TDMS Study 05121-05 Pathology Tables
NTP Experiment-Test: 05121-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC SCOPOLAMINE HYDROBROMIDE TRIHYDRATE Date: 04/03/96
Route: GAVAGE Time: 21:23:04
Facility: Battelle Columbus Laboratory
Chemical CAS #: 6533-68-2
Lock Date: 05/14/92
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: 05121-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC SCOPOLAMINE HYDROBROMIDE TRIHYDRATE Date: 04/03/96
Route: GAVAGE Time: 21:23:04
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE O MG/KG 1 MG/KG 5 MG/KG 25 MG/KG
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially in Study 60 60 60 60
Scheduled Sacrifice 10 10 10
Early Deaths
Moribund Sacrifice 13 10 6 7
Natural Death 3 15 16 16
Dosing Accident 2 2 5
Accidently Killed 16
Survivors
Terminal Sacrifice 34 17 26 22
Animals Examined Microscopically 60 60 60 60
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Liver (60) (60) (60) (60)
Hepatocellular Adenoma 1 (2%)
Tongue (1)
Squamous Cell Carcinoma 1 (100%)
Tooth (1)
Gingiva, Squamous Cell Carcinoma 1 (100%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (60) (60) (60) (60)
Schwannoma NOS 1 (2%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (60) (60) (60) (60)
Adenoma 2 (3%) 1 (2%)
Adrenal Medulla (60) (60) (60) (60)
Pheochromocytoma Benign 1 (2%) 1 (2%) 1 (2%)
Bilateral, Pheochromocytoma Malignant 1 (2%)
Islets, Pancreatic (60) (60) (59) (60)
Adenoma 1 (2%)
Pituitary Gland (60) (60) (60) (60)
Pars Distalis, Adenoma 21 (35%) 13 (22%) 15 (25%) 10 (17%)
Thyroid Gland (60) (60) (60) (60)
Bilateral, C-Cell, Adenoma 1 (2%)
C-Cell, Adenoma 2 (3%) 1 (2%) 2 (3%) 1 (2%)
C-Cell, Carcinoma 2 (3%) 1 (2%)
Page 2
NTP Experiment-Test: 05121-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC SCOPOLAMINE HYDROBROMIDE TRIHYDRATE Date: 04/03/96
Route: GAVAGE Time: 21:23:04
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE O MG/KG 1 MG/KG 5 MG/KG 25 MG/KG
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM - cont
Follicular Cell, Adenoma 1 (2%) 3 (5%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Clitoral Gland (59) (60) (58) (60)
Adenoma 3 (5%) 2 (3%) 2 (3%) 1 (2%)
Bilateral, Adenoma 1 (2%)
Uterus (60) (60) (60) (60)
Adenoma 1 (2%)
Polyp Stromal 7 (12%) 1 (2%) 4 (7%) 4 (7%)
Schwannoma NOS 1 (2%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (60) (60) (60) (60)
Pheochromocytoma Malignant, Metastatic,
Adrenal Medulla 1 (2%)
Lymph Node (2) (2) (2)
Lymph Node, Mandibular (60) (60) (60) (60)
Histiocytic Sarcoma 1 (2%)
Lymph Node, Mesenteric (60) (59) (60) (60)
Histiocytic Sarcoma 1 (2%)
Spleen (60) (60) (60) (60)
Histiocytic Sarcoma 1 (2%) 1 (2%)
Pheochromocytoma Malignant, Metastatic,
Adrenal Medulla 1 (2%)
Thymus (57) (59) (60) (60)
Thymoma Malignant 1 (2%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (60) (60) (60) (58)
Adenoma 1 (2%)
Carcinoma 1 (2%) 1 (2%) 1 (2%)
Fibroadenoma 20 (33%) 8 (13%) 14 (23%) 13 (22%)
Fibroadenoma, Multiple 9 (15%) 2 (3%) 5 (8%) 3 (5%)
Skin (60) (60) (60) (60)
Keratoacanthoma 1 (2%) 1 (2%)
Sarcoma 1 (2%)
Page 3
NTP Experiment-Test: 05121-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC SCOPOLAMINE HYDROBROMIDE TRIHYDRATE Date: 04/03/96
Route: GAVAGE Time: 21:23:04
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE O MG/KG 1 MG/KG 5 MG/KG 25 MG/KG
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM - cont
Sebaceous Gland, Adenoma 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Skeletal Muscle (1)
Rhabdomyosarcoma 1 (100%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (60) (60) (60) (60)
Peripheral Nerve (5) (6) (5) (2)
Spinal Cord (2) (4) (5) (2)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (60) (60) (60) (60)
Pheochromocytoma Malignant, Metastatic,
Adrenal Medulla 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (2) (3) (2)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (60) (60) (60) (60)
Urinary Bladder (60) (60) (59) (60)
____________________________________________________________________________________________________________________________________
SYSTEMIC LESIONS
Multiple Organs *(60) *(60) *(60) *(60)
Histiocytic Sarcoma 1 (2%) 1 (2%)
Leukemia Mononuclear 20 (33%) 6 (10%) 13 (22%) 4 (7%)
