TDMS Study 93005-04 Pathology Tables
NTP Experiment-Test: 93005-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC MALACHITE GREEN Date: 06/19/03 Route: DOSED FEED Time: 07:15:44 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 Page 1 NTP Experiment-Test: 93005-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC MALACHITE GREEN Date: 06/19/03 Route: DOSED FEED Time: 07:15:44 ____________________________________________________________________________________________________________________________________ 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%) Intestine Small, Jejunum (46) (47) (44) (47) Hyperplasia, Lymphoid 1 (2%) Liver (48) (48) (46) (48) Basophilic Focus 1 (2%) 1 (2%) 3 (7%) Fatty Change, Focal 1 (2%) Hematopoietic Cell Proliferation 2 (4%) 1 (2%) 2 (4%) Infiltration Cellular, Lymphocyte 4 (8%) 6 (13%) 8 (17%) 12 (25%) Infiltration Cellular, Histiocyte 1 (2%) Inflammation, Chronic Active, Focal 5 (10%) 9 (19%) 8 (17%) 4 (8%) Necrosis 2 (4%) Tension Lipidosis 10 (21%) 7 (15%) 8 (17%) 6 (13%) Bile Duct, Cyst 1 (2%) Mesentery (2) (5) (1) Infiltration Cellular, Lymphocyte 1 (20%) Fat, Necrosis, Focal 2 (100%) 3 (60%) 1 (100%) Pancreas (47) (47) (44) (47) Cyst 1 (2%) Cytoplasmic Alteration 1 (2%) 1 (2%) 1 (2%) Infiltration Cellular, Lymphocyte 6 (13%) 4 (9%) 2 (5%) 3 (6%) Necrosis, Focal 1 (2%) Acinus, Atrophy 2 (4%) Salivary Glands (48) (48) (48) (48) Infiltration Cellular, Mononuclear Cell 1 (2%) Parotid Gland, Infiltration Cellular, Lymphocyte 5 (10%) 12 (25%) 4 (8%) 5 (10%) Sublingual Gland, Infiltration Cellular, Lymphocyte 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 2 NTP Experiment-Test: 93005-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC MALACHITE GREEN Date: 06/19/03 Route: DOSED FEED Time: 07:15:44 ____________________________________________________________________________________________________________________________________ C57BL/6N XC3H/HEN MTN-NCTR FEMALE 0 PPM 100 PPM 225 PPM 450 PPM ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Submandibular Gland, Infiltration Cellular, Lymphocyte 35 (73%) 28 (58%) 28 (58%) 28 (58%) Stomach, Forestomach (47) (47) (46) (48) Hyperkeratosis, Focal 1 (2%) Infiltration Cellular, Mast Cell 1 (2%) Inflammation, Chronic Active 2 (4%) 3 (6%) 2 (4%) 1 (2%) Ulcer 1 (2%) Epithelium, Hyperplasia, Diffuse 2 (4%) 2 (4%) 1 (2%) Epithelium, Hyperplasia, Focal 11 (23%) 8 (17%) 4 (9%) 7 (15%) Stomach, Glandular (47) (47) (46) (48) Erosion 1 (2%) 1 (2%) Ulcer 1 (2%) 1 (2%) 1 (2%) Tongue (48) (48) (48) (48) Artery, Inflammation, Chronic 2 (4%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (48) (48) (48) (48) Infiltration Cellular, Lymphocyte 2 (4%) Artery, Inflammation, Chronic 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (47) (47) (45) (47) Accessory Adrenal Cortical Nodule 1 (2%) 1 (2%) 1 (2%) Hematopoietic Cell Proliferation 1 (2%) Hyperplasia, Focal 1 (2%) 1 (2%) Hypertrophy, Focal 1 (2%) 2 (4%) Mineralization, Focal 1 (2%) Vacuolization Cytoplasmic 1 (2%) Bilateral, Hypertrophy, Focal 1 (2%) Subcapsular, Hyperplasia 46 (98%) 46 (98%) 44 (98%) 45 (96%) Adrenal Medulla (47) (46) (44) (46) Hyperplasia, Focal 1 (2%) 1 (2%) Pituitary Gland (48) (47) (46) (45) Pars Distalis, Hyperplasia, Focal 1 (2%) 