TDMS Study 97006-01 Pathology Tables
NTP Experiment-Test: 97006-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC METHYL ISOBUTYL KETONE Date: 05/11/04 Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 08:46:56 FINAL#1/RATS Facility: Battelle Northwest Chemical CAS #: 108-10-1 Lock Date: 01/24/03 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: 97006-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC METHYL ISOBUTYL KETONE Date: 05/11/04 Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 08:46:56 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE CONTROL 450 PPM 900 PPM 1800 PPM ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially in Study 50 50 50 50 Early Deaths Moribund Sacrifice 14 14 20 15 Natural Death 1 2 4 3 Survivors Moribund Sacrifice 1 Terminal Sacrifice 35 33 26 32 Animals Examined Microscopically 50 50 50 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Colon (50) (49) (49) (50) Adenoma 1 (2%) Liver (50) (50) (50) (50) Carcinoma, Metastatic, Adrenal Cortex 1 (2%) Hepatocellular Adenoma 1 (2%) 1 (2%) Histiocytic Sarcoma 1 (2%) Mesentery (18) (17) (15) (15) Histiocytic Sarcoma 1 (7%) Schwannoma Malignant 1 (6%) Oral Mucosa (1) Squamous Cell Carcinoma 1 (100%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (50) (50) (50) (50) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (50) (50) (50) (50) Carcinoma 1 (2%) Adrenal Medulla (50) (50) (50) (50) Pheochromocytoma Malignant 1 (2%) 1 (2%) Pheochromocytoma Benign 3 (6%) 2 (4%) 2 (4%) Islets, Pancreatic (50) (50) (50) (50) Adenoma 1 (2%) Pituitary Gland (49) (50) (50) (50) Page 2 NTP Experiment-Test: 97006-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC METHYL ISOBUTYL KETONE Date: 05/11/04 Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 08:46:56 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE CONTROL 450 PPM 900 PPM 1800 PPM ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM - cont Adenoma 24 (49%) 28 (56%) 26 (52%) 30 (60%) Carcinoma 1 (2%) Thyroid Gland (50) (50) (50) (50) Bilateral, C-Cell, Adenoma 1 (2%) C-Cell, Adenoma 3 (6%) 1 (2%) 2 (4%) 2 (4%) C-Cell, Carcinoma 1 (2%) 1 (2%) 1 (2%) 2 (4%) Follicular Cell, Adenoma 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Clitoral Gland (50) (50) (50) (50) Carcinoma 1 (2%) 3 (6%) 1 (2%) 3 (6%) Ovary (50) (50) (50) (50) Cystadenocarcinoma 1 (2%) Cystadenocarcinoma, Metastatic, Ovary 1 (2%) Granulosa Cell Tumor Benign 1 (2%) Thecoma Malignant 1 (2%) Uterus (50) (50) (50) (50) Carcinoma 1 (2%) Hemangioma 1 (2%) Histiocytic Sarcoma 1 (2%) Leiomyosarcoma 1 (2%) Polyp Stromal 11 (22%) 4 (8%) 7 (14%) 13 (26%) Polyp Stromal, Multiple 1 (2%) Sarcoma Stromal 1 (2%) 1 (2%) Bilateral, Polyp Stromal 1 (2%) 1 (2%) Cervix, Polyp Stromal 1 (2%) Serosa, Hemangioma 1 (2%) Vagina (2) (1) Histiocytic Sarcoma 1 (50%) Sarcoma 1 (50%) ____________________________________________________________________________________________________________________________________ Page 3 NTP Experiment-Test: 97006-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC METHYL ISOBUTYL KETONE Date: 05/11/04 Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 08:46:56 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE CONTROL 450 PPM 900 PPM 1800 PPM ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (50) (50) (50) (50) Lymph Node (1) (2) (2) (3) Deep Cervical, Carcinoma, Metastatic, Thyroid Gland 1 (50%) 1 (33%) Lymph Node, Bronchial (9) (12) (8) (7) Carcinoma, Metastatic, Thyroid Gland 1 (8%) 1 (14%) Cystadenocarcinoma, Metastatic, Ovary 1 (13%) Sarcoma, Metastatic, Skin 