TDMS Study 05165-02 Pathology Tables
NTP Experiment-Test: 05165-02 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: 16:17:28 Facility: Battelle Columbus Laboratory Chemical CAS #: 96-69-5 Lock Date: 01/10/92 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: 05165-02 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: 16:17:28 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0 PPM 250 PPM 500 PPM 1000 PPM ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially in Study 60 60 60 60 Scheduled Sacrifice 9 9 10 10 Early Deaths Natural Death 7 9 11 11 Moribund Sacrifice 4 3 3 4 Survivors Natural Death 1 Terminal Sacrifice 39 38 36 35 Missing 1 Animals Examined Microscopically 60 59 60 60 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Esophagus (59) (59) (60) (60) Gallbladder (59) (57) (58) (57) Intestine Large, Colon (59) (59) (60) (60) Leiomyosarcoma 1 (2%) Intestine Large, Rectum (59) (59) (60) (60) Intestine Large, Cecum (59) (59) (60) (60) Intestine Small, Duodenum (59) (59) (60) (60) Intestine Small, Jejunum (59) (59) (60) (60) Serosa, Fibrosarcoma, Metastatic, Skin 1 (2%) Liver (60) (59) (60) (60) Fibrosarcoma, Metastatic, Skin 1 (2%) Fibrous Histiocytoma, Multiple, Metastatic, Mesentery 1 (2%) Hepatocellular Carcinoma 3 (5%) 7 (12%) 7 (12%) 4 (7%) Hepatocellular Carcinoma, Multiple 1 (2%) 1 (2%) 1 (2%) Hepatocellular Adenoma 14 (23%) 11 (19%) 11 (18%) 10 (17%) Hepatocellular Adenoma, Multiple 6 (10%) 7 (12%) 7 (12%) 1 (2%) Histiocytic Sarcoma 1 (2%) 1 (2%) Histiocytic Sarcoma, Metastatic, Uterus 1 (2%) Mesentery (5) (6) (4) (1) Fibrous Histiocytoma 1 (17%) Fat, Fibrosarcoma, Metastatic, Skin 1 (17%) Fat, Granulosa-Theca Tumor Malignant, Metastatic, Ovary 1 (20%) Fat, Histiocytic Sarcoma, Metastatic, Uterus 1 (25%) Pancreas (59) (59) (59) (60) Fibrous Histiocytoma, Metastatic, Mesentery 1 (2%) Histiocytic Sarcoma, Metastatic, Uterus 1 (2%) Serosa, Fibrosarcoma, Metastatic, Skin 1 (2%) Page 2 NTP Experiment-Test: 05165-02 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: 16:17:28 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0 PPM 250 PPM 500 PPM 1000 PPM ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - cont Salivary Glands (60) (59) (57) (60) Stomach, Forestomach (59) (59) (60) (60) Histiocytic Sarcoma, Metastatic, Uterus 1 (2%) Squamous Cell Papilloma 2 (3%) Stomach, Glandular (59) (59) (60) (60) Fibrous Histiocytoma, Metastatic, Uncertain Primary Site 1 (2%) Histiocytic Sarcoma, Metastatic, Uterus 1 (2%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (60) (59) (60) (60) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (60) (59) (60) (60) Sarcoma, Metastatic, Kidney 1 (2%) Capsule, Fibrosarcoma, Metastatic, Skin 1 (2%) Capsule, Spindle Cell, Adenoma 1 (2%) Spindle Cell, Subcapsular, Adenoma 1 (2%) 1 (2%) Adrenal Medulla (58) (59) (60) (60) Pheochromocytoma Benign 2 (3%) 2 (3%) 2 (3%) Bilateral, Pheochromocytoma Malignant 1 (2%) Pituitary Gland (57) (58) (59) (58) Pars Distalis, Adenoma 5 (9%) 6 (10%) 9 (15%) 4 (7%) Pars Distalis, Adenoma, Multiple 1 (2%) Pars Intermedia, Adenoma 1 (2%) 1 (2%) Pars Intermedia, Carcinoma 1 (2%) Thyroid Gland (60) (59) (59) (60) Follicular Cell, Adenoma 1 (2%) 2 (3%) 1 (2%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM Tissue NOS (1) (1) Fibrosarcoma 1 (100%) ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Ovary (59) (59) (59) (60) Cystadenoma 3 (5%) 3 (5%) 2 (3%) Granulosa-Theca Tumor Malignant 1 (2%) 1 (2%) Histiocytic Sarcoma 1 (2%) Histiocytic Sarcoma, Metastatic, Uterus 1 (2%) Page 3 NTP Experiment-Test: 