TDMS Study 93005-03 Pathology Tables
NTP Experiment-Test: 93005-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC MALACHITE GREEN Date: 06/18/03
Route: DOSED FEED Time: 14:23:36
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
Page 1
NTP Experiment-Test: 93005-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC MALACHITE GREEN Date: 06/18/03
Route: DOSED FEED Time: 14:23:36
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 PPM 100 PPM 300 PPM 600 PPM
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DISPOSITION SUMMARY
Animals Initially In Study 48 48 48 48
Early Deaths
Natural Death 1 3 1 6
Moribund Sacrifice 18 22 15 17
Survivors
Terminal Sacrifice 29 23 32 25
Animals Examined Microscopically 48 48 48 48
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ALIMENTARY SYSTEM
Esophagus (48) (48) (48) (48)
Dilatation 1 (2%)
Foreign Body 1 (2%)
Intestine Small, Ileum (47) (46) (48) (47)
Dilatation 1 (2%)
Liver (48) (48) (48) (48)
Angiectasis 1 (2%)
Basophilic Focus 2 (4%) 3 (6%) 2 (4%) 7 (15%)
Basophilic Focus, Multiple 19 (40%) 14 (29%) 18 (38%) 8 (17%)
Clear Cell Focus 2 (4%)
Clear Cell Focus, Multiple 1 (2%)
Cyst 1 (2%)
Degeneration, Cystic 1 (2%)
Developmental Malformation 4 (8%) 7 (15%) 2 (4%) 5 (10%)
Eosinophilic Focus 3 (6%) 9 (19%) 3 (6%) 11 (23%)
Eosinophilic Focus, Multiple 2 (4%) 1 (2%) 10 (21%) 3 (6%)
Fatty Change 1 (2%)
Hematopoietic Cell Proliferation 2 (4%) 3 (6%) 4 (8%) 5 (10%)
Hepatodiaphragmatic Nodule 3 (6%) 6 (13%) 2 (4%) 3 (6%)
Infiltration Cellular, Lymphocyte 2 (4%) 3 (6%) 3 (6%) 8 (17%)
Inflammation, Focal, Granulomatous 18 (38%) 15 (31%) 23 (48%) 19 (40%)
Inflammation, Focal, Suppurative 1 (2%) 2 (4%)
Mixed Cell Focus 2 (4%)
Mixed Cell Focus, Multiple 1 (2%)
Necrosis 2 (4%) 2 (4%) 1 (2%)
Vacuolization Cytoplasmic 4 (8%) 4 (8%) 1 (2%) 6 (13%)
Bile Duct, Cyst 1 (2%)
Bile Duct, Hyperplasia 10 (21%) 10 (21%) 9 (19%) 5 (10%)
Centrilobular, Necrosis 4 (8%)
Mesentery (9) (5) (2) (4)
a Number of animals examined microscopically at site and number of animals with lesion
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NTP Experiment-Test: 93005-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC MALACHITE GREEN Date: 06/18/03
Route: DOSED FEED Time: 14:23:36
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 PPM 100 PPM 300 PPM 600 PPM
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Fat, Necrosis 7 (78%) 4 (80%) 2 (100%) 3 (75%)
Pancreas (48) (48) (48) (48)
Infiltration Cellular, Lymphocyte 1 (2%) 2 (4%)
Inflammation 1 (2%)
Acinus, Atrophy 13 (27%) 14 (29%) 12 (25%) 7 (15%)
Salivary Glands (48) (47) (48) (48)
Atrophy 2 (4%) 1 (2%) 1 (2%)
Infiltration Cellular, Lymphocyte 1 (2%) 1 (2%)
Stomach, Forestomach (48) (48) (48) (48)
Edema 1 (2%)
Erosion 1 (2%)
Inflammation 1 (2%) 2 (4%) 1 (2%)
Necrosis 1 (2%)
Epithelium, Hyperplasia 1 (2%) 1 (2%)
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CARDIOVASCULAR SYSTEM