1 (14%) Lymph Node, Mandibular (1) (2) (1) Lymph Node, Mesenteric (50) (50) (50) (50) Histiocytic Sarcoma 1 (2%) Lymph Node, Mediastinal (46) (44) (46) (49) Carcinoma, Metastatic, Zymbal's Gland 1 (2%) Cystadenocarcinoma, Metastatic, Ovary 1 (2%) Spleen (50) (50) (50) (50) Histiocytic Sarcoma 1 (2%) Thymus (47) (49) (49) (49) Cystadenocarcinoma, Metastatic, Ovary 1 (2%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (50) (50) (50) (50) Carcinoma 5 (10%) 8 (16%) 6 (12%) 4 (8%) Fibroadenoma 17 (34%) 11 (22%) 18 (36%) 10 (20%) Fibroadenoma, Multiple 5 (10%) 8 (16%) 7 (14%) 8 (16%) Skin (50) (50) (50) (50) Basal Cell Carcinoma 1 (2%) Schwannoma Malignant 1 (2%) Squamous Cell Papilloma 1 (2%) Subcutaneous Tissue, Fibroma 1 (2%) Subcutaneous Tissue, Fibrosarcoma 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (50) (50) (50) (50) Cranium, Carcinoma, Metastatic, Pituitary Gland 1 (2%) Skeletal Muscle (10) (5) (8) (14) Cystadenocarcinoma, Metastatic, Ovary 1 (13%) Sarcoma 1 (13%) Page 4 NTP Experiment-Test: 97006-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC METHYL ISOBUTYL KETONE Date: 05/11/04 Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 08:46:56 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE CONTROL 450 PPM 900 PPM 1800 PPM ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM - cont Schwannoma Malignant 1 (20%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (50) (50) (50) Histiocytic Sarcoma 1 (2%) Pineal Gland, Adenoma 1 (2%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (50) (50) (50) Alveolar/Bronchiolar Adenoma 1 (2%) 1 (2%) Carcinoma, Metastatic, Clitoral Gland 1 (2%) 1 (2%) Carcinoma, Metastatic, Thyroid Gland 1 (2%) 1 (2%) Carcinoma, Metastatic, Zymbal's Gland 1 (2%) Carcinoma, Metastatic, Adrenal Cortex 1 (2%) Cystadenocarcinoma, Metastatic, Ovary 1 (2%) Pheochromocytoma Malignant, Metastatic, Adrenal Medulla 1 (2%) Sarcoma, Metastatic, Skin 1 (2%) Mediastinum, Schwannoma Malignant, Metastatic, Mesentery 1 (2%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Harderian Gland (50) (50) (50) (50) Sarcoma 1 (2%) Zymbal's Gland (3) (1) Carcinoma 2 (67%) 1 (100%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (50) (50) (50) Cystadenocarcinoma, Metastatic, Ovary 1 (2%) Page 5 NTP Experiment-Test: 97006-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC METHYL ISOBUTYL KETONE Date: 05/11/04 Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 08:46:56 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE CONTROL 450 PPM 900 PPM 1800 PPM ____________________________________________________________________________________________________________________________________ URINARY SYSTEM - cont Mesenchymal Tumor Malignant 2 (4%) ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS Multiple Organs *(50) *(50) *(50) *(50) Histiocytic Sarcoma 2 (4%) 1 (2%) Leukemia Mononuclear 14 (28%) 21 (42%) 12 (24%) 16 (32%) ____________________________________________________________________________________________________________________________________ * Number of animals with any tissue examined microscopically Page 6 NTP Experiment-Test: 97006-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC METHYL ISOBUTYL KETONE Date: 05/11/04 Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 08:46:56 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE CONTROL 450 PPM 900 PPM 1800 PPM ____________________________________________________________________________________________________________________________________ TUMOR SUMMARY Total Animals with Primary