TR 388 Mouse Pathology Tables
INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) ETHYLENETHIOUREA NTP Experiment-Test: 05076-02 Report: PEIRPT03 Study Type: CHRONIC Date: 09/10/94 Route: DOSED FEED Time: 02:00:00 Facility: Battelle Columbus Laboratory Chemical CAS #: 96-45-7 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: 05076-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC ETHYLENETHIOUREA Date: 09/10/94 Route: DOSED FEED Time: 02:00:00 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0 PPM 0 PPM 100 PPM 333 PPM 333 PPM 333 PPM 0-0 10-0 1-1 0-3 3-3 10-3 ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 50 50 29 50 50 50 Early Deaths Moribund Sacrifice 9 4 6 6 11 9 Natural Death 6 8 2 1 3 5 Survivors Terminal Sacrifice 34 37 21 42 34 36 Natural Death 1 1 1 2 Animals Examined Microscopically 50 50 29 50 50 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Colon (49) (12) (8) (9) (16) (12) Parasite Metazoan 1 (6%) Intestine Small, Jejunum (46) (12) (10) (8) (19) (13) Inflammation, Chronic Active 1 (8%) Necrosis 1 (8%) Peyer's Patch, Hyperplasia, Lymphoid 1 (10%) Liver (50) (49) (28) (50) (50) (50) Basophilic Focus 2 (4%) 1 (2%) 3 (6%) 2 (4%) 1 (2%) Clear Cell Focus 2 (4%) 1 (2%) 1 (2%) Eosinophilic Focus 2 (7%) 11 (22%) 4 (8%) 14 (28%) Fatty Change, Focal 1 (2%) Hematopoietic Cell Proliferation 8 (16%) 2 (4%) 1 (4%) 1 (2%) 4 (8%) 2 (4%) Hyperplasia, Lymphoid 1 (2%) Infarct 3 (6%) 2 (4%) 2 (7%) 5 (10%) 6 (12%) 4 (8%) Inflammation, Acute 1 (2%) 1 (2%) Inflammation, Chronic Active 2 (4%) 1 (2%) 1 (2%) Necrosis 2 (4%) 1 (2%) Vacuolization Cytoplasmic 1 (2%) Bile Duct, Mineralization, Multifocal 1 (2%) Centrilobular, Cytomegaly 2 (7%) 11 (22%) 8 (16%) 9 (18%) Centrilobular, Necrosis 1 (2%) Centrilobular, Necrosis, Acute 1 (2%) Centrilobular, Vacuolization Cytoplasmic 2 (4%) 1 (2%) Oval Cell, Hyperplasia 1 (2%) Mesentery (6) (2) (1) (1) (1) Inflammation, Chronic Active 2 (33%) 1 (100%) 1 (100%) Pancreas (50) (11) (8) (7) (16) (13) Acinus, Atrophy 2 (4%) 1 (13%) 1 (14%) 1 (6%) 2 (15%) Acinus, Inflammation, Chronic Active 1 (14%) Duct, Ectasia 2 (4%) 1 (6%) 2 (15%) Salivary Glands (50) (13) (8) (8) (15) (14) Perivascular, Inflammation, Chronic Active, Multifocal 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 2 NTP Experiment-Test: 05076-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC ETHYLENETHIOUREA Date: 09/10/94 Route: DOSED FEED Time: 02:00:00 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0 PPM 0 PPM 100 PPM 333 PPM 333 PPM 333 PPM 0-0 10-0 1-1 0-3 3-3 10-3 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Stomach, Forestomach (48) (15) (10) (11) (17) (14) Acanthosis 2 (18%) Cyst Epithelial Inclusion 2 (13%) 1 (10%) Diverticulum 1 (6%) Hyperkeratosis, Focal 1 (7%) Hyperplasia, Squamous 1 (10%) 3 (18%) Inflammation, Chronic Active 2 (13%) Stomach, Glandular (48) (11) (8) (8) (15) (13) Dysplasia 1 (2%) Subserosa, Inflammation, Chronic 1 (13%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (50) (13) (8) (8) (16) (14) Bacterium, Acute, Multiple 1 (2%) 2 (13%) Degeneration, Chronic 1 (6%) Inflammation, Acute 2 (13%) Inflammation, Chronic 1 (7%) Mineralization 1 (13%) 1 (13%) Thrombosis 1 (2%) 1 (13%) Interstitium, Hyperplasia, Diffuse 1 (7%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Gland, Cortex (49) (13) (8) (8) (16) (11) Degeneration, Fatty 4 (8%) Hematopoietic Cell Proliferation 1 (8%) Hyperplasia 1 (2%) Hypertrophy 3 (6%) 1 (6%) 1 (9%) Adrenal Gland, Medulla (48) (13) (8) (8) (16) (11) Hyperplasia 1 (13%) 1 (6%) Islets, Pancreatic (49) (13) (8) (7) (15) (12) Hyperplasia, Focal 1 (2%) Pituitary Gland (47) (48) (28) (49) (48) (47) Pars Distalis, Angiectasis 1 (2%) Pars Distalis, Hyperplasia 19 (40%) 19 (40%) 8 (29%) 22 (45%) 23 (48%) 18 (38%) Thyroid Gland (50) (49) (29) (50) (50) (49) Follicular Cell, Hyperplasia 2 (4%) 8 (16%) 13 (26%) 17 (34%) 22 (45%) Follicular Cell, Vacuolization Cytoplasmic 3 (6%) 1 (2%) 19 (66%) 49 (98%) 49 (98%) 44 (90%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 3 NTP Experiment-Test: 05076-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC ETHYLENETHIOUREA Date: 09/10/94 Route: DOSED FEED Time: 02:00:00 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0 PPM 0 PPM 100 PPM 333 PPM 333 PPM 333 PPM 0-0 10-0 1-1 0-3 3-3 10-3 ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Clitoral Gland (1) (1) Dilatation 1 (100%) 1 (100%) Ovary (49) (26) (20) (15) (24) (25) Angiectasis 2 (10%) Hemorrhage 1 (4%) Inflammation, Suppurative 1 (2%) 2 (8%) Thrombosis 1 (5%) Follicle, Cyst 16 (33%) 8 (31%) 8 (40%) 6 (40%) 11 (46%) 8 (32%) Periovarian Tissue, Cyst 3 (6%) 9 (35%) 2 (13%) 3 (13%) 4 (16%) Uterus (48) (33) (13) (19) (20) (20) Angiectasis 2 (10%) Dilatation 2 (4%) 2 (10%) Endometrium, Hyperplasia, Cystic, Glandular 39 (81%) 28 (85%) 7 (54%) 13 (68%) 8 (40%) 9 (45%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (49) (13) (8) (8) (16) (13) Angiectasis 1 (13%) Femoral, Hyperplasia, Neutrophil 1 (8%) Femoral, Necrosis, Acute 1 (8%) Lymph Node (49) (18) (15) (19) (25) (19) Lumbar, Sinus, Lymphatic, Ectasia 1 (2%) Mandibular, Angiectasis 1 (6%) Mandibular, Hyperplasia, Lymphoid 2 (4%) 1 (6%) 1 (5%) Mandibular, Hyperplasia, Reticulum Cell 1 (5%) Mandibular, Infiltration Cellular, Plasma Cell 1 (2%) Mediastinal, Hyperplasia, Lymphoid 1 (2%) Lymph Node, Mesenteric (14) (10) (8) (12) (14) (9) Hematopoietic Cell Proliferation 2 (14%) 1 (10%) 2 (25%) 2 (17%) 1 (7%) 1 (11%) Hemorrhage 1 (7%) Hyperplasia, Lymphoid 1 (7%) Inflammation, Chronic Active 1 (11%) Spleen (50) (23) (13) (28) (31) (34) Fibrosis 1 (2%) 1 (3%) Hematopoietic Cell Proliferation 5 (10%) 3 (13%) 6 (21%) 6 (19%) 5 (15%) Hyperplasia, Lymphoid 3 (6%) 1 (4%) 2 (7%) 3 (10%) 3 (9%) Necrosis, Acute 1 (3%) Thymus (39) (7) (4) (6) (12) (5) a Number of animals examined microscopically at site and number of animals with lesion Page 4 NTP Experiment-Test: 05076-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC ETHYLENETHIOUREA Date: 09/10/94 Route: DOSED FEED Time: 02:00:00 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0 PPM 0 PPM 100 PPM 333 PPM 333 PPM 333 PPM 0-0 10-0 1-1 0-3 3-3 10-3 ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - CONT Depletion Lymphoid 1 (8%) 1 (20%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (35) (13) (8) (8) (16) (11) Hyperplasia, Cystic 1 (3%) Skin (50) (13) (8) (8) (16) (15) Acanthosis 5 (10%) 4 (50%) 8 (50%) Parasite External 6 (12%) 6 (75%) 11 (69%) 1 (7%) Ulcer 1 (2%) Subcutaneous Tissue, Fibrosis 1 (2%) Subcutaneous Tissue, Inflammation, Chronic Active 1 (6%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (50) (13) (9) (9) (16) (14) Tarsal, Hyperostosis 2 (22%) 1 (11%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (13) (8) (8) (16) (14) Compression 2 (4%) 1 (8%) 1 (13%) Hemorrhage 2 (4%) 1 (13%) Hydrocephalus 2 (4%) Perivascular, Inflammation, Chronic Active 1 (2%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (50) (29) (50) (50) (50) Alveolar Epithelium, Hyperplasia 1 (2%) 1 (2%) 1 (2%) 1 (2%) Artery, Embolus 1 (2%) Interstitium, Inflammation, Acute 1 (2%) Mediastinum, Hyperplasia, Lymphoid 1 (2%) Peribronchiolar, Inflammation, Chronic Active 13 (26%) 5 (10%) 2 (7%) 7 (14%) 1 (2%) 2 (4%) Nose (47) (12) (8) (8) (16) (13) Nasolacrimal Duct, Inflammation, Acute 1 (8%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 5 NTP Experiment-Test: 05076-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC ETHYLENETHIOUREA Date: 09/10/94 Route: DOSED FEED Time: 02:00:00 