TDMS Study 96021-01 Pathology Tables
NTP Experiment-Test: 96021-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION (PCB 153) Date: 12/15/03 Route: GAVAGE Time: 11:03:02 FINAL#4 RATS Facility: Battelle Columbus Laboratory Chemical CAS #: 35065-27-1 Lock Date: 01/16/02 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: 96021-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION (PCB 153) Date: 12/15/03 Route: GAVAGE Time: 11:03:02 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 0 UG/KG 10 UG/KG 100 300 1000 3000 UG/KG UG/KG UG/KG UG/KG ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially in Study 98 86 98 98 98 80 Early Deaths Natural Death 11 15 8 9 15 11 Moribund Sacrifice 18 23 17 22 18 19 Dosing Accident 1 Survivors Terminal Sacrifice 24 16 28 20 20 21 Natural Death 1 Animals Examined Microscopically 53 54 53 53 53 51 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Colon (53) (54) (53) (53) (53) (50) Intestine Large, Rectum (53) (54) (53) (53) (53) (50) Intestine Large, Cecum (53) (54) (53) (53) (53) (50) Leiomyoma 1 (2%) Intestine Small, Duodenum (53) (54) (53) (53) (53) (51) Intestine Small, Jejunum (53) (54) (53) (53) (53) (50) Liver (53) (54) (53) (53) (53) (51) Carcinoma, Metastatic, Uterus 1 (2%) Cholangioma 2 (4%) Hepatocellular Adenoma 1 (2%) Histiocytic Sarcoma 1 (2%) Mesentery (1) (1) Carcinoma, Metastatic, Uterus 1 (100%) Oral Mucosa (21) (12) (16) (12) (16) (25) Gingival, Squamous Cell Carcinoma 2 (17%) 1 (8%) 1 (4%) Pancreas (53) (54) (53) (53) (53) (51) Salivary Glands (51) (52) (53) (52) (53) (51) Stomach, Forestomach (53) (54) (53) (53) (53) (51) Histiocytic Sarcoma 1 (2%) Stomach, Glandular (53) (54) (53) (53) (53) (51) Histiocytic Sarcoma 1 (2%) Tooth (34) (13) (19) (22) (23) (35) Peridontal Tissue, Neurofibrosarcoma 1 (3%) ____________________________________________________________________________________________________________________________________ Page 2 NTP Experiment-Test: 96021-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION (PCB 153) Date: 12/15/03 Route: GAVAGE Time: 11:03:02 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 0 UG/KG 10 UG/KG 100 300 1000 3000 UG/KG UG/KG UG/KG UG/KG ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Blood Vessel (52) (54) (53) (53) (53) (51) Aorta, Hemangiosarcoma, Metastatic, Heart 1 (2%) Heart (52) (54) (53) (53) (53) (51) Hemangiosarcoma 1 (2%) Histiocytic Sarcoma 1 (2%) Schwannoma Malignant 1 (2%) 1 (2%) 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (53) (54) (53) (53) (53) (51) Adenoma 1 (2%) Adrenal Medulla (53) (54) (53) (53) (53) (51) Pheochromocytoma Malignant 1 (2%) 1 (2%) Pheochromocytoma Benign 2 (4%) 1 (2%) 4 (8%) 4 (8%) 2 (4%) 2 (4%) Bilateral, Pheochromocytoma Benign 1 (2%) Islets, Pancreatic (53) (54) (53) (53) (53) (51) Adenoma 1 (2%) Carcinoma 1 (2%) Parathyroid Gland (49) (46) (50) (47) (46) (48) Adenoma 2 (4%) Pituitary Gland (53) (54) (53) (53) (53) (50) Carcinoma, Metastatic, Oral Mucosa 1 (2%) Neurofibrosarcoma, Metastatic, Tooth 1 (2%) Pars Distalis, Adenoma 18 (34%) 19 (35%) 19 (36%) 19 (36%) 24 (45%) 11 (22%) Pars Distalis, Carcinoma 1 (2%) Thyroid Gland (51) (52) (53) (53) (53) (51) Bilateral, C-Cell, Adenoma 2 (4%) 4 (8%) 5 (9%) C-Cell, Adenoma 14 (27%) 9 (17%) 17 (32%) 11 (21%) 17 (32%) 6 (12%) C-Cell, Adenoma, Multiple 1 (2%) 1 (2%) C-Cell, Carcinoma 2 (4%) 2 (4%) 1 (2%) 1 (2%) 2 (4%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ Page 3 NTP Experiment-Test: 96021-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION (PCB 153) Date: 12/15/03 Route: GAVAGE Time: 11:03:02 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 0 UG/KG 10 UG/KG 100 300 1000 3000 UG/KG UG/KG UG/KG UG/KG ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Clitoral Gland (53) (51) (52) (53) (51) (50) Carcinoma 1 (2%) Carcinoma, Metastatic, Mammary Gland 1 (2%) Ovary (53) (53) (53) (53) (53) (50) Cystadenoma 1 (2%) Granulosa Cell Tumor Malignant 1 (2%) Granulosa Cell Tumor Benign 1 (2%) Granulosa-Theca Tumor Benign 1 (2%) Schwannoma Malignant 1 (2%) Uterus (53) (54) (53) (53) (53) (50) Carcinoma 1 (2%) 1 (2%) 1 (2%) Leiomyosarcoma 3 (6%) Polyp Stromal 6 (11%) 9 (17%) 4 (8%) 6 (11%) 3 (6%) 2 (4%) Polyp Stromal, Multiple 1 (2%) Schwannoma Malignant 1 (2%) 1 (2%) Squamous Cell Carcinoma 2 (4%) Cervix, Carcinoma 1 (2%) Cervix, Schwannoma Malignant 1 (2%) Cervix, Schwannoma Malignant, Metastatic, Vagina 1 (2%) Cervix, Squamous Cell Carcinoma 1 (2%) Vagina (1) (3) (2) (1) (1) (3) Fibrosarcoma 2 (67%) Fibrous Histiocytoma, Metastatic, Skin 1 (100%) Sarcoma 1 (33%) Schwannoma Malignant 1 (100%) 3 (100%) Squamous Cell Carcinoma 1 (50%) 1 (100%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (53) (54) (53) (53) (53) (51) Histiocytic Sarcoma 1 (2%) Lipoma 1 (2%) Lymph Node (3) (3) (3) (2) (5) (6) Deep Cervical, Carcinoma, Metastatic, Thyroid Gland 1 (20%) Mediastinal, Carcinoma, Metastatic, Uterus 1 (20%) Mediastinal, Histiocytic Sarcoma 1 (50%) Lymph Node, Mandibular (51) (52) (53) (51) (53) (51) Lymph Node, Mesenteric (52) (54) (53) (53) (53) (51) Carcinoma, Metastatic, Uterus 1 (2%) Page 4 NTP Experiment-Test: 96021-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION (PCB 153) Date: 12/15/03 Route: GAVAGE Time: 11:03:02 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 0 UG/KG 10 UG/KG 100 300 1000 3000 UG/KG UG/KG UG/KG UG/KG ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - cont Histiocytic Sarcoma 1 (2%) Spleen (53) (54) (53) (53) (53) (51) Histiocytic Sarcoma 1 (2%) Thymus (48) (53) (52) (53) (53) (47) Hemangiosarcoma, Metastatic, Heart 1 (2%) Histiocytic Sarcoma 1 (2%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (53) (54) (53) (53) (53) (51) Adenoma 1 (2%) 1 (2%) 1 (2%) 3 (6%) 2 (4%) Adenoma, Multiple 1 (2%) Carcinoma 8 (15%) 6 (11%) 7 (13%) 4 (8%) 6 (11%) 2 (4%) Carcinoma, Multiple 1 (2%) Fibroadenoma 22 (42%) 21 (39%) 22 (42%) 22 (42%) 27 (51%) 24 (47%) Fibroadenoma, Multiple 19 (36%) 13 (24%) 14 (26%) 13 (25%) 12 (23%) 8 (16%) Skin (53) (54) (53) (53) (53) (51) Basal Cell Adenoma 1 (2%) Basal Cell Carcinoma 1 (2%) 1 (2%) Fibroma 2 (4%) 1 (2%) 1 (2%) Fibrosarcoma 1 (2%) 1 (2%) Fibrous Histiocytoma 1 (2%) 1 (2%) Histiocytic Sarcoma 1 (2%) Keratoacanthoma 1 (2%) 1 (2%) Lipoma 1 (2%) Sarcoma 1 (2%) Schwannoma Malignant 1 (2%) Schwannoma Malignant, Metastatic, Vagina 1 (2%) Squamous Cell Papilloma 1 (2%) Subcutaneous Tissue, Sarcoma 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM None ____________________________________________________________________________________________________________________________________ Page 5 NTP Experiment-Test: 96021-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION (PCB 153) Date: 12/15/03 Route: GAVAGE Time: 11:03:02 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 