TDMS Study 93029-04 Pathology Tables
NTP Experiment-Test: 93029-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC LEUKOMALACHITE GREEN Date: 06/19/03 Route: DOSED FEED Time: 07:04:42 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: 93029-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC LEUKOMALACHITE GREEN Date: 06/19/03 Route: DOSED FEED Time: 07:04:42 ____________________________________________________________________________________________________________________________________ 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%) Inflammation, Acute 1 (2%) Polyarteritis 1 (2%) Mucosa, Hyperplasia, Focal 2 (4%) Intestine Large (46) (48) (47) (46) Cecum, Polyarteritis 1 (2%) Colon, Angiectasis 1 (2%) Colon, Proliferation Connective Tissue 1 (2%) Rectum, Inflammation, Chronic 1 (2%) 1 (2%) Rectum, Polyarteritis 1 (2%) Intestine Small (44) (47) (47) (46) Ileum, Hyperplasia, Lymphoid 1 (2%) 1 (2%) 3 (6%) 1 (2%) Jejunum, Hyperplasia, Lymphoid 2 (4%) 1 (2%) Liver (47) (48) (47) (47) Basophilic Focus 1 (2%) 2 (4%) 2 (4%) Basophilic Focus, Two 1 (2%) Clear Cell Focus 1 (2%) 1 (2%) Eosinophilic Focus, Single 1 (2%) 1 (2%) Hematopoietic Cell Proliferation 2 (4%) 2 (4%) 3 (6%) 3 (6%) Infarct 1 (2%) Infiltration Cellular, Lymphocytic 8 (17%) 2 (4%) 2 (4%) 8 (17%) Inflammation, Chronic Active, Focal 15 (32%) 13 (27%) 16 (34%) 11 (23%) Leukocytosis 1 (2%) Mineralization, Focal 1 (2%) Necrosis 1 (2%) Tension Lipidosis 10 (21%) 12 (25%) 9 (19%) 9 (19%) Vacuolization Cytoplasmic 2 (4%) 1 (2%) Bile Duct, Cyst 3 (6%) 1 (2%) 1 (2%) 1 (2%) Oval Cell, Hyperplasia 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 2 NTP Experiment-Test: 93029-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC LEUKOMALACHITE GREEN Date: 06/19/03 Route: DOSED FEED Time: 07:04:42 ____________________________________________________________________________________________________________________________________ C57BL/6N XC3H/HEN MTN-NCTR FEMALE 0 PPM 91 PPM 204 PPM 408 PPM ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Serosa, Fibrosis 1 (2%) Mesentery (1) (2) (1) (3) Fat, Necrosis, Focal 1 (100%) 2 (100%) 1 (100%) 3 (100%) Pancreas (45) (48) (47) (45) Cyst 2 (4%) Cytoplasmic Alteration 1 (2%) 1 (2%) 1 (2%) 2 (4%) Infiltration Cellular, Lymphocytic 7 (16%) 9 (19%) 4 (9%) 6 (13%) Polyarteritis 1 (2%) Acinus, Atrophy 1 (2%) 2 (4%) 1 (2%) 2 (4%) Salivary Glands (47) (48) (47) (47) Acinus, Parotid Gland, Atrophy 1 (2%) 3 (6%) 1 (2%) Acinus, Parotid Gland, Necrosis, Focal 3 (6%) 2 (4%) Acinus, Submandibular Gland, Atrophy 1 (2%) 1 (2%) 1 (2%) Parotid Gland, Infiltration Cellular, Lymphocytic 9 (19%) 9 (19%) 8 (17%) 11 (23%) Parotid Gland, Vacuolization Cytoplasmic 2 (4%) 1 (2%) Sublingual Gland, Infiltration Cellular, Lymphocytic 2 (4%) 1 (2%) Submandibular Gland, Infiltration Cellular, Lymphocytic 33 (70%) 30 (63%) 35 (74%) 31 (66%) Stomach (46) (48) (47) (46) Forestomach, Foreign Body 1 (2%) Forestomach, Hyperkeratosis, Focal 1 (2%) Forestomach, Infiltration Cellular, Lymphocytic 1 (2%) Forestomach, Inflammation, Chronic Active 2 (4%) Forestomach, Epithelium, Hyperplasia, Diffuse 1 (2%) Forestomach, Epithelium, Hyperplasia, Focal 3 (7%) 4 (8%) 8 (17%) 6 (13%) Glandular, Infiltration Cellular, Lymphocytic 1 (2%) 2 (4%) 1 (2%) Glandular, Polyarteritis 1 (2%) Glandular, Ulcer 1 (2%) Tongue (47) (48) (47) (47) Foreign Body 3 (6%) 1 (2%) 3 (6%) Artery, Inflammation, Chronic 1 (2%) 2 (4%) 2 (4%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Blood Vessel (47) (48) (46) (46) Aorta, Embolus Bacterial 1 (2%) Heart (47) (48) (47) (47) Cardiomyopathy 1 (2%) Inflammation, Acute, Focal 1 (2%) 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 3 NTP Experiment-Test: 93029-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC LEUKOMALACHITE GREEN Date: 06/19/03 Route: DOSED FEED Time: 07:04:42 ____________________________________________________________________________________________________________________________________ C57BL/6N XC3H/HEN MTN-NCTR FEMALE 0 PPM 91 PPM 204 PPM 408 PPM ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM - CONT Mineralization 1 (2%) Polyarteritis 1 (2%) Atrium Left, Thrombosis 1 (2%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Gland (46) (48) (47) (47) Bilateral, Cortex, Hypertrophy, Focal 1 (2%) Cortex, Accessory Adrenal Cortical Nodule 3 (7%) 1 (2%) 1 (2%) 1 (2%) Cortex, Cyst 1 (2%) Cortex, Hematopoietic Cell Proliferation 1 (2%) 1 (2%) Cortex, Hyperplasia, Focal 2 (4%) 2 (4%) Cortex, Hypertrophy, Focal 2 (4%) 2 (4%) 1 (2%) Cortex, Polyarteritis 1 (2%) Cortex, Subcapsular, Hyperplasia 42 (91%) 47 (98%) 46 (98%) 47 (100%) Medulla, Hyperplasia, Focal 1 (2%) Parathyroid Gland (42) (42) (41) (44) Infiltration Cellular, Lymphocytic 1 (2%) Pituitary Gland (41) (45) (44) (46) Pars Distalis, Hyperplasia, Focal 3 (7%) 1 (2%) 3 (7%) 2 (4%) Thyroid Gland (46) (48) (47) (47) Ectopic Thymus 1 (2%) Polyarteritis 1 (2%) Ultimobranchial Cyst 2 (4%) 2 (4%) Follicular Cell, Cyst 7 (15%) 10 (21%) 6 (13%) 9 (19%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Clitoral Gland (45) (46) (44) (45) Inflammation, Chronic 1 (2%) Inflammation, Subacute 1 (2%) Duct, Cyst 44 (98%) 46 (100%) 41 (93%) 45 (100%) Ovary (46) (48) (47) (44) Abscess 1 (2%) Angiectasis 1 (2%) 1 (2%) 2 (4%) Atrophy 42 (91%) 45 (94%) 44 (94%) 41 (93%) a Number of animals examined microscopically at site and number of animals with lesion Page 4 NTP Experiment-Test: 93029-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC LEUKOMALACHITE GREEN Date: 06/19/03 Route: DOSED FEED Time: 07:04:42 ____________________________________________________________________________________________________________________________________ C57BL/6N XC3H/HEN MTN-NCTR FEMALE 0 PPM 91 PPM 204 PPM 408 PPM ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM - CONT Cyst 14 (30%) 16 (33%) 17 (36%) 10 (23%) Hemorrhage 4 (9%) 2 (4%) 2 (4%) 2 (5%) Mineralization 1 (2%) Thrombosis 3 (7%) Bilateral, Cyst 7 (15%) 3 (6%) 2 (4%) 3 (7%) Uterus (46) (48) (47) (46) Adenomyosis, Focal 1 (2%) Angiectasis 4 (8%) 3 (6%) 1 (2%) Hyperplasia, Cystic 42 (91%) 46 (96%) 47 (100%) 43 (93%) Inflammation, Acute 1 (2%) Polyarteritis 1 (2%) Thrombosis 1 (2%) 3 (6%) Endometrium, Metaplasia 1 (2%) Stroma, Fibrosis 1 (2%) Stroma, Hyperplasia 1 (2%) Vagina (45) (47) (47) (46) Epithelium, Hyperplasia 1 (2%) 3 (7%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (46) (48) (47) (46) Angiectasis, Focal 1 (2%) Fibrosis 1 (2%) 1 (2%) Femoral, Infarct 1 (2%) Myeloid Cell, Hyperplasia 4 (9%) 1 (2%) 4 (9%) 6 (13%) Lymph Node (47) (48) (47) (47) Inguinal, Hyperplasia, Lymphoid 1 (2%) Lumbar, Cyst 1 (2%) Lumbar, Hematopoietic Cell Proliferation 1 (2%) Lumbar, Hyperplasia, Lymphoid 1 (2%) Lumbar, Hyperplasia, Plasma Cell 1 (2%) Mandibular, Hyperplasia, Lymphoid 1 (2%) 3 (6%) 8 (17%) 2 (4%) Mediastinal, Hyperplasia, Lymphoid 1 (2%) Mesenteric, Hematopoietic Cell Proliferation 1 (2%) 1 (2%) Mesenteric, Hemorrhage 1 (2%) 1 (2%) 1 (2%) 1 (2%) Mesenteric, Hyperplasia, Lymphoid 5 (11%) 2 (4%) 3 (6%) 6 (13%) Mesenteric, Infiltration Cellular, Plasma Cell 2 (4%) 1 (2%) Renal, Hyperplasia, Lymphoid 2 (4%) Thoracic, Hyperplasia, Plasma Cell 1 (2%) Spleen (45) (48) (47) (45) Angiectasis 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 5 NTP Experiment-Test: 93029-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC LEUKOMALACHITE GREEN Date: 06/19/03 Route: DOSED FEED Time: 07:04:42 ____________________________________________________________________________________________________________________________________ C57BL/6N XC3H/HEN MTN-NCTR FEMALE 0 PPM 91 PPM 204 PPM 408 PPM ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - CONT Hematopoietic Cell Proliferation 11 (24%) 9 (19%) 17 (36%) 17 (38%) Hyperplasia, Lymphoid 14 (31%) 4 (8%) 8 (17%) 9 (20%) Infiltration Cellular, Plasma Cell 1 (2%) 1 (2%) Proliferation Connective Tissue, Focal 1 (2%) Thymus (43) (45) (45) (43) Atrophy 2 (5%) 2 (4%) 1 (2%) Cyst 2 (5%) 1 (2%) 2 (4%) 2 (5%) Ectopic Parathyroid Gland 4 (9%) 7 (16%) 4 (9%) 7 (16%) Hyperplasia, Lymphoid 2 (5%) 3 (7%) 5 (11%) 6 (14%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (46) (48) (47) (45) Infiltration Cellular, Lymphocytic 1 (2%) Skin (46) (48) (45) (45) Face, Ulcer 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (47) (48) (47) (47) Femur, Fibrous Osteodystrophy 8 (17%) 2 (4%) 5 (11%) 3 (6%) Sternum, Degeneration, Cystic 1 (2%) 3 (6%) 1 (2%) 5 (11%) Sternum, Fibrous Osteodystrophy 26 (55%) 21 (44%) 19 (40%) 21 (45%) Skeletal Muscle (47) (48) (47) (46) Mineralization 2 (4%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (47) (48) (47) (47) Cerebellum, Infiltration Cellular, Lymphocytic 1 (2%) Cerebrum, Mineralization 15 (32%) 18 (38%) 21 (45%) 21 (45%) Cerebrum, Polyarteritis 1 (2%) Spinal Cord (47) (48) (47) (47) Thoracic, Infiltration Cellular, Lymphocytic 1 (2%) Thoracic, Axon, Degeneration 12 (26%) 11 (23%) 