TDMS Study 93029-03 Pathology Tables
NTP Experiment-Test: 93029-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC LEUKOMALACHITE GREEN Date: 06/18/03
Route: DOSED FEED Time: 14:39:48
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: 93029-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC LEUKOMALACHITE GREEN Date: 06/18/03
Route: DOSED FEED Time: 14:39:48
____________________________________________________________________________________________________________________________________
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 (2%)
Cecum, Lymphoid Tissue, Hyperplasia 1 (2%)
Colon, Lymphoid Tissue, Hyperplasia 1 (2%) 1 (2%) 1 (2%)
Rectum, Inflammation 1 (2%)
Intestine Small (48) (48) (48) (48)
Ileum, Dilatation 1 (2%)
Ileum, Inflammation 1 (2%)
Ileum, Lymphoid Tissue, Hyperplasia 1 (2%) 2 (4%) 1 (2%)
Liver (48) (48) (48) (48)
Angiectasis 1 (2%)
Basophilic Focus 3 (6%) 4 (8%) 2 (4%) 1 (2%)
Basophilic Focus, Multiple 20 (42%) 26 (54%) 2 (4%)
Degeneration, Cystic 3 (6%) 2 (4%) 5 (10%) 3 (6%)
Developmental Malformation 7 (15%) 5 (10%) 3 (6%) 5 (10%)
Eosinophilic Focus 3 (6%) 4 (8%) 13 (27%) 5 (10%)
Eosinophilic Focus, Multiple 8 (17%) 7 (15%) 11 (23%)
Hematopoietic Cell Proliferation 1 (2%) 1 (2%) 3 (6%) 1 (2%)
Hepatodiaphragmatic Nodule 4 (8%) 1 (2%) 5 (10%) 1 (2%)
Infiltration Cellular, Lymphocyte 2 (4%) 3 (6%) 7 (15%) 4 (8%)
Inflammation, Focal, Granulomatous 10 (21%) 19 (40%) 20 (42%) 13 (27%)
Mixed Cell Focus 1 (2%)
Necrosis 4 (8%) 2 (4%) 1 (2%) 3 (6%)
Tension Lipidosis 1 (2%) 2 (4%)
Tension Lipidosis, Multiple 1 (2%)
Vacuolization Cytoplasmic 5 (10%) 5 (10%) 17 (35%) 22 (46%)
Bile Duct, Cyst 2 (4%)
Bile Duct, Hyperplasia 16 (33%) 18 (38%) 19 (40%) 18 (38%)
Centrilobular, Necrosis 1 (2%) 2 (4%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 2
NTP Experiment-Test: 93029-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC LEUKOMALACHITE GREEN Date: 06/18/03
Route: DOSED FEED Time: 14:39:48
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS-NCTR FEMALE 0 PPM 91 PPM 272 PPM 543 PPM
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Mesentery (8) (7) (1) (4)
Accessory Spleen 2 (29%) 1 (25%)
Fat, Necrosis 6 (75%) 5 (71%) 1 (100%) 3 (75%)
Pancreas (48) (48) (47) (48)
Infiltration Cellular, Lymphocyte 2 (4%) 3 (6%) 1 (2%)
Inflammation 1 (2%) 1 (2%)
Acinus, Atrophy 20 (42%) 16 (33%) 17 (36%) 18 (38%)
Salivary Glands (48) (48) (48) (48)
Atrophy 2 (4%) 1 (2%)
Infiltration Cellular, Lymphocyte 1 (2%)
Parotid Gland, Hypertrophy, Focal 1 (2%)
Stomach (48) (48) (48) (48)
Forestomach, Edema 1 (2%)
Forestomach, Inflammation 2 (4%) 1 (2%) 1 (2%)
Forestomach, Epithelium, Hyperplasia 2 (4%) 1 (2%)
Glandular, Edema 1 (2%)
Tongue (48) (48) (48) (48)
Epithelium, Hyperplasia, Focal 1 (2%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (48) (48) (48) (48)
