TDMS Study 05214-01 Pathology Tables
INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)
TRANS-DELTA-9-TETRAHYDROCANNABINOL
NTP Experiment-Test: 05214-01 Report: PEIRPT03
Study Type: CHRONIC Date: 05/20/95
Route: GAVAGE Time: 12:11:42
Facility: TSI Mason Research
Chemical CAS #: 1972-08-3
Lock Date: 06/17/92
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: 05214-01 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: 12:11:42
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 12.5 25 50
MG/KG MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 60 60 60 60
Scheduled Sacrifice 9 9 9 10
Early Deaths
Moribund Sacrifice 18 9 9 10
Natural Death 8 2 6 5
Dosing Accident 2 3 1
Accidently Killed 2
Survivors
Moribund Sacrifice 1
Natural Death 1 1
Terminal Sacrifice 23 39 33 30
Animals Examined Microscopically 60 60 60 60
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Esophagus (60) (60) (60) (60)
Hemorrhage 1 (2%)
Ulcer 1 (2%)
Intestine Large, Colon (58) (59) (60) (57)
Dilatation 1 (2%)
Intestine Large, Rectum (55) (59) (59) (57)
Dilatation 1 (2%)
Intestine Large, Cecum (54) (59) (58) (57)
Dilatation 1 (2%)
Mineralization 1 (2%)
Lymphoid Tissue, Hyperplasia, Lymphoid 1 (2%)
Intestine Small, Duodenum (59) (60) (59) (57)
Ectopic Tissue 1 (2%)
Liver (60) (60) (60) (60)
Angiectasis 1 (2%) 1 (2%) 1 (2%)
Basophilic Focus 52 (87%) 52 (87%) 51 (85%) 51 (85%)
Clear Cell Focus 19 (32%) 21 (35%) 22 (37%) 15 (25%)
Congestion 2 (3%)
Cyst 1 (2%) 1 (2%)
Developmental Malformation 1 (2%)
Eosinophilic Focus 3 (5%) 7 (12%) 4 (7%) 9 (15%)
Fatty Change 7 (12%) 1 (2%) 1 (2%)
Fatty Change, Focal 2 (3%)
Hematopoietic Cell Proliferation 1 (2%)
Hepatodiaphragmatic Nodule 14 (23%) 13 (22%) 9 (15%) 9 (15%)
Hepatodiaphragmatic Nodule, Multiple 1 (2%)
Hyperplasia 2 (3%) 6 (10%) 7 (12%) 5 (8%)
Inflammation, Chronic 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 2
NTP Experiment-Test: 05214-01 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: 12:11:42
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 12.5 25 50
MG/KG MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Inflammation, Chronic Active 1 (2%)
Mixed Cell Focus 3 (5%) 5 (8%) 2 (3%) 7 (12%)
Necrosis 2 (3%) 1 (2%)
Pigmentation 1 (2%)
Serosa, Fibrosis 1 (2%)
Mesentery (6) (5) (2) (1)
Fat, Fibrosis 1 (100%)
Fat, Hemorrhage 1 (20%) 1 (100%)
Fat, Necrosis 5 (83%) 4 (80%) 2 (100%)
Fat, Pigmentation 1 (17%)
Pancreas (60) (60) (60) (59)
Cyst 1 (2%)
Ectopic Tissue 2 (3%)
Inflammation, Chronic 1 (2%)
Metaplasia 1 (2%) 2 (3%)
Acinus, Atrophy 27 (45%) 27 (45%) 23 (38%) 31 (53%)
Acinus, Hyperplasia 1 (2%) 1 (2%) 1 (2%)
Artery, Inflammation, Chronic Active 1 (2%)
Salivary Glands (60) (60) (59) (60)
Degeneration 1 (2%)
Focal Cellular Change 3 (5%) 4 (7%)
Duct, Inflammation, Acute 1 (2%)
Duct, Metaplasia, Squamous 5 (8%) 1 (2%) 2 (3%) 3 (5%)
Duct, Mineralization 1 (2%)
Stomach, Forestomach (60) (60) (60) (60)
Dilatation 1 (2%)
Edema 1 (2%)
Hemorrhage 1 (2%)
Hyperkeratosis 2 (3%) 2 (3%) 1 (2%)
Hyperplasia, Basal Cell 6 (10%) 4 (7%) 6 (10%) 3 (5%)
Hyperplasia, Cystic 1 (2%)
Hyperplasia, Focal, Squamous 1 (2%)
Inflammation, Acute 1 (2%) 1 (2%) 1 (2%)
Inflammation, Chronic 1 (2%) 1 (2%) 1 (2%)
