TDMS Study 93029-04 Pathology Tables
NTP Experiment-Test: 93029-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC LEUKOMALACHITE GREEN Date: 06/19/03
Route: DOSED FEED Time: 07:04:42
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
Page 1
NTP Experiment-Test: 93029-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC LEUKOMALACHITE GREEN Date: 06/19/03
Route: DOSED FEED Time: 07:04:42
____________________________________________________________________________________________________________________________________
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%)
Inflammation, Acute 1 (2%)
Polyarteritis 1 (2%)
Mucosa, Hyperplasia, Focal 2 (4%)
Intestine Large (46) (48) (47) (46)
Cecum, Polyarteritis 1 (2%)
Colon, Angiectasis 1 (2%)
Colon, Proliferation Connective Tissue 1 (2%)
Rectum, Inflammation, Chronic 1 (2%) 1 (2%)
Rectum, Polyarteritis 1 (2%)
Intestine Small (44) (47) (47) (46)
Ileum, Hyperplasia, Lymphoid 1 (2%) 1 (2%) 3 (6%) 1 (2%)
Jejunum, Hyperplasia, Lymphoid 2 (4%) 1 (2%)
Liver (47) (48) (47) (47)
Basophilic Focus 1 (2%) 2 (4%) 2 (4%)
Basophilic Focus, Two 1 (2%)
Clear Cell Focus 1 (2%) 1 (2%)
Eosinophilic Focus, Single 1 (2%) 1 (2%)
Hematopoietic Cell Proliferation 2 (4%) 2 (4%) 3 (6%) 3 (6%)
Infarct 1 (2%)
Infiltration Cellular, Lymphocytic 8 (17%) 2 (4%) 2 (4%) 8 (17%)
Inflammation, Chronic Active, Focal 15 (32%) 13 (27%) 16 (34%) 11 (23%)
Leukocytosis 1 (2%)
Mineralization, Focal 1 (2%)
Necrosis 1 (2%)
Tension Lipidosis 10 (21%) 12 (25%) 9 (19%) 9 (19%)
Vacuolization Cytoplasmic 2 (4%) 1 (2%)
Bile Duct, Cyst 3 (6%) 1 (2%) 1 (2%) 1 (2%)
Oval Cell, Hyperplasia 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 2
NTP Experiment-Test: 93029-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC LEUKOMALACHITE GREEN Date: 06/19/03
Route: DOSED FEED Time: 07:04:42
____________________________________________________________________________________________________________________________________
C57BL/6N XC3H/HEN MTN-NCTR FEMALE 0 PPM 91 PPM 204 PPM 408 PPM
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Serosa, Fibrosis 1 (2%)
Mesentery (1) (2) (1) (3)
Fat, Necrosis, Focal 1 (100%) 2 (100%) 1 (100%) 3 (100%)
Pancreas (45) (48) (47) (45)
Cyst 2 (4%)
Cytoplasmic Alteration 1 (2%) 1 (2%) 1 (2%) 2 (4%)
Infiltration Cellular, Lymphocytic 7 (16%) 9 (19%) 4 (9%) 6 (13%)
Polyarteritis 1 (2%)
Acinus, Atrophy 1 (2%) 2 (4%) 1 (2%) 2 (4%)
Salivary Glands (47) (48) (47) (47)
Acinus, Parotid Gland, Atrophy 1 (2%) 3 (6%) 1 (2%)
Acinus, Parotid Gland, Necrosis, Focal 3 (6%) 2 (4%)
Acinus, Submandibular Gland, Atrophy 1 (2%) 1 (2%) 1 (2%)
Parotid Gland, Infiltration Cellular,
Lymphocytic 9 (19%) 9 (19%) 8 (17%) 11 (23%)
Parotid Gland, Vacuolization Cytoplasmic 2 (4%) 1 (2%)
Sublingual Gland, Infiltration Cellular,
Lymphocytic 2 (4%) 1 (2%)
Submandibular Gland, Infiltration Cellular,
Lymphocytic 33 (70%) 30 (63%) 35 (74%) 31 (66%)
Stomach (46) (48) (47) (46)
Forestomach, Foreign Body 1 (2%)
Forestomach, Hyperkeratosis, Focal 1 (2%)
Forestomach, Infiltration Cellular,
