TDMS Study 55312-03 Pathology Tables
NTP Experiment-Test: 55312-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC COCONUT OIL ACID DIETHANOLAMINE CONDENSATE Date: 01/28/99 Route: SKIN APPLICATION Time: 08:08:18 2 YEAR CHRONIC RATS Facility: Battelle Columbus Laboratory Chemical CAS #: 68603-42-9 Lock Date: 09/06/95 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: 55312-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC COCONUT OIL ACID DIETHANOLAMINE CONDENSATE Date: 01/28/99 Route: SKIN APPLICATION Time: 08:08:18 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 MG/KG 50 MG/KG 100 MG/KG ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially in Study 50 50 50 Early Deaths Natural Death 15 11 18 Moribund Sacrifice 7 15 10 Survivors Terminal Sacrifice 28 24 21 Moribund Sacrifice 1 Animals Examined Microscopically 50 50 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Small, Duodenum (50) (50) (50) Liver (50) (50) (50) Hepatocellular Adenoma 1 (2%) Histiocytic Sarcoma 1 (2%) Mesentery (4) (5) (2) Oral Mucosa (1) (1) (3) Gingival, Squamous Cell Carcinoma 1 (33%) Pancreas (50) (50) (50) Salivary Glands (50) (50) (49) Stomach, Forestomach (50) (50) (50) Squamous Cell Papilloma 1 (2%) Squamous Cell Papilloma, Multiple 1 (2%) Stomach, Glandular (50) (50) (50) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (50) (50) (50) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (50) (50) (50) Adenoma 2 (4%) Adrenal Medulla (50) (50) (50) Histiocytic Sarcoma 1 (2%) Pheochromocytoma Benign 4 (8%) Islets, Pancreatic (50) (50) (50) Adenoma 1 (2%) 2 (4%) Parathyroid Gland (42) (46) (45) Adenoma 1 (2%) Pituitary Gland (50) (49) (50) NTP Experiment-Test: 55312-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC COCONUT OIL ACID DIETHANOLAMINE CONDENSATE Date: 01/28/99 Route: SKIN APPLICATION Time: 08:08:18 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 MG/KG 50 MG/KG 100 MG/KG ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM - cont Pars Distalis, Adenoma 27 (54%) 26 (53%) 24 (48%) Pars Intermedia, Adenoma 1 (2%) Thyroid Gland (50) (50) (50) C-Cell, Adenoma 4 (8%) 3 (6%) 6 (12%) C-Cell, Carcinoma 1 (2%) 2 (4%) 2 (4%) Follicular Cell, Adenoma 2 (4%) Follicular Cell, Carcinoma 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Clitoral Gland (49) (50) (50) Adenoma 7 (14%) 5 (10%) 4 (8%) Carcinoma 1 (2%) 6 (12%) 2 (4%) Bilateral, Adenoma 1 (2%) Bilateral, Carcinoma 1 (2%) 2 (4%) 2 (4%) Ovary (50) (50) (50) Granulosa-Theca Tumor Malignant 1 (2%) Granulosa-Theca Tumor Benign 1 (2%) Histiocytic Sarcoma 1 (2%) Uterus (50) (50) (50) Deciduoma Benign 1 (2%) Leiomyosarcoma 1 (2%) Polyp Stromal 6 (12%) 6 (12%) 5 (10%) Sarcoma Stromal 1 (2%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (50) (50) (50) Lymph Node (41) (36) (36) Mediastinal, Histiocytic Sarcoma 1 (2%) Lymph Node, Mandibular (50) (48) (47) Lymph Node, Mesenteric (50) (50) (50) Histiocytic Sarcoma 1 (2%) Spleen (50) (50) (50) Thymus (47) (50) (49) Histiocytic Sarcoma 1 (2%) Thymoma Benign 1 (2%) ____________________________________________________________________________________________________________________________________ NTP Experiment-Test: 55312-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC COCONUT OIL ACID DIETHANOLAMINE CONDENSATE Date: 01/28/99 Route: SKIN APPLICATION Time: 08:08:18 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 MG/KG 50 MG/KG 100 MG/KG ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (49) (50) (50) Adenoma 1 (2%) Carcinoma 2 (4%) 1 (2%) 2 (4%) Carcinoma, Multiple 1 (2%) Fibroadenoma 17 (35%) 14 (28%) 3 (6%) Fibroadenoma, Multiple 1 (2%) 2 (4%) Skin (50) (50) (50) Squamous Cell Papilloma, Multiple 1 (2%) Sebaceous Gland, Skin, Site of Application, Adenoma 1 (2%) Subcutaneous Tissue, Histiocytic Sarcoma 1 (2%) Subcutaneous Tissue, Pinna, Melanoma Malignant 1 (2%) Subcutaneous Tissue, Skin, Site of Application, Fibrosarcoma 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (50) (50) (50) Femur, Osteosarcoma 1 (2%) Skeletal Muscle (3) (1) Histiocytic Sarcoma 1 (33%) Osteosarcoma, Metastatic, Bone 1 (33%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (50) (50) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (50) (50) Granulosa-Theca