TDMS Study 05102-05 Pathology Tables
INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)
BENZETHONIUM CHLORIDE
NTP Experiment-Test: 05102-05 Report: PEIRPT03
Study Type: CHRONIC Date: 05/19/95
Route: DERMAL,SOLUTION Time: 18:13:29
Facility: Battelle Columbus Laboratory
Chemical CAS #: 121-54-0
Lock Date: 01/24/92
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: 05102-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC BENZETHONIUM CHLORIDE Date: 05/19/95
Route: DERMAL,SOLUTION Time: 18:13:29
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0MG/KG .15MG/KG 0.5MG/KG 1.5MG/KG
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 60 60 60 60
Scheduled Sacrifice 9 7 9 7
Early Deaths
Moribund Sacrifice 13 11 13 13
Natural Death 14 9 12 16
Survivors
Terminal Sacrifice 24 33 26 24
Animals Examined Microscopically 60 60 60 60
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Intestine Small, Duodenum (2)
Ulcer 2 (100%)
Liver (60) (60)
Angiectasis 2 (3%)
Basophilic Focus 26 (43%) 33 (55%)
Clear Cell Focus 2 (3%) 7 (12%)
Eosinophilic Focus 13 (22%) 13 (22%)
Hepatodiaphragmatic Nodule 9 (15%) 18 (30%)
Hepatodiaphragmatic Nodule, Multiple 1 (2%)
Inflammation, Chronic Active 2 (3%) 2 (3%)
Inflammation, Granulomatous 8 (13%) 11 (18%)
Bile Duct, Hyperplasia 11 (18%) 13 (22%)
Hepatocyte, Degeneration, Cystic 2 (3%)
Hepatocyte, Hypertrophy, Focal 1 (2%)
Hepatocyte, Necrosis 1 (2%)
Hepatocyte, Vacuolization Cytoplasmic 7 (12%) 8 (13%)
Mesentery (4) (4)
Fat, Inflammation, Chronic Active 3 (75%) 4 (100%)
Pancreas (60) (60)
Inflammation, Chronic Active 1 (2%)
Acinus, Atrophy 15 (25%) 17 (28%)
Stomach, Forestomach (6) (8)
Acanthosis 3 (38%)
Inflammation, Chronic Active 1 (13%)
Mineralization 1 (13%)
Ulcer 6 (100%) 5 (63%)
Stomach, Glandular (1)
Necrosis 1 (100%)
Tongue (1)
Cyst 1 (100%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 2
NTP Experiment-Test: 05102-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC BENZETHONIUM CHLORIDE Date: 05/19/95
Route: DERMAL,SOLUTION Time: 18:13:29
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0MG/KG .15MG/KG 0.5MG/KG 1.5MG/KG
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (60) (60)
Degeneration, Chronic 29 (48%) 33 (55%)
Atrium, Thrombosis 3 (5%) 3 (5%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (19) (21)
Degeneration, Cystic 1 (5%) 1 (5%)
Hyperplasia 7 (37%) 12 (57%)
Hypertrophy 1 (5%)
Necrosis 2 (11%) 2 (10%)
Vacuolization Cytoplasmic 8 (42%) 9 (43%)
Adrenal Medulla (10) (2)
Hyperplasia 6 (60%) 1 (50%)
Parathyroid Gland (56) (53)
Hyperplasia 32 (57%) 32 (60%)
Pituitary Gland (60) (60)
Necrosis 1 (2%)
Craniopharyngeal Duct, Pars Distalis, Cyst 1 (2%)
Pars Distalis, Cyst 11 (18%) 12 (20%)
Pars Distalis, Hyperplasia 17 (28%) 20 (33%)
Thyroid Gland (60) (60)
Bilateral, Ultimobranchial Cyst 1 (2%)
C-Cell, Hyperplasia 24 (40%) 17 (28%)
Follicular Cell, Hyperplasia 2 (3%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Clitoral Gland (59) (59)
Hyperplasia 5 (8%) 4 (7%)
Inflammation, Chronic Active 2 (3%) 1 (2%)
Duct, Cyst 1 (2%)
Duct, Ectasia 1 (2%) 2 (3%)
Ovary (60) (60)
Follicle, Cyst 4 (7%) 7 (12%)
Periovarian Tissue, Cyst 8 (13%) 13 (22%)
Uterus (60) (60)
Endometrium, Hyperplasia, Cystic, Glandular 3 (5%) 3 (5%)
Vagina (1)
a Number of animals examined microscopically at site and number of animals with lesion
Page 3
