TDMS Study 93005-03 Pathology Tables
NTP Experiment-Test: 93005-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18 Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 06/18/03 Route: DOSED FEED MALACHITE GREEN Time: 14:30:44 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 b Average severity grade (1-minimal;2-mild;3-moderate;4-marked) Page 1 NTP Experiment-Test: 93005-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18 Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 06/18/03 Route: DOSED FEED MALACHITE GREEN Time: 14:30:44 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 PPM 100 PPM 300 PPM 600 PPM ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 48 48 48 48 Early Deaths Natural Death 1 3 1 6 Moribund Sacrifice 18 22 15 17 Survivors Terminal Sacrifice 29 23 32 25 Animals Examined Microscopically 48 48 48 48 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Esophagus (48) (48) (48) (48) Dilatation 1 [3.0] Foreign Body 1 Intestine Small, Ileum (47) (46) (48) (47) Dilatation 1 [3.0] Liver (48) (48) (48) (48) Angiectasis 1 [2.0] Basophilic Focus 2 3 2 7 Basophilic Focus, Multiple 19 14 18 8 Clear Cell Focus 2 Clear Cell Focus, Multiple 1 Cyst 1 [2.0] Degeneration, Cystic 1 [2.0] Developmental Malformation 4 [0.0] 7 [0.0] 2 [0.0] 5 [1.0] Eosinophilic Focus 3 9 3 11 Eosinophilic Focus, Multiple 2 1 10 3 Fatty Change 1 [2.0] Hematopoietic Cell Proliferation 2 [1.5] 3 [1.0] 4 [1.0] 5 [1.8] Hepatodiaphragmatic Nodule 3 6 2 3 Infiltration Cellular, Lymphocyte 2 [1.0] 3 [1.3] 3 [1.0] 8 [1.0] Inflammation, Focal, Granulomatous 18 [1.6] 15 [1.5] 23 [1.5] 19 [1.3] Inflammation, Focal, Suppurative 1 [1.0] 2 [2.5] Mixed Cell Focus 2 Mixed Cell Focus, Multiple 1 Necrosis 2 [1.5] 2 [1.5] 1 [1.0] Vacuolization Cytoplasmic 4 [2.3] 4 [2.8] 1 [3.0] 6 [1.8] Bile Duct, Cyst 1 [2.0] Bile Duct, Hyperplasia 10 [1.4] 10 [1.7] 9 [1.4] 5 [1.2] Centrilobular, Necrosis 4 [2.5] Mesentery (9) (5) (2) (4) 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: 93005-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18 Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 06/18/03 Route: DOSED FEED MALACHITE GREEN Time: 14:30:44 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 PPM 100 PPM 300 PPM 600 PPM ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Fat, Necrosis 7 [2.6] 4 [3.0] 2 [2.5] 3 [2.7] Pancreas (48) (48) (48) (48) Infiltration Cellular, Lymphocyte 1 [1.0] 2 [1.0] Inflammation 1 [2.0] Acinus, Atrophy 13 [1.2] 14 [1.6] 12 [1.3] 7 [1.1] Salivary Glands (48) (47) (48) (48) Atrophy 2 [1.5] 1 [1.0] 1 [2.0] Infiltration Cellular, Lymphocyte 1 [1.0] 1 [1.0] Stomach, Forestomach (48) (48) (48) (48) Edema 1 [2.0] Erosion 1 [2.0] Inflammation 1 [3.0] 2 [2.0] 1 [3.0] Necrosis 1 [2.0] Epithelium, Hyperplasia 1 [2.0] 1 [1.0] ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (48) (48) (48) (48) Cardiomyopathy 