TDMS Study 05108-02 Pathology Tables
INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)
PROMETHAZINE HYDROCHLORIDE
NTP Experiment-Test: 05108-02 Report: PEIRPT05
Study Type: CHRONIC Date: 09/14/94
Route: GAVAGE Time: 00:14:27
Facility: TSI Mason Research
Chemical CAS #: 58-33-3
Lock Date: None
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: 05108-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 09/14/94
Route: GAVAGE Time: 00:14:27
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE VEHICLE 3.75 7.5 15.0
FEMALE MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially in Study 60 60 60 60
Scheduled Sacrifice 10 10 9 9
Early Deaths
Moribund 10 7 9 6
Dead 1 1 1 3
Accident 2 1
Survivors
Terminal Sacrifice 37 42 39 41
Dead 2
Animals Examined Microscopically 60 60 60 60
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Esophagus (60) (59) (58) (59)
Squamous Cell Papilloma 1 (2%)
Gallbladder (56) (59) (56) (57)
Intestine Large, Colon (60) (59) (60) (60)
Intestine Large, Cecum (59) (59) (59) (58)
Intestine Small, Duodenum (58) (59) (60) (59)
Intestine Small, Jejunum (56) (59) (58) (57)
Intestine Small, Ileum (58) (59) (60) (58)
Liver (60) (60) (60) (60)
Hemangiosarcoma 1 (2%)
Hepatocellular Carcinoma 1 (2%) 1 (2%) 1 (2%) 2 (3%)
Hepatocellular Adenoma 2 (3%) 4 (7%) 6 (10%) 9 (15%)
Hepatocellular Adenoma, Multiple 1 (2%)
Histiocytic Sarcoma 2 (3%) 1 (2%) 2 (3%)
Mesentery (4) (1) (3) (2)
Fibroma 1 (25%)
Sarcoma 1 (100%) 1 (50%)
Pancreas (60) (59) (60) (59)
Sarcoma, Metastatic, Skin 1 (2%)
Salivary Glands (59) (60) (60) (59)
Stomach, Forestomach (60) (60) (60) (60)
Mast Cell Tumor Benign 1 (2%)
Squamous Cell Papilloma 1 (2%) 1 (2%) 1 (2%) 2 (3%)
Stomach, Glandular (59) (59) (60) (59)
____________________________________________________________________________________________________________________________________
Page 2
NTP Experiment-Test: 05108-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 09/14/94
Route: GAVAGE Time: 00:14:27
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE VEHICLE 3.75 7.5 15.0
FEMALE MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (60) (60) (59) (60)
Alveolar/Bronchiolar Carcinoma, Metastatic,
Lung 1 (2%)
Carcinoma, Metastatic, Harderian Gland 1 (2%)
Histiocytic Sarcoma 1 (2%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (60) (60) (60) (60)
Capsule, Adenoma 2 (3%) 1 (2%)
Islets, Pancreatic (59) (59) (60) (59)
Adenoma 1 (2%)
Pituitary Gland (56) (59) (59) (58)
Carcinoma 1 (2%)
Pars Distalis, Adenoma 5 (9%) 2 (3%) 4 (7%) 3 (5%)
Pars Distalis, Adenoma, Multiple 1 (2%)
Pars Intermedia, Adenoma 1 (2%)
Thyroid Gland (60) (60) (57) (60)
Carcinoma 1 (2%)
Bilateral, Follicular Cell, Adenoma 1 (2%)
Follicular Cell, Adenoma 4 (7%) 2 (3%) 1 (2%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Ovary (59) (59) (58) (58)
Adenoma, Tubular 1 (2%)
Cystadenoma 2 (3%) 2 (3%) 1 (2%)
Hemangioma 1 (2%)
Histiocytic Sarcoma 1 (2%)
Luteoma 1 (2%)
Uterus (60) (60) (60) (60)
Adenoma 1 (2%)
Histiocytic Sarcoma 1 (2%) 1 (2%)
Leiomyosarcoma 1 (2%) 1 (2%)
Polyp Stromal 1 (2%) 3 (5%) 3 (5%) 2 (3%)
____________________________________________________________________________________________________________________________________
Page 3
NTP Experiment-Test: 05108-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 09/14/94
