TDMS Study 93005-04 Pathology Tables
NTP Experiment-Test: 93005-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18 Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 06/19/03 Route: DOSED FEED MALACHITE GREEN Time: 07:29:07 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: 93005-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18 Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 06/19/03 Route: DOSED FEED MALACHITE GREEN Time: 07:29:07 ____________________________________________________________________________________________________________________________________ C57BL/6N XC3H/HEN MTN-NCTR FEMALE 0 PPM 100 PPM 225 PPM 450 PPM ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 48 48 48 48 Early Deaths Natural Death 4 1 4 3 Accidently Killed 1 Moribund Sacrifice 4 3 3 4 Survivors Terminal Sacrifice 40 44 40 41 Animals Examined Microscopically 48 48 48 48 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Cecum (46) (47) (45) (46) Hyperplasia, Lymphoid 1 [2.0] Intestine Small, Jejunum (46) (47) (44) (47) Hyperplasia, Lymphoid 1 [4.0] Liver (48) (48) (46) (48) Basophilic Focus 1 1 3 Fatty Change, Focal 1 [2.0] Hematopoietic Cell Proliferation 2 [1.0] 1 [2.0] 2 [1.0] Infiltration Cellular, Lymphocyte 4 [1.0] 6 [1.3] 8 [1.6] 12 [1.2] Infiltration Cellular, Histiocyte 1 [2.0] Inflammation, Chronic Active, Focal 5 [1.4] 9 [1.1] 8 [1.0] 4 [1.0] Necrosis 2 [2.5] Tension Lipidosis 10 [1.2] 7 [1.3] 8 [1.5] 6 [1.5] Bile Duct, Cyst 1 [3.0] Mesentery (2) (5) (1) Infiltration Cellular, Lymphocyte 1 [3.0] Fat, Necrosis, Focal 2 [2.5] 3 [1.7] 1 [2.0] Pancreas (47) (47) (44) (47) Cyst 1 [2.0] Cytoplasmic Alteration 1 [1.0] 1 [1.0] 1 [1.0] Infiltration Cellular, Lymphocyte 6 [1.7] 4 [1.5] 2 [1.5] 3 [1.7] Necrosis, Focal 1 [2.0] Acinus, Atrophy 2 [2.5] Salivary Glands (48) (48) (48) (48) Infiltration Cellular, Mononuclear Cell 1 [1.0] Parotid Gland, Infiltration Cellular, Lymphocyte 5 [1.6] 12 [1.6] 4 [1.3] 5 [1.4] Sublingual Gland, Infiltration Cellular, Lymphocyte 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 2 NTP Experiment-Test: 93005-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18 Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 06/19/03 Route: DOSED FEED MALACHITE GREEN Time: 07:29:07 ____________________________________________________________________________________________________________________________________ C57BL/6N XC3H/HEN MTN-NCTR FEMALE 0 PPM 100 PPM 225 PPM 450 PPM ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Submandibular Gland, Infiltration Cellular, Lymphocyte 35 [1.5] 28 [1.6] 28 [1.8] 28 [1.8] Stomach, Forestomach (47) (47) (46) (48) Hyperkeratosis, Focal 1 [1.0] Infiltration Cellular, Mast Cell 1 [2.0] Inflammation, Chronic Active 2 [1.0] 3 [1.0] 2 [1.5] 1 [2.0] Ulcer 1 [2.0] Epithelium, Hyperplasia, Diffuse 2 [2.0] 2 [1.0] 1 [1.0] Epithelium, Hyperplasia, Focal 11 [1.5] 8 [1.8] 4 [1.8] 7 [1.7] Stomach, Glandular (47) (47) (46) (48) Erosion 1 [2.0] 1 [2.0] Ulcer 1 [2.0] 1 [2.0] 1 [1.0] Tongue (48) (48) (48) (48) Artery, Inflammation, Chronic 2 [2.0] ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (48) (48) (48) (48) Infiltration Cellular, Lymphocyte 2 [1.0] Artery, Inflammation, Chronic 1 [2.0] 1 [3.0] ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (47) (47) (45) (47) Accessory Adrenal Cortical Nodule 1 [1.0] 1 [1.0] 1 [1.0] Hematopoietic Cell Proliferation 1 [1.0] Hyperplasia, Focal 1 [1.0] 1 [1.0] Hypertrophy, Focal 1 [2.0] 2 [2.5] Mineralization, Focal 1 [4.0] Vacuolization Cytoplasmic 1 [4.0] Bilateral, Hypertrophy, Focal 1 [3.0] Subcapsular, Hyperplasia 46 [1.9] 46 [2.0] 44 [1.9] 45 [2.0] Adrenal Medulla (47) (46) (44) (46) Hyperplasia, Focal 1 [1.0] 1 [1.0] Pituitary Gland (48) (47) (46) (45) Pars Distalis, Hyperplasia, Focal 1 [1.0] 2 [1.0] 5 [1.6] Pars Intermedia, Hyperplasia, Focal 1 [2.0] Thyroid Gland (47) (46) (46) (48) Hyperplasia, Focal 1 [1.0] Infiltration Cellular, Lymphocyte 1 [1.0] 1 [1.0] Ultimobranchial Cyst 2 [1.0] 2 [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 3 NTP Experiment-Test: 93005-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18 Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 06/19/03 Route: DOSED FEED MALACHITE GREEN Time: 07:29:07 ____________________________________________________________________________________________________________________________________ C57BL/6N XC3H/HEN MTN-NCTR FEMALE 0 PPM 100 PPM 225 PPM 450 PPM ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM - CONT Follicular Cell, Cyst 2 [1.0] 2 [1.0] 3 [1.0] 1 [1.0] ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM Tissue NOS (1) (1) Hemorrhage 1 [4.0] ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Clitoral Gland (48) (47) (46) (44) Inflammation, Chronic 1 [2.0] Duct, Cyst 44 [1.9] 47 [1.9] 45 [2.0] 44 [1.9] Ovary (48) (46) (46) (45) Angiectasis 1 [2.0] 1 [3.0] 1 [2.0] Atrophy 28 [2.1] 33 [2.3] 36 [2.5] 36 [2.6] Cyst 15 [1.0] 18 [1.0] 11 [1.0] 11 [1.0] Hemorrhage 3 [1.0] 1 [2.0] 1 [1.0] Inflammation, Acute 1 [3.0] Inflammation, Chronic Active 1 [3.0] Mineralization 1 [2.0] Thrombosis 1 [4.0] Bilateral, Cyst 4 [1.0] 3 [1.0] 3 [1.0] 2 [1.0] Germinal Epithelium, Hyperplasia 2 [2.0] Uterus (48) (48) (47) (48) Angiectasis 1 [2.0] 1 [2.0] Hyperplasia, Cystic 42 [2.3] 46 [2.5] 44 [2.4] 42 [2.2] Inflammation, Acute 1 [3.0] Thrombosis 1 [2.0] Vagina (48) (48) (46) (48) Inflammation, Chronic 1 [2.0] Artery, Inflammation, Chronic 1 [2.0] Epithelium, Hyperplasia 1 [1.0] ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (47) (47) (47) (48) Fibrosis 1 [1.0] Lymph Node (13) (13) (6) (9) Inguinal, Hyperplasia, Lymphoid 1 [2.0] Lumbar, Hyperplasia, Lymphoid 4 [2.0] 4 [2.0] 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 4 NTP Experiment-Test: 93005-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18 Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 06/19/03 Route: DOSED FEED MALACHITE GREEN Time: 07:29:07 ____________________________________________________________________________________________________________________________________ C57BL/6N XC3H/HEN MTN-NCTR FEMALE 0 PPM 100 PPM 225 PPM 450 PPM ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - CONT Mediastinal, Hemorrhage 2 [2.0] Mediastinal, Infiltration Cellular, Mononuclear Cell 1 [2.0] Pancreatic, Infiltration Cellular, Mononuclear Cell 1 [3.0] Renal, Hemorrhage 1 [3.0] Renal, Hyperplasia, Lymphoid 2 [2.0] 1 [2.0] 2 [2.0] 1 [2.0] Lymph Node, Mandibular (48) (48) (47) (48) Hemorrhage 1 [2.0] Hyperplasia, Lymphoid 2 [2.0] 1 [3.0] 2 [2.5] 1 [2.0] Infiltration Cellular, Mast Cell 1 [2.0] Lymph Node, Mesenteric (45) (46) (44) (46) Hemorrhage 1 [1.0] Hyperplasia, Lymphoid 8 [2.0] 8 [2.0] 5 [2.2] 5 [2.2] Spleen (47) (47) (45) (47) Angiectasis 1 [1.0] 1 [2.0] Depletion Cellular 1 [2.0] Hematopoietic Cell Proliferation 9 [2.4] 8 [2.5] 3 [2.0] 5 [3.0] Hyperplasia, Lymphoid 6 [2.2] 6 [2.3] 7 [2.1] 2 [1.5] Infiltration Cellular, Mononuclear Cell 1 [3.0] Necrosis, Focal 1 [3.0] Thymus (43) (44) (43) (47) Angiectasis 1 [2.0] Cyst 4 [1.0] 2 [1.0] 3 [1.0] 3 [1.0] Ectopic Parathyroid Gland 3 [1.0] 1 [1.0] 2 [1.0] 3 [1.0] Hyperplasia, Lymphoid 3 [1.3] 5 [2.2] 