TDMS Study 05188-05 Pathology Tables
NTP Experiment-Test: 05188-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC SODIUM XYLENESULFONATE Date: 04/04/96
Route: SKIN APPLICATION Time: 04:28:15
Facility: Battelle Columbus Laboratory
Chemical CAS #: 1300-72-7
Lock Date: 07/13/93
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: 05188-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC SODIUM XYLENESULFONATE Date: 04/04/96
Route: SKIN APPLICATION Time: 04:28:15
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 MG/KG 60 MG/KG 120 240
MG/KG MG/KG
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 50 50 50 50
Early Deaths
Moribund Sacrifice 14 10 15 12
Natural Death 13 24 18 22
Accidently Killed 1
Survivors
Terminal Sacrifice 22 15 17 16
Natural Death 1
Animals Examined Microscopically 50 50 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Intestine Large, Colon (50) (35) (33) (50)
Parasite Metazoan 2 (4%) 1 (3%) 3 (6%)
Intestine Large, Rectum (50) (35) (33) (50)
Parasite Metazoan 4 (8%) 3 (9%) 1 (3%) 3 (6%)
Intestine Large, Cecum (50) (35) (33) (50)
Inflammation, Chronic Active 1 (3%) 1 (3%) 1 (2%)
Ulcer 1 (3%)
Intestine Small, Duodenum (50) (35) (33) (50)
Inflammation, Chronic Active 1 (3%)
Ulcer 1 (2%) 1 (3%)
Liver (50) (35) (33) (50)
Angiectasis 1 (2%)
Basophilic Focus 30 (60%) 12 (34%) 11 (33%) 26 (52%)
Clear Cell Focus 1 (2%) 1 (2%)
Hematopoietic Cell Proliferation 1 (2%)
Hepatodiaphragmatic Nodule 10 (20%) 6 (17%) 11 (33%) 3 (6%)
Inflammation, Chronic 21 (42%) 17 (49%) 19 (58%) 24 (48%)
Mixed Cell Focus 1 (2%)
Necrosis 3 (6%) 1 (3%) 3 (9%) 3 (6%)
Pigmentation, Hemosiderin 3 (6%) 1 (3%)
Pigmentation, Melanin 1 (2%)
Bile Duct, Hyperplasia 28 (56%) 13 (37%) 17 (52%) 21 (42%)
Central Vein, Thrombosis 1 (2%)
Hepatocyte, Hyperplasia 2 (4%) 1 (3%) 1 (2%)
Hepatocyte, Vacuolization Cytoplasmic 15 (30%) 4 (12%) 4 (8%)
Hepatocyte, Centrilobular, Degeneration,
Fatty 4 (8%) 1 (3%) 3 (9%) 2 (4%)
Portal Vein, Thrombosis 1 (2%)
Mesentery (2) (4) (4) (4)
Mineralization 1 (50%) 2 (50%) 1 (25%)
Artery, Inflammation, Chronic Active 1 (25%)
Fat, Inflammation, Chronic Active 1 (50%) 2 (50%) 1 (25%) 2 (50%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 2
NTP Experiment-Test: 05188-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC SODIUM XYLENESULFONATE Date: 04/04/96
Route: SKIN APPLICATION Time: 04:28:15
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 MG/KG 60 MG/KG 120 240
MG/KG MG/KG
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Fat, Necrosis 1 (50%) 2 (50%)
Oral Mucosa (1) (2)
Gingival, Inflammation, Chronic Active 2 (100%)
Pancreas (50) (35) (33) (50)
Cyst 1 (3%)
Hypertrophy, Focal 1 (2%)
Inflammation, Chronic Active 1 (3%) 1 (3%)
Acinus, Atrophy 12 (24%) 3 (9%) 5 (15%) 8 (16%)
Artery, Inflammation, Chronic Active 1 (2%) 1 (2%)
Stomach, Forestomach (50) (35) (33) (50)
Inflammation, Chronic Active 2 (4%) 4 (11%) 3 (9%) 4 (8%)
Ulcer 2 (4%) 2 (6%) 3 (9%) 3 (6%)
Epithelium, Hyperplasia 2 (4%) 4 (11%) 3 (9%) 5 (10%)
Stomach, Glandular (50) (35) (33) (50)
