NTP Experiment-Test: 05068-10 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC CODEINE Date: 04/02/96
Route: DOSED FEED Time: 23:43:31
Facility: Microbiological Associates
Chemical CAS #: 76-57-3
Lock Date: 03/03/92
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: 05068-10 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC CODEINE Date: 04/02/96
Route: DOSED FEED Time: 23:43:31
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 PPM 750 PPM 1500 PPM 3000 PPM
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 60 60 60 60
Scheduled Sacrifice 10 9 9 9
Early Deaths
Moribund Sacrifice 7 9 6 4
Natural Death 7 6 2 11
Survivors
Terminal Sacrifice 35 36 43 34
Natural Death 1 1
Missing 1
Animals Examined Microscopically 60 60 60 59
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Gallbladder (53) (50) (56) (50)
Inflammation, Chronic Active 1 (2%) 1 (2%)
Intestine Small, Duodenum (58) (58) (57) (57)
Ulcer 1 (2%)
Intestine Small, Jejunum (60) (57) (59) (59)
Hemorrhage 1 (2%)
Hyperplasia, Lymphoid 1 (2%) 1 (2%) 1 (2%)
Liver (60) (60) (60) (59)
Angiectasis 1 (2%) 1 (2%)
Atrophy 1 (2%)
Basophilic Focus 1 (2%) 1 (2%) 1 (2%)
Clear Cell Focus 1 (2%)
Congestion 1 (2%)
Cyst 1 (2%) 2 (3%)
Eosinophilic Focus 6 (10%) 7 (12%) 9 (15%) 2 (3%)
Fatty Change, Focal 1 (2%)
Hematopoietic Cell Proliferation 3 (5%) 5 (8%) 3 (5%)
Infarct 2 (3%) 1 (2%)
Inflammation, Chronic Active 11 (18%) 10 (17%) 14 (23%) 6 (10%)
Mineralization 1 (2%)
Mitotic Alteration 1 (2%) 1 (2%)
Mixed Cell Focus 3 (5%) 1 (2%)
Necrosis 2 (3%) 2 (3%) 2 (3%) 2 (3%)
Bile Duct, Hyperplasia 1 (2%)
Centrilobular, Inflammation, Chronic 1 (2%)
Centrilobular, Necrosis 1 (2%)
Centrilobular, Pigmentation 1 (2%)
Hepatocyte, Necrosis 1 (2%)
Kupffer Cell, Hypertrophy 1 (2%)
Mesentery (10) (9) (7) (5)
a Number of animals examined microscopically at site and number of animals with lesion
Page 2
NTP Experiment-Test: 05068-10 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC CODEINE Date: 04/02/96
Route: DOSED FEED Time: 23:43:31
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 PPM 750 PPM 1500 PPM 3000 PPM
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Inflammation, Chronic Active 2 (20%) 1 (20%)
Artery, Inflammation, Chronic Active 1 (14%)
Fat, Necrosis 6 (60%) 8 (89%) 6 (86%) 2 (40%)
Pancreas (60) (60) (60) (59)
Inflammation, Chronic 5 (8%) 4 (7%) 4 (7%)
Inflammation, Chronic Active 2 (3%) 1 (2%) 2 (3%)
Acinar Cell, Atrophy 2 (3%) 1 (2%) 1 (2%) 2 (3%)
Acinar Cell, Depletion Secretory 1 (2%)
Duct, Cyst 1 (2%) 1 (2%) 2 (3%)
Salivary Glands (60) (59) (60) (59)
Inflammation, Chronic 34 (57%) 34 (58%) 34 (57%) 27 (46%)
Stomach, Forestomach (60) (60) (60) (59)
Hyperplasia 1 (2%) 1 (2%) 2 (3%) 1 (2%)
Inflammation, Acute 1 (2%)
Inflammation, Chronic Active 2 (3%) 2 (3%) 3 (5%)
Stomach, Glandular (60) (60) (60) (58)
Cyst 1 (2%)
