TDMS Study 05214-02 Pathology Tables
INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)
TRANS-DELTA-9-TETRAHYDROCANNABINOL
NTP Experiment-Test: 05214-02 Report: PEIRPT05
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 NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC TRANS-DELTA-9-TETRAHYDROCANNABINOL Date: 05/20/95
Route: GAVAGE Time: 12:55:03
____________________________________________________________________________________________________________________________________
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
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ALIMENTARY SYSTEM
Esophagus (60) (60) (60) (59)
Adenocarcinoma 1 (2%)
Gallbladder (53) (59) (54) (54)
Intestine Large, Cecum (57) (60) (58) (57)
Intestine Small, Jejunum (57) (60) (57) (55)
Adenoma 1 (2%)
Intestine Small, Ileum (57) (60) (57) (55)
Liver (60) (60) (59) (60)
Hepatocellular Carcinoma 6 (10%) 5 (8%) 4 (7%) 1 (2%)
Hepatocellular Adenoma 13 (22%) 8 (13%) 7 (12%) 3 (5%)
Hepatocellular Adenoma, Multiple 4 (7%) 1 (2%)
Histiocytic Sarcoma 1 (2%)
Sarcoma, Metastatic, Skin 1 (2%)
Mesentery (11) (1) (1) (3)
Fibrosarcoma, Metastatic, Skin 1 (9%)
Pancreas (59) (60) (59) (57)
Salivary Glands (60) (60) (60) (60)
Stomach, Forestomach (58) (60) (58) (57)
Squamous Cell Papilloma 3 (5%) 2 (4%)
Stomach, Glandular (58) (60) (58) (57)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (60) (60) (60) (60)
____________________________________________________________________________________________________________________________________
Page 2
NTP Experiment-Test: 05214-02 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: 12:55:03
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 125 250 500
MG/KG MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (59) (60) (60) (60)
Granulosa Cell Tumor Malignant, Metastatic,
Ovary 1 (2%)
Adrenal Medulla (59) (60) (60) (60)
Pheochromocytoma Benign 1 (2%) 1 (2%) 1 (2%) 1 (2%)
Pituitary Gland (55) (58) (58) (57)
Pars Distalis, Adenoma 9 (16%) 5 (9%) 2 (3%) 4 (7%)
Pars Distalis, Carcinoma 1 (2%)
Pars Intermedia, Adenoma 1 (2%)
Thyroid Gland (60) (60) (60) (60)
Follicular Cell, Adenoma 4 (7%) 9 (15%) 3 (5%) 1 (2%)
Follicular Cell, Carcinoma 1 (2%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
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GENITAL SYSTEM
Clitoral Gland (57) (59) (56) (54)
Ovary (59) (59) (60) (59)
Cystadenoma 1 (2%) 3 (5%) 2 (3%) 1 (2%)
Granulosa Cell Tumor Malignant 1 (2%)
Granulosa Cell Tumor Benign 1 (2%)
Hemangioma 1 (2%)
Hemangiosarcoma 1 (2%)
Uterus (60) (60) (60) (60)
Hemangiosarcoma 1 (2%)
Histiocytic Sarcoma 1 (2%) 1 (2%)
Sarcoma Stromal 1 (2%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (59) (60) (60) (60)
Hemangiosarcoma 1 (2%)
Lymph Node (6) (3) (1) (2)
Pancreatic, Fibrosarcoma, Metastatic, Skin 1 (17%)
Lymph Node, Mandibular (56) (59) (59) (57)
Lymph Node, Mesenteric (57) (60) (57) (53)
Spleen (59) (60) (60) (59)
Thymus (59) (58) (56) (58)
Sarcoma 1 (2%)
____________________________________________________________________________________________________________________________________
Page 3
NTP Experiment-Test: 05214-02 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: 12:55:03
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 125 250 500
MG/KG MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (59) (59) (60) (59)
Adenocarcinoma 1 (2%)
Skin (60) (60) (60) (60)
Subcutaneous Tissue, Fibrosarcoma 1 (2%) 1 (2%) 1 (2%)
Subcutaneous Tissue, Sarcoma 1 (2%) 1 (2%) 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (60) (60) (60) (60)
Osteosarcoma 1 (2%)
Skeletal Muscle (60) (60) (60) (60)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (60) (60) (58) (60)
Ependymoma NOS 1 (2%)
Peripheral Nerve (60) (60) (60) (59)
Spinal Cord (60) (60) (60) (59)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (59) (60) (60) (60)
