TDMS Study 88122-06 Pathology Tables
NTP Experiment-Test: 88122-06 NEOPLASMS BY INDIVIDUAL ANIMAL (SYSTEMIC LESIONS ABRIDGED) Report: PEIRPT17 Study Type: CHRONIC ELMIRON Date: 06/12/01 Route: GAVAGE Time: 09:26:59 FINAL#1 Facility: Battelle Columbus Laboratory Chemical CAS #: 37319-17-8 Lock Date: 06/01/00 Cage Range: All Reasons For Removal: All Removal Date Range: All Treatment Groups: Include All Note: Animals arranged according to days on test Page 1 NTP Experiment-Test: 88122-06 NEOPLASMS BY INDIVIDUAL ANIMAL (SYSTEMIC LESIONS ABRIDGED) Report: PEIRPT17 Study Type: CHRONIC ELMIRON Date: 06/12/01 Route: GAVAGE Time: 09:26:59 _____________________________________________________________________________________________________________________ | 1| 4| 4| 4| 5| 5| 5| 5| 6| 6| 6| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 7| 7| 7| 7| DAY ON TEST | 9| 0| 2| 6| 0| 5| 9| 9| 0| 0| 2| 2| 5| 7| 7| 9| 0| 1| 2| 2| 2| 2| 2| 2| 2| | 1| 6| 7| 2| 9| 9| 6| 6| 0| 1| 1| 9| 1| 3| 8| 0| 7| 9| 2| 6| 8| 8| 9| 9| 9| __________________________________________|__________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| FISCHER 344 RATS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 0 MG/KG | 3| 2| 3| 5| 4| 3| 0| 1| 0| 4| 3| 2| 1| 3| 3| 3| 4| 1| 2| 0| 0| 3| 0| 0| 0| | 0| 0| 8| 0| 4| 1| 6| 2| 1| 6| 3| 3| 1| 4| 9| 7| 1| 8| 9| 3| 7| 2| 2| 4| 5| __________________________________________|__________________________________________________________________________| ALIMENTARY SYSTEM | | |__________________________________________________________________________| Esophagus | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Intestine Large, Colon | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Intestine Large, Rectum | + + A + A + + + + + + + A + + A + + + + + + + + +| |__________________________________________________________________________| Intestine Large, Cecum | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Intestine Small, Duodenum | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Intestine Small, Jejunum | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Intestine Small, Ileum | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Liver | + + + + + + + + + + + + + + + + + + + + + + + + +| Hepatocellular Carcinoma | X | Leiomyosarcoma, Metastatic, Uterus | X | |__________________________________________________________________________| Mesentery | + + | Liposarcoma | X | |__________________________________________________________________________| Pancreas | + + + + + + + + + + + + + + + + + + + + + + + + +| Adenoma | | |__________________________________________________________________________| Salivary Glands | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Stomach, Forestomach | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Stomach, Glandular | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Tongue | | _____________________________________________________________________________________________________________________| CARDIOVASCULAR SYSTEM | | |__________________________________________________________________________| Blood Vessel | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| __________________________________________|__________________________________________________________________________| Page 2 NTP Experiment-Test: 88122-06 NEOPLASMS BY INDIVIDUAL ANIMAL (SYSTEMIC LESIONS ABRIDGED) Report: PEIRPT17 Study Type: CHRONIC ELMIRON Date: 06/12/01 Route: GAVAGE Time: 09:26:59 _____________________________________________________________________________________________________________________ | 1| 4| 4| 4| 5| 5| 5| 5| 6| 6| 6| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 7| 7| 7| 7| DAY ON TEST | 9| 0| 2| 6| 0| 5| 9| 9| 0| 0| 2| 2| 5| 7| 7| 9| 0| 1| 2| 2| 2| 2| 2| 2| 2| | 1| 6| 7| 2| 9| 9| 6| 6| 0| 1| 1| 9| 1| 3| 8| 0| 7| 9| 2| 6| 8| 8| 9| 9| 9| __________________________________________|__________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| FISCHER 344 RATS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 0 MG/KG | 3| 2| 3| 5| 4| 3| 0| 1| 0| 4| 3| 2| 1| 3| 3| 3| 4| 1| 2| 0| 0| 3| 0| 0| 0| | 0| 0| 8| 0| 4| 1| 6| 2| 1| 6| 3| 3| 1| 4| 9| 7| 1| 8| 9| 3| 7| 2| 2| 4| 5| __________________________________________|__________________________________________________________________________| CARDIOVASCULAR SYSTEM - cont | | | | Heart | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| ENDOCRINE SYSTEM | | |__________________________________________________________________________| Adrenal Cortex | + + + + + + + + + + + + + + + + + + + + + + + + +| Adenoma | | |__________________________________________________________________________| Adrenal Medulla | + + + + + + + + + + + + + + + + + + + + + + + + +| Pheochromocytoma Benign | X | Bilateral, Pheochromocytoma Malignant| | |__________________________________________________________________________| Islets, Pancreatic | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Parathyroid Gland | + + + + + + + + + + + + + + + + + + + + + + + + M| Adenoma | | |__________________________________________________________________________| Pituitary Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| Pars Distalis, Adenoma | X X X X X X X X X X X X X | |__________________________________________________________________________| Thyroid Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| C-Cell, Adenoma | X X X X| Follicle, Carcinoma | | _____________________________________________________________________________________________________________________| GENERAL BODY SYSTEM | | None | | _____________________________________________________________________________________________________________________| GENITAL SYSTEM | | |__________________________________________________________________________| Clitoral Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| Adenoma | X | |__________________________________________________________________________| Ovary | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Uterus | + + + + + + + + + + + + + + + + + + + + + + + + +| Leiomyosarcoma | X | Polyp Stromal | X X X | __________________________________________|__________________________________________________________________________| Page 3 NTP Experiment-Test: 88122-06 NEOPLASMS BY INDIVIDUAL ANIMAL (SYSTEMIC LESIONS ABRIDGED) Report: PEIRPT17 Study Type: CHRONIC ELMIRON Date: 06/12/01 Route: GAVAGE Time: 09:26:59 _____________________________________________________________________________________________________________________ | 1| 4| 4| 4| 5| 5| 5| 5| 6| 6| 6| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 7| 7| 7| 7| DAY ON TEST | 9| 0| 2| 6| 0| 5| 9| 9| 0| 0| 2| 2| 5| 7| 7| 9| 0| 1| 2| 2| 2| 2| 2| 2| 2| | 1| 6| 7| 2| 9| 9| 6| 6| 0| 1| 1| 9| 1| 3| 8| 0| 7| 9| 2| 6| 8| 8| 9| 9| 9| __________________________________________|__________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| FISCHER 344 RATS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 0 MG/KG | 3| 2| 3| 5| 4| 3| 0| 1| 0| 4| 3| 2| 1| 3| 3| 3| 4| 1| 2| 0| 0| 3| 0| 0| 0| | 0| 0| 8| 0| 4| 1| 6| 2| 1| 6| 3| 3| 1| 4| 9| 7| 1| 8| 9| 3| 7| 2| 2| 4| 5| __________________________________________|__________________________________________________________________________| HEMATOPOIETIC SYSTEM | | |__________________________________________________________________________| Bone Marrow | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Lymph Node | + + | |__________________________________________________________________________| Lymph Node, Mandibular | M M M M M M M M M M M M M M M M M M M M + M M M M| |__________________________________________________________________________| Lymph Node, Mesenteric | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Spleen | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Thymus | + + + + + M + + + + + + + + + M + + + + + + + + +| _____________________________________________________________________________________________________________________| INTEGUMENTARY SYSTEM | | |__________________________________________________________________________| Mammary Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| Carcinoma | X | Fibroadenoma | X X X X X | Fibroadenoma, Multiple | X | |__________________________________________________________________________| Skin | + + + + + + + + + + + + + + + + + + + + + + + + +| Basal Cell Adenoma | | Subcutaneous Tissue, Fibroma | X | Subcutaneous Tissue, Lipoma | X | _____________________________________________________________________________________________________________________| MUSCULOSKELETAL SYSTEM | | |__________________________________________________________________________| Bone | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| NERVOUS SYSTEM | | |__________________________________________________________________________| Brain | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| RESPIRATORY SYSTEM | | |__________________________________________________________________________| Lung | + + + + + + + + + + + + + + + + + + + + + + + + +| Leiomyosarcoma, Metastatic, Uterus | X | __________________________________________|__________________________________________________________________________| Page 4 NTP Experiment-Test: 88122-06 NEOPLASMS BY INDIVIDUAL ANIMAL (SYSTEMIC LESIONS ABRIDGED) Report: PEIRPT17 Study Type: CHRONIC ELMIRON Date: 06/12/01 Route: GAVAGE Time: 09:26:59 _____________________________________________________________________________________________________________________ | 1| 4| 4| 4| 5| 5| 5| 5| 6| 6| 6| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 7| 7| 7| 7| DAY ON TEST | 9| 0| 2| 6| 0| 5| 9| 9| 0| 0| 2| 2| 5| 7| 7| 9| 0| 1| 2| 2| 2| 2| 2| 2| 2| | 1| 6| 7| 2| 9| 9| 6| 6| 0| 1| 1| 9| 1| 3| 8| 0| 7| 9| 2| 6| 8| 8| 9| 9| 9| __________________________________________|__________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| FISCHER 344 RATS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 0 MG/KG | 3| 2| 3| 5| 4| 3| 0| 1| 0| 4| 3| 2| 1| 3| 3| 3| 4| 1| 2| 0| 0| 3| 0| 0| 0| | 0| 0| 8| 0| 4| 1| 6| 2| 1| 6| 3| 3| 1| 4| 9| 7| 1| 8| 9| 3| 7| 2| 2| 4| 5| __________________________________________|__________________________________________________________________________| RESPIRATORY SYSTEM - cont | | | | Pheochromocytoma Malignant, | | Metastatic, Adrenal Medulla | | |__________________________________________________________________________| Nose | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Trachea | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| SPECIAL SENSES SYSTEM | | |__________________________________________________________________________| Zymbal's Gland | | Adenoma | | _____________________________________________________________________________________________________________________| URINARY SYSTEM | | |__________________________________________________________________________| Kidney | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Urinary Bladder | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________|__________________________________________________________________________| SYSTEMIC LESIONS | | __________________________________________________________________________| Multiple Organs | + + + + + + + + + + + + + + + + + + + + + + + + +| Leukemia Mononuclear | X X X X | __________________________________________|__________________________________________________________________________| Page 5 NTP Experiment-Test: 88122-06 NEOPLASMS BY INDIVIDUAL ANIMAL (SYSTEMIC LESIONS ABRIDGED) Report: PEIRPT17 Study Type: CHRONIC ELMIRON Date: 06/12/01 Route: GAVAGE Time: 09:26:59 __________________________________________________________________________________________________________________________________ | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| | DAY ON TEST | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| | | 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | __________________________________________|__________________________________________________________________________| T (*) | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| O | FISCHER 344 RATS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| T | ANIMAL ID | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| A | 0 MG/KG | 0| 0| 1| 1| 1| 2| 2| 3| 4| 4| 4| 4| 1| 1| 1| 1| 2| 2| 2| 2| 2| 3| 4| 4| 4| L | | 8| 9| 0| 6| 7| 2| 6| 5| 3| 5| 7| 9| 3| 4| 5| 9| 1| 4| 5| 7| 8| 6| 0| 2| 8| | _____________________________________________________________________________________________________________________|____________| ALIMENTARY SYSTEM | | | |__________________________________________________________________________|____________| Esophagus | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Intestine Large, Colon | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Intestine Large, Rectum | + + + + + + + + + + + + + + + + + + + + + + + + +| 46 | |__________________________________________________________________________|____________| Intestine Large, Cecum | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Intestine Small, Duodenum | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Intestine Small, Jejunum | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Intestine Small, Ileum | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Liver | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Hepatocellular Carcinoma | | 1 | Leiomyosarcoma, Metastatic, Uterus | | 1 | |__________________________________________________________________________|____________| Mesentery | + + + + + +| 8 | Liposarcoma | | 1 | |__________________________________________________________________________|____________| Pancreas | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Adenoma | X| 1 | |__________________________________________________________________________|____________| Salivary Glands | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Stomach, Forestomach | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Stomach, Glandular | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Tongue | + | 1 | _____________________________________________________________________________________________________________________| | * : Total animals with tissue examined microscopically; total animals with tumor + : Tissue examined microscopically M : Missing tissue X : Lesion present A : Autolysis precludes evaluation I : Insufficient tissue BLANK : Not examined microscopically Page 6 NTP Experiment-Test: 88122-06 NEOPLASMS BY INDIVIDUAL ANIMAL (SYSTEMIC LESIONS ABRIDGED) Report: PEIRPT17 Study Type: CHRONIC ELMIRON Date: 06/12/01 Route: GAVAGE Time: 09:26:59 __________________________________________________________________________________________________________________________________ | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| | DAY ON TEST | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| | | 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | __________________________________________|__________________________________________________________________________| T (*) | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| O | FISCHER 344 RATS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| T | ANIMAL ID | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| A | 0 MG/KG | 0| 0| 1| 1| 1| 2| 2| 3| 4| 4| 4| 4| 1| 1| 1| 1| 2| 2| 2| 2| 2| 3| 4| 4| 4| L | | 8| 9| 0| 6| 7| 2| 6| 5| 3| 5| 7| 9| 3| 4| 5| 9| 1| 4| 5| 7| 8| 6| 0| 2| 8| | _____________________________________________________________________________________________________________________|____________| CARDIOVASCULAR SYSTEM | | | |__________________________________________________________________________|____________| Blood Vessel | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Heart | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | _____________________________________________________________________________________________________________________| | ENDOCRINE SYSTEM | | | |__________________________________________________________________________|____________| Adrenal Cortex | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Adenoma | X | 1 | |__________________________________________________________________________|____________| Adrenal Medulla | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Pheochromocytoma Benign | X | 2 | Bilateral, Pheochromocytoma Malignant| X | 1 | |__________________________________________________________________________|____________| Islets, Pancreatic | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Parathyroid Gland | + + + + M + M + + + + + + + + + + + M + + + + + +| 46 | Adenoma | X | 1 | |__________________________________________________________________________|____________| Pituitary Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Pars Distalis, Adenoma | X X X X X X X X| 21 | |__________________________________________________________________________|____________| Thyroid Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | C-Cell, Adenoma | X X X X X X X | 11 | Follicle, Carcinoma | X | 1 | _____________________________________________________________________________________________________________________| | GENERAL BODY SYSTEM | | | None | | | _____________________________________________________________________________________________________________________| | GENITAL SYSTEM | | | |__________________________________________________________________________|____________| Clitoral Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Adenoma | X X | 3 | _____________________________________________________________________________________________________________________|____________| * : Total animals with tissue examined microscopically; total animals with tumor + : Tissue examined microscopically M : Missing tissue X : Lesion present A : Autolysis precludes evaluation I : Insufficient tissue BLANK : Not examined microscopically Page 7 NTP Experiment-Test: 88122-06 NEOPLASMS BY INDIVIDUAL ANIMAL (SYSTEMIC LESIONS ABRIDGED) Report: PEIRPT17 Study Type: CHRONIC ELMIRON Date: 06/12/01 Route: GAVAGE Time: 09:26:59 __________________________________________________________________________________________________________________________________ | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| | DAY ON TEST | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| | | 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | __________________________________________|__________________________________________________________________________| T (*) | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| O | FISCHER 344 RATS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| T | ANIMAL ID | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| A | 0 MG/KG | 0| 0| 1| 1| 1| 2| 2| 3| 4| 4| 4| 4| 1| 1| 1| 1| 2| 2| 2| 2| 2| 3| 4| 4| 4| L | | 8| 9| 0| 6| 7| 2| 6| 5| 3| 5| 7| 9| 3| 4| 5| 9| 1| 4| 5| 7| 8| 6| 0| 2| 8| | _____________________________________________________________________________________________________________________|____________| GENITAL SYSTEM - cont | | | | | | |__________________________________________________________________________|____________| Ovary | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Uterus | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Leiomyosarcoma | | 1 | Polyp Stromal | X X X X | 7 | _____________________________________________________________________________________________________________________| | HEMATOPOIETIC SYSTEM | | | |__________________________________________________________________________|____________| Bone Marrow | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Lymph Node | + + + + + | 7 | |__________________________________________________________________________|____________| Lymph Node, Mandibular | M M M M M M + M M M + M M M M M M M M M M M M M M| 3 | |__________________________________________________________________________|____________| Lymph Node, Mesenteric | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Spleen | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Thymus | + + M + + + + + + + + + + M + + + + + + M + + + +| 45 | _____________________________________________________________________________________________________________________| | INTEGUMENTARY SYSTEM | | | |__________________________________________________________________________|____________| Mammary Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Carcinoma | | 1 | Fibroadenoma | X X X X X X| 11 | Fibroadenoma, Multiple | X X X | 4 | |__________________________________________________________________________|____________| Skin | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Basal Cell Adenoma | X | 1 | Subcutaneous Tissue, Fibroma | | 1 | Subcutaneous Tissue, Lipoma | | 1 | _____________________________________________________________________________________________________________________|____________| * : Total animals with tissue examined microscopically; total animals with tumor + : Tissue examined microscopically M : Missing tissue X : Lesion present A : Autolysis precludes evaluation I : Insufficient tissue BLANK : Not examined microscopically Page 8 NTP Experiment-Test: 88122-06 NEOPLASMS BY INDIVIDUAL ANIMAL (SYSTEMIC LESIONS ABRIDGED) Report: PEIRPT17 Study Type: CHRONIC ELMIRON Date: 06/12/01 Route: GAVAGE Time: 09:26:59 __________________________________________________________________________________________________________________________________ | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| | DAY ON TEST | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| | | 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | __________________________________________|__________________________________________________________________________| T (*) | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| O | FISCHER 344 RATS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| T | ANIMAL ID | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| A | 0 MG/KG | 0| 0| 1| 1| 1| 2| 2| 3| 4| 4| 4| 4| 1| 1| 1| 1| 2| 2| 2| 2| 2| 3| 4| 4| 4| L | | 8| 9| 0| 6| 7| 2| 6| 5| 3| 5| 7| 9| 3| 4| 5| 9| 1| 4| 5| 7| 8| 6| 0| 2| 8| | _____________________________________________________________________________________________________________________|____________| MUSCULOSKELETAL SYSTEM | | | |__________________________________________________________________________|____________| Bone | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | _____________________________________________________________________________________________________________________| | NERVOUS SYSTEM | | | |__________________________________________________________________________|____________| Brain | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | _____________________________________________________________________________________________________________________| | RESPIRATORY SYSTEM | | | |__________________________________________________________________________|____________| Lung | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Leiomyosarcoma, Metastatic, Uterus | | 1 | Pheochromocytoma Malignant, | | | Metastatic, Adrenal Medulla | X | 1 | |__________________________________________________________________________|____________| Nose | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Trachea | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | _____________________________________________________________________________________________________________________| | SPECIAL SENSES SYSTEM | | | |__________________________________________________________________________|____________| Zymbal's Gland | + | 1 | Adenoma | X | 1 | _____________________________________________________________________________________________________________________| | URINARY SYSTEM | | | |__________________________________________________________________________|____________| Kidney | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Urinary Bladder | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | __________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS | | | __________________________________________________________________________|____________| Multiple Organs | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Leukemia Mononuclear | X X X | 7 | __________________________________________________________________________________________________________________________________ * : Total animals with tissue examined microscopically; total animals with tumor + : Tissue examined microscopically M : Missing tissue X : Lesion present A : Autolysis precludes evaluation I : Insufficient tissue BLANK : Not examined microscopically Page 9 NTP Experiment-Test: 88122-06 NEOPLASMS BY INDIVIDUAL ANIMAL (SYSTEMIC LESIONS ABRIDGED) Report: PEIRPT17 Study Type: CHRONIC ELMIRON Date: 06/12/01 Route: GAVAGE Time: 09:26:59 _____________________________________________________________________________________________________________________ | 1| 3| 4| 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| DAY ON TEST | 9| 3| 7| 1| 2| 3| 8| 9| 2| 5| 7| 7| 7| 7| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 2| | 7| 3| 4| 0| 6| 9| 9| 4| 2| 3| 0| 7| 8| 8| 4| 5| 6| 6| 9| 8| 8| 8| 8| 8| 8| __________________________________________|__________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| FISCHER 344 RATS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 28 MG/KG | 9| 6| 9| 8| 8| 6| 6| 9| 6| 8| 5| 9| 8| 9| 5| 6| 6| 8| 9| 5| 5| 6| 7| 7| 8| | 2| 9| 0| 7| 9| 6| 8| 5| 1| 4| 8| 8| 3| 9| 4| 5| 0| 8| 3| 5| 7| 4| 3| 6| 5| __________________________________________|__________________________________________________________________________| ALIMENTARY SYSTEM | | |__________________________________________________________________________| Esophagus | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Intestine Large, Colon | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Intestine Large, Rectum | + A + + A + A + + A A A + + + A + + + + + + + + +| |__________________________________________________________________________| Intestine Large, Cecum | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Intestine Small, Duodenum | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Intestine Small, Jejunum | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Intestine