Dilatation 1 (2%)
Dysplasia 1 (2%)
Inflammation, Chronic Active 3 (5%) 10 (17%) 6 (10%)
Necrosis 2 (3%) 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Blood Vessel (60) (60) (59) (58)
Aorta, Inflammation, Chronic Active 1 (2%)
Heart (60) (60) (60) (59)
Fibrosis 2 (3%)
Inflammation, Chronic Active 2 (3%)
Mineralization 1 (2%)
Thrombosis 2 (3%)
Artery, Inflammation, Chronic Active 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (60) (60) (59) (59)
Angiectasis 1 (2%) 1 (2%)
Cyst 1 (2%)
Cytoplasmic Alteration, Focal 1 (2%)
Hematopoietic Cell Proliferation 2 (3%)
Hypertrophy, Focal 1 (2%)
Inflammation, Chronic Active 3 (5%)
Subcapsular, Hyperplasia 57 (95%) 55 (92%) 58 (98%) 54 (92%)
Adrenal Medulla (59) (59) (59) (57)
Hyperplasia 1 (2%) 2 (3%) 2 (4%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 3
NTP Experiment-Test: 05068-10 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC CODEINE Date: 04/02/96
Route: DOSED FEED Time: 23:43:31
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 PPM 750 PPM 1500 PPM 3000 PPM
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM - CONT
Pituitary Gland (58) (56) (58) (55)
Craniopharyngeal Duct, Hyperplasia 1 (2%)
Pars Distalis, Angiectasis 2 (3%) 1 (2%) 2 (4%)
Pars Distalis, Cyst 1 (2%) 2 (4%)
Pars Distalis, Hyperplasia 12 (21%) 12 (21%) 13 (22%) 11 (20%)
Pars Intermedia, Hyperplasia 1 (2%) 1 (2%)
Thyroid Gland (58) (60) (60) (59)
Inflammation, Chronic Active 2 (3%) 6 (10%) 10 (17%) 4 (7%)
Follicle, Cyst 3 (5%) 1 (2%) 5 (8%) 3 (5%)
Follicular Cell, Hyperplasia, Diffuse 1 (2%)
Follicular Cell, Hyperplasia, Focal 14 (24%) 29 (48%) 43 (72%) 45 (76%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Clitoral Gland (51) (51) (53) (52)
Dilatation 42 (82%) 46 (90%) 47 (89%) 47 (90%)
Inflammation, Chronic Active 3 (6%) 4 (8%) 5 (9%) 10 (19%)
Pigmentation 3 (6%) 2 (4%) 2 (4%) 1 (2%)
Ovary (58) (60) (59) (59)
Abscess 1 (2%) 3 (5%)
Cyst 6 (10%) 12 (20%) 14 (24%) 7 (12%)
Hemorrhage 1 (2%)
Infiltration Cellular, Histiocyte 2 (3%)
Inflammation, Chronic Active 2 (3%) 2 (3%)
Periovarian Tissue, Infiltration Cellular,
Lymphocyte 1 (2%) 1 (2%)
Oviduct (3) (1) (1)
Cyst 1 (33%)
Dilatation 1 (100%)
Inflammation, Chronic Active 1 (33%) 1 (100%)
Uterus (60) (60) (59) (59)
Atrophy 1 (2%)
Dilatation 12 (20%) 14 (23%) 10 (17%) 9 (15%)
Hemorrhage 2 (3%)
Hyperplasia, Cystic 46 (77%) 49 (82%) 46 (78%) 46 (78%)
Inflammation, Chronic Active 1 (2%)
Cervix, Inflammation, Chronic Active 1 (2%)
Lymphatic, Ectasia 1 (2%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 4
NTP Experiment-Test: 05068-10 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC CODEINE Date: 04/02/96
Route: DOSED FEED Time: 23:43:31
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 PPM 750 PPM 1500 PPM 3000 PPM
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (60) (60) (60) (59)
