TDMS Study 05214-02 Pathology Tables
INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)
TRANS-DELTA-9-TETRAHYDROCANNABINOL
NTP Experiment-Test: 05214-02 Report: PEIRPT03
Study Type: CHRONIC Date: 05/20/95
Route: GAVAGE Time: 12:55:03
Facility: TSI Mason Research
Chemical CAS #: 1972-08-3
Lock Date: 06/01/92
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: 05214-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC TRANS-DELTA-9-TETRAHYDROCANNABINOL Date: 05/20/95
Route: GAVAGE Time: 12:55:03
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 125 250 500
MG/KG MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 60 60 60 60
Early Deaths
Natural Death 10 5 13 14
Moribund Sacrifice 3 5 3 3
Accidently Killed 1
Dosing Accident 1
Survivors
Terminal Sacrifice 47 50 44 41
Animals Examined Microscopically 60 60 60 60
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Esophagus (60) (60) (60) (59)
Perforation 1 (2%)
Periesophageal Tissue, Inflammation, Subacute 1 (2%)
Gallbladder (53) (59) (54) (54)
Infiltration Cellular, Lymphocyte 1 (2%)
Epithelium, Ulcer, Chronic Active 1 (2%)
Intestine Large, Colon (57) (60) (58) (57)
Serosa, Inflammation, Chronic 1 (2%)
Intestine Large, Cecum (57) (60) (58) (57)
Atrophy 1 (2%)
Intestine Small, Duodenum (57) (60) (57) (54)
Dysplasia 1 (2%)
Intestine Small, Jejunum (57) (60) (57) (55)
Serosa, Inflammation, Chronic 1 (2%)
Liver (60) (60) (59) (60)
Angiectasis 1 (2%)
Atrophy 1 (2%)
Basophilic Focus 2 (3%) 1 (2%) 1 (2%)
Clear Cell Focus 1 (2%) 3 (5%)
Congestion 1 (2%)
Eosinophilic Focus 9 (15%) 1 (2%) 1 (2%)
Fatty Change 13 (22%) 3 (5%) 2 (3%)
Hematopoietic Cell Proliferation 6 (10%) 2 (3%) 2 (3%) 3 (5%)
Infarct 1 (2%)
Infiltration Cellular, Lymphocyte 1 (2%) 2 (3%)
Inflammation, Acute 1 (2%) 1 (2%)
Inflammation, Chronic 1 (2%)
Mixed Cell Focus 2 (3%) 1 (2%) 2 (3%)
Necrosis 2 (3%) 1 (2%)
Bile Duct, Hyperplasia 1 (2%)
Central Vein, Dilatation 1 (2%)
Centrilobular, Fibrosis 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 2
NTP Experiment-Test: 05214-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC TRANS-DELTA-9-TETRAHYDROCANNABINOL Date: 05/20/95
Route: GAVAGE Time: 12:55:03
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 125 250 500
MG/KG MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Mesentery (11) (1) (1) (3)
Inflammation, Chronic 2 (67%)
Inflammation, Chronic Active 1 (100%)
Fat, Necrosis 9 (82%) 1 (100%)
Pancreas (59) (60) (59) (57)
Atrophy 1 (2%)
Fibrosis 1 (2%)
Infiltration Cellular, Lymphocyte 1 (2%)
Inflammation 1 (2%)
Inflammation, Chronic 4 (7%) 5 (8%) 3 (5%) 3 (5%)
Arteriole, Infiltration Cellular, Lymphocyte 2 (3%)
Arteriole, Inflammation, Chronic 1 (2%)
Duct, Ectasia 1 (2%) 2 (3%) 3 (5%)
Salivary Glands (60) (60) (60) (60)
Atrophy 2 (3%) 1 (2%)
Infiltration Cellular, Lymphocyte 1 (2%)
Stomach, Forestomach (58) (60) (58) (57)
Hyperkeratosis 1 (2%)
Hyperplasia, Squamous 15 (26%) 11 (18%) 10 (17%) 9 (16%)
Inflammation, Chronic 1 (2%) 1 (2%)
Ulcer 2 (3%) 4 (7%) 6 (10%) 4 (7%)
Stomach, Glandular (58) (60) (58) (57)
Dysplasia 1 (2%)
