TDMS Study 05068-09 Pathology Tables
NTP Experiment-Test: 05068-09 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC CODEINE Date: 04/02/96
Route: DOSED FEED Time: 13:25:35
Facility: Microbiological Associates
Chemical CAS #: 76-57-3
Lock Date: 04/19/94
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: 05068-09 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC CODEINE Date: 04/02/96
Route: DOSED FEED Time: 13:25:35
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 PPM 400 PPM 800 PPM 1600
PPM
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 60 60 60 60
Scheduled Sacrifice 10 10 9 9
Early Deaths
Moribund Sacrifice 15 9 17 14
Natural Death 7 3 5 5
Survivors
Moribund Sacrifice 1 1
Terminal Sacrifice 28 37 28 32
Animals Examined Microscopically 60 60 60 60
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Intestine Large, Colon (60) (60) (60) (60)
Inflammation 1 (2%)
Intussusception 1 (2%)
Intestine Large, Cecum (60) (58) (59) (59)
Inflammation 1 (2%)
Inflammation, Granulomatous 1 (2%)
Liver (60) (60) (60) (60)
Basophilic Focus 47 (78%) 42 (70%) 33 (55%) 32 (53%)
Clear Cell Focus 5 (8%) 4 (7%) 2 (3%)
Congestion 1 (2%) 3 (5%)
Degeneration 1 (2%)
Developmental Malformation 4 (7%) 2 (3%) 1 (2%)
Eosinophilic Focus 5 (8%) 3 (5%) 3 (5%) 1 (2%)
Fatty Change 10 (17%) 4 (7%) 4 (7%) 3 (5%)
Hematopoietic Cell Proliferation 2 (3%) 1 (2%)
Hepatodiaphragmatic Nodule 3 (5%) 5 (8%) 5 (8%) 1 (2%)
Hyperplasia, Focal 1 (2%)
Infiltration Cellular, Lymphocyte 2 (3%) 1 (2%) 2 (3%) 2 (3%)
Inflammation 4 (7%) 4 (7%) 10 (17%) 9 (15%)
Leukocytosis 1 (2%) 1 (2%) 1 (2%)
Mixed Cell Focus 1 (2%)
Necrosis 2 (3%) 4 (7%)
Bile Duct, Hyperplasia, Focal 1 (2%)
Centrilobular, Degeneration 1 (2%)
Mesentery (8) (5) (6) (3)
Infiltration Cellular, Lymphocyte 1 (13%)
Fat, Inflammation 1 (20%)
Fat, Necrosis 7 (88%) 3 (60%) 5 (83%) 3 (100%)
Lymphatic, Cyst 1 (13%)
Oral Mucosa (3) (1)
Gingival, Cyst 1 (33%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 2
NTP Experiment-Test: 05068-09 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC CODEINE Date: 04/02/96
Route: DOSED FEED Time: 13:25:35
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 PPM 400 PPM 800 PPM 1600
PPM
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Pancreas (60) (60) (60) (60)
Accessory Spleen 1 (2%)
Infiltration Cellular, Lymphocyte 1 (2%) 1 (2%) 2 (3%)
Inflammation 2 (3%) 1 (2%) 1 (2%)
Acinar Cell, Atrophy 27 (45%) 14 (23%) 22 (37%) 27 (45%)
Acinar Cell, Hyperplasia 1 (2%)
Artery, Inflammation 1 (2%)
Pharynx (1)
Palate, Hyperplasia 1 (100%)
Salivary Glands (60) (59) (60) (59)
Atrophy, Focal 1 (2%)
Stomach, Forestomach (60) (60) (60) (59)
Hyperplasia 3 (5%) 4 (7%) 3 (5%) 3 (5%)
Inflammation 2 (3%) 1 (2%) 1 (2%)
Ulcer 2 (3%) 4 (7%) 5 (8%)
Stomach, Glandular (60) (60) (60) (60)
Fibrosis, Focal 1 (2%)
Necrosis 3 (5%) 2 (3%)
Ulcer 3 (5%) 1 (2%)
Tongue (1)
