TDMS Study 91005-07 Pathology Tables
NTP Experiment-Test: 91005-07 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 03/25/05
Route: GAVAGE METHYLENE BLUE TRIHYDRATE Time: 10:16:58
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
b Average severity grade (1-minimal;2-mild;3-moderate;4-marked)
Page 1
NTP Experiment-Test: 91005-07 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 03/25/05
Route: GAVAGE METHYLENE BLUE TRIHYDRATE Time: 10:16:58
____________________________________________________________________________________________________________________________________
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 [3.0]
Intestine Large, Colon (50) (48) (49) (48)
Cyst 1 [4.0]
Intestine Small, Duodenum (49) (48) (49) (48)
Ectopic Tissue 1 [2.0]
Liver (50) (49) (50) (50)
Basophilic Focus 37 34 38 40
Clear Cell Focus 8 5 9 8
Degeneration, Cystic 1 [1.0] 1 [2.0] 1 [1.0]
Eosinophilic Focus 3 2
Hepatodiaphragmatic Nodule 7 [0.0] 4 [2.0] 7 [0.0] 4 [2.0]
Inflammation, Chronic 6 [2.0] 4 [1.8] 4 [1.8] 5 [1.8]
Necrosis, Focal 1 [2.0] 1 [1.0]
Bile Duct, Hyperplasia 7 [2.4] 5 [1.8] 6 [1.7] 2 [2.0]
Centrilobular, Necrosis 2 [1.5] 1 [2.0]
Hepatocyte, Vacuolization Cytoplasmic 4 [2.3] 4 [1.8]
Mesentery (17) (14) (12) (8)
Accessory Spleen 1 [2.0]
Fat, Necrosis 17 [2.8] 14 [2.6] 11 [2.6] 8 [2.4]
Oral Mucosa (2) (1)
Pharyngeal, Cyst 1 [3.0] 1 [2.0]
Pancreas (49) (48) (48) (49)
Atrophy 26 [1.5] 20 [1.4] 23 [1.3] 23 [1.5]
Inflammation 1 [1.0]
Acinus, Hyperplasia, Focal 3 [1.7] 1 [2.0] 2 [2.0] 1 [2.0]
Salivary Glands (50) (49) (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 2
NTP Experiment-Test: 91005-07 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 03/25/05
Route: GAVAGE METHYLENE BLUE TRIHYDRATE Time: 10:16:58
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 MG/KG 5 MG/KG 25 MG/KG 50 MG/KG
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Inflammation 1 [1.0]
Stomach, Forestomach (50) (49) (49) (49)
Edema 2 [2.5] 3 [2.3] 1 [3.0]
Erosion 1 [1.0]
Inflammation, Chronic Active 1 [1.0] 2 [1.0]
Ulcer 4 [2.3] 3 [3.0] 1 [3.0] 1 [2.0]
Epithelium, Hyperplasia 2 [2.0] 2 [2.0] 2 [1.5] 3 [1.3]
Stomach, Glandular (50) (49) (48) (49)
Edema 2 [2.0] 1 [2.0] 1 [2.0]
Erosion 2 [2.5] 2 [2.5]
Ulcer 2 [2.0] 1 [3.0] 1 [2.0]
Tongue (1) (1) (1) (1)
Cyst 1 [2.0]
Hyperplasia 1 [2.0] 1 [2.0]
Inflammation 1 [3.0]
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (50) (49) (50) (50)
Cardiomyopathy 36 [1.3] 41 [1.2] 36 [1.2] 32 [1.2]
Thrombosis 1 [2.0]
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (50) (49) (50) (50)
Accessory Adrenal Cortical Nodule 9 [1.3] 7 [1.3] 8 [1.3] 12 [1.3]
Degeneration, Fatty 11 [1.4] 13 [1.8] 13 [1.9] 8 [1.4]
Hyperplasia, Focal 5 [1.4] 8 [1.6] 8 [1.4] 6 [2.0]
Hypertrophy, Focal 12 [1.9] 11 [2.1] 13 [2.2] 7 [2.0]
Necrosis 2 [3.0] 1 [2.0]
Adrenal Medulla (50) (49) (50) (50)
Hyperplasia 1 [2.0] 2 [1.0] 1 [3.0]
Islets, Pancreatic (49) (48) (48) (49)
Hyperplasia 13 [1.0] 15 [1.0] 15 [1.1] 15 [1.0]
Metaplasia, Hepatocyte 2 [1.5]
Pituitary Gland (50) (49) (50) (50)
Pars Distalis, Angiectasis 28 [2.0] 27 [1.9] 29 [2.0] 21 [2.0]
Pars Distalis, Cyst 21 [2.1] 19 [1.6] 16 [1.7] 23 [2.0]