05165-02 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: 16:17:28 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0 PPM 250 PPM 500 PPM 1000 PPM ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM - cont Luteoma 2 (3%) Sarcoma 1 (2%) Teratoma Benign 2 (3%) Thecoma Benign 1 (2%) Periovarian Tissue, Histiocytic Sarcoma 1 (2%) Uterus (60) (59) (60) (60) Hemangiosarcoma 1 (2%) Histiocytic Sarcoma 1 (2%) 3 (5%) Leiomyosarcoma 1 (2%) Polyp Stromal 2 (3%) 1 (2%) Sarcoma Stromal 1 (2%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (60) (59) (60) (60) Femoral, Hemangiosarcoma 1 (2%) 1 (2%) Lymph Node (9) (7) (4) (7) Lumbar, Fibrous Histiocytoma, Metastatic, Uncertain Primary Site 1 (25%) Mediastinal, Fibrous Histiocytoma, Metastatic, Mesentery 1 (14%) Mediastinal, Fibrous Histiocytoma, Metastatic, Uncertain Primary Site 1 (25%) Mediastinal, Histiocytic Sarcoma 1 (11%) Pancreatic, Histiocytic Sarcoma 1 (11%) Pancreatic, Histiocytic Sarcoma, Metastatic, Uterus 1 (25%) Renal, Fibrous Histiocytoma, Metastatic, Uncertain Primary Site 1 (25%) Renal, Granulosa-Theca Tumor Malignant, Metastatic, Ovary 1 (11%) 1 (14%) Renal, Sarcoma, Metastatic, Kidney 1 (14%) Lymph Node, Mandibular (59) (59) (57) (60) Granulosa-Theca Tumor Malignant, Metastatic, Ovary 1 (2%) Lymph Node, Mesenteric (52) (51) (51) (52) Fibrosarcoma, Metastatic, Skin 1 (2%) Fibrous Histiocytoma, Metastatic, Uncertain Primary Site 1 (2%) Granulosa-Theca Tumor Malignant, Metastatic, Ovary 1 (2%) Histiocytic Sarcoma 1 (2%) Histiocytic Sarcoma, Metastatic, Uterus 1 (2%) Spleen (60) (59) (60) (59) Hemangiosarcoma 2 (3%) 1 (2%) 1 (2%) Thymus (55) (52) (54) (58) Page 4 NTP Experiment-Test: 05165-02 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: 16:17:28 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0 PPM 250 PPM 500 PPM 1000 PPM ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - cont ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (59) (59) (58) (59) Adenocarcinoma, Multiple 1 (2%) Skin (60) (59) (60) (60) Sebaceous Gland, Adenoma 1 (2%) Subcutaneous Tissue, Fibrosarcoma 2 (3%) 2 (3%) 3 (5%) 1 (2%) Subcutaneous Tissue, Fibrosarcoma, Metastatic, Skin 1 (2%) Subcutaneous Tissue, Fibrous Histiocytoma, Metastatic, Uncertain Primary Site 1 (2%) Subcutaneous Tissue, Hemangioma 2 (3%) Subcutaneous Tissue, Hemangiosarcoma 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Skeletal Muscle (60) (59) (60) (60) Diaphragm, Fibrous Histiocytoma, Metastatic, Mesentery 1 (2%) Diaphragm, Granulosa-Theca Tumor Malignant, Metastatic, Ovary 1 (2%) Thigh, Fibrosarcoma, Metastatic, Skin 1 (2%) 1 (2%) Thigh, Histiocytic Sarcoma, Metastatic, Uterus 1 (2%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (60) (59) (60) (60) Histiocytic Sarcoma 1 (2%) Meninges, Cerebrum, Lipoma 1 (2%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (60) (59) (60) (60) Alveolar/Bronchiolar Adenoma 2 (3%) 3 (5%) 1 (2%) 3 (5%) Alveolar/Bronchiolar Carcinoma, Multiple 1 (2%) Fibrosarcoma, Metastatic, Skin 1 (2%) 1 (2%) Fibrous Histiocytoma, Metastatic, Mesentery 1 (2%) Fibrous Histiocytoma, Metastatic, Uncertain Primary Site 1 (2%) Granulosa-Theca Tumor Malignant, Metastatic, Ovary 1 (2%) Page 5 NTP Experiment-Test: 05165-02 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: 16:17:28 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0 PPM 250 PPM 500 PPM 1000 PPM ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM - cont Hepatocellular Carcinoma, Metastatic, Liver 1 (2%) 3 (5%) 3 (5%) Histiocytic Sarcoma 1 (2%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Ear (2) (1) Adenoma 1 (50%) Pinna, Fibroma 1 (50%) Eye (1) (1) (1) Adenocarcinoma, Metastatic, Harderian Gland 1 (100%) Harderian Gland (1) (3) (1) (1) Adenocarcinoma 1 (100%) 2 (67%) Adenoma 1 (33%) 1 (100%) 1 (100%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (60) (59) (60) (60) Histiocytic Sarcoma, Metastatic, Uterus 1 (2%) Sarcoma 1 (2%) Urinary Bladder (59) (59) (60) (60) ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS Multiple Organs *(60) *(59) *(60) *(60) Histiocytic Sarcoma 1 (2%) 4 (7%) Lymphoma Malignant Histiocytic 1 (2%) 1 (2%) 1 (2%) 2 (3%) Lymphoma Malignant Lymphocytic 3 (5%) 2 (3%) 5 (8%) 5 (8%) Lymphoma Malignant Mixed 7 (12%) 4 (7%) 4 (7%) 1 (2%) Lymphoma Malignant Undifferentiated Cell 2 (3%) 1 (2%) ____________________________________________________________________________________________________________________________________ * Number of animals with any tissue examined microscopically Page 6 NTP Experiment-Test: 05165-02 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: 16:17:28 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0 PPM 250 PPM 500 PPM 1000 PPM ____________________________________________________________________________________________________________________________________ TUMOR SUMMARY Total Animals with Primary Neoplasms (b) 41 38 39 41 Total Primary Neoplasms 64 65 66 48 Total Animals with Benign Neoplasms 30 31 25 25 Total Benign Neoplasms 37 38 39 29 Total Animals with Malignant Neoplasms 23 22 23 18 Total Malignant Neoplasms 27 27 27 19 Total Animals with Metastatic Neoplasms 5 6 6 2 Total Metastatic Neoplasm 8 16 21 5 Total Animals with Malignant Neoplasms 1 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: 05165-02 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: 16:17:28 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0 PPM 250 PPM 500 PPM 1000 PPM ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially in Study 60 60 60 60 Scheduled Sacrifice 10 10 10 10 Early Deaths Natural Death 6 6 1 4 Moribund Sacrifice 2 2 1 Survivors Natural Death 1 1 Terminal Sacrifice 41 41 49 45 Animals Examined Microscopically 60 60 60 60 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Gallbladder (60) (59) (60) (59) Intestine Small, Duodenum (60) (59) (59) (60) Polyp Adenomatous 1 (2%) Intestine Small, Jejunum (60) (60) (60) (60) Adenocarcinoma 1 (2%) Liver (60) (60) (60) (60) Hemangiosarcoma 1 (2%) Hepatocellular Carcinoma 8 (13%) 9 (15%) 7 (12%) 3 (5%) Hepatocellular Carcinoma, Multiple 3 (5%) 2 (3%) 3 (5%) 1 (2%) Hepatocellular Adenoma 11 (18%) 13 (22%) 20 (33%) 10 (17%) Hepatocellular Adenoma, Multiple 6 (10%) 11 (18%) 6 (10%) 4 (7%) Mesentery (1) (2) (1) Pancreas (60) (60) (60) (60) Salivary Glands (60) (60) (60) (60) Stomach, Forestomach (60) (60) (60) (60) Squamous Cell Papilloma 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM None ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (60) (60) (60) (60) Bilateral, Spindle Cell, Subcapsular, Adenoma 1 (2%) 1 (2%) Capsule, Spindle Cell, Adenoma 1 (2%) Spindle Cell, Subcapsular, Adenoma 11 (18%) 6 (10%) 6 (10%) 6 (10%) Adrenal Medulla (60) (60) (60) (60) Page 8 NTP Experiment-Test: 05165-02 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: 16:17:28 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0 PPM 250 PPM 500 PPM 1000 PPM ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM - cont Pheochromocytoma Malignant 1 (2%) Islets, Pancreatic (60) (60) (60) (60) Adenoma 1 (2%) Carcinoma 1 (2%) Pituitary Gland (55) (56) (58) (57) Pars