TDMS Study 88122-07 Pathology Tables
NTP Experiment-Test: 88122-07 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC ELMIRON Date: 04/23/01 Route: GAVAGE Time: 15:23:02 final#1/Mice Facility: Battelle Columbus Laboratory Chemical CAS #: 37319-17-8 Lock Date: 04/14/00 Cage Range: All Reasons For Removal: All Removal Date Range: All Treatment Groups: Include All Page 1 NTP Experiment-Test: 88122-07 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC ELMIRON Date: 04/23/01 Route: GAVAGE Time: 15:23:02 _____________________________________________________________________________________________________________________ | 7| 6| 7| 7| 7| 4| 7| 7| 7| 7| 7| 5| 6| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| DAY ON TEST | 2| 8| 3| 2| 3| 5| 2| 2| 2| 2| 3| 3| 6| 3| 3| 2| 3| 2| 3| 2| 3| 3| 2| 3| 3| | 9| 5| 0| 9| 0| 6| 9| 9| 9| 9| 0| 6| 7| 0| 0| 9| 0| 9| 0| 9| 0| 0| 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| 0| 0| B6C3F1 MICE 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 | 0| 0| 0| 0| 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 2| | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| __________________________________________|__________________________________________________________________________| ALIMENTARY SYSTEM | | |__________________________________________________________________________| Esophagus | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Gallbladder | + A + + I + + + + + + A A + + + + + + + + + + + +| Degeneration, Hyaline | | |__________________________________________________________________________| Intestine Large, Colon | + A + + + + + + + + + A A + + + + + + + + + + + +| |__________________________________________________________________________| Intestine Large, Rectum | + A + + + + + + + + + A A + + + + + + + + + + + +| Inflammation, Acute | 1 | |__________________________________________________________________________| Intestine Large, Cecum | + A + + + + + + + + + A A + + + + + + + + + + + +| |__________________________________________________________________________| Intestine Small, Duodenum | + A + + + + + + + + + A A + + + I + + + + + + + +| |__________________________________________________________________________| Intestine Small, Jejunum | + + + + + + + + + + + A A + + + + + + + + + + + +| Hyperplasia, Lymphoid | 3 | Inflammation, Acute | 4 | |__________________________________________________________________________| Intestine Small, Ileum | + A + + + + + + + + + A A + + + + + + + + + + + +| |__________________________________________________________________________| Liver | + + + + + + + + + + + + + + + + + + + + + + + + +| Angiectasis | 3 | Basophilic Focus | X X X X | Cyst | | Eosinophilic Focus | X X X X X| Fatty Change | | Hematopoietic Cell Proliferation | | Infarct | | Inflammation, Chronic | 1 1 1 1 1 1 1 1 2 1 1 1 1 1 1 1 1 1 1| Mineralization | | |__________________________________________________________________________| Mesentery | + + + + + + + + + + + + + | Inflammation, Suppurative | | Artery, Inflammation, Chronic Active | 3 | Fat, Necrosis | 3 2 2 2 3 2 2 2 2 2 2 2 | |__________________________________________________________________________| Pancreas | + + + + + + + + + + + A + + + + + + + + + + + + +| __________________________________________|__________________________________________________________________________| Page 2 NTP Experiment-Test: 88122-07 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC ELMIRON Date: 04/23/01 Route: GAVAGE Time: 15:23:02 _____________________________________________________________________________________________________________________ | 7| 6| 7| 7| 7| 4| 7| 7| 7| 7| 7| 5| 6| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| DAY ON TEST | 2| 8| 3| 2| 3| 5| 2| 2| 2| 2| 3| 3| 6| 3| 3| 2| 3| 2| 3| 2| 3| 3| 2| 3| 3| | 9| 5| 0| 9| 0| 6| 9| 9| 9| 9| 0| 6| 7| 0| 0| 9| 0| 9| 0| 9| 0| 0| 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| 0| 0| B6C3F1 MICE 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 | 0| 0| 0| 0| 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 2| | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| __________________________________________|__________________________________________________________________________| ALIMENTARY SYSTEM - cont | | Atrophy | | Inflammation, Acute | | Artery, Inflammation | 3 | |__________________________________________________________________________| Salivary Glands | + + + + + + + + + + + + + + + + + + + + + + + + +| Basophilic Focus | | |__________________________________________________________________________| Stomach, Forestomach | + + + + + + + + + + + A + + + + + + + + + + + + +| Hyperplasia, Squamous | | Ulcer | | Artery, Inflammation, Chronic Active | 3 | |__________________________________________________________________________| Stomach, Glandular | + + + + + + + + + + + A + + + + + + + + + + + + +| Mineralization | | Artery, Inflammation, Chronic Active | 2 | _____________________________________________________________________________________________________________________| CARDIOVASCULAR SYSTEM | | |__________________________________________________________________________| Blood Vessel | + | Aorta, Mineralization | | |__________________________________________________________________________| Heart | + + + + + + + + + + + + + + + + + + + + + + + + +| Inflammation, Chronic Active | 3 | Mineralization | | _____________________________________________________________________________________________________________________| ENDOCRINE SYSTEM | | |__________________________________________________________________________| Adrenal Cortex | + + + + + + + + + + + A + + + + + + + + + + + + +| Hematopoietic Cell Proliferation | | Hyperplasia | 1 1 | Hypertrophy | 1 | |__________________________________________________________________________| Adrenal Medulla | + + + + + + + + + + + A + + + + + + + + + + + + +| |__________________________________________________________________________| Islets, Pancreatic | + + + + + + + + + + + A + + + + + + + + + + + + +| |__________________________________________________________________________| Parathyroid Gland | + M M + + + + M + + + M + M + + + + + M + + + + +| |__________________________________________________________________________| __________________________________________|__________________________________________________________________________| Page 3 NTP Experiment-Test: 88122-07 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC ELMIRON Date: 04/23/01 Route: GAVAGE Time: 15:23:02 _____________________________________________________________________________________________________________________ | 7| 6| 7| 7| 7| 4| 7| 7| 7| 7| 7| 5| 6| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| DAY ON TEST | 2| 8| 3| 2| 3| 5| 2| 2| 2| 2| 3| 3| 6| 3| 3| 2| 3| 2| 3| 2| 3| 3| 2| 3| 3| | 9| 5| 0| 9| 0| 6| 9| 9| 9| 9| 0| 6| 7| 0| 0| 9| 0| 9| 0| 9| 0| 0| 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| 0| 0| B6C3F1 MICE 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 | 0| 0| 0| 0| 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 2| | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| __________________________________________|__________________________________________________________________________| ENDOCRINE SYSTEM - cont | | Pituitary Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| Hyperplasia | | Pars Distalis, Hyperplasia | 3 1 2 3 2 1 1 2 | Pars Intermedia, Hypertrophy | 2 | |__________________________________________________________________________| Thyroid Gland | + A + + + + + + + + + A + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| GENERAL BODY SYSTEM | | None | | _____________________________________________________________________________________________________________________| GENITAL SYSTEM | | |__________________________________________________________________________| Clitoral Gland | + + + + M M + + + + + M + + + M + + M + + M + + +| Inflammation, Chronic Active | | |__________________________________________________________________________| Ovary | + + + + + + + + + + + + M + + + + + + + + + + + +| Angiectasis | 3 | Cyst | 4 3 2 2 1 2 | |__________________________________________________________________________| Uterus | + + + + + + + + + + + + + + + + + + + + + + + + +| Angiectasis | 3 | Hydrometra | 4 3 4 1 2 3 3 3 2 2 3 3 3| Hyperplasia, Cystic | 3 2 2 1 | Inflammation, Suppurative | | _____________________________________________________________________________________________________________________| HEMATOPOIETIC SYSTEM | | |__________________________________________________________________________| Bone Marrow | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Lymph Node | + + + | |__________________________________________________________________________| Lymph Node, Mandibular | + M + M + + + M M + + + + + + + + + + M + + + + M| Hyperplasia, Lymphoid | 4 | |__________________________________________________________________________| Lymph Node, Mesenteric | + A + + + + + + + + + + A + + + + + + + + + + + +| Hyperplasia, Lymphoid | 4 3 4 | Infiltration Cellular, Plasma Cell | 3 | |__________________________________________________________________________| __________________________________________|__________________________________________________________________________| Page 4 NTP Experiment-Test: 88122-07 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC ELMIRON Date: 04/23/01 Route: GAVAGE Time: 15:23:02 _____________________________________________________________________________________________________________________ | 7| 6| 7| 7| 7| 4| 7| 7| 7| 7| 7| 5| 6| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| DAY ON TEST | 2| 8| 3| 2| 3| 5| 2| 2| 2| 2| 3| 3| 6| 3| 3| 2| 3| 2| 3| 2| 3| 3| 2| 3| 3| | 9| 5| 0| 9| 0| 6| 9| 9| 9| 9| 0| 6| 7| 0| 0| 9| 0| 9| 0| 9| 0| 0| 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| 0| 0| B6C3F1 MICE 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 | 0| 0| 0| 0| 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 2| | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| __________________________________________|__________________________________________________________________________| HEMATOPOIETIC SYSTEM - cont | | Spleen | + + + + + + + + + + + A A + + + + + + + + + + + +| Hematopoietic Cell Proliferation | 3 1 1 1 | Hyperplasia, Lymphoid | 3 | |__________________________________________________________________________| Thymus | M + + + + + + + + + + + + + + + + M + + + + + + M| Hyperplasia, Lymphoid | 3 | _____________________________________________________________________________________________________________________| INTEGUMENTARY SYSTEM | | |__________________________________________________________________________| Mammary Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Skin | + + + + + + + + + + + + + + + + + + + + + + + + +| Artery, Inflammation, Chronic Active | 2 | _____________________________________________________________________________________________________________________| MUSCULOSKELETAL SYSTEM | | |__________________________________________________________________________| Bone | + + + + + + + + + + + + + + + + + + + + + + + + +| Fibrous Osteodystrophy | 1 1 2 1 | |__________________________________________________________________________| Skeletal Muscle | + | Artery, Inflammation, Chronic Active | 2 | _____________________________________________________________________________________________________________________| NERVOUS SYSTEM | | |__________________________________________________________________________| Brain | + + + + + + + + + + + + + + + + + + + + + + + + +| Artery, Inflammation, Chronic Active | 3 | _____________________________________________________________________________________________________________________| RESPIRATORY SYSTEM | | |__________________________________________________________________________| Lung | + + + + + + + + + + + + + + + + + + + + + + + + +| Alveolar Epithelium, Hyperplasia | 1 1 | |__________________________________________________________________________| Nose | + + + + + + + + + + + + + + + + + + + + + + + + +| Inflammation, Suppurative | | |__________________________________________________________________________| Trachea | + A + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| SPECIAL SENSES SYSTEM | | __________________________________________|__________________________________________________________________________| Page 5 NTP Experiment-Test: 88122-07 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC ELMIRON Date: 04/23/01 Route: GAVAGE Time: 15:23:02 _____________________________________________________________________________________________________________________ | 7| 6| 7| 7| 7| 4| 7| 7| 7| 7| 7| 5| 6| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| DAY ON TEST | 2| 8| 3| 2| 3| 5| 2| 2| 2| 2| 3| 3| 6| 3| 3| 2| 3| 2| 3| 2| 3| 3| 2| 3| 3| | 9| 5| 0| 9| 0| 6| 9| 9| 9| 9| 0| 6| 7| 0| 0| 9| 0| 9| 0| 9| 0| 0| 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| 0| 0| B6C3F1 MICE 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 | 0| 0| 0| 0| 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 2| | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| __________________________________________|__________________________________________________________________________| SPECIAL SENSES SYSTEM - cont | | |__________________________________________________________________________| Harderian Gland | + + + + + + + + + + + + + + + + + + + + + + + +| Atrophy | | Hyperplasia | 1 2 | _____________________________________________________________________________________________________________________| URINARY SYSTEM | | |__________________________________________________________________________| Kidney | + + + + + + + + + + + A + + + + + + + + + + + + +| Hydronephrosis | | Mineralization | | Nephropathy | 1 1 1 1 1 1 1 1 2 1 | Artery, Inflammation, Chronic Active | 2 | |__________________________________________________________________________| Urinary Bladder | + A + + + + + + + + + A A + + + + + + + + + + + +| Artery, Inflammation, Chronic Active | 3 | __________________________________________|__________________________________________________________________________ Page 6 NTP Experiment-Test: 88122-07 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC ELMIRON Date: 04/23/01 Route: GAVAGE Time: 15:23:02 __________________________________________________________________________________________________________________________________ | 6| 7| 7| 6| 7| 7| 7| 7| 7| 7| 7| 4| 1| 7| 5| 7| 7| 7| 7| 7| 7| 7| 7| 7| 6| | DAY ON TEST | 6| 2| 2| 4| 0| 2| 2| 2| 3| 1| 3| 1| 8| 3| 8| 3| 2| 2| 3| 2| 3| 3| 3| 2| 3| | | 1| 9| 9| 7| 3| 9| 9| 9| 0| 7| 0| 1| 3| 0| 3| 0| 3| 9| 0| 9| 0| 0| 0| 9| 6| | __________________________________________|__________________________________________________________________________| 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 | B6C3F1 MICE 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 | 2| 2| 2| 2| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 5| L | | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| | _____________________________________________________________________________________________________________________|____________| ALIMENTARY SYSTEM | | | |__________________________________________________________________________|____________| Esophagus | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Gallbladder | + + + + + + + + + M + + A + A + A + M + + I + + A| 39 | Degeneration, Hyaline | 1 | 1 1.0| |__________________________________________________________________________|____________| Intestine Large, Colon | + + + A + + + + + + + + + + + + A + + + + + + + +| 45 | |__________________________________________________________________________|____________| Intestine Large, Rectum | + + + A + + + + + + + + + + + + A + + + + + + + +| 45 | Inflammation, Acute | | 1 1.0| |__________________________________________________________________________|____________| Intestine Large, Cecum | + + + A I + + + + + + + A + A + A + + + + + + + A| 41 | |__________________________________________________________________________|____________| Intestine Small, Duodenum | + + + A + + + + + + + + A + A + A + + + + + + + A| 41 | |__________________________________________________________________________|____________| Intestine Small, Jejunum | + + + A + + + + + + + + A + A + A + + + + + + + A| 43 | Hyperplasia, Lymphoid | | 1 3.0| Inflammation, Acute | | 1 4.0| |__________________________________________________________________________|____________| Intestine Small, Ileum | + + + A + + + + + + + + A + A + A + + + + + + + A| 42 | |__________________________________________________________________________|____________| Liver | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Angiectasis | | 1 3.0| Basophilic Focus | X | 5 | Cyst | 2 | 1 2.0| Eosinophilic Focus | X X X X X | 10 | Fatty Change | 1 1 1 4| 4 1.8| Hematopoietic Cell Proliferation | 2 1 3 | 3 2.0| Infarct | 4 | 1 4.0| Inflammation, Chronic | 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 | 40 1.0| Mineralization | 3 | 1 3.0| |__________________________________________________________________________|____________| Mesentery | + + + + + + + + + + + + + + + + +| 30 | Inflammation, Suppurative | 3 | 1 3.0| _____________________________________________________________________________________________________________________|____________| * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 7 NTP Experiment-Test: 88122-07 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC ELMIRON Date: 04/23/01 Route: GAVAGE Time: 15:23:02 __________________________________________________________________________________________________________________________________ | 6| 7| 7| 6| 7| 7| 7| 7| 7| 7| 7| 4| 1| 7| 5| 7| 7| 7| 7| 7| 7| 7| 7| 7| 6| | DAY ON TEST | 6| 2| 2| 4| 0| 2| 2| 2| 3| 1| 3| 1| 8| 3| 8| 3| 2| 2| 3| 2| 3| 3| 3| 2| 3| | | 1| 9| 9| 7| 3| 9| 9| 9| 0| 7| 0| 1| 3| 0| 3| 0| 3| 9| 0| 9| 0| 0| 0| 9| 6| | __________________________________________|__________________________________________________________________________| 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 | B6C3F1 MICE 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 | 2| 2| 2| 2| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 5| L | | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| | _____________________________________________________________________________________________________________________|____________| ALIMENTARY SYSTEM - cont | | | Artery, Inflammation, Chronic Active | | 1 3.0| Fat, Necrosis | 2 2 4 2 2 2 3 2 3 3 2 2 2 2 2 2 2| 29 2.2| |__________________________________________________________________________|____________| Pancreas | + + + A + + + + + + + + A + + + A + + + + + + + +| 46 | Atrophy | 3 | 1 3.0| Inflammation, Acute | 3 | 1 3.0| Artery, Inflammation | | 1 3.0| |__________________________________________________________________________|____________| Salivary Glands | + + + + + + + + + + + + + + + + + + + + + + + + M| 49 | Basophilic Focus | X | 1 | |__________________________________________________________________________|____________| Stomach, Forestomach | + + + + + + + + + + + + A + + + A + + + + + + + +| 47 | Hyperplasia, Squamous | 1 1 | 2 1.0| Ulcer | 2 3 2| 3 2.3| Artery, Inflammation, Chronic Active | | 1 3.0| |__________________________________________________________________________|____________| Stomach, Glandular | + + + A + + + + + + + + A + + + A + + + + + + + +| 46 | Mineralization | 2| 1 2.0| Artery, Inflammation, Chronic Active | | 1 2.0| _____________________________________________________________________________________________________________________| | CARDIOVASCULAR SYSTEM | | | |__________________________________________________________________________|____________| Blood Vessel | +| 2 | Aorta, Mineralization | 2| 1 2.0| |__________________________________________________________________________|____________| Heart | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Inflammation, Chronic Active | | 1 3.0| Mineralization | 1| 1 1.0| _____________________________________________________________________________________________________________________| | ENDOCRINE SYSTEM | | | |__________________________________________________________________________|____________| Adrenal Cortex | + + + + + + + + + + + + + + + + + + + + + + + + +| 49 | Hematopoietic Cell Proliferation | 3 | 1 3.0| Hyperplasia | 1 1 1 | 5 1.0| _____________________________________________________________________________________________________________________|____________| * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 8 NTP Experiment-Test: 88122-07 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC ELMIRON Date: 04/23/01 Route: GAVAGE Time: 15:23:02 __________________________________________________________________________________________________________________________________ | 6| 7| 7| 6| 7| 7| 7| 7| 7| 7| 7| 4| 1| 7| 5| 7| 7| 7| 7| 7| 7| 7| 7| 7| 6| | DAY ON TEST | 6| 2| 2| 4| 0| 2| 2| 2| 3| 1| 3| 1| 8| 3| 8| 3| 2| 2| 3| 2| 3| 3| 3| 2| 3| | | 1| 9| 9| 7| 3| 9| 9| 9| 0| 7| 0| 1| 3| 0| 3| 0| 3| 9| 0| 9| 0| 0| 0| 9| 6| | __________________________________________|__________________________________________________________________________| 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 | B6C3F1 MICE 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 | 2| 2| 2| 2| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 5| L | | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| | _____________________________________________________________________________________________________________________|____________| ENDOCRINE SYSTEM - cont | | | Hypertrophy | | 1 1.0| |__________________________________________________________________________|____________| Adrenal Medulla | + + + + + + + + + + + + + + + + + + + + + + + + +| 49 | |__________________________________________________________________________|____________| Islets, Pancreatic | + + + A + + + + + + + + A + + + A + + + + + + + +| 46 | |__________________________________________________________________________|____________| Parathyroid Gland | M M + + I + + + + + + + M + + + M + + + + + I M +| 37 | |__________________________________________________________________________|____________| Pituitary Gland | + + + + + + + + + + + + + + + + + + + + + M + + M| 48 | Hyperplasia | 2 | 1 2.0| Pars Distalis, Hyperplasia | 3 2 2 | 11 2.0| Pars Intermedia, Hypertrophy | | 1 2.0| |__________________________________________________________________________|____________| Thyroid Gland | + + + + + + + + + + + + A + + + A + + + + + + + +| 46 | _____________________________________________________________________________________________________________________| | GENERAL BODY SYSTEM | | | None | | | _____________________________________________________________________________________________________________________| | GENITAL SYSTEM | | | |__________________________________________________________________________|____________| Clitoral Gland | M + + + + + + + + + + + M I + + + M + + + + + M +| 39 | Inflammation, Chronic Active | 1 | 1 1.0| |__________________________________________________________________________|____________| Ovary | + + + + M + + + + + + + + + + + + + + + I + + + +| 47 | Angiectasis | | 1 3.0| Cyst | 2 1 2 2 | 10 2.1| |__________________________________________________________________________|____________| Uterus | + + + + + + + + + + + + A + + + A + + + + + + + +| 48 | Angiectasis | | 1 3.0| Hydrometra | 4 3 1 3 2 4 2 3 2 2 3 3 2 2 | 27 2.7| Hyperplasia, Cystic | 2 2 2 2| 8 2.0| Inflammation, Suppurative | 2 1 | 2 1.5| _____________________________________________________________________________________________________________________| | HEMATOPOIETIC SYSTEM | | | _____________________________________________________________________________________________________________________|____________| * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 9 NTP Experiment-Test: 88122-07 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC ELMIRON Date: 04/23/01 Route: GAVAGE Time: 15:23:02 __________________________________________________________________________________________________________________________________ | 6| 7| 7| 6| 7| 7| 7| 7| 7| 7| 7| 4| 1| 7| 5| 7| 7| 7| 7| 7| 7| 7| 7| 7| 6| | DAY ON TEST | 6| 2| 2| 4| 0| 2| 2| 2| 3| 1| 3| 1| 8| 3| 8| 3| 2| 2| 3| 2| 3| 3| 3| 2| 3| | | 1| 9| 9| 7| 3| 9| 9| 9| 0| 7| 0| 1| 3| 0| 3| 0| 3| 9| 0| 9| 0| 0| 0| 9| 6| | __________________________________________|__________________________________________________________________________| 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 | B6C3F1 MICE 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 | 2| 2| 2| 2| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 5| L | | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| | _____________________________________________________________________________________________________________________|____________| HEMATOPOIETIC SYSTEM - cont | | | |__________________________________________________________________________|____________| Bone Marrow | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Lymph Node | + + + | 6 | |__________________________________________________________________________|____________| Lymph Node, Mandibular | + M + + M M + + M + M + M + M M + M + M + + + + M| 33 | Hyperplasia, Lymphoid | | 1 4.0| |__________________________________________________________________________|____________| Lymph Node, Mesenteric | + + + + + + + + + + + + M + + + + + + + + + + + +| 47 | Hyperplasia, Lymphoid | | 3 3.7| Infiltration Cellular, Plasma Cell | | 1 3.0| |__________________________________________________________________________|____________| Spleen | + + + + + + + + + + + + A + + + + + + + + + + + +| 47 | Hematopoietic Cell Proliferation | 2 2 4 3 1 4 | 10 2.2| Hyperplasia, Lymphoid | | 1 3.0| |__________________________________________________________________________|____________| Thymus | + + + + M + + + + + + + + M + + A + + + + + + + M| 43 | Hyperplasia, Lymphoid | | 1 3.0| _____________________________________________________________________________________________________________________| | INTEGUMENTARY SYSTEM | | | |__________________________________________________________________________|____________| Mammary Gland | + + + + + + + + + + + + + + + + A + + + + + + + +| 49 | |__________________________________________________________________________|____________| Skin | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Artery, Inflammation, Chronic Active | | 1 2.0| _____________________________________________________________________________________________________________________| | MUSCULOSKELETAL SYSTEM | | | |__________________________________________________________________________|____________| Bone | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Fibrous Osteodystrophy | | 4 1.3| |__________________________________________________________________________|____________| Skeletal Muscle | + | 2 | Artery, Inflammation, Chronic Active | | 1 2.0| _____________________________________________________________________________________________________________________| | * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 10 NTP Experiment-Test: 88122-07 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC ELMIRON Date: 04/23/01 Route: GAVAGE Time: 15:23:02 __________________________________________________________________________________________________________________________________ | 6| 7| 7| 6| 7| 7| 7| 7| 7| 7| 7| 4| 1| 7| 5| 7| 7| 7| 7| 7| 7| 7| 7| 7| 6| | DAY ON TEST | 6| 2| 2| 4| 0| 2| 2| 2| 3| 1| 3| 1| 8| 3| 8| 3| 2| 2| 3| 2| 3| 3| 3| 2| 3| | | 1| 9| 9| 7| 3| 9| 9| 9| 0| 7| 0| 1| 3| 0| 3| 0| 3| 9| 0| 9| 0| 0| 0| 9| 6| | __________________________________________|__________________________________________________________________________| 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 | B6C3F1 MICE 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 | 2| 2| 2| 2| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 5| L | | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| | _____________________________________________________________________________________________________________________|____________| NERVOUS SYSTEM | | | |__________________________________________________________________________|____________| Brain | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Artery, Inflammation, Chronic Active | | 1 3.0| _____________________________________________________________________________________________________________________| | RESPIRATORY SYSTEM | | | |__________________________________________________________________________|____________| Lung | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Alveolar Epithelium, Hyperplasia | 1 3 2 | 5 1.6| |__________________________________________________________________________|____________| Nose | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Inflammation, Suppurative | 1 2 | 2 1.5| |__________________________________________________________________________|____________| Trachea | + + + + + + + + + + + + A + + + A + + + + + + + A| 46 | _____________________________________________________________________________________________________________________| | SPECIAL SENSES SYSTEM | | | |__________________________________________________________________________|____________| Harderian Gland | + + + + + + + + + + + + + + + + + + + + M + + + +| 48 | Atrophy | 1 | 1 1.0| Hyperplasia | 1 | 3 1.3| _____________________________________________________________________________________________________________________| | URINARY SYSTEM | | | |__________________________________________________________________________|____________| Kidney | + + + + + + + + + + + + A + + + + + + + + + + + +| 48 | Hydronephrosis | 4 | 1 4.0| Mineralization | 2 1 1 | 3 1.3| Nephropathy | 3 1 1 1 1 1 1 1 2| 19 1.2| Artery, Inflammation, Chronic Active | | 1 2.0| |__________________________________________________________________________|____________| Urinary Bladder | + + + A + + + + + + + + A + + + A + + + + + + + M| 43 | Artery, Inflammation, Chronic Active | | 1 3.0| __________________________________________________________________________________________________________________________________ * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 11 NTP Experiment-Test: 88122-07 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC ELMIRON Date: 04/23/01 Route: GAVAGE Time: 15:23:02 _____________________________________________________________________________________________________________________ | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 6| 7| 7| 6| 7| 7| 