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0 PPM 0 PPM 100 PPM 333 PPM 333 PPM 333 PPM 0-0 10-0 1-1 0-3 3-3 10-3 ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (2) (2) (1) Atrophy 1 (50%) 2 (100%) 1 (100%) Lens, Cataract 1 (50%) Retina, Degeneration 1 (50%) Harderian Gland (3) (3) (1) (4) (1) (1) Inflammation, Chronic Active 1 (100%) Lacrimal Gland (1) Inflammation, Chronic Active 1 (100%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (12) (8) (11) (16) (15) Hemorrhage 1 (13%) Infarct 1 (2%) Nephropathy, Chronic 1 (13%) 1 (9%) Glomerulus, Dilatation 1 (8%) Glomerulus, Inflammation, Acute 1 (7%) Glomerulus, Inflammation, Chronic 1 (7%) Pelvis, Inflammation, Suppurative 1 (2%) Renal Tubule, Cyst 1 (2%) Renal Tubule, Dilatation 1 (6%) Urinary Bladder (48) (12) (8) (9) (13) (11) Inflammation, Acute 1 (2%) Inflammation, Chronic Active 1 (8%) a Number of animals examined microscopically at site and number of animals with lesion Page 6 NTP Experiment-Test: 05076-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC ETHYLENETHIOUREA Date: 09/10/94 Route: DOSED FEED Time: 02:00:00 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 1000 PPM 1000 PPM 0-10 10-10 ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 50 50 Early Deaths Natural Death 9 7 Moribund Sacrifice 10 14 Survivors Natural Death 1 Terminal Sacrifice 30 29 Animals Examined Microscopically 50 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Cecum (50) (48) Inflammation, Chronic Active 1 (2%) Intestine Large, Colon (50) (49) Parasite Metazoan 3 (6%) Liver (50) (50) Angiectasis 1 (2%) Eosinophilic Focus 3 (6%) 2 (4%) Hematopoietic Cell Proliferation 1 (2%) 2 (4%) Hyperplasia, Lymphoid 1 (2%) Infarct 13 (26%) 22 (44%) Infiltration Cellular, Multifocal, Histiocyte 1 (2%) Inflammation, Chronic Active 1 (2%) Mixed Cell Focus 1 (2%) Centrilobular, Cytomegaly 8 (16%) Centrilobular, Vacuolization Cytoplasmic 1 (2%) Mesentery (2) (1) Inflammation, Chronic Active 1 (100%) Pancreas (50) (50) Acinus, Atrophy 1 (2%) 1 (2%) Duct, Ectasia 1 (2%) 1 (2%) Perivascular, Inflammation, Chronic Active 1 (2%) Salivary Glands (49) (50) Hyperplasia, Lymphoid 1 (2%) Perivascular, Inflammation, Chronic Active, Multifocal 1 (2%) Stomach, Forestomach (49) (50) Acanthosis 1 (2%) 1 (2%) Diverticulum 1 (2%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 7 NTP Experiment-Test: 05076-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC ETHYLENETHIOUREA Date: 09/10/94 Route: DOSED FEED Time: 02:00:00 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 1000 PPM 1000 PPM 0-10 10-10 ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (50) (50) Degeneration, Chronic 1 (2%) Inflammation, Chronic 1 (2%) Mineralization 1 (2%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Gland, Cortex (49) (50) Accessory Adrenal Cortical Nodule 1 (2%) Hematopoietic Cell Proliferation 1 (2%) Hypertrophy 1 (2%) 1 (2%) Adrenal Gland, Medulla (50) (50) Hemorrhage, Chronic 1 (2%) Hyperplasia 1 (2%) Pituitary Gland (49) (47) Pars Distalis, Cyst 1 (2%) Pars Distalis, Hyperplasia 27 (55%) 28 (60%) Pars Distalis, Vacuolization Cytoplasmic 2 (4%) Thyroid Gland (50) (50) Follicular Cell, Hyperplasia 46 (92%) 46 (92%) Follicular Cell, Vacuolization Cytoplasmic 47 (94%) 48 (96%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Ovary (50) (48) Hyperplasia, Tubular 1 (2%) Inflammation, Suppurative 1 (2%) Follicle, Cyst 8 (16%) 7 (15%) Periovarian Tissue, Cyst 2 (4%) 2 (4%) Periovarian Tissue, Hyperplasia, Lymphoid 1 (2%) Uterus (48) (48) Angiectasis 2 (4%) Dilatation 2 (4%) 5 (10%) Hyperplasia, Lymphoid 1 (2%) Inflammation, Chronic Active 2 (4%) Endometrium, Hyperplasia, Cystic, Glandular 8 (17%) 11 (23%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 8 NTP Experiment-Test: 