____________________________________________________________________________________________________________________________________
* Number of animals with any tissue examined microscopically
Page 4
NTP Experiment-Test: 05121-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC SCOPOLAMINE HYDROBROMIDE TRIHYDRATE Date: 04/03/96
Route: GAVAGE Time: 21:23:04
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE O MG/KG 1 MG/KG 5 MG/KG 25 MG/KG
____________________________________________________________________________________________________________________________________
TUMOR SUMMARY
Total Animals with Primary Neoplasms (b) 50 23 40 33
Total Primary Neoplasms 94 37 65 45
Total Animals with Benign Neoplasms 39 19 33 30
Total Benign Neoplasms 68 28 47 39
Total Animals with Malignant Neoplasms 23 9 16 6
Total Malignant Neoplasms 24 9 18 6
Total Animals with Metastatic Neoplasms 1
Total Metastatic Neoplasm 3
Total Animals with Malignant Neoplasms
Uncertain Primary Site
Total Animals with Neoplasms Uncertain-
Benign or Malignant 2
Total Uncertain Neoplasms 2
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
b Primary tumors: all tumors except metastatic tumors
Page 5
NTP Experiment-Test: 05121-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC SCOPOLAMINE HYDROBROMIDE TRIHYDRATE Date: 04/03/96
Route: GAVAGE Time: 21:23:04
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE O MG/KG 1 MG/KG 5 MG/KG 25 MG/KG
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially in Study 60 60 60 60
Scheduled Sacrifice 10 10 10 10
Early Deaths
Moribund Sacrifice 23 30 20 17
Natural Death 5 4 7 4
Dosing Accident 2 2 1 1
Survivors
Terminal Sacrifice 20 14 22 28
Animals Examined Microscopically 60 60 60 60
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Esophagus (60) (60) (60) (60)
Intestine Large, Colon (60) (60) (60) (60)
Leiomyoma 1 (2%)
Liver (60) (60) (60) (60)
Hepatocellular Carcinoma 1 (2%) 1 (2%)
Hepatocellular Adenoma 1 (2%) 2 (3%) 2 (3%) 2 (3%)
Osteosarcoma, Metastatic, Uncertain Primary
Site 1 (2%)
Mesentery (7) (15) (24) (15)
Carcinoma, Metastatic, Islets, Pancreatic 1 (7%)
Osteosarcoma, Metastatic, Uncertain Primary
Site 1 (4%)
Pancreas (60) (60) (60) (60)
Osteosarcoma, Metastatic, Uncertain Primary
Site 1 (2%)
Acinus, Adenoma 1 (2%)
Salivary Glands (60) (59) (60) (59)
Schwannoma Malignant 1 (2%)
Tongue (1)
Squamous Cell Papilloma 1 (100%)
Tooth (1) (1)
Gingiva, Squamous Cell Carcinoma 1 (100%) 1 (100%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (60) (60) (60) (60)
Schwannoma NOS 1 (2%)
____________________________________________________________________________________________________________________________________
Page 6
NTP Experiment-Test: 05121-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC SCOPOLAMINE HYDROBROMIDE TRIHYDRATE Date: 04/03/96
Route: GAVAGE Time: 21:23:04
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE O MG/KG 1 MG/KG 5 MG/KG 25 MG/KG
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (60) (60) (60) (60)
Adenoma 1 (2%)
Adrenal Medulla (60) (60) (60) (60)
Pheochromocytoma Benign 8 (13%) 11 (18%) 9 (15%) 9 (15%)
Bilateral, Pheochromocytoma Benign 3 (5%) 2 (3%) 3 (5%) 1 (2%)
Islets, Pancreatic (60) (60) (60) (60)
Adenoma 3 (5%) 2 (3%) 1 (2%)
Carcinoma 1 (2%)
Parathyroid Gland (55) (55) (55) (59)
Adenoma 1 (2%)
Pituitary Gland (59) (58) (60) (60)
Pars Distalis, Adenoma 19 (32%) 17 (29%) 14 (23%) 11 (18%)
Pars Intermedia, Adenoma 1 (2%)
Thyroid Gland (60) (60) (60) (60)
Bilateral, C-Cell, Adenoma 1 (2%)
C-Cell, Adenoma 1 (2%) 4 (7%) 2 (3%) 2 (3%)
C-Cell, Carcinoma 1 (2%) 3 (5%)
Follicular Cell, Adenoma 3 (5%) 2 (3%) 1 (2%)
Follicular Cell, Carcinoma 1 (2%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Epididymis (60) (60) (60) (60)
Osteosarcoma, Metastatic, Uncertain Primary
Site 1 (2%)
Preputial Gland (60) (60) (58) (60)
Adenoma 3 (5%) 1 (2%) 4 (7%) 2 (3%)
Carcinoma 1 (2%)
Testes (60) (60) (60) (60)
Osteosarcoma, Metastatic, Uncertain Primary
Site 1 (2%)
Bilateral, Interstitial Cell, Adenoma 43 (72%) 36 (60%) 41 (68%) 47 (78%)
Interstitial Cell, Adenoma 9 (15%) 14 (23%) 14 (23%) 6 (10%)
____________________________________________________________________________________________________________________________________
Page 7
