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 ------------------------------------------------------------ ---------- END OF REPORT ---------- ------------------------------------------------------------