TDMS Study 96007-04 Pathology Tables
NTP Experiment-Test: 96007-04 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION (DIOXIN MIXTURE) Date: 09/29/03 Route: GAVAGE Time: 12:03:26 FINAL#4/RATS Facility: Battelle Columbus Laboratory Chemical CAS #: TEFDIOXINMIX Lock Date: 09/12/01 Cage Range: All Reasons For Removal: 25018 Dosing Accident 25019 Moribund Sacrifice 25020 Natural Death 25021 Terminal Sacrifice 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: 96007-04 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION (DIOXIN MIXTURE) Date: 09/29/03 Route: GAVAGE Time: 12:03:26 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE TERT.MIX TERT.MIX TERT.MIX TERT.MIX TERT.MIX CONTROL TEQ=10 TEQ=22 TEQ=46 TEQ=100 ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially in Study 98 98 98 98 98 Early Deaths Moribund Sacrifice 26 25 22 25 33 Natural Death 11 5 6 4 10 Dosing Accident 1 1 2 Survivors Terminal Sacrifice 16 23 24 23 8 Animals Examined Microscopically 53 53 53 53 53 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Colon (53) (52) (53) (53) (51) Carcinoma 1 (2%) Intestine Large, Rectum (52) (53) (53) (53) (52) Polyp Adenomatous 1 (2%) Schwannoma Malignant, Metastatic, Uterus 1 (2%) Intestine Large, Cecum (51) (53) (53) (53) (51) Intestine Small, Duodenum (52) (53) (53) (53) (52) Carcinoma 1 (2%) Intestine Small, Jejunum (52) (53) (53) (53) (50) Leiomyosarcoma 1 (2%) 1 (2%) Intestine Small, Ileum (52) (53) (53) (53) (50) Liver (53) (53) (53) (53) (51) Cholangiocarcinoma 2 (4%) 5 (9%) 5 (10%) Cholangiocarcinoma, Multiple 2 (4%) 4 (8%) Hepatocellular Adenoma 1 (2%) 1 (2%) 1 (2%) 9 (18%) Hepatocellular Adenoma, Multiple 2 (4%) Histiocytic Sarcoma 1 (2%) Mesentery (1) (2) (6) (8) Lipoma 1 (17%) Oral Mucosa (10) (18) (19) (29) (31) Gingival, Squamous Cell Carcinoma 1 (10%) 1 (6%) 2 (6%) Pancreas (52) (53) (53) (53) (51) Acinus, Adenoma 2 (4%) Acinus, Carcinoma 1 (2%) 2 (4%) Salivary Glands (53) (53) (53) (53) (53) Carcinoma 1 (2%) Schwannoma Malignant, Metastatic, Skin 1 (2%) Stomach, Forestomach (53) (53) (53) (53) (52) Page 2 NTP Experiment-Test: 96007-04 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION (DIOXIN MIXTURE) Date: 09/29/03 Route: GAVAGE Time: 12:03:26 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE TERT.MIX TERT.MIX TERT.MIX TERT.MIX TERT.MIX CONTROL TEQ=10 TEQ=22 TEQ=46 TEQ=100 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - cont Stomach, Glandular (53) (53) (53) (53) (52) Tongue (1) (1) Squamous Cell Carcinoma, Metastatic, Oral Mucosa 1 (100%) Tooth (24) (23) (27) (37) (30) Peridontal Tissue, Fibrosarcoma 1 (4%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Blood Vessel (53) (53) (53) (52) (53) Aorta, Adventitia, Carcinoma, Metastatic, Mammary Gland 1 (2%) Heart (53) (53) (53) (52) (53) Fibrous Histiocytoma, Metastatic, Skeletal Muscle 1 (2%) Schwannoma Malignant 2 (4%) 1 (2%) 3 (6%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (52) (53) (53) (53) (51) Adenoma 1 (2%) 1 (2%) Carcinoma 1 (2%) 1 (2%) Adrenal Medulla (52) (53) (53) (53) (51) Pheochromocytoma Benign 4 (8%) 3 (6%) 4 (8%) 4 (8%) 1 (2%) Bilateral, Pheochromocytoma Benign 1 (2%) 1 (2%) Islets, Pancreatic (52) (53) (53) (53) (51) Adenoma 1 (2%) 1 (2%) 1 (2%) 1 (2%) Carcinoma 1 (2%) Parathyroid Gland (50) (50) (49) (47) (52) Adenoma 1 (2%) Pituitary Gland (53) (53) (53) (53) (53) Carcinoma 1 (2%) Pars Distalis, Adenoma 28 (53%) 29 (55%) 22 (42%) 20 (38%) 10 (19%) Thyroid Gland (53) (53) (51) (52) (51) Bilateral, C-Cell, Adenoma 2 (4%) 2 (4%) 3 (6%) 1 (2%) Bilateral, Follicular Cell, Carcinoma 1 (2%) C-Cell, Adenoma 15 (28%) 8 (15%) 15 (29%) 8 (15%) 5 (10%) C-Cell, Carcinoma 2 (4%) 1 (2%) 1 (2%) Follicular Cell, Adenoma 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ Page 3 NTP Experiment-Test: 96007-04 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION (DIOXIN MIXTURE) Date: 09/29/03 Route: GAVAGE Time: 12:03:26 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE TERT.MIX TERT.MIX TERT.MIX TERT.MIX TERT.MIX CONTROL TEQ=10 TEQ=22 TEQ=46 TEQ=100 ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Ovary (52) (52) (53) (53) (51) Fibrous Histiocytoma, Metastatic, Skeletal Muscle 1 (2%) Granulosa Cell Tumor Malignant 1 (2%) 1 (2%) Granulosa Cell Tumor Benign 1 (2%) 1 (2%) Uterus (52) (53) (53) (53) (51) Carcinoma 1 (2%) 2 (4%) 2 (4%) 1 (2%) Hemangiosarcoma 1 (2%) Leiomyoma 2 (4%) Leiomyosarcoma 1 (2%) Polyp Stromal 3 (6%) 1 (2%) 2 (4%) 3 (6%) 2 (4%) Polyp Stromal, Multiple 1 (2%) 1 (2%) Schwannoma Malignant 1 (2%) 1 (2%) 2 (4%) 1 (2%) Squamous Cell Carcinoma 1 (2%) Squamous Cell Papilloma 1 (2%) Cervix, Carcinoma 1 (2%) Cervix, Squamous Cell Carcinoma 1 (2%) 1 (2%) Serosa, Carcinoma, Metastatic, Uterus 1 (2%) Vagina (1) Schwannoma Malignant 1 (100%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (53) (53) (53) (53) (53) Lymph Node (4) (1) (2) (9) (11) Deep Cervical, Carcinoma, Metastatic, Thyroid Gland 1 (11%) Lymph Node, Mandibular (53) (53) (53) (53) (53) Lymph Node, Mesenteric (52) (53) (53) (53) (50) Spleen (52) (53) (53) (53) (51) Thymus (52) (48) (50) (53) (50) Fibrosarcoma, Metastatic, Skin 1 (2%) ____________________________________________________________________________________________________________________________________ Page 4 NTP Experiment-Test: 96007-04 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION (DIOXIN MIXTURE) Date: 09/29/03 Route: GAVAGE Time: 12:03:26 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE TERT.MIX TERT.MIX TERT.MIX TERT.MIX TERT.MIX CONTROL TEQ=10 TEQ=22 TEQ=46 TEQ=100 ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (53) (53) (53) (53) (52) Adenoacanthoma 1 (2%) Adenolipoma 1 (2%) Adenoma 1 (2%) Carcinoma 5 (9%) 6 (11%) 3 (6%) 5 (9%) 1 (2%) Carcinoma, Multiple 1 (2%) Fibroadenoma 21 (40%) 17 (32%) 19 (36%) 20 (38%) 15 (29%) Fibroadenoma, Multiple 13 (25%) 10 (19%) 16 (30%) 8 (15%) 3 (6%) Skin (53) (53) (53) (53) (53) Fibroma 1 (2%) 2 (4%) 2 (4%) 3 (6%) Fibrosarcoma 1 (2%) 1 (2%) Pilomatrixoma 1 (2%) Schwannoma Malignant 1 (2%) Schwannoma Malignant, Metastatic, Uterus 1 (2%) Squamous Cell Papilloma 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Skeletal Muscle (1) Fibrous Histiocytoma 1 (100%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (53) (53) (53) (53) (53) Carcinoma, Metastatic, Kidney 1 (2%) Carcinoma, Metastatic, Pituitary Gland 1 (2%) Granular Cell Tumor Malignant 1 (2%) Medulloblastoma Mal 1 (2%) 1 (2%) Oligodendroglioma Malignant 1 (2%) Meninges, Meningioma Malignant 1 (2%) Spinal Cord (1) (1) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (53) (53) (53) (53) (53) Alveolar/Bronchiolar Adenoma 1 (2%) 1 (2%) Carcinoma, Metastatic, Mammary Gland 3 (6%) 1 (2%) 2 (4%) Carcinoma, Metastatic, Uterus 1 (2%) Carcinoma, Metastatic, Adrenal Cortex 1 (2%) Page 5 NTP Experiment-Test: 96007-04 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION (DIOXIN MIXTURE) Date: 09/29/03 Route: GAVAGE Time: 12:03:26 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE TERT.MIX TERT.MIX TERT.MIX TERT.MIX TERT.MIX CONTROL TEQ=10 TEQ=22 TEQ=46 TEQ=100 ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM - cont Cystic Keratinizing Epithelioma 2 (4%) 9 (17%) Cystic Keratinizing Epithelioma, Multiple 11 (21%) Fibrosarcoma, Metastatic, Skin 1 (2%) Fibrous Histiocytoma, Metastatic, Skeletal Muscle 1 (2%) Histiocytic Sarcoma 1 (2%) Schwannoma Malignant, Metastatic, Skin 1 (2%) Mediastinum, Carcinoma, Metastatic, Mammary Gland 1 (2%) Mediastinum, Fibrous Histiocytoma, Metastatic, Skeletal Muscle 1 (2%) Nose (53) (53) (53) (53) (53) Schwannoma Malignant 1 (2%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Harderian Gland (53) (53) (52) (53) (53) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (52) (53) (53) (53) (51) Hemangiosarcoma 1 (2%) Nephroblastoma 1 (2%) Bilateral, Renal Tubule, Carcinoma 1 (2%) Renal Tubule, Carcinoma 1 (2%) Transitional Epithelium, Papilloma 1 (2%) ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS Multiple Organs *(53) *(53) *(53) *(53) *(53) Adenolipoma 1 (2%) Histiocytic Sarcoma 1 (2%) Lymphoma Malignant 2 (4%) 1 (2%) 1 (2%) 2 (4%) ____________________________________________________________________________________________________________________________________ * Number of animals with any tissue examined microscopically Page 6 NTP Experiment-Test: 96007-04 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION (DIOXIN MIXTURE) Date: 09/29/03 Route: GAVAGE Time: 12:03:26 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE TERT.MIX TERT.MIX TERT.MIX TERT.MIX TERT.MIX CONTROL TEQ=10 TEQ=22 TEQ=46 TEQ=100 ____________________________________________________________________________________________________________________________________ TUMOR SUMMARY Total Animals with Primary Neoplasms (b) 51 46 50 50 45 Total Primary Neoplasms 115 94 118 99 93 Total Animals with Benign Neoplasms 45 43 46 43 39 Total Benign Neoplasms 92 77 97 75 68 Total Animals with Malignant Neoplasms 18 14 19 21 21 Total Malignant Neoplasms 23 17 21 23 25 Total Animals with Metastatic Neoplasms 7 2 2 4 1 Total Metastatic Neoplasm 11 5 2 5 2 Total Animals with Malignant Neoplasms Uncertain Primary Site Total Animals with Neoplasms Uncertain- Benign or Malignant 1 Total Uncertain Neoplasms 1 ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion b Primary tumors: all tumors except metastatic tumors Page 7 ------------------------------------------------------------ ---------- END OF REPORT ---------- ------------------------------------------------------------