TDMS Study 05165-01 Pathology Tables
NTP Experiment-Test: 05165-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC 4,4 THIOBIS-(6-T-BUTYL-M-CRESOL) Date: 11/10/95 Route: DOSED FEED Time: 16:15:07 Facility: Battelle Columbus Laboratory Chemical CAS #: 96-69-5 Lock Date: 12/26/91 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: 05165-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC 4,4 THIOBIS-(6-T-BUTYL-M-CRESOL) Date: 11/10/95 Route: DOSED FEED Time: 16:15:07 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 PPM 0 PPM 500 PPM 500 PPM 1000 PPM 1000 PPM 65 PATH 65 PATH 65 PATH ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially in Study 50 10 50 10 50 10 Scheduled Sacrifice 10 10 10 Early Deaths Moribund Sacrifice 11 14 16 Natural Death 5 5 2 Survivors Terminal Sacrifice 34 30 32 Natural Death 1 Animals Examined Microscopically 50 10 50 10 50 10 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Cecum (50) (10) (50) (10) (50) (10) Intestine Small, Duodenum (50) (10) (50) (10) (50) (10) Liver (50) (10) (50) (10) (50) (10) Mesentery (9) (1) (7) (2) (8) Schwannoma Malignant 1 (14%) Pancreas (50) (10) (50) (10) (50) (10) Pharynx (1) (2) Palate, Squamous Cell Papilloma 1 (100%) 2 (100%) Salivary Glands (49) (10) (49) (10) (50) (10) Stomach, Glandular (50) (10) (50) (10) (50) (10) Tongue (1) Squamous Cell Papilloma 1 (100%) Tooth (2) (1) Gingiva, Squamous Cell Carcinoma 1 (50%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (50) (10) (50) (10) (50) (10) Schwannoma Malignant, Moderately Well Differentiated 1 (2%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (50) (10) (50) (10) (50) (10) Adenoma 1 (2%) 1 (2%) Adrenal Medulla (50) (10) (50) (10) (49) (10) Pheochromocytoma Benign 1 (2%) 1 (2%) 3 (6%) Bilateral, Pheochromocytoma Benign 1 (2%) Page 2 NTP Experiment-Test: 05165-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC 4,4 THIOBIS-(6-T-BUTYL-M-CRESOL) Date: 11/10/95 Route: DOSED FEED Time: 16:15:07 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 PPM 0 PPM 500 PPM 500 PPM 1000 PPM 1000 PPM 65 PATH 65 PATH 65 PATH ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM - cont Islets, Pancreatic (50) (10) (50) (10) (50) (10) Carcinoma 1 (2%) Pituitary Gland (49) (10) (50) (10) (50) (10) Pars Distalis, Adenoma 27 (55%) 3 (30%) 15 (30%) 1 (10%) 17 (34%) Thyroid Gland (49) (10) (49) (10) (50) (10) Bilateral, C-Cell, Adenoma 1 (2%) C-Cell, Adenoma 3 (6%) 2 (4%) 7 (14%) C-Cell, Carcinoma 2 (4%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Clitoral Gland (49) (10) (48) (10) (50) (10) Adenoma 4 (8%) 1 (2%) Carcinoma 1 (2%) 1 (2%) Ovary (50) (10) (50) (10) (50) (10) Uterus (50) (10) (50) (10) (50) (10) Polyp Stromal 2 (4%) 5 (10%) 9 (18%) 1 (10%) Sarcoma Stromal 1 (2%) Vagina (2) Fibrosarcoma 1 (50%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (49) (10) (50) (10) (50) (10) Lymph Node (14) (10) (10) Lymph Node, Mandibular (49) (10) (49) (10) (50) (10) Lymph Node, Mesenteric (50) (10) (50) (10) (50) (10) Spleen (50) (10) (50) (10) (50) (10) Thymus (47) (10) (49) (10) (47) (10) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (50) (10) (50) (10) (50) (10) Adenocarcinoma 1 (2%) Adenoma 2 (4%) 1 (2%) Fibroadenoma 18 (36%) 14 (28%) 1 (10%) 9 (18%) Fibroadenoma, Multiple 11 (22%) 10 (20%) 2 (4%) Skin (50) (10) (50) (10) (50) (10) Squamous Cell Papilloma 1 (2%) Page 3 NTP Experiment-Test: 05165-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC 4,4 THIOBIS-(6-T-BUTYL-M-CRESOL) Date: 11/10/95 Route: DOSED FEED Time: 16:15:07 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 PPM 0 PPM 500 PPM 500 PPM 1000 PPM 1000 PPM 65 PATH 65 PATH 65 PATH ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM - cont Subcutaneous Tissue, Fibroma 1 (2%) 1 (2%) Subcutaneous Tissue, Lipoma 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (49) (10) (50) (10) (50) (10) Cervical, Vertebra, Hemangiosarcoma 1 (2%) Femur, Osteosarcoma 