TDMS Study 05108-01 Pathology Tables
INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)
PROMETHAZINE HYDROCHLORIDE
NTP Experiment-Test: 05108-01 Report: PEIRPT03
Study Type: CHRONIC Date: 09/13/94
Route: GAVAGE Time: 21:31:40
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 NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 09/13/94
Route: GAVAGE Time: 21:31:40
____________________________________________________________________________________________________________________________________
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
Esophagus (60) (59) (60) (58)
Erosion 1 (2%)
Hyperkeratosis 1 (2%) 1 (2%)
Inflammation, Acute 1 (2%)
Intestine Small, Duodenum (59) (57) (54) (47)
Necrosis 1 (2%)
Intestine Small, Ileum (58) (57) (53) (44)
Necrosis 1 (2%)
Liver (60) (59) (60) (59)
Basophilic Focus 28 (47%) 32 (54%) 23 (38%) 20 (34%)
Clear Cell Focus 2 (3%) 1 (2%)
Fatty Change, Diffuse 2 (3%)
Fatty Change, Focal 5 (8%) 1 (2%)
Fibrosis 2 (3%)
Hemorrhage 1 (2%)
Hepatodiaphragmatic Nodule 1 (2%) 6 (10%) 5 (8%) 10 (17%)
Inflammation, Granulomatous 6 (10%) 1 (2%) 2 (3%) 1 (2%)
Mixed Cell Focus 3 (5%) 1 (2%) 2 (3%) 7 (12%)
Necrosis 1 (2%) 1 (2%)
Pigmentation 2 (3%) 1 (2%)
Bile Duct, Hyperplasia 1 (2%)
Mesentery (1) (3) (1)
Fat, Mineralization 1 (100%)
Fat, Necrosis 1 (100%) 2 (67%)
Pancreas (60) (59) (60) (56)
Acinus, Atrophy 1 (2%) 1 (2%)
Acinus, Hyperplasia 1 (2%)
Salivary Glands (60) (59) (59) (59)
Atrophy 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 2
NTP Experiment-Test: 05108-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 09/13/94
Route: GAVAGE Time: 21:31:40
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE VEHICLE 8.3 16.6 33.3
FEMALE MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Duct, Metaplasia, Squamous 1 (2%) 2 (3%) 2 (3%)
Stomach, Forestomach (59) (59) (60) (57)
Hyperkeratosis 2 (3%) 1 (2%)
Hyperplasia, Basal Cell 3 (5%) 1 (2%) 2 (4%)
Necrosis 2 (3%)
Ulcer 1 (2%)
Stomach, Glandular (60) (58) (54) (51)
Hyperplasia 1 (2%) 1 (2%)
Mineralization 1 (2%)
Necrosis 2 (3%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (60) (60) (60) (59)
Cardiomyopathy 29 (48%) 29 (48%) 28 (47%) 27 (46%)
Inflammation, Chronic Active 1 (2%)
Mineralization 1 (2%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (60) (59) (59) (58)
Accessory Adrenal Cortical Nodule 2 (3%) 1 (2%)
Hemorrhage 1 (2%)
Hyperplasia 1 (2%) 1 (2%) 1 (2%) 2 (3%)
Adrenal Medulla (60) (59) (60) (58)
Hyperplasia 2 (3%) 4 (7%) 3 (5%) 1 (2%)
Islets, Pancreatic (60) (59) (60) (55)
Hyperplasia 2 (3%)
Pituitary Gland (59) (58) (58) (58)
Craniopharyngeal Duct, Cyst 1 (2%)
Pars Distalis, Angiectasis 27 (46%) 24 (41%) 20 (34%) 16 (28%)
Pars Distalis, Cyst 7 (12%) 7 (12%) 3 (5%)
Pars Distalis, Hyperplasia 21 (36%) 20 (34%) 18 (31%) 17 (29%)
Pars Intermedia, Hyperplasia 1 (2%) 1 (2%)
Pars Nervosa, Angiectasis 3 (5%)
Pars Nervosa, Cyst 1 (2%)
Thyroid Gland (59) (59) (55) (54)
C-Cell, Hyperplasia 10 (17%) 6 (10%) 8 (15%) 7 (13%)
Follicle, Cyst 2 (3%) 1 (2%) 1 (2%)
