TDMS Study 91005-07 Pathology Tables
NTP Experiment-Test: 91005-07 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC METHYLENE BLUE TRIHYDRATE Date: 03/25/05
Route: GAVAGE Time: 10:00:58
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 NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC METHYLENE BLUE TRIHYDRATE Date: 03/25/05
Route: GAVAGE Time: 10:00:58
____________________________________________________________________________________________________________________________________
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
Esophagus (50) (49) (50) (50)
Perforation 1 (2%)
Intestine Large, Colon (50) (48) (49) (48)
Cyst 1 (2%)
Intestine Small, Duodenum (49) (48) (49) (48)
Ectopic Tissue 1 (2%)
Liver (50) (49) (50) (50)
Basophilic Focus 37 (74%) 34 (69%) 38 (76%) 40 (80%)
Clear Cell Focus 8 (16%) 5 (10%) 9 (18%) 8 (16%)
Degeneration, Cystic 1 (2%) 1 (2%) 1 (2%)
Eosinophilic Focus 3 (6%) 2 (4%)
Hepatodiaphragmatic Nodule 7 (14%) 4 (8%) 7 (14%) 4 (8%)
Inflammation, Chronic 6 (12%) 4 (8%) 4 (8%) 5 (10%)
Necrosis, Focal 1 (2%) 1 (2%)
Bile Duct, Hyperplasia 7 (14%) 5 (10%) 6 (12%) 2 (4%)
Centrilobular, Necrosis 2 (4%) 1 (2%)
Hepatocyte, Vacuolization Cytoplasmic 4 (8%) 4 (8%)
Mesentery (17) (14) (12) (8)
Accessory Spleen 1 (7%)
Fat, Necrosis 17 (100%) 14 (100%) 11 (92%) 8 (100%)
Oral Mucosa (2) (1)
Pharyngeal, Cyst 1 (50%) 1 (100%)
Pancreas (49) (48) (48) (49)
Atrophy 26 (53%) 20 (42%) 23 (48%) 23 (47%)
Inflammation 1 (2%)
Acinus, Hyperplasia, Focal 3 (6%) 1 (2%) 2 (4%) 1 (2%)
Salivary Glands (50) (49) (50) (50)
a Number of animals examined microscopically at site and number of animals with lesion
Page 2
NTP Experiment-Test: 91005-07 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC METHYLENE BLUE TRIHYDRATE Date: 03/25/05
Route: GAVAGE Time: 10:00:58
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 MG/KG 5 MG/KG 25 MG/KG 50 MG/KG
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Inflammation 1 (2%)
Stomach, Forestomach (50) (49) (49) (49)
Edema 2 (4%) 3 (6%) 1 (2%)
Erosion 1 (2%)
Inflammation, Chronic Active 1 (2%) 2 (4%)
Ulcer 4 (8%) 3 (6%) 1 (2%) 1 (2%)
Epithelium, Hyperplasia 2 (4%) 2 (4%) 2 (4%) 3 (6%)
Stomach, Glandular (50) (49) (48) (49)
Edema 2 (4%) 1 (2%) 1 (2%)
Erosion 2 (4%) 2 (4%)
Ulcer 2 (4%) 1 (2%) 1 (2%)
Tongue (1) (1) (1) (1)
Cyst 1 (100%)
Hyperplasia 1 (100%) 1 (100%)
Inflammation 1 (100%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (50) (49) (50) (50)
Cardiomyopathy 36 (72%) 41 (84%) 36 (72%) 32 (64%)
Thrombosis 1 (2%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (50) (49) (50) (50)
Accessory Adrenal Cortical Nodule 9 (18%) 7 (14%) 8 (16%) 12 (24%)
Degeneration, Fatty 11 (22%) 13 (27%) 13 (26%) 8 (16%)
Hyperplasia, Focal 5 (10%) 8 (16%) 8 (16%) 6 (12%)
Hypertrophy, Focal 12 (24%) 11 (22%) 13 (26%) 7 (14%)
Necrosis 2 (4%) 1 (2%)
Adrenal Medulla (50) (49) (50) (50)
Hyperplasia 1 (2%) 2 (4%) 1 (2%)
Islets, Pancreatic (49) (48) (48) (49)
Hyperplasia 13 (27%) 15 (31%) 15 (31%) 15 (31%)
Metaplasia, Hepatocyte 2 (4%)
Pituitary Gland (50) (49) (50) (50)
Pars Distalis, Angiectasis 28 (56%) 27 (55%) 29 (58%) 21 (42%)
Pars Distalis, Cyst 21 (42%) 19 (39%) 16 (32%) 23 (46%)
