P03 - Incidence Rates of Non-Neoplastic Lesions (Mice)
NTP Experiment-Test: 60946-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: SUBCHRON 90-DAY ESTRAGOLE Date: 10/08/03
Route: GAVAGE Time: 07:58:21
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
Page 1
NTP Experiment-Test: 60946-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: SUBCHRON 90-DAY ESTRAGOLE Date: 10/08/03
Route: GAVAGE Time: 07:58:21
____________________________________________________________________________________________________________________________________
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 (10%)
Gallbladder (10) (10) (10)
Inflammation 1 (10%)
Intestine Large, Colon (10) (10) (10)
Inflammation 1 (10%)
Intestine Large, Cecum (10) (10) (10)
Inflammation 1 (10%)
Goblet Cell, Hyperplasia 1 (10%)
Liver (10) (10) (10) (10) (10) (10)
Basophilic Focus 1 (10%)
Eosinophilic Focus 1 (10%)
Fatty Change, Diffuse 5 (50%)
Inflammation, Chronic Active 10 (100%) 9 (90%) 10 (100%) 10 (100%) 10 (100%) 2 (20%)
Mixed Cell Focus 1 (10%)
Necrosis 10 (100%)
Pigmentation, Hemosiderin 1 (10%)
Bile Duct, Hyperplasia 1 (10%) 2 (20%)
Hepatocyte, Degeneration 1 (10%) 3 (30%) 10 (100%) 10 (100%)
Hepatocyte, Hypertrophy 3 (30%) 10 (100%) 10 (100%)
Oval Cell, Hyperplasia 1 (10%) 10 (100%) 10 (100%) 10 (100%) 5 (50%)
Mesentery (2)
Fat, Inflammation 1 (50%)
Fat, Necrosis 1 (50%)
Salivary Glands (10) (10) (10)
Cytoplasmic Alteration 10 (100%)
Stomach, Forestomach (10) (10) (10) (9) (10) (10)
Hyperplasia, Squamous 6 (60%)
Mineralization 6 (60%)
Ulcer 6 (60%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 2
NTP Experiment-Test: 60946-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: SUBCHRON 90-DAY ESTRAGOLE Date: 10/08/03
Route: GAVAGE Time: 07:58:21
____________________________________________________________________________________________________________________________________
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 (10%)
Stomach, Glandular (10) (10) (10) (10) (10) (10)
Atrophy 1 (10%)
Infiltration Cellular, Polymorphonuclear 1 (10%)
Mineralization 1 (10%) 2 (20%)
Epithelium, Glands, Degeneration 1 (10%) 5 (50%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
None
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (10) (10) (10)
Subcapsular, Hyperplasia 10 (100%) 10 (100%) 6 (60%)
Parathyroid Gland (7) (8) (8)
Cyst 1 (14%)
Thyroid Gland (10) (10) (10)
Infiltration Cellular, Lymphocyte 1 (10%)
Follicle, Cyst 1 (10%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Clitoral Gland (10) (1) (10) (10)
Pigmentation, Melanin 1 (100%)
Uterus (10) (10) (10)
Endometrium, Hyperplasia, Cystic 1 (10%) 1 (10%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Lymph Node (3)
Mediastinal, Atrophy 1 (33%)
Mediastinal, Infiltration Cellular,
Histiocyte 1 (33%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 3
NTP Experiment-Test: 60946-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: SUBCHRON 90-DAY ESTRAGOLE Date: 10/08/03
Route: GAVAGE Time: 07:58:21
____________________________________________________________________________________________________________________________________
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 (33%)
Renal, Atrophy 1 (33%)
Lymph Node, Mandibular (10) (9) (9) (10) (9) (8)
Atrophy 7 (88%)
Lymph Node, Mesenteric (10) (10) (10) (10) (10) (10)
Atrophy 9 (90%)
Infiltration Cellular, Polymorphonuclear 1 (10%)
Spleen (10) (10) (10) (10) (10) (10)
Hematopoietic Cell Proliferation 10 (100%) 10 (100%) 10 (100%) 10 (100%) 10 (100%) 2 (20%)
Lymphoid Follicle, Atrophy 10 (100%)
Red Pulp, Depletion Cellular 9 (90%)
Thymus (10) (10) (10)
Necrosis, Lymphoid 10 (100%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
None
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
None
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
None
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (10) (10) (10)
Congestion 1 (10%)
Nose (10) (10) (10) (10) (10) (10)
Olfactory Epithelium, Degeneration 2 (20%) 10 (100%) 10 (100%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
None
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 4