Follicular Cell, Hyperplasia 1 (2%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 3
NTP Experiment-Test: 05108-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 09/13/94
Route: GAVAGE Time: 21:31:40
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE VEHICLE 8.3 16.6 33.3
FEMALE MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Clitoral Gland (56) (55) (58) (57)
Dilatation 1 (2%)
Hyperplasia 1 (2%)
Inflammation, Acute 1 (2%) 1 (2%)
Necrosis 2 (4%)
Ovary (60) (59) (60) (58)
Cyst 3 (5%) 1 (2%) 2 (3%)
Uterus (59) (60) (60) (57)
Cyst 1 (2%)
Decidual Reaction 1 (2%)
Hemorrhage 1 (2%) 1 (2%)
Inflammation, Acute 1 (2%)
Metaplasia, Osseous 1 (2%)
Cervix, Fibrosis 1 (2%)
Cervix, Inflammation, Acute 1 (2%)
Cervix, Pigmentation 1 (2%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Lymph Node (12) (5) (5) (5)
Mediastinal, Angiectasis 1 (20%)
Mediastinal, Pigmentation 1 (20%)
Pancreatic, Angiectasis 1 (8%)
Pancreatic, Hemorrhage 1 (20%)
Pancreatic, Infiltration Cellular, Histiocyte 2 (17%)
Lymph Node, Mandibular (60) (59) (59) (59)
Angiectasis 1 (2%)
Hemorrhage 1 (2%)
Lymph Node, Mesenteric (60) (59) (60) (58)
Angiectasis 1 (2%) 1 (2%)
Hemorrhage 1 (2%)
Hyperplasia 1 (2%)
Infiltration Cellular, Histiocyte 2 (3%)
Spleen (60) (59) (60) (56)
Fibrosis 2 (3%) 2 (3%) 1 (2%)
Hematopoietic Cell Proliferation 3 (5%) 2 (3%) 1 (2%)
Hemorrhage 1 (2%)
Infarct 1 (2%) 1 (2%)
Infiltration Cellular, Histiocyte 2 (3%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 4
NTP Experiment-Test: 05108-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 09/13/94
Route: GAVAGE Time: 21:31:40
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE VEHICLE 8.3 16.6 33.3
FEMALE MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - CONT
Thymus (55) (58) (57) (55)
Fibrosis 1 (2%)
Hemorrhage 1 (2%)
Epithelial Cell, Ectopic Parathyroid Gland 1 (2%)
Epithelial Cell, Hyperplasia 1 (2%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (58) (54) (59) (52)
Galactocele 14 (24%) 5 (9%) 5 (8%) 5 (10%)
Skin (60) (58) (60) (58)
Cyst Epithelial Inclusion 2 (3%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (59) (59) (60) (59)
Fibrous Osteodystrophy 1 (2%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (60) (60) (60) (59)
Degeneration 1 (2%)
Hemorrhage 1 (2%)
Hydrocephalus 1 (2%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (60) (59) (60) (59)
Edema 1 (2%) 2 (3%)
Hemorrhage 1 (2%) 1 (2%)
Infiltration Cellular, Histiocyte 2 (3%) 1 (2%) 1 (2%)
Inflammation, Acute 2 (3%)
Alveolar Epithelium, Hyperplasia 4 (7%) 2 (3%) 1 (2%)
Nose (59) (59) (59) (59)
Fungus 1 (2%) 1 (2%)
Inflammation, Acute 2 (3%) 3 (5%) 6 (10%) 7 (12%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 5
NTP Experiment-Test: 05108-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 09/13/94
Route: GAVAGE Time: 21:31:40
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE VEHICLE 8.3 16.6 33.3
FEMALE MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (1) (1) (3) (3)
Lens, Cataract 1 (100%) 1 (100%) 1 (33%) 1 (33%)