7| 7| 7| DAY ON TEST | 3| 2| 2| 2| 0| 3| 3| 3| 2| 3| 2| 3| 2| 2| 3| 2| 8| 2| 2| 8| 2| 2| 3| 3| 3| | 0| 9| 9| 9| 3| 0| 0| 0| 9| 0| 9| 0| 9| 9| 0| 9| 1| 9| 9| 1| 9| 2| 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| 0| 0| B6C3F1 MICE 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| 56 MG/KG | 5| 5| 5| 5| 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 7| | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| __________________________________________|__________________________________________________________________________| ALIMENTARY SYSTEM | | |__________________________________________________________________________| Esophagus | + + + + + + + + + + + + + + + + + + + + + + + + +| Necrosis | | |__________________________________________________________________________| Gallbladder | + + + + + + + + + + + + + + + + + M M + + A + + +| Cyst | 1 | Degeneration, Hyaline | 3 | |__________________________________________________________________________| Intestine Large, Colon | + + + + + + + + + + + + + + + + + + + + + A + + +| |__________________________________________________________________________| Intestine Large, Rectum | + + + + + + + + + + + + + + + + + + + + + A + + +| Myxomatous Change | 1 | |__________________________________________________________________________| Intestine Large, Cecum | + + + + + + + + + + + + + + + + + + + + + A + + +| |__________________________________________________________________________| Intestine Small, Duodenum | + + + + + + + + + + + + + + + + + + + + + A + + +| |__________________________________________________________________________| Intestine Small, Jejunum | + + + + + + + + + + + + + + + + + + + + + A + + +| Hyperplasia, Lymphoid | | |__________________________________________________________________________| Intestine Small, Ileum | + + + + + + + + + + + + + + + + + + + + + A + + +| |__________________________________________________________________________| Liver | + + + + + + + + + + + + + + + + + + + + + + + + +| Angiectasis | | Basophilic Focus | X X X X X| Clear Cell Focus | X | Cyst | | Eosinophilic Focus | X X X X | Fatty Change | | Hematopoietic Cell Proliferation | 1 2 2 2 | Inflammation, Chronic | 1 1 1 1 1 1 1 2 1 1 1 1 1 3 1 1 1 1 1 1 1 1| Tension Lipidosis | X | Bile Duct, Hyperplasia | | |__________________________________________________________________________| Mesentery | + + + + + + + + + + + + + + + + +| Fat, Necrosis | 2 2 2 3 2 2 2 2 2 2 2 2 1 2 2 1 3| |__________________________________________________________________________| Pancreas | + + + + + + + + + + + + + + + + + + + + + A + + +| __________________________________________|__________________________________________________________________________| Page 12 NTP Experiment-Test: 88122-07 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC ELMIRON Date: 04/23/01 Route: GAVAGE Time: 15:23:02 _____________________________________________________________________________________________________________________ | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 6| 7| 7| 6| 7| 7| 7| 7| 7| DAY ON TEST | 3| 2| 2| 2| 0| 3| 3| 3| 2| 3| 2| 3| 2| 2| 3| 2| 8| 2| 2| 8| 2| 2| 3| 3| 3| | 0| 9| 9| 9| 3| 0| 0| 0| 9| 0| 9| 0| 9| 9| 0| 9| 1| 9| 9| 1| 9| 2| 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| 0| 0| B6C3F1 MICE 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| 56 MG/KG | 5| 5| 5| 5| 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 7| | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| __________________________________________|__________________________________________________________________________| ALIMENTARY SYSTEM - cont | | Basophilic Focus | X | Lipomatosis | 4 | |__________________________________________________________________________| Salivary Glands | + + + + + + + + + + + + + + + + + + + + + M + + +| Basophilic Focus | | |__________________________________________________________________________| Stomach, Forestomach | + + + + + + + + + + + + + + + + + + + + + A + + +| Hyperplasia, Squamous | 1 | Inflammation, Acute | | |__________________________________________________________________________| Stomach, Glandular | + + + + + + + + + + + + + + + + + + + + + A + + +| Hyperplasia | 2 | Necrosis | 2 | _____________________________________________________________________________________________________________________| CARDIOVASCULAR SYSTEM | | |__________________________________________________________________________| Heart | + + + + + + + + + + + + + + + + + + + + + + + + +| Cardiomyopathy | 1 | Inflammation, Chronic Active | | Inflammation, Suppurative | 2 | Mineralization | | _____________________________________________________________________________________________________________________| ENDOCRINE SYSTEM | | |__________________________________________________________________________| Adrenal Cortex | + + + + + + + + + + + + + + + + + + + + + A + + +| Hyperplasia | 2 2 | Hypertrophy | 1 1 1 | |__________________________________________________________________________| Adrenal Medulla | + + + + + + + + + + + + + + + + + + + + + A + + +| |__________________________________________________________________________| Islets, Pancreatic | + + + + + + + + + + + + + + + + + + + + + A + + +| |__________________________________________________________________________| Parathyroid Gland | + + M + M M + + + + + + + M + + + M + + M M + + +| |__________________________________________________________________________| Pituitary Gland | + + + + + + + + + + + + + + + + M + + + + M M + +| Pars Distalis, Hyperplasia | 3 2 2 2 2| |__________________________________________________________________________| Thyroid Gland | + + + + + + + + + + + + + + + + + M + + + M + + +| __________________________________________|__________________________________________________________________________| Page 13 NTP Experiment-Test: 88122-07 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC ELMIRON Date: 04/23/01 Route: GAVAGE Time: 15:23:02 _____________________________________________________________________________________________________________________ | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 6| 7| 7| 6| 7| 7| 7| 7| 7| DAY ON TEST | 3| 2| 2| 2| 0| 3| 3| 3| 2| 3| 2| 3| 2| 2| 3| 2| 8| 2| 2| 8| 2| 2| 3| 3| 3| | 0| 9| 9| 9| 3| 0| 0| 0| 9| 0| 9| 0| 9| 9| 0| 9| 1| 9| 9| 1| 9| 2| 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| 0| 0| B6C3F1 MICE 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| 56 MG/KG | 5| 5| 5| 5| 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 7| | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| __________________________________________|__________________________________________________________________________| ENDOCRINE SYSTEM - cont | | Necrosis | | Follicular Cell, Hyperplasia | 2 | _____________________________________________________________________________________________________________________| GENERAL BODY SYSTEM | | |__________________________________________________________________________| Tissue NOS | + | _____________________________________________________________________________________________________________________| GENITAL SYSTEM | | |__________________________________________________________________________| Clitoral Gland | + + I + + M + + + + + + + + + + + + + + + M + + +| Cyst | 2 | Inflammation, Chronic Active | | |__________________________________________________________________________| Ovary | + + + + + + + + + + + + + + + I + + + + + + + + +| Cyst | 2 3 2 2 2 2 1 1 2 | Thrombosis | | |__________________________________________________________________________| Uterus | + + + + + + + + + + + + + + + + + + + + + A + + +| Angiectasis | | Hydrometra | 3 1 1 2 2 3 3 2 2 1 2| Hyperplasia, Cystic | 2 2 1 4 2 | _____________________________________________________________________________________________________________________| HEMATOPOIETIC SYSTEM | | |__________________________________________________________________________| Bone Marrow | + + + + + + + + + + + + + + + + + + + + + A + + +| |__________________________________________________________________________| Lymph Node | + + +| Bronchial, Hyperplasia, Lymphoid | 4 | Mediastinal, Hyperplasia, Lymphoid | 4 | Renal, Hyperplasia, Lymphoid | 4 | |__________________________________________________________________________| Lymph Node, Mandibular | + M + + M + M + M + M + + + M + + + + + + M + M +| Hyperplasia, Lymphoid | 4 | Infiltration Cellular, Plasma Cell | | |__________________________________________________________________________| Lymph Node, Mesenteric | + + + + + + + + + + + + + + + + + + + + + A + + +| Hyperplasia, Lymphoid | 4 | Infiltration Cellular, Histiocyte | 1 1 1 1 1 1 2 1 1 1 1 | __________________________________________|__________________________________________________________________________| Page 14 NTP Experiment-Test: 88122-07 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC ELMIRON Date: 04/23/01 Route: GAVAGE Time: 15:23:02 _____________________________________________________________________________________________________________________ | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 6| 7| 7| 6| 7| 7| 7| 7| 7| DAY ON TEST | 3| 2| 2| 2| 0| 3| 3| 3| 2| 3| 2| 3| 2| 2| 3| 2| 8| 2| 2| 8| 2| 2| 3| 3| 3| | 0| 9| 9| 9| 3| 0| 0| 0| 9| 0| 9| 0| 9| 9| 0| 9| 1| 9| 9| 1| 9| 2| 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| 0| 0| B6C3F1 MICE 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| 56 MG/KG | 5| 5| 5| 5| 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 7| | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| __________________________________________|__________________________________________________________________________| HEMATOPOIETIC SYSTEM - cont | | |__________________________________________________________________________| Spleen | + + + + + + + + + + + + + + + + + + + + + A + + +| Congestion | 3 | Hematopoietic Cell Proliferation | 4 1 4 1 1 3 4 1| Hyperplasia, Lymphoid | 2 2 3 | Infiltration Cellular, Histiocyte | 1 | |__________________________________________________________________________| Thymus | M M M + + + + + + M + M M + + + + + + M + M + + +| Necrosis | | _____________________________________________________________________________________________________________________| INTEGUMENTARY SYSTEM | | |__________________________________________________________________________| Mammary Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Skin | + + + + + + + + + + + + + + + + + + + + + + + + +| Edema | | Inflammation, Chronic Active | | Subcutaneous Tissue, Necrosis, Fatty | | _____________________________________________________________________________________________________________________| MUSCULOSKELETAL SYSTEM | | |__________________________________________________________________________| Bone | + + + + + + + + + + + + + + + + + + + + + + + + +| Fibrous Osteodystrophy | | _____________________________________________________________________________________________________________________| NERVOUS SYSTEM | | |__________________________________________________________________________| Brain | + + + + + + + + + + + + + + + + + + + + + M + + +| _____________________________________________________________________________________________________________________| RESPIRATORY SYSTEM | | |__________________________________________________________________________| Lung | + + + + + + + + + + + + + + + + + + + + + + + + +| Infiltration Cellular, Lymphocyte | 1 | Inflammation, Chronic Active | 1 | Thrombosis | | Alveolar Epithelium, Hyperplasia | 2 1 | Mediastinum, Inflammation, Acute | | |__________________________________________________________________________| Nose | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________|__________________________________________________________________________| Page 15 NTP Experiment-Test: 88122-07 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC ELMIRON Date: 04/23/01 Route: GAVAGE Time: 15:23:02 _____________________________________________________________________________________________________________________ | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 6| 7| 7| 6| 7| 7| 7| 7| 7| DAY ON TEST | 3| 2| 2| 2| 0| 3| 3| 3| 2| 3| 2| 3| 2| 2| 3| 2| 8| 2| 2| 8| 2| 2| 3| 3| 3| | 0| 9| 9| 9| 3| 0| 0| 0| 9| 0| 9| 0| 9| 9| 0| 9| 1| 9| 9| 1| 9| 2| 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| 0| 0| B6C3F1 MICE 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| 56 MG/KG | 5| 5| 5| 5| 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 7| | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| __________________________________________|__________________________________________________________________________| RESPIRATORY SYSTEM - cont | | Olfactory Epithelium, Atrophy | 1 | Olfactory Epithelium, Metaplasia | 1 3 | |__________________________________________________________________________| Pleura | + | |__________________________________________________________________________| Trachea | + + + + + + + + + + + + + + + + + + + + + A + + +| Metaplasia, Squamous | | _____________________________________________________________________________________________________________________| SPECIAL SENSES SYSTEM | | |__________________________________________________________________________| Harderian Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| Atrophy | 2 | Hyperplasia | 1 3 | _____________________________________________________________________________________________________________________| URINARY SYSTEM | | |__________________________________________________________________________| Kidney | + + + + + + + + + + + + + + + + + + + + + + + + +| Cyst | | Infarct | 2 | Mineralization | 2 | Nephropathy | 1 1 1 1 1 1 1 1 1 | Renal Tubule, Accumulation, Hyaline | | Droplet | 3 | |__________________________________________________________________________| Ureter | | |__________________________________________________________________________| Urethra | | |__________________________________________________________________________| Urinary Bladder | + + + + + + + + + + + + + + + + + + + + + A + + +| __________________________________________|__________________________________________________________________________ Page 16 NTP Experiment-Test: 88122-07 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC ELMIRON Date: 04/23/01 Route: GAVAGE Time: 15:23:02 __________________________________________________________________________________________________________________________________ | 7| 7| 7| 7| 5| 4| 7| 0| 7| 7| 7| 7| 7| 5| 2| 7| 7| 7| 7| 7| 7| 6| 7| 7| 7| | DAY ON TEST | 3| 3| 3| 2| 5| 8| 3| 1| 3| 2| 2| 3| 2| 4| 8| 2| 3| 3| 2| 2| 1| 4| 2| 0| 2| | | 0| 0| 0| 9| 5| 5| 0| 8| 0| 9| 9| 0| 9| 1| 1| 9| 0| 0| 9| 9| 1| 2| 9| 3| 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 | B6C3F1 MICE 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 | 56 MG/KG | 7| 7| 7| 7| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 0| L | | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| | _____________________________________________________________________________________________________________________|____________| ALIMENTARY SYSTEM | | | |__________________________________________________________________________|____________| Esophagus | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Necrosis | 3 | 1 3.0| |__________________________________________________________________________|____________| Gallbladder | + + + + + A A + + + + + + A A + + + + + A A + M +| 40 | Cyst | 1 | 2 1.0| Degeneration, Hyaline | | 1 3.0| |__________________________________________________________________________|____________| Intestine Large, Colon | + + + + + A A + + + + + + A A + + + + + + A + + +| 44 | |__________________________________________________________________________|____________| Intestine Large, Rectum | + + + + + A A + + + + + + + A + + + + + + A + + +| 45 | Myxomatous Change | 1 1| 3 1.0| |__________________________________________________________________________|____________| Intestine Large, Cecum | + + + + + A A + + + + + + A A + + + + + A A + + +| 43 | |__________________________________________________________________________|____________| Intestine Small, Duodenum | + + + + + A A + + + + + + A A + + + + + + A + + +| 44 | |__________________________________________________________________________|____________| Intestine Small, Jejunum | + + + + + A A + + + + + + A A + + + + + + A + + +| 44 | Hyperplasia, Lymphoid | 2 | 1 2.0| |__________________________________________________________________________|____________| Intestine Small, Ileum | + + + + + A A + + + + + + A A + + + + + + A + + +| 44 | |__________________________________________________________________________|____________| Liver | + + + + + A + + + + + + + + + + + + + + + + + + +| 49 | Angiectasis | 3 | 1 3.0| Basophilic Focus | X | 6 | Clear Cell Focus | X X X | 4 | Cyst | 2 | 1 2.0| Eosinophilic Focus | X X | 6 | Fatty Change | 1 1| 2 1.0| Hematopoietic Cell Proliferation | 1 1 1 | 7 1.4| Inflammation, Chronic | 1 1 1 1 1 1 2 1 1 1 1 1 1 2 1| 37 1.1| Tension Lipidosis | X | 2 | Bile Duct, Hyperplasia | 1 | 1 1.0| |__________________________________________________________________________|____________| _____________________________________________________________________________________________________________________|____________| * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 17 NTP Experiment-Test: 88122-07 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC ELMIRON Date: 04/23/01 Route: GAVAGE Time: 15:23:02 __________________________________________________________________________________________________________________________________ | 7| 7| 7| 7| 5| 4| 7| 0| 7| 7| 7| 7| 7| 5| 2| 7| 7| 7| 7| 7| 7| 6| 7| 7| 7| | DAY ON TEST | 3| 3| 3| 2| 5| 8| 3| 1| 3| 2| 2| 3| 2| 4| 8| 2| 3| 3| 2| 2| 1| 4| 2| 0| 2| | | 0| 0| 0| 9| 5| 5| 0| 8| 0| 9| 9| 0| 9| 1| 1| 9| 0| 0| 9| 9| 1| 2| 9| 3| 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 | B6C3F1 MICE 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 | 56 MG/KG | 7| 7| 7| 7| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 0| L | | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| | _____________________________________________________________________________________________________________________|____________| ALIMENTARY SYSTEM - cont | | | Mesentery | + + + + + + + + + + + + + + + + +| 34 | Fat, Necrosis | 2 2 2 1 2 3 2 2 2 2 2 3 3 2 2 2| 33 2.1| |__________________________________________________________________________|____________| Pancreas | + + + + + A A + + + + + + + A + + + + + + A + + +| 45 | Basophilic Focus | X | 2 | Lipomatosis | | 1 4.0| |__________________________________________________________________________|____________| Salivary Glands | + + + + + + + + + + + + + + + + + + + + + + + + +| 49 | Basophilic Focus | X | 1 | |__________________________________________________________________________|____________| Stomach, Forestomach | + + + + + A + + + + + + + + + + + + + + + + + + +| 48 | Hyperplasia, Squamous | 2 | 2 1.5| Inflammation, Acute | 1 | 1 1.0| |__________________________________________________________________________|____________| Stomach, Glandular | + + + + + A A + + + + + + + A + + + + + + A + + +| 45 | Hyperplasia | | 1 2.0| Necrosis | | 1 2.0| _____________________________________________________________________________________________________________________| | CARDIOVASCULAR SYSTEM | | | |__________________________________________________________________________|____________| Heart | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Cardiomyopathy | | 1 1.0| Inflammation, Chronic Active | 1 2 | 2 1.5| Inflammation, Suppurative | | 1 2.0| Mineralization | 1 | 1 1.0| _____________________________________________________________________________________________________________________| | ENDOCRINE SYSTEM | | | |__________________________________________________________________________|____________| Adrenal Cortex | + + + + + + + + + + + + + + + + + + + + + + + + +| 49 | Hyperplasia | 2 | 3 2.0| Hypertrophy | | 3 1.0| |__________________________________________________________________________|____________| Adrenal Medulla | + + + + + + + + + + + + + + + + + + + + + + + + +| 49 | |__________________________________________________________________________|____________| _____________________________________________________________________________________________________________________|____________| * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 18 NTP Experiment-Test: 88122-07 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC ELMIRON Date: 04/23/01 Route: GAVAGE Time: 15:23:02 __________________________________________________________________________________________________________________________________ | 7| 7| 7| 7| 5| 4| 7| 0| 7| 7| 7| 7| 7| 5| 2| 7| 7| 7| 7| 7| 7| 6| 7| 7| 7| | DAY ON TEST | 3| 3| 3| 2| 5| 8| 3| 1| 3| 2| 2| 3| 2| 4| 8| 2| 3| 3| 2| 2| 1| 4| 2| 0| 2| | | 0| 0| 0| 9| 5| 5| 0| 8| 0| 9| 9| 0| 9| 1| 1| 9| 0| 0| 9| 9| 1| 2| 9| 3| 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 | B6C3F1 MICE 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 | 56 MG/KG | 7| 7| 7| 7| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 0| L | | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| | _____________________________________________________________________________________________________________________|____________| ENDOCRINE SYSTEM - cont | | | Islets, Pancreatic | + + + + + A A + + + + + + + A + + + + + + A + + +| 45 | |__________________________________________________________________________|____________| Parathyroid Gland | + M + + + + + M + + + + + + M M + + + + A + + + +| 38 | |__________________________________________________________________________|____________| Pituitary Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| 47 | Pars Distalis, Hyperplasia | 2 2 2 | 8 2.1| |__________________________________________________________________________|____________| Thyroid Gland | + + + + + + + + + + + + + + A + + + + + + + + + +| 47 | Necrosis | 3 | 1 3.0| Follicular Cell, Hyperplasia | | 1 2.0| _____________________________________________________________________________________________________________________| | GENERAL BODY SYSTEM | | | |__________________________________________________________________________|____________| Tissue NOS | | 1 | _____________________________________________________________________________________________________________________| | GENITAL SYSTEM | | | |__________________________________________________________________________|____________| Clitoral Gland | + + + + + + + M + + + + + + + M + M + + + + + + +| 44 | Cyst | | 1 2.0| Inflammation, Chronic Active | 3 | 1 3.0| |__________________________________________________________________________|____________| Ovary | + + + + + + A + + + + + + + + + + + + + + A + + I| 46 | Cyst | 2 2 2 | 12 1.9| Thrombosis | 3 | 1 3.0| |__________________________________________________________________________|____________| Uterus | + + + + + + + + + + + + + + + + + + + + + + + + +| 49 | Angiectasis | 2 | 1 2.0| Hydrometra | 3 2 3 4 1 2 2 4 3 2 | 21 2.3| Hyperplasia, Cystic | 2 3 2 2 | 9 2.2| _____________________________________________________________________________________________________________________| | HEMATOPOIETIC SYSTEM | | | |__________________________________________________________________________|____________| Bone Marrow | + + + + + + + + + + + + + + A + + + + + + + + + +| 48 | |__________________________________________________________________________|____________| _____________________________________________________________________________________________________________________|____________| * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 19 NTP Experiment-Test: 88122-07 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC ELMIRON Date: 04/23/01 Route: GAVAGE Time: 15:23:02 __________________________________________________________________________________________________________________________________ | 7| 7| 7| 7| 5| 4| 7| 0| 7| 7| 7| 7| 7| 5| 2| 7| 7| 7| 7| 7| 7| 6| 7| 7| 7| | DAY ON TEST | 3| 3| 3| 2| 5| 8| 3| 1| 3| 2| 2| 3| 2| 4| 8| 2| 3| 3| 2| 2| 1| 4| 2| 0| 2| | | 0| 0| 0| 9| 5| 5| 0| 8| 0| 9| 9| 0| 9| 1| 1| 9| 0| 0| 9| 9| 1| 2| 9| 3| 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 | B6C3F1 MICE 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 | 56 MG/KG | 7| 7| 7| 7| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 0| L | | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| | _____________________________________________________________________________________________________________________|____________| HEMATOPOIETIC SYSTEM - cont | | | Lymph Node | + + + + + + + | 10 | Bronchial, Hyperplasia, Lymphoid | | 1 4.0| Mediastinal, Hyperplasia, Lymphoid | | 1 4.0| Renal, Hyperplasia, Lymphoid | | 1 4.0| |__________________________________________________________________________|____________| Lymph Node, Mandibular | + + + + + + + + M M + M + + A + + + + + + + + + +| 38 | Hyperplasia, Lymphoid | | 1 4.0| Infiltration Cellular, Plasma Cell | 3 | 1 3.0| |__________________________________________________________________________|____________| Lymph Node, Mesenteric | + + + + + A A + + + + + + M A + + + + + + A + + +| 44 | Hyperplasia, Lymphoid | | 1 4.0| Infiltration Cellular, Histiocyte | 1 1 1 1 2 2 2 1 2 1 1 1| 23 1.2| |__________________________________________________________________________|____________| Spleen | + + + + + + + + + + + + + + + + + + + + + A + + +| 48 | Congestion | | 1 3.0| Hematopoietic Cell Proliferation | 2 3 1 1 1 2 2 1 2 1 1| 19 1.9| Hyperplasia, Lymphoid | | 3 2.3| Infiltration Cellular, Histiocyte | 1 1 | 3 1.0| |__________________________________________________________________________|____________| Thymus | + + + + + + A + + + + + + + + M + + + M + + + + M| 38 | Necrosis | 3 | 1 3.0| _____________________________________________________________________________________________________________________| | INTEGUMENTARY SYSTEM | | | |__________________________________________________________________________|____________| Mammary Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Skin | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Edema | 3 | 1 3.0| Inflammation, Chronic Active | 3 | 1 3.0| Subcutaneous Tissue, Necrosis, Fatty | 2 | 1 2.0| _____________________________________________________________________________________________________________________| | MUSCULOSKELETAL SYSTEM | | | |__________________________________________________________________________|____________| Bone | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | _____________________________________________________________________________________________________________________|____________| * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 20 NTP Experiment-Test: 88122-07 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC ELMIRON Date: 04/23/01 Route: GAVAGE Time: 15:23:02 __________________________________________________________________________________________________________________________________ | 7| 7| 7| 7| 5| 4| 7| 0| 7| 7| 7| 7| 7| 5| 2| 7| 7| 7| 7| 7| 7| 6| 7| 7| 7| | DAY ON TEST | 3| 3| 3| 2| 5| 8| 3| 1| 3| 2| 2| 3| 2| 4| 8| 2| 3| 3| 2| 2| 1| 4| 2| 0| 2| | | 0| 0| 0| 9| 5| 5| 0| 8| 0| 9| 9| 0| 9| 1| 1| 9| 0| 0| 9| 9| 1| 2| 9| 3| 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 | B6C3F1 MICE 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 | 56 MG/KG | 7| 7| 7| 7| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 0| L | | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| | _____________________________________________________________________________________________________________________|____________| MUSCULOSKELETAL SYSTEM - cont | | | Fibrous Osteodystrophy | 2 | 1 2.0| _____________________________________________________________________________________________________________________| | NERVOUS SYSTEM | | | |__________________________________________________________________________|____________| Brain | + + + + + + + + + + + + + + + + + + + + + + + + +| 49 | _____________________________________________________________________________________________________________________| | RESPIRATORY SYSTEM | | | |__________________________________________________________________________|____________| Lung | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Infiltration Cellular, Lymphocyte | | 1 1.0| Inflammation, Chronic Active | | 1 1.0| Thrombosis | 2 | 1 2.0| Alveolar Epithelium, Hyperplasia | 2 | 3 1.7| Mediastinum, Inflammation, Acute | 4 | 1 4.0| |__________________________________________________________________________|____________| Nose | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Olfactory Epithelium, Atrophy | | 1 1.0| Olfactory Epithelium, Metaplasia | | 2 2.0| |__________________________________________________________________________|____________| Pleura | | 1 | |__________________________________________________________________________|____________| Trachea | + + + + + + + + + + + + + + A + + + + + + + + + +| 48 | Metaplasia, Squamous | 1 | 1 1.0| _____________________________________________________________________________________________________________________| | SPECIAL SENSES SYSTEM | | | |__________________________________________________________________________|____________| Harderian Gland | + + + + + + + + + + + + + + + M M M M + M M M M M| 41 | Atrophy | | 1 2.0| Hyperplasia | 3 | 3 2.3| _____________________________________________________________________________________________________________________| | URINARY SYSTEM | | | |__________________________________________________________________________|____________| Kidney | + + + + + A + + + + + + + + + + + + + + + + + + +| 49 | Cyst | 2 | 1 2.0| _____________________________________________________________________________________________________________________|____________| * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 21 NTP Experiment-Test: 88122-07 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC ELMIRON Date: 04/23/01 Route: GAVAGE Time: 15:23:02 __________________________________________________________________________________________________________________________________ | 7| 7| 7| 7| 5| 4| 7| 0| 7| 7| 7| 7| 7| 5| 2| 7| 7| 7| 7| 7| 7| 6| 7| 7| 7| | DAY ON TEST | 3| 3| 3| 2| 5| 8| 3| 1| 3| 2| 2| 3| 2| 4| 8| 2| 3| 3| 2| 2| 1| 4| 2| 0| 2| | | 0| 0| 0| 9| 5| 5| 0| 8| 0| 9| 9| 0| 9| 1| 1| 9| 0| 0| 9| 9| 1| 2| 9| 3| 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 | B6C3F1 MICE 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 | 56 MG/KG | 7| 7| 7| 7| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 0| L | | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| | _____________________________________________________________________________________________________________________|____________| URINARY SYSTEM - cont | | | Infarct | | 1 2.0| Mineralization | 1 | 2 1.5| Nephropathy | 2 1 1 1 1 1 1 1| 17 1.1| Renal Tubule, Accumulation, Hyaline | | | Droplet | | 1 3.0| |__________________________________________________________________________|____________| Ureter | A | | |__________________________________________________________________________|____________| Urethra | + | 1 | |__________________________________________________________________________|____________| Urinary Bladder | + + + + + + A + + + + + + + A + + + + + + A + + +| 46 | __________________________________________________________________________________________________________________________________ * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 22 NTP Experiment-Test: 88122-07 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC ELMIRON Date: 04/23/01 Route: GAVAGE Time: 15:23:02 _____________________________________________________________________________________________________________________ | 7| 7| 3| 7| 7| 7| 6| 7| 7| 7| 7| 7| 4| 7| 7| 7| 6| 7| 7| 7| 7| 6| 7| 7| 7| DAY ON TEST | 2| 2| 1| 2| 2| 3| 3| 2| 3| 3| 3| 3| 8| 3| 2| 3| 3| 2| 1| 3| 3| 0| 3| 3| 3| | 9| 9| 3| 9| 9| 0| 8| 9| 0| 0| 0| 0| 1| 0| 9| 0| 8| 9| 7| 0| 0| 3| 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| 0| 0| B6C3F1 MICE 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| 168 | 0| 0| 0| 0| 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 2| MG/KG | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| __________________________________________|__________________________________________________________________________| ALIMENTARY SYSTEM | | |__________________________________________________________________________| Esophagus | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Gallbladder | + + + + + + + + + M + + + M + + A M A + + A + + +| Cyst | | Degeneration, Hyaline | | |__________________________________________________________________________| Intestine Large, Colon | + + + + + + A + + + + + + + + + A + A + + A + + +| |__________________________________________________________________________| Intestine Large, Rectum | + + + + + + A + + + + + + + + + A + A + + A + + +| Infiltration Cellular, Histiocyte | | Inflammation, Chronic Active | | Metaplasia, Squamous | | Myxomatous Change | 1 1 1 1 1 1 1 1 | Necrosis | | |__________________________________________________________________________| Intestine Large, Cecum | + + + + + + A + + + + + + + + + A + A + + + + + +| Inflammation, Granulomatous | 2 | Necrosis | 4 | |__________________________________________________________________________| Intestine Small, Duodenum | + + + + + + A + + + + + + + + + A + A + + A + + +| |__________________________________________________________________________| Intestine Small, Jejunum | + + + + + + A + + + + + + + + + A + A + + A + + +| |__________________________________________________________________________| Intestine Small, Ileum | + + + + + + A + + + + + + + + + A + A + + A + + +| |__________________________________________________________________________| Liver | + + + + + + + + + + + + + + + + + + + + + + + + +| Angiectasis | 1 | Basophilic Focus | X X X X | Clear Cell Focus | | Eosinophilic Focus | X X X X X X | Fatty Change | 1 | Hematopoietic Cell Proliferation | 1 1 1 | Inflammation, Chronic | 1 1 2 1 1 1 2 1 1 1 1 1 1 1 1 1 1 2 1 1 1| Mineralization | | Tension Lipidosis | X | Centrilobular, Degeneration | 2 | |__________________________________________________________________________| __________________________________________|__________________________________________________________________________| Page 23 NTP Experiment-Test: 88122-07 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC ELMIRON Date: 04/23/01 Route: GAVAGE Time: 15:23:02 _____________________________________________________________________________________________________________________ | 7| 7| 3| 7| 7| 7| 6| 7| 7| 7| 7| 7| 4| 7| 7| 7| 6| 7| 7| 7| 7| 6| 7| 7| 7| DAY ON TEST | 2| 2| 1| 2| 2| 3| 3| 2| 3| 3| 3| 3| 8| 3| 2| 3| 3| 2| 1| 3| 3| 0| 3| 3| 3| | 9| 9| 3| 9| 9| 0| 8| 9| 0| 0| 0| 0| 1| 0| 9| 0| 8| 9| 7| 0| 0| 3| 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| 0| 0| B6C3F1 MICE 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| 168 | 0| 0| 0| 0| 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 2| MG/KG | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| __________________________________________|__________________________________________________________________________| ALIMENTARY SYSTEM - cont | | Mesentery | + + + + + + + + + + + + + + +| Fat, Necrosis | 2 2 3 2 2 2 2 2 2 2 3 1 2 2| |__________________________________________________________________________| Pancreas | + + + + + + + + + + + + + + + + A + + + + A + + +| |__________________________________________________________________________| Salivary Glands | + + + + + + + + + + + + + + + + + + + + + + + + +| Atrophy | | Infiltration Cellular, Lymphocyte | 2 | |__________________________________________________________________________| Stomach, Forestomach | + + + + + + + + + + + + + + + + + + + + + + + + +| Hyperplasia, Squamous | 2 | |__________________________________________________________________________| Stomach, Glandular | + + + + + + + + + + + + + + + + A + A + + A + + +| _____________________________________________________________________________________________________________________| CARDIOVASCULAR SYSTEM | | |__________________________________________________________________________| Heart | + + + + + + + + + + + + + + + + + + + + + + + + +| Cardiomyopathy | | Inflammation, Chronic Active | 1 | Mineralization | | _____________________________________________________________________________________________________________________| ENDOCRINE SYSTEM | | |__________________________________________________________________________| Adrenal Cortex | + + + + + + + + + + + + + + + + + + + + + A + + +| Hyperplasia | 1 1 | Hypertrophy | 1 1 1 | |__________________________________________________________________________| Adrenal Medulla | + + + + + + + + + + + + + + + + M + M + + A + + +| |__________________________________________________________________________| Islets, Pancreatic | + + + + + + + + + + + + + + + + A + A + + A + + +| |__________________________________________________________________________| Parathyroid Gland | + M + + + + I + + + + M + M I + + + M + + M + M +| |__________________________________________________________________________| Pituitary Gland | + + + + + + + + + + + + + + + + I + A + + + + + +| Pars Distalis, Hyperplasia | 1 2 1 2 | |__________________________________________________________________________| Thyroid Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________|__________________________________________________________________________| Page 24 NTP Experiment-Test: 88122-07 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC ELMIRON Date: 04/23/01 Route: GAVAGE Time: 15:23:02 _____________________________________________________________________________________________________________________ | 7| 7| 3| 7| 7| 7| 6| 7| 7| 7| 7| 7| 4| 7| 7| 7| 6| 7| 7| 7| 7| 6| 7| 7| 7| DAY ON TEST | 2| 2| 1| 2| 2| 3| 3| 2| 3| 3| 3| 3| 8| 3| 2| 3| 3| 2| 1| 3| 3| 0| 3| 3| 3| | 9| 9| 3| 9| 9| 0| 8| 9| 0| 0| 0| 0| 1| 0| 9| 0| 8| 9| 7| 0| 0| 3| 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| 0| 0| B6C3F1 MICE 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| 168 | 0| 0| 0| 0| 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 2| MG/KG | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| __________________________________________|__________________________________________________________________________| GENERAL BODY SYSTEM | | |__________________________________________________________________________| Peritoneum | + | _____________________________________________________________________________________________________________________| GENITAL SYSTEM | | |__________________________________________________________________________| Clitoral Gland | + M I + + + M + + + + + I + + + + + + M + + + + +| |__________________________________________________________________________| Ovary | + + + + + + + + + + + + + + + + + + A + + + + + +| Cyst | 4 3 2 3 | |__________________________________________________________________________| Uterus | + + + + + + + + + + + + + + + + + + + + + + + + +| Angiectasis | | Hydrometra | 3 3 4 1 4 2 3 2 2 1| Hyperplasia, Cystic | 3 1 1 | _____________________________________________________________________________________________________________________| HEMATOPOIETIC SYSTEM | | |__________________________________________________________________________| Bone Marrow | + + + + + + + + + + + + + + + + + + + + + + + + +| Necrosis | | |__________________________________________________________________________| Lymph Node | + | Mediastinal, Hyperplasia, Lymphoid | 3 | |__________________________________________________________________________| Lymph Node, Mandibular | M + M M + + + + + + + + + + + + M + M + + + + M +| Hyperplasia, Lymphoid | 4 4 | Infiltration Cellular, Plasma Cell | | |__________________________________________________________________________| Lymph Node, Mesenteric | + + + + + + A + + + + + M + + + A + A + + A + + +| Hemorrhage | 1 | Hyperplasia, Lymphoid | 4 4 | Infiltration Cellular, Plasma Cell | | Infiltration Cellular, Histiocyte | 3 2 2 1 3 2 1 2 2 1 1 1 1 2 2 3| |__________________________________________________________________________| Spleen | + + + + + + + + + + + + + + + + A + + + + + + + +| Hematopoietic Cell Proliferation | 1 1 2 2 2 2 1 2 1 | Infiltration Cellular, Histiocyte | 1 1 1 1 1 1 | |__________________________________________________________________________| Thymus | + + + + + + M + + + + + + + M + + M A I + A + + +| __________________________________________|__________________________________________________________________________| Page 25 NTP Experiment-Test: 88122-07 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC ELMIRON Date: 04/23/01 Route: GAVAGE Time: 15:23:02 _____________________________________________________________________________________________________________________ | 7| 7| 3| 7| 7| 7| 6| 7| 7| 7| 7| 7| 4| 7| 7| 7| 6| 7| 7| 7| 7| 6| 7| 7| 7| DAY ON TEST | 2| 2| 1| 2| 2| 3| 3| 2| 3| 3| 3| 3| 8| 3| 2| 3| 3| 2| 1| 3| 3| 0| 3| 3| 3| | 9| 9| 3| 9| 9| 0| 8| 9| 0| 0| 0| 0| 1| 0| 9| 0| 8| 9| 7| 0| 0| 3| 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| 0| 0| B6C3F1 MICE 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| 168 | 0| 0| 0| 0| 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 2| MG/KG | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| __________________________________________|__________________________________________________________________________| INTEGUMENTARY SYSTEM | | |__________________________________________________________________________| Mammary Gland | + + + + + + M + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Skin | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| MUSCULOSKELETAL SYSTEM | | |__________________________________________________________________________| Bone | + + + + + + + + + + + + + + + + + + + + + + + + +| Fibrous Osteodystrophy | 2 2 | |__________________________________________________________________________| Skeletal Muscle | | Degeneration | | Mineralization | | _____________________________________________________________________________________________________________________| NERVOUS SYSTEM | | |__________________________________________________________________________| Brain | + + + + + + + + + + + + + + + + + + + + + + + + +| Meninges, Infiltration Cellular, | | Mononuclear Cell | | _____________________________________________________________________________________________________________________| RESPIRATORY SYSTEM | | |__________________________________________________________________________| Lung | + + + + + + + + + + + + + + + + + + + + + + + + +| Alveolar Epithelium, Hyperplasia | | Alveolus, Infiltration Cellular, | | Histiocyte | 1 | |__________________________________________________________________________| Nose | + + + + + + + + + + + + + + + + + + + + + + + + +| Inflammation, Suppurative | | Olfactory Epithelium, Atrophy | 2 | |__________________________________________________________________________| Trachea | + + + + + + + + + + + + + + + + + + A + + A + + +| _____________________________________________________________________________________________________________________| SPECIAL SENSES SYSTEM | | |__________________________________________________________________________| Eye | + | Degeneration | 4 | |__________________________________________________________________________| __________________________________________|__________________________________________________________________________| Page 26 NTP Experiment-Test: 88122-07 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC ELMIRON Date: 04/23/01 Route: GAVAGE Time: 15:23:02 _____________________________________________________________________________________________________________________ | 7| 7| 3| 7| 7| 7| 6| 7| 7| 7| 7| 7| 4| 7| 7| 7| 6| 7| 7| 7| 7| 6| 7| 7| 7| DAY ON TEST | 2| 2| 1| 2| 2| 3| 3| 2| 3| 3| 3| 3| 8| 3| 2| 3| 3| 2| 1| 3| 3| 0| 3| 3| 3| | 9| 9| 3| 9| 9| 0| 8| 9| 0| 0| 0| 0| 1| 0| 9| 0| 8| 9| 7| 0| 0| 3| 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| 0| 0| B6C3F1 MICE 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| 168 | 0| 0| 0| 0| 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 2| MG/KG | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| __________________________________________|__________________________________________________________________________| SPECIAL SENSES SYSTEM - cont | | Harderian Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| Hyperplasia | 3 | _____________________________________________________________________________________________________________________| URINARY SYSTEM | | |__________________________________________________________________________| Kidney | + + + + + + + + + + + + + + + + + + A + + A + + +| Infarct | | Infiltration Cellular, Lymphocyte | 2 | Mineralization | | Nephropathy | 1 1 1 2 1 1 1 1 | |__________________________________________________________________________| Urinary Bladder | + + + + + + + + + + + + + + + + + + A + + A + + +| __________________________________________|__________________________________________________________________________ Page 27 NTP Experiment-Test: 88122-07 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC ELMIRON Date: 04/23/01 Route: GAVAGE Time: 15:23:02 __________________________________________________________________________________________________________________________________ | 7| 5| 7| 6| 7| 7| 7| 7| 7| 5| 7| 7| 6| 6| 7| 7| 7| 7| 6| 7| 7| 7| 6| 7| 7| | DAY ON TEST | 3| 0| 3| 4| 2| 2| 3| 2| 2| 8| 3| 2| 6| 7| 3| 2| 3| 3| 5| 2| 3| 2| 2| 2| 2| | | 0| 9| 0| 7| 9| 9| 0| 9| 9| 9| 0| 9| 7| 7| 0| 9| 0| 0| 3| 9| 0| 9| 1| 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 | B6C3F1 MICE 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 | 168 | 2| 2| 2| 2| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 5| L | MG/KG | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| | _____________________________________________________________________________________________________________________|____________| ALIMENTARY SYSTEM | | | |__________________________________________________________________________|____________| Esophagus | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Gallbladder | + + + A I + + + + M + + A A + + + + + + + + A + +| 38 | Cyst | 1 | 1 1.0| Degeneration, Hyaline | 3 2 3 | 3 2.7| |__________________________________________________________________________|____________| Intestine Large, Colon | + + + + + + + + + + + + A A + + + + + + + + + + +| 44 | |__________________________________________________________________________|____________| Intestine Large, Rectum | + + + + + + + + + + + + A A + + + + + + + + + + +| 44 | Infiltration Cellular, Histiocyte | 1 1 | 2 1.0| Inflammation, Chronic Active | 4 1 | 2 2.5| Metaplasia, Squamous | 2 | 1 2.0| Myxomatous Change | 1 2 1 2 1 1 1 1 1 1 1 2 1 | 21 1.1| Necrosis | 4 | 1 4.0| |__________________________________________________________________________|____________| Intestine Large, Cecum | + + + A + + + + + + + + A A + + + + + + + + + + +| 44 | Inflammation, Granulomatous | | 1 2.0| Necrosis | | 1 4.0| |__________________________________________________________________________|____________| Intestine Small, Duodenum | + + + A + + + + + + + + A A + + + + + + + + A + +| 42 | |__________________________________________________________________________|____________| Intestine Small, Jejunum | + + + A + + + + + + + + A A + + + + + + + + A + +| 42 | |__________________________________________________________________________|____________| Intestine Small, Ileum | + + + A + + + + + + + + A A + + + + + + + + A + +| 42 | |__________________________________________________________________________|____________| Liver | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Angiectasis | | 1 1.0| Basophilic Focus | X X X X | 8 | Clear Cell Focus | X | 1 | Eosinophilic Focus | X | 7 | Fatty Change | | 1 1.0| Hematopoietic Cell Proliferation | 1 1 | 5 1.0| Inflammation, Chronic | 1 2 1 1 1 1 1 1 1 2 1 1 1 1 1 1 1 1 1| 40 1.1| _____________________________________________________________________________________________________________________|____________| * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 28 NTP Experiment-Test: 88122-07 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC ELMIRON Date: 04/23/01 Route: GAVAGE Time: 15:23:02 __________________________________________________________________________________________________________________________________ | 7| 5| 7| 6| 7| 7| 7| 7| 7| 5| 7| 7| 6| 6| 7| 7| 7| 7| 6| 7| 7| 7| 6| 7| 7| | DAY ON TEST | 3| 0| 3| 4| 2| 2| 3| 2| 2| 8| 3| 2| 6| 7| 3| 2| 3| 3| 5| 2| 3| 2| 2| 2| 2| | | 0| 9| 0| 7| 9| 9| 0| 9| 9| 9| 0| 9| 7| 7| 0| 9| 0| 0| 3| 9| 0| 9| 1| 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 | B6C3F1 MICE 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 | 168 | 2| 2| 2| 2| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 5| L | MG/KG | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| | _____________________________________________________________________________________________________________________|____________| ALIMENTARY SYSTEM - cont | | | Mineralization | 2 | 1 2.0| Tension Lipidosis | | 1 | Centrilobular, Degeneration | | 1 2.0| |__________________________________________________________________________|____________| Mesentery | + + + + + + + + + + + + + + + + +| 32 | Fat, Necrosis | 2 2 3 2 2 2 2 2 2 2 2 3 2 2 2 2 2| 31 2.1| |__________________________________________________________________________|____________| Pancreas | + + + + + + + + + + + + A M + + + + + + + + + + +| 46 | |__________________________________________________________________________|____________| Salivary Glands | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Atrophy | 2 | 1 2.0| Infiltration Cellular, Lymphocyte | 2 | 2 2.0| |__________________________________________________________________________|____________| Stomach, Forestomach | + + + + + + + + + + + + A + + + + + + + + + + + +| 49 | Hyperplasia, Squamous | 2 | 2 2.0| |__________________________________________________________________________|____________| Stomach, Glandular | + + + + + + + + + + + + A A + + + + + + + + A + +| 44 | _____________________________________________________________________________________________________________________| | CARDIOVASCULAR SYSTEM | | | |__________________________________________________________________________|____________| Heart | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Cardiomyopathy | 2 | 1 2.0| Inflammation, Chronic Active | | 1 1.0| Mineralization | 2 | 1 2.0| _____________________________________________________________________________________________________________________| | ENDOCRINE SYSTEM | | | |__________________________________________________________________________|____________| Adrenal Cortex | + + + + + + + + + + + + + + + + + + + + + + + + +| 49 | Hyperplasia | | 2 1.0| Hypertrophy | | 3 1.0| |__________________________________________________________________________|____________| Adrenal Medulla | + + + + + + + + + + + + + + + + + + + + + + + + +| 47 | |__________________________________________________________________________|____________| Islets, Pancreatic | + + + + + + + + + + + + A M + + + + + + + + + + +| 45 | _____________________________________________________________________________________________________________________|____________| * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 29 NTP Experiment-Test: 88122-07 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC ELMIRON Date: 04/23/01 Route: GAVAGE Time: 15:23:02 __________________________________________________________________________________________________________________________________ | 7| 5| 7| 6| 7| 7| 7| 7| 7| 5| 7| 7| 6| 6| 7| 7| 7| 7| 6| 7| 7| 7| 6| 7| 7| | DAY ON TEST | 3| 0| 3| 4| 2| 2| 3| 2| 2| 8| 3| 2| 6| 7| 3| 2| 3| 3| 5| 2| 3| 2| 2| 2| 2| | | 0| 9| 0| 7| 9| 9| 0| 9| 9| 9| 0| 9| 7| 7| 0| 9| 0| 0| 3| 9| 0| 9| 1| 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 | B6C3F1 MICE 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 | 168 | 2| 2| 2| 2| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 5| L | MG/KG | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| | _____________________________________________________________________________________________________________________|____________| ENDOCRINE SYSTEM - cont | | | |__________________________________________________________________________|____________| Parathyroid Gland | M + M + + M + + + + + + M + M + + + + + + + + + +| 37 | |__________________________________________________________________________|____________| Pituitary Gland | + I + I + + M + + + + + + + + + + + + + + + + + +| 45 | Pars Distalis, Hyperplasia | 1 2 2 1 1 1 | 10 1.4| |__________________________________________________________________________|____________| Thyroid Gland | + + + + + + + + + + + + + A + + + + + + + + + + +| 49 | _____________________________________________________________________________________________________________________| | GENERAL BODY SYSTEM | | | |__________________________________________________________________________|____________| Peritoneum | | 1 | _____________________________________________________________________________________________________________________| | GENITAL SYSTEM | | | |__________________________________________________________________________|____________| Clitoral Gland | + M + + + + + + + + M + + + I + + + + + + + + + +| 42 | |__________________________________________________________________________|____________| Ovary | + + + + + + + + + + + + A + + + + + + + I + + + +| 47 | Cyst | 1 2 2 3 | 8 2.5| |__________________________________________________________________________|____________| Uterus | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Angiectasis | 3 | 1 3.0| Hydrometra | 3 1 3 2 3 3 2 2 3 3 2 4 2 2 2 | 25 2.5| Hyperplasia, Cystic | 1 2 2 2 1 | 8 1.6| _____________________________________________________________________________________________________________________| | HEMATOPOIETIC SYSTEM | | | |__________________________________________________________________________|____________| Bone Marrow | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Necrosis | 4 | 1 4.0| |__________________________________________________________________________|____________| Lymph Node | + + + + | 5 | Mediastinal, Hyperplasia, Lymphoid | | 1 3.0| |__________________________________________________________________________|____________| Lymph Node, Mandibular | + + + + + M + + + + M + + M + M + + + + M + M + M| 37 | Hyperplasia, Lymphoid | 2 | 3 3.3| _____________________________________________________________________________________________________________________|____________| * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 30 NTP Experiment-Test: 88122-07 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC ELMIRON Date: 04/23/01 Route: GAVAGE Time: 15:23:02 __________________________________________________________________________________________________________________________________ | 7| 5| 7| 6| 7| 7| 7| 7| 7| 5| 7| 7| 6| 6| 7| 7| 7| 7| 6| 7| 7| 7| 6| 7| 7| | DAY ON TEST | 3| 0| 3| 4| 2| 2| 3| 2| 2| 8| 3| 2| 6| 7| 3| 2| 3| 3| 5| 2| 3| 2| 2| 2| 2| | | 0| 9| 0| 7| 9| 9| 0| 9| 9| 9| 0| 9| 7| 7| 0| 9| 0| 0| 3| 9| 0| 9| 1| 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 | B6C3F1 MICE 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 | 168 | 2| 2| 2| 2| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 5| L | MG/KG | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| | _____________________________________________________________________________________________________________________|____________| HEMATOPOIETIC SYSTEM - cont | | | Infiltration Cellular, Plasma Cell | 2 | 1 2.0| |__________________________________________________________________________|____________| Lymph Node, Mesenteric | + + + + + + + + + + + M A A + + + + + + + + + + +| 42 | Hemorrhage | | 1 1.0| Hyperplasia, Lymphoid | 4 | 3 4.0| Infiltration Cellular, Plasma Cell | 4 | 1 4.0| Infiltration Cellular, Histiocyte | 3 1 2 2 2 1 2 2 2 1 2 2 2 2 2 2 2 2 2| 35 1.9| |__________________________________________________________________________|____________| Spleen | + + + + + + + + + + + + A M + + + + + + + + + + +| 47 | Hematopoietic Cell Proliferation | 1 1 1 3 1 3 | 15 1.6| Infiltration Cellular, Histiocyte | 1 1 1 1 1 1| 12 1.0| |__________________________________________________________________________|____________| Thymus | + + + + + + + + + + + + + M + + + + + + + + + + +| 43 | _____________________________________________________________________________________________________________________| | INTEGUMENTARY SYSTEM | | | |__________________________________________________________________________|____________| Mammary Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| 49 | |__________________________________________________________________________|____________| Skin | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | _____________________________________________________________________________________________________________________| | MUSCULOSKELETAL SYSTEM | | | |__________________________________________________________________________|____________| Bone | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Fibrous Osteodystrophy | 2 2 1 | 5 1.8| |__________________________________________________________________________|____________| Skeletal Muscle | + + | 2 | Degeneration | 3 | 1 3.0| Mineralization | 3 | 1 3.0| _____________________________________________________________________________________________________________________| | NERVOUS SYSTEM | | | |__________________________________________________________________________|____________| Brain | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Meninges, Infiltration Cellular, | | | Mononuclear Cell | 1 | 1 1.0| _____________________________________________________________________________________________________________________|____________| * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 31 NTP Experiment-Test: 88122-07 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC ELMIRON Date: 04/23/01 Route: GAVAGE Time: 15:23:02 __________________________________________________________________________________________________________________________________ | 7| 5| 7| 6| 7| 7| 7| 7| 7| 5| 7| 7| 6| 6| 7| 7| 7| 7| 6| 7| 7| 7| 6| 7| 7| | DAY ON TEST | 3| 0| 3| 4| 2| 2| 3| 2| 2| 8| 3| 2| 6| 7| 3| 2| 3| 3| 5| 2| 3| 2| 2| 2| 2| | | 0| 9| 0| 7| 9| 9| 0| 9| 9| 9| 0| 9| 7| 7| 0| 9| 0| 0| 3| 9| 0| 9| 1| 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 | B6C3F1 MICE 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 | 168 | 2| 2| 2| 2| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 5| L | MG/KG | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| | _____________________________________________________________________________________________________________________|____________| RESPIRATORY SYSTEM | | | |__________________________________________________________________________|____________| Lung | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Alveolar Epithelium, Hyperplasia | 1 | 1 1.0| Alveolus, Infiltration Cellular, | | | Histiocyte | 1 | 2 1.0| |__________________________________________________________________________|____________| Nose | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Inflammation, Suppurative | 2 2 | 2 2.0| Olfactory Epithelium, Atrophy | | 1 2.0| |__________________________________________________________________________|____________| Trachea | + + + + + + + + + + + + A A + + + + + + + + + + +| 46 | _____________________________________________________________________________________________________________________| | SPECIAL SENSES SYSTEM | | | |__________________________________________________________________________|____________| Eye | | 1 | Degeneration | | 1 4.0| |__________________________________________________________________________|____________| Harderian Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Hyperplasia | 2 | 2 2.5| _____________________________________________________________________________________________________________________| | URINARY SYSTEM | | | |__________________________________________________________________________|____________| Kidney | + + + + + + + + + + + + + + + + + + + + + + + + +| 48 | Infarct | 3 | 1 3.0| Infiltration Cellular, Lymphocyte | | 1 2.0| Mineralization | 1 | 1 1.0| Nephropathy | 1 1 1 1 1 1 1 1 1 1 3 1 1 1 | 22 1.1| |__________________________________________________________________________|____________| Urinary Bladder | + + + A + + + + + + + + + + + + + + + + + + + + +| 47 | __________________________________________________________________________________________________________________________________ * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 32 NTP Experiment-Test: 88122-07 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC ELMIRON Date: 04/23/01 Route: GAVAGE Time: 15:23:02 _____________________________________________________________________________________________________________________ | 5| 7| 7| 6| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 6| 7| 7| 7| 7| 7| 4| 5| 7| 6| 7| DAY ON TEST | 1| 2| 0| 6| 2| 3| 2| 3| 