Erosion 3 (5%) 1 (2%)
Hyperplasia 3 (5%) 1 (2%)
Mineralization 1 (2%) 2 (3%)
Ulcer 1 (2%)
Glands, Dilatation 1 (2%)
Tooth (3) (1) (3)
Abscess 1 (33%) 1 (33%)
Dysplasia 2 (67%) 1 (100%) 2 (67%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (60) (60) (60) (60)
Cardiomyopathy 6 (10%) 4 (7%) 5 (8%) 1 (2%)
Degeneration 1 (2%)
Inflammation, Chronic 1 (2%) 1 (2%) 1 (2%)
Atrium, Thrombosis 1 (2%)
Epicardium, Inflammation, Acute 1 (2%)
Valve, Bacterium 3 (5%)
Valve, Degeneration 1 (2%)
Valve, Inflammation, Chronic 3 (5%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 3
NTP Experiment-Test: 05214-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC TRANS-DELTA-9-TETRAHYDROCANNABINOL Date: 05/20/95
Route: GAVAGE Time: 12:55:03
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 125 250 500
MG/KG MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (59) (60) (60) (60)
Hyperplasia 1 (2%) 2 (3%) 2 (3%) 1 (2%)
Capsule, Accessory Adrenal Cortical Nodule 3 (5%) 2 (3%)
Capsule, Hyperplasia 57 (97%) 60 (100%) 59 (98%) 57 (95%)
Capsule, Inflammation, Chronic 1 (2%) 1 (2%)
Zona Reticularis, Hemorrhage 1 (2%)
Zona Reticularis, Necrosis 1 (2%)
Adrenal Medulla (59) (60) (60) (60)
Hyperplasia 1 (2%)
Inflammation, Chronic 1 (2%)
Pigmentation 1 (2%)
Islets, Pancreatic (59) (60) (59) (56)
Hyperplasia 29 (49%) 33 (55%) 19 (32%) 9 (16%)
Parathyroid Gland (49) (54) (49) (51)
Cyst 1 (2%) 1 (2%) 4 (8%)
Pituitary Gland (55) (58) (58) (57)
Pars Distalis, Cyst 3 (5%) 2 (3%) 1 (2%)
Pars Distalis, Hyperplasia 25 (45%) 19 (33%) 10 (17%) 8 (14%)
Thyroid Gland (60) (60) (60) (60)
Infiltration Cellular, Lymphocyte 3 (5%) 2 (3%)
Infiltration Cellular, Polymorphonuclear 1 (2%)
Inflammation, Chronic 1 (2%)
Follicular Cell, Hyperplasia 28 (47%) 46 (77%) 40 (67%) 33 (55%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Clitoral Gland (57) (59) (56) (54)
Abscess 1 (2%) 1 (2%)
Atrophy 1 (2%)
Dilatation 3 (5%)
Hyperplasia, Squamous 1 (2%) 1 (2%)
Inflammation, Chronic 2 (4%) 1 (2%) 1 (2%) 3 (6%)
Ovary (59) (59) (60) (59)
Abscess 2 (3%) 2 (3%) 1 (2%)
Angiectasis 2 (3%) 1 (2%)
Cyst 3 (5%) 1 (2%) 2 (3%) 6 (10%)
Hemorrhage 2 (3%) 1 (2%)
Hyperplasia 1 (2%)
Infiltration Cellular, Lymphocyte 1 (2%) 1 (2%)
Inflammation, Acute 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 4
NTP Experiment-Test: 05214-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC TRANS-DELTA-9-TETRAHYDROCANNABINOL Date: 05/20/95
Route: GAVAGE Time: 12:55:03
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 125 250 500
MG/KG MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM - CONT
Inflammation, Chronic 1 (2%) 2 (3%) 1 (2%)
Pigmentation 1 (2%)
Periovarian Tissue, Cyst 3 (5%) 1 (2%) 1 (2%) 2 (3%)
Periovarian Tissue, Inflammation, Chronic 1 (2%)
Periovarian Tissue, Necrosis 1 (2%)
Uterus (60) (60) (60) (60)
Dilatation 10 (17%) 4 (7%) 5 (8%) 7 (12%)
Inflammation, Acute 2 (3%)
Inflammation, Chronic 1 (2%)
Endometrium, Atrophy 1 (2%)
Endometrium, Hyperplasia, Cystic 52 (87%) 53 (88%) 52 (87%) 39 (65%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (59) (60) (60) (60)
