TDMS Study 96007-03 Pathology Tables
NTP Experiment-Test: 96007-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION (TCDD) Date: 09/30/03 Route: GAVAGE Time: 08:37:13 FINAL # 3 RATS Facility: Battelle Columbus Laboratory Chemical CAS #: 1746-01-6 Lock Date: 06/28/01 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: 96007-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION (TCDD) Date: 09/30/03 Route: GAVAGE Time: 08:37:13 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 0 NG/KG 3 NG/KG 10 NG/KG 22 NG/KG 46 NG/KG 100 NG/KG ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially in Study 98 98 98 98 98 98 Early Deaths Moribund Sacrifice 19 27 15 19 17 17 Natural Death 9 6 10 15 14 15 Dosing Accident 5 Survivors Terminal Sacrifice 25 21 23 19 22 21 Animals Examined Microscopically 53 54 53 53 53 53 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Rectum (52) (54) (53) (52) (53) (53) Carcinoma 1 (2%) Intestine Small, Jejunum (51) (54) (53) (53) (53) (52) Leiomyoma 1 (2%) Liver (53) (54) (53) (53) (53) (53) Carcinoma, Metastatic, Pancreas 2 (4%) Carcinoma, Metastatic, Uterus 2 (4%) Cholangiocarcinoma 1 (2%) 3 (6%) 8 (15%) Cholangiocarcinoma, Multiple 1 (2%) 17 (32%) Hepatocellular Adenoma 1 (2%) 10 (19%) Hepatocellular Adenoma, Multiple 3 (6%) Hepatocholangioma 2 (4%) Mesentery (2) (2) (1) (6) (8) Carcinoma, Metastatic, Uterus 1 (17%) Schwannoma Malignant 1 (50%) Oral Mucosa (2) (9) (16) (16) (22) (29) Gingival, Squamous Cell Carcinoma 1 (50%) 2 (22%) 1 (6%) 4 (18%) 10 (34%) Pancreas (51) (54) (52) (53) (52) (51) Carcinoma, Metastatic, Uterus 1 (2%) Acinus, Adenoma 1 (2%) Acinus, Carcinoma 2 (4%) Stomach, Forestomach (53) (54) (53) (53) (53) (53) Squamous Cell Carcinoma 1 (2%) 1 (2%) Squamous Cell Papilloma 1 (2%) 1 (2%) Stomach, Glandular (53) (54) (53) (53) (53) (53) ____________________________________________________________________________________________________________________________________ Page 2 NTP Experiment-Test: 96007-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION (TCDD) Date: 09/30/03 Route: GAVAGE Time: 08:37:13 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 0 NG/KG 3 NG/KG 10 NG/KG 22 NG/KG 46 NG/KG 100 NG/KG ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (53) (54) (53) (52) (53) (52) Schwannoma Malignant 1 (2%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (53) (54) (53) (53) (53) (53) Adenoma 1 (2%) 2 (4%) 2 (4%) 1 (2%) 1 (2%) Carcinoma 1 (2%) Pheochromocytoma Benign 1 (2%) Capsule, Sarcoma, Metastatic, Skeletal Muscle 1 (2%) Adrenal Medulla (53) (54) (53) (53) (53) (53) Pheochromocytoma Malignant 1 (2%) Pheochromocytoma Benign 3 (6%) 2 (4%) 2 (4%) 3 (6%) 3 (6%) 3 (6%) Islets, Pancreatic (51) (54) (53) (53) (52) (52) Adenoma 1 (2%) 2 (4%) Carcinoma 1 (2%) Parathyroid Gland (46) (47) (47) (44) (45) (45) Adenoma 1 (2%) Pituitary Gland (53) (54) (52) (53) (53) (52) Adenoma 4 (8%) 1 (2%) Meningioma Malignant, Metastatic, Brain 1 (2%) Pars Distalis, Adenoma 18 (34%) 20 (37%) 26 (50%) 15 (28%) 20 (38%) 10 (19%) Pars Distalis, Adenoma, Multiple 3 (6%) Pars Intermedia, Adenoma 2 (4%) Thyroid Gland (52) (54) (53) (51) (53) (52) Bilateral, C-Cell, Adenoma 3 (6%) 3 (6%) 2 (4%) 2 (4%) 1 (2%) 3 (6%) C-Cell, Adenoma 17 (33%) 12 (22%) 15 (28%) 14 (27%) 12 (23%) 8 (15%) C-Cell, Carcinoma 1 (2%) 1 (2%) 2 (4%) Follicular Cell, Adenoma 1 (2%) Follicular Cell, Carcinoma 1 (2%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ Page 3 NTP Experiment-Test: 96007-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION (TCDD) Date: 