2 (4%) 5 (11%) Pars Intermedia, Hyperplasia, Focal 1 (2%) Thyroid Gland (47) (46) (46) (48) Hyperplasia, Focal 1 (2%) Infiltration Cellular, Lymphocyte 1 (2%) 1 (2%) Ultimobranchial Cyst 2 (4%) 2 (4%) a Number of animals examined microscopically at site and number of animals with lesion Page 3 NTP Experiment-Test: 93005-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC MALACHITE GREEN Date: 06/19/03 Route: DOSED FEED Time: 07:15:44 ____________________________________________________________________________________________________________________________________ C57BL/6N XC3H/HEN MTN-NCTR FEMALE 0 PPM 100 PPM 225 PPM 450 PPM ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM - CONT Follicular Cell, Cyst 2 (4%) 2 (4%) 3 (7%) 1 (2%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM Tissue NOS (1) (1) Hemorrhage 1 (100%) ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Clitoral Gland (48) (47) (46) (44) Inflammation, Chronic 1 (2%) Duct, Cyst 44 (92%) 47 (100%) 45 (98%) 44 (100%) Ovary (48) (46) (46) (45) Angiectasis 1 (2%) 1 (2%) 1 (2%) Atrophy 28 (58%) 33 (72%) 36 (78%) 36 (80%) Cyst 15 (31%) 18 (39%) 11 (24%) 11 (24%) Hemorrhage 3 (6%) 1 (2%) 1 (2%) Inflammation, Acute 1 (2%) Inflammation, Chronic Active 1 (2%) Mineralization 1 (2%) Thrombosis 1 (2%) Bilateral, Cyst 4 (8%) 3 (7%) 3 (7%) 2 (4%) Germinal Epithelium, Hyperplasia 2 (4%) Uterus (48) (48) (47) (48) Angiectasis 1 (2%) 1 (2%) Hyperplasia, Cystic 42 (88%) 46 (96%) 44 (94%) 42 (88%) Inflammation, Acute 1 (2%) Thrombosis 1 (2%) Vagina (48) (48) (46) (48) Inflammation, Chronic 1 (2%) Artery, Inflammation, Chronic 1 (2%) Epithelium, Hyperplasia 1 (2%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (47) (47) (47) (48) Fibrosis 1 (2%) Lymph Node (13) (13) (6) (9) Inguinal, Hyperplasia, Lymphoid 1 (17%) Lumbar, Hyperplasia, Lymphoid 4 (31%) 4 (31%) 2 (33%) 1 (11%) a Number of animals examined microscopically at site and number of animals with lesion Page 4 NTP Experiment-Test: 93005-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC MALACHITE GREEN Date: 06/19/03 Route: DOSED FEED Time: 07:15:44 ____________________________________________________________________________________________________________________________________ C57BL/6N XC3H/HEN MTN-NCTR FEMALE 0 PPM 100 PPM 225 PPM 450 PPM ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - CONT Mediastinal, Hemorrhage 2 (15%) Mediastinal, Infiltration Cellular, Mononuclear Cell 1 (8%) Pancreatic, Infiltration Cellular, Mononuclear Cell 1 (8%) Renal, Hemorrhage 1 (8%) Renal, Hyperplasia, Lymphoid 2 (15%) 1 (8%) 2 (33%) 1 (11%) Lymph Node, Mandibular (48) (48) (47) (48) Hemorrhage 1 (2%) Hyperplasia, Lymphoid 2 (4%) 1 (2%) 2 (4%) 1 (2%) Infiltration Cellular, Mast Cell 1 (2%) Lymph Node, Mesenteric (45) (46) (44) (46) Hemorrhage 1 (2%) Hyperplasia, Lymphoid 8 (18%) 8 (17%) 5 (11%) 5 (11%) Spleen (47) (47) (45) (47) Angiectasis 1 (2%) 1 (2%) Depletion Cellular 1 (2%) Hematopoietic Cell Proliferation 9 (19%) 8 (17%) 3 (7%) 5 (11%) Hyperplasia, Lymphoid 6 (13%) 6 (13%) 7 (16%) 2 (4%) Infiltration Cellular, Mononuclear Cell 1 (2%) Necrosis, Focal 1 (2%) Thymus (43) (44) (43) (47) Angiectasis 1 (2%) Cyst 4 (9%) 2 (5%) 3 (7%) 3 (6%) Ectopic Parathyroid Gland 3 (7%) 1 (2%) 2 (5%) 