 (2%)
Lymphoid Follicle, Necrosis 1 (2%) 1 (2%)
Thymus (38) (47) (40) (44)
Angiectasis 1 (2%)
Hyperplasia, Lymphoid 1 (2%)
Epithelial Cell, Hyperplasia 1 (2%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Skin (50) (50) (50) (50)
Cyst Epithelial Inclusion 1 (2%)
Ulcer 2 (4%)
Pinna, Inflammation, Focal 1 (2%)
Subcutaneous Tissue, Edema 1 (2%) 1 (2%) 2 (4%) 1 (2%)
Subcutaneous Tissue, Inflammation, Focal,
Suppurative 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (50) (50) (50) (50)
Hyperostosis 2 (4%)
Vertebra, Fracture 1 (2%)
Skeletal Muscle (4) (1) (1)
Fibrosis, Focal 1 (25%)
Inflammation 1 (25%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 11
NTP Experiment-Test: 91005-08 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC METHYLENE BLUE TRIHYDRATE Date: 06/02/05
Route: GAVAGE Time: 13:15:21
____________________________________________________________________________________________________________________________________
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 (2%)
Spinal Cord (4) (4) (1) (2)
Hemorrhage 2 (50%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (50) (50) (50)
Congestion 1 (2%) 1 (2%) 1 (2%)
Hemorrhage 1 (2%) 1 (2%)
Hyperplasia, Histiocytic 1 (2%) 3 (6%) 2 (4%)
Inflammation 1 (2%)
Thrombosis 1 (2%)
Alveolar Epithelium, Hyperplasia, Focal 4 (8%) 3 (6%) 2 (4%) 4 (8%)
Mediastinum, Foreign Body 1 (2%)
Mediastinum, Inflammation, Suppurative 1 (2%)
Mediastinum, Thrombosis 1 (2%)
Nose (50) (50) (50) (50)
Hyperplasia 1 (2%)
Inflammation 1 (2%) 3 (6%) 3 (6%) 6 (12%)
Nasolacrimal Duct, Hyperplasia, Focal 1 (2%) 1 (2%)
Nasolacrimal Duct, Inflammation 3 (6%) 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (45) (49) (49) (47)
Atrophy 1 (2%)
Cataract 1 (2%)
Cornea, Inflammation 2 (4%) 1 (2%)
Cornea, Necrosis, Focal 1 (2%)
Retrobulbar, Inflammation, Chronic, Focal 1 (2%)
Harderian Gland (50) (50) (50) (50)
Cyst 1 (2%)
Inflammation 1 (2%) 1 (2%)
Epithelium, Hyperplasia 2 (4%) 2 (4%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
a Number of animals examined microscopically at site and number of animals with lesion
Page 12
NTP Experiment-Test: 91005-08 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC METHYLENE BLUE TRIHYDRATE Date: 06/02/05
Route: GAVAGE Time: 13:15:21
____________________________________________________________________________________________________________________________________
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 (4%)
Hyperplasia, Lymphoid 1 (2%)
Infarct 1 (2%) 1 (2%)
Metaplasia, Focal, Osseous 3 (6%) 3 (6%) 4 (8%)
Mineralization, Focal 1 (2%)
Nephropathy 40 (82%) 44 (90%) 44 (88%) 43 (90%)
Artery, Inflammation, Chronic 1 (2%)
Renal Tubule, Accumulation, Hyaline Droplet 1 (2%)
Renal Tubule, Cyst 4 (8%) 2 (4%) 3 (6%) 2 (4%)
Renal Tubule, Hyperplasia, Atypical 1 (2%)
Renal Tubule, Hyperplasia, Focal 3 (6%) 2 (4%) 1 (2%) 2 (4%)
Renal Tubule, Pigmentation 1 (2%)
Urethra (1)
Inflammation, Chronic 1 (100%)
Urinary Bladder (48) (50) (50) (48)
Transitional Epithelium, Hyperplasia 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
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