TDMS Study 93005-04 Pathology Tables
NTP Experiment-Test: 93005-04 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 MALACHITE GREEN Time: 07:29:07
Facility: National Center for Toxicological Research
Chemical CAS #: 569-64-2
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: 93005-04 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 MALACHITE GREEN Time: 07:29:07
____________________________________________________________________________________________________________________________________
C57BL/6N XC3H/HEN MTN-NCTR FEMALE 0 PPM 100 PPM 225 PPM 450 PPM
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DISPOSITION SUMMARY
Animals Initially In Study 48 48 48 48
Early Deaths
Natural Death 4 1 4 3
Accidently Killed 1
Moribund Sacrifice 4 3 3 4
Survivors
Terminal Sacrifice 40 44 40 41
Animals Examined Microscopically 48 48 48 48
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ALIMENTARY SYSTEM
Intestine Large, Cecum (46) (47) (45) (46)
Hyperplasia, Lymphoid 1 [2.0]
Intestine Small, Jejunum (46) (47) (44) (47)
Hyperplasia, Lymphoid 1 [4.0]
Liver (48) (48) (46) (48)
Basophilic Focus 1 1 3
Fatty Change, Focal 1 [2.0]
Hematopoietic Cell Proliferation 2 [1.0] 1 [2.0] 2 [1.0]
Infiltration Cellular, Lymphocyte 4 [1.0] 6 [1.3] 8 [1.6] 12 [1.2]
Infiltration Cellular, Histiocyte 1 [2.0]
Inflammation, Chronic Active, Focal 5 [1.4] 9 [1.1] 8 [1.0] 4 [1.0]
Necrosis 2 [2.5]
Tension Lipidosis 10 [1.2] 7 [1.3] 8 [1.5] 6 [1.5]
Bile Duct, Cyst 1 [3.0]
Mesentery (2) (5) (1)
Infiltration Cellular, Lymphocyte 1 [3.0]
Fat, Necrosis, Focal 2 [2.5] 3 [1.7] 1 [2.0]
Pancreas (47) (47) (44) (47)
Cyst 1 [2.0]
Cytoplasmic Alteration 1 [1.0] 1 [1.0] 1 [1.0]
Infiltration Cellular, Lymphocyte 6 [1.7] 4 [1.5] 2 [1.5] 3 [1.7]
Necrosis, Focal 1 [2.0]
Acinus, Atrophy 2 [2.5]
Salivary Glands (48) (48) (48) (48)
Infiltration Cellular, Mononuclear Cell 1 [1.0]
Parotid Gland, Infiltration Cellular,
Lymphocyte 5 [1.6] 12 [1.6] 4 [1.3] 5 [1.4]
Sublingual Gland, Infiltration Cellular,
Lymphocyte 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 2
NTP Experiment-Test: 93005-04 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 MALACHITE GREEN Time: 07:29:07
____________________________________________________________________________________________________________________________________
C57BL/6N XC3H/HEN MTN-NCTR FEMALE 0 PPM 100 PPM 225 PPM 450 PPM
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Submandibular Gland, Infiltration Cellular,
Lymphocyte 35 [1.5] 28 [1.6] 28 [1.8] 28 [1.8]
Stomach, Forestomach (47) (47) (46) (48)
Hyperkeratosis, Focal 1 [1.0]
Infiltration Cellular, Mast Cell 1 [2.0]
Inflammation, Chronic Active 2 [1.0] 3 [1.0] 2 [1.5] 1 [2.0]
Ulcer 1 [2.0]
Epithelium, Hyperplasia, Diffuse 2 [2.0] 2 [1.0] 1 [1.0]
Epithelium, Hyperplasia, Focal 11 [1.5] 8 [1.8] 4 [1.8] 7 [1.7]
Stomach, Glandular (47) (47) (46) (48)
Erosion 1 [2.0] 1 [2.0]
Ulcer 1 [2.0] 1 [2.0] 1 [1.0]
Tongue (48) (48) (48) (48)
Artery, Inflammation, Chronic 2 [2.0]
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CARDIOVASCULAR SYSTEM
Heart (48) (48) (48) (48)
Infiltration Cellular, Lymphocyte 2 [1.0]
Artery, Inflammation, Chronic 1 [2.0] 1 [3.0]
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ENDOCRINE SYSTEM
Adrenal Cortex (47) (47) (45) (47)
Accessory Adrenal Cortical Nodule 1 [1.0] 1 [1.0] 1 [1.0]
Hematopoietic Cell Proliferation 1 [1.0]
Hyperplasia, Focal 1 [1.0] 1 [1.0]
Hypertrophy, Focal 1 [2.0] 2 [2.5]