Route: GAVAGE Time: 00:14:27
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE VEHICLE 3.75 7.5 15.0
FEMALE MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (60) (59) (60) (59)
Lymph Node (4) (7) (3) (2)
Lymph Node, Mandibular (58) (58) (58) (57)
Lymph Node, Mesenteric (56) (59) (58) (54)
Hemangioma 1 (2%)
Histiocytic Sarcoma 1 (2%) 1 (2%) 1 (2%)
Sarcoma, Metastatic, Skin 1 (2%)
Spleen (59) (59) (59) (60)
Hemangioma 1 (2%)
Hemangiosarcoma 1 (2%)
Histiocytic Sarcoma 1 (2%) 1 (2%) 2 (3%)
Thymus (52) (58) (55) (57)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (46) (47) (48) (51)
Adenocarcinoma 1 (2%)
Adenoma 1 (2%) 1 (2%)
Skin (60) (59) (60) (59)
Basosquamous Tumor Benign 1 (2%)
Subcutaneous Tissue, Fibrosarcoma 1 (2%)
Subcutaneous Tissue, Sarcoma 1 (2%) 2 (3%) 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (60) (60) (60) (60)
Osteosarcoma 1 (2%)
Skeletal Muscle (1) (2)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (60) (59) (60) (60)
Carcinoma, Metastatic, Pituitary Gland 1 (2%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (60) (60) (59) (60)
Alveolar/Bronchiolar Adenoma 8 (13%) 2 (3%) 2 (3%)
Alveolar/Bronchiolar Carcinoma 2 (3%)
Carcinoma, Metastatic, Harderian Gland 1 (2%) 1 (2%)
Carcinoma, Metastatic, Thyroid Gland 1 (2%)
Hepatocellular Carcinoma, Metastatic, Liver 1 (2%) 1 (2%)
Page 4
NTP Experiment-Test: 05108-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 09/14/94
Route: GAVAGE Time: 00:14:27
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE VEHICLE 3.75 7.5 15.0
FEMALE MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM - cont
Histiocytic Sarcoma 2 (3%) 2 (3%)
Osteosarcoma, Metastatic, Uncertain Primary
Site 1 (2%)
Mediastinum, Carcinoma, Metastatic, Lung 1 (2%)
Nose (57) (58) (58) (56)
Carcinoma, Metastatic, Harderian Gland 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Ear (1)
Sarcoma 1 (100%)
Harderian Gland (3) (5) (1) (1)
Adenoma 2 (67%) 4 (80%) 1 (100%)
Carcinoma 1 (100%)
Bilateral, Carcinoma 1 (33%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (60) (60) (60) (60)
Alveolar/Bronchiolar Carcinoma, Metastatic,
Lung 1 (2%)
Histiocytic Sarcoma 1 (2%)
Osteosarcoma, Metastatic, Uncertain Primary
Site 1 (2%)
Urinary Bladder (60) (58) (60) (58)
____________________________________________________________________________________________________________________________________
SYSTEMIC LESIONS
Multiple Organs *(60) *(60) *(60) *(60)
Histiocytic Sarcoma 2 (3%) 1 (2%) 2 (3%)
Lymphoma Malignant Lymphocytic 1 (2%) 3 (5%) 4 (7%) 3 (5%)
Lymphoma Malignant Mixed 7 (12%) 12 (20%) 9 (15%) 7 (12%)
Lymphoma Malignant Undifferentiated Cell 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
* Number of animals with any tissue examined microscopically
Page 5
NTP Experiment-Test: 05108-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 09/14/94
Route: GAVAGE Time: 00:14:27
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE VEHICLE 3.75 7.5 15.0
FEMALE MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
TUMOR SUMMARY
Total Animals with Primary Neoplasms (b) 33 33 30 29
Total Primary Neoplasms 46 46 44 42
Total Animals with Benign Neoplasms 26 20 17 18
Total Benign Neoplasms 31 23 23 23
Total Animals with Malignant Neoplasms 15 21 19 17