Alveolar/Bronchiolar Adenoma 1 (2%) 2 (3%) 2 (3%)
Alveolar/Bronchiolar Adenoma, Multiple 1 (2%) 1 (2%)
Alveolar/Bronchiolar Carcinoma 2 (3%)
Fibrosarcoma, Metastatic, Skin 1 (2%)
Hepatocellular Carcinoma, Metastatic, Liver 2 (3%)
Sarcoma, Metastatic, Skin 1 (2%)
Nose (59) (60) (60) (60)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Harderian Gland (3) (1) (1) (1)
Adenoma 3 (100%) 1 (100%) 1 (100%) 1 (100%)
____________________________________________________________________________________________________________________________________
Page 4
NTP Experiment-Test: 05214-02 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: 12:55:03
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 125 250 500
MG/KG MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (60) (60) (60) (60)
Histiocytic Sarcoma 1 (2%)
Urinary Bladder (59) (60) (60) (59)
____________________________________________________________________________________________________________________________________
SYSTEMIC LESIONS
Multiple Organs *(60) *(60) *(60) *(60)
Histiocytic Sarcoma 1 (2%) 1 (2%)
Lymphoma Malignant Lymphocytic 3 (5%) 1 (2%) 3 (5%) 2 (3%)
Lymphoma Malignant Mixed 7 (12%) 5 (8%) 1 (2%) 3 (5%)
Lymphoma Malignant Undifferentiated Cell 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
* Number of animals with any tissue examined microscopically
Page 5
NTP Experiment-Test: 05214-02 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: 12:55:03
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 125 250 500
MG/KG MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
TUMOR SUMMARY
Total Animals with Primary Neoplasms (b) 46 31 26 16
Total Primary Neoplasms 67 50 32 23
Total Animals with Benign Neoplasms 30 22 18 11
Total Benign Neoplasms 40 31 20 15
Total Animals with Malignant Neoplasms 23 14 12 6
Total Malignant Neoplasms 27 18 12 8
Total Animals with Metastatic Neoplasms 3 1 1 1
Total Metastatic Neoplasm 4 1 1 2
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: 05214-02 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: 12:55:03
____________________________________________________________________________________________________________________________________
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
Intestine Large, Colon (60) (57) (56) (54)
Intestine Large, Rectum (60) (57) (56) (54)
Anus, Squamous Cell Papilloma 1 (2%)
Intestine Large, Cecum (60) (57) (56) (55)
Intestine Small, Duodenum (60) (57) (54) (54)
Adenoma 1 (2%)
Intestine Small, Jejunum (60) (57) (53) (53)
Carcinoma 1 (2%)
Intestine Small, Ileum (60) (57) (54) (54)
Sarcoma 1 (2%)
Liver (62) (60) (61) (57)
Hemangioma 1 (2%)
Hemangiosarcoma 1 (2%)
Hepatoblastoma 2 (3%)
Hepatocellular Carcinoma 9 (15%) 3 (5%) 5 (8%) 1 (2%)
Hepatocellular Carcinoma, Multiple 1 (2%)
Hepatocellular Adenoma 16 (26%) 11 (18%) 5 (8%) 2 (4%)
Hepatocellular Adenoma, Multiple 9 (15%) 1 (2%)
Histiocytic Sarcoma 1 (2%)
Sarcoma, Metastatic, Intestine Small, Ileum 1 (2%)
Mesentery (7) (1) (1) (2)
Sarcoma, Metastatic, Intestine Small, Ileum 1 (50%)
Pancreas (62) (59) (61) (57)
Sarcoma, Metastatic, Intestine Small, Ileum 1 (2%)
Stomach, Forestomach (62) (58) (58) (56)
Mast Cell Tumor NOS 1 (2%)
Squamous Cell Papilloma 3 (5%) 2 (3%) 2 (4%)
Stomach, Glandular (62) (58) (57) (56)
Page 7
NTP Experiment-Test: 05214-02 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: 12:55:03
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 125 250 500
MG/KG MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - cont
Adenoma 1 (2%)
Carcinoma 1 (2%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (62) (60) (61) (60)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (62) (59) (61) (59)
Adenoma 1 (2%)
Capsule, Adenoma 1 (2%)
Capsule, Sarcoma, Metastatic, Intestine
Small, Ileum 1 (2%)
Adrenal Medulla (61) (59) (61) (58)
Pheochromocytoma Benign 1 (2%) 1 (2%) 1 (2%)