Cardiomyopathy 35 (73%) 35 (73%) 33 (69%) 30 (63%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Gland (47) (48) (47) (48)
Cortex, Accessory Adrenal Cortical Nodule 3 (6%)
Cortex, Angiectasis 8 (17%) 10 (21%) 2 (4%) 3 (6%)
Cortex, Atrophy 1 (2%)
Cortex, Degeneration 1 (2%)
Cortex, Hyperplasia, Focal 4 (9%) 2 (4%) 4 (9%) 5 (10%)
Cortex, Hypertrophy, Focal 2 (4%) 2 (4%)
Cortex, Thrombosis 1 (2%)
Cortex, Vacuolization Cytoplasmic 2 (4%) 1 (2%)
Medulla, Hyperplasia 1 (2%)
Pituitary Gland (47) (47) (45) (46)
Angiectasis 3 (6%) 1 (2%) 1 (2%) 2 (4%)
Pars Distalis, Cyst 8 (17%) 4 (9%) 6 (13%) 1 (2%)
Pars Distalis, Hyperplasia 2 (4%) 4 (9%) 4 (9%) 5 (11%)
Thyroid Gland (46) (46) (47) (48)
a Number of animals examined microscopically at site and number of animals with lesion
Page 3
NTP Experiment-Test: 93029-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC LEUKOMALACHITE GREEN Date: 06/18/03
Route: DOSED FEED Time: 14:39:48
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS-NCTR FEMALE 0 PPM 91 PPM 272 PPM 543 PPM
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM - CONT
C-Cell, Hyperplasia 13 (28%) 5 (11%) 6 (13%) 1 (2%)
Follicle, Cyst 1 (2%) 2 (4%)
Follicular Cell, Hyperplasia 1 (2%) 3 (6%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Clitoral Gland (47) (47) (46) (47)
Hyperplasia 4 (9%) 4 (9%) 5 (11%) 3 (6%)
Inflammation 23 (49%) 31 (66%) 22 (48%) 28 (60%)
Duct, Dilatation 25 (53%) 24 (51%) 18 (39%) 15 (32%)
Duct, Hyperplasia 1 (2%)
Ovary (48) (48) (48) (48)
Atrophy 6 (13%) 5 (10%) 10 (21%) 7 (15%)
Cyst 8 (17%) 5 (10%) 10 (21%) 4 (8%)
Infiltration Cellular, Lymphocyte 3 (6%) 3 (6%) 3 (6%)
Periovarian Tissue, Hemorrhage 1 (2%)
Uterus (48) (48) (48) (48)
Decidual Reaction 1 (2%) 1 (2%)
Hemorrhage 1 (2%) 1 (2%)
Inflammation 1 (2%)
Thrombosis 1 (2%)
Bilateral, Horn, Dilatation 1 (2%)
Cervix, Hypertrophy 5 (10%) 5 (10%) 2 (4%) 5 (10%)
Endometrium, Hyperplasia 1 (2%)
Endometrium, Hyperplasia, Cystic 3 (6%) 3 (6%) 4 (8%) 7 (15%)
Vagina (48) (48) (48) (48)
Cyst 1 (2%)
Exudate, Mucous 1 (2%) 1 (2%)
Hemorrhage 1 (2%)
Inflammation, Suppurative 3 (6%) 2 (4%) 1 (2%) 2 (4%)
Metaplasia, Squamous 1 (2%)
Prolapse 1 (2%)
____________________________________________________________________________________________________________________________________
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: 93029-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC LEUKOMALACHITE GREEN Date: 06/18/03
Route: DOSED FEED Time: 14:39:48
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS-NCTR FEMALE 0 PPM 91 PPM 272 PPM 543 PPM
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - CONT
Atrophy 4 (8%) 2 (4%) 4 (8%) 3 (6%)
Myelostromal Proliferation 1 (2%)
Myeloid Cell, Hyperplasia 1 (2%)
Lymph Node (48) (48) (48) (48)
Hyperplasia, Lymphoid 1 (2%)
