TDMS Study 93005-03 Pathology Tables
NTP Experiment-Test: 93005-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 06/18/03
Route: DOSED FEED MALACHITE GREEN Time: 14:30:44
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: 93005-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 06/18/03
Route: DOSED FEED MALACHITE GREEN Time: 14:30:44
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 PPM 100 PPM 300 PPM 600 PPM
____________________________________________________________________________________________________________________________________
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 [3.0]
Foreign Body 1
Intestine Small, Ileum (47) (46) (48) (47)
Dilatation 1 [3.0]
Liver (48) (48) (48) (48)
Angiectasis 1 [2.0]
Basophilic Focus 2 3 2 7
Basophilic Focus, Multiple 19 14 18 8
Clear Cell Focus 2
Clear Cell Focus, Multiple 1
Cyst 1 [2.0]
Degeneration, Cystic 1 [2.0]
Developmental Malformation 4 [0.0] 7 [0.0] 2 [0.0] 5 [1.0]
Eosinophilic Focus 3 9 3 11
Eosinophilic Focus, Multiple 2 1 10 3
Fatty Change 1 [2.0]
Hematopoietic Cell Proliferation 2 [1.5] 3 [1.0] 4 [1.0] 5 [1.8]
Hepatodiaphragmatic Nodule 3 6 2 3
Infiltration Cellular, Lymphocyte 2 [1.0] 3 [1.3] 3 [1.0] 8 [1.0]
Inflammation, Focal, Granulomatous 18 [1.6] 15 [1.5] 23 [1.5] 19 [1.3]
Inflammation, Focal, Suppurative 1 [1.0] 2 [2.5]
Mixed Cell Focus 2
Mixed Cell Focus, Multiple 1
Necrosis 2 [1.5] 2 [1.5] 1 [1.0]
Vacuolization Cytoplasmic 4 [2.3] 4 [2.8] 1 [3.0] 6 [1.8]
Bile Duct, Cyst 1 [2.0]
Bile Duct, Hyperplasia 10 [1.4] 10 [1.7] 9 [1.4] 5 [1.2]
Centrilobular, Necrosis 4 [2.5]
Mesentery (9) (5) (2) (4)
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: 93005-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 06/18/03
Route: DOSED FEED MALACHITE GREEN Time: 14:30:44
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 PPM 100 PPM 300 PPM 600 PPM
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Fat, Necrosis 7 [2.6] 4 [3.0] 2 [2.5] 3 [2.7]
Pancreas (48) (48) (48) (48)
Infiltration Cellular, Lymphocyte 1 [1.0] 2 [1.0]
Inflammation 1 [2.0]
Acinus, Atrophy 13 [1.2] 14 [1.6] 12 [1.3] 7 [1.1]
Salivary Glands (48) (47) (48) (48)
Atrophy 2 [1.5] 1 [1.0] 1 [2.0]
Infiltration Cellular, Lymphocyte 1 [1.0] 1 [1.0]
Stomach, Forestomach (48) (48) (48) (48)
Edema 1 [2.0]
Erosion 1 [2.0]
Inflammation 1 [3.0] 2 [2.0] 1 [3.0]
Necrosis 1 [2.0]
Epithelium, Hyperplasia 1 [2.0] 1 [1.0]
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CARDIOVASCULAR SYSTEM
Heart (48) (48) (48) (48)
Cardiomyopathy 13 [1.5] 22 [1.1] 19 [1.1] 14 [1.2]
Atrium, Thrombosis 1 [2.0]
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ENDOCRINE SYSTEM
Adrenal Cortex (48) (48) (48) (48)
Accessory Adrenal Cortical Nodule 1 [2.0] 1 [2.0]