Pars Distalis, Hyperplasia, Focal 5 [2.0] 8 [1.8] 6 [2.0] 6 [1.8]
Pars Intermedia, Cyst 1 [2.0]
Thyroid Gland (50) (49) (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 3
NTP Experiment-Test: 91005-07 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 03/25/05
Route: GAVAGE METHYLENE BLUE TRIHYDRATE Time: 10:16:58
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 MG/KG 5 MG/KG 25 MG/KG 50 MG/KG
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM - CONT
Ultimobranchial Cyst 2 [1.5] 1 [1.0]
C-Cell, Hyperplasia 10 [2.1] 11 [1.4] 7 [1.9] 5 [2.0]
Follicle, Cyst 2 [2.0] 1 [1.0] 2 [1.0] 4 [2.0]
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Clitoral Gland (50) (48) (50) (50)
Cyst 4 [2.3] 7 [2.0] 4 [1.8] 6 [2.0]
Inflammation, Chronic 1 [2.0] 5 [1.6] 2 [3.0] 4 [2.3]
Ovary (50) (49) (50) (50)
Cyst 11 [1.9] 4 [1.8] 9 [2.0] 10 [1.8]
Uterus (50) (49) (50) (50)
Cyst 1 3 2 3
Hemorrhage 1 [2.0] 1 [3.0]
Hydrometra 1 [3.0] 4 [1.0] 2 [1.5] 1 [2.0]
Cervix, Cyst 1
Endometrium, Hyperplasia, Cystic 4 [2.5] 1 [1.0] 2 [2.0]
Vagina (1)
Cyst 1
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (50) (49) (50) (50)
Hyperplasia 8 [2.4] 8 [2.8] 9 [2.6] 6 [2.5]
Lymph Node (15) (8) (11) (3)
Mediastinal, Congestion 1 [3.0]
Mediastinal, Hyperplasia, Lymphoid 5 [2.0] 7 [2.1] 8 [2.0] 2 [2.0]
Pancreatic, Hyperplasia, Lymphoid 1 [2.0] 1 [2.0] 1 [2.0]
Lymph Node, Mesenteric (49) (49) (50) (50)
Hyperplasia, Lymphoid 1 [2.0] 1 [1.0]
Spleen (49) (48) (49) (49)
Fibrosis 2 [2.0]
Hematopoietic Cell Proliferation 3 [4.0] 5 [2.4] 7 [2.7] 8 [1.6]
Necrosis 1 [3.0]
Capsule, Fibrosis 8 [1.0] 17 [1.1] 12 [1.1] 20 [1.0]
Lymphoid Follicle, Atrophy 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 4
NTP Experiment-Test: 91005-07 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 03/25/05
Route: GAVAGE METHYLENE BLUE TRIHYDRATE Time: 10:16:58
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 MG/KG 5 MG/KG 25 MG/KG 50 MG/KG
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - CONT
Lymphoid Follicle, Hyperplasia 1 [3.0]
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (50) (49) (50) (50)
Cyst 2 [3.0] 1 [1.0]
Galactocele 1 1 1
Hyperplasia 18 [2.3] 19 [2.1] 9 [2.0] 7 [2.6]
Hyperplasia, Atypical 3 [1.3] 3 [2.0] 1 [2.0]
Duct, Dilatation 31 [2.6] 28 [2.5] 29 [2.4] 24 [2.4]
Duct, Hyperplasia 2 [2.0] 1 [2.0]
Skin (50) (49) (50) (50)
Inflammation, Chronic 2 [1.5]
Inflammation, Chronic Active 1 [4.0]
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (50) (49) (50) (50)
Inflammation 1 [4.0]
Cranium, Osteopetrosis 1 [2.0]
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (49) (50) (50)
Compression 3 [2.3] 8 [2.1] 6 [2.2] 5 [2.0]
Hemorrhage 1 [2.0] 1 [2.0] 1 [4.0]
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (49) (50) (50)
Congestion 5 [1.2] 2 [1.0] 5 [1.0] 8 [1.5]
Foreign Body 1 [3.0]
Infiltration Cellular, Histiocyte 41 [1.0] 37 [1.0] 39 [1.0] 38 [1.0]
Inflammation, Chronic 29 [1.0] 33 [1.0] 29 [1.0] 33 [1.0]
Inflammation, Suppurative 1 [3.0]
Necrosis 1 [3.0]
Alveolar Epithelium, Hyperplasia 1 [3.0] 4 [2.0] 3 [2.3] 2 [2.5]
Nose (50) (49) (50) (50)
Foreign Body 4 [1.8] 3 [1.0] 1 [1.0] 3 [1.7]
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: 91005-07 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 03/25/05
