TDMS Study 05108-02 Pathology Tables
INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)
PROMETHAZINE HYDROCHLORIDE
NTP Experiment-Test: 05108-02 Report: PEIRPT03
Study Type: CHRONIC Date: 09/14/94
Route: GAVAGE Time: 00:14:25
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 NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 09/14/94
Route: GAVAGE Time: 00:14:25
____________________________________________________________________________________________________________________________________
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
Intestine Large, Colon (60) (59) (60) (60)
Artery, Inflammation, Acute 1 (2%)
Intestine Large, Cecum (59) (59) (59) (58)
Hyperplasia 1 (2%) 1 (2%)
Epithelium, Hyperplasia 3 (5%) 2 (3%)
Intestine Small, Jejunum (56) (59) (58) (57)
Diverticulum 1 (2%)
Erosion 1 (2%)
Inflammation, Chronic Active 1 (2%)
Intestine Small, Ileum (58) (59) (60) (58)
Lymphoid Tissue, Hyperplasia 1 (2%)
Liver (60) (60) (60) (60)
Basophilic Focus 1 (2%) 2 (3%) 2 (3%) 3 (5%)
Clear Cell Focus 1 (2%) 1 (2%)
Eosinophilic Focus 6 (10%) 3 (5%) 5 (8%) 3 (5%)
Fatty Change, Focal 1 (2%)
Hematopoietic Cell Proliferation 1 (2%)
Hematopoietic Cell Proliferation Granulocytic 1 (2%)
Infiltration Cellular, Lymphocyte 2 (3%) 1 (2%)
Inflammation, Focal, Necrotizing 1 (2%)
Inflammation, Granulomatous 1 (2%)
Mixed Cell Focus 4 (7%) 4 (7%) 3 (5%)
Necrosis 2 (3%) 3 (5%) 5 (8%) 1 (2%)
Necrosis, Focal 1 (2%)
Vacuolization Cytoplasmic, Focal 1 (2%) 1 (2%)
Centrilobular, Hypertrophy 1 (2%)
Sinusoid, Centrilobular, Ectasia 1 (2%)
Mesentery (4) (1) (3) (2)
Inflammation, Chronic Active 1 (33%)
Inflammation, Granulomatous 1 (25%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 2
NTP Experiment-Test: 05108-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 09/14/94
Route: GAVAGE Time: 00:14:25
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE VEHICLE 3.75 7.5 15.0
FEMALE MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Fat, Necrosis 2 (50%) 1 (33%) 1 (50%)
Pancreas (60) (59) (60) (59)
Acinus, Atrophy 1 (2%)
Artery, Inflammation, Chronic Active 1 (2%)
Duct, Cyst 1 (2%) 1 (2%)
Duct, Ectasia 1 (2%)
Salivary Glands (59) (60) (60) (59)
Artery, Inflammation, Chronic Active 1 (2%)
Stomach, Forestomach (60) (60) (60) (60)
Acanthosis 2 (3%) 3 (5%) 1 (2%)
Hyperkeratosis 2 (3%) 3 (5%) 3 (5%)
Hyperplasia, Basal Cell 1 (2%) 2 (3%) 1 (2%) 1 (2%)
Hyperplasia, Squamous 1 (2%) 1 (2%)
Inflammation, Chronic Active 1 (2%) 1 (2%)
Stomach, Glandular (59) (59) (60) (59)
Hyperplasia 1 (2%) 2 (3%) 1 (2%)
Inflammation, Chronic Active 2 (3%)
Necrosis 1 (2%)
Ulcer 2 (3%)
Artery, Inflammation, Acute 1 (2%)
Tongue (1)
Congestion 1 (100%)
Hemorrhage 1 (100%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (60) (60) (59) (60)
Mineralization 1 (2%) 1 (2%) 3 (5%)
Artery, Inflammation, Acute 1 (2%)
Artery, Mineralization 1 (2%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (60) (60) (60) (60)
Accessory Adrenal Cortical Nodule 1 (2%) 1 (2%)
Hyperplasia 1 (2%)
Hypertrophy 1 (2%) 2 (3%)
Capsule, Hyperplasia 1 (2%)
