TDMS Study 93023-06 Pathology Tables
NTP Experiment-Test: 93023-06 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC 2,4-HEXADIENAL Date: 03/14/01 Route: GAVAGE Time: 15:12:24 FINAL#1/RATS Facility: Southern Research Institute Chemical CAS #: 142-83-6 Lock Date: 02/28/00 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: 93023-06 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC 2,4-HEXADIENAL Date: 03/14/01 Route: GAVAGE Time: 15:12:24 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 22.5 45 90 MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially in Study 50 50 50 50 Early Deaths Moribund Sacrifice 12 9 6 9 Natural Death 1 1 2 4 Dosing Accident 1 1 6 Survivors Terminal Sacrifice 37 38 41 31 Natural Death 1 Animals Examined Microscopically 50 50 50 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Colon (50) (50) (49) (50) Intestine Large, Rectum (49) (50) (50) (49) Intestine Large, Cecum (50) (50) (50) (50) Intestine Small, Duodenum (50) (49) (50) (50) Leiomyoma 1 (2%) Liver (50) (50) (50) (50) Mesentery (13) (16) (19) (15) Oral Mucosa (1) Squamous Cell Papilloma 1 (100%) Pancreas (50) (50) (50) (50) Acinus, Adenoma 1 (2%) 1 (2%) Salivary Glands (50) (50) (50) (50) Stomach, Forestomach (50) (49) (50) (50) Squamous Cell Papilloma 1 (2%) 4 (8%) 16 (32%) Squamous Cell Papilloma, Multiple 1 (2%) 1 (2%) Stomach, Glandular (50) (49) (50) (50) Tongue (1) (2) (1) Squamous Cell Carcinoma 1 (50%) Squamous Cell Papilloma 1 (50%) 1 (100%) Tooth (1) Odontogenic Tumor 1 (100%) ____________________________________________________________________________________________________________________________________ Page 2 NTP Experiment-Test: 93023-06 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC 2,4-HEXADIENAL Date: 03/14/01 Route: GAVAGE Time: 15:12:24 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 22.5 45 90 MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (50) (50) (50) (50) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (50) (50) (50) (50) Adenoma 1 (2%) 1 (2%) Adrenal Medulla (50) (49) (50) (50) Pheochromocytoma Malignant 1 (2%) 1 (2%) Pheochromocytoma Complex 1 (2%) Pheochromocytoma Benign 1 (2%) 5 (10%) 5 (10%) 1 (2%) Islets, Pancreatic (50) (50) (50) (50) Adenoma 1 (2%) 1 (2%) 1 (2%) Carcinoma 1 (2%) Pituitary Gland (50) (50) (50) (50) Pars Distalis, Adenoma 19 (38%) 26 (52%) 22 (44%) 20 (40%) Pars Intermedia, Adenoma 1 (2%) 1 (2%) Thyroid Gland (50) (50) (50) (50) Bilateral, C-Cell, Adenoma 1 (2%) C-Cell, Adenoma 11 (22%) 6 (12%) 7 (14%) 6 (12%) C-Cell, Carcinoma 1 (2%) 1 (2%) 1 (2%) Follicular Cell, Carcinoma 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM Peritoneum (1) ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Clitoral Gland (50) (50) (50) (50) Adenoma 5 (10%) 8 (16%) 11 (22%) 7 (14%) Carcinoma 2 (4%) 1 (2%) 3 (6%) 3 (6%) Ovary (50) (50) (50) (50) Thecoma Malignant 1 (2%) Uterus (50) (50) (50) (50) Adenoma 1 (2%) Carcinoma 1 (2%) Deciduoma Benign 1 (2%) Polyp Stromal 14 (28%) 11 (22%) 9 (18%) 13 (26%) Sarcoma Stromal 1 (2%) Page 3 NTP Experiment-Test: 93023-06 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC 2,4-HEXADIENAL Date: 03/14/01 Route: GAVAGE Time: 15:12:24 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 22.5 45 90 MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM - cont Vagina (1) (3) (1) (1) Sarcoma 1 (33%) Sarcoma Stromal, Metastatic, Uterus 1 (100%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (50) (50) (50) (50) Lymph Node (29) (30) (30) (38) Fibrosarcoma, Metastatic, Skin 1 (3%) Deep Cervical, Carcinoma, Metastatic, Thyroid Gland 1 (3%) Lymph Node, Mandibular (6) (2) (5) (1) Lymph