Inflammation, Chronic Active 1 (2%)
Perforation 1 (2%)
Ulcer 4 (7%) 2 (3%) 1 (2%) 3 (5%)
Stomach, Glandular (60) (60) (60) (58)
Erosion 1 (2%) 1 (2%) 1 (2%) 4 (7%)
Hyperplasia 1 (2%)
Ulcer 1 (2%) 1 (2%) 1 (2%)
Tooth (1)
Foreign Body 1 (100%)
Inflammation, Chronic Active 1 (100%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 3
NTP Experiment-Test: 05214-01 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: 12:11:42
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 12.5 25 50
MG/KG MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (60) (60) (60) (60)
Cardiomyopathy 48 (80%) 49 (82%) 49 (82%) 50 (83%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (60) (60) (60) (60)
Angiectasis 1 (2%)
Clear Cell Focus 3 (5%)
Congestion 1 (2%)
Focal Cellular Change 2 (3%) 1 (2%)
Hyperplasia 2 (3%) 5 (8%) 4 (7%) 2 (3%)
Hypertrophy 1 (2%)
Adrenal Medulla (60) (60) (60) (60)
Hemorrhage 1 (2%)
Hyperplasia 3 (5%) 3 (5%) 3 (5%) 2 (3%)
Islets, Pancreatic (60) (60) (60) (59)
Hyperplasia 1 (2%)
Parathyroid Gland (57) (56) (57) (52)
Hyperplasia 1 (2%)
Pituitary Gland (60) (60) (60) (60)
Pars Distalis, Angiectasis 4 (7%) 5 (8%) 7 (12%) 5 (8%)
Pars Distalis, Cyst 22 (37%) 30 (50%) 29 (48%) 24 (40%)
Pars Distalis, Hyperplasia 25 (42%) 18 (30%) 12 (20%) 22 (37%)
Pars Intermedia, Atypia Cellular 1 (2%)
Pars Intermedia, Cyst 1 (2%) 1 (2%)
Thyroid Gland (60) (60) (60) (60)
Cyst 1 (2%) 1 (2%)
C-Cell, Hyperplasia 17 (28%) 19 (32%) 14 (23%) 12 (20%)
Follicular Cell, Hyperplasia 1 (2%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
Tissue NOS (1)
Mediastinum, Granuloma 1 (100%)
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Clitoral Gland (57) (55) (60) (59)
Abscess 1 (2%)
Cyst 2 (4%) 5 (8%) 1 (2%)
Dilatation 2 (4%) 1 (2%) 1 (2%)
Hyperplasia 3 (5%) 2 (3%) 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: 05214-01 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: 12:11:42
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 12.5 25 50
MG/KG MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM - CONT
Inflammation, Chronic 1 (2%)
Inflammation, Chronic Active 2 (3%)
Ovary (60) (59) (59) (60)
Cyst 6 (10%) 11 (19%) 5 (8%) 7 (12%)
Uterus (60) (60) (59) (60)
Dilatation 4 (7%) 5 (8%) 7 (12%) 2 (3%)
Hemorrhage 1 (2%)
Hyperplasia, Glandular 1 (2%)
Inflammation, Acute 1 (2%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (60) (60) (60) (60)
Hyperplasia, Re Cell 1 (2%) 1 (2%)
Myelofibrosis 1 (2%)
Lymph Node (6) (6) (10) (7)
Lumbar, Necrosis 1 (14%)
Mediastinal, Angiectasis 2 (33%) 1 (17%) 3 (30%)
Mediastinal, Ectasia 1 (17%)
Mediastinal, Hyperplasia, Lymphoid 1 (14%)
Mediastinal, Pigmentation 1 (17%) 1 (17%) 3 (30%)
Pancreatic, Ectasia 1 (10%)
Pancreatic, Infiltration Cellular, Histiocyte 1 (10%)
Lymph Node, Mandibular (60) (60) (59) (60)
Hyperplasia 1 (2%)
Hyperplasia, Lymphoid 1 (2%)
Infiltration Cellular, Plasma Cell 2 (3%) 3 (5%)
Necrosis 1 (2%)
Lymph Node, Mesenteric (59) (60) (60) (60)
Angiectasis 1 (2%)
Ectasia 1 (2%)
Hyperplasia, Lymphoid 1 (2%)
Necrosis 1 (2%)
Spleen (60) (60) (60) (60)
Depletion Lymphoid 1 (2%) 1 (2%)
Fibrosis 1 (2%) 1 (2%)
Hematopoietic Cell Proliferation 3 (5%) 1 (2%) 1 (2%)
Hyperplasia, Re Cell 1 (2%)