Route: GAVAGE METHYLENE BLUE TRIHYDRATE Time: 10:16:58
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 MG/KG 5 MG/KG 25 MG/KG 50 MG/KG
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM - CONT
Inflammation, Chronic 8 [1.9] 7 [1.0] 9 [1.8] 6 [1.7]
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (50) (49) (50) (50)
Cataract 1 [2.0] 2 [3.0] 5 [2.4] 3 [2.0]
Inflammation, Chronic 2 [4.0]
Anterior Chamber, Inflammation 1 [2.0]
Cornea, Inflammation, Chronic 1 [2.0] 1 [2.0] 2 [2.5]
Retina, Degeneration 2 [2.5] 2 [4.0] 4 [3.5] 2 [4.0]
Harderian Gland (50) (49) (50) (50)
Inflammation, Chronic 3 [1.7] 3 [1.3] 3 [1.3] 4 [1.0]
Pigmentation 2 [2.0] 2 [2.0] 1 [2.0] 1 [2.0]
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (49) (50) (50)
Cyst 1 [2.0] 1 [2.0]
Infarct 1 [2.0] 2 [1.5] 2 [2.0]
Nephropathy 14 [1.0] 15 [1.1] 21 [1.2] 16 [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 6
NTP Experiment-Test: 91005-07 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 03/25/05
Route: GAVAGE METHYLENE BLUE TRIHYDRATE Time: 10:16:58
____________________________________________________________________________________________________________________________________
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 [3.5]
Intestine Large, Colon (50) (50) (50) (50)
Inflammation 1 [2.0]
Intestine Large, Cecum (49) (50) (49) (47)
Inflammation, Chronic 1 [2.0]
Intestine Small, Duodenum (50) (50) (50) (48)
Ectopic Tissue 1 [2.0] 1 [2.0]
Ulcer 1 [2.0]
Intestine Small, Ileum (48) (50) (49) (48)
Hyperplasia, Lymphoid 1 [3.0]
Liver (50) (50) (50) (50)
Basophilic Focus 5 6 8 6
Clear Cell Focus 14 13 16 12
Degeneration, Cystic 5 [1.8] 3 [1.3] 2 [1.5] 1 [2.0]
Eosinophilic Focus 5 1 4 3
Hepatodiaphragmatic Nodule 9 [2.1] 2 [2.0] 3 [2.5] 4 [2.0]
Inflammation, Chronic 1 [1.0] 1 [1.0]
Necrosis, Focal 1 [2.0] 1 [1.0]
Bile Duct, Hyperplasia 41 [2.5] 35 [2.3] 38 [1.9] 37 [2.0]
Centrilobular, Necrosis 2 [1.5] 1 [2.0] 2 [2.0]
Hepatocyte, Vacuolization Cytoplasmic 5 [2.2] 1 [2.0] 2 [2.5] 3 [2.3]
Serosa, Inflammation 1 [2.0]
Mesentery (16) (11) (9) (12)
Accessory Spleen 1 [2.0]
Fibrosis 1 [2.0]
Fat, Necrosis 14 [2.6] 9 [2.3] 8 [3.0] 7 [2.6]
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 7
NTP Experiment-Test: 91005-07 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 03/25/05
Route: GAVAGE METHYLENE BLUE TRIHYDRATE Time: 10:16:58
____________________________________________________________________________________________________________________________________
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 [4.0]
Pharyngeal, Inflammation 2 [2.5]
Pancreas (50) (50) (50) (50)
Atrophy 43 [2.1] 31 [1.8] 35 [2.0] 32 [1.9]
Atrophy, Focal 1 [1.0]
Cyst 1 [2.0]
Inflammation, Chronic 1 [2.0]
Acinus, Hyperplasia, Focal 4 [2.0] 6 [1.7] 15 [1.9] 12 [1.8]
Salivary Glands (50) (50) (50) (50)
Hyperplasia 1 [2.0]
Stomach, Forestomach (50) (50) (50) (50)
Edema 6 [2.5] 1 [2.0] 2 [2.5]
Erosion 3 [2.3] 1 [1.0]
Ulcer 4 [3.5] 1 [2.0] 2 [2.5] 2 [2.5]
Epithelium, Hyperplasia 4 [2.3] 3 [1.7] 3 [1.3]
Stomach, Glandular (50) (50) (50) (50)
Edema 1 [2.0] 2 [2.0]
Erosion 4 [2.0] 2 [3.0] 1 [3.0] 1 [2.0]