Angiectasis 10 [1.3] 11 [1.5] 17 [1.5] 16 [1.6]
Atrophy 2 [2.0]
Hematopoietic Cell Proliferation 1 [1.0]
Hyperplasia, Focal 1 [2.0] 1 [2.0] 1 [2.0]
Hypertrophy, Focal 1 [2.0] 4 [1.5] 1 [2.0] 4 [1.8]
Infiltration Cellular, Lymphocyte 1 [1.0]
Vacuolization Cytoplasmic 6 [1.3] 5 [1.8] 2 [1.5] 3 [1.3]
Adrenal Medulla (47) (47) (48) (48)
Hyperplasia 1 [1.0] 3 [2.3] 1 [3.0] 1 [1.0]
Islets, Pancreatic (48) (48) (48) (48)
Hyperplasia 1 [2.0]
Parathyroid Gland (43) (43) (45) (39)
Hyperplasia, Focal 1 [2.0]
Pituitary Gland (48) (47) (46) (45)
Angiectasis 5 [2.4] 2 [1.5] 2 [2.0] 2 [2.0]
Pars Distalis, Cyst 8 [1.5] 5 [1.4] 9 [1.9] 9 [1.9]
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: 93005-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 06/18/03
Route: DOSED FEED MALACHITE GREEN Time: 14:30:44
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 PPM 100 PPM 300 PPM 600 PPM
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM - CONT
Pars Distalis, Hyperplasia 5 [2.0] 11 [2.2] 6 [1.8]
Pars Intermedia, Cyst 1 [2.0]
Thyroid Gland (46) (48) (47) (46)
C-Cell, Hyperplasia 8 [1.4] 5 [1.4] 11 [1.4] 6 [1.7]
Follicle, Cyst 1 [3.0] 1 [3.0] 3 [2.0]
Follicular Cell, Hyperplasia 1 [1.0] 2 [1.0]
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GENERAL BODY SYSTEM
None
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GENITAL SYSTEM
Clitoral Gland (48) (48) (47) (47)
Hyperplasia 5 [2.2] 4 [2.0] 2 [2.0] 6 [2.2]
Inflammation 21 [2.1] 30 [2.2] 23 [2.2] 26 [2.2]
Metaplasia, Squamous 1 [2.0]
Duct, Dilatation 6 [2.8] 5 [2.8] 7 [2.6] 6 [2.7]
Ovary (48) (48) (47) (48)
Atrophy 18 [2.4] 14 [2.1] 11 [2.5] 10 [2.0]
Congestion 1 [3.0]
Cyst 5 [2.4] 4 [2.3] 7 [2.0] 10 [2.1]
Cyst, Multiple 1 [2.0]
Infiltration Cellular, Lymphocyte 1 [3.0]
Interstitial Cell, Hyperplasia 1 [3.0]
Uterus (48) (48) (48) (48)
Decidual Reaction 1 [2.0]
Hemorrhage 1 [4.0]
Inflammation, Suppurative 1 [2.0]
Thrombosis 1 [3.0] 1 [3.0]
Cervix, Hypertrophy 1 [3.0] 1 [3.0] 1 [2.0]
Cervix, Serosa, Cyst 1 [3.0]
Endometrium, Hyperplasia, Cystic 6 [2.0] 3 [1.7] 11 [1.8] 8 [1.8]
Vagina (48) (48) (48) (48)
Inflammation, Suppurative 3 [2.0] 3 [2.3] 5 [2.0] 1 [2.0]
Prolapse 2 [3.0]
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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
b Average severity grade (1-minimal;2-mild;3-moderate;4-marked)
Page 4
NTP Experiment-Test: 93005-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 06/18/03
Route: DOSED FEED MALACHITE GREEN Time: 14:30:44
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 PPM 100 PPM 300 PPM 600 PPM
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - CONT
Atrophy 1 [2.0] 3 [1.7] 2 [2.0] 2 [2.0]
Myelofibrosis 2 [2.0]
Myelostromal Proliferation 1 [2.0]
Myeloid Cell, Hyperplasia 5 [2.0] 5 [2.0] 4 [2.3]