Inflammation 1 (100%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (60) (60) (60) (60)
Cardiomyopathy 12 (20%) 8 (13%) 15 (25%) 9 (15%)
Hypertrophy 1 (2%)
Infiltration Cellular, Lymphocyte 1 (2%)
Atrium, Dilatation 1 (2%)
Atrium, Thrombosis 1 (2%)
Coronary Artery, Inflammation 1 (2%)
Valve, Inflammation, Chronic 1 (2%)
Valve, Pigmentation 1 (2%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (60) (60) (60) (60)
Accessory Adrenal Cortical Nodule 1 (2%)
Angiectasis 13 (22%) 6 (10%) 6 (10%) 3 (5%)
Congestion 1 (2%)
Cytologic Alterations 1 (2%) 1 (2%)
Cytoplasmic Alteration 2 (3%)
Degeneration 1 (2%)
Fibrosis 1 (2%)
Hematopoietic Cell Proliferation 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 3
NTP Experiment-Test: 05068-09 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC CODEINE Date: 04/02/96
Route: DOSED FEED Time: 13:25:35
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 PPM 400 PPM 800 PPM 1600
PPM
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM - CONT
Hemorrhage 1 (2%) 1 (2%)
Hyperplasia, Focal 1 (2%) 9 (15%) 8 (13%) 3 (5%)
Hypertrophy 2 (3%) 1 (2%) 1 (2%)
Necrosis 1 (2%) 1 (2%)
Thrombosis 1 (2%)
Vacuolization Cytoplasmic 2 (3%)
Vacuolization Cytoplasmic, Focal 7 (12%) 6 (10%) 4 (7%) 8 (13%)
Capsule, Inflammation 1 (2%)
Adrenal Medulla (60) (60) (59) (60)
Hyperplasia 8 (13%) 5 (8%) 2 (3%) 2 (3%)
Hyperplasia, Focal 1 (2%)
Infiltration Cellular, Lymphocyte 2 (3%)
Islets, Pancreatic (60) (60) (60) (60)
Hyperplasia 1 (2%)
Parathyroid Gland (53) (44) (47) (52)
Hyperplasia 3 (7%)
Pituitary Gland (56) (60) (59) (60)
Developmental Malformation 1 (2%)
Pars Distalis, Angiectasis 13 (23%) 7 (12%) 11 (19%) 7 (12%)
Pars Distalis, Cyst 16 (29%) 17 (28%) 17 (29%) 15 (25%)
Pars Distalis, Hyperplasia 16 (29%) 19 (32%) 16 (27%) 15 (25%)
Pars Distalis, Hyperplasia, Focal 2 (4%) 1 (2%)
Pars Distalis, Pigmentation 1 (2%)
Pars Intermedia, Angiectasis 1 (2%)
Thyroid Gland (60) (60) (60) (60)
C-Cell, Hyperplasia 4 (7%) 11 (18%) 5 (8%) 5 (8%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Clitoral Gland (57) (57) (59) (60)
Ectasia 6 (11%) 9 (16%) 7 (12%) 21 (35%)
Hyperplasia 9 (16%) 8 (14%) 9 (15%) 6 (10%)
Inflammation 1 (2%) 1 (2%) 3 (5%)
Ovary (60) (60) (60) (60)
Cyst 8 (13%) 4 (7%) 5 (8%) 4 (7%)
Inflammation, Granulomatous 1 (2%)
Corpus Luteum, Hypertrophy 1 (2%)
Uterus (60) (60) (60) (60)
Cyst 1 (2%)
Dilatation 4 (7%) 1 (2%) 7 (12%) 5 (8%)
Fibrosis 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 4
NTP Experiment-Test: 05068-09 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC CODEINE Date: 04/02/96
Route: DOSED FEED Time: 13:25:35
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 PPM 400 PPM 800 PPM 1600
PPM
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM - CONT
Hemorrhage 1 (2%) 2 (3%) 1 (2%)
Endometrium, Hyperplasia 2 (3%)
Vagina (2) (1)
Inflammation 1 (50%) 1 (100%)
Prolapse 1 (100%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (60) (60) (60) (60)
