TDMS Study 93020-07 Pathology Tables
NTP Experiment-Test: 93020-07 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC DIISOPROPYLCARBODIIMIDE Date: 06/30/04 Route: SKIN APPLICATION Time: 11:19:18 FINAL #1 RATS Facility: Southern Research Institute Chemical CAS #: 693-13-0 Lock Date: 03/14/03 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: 93020-07 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC DIISOPROPYLCARBODIIMIDE Date: 06/30/04 Route: SKIN APPLICATION Time: 11:19:18 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially in Study 50 50 50 50 Early Deaths Moribund Sacrifice 13 9 10 14 Natural Death 7 9 8 10 Survivors Terminal Sacrifice 30 32 32 25 Other 1 Animals Examined Microscopically 50 50 50 49 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Colon (50) (50) (49) (49) Intestine Large, Cecum (50) (50) (50) (49) Intestine Small, Duodenum (49) (50) (50) (49) Leiomyoma 1 (2%) Intestine Small, Jejunum (47) (50) (50) (46) Intestine Small, Ileum (48) (49) (50) (49) Liver (50) (50) (50) (49) Carcinoma, Metastatic, Thyroid Gland 1 (2%) Hepatocellular Adenoma 6 (12%) 1 (2%) 2 (4%) 1 (2%) Mesentery (11) (12) (9) (9) Fibrosarcoma 1 (11%) Oral Mucosa (1) (2) Squamous Cell Carcinoma 1 (100%) 1 (50%) Pancreas (50) (50) (50) (49) Salivary Glands (50) (50) (50) (48) Stomach, Forestomach (50) (50) (50) (49) Squamous Cell Papilloma 1 (2%) Stomach, Glandular (50) (50) (50) (49) Tongue (2) (1) Squamous Cell Papilloma 2 (100%) 1 (100%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (50) (50) (50) (49) Carcinoma, Metastatic, Thyroid Gland 1 (2%) Schwannoma Malignant 1 (2%) ____________________________________________________________________________________________________________________________________ Page 2 NTP Experiment-Test: 93020-07 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC DIISOPROPYLCARBODIIMIDE Date: 06/30/04 Route: SKIN APPLICATION Time: 11:19:18 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (50) (50) (50) (49) Adenoma 3 (6%) 1 (2%) Adrenal Medulla (49) (50) (50) (49) Pheochromocytoma Malignant 1 (2%) Pheochromocytoma Benign 1 (2%) 1 (2%) 1 (2%) Islets, Pancreatic (50) (50) (50) (49) Adenoma 2 (4%) Pituitary Gland (50) (50) (50) (49) Pars Distalis, Adenoma 28 (56%) 32 (64%) 30 (60%) 24 (49%) Pars Distalis, Adenoma, Multiple 5 (10%) 2 (4%) 3 (6%) 3 (6%) Pars Distalis, Carcinoma 3 (6%) 1 (2%) 1 (2%) 4 (8%) Pars Intermedia, Adenoma 1 (2%) Thyroid Gland (50) (50) (50) (49) C-Cell, Adenoma 3 (6%) 2 (4%) 6 (12%) 6 (12%) C-Cell, Carcinoma 2 (4%) 2 (4%) 3 (6%) Follicular Cell, Adenoma 2 (4%) Follicular Cell, Carcinoma 1 (2%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Clitoral Gland (50) (49) (50) (49) Adenoma 2 (4%) 3 (6%) 5 (10%) 2 (4%) Carcinoma 2 (4%) 6 (12%) 2 (4%) Carcinoma, Multiple 1 (2%) Ovary (50) (50) (50) (49) Uterus (50) (50) (50) (49) Carcinoma 2 (4%) Leiomyoma 1 (2%) 1 (2%) Polyp Stromal 10 (20%) 10 (20%) 9 (18%) 9 (18%) Polyp Stromal, Multiple 1 (2%) 1 (2%) Sarcoma 1 (2%) Vagina (6) (6) (5) (11) Granular Cell Tumor Benign 1 (17%) ____________________________________________________________________________________________________________________________________ Page 3 NTP Experiment-Test: 93020-07 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC DIISOPROPYLCARBODIIMIDE Date: 06/30/04 Route: SKIN APPLICATION Time: 11:19:18 