Islets, Pancreatic (59) (59) (60) (59)
Hyperplasia 2 (3%) 1 (2%) 1 (2%)
Parathyroid Gland (47) (47) (50) (44)
Infiltration Cellular, Lymphocyte 1 (2%)
Pituitary Gland (56) (59) (59) (58)
Pars Distalis, Angiectasis 3 (5%) 1 (2%) 1 (2%) 6 (10%)
Pars Distalis, Cyst 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 3
NTP Experiment-Test: 05108-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 09/14/94
Route: GAVAGE Time: 00:14:25
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE VEHICLE 3.75 7.5 15.0
FEMALE MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM - CONT
Pars Distalis, Hyperplasia 9 (16%) 14 (24%) 9 (15%) 11 (19%)
Thyroid Gland (60) (60) (57) (60)
Follicle, Cyst 3 (5%) 1 (2%) 1 (2%)
Follicular Cell, Hyperplasia 3 (5%) 5 (8%) 1 (2%) 4 (7%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Clitoral Gland (2) (3)
Dilatation 2 (100%) 3 (100%)
Ovary (59) (59) (58) (58)
Amyloid Deposition 1 (2%)
Angiectasis 2 (3%) 1 (2%) 1 (2%)
Atrophy 1 (2%)
Cyst 10 (17%) 13 (22%) 6 (10%) 12 (21%)
Hemorrhage 1 (2%)
Hyperplasia 1 (2%)
Mineralization 1 (2%)
Pigmentation 1 (2%)
Thrombosis 2 (3%)
Uterus (60) (60) (60) (60)
Angiectasis 1 (2%) 1 (2%)
Hemorrhage 1 (2%)
Hyperplasia 1 (2%)
Inflammation, Acute 1 (2%)
Mineralization 1 (2%)
Pigmentation 1 (2%)
Thrombosis 1 (2%)
Endometrium, Hyperplasia 2 (3%) 3 (5%) 9 (15%) 7 (12%)
Endometrium, Hyperplasia, Cystic 2 (3%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (60) (59) (60) (59)
Angiectasis 1 (2%)
Myelofibrosis 1 (2%)
Lymph Node (4) (7) (3) (2)
Mediastinal, Hematopoietic Cell Proliferation 1 (14%)
Lymph Node, Mandibular (58) (58) (58) (57)
Hematopoietic Cell Proliferation 1 (2%)
Inflammation, Granulomatous 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 4
NTP Experiment-Test: 05108-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 09/14/94
Route: GAVAGE Time: 00:14:25
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE VEHICLE 3.75 7.5 15.0
FEMALE MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - CONT
Lymph Node, Mesenteric (56) (59) (58) (54)
Hemorrhage 1 (2%)
Inflammation, Granulomatous 1 (2%)
Artery, Inflammation, Acute 1 (2%)
Spleen (59) (59) (59) (60)
Amyloid Deposition 1 (2%)
Angiectasis 1 (2%)
Hematopoietic Cell Proliferation 5 (8%) 7 (12%) 5 (8%) 6 (10%)
Infarct 1 (2%)
Thymus (52) (58) (55) (57)
Hyperplasia 1 (2%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Skin (60) (59) (60) (59)
Erosion 1 (2%)
Necrosis 1 (2%) 1 (2%)
Subcutaneous Tissue, Inflammation, Chronic
Active 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (60) (60) (60) (60)
Fracture 1 (2%)
Skeletal Muscle (1) (2)
Inflammation, Chronic Active 1 (50%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (60) (59) (60) (60)
Mineralization 1 (2%)
Spinal Cord (1) (1)
Hemorrhage 1 (100%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (60) (60) (59) (60)
Hemorrhage 1 (2%) 4 (7%) 4 (7%) 1 (2%)
Infiltration Cellular, Histiocyte 1 (2%)
Alveolar Epithelium, Hyperplasia 1 (2%) 3 (5%) 1 (2%) 1 (2%)
Mediastinum, Inflammation, Granulomatous 1 (2%)
Nose (57) (58) (58) (56)
