NTP Experiment-Test: 96022-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC TEF EVALUATION (PCB MIXTURE;PCB 126/PCB 118) Date: 11/15/04 Route: GAVAGE Time: 11:12:15 CORE + STOP STUDY FINAL #1; REVISION #1 RATS Facility: Battelle Columbus Laboratory Chemical CAS #: TEFPCBMIX Lock Date: 11/04/02 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: 96022-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC TEF EVALUATION (PCB MIXTURE;PCB 126/PCB 118) Date: 11/15/04 Route: GAVAGE Time: 11:12:15 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially in Study 98 86 98 86 98 86 Early Deaths Moribund Sacrifice 21 20 21 23 43 44 Natural Death 5 14 8 13 10 22 Dosing Accident 2 Survivors Terminal Sacrifice 27 17 24 15 Animals Examined Microscopically 53 51 53 53 53 66 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Small, Jejunum (53) (51) (53) (53) (53) (66) Leiomyoma 1 (2%) 1 (2%) Liver (53) (51) (53) (53) (53) (65) Carcinoma, Metastatic, Pancreas 1 (2%) Cholangiocarcinoma 4 (8%) 7 (13%) 7 (13%) 5 (8%) Cholangiocarcinoma, Multiple 1 (2%) 12 (23%) 21 (40%) 7 (11%) Cholangioma 1 (2%) Hepatocellular Carcinoma 1 (2%) Hepatocellular Adenoma 2 (4%) 1 (2%) 2 (4%) 7 (13%) 3 (5%) Hepatocellular Adenoma, Multiple 2 (4%) 10 (19%) 2 (3%) Hepatocholangioma 1 (2%) 1 (2%) Hepatocholangioma, Multiple 1 (2%) Oral Mucosa (53) (51) (53) (53) (53) (66) Gingival, Squamous Cell Carcinoma 1 (2%) 1 (2%) 2 (4%) 4 (8%) 1 (2%) Pancreas (53) (51) (53) (53) (53) (65) Carcinoma 1 (2%) Schwannoma Malignant, Metastatic, Uterus 1 (2%) Acinus, Adenoma 1 (2%) Salivary Glands (53) (51) (53) (52) (52) (66) Schwannoma Malignant, Metastatic, Skin 1 (2%) Stomach, Forestomach (53) (51) (53) (53) (53) (65) Squamous Cell Carcinoma 1 (2%) 1 (2%) Stomach, Glandular (53) (51) (53) (53) (53) (65) Carcinoma 1 (2%) Neuroendocrine Tumor, Malignant 1 (2%) ____________________________________________________________________________________________________________________________________ Page 2 NTP Experiment-Test: 96022-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC TEF EVALUATION (PCB MIXTURE;PCB 126/PCB 118) Date: 11/15/04 Route: GAVAGE Time: 11:12:15 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (53) (51) (53) (53) (53) (65) Schwannoma Benign 1 (2%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (53) (51) (53) (53) (53) (65) Adenoma 1 (2%) Carcinoma 1 (2%) Subcapsular, Adenoma 1 (2%) Adrenal Medulla (53) (51) (53) (53) (53) (64) Pheochromocytoma Malignant 1 (2%) Pheochromocytoma Benign 3 (6%) 3 (6%) 2 (4%) 1 (2%) Islets, Pancreatic (53) (51) (53) (53) (53) (65) Adenoma 1 (2%) Carcinoma 1 (2%) Pituitary Gland (53) (51) (52) (53) (53) (65) Pars Distalis, Adenoma 30 (57%) 11 (22%) 16 (31%) 10 (19%) Pars Distalis, Carcinoma 1 (2%) Pars Intermedia, Adenoma 1 (2%) Thyroid Gland (53) (51) (53) (52) (52) (66) Bilateral, C-Cell, Adenoma 1 (2%) 1 (2%) Bilateral, C-Cell, Carcinoma 1 (2%) C-Cell, Adenoma 8 (15%) 5 (10%) 7 (13%) 8 (15%) 4 (8%) 1 (2%) C-Cell, Carcinoma 3 (6%) 2 (4%) 2 (4%) Follicular Cell, Adenoma 2 (4%) 2 (4%) 1 (2%) Follicular Cell, Carcinoma 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Clitoral Gland (53) (51) (51) (52) (52) (66) Carcinoma 1 (2%) Ovary (53) (51) (53) (53) (53) (65) Granulosa Cell Tumor Malignant 1 (2%) Luteoma 1 (2%) Periovarian Tissue, Carcinoma, Metastatic, Page 3 NTP Experiment-Test: 96022-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC TEF EVALUATION (PCB MIXTURE;PCB 126/PCB 118) Date: 11/15/04 Route: GAVAGE Time: 11:12:15 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM - cont Pancreas 1 (2%) Uterus (53) (51) (53) (53) (53) (66) Carcinoma 1 (2%) 1 (2%) 1 (2%) Carcinoma, Metastatic, Pancreas 1 (2%) Fibrosarcoma 1 (2%) Hemangiosarcoma 1 (2%) Leiomyoma 1 (2%) Polyp Stromal 8 (15%) 4 (8%) 6 (11%) 8 (15%) 6 (11%) 3 (5%) Schwannoma Malignant 1 (2%) Schwannoma Malignant, Metastatic, Vagina 1 (2%) Squamous Cell Carcinoma 1 (2%) Bilateral, Polyp Stromal 3 (6%) 2 (4%) 1 (2%) 1 (2%) Cervix, Schwannoma Malignant 1 (2%) Cervix, Schwannoma Malignant, Metastatic, Vagina 1 (2%) Vagina (2) Schwannoma Malignant 1 (50%) Schwannoma Malignant, Metastatic, Skin 1 (50%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (53) (51) (53) (53) (53) (66) Lymph Node (28) (16) (16) (25) (20) (45) Pancreatic, Carcinoma, Metastatic, Stomach, Glandular 1 (4%) Lymph Node, Mandibular (53) (51) (53) (52) (52) (66) Schwannoma Malignant, Metastatic, Skin 1 (2%) Spleen (53) (51) (53) (53) (53) (65) Thymus (53) (51) (51) (51) (51) (59) Thymoma Benign 1 (2%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (53) (51) (53) (53) (53) (66) Adenolipoma 1 (2%) Adenoma 2 (4%) 1 (2%) Carcinoma 4 (8%) 1 (2%) 3 (6%) Carcinoma, Multiple 1 (2%) 1 (2%) Fibroadenoma 27 (51%) 23 (45%) 21 (40%) 14 (26%) 4 (8%) 6 (9%) Fibroadenoma, Multiple 15 (28%) 15 (29%) 15 (28%) 3 (6%) Skin (53) (51) (53) (53) (53) (66) Page 4 NTP Experiment-Test: 96022-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC TEF EVALUATION (PCB MIXTURE;PCB 126/PCB 118) Date: 11/15/04 Route: GAVAGE Time: 11:12:15 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM - cont Basal Cell Adenoma 1 (2%) Fibroma 1 (2%) 1 (2%) 1 (2%) 3 (6%) Fibrosarcoma 1 (2%) Schwannoma Malignant 1 (2%) 1 (2%) Squamous Cell Papilloma 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Skeletal Muscle (1) (1) Carcinoma, Metastatic, Pancreas 1 (100%) Schwannoma Malignant, Metastatic, Uterus 1 (100%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (53) (51) (53) (53) (53) (66) Carcinoma, Metastatic, Pituitary Gland 1 (2%) Carcinoma, Metastatic, Oral Mucosa 1 (2%) Medulloblastoma Mal 1 (2%) Cranial Nerve, Schwannoma Malignant 1 (2%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (53) (51) (53) (53) (53) (66) Carcinoma, Metastatic, Mammary Gland 1 (2%) 1 (2%) Carcinoma, Metastatic, Pancreas 1 (2%) Carcinoma, Metastatic, Thyroid Gland 1 (2%) Carcinoma, Metastatic, Uncertain Primary Site 1 (2%) Cystic Keratinizing Epithelioma 6 (11%) 1 (2%) 6 (9%) Cystic Keratinizing Epithelioma, Multiple 14 (26%) 48 (91%) 35 (53%) Nose (53) (51) (53) (53) (53) (66) Schwannoma Malignant, Metastatic, Brain 1 (2%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Harderian Gland (53) (51) (53) (53) (53) (66) Carcinoma, Metastatic, Oral Mucosa 1 (2%) ____________________________________________________________________________________________________________________________________ Page 5 NTP Experiment-Test: 96022-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC TEF EVALUATION (PCB MIXTURE;PCB 126/PCB 118) Date: 11/15/04 Route: GAVAGE Time: 11:12:15 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (53) (51) (53) (53) (53) (65) Carcinoma, Metastatic, Pancreas 1 (2%) Papilloma 1 (2%) Renal Tubule, Adenoma 1 (2%) Renal Tubule, Carcinoma 1 (2%) Urinary Bladder (53) (51) (53) (53) (52) (66) Schwannoma Malignant, Metastatic, Uterus 1 (2%) ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS Multiple Organs *(53) *(51) *(53) *(53) *(53) *(66) Adenolipoma 1 (2%) Leukemia Granulocytic 1 (2%) Leukemia Mononuclear 1 (2%) Lymphoma Malignant 1 (2%) ____________________________________________________________________________________________________________________________________ * Number of animals with any tissue examined microscopically Page 6 NTP Experiment-Test: 96022-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC TEF EVALUATION (PCB MIXTURE;PCB 126/PCB 118) Date: 11/15/04 Route: GAVAGE Time: 11:12:15 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG ____________________________________________________________________________________________________________________________________ TUMOR SUMMARY Total Animals with Primary Neoplasms (b) 53 47 51 42 51 45 Total Primary Neoplasms 126 80 96 102 115 73 Total Animals with Benign Neoplasms 53 43 47 40 51 45 Total Benign Neoplasms 107 68 76 74 85 59 Total Animals with Malignant Neoplasms 16 12 18 21 28 14 Total Malignant Neoplasms 19 12 20 