09/30/03 Route: GAVAGE Time: 08:37:13 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 0 NG/KG 3 NG/KG 10 NG/KG 22 NG/KG 46 NG/KG 100 NG/KG ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Clitoral Gland (50) (52) (53) (52) (51) (53) Ovary (51) (53) (53) (53) (53) (53) Granulosa Cell Tumor Malignant 1 (2%) Thecoma Benign 1 (2%) Periovarian Tissue, Schwannoma Malignant, Metastatic, Uterus 1 (2%) Uterus (52) (53) (53) (53) (53) (53) Adenoma 1 (2%) Carcinoma 1 (2%) 2 (4%) 1 (2%) Carcinoma, Multiple 1 (2%) Hemangiosarcoma 1 (2%) Leiomyoma 1 (2%) Polyp Stromal 9 (17%) 7 (13%) 4 (8%) 8 (15%) 9 (17%) 7 (13%) Polyp Stromal, Multiple 2 (4%) 3 (6%) 1 (2%) 1 (2%) Squamous Cell Carcinoma 4 (8%) Squamous Cell Carcinoma, Multiple 1 (2%) Squamous Cell Papilloma 1 (2%) 1 (2%) Cervix, Carcinoma 1 (2%) Cervix, Schwannoma Malignant 1 (2%) Vagina (1) (1) (3) (3) (1) Schwannoma Malignant 1 (33%) 1 (100%) Schwannoma Malignant, Metastatic, Skin 1 (33%) Squamous Cell Carcinoma 1 (33%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (53) (54) (53) (53) (53) (53) Lymph Node (2) (6) (3) (5) (6) (9) Deep Cervical, Carcinoma, Metastatic, Thyroid Gland 1 (50%) Lumbar, Carcinoma, Metastatic, Uterus 1 (17%) Lymph Node, Mandibular (51) (54) (52) (50) (51) (52) Lymph Node, Mesenteric (52) (53) (53) (53) (53) (51) Spleen (51) (54) (53) (53) (52) (52) Hemangiosarcoma 1 (2%) Schwannoma Malignant, Metastatic, Uterus 1 (2%) Thymus (51) (52) (52) (49) (46) (42) Carcinoma, Metastatic, Lung 1 (2%) Histiocytic Sarcoma, Metastatic, Lung 1 (2%) ____________________________________________________________________________________________________________________________________ Page 4 NTP Experiment-Test: 96007-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION (TCDD) Date: 09/30/03 Route: GAVAGE Time: 08:37:13 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 0 NG/KG 3 NG/KG 10 NG/KG 22 NG/KG 46 NG/KG 100 NG/KG ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (53) (54) (53) (53) (53) (53) Adenoma 2 (4%) 1 (2%) 1 (2%) Carcinoma 3 (6%) 7 (13%) 4 (8%) 2 (4%) 2 (4%) Carcinoma, Multiple 1 (2%) 1 (2%) Fibroadenoma 21 (40%) 26 (48%) 17 (32%) 17 (32%) 24 (45%) 20 (38%) Fibroadenoma, Multiple 12 (23%) 14 (26%) 17 (32%) 12 (23%) 12 (23%) 4 (8%) Skin (53) (54) (53) (53) (53) (53) Basal Cell Carcinoma 1 (2%) 1 (2%) Fibroma 1 (2%) 2 (4%) 1 (2%) Fibrosarcoma 1 (2%) Keratoacanthoma 1 (2%) Lipoma 1 (2%) Myxosarcoma 1 (2%) Schwannoma Malignant 1 (2%) 2 (4%) 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (53) (54) (53) (53) (53) (53) Cranium, Schwannoma Malignant, Metastatic, Skin 1 (2%) Periosteum, Fibrosarcoma 1 (2%) Skeletal Muscle (1) (2) Fibrous Histiocytoma 1 (50%) Sarcoma 1 (100%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (53) (54) (53) (53) (53) (53) Glioma Malignant 1 (2%) Granular Cell Tumor Malignant 1 (2%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (53) (54) (53) (52) (53) (52) Alveolar/Bronchiolar Adenoma, Multiple 1 (2%) Alveolar/Bronchiolar Carcinoma 1 (2%) Carcinoma, Metastatic, Mammary Gland 1 (2%) Carcinoma, Metastatic, Pancreas 1 (2%) Carcinoma, Metastatic, Thyroid Gland 1 (2%) Page 5 NTP Experiment-Test: 96007-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION (TCDD) Date: 09/30/03 Route: GAVAGE Time: 08:37:13 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 0 NG/KG 3 NG/KG 10 NG/KG 22 NG/KG 46 NG/KG 100 NG/KG ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM - cont Cystic Keratinizing Epithelioma 7 (13%) Cystic Keratinizing Epithelioma, Multiple 2 (4%) Nephroblastoma, Metastatic, Kidney 1 (2%) Sarcoma, Metastatic, Skeletal Muscle 1 (2%) Mediastinum, Sarcoma 1 (2%) 1 (2%) Nose (53) (54) (53) (53) (53) (53) Squamous Cell Carcinoma, Metastatic, Oral Mucosa 1 (2%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Ear (2) (2) (1) Pinna, Neural Crest Tumor 1 (50%) Harderian Gland (53) (54) (53) (52) (53) (53) Squamous Cell Carcinoma, Metastatic, Oral Mucosa 3 (6%) Zymbal's Gland (1) Carcinoma 1 (100%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (53) (54) (53) (53) (53) (53) Nephroblastoma 2 (4%) 1 (2%) Schwannoma Malignant, Metastatic, Uterus 1 (2%) Stromal Nephroma 1 (2%) Urinary Bladder (52) (53) (53) (52) (53) (53) Polyp 1 (2%) Schwannoma Malignant, Metastatic, Uterus 1 (2%) Squamous Cell Carcinoma, Metastatic, Uterus 1 (2%) Transitional Epithelium, Carcinoma 1 (2%) ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS Multiple Organs *(53) *(54) *(53) *(53) *(53) *(53) Leukemia Granulocytic 1 (2%) Lymphoma Malignant 1 (2%) 1 (2%) 1 (2%) 2 (4%) ____________________________________________________________________________________________________________________________________ * Number of animals with any tissue examined microscopically Page 6 NTP Experiment-Test: 96007-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION (TCDD) Date: 09/30/03 Route: GAVAGE Time: 08:37:13 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 0 NG/KG 3 NG/KG 10 NG/KG 22 NG/KG 46 NG/KG 100 NG/KG ____________________________________________________________________________________________________________________________________ TUMOR SUMMARY Total Animals with Primary Neoplasms (b) 47 54 48 44 50 50 Total Primary Neoplasms 116 105 106 89 116 131 Total Animals with Benign Neoplasms 45 49 45 40 46 42 Total Benign Neoplasms 102 86 92 78 88 87 Total Animals with Malignant Neoplasms 13 19 13 11 24 34 Total Malignant Neoplasms 13 19 14 11 28 44 Total Animals with Metastatic Neoplasms 2 3 2 2 3 6 Total Metastatic Neoplasm 6 3 3 3 6 7 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 NTP Experiment-Test: 96007-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION (TCDD) Date: 09/30/03 Route: GAVAGE Time: 08:37:13 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 100 NG/ KG/STOP ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially in Study 50 Early Deaths Moribund Sacrifice 16 Natural Death 13 Survivors Terminal Sacrifice 21 Animals Examined Microscopically 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Rectum (50) Fibrous Histiocytoma, Metastatic, Skin 1 (2%) Intestine Small, Jejunum (50) Schwannoma Malignant, Metastatic, Heart 1 (2%) Liver (50) Cholangiocarcinoma 1 (2%) Cholangiocarcinoma, Multiple 1 (2%) Cholangioma 1 (2%) Fibrous Histiocytoma, Metastatic, Skin 1 (2%) Hepatocellular Adenoma 2 (4%) Schwannoma Malignant, Metastatic, Heart 1 (2%) Oral Mucosa (11) Gingival, Squamous Cell Carcinoma 5 (45%) Pancreas (49) Acinus, Carcinoma 1 (2%) Tongue (1) Squamous Cell Carcinoma 1 (100%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Blood Vessel (49) Aorta, Fibrous Histiocytoma, Metastatic, Skin 1 (2%) Heart (50) Carcinoma, Metastatic, Mammary Gland 1 (2%) Schwannoma Malignant 3 (6%) ____________________________________________________________________________________________________________________________________ Page 8 NTP Experiment-Test: 96007-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION (TCDD) Date: 09/30/03 Route: GAVAGE Time: 08:37:13 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 100 NG/ KG/STOP ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (50) Capsule, Schwannoma Malignant, Metastatic, Heart 1 (2%) Adrenal Medulla (50) Pheochromocytoma Complex 1 (2%) Pheochromocytoma Benign 1 (2%) Pituitary Gland (50) Pars Distalis, Adenoma 19 (38%) Thyroid Gland (49) Bilateral, C-Cell, Adenoma 2 (4%) C-Cell, Adenoma 11 (22%) C-Cell, Carcinoma 1 (2%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Ovary (49) Carcinoma, Metastatic, Uterus 1 (2%) Uterus (50) Carcinoma 2 (4%) Polyp Stromal 3 (6%) Polyp Stromal, Multiple 1 (2%) Squamous Cell Carcinoma 2 (4%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (50) Fibrous Histiocytoma, Metastatic, Skin 1 (2%) Lymph Node, Mesenteric (49) Fibrous Histiocytoma, Metastatic, Skin 1 (2%) Spleen (49) Fibrous Histiocytoma, Metastatic, Skin 1 (2%) Hemangiosarcoma 1 (2%) Schwannoma Malignant, Metastatic, Heart 1 (2%) Thymus (49) Fibrous Histiocytoma, Metastatic, Skin 1 (2%) Page 9 NTP Experiment-Test: 96007-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION (TCDD) Date: 09/30/03 Route: GAVAGE Time: 08:37:13 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 100 NG/ KG/STOP ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - cont Thymoma Malignant 1 (2%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (50) Adenolipoma 1 (2%) Carcinoma 1 (2%) Fibroadenoma 19 (38%) Fibroadenoma, Multiple 13 (26%) Skin (50) Fibroma 1 (2%) Fibrous Histiocytoma 1 (2%) Liposarcoma 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (50) Squamous Cell Carcinoma, Metastatic, Tongue 1 (2%) Skeletal Muscle (1) Fibrous Histiocytoma, Metastatic, Skin 1 (100%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM None ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) Carcinoma, Metastatic, Mammary Gland 1 (2%) Fibrous Histiocytoma, Metastatic, Skin 1 (2%) Schwannoma Malignant, Metastatic, Heart 1 (2%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM None ____________________________________________________________________________________________________________________________________ Page 10 NTP Experiment-Test: 96007-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION (TCDD) Date: 09/30/03 Route: GAVAGE Time: 08:37:13 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 100 NG/ KG/STOP ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) Fibrous Histiocytoma, Metastatic, Skin 1 (2%) ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS Multiple Organs *(50) Adenolipoma 1 (2%) Lymphoma Malignant 1 (2%) ____________________________________________________________________________________________________________________________________ * Number of animals with any tissue examined microscopically Page 11 NTP Experiment-Test: 96007-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION (TCDD) Date: 09/30/03 Route: GAVAGE Time: 08:37:13 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 100 NG/ KG/STOP ____________________________________________________________________________________________________________________________________ TUMOR SUMMARY Total Animals with Primary Neoplasms (b) 46 Total Primary Neoplasms 98 Total Animals with Benign Neoplasms 41 Total Benign Neoplasms 74 Total Animals with Malignant Neoplasms 19 Total Malignant Neoplasms 24 Total Animals with Metastatic Neoplasms 5 Total Metastatic Neoplasm 19 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 12 ------------------------------------------------------------ ---------- END OF REPORT ---------- ------------------------------------------------------------