TDMS Study 05121-99 Pathology Tables
INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)
SCOPOLAMINE HYDROBROMIDE TRIHYDRATE
NTP Experiment-Test: 05121-99 Report: PEIRPT03
Study Type: CHRONIC Date: 03/15/95
Route: GAVAGE Time: 17:07:00
05121/07 - 05121/08 COMPARISON
Facility: BATTELLE COLUMBUS LABORATORY
Chemical CAS #: 6533-68-2
Lock Date: 06/01/92
Cage Range: All
Reasons For Removal: 25022 Accidently Killed 25018 Dosing Accident
25019 Moribund Sacrifice 25020 Natural Death
25021 Terminal Sacrifice
Removal Date Range: All
Treatment Groups: Include 001 0 MG/KG
Include 002 0 MG/KG
Include 003 RTD 0 MG/KG
Include 005 RTD 0 MG/KG
a Number of animals examined microscopically at site and number of animals with lesion
Page 1
NTP Experiment-Test: 05121-99 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC SCOPOLAMINE HYDROBROMIDE TRIHYDRATE Date: 03/15/95
Route: GAVAGE Time: 17:07:00
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 MG/KG RTD
0 MG/KG
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 70 60
Early Deaths
Natural Death 7 1
Moribund Sacrifice 9 2
Dosing Accident 2
Survivors
Terminal Sacrifice 33 47
Animals Examined Microscopically 51 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Esophagus (51) (50)
Perforation 1 (2%)
Periesophageal Tissue, Inflammation,
Suppurative 3 (6%)
Intestine Small, Jejunum (51) (50)
Hyperplasia, Lymphoid 2 (4%)
Liver (51) (50)
Angiectasis 1 (2%) 1 (2%)
Basophilic Focus 1 (2%) 1 (2%)
Eosinophilic Focus 17 (33%)
Hyperplasia, Lymphoid 1 (2%)
Inflammation, Chronic Active 1 (2%)
Mixed Cell Focus 6 (12%) 2 (4%)
Centrilobular, Necrosis 1 (2%)
Serosa, Pigmentation, Hemosiderin 1 (2%)
Mesentery (7) (2)
Fat, Necrosis 6 (86%)
Pancreas (51) (50)
Atrophy 5 (10%)
Hypertrophy 1 (2%)
Acinus, Hyperplasia, Focal 3 (6%)
Duct, Cyst 2 (4%)
Salivary Glands (51) (50)
Duct, Hyperplasia 1 (2%)
Stomach, Forestomach (51) (50)
Erosion 1 (2%)
Hyperplasia, Focal 6 (12%) 29 (58%)
Infiltration Cellular, Mast Cell 1 (2%)
Stomach, Glandular (51) (50)
Erosion 2 (4%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 2
NTP Experiment-Test: 05121-99 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC SCOPOLAMINE HYDROBROMIDE TRIHYDRATE Date: 03/15/95
Route: GAVAGE Time: 17:07:00
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 MG/KG RTD
0 MG/KG
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Blood Vessel (51) (50)
Aorta, Inflammation, Chronic Active 1 (2%)
Heart (51) (50)
Inflammation, Chronic Active 1 (2%)
Mineralization 2 (4%) 2 (4%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (51) (49)
Hyperplasia 1 (2%) 2 (4%)
Hypertrophy 1 (2%)
Adrenal Medulla (51) (49)
Hyperplasia 3 (6%)
Islets, Pancreatic (51) (50)
Hyperplasia 1 (2%)
Pituitary Gland (50) (46)
Pars Distalis, Hyperplasia 24 (48%) 1 (2%)
Pars Intermedia, Hyperplasia 1 (2%)
Thyroid Gland (51) (50)
Inflammation, Chronic Active 1 (2%) 1 (2%)
Follicular Cell, Hyperplasia 16 (31%) 2 (4%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Ovary (51) (50)
Atrophy 1 (2%)
Cyst 16 (31%) 13 (26%)
Hemorrhage 1 (2%)
Uterus (51) (50)
Hyperplasia, Cystic 38 (75%) 16 (32%)
Inflammation, Chronic Active 1 (2%)
Inflammation, Suppurative 1 (2%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 3
NTP Experiment-Test: 05121-99 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC SCOPOLAMINE HYDROBROMIDE TRIHYDRATE Date: 03/15/95
Route: GAVAGE Time: 17:07:00
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 MG/KG RTD
0 MG/KG
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (51) (50)
Myelofibrosis 22 (43%) 7 (14%)
Erythroid Cell, Hyperplasia 3 (6%)
Myeloid Cell, Hyperplasia 9 (18%) 1 (2%)
Lymph Node, Mandibular (50) (50)
Hyperplasia, Lymphoid 1 (2%) 1 (2%)
Spleen (51) (50)
Depletion Lymphoid 2 (4%)
Hematopoietic Cell Proliferation 17 (33%) 3 (6%)
Hyperplasia, Lymphoid 3 (6%) 1 (2%)
Hyperplasia, Plasma Cell 1 (2%)
Thymus (48) (45)
Atrophy 3 (6%) 1 (2%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (51) (50)
Hyperplasia 1 (2%)
Skin (51) (50)
Inflammation, Chronic Active 1 (2%)
Ulcer 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
None
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (51) (50)
Infarct 1 (2%)
Neuron, Necrosis 1 (2%)
Peripheral Nerve (2)
Degeneration 2 (100%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (51) (50)
Infiltration Cellular, Histiocyte 2 (4%)
Inflammation, Chronic Active 1 (2%)
Alveolar Epithelium, Hyperplasia 1 (2%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 4
NTP Experiment-Test: 05121-99 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC SCOPOLAMINE HYDROBROMIDE TRIHYDRATE Date: 03/15/95
Route: GAVAGE Time: 17:07:00
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 MG/KG RTD
0 MG/KG
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (2)