Atrophy 1 (2%)
Congestion 1 (2%) 1 (2%)
Myeloid Cell, Hyperplasia 4 (7%) 2 (3%) 1 (2%) 1 (2%)
Lymph Node (4) (2) (2) (9)
Iliac, Hyperplasia, Lymphoid 1 (50%)
Iliac, Inflammation, Chronic Active 1 (25%)
Inguinal, Pigmentation 1 (50%)
Mediastinal, Hyperplasia, Plasma Cell 1 (11%)
Lymph Node, Mandibular (54) (55) (58) (56)
Hemorrhage 2 (4%) 1 (2%)
Hyperplasia, Lymphoid 1 (2%) 4 (7%) 4 (7%)
Lymph Node, Mesenteric (59) (57) (56) (57)
Cyst 2 (4%)
Fibrosis 1 (2%)
Hematopoietic Cell Proliferation 1 (2%) 1 (2%) 2 (4%)
Hemorrhage 4 (7%) 2 (4%) 1 (2%)
Hyperplasia, Lymphoid 1 (2%)
Infiltration Cellular, Histiocyte 1 (2%)
Inflammation, Chronic Active 1 (2%)
Spleen (60) (60) (60) (58)
Atrophy 1 (2%)
Fibrosis 1 (2%) 1 (2%)
Hematopoietic Cell Proliferation 17 (28%) 19 (32%) 18 (30%) 14 (24%)
Hyperplasia, Lymphoid 1 (2%) 4 (7%) 6 (10%) 3 (5%)
Infiltration Cellular, Plasma Cell 1 (2%)
Pigmentation, Hemosiderin 1 (2%) 2 (3%) 1 (2%)
Capsule, Inflammation, Chronic Active 1 (2%) 1 (2%)
Thymus (48) (50) (56) (51)
Atrophy 5 (10%) 9 (18%) 4 (7%) 6 (12%)
Ectopic Parathyroid Gland 1 (2%) 1 (2%)
Ectopic Thyroid 1 (2%)
Hyperplasia, Lymphoid 2 (4%) 7 (14%) 8 (14%) 5 (10%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (55) (60) (59) (59)
Hyperplasia 2 (3%)
Infiltration Cellular, Lymphocyte 1 (2%)
Inflammation, Chronic Active 1 (2%) 1 (2%)
Skin (60) (60) (60) (59)
Developmental Malformation 1 (2%)
Inflammation, Chronic Active 5 (8%) 3 (5%) 7 (12%) 5 (8%)
Ulcer 1 (2%)
Epidermis, Hyperplasia 1 (2%) 1 (2%) 1 (2%) 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 5
NTP Experiment-Test: 05068-10 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC CODEINE Date: 04/02/96
Route: DOSED FEED Time: 23:43:31
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 PPM 750 PPM 1500 PPM 3000 PPM
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM - CONT
Subcutaneous Tissue, Abscess 1 (2%)
Subcutaneous Tissue, Inflammation, Chronic
Active 1 (2%) 1 (2%)
Subcutaneous Tissue, Pigmentation 1 (2%)
Subcutaneous Tissue, Fat, Atrophy 1 (2%) 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (60) (60) (60) (59)
Dysplasia 12 (20%) 6 (10%) 8 (13%) 6 (10%)
Fracture 1 (2%)
Artery, Inflammation, Chronic Active 1 (2%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (60) (60) (60) (59)
Compression 3 (5%) 1 (2%) 3 (5%) 1 (2%)
Degeneration 1 (2%)
Hemorrhage 1 (2%)
Infiltration Cellular, Histiocyte 1 (2%)
Mineralization 27 (45%) 21 (35%) 22 (37%) 12 (20%)
Artery, Inflammation, Chronic Active 1 (2%)
Meninges, Inflammation, Chronic 1 (2%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (60) (60) (60) (59)
Congestion 1 (2%)
Hemorrhage 1 (2%)
Infiltration Cellular, Lymphocyte 38 (63%) 28 (47%) 33 (55%) 24 (41%)
Infiltration Cellular, Histiocyte 1 (2%)
Pigmentation, Hemosiderin 1 (2%)
Alveolar Epithelium, Hyperplasia 1 (2%) 1 (2%) 2 (3%) 1 (2%)
