TDMS Study 05188-06 Pathology Tables
NTP Experiment-Test: 05188-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC SODIUM XYLENESULFONATE Date: 04/04/96 Route: SKIN APPLICATION Time: 05:02:39 Facility: Battelle Columbus Laboratory Chemical CAS #: 1300-72-7 Lock Date: 07/28/93 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: 05188-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC SODIUM XYLENESULFONATE Date: 04/04/96 Route: SKIN APPLICATION Time: 05:02:39 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0 MG/KG 182 364 727 MG/KG MG/KG MG/KG ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 50 50 50 50 Early Deaths Natural Death 7 10 9 8 Moribund Sacrifice 12 7 9 6 Survivors Terminal Sacrifice 31 32 32 36 Missing 1 Animals Examined Microscopically 50 49 50 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Esophagus (50) (16) (18) (50) Inflammation 1 (6%) Intestine Small, Duodenum (50) (17) (18) (50) Inflammation 1 (2%) Intestine Small, Ileum (50) (17) (18) (50) Hyperplasia, Lymphoid 1 (2%) Liver (50) (49) (50) (50) Angiectasis 1 (2%) Basophilic Focus 3 (6%) 2 (4%) 1 (2%) Clear Cell Focus 1 (2%) Eosinophilic Focus 14 (28%) 11 (22%) 11 (22%) 10 (20%) Hematopoietic Cell Proliferation 2 (4%) 2 (4%) 1 (2%) 1 (2%) Infarct 1 (2%) Inflammation, Chronic Active 22 (44%) 28 (57%) 24 (48%) 21 (42%) Mixed Cell Focus 10 (20%) 3 (6%) 1 (2%) 7 (14%) Necrosis 3 (6%) 4 (8%) 9 (18%) 3 (6%) Pigmentation, Hemosiderin 1 (2%) 1 (2%) Bile Duct, Cyst 2 (4%) Bile Duct, Hyperplasia 4 (8%) 2 (4%) 4 (8%) 2 (4%) Serosa, Necrosis 1 (2%) Mesentery (7) (6) (5) (12) Inflammation 1 (14%) 1 (20%) Fat, Necrosis 3 (43%) 2 (33%) 7 (58%) Pancreas (50) (17) (18) (50) Atrophy 3 (6%) 1 (6%) 6 (12%) Cytoplasmic Alteration 1 (2%) 1 (2%) Inflammation 1 (2%) Necrosis 1 (2%) Duct, Cyst 2 (4%) 2 (12%) 1 (6%) 5 (10%) Salivary Glands (50) (17) (18) (50) Atrophy 1 (2%) 1 (2%) Fibrosis 1 (2%) Stomach, Forestomach (50) (17) (18) (50) a Number of animals examined microscopically at site and number of animals with lesion Page 2 NTP Experiment-Test: 05188-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC SODIUM XYLENESULFONATE Date: 04/04/96 Route: SKIN APPLICATION Time: 05:02:39 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0 MG/KG 182 364 727 MG/KG MG/KG MG/KG ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Erosion 1 (6%) Hyperplasia, Focal 1 (2%) 1 (6%) 3 (6%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Blood Vessel (50) (17) (18) (50) Aorta, Inflammation, Chronic Active 1 (2%) Heart (50) (17) (18) (50) Degeneration 2 (12%) Mineralization 5 (10%) 1 (2%) Atrium, Thrombosis 1 (2%) Epicardium, Inflammation, Suppurative 1 (6%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (50) (17) (18) (50) Accessory Adrenal Cortical Nodule 1 (2%) Degeneration 1 (2%) Hyperplasia 1 (6%) 2 (4%) Capsule, Hyperplasia, Adenomatous 1 (2%) Adrenal Medulla (50) (17) (18) (48) Hyperplasia 3 (6%) 1 (6%) 3 (6%) Islets, Pancreatic (50) (17) (18) (50) Hyperplasia 7 (14%) 1 (6%) 2 (11%) 4 (8%) Pituitary Gland (50) (17) (18) (49) Cyst 1 (2%) Pars Distalis, Hyperplasia 25 (50%) 6 (35%) 11 (61%) 26 (53%) Thyroid Gland (50) (48) (50) (50) Inflammation 1 (2%) Follicle, Cyst 1 (2%) Follicular Cell, Hyperplasia 26 (52%) 19 (40%) 19 (38%) 25 (50%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Ovary (50) (17) (18) (49) Cyst 10 (20%) 2 (11%) 13 (27%) Hemorrhage 1 (2%) Inflammation, Chronic Active 1 (2%) Metaplasia 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 3 NTP Experiment-Test: 05188-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC SODIUM XYLENESULFONATE