TDMS Study 05102-06 Pathology Tables
INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)
BENZETHONIUM CHLORIDE
NTP Experiment-Test: 05102-06 Report: PEIRPT03
Study Type: CHRONIC Date: 05/19/95
Route: DERMAL,SOLUTION Time: 18:39:18
Facility: Battelle Columbus Laboratory
Chemical CAS #: 121-54-0
Lock Date: 01/22/92
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: 05102-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC BENZETHONIUM CHLORIDE Date: 05/19/95
Route: DERMAL,SOLUTION Time: 18:39:18
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0MG/KG .15MG/KG 0.5MG/KG 1.5MG/KG
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 60 60 60 60
Scheduled Sacrifice 8 7 10 6
Early Deaths
Moribund Sacrifice 10 4 8 13
Natural Death 3 15 9 7
Accidently Killed 1
Survivors
Terminal Sacrifice 38 34 31 34
Other 2
Animals Examined Microscopically 60 60 58 60
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Gallbladder (60) (59)
Ulcer 1 (2%)
Intestine Large, Rectum (60) (59)
Artery, Inflammation, Chronic Active 1 (2%)
Intestine Small, Duodenum (59) (59)
Erosion 2 (3%)
Intestine Small, Ileum (60) (58)
Inflammation, Acute 1 (2%)
Liver (60) (60)
Angiectasis 2 (3%) 1 (2%)
Basophilic Focus 1 (2%) 3 (5%)
Clear Cell Focus 1 (2%) 1 (2%)
Developmental Malformation 1 (2%)
Eosinophilic Focus 12 (20%) 17 (28%)
Fibrosis 1 (2%)
Hematopoietic Cell Proliferation 2 (3%) 1 (2%)
Hemorrhage 1 (2%)
Inflammation, Chronic Active 3 (5%)
Mixed Cell Focus 2 (3%) 3 (5%)
Necrosis 5 (8%)
Bile Duct, Cyst 1 (2%)
Centrilobular, Fatty Change 1 (2%)
Hepatocyte, Hyperplasia 1 (2%) 1 (2%)
Mesentery (10) (9)
Inflammation, Chronic Active 1 (11%)
Inflammation, Suppurative 2 (20%) 1 (11%)
Fat, Necrosis 6 (60%) 5 (56%)
Pancreas (60) (59)
Atrophy 2 (3%) 5 (8%)
Atypia Cellular 1 (2%) 2 (3%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 2
NTP Experiment-Test: 05102-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC BENZETHONIUM CHLORIDE Date: 05/19/95
Route: DERMAL,SOLUTION Time: 18:39:18
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0MG/KG .15MG/KG 0.5MG/KG 1.5MG/KG
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Inflammation, Chronic Active 1 (2%)
Duct, Cyst 3 (5%)
Stomach, Forestomach (59) (59)
Erosion 1 (2%)
Hyperplasia 1 (2%) 2 (3%)
Stomach, Glandular (59) (59)
Erosion 1 (2%)
Inflammation, Acute 1 (2%)
Mineralization 1 (2%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (60) (60)
Degeneration 1 (2%)
Inflammation, Chronic Active 3 (5%)
Mineralization 1 (2%)
Artery, Inflammation, Chronic Active 1 (2%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (60) (60)
Accessory Adrenal Cortical Nodule 4 (7%) 3 (5%)
Hyperplasia 3 (5%) 1 (2%)
Capsule, Hyperplasia, Adenomatous 1 (2%)
Adrenal Medulla (59) (60)
Hyperplasia 4 (7%) 2 (3%)
Islets, Pancreatic (60) (58)
Hyperplasia 2 (3%) 3 (5%)
Pituitary Gland (60) (55)
Angiectasis 2 (3%)
Pars Distalis, Hyperplasia 27 (45%) 30 (55%)
Thyroid Gland (60) (60)
Follicle, Cyst 3 (5%)
Follicular Cell, Hyperplasia 20 (33%) 21 (35%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 3
NTP Experiment-Test: 05102-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC BENZETHONIUM CHLORIDE Date: 05/19/95
Route: DERMAL,SOLUTION Time: 18:39:18
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0MG/KG .15MG/KG 0.5MG/KG 1.5MG/KG
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Clitoral Gland (1)
Duct, Ectasia 1 (100%)
Ovary (60) (58)
Angiectasis 1 (2%)
Cyst 27 (45%) 17 (29%)
Cyst Dermoid 1 (2%)
Inflammation, Suppurative 2 (3%) 1 (2%)
Interstitium, Hyperplasia 1 (2%) 2 (3%)
Uterus (60) (59)
Angiectasis 1 (2%) 1 (2%)
Cyst 1 (2%)
Hyperplasia, Cystic 39 (65%) 43 (73%)
Infiltration Cellular, Histiocyte 1 (2%)
Inflammation, Chronic Active 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (60) (59)
Myelofibrosis 13 (22%) 13 (22%)
Erythroid Cell, Hyperplasia 9 (15%) 3 (5%)
