TDMS Study 93029-04 Pathology Tables
NTP Experiment-Test: 93029-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 06/19/03
Route: DOSED FEED LEUKOMALACHITE GREEN Time: 07:13:27
Facility: National Center for Toxicological Research
Chemical CAS #: 129-73-7
Lock Date: None
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: 93029-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 06/19/03
Route: DOSED FEED LEUKOMALACHITE GREEN Time: 07:13:27
____________________________________________________________________________________________________________________________________
C57BL/6N XC3H/HEN MTN-NCTR FEMALE 0 PPM 91 PPM 204 PPM 408 PPM
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 48 48 48 48
Early Deaths
Natural Death 7 2 2 5
Moribund 4 5 7 4
Survivors
Terminal Sacrifice 37 41 39 39
Animals Examined Microscopically 47 48 47 47
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ALIMENTARY SYSTEM
Gallbladder (44) (47) (44) (46)
Infiltration Cellular, Lymphocytic 1 [2.0]
Inflammation, Acute 1 [2.0]
Polyarteritis 1 [1.0]
Mucosa, Hyperplasia, Focal 2 [1.0]
Intestine Large (46) (48) (47) (46)
Cecum, Polyarteritis 1 [2.0]
Colon, Angiectasis 1 [2.0]
Colon, Proliferation Connective Tissue 1 [2.0]
Rectum, Inflammation, Chronic 1 [3.0] 1 [2.0]
Rectum, Polyarteritis 1 [2.0]
Intestine Small (44) (47) (47) (46)
Ileum, Hyperplasia, Lymphoid 1 [2.0] 1 [1.0] 3 [1.7] 1 [4.0]
Jejunum, Hyperplasia, Lymphoid 2 [2.0] 1 [2.0]
Liver (47) (48) (47) (47)
Basophilic Focus 1 2 2
Basophilic Focus, Two 1
Clear Cell Focus 1 1
Eosinophilic Focus, Single 1 1
Hematopoietic Cell Proliferation 2 [1.5] 2 [3.0] 3 [2.3] 3 [2.0]
Infarct 1 [4.0]
Infiltration Cellular, Lymphocytic 8 [1.5] 2 [1.5] 2 [2.0] 8 [1.3]
Inflammation, Chronic Active, Focal 15 [1.4] 13 [1.3] 16 [1.1] 11 [1.3]
Leukocytosis 1 [2.0]
Mineralization, Focal 1 [1.0]
Necrosis 1 [2.0]
Tension Lipidosis 10 [1.6] 12 [1.1] 9 [1.3] 9 [1.2]
Vacuolization Cytoplasmic 2 [2.0] 1 [1.0]
Bile Duct, Cyst 3 [2.3] 1 [2.0] 1 [2.0] 1 [2.0]
Oval Cell, Hyperplasia 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: 93029-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 06/19/03
Route: DOSED FEED LEUKOMALACHITE GREEN Time: 07:13:27
____________________________________________________________________________________________________________________________________
C57BL/6N XC3H/HEN MTN-NCTR FEMALE 0 PPM 91 PPM 204 PPM 408 PPM
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Serosa, Fibrosis 1 [2.0]
Mesentery (1) (2) (1) (3)
Fat, Necrosis, Focal 1 [2.0] 2 [2.0] 1 [1.0] 3 [2.0]
Pancreas (45) (48) (47) (45)
Cyst 2 [2.0]
Cytoplasmic Alteration 1 [1.0] 1 [1.0] 1 [1.0] 2 [1.5]
Infiltration Cellular, Lymphocytic 7 [1.4] 9 [1.1] 4 [1.0] 6 [1.2]
Polyarteritis 1 [3.0]
Acinus, Atrophy 1 [1.0] 2 [2.0] 1 [1.0] 2 [3.0]
Salivary Glands (47) (48) (47) (47)
Acinus, Parotid Gland, Atrophy 1 [1.0] 3 [2.7] 1 [3.0]
Acinus, Parotid Gland, Necrosis, Focal 3 [1.3] 2 [1.0]
Acinus, Submandibular Gland, Atrophy 1 [2.0] 1 [3.0] 1 [3.0]
Parotid Gland, Infiltration Cellular,
Lymphocytic 9 [1.2] 9 [1.1] 8 [1.5] 11 [1.4]
Parotid Gland, Vacuolization Cytoplasmic 2 [2.0] 1 [2.0]