1 (2%) Skeletal Muscle (50) (10) (50) (10) (50) (10) Osteosarcoma, Metastatic, Bone 1 (2%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (10) (50) (10) (50) (10) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (10) (49) (10) (49) (10) Alveolar/Bronchiolar Adenoma 1 (2%) 1 (2%) Carcinoma, Metastatic, Thyroid Gland 1 (2%) Fibrosarcoma 1 (2%) Osteosarcoma, Metastatic, Bone 1 (2%) Nose (50) (10) (50) (10) (50) (10) Squamous Cell Carcinoma, Metastatic, Tooth 1 (2%) Trachea (50) (10) (50) (10) (50) (10) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Ear (1) Fibrosarcoma 1 (100%) Harderian Gland (49) (10) (50) (10) (50) (10) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (10) (50) (10) (50) (10) Urinary Bladder (50) (10) (49) (10) (50) (10) ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS Multiple Organs *(50) *(10) *(50) *(10) *(50) *(10) Leukemia Mononuclear 18 (36%) 18 (36%) 22 (44%) * Number of animals with any tissue examined microscopically Page 4 NTP Experiment-Test: 05165-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC 4,4 THIOBIS-(6-T-BUTYL-M-CRESOL) Date: 11/10/95 Route: DOSED FEED Time: 16:15:07 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 PPM 0 PPM 500 PPM 500 PPM 1000 PPM 1000 PPM 65 PATH 65 PATH 65 PATH ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS - cont Multiple Organs *(50) *(10) *(50) *(10) *(50) *(10) ____________________________________________________________________________________________________________________________________ Page 5 NTP Experiment-Test: 05165-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC 4,4 THIOBIS-(6-T-BUTYL-M-CRESOL) Date: 11/10/95 Route: DOSED FEED Time: 16:15:07 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 PPM 0 PPM 500 PPM 500 PPM 1000 PPM 1000 PPM 65 PATH 65 PATH 65 PATH ____________________________________________________________________________________________________________________________________ TUMOR SUMMARY Total Animals with Primary Neoplasms (b) 47 3 45 2 43 1 Total Primary Neoplasms 98 3 76 2 78 1 Total Animals with Benign Neoplasms 42 3 35 2 36 1 Total Benign Neoplasms 75 3 52 2 52 1 Total Animals with Malignant Neoplasms 22 23 24 Total Malignant Neoplasms 23 24 26 Total Animals with Metastatic Neoplasms 2 1 Total Metastatic Neoplasm 3 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 6 NTP Experiment-Test: 05165-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC 4,4 THIOBIS-(6-T-BUTYL-M-CRESOL) Date: 11/10/95 Route: DOSED FEED Time: 16:15:07 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 2500 PPM 2500 PPM 65 PATH ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially in Study 50 10 Scheduled Sacrifice 10 Early Deaths Moribund Sacrifice 16 Natural Death 6 Survivors Terminal Sacrifice 28 Animals Examined Microscopically 50 10 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Colon (49) (10) Intestine Large, Cecum (49) (9) Intestine Small, Duodenum (49) (10) Intestine Small, Jejunum (49) (10) Adenocarcinoma 1 (2%) Intestine Small, Ileum (49) (10) Liver (50) (10) Hepatocellular Adenoma 1 (2%) Mesentery (4) Pancreas (49) (10) Stomach, Forestomach (49) (10) Stomach, Glandular (49) (10) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (50) (10) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (50) (10) Adrenal Medulla (50) (10) Pheochromocytoma Malignant 1 (2%) Pheochromocytoma Benign 1 (2%) Pituitary Gland (49) (10) Pars Distalis, Adenoma 16 (33%) 1 (10%) Pars Distalis, Adenoma, Multiple 1 (2%) Pars Distalis, Carcinoma 1 (2%) Thyroid Gland (50) (10) C-Cell, Adenoma 8 (16%) Page 7 NTP Experiment-Test: 05165-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC 4,4 THIOBIS-(6-T-BUTYL-M-CRESOL) Date: 11/10/95 Route: DOSED FEED Time: 16:15:07 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 2500 PPM 2500 PPM 65 PATH ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM - cont C-Cell, Carcinoma 