Angiectasis 1 (2%)
Myelofibrosis 35 (59%) 40 (67%) 31 (52%) 23 (38%)
Proliferation 2 (3%) 1 (2%)
Lymph Node (6) (3) (1) (2)
Bronchial, Amyloid Deposition 1 (50%)
Lumbar, Cyst 1 (17%)
Pancreatic, Hyperplasia, Lymphoid 1 (33%)
Lymph Node, Mandibular (56) (59) (59) (57)
Congestion 1 (2%)
Hemorrhage 1 (2%)
Hyperplasia, Lymphoid 6 (11%) 2 (3%) 2 (4%)
Inflammation, Chronic 1 (2%)
Pigmentation, Hemosiderin 1 (2%)
Lymph Node, Mesenteric (57) (60) (57) (53)
Angiectasis 1 (2%) 2 (3%) 1 (2%) 2 (4%)
Atrophy 1 (2%)
Fibrosis 1 (2%)
Hyperplasia, Lymphoid 3 (5%) 1 (2%)
Inflammation, Chronic 1 (2%)
Spleen (59) (60) (60) (59)
Angiectasis 1 (2%)
Lymphoid Follicle, Atrophy 9 (15%) 1 (2%) 2 (3%) 4 (7%)
Lymphoid Follicle, Hyperplasia, Lymphoid 30 (51%) 18 (30%) 17 (28%) 19 (32%)
Red Pulp, Hematopoietic Cell Proliferation 53 (90%) 37 (62%) 28 (47%) 23 (39%)
Thymus (59) (58) (56) (58)
Abscess 1 (2%)
Cyst 6 (10%) 9 (16%) 6 (11%) 8 (14%)
Hyperplasia, Lymphoid 1 (2%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 5
NTP Experiment-Test: 05214-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC TRANS-DELTA-9-TETRAHYDROCANNABINOL Date: 05/20/95
Route: GAVAGE Time: 12:55:03
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 125 250 500
MG/KG MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (59) (59) (60) (59)
Fibrosis 1 (2%)
Hyperplasia 1 (2%)
Infiltration Cellular, Lymphocyte 1 (2%)
Inflammation, Chronic 1 (2%) 1 (2%)
Skin (60) (60) (60) (60)
Abscess 1 (2%)
Inflammation, Acute 1 (2%)
Inflammation, Chronic 2 (3%)
Inflammation, Chronic Active 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (60) (60) (60) (60)
Inflammation, Chronic 1 (2%)
Skeletal Muscle (60) (60) (60) (60)
Degeneration 6 (10%) 3 (5%) 3 (5%) 3 (5%)
Infiltration Cellular, Lymphocyte 7 (12%) 1 (2%) 2 (3%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (60) (60) (58) (60)
Infiltration Cellular, Lymphocyte 1 (2%)
Inflammation, Acute 1 (2%)
Mineralization 32 (53%) 27 (45%) 25 (43%) 23 (38%)
Hippocampus, Neuron, Necrosis 1 (2%)
Peripheral Nerve (60) (60) (60) (59)
Degeneration 1 (2%)
Infiltration Cellular, Lymphocyte 1 (2%) 2 (3%)
Perineural, Inflammation, Chronic 1 (2%)
Spinal Cord (60) (60) (60) (59)
Meninges, Inflammation, Acute 1 (2%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (59) (60) (60) (60)
Abscess 1 (2%)
Congestion 1 (2%)
Hemorrhage 3 (5%) 8 (13%) 2 (3%) 8 (13%)
Infiltration Cellular, Lymphocyte 1 (2%) 1 (2%)
Inflammation, Acute 1 (2%) 1 (2%) 1 (2%)
Inflammation, Chronic 1 (2%) 1 (2%) 2 (3%)
Inflammation, Chronic Active 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 6
NTP Experiment-Test: 05214-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC TRANS-DELTA-9-TETRAHYDROCANNABINOL Date: 05/20/95
Route: GAVAGE Time: 12:55:03
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 125 250 500
MG/KG MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM - CONT
Alveolar Epithelium, Hyperplasia 1 (2%)
Alveolus, Infiltration Cellular, Histiocyte 1 (2%) 1 (2%)
Bronchiole, Hyperplasia 1 (2%)
Nose (59) (60) (60) (60)
Foreign Body 1 (2%)