05076-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC ETHYLENETHIOUREA Date: 09/10/94 Route: DOSED FEED Time: 02:00:00 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 1000 PPM 1000 PPM 0-10 10-10 ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (49) (49) Femoral, Hyperplasia, Neutrophil 1 (2%) 1 (2%) Femoral, Hyperplasia, Reticulum Cell 1 (2%) Lymph Node (47) (49) Mandibular, Hyperplasia 1 (2%) Mandibular, Hyperplasia, Lymphoid 4 (9%) 2 (4%) Mediastinal, Hyperplasia, Lymphoid 1 (2%) 3 (6%) Lymph Node, Mesenteric (4) (9) Inflammation, Chronic Active 1 (25%) Spleen (49) (50) Hematopoietic Cell Proliferation 1 (2%) Hyperplasia, Lymphoid 6 (12%) 2 (4%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Skin (49) (50) Acanthosis 17 (35%) 7 (14%) Cyst Epithelial Inclusion 1 (2%) Parasite External 22 (45%) 7 (14%) Lip, Inflammation, Chronic 1 (2%) Subcutaneous Tissue, Inflammation, Chronic Active 2 (4%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM None ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (50) Compression 2 (4%) 2 (4%) Hydrocephalus 2 (4%) Perivascular, Inflammation, Chronic Active 1 (2%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (50) Hyperplasia, Lymphoid 5 (10%) 2 (4%) Alveolar Epithelium, Hyperplasia 1 (2%) 1 (2%) Peribronchiolar, Inflammation, Chronic Active 9 (18%) 6 (12%) Nose (49) (50) Mucosa, Inflammation, Acute 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 9 NTP Experiment-Test: 05076-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC ETHYLENETHIOUREA Date: 09/10/94 Route: DOSED FEED Time: 02:00:00 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 1000 PPM 1000 PPM 0-10 10-10 ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (1) (2) Atrophy 1 (100%) 2 (100%) Harderian Gland (4) (3) Inflammation, Chronic Active 1 (25%) Acinus, Dilatation 2 (50%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (50) Hyperplasia, Lymphoid 2 (4%) Nephropathy, Chronic 1 (2%) 1 (2%) Urinary Bladder (49) (49) Hyperplasia, Lymphoid 4 (8%) a Number of animals examined microscopically at site and number of animals with lesion Page 10 NTP Experiment-Test: 05076-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC ETHYLENETHIOUREA Date: 09/10/94 Route: DOSED FEED Time: 02:00:00 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0 PPM 0 PPM 100 PPM 333 PPM 333 PPM 333 PPM 0-0 10-0 1-1 0-3 3-3 10-3 ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 50 50 34 50 50 50 Early Deaths Moribund Sacrifice 8 7 5 8 10 5 Natural Death 11 10 2 10 8 13 Accidently Killed 5 Survivors Moribund Sacrifice 1 Natural Death 1 1 1 Terminal Sacrifice 30 27 25 31 32 30 Missing 1 1 1 Animals Examined Microscopically 50 49 33 50 50 49 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Gallbladder (40) (12) (6) (10) (13) (11) Inflammation, Chronic Active 1 (3%) Intestine Large, Cecum (45) (19) (7) (17) (14) (13) Inflammation, Acute 1 (7%) Parasite Metazoan 1 (14%) Intestine Large, Colon (50) (21) (8) (17) (16) (16) Parasite Metazoan 5 (10%) 3 (18%) 1 (6%) Intestine Large, Rectum (48) (19) (8) (17) (15) (16) Parasite Metazoan 1 (7%) Intestine Small, Ileum (44) (18) (7) (16) (14) (13) Parasite Metazoan 1 (14%) Intestine Small, Jejunum (45) (20) (10) (18) (16) (18) Inflammation, Chronic Active 1 (2%) Liver (49) (49) (33) (50) (47) (49) Basophilic Focus 3 (6%) 5 (10%) 3 (9%) 5 (10%) 4 (9%) 3 (6%) Clear Cell Focus 1 (2%) 1 (3%) 3 (6%) 1 (2%) 5 (10%) Eosinophilic Focus 2 (4%) 8 (16%) 3 (6%) 3 (6%) Fatty Change, Focal 1 (2%) Fibrosis 1 (2%) Hematopoietic Cell Proliferation 3 (6%) 1 (2%) 3 (6%) 4 (8%) Infarct 14 (29%) 4 (8%) 2 (6%) 7 (14%) 3 (6%) 2 (4%) Inflammation, Chronic Active 5 (10%) 1 (2%) 1 (2%) Mixed Cell Focus 2 (4%) Necrosis 2 (4%) Bile Duct, Cyst 3 (6%) 2 (4%) Bile