TDMS Study 05130-02 Pathology Tables
INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) C. I. DIRECT BLUE 218 NTP Experiment-Test: 05130-02 Report: PEIRPT05 Study Type: CHRONIC Date: 09/16/94 Route: DOSED FEED Time: 23:49:54 Facility: Microbiological Associates Chemical CAS #: 10401-500 Lock Date: 10/29/91 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: 05130-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC C. I. DIRECT BLUE 218 Date: 09/16/94 Route: DOSED FEED Time: 23:49:54 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE CONTROL 1000 PPM 3000 PPM 10000PPM FEMALE LOW FEM MID FEM HIGH FEM ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially in Study 60 60 60 60 Scheduled Sacrifice 10 10 10 10 Early Deaths Moribund Sacrifice 5 8 1 3 Natural Death 4 2 2 5 Moribund 3 2 Accidently Killed 1 Survivors Terminal Sacrifice 37 40 46 38 Missing 1 1 1 Animals Examined Microscopically 49 50 49 49 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Gallbladder (47) (45) (46) (42) Intestine Large, Cecum (47) (50) (48) (45) Intestine Small, Duodenum (46) (50) (48) (46) Hepatocholangiocarcinoma, Metastatic, Liver 1 (2%) Intestine Small, Jejunum (47) (49) (48) (45) Carcinoma 1 (2%) Intestine Small, Ileum (48) (50) (48) (45) Carcinoma 1 (2%) Liver (49) (50) (49) (49) Hemangioma 1 (2%) Hemangiosarcoma 1 (2%) 3 (6%) 1 (2%) Hemangiosarcoma, Metastatic, Skin 1 (2%) Hepatoblastoma 1 (2%) Hepatocellular Carcinoma 5 (10%) 5 (10%) 6 (12%) 12 (24%) Hepatocellular Adenoma 6 (12%) 8 (16%) 9 (18%) 6 (12%) Hepatocellular Adenoma, Multiple 1 (2%) 4 (8%) 8 (16%) 35 (71%) Hepatocholangiocarcinoma 1 (2%) Histiocytic Sarcoma 1 (2%) Osteosarcoma, Metastatic, Bone 1 (2%) Osteosarcoma, Metastatic, Nose 1 (2%) Sarcoma Stromal, Metastatic, Uterus 1 (2%) Mesentery (6) (5) (3) (5) Hepatocholangiocarcinoma, Metastatic, Liver 1 (20%) Histiocytic Sarcoma 1 (20%) Pancreas (49) (50) (48) (49) Hepatocholangiocarcinoma, Metastatic, Liver 1 (2%) Salivary Glands (49) (50) (49) (48) Stomach, Forestomach (49) (50) (48) (49) Page 2 NTP Experiment-Test: 05130-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC C. 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DIRECT BLUE 218 Date: 09/16/94 Route: DOSED FEED Time: 23:49:54 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE CONTROL 1000 PPM 3000 PPM 10000PPM FEMALE LOW FEM MID FEM HIGH FEM ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - cont Hepatocholangiocarcinoma, Metastatic, Liver 1 (2%) Squamous Cell Papilloma 1 (2%) Stomach, Glandular (49) (50) (48) (49) Hepatocholangiocarcinoma, Metastatic, Liver 1 (2%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (49) (50) (49) (49) Histiocytic Sarcoma 1 (2%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (49) (49) (48) (48) Adenoma 1 (2%) Adrenal Medulla (49) (49) (48) (47) Pheochromocytoma Benign 1 (2%) 2 (4%) Pituitary Gland (48) (50) (49) (45) Pars Distalis, Adenoma 2 (4%) 6 (12%) 2 (4%) Thyroid Gland (49) (50) (49) (49) Follicular Cell, Adenoma 1 (2%) 1 (2%) Follicular Cell, Carcinoma 1 (2%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM Tissue NOS (1) (2) (1) Carcinoma, Metastatic, Thyroid Gland 1 (50%) Sarcoma, Metastatic, Skeletal Muscle 1 (100%) ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Ovary (47) (50) (48) (49) Choriocarcinoma 1 (2%) Cystadenoma 2 (4%) 1 (2%) 1 (2%) Granulosa Cell Tumor Benign 1 (2%) 2 (4%) Hemangioma 1 (2%) 1 (2%) Teratoma Benign 1 (2%) 1 (2%) 1 (2%) Thecoma Benign 1 (2%) Uterus (49) (50) (49) (49) Deciduoma Benign 1 (2%) Hemangioma 1 (2%) Hemangiosarcoma 1 (2%) Hemangiosarcoma, Metastatic, Bone Marrow 1 (2%) Histiocytic Sarcoma 1 (2%) Page 3 NTP Experiment-Test: 05130-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC C. 