TDMS Study 05108-01 Pathology Tables
INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)
PROMETHAZINE HYDROCHLORIDE
NTP Experiment-Test: 05108-01 Report: PEIRPT05
Study Type: CHRONIC Date: 09/13/94
Route: GAVAGE Time: 21:31:41
Facility: TSI Mason Research
Chemical CAS #: 58-33-3
Lock Date: 10/28/91
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: 05108-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 09/13/94
Route: GAVAGE Time: 21:31:41
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE VEHICLE 8.3 16.6 33.3
FEMALE MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially in Study 60 60 60 60
Scheduled Sacrifice 10 10 10 7
Early Deaths
Moribund 12 12 10 11
Accident 1 2
Dead 5 4 9 16
Survivors
Terminal Sacrifice 29 33 31 24
Moribund 2 1
Dead 1
Animals Examined Microscopically 60 60 60 60
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Intestine Large, Colon (59) (57) (53) (49)
Sarcoma 1 (2%)
Intestine Large, Rectum (58) (57) (54) (46)
Sarcoma Stromal, Metastatic, Uterus 1 (2%)
Intestine Small, Ileum (58) (57) (53) (44)
Liver (60) (59) (60) (59)
Hepatocellular Adenoma 1 (2%) 1 (2%)
Pancreas (60) (59) (60) (56)
Salivary Glands (60) (59) (59) (59)
Stomach, Forestomach (59) (59) (60) (57)
Squamous Cell Papilloma 1 (2%) 1 (2%) 1 (2%)
Stomach, Glandular (60) (58) (54) (51)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (60) (60) (60) (59)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (60) (59) (59) (58)
Adenoma 1 (2%)
Adrenal Medulla (60) (59) (60) (58)
Pheochromocytoma Benign 4 (7%) 1 (2%) 2 (3%) 3 (5%)
Islets, Pancreatic (60) (59) (60) (55)
Adenoma 1 (2%) 1 (2%)
Adenoma, Multiple 1 (2%)
Page 2
NTP Experiment-Test: 05108-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 09/13/94
Route: GAVAGE Time: 21:31:41
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE VEHICLE 8.3 16.6 33.3
FEMALE MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM - cont
Pituitary Gland (59) (58) (58) (58)
Pars Distalis, Adenoma 24 (41%) 25 (43%) 19 (33%) 17 (29%)
Pars Distalis, Adenoma, Multiple 4 (7%) 1 (2%) 4 (7%) 1 (2%)
Thyroid Gland (59) (59) (55) (54)
Bilateral, C-Cell, Adenoma 1 (2%) 1 (2%)
C-Cell, Adenoma 4 (7%) 3 (5%) 10 (18%) 1 (2%)
C-Cell, Carcinoma 1 (2%)
Follicular Cell, Adenoma 2 (3%) 2 (3%) 2 (4%)
Follicular Cell, Carcinoma 1 (2%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Clitoral Gland (56) (55) (58) (57)
Adenoma 3 (5%) 9 (16%) 1 (2%) 2 (4%)
Carcinoma 1 (2%)
Ovary (60) (59) (60) (58)
Arrhenoblastoma Benign 1 (2%)
Granulosa Cell Tumor Benign 1 (2%)
Uterus (59) (60) (60) (57)
Polyp Stromal 12 (20%) 7 (12%) 5 (8%) 1 (2%)
Sarcoma 1 (2%) 1 (2%)
Sarcoma Stromal 1 (2%) 1 (2%)
Vagina (1)
Squamous Cell Papilloma 1 (100%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Blood (5) (5) (3) (5)
Bone Marrow (59) (59) (58) (59)
Lymph Node (12) (5) (5) (5)
Lymph Node, Mandibular (60) (59) (59) (59)
Lymph Node, Mesenteric (60) (59) (60) (58)
Spleen (60) (59) (60) (56)
Hemangioma 1 (2%)
Thymus (55) (58) (57) (55)
____________________________________________________________________________________________________________________________________
Page 3
NTP Experiment-Test: 05108-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 09/13/94
Route: GAVAGE Time: 21:31:41
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE VEHICLE 8.3 16.6 33.3
FEMALE MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (58) (54) (59) (52)
Adenoma 3 (5%) 3 (6%)
Fibroadenoma 11 (19%) 9 (17%) 10 (17%) 6 (12%)
Fibroadenoma, Multiple 3 (5%) 4 (7%)
Skin (60) (58) (60) (58)
Basal Cell Adenoma 1 (2%)
Squamous Cell Papilloma 1 (2%)
Subcutaneous Tissue, Fibroma 1 (2%)
Subcutaneous Tissue, Hemangiopericytoma 1 (2%)
Subcutaneous Tissue, Hemangiosarcoma 1 (2%)
Subcutaneous Tissue, Sarcoma 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Skeletal Muscle (2)
Sarcoma 1 (50%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (60) (60) (60) (59)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (60) (59) (60) (59)
Alveolar/Bronchiolar Adenoma 2 (3%) 1 (2%)
Alveolar/Bronchiolar Carcinoma 1 (2%)
Schwannoma Malignant, Metastatic, Ear 1 (2%)
Squamous Cell Carcinoma, Metastatic,
Uncertain Primary Site 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Ear (3)