Hyperplasia 1 [2.0]
Inflammation 1 [2.0]
Mineralization 1 [2.0]
Ulcer 2 [3.5] 1 [2.0] 2 [2.0] 1 [4.0]
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (50) (50) (50) (50)
Cardiomyopathy 47 [1.6] 46 [1.5] 47 [1.4] 45 [1.7]
Mineralization 1 [3.0]
Thrombosis 1 [2.0] 1 [1.0]
Pericardium, Inflammation, Granulomatous 1 [3.0]
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (50) (50) (50) (50)
Accessory Adrenal Cortical Nodule 23 [1.1] 23 [1.2] 28 [1.3] 25 [1.2]
Degeneration, Fatty 7 [1.9] 6 [1.3] 7 [1.7] 2 [1.5]
Hyperplasia, Focal 6 [1.2] 5 [1.6] 5 [1.6] 5 [1.2]
Hypertrophy, Focal 6 [2.3] 5 [1.6] 9 [1.9] 8 [2.0]
Necrosis 1 [2.0] 1 [3.0]
Adrenal Medulla (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 8
NTP Experiment-Test: 91005-07 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 03/25/05
Route: GAVAGE METHYLENE BLUE TRIHYDRATE Time: 10:16:58
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 MG/KG 5 MG/KG 25 MG/KG 50 MG/KG
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM - CONT
Hyperplasia 7 [2.0] 12 [1.8] 8 [1.6] 2 [2.0]
Thrombosis 1 [3.0]
Islets, Pancreatic (50) (50) (50) (50)
Hyperplasia 13 [1.2] 13 [1.7] 17 [1.8] 26 [1.4]
Metaplasia, Hepatocyte 1 [2.0]
Pituitary Gland (50) (50) (50) (50)
Pars Distalis, Angiectasis 14 [2.1] 30 [2.0] 16 [2.1] 15 [2.2]
Pars Distalis, Cyst 6 [2.4] 3 [1.3] 6 [1.8] 5 [2.0]
Pars Distalis, Hyperplasia, Focal 9 [2.1] 8 [2.0] 9 [1.8] 13 [2.3]
Pars Distalis, Hyperplasia, Multifocal 1 [3.0]
Pars Intermedia, Cyst 1 [1.0]
Thyroid Gland (50) (50) (50) (50)
Ultimobranchial Cyst 3 [1.7] 1 [1.0] 2 [1.5]
C-Cell, Hyperplasia 8 [2.4] 2 [2.0] 9 [1.8] 4 [2.3]
Follicle, Cyst 1 [1.0] 2 [2.0] 4 [1.0] 1 [1.0]
Follicular Cell, Hyperplasia 1 [3.0]
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Coagulating Gland (1) (2)
Inflammation 1 [4.0]
Penis (1)
Fibrosis 1 [2.0]
Preputial Gland (50) (50) (50) (50)
Cyst 4 [2.5] 3 [1.7]
Inflammation, Chronic 5 [2.0] 5 [1.4] 4 [2.0] 4 [1.8]
Prostate (50) (50) (50) (50)
Inflammation, Chronic 31 [2.0] 28 [1.8] 27 [2.0] 26 [2.1]
Testes (50) (50) (50) (50)
Bilateral, Germinal Epithelium, Atrophy 1 [4.0] 2 [3.0]
Germinal Epithelium, Atrophy 1 [1.0] 1 [3.0]
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (50) (50) (50) (50)
Hyperplasia 7 [2.4] 7 [2.9] 4 [2.5] 9 [2.7]
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: 91005-07 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 03/25/05
Route: GAVAGE METHYLENE BLUE TRIHYDRATE Time: 10:16:58
____________________________________________________________________________________________________________________________________
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 [3.0] 1 [4.0]
Deep Cervical, Inflammation, Granulomatous 1 [2.0]
Mediastinal, Hyperplasia, Lymphoid 9 [2.0] 9 [2.0] 10 [2.2] 15 [2.0]
Mediastinal, Inflammation, Granulomatous 1 [3.0]
Pancreatic, Hyperplasia, Lymphoid 2 [2.0] 4 [2.0] 1 [2.0] 1 [2.0]
Lymph Node, Mesenteric (50) (50) (50) (50)
Hyperplasia, Lymphoid 7 [2.3] 3 [2.0] 4 [2.0] 9 [2.1]
Spleen (50) (50) (50) (50)
Fibrosis 1 [2.0] 2 [1.5] 2 [2.0] 2 [2.0]
Hematopoietic Cell Proliferation 11 [1.5] 12 [2.0] 17 [1.5] 20 [1.7]
Hemorrhage 2 [2.5]
Necrosis 2 [3.0]