Inflammation, Chronic Active 1 (3%) 1 (3%)
Mineralization 1 (2%) 1 (3%)
Necrosis 1 (2%) 1 (3%)
Ulcer 1 (3%)
Epithelium, Erosion 1 (2%) 1 (3%)
Epithelium, Hemorrhage 1 (2%)
Epithelium, Necrosis 1 (2%)
Tooth (1) (1)
Inflammation 1 (100%)
Peridontal Tissue, Inflammation, Chronic
Active 1 (100%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Blood Vessel (50) (35) (33) (50)
Mineralization 1 (2%) 1 (3%)
Heart (50) (35) (33) (50)
Cardiomyopathy, Chronic 16 (32%) 10 (29%) 15 (45%) 23 (46%)
Inflammation, Chronic Active 1 (3%)
Mineralization 1 (2%) 1 (3%)
Atrium, Thrombosis 4 (8%) 1 (3%) 2 (6%) 2 (4%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (50) (35) (33) (50)
Accessory Adrenal Cortical Nodule 2 (4%) 1 (3%) 1 (2%)
Atrophy 1 (2%)
Degeneration, Fatty 24 (48%) 12 (34%) 7 (21%) 14 (28%)
Hyperplasia 17 (34%) 10 (29%) 6 (18%) 17 (34%)
Hypertrophy 1 (2%) 1 (3%) 1 (2%)
Karyomegaly 1 (3%) 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 3
NTP Experiment-Test: 05188-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC SODIUM XYLENESULFONATE Date: 04/04/96
Route: SKIN APPLICATION Time: 04:28:15
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 MG/KG 60 MG/KG 120 240
MG/KG MG/KG
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM - CONT
Necrosis 1 (2%)
Pigmentation, Hemosiderin 1 (2%)
Pigmentation, Lipofuscin 3 (6%) 2 (6%) 4 (12%) 7 (14%)
Adrenal Medulla (50) (35) (33) (50)
Hyperplasia 9 (18%) 3 (9%) 1 (3%) 5 (10%)
Islets, Pancreatic (50) (35) (33) (50)
Hyperplasia 1 (2%) 1 (2%)
Parathyroid Gland (48) (32) (31) (45)
Hyperplasia 1 (2%) 1 (3%)
Pituitary Gland (50) (35) (33) (50)
Angiectasis 36 (72%) 21 (60%) 19 (58%) 31 (62%)
Mineralization 1 (2%) 1 (3%)
Pigmentation, Hematoidin 1 (2%) 1 (3%) 1 (2%)
Pars Distalis, Atypia Cellular 1 (2%)
Pars Distalis, Cyst 21 (42%) 11 (31%) 15 (45%) 29 (58%)
Pars Distalis, Hyperplasia 9 (18%) 11 (31%) 7 (21%) 17 (34%)
Pars Distalis, Pigmentation, Hemosiderin 32 (64%) 20 (57%) 20 (61%) 31 (62%)
Pars Distalis, Thrombosis 1 (3%)
Pars Intermedia, Cyst 2 (6%) 2 (4%)
Thyroid Gland (50) (35) (33) (50)
Ultimobranchial Cyst 1 (2%)
C-Cell, Hyperplasia 7 (14%) 5 (14%) 5 (15%) 8 (16%)
Follicle, Cyst 1 (3%) 1 (2%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Clitoral Gland (49) (50) (50) (50)
Hyperplasia 2 (4%) 2 (4%) 1 (2%) 10 (20%)
Inflammation, Chronic Active 6 (12%) 4 (8%) 4 (8%) 7 (14%)
Duct, Cyst 1 (2%) 2 (4%) 2 (4%)
Duct, Hyperplasia 2 (4%)
Ovary (50) (35) (33) (50)
Cyst 3 (6%) 1 (3%) 2 (6%) 4 (8%)
Inflammation, Chronic Active 1 (3%)
Interstitial Cell, Hyperplasia 2 (6%)
Uterus (50) (35) (33) (50)
Cyst 2 (4%) 1 (3%)
Vagina (1) (1) (1)
Inflammation, Suppurative 1 (100%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 4
NTP Experiment-Test: 05188-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC SODIUM XYLENESULFONATE Date: 04/04/96
Route: SKIN APPLICATION Time: 04:28:15
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 MG/KG 60 MG/KG 120 240
MG/KG MG/KG
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (50) (35) (33) (48)
