P18 - Incidence Rates of Non-Neoplastic Lesions (Rats)
NTP Experiment-Test: 60946-01 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: 09:17:23
FINAL/RATS
Facility: Battelle Columbus Laboratory
Chemical CAS #: 140-67-0
Lock Date: 09/03/02
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: 60946-01 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: 09:17:23
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS 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
Survivors
Terminal Sacrifice 10 10 10 10 10 10
Animals Examined Microscopically 10 10 10 10 10 10
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Liver (10) (10) (10) (10) (10) (10)
Basophilic Focus 3 6 10 10
Cholangiofibrosis 1 [2.0]
Clear Cell Focus 1
Eosinophilic Focus 10
Hepatodiaphragmatic Nodule 2 2 2 1 2
Inflammation, Chronic 4 [1.0] 4 [1.0] 5 [1.0] 6 [1.0] 3 [1.0]
Mixed Cell Focus 1 6 10 10
Bile Duct, Hyperplasia 10 [1.0] 10 [1.0] 10 [1.0] 10 [2.0] 10 [2.0]
Hepatocyte, Hypertrophy 10 [1.0] 10 [2.0] 10 [4.0]
Oval Cell, Hyperplasia 10 [1.0] 10 [1.0] 10 [1.0] 10 [2.0] 10 [3.0]
Periportal, Infiltration Cellular, Histiocyte 10 [1.0] 10 [2.0] 10 [2.0]
Periportal, Inflammation, Chronic 5 [1.0] 10 [1.0] 10 [1.0] 10 [2.0] 10 [2.0]
Mesentery (1)
Accessory Spleen 1 [1.0]
Fat, Necrosis 1 [1.0]
Salivary Glands (10) (10) (10) (10) (10) (10)
Submandibular Gland, Cytoplasmic Alteration 10 [1.0] 10 [1.0] 10 [2.0] 10 [2.0]
Stomach, Glandular (10) (10) (10) (10) (10) (10)
Mineralization 1 [1.0] 2 [1.0]
Necrosis, Focal 1 [1.0]
Epithelium, Glands, Atrophy 8 [1.0] 10 [1.3] 10 [2.0]
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (10) (10)
Infiltration Cellular, Mononuclear Cell 1 [1.0]
Myocardium, Infiltration Cellular,
Mononuclear Cell 2 [1.0] 2 [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 2
NTP Experiment-Test: 60946-01 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: 09:17:23
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 MG/KG 37.5 75 150 300 600
MG/KG MG/KG MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
None
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Uterus (10) (10)
Endometrium, Hyperplasia, Cystic 3 [1.7]
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (10) (10)
Hyperplasia 1 [1.0]
Lymph Node (4)
Pancreatic, Hyperplasia, Lymphoid 4 [2.0]
Pancreatic, Infiltration Cellular, Histiocyte 4 [2.3]
Lymph Node, Mesenteric (10) (10) (10) (10) (10) (10)
Hyperplasia, Lymphoid 3 [1.7]
Infiltration Cellular, Histiocyte 1 [1.0] 1 [2.0]
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
None
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
None
____________________________________________________________________________________________________________________________________
NERVOUS 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 3
NTP Experiment-Test: 60946-01 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: 09:17:23
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 MG/KG 37.5 75 150 300 600
MG/KG MG/KG MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (10) (10) (10) (10) (10) (10)
Inflammation, Chronic 5 [1.0] 6 [1.0] 3 [1.0] 4 [1.0] 8 [1.0] 10 [1.0]
Bronchiole, Bronchus, Hyperplasia, Lymphoid 1 [2.0]
Nose (10) (10) (10) (10) (10) (10)
Olfactory Epithelium, Degeneration 1 [1.0] 2 [1.0] 10 [1.6] 10 [2.1]
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Harderian Gland (10) (10)
Hyperplasia, Focal 1 [1.0]
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (10) (10) (10) (10) (10) (10)
Infiltration Cellular, Lymphocyte 1 [1.0] 3 [1.0]
Cortex, Renal Tubule, Mineralization 2 [1.0] 1 [1.0] 4 [1.0] 4 [1.0] 1 [1.0] 1 [1.0]
Medulla, Renal Tubule, Mineralization 1 [1.0]
Papilla, Renal Tubule, Mineralization 3 [1.0] 4 [1.0] 6 [1.0] 7 [1.0] 9 [1.0] 7 [1.0]
Renal Tubule, Regeneration 1 [1.0] 2 [1.0] 1 [1.0] 1 [1.0] 3 [1.0] 6 [1.0]
Renal Tubule, Epithelium, Regeneration 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 4
NTP Experiment-Test: 60946-01 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: 09:17:23
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS 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
Survivors
Terminal Sacrifice 10 10 10 10 10 10
