TDMS Study 05121-99 Pathology Tables
INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)
SCOPOLAMINE HYDROBROMIDE TRIHYDRATE
NTP Experiment-Test: 05121-99 Report: PEIRPT05
Study Type: CHRONIC Date: 03/15/95
Route: GAVAGE Time: 17:21:13
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 NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC SCOPOLAMINE HYDROBROMIDE TRIHYDRATE Date: 03/15/95
Route: GAVAGE Time: 17:21:13
____________________________________________________________________________________________________________________________________
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
Intestine Small, Jejunum (51) (50)
Carcinoma 1 (2%)
Liver (51) (50)
Hemangiosarcoma, Multiple 1 (2%)
Hepatocellular Carcinoma 7 (14%)
Hepatocellular Carcinoma, Multiple 1 (2%)
Hepatocellular Adenoma 10 (20%) 3 (6%)
Hepatocellular Adenoma, Multiple 5 (10%)
Hepatocholangiocarcinoma 1 (2%)
Histiocytic Sarcoma 1 (2%) 1 (2%)
Bile Duct, Carcinoma 1 (2%)
Mesentery (7) (2)
Carcinoma, Metastatic, Liver 1 (14%)
Histiocytic Sarcoma 1 (50%)
Pancreas (51) (50)
Carcinoma, Metastatic, Liver 1 (2%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (51) (50)
Carcinoma, Metastatic, Liver 1 (2%)
Hepatocholangiocarcinoma, Metastatic, Liver 1 (2%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (51) (49)
Adrenal Medulla (51) (49)
Pheochromocytoma Malignant 1 (2%)
Pheochromocytoma Benign 1 (2%)
Pituitary Gland (50) (46)
Page 2
NTP Experiment-Test: 05121-99 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC SCOPOLAMINE HYDROBROMIDE TRIHYDRATE Date: 03/15/95
Route: GAVAGE Time: 17:21:13
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 MG/KG RTD
0 MG/KG
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM - cont
Pars Distalis, Adenoma 4 (8%)
Pars Intermedia, Adenoma 1 (2%)
Thyroid Gland (51) (50)
Follicular Cell, Adenoma 3 (6%) 1 (2%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Ovary (51) (50)
Cystadenoma 3 (6%)
Hemangiosarcoma 1 (2%)
Histiocytic Sarcoma 1 (2%)
Uterus (51) (50)
Adenoma 1 (2%)
Hemangiosarcoma 1 (2%)
Hemangiosarcoma, Metastatic, Ovary 1 (2%)
Histiocytic Sarcoma 2 (4%)
Polyp Stromal 1 (2%)
Sarcoma Stromal 1 (2%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (51) (50)
Histiocytic Sarcoma 1 (2%) 1 (2%)
Lymph Node (6)
Bronchial, Carcinoma, Metastatic, Liver 1 (17%)
Bronchial, Hepatocholangiocarcinoma,
Metastatic, Liver 1 (17%)
Mediastinal, Carcinoma, Metastatic, Liver 1 (17%)
Mediastinal, Hepatocholangiocarcinoma,
Metastatic, Liver 1 (17%)
Mediastinal, Histiocytic Sarcoma 1 (17%)
Lymph Node, Mandibular (50) (50)
Lymph Node, Mesenteric (50) (44)
Histiocytic Sarcoma 1 (2%)
Lymph Node, Mediastinal (2)
Histiocytic Sarcoma 1 (50%)
Spleen (51) (50)
Hemangiosarcoma 1 (2%)
Histiocytic Sarcoma 1 (2%)
Thymus (48) (45)
Page 3
NTP Experiment-Test: 05121-99 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC SCOPOLAMINE HYDROBROMIDE TRIHYDRATE Date: 03/15/95
Route: GAVAGE Time: 17:21:13
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 MG/KG RTD
0 MG/KG
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - cont
Alveolar/Bronchiolar Carcinoma, Metastatic,
Lung 1 (2%)
Hepatocholangiocarcinoma, Metastatic, Liver 1 (2%)
Histiocytic Sarcoma 1 (2%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (51) (50)
Carcinoma 1 (2%)
Skin (51) (50)
Subcutaneous Tissue, Fibrosarcoma 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (51) (50)
Hepatocholangiocarcinoma, Metastatic, Liver 1 (2%)
Skeletal Muscle (1) (2)
Hepatocholangiocarcinoma, Metastatic, Liver 1 (100%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
None
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (51) (50)