Nose (60) (60) (59) (59)
Olfactory Epithelium, Degeneration, Hyaline 36 (60%) 39 (65%) 35 (59%) 50 (85%)
Respiratory Epithelium, Degeneration, Hyaline 7 (12%) 6 (10%) 8 (14%) 8 (14%)
Respiratory Epithelium, Hyperplasia,
Glandular 2 (3%)
Respiratory Epithelium, Inflammation,
Chronic Active 1 (2%) 1 (2%) 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 6
NTP Experiment-Test: 05068-10 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC CODEINE Date: 04/02/96
Route: DOSED FEED Time: 23:43:31
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 PPM 750 PPM 1500 PPM 3000 PPM
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (1) (2) (3)
Atrophy 1 (50%)
Inflammation, Chronic Active 1 (50%) 2 (67%)
Cornea, Inflammation, Chronic Active 1 (33%)
Harderian Gland (2) (4) (3) (3)
Hyperplasia, Focal 1 (50%)
Inflammation, Chronic Active 2 (67%) 1 (33%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (60) (60) (60) (59)
Amyloid Deposition 1 (2%)
Atrophy 1 (2%)
Cyst 1 (2%)
Glomerulosclerosis 1 (2%)
Hemorrhage 1 (2%)
Hydronephrosis 1 (2%)
Infarct 1 (2%) 2 (3%) 2 (3%)
Inflammation, Chronic 14 (23%) 19 (32%) 15 (25%) 18 (31%)
Metaplasia, Osseous 1 (2%)
Nephropathy 3 (5%) 2 (3%) 1 (2%)
Capsule, Inflammation, Chronic Active 1 (2%)
Glomerulus, Inflammation, Chronic 1 (2%)
Perirenal Tissue, Inflammation, Chronic
Active 1 (2%)
Renal Tubule, Degeneration, Hyaline 1 (2%) 1 (2%)
Renal Tubule, Karyomegaly 1 (2%)
Renal Tubule, Pigmentation 1 (2%)
Renal Tubule, Regeneration 21 (35%) 28 (47%) 31 (52%) 19 (32%)
Ureter (1)
Infiltration Cellular, Lymphocyte 1 (100%)
Urinary Bladder (60) (59) (60) (59)
Dilatation 1 (2%)
Infiltration Cellular, Lymphocyte 38 (63%) 45 (76%) 46 (77%) 42 (71%)
Inflammation, Chronic Active 1 (2%)
Artery, Inflammation, Chronic Active 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 7
NTP Experiment-Test: 05068-10 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC CODEINE Date: 04/02/96
Route: DOSED FEED Time: 23:43:31
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 PPM 750 PPM 1500 PPM 3000 PPM
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 60 60 60 60
Scheduled Sacrifice 10 10 10 10
Early Deaths
Moribund Sacrifice 4 4 2 1
Natural Death 5 7 3 6
Accidently Killed 1
Survivors
Terminal Sacrifice 41 38 45 43
Animals Examined Microscopically 60 60 60 60
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Gallbladder (44) (50) (50) (50)
Degeneration, Hyaline 1 (2%)
Dilatation 1 (2%)
Inflammation, Chronic 1 (2%)
Inflammation, Chronic Active 1 (2%)
Intestine Large, Cecum (60) (60) (60) (58)
Hyperplasia, Lymphoid 2 (3%)
Intestine Small, Jejunum (60) (60) (59) (58)
Hyperplasia, Lymphoid 1 (2%) 1 (2%)
Intestine Small, Ileum (59) (60) (59) (57)
Hyperplasia, Lymphoid 1 (2%)
Hyperplasia, Plasma Cell 1 (2%)
Inflammation, Chronic Active 1 (2%)