Duct, Hyperplasia 2 (4%) Central Vein, Thrombosis 1 (2%) 1 (2%) Centrilobular, Cytomegaly 1 (2%) 6 (18%) 36 (72%) 33 (70%) 29 (59%) Centrilobular, Necrosis 1 (2%) Centrilobular, Necrosis, Acute 1 (3%) 2 (4%) a Number of animals examined microscopically at site and number of animals with lesion Page 11 NTP Experiment-Test: 05076-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC ETHYLENETHIOUREA Date: 09/10/94 Route: DOSED FEED Time: 02:00:00 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0 PPM 0 PPM 100 PPM 333 PPM 333 PPM 333 PPM 0-0 10-0 1-1 0-3 3-3 10-3 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Mesentery (6) (1) (1) (1) Angiectasis 1 (17%) Inflammation, Chronic Active 2 (33%) 1 (100%) Pancreas (48) (20) (7) (17) (15) (17) Inflammation, Chronic Active 1 (7%) Acinus, Atrophy 5 (10%) 1 (7%) Acinus, Focal Cellular Change 1 (2%) Acinus, Inflammation, Chronic Active 1 (6%) 1 (6%) Duct, Cyst 1 (2%) 1 (6%) Salivary Glands (50) (21) (8) (19) (15) (17) Inflammation, Acute 1 (2%) Acinus, Atrophy 1 (2%) Stomach, Forestomach (49) (24) (7) (17) (16) (22) Acanthosis 1 (2%) 1 (4%) 1 (6%) 1 (5%) Cyst Epithelial Inclusion 1 (5%) Inflammation, Acute 1 (2%) Ulcer 1 (5%) Stomach, Glandular (48) (21) (7) (17) (15) (18) Infiltration Cellular, Lymphocyte 1 (14%) Tooth (5) Incisor, Upper, Dysplasia 3 (60%) Peridontal Tissue, Infiltration Cellular, Mast Cell 1 (20%) Peridontal Tissue, Inflammation, Suppurative 1 (20%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (50) (23) (8) (19) (15) (19) Bacterium, Acute, Multiple 1 (2%) Degeneration, Chronic 1 (13%) Mineralization 1 (2%) Thrombosis 1 (4%) Valve, Inflammation, Suppurative 1 (2%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Gland (50) (21) (8) (18) (15) (18) Corticomedullary Junction, Cyst 1 (2%) Adrenal Gland, Cortex (50) (21) (8) (18) (15) (18) Hyperplasia 6 (12%) 1 (6%) Hypertrophy 8 (16%) 1 (13%) 1 (6%) Adrenal Gland, Medulla (50) (21) (8) (18) (15) (18) Hyperplasia 3 (6%) Pituitary Gland (44) (42) (28) (42) (41) (45) Ectasia 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 12 NTP Experiment-Test: 05076-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC ETHYLENETHIOUREA Date: 09/10/94 Route: DOSED FEED Time: 02:00:00 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0 PPM 0 PPM 100 PPM 333 PPM 333 PPM 333 PPM 0-0 10-0 1-1 0-3 3-3 10-3 ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM - CONT Craniopharyngeal Duct, Inflammation, Chronic Active 1 (2%) Pars Distalis, Cyst 2 (5%) 1 (4%) 1 (2%) 1 (2%) Pars Distalis, Hyperplasia 1 (4%) 2 (5%) 2 (5%) 1 (2%) Thyroid Gland (50) (46) (33) (49) (47) (48) Artery, Inflammation, Chronic Active 1 (2%) Follicular Cell, Hyperplasia 2 (4%) 1 (3%) 3 (6%) 7 (15%) Follicular Cell, Vacuolization Cytoplasmic 25 (76%) 46 (94%) 43 (91%) 46 (96%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Epididymis (49) (22) (8) (18) (15) (19) Inflammation, Acute 1 (6%) Inflammation, Chronic Active 2 (11%) Preputial Gland (2) (2) (1) (2) (4) (3) Inflammation, Chronic Active 1 (50%) 1 (100%) 2 (100%) 2 (50%) 2 (67%) Inflammation, Suppurative 1 (50%) 1 (50%) Duct, Dilatation 1 (50%) 2 (100%) 2 (50%) 2 (67%) Prostate (50) (22) (8) (18) (15) (19) Inflammation, Chronic Active 2 (11%) 1 (7%) 3 (16%) Inflammation, Suppurative 3 (6%) 3 (14%) 2 (11%) Seminal Vesicle (4) (2) (1) (1) (1) Dilatation 2 (50%) 2 (100%) 1 (100%) 1 (100%) 1 (100%) Inflammation, Suppurative 1 (25%) Testes (50) (22) (8) (20) (14) (19) Seminiferous Tubule, Degeneration 1 (2%) 1 (5%) 2 (10%) Seminiferous Tubule, Mineralization 1 (5%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (49) (21) (8) (18) (13) (19) Femoral, Hyperplasia, Neutrophil 1 (2%) 1 (5%) 1 (6%) 2 (11%) Lymph Node (48) (25) (15) (22) (20) (22) Lumbar, Hyperplasia, Lymphoid 