Cornea, Inflammation, Chronic Active 2 (100%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (51) (50)
Cyst 1 (2%)
Infarct 1 (2%)
Nephropathy 23 (45%) 16 (32%)
Renal Tubule, Necrosis 1 (2%)
Renal Tubule, Necrosis, Acute 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 5
NTP Experiment-Test: 05121-99 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC SCOPOLAMINE HYDROBROMIDE TRIHYDRATE Date: 03/15/95
Route: GAVAGE Time: 17:07:00
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 MG/KG RTD
0 MG/KG
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 70 60
Early Deaths
Natural Death 5 1
Moribund Sacrifice 4
Survivors
Natural Death 1
Terminal Sacrifice 40 49
Animals Examined Microscopically 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Esophagus (50) (50)
Cyst 1 (2%)
Periesophageal Tissue, Inflammation,
Suppurative 1 (2%) 1 (2%)
Intestine Small, Jejunum (50) (50)
Hyperplasia, Lymphoid 1 (2%)
Liver (50) (50)
Basophilic Focus 3 (6%)
Clear Cell Focus 12 (24%) 1 (2%)
Eosinophilic Focus 21 (42%) 1 (2%)
Fatty Change 1 (2%)
Hematopoietic Cell Proliferation 2 (4%)
Inflammation, Chronic Active 1 (2%)
Mixed Cell Focus 5 (10%)
Necrosis 1 (2%) 1 (2%)
Bile Duct, Hyperplasia, Cystic 1 (2%)
Mesentery (4) (1)
Fibrosis 1 (100%)
Fat, Necrosis 2 (50%)
Pancreas (50) (50)
Atrophy 2 (4%)
Stomach, Forestomach (50) (50)
Hyperplasia, Focal 3 (6%) 38 (76%)
Stomach, Glandular (50) (50)
Dysplasia 1 (2%)
Tongue (1)
Mineralization 1 (100%)
Tooth (14) (2)
Dysplasia 13 (93%) 2 (100%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 6
NTP Experiment-Test: 05121-99 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC SCOPOLAMINE HYDROBROMIDE TRIHYDRATE Date: 03/15/95
Route: GAVAGE Time: 17:07:00
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 MG/KG RTD
0 MG/KG
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (50) (50)
Mineralization 2 (4%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (50) (50)
Accessory Adrenal Cortical Nodule 1 (2%) 2 (4%)
Hyperplasia 23 (46%) 14 (28%)
Capsule, Hyperplasia, Adenomatous 7 (14%) 6 (12%)
Adrenal Medulla (49) (50)
Inflammation, Chronic Active 1 (2%)
Islets, Pancreatic (50) (50)
Hyperplasia 29 (58%) 1 (2%)
Pituitary Gland (48) (48)
Pars Distalis, Hyperplasia 1 (2%)
Thyroid Gland (50) (50)
Follicular Cell, Hyperplasia 13 (26%) 1 (2%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Epididymis (50) (50)
Granuloma Sperm 1 (2%)
Preputial Gland (50) (50)
Inflammation, Chronic Active 1 (2%) 2 (4%)
Duct, Ectasia 47 (94%) 24 (48%)
Seminal Vesicle (50) (50)
Inflammation, Chronic Active 1 (2%)
Testes (50) (50)
Atrophy 2 (4%) 1 (2%)
Hypoplasia 1 (2%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (50) (50)
Myeloid Cell, Hyperplasia 1 (2%)
Lymph Node (2)
Mediastinal, Hyperplasia, Lymphoid 1 (50%)
Lymph Node, Mesenteric (48) (50)
a Number of animals examined microscopically at site and number of animals with lesion
Page 7
NTP Experiment-Test: 05121-99 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC SCOPOLAMINE HYDROBROMIDE TRIHYDRATE Date: 03/15/95
Route: GAVAGE Time: 17:07:00
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 MG/KG RTD
0 MG/KG
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - CONT
Hematopoietic Cell Proliferation 2 (4%)
Hyperplasia, Lymphoid 1 (2%)
Spleen (50) (50)
Angiectasis 1 (2%)
Hematopoietic Cell Proliferation 8 (16%) 2 (4%)
Hyperplasia, Lymphoid 1 (2%)
Thymus (42) (45)
Atrophy 6 (14%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Skin (50) (50)
Subcutaneous Tissue, Lymphangiectasis 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
None
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (50)
Neuron, Necrosis 1 (2%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (50)
Bronchiectasis, Focal 1 (2%)
Embolus 1 (2%)
Inflammation, Suppurative 1 (2%)
Alveolar Epithelium, Hyperplasia 8 (16%) 5 (10%)
Nose (50) (50)
Respiratory Epithelium, Inflammation,
Chronic Active 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Harderian Gland (16) (22)
Hyperplasia 1 (6%) 1 (5%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 8
NTP Experiment-Test: 05121-99 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC SCOPOLAMINE HYDROBROMIDE TRIHYDRATE Date: 03/15/95
Route: GAVAGE Time: 17:07:00
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 MG/KG RTD
0 MG/KG
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (50)
Cyst 6 (12%)
Inflammation, Chronic Active 2 (4%)
Nephropathy 48 (96%) 47 (94%)
Renal Tubule, Hyperplasia 1 (2%)
Urinary Bladder (50) (50)
Inflammation, Chronic Active 2 (4%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 9
------------------------------------------------------------
---------- END OF REPORT ----------
------------------------------------------------------------