Liver (60) (60) (60) (60)
Basophilic Focus 4 (7%) 4 (7%) 2 (3%) 3 (5%)
Clear Cell Focus 7 (12%) 4 (7%) 2 (3%)
Cyst 1 (2%) 1 (2%)
Eosinophilic Focus 9 (15%) 12 (20%) 5 (8%) 4 (7%)
Fatty Change, Focal 4 (7%) 4 (7%)
Hematopoietic Cell Proliferation 2 (3%)
Infarct 3 (5%) 1 (2%) 2 (3%)
Inflammation, Chronic Active 2 (3%) 4 (7%) 3 (5%) 4 (7%)
Mitotic Alteration 1 (2%) 1 (2%)
Mixed Cell Focus 1 (2%) 1 (2%) 3 (5%)
Necrosis 2 (3%) 3 (5%)
Pigmentation 1 (2%) 1 (2%)
Centrilobular, Cytomegaly 3 (5%) 1 (2%)
Centrilobular, Fatty Change 13 (22%) 18 (30%) 6 (10%) 1 (2%)
Mesentery (1) (3) (3) (2)
Hemorrhage 1 (33%)
Artery, Inflammation, Chronic Active 1 (33%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 8
NTP Experiment-Test: 05068-10 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC CODEINE Date: 04/02/96
Route: DOSED FEED Time: 23:43:31
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 PPM 750 PPM 1500 PPM 3000 PPM
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Fat, Necrosis 3 (100%) 2 (67%) 1 (50%)
Pancreas (59) (60) (60) (60)
Inflammation, Chronic 2 (3%) 1 (2%) 1 (2%)
Acinar Cell, Atrophy 2 (3%) 2 (3%) 1 (2%)
Acinar Cell, Vacuolization Cytoplasmic 1 (2%)
Artery, Inflammation, Chronic Active 1 (2%)
Duct, Cyst 1 (2%)
Salivary Glands (60) (60) (60) (60)
Inflammation, Chronic 27 (45%) 27 (45%) 17 (28%) 14 (23%)
Stomach, Forestomach (60) (60) (60) (60)
Hyperplasia 1 (2%) 2 (3%)
Inflammation, Chronic Active 1 (2%)
Necrosis 1 (2%)
Stomach, Glandular (59) (60) (60) (59)
Developmental Malformation 1 (2%)
Dilatation 1 (2%)
Inflammation, Chronic Active 2 (3%) 3 (5%) 1 (2%)
Necrosis 1 (2%) 1 (2%)
Tooth (9) (9) (7) (2)
Developmental Malformation 9 (100%) 9 (100%) 7 (100%) 2 (100%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (60) (60) (60) (60)
Fibrosis 2 (3%) 1 (2%)
Artery, Inflammation, Chronic Active 1 (2%) 2 (3%)
Atrium, Thrombosis 2 (3%)
Ventricle, Thrombosis 1 (2%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (59) (58) (60) (60)
Hypertrophy, Focal 23 (39%) 26 (45%) 22 (37%) 24 (40%)
Extra Adrenal Tissue, Inflammation, Chronic
Active 1 (2%)
Subcapsular, Hyperplasia 38 (64%) 30 (52%) 29 (48%) 31 (52%)
Islets, Pancreatic (60) (60) (60) (60)
Hyperplasia 10 (17%) 13 (22%) 6 (10%) 1 (2%)
Pituitary Gland (56) (59) (58) (55)
Pars Distalis, Cyst 1 (2%) 2 (3%) 2 (3%) 1 (2%)
Pars Distalis, Hyperplasia 4 (7%) 2 (3%)
Thyroid Gland (59) (60) (60) (60)
Inflammation, Chronic Active 1 (2%)
C-Cell, Hyperplasia, Focal 1 (2%)
Follicle, Cyst 1 (2%) 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 9
NTP Experiment-Test: 05068-10 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC CODEINE Date: 04/02/96
Route: DOSED FEED Time: 23:43:31
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 PPM 750 PPM 1500 PPM 3000 PPM
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM - CONT