Hemorrhage 1 (2%)
Hyperplasia 2 (3%) 5 (8%) 8 (13%) 7 (12%)
Infiltration Cellular, Histiocyte 1 (2%)
Myelofibrosis 1 (2%)
Erythroid Cell, Atrophy 1 (2%)
Erythroid Cell, Hyperplasia 1 (2%)
Myeloid Cell, Hyperplasia 1 (2%)
Lymph Node (12) (10) (9) (11)
Iliac, Hyperplasia, Plasma Cell 1 (8%)
Mediastinal, Cyst 1 (8%)
Mediastinal, Hemorrhage 6 (50%) 2 (20%) 2 (22%) 4 (36%)
Mediastinal, Pigmentation 3 (25%) 2 (20%) 2 (22%) 2 (18%)
Pancreatic, Pigmentation 1 (10%)
Renal, Hemorrhage 2 (22%)
Renal, Pigmentation 1 (11%)
Lymph Node, Mandibular (58) (59) (58) (58)
Congestion 1 (2%)
Edema 1 (2%)
Hemorrhage 2 (3%) 3 (5%) 4 (7%) 3 (5%)
Hyperplasia, Lymphoid 1 (2%)
Hyperplasia, Plasma Cell 2 (3%) 1 (2%) 3 (5%)
Infiltration Cellular, Histiocyte 1 (2%)
Pigmentation 1 (2%)
Lymph Node, Mesenteric (60) (59) (58) (60)
Edema 1 (2%) 2 (3%)
Hemorrhage 1 (2%) 2 (3%)
Infiltration Cellular, Histiocyte 1 (2%) 3 (5%)
Spleen (60) (60) (60) (60)
Congestion 1 (2%) 1 (2%) 1 (2%)
Depletion Lymphoid 1 (2%)
Developmental Malformation 1 (2%)
Hematopoietic Cell Proliferation 5 (8%) 2 (3%) 5 (8%) 6 (10%)
Hyperplasia, Lymphoid 1 (2%) 1 (2%) 1 (2%)
Necrosis 1 (2%) 1 (2%)
Pigmentation 2 (3%) 2 (3%)
Thymus (52) (56) (56) (54)
Amyloid Deposition 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 5
NTP Experiment-Test: 05068-09 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC CODEINE Date: 04/02/96
Route: DOSED FEED Time: 13:25:35
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 PPM 400 PPM 800 PPM 1600
PPM
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - CONT
Atrophy 30 (58%) 34 (61%) 26 (46%) 25 (46%)
Congestion 1 (2%)
Cyst 1 (2%)
Hemorrhage 2 (4%) 1 (2%) 3 (6%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (60) (60) (59) (60)
Dilatation 1 (2%)
Galactocele 1 (2%) 2 (3%) 3 (5%)
Hyperplasia 8 (13%) 7 (12%) 7 (12%) 8 (13%)
Infiltration Cellular, Histiocyte 1 (2%) 3 (5%)
Inflammation 1 (2%)
Lactation 14 (23%) 23 (38%) 24 (41%) 16 (27%)
Skin (60) (60) (59) (60)
Acanthosis 1 (2%)
Subcutaneous Tissue, Cyst Epithelial
Inclusion 1 (2%)
Tail, Fibrosis 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (60) (60) (60) (60)
Cranium, Hyperostosis 2 (3%) 3 (5%) 3 (5%) 3 (5%)
Femur, Hyperostosis 3 (5%) 6 (10%) 3 (5%) 3 (5%)
Maxilla, Hyperostosis 1 (2%)
Turbinate, Hyperostosis 2 (3%) 2 (3%) 4 (7%) 1 (2%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (60) (60) (60) (60)
Compression 8 (13%) 4 (7%) 10 (17%) 4 (7%)
Degeneration, Focal 1 (2%)
Hemorrhage 2 (3%) 2 (3%) 1 (2%)
Hydrocephalus 2 (3%) 1 (2%) 4 (7%) 1 (2%)
Necrosis 1 (2%)
Meninges, Inflammation, Focal 1 (2%)
Meninges, Thrombosis, Focal 1 (2%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 6
NTP Experiment-Test: 05068-09 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC CODEINE Date: 04/02/96
Route: DOSED FEED Time: 13:25:35
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 PPM 400 PPM 800 PPM 1600
PPM
