NTP Experiment-Test: 05184-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC GLUTARALDEHYDE Date: 07/13/98
Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 14:54:51
CORE STUDY
Facility: Battelle Northwest
Chemical CAS #: 111-30-8
Lock Date: 07/01/97
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: 05184-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC GLUTARALDEHYDE Date: 07/13/98
Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 14:54:51
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE CONTROL 62.5 PPB 125 PPB 250 PPB
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 50 50 50 50
Early Deaths
Moribund Sacrifice 11 10 10 12
Natural Death 5 3 4 6
Accidently Killed 1
Survivors
Terminal Sacrifice 34 37 35 32
Animals Examined Microscopically 50 50 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Gallbladder (45) (41) (43) (41)
Hyperplasia 1 (2%)
Intestine Small, Duodenum (45) (47) (48) (48)
Necrosis 1 (2%) 1 (2%)
Liver (50) (48) (50) (50)
Amyloid Deposition 1 (2%)
Basophilic Focus 2 (4%) 4 (8%) 5 (10%) 2 (4%)
Clear Cell Focus 2 (4%) 1 (2%)
Eosinophilic Focus 6 (12%) 6 (13%) 4 (8%)
Fatty Change 3 (6%)
Hematopoietic Cell Proliferation 1 (2%)
Hyperplasia, Lymphoid 1 (2%)
Necrosis 1 (2%) 1 (2%) 1 (2%) 2 (4%)
Tension Lipidosis 1 (2%) 1 (2%) 1 (2%) 1 (2%)
Vacuolization Cytoplasmic, Focal 1 (2%)
Bile Duct, Hyperplasia 1 (2%)
Centrilobular, Necrosis 1 (2%) 2 (4%) 1 (2%)
Mesentery (12) (6) (5) (6)
Inflammation, Suppurative 1 (8%) 1 (17%)
Thrombosis 1 (8%) 1 (17%) 1 (17%)
Artery, Inflammation, Chronic Active 2 (17%)
Fat, Necrosis 9 (75%) 5 (83%) 3 (60%) 4 (67%)
Pancreas (50) (48) (49) (49)
Atrophy 1 (2%)
Basophilic Focus 1 (2%) 1 (2%)
Hypertrophy 1 (2%)
Inflammation, Suppurative 1 (2%)
Duct, Cyst 1 (2%) 2 (4%)
Stomach, Forestomach (50) (49) (48) (48)
Hyperplasia, Squamous 1 (2%) 1 (2%) 1 (2%)
Infiltration Cellular, Mast Cell 1 (2%)
Inflammation, Acute 1 (2%) 2 (4%)
Stomach, Glandular (50) (48) (48) (48)
a Number of animals examined microscopically at site and number of animals with lesion
NTP Experiment-Test: 05184-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC GLUTARALDEHYDE Date: 07/13/98
Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 14:54:51
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE CONTROL 62.5 PPB 125 PPB 250 PPB
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Infiltration Cellular, Mixed Cell 1 (2%)
Mineralization 1 (2%) 1 (2%) 1 (2%)
Necrosis 1 (2%)
Tooth (1) (1)
Developmental Malformation 1 (100%) 1 (100%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (50) (49) (50) (50)
Artery, Inflammation 1 (2%)
Atrium, Thrombosis 2 (4%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (50) (49) (49) (50)
Atrophy 1 (2%)
Hyperplasia 2 (4%) 2 (4%) 7 (14%) 1 (2%)
Hypertrophy 2 (4%) 2 (4%) 1 (2%) 2 (4%)
Capsule, Inflammation, Chronic Active 1 (2%)
Adrenal Medulla (50) (49) (48) (49)
Hyperplasia 3 (6%) 1 (2%) 5 (10%) 1 (2%)
Islets, Pancreatic (50) (48) (49) (49)
Hyperplasia 1 (2%) 2 (4%) 1 (2%)
Pituitary Gland (49) (49) (49) (50)
Pars Distalis, Hyperplasia 19 (39%) 24 (49%) 23 (47%) 28 (56%)
Pars Intermedia, Hypertrophy 1 (2%)
Thyroid Gland (50) (48) (50) (50)
Follicular Cell, Hyperplasia 26 (52%) 24 (50%) 30 (60%) 37 (74%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Ovary (49) (47) (49) (50)
Angiectasis 1 (2%) 1 (2%)
Cyst 16 (33%) 12 (26%) 18 (37%) 18 (36%)
Inflammation, Suppurative 1 (2%) 1 (2%)
Thrombosis 1 (2%)