Mineralization, Focal 1 [4.0]
Vacuolization Cytoplasmic 1 [4.0]
Bilateral, Hypertrophy, Focal 1 [3.0]
Subcapsular, Hyperplasia 46 [1.9] 46 [2.0] 44 [1.9] 45 [2.0]
Adrenal Medulla (47) (46) (44) (46)
Hyperplasia, Focal 1 [1.0] 1 [1.0]
Pituitary Gland (48) (47) (46) (45)
Pars Distalis, Hyperplasia, Focal 1 [1.0] 2 [1.0] 5 [1.6]
Pars Intermedia, Hyperplasia, Focal 1 [2.0]
Thyroid Gland (47) (46) (46) (48)
Hyperplasia, Focal 1 [1.0]
Infiltration Cellular, Lymphocyte 1 [1.0] 1 [1.0]
Ultimobranchial Cyst 2 [1.0] 2 [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: 93005-04 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 MALACHITE GREEN Time: 07:29:07
____________________________________________________________________________________________________________________________________
C57BL/6N XC3H/HEN MTN-NCTR FEMALE 0 PPM 100 PPM 225 PPM 450 PPM
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM - CONT
Follicular Cell, Cyst 2 [1.0] 2 [1.0] 3 [1.0] 1 [1.0]
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GENERAL BODY SYSTEM
Tissue NOS (1) (1)
Hemorrhage 1 [4.0]
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GENITAL SYSTEM
Clitoral Gland (48) (47) (46) (44)
Inflammation, Chronic 1 [2.0]
Duct, Cyst 44 [1.9] 47 [1.9] 45 [2.0] 44 [1.9]
Ovary (48) (46) (46) (45)
Angiectasis 1 [2.0] 1 [3.0] 1 [2.0]
Atrophy 28 [2.1] 33 [2.3] 36 [2.5] 36 [2.6]
Cyst 15 [1.0] 18 [1.0] 11 [1.0] 11 [1.0]
Hemorrhage 3 [1.0] 1 [2.0] 1 [1.0]
Inflammation, Acute 1 [3.0]
Inflammation, Chronic Active 1 [3.0]
Mineralization 1 [2.0]
Thrombosis 1 [4.0]
Bilateral, Cyst 4 [1.0] 3 [1.0] 3 [1.0] 2 [1.0]
Germinal Epithelium, Hyperplasia 2 [2.0]
Uterus (48) (48) (47) (48)
Angiectasis 1 [2.0] 1 [2.0]
Hyperplasia, Cystic 42 [2.3] 46 [2.5] 44 [2.4] 42 [2.2]
Inflammation, Acute 1 [3.0]
Thrombosis 1 [2.0]
Vagina (48) (48) (46) (48)
Inflammation, Chronic 1 [2.0]
Artery, Inflammation, Chronic 1 [2.0]
Epithelium, Hyperplasia 1 [1.0]
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HEMATOPOIETIC SYSTEM
Bone Marrow (47) (47) (47) (48)
Fibrosis 1 [1.0]
Lymph Node (13) (13) (6) (9)
Inguinal, Hyperplasia, Lymphoid 1 [2.0]
Lumbar, Hyperplasia, Lymphoid 4 [2.0] 4 [2.0] 2 [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 4
NTP Experiment-Test: 93005-04 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 MALACHITE GREEN Time: 07:29:07
____________________________________________________________________________________________________________________________________
C57BL/6N XC3H/HEN MTN-NCTR FEMALE 0 PPM 100 PPM 225 PPM 450 PPM
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - CONT
Mediastinal, Hemorrhage 2 [2.0]
Mediastinal, Infiltration Cellular,
Mononuclear Cell 1 [2.0]
Pancreatic, Infiltration Cellular,
Mononuclear Cell 1 [3.0]
Renal, Hemorrhage 1 [3.0]
Renal, Hyperplasia, Lymphoid 2 [2.0] 1 [2.0] 2 [2.0] 1 [2.0]
Lymph Node, Mandibular (48) (48) (47) (48)
Hemorrhage 1 [2.0]
Hyperplasia, Lymphoid 2 [2.0] 1 [3.0] 2 [2.5] 1 [2.0]
Infiltration Cellular, Mast Cell 1 [2.0]
Lymph Node, Mesenteric (45) (46) (44) (46)
Hemorrhage 1 [1.0]
Hyperplasia, Lymphoid 8 [2.0] 8 [2.0] 5 [2.2] 5 [2.2]
Spleen (47) (47) (45) (47)
Angiectasis 1 [1.0] 1 [2.0]
Depletion Cellular 1 [2.0]
Hematopoietic Cell Proliferation 9 [2.4] 8 [2.5] 3 [2.0] 5 [3.0]
Hyperplasia, Lymphoid 6 [2.2] 6 [2.3] 7 [2.1] 2 [1.5]
Infiltration Cellular, Mononuclear Cell 1 [3.0]
Necrosis, Focal 1 [3.0]
Thymus (43) (44) (43) (47)
Angiectasis 1 [2.0]
Cyst 4 [1.0] 2 [1.0] 3 [1.0] 3 [1.0]