13 [1.5] 22 [1.1] 19 [1.1] 14 [1.2] Atrium, Thrombosis 1 [2.0] ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (48) (48) (48) (48) Accessory Adrenal Cortical Nodule 1 [2.0] 1 [2.0] Angiectasis 10 [1.3] 11 [1.5] 17 [1.5] 16 [1.6] Atrophy 2 [2.0] Hematopoietic Cell Proliferation 1 [1.0] Hyperplasia, Focal 1 [2.0] 1 [2.0] 1 [2.0] Hypertrophy, Focal 1 [2.0] 4 [1.5] 1 [2.0] 4 [1.8] Infiltration Cellular, Lymphocyte 1 [1.0] Vacuolization Cytoplasmic 6 [1.3] 5 [1.8] 2 [1.5] 3 [1.3] Adrenal Medulla (47) (47) (48) (48) Hyperplasia 1 [1.0] 3 [2.3] 1 [3.0] 1 [1.0] Islets, Pancreatic (48) (48) (48) (48) Hyperplasia 1 [2.0] Parathyroid Gland (43) (43) (45) (39) Hyperplasia, Focal 1 [2.0] Pituitary Gland (48) (47) (46) (45) Angiectasis 5 [2.4] 2 [1.5] 2 [2.0] 2 [2.0] Pars Distalis, Cyst 8 [1.5] 5 [1.4] 9 [1.9] 9 [1.9] 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: 93005-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18 Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 06/18/03 Route: DOSED FEED MALACHITE GREEN Time: 14:30:44 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 PPM 100 PPM 300 PPM 600 PPM ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM - CONT Pars Distalis, Hyperplasia 5 [2.0] 11 [2.2] 6 [1.8] Pars Intermedia, Cyst 1 [2.0] Thyroid Gland (46) (48) (47) (46) C-Cell, Hyperplasia 8 [1.4] 5 [1.4] 11 [1.4] 6 [1.7] Follicle, Cyst 1 [3.0] 1 [3.0] 3 [2.0] Follicular Cell, Hyperplasia 1 [1.0] 2 [1.0] ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Clitoral Gland (48) (48) (47) (47) Hyperplasia 5 [2.2] 4 [2.0] 2 [2.0] 6 [2.2] Inflammation 21 [2.1] 30 [2.2] 23 [2.2] 26 [2.2] Metaplasia, Squamous 1 [2.0] Duct, Dilatation 6 [2.8] 5 [2.8] 7 [2.6] 6 [2.7] Ovary (48) (48) (47) (48) Atrophy 18 [2.4] 14 [2.1] 11 [2.5] 10 [2.0] Congestion 1 [3.0] Cyst 5 [2.4] 4 [2.3] 7 [2.0] 10 [2.1] Cyst, Multiple 1 [2.0] Infiltration Cellular, Lymphocyte 1 [3.0] Interstitial Cell, Hyperplasia 1 [3.0] Uterus (48) (48) (48) (48) Decidual Reaction 1 [2.0] Hemorrhage 1 [4.0] Inflammation, Suppurative 1 [2.0] Thrombosis 1 [3.0] 1 [3.0] Cervix, Hypertrophy 1 [3.0] 1 [3.0] 1 [2.0] Cervix, Serosa, Cyst 1 [3.0] Endometrium, Hyperplasia, Cystic 6 [2.0] 3 [1.7] 11 [1.8] 8 [1.8] Vagina (48) (48) (48) (48) Inflammation, Suppurative 3 [2.0] 3 [2.3] 5 [2.0] 1 [2.0] Prolapse 2 [3.0] ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (48) (48) (48) (48) 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: 93005-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18 Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 06/18/03 Route: DOSED FEED MALACHITE GREEN Time: 14:30:44 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 PPM 100 PPM 300 PPM 600 PPM ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - CONT Atrophy 1 [2.0] 3 [1.7] 2 [2.0] 2 [2.0] Myelofibrosis 2 [2.0] Myelostromal