Total Malignant Neoplasms 15 23 21 19
Total Animals with Metastatic Neoplasms 5 1 3 1
Total Metastatic Neoplasm 7 2 5 1
Total Animals with Malignant Neoplasms 1
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: 05108-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 09/14/94
Route: GAVAGE Time: 00:14:27
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE VEHICLE 11.25 22.5 45.0
MALE MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially in Study 60 60 60 60
Scheduled Sacrifice 10 10 10 10
Early Deaths
Moribund 8 4 6 6
Dead 3 2 4
Survivors
Terminal Sacrifice 39 44 40 44
Animals Examined Microscopically 60 60 60 60
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Gallbladder (57) (58) (55) (55)
Intestine Large, Colon (59) (59) (59) (60)
Intestine Small, Duodenum (55) (59) (56) (60)
Adenocarcinoma 1 (2%)
Intestine Small, Jejunum (58) (60) (57) (60)
Adenocarcinoma 2 (4%)
Intestine Small, Ileum (59) (59) (59) (60)
Adenocarcinoma 1 (2%)
Liver (60) (60) (59) (60)
Hemangioma 1 (2%)
Hemangiosarcoma 1 (2%)
Hemangiosarcoma, Multiple 2 (3%)
Hepatoblastoma 1 (2%)
Hepatocellular Carcinoma 8 (13%) 9 (15%) 5 (8%) 8 (13%)
Hepatocellular Carcinoma, Multiple 1 (2%)
Hepatocellular Adenoma 14 (23%) 12 (20%) 12 (20%) 11 (18%)
Hepatocellular Adenoma, Multiple 3 (5%) 3 (5%) 3 (5%) 10 (17%)
Hepatocholangiocarcinoma 1 (2%)
Histiocytic Sarcoma 1 (2%) 1 (2%)
Mast Cell Tumor Malignant 1 (2%)
Pancreas (60) (60) (59) (60)
Salivary Glands (58) (60) (60) (60)
Stomach, Forestomach (60) (60) (59) (60)
Squamous Cell Papilloma 1 (2%)
Stomach, Glandular (60) (60) (59) (60)
Hemangiosarcoma, Metastatic, Liver 1 (2%)
Tongue (1) (2) (2)
Squamous Cell Papilloma 1 (50%) 1 (50%)
____________________________________________________________________________________________________________________________________
Page 7
NTP Experiment-Test: 05108-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 09/14/94
Route: GAVAGE Time: 00:14:27
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE VEHICLE 11.25 22.5 45.0
MALE MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (60) (60) (60) (60)
Hemangiosarcoma 1 (2%)
Hepatocholangiocarcinoma, Metastatic, Liver 1 (2%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (58) (60) (58) (58)
Adenoma 1 (2%) 1 (2%) 3 (5%)
Capsule, Adenoma 1 (2%) 1 (2%) 2 (3%)
Adrenal Medulla (56) (56) (56) (55)
Islets, Pancreatic (60) (60) (59) (60)
Adenoma 1 (2%) 3 (5%)
Pituitary Gland (58) (60) (55) (56)
Sarcoma, Metastatic, Nose 1 (2%)
Thyroid Gland (58) (60) (58) (60)
Follicular Cell, Adenoma 1 (2%)
Follicular Cell, Carcinoma 1 (2%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Epididymis (60) (60) (60) (60)
Preputial Gland (17) (24) (20) (21)
Adenoma 1 (4%)
Prostate (55) (55) (57) (55)
Seminal Vesicle (60) (60) (60) (60)
Testes (60) (59) (60) (60)
Interstitial Cell, Adenoma 1 (2%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (59) (60) (60) (60)
Hemangiosarcoma 1 (2%)
Histiocytic Sarcoma 1 (2%)
Mast Cell Tumor Malignant 1 (2%)
Lymph Node (1) (1) (4) (1)
Axillary, Mast Cell Tumor Malignant 1 (25%)
Mediastinal, Mast Cell Tumor Malignant 1 (25%)
Lymph Node, Mandibular (53) (51) (53) (54)
Page 8
NTP Experiment-Test: 05108-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 09/14/94
Route: GAVAGE Time: 00:14:27