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (50) (50) (50) (49) Lymph Node (13) (10) (14) (8) Deep Cervical, Carcinoma, Metastatic, Thyroid Gland 1 (8%) 1 (13%) Mediastinal, Carcinoma, Metastatic, Thyroid Gland 1 (8%) 1 (13%) Renal, Carcinoma, Metastatic, Thyroid Gland 1 (13%) Lymph Node, Mandibular (3) (7) (1) (2) Lymph Node, Mesenteric (50) (50) (50) (48) Spleen (50) (50) (50) (49) Thymus (50) (48) (49) (46) Carcinoma, Metastatic, Thyroid Gland 1 (2%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (50) (50) (50) (48) Adenoma 1 (2%) 1 (2%) 1 (2%) Carcinoma 4 (8%) 2 (4%) Fibroadenoma 10 (20%) 9 (18%) 20 (40%) 13 (27%) Fibroadenoma, Multiple 2 (4%) 2 (4%) 1 (2%) 3 (6%) Skin (50) (50) (50) (49) Keratoacanthoma 1 (2%) Sebaceous Gland, Adenoma 1 (2%) Subcutaneous Tissue, Fibroma 1 (2%) 3 (6%) Subcutaneous Tissue, Fibrosarcoma 2 (4%) Subcutaneous Tissue, Schwannoma Malignant 2 (4%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM None ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (50) (50) (49) Carcinoma, Metastatic, Pituitary Gland 3 (6%) 2 (4%) Glioma Malignant, Mixed Cell 2 (4%) 1 (2%) Granular Cell Tumor Benign 1 (2%) ____________________________________________________________________________________________________________________________________ Page 4 NTP Experiment-Test: 93020-07 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC DIISOPROPYLCARBODIIMIDE Date: 06/30/04 Route: SKIN APPLICATION Time: 11:19:18 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (50) (50) (49) Alveolar/Bronchiolar Adenoma 1 (2%) Carcinoma, Metastatic, Thyroid Gland 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (50) (50) (50) (49) Iris, Amelanotic Melanoma, Benign 1 (2%) Harderian Gland (50) (50) (50) (49) Adenoma 1 (2%) Zymbal's Gland (1) Carcinoma 1 (100%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (50) (50) (49) Renal Tubule, Adenoma 1 (2%) Urinary Bladder (50) (50) (50) (49) Papilloma 1 (2%) ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS Multiple Organs *(50) *(50) *(50) *(49) Leukemia Mononuclear 9 (18%) 9 (18%) 7 (14%) 15 (31%) ____________________________________________________________________________________________________________________________________ * Number of animals with any tissue examined microscopically Page 5 NTP Experiment-Test: 93020-07 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC DIISOPROPYLCARBODIIMIDE Date: 06/30/04 Route: SKIN APPLICATION Time: 11:19:18 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG ____________________________________________________________________________________________________________________________________ TUMOR SUMMARY Total Animals with Primary Neoplasms (b) 48 45 44 45 Total Primary Neoplasms 99 89 100 103 Total Animals with Benign Neoplasms 44 41 41 39 Total Benign Neoplasms 74 70 83 74 Total Animals with Malignant Neoplasms 22 14 16 23 Total Malignant Neoplasms 25 19 17 29 Total Animals with Metastatic Neoplasms 4 3 Total Metastatic Neoplasm 6 9 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 6 NTP Experiment-Test: 93020-07 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC DIISOPROPYLCARBODIIMIDE Date: 06/30/04 Route: SKIN APPLICATION Time: 11:19:18 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially in Study 50 50 50 50 Early Deaths Natural Death 12 8 8 10 Moribund Sacrifice 18 12 10 23 Survivors Terminal Sacrifice 20 30 32 17 