9 (19%) 14 (30%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM a Number of animals examined microscopically at site and number of animals with lesion Page 6 NTP Experiment-Test: 93029-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC LEUKOMALACHITE GREEN Date: 06/19/03 Route: DOSED FEED Time: 07:04:42 ____________________________________________________________________________________________________________________________________ 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%) 1 (2%) Hemorrhage, Focal 1 (2%) Infarct 1 (2%) Infiltration Cellular, Histiocytic 1 (2%) 2 (4%) 2 (4%) Infiltration Cellular, Lymphocytic 13 (28%) 7 (15%) 9 (19%) 12 (26%) Inflammation, Chronic, Focal 1 (2%) 1 (2%) 1 (2%) Inflammation, Granulomatous 1 (2%) Leukocytosis 2 (4%) 1 (2%) Alveolar Epithelium, Hyperplasia 1 (2%) 1 (2%) 1 (2%) 1 (2%) Artery, Mineralization 1 (2%) Vein, Thrombosis 1 (2%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (47) (48) (47) (47) Phthisis Bulbi 1 (2%) Bilateral, Lens, Cataract 4 (9%) 5 (10%) 3 (6%) 7 (15%) Conjunctiva, Polyarteritis 1 (2%) Cornea, Inflammation, Chronic 1 (2%) Lens, Cataract 5 (11%) 4 (8%) 4 (9%) 4 (9%) Harderian Gland (47) (48) (47) (47) Atrophy 1 (2%) Hyperplasia 1 (2%) 1 (2%) 3 (6%) Infiltration Cellular, Lymphocytic 4 (9%) 9 (19%) 8 (17%) 5 (11%) Acinus, Dilatation 1 (2%) Zymbal's Gland (47) (47) (46) (47) Atrophy 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (47) (48) (47) (47) Glomerulosclerosis 1 (2%) 1 (2%) Hematopoietic Cell Proliferation 1 (2%) Infarct 2 (4%) 1 (2%) 1 (2%) Infiltration Cellular, Lymphocytic 9 (19%) 5 (10%) 15 (32%) 11 (23%) Nephropathy 1 (2%) 2 (4%) 3 (6%) 1 (2%) Polyarteritis 1 (2%) Glomerulus, Casts Protein 1 (2%) 1 (2%) Papilla, Casts Protein 1 (2%) Pelvis, Dilatation 2 (4%) 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 7 NTP Experiment-Test: 93029-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC LEUKOMALACHITE GREEN Date: 06/19/03 Route: DOSED FEED Time: 07:04:42 ____________________________________________________________________________________________________________________________________ C57BL/6N XC3H/HEN MTN-NCTR FEMALE 0 PPM 91 PPM 204 PPM 408 PPM ____________________________________________________________________________________________________________________________________ URINARY SYSTEM - CONT Renal Tubule, Accumulation, Hyaline Droplet 1 (2%) 2 (4%) 1 (2%) 3 (6%) Renal Tubule, Hyperplasia 1 (2%) Renal Tubule, Hypertrophy 1 (2%) Renal Tubule, Necrosis 1 (2%) Renal Tubule, Pigmentation 1 (2%) Urinary Bladder (46) (48) (47) (44) Inclusion Body Intracytoplasmic 14 (30%) 33 (69%) 44 (94%) 44 (100%) Infiltration Cellular, Lymphocytic 29 (63%) 22 (46%) 24 (51%) 26 (59%) Polyarteritis 1 (2%) Submucosa, Edema 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 8 ------------------------------------------------------------ ---------- END OF REPORT ---------- ------------------------------------------------------------