Pars Distalis, Hyperplasia, Focal 5 (10%) 8 (16%) 6 (12%) 6 (12%)
Pars Intermedia, Cyst 1 (2%)
Thyroid Gland (50) (49) (50) (50)
a Number of animals examined microscopically at site and number of animals with lesion
Page 3
NTP Experiment-Test: 91005-07 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC METHYLENE BLUE TRIHYDRATE Date: 03/25/05
Route: GAVAGE Time: 10:00:58
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 MG/KG 5 MG/KG 25 MG/KG 50 MG/KG
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM - CONT
Ultimobranchial Cyst 2 (4%) 1 (2%)
C-Cell, Hyperplasia 10 (20%) 11 (22%) 7 (14%) 5 (10%)
Follicle, Cyst 2 (4%) 1 (2%) 2 (4%) 4 (8%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Clitoral Gland (50) (48) (50) (50)
Cyst 4 (8%) 7 (15%) 4 (8%) 6 (12%)
Inflammation, Chronic 1 (2%) 5 (10%) 2 (4%) 4 (8%)
Ovary (50) (49) (50) (50)
Cyst 11 (22%) 4 (8%) 9 (18%) 10 (20%)
Uterus (50) (49) (50) (50)
Cyst 1 (2%) 3 (6%) 2 (4%) 3 (6%)
Hemorrhage 1 (2%) 1 (2%)
Hydrometra 1 (2%) 4 (8%) 2 (4%) 1 (2%)
Cervix, Cyst 1 (2%)
Endometrium, Hyperplasia, Cystic 4 (8%) 1 (2%) 2 (4%)
Vagina (1)
Cyst 1 (100%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (50) (49) (50) (50)
Hyperplasia 8 (16%) 8 (16%) 9 (18%) 6 (12%)
Lymph Node (15) (8) (11) (3)
Mediastinal, Congestion 1 (7%)
Mediastinal, Hyperplasia, Lymphoid 5 (33%) 7 (88%) 8 (73%) 2 (67%)
Pancreatic, Hyperplasia, Lymphoid 1 (7%) 1 (9%) 1 (33%)
Lymph Node, Mesenteric (49) (49) (50) (50)
Hyperplasia, Lymphoid 1 (2%) 1 (2%)
Spleen (49) (48) (49) (49)
Fibrosis 2 (4%)
Hematopoietic Cell Proliferation 3 (6%) 5 (10%) 7 (14%) 8 (16%)
Necrosis 1 (2%)
Capsule, Fibrosis 8 (16%) 17 (35%) 12 (24%) 20 (41%)
Lymphoid Follicle, Atrophy 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 4
NTP Experiment-Test: 91005-07 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC METHYLENE BLUE TRIHYDRATE Date: 03/25/05
Route: GAVAGE Time: 10:00:58
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 MG/KG 5 MG/KG 25 MG/KG 50 MG/KG
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - CONT
Lymphoid Follicle, Hyperplasia 1 (2%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (50) (49) (50) (50)
Cyst 2 (4%) 1 (2%)
Galactocele 1 (2%) 1 (2%) 1 (2%)
Hyperplasia 18 (36%) 19 (39%) 9 (18%) 7 (14%)
Hyperplasia, Atypical 3 (6%) 3 (6%) 1 (2%)
Duct, Dilatation 31 (62%) 28 (57%) 29 (58%) 24 (48%)
Duct, Hyperplasia 2 (4%) 1 (2%)
Skin (50) (49) (50) (50)
Inflammation, Chronic 2 (4%)
Inflammation, Chronic Active 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (50) (49) (50) (50)
Inflammation 1 (2%)
Cranium, Osteopetrosis 1 (2%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (49) (50) (50)
Compression 3 (6%) 8 (16%) 6 (12%) 5 (10%)
Hemorrhage 1 (2%) 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (49) (50) (50)
Congestion 5 (10%) 2 (4%) 5 (10%) 8 (16%)
Foreign Body 1 (2%)
Infiltration Cellular, Histiocyte 41 (82%) 37 (76%) 39 (78%) 38 (76%)
Inflammation, Chronic 29 (58%) 33 (67%) 29 (58%) 33 (66%)
Inflammation, Suppurative 1 (2%)
Necrosis 1 (2%)
Alveolar Epithelium, Hyperplasia 1 (2%) 4 (8%) 3 (6%) 2 (4%)
Nose (50) (49) (50) (50)
