TDMS Study 05162-10 Pathology Tables
NTP Experiment-Test: 05162-10 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC DIETHANOLAMINE Date: 06/11/96 Route: SKIN APPLICATION Time: 11:08:11 CORE STUDY Facility: Battelle Columbus Laboratory Chemical CAS #: 111-42-2 Lock Date: 06/04/93 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: 05162-10 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC DIETHANOLAMINE Date: 06/11/96 Route: SKIN APPLICATION Time: 11:08:11 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0 MG/KG 40 MG/KG 80 MG/KG 160 MG/KG ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 50 50 50 50 Early Deaths Natural Death 2 9 8 14 Moribund Sacrifice 4 8 9 13 Survivors Terminal Sacrifice 44 33 33 22 Natural Death 1 Animals Examined Microscopically 50 50 50 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Small, Jejunum (50) (50) (50) (49) Peyer's Patch, Hyperplasia, Lymphoid 1 (2%) Liver (50) (50) (50) (50) Clear Cell Focus 2 (4%) Eosinophilic Focus 3 (6%) 4 (8%) Necrosis 1 (2%) 1 (2%) 1 (2%) Syncytial Alteration 2 (4%) 17 (34%) 18 (36%) Hepatocyte, Vacuolization Cytoplasmic 1 (2%) Periportal, Kupffer Cell, Amyloid Deposition 1 (2%) Mesentery (4) (5) (1) (2) Fat, Inflammation, Chronic 3 (75%) 4 (80%) 1 (50%) Pancreas (50) (50) (50) (49) Inflammation, Granulomatous 1 (2%) Acinus, Atrophy 2 (4%) Acinus, Cytoplasmic Alteration, Focal 1 (2%) Salivary Glands (50) (50) (50) (50) Infiltration Cellular, Lymphocyte 1 (2%) Duct, Cytoplasmic Alteration 1 (2%) Stomach, Forestomach (50) (50) (50) (49) Hyperplasia, Focal, Squamous 1 (2%) 6 (12%) 5 (10%) Mineralization, Diffuse 1 (2%) Stomach, Glandular (50) (50) (50) (49) Necrosis, Focal 3 (6%) Tooth (1) Developmental Malformation 1 (100%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (50) (50) (50) (50) Atrium, Thrombosis 1 (2%) 4 (8%) Myocardium, Degeneration, Acute 1 (2%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 2 NTP Experiment-Test: 05162-10 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC DIETHANOLAMINE Date: 06/11/96 Route: SKIN APPLICATION Time: 11:08:11 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0 MG/KG 40 MG/KG 80 MG/KG 160 MG/KG ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (50) (50) (50) (50) Accessory Adrenal Cortical Nodule 1 (2%) Amyloid Deposition 1 (2%) Angiectasis 1 (2%) 1 (2%) 1 (2%) Degeneration, Diffuse 1 (2%) Hemorrhage 1 (2%) 4 (8%) Hypertrophy, Diffuse 1 (2%) Hypertrophy, Focal 1 (2%) Necrosis 1 (2%) Vacuolization Cytoplasmic, Focal 1 (2%) Zona Reticularis, Pigmentation 1 (2%) Islets, Pancreatic (50) (50) (50) (49) Hyperplasia, Focal 2 (4%) 1 (2%) 2 (4%) Pituitary Gland (50) (50) (47) (44) Pars Distalis, Cyst 1 (2%) 1 (2%) 2 (4%) Pars Distalis, Hemorrhage, Focal 1 (2%) Pars Distalis, Hyperplasia 4 (8%) 4 (8%) 3 (6%) 1 (2%) Pars Intermedia, Hyperplasia 1 (2%) Thyroid Gland (50) (50) (50) (49) Follicle, Cyst 1 (2%) 1 (2%) Follicular Cell, Hyperplasia 18 (36%) 28 (56%) 32 (64%) 39 (80%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Clitoral Gland (46) (48) (46) (43) Cyst 1 (2%) Ovary (49) (50) (49) (49) Atrophy 42 (86%) 35 (70%) 44 (90%) 49 (100%) Thrombosis 1 (2%) 1 (2%) 1 (2%) Follicle, Cyst 10 (20%) 18 (36%) 12 (24%) 10 (20%) Periovarian Tissue, Cyst 1 (2%) 1 (2%) 1 (2%) Periovarian Tissue, Inflammation, Granulomatous 1 (2%) Uterus (50) (50) (50) (50) Angiectasis 1 (2%) Congestion 1 (2%) Hyperplasia 1 (2%) Infiltration Cellular, Lymphocyte 1 (2%) Thrombosis 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 3 