Small, Ileum | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Liver | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Mesentery | + + + | |__________________________________________________________________________| Oral Mucosa | | |__________________________________________________________________________| Pancreas | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Salivary Glands | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Stomach, Forestomach | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Stomach, Glandular | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| CARDIOVASCULAR SYSTEM | | |__________________________________________________________________________| Blood Vessel | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Heart | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| ENDOCRINE SYSTEM | | |__________________________________________________________________________| __________________________________________|__________________________________________________________________________| Page 10 NTP Experiment-Test: 88122-06 NEOPLASMS BY INDIVIDUAL ANIMAL (SYSTEMIC LESIONS ABRIDGED) Report: PEIRPT17 Study Type: CHRONIC ELMIRON Date: 06/12/01 Route: GAVAGE Time: 09:26:59 _____________________________________________________________________________________________________________________ | 1| 3| 4| 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| DAY ON TEST | 9| 3| 7| 1| 2| 3| 8| 9| 2| 5| 7| 7| 7| 7| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 2| | 7| 3| 4| 0| 6| 9| 9| 4| 2| 3| 0| 7| 8| 8| 4| 5| 6| 6| 9| 8| 8| 8| 8| 8| 8| __________________________________________|__________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| FISCHER 344 RATS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 28 MG/KG | 9| 6| 9| 8| 8| 6| 6| 9| 6| 8| 5| 9| 8| 9| 5| 6| 6| 8| 9| 5| 5| 6| 7| 7| 8| | 2| 9| 0| 7| 9| 6| 8| 5| 1| 4| 8| 8| 3| 9| 4| 5| 0| 8| 3| 5| 7| 4| 3| 6| 5| __________________________________________|__________________________________________________________________________| ENDOCRINE SYSTEM - cont | | | | Adrenal Cortex | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Adrenal Medulla | + + + + + + + + + + + + + + + + + + + + + + + + +| Pheochromocytoma Benign | X | |__________________________________________________________________________| Islets, Pancreatic | + + + + + + + + + + + + + + + + + + + + + + + + +| Adenoma | | |__________________________________________________________________________| Parathyroid Gland | + + + + M + + + + + M + + + + + + + + + + + + + +| |__________________________________________________________________________| Pituitary Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| Pars Distalis, Adenoma | X X X X X X X X X | |__________________________________________________________________________| Thyroid Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| C-Cell, Adenoma | X X X| C-Cell, Adenoma, Multiple | | _____________________________________________________________________________________________________________________| GENERAL BODY SYSTEM | | None | | _____________________________________________________________________________________________________________________| GENITAL SYSTEM | | |__________________________________________________________________________| Clitoral Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Ovary | + + + + + + + + + + + + + + + + + + + + + + + + +| Granulosa Cell Tumor Malignant | | |__________________________________________________________________________| Oviduct | + | |__________________________________________________________________________| Uterus | + + + + + + + + + + + + + + + + + + + + + + + + +| Polyp Stromal | X X X | _____________________________________________________________________________________________________________________| HEMATOPOIETIC SYSTEM | | |__________________________________________________________________________| Bone Marrow | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| __________________________________________|__________________________________________________________________________| Page 11 NTP Experiment-Test: 88122-06 NEOPLASMS BY INDIVIDUAL ANIMAL (SYSTEMIC LESIONS ABRIDGED) Report: PEIRPT17 Study Type: CHRONIC ELMIRON Date: 06/12/01 Route: GAVAGE Time: 09:26:59 _____________________________________________________________________________________________________________________ | 1| 3| 4| 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| DAY ON TEST | 9| 3| 7| 1| 2| 3| 8| 9| 2| 5| 7| 7| 7| 7| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 2| | 7| 3| 4| 0| 6| 9| 9| 4| 2| 3| 0| 7| 8| 8| 4| 5| 6| 6| 9| 8| 8| 8| 8| 8| 8| __________________________________________|__________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| FISCHER 344 RATS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 28 MG/KG | 9| 6| 9| 8| 8| 6| 6| 9| 6| 8| 5| 9| 8| 9| 5| 6| 6| 8| 9| 5| 5| 6| 7| 7| 8| | 2| 9| 0| 7| 9| 6| 8| 5| 1| 4| 8| 8| 3| 9| 4| 5| 0| 8| 3| 5| 7| 4| 3| 6| 5| __________________________________________|__________________________________________________________________________| HEMATOPOIETIC SYSTEM - cont | | | | Lymph Node | + + + + + + + + + | |__________________________________________________________________________| Lymph Node, Mandibular | M M M M + M + M + M M M M M M M + M M M M M M M M| |__________________________________________________________________________| Lymph Node, Mesenteric | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Spleen | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Thymus | + + + + + + + + + + M + M + + M + + + + + + M + +| _____________________________________________________________________________________________________________________| INTEGUMENTARY SYSTEM | | |__________________________________________________________________________| Mammary Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| Carcinoma | X | Fibroadenoma | X X X X X X X X | Fibroadenoma, Multiple | X | |__________________________________________________________________________| Skin | + + + + + + + + + + + + + + + + + + + + + + + + +| Subcutaneous Tissue, Lipoma | | _____________________________________________________________________________________________________________________| MUSCULOSKELETAL SYSTEM | | |__________________________________________________________________________| Bone | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| NERVOUS SYSTEM | | |__________________________________________________________________________| Brain | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| RESPIRATORY SYSTEM | | |__________________________________________________________________________| Lung | + + + + + + + + + + + + + + + + + + + + + + + + +| Alveolar/Bronchiolar Carcinoma | X | |__________________________________________________________________________| Nose | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Trachea | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________|__________________________________________________________________________| Page 12 NTP Experiment-Test: 88122-06 NEOPLASMS BY INDIVIDUAL ANIMAL (SYSTEMIC LESIONS ABRIDGED) Report: PEIRPT17 Study Type: CHRONIC ELMIRON Date: 06/12/01 Route: GAVAGE Time: 09:26:59 _____________________________________________________________________________________________________________________ | 1| 3| 4| 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| DAY ON TEST | 9| 3| 7| 1| 2| 3| 8| 9| 2| 5| 7| 7| 7| 7| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 2| | 7| 3| 4| 0| 6| 9| 9| 4| 2| 3| 0| 7| 8| 8| 4| 5| 6| 6| 9| 8| 8| 8| 8| 8| 8| __________________________________________|__________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| FISCHER 344 RATS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 28 MG/KG | 9| 6| 9| 8| 8| 6| 6| 9| 6| 8| 5| 9| 8| 9| 5| 6| 6| 8| 9| 5| 5| 6| 7| 7| 8| | 2| 9| 0| 7| 9| 6| 8| 5| 1| 4| 8| 8| 3| 9| 4| 5| 0| 8| 3| 5| 7| 4| 3| 6| 5| __________________________________________|__________________________________________________________________________| SPECIAL SENSES SYSTEM | | |__________________________________________________________________________| Eye | + + + | _____________________________________________________________________________________________________________________| URINARY SYSTEM | | |__________________________________________________________________________| Kidney | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Urinary Bladder | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________|__________________________________________________________________________| SYSTEMIC LESIONS | | __________________________________________________________________________| Multiple Organs | + + + + + + + + + + + + + + + + + + + + + + + + +| Leukemia Mononuclear | X X X X X X X X | __________________________________________|__________________________________________________________________________| Page 13 NTP Experiment-Test: 88122-06 NEOPLASMS BY INDIVIDUAL ANIMAL (SYSTEMIC LESIONS ABRIDGED) Report: PEIRPT17 Study Type: CHRONIC ELMIRON Date: 06/12/01 Route: GAVAGE Time: 09:26:59 __________________________________________________________________________________________________________________________________ | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| | DAY ON TEST | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| | | 8| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | __________________________________________|__________________________________________________________________________| T (*) | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| O | FISCHER 344 RATS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| T | ANIMAL ID | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 3| A | 28 MG/KG | 9| 5| 5| 5| 5| 6| 6| 6| 7| 7| 8| 8| 8| 9| 9| 5| 7| 7| 7| 7| 7| 7| 8| 9| 0| L | | 4| 2| 3| 6| 9| 2| 3| 7| 4| 8| 1| 2| 6| 1| 6| 1| 0| 1| 2| 5| 7| 9| 0| 7| 0| | _____________________________________________________________________________________________________________________|____________| ALIMENTARY SYSTEM | | | |__________________________________________________________________________|____________| Esophagus | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Intestine Large, Colon | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Intestine Large, Rectum | + + + + + + + + + + + + + + + + + + + + + + + + +| 43 | |__________________________________________________________________________|____________| Intestine Large, Cecum | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Intestine Small, Duodenum | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Intestine Small, Jejunum | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Intestine Small, Ileum | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Liver | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Mesentery | + | 4 | |__________________________________________________________________________|____________| Oral Mucosa | + | 1 | |__________________________________________________________________________|____________| Pancreas | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Salivary Glands | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Stomach, Forestomach | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Stomach, Glandular | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | _____________________________________________________________________________________________________________________| | CARDIOVASCULAR SYSTEM | | | |__________________________________________________________________________|____________| Blood Vessel | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| _____________________________________________________________________________________________________________________|____________| * : Total animals with tissue examined microscopically; total animals with tumor + : Tissue examined microscopically M : Missing tissue X : Lesion present A : Autolysis precludes evaluation I : Insufficient tissue BLANK : Not examined microscopically Page 14 NTP Experiment-Test: 88122-06 NEOPLASMS BY INDIVIDUAL ANIMAL (SYSTEMIC LESIONS ABRIDGED) Report: PEIRPT17 Study Type: CHRONIC ELMIRON Date: 06/12/01 Route: GAVAGE Time: 09:26:59 __________________________________________________________________________________________________________________________________ | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| | DAY ON TEST | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| | | 8| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | __________________________________________|__________________________________________________________________________| T (*) | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| O | FISCHER 344 RATS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| T | ANIMAL ID | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 3| A | 28 MG/KG | 9| 5| 5| 5| 5| 6| 6| 6| 7| 7| 8| 8| 8| 9| 9| 5| 7| 7| 7| 7| 7| 7| 8| 9| 0| L | | 4| 2| 3| 6| 9| 2| 3| 7| 4| 8| 1| 2| 6| 1| 6| 1| 0| 1| 2| 5| 7| 9| 0| 7| 0| | _____________________________________________________________________________________________________________________|____________| CARDIOVASCULAR SYSTEM - cont | | | | | | Heart | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | _____________________________________________________________________________________________________________________| | ENDOCRINE SYSTEM | | | |__________________________________________________________________________|____________| Adrenal Cortex | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Adrenal Medulla | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Pheochromocytoma Benign | | 1 | |__________________________________________________________________________|____________| Islets, Pancreatic | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Adenoma | X | 1 | |__________________________________________________________________________|____________| Parathyroid Gland | + + + + + + + M + M + + + + + M M + + + + + + + +| 44 | |__________________________________________________________________________|____________| Pituitary Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Pars Distalis, Adenoma | X X X X X X X X X X X X | 21 | |__________________________________________________________________________|____________| Thyroid Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | C-Cell, Adenoma | X X X X | 7 | C-Cell, Adenoma, Multiple | X | 1 | _____________________________________________________________________________________________________________________| | GENERAL BODY SYSTEM | | | None | | | _____________________________________________________________________________________________________________________| | GENITAL SYSTEM | | | |__________________________________________________________________________|____________| Clitoral Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Ovary | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Granulosa Cell Tumor Malignant | X | 1 | |__________________________________________________________________________|____________| Oviduct | | 1 | _____________________________________________________________________________________________________________________|____________| * : Total animals with tissue examined microscopically; total animals with tumor + : Tissue examined microscopically M : Missing tissue X : Lesion present A : Autolysis precludes evaluation I : Insufficient tissue BLANK : Not examined microscopically Page 15 NTP Experiment-Test: 88122-06 NEOPLASMS BY INDIVIDUAL ANIMAL (SYSTEMIC LESIONS ABRIDGED) Report: PEIRPT17 Study Type: CHRONIC ELMIRON Date: 06/12/01 Route: GAVAGE Time: 09:26:59 __________________________________________________________________________________________________________________________________ | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| | DAY ON TEST | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| | | 8| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | __________________________________________|__________________________________________________________________________| T (*) | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| O | FISCHER 344 RATS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| T | ANIMAL ID | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 3| A | 28 MG/KG | 9| 5| 5| 5| 5| 6| 6| 6| 7| 7| 8| 8| 8| 9| 9| 5| 7| 7| 7| 7| 7| 7| 8| 9| 0| L | | 4| 2| 3| 6| 9| 2| 3| 7| 4| 8| 1| 2| 6| 1| 6| 1| 0| 1| 2| 5| 7| 9| 0| 7| 0| | _____________________________________________________________________________________________________________________|____________| GENITAL SYSTEM - cont | | | | | | |__________________________________________________________________________|____________| Uterus | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Polyp Stromal | X X X X X | 8 | _____________________________________________________________________________________________________________________| | HEMATOPOIETIC SYSTEM | | | |__________________________________________________________________________|____________| Bone Marrow | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Lymph Node | + + + + + + + + + + | 19 | |__________________________________________________________________________|____________| Lymph Node, Mandibular | M M M M M + M M + M M M M M M M + M M + M M M M M| 8 | |__________________________________________________________________________|____________| Lymph Node, Mesenteric | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Spleen | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Thymus | + + M + + + + M + + + + M + + + + M + M + + + + +| 41 | _____________________________________________________________________________________________________________________| | INTEGUMENTARY SYSTEM | | | |__________________________________________________________________________|____________| Mammary Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Carcinoma | | 1 | Fibroadenoma | X X X X X X X X X X X X X| 21 | Fibroadenoma, Multiple | X | 2 | |__________________________________________________________________________|____________| Skin | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Subcutaneous Tissue, Lipoma | X | 1 | _____________________________________________________________________________________________________________________| | MUSCULOSKELETAL SYSTEM | | | |__________________________________________________________________________|____________| Bone | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | _____________________________________________________________________________________________________________________| | * : Total animals with tissue examined microscopically; total animals with tumor + : Tissue examined microscopically M : Missing tissue X : Lesion present A : Autolysis precludes evaluation I : Insufficient tissue BLANK : Not examined microscopically Page 16 NTP Experiment-Test: 88122-06 NEOPLASMS BY INDIVIDUAL ANIMAL (SYSTEMIC LESIONS ABRIDGED) Report: PEIRPT17 Study Type: CHRONIC ELMIRON Date: 06/12/01 Route: GAVAGE Time: 09:26:59 __________________________________________________________________________________________________________________________________ | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| | DAY ON TEST | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| | | 8| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | __________________________________________|__________________________________________________________________________| T (*) | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| O | FISCHER 344 RATS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| T | ANIMAL ID | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 3| A | 28 MG/KG | 9| 5| 5| 5| 5| 6| 6| 6| 7| 7| 8| 8| 8| 9| 9| 5| 7| 7| 7| 7| 7| 7| 8| 9| 0| L | | 4| 2| 3| 6| 9| 2| 3| 7| 4| 8| 1| 2| 6| 1| 6| 1| 0| 1| 2| 5| 7| 9| 0| 7| 0| | _____________________________________________________________________________________________________________________|____________| NERVOUS SYSTEM | | | |__________________________________________________________________________|____________| Brain | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | _____________________________________________________________________________________________________________________| | RESPIRATORY SYSTEM | | | |__________________________________________________________________________|____________| Lung | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Alveolar/Bronchiolar Carcinoma | | 1 | |__________________________________________________________________________|____________| Nose | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Trachea | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | _____________________________________________________________________________________________________________________| | SPECIAL SENSES SYSTEM | | | |__________________________________________________________________________|____________| Eye | | 3 | _____________________________________________________________________________________________________________________| | URINARY SYSTEM | | | |__________________________________________________________________________|____________| Kidney | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Urinary Bladder | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | __________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS | | | __________________________________________________________________________|____________| Multiple Organs | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Leukemia Mononuclear | X X X X X X | 14 | __________________________________________________________________________________________________________________________________ * : Total animals with tissue examined microscopically; total animals with tumor + : Tissue examined microscopically M : Missing tissue X : Lesion present A : Autolysis precludes evaluation I : Insufficient tissue BLANK : Not examined microscopically Page 17 NTP Experiment-Test: 88122-06 NEOPLASMS BY INDIVIDUAL ANIMAL (SYSTEMIC LESIONS ABRIDGED) Report: PEIRPT17 Study Type: CHRONIC ELMIRON Date: 06/12/01 Route: GAVAGE Time: 09:26:59 _____________________________________________________________________________________________________________________ | 1| 3| 4| 4| 4| 4| 5| 5| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 7| 7| DAY ON TEST | 1| 7| 0| 7| 8| 9| 4| 5| 1| 4| 5| 6| 6| 6| 7| 7| 8| 9| 1| 1| 1| 2| 2| 2| 2| | 1| 5| 5| 4| 3| 1| 5| 9| 4| 5| 3| 4| 7| 7| 3| 8| 5| 1| 1| 3| 5| 3| 8| 8| 8| __________________________________________|__________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| FISCHER 344 RATS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 84 MG/KG | 2| 0| 3| 0| 1| 0| 2| 2| 2| 3| 2| 3| 0| 4| 1| 2| 0| 1| 3| 3| 3| 1| 0| 0| 1| | 2| 8| 2| 9| 3| 1| 9| 0| 4| 0| 6| 3| 6| 1| 5| 7| 3| 4| 4| 9| 6| 9| 2| 4| 0| __________________________________________|__________________________________________________________________________| ALIMENTARY SYSTEM | | |__________________________________________________________________________| Esophagus | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Intestine Large, Colon | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Intestine Large, Rectum | A A + + + + A + A + + A A + + + + + + + + + + + +| Leiomyosarcoma, Metastatic, Vagina | X | |__________________________________________________________________________| Intestine Large, Cecum | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Intestine Small, Duodenum | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Intestine Small, Jejunum | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Intestine Small, Ileum | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Liver | + + + + + + + + + + + + + + + + + + + + + + + + +| Fibrous Histiocytoma | X | |__________________________________________________________________________| Mesentery | + + + + + | |__________________________________________________________________________| Oral Mucosa | | |__________________________________________________________________________| Pancreas | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Salivary Glands | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Stomach, Forestomach | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Stomach, Glandular | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| CARDIOVASCULAR SYSTEM | | |__________________________________________________________________________| Blood Vessel | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Heart | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| __________________________________________|__________________________________________________________________________| Page 18 NTP Experiment-Test: 88122-06 NEOPLASMS BY INDIVIDUAL ANIMAL (SYSTEMIC LESIONS ABRIDGED) Report: PEIRPT17 Study Type: CHRONIC ELMIRON Date: 06/12/01 Route: GAVAGE Time: 09:26:59 _____________________________________________________________________________________________________________________ | 1| 3| 4| 4| 4| 4| 5| 5| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 7| 7| DAY ON TEST | 1| 7| 0| 7| 8| 9| 4| 5| 1| 4| 5| 6| 6| 6| 7| 7| 8| 9| 1| 1| 1| 2| 2| 2| 2| | 1| 5| 5| 4| 3| 1| 5| 9| 4| 5| 3| 4| 7| 7| 3| 8| 5| 1| 1| 3| 5| 3| 8| 8| 8| __________________________________________|__________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| FISCHER 344 RATS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 84 MG/KG | 2| 0| 3| 0| 1| 0| 2| 2| 2| 3| 2| 3| 0| 4| 1| 2| 0| 1| 3| 3| 3| 1| 0| 0| 1| | 2| 8| 2| 9| 3| 1| 9| 0| 4| 0| 6| 3| 6| 1| 5| 7| 3| 4| 4| 9| 6| 9| 2| 4| 0| __________________________________________|__________________________________________________________________________| ENDOCRINE SYSTEM | | |__________________________________________________________________________| Adrenal Cortex | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Adrenal Medulla | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Islets, Pancreatic | + + + + + + + + + + + + + + + + + + + + + + + + +| Adenoma | | |__________________________________________________________________________| Parathyroid Gland | + + + + + + + M + + + + M + + M + + + M + + + + +| |__________________________________________________________________________| Pituitary Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| Pars Distalis, Adenoma | X X X X X X X X X X X X X X X| Pars Intermedia, Adenoma | | |__________________________________________________________________________| Thyroid Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| Bilateral, C-Cell, Adenoma | | C-Cell, Adenoma | X X X X X | _____________________________________________________________________________________________________________________| GENERAL BODY SYSTEM | | None | | _____________________________________________________________________________________________________________________| GENITAL SYSTEM | | |__________________________________________________________________________| Clitoral Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Ovary | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Uterus | + + + + + + + + + + + + + + + + + + + + + + + + +| Adenocarcinoma | | Polyp Stromal | X X X X | Sarcoma Stromal | X | |__________________________________________________________________________| Vagina | + + | Leiomyosarcoma | X | _____________________________________________________________________________________________________________________| HEMATOPOIETIC SYSTEM | | |__________________________________________________________________________| __________________________________________|__________________________________________________________________________| Page 19 NTP Experiment-Test: 88122-06 NEOPLASMS BY INDIVIDUAL ANIMAL (SYSTEMIC LESIONS ABRIDGED) Report: PEIRPT17 Study Type: CHRONIC ELMIRON Date: 06/12/01 Route: GAVAGE Time: 09:26:59 _____________________________________________________________________________________________________________________ | 1| 3| 4| 4| 4| 4| 5| 5| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 7| 7| DAY ON TEST | 1| 7| 0| 7| 8| 9| 4| 5| 1| 4| 5| 6| 6| 6| 7| 7| 8| 9| 1| 1| 1| 2| 2| 2| 2| | 1| 5| 5| 4| 3| 1| 5| 9| 4| 5| 3| 4| 7| 7| 3| 8| 5| 1| 1| 3| 5| 3| 8| 8| 8| __________________________________________|__________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| FISCHER 344 RATS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 84 MG/KG | 2| 0| 3| 0| 1| 0| 2| 2| 2| 3| 2| 3| 0| 4| 1| 2| 0| 1| 3| 3| 3| 1| 0| 0| 1| | 2| 8| 2| 9| 3| 1| 9| 0| 4| 0| 6| 3| 6| 1| 5| 7| 3| 4| 4| 9| 6| 9| 2| 4| 0| __________________________________________|__________________________________________________________________________| HEMATOPOIETIC SYSTEM - cont | | | | Bone Marrow | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Lymph Node | + + + + + + + | |__________________________________________________________________________| Lymph Node, Mandibular | M M M M M M M M M M M M M M M M M M M M M M M M M| |__________________________________________________________________________| Lymph Node, Mesenteric | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Spleen | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Thymus | + + + + + + + + + + M + M + + + + + M + M + + + +| _____________________________________________________________________________________________________________________| INTEGUMENTARY SYSTEM | | |__________________________________________________________________________| Mammary Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| Adenoma | | Carcinoma | | Fibroadenoma | X X X X X | Fibroadenoma, Multiple | X X X | |__________________________________________________________________________| Skin | + + + + + + + + + + + + + + + + + + + + + + + + +| Keratoacanthoma | | Subcutaneous Tissue, Fibroma | X | Subcutaneous Tissue, Fibrous | | Histiocytoma | X | _____________________________________________________________________________________________________________________| MUSCULOSKELETAL SYSTEM | | |__________________________________________________________________________| Bone | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Skeletal Muscle | + | Leiomyosarcoma, Metastatic, Vagina | X | _____________________________________________________________________________________________________________________| NERVOUS SYSTEM | | |__________________________________________________________________________| Brain | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________|__________________________________________________________________________| Page 20 NTP Experiment-Test: 88122-06 NEOPLASMS BY INDIVIDUAL ANIMAL (SYSTEMIC LESIONS ABRIDGED) Report: PEIRPT17 Study Type: CHRONIC ELMIRON Date: 06/12/01 Route: GAVAGE Time: 09:26:59 _____________________________________________________________________________________________________________________ | 1| 3| 4| 4| 4| 4| 5| 5| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 7| 7| DAY ON TEST | 1| 7| 0| 7| 8| 9| 4| 5| 1| 4| 5| 6| 6| 6| 7| 7| 8| 9| 1| 1| 1| 2| 2| 2| 2| | 1| 5| 5| 4| 3| 1| 5| 9| 4| 5| 3| 4| 7| 7| 3| 8| 5| 1| 1| 3| 5| 3| 8| 8| 8| __________________________________________|__________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| FISCHER 344 RATS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 84 MG/KG | 2| 0| 3| 0| 1| 0| 2| 2| 2| 3| 2| 3| 0| 4| 1| 2| 0| 1| 3| 3| 3| 1| 0| 0| 1| | 2| 8| 2| 9| 3| 1| 9| 0| 4| 0| 6| 3| 6| 1| 5| 7| 3| 4| 4| 9| 6| 9| 2| 4| 0| __________________________________________|__________________________________________________________________________| NERVOUS SYSTEM - cont | | | | Astrocytoma Malignant | X | |__________________________________________________________________________| Peripheral Nerve | + | |__________________________________________________________________________| Spinal Cord | + | _____________________________________________________________________________________________________________________| RESPIRATORY SYSTEM | | |__________________________________________________________________________| Lung | + + + + + + + + + + + + + + + + + + + + + + + + +| Fibrous Histiocytoma | X | |__________________________________________________________________________| Nose | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Trachea | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| SPECIAL SENSES SYSTEM | | |__________________________________________________________________________| Eye | + | _____________________________________________________________________________________________________________________| URINARY SYSTEM | | |__________________________________________________________________________| Kidney | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Urinary Bladder | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________|__________________________________________________________________________| SYSTEMIC LESIONS | | __________________________________________________________________________| Multiple Organs | + + + + + + + + + + + + + + + + + + + + + + + + +| Leukemia Mononuclear | X X X X X X | __________________________________________|__________________________________________________________________________| Page 21 NTP Experiment-Test: 88122-06 NEOPLASMS BY INDIVIDUAL ANIMAL (SYSTEMIC LESIONS ABRIDGED) Report: PEIRPT17 Study Type: CHRONIC ELMIRON Date: 06/12/01 Route: GAVAGE Time: 09:26:59 __________________________________________________________________________________________________________________________________ | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| | DAY ON TEST | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| | | 8| 8| 8| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 9| 9| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | __________________________________________|__________________________________________________________________________| T (*) | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| O | FISCHER 344 RATS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| T | ANIMAL ID | 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| A | 84 MG/KG | 1| 1| 1| 1| 2| 2| 3| 3| 3| 4| 4| 4| 4| 4| 4| 0| 0| 1| 2| 2| 3| 4| 4| 4| 5| L | | 2| 6| 7| 8| 5| 8| 7| 8| 1| 3| 4| 5| 7| 8| 9| 5| 7| 1| 1| 3| 5| 0| 2| 6| 0| | _____________________________________________________________________________________________________________________|____________| ALIMENTARY SYSTEM | | | |__________________________________________________________________________|____________| Esophagus | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Intestine Large, Colon | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Intestine Large, Rectum | + + + + + + + + + + + + + + + + + + + + + + + + +| 44 | Leiomyosarcoma, Metastatic, Vagina | | 1 | |__________________________________________________________________________|____________| Intestine Large, Cecum | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Intestine Small, Duodenum | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Intestine Small, Jejunum | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Intestine Small, Ileum | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Liver | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Fibrous Histiocytoma | | 1 | |__________________________________________________________________________|____________| Mesentery | + | 6 | |__________________________________________________________________________|____________| Oral Mucosa | + | 1 | |__________________________________________________________________________|____________| Pancreas | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Salivary Glands | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Stomach, Forestomach | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Stomach, Glandular | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | _____________________________________________________________________________________________________________________| | CARDIOVASCULAR SYSTEM | | | |__________________________________________________________________________|____________| _____________________________________________________________________________________________________________________|____________| * : Total animals with tissue examined microscopically; total animals with tumor + : Tissue examined microscopically M : Missing tissue X : Lesion present A : Autolysis precludes evaluation I : Insufficient tissue BLANK : Not examined microscopically Page 22 NTP Experiment-Test: 88122-06 NEOPLASMS BY INDIVIDUAL ANIMAL (SYSTEMIC LESIONS ABRIDGED) Report: PEIRPT17 Study Type: CHRONIC ELMIRON Date: 06/12/01 Route: GAVAGE Time: 09:26:59 __________________________________________________________________________________________________________________________________ | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| | DAY ON TEST | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| | | 8| 8| 8| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 9| 9| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | __________________________________________|__________________________________________________________________________| T (*) | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| O | FISCHER 344 RATS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| T | ANIMAL ID | 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| A | 84 MG/KG | 1| 1| 1| 1| 2| 2| 3| 3| 3| 4| 4| 4| 4| 4| 4| 0| 0| 1| 2| 2| 3| 4| 4| 4| 5| L | | 2| 6| 7| 8| 5| 8| 7| 8| 1| 3| 4| 5| 7| 8| 9| 5| 7| 1| 1| 3| 5| 0| 2| 6| 0| | _____________________________________________________________________________________________________________________|____________| CARDIOVASCULAR SYSTEM - cont | | | | | | Blood Vessel | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Heart | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | _____________________________________________________________________________________________________________________| | ENDOCRINE SYSTEM | | | |__________________________________________________________________________|____________| Adrenal Cortex | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Adrenal Medulla | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Islets, Pancreatic | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Adenoma | X X | 2 | |__________________________________________________________________________|____________| Parathyroid Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| 46 | |__________________________________________________________________________|____________| Pituitary Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Pars Distalis, Adenoma | X X X X X X X X X X X | 26 | Pars Intermedia, Adenoma | X | 1 | |__________________________________________________________________________|____________| Thyroid Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Bilateral, C-Cell, Adenoma | X | 1 | C-Cell, Adenoma | X X X X | 9 | _____________________________________________________________________________________________________________________| | GENERAL BODY SYSTEM | | | None | | | _____________________________________________________________________________________________________________________| | GENITAL SYSTEM | | | |__________________________________________________________________________|____________| Clitoral Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Ovary | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| _____________________________________________________________________________________________________________________|____________| * : Total animals with tissue examined microscopically; total animals with tumor + : Tissue examined microscopically M : Missing tissue X : Lesion present A : Autolysis precludes evaluation I : Insufficient tissue BLANK : Not examined microscopically Page 23 NTP Experiment-Test: 88122-06 NEOPLASMS BY INDIVIDUAL ANIMAL (SYSTEMIC LESIONS ABRIDGED) Report: PEIRPT17 Study Type: CHRONIC ELMIRON Date: 06/12/01 Route: GAVAGE Time: 09:26:59 __________________________________________________________________________________________________________________________________ | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| | DAY ON TEST | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| | | 8| 8| 8| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 9| 9| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | __________________________________________|__________________________________________________________________________| T (*) | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| O | FISCHER 344 RATS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| T | ANIMAL ID | 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| A | 84 MG/KG | 1| 1| 1| 1| 2| 2| 3| 3| 3| 4| 4| 4| 4| 4| 4| 0| 0| 1| 2| 2| 3| 4| 4| 4| 5| L | | 2| 6| 7| 8| 5| 8| 7| 8| 1| 3| 4| 5| 7| 8| 9| 5| 7| 1| 1| 3| 5| 0| 2| 6| 0| | _____________________________________________________________________________________________________________________|____________| GENITAL SYSTEM - cont | | | | | | Uterus | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Adenocarcinoma | X | 1 | Polyp Stromal | X X X | 7 | Sarcoma Stromal | | 1 | |__________________________________________________________________________|____________| Vagina | | 2 | Leiomyosarcoma | | 1 | _____________________________________________________________________________________________________________________| | HEMATOPOIETIC SYSTEM | | | |__________________________________________________________________________|____________| Bone Marrow | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Lymph Node | + + + + + + + | 14 | |__________________________________________________________________________|____________| Lymph Node, Mandibular | + M M M M M M + + M M M M M M M M M M M M M M M M| 3 | |__________________________________________________________________________|____________| Lymph Node, Mesenteric | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Spleen | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Thymus | + + + + + + + + + + + + + + + + + + + + + + + + +| 46 | _____________________________________________________________________________________________________________________| | INTEGUMENTARY SYSTEM | | | |__________________________________________________________________________|____________| Mammary Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Adenoma | X | 1 | Carcinoma | X | 1 | Fibroadenoma | X X X X X X X X X X X| 16 | Fibroadenoma, Multiple | X X X X X | 8 | |__________________________________________________________________________|____________| Skin | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Keratoacanthoma | X | 1 | _____________________________________________________________________________________________________________________|____________| * : Total animals with tissue examined microscopically; total animals with tumor + : Tissue examined microscopically M : Missing tissue X : Lesion present A : Autolysis precludes evaluation I : Insufficient tissue BLANK : Not examined microscopically Page 24 NTP Experiment-Test: 88122-06 NEOPLASMS BY INDIVIDUAL ANIMAL (SYSTEMIC LESIONS ABRIDGED) Report: PEIRPT17 Study Type: CHRONIC ELMIRON Date: 06/12/01 Route: GAVAGE Time: 09:26:59 __________________________________________________________________________________________________________________________________ | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| | DAY ON TEST | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| | | 8| 8| 8| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 9| 9| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | __________________________________________|__________________________________________________________________________| T (*) | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| O | FISCHER 344 RATS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| T | ANIMAL ID | 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| A | 84 MG/KG | 1| 1| 1| 1| 2| 2| 3| 3| 3| 4| 4| 4| 4| 4| 4| 0| 0| 1| 2| 2| 3| 4| 4| 4| 5| L | | 2| 6| 7| 8| 5| 8| 7| 8| 1| 3| 4| 5| 7| 8| 9| 5| 7| 1| 1| 3| 5| 0| 2| 6| 0| | _____________________________________________________________________________________________________________________|____________| INTEGUMENTARY SYSTEM - cont | | | | | | Subcutaneous Tissue, Fibroma | X | 2 | Subcutaneous Tissue, Fibrous | | | Histiocytoma | | 1 | _____________________________________________________________________________________________________________________| | MUSCULOSKELETAL SYSTEM | | | |__________________________________________________________________________|____________| Bone | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Skeletal Muscle | | 1 | Leiomyosarcoma, Metastatic, Vagina | | 1 | _____________________________________________________________________________________________________________________| | NERVOUS SYSTEM | | | |__________________________________________________________________________|____________| Brain | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Astrocytoma Malignant | | 1 | |__________________________________________________________________________|____________| Peripheral Nerve | | 1 | |__________________________________________________________________________|____________| Spinal Cord | | 1 | _____________________________________________________________________________________________________________________| | RESPIRATORY SYSTEM | | | |__________________________________________________________________________|____________| Lung | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Fibrous Histiocytoma | | 1 | |__________________________________________________________________________|____________| Nose | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Trachea | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | _____________________________________________________________________________________________________________________| | SPECIAL SENSES SYSTEM | | | |__________________________________________________________________________|____________| Eye | | 1 | _____________________________________________________________________________________________________________________|____________| * : Total animals with tissue examined microscopically; total animals with tumor + : Tissue examined microscopically M : Missing tissue X : Lesion present A : Autolysis precludes evaluation I : Insufficient tissue BLANK : Not examined microscopically Page 25 NTP Experiment-Test: 88122-06 NEOPLASMS BY INDIVIDUAL ANIMAL (SYSTEMIC LESIONS ABRIDGED) Report: PEIRPT17 Study Type: CHRONIC ELMIRON Date: 06/12/01 Route: GAVAGE Time: 09:26:59 __________________________________________________________________________________________________________________________________ | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| | DAY ON TEST | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| | | 8| 8| 8| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 9| 9| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | __________________________________________|__________________________________________________________________________| T (*) | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| O | FISCHER 344 RATS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| T | ANIMAL ID | 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| A | 84 MG/KG | 1| 1| 1| 1| 2| 2| 3| 3| 3| 4| 4| 4| 4| 4| 4| 0| 0| 1| 2| 2| 3| 4| 4| 4| 5| L | | 2| 6| 7| 8| 5| 8| 7| 8| 1| 3| 4| 5| 7| 8| 9| 5| 7| 1| 1| 3| 5| 0| 2| 6| 0| | _____________________________________________________________________________________________________________________|____________| URINARY SYSTEM | | | |__________________________________________________________________________|____________| Kidney | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Urinary Bladder | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | __________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS | | | __________________________________________________________________________|____________| Multiple Organs | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Leukemia Mononuclear | X X| 8 | __________________________________________________________________________________________________________________________________ * : Total animals with tissue examined microscopically; total animals with tumor + : Tissue examined microscopically M : Missing tissue X : Lesion present A : Autolysis precludes evaluation I : Insufficient tissue BLANK : Not examined microscopically Page 26 NTP Experiment-Test: 88122-06 NEOPLASMS BY INDIVIDUAL ANIMAL (SYSTEMIC LESIONS ABRIDGED) Report: PEIRPT17 Study Type: CHRONIC ELMIRON Date: 06/12/01 Route: GAVAGE Time: 09:26:59 _____________________________________________________________________________________________________________________ | 1| 1| 2| 2| 3| 3| 4| 5| 5| 5| 6| 6| 6| 6| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 7| DAY ON TEST | 1| 3| 1| 7| 2| 7| 9| 1| 2| 8| 0| 2| 5| 5| 6| 6| 7| 7| 8| 0| 2| 2| 2| 2| 2| | 1| 9| 6| 3| 9| 9| 5| 8| 5| 8| 3| 4| 1| 6| 0| 7| 2| 8| 0| 6| 0| 3| 7| 8| 8| __________________________________________|__________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| FISCHER 344 RATS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 4| 3| 3| 3| 3| 3| 3| 3| 3| 3| 252 | 5| 8| 5| 8| 6| 9| 7| 9| 7| 8| 7| 6| 5| 9| 8| 0| 5| 8| 8| 6| 9| 9| 6| 5| 5| MG/KG | 4| 9| 5| 5| 8| 0| 9| 9| 1| 3| 3| 5| 6| 5| 8| 0| 7| 4| 6| 4| 7| 8| 0| 3| 8| __________________________________________|__________________________________________________________________________| ALIMENTARY SYSTEM | | |__________________________________________________________________________| Esophagus | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Intestine Large, Colon | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Intestine Large, Rectum | A A A + + A A + + + + A + A + + A + + + + + + + +| |__________________________________________________________________________| Intestine Large, Cecum | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Intestine Small, Duodenum | + + + + + + M + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Intestine Small, Jejunum | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Intestine Small, Ileum | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Liver | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Mesentery | + + + + + + | |__________________________________________________________________________| Pancreas | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Salivary Glands | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Stomach, Forestomach | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Stomach, Glandular | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| CARDIOVASCULAR SYSTEM | | |__________________________________________________________________________| Blood Vessel | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Heart | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| ENDOCRINE SYSTEM | | |__________________________________________________________________________| Adrenal Cortex | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| __________________________________________|__________________________________________________________________________| Page 27 NTP Experiment-Test: 88122-06 NEOPLASMS BY INDIVIDUAL ANIMAL (SYSTEMIC LESIONS ABRIDGED) Report: PEIRPT17 Study Type: CHRONIC ELMIRON Date: 06/12/01 Route: GAVAGE Time: 09:26:59 _____________________________________________________________________________________________________________________ | 1| 1| 2| 2| 3| 3| 4| 5| 5| 5| 6| 6| 6| 6| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 7| DAY ON TEST | 1| 3| 1| 7| 2| 7| 9| 1| 2| 8| 0| 2| 5| 5| 6| 6| 7| 7| 8| 0| 2| 2| 2| 2| 2| | 1| 9| 6| 3| 9| 9| 5| 8| 5| 8| 3| 4| 1| 6| 0| 7| 2| 8| 0| 6| 0| 3| 7| 8| 8| __________________________________________|__________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| FISCHER 344 RATS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 4| 3| 3| 3| 3| 3| 3| 3| 3| 3| 252 | 5| 8| 5| 8| 6| 9| 7| 9| 7| 8| 7| 6| 5| 9| 8| 0| 5| 8| 8| 6| 9| 9| 6| 5| 5| MG/KG | 4| 9| 5| 5| 8| 0| 9| 9| 1| 3| 3| 5| 6| 5| 8| 0| 7| 4| 6| 4| 7| 8| 0| 3| 8| __________________________________________|__________________________________________________________________________| ENDOCRINE SYSTEM - cont | | | | Adrenal Medulla | + + + + + + + + + + + + + + + + + + + + + + + + +| Pheochromocytoma Benign | X | |__________________________________________________________________________| Islets, Pancreatic | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Parathyroid Gland | + + + + + M + + + M + + + + + + + + + + + + + M +| |__________________________________________________________________________| Pituitary Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| Pars Distalis, Adenoma | X X X X X X X X X X| |__________________________________________________________________________| Thyroid Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| C-Cell, Adenoma | X X X X X | Follicle, Carcinoma | | _____________________________________________________________________________________________________________________| GENERAL BODY SYSTEM | | None | | _____________________________________________________________________________________________________________________| GENITAL SYSTEM | | |__________________________________________________________________________| Clitoral Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| Adenoma | X | |__________________________________________________________________________| Ovary | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Uterus | + + + + + + + + + + + + + + + + + + + + + + + + +| Leiomyoma | | Polyp Stromal | X | Endometrium, Polyp Stromal | | Endometrium, Sarcoma Stromal | X | |__________________________________________________________________________| Vagina | + + | Leiomyosarcoma | X | _____________________________________________________________________________________________________________________| HEMATOPOIETIC SYSTEM | | |__________________________________________________________________________| Bone Marrow | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________|__________________________________________________________________________| Page 28 NTP Experiment-Test: 88122-06 NEOPLASMS BY INDIVIDUAL ANIMAL (SYSTEMIC LESIONS ABRIDGED) Report: PEIRPT17 Study Type: CHRONIC ELMIRON Date: 06/12/01 Route: GAVAGE Time: 09:26:59 _____________________________________________________________________________________________________________________ | 1| 1| 2| 2| 3| 3| 4| 5| 5| 5| 6| 6| 6| 6| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 7| DAY ON TEST | 1| 3| 1| 7| 2| 7| 9| 1| 2| 8| 0| 2| 5| 5| 6| 6| 7| 7| 8| 0| 2| 2| 2| 2| 2| | 1| 9| 6| 3| 9| 9| 5| 8| 5| 8| 3| 4| 1| 6| 0| 7| 2| 8| 0| 6| 0| 3| 7| 8| 8| __________________________________________|__________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| FISCHER 344 RATS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 4| 3| 3| 3| 3| 3| 3| 3| 3| 3| 252 | 5| 8| 5| 8| 6| 9| 7| 9| 7| 8| 7| 6| 5| 9| 8| 0| 5| 8| 8| 6| 9| 9| 6| 5| 5| MG/KG | 4| 9| 5| 5| 8| 0| 9| 9| 1| 3| 3| 5| 6| 5| 8| 0| 7| 4| 6| 4| 7| 8| 0| 3| 8| __________________________________________|__________________________________________________________________________| HEMATOPOIETIC SYSTEM - cont | | | | |__________________________________________________________________________| Lymph Node | + + + + + | |__________________________________________________________________________| Lymph Node, Mandibular | M M M M M M M M M M M + M M M M M M M M M M M M M| |__________________________________________________________________________| Lymph Node, Mesenteric | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Spleen | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Thymus | + + + + + + M M + M + + + M + M + + + + + + M + +| _____________________________________________________________________________________________________________________| INTEGUMENTARY SYSTEM | | |__________________________________________________________________________| Mammary Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| Adenolipoma | X | Adenoma | X| Carcinoma | X | Fibroadenoma | X X X X X X X| Fibroadenoma, Multiple | X | |__________________________________________________________________________| Skin | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| MUSCULOSKELETAL SYSTEM | | |__________________________________________________________________________| Bone | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| NERVOUS SYSTEM | | |__________________________________________________________________________| Brain | + + + + + + + + + + + + + + + + + + + + + + + + +| Oligodendroglioma Malignant | X | |__________________________________________________________________________| Peripheral Nerve | + | |__________________________________________________________________________| Spinal Cord | + | _____________________________________________________________________________________________________________________| RESPIRATORY SYSTEM | | __________________________________________|__________________________________________________________________________| Page 29 NTP Experiment-Test: 88122-06 NEOPLASMS BY INDIVIDUAL ANIMAL (SYSTEMIC LESIONS ABRIDGED) Report: PEIRPT17 Study Type: CHRONIC ELMIRON Date: 06/12/01 Route: GAVAGE Time: 09:26:59 _____________________________________________________________________________________________________________________ | 1| 1| 2| 2| 3| 3| 4| 5| 5| 5| 6| 6| 6| 6| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 7| DAY ON TEST | 1| 3| 1| 7| 2| 7| 9| 1| 2| 8| 0| 2| 5| 5| 6| 6| 7| 7| 8| 0| 2| 2| 2| 2| 2| | 1| 9| 6| 3| 9| 9| 5| 8| 5| 8| 3| 4| 1| 6| 0| 7| 2| 8| 0| 6| 0| 3| 7| 8| 8| __________________________________________|__________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| FISCHER 344 RATS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 4| 3| 3| 3| 3| 3| 3| 3| 3| 3| 252 | 5| 8| 5| 8| 6| 9| 7| 9| 7| 8| 7| 6| 5| 9| 8| 0| 5| 8| 8| 6| 9| 9| 6| 5| 5| MG/KG | 4| 9| 5| 5| 8| 0| 9| 9| 1| 3| 3| 5| 6| 5| 8| 0| 7| 4| 6| 4| 7| 8| 0| 3| 8| __________________________________________|__________________________________________________________________________| RESPIRATORY SYSTEM - cont | | | | |__________________________________________________________________________| Lung | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Nose | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Trachea | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| SPECIAL SENSES SYSTEM | | |__________________________________________________________________________| Eye | +| _____________________________________________________________________________________________________________________| URINARY SYSTEM | | |__________________________________________________________________________| Kidney | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Urinary Bladder | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________|__________________________________________________________________________| SYSTEMIC LESIONS | | __________________________________________________________________________| Multiple Organs | + + + + + + + + + + + + + + + + + + + + + + + + +| Adenolipoma | X | Leukemia Mononuclear | X X X X X X X X X| __________________________________________|__________________________________________________________________________| Page 30 NTP Experiment-Test: 88122-06 NEOPLASMS BY INDIVIDUAL ANIMAL (SYSTEMIC LESIONS ABRIDGED) Report: PEIRPT17 Study Type: CHRONIC ELMIRON Date: 06/12/01 Route: GAVAGE Time: 09:26:59 __________________________________________________________________________________________________________________________________ | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| | DAY ON TEST | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| | | 8| 8| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 9| 9| 9| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | __________________________________________|__________________________________________________________________________| T (*) | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| O | FISCHER 344 RATS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| T | ANIMAL ID | 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| A | 252 | 5| 6| 6| 7| 7| 9| 9| 5| 6| 7| 7| 8| 8| 9| 9| 5| 6| 6| 6| 7| 7| 7| 8| 8| 9| L | MG/KG | 9| 1| 6| 5| 7| 2| 6| 1| 9| 2| 8| 1| 7| 1| 3| 2| 2| 3| 7| 0| 4| 6| 0| 2| 4| | _____________________________________________________________________________________________________________________|____________| ALIMENTARY SYSTEM | | | |__________________________________________________________________________|____________| Esophagus | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Intestine Large, Colon | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Intestine Large, Rectum | + + + + + + + + + + + + + + + + + + + + + + + + +| 42 | |__________________________________________________________________________|____________| Intestine Large, Cecum | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Intestine Small, Duodenum | + + + + + + + + + + + + + + + + + + + + + + + + +| 49 | |__________________________________________________________________________|____________| Intestine Small, Jejunum | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Intestine Small, Ileum | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Liver | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Mesentery | + + + | 9 | |__________________________________________________________________________|____________| Pancreas | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Salivary Glands | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Stomach, Forestomach | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Stomach, Glandular | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | _____________________________________________________________________________________________________________________| | CARDIOVASCULAR SYSTEM | | | |__________________________________________________________________________|____________| Blood Vessel | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Heart | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | _____________________________________________________________________________________________________________________| | _____________________________________________________________________________________________________________________|____________| * : Total animals with tissue examined microscopically; total animals with tumor + : Tissue examined microscopically M : Missing tissue X : Lesion present A : Autolysis precludes evaluation I : Insufficient tissue BLANK : Not examined microscopically Page 31 NTP Experiment-Test: 88122-06 NEOPLASMS BY INDIVIDUAL ANIMAL (SYSTEMIC LESIONS ABRIDGED) Report: PEIRPT17 Study Type: CHRONIC ELMIRON Date: 06/12/01 Route: GAVAGE Time: 09:26:59 __________________________________________________________________________________________________________________________________ | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| | DAY ON TEST | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| | | 8| 8| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 9| 9| 9| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | __________________________________________|__________________________________________________________________________| T (*) | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| O | FISCHER 344 RATS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| T | ANIMAL ID | 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| A | 252 | 5| 6| 6| 7| 7| 9| 9| 5| 6| 7| 7| 8| 8| 9| 9| 5| 6| 6| 6| 7| 7| 7| 8| 8| 9| L | MG/KG | 9| 1| 6| 5| 7| 2| 6| 1| 9| 2| 8| 1| 7| 1| 3| 2| 2| 3| 7| 0| 4| 6| 0| 2| 4| | _____________________________________________________________________________________________________________________|____________| ENDOCRINE SYSTEM | | | |__________________________________________________________________________|____________| Adrenal Cortex | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Adrenal Medulla | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Pheochromocytoma Benign | X X | 3 | |__________________________________________________________________________|____________| Islets, Pancreatic | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Parathyroid Gland | + + + + + M + + + + M + + + + + + + + + + + + + +| 45 | |__________________________________________________________________________|____________| Pituitary Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Pars Distalis, Adenoma | X X X X X X X X X | 19 | |__________________________________________________________________________|____________| Thyroid Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | C-Cell, Adenoma | X X X X | 9 | Follicle, Carcinoma | X | 1 | _____________________________________________________________________________________________________________________| | GENERAL BODY SYSTEM | | | None | | | _____________________________________________________________________________________________________________________| | GENITAL SYSTEM | | | |__________________________________________________________________________|____________| Clitoral Gland | + + + + + + M + + + + + + + + + + + + + + + + + +| 49 | Adenoma | X X X | 4 | |__________________________________________________________________________|____________| Ovary | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Uterus | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Leiomyoma | X | 1 | Polyp Stromal | X X X X | 5 | Endometrium, Polyp Stromal | X | 1 | Endometrium, Sarcoma Stromal | | 1 | |__________________________________________________________________________|____________| _____________________________________________________________________________________________________________________|____________| * : Total animals with tissue examined microscopically; total animals with tumor + : Tissue examined microscopically M : Missing tissue X : Lesion present A : Autolysis precludes evaluation I : Insufficient tissue BLANK : Not examined microscopically Page 32 NTP Experiment-Test: 88122-06 NEOPLASMS BY INDIVIDUAL ANIMAL (SYSTEMIC LESIONS ABRIDGED) Report: PEIRPT17 Study Type: CHRONIC ELMIRON Date: 06/12/01 Route: GAVAGE Time: 09:26:59 __________________________________________________________________________________________________________________________________ | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| | DAY ON TEST | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| | | 8| 8| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 9| 9| 9| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | __________________________________________|__________________________________________________________________________| T (*) | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| O | FISCHER 344 RATS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| T | ANIMAL ID | 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| A | 252 | 5| 6| 6| 7| 7| 9| 9| 5| 6| 7| 7| 8| 8| 9| 9| 5| 6| 6| 6| 7| 7| 7| 8| 8| 9| L | MG/KG | 9| 1| 6| 5| 7| 2| 6| 1| 9| 2| 8| 1| 7| 1| 3| 2| 2| 3| 7| 0| 4| 6| 0| 2| 4| | _____________________________________________________________________________________________________________________|____________| GENITAL SYSTEM - cont | | | | | | Vagina | | 2 | Leiomyosarcoma | | 1 | _____________________________________________________________________________________________________________________| | HEMATOPOIETIC SYSTEM | | | |__________________________________________________________________________|____________| Bone Marrow | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Lymph Node | + + + + + + + + | 13 | |__________________________________________________________________________|____________| Lymph Node, Mandibular | M M M M M M M M M M M + M M M M M M M M M M M M M| 2 | |__________________________________________________________________________|____________| Lymph Node, Mesenteric | + + + + + + + + + + + + + + + + + + + + + + + +| 49 | |__________________________________________________________________________|____________| Spleen | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Thymus | + + M + + + + + + + + + + + + + + + + + M + M + +| 41 | _____________________________________________________________________________________________________________________| | INTEGUMENTARY SYSTEM | | | |__________________________________________________________________________|____________| Mammary Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Adenolipoma | | 1 | Adenoma | | 1 | Carcinoma | X X | 3 | Fibroadenoma | X X X X X X X X X X | 17 | Fibroadenoma, Multiple | X X X | 4 | |__________________________________________________________________________|____________| Skin | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | _____________________________________________________________________________________________________________________| | MUSCULOSKELETAL SYSTEM | | | |__________________________________________________________________________|____________| Bone | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | _____________________________________________________________________________________________________________________| | * : Total animals with tissue examined microscopically; total animals with tumor + : Tissue examined microscopically M : Missing tissue X : Lesion present A : Autolysis precludes evaluation I : Insufficient tissue BLANK : Not examined microscopically Page 33 NTP Experiment-Test: 88122-06 NEOPLASMS BY INDIVIDUAL ANIMAL (SYSTEMIC LESIONS ABRIDGED) Report: PEIRPT17 Study Type: CHRONIC ELMIRON Date: 06/12/01 Route: GAVAGE Time: 09:26:59 __________________________________________________________________________________________________________________________________ | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| | DAY ON TEST | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| | | 8| 8| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 9| 9| 9| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | __________________________________________|__________________________________________________________________________| T (*) | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| O | FISCHER 344 RATS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| T | ANIMAL ID | 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| A | 252 | 5| 6| 6| 7| 7| 9| 9| 5| 6| 7| 7| 8| 8| 9| 9| 5| 6| 6| 6| 7| 7| 7| 8| 8| 9| L | MG/KG | 9| 1| 6| 5| 7| 2| 6| 1| 9| 2| 8| 1| 7| 1| 3| 2| 2| 3| 7| 0| 4| 6| 0| 2| 4| | _____________________________________________________________________________________________________________________|____________| NERVOUS SYSTEM | | | |__________________________________________________________________________|____________| Brain | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Oligodendroglioma Malignant | | 1 | |__________________________________________________________________________|____________| Peripheral Nerve | | 1 | |__________________________________________________________________________|____________| Spinal Cord | | 1 | _____________________________________________________________________________________________________________________| | RESPIRATORY SYSTEM | | | |__________________________________________________________________________|____________| Lung | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Nose | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Trachea | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | _____________________________________________________________________________________________________________________| | SPECIAL SENSES SYSTEM | | | |__________________________________________________________________________|____________| Eye | + + | 3 | _____________________________________________________________________________________________________________________| | URINARY SYSTEM | | | |__________________________________________________________________________|____________| Kidney | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Urinary Bladder | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | __________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS | | | __________________________________________________________________________|____________| Multiple Organs | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Adenolipoma | | 1 | Leukemia Mononuclear | X | 10 | __________________________________________________________________________________________________________________________________ * : Total animals with tissue examined microscopically; total animals with tumor + : Tissue examined microscopically M : Missing tissue X : Lesion present A : Autolysis precludes evaluation I : Insufficient tissue BLANK : Not examined microscopically Page 34 NTP Experiment-Test: 88122-06 NEOPLASMS BY INDIVIDUAL ANIMAL (SYSTEMIC LESIONS ABRIDGED) Report: PEIRPT17 Study Type: CHRONIC ELMIRON Date: 06/12/01 Route: GAVAGE Time: 09:26:59 _____________________________________________________________________________________________________________________ | 1| 4| 5| 5| 5| 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 7| 7| DAY ON TEST | 1| 7| 0| 0| 1| 1| 2| 4| 7| 8| 0| 3| 4| 4| 6| 8| 8| 9| 0| 1| 2| 2| 2| 2| 2| | 1| 5| 3| 5| 9| 9| 6| 7| 3| 9| 0| 0| 0| 0| 1| 5| 6| 9| 7| 7| 1| 4| 4| 4| 7| __________________________________________|__________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0 MG/KG | 3| 3| 3| 0| 1| 5| 1| 0| 4| 0| 2| 1| 1| 4| 1| 1| 3| 2| 2| 4| 1| 1| 2| 3| 0| | 3| 9| 8| 3| 9| 0| 4| 1| 0| 9| 3| 7| 1| 3| 3| 8| 1| 7| 9| 1| 6| 5| 0| 0| 4| __________________________________________|__________________________________________________________________________| ALIMENTARY SYSTEM | | |__________________________________________________________________________| Esophagus | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Intestine Large, Colon | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Intestine Large, Rectum | + + + + + + + + + + + + + + + A + + A + + + + + +| Polyp Adenomatous | | |__________________________________________________________________________| Intestine Large, Cecum | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Intestine Small, Duodenum | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Intestine Small, Jejunum | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Intestine Small, Ileum | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Liver | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Mesentery | + + + + + | |__________________________________________________________________________| Pancreas | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Salivary Glands | + + + + + + + + + + + + + + + + + + + + + + + + +| Schwannoma Malignant | X | |__________________________________________________________________________| Stomach, Forestomach | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Stomach, Glandular | + + + + + + + + + + + + + + + + + + + + + + + + +| Leiomyosarcoma | | _____________________________________________________________________________________________________________________| CARDIOVASCULAR SYSTEM | | |__________________________________________________________________________| Blood Vessel | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Heart | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| ENDOCRINE SYSTEM | | __________________________________________|__________________________________________________________________________| Page 35 NTP Experiment-Test: 88122-06 NEOPLASMS BY INDIVIDUAL ANIMAL (SYSTEMIC LESIONS ABRIDGED) Report: PEIRPT17 Study Type: CHRONIC ELMIRON Date: 06/12/01 Route: GAVAGE Time: 09:26:59 _____________________________________________________________________________________________________________________ | 1| 4| 5| 5| 5| 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 7| 7| DAY ON TEST | 1| 7| 0| 0| 1| 1| 2| 4| 7| 8| 0| 3| 4| 4| 6| 8| 8| 9| 0| 1| 2| 2| 2| 2| 2| | 1| 5| 3| 5| 9| 9| 6| 7| 3| 9| 0| 0| 0| 0| 1| 5| 6| 9| 7| 7| 1| 4| 4| 4| 7| __________________________________________|__________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0 MG/KG | 3| 3| 3| 0| 1| 5| 1| 0| 4| 0| 2| 1| 1| 4| 1| 1| 3| 2| 2| 4| 1| 1| 2| 3| 0| | 3| 9| 8| 3| 9| 0| 4| 1| 0| 9| 3| 7| 1| 3| 3| 8| 1| 7| 9| 1| 6| 5| 0| 0| 4| __________________________________________|__________________________________________________________________________| ENDOCRINE SYSTEM - cont | | | | |__________________________________________________________________________| Adrenal Cortex | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Adrenal Medulla | + + + + + + + + + + + + + + + + + + + + + + + + +| Pheochromocytoma Malignant | | Pheochromocytoma Benign | X X | Bilateral, Pheochromocytoma Benign | X | |__________________________________________________________________________| Islets, Pancreatic | + + + + + + + + + + + + + + + + + + + + + + + + +| Adenoma | | |__________________________________________________________________________| Parathyroid Gland | + + + + + + M + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Pituitary Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| Pars Distalis, Adenoma | X X X X X X X | Pars Distalis, Carcinoma | X | Pars Intermedia, Adenoma | | |__________________________________________________________________________| Thyroid Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| Bilateral, C-Cell, Adenoma | X | Bilateral, C-Cell, Carcinoma | X | C-Cell, Adenoma | X | C-Cell, Adenoma, Multiple | | C-Cell, Carcinoma | X | Follicle, Carcinoma | | _____________________________________________________________________________________________________________________| GENERAL BODY SYSTEM | | |__________________________________________________________________________| Tissue NOS | | _____________________________________________________________________________________________________________________| GENITAL SYSTEM | | |__________________________________________________________________________| Coagulating Gland | + | |__________________________________________________________________________| Epididymis | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| __________________________________________|__________________________________________________________________________| Page 36 NTP Experiment-Test: 88122-06 NEOPLASMS BY INDIVIDUAL ANIMAL (SYSTEMIC LESIONS ABRIDGED) Report: PEIRPT17 Study Type: CHRONIC