Date: 04/04/96 Route: SKIN APPLICATION Time: 05:02:39 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0 MG/KG 182 364 727 MG/KG MG/KG MG/KG ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM - CONT Thrombosis 1 (6%) Oviduct (1) Inflammation, Chronic 1 (100%) Uterus (50) (17) (18) (50) Hemorrhage 1 (6%) Hyperplasia, Cystic 21 (42%) 2 (12%) 4 (22%) 22 (44%) Pigmentation, Hemosiderin 1 (2%) Lymphatic, Angiectasis 1 (2%) Lymphatic, Cyst 1 (2%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (50) (17) (18) (50) Hyperplasia 12 (24%) 1 (6%) 4 (22%) 11 (22%) Myelofibrosis 1 (2%) 4 (8%) Lymph Node (7) (3) (6) (6) Mediastinal, Hyperplasia, Lymphoid 1 (14%) Mediastinal, Infiltration Cellular, Histiocyte 1 (17%) Lymph Node, Mesenteric (48) (17) (17) (50) Angiectasis 1 (2%) 2 (4%) Hematopoietic Cell Proliferation 2 (4%) Hemorrhage 1 (6%) Hyperplasia, Lymphoid 1 (2%) Inflammation, Suppurative 1 (2%) Spleen (50) (17) (18) (50) Angiectasis 1 (2%) Hematopoietic Cell Proliferation 19 (38%) 8 (47%) 12 (67%) 11 (22%) Thymus (38) (16) (16) (44) Atrophy 5 (13%) 7 (44%) 4 (25%) 4 (9%) Cyst 1 (6%) Hyperplasia, Lymphoid 2 (5%) 1 (6%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (50) (17) (16) (50) Hyperplasia 5 (10%) 1 (6%) 3 (19%) 6 (12%) Skin (50) (49) (50) (50) Epidermis, Skin, Site of Application, Exudate 1 (2%) 4 (8%) 4 (8%) 1 (2%) Epidermis, Skin, Site of Application, Hyperplasia 4 (8%) 1 (2%) 4 (8%) 4 (8%) Epidermis, Skin, Site of Application, Ulcer 1 (2%) 1 (2%) 1 (2%) Skin, Site of Application, Inflammation, Chronic 4 (8%) 1 (2%) 1 (2%) 1 (2%) Skin, Site of Application, Parakeratosis 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 4 NTP Experiment-Test: 05188-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC SODIUM XYLENESULFONATE Date: 04/04/96 Route: SKIN APPLICATION Time: 05:02:39 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0 MG/KG 182 364 727 MG/KG MG/KG MG/KG ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM - CONT Subcutaneous Tissue, Edema 1 (2%) Subcutaneous Tissue, Skin, Site of Application, Inflammation, Chronic Active 1 (2%) 2 (4%) Subcutaneous Tissue, Skin, Site of Application, Inflammation, Suppurative 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM None ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (17) (18) (50) Inflammation 1 (6%) Neuron, Necrosis 2 (4%) 1 (6%) 4 (22%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (18) (18) (50) Hemorrhage 1 (2%) 1 (2%) Hyperplasia, Lymphoid 1 (2%) Inflammation 1 (2%) Pigmentation, Hemosiderin 1 (2%) Thrombosis 1 (6%) Alveolar Epithelium, Hyperplasia 2 (4%) 2 (4%) Bronchiole, Hyperplasia 1 (2%) 1 (2%) Nose (50) (17) (18) (50) Inflammation, Suppurative 1 (2%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (1) (2) Degeneration 1 (50%) Cornea, Inflammation 1 (100%) Harderian Gland (5) (2) (1) (3) Hyperplasia 1 (20%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 5 NTP Experiment-Test: 05188-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC SODIUM XYLENESULFONATE Date: 04/04/96 Route: SKIN APPLICATION Time: 05:02:39 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0 MG/KG 182 364 727 MG/KG MG/KG MG/KG ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (17) (18) (50) Hydronephrosis 1 (2%) Infarct 1 (6%) Inflammation, Chronic Active 1 (2%) Mineralization 1 (2%) Nephropathy 22 (44%) 1 (6%) 6 (33%) 17 (34%) Pigmentation 2 (4%) Artery, Inflammation, Chronic Active 1 (6%) a Number of animals examined microscopically at site and number of animals with lesion Page 6 NTP Experiment-Test: 05188-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC SODIUM XYLENESULFONATE Date: 04/04/96 Route: SKIN APPLICATION Time: 05:02:39 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0 MG/KG 182 364 727 MG/KG MG/KG MG/KG ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 50 50 50 50 Early Deaths Natural Death 11 10 3 9 Moribund Sacrifice 7 3 8 6 Survivors Terminal Sacrifice 32 37 39 35 Animals Examined Microscopically 50 50 50 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Small, Duodenum (50) (12) (10) (50) Necrosis 1 (2%) Ulcer 1 (2%) Liver (50) (50) (50) (50) Angiectasis 2 (4%) 2 (4%) 1 (2%) Basophilic Focus 2 (4%) 6 (12%) 3 (6%) 4 (8%) Clear Cell Focus 4 (8%) 3 (6%) 3 (6%) 8 (16%) Eosinophilic Focus 13 (26%) 11 (22%) 12 (24%) 9 (18%) Hematopoietic Cell Proliferation 3 (6%) 1 (2%) Hemorrhage 1 (2%) Infarct 1 (2%) Inflammation, Chronic Active 46 (92%) 44 (88%) 41 (82%) 43 (86%) Mixed Cell Focus 3 (6%) 4 (8%) 5 (10%) 7 (14%) Necrosis 8 (16%) 5 (10%) 2 (4%) 8 (16%) Thrombosis 1 (2%) 1 (2%) Vacuolization Cytoplasmic 2 (4%) 1 (2%) 1 (2%) Bile Duct, Hyperplasia 43 (86%) 41 (82%) 36 (72%) 37 (74%) Kupffer Cell, Pigmentation 1 (2%) Mesentery (5) (4) Hemorrhage 1 (25%) Artery, Inflammation, Chronic Active 1 (20%) 1 (25%) Fat, Inflammation 1 (20%) Vein, Thrombosis 1 (20%) 1 (25%) Pancreas (50) (13) (11) (50) Atrophy 3 (6%) 1 (9%) 4 (8%) Cytoplasmic Alteration 4 (8%) Necrosis 1 (2%) 1 (9%) Artery, Inflammation, Chronic Active 2 (4%) Salivary Glands (50) (13) (11) (50) Atrophy 1 (2%) Necrosis 1 (9%) Stomach, Forestomach (50) (13) (11) (50) Cyst 1 (2%) Hyperplasia, Focal 1 (2%) 1 (9%) 2 (4%) a Number of animals examined microscopically at site and number of animals with lesion Page 7 NTP Experiment-Test: 05188-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC SODIUM XYLENESULFONATE Date: 04/04/96 Route: SKIN APPLICATION Time: 05:02:39 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0 MG/KG 182 364 727 MG/KG MG/KG MG/KG ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Ulcer 2 (4%) Stomach, Glandular (50) (13) (11) (50) Erosion 1 (2%) Mineralization 1 (2%) Artery, Inflammation, Chronic Active 1 (2%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Blood Vessel (50) (13) (11) (50) Aorta, Inflammation, Chronic Active 1 (2%) 1 (9%) 1 (2%) Heart (50) (13) (11) (50) Degeneration 2 (4%) 1 (8%) 1 (9%) 1 (2%) Mineralization 1 (2%) 2 (4%) Artery, Inflammation, Chronic Active 1 (2%) 1 (2%) Atrium, Thrombosis 1 (2%) 1 (8%) 1 (9%) 1 (2%) Ventricle, Thrombosis 1 (8%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (50) (12) (11) (50) Accessory Adrenal Cortical Nodule 2 (4%) 1 (9%) 1 (2%) Degeneration, Cystic 1 (2%) Hemorrhage 1 (2%) Hyperplasia 11 (22%) 1 (8%) 1 (9%) 19 (38%) Inflammation, Chronic Active 1 (2%) Capsule, Hyperplasia, Adenomatous 4 (8%) Adrenal Medulla (50) (12) (11) (50) Hyperplasia 2 (4%) 2 (17%) 1 (9%) 1 (2%) Islets, Pancreatic (50) (12) (11) (50) Hyperplasia 9 (18%) 2 (18%) 9 (18%) Parathyroid Gland (46) (9) (7) (42) Cyst 1 (2%) Pituitary Gland (49) (12) (10) (50) Cyst 2 (4%) 2 (4%) Pars Distalis, Hyperplasia 2 (4%) 2 (4%) Pars Intermedia, Hyperplasia 2 (4%) Thyroid Gland (50) (13) (11) (50) Follicular Cell, Hyperplasia 6 (12%) 2 (15%) 10 (20%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 8 NTP Experiment-Test: 05188-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC SODIUM XYLENESULFONATE Date: 04/04/96 Route: SKIN APPLICATION Time: 05:02:39 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0 MG/KG 182 364 727 MG/KG MG/KG MG/KG ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Epididymis (50) (13) (11) (50) Granuloma