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (60) (60) (60) (60)
Congestion 2 (3%) 1 (2%)
Hemorrhage 2 (3%) 3 (5%)
Infiltration Cellular, Lymphocyte 3 (5%) 1 (2%) 1 (2%)
Infiltration Cellular, Histiocyte 7 (12%) 8 (13%) 9 (15%) 17 (28%)
Inflammation 7 (12%) 12 (20%) 8 (13%) 15 (25%)
Leukocytosis 1 (2%)
Alveolar Epithelium, Hyperplasia 2 (3%) 2 (3%) 2 (3%)
Nose (60) (60) (60) (60)
Cytoplasmic Alteration 1 (2%)
Edema, Focal 2 (3%) 1 (2%)
Foreign Body 1 (2%)
Fungus 1 (2%)
Hemorrhage 1 (2%)
Infiltration Cellular, Focal, Lymphocyte 1 (2%)
Inflammation 4 (7%) 7 (12%) 8 (13%) 5 (8%)
Thrombosis 1 (2%)
Nares, Hyperplasia 1 (2%)
Nasolacrimal Duct, Inflammation 1 (2%) 3 (5%) 3 (5%)
Olfactory Epithelium, Atrophy, Focal 2 (3%) 1 (2%)
Olfactory Epithelium, Cytoplasmic Alteration 46 (77%) 55 (92%) 51 (85%) 57 (95%)
Respiratory Epithelium, Hyperplasia 2 (3%)
Trachea (60) (60) (60) (60)
Infiltration Cellular, Lymphocyte 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (1) (1) (1) (5)
Hemorrhage 1 (100%) 1 (20%)
Phthisis Bulbi 1 (20%)
Cornea, Inflammation 1 (20%)
Lens, Cataract 1 (100%) 1 (100%) 2 (40%)
Lens, Hyperplasia 1 (100%)
Retina, Atrophy 1 (100%)
Retina, Degeneration 1 (100%) 2 (40%)
Harderian Gland (1) (1)
Infiltration Cellular, Lymphocyte 1 (100%)
Inflammation 1 (100%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 7
NTP Experiment-Test: 05068-09 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC CODEINE Date: 04/02/96
Route: DOSED FEED Time: 13:25:35
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 PPM 400 PPM 800 PPM 1600
PPM
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (60) (60) (60) (60)
Cyst 1 (2%)
Infarct 1 (2%) 4 (7%) 1 (2%)
Infiltration Cellular, Lymphocyte 1 (2%) 1 (2%)
Inflammation 1 (2%)
Mineralization 4 (7%) 2 (3%) 1 (2%)
Necrosis 1 (2%) 2 (3%)
Nephropathy, Chronic 46 (77%) 51 (85%) 49 (82%) 45 (75%)
Bilateral, Hydronephrosis 1 (2%)
Transitional Epithelium, Hyperplasia, Focal 1 (2%)
Urinary Bladder (60) (59) (59) (59)
Infiltration Cellular, Lymphocyte 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 8
NTP Experiment-Test: 05068-09 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC CODEINE Date: 04/02/96
Route: DOSED FEED Time: 13:25:35
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 PPM 400 PPM 800 PPM 1600
PPM
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 60 60 60 60
Scheduled Sacrifice 10 10 10 10
Early Deaths
Moribund Sacrifice 14 23 24 23
Natural Death 7 7 5 7
Survivors
Terminal Sacrifice 29 20 21 20
Animals Examined Microscopically 60 60 60 60
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Intestine Large, Colon (60) (60) (60) (60)
Amyloid Deposition 1 (2%)
Inflammation 1 (2%)
Pigmentation 1 (2%)
Ulcer 1 (2%)
Intestine Large, Rectum (59) (58) (60) (60)
Inflammation 1 (2%)
Pigmentation 1 (2%)
Ulcer 1 (2%)
Intestine Small, Jejunum (56) (58) (57) (56)
Diverticulum 1 (2%)
