TDMS Study 93029-03 Pathology Tables
NTP Experiment-Test: 93029-03 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 LEUKOMALACHITE GREEN Time: 15:15:27
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: 93029-03 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 LEUKOMALACHITE GREEN Time: 15:15:27
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS-NCTR FEMALE 0 PPM 91 PPM 272 PPM 543 PPM
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 48 48 48 48
Early Deaths
Moribund 12 11 12 10
Natural Death 3 1 1 4
Survivors
Moribund 1
Terminal Sacrifice 33 36 35 33
Animals Examined Microscopically 48 48 48 48
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Intestine Large (48) (48) (48) (48)
Cecum, Inflammation 1 [4.0]
Cecum, Lymphoid Tissue, Hyperplasia 1 [2.0]
Colon, Lymphoid Tissue, Hyperplasia 1 [2.0] 1 [2.0] 1 [2.0]
Rectum, Inflammation 1 [2.0]
Intestine Small (48) (48) (48) (48)
Ileum, Dilatation 1 [2.0]
Ileum, Inflammation 1 [4.0]
Ileum, Lymphoid Tissue, Hyperplasia 1 [2.0] 2 [2.0] 1 [3.0]
Liver (48) (48) (48) (48)
Angiectasis 1 [2.0]
Basophilic Focus 3 4 2 1
Basophilic Focus, Multiple 20 26 2
Degeneration, Cystic 3 [2.0] 2 [1.0] 5 [1.6] 3 [2.0]
Developmental Malformation 7 5 3 5
Eosinophilic Focus 3 4 13 5
Eosinophilic Focus, Multiple 8 7 11
Hematopoietic Cell Proliferation 1 [1.0] 1 [1.0] 3 [1.0] 1 [1.0]
Hepatodiaphragmatic Nodule 4 1 5 1
Infiltration Cellular, Lymphocyte 2 [1.5] 3 [1.0] 7 [1.1] 4 [1.0]
Inflammation, Focal, Granulomatous 10 [1.9] 19 [1.7] 20 [1.7] 13 [1.2]
Mixed Cell Focus 1
Necrosis 4 [1.8] 2 [1.5] 1 [2.0] 3 [1.3]
Tension Lipidosis 1 [3.0] 2 [2.5]
Tension Lipidosis, Multiple 1 [2.0]
Vacuolization Cytoplasmic 5 [2.0] 5 [1.4] 17 [1.8] 22 [1.7]
Bile Duct, Cyst 2
Bile Duct, Hyperplasia 16 [1.5] 18 [1.2] 19 [1.5] 18 [1.3]
Centrilobular, Necrosis 1 [3.0] 2 [2.5]
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: 93029-03 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 LEUKOMALACHITE GREEN Time: 15:15:27
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS-NCTR FEMALE 0 PPM 91 PPM 272 PPM 543 PPM
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Mesentery (8) (7) (1) (4)
Accessory Spleen 2 1
Fat, Necrosis 6 [2.3] 5 [2.4] 1 [3.0] 3 [2.7]
Pancreas (48) (48) (47) (48)
Infiltration Cellular, Lymphocyte 2 [1.0] 3 [1.0] 1 [1.0]
Inflammation 1 [2.0] 1 [1.0]
Acinus, Atrophy 20 [2.1] 16 [1.3] 17 [1.9] 18 [1.9]
Salivary Glands (48) (48) (48) (48)
Atrophy 2 [2.0] 1 [2.0]
Infiltration Cellular, Lymphocyte 1 [1.0]
Parotid Gland, Hypertrophy, Focal 1 [2.0]
Stomach (48) (48) (48) (48)
Forestomach, Edema 1 [2.0]
Forestomach, Inflammation 2 [3.0] 1 [2.0] 1 [2.0]
Forestomach, Epithelium, Hyperplasia 2 [3.0] 1 [2.0]
Glandular, Edema 1 [3.0]
Tongue (48) (48) (48) (48)
Epithelium, Hyperplasia, Focal 1 [1.0]