Foreign Body 4 (8%) 3 (6%) 1 (2%) 3 (6%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 5
NTP Experiment-Test: 91005-07 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC METHYLENE BLUE TRIHYDRATE Date: 03/25/05
Route: GAVAGE Time: 10:00:58
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 MG/KG 5 MG/KG 25 MG/KG 50 MG/KG
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM - CONT
Inflammation, Chronic 8 (16%) 7 (14%) 9 (18%) 6 (12%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (50) (49) (50) (50)
Cataract 1 (2%) 2 (4%) 5 (10%) 3 (6%)
Inflammation, Chronic 2 (4%)
Anterior Chamber, Inflammation 1 (2%)
Cornea, Inflammation, Chronic 1 (2%) 1 (2%) 2 (4%)
Retina, Degeneration 2 (4%) 2 (4%) 4 (8%) 2 (4%)
Harderian Gland (50) (49) (50) (50)
Inflammation, Chronic 3 (6%) 3 (6%) 3 (6%) 4 (8%)
Pigmentation 2 (4%) 2 (4%) 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (49) (50) (50)
Cyst 1 (2%) 1 (2%)
Infarct 1 (2%) 2 (4%) 2 (4%)
Nephropathy 14 (28%) 15 (31%) 21 (42%) 16 (32%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 6
NTP Experiment-Test: 91005-07 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC METHYLENE BLUE TRIHYDRATE Date: 03/25/05
Route: GAVAGE Time: 10:00:58
____________________________________________________________________________________________________________________________________
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
Esophagus (50) (50) (50) (50)
Perforation 2 (4%)
Intestine Large, Colon (50) (50) (50) (50)
Inflammation 1 (2%)
Intestine Large, Cecum (49) (50) (49) (47)
Inflammation, Chronic 1 (2%)
Intestine Small, Duodenum (50) (50) (50) (48)
Ectopic Tissue 1 (2%) 1 (2%)
Ulcer 1 (2%)
Intestine Small, Ileum (48) (50) (49) (48)
Hyperplasia, Lymphoid 1 (2%)
Liver (50) (50) (50) (50)
Basophilic Focus 5 (10%) 6 (12%) 8 (16%) 6 (12%)
Clear Cell Focus 14 (28%) 13 (26%) 16 (32%) 12 (24%)
Degeneration, Cystic 5 (10%) 3 (6%) 2 (4%) 1 (2%)
Eosinophilic Focus 5 (10%) 1 (2%) 4 (8%) 3 (6%)
Hepatodiaphragmatic Nodule 9 (18%) 2 (4%) 3 (6%) 4 (8%)
Inflammation, Chronic 1 (2%) 1 (2%)
Necrosis, Focal 1 (2%) 1 (2%)
Bile Duct, Hyperplasia 41 (82%) 35 (70%) 38 (76%) 37 (74%)
Centrilobular, Necrosis 2 (4%) 1 (2%) 2 (4%)
Hepatocyte, Vacuolization Cytoplasmic 5 (10%) 1 (2%) 2 (4%) 3 (6%)
Serosa, Inflammation 1 (2%)
Mesentery (16) (11) (9) (12)
Accessory Spleen 1 (8%)
Fibrosis 1 (6%)
Fat, Necrosis 14 (88%) 9 (82%) 8 (89%) 7 (58%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 7
NTP Experiment-Test: 91005-07 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC METHYLENE BLUE TRIHYDRATE Date: 03/25/05
Route: GAVAGE Time: 10:00:58
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 MG/KG 5 MG/KG 25 MG/KG 50 MG/KG
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Oral Mucosa (1) (4)
Pharyngeal, Cyst 2 (50%)
Pharyngeal, Inflammation 2 (50%)
Pancreas (50) (50) (50) (50)
Atrophy 43 (86%) 31 (62%) 35 (70%) 32 (64%)
Atrophy, Focal 1 (2%)
Cyst 1 (2%)
Inflammation, Chronic 1 (2%)
Acinus, Hyperplasia, Focal 4 (8%) 6 (12%) 15 (30%) 12 (24%)
Salivary Glands (50) (50) (50) (50)
Hyperplasia 1 (2%)
Stomach, Forestomach (50) (50) (50) (50)
Edema 6 (12%) 1 (2%) 2 (4%)
Erosion 3 (6%) 1 (2%)
Ulcer 4 (8%) 1 (2%) 2 (4%) 2 (4%)
