TDMS Study 05007-05 Pathology Tables
NTP Experiment-Test: 05007-05 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 08:05:11 Facility: Southern Research Institute Chemical CAS #: 9005-65-6 Lock Date: None Cage Range: All Reasons For Removal: All Removal Date Range: All Treatment Groups: Include All Page 1 NTP Experiment-Test: 05007-05 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 08:05:11 _____________________________________________________________________________________________________________________ | 6| 6| 7| 7| 7| 5| 7| 7| 7| 7| 6| 6| 6| 7| 7| 6| 7| 7| 7| 7| 2| 4| 4| 4| 4| DAY ON TEST | 3| 3| 2| 2| 2| 8| 2| 2| 2| 2| 1| 8| 9| 2| 2| 0| 0| 2| 2| 2| 5| 5| 5| 5| 5| | 6| 6| 9| 9| 9| 0| 9| 9| 9| 9| 4| 3| 6| 9| 9| 9| 7| 9| 9| 9| 5| 8| 8| 8| 8| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 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| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| UNTREATD | 7| 7| 7| 7| 7| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| CONTROL | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| _____________________________________________________________________________________________________________________| ALIMENTARY SYSTEM | | | | __________________________________________________________________________| Esophagus | + + + + + + + + + + + + + + + + + + + + | __________________________________________________________________________| Gallbladder | + M + + + + + + + + + + + + + + + M + + | Infiltration Cellular, Lymphocyte | 2 2 2 2 1 2 1 | __________________________________________________________________________| Intestine Large | + + + + + A + + + + A + + + + + + + + + | __________________________________________________________________________| Intestine Large, Cecum | + + + + + A + + + + A + + + + + + + + + | Inflammation, Chronic Active | | __________________________________________________________________________| Intestine Large, Colon | + + + + + A + + + + A + + + + + + + + + | __________________________________________________________________________| Intestine Large, Rectum | + + + + + A + + + + A + + + + + + + + + | __________________________________________________________________________| Intestine Small | + + + + + A + + + + A + + + + + + + + + | __________________________________________________________________________| Intestine Small, Duodenum | + + + + + A + + + + A + + + + + + + + + | Serosa, Inflammation, Chronic Active | | __________________________________________________________________________| Intestine Small, Ileum | + + + + + A + + + + A + + + + + + + + + | Serosa, Inflammation, Chronic Active | | __________________________________________________________________________| Intestine Small, Jejunum | + + + + + A + + + + A + + + + + + + + + | Serosa, Inflammation, Chronic Active | | __________________________________________________________________________| Liver | + + + + + + + + + + + + + + + + + + + + | Fatty Change | | Focal Cellular Change | | Hematopoietic Cell Proliferation | 4 1 1 | Infiltration Cellular, Lymphocyte | 2 2 2 2 2 1 2 2 2 | Inflammation, Acute | 2 | Necrosis | 2 | Vacuolization Cytoplasmic | 2 | Hepatocyte, Hyperplasia | 2 | Serosa, Inflammation, Chronic | | __________________________________________________________________________| Mesentery | + + + + | Inflammation, Acute | 3 | Inflammation, Chronic Active | 3 | Fat, Necrosis | 2 3 | __________________________________________________________________________| Pancreas | + + + + + A + + + + A + + + + + + + + + | Abscess | | Infiltration Cellular, Lymphocyte | 2 2 2 2 2 2 2 2 2 | Inflammation, Chronic Active | | Acinus, Atrophy | 2 4 | Duct, Ectasia | 3 | __________________________________________________________________________| Salivary Glands | + + + + + + + + + + M + + + + + + + + + | Infiltration Cellular, Lymphocyte | 2 2 2 2 2 2 2 2 2 2 3 2 2 2 2 2 2 | __________________________________________________________________________| Stomach | + + + + + A + + + + + + + + + + + + + + | __________________________________________________________________________| Stomach, Forestomach | + + + + + A + + + + + + + + + + + + + + | Hyperplasia, Squamous | 1 | Infiltration Cellular, Lymphocyte | 1 | Inflammation, Acute | 2 | Inflammation, Chronic Active | | Mineralization | 1 1 | _____________________________________________________________________________________________________________________| Page 2 NTP Experiment-Test: 05007-05 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 08:05:11 _____________________________________________________________________________________________________________________ | 6| 6| 7| 7| 7| 5| 7| 7| 7| 7| 6| 6| 6| 7| 7| 6| 7| 7| 7| 7| 2| 4| 4| 4| 4| DAY ON TEST | 3| 3| 2| 2| 2| 8| 2| 2| 2| 2| 1| 8| 9| 2| 2| 0| 0| 2| 2| 2| 5| 5| 5| 5| 5| | 6| 6| 9| 9| 9| 0| 9| 9| 9| 9| 4| 3| 6| 9| 9| 9| 7| 9| 9| 9| 5| 8| 8| 8| 8| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 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| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| UNTREATD | 7| 7| 7| 7| 7| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| CONTROL | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| _____________________________________________________________________________________________________________________| ALIMENTARY SYSTEM - cont | | | | Ulcer | | __________________________________________________________________________| Stomach, Glandular | + + + + + A + + + + + + + + + + + + + + | Infiltration Cellular, Lymphocyte | 2 2 2 2 | Inflammation, Chronic Active | | Mineralization | 2 2 | Mucosa, Ectasia | | _____________________________________________________________________________________________________________________| CARDIOVASCULAR SYSTEM | | | | __________________________________________________________________________| Heart | + + + + + + + + + + + + + + + + + + + + | Infiltration Cellular, Lymphocyte | 1 2 2 2 | Inflammation, Acute | 1 | Inflammation, Chronic Active | | Ventricle, Thrombosis | X | _____________________________________________________________________________________________________________________| ENDOCRINE SYSTEM | | | | __________________________________________________________________________| Adrenal Gland | + + + + + + + + + + + + + + + + + + + + | Capsule, Inflammation, Chronic Active| | __________________________________________________________________________| Adrenal Gland, Cortex | + + + + + + + + + + + + + + + + + + + + | Congestion | | Cyst | X | Degeneration, Fatty | 2 | Hyperplasia | 2 | Inflammation, Acute | | Pigmentation | 1 2 2 2 1 2 2 2 2 2 2 2 1 2 2 | Spindle Cell, Hyperplasia | 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 3 2 2 2 | __________________________________________________________________________| Adrenal Gland, Medulla | + + + + + + + + + + + + + + + + + + + + | Hyperplasia | | __________________________________________________________________________| Islets, Pancreatic | + + + + + A + + + + A + + + + + + + + + | Infiltration Cellular, Lymphocyte | 2 | __________________________________________________________________________| Parathyroid Gland | M M + + + M + + + M + + + + M + + + M + | Infiltration Cellular, Lymphocyte | | __________________________________________________________________________| Pituitary Gland | + + + + + + + + + + + + + + + + + + + + | Congestion | 2 | Pars Distalis, Angiectasis | | Pars Distalis, Cyst | X | Pars Distalis, Hyperplasia | 2 2 2 1 | __________________________________________________________________________| Thyroid Gland | + + + + + + + + + + + + + + + + + + + + | Infiltration Cellular, Lymphocyte | 2 1 | Follicle, Ectasia | 3 2 2 | Follicle, Hyperplasia | 1 | Follicular Cell, Ectasia | 2 2 | _____________________________________________________________________________________________________________________| GENERAL BODY SYSTEM | | | | None | | _____________________________________________________________________________________________________________________| Page 3 NTP Experiment-Test: 05007-05 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 08:05:11 _____________________________________________________________________________________________________________________ | 6| 6| 7| 7| 7| 5| 7| 7| 7| 7| 6| 6| 6| 7| 7| 6| 7| 7| 7| 7| 2| 4| 4| 4| 4| DAY ON TEST | 3| 3| 2| 2| 2| 8| 2| 2| 2| 2| 1| 8| 9| 2| 2| 0| 0| 2| 2| 2| 5| 5| 5| 5| 5| | 6| 6| 9| 9| 9| 0| 9| 9| 9| 9| 4| 3| 6| 9| 9| 9| 7| 9| 9| 9| 5| 8| 8| 8| 8| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 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| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| UNTREATD | 7| 7| 7| 7| 7| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| CONTROL | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| _____________________________________________________________________________________________________________________| GENITAL SYSTEM | | | | __________________________________________________________________________| Ovary | + + + + + + + + + + M + + + + + + + + M | Abscess | 4 4 4 4 | Angiectasis | 2 | Hemorrhage | 3 | Mineralization | | Follicle, Cyst | X X | Periovarian Tissue, Cyst | X | __________________________________________________________________________| Uterus | + + + + + + + + + + + + + + + + + + + + | Abscess | 4 | Angiectasis | | Hydrometra | | Endometrium, Hyperplasia, Cystic | 3 3 4 3 3 3 3 3 3 3 3 3 3 2 3 3 3 | Endometrium, Inflammation, Acute | 3 4 3 3 | Endometrium, Metaplasia, Squamous | 2 | _____________________________________________________________________________________________________________________| HEMATOPOIETIC SYSTEM | | | | __________________________________________________________________________| Blood | | __________________________________________________________________________| Bone Marrow | + + + + + + + + + + + + + + + + + + + + | Angiectasis | | Infiltration Cellular, Lymphocyte | | Myelofibrosis | 2 2 3 3 2 2 3 3 3 | Myeloid Cell, Hyperplasia | 4 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 | __________________________________________________________________________| Lymph Node | + + + + + + + + + + M + + + + + + + + + | Iliac, Hyperplasia, Lymphoid | 3 | Mediastinal, Hyperplasia, Lymphoid | | Renal, Hyperplasia, Lymphoid | 3 | Renal, Inflammation, Acute | 3 | __________________________________________________________________________| Lymph Node, Mandibular | + + + + + + + + + + M + + + + + + + + + | Hyperplasia, Lymphoid | 2 2 2 3 2 2 3 2 2 2 2 2 2 2 2 2 | Pigmentation | 2 2 2 2 2 2 2 2 | __________________________________________________________________________| Lymph Node, Mesenteric | + + + + + + + + + + M M + + + + + + + + | Angiectasis | | Congestion | 2 | Hyperplasia, Lymphoid | 2 2 2 3 2 3 | Inflammation, Acute | 2 3 | Pigmentation | 1 | __________________________________________________________________________| Spleen | + + + + + A + + + + + + + + + + + + + + | Hematopoietic Cell Proliferation | 3 4 2 2 2 3 2 2 3 2 3 2 3 2 3 3 2 2 | Hyperplasia, Lymphoid | 2 2 2 2 2 2 2 2 | Inflammation, Acute | 3 3 | Pigmentation | 2 2 1 1 2 2 2 2 | Capsule, Inflammation, Chronic | | __________________________________________________________________________| Thymus | + + + + + + + + + + + + + + + + + + + + | Cyst | X X X X | _____________________________________________________________________________________________________________________| Page 4 NTP Experiment-Test: 05007-05 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 08:05:11 _____________________________________________________________________________________________________________________ | 6| 6| 7| 7| 7| 5| 7| 7| 7| 7| 6| 6| 6| 7| 7| 6| 7| 7| 7| 7| 2| 4| 4| 4| 4| DAY ON TEST | 3| 3| 2| 2| 2| 8| 2| 2| 2| 2| 1| 8| 9| 2| 2| 0| 0| 2| 2| 2| 5| 5| 5| 5| 5| | 6| 6| 9| 9| 9| 0| 9| 9| 9| 9| 4| 3| 6| 9| 9| 9| 7| 9| 9| 9| 5| 8| 8| 8| 8| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 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| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| UNTREATD | 7| 7| 7| 7| 7| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| CONTROL | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| _____________________________________________________________________________________________________________________| HEMATOPOIETIC SYSTEM - cont | | | | Edema | | Hyperplasia, Lymphoid | 2 2 2 2 2 3 2 | Inflammation, Acute | 3 | _____________________________________________________________________________________________________________________| INTEGUMENTARY SYSTEM | | | | __________________________________________________________________________| Mammary Gland | + + + + + + + + + + + + + + + + + + + + | Acinus, Ectasia | | Duct, Ectasia | | __________________________________________________________________________| Skin | + + + + + + + + + + + + + + + + + + + + | Inflammation, Chronic | 2 2 2 3 2 1 1 1 2 1 1 | Inflammation, Chronic Active | | Inflammation, Multifocal | | _____________________________________________________________________________________________________________________| MUSCULOSKELETAL SYSTEM | | | | __________________________________________________________________________| Bone | + + + + + + + + + + + + + + + + + + + + | _____________________________________________________________________________________________________________________| NERVOUS SYSTEM | | | | __________________________________________________________________________| Brain | + + + + + + + + + + + + + + + + + + + + | Mineralization | 1 2 2 2 2 2 2 | __________________________________________________________________________| Spinal Cord | + | _____________________________________________________________________________________________________________________| RESPIRATORY SYSTEM | | | | __________________________________________________________________________| Lung | + + + + + + + + + + + + + + + + + + + + | Abscess | | Congestion | 2 3 | Hemorrhage | 1 | Infiltration Cellular, Lymphocyte | 2 2 2 2 2 2 1 2 2 2 1 2 2 2 2 2 2 2 2 | Alveolar Epithelium, Hyperplasia | 2 2 | Alveolus, Infiltration Cellular, | | Histiocyte | 2 | Arteriole, Inflammation, Chronic | | Active | | Interstitium, Inflammation, Acute | 2 2 | Mediastinum, Atypia Cellular | | Mediastinum, Inflammation, Acute | | __________________________________________________________________________| Nose | + + + + + + + + + + M + + + + + + + + + | Lumen, Hemorrhage | 2 1 2 2 2 2 2 1 1 | Mucosa, Inflammation, Acute | | Nasolacrimal Duct, Hemorrhage | 2 2 | Olfactory Epithelium, Degeneration | 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 | Respiratory Epithelium, Degeneration | 2 | __________________________________________________________________________| Trachea | + + + + + M + + + + + + + + + + + + + + | _____________________________________________________________________________________________________________________| SPECIAL SENSES SYSTEM | | | | _____________________________________________________________________________________________________________________| Page 5 NTP Experiment-Test: 05007-05 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 08:05:11 _____________________________________________________________________________________________________________________ | 6| 6| 7| 7| 7| 5| 7| 7| 7| 7| 6| 6| 6| 7| 7| 6| 7| 7| 7| 7| 2| 4| 4| 4| 4| DAY ON TEST | 3| 3| 2| 2| 2| 8| 2| 2| 2| 2| 1| 8| 9| 2| 2| 0| 0| 2| 2| 2| 5| 5| 5| 5| 5| | 6| 6| 9| 9| 9| 0| 9| 9| 9| 9| 4| 3| 6| 9| 9| 9| 7| 9| 9| 9| 5| 8| 8| 8| 8| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 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| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| UNTREATD | 7| 7| 7| 7| 7| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| CONTROL | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| _____________________________________________________________________________________________________________________| SPECIAL SENSES SYSTEM - cont | | | | __________________________________________________________________________| Ear | | _____________________________________________________________________________________________________________________| URINARY SYSTEM | | | | __________________________________________________________________________| Kidney | + + + + + + + + + + + + + + + + + + + + | Infiltration Cellular, Lymphocyte | 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 | Inflammation, Acute | | Inflammation, Chronic | | Inflammation, Chronic Active | | Metaplasia, Osseous | | Capsule, Inflammation, Chronic Active| | Renal Tubule, Casts Protein | 1 2 1 2 | Renal Tubule, Ectasia | 1 2 1 1 1 1 2 | Renal Tubule, Mineralization | 2 | Renal Tubule, Necrosis | 1 1 2 2 1 | Renal Tubule, Regeneration | 1 2 2 2 1 1 2 1 | __________________________________________________________________________| Urinary Bladder | + + + + + A + + + + + + + + + + + + + + | Infiltration