Incidence Rates of Neoplasms by Anatomic Site
NTP Experiment-Test: 91014-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC OLEIC ACID DIETHANOLAMINE CONDENSATE Date: 11/14/97 Route: SKIN APPLICATION Time: 13:31:08 Facility: Battelle Columbus Laboratory Chemical CAS #: 93-83-4 Lock Date: 01/02/96 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: 91014-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC OLEIC ACID DIETHANOLAMINE CONDENSATE Date: 11/14/97 Route: SKIN APPLICATION Time: 13:31:08 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 MG/KG 50 MG/KG 100MG/KG ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially in Study 50 50 50 Early Deaths Natural Death 24 23 31 Moribund Sacrifice 11 9 5 Survivors Terminal Sacrifice 15 18 14 Animals Examined Microscopically 50 50 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Esophagus (49) (50) (50) Lipoma 1 (2%) Intestine Small, Duodenum (50) (50) (50) Carcinoma 1 (2%) Liver (50) (50) (50) Hepatocellular Adenoma 1 (2%) Histiocytic Sarcoma 1 (2%) Pancreas (50) (50) (50) Salivary Glands (50) (50) (50) Schwannoma Malignant 1 (2%) Stomach, Forestomach (50) (50) (50) Tongue (1) Squamous Cell Papilloma 1 (100%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Blood Vessel (50) (50) (50) Heart (50) (50) (50) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (50) (50) (50) Adrenal Medulla (50) (50) (50) Pheochromocytoma Benign 2 (4%) 1 (2%) Pituitary Gland (50) (50) (50) Pars Distalis, Adenoma 26 (52%) 19 (38%) 17 (34%) Pars Distalis, Adenoma, Multiple 3 (6%) 1 (2%) 2 (4%) Thyroid Gland (50) (50) (50) Bilateral, C-Cell, Adenoma 1 (2%) C-Cell, Adenoma 3 (6%) 4 (8%) 2 (4%) Follicular Cell, Adenoma 1 (2%) Page 2 NTP Experiment-Test: 91014-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC OLEIC ACID DIETHANOLAMINE CONDENSATE Date: 11/14/97 Route: SKIN APPLICATION Time: 13:31:08 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 MG/KG 50 MG/KG 100MG/KG ____________________________________________________________________________________________________________________________________ ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM Tissue NOS (1) Sarcoma 1 (100%) ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Clitoral Gland (49) (47) (50) Adenoma 9 (18%) 3 (6%) 4 (8%) Carcinoma 1 (2%) 1 (2%) Schwannoma Malignant 1 (2%) Bilateral, Adenoma 1 (2%) Ovary (50) (50) (50) Histiocytic Sarcoma 1 (2%) Sarcoma 1 (2%) Uterus (50) (50) (50) Adenoma 1 (2%) Deciduoma Benign 1 (2%) Polyp Stromal 1 (2%) 2 (4%) 2 (4%) Vagina (1) (1) Polyp 1 (100%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (50) (50) (50) Histiocytic Sarcoma 1 (2%) Lymph Node (2) (2) (1) Lymph Node, Mandibular (49) (49) (49) Histiocytic Sarcoma 1 (2%) Lymph Node, Mesenteric (50) (50) (50) Histiocytic Sarcoma 1 (2%) Spleen (50) (50) (50) Histiocytic Sarcoma 1 (2%) Thymus (47) (46) (50) Histiocytic Sarcoma 1 (2%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (49) (49) (50) Adenoma 1 (2%) Carcinoma 1 (2%) 3 (6%) Fibroadenoma 9 (18%) 10 (20%) 6 (12%) Mixed Tumor Malignant 1 (2%) Page 3 NTP Experiment-Test: 91014-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC OLEIC ACID DIETHANOLAMINE CONDENSATE Date: 11/14/97 Route: SKIN APPLICATION Time: 13:31:08 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 MG/KG 50 MG/KG 100MG/KG ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM - cont Skin (50) (50) (50) Melanoma Malignant 1 (2%) Subcutaneous Tissue, Fibroma 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (50) (50) (50) Osteosarcoma 1 (2%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (50) (50) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (50) (50) Adenoma 1 (2%) Alveolar/Bronchiolar Adenoma 1 (2%) 1 (2%) Chordoma, Metastatic, Uncertain Primary Site 1 (2%) Histiocytic Sarcoma 1 (2%) Squamous Cell Carcinoma 1 (2%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM None ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (50) (50) Lipoma 1 (2%) Renal Tubule, Adenoma, Multiple 1 (2%) Urinary Bladder (50) (49) (49) Transitional Epithelium, Carcinoma 1 (2%) ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS Multiple Organs *(50) *(50) *(50) Histiocytic Sarcoma 1 (2%) Leukemia Mononuclear 5 (10%) 9 (18%) 8 (16%) Lymphoma Malignant 1 (2%) * Number of animals with any tissue examined microscopically Page 4 NTP Experiment-Test: 91014-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC OLEIC ACID DIETHANOLAMINE CONDENSATE Date: 11/14/97 Route: SKIN APPLICATION Time: 13:31:08 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 MG/KG 50 MG/KG 100MG/KG ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS - cont Multiple Organs *(50) *(50) *(50) ____________________________________________________________________________________________________________________________________ Page 5 NTP Experiment-Test: 91014-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC OLEIC ACID DIETHANOLAMINE CONDENSATE Date: 11/14/97 Route: SKIN APPLICATION Time: 13:31:08 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 MG/KG 50 MG/KG 100MG/KG ____________________________________________________________________________________________________________________________________ TUMOR SUMMARY Total Animals with Primary Neoplasms (b) 40 34 32 Total Primary Neoplasms 70 61 51 Total Animals with Benign Neoplasms 38 28 26 Total Benign Neoplasms 58 45 39 Total Animals with Malignant Neoplasms 12 15 12 Total Malignant Neoplasms 12 16 12 Total Animals with Metastatic Neoplasms 1 Total Metastatic Neoplasm 1 Total Animals with Malignant Neoplasms 1 Uncertain Primary Site Total Animals with Neoplasms Uncertain- Benign or Malignant Total Uncertain Neoplasms ____________________________________________________________________________________________________________________________________ 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: 91014-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC OLEIC ACID DIETHANOLAMINE CONDENSATE Date: 11/14/97 Route: SKIN APPLICATION Time: 13:31:08 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 MG/KG 50 MG/KG 100MG/KG ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially in Study 50 50 50 Early Deaths Natural Death 16 10 12 Moribund Sacrifice 26 30 24 Survivors Terminal Sacrifice 8 10 14 Animals Examined Microscopically 50 50 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Cecum (38) (41) (40) Intestine Small, Duodenum (50) (50) (50) Intestine Small, Jejunum (42) (45) (43) Carcinoma 1 (2%) Leiomyosarcoma 1 (2%) Intestine Small, Ileum (41) (45) (45) Liver (50) (50) (50) Hepatocellular Carcinoma 1 (2%) Hepatocellular Adenoma 1 (2%) Mesentery (5) (7) (3) Oral Mucosa (1) Squamous Cell Papilloma 1 (100%) Pancreas (50) (50) (50) Acinus, Adenoma 1 (2%) Salivary Glands (50) (50) (50) Carcinoma 1 (2%) Stomach, Forestomach (50) (50) (50) Squamous Cell Carcinoma 1 (2%) Squamous Cell Papilloma 1 (2%) Stomach, Glandular (50) (49) (50) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Blood Vessel (50) (50) (50) Heart (50) (49) (50) ____________________________________________________________________________________________________________________________________ Page 7 NTP Experiment-Test: 91014-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC OLEIC ACID DIETHANOLAMINE CONDENSATE Date: 11/14/97 Route: SKIN APPLICATION Time: 13:31:08 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 MG/KG 50 MG/KG 100MG/KG ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (50) (50) (50) Adrenal Medulla (50) (50) (49) Pheochromocytoma Complex 1 (2%) Pheochromocytoma Benign 8 (16%) 3 (6%) 3 (6%) Bilateral, Pheochromocytoma Benign 4 (8%) 3 (6%) 3 (6%) Islets, Pancreatic (50) (50) (50) Adenoma 1 (2%) 3 (6%) Carcinoma 2 (4%) 1 (2%) 1 (2%) Pituitary Gland (50) (50) (49) Pars Distalis, Adenoma 37 (74%) 38 (76%) 39 (80%) Pars Distalis, Adenoma, Multiple 1 (2%) 1 (2%) Thyroid Gland (50) (50) (50) Bilateral, C-Cell, Adenoma 1 (2%) C-Cell, Adenoma 2 (4%) 5 (10%) 6 (12%) C-Cell, Carcinoma 2 (4%) 1 (2%) 1 (2%) Follicular Cell, Adenoma 4 (8%) 1 (2%) Follicular