2 (4%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Clitoral Gland (49) (10) Adenoma 1 (2%) Carcinoma 2 (4%) Ovary (50) (10) Uterus (50) (10) Polyp Stromal 9 (18%) Sarcoma Stromal 1 (2%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (50) (10) Lymph Node (10) Lymph Node, Mandibular (50) (10) Lymph Node, Mesenteric (50) (10) Spleen (50) (10) Thymus (48) (10) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (50) (10) Fibroadenoma 14 (28%) Fibroadenoma, Multiple 2 (4%) Skin (50) (10) Subcutaneous Tissue, Fibroma 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Skeletal Muscle (50) (10) ____________________________________________________________________________________________________________________________________ Page 8 NTP Experiment-Test: 05165-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC 4,4 THIOBIS-(6-T-BUTYL-M-CRESOL) Date: 11/10/95 Route: DOSED FEED Time: 16:15:07 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 2500 PPM 2500 PPM 65 PATH ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (10) Spinal Cord (1) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (10) Alveolar/Bronchiolar Adenoma 1 (2%) Carcinoma, Metastatic, Thyroid Gland 1 (2%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM None ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (10) Urinary Bladder (50) (10) ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS Multiple Organs *(50) *(10) Leukemia Mononuclear 20 (40%) ____________________________________________________________________________________________________________________________________ * Number of animals with any tissue examined microscopically Page 9 NTP Experiment-Test: 05165-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC 4,4 THIOBIS-(6-T-BUTYL-M-CRESOL) Date: 11/10/95 Route: DOSED FEED Time: 16:15:07 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 2500 PPM 2500 PPM 65 PATH ____________________________________________________________________________________________________________________________________ TUMOR SUMMARY Total Animals with Primary Neoplasms (b) 47 1 Total Primary Neoplasms 83 1 Total Animals with Benign Neoplasms 38 1 Total Benign Neoplasms 55 1 Total Animals with Malignant Neoplasms 25 Total Malignant Neoplasms 28 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 10 NTP Experiment-Test: 05165-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC 4,4 THIOBIS-(6-T-BUTYL-M-CRESOL) Date: 11/10/95 Route: DOSED FEED Time: 16:15:07 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 PPM 0 PPM 500 PPM 500 PPM 1000 PPM 1000 PPM 65 PATH 65 PATH 65 PATH ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially in Study 50 10 50 10 50 10 Scheduled Sacrifice 10 10 7 Early Deaths Moribund Sacrifice 23 14 22 3 Natural Death 9 8 6 Survivors Terminal Sacrifice 18 28 22 Animals Examined Microscopically 50 10 50 10 50 10 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Colon (50) (10) (50) (10) (50) (10) Polyp Adenomatous 1 (2%) Intestine Large, Rectum (50) (10) (50) (10) (50) (10) Adenocarcinoma 1 (2%) Intestine Small, Jejunum (50) (10) (50) (10) (50) (10) Adenocarcinoma 1 (2%) Liver (50) (10) (50) (10) (50) (10) Hepatocellular Carcinoma 1 (2%) Hepatocellular Adenoma 1 (2%) 2 (4%) 2 (4%) Hepatocellular Adenoma, Multiple 1 (2%) Histiocytic Sarcoma 1 (2%) Mesentery (11) (2) (7) (1) (10) (1) Histiocytic Sarcoma 1 (10%) Liposarcoma 1 (14%) Pancreas (50) (10) (50) (10) (50) (10) Histiocytic Sarcoma 1 (2%) Pharynx (1) (1) Squamous Cell Papilloma 1 (100%) Palate, Squamous Cell Papilloma 1 (100%) Salivary Glands (49) (10) (50) (10) (50) (10) Stomach, Forestomach (50) (10) (50) (10) (50) (10) Leiomyosarcoma 1 (2%) Stomach, Glandular (50) (10) (50) (10) (50) (10) Tongue (1) (2) (1) Squamous Cell Papilloma 1 (100%) 1 (50%) 1 (100%) Tooth (1) Peridontal Tissue, Fibrosarcoma 1 (100%) ____________________________________________________________________________________________________________________________________ Page 11 NTP Experiment-Test: 05165-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC 4,4 THIOBIS-(6-T-BUTYL-M-CRESOL) Date: 11/10/95 Route: DOSED FEED Time: 16:15:07 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 PPM 0 PPM 500 PPM 500 PPM 1000 PPM 1000 PPM 65 PATH 65 PATH 65 PATH ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (50) (10) (50) (10) (50) (10) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (50) (10) (50) (10) (50) (10) Adrenal Medulla (50) (10) (50) (10) (50) (10) Pheochromocytoma Malignant 1 (2%) Pheochromocytoma Benign 11 (22%) 1 (10%) 12 (24%) 1 (10%) 7 (14%) Bilateral, Pheochromocytoma Benign 3 (6%) 2 (4%) 3 (6%) Islets, Pancreatic (50) (10) (50) (10) (50) (10) Adenoma 2 (4%) 1 (10%) Carcinoma 1 (2%) 1 (2%) Parathyroid Gland (47) (10) (45) (10) (47) (10) Adenoma 2 (4%) Pituitary Gland (50) (10) (49) (10) (50) (10) Histiocytic Sarcoma 1 (2%) Pars Distalis, Adenoma 14 (28%) 1 (10%) 10 (20%) 2 (20%) 10 (20%) 1 (10%) Pars Distalis, Adenoma, Multiple 2 (4%) Pars Intermedia, Carcinoma 1 (2%) Thyroid Gland (50) (10) (50) (10) (50) (10) Bilateral, C-Cell, Adenoma 1 (2%) C-Cell, Adenoma 4 (8%) 3 (6%) 8 (16%) Follicular Cell, Adenoma 2 (4%) 1 (10%) 1 (2%) Follicular Cell, Carcinoma 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Epididymis (50) (10) (50) (10) (50) (10) Preputial Gland (50) (10) (49) (10) (49) (10) Adenoma 1 (2%) 4 (8%) 2 (4%) Carcinoma 2 (4%) 2 (4%) Histiocytic Sarcoma 1 (2%) Bilateral, Adenoma 1 (2%) 1 (2%) Prostate (49) (10) (50) (10) (50) (10) Seminal Vesicle (49) (10) (50) (10) (50) (10) Testes (50) (10) (49) (10) (50) (10) Bilateral, Interstitial Cell, Adenoma 36 (72%) 5 (50%) 38 (78%) 5 (50%) 42 (84%) 2 (20%) Interstitial Cell, Adenoma 10 (20%) 1 (10%) 6 (12%) 3 (30%) 5 (10%) 4 (40%) ____________________________________________________________________________________________________________________________________ Page 12 NTP Experiment-Test: 05165-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC 4,4 THIOBIS-(6-T-BUTYL-M-CRESOL) Date: 11/10/95 Route: DOSED FEED Time: 16:15:07 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 PPM 0 PPM 500 PPM 500 PPM 1000 PPM 1000 PPM 65 PATH 65 PATH 65 PATH ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (50) (10) (50) (10) (50) (10) Femoral, Histiocytic Sarcoma 1 (2%) Maxilla, Histiocytic Sarcoma 1 (2%) Lymph Node (24) (19) (26) Mediastinal, Histiocytic Sarcoma 1 (4%) Pancreatic, Histiocytic Sarcoma 1 (4%) Renal, Leiomyosarcoma, Metastatic, Stomach, Forestomach 1 (4%) Lymph Node, Mandibular (48) (10) (50) (10) (50) (10) Histiocytic Sarcoma 1 (2%) Lymph Node, Mesenteric (50) (10) (50) (10) (49) (10) Histiocytic Sarcoma 1 (2%) Spleen (50) (10) (50) (10) (49) (10) Fibrosarcoma 1 (2%) Histiocytic Sarcoma 1 (2%) Thymus (48) (10) (46) (10) (46) (10) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (47) (10) (47) (10) (46) (10) Adenoacanthoma 1 (2%) Fibroadenoma 3 (6%) 4 (9%) Skin (50) (10) (50) (10) (50) (10) Basosquamous Tumor Benign 1 (2%) Histiocytic Sarcoma 1 (2%) Keratoacanthoma 1 (2%) 1 (2%) 1 (2%) Squamous Cell Papilloma 2 (4%) 1 (2%) Sebaceous Gland, Adenocarcinoma 1 (2%) Sebaceous Gland, Adenoma 1 (2%) Subcutaneous Tissue, Fibroma 5 (10%) 1 (2%) 4 (8%) Subcutaneous Tissue, Fibrosarcoma 2 (4%) Subcutaneous Tissue, Neurofibroma 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (50) (10) (50) (10) (50) (10) Cranium, Chondrosarcoma 1 (2%) Cranium, Hemangiosarcoma 1 (10%) Cranium, Osteosarcoma 1 (2%) Femur, Histiocytic Sarcoma 1 (2%) Femur, Osteosarcoma 1 (2%) Maxilla, Histiocytic Sarcoma 1 (2%) Skeletal Muscle (50) (10) (50) (10) (50) (10) Page 13 NTP Experiment-Test: 05165-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC 4,4 THIOBIS-(6-T-BUTYL-M-CRESOL) Date: 11/10/95 Route: DOSED FEED Time: 16:15:07 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 PPM 0 PPM 500 PPM 