Neoplasms (b) 46 46 49 47 Total Primary Neoplasms 91 99 94 103 Total Animals with Benign Neoplasms 44 39 40 40 Total Benign Neoplasms 66 58 67 70 Total Animals with Malignant Neoplasms 22 27 22 25 Total Malignant Neoplasms 25 41 27 33 Total Animals with Metastatic Neoplasms 3 5 4 Total Metastatic Neoplasm 4 12 8 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 7 NTP Experiment-Test: 97006-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC METHYL ISOBUTYL KETONE Date: 05/11/04 Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 08:46:56 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE CONTROL 450 PPM 900 PPM 1800 PPM ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially in Study 50 50 50 50 Early Deaths Moribund Sacrifice 14 16 21 29 Natural Death 4 5 4 2 Accidently Killed 1 Survivors Terminal Sacrifice 32 28 25 19 Animals Examined Microscopically 50 50 50 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Rectum (49) (48) (50) (50) Adenoma 1 (2%) Liver (50) (50) (50) (50) Hepatocellular Adenoma 1 (2%) 1 (2%) Histiocytic Sarcoma 2 (4%) Oral Mucosa (2) Squamous Cell Carcinoma 1 (50%) Pancreas (50) (48) (50) (50) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (50) (49) (50) (50) Sarcoma, Metastatic, Lung 1 (2%) Schwannoma Malignant 1 (2%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (50) (48) (50) (50) Histiocytic Sarcoma 1 (2%) Adrenal Medulla (50) (48) (50) (50) Pheochromocytoma Malignant 2 (4%) 1 (2%) 2 (4%) Pheochromocytoma Benign 7 (14%) 4 (8%) 6 (12%) 11 (22%) Bilateral, Pheochromocytoma Benign 1 (2%) 3 (6%) 4 (8%) 1 (2%) Islets, Pancreatic (50) (48) (50) (50) Adenoma 3 (6%) 4 (8%) 1 (2%) 1 (2%) Carcinoma 4 (8%) 2 (4%) 2 (4%) 1 (2%) Page 8 NTP Experiment-Test: 97006-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC METHYL ISOBUTYL KETONE Date: 05/11/04 Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 08:46:56 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE CONTROL 450 PPM 900 PPM 1800 PPM ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM - cont Pituitary Gland (50) (49) (50) (50) Adenoma 35 (70%) 29 (59%) 30 (60%) 29 (58%) Thyroid Gland (50) (48) (50) (50) C-Cell, Adenoma 1 (2%) 4 (8%) 4 (8%) C-Cell, Carcinoma 2 (4%) 3 (6%) 1 (2%) Follicular Cell, Carcinoma 1 (2%) 2 (4%) 2 (4%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM Peritoneum (48) (46) (49) (49) ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Epididymis (50) (49) (50) (50) Preputial Gland (50) (49) (50) (50) Carcinoma 1 (2%) 1 (2%) Testes (50) (50) (50) (50) Bilateral, Interstitial Cell, Adenoma 28 (56%) 34 (68%) 37 (74%) 38 (76%) Interstitial Cell, Adenoma 14 (28%) 8 (16%) 7 (14%) 10 (20%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (50) (49) (50) (50) Histiocytic Sarcoma 1 (2%) Lymph Node (7) (7) (12) (15) Deep Cervical, Carcinoma, Metastatic, Thyroid Gland 1 (14%) 1 (7%) Lymph Node, Bronchial (11) (13) (12) (7) Carcinoma, Metastatic, Thyroid Gland 1 (8%) Sarcoma, Metastatic, Lung 1 (8%) Lymph Node, Mandibular (1) (1) (3) (2) Lymph Node, Mesenteric (50) (48) (50) (50) Lymph Node, Mediastinal (41) (44) (46) (44) Carcinoma, Metastatic, Thyroid Gland 1 (2%) Sarcoma, Metastatic, Lung 1 (2%) Spleen (50) (50) (50) (50) Hemangioma 1 (2%) Histiocytic Sarcoma 1 (2%) Schwannoma Malignant, Metastatic, Heart 1 (2%) Thymus (49) (47) (50) (49) Page 9 NTP Experiment-Test: 97006-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC METHYL ISOBUTYL KETONE Date: 05/11/04 Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 08:46:56 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE CONTROL 450 PPM 900 PPM 1800 PPM ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - cont Carcinoma, Metastatic, Thyroid Gland 1 (2%) Schwannoma Malignant, Metastatic, Heart 1 (2%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (49) (49) (50) (50) Carcinoma 2 (4%) 1 (2%) 1 (2%) Fibroadenoma 2 (4%) 2 (4%) 2 (4%) 1 (2%) Skin (50) (49) (50) (50) Basal Cell Adenoma 1 (2%) Basal Cell Carcinoma 1 (2%) Fibrous Histiocytoma 1 (2%) Keratoacanthoma 1 (2%) Sarcoma 1 (2%) 1 (2%) Squamous Cell Papilloma 1 (2%) Sebaceous Gland, Adenoma 1 (2%) 1 (2%) Subcutaneous Tissue, Fibroma 4 (8%) 1 (2%) 2 (4%) 2 (4%) Subcutaneous Tissue, Fibrosarcoma 1 (2%) 2 (4%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Skeletal Muscle (3) (3) (4) (6) Sarcoma, Metastatic, Lung 1 (33%) Schwannoma Malignant, Metastatic, Heart 1 (33%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (49) (50) (50) Glioma Malignant 1 (2%) Granular Cell Tumor Malignant 1 (2%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Larynx (50) (48) (50) (50) Carcinoma, Metastatic, Thyroid Gland 1 (2%) Lung (50) (49) (50) (50) Alveolar/Bronchiolar Carcinoma 2 (4%) Carcinoma, Metastatic, Mammary Gland 1 (2%) Carcinoma, Metastatic, Thyroid Gland 1 (2%) Page 10 NTP Experiment-Test: 97006-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC METHYL ISOBUTYL KETONE Date: 05/11/04 Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 08:46:56 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE CONTROL 450 PPM 900 PPM 1800 PPM ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM - cont Carcinoma, Metastatic, Zymbal's Gland 1 (2%) Fibrosarcoma, Metastatic, Skin 1 (2%) Schwannoma Malignant, Metastatic, Heart 1 (2%) Mediastinum, Sarcoma 2 (4%) Mediastinum, Schwannoma Malignant, Metastatic, Heart 1 (2%) Pleura (50) (49) (50) (50) Schwannoma Malignant, Metastatic, Heart 1 (2%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (49) (45) (46) (48) Carcinoma, Metastatic, Oral Mucosa 1 (2%) Zymbal's Gland (1) (2) Carcinoma 1 (100%) 2 (100%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (50) (50) (50) Renal Tubule, Adenoma 2 (4%) 3 (6%) Renal Tubule, Carcinoma 1 (2%) 2 (4%) Urinary Bladder (50) (48) (50) (50) Leiomyoma 1 (2%) Transitional Epithelium, Papilloma 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS Multiple Organs *(50) *(50) *(50) *(50) Histiocytic Sarcoma 2 (4%) Leukemia Mononuclear 25 (50%) 26 (52%) 32 (64%) 35 (70%) Mesothelioma Malignant 1 (2%) 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ * Number of animals with any tissue examined microscopically Page 11 NTP Experiment-Test: 97006-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC METHYL ISOBUTYL KETONE Date: 05/11/04 Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 08:46:56 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE CONTROL 450 PPM 900 PPM 1800 PPM ____________________________________________________________________________________________________________________________________ TUMOR SUMMARY Total Animals with Primary Neoplasms (b) 50 48 49 50 Total Primary Neoplasms 139 136 133 154 Total Animals with Benign Neoplasms 50 47 47 49 Total Benign Neoplasms 99 89 94 105 Total Animals with Malignant Neoplasms 31 35 34 41 Total Malignant Neoplasms 40 47 39 49 Total Animals with Metastatic Neoplasms 3 3 1 2 Total Metastatic Neoplasm 8 9 2 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 12 ------------------------------------------------------------ ---------- END OF REPORT ---------- ------------------------------------------------------------