Uterus (50) (48) (49) (49)
Angiectasis 2 (4%) 1 (2%) 1 (2%)
Cyst 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
NTP Experiment-Test: 05184-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC GLUTARALDEHYDE Date: 07/13/98
Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 14:54:51
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE CONTROL 62.5 PPB 125 PPB 250 PPB
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM - CONT
Hemorrhage 1 (2%)
Hydrometra 3 (6%) 7 (15%) 3 (6%) 5 (10%)
Infiltration Cellular, Mast Cell 1 (2%)
Infiltration Cellular, Polymorphonuclear 3 (6%) 1 (2%) 1 (2%)
Inflammation, Chronic 1 (2%)
Necrosis 1 (2%)
Thrombosis 1 (2%)
Myometrium, Hyperplasia 1 (2%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (50) (48) (50) (49)
Infiltration Cellular, Mast Cell 1 (2%)
Necrosis 1 (2%)
Lymph Node (7) (4) (3) (1)
Iliac, Infiltration Cellular, Plasma Cell 1 (14%)
Lumbar, Hyperplasia, Lymphoid 1 (25%)
Lumbar, Inflammation, Suppurative 1 (100%)
Renal, Infiltration Cellular, Plasma Cell 1 (14%)
Lymph Node, Bronchial (29) (32) (37) (36)
Hyperplasia, Lymphoid 1 (3%)
Infiltration Cellular, Plasma Cell 2 (7%)
Lymph Node, Mandibular (43) (40) (39) (38)
Hyperplasia, Lymphoid 1 (2%)
Lymph Node, Mesenteric (47) (48) (46) (46)
Ectasia 1 (2%) 1 (2%)
Hemorrhage 1 (2%) 1 (2%)
Hyperplasia, Lymphoid 4 (9%) 1 (2%)
Lymph Node, Mediastinal (31) (23) (34) (37)
Hemorrhage 1 (3%)
Hyperplasia, Lymphoid 1 (3%)
Infiltration Cellular, Plasma Cell 1 (3%)
Inflammation, Suppurative 1 (3%)
Spleen (50) (48) (48) (49)
Amyloid Deposition 1 (2%)
Hematopoietic Cell Proliferation 11 (22%) 8 (17%) 8 (17%) 12 (24%)
Hyperplasia, Lymphoid 4 (8%) 2 (4%) 1 (2%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Skin (50) (50) (50) (50)
Cyst Epithelial Inclusion 1 (2%)
Hyperplasia 1 (2%)
Inflammation, Chronic Active 1 (2%)
Inflammation, Suppurative 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
NTP Experiment-Test: 05184-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC GLUTARALDEHYDE Date: 07/13/98
Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 14:54:51
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE CONTROL 62.5 PPB 125 PPB 250 PPB
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Skeletal Muscle (2) (1)
Hemorrhage 1 (50%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (49) (50) (50)
Degeneration 1 (2%)
Necrosis 1 (2%)
Artery, Inflammation 1 (2%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Larynx (50) (49) (50) (48)
Inflammation 1 (2%)
Epiglottis, Hyperplasia 1 (2%)
Epiglottis, Metaplasia, Squamous 1 (2%) 1 (2%)
Lung (50) (49) (50) (50)
Hemorrhage 1 (2%)
Inflammation, Chronic Active 1 (2%)
Thrombosis 1 (2%) 2 (4%)
Alveolar Epithelium, Hyperplasia 4 (8%) 4 (8%)
Alveolus, Infiltration Cellular, Histiocyte 1 (2%) 1 (2%)
Mediastinum, Inflammation, Suppurative 1 (2%)
Nose (50) (49) (50) (50)
Inflammation 5 (10%) 7 (14%) 13 (26%) 14 (28%)
Inflammation, Suppurative 1 (2%)
Thrombosis 1 (2%)
Olfactory Epithelium, Atrophy 1 (2%) 3 (6%) 3 (6%)
Olfactory Epithelium, Degeneration, Hyaline 11 (22%) 10 (20%) 15 (30%) 10 (20%)
Respiratory Epithelium, Degeneration, Hyaline 16 (32%) 35 (71%) 32 (64%) 30 (60%)
Respiratory Epithelium, Metaplasia, Squamous 7 (14%) 11 (22%) 16 (32%) 21 (42%)
Turbinate, Necrosis 3 (6%) 1 (2%) 4 (8%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
None
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
