TDMS Study 05214-01 Pathology Tables
INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)
TRANS-DELTA-9-TETRAHYDROCANNABINOL
NTP Experiment-Test: 05214-01 Report: PEIRPT05
Study Type: CHRONIC Date: 05/20/95
Route: GAVAGE Time: 12:11:43
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 NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC TRANS-DELTA-9-TETRAHYDROCANNABINOL Date: 05/20/95
Route: GAVAGE Time: 12:11:43
____________________________________________________________________________________________________________________________________
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
Intestine Large, Cecum (54) (59) (58) (57)
Liver (60) (60) (60) (60)
Hepatocellular Adenoma 3 (5%)
Histiocytic Sarcoma 1 (2%)
Mesentery (6) (5) (2) (1)
Oral Mucosa (1)
Squamous Cell Carcinoma 1 (100%)
Pancreas (60) (60) (60) (59)
Histiocytic Sarcoma 1 (2%)
Salivary Glands (60) (60) (59) (60)
Carcinoma 1 (2%)
Stomach, Forestomach (60) (60) (60) (60)
Squamous Cell Papilloma 1 (2%)
Stomach, Glandular (60) (60) (60) (58)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (60) (60) (60) (60)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (60) (60) (60) (60)
Histiocytic Sarcoma 1 (2%)
Adrenal Medulla (60) (60) (60) (60)
Pheochromocytoma Malignant 1 (2%)
Page 2
NTP Experiment-Test: 05214-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC TRANS-DELTA-9-TETRAHYDROCANNABINOL Date: 05/20/95
Route: GAVAGE Time: 12:11:43
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 12.5 25 50
MG/KG MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM - cont
Pheochromocytoma Benign 2 (3%) 2 (3%) 2 (3%) 1 (2%)
Islets, Pancreatic (60) (60) (60) (59)
Adenoma 1 (2%) 1 (2%)
Carcinoma 1 (2%)
Pituitary Gland (60) (60) (60) (60)
Pars Distalis, Adenoma 26 (43%) 28 (47%) 32 (53%) 19 (32%)
Pars Distalis, Carcinoma 1 (2%)
Thyroid Gland (60) (60) (60) (60)
C-Cell, Adenoma 3 (5%) 2 (3%) 1 (2%)
C-Cell, Carcinoma 1 (2%)
Follicular Cell, Adenoma 1 (2%) 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Clitoral Gland (57) (55) (60) (59)
Adenoma 3 (5%) 4 (7%) 2 (3%) 3 (5%)
Bilateral, Adenoma 1 (2%) 2 (3%)
Ovary (60) (59) (59) (60)
Granulosa Cell Tumor Benign 1 (2%) 1 (2%)
Histiocytic Sarcoma 1 (2%)
Uterus (60) (60) (59) (60)
Polyp Stromal 9 (15%) 4 (7%) 3 (5%) 3 (5%)
Polyp Stromal, Multiple 1 (2%)
Sarcoma Stromal 1 (2%)
Schwannoma Malignant 1 (2%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (60) (60) (60) (60)
Histiocytic Sarcoma 1 (2%)
Lymph Node (6) (6) (10) (7)
Mediastinal, Histiocytic Sarcoma 1 (17%)
Lymph Node, Mandibular (60) (60) (59) (60)
Carcinoma, Metastatic, Salivary Glands 1 (2%)
Histiocytic Sarcoma 1 (2%)
Lymph Node, Mesenteric (59) (60) (60) (60)
Spleen (60) (60) (60) (60)
Histiocytic Sarcoma 1 (2%)
Thymus (55) (56) (59) (57)
____________________________________________________________________________________________________________________________________
Page 3
NTP Experiment-Test: 05214-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC TRANS-DELTA-9-TETRAHYDROCANNABINOL Date: 05/20/95
Route: GAVAGE Time: 12:11:43
____________________________________________________________________________________________________________________________________
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)
Adenocarcinoma 1 (2%) 1 (2%)
Adenoma 1 (2%)
Adenoma, Multiple 1 (2%)
Fibroadenoma 16 (27%) 8 (14%) 10 (17%) 6 (11%)
Fibroadenoma, Multiple 3 (5%) 1 (2%) 2 (4%)
Skin (60) (60) (60) (60)
Basal Cell Adenoma 1 (2%)
Keratoacanthoma 1 (2%)
Squamous Cell Carcinoma 1 (2%)
Subcutaneous Tissue, Fibrosarcoma 1 (2%)
Subcutaneous Tissue, Histiocytic Sarcoma 1 (2%)
Subcutaneous Tissue, Sarcoma 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Skeletal Muscle (60) (60) (59) (60)
Rhabdomyosarcoma 1 (2%)
Sarcoma 1 (2%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (60) (60) (60) (60)
Astrocytoma Malignant 1 (2%) 1 (2%)
Carcinoma, Metastatic, Pituitary Gland 1 (2%)
Meningioma Malignant 1 (2%)
Oligodendroglioma NOS 1 (2%)
Spinal Cord (60) (60) (60) (60)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (60) (60) (60) (60)
Carcinoma, Metastatic, Salivary Glands 1 (2%)
Carcinoma, Metastatic, Thyroid Gland 1 (2%)
Histiocytic Sarcoma 1 (2%)
Alveolar Epithelium, Alveolar/Bronchiolar
Adenoma 1 (2%)
Nose (60) (60) (60) (60)
Trachea (60) (60) (60) (60)
Carcinoma, Metastatic, Salivary Glands 1 (2%)