NTP Experiment-Test: 05162-10 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC DIETHANOLAMINE Date: 06/11/96 Route: SKIN APPLICATION Time: 11:08:11 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0 MG/KG 40 MG/KG 80 MG/KG 160 MG/KG ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM - CONT Endometrium, Hyperplasia, Cystic 45 (90%) 44 (88%) 31 (62%) 25 (50%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (50) (50) (50) (50) Myelofibrosis 14 (28%) 19 (38%) 11 (22%) 8 (16%) Myeloid Cell, Hyperplasia 1 (2%) 1 (2%) 1 (2%) Lymph Node (9) (2) (5) Lumbar, Infiltration Cellular, Plasma Cell 1 (11%) Mediastinal, Hyperplasia, Lymphoid 1 (11%) Pancreatic, Inflammation, Granulomatous 1 (11%) Lymph Node, Mandibular (46) (48) (46) (43) Hyperplasia, Lymphoid 1 (2%) Infiltration Cellular, Plasma Cell 1 (2%) Necrosis 1 (2%) 3 (7%) Lymph Node, Mesenteric (48) (48) (44) (40) Congestion 1 (2%) Necrosis 2 (4%) 3 (6%) 2 (5%) 7 (18%) Spleen (50) (50) (50) (50) Hematopoietic Cell Proliferation 24 (48%) 31 (62%) 41 (82%) 43 (86%) Hyperplasia, Lymphoid 2 (4%) 1 (2%) Pigmentation, Diffuse, Hemosiderin 1 (2%) Pigmentation, Hemosiderin 1 (2%) Lymphoid Follicle, Depletion Cellular 1 (2%) Thymus (48) (42) (41) (36) Atrophy 3 (6%) 6 (14%) 8 (20%) 21 (58%) Hyperplasia, Lymphoid 1 (2%) Necrosis 6 (14%) 3 (7%) 4 (11%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (49) (47) (47) (40) Hyperplasia 1 (2%) 2 (4%) Skin (50) (50) (50) (50) Skin, Site of Application, Acanthosis 2 (4%) 1 (2%) 2 (4%) Skin, Site of Application, Exudate 1 (2%) 1 (2%) 3 (6%) Skin, Site of Application, Hyperkeratosis 1 (2%) 3 (6%) 8 (16%) 16 (32%) Skin, Site of Application, Ulcer 1 (2%) Subcutaneous Tissue, Edema, Diffuse 1 (2%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 4 NTP Experiment-Test: 05162-10 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC DIETHANOLAMINE Date: 06/11/96 Route: SKIN APPLICATION Time: 11:08:11 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0 MG/KG 40 MG/KG 80 MG/KG 160 MG/KG ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Skeletal Muscle (1) (1) Inflammation, Granulomatous 1 (100%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (50) (50) (50) Hydrocephalus 1 (2%) Cerebrum, Cyst Epithelial Inclusion 1 (2%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (50) (50) (50) Inflammation, Chronic 1 (2%) 1 (2%) Inflammation, Chronic Active 1 (2%) Alveolar Epithelium, Hyperplasia 1 (2%) 2 (4%) 1 (2%) Alveolus, Infiltration Cellular, Histiocyte 2 (4%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (1) (2) Degeneration 2 (100%) Cornea, Inflammation, Chronic Active 1 (100%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (50) (50) (50) Metaplasia, Focal, Osseous 2 (4%) Nephropathy 25 (50%) 24 (48%) 16 (32%) 17 (34%) Cortex, Cyst 1 (2%) 1 (2%) Cortex, Infarct 1 (2%) 2 (4%) Glomerulus, Amyloid Deposition 1 (2%) Renal Tubule, Dilatation 1 (2%) Renal Tubule, Mineralization 4 (8%) 3 (6%) Renal Tubule, Pigmentation 1 (2%) Urinary Bladder (50) (49) (50) (48) Infiltration Cellular, Lymphocyte 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 5 NTP Experiment-Test: 05162-10 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC DIETHANOLAMINE Date: 06/11/96 Route: SKIN APPLICATION Time: 11:08:11 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0 MG/KG 40 MG/KG 80 MG/KG 160 MG/KG ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 50 50 50 50 Early Deaths Natural Death 7 6 10 9 Moribund Sacrifice 3 1 6 10 Accidently Killed 1 Survivors