Inflammation, Acute 4 (7%) 5 (8%) 6 (10%) 1 (2%)
Inflammation, Chronic 24 (41%) 22 (37%) 19 (32%) 18 (30%)
Inflammation, Chronic Active 1 (2%)
Lumen, Exudate 2 (3%)
Nasolacrimal Duct, Hyperplasia 2 (3%) 1 (2%)
Olfactory Epithelium, Hyperplasia 1 (2%) 3 (5%) 1 (2%) 1 (2%)
Respiratory Epithelium, Hyperplasia 1 (2%)
Respiratory Epithelium, Metaplasia, Squamous 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Ear (1) (1)
Middle Ear, Inflammation, Chronic Active 1 (100%)
Mucosa, Middle Ear, Hyperplasia 1 (100%)
Eye (1)
Cornea, Inflammation, Chronic 1 (100%)
Lens, Cataract 1 (100%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (60) (60) (60) (60)
Hemorrhage 1 (2%)
Infiltration Cellular, Lymphocyte 1 (2%)
Inflammation, Chronic Active 1 (2%)
Metaplasia, Osseous 1 (2%)
Mineralization 27 (45%) 17 (28%) 6 (10%) 3 (5%)
Nephropathy 39 (65%) 22 (37%) 15 (25%) 38 (63%)
Glomerulus, Amyloid Deposition 1 (2%)
Pelvis, Inflammation, Chronic 1 (2%) 1 (2%)
Renal Tubule, Bacterium 1 (2%)
Renal Tubule, Degeneration, Hyaline 1 (2%)
Renal Tubule, Necrosis 2 (3%) 2 (3%)
Urinary Bladder (59) (60) (60) (59)
Dilatation 1 (2%) 1 (2%) 1 (2%)
Infiltration Cellular, Lymphocyte 3 (5%) 1 (2%) 1 (2%)
Inflammation, Chronic 1 (2%) 1 (2%) 2 (3%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 7
NTP Experiment-Test: 05214-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC TRANS-DELTA-9-TETRAHYDROCANNABINOL Date: 05/20/95
Route: GAVAGE Time: 12:55:03
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 125 250 500
MG/KG MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
URINARY SYSTEM - CONT
Transitional Epithelium, Hyperplasia 1 (2%) 1 (2%) 2 (3%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 8
NTP Experiment-Test: 05214-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC TRANS-DELTA-9-TETRAHYDROCANNABINOL Date: 05/20/95
Route: GAVAGE Time: 12:55:03
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 125 250 500
MG/KG MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 80 60 70 70
Scheduled Sacrifice 18 9 10
Early Deaths
Natural Death 9 5 11 21
Moribund Sacrifice 3 2 3 4
Accidently Killed 2
Dosing Accident 1
Survivors
Terminal Sacrifice 50 53 45 33
Natural Death 1
Animals Examined Microscopically 80 60 70 70
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Esophagus (62) (60) (61) (59)
Inflammation, Chronic 1 (2%)
Inflammation, Subacute 1 (2%)
Perforation 1 (2%)
Gallbladder (57) (56) (54) (53)
Dilatation 2 (4%)
Intestine Large, Cecum (60) (57) (56) (55)
Lymphoid Tissue, Hyperplasia, Lymphoid 1 (2%) 3 (5%)
Intestine Small, Duodenum (60) (57) (54) (54)
Inflammation, Chronic 1 (2%)
Intestine Small, Ileum (60) (57) (54) (54)
Lymphoid Tissue, Hyperplasia, Lymphoid 1 (2%) 1 (2%)
Liver (62) (60) (61) (57)
Angiectasis 1 (2%) 1 (2%)
Basophilic Focus 2 (3%) 2 (3%) 1 (2%) 1 (2%)
Clear Cell Focus 7 (11%) 1 (2%)
Eosinophilic Focus 18 (29%) 1 (2%)
Fatty Change 20 (32%) 11 (18%) 1 (2%) 1 (2%)
Hematopoietic Cell Proliferation 2 (3%) 1 (2%) 2 (3%) 1 (2%)
Hemorrhage 1 (2%)
Infarct 2 (3%)
Inflammation, Acute 1 (2%) 1 (2%)