Hyperplasia 19 (38%) 4 (11%) 12 (36%) 10 (21%)
Inflammation, Granulomatous 1 (2%)
Lymph Node (45) (32) (27) (43)
Lumbar, Hyperplasia, Lymphoid 1 (2%)
Mediastinal, Hyperplasia, Plasma Cell 1 (2%)
Mediastinal, Pigmentation, Hemosiderin 44 (98%) 31 (97%) 27 (100%) 40 (93%)
Pancreatic, Pigmentation, Hemosiderin 1 (2%)
Renal, Pigmentation, Hemosiderin 1 (2%)
Lymph Node, Mandibular (50) (35) (33) (50)
Pigmentation, Hemosiderin 2 (4%) 5 (14%) 6 (18%) 4 (8%)
Lymph Node, Mesenteric (49) (35) (33) (48)
Ectasia 1 (2%)
Inflammation, Suppurative 1 (2%)
Pigmentation, Hemosiderin 1 (2%)
Spleen (50) (35) (33) (50)
Accessory Spleen 2 (4%)
Fibrosis 3 (6%)
Hematopoietic Cell Proliferation 2 (4%) 4 (11%) 3 (9%) 1 (2%)
Necrosis 1 (3%)
Pigmentation, Hemosiderin 4 (8%) 5 (14%) 9 (27%) 11 (22%)
Capsule, Fibrosis 1 (3%)
Capsule, Inflammation, Chronic Active 1 (3%)
Lymphoid Follicle, Depletion Cellular 1 (3%)
Thymus (49) (35) (31) (49)
Cyst 1 (2%) 1 (3%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (50) (35) (33) (50)
Hyperplasia, Cystic 42 (84%) 23 (66%) 27 (82%) 42 (84%)
Duct, Cyst 1 (2%) 1 (2%)
Skin (50) (50) (50) (50)
Hyperkeratosis 1 (2%)
Hyperplasia, Basal Cell 1 (2%)
Inflammation, Chronic Active 1 (2%)
Epidermis, Hyperplasia 1 (2%)
Epidermis, Ulcer 1 (2%)
Epidermis, Skin, Site of Application, Exudate 2 (4%)
Epidermis, Skin, Site of Application,
Hyperplasia 1 (2%) 4 (8%) 5 (10%)
Epidermis, Skin, Site of Application,
Inflammation, Chronic Active 1 (2%)
Epidermis, Skin, Site of Application, Ulcer 1 (2%) 2 (4%) 2 (4%)
Sebaceous Gland, Skin, Site of Application,
a Number of animals examined microscopically at site and number of animals with lesion
Page 5
NTP Experiment-Test: 05188-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC SODIUM XYLENESULFONATE Date: 04/04/96
Route: SKIN APPLICATION Time: 04:28:15
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 MG/KG 60 MG/KG 120 240
MG/KG MG/KG
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM - CONT
Hyperplasia 2 (4%) 2 (4%) 2 (4%)
Skin, Site of Application, Inflammation,
Chronic Active 1 (2%) 2 (4%) 2 (4%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (50) (35) (33) (48)
Fibrous Osteodystrophy 1 (2%) 1 (3%)
Osteopetrosis 1 (2%) 1 (3%)
Femur, Osteosclerosis 1 (3%) 1 (2%)
Femur, Tibia, Osteosclerosis 1 (2%)
Joint, Arthrosis 1 (3%)
Joint, Tarsal, Arthrosis 1 (3%)
Tibia, Fracture 1 (3%)
Skeletal Muscle (1)
Inflammation, Chronic Active 1 (100%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (35) (33) (50)
Hemorrhage, Acute 1 (2%) 1 (2%)
Hydrocephalus 8 (16%) 5 (14%) 3 (9%) 7 (14%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (35) (33) (50)
Congestion, Acute 13 (26%) 14 (40%) 8 (24%) 16 (32%)
Foreign Body 1 (3%)
Inflammation, Chronic Active 3 (6%) 2 (6%) 2 (6%) 4 (8%)
Inflammation, Granulomatous 2 (4%)
Inflammation, Suppurative 1 (2%)
Mineralization 1 (2%) 1 (3%)
Pigmentation, Hemosiderin 1 (3%)
Alveolar Epithelium, Hyperplasia 1 (3%) 4 (8%)
Alveolus, Hemorrhage, Acute 1 (3%)