500 PPM 1000 PPM 1000 PPM 65 PATH 65 PATH 65 PATH ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM - cont Histiocytic Sarcoma 1 (2%) Osteosarcoma, Metastatic, Bone 1 (2%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (10) (50) (10) (50) (10) Astrocytoma Malignant 2 (4%) Carcinoma, Metastatic, Pituitary Gland 1 (2%) Histiocytic Sarcoma 1 (2%) Oligodendroglioma Malignant 1 (2%) Spinal Cord (2) (2) (3) (1) Astrocytoma Malignant 1 (50%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (49) (10) (50) (10) (50) (10) Adenocarcinoma, Metastatic, Zymbal's Gland 1 (2%) Alveolar/Bronchiolar Adenoma 2 (4%) Alveolar/Bronchiolar Carcinoma 1 (2%) 1 (2%) Histiocytic Sarcoma 1 (2%) Osteosarcoma, Metastatic, Bone 1 (2%) Mediastinum, Schwannoma Malignant 1 (2%) Nose (50) (10) (50) (10) (50) (10) Chondrosarcoma, Metastatic, Bone 1 (2%) Squamous Cell Carcinoma 2 (4%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Ear (1) (1) (2) Fibrosarcoma 1 (100%) Eye (3) (2) (5) Lids, Left, Fibroma 1 (20%) Harderian Gland (49) (10) (49) (9) (50) (10) Zymbal's Gland (1) (1) (1) Adenocarcinoma 1 (100%) 1 (100%) 1 (100%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (10) (50) (10) (50) (10) Urinary Bladder (49) (10) (50) (10) (50) (10) Page 14 NTP Experiment-Test: 05165-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC 4,4 THIOBIS-(6-T-BUTYL-M-CRESOL) Date: 11/10/95 Route: DOSED FEED Time: 16:15:07 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 PPM 0 PPM 500 PPM 500 PPM 1000 PPM 1000 PPM 65 PATH 65 PATH 65 PATH ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS Multiple Organs *(50) *(10) *(50) *(10) *(50) *(10) Histiocytic Sarcoma 1 (2%) Leukemia Mononuclear 30 (60%) 36 (72%) 34 (68%) Mesothelioma Malignant 2 (4%) 1 (2%) ____________________________________________________________________________________________________________________________________ * Number of animals with any tissue examined microscopically Page 15 NTP Experiment-Test: 05165-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC 4,4 THIOBIS-(6-T-BUTYL-M-CRESOL) Date: 11/10/95 Route: DOSED FEED Time: 16:15:07 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 PPM 0 PPM 500 PPM 500 PPM 1000 PPM 1000 PPM 65 PATH 65 PATH 65 PATH ____________________________________________________________________________________________________________________________________ TUMOR SUMMARY Total Animals with Primary Neoplasms (b) 49 7 49 9 50 9 Total Primary Neoplasms 143 8 144 14 137 9 Total Animals with Benign Neoplasms 49 7 47 9 50 7 Total Benign Neoplasms 99 8 93 14 92 7 Total Animals with Malignant Neoplasms 37 41 39 2 Total Malignant Neoplasms 44 51 45 2 Total Animals with Metastatic Neoplasms 3 1 1 Total Metastatic Neoplasm 3 1 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 16 NTP Experiment-Test: 05165-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC 4,4 THIOBIS-(6-T-BUTYL-M-CRESOL) Date: 11/10/95 Route: DOSED FEED Time: 16:15:07 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 2500 PPM 2500 PPM 65 PATH ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially in Study 50 10 Scheduled Sacrifice 10 Early Deaths Moribund Sacrifice 23 Natural Death 9 Survivors Terminal Sacrifice 18 Animals Examined Microscopically 49 10 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Colon (48) (10) Intestine Large, Cecum (49) (10) Intestine Small, Ileum (49) (10) Carcinoma, Metastatic, Kidney 1 (2%) Liver (49) (10) Carcinoma, Metastatic, Kidney 1 (2%) Hepatocellular Carcinoma 1 (2%) Hepatocellular Adenoma 4 (8%) Mesentery (9) Pancreas (49) (10) Carcinoma, Metastatic, Kidney 1 (2%) Salivary Glands (49) (10) Carcinoma, Metastatic, Kidney 1 (2%) Stomach, Forestomach (49) (10) Stomach, Glandular (49) (10) Tongue (1) Carcinoma, Metastatic, Kidney 1 (100%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (49) (10) Carcinoma, Metastatic, Kidney 1 (2%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (49) (10) Carcinoma, Metastatic, Kidney 1 (2%) Adrenal Medulla (49) (10) Carcinoma, Metastatic, Kidney 1 (2%) Page 17 NTP Experiment-Test: 05165-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC 4,4 THIOBIS-(6-T-BUTYL-M-CRESOL) Date: 11/10/95 Route: DOSED FEED Time: 16:15:07 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 2500 PPM 2500 PPM 65 PATH ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM - cont Pheochromocytoma Benign 9 (18%) 1 (10%) Bilateral, Pheochromocytoma Malignant 1 (2%) Parathyroid Gland (46) (10) Adenoma 1 (2%) Pituitary Gland (49) (10) Pars Distalis, Adenoma 9 (18%) Pars Distalis, Adenoma, Multiple 1 (2%) Thyroid Gland (49) (10) Carcinoma, Metastatic, Kidney 1 (2%) C-Cell, Adenoma 2 (4%) 1 (10%) C-Cell, Carcinoma 1 (2%) Follicular Cell, Carcinoma 1 (2%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Epididymis (49) (10) Preputial Gland (49) (10) Adenoma 4 (8%) Prostate (48) (10) Carcinoma, Metastatic, Kidney 1 (2%) Seminal Vesicle (48) (10) Testes (49) (10) Bilateral, Interstitial Cell, Adenoma 31 (63%) 3 (30%) Interstitial Cell, Adenoma 13 (27%) 3 (30%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (49) (10) Lymph Node (30) Mediastinal, Carcinoma, Metastatic, Kidney 1 (3%) Lymph Node, Mandibular (49) (10) Lymph Node, Mesenteric (48) (10) Carcinoma, Metastatic, Kidney 1 (2%) Spleen (49) (10) Thymus (46) (10) ____________________________________________________________________________________________________________________________________ Page 18 NTP Experiment-Test: 05165-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC 4,4 THIOBIS-(6-T-BUTYL-M-CRESOL) Date: 11/10/95 Route: DOSED FEED Time: 16:15:07 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 2500 PPM 2500 PPM 65 PATH ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (49) (10) Fibroadenoma 2 (4%) Skin (48) (10) Keratoacanthoma 2 (4%) Squamous Cell Papilloma 1 (2%) Subcutaneous Tissue, Fibroma 1 (2%) Subcutaneous Tissue, Fibroma, Multiple 1 (2%) Subcutaneous Tissue, Hemangioma 1 (2%) Subcutaneous Tissue, Neurofibroma 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Skeletal Muscle (49) (10) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (49) (10) Astrocytoma Malignant 2 (4%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (49) (10) Carcinoma, Metastatic, Kidney 1 (2%) Pheochromocytoma Malignant, Metastatic, Adrenal Medulla 1 (2%) Nose (49) (10) Carcinoma, Metastatic, Kidney 1 (2%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM None ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (49) (10) Renal Tubule, Carcinoma 1 (2%) Urinary Bladder (48) (10) Page 19 NTP Experiment-Test: 05165-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC 4,4 THIOBIS-(6-T-BUTYL-M-CRESOL) Date: 11/10/95 Route: DOSED FEED Time: 16:15:07 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 2500 PPM 2500 PPM 65 PATH ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS Multiple Organs *(49) *(10) Leukemia Mononuclear 33 (67%) Mesothelioma Benign 1 (10%) ____________________________________________________________________________________________________________________________________ * Number of animals with any tissue examined microscopically Page 20 NTP Experiment-Test: 05165-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC 4,4 THIOBIS-(6-T-BUTYL-M-CRESOL) Date: 11/10/95 Route: DOSED FEED Time: 16:15:07 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 2500 PPM 2500 PPM 65 PATH ____________________________________________________________________________________________________________________________________ TUMOR SUMMARY Total Animals with Primary Neoplasms (b) 49 7 Total Primary Neoplasms 123 9 Total Animals with Benign Neoplasms 46 7 Total Benign Neoplasms 83 9 Total Animals with Malignant Neoplasms 37 Total Malignant Neoplasms 40 Total Animals with Metastatic Neoplasms 2 Total Metastatic Neoplasm 15 