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (48) (48) (48) (48)
Cardiomyopathy 35 [1.6] 35 [1.7] 33 [1.5] 30 [1.5]
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Gland (47) (48) (47) (48)
Cortex, Accessory Adrenal Cortical Nodule 3
Cortex, Angiectasis 8 [1.6] 10 [1.9] 2 [2.0] 3 [1.3]
Cortex, Atrophy 1 [2.0]
Cortex, Degeneration 1 [3.0]
Cortex, Hyperplasia, Focal 4 [1.3] 2 [2.0] 4 [1.5] 5 [1.0]
Cortex, Hypertrophy, Focal 2 [1.5] 2 [1.5]
Cortex, Thrombosis 1 [3.0]
Cortex, Vacuolization Cytoplasmic 2 [2.5] 1 [2.0]
Medulla, Hyperplasia 1 [2.0]
Pituitary Gland (47) (47) (45) (46)
Angiectasis 3 [1.3] 1 [3.0] 1 [4.0] 2 [2.0]
Pars Distalis, Cyst 8 4 6 1
Pars Distalis, Hyperplasia 2 [2.0] 4 [2.3] 4 [2.0] 5 [2.0]
Thyroid Gland (46) (46) (47) (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 3
NTP Experiment-Test: 93029-03 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 LEUKOMALACHITE GREEN Time: 15:15:27
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS-NCTR FEMALE 0 PPM 91 PPM 272 PPM 543 PPM
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM - CONT
C-Cell, Hyperplasia 13 [1.4] 5 [1.0] 6 [1.8] 1 [2.0]
Follicle, Cyst 1 [2.0] 2 [1.0]
Follicular Cell, Hyperplasia 1 [2.0] 3 [1.3]
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Clitoral Gland (47) (47) (46) (47)
Hyperplasia 4 [2.8] 4 [2.0] 5 [2.6] 3 [1.7]
Inflammation 23 [1.9] 31 [1.9] 22 [1.9] 28 [2.1]
Duct, Dilatation 25 [2.4] 24 [2.4] 18 [2.3] 15 [2.1]
Duct, Hyperplasia 1 [2.0]
Ovary (48) (48) (48) (48)
Atrophy 6 [2.0] 5 [2.4] 10 [2.3] 7 [2.1]
Cyst 8 5 10 4
Infiltration Cellular, Lymphocyte 3 [2.7] 3 [2.7] 3 [2.3]
Periovarian Tissue, Hemorrhage 1 [2.0]
Uterus (48) (48) (48) (48)
Decidual Reaction 1 1
Hemorrhage 1 [3.0] 1 [3.0]
Inflammation 1 [1.0]
Thrombosis 1
Bilateral, Horn, Dilatation 1 [3.0]
Cervix, Hypertrophy 5 5 2 5
Endometrium, Hyperplasia 1 [3.0]
Endometrium, Hyperplasia, Cystic 3 [1.7] 3 [2.3] 4 [2.0] 7 [2.1]
Vagina (48) (48) (48) (48)
Cyst 1
Exudate, Mucous 1 [3.0] 1 [2.0]
Hemorrhage 1 [3.0]
Inflammation, Suppurative 3 [3.0] 2 [2.0] 1 [3.0] 2 [2.0]
Metaplasia, Squamous 1 [2.0]
Prolapse 1
____________________________________________________________________________________________________________________________________
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: 93029-03 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 LEUKOMALACHITE GREEN Time: 15:15:27
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS-NCTR FEMALE 0 PPM 91 PPM 272 PPM 543 PPM
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - CONT
Atrophy 4 [2.0] 2 [1.0] 4 [2.0] 3 [2.0]
Myelostromal Proliferation 1 [4.0]
Myeloid Cell, Hyperplasia 1 [2.0]
Lymph Node (48) (48) (48) (48)
Hyperplasia, Lymphoid 1 [3.0]
Bronchial, Hyperplasia, Lymphoid 1 [2.0]
Lumbar, Ectasia 1 [3.0]
Lumbar, Hyperplasia, Lymphoid 1 [2.0]