Necrosis 1 (2%)
Pigmentation 1 (2%) 1 (2%)
Capsule, Fibrosis 1 (2%)
Thymus (55) (56) (59) (57)
Cyst 1 (2%)
Ectopic Thyroid 1 (2%)
Hemorrhage 1 (2%)
Necrosis 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 5
NTP Experiment-Test: 05214-01 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: 12:11:42
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 12.5 25 50
MG/KG MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (60) (58) (59) (56)
Galactocele 4 (7%) 7 (12%) 5 (9%)
Hyperplasia 1 (2%)
Skin (60) (60) (60) (60)
Abscess 1 (2%)
Acanthosis 1 (2%)
Cyst Epithelial Inclusion 2 (3%) 1 (2%) 1 (2%)
Erosion 1 (2%)
Hyperkeratosis 2 (3%)
Inflammation, Chronic 1 (2%)
Inflammation, Chronic Active 1 (2%)
Ulcer 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (60) (60) (60) (60)
Developmental Malformation 1 (2%)
Hyperostosis 1 (2%)
Skeletal Muscle (60) (60) (59) (60)
Atrophy 1 (2%) 1 (2%)
Inflammation, Chronic Active 1 (2%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (60) (60) (60) (60)
Mineralization 2 (3%)
Cerebrum, Neuron, Necrosis 1 (2%)
Hippocampus, Neuron, Necrosis 1 (2%)
Spinal Cord (60) (60) (60) (60)
Hemorrhage 1 (2%) 1 (2%)
Inflammation, Acute 1 (2%)
Necrosis 1 (2%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (60) (60) (60) (60)
Congestion 1 (2%)
Edema 3 (5%) 1 (2%) 4 (7%) 3 (5%)
Foreign Body 15 (25%) 13 (22%) 19 (32%) 12 (20%)
Hemorrhage 1 (2%) 3 (5%) 4 (7%) 2 (3%)
Infiltration Cellular, Histiocyte 7 (12%) 2 (3%) 4 (7%) 7 (12%)
Inflammation, Chronic Active 28 (47%) 51 (85%) 48 (80%) 46 (77%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 6
NTP Experiment-Test: 05214-01 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: 12:11:42
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 12.5 25 50
MG/KG MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM - CONT
Alveolar Epithelium, Hyperplasia 1 (2%) 2 (3%)
Mediastinum, Inflammation, Acute 1 (2%)
Pleura, Bacterium 1 (2%)
Pleura, Inflammation, Acute 1 (2%)
Nose (60) (60) (60) (60)
Bacterium 2 (3%) 1 (2%)
Foreign Body 1 (2%) 1 (2%) 5 (8%)
Fungus 1 (2%) 1 (2%) 1 (2%) 1 (2%)
Inflammation, Acute 13 (22%) 6 (10%) 8 (13%) 7 (12%)
Respiratory Epithelium, Metaplasia 1 (2%)
Trachea (60) (60) (60) (60)
Inflammation, Chronic 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (3) (3) (3) (1)
Phthisis Bulbi 1 (33%) 1 (33%)
Synechia 1 (33%) 2 (67%)
Lens, Cataract 3 (100%) 2 (67%) 1 (33%)
Retina, Atrophy 1 (33%) 1 (33%) 1 (33%) 1 (100%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (60) (60) (60) (60)
Nephropathy 43 (72%) 41 (68%) 42 (70%) 39 (65%)
Pigmentation 1 (2%)
Cortex, Mineralization 25 (42%) 18 (30%) 22 (37%) 20 (33%)
Renal Tubule, Degeneration, Hyaline 1 (2%) 1 (2%)
Renal Tubule, Hyperplasia 1 (2%)
Transitional Epithelium, Hyperplasia 1 (2%)
Urinary Bladder (60) (60) (60) (59)
Transitional Epithelium, Hyperplasia 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 7
NTP Experiment-Test: 05214-01 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: 12:11:42
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 12.5 25 50
MG/KG MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 80 60 70 70
Scheduled Sacrifice 10 9 9 9
Early Deaths