Cellular, Lymphocyte | 2 2 2 2 2 2 2 | Inflammation, Acute | | Serosa, Inflammation, Chronic Active | | _____________________________________________________________________________________________________________________| Page 6 NTP Experiment-Test: 05007-05 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 08:05:11 _____________________________________________________________________________________________________________________ | 3| 6| 6| 7| 7| 7| 7| 7| 7| 7| 5| 5| 7| 7| 7| 5| 5| 7| 7| 7| 4| 4| 4| 4| 4| DAY ON TEST | 9| 3| 5| 0| 2| 2| 2| 2| 2| 2| 5| 8| 0| 0| 3| 5| 8| 3| 3| 3| 5| 5| 5| 5| 5| | 1| 7| 3| 6| 9| 9| 9| 9| 9| 9| 9| 6| 0| 8| 0| 7| 7| 0| 0| 0| 8| 8| 8| 8| 8| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 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 | 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| UNTREATD | 2| 2| 2| 2| 2| 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| CONTROL | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| _____________________________________________________________________________________________________________________| ALIMENTARY SYSTEM | | | | __________________________________________________________________________| Esophagus | + + + + + + + + + + + + + + + + + + + + | __________________________________________________________________________| Gallbladder | + + + + + + + + + + + M + + + + + + + + | Infiltration Cellular, Lymphocyte | 2 2 2 2 1 2 2 2 2 | __________________________________________________________________________| Intestine Large | + + + + + + + + + + + + + + + + + + + + | __________________________________________________________________________| Intestine Large, Cecum | + + + + + + + + + + + + + + + + + + + + | Inflammation, Chronic Active | | __________________________________________________________________________| Intestine Large, Colon | + + + + + + + + + + + + + + + + + + + + | __________________________________________________________________________| Intestine Large, Rectum | + + + + + + + + + + + + + + + + + + + + | __________________________________________________________________________| Intestine Small | + + + + + + + + + + + + + + + + + + + + | __________________________________________________________________________| Intestine Small, Duodenum | + + + + + + + + + + + + + + + + + + + + | Serosa, Inflammation, Chronic Active | | __________________________________________________________________________| Intestine Small, Ileum | + + + + + + + + + + + + + + + + + + + + | Serosa, Inflammation, Chronic Active | | __________________________________________________________________________| Intestine Small, Jejunum | + + + + + + + + + + + + + + + + + + + + | Serosa, Inflammation, Chronic Active | | __________________________________________________________________________| Liver | + + + + + + + + + + + + + + + + + + + + | Fatty Change | 2 | Focal Cellular Change | X | Hematopoietic Cell Proliferation | 2 2 2 2 3 2 2 1 2 2 2 2 | Infiltration Cellular, Lymphocyte | 2 2 1 2 2 1 2 2 | Inflammation, Acute | 2 2 | Necrosis | 2 | Vacuolization Cytoplasmic | | Hepatocyte, Hyperplasia | | Serosa, Inflammation, Chronic | | __________________________________________________________________________| Mesentery | + + + + + | Inflammation, Acute | 3 4 4 | Inflammation, Chronic Active | | Fat, Necrosis | | __________________________________________________________________________| Pancreas | + + + + + + + + + + + + + + + + + + + + | Abscess | 4 | Infiltration Cellular, Lymphocyte | 2 2 2 2 1 1 2 1 | Inflammation, Chronic Active | | Acinus, Atrophy | | Duct, Ectasia | 3 | __________________________________________________________________________| Salivary Glands | M + + + + + + + + + + M + + + M + + + + | Infiltration Cellular, Lymphocyte | 2 2 2 2 2 2 2 2 2 2 1 2 2 2 | __________________________________________________________________________| Stomach | + + + + + + + + + + + + + + + + + + + + | __________________________________________________________________________| Stomach, Forestomach | + + + + + + + + + + + + + + + + + + + + | Hyperplasia, Squamous | 3 3 | Infiltration Cellular, Lymphocyte | | Inflammation, Acute | 2 | Inflammation, Chronic Active | 3 | Mineralization | | _____________________________________________________________________________________________________________________| Page 7 NTP Experiment-Test: 05007-05 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 08:05:11 _____________________________________________________________________________________________________________________ | 3| 6| 6| 7| 7| 7| 7| 7| 7| 7| 5| 5| 7| 7| 7| 5| 5| 7| 7| 7| 4| 4| 4| 4| 4| DAY ON TEST | 9| 3| 5| 0| 2| 2| 2| 2| 2| 2| 5| 8| 0| 0| 3| 5| 8| 3| 3| 3| 5| 5| 5| 5| 5| | 1| 7| 3| 6| 9| 9| 9| 9| 9| 9| 9| 6| 0| 8| 0| 7| 7| 0| 0| 0| 8| 8| 8| 8| 8| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 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 | 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| UNTREATD | 2| 2| 2| 2| 2| 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| CONTROL | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| _____________________________________________________________________________________________________________________| ALIMENTARY SYSTEM - cont | | | | Ulcer | | __________________________________________________________________________| Stomach, Glandular | + + + + + + + + + + + + + + + + + + + + | Infiltration Cellular, Lymphocyte | 2 2 2 2 2 2 2 2 | Inflammation, Chronic Active | 2 | Mineralization | 2 | Mucosa, Ectasia | 2 | _____________________________________________________________________________________________________________________| CARDIOVASCULAR SYSTEM | | | | __________________________________________________________________________| Heart | M + + + + + + + + + + + + + + + + + + + | Infiltration Cellular, Lymphocyte | 2 1 1 2 1 | Inflammation, Acute | 2 2 | Inflammation, Chronic Active | | Ventricle, Thrombosis | | _____________________________________________________________________________________________________________________| ENDOCRINE SYSTEM | | | | __________________________________________________________________________| Adrenal Gland | + + + + + + + + + + + + + + + + + + + + | Capsule, Inflammation, Chronic Active| | __________________________________________________________________________| Adrenal Gland, Cortex | + + + + + + + + + + + + + + + + + + + + | Congestion | 2 | Cyst | | Degeneration, Fatty | | Hyperplasia | 2 | Inflammation, Acute | 1 | Pigmentation | 2 2 2 2 2 2 2 2 2 2 2 2 | Spindle Cell, Hyperplasia | 3 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 | __________________________________________________________________________| Adrenal Gland, Medulla | + + + + + + + + + + + + + + + + + + + + | Hyperplasia | 2 | __________________________________________________________________________| Islets, Pancreatic | + + + + + + + + + + + + + + + + + + + + | Infiltration Cellular, Lymphocyte | | __________________________________________________________________________| Parathyroid Gland | + M + + M M M M M M + M + + + + M M M M | Infiltration Cellular, Lymphocyte | 2 | __________________________________________________________________________| Pituitary Gland | M + + + + + + M + + + + + + + + + + M + | Congestion | | Pars Distalis, Angiectasis | 2 | Pars Distalis, Cyst | X X X | Pars Distalis, Hyperplasia | 1 2 | __________________________________________________________________________| Thyroid Gland | + M + + + + + + + + + + + + + + + + + + | Infiltration Cellular, Lymphocyte | 2 2 | Follicle, Ectasia | 2 2 2 | Follicle, Hyperplasia | 2 | Follicular Cell, Ectasia | | _____________________________________________________________________________________________________________________| GENERAL BODY SYSTEM | | | | None | | _____________________________________________________________________________________________________________________| Page 8 NTP Experiment-Test: 05007-05 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 08:05:11 _____________________________________________________________________________________________________________________ | 3| 6| 6| 7| 7| 7| 7| 7| 7| 7| 5| 5| 7| 7| 7| 5| 5| 7| 7| 7| 4| 4| 4| 4| 4| DAY ON TEST | 9| 3| 5| 0| 2| 2| 2| 2| 2| 2| 5| 8| 0| 0| 3| 5| 8| 3| 3| 3| 5| 5| 5| 5| 5| | 1| 7| 3| 6| 9| 9| 9| 9| 9| 9| 9| 6| 0| 8| 0| 7| 7| 0| 0| 0| 8| 8| 8| 8| 8| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 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 | 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| UNTREATD | 2| 2| 2| 2| 2| 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| CONTROL | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| _____________________________________________________________________________________________________________________| GENITAL SYSTEM | | | | __________________________________________________________________________| Ovary | + + + + + + + + + + + + + + + + + + + + | Abscess | 4 4 4 4 | Angiectasis | | Hemorrhage | 3 | Mineralization | 3 | Follicle, Cyst | | Periovarian Tissue, Cyst | X X | __________________________________________________________________________| Uterus | + + + + + + + + + + + + + + + + + + + + | Abscess | 4 | Angiectasis | 2 | Hydrometra | | Endometrium, Hyperplasia, Cystic | 2 2 3 3 3 3 3 3 4 2 3 4 2 3 3 4 3 | Endometrium, Inflammation, Acute | 3 2 3 4 4 | Endometrium, Metaplasia, Squamous | | _____________________________________________________________________________________________________________________| HEMATOPOIETIC SYSTEM | | | | __________________________________________________________________________| Blood | + | __________________________________________________________________________| Bone Marrow | + + + + + + + + + + + + + + + + + + + + | Angiectasis | | Infiltration Cellular, Lymphocyte | | Myelofibrosis | 2 3 2 3 1 2 2 | Myeloid Cell, Hyperplasia | 2 2 2 2 2 4 2 2 3 2 2 2 2 2 | __________________________________________________________________________| Lymph Node | + + + + + + + + + + + + + + + + + + + + | Iliac, Hyperplasia, Lymphoid | 3 | Mediastinal, Hyperplasia, Lymphoid | 2 2 2 | Renal, Hyperplasia, Lymphoid | 3 | Renal, Inflammation, Acute | | __________________________________________________________________________| Lymph Node, Mandibular | M + + + + + + + + + + M + + + M + + + + | Hyperplasia, Lymphoid | 2 2 2 2 3 2 2 2 2 2 3 2 2 1 | Pigmentation | 1 2 2 2 2 2 2 2 | __________________________________________________________________________| Lymph Node, Mesenteric | + + + + + + + + + + + + + + + + + + + + | Angiectasis | 2 | Congestion | 3 3 | Hyperplasia, Lymphoid | 2 2 2 2 2 3 2 3 3 2 3 2 | Inflammation, Acute | 2 | Pigmentation | | __________________________________________________________________________| Spleen | + + + + + + + + + + + + + + + + + + + + | Hematopoietic Cell Proliferation | 2 3 2 2 2 2 2 4 2 2 3 3 2 3 2 4 2 1 2 | Hyperplasia, Lymphoid | 2 2 2 2 2 2 | Inflammation, Acute | 3 3 | Pigmentation | 2 1 1 1 2 2 2 1 2 2 2 2 | Capsule, Inflammation, Chronic | | __________________________________________________________________________| Thymus | M + + + + + + + + + + + + + + + + M + + | Cyst | X | _____________________________________________________________________________________________________________________| Page 9 NTP Experiment-Test: 05007-05 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 08:05:11 _____________________________________________________________________________________________________________________ | 3| 6| 6| 7| 7| 7| 7| 7| 7| 7| 5| 5| 7| 7| 7| 5| 5| 7| 7| 7| 4| 4| 4| 4| 4| DAY ON TEST | 9| 3| 5| 0| 2| 2| 2| 2| 2| 2| 5| 8| 0| 0| 3| 5| 8| 3| 3| 3| 5| 5| 5| 5| 5| | 1| 7| 3| 6| 9| 9| 9| 9| 9| 9| 9| 6| 0| 8| 0| 7| 7| 0| 0| 0| 8| 8| 8| 8| 8| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 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 | 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| UNTREATD | 2| 2| 2| 2| 2| 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| CONTROL | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| _____________________________________________________________________________________________________________________| HEMATOPOIETIC SYSTEM - cont | | | | Edema | | Hyperplasia, Lymphoid | 3 3 2 2 2 2 2 | Inflammation, Acute | 3 | _____________________________________________________________________________________________________________________| INTEGUMENTARY SYSTEM | | | | __________________________________________________________________________| Mammary Gland | M + + + + + + + + + + + + + + + + + + + | Acinus, Ectasia | 2 2 3 2 | Duct, Ectasia | 3 | __________________________________________________________________________| Skin | + + + + + + + + + + + + + + + + + + + + | Inflammation, Chronic | 1 1 1 | Inflammation, Chronic Active | | Inflammation, Multifocal | | _____________________________________________________________________________________________________________________| MUSCULOSKELETAL SYSTEM | | | | __________________________________________________________________________| Bone | + + + + + + + + + + + + + + + + + + + + | _____________________________________________________________________________________________________________________| NERVOUS SYSTEM | | | | __________________________________________________________________________| Brain | + + + + + + + + + + + + + + + + + + + + | Mineralization | 2 2 1 2 2 2 2 2 2 1 2 | __________________________________________________________________________| Spinal Cord | | _____________________________________________________________________________________________________________________| RESPIRATORY SYSTEM | | | | __________________________________________________________________________| Lung | + + + + + + + + + + + + + + + + + + + + | Abscess | 4 | Congestion | | Hemorrhage | 2 | Infiltration Cellular, Lymphocyte | 2 2 2 2 2 2 2 2 2 2 1 1 2 2 1 2 2 2 2 | Alveolar Epithelium, Hyperplasia | | Alveolus, Infiltration Cellular, | | Histiocyte | 2 2 | Arteriole, Inflammation, Chronic | | Active | 2 | Interstitium, Inflammation, Acute | | Mediastinum, Atypia Cellular | X | Mediastinum, Inflammation, Acute | 3 | __________________________________________________________________________| Nose | + + + + + + + + + + + + + + + + + + + + | Lumen, Hemorrhage | 2 2 1 1 1 | Mucosa, Inflammation, Acute | 1 | Nasolacrimal Duct, Hemorrhage | 2 2 2 1 | Olfactory Epithelium, Degeneration | 2 2 2 2 2 2 2 2 2 2 2 2 2 3 2 2 2 2 2 | Respiratory Epithelium, Degeneration | 2 | __________________________________________________________________________| Trachea | + + + + + + + + + + + + + + + + + + + + | _____________________________________________________________________________________________________________________| SPECIAL SENSES SYSTEM | | | | _____________________________________________________________________________________________________________________| Page 10 NTP Experiment-Test: 05007-05 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 08:05:11 _____________________________________________________________________________________________________________________ | 3| 6| 6| 7| 7| 7| 7| 7| 7| 7| 5| 5| 7| 7| 7| 5| 5| 7| 7| 7| 4| 4| 4| 4| 4| DAY ON TEST | 9| 3| 5| 0| 2| 2| 2| 2| 2| 2| 5| 8| 0| 0| 3| 5| 8| 3| 3| 3| 5| 5| 5| 5| 5| | 1| 7| 3| 6| 9| 9| 9| 9| 9| 9| 9| 6| 0| 8| 0| 7| 7| 0| 0| 0| 8| 8| 8| 8| 8| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 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 | 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| UNTREATD | 2| 2| 2| 2| 2| 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| CONTROL | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| _____________________________________________________________________________________________________________________| SPECIAL SENSES SYSTEM - cont | | | | __________________________________________________________________________| Ear | + | _____________________________________________________________________________________________________________________| URINARY SYSTEM | | | | __________________________________________________________________________| Kidney | + + + + + + + + + + + + + + + + + + + + | Infiltration Cellular, Lymphocyte | 2 2 2 2 2 2 1 2 2 2 2 1 2 2 2 | Inflammation, Acute | 4 | Inflammation, Chronic | 4 | Inflammation, Chronic Active | | Metaplasia, Osseous | 3 | Capsule, Inflammation, Chronic Active| | Renal Tubule, Casts Protein | 3 2 2 2 | Renal Tubule, Ectasia | 3 2 1 2 1 2 1 1 | Renal Tubule, Mineralization | | Renal Tubule, Necrosis | 3 1 1 1 | Renal Tubule, Regeneration | 2 1 | __________________________________________________________________________| Urinary Bladder | + + + + + + + + + + + + + + + + + + + + | Infiltration Cellular, Lymphocyte | 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 | Inflammation, Acute | 3 | Serosa, Inflammation, Chronic Active | | _____________________________________________________________________________________________________________________| Page 11 NTP Experiment-Test: 05007-05 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 08:05:11 __________________________________________________________________________________________________________________________________ | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| | | DAY ON TEST | 3| 3| 3| 3| 3| 0| 0| 3| 3| 3| | | | 0| 0| 0| 0| 0| 7| 7| 0| 0| 0| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | B6C3F1 MICE FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| | A | UNTREATD | 7| 7| 7| 7| 7| 8| 8| 8| 8| 8| | L | CONTROL | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| | | __________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM | | | | | | __________________________________________________________________________|____________| Esophagus | + + + + + M + + + + | 49 | __________________________________________________________________________|____________| Gallbladder | + + + + + M + + + + | 46 | Infiltration Cellular, Lymphocyte | 2 2 2 2 | 20 1.9| __________________________________________________________________________|____________| Intestine Large | + + + + + + + + + + | 48 | __________________________________________________________________________|____________| Intestine Large, Cecum | + + + + + + + + + + | 48 | Inflammation, Chronic Active | 3 | 1 3.0| __________________________________________________________________________|____________| Intestine Large, Colon | + + + + + + + + + + | 48 | __________________________________________________________________________|____________| Intestine Large, Rectum | + + + + + + + + + + | 48 | __________________________________________________________________________|____________| Intestine Small | + + + + + + + + + + | 48 | __________________________________________________________________________|____________| Intestine Small, Duodenum | + + + + + + + + + + | 48 | Serosa, Inflammation, Chronic Active | 3 | 1 3.0| __________________________________________________________________________|____________| Intestine Small, Ileum | + + + + + + + + M + | 47 | Serosa, Inflammation, Chronic Active | 2 | 1 2.0| __________________________________________________________________________|____________| Intestine Small, Jejunum | + + + + + + + + + + | 48 | Serosa, Inflammation, Chronic Active | 2 | 1 2.0| __________________________________________________________________________|____________| Liver | + + + + + + + + + + | 50 | Fatty Change | 2 | 2 2.0| Focal Cellular Change | | 1 | Hematopoietic Cell Proliferation | 2 2 2 2 1 | 20 2.0| Infiltration Cellular, Lymphocyte | 2 2 2 2 2 1 | 23 1.8| Inflammation, Acute | | 3 2.0| Necrosis | | 2 2.0| Vacuolization Cytoplasmic | 2 | 2 2.0| Hepatocyte, Hyperplasia | | 1 2.0| Serosa, Inflammation, Chronic | 2 | 1 2.0| __________________________________________________________________________|____________| Mesentery | + | 10 | Inflammation, Acute | | 4 3.5| Inflammation, Chronic Active | 4 | 2 3.5| Fat, Necrosis | | 2 2.5| __________________________________________________________________________|____________| Pancreas | + + + + + + + + + M | 47 | Abscess | | 1 4.0| Infiltration Cellular, Lymphocyte | 1 2 2 2 | 21 1.8| Inflammation, Chronic Active | 4 | 1 4.0| Acinus, Atrophy | | 2 3.0| Duct, Ectasia | | 2 3.0| __________________________________________________________________________|____________| Salivary Glands | + + + + + + + + + + | 46 | Infiltration Cellular, Lymphocyte | 2 2 2 2 2 1 1 2 2 | 40 2.0| __________________________________________________________________________|____________| Stomach | + + + + + + + + + + | 49 | __________________________________________________________________________|____________| Stomach, Forestomach | + + + + + + + + + + | 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 12 NTP Experiment-Test: 05007-05 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 08:05:11 __________________________________________________________________________________________________________________________________ | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| | | DAY ON TEST | 3| 3| 3| 3| 3| 0| 0| 3| 3| 3| | | | 0| 0| 0| 0| 0| 7| 7| 0| 0| 0| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | B6C3F1 MICE FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| | A | UNTREATD | 7| 7| 7| 7| 7| 8| 8| 8| 8| 8| | L | CONTROL | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| | | __________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - cont | | | | | | Hyperplasia, Squamous | 2 | 4 2.3| Infiltration Cellular, Lymphocyte | | 1 1.0| Inflammation, Acute | | 2 2.0| Inflammation, Chronic Active | 2 | 2 2.5| Mineralization | | 2 1.0| Ulcer | 1 | 1 1.0| __________________________________________________________________________|____________| Stomach, Glandular | + + + + + + + + + + | 49 | Infiltration Cellular, Lymphocyte | 2 2 2 | 15 2.0| Inflammation, Chronic Active | | 1 2.0| Mineralization | | 3 2.0| Mucosa, Ectasia | | 1 2.0| _____________________________________________________________________________________________________________________| | CARDIOVASCULAR SYSTEM | | | | | | __________________________________________________________________________|____________| Heart | + + + + + + + + + + | 49 | Infiltration Cellular, Lymphocyte | | 9 1.6| Inflammation, Acute | | 3 1.7| Inflammation, Chronic Active | 2 | 1 2.0| Ventricle, Thrombosis | | 1 | _____________________________________________________________________________________________________________________| | ENDOCRINE SYSTEM | | | | | | __________________________________________________________________________|____________| Adrenal Gland | + + + + + + + + + + | 50 | Capsule, Inflammation, Chronic Active| 4 | 1 4.0| __________________________________________________________________________|____________| Adrenal Gland, Cortex | + + + + + + + + + + | 50 | Congestion | | 1 2.0| Cyst | | 1 | Degeneration, Fatty | 3 3 | 3 2.7| Hyperplasia | | 2 2.0| Inflammation, Acute | 3 | 2 2.0| Pigmentation | 2 2 2 1 1 1 2 1 | 35 1.8| Spindle Cell, Hyperplasia | 2 2 2 2 2 2 2 2 2 2 | 50 2.0| __________________________________________________________________________|____________| Adrenal Gland, Medulla | + + + + + + + + + + | 50 | Hyperplasia | 2 | 2 2.0| __________________________________________________________________________|____________| Islets, Pancreatic | + + + + + + + + + M | 47 | Infiltration Cellular, Lymphocyte | | 1 2.0| __________________________________________________________________________|____________| Parathyroid Gland | + M M + + + M M M M | 26 | Infiltration Cellular, Lymphocyte | | 1 2.0| __________________________________________________________________________|____________| Pituitary Gland | + + + M + + + + + + | 46 | Congestion | | 1 2.0| Pars Distalis, 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 13 NTP Experiment-Test: 05007-05 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 08:05:11 __________________________________________________________________________________________________________________________________ | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| | | DAY ON TEST | 3| 3| 3| 3| 3| 0| 0| 3| 3| 3| | | | 0| 0| 0| 0| 0| 7| 7| 0| 0| 0| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | B6C3F1 MICE FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| | A | UNTREATD | 7| 7| 7| 7| 7| 8| 8| 8| 8| 8| | L | CONTROL | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| | | __________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM - cont | | | | | | Pars Distalis, Cyst | | 4 | Pars Distalis, Hyperplasia | 2 2 | 8 1.8| __________________________________________________________________________|____________| Thyroid Gland | + + + + + + + + + + | 49 | Infiltration Cellular, Lymphocyte | 2 2 2 1 | 8 1.8| Follicle, Ectasia | 2 2 | 8 2.1| Follicle, Hyperplasia | 2 | 3 1.7| Follicular Cell, Ectasia | | 2 2.0| _____________________________________________________________________________________________________________________| | GENERAL BODY SYSTEM | | | | | | None | | | _____________________________________________________________________________________________________________________| | GENITAL SYSTEM | | | | | | __________________________________________________________________________|____________| Ovary | + + + + + + + + + + | 48 | Abscess | 4 | 9 4.0| Angiectasis | | 1 2.0| Hemorrhage | | 2 3.0| Mineralization | | 1 3.0| Follicle, Cyst | X | 3 | Periovarian Tissue, Cyst | X X | 5 | __________________________________________________________________________|____________| Uterus | + + + + + + + + + + | 50 | Abscess | | 2 4.0| Angiectasis | | 1 2.0| Hydrometra | 3 | 1 3.0| Endometrium, Hyperplasia, Cystic | 3 4 3 3 2 3 3 3 2 3 | 44 3.0| Endometrium, Inflammation, Acute | | 9 3.2| Endometrium, Metaplasia, Squamous | | 1 2.0| _____________________________________________________________________________________________________________________| | HEMATOPOIETIC SYSTEM | | | | | | __________________________________________________________________________|____________| Blood | | 1 | __________________________________________________________________________|____________| Bone Marrow | + + + + + + + + + + | 50 | Angiectasis | 3 | 1 3.0| Infiltration Cellular, Lymphocyte | 2 | 1 2.0| Myelofibrosis | 1 3 2 2 2 | 21 2.3| Myeloid Cell, Hyperplasia | 2 2 2 2 | 34 2.1| __________________________________________________________________________|____________| Lymph Node | + + + + + + + + + + | 49 | Iliac, Hyperplasia, Lymphoid | | 2 3.0| Mediastinal, Hyperplasia, Lymphoid | | 3 2.0| Renal, Hyperplasia, Lymphoid | | 2 3.0| Renal, Inflammation, Acute | | 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 14 NTP Experiment-Test: 05007-05 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 08:05:11 __________________________________________________________________________________________________________________________________ | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| | | DAY ON TEST | 3| 3| 3| 3| 3| 0| 0| 3| 3| 3| | | | 0| 0| 0| 0| 0| 7| 7| 0| 0| 0| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | B6C3F1 MICE FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| | A | UNTREATD | 7| 7| 7| 7| 7| 8| 8| 8| 8| 8| | L | CONTROL | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| | | __________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - cont | | | | | | __________________________________________________________________________|____________| Lymph Node, Mandibular | + + + + + + + + + + | 46 | Hyperplasia, Lymphoid | 2 2 2 2 3 2 3 2 2 | 39 2.1| Pigmentation | 2 2 2 2 2 2 2 2 | 24 2.0| __________________________________________________________________________|____________| Lymph Node, Mesenteric | + + + + + + + + + + | 48 | Angiectasis | | 1 2.0| Congestion | 4 | 4 3.0| Hyperplasia, Lymphoid | 2 2 2 2 2 2 | 24 2.3| Inflammation, Acute | 3 | 4 2.5| Pigmentation | | 1 1.0| __________________________________________________________________________|____________| Spleen | + + + + + + + + + + | 49 | Hematopoietic Cell Proliferation | 2 2 2 2 4 3 2 3 2 | 46 2.4| Hyperplasia, Lymphoid | 2 2 2 2 2 | 19 2.0| Inflammation, Acute | | 4 3.0| Pigmentation | 2 1 2 2 2 2 2 2 | 28 1.8| Capsule, Inflammation, Chronic | 3 | 1 3.0| __________________________________________________________________________|____________| Thymus | + + + + + + + + + + | 48 | Cyst | X | 6 | Edema | 2 | 1 2.0| Hyperplasia, Lymphoid | 2 2 3 3 | 18 2.3| Inflammation, Acute | | 2 3.0| _____________________________________________________________________________________________________________________| | INTEGUMENTARY SYSTEM | | | | | | __________________________________________________________________________|____________| Mammary Gland | + + + + + + + + + + | 49 | Acinus, Ectasia | 2 2 1 2 1 | 9 1.9| Duct, Ectasia | | 1 3.0| __________________________________________________________________________|____________| Skin | + + + + + + + + + + | 50 | Inflammation, Chronic | 2 2 1 1 | 18 1.5| Inflammation, Chronic Active | 2 | 1 2.0| Inflammation, Multifocal | 3 | 1 3.0| _____________________________________________________________________________________________________________________| | MUSCULOSKELETAL SYSTEM | | | | | | __________________________________________________________________________|____________| Bone | + + + + + + + + + + | 50 | _____________________________________________________________________________________________________________________| | NERVOUS SYSTEM | | | | | | __________________________________________________________________________|____________| Brain | + + + + + + + + + + | 50 | Mineralization | 2 2 2 2 1 2 2 2 | 26 1.8| __________________________________________________________________________|____________| Spinal Cord | | 1 | _____________________________________________________________________________________________________________________| | 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 15 NTP Experiment-Test: 05007-05 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 08:05:11 __________________________________________________________________________________________________________________________________ | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| | | DAY ON TEST | 3| 3| 3| 3| 3| 0| 0| 3| 3| 3| | | | 0| 0| 0| 0| 0| 7| 7| 0| 0| 0| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | B6C3F1 MICE FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| | A | UNTREATD | 7| 7| 7| 7| 7| 8| 8| 8| 8| 8| | L | CONTROL | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| | | __________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM - cont | | | | | | __________________________________________________________________________|____________| Lung | + + + + + + + + + + | 50 | Abscess | | 1 4.0| Congestion | | 2 2.5| Hemorrhage | | 2 1.5| Infiltration Cellular, Lymphocyte | 2 2 2 2 2 2 2 1 2 2 | 48 1.9| Alveolar Epithelium, Hyperplasia | | 2 2.0| Alveolus, Infiltration Cellular, | | | Histiocyte | 2 | 4 2.0| Arteriole, Inflammation, Chronic | | | Active | | 1 2.0| Interstitium, Inflammation, Acute | | 2 2.0| Mediastinum, Atypia Cellular | | 1 | Mediastinum, Inflammation, Acute | | 1 3.0| __________________________________________________________________________|____________| Nose | + + + + + + + + + + | 49 | Lumen, Hemorrhage | 1 2 1 2 2 1 | 20 1.6| Mucosa, Inflammation, Acute | | 1 1.0| Nasolacrimal Duct, Hemorrhage | 2 | 7 1.9| Olfactory Epithelium, Degeneration | 2 2 2 2 2 2 2 2 2 1 | 48 2.0| Respiratory Epithelium, Degeneration | | 2 2.0| __________________________________________________________________________|____________| Trachea | + + + + + + + + + + | 49 | _____________________________________________________________________________________________________________________| | SPECIAL SENSES SYSTEM | | | | | | __________________________________________________________________________|____________| Ear | | 1 | _____________________________________________________________________________________________________________________| | URINARY SYSTEM | | | | | | __________________________________________________________________________|____________| Kidney | + + + + + + + + + + | 50 | Infiltration Cellular, Lymphocyte | 2 2 2 2 2 3 2 2 2 2 | 43 2.0| Inflammation, Acute | | 1 4.0| Inflammation, Chronic | | 1 4.0| Inflammation, Chronic Active | 4 | 1 4.0| Metaplasia, Osseous | 3 3 | 3 3.0| Capsule, Inflammation, Chronic Active| 2 | 1 2.0| Renal Tubule, Casts Protein | 1 1 1 1 | 12 1.6| Renal Tubule, Ectasia | 1 1 2 1 2 | 20 1.5| Renal Tubule, Mineralization | 1 | 2 1.5| Renal Tubule, Necrosis | 1 2 1 1 3 1 1 | 16 1.4| Renal Tubule, Regeneration | 2 1 1 3 2 | 15 1.6| __________________________________________________________________________|____________| Urinary Bladder | + + + + + + + + + + | 49 | Infiltration Cellular, Lymphocyte | 2 2 2 2 2 2 2 2 | 32 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 16 NTP Experiment-Test: 05007-05 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 08:05:11 __________________________________________________________________________________________________________________________________ | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| | | DAY ON TEST | 3| 3| 3| 3| 3| 0| 0| 3| 3| 3| | | | 0| 0| 0| 0| 0| 7| 7| 0| 0| 0| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | B6C3F1 MICE FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| | A | UNTREATD | 7| 7| 7| 7| 7| 8| 8| 8| 8| 8| | L | CONTROL | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| | | __________________________________________________________________________________________________________________________________ URINARY SYSTEM - cont | | | | | | Inflammation, Acute | | 1 3.0| Serosa, Inflammation, Chronic Active | 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 17 NTP Experiment-Test: 05007-05 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 08:05:11 _____________________________________________________________________________________________________________________ | 5| 7| 7| 7| 7| 5| 5| 7| 7| 7| 4| 4| 6| 7| 7| 4| 4| 4| 4| 4| 3| 3| 5| 6| 7| DAY ON TEST | 8| 3| 3| 3| 3| 4| 7| 0| 3| 3| 3| 6| 2| 0| 3| 5| 5| 5| 5| 5| 6| 7| 8| 9| 3| | 1| 0| 0| 0| 0| 8| 7| 2| 1| 1| 8| 9| 4| 2| 1| 8| 8| 8| 8| 8| 1| 8| 4| 4| 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 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 | 4| 4| 4| 4| 4| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5.0% | 9| 9| 9| 9| 9| 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 3| 3| 3| 3| 3| | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| _____________________________________________________________________________________________________________________| ALIMENTARY SYSTEM | | | | __________________________________________________________________________| Esophagus | + + + + + + + + + + + + + + + + M + + +| __________________________________________________________________________| Gallbladder | + + + + + + + + + + + M + + + + M + + +| Infiltration Cellular, Lymphocyte | 1 2 2 1 2 | __________________________________________________________________________| Intestine Large | + + + + + + + + + + + + + + + + A + + +| __________________________________________________________________________| Intestine Large, Cecum | + + + + + + + + + + M + + + + + A + + +| __________________________________________________________________________| Intestine Large, Colon | + + + + + + + + + + + + + + + + A + + +| __________________________________________________________________________| Intestine Large, Rectum | + + + + + + + + + + + + + + + + A + + +| __________________________________________________________________________| Intestine Small | + + + + + + + + + + + + + + + + A + + +| __________________________________________________________________________| Intestine Small, Duodenum | + + + + + + + + + + + + + + + + A + + +| __________________________________________________________________________| Intestine Small, Ileum | + + + + + + + M + + M + + + + + A + + +| __________________________________________________________________________| Intestine Small, Jejunum | + + + + + + + + + + + + + + + + A + + +| __________________________________________________________________________| Liver | + + + + + + + + + + + + + + + + A + + +| Cytomegaly | 3 | Focal Cellular Change | | Hematopoietic Cell Proliferation | 2 1 1 1 3 2 3 4 1 2| Infiltration Cellular, Lymphocyte | 2 2 2 1 2 2 1 1 2 2 | Inflammation, Acute | 2 | Necrosis | | Serosa, Inflammation, Acute | 3 | __________________________________________________________________________| Mesentery | + + + + + +| Inflammation, Acute | 3 3 4 4| Inflammation, Chronic Active | 3 | __________________________________________________________________________| Pancreas | + + + + + + + + + + + + + + + + M + + +| Infiltration Cellular, Lymphocyte | 2 2 2 1 | Inflammation, Acute | 2| Inflammation, Chronic | | Inflammation, Chronic Active | 4 | Duct, Cyst | X | __________________________________________________________________________| Salivary Glands | + + + + + + + + + + M + + + + + M + + +| Infiltration Cellular, Lymphocyte | 2 2 2 2 2 2 2 2 2 2 2 2 2 2| Acinus, Atrophy | | __________________________________________________________________________| Stomach | + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Stomach, Forestomach | + + + + + + + + + + + + + + + + + + + +| Erosion | | Hyperplasia, Squamous | 2 2 3 3 2 2 2 2 2 2 3 | Infiltration Cellular, Lymphocyte | 2 2 | Inflammation, Acute | 2 2 2 | Inflammation, Chronic Active | 2 2 2 3 2 | Inflammation, Subacute | | Ulcer | 4 3 2 4 | __________________________________________________________________________| Stomach, Glandular | + + + + + + + + + + + + + + + + + + + +| Infiltration Cellular, Lymphocyte | 2 2 2 | Inflammation, Acute | | Inflammation, Chronic Active | 2 | _____________________________________________________________________________________________________________________| Page 18 NTP Experiment-Test: 05007-05 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 08:05:11 _____________________________________________________________________________________________________________________ | 5| 7| 7| 7| 7| 5| 5| 7| 7| 7| 4| 4| 6| 7| 7| 4| 4| 4| 4| 4| 3| 3| 5| 6| 7| DAY ON TEST | 8| 3| 3| 3| 3| 4| 7| 0| 3| 3| 3| 6| 2| 0| 3| 5| 5| 5| 5| 5| 6| 7| 8| 9| 3| | 1| 0| 0| 0| 0| 8| 7| 2| 1| 1| 8| 9| 4| 2| 1| 8| 8| 8| 8| 8| 1| 8| 4| 4| 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 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 | 4| 4| 4| 4| 4| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5.0% | 9| 9| 9| 9| 9| 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 3| 3| 3| 3| 3| | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| _____________________________________________________________________________________________________________________| ALIMENTARY SYSTEM - cont | | | | Mucosa, Inflammation, Acute | 2 | __________________________________________________________________________| Tooth | | _____________________________________________________________________________________________________________________| CARDIOVASCULAR SYSTEM | | | | __________________________________________________________________________| Heart | + + + + + + + + + + + + + + + + + + + +| Embolus Bacterial | 4 | Infiltration Cellular, Lymphocyte | 1 2 1 1 | Inflammation, Acute | 2 3 | Inflammation, Chronic | | Epicardium, Inflammation, Acute | 2 | _____________________________________________________________________________________________________________________| ENDOCRINE SYSTEM | | | | __________________________________________________________________________| Adrenal Gland | + + + + + + + + + + + + + + + + + + + +| Capsule, Inflammation, Acute | 3 | __________________________________________________________________________| Adrenal Gland, Cortex | + + + + + + + + + + + + + + + + + + + +| Congestion | 3 2 | Degeneration, Fatty | | Inflammation, Acute | 2 | Pigmentation | 2 2 2 2 1 1 2 2 2 1 2 2 1| Spindle Cell, Hyperplasia | 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2| __________________________________________________________________________| Adrenal Gland, Medulla | + + + + + + + + + + + + + + + + + + + +| Hyperplasia | 2 | __________________________________________________________________________| Islets, Pancreatic | + + + + + + + + + + + + + + + + M + + +| Inflammation, Chronic | | __________________________________________________________________________| Parathyroid Gland | M + + M + + M M M + + + M + M + M M + +| __________________________________________________________________________| Pituitary Gland | + + + + + + + + + + + + + + + + M + + +| Pars Distalis, Cyst | X| Pars Distalis, Hyperplasia | 2 2 2 3 | __________________________________________________________________________| Thyroid Gland | + + + + + + + + + + + + + + + + M + + +| Infiltration Cellular, Lymphocyte | 2 1 2| Inflammation, Chronic | | Follicle, Ectasia | 2 2| Follicle, Hyperplasia | | _____________________________________________________________________________________________________________________| GENERAL BODY SYSTEM | | | | None | | _____________________________________________________________________________________________________________________| GENITAL SYSTEM | | | | __________________________________________________________________________| Ovary | + + + + + + + + + + + + + + + + + + + +| Abscess | 4 4 4 4 4 4| Hemorrhage | 4 | Mineralization | | Follicle, Cyst | X X | Periovarian Tissue, Cyst | X X | _____________________________________________________________________________________________________________________| Page 19 NTP Experiment-Test: 05007-05 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 08:05:11 _____________________________________________________________________________________________________________________ | 5| 7| 7| 7| 7| 5| 5| 7| 7| 7| 4| 4| 6| 7| 7| 4| 4| 4| 4| 4| 3| 3| 5| 6| 7| DAY ON TEST | 8| 3| 3| 3| 3| 4| 7| 0| 3| 3| 3| 6| 2| 0| 3| 5| 5| 5| 5| 5| 6| 7| 8| 9| 3| | 1| 0| 0| 0| 0| 8| 7| 2| 1| 1| 8| 9| 4| 2| 1| 8| 8| 8| 8| 8| 1| 8| 4| 4| 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 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 | 4| 4| 4| 4| 4| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5.0% | 9| 9| 9| 9| 9| 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 3| 3| 3| 3| 3| | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| _____________________________________________________________________________________________________________________| GENITAL SYSTEM - cont | | | | __________________________________________________________________________| Uterus | + + + + + + + + + + + + + + + + + + + +| Abscess | | Angiectasis | 2 | Hydrometra | | Endometrium, Abscess | 4| Endometrium, Hyperplasia, Cystic | 2 4 3 4 3 2 2 2 4 2 2 2 3 3 4 3 3 3| Endometrium, Inflammation, Acute | 2 4 2 2 4 | Endometrium, Metaplasia, Squamous | | __________________________________________________________________________| Vagina | + + | _____________________________________________________________________________________________________________________| HEMATOPOIETIC SYSTEM | | | | __________________________________________________________________________| Bone Marrow | + + + + + + + + + + + + + + + + + + + +| Myelofibrosis | 1 2 2 4 | Myeloid Cell, Hyperplasia | 2 2 2 2 2 2 2 2 2 2 2 4 3 2 4| __________________________________________________________________________| Lymph Node | + + + + + + + + + + + + + + + + M + + +| Mediastinal, Hyperplasia, Lymphoid | 2 2 3| Mediastinal, Inflammation, Acute | 4 | Renal, Hyperplasia, Lymphoid | 3 3 3 | Renal, Inflammation, Acute | 3 | __________________________________________________________________________| Lymph Node, Mandibular | + + + + + + + + + + M + + + + + M + + +| Congestion | | Hyperplasia, Lymphoid | 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2| Inflammation, Acute | | Pigmentation | 2 2 2 1 2 2 2 2 2 | __________________________________________________________________________| Lymph Node, Mesenteric | + + + + + + + + + + + + + + + + M + + +| Congestion | 2 | Hyperplasia, Lymphoid | 2 2 2 3 2 2 2 2 3 2 2 2 2 2 2| Inflammation, Acute | 3 2 | Pigmentation | | __________________________________________________________________________| Spleen | + + + + + + + + + + + + + + + + M + + +| Hematopoietic Cell Proliferation | 4 2 2 2 4 4 3 2 2 3 4 4 2 3 4| Hyperplasia, Lymphoid | 2 2 2 2 2 2 2 | Inflammation, Acute | 3 2 3 | Pigmentation | 2 2 2 2 2 2 2 2 | __________________________________________________________________________| Thymus | + + + + + + + + + + + + + + + + M M + +| Cyst | X X X | Hyperplasia, Lymphoid | 2 2 2 | Inflammation, Acute | 3 | _____________________________________________________________________________________________________________________| INTEGUMENTARY SYSTEM | | | | __________________________________________________________________________| Mammary Gland | + + + + + + + + + + + + + + + M M + + +| Acinus, Ectasia | 1 2 2 2 2 | Duct, Ectasia | 2 2| __________________________________________________________________________| Skin | + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| Page 20 NTP Experiment-Test: 05007-05 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 08:05:11 _____________________________________________________________________________________________________________________ | 5| 7| 7| 7| 7| 5| 5| 7| 7| 7| 4| 4| 6| 7| 7| 4| 4| 4| 4| 4| 3| 3| 5| 6| 7| DAY ON TEST | 8| 3| 3| 3| 3| 4| 7| 0| 3| 3| 3| 6| 2| 0| 3| 5| 5| 5| 5| 5| 6| 7| 8| 9| 3| | 1| 0| 0| 0| 0| 8| 7| 2| 1| 1| 8| 9| 4| 2| 1| 8| 8| 8| 8| 8| 1| 8| 4| 4| 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 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 | 4| 4| 4| 4| 4| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5.0% | 9| 9| 9| 9| 9| 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 3| 3| 3| 3| 3| | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| _____________________________________________________________________________________________________________________| INTEGUMENTARY SYSTEM - cont | | | | Inflammation, Chronic | 2 2 2 2 2 | Inflammation, Chronic Active | | _____________________________________________________________________________________________________________________| MUSCULOSKELETAL SYSTEM | | | | __________________________________________________________________________| Bone | + + + + + + + + + + + + + + + + + + + +| Cranium, Inflammation, Chronic | 3 | __________________________________________________________________________| Skeletal Muscle | + | _____________________________________________________________________________________________________________________| NERVOUS SYSTEM | | | | __________________________________________________________________________| Brain | + + + + + + + + + + + + + + + + + + + +| Compression | X | Gliosis | 2 | Hemorrhage | | Hydrocephalus | 3 | Infiltration Cellular, Lymphocyte | 2 | Mineralization | 2 2 1 2 2 2 2 2 2 2 2| Meninges, Hemorrhage | | Meninges, Inflammation, Chronic | | __________________________________________________________________________| Spinal Cord | | _____________________________________________________________________________________________________________________| RESPIRATORY SYSTEM | | | | __________________________________________________________________________| Lung | + + + + + + + + + + + + + + + + + + + +| Congestion | 3 | Hemorrhage | | Infiltration Cellular, Lymphocyte | 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2| Alveolar Epithelium, Hyperplasia | | Alveolus, Infiltration Cellular, | | Histiocyte | | Bronchiole, Inflammation, Acute | 2 | Interstitium, Inflammation, Acute | 2 3 2 | Interstitium, Inflammation, Chronic | | Interstitium, Inflammation, Chronic | | Active | | Mediastinum, Inflammation, Acute | 4 | Peribronchial, Inflammation, Acute | 4 | Pleura, Inflammation, Acute | | __________________________________________________________________________| Nose | + + + + + + + + + + + + + + + + + + + +| Lumen, Hemorrhage | 1 3 2 | Nasolacrimal Duct, Hemorrhage | 2 2 2 1 | Nasolacrimal Duct, Inflammation, | | Acute | | Olfactory Epithelium, Degeneration | 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2| __________________________________________________________________________| Trachea | + + + + + + + + + + + + + + + + M + + +| _____________________________________________________________________________________________________________________| SPECIAL SENSES SYSTEM | | _____________________________________________________________________________________________________________________| Page 21 NTP Experiment-Test: 05007-05 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 08:05:11 _____________________________________________________________________________________________________________________ | 5| 7| 7| 7| 7| 5| 5| 7| 7| 7| 4| 4| 6| 7| 7| 4| 4| 4| 4| 4| 3| 3| 5| 6| 7| DAY ON TEST | 8| 3| 3| 3| 3| 4| 7| 0| 3| 3| 3| 6| 2| 0| 3| 5| 5| 5| 5| 5| 6| 7| 8| 9| 3| | 1| 0| 0| 0| 0| 8| 7| 2| 1| 1| 8| 9| 4| 2| 1| 8| 8| 8| 8| 8| 1| 8| 4| 4| 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 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 | 4| 4| 4| 4| 4| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5.0% | 9| 9| 9| 9| 9| 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 3| 3| 3| 3| 3| | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| _____________________________________________________________________________________________________________________| SPECIAL SENSES SYSTEM - cont | | | | | | __________________________________________________________________________| Eye | | __________________________________________________________________________| Harderian Gland | | _____________________________________________________________________________________________________________________| URINARY SYSTEM | | | | __________________________________________________________________________| Kidney | + + + + + + + + + + + + + + + + + + + +| Infiltration Cellular, Lymphocyte | 2 2 2 2 2 2 2 2 2 2 2 2 2 2| Inflammation, Acute | 3 | Metaplasia, Osseous | | Mineralization | | Renal Tubule, Casts Protein | 2 2 2 2 1 | Renal Tubule, Ectasia | 2 2 2 3 1 | Renal Tubule, Necrosis | 2 1 2 1| Renal Tubule, Regeneration | 2 1 2 2| __________________________________________________________________________| Urinary Bladder | + + + + + + + M + + M + + + + + + + + +| Infiltration Cellular, Lymphocyte | 2 2 2 2 2 2 2 2 2 2 2 2 2 