Node, Mesenteric (50) (50) (50) (50) Spleen (50) (50) (50) (50) Thymus (48) (47) (50) (50) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (50) (50) (50) (50) Adenoma 2 (4%) Carcinoma 2 (4%) 3 (6%) 1 (2%) Fibroadenoma 22 (44%) 28 (56%) 22 (44%) 18 (36%) Schwannoma Benign 1 (2%) Skin (49) (49) (50) (50) Basal Cell Adenoma 1 (2%) Fibrous Histiocytoma 1 (2%) Keratoacanthoma 1 (2%) Neural Crest Tumor 1 (2%) Pinna, Neural Crest Tumor 1 (2%) Subcutaneous Tissue, Fibroma 2 (4%) 1 (2%) 2 (4%) Subcutaneous Tissue, Fibrosarcoma 1 (2%) 1 (2%) Subcutaneous Tissue, Schwannoma Malignant 2 (4%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (50) (50) (50) (50) Osteosarcoma 1 (2%) ____________________________________________________________________________________________________________________________________ Page 4 NTP Experiment-Test: 93023-06 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC 2,4-HEXADIENAL Date: 03/14/01 Route: GAVAGE Time: 15:12:24 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 22.5 45 90 MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (50) (50) (50) Astrocytoma Malignant 2 (4%) Glioma Malignant 1 (2%) Oligodendroglioma Malignant 1 (2%) Spinal Cord (3) (1) Astrocytoma Malignant, Metastatic, Brain 1 (33%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (50) (50) (50) Alveolar/Bronchiolar Adenoma 3 (6%) 1 (2%) 1 (2%) Alveolar/Bronchiolar Carcinoma 1 (2%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Zymbal's Gland (1) Carcinoma 1 (100%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (50) (50) (50) Renal Tubule, Carcinoma 1 (2%) Urinary Bladder (50) (50) (50) (50) Papilloma 1 (2%) ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS Multiple Organs *(50) *(50) *(50) *(50) Leukemia Mononuclear 10 (20%) 11 (22%) 5 (10%) 16 (32%) Mesothelioma Malignant 1 (2%) ____________________________________________________________________________________________________________________________________ * Number of animals with any tissue examined microscopically Page 5 NTP Experiment-Test: 93023-06 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC 2,4-HEXADIENAL Date: 03/14/01 Route: GAVAGE Time: 15:12:24 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 22.5 45 90 MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY ____________________________________________________________________________________________________________________________________ TUMOR SUMMARY Total Animals with Primary Neoplasms (b) 48 48 48 44 Total Primary Neoplasms 109 112 106 113 Total Animals with Benign Neoplasms 45 45 43 44 Total Benign Neoplasms 86 89 88 89 Total Animals with Malignant Neoplasms 18 19 14 21 Total Malignant Neoplasms 22 23 16 24 Total Animals with Metastatic Neoplasms 1 1 1 1 Total Metastatic Neoplasm 1 1 1 1 Total Animals with Malignant Neoplasms Uncertain Primary Site Total Animals with Neoplasms Uncertain- Benign or Malignant 1 2 Total Uncertain Neoplasms 1 2 ____________________________________________________________________________________________________________________________________ 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: 93023-06 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC 2,4-HEXADIENAL Date: 03/14/01 Route: GAVAGE Time: 15:12:24 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 22.5 45 90 MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially in Study 50 50 50 50 Early Deaths Moribund Sacrifice 10 11 13 10 Dosing Accident 1 2 1 5 Natural Death 2 2 3 5 Survivors Terminal Sacrifice 37 35 33 30 Animals Examined Microscopically 50 50 50 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Colon (48) (49) (50) (50) Carcinoma 1 (2%) Intestine Large, Cecum (50) (50) (50) (50) Intestine Small, Duodenum (50) (50) (50) (50) Intestine Small, Jejunum (49) (50) (50) (47) Intestine Small, Ileum (49) (49) (50) (50) Liver (50) (50) (50) (50) Hepatocellular Carcinoma 1 (2%) Histiocytic Sarcoma 1 (2%) 1 (2%) 1 (2%) Mesentery (13) (8) (19) (17) Hemangiosarcoma 1 (6%) Oral Mucosa (1) (1) (1) (1) Squamous Cell Carcinoma 1 (100%) Squamous Cell Papilloma 1 (100%) 1 (100%) Pancreas (50) (50) (50) (50) Acinus, Adenoma 10 (20%) 5 (10%) 9 (18%) 6 (12%) Salivary Glands (50) (50) (50) (50) Schwannoma Malignant 1 (2%) Stomach, Forestomach (50) (50) (50) (50) Lipoma 1 (2%) Squamous Cell Carcinoma 1 (2%) 2 (4%) Squamous Cell Papilloma 3 (6%) 10 (20%) 18 (36%) Squamous Cell Papilloma, Multiple 11 (22%) Stomach, Glandular (50) (50) (50) (50) Tongue (2) (1) (2) (1) Squamous Cell Carcinoma 1 (50%) Squamous Cell Papilloma 1 (100%) ____________________________________________________________________________________________________________________________________ Page 7 NTP Experiment-Test: 93023-06 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC 2,4-HEXADIENAL Date: 03/14/01 Route: GAVAGE Time: 15:12:24 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 22.5 45 90 MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (50) (50) (50) (50) Schwannoma Malignant 1 (2%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (50) (50) (50) (50) Adenoma 1 (2%) Adrenal Medulla (50) (49) (50) (49) Pheochromocytoma Malignant 1 (2%) 1 (2%) 4 (8%) Pheochromocytoma Complex 1 (2%) 1 (2%) Pheochromocytoma Benign 7 (14%) 6 (12%) 7 (14%) 7 (14%) Islets, Pancreatic (50) (50) (50) (50) Adenoma 4 (8%) 6 (12%) 5 (10%) 1 (2%) Carcinoma 2 (4%) 1 (2%) Pituitary Gland (50) (50) (50) (50) Pars Distalis, Adenoma 12 (24%) 16 (32%) 15 (30%) 19 (38%) Thyroid Gland (50) (50) (50) (50) Bilateral, C-Cell, Adenoma 1 (2%) 1 (2%) C-Cell, Adenoma 4 (8%) 4 (8%) 5 (10%) 6 (12%) C-Cell, Carcinoma 1 (2%) 1 (2%) 4 (8%) Follicular Cell, Carcinoma 1 (2%) 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM Peritoneum (4) (1) (1) ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Preputial Gland (49) (50) (50) (50) Adenoma 1 (2%) 4 (8%) 1 (2%) Carcinoma 3 (6%) 3 (6%) 5 (10%) 1 (2%) Prostate (49) (47) (50) (50) Ventral, Adenoma 2 (4%) 2 (4%) 3 (6%) 3 (6%) Seminal Vesicle (50) (50) (50) (50) Testes (50) (50) (50) (50) Bilateral, Interstitial Cell, Adenoma 35 (70%) 36 (72%) 32 (64%) 40 (80%) Interstitial Cell, Adenoma 6 (12%) 9 (18%) 13 (26%) 6 (12%) ____________________________________________________________________________________________________________________________________ Page 8 NTP Experiment-Test: 93023-06 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC 2,4-HEXADIENAL Date: 03/14/01 Route: GAVAGE Time: 15:12:24 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 22.5 45 90 MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (50) (50) (50) (50) Lymph Node (21) (27) (29) (28) Deep Cervical, Carcinoma, Metastatic, Zymbal's Gland 1 (4%) Mediastinal, Carcinoma, Metastatic, Thyroid Gland 1 (4%) Pancreatic, Histiocytic Sarcoma 1 (3%) Lymph Node, Mandibular (8) (1) (3) (2) Lymph Node, Mesenteric (50) (50) (50) (50) Spleen (50) (50) (50) (50) Histiocytic Sarcoma 1 (2%) Pheochromocytoma Malignant, Metastatic, Adrenal Medulla 1 (2%) Thymus (50) (49) (50) (49) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (48) (45) (46) (44) Carcinoma 2 (4%) Fibroadenoma 3 (6%) 1 (2%) 1 (2%) 2 (5%) Skin (50) (50) (50) (50) Basal Cell Adenoma 1 (2%) Basal Cell Carcinoma 1 (2%) Histiocytic Sarcoma 1 (2%) 1 (2%) 1 (2%) Keratoacanthoma 