NTP Experiment-Test: 05102-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC BENZETHONIUM CHLORIDE Date: 05/19/95
Route: DERMAL,SOLUTION Time: 18:13:29
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0MG/KG .15MG/KG 0.5MG/KG 1.5MG/KG
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM - CONT
Lumen, Hemorrhage 1 (100%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Blood (2)
Erythrocyte, Atypia Cellular 1 (50%)
Bone Marrow (60) (59)
Femoral, Myelofibrosis 1 (2%)
Lymph Node, Mandibular (7) (3)
Thrombosis 1 (14%)
Lymph Node, Mesenteric (5) (3)
Angiectasis 2 (67%)
Spleen (60) (60)
Fibrosis 1 (2%) 2 (3%)
Hematopoietic Cell Proliferation 1 (2%) 2 (3%)
Thymus (54) (56)
Angiectasis 1 (2%)
Cyst 1 (2%)
Depletion Lymphoid 8 (15%) 9 (16%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (60) (60)
Hyperplasia, Cystic 58 (97%) 56 (93%)
Skin (60) (60) (60) (60)
Acanthosis 2 (3%) 1 (2%)
Hyperkeratosis 1 (2%)
Skin, Control (1) (1)
Acanthosis 1 (100%) 1 (100%)
Sebaceous Gland, Hyperplasia 1 (100%) 1 (100%)
Skin, Site of Application-No Mass (2) (3) (8) (39)
Acanthosis 2 (100%) 3 (100%) 8 (100%) 38 (97%)
Erosion, Focal 1 (3%)
Ulcer 2 (67%) 4 (50%) 23 (59%)
Sebaceous Gland, Hyperplasia 1 (50%) 3 (100%) 7 (88%) 36 (92%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (60) (60)
Femur, Hyperostosis 2 (3%) 2 (3%)
Femur, Osteopetrosis 1 (2%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 4
NTP Experiment-Test: 05102-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC BENZETHONIUM CHLORIDE Date: 05/19/95
Route: DERMAL,SOLUTION Time: 18:13:29
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0MG/KG .15MG/KG 0.5MG/KG 1.5MG/KG
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (60) (60)
Compression 21 (35%) 17 (28%)
Hemorrhage 1 (2%)
Hydrocephalus 8 (13%) 6 (10%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (60) (60)
Inflammation, Chronic Active 2 (3%) 2 (3%)
Alveolar Epithelium, Hyperplasia 1 (2%)
Perivascular, Inflammation, Chronic 1 (2%)
Nose (60) (60)
Mucosa, Inflammation, Chronic Active 4 (7%) 5 (8%)
Sinus, Foreign Body 3 (5%) 5 (8%)
Submucosa, Inflammation, Chronic 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (6) (4)
Phthisis Bulbi 1 (17%)
Lens, Cataract 5 (83%) 4 (100%)
Retina, Atrophy 5 (83%) 4 (100%)
Harderian Gland (1) (1)
Inflammation, Chronic Active 1 (100%) 1 (100%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (60) (60)
Cyst 1 (2%)
Mineralization 8 (13%) 9 (15%)
Nephropathy, Chronic 48 (80%) 53 (88%)
Urinary Bladder (60) (60)
Transitional Epithelium, Hyperplasia 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 5
NTP Experiment-Test: 05102-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC BENZETHONIUM CHLORIDE Date: 05/19/95
Route: DERMAL,SOLUTION Time: 18:13:29
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0MG/KG .15MG/KG 0.5MG/KG 1.5MG/KG
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 60 60 60 60
Scheduled Sacrifice 8 8 5 4
Early Deaths
Natural Death 12 7 11 15
Moribund Sacrifice 25 34 34 25
Accidently Killed 1
Survivors
Natural Death 1
Terminal Sacrifice 15 11 8 16
Animals Examined Microscopically 60 60 60 60
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Intestine Small, Duodenum (3)
Dysplasia 1 (33%)
Ulcer 1 (33%)
Intestine Small, Jejunum (2) (1)
Inflammation, Chronic 1 (50%)
Liver (60) (60)
Basophilic Focus 6 (10%) 7 (12%)