Animals Examined Microscopically 50 50 50 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Colon (50) (50) (50) (50) Adenoma 1 (2%) Carcinoma 1 (2%) Schwannoma Malignant, Metastatic, Mesentery 1 (2%) Intestine Large, Cecum (50) (50) (50) (49) Intestine Small, Duodenum (49) (49) (49) (49) Schwannoma Malignant, Metastatic, Mesentery 1 (2%) Intestine Small, Jejunum (49) (49) (48) (49) Intestine Small, Ileum (49) (49) (50) (48) Liver (50) (50) (50) (50) Hepatocellular Adenoma 2 (4%) 1 (2%) Mesentery (9) (9) (12) (6) Schwannoma Malignant 1 (11%) 1 (17%) Oral Mucosa (2) Squamous Cell Carcinoma 2 (100%) Pancreas (50) (50) (50) (50) Mixed Tumor Malignant 1 (2%) Squamous Cell Carcinoma, Metastatic, Stomach, Forestomach 1 (2%) Acinus, Adenoma 3 (6%) 1 (2%) 2 (4%) Salivary Glands (49) (50) (50) (50) Sarcoma 1 (2%) Stomach, Forestomach (50) (50) (50) (49) Squamous Cell Carcinoma 1 (2%) Squamous Cell Papilloma 1 (2%) 1 (2%) 1 (2%) Stomach, Glandular (50) (50) (50) (49) Tongue (1) (1) (1) (1) Squamous Cell Papilloma 1 (100%) ____________________________________________________________________________________________________________________________________ Page 7 NTP Experiment-Test: 93020-07 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC DIISOPROPYLCARBODIIMIDE Date: 06/30/04 Route: SKIN APPLICATION Time: 11:19:18 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (50) (50) (50) (50) Schwannoma Malignant 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (50) (49) (50) (50) Adrenal Medulla (50) (48) (50) (50) Ganglioneuroma 1 (2%) Pheochromocytoma Malignant 3 (6%) 4 (8%) 4 (8%) 2 (4%) Pheochromocytoma Malignant, Multiple 1 (2%) Pheochromocytoma Complex 1 (2%) Pheochromocytoma Benign 3 (6%) 2 (4%) 8 (16%) 7 (14%) Islets, Pancreatic (50) (50) (50) (50) Adenoma 4 (8%) 12 (24%) 9 (18%) 5 (10%) Adenoma, Multiple 1 (2%) 1 (2%) Carcinoma 2 (4%) 1 (2%) 1 (2%) Parathyroid Gland (49) (48) (49) (48) Adenoma 1 (2%) Pituitary Gland (50) (50) (50) (50) Pars Distalis, Adenoma 28 (56%) 33 (66%) 38 (76%) 17 (34%) Pars Distalis, Adenoma, Multiple 1 (2%) 4 (8%) 3 (6%) Pars Distalis, Carcinoma 5 (10%) 1 (2%) 2 (4%) Pars Intermedia, Adenoma 2 (4%) Pars Intermedia, Carcinoma 1 (2%) Thyroid Gland (50) (50) (50) (50) Sarcoma, Metastatic, Salivary Glands 1 (2%) Bilateral, C-Cell, Adenoma 1 (2%) C-Cell, Adenoma 3 (6%) 8 (16%) 8 (16%) 4 (8%) C-Cell, Adenoma, Multiple 1 (2%) 1 (2%) C-Cell, Carcinoma 5 (10%) 1 (2%) 2 (4%) Follicular Cell, Adenoma 1 (2%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM Tissue NOS (1) (1) Hemangioma 1 (100%) Lipoma 1 (100%) ____________________________________________________________________________________________________________________________________ Page 8 NTP Experiment-Test: 93020-07 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC DIISOPROPYLCARBODIIMIDE Date: 06/30/04 Route: SKIN APPLICATION Time: 11:19:18 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Preputial Gland (50) (50) (50) (50) Adenoma 1 (2%) 1 (2%) 1 (2%) 4 (8%) Carcinoma 1 (2%) 2 (4%) Prostate (50) (50) (50) (50) Adenoma 1 (2%) 2 (4%) 1 (2%) Seminal Vesicle (50) (50) (50) (50) Testes (50) (50) (50) (50) Bilateral, Interstitial Cell, Adenoma 21 (42%) 27 (54%) 15 (30%) 14 (28%) Interstitial Cell, Adenoma 15 (30%) 10 (20%) 16 (32%) 8 (16%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (50) (50) (50) (50) Lymph Node (18) (14) (16) (13) Mediastinal, Hemangiosarcoma 1 (6%) Lymph Node, Mesenteric (50) (50) (50) (50) Schwannoma Malignant, Metastatic, Mesentery 1 (2%) Spleen (50) (50) (50) (50) Thymus (49) (46) (46) (49) Thymoma Benign 1 (2%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (49) (48) (47) (48) Carcinoma 1 (2%) Fibroadenoma 4 (8%) 1 (2%) 1 (2%) Skin (49) (50) (50) (50) Keratoacanthoma 3 (6%) 1 (2%) 3 (6%) 1 (2%) Squamous Cell Papilloma 1 (2%) 1 (2%) 1 (2%) Sebaceous Gland, Carcinoma 1 (2%) 1 (2%) 1 (2%) Subcutaneous Tissue, Fibroma 5 (10%) 4 (8%) 2 (4%) 3 (6%) Subcutaneous Tissue, Fibrosarcoma 1 (2%) Subcutaneous Tissue, Lipoma 3 (6%) 1 (2%) Subcutaneous Tissue, Schwannoma Malignant 2 (4%) 2 (4%) 2 (4%) ____________________________________________________________________________________________________________________________________ Page 9 NTP Experiment-Test: 93020-07 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC DIISOPROPYLCARBODIIMIDE Date: 06/30/04 Route: SKIN APPLICATION Time: 11:19:18 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (50) (50) (50) (50) Osteoma 1 (2%) Osteosarcoma 1 (2%) Skeletal Muscle (3) (1) (1) (5) Lipoma 1 (33%) Sarcoma 1 (33%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (50) (50) (50) Astrocytoma Malignant 1 (2%) Carcinoma, Metastatic, Pituitary Gland 5 (10%) 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (50) (50) (50) Alveolar/Bronchiolar Adenoma 1 (2%) 2 (4%) Pheochromocytoma Malignant, Metastatic, Adrenal Medulla 1 (2%) 2 (4%) Schwannoma Malignant, Metastatic, Mesentery 1 (2%) Squamous Cell Carcinoma, Metastatic, Stomach, Forestomach 1 (2%) Nose (50) (50) (50) (50) Squamous Cell Carcinoma 1 (2%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (50) (50) (50) (50) Harderian Gland (50) (50) (50) (50) Zymbal's Gland (1) Carcinoma 1 (100%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (50) (50) (50) Page 10 NTP Experiment-Test: 93020-07 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC DIISOPROPYLCARBODIIMIDE Date: 06/30/04 Route: SKIN APPLICATION Time: 11:19:18 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS Multiple Organs *(50) *(50) *(50) *(50) Leukemia Mononuclear 13 (26%) 22 (44%) 13 (26%) 6 (12%) Lymphoma Malignant 2 (4%) 1 (2%) Mesothelioma Malignant 1 (2%) 2 (4%) 4 (8%) 1 (2%) ____________________________________________________________________________________________________________________________________ * Number of animals with any tissue examined microscopically Page 11 NTP Experiment-Test: 93020-07 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC DIISOPROPYLCARBODIIMIDE Date: 06/30/04 Route: SKIN APPLICATION Time: 11:19:18 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG ____________________________________________________________________________________________________________________________________ TUMOR SUMMARY Total Animals with Primary Neoplasms (b) 50 50 50 33 Total Primary Neoplasms 141 154 148 89 Total Animals with Benign Neoplasms 47 48 50 32 Total Benign Neoplasms 99 117 115 70 Total Animals with Malignant Neoplasms 34 31 27 15 Total Malignant Neoplasms 42 37 33 19 Total Animals with Metastatic Neoplasms 7 2 3 1 Total Metastatic Neoplasm 7 5 4 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 12 ------------------------------------------------------------ ---------- END 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