Alveolus, Infiltration Cellular, Histiocyte 32 (64%) 23 (66%) 20 (61%) 39 (78%)
Interstitium, Inflammation, Chronic Active 9 (18%) 4 (11%) 2 (6%) 5 (10%)
Nose (50) (35) (33) (50)
Inflammation, Chronic Active 4 (8%) 2 (6%) 6 (12%)
Nasolacrimal Duct, Inflammation, Chronic
Active 1 (2%)
Nasolacrimal Duct, Inflammation, Suppurative 10 (20%) 3 (9%) 1 (3%) 6 (12%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 6
NTP Experiment-Test: 05188-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC SODIUM XYLENESULFONATE Date: 04/04/96
Route: SKIN APPLICATION Time: 04:28:15
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 MG/KG 60 MG/KG 120 240
MG/KG MG/KG
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (3) (2) (2) (5)
Cornea, Inflammation, Suppurative 1 (33%)
Lens, Cataract 1 (33%) 2 (100%) 2 (100%) 3 (60%)
Retina, Degeneration 1 (33%) 1 (50%) 2 (100%) 4 (80%)
Retina, Hemorrhage 1 (20%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (35) (33) (50)
Infarct 1 (3%)
Mineralization 10 (20%) 22 (63%) 7 (21%) 11 (22%)
Nephropathy, Chronic 44 (88%) 25 (71%) 27 (82%) 37 (74%)
Pelvis, Transitional Epithelium, Hyperplasia 1 (3%)
Renal Tubule, Pigmentation, Hemosiderin 1 (3%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 7
NTP Experiment-Test: 05188-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC SODIUM XYLENESULFONATE Date: 04/04/96
Route: SKIN APPLICATION Time: 04:28:15
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 MG/KG 60 MG/KG 120 240
MG/KG MG/KG
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 50 50 50 50
Early Deaths
Natural Death 15 8 19 10
Moribund Sacrifice 28 25 22 30
Survivors
Terminal Sacrifice 7 17 9 10
Animals Examined Microscopically 50 50 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Intestine Large, Colon (50) (33) (41) (50)
Parasite Metazoan 4 (8%) 1 (3%) 2 (5%) 3 (6%)
Intestine Large, Rectum (50) (33) (41) (49)
Parasite Metazoan 2 (6%) 1 (2%) 2 (4%)
Intestine Large, Cecum (50) (33) (41) (50)
Inflammation, Chronic Active 1 (3%) 2 (5%) 1 (2%)
Ulcer 1 (3%) 1 (2%) 1 (2%)
Intestine Small, Duodenum (50) (33) (41) (50)
Inflammation, Chronic Active 1 (2%) 1 (3%)
Ulcer 1 (2%) 1 (3%)
Intestine Small, Jejunum (50) (33) (41) (50)
Diverticulum 1 (2%)
Inflammation, Chronic Active 1 (2%) 1 (3%)
Necrosis 1 (2%)
Ulcer 1 (3%)
Intestine Small, Ileum (50) (33) (41) (50)
Inflammation, Chronic Active 2 (6%) 1 (2%)
Parasite Metazoan 1 (2%)
Ulcer 1 (2%)
Liver (50) (45) (47) (50)
Angiectasis 1 (2%)
Basophilic Focus 3 (6%) 3 (6%) 6 (12%)
Clear Cell Focus 3 (6%) 1 (2%)
Degeneration, Cystic 12 (24%) 4 (9%) 8 (17%) 9 (18%)
Hematopoietic Cell Proliferation 1 (2%) 1 (2%) 2 (4%)
Hepatodiaphragmatic Nodule 6 (12%) 2 (4%) 3 (6%) 9 (18%)
Inflammation, Chronic 20 (40%) 9 (20%) 10 (21%) 16 (32%)
Necrosis 8 (16%) 4 (9%) 4 (9%) 2 (4%)
Pigmentation, Hemosiderin 1 (2%)
Bile Duct, Hyperplasia 43 (86%) 29 (64%) 32 (68%) 43 (86%)
Central Vein, Thrombosis 1 (2%)
Hepatocyte, Hyperplasia 1 (2%) 1 (2%) 2 (4%)
Hepatocyte, Vacuolization Cytoplasmic 21 (42%) 11 (24%) 16 (34%) 20 (40%)