Proliferation 1 [2.0] Myeloid Cell, Hyperplasia 5 [2.0] 5 [2.0] 4 [2.3] Lymph Node (10) (7) (7) (5) Pigmentation 1 [2.0] Deep Cervical, Hemorrhage 1 [2.0] Deep Cervical, Hyperplasia, Lymphoid 1 [2.0] 1 [2.0] Iliac, Hyperplasia, Lymphoid 1 [2.0] Lumbar, Ectasia 2 [3.0] Lumbar, Hematopoietic Cell Proliferation 1 [2.0] Lumbar, Hemorrhage 1 [2.0] 1 [1.0] Lumbar, Hyperplasia, Lymphoid 2 [2.0] 1 [4.0] Mediastinal, Hemorrhage 1 [2.0] 1 [2.0] 3 [2.3] Mediastinal, Hyperplasia, Lymphoid 2 [2.0] Pancreatic, Hematopoietic Cell Proliferation 1 [3.0] Pancreatic, Hemorrhage 1 [2.0] Pancreatic, Hyperplasia, Lymphoid 1 [2.0] 1 [2.0] Renal, Ectasia 1 [3.0] Renal, Hemorrhage 2 [2.0] 1 [1.0] Renal, Hyperplasia, Lymphoid 1 [2.0] 1 [2.0] Lymph Node, Mandibular (47) (46) (47) (48) Ectasia 1 [2.0] Hemorrhage 2 [2.5] Hyperplasia, Lymphoid 1 [2.0] 3 [2.0] 2 [2.0] 5 [2.6] Infiltration Cellular, Plasma Cell 5 [2.2] 5 [2.0] 5 [2.2] 7 [2.0] Lymph Node, Mesenteric (47) (47) (48) (48) Ectasia 1 [2.0] Hemorrhage 1 [2.0] 1 [2.0] Hyperplasia, Lymphoid 2 [2.0] Infiltration Cellular, Plasma Cell 1 [3.0] 1 [2.0] Spleen (48) (48) (48) (48) Atrophy 1 [3.0] Fibrosis 1 [3.0] Hematopoietic Cell Proliferation 6 [2.8] 2 [2.0] 7 [2.3] 12 [2.2] Hyperplasia, Focal 1 [4.0] Pigmentation 1 [3.0] 2 [3.0] 2 [3.0] 3 [3.0] Thrombosis 1 [3.0] Capsule, Hemorrhage 1 [3.0] Thymus (40) (42) (43) (40) Cyst 1 [2.0] Ectopic Parathyroid Gland 1 [2.0] Hemorrhage 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: 93005-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18 Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 06/18/03 Route: DOSED FEED MALACHITE GREEN Time: 14:30:44 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 PPM 100 PPM 300 PPM 600 PPM ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - CONT Hyperplasia, Reticulum Cell 1 [3.0] ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (46) (48) (48) (48) Galactocele 4 [2.5] 8 [3.0] 2 [2.5] 2 [2.5] Hyperplasia 28 [2.1] 33 [1.8] 29 [1.9] 35 [2.0] Inflammation 1 [3.0] Duct, Dilatation 12 [2.0] 22 [1.9] 18 [1.9] 11 [2.1] Skin (48) (48) (48) (48) Hyperkeratosis 2 [2.5] Inflammation 1 [3.0] Epidermis, Hyperplasia 1 [2.0] Epidermis, Necrosis 2 [2.0] ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (48) (48) (48) (48) Femur, Fibrous Osteodystrophy 1 [3.0] 1 [2.0] 3 [1.0] Femur, Osteopetrosis 8 [2.6] 3 [2.0] 3 [2.7] 3 [2.3] Sternum, Fibrous Osteodystrophy 1 [2.0] Sternum, Osteopetrosis 8 [2.6] 3 [2.0] 3 [2.7] 3 [2.3] Turbinate, Osteopetrosis 7 [2.7] 2 [2.5] 2 [3.0] 2 [2.5] ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (48) (48) (48) (48) Hemorrhage 1 [1.0] 1 [2.0] Hypothalamus, Compression 5 [1.8] 14 [2.0] 10 [2.3] 7 [2.3] Spinal Cord (48) (48) (48) (48) Hemorrhage 1 [1.0] ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (48) (48) (48) (48) Foreign Body 1 [2.0] 4 [2.8] Hemorrhage 