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DIRECT BLUE 218 Date: 09/16/94 Route: DOSED FEED Time: 23:49:54 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE CONTROL 1000 PPM 3000 PPM 10000PPM FEMALE LOW FEM MID FEM HIGH FEM ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM - cont Leiomyoma 1 (2%) 1 (2%) Polyp Stromal 1 (2%) 1 (2%) Sarcoma Stromal 1 (2%) 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (49) (50) (49) (49) Vertebral, Hemangiosarcoma 1 (2%) Lymph Node (9) (10) (8) (7) Bronchial, Hepatocellular Carcinoma, Metastatic, Liver 1 (10%) Bronchial, Osteosarcoma, Metastatic, Bone 1 (10%) Iliac, Sarcoma Stromal, Metastatic, Uterus 1 (11%) Lumbar, Hepatocholangiocarcinoma, Metastatic, Liver 1 (10%) Mediastinal, Hepatocholangiocarcinoma, Metastatic, Liver 1 (10%) Renal, Hepatocholangiocarcinoma, Metastatic, Liver 1 (10%) Lymph Node, Mandibular (49) (48) (48) (47) Lymph Node, Mesenteric (46) (48) (47) (46) Hepatocholangiocarcinoma, Metastatic, Liver 1 (2%) Spleen (48) (50) (49) (49) Hemangiosarcoma 1 (2%) Thymus (46) (48) (48) (46) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (49) (49) (49) (48) Adenoma 1 (2%) Skin (49) (50) (49) (49) Squamous Cell Carcinoma 1 (2%) Subcutaneous Tissue, Hemangiosarcoma 2 (4%) Subcutaneous Tissue, Sarcoma 1 (2%) Subcutaneous Tissue, Schwannoma Malignant 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (49) (50) (49) (49) Dorsal, Osteosarcoma 1 (2%) Vertebra, Hemangiosarcoma, Extension 1 (2%) Skeletal Muscle (3) (1) Back, Hemangiosarcoma, Extension 1 (33%) Back, Sarcoma 1 (100%) Page 4 NTP Experiment-Test: 05130-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC C. 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DIRECT BLUE 218 Date: 09/16/94 Route: DOSED FEED Time: 23:49:54 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE CONTROL 1000 PPM 3000 PPM 10000PPM FEMALE LOW FEM MID FEM HIGH FEM ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM - cont Diaphragm, Hepatocholangiocarcinoma, Metastatic, Liver 1 (33%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM None ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (49) (50) (49) (49) Alveolar/Bronchiolar Adenoma 5 (10%) 5 (10%) 4 (8%) 1 (2%) Alveolar/Bronchiolar Adenoma, Multiple 2 (4%) Hepatocellular Carcinoma, Metastatic, Liver 1 (2%) 1 (2%) 2 (4%) 1 (2%) Hepatocholangiocarcinoma, Metastatic, Liver 1 (2%) Histiocytic Sarcoma 1 (2%) Osteosarcoma, Metastatic, Bone 1 (2%) Osteosarcoma, Metastatic, Nose 1 (2%) Sarcoma Stromal, Metastatic, Uterus 1 (2%) Nose (49) (50) (49) (49) Osteosarcoma 1 (2%) Trachea (49) (50) (49) (49) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Harderian Gland (3) (2) Adenoma 3 (100%) 2 (100%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (49) (50) (49) (49) Bilateral, Osteosarcoma, Metastatic, Bone 1 (2%) Urinary Bladder (48) (50) (48) (49) Histiocytic Sarcoma 1 (2%) ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS Multiple Organs *(49) *(50) *(49) *(49) Histiocytic Sarcoma 1 (2%) Lymphoma Malignant Histiocytic 1 (2%) 2 (4%) 1 (2%) Lymphoma Malignant Lymphocytic 4 (8%) 7 (14%) 5 (10%) 2 (4%) Lymphoma Malignant Mixed 1 (2%) 2 (4%) 2 (4%) 2 (4%) Lymphoma Malignant Undifferentiated Cell 1 (2%) 1 (2%) * Number of animals with any tissue examined microscopically Page 5 NTP Experiment-Test: 05130-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC C. I. DIRECT BLUE 218 Date: 09/16/94 Route: DOSED FEED Time: 23:49:54 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE CONTROL 1000 PPM 3000 PPM 10000PPM FEMALE LOW FEM MID FEM HIGH FEM ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS - cont Multiple Organs *(49) *(50) *(49) *(49) ____________________________________________________________________________________________________________________________________ Page 6 NTP Experiment-Test: 05130-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC C. I. DIRECT BLUE 218 Date: 09/16/94 Route: DOSED FEED Time: 23:49:54 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE CONTROL 1000 