Schwannoma Malignant 1 (33%)
Squamous Cell Papilloma 1 (33%)
Zymbal's Gland (1)
Carcinoma 1 (100%)
____________________________________________________________________________________________________________________________________
Page 4
NTP Experiment-Test: 05108-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 09/13/94
Route: GAVAGE Time: 21:31:41
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE VEHICLE 8.3 16.6 33.3
FEMALE MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (60) (60) (59) (57)
Urinary Bladder (59) (57) (56) (53)
____________________________________________________________________________________________________________________________________
SYSTEMIC LESIONS
Multiple Organs *(60) *(60) *(60) *(60)
Leukemia Mononuclear 17 (28%) 18 (30%) 13 (22%) 9 (15%)
____________________________________________________________________________________________________________________________________
* Number of animals with any tissue examined microscopically
Page 5
NTP Experiment-Test: 05108-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 09/13/94
Route: GAVAGE Time: 21:31:41
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE VEHICLE 8.3 16.6 33.3
FEMALE MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
TUMOR SUMMARY
Total Animals with Primary Neoplasms (b) 50 44 41 33
Total Primary Neoplasms 96 92 74 50
Total Animals with Benign Neoplasms 43 37 40 24
Total Benign Neoplasms 76 74 56 35
Total Animals with Malignant Neoplasms 19 18 16 15
Total Malignant Neoplasms 20 18 18 15
Total Animals with Metastatic Neoplasms 1 1 1
Total Metastatic Neoplasm 1 1 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: 05108-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 09/13/94
Route: GAVAGE Time: 21:31:41
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE VEHICLE 8.3 16.6 33.3
MALE MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially in Study 60 60 60 60
Scheduled Sacrifice 10 10 10 9
Early Deaths
Moribund 24 27 27 21
Dead 3 5 12 20
Survivors
Terminal Sacrifice 23 14 9 10
Moribund 1
Dead 3 2
Animals Examined Microscopically 60 60 60 60
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Esophagus (60) (60) (59) (59)
Squamous Cell Carcinoma, Metastatic,
Uncertain Primary Site 1 (2%)
Intestine Large, Cecum (57) (56) (52) (45)
Adenocarcinoma 1 (2%)
Polyp Adenomatous 1 (2%)
Intestine Small, Duodenum (59) (58) (56) (53)
Intestine Small, Ileum (56) (57) (53) (45)
Liver (60) (60) (60) (60)
Hepatocellular Carcinoma 1 (2%)
Hepatocellular Adenoma 4 (7%) 2 (3%) 2 (3%) 1 (2%)
Histiocytic Sarcoma 2 (3%)
Mesentery (2) (7) (3) (3)
Hemangiosarcoma 1 (33%)
Pancreas (59) (60) (59) (60)
Acinus, Adenoma 2 (3%) 2 (3%) 1 (2%)
Salivary Glands (60) (60) (60) (59)
Stomach, Forestomach (59) (60) (60) (60)
Squamous Cell Papilloma 1 (2%)
Stomach, Glandular (59) (60) (57) (54)
Tongue (1) (1) (1)
Squamous Cell Papilloma 1 (100%)
____________________________________________________________________________________________________________________________________
Page 7
NTP Experiment-Test: 05108-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 09/13/94
Route: GAVAGE Time: 21:31:41
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE VEHICLE 8.3 16.6 33.3
MALE MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (60) (60) (60) (60)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (60) (60) (59) (60)
Adrenal Medulla (60) (60) (59) (59)
Pheochromocytoma Malignant 3 (5%) 1 (2%) 1 (2%) 1 (2%)
Pheochromocytoma Complex 1 (2%)
Pheochromocytoma Benign 10 (17%) 6 (10%) 8 (14%) 1 (2%)
Bilateral, Pheochromocytoma Benign 4 (7%) 5 (8%) 1 (2%) 1 (2%)
Islets, Pancreatic (60) (60) (59) (58)
Adenoma 5 (8%) 2 (3%) 2 (3%) 1 (2%)
Parathyroid Gland (56) (57) (57) (56)
Pituitary Gland (60) (60) (58) (59)
Pars Distalis, Adenoma 20 (33%) 17 (28%) 16 (28%) 8 (14%)
Pars Distalis, Adenoma, Multiple 1 (2%) 1 (2%) 1 (2%)
Thyroid Gland (59) (59) (54) (50)
Bilateral, C-Cell, Adenoma 1 (2%)
C-Cell, Adenoma 4 (7%) 4 (7%) 3 (6%) 2 (4%)
Follicular Cell, Adenoma 1 (2%) 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
Tissue NOS (1)
Squamous Cell Carcinoma, Metastatic,
Uncertain Primary Site 1 (100%)