Heart (48) (48) (48) (48)
Cardiomyopathy 13 (27%) 22 (46%) 19 (40%) 14 (29%)
Atrium, Thrombosis 1 (2%)
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ENDOCRINE SYSTEM
Adrenal Cortex (48) (48) (48) (48)
Accessory Adrenal Cortical Nodule 1 (2%) 1 (2%)
Angiectasis 10 (21%) 11 (23%) 17 (35%) 16 (33%)
Atrophy 2 (4%)
Hematopoietic Cell Proliferation 1 (2%)
Hyperplasia, Focal 1 (2%) 1 (2%) 1 (2%)
Hypertrophy, Focal 1 (2%) 4 (8%) 1 (2%) 4 (8%)
Infiltration Cellular, Lymphocyte 1 (2%)
Vacuolization Cytoplasmic 6 (13%) 5 (10%) 2 (4%) 3 (6%)
Adrenal Medulla (47) (47) (48) (48)
Hyperplasia 1 (2%) 3 (6%) 1 (2%) 1 (2%)
Islets, Pancreatic (48) (48) (48) (48)
Hyperplasia 1 (2%)
Parathyroid Gland (43) (43) (45) (39)
Hyperplasia, Focal 1 (2%)
Pituitary Gland (48) (47) (46) (45)
Angiectasis 5 (10%) 2 (4%) 2 (4%) 2 (4%)
Pars Distalis, Cyst 8 (17%) 5 (11%) 9 (20%) 9 (20%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 3
NTP Experiment-Test: 93005-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC MALACHITE GREEN Date: 06/18/03
Route: DOSED FEED Time: 14:23:36
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 PPM 100 PPM 300 PPM 600 PPM
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM - CONT
Pars Distalis, Hyperplasia 5 (10%) 11 (24%) 6 (13%)
Pars Intermedia, Cyst 1 (2%)
Thyroid Gland (46) (48) (47) (46)
C-Cell, Hyperplasia 8 (17%) 5 (10%) 11 (23%) 6 (13%)
Follicle, Cyst 1 (2%) 1 (2%) 3 (7%)
Follicular Cell, Hyperplasia 1 (2%) 2 (4%)
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GENERAL BODY SYSTEM
None
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GENITAL SYSTEM
Clitoral Gland (48) (48) (47) (47)
Hyperplasia 5 (10%) 4 (8%) 2 (4%) 6 (13%)
Inflammation 21 (44%) 30 (63%) 23 (49%) 26 (55%)
Metaplasia, Squamous 1 (2%)
Duct, Dilatation 6 (13%) 5 (10%) 7 (15%) 6 (13%)
Ovary (48) (48) (47) (48)
Atrophy 18 (38%) 14 (29%) 11 (23%) 10 (21%)
Congestion 1 (2%)
Cyst 5 (10%) 4 (8%) 7 (15%) 10 (21%)
Cyst, Multiple 1 (2%)
Infiltration Cellular, Lymphocyte 1 (2%)
Interstitial Cell, Hyperplasia 1 (2%)
Uterus (48) (48) (48) (48)
Decidual Reaction 1 (2%)
Hemorrhage 1 (2%)
Inflammation, Suppurative 1 (2%)
Thrombosis 1 (2%) 1 (2%)
Cervix, Hypertrophy 1 (2%) 1 (2%) 1 (2%)
Cervix, Serosa, Cyst 1 (2%)
Endometrium, Hyperplasia, Cystic 6 (13%) 3 (6%) 11 (23%) 8 (17%)
Vagina (48) (48) (48) (48)
Inflammation, Suppurative 3 (6%) 3 (6%) 5 (10%) 1 (2%)
Prolapse 2 (4%)
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HEMATOPOIETIC SYSTEM
Bone Marrow (48) (48) (48) (48)
a Number of animals examined microscopically at site and number of animals with lesion
Page 4
NTP Experiment-Test: 93005-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC MALACHITE GREEN Date: 06/18/03
Route: DOSED FEED Time: 14:23:36
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 PPM 100 PPM 300 PPM 600 PPM
