TDMS Study 93029-04 Pathology Tables
NTP Experiment-Test: 93029-04 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 LEUKOMALACHITE GREEN Time: 07:13:27 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: 93029-04 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 LEUKOMALACHITE GREEN Time: 07:13:27 ____________________________________________________________________________________________________________________________________ C57BL/6N XC3H/HEN MTN-NCTR FEMALE 0 PPM 91 PPM 204 PPM 408 PPM ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 48 48 48 48 Early Deaths Natural Death 7 2 2 5 Moribund 4 5 7 4 Survivors Terminal Sacrifice 37 41 39 39 Animals Examined Microscopically 47 48 47 47 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Gallbladder (44) (47) (44) (46) Infiltration Cellular, Lymphocytic 1 [2.0] Inflammation, Acute 1 [2.0] Polyarteritis 1 [1.0] Mucosa, Hyperplasia, Focal 2 [1.0] Intestine Large (46) (48) (47) (46) Cecum, Polyarteritis 1 [2.0] Colon, Angiectasis 1 [2.0] Colon, Proliferation Connective Tissue 1 [2.0] Rectum, Inflammation, Chronic 1 [3.0] 1 [2.0] Rectum, Polyarteritis 1 [2.0] Intestine Small (44) (47) (47) (46) Ileum, Hyperplasia, Lymphoid 1 [2.0] 1 [1.0] 3 [1.7] 1 [4.0] Jejunum, Hyperplasia, Lymphoid 2 [2.0] 1 [2.0] Liver (47) (48) (47) (47) Basophilic Focus 1 2 2 Basophilic Focus, Two 1 Clear Cell Focus 1 1 Eosinophilic Focus, Single 1 1 Hematopoietic Cell Proliferation 2 [1.5] 2 [3.0] 3 [2.3] 3 [2.0] Infarct 1 [4.0] Infiltration Cellular, Lymphocytic 8 [1.5] 2 [1.5] 2 [2.0] 8 [1.3] Inflammation, Chronic Active, Focal 15 [1.4] 13 [1.3] 16 [1.1] 11 [1.3] Leukocytosis 1 [2.0] Mineralization, Focal 1 [1.0] Necrosis 1 [2.0] Tension Lipidosis 10 [1.6] 12 [1.1] 9 [1.3] 9 [1.2] Vacuolization Cytoplasmic 2 [2.0] 1 [1.0] Bile Duct, Cyst 3 [2.3] 1 [2.0] 1 [2.0] 1 [2.0] Oval Cell, Hyperplasia 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 2 NTP Experiment-Test: 93029-04 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 LEUKOMALACHITE GREEN Time: 07:13:27 ____________________________________________________________________________________________________________________________________ C57BL/6N XC3H/HEN MTN-NCTR FEMALE 0 PPM 91 PPM 204 PPM 408 PPM ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Serosa, Fibrosis 1 [2.0] Mesentery (1) (2) (1) (3) Fat, Necrosis, Focal 1 [2.0] 2 [2.0] 1 [1.0] 3 [2.0] Pancreas (45) (48) (47) (45) Cyst 2 [2.0] Cytoplasmic Alteration 1 [1.0] 1 [1.0] 1 [1.0] 2 [1.5] Infiltration Cellular, Lymphocytic 7 [1.4] 9 [1.1] 4 [1.0] 6 [1.2] Polyarteritis 1 [3.0] Acinus, Atrophy 1 [1.0] 2 [2.0] 1 [1.0] 2 [3.0] Salivary Glands (47) (48) (47) (47) Acinus, Parotid Gland, Atrophy 1 [1.0] 3 [2.7] 1 [3.0] Acinus, Parotid Gland, Necrosis, Focal 3 [1.3] 2 [1.0] Acinus, Submandibular Gland, Atrophy 1 [2.0] 1 [3.0] 1 [3.0] Parotid Gland, Infiltration Cellular, Lymphocytic 9 [1.2] 9 [1.1] 8 [1.5] 11 [1.4] Parotid Gland, Vacuolization Cytoplasmic 2 [2.0] 1 [2.0] Sublingual Gland, Infiltration