NTP Experiment-Test: 05121-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC SCOPOLAMINE HYDROBROMIDE TRIHYDRATE Date: 04/03/96
Route: GAVAGE Time: 21:23:04
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE O MG/KG 1 MG/KG 5 MG/KG 25 MG/KG
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Lymph Node (5) (8) (5) (9)
Mediastinal, Osteosarcoma, Metastatic,
Uncertain Primary Site 1 (20%)
Lymph Node, Mandibular (60) (59) (60) (58)
Lymph Node, Mesenteric (59) (60) (60) (60)
Spleen (60) (60) (60) (60)
Fibroma 1 (2%)
Hemangiosarcoma 1 (2%)
Osteosarcoma, Metastatic, Uncertain Primary
Site 1 (2%)
Thymus (55) (55) (58) (57)
Osteosarcoma, Metastatic, Uncertain Primary
Site 1 (2%)
Thymoma Malignant 1 (2%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (55) (57) (57) (56)
Fibroadenoma 3 (5%) 8 (14%) 3 (5%) 2 (4%)
Fibroadenoma, Multiple 1 (2%)
Skin (60) (60) (60) (59)
Basal Cell Adenoma 1 (2%)
Fibroma 4 (7%) 3 (5%) 3 (5%) 2 (3%)
Fibroma, Multiple 1 (2%) 1 (2%)
Fibrous Histiocytoma 1 (2%)
Keratoacanthoma 3 (5%) 3 (5%) 3 (5%) 2 (3%)
Keratoacanthoma, Multiple 1 (2%)
Sarcoma 1 (2%)
Squamous Cell Carcinoma 1 (2%)
Squamous Cell Papilloma 3 (5%) 2 (3%)
Sebaceous Gland, Adenoma 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (60) (60) (60) (60)
Osteosarcoma 1 (2%) 1 (2%) 1 (2%) 1 (2%)
Skeletal Muscle (1) (1) (1)
Carcinoma, Metastatic, Islets, Pancreatic 1 (100%)
Osteosarcoma, Metastatic, Uncertain Primary
Site 1 (100%)
Sarcoma 1 (100%)
____________________________________________________________________________________________________________________________________
Page 8
NTP Experiment-Test: 05121-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC SCOPOLAMINE HYDROBROMIDE TRIHYDRATE Date: 04/03/96
Route: GAVAGE Time: 21:23:04
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE O MG/KG 1 MG/KG 5 MG/KG 25 MG/KG
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (60) (60) (60) (60)
Astrocytoma NOS 1 (2%)
Spinal Cord (9) (7) (6) (5)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (60) (60) (60) (60)
Alveolar/Bronchiolar Adenoma 1 (2%)
Alveolar/Bronchiolar Carcinoma 1 (2%)
Osteosarcoma, Metastatic, Bone 1 (2%) 1 (2%)
Squamous Cell Carcinoma, Metastatic, Tooth 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (1) (1) (1) (1)
Harderian Gland (1) (1)
Adenoma 1 (100%)
Zymbal's Gland (2) (2) (2)
Carcinoma 2 (100%) 2 (100%) 2 (100%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (60) (60) (60) (60)
Fibroma 1 (2%)
Osteosarcoma, Metastatic, Uncertain Primary
Site 1 (2%)
Renal Tubule, Adenoma 1 (2%)
Renal Tubule, Carcinoma 1 (2%) 1 (2%)
Urinary Bladder (60) (60) (60) (60)
____________________________________________________________________________________________________________________________________
SYSTEMIC LESIONS
Multiple Organs *(60) *(60) *(60) *(60)
Leukemia Mononuclear 34 (57%) 21 (35%) 26 (43%) 24 (40%)
Mesothelioma NOS 1 (2%) 1 (2%) 4 (7%) 3 (5%)
____________________________________________________________________________________________________________________________________
* Number of animals with any tissue examined microscopically
Page 9
NTP Experiment-Test: 05121-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC SCOPOLAMINE HYDROBROMIDE TRIHYDRATE Date: 04/03/96
Route: GAVAGE Time: 21:23:04
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE O MG/KG 1 MG/KG 5 MG/KG 25 MG/KG
____________________________________________________________________________________________________________________________________
TUMOR SUMMARY
Total Animals with Primary Neoplasms (b) 58 57 59 57
Total Primary Neoplasms 155 140 143 126
Total Animals with Benign Neoplasms 57 57 58 57
Total Benign Neoplasms 110 112 102 93
Total Animals with Malignant Neoplasms 39 27 30 29
Total Malignant Neoplasms 44 27 35 30
Total Animals with Metastatic Neoplasms 1 2 1 1
Total Metastatic Neoplasm 1 3 10 1
Total Animals with Malignant Neoplasms 1
Uncertain Primary Site
Total Animals with Neoplasms Uncertain-
Benign or Malignant 1 1 6 3
Total Uncertain Neoplasms 3 4 17 8
____________________________________________________________________________________________________________________________________
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 ----------
------------------------------------------------------------