Clear Cell Focus 3 (5%) 3 (5%)
Eosinophilic Focus 4 (7%) 3 (5%)
Hematopoietic Cell Proliferation 1 (2%)
Hepatodiaphragmatic Nodule 6 (10%) 4 (7%)
Inflammation, Chronic Active 3 (5%) 3 (5%)
Inflammation, Granulomatous 2 (3%) 3 (5%)
Bile Duct, Cyst 1 (2%)
Bile Duct, Hyperplasia 37 (62%) 38 (63%)
Hepatocyte, Degeneration, Cystic 4 (7%) 9 (15%)
Hepatocyte, Hyperplasia 1 (2%)
Hepatocyte, Vacuolization Cytoplasmic 22 (37%) 21 (35%)
Mesentery (8) (8)
Artery, Inflammation, Chronic Active 1 (13%) 1 (13%)
Fat, Hemorrhage 1 (13%)
Fat, Inflammation, Chronic Active 3 (38%) 6 (75%)
Pancreas (60) (60)
Acinus, Atrophy 23 (38%) 26 (43%)
Artery, Inflammation, Chronic Active 1 (2%) 1 (2%)
Stomach, Forestomach (10) (13)
Acanthosis 4 (40%) 2 (15%)
Inflammation, Chronic Active 1 (10%) 2 (15%)
Mineralization 1 (10%) 2 (15%)
Ulcer 5 (50%) 8 (62%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 6
NTP Experiment-Test: 05102-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC BENZETHONIUM CHLORIDE Date: 05/19/95
Route: DERMAL,SOLUTION Time: 18:13:29
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0MG/KG .15MG/KG 0.5MG/KG 1.5MG/KG
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Stomach, Glandular (13) (11)
Dysplasia 2 (15%)
Hyperplasia 1 (9%)
Mineralization 5 (38%) 3 (27%)
Necrosis 1 (8%) 2 (18%)
Pigmentation, Hemosiderin 1 (8%)
Ulcer 4 (31%) 5 (45%)
Tongue (1)
Inflammation, Chronic Active 1 (100%)
Tooth (2)
Peridontal Tissue, Inflammation, Chronic
Active 1 (50%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Blood Vessel (1) (1)
Aorta, Mineralization 1 (100%) 1 (100%)
Heart (59) (60)
Degeneration, Chronic 51 (86%) 50 (83%)
Mineralization 1 (2%) 2 (3%)
Atrium, Thrombosis 6 (10%) 4 (7%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (29) (24)
Hyperplasia 13 (45%) 6 (25%)
Hypertrophy 2 (7%)
Vacuolization Cytoplasmic 22 (76%) 20 (83%)
Adrenal Medulla (27) (29)
Hyperplasia 24 (89%) 21 (72%)
Islets, Pancreatic (60) (60)
Hyperplasia 1 (2%) 1 (2%)
Parathyroid Gland (58) (58)
Hyperplasia 37 (64%) 39 (67%)
Pituitary Gland (60) (60)
Pars Distalis, Cyst 7 (12%)
Pars Distalis, Hemorrhage 2 (3%)
Pars Distalis, Hyperplasia 13 (22%) 11 (18%)
Pars Distalis, Vacuolization Cytoplasmic 2 (3%)
Thyroid Gland (59) (60)
Ultimobranchial Cyst 1 (2%)
C-Cell, Hyperplasia 12 (20%) 11 (18%)
Follicle, Cyst 1 (2%)
Follicular Cell, Hyperplasia 1 (2%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 7
NTP Experiment-Test: 05102-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC BENZETHONIUM CHLORIDE Date: 05/19/95
Route: DERMAL,SOLUTION Time: 18:13:29
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0MG/KG .15MG/KG 0.5MG/KG 1.5MG/KG
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Epididymis (60) (60)
Aspermia 2 (3%)
Inflammation, Granulomatous 1 (2%)
Preputial Gland (60) (60)
Inflammation, Chronic Active 46 (77%) 38 (63%)
Duct, Ectasia 1 (2%) 2 (3%)
Prostate (60) (60)
Hyperplasia 1 (2%)
Inflammation, Chronic Active 30 (50%) 26 (43%)
Inflammation, Granulomatous 1 (2%)
Epithelium, Hyperplasia 1 (2%)
Seminal Vesicle (60) (60)
Atrophy 1 (2%)
Inflammation, Chronic Active 1 (2%) 2 (3%)
Mineralization 1 (2%)
Testes (60) (60)
Cyst 1 (2%)
Germinal Epithelium, Degeneration 16 (27%) 17 (28%)
Interstitial Cell, Hyperplasia 17 (28%) 13 (22%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (59) (60)
Femoral, Myelofibrosis 4 (7%) 4 (7%)