Follicular Cell, Hyperplasia, Focal 7 (12%) 25 (42%) 29 (48%) 40 (67%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Epididymis (60) (60) (60) (60)
Granuloma Sperm 1 (2%) 1 (2%)
Inflammation, Chronic Active 5 (8%) 4 (7%) 5 (8%)
Spermatocele 1 (2%)
Preputial Gland (58) (60) (60) (60)
Abscess 1 (2%) 1 (2%) 1 (2%)
Dilatation 49 (84%) 43 (72%) 45 (75%) 46 (77%)
Hyperplasia 1 (2%)
Inflammation, Chronic 8 (14%) 6 (10%) 4 (7%) 5 (8%)
Inflammation, Chronic Active 23 (40%) 20 (33%) 23 (38%) 14 (23%)
Prostate (56) (59) (58) (60)
Hyperplasia 1 (2%)
Inflammation, Acute 1 (2%)
Inflammation, Chronic 12 (21%) 14 (24%) 15 (26%) 11 (18%)
Inflammation, Chronic Active 1 (2%) 2 (3%)
Seminal Vesicle (60) (60) (60) (59)
Atrophy 1 (2%)
Dilatation 10 (17%) 7 (12%) 6 (10%) 1 (2%)
Inflammation, Chronic Active 1 (2%)
Testes (60) (60) (60) (60)
Seminiferous Tubule, Degeneration 3 (5%) 1 (2%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (60) (60) (60) (60)
Congestion 1 (2%) 1 (2%)
Myeloid Cell, Hyperplasia 1 (2%) 1 (2%)
Lymph Node (6) (1) (2)
Hemorrhage 1 (50%)
Pancreatic, Hyperplasia, Lymphoid 1 (50%)
Lymph Node, Mandibular (48) (53) (56) (55)
Hyperplasia, Lymphoid 3 (5%)
Pigmentation, Hemosiderin 1 (2%) 2 (4%)
Lymph Node, Mesenteric (59) (59) (58) (58)
Angiectasis 1 (2%)
Granuloma 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 10
NTP Experiment-Test: 05068-10 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC CODEINE Date: 04/02/96
Route: DOSED FEED Time: 23:43:31
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 PPM 750 PPM 1500 PPM 3000 PPM
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - CONT
Hematopoietic Cell Proliferation 5 (8%) 3 (5%) 1 (2%) 1 (2%)
Hemorrhage 13 (22%) 9 (15%) 9 (16%) 10 (17%)
Hyperplasia, Histiocytic 1 (2%)
Hyperplasia, Lymphoid 1 (2%) 2 (3%) 2 (3%)
Spleen (60) (60) (58) (60)
Hematopoietic Cell Proliferation 14 (23%) 13 (22%) 15 (26%) 10 (17%)
Hyperplasia, Lymphoid 2 (3%)
Hyperplasia, Reticulum Cell 1 (2%)
Inflammation, Chronic Active 1 (2%)
Thymus (53) (44) (52) (54)
Atrophy 5 (9%) 2 (5%) 7 (13%) 3 (6%)
Cyst 1 (2%)
Ectopic Parathyroid Gland 3 (6%)
Hyperplasia, Lymphoid 1 (2%) 2 (5%)
Necrosis 1 (2%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Skin (60) (60) (60) (60)
Foreign Body 1 (2%)
Inflammation, Chronic Active 2 (3%) 3 (5%) 4 (7%) 2 (3%)
Ulcer 1 (2%)
Epidermis, Hyperplasia 1 (2%) 2 (3%) 1 (2%) 5 (8%)
Prepuce, Inflammation, Chronic Active 1 (2%)
Subcutaneous Tissue, Abscess 1 (2%)
Subcutaneous Tissue, Edema 1 (2%)
Subcutaneous Tissue, Inflammation, Chronic
Active 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Skeletal Muscle (1)
Inflammation, Chronic 1 (100%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (60) (59) (60) (60)
Compression 1 (2%)
Cyst 1 (2%)
Mineralization 40 (67%) 25 (42%) 15 (25%) 19 (32%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 11