Lymph Node (10) (7) (7) (5)
Pigmentation 1 [2.0]
Deep Cervical, Hemorrhage 1 [2.0]
Deep Cervical, Hyperplasia, Lymphoid 1 [2.0] 1 [2.0]
Iliac, Hyperplasia, Lymphoid 1 [2.0]
Lumbar, Ectasia 2 [3.0]
Lumbar, Hematopoietic Cell Proliferation 1 [2.0]
Lumbar, Hemorrhage 1 [2.0] 1 [1.0]
Lumbar, Hyperplasia, Lymphoid 2 [2.0] 1 [4.0]
Mediastinal, Hemorrhage 1 [2.0] 1 [2.0] 3 [2.3]
Mediastinal, Hyperplasia, Lymphoid 2 [2.0]
Pancreatic, Hematopoietic Cell Proliferation 1 [3.0]
Pancreatic, Hemorrhage 1 [2.0]
Pancreatic, Hyperplasia, Lymphoid 1 [2.0] 1 [2.0]
Renal, Ectasia 1 [3.0]
Renal, Hemorrhage 2 [2.0] 1 [1.0]
Renal, Hyperplasia, Lymphoid 1 [2.0] 1 [2.0]
Lymph Node, Mandibular (47) (46) (47) (48)
Ectasia 1 [2.0]
Hemorrhage 2 [2.5]
Hyperplasia, Lymphoid 1 [2.0] 3 [2.0] 2 [2.0] 5 [2.6]
Infiltration Cellular, Plasma Cell 5 [2.2] 5 [2.0] 5 [2.2] 7 [2.0]
Lymph Node, Mesenteric (47) (47) (48) (48)
Ectasia 1 [2.0]
Hemorrhage 1 [2.0] 1 [2.0]
Hyperplasia, Lymphoid 2 [2.0]
Infiltration Cellular, Plasma Cell 1 [3.0] 1 [2.0]
Spleen (48) (48) (48) (48)
Atrophy 1 [3.0]
Fibrosis 1 [3.0]
Hematopoietic Cell Proliferation 6 [2.8] 2 [2.0] 7 [2.3] 12 [2.2]
Hyperplasia, Focal 1 [4.0]
Pigmentation 1 [3.0] 2 [3.0] 2 [3.0] 3 [3.0]
Thrombosis 1 [3.0]
Capsule, Hemorrhage 1 [3.0]
Thymus (40) (42) (43) (40)
Cyst 1 [2.0]
Ectopic Parathyroid Gland 1 [2.0]
Hemorrhage 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: 93005-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 06/18/03
Route: DOSED FEED MALACHITE GREEN Time: 14:30:44
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 PPM 100 PPM 300 PPM 600 PPM
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - CONT
Hyperplasia, Reticulum Cell 1 [3.0]
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INTEGUMENTARY SYSTEM
Mammary Gland (46) (48) (48) (48)
Galactocele 4 [2.5] 8 [3.0] 2 [2.5] 2 [2.5]
Hyperplasia 28 [2.1] 33 [1.8] 29 [1.9] 35 [2.0]
Inflammation 1 [3.0]
Duct, Dilatation 12 [2.0] 22 [1.9] 18 [1.9] 11 [2.1]
Skin (48) (48) (48) (48)
Hyperkeratosis 2 [2.5]
Inflammation 1 [3.0]
Epidermis, Hyperplasia 1 [2.0]
Epidermis, Necrosis 2 [2.0]
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MUSCULOSKELETAL SYSTEM
Bone (48) (48) (48) (48)
Femur, Fibrous Osteodystrophy 1 [3.0] 1 [2.0] 3 [1.0]
Femur, Osteopetrosis 8 [2.6] 3 [2.0] 3 [2.7] 3 [2.3]
Sternum, Fibrous Osteodystrophy 1 [2.0]
Sternum, Osteopetrosis 8 [2.6] 3 [2.0] 3 [2.7] 3 [2.3]
Turbinate, Osteopetrosis 7 [2.7] 2 [2.5] 2 [3.0] 2 [2.5]
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NERVOUS SYSTEM
Brain (48) (48) (48) (48)
Hemorrhage 1 [1.0] 1 [2.0]
Hypothalamus, Compression 5 [1.8] 14 [2.0] 10 [2.3] 7 [2.3]
Spinal Cord (48) (48) (48) (48)
Hemorrhage 1 [1.0]
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RESPIRATORY SYSTEM