0 UG/KG 10 UG/KG 100 300 1000 3000 UG/KG UG/KG UG/KG UG/KG ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (53) (54) (53) (53) (53) (51) Astrocytoma Malignant 1 (2%) Carcinoma, Metastatic, Pituitary Gland 1 (2%) Carcinoma, Metastatic, Oral Mucosa 1 (2%) Neurofibrosarcoma, Metastatic, Tooth 1 (2%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (52) (54) (53) (53) (53) (51) Alveolar/Bronchiolar Adenoma 1 (2%) 2 (4%) Basal Cell Carcinoma, Metastatic, Skin 1 (2%) Carcinoma, Metastatic, Mammary Gland 1 (2%) 1 (2%) 1 (2%) Carcinoma, Metastatic, Uterus 1 (2%) Carcinoma, Metastatic, Oral Mucosa 1 (2%) Fibrous Histiocytoma, Metastatic, Skin 1 (2%) Histiocytic Sarcoma 1 (2%) Mediastinum, Hemangiosarcoma, Metastatic, Heart 1 (2%) Nose (53) (54) (53) (53) (53) (51) Trachea (52) (54) (53) (53) (53) (51) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (53) (54) (53) (53) (52) (51) Neurofibrosarcoma, Metastatic, Tooth 1 (2%) Harderian Gland (53) (54) (53) (53) (53) (49) Carcinoma, Metastatic, Oral Mucosa 1 (2%) Neurofibrosarcoma, Metastatic, Tooth 1 (2%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (53) (54) (53) (53) (53) (51) Carcinoma, Metastatic, Mammary Gland 1 (2%) Histiocytic Sarcoma 1 (2%) Nephroblastoma 1 (2%) Stromal Nephroma 1 (2%) 1 (2%) Bilateral, Renal Tubule, Carcinoma 1 (2%) Renal Tubule, Adenoma 1 (2%) Urinary Bladder (53) (53) (53) (53) (53) (50) Page 6 NTP Experiment-Test: 96021-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION (PCB 153) Date: 12/15/03 Route: GAVAGE Time: 11:03:02 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 0 UG/KG 10 UG/KG 100 300 1000 3000 UG/KG UG/KG UG/KG UG/KG ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS Multiple Organs *(53) *(54) *(53) *(53) *(53) *(51) Histiocytic Sarcoma 1 (2%) Leukemia Mononuclear 1 (2%) Lymphoma Malignant 2 (4%) 3 (6%) ____________________________________________________________________________________________________________________________________ * Number of animals with any tissue examined microscopically Page 7 NTP Experiment-Test: 96021-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION (PCB 153) Date: 12/15/03 Route: GAVAGE Time: 11:03:02 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 0 UG/KG 10 UG/KG 100 300 1000 3000 UG/KG UG/KG UG/KG UG/KG ____________________________________________________________________________________________________________________________________ TUMOR SUMMARY Total Animals with Primary Neoplasms (b) 52 51 49 48 51 48 Total Primary Neoplasms 108 100 105 97 117 70 Total Animals with Benign Neoplasms 50 41 45 46 49 40 Total Benign Neoplasms 91 77 87 80 102 58 Total Animals with Malignant Neoplasms 12 20 16 14 14 11 Total Malignant Neoplasms 17 23 18 17 15 12 Total Animals with Metastatic Neoplasms 3 2 2 4 4 Total Metastatic Neoplasm 8 5 2 8 5 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 8 NTP Experiment-Test: 96021-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION (PCB 153) Date: 12/15/03 Route: GAVAGE Time: 11:03:02 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 3000 UG/ KG STOP ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially in Study 50 Early Deaths Natural Death 14 Moribund Sacrifice 16 Survivors Terminal Sacrifice 20 Animals Examined Microscopically 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Small, Jejunum (49) Fibrosarcoma 1 (2%) Liver (50) Cholangioma 1 (2%) Cholangioma, Multiple 1 (2%) Pancreas (50) Acinus, Adenoma 1 (2%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (50) Fibrous Histiocytoma, Metastatic, Skin 1 (2%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Medulla (50) Pheochromocytoma Benign 6 (12%) Islets, Pancreatic (50) Adenoma 1 (2%) Carcinoma 1 (2%) Parathyroid Gland (45) Adenoma 1 (2%) Pituitary Gland (50) Pars Distalis, Adenoma 23 (46%) Pars Distalis, Carcinoma 1 (2%) Thyroid Gland (49) C-Cell, Adenoma 18 (37%) Page 9 NTP Experiment-Test: 96021-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION (PCB 153) Date: 12/15/03 Route: GAVAGE Time: 11:03:02 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 3000 UG/ KG STOP ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM - cont C-Cell, Carcinoma 3 (6%) Follicular Cell, Adenoma 2 (4%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Ovary (49) Cystadenoma 1 (2%) Granulosa-Theca Tumor Benign 1 (2%) Uterus (49) Carcinoma 1 (2%) Polyp Stromal 4 (8%) Cervix, Schwannoma Malignant 1 (2%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM None ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (50) Carcinoma 10 (20%) Fibroadenoma 16 (32%) Fibroadenoma, Multiple 14 (28%) Skin (50) Basal Cell Carcinoma 1 (2%) Fibroma 2 (4%) Fibrosarcoma 4 (8%) Fibrous Histiocytoma 1 (2%) Schwannoma Malignant 1 (2%) ____________________________________________________________________________________________________________________________________ Page 10 NTP Experiment-Test: 96021-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION (PCB 153) Date: 12/15/03 Route: GAVAGE Time: 11:03:02 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 3000 UG/ KG STOP ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (50) Schwannoma Malignant, Metastatic, Skin 1 (2%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) Carcinoma, Metastatic, Pituitary Gland 1 (2%) Meninges, Sarcoma 1 (2%) Meninges, Schwannoma Malignant, Metastatic, Skin 1 (2%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) Carcinoma, Metastatic, Mammary Gland 1 (2%) Fibrous Histiocytoma, Metastatic, Skin 1 (2%) Nose (50) Basal Cell Carcinoma, Metastatic, Skin 1 (2%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (50) Optic Nerve, Schwannoma Malignant, Metastatic, Skin 1 (2%) Harderian Gland (50) Schwannoma Malignant, Metastatic, Skin 1 (2%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) Fibrous Histiocytoma, Metastatic, Skin 1 (2%) Stromal Nephroma 1 (2%) Page 11 NTP Experiment-Test: 96021-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION (PCB 153) Date: 12/15/03 Route: GAVAGE Time: 11:03:02 ____________________________________________________________________________________________________________________________________ SPRAGUE-DAWLEY RATS FEMALE 3000 UG/ KG STOP ____________________________________________________________________________________________________________________________________ TUMOR SUMMARY Total Animals with Primary Neoplasms (b) 49 Total Primary Neoplasms 119 Total Animals with Benign Neoplasms 44 Total Benign Neoplasms 92 Total Animals with Malignant Neoplasms 23 Total Malignant Neoplasms 27 Total Animals with Metastatic Neoplasms 5 Total Metastatic Neoplasm 10 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 ---------- ------------------------------------------------------------