NTP Experiment-Test: 05184-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC GLUTARALDEHYDE Date: 07/13/98
Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 14:54:51
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE CONTROL 62.5 PPB 125 PPB 250 PPB
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (49) (49) (49)
Amyloid Deposition 1 (2%)
Hydronephrosis 1 (2%)
Infarct 1 (2%) 2 (4%) 3 (6%) 2 (4%)
Metaplasia, Osseous 1 (2%) 2 (4%)
Nephropathy 20 (40%) 14 (29%) 19 (39%) 16 (33%)
Artery, Inflammation, Chronic Active 1 (2%)
Renal Tubule, Necrosis 1 (2%)
Urinary Bladder (48) (48) (48) (47)
Infiltration Cellular, Mast Cell 1 (2%)
Inflammation, Suppurative 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
NTP Experiment-Test: 05184-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC GLUTARALDEHYDE Date: 07/13/98
Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 14:54:51
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE CONTROL 62.5 PPB 125 PPB 250 PPB
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 50 50 50 50
Early Deaths
Moribund Sacrifice 13 15 6 5
Natural Death 6 8 4 7
Survivors
Terminal Sacrifice 31 27 40 38
Animals Examined Microscopically 50 50 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Liver (49) (50) (50) (49)
Atypia Cellular, Diffuse 1 (2%)
Basophilic Focus 5 (10%) 8 (16%) 4 (8%) 6 (12%)
Clear Cell Focus 9 (18%) 6 (12%) 9 (18%) 7 (14%)
Eosinophilic Focus 7 (14%) 6 (12%) 5 (10%) 3 (6%)
Fatty Change 2 (4%)
Inflammation, Granulomatous 1 (2%)
Mixed Cell Focus 2 (4%) 2 (4%)
Necrosis 1 (2%) 1 (2%) 2 (4%)
Tension Lipidosis 1 (2%)
Centrilobular, Necrosis 2 (4%) 1 (2%)
Mesentery (2) (2) (3) (5)
Artery, Mineralization 1 (50%)
Fat, Necrosis 1 (50%) 2 (100%) 2 (67%) 5 (100%)
Pancreas (47) (49) (50) (48)
Atrophy 1 (2%) 1 (2%)
Basophilic Focus 1 (2%)
Metaplasia, Hepatocyte 1 (2%) 1 (2%)
Duct, Cyst 1 (2%)
Stomach, Forestomach (48) (49) (50) (48)
Diverticulum 1 (2%)
Hyperplasia, Squamous 2 (4%) 1 (2%) 1 (2%)
Inflammation, Acute 2 (4%) 1 (2%)
Necrosis 1 (2%)
Stomach, Glandular (46) (47) (50) (48)
Infiltration Cellular, Mixed Cell 2 (4%)
Metaplasia, Hepatocyte 1 (2%)
Necrosis 1 (2%) 1 (2%)
Tooth (13) (17) (10) (19)
Developmental Malformation 12 (92%) 17 (100%) 10 (100%) 19 (100%)
Inflammation, Chronic Active 2 (15%) 1 (5%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
NTP Experiment-Test: 05184-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC GLUTARALDEHYDE Date: 07/13/98
Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 14:54:51
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE CONTROL 62.5 PPB 125 PPB 250 PPB
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Blood Vessel (1)
Aorta, Mineralization 1 (100%)
Heart (49) (50) (50) (49)
Angiectasis 1 (2%)
Inflammation, Chronic Active 1 (2%) 1 (2%)
Artery, Inflammation 1 (2%) 1 (2%) 1 (2%)
Artery, Mineralization 1 (2%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (47) (49) (50) (49)
Hyperplasia 10 (21%) 9 (18%) 18 (36%) 12 (24%)
Hypertrophy 32 (68%) 26 (53%) 31 (62%) 34 (69%)
Necrosis 1 (2%)
Adrenal Medulla (47) (49) (50) (49)
Hyperplasia 2 (4%) 2 (4%) 2 (4%) 2 (4%)
Necrosis 1 (2%)
Islets, Pancreatic (47) (48) (50) (48)
Hyperplasia 3 (6%) 2 (4%) 1 (2%) 6 (13%)
Pituitary Gland (46) (47) (48) (47)
Pars Distalis, Hyperplasia 2 (4%) 1 (2%) 2 (4%) 4 (9%)
Thyroid Gland (48) (49) (49) (49)
Bilateral, Follicular Cell, Hyperplasia 1 (2%)
Follicular Cell, Hyperplasia 14 (29%) 9 (18%) 11 (22%) 18 (37%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Epididymis (48) (50) (50) (49)