Bronchial, Hyperplasia, Lymphoid 1 (2%)
Lumbar, Ectasia 1 (2%)
Lumbar, Hyperplasia, Lymphoid 1 (2%)
Mandibular, Ectasia 2 (4%) 2 (4%)
Mandibular, Hyperplasia, Lymphoid 1 (2%) 1 (2%) 4 (8%) 1 (2%)
Mandibular, Infiltration Cellular, Plasma
Cell 4 (8%) 8 (17%) 4 (8%)
Mediastinal, Ectasia 1 (2%) 1 (2%)
Mediastinal, Hemorrhage 1 (2%) 3 (6%) 1 (2%)
Mediastinal, Hyperplasia, Lymphoid 1 (2%) 1 (2%) 1 (2%)
Mediastinal, Infiltration Cellular, Plasma
Cell 1 (2%)
Mesenteric, Angiectasis 1 (2%)
Mesenteric, Ectasia 2 (4%) 1 (2%) 4 (8%) 2 (4%)
Mesenteric, Hemorrhage 1 (2%) 2 (4%)
Mesenteric, Hyperplasia, Lymphoid 1 (2%) 2 (4%) 2 (4%)
Pancreatic, Ectasia 1 (2%)
Pancreatic, Hemorrhage 1 (2%) 1 (2%)
Pancreatic, Hyperplasia, Lymphoid 1 (2%) 2 (4%) 1 (2%)
Renal, Ectasia 1 (2%)
Renal, Hemorrhage 1 (2%)
Renal, Hyperplasia, Lymphoid 2 (4%) 1 (2%)
Spleen (48) (48) (48) (48)
Angiectasis 1 (2%)
Fibrosis 1 (2%)
Hematopoietic Cell Proliferation 3 (6%) 4 (8%) 6 (13%) 5 (10%)
Hyperplasia, Focal 1 (2%)
Pigmentation 1 (2%) 2 (4%) 3 (6%) 1 (2%)
Stromal Hyperplasia 1 (2%)
Thymus (41) (47) (44) (42)
Cyst 2 (4%) 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (48) (46) (48) (48)
Galactocele 7 (15%) 2 (4%)
Hyperplasia 25 (52%) 20 (43%) 19 (40%) 22 (46%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 5
NTP Experiment-Test: 93029-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC LEUKOMALACHITE GREEN Date: 06/18/03
Route: DOSED FEED Time: 14:39:48
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS-NCTR FEMALE 0 PPM 91 PPM 272 PPM 543 PPM
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM - CONT
Infiltration Cellular, Lymphocyte 1 (2%)
Duct, Dilatation 10 (21%) 13 (28%) 7 (15%) 3 (6%)
Skin (48) (48) (48) (48)
Abscess 1 (2%)
Hyperkeratosis, Multifocal 1 (2%)
Inflammation 2 (4%) 1 (2%) 1 (2%)
Epidermis, Hyperplasia 3 (6%) 1 (2%) 3 (6%) 3 (6%)
Epidermis, Necrosis 1 (2%) 1 (2%) 2 (4%) 3 (6%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (48) (48) (48) (48)
Cranium, Osteopetrosis 1 (2%)
Femur, Fibrous Osteodystrophy 2 (4%)
Femur, Fracture Healed 1 (2%)
Femur, Osteopetrosis 1 (2%) 4 (8%) 3 (6%) 1 (2%)
Mandible, Osteopetrosis 1 (2%)
Maxilla, Inflammation, Chronic 1 (2%)
Sternum, Fibrous Osteodystrophy 1 (2%) 1 (2%)
Sternum, Osteopetrosis 1 (2%) 4 (8%) 4 (8%) 1 (2%)
Turbinate, Osteopetrosis 1 (2%) 3 (6%) 4 (8%) 1 (2%)
Skeletal Muscle (48) (48) (48) (48)
Mineralization, Multifocal 1 (2%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (48) (48) (48) (48)
Brain Stem, Hemorrhage 1 (2%)
Brain Stem, Hypothalamus, Compression 11 (23%) 6 (13%) 5 (10%) 5 (10%)
Cerebrum, Hemorrhage 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (48) (48) (48) (48)
Infiltration Cellular, Lymphocyte 1 (2%)
Alveolar Epithelium, Hyperplasia 3 (6%) 1 (2%) 2 (4%)
Alveolar Epithelium, Metaplasia, Focal,
Squamous 1 (2%)