2| _____________________________________________________________________________________________________________________| Page 22 NTP Experiment-Test: 05007-05 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 08:05:11 _____________________________________________________________________________________________________________________ | 4| 4| 7| 7| 7| 4| 7| 7| 7| 7| 6| 7| 7| 7| 7| 4| 4| 4| 4| 4| 4| 6| 7| 7| 7| DAY ON TEST | 7| 7| 3| 3| 3| 4| 1| 3| 3| 3| 9| 1| 3| 3| 3| 5| 5| 5| 5| 5| 4| 4| 3| 3| 3| | 4| 7| 1| 1| 1| 2| 7| 1| 1| 1| 3| 7| 1| 1| 1| 8| 8| 8| 8| 8| 7| 7| 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| 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 | 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5.0% | 4| 4| 4| 4| 4| 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 8| 8| 8| 8| 8| | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| _____________________________________________________________________________________________________________________| ALIMENTARY SYSTEM | | | | __________________________________________________________________________| Esophagus | + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Gallbladder | M + + + + + + + + + + + + + + + + + + +| Infiltration Cellular, Lymphocyte | 2 2 2 2 2 2 2 2 2| __________________________________________________________________________| Intestine Large | + + + + + + A + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Large, Cecum | M + + + + + A + + + + + + + M + + + + +| __________________________________________________________________________| Intestine Large, Colon | + + + + + + A + + + + + + + M + + + + +| __________________________________________________________________________| Intestine Large, Rectum | + + + + + + A + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Small | + + + + + + A + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Small, Duodenum | + + + + + + A + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Small, Ileum | + + + + + + A + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Small, Jejunum | + + + + + + A + + + + + + + + + + + + +| __________________________________________________________________________| Liver | + + + + + + + + + + + + + + + + + + + +| Cytomegaly | | Focal Cellular Change | X | Hematopoietic Cell Proliferation | 2 2 3 1 1 1 2| Infiltration Cellular, Lymphocyte | 1 1 2 2 2 1 2 2 1 | Inflammation, Acute | 2 3 | Necrosis | 2 3 | Serosa, Inflammation, Acute | | __________________________________________________________________________| Mesentery | + + + + + | Inflammation, Acute | 3 3 3 | Inflammation, Chronic Active | | __________________________________________________________________________| Pancreas | + + + + + + + + + + + + + + + + + + + +| Infiltration Cellular, Lymphocyte | 2 2 1 2 2 1 | Inflammation, Acute | 2 | Inflammation, Chronic | 3 | Inflammation, Chronic Active | | Duct, Cyst | X | __________________________________________________________________________| Salivary Glands | + + + + + + + + + + + + + + + + + + + +| Infiltration Cellular, Lymphocyte | 2 2 2 2 2 2 2 2 2 2 2 2 2| Acinus, Atrophy | | __________________________________________________________________________| Stomach | + + + + + + A + + + + + + + + + + + + +| __________________________________________________________________________| Stomach, Forestomach | + + + + + + A + + + + + + + + + + + + +| Erosion | | Hyperplasia, Squamous | 2 2 3 2 2 1 2 3 2| Infiltration Cellular, Lymphocyte | 2 2 2| Inflammation, Acute | | Inflammation, Chronic Active | 2 2 2 | Inflammation, Subacute | 1 | Ulcer | 3 4 | __________________________________________________________________________| Stomach, Glandular | + + + + + + A + + + + + + + + + + + +| Infiltration Cellular, Lymphocyte | 2 2 2 2 2 2 2| Inflammation, Acute | 2| Inflammation, Chronic Active | 2 2 | _____________________________________________________________________________________________________________________| Page 23 NTP Experiment-Test: 05007-05 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 08:05:11 _____________________________________________________________________________________________________________________ | 4| 4| 7| 7| 7| 4| 7| 7| 7| 7| 6| 7| 7| 7| 7| 4| 4| 4| 4| 4| 4| 6| 7| 7| 7| DAY ON TEST | 7| 7| 3| 3| 3| 4| 1| 3| 3| 3| 9| 1| 3| 3| 3| 5| 5| 5| 5| 5| 4| 4| 3| 3| 3| | 4| 7| 1| 1| 1| 2| 7| 1| 1| 1| 3| 7| 1| 1| 1| 8| 8| 8| 8| 8| 7| 7| 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| 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 | 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5.0% | 4| 4| 4| 4| 4| 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 8| 8| 8| 8| 8| | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| _____________________________________________________________________________________________________________________| ALIMENTARY SYSTEM - cont | | | | Mucosa, Inflammation, Acute | | __________________________________________________________________________| Tooth | | _____________________________________________________________________________________________________________________| CARDIOVASCULAR SYSTEM | | | | __________________________________________________________________________| Heart | + + + + + + + + + + + + + + + + + + + +| Embolus Bacterial | | Infiltration Cellular, Lymphocyte | 1 1 | Inflammation, Acute | 2 | Inflammation, Chronic | 2 | Epicardium, Inflammation, Acute | 4 | _____________________________________________________________________________________________________________________| ENDOCRINE SYSTEM | | | | __________________________________________________________________________| Adrenal Gland | + + + + + + + + + + + + + + + + + + + +| Capsule, Inflammation, Acute | | __________________________________________________________________________| Adrenal Gland, Cortex | + + + + + + + + + + + + + + + + + + + +| Congestion | | Degeneration, Fatty | 3 | Inflammation, Acute | | Pigmentation | 2 2 1 2 2 2 2 2 2 2 2| Spindle Cell, Hyperplasia | 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2| __________________________________________________________________________| Adrenal Gland, Medulla | + + + + + + + + + + + + + + + + + + + +| Hyperplasia | 1 | __________________________________________________________________________| Islets, Pancreatic | + + + + + + + + + + + + + + + + + + + +| Inflammation, Chronic | 3 | __________________________________________________________________________| Parathyroid Gland | + M M + M + + M M + M + + + + + M + M M| __________________________________________________________________________| Pituitary Gland | + + + + + + + + + + + + + + + + + + + +| Pars Distalis, Cyst | | Pars Distalis, Hyperplasia | 2 2 2 2 | __________________________________________________________________________| Thyroid Gland | + + + + + + + + + + + + + + + + + + + +| Infiltration Cellular, Lymphocyte | | Inflammation, Chronic | 2 | Follicle, Ectasia | 3 2 | Follicle, Hyperplasia | | _____________________________________________________________________________________________________________________| GENERAL BODY SYSTEM | | | | None | | _____________________________________________________________________________________________________________________| GENITAL SYSTEM | | | | __________________________________________________________________________| Ovary | + + + + + + + + + + + + + + + + + + + +| Abscess | 4 4 4 4 4 4 | Hemorrhage | | Mineralization | 2 | Follicle, Cyst | X | Periovarian Tissue, Cyst | X X | _____________________________________________________________________________________________________________________| Page 24 NTP Experiment-Test: 05007-05 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 08:05:11 _____________________________________________________________________________________________________________________ | 4| 4| 7| 7| 7| 4| 7| 7| 7| 7| 6| 7| 7| 7| 7| 4| 4| 4| 4| 4| 4| 6| 7| 7| 7| DAY ON TEST | 7| 7| 3| 3| 3| 4| 1| 3| 3| 3| 9| 1| 3| 3| 3| 5| 5| 5| 5| 5| 4| 4| 3| 3| 3| | 4| 7| 1| 1| 1| 2| 7| 1| 1| 1| 3| 7| 1| 1| 1| 8| 8| 8| 8| 8| 7| 7| 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| 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 | 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5.0% | 4| 4| 4| 4| 4| 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 8| 8| 8| 8| 8| | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| _____________________________________________________________________________________________________________________| GENITAL SYSTEM - cont | | | | __________________________________________________________________________| Uterus | + + + + + + + + + + + + + + + + + + + +| Abscess | 4 | Angiectasis | | Hydrometra | | Endometrium, Abscess | | Endometrium, Hyperplasia, Cystic | 2 2 2 3 2 3 3 3 3 4 2 3 4 3 3 2 3 3| Endometrium, Inflammation, Acute | 2 3 2 3 2 2 2 3| Endometrium, Metaplasia, Squamous | 2 | __________________________________________________________________________| Vagina | + + | _____________________________________________________________________________________________________________________| HEMATOPOIETIC SYSTEM | | | | __________________________________________________________________________| Bone Marrow | + + + + + + + + + + + + + + + + + + + +| Myelofibrosis | 2 2 2 2 | Myeloid Cell, Hyperplasia | 2 3 2 2 2 2 2 2 2 2 2 2 2 2 3| __________________________________________________________________________| Lymph Node | + + + + + + + + + + + + + + + + + + + +| Mediastinal, Hyperplasia, Lymphoid | 2 | Mediastinal, Inflammation, Acute | 4 | Renal, Hyperplasia, Lymphoid | 3 | Renal, Inflammation, Acute | | __________________________________________________________________________| Lymph Node, Mandibular | + + + + + + + + + + + + + + + + + + + +| Congestion | 2 | Hyperplasia, Lymphoid | 2 2 2 2 2 2 2 2 3 2 2 2 2 2| Inflammation, Acute | | Pigmentation | 2 2 2 2 2 2 3 2 2 | __________________________________________________________________________| Lymph Node, Mesenteric | + + + + + + + + + + + + + + + + A + + +| Congestion | | Hyperplasia, Lymphoid | 2 2 2 2 2 2 3 2 2 1 3| Inflammation, Acute | | Pigmentation | 2 | __________________________________________________________________________| Spleen | + + + + + + + + + + + + + + + + + + + +| Hematopoietic Cell Proliferation | 4 3 2 2 1 2 3 2 3 2 2 2 2 2 2 3 2 2 2 4| Hyperplasia, Lymphoid | 2 2 3 | Inflammation, Acute | | Pigmentation | 1 2 1 2 1 2 2 2 1 2 2 1| __________________________________________________________________________| Thymus | + + + + + + + + + + + + + + + + + + + +| Cyst | X X X X| Hyperplasia, Lymphoid | 2 2 2 2 2 2| Inflammation, Acute | | _____________________________________________________________________________________________________________________| INTEGUMENTARY SYSTEM | | | | __________________________________________________________________________| Mammary Gland | + + + + + + + + + + + + + + + + + + + +| Acinus, Ectasia | 1 2 2 2 | Duct, Ectasia | 2 2 | __________________________________________________________________________| Skin | + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| Page 25 NTP Experiment-Test: 05007-05 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 08:05:11 _____________________________________________________________________________________________________________________ | 4| 4| 7| 7| 7| 4| 7| 7| 7| 7| 6| 7| 7| 7| 7| 4| 4| 4| 4| 4| 4| 6| 7| 7| 7| DAY ON TEST | 7| 7| 3| 3| 3| 4| 1| 3| 3| 3| 9| 1| 3| 3| 3| 5| 5| 5| 5| 5| 4| 4| 3| 3| 3| | 4| 7| 1| 1| 1| 2| 7| 1| 1| 1| 3| 7| 1| 1| 1| 8| 8| 8| 8| 8| 7| 7| 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| 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 | 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5.0% | 4| 4| 4| 4| 4| 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 8| 8| 8| 8| 8| | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| _____________________________________________________________________________________________________________________| INTEGUMENTARY SYSTEM - cont | | | | Inflammation, Chronic | 1 1 2 2 2 1| Inflammation, Chronic Active | | _____________________________________________________________________________________________________________________| MUSCULOSKELETAL SYSTEM | | | | __________________________________________________________________________| Bone | + + + + + + + + + + + + + + + + + + + +| Cranium, Inflammation, Chronic | 3 | __________________________________________________________________________| Skeletal Muscle | + | _____________________________________________________________________________________________________________________| NERVOUS SYSTEM | | | | __________________________________________________________________________| Brain | + + + + + + + + + + + + + + + + + + + +| Compression | | Gliosis | | Hemorrhage | | Hydrocephalus | | Infiltration Cellular, Lymphocyte | | Mineralization | 2 2 2 2 1 2 2 2 1 2 2| Meninges, Hemorrhage | 2 | Meninges, Inflammation, Chronic | | __________________________________________________________________________| Spinal Cord | | _____________________________________________________________________________________________________________________| RESPIRATORY SYSTEM | | | | __________________________________________________________________________| Lung | + + + + + + + + + + + + + + + + + + + +| Congestion | 2 3 | Hemorrhage | 2 1 2 | Infiltration Cellular, Lymphocyte | 2 2 2 2 2 1 2 2 2 2 2 2 2 2 2 2 2| Alveolar Epithelium, Hyperplasia | 2 | Alveolus, Infiltration Cellular, | | Histiocyte | 4 1 | Bronchiole, Inflammation, Acute | | Interstitium, Inflammation, Acute | 2 | Interstitium, Inflammation, Chronic | 3| Interstitium, Inflammation, Chronic | | Active | | Mediastinum, Inflammation, Acute | 2 | Peribronchial, Inflammation, Acute | | Pleura, Inflammation, Acute | 1 | __________________________________________________________________________| Nose | + + + + + + + + + + + + + + + + + + + +| Lumen, Hemorrhage | 2 2 2 1 2 2| Nasolacrimal Duct, Hemorrhage | 2 2 2 1 1 | Nasolacrimal Duct, Inflammation, | | Acute | 1 | Olfactory Epithelium, Degeneration | 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2| __________________________________________________________________________| Trachea | + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| SPECIAL SENSES SYSTEM | | _____________________________________________________________________________________________________________________| Page 26 NTP Experiment-Test: 05007-05 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 08:05:11 _____________________________________________________________________________________________________________________ | 4| 4| 7| 7| 7| 4| 7| 7| 7| 7| 6| 7| 7| 7| 7| 4| 4| 4| 4| 4| 4| 6| 7| 7| 7| DAY ON TEST | 7| 7| 3| 3| 3| 4| 1| 3| 3| 3| 9| 1| 3| 3| 3| 5| 5| 5| 5| 5| 4| 4| 3| 3| 3| | 4| 7| 1| 1| 1| 2| 7| 1| 1| 1| 3| 7| 1| 1| 1| 8| 8| 8| 8| 8| 7| 7| 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| 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 | 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5.0% | 4| 4| 4| 4| 4| 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 8| 8| 8| 8| 8| | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| _____________________________________________________________________________________________________________________| SPECIAL SENSES SYSTEM - cont | | | | | | __________________________________________________________________________| Eye | | __________________________________________________________________________| Harderian Gland | | _____________________________________________________________________________________________________________________| URINARY SYSTEM | | | | __________________________________________________________________________| Kidney | + + + + + + + + + + + + + + + + + + + +| Infiltration Cellular, Lymphocyte | 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2| Inflammation, Acute | 4 | Metaplasia, Osseous | | Mineralization | 1 | Renal Tubule, Casts Protein | 2 1 1 2 | Renal Tubule, Ectasia | 2 1 1 2 1 2 | Renal Tubule, Necrosis | 2 1 1 2 1 | Renal Tubule, Regeneration | 2 1 1 2 1 | __________________________________________________________________________| Urinary Bladder | + + + + + + + + + + + + + + + + + + + +| Infiltration Cellular, Lymphocyte | 2 2 2 2 2 2 2 2 2 2 2 2| _____________________________________________________________________________________________________________________| Page 27 NTP Experiment-Test: 05007-05 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 08:05:11 __________________________________________________________________________________________________________________________________ | 4| 5| 6| 7| 7| 6| 7| 7| 7| 7| | | DAY ON TEST | 0| 1| 2| 3| 3| 8| 3| 3| 3| 3| | | | 9| 4| 9| 4| 4| 7| 4| 4| 4| 4| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | B6C3F1 MICE FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| | A | 5.0% | 9| 9| 9| 9| 9| 0| 0| 0| 0| 0| | L | | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| | | __________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM | | | | | | __________________________________________________________________________|____________| Esophagus | + + + + + + + + + + | 49 | __________________________________________________________________________|____________| Gallbladder | + + + + + + + + + + | 47 | Infiltration Cellular, Lymphocyte | 2 2 2 | 17 1.9| __________________________________________________________________________|____________| Intestine Large | + A + + + + + + + + | 47 | __________________________________________________________________________|____________| Intestine Large, Cecum | + A + + + + + + + + | 44 | __________________________________________________________________________|____________| Intestine Large, Colon | + A + + + + + + + + | 46 | __________________________________________________________________________|____________| Intestine Large, Rectum | + A + + + + + + + + | 47 | __________________________________________________________________________|____________| Intestine Small | + A + + + + + + + + | 47 | __________________________________________________________________________|____________| Intestine Small, Duodenum | + A + + + + + + + + | 47 | __________________________________________________________________________|____________| Intestine Small, Ileum | + A + + + + + + + + | 45 | __________________________________________________________________________|____________| Intestine Small, Jejunum | + A + + + + + + + + | 47 | __________________________________________________________________________|____________| Liver | + + + + + + + + + + | 49 | Cytomegaly | | 1 3.0| Focal Cellular Change | | 1 | Hematopoietic Cell Proliferation | 2 2 1 2 | 21 1.9| Infiltration Cellular, Lymphocyte | 2 2 2 2 | 23 1.7| Inflammation, Acute | 2 1 | 5 2.0| Necrosis | | 2 2.5| Serosa, Inflammation, Acute | | 1 3.0| __________________________________________________________________________|____________| Mesentery | + + | 13 | Inflammation, Acute | 3 | 8 3.3| Inflammation, Chronic Active | | 1 3.0| __________________________________________________________________________|____________| Pancreas | + A + + + + + + + + | 48 | Infiltration Cellular, Lymphocyte | 2 3 2 2 2 | 15 1.9| Inflammation, Acute | | 2 2.0| Inflammation, Chronic | | 1 3.0| Inflammation, Chronic Active | | 1 4.0| Duct, Cyst | | 2 | __________________________________________________________________________|____________| Salivary Glands | M M + + + + + + + + | 46 | Infiltration Cellular, Lymphocyte | 2 2 2 2 | 31 2.0| Acinus, Atrophy | 3 | 1 3.0| __________________________________________________________________________|____________| Stomach | + + + + + + + + + + | 49 | __________________________________________________________________________|____________| Stomach, Forestomach | + + + + + + + + + + | 49 | Erosion | 2 | 1 2.0| Hyperplasia, Squamous | 1 3 2 4 2 2 | 26 2.2| Infiltration Cellular, Lymphocyte | 2 | 6 2.0| Inflammation, Acute | | 3 2.0| Inflammation, Chronic Active | 2 4 3 1 1 | 13 2.2| Inflammation, Subacute | | 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 28 NTP Experiment-Test: 05007-05 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 08:05:11 __________________________________________________________________________________________________________________________________ | 4| 5| 6| 7| 7| 6| 7| 7| 7| 7| | | DAY ON TEST | 0| 1| 2| 3| 3| 8| 3| 3| 3| 3| | | | 9| 4| 9| 4| 4| 7| 4| 4| 4| 4| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | B6C3F1 MICE FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| | A | 5.0% | 9| 9| 9| 9| 9| 0| 0| 0| 0| 0| | L | | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| | | __________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - cont | | | | | | Ulcer | 1 | 7 3.0| __________________________________________________________________________|____________| Stomach, Glandular | + + + + + + + + + + | 48 | Infiltration Cellular, Lymphocyte | 2 2 2 | 13 2.0| Inflammation, Acute | | 1 2.0| Inflammation, Chronic Active | | 3 2.0| Mucosa, Inflammation, Acute | | 1 2.0| __________________________________________________________________________|____________| Tooth | + | 1 | _____________________________________________________________________________________________________________________| | CARDIOVASCULAR SYSTEM | | | | | | __________________________________________________________________________|____________| Heart | + + + + + + + + + + | 50 | Embolus Bacterial | | 1 4.0| Infiltration Cellular, Lymphocyte | 2 1 | 8 1.3| Inflammation, Acute | | 3 2.3| Inflammation, Chronic | | 1 2.0| Epicardium, Inflammation, Acute | | 2 3.0| _____________________________________________________________________________________________________________________| | ENDOCRINE SYSTEM | | | | | | __________________________________________________________________________|____________| Adrenal Gland | + + + + + + + + + + | 50 | Capsule, Inflammation, Acute | | 1 3.0| __________________________________________________________________________|____________| Adrenal Gland, Cortex | + + + + + + + + + + | 50 | Congestion | | 2 2.5| Degeneration, Fatty | 2 2 3 | 4 2.5| Inflammation, Acute | | 1 2.0| Pigmentation | 2 2 1 2 2 2 2 2 | 32 1.8| Spindle Cell, Hyperplasia | 2 2 2 2 2 2 2 2 2 | 49 2.0| __________________________________________________________________________|____________| Adrenal Gland, Medulla | + + + + + + + + + + | 50 | Hyperplasia | | 2 1.5| __________________________________________________________________________|____________| Islets, Pancreatic | + A + + + + + + + + | 48 | Inflammation, Chronic | | 1 3.0| __________________________________________________________________________|____________| Parathyroid Gland | M M + + M + M M + + | 27 | __________________________________________________________________________|____________| Pituitary Gland | + + + + + M + + + + | 48 | Pars Distalis, Cyst | | 1 | Pars Distalis, Hyperplasia | | 8 2.1| __________________________________________________________________________|____________| Thyroid Gland | M M + + + + + M + + | 46 | Infiltration Cellular, Lymphocyte | 1 2 | 5 1.6| Inflammation, Chronic | | 1 2.0| Follicle, Ectasia | 2 | 5 2.2| Follicle, Hyperplasia | 1 3 | 2 2.0| _____________________________________________________________________________________________________________________| | GENERAL BODY SYSTEM | | | | | | None | | | __________________________________________________________________________________________________________________________________ * : 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: 05007-05 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 08:05:11 __________________________________________________________________________________________________________________________________ | 4| 5| 6| 7| 7| 6| 7| 7| 7| 7| | | DAY ON TEST | 0| 1| 2| 3| 3| 8| 3| 3| 3| 3| | | | 9| 4| 9| 4| 4| 7| 4| 4| 4| 4| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | B6C3F1 MICE FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| | A | 5.0% | 9| 9| 9| 9| 9| 0| 0| 0| 0| 0| | L | | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| | | __________________________________________________________________________________________________________________________________ GENITAL SYSTEM | | | | | | __________________________________________________________________________|____________| Ovary | + + + + + + + + + + | 50 | Abscess | 4 4 4 4 | 16 4.0| Hemorrhage | | 1 4.0| Mineralization | | 1 2.0| Follicle, Cyst | | 3 | Periovarian Tissue, Cyst | X X X X | 8 | __________________________________________________________________________|____________| Uterus | + + + + + + + + + + | 50 | Abscess | | 1 4.0| Angiectasis | | 1 2.0| Hydrometra | 3 | 1 3.0| Endometrium, Abscess | | 1 4.0| Endometrium, Hyperplasia, Cystic | 2 3 2 4 3 2 3 3 3 | 45 2.8| Endometrium, Inflammation, Acute | 3 2 2 1 | 17 2.4| Endometrium, Metaplasia, Squamous | 2 | 2 2.0| __________________________________________________________________________|____________| Vagina | + | 5 | _____________________________________________________________________________________________________________________| | HEMATOPOIETIC SYSTEM | | | | | | __________________________________________________________________________|____________| Bone Marrow | + + + + + + + + + + | 50 | Myelofibrosis | 2 1 1 2 1 | 13 1.8| Myeloid Cell, Hyperplasia | 2 3 2 3 2 2 2 2 | 38 2.2| __________________________________________________________________________|____________| Lymph Node | + + + + + + + + + + | 49 | Mediastinal, Hyperplasia, Lymphoid | 2 2 | 6 2.2| Mediastinal, Inflammation, Acute | | 2 4.0| Renal, Hyperplasia, Lymphoid | 2 4 | 6 3.0| Renal, Inflammation, Acute | | 1 3.0| __________________________________________________________________________|____________| Lymph Node, Mandibular | M M + + + + + + + + | 46 | Congestion | | 1 2.0| Hyperplasia, Lymphoid | 2 2 2 2 3 2 2 2 | 39 2.1| Inflammation, Acute | 3 | 1 3.0| Pigmentation | 2 2 2 2 | 22 2.0| __________________________________________________________________________|____________| Lymph Node, Mesenteric | + + + + + + + + + + | 48 | Congestion | | 1 2.0| Hyperplasia, Lymphoid | 2 2 2 3 2 2 | 32 2.1| Inflammation, Acute | 3 | 3 2.7| Pigmentation | | 1 2.0| __________________________________________________________________________|____________| Spleen | + + + + + + + + + + | 49 | Hematopoietic Cell Proliferation | 3 3 3 2 4 3 3 2 2 | 44 2.7| Hyperplasia, Lymphoid | 2 | 11 2.1| Inflammation, Acute | | 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 30 NTP Experiment-Test: 05007-05 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 08:05:11 __________________________________________________________________________________________________________________________________ | 4| 5| 6| 7| 7| 6| 7| 7| 7| 7| | | DAY ON TEST | 0| 1| 2| 3| 3| 8| 3| 3| 3| 3| | | | 9| 4| 9| 4| 4| 7| 4| 4| 4| 4| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | B6C3F1 MICE FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| | A | 5.0% | 9| 9| 9| 9| 9| 0| 0| 0| 0| 0| | L | | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| | | __________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - cont | | | | | | Pigmentation | 2 2 1 1 2 1 | 26 1.7| __________________________________________________________________________|____________| Thymus | + + + + + + + + + + | 48 | Cyst | | 7 | Hyperplasia, Lymphoid | 2 3 2 | 12 2.1| Inflammation, Acute | | 1 3.0| _____________________________________________________________________________________________________________________| | INTEGUMENTARY SYSTEM | | | | | | __________________________________________________________________________|____________| Mammary Gland | + + + + + + + + + + | 48 | Acinus, Ectasia | 2 2 2 2 | 13 1.8| Duct, Ectasia | | 4 2.0| __________________________________________________________________________|____________| Skin | + + + + + + + + + + | 50 | Inflammation, Chronic | 2 2 2 1 | 15 1.7| Inflammation, Chronic Active | 2 | 1 2.0| _____________________________________________________________________________________________________________________| | MUSCULOSKELETAL SYSTEM | | | | | | __________________________________________________________________________|____________| Bone | + + + + + + + + + + | 50 | Cranium, Inflammation, Chronic | | 2 3.0| __________________________________________________________________________|____________| Skeletal Muscle | | 2 | _____________________________________________________________________________________________________________________| | NERVOUS SYSTEM | | | | | | __________________________________________________________________________|____________| Brain | + + + + + + + + + + | 50 | Compression | | 1 | Gliosis | | 1 2.0| Hemorrhage | 3 | 1 3.0| Hydrocephalus | | 1 3.0| Infiltration Cellular, Lymphocyte | | 1 2.0| Mineralization | 2 2 2 2 2 | 27 1.9| Meninges, Hemorrhage | | 1 2.0| Meninges, Inflammation, Chronic | 2 | 1 2.0| __________________________________________________________________________|____________| Spinal Cord | + | 1 | _____________________________________________________________________________________________________________________| | RESPIRATORY SYSTEM | | | | | | __________________________________________________________________________|____________| Lung | + + + + + + + + + + | 50 | Congestion | 2 | 4 2.5| Hemorrhage | | 3 1.7| Infiltration Cellular, Lymphocyte | 2 2 2 2 2 2 2 2 | 42 2.0| Alveolar Epithelium, Hyperplasia | | 1 2.0| Alveolus, Infiltration Cellular, | | | Histiocyte | | 2 2.5| __________________________________________________________________________________________________________________________________ * : 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: 05007-05 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 08:05:11 __________________________________________________________________________________________________________________________________ | 4| 5| 6| 7| 7| 6| 7| 7| 7| 7| | | DAY ON TEST | 0| 1| 2| 3| 3| 8| 3| 3| 3| 3| | | | 9| 4| 9| 4| 4| 7| 4| 4| 4| 4| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | B6C3F1 MICE FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| | A | 5.0% | 9| 9| 9| 9| 9| 0| 0| 0| 0| 0| | L | | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| | | __________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM - cont | | | | | | Bronchiole, Inflammation, Acute | | 1 2.0| Interstitium, Inflammation, Acute | 2 | 5 2.2| Interstitium, Inflammation, Chronic | | 1 3.0| Interstitium, Inflammation, Chronic | | | Active | 2 | 1 2.0| Mediastinum, Inflammation, Acute | 2 | 3 2.7| Peribronchial, Inflammation, Acute | | 1 4.0| Pleura, Inflammation, Acute | | 1 1.0| __________________________________________________________________________|____________| Nose | + + + + + + + + + + | 50 | Lumen, Hemorrhage | 1 2 2 1 | 13 1.8| Nasolacrimal Duct, Hemorrhage | 1 2 | 11 1.6| Nasolacrimal Duct, Inflammation, | | | Acute | | 1 1.0| Olfactory Epithelium, Degeneration | 2 2 2 2 2 2 2 2 2 | 49 2.0| __________________________________________________________________________|____________| Trachea | M M + + + + + + + + | 47 | _____________________________________________________________________________________________________________________| | SPECIAL SENSES SYSTEM | | | | | | __________________________________________________________________________|____________| Eye | + | 1 | __________________________________________________________________________|____________| Harderian Gland | + | 1 | _____________________________________________________________________________________________________________________| | URINARY SYSTEM | | | | | | __________________________________________________________________________|____________| Kidney | + + + + + + + + + + | 50 | Infiltration Cellular, Lymphocyte | 2 2 2 2 2 2 2 2 2 | 40 2.0| Inflammation, Acute | | 2 3.5| Metaplasia, Osseous | 2 | 1 2.0| Mineralization | | 1 1.0| Renal Tubule, Casts Protein | 2 1 | 11 1.6| Renal Tubule, Ectasia | 1 2 2 1 | 15 1.7| Renal Tubule, Necrosis | 1 2 | 11 1.5| Renal Tubule, Regeneration | 2 1 | 11 1.5| __________________________________________________________________________|____________| Urinary Bladder | + + + + + + + + + + | 48 | Infiltration Cellular, Lymphocyte | 2 2 2 2 2 2 2 2 2 | 35 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 32 NTP Experiment-Test: 05007-05 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 08:05:11 _____________________________________________________________________________________________________________________ | 6| 6| 7| 7| 7| 5| 6| 7| 7| 7| 4| 4| 4| 4| 4| 4| 5| 7| 7| 7| 4| 5| 7| 7| 7| DAY ON TEST | 1| 7| 3| 3| 3| 8| 5| 0| 3| 3| 5| 5| 5| 5| 5| 9| 2| 3| 3| 3| 5| 8| 3| 3| 3| | 0| 2| 4| 4| 4| 5| 1| 3| 4| 4| 8| 8| 8| 8| 8| 9| 3| 4| 4| 4| 8| 8| 4| 4| 4| _____________________________________________________________________________________________________________________| | 0| 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 | 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 2.5% | 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 5| 5| 5| 5| 5| | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| _____________________________________________________________________________________________________________________| ALIMENTARY SYSTEM | | | | __________________________________________________________________________| Esophagus | + + + + + + + + + | __________________________________________________________________________| Gallbladder | + + + + + + + + M | Infiltration Cellular, Lymphocyte | 2 2 | __________________________________________________________________________| Intestine Large | + + + + + + + A + | __________________________________________________________________________| Intestine Large, Cecum | + + + + + + + A + | __________________________________________________________________________| Intestine Large, Colon | + + + + + + + A + | __________________________________________________________________________| Intestine Large, Rectum | + + + + + + + A + | __________________________________________________________________________| Intestine Small | + + + + + + + A + | __________________________________________________________________________| Intestine Small, Duodenum | + + + + + + + A + | __________________________________________________________________________| Intestine Small, Ileum | + + + + + + + A + | __________________________________________________________________________| Intestine Small, Jejunum | + + + + + + + A + | __________________________________________________________________________| Liver | + + + + + + + + + + + | Hematopoietic Cell Proliferation | 1 2 | Infiltration Cellular, Lymphocyte | 2 | Inflammation, Acute | | Necrosis | 3 | __________________________________________________________________________| Mesentery | + | Cyst | | Inflammation, Acute | 3 | __________________________________________________________________________| Pancreas | + + + + + + + A + + | Infiltration Cellular, Lymphocyte | 1 | Inflammation, Chronic Active | 3 | Acinus, Atrophy | | __________________________________________________________________________| Salivary Glands | + + + + + M + M + | Infiltration Cellular, Lymphocyte | 2 2 2 2 2 | __________________________________________________________________________| Stomach | + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Stomach, Forestomach | + + + + + + + + + + + + + + + + + + + +| Cyst Epithelial Inclusion | | Erosion | | Hyperplasia, Squamous | 2 2 2 | Inflammation, Acute | 2 2 | __________________________________________________________________________| Stomach, Glandular | + + + + + + + + + + + + + + + A + + + +| Infiltration Cellular, Lymphocyte | 2| Mineralization | 1 | _____________________________________________________________________________________________________________________| CARDIOVASCULAR SYSTEM | | | | __________________________________________________________________________| Heart | + + + + + + + + + | Infiltration Cellular, Lymphocyte | 2 | _____________________________________________________________________________________________________________________| ENDOCRINE SYSTEM | | | | __________________________________________________________________________| Adrenal Gland | + + + + + + + + + | __________________________________________________________________________| Adrenal Gland, Cortex | + + + + + + + + + | Pigmentation | 1 1 2 | Spindle Cell, Hyperplasia | 2 2 1 2 2 2 2 2 2 | _____________________________________________________________________________________________________________________| Page 33 NTP Experiment-Test: 05007-05 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 08:05:11 _____________________________________________________________________________________________________________________ | 6| 6| 7| 7| 7| 5| 6| 7| 7| 7| 4| 4| 4| 4| 4| 4| 5| 7| 7| 7| 4| 5| 7| 7| 7| DAY ON TEST | 1| 7| 3| 3| 3| 8| 5| 0| 3| 3| 5| 5| 5| 5| 5| 9| 2| 3| 3| 3| 5| 8| 3| 3| 3| | 0| 2| 4| 4| 4| 5| 1| 3| 4| 4| 8| 8| 8| 8| 8| 9| 3| 4| 4| 4| 8| 8| 4| 4| 4| _____________________________________________________________________________________________________________________| | 0| 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 | 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 2.5% | 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 5| 5| 5| 5| 5| | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| _____________________________________________________________________________________________________________________| ENDOCRINE SYSTEM - cont | | | | __________________________________________________________________________| Adrenal Gland, Medulla | + + + + + + + + + | __________________________________________________________________________| Islets, Pancreatic | + + + + + + + A + | __________________________________________________________________________| Parathyroid Gland | + M M M + M + M M | __________________________________________________________________________| Pituitary Gland | + + + + + + M M + +| Pars Distalis, Angiectasis | 2 | Pars Distalis, Hyperplasia | 2 | __________________________________________________________________________| Thyroid Gland | + + + + + M + M + | Follicle, Ectasia | | Follicle, Hyperplasia | | _____________________________________________________________________________________________________________________| GENERAL BODY SYSTEM | | | | None | | _____________________________________________________________________________________________________________________| GENITAL SYSTEM | | | | __________________________________________________________________________| Ovary | + + + + + + + + + + + + + + | Abscess | 4 4 4 4 4 | Follicle, Cyst | 2 | Periovarian Tissue, Cyst | 2 2 2 2 2 2 | __________________________________________________________________________| Uterus | + + + + + + + + + + + + + + + + | Abscess | 3 4 | Hydrometra | | Endometrium, Angiectasis | 2 | Endometrium, Hyperplasia, Cystic | 2 2 2 3 2 3 2 2 3 2 2 2 4 3 | Endometrium, Inflammation, Acute | 2 2 | Endometrium, Metaplasia, Squamous | | __________________________________________________________________________| Vagina | + + + | _____________________________________________________________________________________________________________________| HEMATOPOIETIC SYSTEM | | | | __________________________________________________________________________| Bone Marrow | + + + + + + + + + | Myelofibrosis | 2 | Myeloid Cell, Hyperplasia | 2 2 2 2 3 | __________________________________________________________________________| Lymph Node | + + + + + + + A + | Iliac, Hyperplasia, Lymphoid | | Mediastinal, Hyperplasia, Lymphoid | 2 2 2 | Mediastinal, Inflammation, Acute | 4 | Pancreatic, Hyperplasia, Lymphoid | | Renal, Hyperplasia, Lymphoid | 3 3 | Renal, Inflammation, Acute | 4 3 | __________________________________________________________________________| Lymph Node, Mandibular | + + + + + M + M + | Hyperplasia, Lymphoid | 2 2 2 2 | Pigmentation | | __________________________________________________________________________| Lymph Node, Mesenteric | + + + + + + + A + | Congestion | 3 | Hyperplasia, Lymphoid | 2 2 3 2 | _____________________________________________________________________________________________________________________| Page 34 NTP Experiment-Test: 05007-05 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 08:05:11 _____________________________________________________________________________________________________________________ | 6| 6| 7| 7| 7| 5| 6| 7| 7| 7| 4| 4| 4| 4| 4| 4| 5| 7| 7| 7| 4| 5| 7| 7| 7| DAY ON TEST | 1| 7| 3| 3| 3| 8| 5| 0| 3| 3| 5| 5| 5| 5| 5| 9| 2| 3| 3| 3| 5| 8| 3| 3| 3| | 0| 2| 4| 4| 4| 5| 1| 3| 4| 4| 8| 8| 8| 8| 8| 9| 3| 4| 4| 4| 8| 8| 4| 4| 4| _____________________________________________________________________________________________________________________| | 0| 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 | 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 2.5% | 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 5| 5| 5| 5| 5| | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| _____________________________________________________________________________________________________________________| HEMATOPOIETIC SYSTEM - cont | | | | __________________________________________________________________________| Spleen | + + + + + + + + A + + | Hematopoietic Cell Proliferation | 3 4 2 3 2 3 2 3 | Hyperplasia, Lymphoid | | Inflammation, Acute | | Pigmentation | | Capsule, Inflammation, Chronic | 3 | __________________________________________________________________________| Thymus | + + + + + M + + + | Hyperplasia, Lymphoid | 2 2 2 | _____________________________________________________________________________________________________________________| INTEGUMENTARY SYSTEM | | | | __________________________________________________________________________| Mammary Gland | + + + + + + + + M + | Acinus, Ectasia | | Duct, Ectasia | 2 2 1 | __________________________________________________________________________| Skin | + + + + + + + + + + + + + + + +| Inflammation, Chronic | 2 2 2 2 | Head, Ulcer | | _____________________________________________________________________________________________________________________| MUSCULOSKELETAL SYSTEM | | | | __________________________________________________________________________| Bone | + + + + + + + + + | _____________________________________________________________________________________________________________________| NERVOUS SYSTEM | | | | __________________________________________________________________________| Brain | + + + + + + + + + | Hydrocephalus | | Mineralization | 1 2 2 1 1 1 | _____________________________________________________________________________________________________________________| RESPIRATORY SYSTEM | | | | __________________________________________________________________________| Lung | + + + + + + + + + | Congestion | 2 | Hemorrhage | 2 | Infiltration Cellular, Lymphocyte | 2 2 2 2 2 2 2 1 | Alveolus, Infiltration Cellular, | | Histiocyte | 2 | Interstitium, Inflammation, Acute | 3 2 | Mediastinum, Inflammation, Acute | 3 | Peribronchial, Inflammation, Acute | | Pleura, Inflammation, Acute | 3 | __________________________________________________________________________| Nose | + + + + + + + + + | Lumen, Hemorrhage | 2 | Nasolacrimal Duct, Hemorrhage | 2 | Olfactory Epithelium, Degeneration | 2 2 2 2 2 2 1 2 2 | __________________________________________________________________________| Trachea | + + + + + + + + + | _____________________________________________________________________________________________________________________| SPECIAL SENSES SYSTEM | | | | __________________________________________________________________________| Eye | + | _____________________________________________________________________________________________________________________| Page 35 NTP Experiment-Test: 05007-05 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 08:05:11 _____________________________________________________________________________________________________________________ | 6| 6| 7| 7| 7| 5| 6| 7| 7| 7| 4| 4| 4| 4| 4| 4| 5| 7| 7| 7| 4| 5| 7| 7| 7| DAY ON TEST | 1| 7| 3| 3| 3| 8| 5| 0| 3| 3| 5| 5| 5| 5| 5| 9| 2| 3| 3| 3| 5| 8| 3| 3| 3| | 0| 2| 4| 4| 4| 5| 1| 3| 4| 4| 8| 8| 8| 8| 8| 9| 3| 4| 4| 4| 8| 8| 4| 4| 4| _____________________________________________________________________________________________________________________| | 0| 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 | 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 2.5% | 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 5| 5| 5| 5| 5| | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| _____________________________________________________________________________________________________________________| SPECIAL SENSES SYSTEM - cont | | | | _____________________________________________________________________________________________________________________| URINARY SYSTEM | | | | __________________________________________________________________________| Kidney | + + + + + + + + + | Amyloid Deposition | | Infiltration Cellular, Lymphocyte | 1 2 2 2 2 2 | Inflammation, Acute | 4 | Inflammation, Chronic Active | | Renal Tubule, Casts Protein | 2 | Renal Tubule, Ectasia | 2 1 | Renal Tubule, Mineralization | 2 | __________________________________________________________________________| Urinary Bladder | + + + + + + + + M | Infiltration Cellular, Lymphocyte | 2 2 2 2 | _____________________________________________________________________________________________________________________| Page 36 NTP Experiment-Test: 05007-05 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 08:05:11 _____________________________________________________________________________________________________________________ | 1| 4| 7| 7| 7| 2| 7| 7| 7| 7| 6| 6| 7| 7| 7| 5| 6| 7| 7| 7| 1| 7| 7| 7| 7| DAY ON TEST | 1| 9| 3| 3| 3| 4| 0| 3| 3| 3| 3| 3| 3| 3| 3| 8| 2| 3| 3| 3| 9| 0| 3| 3| 3| | 4| 8| 4| 4| 4| 7| 7| 5| 5| 5| 7| 8| 5| 5| 5| 8| 8| 5| 5| 5| 2| 6| 5| 5| 5| _____________________________________________________________________________________________________________________| | 0| 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 | 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 2.5% | 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 0| 0| 0| 0| 0| | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| _____________________________________________________________________________________________________________________| ALIMENTARY SYSTEM | | | | __________________________________________________________________________| Esophagus | + + + + + + + + + + | __________________________________________________________________________| Gallbladder | M + M + + + M + + + | Infiltration Cellular, Lymphocyte | | __________________________________________________________________________| Intestine Large | M + + + + + + + A + | __________________________________________________________________________| Intestine Large, Cecum | M + + + + + + + A + | __________________________________________________________________________| Intestine Large, Colon | M + + + + + + + A + | __________________________________________________________________________| Intestine Large, Rectum | M + + + M + + + A + | __________________________________________________________________________| Intestine Small | M + + + + + + + + A + | __________________________________________________________________________| Intestine Small, Duodenum | M + + + + + + + A + | __________________________________________________________________________| Intestine Small, Ileum | M + + + + + + + A + | __________________________________________________________________________| Intestine Small, Jejunum | M + + + + + + + + A + | __________________________________________________________________________| Liver | + + + + + + + + + + + | Hematopoietic Cell Proliferation | 2 2 | Infiltration Cellular, Lymphocyte | 1 2 1 | Inflammation, Acute | | Necrosis | 3 | __________________________________________________________________________| Mesentery | + + | Cyst | | Inflammation, Acute | 3 | __________________________________________________________________________| Pancreas | + + + + + + + + + A + | Infiltration Cellular, Lymphocyte | | Inflammation, Chronic Active | | Acinus, Atrophy | 1 | __________________________________________________________________________| Salivary Glands | M + + + + + + + + + | Infiltration Cellular, Lymphocyte | 2 2 2 2 2 | __________________________________________________________________________| Stomach | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Stomach, Forestomach | + + + + + + + + + + + + + + + + + + + + + + + + +| Cyst Epithelial Inclusion | X | Erosion | 2 | Hyperplasia, Squamous | 2 2 1 1 2 | Inflammation, Acute | 2 2 | __________________________________________________________________________| Stomach, Glandular | + + + + + + + + + + + + + + + + + + + + + + + + +| Infiltration Cellular, Lymphocyte | 2 2 2 2 2| Mineralization | 2 | _____________________________________________________________________________________________________________________| CARDIOVASCULAR SYSTEM | | | | __________________________________________________________________________| Heart | + + + + + + + + + + | Infiltration Cellular, Lymphocyte | 2 | _____________________________________________________________________________________________________________________| ENDOCRINE SYSTEM | | | | __________________________________________________________________________| Adrenal Gland | + + + + + + + + + + | __________________________________________________________________________| Adrenal Gland, Cortex | + + + + + + + + + + | Pigmentation | 1 2 | Spindle Cell, Hyperplasia | 2 2 2 2 2 2 2 2 2 2 | _____________________________________________________________________________________________________________________| Page 37 NTP Experiment-Test: 05007-05 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 08:05:11 _____________________________________________________________________________________________________________________ | 1| 4| 7| 7| 7| 2| 7| 7| 7| 7| 6| 6| 7| 7| 7| 5| 6| 7| 7| 7| 1| 7| 7| 7| 7| DAY ON TEST | 1| 9| 3| 3| 3| 4| 0| 3| 3| 3| 3| 3| 3| 3| 3| 8| 2| 3| 3| 3| 9| 0| 3| 3| 3| | 4| 8| 4| 4| 4| 7| 7| 5| 5| 5| 7| 8| 5| 5| 5| 8| 8| 5| 5| 5| 2| 6| 5| 5| 5| _____________________________________________________________________________________________________________________| | 