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - CONT
Atrophy 1 (2%) 3 (6%) 2 (4%) 2 (4%)
Myelofibrosis 2 (4%)
Myelostromal Proliferation 1 (2%)
Myeloid Cell, Hyperplasia 5 (10%) 5 (10%) 4 (8%)
Lymph Node (10) (7) (7) (5)
Pigmentation 1 (14%)
Deep Cervical, Hemorrhage 1 (10%)
Deep Cervical, Hyperplasia, Lymphoid 1 (10%) 1 (20%)
Iliac, Hyperplasia, Lymphoid 1 (10%)
Lumbar, Ectasia 2 (40%)
Lumbar, Hematopoietic Cell Proliferation 1 (14%)
Lumbar, Hemorrhage 1 (14%) 1 (20%)
Lumbar, Hyperplasia, Lymphoid 2 (20%) 1 (20%)
Mediastinal, Hemorrhage 1 (10%) 1 (14%) 3 (43%)
Mediastinal, Hyperplasia, Lymphoid 2 (20%)
Pancreatic, Hematopoietic Cell Proliferation 1 (14%)
Pancreatic, Hemorrhage 1 (10%)
Pancreatic, Hyperplasia, Lymphoid 1 (10%) 1 (20%)
Renal, Ectasia 1 (10%)
Renal, Hemorrhage 2 (20%) 1 (14%)
Renal, Hyperplasia, Lymphoid 1 (14%) 1 (14%)
Lymph Node, Mandibular (47) (46) (47) (48)
Ectasia 1 (2%)
Hemorrhage 2 (4%)
Hyperplasia, Lymphoid 1 (2%) 3 (7%) 2 (4%) 5 (10%)
Infiltration Cellular, Plasma Cell 5 (11%) 5 (11%) 5 (11%) 7 (15%)
Lymph Node, Mesenteric (47) (47) (48) (48)
Ectasia 1 (2%)
Hemorrhage 1 (2%) 1 (2%)
Hyperplasia, Lymphoid 2 (4%)
Infiltration Cellular, Plasma Cell 1 (2%) 1 (2%)
Spleen (48) (48) (48) (48)
Atrophy 1 (2%)
Fibrosis 1 (2%)
Hematopoietic Cell Proliferation 6 (13%) 2 (4%) 7 (15%) 12 (25%)
Hyperplasia, Focal 1 (2%)
Pigmentation 1 (2%) 2 (4%) 2 (4%) 3 (6%)
Thrombosis 1 (2%)
Capsule, Hemorrhage 1 (2%)
Thymus (40) (42) (43) (40)
Cyst 1 (3%)
Ectopic Parathyroid Gland 1 (2%)
Hemorrhage 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 5
NTP Experiment-Test: 93005-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC MALACHITE GREEN Date: 06/18/03
Route: DOSED FEED Time: 14:23:36
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 PPM 100 PPM 300 PPM 600 PPM
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - CONT
Hyperplasia, Reticulum Cell 1 (3%)
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INTEGUMENTARY SYSTEM
Mammary Gland (46) (48) (48) (48)
Galactocele 4 (9%) 8 (17%) 2 (4%) 2 (4%)
Hyperplasia 28 (61%) 33 (69%) 29 (60%) 35 (73%)
Inflammation 1 (2%)
Duct, Dilatation 12 (26%) 22 (46%) 18 (38%) 11 (23%)
Skin (48) (48) (48) (48)
Hyperkeratosis 2 (4%)
Inflammation 1 (2%)
Epidermis, Hyperplasia 1 (2%)
Epidermis, Necrosis 2 (4%)
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MUSCULOSKELETAL SYSTEM
Bone (48) (48) (48) (48)
Femur, Fibrous Osteodystrophy 1 (2%) 1 (2%) 3 (6%)
Femur, Osteopetrosis 8 (17%) 3 (6%) 3 (6%) 3 (6%)
Sternum, Fibrous Osteodystrophy 1 (2%)
Sternum, Osteopetrosis 8 (17%) 3 (6%) 3 (6%) 3 (6%)
Turbinate, Osteopetrosis 7 (15%) 2 (4%) 2 (4%) 2 (4%)
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NERVOUS SYSTEM
Brain (48) (48) (48) (48)
Hemorrhage 1 (2%) 1 (2%)
Hypothalamus, Compression 5 (10%) 14 (29%) 10 (21%) 7 (15%)
Spinal Cord (48) (48) (48) (48)
Hemorrhage 1 (2%)