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE VEHICLE 11.25 22.5 45.0
MALE MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - cont
Mast Cell Tumor Malignant 1 (2%)
Lymph Node, Mesenteric (53) (55) (53) (56)
Spleen (59) (58) (60) (60)
Hemangioma 1 (2%)
Hemangiosarcoma 1 (2%) 2 (3%)
Histiocytic Sarcoma 1 (2%)
Mast Cell Tumor Malignant 1 (2%)
Thymus (47) (48) (52) (51)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Skin (60) (60) (60) (60)
Squamous Cell Carcinoma 1 (2%)
Subcutaneous Tissue, Hemangioma 1 (2%)
Subcutaneous Tissue, Hemangiosarcoma 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Skeletal Muscle (1) (3) (1) (1)
Hepatocholangiocarcinoma, Metastatic, Liver 1 (33%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (60) (60) (60) (60)
Meningioma Benign 1 (2%)
Sarcoma, Metastatic, Nose 1 (2%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (60) (60) (60) (60)
Alveolar/Bronchiolar Adenoma 8 (13%) 6 (10%) 6 (10%) 7 (12%)
Alveolar/Bronchiolar Adenoma, Multiple 1 (2%)
Alveolar/Bronchiolar Carcinoma 2 (3%) 6 (10%) 1 (2%) 1 (2%)
Carcinoma, Metastatic, Harderian Gland 1 (2%)
Carcinoma, Metastatic, Thyroid Gland 1 (2%)
Hepatocellular Carcinoma, Metastatic, Liver 1 (2%) 3 (5%) 3 (5%) 2 (3%)
Hepatocholangiocarcinoma, Metastatic, Liver 1 (2%)
Histiocytic Sarcoma 1 (2%)
Mediastinum, Hemangioma 1 (2%)
Nose (59) (57) (60) (55)
Sarcoma 1 (2%)
____________________________________________________________________________________________________________________________________
Page 9
NTP Experiment-Test: 05108-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 09/14/94
Route: GAVAGE Time: 00:14:27
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE VEHICLE 11.25 22.5 45.0
MALE MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Harderian Gland (1) (4) (2) (3)
Adenoma 2 (50%) 2 (100%) 2 (67%)
Carcinoma 1 (100%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (60) (60) (60) (60)
Renal Tubule, Adenoma 1 (2%) 1 (2%)
Urinary Bladder (59) (60) (58) (59)
____________________________________________________________________________________________________________________________________
SYSTEMIC LESIONS
Multiple Organs *(60) *(60) *(60) *(60)
Histiocytic Sarcoma 1 (2%) 1 (2%)
Lymphoma Malignant Histiocytic 2 (3%)
Lymphoma Malignant Lymphocytic 2 (3%) 2 (3%) 3 (5%)
Lymphoma Malignant Mixed 3 (5%) 6 (10%) 2 (3%) 1 (2%)
____________________________________________________________________________________________________________________________________
* Number of animals with any tissue examined microscopically
Page 10
NTP Experiment-Test: 05108-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 09/14/94
Route: GAVAGE Time: 00:14:27
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE VEHICLE 11.25 22.5 45.0
MALE MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
TUMOR SUMMARY
Total Animals with Primary Neoplasms (b) 32 40 30 38
Total Primary Neoplasms 48 58 52 59
Total Animals with Benign Neoplasms 26 25 24 30
Total Benign Neoplasms 32 29 30 37
Total Animals with Malignant Neoplasms 15 23 14 19
Total Malignant Neoplasms 16 29 22 22
Total Animals with Metastatic Neoplasms 3 5 4 2
Total Metastatic Neoplasm 4 7 4 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
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