Mandibular, Ectasia 2 [2.0] 2 [2.0]
Mandibular, Hyperplasia, Lymphoid 1 [2.0] 1 [2.0] 4 [2.3] 1 [2.0]
Mandibular, Infiltration Cellular, Plasma
Cell 4 [2.0] 8 [2.3] 4 [2.0]
Mediastinal, Ectasia 1 [2.0] 1 [2.0]
Mediastinal, Hemorrhage 1 [2.0] 3 [2.0] 1 [3.0]
Mediastinal, Hyperplasia, Lymphoid 1 [2.0] 1 [2.0] 1 [3.0]
Mediastinal, Infiltration Cellular, Plasma
Cell 1 [2.0]
Mesenteric, Angiectasis 1 [2.0]
Mesenteric, Ectasia 2 [2.0] 1 [3.0] 4 [2.5] 2 [2.5]
Mesenteric, Hemorrhage 1 [2.0] 2 [2.0]
Mesenteric, Hyperplasia, Lymphoid 1 [2.0] 2 [2.0] 2 [2.0]
Pancreatic, Ectasia 1 [3.0]
Pancreatic, Hemorrhage 1 [2.0] 1 [2.0]
Pancreatic, Hyperplasia, Lymphoid 1 [2.0] 2 [2.0] 1 [3.0]
Renal, Ectasia 1 [2.0]
Renal, Hemorrhage 1 [2.0]
Renal, Hyperplasia, Lymphoid 2 [2.0] 1 [2.0]
Spleen (48) (48) (48) (48)
Angiectasis 1 [2.0]
Fibrosis 1 [1.0]
Hematopoietic Cell Proliferation 3 [3.0] 4 [2.0] 6 [2.5] 5 [2.4]
Hyperplasia, Focal 1 [4.0]
Pigmentation 1 [3.0] 2 [2.5] 3 [2.7] 1 [2.0]
Stromal Hyperplasia 1 [2.0]
Thymus (41) (47) (44) (42)
Cyst 2 1 1
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (48) (46) (48) (48)
Galactocele 7 2
Hyperplasia 25 [2.0] 20 [2.0] 19 [1.8] 22 [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: 93029-03 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 LEUKOMALACHITE GREEN Time: 15:15:27
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS-NCTR FEMALE 0 PPM 91 PPM 272 PPM 543 PPM
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM - CONT
Infiltration Cellular, Lymphocyte 1 [2.0]
Duct, Dilatation 10 [2.0] 13 [2.2] 7 [1.9] 3 [2.0]
Skin (48) (48) (48) (48)
Abscess 1 [3.0]
Hyperkeratosis, Multifocal 1 [2.0]
Inflammation 2 [2.5] 1 [2.0] 1 [2.0]
Epidermis, Hyperplasia 3 [2.3] 1 [2.0] 3 [2.0] 3 [2.0]
Epidermis, Necrosis 1 [1.0] 1 [2.0] 2 [1.5] 3 [2.0]
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (48) (48) (48) (48)
Cranium, Osteopetrosis 1 [3.0]
Femur, Fibrous Osteodystrophy 2 [2.5]
Femur, Fracture Healed 1
Femur, Osteopetrosis 1 [3.0] 4 [3.3] 3 [2.7] 1 [3.0]
Mandible, Osteopetrosis 1 [3.0]
Maxilla, Inflammation, Chronic 1 [3.0]
Sternum, Fibrous Osteodystrophy 1 [3.0] 1 [1.0]
Sternum, Osteopetrosis 1 [3.0] 4 [3.3] 4 [2.5] 1 [3.0]
Turbinate, Osteopetrosis 1 [2.0] 3 [3.0] 4 [2.3] 1 [3.0]
Skeletal Muscle (48) (48) (48) (48)
Mineralization, Multifocal 1 [2.0]
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (48) (48) (48) (48)
Brain Stem, Hemorrhage 1 [2.0]
Brain Stem, Hypothalamus, Compression 11 [2.2] 6 [2.0] 5 [2.2] 5 [2.0]
Cerebrum, Hemorrhage 1 [1.0] 1 [1.0]
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (48) (48) (48) (48)
Infiltration Cellular, Lymphocyte 1 [1.0]
Alveolar Epithelium, Hyperplasia 3 [1.3] 1 [1.0] 2 [2.0]
Alveolar Epithelium, Metaplasia, Focal,
Squamous 1 [1.0]
Alveolus, Infiltration Cellular, Multifocal 1 [1.0]