Alveolar/Bronchiolar Adenoma 3 (6%) 3 (6%)
Alveolar/Bronchiolar Carcinoma 1 (2%) 1 (2%)
Alveolar/Bronchiolar Carcinoma, Multiple 2 (4%)
Carcinoma, Metastatic, Harderian Gland 1 (2%)
Carcinoma, Metastatic, Liver 1 (2%)
Hemangiosarcoma, Metastatic, Ovary 1 (2%)
Hepatocellular Carcinoma, Metastatic, Liver 1 (2%)
Hepatocholangiocarcinoma, Metastatic, Liver 1 (2%)
Histiocytic Sarcoma 1 (2%) 1 (2%)
Mediastinum, Alveolar/Bronchiolar Carcinoma,
Metastatic, Lung 1 (2%)
____________________________________________________________________________________________________________________________________
Page 4
NTP Experiment-Test: 05121-99 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC SCOPOLAMINE HYDROBROMIDE TRIHYDRATE Date: 03/15/95
Route: GAVAGE Time: 17:21:13
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 MG/KG RTD
0 MG/KG
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Harderian Gland (17) (24)
Adenoma 1 (6%) 3 (13%)
Carcinoma 2 (12%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (51) (50)
Carcinoma, Metastatic, Liver 1 (2%)
Hepatocholangiocarcinoma, Metastatic, Liver 1 (2%)
Histiocytic Sarcoma 1 (2%)
Urinary Bladder (50) (50)
____________________________________________________________________________________________________________________________________
SYSTEMIC LESIONS
Multiple Organs *(51) *(50)
Histiocytic Sarcoma 1 (2%) 2 (4%)
Lymphoma Malignant Lymphocytic 2 (4%)
Lymphoma Malignant Mixed 7 (14%) 2 (4%)
____________________________________________________________________________________________________________________________________
* Number of animals with any tissue examined microscopically
Page 5
NTP Experiment-Test: 05121-99 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC SCOPOLAMINE HYDROBROMIDE TRIHYDRATE Date: 03/15/95
Route: GAVAGE Time: 17:21:13
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 MG/KG RTD
0 MG/KG
____________________________________________________________________________________________________________________________________
TUMOR SUMMARY
Total Animals with Primary Neoplasms (b) 40 19
Total Primary Neoplasms 62 20
Total Animals with Benign Neoplasms 24 12
Total Benign Neoplasms 31 12
Total Animals with Malignant Neoplasms 26 8
Total Malignant Neoplasms 31 8
Total Animals with Metastatic Neoplasms 5 1
Total Metastatic Neoplasm 19 2
Total Animals with Malignant Neoplasms
Uncertain Primary Site
Total Animals with Neoplasms Uncertain-
Benign or Malignant
Total Uncertain Neoplasms
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
b Primary tumors: all tumors except metastatic tumors
Page 6
NTP Experiment-Test: 05121-99 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC SCOPOLAMINE HYDROBROMIDE TRIHYDRATE Date: 03/15/95
Route: GAVAGE Time: 17:21:13
____________________________________________________________________________________________________________________________________
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
Intestine Small, Duodenum (50) (50)
Adenoma 1 (2%)
Intestine Small, Ileum (49) (49)
Liver (50) (50)
Hemangioma 1 (2%)
Hemangiosarcoma, Metastatic, Skin 1 (2%)
Hepatocellular Carcinoma 6 (12%) 2 (4%)
Hepatocellular Adenoma 10 (20%) 3 (6%)
Hepatocellular Adenoma, Multiple 16 (32%)
Histiocytic Sarcoma 3 (6%)
Ito Cell Tumor NOS, Multiple 1 (2%)
Mesentery (4) (1)
Pancreas (50) (50)
Tooth (14) (2)
Odontoma 1 (7%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (50) (50)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Medulla (49) (50)
Pheochromocytoma Benign 1 (2%)
Islets, Pancreatic (50) (50)
Adenoma 3 (6%)
Pituitary Gland (48) (48)
Pars Intermedia, Adenoma 1 (2%)