3 (6%) Hyperplasia, Lymphoid 3 (7%) 5 (11%) 6 (14%) 2 (4%) Infiltration Cellular, Mononuclear Cell 1 (2%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (46) (48) (45) (46) Infiltration Cellular, Lymphocyte 1 (2%) Skin (48) (48) (46) (48) Fibrosis 1 (2%) Hyperplasia 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (48) (48) (48) (48) Hyperostosis 1 (2%) Cranium, Fibrous Osteodystrophy 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 5 NTP Experiment-Test: 93005-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC MALACHITE GREEN Date: 06/19/03 Route: DOSED FEED Time: 07:15:44 ____________________________________________________________________________________________________________________________________ C57BL/6N XC3H/HEN MTN-NCTR FEMALE 0 PPM 100 PPM 225 PPM 450 PPM ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM - CONT Femur, Fibrous Osteodystrophy 4 (8%) 5 (10%) 2 (4%) 2 (4%) Sternum, Degeneration, Cystic 2 (4%) 4 (8%) 3 (6%) Sternum, Fibrous Osteodystrophy 12 (25%) 14 (29%) 5 (10%) 5 (10%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (48) (48) (48) (48) Infiltration Cellular, Lymphocyte 1 (2%) Cerebrum, Mineralization 25 (52%) 18 (38%) 17 (35%) 17 (35%) Spinal Cord (48) (48) (48) (48) Thoracic, Axon, Degeneration 13 (27%) 14 (29%) 19 (40%) 19 (40%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (48) (48) (48) (48) Hemorrhage, Focal 1 (2%) Infiltration Cellular, Lymphocyte 6 (13%) 6 (13%) 6 (13%) 2 (4%) Infiltration Cellular, Histiocyte 2 (4%) 3 (6%) 2 (4%) Inflammation, Chronic, Focal 1 (2%) Pigmentation 1 (2%) Proteinosis 3 (6%) Thrombosis 1 (2%) Alveolar Epithelium, Hyperplasia 1 (2%) 3 (6%) 1 (2%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (48) (48) (47) (48) Bilateral, Lens, Cataract 4 (8%) 2 (4%) 5 (11%) 2 (4%) Cornea, Mineralization 1 (2%) Lens, Cataract 1 (2%) 2 (4%) 1 (2%) 6 (13%) Harderian Gland (48) (48) (48) (48) Atrophy 1 (2%) Hyperplasia 1 (2%) 1 (2%) Infiltration Cellular, Lymphocyte 4 (8%) 5 (10%) 5 (10%) 4 (8%) Zymbal's Gland (48) (48) (47) (47) Atrophy 1 (2%) 1 (2%) Inflammation, Chronic 1 (2%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 6 NTP Experiment-Test: 93005-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC MALACHITE GREEN Date: 06/19/03 Route: DOSED FEED Time: 07:15:44 ____________________________________________________________________________________________________________________________________ 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 (4%) 7 (15%) 3 (6%) 2 (4%) Metaplasia, Focal 1 (2%) Nephropathy 1 (2%) 1 (2%) Glomerulus, Amyloid Deposition 2 (4%) Glomerulus, Casts Protein 1 (2%) 1 (2%) Glomerulus, Hypertrophy 1 (2%) Glomerulus, Inflammation, Acute 1 (2%) Pelvis, Dilatation 2 (4%) Renal Tubule, Accumulation, Hyaline Droplet 4 (8%) 1 (2%) 1 (2%) Renal Tubule, Hyperplasia 1 (2%) Urinary Bladder (47) (46) (45) (48) Inclusion Body Intracytoplasmic 7 (15%) 15 (33%) 34 (76%) 39 (81%) Infiltration Cellular, Lymphocyte 36 (77%) 34 (74%) 33 (73%) 25 (52%) a Number of animals examined microscopically at site and number of animals with lesion Page 7 ------------------------------------------------------------ ---------- END OF REPORT ---------- ------------------------------------------------------------