Inflammation, Chronic 1 (2%)
Intestine Small, Ileum (56) (56) (57) (57)
Cyst 1 (2%)
Liver (60) (60) (60) (60)
Abscess 1 (2%)
Angiectasis 3 (5%)
Atrophy 1 (2%)
Basophilic Focus 22 (37%) 19 (32%) 26 (43%) 21 (35%)
Clear Cell Focus 5 (8%) 1 (2%) 2 (3%) 1 (2%)
Congestion 2 (3%) 1 (2%)
Degeneration 3 (5%) 1 (2%) 2 (3%)
Degeneration, Cystic 14 (23%) 5 (8%) 1 (2%)
Developmental Malformation 2 (3%) 1 (2%)
Eosinophilic Focus 7 (12%) 1 (2%) 6 (10%) 4 (7%)
Fatty Change 5 (8%) 1 (2%) 1 (2%)
Fibrosis 3 (5%) 1 (2%)
Hematopoietic Cell Proliferation 1 (2%) 1 (2%)
Hemorrhage 1 (2%) 1 (2%)
Hepatodiaphragmatic Nodule 3 (5%) 4 (7%) 3 (5%) 1 (2%)
Hyperplasia, Focal 1 (2%)
Infiltration Cellular, Lymphocyte 1 (2%) 1 (2%) 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 9
NTP Experiment-Test: 05068-09 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC CODEINE Date: 04/02/96
Route: DOSED FEED Time: 13:25:35
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 PPM 400 PPM 800 PPM 1600
PPM
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Inflammation, Chronic, Focal 1 (2%) 1 (2%) 1 (2%) 2 (3%)
Leukocytosis 1 (2%)
Mixed Cell Focus 4 (7%) 1 (2%)
Necrosis 2 (3%) 3 (5%) 1 (2%) 1 (2%)
Thrombosis 1 (2%) 1 (2%) 4 (7%) 1 (2%)
Vacuolization Cytoplasmic, Focal 1 (2%)
Bile Duct, Cyst 1 (2%)
Bile Duct, Fibrosis 1 (2%)
Bile Duct, Hyperplasia 1 (2%) 5 (8%) 3 (5%) 1 (2%)
Mesentery (13) (24) (24) (21)
Fat, Necrosis 12 (92%) 24 (100%) 22 (92%) 19 (90%)
Pancreas (60) (60) (60) (60)
Accessory Spleen 1 (2%) 2 (3%)
Amyloid Deposition 1 (2%)
Ectopic Liver 1 (2%) 1 (2%)
Edema 1 (2%)
Infiltration Cellular, Lymphocyte 1 (2%) 1 (2%)
Necrosis 1 (2%)
Acinar Cell, Atrophy 30 (50%) 33 (55%) 34 (57%) 27 (45%)
Artery, Inflammation 1 (2%)
Salivary Glands (60) (60) (60) (60)
Amyloid Deposition 1 (2%)
Atrophy 1 (2%)
Infiltration Cellular, Lymphocyte 1 (2%)
Inflammation, Chronic 1 (2%)
Stomach, Forestomach (60) (60) (60) (60)
Edema 1 (2%)
Hyperkeratosis, Focal 1 (2%)
Hyperplasia 3 (5%) 4 (7%) 2 (3%) 4 (7%)
Ulcer 3 (5%) 3 (5%) 2 (3%) 1 (2%)
Stomach, Glandular (59) (60) (60) (60)
Amyloid Deposition 1 (2%)
Hyperkeratosis, Focal 1 (2%)
Necrosis 1 (2%) 3 (5%) 1 (2%) 2 (3%)
Ulcer 4 (7%) 2 (3%) 4 (7%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (60) (60) (60) (60)
Cardiomyopathy 39 (65%) 31 (52%) 31 (52%) 32 (53%)
Mineralization, Focal 1 (2%)
Atrium, Dilatation 1 (2%) 1 (2%) 1 (2%)
Atrium, Thrombosis 2 (3%) 2 (3%) 5 (8%) 4 (7%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 10
NTP Experiment-Test: 05068-09 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC CODEINE Date: 04/02/96
Route: DOSED FEED Time: 13:25:35
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 PPM 400 PPM 800 PPM 1600
PPM
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (60) (60) (60) (60)
Angiectasis 6 (10%) 7 (12%) 11 (18%) 20 (33%)
Cytologic Alterations 1 (2%)
Hemorrhage 1 (2%) 3 (5%) 2 (3%)
Hyperplasia, Focal 3 (5%) 6 (10%) 2 (3%) 6 (10%)