Inflammation, Chronic 4 (7%)
Inflammation, Chronic Active 1 (2%)
Mixed Cell Focus 1 (2%) 2 (3%) 1 (2%)
Necrosis 2 (3%) 2 (4%)
Regeneration 1 (2%)
Bile Duct, Dilatation 1 (2%)
Mesentery (7) (1) (1) (2)
a Number of animals examined microscopically at site and number of animals with lesion
Page 9
NTP Experiment-Test: 05214-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC TRANS-DELTA-9-TETRAHYDROCANNABINOL Date: 05/20/95
Route: GAVAGE Time: 12:55:03
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 125 250 500
MG/KG MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Inflammation, Chronic Active 1 (50%)
Fat, Necrosis 6 (86%)
Pancreas (62) (59) (61) (57)
Atrophy 1 (2%) 1 (2%)
Hyperplasia, Lymphoid 1 (2%)
Infiltration Cellular, Lymphocyte 1 (2%)
Inflammation, Chronic 1 (2%) 2 (3%) 1 (2%)
Inflammation, Chronic Active 1 (2%)
Arteriole, Inflammation, Chronic 1 (2%)
Arteriole, Mineralization 1 (2%)
Duct, Hyperplasia 1 (2%)
Salivary Glands (62) (60) (61) (58)
Duct, Dilatation 1 (2%)
Stomach, Forestomach (62) (58) (58) (56)
Cyst 1 (2%)
Hyperplasia, Squamous 7 (11%) 33 (57%) 38 (66%) 18 (32%)
Infiltration Cellular, Lymphocyte 1 (2%)
Ulcer 5 (8%) 17 (29%) 14 (24%) 8 (14%)
Stomach, Glandular (62) (58) (57) (56)
Edema 1 (2%)
Erosion 3 (5%) 1 (2%) 1 (2%)
Hyperplasia 1 (2%) 2 (3%) 2 (4%) 3 (5%)
Infiltration Cellular, Lymphocyte 1 (2%)
Mineralization 1 (2%)
Tongue (1) (3) (3)
Dysplasia 1 (33%)
Epithelium, Hyperplasia, Squamous 1 (100%)
Tooth (48) (48) (43) (23)
Abscess 3 (6%) 2 (4%) 2 (9%)
Dysplasia 46 (96%) 47 (98%) 42 (98%) 23 (100%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (62) (60) (61) (60)
Bacterium 1 (2%)
Cardiomyopathy 6 (10%) 9 (15%) 6 (10%) 6 (10%)
Inflammation, Acute 1 (2%)
Inflammation, Chronic 1 (2%) 3 (5%)
Mineralization 1 (2%) 1 (2%)
Atrium, Thrombosis 1 (2%)
Endothelium, Hyperplasia 1 (2%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 10
NTP Experiment-Test: 05214-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC TRANS-DELTA-9-TETRAHYDROCANNABINOL Date: 05/20/95
Route: GAVAGE Time: 12:55:03
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 125 250 500
MG/KG MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (62) (59) (61) (59)
Focal Cellular Change 1 (2%)
Hyperplasia 14 (23%) 8 (14%) 5 (8%) 1 (2%)
Hypertrophy 10 (16%) 6 (10%) 7 (11%) 3 (5%)
Inflammation, Chronic 1 (2%)
Capsule, Hyperplasia 52 (84%) 50 (85%) 51 (84%) 45 (76%)
Capsule, Inflammation, Chronic Active 1 (2%)
Adrenal Medulla (61) (59) (61) (58)
Hyperplasia 1 (2%)
Islets, Pancreatic (62) (59) (61) (55)
Hyperplasia 41 (66%) 27 (46%) 17 (28%) 6 (11%)
Parathyroid Gland (50) (47) (50) (49)
Cyst 5 (11%) 1 (2%)
Pituitary Gland (59) (57) (59) (53)
Pars Distalis, Cyst 2 (3%) 4 (7%) 4 (7%) 2 (4%)
Pars Distalis, Hyperplasia 9 (15%) 2 (4%) 1 (2%) 4 (8%)
Thyroid Gland (62) (60) (61) (57)
Inflammation, Chronic 1 (2%)
Follicle, Cyst 1 (2%)
Follicular Cell, Hyperplasia 16 (26%) 48 (80%) 45 (74%) 27 (47%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
Tissue NOS (1)
Abscess 1 (100%)
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Epididymis (80) (60) (70) (69)
