TDMS Study 05025-01 Pathology Tables
INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) ETHYLENE GLYCOL NTP Experiment-Test: 05025-01 Report: PEIRPT03 Study Type: CHRONIC Date: 09/04/94 Route: DOSED FEED Time: 06:04:38 Facility: Southern Research Institute Chemical CAS #: 107-21-1 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: 05025-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC ETHYLENE GLYCOL Date: 09/04/94 Route: DOSED FEED Time: 06:04:38 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE UNTREATD 1.25% 2.5% 5.0% CONTROL ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 60 60 60 60 Scheduled Sacrifice 10 10 9 10 Early Deaths Moribund 9 9 12 12 Dead 8 11 9 1 Survivors Terminal Sacrifice 33 30 30 37 Animals Examined Microscopically 50 50 51 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Gallbladder (48) (18) (21) (49) Inflammation 1 (2%) Intestine Large, Cecum (48) (19) (16) (50) Edema 1 (2%) Lymphoid Tissue, Hyperplasia, Lymphoid 1 (2%) Intestine Large, Colon (49) (19) (19) (50) Inflammation, Suppurative 1 (2%) Intestine Large, Rectum (49) (19) (17) (50) Edema 1 (2%) Intestine Small, Ileum (47) (19) (16) (50) Amyloid Deposition 2 (4%) Dilatation 1 (6%) Inflammation, Chronic 1 (6%) Lymphoid Tissue, Hyperplasia, Lymphoid 2 (4%) Lymphoid Tissue, Inflammation, Granulomatous 1 (2%) Intestine Small, Jejunum (47) (19) (16) (50) Amyloid Deposition 1 (5%) 1 (2%) Dilatation 1 (6%) Liver (50) (50) (51) (50) Angiectasis 1 (2%) Basophilic Focus 1 (2%) 1 (2%) Congestion 1 (2%) 1 (2%) Cyst 1 (2%) Fatty Change 2 (4%) 3 (6%) Fibrosis 1 (2%) Hematopoietic Cell Proliferation 2 (4%) 6 (12%) 7 (14%) 2 (4%) Hyperplasia, Lymphoid 14 (28%) 14 (28%) 16 (31%) 12 (24%) Infarct 1 (2%) 1 (2%) 1 (2%) 1 (2%) Infiltration Cellular, Mixed Cell 4 (8%) 10 (20%) 11 (22%) 4 (8%) Inflammation, Multifocal 17 (34%) 10 (20%) 19 (37%) 24 (48%) Mineralization 1 (2%) Necrosis, Multifocal 2 (4%) 2 (4%) 1 (2%) 2 (4%) a Number of animals examined microscopically at site and number of animals with lesion Page 2 NTP Experiment-Test: 05025-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC ETHYLENE GLYCOL Date: 09/04/94 Route: DOSED FEED Time: 06:04:38 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE UNTREATD 1.25% 2.5% 5.0% CONTROL ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Pigmentation 1 (2%) Bile Duct, Hyperplasia 1 (2%) Hepatocyte, Erythrophagocytosis 2 (4%) Hepatocyte, Centrilobular, Degeneration, Hyaline 1 (2%) 26 (52%) Portal Vein, Media, Hyperplasia 1 (2%) Mesentery (17) (7) (15) (7) Cyst 1 (7%) Edema 1 (14%) Hemorrhage 1 (6%) Inflammation, Suppurative 6 (35%) 5 (71%) 9 (60%) 2 (29%) Fat, Necrosis 8 (47%) 1 (14%) Pancreas (49) (21) (22) (50) Atrophy, Diffuse 2 (10%) Atrophy, Focal 1 (5%) 3 (6%) Ectopic Tissue 1 (2%) Hyperplasia, Lymphoid 2 (4%) Inflammation, Suppurative 1 (5%) 1 (5%) Acinar Cell, Hypoplasia, Focal 1 (2%) Duct, Dilatation 1 (2%) 1 (5%) 1 (5%) 3 (6%) Duct, Dilatation, Multiple 1 (2%) Salivary Glands (49) (20) (21) (50) Hyperplasia, Focal 1 (2%) Stomach, Forestomach (50) (20) (20) (50) Inflammation, Focal 1 (5%) 2 (4%) Mineralization 1 (2%) 1 (2%) Mucosa, Hyperplasia, Papillary 