TDMS Study 55323-04 Pathology Tables
NTP Experiment-Test: 55323-04 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC LAURIC ACID DIETHANOLAMINE CONDENSATE Date: 07/30/97 Route: SKIN APPLICATION Time: 07:31:35 2 YEAR CHRONIC Facility: Battelle Columbus Laboratory Chemical CAS #: 120-40-1 Lock Date: 07/13/95 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: 55323-04 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC LAURIC ACID DIETHANOLAMINE CONDENSATE Date: 07/30/97 Route: SKIN APPLICATION Time: 07:31:35 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0 MG/KG 100 200 MG/KG MG/KG ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially in Study 50 50 50 Early Deaths Natural Death 4 2 5 Moribund Sacrifice 9 7 15 Accidently Killed 1 Survivors Terminal Sacrifice 37 40 29 Missing 1 Animals Examined Microscopically 50 49 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Small, Duodenum (50) (49) (50) Polyp Adenomatous 1 (2%) Intestine Small, Jejunum (50) (49) (50) Liver (50) (49) (50) Hemangiosarcoma 2 (4%) 1 (2%) Hepatoblastoma 1 (2%) Hepatocellular Carcinoma 7 (14%) 10 (20%) 14 (28%) Hepatocellular Carcinoma, Multiple 3 (6%) 3 (6%) 2 (4%) Hepatocellular Adenoma 11 (22%) 18 (37%) 14 (28%) Hepatocellular Adenoma, Multiple 12 (24%) 15 (31%) 15 (30%) Histiocytic Sarcoma 2 (4%) Pheochromocytoma Malignant, Metastatic, Adrenal Medulla 1 (2%) Mesentery (7) (10) (4) Pheochromocytoma Malignant, Metastatic, Adrenal Medulla 1 (25%) Pancreas (50) (49) (50) Hepatocellular Carcinoma, Metastatic, Liver 1 (2%) Salivary Glands (50) (49) (50) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (50) (49) (50) Pheochromocytoma Malignant, Metastatic, Adrenal Medulla 1 (2%) ____________________________________________________________________________________________________________________________________ Page 2 NTP Experiment-Test: 55323-04 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC LAURIC ACID DIETHANOLAMINE CONDENSATE Date: 07/30/97 Route: SKIN APPLICATION Time: 07:31:35 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0 MG/KG 100 200 MG/KG MG/KG ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (50) (49) (50) Adenoma 1 (2%) Adrenal Medulla (50) (49) (50) Pheochromocytoma Malignant 1 (2%) Pheochromocytoma Benign 1 (2%) 2 (4%) Islets, Pancreatic (50) (49) (50) Adenoma 1 (2%) 1 (2%) Pituitary Gland (47) (49) (50) Pars Distalis, Adenoma 9 (19%) 9 (18%) 7 (14%) Pars Distalis, Adenoma, Multiple 1 (2%) Pars Intermedia, Adenoma 1 (2%) Thyroid Gland (50) (49) (50) Follicular Cell, Adenoma 4 (8%) 3 (6%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Ovary (50) (49) (50) Cystadenoma 4 (8%) 1 (2%) 2 (4%) Granulosa Cell Tumor Malignant 1 (2%) Granulosa Cell Tumor Benign 2 (4%) 1 (2%) Granulosa-Theca Tumor Malignant 1 (2%) 1 (2%) Histiocytic Sarcoma 1 (2%) Bilateral, Granulosa Cell Tumor Benign 1 (2%) Uterus (50) (49) (50) Deciduoma Benign 1 (2%) Granulosa-Theca Tumor Malignant, Metastatic, Ovary 1 (2%) Histiocytic Sarcoma 1 (2%) Polyp Stromal 2 (4%) 1 (2%) Schwannoma Malignant 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (50) (49) (50) Hemangiosarcoma 1 (2%) Lymph Node (5) (4) (7) Lumbar, Fibrous Histiocytoma 1 (20%) Lumbar, Histiocytic Sarcoma 1 (14%) Mediastinal, Fibrous Histiocytoma 1 (20%) Page 3 NTP Experiment-Test: 55323-04 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC LAURIC ACID DIETHANOLAMINE CONDENSATE Date: 07/30/97 Route: SKIN APPLICATION Time: 07:31:35 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0 MG/KG 100 200 MG/KG MG/KG ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - cont Mediastinal, Pheochromocytoma Malignant, Metastatic, Adrenal Medulla 1 (14%) Popliteal, Fibrous Histiocytoma 1 (20%) Renal, Fibrous Histiocytoma 1 (20%) Renal, Hemangiosarcoma 1 (25%) Lymph Node, Mandibular (46) (48) (48) Hemangiosarcoma 1 (2%) Histiocytic Sarcoma 1 (2%) Lymph Node, Mesenteric (49) (48) (47) Fibrous Histiocytoma 1 (2%) Histiocytic Sarcoma 1 (2%) Spleen (50) (49) (50) Fibrous Histiocytoma 1 (2%) Hemangiosarcoma 2 (4%) 1 (2%) Histiocytic Sarcoma 1 (2%) Thymus (50) (47) (50) Histiocytic Sarcoma 1 (2%) Thymoma Benign 1 (2%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (49) (49) (50) Carcinoma 1 (2%) Skin (50) (49) (50) Subcutaneous Tissue, Fibrosarcoma 2 (4%) Subcutaneous Tissue, Hemangiosarcoma 