TDMS Study 99035-01 Pathology Tables
NTP Experiment-Test: 99035-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: 26-39 WEEKS TRANSGENIC MODEL EVALUATION II (GLYCIDOL) Date: 03/31/04 Route: GAVAGE Time: 12:54:57 FINAL #1 Facility: Battelle Columbus Laboratory Chemical CAS #: 556-52-5 Lock Date: 09/24/01 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: 99035-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: 26-39 WEEKS TRANSGENIC MODEL EVALUATION II (GLYCIDOL) Date: 03/31/04 Route: GAVAGE Time: 12:54:57 ____________________________________________________________________________________________________________________________________ P16(INK4A)/(+/-) (C57BL/6) FEMALE 0 MG/KG 25 MG/KG 50 MG/KG 100 200 MG/KG MG/KG ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially in Study 15 15 15 15 15 Early Deaths Moribund Sacrifice 2 1 2 1 4 Natural Death 1 2 Survivors Terminal Sacrifice 13 14 12 14 9 Animals Examined Microscopically 15 15 15 15 15 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Colon (15) (15) (15) (15) (15) Histiocytic Sarcoma 1 (7%) Intestine Large, Rectum (15) (15) (15) (15) (15) Histiocytic Sarcoma 1 (7%) Intestine Small, Duodenum (15) (15) (15) (15) (15) Histiocytic Sarcoma 4 (27%) 1 (7%) 1 (7%) Intestine Small, Jejunum (15) (15) (15) (15) (15) Histiocytic Sarcoma 3 (20%) 3 (20%) 1 (7%) Intestine Small, Ileum (15) (15) (15) (15) (15) Histiocytic Sarcoma 2 (13%) 2 (13%) 1 (7%) 1 (7%) Liver (15) (15) (15) (15) (15) Histiocytic Sarcoma 5 (33%) 1 (7%) 8 (53%) 5 (33%) 8 (53%) Osteosarcoma, Metastatic, Uncertain Primary Site 1 (7%) Mesentery (2) Histiocytic Sarcoma 2 (100%) Stomach, Forestomach (15) (15) (15) (15) (15) Histiocytic Sarcoma 1 (7%) 1 (7%) Squamous Cell Papilloma 1 (7%) 3 (20%) Stomach, Glandular (15) (15) (15) (15) (15) Histiocytic Sarcoma 1 (7%) 1 (7%) 2 (13%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (15) (15) (15) (15) (15) Histiocytic Sarcoma 1 (7%) 2 (13%) 2 (13%) ____________________________________________________________________________________________________________________________________ Page 2 NTP Experiment-Test: 99035-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: 26-39 WEEKS TRANSGENIC MODEL EVALUATION II (GLYCIDOL) Date: 03/31/04 Route: GAVAGE Time: 12:54:57 ____________________________________________________________________________________________________________________________________ P16(INK4A)/(+/-) (C57BL/6) FEMALE 0 MG/KG 25 MG/KG 50 MG/KG 100 200 MG/KG MG/KG ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (15) (15) (15) (15) (15) Histiocytic Sarcoma 3 (20%) 7 (47%) 2 (13%) 1 (7%) Adrenal Medulla (15) (15) (15) (15) (15) Histiocytic Sarcoma 1 (7%) Pituitary Gland (15) (15) (15) (15) (15) Histiocytic Sarcoma 1 (7%) 2 (13%) 1 (7%) 1 (7%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Ovary (15) (15) (15) (15) (15) Histiocytic Sarcoma 8 (53%) 5 (33%) 8 (53%) 6 (40%) 5 (33%) Osteosarcoma, Metastatic, Uncertain Primary Site 1 (7%) Uterus (15) (15) (15) (15) (15) Hemangiosarcoma, Metastatic, Spleen 1 (7%) Histiocytic Sarcoma 4 (27%) 4 (27%) 5 (33%) Sarcoma Stromal 1 (7%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (15) (15) (15) (15) (15) Hemangiosarcoma 1 (7%) Histiocytic Sarcoma 9 (60%) 8 (53%) 11 (73%) 8 (53%) 8 (53%) Lymph Node (13) (15) (15) (13) (14) Lumbar, Histiocytic Sarcoma 2 (13%) 1 (7%) 2 (14%) Mediastinal, Histiocytic Sarcoma 1 (8%) 