Moribund Sacrifice 19 8 11 10
Natural Death 10 8 6 10
Dosing Accident 1 2
Accidently Killed 1
Survivors
Natural Death 1
Terminal Sacrifice 22 35 33 30
Special Study 18 9 9
Animals Examined Microscopically 62 60 61 61
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Esophagus (62) (60) (61) (61)
Abscess 1 (2%)
Perforation 1 (2%) 2 (3%)
Intestine Large, Colon (62) (58) (59) (58)
Bacterium 1 (2%)
Dilatation 1 (2%)
Intestine Large, Cecum (55) (57) (59) (56)
Bacterium 1 (2%)
Dilatation 2 (4%) 1 (2%)
Ulcer 1 (2%)
Intestine Small, Ileum (58) (58) (60) (55)
Dilatation 1 (2%)
Liver (62) (60) (61) (61)
Bacterium 1 (2%)
Basophilic Focus 23 (37%) 20 (33%) 27 (44%) 22 (36%)
Clear Cell Focus 33 (53%) 34 (57%) 37 (61%) 36 (59%)
Congestion 1 (2%)
Cyst 1 (2%) 1 (2%)
Developmental Malformation 1 (2%)
Eosinophilic Focus 7 (11%) 8 (13%) 2 (3%) 5 (8%)
Fatty Change 1 (2%)
Fatty Change, Diffuse 1 (2%) 1 (2%)
Fatty Change, Focal 14 (23%) 17 (28%) 18 (30%) 13 (21%)
Hepatodiaphragmatic Nodule 3 (5%) 6 (10%) 9 (15%) 2 (3%)
Hyperplasia 1 (2%) 1 (2%)
Mixed Cell Focus 1 (2%) 2 (3%) 5 (8%) 3 (5%)
Necrosis 1 (2%) 2 (3%) 1 (2%)
Vein, Dilatation 2 (3%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 8
NTP Experiment-Test: 05214-01 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: 12:11:42
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 12.5 25 50
MG/KG MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Mesentery (6) (5) (3) (4)
Artery, Inflammation, Chronic Active 1 (25%)
Fat, Fibrosis 1 (20%) 1 (33%)
Fat, Hemorrhage 1 (20%)
Fat, Inflammation, Chronic Active 1 (17%) 1 (33%) 1 (25%)
Fat, Mineralization 1 (33%)
Fat, Necrosis 4 (67%) 4 (80%) 1 (33%)
Pancreas (62) (60) (61) (61)
Bacterium 1 (2%)
Metaplasia 1 (2%) 1 (2%)
Acinus, Atrophy 30 (48%) 31 (52%) 30 (49%) 30 (49%)
Acinus, Hyperplasia 21 (34%) 10 (17%) 3 (5%) 3 (5%)
Artery, Hyperplasia 1 (2%)
Artery, Inflammation, Chronic Active 2 (3%) 1 (2%) 1 (2%)
Artery, Pigmentation 1 (2%)
Salivary Glands (62) (60) (61) (61)
Hemorrhage 1 (2%)
Acinus, Atrophy 1 (2%)
Duct, Metaplasia, Squamous 9 (15%) 6 (10%) 4 (7%) 7 (11%)
Stomach, Forestomach (62) (59) (61) (61)
Erosion 1 (2%) 1 (2%)
Hyperkeratosis 1 (2%) 1 (2%)
Hyperplasia, Basal Cell 1 (2%)
Hyperplasia, Cystic 1 (2%)
Hyperplasia, Diffuse, Squamous 11 (18%) 3 (5%) 6 (10%) 1 (2%)
Hyperplasia, Focal, Squamous 1 (2%) 2 (3%) 1 (2%)
Ulcer 9 (15%) 1 (2%) 7 (11%)
Stomach, Glandular (62) (60) (61) (58)
Bacterium 1 (2%)
Erosion 10 (16%) 7 (12%) 4 (7%) 4 (7%)
Hyperplasia 1 (2%) 2 (3%) 2 (3%) 2 (3%)
Hyperplasia, Lymphoid 1 (2%) 1 (2%)
Inflammation, Chronic 1 (2%)
Inflammation, Chronic Active 1 (2%)
Mineralization 2 (3%)
Ulcer 3 (5%) 2 (3%)
Tooth (1)
Abscess 1 (100%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (62) (60) (61) (61)
Bacterium 1 (2%) 1 (2%)
Cardiomyopathy 60 (97%) 55 (92%) 56 (92%) 56 (92%)
Inflammation, Acute 1 (2%)
Mineralization 2 (3%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 9
NTP Experiment-Test: 05214-01 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: 12:11:42
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 12.5 25 50
MG/KG MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM - CONT