Epithelium, Hyperplasia 4 (8%) 3 (6%) 3 (6%)
Stomach, Glandular (50) (50) (50) (50)
Edema 1 (2%) 2 (4%)
Erosion 4 (8%) 2 (4%) 1 (2%) 1 (2%)
Hyperplasia 1 (2%)
Inflammation 1 (2%)
Mineralization 1 (2%)
Ulcer 2 (4%) 1 (2%) 2 (4%) 1 (2%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (50) (50) (50) (50)
Cardiomyopathy 47 (94%) 46 (92%) 47 (94%) 45 (90%)
Mineralization 1 (2%)
Thrombosis 1 (2%) 1 (2%)
Pericardium, Inflammation, Granulomatous 1 (2%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (50) (50) (50) (50)
Accessory Adrenal Cortical Nodule 23 (46%) 23 (46%) 28 (56%) 25 (50%)
Degeneration, Fatty 7 (14%) 6 (12%) 7 (14%) 2 (4%)
Hyperplasia, Focal 6 (12%) 5 (10%) 5 (10%) 5 (10%)
Hypertrophy, Focal 6 (12%) 5 (10%) 9 (18%) 8 (16%)
Necrosis 1 (2%) 1 (2%)
Adrenal Medulla (50) (50) (50) (50)
a Number of animals examined microscopically at site and number of animals with lesion
Page 8
NTP Experiment-Test: 91005-07 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC METHYLENE BLUE TRIHYDRATE Date: 03/25/05
Route: GAVAGE Time: 10:00:58
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 MG/KG 5 MG/KG 25 MG/KG 50 MG/KG
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM - CONT
Hyperplasia 7 (14%) 12 (24%) 8 (16%) 2 (4%)
Thrombosis 1 (2%)
Islets, Pancreatic (50) (50) (50) (50)
Hyperplasia 13 (26%) 13 (26%) 17 (34%) 26 (52%)
Metaplasia, Hepatocyte 1 (2%)
Pituitary Gland (50) (50) (50) (50)
Pars Distalis, Angiectasis 14 (28%) 30 (60%) 16 (32%) 15 (30%)
Pars Distalis, Cyst 6 (12%) 3 (6%) 6 (12%) 5 (10%)
Pars Distalis, Hyperplasia, Focal 9 (18%) 8 (16%) 9 (18%) 13 (26%)
Pars Distalis, Hyperplasia, Multifocal 1 (2%)
Pars Intermedia, Cyst 1 (2%)
Thyroid Gland (50) (50) (50) (50)
Ultimobranchial Cyst 3 (6%) 1 (2%) 2 (4%)
C-Cell, Hyperplasia 8 (16%) 2 (4%) 9 (18%) 4 (8%)
Follicle, Cyst 1 (2%) 2 (4%) 4 (8%) 1 (2%)
Follicular Cell, Hyperplasia 1 (2%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Coagulating Gland (1) (2)
Inflammation 1 (50%)
Penis (1)
Fibrosis 1 (100%)
Preputial Gland (50) (50) (50) (50)
Cyst 4 (8%) 3 (6%)
Inflammation, Chronic 5 (10%) 5 (10%) 4 (8%) 4 (8%)
Prostate (50) (50) (50) (50)
Inflammation, Chronic 31 (62%) 28 (56%) 27 (54%) 26 (52%)
Testes (50) (50) (50) (50)
Bilateral, Germinal Epithelium, Atrophy 1 (2%) 2 (4%)
Germinal Epithelium, Atrophy 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (50) (50) (50) (50)
Hyperplasia 7 (14%) 7 (14%) 4 (8%) 9 (18%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 9
NTP Experiment-Test: 91005-07 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC METHYLENE BLUE TRIHYDRATE Date: 03/25/05
Route: GAVAGE Time: 10:00:58
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 MG/KG 5 MG/KG 25 MG/KG 50 MG/KG
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - CONT
Lymph Node (21) (17) (10) (18)
Deep Cervical, Hyperplasia, Lymphoid 1 (6%) 1 (10%)
Deep Cervical, Inflammation, Granulomatous 1 (5%)
Mediastinal, Hyperplasia, Lymphoid 9 (43%) 9 (53%) 10 (100%) 15 (83%)
Mediastinal, Inflammation, Granulomatous 1 (5%)
Pancreatic, Hyperplasia, Lymphoid 2 (10%) 4 (24%) 1 (10%) 1 (6%)
Lymph Node, Mesenteric (50) (50) (50) (50)
Hyperplasia, Lymphoid 7 (14%) 3 (6%) 4 (8%) 9 (18%)