3 (6%) 2 (4%) 1 (2%) 1 (2%) Neural Crest Tumor 1 (2%) 1 (2%) Squamous Cell Papilloma 1 (2%) 1 (2%) Trichoepithelioma 1 (2%) Pinna, Neural Crest Tumor 1 (2%) 1 (2%) Sebaceous Gland, Adenoma 1 (2%) 1 (2%) Subcutaneous Tissue, Fibroma 4 (8%) 3 (6%) 6 (12%) 5 (10%) Subcutaneous Tissue, Fibrosarcoma 3 (6%) 1 (2%) 1 (2%) Subcutaneous Tissue, Hemangiopericytoma 1 (2%) Subcutaneous Tissue, Hemangiosarcoma 1 (2%) Subcutaneous Tissue, Lipoma 1 (2%) 1 (2%) Subcutaneous Tissue, Schwannoma Malignant 1 (2%) ____________________________________________________________________________________________________________________________________ Page 9 NTP Experiment-Test: 93023-06 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC 2,4-HEXADIENAL Date: 03/14/01 Route: GAVAGE Time: 15:12:24 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 22.5 45 90 MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (50) (50) (50) (50) Osteosarcoma 1 (2%) 1 (2%) 1 (2%) Skeletal Muscle (1) (6) (1) (3) Sarcoma 1 (17%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (50) (50) (50) Astrocytoma Malignant 1 (2%) Spinal Cord (2) (4) (1) (2) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (50) (50) (50) Alveolar/Bronchiolar Adenoma 1 (2%) 4 (8%) 1 (2%) Alveolar/Bronchiolar Carcinoma 3 (6%) 1 (2%) Carcinoma, Metastatic, Preputial Gland 1 (2%) Carcinoma, Metastatic, Zymbal's Gland 1 (2%) 1 (2%) Histiocytic Sarcoma 1 (2%) 1 (2%) 1 (2%) Osteosarcoma, Metastatic, Bone 1 (2%) Pheochromocytoma Malignant, Metastatic, Adrenal Medulla 1 (2%) Squamous Cell Carcinoma 1 (2%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Zymbal's Gland (2) (1) (2) Adenoma 1 (50%) Carcinoma 1 (50%) 1 (100%) 2 (100%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (50) (50) (50) Histiocytic Sarcoma 1 (2%) Renal Tubule, Carcinoma 1 (2%) Transitional Epithelium, Carcinoma 1 (2%) Urinary Bladder (50) (50) (50) (50) Page 10 NTP Experiment-Test: 93023-06 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC 2,4-HEXADIENAL Date: 03/14/01 Route: GAVAGE Time: 15:12:24 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 22.5 45 90 MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS Multiple Organs *(50) *(50) *(50) *(50) Histiocytic Sarcoma 1 (2%) 1 (2%) 1 (2%) 1 (2%) Leukemia Mononuclear 11 (22%) 14 (28%) 9 (18%) 17 (34%) Mesothelioma Malignant 4 (8%) 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ * Number of animals with any tissue examined microscopically Page 11 NTP Experiment-Test: 93023-06 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC 2,4-HEXADIENAL Date: 03/14/01 Route: GAVAGE Time: 15:12:24 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 22.5 45 90 MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY ____________________________________________________________________________________________________________________________________ TUMOR SUMMARY Total Animals with Primary Neoplasms (b) 50 48 50 47 Total Primary Neoplasms 128 132 147 170 Total Animals with Benign Neoplasms 48 47 49 46 Total Benign Neoplasms 99 100 117 128 Total Animals with Malignant Neoplasms 21 23 24 30 Total Malignant Neoplasms 28 31 30 40 Total Animals with Metastatic Neoplasms 1 3 1 2 Total Metastatic Neoplasm 1 3 3 4 Total Animals with Malignant Neoplasms Uncertain Primary Site Total Animals with Neoplasms Uncertain- Benign or Malignant 1 1 2 Total Uncertain Neoplasms 1 1 2 ____________________________________________________________________________________________________________________________________ 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 ---------- ------------------------------------------------------------