Retina, Atrophy 1 (33%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (60) (60) (59) (57)
Inflammation, Acute 1 (2%)
Mineralization 2 (3%) 1 (2%)
Nephropathy 52 (87%) 52 (87%) 50 (85%) 41 (72%)
Pigmentation 1 (2%)
Artery, Inflammation, Chronic Active 1 (2%)
Bilateral, Papilla, Necrosis 1 (2%)
Cortex, Mineralization 8 (13%) 6 (10%) 8 (14%) 4 (7%)
Pelvis, Inflammation, Chronic Active 1 (2%)
Urinary Bladder (59) (57) (56) (53)
Hemorrhage 1 (2%)
Necrosis 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 6
NTP Experiment-Test: 05108-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 09/13/94
Route: GAVAGE Time: 21:31:40
____________________________________________________________________________________________________________________________________
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)
Hemorrhage 1 (2%) 1 (2%)
Hyperkeratosis 1 (2%) 3 (5%)
Inflammation, Acute 1 (2%) 1 (2%) 1 (2%)
Necrosis 1 (2%)
Intestine Large, Colon (59) (57) (54) (49)
Artery, Inflammation, Chronic Active 2 (4%)
Intestine Large, Cecum (57) (56) (52) (45)
Hyperplasia 1 (2%)
Intestine Small, Ileum (56) (57) (53) (45)
Necrosis 1 (2%)
Liver (60) (60) (60) (60)
Angiectasis 2 (3%) 7 (12%) 2 (3%)
Basophilic Focus 20 (33%) 32 (53%) 25 (42%) 23 (38%)
Clear Cell Focus 8 (13%) 7 (12%) 8 (13%) 13 (22%)
Degeneration, Cystic 5 (8%) 4 (7%) 7 (12%) 4 (7%)
Eosinophilic Focus 2 (3%) 5 (8%) 5 (8%) 4 (7%)
Fatty Change, Diffuse 13 (22%) 15 (25%) 25 (42%) 37 (62%)
Fatty Change, Focal 1 (2%)
Fibrosis 1 (2%)
Hematopoietic Cell Proliferation 1 (2%)
Hepatodiaphragmatic Nodule 11 (18%) 1 (2%) 1 (2%) 1 (2%)
Hyperplasia 1 (2%) 1 (2%)
Infarct 2 (3%)
Leukocytosis 1 (2%)
Mixed Cell Focus 4 (7%) 3 (5%) 8 (13%) 11 (18%)
Necrosis 5 (8%) 1 (2%)
Necrosis, Focal 1 (2%) 1 (2%) 1 (2%)
Thrombosis 2 (3%) 1 (2%)
Artery, Necrosis 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 7
NTP Experiment-Test: 05108-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 09/13/94
Route: GAVAGE Time: 21:31:40
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE VEHICLE 8.3 16.6 33.3
MALE MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Bile Duct, Cyst 1 (2%)
Bile Duct, Hyperplasia 46 (77%) 39 (65%) 22 (37%) 12 (20%)
Centrilobular, Hypertrophy 1 (2%) 8 (13%)
Mesentery (2) (7) (3) (3)
Artery, Inflammation, Chronic Active 1 (14%)
Fat, Fibrosis 1 (33%)
Fat, Hemorrhage 3 (43%) 1 (33%)
Fat, Inflammation, Chronic Active 1 (33%)
Fat, Mineralization 1 (50%) 1 (33%)
Fat, Necrosis 2 (29%) 2 (67%) 1 (33%)
Fat, Pigmentation 1 (14%)
Pancreas (59) (60) (59) (60)
Acinus, Hyperplasia 2 (3%) 1 (2%)
Artery, Fibrosis 1 (2%)
Artery, Inflammation, Chronic Active 1 (2%) 3 (5%)
Pharynx (2)
Inflammation, Acute 1 (50%)
Palate, Inflammation, Acute 1 (50%)
Salivary Glands (60) (60) (60) (59)
Duct, Metaplasia, Squamous 2 (3%) 1 (2%) 2 (3%)
Stomach, Forestomach (59) (60) (60) (60)
Cyst Epithelial Inclusion 1 (2%)
Hyperkeratosis 2 (3%) 5 (8%) 1 (2%) 4 (7%)
Hyperplasia, Basal Cell 5 (8%) 7 (12%) 2 (3%) 6 (10%)