27 30 14 Total Animals with Metastatic Neoplasms 1 5 6 1 Total Metastatic Neoplasm 1 8 13 1 Total Animals with Malignant Neoplasms 1 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: 96022-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC TEF EVALUATION (PCB MIXTURE;PCB 126/PCB 118) Date: 11/15/04 Route: GAVAGE Time: 11:12:15 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 360 NG TEQKG ST ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially in Study 50 Early Deaths Moribund Sacrifice 28 Natural Death 12 Survivors Terminal Sacrifice 10 Animals Examined Microscopically 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Colon (50) Intestine Large, Cecum (50) Intestine Small, Duodenum (50) Intestine Small, Jejunum (50) Intestine Small, Ileum (50) Liver (50) Cholangiocarcinoma 7 (14%) Cholangiocarcinoma, Multiple 12 (24%) Hepatocellular Adenoma 1 (2%) Hepatocholangioma 1 (2%) Oral Mucosa (50) Gingival, Squamous Cell Carcinoma 1 (2%) Pancreas (50) Salivary Glands (49) Stomach, Forestomach (50) Squamous Cell Papilloma 1 (2%) Stomach, Glandular (50) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Blood Vessel (50) Heart (50) ____________________________________________________________________________________________________________________________________ Page 8 NTP Experiment-Test: 96022-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC TEF EVALUATION (PCB MIXTURE;PCB 126/PCB 118) Date: 11/15/04 Route: GAVAGE Time: 11:12:15 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 360 NG TEQKG ST ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Thyroid Gland (49) C-Cell, Adenoma 4 (8%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Uterus (50) Polyp Stromal 7 (14%) Bilateral, Polyp Stromal 1 (2%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Lymph Node (22) Lymph Node, Mandibular (49) Lymph Node, Mesenteric (50) Spleen (50) Thymus (46) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (50) Carcinoma 1 (2%) Fibroadenoma 11 (22%) Fibroadenoma, Multiple 1 (2%) Skin (50) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM None ____________________________________________________________________________________________________________________________________ Page 9 NTP Experiment-Test: 96022-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC TEF EVALUATION (PCB MIXTURE;PCB 126/PCB 118) Date: 11/15/04 Route: GAVAGE Time: 11:12:15 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 360 NG TEQKG ST ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) Cranial Nerve, Squamous Cell Carcinoma, Metastatic, Oral Mucosa 1 (2%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) Cystic Keratinizing Epithelioma 7 (14%) Cystic Keratinizing Epithelioma, Multiple 5 (10%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM None ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) Urinary Bladder (50) ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS Multiple Organs *(50) Lymphoma Malignant 1 (2%) ____________________________________________________________________________________________________________________________________ * Number of animals with any tissue examined microscopically Page 10 NTP Experiment-Test: 96022-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC TEF EVALUATION (PCB MIXTURE;PCB 126/PCB 118) Date: 11/15/04 Route: GAVAGE Time: 11:12:15 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 360 NG TEQKG ST ____________________________________________________________________________________________________________________________________ TUMOR SUMMARY Total Animals with Primary Neoplasms (b) 36 Total Primary Neoplasms 61 Total Animals with Benign Neoplasms 28 Total Benign Neoplasms 39 Total Animals with Malignant Neoplasms 20 Total Malignant Neoplasms 22 Total Animals with Metastatic Neoplasms 1 Total Metastatic Neoplasm 1 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 ---------- ------------------------------------------------------------