TDMS Study 96003-03 Pathology Tables
NTP Experiment-Test: 96003-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: 39 WEEKS ALLYL BROMIDE Date: 03/30/01 Route: GAVAGE Time: 09:19:05 FINAL#1/MICE Facility: BIORELIANCE Chemical CAS #: 106-95-6 Lock Date: 10/18/00 Cage Range: All Reasons For Removal: All Removal Date Range: All Treatment Groups: Include 008 VEHICLE CONTROL Include 009 0.5 MG/KG Include 010 1 MG/KG Include 011 2 MG/KG Include 012 4 MG/KG Include 013 8 MG/KG Include 001 VEHICLE CONTROL Include 002 0.5 MG/KG Include 003 1 MG/KG Include 004 2 MG/KG Include 005 4 MG/KG Include 006 8 MG/KG a Number of animals examined microscopically at site and number of animals with lesion Page 1 NTP Experiment-Test: 96003-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: 39 WEEKS ALLYL BROMIDE Date: 03/30/01 Route: GAVAGE Time: 09:19:05 ____________________________________________________________________________________________________________________________________ MICE:TGAC (FVB/N) HEMIZYGOUS FEMALE VEHICLE 0.5 1 MG/KG 2 MG/KG 4 MG/KG 8 MG/KG CONTROL MG/KG ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 15 15 15 15 15 15 Early Deaths Dosing Accident 2 Moribund Sacrifice 2 3 4 6 1 3 Natural Death 2 2 3 1 3 Survivors Terminal Sacrifice 9 10 8 8 11 12 Animals Examined Microscopically 15 15 15 15 15 15 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Esophagus (2) Muscularis, Epithelium, Necrosis, Diffuse 1 (50%) Muscularis, Periesophageal Tissue, Inflammation, Chronic Active, Focal 1 (50%) Periesophageal Tissue, Foreign Body, Focal 1 (50%) Intestine Small, Duodenum (13) (14) (11) (12) (13) (15) Serosa, Inflammation, Acute, Focal 1 (8%) Liver (15) (15) (15) (15) (14) (15) Hematopoietic Cell Proliferation 1 (7%) 1 (7%) 1 (7%) Infiltration Cellular, Diffuse, Polymorphonuclear 1 (7%) 1 (7%) Inflammation, Acute, Focal 1 (7%) 1 (7%) Inflammation, Chronic Active, Diffuse 1 (7%) Necrosis, Chronic Active, Focal 1 (7%) Necrosis, Focal 2 (13%) 2 (13%) 3 (20%) 2 (13%) 1 (7%) 2 (13%) Centrilobular, Vacuolization Cytoplasmic 1 (7%) Hepatocyte, Degeneration, Focal 1 (7%) Hepatocyte, Necrosis, Focal 1 (7%) 1 (7%) 3 (20%) 5 (33%) 3 (21%) 4 (27%) Hepatocyte, Vacuolization Cytoplasmic, Diffuse 4 (27%) 5 (33%) 3 (20%) 4 (29%) 3 (20%) Hepatocyte, Vacuolization Cytoplasmic, Focal 2 (13%) 2 (13%) 1 (7%) 4 (27%) 2 (14%) 3 (20%) Hepatocyte, Periportal, Vacuolization Cytoplasmic 1 (7%) 2 (13%) Hepatocyte, Centrilobular, Vacuolization Cytoplasmic 1 (7%) Serosa, Inflammation, Acute, Focal 1 (7%) Pancreas (1) (1) (1) (3) Inflammation, Acute, Diffuse 1 (33%) Necrosis, Focal 1 (100%) a Number of animals examined microscopically at site and number of animals with lesion Page 2 NTP Experiment-Test: 96003-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: 39 WEEKS ALLYL BROMIDE Date: 03/30/01 Route: GAVAGE Time: 09:19:05 ____________________________________________________________________________________________________________________________________ MICE:TGAC (FVB/N) HEMIZYGOUS FEMALE VEHICLE 0.5 1 MG/KG 2 MG/KG 4 MG/KG 8 MG/KG CONTROL MG/KG ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Acinus, Atrophy, Diffuse 1 (100%) Stomach, Forestomach (14) (15) (12) (13) (14) (15) Muscularis, Serosa, Inflammation, Acute, Focal 1 (7%) Stomach, Glandular (13) (14) (11) (13) (13) (15) Serosa, Inflammation, Acute, Focal 1 (8%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Blood Vessel (1) Aorta, Inflammation, Chronic Active, Focal 1 (100%) Heart (1) (1) Atrium, Thrombosis, Focal 1 (100%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (13) (14) (12) (13) (12) (15) Atrophy 4 (31%) 6 (43%) 9 (75%) 3 (23%) 11 (92%) 4 (27%) Mineralization, Focal 1 (7%) Subcapsular, Hyperplasia, Focal 2 (15%) 4 (29%) 3 (25%) 9 (69%) 5 (42%) 6 (40%) Zona Reticularis, Hyperplasia, Diffuse 1 (8%) Zona Reticularis, Infiltration Cellular, Focal, Lymphocyte 1 (8%) Zona Reticularis, Vacuolization Cytoplasmic, Diffuse 6 (46%) 8 (57%) 6 (50%) 10 (77%) 9 (75%) 12 (80%) Zona Reticularis, Vacuolization Cytoplasmic, Focal 6 (46%) 4 (29%) 5 (42%) 2 (15%) 1 (8%) 3 (20%) Thyroid Gland (13) (13) (12) (14) (12) (14) Ectopic Thymus 1 (8%) 1 (8%) Follicle, Cyst, Focal 1 (8%) 1 (8%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Ovary (13) (15) (14) (14) (13) (15) Angiectasis, Focal 1 (7%) a Number of animals examined microscopically at site and number of animals with lesion Page 3 NTP Experiment-Test: 96003-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: 39 WEEKS ALLYL BROMIDE Date: 03/30/01 Route: GAVAGE Time: 09:19:05 ____________________________________________________________________________________________________________________________________ MICE:TGAC (FVB/N) HEMIZYGOUS FEMALE VEHICLE 0.5 1 MG/KG 2 MG/KG 4 MG/KG 8 MG/KG CONTROL MG/KG ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM - CONT Atrophy 2 (13%) 2 (14%) 1 (8%) Cyst 1 (7%) 1 (8%) Cyst, Focal 1 (7%) Degeneration 1 (8%) 2 (14%) 1 (7%) 1 (8%) 1 (7%) Inflammation, Acute, Diffuse 1 (8%) Inflammation, Chronic Active, Diffuse 1 (8%) Inflammation, Diffuse 1 (7%) Bilateral, Inflammation, Chronic Active, Diffuse 1 (8%) Bilateral, Periovarian Tissue, Cyst 1 (8%) Corpus Luteum, Inflammation, Chronic Active, Focal 1 (7%) Periovarian Tissue, Inflammation, Acute, Focal 1 (7%) Periovarian Tissue, Inflammation, Chronic Active, Diffuse 1 (8%) Periovarian Tissue, Inflammation, Chronic Active, Focal 1 (7%) 1 (7%) Periovarian Tissue, Rete Ovarii, Inflammation, Acute, Focal 1 (7%) 1 (8%) Uterus (13) (15) (13) (14) (12) (15) Atrophy 1 (8%) Hydrometra 1 (7%) 2 (14%) Inflammation, Acute, Diffuse 1 (7%) Inflammation, Acute, Focal 1 (8%) Inflammation, Chronic Active, Diffuse 1 (8%) Endometrium, Hyperplasia, Cystic 11 (85%) 10 (67%) 8 (62%) 4 (29%) 10 (83%) 13 (87%) Endometrium, Inflammation, Acute, Focal 1 (8%) Serosa, Inflammation, Acute, Focal 1 (8%) Vagina (1) Inflammation, Chronic Active, Diffuse 1 (100%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Lymph Node (1) Iliac, Hyperplasia 1 (100%) Renal, Hyperplasia 1 (100%) Lymph Node, Mandibular (14) (15) (12) (14) (12) (15) Hyperplasia 2 (14%) 1 (7%) 2 (17%) 2 (13%) Inflammation, Acute, Focal 1 (8%) Necrosis, Focal 1 (7%) Lymph Node, Mesenteric (13) (14) (12) (15) (12) (15) a Number of animals examined microscopically at site and number of animals with lesion Page 4 NTP Experiment-Test: 96003-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: 39 WEEKS ALLYL BROMIDE Date: 03/30/01 Route: GAVAGE Time: 09:19:05 ____________________________________________________________________________________________________________________________________ MICE:TGAC (FVB/N) HEMIZYGOUS FEMALE VEHICLE 0.5 1 MG/KG 2 MG/KG 4 MG/KG 8 MG/KG CONTROL MG/KG ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - CONT Hyperplasia 1 (8%) Lymph Node, Mediastinal (14) (15) (14) (14) (12) (14) Atrophy 1 (7%) Hyperplasia 1 (7%) 1 (8%) Inflammation, Diffuse 1 (7%) Spleen (15) (14) (15) (15) (13) (15) Hematopoietic Cell Proliferation 13 (87%) 11 (79%) 15 (100%) 13 (87%) 12 (92%) 14 (93%) Pigmentation 10 (67%) 11 (79%) 10 (67%) 14 (93%) 11 (85%) 14 (93%) Capsule, Inflammation, Acute, Focal 2 (15%) Lymphoid Follicle, Depletion Cellular 1 (7%) 1 (7%) 1 (7%) Thymus (13) (13) (12) (13) (11) (15) Atrophy, Diffuse 5 (38%) 3 (23%) 2 (15%) 1 (7%) Atrophy, Focal 2 (15%) 1 (8%) 3 (23%) 2 (18%) 6 (40%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (1) Dilatation, Focal 1 (100%) Skin (15) (15) (15) (15) (14) (15) Dermis, Fibrosis, Focal 1 (7%) Dermis, Subcutaneous Tissue, Inflammation, Chronic Active, Diffuse 1 (7%) Epidermis, Hyperplasia, Focal 1 (7%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM None ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM None ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (14) (15) (15) (15) (14) (15) Alveolus, Hemorrhage, Focal 1 (7%) 1 (7%) Alveolus, Hyperplasia, Focal, Histiocytic 1 (7%) Alveolus, Inflammation, Chronic, Focal 1 (7%) Arteriole, Necrosis, Focal 1 (7%) a Number of animals examined microscopically at site and number of animals with lesion Page 5 NTP Experiment-Test: 96003-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: 39 WEEKS ALLYL BROMIDE Date: 03/30/01 Route: GAVAGE Time: 09:19:05 ____________________________________________________________________________________________________________________________________ MICE:TGAC (FVB/N) HEMIZYGOUS FEMALE VEHICLE 0.5 1 MG/KG 2 MG/KG 4 MG/KG 8 MG/KG CONTROL MG/KG ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM - CONT Mediastinum, Inflammation, Acute, Focal 1 (7%) 1 (7%) Perivascular, Infiltration Cellular, Lymphocyte 1 (7%) 1 (7%) 1 (7%) Serosa, Mediastinum, Inflammation, Chronic Active, Focal 1 (7%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM None ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (15) (14) (14) (15) (13) (15) Infiltration Cellular, Focal, Lymphocyte 1 (7%) Inflammation, Chronic Active, Focal 1 (7%) 1 (8%) Necrosis, Focal 1 (7%) Bilateral, Inflammation, Acute, Focal 1 (7%) 1 (7%) Bilateral, Nephropathy, Diffuse 1 (7%) Capsule, Inflammation, Acute, Focal 1 (7%) Cortex, Inflammation, Acute, Focal 1 (7%) Cortex, Pelvis, Inflammation, Chronic Active, Focal 1 (7%) Papilla, Inflammation, Acute, Focal 1 (7%) Renal Tubule, Degeneration, Focal 1 (7%) Renal Tubule, Dilatation, Diffuse 1 (7%) 1 (7%) 1 (7%) Renal Tubule, Dilatation, Focal 2 (13%) 1 (8%) a Number of animals examined microscopically at site and number of animals with lesion Page 6 NTP Experiment-Test: 96003-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: 39 WEEKS ALLYL BROMIDE Date: 03/30/01 Route: GAVAGE Time: 09:19:05 ____________________________________________________________________________________________________________________________________ MICE:TGAC (FVB/N) HEMIZYGOUS MALE VEHICLE 0.5 1 MG/KG 2 MG/KG 4 MG/KG 8 MG/KG