____________________________________________________________________________________________________________________________________
Page 4
NTP Experiment-Test: 05214-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC TRANS-DELTA-9-TETRAHYDROCANNABINOL Date: 05/20/95
Route: GAVAGE Time: 12:11:43
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 12.5 25 50
MG/KG MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
None
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (60) (60) (60) (60)
Histiocytic Sarcoma 1 (2%)
Urinary Bladder (60) (60) (60) (59)
____________________________________________________________________________________________________________________________________
SYSTEMIC LESIONS
Multiple Organs *(60) *(60) *(60) *(60)
Histiocytic Sarcoma 1 (2%)
Leukemia Mononuclear 9 (15%) 17 (28%) 20 (33%) 13 (22%)
____________________________________________________________________________________________________________________________________
* Number of animals with any tissue examined microscopically
Page 5
NTP Experiment-Test: 05214-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC TRANS-DELTA-9-TETRAHYDROCANNABINOL Date: 05/20/95
Route: GAVAGE Time: 12:11:43
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 12.5 25 50
MG/KG MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
TUMOR SUMMARY
Total Animals with Primary Neoplasms (b) 47 43 45 36
Total Primary Neoplasms 85 79 76 55
Total Animals with Benign Neoplasms 43 38 37 27
Total Benign Neoplasms 65 55 55 40
Total Animals with Malignant Neoplasms 18 23 20 15
Total Malignant Neoplasms 19 24 21 15
Total Animals with Metastatic Neoplasms 2 1
Total Metastatic Neoplasm 4 1
Total Animals with Malignant Neoplasms
Uncertain Primary Site
Total Animals with Neoplasms Uncertain-
Benign or Malignant 1
Total Uncertain Neoplasms 1
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
b Primary tumors: all tumors except metastatic tumors
Page 6
NTP Experiment-Test: 05214-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC TRANS-DELTA-9-TETRAHYDROCANNABINOL Date: 05/20/95
Route: GAVAGE Time: 12:11:43
____________________________________________________________________________________________________________________________________
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
Intestine Large, Colon (62) (58) (59) (58)
Carcinoma 1 (2%)
Intestine Large, Cecum (55) (57) (59) (56)
Intestine Small, Duodenum (61) (59) (60) (58)
Sarcoma 1 (2%)
Intestine Small, Ileum (58) (58) (60) (55)
Liver (62) (60) (61) (61)
Cholangioma 1 (2%)
Fibrous Histiocytoma 1 (2%)
Hepatocellular Carcinoma 2 (3%)
Hepatocellular Adenoma 3 (5%) 1 (2%) 1 (2%) 2 (3%)
Mesentery (6) (5) (3) (4)
Sarcoma 1 (33%)
Pancreas (62) (60) (61) (61)
Mixed Tumor Benign 1 (2%)
Acinus, Adenoma 7 (11%) 2 (3%)
Acinus, Adenoma, Multiple 1 (2%)
Salivary Glands (62) (60) (61) (61)
Schwannoma Malignant 1 (2%)
Stomach, Forestomach (62) (59) (61) (61)
Squamous Cell Carcinoma 1 (2%)
Squamous Cell Papilloma 1 (2%) 1 (2%)
Stomach, Glandular (62) (60) (61) (58)
____________________________________________________________________________________________________________________________________
Page 7
NTP Experiment-Test: 05214-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC TRANS-DELTA-9-TETRAHYDROCANNABINOL Date: 05/20/95
Route: GAVAGE Time: 12:11:43
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 12.5 25 50
MG/KG MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (62) (60) (61) (61)
Fibrous Histiocytoma 1 (2%)
Thymoma Malignant, Metastatic, Thymus 1 (2%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (62) (60) (61) (61)
Adenoma 1 (2%)
Thymoma Malignant, Metastatic, Thymus 1 (2%)
Adrenal Medulla (62) (60) (61) (61)
Pheochromocytoma Malignant 1 (2%) 3 (5%) 1 (2%)
Pheochromocytoma Benign 9 (15%) 6 (10%) 4 (7%) 6 (10%)
Islets, Pancreatic (62) (60) (61) (61)
Adenoma 5 (8%) 3 (5%) 4 (7%) 3 (5%)
Parathyroid Gland (58) (55) (53) (56)
Adenoma 1 (2%)
Pituitary Gland (62) (60) (60) (61)
Pars Distalis, Adenoma 22 (35%) 21 (35%) 16 (27%) 9 (15%)
Pars Intermedia, Adenoma 1 (2%)
Thyroid Gland (62) (59) (60) (59)
C-Cell, Adenoma 3 (5%) 7 (12%) 2 (3%) 4 (7%)
Follicular Cell, Adenoma 1 (2%) 1 (2%) 2 (3%)
Follicular Cell, Carcinoma 1 (2%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Epididymis (62) (60) (61) (61)