Alveolus, Infiltration Cellular, Histiocyte 4 [1.0] 3 [1.0] 10 [1.0] 6 [1.5]
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: 93029-03 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 LEUKOMALACHITE GREEN Time: 15:15:27
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS-NCTR FEMALE 0 PPM 91 PPM 272 PPM 543 PPM
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM - CONT
Alveolus, Inflammation, Multifocal 1 [2.0] 1 [1.0]
Nose (48) (48) (48) (48)
Inflammation, Suppurative 1 [2.0]
Nasolacrimal Duct, Cyst Epithelial Inclusion 1
Nasolacrimal Duct, Inflammation 21 [1.8] 19 [1.7] 18 [1.6] 19 [1.5]
Respiratory Epithelium, Concretion 1 [1.0]
Trachea (48) (48) (48) (48)
Inflammation, Chronic 1 [2.0]
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (48) (48) (48) (48)
Cataract 2 [2.0] 5 [1.6]
Phthisis Bulbi 1 1 2
Bilateral, Cataract 1 [2.0] 1 [2.0] 2 [1.0]
Bilateral, Retina, Degeneration 4 [2.0] 4 [2.0] 5 [1.8] 7 [2.1]
Conjunctiva, Inflammation 1 [2.0]
Cornea, Neovascularization 1 [2.0]
Retina, Autolysis 5 1 1 3
Retina, Degeneration 3 [1.3] 6 [1.7] 9 [2.1]
Sclera, Metaplasia, Osseous 1 [1.0]
Harderian Gland (48) (48) (48) (48)
Hyperplasia 1 [3.0]
Infiltration Cellular, Focal, Histiocyte 1 [1.0]
Infiltration Cellular, Lymphocyte 19 [1.3] 26 [1.3] 22 [1.4] 21 [1.2]
Inflammation 1 [1.0]
Lacrimal Gland (10) (6) (8) (4)
Infiltration Cellular, Lymphocyte 3 [1.7] 1 [1.0] 2 [2.0]
Metaplasia 10 [2.0] 6 [1.8] 8 [2.1] 4 [2.0]
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (48) (48) (48) (48)
Hydronephrosis 1 [1.0] 1 [2.0]
Infarct 1 [2.0]
Infiltration Cellular, Lymphocyte 1 [1.0]
Mineralization 47 [1.9] 46 [1.9] 47 [1.9] 48 [1.9]
Necrosis, Focal 1 [1.0]
Nephropathy 34 [1.2] 31 [1.2] 27 [1.2] 29 [1.2]
Pigmentation 2 [2.0] 2 [2.0]
Urinary Bladder (47) (47) (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 7
NTP Experiment-Test: 93029-03 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 LEUKOMALACHITE GREEN Time: 15:15:27
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS-NCTR FEMALE 0 PPM 91 PPM 272 PPM 543 PPM
____________________________________________________________________________________________________________________________________
URINARY SYSTEM - CONT
Hemorrhage 1 [3.0]
Infiltration Cellular, Lymphocyte 1 [1.0] 1 [1.0] 2 [1.0]
Inflammation 2 [1.5]
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
NTP Experiment-Test: 93029-03 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 LEUKOMALACHITE GREEN Time: 15:15:27
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS-NCTR MALE 0 PPM 91 PPM 272 PPM 543 PPM
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 48 48 48 48
Early Deaths
Moribund 20 12 11 10
Natural Death 4 5 3 7
Survivors
Natural Death 1 1
Terminal Sacrifice 23 29 34 30
Wrong Sex 1 1