CONTROL MG/KG ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 15 15 15 15 15 15 Early Deaths Moribund Sacrifice 2 2 3 2 4 1 Natural Death 1 3 3 4 2 Dosing Accident 1 1 1 1 Survivors Terminal Sacrifice 12 9 9 12 6 11 Animals Examined Microscopically 15 15 15 15 15 15 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Esophagus (1) (1) (1) (1) Muscularis, Periesophageal Tissue, Inflammation, Chronic Active, Diffuse 1 (100%) Periesophageal Tissue, Inflammation, Chronic Active, Diffuse 1 (100%) 1 (100%) Periesophageal Tissue, Inflammation, Chronic Active, Focal 1 (100%) Liver (14) (15) (14) (15) (14) (15) Necrosis, Focal 1 (7%) 1 (7%) Hepatocyte, Necrosis, Focal 2 (14%) 3 (20%) 5 (36%) 2 (14%) Hepatocyte, Vacuolization Cytoplasmic, Diffuse 1 (7%) Hepatocyte, Vacuolization Cytoplasmic, Focal 1 (7%) 1 (7%) 2 (13%) Hepatocyte, Centrilobular, Hypertrophy 1 (7%) Hepatocyte, Centrilobular, Vacuolization Cytoplasmic 2 (14%) 2 (14%) 1 (7%) Serosa, Inflammation, Chronic Active, Focal 1 (7%) Sinusoid, Inflammation, Focal 1 (7%) Mesentery (1) (1) (2) Fat, Necrosis, Focal 1 (100%) 1 (100%) 2 (100%) Pancreas (1) Acinus, Atrophy, Diffuse 1 (100%) Salivary Glands (1) (1) (1) Necrosis, Focal 1 (100%) Tooth (5) (5) (4) (3) (6) (4) Peridontal Tissue, Inflammation, Chronic Active, Focal 1 (25%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 7 NTP Experiment-Test: 96003-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: 39 WEEKS ALLYL BROMIDE Date: 03/30/01 Route: GAVAGE Time: 09:19:05 ____________________________________________________________________________________________________________________________________ MICE:TGAC (FVB/N) HEMIZYGOUS MALE VEHICLE 0.5 1 MG/KG 2 MG/KG 4 MG/KG 8 MG/KG CONTROL MG/KG ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM None ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (15) (14) (14) (14) (12) (14) Atrophy 15 (100%) 13 (93%) 14 (100%) 14 (100%) 10 (83%) 12 (86%) Degeneration, Focal 1 (7%) Hypertrophy, Focal 13 (87%) 10 (71%) 9 (64%) 11 (79%) 10 (83%) 11 (79%) Subcapsular, Hyperplasia, Focal 1 (7%) Zona Reticularis, Vacuolization Cytoplasmic, Focal 1 (7%) 1 (7%) 1 (8%) 1 (7%) Thyroid Gland (15) (13) (14) (15) (9) (14) Inflammation, Chronic Active, Focal 1 (8%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM Tissue NOS (1) (1) Fat, Necrosis, Focal 1 (100%) Mediastinum, Inflammation, Chronic Active, Focal 1 (100%) ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Preputial Gland (1) (2) (2) (1) (4) (2) Ectasia 1 (100%) 1 (50%) 2 (100%) 1 (100%) 4 (100%) 2 (100%) Inflammation, Chronic Active, Focal 1 (50%) Seminal Vesicle (1) (1) Dilatation 1 (100%) Bilateral, Dilatation 1 (100%) Testes (15) (15) (15) (15) (14) (14) Germinal Epithelium, Degeneration, Diffuse 1 (7%) Germinal Epithelium, Degeneration, Focal 1 (7%) 5 (33%) 1 (7%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Lymph Node, Mandibular (15) (13) (14) (15) (13) (15) Hyperplasia 1 (7%) 1 (8%) 2 (14%) 3 (23%) 1 (7%) a Number of animals examined microscopically at site and number of animals with lesion Page 8 NTP Experiment-Test: 96003-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: 39 WEEKS ALLYL BROMIDE Date: 03/30/01 Route: GAVAGE Time: 09:19:05 ____________________________________________________________________________________________________________________________________ MICE:TGAC (FVB/N) HEMIZYGOUS MALE VEHICLE 0.5 1 MG/KG 2 MG/KG 4 MG/KG 8 MG/KG CONTROL MG/KG ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - CONT Hyperplasia, Histiocytic 1 (8%) Lymph Node, Mesenteric (14) (14) (14) (15) (12) (14) Hyperplasia 1 (7%) Inflammation, Chronic Active, Focal 1 (7%) Lymph Node, Mediastinal (14) (13) (14) (15) (10) (14) Hyperplasia 1 (8%) 1 (7%) Spleen (15) (14) (14) (15) (14) (15) Congestion 1 (7%) 1 (7%) Hematopoietic Cell Proliferation 14 (93%) 14 (100%) 13 (93%) 15 (100%) 12 (86%) 13 (87%) Inflammation, Chronic Active, Focal 1 (7%) Pigmentation 8 (53%) 10 (71%) 9 (64%) 12 (80%) 6 (43%) 11 (73%) Lymphoid Follicle, Depletion Cellular 1 (7%) 1 (7%) 1 (7%) 1 (7%) Thymus (15) (13) (12) (15) (10) (13) Atrophy, Diffuse 3 (20%) 3 (23%) 2 (17%) 2 (13%) 3 (30%) 1 (8%) Atrophy, Focal 1 (7%) 2 (15%) 1 (8%) 4 (27%) 1 (10%) 1 (8%) Hyperplasia 2 (17%) Hyperplasia, Focal 1 (10%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Skin (15) (15) (15) (15) (14) (15) Hyperkeratosis, Focal 1 (7%) Dermis, Inflammation, Chronic Active, Focal 1 (7%) Epidermis, Hyperplasia, Focal 1 (7%) 2 (13%) Subcutaneous Tissue, Inflammation, Chronic Active, Focal 1 (7%) 1 (7%) Subcutaneous Tissue, Necrosis, Focal 1 (7%) 1 (7%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM None ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM None ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (15) (15) (14) (15) (14) (15) a Number of animals examined microscopically at site and number of animals with lesion Page 9 NTP Experiment-Test: 96003-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: 39 WEEKS ALLYL BROMIDE Date: 03/30/01 Route: GAVAGE Time: 09:19:05 ____________________________________________________________________________________________________________________________________ MICE:TGAC (FVB/N) HEMIZYGOUS MALE VEHICLE 0.5 1 MG/KG 2 MG/KG 4 MG/KG 8 MG/KG CONTROL MG/KG ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM - CONT Inflammation, Chronic Active, Focal 1 (7%) Alveolar Epithelium, Hyperplasia, Focal 1 (7%) Alveolus, Hemorrhage, Focal 1 (7%) 1 (7%) 1 (7%) Arteriole, Artery, Inflammation, Chronic Active, Focal 2 (14%) Arteriole, Capillary, Perivascular, Inflammation, Acute 1 (7%) Mediastinum, Inflammation, Chronic Active, Diffuse 1 (7%) Perivascular, Infiltration Cellular, Focal, Lymphocyte 1 (7%) 1 (7%) Perivascular, Infiltration Cellular, Lymphocyte 1 (7%) 1 (7%) 1 (7%) Serosa, Mediastinum, Inflammation, Chronic Active, Diffuse 1 (7%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (1) (1) Retina, Atrophy 1 (100%) 1 (100%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (15) (14) (14) (15) (14) (14) Inflammation, Acute, Focal 1 (7%) Inflammation, Chronic Active, Focal 1 (7%) Bilateral, Cortex, Inflammation, Acute, Focal 1 (7%) Capsule, Cortex, Inflammation, Chronic Active, Focal 1 (7%) Cortex, Inflammation, Acute, Focal 2 (14%) Renal Tubule, Degeneration, Focal 2 (14%) Renal Tubule, Dilatation, Diffuse 1 (7%) 1 (7%) Renal Tubule, Dilatation, Focal 1 (7%) 1 (7%) 1 (7%) 1 (7%) a Number of animals examined microscopically at site and number of animals with lesion Page 10 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