PPM 3000 PPM 10000PPM FEMALE LOW FEM MID FEM HIGH FEM ____________________________________________________________________________________________________________________________________ TUMOR SUMMARY Total Animals with Primary Neoplasms (b) 29 35 34 46 Total Primary Neoplasms 37 59 52 78 Total Animals with Benign Neoplasms 20 21 26 42 Total Benign Neoplasms 23 29 33 53 Total Animals with Malignant Neoplasms 14 24 17 24 Total Malignant Neoplasms 14 30 19 25 Total Animals with Metastatic Neoplasms 2 6 3 2 Total Metastatic Neoplasm 4 20 4 2 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 7 NTP Experiment-Test: 05130-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC C. I. DIRECT BLUE 218 Date: 09/16/94 Route: DOSED FEED Time: 23:49:54 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE CONTROL 1000 PPM 3000 PPM 10000PPM MALE LOW MALE MID MALE HIGHMALE ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially in Study 60 60 60 60 Scheduled Sacrifice 9 10 10 10 Early Deaths Accidently Killed 1 Natural Death 3 2 5 4 Moribund Sacrifice 2 2 3 1 Survivors Terminal Sacrifice 44 46 42 45 Missing 1 Animals Examined Microscopically 50 50 50 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Gallbladder (45) (47) (46) (47) Intestine Large, Colon (48) (50) (50) (49) Intestine Large, Cecum (48) (49) (48) (48) Intestine Small, Duodenum (48) (48) (47) (49) Adenoma 1 (2%) Intestine Small, Jejunum (49) (49) (49) (49) Carcinoma 1 (2%) 3 (6%) Intestine Small, Ileum (49) (49) (47) (48) Liver (50) (50) (50) (50) Hemangioma 1 (2%) Hemangiosarcoma 1 (2%) 1 (2%) Hemangiosarcoma, Metastatic, Spleen 1 (2%) 1 (2%) Hepatoblastoma 1 (2%) Hepatocellular Carcinoma 7 (14%) 3 (6%) 8 (16%) 17 (34%) Hepatocellular Adenoma 12 (24%) 9 (18%) 7 (14%) 9 (18%) Hepatocellular Adenoma, Multiple 4 (8%) 10 (20%) 10 (20%) 31 (62%) Histiocytic Sarcoma 1 (2%) 1 (2%) Mast Cell Tumor Malignant, Metastatic, Spleen 1 (2%) Sarcoma, Metastatic, Uncertain Primary Site 1 (2%) Mesentery (3) (1) Sarcoma, Metastatic, Uncertain Primary Site 1 (100%) Pancreas (49) (50) (50) (50) Sarcoma, Metastatic, Uncertain Primary Site 1 (2%) Salivary Glands (49) (50) (50) (50) Stomach, Forestomach (50) (50) (50) (50) Squamous Cell Papilloma 1 (2%) 1 (2%) Stomach, Glandular (50) (50) (50) (50) ____________________________________________________________________________________________________________________________________ Page 8 NTP Experiment-Test: 05130-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC C. 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DIRECT BLUE 218 Date: 09/16/94 Route: DOSED FEED Time: 23:49:54 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE CONTROL 1000 PPM 3000 PPM 10000PPM MALE LOW MALE MID MALE HIGHMALE ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (50) (50) (50) (50) Hemangiosarcoma 1 (2%) Sarcoma 1 (2%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (50) (50) (50) (50) Adenoma 3 (6%) 1 (2%) Capsule, Adenoma 1 (2%) Pituitary Gland (49) (48) (48) (48) Thyroid Gland (50) (50) (50) (50) Follicular Cell, Adenoma 2 (4%) 2 (4%) 2 (4%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM Tissue NOS (1) (2) (1) Sarcoma, Metastatic, Uncertain Primary Site 1 (50%) Abdominal, Hemangiosarcoma, Metastatic, Spleen 1 (50%) ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Ductus Deferens (1) Epididymis (50) (50) (50) (50) Histiocytic Sarcoma 1 (2%) Sarcoma 1 (2%) 1 (2%) Preputial Gland (29) (23) (23) (21) Prostate (50) (49) (50) (50) Histiocytic Sarcoma 1 (2%) Seminal Vesicle (50) (50) (50) (50) Testes (50) (50) (50) (50) Histiocytic Sarcoma 1 (2%) Interstitial Cell, Adenoma 1 (2%) 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (50) (50) (50) (50) Histiocytic Sarcoma 1 (2%) Mast Cell Tumor Malignant, Metastatic, Spleen 1 (2%) Lymph Node (4) (1) (2) (3) Alveolar/Bronchiolar Carcinoma, Metastatic, Lung 1 (50%) Page 9 NTP