Animals Examined Microscopically 48 47 48 47
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Intestine Large (48) (47) (48) (47)
Artery, Colon, Serosa, Dilatation 1
Cecum, Lymphoid Tissue, Hyperplasia 3 [2.3] 1 [2.0]
Colon, Lymphoid Tissue, Hyperplasia 2 [2.5] 1 [3.0]
Intestine Small (47) (47) (48) (47)
Duodenum, Autolysis 1 [3.0]
Ileum, Hyperplasia 1 [3.0]
Ileum, Inflammation 1 [2.0]
Ileum, Lymphoid Tissue, Hyperplasia 4 [2.0] 1 [2.0] 1 [2.0] 3 [2.3]
Jejunum, Autolysis 1 [3.0]
Jejunum, Diverticulum 1
Jejunum, Lymphoid Tissue, Hyperplasia 1 [2.0] 2 [2.0]
Liver (48) (47) (48) (47)
Basophilic Focus 2 2
Degeneration, Cystic 4 [2.0] 18 [1.3] 13 [1.5] 19 [1.4]
Developmental Malformation 1 1 1
Eosinophilic Focus 2 8 9 8
Eosinophilic Focus, Multiple 1 6 10 25
Hematopoietic Cell Proliferation 1 [1.0]
Hepatodiaphragmatic Nodule 2 2 3
Infiltration Cellular, Lymphocyte 1 [1.0]
Inflammation, Focal, Granulomatous 3 [2.0] 1 [1.0] 1 [2.0] 1 [2.0]
Mixed Cell Focus 1 2
Necrosis 1 [2.0] 1 [2.0]
Pigmentation 1 [1.0]
Vacuolization Cytoplasmic 9 [2.0] 21 [1.9] 10 [1.9] 13 [1.8]
Bile Duct, Cyst 1 1
Bile Duct, Hyperplasia 41 [2.2] 42 [2.1] 42 [1.9] 38 [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 9
NTP Experiment-Test: 93029-03 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 LEUKOMALACHITE GREEN Time: 15:15:27
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS-NCTR MALE 0 PPM 91 PPM 272 PPM 543 PPM
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Centrilobular, Necrosis 1 [2.0] 1 [3.0] 3 [2.7]
Mesentery (5) (3) (6) (3)
Accessory Spleen 2
Polyarteritis 2 [2.5] 1 [3.0]
Fat, Necrosis 3 [2.3] 3 [2.3] 2 [2.5] 2 [3.0]
Pancreas (48) (47) (48) (47)
Accessory Spleen 1 1
Hyperplasia 1 [3.0]
Infiltration Cellular, Lymphocyte 1 [1.0] 2 [1.0] 2 [1.5] 1 [2.0]
Polyarteritis 1 [3.0]
Acinus, Atrophy 28 [1.9] 16 [1.9] 24 [1.7] 22 [1.9]
Artery, Inflammation, Chronic 1 [3.0] 2 [2.0] 4 [3.0]
Artery, Media, Hypertrophy 1 [3.0] 1 [3.0]
Salivary Glands (48) (47) (48) (47)
Atrophy 1 [2.0]
Stomach (48) (47) (47) (47)
Forestomach, Edema 2 [3.0] 1 [3.0] 2 [2.5]
Forestomach, Inflammation 2 [2.0] 1 [2.0] 1 [2.0] 2 [2.0]
Forestomach, Necrosis 1 [2.0]
Forestomach, Epithelium, Hyperplasia 1 [1.0] 1 [2.0] 2 [2.5]
Glandular, Edema 1 [3.0] 1 [3.0]
Glandular, Erosion 1 [2.0] 1 [2.0]
Glandular, Mineralization 1 [2.0]
Tooth (1)
Gingiva, Hyperplasia 1 [3.0]
Gingiva, Inflammation 1 [2.0]
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (48) (47) (48) (47)
Cardiomyopathy 37 [1.9] 36 [1.9] 40 [1.9] 40 [1.9]
Atrium, Thrombosis 1 2 3
Myocardium, Infarct 1 [2.0]
Ventricle Right, Dilatation 1 [3.0]
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Gland (48) (47) (48) (47)
Degeneration 1 [3.0]
Cortex, Accessory Adrenal Cortical Nodule 2 1
Cortex, Cytoplasmic Alteration 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 10