Lymphocytic 1 (2%)
Forestomach, Inflammation, Chronic Active 2 (4%)
Forestomach, Epithelium, Hyperplasia, Diffuse 1 (2%)
Forestomach, Epithelium, Hyperplasia, Focal 3 (7%) 4 (8%) 8 (17%) 6 (13%)
Glandular, Infiltration Cellular, Lymphocytic 1 (2%) 2 (4%) 1 (2%)
Glandular, Polyarteritis 1 (2%)
Glandular, Ulcer 1 (2%)
Tongue (47) (48) (47) (47)
Foreign Body 3 (6%) 1 (2%) 3 (6%)
Artery, Inflammation, Chronic 1 (2%) 2 (4%) 2 (4%)
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CARDIOVASCULAR SYSTEM
Blood Vessel (47) (48) (46) (46)
Aorta, Embolus Bacterial 1 (2%)
Heart (47) (48) (47) (47)
Cardiomyopathy 1 (2%)
Inflammation, Acute, Focal 1 (2%) 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 3
NTP Experiment-Test: 93029-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC LEUKOMALACHITE GREEN Date: 06/19/03
Route: DOSED FEED Time: 07:04:42
____________________________________________________________________________________________________________________________________
C57BL/6N XC3H/HEN MTN-NCTR FEMALE 0 PPM 91 PPM 204 PPM 408 PPM
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM - CONT
Mineralization 1 (2%)
Polyarteritis 1 (2%)
Atrium Left, Thrombosis 1 (2%)
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ENDOCRINE SYSTEM
Adrenal Gland (46) (48) (47) (47)
Bilateral, Cortex, Hypertrophy, Focal 1 (2%)
Cortex, Accessory Adrenal Cortical Nodule 3 (7%) 1 (2%) 1 (2%) 1 (2%)
Cortex, Cyst 1 (2%)
Cortex, Hematopoietic Cell Proliferation 1 (2%) 1 (2%)
Cortex, Hyperplasia, Focal 2 (4%) 2 (4%)
Cortex, Hypertrophy, Focal 2 (4%) 2 (4%) 1 (2%)
Cortex, Polyarteritis 1 (2%)
Cortex, Subcapsular, Hyperplasia 42 (91%) 47 (98%) 46 (98%) 47 (100%)
Medulla, Hyperplasia, Focal 1 (2%)
Parathyroid Gland (42) (42) (41) (44)
Infiltration Cellular, Lymphocytic 1 (2%)
Pituitary Gland (41) (45) (44) (46)
Pars Distalis, Hyperplasia, Focal 3 (7%) 1 (2%) 3 (7%) 2 (4%)
Thyroid Gland (46) (48) (47) (47)
Ectopic Thymus 1 (2%)
Polyarteritis 1 (2%)
Ultimobranchial Cyst 2 (4%) 2 (4%)
Follicular Cell, Cyst 7 (15%) 10 (21%) 6 (13%) 9 (19%)
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GENERAL BODY SYSTEM
None
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GENITAL SYSTEM
Clitoral Gland (45) (46) (44) (45)
Inflammation, Chronic 1 (2%)
Inflammation, Subacute 1 (2%)
Duct, Cyst 44 (98%) 46 (100%) 41 (93%) 45 (100%)
Ovary (46) (48) (47) (44)
Abscess 1 (2%)
Angiectasis 1 (2%) 1 (2%) 2 (4%)
Atrophy 42 (91%) 45 (94%) 44 (94%) 41 (93%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 4
NTP Experiment-Test: 93029-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC LEUKOMALACHITE GREEN Date: 06/19/03
Route: DOSED FEED Time: 07:04:42
____________________________________________________________________________________________________________________________________
C57BL/6N XC3H/HEN MTN-NCTR FEMALE 0 PPM 91 PPM 204 PPM 408 PPM
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM - CONT
Cyst 14 (30%) 16 (33%) 17 (36%) 10 (23%)
Hemorrhage 4 (9%) 2 (4%) 2 (4%) 2 (5%)
Mineralization 1 (2%)
