P18 - Incidence Rates of Non-Neoplastic Lesions (Mice)
NTP Experiment-Test: 60946-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: SUBCHRON 90-DAY WITH AVERAGE SEVERITY GRADES[b] Date: 10/08/03
Route: GAVAGE ESTRAGOLE Time: 08:06:08
FINAL/MICE
Facility: Battelle Columbus Laboratory
Chemical CAS #: 140-67-0
Lock Date: 05/28/02
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
b Average severity grade (1-minimal;2-mild;3-moderate;4-marked)
Page 1
NTP Experiment-Test: 60946-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: SUBCHRON 90-DAY WITH AVERAGE SEVERITY GRADES[b] Date: 10/08/03
Route: GAVAGE ESTRAGOLE Time: 08:06:08
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 MG/KG 37.5 75 150 300 600
MG/KG MG/KG MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 10 10 10 10 10 10
Early Deaths
Natural Death 8
Moribund Sacrifice 2
Survivors
Terminal Sacrifice 10 10 10 10 10
Animals Examined Microscopically 10 10 10 10 10 10
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Esophagus (10) (10) (10)
Muscularis, Degeneration 1 [1.0]
Gallbladder (10) (10) (10)
Inflammation 1 [1.0]
Intestine Large, Colon (10) (10) (10)
Inflammation 1 [2.0]
Intestine Large, Cecum (10) (10) (10)
Inflammation 1 [2.0]
Goblet Cell, Hyperplasia 1 [1.0]
Liver (10) (10) (10) (10) (10) (10)
Basophilic Focus 1
Eosinophilic Focus 1
Fatty Change, Diffuse 5 [1.6]
Inflammation, Chronic Active 10 [1.0] 9 [1.1] 10 [1.1] 10 [1.4] 10 [1.3] 2 [2.0]
Mixed Cell Focus 1
Necrosis 10 [3.4]
Pigmentation, Hemosiderin 1 [1.0]
Bile Duct, Hyperplasia 1 [1.0] 2 [1.0]
Hepatocyte, Degeneration 1 [1.0] 3 [1.0] 10 [1.5] 10 [2.0]
Hepatocyte, Hypertrophy 3 [1.0] 10 [2.0] 10 [2.9]
Oval Cell, Hyperplasia 1 [1.0] 10 [1.0] 10 [2.0] 10 [2.7] 5 [1.4]
Mesentery (2)
Fat, Inflammation 1 [3.0]
Fat, Necrosis 1 [1.0]
Salivary Glands (10) (10) (10)
Cytoplasmic Alteration 10 [2.3]
Stomach, Forestomach (10) (10) (10) (9) (10) (10)
Hyperplasia, Squamous 6 [1.5]
Mineralization 6 [1.8]
Ulcer 6 [2.0]
a Number of animals examined microscopically at site and number of animals with lesion
b Average severity grade (1-minimal;2-mild;3-moderate;4-marked)
Page 2
NTP Experiment-Test: 60946-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: SUBCHRON 90-DAY WITH AVERAGE SEVERITY GRADES[b] Date: 10/08/03
Route: GAVAGE ESTRAGOLE Time: 08:06:08
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 MG/KG 37.5 75 150 300 600
MG/KG MG/KG MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Epithelium, Necrosis 1 [2.0]
Stomach, Glandular (10) (10) (10) (10) (10) (10)
Atrophy 1 [1.0]
Infiltration Cellular, Polymorphonuclear 1 [1.0]
Mineralization 1 [1.0] 2 [1.0]
Epithelium, Glands, Degeneration 1 [1.0] 5 [1.6]
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
None
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (10) (10) (10)
Subcapsular, Hyperplasia 10 [1.7] 10 [1.6] 6 [1.0]
Parathyroid Gland (7) (8) (8)
Cyst 1 [1.0]
Thyroid Gland (10) (10) (10)
Infiltration Cellular, Lymphocyte 1 [2.0]
Follicle, Cyst 1 [1.0]
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Clitoral Gland (10) (1) (10) (10)
Pigmentation, Melanin 1 [2.0]
Uterus (10) (10) (10)
Endometrium, Hyperplasia, Cystic 1 [1.0] 1 [1.0]
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Lymph Node (3)