Cell, Carcinoma 2 (4%) 1 (2%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Epididymis (50) (50) (50) Preputial Gland (50) (50) (50) Adenoma 1 (2%) 1 (2%) Carcinoma 1 (2%) Prostate (50) (50) (50) Seminal Vesicle (50) (50) (50) Testes (50) (50) (50) Bilateral, Interstitial Cell, Adenoma 14 (28%) 16 (32%) 21 (42%) Interstitial Cell, Adenoma 10 (20%) 14 (28%) 16 (32%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (50) (49) (50) Lymph Node (2) Lymph Node, Mandibular (49) (49) (49) Lymph Node, Mesenteric (49) (48) (50) Spleen (50) (50) (50) Thymus (45) (42) (44) ____________________________________________________________________________________________________________________________________ Page 8 NTP Experiment-Test: 91014-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC OLEIC ACID DIETHANOLAMINE CONDENSATE Date: 11/14/97 Route: SKIN APPLICATION Time: 13:31:08 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 MG/KG 50 MG/KG 100MG/KG ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (49) (49) (49) Carcinoma 1 (2%) Fibroadenoma 3 (6%) 1 (2%) Skin (50) (50) (50) Basal Cell Adenoma 1 (2%) Hemangiosarcoma 1 (2%) Histiocytic Sarcoma 1 (2%) Keratoacanthoma 1 (2%) Subcutaneous Tissue, Fibroma 1 (2%) 1 (2%) Subcutaneous Tissue, Fibrosarcoma 1 (2%) 1 (2%) Subcutaneous Tissue, Lipoma 1 (2%) Subcutaneous Tissue, Skin, Site of Application, Fibroma 1 (2%) Subcutaneous Tissue, Skin, Site of Application, Fibrosarcoma 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (50) (49) (50) Vertebra, Chordoma 1 (2%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (50) (50) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (50) (50) Alveolar/Bronchiolar Adenoma 1 (2%) Alveolar/Bronchiolar Carcinoma 1 (2%) Hemangiosarcoma, Metastatic, Skin 1 (2%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Zymbal's Gland (1) Carcinoma 1 (100%) ____________________________________________________________________________________________________________________________________ Page 9 NTP Experiment-Test: 91014-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC OLEIC ACID DIETHANOLAMINE CONDENSATE Date: 11/14/97 Route: SKIN APPLICATION Time: 13:31:08 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 MG/KG 50 MG/KG 100MG/KG ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (50) (50) Renal Tubule, Adenoma 3 (6%) 4 (8%) 1 (2%) Renal Tubule, Carcinoma 1 (2%) Urinary Bladder (49) (50) (50) Papilloma 1 (2%) ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS Multiple Organs *(50) *(50) *(50) Histiocytic Sarcoma 1 (2%) Leukemia Granulocytic 1 (2%) Leukemia Mononuclear 14 (28%) 13 (26%) 13 (26%) Lymphoma Malignant 1 (2%) 1 (2%) Mesothelioma Malignant 2 (4%) 1 (2%) 3 (6%) ____________________________________________________________________________________________________________________________________ * Number of animals with any tissue examined microscopically Page 10 NTP Experiment-Test: 91014-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC OLEIC ACID DIETHANOLAMINE CONDENSATE Date: 11/14/97 Route: SKIN APPLICATION Time: 13:31:08 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 MG/KG 50 MG/KG 100MG/KG ____________________________________________________________________________________________________________________________________ TUMOR SUMMARY Total Animals with Primary Neoplasms (b) 49 48 50 Total Primary Neoplasms 117 114 127 Total Animals with Benign Neoplasms 47 47 49 Total Benign Neoplasms 90 91 99 Total Animals with Malignant Neoplasms 21 18 22 Total Malignant Neoplasms 27 23 28 Total Animals with Metastatic Neoplasms 1 Total Metastatic Neoplasm 1 Total Animals with Malignant Neoplasms Uncertain Primary Site Total Animals with Neoplasms Uncertain- Benign or Malignant Total Uncertain Neoplasms ____________________________________________________________________________________________________________________________________ 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 ---------- 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