Sublingual Gland, Infiltration Cellular,
Lymphocytic 2 [1.0] 1 [1.0]
Submandibular Gland, Infiltration Cellular,
Lymphocytic 33 [1.6] 30 [1.5] 35 [1.6] 31 [1.5]
Stomach (46) (48) (47) (46)
Forestomach, Foreign Body 1 [2.0]
Forestomach, Hyperkeratosis, Focal 1 [1.0]
Forestomach, Infiltration Cellular,
Lymphocytic 1 [2.0]
Forestomach, Inflammation, Chronic Active 2 [2.0]
Forestomach, Epithelium, Hyperplasia, Diffuse 1 [3.0]
Forestomach, Epithelium, Hyperplasia, Focal 3 [2.0] 4 [1.5] 8 [2.3] 6 [1.5]
Glandular, Infiltration Cellular, Lymphocytic 1 [2.0] 2 [2.0] 1 [1.0]
Glandular, Polyarteritis 1 [2.0]
Glandular, Ulcer 1 [2.0]
Tongue (47) (48) (47) (47)
Foreign Body 3 [1.0] 1 [1.0] 3 [1.0]
Artery, Inflammation, Chronic 1 [2.0] 2 [2.0] 2 [2.0]
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Blood Vessel (47) (48) (46) (46)
Aorta, Embolus Bacterial 1 [4.0]
Heart (47) (48) (47) (47)
Cardiomyopathy 1 [1.0]
Inflammation, Acute, Focal 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 3
NTP Experiment-Test: 93029-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 06/19/03
Route: DOSED FEED LEUKOMALACHITE GREEN Time: 07:13:27
____________________________________________________________________________________________________________________________________
C57BL/6N XC3H/HEN MTN-NCTR FEMALE 0 PPM 91 PPM 204 PPM 408 PPM
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM - CONT
Mineralization 1 [1.0]
Polyarteritis 1 [3.0]
Atrium Left, Thrombosis 1 [3.0]
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ENDOCRINE SYSTEM
Adrenal Gland (46) (48) (47) (47)
Bilateral, Cortex, Hypertrophy, Focal 1 [2.0]
Cortex, Accessory Adrenal Cortical Nodule 3 1 1 1
Cortex, Cyst 1
Cortex, Hematopoietic Cell Proliferation 1 [1.0] 1 [3.0]
Cortex, Hyperplasia, Focal 2 [1.0] 2 [2.0]
Cortex, Hypertrophy, Focal 2 [1.5] 2 [2.0] 1 [3.0]
Cortex, Polyarteritis 1 [3.0]
Cortex, Subcapsular, Hyperplasia 42 [1.9] 47 [1.9] 46 [1.8] 47 [1.9]
Medulla, Hyperplasia, Focal 1 [1.0]
Parathyroid Gland (42) (42) (41) (44)
Infiltration Cellular, Lymphocytic 1 [3.0]
Pituitary Gland (41) (45) (44) (46)
Pars Distalis, Hyperplasia, Focal 3 [1.3] 1 [1.0] 3 [1.3] 2 [2.5]
Thyroid Gland (46) (48) (47) (47)
Ectopic Thymus 1
Polyarteritis 1 [3.0]
Ultimobranchial Cyst 2 2
Follicular Cell, Cyst 7 [1.7] 10 [1.5] 6 [1.0] 9 [1.3]
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GENERAL BODY SYSTEM
None
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GENITAL SYSTEM
Clitoral Gland (45) (46) (44) (45)
Inflammation, Chronic 1 [2.0]
Inflammation, Subacute 1 [2.0]
Duct, Cyst 44 [1.9] 46 [1.9] 41 [1.9] 45 [1.8]
Ovary (46) (48) (47) (44)
Abscess 1
Angiectasis 1 [2.0] 1 [2.0] 2 [2.0]
Atrophy 42 [1.9] 45 [1.7] 44 [1.9] 41 [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 4
NTP Experiment-Test: 93029-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 06/19/03
Route: DOSED FEED LEUKOMALACHITE GREEN Time: 07:13:27
____________________________________________________________________________________________________________________________________
C57BL/6N XC3H/HEN MTN-NCTR FEMALE 0 PPM 91 PPM 204 PPM 408 PPM