Mediastinal, Atrophy 1 [2.0]
Mediastinal, Infiltration Cellular,
Histiocyte 1 [1.0]
a Number of animals examined microscopically at site and number of animals with lesion
b Average severity grade (1-minimal;2-mild;3-moderate;4-marked)
Page 3
NTP Experiment-Test: 60946-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: SUBCHRON 90-DAY WITH AVERAGE SEVERITY GRADES[b] Date: 10/08/03
Route: GAVAGE ESTRAGOLE Time: 08:06:08
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 MG/KG 37.5 75 150 300 600
MG/KG MG/KG MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - CONT
Pancreatic, Atrophy 1 [3.0]
Renal, Atrophy 1 [4.0]
Lymph Node, Mandibular (10) (9) (9) (10) (9) (8)
Atrophy 7 [2.0]
Lymph Node, Mesenteric (10) (10) (10) (10) (10) (10)
Atrophy 9 [3.4]
Infiltration Cellular, Polymorphonuclear 1 [2.0]
Spleen (10) (10) (10) (10) (10) (10)
Hematopoietic Cell Proliferation 10 [1.1] 10 [1.0] 10 [1.0] 10 [1.1] 10 [1.0] 2 [1.0]
Lymphoid Follicle, Atrophy 10 [2.5]
Red Pulp, Depletion Cellular 9 [2.0]
Thymus (10) (10) (10)
Necrosis, Lymphoid 10 [4.0]
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
None
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
None
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
None
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (10) (10) (10)
Congestion 1 [2.0]
Nose (10) (10) (10) (10) (10) (10)
Olfactory Epithelium, Degeneration 2 [1.0] 10 [1.1] 10 [3.4]
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
None
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
b Average severity grade (1-minimal;2-mild;3-moderate;4-marked)
Page 4
NTP Experiment-Test: 60946-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: SUBCHRON 90-DAY WITH AVERAGE SEVERITY GRADES[b] Date: 10/08/03
Route: GAVAGE ESTRAGOLE Time: 08:06:08
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 MG/KG 37.5 75 150 300 600
MG/KG MG/KG MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (10) (9) (9) (10) (10) (10)
Nephropathy 5 [1.0] 1 [1.0] 1 [1.0]
Papilla, Mineralization 1 [1.0]
Urinary Bladder (10) (10) (10)
Infiltration Cellular, Mononuclear Cell 1 [1.0]
a Number of animals examined microscopically at site and number of animals with lesion
b Average severity grade (1-minimal;2-mild;3-moderate;4-marked)
Page 5
NTP Experiment-Test: 60946-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: SUBCHRON 90-DAY WITH AVERAGE SEVERITY GRADES[b] Date: 10/08/03
Route: GAVAGE ESTRAGOLE Time: 08:06:08
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 MG/KG 37.5 75 150 300 600
MG/KG MG/KG MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 10 10 10 10 10 10
Early Deaths
Moribund Sacrifice 1
Survivors
Terminal Sacrifice 10 10 10 10 10 9
Animals Examined Microscopically 10 10 10 10 10 10
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Gallbladder (10) (10)
Infiltration Cellular, Mixed Cell 1 [1.0]
Liver (10) (10) (10) (10) (10) (10)
Eosinophilic Focus 1
Hematopoietic Cell Proliferation 1 [1.0]
Inflammation, Chronic Active 2 [1.0] 2 [1.0] 4 [1.0] 4 [1.0] 7 [1.0] 7 [1.0]
Hepatocyte, Degeneration 5 [1.0] 10 [1.6]
Hepatocyte, Hypertrophy 8 [1.1] 10 [2.7]
Oval Cell, Hyperplasia 10 [1.0] 9 [2.3]
Salivary Glands (10) (10) (10)
Cytoplasmic Alteration 1 [2.0]