Animals Examined Microscopically 10 10 10 10 10 10
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Esophagus (10) (10)
Inflammation, Chronic 1 [1.0]
Intestine Large, Rectum (10) (10)
Parasite Metazoan 1
Liver (10) (10) (10) (10) (10) (10)
Angiectasis, Focal 2 [1.5]
Basophilic Focus 6 9 6
Cholangiofibrosis 10 [2.6]
Clear Cell Focus 3 1 1
Eosinophilic Focus 1 10 10
Hepatodiaphragmatic Nodule 1 3 1 3
Inflammation, Chronic 1 [1.0] 2 [1.0] 1 [1.0] 1 [1.0] 3 [1.0]
Mixed Cell Focus 1 9 10 8
Bile Duct, Hyperplasia 10 [1.0] 10 [1.0] 10 [1.0] 10 [2.0] 10 [2.0]
Centrilobular, Vacuolization Cytoplasmic 1 [1.0]
Hepatocyte, Hypertrophy 10 [1.0] 10 [2.0] 10 [3.0] 10 [4.0]
Oval Cell, Hyperplasia 10 [1.0] 10 [1.1] 10 [2.0] 10 [3.0] 10 [3.0]
Periportal, Infiltration Cellular, Histiocyte 10 [1.0] 10 [1.1] 10 [2.0] 10 [2.0] 10 [2.0]
Periportal, Inflammation, Chronic 10 [1.0] 10 [1.0] 10 [2.0] 10 [2.0] 10 [2.0]
Pancreas (10) (10)
Acinus, Atrophy 1 [1.0]
Salivary Glands (10) (10) (10) (10) (10) (10)
Submandibular Gland, Cytoplasmic Alteration 10 [1.0] 10 [1.0] 10 [2.0] 10 [2.0]
Stomach, Glandular (10) (10) (10) (10) (10) (10)
Mineralization 1 [1.0]
Epithelium, Glands, Atrophy 2 [1.0] 10 [1.0] 10 [1.7] 10 [2.2]
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (10) (10)
Infiltration Cellular, Mononuclear Cell 2 [1.0] 3 [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: 60946-01 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: 09:17:23
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 MG/KG 37.5 75 150 300 600
MG/KG MG/KG MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM - CONT
Myocardium, Infiltration Cellular,
Mononuclear Cell 6 [1.0] 3 [1.0]
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Pituitary Gland (10) (10) (10) (10) (10) (10)
Pars Distalis, Chromophobe Cell, Hypertrophy 10 [1.8] 10 [1.6]
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Epididymis (10) (10) (10) (10) (10) (10)
Hypospermia 1 [4.0]
Bilateral, Hypospermia 10 [3.4] 10 [4.0]
Testes (10) (10) (10) (10) (10) (10)
Bilateral, Germinal Epithelium, Degeneration 10 [3.9] 10 [4.0]
Germinal Epithelium, Degeneration 1 [4.0] 2 [2.5]
Germinal Epithelium, Mineralization 1 [1.0]
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (10) (10) (10) (10) (10) (10)
Hyperplasia 4 [1.0] 3 [1.0] 10 [1.0] 10 [2.0]
Lymph Node (3) (3)
Pancreatic, Hyperplasia, Lymphoid 2 [2.0] 3 [2.3]
Pancreatic, Infiltration Cellular, Histiocyte 3 [2.7] 3 [2.7]
Lymph Node, Mesenteric (10) (10) (10) (10) (7) (10)
Hyperplasia, Lymphoid 1 [1.0] 2 [2.0] 2 [2.0]
Infiltration Cellular, Histiocyte 1 [1.0] 1 [3.0] 1 [3.0]
____________________________________________________________________________________________________________________________________
INTEGUMENTARY 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 6
NTP Experiment-Test: 60946-01 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: 09:17:23
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 MG/KG 37.5 75 150 300 600
MG/KG MG/KG MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
None
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
None
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (10) (10) (10) (10) (10) (10)
Inflammation, Chronic 5 [1.0] 3 [1.0] 6 [1.0] 7 [1.0] 6 [1.0] 8 [1.0]
Inflammation, Granulomatous 1 [1.0] 4 [1.3]
Nose (10) (10) (10) (10) (10) (10)
Inflammation, Chronic 2 [1.0]
Olfactory Epithelium, Degeneration 9 [1.3] 10 [2.1]
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
None
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (10) (10) (10) (10) (10) (10)
Infiltration Cellular, Lymphocyte 1 [1.0] 1 [1.0] 2 [1.0] 7 [1.0]
Cortex, Renal Tubule, Pigmentation 10 [1.0] 10 [1.0] 10 [2.0]
Medulla, Renal Tubule, Mineralization 1 [1.0]
Papilla, Renal Tubule, Mineralization 4 [1.0] 2 [1.0] 2 [1.0] 8 [1.0] 10 [1.0] 10 [1.9]
Renal Tubule, Cyst 1 [1.0]
Renal Tubule, Regeneration 7 [1.0] 7 [1.0] 10 [1.0] 10 [1.0] 10 [1.0] 8 [1.1]
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
------------------------------------------------------------
---------- END OF REPORT ----------
------------------------------------------------------------