Cellular, Lymphocytic 2 [1.0] 1 [1.0] Submandibular Gland, Infiltration Cellular, Lymphocytic 33 [1.6] 30 [1.5] 35 [1.6] 31 [1.5] Stomach (46) (48) (47) (46) Forestomach, Foreign Body 1 [2.0] Forestomach, Hyperkeratosis, Focal 1 [1.0] Forestomach, Infiltration Cellular, Lymphocytic 1 [2.0] Forestomach, Inflammation, Chronic Active 2 [2.0] Forestomach, Epithelium, Hyperplasia, Diffuse 1 [3.0] Forestomach, Epithelium, Hyperplasia, Focal 3 [2.0] 4 [1.5] 8 [2.3] 6 [1.5] Glandular, Infiltration Cellular, Lymphocytic 1 [2.0] 2 [2.0] 1 [1.0] Glandular, Polyarteritis 1 [2.0] Glandular, Ulcer 1 [2.0] Tongue (47) (48) (47) (47) Foreign Body 3 [1.0] 1 [1.0] 3 [1.0] Artery, Inflammation, Chronic 1 [2.0] 2 [2.0] 2 [2.0] ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Blood Vessel (47) (48) (46) (46) Aorta, Embolus Bacterial 1 [4.0] Heart (47) (48) (47) (47) Cardiomyopathy 1 [1.0] Inflammation, Acute, Focal 1 [2.0] 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 3 NTP Experiment-Test: 93029-04 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 LEUKOMALACHITE GREEN Time: 07:13:27 ____________________________________________________________________________________________________________________________________ C57BL/6N XC3H/HEN MTN-NCTR FEMALE 0 PPM 91 PPM 204 PPM 408 PPM ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM - CONT Mineralization 1 [1.0] Polyarteritis 1 [3.0] Atrium Left, Thrombosis 1 [3.0] ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Gland (46) (48) (47) (47) Bilateral, Cortex, Hypertrophy, Focal 1 [2.0] Cortex, Accessory Adrenal Cortical Nodule 3 1 1 1 Cortex, Cyst 1 Cortex, Hematopoietic Cell Proliferation 1 [1.0] 1 [3.0] Cortex, Hyperplasia, Focal 2 [1.0] 2 [2.0] Cortex, Hypertrophy, Focal 2 [1.5] 2 [2.0] 1 [3.0] Cortex, Polyarteritis 1 [3.0] Cortex, Subcapsular, Hyperplasia 42 [1.9] 47 [1.9] 46 [1.8] 47 [1.9] Medulla, Hyperplasia, Focal 1 [1.0] Parathyroid Gland (42) (42) (41) (44) Infiltration Cellular, Lymphocytic 1 [3.0] Pituitary Gland (41) (45) (44) (46) Pars Distalis, Hyperplasia, Focal 3 [1.3] 1 [1.0] 3 [1.3] 2 [2.5] Thyroid Gland (46) (48) (47) (47) Ectopic Thymus 1 Polyarteritis 1 [3.0] Ultimobranchial Cyst 2 2 Follicular Cell, Cyst 7 [1.7] 10 [1.5] 6 [1.0] 9 [1.3] ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Clitoral Gland (45) (46) (44) (45) Inflammation, Chronic 1 [2.0] Inflammation, Subacute 1 [2.0] Duct, Cyst 44 [1.9] 46 [1.9] 41 [1.9] 45 [1.8] Ovary (46) (48) (47) (44) Abscess 1 Angiectasis 1 [2.0] 1 [2.0] 2 [2.0] Atrophy 42 [1.9] 45 [1.7] 44 [1.9] 41 [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: 93029-04 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 LEUKOMALACHITE GREEN Time: 07:13:27 ____________________________________________________________________________________________________________________________________ C57BL/6N XC3H/HEN MTN-NCTR FEMALE 0 PPM 91 PPM 204 PPM 408 PPM ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM - CONT Cyst 14 16 17 10 Hemorrhage 4 [1.8] 2 [2.0] 2 [1.0] 2 [1.0] Mineralization 1 [1.0] Thrombosis 3 [3.0] Bilateral, Cyst 7 3 2 3 Uterus (46) (48) (47) (46) Adenomyosis, Focal 1 [3.0] Angiectasis 4 [1.8] 3 [1.3] 1 [1.0] Hyperplasia, Cystic 42 [2.4] 46 [2.6] 47 [2.4] 43 [2.5] Inflammation, Acute 1 [3.0] Polyarteritis 1 [2.0] Thrombosis 1 [4.0] 3 [2.3] Endometrium, Metaplasia 1 [2.0] Stroma, Fibrosis 1 [3.0] Stroma, Hyperplasia 1 [3.0] Vagina (45) (47) (47) (46) Epithelium, Hyperplasia 1 [2.0] 3 [1.7] ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (46) (48) (47) (46) Angiectasis, Focal 1 [2.0] Fibrosis 1 [3.0] 1 [3.0] Femoral, Infarct 1 [2.0] Myeloid Cell, Hyperplasia 4 [2.3] 1 [2.0] 4 [3.0] 6 [2.2] Lymph Node (47) (48) (47) (47) Inguinal, Hyperplasia, Lymphoid 1 [1.0] Lumbar, Cyst 1 Lumbar, Hematopoietic Cell Proliferation 1 [3.0] Lumbar, Hyperplasia, Lymphoid 1 [3.0] Lumbar, Hyperplasia, Plasma Cell 1 [3.0] Mandibular, Hyperplasia, Lymphoid 1 [2.0] 3 [2.7] 8 [2.6] 2 [2.0] Mediastinal, Hyperplasia, Lymphoid 1 [2.0] Mesenteric, Hematopoietic Cell Proliferation 1 [2.0] 1 [2.0] Mesenteric, Hemorrhage 1 [1.0] 1 [2.0] 1 [2.0] 1 [1.0] Mesenteric, Hyperplasia, Lymphoid 5 [2.2] 2 [2.0] 3 [2.7] 6 [2.7] Mesenteric, Infiltration Cellular, Plasma Cell 2 [3.0] 1 [4.0] Renal, Hyperplasia, Lymphoid 2 [2.5] Thoracic, Hyperplasia, Plasma Cell 1 [3.0] Spleen (45) (48) (47) (45) Angiectasis 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: 93029-04 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 LEUKOMALACHITE GREEN Time: 07:13:27 ____________________________________________________________________________________________________________________________________ C57BL/6N XC3H/HEN MTN-NCTR FEMALE 0 PPM 91 PPM 204 PPM 408 PPM ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - CONT Hematopoietic Cell Proliferation 11 [2.5] 9 [2.6] 17 [2.1] 17 [2.2] Hyperplasia, Lymphoid 14 [2.1] 4 [1.8] 8 [2.1] 9 [2.1] Infiltration Cellular, Plasma Cell 1 [4.0] 1 [4.0] Proliferation Connective Tissue, Focal 1 [1.0] Thymus (43) (45) (45) (43) Atrophy 2 [2.0] 2 [2.5] 1 [2.0] Cyst 2 1 2 2 Ectopic Parathyroid Gland 4 7 4 7 Hyperplasia, Lymphoid 2 [1.5] 3 [1.3] 5 [2.0] 6 [1.8] ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (46) (48) (47) (45) Infiltration Cellular, Lymphocytic 1 [2.0] Skin (46) (48) (45) (45) Face, Ulcer 1 [3.0] ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (47) (48) (47) (47) Femur, Fibrous Osteodystrophy 8 [1.4] 2 [1.0] 5 [1.6] 3 [1.0] Sternum, Degeneration, Cystic 1 [1.0] 3 [1.0] 1 [1.0] 5 [1.0] Sternum, Fibrous Osteodystrophy 26 [1.4] 21 [1.4] 19 [1.4] 21 [1.2] Skeletal Muscle (47) (48) (47) (46) Mineralization 2 [2.0] ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (47) (48) (47) (47) Cerebellum, Infiltration Cellular, Lymphocytic 1 [2.0] Cerebrum, Mineralization 15 [1.0] 18 [1.0] 21 [1.0] 21 [1.0] Cerebrum, Polyarteritis 1 [1.0] Spinal Cord (47) (48) (47) (47) Thoracic, Infiltration Cellular, Lymphocytic 1 [1.0] Thoracic, Axon, Degeneration 12 [1.0] 11 [1.2] 9 [1.0] 14 [1.2] ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM 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: 93029-04 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 LEUKOMALACHITE GREEN Time: 07:13:27 ____________________________________________________________________________________________________________________________________ C57BL/6N XC3H/HEN MTN-NCTR FEMALE 0 PPM 91 PPM 204 PPM 408 PPM ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM - CONT Lung (47) (48) (47) (47) Crystals 1 [2.0] 1 [3.0] Hemorrhage, Focal 1 [2.0] Infarct 1 [2.0] Infiltration Cellular, Histiocytic 1 [1.0] 2 [1.0] 2 [1.0] Infiltration Cellular, Lymphocytic 13 [1.8] 7 [1.7] 9 [1.8] 12 [1.5] Inflammation, Chronic, Focal 1 [1.0] 1 [1.0] 1 [1.0] Inflammation, Granulomatous 1 [2.0] Leukocytosis 2 [2.0] 1 [4.0] Alveolar Epithelium, Hyperplasia 1 [1.0] 1 [1.0] 1 [1.0] 1 [1.0] Artery, Mineralization 1 [1.0] Vein, Thrombosis 1 [3.0] ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (47) (48) (47) (47) Phthisis Bulbi 1 Bilateral, Lens, Cataract 4 [3.3] 5 [2.0] 3 [2.3] 7 [2.4] Conjunctiva, Polyarteritis 1 [2.0] Cornea, Inflammation, Chronic 1 [2.0] Lens, Cataract 5 [1.8] 4 [1.8] 4 [2.0] 4 [1.8] Harderian Gland (47) (48) (47) (47) Atrophy 1 [1.0] Hyperplasia 1 [2.0] 1 [2.0] 3 [1.7] Infiltration Cellular, Lymphocytic 4 [1.3] 9 [1.6] 8 [1.1] 5 [1.0] Acinus, Dilatation 1 [2.0] Zymbal's Gland (47) (47) (46) (47) Atrophy 1 [2.0] 1 [2.0] ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (47) (48) (47) (47) Glomerulosclerosis 1 [1.0] 1 [1.0] Hematopoietic Cell Proliferation 1 [2.0] Infarct 2 [1.0] 1 [1.0] 1 [1.0] Infiltration Cellular, Lymphocytic 9 [1.4] 5 [1.0] 15 [1.1] 11 [1.3] Nephropathy 1 [3.0] 2 [1.0] 3 [1.0] 1 [1.0] Polyarteritis 1 [3.0] Glomerulus, Casts Protein 1 [2.0] 1 [3.0] Papilla, Casts Protein 1 [1.0] Pelvis, Dilatation 2 [3.5] 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 7 NTP Experiment-Test: 93029-04 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 LEUKOMALACHITE GREEN Time: 07:13:27 ____________________________________________________________________________________________________________________________________ C57BL/6N XC3H/HEN MTN-NCTR FEMALE 0 PPM 91 PPM 204 PPM 408 PPM ____________________________________________________________________________________________________________________________________ URINARY SYSTEM - CONT Renal Tubule, Accumulation, Hyaline Droplet 1 [3.0] 2 [2.5] 1 [2.0] 3 [2.3] Renal Tubule, Hyperplasia 1 [2.0] Renal Tubule, Hypertrophy 1 [1.0] Renal Tubule, Necrosis 1 [2.0] Renal Tubule, Pigmentation 1 [2.0] Urinary Bladder (46) (48) (47) (44) Inclusion Body Intracytoplasmic 14 [1.0] 33 [1.2] 44 [1.9] 44 [2.9] Infiltration Cellular, Lymphocytic 29 [1.4] 22 [1.1] 24 [1.2] 26 [1.3] Polyarteritis 1 [1.0] Submucosa, Edema 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 8 ------------------------------------------------------------ ---------- END OF REPORT ---------- ------------------------------------------------------------