Spleen (50) (50) (50) (50)
Fibrosis 1 (2%) 2 (4%) 2 (4%) 2 (4%)
Hematopoietic Cell Proliferation 11 (22%) 12 (24%) 17 (34%) 20 (40%)
Hemorrhage 2 (4%)
Necrosis 2 (4%)
Capsule, Fibrosis 1 (2%) 7 (14%) 12 (24%) 30 (60%)
Lymphoid Follicle, Hyperplasia 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (50) (50) (50) (50)
Cyst 23 (46%) 18 (36%) 20 (40%) 20 (40%)
Hyperplasia 1 (2%) 1 (2%)
Skin (50) (50) (50) (50)
Hyperkeratosis 1 (2%)
Inflammation, Chronic 5 (10%) 1 (2%)
Lip, Inflammation 1 (2%)
Subcutaneous Tissue, Mineralization 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (50) (50) (50) (50)
Cyst 1 (2%)
Cranium, Osteopetrosis 1 (2%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (50) (50) (50)
Compression 7 (14%) 10 (20%) 9 (18%) 6 (12%)
Hemorrhage 1 (2%) 2 (4%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 10
NTP Experiment-Test: 91005-07 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC METHYLENE BLUE TRIHYDRATE Date: 03/25/05
Route: GAVAGE Time: 10:00:58
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 MG/KG 5 MG/KG 25 MG/KG 50 MG/KG
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (50) (50) (50)
Congestion 3 (6%) 4 (8%) 3 (6%) 7 (14%)
Foreign Body 1 (2%) 2 (4%)
Hemorrhage 1 (2%)
Infiltration Cellular, Histiocyte 28 (56%) 29 (58%) 36 (72%) 26 (52%)
Inflammation, Chronic 29 (58%) 23 (46%) 36 (72%) 30 (60%)
Inflammation, Suppurative 1 (2%)
Necrosis 1 (2%) 1 (2%)
Alveolar Epithelium, Hyperplasia 7 (14%) 9 (18%) 4 (8%) 6 (12%)
Mediastinum, Inflammation, Granulomatous 1 (2%)
Nose (50) (50) (50) (50)
Foreign Body 7 (14%) 4 (8%) 12 (24%) 7 (14%)
Inflammation, Chronic 12 (24%) 3 (6%) 20 (40%) 15 (30%)
Pleura (1)
Inflammation, Granulomatous 1 (100%)
Trachea (50) (50) (50) (50)
Foreign Body 1 (2%)
Inflammation 1 (2%) 1 (2%)
Necrosis 1 (2%)
Perforation 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (50) (49) (48) (48)
Cataract 1 (2%) 3 (6%) 4 (8%) 3 (6%)
Inflammation, Chronic 1 (2%) 1 (2%) 1 (2%)
Phthisis Bulbi 1 (2%)
Anterior Chamber, Inflammation, Acute 1 (2%)
Bilateral, Anterior Chamber, Inflammation,
Acute 1 (2%)
Retina, Degeneration 1 (2%) 2 (4%) 4 (8%) 3 (6%)
Harderian Gland (50) (50) (50) (50)
Hyperplasia 1 (2%) 1 (2%)
Inflammation, Chronic 2 (4%) 3 (6%) 1 (2%) 4 (8%)
Pigmentation 2 (4%) 1 (2%) 1 (2%) 3 (6%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (50) (50) (50)
Cyst 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 11
NTP Experiment-Test: 91005-07 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC METHYLENE BLUE TRIHYDRATE Date: 03/25/05
Route: GAVAGE Time: 10:00:58
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 MG/KG 5 MG/KG 25 MG/KG 50 MG/KG
____________________________________________________________________________________________________________________________________
URINARY SYSTEM - CONT
Hydronephrosis 1 (2%) 2 (4%)
Infarct 2 (4%)
Nephropathy 35 (70%) 39 (78%) 33 (66%) 34 (68%)
Urethra (1)
Inflammation 1 (100%)
Urinary Bladder (50) (50) (50) (49)
Hemorrhage 1 (2%) 1 (2%)
Hyperplasia 1 (2%)
Inflammation, Chronic 2 (4%) 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 12
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