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
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