Hypertrophy 1 (2%) 1 (2%) 1 (2%)
Necrosis 1 (2%) 1 (2%)
Vacuolization Cytoplasmic, Focal 4 (7%) 6 (10%)
Adrenal Medulla (59) (60) (59) (60)
Hyperplasia 25 (42%) 12 (20%) 11 (19%) 9 (15%)
Islets, Pancreatic (60) (60) (60) (60)
Hyperplasia 1 (2%) 1 (2%) 2 (3%)
Parathyroid Gland (48) (51) (52) (53)
Hyperplasia 1 (2%) 1 (2%) 1 (2%)
Pituitary Gland (60) (60) (58) (57)
Congestion 1 (2%)
Pars Distalis, Angiectasis 7 (12%) 1 (2%) 3 (5%) 3 (5%)
Pars Distalis, Cyst 2 (3%) 6 (10%) 3 (5%) 2 (4%)
Pars Distalis, Degeneration 1 (2%)
Pars Distalis, Hyperplasia, Focal 9 (15%) 17 (28%) 11 (19%) 8 (14%)
Pars Intermedia, Angiectasis 2 (3%)
Pars Nervosa, Cyst 1 (2%)
Pars Nervosa, Developmental Malformation 1 (2%)
Thyroid Gland (60) (60) (60) (60)
C-Cell, Hyperplasia 4 (7%) 4 (7%) 6 (10%) 5 (8%)
Follicle, Atrophy 1 (2%)
Follicle, Cyst 1 (2%)
Follicle, Dilatation 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
Tissue NOS (1)
Mediastinum, Infiltration Cellular,
Lymphocyte 1 (100%)
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Epididymis (60) (60) (59) (59)
Edema, Focal 1 (2%)
Granuloma Sperm 1 (2%)
Hypoplasia 1 (2%)
Hypospermia 33 (55%) 35 (58%) 39 (66%) 34 (58%)
Penis (1) (1)
Angiectasis 1 (100%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 11
NTP Experiment-Test: 05068-09 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC CODEINE Date: 04/02/96
Route: DOSED FEED Time: 13:25:35
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 PPM 400 PPM 800 PPM 1600
PPM
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM - CONT
Hemorrhage 1 (100%)
Inflammation 1 (100%)
Preputial Gland (59) (60) (58) (59)
Atrophy 2 (3%)
Depletion Cellular 1 (2%)
Ectasia 1 (2%) 10 (17%) 6 (10%) 4 (7%)
Hyperplasia 3 (5%) 2 (3%) 5 (9%) 11 (19%)
Inflammation 11 (19%) 4 (7%) 4 (7%) 9 (15%)
Prostate (59) (59) (60) (60)
Atrophy 3 (5%) 5 (8%) 3 (5%)
Cytoplasmic Alteration 1 (2%)
Dilatation 1 (2%)
Fibrosis, Focal 1 (2%)
Hemorrhage 1 (2%)
Hyperplasia, Focal 4 (7%) 2 (3%) 2 (3%)
Infiltration Cellular, Focal, Lymphocyte 2 (3%)
Inflammation 7 (12%) 12 (20%) 9 (15%) 3 (5%)
Seminal Vesicle (60) (60) (60) (60)
Depletion Cellular 35 (58%) 42 (70%) 40 (67%) 42 (70%)
Dilatation 1 (2%)
Ectasia 2 (3%)
Infiltration Cellular, Lymphocyte 1 (2%) 1 (2%)
Testes (60) (60) (60) (60)
Atrophy 4 (7%) 4 (7%) 1 (2%) 1 (2%)
Congestion, Focal 1 (2%)
Bilateral, Atrophy 3 (5%) 1 (2%)
Interstitial Cell, Hyperplasia, Focal 5 (8%) 5 (8%) 5 (8%) 2 (3%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (60) (60) (60) (60)
Atrophy 1 (2%)
Congestion 1 (2%)
Hemorrhage 1 (2%)
Hyperplasia 6 (10%) 8 (13%) 5 (8%) 1 (2%)
Myelofibrosis 1 (2%)
Necrosis 1 (2%)
Erythroid Cell, Hyperplasia 4 (7%) 2 (3%) 3 (5%)
Myeloid Cell, Atrophy 1 (2%)
Myeloid Cell, Hyperplasia 1 (2%)
Lymph Node (20) (17) (15) (22)
Lumbar, Pigmentation 1 (5%)
Mediastinal, Hemorrhage 2 (10%) 2 (12%) 2 (13%) 2 (9%)
Mediastinal, Pigmentation 1 (5%) 2 (13%) 2 (9%)
