TDMS Study 05102-06 Pathology Tables
INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) BENZETHONIUM CHLORIDE NTP Experiment-Test: 05102-06 Report: PEIRPT05 Study Type: CHRONIC Date: 05/19/95 Route: DERMAL,SOLUTION Time: 18:39:19 Facility: Battelle Columbus Laboratory Chemical CAS #: 121-54-0 Lock Date: 01/22/92 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: 05102-06 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC BENZETHONIUM CHLORIDE Date: 05/19/95 Route: DERMAL,SOLUTION Time: 18:39:19 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0MG/KG .15MG/KG 0.5MG/KG 1.5MG/KG ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially in Study 60 60 60 60 Scheduled Sacrifice 8 7 10 6 Early Deaths Moribund Sacrifice 10 4 8 13 Natural Death 3 15 9 7 Accidently Killed 1 Survivors Terminal Sacrifice 38 34 31 34 Other 2 Animals Examined Microscopically 60 60 58 60 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Gallbladder (60) (59) Histiocytic Sarcoma 1 (2%) Intestine Large, Rectum (60) (59) Liposarcoma, Metastatic, Skeletal Muscle 1 (2%) Intestine Large, Cecum (60) (59) Intestine Small, Jejunum (60) (58) Carcinoma 1 (2%) Hemangiosarcoma 1 (2%) Liver (60) (60) Hemangioma 1 (2%) Hemangiosarcoma 1 (2%) Hemangiosarcoma, Metastatic, Spleen 1 (2%) Hepatocellular Carcinoma 7 (12%) 10 (17%) Hepatocellular Carcinoma, Multiple 5 (8%) 1 (2%) Hepatocellular Adenoma 10 (17%) 13 (22%) Hepatocellular Adenoma, Multiple 11 (18%) 6 (10%) Hepatocholangiocarcinoma, Multiple 1 (2%) Histiocytic Sarcoma 3 (5%) Plasma Cell Tumor Malignant, Metastatic, Spleen 1 (2%) Mesentery (10) (9) Hemangioma 1 (10%) Hepatocholangiocarcinoma, Metastatic, Liver 1 (11%) Histiocytic Sarcoma 1 (10%) Myxosarcoma, Metastatic, Skin 1 (10%) Pancreas (60) (59) Histiocytic Sarcoma 1 (2%) Leiomyosarcoma, Metastatic, Uterus 1 (2%) Salivary Glands (60) (60) Page 2 NTP Experiment-Test: 05102-06 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC BENZETHONIUM CHLORIDE Date: 05/19/95 Route: DERMAL,SOLUTION Time: 18:39:19 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0MG/KG .15MG/KG 0.5MG/KG 1.5MG/KG ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - cont Stomach, Forestomach (59) (59) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (60) (60) Plasma Cell Tumor Malignant, Metastatic, Spleen 1 (2%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (60) (60) Histiocytic Sarcoma 1 (2%) Pituitary Gland (60) (55) Histiocytic Sarcoma 1 (2%) Pars Distalis, Adenoma 6 (10%) 5 (9%) Thyroid Gland (60) (60) Follicular Cell, Adenoma 3 (5%) 1 (2%) Follicular Cell, Carcinoma 1 (2%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Ovary (60) (58) Cystadenoma 3 (5%) 2 (3%) Hemangioma 1 (2%) Histiocytic Sarcoma 2 (3%) Uterus (60) (59) Carcinoma 1 (2%) Histiocytic Sarcoma 3 (5%) 1 (2%) Leiomyosarcoma 1 (2%) Polyp Stromal 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Blood (1) Bone Marrow (60) (59) Hemangiosarcoma, Metastatic, Spleen 3 (5%) Histiocytic Sarcoma 2 (3%) Plasma Cell Tumor Malignant, Metastatic, Page 3 NTP Experiment-Test: 05102-06 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC BENZETHONIUM CHLORIDE Date: 05/19/95 Route: DERMAL,SOLUTION Time: 18:39:19 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0MG/KG .15MG/KG 0.5MG/KG 1.5MG/KG ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - cont Spleen 1 (2%) Lymph Node (7) (3) Lumbar, Histiocytic Sarcoma 1 (14%) Mediastinal, Histiocytic Sarcoma 1 (14%) Pancreatic, Hepatocholangiocarcinoma, Metastatic, Liver 1 (33%) Lymph Node, Mandibular (60) (60) Hemangioma 1 (2%) Histiocytic Sarcoma 3 (5%) Plasma Cell Tumor Malignant, Metastatic, Spleen 1 (2%) Lymph Node, Mesenteric (57) (54) Histiocytic Sarcoma 3 (5%) Plasma Cell Tumor Malignant, Metastatic, Spleen 1 (2%) Spleen (60) (59) Hemangiosarcoma 1 (2%) 3 (5%) Histiocytic Sarcoma 1 (2%) Plasma Cell Tumor Malignant 1 (2%) Thymus (49) (51) Plasma Cell Tumor Malignant, Metastatic, Spleen 1 (2%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Skin (60) (59) (58) (59) Subcutaneous Tissue, Fibrosarcoma 2 (3%) Subcutaneous Tissue, Hemangiosarcoma 1 (2%) Subcutaneous Tissue, Sarcoma 1 (2%) Skin, Inguinal (2) (1) (1) Skin, Site of Application-No Mass (5) (10) (9) (27) Subcutaneous Tissue, Hemangioma 1 (20%) Skin, Site of Application-Mass (1) (1) Subcutaneous Tissue, Myxosarcoma, Multiple 1 (100%) Subcutaneous Tissue, Sarcoma 1 (100%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (60) (59) Liposarcoma, Metastatic, Skeletal Muscle 1 (2%) Skeletal Muscle (4) Hemangiosarcoma, Metastatic, Spleen 1 (25%) Leiomyosarcoma, Metastatic, Uterus 1 (25%) Liposarcoma 1 (25%) ____________________________________________________________________________________________________________________________________ Page 4 NTP Experiment-Test: 05102-06 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC BENZETHONIUM CHLORIDE Date: 05/19/95 Route: DERMAL,SOLUTION Time: 18:39:19 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0MG/KG .15MG/KG 0.5MG/KG 1.5MG/KG ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Spinal Cord (2) Hemangiosarcoma, Metastatic, Spleen 1 (50%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (60) (60) Alveolar/Bronchiolar Adenoma 1 (2%) 2 (3%) Alveolar/Bronchiolar Carcinoma 1 (2%) 1 (2%) Carcinoma, Metastatic, Harderian Gland 1 (2%) Hepatocellular Carcinoma, Metastatic, Liver 5 (8%) 3 (5%) Hepatocholangiocarcinoma, Metastatic, Liver 1 (2%) Histiocytic Sarcoma 2 (3%) Liposarcoma, Metastatic, Skeletal Muscle 1 (2%) Plasma Cell Tumor Malignant, Metastatic, Spleen 1 (2%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Harderian Gland (44) (35) Adenoma 2 (5%) 2 (6%) Carcinoma 2 (5%) 1 (3%) Zymbal's Gland (1) Carcinoma 1 (100%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (60) (60) Histiocytic Sarcoma 3 (5%) Plasma Cell Tumor Malignant, Metastatic, Spleen 1 (2%) Urinary Bladder (58) (59) ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS Multiple Organs *(60) *(60) *(58) *(60) Histiocytic Sarcoma 3 (5%) 1 (2%) Leukemia Lymphocytic 1 (2%) Lymphoma Malignant Lymphocytic 1 (2%) 1 (2%) 2 (3%) Lymphoma Malignant Mixed 5 (8%) 3 (5%) Lymphoma Malignant Undifferentiated Cell 1 (2%) ____________________________________________________________________________________________________________________________________ * Number of animals with any tissue examined microscopically Page 5 NTP Experiment-Test: 05102-06 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC BENZETHONIUM CHLORIDE Date: 05/19/95 Route: DERMAL,SOLUTION Time: 18:39:19 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0MG/KG .15MG/KG 0.5MG/KG 1.5MG/KG ____________________________________________________________________________________________________________________________________ TUMOR SUMMARY Total Animals with Primary Neoplasms (b) 42 1 1 43 Total Primary Neoplasms 75 1 1 63 Total Animals with Benign Neoplasms 29 29 Total Benign Neoplasms 40 34 Total Animals with Malignant Neoplasms 27 1 1 27 Total Malignant Neoplasms 35 1 1 29 Total Animals with Metastatic Neoplasms 9 8 Total Metastatic Neoplasm 16 16 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: 05102-06 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC BENZETHONIUM CHLORIDE Date: 05/19/95 Route: DERMAL,SOLUTION Time: 18:39:19 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0MG/KG .15MG/KG 0.5MG/KG 1.5MG/KG ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially in Study 60 60 60 60 Scheduled Sacrifice 10 9 9 10 Early Deaths Moribund Sacrifice 3 8 4 9 Natural Death 4 4 4 2 Survivors Terminal Sacrifice 43 38 42 39 Other 1 1 Animals Examined Microscopically 60 59 59 60 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Cecum (60) (60) Leiomyosarcoma 1 (2%) Intestine Small, Duodenum (60) (60) Adenoma 1 (2%) Intestine Small, Jejunum (60) (60) Liver (60) (60) Hemangioma 1 (2%) Hemangiosarcoma 2 (3%) Hemangiosarcoma, Multiple 1 (2%) 2 (3%) Hemangiosarcoma, Metastatic, Skin 1 (2%) Hemangiosarcoma, Metastatic, Spleen 1 (2%) Hepatoblastoma 1 (2%) Hepatocellular Carcinoma 10 (17%) 14 (23%) Hepatocellular Carcinoma, Multiple 2 (3%) 2 (3%) Hepatocellular Adenoma 15 (25%) 16 (27%) Hepatocellular Adenoma, Multiple 13 (22%) 13 (22%) Histiocytic Sarcoma 1 (2%) Mesentery (5) (5) Hemangioma 1 (20%) 1 (20%) Histiocytic Sarcoma 1 (20%) Stomach, Glandular (60) (60) Carcinoid Tumor Malignant 1 (2%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (60) (60) Hemangiosarcoma, Metastatic, Liver 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ Page 7 NTP Experiment-Test: 05102-06 