Pituitary Gland (59) (57) (59) (53)
Pars Distalis, Adenoma 1 (2%)
Pars Intermedia, Adenoma 1 (2%)
Thyroid Gland (62) (60) (61) (57)
Follicular Cell, Adenoma 6 (10%) 3 (5%) 1 (2%)
Follicular Cell, Carcinoma 1 (2%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Epididymis (80) (60) (70) (69)
Prostate (62) (60) (62) (60)
Seminal Vesicle (62) (60) (62) (57)
Testes (80) (60) (70) (69)
Interstitial Cell, Adenoma 1 (1%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (62) (60) (60) (58)
Histiocytic Sarcoma 1 (2%)
Lymph Node (3) (2) (2)
Pancreatic, Sarcoma, Metastatic, Intestine
Small, Ileum 1 (50%)
Page 8
NTP Experiment-Test: 05214-02 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: 12:55:03
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 125 250 500
MG/KG MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - cont
Lymph Node, Mandibular (54) (50) (54) (53)
Lymph Node, Mesenteric (59) (55) (57) (54)
Hepatocellular Carcinoma, Metastatic, Liver 1 (2%)
Spleen (62) (59) (61) (59)
Hemangioma 1 (2%)
Hemangiosarcoma 1 (2%)
Histiocytic Sarcoma 1 (2%)
Thymus (58) (50) (55) (52)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Skin (62) (60) (61) (61)
Subcutaneous Tissue, Histiocytic Sarcoma 1 (2%)
Subcutaneous Tissue, Sarcoma 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (62) (60) (60) (60)
Osteosarcoma 1 (2%)
Skeletal Muscle (62) (60) (61) (60)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Peripheral Nerve (60) (60) (61) (60)
Spinal Cord (62) (60) (61) (59)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (62) (60) (61) (59)
Alveolar/Bronchiolar Adenoma 10 (16%) 10 (17%) 7 (11%) 7 (12%)
Alveolar/Bronchiolar Adenoma, Multiple 1 (2%) 1 (2%)
Alveolar/Bronchiolar Carcinoma 4 (6%) 3 (5%) 1 (2%) 1 (2%)
Hepatoblastoma, Metastatic, Liver 1 (2%)
Hepatocellular Carcinoma, Metastatic, Liver 4 (6%) 1 (2%)
Nose (62) (59) (61) (58)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Harderian Gland (2) (4) (5) (2)
Adenoma 2 (100%) 3 (75%) 5 (100%)
____________________________________________________________________________________________________________________________________
Page 9
NTP Experiment-Test: 05214-02 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: 12:55:03
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 125 250 500
MG/KG MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (62) (60) (61) (60)
Renal Tubule, Adenoma 1 (2%) 1 (2%)
Renal Tubule, Adenoma, Multiple 1 (2%)
Urinary Bladder (62) (60) (62) (58)
____________________________________________________________________________________________________________________________________
SYSTEMIC LESIONS
Multiple Organs *(80) *(60) *(70) *(70)
Histiocytic Sarcoma 2 (3%)
Lymphoma Malignant 1 (1%)
Lymphoma Malignant Lymphocytic 2 (3%)
Lymphoma Malignant Mixed 4 (5%) 1 (2%) 3 (4%) 2 (3%)
Lymphoma Malignant Undifferentiated Cell 1 (1%)
____________________________________________________________________________________________________________________________________
* Number of animals with any tissue examined microscopically
Page 10
NTP Experiment-Test: 05214-02 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: 12:55:03
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 125 250 500
MG/KG MG/KG MG/KG MG/KG
____________________________________________________________________________________________________________________________________
TUMOR SUMMARY
Total Animals with Primary Neoplasms (b) 45 33 27 18
Total Primary Neoplasms 74 45 39 20
Total Animals with Benign Neoplasms 36 29 20 14
Total Benign Neoplasms 47 37 25 14
Total Animals with Malignant Neoplasms 25 7 12 5
Total Malignant Neoplasms 27 7 14 6
Total Animals with Metastatic Neoplasms 5 1 1
Total Metastatic Neoplasm 6 1 5
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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