Thrombosis 1 (2%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (62) (60) (61) (61)
Hyperplasia 1 (2%)
Hypertrophy 1 (2%)
Necrosis 1 (2%)
Adrenal Medulla (62) (60) (61) (61)
Bacterium 1 (2%)
Hyperplasia 21 (34%) 14 (23%) 17 (28%) 15 (25%)
Necrosis 1 (2%)
Islets, Pancreatic (62) (60) (61) (61)
Hyperplasia 5 (8%) 1 (2%) 1 (2%) 1 (2%)
Parathyroid Gland (58) (55) (53) (56)
Hyperplasia 1 (2%)
Pituitary Gland (62) (60) (60) (61)
Pars Distalis, Angiectasis 4 (7%) 1 (2%) 1 (2%)
Pars Distalis, Cyst 3 (5%) 7 (12%) 12 (20%) 9 (15%)
Pars Distalis, Hemorrhage 1 (2%) 1 (2%)
Pars Distalis, Hyperplasia 17 (27%) 22 (37%) 21 (35%) 22 (36%)
Pars Intermedia, Cyst 2 (3%) 1 (2%)
Thyroid Gland (62) (59) (60) (59)
Congestion 1 (2%)
C-Cell, Hyperplasia 11 (18%) 9 (15%) 9 (15%) 8 (14%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Epididymis (62) (60) (61) (61)
Atypia Cellular 1 (2%)
Degeneration 1 (2%)
Preputial Gland (62) (60) (61) (59)
Dilatation 3 (5%) 1 (2%)
Hyperplasia 1 (2%)
Inflammation, Chronic Active 1 (2%)
Prostate (62) (60) (61) (61)
Abscess 1 (2%) 1 (2%)
Concretion 1 (2%)
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 10
NTP Experiment-Test: 05214-01 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: 12:11:42
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 12.5 25 50
MG/KG MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM - CONT
Seminal Vesicle (62) (60) (61) (61)
Atrophy 5 (8%) 1 (2%) 1 (2%) 1 (2%)
Concretion 2 (3%) 1 (2%)
Testes (62) (60) (61) (61)
Inflammation 2 (3%) 1 (2%) 1 (2%)
Interstitial Cell, Hyperplasia 13 (21%) 28 (47%) 25 (41%) 30 (49%)
Seminiferous Tubule, Atrophy 7 (11%) 5 (8%) 9 (15%) 5 (8%)
Seminiferous Tubule, Mineralization 1 (2%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (62) (60) (61) (61)
Degeneration 1 (2%)
Fibrosis 1 (2%)
Lymph Node (14) (5) (5) (3)
Mediastinal, Angiectasis 1 (7%) 1 (20%) 1 (33%)
Mediastinal, Ectasia 1 (7%)
Mediastinal, Infiltration Cellular,
Histiocyte 1 (7%)
Mediastinal, Pigmentation 1 (7%) 1 (33%)
Pancreatic, Degeneration 1 (20%)
Pancreatic, Hyperplasia, Lymphoid 1 (7%)
Lymph Node, Mandibular (62) (59) (61) (61)
Ectasia 1 (2%)
Hematopoietic Cell Proliferation 1 (2%)
Hyperplasia 2 (3%)
Infiltration Cellular, Histiocyte 1 (2%)
Lymph Node, Mesenteric (62) (60) (61) (61)
Congestion 1 (2%)
Infiltration Cellular 1 (2%)
Infiltration Cellular, Histiocyte 1 (2%)
Artery, Inflammation, Chronic Active 1 (2%)
Spleen (62) (60) (61) (60)
Angiectasis 1 (2%)
Bacterium 1 (2%)
Congestion 1 (2%) 1 (2%)
Depletion Lymphoid 1 (2%) 1 (2%) 1 (2%)
Fibrosis 2 (3%) 4 (7%)
Hematopoietic Cell Proliferation 1 (2%) 2 (3%)
Necrosis 2 (3%) 1 (2%)
Pigmentation 3 (5%) 2 (3%) 2 (3%)
Capsule, Necrosis 1 (2%)
Thymus (59) (57) (55) (57)
Depletion Lymphoid 1 (2%)
Fibrosis 1 (2%)
Inflammation, Chronic Active 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 11
NTP Experiment-Test: 05214-01 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: 12:11:42
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 12.5 25 50
MG/KG MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - CONT
Epithelial Cell, Hyperplasia 1 (2%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (43) (52) (52) (46)
Fibrosis 2 (4%)