Ectopic Parathyroid Gland 3 [1.0] 1 [1.0] 2 [1.0] 3 [1.0]
Hyperplasia, Lymphoid 3 [1.3] 5 [2.2] 6 [2.3] 2 [2.5]
Infiltration Cellular, Mononuclear Cell 1 [3.0]
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INTEGUMENTARY SYSTEM
Mammary Gland (46) (48) (45) (46)
Infiltration Cellular, Lymphocyte 1 [2.0]
Skin (48) (48) (46) (48)
Fibrosis 1 [2.0]
Hyperplasia 1 [3.0]
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MUSCULOSKELETAL SYSTEM
Bone (48) (48) (48) (48)
Hyperostosis 1 [2.0]
Cranium, Fibrous Osteodystrophy 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: 93005-04 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 MALACHITE GREEN Time: 07:29:07
____________________________________________________________________________________________________________________________________
C57BL/6N XC3H/HEN MTN-NCTR FEMALE 0 PPM 100 PPM 225 PPM 450 PPM
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM - CONT
Femur, Fibrous Osteodystrophy 4 [2.0] 5 [1.2] 2 [2.0] 2 [2.0]
Sternum, Degeneration, Cystic 2 [1.0] 4 [1.3] 3 [1.0]
Sternum, Fibrous Osteodystrophy 12 [1.8] 14 [1.5] 5 [1.4] 5 [1.0]
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NERVOUS SYSTEM
Brain (48) (48) (48) (48)
Infiltration Cellular, Lymphocyte 1 [1.0]
Cerebrum, Mineralization 25 [1.0] 18 [1.0] 17 [1.0] 17 [1.0]
Spinal Cord (48) (48) (48) (48)
Thoracic, Axon, Degeneration 13 [1.2] 14 [1.1] 19 [1.2] 19 [1.1]
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RESPIRATORY SYSTEM
Lung (48) (48) (48) (48)
Hemorrhage, Focal 1 [2.0]
Infiltration Cellular, Lymphocyte 6 [1.7] 6 [1.8] 6 [1.7] 2 [1.5]
Infiltration Cellular, Histiocyte 2 [2.0] 3 [1.0] 2 [1.0]
Inflammation, Chronic, Focal 1 [1.0]
Pigmentation 1 [2.0]
Proteinosis 3 [2.0]
Thrombosis 1 [2.0]
Alveolar Epithelium, Hyperplasia 1 [1.0] 3 [1.3] 1 [1.0]
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SPECIAL SENSES SYSTEM
Eye (48) (48) (47) (48)
Bilateral, Lens, Cataract 4 [2.0] 2 [2.0] 5 [2.2] 2 [1.0]
Cornea, Mineralization 1 [3.0]
Lens, Cataract 1 [1.0] 2 [1.5] 1 [1.0] 6 [1.8]
Harderian Gland (48) (48) (48) (48)
Atrophy 1 [2.0]
Hyperplasia 1 [2.0] 1 [2.0]
Infiltration Cellular, Lymphocyte 4 [1.0] 5 [1.0] 5 [1.2] 4 [1.0]
Zymbal's Gland (48) (48) (47) (47)
Atrophy 1 [2.0] 1 [1.0]
Inflammation, Chronic 1 [4.0]
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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: 93005-04 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 MALACHITE GREEN Time: 07:29:07
____________________________________________________________________________________________________________________________________
C57BL/6N XC3H/HEN MTN-NCTR FEMALE 0 PPM 100 PPM 225 PPM 450 PPM
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (48) (47) (48) (47)
Infiltration Cellular, Lymphocyte 2 [1.5] 7 [1.4] 3 [1.0] 2 [1.5]
Metaplasia, Focal 1 [1.0]
Nephropathy 1 [1.0] 1 [1.0]
Glomerulus, Amyloid Deposition 2 [4.0]
Glomerulus, Casts Protein 1 [3.0] 1 [3.0]
Glomerulus, Hypertrophy 1 [2.0]
Glomerulus, Inflammation, Acute 1 [2.0]
Pelvis, Dilatation 2 [2.5]
Renal Tubule, Accumulation, Hyaline Droplet 4 [1.8] 1 [3.0] 1 [3.0]
Renal Tubule, Hyperplasia 1 [1.0]
Urinary Bladder (47) (46) (45) (48)
Inclusion Body Intracytoplasmic 7 [1.1] 15 [1.1] 34 [1.4] 39 [1.4]
Infiltration Cellular, Lymphocyte 36 [1.4] 34 [1.2] 33 [1.3] 25 [1.2]
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
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