Sperm 2 (4%) 2 (4%) Artery, Inflammation, Chronic Active 1 (9%) 1 (2%) Preputial Gland (50) (13) (10) (49) Inflammation, Chronic Active 1 (2%) Duct, Cyst 7 (14%) 1 (8%) 4 (40%) 6 (12%) Prostate (50) (13) (11) (50) Degeneration 1 (9%) Artery, Inflammation, Chronic Active 1 (9%) 1 (2%) Seminal Vesicle (50) (13) (11) (50) Degeneration 1 (9%) Testes (50) (13) (11) (50) Atrophy 2 (4%) Artery, Inflammation, Chronic Active 1 (2%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (50) (13) (11) (50) Angiectasis 1 (2%) Hyperplasia 17 (34%) 3 (23%) 4 (36%) 23 (46%) Infiltration Cellular, Mast Cell 1 (2%) Infiltration Cellular, Plasma Cell 1 (2%) Myelofibrosis 1 (2%) Thrombosis 1 (2%) Lymph Node (3) (2) (2) (3) Mediastinal, Angiectasis 1 (33%) Mediastinal, Hematopoietic Cell Proliferation 1 (33%) Lymph Node, Mesenteric (50) (9) (10) (47) Angiectasis 1 (2%) Hematopoietic Cell Proliferation 1 (2%) 1 (10%) Hyperplasia, Histiocytic 1 (2%) Hyperplasia, Lymphoid 1 (2%) 1 (10%) Hyperplasia, Plasma Cell 1 (2%) Spleen (50) (13) (12) (49) Hematopoietic Cell Proliferation 27 (54%) 8 (62%) 8 (67%) 25 (51%) Lymphoid Follicle, Depletion Cellular 1 (2%) Lymphoid Follicle, Hyperplasia 1 (2%) Thymus (37) (11) (6) (34) Atrophy 9 (24%) 5 (45%) 2 (33%) 6 (18%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 9 NTP Experiment-Test: 05188-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC SODIUM XYLENESULFONATE Date: 04/04/96 Route: SKIN APPLICATION Time: 05:02:39 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0 MG/KG 182 364 727 MG/KG MG/KG MG/KG ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Skin (50) (50) (50) (50) Epidermis, Skin, Site of Application, Exudate 1 (2%) 1 (2%) 1 (2%) Epidermis, Skin, Site of Application, Hyperkeratosis 1 (2%) Epidermis, Skin, Site of Application, Hyperplasia 1 (2%) 4 (8%) 5 (10%) Epidermis, Skin, Site of Application, Ulcer 1 (2%) Subcutaneous Tissue, Edema 1 (2%) 1 (2%) 1 (2%) Subcutaneous Tissue, Inflammation, Suppurative 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM None ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (13) (11) (50) Inflammation 1 (9%) Artery, Inflammation, Chronic Active 1 (9%) Corpus Callosum, Degeneration 1 (2%) Neuron, Necrosis 1 (8%) 1 (9%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (16) (15) (50) Inflammation 1 (7%) Pigmentation, Hemosiderin 1 (7%) Thrombosis 1 (7%) Alveolar Epithelium, Hyperplasia 2 (13%) 1 (7%) 2 (4%) Mediastinum, Angiectasis 1 (2%) Nose (50) (13) (11) (50) Inflammation, Suppurative 1 (2%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Ear (2) Inflammation 1 (50%) Harderian Gland (2) (1) (3) Hyperplasia 1 (50%) 1 (33%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 10 NTP Experiment-Test: 05188-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC SODIUM XYLENESULFONATE Date: 04/04/96 Route: SKIN APPLICATION Time: 05:02:39 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0 MG/KG 182 364 727 MG/KG MG/KG MG/KG ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (13) (11) (50) Cyst 5 (10%) 8 (16%) Glomerulosclerosis 2 (4%) 1 (8%) 4 (8%) Hydronephrosis 1 (2%) Infarct 1 (2%) 1 (2%) Mineralization 4 (8%) Nephropathy 43 (86%) 10 (77%) 8 (73%) 43 (86%) Pigmentation, Hemosiderin 1 (2%) 1 (9%) 1 (2%) Artery, Inflammation, Chronic Active 1 (9%) 1 (2%) Glomerulus, Infarct 1 (2%) Glomerulus, Thrombosis 1 (9%) Renal Tubule, Hyperplasia 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 11 ------------------------------------------------------------ ---------- END OF REPORT ---------- ------------------------------------------------------------