Lung (48) (48) (48) (48)
Foreign Body 1 [2.0] 4 [2.8]
Hemorrhage 2 [1.5]
Inflammation, Chronic, Diffuse 1 [2.0]
Inflammation, Chronic, Focal 1 [2.0] 3 [1.7] 4 [1.8] 8 [1.9]
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: 93005-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 06/18/03
Route: DOSED FEED MALACHITE GREEN Time: 14:30:44
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 PPM 100 PPM 300 PPM 600 PPM
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM - CONT
Alveolar Epithelium, Hyperplasia, Focal 1 [2.0] 1 [2.0] 2 [3.0]
Alveolus, Infiltration Cellular, Histiocyte 1 [1.0] 1 [2.0]
Nose (48) (48) (48) (48)
Foreign Body 1 [2.0] 2 [3.0]
Inflammation, Chronic 1 [2.0]
Inflammation, Suppurative 1 [3.0] 2 [3.0]
Nasolacrimal Duct, Inflammation 19 [1.7] 10 [1.6] 11 [1.7] 13 [1.7]
Olfactory Epithelium, Cytoplasmic Alteration 2 [2.5] 3 [2.3] 6 [1.8] 1 [1.0]
Olfactory Epithelium, Respiratory Epithelium,
Cytoplasmic Alteration 1 [2.0] 2 [3.0]
Respiratory Epithelium, Cytoplasmic
Alteration 1 [1.0]
Trachea (48) (48) (48) (48)
Inflammation 3 [1.7] 1 [3.0]
Epithelium, Hyperplasia 1 [2.0] 2 [2.5]
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SPECIAL SENSES SYSTEM
Eye (47) (48) (48) (48)
Cataract 7 [1.4] 2 [1.5] 7 [1.9]
Hemorrhage 1 [2.0]
Phthisis Bulbi 2
Bilateral, Cataract 1 [1.0] 1 [2.0] 2 [2.0] 2 [2.0]
Bilateral, Retina, Degeneration 13 [2.8] 14 [2.1] 20 [2.2] 18 [2.3]
Cornea, Inflammation 1 [3.0]
Retina, Autolysis 1 4 2
Retina, Degeneration 8 [2.1] 8 [2.0] 9 [1.9] 9 [2.1]
Sclera, Metaplasia, Osseous 1 [2.0]
Harderian Gland (47) (48) (48) (48)
Atrophy 1 [1.0]
Infiltration Cellular, Lymphocyte 34 [1.4] 37 [1.2] 36 [1.3] 32 [1.4]
Inflammation 1 [3.0]
Pigmentation 1 [3.0]
Lacrimal Gland (18) (14) (15) (9)
Infiltration Cellular, Lymphocyte 2 [1.5] 2 [1.0] 2 [1.5] 3 [1.0]
Metaplasia 18 [2.0] 14 [1.9] 15 [2.0] 9 [2.1]
Zymbal's Gland (47) (48) (48) (46)
Hyperplasia 1 [2.0] 1 [2.0]
Metaplasia, Squamous 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 7
NTP Experiment-Test: 93005-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 06/18/03
Route: DOSED FEED MALACHITE GREEN Time: 14:30:44
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 PPM 100 PPM 300 PPM 600 PPM
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (48) (48) (48) (48)
Hydronephrosis 1 [2.0]
Mineralization 33 [2.0] 31 [2.0] 30 [1.9] 30 [1.8]
Nephropathy 39 [1.4] 38 [1.6] 41 [1.4] 40 [1.5]
Pelvis, Inflammation 1 [1.0]
Pelvis, Transitional Epithelium, Hyperplasia 1 [1.0]
Renal Tubule, Necrosis 1 [3.0]
Urinary Bladder (47) (48) (47) (47)
Infiltration Cellular, Lymphocyte 1 [1.0] 1 [1.0] 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 8
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