Hepatocyte, Centrilobular, Degeneration,
a Number of animals examined microscopically at site and number of animals with lesion
Page 8
NTP Experiment-Test: 05188-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC SODIUM XYLENESULFONATE Date: 04/04/96
Route: SKIN APPLICATION Time: 04:28:15
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 MG/KG 60 MG/KG 120 240
MG/KG MG/KG
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Fatty 2 (4%) 4 (9%)
Hepatocyte, Centrilobular, Necrosis 1 (2%) 3 (7%)
Mesentery (8) (7) (9) (8)
Mineralization 3 (38%) 1 (14%) 2 (22%) 2 (25%)
Artery, Inflammation, Chronic Active 1 (14%)
Fat, Inflammation, Chronic Active 4 (50%) 3 (43%) 4 (44%) 2 (25%)
Fat, Necrosis 1 (11%)
Oral Mucosa (2) (1) (3) (6)
Gingival, Dysplasia 1 (33%)
Gingival, Inflammation, Chronic Active 1 (50%) 1 (100%) 2 (67%) 4 (67%)
Pancreas (50) (33) (41) (50)
Inflammation, Chronic Active 1 (2%)
Acinus, Atrophy 25 (50%) 13 (39%) 16 (39%) 13 (26%)
Acinus, Hyperplasia 3 (6%) 2 (5%) 1 (2%)
Artery, Inflammation, Chronic Active 2 (5%)
Stomach, Forestomach (50) (33) (41) (50)
Cyst 1 (2%) 1 (2%)
Inflammation, Chronic Active 12 (24%) 11 (33%) 11 (27%) 13 (26%)
Mineralization 1 (2%) 2 (5%)
Perforation 1 (2%)
Ulcer 8 (16%) 10 (30%) 10 (24%) 11 (22%)
Epithelium, Hyperplasia 17 (34%) 11 (33%) 10 (24%) 17 (34%)
Stomach, Glandular (50) (33) (41) (50)
Inflammation, Chronic Active 3 (6%) 4 (12%) 1 (2%)
Mineralization 9 (18%) 1 (3%) 5 (12%) 4 (8%)
Necrosis 1 (3%) 1 (2%) 2 (4%)
Ulcer 2 (4%) 3 (9%) 1 (2%)
Epithelium, Erosion 1 (2%) 4 (12%) 3 (7%) 2 (4%)
Epithelium, Hyperplasia 1 (3%)
Tongue (1)
Cyst 1 (100%)
Tooth (1)
Inflammation, Chronic Active 1 (100%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Blood Vessel (50) (33) (41) (50)
Mineralization 8 (16%) 5 (12%) 2 (4%)
Thrombosis 1 (2%)
Heart (50) (33) (41) (50)
Cardiomyopathy, Chronic 29 (58%) 21 (64%) 27 (66%) 28 (56%)
Inflammation, Chronic Active 1 (2%) 1 (3%) 1 (2%)
Mineralization 7 (14%) 1 (3%) 4 (10%) 1 (2%)
Atrium, Thrombosis 4 (8%) 6 (18%) 6 (15%) 8 (16%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 9
NTP Experiment-Test: 05188-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC SODIUM XYLENESULFONATE Date: 04/04/96
Route: SKIN APPLICATION Time: 04:28:15
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 MG/KG 60 MG/KG 120 240
MG/KG MG/KG
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (50) (33) (41) (50)
Accessory Adrenal Cortical Nodule 1 (2%) 1 (2%)
Atrophy 1 (2%)
Degeneration, Fatty 34 (68%) 23 (70%) 29 (71%) 33 (66%)
Hyperplasia 25 (50%) 6 (18%) 17 (41%) 17 (34%)
Hypertrophy 2 (6%) 1 (2%)
Necrosis 1 (2%)
Adrenal Medulla (50) (33) (41) (50)
Hyperplasia 30 (60%) 10 (30%) 17 (41%) 25 (50%)
Islets, Pancreatic (50) (33) (41) (50)
Hyperplasia 2 (6%) 5 (12%) 1 (2%)
Parathyroid Gland (46) (29) (39) (45)
Hyperplasia 13 (28%) 3 (10%) 8 (21%) 5 (11%)
Pituitary Gland (50) (33) (41) (50)
Angiectasis 38 (76%) 26 (79%) 30 (73%) 35 (70%)
Hemorrhage 1 (3%)
Mineralization 5 (10%) 1 (2%)