Stomach, Forestomach (10) (10) (10) (10) (10) (10)
Hyperplasia, Squamous 1 [3.0]
Inflammation 1 [1.0]
Mineralization 1 [1.0]
Stomach, Glandular (10) (10) (10) (10) (10) (10)
Dilatation 1 [1.0]
Infiltration Cellular, Polymorphonuclear 3 [1.3]
Mineralization 1 [2.0]
Epithelium, Glands, Atrophy 1 [2.0]
Epithelium, Glands, Degeneration 1 [2.0]
Glands, Ectasia 1 [1.0]
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
None
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
a Number of animals examined microscopically at site and number of animals with lesion
b Average severity grade (1-minimal;2-mild;3-moderate;4-marked)
Page 6
NTP Experiment-Test: 60946-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: SUBCHRON 90-DAY WITH AVERAGE SEVERITY GRADES[b] Date: 10/08/03
Route: GAVAGE ESTRAGOLE Time: 08:06:08
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 MG/KG 37.5 75 150 300 600
MG/KG MG/KG MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM - CONT
Adrenal Cortex (10) (10)
Subcapsular, Hyperplasia 5 [1.0] 6 [1.0]
Parathyroid Gland (10) (8)
Cyst 1
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Preputial Gland (10) (10)
Atrophy 1 [2.0]
Ectasia 1 [2.0]
Seminal Vesicle (10) (10)
Atrophy 1 [3.0]
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (10) (10)
Atrophy 1 [2.0]
Lymph Node, Mandibular (10) (10) (10) (10) (10) (10)
Atrophy 1 [4.0]
Lymph Node, Mesenteric (10) (10) (10) (10) (10) (10)
Atrophy 1 [4.0]
Spleen (10) (10) (10) (10) (10) (10)
Hematopoietic Cell Proliferation 10 [1.0] 10 [1.0] 10 [1.0] 10 [1.0] 10 [1.0] 8 [1.0]
Lymphoid Follicle, Atrophy 1 [3.0]
Thymus (10) (10)
Atrophy 1 [4.0]
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
None
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
None
a Number of animals examined microscopically at site and number of animals with lesion
b Average severity grade (1-minimal;2-mild;3-moderate;4-marked)
Page 7
NTP Experiment-Test: 60946-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: SUBCHRON 90-DAY WITH AVERAGE SEVERITY GRADES[b] Date: 10/08/03
Route: GAVAGE ESTRAGOLE Time: 08:06:08
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 MG/KG 37.5 75 150 300 600
MG/KG MG/KG MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (10) (10)
Venule, Infiltration Cellular, Mixed Cell 1 [1.0]
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (10) (10)
Congestion, Diffuse 1 [2.0]
Nose (10) (10) (10) (10) (10) (10)
Inflammation 1 [2.0]
Olfactory Epithelium, Degeneration 1 [2.0] 2 [1.0] 10 [1.2] 10 [1.6]
Trachea (10) (10)
Inflammation 1 [1.0]
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Harderian Gland (10) (10)
Infiltration Cellular, Mononuclear Cell 1 [1.0]
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (10) (10) (10) (10) (10) (10)
Nephropathy 3 [1.0] 5 [1.0] 2 [1.0] 4 [1.0] 4 [1.0] 2 [1.0]
Papilla, Mineralization 1 [1.0] 1 [1.0] 1 [1.0]
Renal Tubule, Vacuolization Cytoplasmic 9 [1.2] 9 [1.0] 2 [1.0] 1 [1.0]
Urinary Bladder (10) (10)
Infiltration Cellular, Mononuclear Cell 1 [1.0]
Inflammation 1 [1.0]
a Number of animals examined microscopically at site and number of animals with lesion
b Average severity grade (1-minimal;2-mild;3-moderate;4-marked)
Page 8
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