Hyperplasia, Squamous 1 (2%) 1 (2%)
Inflammation, Acute 1 (2%)
Mineralization 1 (2%)
Necrosis 3 (5%) 6 (10%) 2 (3%) 1 (2%)
Ulcer 4 (7%) 1 (2%) 4 (7%)
Stomach, Glandular (59) (60) (57) (54)
Erosion 1 (2%)
Hyperplasia 1 (2%)
Inflammation, Chronic Active 1 (2%)
Mineralization 1 (2%) 10 (17%) 8 (14%)
Necrosis 2 (4%)
Tongue (1) (1) (1)
Hyperkeratosis 1 (100%)
Inflammation, Acute 1 (100%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (60) (60) (60) (60)
Cardiomyopathy 53 (88%) 39 (65%) 46 (77%) 52 (87%)
Congestion 1 (2%)
Inflammation, Acute 1 (2%) 1 (2%)
Mineralization 6 (10%) 5 (8%) 2 (3%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 8
NTP Experiment-Test: 05108-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 09/13/94
Route: GAVAGE Time: 21:31:40
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE VEHICLE 8.3 16.6 33.3
MALE MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM - CONT
Thrombosis 1 (2%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (60) (60) (59) (60)
Accessory Adrenal Cortical Nodule 1 (2%)
Hyperplasia 2 (3%)
Hypertrophy 2 (3%)
Adrenal Medulla (60) (60) (59) (59)
Hyperplasia 13 (22%) 15 (25%) 14 (24%) 9 (15%)
Bilateral, Hyperplasia 2 (3%)
Islets, Pancreatic (60) (60) (59) (58)
Hyperplasia 1 (2%) 2 (3%) 3 (5%)
Parathyroid Gland (56) (57) (57) (56)
Hyperplasia 1 (2%) 8 (14%) 8 (14%) 3 (5%)
Bilateral, Hyperplasia 1 (2%)
Pituitary Gland (60) (60) (58) (59)
Pars Distalis, Angiectasis 12 (20%) 7 (12%) 6 (10%) 3 (5%)
Pars Distalis, Cyst 4 (7%) 3 (5%) 4 (7%)
Pars Distalis, Fibrosis 1 (2%)
Pars Distalis, Hyperplasia 22 (37%) 14 (23%) 16 (28%) 9 (15%)
Pars Distalis, Infarct 1 (2%)
Pars Nervosa, Cyst 1 (2%)
Thyroid Gland (59) (59) (54) (50)
C-Cell, Hyperplasia 9 (15%) 2 (3%) 1 (2%) 1 (2%)
Follicle, Cyst 1 (2%) 1 (2%) 1 (2%)
Follicular Cell, Hyperplasia 3 (5%) 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Preputial Gland (58) (60) (58) (58)
Hyperplasia 2 (3%) 1 (2%) 1 (2%)
Necrosis 1 (2%) 1 (2%) 2 (3%)
Prostate (58) (60) (60) (57)
Hyperplasia 3 (5%)
Inflammation, Chronic Active 2 (3%) 1 (2%) 1 (2%) 2 (4%)
Mineralization 1 (2%)
Seminal Vesicle (59) (60) (59) (60)
Inflammation, Acute 1 (2%) 1 (2%)
Testes (60) (60) (60) (60)
a Number of animals examined microscopically at site and number of animals with lesion
Page 9
NTP Experiment-Test: 05108-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 09/13/94
Route: GAVAGE Time: 21:31:40
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE VEHICLE 8.3 16.6 33.3
MALE MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM - CONT
Atrophy 1 (2%)
Interstitial Cell, Hyperplasia 14 (23%) 20 (33%) 19 (32%) 14 (23%)
Seminiferous Tubule, Atrophy 13 (22%) 5 (8%) 3 (5%) 8 (13%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Lymph Node (15) (16) (15) (5)
Mediastinal, Angiectasis 1 (7%) 1 (7%)
Pancreatic, Pigmentation 1 (7%)
Renal, Angiectasis 1 (6%)
Lymph Node, Mesenteric (59) (60) (60) (59)
Degeneration 1 (2%)
Infiltration Cellular, Histiocyte 1 (2%)
Spleen (60) (60) (59) (60)
Cyst 1 (2%)