Pancreatic, Lymphocyte, Hyperplasia 1 (5%)
Lymph Node, Mandibular (60) (59) (59) (59)
a Number of animals examined microscopically at site and number of animals with lesion
Page 12
NTP Experiment-Test: 05068-09 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC CODEINE Date: 04/02/96
Route: DOSED FEED Time: 13:25:35
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 PPM 400 PPM 800 PPM 1600
PPM
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - CONT
Amyloid Deposition 1 (2%)
Cyst 1 (2%)
Hemorrhage 3 (5%) 1 (2%) 1 (2%)
Hyperplasia, Lymphoid 1 (2%) 2 (3%)
Hyperplasia, Plasma Cell 1 (2%) 1 (2%) 5 (8%) 4 (7%)
Lymphocyte, Hyperplasia 1 (2%)
Lymph Node, Mesenteric (60) (60) (60) (60)
Amyloid Deposition 1 (2%)
Cyst 2 (3%)
Cyst, Multiple 1 (2%)
Erythrophagocytosis 1 (2%) 1 (2%)
Hemorrhage 1 (2%) 1 (2%)
Hyperplasia, Plasma Cell 1 (2%)
Infiltration Cellular, Histiocyte 1 (2%) 1 (2%) 1 (2%)
Pigmentation 1 (2%) 1 (2%)
Lymphocyte, Hyperplasia 1 (2%)
Spleen (60) (60) (60) (60)
Congestion 1 (2%) 2 (3%) 1 (2%)
Developmental Malformation 4 (7%) 1 (2%)
Fibrosis 2 (3%) 3 (5%) 2 (3%) 2 (3%)
Hematopoietic Cell Proliferation 3 (5%) 4 (7%) 2 (3%) 3 (5%)
Infiltration Cellular, Histiocyte 1 (2%)
Necrosis 1 (2%) 2 (3%)
Pigmentation 1 (2%)
Lymphocyte, Hyperplasia 1 (2%)
Thymus (56) (51) (49) (50)
Atrophy 38 (68%) 34 (67%) 29 (59%) 31 (62%)
Depletion Cellular 1 (2%)
Hemorrhage 3 (5%) 2 (4%) 1 (2%)
Infiltration Cellular, Lymphocyte 1 (2%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (57) (59) (60) (56)
Fibrosis 1 (2%)
Galactocele 1 (2%)
Hemorrhage 1 (2%)
Hyperplasia 3 (5%) 1 (2%) 1 (2%) 1 (2%)
Infiltration Cellular, Lymphocyte 1 (2%)
Infiltration Cellular, Histiocyte 1 (2%)
Lactation 7 (12%) 4 (7%) 2 (4%)
Pigmentation 2 (4%) 2 (3%) 1 (2%) 6 (11%)
Skin (60) (60) (60) (59)
Acanthosis 1 (2%)
Hemorrhage 1 (2%)
Inflammation 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 13
NTP Experiment-Test: 05068-09 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC CODEINE Date: 04/02/96
Route: DOSED FEED Time: 13:25:35
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 PPM 400 PPM 800 PPM 1600
PPM
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM - CONT
Ulcer 1 (2%)
Hair Follicle, Atrophy 1 (2%)
Subcutaneous Tissue, Inflammation 1 (2%)
Tail, Acanthosis, Focal 1 (2%)
Tail, Inflammation 1 (2%)
Tail, Necrosis 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (60) (60) (60) (60)
Hyperostosis 1 (2%)
Rib, Developmental Malformation, Focal 1 (2%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (60) (60) (60) (60)
Compression 1 (2%) 1 (2%)
Hemorrhage 1 (2%) 1 (2%)
Necrosis 1 (2%)
Cerebellum, Necrosis, Focal 1 (2%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (60) (59) (60) (60)
Fibrosis, Focal 1 (2%)
Hemorrhage 2 (3%) 2 (3%) 2 (3%) 1 (2%)
Infiltration Cellular, Focal, Histiocyte 6 (10%) 2 (3%) 3 (5%) 6 (10%)
Infiltration Cellular, Lymphocyte 1 (2%)