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RESPIRATORY SYSTEM
Lung (48) (48) (48) (48)
Foreign Body 1 (2%) 4 (8%)
Hemorrhage 2 (4%)
Inflammation, Chronic, Diffuse 1 (2%)
Inflammation, Chronic, Focal 1 (2%) 3 (6%) 4 (8%) 8 (17%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 6
NTP Experiment-Test: 93005-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC MALACHITE GREEN Date: 06/18/03
Route: DOSED FEED Time: 14:23:36
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 PPM 100 PPM 300 PPM 600 PPM
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM - CONT
Alveolar Epithelium, Hyperplasia, Focal 1 (2%) 1 (2%) 2 (4%)
Alveolus, Infiltration Cellular, Histiocyte 1 (2%) 1 (2%)
Nose (48) (48) (48) (48)
Foreign Body 1 (2%) 2 (4%)
Inflammation, Chronic 1 (2%)
Inflammation, Suppurative 1 (2%) 2 (4%)
Nasolacrimal Duct, Inflammation 19 (40%) 10 (21%) 11 (23%) 13 (27%)
Olfactory Epithelium, Cytoplasmic Alteration 2 (4%) 3 (6%) 6 (13%) 1 (2%)
Olfactory Epithelium, Respiratory Epithelium,
Cytoplasmic Alteration 1 (2%) 2 (4%)
Respiratory Epithelium, Cytoplasmic
Alteration 1 (2%)
Trachea (48) (48) (48) (48)
Inflammation 3 (6%) 1 (2%)
Epithelium, Hyperplasia 1 (2%) 2 (4%)
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SPECIAL SENSES SYSTEM
Eye (47) (48) (48) (48)
Cataract 7 (15%) 2 (4%) 7 (15%)
Hemorrhage 1 (2%)
Phthisis Bulbi 2 (4%)
Bilateral, Cataract 1 (2%) 1 (2%) 2 (4%) 2 (4%)
Bilateral, Retina, Degeneration 13 (28%) 14 (29%) 20 (42%) 18 (38%)
Cornea, Inflammation 1 (2%)
Retina, Autolysis 1 (2%) 4 (8%) 2 (4%)
Retina, Degeneration 8 (17%) 8 (17%) 9 (19%) 9 (19%)
Sclera, Metaplasia, Osseous 1 (2%)
Harderian Gland (47) (48) (48) (48)
Atrophy 1 (2%)
Infiltration Cellular, Lymphocyte 34 (72%) 37 (77%) 36 (75%) 32 (67%)
Inflammation 1 (2%)
Pigmentation 1 (2%)
Lacrimal Gland (18) (14) (15) (9)
Infiltration Cellular, Lymphocyte 2 (11%) 2 (14%) 2 (13%) 3 (33%)
Metaplasia 18 (100%) 14 (100%) 15 (100%) 9 (100%)
Zymbal's Gland (47) (48) (48) (46)
Hyperplasia 1 (2%) 1 (2%)
Metaplasia, Squamous 1 (2%)
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a Number of animals examined microscopically at site and number of animals with lesion
Page 7
NTP Experiment-Test: 93005-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC MALACHITE GREEN Date: 06/18/03
Route: DOSED FEED Time: 14:23:36
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 PPM 100 PPM 300 PPM 600 PPM
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (48) (48) (48) (48)
Hydronephrosis 1 (2%)
Mineralization 33 (69%) 31 (65%) 30 (63%) 30 (63%)
Nephropathy 39 (81%) 38 (79%) 41 (85%) 40 (83%)
Pelvis, Inflammation 1 (2%)
Pelvis, Transitional Epithelium, Hyperplasia 1 (2%)
Renal Tubule, Necrosis 1 (2%)
Urinary Bladder (47) (48) (47) (47)
Infiltration Cellular, Lymphocyte 1 (2%) 1 (2%) 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
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