NTP Experiment-Test: 60946-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: SUBCHRON 90-DAY ESTRAGOLE Date: 10/08/03
Route: GAVAGE Time: 07:58:21
____________________________________________________________________________________________________________________________________
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 (50%) 1 (10%) 1 (10%)
Papilla, Mineralization 1 (10%)
Urinary Bladder (10) (10) (10)
Infiltration Cellular, Mononuclear Cell 1 (10%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 5
NTP Experiment-Test: 60946-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: SUBCHRON 90-DAY ESTRAGOLE Date: 10/08/03
Route: GAVAGE Time: 07:58:21
____________________________________________________________________________________________________________________________________
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 (10%)
Liver (10) (10) (10) (10) (10) (10)
Eosinophilic Focus 1 (10%)
Hematopoietic Cell Proliferation 1 (10%)
Inflammation, Chronic Active 2 (20%) 2 (20%) 4 (40%) 4 (40%) 7 (70%) 7 (70%)
Hepatocyte, Degeneration 5 (50%) 10 (100%)
Hepatocyte, Hypertrophy 8 (80%) 10 (100%)
Oval Cell, Hyperplasia 10 (100%) 9 (90%)
Salivary Glands (10) (10) (10)
Cytoplasmic Alteration 1 (10%)
Stomach, Forestomach (10) (10) (10) (10) (10) (10)
Hyperplasia, Squamous 1 (10%)
Inflammation 1 (10%)
Mineralization 1 (10%)
Stomach, Glandular (10) (10) (10) (10) (10) (10)
Dilatation 1 (10%)
Infiltration Cellular, Polymorphonuclear 3 (30%)
Mineralization 1 (10%)
Epithelium, Glands, Atrophy 1 (10%)
Epithelium, Glands, Degeneration 1 (10%)
Glands, Ectasia 1 (10%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
None
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
a Number of animals examined microscopically at site and number of animals with lesion
Page 6
NTP Experiment-Test: 60946-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: SUBCHRON 90-DAY ESTRAGOLE Date: 10/08/03
Route: GAVAGE Time: 07:58:21
____________________________________________________________________________________________________________________________________
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 (50%) 6 (60%)
Parathyroid Gland (10) (8)
Cyst 1 (13%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Preputial Gland (10) (10)
Atrophy 1 (10%)
Ectasia 1 (10%)
Seminal Vesicle (10) (10)
Atrophy 1 (10%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (10) (10)
Atrophy 1 (10%)
Lymph Node, Mandibular (10) (10) (10) (10) (10) (10)
Atrophy 1 (10%)
Lymph Node, Mesenteric (10) (10) (10) (10) (10) (10)
Atrophy 1 (10%)
Spleen (10) (10) (10) (10) (10) (10)
Hematopoietic Cell Proliferation 10 (100%) 10 (100%) 10 (100%) 10 (100%) 10 (100%) 8 (80%)
Lymphoid Follicle, Atrophy 1 (10%)
Thymus (10) (10)
Atrophy 1 (10%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
None
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
None
a Number of animals examined microscopically at site and number of animals with lesion
Page 7
NTP Experiment-Test: 60946-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: SUBCHRON 90-DAY ESTRAGOLE Date: 10/08/03
Route: GAVAGE Time: 07:58:21
____________________________________________________________________________________________________________________________________
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 (10%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (10) (10)
Congestion, Diffuse 1 (10%)
Nose (10) (10) (10) (10) (10) (10)
Inflammation 1 (10%)
Olfactory Epithelium, Degeneration 1 (10%) 2 (20%) 10 (100%) 10 (100%)
Trachea (10) (10)
Inflammation 1 (10%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Harderian Gland (10) (10)
Infiltration Cellular, Mononuclear Cell 1 (10%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (10) (10) (10) (10) (10) (10)
Nephropathy 3 (30%) 5 (50%) 2 (20%) 4 (40%) 4 (40%) 2 (20%)
Papilla, Mineralization 1 (10%) 1 (10%) 1 (10%)
Renal Tubule, Vacuolization Cytoplasmic 9 (90%) 9 (90%) 2 (20%) 1 (10%)
Urinary Bladder (10) (10)
Infiltration Cellular, Mononuclear Cell 1 (10%)
Inflammation 1 (10%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 8
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