Necrosis 1 (3%) 1 (2%)
Pigmentation, Hematoidin 2 (4%) 1 (3%) 1 (2%)
Pars Distalis, Atrophy 1 (2%)
Pars Distalis, Cyst 8 (16%) 5 (15%) 10 (24%) 14 (28%)
Pars Distalis, Hyperplasia 12 (24%) 5 (15%) 7 (17%) 17 (34%)
Pars Distalis, Pigmentation, Hemosiderin 33 (66%) 20 (61%) 26 (63%) 35 (70%)
Pars Distalis, Thrombosis 1 (3%) 1 (2%)
Pars Intermedia, Cyst 2 (4%) 2 (6%) 3 (6%)
Pars Nervosa, Cyst 1 (2%)
Thyroid Gland (50) (33) (41) (50)
C-Cell, Hyperplasia 7 (14%) 8 (24%) 7 (17%) 12 (24%)
Follicle, Cyst 2 (4%) 1 (2%) 4 (8%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Coagulating Gland (1) (2)
Inflammation, Chronic Active 1 (100%) 2 (100%)
Epididymis (50) (33) (41) (50)
Atrophy 25 (50%) 10 (30%) 16 (39%) 25 (50%)
Inflammation, Chronic Active 1 (3%)
Mineralization 1 (2%) 2 (5%)
Preputial Gland (50) (33) (40) (50)
Cyst 2 (4%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 10
NTP Experiment-Test: 05188-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC SODIUM XYLENESULFONATE Date: 04/04/96
Route: SKIN APPLICATION Time: 04:28:15
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 MG/KG 60 MG/KG 120 240
MG/KG MG/KG
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM - CONT
Hyperplasia 1 (2%) 1 (3%) 1 (3%) 2 (4%)
Inflammation, Chronic Active 47 (94%) 27 (82%) 38 (95%) 46 (92%)
Duct, Cyst 1 (2%) 1 (3%) 3 (8%)
Prostate (50) (33) (41) (50)
Atrophy 1 (2%)
Cyst 3 (6%)
Inflammation, Chronic Active 49 (98%) 32 (97%) 38 (93%) 47 (94%)
Mineralization 1 (2%)
Seminal Vesicle (50) (33) (41) (50)
Atrophy 3 (6%) 7 (21%) 11 (27%) 13 (26%)
Inflammation, Chronic Active 2 (4%) 1 (3%)
Mineralization 1 (2%)
Testes (50) (33) (41) (50)
Artery, Inflammation, Chronic 10 (20%) 2 (6%) 8 (20%) 9 (18%)
Germinal Epithelium, Atrophy 20 (40%) 6 (18%) 19 (46%) 13 (26%)
Interstitial Cell, Hyperplasia 20 (40%) 13 (39%) 11 (27%) 14 (28%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (50) (32) (41) (50)
Hyperplasia 25 (50%) 13 (41%) 16 (39%) 38 (76%)
Lymph Node (41) (25) (31) (41)
Lumbar, Hyperplasia, Lymphoid 1 (4%)
Mediastinal, Atrophy 1 (2%)
Mediastinal, Ectasia 1 (2%)
Mediastinal, Infiltration Cellular,
Histiocyte 1 (4%)
Mediastinal, Pigmentation, Hemosiderin 37 (90%) 23 (92%) 27 (87%) 36 (88%)
Renal, Ectasia 2 (6%) 1 (2%)
Renal, Erythrophagocytosis 1 (2%)
Renal, Pigmentation, Hemosiderin 1 (3%) 1 (2%)
Lymph Node, Mesenteric (50) (33) (41) (50)
Atrophy 1 (2%)
Ectasia 1 (2%) 3 (9%) 2 (5%) 6 (12%)
Inflammation, Granulomatous 1 (2%)
Spleen (50) (46) (47) (50)
Fibrosis 6 (12%) 4 (9%) 8 (16%)
Hematopoietic Cell Proliferation 12 (24%) 6 (13%) 7 (15%) 10 (20%)
Pigmentation, Hemosiderin 4 (8%) 1 (2%) 4 (8%)
Lymphoid Follicle, Depletion Cellular 1 (2%)
Red Pulp, Depletion Cellular 2 (4%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 11
NTP Experiment-Test: 05188-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC SODIUM XYLENESULFONATE Date: 04/04/96
Route: SKIN APPLICATION Time: 04:28:15
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 MG/KG 60 MG/KG 120 240
MG/KG MG/KG
