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