2 [1.5] Inflammation, Chronic, Diffuse 1 [2.0] Inflammation, Chronic, Focal 1 [2.0] 3 [1.7] 4 [1.8] 8 [1.9] 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: 93005-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18 Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 06/18/03 Route: DOSED FEED MALACHITE GREEN Time: 14:30:44 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 PPM 100 PPM 300 PPM 600 PPM ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM - CONT Alveolar Epithelium, Hyperplasia, Focal 1 [2.0] 1 [2.0] 2 [3.0] Alveolus, Infiltration Cellular, Histiocyte 1 [1.0] 1 [2.0] Nose (48) (48) (48) (48) Foreign Body 1 [2.0] 2 [3.0] Inflammation, Chronic 1 [2.0] Inflammation, Suppurative 1 [3.0] 2 [3.0] Nasolacrimal Duct, Inflammation 19 [1.7] 10 [1.6] 11 [1.7] 13 [1.7] Olfactory Epithelium, Cytoplasmic Alteration 2 [2.5] 3 [2.3] 6 [1.8] 1 [1.0] Olfactory Epithelium, Respiratory Epithelium, Cytoplasmic Alteration 1 [2.0] 2 [3.0] Respiratory Epithelium, Cytoplasmic Alteration 1 [1.0] Trachea (48) (48) (48) (48) Inflammation 3 [1.7] 1 [3.0] Epithelium, Hyperplasia 1 [2.0] 2 [2.5] ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (47) (48) (48) (48) Cataract 7 [1.4] 2 [1.5] 7 [1.9] Hemorrhage 1 [2.0] Phthisis Bulbi 2 Bilateral, Cataract 1 [1.0] 1 [2.0] 2 [2.0] 2 [2.0] Bilateral, Retina, Degeneration 13 [2.8] 14 [2.1] 20 [2.2] 18 [2.3] Cornea, Inflammation 1 [3.0] Retina, Autolysis 1 4 2 Retina, Degeneration 8 [2.1] 8 [2.0] 9 [1.9] 9 [2.1] Sclera, Metaplasia, Osseous 1 [2.0] Harderian Gland (47) (48) (48) (48) Atrophy 1 [1.0] Infiltration Cellular, Lymphocyte 34 [1.4] 37 [1.2] 36 [1.3] 32 [1.4] Inflammation 1 [3.0] Pigmentation 1 [3.0] Lacrimal Gland (18) (14) (15) (9) Infiltration Cellular, Lymphocyte 2 [1.5] 2 [1.0] 2 [1.5] 3 [1.0] Metaplasia 18 [2.0] 14 [1.9] 15 [2.0] 9 [2.1] Zymbal's Gland (47) (48) (48) (46) Hyperplasia 1 [2.0] 1 [2.0] Metaplasia, Squamous 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 7 NTP Experiment-Test: 93005-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18 Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 06/18/03 Route: DOSED FEED MALACHITE GREEN Time: 14:30:44 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 PPM 100 PPM 300 PPM 600 PPM ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (48) (48) (48) (48) Hydronephrosis 1 [2.0] Mineralization 33 [2.0] 31 [2.0] 30 [1.9] 30 [1.8] Nephropathy 39 [1.4] 38 [1.6] 41 [1.4] 40 [1.5] Pelvis, Inflammation 1 [1.0] Pelvis, Transitional Epithelium, Hyperplasia 1 [1.0] Renal Tubule, Necrosis 1 [3.0] Urinary Bladder (47) (48) (47) (47) Infiltration Cellular, Lymphocyte 1 [1.0] 1 [1.0] 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 8 ------------------------------------------------------------ ---------- END OF REPORT ---------- ------------------------------------------------------------