Galactocele 3 (7%) 2 (4%) 1 (2%)
Hemorrhage 2 (4%)
Hyperplasia 1 (2%)
Inflammation, Chronic Active 1 (2%)
Skin (62) (60) (61) (61)
Abscess 1 (2%)
Acanthosis 1 (2%)
Cyst Epithelial Inclusion 1 (2%) 1 (2%)
Hemorrhage 1 (2%)
Hyperkeratosis 1 (2%)
Thrombosis 1 (2%)
Ulcer 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (62) (60) (61) (61)
Fracture 1 (2%) 1 (2%)
Hyperostosis 1 (2%)
Skeletal Muscle (62) (60) (60) (61)
Atrophy 1 (2%) 1 (2%) 1 (2%) 2 (3%)
Mineralization 1 (2%)
Necrosis 1 (2%)
Pigmentation 1 (2%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (62) (59) (61) (61)
Congestion 1 (2%)
Gliosis, Focal 1 (2%)
Hemorrhage 2 (3%) 1 (2%)
Mineralization 1 (2%) 1 (2%)
Cerebellum, Neuron, Necrosis 1 (2%) 1 (2%)
Hippocampus, Neuron, Necrosis 4 (6%) 1 (2%)
Spinal Cord (62) (59) (58) (59)
Cyst 1 (2%)
Hemorrhage 1 (2%)
Inflammation, Acute 1 (2%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 12
NTP Experiment-Test: 05214-01 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: 12:11:42
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 12.5 25 50
MG/KG MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (62) (60) (61) (61)
Bacterium 1 (2%) 1 (2%) 1 (2%)
Congestion 1 (2%) 2 (3%) 1 (2%)
Edema 1 (2%) 1 (2%) 3 (5%) 1 (2%)
Fibrosis 1 (2%) 1 (2%)
Foreign Body 8 (13%) 26 (43%) 26 (43%) 15 (25%)
Granuloma 1 (2%)
Hemorrhage 2 (3%) 2 (3%) 1 (2%) 7 (11%)
Infiltration Cellular, Histiocyte 4 (6%) 5 (8%) 5 (8%) 8 (13%)
Inflammation, Acute 3 (5%) 1 (2%)
Inflammation, Chronic Active 40 (65%) 44 (73%) 43 (70%) 39 (64%)
Alveolar Epithelium, Hyperplasia 1 (2%) 2 (3%) 4 (7%) 2 (3%)
Mediastinum, Bacterium 1 (2%)
Mediastinum, Inflammation, Chronic Active 1 (2%)
Pleura, Inflammation, Acute 1 (2%)
Nose (62) (60) (61) (61)
Bacterium 1 (2%)
Cyst 1 (2%)
Foreign Body 1 (2%) 3 (5%) 3 (5%) 5 (8%)
Fungus 14 (23%) 4 (7%) 3 (5%) 6 (10%)
Inflammation, Acute 28 (45%) 15 (25%) 15 (25%) 15 (25%)
Respiratory Epithelium, Metaplasia, Squamous 6 (10%) 2 (3%) 2 (3%)
Trachea (62) (60) (61) (61)
Abscess 1 (2%)
Erosion 1 (2%)
Hemorrhage 1 (2%)
Perforation 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (18) (22) (17) (21)
Hemorrhage 1 (6%)
Inflammation, Chronic Active 1 (6%)
Lens, Cataract 18 (100%) 21 (95%) 16 (94%) 20 (95%)
Retina, Atrophy 2 (9%) 1 (5%)
Harderian Gland (1)
Hyperplasia 1 (100%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 13
NTP Experiment-Test: 05214-01 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: 12:11:42
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 12.5 25 50
MG/KG MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (62) (60) (61) (61)
Bacterium 1 (2%)
Cyst 6 (10%) 1 (2%)
Degeneration 1 (2%)
Hydronephrosis 1 (2%)
Inflammation, Acute 1 (2%)
Necrosis 1 (2%)
Nephropathy 61 (98%) 57 (95%) 56 (92%) 56 (92%)
Cortex, Mineralization 4 (6%) 1 (2%) 1 (2%)
Renal Tubule, Degeneration, Hyaline 1 (2%)
Transitional Epithelium, Hyperplasia 1 (2%)
Urinary Bladder (61) (60) (61) (61)
Calculus Gross Observation 2 (3%) 1 (2%) 2 (3%) 1 (2%)
Calculus Micro Observation Only 2 (3%) 1 (2%) 3 (5%) 2 (3%)
Hemorrhage 1 (2%) 1 (2%)
Hyperplasia 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 14
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