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 21 ------------------------------------------------------------ ---------- END OF REPORT ---------- ------------------------------------------------------------ NTP Experiment-Test: 05165-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC 4,4 THIOBIS-(6-T-BUTYL-M-CRESOL) Date: 11/10/95 Route: DOSED FEED Time: 16:32:54 Facility: Battelle Columbus Laboratory Chemical CAS #: 96-69-5 Lock Date: None 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: 05165-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC 4,4 THIOBIS-(6-T-BUTYL-M-CRESOL) Date: 11/10/95 Route: DOSED FEED Time: 16:32:54 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 PPM 0 PPM 500 PPM 500 PPM 1000 PPM 1000 PPM NEURO HCU NEURO HCU NEURO HCU ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially in Study 40 15 40 15 40 15 Scheduled Sacrifice 40 15 40 15 40 12 Early Deaths Natural Death 2 Moribund Sacrifice 1 Survivors Animals Examined Microscopically 20 20 20 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM None ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM None ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM None ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM None ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM None ____________________________________________________________________________________________________________________________________ Page 2 NTP Experiment-Test: 05165-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC 4,4 THIOBIS-(6-T-BUTYL-M-CRESOL) Date: 11/10/95 Route: DOSED FEED Time: 16:32:54 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 PPM 0 PPM 500 PPM 500 PPM 1000 PPM 1000 PPM NEURO HCU NEURO HCU NEURO HCU ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM None ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM None ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM None ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM None ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM None ____________________________________________________________________________________________________________________________________ URINARY SYSTEM None Page 3 NTP Experiment-Test: 05165-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC 4,4 THIOBIS-(6-T-BUTYL-M-CRESOL) Date: 11/10/95 Route: DOSED FEED Time: 16:32:54 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 2500 PPM 2500 PPM NEURO HCU ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially in Study 40 15 Scheduled Sacrifice 40 14 Early Deaths Moribund Sacrifice 1 Survivors Animals Examined Microscopically 20 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM None ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM None ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM None ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM None ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM None ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM None ____________________________________________________________________________________________________________________________________ Page 4 NTP Experiment-Test: 05165-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC 4,4 THIOBIS-(6-T-BUTYL-M-CRESOL) Date: 11/10/95 Route: DOSED FEED Time: 16:32:54 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 2500 PPM 2500 PPM NEURO HCU ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM None ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM None ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM None ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM None ____________________________________________________________________________________________________________________________________ URINARY SYSTEM None Page 5 ------------------------------------------------------------ ---------- END OF REPORT ---------- ------------------------------------------------------------