1 (4%) Mandibular, Hyperplasia, Lymphoid 2 (9%) 1 (5%) Mandibular, Infiltration Cellular, Histiocyte 1 (4%) 1 (7%) Lymph Node, Mesenteric (14) (11) (7) (4) (8) (6) Hematopoietic Cell Proliferation 11 (79%) 7 (64%) 1 (14%) 2 (50%) 3 (38%) Hemorrhage 1 (17%) Hyperplasia, Lymphoid 2 (18%) 1 (14%) a Number of animals examined microscopically at site and number of animals with lesion Page 13 NTP Experiment-Test: 05076-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC ETHYLENETHIOUREA Date: 09/10/94 Route: DOSED FEED Time: 02:00:00 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0 PPM 0 PPM 100 PPM 333 PPM 333 PPM 333 PPM 0-0 10-0 1-1 0-3 3-3 10-3 ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - CONT Infiltration Cellular, Plasma Cell 1 (14%) Inflammation, Chronic Active 1 (13%) 1 (17%) Thrombosis 1 (7%) Spleen (49) (25) (12) (21) (24) (24) Depletion Lymphoid 4 (8%) 1 (4%) 2 (8%) Hematopoietic Cell Proliferation 3 (6%) 2 (8%) 2 (17%) 4 (19%) 5 (21%) 8 (33%) Hyperplasia, Lymphoid 1 (4%) 1 (5%) 1 (4%) 1 (4%) Thymus (29) (11) (4) (11) (11) (11) Depletion Lymphoid 1 (9%) 1 (9%) 2 (18%) 1 (9%) Necrosis, Diffuse 1 (3%) 1 (9%) 1 (9%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Skin (50) (26) (14) (23) (25) (26) Acanthosis 3 (12%) 4 (29%) 4 (17%) 3 (12%) 2 (8%) Alopecia 1 (7%) Hyperplasia, Basal Cell 1 (7%) Parasite External 1 (2%) 4 (15%) 6 (43%) 5 (22%) 4 (16%) 5 (19%) Ulcer 1 (2%) 3 (12%) 3 (13%) 5 (20%) 3 (12%) Prepuce, Inflammation, Acute 1 (4%) Prepuce, Subcutaneous Tissue, Foreign Body 1 (4%) Subcutaneous Tissue, Edema 1 (4%) Subcutaneous Tissue, Fibrosis 1 (2%) 1 (4%) 1 (7%) 2 (9%) 1 (4%) 1 (4%) Subcutaneous Tissue, Granuloma 1 (7%) Subcutaneous Tissue, Inflammation, Acute 1 (2%) 1 (4%) Subcutaneous Tissue, Inflammation, Chronic Active 2 (8%) 1 (4%) 2 (8%) Subcutaneous Tissue, Metaplasia, Osseous 1 (4%) Subcutaneous Tissue, Sebaceous Gland, Hyperplasia 1 (4%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (50) (44) (25) (42) (39) (38) Femur, Hyperostosis 1 (2%) Tarsal, Hyperostosis 22 (44%) 24 (55%) 18 (72%) 28 (67%) 29 (74%) 29 (76%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (21) (8) (19) (15) (19) Infarct 1 (2%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 14 NTP Experiment-Test: 05076-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC ETHYLENETHIOUREA Date: 09/10/94 Route: DOSED FEED Time: 02:00:00 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0 PPM 0 PPM 100 PPM 333 PPM 333 PPM 333 PPM 0-0 10-0 1-1 0-3 3-3 10-3 ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (49) (33) (50) (47) (49) Inflammation, Chronic, Diffuse 1 (2%) Metaplasia, Squamous 1 (2%) Alveolar Epithelium, Hyperplasia 2 (4%) 2 (4%) 3 (9%) 2 (4%) 5 (11%) 3 (6%) Alveolus, Hyperplasia, Macrophage 1 (2%) 1 (2%) Artery, Embolus 1 (2%) Mediastinum, Inflammation 1 (3%) Peribronchial, Inflammation, Chronic Active 2 (4%) 1 (2%) Peribronchiolar, Inflammation, Chronic Active 26 (52%) 6 (12%) 5 (15%) 17 (34%) 16 (34%) 7 (14%) Perivascular, Inflammation, Chronic Active 2 (4%) 1 (2%) Nose (50) (21) (8) (19) (16) (18) Mucosa, Inflammation, Acute 2 (4%) 1 (6%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (2) (1) Atrophy 1 (100%) Cornea, Inflammation, Chronic Active 1 (50%) Harderian Gland (4) (1) (3) (3) (1) (3) Hyperplasia 1 (25%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (49) (23) (11) (21) (17) (19) Hydronephrosis 1 (2%) 2 (9%) Inflammation, Chronic Active 1 (4%) Metaplasia, Osseous 1 (2%) Nephropathy, Chronic 32 (65%) 3 (13%) 3 (14%) 2 (11%) Capsule, Fibrosis, Focal 1 (4%) 1 (9%) Cortex, Cyst 2 (18%) 1 (6%) Cortex, Infiltration Cellular, Focal, Histiocyte 1 (6%) Pelvis, Bacterium 1 (2%) Pelvis, Inflammation, Suppurative 2 (4%) 1 (5%) Renal Tubule, Mineralization 1 (5%) Renal