Inflammation 4 (7%) 5 (8%) 7 (12%) 11 (18%)
Leukocytosis 1 (2%)
Alveolar Epithelium, Hyperplasia, Focal 3 (5%)
Nose (60) (60) (60) (60)
Angiectasis 2 (3%) 1 (2%)
Edema, Focal 1 (2%) 1 (2%)
Foreign Body 3 (5%) 2 (3%) 2 (3%)
Fungus 5 (8%) 5 (8%) 2 (3%) 1 (2%)
Hemorrhage 1 (2%) 1 (2%)
Infiltration Cellular, Focal, Lymphocyte 2 (3%)
Inflammation 14 (23%) 12 (20%) 10 (17%) 5 (8%)
Inflammation, Acute 1 (2%)
Thrombosis 2 (3%) 1 (2%)
Cartilage, Dysplasia 1 (2%)
Glands, Dilatation, Focal 1 (2%)
Goblet Cell, Hyperplasia, Focal 1 (2%) 1 (2%) 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 14
NTP Experiment-Test: 05068-09 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC CODEINE Date: 04/02/96
Route: DOSED FEED Time: 13:25:35
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 PPM 400 PPM 800 PPM 1600
PPM
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM - CONT
Nasolacrimal Duct, Inflammation 1 (2%) 1 (2%) 1 (2%)
Nasopharyngeal Duct, Metaplasia, Squamous 1 (2%)
Olfactory Epithelium, Atrophy, Focal 3 (5%) 2 (3%) 4 (7%) 4 (7%)
Olfactory Epithelium, Cytoplasmic Alteration 20 (33%) 23 (38%) 36 (60%) 57 (95%)
Olfactory Epithelium, Degeneration 1 (2%)
Olfactory Epithelium, Hyperplasia, Focal 1 (2%)
Olfactory Epithelium, Necrosis, Focal 2 (3%)
Olfactory Epithelium, Vacuolization
Cytoplasmic, Focal 1 (2%)
Respiratory Epithelium, Cytoplasmic
Alteration, Focal 1 (2%) 1 (2%)
Respiratory Epithelium, Hyperplasia 1 (2%) 3 (5%)
Trachea (60) (60) (60) (60)
Infiltration Cellular, Focal, Lymphocyte 1 (2%)
Inflammation 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (1) (1) (2) (1)
Phthisis Bulbi 1 (50%)
Lens, Cataract 1 (100%) 1 (100%)
Retina, Degeneration 1 (100%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (60) (60) (60) (60)
Congestion 1 (2%)
Infarct 2 (3%)
Infiltration Cellular, Lymphocyte 1 (2%) 1 (2%)
Nephropathy, Chronic 50 (83%) 46 (77%) 44 (73%) 40 (67%)
Pigmentation 1 (2%) 8 (13%) 4 (7%) 2 (3%)
Bilateral, Hydronephrosis 1 (2%)
Glomerulus, Degeneration 1 (2%)
Transitional Epithelium, Hyperplasia, Focal 1 (2%)
Urethra (1)
Inflammation 1 (100%)
Transitional Epithelium, Hyperplasia 1 (100%)
Urinary Bladder (60) (59) (58) (59)
Amyloid Deposition 1 (2%)
Dilatation 1 (2%) 2 (3%)
Hemorrhage 1 (2%)
Infiltration Cellular, Lymphocyte 1 (2%) 1 (2%)
Inflammation 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 15
NTP Experiment-Test: 05068-09 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC CODEINE Date: 04/02/96
Route: DOSED FEED Time: 13:25:35
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 PPM 400 PPM 800 PPM 1600
PPM
____________________________________________________________________________________________________________________________________
URINARY SYSTEM - CONT
Transitional Epithelium, Hyperplasia 1 (2%) 1 (2%) 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 16
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