1 (2%) Stomach, Glandular (49) (20) (20) (50) Hyperplasia, Lymphoid 2 (4%) 1 (2%) Inflammation, Focal 1 (2%) 4 (8%) Mineralization 1 (2%) 3 (6%) Epithelium, Degeneration, Hyaline 2 (4%) Epithelium, Metaplasia, Squamous 1 (2%) Mucosa, Cyst 2 (4%) Tooth (2) (4) (1) (3) Incisor, Dysplasia 2 (100%) 4 (100%) 1 (100%) 3 (100%) Incisor, Inflammation, Suppurative 1 (25%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Blood Vessel (2) (1) Aorta, Thrombosis 1 (50%) Mesenteric Artery, Inflammation, Chronic 1 (50%) 1 (100%) Heart (50) (20) (21) (50) Infiltration Cellular, Mixed Cell 1 (5%) Inflammation, Suppurative 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 3 NTP Experiment-Test: 05025-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC ETHYLENE GLYCOL Date: 09/04/94 Route: DOSED FEED Time: 06:04:38 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE UNTREATD 1.25% 2.5% 5.0% CONTROL ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM - CONT Artery, Media, Hyperplasia 1 (2%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Gland, Cortex (49) (21) (21) (50) Accessory Adrenal Cortical Nodule 1 (2%) Amyloid Deposition 1 (2%) Angiectasis 1 (2%) Focal Cellular Change 1 (5%) Hematopoietic Cell Proliferation 1 (5%) Hemorrhage, Focal 1 (2%) Hyperplasia, Focal 1 (2%) Infiltration Cellular, Mixed Cell 1 (5%) Inflammation, Suppurative 1 (2%) Vacuolization Cytoplasmic, Focal 2 (4%) Subcapsular, Hyperplasia, Focal 1 (2%) Adrenal Gland, Medulla (48) (21) (21) (50) Ectopic Tissue 2 (4%) Hyperplasia, Focal 1 (2%) 1 (5%) 1 (2%) Parathyroid Gland (49) (18) (14) (42) Cyst 1 (2%) Pituitary Gland (47) (22) (23) (47) Pars Distalis, Angiectasis 1 (2%) Pars Distalis, Bacterium 1 (2%) Pars Distalis, Cyst 2 (4%) Pars Distalis, Focal Cellular Change 2 (9%) 2 (9%) Pars Distalis, Hyperplasia, Focal 13 (28%) 2 (9%) 14 (30%) Pars Distalis, Necrosis, Focal 1 (5%) Pars Nervosa, Inflammation, Focal 1 (4%) Thyroid Gland (49) (50) (51) (50) Degeneration, Cystic 4 (8%) 6 (12%) 4 (8%) 4 (8%) Hyperplasia, Lymphoid 1 (2%) Inflammation, Focal 3 (6%) 3 (6%) 3 (6%) C-Cell, Hyperplasia 1 (2%) 1 (2%) Follicular Cell, Hyperplasia 8 (16%) 16 (32%) 22 (43%) 14 (28%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM Tissue NOS (2) (1) Abdominal, Foreign Body 1 (50%) Abdominal, Infiltration Cellular, Lymphocyte 1 (100%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 4 NTP Experiment-Test: 05025-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC ETHYLENE GLYCOL Date: 09/04/94 Route: DOSED FEED Time: 06:04:38 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE UNTREATD 1.25% 2.5% 5.0% CONTROL ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Ovary (49) (25) (25) (48) Angiectasis 1 (2%) 2 (8%) 3 (6%) Atrophy 2 (4%) Fibrosis, Focal 1 (2%) Granuloma 1 (4%) Hemorrhage 1 (4%) 2 (4%) Hyperplasia, Lymphoid 1 (4%) Inflammation, Chronic 1 (4%) Inflammation, Suppurative 8 (16%) 10 (40%) 9 (36%) 3 (6%) Mineralization 2 (4%) Thrombosis 1 (4%) Follicle, Cyst 11 (22%) 5 (20%) 8 (32%) 9 (19%) Follicle, Cyst, Multiple 1 (4%) Oviduct (3) (4) (1) Hyperplasia, Cystic 1 (100%) Inflammation, Suppurative 2 (67%) 4 (100%) Uterus (50) (45) (45) (50) Angiectasis 4 (9%) 1 (2%) 2 (4%) Hemorrhage 1 (2%) 1 (2%) 2 (4%) Hydrometra 3 (6%) 4 (9%) 2 (4%) 4 (8%) Inflammation, Suppurative 6 (12%) 7 (16%) 5 (11%) 3 (6%) Thrombosis 1 (2%) Endometrium, Cyst 1 (2%) 2 (4%) Endometrium, Hyperplasia, Cystic 44 (88%) 40 (89%) 40 (89%) 47 (94%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (50) (20) (21) (50) Hyperplasia, Neutrophil 1 (2%) 1 (5%) 1 (5%) 2 (4%) Lymph Node (50) (24) (22) (50) Iliac, Hyperplasia 1 (4%) 4 (18%) 1 (2%) Inguinal, Hyperplasia 1 (2%) Inguinal, Hyperplasia, Lymphoid 1 (5%) Mediastinal, Angiectasis 1 (4%) Mediastinal, Hyperplasia 3 (6%) 3 (13%) 3 (14%) 1 (2%) Mediastinal, Hyperplasia, Lymphoid 1 (2%) 2 (8%) 2 (4%) Mediastinal, Inflammation, Suppurative 5 (10%) 1 (4%) 1 (5%) Mesenteric, Angiectasis 4 (8%) 2 (8%) 6 (12%) Mesenteric, Hyperplasia 2 (4%) 1 (4%) 2 (9%) 2 (4%) Mesenteric, Hyperplasia, Lymphoid 5 (10%) 2 (9%) 7 (14%) Mesenteric, Inflammation, Suppurative 2 (4%) Pancreatic, Hyperplasia 1 (5%) Renal, Hyperplasia 2 (4%) 1 (4%) 5 (23%) 1 (2%) Renal, Inflammation, Suppurative 1 (2%) 1 (4%) Lymph Node, Mandibular (43) (21) (20) (49) a Number of animals examined microscopically at site and number of animals with lesion Page 5 NTP Experiment-Test: 05025-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC ETHYLENE GLYCOL Date: 09/04/94 Route: DOSED FEED Time: 06:04:38 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE UNTREATD 1.25% 2.5% 5.0% CONTROL ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - CONT Hyperplasia 1 (2%) 2 (4%) Hyperplasia, Lymphoid 2 (5%) 1 (5%) 1 (5%) 6 (12%) Spleen (49) (29) (28) (50) Depletion Cellular 1 (2%) Fibrosis, Focal 1 (2%) Hematopoietic Cell Proliferation 14 (29%) 12 (41%) 20 (71%) 13 (26%) Hyperplasia, Lymphoid 11 (22%) 2 (7%) 6 (21%) 13 (26%) Thymus (47) (19) (19) (47) Cyst 1 (5%) 1 (2%) Hyperplasia 1 (2%) Hyperplasia, Lymphoid 7 (15%) 1 (5%) 6 (13%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (49) (20) (21) (50) Dilatation 4 (8%) 1 (5%) 6 (12%) Hyperplasia 2 (4%) Inflammation, Suppurative 1 (2%) Duct, Metaplasia, Squamous 1 (2%) Skin (49) (43) (40) (50) Inflammation, Chronic 16 (33%) 5 (12%) 6 (15%) 11 (22%) Subcutaneous Tissue, Edema 1 (2%) Subcutaneous Tissue, Hyperplasia, Lymphoid 1 (2%) Subcutaneous Tissue, Inflammation, Chronic 2 (4%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (50) (20) (21) (50) Cranium, Hyperostosis 1 (2%) Distal, Joint, Femur, Arthrosis 1 (2%) Femur, Hyperostosis 1 (5%) Skeletal Muscle (2) (2) (2) (1) Inflammation, Suppurative 1 (50%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (49) (20) (21) (50) Compression 1 (2%) 1 (5%) 1 (5%) 3 (6%) Gliosis 1 (5%) Hemorrhage, Multifocal 2 (4%) Infiltration Cellular, Lymphocyte 1 (5%) Necrosis, Focal 1 (5%) Artery, Inflammation, Chronic 1 (5%) Artery, Meninges, Inflammation, Chronic 1 (5%) a Number of animals examined microscopically at site and number of animals with lesion Page 6 NTP Experiment-Test: 05025-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC ETHYLENE GLYCOL Date: 09/04/94 Route: DOSED FEED Time: 06:04:38 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE UNTREATD 1.25% 2.5% 5.0% CONTROL ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM - CONT Meninges, Hyperplasia, Lymphoid 1 (2%) Meninges, Infiltration Cellular, Mixed Cell 1 (5%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (50) (51) (50) Bacterium 1 (2%) Congestion 2 (4%) 2 (4%) Hemorrhage 2 (4%) 4 (8%) Hyperplasia, Lymphoid 17 (34%) 16 (32%) 15 (29%) 21 (42%) Hyperplasia, Macrophage 2 (4%) 2 (4%) 1 (2%) Infiltration Cellular, Mixed Cell 3 (6%) 3 (6%) 3 (6%) 1 (2%) Inflammation, Granulomatous 2 (4%) Inflammation, Suppurative 1 (2%) 1 (2%) Mineralization 1 (2%) Pigmentation 1 (2%) Alveolar Epithelium, Hyperplasia 1 (2%) Artery, Inflammation 1 (2%) Artery, Media, Hyperplasia 3 (6%) 10 (20%) 10 (20%) 23 (46%) Bronchiole, Bronchiectasis 1 (2%) Bronchiole, Epithelium, Hyperplasia 1 (2%) Mediastinum, Inflammation, Suppurative 1 (2%) 3 (6%) Vein, Intima, Mineralization 1 (2%) Nose (50) (20) (21) (50) Lumen, Exudate 2 (4%) 1 (2%) Lumen, Foreign Body 1 (2%) 1 (2%) Mucosa, Angiectasis 1 (2%) Mucosa, Hemorrhage 1 (2%) Nasolacrimal Duct, Inflammation, Suppurative 1 (2%) Trachea (49) (20) (21) (50) Artery, Peritracheal Tissue, Inflammation, Chronic 1 (5%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (1) (1) Atrophy 1 (100%) Cataract 1 (100%) Fibrosis 1 (100%) Retinal Detachment 1 (100%) Cornea, Inflammation 1 (100%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 7 NTP Experiment-Test: 05025-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC ETHYLENE GLYCOL Date: 09/04/94 Route: DOSED FEED Time: 06:04:38 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE UNTREATD 1.25% 2.5% 5.0% CONTROL ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (49) (50) (50) (50) Bacterium 1 (2%) 1 (2%) Cyst 1 (2%) Infiltration Cellular, Mixed Cell 1 (2%) 2 (4%) 1 (2%) Inflammation, Chronic 1 (2%) Inflammation, Suppurative 2 (4%) 2 (4%) Metaplasia, Osseous 1 (2%) 1 (2%) 3 (6%) Necrosis, Multifocal 1 (2%) Nephropathy 25 (51%) 20 (40%) 33 (66%) 28 (56%) Capsule, Inflammation, Suppurative 1 (2%) Pelvis, Dilatation 1 (2%) Renal Tubule, Degeneration, Hyaline 3 (6%) 2 (4%) Renal Tubule, Dilatation 1 (2%) 1 (2%) Renal Tubule, Hyperplasia 1 (2%) Renal Tubule, Mineralization 1 (2%) Renal Tubule, Pigmentation 2 (4%) Renal Tubule, Vacuolization Cytoplasmic 1 (2%) Urinary Bladder (49) (19) (21) (50) Hyperplasia, Lymphoid 2 (4%) 5 (10%) Inflammation, Chronic 1 (5%) 1 (2%) Ulcer 1 (2%) Transitional Epithelium, Hyperplasia 1 (5%) Transitional Epithelium, Metaplasia, Squamous 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 8 NTP Experiment-Test: 05025-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC ETHYLENE GLYCOL Date: 09/04/94 Route: DOSED FEED Time: 06:04:38 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE UNTREATD 0.625% 1.25% 2.5% CONTROL ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 60 60 60 60 Scheduled Sacrifice 6 6 6 6 Early Deaths Dead 15 8 11 16 Moribund 10 14 11 15 Survivors Terminal Sacrifice 29 32 32 23 Animals Examined Microscopically 54 54 54 54 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Esophagus (54) (21) (22) (54) Inflammation, Chronic 1 (2%) Gallbladder (51) (19) (16) (48) Inflammation 1 (2%) 1 (6%) Mucosa, Hyperplasia 1 (6%) Intestine Large, Cecum (52) (18) (18) (49) Parasite Metazoan 1 (2%) Intestine Large, Rectum (54) (19) (21) (48) Inflammation, Chronic 1 (2%) Prolapse 1 (5%) Intestine Small, Duodenum (53) (20) (18) (46) Mucosa, Inflammation, Suppurative 1 (2%) Intestine Small, Ileum (53) (17) (17) (45) Perforation 1 (6%) Lymphoid Tissue, Hyperplasia, Lymphoid 1 (2%) Intestine Small, Jejunum (54) (18) (19) (50) Hyperplasia, Lymphoid 1 (2%) Inflammation, Suppurative 1 (2%) Liver (54) (53) (53) (54) Angiectasis 1 (2%) Autolysis 1 (2%) Bacterium 2 (4%) Basophilic Focus 1 (2%) 2 (4%) 2 (4%) Congestion 1 (2%) 1 (2%) Cyst 1 (2%) Eosinophilic Focus 2 (4%) 1 (2%) Fatty Change 2 (4%) Fibrosis 2 (4%) Focal Cellular Change 1 (2%) 1 (2%) Hematopoietic Cell Proliferation 3 (6%) 1 (2%) 1 (2%) Hyperplasia, Lymphoid 2 (4%) 3 (6%) 3 (6%) 2 (4%) Hyperplasia, Multifocal 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 9 NTP Experiment-Test: 05025-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC ETHYLENE GLYCOL Date: 09/04/94 Route: DOSED FEED Time: 06:04:38 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE UNTREATD 0.625% 1.25% 2.5% CONTROL ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Infarct 1 (2%) Infiltration Cellular, Mixed Cell 4 (7%) 5 (9%) 2 (4%) 8 (15%) Inflammation, Multifocal 6 (11%) 11 (21%) 16 (30%) 13 (24%) Necrosis, Multifocal 10 (19%) 6 (11%) 4 (8%) 8 (15%) Pigmentation 1 (2%) 1 (2%) 3 (6%) Artery, Media, Hypertrophy 1 (2%) Bile Duct, Cyst 1 (2%) Bile Duct, Hyperplasia 1 (2%) Centrilobular, Necrosis 1 (2%) 2 (4%) 1 (2%) Centrilobular, Vacuolization Nuclear 1 (2%) Hepatocyte, Cytomegaly 1 (2%) Hepatocyte, Centrilobular, Degeneration, Hyaline 24 (45%) 36 (67%) Mesentery (5) (3) (1) (7) Inflammation, Chronic 2 (67%) 1 (100%) 1 (14%) Inflammation, Granulomatous 1 (14%) Inflammation, Suppurative 1 (20%) 3 (43%) Fat, Necrosis 1 (14%) Pancreas (54) (23) (21) (54) Atrophy, Focal 1 (4%) Fibrosis, Focal 1 (2%) Focal Cellular Change 1 (2%) Inflammation, Chronic, Focal 2 (4%) Necrosis, Focal 1 (2%) Duct, Degeneration, Hyaline 1 (2%) Duct, Dilatation 1 (2%) 1 (5%) Duct, Hyperplasia, Papillary 1 (2%) Duct, Metaplasia 1 (2%) Vein, Infiltration Cellular, Mixed Cell 1 (2%) Salivary Glands (53) (21) (20) (54) Atrophy, Focal 1 (2%) Fibrosis, Focal 1 (2%) Stomach, Forestomach (54) (20) (21) (54) Mineralization 1 (2%) Mucosa, Hyperplasia, Papillary 2 (4%) Mucosa, Ulcer 1 (2%) Stomach, Glandular (54) (20) (21) (54) Erosion 1 (5%) Inflammation, Focal 1 (2%) 1 (5%) 1 (2%) Mineralization 2 (4%) 2 (10%) Epithelium, Metaplasia, Squamous 1 (2%) Epithelium, Vacuolization Cytoplasmic, Multifocal 1 (2%) Mucosa, Cyst 2 (4%) Mucosa, Erosion 1 (2%) Tooth (21) (4) (1) (18) Incisor, Dysplasia 18 (86%) 4 (100%) 1 (100%) 15 (83%) a Number of animals examined microscopically at site and number of animals with lesion Page 10 NTP Experiment-Test: 05025-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC ETHYLENE GLYCOL Date: 09/04/94 Route: DOSED FEED Time: 06:04:38 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE UNTREATD 0.625% 1.25% 2.5% CONTROL ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Incisor, Inflammation, Chronic 1 (5%) Incisor, Inflammation, Suppurative 2 (10%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (54) (21) (22) (54) Inflammation, Chronic 3 (6%) 1 (2%) Inflammation, Focal 1 (2%) Inflammation, Suppurative 1 (2%) 3 (6%) Atrium, Thrombosis, Multiple 1 (2%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Gland, Cortex (54) (20) (21) (54) Cyst 1 (2%) Focal Cellular Change 1 (2%) Hyperplasia, Focal 1 (5%) 1 (2%) Infiltration Cellular, Mixed Cell 1 (2%) Vacuolization Cytoplasmic, Focal 1 (2%) Extra Adrenal Tissue, Fibrosis 1 (2%) Extra Adrenal Tissue, Inflammation, Suppurative 1 (2%) Subcapsular, Hyperplasia, Focal 2 (4%) 2 (10%) 4 (7%) Unilateral, Atrophy 1 (5%) Adrenal Gland, Medulla (54) (21) (21) (53) Hyperplasia, Focal 1 (2%) 1 (5%) 1 (2%) Infiltration Cellular, Mixed Cell 1 (2%) Parathyroid Gland (53) (18) (22) (50) Cyst 1 (5%) Pituitary Gland (52) (21) (17) (49) Pars Distalis, Angiectasis 1 (6%) Pars Distalis, Cyst 1 (2%) Pars Distalis, Hyperplasia, Focal 5 (10%) 1 (6%) 2 (4%) Thyroid Gland (53) (53) (54) (53) Cyst 1 (2%) 2 (4%) Degeneration, Cystic 12 (23%) 13 (25%) 13 (24%) 9 (17%) Fibrosis 1 (2%) Inflammation, Focal 1 (2%) Follicle, Cyst 1 (2%) 4 (7%) Follicular Cell, Hyperplasia 5 (9%) 8 (15%) 4 (7%) 9 (17%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 11 NTP Experiment-Test: 05025-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC ETHYLENE GLYCOL Date: 09/04/94 Route: DOSED FEED Time: 06:04:38 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE UNTREATD 0.625% 1.25% 2.5% CONTROL ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Coagulating Gland (1) (1) Inflammation, Suppurative 1 (100%) Adventitia, Hemorrhage 1 (100%) Ductus Deferens (1) Inflammation, Chronic 1 (100%) Epididymis (54) (21) (22) (54) Granuloma Sperm 1 (5%) 1 (2%) Hyperplasia, Lymphoid 1 (2%) Inflammation, Chronic 2 (4%) Inflammation, Suppurative 1 (2%) Spermatocele 1 (2%) Penis (5) (1) (4) (6) Fibrosis 1 (100%) Hyperplasia 1 (17%) Inflammation, Chronic 1 (20%) 1 (100%) 3 (75%) 1 (17%) Inflammation, Suppurative 1 (20%) Necrosis 2 (40%) 1 (25%) Preputial Gland (12) (6) (7) (12) Degeneration, Cystic 8 (67%) 3 (50%) 3 (43%) 6 (50%) Inflammation, Suppurative 8 (67%) 5 (83%) 2 (29%) 7 (58%) Prostate (53) (20) (22) (54) Dilatation 1 (2%) Edema 1 (2%) Inflammation, Chronic 6 (11%) 1 (5%) 5 (23%) 10 (19%) Seminal Vesicle (52) (23) (23) (54) Dilatation 4 (8%) 3 (13%) 2 (9%) 4 (7%) Inflammation, Chronic 9 (17%) 3 (13%) 1 (4%) 8 (15%) Epithelium, Hyperplasia 1 (4%) Testes (54) (22) (22) (54) Inflammation, Chronic 1 (2%) Mineralization 1 (2%) 1 (5%) 1 (5%) 3 (6%) Necrosis, Multifocal 1 (2%) Germinal Epithelium, Degeneration 3 (6%) 1 (5%) 1 (5%) 5 (9%) Interstitial Cell, Hyperplasia 1 (2%) Tunic, Proliferation Connective Tissue 1 (5%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 12 NTP Experiment-Test: 05025-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC ETHYLENE GLYCOL Date: 09/04/94 Route: DOSED FEED Time: 06:04:38 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE UNTREATD 0.625% 1.25% 2.5% CONTROL ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Blood (1) (3) (1) Neutrophilia 1 (100%) Bone Marrow (54) (21) (22) (54) Atypia Cellular, Focal 1 (2%) Hyperplasia, Neutrophil 1 (2%) 1 (5%) Lymph Node (54) (33) (27) (54) Iliac, Hyperplasia 1 (2%) 1 (4%) 3 (6%) Inguinal, Hyperplasia 2 (4%) 1 (3%) 4 (15%) 1 (2%) Inguinal, Hyperplasia, Lymphoid 2 (4%) Inguinal, Inflammation, Chronic 1 (2%) 1 (2%) Mesenteric, Angiectasis 19 (35%) 17 (52%) 11 (41%) 22 (41%) Mesenteric, Depletion Lymphoid 1 (2%) Mesenteric, Hematopoietic Cell Proliferation 1 (2%) Mesenteric, Hyperplasia 3 (6%) Mesenteric, Hyperplasia, Lymphoid 1 (2%) 2 (6%) 2 (4%) Mesenteric, Hyperplasia, Reticulum Cell 1 (2%) Mesenteric, Inflammation, Chronic, Granulomatous 1 (2%) Mesenteric, Inflammation, Suppurative 1 (2%) Mesenteric, Thrombosis 1 (2%) Lymph Node, Mandibular (45) (19) (17) (51) Angiectasis 2 (4%) Depletion Lymphoid 1 (2%) Hyperplasia, Lymphoid 1 (2%) 4 (8%) Spleen (54) (53) (53) (53) Angiectasis 1 (2%) Congestion 1 (2%) Depletion Cellular 1 (2%) 3 (6%) 1 (2%) Hematopoietic Cell Proliferation 17 (31%) 25 (47%) 25 (47%) 28 (53%) Hyperplasia, Lymphoid 1 (2%) 1 (2%) 2 (4%) Thymus (53) (19) (19) (51) Atypia Cellular 1 (2%) Cyst 1 (2%) 1 (5%) 1 (2%) Degeneration, Cystic 1 (2%) Depletion Lymphoid 1 (2%) 2 (11%) 3 (16%) 7 (14%) Hyperplasia, Reticulum Cell 1 (2%) Epithelial Cell, Hyperplasia, Cystic 1 (2%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Skin (54) (45) (43) (54) Erosion 1 (2%) Exudate 1 (2%) 1 (2%) Fibrosis 1 (2%) Hyperplasia, Melanocyte 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 13 NTP Experiment-Test: 05025-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC ETHYLENE GLYCOL Date: 09/04/94 Route: DOSED FEED Time: 06:04:38 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE UNTREATD 0.625% 1.25% 2.5% CONTROL ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM - CONT Inflammation, Chronic 25 (46%) 24 (53%) 27 (63%) 18 (33%) Metaplasia, Osseous 1 (2%) 1 (2%) Ulcer 4 (7%) 5 (11%) 5 (12%) 9 (17%) Hair Follicle, Atrophy 1 (2%) 1 (2%) 2 (5%) Prepuce, Angiectasis 1 (2%) Prepuce, Fibrosis 1 (2%) Prepuce, Foreign Body 1 (2%) 1 (2%) Prepuce, Inflammation, Chronic 5 (9%) 1 (2%) 2 (5%) 2 (4%) Prepuce, Ulcer 5 (9%) 1 (2%) 3 (7%) 3 (6%) Subcutaneous Tissue, Edema 1 (2%) 1 (2%) 1 (2%) Subcutaneous Tissue, Exudate 1 (2%) Subcutaneous Tissue, Fibrosis 1 (2%) 1 (2%) Subcutaneous Tissue, Foreign Body 1 (2%) 1 (2%) Subcutaneous Tissue, Inflammation, Chronic 1 (2%) Subcutaneous Tissue, Lymphatic, Angiectasis 1 (2%) Tail, Subcutaneous Tissue, Inflammation, Granulomatous 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (54) (21) (22) (54) Distal, Joint, Femur, Arthrosis 1 (2%) 1 (5%) Femur, Hyperostosis 1 (2%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (54) (21) (22) (54) Congestion 1 (2%) Gliosis 1 (2%) Infiltration Cellular, Mixed Cell 1 (5%) Inflammation, Focal 1 (5%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (54) (25) (32) (54) Bacterium 2 (4%) Congestion 5 (9%) 2 (8%) 3 (9%) 3 (6%) Edema 1 (4%) Foreign Body 1 (2%) Hemorrhage 2 (4%) Hyperplasia, Lymphoid 4 (7%) 2 (6%) 4 (7%) Hyperplasia, Macrophage 1 (2%) 2 (6%) 1 (2%) Infiltration Cellular, Mixed Cell 8 (15%) 2 (8%) 7 (22%) 8 (15%) Inflammation, Granulomatous 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 14 NTP Experiment-Test: 05025-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC ETHYLENE GLYCOL Date: 09/04/94 Route: DOSED FEED Time: 06:04:38 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE UNTREATD 0.625% 1.25% 2.5% CONTROL ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM - CONT Pigmentation 1 (2%) Alveolar Epithelium, Hyperplasia 2 (4%) 2 (6%) Artery, Embolus 1 (2%) Interstitium, Inflammation 1 (4%) 1 (2%) Nose (54) (21) (21) (54) Lumen, Exudate 2 (4%) 2 (10%) Lumen, Foreign Body 1 (5%) Nasolacrimal Duct, Foreign Body 1 (2%) Nasolacrimal Duct, Inflammation, Suppurative 2 (4%) 1 (5%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM None ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (54) (53) (53) (54) Angiectasis 1 (2%) Atrophy, Focal 1 (2%) 1 (2%) Bacterium 2 (4%) 1 (2%) 4 (7%) Congestion 3 (6%) 1 (2%) Hematopoietic Cell Proliferation 1 (2%) Infiltration Cellular, Mixed Cell 1 (2%) Inflammation, Suppurative 4 (7%) 1 (2%) 1 (2%) 4 (7%) Metaplasia, Osseous 1 (2%) 1 (2%) 2 (4%) 1 (2%) Mineralization 1 (2%) Necrosis 1 (2%) Necrosis, Focal 2 (4%) Nephropathy 39 (72%) 44 (83%) 41 (77%) 38 (70%) Papilla, Necrosis 1 (2%) 1 (2%) Pelvis, Crystals 1 (2%) Pelvis, Dilatation 2 (4%) Pelvis, Inflammation, Chronic 2 (4%) Pelvis, Mineralization 2 (4%) Pelvis, Transitional Epithelium, Hyperplasia 1 (2%) Renal Tubule, Crystals 8 (15%) Renal Tubule, Degeneration, Hyaline 1 (2%) 1 (2%) Renal Tubule, Dilatation 6 (11%) 2 (4%) 7 (13%) 13 (24%) Renal Tubule, Hyperplasia 1 (2%) Renal Tubule, Mineralization 1 (2%) 1 (2%) Renal Tubule, Necrosis 1 (2%) Renal Tubule, Vacuolization Cytoplasmic 51 (94%) 50 (94%) 48 (91%) 52 (96%) Renal Tubule, Epithelium, Necrosis 2 (4%) 1 (2%) Urethra (1) (4) (2) (18) Fibrosis 1 (25%) a Number of animals examined microscopically at site and number of animals with lesion Page 15 NTP Experiment-Test: 05025-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC ETHYLENE GLYCOL Date: 09/04/94 Route: DOSED FEED Time: 06:04:38 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE UNTREATD 0.625% 1.25% 2.5% CONTROL ____________________________________________________________________________________________________________________________________ URINARY SYSTEM - CONT Hemorrhage 1 (6%) Inflammation, Suppurative 1 (100%) 2 (50%) 2 (100%) 7 (39%) Perforation 1 (100%) Bulbourethral Gland, Dilatation 2 (50%) 1 (6%) Bulbourethral Gland, Fibrosis 1 (25%) Lumen, Crystals 12 (67%) Urinary Bladder (53) (53) (53) (54) Calculus Gross Observation 2 (4%) Calculus Micro Observation Only 2 (4%) Congestion 1 (2%) Hemorrhage 1 (2%) 1 (2%) Hyperplasia, Lymphoid 1 (2%) 2 (4%) 1 (2%) Inflammation, Chronic 1 (2%) 4 (8%) 6 (11%) 8 (15%) Ulcer 1 (2%) Artery, Serosa, Mineralization 1 (2%) Transitional Epithelium, Hyperplasia 1 (2%) 1 (2%) 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 16 ------------------------------------------------------------ ---------- END OF REPORT ---------- ------------------------------------------------------------