Myeloid Cell, Hyperplasia 6 (10%) 4 (7%)
Lymph Node (7) (3)
Mediastinal, Necrosis 1 (14%)
Pancreatic, Hyperplasia 1 (33%)
Lymph Node, Mandibular (60) (60)
Atrophy 1 (2%)
Hematopoietic Cell Proliferation 1 (2%)
Hyperplasia 1 (2%)
Hyperplasia, Lymphoid 2 (3%) 1 (2%)
Lymph Node, Mesenteric (57) (54)
Atrophy 1 (2%)
Hematopoietic Cell Proliferation 1 (2%) 2 (4%)
Hyperplasia, Lymphoid 2 (4%)
Spleen (60) (59)
Angiectasis 1 (2%)
Depletion Lymphoid 2 (3%)
Hematopoietic Cell Proliferation 16 (27%) 24 (41%)
Hyperplasia, Lymphoid 1 (2%) 1 (2%)
Hyperplasia, Macrophage 1 (2%)
Thymus (49) (51)
Depletion Lymphoid 5 (10%) 7 (14%)
Hyperplasia, Lymphoid 3 (6%) 4 (8%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 4
NTP Experiment-Test: 05102-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC BENZETHONIUM CHLORIDE Date: 05/19/95
Route: DERMAL,SOLUTION Time: 18:39:18
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0MG/KG .15MG/KG 0.5MG/KG 1.5MG/KG
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (60) (58)
Hyperplasia 3 (5%) 2 (3%)
Skin, Inguinal (2) (1) (1)
Acanthosis 1 (100%)
Inflammation, Chronic Active 1 (50%)
Skin, Site of Application-No Mass (5) (10) (9) (27)
Acanthosis 3 (60%) 7 (70%) 9 (100%) 26 (96%)
Inflammation, Chronic Active 1 (20%) 2 (20%)
Ulcer 2 (22%)
Sebaceous Gland, Hyperplasia 1 (11%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (60) (59)
Osteopetrosis 1 (2%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (60) (59)
Hemorrhage 1 (2%)
Hydrocephalus 1 (2%)
Neuron, Necrosis 1 (2%) 1 (2%)
Peripheral Nerve (2)
Degeneration 2 (100%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (60) (60)
Hemorrhage 1 (2%)
Alveolar Epithelium, Hyperplasia 3 (5%) 3 (5%)
Alveolus, Pigmentation, Hemosiderin 2 (3%) 2 (3%)
Pleura, Infiltration Cellular, Lymphocyte 1 (2%)
Pleura, Inflammation 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (4) (2)
Degeneration 3 (75%)
Cornea, Inflammation 1 (25%) 1 (50%)
Harderian Gland (44) (35)
Hyperplasia 1 (2%) 2 (6%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 5
NTP Experiment-Test: 05102-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC BENZETHONIUM CHLORIDE Date: 05/19/95
Route: DERMAL,SOLUTION Time: 18:39:18
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0MG/KG .15MG/KG 0.5MG/KG 1.5MG/KG
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (60) (60)
Glomerulosclerosis 1 (2%) 1 (2%)
Nephropathy 33 (55%) 39 (65%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 6
NTP Experiment-Test: 05102-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC BENZETHONIUM CHLORIDE Date: 05/19/95
Route: DERMAL,SOLUTION Time: 18:39:18
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0MG/KG .15MG/KG 0.5MG/KG 1.5MG/KG
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 60 60 60 60
Scheduled Sacrifice 10 9 9 10
Early Deaths
Moribund Sacrifice 3 8 4 9
Natural Death 4 4 4 2
Survivors
Terminal Sacrifice 43 38 42 39
Other 1 1
Animals Examined Microscopically 60 59 59 60
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Intestine Small, Duodenum (60) (60)
Erosion 1 (2%)
Intestine Small, Jejunum (60) (60)
Hyperplasia, Lymphoid 1 (2%) 1 (2%)
Inflammation, Chronic Active 1 (2%)
Liver (60) (60)
Basophilic Focus 2 (3%) 5 (8%)
Clear Cell Focus 13 (22%) 12 (20%)
Eosinophilic Focus 14 (23%) 16 (27%)
Fatty Change, Focal 1 (2%)
Hematopoietic Cell Proliferation 2 (3%)
Infarct 1 (2%)
Mixed Cell Focus 5 (8%) 4 (7%)
Necrosis 1 (2%) 2 (3%)
Mesentery (5) (5)
Inflammation, Chronic Active 1 (20%)
Fat, Necrosis 4 (80%) 1 (20%)
Vein, Thrombosis 1 (20%)
Pancreas (60) (60)
Atrophy 3 (5%) 4 (7%)
Atypia Cellular 4 (7%) 2 (3%)
Concretion 1 (2%)
Cytoplasmic Alteration 1 (2%)
Necrosis 1 (2%)
Duct, Cyst 1 (2%)
Salivary Glands (60) (60)
Atrophy 1 (2%)
Stomach, Forestomach (60) (60)
Erosion 2 (3%)
Hyperplasia 1 (2%) 4 (7%)
Stomach, Glandular (60) (60)