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM - CONT
Cyst 14 16 17 10
Hemorrhage 4 [1.8] 2 [2.0] 2 [1.0] 2 [1.0]
Mineralization 1 [1.0]
Thrombosis 3 [3.0]
Bilateral, Cyst 7 3 2 3
Uterus (46) (48) (47) (46)
Adenomyosis, Focal 1 [3.0]
Angiectasis 4 [1.8] 3 [1.3] 1 [1.0]
Hyperplasia, Cystic 42 [2.4] 46 [2.6] 47 [2.4] 43 [2.5]
Inflammation, Acute 1 [3.0]
Polyarteritis 1 [2.0]
Thrombosis 1 [4.0] 3 [2.3]
Endometrium, Metaplasia 1 [2.0]
Stroma, Fibrosis 1 [3.0]
Stroma, Hyperplasia 1 [3.0]
Vagina (45) (47) (47) (46)
Epithelium, Hyperplasia 1 [2.0] 3 [1.7]
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HEMATOPOIETIC SYSTEM
Bone Marrow (46) (48) (47) (46)
Angiectasis, Focal 1 [2.0]
Fibrosis 1 [3.0] 1 [3.0]
Femoral, Infarct 1 [2.0]
Myeloid Cell, Hyperplasia 4 [2.3] 1 [2.0] 4 [3.0] 6 [2.2]
Lymph Node (47) (48) (47) (47)
Inguinal, Hyperplasia, Lymphoid 1 [1.0]
Lumbar, Cyst 1
Lumbar, Hematopoietic Cell Proliferation 1 [3.0]
Lumbar, Hyperplasia, Lymphoid 1 [3.0]
Lumbar, Hyperplasia, Plasma Cell 1 [3.0]
Mandibular, Hyperplasia, Lymphoid 1 [2.0] 3 [2.7] 8 [2.6] 2 [2.0]
Mediastinal, Hyperplasia, Lymphoid 1 [2.0]
Mesenteric, Hematopoietic Cell Proliferation 1 [2.0] 1 [2.0]
Mesenteric, Hemorrhage 1 [1.0] 1 [2.0] 1 [2.0] 1 [1.0]
Mesenteric, Hyperplasia, Lymphoid 5 [2.2] 2 [2.0] 3 [2.7] 6 [2.7]
Mesenteric, Infiltration Cellular, Plasma
Cell 2 [3.0] 1 [4.0]
Renal, Hyperplasia, Lymphoid 2 [2.5]
Thoracic, Hyperplasia, Plasma Cell 1 [3.0]
Spleen (45) (48) (47) (45)
Angiectasis 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 5
NTP Experiment-Test: 93029-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 06/19/03
Route: DOSED FEED LEUKOMALACHITE GREEN Time: 07:13:27
____________________________________________________________________________________________________________________________________
C57BL/6N XC3H/HEN MTN-NCTR FEMALE 0 PPM 91 PPM 204 PPM 408 PPM
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - CONT
Hematopoietic Cell Proliferation 11 [2.5] 9 [2.6] 17 [2.1] 17 [2.2]
Hyperplasia, Lymphoid 14 [2.1] 4 [1.8] 8 [2.1] 9 [2.1]
Infiltration Cellular, Plasma Cell 1 [4.0] 1 [4.0]
Proliferation Connective Tissue, Focal 1 [1.0]
Thymus (43) (45) (45) (43)
Atrophy 2 [2.0] 2 [2.5] 1 [2.0]
Cyst 2 1 2 2
Ectopic Parathyroid Gland 4 7 4 7
Hyperplasia, Lymphoid 2 [1.5] 3 [1.3] 5 [2.0] 6 [1.8]
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INTEGUMENTARY SYSTEM
Mammary Gland (46) (48) (47) (45)
Infiltration Cellular, Lymphocytic 1 [2.0]
Skin (46) (48) (45) (45)
Face, Ulcer 1 [3.0]
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MUSCULOSKELETAL SYSTEM
Bone (47) (48) (47) (47)
Femur, Fibrous Osteodystrophy 8 [1.4] 2 [1.0] 5 [1.6] 3 [1.0]
Sternum, Degeneration, Cystic 1 [1.0] 3 [1.0] 1 [1.0] 5 [1.0]
Sternum, Fibrous Osteodystrophy 26 [1.4] 21 [1.4] 19 [1.4] 21 [1.2]
Skeletal Muscle (47) (48) (47) (46)
Mineralization 2 [2.0]
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NERVOUS SYSTEM
Brain (47) (48) (47) (47)
Cerebellum, Infiltration Cellular,
Lymphocytic 1 [2.0]
Cerebrum, Mineralization 15 [1.0] 18 [1.0] 21 [1.0] 21 [1.0]
Cerebrum, Polyarteritis 1 [1.0]
Spinal Cord (47) (48) (47) (47)