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC BENZETHONIUM CHLORIDE Date: 05/19/95 Route: DERMAL,SOLUTION Time: 18:39:19 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0MG/KG .15MG/KG 0.5MG/KG 1.5MG/KG ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (60) (60) Histiocytic Sarcoma 1 (2%) Adrenal Medulla (60) (60) Pheochromocytoma Benign 1 (2%) Islets, Pancreatic (59) (60) Adenoma 2 (3%) 1 (2%) Pituitary Gland (58) (58) Histiocytic Sarcoma 1 (2%) Thyroid Gland (60) (60) Hemangiosarcoma, Metastatic, Spleen 1 (2%) Follicular Cell, Adenoma 1 (2%) Follicular Cell, Carcinoma 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Epididymis (60) (59) Histiocytic Sarcoma 1 (2%) Testes (60) (60) Interstitial Cell, Adenoma 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (60) (60) Hemangiosarcoma, Metastatic, Liver 1 (2%) Hemangiosarcoma, Metastatic, Skin 1 (2%) Hemangiosarcoma, Metastatic, Spleen 1 (2%) Histiocytic Sarcoma 1 (2%) Lymph Node (3) (2) Lymph Node, Mandibular (59) (58) Lymph Node, Mesenteric (57) (57) Spleen (60) (60) Hemangiosarcoma 3 (5%) Hemangiosarcoma, Metastatic, Liver 1 (2%) Histiocytic Sarcoma 1 (2%) Thymus (41) (49) ____________________________________________________________________________________________________________________________________ Page 8 NTP Experiment-Test: 05102-06 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC BENZETHONIUM CHLORIDE Date: 05/19/95 Route: DERMAL,SOLUTION Time: 18:39:19 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0MG/KG .15MG/KG 0.5MG/KG 1.5MG/KG ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Skin (60) (59) (59) (60) Melanoma Benign 1 (2%) Subcutaneous Tissue, Hemangioma 1 (2%) Subcutaneous Tissue, Hemangiosarcoma 1 (2%) 1 (2%) Subcutaneous Tissue, Hemangiosarcoma, Metastatic, Spleen 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM None ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (60) (60) Histiocytic Sarcoma 1 (2%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (60) (60) Alveolar/Bronchiolar Adenoma 11 (18%) 7 (12%) Alveolar/Bronchiolar Adenoma, Multiple 2 (3%) 1 (2%) Alveolar/Bronchiolar Carcinoma 1 (2%) Alveolar/Bronchiolar Carcinoma, Multiple 2 (3%) Carcinoma, Metastatic, Harderian Gland 1 (2%) Carcinoma, Metastatic, Thyroid Gland 1 (2%) Hepatocellular Carcinoma, Metastatic, Liver 2 (3%) 5 (8%) Histiocytic Sarcoma 1 (2%) Nose (60) (60) Glands, Carcinoma 1 (2%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Ear (1) (2) Fibrosarcoma 1 (100%) 1 (50%) Harderian Gland (43) (38) Adenoma 2 (5%) 3 (8%) Carcinoma 1 (2%) ____________________________________________________________________________________________________________________________________ Page 9 NTP Experiment-Test: 05102-06 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC BENZETHONIUM CHLORIDE Date: 05/19/95 Route: DERMAL,SOLUTION Time: 18:39:19 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0MG/KG .15MG/KG 0.5MG/KG 1.5MG/KG ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (60) (60) Histiocytic Sarcoma 1 (2%) ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS Multiple Organs *(60) *(59) *(59) *(60) Histiocytic Sarcoma 1 (2%) Lymphoma Malignant Lymphocytic 1 (2%) Lymphoma Malignant Mixed 1 (2%) 3 (5%) Lymphoma Malignant Undifferentiated Cell 1 (2%) ____________________________________________________________________________________________________________________________________ * Number of animals with any tissue examined microscopically Page 10 NTP Experiment-Test: 05102-06 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC BENZETHONIUM CHLORIDE Date: 05/19/95 Route: DERMAL,SOLUTION Time: 18:39:19 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0MG/KG .15MG/KG 0.5MG/KG 1.5MG/KG ____________________________________________________________________________________________________________________________________ TUMOR SUMMARY Total Animals with Primary Neoplasms (b) 48 44 Total Primary Neoplasms 72 81 Total Animals with Benign Neoplasms 39 34 Total Benign Neoplasms 49 47 Total Animals with Malignant Neoplasms 18 24 Total Malignant Neoplasms 23 34 Total Animals with Metastatic Neoplasms 4 8 Total Metastatic Neoplasm 8 11 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 ---------- ------------------------------------------------------------