NTP Experiment-Test: 93029-03 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 LEUKOMALACHITE GREEN Time: 15:15:27
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS-NCTR MALE 0 PPM 91 PPM 272 PPM 543 PPM
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM - CONT
Cortex, Hyperplasia, Focal 5 [1.6] 3 [1.7] 5 [1.2]
Cortex, Hypertrophy, Focal 1 [1.0] 1 [1.0]
Cortex, Vacuolization Cytoplasmic 1 [2.0] 2 [2.0] 4 [1.5] 2 [2.5]
Medulla, Hyperplasia 1 [1.0] 3 [2.0] 2 [2.0]
Islets, Pancreatic (48) (47) (48) (47)
Hyperplasia 1 [2.0] 1 [1.0] 1 [2.0]
Parathyroid Gland (38) (41) (40) (42)
Hyperplasia, Focal 2 [2.5] 2 [3.0] 1 [3.0]
Pituitary Gland (45) (46) (48) (45)
Angiectasis 2 [1.5] 1 [2.0]
Infiltration Cellular, Histiocytic 1 [2.0]
Pigmentation 1 [2.0]
Pars Distalis, Cyst 2 3 5 3
Pars Distalis, Hyperplasia 1 [2.0] 7 [1.7] 2 [2.0] 7 [2.4]
Pars Intermedia, Cyst 1
Thyroid Gland (47) (47) (48) (46)
Ultimobranchial Cyst 1
C-Cell, Hyperplasia 8 [1.8] 6 [1.7] 3 [2.0] 3 [2.0]
Follicle, Cyst 3 [1.3]
Follicular Cell, Hyperplasia 2 [1.0] 1 [4.0] 3 [2.3] 3 [2.0]
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
Tissue NOS (1) (1)
Abdominal, Pigmentation 1 [2.0]
Abdominal, Fat, Necrosis 1
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Coagulating Gland (46) (45) (47) (46)
Decreased Secretory Fluid 2 [2.5] 3 [2.3]
Inflammation, Suppurative 1 [2.0]
Epididymis (48) (47) (48) (47)
Atrophy 1 [2.0]
Granuloma Sperm 1 [3.0]
Inflammation, Chronic 1 [2.0]
Serosa, Cyst 1
Penis (1)
Thrombosis 1 [3.0]
Preputial Gland (48) (47) (48) (47)
Atrophy 1 [2.0] 3 [1.7]
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 11
NTP Experiment-Test: 93029-03 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 LEUKOMALACHITE GREEN Time: 15:15:27
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS-NCTR MALE 0 PPM 91 PPM 272 PPM 543 PPM
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM - CONT
Hyperplasia 1 [1.0] 1 [2.0] 3 [2.3]
Infiltration Cellular, Chronic 1 [2.0]
Inflammation 35 [2.1] 36 [2.0] 38 [1.9] 29 [2.1]
Duct, Ectasia 7 [2.4] 8 [2.8] 11 [2.5] 9 [2.6]
Prostate (48) (47) (48) (47)
Decreased Secretory Fluid 1 [2.0] 1 [2.0] 1 [2.0]
Inflammation 29 [2.1] 21 [1.8] 22 [1.9] 18 [1.8]
Ventral, Hyperplasia 1 [2.0] 3 [1.3] 1 [2.0] 6 [1.7]
Seminal Vesicle (48) (47) (48) (47)
Atrophy 1 [3.0] 1 [3.0]
Decreased Secretory Fluid 28 [2.3] 31 [2.2] 33 [2.4] 36 [2.2]
Lumen, Distended 1 [3.0]
Serosa, Inflammation, Chronic 1 [3.0]
Testes (48) (47) (48) (47)
Mineralization 1 [1.0] 1 [1.0]
Interstitial Cell, Hyperplasia 17 [1.7] 11 [1.7] 5 [1.6] 3 [1.7]
Seminiferous Tubule, Atrophy 11 [2.5] 7 [2.4] 3 [1.7] 8 [2.8]
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (48) (47) (48) (47)
Atrophy 1 [1.0] 1 [2.0] 1 [2.0]
Hyperplasia 2 [2.0] 2 [3.0]
Myeloid Cell, Hyperplasia 1 [2.0] 2 [2.0] 1 [2.0]