Fibrosis 3 (5%) 6 (10%) 4 (7%) 4 (7%)
Hematopoietic Cell Proliferation 2 (3%) 1 (2%) 2 (3%)
Infarct 1 (2%) 1 (2%) 2 (3%)
Thymus (51) (53) (56) (55)
Cyst 1 (2%)
Ectopic Parathyroid Gland 1 (2%)
Epithelial Cell, Hyperplasia 3 (6%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (58) (52) (47) (46)
Galactocele 2 (4%)
Acinus, Hyperplasia 1 (2%)
Skin (60) (60) (60) (60)
Abscess 1 (2%)
Acanthosis 1 (2%)
Cyst Epithelial Inclusion 1 (2%) 1 (2%)
Hyperkeratosis 2 (3%) 1 (2%)
Necrosis 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Skeletal Muscle (1) (6) (1)
Edema 1 (100%)
Hemorrhage 1 (100%)
Necrosis 1 (17%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 10
NTP Experiment-Test: 05108-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 09/13/94
Route: GAVAGE Time: 21:31:40
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE VEHICLE 8.3 16.6 33.3
MALE MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (60) (60) (60) (60)
Hemorrhage 2 (3%)
Mineralization 1 (2%)
Thrombosis 1 (2%)
Peripheral Nerve (1) (2)
Degeneration 1 (100%)
Inflammation, Chronic Active 1 (100%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (60) (60) (59) (60)
Edema 4 (7%) 3 (5%) 5 (8%)
Fibrosis 1 (2%) 1 (2%)
Hemorrhage 3 (5%) 11 (18%) 3 (5%) 1 (2%)
Infiltration Cellular, Histiocyte 2 (3%) 4 (7%) 1 (2%)
Inflammation, Acute 1 (2%) 2 (3%) 2 (3%) 4 (7%)
Alveolar Epithelium, Hyperplasia 3 (5%) 1 (2%)
Artery, Inflammation, Chronic Active 1 (2%)
Bronchiole, Inflammation, Acute 1 (2%)
Mediastinum, Inflammation, Chronic Active 1 (2%) 1 (2%)
Nose (60) (60) (60) (60)
Fungus 7 (12%) 5 (8%) 1 (2%) 5 (8%)
Hyperkeratosis 1 (2%) 1 (2%)
Inflammation, Acute 13 (22%) 11 (18%) 8 (13%) 9 (15%)
Trachea (60) (60) (60) (60)
Erosion 1 (2%)
Inflammation, Acute 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (2) (2) (2) (2)
Atrophy 1 (50%)
Lens, Cataract 1 (50%) 2 (100%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (60) (60) (60) (60)
Cyst 3 (5%) 3 (5%) 2 (3%) 4 (7%)
Developmental Malformation 1 (2%)
Hemorrhage 1 (2%) 1 (2%)
Hydronephrosis 2 (3%)
Mineralization 2 (3%) 6 (10%) 5 (8%) 1 (2%)
Nephropathy 59 (98%) 56 (93%) 58 (97%) 56 (93%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 11
NTP Experiment-Test: 05108-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 09/13/94
Route: GAVAGE Time: 21:31:40
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE VEHICLE 8.3 16.6 33.3
MALE MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
URINARY SYSTEM - CONT
Pelvis, Transitional Epithelium, Hyperplasia 1 (2%)
Pelvis, Transitional Epithelium, Inflammation 1 (2%)
Renal Tubule, Hyperplasia 5 (8%) 1 (2%)
Urinary Bladder (59) (58) (59) (57)
Calculus Gross Observation 1 (2%) 1 (2%)
Calculus Micro Observation Only 1 (2%) 1 (2%)
Dilatation 1 (2%)
Hemorrhage 1 (2%)
Hyperplasia 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 12
------------------------------------------------------------
---------- END OF REPORT ----------
------------------------------------------------------------