Capsule, Fibrosis 1 [1.0] 7 [1.3] 12 [1.5] 30 [1.8]
Lymphoid Follicle, Hyperplasia 1 [2.0] 1 [2.0]
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (50) (50) (50) (50)
Cyst 23 [1.8] 18 [1.7] 20 [1.8] 20 [1.9]
Hyperplasia 1 [2.0] 1 [1.0]
Skin (50) (50) (50) (50)
Hyperkeratosis 1 [2.0]
Inflammation, Chronic 5 [2.6] 1 [2.0]
Lip, Inflammation 1 [4.0]
Subcutaneous Tissue, Mineralization 1 [2.0]
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (50) (50) (50) (50)
Cyst 1
Cranium, Osteopetrosis 1 [2.0]
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (50) (50) (50)
Compression 7 [3.0] 10 [2.0] 9 [2.2] 6 [2.3]
Hemorrhage 1 [3.0] 2 [1.5]
____________________________________________________________________________________________________________________________________
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: 91005-07 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 03/25/05
Route: GAVAGE METHYLENE BLUE TRIHYDRATE Time: 10:16:58
____________________________________________________________________________________________________________________________________
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 [1.7] 4 [1.5] 3 [1.3] 7 [1.9]
Foreign Body 1 [2.0] 2 [2.0]
Hemorrhage 1 [2.0]
Infiltration Cellular, Histiocyte 28 [1.1] 29 [1.0] 36 [1.1] 26 [1.0]
Inflammation, Chronic 29 [1.1] 23 [1.0] 36 [1.0] 30 [1.2]
Inflammation, Suppurative 1 [3.0]
Necrosis 1 [3.0] 1 [2.0]
Alveolar Epithelium, Hyperplasia 7 [2.0] 9 [2.2] 4 [2.3] 6 [2.2]
Mediastinum, Inflammation, Granulomatous 1 [3.0]
Nose (50) (50) (50) (50)
Foreign Body 7 [2.0] 4 [1.0] 12 [1.7] 7 [1.7]
Inflammation, Chronic 12 [2.0] 3 [1.3] 20 [1.7] 15 [1.9]
Pleura (1)
Inflammation, Granulomatous 1 [3.0]
Trachea (50) (50) (50) (50)
Foreign Body 1 [2.0]
Inflammation 1 [3.0] 1 [2.0]
Necrosis 1 [2.0]
Perforation 1 [2.0]
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (50) (49) (48) (48)
Cataract 1 [2.0] 3 [2.7] 4 [2.8] 3 [2.7]
Inflammation, Chronic 1 [4.0] 1 [2.0] 1 [4.0]
Phthisis Bulbi 1
Anterior Chamber, Inflammation, Acute 1 [2.0]
Bilateral, Anterior Chamber, Inflammation,
Acute 1 [2.0]
Retina, Degeneration 1 [2.0] 2 [3.0] 4 [3.5] 3 [3.7]
Harderian Gland (50) (50) (50) (50)
Hyperplasia 1 [2.0] 1 [2.0]
Inflammation, Chronic 2 [2.0] 3 [1.0] 1 [1.0] 4 [1.0]
Pigmentation 2 [2.0] 1 [2.0] 1 [2.0] 3 [2.0]
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URINARY SYSTEM
Kidney (50) (50) (50) (50)
Cyst 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)
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NTP Experiment-Test: 91005-07 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 03/25/05
Route: GAVAGE METHYLENE BLUE TRIHYDRATE Time: 10:16:58
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FISCHER 344 RATS MALE 0 MG/KG 5 MG/KG 25 MG/KG 50 MG/KG
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URINARY SYSTEM - CONT
Hydronephrosis 1 [3.0] 2 [2.5]
Infarct 2 [1.5]
Nephropathy 35 [1.7] 39 [1.8] 33 [1.3] 34 [1.3]
Urethra (1)
Inflammation 1 [3.0]
Urinary Bladder (50) (50) (50) (49)
Hemorrhage 1 [2.0] 1 [2.0]
Hyperplasia 1 [3.0]
Inflammation, Chronic 2 [3.0] 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)
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