Lymph Node (8) (14)
Mediastinal, Congestion 1 (7%)
Mediastinal, Inflammation, Chronic Active 1 (7%)
Pancreatic, Angiectasis 1 (13%)
Lymph Node, Mandibular (13) (17)
Hyperplasia, Lymphoid 1 (8%)
Infiltration Cellular, Plasma Cell 1 (6%)
Lymph Node, Mesenteric (9) (14)
Angiectasis 1 (11%)
Hyperplasia, Lymphoid 1 (7%)
Inflammation, Chronic Active 1 (7%)
Spleen (60) (60)
Fibrosis 14 (23%) 7 (12%)
Infarct 1 (2%)
Thrombosis 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 8
NTP Experiment-Test: 05102-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC BENZETHONIUM CHLORIDE Date: 05/19/95
Route: DERMAL,SOLUTION Time: 18:13:29
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0MG/KG .15MG/KG 0.5MG/KG 1.5MG/KG
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - CONT
Capsule, Thrombosis 1 (2%)
Thymus (52) (51)
Depletion Lymphoid 9 (17%) 7 (14%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (55) (53)
Hyperplasia, Cystic 50 (91%) 49 (92%)
Duct, Cyst 1 (2%)
Skin (60) (60) (60) (60)
Acanthosis 3 (5%) 2 (3%) 1 (2%)
Cyst Epithelial Inclusion 1 (2%)
Hyperkeratosis 1 (2%) 1 (2%) 1 (2%)
Ulcer 1 (2%)
Skin, Control (3) (3) (2) (1)
Acanthosis 3 (100%) 3 (100%) 1 (50%) 1 (100%)
Hyperplasia, Basal Cell 1 (50%)
Dermis, Inflammation, Chronic 1 (33%)
Skin, Site of Application-No Mass (2) (1) (8) (16)
Acanthosis 1 (50%) 6 (75%) 14 (88%)
Acanthosis, Multifocal 1 (13%)
Cyst 1 (6%)
Skin, Site of Application-Mass (5) (3) (4)
Cyst Epithelial Inclusion 1 (20%) 2 (50%)
Skin, Site of Application-No Mass (2) (1) (8) (16)
Hyperkeratosis 2 (13%)
Ulcer 1 (6%)
Skin, Site of Application-Mass (5) (3) (4)
Dermis, Fibrosis 3 (60%) 1 (25%)
Dermis, Mineralization 2 (40%)
Skin, Site of Application-No Mass (2) (1) (8) (16)
Sebaceous Gland, Hyperplasia 4 (50%) 4 (25%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (59) (60)
Tarsal, Fracture 1 (2%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (60) (60)
Compression 14 (23%) 13 (22%)
Hemorrhage 1 (2%)
Hydrocephalus 10 (17%) 6 (10%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 9
NTP Experiment-Test: 05102-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC BENZETHONIUM CHLORIDE Date: 05/19/95
Route: DERMAL,SOLUTION Time: 18:13:29
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0MG/KG .15MG/KG 0.5MG/KG 1.5MG/KG
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (59) (60)
Inflammation, Chronic Active 3 (5%) 2 (3%)
Inflammation, Granulomatous 1 (2%)
Inflammation, Suppurative 1 (2%)
Mineralization 1 (2%) 2 (3%)
Alveolar Epithelium, Hyperplasia 1 (2%)
Alveolar Epithelium, Hyperplasia, Focal 1 (2%)
Nose (60) (59)
Lumen, Hemorrhage 1 (2%)
Mucosa, Inflammation, Chronic Active 6 (10%) 6 (10%)
Mucosa, Ulcer 1 (2%)
Sinus, Foreign Body 6 (10%) 2 (3%)
Submucosa, Inflammation, Acute 1 (2%)
Trachea (59) (60)
Submucosa, Inflammation, Chronic 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (2) (3)
Lens, Cataract 2 (100%) 2 (67%)
Retina, Atrophy 2 (100%) 2 (67%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (60) (60)
Cyst 1 (2%)
Nephropathy, Chronic 60 (100%) 60 (100%)
Cortex, Cyst 1 (2%)
Cortex, Renal Tubule, Mineralization 1 (2%)
Urinary Bladder (60) (60)
Inflammation, Chronic Active 1 (2%)
Transitional Epithelium, Hyperplasia 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 10
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