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (50) (32) (40) (50)
Hyperplasia, Cystic 42 (84%) 26 (81%) 35 (88%) 41 (82%)
Inflammation, Chronic Active 1 (2%)
Duct, Cyst 1 (3%) 3 (8%) 2 (4%)
Skin (50) (50) (50) (50)
Hyperkeratosis 1 (2%)
Epidermis, Skin, Site of Application,
Hyperplasia 1 (2%) 1 (2%) 2 (4%)
Sebaceous Gland, Skin, Site of Application,
Hyperplasia 1 (2%) 1 (2%)
Skin, Site of Application, Inflammation,
Chronic Active 1 (2%)
Subcutaneous Tissue, Inflammation, Chronic
Active 1 (2%)
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MUSCULOSKELETAL SYSTEM
Bone (50) (32) (41) (50)
Fibrous Osteodystrophy 10 (20%) 1 (3%) 9 (22%) 8 (16%)
Femur, Osteosclerosis 1 (2%)
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NERVOUS SYSTEM
Brain (50) (33) (41) (50)
Hemorrhage, Acute 1 (3%) 4 (8%)
Hydrocephalus 11 (22%) 12 (36%) 9 (22%) 5 (10%)
Mineralization 1 (2%)
Necrosis 1 (2%)
Spinal Cord (1) (1) (1)
Axon, Degeneration 1 (100%) 1 (100%)
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RESPIRATORY SYSTEM
Lung (50) (33) (41) (50)
Congestion, Acute 10 (20%) 9 (27%) 17 (41%) 6 (12%)
Inflammation, Chronic Active 3 (6%) 1 (3%) 2 (5%) 3 (6%)
Inflammation, Granulomatous 2 (4%) 1 (2%)
Inflammation, Suppurative 1 (2%) 1 (2%)
Mineralization 7 (14%) 5 (12%)
Necrosis 1 (2%)
Thrombosis 1 (2%)
Alveolar Epithelium, Hyperplasia 3 (6%) 2 (6%) 1 (2%) 3 (6%)
Alveolus, Hemorrhage, Acute 3 (6%) 1 (3%) 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 12
NTP Experiment-Test: 05188-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC SODIUM XYLENESULFONATE Date: 04/04/96
Route: SKIN APPLICATION Time: 04:28:15
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FISCHER 344 RATS MALE 0 MG/KG 60 MG/KG 120 240
MG/KG MG/KG
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RESPIRATORY SYSTEM - CONT
Alveolus, Infiltration Cellular, Histiocyte 24 (48%) 10 (30%) 16 (39%) 16 (32%)
Interstitium, Inflammation, Chronic Active 7 (14%) 4 (10%) 3 (6%)
Nose (50) (32) (41) (50)
Inflammation, Chronic Active 5 (10%) 8 (25%) 4 (10%) 5 (10%)
Polyp Inflammatory 1 (2%)
Thrombosis 1 (3%) 1 (2%)
Nasolacrimal Duct, Inflammation, Suppurative 5 (10%) 3 (9%) 3 (7%) 3 (6%)
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SPECIAL SENSES SYSTEM
Eye (3) (2) (2) (1)
Anterior Chamber, Hemorrhage, Acute 1 (33%)
Cornea, Inflammation, Suppurative 1 (33%)
Lens, Cataract 2 (67%) 1 (50%) 1 (50%) 1 (100%)
Retina, Degeneration 2 (67%) 2 (100%) 1 (50%) 1 (100%)
Harderian Gland (1) (1) (1)
Inflammation, Chronic 1 (100%) 1 (100%)
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URINARY SYSTEM
Kidney (50) (33) (41) (50)
Accumulation, Hyaline Droplet 1 (2%)
Infarct 2 (4%)
Mineralization 4 (8%) 3 (9%) 2 (5%) 1 (2%)
Nephropathy, Chronic 50 (100%) 32 (97%) 41 (100%) 50 (100%)
Cortex, Cyst 8 (16%) 1 (3%) 1 (2%) 10 (20%)
Urinary Bladder (50) (33) (41) (50)
Inflammation, Chronic Active 1 (2%)
Mineralization 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 13
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