Terminal Sacrifice 40 41 34 30 Natural Death 2 Animals Examined Microscopically 50 50 50 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Cecum (50) (49) (50) (50) Lymphoid Tissue, Hyperplasia, Lymphoid 1 (2%) Lymphoid Tissue, Inflammation, Chronic Active 1 (2%) Intestine Small, Duodenum (50) (49) (49) (50) Peyer's Patch, Hyperplasia, Lymphoid 1 (2%) Liver (50) (50) (50) (50) Basophilic Focus 2 (4%) 1 (2%) Clear Cell Focus 4 (8%) 7 (14%) 2 (4%) 2 (4%) Clear Cell Focus, Multiple 1 (2%) Eosinophilic Focus 3 (6%) 4 (8%) 2 (4%) 4 (8%) Eosinophilic Focus, Multiple 1 (2%) Hematopoietic Cell Proliferation 1 (2%) Hematopoietic Cell Proliferation, Diffuse 1 (2%) Hepatodiaphragmatic Nodule 1 (2%) 1 (2%) Inflammation, Suppurative 1 (2%) Necrosis 2 (4%) Syncytial Alteration 28 (56%) 38 (76%) 23 (46%) Thrombosis 1 (2%) 1 (2%) Centrilobular, Cytoplasmic Alteration 1 (2%) 17 (34%) 17 (34%) 12 (24%) Mesentery (1) Fat, Inflammation, Chronic 1 (100%) Pancreas (50) (50) (50) (50) Inflammation, Chronic Active 1 (2%) Acinus, Atrophy 2 (4%) 2 (4%) 1 (2%) Acinus, Cytoplasmic Alteration 1 (2%) 1 (2%) 3 (6%) Salivary Glands (50) (50) (50) (50) Duct, Cytoplasmic Alteration 1 (2%) 2 (4%) 8 (16%) 23 (46%) Stomach, Forestomach (50) (49) (50) (50) Hyperplasia, Focal, Squamous 1 (2%) 4 (8%) 4 (8%) 2 (4%) Stomach, Glandular (50) (49) (50) (50) Necrosis 1 (2%) 1 (2%) Pigmentation 3 (6%) a Number of animals examined microscopically at site and number of animals with lesion Page 6 NTP Experiment-Test: 05162-10 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC DIETHANOLAMINE Date: 06/11/96 Route: SKIN APPLICATION Time: 11:08:11 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0 MG/KG 40 MG/KG 80 MG/KG 160 MG/KG ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Epithelium, Hyperplasia, Focal 1 (2%) 2 (4%) Tooth (3) (2) Developmental Malformation 1 (33%) 2 (100%) Peridontal Tissue, Inflammation, Chronic Active 2 (67%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Blood Vessel (50) (50) (50) (49) Adventitia, Inflammation, Chronic 1 (2%) Heart (50) (50) (50) (50) Atrium, Thrombosis 6 (12%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (50) (50) (50) (50) Hyperplasia, Focal 1 (2%) 3 (6%) Hypertrophy, Diffuse 1 (2%) Hypertrophy, Focal 6 (12%) 8 (16%) 4 (8%) 7 (14%) Vacuolization Cytoplasmic, Focal 1 (2%) Capsule, Hyperplasia 2 (4%) 6 (12%) 5 (10%) 3 (6%) Islets, Pancreatic (50) (50) (50) (50) Hyperplasia 2 (4%) Parathyroid Gland (41) (41) (41) (43) Cyst 1 (2%) Pituitary Gland (48) (47) (46) (43) Craniopharyngeal Duct, Pars Distalis, Cyst 1 (2%) Pars Distalis, Cyst 2 (4%) 1 (2%) 1 (2%) 3 (7%) Pars Distalis, Hyperplasia 2 (4%) Thyroid Gland (50) (49) (50) (50) Follicular Cell, Hyperplasia 18 (36%) 22 (45%) 30 (60%) 42 (84%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM Tissue NOS (1) Pelvic, Abscess 1 (100%) ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Epididymis (50) (50) (50) (50) Granuloma Sperm 1 (2%) Preputial Gland (50) (50) (50) (49) Cyst 16 (32%) 12 (24%) 20 (40%) 12 (24%) a Number of animals examined microscopically at site and number of animals with lesion Page 7 NTP Experiment-Test: 05162-10 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC DIETHANOLAMINE Date: 06/11/96 Route: SKIN APPLICATION Time: 11:08:11 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0 MG/KG 40 MG/KG 80 MG/KG 160 MG/KG ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM - CONT Inflammation, Chronic Active 3 (6%) 5 (10%) 1 (2%) 3 (6%) Prostate (50) (50) (50) (50) Inflammation, Chronic Active 1 (2%) Inflammation, Diffuse, Suppurative 1 (2%) Seminal Vesicle (50) (50) (50) (50) Inflammation, Diffuse, Suppurative 1 (2%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (50) (50) (50) (50) Myeloid Cell, Depletion Cellular 1 (2%) Lymph Node (1) (2) (1) Hyperplasia, Lymphoid 1 (50%) Lymph Node, Mandibular (46) (46) (44) (36) Necrosis 3 (7%) 2 (5%) 2 (6%) Lymph Node, Mesenteric (45) (43) (41) (41) Angiectasis 1 (2%) Congestion 2 (4%) 1 (2%) Inflammation, Suppurative 1 (2%) Necrosis 4 (9%) 1 (2%) 6 (15%) Spleen (50) (50) (50) (50) Hematopoietic Cell Proliferation 13 (26%) 22 (44%) 29 (58%) 32 (64%) Hyperplasia, Lymphoid 1 (2%) Thrombosis 1 (2%) Lymphoid Follicle, Necrosis 1 (2%) Red Pulp, Depletion Cellular 1 (2%) Thymus (37) (42) (39) (36) Atrophy 8 (22%) 8 (19%) 18 (46%) 17 (47%) Cyst 1 (2%) Necrosis 2 (5%) 1 (2%) 3 (8%) 2 (6%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Skin (50) (50) (50) (50) Hyperkeratosis 1 (2%) Dermis, Fibrosis 1 (2%) Skin, Site of Application, Acanthosis 2 (4%) 4 (8%) Skin, Site of Application, Exudate 3 (6%) Skin, Site of Application, Hyperkeratosis 13 (26%) 10 (20%) 17 (34%) Skin, Site of Application, Inflammation, Chronic 1 (2%) Skin, Site of Application, Ulcer 1 (2%) 1 (2%) Subcutaneous Tissue, Angiectasis 1 (2%) Subcutaneous Tissue, Edema 1 (2%) Subcutaneous Tissue, Fibrosis 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 8 NTP Experiment-Test: 05162-10 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC DIETHANOLAMINE Date: 06/11/96 Route: SKIN APPLICATION Time: 11:08:11 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0 MG/KG 40 MG/KG 80 MG/KG 160 MG/KG ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (50) (50) (50) (50) Hyperostosis 1 (2%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (50) (50) (50) Hemorrhage 1 (2%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (50) (50) (50) Inflammation, Diffuse, Granulomatous 1 (2%) Inflammation, Suppurative 1 (2%) Alveolar Epithelium, Hyperplasia 2 (4%) 2 (4%) 2 (4%) 1 (2%) Alveolus, Infiltration Cellular, Histiocyte 1 (2%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM None ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (50) (50) (50) Hydronephrosis 1 (2%) Infiltration Cellular, Lymphocyte 2 (4%) 1 (2%) Inflammation, Chronic, Diffuse 1 (2%) Nephropathy 45 (90%) 47 (94%) 45 (90%) 48 (96%) Cortex, Cyst 5 (10%) 2 (4%) Cortex, Infarct 1 (2%) Glomerulus, Dilatation, Diffuse 1 (2%) 1 (2%) 1 (2%) Glomerulus, Dilatation, Focal 22 (44%) 39 (78%) 39 (78%) 32 (64%) Pelvis, Inflammation, Suppurative 1 (2%) Renal Tubule, Dilatation 1 (2%) Renal Tubule, Hyperplasia, Focal 1 (2%) 2 (4%) 3 (6%) Renal Tubule, Mineralization 38 (76%) 45 (90%) 38 (76%) 41 (82%) Renal Tubule, Pigmentation, Hemosiderin 1 (2%) 2 (4%) 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 9 NTP Experiment-Test: 05162-10 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC DIETHANOLAMINE Date: 06/11/96 Route: SKIN APPLICATION Time: 11:08:11 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0 MG/KG 40 MG/KG 80 MG/KG 160 MG/KG ____________________________________________________________________________________________________________________________________ URINARY SYSTEM - CONT Renal Tubule, Vacuolization Cytoplasmic 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 10 ------------------------------------------------------------ ---------- END OF REPORT ---------- ------------------------------------------------------------