Thrombosis 3 (7%)
Bilateral, Cyst 7 (15%) 3 (6%) 2 (4%) 3 (7%)
Uterus (46) (48) (47) (46)
Adenomyosis, Focal 1 (2%)
Angiectasis 4 (8%) 3 (6%) 1 (2%)
Hyperplasia, Cystic 42 (91%) 46 (96%) 47 (100%) 43 (93%)
Inflammation, Acute 1 (2%)
Polyarteritis 1 (2%)
Thrombosis 1 (2%) 3 (6%)
Endometrium, Metaplasia 1 (2%)
Stroma, Fibrosis 1 (2%)
Stroma, Hyperplasia 1 (2%)
Vagina (45) (47) (47) (46)
Epithelium, Hyperplasia 1 (2%) 3 (7%)
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HEMATOPOIETIC SYSTEM
Bone Marrow (46) (48) (47) (46)
Angiectasis, Focal 1 (2%)
Fibrosis 1 (2%) 1 (2%)
Femoral, Infarct 1 (2%)
Myeloid Cell, Hyperplasia 4 (9%) 1 (2%) 4 (9%) 6 (13%)
Lymph Node (47) (48) (47) (47)
Inguinal, Hyperplasia, Lymphoid 1 (2%)
Lumbar, Cyst 1 (2%)
Lumbar, Hematopoietic Cell Proliferation 1 (2%)
Lumbar, Hyperplasia, Lymphoid 1 (2%)
Lumbar, Hyperplasia, Plasma Cell 1 (2%)
Mandibular, Hyperplasia, Lymphoid 1 (2%) 3 (6%) 8 (17%) 2 (4%)
Mediastinal, Hyperplasia, Lymphoid 1 (2%)
Mesenteric, Hematopoietic Cell Proliferation 1 (2%) 1 (2%)
Mesenteric, Hemorrhage 1 (2%) 1 (2%) 1 (2%) 1 (2%)
Mesenteric, Hyperplasia, Lymphoid 5 (11%) 2 (4%) 3 (6%) 6 (13%)
Mesenteric, Infiltration Cellular, Plasma
Cell 2 (4%) 1 (2%)
Renal, Hyperplasia, Lymphoid 2 (4%)
Thoracic, Hyperplasia, Plasma Cell 1 (2%)
Spleen (45) (48) (47) (45)
Angiectasis 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 5
NTP Experiment-Test: 93029-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC LEUKOMALACHITE GREEN Date: 06/19/03
Route: DOSED FEED Time: 07:04:42
____________________________________________________________________________________________________________________________________
C57BL/6N XC3H/HEN MTN-NCTR FEMALE 0 PPM 91 PPM 204 PPM 408 PPM
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - CONT
Hematopoietic Cell Proliferation 11 (24%) 9 (19%) 17 (36%) 17 (38%)
Hyperplasia, Lymphoid 14 (31%) 4 (8%) 8 (17%) 9 (20%)
Infiltration Cellular, Plasma Cell 1 (2%) 1 (2%)
Proliferation Connective Tissue, Focal 1 (2%)
Thymus (43) (45) (45) (43)
Atrophy 2 (5%) 2 (4%) 1 (2%)
Cyst 2 (5%) 1 (2%) 2 (4%) 2 (5%)
Ectopic Parathyroid Gland 4 (9%) 7 (16%) 4 (9%) 7 (16%)
Hyperplasia, Lymphoid 2 (5%) 3 (7%) 5 (11%) 6 (14%)
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INTEGUMENTARY SYSTEM
Mammary Gland (46) (48) (47) (45)
Infiltration Cellular, Lymphocytic 1 (2%)
Skin (46) (48) (45) (45)
Face, Ulcer 1 (2%)
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MUSCULOSKELETAL SYSTEM
Bone (47) (48) (47) (47)
Femur, Fibrous Osteodystrophy 8 (17%) 2 (4%) 5 (11%) 3 (6%)
Sternum, Degeneration, Cystic 1 (2%) 3 (6%) 1 (2%) 5 (11%)
Sternum, Fibrous Osteodystrophy 26 (55%) 21 (44%) 19 (40%) 21 (45%)
Skeletal Muscle (47) (48) (47) (46)
Mineralization 2 (4%)
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NERVOUS SYSTEM
Brain (47) (48) (47) (47)
Cerebellum, Infiltration Cellular,
Lymphocytic 1 (2%)
Cerebrum, Mineralization 15 (32%) 18 (38%) 21 (45%) 21 (45%)
Cerebrum, Polyarteritis 1 (2%)
Spinal Cord (47) (48) (47) (47)