ELMIRON Date: 06/12/01 Route: GAVAGE Time: 09:26:59 _____________________________________________________________________________________________________________________ | 1| 4| 5| 5| 5| 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 7| 7| DAY ON TEST | 1| 7| 0| 0| 1| 1| 2| 4| 7| 8| 0| 3| 4| 4| 6| 8| 8| 9| 0| 1| 2| 2| 2| 2| 2| | 1| 5| 3| 5| 9| 9| 6| 7| 3| 9| 0| 0| 0| 0| 1| 5| 6| 9| 7| 7| 1| 4| 4| 4| 7| __________________________________________|__________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0 MG/KG | 3| 3| 3| 0| 1| 5| 1| 0| 4| 0| 2| 1| 1| 4| 1| 1| 3| 2| 2| 4| 1| 1| 2| 3| 0| | 3| 9| 8| 3| 9| 0| 4| 1| 0| 9| 3| 7| 1| 3| 3| 8| 1| 7| 9| 1| 6| 5| 0| 0| 4| __________________________________________|__________________________________________________________________________| GENITAL SYSTEM - cont | | | | Preputial Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| Adenoma | | Carcinoma | X | |__________________________________________________________________________| Prostate | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Seminal Vesicle | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Testes | + + + + + + + + + + + + + + + + + + + + + + + + +| Bilateral, Interstitial Cell, Adenoma| X X X X X X X X X X X X X X| Interstitial Cell, Adenoma | X X X X X | _____________________________________________________________________________________________________________________| HEMATOPOIETIC SYSTEM | | |__________________________________________________________________________| Bone Marrow | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Lymph Node | + + + + + + + | Deep Cervical, Carcinoma, Metastatic,| | Thyroid Gland | X | Mediastinal, Carcinoma, Metastatic, | | Thyroid Gland | X | |__________________________________________________________________________| Lymph Node, Mandibular | + M M M + M M + M M M M + M M M M M M M M M + M M| |__________________________________________________________________________| Lymph Node, Mesenteric | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Spleen | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Thymus | + + + + + M + + + + + + + M + + + + + + + + + + +| _____________________________________________________________________________________________________________________| INTEGUMENTARY SYSTEM | | |__________________________________________________________________________| Mammary Gland | M + + + + + + + + + + + + + + + + + + + + + + + +| Adenoma | | Fibroadenoma | X X | Fibroma | | __________________________________________|__________________________________________________________________________| Page 37 NTP Experiment-Test: 88122-06 NEOPLASMS BY INDIVIDUAL ANIMAL (SYSTEMIC LESIONS ABRIDGED) Report: PEIRPT17 Study Type: CHRONIC ELMIRON Date: 06/12/01 Route: GAVAGE Time: 09:26:59 _____________________________________________________________________________________________________________________ | 1| 4| 5| 5| 5| 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 7| 7| DAY ON TEST | 1| 7| 0| 0| 1| 1| 2| 4| 7| 8| 0| 3| 4| 4| 6| 8| 8| 9| 0| 1| 2| 2| 2| 2| 2| | 1| 5| 3| 5| 9| 9| 6| 7| 3| 9| 0| 0| 0| 0| 1| 5| 6| 9| 7| 7| 1| 4| 4| 4| 7| __________________________________________|__________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0 MG/KG | 3| 3| 3| 0| 1| 5| 1| 0| 4| 0| 2| 1| 1| 4| 1| 1| 3| 2| 2| 4| 1| 1| 2| 3| 0| | 3| 9| 8| 3| 9| 0| 4| 1| 0| 9| 3| 7| 1| 3| 3| 8| 1| 7| 9| 1| 6| 5| 0| 0| 4| __________________________________________|__________________________________________________________________________| INTEGUMENTARY SYSTEM - cont | | | | |__________________________________________________________________________| Skin | + + + + + + + + + + + + + + + + + + + + + + + + +| Basal Cell Adenoma | | Keratoacanthoma | | Squamous Cell Papilloma | | Sebaceous Gland, Adenoma | | Subcutaneous Tissue, Fibroma | | Subcutaneous Tissue, Fibrosarcoma | X | Subcutaneous Tissue, Lipoma | | _____________________________________________________________________________________________________________________| MUSCULOSKELETAL SYSTEM | | |__________________________________________________________________________| Bone | + + + + + + + + + + + + + + + + + + + + + + + + +| Vertebra, Chordoma | X | _____________________________________________________________________________________________________________________| NERVOUS SYSTEM | | |__________________________________________________________________________| Brain | + + + + + + + + + + + + + + + + + + + + + + + + +| Carcinoma, Metastatic, Pituitary | | Gland | X | _____________________________________________________________________________________________________________________| RESPIRATORY SYSTEM | | |__________________________________________________________________________| Lung | + + + + + + + + + + + + + + + + + + + + + + + + +| Alveolar/Bronchiolar Carcinoma | | Alveolar/Bronchiolar Carcinoma, | | Multiple | X | Carcinoma, Metastatic, Thyroid Gland | X | Chordoma, Metastatic, Bone | X | Pheochromocytoma Malignant, | | Metastatic, Adrenal Medulla | | |__________________________________________________________________________| Nose | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Trachea | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| SPECIAL SENSES SYSTEM | | None | | __________________________________________|__________________________________________________________________________| Page 38 NTP Experiment-Test: 88122-06 NEOPLASMS BY INDIVIDUAL ANIMAL (SYSTEMIC LESIONS ABRIDGED) Report: PEIRPT17 Study Type: CHRONIC ELMIRON Date: 06/12/01 Route: GAVAGE Time: 09:26:59 _____________________________________________________________________________________________________________________ | 1| 4| 5| 5| 5| 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 7| 7| DAY ON TEST | 1| 7| 0| 0| 1| 1| 2| 4| 7| 8| 0| 3| 4| 4| 6| 8| 8| 9| 0| 1| 2| 2| 2| 2| 2| | 1| 5| 3| 5| 9| 9| 6| 7| 3| 9| 0| 0| 0| 0| 1| 5| 6| 9| 7| 7| 1| 4| 4| 4| 7| __________________________________________|__________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0 MG/KG | 3| 3| 3| 0| 1| 5| 1| 0| 4| 0| 2| 1| 1| 4| 1| 1| 3| 2| 2| 4| 1| 1| 2| 3| 0| | 3| 9| 8| 3| 9| 0| 4| 1| 0| 9| 3| 7| 1| 3| 3| 8| 1| 7| 9| 1| 6| 5| 0| 0| 4| __________________________________________|__________________________________________________________________________| URINARY SYSTEM | | |__________________________________________________________________________| Kidney | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Ureter | + | |__________________________________________________________________________| Urinary Bladder | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________|__________________________________________________________________________| SYSTEMIC LESIONS | | __________________________________________________________________________| Multiple Organs | + + + + + + + + + + + + + + + + + + + + + + + + +| Leukemia Mononuclear | X X X X X X X X X X | Mesothelioma Malignant | X X | __________________________________________|__________________________________________________________________________| Page 39 NTP Experiment-Test: 88122-06 NEOPLASMS BY INDIVIDUAL ANIMAL (SYSTEMIC LESIONS ABRIDGED) Report: PEIRPT17 Study Type: CHRONIC ELMIRON Date: 06/12/01 Route: GAVAGE Time: 09:26:59 __________________________________________________________________________________________________________________________________ | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| | DAY ON TEST | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| | | 7| 7| 7| 7| 7| 7| 7| 7| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| | __________________________________________|__________________________________________________________________________| T (*) | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| O | FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| T | ANIMAL ID | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| A | 0 MG/KG | 0| 2| 2| 4| 4| 4| 4| 4| 0| 0| 0| 0| 1| 1| 2| 2| 2| 3| 3| 4| 2| 3| 3| 3| 4| L | | 7| 4| 5| 2| 5| 6| 8| 9| 2| 5| 6| 8| 0| 2| 1| 2| 8| 2| 6| 7| 6| 4| 5| 7| 4| | _____________________________________________________________________________________________________________________|____________| ALIMENTARY SYSTEM | | | |__________________________________________________________________________|____________| Esophagus | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Intestine Large, Colon | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Intestine Large, Rectum | + + + + + + + + + + + + + + + + + + + + + + + + +| 48 | Polyp Adenomatous | X | 1 | |__________________________________________________________________________|____________| Intestine Large, Cecum | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Intestine Small, Duodenum | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Intestine Small, Jejunum | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Intestine Small, Ileum | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Liver | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Mesentery | + + + + | 9 | |__________________________________________________________________________|____________| Pancreas | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Salivary Glands | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Schwannoma Malignant | | 1 | |__________________________________________________________________________|____________| Stomach, Forestomach | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Stomach, Glandular | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Leiomyosarcoma | X | 1 | _____________________________________________________________________________________________________________________| | CARDIOVASCULAR SYSTEM | | | |__________________________________________________________________________|____________| Blood Vessel | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | _____________________________________________________________________________________________________________________|____________| * : Total animals with tissue examined microscopically; total animals with tumor + : Tissue examined microscopically M : Missing tissue X : Lesion present A : Autolysis precludes evaluation I : Insufficient tissue BLANK : Not examined microscopically Page 40 NTP Experiment-Test: 88122-06 NEOPLASMS BY INDIVIDUAL ANIMAL (SYSTEMIC LESIONS ABRIDGED) Report: PEIRPT17 Study Type: CHRONIC ELMIRON Date: 06/12/01 Route: GAVAGE Time: 09:26:59 __________________________________________________________________________________________________________________________________ | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| | DAY ON TEST | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| | | 7| 7| 7| 7| 7| 7| 7| 7| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| | __________________________________________|__________________________________________________________________________| T (*) | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| O | FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| T | ANIMAL ID | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| A | 0 MG/KG | 0| 2| 2| 4| 4| 4| 4| 4| 0| 0| 0| 0| 1| 1| 2| 2| 2| 3| 3| 4| 2| 3| 3| 3| 4| L | | 7| 4| 5| 2| 5| 6| 8| 9| 2| 5| 6| 8| 0| 2| 1| 2| 8| 2| 6| 7| 6| 4| 5| 7| 4| | _____________________________________________________________________________________________________________________|____________| CARDIOVASCULAR SYSTEM - cont | | | | | | |__________________________________________________________________________|____________| Heart | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | _____________________________________________________________________________________________________________________| | ENDOCRINE SYSTEM | | | |__________________________________________________________________________|____________| Adrenal Cortex | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Adrenal Medulla | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Pheochromocytoma Malignant | X | 1 | Pheochromocytoma Benign | X X X X | 6 | Bilateral, Pheochromocytoma Benign | | 1 | |__________________________________________________________________________|____________| Islets, Pancreatic | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Adenoma | X | 1 | |__________________________________________________________________________|____________| Parathyroid Gland | + + + + + + + + + + + M + + + + + + M + + + + M +| 46 | |__________________________________________________________________________|____________| Pituitary Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Pars Distalis, Adenoma | X X X X X X X X X X X X | 19 | Pars Distalis, Carcinoma | | 1 | Pars Intermedia, Adenoma | X | 1 | |__________________________________________________________________________|____________| Thyroid Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Bilateral, C-Cell, Adenoma | | 1 | Bilateral, C-Cell, Carcinoma | | 1 | C-Cell, Adenoma | X X X X | 5 | C-Cell, Adenoma, Multiple | X X | 2 | C-Cell, Carcinoma | | 1 | Follicle, Carcinoma | X X | 2 | _____________________________________________________________________________________________________________________| | GENERAL BODY SYSTEM | | | |__________________________________________________________________________|____________| _____________________________________________________________________________________________________________________|____________| * : Total animals with tissue examined microscopically; total animals with tumor + : Tissue examined microscopically M : Missing tissue X : Lesion present A : Autolysis precludes evaluation I : Insufficient tissue BLANK : Not examined microscopically Page 41 NTP Experiment-Test: 88122-06 NEOPLASMS BY INDIVIDUAL ANIMAL (SYSTEMIC LESIONS ABRIDGED) Report: PEIRPT17 Study Type: CHRONIC ELMIRON Date: 06/12/01 Route: GAVAGE Time: 09:26:59 __________________________________________________________________________________________________________________________________ | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| | DAY ON TEST | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| | | 7| 7| 7| 7| 7| 7| 7| 7| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| | __________________________________________|__________________________________________________________________________| T (*) | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| O | FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| T | ANIMAL ID | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| A | 0 MG/KG | 0| 2| 2| 4| 4| 4| 4| 4| 0| 0| 0| 0| 1| 1| 2| 2| 2| 3| 3| 4| 2| 3| 3| 3| 4| L | | 7| 4| 5| 2| 5| 6| 8| 9| 2| 5| 6| 8| 0| 2| 1| 2| 8| 2| 6| 7| 6| 4| 5| 7| 4| | _____________________________________________________________________________________________________________________|____________| GENERAL BODY SYSTEM - cont | | | | | | Tissue NOS | + | 1 | _____________________________________________________________________________________________________________________| | GENITAL SYSTEM | | | |__________________________________________________________________________|____________| Coagulating Gland | | 1 | |__________________________________________________________________________|____________| Epididymis | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Preputial Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Adenoma | X | 1 | Carcinoma | | 1 | |__________________________________________________________________________|____________| Prostate | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Seminal Vesicle | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Testes | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Bilateral, Interstitial Cell, Adenoma| X X X X X X X X X X X X X X X X X X X X X | 35 | Interstitial Cell, Adenoma | X X X X| 9 | _____________________________________________________________________________________________________________________| | HEMATOPOIETIC SYSTEM | | | |__________________________________________________________________________|____________| Bone Marrow | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Lymph Node | + + + + | 11 | Deep Cervical, Carcinoma, Metastatic,| | | Thyroid Gland | | 1 | Mediastinal, Carcinoma, Metastatic, | | | Thyroid Gland | | 1 | |__________________________________________________________________________|____________| Lymph Node, Mandibular | M M M M M M M M M M M M M M M M M M M M M M M M M| 5 | |__________________________________________________________________________|____________| _____________________________________________________________________________________________________________________|____________| * : Total animals with tissue examined microscopically; total animals with tumor + : Tissue examined microscopically M : Missing tissue X : Lesion present A : Autolysis precludes evaluation I : Insufficient tissue BLANK : Not examined microscopically Page 42 NTP Experiment-Test: 88122-06 NEOPLASMS BY INDIVIDUAL ANIMAL (SYSTEMIC LESIONS ABRIDGED) Report: PEIRPT17 Study Type: CHRONIC ELMIRON Date: 06/12/01 Route: GAVAGE Time: 09:26:59 __________________________________________________________________________________________________________________________________ | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| | DAY ON TEST | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| | | 7| 7| 7| 7| 7| 7| 7| 7| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| | __________________________________________|__________________________________________________________________________| T (*) | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| O | FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| T | ANIMAL ID | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| A | 0 MG/KG | 0| 2| 2| 4| 4| 4| 4| 4| 0| 0| 0| 0| 1| 1| 2| 2| 2| 3| 3| 4| 2| 3| 3| 3| 4| L | | 7| 4| 5| 2| 5| 6| 8| 9| 2| 5| 6| 8| 0| 2| 1| 2| 8| 2| 6| 7| 6| 4| 5| 7| 4| | _____________________________________________________________________________________________________________________|____________| HEMATOPOIETIC SYSTEM - cont | | | | | | Lymph Node, Mesenteric | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Spleen | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Thymus | + + + + + + + + + + + M + + + + + + + + + + M M +| 45 | _____________________________________________________________________________________________________________________| | INTEGUMENTARY SYSTEM | | | |__________________________________________________________________________|____________| Mammary Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| 49 | Adenoma | X | 1 | Fibroadenoma | | 2 | Fibroma | X | 1 | |__________________________________________________________________________|____________| Skin | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Basal Cell Adenoma | X | 1 | Keratoacanthoma | X X | 2 | Squamous Cell Papilloma | X | 1 | Sebaceous Gland, Adenoma | X | 1 | Subcutaneous Tissue, Fibroma | X | 1 | Subcutaneous Tissue, Fibrosarcoma | X | 2 | Subcutaneous Tissue, Lipoma | X | 1 | _____________________________________________________________________________________________________________________| | MUSCULOSKELETAL SYSTEM | | | |__________________________________________________________________________|____________| Bone | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Vertebra, Chordoma | | 1 | _____________________________________________________________________________________________________________________| | NERVOUS SYSTEM | | | |__________________________________________________________________________|____________| Brain | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Carcinoma, Metastatic, Pituitary | | | Gland | | 1 | _____________________________________________________________________________________________________________________|____________| * : Total animals with tissue examined microscopically; total animals with tumor + : Tissue examined microscopically M : Missing tissue X : Lesion present A : Autolysis precludes evaluation I : Insufficient tissue BLANK : Not examined microscopically Page 43 NTP Experiment-Test: 88122-06 NEOPLASMS BY INDIVIDUAL ANIMAL (SYSTEMIC LESIONS ABRIDGED) Report: PEIRPT17 Study Type: CHRONIC ELMIRON Date: 06/12/01 Route: GAVAGE Time: 09:26:59 __________________________________________________________________________________________________________________________________ | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| | DAY ON TEST | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| | | 7| 7| 7| 7| 7| 7| 7| 7| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| | __________________________________________|__________________________________________________________________________| T (*) | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| O | FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| T | ANIMAL ID | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| A | 0 MG/KG | 0| 2| 2| 4| 4| 4| 4| 4| 0| 0| 0| 0| 1| 1| 2| 2| 2| 3| 3| 4| 2| 3| 3| 3| 4| L | | 7| 4| 5| 2| 5| 6| 8| 9| 2| 5| 6| 8| 0| 2| 1| 2| 8| 2| 6| 7| 6| 4| 5| 7| 4| | _____________________________________________________________________________________________________________________|____________| NERVOUS SYSTEM - cont | | | | | | _____________________________________________________________________________________________________________________| | RESPIRATORY SYSTEM | | | |__________________________________________________________________________|____________| Lung | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Alveolar/Bronchiolar Carcinoma | X | 1 | Alveolar/Bronchiolar Carcinoma, | | | Multiple | | 1 | Carcinoma, Metastatic, Thyroid Gland | | 1 | Chordoma, Metastatic, Bone | | 1 | Pheochromocytoma Malignant, | | | Metastatic, Adrenal Medulla | X | 1 | |__________________________________________________________________________|____________| Nose | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Trachea | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | _____________________________________________________________________________________________________________________| | SPECIAL SENSES SYSTEM | | | None | | | _____________________________________________________________________________________________________________________| | URINARY SYSTEM | | | |__________________________________________________________________________|____________| Kidney | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Ureter | | 1 | |__________________________________________________________________________|____________| Urinary Bladder | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | __________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS | | | __________________________________________________________________________|____________| Multiple Organs | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Leukemia Mononuclear | X X X X X| 15 | Mesothelioma Malignant | | 2 | __________________________________________________________________________________________________________________________________ * : Total animals with tissue examined microscopically; total animals with tumor + : Tissue examined microscopically M : Missing tissue X : Lesion present A : Autolysis precludes evaluation I : Insufficient tissue BLANK : Not examined microscopically Page 44 NTP Experiment-Test: 88122-06 NEOPLASMS BY INDIVIDUAL ANIMAL (SYSTEMIC LESIONS ABRIDGED) Report: PEIRPT17 Study Type: CHRONIC ELMIRON Date: 06/12/01 Route: GAVAGE Time: 09:26:59 _____________________________________________________________________________________________________________________ | 1| 2| 3| 4| 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| DAY ON TEST | 3| 2| 1| 7| 0| 3| 5| 7| 7| 4| 4| 5| 6| 7| 0| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| | 1| 3| 3| 8| 3| 3| 1| 4| 7| 5| 5| 4| 8| 4| 5| 3| 3| 5| 7| 9| 4| 7| 7| 7| 7| __________________________________________|__________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 1| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 14 MG/KG | 7| 6| 7| 5| 9| 5| 8| 6| 9| 5| 9| 5| 6| 0| 8| 8| 9| 9| 6| 5| 9| 6| 6| 7| 7| | 9| 1| 1| 5| 3| 8| 4| 2| 8| 6| 0| 4| 7| 0| 0| 6| 5| 9| 0| 7| 2| 4| 6| 3| 7| __________________________________________|__________________________________________________________________________| ALIMENTARY SYSTEM | | |__________________________________________________________________________| Esophagus | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Intestine Large, Colon | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Intestine Large, Rectum | + A + + + + + + + + + + + + + + + + + A + + + + +| Polyp Adenomatous | | |__________________________________________________________________________| Intestine Large, Cecum | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Intestine Small, Duodenum | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Intestine Small, Jejunum | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Intestine Small, Ileum | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Liver | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Mesentery | + + + + | Schwannoma Malignant | | |__________________________________________________________________________| Pancreas | + + + + + + + + + + + + + + + + + + + + + + + + +| Acinus, Carcinoma | | |__________________________________________________________________________| Salivary Glands | + + + + + + + + + + + + + + + + + + + + + + + + +| Schwannoma Malignant | X X | |__________________________________________________________________________| Stomach, Forestomach | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Stomach, Glandular | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Tongue | + | Squamous Cell Papilloma | X | _____________________________________________________________________________________________________________________| CARDIOVASCULAR SYSTEM | | |__________________________________________________________________________| Blood Vessel | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________|__________________________________________________________________________| Page 45 NTP Experiment-Test: 88122-06 NEOPLASMS BY INDIVIDUAL ANIMAL (SYSTEMIC LESIONS ABRIDGED) Report: PEIRPT17 Study