Alveolus, Infiltration Cellular, Multifocal 1 (2%)
Alveolus, Infiltration Cellular, Histiocyte 4 (8%) 3 (6%) 10 (21%) 6 (13%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 6
NTP Experiment-Test: 93029-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC LEUKOMALACHITE GREEN Date: 06/18/03
Route: DOSED FEED Time: 14:39:48
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS-NCTR FEMALE 0 PPM 91 PPM 272 PPM 543 PPM
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM - CONT
Alveolus, Inflammation, Multifocal 1 (2%) 1 (2%)
Nose (48) (48) (48) (48)
Inflammation, Suppurative 1 (2%)
Nasolacrimal Duct, Cyst Epithelial Inclusion 1 (2%)
Nasolacrimal Duct, Inflammation 21 (44%) 19 (40%) 18 (38%) 19 (40%)
Respiratory Epithelium, Concretion 1 (2%)
Trachea (48) (48) (48) (48)
Inflammation, Chronic 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (48) (48) (48) (48)
Cataract 2 (4%) 5 (10%)
Phthisis Bulbi 1 (2%) 1 (2%) 2 (4%)
Bilateral, Cataract 1 (2%) 1 (2%) 2 (4%)
Bilateral, Retina, Degeneration 4 (8%) 4 (8%) 5 (10%) 7 (15%)
Conjunctiva, Inflammation 1 (2%)
Cornea, Neovascularization 1 (2%)
Retina, Autolysis 5 (10%) 1 (2%) 1 (2%) 3 (6%)
Retina, Degeneration 3 (6%) 6 (13%) 9 (19%)
Sclera, Metaplasia, Osseous 1 (2%)
Harderian Gland (48) (48) (48) (48)
Hyperplasia 1 (2%)
Infiltration Cellular, Focal, Histiocyte 1 (2%)
Infiltration Cellular, Lymphocyte 19 (40%) 26 (54%) 22 (46%) 21 (44%)
Inflammation 1 (2%)
Lacrimal Gland (10) (6) (8) (4)
Infiltration Cellular, Lymphocyte 3 (30%) 1 (17%) 2 (50%)
Metaplasia 10 (100%) 6 (100%) 8 (100%) 4 (100%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (48) (48) (48) (48)
Hydronephrosis 1 (2%) 1 (2%)
Infarct 1 (2%)
Infiltration Cellular, Lymphocyte 1 (2%)
Mineralization 47 (98%) 46 (96%) 47 (98%) 48 (100%)
Necrosis, Focal 1 (2%)
Nephropathy 34 (71%) 31 (65%) 27 (56%) 29 (60%)
Pigmentation 2 (4%) 2 (4%)
Urinary Bladder (47) (47) (48) (48)
a Number of animals examined microscopically at site and number of animals with lesion
Page 7
NTP Experiment-Test: 93029-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC LEUKOMALACHITE GREEN Date: 06/18/03
Route: DOSED FEED Time: 14:39:48
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS-NCTR FEMALE 0 PPM 91 PPM 272 PPM 543 PPM
____________________________________________________________________________________________________________________________________
URINARY SYSTEM - CONT
Hemorrhage 1 (2%)
Infiltration Cellular, Lymphocyte 1 (2%) 1 (2%) 2 (4%)
Inflammation 2 (4%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 8
NTP Experiment-Test: 93029-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC LEUKOMALACHITE GREEN Date: 06/18/03
Route: DOSED FEED Time: 14:39:48
____________________________________________________________________________________________________________________________________
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 (2%)