Glands, Cytoplasmic Alteration 2 (3%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 5
NTP Experiment-Test: 05108-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 09/14/94
Route: GAVAGE Time: 00:14:25
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE VEHICLE 3.75 7.5 15.0
FEMALE MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM - CONT
Mucosa, Cytoplasmic Alteration 2 (3%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (1)
Cornea, Inflammation, Acute 1 (100%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (60) (60) (60) (60)
Glomerulosclerosis 1 (2%)
Inflammation, Granulomatous 1 (2%)
Metaplasia, Osseous 1 (2%)
Nephropathy 2 (3%) 4 (7%) 2 (3%)
Artery, Inflammation, Chronic Active 1 (2%)
Papilla, Mineralization 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 6
NTP Experiment-Test: 05108-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 09/14/94
Route: GAVAGE Time: 00:14:25
____________________________________________________________________________________________________________________________________
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
Esophagus (60) (60) (58) (60)
Hyperkeratosis 1 (2%)
Intestine Large, Cecum (59) (60) (59) (60)
Hyperplasia 1 (2%)
Liver (60) (60) (59) (60)
Basophilic Focus 1 (2%) 6 (10%) 2 (3%) 2 (3%)
Clear Cell Focus 1 (2%) 2 (3%) 2 (3%) 1 (2%)
Eosinophilic Focus 3 (5%) 9 (15%) 10 (17%) 12 (20%)
Eosinophilic Focus, Multiple 1 (2%)
Fatty Change 1 (2%)
Fatty Change, Diffuse 1 (2%) 1 (2%) 1 (2%)
Fatty Change, Focal 4 (7%) 2 (3%) 2 (3%) 6 (10%)
Fibrosis 1 (2%)
Hematopoietic Cell Proliferation 1 (2%)
Inflammation, Chronic Active 1 (2%)
Inflammation, Focal, Necrotizing 1 (2%) 1 (2%) 1 (2%)
Inflammation, Granulomatous 1 (2%)
Mixed Cell Focus 3 (5%) 5 (8%) 1 (2%) 7 (12%)
Necrosis 2 (3%)
Necrosis, Focal 2 (3%)
Centrilobular, Hypertrophy 6 (10%) 6 (10%)
Mesentery (1) (2)
Inflammation, Chronic Active 1 (50%)
Fat, Necrosis 1 (100%)
Pancreas (60) (60) (59) (60)
Duct, Cyst 1 (2%)
Stomach, Forestomach (60) (60) (59) (60)
Acanthosis 1 (2%)
Hyperkeratosis 2 (3%) 1 (2%) 1 (2%)
Hyperplasia, Basal Cell 3 (5%) 1 (2%)
Inflammation, Chronic Active 2 (3%) 1 (2%)
Necrosis 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 7
NTP Experiment-Test: 05108-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 09/14/94
Route: GAVAGE Time: 00:14:25
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE VEHICLE 11.25 22.5 45.0
MALE MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Stomach, Glandular (60) (60) (59) (60)
Hyperplasia 1 (2%) 1 (2%)
Inflammation, Chronic Active 1 (2%)
Mineralization 1 (2%)
Necrosis 1 (2%)
Tongue (1) (2) (2)
Mineralization 1 (100%) 1 (50%)
Tooth (1)
Developmental Malformation 1 (100%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (60) (60) (60) (60)
Cardiomyopathy 1 (2%) 2 (3%) 1 (2%)
Mineralization 1 (2%)
Artery, Inflammation, Chronic Active 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (58) (60) (58) (58)
Accessory Adrenal Cortical Nodule 2 (3%) 1 (2%)
Hyperplasia 3 (5%)
Hypertrophy 3 (5%) 6 (10%) 8 (14%) 2 (3%)
Islets, Pancreatic (60) (60) (59) (60)