Type: CHRONIC ELMIRON Date: 06/12/01 Route: GAVAGE Time: 09:26:59 _____________________________________________________________________________________________________________________ | 1| 2| 3| 4| 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| DAY ON TEST | 3| 2| 1| 7| 0| 3| 5| 7| 7| 4| 4| 5| 6| 7| 0| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| | 1| 3| 3| 8| 3| 3| 1| 4| 7| 5| 5| 4| 8| 4| 5| 3| 3| 5| 7| 9| 4| 7| 7| 7| 7| __________________________________________|__________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 1| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 14 MG/KG | 7| 6| 7| 5| 9| 5| 8| 6| 9| 5| 9| 5| 6| 0| 8| 8| 9| 9| 6| 5| 9| 6| 6| 7| 7| | 9| 1| 1| 5| 3| 8| 4| 2| 8| 6| 0| 4| 7| 0| 0| 6| 5| 9| 0| 7| 2| 4| 6| 3| 7| __________________________________________|__________________________________________________________________________| CARDIOVASCULAR SYSTEM - cont | | | | |__________________________________________________________________________| Heart | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| ENDOCRINE SYSTEM | | |__________________________________________________________________________| Adrenal Cortex | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Adrenal Medulla | + + + + + + + + + + + + + + + + + + + + + + + + +| Pheochromocytoma Benign | | Bilateral, Pheochromocytoma Benign | X | |__________________________________________________________________________| Islets, Pancreatic | + + + + + + + + + + + + + + + + + + + + + + + + +| Adenoma | X | Carcinoma | X | |__________________________________________________________________________| Parathyroid Gland | + + + + + M + + + + + M + + M + + + + + + + + + +| |__________________________________________________________________________| Pituitary Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| Pars Distalis, Adenoma | X X X X X X X X X | |__________________________________________________________________________| Thyroid Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| Bilateral, C-Cell, Adenoma | | Bilateral, Follicle, Carcinoma | X | C-Cell, Adenoma | X X | C-Cell, Carcinoma | X | Follicle, Adenoma | | _____________________________________________________________________________________________________________________| GENERAL BODY SYSTEM | | None | | _____________________________________________________________________________________________________________________| GENITAL SYSTEM | | |__________________________________________________________________________| Epididymis | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Preputial Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| Adenoma | X | __________________________________________|__________________________________________________________________________| Page 46 NTP Experiment-Test: 88122-06 NEOPLASMS BY INDIVIDUAL ANIMAL (SYSTEMIC LESIONS ABRIDGED) Report: PEIRPT17 Study Type: CHRONIC ELMIRON Date: 06/12/01 Route: GAVAGE Time: 09:26:59 _____________________________________________________________________________________________________________________ | 1| 2| 3| 4| 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| DAY ON TEST | 3| 2| 1| 7| 0| 3| 5| 7| 7| 4| 4| 5| 6| 7| 0| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| | 1| 3| 3| 8| 3| 3| 1| 4| 7| 5| 5| 4| 8| 4| 5| 3| 3| 5| 7| 9| 4| 7| 7| 7| 7| __________________________________________|__________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 1| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 14 MG/KG | 7| 6| 7| 5| 9| 5| 8| 6| 9| 5| 9| 5| 6| 0| 8| 8| 9| 9| 6| 5| 9| 6| 6| 7| 7| | 9| 1| 1| 5| 3| 8| 4| 2| 8| 6| 0| 4| 7| 0| 0| 6| 5| 9| 0| 7| 2| 4| 6| 3| 7| __________________________________________|__________________________________________________________________________| GENITAL SYSTEM - cont | | | | |__________________________________________________________________________| Prostate | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Seminal Vesicle | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Testes | + + + + + + + + + + + + + + + + + + + + + + + + +| Bilateral, Interstitial Cell, Adenoma| X X X X X X X X X X X X X X X| Interstitial Cell, Adenoma | X X X X | _____________________________________________________________________________________________________________________| HEMATOPOIETIC SYSTEM | | |__________________________________________________________________________| Bone Marrow | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Lymph Node | + + + + + + + + + + + | |__________________________________________________________________________| Lymph Node, Mandibular | M M M M M M M M M M M M M M M M + M M M M M M M M| |__________________________________________________________________________| Lymph Node, Mesenteric | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Spleen | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Thymus | + + + + + + + + + + M M + + + + + + + + + M + + +| _____________________________________________________________________________________________________________________| INTEGUMENTARY SYSTEM | | |__________________________________________________________________________| Mammary Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| Fibroadenoma | | |__________________________________________________________________________| Skin | + + + + + + + + + + + + + + + + + + + + + + + + +| Keratoacanthoma | X | Squamous Cell Carcinoma | | Sebaceous Gland, Adenoma | | Subcutaneous Tissue, Fibroma | | Subcutaneous Tissue, Fibrosarcoma | | Subcutaneous Tissue, Hemangiosarcoma | X | Subcutaneous Tissue, Lipoma | | __________________________________________|__________________________________________________________________________| Page 47 NTP Experiment-Test: 88122-06 NEOPLASMS BY INDIVIDUAL ANIMAL (SYSTEMIC LESIONS ABRIDGED) Report: PEIRPT17 Study Type: CHRONIC ELMIRON Date: 06/12/01 Route: GAVAGE Time: 09:26:59 _____________________________________________________________________________________________________________________ | 1| 2| 3| 4| 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| DAY ON TEST | 3| 2| 1| 7| 0| 3| 5| 7| 7| 4| 4| 5| 6| 7| 0| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| | 1| 3| 3| 8| 3| 3| 1| 4| 7| 5| 5| 4| 8| 4| 5| 3| 3| 5| 7| 9| 4| 7| 7| 7| 7| __________________________________________|__________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 1| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 14 MG/KG | 7| 6| 7| 5| 9| 5| 8| 6| 9| 5| 9| 5| 6| 0| 8| 8| 9| 9| 6| 5| 9| 6| 6| 7| 7| | 9| 1| 1| 5| 3| 8| 4| 2| 8| 6| 0| 4| 7| 0| 0| 6| 5| 9| 0| 7| 2| 4| 6| 3| 7| __________________________________________|__________________________________________________________________________| MUSCULOSKELETAL SYSTEM | | |__________________________________________________________________________| Bone | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| NERVOUS SYSTEM | | |__________________________________________________________________________| Brain | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| RESPIRATORY SYSTEM | | |__________________________________________________________________________| Lung | + + + + + + + + + + + + + + + + + + + + + + + + +| Alveolar/Bronchiolar Adenoma | X | Carcinoma, Metastatic, Thyroid Gland | X | Schwannoma Malignant, Metastatic, | | Salivary Glands | X | |__________________________________________________________________________| Nose | + + + + + + + + + + + + + + + + + + + + + + + + +| Respiratory Epithelium, Adenoma | X | |__________________________________________________________________________| Trachea | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| SPECIAL SENSES SYSTEM | | |__________________________________________________________________________| Eye | + | _____________________________________________________________________________________________________________________| URINARY SYSTEM | | |__________________________________________________________________________| Kidney | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Urinary Bladder | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________|__________________________________________________________________________| SYSTEMIC LESIONS | | __________________________________________________________________________| Multiple Organs | + + + + + + + + + + + + + + + + + + + + + + + + +| Leukemia Mononuclear | X X X X X X X X X X X X | __________________________________________|__________________________________________________________________________| Page 48 NTP Experiment-Test: 88122-06 NEOPLASMS BY INDIVIDUAL ANIMAL (SYSTEMIC LESIONS ABRIDGED) Report: PEIRPT17 Study Type: CHRONIC ELMIRON Date: 06/12/01 Route: GAVAGE Time: 09:26:59 __________________________________________________________________________________________________________________________________ | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| | DAY ON TEST | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| | | 7| 7| 7| 7| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 9| | __________________________________________|__________________________________________________________________________| T (*) | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| O | FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| T | ANIMAL ID | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| A | 14 MG/KG | 8| 8| 8| 9| 5| 6| 6| 6| 6| 7| 7| 7| 7| 7| 8| 8| 8| 8| 9| 5| 5| 5| 7| 9| 9| L | | 2| 3| 5| 1| 9| 3| 5| 8| 9| 0| 2| 4| 6| 8| 1| 7| 8| 9| 7| 1| 2| 3| 5| 4| 6| | _____________________________________________________________________________________________________________________|____________| ALIMENTARY SYSTEM | | | |__________________________________________________________________________|____________| Esophagus | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Intestine Large, Colon | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Intestine Large, Rectum | + + + + + + + + + + + + + + + + + + + + + + + + +| 48 | Polyp Adenomatous | X | 1 | |__________________________________________________________________________|____________| Intestine Large, Cecum | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Intestine Small, Duodenum | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Intestine Small, Jejunum | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Intestine Small, Ileum | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Liver | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Mesentery | + + + + + + + | 11 | Schwannoma Malignant | X | 1 | |__________________________________________________________________________|____________| Pancreas | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Acinus, Carcinoma | X | 1 | |__________________________________________________________________________|____________| Salivary Glands | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Schwannoma Malignant | | 2 | |__________________________________________________________________________|____________| Stomach, Forestomach | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Stomach, Glandular | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Tongue | | 1 | Squamous Cell Papilloma | | 1 | _____________________________________________________________________________________________________________________|____________| * : Total animals with tissue examined microscopically; total animals with tumor + : Tissue examined microscopically M : Missing tissue X : Lesion present A : Autolysis precludes evaluation I : Insufficient tissue BLANK : Not examined microscopically Page 49 NTP Experiment-Test: 88122-06 NEOPLASMS BY INDIVIDUAL ANIMAL (SYSTEMIC LESIONS ABRIDGED) Report: PEIRPT17 Study Type: CHRONIC ELMIRON Date: 06/12/01 Route: GAVAGE Time: 09:26:59 __________________________________________________________________________________________________________________________________ | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| | DAY ON TEST | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| | | 7| 7| 7| 7| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 9| | __________________________________________|__________________________________________________________________________| T (*) | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| O | FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| T | ANIMAL ID | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| A | 14 MG/KG | 8| 8| 8| 9| 5| 6| 6| 6| 6| 7| 7| 7| 7| 7| 8| 8| 8| 8| 9| 5| 5| 5| 7| 9| 9| L | | 2| 3| 5| 1| 9| 3| 5| 8| 9| 0| 2| 4| 6| 8| 1| 7| 8| 9| 7| 1| 2| 3| 5| 4| 6| | _____________________________________________________________________________________________________________________|____________| CARDIOVASCULAR SYSTEM | | | |__________________________________________________________________________|____________| Blood Vessel | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Heart | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | _____________________________________________________________________________________________________________________| | ENDOCRINE SYSTEM | | | |__________________________________________________________________________|____________| Adrenal Cortex | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Adrenal Medulla | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Pheochromocytoma Benign | X X X X X X | 6 | Bilateral, Pheochromocytoma Benign | | 1 | |__________________________________________________________________________|____________| Islets, Pancreatic | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Adenoma | | 1 | Carcinoma | | 1 | |__________________________________________________________________________|____________| Parathyroid Gland | + + + + + + + + + + + + + M + M + + + + M + + + +| 44 | |__________________________________________________________________________|____________| Pituitary Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Pars Distalis, Adenoma | X X X X X X X X X| 18 | |__________________________________________________________________________|____________| Thyroid Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Bilateral, C-Cell, Adenoma | X | 1 | Bilateral, Follicle, Carcinoma | | 1 | C-Cell, Adenoma | X X X X X| 7 | C-Cell, Carcinoma | | 1 | Follicle, Adenoma | X | 1 | _____________________________________________________________________________________________________________________| | GENERAL BODY SYSTEM | | | None | | | _____________________________________________________________________________________________________________________| | GENITAL SYSTEM | | | _____________________________________________________________________________________________________________________|____________| * : Total animals with tissue examined microscopically; total animals with tumor + : Tissue examined microscopically M : Missing tissue X : Lesion present A : Autolysis precludes evaluation I : Insufficient tissue BLANK : Not examined microscopically Page 50 NTP Experiment-Test: 88122-06 NEOPLASMS BY INDIVIDUAL ANIMAL (SYSTEMIC LESIONS ABRIDGED) Report: PEIRPT17 Study Type: CHRONIC ELMIRON Date: 06/12/01 Route: GAVAGE Time: 09:26:59 __________________________________________________________________________________________________________________________________ | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| | DAY ON TEST | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| | | 7| 7| 7| 7| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 9| | __________________________________________|__________________________________________________________________________| T (*) | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| O | FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| T | ANIMAL ID | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| A | 14 MG/KG | 8| 8| 8| 9| 5| 6| 6| 6| 6| 7| 7| 7| 7| 7| 8| 8| 8| 8| 9| 5| 5| 5| 7| 9| 9| L | | 2| 3| 5| 1| 9| 3| 5| 8| 9| 0| 2| 4| 6| 8| 1| 7| 8| 9| 7| 1| 2| 3| 5| 4| 6| | _____________________________________________________________________________________________________________________|____________| GENITAL SYSTEM - cont | | | | | | |__________________________________________________________________________|____________| Epididymis | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Preputial Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Adenoma | | 1 | |__________________________________________________________________________|____________| Prostate | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Seminal Vesicle | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Testes | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Bilateral, Interstitial Cell, Adenoma| X X X X X X X X X X X X X X X X X X X X X X| 37 | Interstitial Cell, Adenoma | X X | 6 | _____________________________________________________________________________________________________________________| | HEMATOPOIETIC SYSTEM | | | |__________________________________________________________________________|____________| Bone Marrow | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Lymph Node | + + + + + + | 17 | |__________________________________________________________________________|____________| Lymph Node, Mandibular | M + M + M M M M M M M M M M M M M M M M M + M M +| 5 | |__________________________________________________________________________|____________| Lymph Node, Mesenteric | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Spleen | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Thymus | + + + M + M + + + + + + + + + + + + + + + + M + +| 44 | _____________________________________________________________________________________________________________________| | INTEGUMENTARY SYSTEM | | | |__________________________________________________________________________|____________| Mammary Gland | + + + + + M + + + + + + + + + + + + + + + + + + +| 49 | Fibroadenoma | X | 1 | _____________________________________________________________________________________________________________________|____________| * : Total animals with tissue examined microscopically; total animals with tumor + : Tissue examined microscopically M : Missing tissue X : Lesion present A : Autolysis precludes evaluation I : Insufficient tissue BLANK : Not examined microscopically Page 51 NTP Experiment-Test: 88122-06 NEOPLASMS BY INDIVIDUAL ANIMAL (SYSTEMIC LESIONS ABRIDGED) Report: PEIRPT17 Study Type: CHRONIC ELMIRON Date: 06/12/01 Route: GAVAGE Time: 09:26:59 __________________________________________________________________________________________________________________________________ | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| | DAY ON TEST | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| | | 7| 7| 7| 7| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 9| | __________________________________________|__________________________________________________________________________| T (*) | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| O | FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| T | ANIMAL ID | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| A | 14 MG/KG | 8| 8| 8| 9| 5| 6| 6| 6| 6| 7| 7| 7| 7| 7| 8| 8| 8| 8| 9| 5| 5| 5| 7| 9| 9| L | | 2| 3| 5| 1| 9| 3| 5| 8| 9| 0| 2| 4| 6| 8| 1| 7| 8| 9| 7| 1| 2| 3| 5| 4| 6| | _____________________________________________________________________________________________________________________|____________| INTEGUMENTARY SYSTEM - cont | | | | | | |__________________________________________________________________________|____________| Skin | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Keratoacanthoma | X X | 3 | Squamous Cell Carcinoma | X | 1 | Sebaceous Gland, Adenoma | X | 1 | Subcutaneous Tissue, Fibroma | X| 1 | Subcutaneous Tissue, Fibrosarcoma | X X | 2 | Subcutaneous Tissue, Hemangiosarcoma | | 1 | Subcutaneous Tissue, Lipoma | X | 1 | _____________________________________________________________________________________________________________________| | MUSCULOSKELETAL SYSTEM | | | |__________________________________________________________________________|____________| Bone | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | _____________________________________________________________________________________________________________________| | NERVOUS SYSTEM | | | |__________________________________________________________________________|____________| Brain | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | _____________________________________________________________________________________________________________________| | RESPIRATORY SYSTEM | | | |__________________________________________________________________________|____________| Lung | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Alveolar/Bronchiolar Adenoma | | 1 | Carcinoma, Metastatic, Thyroid Gland | | 1 | Schwannoma Malignant, Metastatic, | | | Salivary Glands | | 1 | |__________________________________________________________________________|____________| Nose | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Respiratory Epithelium, Adenoma | | 1 | |__________________________________________________________________________|____________| Trachea | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | _____________________________________________________________________________________________________________________| | SPECIAL SENSES SYSTEM | | | _____________________________________________________________________________________________________________________|____________| * : Total animals with tissue examined microscopically; total animals with tumor + : Tissue examined microscopically M : Missing tissue X : Lesion present A : Autolysis precludes evaluation I : Insufficient tissue BLANK : Not examined microscopically Page 52 NTP Experiment-Test: 88122-06 NEOPLASMS BY INDIVIDUAL ANIMAL (SYSTEMIC LESIONS ABRIDGED) Report: PEIRPT17 Study Type: CHRONIC ELMIRON Date: 06/12/01 Route: GAVAGE Time: 09:26:59 __________________________________________________________________________________________________________________________________ | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| | DAY ON TEST | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| | | 7| 7| 7| 7| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 9| | __________________________________________|__________________________________________________________________________| T (*) | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| O | FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| T | ANIMAL ID | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| A | 14 MG/KG | 8| 8| 8| 9| 5| 6| 6| 6| 6| 7| 7| 7| 7| 7| 8| 8| 8| 8| 9| 5| 5| 5| 7| 9| 9| L | | 2| 3| 5| 1| 9| 3| 5| 8| 9| 0| 2| 4| 6| 8| 1| 7| 8| 9| 7| 1| 2| 3| 5| 4| 6| | _____________________________________________________________________________________________________________________|____________| SPECIAL SENSES SYSTEM - cont | | | | | | |__________________________________________________________________________|____________| Eye | | 1 | _____________________________________________________________________________________________________________________| | URINARY SYSTEM | | | |__________________________________________________________________________|____________| Kidney | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Urinary Bladder | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | __________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS | | | __________________________________________________________________________|____________| Multiple Organs | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Leukemia Mononuclear | X X X X| 16 | __________________________________________________________________________________________________________________________________ * : Total animals with tissue examined microscopically; total animals with tumor + : Tissue examined microscopically M : Missing tissue X : Lesion present A : Autolysis precludes evaluation I : Insufficient tissue BLANK : Not examined microscopically Page 53 NTP Experiment-Test: 88122-06 NEOPLASMS BY INDIVIDUAL ANIMAL (SYSTEMIC LESIONS ABRIDGED) Report: PEIRPT17 Study Type: CHRONIC ELMIRON Date: 06/12/01 Route: GAVAGE Time: 09:26:59 _____________________________________________________________________________________________________________________ | 4| 4| 4| 4| 5| 5| 5| 5| 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 7| 7| DAY ON TEST | 1| 6| 8| 9| 2| 2| 3| 6| 7| 8| 8| 8| 8| 3| 3| 3| 7| 7| 7| 8| 8| 8| 9| 1| 1| | 9| 2| 4| 2| 1| 6| 3| 1| 4| 2| 2| 6| 7| 0| 0| 0| 4| 4| 9| 5| 6| 6| 5| 6| 7| __________________________________________|__________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 42 MG/KG | 3| 2| 1| 1| 4| 2| 4| 2| 2| 0| 3| 1| 4| 0| 2| 4| 1| 2| 3| 4| 0| 1| 0| 1| 4| | 0| 0| 4| 8| 8| 8| 3| 4| 7| 2| 4| 9| 0| 4| 5| 9| 2| 3| 2| 6| 6| 3| 9| 6| 2| __________________________________________|__________________________________________________________________________| ALIMENTARY SYSTEM | | |__________________________________________________________________________| Esophagus | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Intestine Large, Colon | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Intestine Large, Rectum | A + + + + + + + + + + + + + + + + + + + + + + + +| Histiocytic Sarcoma | X | Polyp Adenomatous | X | |__________________________________________________________________________| Intestine Large, Cecum | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Intestine Small, Duodenum | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Intestine Small, Jejunum | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Intestine Small, Ileum | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Liver | + + + + + + + + + + + + + + + + + + + + + + + + +| Histiocytic Sarcoma | X | |__________________________________________________________________________| Mesentery | + + + + + + | |__________________________________________________________________________| Pancreas | + + + + + + + + + + + + + + + + + + + + + + + + +| Acinus, Adenoma | | |__________________________________________________________________________| Salivary Glands | + + + + + + + + + + + + + + + + + + + + + + M + +| Schwannoma Malignant | X | |__________________________________________________________________________| Stomach, Forestomach | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Stomach, Glandular | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| CARDIOVASCULAR SYSTEM | | |__________________________________________________________________________| Blood Vessel | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Heart | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________|__________________________________________________________________________| Page 54 NTP Experiment-Test: 88122-06 NEOPLASMS BY INDIVIDUAL ANIMAL (SYSTEMIC LESIONS ABRIDGED) Report: PEIRPT17 Study Type: CHRONIC ELMIRON Date: 06/12/01 Route: GAVAGE Time: 09:26:59 _____________________________________________________________________________________________________________________ | 4| 4| 4| 4| 5| 5| 5| 5| 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 7| 7| DAY ON TEST | 1| 6| 8| 9| 2| 2| 3| 6| 7| 8| 8| 8| 8| 3| 3| 3| 7| 7| 7| 8| 8| 8| 9| 1| 1| | 9| 2| 4| 2| 1| 6| 3| 1| 4| 2| 2| 6| 7| 0| 0| 0| 4| 4| 9| 5| 6| 6| 5| 6| 7| __________________________________________|__________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 42 MG/KG | 3| 2| 1| 1| 4| 2| 4| 2| 2| 0| 3| 1| 4| 0| 2| 4| 1| 2| 3| 4| 0| 1| 0| 1| 4| | 0| 0| 4| 8| 8| 8| 3| 4| 7| 2| 4| 9| 0| 4| 5| 9| 2| 3| 2| 6| 6| 3| 9| 6| 2| __________________________________________|__________________________________________________________________________| CARDIOVASCULAR SYSTEM - cont | | | | Histiocytic Sarcoma | X | _____________________________________________________________________________________________________________________| ENDOCRINE SYSTEM | | |__________________________________________________________________________| Adrenal Cortex | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Adrenal Medulla | + + + + + + + + + + + + + + + + + + + + + + + + +| Pheochromocytoma Malignant | X X | Pheochromocytoma Benign | | Bilateral, Pheochromocytoma Benign | | |__________________________________________________________________________| Islets, Pancreatic | + + + + + + + + + + + + + + + + + + + + + + + + +| Adenoma | X | |__________________________________________________________________________| Parathyroid Gland | + M + + M + + M + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Pituitary Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| Pars Distalis, Adenoma | X X X X X X X | |__________________________________________________________________________| Thyroid Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| Schwannoma Malignant, Metastatic, | | Salivary Glands | X | C-Cell, Adenoma | X X | Follicle, Adenoma | | _____________________________________________________________________________________________________________________| GENERAL BODY SYSTEM | | |__________________________________________________________________________| Peritoneum | + | _____________________________________________________________________________________________________________________| GENITAL SYSTEM | | |__________________________________________________________________________| Epididymis | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Preputial Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| Adenoma | | |__________________________________________________________________________| __________________________________________|__________________________________________________________________________| Page 55 NTP Experiment-Test: 88122-06 NEOPLASMS BY INDIVIDUAL ANIMAL (SYSTEMIC LESIONS ABRIDGED) Report: PEIRPT17 Study Type: CHRONIC ELMIRON Date: 06/12/01 Route: GAVAGE Time: 09:26:59 _____________________________________________________________________________________________________________________ | 4| 4| 4| 4| 5| 5| 5| 5| 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 7| 7| DAY ON TEST | 1| 6| 8| 9| 2| 2| 3| 6| 7| 8| 8| 8| 8| 3| 3| 3| 7| 7| 7| 8| 8| 8| 9| 1| 1| | 9| 2| 4| 2| 1| 6| 3| 1| 4| 2| 2| 6| 7| 0| 0| 0| 4| 4| 9| 5| 6| 6| 5| 6| 7| __________________________________________|__________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 42 MG/KG | 3| 2| 1| 1| 4| 2| 4| 2| 2| 0| 3| 1| 4| 0| 2| 4| 1| 2| 3| 4| 0| 1| 0| 1| 4| | 0| 0| 4| 8| 8| 8| 3| 4| 7| 2| 4| 9| 0| 4| 5| 9| 2| 3| 2| 6| 6| 3| 9| 6| 2| __________________________________________|__________________________________________________________________________| GENITAL SYSTEM - cont | | | | Prostate | + + + + + + + + + + + + + + + + + + + + + + + + +| Histiocytic Sarcoma | X | |__________________________________________________________________________| Seminal Vesicle | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Testes | + + + + + + + + + + + + + + + + + + + + + + + + +| Bilateral, Interstitial Cell, Adenoma| X X X X X X X X X X X X X| Interstitial Cell, Adenoma | X X X X X X | _____________________________________________________________________________________________________________________| HEMATOPOIETIC SYSTEM | | |__________________________________________________________________________| Bone Marrow | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Lymph Node | + + + + + | |__________________________________________________________________________| Lymph Node, Mandibular | M M M M M M M M M M M M M M M M M M M + + M M M M| |__________________________________________________________________________| Lymph Node, Mesenteric | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Spleen | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Thymus | + + + + + + M M + M + + + + + + + M + + + + + + +| _____________________________________________________________________________________________________________________| INTEGUMENTARY SYSTEM | | |__________________________________________________________________________| Mammary Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| Fibroadenoma | X | |__________________________________________________________________________| Skin | + + + + + + + + + + + + + + + + + + + + + + + + +| Keratoacanthoma | X X X | Squamous Cell Carcinoma | | Sebaceous Gland, Adenoma | | Sebaceous Gland, Carcinoma | X | Subcutaneous Tissue, Fibroma | X | Subcutaneous Tissue, Fibrosarcoma | | _____________________________________________________________________________________________________________________| Page 56 NTP Experiment-Test: 88122-06 NEOPLASMS BY INDIVIDUAL ANIMAL (SYSTEMIC LESIONS ABRIDGED) Report: PEIRPT17 Study Type: CHRONIC ELMIRON Date: 06/12/01 Route: GAVAGE Time: 09:26:59 _____________________________________________________________________________________________________________________ | 4| 4| 4| 4| 5| 5| 5| 5| 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 7| 7| DAY ON TEST | 1| 6| 8| 9| 2| 2| 3| 6| 7| 8| 8| 8| 8| 3| 3| 3| 7| 7| 7| 8| 8| 8| 9| 1| 1| | 9| 2| 4| 2| 1| 6| 3| 1| 4| 2| 2| 6| 7| 0| 0| 0| 4| 4| 9| 5| 6| 6| 5| 6| 7| __________________________________________|__________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 42 MG/KG | 3| 2| 1| 1| 4| 2| 4| 2| 2| 0| 3| 1| 4| 0| 2| 4| 1| 2| 3| 4| 0| 1| 0| 1| 4| | 0| 0| 4| 8| 8| 8| 3| 4| 7| 2| 4| 9| 0| 4| 5| 9| 2| 3| 2| 6| 6| 3| 9| 6| 2| __________________________________________|__________________________________________________________________________| MUSCULOSKELETAL SYSTEM | | |__________________________________________________________________________| Bone | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Skeletal Muscle | + | Histiocytic Sarcoma | X | _____________________________________________________________________________________________________________________| NERVOUS SYSTEM | | |__________________________________________________________________________| Brain | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| RESPIRATORY SYSTEM | | |__________________________________________________________________________| Lung | + + + + + + + + + + + + + + + + + + + + + + + + +| Alveolar/Bronchiolar Adenoma | X | Histiocytic Sarcoma | X | |__________________________________________________________________________| Nose | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Trachea | + + + + + + + + + + + + + + + + + + + + + + + + +| Schwannoma Malignant, Metastatic, | | Salivary Glands | X | _____________________________________________________________________________________________________________________| SPECIAL SENSES SYSTEM | | None | | _____________________________________________________________________________________________________________________| URINARY SYSTEM | | |__________________________________________________________________________| Kidney | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Urinary Bladder | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________|__________________________________________________________________________| SYSTEMIC LESIONS | | __________________________________________________________________________| Multiple Organs | + + + + + + + + + + + + + + + + + + + + + + + + +| Histiocytic Sarcoma | X | Leukemia Mononuclear | X X X X X X X X| Mesothelioma Malignant | | __________________________________________|__________________________________________________________________________| Page 57 NTP Experiment-Test: 88122-06 NEOPLASMS BY INDIVIDUAL ANIMAL (SYSTEMIC LESIONS ABRIDGED) Report: PEIRPT17 Study Type: CHRONIC ELMIRON Date: 06/12/01 Route: GAVAGE Time: 09:26:59 __________________________________________________________________________________________________________________________________ | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| | DAY ON TEST | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| | | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 8| 8| 8| 8| 8| 8| 8| 8| 9| 9| | __________________________________________|__________________________________________________________________________| T (*) | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| O | FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| T | ANIMAL ID | 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| A | 42 MG/KG | 0| 0| 0| 1| 1| 1| 2| 2| 3| 3| 3| 3| 3| 4| 4| 0| 0| 1| 2| 3| 4| 4| 5| 2| 3| L | | 1| 7| 8| 0| 1| 5| 6| 9| 5| 6| 7| 8| 9| 1| 4| 3| 5| 7| 1| 1| 5| 7| 0| 2| 3| | _____________________________________________________________________________________________________________________|____________| ALIMENTARY SYSTEM | | | |__________________________________________________________________________|____________| Esophagus | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Intestine Large, Colon | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Intestine Large, Rectum | + + + + + + + + + + + + + + + + + + + + + + + + +| 49 | Histiocytic Sarcoma | | 1 | Polyp Adenomatous | | 1 | |__________________________________________________________________________|____________| Intestine Large, Cecum | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Intestine Small, Duodenum | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Intestine Small, Jejunum | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Intestine Small, Ileum | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Liver | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Histiocytic Sarcoma | | 1 | |__________________________________________________________________________|____________| Mesentery | + + + | 9 | |__________________________________________________________________________|____________| Pancreas | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Acinus, Adenoma | X | 1 | |__________________________________________________________________________|____________| Salivary Glands | + + + + + + + + + + + + + + + + + + + + + + + + +| 49 | Schwannoma Malignant | | 1 | |__________________________________________________________________________|____________| Stomach, Forestomach | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Stomach, Glandular | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | _____________________________________________________________________________________________________________________| | CARDIOVASCULAR SYSTEM | | | _____________________________________________________________________________________________________________________|____________| * : Total animals with tissue examined microscopically; total animals with tumor + : Tissue examined microscopically M : Missing tissue X : Lesion present A : Autolysis precludes evaluation I : Insufficient tissue BLANK : Not examined microscopically Page 58 NTP Experiment-Test: 88122-06 NEOPLASMS BY INDIVIDUAL ANIMAL (SYSTEMIC LESIONS ABRIDGED) Report: PEIRPT17 Study Type: CHRONIC ELMIRON Date: 06/12/01 Route: GAVAGE Time: 09:26:59 __________________________________________________________________________________________________________________________________ | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| | DAY ON TEST | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| | | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 8| 8| 8| 8| 8| 8| 8| 8| 9| 9| | __________________________________________|__________________________________________________________________________| T (*) | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| O | FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| T | ANIMAL ID | 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| A | 42 MG/KG | 0| 0| 0| 1| 1| 1| 2| 2| 3| 3| 3| 3| 3| 4| 4| 0| 0| 1| 2| 3| 4| 4| 5| 2| 3| L | | 1| 7| 8| 0| 1| 5| 6| 9| 5| 6| 7| 8| 9| 1| 4| 3| 5| 7| 1| 1| 5| 7| 0| 2| 3| | _____________________________________________________________________________________________________________________|____________| CARDIOVASCULAR SYSTEM - cont | | | | | | |__________________________________________________________________________|____________| Blood Vessel | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Heart | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Histiocytic Sarcoma | | 1 | _____________________________________________________________________________________________________________________| | ENDOCRINE SYSTEM | | | |__________________________________________________________________________|____________| Adrenal Cortex | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Adrenal Medulla | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Pheochromocytoma Malignant | X | 3 | Pheochromocytoma Benign | X X | 2 | Bilateral, Pheochromocytoma Benign | X | 1 | |__________________________________________________________________________|____________| Islets, Pancreatic | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Adenoma | | 1 | |__________________________________________________________________________|____________| Parathyroid Gland | + + + + + + + M + + + M + + + + + + + + + + + + +| 45 | |__________________________________________________________________________|____________| Pituitary Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Pars Distalis, Adenoma | X X X X X X X X X X X | 18 | |__________________________________________________________________________|____________| Thyroid Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Schwannoma Malignant, Metastatic, | | | Salivary Glands | | 1 | C-Cell, Adenoma | X X X X X X| 8 | Follicle, Adenoma | X | 1 | _____________________________________________________________________________________________________________________| | GENERAL BODY SYSTEM | | | |__________________________________________________________________________|____________| Peritoneum | | 1 | _____________________________________________________________________________________________________________________|____________| * : Total animals with tissue examined microscopically; total animals with tumor + : Tissue examined microscopically M : Missing tissue X : Lesion present A : Autolysis precludes evaluation I : Insufficient tissue BLANK : Not examined microscopically Page 59 NTP Experiment-Test: 88122-06 NEOPLASMS BY INDIVIDUAL ANIMAL (SYSTEMIC LESIONS ABRIDGED) Report: PEIRPT17 Study Type: CHRONIC ELMIRON Date: 06/12/01 Route: GAVAGE Time: 09:26:59 __________________________________________________________________________________________________________________________________ | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| | DAY ON TEST | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| | | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 8| 8| 8| 8| 8| 8| 8| 8| 9| 9| | __________________________________________|__________________________________________________________________________| T (*) | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| O | FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| T | ANIMAL ID | 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| A | 42 MG/KG | 0| 0| 0| 1| 1| 1| 2| 2| 3| 3| 3| 3| 3| 4| 4| 0| 0| 1| 2| 3| 4| 4| 5| 2| 3| L | | 1| 7| 8| 0| 1| 5| 6| 9| 5| 6| 7| 8| 9| 1| 4| 3| 5| 7| 1| 1| 5| 7| 0| 2| 3| | _____________________________________________________________________________________________________________________|____________| GENITAL SYSTEM | | | |__________________________________________________________________________|____________| Epididymis | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Preputial Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Adenoma | X | 1 | |__________________________________________________________________________|____________| Prostate | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Histiocytic Sarcoma | | 1 | |__________________________________________________________________________|____________| Seminal Vesicle | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Testes | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Bilateral, Interstitial Cell, Adenoma| X X X X X X X X X X X X X X X X X X X X X X X X| 37 | Interstitial Cell, Adenoma | | 6 | _____________________________________________________________________________________________________________________| | HEMATOPOIETIC SYSTEM | | | |__________________________________________________________________________|____________| Bone Marrow | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Lymph Node | + + + + + | 10 | |__________________________________________________________________________|____________| Lymph Node, Mandibular | M M + + + M M M + + M M M M M M M M M M M M + + M| 9 | |__________________________________________________________________________|____________| Lymph Node, Mesenteric | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Spleen | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Thymus | + + + + + + + + + + M M + + + + + + + + + + + + M| 43 | _____________________________________________________________________________________________________________________| | INTEGUMENTARY SYSTEM | | | |__________________________________________________________________________|____________| Mammary Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Fibroadenoma | X X | 3 | _____________________________________________________________________________________________________________________|____________| * : Total animals with tissue examined microscopically; total animals with tumor + : Tissue examined microscopically M : Missing tissue X : Lesion present A : Autolysis precludes evaluation I : Insufficient tissue BLANK : Not examined microscopically Page 60 NTP Experiment-Test: 88122-06 NEOPLASMS BY INDIVIDUAL ANIMAL (SYSTEMIC LESIONS ABRIDGED) Report: PEIRPT17 Study Type: CHRONIC ELMIRON Date: 06/12/01 Route: GAVAGE Time: 09:26:59 __________________________________________________________________________________________________________________________________ | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| | DAY ON TEST | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| | | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 8| 8| 8| 8| 8| 8| 8| 8| 9| 9| | __________________________________________|__________________________________________________________________________| T (*) | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| O | FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| T | ANIMAL ID | 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| A | 42 MG/KG | 0| 0| 0| 1| 1| 1| 2| 2| 3| 3| 3| 3| 3| 4| 4| 0| 0| 1| 2| 3| 4| 4| 5| 2| 3| L | | 1| 7| 8| 0| 1| 5| 6| 9| 5| 6| 7| 8| 9| 1| 4| 3| 5| 7| 1| 1| 5| 7| 0| 2| 3| | _____________________________________________________________________________________________________________________|____________| INTEGUMENTARY SYSTEM - cont | | | | | | |__________________________________________________________________________|____________| Skin | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Keratoacanthoma | | 3 | Squamous Cell Carcinoma | X | 1 | Sebaceous Gland, Adenoma | X | 1 | Sebaceous Gland, Carcinoma | | 1 | Subcutaneous Tissue, Fibroma | X X | 3 | Subcutaneous Tissue, Fibrosarcoma | X | 1 | _____________________________________________________________________________________________________________________| | MUSCULOSKELETAL SYSTEM | | | |__________________________________________________________________________|____________| Bone | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Skeletal Muscle | | 1 | Histiocytic Sarcoma | | 1 | _____________________________________________________________________________________________________________________| | NERVOUS SYSTEM | | | |__________________________________________________________________________|____________| Brain | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | _____________________________________________________________________________________________________________________| | RESPIRATORY SYSTEM | | | |__________________________________________________________________________|____________| Lung | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Alveolar/Bronchiolar Adenoma | | 1 | Histiocytic Sarcoma | | 1 | |__________________________________________________________________________|____________| Nose | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Trachea | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Schwannoma Malignant, Metastatic, | | | Salivary Glands | | 1 | _____________________________________________________________________________________________________________________| | SPECIAL SENSES SYSTEM | | | None | | | _____________________________________________________________________________________________________________________|____________| * : Total animals with tissue examined microscopically; total animals with tumor + : Tissue examined microscopically M : Missing tissue X : Lesion present A : Autolysis precludes evaluation I : Insufficient tissue BLANK : Not examined microscopically Page 61 NTP Experiment-Test: 88122-06 NEOPLASMS BY INDIVIDUAL ANIMAL (SYSTEMIC LESIONS ABRIDGED) Report: PEIRPT17 Study Type: CHRONIC ELMIRON Date: 06/12/01 Route: GAVAGE Time: 09:26:59 __________________________________________________________________________________________________________________________________ | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| | DAY ON TEST | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| | | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 8| 8| 8| 8| 8| 8| 8| 8| 9| 9| | __________________________________________|__________________________________________________________________________| T (*) | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| O | FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| T | ANIMAL ID | 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| A | 42 MG/KG | 0| 0| 0| 1| 1| 1| 2| 2| 3| 3| 3| 3| 3| 4| 4| 0| 0| 1| 2| 3| 4| 4| 5| 2| 3| L | | 1| 7| 8| 0| 1| 5| 6| 9| 5| 6| 7| 8| 9| 1| 4| 3| 5| 7| 1| 1| 5| 7| 0| 2| 3| | _____________________________________________________________________________________________________________________|____________| URINARY SYSTEM | | | |__________________________________________________________________________|____________| Kidney | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Urinary Bladder | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | __________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS | | | __________________________________________________________________________|____________| Multiple Organs | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Histiocytic Sarcoma | | 1 | Leukemia Mononuclear | X X X X | 12 | Mesothelioma Malignant | X X | 2 | __________________________________________________________________________________________________________________________________ * : Total animals with tissue examined microscopically; total animals with tumor + : Tissue examined microscopically M : Missing tissue X : Lesion present A : Autolysis precludes evaluation I : Insufficient tissue BLANK : Not examined microscopically Page 62 NTP Experiment-Test: 88122-06 NEOPLASMS BY INDIVIDUAL ANIMAL (SYSTEMIC LESIONS ABRIDGED) Report: PEIRPT17 Study Type: CHRONIC ELMIRON Date: 06/12/01 Route: GAVAGE Time: 09:26:59 _____________________________________________________________________________________________________________________ | 1| 1| 2| 2| 3| 4| 4| 4| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 7| 7| DAY ON TEST | 2| 6| 3| 6| 5| 3| 5| 8| 0| 2| 2| 4| 6| 6| 6| 7| 8| 9| 0| 0| 0| 2| 2| 2| 2| | 0| 1| 7| 1| 2| 3| 6| 4| 4| 2| 9| 0| 0| 1| 9| 9| 9| 1| 7| 8| 9| 0| 7| 7| 7| __________________________________________|__________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 126 | 7| 7| 8| 8| 5| 6| 9| 8| 9| 5| 5| 6| 9| 7| 6| 8| 7| 5| 5| 7| 7| 7| 5| 5| 6| MG/KG | 1| 5| 6| 5| 3| 4| 5| 0| 8| 2| 1| 2| 7| 8| 9| 4| 0| 7| 9| 4| 2| 6| 4| 8| 1| __________________________________________|__________________________________________________________________________| ALIMENTARY SYSTEM | | |__________________________________________________________________________| Esophagus | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Intestine Large, Colon | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Intestine Large, Rectum | + + + + A + + + + + A + A + A + + A + + + + + + +| |__________________________________________________________________________| Intestine Large, Cecum | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Intestine Small, Duodenum | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Intestine Small, Jejunum | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Intestine Small, Ileum | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Liver | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Mesentery | + + + + + + | |__________________________________________________________________________| Pancreas | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Salivary Glands | + + + + + + + + + + + + + + + + + + + + + + + + +| Schwannoma Malignant | X | |__________________________________________________________________________| Stomach, Forestomach | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Stomach, Glandular | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| CARDIOVASCULAR SYSTEM | | |__________________________________________________________________________| Blood Vessel | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Heart | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| ENDOCRINE SYSTEM | | |__________________________________________________________________________| Adrenal Cortex | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________|__________________________________________________________________________| Page 63 NTP Experiment-Test: 88122-06 NEOPLASMS BY INDIVIDUAL ANIMAL (SYSTEMIC LESIONS ABRIDGED) Report: PEIRPT17 Study Type: CHRONIC ELMIRON Date: 06/12/01 Route: GAVAGE Time: 09:26:59 _____________________________________________________________________________________________________________________ | 1| 1| 2| 2| 3| 4| 4| 4| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 7| 7| DAY ON TEST | 2| 6| 3| 6| 5| 3| 5| 8| 0| 2| 2| 4| 6| 6| 6| 7| 8| 9| 0| 0| 0| 2| 2| 2| 2| | 0| 1| 7| 1| 2| 3| 6| 4| 4| 2| 9| 0| 0| 1| 9| 9| 9| 1| 7| 8| 9| 0| 7| 7| 7| __________________________________________|__________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 126 | 7| 7| 8| 8| 5| 6| 9| 8| 9| 5| 5| 6| 9| 7| 6| 8| 7| 5| 5| 7| 7| 7| 5| 5| 6| MG/KG | 1| 5| 6| 5| 3| 4| 5| 0| 8| 2| 1| 2| 7| 8| 9| 4| 0| 7| 9| 4| 2| 6| 4| 8| 1| __________________________________________|__________________________________________________________________________| ENDOCRINE SYSTEM - cont | | | | |__________________________________________________________________________| Adrenal Medulla | + + + + + + + + + + + + + + + + + + + + + + + + +| Pheochromocytoma Malignant | | Pheochromocytoma Benign | X X| |__________________________________________________________________________| Islets, Pancreatic | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Parathyroid Gland | + + + + + + + + + + + + + M + + + + + + + + + + +| |__________________________________________________________________________| Pituitary Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| Pars Distalis, Adenoma | X X X X X X| |__________________________________________________________________________| Thyroid Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| C-Cell, Adenoma | X X X| C-Cell, Adenoma, Multiple | | C-Cell, Carcinoma | | Follicle, Adenoma | X | Follicle, Carcinoma | | _____________________________________________________________________________________________________________________| GENERAL BODY SYSTEM | | None | | _____________________________________________________________________________________________________________________| GENITAL SYSTEM | | |__________________________________________________________________________| Coagulating Gland | | |__________________________________________________________________________| Epididymis | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Preputial Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| Adenoma | X | |__________________________________________________________________________| Prostate | + + + + + + + + + + + + + + + + M + + + + + + + +| |__________________________________________________________________________| Seminal Vesicle | + + + + + + + + + + + + + + + + M + + + + + + + +| |__________________________________________________________________________| Testes | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________|__________________________________________________________________________| Page 64 NTP Experiment-Test: 88122-06 NEOPLASMS BY INDIVIDUAL ANIMAL (SYSTEMIC LESIONS ABRIDGED) Report: PEIRPT17 Study Type: CHRONIC ELMIRON Date: 06/12/01 Route: GAVAGE Time: 09:26:59 _____________________________________________________________________________________________________________________ | 1| 1| 2| 2| 3| 4| 4| 4| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 7| 7| DAY ON TEST | 2| 6| 3| 6| 5| 3| 5| 8| 0| 2| 2| 4| 6| 6| 6| 7| 8| 9| 0| 0| 0| 2| 2| 2| 2| | 0| 1| 7| 1| 2| 3| 6| 4| 4| 2| 9| 0| 0| 1| 9| 9| 9| 1| 7| 8| 9| 0| 7| 7| 7| __________________________________________|__________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 126 | 7| 7| 8| 8| 5| 6| 9| 8| 9| 5| 5| 6| 9| 7| 6| 8| 7| 5| 5| 7| 7| 7| 5| 5| 6| MG/KG | 1| 5| 6| 5| 3| 4| 5| 0| 8| 2| 1| 2| 7| 8| 9| 4| 0| 7| 9| 4| 2| 6| 4| 8| 1| __________________________________________|__________________________________________________________________________| GENITAL SYSTEM - cont | | | | Bilateral, Interstitial Cell, Adenoma| X X X X X X X X X X X X X X X| Interstitial Cell, Adenoma | X X | _____________________________________________________________________________________________________________________| HEMATOPOIETIC SYSTEM | | |__________________________________________________________________________| Bone Marrow | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Lymph Node | + + + + + | Deep Cervical, Carcinoma, Metastatic,| | Thyroid Gland | | |__________________________________________________________________________| Lymph Node, Mandibular | M M M M M M M M M M M M M M M M M M M M + M M M M| |__________________________________________________________________________| Lymph Node, Mesenteric | + + + + + + + + + + + + + + + + + A + + + + + + +| |__________________________________________________________________________| Spleen | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Thymus | + + + + + + + M + + + + + + + + M + + M M M + + +| _____________________________________________________________________________________________________________________| INTEGUMENTARY SYSTEM | | |__________________________________________________________________________| Mammary Gland | + + + + M + + + + + + M + + + + + + + + + + + + +| Fibroadenoma | X | |__________________________________________________________________________| Skin | + + + + + + + + + + + + + + + + + + + + + + + + +| Keratoacanthoma | X | Sebaceous Gland, Adenoma | X X | Sebaceous Gland, Carcinoma | | Subcutaneous Tissue, Fibroma | | Subcutaneous Tissue, Fibrosarcoma | X | _____________________________________________________________________________________________________________________| MUSCULOSKELETAL SYSTEM | | |__________________________________________________________________________| Bone | + + + + + + + + + + + + + + + + + + + + + + + + +| Osteosarcoma | X | |__________________________________________________________________________| __________________________________________|__________________________________________________________________________| Page 65 NTP Experiment-Test: 88122-06 NEOPLASMS BY INDIVIDUAL ANIMAL (SYSTEMIC LESIONS ABRIDGED) Report: PEIRPT17 Study Type: CHRONIC ELMIRON Date: 06/12/01 Route: GAVAGE Time: 09:26:59 _____________________________________________________________________________________________________________________ | 1| 1| 2| 2| 3| 4| 4| 4| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 7| 7| DAY ON TEST | 2| 6| 3| 6| 5| 3| 5| 8| 0| 2| 2| 4| 6| 6| 6| 7| 8| 9| 0| 0| 0| 2| 2| 2| 2| | 0| 1| 7| 1| 2| 3| 6| 4| 4| 2| 9| 0| 0| 1| 9| 9| 9| 1| 7| 8| 9| 0| 7| 7| 7| __________________________________________|__________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 126 | 7| 7| 8| 8| 5| 6| 9| 8| 9| 5| 5| 6| 9| 7| 6| 8| 7| 5| 5| 7| 7| 7| 5| 5| 6| MG/KG | 1| 5| 6| 5| 3| 4| 5| 0| 8| 2| 1| 2| 7| 8| 9| 4| 0| 7| 9| 4| 2| 6| 4| 8| 1| __________________________________________|__________________________________________________________________________| MUSCULOSKELETAL SYSTEM - cont | | | | Skeletal Muscle | + + | _____________________________________________________________________________________________________________________| NERVOUS SYSTEM | | |__________________________________________________________________________| Brain | + + + + + + + + + + + + + + + + + + + + + + + + +| Astrocytoma Malignant | X | _____________________________________________________________________________________________________________________| RESPIRATORY SYSTEM | | |__________________________________________________________________________| Larynx | + | |__________________________________________________________________________| Lung | + + + + + + + + + + + + + + + + + + + + + + + + +| Alveolar/Bronchiolar Adenoma | X | Alveolar/Bronchiolar Carcinoma | | Carcinoma, Metastatic, Thyroid Gland | | |__________________________________________________________________________| Nose | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Trachea | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| SPECIAL SENSES SYSTEM | | |__________________________________________________________________________| Eye | | _____________________________________________________________________________________________________________________| URINARY SYSTEM | | |__________________________________________________________________________| Kidney | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Urethra | | |__________________________________________________________________________| Urinary Bladder | + + + + + + + + + + + + + + + + M + + + + + + + +| __________________________________________|__________________________________________________________________________| SYSTEMIC LESIONS | | __________________________________________________________________________| Multiple Organs | + + + + + + + + + + + + + + + + + + + + + + + + +| Leukemia Mononuclear | X X X X X X X X X | Mesothelioma Malignant | X X X| __________________________________________|__________________________________________________________________________| Page 66 NTP Experiment-Test: 88122-06 NEOPLASMS BY INDIVIDUAL ANIMAL (SYSTEMIC LESIONS ABRIDGED) Report: PEIRPT17 Study Type: CHRONIC ELMIRON Date: 06/12/01 Route: GAVAGE Time: 09:26:59 __________________________________________________________________________________________________________________________________ | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| | DAY ON TEST | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| | | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 9| 9| 9| 9| | __________________________________________|__________________________________________________________________________| T (*) | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| O | FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| T | ANIMAL ID | 1| 1| 1| 1| 1| 1| 1| 1| 1| 2| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| A | 126 | 6| 6| 8| 8| 9| 9| 9| 9| 9| 0| 5| 5| 6| 6| 6| 7| 7| 8| 8| 8| 9| 6| 7| 8| 9| L | MG/KG | 3| 8| 1| 7| 1| 2| 3| 6| 9| 0| 5| 6| 5| 6| 7| 3| 7| 2| 3| 8| 4| 0| 9| 9| 0| | _____________________________________________________________________________________________________________________|____________| ALIMENTARY SYSTEM | | | |__________________________________________________________________________|____________| Esophagus | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Intestine Large, Colon | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Intestine Large, Rectum | + + + + + + + + + + + + + + + + + + + + + + + + +| 45 | |__________________________________________________________________________|____________| Intestine Large, Cecum | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Intestine Small, Duodenum | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Intestine Small, Jejunum | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Intestine Small, Ileum | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Liver | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Mesentery | + + + + + + + | 13 | |__________________________________________________________________________|____________| Pancreas | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Salivary Glands | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Schwannoma Malignant | | 1 | |__________________________________________________________________________|____________| Stomach, Forestomach | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Stomach, Glandular | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | _____________________________________________________________________________________________________________________| | CARDIOVASCULAR SYSTEM | | | |__________________________________________________________________________|____________| Blood Vessel | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Heart | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | _____________________________________________________________________________________________________________________|____________| * : Total animals with tissue examined microscopically; total animals with tumor + : Tissue examined microscopically M : Missing tissue X : Lesion present A : Autolysis precludes evaluation I : Insufficient tissue BLANK : Not examined microscopically Page 67 NTP Experiment-Test: 88122-06 NEOPLASMS BY INDIVIDUAL ANIMAL (SYSTEMIC LESIONS ABRIDGED) Report: PEIRPT17 Study Type: CHRONIC ELMIRON Date: 06/12/01 Route: GAVAGE Time: 09:26:59 __________________________________________________________________________________________________________________________________ | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| | DAY ON TEST | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| | | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 9| 9| 9| 9| | __________________________________________|__________________________________________________________________________| T (*) | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| O | FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| T | ANIMAL ID | 1| 1| 1| 1| 1| 1| 1| 1| 1| 2| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| A | 126 | 6| 6| 8| 8| 9| 9| 9| 9| 9| 0| 5| 5| 6| 6| 6| 7| 7| 8| 8| 8| 9| 6| 7| 8| 9| L | MG/KG | 3| 8| 1| 7| 1| 2| 3| 6| 9| 0| 5| 6| 5| 6| 7| 3| 7| 2| 3| 8| 4| 0| 9| 9| 0| | _____________________________________________________________________________________________________________________|____________| CARDIOVASCULAR SYSTEM - cont | | | | | | _____________________________________________________________________________________________________________________| | ENDOCRINE SYSTEM | | | |__________________________________________________________________________|____________| Adrenal Cortex | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Adrenal Medulla | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Pheochromocytoma Malignant | X | 1 | Pheochromocytoma Benign | X X X X X X | 8 | |__________________________________________________________________________|____________| Islets, Pancreatic | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Parathyroid Gland | + + + + + + + + + + + + + + + + M + + + + + + M +| 47 | |__________________________________________________________________________|____________| Pituitary Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Pars Distalis, Adenoma | X X X X X X X | 13 | |__________________________________________________________________________|____________| Thyroid Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | C-Cell, Adenoma | X X X | 6 | C-Cell, Adenoma, Multiple | X | 1 | C-Cell, Carcinoma | X | 1 | Follicle, Adenoma | X X | 3 | Follicle, Carcinoma | X | 1 | _____________________________________________________________________________________________________________________| | GENERAL BODY SYSTEM | | | None | | | _____________________________________________________________________________________________________________________| | GENITAL SYSTEM | | | |__________________________________________________________________________|____________| Coagulating Gland | + | 1 | |__________________________________________________________________________|____________| Epididymis | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| _____________________________________________________________________________________________________________________|____________| * : Total animals with tissue examined microscopically; total animals with tumor + : Tissue examined microscopically M : Missing tissue X : Lesion present A : Autolysis precludes evaluation I : Insufficient tissue BLANK : Not examined microscopically Page 68 NTP Experiment-Test: 88122-06 NEOPLASMS BY INDIVIDUAL ANIMAL (SYSTEMIC LESIONS ABRIDGED) Report: PEIRPT17 Study Type: CHRONIC ELMIRON Date: 06/12/01 Route: GAVAGE Time: 09:26:59 __________________________________________________________________________________________________________________________________ | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| | DAY ON TEST | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| | | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 9| 9| 9| 9| | __________________________________________|__________________________________________________________________________| T (*) | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| O | FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| T | ANIMAL ID | 1| 1| 1| 1| 1| 1| 1| 1| 1| 2| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| A | 126 | 6| 6| 8| 8| 9| 9| 9| 9| 9| 0| 5| 5| 6| 6| 6| 7| 7| 8| 8| 8| 9| 6| 7| 8| 9| L | MG/KG | 3| 8| 1| 7| 1| 2| 3| 6| 9| 0| 5| 6| 5| 6| 7| 3| 7| 2| 3| 8| 4| 0| 9| 9| 0| | _____________________________________________________________________________________________________________________|____________| GENITAL SYSTEM - cont | | | | | | Preputial Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Adenoma | X | 2 | |__________________________________________________________________________|____________| Prostate | + + + + + + + + + + + + + + + + + + + + + + + + +| 49 | |__________________________________________________________________________|____________| Seminal Vesicle | + + + + + + + + + + + + + + + + + + + + + + + + +| 49 | |__________________________________________________________________________|____________| Testes | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Bilateral, Interstitial Cell, Adenoma| X X X X X X X X X X X X X X X X X X X X| 35 | Interstitial Cell, Adenoma | X X X | 5 | _____________________________________________________________________________________________________________________| | HEMATOPOIETIC SYSTEM | | | |__________________________________________________________________________|____________| Bone Marrow | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Lymph Node | + + + + + + + +| 13 | Deep Cervical, Carcinoma, Metastatic,| | | Thyroid Gland | X | 1 | |__________________________________________________________________________|____________| Lymph Node, Mandibular | M M M M M M M M M M M M + M M M M M M M M M M M M| 2 | |__________________________________________________________________________|____________| Lymph Node, Mesenteric | + + + + + + + + + + + + + + + + + + + + + + + + +| 49 | |__________________________________________________________________________|____________| Spleen | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Thymus | + + + + + + + + + + + + + + + M M + + + + + + + +| 43 | _____________________________________________________________________________________________________________________| | INTEGUMENTARY SYSTEM | | | |__________________________________________________________________________|____________| Mammary Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| 48 | Fibroadenoma | X X X X| 5 | |__________________________________________________________________________|____________| _____________________________________________________________________________________________________________________|____________| * : Total animals with tissue examined microscopically; total animals with tumor + : Tissue examined microscopically M : Missing tissue X : Lesion present A : Autolysis precludes evaluation I : Insufficient tissue BLANK : Not examined microscopically Page 69 NTP Experiment-Test: 88122-06 NEOPLASMS BY INDIVIDUAL ANIMAL (SYSTEMIC LESIONS ABRIDGED) Report: PEIRPT17 Study Type: CHRONIC ELMIRON Date: 06/12/01 Route: GAVAGE Time: 09:26:59 __________________________________________________________________________________________________________________________________ | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| | DAY ON TEST | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| | | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 9| 9| 9| 9| | __________________________________________|__________________________________________________________________________| T (*) | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| O | FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| T | ANIMAL ID | 1| 1| 1| 1| 1| 1| 1| 1| 1| 2| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| A | 126 | 6| 6| 8| 8| 9| 9| 9| 9| 9| 0| 5| 5| 6| 6| 6| 7| 7| 8| 8| 8| 9| 6| 7| 8| 9| L | MG/KG | 3| 8| 1| 7| 1| 2| 3| 6| 9| 0| 5| 6| 5| 6| 7| 3| 7| 2| 3| 8| 4| 0| 9| 9| 0| | _____________________________________________________________________________________________________________________|____________| INTEGUMENTARY SYSTEM - cont | | | | | | Skin | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Keratoacanthoma | | 1 | Sebaceous Gland, Adenoma | | 2 | Sebaceous Gland, Carcinoma | X | 1 | Subcutaneous Tissue, Fibroma | X | 1 | Subcutaneous Tissue, Fibrosarcoma | | 1 | _____________________________________________________________________________________________________________________| | MUSCULOSKELETAL SYSTEM | | | |__________________________________________________________________________|____________| Bone | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Osteosarcoma | | 1 | |__________________________________________________________________________|____________| Skeletal Muscle | | 2 | _____________________________________________________________________________________________________________________| | NERVOUS SYSTEM | | | |__________________________________________________________________________|____________| Brain | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Astrocytoma Malignant | | 1 | _____________________________________________________________________________________________________________________| | RESPIRATORY SYSTEM | | | |__________________________________________________________________________|____________| Larynx | | 1 | |__________________________________________________________________________|____________| Lung | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Alveolar/Bronchiolar Adenoma | X | 2 | Alveolar/Bronchiolar Carcinoma | X| 1 | Carcinoma, Metastatic, Thyroid Gland | X | 1 | |__________________________________________________________________________|____________| Nose | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Trachea | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | _____________________________________________________________________________________________________________________| | * : Total animals with tissue examined microscopically; total animals with tumor + : Tissue examined microscopically M : Missing tissue X : Lesion present A : Autolysis precludes evaluation I : Insufficient tissue BLANK : Not examined microscopically Page 70 NTP Experiment-Test: 88122-06 NEOPLASMS BY INDIVIDUAL ANIMAL (SYSTEMIC LESIONS ABRIDGED) Report: PEIRPT17 Study Type: CHRONIC ELMIRON Date: 06/12/01 Route: GAVAGE Time: 09:26:59 __________________________________________________________________________________________________________________________________ | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| | DAY ON TEST | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| | | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 9| 9| 9| 9| | __________________________________________|__________________________________________________________________________| T (*) | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| O | FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| T | ANIMAL ID | 1| 1| 1| 1| 1| 1| 1| 1| 1| 2| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| A | 126 | 6| 6| 8| 8| 9| 9| 9| 9| 9| 0| 5| 5| 6| 6| 6| 7| 7| 8| 8| 8| 9| 6| 7| 8| 9| L | MG/KG | 3| 8| 1| 7| 1| 2| 3| 6| 9| 0| 5| 6| 5| 6| 7| 3| 7| 2| 3| 8| 4| 0| 9| 9| 0| | _____________________________________________________________________________________________________________________|____________| SPECIAL SENSES SYSTEM | | | |__________________________________________________________________________|____________| Eye | + | 1 | _____________________________________________________________________________________________________________________| | URINARY SYSTEM | | | |__________________________________________________________________________|____________| Kidney | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Urethra | + | 1 | |__________________________________________________________________________|____________| Urinary Bladder | + + + + + + + + + + + + + + + + + + + + + + + + +| 49 | __________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS | | | __________________________________________________________________________|____________| Multiple Organs | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Leukemia Mononuclear | X X X X X X X | 16 | Mesothelioma Malignant | X | 4 | __________________________________________________________________________________________________________________________________ * : Total animals with tissue examined microscopically; total animals with tumor + : Tissue examined microscopically M : Missing tissue X : Lesion present A : Autolysis precludes evaluation I : Insufficient tissue BLANK : Not examined microscopically Page 71 ------------------------------------------------------------ ---------- END OF REPORT ---------- ------------------------------------------------------------