Cecum, Lymphoid Tissue, Hyperplasia 3 (6%) 1 (2%)
Colon, Lymphoid Tissue, Hyperplasia 2 (4%) 1 (2%)
Intestine Small (47) (47) (48) (47)
Duodenum, Autolysis 1 (2%)
Ileum, Hyperplasia 1 (2%)
Ileum, Inflammation 1 (2%)
Ileum, Lymphoid Tissue, Hyperplasia 4 (9%) 1 (2%) 1 (2%) 3 (6%)
Jejunum, Autolysis 1 (2%)
Jejunum, Diverticulum 1 (2%)
Jejunum, Lymphoid Tissue, Hyperplasia 1 (2%) 2 (4%)
Liver (48) (47) (48) (47)
Basophilic Focus 2 (4%) 2 (4%)
Degeneration, Cystic 4 (8%) 18 (38%) 13 (27%) 19 (40%)
Developmental Malformation 1 (2%) 1 (2%) 1 (2%)
Eosinophilic Focus 2 (4%) 8 (17%) 9 (19%) 8 (17%)
Eosinophilic Focus, Multiple 1 (2%) 6 (13%) 10 (21%) 25 (53%)
Hematopoietic Cell Proliferation 1 (2%)
Hepatodiaphragmatic Nodule 2 (4%) 2 (4%) 3 (6%)
Infiltration Cellular, Lymphocyte 1 (2%)
Inflammation, Focal, Granulomatous 3 (6%) 1 (2%) 1 (2%) 1 (2%)
Mixed Cell Focus 1 (2%) 2 (4%)
Necrosis 1 (2%) 1 (2%)
Pigmentation 1 (2%)
Vacuolization Cytoplasmic 9 (19%) 21 (45%) 10 (21%) 13 (28%)
Bile Duct, Cyst 1 (2%) 1 (2%)
Bile Duct, Hyperplasia 41 (85%) 42 (89%) 42 (88%) 38 (81%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 9
NTP Experiment-Test: 93029-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC LEUKOMALACHITE GREEN Date: 06/18/03
Route: DOSED FEED Time: 14:39:48
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS-NCTR MALE 0 PPM 91 PPM 272 PPM 543 PPM
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Centrilobular, Necrosis 1 (2%) 1 (2%) 3 (6%)
Mesentery (5) (3) (6) (3)
Accessory Spleen 2 (33%)
Polyarteritis 2 (33%) 1 (33%)
Fat, Necrosis 3 (60%) 3 (100%) 2 (33%) 2 (67%)
Pancreas (48) (47) (48) (47)
Accessory Spleen 1 (2%) 1 (2%)
Hyperplasia 1 (2%)
Infiltration Cellular, Lymphocyte 1 (2%) 2 (4%) 2 (4%) 1 (2%)
Polyarteritis 1 (2%)
Acinus, Atrophy 28 (58%) 16 (34%) 24 (50%) 22 (47%)
Artery, Inflammation, Chronic 1 (2%) 2 (4%) 4 (9%)
Artery, Media, Hypertrophy 1 (2%) 1 (2%)
Salivary Glands (48) (47) (48) (47)
Atrophy 1 (2%)
Stomach (48) (47) (47) (47)
Forestomach, Edema 2 (4%) 1 (2%) 2 (4%)
Forestomach, Inflammation 2 (4%) 1 (2%) 1 (2%) 2 (4%)
Forestomach, Necrosis 1 (2%)
Forestomach, Epithelium, Hyperplasia 1 (2%) 1 (2%) 2 (4%)
Glandular, Edema 1 (2%) 1 (2%)
Glandular, Erosion 1 (2%) 1 (2%)
Glandular, Mineralization 1 (2%)
Tooth (1)
Gingiva, Hyperplasia 1 (100%)
Gingiva, Inflammation 1 (100%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (48) (47) (48) (47)
Cardiomyopathy 37 (77%) 36 (77%) 40 (83%) 40 (85%)
Atrium, Thrombosis 1 (2%) 2 (4%) 3 (6%)
Myocardium, Infarct 1 (2%)
Ventricle Right, Dilatation 1 (2%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Gland (48) (47) (48) (47)
Degeneration 1 (2%)
Cortex, Accessory Adrenal Cortical Nodule 2 (4%) 1 (2%)