Granuloma Sperm 1 (1%) 2 (3%) 1 (1%)
Inflammation, Chronic 1 (1%)
Preputial Gland (62) (59) (60) (59)
Abscess 1 (2%) 1 (2%) 1 (2%)
Atrophy 46 (74%) 37 (63%) 25 (42%) 17 (29%)
Dilatation 3 (5%) 1 (2%)
Hyperplasia 1 (2%) 1 (2%)
Inflammation, Chronic 36 (58%) 43 (73%) 35 (58%) 23 (39%)
Inflammation, Chronic Active 1 (2%) 1 (2%)
Prostate (62) (60) (62) (60)
Abscess 1 (2%) 1 (2%)
Concretion 4 (6%) 1 (2%) 7 (12%)
Congestion 1 (2%)
Hyperplasia 1 (2%) 1 (2%)
Inflammation, Acute 2 (3%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 11
NTP Experiment-Test: 05214-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC TRANS-DELTA-9-TETRAHYDROCANNABINOL Date: 05/20/95
Route: GAVAGE Time: 12:55:03
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 125 250 500
MG/KG MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM - CONT
Inflammation, Chronic 1 (2%) 3 (5%)
Inflammation, Chronic Active 2 (3%)
Seminal Vesicle (62) (60) (62) (57)
Dilatation 7 (11%) 1 (2%)
Fibrosis 1 (2%)
Hyperplasia 2 (4%)
Testes (80) (60) (70) (69)
Atrophy 1 (1%)
Degeneration 3 (4%)
Granuloma Sperm 1 (1%) 1 (1%)
Inflammation, Chronic 1 (1%)
Mineralization 1 (1%)
Interstitial Cell, Hyperplasia 1 (1%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (62) (60) (60) (58)
Hyperplasia, Megakaryocyte 1 (2%)
Myelofibrosis 1 (2%)
Proliferation 8 (13%) 4 (7%) 5 (8%) 6 (10%)
Myeloid Cell, Proliferation 1 (2%)
Lymph Node, Mandibular (54) (50) (54) (53)
Atrophy 3 (6%) 1 (2%)
Congestion 1 (2%)
Hyperplasia, Lymphoid 1 (2%) 3 (6%)
Infiltration Cellular, Plasma Cell 1 (2%)
Lymph Node, Mesenteric (59) (55) (57) (54)
Angiectasis 5 (8%) 2 (4%) 2 (4%)
Atrophy 3 (5%) 1 (2%) 5 (9%) 1 (2%)
Congestion 1 (2%)
Ectasia 1 (2%)
Hematopoietic Cell Proliferation 3 (5%)
Hyperplasia, Lymphoid 1 (2%) 1 (2%) 1 (2%)
Inflammation, Chronic 1 (2%)
Inflammation, Chronic Active 1 (2%)
Spleen (62) (59) (61) (59)
Angiectasis 1 (2%)
Capsule, Inflammation, Chronic 1 (2%)
Lymphoid Follicle, Atrophy 4 (6%) 1 (2%) 2 (3%) 7 (12%)
Lymphoid Follicle, Hyperplasia, Lymphoid 17 (27%) 20 (34%) 11 (18%) 5 (8%)
Red Pulp, Atrophy 1 (2%)
Red Pulp, Hematopoietic Cell Proliferation 33 (53%) 14 (24%) 17 (28%) 13 (22%)
Thymus (58) (50) (55) (52)
Angiectasis 1 (2%)
Cyst 17 (29%) 12 (24%) 6 (11%) 4 (8%)
Ectopic Parathyroid Gland 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 12
NTP Experiment-Test: 05214-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC TRANS-DELTA-9-TETRAHYDROCANNABINOL Date: 05/20/95
Route: GAVAGE Time: 12:55:03
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 125 250 500
MG/KG MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - CONT
Inflammation, Chronic 1 (2%)
Necrosis 1 (2%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Skin (62) (60) (61) (61)
Abscess 1 (2%) 1 (2%)
Acanthosis 1 (2%)
Hyperkeratosis 1 (2%)
Inflammation, Chronic 1 (2%) 1 (2%)
Ulcer 1 (2%) 1 (2%)
Subcutaneous Tissue, Abscess 1 (2%)
Subcutaneous Tissue, Foreign Body 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (62) (60) (60) (60)
Hyperplasia 1 (2%)
Inflammation, Chronic 1 (2%)