Lymph Node (48) (47) (48) (47)
Infiltration Cellular, Plasma Cell 1 [2.0]
Axillary, Hyperplasia, Lymphoid 1 [2.0]
Deep Cervical, Infiltration Cellular, Plasma
Cell 1 [3.0]
Lumbar, Hematopoietic Cell Proliferation 1 [2.0]
Lumbar, Hyperplasia, Lymphoid 2 [2.0] 1 [2.0] 2 [2.5]
Lumbar, Pigmentation 1 [3.0]
Mandibular, Ectasia 3 [2.7] 5 [2.4] 6 [2.3] 4 [2.5]
Mandibular, Hemorrhage 1 [2.0] 1 [2.0]
Mandibular, Hyperplasia, Lymphoid 2 [2.0] 3 [2.0] 1 [2.0]
Mandibular, Infiltration Cellular, Plasma
Cell 5 [2.0] 6 [2.0] 11 [2.1] 7 [2.3]
Mediastinal, Ectasia 1 [2.0]
Mediastinal, Hemorrhage 1 [2.0] 1 [2.0] 1 [2.0]
Mesenteric, Congestion 1 [2.0]
Mesenteric, Ectasia 4 [2.5] 6 [2.5] 6 [2.7] 1 [2.0]
Mesenteric, Hemorrhage 1 [2.0] 3 [2.3] 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 12
NTP Experiment-Test: 93029-03 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 LEUKOMALACHITE GREEN Time: 15:15:27
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS-NCTR MALE 0 PPM 91 PPM 272 PPM 543 PPM
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - CONT
Mesenteric, Hyperplasia, Lymphoid 1 [2.0] 1 [2.0] 1 [2.0]
Mesenteric, Infiltration Cellular, Plasma
Cell 2 [2.0] 1 [2.0]
Pancreatic, Hyperplasia, Lymphoid 1 [3.0] 1 [2.0]
Pancreatic, Infiltration Cellular, Plasma
Cell 1 [2.0]
Pancreatic, Pigmentation 1 [3.0]
Renal, Hemorrhage 1 [2.0] 2 [2.0]
Renal, Hyperplasia, Lymphoid 2 [2.0]
Renal, Infiltration Cellular, Diffuse,
Histiocytic 1 [3.0]
Spleen (48) (47) (48) (47)
Angiectasis 1 [2.0]
Fibrosis 5 [2.0] 6 [2.7] 1 [2.0] 5 [2.2]
Hematopoietic Cell Proliferation 2 [2.0] 3 [2.0] 1 [3.0] 8 [2.1]
Hyperplasia, Focal 1 [3.0]
Hyperplasia, Lymphoid 1 [2.0] 2 [2.0] 4 [2.0]
Infarct 1 2
Pigmentation 3 [2.7] 2 [2.5] 2 [2.0]
Stromal Hyperplasia 1 [3.0]
Thymus (43) (42) (43) (42)
Ectopic Parathyroid Gland 1 [3.0]
Epithelial Cell, Hyperplasia 1 [2.0]
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (43) (41) (46) (41)
Galactocele 6 1 6 2
Hyperplasia 5 [1.8] 4 [2.3] 4 [2.0] 5 [2.0]
Duct, Dilatation 12 [2.1] 6 [2.3] 3 [2.0] 4 [2.0]
Skin (48) (47) (47) (47)
Abscess 1 [3.0]
Cyst 1
Cyst Epithelial Inclusion 2 2 1
Hyperkeratosis 1 [3.0]
Inflammation 1 [3.0]
Inflammation, Chronic 1 [3.0]
Epidermis, Hyperplasia 1 [3.0] 1 [3.0]
Epidermis, Necrosis 1 [2.0]
Epithelium, Hyperplasia 2 [2.0]
Foot, Inflammation, Chronic 1 [2.0] 1 [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 13
NTP Experiment-Test: 93029-03 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 LEUKOMALACHITE GREEN Time: 15:15:27
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS-NCTR MALE 0 PPM 91 PPM 272 PPM 543 PPM
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (48) (47) (48) (47)
Femur, Fibrous Osteodystrophy 1 [3.0] 2 [1.5]
Sternum, Fibrous Osteodystrophy 1 [2.0]
Skeletal Muscle (48) (47) (48) (47)