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Epididymis (60) (60) (60) (60)
Preputial Gland (58) (60) (58) (58)
Adenoma 2 (3%) 5 (8%) 2 (3%) 2 (3%)
Bilateral, Adenoma 1 (2%)
Prostate (58) (60) (60) (57)
Seminal Vesicle (59) (60) (59) (60)
Testes (60) (60) (60) (60)
Bilateral, Interstitial Cell, Adenoma 34 (57%) 30 (50%) 33 (55%) 37 (62%)
Interstitial Cell, Adenoma 18 (30%) 18 (30%) 17 (28%) 13 (22%)
____________________________________________________________________________________________________________________________________
Page 8
NTP Experiment-Test: 05108-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 09/13/94
Route: GAVAGE Time: 21:31:41
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE VEHICLE 8.3 16.6 33.3
MALE MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Blood (11) (12) (13) (7)
Bone Marrow (60) (60) (58) (59)
Histiocytic Sarcoma 1 (2%)
Lymph Node (15) (16) (15) (5)
Lymph Node, Mandibular (60) (60) (59) (59)
Lymph Node, Mesenteric (59) (60) (60) (59)
Spleen (60) (60) (59) (60)
Fibroma 1 (2%)
Thymus (51) (53) (56) (55)
Histiocytic Sarcoma 1 (2%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (58) (52) (47) (46)
Adenoma 1 (2%) 1 (2%)
Adenoma, Multiple 1 (2%)
Fibroadenoma 4 (7%) 2 (4%)
Skin (60) (60) (60) (60)
Basosquamous Tumor Benign 1 (2%)
Keratoacanthoma 2 (3%)
Squamous Cell Carcinoma 1 (2%)
Squamous Cell Papilloma 2 (3%) 1 (2%)
Trichoepithelioma 1 (2%)
Subcutaneous Tissue, Fibroma 3 (5%) 3 (5%) 3 (5%) 2 (3%)
Subcutaneous Tissue, Fibroma, Multiple 1 (2%)
Subcutaneous Tissue, Osteosarcoma 1 (2%)
Subcutaneous Tissue, Sarcoma 1 (2%)
Subcutaneous Tissue, Schwannoma Malignant 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Skeletal Muscle (1) (6) (1)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (60) (60) (60) (60)
Astrocytoma Malignant 1 (2%) 1 (2%)
Glioma Malignant 1 (2%)
____________________________________________________________________________________________________________________________________
Page 9
NTP Experiment-Test: 05108-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 09/13/94
Route: GAVAGE Time: 21:31:41
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE VEHICLE 8.3 16.6 33.3
MALE MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (60) (60) (59) (60)
Alveolar/Bronchiolar Adenoma 1 (2%) 1 (2%)
Alveolar/Bronchiolar Carcinoma 1 (2%)
Osteosarcoma, Metastatic, Skin 1 (2%)
Squamous Cell Carcinoma, Multiple 1 (2%)
Nose (60) (60) (60) (60)
Fibroma 1 (2%)
Squamous Cell Papilloma 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Zymbal's Gland (1)
Carcinoma 1 (100%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (60) (60) (60) (60)
Histiocytic Sarcoma 1 (2%)
Lipoma 1 (2%)
Liposarcoma 1 (2%)
Squamous Cell Carcinoma, Metastatic,
Uncertain Primary Site 1 (2%)
Renal Tubule, Adenoma 1 (2%) 1 (2%)
Renal Tubule, Carcinoma 2 (3%)
Urinary Bladder (59) (58) (59) (57)
Transitional Epithelium, Papilloma 1 (2%)
____________________________________________________________________________________________________________________________________
SYSTEMIC LESIONS
Multiple Organs *(60) *(60) *(60) *(60)
Histiocytic Sarcoma 2 (3%) 1 (2%)
Leukemia Mononuclear 22 (37%) 31 (52%) 24 (40%) 19 (32%)
Mesothelioma Malignant 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
* Number of animals with any tissue examined microscopically
Page 10
NTP Experiment-Test: 05108-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 09/13/94
Route: GAVAGE Time: 21:31:41
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE VEHICLE 8.3 16.6 33.3
MALE MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
TUMOR SUMMARY
Total Animals with Primary Neoplasms (b) 57 52 57 54
Total Primary Neoplasms 151 136 131 99
Total Animals with Benign Neoplasms 57 52 54 52
Total Benign Neoplasms 120 103 96 74
Total Animals with Malignant Neoplasms 28 32 29 23
Total Malignant Neoplasms 31 33 35 25
Total Animals with Metastatic Neoplasms 1 1
Total Metastatic Neoplasm 1 3
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 11
------------------------------------------------------------
---------- END OF REPORT ----------
------------------------------------------------------------