6 [2.3] 2 [2.5] Infiltration Cellular, Mononuclear Cell 1 [3.0] ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (46) (48) (45) (46) Infiltration Cellular, Lymphocyte 1 [2.0] Skin (48) (48) (46) (48) Fibrosis 1 [2.0] Hyperplasia 1 [3.0] ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (48) (48) (48) (48) Hyperostosis 1 [2.0] Cranium, Fibrous Osteodystrophy 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: 93005-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18 Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 06/19/03 Route: DOSED FEED MALACHITE GREEN Time: 07:29:07 ____________________________________________________________________________________________________________________________________ C57BL/6N XC3H/HEN MTN-NCTR FEMALE 0 PPM 100 PPM 225 PPM 450 PPM ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM - CONT Femur, Fibrous Osteodystrophy 4 [2.0] 5 [1.2] 2 [2.0] 2 [2.0] Sternum, Degeneration, Cystic 2 [1.0] 4 [1.3] 3 [1.0] Sternum, Fibrous Osteodystrophy 12 [1.8] 14 [1.5] 5 [1.4] 5 [1.0] ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (48) (48) (48) (48) Infiltration Cellular, Lymphocyte 1 [1.0] Cerebrum, Mineralization 25 [1.0] 18 [1.0] 17 [1.0] 17 [1.0] Spinal Cord (48) (48) (48) (48) Thoracic, Axon, Degeneration 13 [1.2] 14 [1.1] 19 [1.2] 19 [1.1] ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (48) (48) (48) (48) Hemorrhage, Focal 1 [2.0] Infiltration Cellular, Lymphocyte 6 [1.7] 6 [1.8] 6 [1.7] 2 [1.5] Infiltration Cellular, Histiocyte 2 [2.0] 3 [1.0] 2 [1.0] Inflammation, Chronic, Focal 1 [1.0] Pigmentation 1 [2.0] Proteinosis 3 [2.0] Thrombosis 1 [2.0] Alveolar Epithelium, Hyperplasia 1 [1.0] 3 [1.3] 1 [1.0] ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (48) (48) (47) (48) Bilateral, Lens, Cataract 4 [2.0] 2 [2.0] 5 [2.2] 2 [1.0] Cornea, Mineralization 1 [3.0] Lens, Cataract 1 [1.0] 2 [1.5] 1 [1.0] 6 [1.8] Harderian Gland (48) (48) (48) (48) Atrophy 1 [2.0] Hyperplasia 1 [2.0] 1 [2.0] Infiltration Cellular, Lymphocyte 4 [1.0] 5 [1.0] 5 [1.2] 4 [1.0] Zymbal's Gland (48) (48) (47) (47) Atrophy 1 [2.0] 1 [1.0] Inflammation, Chronic 1 [4.0] ____________________________________________________________________________________________________________________________________ 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 6 NTP Experiment-Test: 93005-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18 Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 06/19/03 Route: DOSED FEED MALACHITE GREEN Time: 07:29:07 ____________________________________________________________________________________________________________________________________ C57BL/6N XC3H/HEN MTN-NCTR FEMALE 0 PPM 100 PPM 225 PPM 450 PPM ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (48) (47) (48) (47) Infiltration Cellular, Lymphocyte 2 [1.5] 7 [1.4] 3 [1.0] 2 [1.5] Metaplasia, Focal 1 [1.0] Nephropathy 1 [1.0] 1 [1.0] Glomerulus, Amyloid Deposition 2 [4.0] Glomerulus, Casts Protein 1 [3.0] 1 [3.0] Glomerulus, Hypertrophy 1 [2.0] Glomerulus, Inflammation, Acute 1 [2.0] Pelvis, Dilatation 2 [2.5] Renal Tubule, Accumulation, Hyaline Droplet 4 [1.8] 1 [3.0] 1 [3.0] Renal Tubule, Hyperplasia 1 [1.0] Urinary Bladder (47) (46) (45) (48) Inclusion Body Intracytoplasmic 7 [1.1] 15 [1.1] 34 [1.4] 39 [1.4] Infiltration Cellular, Lymphocyte 36 [1.4] 34 [1.2] 33 [1.3] 25 [1.2] 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 ------------------------------------------------------------ ---------- END OF REPORT ---------- ------------------------------------------------------------