1 (2%) Subcutaneous Tissue, Skin, Site of Application, Fibrosarcoma 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Skeletal Muscle (1) (1) (1) Rhabdomyosarcoma 1 (100%) 1 (100%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (49) (50) ____________________________________________________________________________________________________________________________________ Page 4 NTP Experiment-Test: 55323-04 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC LAURIC ACID DIETHANOLAMINE CONDENSATE Date: 07/30/97 Route: SKIN APPLICATION Time: 07:31:35 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0 MG/KG 100 200 MG/KG MG/KG ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (49) (50) Alveolar/Bronchiolar Adenoma 1 (2%) 2 (4%) 1 (2%) Alveolar/Bronchiolar Carcinoma 7 (14%) 3 (6%) 3 (6%) Carcinoma, Metastatic, Harderian Gland 1 (2%) 1 (2%) Granular Cell Tumor Malignant, Metastatic, Ovary 1 (2%) Hepatocellular Carcinoma, Metastatic, Liver 3 (6%) 2 (4%) 2 (4%) Histiocytic Sarcoma 2 (4%) Pheochromocytoma Malignant, Metastatic, Adrenal Medulla 1 (2%) Mediastinum, Hemangiosarcoma 1 (2%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Harderian Gland (2) (1) (1) Adenoma 1 (50%) Carcinoma 1 (50%) 1 (100%) 1 (100%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (49) (50) Urinary Bladder (50) (49) (50) ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS Multiple Organs *(50) *(49) *(50) Histiocytic Sarcoma 2 (4%) Lymphoma Malignant 9 (18%) 5 (10%) 9 (18%) ____________________________________________________________________________________________________________________________________ * Number of animals with any tissue examined microscopically Page 5 NTP Experiment-Test: 55323-04 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC LAURIC ACID DIETHANOLAMINE CONDENSATE Date: 07/30/97 Route: SKIN APPLICATION Time: 07:31:35 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0 MG/KG 100 200 MG/KG MG/KG ____________________________________________________________________________________________________________________________________ TUMOR SUMMARY Total Animals with Primary Neoplasms (b) 44 43 45 Total Primary Neoplasms 90 82 85 Total Animals with Benign Neoplasms 34 37 35 Total Benign Neoplasms 50 53 44 Total Animals with Malignant Neoplasms 30 22 31 Total Malignant Neoplasms 40 29 41 Total Animals with Metastatic Neoplasms 5 4 3 Total Metastatic Neoplasm 6 4 7 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 6 NTP Experiment-Test: 55323-04 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC LAURIC ACID DIETHANOLAMINE CONDENSATE Date: 07/30/97 Route: SKIN APPLICATION Time: 07:31:35 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0 MG/KG 100 200 MG/KG MG/KG ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially in Study 50 50 50 Early Deaths Moribund Sacrifice 7 6 7 Natural Death 3 7 2 Survivors Terminal Sacrifice 40 37 41 Animals Examined Microscopically 50 50 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Gallbladder (47) (49) (49) Intestine Small, Duodenum (50) (50) (49) Polyp Adenomatous 1 (2%) Intestine Small, Jejunum (50) (50) (50) Epithelium, Carcinoma 1 (2%) Liver (50) (50) (50) Carcinoid Tumor Malignant, Metastatic, Stomach, Forestomach 1 (2%) Carcinoid Tumor Malignant, Metastatic, Stomach, Glandular 1 (2%) Carcinoma, Metastatic, Islets, Pancreatic 1 (2%) Carcinoma, Metastatic, Mammary Gland 1 (2%) Hemangiosarcoma 7 (14%) 2 (4%) 3 (6%) Hepatocellular Carcinoma 8 (16%) 8 (16%) 11 (22%) Hepatocellular Carcinoma, Multiple 3 (6%) 1 (2%) Hepatocellular Adenoma 13 (26%) 22 (44%) 15 (30%) Hepatocellular Adenoma, Multiple 6 (12%) 4 (8%) 10 (20%) Hepatocholangiocarcinoma 1 (2%) Pancreas (50) (50) (50) Acinus, Hepatocholangiocarcinoma, Metastatic, Liver 1 (2%) Stomach, Forestomach (50) (50) (50) Stomach, Glandular (50) (50) (50) Carcinoid Tumor Malignant 1 (2%) Serosa, Carcinoid Tumor Malignant, Metastatic, Stomach, Glandular 1 (2%) ____________________________________________________________________________________________________________________________________ Page 7 NTP Experiment-Test: 55323-04 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC LAURIC ACID DIETHANOLAMINE CONDENSATE Date: 07/30/97 Route: SKIN APPLICATION Time: 07:31:35 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0 