1 (7%) 6 (40%) 3 (23%) 3 (21%) Pancreatic, Histiocytic Sarcoma 1 (7%) Renal, Histiocytic Sarcoma 2 (13%) 1 (7%) Lymph Node, Mandibular (15) (15) (15) (15) (15) Histiocytic Sarcoma 1 (7%) 1 (7%) 6 (40%) 2 (13%) 3 (20%) Lymph Node, Mesenteric (15) (15) (15) (15) (15) Histiocytic Sarcoma 3 (20%) 3 (20%) 5 (33%) 3 (20%) 5 (33%) Spleen (15) (15) (15) (15) (15) Hemangiosarcoma 1 (7%) Histiocytic Sarcoma 2 (13%) 2 (13%) 7 (47%) 3 (20%) 2 (13%) Page 3 NTP Experiment-Test: 99035-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: 26-39 WEEKS TRANSGENIC MODEL EVALUATION II (GLYCIDOL) Date: 03/31/04 Route: GAVAGE Time: 12:54:57 ____________________________________________________________________________________________________________________________________ P16(INK4A)/(+/-) (C57BL/6) FEMALE 0 MG/KG 25 MG/KG 50 MG/KG 100 200 MG/KG MG/KG ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - cont Thymus (15) (15) (15) (15) (15) Histiocytic Sarcoma 1 (7%) 1 (7%) 6 (40%) 2 (13%) 2 (13%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Skin (15) (15) (15) (15) (15) Subcutaneous Tissue, Hemangiosarcoma 1 (7%) Subcutaneous Tissue, Histiocytic Sarcoma 2 (13%) 1 (7%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Skeletal Muscle (2) Histiocytic Sarcoma 2 (100%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (15) (15) (15) (15) (15) Choristoma 1 (7%) Histiocytic Sarcoma 1 (7%) 4 (27%) 4 (27%) 2 (13%) Spinal Cord (1) Histiocytic Sarcoma 1 (100%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (15) (15) (15) (15) (15) Alveolar/Bronchiolar Adenoma 1 (7%) 1 (7%) 4 (27%) Alveolar/Bronchiolar Carcinoma 1 (7%) Histiocytic Sarcoma 2 (13%) 6 (40%) 3 (20%) 6 (40%) Osteosarcoma, Metastatic, Uncertain Primary Site 1 (7%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Zymbal's Gland (1) (1) Squamous Cell Carcinoma 1 (100%) ____________________________________________________________________________________________________________________________________ Page 4 NTP Experiment-Test: 99035-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: 26-39 WEEKS TRANSGENIC MODEL EVALUATION II (GLYCIDOL) Date: 03/31/04 Route: GAVAGE Time: 12:54:57 ____________________________________________________________________________________________________________________________________ P16(INK4A)/(+/-) (C57BL/6) FEMALE 0 MG/KG 25 MG/KG 50 MG/KG 100 200 MG/KG MG/KG ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (15) (15) (15) (15) (15) Histiocytic Sarcoma 1 (7%) 4 (27%) 2 (13%) 3 (20%) Urinary Bladder (15) (15) (15) (15) (15) Histiocytic Sarcoma 2 (13%) 2 (13%) 2 (13%) ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS Multiple Organs *(15) *(15) *(15) *(15) *(15) Histiocytic Sarcoma 9 (60%) 9 (60%) 12 (80%) 10 (67%) 13 (87%) ____________________________________________________________________________________________________________________________________ * Number of animals with any tissue examined microscopically Page 5 NTP Experiment-Test: 99035-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: 26-39 WEEKS TRANSGENIC MODEL EVALUATION II (GLYCIDOL) Date: 03/31/04 Route: GAVAGE Time: 12:54:57 ____________________________________________________________________________________________________________________________________ P16(INK4A)/(+/-) (C57BL/6) FEMALE 0 MG/KG 25 MG/KG 50 MG/KG 100 200 MG/KG MG/KG ____________________________________________________________________________________________________________________________________ TUMOR SUMMARY Total Animals with Primary Neoplasms (b) 10 9 12 12 14 Total Primary Neoplasms 10 10 13 14 23 Total Animals with Benign Neoplasms 1 2 7 Total Benign Neoplasms 1 2 7 Total Animals with Malignant Neoplasms 10 9 12 11 14 Total Malignant Neoplasms 10 9 13 12 15 Total Animals with Metastatic Neoplasms 1 1 Total Metastatic Neoplasm 3 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 6 NTP Experiment-Test: 99035-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: 26-39 WEEKS TRANSGENIC MODEL EVALUATION II (GLYCIDOL) Date: 03/31/04 Route: GAVAGE Time: 12:54:57 ____________________________________________________________________________________________________________________________________ P16(INK4A)/(+/-) (C57BL/6) MALE 0 MG/KG 25 MG/KG 50 MG/KG 100 200 MG/KG MG/KG ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially in Study 15 15 15 15 15 Early Deaths Natural Death 2 1 1 1 3 Moribund Sacrifice 1 4 Dosing Accident 1 Survivors Terminal Sacrifice 13 14 13 14 7 Animals Examined Microscopically 15 15 15 15 15 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Rectum (15) (15) (15) (15) (15) Histiocytic Sarcoma 1 (7%) 1 (7%) Intestine Large, Cecum (15) (15) (15) (15) (15) Histiocytic Sarcoma 1 (7%) Intestine Small, Duodenum (15) (15) (15) (15) (15) Histiocytic Sarcoma 1 (7%) 2 (13%) Intestine Small, Jejunum (15) (15) (15) (15) (15) Histiocytic Sarcoma 2 (13%) 1 (7%) Intestine Small, Ileum (15) (15) (15) (15) (15) Histiocytic Sarcoma 1 (7%) Liver (15) (15) (15) (15) (15) Histiocytic Sarcoma 2 (13%) 2 (13%) 4 (27%) 2 (13%) 10 (67%) Pancreas (1) Histiocytic Sarcoma 1 (100%) Stomach, Forestomach (15) (15) (15) (15) (15) Squamous Cell Papilloma, Multiple 1 (7%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (15) (15) (15) (15) (15) Histiocytic Sarcoma 1 (7%) 5 (33%) ____________________________________________________________________________________________________________________________________ Page 7 NTP Experiment-Test: 99035-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: 26-39 WEEKS TRANSGENIC MODEL EVALUATION II (GLYCIDOL) Date: 03/31/04 Route: GAVAGE Time: 12:54:57 ____________________________________________________________________________________________________________________________________ P16(INK4A)/(+/-) (C57BL/6) MALE 0 MG/KG 25 MG/KG 50 MG/KG 100 200 MG/KG MG/KG ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (15) (15) (15) (14) (15) Histiocytic Sarcoma 1 (7%) 1 (7%) Pituitary Gland (15) (15) (14) (15) (15) Histiocytic Sarcoma 1 (7%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Epididymis (15) (15) (15) (15) (15) Histiocytic Sarcoma 2 (13%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (15) (15) (15) (15) (15) Histiocytic Sarcoma 2 (13%) 5 (33%) 6 (40%) 4 (27%) 8 (53%) Lymph Node (14) (14) (15) (13) (13) Mediastinal, Histiocytic Sarcoma 1 (7%) 3 (20%) 7 (54%) Mediastinal, Osteosarcoma, Metastatic, Skin 1 (7%) Lymph Node, Mandibular (15) (15) (15) (15) (15) Histiocytic Sarcoma 1 (7%) 1 (7%) 2 (13%) 3 (20%) Lymph Node, Mesenteric (15) (15) (15) (14) (15) Histiocytic Sarcoma 1 (7%) 2 (13%) 1 (7%) 5 (33%) Spleen (15) (15) (15) (15) (15) Histiocytic Sarcoma 1 (7%) 1 (7%) 3 (20%) 1 (7%) 7 (47%) Thymus (15) (15) (15) (15) (15) Histiocytic Sarcoma 1 (7%) 2 (13%) 2 (13%) 4 (27%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Skin (15) (15) (15) (15) (15) Osteosarcoma 1 (7%) Squamous Cell Papilloma 1 (7%) ____________________________________________________________________________________________________________________________________ Page 8 NTP Experiment-Test: 99035-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: 26-39 WEEKS TRANSGENIC MODEL EVALUATION II (GLYCIDOL) Date: 03/31/04 Route: GAVAGE Time: 12:54:57 ____________________________________________________________________________________________________________________________________ P16(INK4A)/(+/-) (C57BL/6) MALE 0 MG/KG 25 MG/KG 50 MG/KG 100 200 MG/KG MG/KG ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Skeletal Muscle (1) Hemangiosarcoma 1 (100%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (15) (15) (15) (15) (15) Histiocytic Sarcoma 1 (7%) 1 (7%) 1 (7%) 4 (27%) Spinal Cord (1) Histiocytic Sarcoma 1 (100%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (15) (15) (15) (15) (15) Alveolar/Bronchiolar Adenoma 1 (7%) 2 (13%) 5 (33%) 2 (13%) Alveolar/Bronchiolar Adenoma, Multiple 2 (13%) 1 (7%) Alveolar/Bronchiolar Carcinoma 2 (13%) 1 (7%) 3 (20%) Alveolar/Bronchiolar Carcinoma, Multiple 1 (7%) Histiocytic Sarcoma 1 (7%) 1 (7%) 2 (13%) 2 (13%) 6 (40%) Osteosarcoma, Metastatic, Skin 1 (7%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Harderian Gland (1) Adenoma 1 (100%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (15) (15) (15) (15) (15) Histiocytic Sarcoma 1 (7%) 2 (13%) 2 (13%) 5 (33%) ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS Multiple Organs *(15) *(15) *(15) *(15) *(15) Histiocytic Sarcoma 2 (13%) 6 (40%) 9 (60%) 5 (33%) 11 (73%) Lymphoma Malignant 2 (13%) 1 (7%) * Number of animals with any tissue examined microscopically Page 9 NTP Experiment-Test: 99035-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: 26-39 WEEKS TRANSGENIC MODEL EVALUATION II (GLYCIDOL) Date: 03/31/04 Route: GAVAGE Time: 12:54:57 ____________________________________________________________________________________________________________________________________ P16(INK4A)/(+/-) (C57BL/6) MALE 0 MG/KG 25 MG/KG 50 MG/KG 100 200 MG/KG MG/KG ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS - cont Multiple Organs *(15) *(15) *(15) *(15) *(15) ____________________________________________________________________________________________________________________________________ Page 10 NTP Experiment-Test: 99035-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: 26-39 WEEKS TRANSGENIC MODEL EVALUATION II (GLYCIDOL) Date: 03/31/04 Route: GAVAGE Time: 12:54:57 ____________________________________________________________________________________________________________________________________ P16(INK4A)/(+/-) (C57BL/6) MALE 0 MG/KG 25 MG/KG 50 MG/KG 100 200 MG/KG MG/KG ____________________________________________________________________________________________________________________________________ TUMOR SUMMARY Total Animals with Primary Neoplasms (b) 7 8 12 12 12 Total Primary Neoplasms 8 9 12 17 15 Total Animals with Benign Neoplasms 1 2 2 7 4 Total Benign Neoplasms 1 2 2 7 4 Total Animals with Malignant Neoplasms 6 7 10 9 11 Total Malignant Neoplasms 7 7 10 10 11 Total Animals with Metastatic Neoplasms 1 Total Metastatic Neoplasm 2 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 ---------- ------------------------------------------------------------