Experiment-Test: 05130-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC C. I. DIRECT BLUE 218 Date: 09/16/94 Route: DOSED FEED Time: 23:49:54 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE CONTROL 1000 PPM 3000 PPM 10000PPM MALE LOW MALE MID MALE HIGHMALE ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - cont Bronchial, Alveolar/Bronchiolar Carcinoma, Metastatic, Lung 1 (50%) Mediastinal, Alveolar/Bronchiolar Carcinoma, Metastatic, Lung 1 (50%) Lymph Node, Mandibular (46) (49) (49) (48) Lymph Node, Mesenteric (48) (49) (50) (50) Sarcoma, Metastatic, Uncertain Primary Site 1 (2%) Spleen (49) (50) (50) (50) Hemangioma 1 (2%) Hemangiosarcoma 1 (2%) 1 (2%) Histiocytic Sarcoma 1 (2%) Mast Cell Tumor Malignant 1 (2%) Sarcoma, Metastatic, Uncertain Primary Site 1 (2%) Thymus (49) (45) (46) (42) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Skin (50) (50) (50) (50) Subcutaneous Tissue, Fibroma 1 (2%) Subcutaneous Tissue, Hemangioma 1 (2%) Subcutaneous Tissue, Hemangiosarcoma 1 (2%) Subcutaneous Tissue, Lipoma 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Skeletal Muscle (1) Sarcoma 1 (100%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM None ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (50) (50) (50) Alveolar/Bronchiolar Adenoma 12 (24%) 8 (16%) 7 (14%) 3 (6%) Alveolar/Bronchiolar Adenoma, Multiple 1 (2%) 1 (2%) 1 (2%) Alveolar/Bronchiolar Carcinoma 1 (2%) 3 (6%) 2 (4%) 1 (2%) Hepatocellular Carcinoma, Metastatic, Liver 1 (2%) 3 (6%) 3 (6%) Sarcoma, Metastatic, Uncertain Primary Site 1 (2%) Sarcoma, Metastatic, Skeletal Muscle 1 (2%) Nose (50) (50) (50) (50) ____________________________________________________________________________________________________________________________________ Page 10 NTP Experiment-Test: 05130-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC C. 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DIRECT BLUE 218 Date: 09/16/94 Route: DOSED FEED Time: 23:49:54 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE CONTROL 1000 PPM 3000 PPM 10000PPM MALE LOW MALE MID MALE HIGHMALE ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Ear (2) Pinna, Sarcoma 1 (50%) Harderian Gland (3) (4) (4) Adenoma 3 (100%) 3 (75%) 4 (100%) Bilateral, Adenoma 1 (25%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (50) (50) (50) Renal Tubule, Adenoma 2 (4%) 1 (2%) 1 (2%) Renal Tubule, Carcinoma 1 (2%) Urinary Bladder (50) (50) (50) (50) ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS Multiple Organs *(50) *(50) *(50) *(50) Histiocytic Sarcoma 1 (2%) 1 (2%) Lymphoma Malignant Lymphocytic 2 (4%) 1 (2%) 2 (4%) 2 (4%) Lymphoma Malignant Mixed 3 (6%) ____________________________________________________________________________________________________________________________________ * Number of animals with any tissue examined microscopically Page 11 NTP Experiment-Test: 05130-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC C. 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DIRECT BLUE 218 Date: 09/16/94 Route: DOSED FEED Time: 23:49:54 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE CONTROL 1000 PPM 3000 PPM 10000PPM MALE LOW MALE MID MALE HIGHMALE ____________________________________________________________________________________________________________________________________ TUMOR SUMMARY Total Animals with Primary Neoplasms (b) 31 37 28 46 Total Primary Neoplasms 51 59 46 78 Total Animals with Benign Neoplasms 25 31 21 42 Total Benign Neoplasms 35 45 31 51 Total Animals with Malignant Neoplasms 14 14 12 24 Total Malignant Neoplasms 16 14 15 27 Total Animals with Metastatic Neoplasms 2 3 4 4 Total Metastatic Neoplasm 3 10 6 4 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 12 ------------------------------------------------------------ ---------- END OF REPORT ---------- ------------------------------------------------------------