Skeletal Muscle (62) (60) (61) (60)
Degeneration 10 (16%) 7 (12%) 8 (13%) 7 (12%)
Infiltration Cellular, Lymphocyte 1 (2%) 3 (5%) 2 (3%)
Inflammation, Chronic 1 (2%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (62) (60) (61) (59)
Mineralization 42 (68%) 33 (55%) 28 (46%) 23 (39%)
Cerebrum, Neuron, Necrosis 1 (2%)
Thalamus, Neuron, Necrosis 1 (2%)
Peripheral Nerve (60) (60) (61) (60)
Degeneration 2 (3%)
Spinal Cord (62) (60) (61) (59)
Degeneration 1 (2%)
Mineralization 1 (2%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (62) (60) (61) (59)
Congestion 1 (2%)
Edema 2 (3%)
Hemorrhage 3 (5%) 4 (7%) 6 (10%) 6 (10%)
Inflammation, Chronic 2 (3%) 2 (3%) 3 (5%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 13
NTP Experiment-Test: 05214-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC TRANS-DELTA-9-TETRAHYDROCANNABINOL Date: 05/20/95
Route: GAVAGE Time: 12:55:03
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 125 250 500
MG/KG MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM - CONT
Leukocytosis 1 (2%) 1 (2%)
Alveolar Epithelium, Hyperplasia 1 (2%) 1 (2%) 1 (2%)
Alveolus, Infiltration Cellular, Histiocyte 5 (8%) 2 (3%)
Bronchiole, Hyperplasia 1 (2%) 2 (3%)
Nose (62) (59) (61) (58)
Inflammation, Acute 1 (2%) 1 (2%)
Inflammation, Chronic 26 (42%) 23 (39%) 14 (23%) 13 (22%)
Glands, Hyperplasia, Glandular 1 (2%)
Lumen, Foreign Body 2 (3%)
Nasolacrimal Duct, Hyperplasia 1 (2%) 2 (3%) 3 (5%)
Nasolacrimal Duct, Inflammation, Chronic 2 (3%)
Olfactory Epithelium, Hyperplasia 4 (6%) 1 (2%) 3 (5%) 2 (3%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (1) (1) (1) (1)
Cataract 1 (100%)
Phthisis Bulbi 1 (100%)
Cornea, Fibrosis 1 (100%)
Harderian Gland (2) (4) (5) (2)
Hyperplasia 1 (25%) 2 (100%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (62) (60) (61) (60)
Bacterium 2 (3%) 2 (3%) 1 (2%)
Cyst 12 (19%) 2 (3%) 3 (5%) 7 (12%)
Hematopoietic Cell Proliferation 1 (2%)
Hydronephrosis 1 (2%)
Inflammation, Chronic Active 2 (3%) 3 (5%) 6 (10%)
Metaplasia, Osseous 1 (2%)
Mineralization 55 (89%) 56 (93%) 45 (74%) 32 (53%)
Nephropathy 61 (98%) 50 (83%) 43 (70%) 42 (70%)
Pelvis, Inflammation, Chronic 1 (2%) 2 (3%) 5 (8%) 12 (20%)
Pelvis, Transitional Epithelium, Hyperplasia 1 (2%)
Renal Tubule, Bacterium 1 (2%)
Renal Tubule, Hyperplasia 1 (2%) 1 (2%)
Renal Tubule, Pigmentation 1 (2%)
Urinary Bladder (62) (60) (62) (58)
Dilatation 6 (10%) 1 (2%) 2 (3%) 7 (12%)
Infiltration Cellular, Lymphocyte 1 (2%)
Inflammation, Chronic 4 (6%) 9 (16%)
Transitional Epithelium, Bacterium 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 14
NTP Experiment-Test: 05214-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC TRANS-DELTA-9-TETRAHYDROCANNABINOL Date: 05/20/95
Route: GAVAGE Time: 12:55:03
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 125 250 500
MG/KG MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
URINARY SYSTEM - CONT
Transitional Epithelium, Hyperplasia 2 (3%) 8 (14%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 15
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