a Number of animals examined microscopically at site and number of animals with lesion
Page 7
NTP Experiment-Test: 05102-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC BENZETHONIUM CHLORIDE Date: 05/19/95
Route: DERMAL,SOLUTION Time: 18:39:18
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0MG/KG .15MG/KG 0.5MG/KG 1.5MG/KG
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Erosion 1 (2%)
Tooth (1) (2)
Inflammation, Chronic Active 1 (50%)
Inflammation, Suppurative 1 (100%) 1 (50%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (60) (60)
Inflammation, Chronic Active 2 (3%) 2 (3%)
Artery, Inflammation, Chronic Active 1 (2%)
Valve, Inflammation, Chronic Active 1 (2%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (60) (60)
Accessory Adrenal Cortical Nodule 1 (2%)
Hyperplasia 40 (67%) 33 (55%)
Capsule, Hyperplasia, Adenomatous 5 (8%) 9 (15%)
Islets, Pancreatic (59) (60)
Hyperplasia 22 (37%) 19 (32%)
Parathyroid Gland (56) (55)
Cyst 1 (2%)
Pituitary Gland (58) (58)
Cyst 2 (3%) 2 (3%)
Pars Distalis, Hyperplasia 2 (3%)
Pars Intermedia, Hyperplasia 3 (5%) 1 (2%)
Thyroid Gland (60) (60)
Inflammation 1 (2%)
Ultimobranchial Cyst 1 (2%)
Follicle, Cyst 3 (5%) 1 (2%)
Follicular Cell, Hyperplasia 10 (17%) 7 (12%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
Tissue NOS (1)
Hemorrhage 1 (100%)
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Epididymis (60) (59)
Inflammation 3 (5%) 5 (8%)
Preputial Gland (19) (18)
Inflammation, Chronic Active 6 (32%) 3 (17%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 8
NTP Experiment-Test: 05102-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC BENZETHONIUM CHLORIDE Date: 05/19/95
Route: DERMAL,SOLUTION Time: 18:39:18
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0MG/KG .15MG/KG 0.5MG/KG 1.5MG/KG
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM - CONT
Duct, Ectasia 19 (100%) 17 (94%)
Prostate (59) (60)
Inflammation, Suppurative 1 (2%)
Artery, Inflammation, Chronic Active 1 (2%)
Seminal Vesicle (60) (60)
Inflammation 1 (2%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (60) (60)
Erythroid Cell, Hyperplasia 4 (7%) 12 (20%)
Myeloid Cell, Hyperplasia 3 (5%) 4 (7%)
Lymph Node, Mandibular (59) (58)
Hyperplasia, Lymphoid 1 (2%)
Lymph Node, Mesenteric (57) (57)
Hyperplasia, Lymphoid 1 (2%)
Inflammation, Granulomatous 1 (2%)
Spleen (60) (60)
Depletion Lymphoid 3 (5%)
Hematopoietic Cell Proliferation 12 (20%) 22 (37%)
Hyperplasia, Lymphoid 1 (2%) 1 (2%)
Inflammation, Granulomatous 1 (2%)
Pigmentation, Hemosiderin 1 (2%)
Thymus (41) (49)
Depletion Lymphoid 4 (10%) 3 (6%)
Hyperplasia, Lymphoid 1 (2%) 2 (4%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Skin, Site of Application-No Mass (2) (7) (18) (34)
Acanthosis 2 (100%) 7 (100%) 18 (100%) 33 (97%)
Inflammation, Chronic Active 2 (6%)
Ulcer 1 (50%) 1 (14%) 4 (22%) 2 (6%)
Sebaceous Gland, Hyperplasia 1 (6%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
None
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 9
NTP Experiment-Test: 05102-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC BENZETHONIUM CHLORIDE Date: 05/19/95
Route: DERMAL,SOLUTION Time: 18:39:18
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0MG/KG .15MG/KG 0.5MG/KG 1.5MG/KG
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (60) (60)
Neuron, Necrosis 2 (3%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (60) (60)
Thrombosis 2 (3%)
Alveolar Epithelium, Hyperplasia 6 (10%) 3 (5%)
Bronchiole, Hyperplasia 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Ear (1) (2)
Necrosis 1 (50%)
Eye (1) (1)
Cornea, Inflammation 1 (100%) 1 (100%)
Harderian Gland (43) (38)
Hyperplasia 2 (5%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (60) (60)
Cyst 1 (2%)
Hydronephrosis 2 (3%) 1 (2%)
Nephropathy 58 (97%) 58 (97%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 10
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