Tubule, Necrosis 1 (2%) 1 (4%) Urethra (2) (2) (1) Inflammation, Chronic Active 1 (100%) Inflammation, Suppurative 2 (100%) 1 (50%) Bulbourethral Gland, Dilatation 1 (50%) Urinary Bladder (49) (20) (8) (17) (15) (16) Calculus Gross Observation 2 (10%) Dilatation 2 (4%) 3 (15%) 2 (25%) 2 (12%) 2 (13%) Inflammation, Chronic Active 3 (6%) 2 (10%) 1 (6%) a Number of animals examined microscopically at site and number of animals with lesion Page 15 NTP Experiment-Test: 05076-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC ETHYLENETHIOUREA Date: 09/10/94 Route: DOSED FEED Time: 02:00:00 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0 PPM 0 PPM 100 PPM 333 PPM 333 PPM 333 PPM 0-0 10-0 1-1 0-3 3-3 10-3 ____________________________________________________________________________________________________________________________________ URINARY SYSTEM - CONT Mineralization 2 (4%) Mucosa, Hyperplasia 1 (6%) a Number of animals examined microscopically at site and number of animals with lesion Page 16 NTP Experiment-Test: 05076-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC ETHYLENETHIOUREA Date: 09/10/94 Route: DOSED FEED Time: 02:00:00 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 1000 PPM 1000 PPM 0-10 10-10 ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 50 50 Early Deaths Moribund Sacrifice 14 10 Natural Death 13 15 Survivors Terminal Sacrifice 22 24 Natural Death 1 1 Animals Examined Microscopically 50 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Gallbladder (33) (27) Epithelium, Hypertrophy, Focal 1 (4%) Intestine Large, Cecum (42) (40) Parasite Metazoan 3 (8%) Intestine Large, Colon (49) (45) Inflammation, Acute, Necrotizing 1 (2%) Parasite Metazoan 8 (16%) 9 (20%) Intestine Large, Rectum (46) (41) Parasite Metazoan 4 (9%) 4 (10%) Intestine Small, Ileum (43) (40) Parasite Metazoan 4 (9%) 1 (3%) Intestine Small, Jejunum (44) (40) Inflammation, Chronic Active 1 (2%) Lymphatic, Ectasia 1 (3%) Liver (50) (49) Basophilic Focus 1 (2%) Eosinophilic Focus 2 (4%) 11 (22%) Hematopoietic Cell Proliferation 1 (2%) Infarct 33 (66%) 34 (69%) Centrilobular, Cytomegaly 25 (50%) 40 (82%) Oval Cell, Hyperplasia 2 (4%) Mesentery (5) (3) Angiectasis 1 (20%) Inflammation, Acute, Necrotizing 1 (20%) Inflammation, Chronic Active 1 (20%) Pancreas (45) (47) Acinus, Atrophy 4 (9%) 2 (4%) Duct, Ectasia 1 (2%) Perivascular, Inflammation, Chronic Active 1 (2%) Salivary Glands (50) (49) Acinus, Atrophy 1 (2%) Perivascular, Inflammation, Suppurative 1 (2%) Stomach, Forestomach (49) (45) a Number of animals examined microscopically at site and number of animals with lesion Page 17 NTP Experiment-Test: 05076-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC ETHYLENETHIOUREA Date: 09/10/94 Route: DOSED FEED Time: 02:00:00 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 1000 PPM 1000 PPM 0-10 10-10 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Acanthosis 1 (2%) Inflammation, Acute 1 (2%) Stomach, Glandular (48) (44) Dysplasia 1 (2%) Infiltration Cellular, Mast Cell 1 (2%) Inflammation, Acute 1 (2%) Inflammation, Chronic 2 (4%) Tooth (4) (1) Incisor, Upper, Dysplasia 1 (25%) Peridontal Tissue, Inflammation, Suppurative 2 (50%) 1 (100%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (50) (50) Bacterium, Acute, Multiple 1 (2%) Degeneration, Chronic 1 (2%) Mineralization 1 (2%) Thrombosis 1 (2%) Artery, Inflammation, Chronic Active 1 (2%) Valve, Bacterium 1 (2%) Valve, Inflammation, Suppurative 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Gland, Cortex (50) (49) Hyperplasia 3 (6%) 3 (6%) Hypertrophy 10 (20%) 7 (14%) Adrenal Gland, Medulla (50) (49) Hyperplasia 2 (4%) 4 (8%) Pituitary Gland (41) (39) Pars Distalis, Hyperplasia 32 (78%) 25 (64%) Thyroid Gland (50) (49) Follicular Cell, Hyperplasia 44 (88%) 47 (96%) Follicular Cell, Vacuolization Cytoplasmic 47 (94%) 46 (94%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 18 NTP Experiment-Test: 05076-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC ETHYLENETHIOUREA Date: 09/10/94 Route: DOSED FEED Time: 02:00:00 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 1000 PPM 1000 PPM 0-10 10-10 ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Epididymis (49) (49) Inflammation, Chronic Active 1 (2%) Arteriole, Inflammation, Chronic Active 1 (2%) Preputial Gland (2) (1) Inflammation, Chronic Active 1 (50%) Inflammation, Suppurative 1 (50%) Duct, Dilatation 1 (50%) 1 (100%) Prostate (47) (49) Inflammation, Suppurative 1 (2%) 2 (4%) Arteriole, Inflammation, Chronic Active 1 (2%) Seminal Vesicle (2) Dilatation 1 (50%) Testes (50) (49) Arteriole, Inflammation, Chronic Active 1 (2%) Seminiferous Tubule, Degeneration 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (49) (47) Femoral, Hyperplasia, Neutrophil 1 (2%) Lymph Node (47) (48) Lumbar, Necrosis 1 (2%) Pancreatic, Necrosis 1 (2%) Lymph Node, Mesenteric (7) (5) Hematopoietic Cell Proliferation 3 (43%) 2 (40%) Spleen (48) (47) Hematopoietic Cell Proliferation 3 (6%) 1 (2%) Thymus (16) (16) Necrosis, Diffuse 2 (13%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Skin (49) (50) Acanthosis 1 (2%) Parasite External 28 (57%) 6 (12%) Subcutaneous Tissue, Edema 1 (2%) Subcutaneous Tissue, Fibrosis 1 (2%) 1 (2%) Subcutaneous Tissue, Inflammation, Chronic Active 5 (10%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 19 NTP Experiment-Test: 05076-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC ETHYLENETHIOUREA Date: 09/10/94 Route: DOSED FEED Time: 02:00:00 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 1000 PPM 1000 PPM 0-10 10-10 ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (50) (50) Tarsal, Hyperostosis 15 (30%) 24 (48%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (49) Infarct 1 (2%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (49) Inflammation, Chronic, Diffuse 1 (2%) Alveolar Epithelium, Hyperplasia 2 (4%) 4 (8%) Alveolus, Hyperplasia, Macrophage 1 (2%) Arteriole, Capillary, Inflammation, Suppurative 1 (2%) Artery, Mediastinum, Inflammation, Suppurative 1 (2%) Peribronchiolar, Inflammation, Acute, Necrotizing 1 (2%) Peribronchiolar, Inflammation, Chronic Active 21 (42%) 18 (37%) Perivascular, Inflammation, Chronic Active 1 (2%) Nose (50) (49) Mucosa, Inflammation, Acute 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (6) (2) Atrophy 5 (83%) 2 (100%) Inflammation 1 (17%) Inflammation, Suppurative 1 (17%) Harderian Gland (18) (6) Inflammation, Chronic Active 10 (56%) 2 (33%) Inflammation, Suppurative 5 (28%) 1 (17%) Necrosis 1 (17%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (49) Infarct 1 (2%) Nephropathy, Chronic 22 (44%) 17 (35%) Pelvis, Inflammation, Suppurative 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 20 NTP Experiment-Test: 05076-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC ETHYLENETHIOUREA Date: 09/10/94 Route: DOSED FEED Time: 02:00:00 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 1000 PPM 1000 PPM 0-10 10-10 ____________________________________________________________________________________________________________________________________ URINARY SYSTEM - CONT Renal Tubule, Necrosis 1 (2%) 1 (2%) Urethra (3) (1) Inflammation, Suppurative 3 (100%) 1 (100%) Urinary Bladder (48) (48) Inflammation, Chronic Active 1 (2%) Arteriole, Inflammation, Chronic Active 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 21 ------------------------------------------------------------ ---------- END OF REPORT ---------- 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