Arteriole, Mandibular, Proliferation 1
Fiber, Mandibular, Hypertrophy 1
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (48) (47) (48) (47)
Brain Stem, Hemorrhage 1 [2.0] 2 [3.0]
Brain Stem, Hypothalamus, Compression 9 [2.3] 4 [3.0] 6 [2.2] 1 [3.0]
Cerebrum, Compression 1 [2.0]
Cerebrum, Hemorrhage 1 [3.0]
Cerebrum, Hydrocephalus 1 [3.0]
Cerebrum, Hypothalamus, Compression 1 [3.0]
Spinal Cord (48) (47) (48) (47)
Thoracic, Hemorrhage 1 [2.0]
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (48) (47) (48) (47)
Granuloma 1 [1.0]
Hemorrhage 1 [2.0] 2 [1.5]
Alveolar Epithelium, Hyperplasia 2 [2.5] 2 [2.5] 4 [2.5] 6 [2.5]
Alveolus, Infiltration Cellular, Histiocytic 1 [1.0]
Alveolus, Infiltration Cellular, Histiocyte 3 [1.7] 4 [1.8] 2 [1.0] 4 [1.8]
Alveolus, Inflammation, Multifocal 1 [2.0]
Mediastinum, Hemorrhage 1 [2.0]
Nose (48) (47) (48) (47)
Inflammation, Suppurative 1 [1.0]
Nasolacrimal Duct, Inflammation 10 [1.7] 15 [1.8] 16 [1.8] 12 [1.7]
Nasolacrimal Duct, Mineralization 1 [2.0]
Respiratory Epithelium, Hyperplasia 1 [2.0] 1 [2.0] 1 [2.0]
Respiratory Epithelium, Inflammation, Chronic 1 [2.0]
Septum, Inflammation, Chronic 1 [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 14
NTP Experiment-Test: 93029-03 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 LEUKOMALACHITE GREEN Time: 15:15:27
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS-NCTR MALE 0 PPM 91 PPM 272 PPM 543 PPM
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Ear (1) (2)
Canal, External Ear, Exudate 1 [2.0]
Eye (48) (47) (48) (47)
Cataract 3 [2.3] 3 [1.3] 2 [2.0] 1 [3.0]
Hemorrhage 2 [2.5]
Inflammation 1 [3.0]
Bilateral, Cataract 2 [2.0] 1 [2.0] 3 [1.7]
Bilateral, Retina, Degeneration 1 [1.0] 5 [2.0]
Cornea, Edema 1
Retina, Autolysis 4 5 3 3
Retina, Degeneration 8 [2.4] 3 [1.7] 3 [1.7] 2 [2.0]
Sclera, Metaplasia, Osseous 2 [2.0] 1 [2.0] 1 [2.0]
Harderian Gland (48) (47) (48) (47)
Hyperplasia 1 [2.0]
Infiltration Cellular, Lymphocyte 16 [1.2] 16 [1.3] 16 [1.1] 18 [1.3]
Inflammation 1 [2.0] 1 [1.0] 1 [2.0]
Zymbal's Gland (46) (43) (47) (47)
Hyperplasia 1 [3.0]
Inflammation, Chronic 1 [1.0]
Duct, Ectasia 1 [2.0]
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (48) (47) (48) (47)
Accumulation, Hyaline Droplet 1 [2.0]
Infiltration Cellular, Lymphocyte 1 [2.0]
Nephropathy 43 [1.9] 45 [2.0] 46 [2.2] 47 [2.4]
Pigmentation 3 [2.0] 1 [3.0] 1 [2.0]
Thrombosis 1 [4.0]
Cortex, Cyst 1 1
Renal Tubule, Hyperplasia 1 [2.0]
Urinary Bladder (48) (47) (48) (47)
Calculus Micro Observation Only 1
Hemorrhage 1 [3.0]
Inflammation 1 [3.0]
Artery, Inflammation 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 15
------------------------------------------------------------
---------- END OF REPORT ----------
------------------------------------------------------------