2| 3| 0| 2| 1| 3| 6| 3| 3| 2| 3| 2| 0| 0| 3| 2| 3| | 7| 9| 3| 0| 9| 0| 9| 0| 9| 0| 8| 9| 7| 0| 1| 0| 0| 9| 0| 3| 1| 9| 0| 1| 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| B6C3F1 MICE 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| 504 | 5| 5| 5| 5| 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 7| MG/KG | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| __________________________________________|__________________________________________________________________________| ALIMENTARY SYSTEM | | |__________________________________________________________________________| Esophagus | + + + + + + + + + + + + + + + + + + + + + + + + +| Inflammation, Chronic Active | 2 | |__________________________________________________________________________| Gallbladder | A + + A + M + + + + A + + + + + M + + A + + + + +| Cyst | | Degeneration, Hyaline | 3 | |__________________________________________________________________________| Intestine Large, Colon | + + + A + + + + + + A + + + + + + + + A + + + + +| Necrosis | 1 | |__________________________________________________________________________| Intestine Large, Rectum | I + + + + + + + + + A + + + + + + + + A + + + + +| Infiltration Cellular, Histiocyte | 1 1 1 1 1 1 1 | Inflammation, Chronic Active | 1 1 1 2 3 3 2 1 1 3 2 1 1 2 3 2 3| Metaplasia, Squamous | 2 3 1 2 3 1 2 1 3 3 1 3 1 1 | Myxomatous Change | 2 3 2 1 2 2 1 3 2 1 2 1 1 2 2 2| Necrosis | 2 2 2 3 2 2 1 3 2 2| |__________________________________________________________________________| Intestine Large, Cecum | A + + A + + + + + + A + + + + + + + + A + + + + +| Ulcer | | |__________________________________________________________________________| Intestine Small, Duodenum | A + + A + + + + + + A + + + + + + + + A M + + + +| |__________________________________________________________________________| Intestine Small, Jejunum | + + + A + + + + + + A + + + + + + + + A + + + + +| Inflammation, Acute | | |__________________________________________________________________________| Intestine Small, Ileum | A + + A + + + + + + A + + + + + + + + A + + + + +| Infiltration Cellular, Mixed Cell | | |__________________________________________________________________________| Liver | + + + + + + + + + + A + + + + + + + + + + + + + +| Basophilic Focus | X X X X X X X X| Clear Cell Focus | X X X X X X X X X X X | Eosinophilic Focus | X X X X X X X | Fatty Change | 1 1 2 1 1 | Hematopoietic Cell Proliferation | 2 2 3 1 1 | Inflammation, Chronic | 2 3 3 1 3 2 2 2 1 1 3 2 2 1 1 1 2 2| Centrilobular, Degeneration | | Centrilobular, Necrosis | | __________________________________________|__________________________________________________________________________| Page 33 NTP Experiment-Test: 88122-07 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC ELMIRON Date: 04/23/01 Route: GAVAGE Time: 15:23:02 _____________________________________________________________________________________________________________________ | 5| 7| 7| 6| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 6| 7| 7| 7| 7| 7| 4| 5| 7| 6| 7| DAY ON TEST | 1| 2| 0| 6| 2| 3| 2| 3| 2| 3| 0| 2| 1| 3| 6| 3| 3| 2| 3| 2| 0| 0| 3| 2| 3| | 7| 9| 3| 0| 9| 0| 9| 0| 9| 0| 8| 9| 7| 0| 1| 0| 0| 9| 0| 3| 1| 9| 0| 1| 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| B6C3F1 MICE 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| 504 | 5| 5| 5| 5| 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 7| MG/KG | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| __________________________________________|__________________________________________________________________________| ALIMENTARY SYSTEM - cont | | |__________________________________________________________________________| Mesentery | + + + + + + + + + + + + + + + + + + + + +| Inflammation, Chronic Active | | Thrombosis | | Fat, Necrosis | 1 2 3 1 2 2 2 3 2 2 2 2 2 2 2 2 2 2 2 2 2| |__________________________________________________________________________| Pancreas | + + + A + + + + + + A + + + + + + + + A + + + + +| Atrophy | 1 | Basophilic Focus | | |__________________________________________________________________________| Salivary Glands | + + + + + + + + + + M + + + + + + + + + + + + + +| |__________________________________________________________________________| Stomach, Forestomach | + + + + + + + + + + + + + + + + + + + A + + + + +| |__________________________________________________________________________| Stomach, Glandular | + + + A + + + + + + A + + + + + + + + A + + + + +| _____________________________________________________________________________________________________________________| CARDIOVASCULAR SYSTEM | | |__________________________________________________________________________| Heart | + + + + + + + + + + + + + + + + + + + + + + + + +| Cardiomyopathy | 1 | Mineralization | | _____________________________________________________________________________________________________________________| ENDOCRINE SYSTEM | | |__________________________________________________________________________| Adrenal Cortex | + + + + + + + + + + A + + + + + + + + + + + + + +| Hyperplasia | 3 | Hypertrophy | 2 2 3 1 1 2 2 1| Necrosis | 2 | |__________________________________________________________________________| Adrenal Medulla | + + + M + + + + + + A + + + + + + + + + + + + + +| |__________________________________________________________________________| Islets, Pancreatic | + + + A + + + + + + A + + + + + + + + A + + + + +| |__________________________________________________________________________| Parathyroid Gland | + + + + M M + + + + + + + M + + + + + A + + + + +| |__________________________________________________________________________| Pituitary Gland | + + + + + + + + + + + + + + + + + + + A + + + + +| Pars Distalis, Hyperplasia | 3 1 1 | |__________________________________________________________________________| __________________________________________|__________________________________________________________________________| Page 34 NTP Experiment-Test: 88122-07 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC ELMIRON Date: 04/23/01 Route: GAVAGE Time: 15:23:02 _____________________________________________________________________________________________________________________ | 5| 7| 7| 6| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 6| 7| 7| 7| 7| 7| 4| 5| 7| 6| 7| DAY ON TEST | 1| 2| 0| 6| 2| 3| 2| 3| 2| 3| 0| 2| 1| 3| 6| 3| 3| 2| 3| 2| 0| 0| 3| 2| 3| | 7| 9| 3| 0| 9| 0| 9| 0| 9| 0| 8| 9| 7| 0| 1| 0| 0| 9| 0| 3| 1| 9| 0| 1| 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| B6C3F1 MICE 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| 504 | 5| 5| 5| 5| 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 7| MG/KG | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| __________________________________________|__________________________________________________________________________| ENDOCRINE SYSTEM - cont | | Thyroid Gland | + + + + + + + + + + A + + + + + + + + A + + + + +| _____________________________________________________________________________________________________________________| GENERAL BODY SYSTEM | | None | | _____________________________________________________________________________________________________________________| GENITAL SYSTEM | | |__________________________________________________________________________| Clitoral Gland | + + M I + + + + + M + + M + + M + + + M I M + + +| |__________________________________________________________________________| Ovary | + + + + + + + + + + + + + + + + + + + A + + + + +| Angiectasis | | Cyst | 2 2 | |__________________________________________________________________________| Uterus | + + + + + + + + + + + + + + + + + + + + + + + + +| Angiectasis | | Hydrometra | 1 3 3 1 3 3 2 1 2 2 | Hyperplasia, Cystic | 2 3 2| _____________________________________________________________________________________________________________________| HEMATOPOIETIC SYSTEM | | |__________________________________________________________________________| Bone Marrow | + + + + + + + + + + + + + + + + + + + + + + + + +| Atrophy | 2 | |__________________________________________________________________________| Lymph Node | + + + A + + | Pancreatic, Hyperplasia, Lymphoid | | |__________________________________________________________________________| Lymph Node, Mandibular | + + + M + + + + + + M + + + + + + + + I + + M + +| Infiltration Cellular, Plasma Cell | 4 3 | Infiltration Cellular, Histiocyte | 1 1 1 | |__________________________________________________________________________| Lymph Node, Mesenteric | + + + A + + + + + + A + + + M + + + + A + + + + +| Hemorrhage | 2 1 | Infiltration Cellular, Plasma Cell | 2 4 | Infiltration Cellular, Histiocyte | 3 2 2 2 2 1 1 2 1 3 2 2 | |__________________________________________________________________________| Spleen | + + + A + + + + + + A + + + + + + + + A + + + + +| Congestion | | Hematopoietic Cell Proliferation | 2 3 3 2 2 1 | __________________________________________|__________________________________________________________________________| Page 35 NTP Experiment-Test: 88122-07 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC ELMIRON Date: 04/23/01 Route: GAVAGE Time: 15:23:02 _____________________________________________________________________________________________________________________ | 5| 7| 7| 6| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 6| 7| 7| 7| 7| 7| 4| 5| 7| 6| 7| DAY ON TEST | 1| 2| 0| 6| 2| 3| 2| 3| 2| 3| 0| 2| 1| 3| 6| 3| 3| 2| 3| 2| 0| 0| 3| 2| 3| | 7| 9| 3| 0| 9| 0| 9| 0| 9| 0| 8| 9| 7| 0| 1| 0| 0| 9| 0| 3| 1| 9| 0| 1| 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| B6C3F1 MICE 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| 504 | 5| 5| 5| 5| 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 7| MG/KG | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| __________________________________________|__________________________________________________________________________| HEMATOPOIETIC SYSTEM - cont | | Infiltration Cellular, Histiocyte | 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1| Metaplasia, Osseous | 2 2 | |__________________________________________________________________________| Thymus | + + M A M M + M + M + + + + + + + + + M M + + + +| _____________________________________________________________________________________________________________________| INTEGUMENTARY SYSTEM | | |__________________________________________________________________________| Mammary Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Skin | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| MUSCULOSKELETAL SYSTEM | | |__________________________________________________________________________| Bone | + + + + + + + + + + + + + + + + + + + + + + + + +| Fibrous Osteodystrophy | 1 2 | _____________________________________________________________________________________________________________________| NERVOUS SYSTEM | | |__________________________________________________________________________| Brain | + + + + + + + + + + + + + + + + + + + + + + + + +| Meninges, Inflammation, Chronic | 2 | |__________________________________________________________________________| Peripheral Nerve | + | Infiltration Cellular, Mast Cell | 1 | |__________________________________________________________________________| Spinal Cord | + | _____________________________________________________________________________________________________________________| RESPIRATORY SYSTEM | | |__________________________________________________________________________| Lung | + + + + + + + + + + + + + + + + + + + + + + + + +| Inflammation, Chronic Active | 1 | Thrombosis | | Alveolar Epithelium, Hyperplasia | 1 | Alveolus, Infiltration Cellular, | | Histiocyte | 1 | |__________________________________________________________________________| Nose | + + + + + + + + + + + + + + + + + + + + + + + + +| Inflammation, Suppurative | 2 | Olfactory Epithelium, Atrophy | | __________________________________________|__________________________________________________________________________| Page 36 NTP Experiment-Test: 88122-07 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC ELMIRON Date: 04/23/01 Route: GAVAGE Time: 15:23:02 _____________________________________________________________________________________________________________________ | 5| 7| 7| 6| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 6| 7| 7| 7| 7| 7| 4| 5| 7| 6| 7| DAY ON TEST | 1| 2| 0| 6| 2| 3| 2| 3| 2| 3| 0| 2| 1| 3| 6| 3| 3| 2| 3| 2| 0| 0| 3| 2| 3| | 7| 9| 3| 0| 9| 0| 9| 0| 9| 0| 8| 9| 7| 0| 1| 0| 0| 9| 0| 3| 1| 9| 0| 1| 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| B6C3F1 MICE 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| 504 | 5| 5| 5| 5| 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 7| MG/KG | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| __________________________________________|__________________________________________________________________________| RESPIRATORY SYSTEM - cont | | Olfactory Epithelium, Metaplasia | 2 | |__________________________________________________________________________| Trachea | + + + + + + + + + + + + + + + + + + + A + + + + +| _____________________________________________________________________________________________________________________| SPECIAL SENSES SYSTEM | | |__________________________________________________________________________| Eye | | Cornea, Inflammation, Acute | | Cornea, Inflammation, Chronic | | |__________________________________________________________________________| Harderian Gland | + + M M + + + + + + + + + + + + + + + + + + + + +| Hyperplasia | 1 4 4 | Inflammation, Chronic | 2 | _____________________________________________________________________________________________________________________| URINARY SYSTEM | | |__________________________________________________________________________| Kidney | + + + + + + + + + + A + + + + + + + + A + + + + +| Infarct | | Metaplasia, Osseous | 1 | Mineralization | 1 | Nephropathy | 1 1 1 1 1 1 1 1 2 1 1 1 1 4 1 1 1| Renal Tubule, Vacuolization | | Cytoplasmic | | |__________________________________________________________________________| Urinary Bladder | + + + A + + + + + + A + + + + + + + + + + + + + +| __________________________________________|__________________________________________________________________________ Page 37 NTP Experiment-Test: 88122-07 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC ELMIRON Date: 04/23/01 Route: GAVAGE Time: 15:23:02 __________________________________________________________________________________________________________________________________ | 6| 7| 7| 7| 6| 7| 5| 7| 7| 7| 7| 7| 7| 6| 7| 7| 7| 7| 7| 6| 7| 7| 7| 7| 7| | DAY ON TEST | 5| 2| 2| 0| 8| 3| 7| 3| 2| 3| 3| 3| 2| 9| 2| 2| 3| 3| 2| 4| 2| 3| 2| 2| 2| | | 2| 9| 9| 1| 3| 0| 9| 0| 9| 0| 0| 0| 9| 8| 9| 9| 0| 0| 9| 5| 9| 0| 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 | B6C3F1 MICE 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| 4| A | 504 | 7| 7| 7| 7| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 0| L | MG/KG | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| | _____________________________________________________________________________________________________________________|____________| ALIMENTARY SYSTEM | | | |__________________________________________________________________________|____________| Esophagus | + + + + + + + + + + + + + + + + + + + A + + + + +| 49 | Inflammation, Chronic Active | | 1 2.0| |__________________________________________________________________________|____________| Gallbladder | A + + A A + + + + + + + + A M + + + + A + + + + +| 38 | Cyst | 2 | 1 2.0| Degeneration, Hyaline | 4 | 2 3.5| |__________________________________________________________________________|____________| Intestine Large, Colon | + + + + + + + + + + + + + + + + + + + A + + + + +| 46 | Necrosis | | 1 1.0| |__________________________________________________________________________|____________| Intestine Large, Rectum | + + + + + + + + + + + + + + + + + + + A + + + + +| 46 | Infiltration Cellular, Histiocyte | 1 1 1 | 10 1.0| Inflammation, Chronic Active | 1 3 2 1 2 2 2 2 2 3 3 2 3 3 4| 32 2.1| Metaplasia, Squamous | 1 4 1 4 1 2 1 2 1 2 4 2| 26 2.0| Myxomatous Change | 2 2 1 1 3 1 1 1 1 2 2 2 2 1 2 | 31 1.7| Necrosis | 2 1 1 1 4 2 2 1 3 3 2 2 1 3| 24 2.0| |__________________________________________________________________________|____________| Intestine Large, Cecum | A + + + + + + + + + + + + A + + + + + A + + + + +| 43 | Ulcer | 1 | 1 1.0| |__________________________________________________________________________|____________| Intestine Small, Duodenum | A + + + A + + + + + + + + + + + + + + A + + + + +| 42 | |__________________________________________________________________________|____________| Intestine Small, Jejunum | A + + A A + + + + + + + + A + + + + + A + + + + +| 42 | Inflammation, Acute | 2 | 1 2.0| |__________________________________________________________________________|____________| Intestine Small, Ileum | A + + A A + + + + + + + + + + + + + + A + + + + +| 42 | Infiltration Cellular, Mixed Cell | 3 | 1 3.0| |__________________________________________________________________________|____________| Liver | + + + + + + + + + + + + + + + + + + + + + + + + +| 49 | Basophilic Focus | X X X X | 12 | Clear Cell Focus | X X X X X X X X X X | 21 | Eosinophilic Focus | X X X X X X X X | 15 | Fatty Change | 2 1 2 4 2 1 1 | 12 1.6| _____________________________________________________________________________________________________________________|____________| * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 38 NTP Experiment-Test: 88122-07 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC ELMIRON Date: 04/23/01 Route: GAVAGE Time: 15:23:02 __________________________________________________________________________________________________________________________________ | 6| 7| 7| 7| 6| 7| 5| 7| 7| 7| 7| 7| 7| 6| 7| 7| 7| 7| 7| 6| 7| 7| 7| 7| 7| | DAY ON TEST | 5| 2| 2| 0| 8| 3| 7| 3| 2| 3| 3| 3| 2| 9| 2| 2| 3| 3| 2| 4| 2| 3| 2| 2| 2| | | 2| 9| 9| 1| 3| 0| 9| 0| 9| 0| 0| 0| 9| 8| 9| 9| 0| 0| 9| 5| 9| 0| 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 | B6C3F1 MICE 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| 4| A | 504 | 7| 7| 7| 7| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 0| L | MG/KG | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| | _____________________________________________________________________________________________________________________|____________| ALIMENTARY SYSTEM - cont | | | Hematopoietic Cell Proliferation | 4 1 | 7 2.0| Inflammation, Chronic | 1 1 2 1 1 1 3 2 1 1 1 2 2 2 2 1 1 2 3 2| 38 1.7| Centrilobular, Degeneration | 2 | 1 2.0| Centrilobular, Necrosis | 2 | 1 2.0| |__________________________________________________________________________|____________| Mesentery | + + + + + + + + + + + + + + + + + + + + +| 42 | Inflammation, Chronic Active | 2 | 1 2.0| Thrombosis | 3 | 1 3.0| Fat, Necrosis | 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 3 2 2| 41 2.0| |__________________________________________________________________________|____________| Pancreas | + + + + + + + + + + + + + + + + + + + A + + + + +| 46 | Atrophy | | 1 1.0| Basophilic Focus | X | 1 | |__________________________________________________________________________|____________| Salivary Glands | + + + + + + + + + + + + + + + + + + + M + + + + +| 48 | |__________________________________________________________________________|____________| Stomach, Forestomach | + + + + + + + + + + + + + + + + + + + A + + + + +| 48 | |__________________________________________________________________________|____________| Stomach, Glandular | + + + + + + + + + + + + + + + + + + + A + + + + +| 46 | _____________________________________________________________________________________________________________________| | CARDIOVASCULAR SYSTEM | | | |__________________________________________________________________________|____________| Heart | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Cardiomyopathy | | 1 1.0| Mineralization | 2 | 1 2.0| _____________________________________________________________________________________________________________________| | ENDOCRINE SYSTEM | | | |__________________________________________________________________________|____________| Adrenal Cortex | + + + + + + + + + + + + + + + + + + + A + + + + +| 48 | Hyperplasia | 1 | 2 2.0| Hypertrophy | 2 1 1 2| 12 1.7| Necrosis | | 1 2.0| |__________________________________________________________________________|____________| Adrenal Medulla | + + + + + + + + + + + + + + + + + + + A + + + + +| 47 | _____________________________________________________________________________________________________________________|____________| * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 39 NTP Experiment-Test: 88122-07 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC ELMIRON Date: 04/23/01 Route: GAVAGE Time: 15:23:02 __________________________________________________________________________________________________________________________________ | 6| 7| 7| 7| 6| 7| 5| 7| 7| 7| 7| 7| 7| 6| 7| 7| 7| 7| 7| 6| 7| 7| 7| 7| 7| | DAY ON TEST | 5| 2| 2| 0| 8| 3| 7| 3| 2| 3| 3| 3| 2| 9| 2| 2| 3| 3| 2| 4| 2| 3| 2| 2| 2| | | 2| 9| 9| 1| 3| 0| 9| 0| 9| 0| 0| 0| 9| 8| 9| 9| 0| 0| 9| 5| 9| 0| 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 | B6C3F1 MICE 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| 4| A | 504 | 7| 7| 7| 7| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 0| L | MG/KG | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| | _____________________________________________________________________________________________________________________|____________| ENDOCRINE SYSTEM - cont | | | |__________________________________________________________________________|____________| Islets, Pancreatic | + + + + + + + + + + + + + + + + + + + A + + + + +| 46 | |__________________________________________________________________________|____________| Parathyroid Gland | + + + M + + + + + + + + + M + M M + + A + + + M +| 40 | |__________________________________________________________________________|____________| Pituitary Gland | + + + + + + + + + + + + + + + + + + + A + + + + +| 48 | Pars Distalis, Hyperplasia | 2 2 2 1 1 2 2 3 | 11 1.8| |__________________________________________________________________________|____________| Thyroid Gland | + + + + + + + + + + + + + + + + + + + A + + + M +| 46 | _____________________________________________________________________________________________________________________| | GENERAL BODY SYSTEM | | | None | | | _____________________________________________________________________________________________________________________| | GENITAL SYSTEM | | | |__________________________________________________________________________|____________| Clitoral Gland | M + + + M + + + + + + + M M + M + + + M + I + + +| 35 | |__________________________________________________________________________|____________| Ovary | + + + + + + + + + + + + + + + + + + + M + + + + +| 48 | Angiectasis | 2 4 | 2 3.0| Cyst | 2 2 3 2 2 | 7 2.1| |__________________________________________________________________________|____________| Uterus | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Angiectasis | 4 | 1 4.0| Hydrometra | 2 4 1 2 2 1 3 2 1 3| 20 2.1| Hyperplasia, Cystic | 2 2 2 2 3 2 3 | 10 2.3| _____________________________________________________________________________________________________________________| | HEMATOPOIETIC SYSTEM | | | |__________________________________________________________________________|____________| Bone Marrow | + + + + + + + + + + + + + + + + + + + A + + + + +| 49 | Atrophy | | 1 2.0| |__________________________________________________________________________|____________| Lymph Node | + + + + + | 10 | Pancreatic, Hyperplasia, Lymphoid | 4 | 1 4.0| |__________________________________________________________________________|____________| _____________________________________________________________________________________________________________________|____________| * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 40 NTP Experiment-Test: 88122-07 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC ELMIRON Date: 04/23/01 Route: GAVAGE Time: 15:23:02 __________________________________________________________________________________________________________________________________ | 6| 7| 7| 7| 6| 7| 5| 7| 7| 7| 7| 7| 7| 6| 7| 7| 7| 7| 7| 6| 7| 7| 7| 7| 7| | DAY ON TEST | 5| 2| 2| 0| 8| 3| 7| 3| 2| 3| 3| 3| 2| 9| 2| 2| 3| 3| 2| 4| 2| 3| 2| 2| 2| | | 2| 9| 9| 1| 3| 0| 9| 0| 9| 0| 0| 0| 9| 8| 9| 9| 0| 0| 9| 5| 9| 0| 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 | B6C3F1 MICE 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| 4| A | 504 | 7| 7| 7| 7| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 0| L | MG/KG | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| | _____________________________________________________________________________________________________________________|____________| HEMATOPOIETIC SYSTEM - cont | | | Lymph Node, Mandibular | M + + + + M + M + + + M M + + + M + + M + + + + +| 39 | Infiltration Cellular, Plasma Cell | | 2 3.5| Infiltration Cellular, Histiocyte | | 3 1.0| |__________________________________________________________________________|____________| Lymph Node, Mesenteric | + + + + + + + + + + + + + + + + + + + A + + + + +| 45 | Hemorrhage | 3 | 3 2.0| Infiltration Cellular, Plasma Cell | | 2 3.0| Infiltration Cellular, Histiocyte | 2 3 2 3 2 2 3 2 1 1 2 2 2| 25 2.0| |__________________________________________________________________________|____________| Spleen | + + + + + + + + + + + + + + + + + + + A + + + + +| 46 | Congestion | 2 | 1 2.0| Hematopoietic Cell Proliferation | 1 3 4 2 1 2 2 3 1 1 2 2 | 18 2.1| Infiltration Cellular, Histiocyte | 1 1 1 1 1 1 1 1 1 1 1 1 1| 28 1.0| Metaplasia, Osseous | | 2 2.0| |__________________________________________________________________________|____________| Thymus | + + + + + I + + + + + + + M + M M + + A M + + + +| 36 | _____________________________________________________________________________________________________________________| | INTEGUMENTARY SYSTEM | | | |__________________________________________________________________________|____________| Mammary Gland | + + + M + + + + + + + + + + + + + + + + + + + + +| 49 | |__________________________________________________________________________|____________| Skin | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | _____________________________________________________________________________________________________________________| | MUSCULOSKELETAL SYSTEM | | | |__________________________________________________________________________|____________| Bone | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Fibrous Osteodystrophy | 2 2 2 | 5 1.8| _____________________________________________________________________________________________________________________| | NERVOUS SYSTEM | | | |__________________________________________________________________________|____________| Brain | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Meninges, Inflammation, Chronic | | 1 2.0| |__________________________________________________________________________|____________| Peripheral Nerve | | 1 | _____________________________________________________________________________________________________________________|____________| * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 41 NTP Experiment-Test: 88122-07 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC ELMIRON Date: 04/23/01 Route: GAVAGE Time: 15:23:02 __________________________________________________________________________________________________________________________________ | 6| 7| 7| 7| 6| 7| 5| 7| 7| 7| 7| 7| 7| 6| 7| 7| 7| 7| 7| 6| 7| 7| 7| 7| 7| | DAY ON TEST | 5| 2| 2| 0| 8| 3| 7| 3| 2| 3| 3| 3| 2| 9| 2| 2| 3| 3| 2| 4| 2| 3| 2| 2| 2| | | 2| 9| 9| 1| 3| 0| 9| 0| 9| 0| 0| 0| 9| 8| 9| 9| 0| 0| 9| 5| 9| 0| 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 | B6C3F1 MICE 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| 4| A | 504 | 7| 7| 7| 7| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 0| L | MG/KG | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| | _____________________________________________________________________________________________________________________|____________| NERVOUS SYSTEM - cont | | | Infiltration Cellular, Mast Cell | | 1 1.0| |__________________________________________________________________________|____________| Spinal Cord | | 1 | _____________________________________________________________________________________________________________________| | RESPIRATORY SYSTEM | | | |__________________________________________________________________________|____________| Lung | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Inflammation, Chronic Active | | 1 1.0| Thrombosis | 1 | 1 1.0| Alveolar Epithelium, Hyperplasia | | 1 1.0| Alveolus, Infiltration Cellular, | | | Histiocyte | 2 | 2 1.5| |__________________________________________________________________________|____________| Nose | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Inflammation, Suppurative | 1 | 2 1.5| Olfactory Epithelium, Atrophy | 2 | 1 2.0| Olfactory Epithelium, Metaplasia | | 1 2.0| |__________________________________________________________________________|____________| Trachea | + + + + + + + + + + + + + + + + + + + A + + + + +| 48 | _____________________________________________________________________________________________________________________| | SPECIAL SENSES SYSTEM | | | |__________________________________________________________________________|____________| Eye | + + | 2 | Cornea, Inflammation, Acute | 4 | 1 4.0| Cornea, Inflammation, Chronic | 2 | 1 2.0| |__________________________________________________________________________|____________| Harderian Gland | + + + + + + + + + + + + + + + + + + + + + + +| 46 | Hyperplasia | 2 | 4 2.8| Inflammation, Chronic | | 1 2.0| _____________________________________________________________________________________________________________________| | URINARY SYSTEM | | | |__________________________________________________________________________|____________| Kidney | A + + + + + + + + + + + + + + + + + + A + + + + +| 46 | Infarct | 1 | 1 1.0| _____________________________________________________________________________________________________________________|____________| * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 42 NTP Experiment-Test: 88122-07 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC ELMIRON Date: 04/23/01 Route: GAVAGE Time: 15:23:02 __________________________________________________________________________________________________________________________________ | 6| 7| 7| 7| 6| 7| 5| 7| 7| 7| 7| 7| 7| 6| 7| 7| 7| 7| 7| 6| 7| 7| 7| 7| 7| | DAY ON TEST | 5| 2| 2| 0| 8| 3| 7| 3| 2| 3| 3| 3| 2| 9| 2| 2| 3| 3| 2| 4| 2| 3| 2| 2| 2| | | 2| 9| 9| 1| 3| 0| 9| 0| 9| 0| 0| 0| 9| 8| 9| 9| 0| 0| 9| 5| 9| 0| 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 | B6C3F1 MICE 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| 4| A | 504 | 7| 7| 7| 7| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 0| L | MG/KG | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| | _____________________________________________________________________________________________________________________|____________| URINARY SYSTEM - cont | | | Metaplasia, Osseous | 1 1 | 3 1.0| Mineralization | | 1 1.0| Nephropathy | 1 2 1 1 1 1 1 1 1 1| 27 1.2| Renal Tubule, Vacuolization | | | Cytoplasmic | 3 | 1 3.0| |__________________________________________________________________________|____________| Urinary Bladder | + + M + + + + + + + + + + + + + + + + A + + + + +| 46 | __________________________________________________________________________________________________________________________________ * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 43 NTP Experiment-Test: 88122-07 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC ELMIRON Date: 04/23/01 Route: GAVAGE Time: 15:23:02 _____________________________________________________________________________________________________________________ | 7| 7| 4| 7| 7| 7| 7| 7| 7| 7| 7| 6| 7| 7| 5| 7| 6| 7| 7| 4| 7| 6| 7| 7| 7| DAY ON TEST | 3| 3| 2| 3| 3| 3| 3| 3| 3| 3| 3| 0| 3| 3| 9| 3| 9| 3| 3| 7| 3| 4| 3| 3| 3| | 1| 1| 0| 0| 1| 0| 1| 0| 1| 1| 1| 6| 0| 1| 0| 0| 0| 1| 0| 7| 1| 6| 1| 1| 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| B6C3F1 MICE 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 | 0| 0| 0| 0| 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 2| | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| __________________________________________|__________________________________________________________________________| ALIMENTARY SYSTEM | | |__________________________________________________________________________| Esophagus | + + + + + + + + + + + + + + + + + + + + + + + + +| Hyperplasia, Squamous | 3 | Inflammation, Chronic Active | 2 | |__________________________________________________________________________| Gallbladder | + + A + + + + + + + + + + + M + M M M + + + + + +| Degeneration, Hyaline | 3 | Inflammation, Chronic Active | 2 | |__________________________________________________________________________| Intestine Large, Colon | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Intestine Large, Rectum | + + + + + + + + + + + + + + + + + + + + + + + I +| |__________________________________________________________________________| Intestine Large, Cecum | + + + + + + + + + + + + + + + + A + + + + + + + +| |__________________________________________________________________________| Intestine Small, Duodenum | + + A + + + + + + + + + + + + + A + + + + + + + +| |__________________________________________________________________________| Intestine Small, Jejunum | + + A + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Intestine Small, Ileum | + + A + + + + + + + + + + + + + A + + + + + + + +| |__________________________________________________________________________| Liver | + + + + + + + + + + + + + + + + + + + + + + + + +| Basophilic Focus | X X X X X| Clear Cell Focus | X X X X X X X X X| Eosinophilic Focus | X X X X X X X X X | Fatty Change | 1 2 1 1 1 1 | Inflammation, Chronic | 1 1 1 1 1 1| Mineralization | 2 | Necrosis | 3 | Tension Lipidosis | | Vacuolization Cytoplasmic, Focal | | Bile Duct, Cyst | | |__________________________________________________________________________| Mesentery | + + + + + | Mineralization | 2 | Fat, Necrosis | 2 2 2 3 3 | |__________________________________________________________________________| Pancreas | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________|__________________________________________________________________________| Page 44 NTP Experiment-Test: 88122-07 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC ELMIRON Date: 04/23/01 Route: GAVAGE Time: 15:23:02 _____________________________________________________________________________________________________________________ | 7| 7| 4| 7| 7| 7| 7| 7| 7| 7| 7| 6| 7| 7| 5| 7| 6| 7| 7| 4| 7| 6| 7| 7| 7| DAY ON TEST | 3| 3| 2| 3| 3| 3| 3| 3| 3| 3| 3| 0| 3| 3| 9| 3| 9| 3| 3| 7| 3| 4| 3| 3| 3| | 1| 1| 0| 0| 1| 0| 1| 0| 1| 1| 1| 6| 0| 1| 0| 0| 0| 1| 0| 7| 1| 6| 1| 1| 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| B6C3F1 MICE 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 | 0| 0| 0| 0| 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 2| | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| __________________________________________|__________________________________________________________________________| ALIMENTARY SYSTEM - cont | | |__________________________________________________________________________| Salivary Glands | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Stomach, Forestomach | + + A + + + + + + + + + + + + + + + + + + + + + +| Hyperplasia, Squamous | 3 1 2 2| Inflammation, Acute | | |__________________________________________________________________________| Stomach, Glandular | + + A + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Tooth | + + + + + + + + + + + + + + +| Inflammation, Chronic Active | 3 3 | Malformation | 3 1 1 2 2 2 1 2 2 1 X 2 1 3| _____________________________________________________________________________________________________________________| CARDIOVASCULAR SYSTEM | | |__________________________________________________________________________| Heart | + + + + + + + + + + + + + + + + + + + + + + + + +| Cardiomyopathy | 1 | Mineralization | | _____________________________________________________________________________________________________________________| ENDOCRINE SYSTEM | | |__________________________________________________________________________| Adrenal Cortex | + + + + + + + + + + + + + + + + + + + + + + + + +| Hyperplasia | 2 2 2 | Hypertrophy | 3 2 1 1 2 1 3 4 2 2 2 2 2 2 1 2 1| |__________________________________________________________________________| Adrenal Medulla | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Islets, Pancreatic | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Parathyroid Gland | + + + + + + M + + + + + + + + M + + + + + + + M +| |__________________________________________________________________________| Pituitary Gland | + + M + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Thyroid Gland | I + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| GENERAL BODY SYSTEM | | None | | __________________________________________|__________________________________________________________________________| Page 45 NTP Experiment-Test: 88122-07 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC ELMIRON Date: 04/23/01 Route: GAVAGE Time: 15:23:02 _____________________________________________________________________________________________________________________ | 7| 7| 4| 7| 7| 7| 7| 7| 7| 7| 7| 6| 7| 7| 5| 7| 6| 7| 7| 4| 7| 6| 7| 7| 7| DAY ON TEST | 3| 3| 2| 3| 3| 3| 3| 3| 3| 3| 3| 0| 3| 3| 9| 3| 9| 3| 3| 7| 3| 4| 3| 3| 3| | 1| 1| 0| 0| 1| 0| 1| 0| 1| 1| 1| 6| 0| 1| 0| 0| 0| 1| 0| 7| 1| 6| 1| 1| 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| B6C3F1 MICE 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 | 0| 0| 0| 0| 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 2| | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| __________________________________________|__________________________________________________________________________| GENITAL SYSTEM | | |__________________________________________________________________________| Coagulating Gland | | |__________________________________________________________________________| Epididymis | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Preputial Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| Ectasia | 3 | Inflammation, Chronic Active | | |__________________________________________________________________________| Prostate | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Seminal Vesicle | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Testes | + + + + + + + + + + + + + + + + + + + + + + + + +| Atrophy | 3 | _____________________________________________________________________________________________________________________| HEMATOPOIETIC SYSTEM | | |__________________________________________________________________________| Bone Marrow | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Lymph Node | + | |__________________________________________________________________________| Lymph Node, Mandibular | M + M + M + M M + + + + M M + M + + + M + + + + M| |__________________________________________________________________________| Lymph Node, Mesenteric | + + + + + + + + + + + + + + + + + + + + + + + + M| Angiectasis | 2 3 | |__________________________________________________________________________| Spleen | + + + + + + + + + + + + + + + + A + + + + + + + +| Hematopoietic Cell Proliferation | 2 2 3 | |__________________________________________________________________________| Thymus | + + + + + + M + + + + + + + + + M + + + + + + + +| _____________________________________________________________________________________________________________________| INTEGUMENTARY SYSTEM | | |__________________________________________________________________________| Mammary Gland | 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| |__________________________________________________________________________| Skin | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________|__________________________________________________________________________| Page 46 NTP Experiment-Test: 88122-07 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC ELMIRON Date: 04/23/01 Route: GAVAGE Time: 15:23:02 _____________________________________________________________________________________________________________________ | 7| 7| 4| 7| 7| 7| 7| 7| 7| 7| 7| 6| 7| 7| 5| 7| 6| 7| 7| 4| 7| 6| 7| 7| 7| DAY ON TEST | 3| 3| 2| 3| 3| 3| 3| 3| 3| 3| 3| 0| 3| 3| 9| 3| 9| 3| 3| 7| 3| 4| 3| 3| 3| | 1| 1| 0| 0| 1| 0| 1| 0| 1| 1| 1| 6| 0| 1| 0| 0| 0| 1| 0| 7| 1| 6| 1| 1| 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| B6C3F1 MICE 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 | 0| 0| 0| 0| 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 2| | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| __________________________________________|__________________________________________________________________________| MUSCULOSKELETAL SYSTEM | | |__________________________________________________________________________| Bone | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| NERVOUS SYSTEM | | |__________________________________________________________________________| Brain | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| RESPIRATORY SYSTEM | | |__________________________________________________________________________| Lung | + + + + + + + + + + + + + + + + + + + + + + + + +| Inflammation, Chronic Active | 3 | Alveolar Epithelium, Hyperplasia | 3 1 | Alveolus, Infiltration Cellular, | | Histiocyte | | |__________________________________________________________________________| Nose | + + + + + + + + + + + + + + + + + + + + + + + + +| Inflammation, Suppurative | 2| Polyp, Inflammatory | | |__________________________________________________________________________| Trachea | + + + + + + + + + + + + + + + + + + + + + + + + +| Mineralization | 1 | _____________________________________________________________________________________________________________________| SPECIAL SENSES SYSTEM | | |__________________________________________________________________________| Harderian Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| Hyperplasia | | _____________________________________________________________________________________________________________________| URINARY SYSTEM | | |__________________________________________________________________________| Kidney | + + + + + + + + + + + + + + + + + + + + + + + + +| Infarct | 2 | Metaplasia, Osseous | 2 | Mineralization | 1 | Nephropathy | 1 2 2 1 1 1 1 1 2 1 1 3 1 1 2 3 1 1 1 2 1| |__________________________________________________________________________| Urinary Bladder | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________|__________________________________________________________________________ Page 47 NTP Experiment-Test: 88122-07 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC ELMIRON Date: 04/23/01 Route: GAVAGE Time: 15:23:02 __________________________________________________________________________________________________________________________________ | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 6| 7| 5| 7| 7| 7| 7| 7| 7| 6| 6| 7| 7| 7| 7| | DAY ON TEST | 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 6| 3| 9| 3| 3| 3| 3| 3| 0| 3| 2| 3| 3| 3| 3| | | 0| 1| 1| 0| 1| 1| 1| 1| 1| 1| 4| 0| 9| 0| 1| 0| 1| 0| 2| 2| 0| 0| 1| 1| 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 | B6C3F1 MICE 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 | 2| 2| 2| 2| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 5| L | | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| | _____________________________________________________________________________________________________________________|____________| ALIMENTARY SYSTEM | | | |__________________________________________________________________________|____________| Esophagus | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Hyperplasia, Squamous | | 1 3.0| Inflammation, Chronic Active | | 1 2.0| |__________________________________________________________________________|____________| Gallbladder | + M + + + + + + + M + + A + + + + + + M M + + + +| 40 | Degeneration, Hyaline | 2 4| 3 3.0| Inflammation, Chronic Active | | 1 2.0| |__________________________________________________________________________|____________| Intestine Large, Colon | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Intestine Large, Rectum | + + + + + + + + + + + + + + + + + + + + + + + + +| 49 | |__________________________________________________________________________|____________| Intestine Large, Cecum | + + + + + + + + + + + + + + + + + + + + + + + + +| 49 | |__________________________________________________________________________|____________| Intestine Small, Duodenum | + + + + + + + + + + + + A + + + + + + + + + + + +| 47 | |__________________________________________________________________________|____________| Intestine Small, Jejunum | + + + + + + + + + + A + A + + + + + + + + + + + +| 47 | |__________________________________________________________________________|____________| Intestine Small, Ileum | + + + + + + + + + + A + A + + + + + + + + + + + +| 46 | |__________________________________________________________________________|____________| Liver | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Basophilic Focus | X X X X X X X X X | 14 | Clear Cell Focus | X X X X X X X X X X X X | 21 | Eosinophilic Focus | X X X X | 13 | Fatty Change | 1 1 1 | 9 1.1| Inflammation, Chronic | 1 1 1 1 2 | 11 1.1| Mineralization | | 1 2.0| Necrosis | 1 | 2 2.0| Tension Lipidosis | X X | 2 | Vacuolization Cytoplasmic, Focal | 2 | 1 2.0| Bile Duct, Cyst | 1 | 1 1.0| |__________________________________________________________________________|____________| Mesentery | + + + + + | 10 | _____________________________________________________________________________________________________________________|____________| * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 48 NTP Experiment-Test: 88122-07 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC ELMIRON Date: 04/23/01 Route: GAVAGE Time: 15:23:02 __________________________________________________________________________________________________________________________________ | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 6| 7| 5| 7| 7| 7| 7| 7| 7| 6| 6| 7| 7| 7| 7| | DAY ON TEST | 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 6| 3| 9| 3| 3| 3| 3| 3| 0| 3| 2| 3| 3| 3| 3| | | 0| 1| 1| 0| 1| 1| 1| 1| 1| 1| 4| 0| 9| 0| 1| 0| 1| 0| 2| 2| 0| 0| 1| 1| 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 | B6C3F1 MICE 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 | 2| 2| 2| 2| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 5| L | | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| | _____________________________________________________________________________________________________________________|____________| ALIMENTARY SYSTEM - cont | | | Mineralization | | 1 2.0| Fat, Necrosis | 2 2 2 2 2 | 10 2.2| |__________________________________________________________________________|____________| Pancreas | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Salivary Glands | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Stomach, Forestomach | + + + + + + + + + + + + + + + + + + + + + + + + +| 49 | Hyperplasia, Squamous | 3 1 | 6 2.0| Inflammation, Acute | 3 | 1 3.0| |__________________________________________________________________________|____________| Stomach, Glandular | + + + + + + + + + + + + + + + + + + + + + + + + +| 49 | |__________________________________________________________________________|____________| Tooth | + + + + + + + + + + + + + + + + + + | 33 | Inflammation, Chronic Active | 3 3 2 1 | 6 2.5| Malformation | 2 2 1 1 1 2 1 3 1 2 1 1 4 3 1 | 29 1.8| _____________________________________________________________________________________________________________________| | CARDIOVASCULAR SYSTEM | | | |__________________________________________________________________________|____________| Heart | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Cardiomyopathy | 1 1 | 3 1.0| Mineralization | 1 | 1 1.0| _____________________________________________________________________________________________________________________| | ENDOCRINE SYSTEM | | | |__________________________________________________________________________|____________| Adrenal Cortex | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Hyperplasia | 1 2 | 5 1.8| Hypertrophy | 2 3 2 2 1 1 2 1 1 1 | 27 1.8| |__________________________________________________________________________|____________| Adrenal Medulla | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Islets, Pancreatic | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Parathyroid Gland | + + M + + + + + + + + + + + + + + + M + + + M + +| 44 | _____________________________________________________________________________________________________________________|____________| * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 49 NTP Experiment-Test: 88122-07 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC ELMIRON Date: 04/23/01 Route: GAVAGE Time: 15:23:02 __________________________________________________________________________________________________________________________________ | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 6| 7| 5| 7| 7| 7| 7| 7| 7| 6| 6| 7| 7| 7| 7| | DAY ON TEST | 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 6| 3| 9| 3| 3| 3| 3| 3| 0| 3| 2| 3| 3| 3| 3| | | 0| 1| 1| 0| 1| 1| 1| 1| 1| 1| 4| 0| 9| 0| 1| 0| 1| 0| 2| 2| 0| 0| 1| 1| 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 | B6C3F1 MICE 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 | 2| 2| 2| 2| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 5| L | | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| | _____________________________________________________________________________________________________________________|____________| ENDOCRINE SYSTEM - cont | | | |__________________________________________________________________________|____________| Pituitary Gland | + + + + + + + + M + + + + + + M + + + + + + + + +| 47 | |__________________________________________________________________________|____________| Thyroid Gland | + + + + + + + + + + + + + + + + + + M + + + + + +| 48 | _____________________________________________________________________________________________________________________| | GENERAL BODY SYSTEM | | | None | | | _____________________________________________________________________________________________________________________| | GENITAL SYSTEM | | | |__________________________________________________________________________|____________| Coagulating Gland | + | 1 | |__________________________________________________________________________|____________| Epididymis | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Preputial Gland | M + + + + + + + + + + + + + + + + + + + + + + + +| 49 | Ectasia | 4 3 | 3 3.3| Inflammation, Chronic Active | 1 | 1 1.0| |__________________________________________________________________________|____________| Prostate | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Seminal Vesicle | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Testes | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Atrophy | | 1 3.0| _____________________________________________________________________________________________________________________| | HEMATOPOIETIC SYSTEM | | | |__________________________________________________________________________|____________| Bone Marrow | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Lymph Node | | 1 | |__________________________________________________________________________|____________| Lymph Node, Mandibular | + M + + + M + + M M M M + + + M M M + + + M M + M| 28 | |__________________________________________________________________________|____________| Lymph Node, Mesenteric | + + M + + + + + + + + + + + + + + + + + + + + + +| 48 | _____________________________________________________________________________________________________________________|____________| * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 50 NTP Experiment-Test: 88122-07 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC ELMIRON Date: 04/23/01 Route: GAVAGE Time: 15:23:02 __________________________________________________________________________________________________________________________________ | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 6| 7| 5| 7| 7| 7| 7| 7| 7| 6| 6| 7| 7| 7| 7| | DAY ON TEST | 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 6| 3| 9| 3| 3| 3| 3| 3| 0| 3| 2| 3| 3| 3| 3| | | 0| 1| 1| 0| 1| 1| 1| 1| 1| 1| 4| 0| 9| 0| 1| 0| 1| 0| 2| 2| 0| 0| 1| 1| 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 | B6C3F1 MICE 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 | 2| 2| 2| 2| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 5| L | | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| | _____________________________________________________________________________________________________________________|____________| HEMATOPOIETIC SYSTEM - cont | | | Angiectasis | 1 | 3 2.0| |__________________________________________________________________________|____________| Spleen | + + + + + + + + + + + + + + + + + + + + + + + + +| 49 | Hematopoietic Cell Proliferation | 2 2 2 2 2 2 1 | 10 2.0| |__________________________________________________________________________|____________| Thymus | + + + + + + + + + + + M M + + M M + M M + M + + M| 40 | _____________________________________________________________________________________________________________________| | INTEGUMENTARY SYSTEM | | | |__________________________________________________________________________|____________| Mammary Gland | M M M M M M M M M M M M M M M M M M M M M M + M M| 1 | |__________________________________________________________________________|____________| Skin | + + + + I + + + + + + + + + + + + + + + + + + + +| 49 | _____________________________________________________________________________________________________________________| | MUSCULOSKELETAL SYSTEM | | | |__________________________________________________________________________|____________| Bone | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | _____________________________________________________________________________________________________________________| | NERVOUS SYSTEM | | | |__________________________________________________________________________|____________| Brain | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | _____________________________________________________________________________________________________________________| | RESPIRATORY SYSTEM | | | |__________________________________________________________________________|____________| Lung | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Inflammation, Chronic Active | | 1 3.0| Alveolar Epithelium, Hyperplasia | 3 | 3 2.3| Alveolus, Infiltration Cellular, | | | Histiocyte | 2 | 1 2.0| |__________________________________________________________________________|____________| Nose | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Inflammation, Suppurative | 3 3 2 1 | 5 2.2| Polyp, Inflammatory | 3 | 1 3.0| |__________________________________________________________________________|____________| Trachea | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | _____________________________________________________________________________________________________________________|____________| * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 51 NTP Experiment-Test: 88122-07 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC ELMIRON Date: 04/23/01 Route: GAVAGE Time: 15:23:02 __________________________________________________________________________________________________________________________________ | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 6| 7| 5| 7| 7| 7| 7| 7| 7| 6| 6| 7| 7| 7| 7| | DAY ON TEST | 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 6| 3| 9| 3| 3| 3| 3| 3| 0| 3| 2| 3| 3| 3| 3| | | 0| 1| 1| 0| 1| 1| 1| 1| 1| 1| 4| 0| 9| 0| 1| 0| 1| 0| 2| 2| 0| 0| 1| 1| 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 | B6C3F1 MICE 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 | 2| 2| 2| 2| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 5| L | | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| | _____________________________________________________________________________________________________________________|____________| RESPIRATORY SYSTEM - cont | | | Mineralization | | 1 1.0| _____________________________________________________________________________________________________________________| | SPECIAL SENSES SYSTEM | | | |__________________________________________________________________________|____________| Harderian Gland | + + + + + + + + + + + + + + + + + + + + + + + +| 49 | Hyperplasia | 2 | 1 2.0| _____________________________________________________________________________________________________________________| | URINARY SYSTEM | | | |__________________________________________________________________________|____________| Kidney | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Infarct | | 1 2.0| Metaplasia, Osseous | | 1 2.0| Mineralization | | 1 1.0| Nephropathy | 4 1 1 2 1 3 2 1 1 2 3 1 1 3 1 2 1 4 1 1 1 3| 43 1.6| |__________________________________________________________________________|____________| Urinary Bladder | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | __________________________________________________________________________________________________________________________________ * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 52 NTP Experiment-Test: 88122-07 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC ELMIRON Date: 04/23/01 Route: GAVAGE Time: 15:23:02 _____________________________________________________________________________________________________________________ | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 5| 7| 3| 7| 7| DAY ON TEST | 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 2| 3| 3| 3| 3| 3| 3| 3| 0| 3| 4| 3| 3| | 0| 0| 0| 1| 1| 1| 1| 1| 0| 0| 0| 0| 8| 0| 0| 1| 1| 1| 1| 0| 8| 1| 6| 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| 0| B6C3F1 MICE 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| 56 MG/KG | 5| 5| 5| 5| 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 7| | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| __________________________________________|__________________________________________________________________________| ALIMENTARY SYSTEM | | |__________________________________________________________________________| Esophagus | + + + + + + + + + + + + + + + + + + + + + + + + +| Inflammation, Acute | | |__________________________________________________________________________| Gallbladder | + + + + + + + + + + + + A M + + + + + + + + A + +| Cyst | 1 | Degeneration, Hyaline | 4 | |__________________________________________________________________________| Intestine Large, Colon | + + + + + + + + + + + + A + + + + + + + + + A + +| |__________________________________________________________________________| Intestine Large, Rectum | + + + + + + + + + + + + A + + + + + + + + + A + +| |__________________________________________________________________________| Intestine Large, Cecum | + + + + + + + + + + + + A + + + + + + + + + A + +| |__________________________________________________________________________| Intestine Small, Duodenum | + + + + + + + + + + + + A + + + + + + + + + A + +| |__________________________________________________________________________| Intestine Small, Jejunum | + + + + + + + + + + + + + + + + + + + + + + A + +| Mineralization | 3 | Necrosis | 3 | |__________________________________________________________________________| Intestine Small, Ileum | + + + + + + + + + + + + A + + + + + + + + + A + +| |__________________________________________________________________________| Liver | + + + + + + + + + + + + + + + + + + + + + + + + +| Basophilic Focus | X X X X X X | Clear Cell Focus | X X X X X X X X X X X X X X X X| Eosinophilic Focus | X X X X X X X X| Fatty Change | 1 1 1 1 1 | Hematopoietic Cell Proliferation | | Inflammation, Chronic | 1 1 1 1 1 1 | Necrosis | 4 | Tension Lipidosis | | Centrilobular, Degeneration | 3 | |__________________________________________________________________________| Mesentery | + + + | Fat, Necrosis | 2 2 3 | |__________________________________________________________________________| Pancreas | + + + + + + + + + + + + + + + + + + + + + + + + +| Atrophy | | __________________________________________|__________________________________________________________________________| Page 53 NTP Experiment-Test: 88122-07 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC ELMIRON Date: 04/23/01 Route: GAVAGE Time: 15:23:02 _____________________________________________________________________________________________________________________ | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 5| 7| 3| 7| 7| DAY ON TEST | 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 2| 3| 3| 3| 3| 3| 3| 3| 0| 3| 4| 3| 3| | 0| 0| 0| 1| 1| 1| 1| 1| 0| 0| 0| 0| 8| 0| 0| 1| 1| 1| 1| 0| 8| 1| 6| 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| 0| B6C3F1 MICE 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| 56 MG/KG | 5| 5| 5| 5| 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 7| | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| __________________________________________|__________________________________________________________________________| ALIMENTARY SYSTEM - cont | | Artery, Inflammation | 4 | |__________________________________________________________________________| Salivary Glands | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Stomach, Forestomach | + + + + + + + + + + + + + + + + + + + + + + + + +| Ulcer | | |__________________________________________________________________________| Stomach, Glandular | + + + + + + + + + + + + + + + + + + + + + + A + +| Hyperplasia | | |__________________________________________________________________________| Tooth | + + + + + + + + + + + + + + + | Inflammation, Chronic Active | 2 2 | Malformation | 1 2 1 1 1 2 1 2 1 1 2 2 2 1 | _____________________________________________________________________________________________________________________| CARDIOVASCULAR SYSTEM | | |__________________________________________________________________________| Blood Vessel | | Angiectasis | | Thrombosis | | |__________________________________________________________________________| Heart | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| ENDOCRINE SYSTEM | | |__________________________________________________________________________| Adrenal Cortex | + + + + + + + + + + + + + + + + + + + + + + + + +| Hyperplasia | 1 2| Hypertrophy | 1 2 1 1 1 1 2 1 1 1 1 1 1 2 2 1 | |__________________________________________________________________________| Adrenal Medulla | + + + + + + + + + + + + + + + + + + + + + + + + +| Hyperplasia | 3 | |__________________________________________________________________________| Islets, Pancreatic | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Parathyroid Gland | + + M + + M + + + + + + A M + + + + + + + + + + +| |__________________________________________________________________________| Pituitary Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Thyroid Gland | + + + + + + + + + + + + A + + + + + + + + + + + +| __________________________________________|__________________________________________________________________________| Page 54 NTP Experiment-Test: 88122-07 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC ELMIRON Date: 04/23/01 Route: GAVAGE Time: 15:23:02 _____________________________________________________________________________________________________________________ | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 5| 7| 3| 7| 7| DAY ON TEST | 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 2| 3| 3| 3| 3| 3| 3| 3| 0| 3| 4| 3| 3| | 0| 0| 0| 1| 1| 1| 1| 1| 0| 0| 0| 0| 8| 0| 0| 1| 1| 1| 1| 0| 8| 1| 6| 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| 0| B6C3F1 MICE 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| 56 MG/KG | 5| 5| 5| 5| 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 7| | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| __________________________________________|__________________________________________________________________________| GENERAL BODY SYSTEM | | |__________________________________________________________________________| Peritoneum | | _____________________________________________________________________________________________________________________| GENITAL SYSTEM | | |__________________________________________________________________________| Epididymis | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Preputial Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| Ectasia | | Inflammation, Chronic Active | 2 2 | |__________________________________________________________________________| Prostate | + + + + + + + + + + + + + + + + + + + + + + + + +| Inflammation, Suppurative | | |__________________________________________________________________________| Seminal Vesicle | + + + + + + + + + + + + + + + + + + + + + + + + +| Congestion | | Inflammation, Suppurative | | |__________________________________________________________________________| Testes | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| HEMATOPOIETIC SYSTEM | | |__________________________________________________________________________| Bone Marrow | + + + + + + + + + + + + + + + + + + + + + + + + +| Angiectasis | 2 | |__________________________________________________________________________| Lymph Node | | |__________________________________________________________________________| Lymph Node, Mandibular | + M M + + + M + M + M M M + M + M + M M M + M + +| |__________________________________________________________________________| Lymph Node, Mesenteric | + + + + + + + M + + + + + + + + + + + + + + + + M| Infiltration Cellular, Histiocyte | 2 1 1 1 1 1 1 | |__________________________________________________________________________| Spleen | + + + + + + + + + + + + + + + + + + + + + + + + +| Hematopoietic Cell Proliferation | 1 3 1 2 | Infiltration Cellular, Histiocyte | | |__________________________________________________________________________| Thymus | + M + + + + M M + + + + + + I + + + + M + + + + +| __________________________________________|__________________________________________________________________________| Page 55 NTP Experiment-Test: 88122-07 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC ELMIRON Date: 04/23/01 Route: GAVAGE Time: 15:23:02 _____________________________________________________________________________________________________________________ | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 5| 7| 3| 7| 7| DAY ON TEST | 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 2| 3| 3| 3| 3| 3| 3| 3| 0| 3| 4| 3| 3| | 0| 0| 0| 1| 1| 1| 1| 1| 0| 0| 0| 0| 8| 0| 0| 1| 1| 1| 1| 0| 8| 1| 6| 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| 0| B6C3F1 MICE 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| 56 MG/KG | 5| 5| 5| 5| 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 7| | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| __________________________________________|__________________________________________________________________________| INTEGUMENTARY SYSTEM | | |__________________________________________________________________________| Mammary Gland | M M M M M M M M M M M M M M M M M M M M + M M M M| |__________________________________________________________________________| Skin | + + + + + + + + + + + + + + + + + + + + + + + + +| Subcutaneous Tissue, Edema | 3 | _____________________________________________________________________________________________________________________| MUSCULOSKELETAL SYSTEM | | |__________________________________________________________________________| Bone | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Skeletal Muscle | | _____________________________________________________________________________________________________________________| NERVOUS SYSTEM | | |__________________________________________________________________________| Brain | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| RESPIRATORY SYSTEM | | |__________________________________________________________________________| Lung | + + + + + + + + + + + + + + + + + + + + + + + + +| Hemorrhage | | Alveolar Epithelium, Hyperplasia | 1 3 2 2| Mediastinum, Inflammation, Acute | | |__________________________________________________________________________| Nose | + + + + + + + + + + + + + + + + + + + + + + + + +| Olfactory Epithelium, Atrophy | | Olfactory Epithelium, Metaplasia | 2 1 | |__________________________________________________________________________| Trachea | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| SPECIAL SENSES SYSTEM | | |__________________________________________________________________________| Eye | + | Cornea, Inflammation, Chronic | 3 | |__________________________________________________________________________| Harderian Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| Atrophy | 2 | Hyperplasia | 3 | Inflammation, Acute | | __________________________________________|__________________________________________________________________________| Page 56 NTP Experiment-Test: 88122-07 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC ELMIRON Date: 04/23/01 Route: GAVAGE Time: 15:23:02 _____________________________________________________________________________________________________________________ | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 5| 7| 3| 7| 7| DAY ON TEST | 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 2| 3| 3| 3| 3| 3| 3| 3| 0| 3| 4| 3| 3| | 0| 0| 0| 1| 1| 1| 1| 1| 0| 0| 0| 0| 8| 0| 0| 1| 1| 1| 1| 0| 8| 1| 6| 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| 0| B6C3F1 MICE 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| 56 MG/KG | 5| 5| 5| 5| 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 7| | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| __________________________________________|__________________________________________________________________________| URINARY SYSTEM | | |__________________________________________________________________________| Kidney | + + + + + + + + + + + + + + + + + + + + + + + + +| Infarct | 2 2 3 | Inflammation, Suppurative | 3 3 | Metaplasia, Osseous | | Nephropathy | 1 1 1 1 1 1 1 2 1 2 1 2 1 3 2 2 2 1 1 2| Papilla, Necrosis | | |__________________________________________________________________________| Urinary Bladder | + + + + + + + + + + + + + + + + + + + + + + A + +| Transitional Epithelium, Hyperplasia | | __________________________________________|__________________________________________________________________________ Page 57 NTP Experiment-Test: 88122-07 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC ELMIRON Date: 04/23/01 Route: GAVAGE Time: 15:23:02 __________________________________________________________________________________________________________________________________ | 7| 0| 7| 7| 4| 7| 7| 6| 7| 7| 5| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 3| 5| 7| | DAY ON TEST | 3| 1| 3| 3| 5| 3| 3| 8| 3| 3| 0| 3| 3| 3| 3| 3| 3| 3| 3| 3| 0| 3| 1| 0| 3| | | 1| 1| 1| 1| 5| 0| 0| 8| 1| 0| 8| 1| 1| 0| 0| 0| 0| 1| 0| 0| 7| 0| 1| 8| 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 | B6C3F1 MICE 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| 1| A | 56 MG/KG | 7| 7| 7| 7| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 0| L | | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| | _____________________________________________________________________________________________________________________|____________| ALIMENTARY SYSTEM | | | |__________________________________________________________________________|____________| Esophagus | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Inflammation, Acute | 2 | 1 2.0| |__________________________________________________________________________|____________| Gallbladder | + + + + + + M + I + + + + M + M + I + I A M + A +| 38 | Cyst | | 1 1.0| Degeneration, Hyaline | | 1 4.0| |__________________________________________________________________________|____________| Intestine Large, Colon | + + + + + + + + + + + + + + + + + + + + A + + + +| 47 | |__________________________________________________________________________|____________| Intestine Large, Rectum | + + + + + + + + + + + + + + + + + + + + A + + + +| 47 | |__________________________________________________________________________|____________| Intestine Large, Cecum | + + + + + + + + + + + + + + + + + + + + A + + + +| 47 | |__________________________________________________________________________|____________| Intestine Small, Duodenum | + + + + + + + + + + + + + + + + + + + + A + + + +| 47 | |__________________________________________________________________________|____________| Intestine Small, Jejunum | + + + + + + + + + + + + + + + + + + + + A + + A +| 47 | Mineralization | | 1 3.0| Necrosis | | 1 3.0| |__________________________________________________________________________|____________| Intestine Small, Ileum | + + + + + + + + + + + + + + + + + + + + A + + + +| 47 | |__________________________________________________________________________|____________| Liver | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Basophilic Focus | X X X X | 10 | Clear Cell Focus | X X X X X X X | 23 | Eosinophilic Focus | X X X | 11 | Fatty Change | 1 1 1 1 1 1 2 | 12 1.1| Hematopoietic Cell Proliferation | 1 | 1 1.0| Inflammation, Chronic | 1 1 1 1 1 1 1 2 1| 15 1.1| Necrosis | 2 | 2 3.0| Tension Lipidosis | X X | 2 | Centrilobular, Degeneration | | 1 3.0| |__________________________________________________________________________|____________| Mesentery | + | 4 | _____________________________________________________________________________________________________________________|____________| * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 58 NTP Experiment-Test: 88122-07 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC ELMIRON Date: 04/23/01 Route: GAVAGE Time: 15:23:02 __________________________________________________________________________________________________________________________________ | 7| 0| 7| 7| 4| 7| 7| 6| 7| 7| 5| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 3| 5| 7| | DAY ON TEST | 3| 1| 3| 3| 5| 3| 3| 8| 3| 3| 0| 3| 3| 3| 3| 3| 3| 3| 3| 3| 0| 3| 1| 0| 3| | | 1| 1| 1| 1| 5| 0| 0| 8| 1| 0| 8| 1| 1| 0| 0| 0| 0| 1| 0| 0| 7| 0| 1| 8| 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 | B6C3F1 MICE 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| 1| A | 56 MG/KG | 7| 7| 7| 7| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 0| L | | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| | _____________________________________________________________________________________________________________________|____________| ALIMENTARY SYSTEM - cont | | | Fat, Necrosis | | 3 2.3| |__________________________________________________________________________|____________| Pancreas | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Atrophy | 3 | 1 3.0| Artery, Inflammation | | 1 4.0| |__________________________________________________________________________|____________| Salivary Glands | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Stomach, Forestomach | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Ulcer | 2 | 1 2.0| |__________________________________________________________________________|____________| Stomach, Glandular | + + + + + + + + + + + + + + + + + + + + + + + + +| 49 | Hyperplasia | 4 | 1 4.0| |__________________________________________________________________________|____________| Tooth | + + + + + + + + + + + +| 27 | Inflammation, Chronic Active | 2 2 2 3 | 6 2.2| Malformation | 3 2 2 1 2 2 1 1| 22 1.5| _____________________________________________________________________________________________________________________| | CARDIOVASCULAR SYSTEM | | | |__________________________________________________________________________|____________| Blood Vessel | + | 1 | Angiectasis | 3 | 1 3.0| Thrombosis | 2 | 1 2.0| |__________________________________________________________________________|____________| Heart | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | _____________________________________________________________________________________________________________________| | ENDOCRINE SYSTEM | | | |__________________________________________________________________________|____________| Adrenal Cortex | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Hyperplasia | 2 2 2 1 2 2 | 8 1.8| Hypertrophy | 1 2 1 1 1 1 1 4 2 1 2| 27 1.4| |__________________________________________________________________________|____________| Adrenal Medulla | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Hyperplasia | 3 2 | 3 2.7| _____________________________________________________________________________________________________________________|____________| * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 59 NTP Experiment-Test: 88122-07 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC ELMIRON Date: 04/23/01 Route: GAVAGE Time: 15:23:02 __________________________________________________________________________________________________________________________________ | 7| 0| 7| 7| 4| 7| 7| 6| 7| 7| 5| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 3| 5| 7| | DAY ON TEST | 3| 1| 3| 3| 5| 3| 3| 8| 3| 3| 0| 3| 3| 3| 3| 3| 3| 3| 3| 3| 0| 3| 1| 0| 3| | | 1| 1| 1| 1| 5| 0| 0| 8| 1| 0| 8| 1| 1| 0| 0| 0| 0| 1| 0| 0| 7| 0| 1| 8| 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 | B6C3F1 MICE 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| 1| A | 56 MG/KG | 7| 7| 7| 7| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 0| L | | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| | _____________________________________________________________________________________________________________________|____________| ENDOCRINE SYSTEM - cont | | | |__________________________________________________________________________|____________| Islets, Pancreatic | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Parathyroid Gland | + + + + + M + + + + + + M + + + + + + M + + + + M| 42 | |__________________________________________________________________________|____________| Pituitary Gland | I + + + + + + + + + + + + + + I + + + + + + + + +| 48 | |__________________________________________________________________________|____________| Thyroid Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| 49 | _____________________________________________________________________________________________________________________| | GENERAL BODY SYSTEM | | | |__________________________________________________________________________|____________| Peritoneum | + | 1 | _____________________________________________________________________________________________________________________| | GENITAL SYSTEM | | | |__________________________________________________________________________|____________| Epididymis | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Preputial Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Ectasia | 2 2 3 | 3 2.3| Inflammation, Chronic Active | | 2 2.0| |__________________________________________________________________________|____________| Prostate | + + + + + + + + + + + + + + + + + I + + + + + + +| 49 | Inflammation, Suppurative | 4 | 1 4.0| |__________________________________________________________________________|____________| Seminal Vesicle | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Congestion | 4 | 1 4.0| Inflammation, Suppurative | 3 | 1 3.0| |__________________________________________________________________________|____________| Testes | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | _____________________________________________________________________________________________________________________| | HEMATOPOIETIC SYSTEM | | | |__________________________________________________________________________|____________| Bone Marrow | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Angiectasis | | 1 2.0| _____________________________________________________________________________________________________________________|____________| * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 60 NTP Experiment-Test: 88122-07 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC ELMIRON Date: 04/23/01 Route: GAVAGE Time: 15:23:02 __________________________________________________________________________________________________________________________________ | 7| 0| 7| 7| 4| 7| 7| 6| 7| 7| 5| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 3| 5| 7| | DAY ON TEST | 3| 1| 3| 3| 5| 3| 3| 8| 3| 3| 0| 3| 3| 3| 3| 3| 3| 3| 3| 3| 0| 3| 1| 0| 3| | | 1| 1| 1| 1| 5| 0| 0| 8| 1| 0| 8| 1| 1| 0| 0| 0| 0| 1| 0| 0| 7| 0| 1| 8| 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 | B6C3F1 MICE 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| 1| A | 56 MG/KG | 7| 7| 7| 7| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 0| L | | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| | _____________________________________________________________________________________________________________________|____________| HEMATOPOIETIC SYSTEM - cont | | | |__________________________________________________________________________|____________| Lymph Node | + | 1 | |__________________________________________________________________________|____________| Lymph Node, Mandibular | + + M M + + + + M + + + + + + + + + + M M M M + M| 29 | |__________________________________________________________________________|____________| Lymph Node, Mesenteric | M + + + + + + + + + + + + + + + + + + + A + + + +| 46 | Infiltration Cellular, Histiocyte | 1 1 2 1 2 1 1 2 | 15 1.3| |__________________________________________________________________________|____________| Spleen | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Hematopoietic Cell Proliferation | 1 1 2 1 | 8 1.5| Infiltration Cellular, Histiocyte | 1 | 1 1.0| |__________________________________________________________________________|____________| Thymus | + + + + + + + M + M + + + + + + M + + + + I M + M| 39 | _____________________________________________________________________________________________________________________| | INTEGUMENTARY SYSTEM | | | |__________________________________________________________________________|____________| Mammary Gland | 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 | |__________________________________________________________________________|____________| Skin | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Subcutaneous Tissue, Edema | | 1 3.0| _____________________________________________________________________________________________________________________| | MUSCULOSKELETAL SYSTEM | | | |__________________________________________________________________________|____________| Bone | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Skeletal Muscle | + + | 2 | _____________________________________________________________________________________________________________________| | NERVOUS SYSTEM | | | |__________________________________________________________________________|____________| Brain | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | _____________________________________________________________________________________________________________________| | RESPIRATORY SYSTEM | | | |__________________________________________________________________________|____________| Lung | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | _____________________________________________________________________________________________________________________|____________| * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 61 NTP Experiment-Test: 88122-07 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC ELMIRON Date: 04/23/01 Route: GAVAGE Time: 15:23:02 __________________________________________________________________________________________________________________________________ | 7| 0| 7| 7| 4| 7| 7| 6| 7| 7| 5| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 3| 5| 7| | DAY ON TEST | 3| 1| 3| 3| 5| 3| 3| 8| 3| 3| 0| 3| 3| 3| 3| 3| 3| 3| 3| 3| 0| 3| 1| 0| 3| | | 1| 1| 1| 1| 5| 0| 0| 8| 1| 0| 8| 1| 1| 0| 0| 0| 0| 1| 0| 0| 7| 0| 1| 8| 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 | B6C3F1 MICE 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| 1| A | 56 MG/KG | 7| 7| 7| 7| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 0| L | | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| | _____________________________________________________________________________________________________________________|____________| RESPIRATORY SYSTEM - cont | | | Hemorrhage | 2 | 1 2.0| Alveolar Epithelium, Hyperplasia | 2 2 2 | 7 2.0| Mediastinum, Inflammation, Acute | 2 | 1 2.0| |__________________________________________________________________________|____________| Nose | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Olfactory Epithelium, Atrophy | 2 2 3 | 3 2.3| Olfactory Epithelium, Metaplasia | 2| 3 1.7| |__________________________________________________________________________|____________| Trachea | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | _____________________________________________________________________________________________________________________| | SPECIAL SENSES SYSTEM | | | |__________________________________________________________________________|____________| Eye | | 1 | Cornea, Inflammation, Chronic | | 1 3.0| |__________________________________________________________________________|____________| Harderian Gland | + + + + + + + + + M + + + + + + + + + + + + + +| 48 | Atrophy | | 1 2.0| Hyperplasia | | 1 3.0| Inflammation, Acute | 1 | 1 1.0| _____________________________________________________________________________________________________________________| | URINARY SYSTEM | | | |__________________________________________________________________________|____________| Kidney | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Infarct | | 3 2.3| Inflammation, Suppurative | 2 | 3 2.7| Metaplasia, Osseous | 1 | 1 1.0| Nephropathy | 2 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 2 2| 41 1.3| Papilla, Necrosis | 4 | 1 4.0| |__________________________________________________________________________|____________| Urinary Bladder | + + + + + + + + + + + + + + + + + + + + + + + + +| 49 | Transitional Epithelium, Hyperplasia | 3 | 1 3.0| __________________________________________________________________________________________________________________________________ * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 62 NTP Experiment-Test: 88122-07 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC ELMIRON Date: 04/23/01 Route: GAVAGE Time: 15:23:02 _____________________________________________________________________________________________________________________ | 7| 7| 7| 5| 7| 7| 7| 6| 7| 5| 7| 7| 7| 7| 7| 7| 7| 7| 5| 7| 7| 7| 6| 7| 7| DAY ON TEST | 3| 3| 3| 4| 3| 3| 3| 5| 3| 8| 3| 3| 3| 3| 3| 3| 3| 3| 9| 3| 3| 3| 1| 3| 3| | 1| 1| 1| 8| 1| 1| 1| 3| 0| 1| 1| 0| 0| 0| 0| 0| 1| 1| 2| 1| 1| 1| 1| 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| 0| B6C3F1 MICE 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| 168 | 0| 0| 0| 0| 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 2| MG/KG | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| __________________________________________|__________________________________________________________________________| ALIMENTARY SYSTEM | | |__________________________________________________________________________| Esophagus | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Gallbladder | + + + + + + + + + + + + + + + + + + A + M + + + M| Cyst | 1 | Epithelium, Hyperplasia | | |__________________________________________________________________________| Intestine Large, Colon | + + + + + + + + + + + + + + + + + + A + + + + + +| Necrosis | | |__________________________________________________________________________| Intestine Large, Rectum | + + + + + + + I + + + + + + + + + + A + + + + + +| Inflammation, Acute | | Inflammation, Chronic Active | | |__________________________________________________________________________| Intestine Large, Cecum | + + + + + + + A + + + + + + + + + + A + + + + + +| |__________________________________________________________________________| Intestine Small, Duodenum | + + + + + + + + + A + + + + + + + + A + + + + + +| |__________________________________________________________________________| Intestine Small, Jejunum | + + + + + + + A + A + + + + + + + + A + + + + + +| |__________________________________________________________________________| Intestine Small, Ileum | + + + + + + + A + A + + + + + + + + A + + + + + +| |__________________________________________________________________________| Liver | + + + + + + + + + + + + + + + + + + + + + + + + +| Basophilic Focus | X X X | Clear Cell Focus | X X X X X X X X X X | Eosinophilic Focus | X X X X | Fatty Change | 1 1 1 1 | Hematopoietic Cell Proliferation | 1 | Infarct | | Inflammation, Chronic | 1 1 1 1 1 1 1 1 1 1| Necrosis | 1 1 | Tension Lipidosis | X X | Centrilobular, Degeneration | | |__________________________________________________________________________| Mesentery | + + + + + + + + + + | Fat, Necrosis | 2 2 2 2 2 2 2 2 2 2 | |__________________________________________________________________________| Pancreas | + + + + + + + + + A + + + + + + + + + + + + + + +| __________________________________________|__________________________________________________________________________| Page 63 NTP Experiment-Test: 88122-07 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC ELMIRON Date: 04/23/01 Route: GAVAGE Time: 15:23:02 _____________________________________________________________________________________________________________________ | 7| 7| 7| 5| 7| 7| 7| 6| 7| 5| 7| 7| 7| 7| 7| 7| 7| 7| 5| 7| 7| 7| 6| 7| 7| DAY ON TEST | 3| 3| 3| 4| 3| 3| 3| 5| 3| 8| 3| 3| 3| 3| 3| 3| 3| 3| 9| 3| 3| 3| 1| 3| 3| | 1| 1| 1| 8| 1| 1| 1| 3| 0| 1| 1| 0| 0| 0| 0| 0| 1| 1| 2| 1| 1| 1| 1| 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| 0| B6C3F1 MICE 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| 168 | 0| 0| 0| 0| 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 2| MG/KG | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| __________________________________________|__________________________________________________________________________| ALIMENTARY SYSTEM - cont | | Atrophy | | Cyst | | |__________________________________________________________________________| Salivary Glands | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Stomach, Forestomach | + + + + + + + + + + + + + + + + + + + + + + + + +| Hyperplasia, Squamous | 1 | |__________________________________________________________________________| Stomach, Glandular | + + + + + + + + + + + + + + + + + + A + + + + + +| Necrosis | | |__________________________________________________________________________| Tooth | + + + + + + + + + + + + + + + | Inflammation, Chronic Active | 2 2 | Malformation | 1 2 1 1 2 1 2 1 1 1 1 2 3 3 | _____________________________________________________________________________________________________________________| CARDIOVASCULAR SYSTEM | | |__________________________________________________________________________| Heart | + + + + + + + + + + + + + + + + + + + + + + + + +| Cardiomyopathy | | Inflammation, Suppurative | | Mineralization | | Artery, Inflammation, Chronic Active | 2 | _____________________________________________________________________________________________________________________| ENDOCRINE SYSTEM | | |__________________________________________________________________________| Adrenal Cortex | + + + + + + + + + + + + + + + + + + + + + + + + +| Hyperplasia | 2 3 2 2 2 3 | Hypertrophy | 1 1 1 1 2 2 1 2 2 1 1 1 | |__________________________________________________________________________| Adrenal Medulla | + + + + + + + + + + + + + + + + + + + + + + + + +| Vacuolization Cytoplasmic | | |__________________________________________________________________________| Islets, Pancreatic | + + + + + + + + + A + + + + + + + + + + + + + + +| |__________________________________________________________________________| Parathyroid Gland | + + M + + + + M + + M + + + + + M M + + + M M + +| |__________________________________________________________________________| Pituitary Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| Pars Distalis, Hyperplasia | 1 1 | __________________________________________|__________________________________________________________________________| Page 64 NTP Experiment-Test: 88122-07 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC ELMIRON Date: 04/23/01 Route: GAVAGE Time: 15:23:02 _____________________________________________________________________________________________________________________ | 7| 7| 7| 5| 7| 7| 7| 6| 7| 5| 7| 7| 7| 7| 7| 7| 7| 7| 5| 7| 7| 7| 6| 7| 7| DAY ON TEST | 3| 3| 3| 4| 3| 3| 3| 5| 3| 8| 3| 3| 3| 3| 3| 3| 3| 3| 9| 3| 3| 3| 1| 3| 3| | 1| 1| 1| 8| 1| 1| 1| 3| 0| 1| 1| 0| 0| 0| 0| 0| 1| 1| 2| 1| 1| 1| 1| 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| 0| B6C3F1 MICE 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| 168 | 0| 0| 0| 0| 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 2| MG/KG | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| __________________________________________|__________________________________________________________________________| ENDOCRINE SYSTEM - cont | | |__________________________________________________________________________| Thyroid Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| GENERAL BODY SYSTEM | | None | | _____________________________________________________________________________________________________________________| GENITAL SYSTEM | | |__________________________________________________________________________| Epididymis | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Preputial Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| Ectasia | 2 2| Inflammation, Chronic Active | | |__________________________________________________________________________| Prostate | + + + + + + + + + + + + + + + + + + + + + + + + +| Inflammation, Chronic Active | | |__________________________________________________________________________| Seminal Vesicle | + + + + + + + + + + + + + + + + + + + + + + + + +| Dilatation | 3 3 | Inflammation, Chronic Active | 1 | |__________________________________________________________________________| Testes | + + + + + + + + + + + + + + + + + + + + + + + + +| Germinal Epithelium, Degeneration | | _____________________________________________________________________________________________________________________| HEMATOPOIETIC SYSTEM | | |__________________________________________________________________________| Bone Marrow | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Lymph Node | + | |__________________________________________________________________________| Lymph Node, Mandibular | M M + M + + + + + + + + + + + M M M M + + + + M +| |__________________________________________________________________________| Lymph Node, Mesenteric | + + + + + + + + + A M + + + + + + + A + + + + + +| Angiectasis | | Hematopoietic Cell Proliferation | | Hemorrhage | 2 | Infiltration Cellular, Histiocyte | 2 1 3 2 2 2 3 2 2 2 2 3 2 1 3 3 2 2| |__________________________________________________________________________| __________________________________________|__________________________________________________________________________| Page 65 NTP Experiment-Test: 88122-07 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC ELMIRON Date: 04/23/01 Route: GAVAGE Time: 15:23:02 _____________________________________________________________________________________________________________________ | 7| 7| 7| 5| 7| 7| 7| 6| 7| 5| 7| 7| 7| 7| 7| 7| 7| 7| 5| 7| 7| 7| 6| 7| 7| DAY ON TEST | 3| 3| 3| 4| 3| 3| 3| 5| 3| 8| 3| 3| 3| 3| 3| 3| 3| 3| 9| 3| 3| 3| 1| 3| 3| | 1| 1| 1| 8| 1| 1| 1| 3| 0| 1| 1| 0| 0| 0| 0| 0| 1| 1| 2| 1| 1| 1| 1| 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| 0| B6C3F1 MICE 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| 168 | 0| 0| 0| 0| 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 2| MG/KG | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| __________________________________________|__________________________________________________________________________| HEMATOPOIETIC SYSTEM - cont | | Spleen | + + + + + + + + + + + + + + + + + + + + + + + + +| Hematopoietic Cell Proliferation | 2 1 2 2 2 1 4 2 1| Infiltration Cellular, Histiocyte | 1 | |__________________________________________________________________________| Thymus | + + + + I + + + + M + + + + + + + M + M + M + + M| _____________________________________________________________________________________________________________________| INTEGUMENTARY SYSTEM | | |__________________________________________________________________________| Mammary Gland | 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| |__________________________________________________________________________| Skin | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| MUSCULOSKELETAL SYSTEM | | |__________________________________________________________________________| Bone | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| NERVOUS SYSTEM | | |__________________________________________________________________________| Brain | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| RESPIRATORY SYSTEM | | |__________________________________________________________________________| Lung | + + + + + + + + + + + + + + + + + + + + + + + + +| Hemorrhage | | Inflammation, Chronic Active | | Thrombosis | | Alveolar Epithelium, Hyperplasia | | Alveolus, Infiltration Cellular, | | Histiocyte | | |__________________________________________________________________________| Nose | + + + + + + + + + + + + + + + + + + + + + + + + +| Inflammation, Suppurative | 2 1 2 2 1 2| Glands, Degeneration, Hyaline | 4 | Olfactory Epithelium, Atrophy | | Olfactory Epithelium, Hyperplasia | 2 | Olfactory Epithelium, Metaplasia | 1 | Sinus, Inflammation, Chronic Active | 3 | |__________________________________________________________________________| __________________________________________|__________________________________________________________________________| Page 66 NTP Experiment-Test: 88122-07 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC ELMIRON Date: 04/23/01 Route: GAVAGE Time: 15:23:02 _____________________________________________________________________________________________________________________ | 7| 7| 7| 5| 7| 7| 7| 6| 7| 5| 7| 7| 7| 7| 7| 7| 7| 7| 5| 7| 7| 7| 6| 7| 7| DAY ON TEST | 3| 3| 3| 4| 3| 3| 3| 5| 3| 8| 3| 3| 3| 3| 3| 3| 3| 3| 9| 3| 3| 3| 1| 3| 3| | 1| 1| 1| 8| 1| 1| 1| 3| 0| 1| 1| 0| 0| 0| 0| 0| 1| 1| 2| 1| 1| 1| 1| 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| 0| B6C3F1 MICE 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| 168 | 0| 0| 0| 0| 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 2| MG/KG | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| __________________________________________|__________________________________________________________________________| RESPIRATORY SYSTEM - cont | | Trachea | + + + + + + + + + + + + + + + + + + A + + + + + +| _____________________________________________________________________________________________________________________| SPECIAL SENSES SYSTEM | | |__________________________________________________________________________| Eye | + | Cornea, Inflammation, Chronic | 2 | |__________________________________________________________________________| Harderian Gland | + + + + + + + + + M + + + + + + + + + + + + + + +| Atrophy | 2| Hyperplasia | 2 | Inflammation, Acute | | _____________________________________________________________________________________________________________________| URINARY SYSTEM | | |__________________________________________________________________________| Kidney | + + + + + + + + + + + + + + + + + + + + + + + + +| Cyst | 2 3 2 | Hydronephrosis | | Infarct | 2 | Inflammation, Suppurative | | Nephropathy | 2 1 1 2 2 1 1 2 1 3 1 1 1 2 2 1 1 1 1 3 2 2 1 2| Renal Tubule, Hyperplasia | 1 | |__________________________________________________________________________| Urinary Bladder | + + + + + + + + + + + + + + + + + + A + + + + + +| Artery, Inflammation, Chronic Active | 2 | __________________________________________|__________________________________________________________________________ Page 67 NTP Experiment-Test: 88122-07 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC ELMIRON Date: 04/23/01 Route: GAVAGE Time: 15:23:02 __________________________________________________________________________________________________________________________________ | 4| 7| 7| 7| 7| 7| 7| 6| 7| 7| 7| 6| 7| 5| 7| 6| 7| 7| 7| 7| 7| 7| 7| 6| 7| | DAY ON TEST | 6| 3| 3| 3| 3| 3| 3| 4| 3| 3| 3| 8| 3| 9| 3| 5| 3| 3| 3| 3| 3| 3| 3| 2| 2| | | 5| 1| 0| 1| 0| 0| 0| 1| 0| 0| 1| 0| 0| 7| 0| 3| 1| 1| 0| 1| 0| 0| 1| 0| 5| | __________________________________________|__________________________________________________________________________| 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 | B6C3F1 MICE 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 | 168 | 2| 2| 2| 2| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 5| L | MG/KG | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| | _____________________________________________________________________________________________________________________|____________| ALIMENTARY SYSTEM | | | |__________________________________________________________________________|____________| Esophagus | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Gallbladder | A + + + + M + M + + M A + A + + + + + + + + I A +| 39 | Cyst | | 1 1.0| Epithelium, Hyperplasia | 1 | 1 1.0| |__________________________________________________________________________|____________| Intestine Large, Colon | + + + + + + + + + + + A + A + + + + + + + + + + +| 47 | Necrosis | 1 | 1 1.0| |__________________________________________________________________________|____________| Intestine Large, Rectum | A + + + + + + + + + + + + A + + + + + + + + + + +| 46 | Inflammation, Acute | 4 | 1 4.0| Inflammation, Chronic Active | 1 | 1 1.0| |__________________________________________________________________________|____________| Intestine Large, Cecum | A + + + + + + + + + + + + A + + + + + + + + + + +| 46 | |__________________________________________________________________________|____________| Intestine Small, Duodenum | A + + + + + + + + + + A + A + + + + + + + + + A +| 44 | |__________________________________________________________________________|____________| Intestine Small, Jejunum | A + + + + + + + + + + A + A + + + + + + + + + + +| 44 | |__________________________________________________________________________|____________| Intestine Small, Ileum | A + + + + + + + + + + A + A + + + + + M + + + + +| 43 | |__________________________________________________________________________|____________| Liver | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Basophilic Focus | X X | 5 | Clear Cell Focus | X X X X X X X X X | 19 | Eosinophilic Focus | X X X X X | 9 | Fatty Change | 1 1 1 1 | 8 1.0| Hematopoietic Cell Proliferation | | 1 1.0| Infarct | 2| 1 2.0| Inflammation, Chronic | 1 2 1 1 1 1 1 1 1 1 1 1 1| 23 1.0| Necrosis | | 2 1.0| Tension Lipidosis | | 2 | Centrilobular, Degeneration | 2 1 3 | 3 2.0| |__________________________________________________________________________|____________| _____________________________________________________________________________________________________________________|____________| * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 68 NTP Experiment-Test: 88122-07 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC ELMIRON Date: 04/23/01 Route: GAVAGE Time: 15:23:02 __________________________________________________________________________________________________________________________________ | 4| 7| 7| 7| 7| 7| 7| 6| 7| 7| 7| 6| 7| 5| 7| 6| 7| 7| 7| 7| 7| 7| 7| 6| 7| | DAY ON TEST | 6| 3| 3| 3| 3| 3| 3| 4| 3| 3| 3| 8| 3| 9| 3| 5| 3| 3| 3| 3| 3| 3| 3| 2| 2| | | 5| 1| 0| 1| 0| 0| 0| 1| 0| 0| 1| 0| 0| 7| 0| 3| 1| 1| 0| 1| 0| 0| 1| 0| 5| | __________________________________________|__________________________________________________________________________| 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 | B6C3F1 MICE 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 | 168 | 2| 2| 2| 2| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 5| L | MG/KG | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| | _____________________________________________________________________________________________________________________|____________| ALIMENTARY SYSTEM - cont | | | Mesentery | + + + + + + + + + + | 20 | Fat, Necrosis | 2 2 2 3 2 2 2 2 2 | 19 2.1| |__________________________________________________________________________|____________| Pancreas | + + + + + + + + + + + + + + + + + + + + + + + + +| 49 | Atrophy | 4 | 1 4.0| Cyst | 4 | 1 4.0| |__________________________________________________________________________|____________| Salivary Glands | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Stomach, Forestomach | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Hyperplasia, Squamous | 1 | 2 1.0| |__________________________________________________________________________|____________| Stomach, Glandular | + + + + + + + + + + + + + A + + + + + + + + + + +| 48 | Necrosis | 2 | 1 2.0| |__________________________________________________________________________|____________| Tooth | + + + + + + + + + + + + + + + | 30 | Inflammation, Chronic Active | 2 3 3 | 5 2.4| Malformation | 2 1 1 1 2 1 1 1 2 1 3 1 1 | 27 1.5| _____________________________________________________________________________________________________________________| | CARDIOVASCULAR SYSTEM | | | |__________________________________________________________________________|____________| Heart | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Cardiomyopathy | 1 | 1 1.0| Inflammation, Suppurative | 3 | 1 3.0| Mineralization | 1 | 1 1.0| Artery, Inflammation, Chronic Active | 3 2 | 3 2.3| _____________________________________________________________________________________________________________________| | ENDOCRINE SYSTEM | | | |__________________________________________________________________________|____________| Adrenal Cortex | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Hyperplasia | 2 2 | 8 2.3| Hypertrophy | 2 1 1 3 2 1 1 2 2 1 1 | 23 1.4| |__________________________________________________________________________|____________| Adrenal Medulla | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | _____________________________________________________________________________________________________________________|____________| * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 69 NTP Experiment-Test: 88122-07 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC ELMIRON Date: 04/23/01 Route: GAVAGE Time: 15:23:02 __________________________________________________________________________________________________________________________________ | 4| 7| 7| 7| 7| 7| 7| 6| 7| 7| 7| 6| 7| 5| 7| 6| 7| 7| 7| 7| 7| 7| 7| 6| 7| | DAY ON TEST | 6| 3| 3| 3| 3| 3| 3| 4| 3| 3| 3| 8| 3| 9| 3| 5| 3| 3| 3| 3| 3| 3| 3| 2| 2| | | 5| 1| 0| 1| 0| 0| 0| 1| 0| 0| 1| 0| 0| 7| 0| 3| 1| 1| 0| 1| 0| 0| 1| 0| 5| | __________________________________________|__________________________________________________________________________| 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 | B6C3F1 MICE 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 | 168 | 2| 2| 2| 2| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 5| L | MG/KG | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| | _____________________________________________________________________________________________________________________|____________| ENDOCRINE SYSTEM - cont | | | Vacuolization Cytoplasmic | 2 | 1 2.0| |__________________________________________________________________________|____________| Islets, Pancreatic | + + + + + + + + + + + + + + + + + + + + + + + + +| 49 | |__________________________________________________________________________|____________| Parathyroid Gland | + M M + + M + + M + I + + + + + + + + M + + + + +| 37 | |__________________________________________________________________________|____________| Pituitary Gland | + + + + M + + + + + + + + + + + + + + + + + + + +| 49 | Pars Distalis, Hyperplasia | 2 | 3 1.3| |__________________________________________________________________________|____________| Thyroid Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | _____________________________________________________________________________________________________________________| | GENERAL BODY SYSTEM | | | None | | | _____________________________________________________________________________________________________________________| | GENITAL SYSTEM | | | |__________________________________________________________________________|____________| Epididymis | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Preputial Gland | + + + + + + + + + + + M + + + + + + + + + + + + +| 49 | Ectasia | 2 3 3 | 5 2.4| Inflammation, Chronic Active | 2 3 | 2 2.5| |__________________________________________________________________________|____________| Prostate | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Inflammation, Chronic Active | 3 | 1 3.0| |__________________________________________________________________________|____________| Seminal Vesicle | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Dilatation | 2 3 3 | 5 2.8| Inflammation, Chronic Active | | 1 1.0| |__________________________________________________________________________|____________| Testes | + + + + + + + + + + + A + + + + + + + + + + + + +| 49 | Germinal Epithelium, Degeneration | 2| 1 2.0| _____________________________________________________________________________________________________________________| | HEMATOPOIETIC SYSTEM | | | |__________________________________________________________________________|____________| _____________________________________________________________________________________________________________________|____________| * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 70 NTP Experiment-Test: 88122-07 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC ELMIRON Date: 04/23/01 Route: GAVAGE Time: 15:23:02 __________________________________________________________________________________________________________________________________ | 4| 7| 7| 7| 7| 7| 7| 6| 7| 7| 7| 6| 7| 5| 7| 6| 7| 7| 7| 7| 7| 7| 7| 6| 7| | DAY ON TEST | 6| 3| 3| 3| 3| 3| 3| 4| 3| 3| 3| 8| 3| 9| 3| 5| 3| 3| 3| 3| 3| 3| 3| 2| 2| | | 5| 1| 0| 1| 0| 0| 0| 1| 0| 0| 1| 0| 0| 7| 0| 3| 1| 1| 0| 1| 0| 0| 1| 0| 5| | __________________________________________|__________________________________________________________________________| 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 | B6C3F1 MICE 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 | 168 | 2| 2| 2| 2| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 5| L | MG/KG | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| | _____________________________________________________________________________________________________________________|____________| HEMATOPOIETIC SYSTEM - cont | | | Bone Marrow | + + + + + + + + + + + + + A + + + + + + + + + + +| 49 | |__________________________________________________________________________|____________| Lymph Node | | 1 | |__________________________________________________________________________|____________| Lymph Node, Mandibular | M M M M M + + M + + M M M + + M + + + + + + + M M| 30 | |__________________________________________________________________________|____________| Lymph Node, Mesenteric | + + + + + + + + + + + A + A + + + + + + + + + + +| 45 | Angiectasis | 2 2 3| 3 2.3| Hematopoietic Cell Proliferation | 3 | 1 3.0| Hemorrhage | | 1 2.0| Infiltration Cellular, Histiocyte | 2 1 2 2 2 2 2 2 2 2 3 2 3 2 2 2 | 34 2.1| |__________________________________________________________________________|____________| Spleen | + + + + + + + + + + + + + A + + + + + + + + + + +| 49 | Hematopoietic Cell Proliferation | 2 2 2 2 2 2| 15 1.9| Infiltration Cellular, Histiocyte | | 1 1.0| |__________________________________________________________________________|____________| Thymus | + + + + + + + + M + + M + + + + + + + M + + M + M| 39 | _____________________________________________________________________________________________________________________| | INTEGUMENTARY SYSTEM | | | |__________________________________________________________________________|____________| Mammary Gland | 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| | |__________________________________________________________________________|____________| Skin | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | _____________________________________________________________________________________________________________________| | MUSCULOSKELETAL SYSTEM | | | |__________________________________________________________________________|____________| Bone | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | _____________________________________________________________________________________________________________________| | NERVOUS SYSTEM | | | |__________________________________________________________________________|____________| Brain | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | _____________________________________________________________________________________________________________________| | RESPIRATORY SYSTEM | | | |__________________________________________________________________________|____________| _____________________________________________________________________________________________________________________|____________| * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 71 NTP Experiment-Test: 88122-07 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC ELMIRON Date: 04/23/01 Route: GAVAGE Time: 15:23:02 __________________________________________________________________________________________________________________________________ | 4| 7| 7| 7| 7| 7| 7| 6| 7| 7| 7| 6| 7| 5| 7| 6| 7| 7| 7| 7| 7| 7| 7| 6| 7| | DAY ON TEST | 6| 3| 3| 3| 3| 3| 3| 4| 3| 3| 3| 8| 3| 9| 3| 5| 3| 3| 3| 3| 3| 3| 3| 2| 2| | | 5| 1| 0| 1| 0| 0| 0| 1| 0| 0| 1| 0| 0| 7| 0| 3| 1| 1| 0| 1| 0| 0| 1| 0| 5| | __________________________________________|__________________________________________________________________________| 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 | B6C3F1 MICE 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 | 168 | 2| 2| 2| 2| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 5| L | MG/KG | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| | _____________________________________________________________________________________________________________________|____________| RESPIRATORY SYSTEM - cont | | | Lung | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Hemorrhage | 1 | 1 1.0| Inflammation, Chronic Active | 1 | 1 1.0| Thrombosis | 2 | 1 2.0| Alveolar Epithelium, Hyperplasia | 2 2 3 2 | 4 2.3| Alveolus, Infiltration Cellular, | | | Histiocyte | 1 | 1 1.0| |__________________________________________________________________________|____________| Nose | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Inflammation, Suppurative | 1 1 1 1 1 | 11 1.4| Glands, Degeneration, Hyaline | | 1 4.0| Olfactory Epithelium, Atrophy | 2 | 1 2.0| Olfactory Epithelium, Hyperplasia | | 1 2.0| Olfactory Epithelium, Metaplasia | | 1 1.0| Sinus, Inflammation, Chronic Active | | 1 3.0| |__________________________________________________________________________|____________| Trachea | + + + + + + + + + + + + + + + + + + + + + + + + +| 49 | _____________________________________________________________________________________________________________________| | SPECIAL SENSES SYSTEM | | | |__________________________________________________________________________|____________| Eye | + | 2 | Cornea, Inflammation, Chronic | 1 | 2 1.5| |__________________________________________________________________________|____________| Harderian Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| 49 | Atrophy | | 1 2.0| Hyperplasia | | 1 2.0| Inflammation, Acute | 1 3| 2 2.0| _____________________________________________________________________________________________________________________| | URINARY SYSTEM | | | |__________________________________________________________________________|____________| Kidney | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Cyst | | 3 2.3| Hydronephrosis | 3 | 1 3.0| Infarct | 2 2 2 | 4 2.0| _____________________________________________________________________________________________________________________|____________| * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 72 NTP Experiment-Test: 88122-07 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC ELMIRON Date: 04/23/01 Route: GAVAGE Time: 15:23:02 __________________________________________________________________________________________________________________________________ | 4| 7| 7| 7| 7| 7| 7| 6| 7| 7| 7| 6| 7| 5| 7| 6| 7| 7| 7| 7| 7| 7| 7| 6| 7| | DAY ON TEST | 6| 3| 3| 3| 3| 3| 3| 4| 3| 3| 3| 8| 3| 9| 3| 5| 3| 3| 3| 3| 3| 3| 3| 2| 2| | | 5| 1| 0| 1| 0| 0| 0| 1| 0| 0| 1| 0| 0| 7| 0| 3| 1| 1| 0| 1| 0| 0| 1| 0| 5| | __________________________________________|__________________________________________________________________________| 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 | B6C3F1 MICE 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 | 168 | 2| 2| 2| 2| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 5| L | MG/KG | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| | _____________________________________________________________________________________________________________________|____________| URINARY SYSTEM - cont | | | Inflammation, Suppurative | 3 2 2 | 3 2.3| Nephropathy | 2 1 3 1 1 2 2 1 2 2 1 2 1 1 1 2 2 1 4 1 1 2 2| 47 1.6| Renal Tubule, Hyperplasia | 2 | 2 1.5| |__________________________________________________________________________|____________| Urinary Bladder | + + + + + + + + + + + + + + + + + + + + + + + + +| 49 | Artery, Inflammation, Chronic Active | | 1 2.0| __________________________________________________________________________________________________________________________________ * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 73 NTP Experiment-Test: 88122-07 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC ELMIRON Date: 04/23/01 Route: GAVAGE Time: 15:23:02 _____________________________________________________________________________________________________________________ | 6| 7| 7| 6| 6| 7| 0| 6| 6| 6| 7| 4| 6| 7| 5| 7| 5| 7| 7| 7| 5| 7| 7| 7| 7| DAY ON TEST | 7| 3| 3| 2| 5| 3| 1| 4| 5| 1| 3| 8| 2| 3| 7| 3| 9| 3| 3| 3| 3| 3| 3| 3| 3| | 6| 1| 0| 1| 7| 1| 7| 6| 8| 7| 0| 3| 6| 0| 6| 1| 0| 1| 1| 0| 9| 0| 0| 1| 1| __________________________________________|__________________________________________________________________________| | 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| B6C3F1 MICE 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| 504 | 5| 5| 5| 5| 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 7| MG/KG | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| __________________________________________|__________________________________________________________________________| ALIMENTARY SYSTEM | | |__________________________________________________________________________| Esophagus | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Gallbladder | A + M A A + A A A A + + M + + + + + + + A + I + +| Degeneration, Hyaline | 3 | |__________________________________________________________________________| Intestine Large, Colon | A + + + A + A + A A + + + + + + + + + + A + + + +| |__________________________________________________________________________| Intestine Large, Rectum | A + + + + + + + A + + + A + + + + + + + A + + + +| Infiltration Cellular, Histiocyte | 1 1 1 | Inflammation, Chronic Active | 1 2 3 1| Metaplasia, Squamous | 3 1 1 | Myxomatous Change | 1 1 1 1 1 2 | Necrosis | 1 2 | |__________________________________________________________________________| Intestine Large, Cecum | A + + A A + A + A A + A + + + + + + + + A + + + +| Inflammation, Chronic Active | | Necrosis | | |__________________________________________________________________________| Intestine Small, Duodenum | A + + A A + A + A A + A + + + + + + + + A + + + +| |__________________________________________________________________________| Intestine Small, Jejunum | A + + A A + + + A A + A A + + + + + + + A + + + +| Hyperplasia, Lymphoid | | |__________________________________________________________________________| Intestine Small, Ileum | A + + A A + A + A A + A A + + + + + + + A + + + +| Inflammation, Acute | | |__________________________________________________________________________| Liver | + + + + + + + + + + + + + + + + + + + + + + + + +| Basophilic Focus | X X X X | Clear Cell Focus | X X X X X X X | Eosinophilic Focus | X X X X X | Fatty Change | 1 1 1 1 1 1 1 1 1| Inflammation, Chronic | 1 1 1 2 1 1 1 1 1 1 1 1 2 1 1| Necrosis | 2 2 2 3 | Centrilobular, Degeneration | 2 2 2 2 | |__________________________________________________________________________| Mesentery | + + + + + | Fat, Necrosis | 2 2 2 2 2 | __________________________________________|__________________________________________________________________________| Page 74 NTP Experiment-Test: 88122-07 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC ELMIRON Date: 04/23/01 Route: GAVAGE Time: 15:23:02 _____________________________________________________________________________________________________________________ | 6| 7| 7| 6| 6| 7| 0| 6| 6| 6| 7| 4| 6| 7| 5| 7| 5| 7| 7| 7| 5| 7| 7| 7| 7| DAY ON TEST | 7| 3| 3| 2| 5| 3| 1| 4| 5| 1| 3| 8| 2| 3| 7| 3| 9| 3| 3| 3| 3| 3| 3| 3| 3| | 6| 1| 0| 1| 7| 1| 7| 6| 8| 7| 0| 3| 6| 0| 6| 1| 0| 1| 1| 0| 