Thoracic, Infiltration Cellular, Lymphocytic 1 [1.0]
Thoracic, Axon, Degeneration 12 [1.0] 11 [1.2] 9 [1.0] 14 [1.2]
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RESPIRATORY 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: 93029-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 06/19/03
Route: DOSED FEED LEUKOMALACHITE GREEN Time: 07:13:27
____________________________________________________________________________________________________________________________________
C57BL/6N XC3H/HEN MTN-NCTR FEMALE 0 PPM 91 PPM 204 PPM 408 PPM
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM - CONT
Lung (47) (48) (47) (47)
Crystals 1 [2.0] 1 [3.0]
Hemorrhage, Focal 1 [2.0]
Infarct 1 [2.0]
Infiltration Cellular, Histiocytic 1 [1.0] 2 [1.0] 2 [1.0]
Infiltration Cellular, Lymphocytic 13 [1.8] 7 [1.7] 9 [1.8] 12 [1.5]
Inflammation, Chronic, Focal 1 [1.0] 1 [1.0] 1 [1.0]
Inflammation, Granulomatous 1 [2.0]
Leukocytosis 2 [2.0] 1 [4.0]
Alveolar Epithelium, Hyperplasia 1 [1.0] 1 [1.0] 1 [1.0] 1 [1.0]
Artery, Mineralization 1 [1.0]
Vein, Thrombosis 1 [3.0]
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SPECIAL SENSES SYSTEM
Eye (47) (48) (47) (47)
Phthisis Bulbi 1
Bilateral, Lens, Cataract 4 [3.3] 5 [2.0] 3 [2.3] 7 [2.4]
Conjunctiva, Polyarteritis 1 [2.0]
Cornea, Inflammation, Chronic 1 [2.0]
Lens, Cataract 5 [1.8] 4 [1.8] 4 [2.0] 4 [1.8]
Harderian Gland (47) (48) (47) (47)
Atrophy 1 [1.0]
Hyperplasia 1 [2.0] 1 [2.0] 3 [1.7]
Infiltration Cellular, Lymphocytic 4 [1.3] 9 [1.6] 8 [1.1] 5 [1.0]
Acinus, Dilatation 1 [2.0]
Zymbal's Gland (47) (47) (46) (47)
Atrophy 1 [2.0] 1 [2.0]
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URINARY SYSTEM
Kidney (47) (48) (47) (47)
Glomerulosclerosis 1 [1.0] 1 [1.0]
Hematopoietic Cell Proliferation 1 [2.0]
Infarct 2 [1.0] 1 [1.0] 1 [1.0]
Infiltration Cellular, Lymphocytic 9 [1.4] 5 [1.0] 15 [1.1] 11 [1.3]
Nephropathy 1 [3.0] 2 [1.0] 3 [1.0] 1 [1.0]
Polyarteritis 1 [3.0]
Glomerulus, Casts Protein 1 [2.0] 1 [3.0]
Papilla, Casts Protein 1 [1.0]
Pelvis, Dilatation 2 [3.5] 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 7
NTP Experiment-Test: 93029-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 06/19/03
Route: DOSED FEED LEUKOMALACHITE GREEN Time: 07:13:27
____________________________________________________________________________________________________________________________________
C57BL/6N XC3H/HEN MTN-NCTR FEMALE 0 PPM 91 PPM 204 PPM 408 PPM
____________________________________________________________________________________________________________________________________
URINARY SYSTEM - CONT
Renal Tubule, Accumulation, Hyaline Droplet 1 [3.0] 2 [2.5] 1 [2.0] 3 [2.3]
Renal Tubule, Hyperplasia 1 [2.0]
Renal Tubule, Hypertrophy 1 [1.0]
Renal Tubule, Necrosis 1 [2.0]
Renal Tubule, Pigmentation 1 [2.0]
Urinary Bladder (46) (48) (47) (44)
Inclusion Body Intracytoplasmic 14 [1.0] 33 [1.2] 44 [1.9] 44 [2.9]
Infiltration Cellular, Lymphocytic 29 [1.4] 22 [1.1] 24 [1.2] 26 [1.3]
Polyarteritis 1 [1.0]
Submucosa, Edema 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 8
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