MG/KG 100 200 MG/KG MG/KG ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (50) (50) (50) Carcinoma, Metastatic, Mammary Gland 1 (2%) Hepatocellular Carcinoma, Metastatic, Liver 1 (2%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (50) (50) (50) Adenoma 1 (2%) 4 (8%) Capsule, Adenoma 1 (2%) 3 (6%) 1 (2%) Adrenal Medulla (50) (50) (49) Pheochromocytoma Malignant 1 (2%) Pheochromocytoma Benign 1 (2%) Islets, Pancreatic (50) (50) (50) Adenoma 2 (4%) 1 (2%) Carcinoma 1 (2%) Pituitary Gland (48) (49) (50) Pars Distalis, Adenoma 1 (2%) Thyroid Gland (50) (50) (50) Follicular Cell, Adenoma 1 (2%) 4 (8%) 2 (4%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Epididymis (50) (50) (50) Prostate (50) (50) (50) Carcinoma, Metastatic, Mammary Gland 1 (2%) Seminal Vesicle (50) (50) (50) Testes (50) (50) (50) Interstitial Cell, Adenoma 1 (2%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (50) (50) (50) Hemangiosarcoma 1 (2%) Lymph Node (3) (2) (1) Mediastinal, Alveolar/Bronchiolar Carcinoma, Metastatic, Lung 1 (33%) Mediastinal, Carcinoma, Metastatic, Mammary Gland 1 (100%) Page 8 NTP Experiment-Test: 55323-04 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC LAURIC ACID DIETHANOLAMINE CONDENSATE Date: 07/30/97 Route: SKIN APPLICATION Time: 07:31:35 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0 MG/KG 100 200 MG/KG MG/KG ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - cont Lymph Node, Mandibular (46) (45) (46) Lymph Node, Mesenteric (49) (49) (50) Carcinoma, Metastatic, Mammary Gland 1 (2%) Hemangiosarcoma 1 (2%) Spleen (50) (50) (50) Hemangiosarcoma 2 (4%) 2 (4%) Thymus (45) (45) (49) Hemangioma 1 (2%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (5) (1) Carcinoma 1 (100%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM None ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (50) (50) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (50) (50) Alveolar/Bronchiolar Adenoma 5 (10%) 5 (10%) 9 (18%) Alveolar/Bronchiolar Adenoma, Multiple 1 (2%) 1 (2%) 1 (2%) Alveolar/Bronchiolar Carcinoma 6 (12%) 8 (16%) 6 (12%) Alveolar/Bronchiolar Carcinoma, Multiple 2 (4%) Carcinoma, Metastatic, Islets, Pancreatic 1 (2%) Carcinoma, Metastatic, Mammary Gland 1 (2%) Hemangiosarcoma, Metastatic, Liver 1 (2%) 1 (2%) Hepatocellular Carcinoma, Metastatic, Liver 3 (6%) 2 (4%) 4 (8%) Hepatocholangiocarcinoma, Metastatic, Liver 1 (2%) Bronchiole, Adenoma 1 (2%) Nose (50) (50) (50) ____________________________________________________________________________________________________________________________________ Page 9 NTP Experiment-Test: 55323-04 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC LAURIC ACID DIETHANOLAMINE CONDENSATE Date: 07/30/97 Route: SKIN APPLICATION Time: 07:31:35 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0 MG/KG 100 200 MG/KG MG/KG ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Harderian Gland (1) (2) (3) Adenoma 1 (100%) 2 (100%) 3 (100%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (50) (50) Carcinoma, Metastatic, Mammary Gland 1 (2%) Renal Tubule, Adenoma 1 (2%) 1 (2%) Ureter (1) Urinary Bladder (50) (50) (50) ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS Multiple Organs *(50) *(50) *(50) Lymphoma Malignant 4 (8%) 3 (6%) 2 (4%) ____________________________________________________________________________________________________________________________________ * Number of animals with any tissue examined microscopically Page 10 NTP Experiment-Test: 55323-04 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC LAURIC ACID DIETHANOLAMINE CONDENSATE Date: 07/30/97 Route: SKIN APPLICATION Time: 07:31:35 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0 MG/KG 100 200 MG/KG MG/KG ____________________________________________________________________________________________________________________________________ TUMOR SUMMARY Total Animals with Primary Neoplasms (b) 45 44 42 Total Primary Neoplasms 67 76 69 Total Animals with Benign Neoplasms 27 36 35 Total Benign Neoplasms 32 51 43 Total Animals with Malignant Neoplasms 29 23 22 Total Malignant Neoplasms 35 25 26 Total Animals with Metastatic Neoplasms 5 5 6 Total Metastatic Neoplasm 8 6 13 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 ---------- ------------------------------------------------------------