Distalis, Adenoma 1 (2%) Thyroid Gland (60) (60) (60) (60) Adenocarcinoma 1 (2%) C-Cell, Adenoma 1 (2%) Follicular Cell, Adenoma 1 (2%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Testes (60) (60) (60) (60) Interstitial Cell, Adenoma 1 (2%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (60) (60) (60) (58) Femoral, Hemangiosarcoma 1 (2%) 1 (2%) Lymph Node (1) (1) (2) Inguinal, Hemangioma 1 (100%) Lymph Node, Mandibular (59) (57) (57) (58) Lymph Node, Mesenteric (58) (55) (58) (55) Fibrosarcoma, Metastatic, Uncertain Primary Site 1 (2%) Spleen (60) (60) (60) (60) Hemangioma 1 (2%) Hemangiosarcoma 1 (2%) 1 (2%) 1 (2%) Thymus (56) (56) (56) (54) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM None ____________________________________________________________________________________________________________________________________ Page 9 NTP Experiment-Test: 05165-02 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: 16:17:28 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0 PPM 250 PPM 500 PPM 1000 PPM ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM None ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM None ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (60) (60) (60) (60) Adenocarcinoma, Metastatic, Harderian Gland 2 (3%) Alveolar/Bronchiolar Adenoma 5 (8%) 7 (12%) 9 (15%) 3 (5%) Alveolar/Bronchiolar Adenoma, Multiple 2 (3%) 1 (2%) Alveolar/Bronchiolar Carcinoma 3 (5%) 2 (3%) 1 (2%) Fibrosarcoma, Metastatic, Uncertain Primary Site 1 (2%) Hepatocellular Carcinoma, Metastatic, Liver 3 (5%) 4 (7%) 4 (7%) 1 (2%) Nose (60) (60) (60) (58) Adenocarcinoma, Metastatic, Harderian Gland 1 (2%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Ear (1) (1) Pinna, Fibroma 1 (100%) Pinna, Trichoepithelioma 1 (100%) Eye (2) (2) (1) Adenocarcinoma, Metastatic, Harderian Gland 1 (50%) Harderian Gland (3) (4) (3) Adenocarcinoma 2 (67%) 1 (33%) Adenoma 1 (33%) 3 (75%) 2 (67%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (60) (60) (60) (60) Artery, Fibrosarcoma, Metastatic, Uncertain Primary Site 1 (2%) Page 10 NTP Experiment-Test: 05165-02 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: 16:17:28 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0 PPM 250 PPM 500 PPM 1000 PPM ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS Multiple Organs *(60) *(60) *(60) *(60) Lymphoma Malignant Histiocytic 1 (2%) 1 (2%) Lymphoma Malignant Lymphocytic 1 (2%) 1 (2%) Lymphoma Malignant Mixed 2 (3%) 3 (5%) 3 (5%) Lymphoma Malignant Undifferentiated Cell 1 (2%) ____________________________________________________________________________________________________________________________________ * Number of animals with any tissue examined microscopically Page 11 NTP Experiment-Test: 05165-02 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: 16:17:28 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0 PPM 250 PPM 500 PPM 1000 PPM ____________________________________________________________________________________________________________________________________ TUMOR SUMMARY Total Animals with Primary Neoplasms (b) 39 41 45 27 Total Primary Neoplasms 62 61 67 36 Total Animals with Benign Neoplasms 31 32 38 20 Total Benign Neoplasms 41 45 49 23 Total Animals with Malignant Neoplasms 17 15 16 11 Total Malignant Neoplasms 21 16 18 13 Total Animals with Metastatic Neoplasms 5 5 4 1 Total Metastatic Neoplasm 7 7 4 1 Total Animals with Malignant Neoplasms 1 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 ---------- ------------------------------------------------------------