Cortex, Cytoplasmic Alteration 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 10
NTP Experiment-Test: 93029-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC LEUKOMALACHITE GREEN Date: 06/18/03
Route: DOSED FEED Time: 14:39:48
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS-NCTR MALE 0 PPM 91 PPM 272 PPM 543 PPM
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM - CONT
Cortex, Hyperplasia, Focal 5 (11%) 3 (6%) 5 (11%)
Cortex, Hypertrophy, Focal 1 (2%) 1 (2%)
Cortex, Vacuolization Cytoplasmic 1 (2%) 2 (4%) 4 (8%) 2 (4%)
Medulla, Hyperplasia 1 (2%) 3 (6%) 2 (4%)
Islets, Pancreatic (48) (47) (48) (47)
Hyperplasia 1 (2%) 1 (2%) 1 (2%)
Parathyroid Gland (38) (41) (40) (42)
Hyperplasia, Focal 2 (5%) 2 (5%) 1 (2%)
Pituitary Gland (45) (46) (48) (45)
Angiectasis 2 (4%) 1 (2%)
Infiltration Cellular, Histiocytic 1 (2%)
Pigmentation 1 (2%)
Pars Distalis, Cyst 2 (4%) 3 (7%) 5 (10%) 3 (7%)
Pars Distalis, Hyperplasia 1 (2%) 7 (15%) 2 (4%) 7 (16%)
Pars Intermedia, Cyst 1 (2%)
Thyroid Gland (47) (47) (48) (46)
Ultimobranchial Cyst 1 (2%)
C-Cell, Hyperplasia 8 (17%) 6 (13%) 3 (6%) 3 (7%)
Follicle, Cyst 3 (7%)
Follicular Cell, Hyperplasia 2 (4%) 1 (2%) 3 (6%) 3 (7%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
Tissue NOS (1) (1)
Abdominal, Pigmentation 1 (100%)
Abdominal, Fat, Necrosis 1 (100%)
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Coagulating Gland (46) (45) (47) (46)
Decreased Secretory Fluid 2 (4%) 3 (7%)
Inflammation, Suppurative 1 (2%)
Epididymis (48) (47) (48) (47)
Atrophy 1 (2%)
Granuloma Sperm 1 (2%)
Inflammation, Chronic 1 (2%)
Serosa, Cyst 1 (2%)
Penis (1)
Thrombosis 1 (100%)
Preputial Gland (48) (47) (48) (47)
Atrophy 1 (2%) 3 (6%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 11
NTP Experiment-Test: 93029-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC LEUKOMALACHITE GREEN Date: 06/18/03
Route: DOSED FEED Time: 14:39:48
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS-NCTR MALE 0 PPM 91 PPM 272 PPM 543 PPM
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM - CONT
Hyperplasia 1 (2%) 1 (2%) 3 (6%)
Infiltration Cellular, Chronic 1 (2%)
Inflammation 35 (73%) 36 (77%) 38 (79%) 29 (62%)
Duct, Ectasia 7 (15%) 8 (17%) 11 (23%) 9 (19%)
Prostate (48) (47) (48) (47)
Decreased Secretory Fluid 1 (2%) 1 (2%) 1 (2%)
Inflammation 29 (60%) 21 (45%) 22 (46%) 18 (38%)
Ventral, Hyperplasia 1 (2%) 3 (6%) 1 (2%) 6 (13%)
Seminal Vesicle (48) (47) (48) (47)
Atrophy 1 (2%) 1 (2%)
Decreased Secretory Fluid 28 (58%) 31 (66%) 33 (69%) 36 (77%)
Lumen, Distended 1 (2%)
Serosa, Inflammation, Chronic 1 (2%)
Testes (48) (47) (48) (47)
Mineralization 1 (2%) 1 (2%)
Interstitial Cell, Hyperplasia 17 (35%) 11 (23%) 5 (10%) 3 (6%)
Seminiferous Tubule, Atrophy 11 (23%) 7 (15%) 3 (6%) 8 (17%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (48) (47) (48) (47)
Atrophy 1 (2%) 1 (2%) 1 (2%)