9| 0| 0| 1| 1| __________________________________________|__________________________________________________________________________| | 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| B6C3F1 MICE 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| 504 | 5| 5| 5| 5| 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 7| MG/KG | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| __________________________________________|__________________________________________________________________________| ALIMENTARY SYSTEM - cont | | |__________________________________________________________________________| Pancreas | + + + + + + + + + + + + + + + + + + + + + + + + +| Atrophy | | |__________________________________________________________________________| Salivary Glands | I + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Stomach, Forestomach | + + + + + + + + + + + + + + + + + + + + + + + + +| Hyperplasia, Squamous | 2 1 | Inflammation, Acute | 2 | Ulcer | 3 | |__________________________________________________________________________| Stomach, Glandular | + + + A A + + + + + + A + + + + + + + + + + + + +| Inflammation, Chronic Active | | Mineralization | 2 | Necrosis | | |__________________________________________________________________________| Tooth | + + + + + + + +| Inflammation, Chronic Active | 2 | Malformation | 2 1 1 1 1 1 1 2| _____________________________________________________________________________________________________________________| CARDIOVASCULAR SYSTEM | | |__________________________________________________________________________| Blood Vessel | + | |__________________________________________________________________________| Heart | + + + + + + + + + + + + + + + + + + + + + + + + +| Cardiomyopathy | 1 1 | Mineralization | 2 1 | _____________________________________________________________________________________________________________________| ENDOCRINE SYSTEM | | |__________________________________________________________________________| Adrenal Cortex | + + + + + + + + + M + + + + + + + + + + + + + + +| Hyperplasia | 3 2 2 3 2 2 2 | Hypertrophy | 2 2 1 1 2 2 3 2 | |__________________________________________________________________________| Adrenal Medulla | + + + + + + + + + M + + + + + + + + + + + + + + +| Hyperplasia | | |__________________________________________________________________________| Islets, Pancreatic | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________|__________________________________________________________________________| Page 75 NTP Experiment-Test: 88122-07 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC ELMIRON Date: 04/23/01 Route: GAVAGE Time: 15:23:02 _____________________________________________________________________________________________________________________ | 6| 7| 7| 6| 6| 7| 0| 6| 6| 6| 7| 4| 6| 7| 5| 7| 5| 7| 7| 7| 5| 7| 7| 7| 7| DAY ON TEST | 7| 3| 3| 2| 5| 3| 1| 4| 5| 1| 3| 8| 2| 3| 7| 3| 9| 3| 3| 3| 3| 3| 3| 3| 3| | 6| 1| 0| 1| 7| 1| 7| 6| 8| 7| 0| 3| 6| 0| 6| 1| 0| 1| 1| 0| 9| 0| 0| 1| 1| __________________________________________|__________________________________________________________________________| | 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| B6C3F1 MICE 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| 504 | 5| 5| 5| 5| 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 7| MG/KG | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| __________________________________________|__________________________________________________________________________| ENDOCRINE SYSTEM - cont | | |__________________________________________________________________________| Parathyroid Gland | + + + + + M M M + + M + + + + I + + + + + + I + +| |__________________________________________________________________________| Pituitary Gland | M + + + + + + + + + + + + + + + + + + + + + + + +| Pars Distalis, Hyperplasia | | |__________________________________________________________________________| Thyroid Gland | + + + + + + M + + + + + + + + + + + + + + + + + +| Follicular Cell, Hyperplasia | 1 | _____________________________________________________________________________________________________________________| GENERAL BODY SYSTEM | | None | | _____________________________________________________________________________________________________________________| GENITAL SYSTEM | | |__________________________________________________________________________| Epididymis | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Preputial Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| Ectasia | 2 | Infiltration Cellular, Histiocyte | 3 | Inflammation, Chronic Active | 2 | |__________________________________________________________________________| Prostate | + + + + + + + + + + + + + + + + + + + + + + + + +| Inflammation, Chronic Active | 4 | |__________________________________________________________________________| Seminal Vesicle | + + + + + + + + + M + + + + + + + + + + + + + + +| Inflammation, Chronic Active | | |__________________________________________________________________________| Testes | + + + + + + + + + + + + + + + + + + + + + + + + +| Germinal Epithelium, Degeneration | 2 | _____________________________________________________________________________________________________________________| HEMATOPOIETIC SYSTEM | | |__________________________________________________________________________| Bone Marrow | + + + + + + + + + + + + + + + + + + + + + + + + +| Angiectasis | | |__________________________________________________________________________| Lymph Node | | Mediastinal, Infiltration Cellular, | | Histiocyte | | __________________________________________|__________________________________________________________________________| Page 76 NTP Experiment-Test: 88122-07 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC ELMIRON Date: 04/23/01 Route: GAVAGE Time: 15:23:02 _____________________________________________________________________________________________________________________ | 6| 7| 7| 6| 6| 7| 0| 6| 6| 6| 7| 4| 6| 7| 5| 7| 5| 7| 7| 7| 5| 7| 7| 7| 7| DAY ON TEST | 7| 3| 3| 2| 5| 3| 1| 4| 5| 1| 3| 8| 2| 3| 7| 3| 9| 3| 3| 3| 3| 3| 3| 3| 3| | 6| 1| 0| 1| 7| 1| 7| 6| 8| 7| 0| 3| 6| 0| 6| 1| 0| 1| 1| 0| 9| 0| 0| 1| 1| __________________________________________|__________________________________________________________________________| | 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| B6C3F1 MICE 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| 504 | 5| 5| 5| 5| 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 7| MG/KG | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| __________________________________________|__________________________________________________________________________| HEMATOPOIETIC SYSTEM - cont | | |__________________________________________________________________________| Lymph Node, Mandibular | + M + + M + + M M + + + + + M + M + M M M M + + +| |__________________________________________________________________________| Lymph Node, Mesenteric | A + + A A + A + A + + + + + + + + + + + + + + + +| Infiltration Cellular, Histiocyte | 1 3 2 1 2 3 3 2 2 1 1 2 3 1 2 2 1 2 3| |__________________________________________________________________________| Spleen | + + + + A + + + + + + + + + + + + + + + + + + + +| Amyloid Deposition | | Hematopoietic Cell Proliferation | 2 1 2 2 3 2 3 1 | Infiltration Cellular, Mast Cell | 3 | Infiltration Cellular, Histiocyte | 1 1 1 1 1 1 1 1 1 1 1 1| |__________________________________________________________________________| Thymus | M + + + + + + M M M + + + + + + M + + + M + M M +| _____________________________________________________________________________________________________________________| INTEGUMENTARY SYSTEM | | |__________________________________________________________________________| Mammary Gland | 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| |__________________________________________________________________________| Skin | + + + + + + + + + + + + + + + + + + + + + + + + +| Inflammation, Chronic Active | 3 | _____________________________________________________________________________________________________________________| MUSCULOSKELETAL SYSTEM | | |__________________________________________________________________________| Bone | + + + + + + + + + + + + + + + + + + + + + + + + +| |__________________________________________________________________________| Skeletal Muscle | | _____________________________________________________________________________________________________________________| NERVOUS SYSTEM | | |__________________________________________________________________________| Brain | + + + + + + + + + + + + + + + + + + + + + + + + +| Hemorrhage | | |__________________________________________________________________________| Spinal Cord | + | _____________________________________________________________________________________________________________________| RESPIRATORY SYSTEM | | |__________________________________________________________________________| Lung | + + + + + + + + + + + + + + + + + + + + + + + + +| Hemorrhage | 2 | __________________________________________|__________________________________________________________________________| Page 77 NTP Experiment-Test: 88122-07 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC ELMIRON Date: 04/23/01 Route: GAVAGE Time: 15:23:02 _____________________________________________________________________________________________________________________ | 6| 7| 7| 6| 6| 7| 0| 6| 6| 6| 7| 4| 6| 7| 5| 7| 5| 7| 7| 7| 5| 7| 7| 7| 7| DAY ON TEST | 7| 3| 3| 2| 5| 3| 1| 4| 5| 1| 3| 8| 2| 3| 7| 3| 9| 3| 3| 3| 3| 3| 3| 3| 3| | 6| 1| 0| 1| 7| 1| 7| 6| 8| 7| 0| 3| 6| 0| 6| 1| 0| 1| 1| 0| 9| 0| 0| 1| 1| __________________________________________|__________________________________________________________________________| | 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| B6C3F1 MICE 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| 504 | 5| 5| 5| 5| 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 7| MG/KG | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| __________________________________________|__________________________________________________________________________| RESPIRATORY SYSTEM - cont | | Mineralization | 1 | Alveolar Epithelium, Hyperplasia | 2 | Alveolus, Infiltration Cellular, | | Histiocyte | 3 | Mediastinum, Hemorrhage | | Mediastinum, Inflammation, Acute | | |__________________________________________________________________________| Nose | + + + + + + A + + + + + + + + + + + + + + + + +| Inflammation, Suppurative | 1 | Olfactory Epithelium, Metaplasia | 1 | |__________________________________________________________________________| Pleura | | |__________________________________________________________________________| Trachea | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| SPECIAL SENSES SYSTEM | | |__________________________________________________________________________| Eye | | |__________________________________________________________________________| Harderian Gland | + + + + + + + + + + + + + + + M + + + + + + + +| Hyperplasia | | |__________________________________________________________________________| Zymbal's Gland | | _____________________________________________________________________________________________________________________| URINARY SYSTEM | | |__________________________________________________________________________| Kidney | + + + + A + + + + + + + + + + + + + + + + + + + +| Cyst | 2 | Hydronephrosis | 2 | Infiltration Cellular, Mast Cell | 1| Inflammation, Suppurative | 2 | Nephropathy | 1 1 2 1 1 2 2 2 2 1 1 1 2 2 2 1 1 3 2 2| |__________________________________________________________________________| Urinary Bladder | + + + + A + + + + + + + + + + + + + + + + + + + +| __________________________________________|__________________________________________________________________________ Page 78 NTP Experiment-Test: 88122-07 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC ELMIRON Date: 04/23/01 Route: GAVAGE Time: 15:23:02 __________________________________________________________________________________________________________________________________ | 4| 7| 6| 7| 7| 7| 4| 7| 7| 7| 7| 7| 6| 7| 0| 6| 7| 7| 7| 7| 7| 7| 7| 7| 5| | DAY ON TEST | 9| 3| 6| 2| 3| 3| 9| 3| 3| 3| 3| 3| 3| 3| 1| 9| 3| 3| 3| 3| 3| 3| 3| 3| 8| | | 2| 0| 8| 1| 0| 1| 8| 1| 0| 0| 1| 1| 1| 1| 1| 5| 0| 1| 0| 0| 1| 0| 0| 0| 4| | __________________________________________|__________________________________________________________________________| 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 | B6C3F1 MICE 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| 2| A | 504 | 7| 7| 7| 7| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 0| L | MG/KG | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| | _____________________________________________________________________________________________________________________|____________| ALIMENTARY SYSTEM | | | |__________________________________________________________________________|____________| Esophagus | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Gallbladder | A M M + + M + + + + + + + + + A + + + + + + + + +| 34 | Degeneration, Hyaline | | 1 3.0| |__________________________________________________________________________|____________| Intestine Large, Colon | + + + + + + + + + + + + A + + A + + + + + + + + +| 42 | |__________________________________________________________________________|____________| Intestine Large, Rectum | + + + + + + + + + + + + A + + A + + + + + + + + +| 44 | Infiltration Cellular, Histiocyte | 1 1 1| 6 1.0| Inflammation, Chronic Active | 3 2 2 2| 8 2.0| Metaplasia, Squamous | 2 1 | 5 1.6| Myxomatous Change | 1 2 2 1 1 2 2| 13 1.4| Necrosis | 2 2 3| 5 2.0| |__________________________________________________________________________|____________| Intestine Large, Cecum | A + + + + + + + + + + + A + + A + + + + + + + + +| 39 | Inflammation, Chronic Active | 2 2| 2 2.0| Necrosis | 2| 1 2.0| |__________________________________________________________________________|____________| Intestine Small, Duodenum | + + + + + + + + + + + + A + + A + + + + + + + + +| 40 | |__________________________________________________________________________|____________| Intestine Small, Jejunum | A + A + + + + + + + + + A + + A + + + + + + + + +| 38 | Hyperplasia, Lymphoid | 4 | 1 4.0| |__________________________________________________________________________|____________| Intestine Small, Ileum | A + + + + + + + + + + + A + + A + + + + + + + + +| 38 | Inflammation, Acute | 2 | 1 2.0| |__________________________________________________________________________|____________| Liver | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Basophilic Focus | X X X X X X | 10 | Clear Cell Focus | X X X X X X X X | 15 | Eosinophilic Focus | X X X X X X X | 12 | Fatty Change | 2 1 1 1 | 13 1.1| Inflammation, Chronic | 2 1 3 1 1 1 1 1 1 1 2 1 1 1 3 3 1 1 | 33 1.3| Necrosis | 1 | 5 2.0| _____________________________________________________________________________________________________________________|____________| * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 79 NTP Experiment-Test: 88122-07 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC ELMIRON Date: 04/23/01 Route: GAVAGE Time: 15:23:02 __________________________________________________________________________________________________________________________________ | 4| 7| 6| 7| 7| 7| 4| 7| 7| 7| 7| 7| 6| 7| 0| 6| 7| 7| 7| 7| 7| 7| 7| 7| 5| | DAY ON TEST | 9| 3| 6| 2| 3| 3| 9| 3| 3| 3| 3| 3| 3| 3| 1| 9| 3| 3| 3| 3| 3| 3| 3| 3| 8| | | 2| 0| 8| 1| 0| 1| 8| 1| 0| 0| 1| 1| 1| 1| 1| 5| 0| 1| 0| 0| 1| 0| 0| 0| 4| | __________________________________________|__________________________________________________________________________| 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 | B6C3F1 MICE 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| 2| A | 504 | 7| 7| 7| 7| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 0| L | MG/KG | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| | _____________________________________________________________________________________________________________________|____________| ALIMENTARY SYSTEM - cont | | | Centrilobular, Degeneration | | 4 2.0| |__________________________________________________________________________|____________| Mesentery | + + + + + | 10 | Fat, Necrosis | 2 2 2 2 2 | 10 2.0| |__________________________________________________________________________|____________| Pancreas | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Atrophy | 2 | 1 2.0| |__________________________________________________________________________|____________| Salivary Glands | + + + + + + + + + + + + + + + + + + + + + + + + +| 49 | |__________________________________________________________________________|____________| Stomach, Forestomach | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Hyperplasia, Squamous | 2 | 3 1.7| Inflammation, Acute | | 1 2.0| Ulcer | | 1 3.0| |__________________________________________________________________________|____________| Stomach, Glandular | + + + + + + + + + + + + + + + A + + + + + + + + +| 46 | Inflammation, Chronic Active | 2 | 1 2.0| Mineralization | | 1 2.0| Necrosis | 2 | 1 2.0| |__________________________________________________________________________|____________| Tooth | + + + + + + + + + + + + + + + | 23 | Inflammation, Chronic Active | 1 2 2 3 2 | 6 2.0| Malformation | 1 1 1 1 1 1 1 1 1 1 1 1 | 20 1.1| _____________________________________________________________________________________________________________________| | CARDIOVASCULAR SYSTEM | | | |__________________________________________________________________________|____________| Blood Vessel | | 1 | |__________________________________________________________________________|____________| Heart | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Cardiomyopathy | | 2 1.0| Mineralization | | 2 1.5| _____________________________________________________________________________________________________________________| | ENDOCRINE SYSTEM | | | |__________________________________________________________________________|____________| _____________________________________________________________________________________________________________________|____________| * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 80 NTP Experiment-Test: 88122-07 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC ELMIRON Date: 04/23/01 Route: GAVAGE Time: 15:23:02 __________________________________________________________________________________________________________________________________ | 4| 7| 6| 7| 7| 7| 4| 7| 7| 7| 7| 7| 6| 7| 0| 6| 7| 7| 7| 7| 7| 7| 7| 7| 5| | DAY ON TEST | 9| 3| 6| 2| 3| 3| 9| 3| 3| 3| 3| 3| 3| 3| 1| 9| 3| 3| 3| 3| 3| 3| 3| 3| 8| | | 2| 0| 8| 1| 0| 1| 8| 1| 0| 0| 1| 1| 1| 1| 1| 5| 0| 1| 0| 0| 1| 0| 0| 0| 4| | __________________________________________|__________________________________________________________________________| 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 | B6C3F1 MICE 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| 2| A | 504 | 7| 7| 7| 7| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 0| L | MG/KG | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| | _____________________________________________________________________________________________________________________|____________| ENDOCRINE SYSTEM - cont | | | Adrenal Cortex | + + + + + + + + + + + + + + + + + + + + + + + + +| 49 | Hyperplasia | 2 2 2 2 3 3 | 13 2.3| Hypertrophy | 2 4 1 1 2 1 3 | 15 1.9| |__________________________________________________________________________|____________| Adrenal Medulla | + + + + + + + + + + + + + + + + + + + + + + + + +| 49 | Hyperplasia | 1 | 1 1.0| |__________________________________________________________________________|____________| Islets, Pancreatic | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Parathyroid Gland | + + + + + M + + + + + + + + + M + M M + + + + + +| 40 | |__________________________________________________________________________|____________| Pituitary Gland | + + + I + + + + + + + + + + + + + + + + + + + + +| 48 | Pars Distalis, Hyperplasia | 2 1 | 2 1.5| |__________________________________________________________________________|____________| Thyroid Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| 49 | Follicular Cell, Hyperplasia | | 1 1.0| _____________________________________________________________________________________________________________________| | GENERAL BODY SYSTEM | | | None | | | _____________________________________________________________________________________________________________________| | GENITAL SYSTEM | | | |__________________________________________________________________________|____________| Epididymis | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Preputial Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Ectasia | 3 3 | 3 2.7| Infiltration Cellular, Histiocyte | | 1 3.0| Inflammation, Chronic Active | 2 2 | 3 2.0| |__________________________________________________________________________|____________| Prostate | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Inflammation, Chronic Active | | 1 4.0| |__________________________________________________________________________|____________| Seminal Vesicle | + + + + + + + + + + + + + + + + + + + + + + + + +| 49 | Inflammation, Chronic Active | 2 2 | 2 2.0| _____________________________________________________________________________________________________________________|____________| * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 81 NTP Experiment-Test: 88122-07 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC ELMIRON Date: 04/23/01 Route: GAVAGE Time: 15:23:02 __________________________________________________________________________________________________________________________________ | 4| 7| 6| 7| 7| 7| 4| 7| 7| 7| 7| 7| 6| 7| 0| 6| 7| 7| 7| 7| 7| 7| 7| 7| 5| | DAY ON TEST | 9| 3| 6| 2| 3| 3| 9| 3| 3| 3| 3| 3| 3| 3| 1| 9| 3| 3| 3| 3| 3| 3| 3| 3| 8| | | 2| 0| 8| 1| 0| 1| 8| 1| 0| 0| 1| 1| 1| 1| 1| 5| 0| 1| 0| 0| 1| 0| 0| 0| 4| | __________________________________________|__________________________________________________________________________| 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 | B6C3F1 MICE 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| 2| A | 504 | 7| 7| 7| 7| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 0| L | MG/KG | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| | _____________________________________________________________________________________________________________________|____________| GENITAL SYSTEM - cont | | | |__________________________________________________________________________|____________| Testes | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Germinal Epithelium, Degeneration | | 1 2.0| _____________________________________________________________________________________________________________________| | HEMATOPOIETIC SYSTEM | | | |__________________________________________________________________________|____________| Bone Marrow | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Angiectasis | 3 | 1 3.0| |__________________________________________________________________________|____________| Lymph Node | + | 1 | Mediastinal, Infiltration Cellular, | | | Histiocyte | 1 | 1 1.0| |__________________________________________________________________________|____________| Lymph Node, Mandibular | + + M + M + M M + + M M + M + + + + + M M M + + +| 30 | |__________________________________________________________________________|____________| Lymph Node, Mesenteric | A + + M + + + + + + + + A + + A + + + + + + + + +| 41 | Infiltration Cellular, Histiocyte | 3 2 2 2 2 2 2 2 2 1 3 2 2 2 1 3 2 3| 37 2.0| |__________________________________________________________________________|____________| Spleen | + + + + + + + + + + + + + + + + + + + + + + + + +| 49 | Amyloid Deposition | 3 | 1 3.0| Hematopoietic Cell Proliferation | 2 3 1 2 1 1 1 | 15 1.8| Infiltration Cellular, Mast Cell | | 1 3.0| Infiltration Cellular, Histiocyte | 1 1 1 1 1 1 1 1 1 1 1| 23 1.0| |__________________________________________________________________________|____________| Thymus | + M + M + + M + + + + + + + + M + M + M + M M + M| 33 | _____________________________________________________________________________________________________________________| | INTEGUMENTARY SYSTEM | | | |__________________________________________________________________________|____________| Mammary Gland | 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| | |__________________________________________________________________________|____________| Skin | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Inflammation, Chronic Active | | 1 3.0| _____________________________________________________________________________________________________________________| | MUSCULOSKELETAL SYSTEM | | | _____________________________________________________________________________________________________________________|____________| * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 82 NTP Experiment-Test: 88122-07 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC ELMIRON Date: 04/23/01 Route: GAVAGE Time: 15:23:02 __________________________________________________________________________________________________________________________________ | 4| 7| 6| 7| 7| 7| 4| 7| 7| 7| 7| 7| 6| 7| 0| 6| 7| 7| 7| 7| 7| 7| 7| 7| 5| | DAY ON TEST | 9| 3| 6| 2| 3| 3| 9| 3| 3| 3| 3| 3| 3| 3| 1| 9| 3| 3| 3| 3| 3| 3| 3| 3| 8| | | 2| 0| 8| 1| 0| 1| 8| 1| 0| 0| 1| 1| 1| 1| 1| 5| 0| 1| 0| 0| 1| 0| 0| 0| 4| | __________________________________________|__________________________________________________________________________| 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 | B6C3F1 MICE 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| 2| A | 504 | 7| 7| 7| 7| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 0| L | MG/KG | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| | _____________________________________________________________________________________________________________________|____________| MUSCULOSKELETAL SYSTEM - cont | | | |__________________________________________________________________________|____________| Bone | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | |__________________________________________________________________________|____________| Skeletal Muscle | + | 1 | _____________________________________________________________________________________________________________________| | NERVOUS SYSTEM | | | |__________________________________________________________________________|____________| Brain | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Hemorrhage | 2 | 1 2.0| |__________________________________________________________________________|____________| Spinal Cord | | 1 | _____________________________________________________________________________________________________________________| | RESPIRATORY SYSTEM | | | |__________________________________________________________________________|____________| Lung | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | Hemorrhage | | 1 2.0| Mineralization | | 1 1.0| Alveolar Epithelium, Hyperplasia | 1 1 2 | 4 1.5| Alveolus, Infiltration Cellular, | | | Histiocyte | 1 | 2 2.0| Mediastinum, Hemorrhage | 3 | 1 3.0| Mediastinum, Inflammation, Acute | 3 | 1 3.0| |__________________________________________________________________________|____________| Nose | + + + + + + + + + + + + + + + A + + + + + + + + +| 47 | Inflammation, Suppurative | 1 | 2 1.0| Olfactory Epithelium, Metaplasia | | 1 1.0| |__________________________________________________________________________|____________| Pleura | + | 1 | |__________________________________________________________________________|____________| Trachea | + + + + + + + + + + + + + + + + + + + + + + + + +| 50 | _____________________________________________________________________________________________________________________| | SPECIAL SENSES SYSTEM | | | |__________________________________________________________________________|____________| Eye | +| 1 | _____________________________________________________________________________________________________________________|____________| * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 83 NTP Experiment-Test: 88122-07 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC ELMIRON Date: 04/23/01 Route: GAVAGE Time: 15:23:02 __________________________________________________________________________________________________________________________________ | 4| 7| 6| 7| 7| 7| 4| 7| 7| 7| 7| 7| 6| 7| 0| 6| 7| 7| 7| 7| 7| 7| 7| 7| 5| | DAY ON TEST | 9| 3| 6| 2| 3| 3| 9| 3| 3| 3| 3| 3| 3| 3| 1| 9| 3| 3| 3| 3| 3| 3| 3| 3| 8| | | 2| 0| 8| 1| 0| 1| 8| 1| 0| 0| 1| 1| 1| 1| 1| 5| 0| 1| 0| 0| 1| 0| 0| 0| 4| | __________________________________________|__________________________________________________________________________| 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 | B6C3F1 MICE 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| 2| A | 504 | 7| 7| 7| 7| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 0| L | MG/KG | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| | _____________________________________________________________________________________________________________________|____________| SPECIAL SENSES SYSTEM - cont | | | |__________________________________________________________________________|____________| Harderian Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| 48 | Hyperplasia | 3 | 1 3.0| |__________________________________________________________________________|____________| Zymbal's Gland | + | 1 | _____________________________________________________________________________________________________________________| | URINARY SYSTEM | | | |__________________________________________________________________________|____________| Kidney | + + + + + + + + + + + + + + + + + + + + + + + + +| 49 | Cyst | | 1 2.0| Hydronephrosis | | 1 2.0| Infiltration Cellular, Mast Cell | | 1 1.0| Inflammation, Suppurative | | 1 2.0| Nephropathy | 1 1 1 1 1 1 1 2 1 1 4 1 1 1 3 2 1 2 1 2 2| 41 1.5| |__________________________________________________________________________|____________| Urinary Bladder | + + + + + + + + + + + + + + + + + + + + + + + + +| 49 | __________________________________________________________________________________________________________________________________ * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 84 ------------------------------------------------------------ ---------- END OF REPORT ---------- ------------------------------------------------------------