Hyperplasia 4 (7%) 1 (2%) 3 (5%)
Pituitary Gland (58) (60) (55) (56)
Pars Distalis, Cyst 1 (2%) 1 (2%)
Pars Distalis, Hyperplasia 1 (2%) 1 (2%) 2 (4%)
Thyroid Gland (58) (60) (58) (60)
Artery, Inflammation, Chronic Active 1 (2%)
Follicular Cell, Hyperplasia 3 (5%) 3 (5%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Epididymis (60) (60) (60) (60)
Granuloma Sperm 1 (2%)
Mineralization 1 (2%)
Preputial Gland (17) (24) (20) (21)
Abscess 2 (8%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 8
NTP Experiment-Test: 05108-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 09/14/94
Route: GAVAGE Time: 00:14:25
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE VEHICLE 11.25 22.5 45.0
MALE MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM - CONT
Dilatation 8 (47%) 19 (79%) 16 (80%) 18 (86%)
Prostate (55) (55) (57) (55)
Hyperplasia 1 (2%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Lymph Node (1) (1) (4) (1)
Mediastinal, Angiectasis 1 (25%)
Lymph Node, Mandibular (53) (51) (53) (54)
Hematopoietic Cell Proliferation 1 (2%)
Lymph Node, Mesenteric (53) (55) (53) (56)
Hyperplasia, Lymphoid 1 (2%)
Infiltration Cellular, Histiocyte 1 (2%)
Thrombosis 1 (2%)
Artery, Inflammation, Chronic Active 1 (2%)
Spleen (59) (58) (60) (60)
Angiectasis 4 (7%) 1 (2%)
Hematopoietic Cell Proliferation 2 (3%) 9 (16%) 6 (10%) 3 (5%)
Hyperplasia 4 (7%)
Necrosis 1 (2%)
Thymus (47) (48) (52) (51)
Depletion Lymphoid 1 (2%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Skin (60) (60) (60) (60)
Necrosis 2 (3%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Skeletal Muscle (1) (3) (1) (1)
Artery, Inflammation, Chronic Active 1 (100%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (60) (60) (60) (60)
Inflammation, Chronic Active 1 (2%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 9
NTP Experiment-Test: 05108-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 09/14/94
Route: GAVAGE Time: 00:14:25
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE VEHICLE 11.25 22.5 45.0
MALE MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (60) (60) (60) (60)
Edema 1 (2%)
Hemorrhage 1 (2%) 3 (5%) 3 (5%) 1 (2%)
Infiltration Cellular, Histiocyte 6 (10%) 3 (5%) 1 (2%)
Alveolar Epithelium, Hyperplasia 1 (2%) 2 (3%) 2 (3%) 1 (2%)
Nose (59) (57) (60) (55)
Inflammation, Acute 1 (2%) 2 (3%) 2 (4%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (2) (3)
Cornea, Inflammation, Acute 1 (33%)
Lens, Cataract 1 (50%)
Harderian Gland (1) (4) (2) (3)
Hyperplasia 1 (33%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (60) (60) (60) (60)
Cyst 1 (2%) 4 (7%) 2 (3%)
Infarct 1 (2%)
Infiltration Cellular, Plasma Cell 1 (2%)
Nephropathy 7 (12%) 8 (13%) 9 (15%) 6 (10%)
Artery, Inflammation, Chronic Active 1 (2%)
Cortex, Mineralization 2 (3%)
Papilla, Mineralization 1 (2%)
Renal Tubule, Regeneration 6 (10%) 2 (3%) 6 (10%) 3 (5%)
Urinary Bladder (59) (60) (58) (59)
Calculus Gross Observation 1 (2%)
Calculus Micro Observation Only 2 (3%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 10
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