Hyperplasia 2 (4%) 2 (4%)
Myeloid Cell, Hyperplasia 1 (2%) 2 (4%) 1 (2%)
Lymph Node (48) (47) (48) (47)
Infiltration Cellular, Plasma Cell 1 (2%)
Axillary, Hyperplasia, Lymphoid 1 (2%)
Deep Cervical, Infiltration Cellular, Plasma
Cell 1 (2%)
Lumbar, Hematopoietic Cell Proliferation 1 (2%)
Lumbar, Hyperplasia, Lymphoid 2 (4%) 1 (2%) 2 (4%)
Lumbar, Pigmentation 1 (2%)
Mandibular, Ectasia 3 (6%) 5 (11%) 6 (13%) 4 (9%)
Mandibular, Hemorrhage 1 (2%) 1 (2%)
Mandibular, Hyperplasia, Lymphoid 2 (4%) 3 (6%) 1 (2%)
Mandibular, Infiltration Cellular, Plasma
Cell 5 (10%) 6 (13%) 11 (23%) 7 (15%)
Mediastinal, Ectasia 1 (2%)
Mediastinal, Hemorrhage 1 (2%) 1 (2%) 1 (2%)
Mesenteric, Congestion 1 (2%)
Mesenteric, Ectasia 4 (8%) 6 (13%) 6 (13%) 1 (2%)
Mesenteric, Hemorrhage 1 (2%) 3 (6%) 2 (4%) 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 12
NTP Experiment-Test: 93029-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC LEUKOMALACHITE GREEN Date: 06/18/03
Route: DOSED FEED Time: 14:39:48
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS-NCTR MALE 0 PPM 91 PPM 272 PPM 543 PPM
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - CONT
Mesenteric, Hyperplasia, Lymphoid 1 (2%) 1 (2%) 1 (2%)
Mesenteric, Infiltration Cellular, Plasma
Cell 2 (4%) 1 (2%)
Pancreatic, Hyperplasia, Lymphoid 1 (2%) 1 (2%)
Pancreatic, Infiltration Cellular, Plasma
Cell 1 (2%)
Pancreatic, Pigmentation 1 (2%)
Renal, Hemorrhage 1 (2%) 2 (4%)
Renal, Hyperplasia, Lymphoid 2 (4%)
Renal, Infiltration Cellular, Diffuse,
Histiocytic 1 (2%)
Spleen (48) (47) (48) (47)
Angiectasis 1 (2%)
Fibrosis 5 (10%) 6 (13%) 1 (2%) 5 (11%)
Hematopoietic Cell Proliferation 2 (4%) 3 (6%) 1 (2%) 8 (17%)
Hyperplasia, Focal 1 (2%)
Hyperplasia, Lymphoid 1 (2%) 2 (4%) 4 (9%)
Infarct 1 (2%) 2 (4%)
Pigmentation 3 (6%) 2 (4%) 2 (4%)
Stromal Hyperplasia 1 (2%)
Thymus (43) (42) (43) (42)
Ectopic Parathyroid Gland 1 (2%)
Epithelial Cell, Hyperplasia 1 (2%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (43) (41) (46) (41)
Galactocele 6 (14%) 1 (2%) 6 (13%) 2 (5%)
Hyperplasia 5 (12%) 4 (10%) 4 (9%) 5 (12%)
Duct, Dilatation 12 (28%) 6 (15%) 3 (7%) 4 (10%)
Skin (48) (47) (47) (47)
Abscess 1 (2%)
Cyst 1 (2%)
Cyst Epithelial Inclusion 2 (4%) 2 (4%) 1 (2%)
Hyperkeratosis 1 (2%)
Inflammation 1 (2%)
Inflammation, Chronic 1 (2%)
Epidermis, Hyperplasia 1 (2%) 1 (2%)
Epidermis, Necrosis 1 (2%)
Epithelium, Hyperplasia 2 (4%)
Foot, Inflammation, Chronic 1 (2%) 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 13
NTP Experiment-Test: 93029-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC LEUKOMALACHITE GREEN Date: 06/18/03
Route: DOSED FEED Time: 14:39:48
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS-NCTR MALE 0 PPM 91 PPM 272 PPM 543 PPM
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (48) (47) (48) (47)