Granuloma Sperm 2 (4%) 1 (2%)
Penis (1)
Inflammation, Acute 1 (100%)
Preputial Gland (48) (49) (50) (47)
Cyst 1 (2%)
Inflammation, Chronic Active 2 (4%) 2 (4%) 2 (4%)
Prostate (49) (48) (50) (47)
Hyperplasia 1 (2%)
Inflammation, Chronic Active 1 (2%) 1 (2%) 1 (2%)
Testes (48) (50) (50) (50)
Atrophy 1 (2%) 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
NTP Experiment-Test: 05184-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC GLUTARALDEHYDE Date: 07/13/98
Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 14:54:51
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE CONTROL 62.5 PPB 125 PPB 250 PPB
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Lymph Node, Mandibular (36) (22) (30) (33)
Hyperplasia, Lymphoid 1 (3%)
Lymph Node, Mesenteric (46) (44) (47) (47)
Infiltration Cellular, Plasma Cell 1 (2%) 1 (2%)
Lymph Node, Mediastinal (29) (27) (33) (30)
Hyperplasia, Lymphoid 1 (3%)
Spleen (48) (48) (50) (48)
Hematopoietic Cell Proliferation 12 (25%) 14 (29%) 12 (24%) 7 (15%)
Hyperplasia, Lymphoid 2 (4%)
Thymus (39) (34) (43) (44)
Hyperplasia, Tubular 1 (2%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Skin (48) (50) (50) (48)
Prepuce, Inflammation, Chronic Active 7 (15%) 7 (14%) 4 (8%) 5 (10%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
None
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (49) (50) (50) (50)
Demyelination, Focal 1 (2%)
Meninges, Infiltration Cellular, Mononuclear
Cell 1 (2%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Larynx (47) (49) (50) (50)
Glands, Inflammation 5 (11%) 3 (6%) 3 (6%) 3 (6%)
Lung (48) (50) (50) (50)
Inflammation, Chronic Active 1 (2%)
Alveolar Epithelium, Hyperplasia 3 (6%) 3 (6%) 5 (10%) 2 (4%)
Alveolus, Infiltration Cellular, Histiocyte 1 (2%) 1 (2%)
Artery, Mediastinum, Mineralization 1 (2%)
Nose (48) (50) (50) (50)
Inflammation 6 (13%) 4 (8%) 3 (6%) 5 (10%)
Polyp, Inflammatory 1 (2%)
Nasolacrimal Duct, Inflammation 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
NTP Experiment-Test: 05184-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC GLUTARALDEHYDE Date: 07/13/98
Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 14:54:51
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE CONTROL 62.5 PPB 125 PPB 250 PPB
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM - CONT
Olfactory Epithelium, Atrophy 1 (2%) 1 (2%) 2 (4%)
Olfactory Epithelium, Degeneration, Hyaline 1 (2%) 1 (2%) 5 (10%) 2 (4%)
Olfactory Epithelium, Metaplasia 1 (2%) 1 (2%)
Respiratory Epithelium, Degeneration, Hyaline 5 (10%) 3 (6%) 6 (12%) 10 (20%)
Respiratory Epithelium, Metaplasia, Squamous 2 (4%) 5 (10%) 6 (12%) 9 (18%)
Turbinate, Necrosis 2 (4%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (1)
Cornea, Inflammation, Acute 1 (100%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (48) (49) (50) (49)
Cyst 4 (8%) 2 (4%)
Hydronephrosis 2 (4%) 3 (6%) 2 (4%) 1 (2%)
Inflammation 1 (2%)
Metaplasia, Osseous 1 (2%) 2 (4%)
Mineralization 1 (2%)
Nephropathy 44 (92%) 43 (88%) 46 (92%) 47 (96%)
Thrombosis 1 (2%)
Glomerulus, Inflammation, Suppurative 1 (2%) 1 (2%)
Papilla, Inflammation, Suppurative 2 (4%)
Renal Tubule, Necrosis 1 (2%) 1 (2%)
Urinary Bladder (47) (48) (50) (47)
Infiltration Cellular, Polymorphonuclear 1 (2%)
Inflammation, Chronic Active 3 (6%) 1 (2%) 1 (2%) 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
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