NTP Experiment-Test: 05068-10 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC CODEINE Date: 04/02/96
Route: DOSED FEED Time: 23:43:31
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 PPM 750 PPM 1500 PPM 3000 PPM
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (60) (60) (60) (60)
Congestion 1 (2%) 1 (2%)
Infiltration Cellular, Lymphocyte 13 (22%) 19 (32%) 15 (25%) 10 (17%)
Infiltration Cellular, Histiocyte 2 (3%) 2 (3%)
Inflammation, Chronic Active 1 (2%) 2 (3%) 1 (2%)
Alveolar Epithelium, Hyperplasia 6 (10%) 5 (8%) 6 (10%) 2 (3%)
Artery, Inflammation, Chronic Active 1 (2%)
Bronchiole, Hyperplasia 1 (2%)
Interstitium, Inflammation, Chronic Active 2 (3%) 2 (3%) 1 (2%)
Pleura, Inflammation, Chronic 1 (2%)
Nose (60) (60) (59) (60)
Exudate 1 (2%) 1 (2%)
Foreign Body 1 (2%)
Olfactory Epithelium, Degeneration, Hyaline 25 (42%) 32 (53%) 30 (51%) 29 (48%)
Respiratory Epithelium, Degeneration, Hyaline 1 (2%) 2 (3%) 4 (7%) 1 (2%)
Respiratory Epithelium, Hyperplasia,
Glandular 2 (3%) 1 (2%) 1 (2%)
Respiratory Epithelium, Inflammation,
Chronic Active 2 (3%)
Respiratory Epithelium, Metaplasia 1 (2%)
Respiratory Epithelium, Proliferation
Connective Tissue 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (1) (1) (1)
Cornea, Inflammation, Chronic Active 1 (100%)
Harderian Gland (3) (3) (5) (3)
Inflammation, Chronic Active 1 (20%)
Zymbal's Gland (1)
Hypertrophy 1 (100%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (60) (60) (60) (60)
Cyst 4 (7%) 2 (3%)
Hydronephrosis 1 (2%)
Infarct 1 (2%)
Inflammation, Chronic 11 (18%) 16 (27%) 11 (18%) 14 (23%)
Inflammation, Chronic Active 2 (3%) 1 (2%)
Metaplasia, Osseous 2 (3%) 3 (5%) 1 (2%)
Nephropathy 52 (87%) 47 (78%) 44 (73%) 38 (63%)
Pigmentation 1 (2%)
Artery, Inflammation, Chronic Active 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 12
NTP Experiment-Test: 05068-10 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC CODEINE Date: 04/02/96
Route: DOSED FEED Time: 23:43:31
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 PPM 750 PPM 1500 PPM 3000 PPM
____________________________________________________________________________________________________________________________________
URINARY SYSTEM - CONT
Bilateral, Hydronephrosis 1 (2%)
Capsule, Fibrosis 1 (2%)
Renal Tubule, Degeneration, Hyaline 1 (2%)
Renal Tubule, Hyperplasia 2 (3%)
Renal Tubule, Necrosis 1 (2%)
Renal Tubule, Pigmentation 1 (2%)
Urinary Bladder (60) (60) (60) (59)
Dilatation 2 (3%) 2 (3%) 3 (5%)
Infiltration Cellular, Lymphocyte 16 (27%) 9 (15%) 9 (15%) 6 (10%)
Inflammation, Acute 1 (2%)
Inflammation, Chronic Active 1 (2%) 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 13
------------------------------------------------------------
---------- END OF REPORT ----------
------------------------------------------------------------