Tumor Malignant, Metastatic, Ovary 1 (2%) Histiocytic Sarcoma 1 (2%) Osteosarcoma, Metastatic, Bone 1 (2%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM None ____________________________________________________________________________________________________________________________________ NTP Experiment-Test: 55312-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC COCONUT OIL ACID DIETHANOLAMINE CONDENSATE Date: 01/28/99 Route: SKIN APPLICATION Time: 08:08:18 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 MG/KG 50 MG/KG 100 MG/KG ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (50) (50) Renal Tubule, Carcinoma 2 (4%) Urinary Bladder (50) (50) (50) Papilloma 1 (2%) Transitional Epithelium, Papilloma 1 (2%) ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS Multiple Organs *(50) *(50) *(50) Histiocytic Sarcoma 1 (2%) Leukemia Mononuclear 10 (20%) 9 (18%) 4 (8%) Lymphoma Malignant 2 (4%) ____________________________________________________________________________________________________________________________________ * Number of animals with any tissue examined microscopically Page 5 NTP Experiment-Test: 55312-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC COCONUT OIL ACID DIETHANOLAMINE CONDENSATE Date: 01/28/99 Route: SKIN APPLICATION Time: 08:08:18 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 MG/KG 50 MG/KG 100 MG/KG ____________________________________________________________________________________________________________________________________ TUMOR SUMMARY Total Animals with Primary Neoplasms (b) 48 43 37 Total Primary Neoplasms 89 93 65 Total Animals with Benign Neoplasms 43 39 34 Total Benign Neoplasms 69 66 50 Total Animals with Malignant Neoplasms 19 20 15 Total Malignant Neoplasms 20 27 15 Total Animals with Metastatic Neoplasms 2 Total Metastatic Neoplasm 3 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 NTP Experiment-Test: 55312-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC COCONUT OIL ACID DIETHANOLAMINE CONDENSATE Date: 01/28/99 Route: SKIN APPLICATION Time: 08:08:18 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 MG/KG 50 MG/KG 100 MG/KG ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially in Study 50 50 50 Early Deaths Moribund Sacrifice 28 27 25 Natural Death 13 11 14 Accidently Killed 1 Survivors Terminal Sacrifice 8 12 11 Animals Examined Microscopically 50 50 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Esophagus (50) (50) (50) Thymoma Malignant, Metastatic, Thymus 1 (2%) Intestine Large, Colon (50) (50) (50) Polyp Adenomatous 1 (2%) 1 (2%) Intestine Small, Ileum (50) (50) (50) Liver (50) (50) (50) Mesentery (8) (7) (6) Fat, Fibrosarcoma 1 (14%) Oral Mucosa (1) (2) (2) Gingival, Squamous Cell Carcinoma 1 (50%) Pharyngeal, Squamous Cell Papilloma 1 (100%) Pancreas (50) (50) (50) Acinus, Adenoma 1 (2%) Salivary Glands (50) (50) (50) Stomach, Forestomach (50) (50) (50) Squamous Cell Papilloma 3 (6%) 1 (2%) Squamous Cell Papilloma, Multiple 1 (2%) Stomach, Glandular (50) (50) (50) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (50) (50) (50) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (50) (50) (50) Adenoma 1 (2%) Adrenal Medulla (50) (50) (50) Ganglioneuroma 1 (2%) Pheochromocytoma Malignant 1 (2%) NTP Experiment-Test: 55312-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC COCONUT OIL ACID DIETHANOLAMINE CONDENSATE Date: 01/28/99 Route: SKIN APPLICATION Time: 08:08:18 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 MG/KG 50 MG/KG 100 MG/KG ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM - cont Pheochromocytoma Benign 6 (12%) 4 (8%) 5 (10%) Bilateral, Pheochromocytoma Benign 1 (2%) 1 (2%) Islets, Pancreatic (50) (50) (50) Adenoma 3 (6%) 4 (8%) 3 (6%) Pituitary Gland (50) (50) (49) Sarcoma, Metastatic, Brain 1 (2%) Pars Distalis, Adenoma 37 (74%) 39 (78%) 36 (73%) Thyroid Gland (50) (50) (50) C-Cell, Adenoma 3 (6%) 4 (8%) 4 (8%) C-Cell, Carcinoma 1 (2%) Follicular Cell, Adenoma 3 (6%) 1 (2%) Follicular Cell, Carcinoma 2 (4%) 1 (2%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM Peritoneum (1) ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Epididymis (50) (50) (50) Preputial Gland (50) (50) (50) Adenoma 2 (4%) 1 (2%) Carcinoma 1 (2%) 2 (4%) Bilateral, Adenoma 1 (2%) Prostate (50) (50) (50) Carcinoma 2 (4%) Seminal Vesicle (50) (50) (50) Testes (50) (50) (50) Bilateral, Interstitial Cell, Adenoma 11 (22%) 9 (18%) 12 (24%) Interstitial Cell, Adenoma 12 (24%) 11 (22%) 7 (14%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (50) (50) (50) Lymph Node (35) (30) (37) Mediastinal, Fibrosarcoma, Metastatic, Skin 1 (3%) Lymph Node, Mandibular (50) (50) (50) Lymph Node, Mesenteric (49) (50) (50) Spleen (50) (50) (50) Hemangiosarcoma 1 (2%) Thymus (47) (45) (48) Thymoma Malignant 1 (2%) ____________________________________________________________________________________________________________________________________ NTP Experiment-Test: 55312-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC COCONUT OIL ACID DIETHANOLAMINE CONDENSATE Date: 01/28/99 Route: SKIN APPLICATION Time: 08:08:18 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 MG/KG 50 MG/KG 100 MG/KG ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (48) (49) (50) Adenoma 1 (2%) Carcinoma 1 (2%) 1 (2%) Fibroadenoma 2 (4%) 1 (2%) 1 (2%) Skin (50) (50) (50) Basal Cell Carcinoma 1 (2%) Keratoacanthoma 2 (4%) 4 (8%) Squamous Cell Papilloma 1 (2%) 1 (2%) Trichoepithelioma 1 (2%) Pinna, Squamous Cell Papilloma 1 (2%) Sebaceous Gland, Carcinoma 1 (2%) Sebaceous Gland, Skin, Site of Application, Adenoma 1 (2%) Skin, Site of Application, Basal Cell Adenoma 1 (2%) Skin, Site of Application, Basal Cell Carcinoma 1 (2%) Skin, Site of Application, Keratoacanthoma 1 (2%) 2 (4%) Subcutaneous Tissue, Fibroma 3 (6%) 3 (6%) 1 (2%) Subcutaneous Tissue, Fibrosarcoma 2 (4%) 1 (2%) Subcutaneous Tissue, Skin, Site of Application, Fibrosarcoma 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (50) (50) (50) Osteosarcoma 1 (2%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (50) (50) Cranial Nerve, Schwannoma Malignant 1 (2%) Meninges, Sarcoma 1 (2%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (50) (50) Thymoma Malignant, Metastatic, Thymus 1 (2%) Nose (50) (50) (50) Squamous Cell Carcinoma 1 (2%) ____________________________________________________________________________________________________________________________________ NTP Experiment-Test: 55312-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC COCONUT OIL ACID DIETHANOLAMINE CONDENSATE Date: 01/28/99 Route: SKIN APPLICATION Time: 08:08:18 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 MG/KG 50 MG/KG 100 MG/KG ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Zymbal's Gland (1) (2) Carcinoma 1 (100%) 2 (100%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (50) (50) Lipoma 1 (2%) Thymoma Malignant, Metastatic, Thymus 1 (2%) Renal Tubule, Adenoma 1 (2%) 4 (8%) Renal Tubule, Adenoma, Multiple 1 (2%) Renal Tubule, Carcinoma 1 (2%) Urinary Bladder (50) (50) (50) ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS Multiple Organs *(50) *(50) *(50) Leukemia Granulocytic 1 (2%) Leukemia Mononuclear 16 (32%) 10 (20%) 12 (24%) Mesothelioma Malignant 2 (4%) 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ * Number of animals with any tissue examined microscopically Page 10 NTP Experiment-Test: 55312-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC COCONUT OIL ACID DIETHANOLAMINE CONDENSATE Date: 01/28/99 Route: SKIN APPLICATION Time: 08:08:18 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 MG/KG 50 MG/KG 100 MG/KG ____________________________________________________________________________________________________________________________________ TUMOR SUMMARY Total Animals with Primary Neoplasms (b) 49 49 48 Total Primary Neoplasms 117 124 98 Total Animals with Benign Neoplasms 48 49 46 Total Benign Neoplasms 90 100 75 Total Animals with Malignant Neoplasms 25 20 21 Total Malignant Neoplasms 27 24 23 Total Animals with Metastatic Neoplasms 1 1 1 Total Metastatic Neoplasm 1 1 3 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 ------------------------------------------------------------ ---------- END OF REPORT ---------- 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