Femur, Fibrous Osteodystrophy 1 (2%) 2 (4%)
Sternum, Fibrous Osteodystrophy 1 (2%)
Skeletal Muscle (48) (47) (48) (47)
Arteriole, Mandibular, Proliferation 1 (2%)
Fiber, Mandibular, Hypertrophy 1 (2%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (48) (47) (48) (47)
Brain Stem, Hemorrhage 1 (2%) 2 (4%)
Brain Stem, Hypothalamus, Compression 9 (19%) 4 (9%) 6 (13%) 1 (2%)
Cerebrum, Compression 1 (2%)
Cerebrum, Hemorrhage 1 (2%)
Cerebrum, Hydrocephalus 1 (2%)
Cerebrum, Hypothalamus, Compression 1 (2%)
Spinal Cord (48) (47) (48) (47)
Thoracic, Hemorrhage 1 (2%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (48) (47) (48) (47)
Granuloma 1 (2%)
Hemorrhage 1 (2%) 2 (4%)
Alveolar Epithelium, Hyperplasia 2 (4%) 2 (4%) 4 (8%) 6 (13%)
Alveolus, Infiltration Cellular, Histiocytic 1 (2%)
Alveolus, Infiltration Cellular, Histiocyte 3 (6%) 4 (9%) 2 (4%) 4 (9%)
Alveolus, Inflammation, Multifocal 1 (2%)
Mediastinum, Hemorrhage 1 (2%)
Nose (48) (47) (48) (47)
Inflammation, Suppurative 1 (2%)
Nasolacrimal Duct, Inflammation 10 (21%) 15 (32%) 16 (33%) 12 (26%)
Nasolacrimal Duct, Mineralization 1 (2%)
Respiratory Epithelium, Hyperplasia 1 (2%) 1 (2%) 1 (2%)
Respiratory Epithelium, Inflammation, Chronic 1 (2%)
Septum, Inflammation, Chronic 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 14
NTP Experiment-Test: 93029-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC LEUKOMALACHITE GREEN Date: 06/18/03
Route: DOSED FEED Time: 14:39:48
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS-NCTR MALE 0 PPM 91 PPM 272 PPM 543 PPM
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Ear (1) (2)
Canal, External Ear, Exudate 1 (50%)
Eye (48) (47) (48) (47)
Cataract 3 (6%) 3 (6%) 2 (4%) 1 (2%)
Hemorrhage 2 (4%)
Inflammation 1 (2%)
Bilateral, Cataract 2 (4%) 1 (2%) 3 (6%)
Bilateral, Retina, Degeneration 1 (2%) 5 (11%)
Cornea, Edema 1 (2%)
Retina, Autolysis 4 (8%) 5 (11%) 3 (6%) 3 (6%)
Retina, Degeneration 8 (17%) 3 (6%) 3 (6%) 2 (4%)
Sclera, Metaplasia, Osseous 2 (4%) 1 (2%) 1 (2%)
Harderian Gland (48) (47) (48) (47)
Hyperplasia 1 (2%)
Infiltration Cellular, Lymphocyte 16 (33%) 16 (34%) 16 (33%) 18 (38%)
Inflammation 1 (2%) 1 (2%) 1 (2%)
Zymbal's Gland (46) (43) (47) (47)
Hyperplasia 1 (2%)
Inflammation, Chronic 1 (2%)
Duct, Ectasia 1 (2%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (48) (47) (48) (47)
Accumulation, Hyaline Droplet 1 (2%)
Infiltration Cellular, Lymphocyte 1 (2%)
Nephropathy 43 (90%) 45 (96%) 46 (96%) 47 (100%)
Pigmentation 3 (6%) 1 (2%) 1 (2%)
Thrombosis 1 (2%)
Cortex, Cyst 1 (2%) 1 (2%)
Renal Tubule, Hyperplasia 1 (2%)
Urinary Bladder (48) (47) (48) (47)
Calculus Micro Observation Only 1 (2%)
Hemorrhage 1 (2%)
Inflammation 1 (2%)
Artery, Inflammation 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 15
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