Preputial Gland (62) (60) (61) (59)
Adenoma 2 (3%) 2 (3%) 1 (2%)
Bilateral, Adenoma 1 (2%)
Prostate (62) (60) (61) (61)
Seminal Vesicle (62) (60) (61) (61)
Testes (62) (60) (61) (61)
Bilateral, Interstitial Cell, Adenoma 48 (77%) 27 (45%) 29 (48%) 21 (34%)
Interstitial Cell, Adenoma 7 (11%) 14 (23%) 7 (11%) 22 (36%)
____________________________________________________________________________________________________________________________________
Page 8
NTP Experiment-Test: 05214-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC TRANS-DELTA-9-TETRAHYDROCANNABINOL Date: 05/20/95
Route: GAVAGE Time: 12:11:43
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 12.5 25 50
MG/KG MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (62) (60) (61) (61)
Lymph Node (14) (5) (5) (3)
Lymph Node, Mandibular (62) (59) (61) (61)
Lymph Node, Mesenteric (62) (60) (61) (61)
Fibrous Histiocytoma 1 (2%)
Spleen (62) (60) (61) (60)
Histiocytic Sarcoma 1 (2%)
Sarcoma 1 (2%)
Thymus (59) (57) (55) (57)
Thymoma Benign 1 (2%)
Thymoma Malignant 1 (2%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (43) (52) (52) (46)
Carcinoma 1 (2%) 1 (2%)
Fibroadenoma 3 (7%)
Skin (62) (60) (61) (61)
Basal Cell Adenoma 1 (2%)
Keratoacanthoma 3 (5%) 1 (2%) 3 (5%) 1 (2%)
Squamous Cell Carcinoma 1 (2%)
Trichoepithelioma 1 (2%)
Subcutaneous Tissue, Fibroma 1 (2%) 1 (2%)
Subcutaneous Tissue, Fibrous Histiocytoma 1 (2%)
Subcutaneous Tissue, Sarcoma 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (62) (60) (61) (61)
Osteosarcoma 1 (2%)
Skeletal Muscle (62) (60) (60) (61)
Fibrous Histiocytoma 1 (2%)
Thymoma Malignant, Metastatic, Thymus 1 (2%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (62) (59) (61) (61)
Astrocytoma Malignant 1 (2%) 1 (2%)
Reticulosis Malignant 1 (2%)
Cranial Nerve, Schwannoma Malignant 1 (2%)
Spinal Cord (62) (59) (58) (59)
Glioma NOS 1 (2%)
____________________________________________________________________________________________________________________________________
Page 9
NTP Experiment-Test: 05214-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC TRANS-DELTA-9-TETRAHYDROCANNABINOL Date: 05/20/95
Route: GAVAGE Time: 12:11:43
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 12.5 25 50
MG/KG MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (62) (60) (61) (61)
Alveolar/Bronchiolar Adenoma 1 (2%) 1 (2%)
Fibrous Histiocytoma 1 (2%)
Osteosarcoma, Metastatic, Bone 1 (2%)
Sarcoma, Metastatic, Skin 1 (2%)
Squamous Cell Carcinoma 1 (2%)
Thymoma Malignant, Metastatic, Thymus 1 (2%)
Nose (62) (60) (61) (61)
Squamous Cell Carcinoma 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Zymbal's Gland (1) (2)
Carcinoma 1 (100%) 1 (50%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (62) (60) (61) (61)
Thymoma Malignant, Metastatic, Thymus 1 (2%)
Renal Tubule, Adenoma 1 (2%)
Urinary Bladder (61) (60) (61) (61)
____________________________________________________________________________________________________________________________________
SYSTEMIC LESIONS
Multiple Organs *(62) *(60) *(61) *(61)
Histiocytic Sarcoma 1 (2%)
Leukemia Mononuclear 14 (23%) 9 (15%) 10 (16%) 8 (13%)
Mesothelioma Malignant 2 (3%) 2 (3%) 2 (3%)
____________________________________________________________________________________________________________________________________
* Number of animals with any tissue examined microscopically
Page 10
NTP Experiment-Test: 05214-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC TRANS-DELTA-9-TETRAHYDROCANNABINOL Date: 05/20/95
Route: GAVAGE Time: 12:11:43
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 12.5 25 50
MG/KG MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
TUMOR SUMMARY
Total Animals with Primary Neoplasms (b) 61 53 52 48
Total Primary Neoplasms 145 105 90 96
Total Animals with Benign Neoplasms 60 50 49 48
Total Benign Neoplasms 118 88 70 76
Total Animals with Malignant Neoplasms 22 17 17 14
Total Malignant Neoplasms 27 17 19 20
Total Animals with Metastatic Neoplasms 1 1 1 1
Total Metastatic Neoplasm 1 2 5 1
Total Animals with Malignant Neoplasms
Uncertain Primary Site
Total Animals with Neoplasms Uncertain-
Benign or Malignant 1
Total Uncertain Neoplasms 1
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
b Primary tumors: all tumors except metastatic tumors
Page 11
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