Thoracic, Infiltration Cellular, Lymphocytic 1 (2%)
Thoracic, Axon, Degeneration 12 (26%) 11 (23%) 9 (19%) 14 (30%)
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RESPIRATORY SYSTEM
a Number of animals examined microscopically at site and number of animals with lesion
Page 6
NTP Experiment-Test: 93029-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC LEUKOMALACHITE GREEN Date: 06/19/03
Route: DOSED FEED Time: 07:04:42
____________________________________________________________________________________________________________________________________
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%) 1 (2%)
Hemorrhage, Focal 1 (2%)
Infarct 1 (2%)
Infiltration Cellular, Histiocytic 1 (2%) 2 (4%) 2 (4%)
Infiltration Cellular, Lymphocytic 13 (28%) 7 (15%) 9 (19%) 12 (26%)
Inflammation, Chronic, Focal 1 (2%) 1 (2%) 1 (2%)
Inflammation, Granulomatous 1 (2%)
Leukocytosis 2 (4%) 1 (2%)
Alveolar Epithelium, Hyperplasia 1 (2%) 1 (2%) 1 (2%) 1 (2%)
Artery, Mineralization 1 (2%)
Vein, Thrombosis 1 (2%)
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SPECIAL SENSES SYSTEM
Eye (47) (48) (47) (47)
Phthisis Bulbi 1 (2%)
Bilateral, Lens, Cataract 4 (9%) 5 (10%) 3 (6%) 7 (15%)
Conjunctiva, Polyarteritis 1 (2%)
Cornea, Inflammation, Chronic 1 (2%)
Lens, Cataract 5 (11%) 4 (8%) 4 (9%) 4 (9%)
Harderian Gland (47) (48) (47) (47)
Atrophy 1 (2%)
Hyperplasia 1 (2%) 1 (2%) 3 (6%)
Infiltration Cellular, Lymphocytic 4 (9%) 9 (19%) 8 (17%) 5 (11%)
Acinus, Dilatation 1 (2%)
Zymbal's Gland (47) (47) (46) (47)
Atrophy 1 (2%) 1 (2%)
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URINARY SYSTEM
Kidney (47) (48) (47) (47)
Glomerulosclerosis 1 (2%) 1 (2%)
Hematopoietic Cell Proliferation 1 (2%)
Infarct 2 (4%) 1 (2%) 1 (2%)
Infiltration Cellular, Lymphocytic 9 (19%) 5 (10%) 15 (32%) 11 (23%)
Nephropathy 1 (2%) 2 (4%) 3 (6%) 1 (2%)
Polyarteritis 1 (2%)
Glomerulus, Casts Protein 1 (2%) 1 (2%)
Papilla, Casts Protein 1 (2%)
Pelvis, Dilatation 2 (4%) 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 7
NTP Experiment-Test: 93029-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC LEUKOMALACHITE GREEN Date: 06/19/03
Route: DOSED FEED Time: 07:04:42
____________________________________________________________________________________________________________________________________
C57BL/6N XC3H/HEN MTN-NCTR FEMALE 0 PPM 91 PPM 204 PPM 408 PPM
____________________________________________________________________________________________________________________________________
URINARY SYSTEM - CONT
Renal Tubule, Accumulation, Hyaline Droplet 1 (2%) 2 (4%) 1 (2%) 3 (6%)
Renal Tubule, Hyperplasia 1 (2%)
Renal Tubule, Hypertrophy 1 (2%)
Renal Tubule, Necrosis 1 (2%)
Renal Tubule, Pigmentation 1 (2%)
Urinary Bladder (46) (48) (47) (44)
Inclusion Body Intracytoplasmic 14 (30%) 33 (69%) 44 (94%) 44 (100%)
Infiltration Cellular, Lymphocytic 29 (63%) 22 (46%) 24 (51%) 26 (59%)
Polyarteritis 1 (2%)
Submucosa, Edema 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 8
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