____________________________________________________________________________________________________________________________________
Page 7
NTP Experiment-Test: 05121-99 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC SCOPOLAMINE HYDROBROMIDE TRIHYDRATE Date: 03/15/95
Route: GAVAGE Time: 17:21:13
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 MG/KG RTD
0 MG/KG
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Testes (50) (50)
Interstitial Cell, Adenoma 2 (4%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (50) (50)
Hemangiosarcoma, Metastatic, Skin 1 (2%)
Lymph Node (2)
Lymph Node, Mandibular (49) (50)
Lymph Node, Mesenteric (48) (50)
Histiocytic Sarcoma 3 (6%)
Lymph Node, Mediastinal (1)
Spleen (50) (50)
Hemangiosarcoma 1 (2%)
Hemangiosarcoma, Metastatic, Skin 1 (2%)
Histiocytic Sarcoma 2 (4%)
Thymus (42) (45)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Skin (50) (50)
Subcutaneous Tissue, Hemangiosarcoma 1 (2%)
Subcutaneous Tissue, Sarcoma 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
None
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
None
____________________________________________________________________________________________________________________________________
Page 8
NTP Experiment-Test: 05121-99 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC SCOPOLAMINE HYDROBROMIDE TRIHYDRATE Date: 03/15/95
Route: GAVAGE Time: 17:21:13
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 MG/KG RTD
0 MG/KG
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (50)
Alveolar/Bronchiolar Adenoma 11 (22%) 8 (16%)
Alveolar/Bronchiolar Adenoma, Multiple 1 (2%)
Alveolar/Bronchiolar Carcinoma 2 (4%) 2 (4%)
Alveolar/Bronchiolar Carcinoma, Multiple 1 (2%)
Hepatocellular Carcinoma, Metastatic, Liver 3 (6%)
Histiocytic Sarcoma 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Harderian Gland (16) (22)
Adenoma 3 (19%) 2 (9%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (50)
Histiocytic Sarcoma 1 (2%)
Renal Tubule, Carcinoma 2 (4%)
Urinary Bladder (50) (50)
____________________________________________________________________________________________________________________________________
SYSTEMIC LESIONS
Multiple Organs *(50) *(50)
Histiocytic Sarcoma 3 (6%)
Leukemia Lymphocytic 1 (2%)
Lymphoma Malignant Lymphocytic 1 (2%) 1 (2%)
Lymphoma Malignant Mixed 3 (6%)
____________________________________________________________________________________________________________________________________
* Number of animals with any tissue examined microscopically
Page 9
NTP Experiment-Test: 05121-99 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC SCOPOLAMINE HYDROBROMIDE TRIHYDRATE Date: 03/15/95
Route: GAVAGE Time: 17:21:13
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 MG/KG RTD
0 MG/KG
____________________________________________________________________________________________________________________________________
TUMOR SUMMARY
Total Animals with Primary Neoplasms (b) 43 19
Total Primary Neoplasms 69 23
Total Animals with Benign Neoplasms 36 14
Total Benign Neoplasms 48 16
Total Animals with Malignant Neoplasms 17 6
Total Malignant Neoplasms 20 7
Total Animals with Metastatic Neoplasms 4
Total Metastatic Neoplasm 6
Total Animals with Malignant Neoplasms
Uncertain Primary Site
Total Animals with Neoplasms Uncertain-
Benign or Malignant 1
Total Uncertain Neoplasms 1
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
b Primary tumors: all tumors except metastatic tumors
Page 10
------------------------------------------------------------
---------- END OF REPORT ----------
------------------------------------------------------------