0| 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 | 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 2.5% | 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 0| 0| 0| 0| 0| | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| _____________________________________________________________________________________________________________________| ENDOCRINE SYSTEM - cont | | | | __________________________________________________________________________| Adrenal Gland, Medulla | + + + + + + + + + + | __________________________________________________________________________| Islets, Pancreatic | + + + + + + + + + A + | __________________________________________________________________________| Parathyroid Gland | + + + + M M M M + + | __________________________________________________________________________| Pituitary Gland | M + + + + + + + + + | Pars Distalis, Angiectasis | 2 | Pars Distalis, Hyperplasia | 2 2 | __________________________________________________________________________| Thyroid Gland | + + + + + + + + + + | Follicle, Ectasia | 2 | Follicle, Hyperplasia | 3 | _____________________________________________________________________________________________________________________| GENERAL BODY SYSTEM | | | | None | | _____________________________________________________________________________________________________________________| GENITAL SYSTEM | | | | __________________________________________________________________________| Ovary | + + + + + + + + + + + + + + + + + | Abscess | 4 4 4 4 4 4 | Follicle, Cyst | | Periovarian Tissue, Cyst | 2 2 X 2 | __________________________________________________________________________| Uterus | + + + + + + + + + + + + + + + + + + + + + +| Abscess | | Hydrometra | 3 | Endometrium, Angiectasis | | Endometrium, Hyperplasia, Cystic | 1 3 3 2 4 3 2 4 4 2 3 3 3 3 2 3 3 3 3| Endometrium, Inflammation, Acute | 4 2 2 3 4 2 2| Endometrium, Metaplasia, Squamous | 2 | __________________________________________________________________________| Vagina | + | _____________________________________________________________________________________________________________________| HEMATOPOIETIC SYSTEM | | | | __________________________________________________________________________| Bone Marrow | + + + + + + + + + + | Myelofibrosis | | Myeloid Cell, Hyperplasia | 2 2 2 2 2 2 3 | __________________________________________________________________________| Lymph Node | + + + + + + + + + + + + + + + | Iliac, Hyperplasia, Lymphoid | 3 | Mediastinal, Hyperplasia, Lymphoid | 2 | Mediastinal, Inflammation, Acute | | Pancreatic, Hyperplasia, Lymphoid | 2 | Renal, Hyperplasia, Lymphoid | 3 3 | Renal, Inflammation, Acute | | __________________________________________________________________________| Lymph Node, Mandibular | M + M + + + + + M + | Hyperplasia, Lymphoid | 2 2 2 | Pigmentation | 2 | __________________________________________________________________________| Lymph Node, Mesenteric | + + + + + + + + + + + + + | Congestion | 2 | Hyperplasia, Lymphoid | 2 2 2 2 | _____________________________________________________________________________________________________________________| Page 38 NTP Experiment-Test: 05007-05 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 08:05:11 _____________________________________________________________________________________________________________________ | 1| 4| 7| 7| 7| 2| 7| 7| 7| 7| 6| 6| 7| 7| 7| 5| 6| 7| 7| 7| 1| 7| 7| 7| 7| DAY ON TEST | 1| 9| 3| 3| 3| 4| 0| 3| 3| 3| 3| 3| 3| 3| 3| 8| 2| 3| 3| 3| 9| 0| 3| 3| 3| | 4| 8| 4| 4| 4| 7| 7| 5| 5| 5| 7| 8| 5| 5| 5| 8| 8| 5| 5| 5| 2| 6| 5| 5| 5| _____________________________________________________________________________________________________________________| | 0| 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 | 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 2.5% | 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 0| 0| 0| 0| 0| | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| _____________________________________________________________________________________________________________________| HEMATOPOIETIC SYSTEM - cont | | | | __________________________________________________________________________| Spleen | M + + + + + + + + + + + + | Hematopoietic Cell Proliferation | 3 3 2 3 2 3 3 | Hyperplasia, Lymphoid | 2 2 2 2 | Inflammation, Acute | 4 | Pigmentation | 2 2 2 | Capsule, Inflammation, Chronic | | __________________________________________________________________________| Thymus | + + + + + + + + + + | Hyperplasia, Lymphoid | 2 | _____________________________________________________________________________________________________________________| INTEGUMENTARY SYSTEM | | | | __________________________________________________________________________| Mammary Gland | M + M + + + + + M + | Acinus, Ectasia | 1 | Duct, Ectasia | | __________________________________________________________________________| Skin | + + + + + + + + + + + + + + + + + + +| Inflammation, Chronic | 2 | Head, Ulcer | 3 | _____________________________________________________________________________________________________________________| MUSCULOSKELETAL SYSTEM | | | | __________________________________________________________________________| Bone | + + + + + + + + + + | _____________________________________________________________________________________________________________________| NERVOUS SYSTEM | | | | __________________________________________________________________________| Brain | + + + + + + + + + + | Hydrocephalus | | Mineralization | 1 | _____________________________________________________________________________________________________________________| RESPIRATORY SYSTEM | | | | __________________________________________________________________________| Lung | + + + + + + + + + + | Congestion | 4 2 | Hemorrhage | | Infiltration Cellular, Lymphocyte | 2 2 2 2 2 2 2 | Alveolus, Infiltration Cellular, | | Histiocyte | 2 | Interstitium, Inflammation, Acute | | Mediastinum, Inflammation, Acute | | Peribronchial, Inflammation, Acute | | Pleura, Inflammation, Acute | | __________________________________________________________________________| Nose | + + + + + + + + + + | Lumen, Hemorrhage | 2 2 2 | Nasolacrimal Duct, Hemorrhage | | Olfactory Epithelium, Degeneration | 2 2 2 2 2 2 2 2 | __________________________________________________________________________| Trachea | + + + + + + + + + + | _____________________________________________________________________________________________________________________| SPECIAL SENSES SYSTEM | | | | __________________________________________________________________________| Eye | | _____________________________________________________________________________________________________________________| Page 39 NTP Experiment-Test: 05007-05 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 08:05:11 _____________________________________________________________________________________________________________________ | 1| 4| 7| 7| 7| 2| 7| 7| 7| 7| 6| 6| 7| 7| 7| 5| 6| 7| 7| 7| 1| 7| 7| 7| 7| DAY ON TEST | 1| 9| 3| 3| 3| 4| 0| 3| 3| 3| 3| 3| 3| 3| 3| 8| 2| 3| 3| 3| 9| 0| 3| 3| 3| | 4| 8| 4| 4| 4| 7| 7| 5| 5| 5| 7| 8| 5| 5| 5| 8| 8| 5| 5| 5| 2| 6| 5| 5| 5| _____________________________________________________________________________________________________________________| | 0| 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 | 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 2.5% | 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 0| 0| 0| 0| 0| | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| _____________________________________________________________________________________________________________________| SPECIAL SENSES SYSTEM - cont | | | | _____________________________________________________________________________________________________________________| URINARY SYSTEM | | | | __________________________________________________________________________| Kidney | + + + + + + + + + + + | Amyloid Deposition | 4 | Infiltration Cellular, Lymphocyte | 2 2 2 2 2 2 | Inflammation, Acute | 4 | Inflammation, Chronic Active | 3 | Renal Tubule, Casts Protein | | Renal Tubule, Ectasia | | Renal Tubule, Mineralization | | __________________________________________________________________________| Urinary Bladder | + + + M + + + + M + | Infiltration Cellular, Lymphocyte | 2 2 2 2 2 | _____________________________________________________________________________________________________________________| Page 40 NTP Experiment-Test: 05007-05 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 08:05:11 __________________________________________________________________________________________________________________________________ | 4| 4| 4| 4| 4| 4| 6| 7| 7| 7| | | DAY ON TEST | 5| 5| 5| 5| 5| 3| 3| 0| 3| 3| | | | 8| 8| 8| 8| 8| 7| 9| 7| 5| 5| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | B6C3F1 MICE FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| | A | 2.5% | 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| | L | | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| | | __________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM | | | | | | __________________________________________________________________________|____________| Esophagus | + + + | 22 | __________________________________________________________________________|____________| Gallbladder | + + + | 18 | Infiltration Cellular, Lymphocyte | | 2 2.0| __________________________________________________________________________|____________| Intestine Large | M + + | 18 | __________________________________________________________________________|____________| Intestine Large, Cecum | M + + | 18 | __________________________________________________________________________|____________| Intestine Large, Colon | M + + | 18 | __________________________________________________________________________|____________| Intestine Large, Rectum | M + + | 17 | __________________________________________________________________________|____________| Intestine Small | + + + | 20 | __________________________________________________________________________|____________| Intestine Small, Duodenum | + + + | 19 | __________________________________________________________________________|____________| Intestine Small, Ileum | M + + | 18 | __________________________________________________________________________|____________| Intestine Small, Jejunum | M + + | 19 | __________________________________________________________________________|____________| Liver | + + + | 25 | Hematopoietic Cell Proliferation | 2 2 | 6 1.8| Infiltration Cellular, Lymphocyte | | 4 1.5| Inflammation, Acute | 2 | 1 2.0| Necrosis | 3 | 3 3.0| __________________________________________________________________________|____________| Mesentery | + + | 5 | Cyst | X | 1 | Inflammation, Acute | 3 | 3 3.0| __________________________________________________________________________|____________| Pancreas | + + + | 22 | Infiltration Cellular, Lymphocyte | | 1 1.0| Inflammation, Chronic Active | | 1 3.0| Acinus, Atrophy | | 1 1.0| __________________________________________________________________________|____________| Salivary Glands | M + + | 18 | Infiltration Cellular, Lymphocyte | 2 2 | 12 2.0| __________________________________________________________________________|____________| Stomach | + + + + + | 50 | __________________________________________________________________________|____________| Stomach, Forestomach | + + + + + | 50 | Cyst Epithelial Inclusion | | 1 | Erosion | | 1 2.0| Hyperplasia, Squamous | | 8 1.8| Inflammation, Acute | | 4 2.0| __________________________________________________________________________|____________| Stomach, Glandular | + + + + + | 49 | Infiltration Cellular, Lymphocyte | 2 2 2 | 9 2.0| Mineralization | | 2 1.5| _____________________________________________________________________________________________________________________| | CARDIOVASCULAR SYSTEM | | | | | | __________________________________________________________________________|____________| Heart | + + + | 22 | Infiltration Cellular, Lymphocyte | 2 | 3 2.0| _____________________________________________________________________________________________________________________| | 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 41 NTP Experiment-Test: 05007-05 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 08:05:11 __________________________________________________________________________________________________________________________________ | 4| 4| 4| 4| 4| 4| 6| 7| 7| 7| | | DAY ON TEST | 5| 5| 5| 5| 5| 3| 3| 0| 3| 3| | | | 8| 8| 8| 8| 8| 7| 9| 7| 5| 5| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | B6C3F1 MICE FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| | A | 2.5% | 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| | L | | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| | | __________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM - cont | | | | | | | | | __________________________________________________________________________|____________| Adrenal Gland | + + + | 22 | __________________________________________________________________________|____________| Adrenal Gland, Cortex | + + + | 22 | Pigmentation | | 5 1.4| Spindle Cell, Hyperplasia | 2 2 2 | 22 2.0| __________________________________________________________________________|____________| Adrenal Gland, Medulla | + + + | 22 | __________________________________________________________________________|____________| Islets, Pancreatic | + + + | 21 | __________________________________________________________________________|____________| Parathyroid Gland | M M M | 9 | __________________________________________________________________________|____________| Pituitary Gland | M + + + | 20 | Pars Distalis, Angiectasis | | 2 2.0| Pars Distalis, Hyperplasia | | 3 2.0| __________________________________________________________________________|____________| Thyroid Gland | M + + | 19 | Follicle, Ectasia | 2 | 2 2.0| Follicle, Hyperplasia | | 1 3.0| _____________________________________________________________________________________________________________________| | GENERAL BODY SYSTEM | | | | | | None | | | _____________________________________________________________________________________________________________________| | GENITAL SYSTEM | | | | | | __________________________________________________________________________|____________| Ovary | + + + + + | 36 | Abscess | 4 4 | 13 4.0| Follicle, Cyst | | 1 2.0| Periovarian Tissue, Cyst | 2 2 2 | 13 2.0| __________________________________________________________________________|____________| Uterus | + + + + | 42 | Abscess | 4 | 3 3.7| Hydrometra | | 1 3.0| Endometrium, Angiectasis | | 1 2.0| Endometrium, Hyperplasia, Cystic | 2 3 3 2 | 37 2.6| Endometrium, Inflammation, Acute | 4 | 10 2.7| Endometrium, Metaplasia, Squamous | | 1 2.0| __________________________________________________________________________|____________| Vagina | | 4 | _____________________________________________________________________________________________________________________| | HEMATOPOIETIC SYSTEM | | | | | | __________________________________________________________________________|____________| Bone Marrow | + + + | 22 | Myelofibrosis | | 1 2.0| Myeloid Cell, Hyperplasia | 2 2 | 14 2.1| __________________________________________________________________________|____________| Lymph Node | + + + | 26 | Iliac, Hyperplasia, Lymphoid | | 1 3.0| Mediastinal, Hyperplasia, Lymphoid | 2 | 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 42 NTP Experiment-Test: 05007-05 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 08:05:11 __________________________________________________________________________________________________________________________________ | 4| 4| 4| 4| 4| 4| 6| 7| 7| 7| | | DAY ON TEST | 5| 5| 5| 5| 5| 3| 3| 0| 3| 3| | | | 8| 8| 8| 8| 8| 7| 9| 7| 5| 5| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | B6C3F1 MICE FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| | A | 2.5% | 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| | L | | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| | | __________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - cont | | | | | | Mediastinal, Inflammation, Acute | | 1 4.0| Pancreatic, Hyperplasia, Lymphoid | | 1 2.0| Renal, Hyperplasia, Lymphoid | 3 3 | 6 3.0| Renal, Inflammation, Acute | | 2 3.5| __________________________________________________________________________|____________| Lymph Node, Mandibular | M + + | 16 | Hyperplasia, Lymphoid | 2 2 | 9 2.0| Pigmentation | | 1 2.0| __________________________________________________________________________|____________| Lymph Node, Mesenteric | M + + | 23 | Congestion | | 2 2.5| Hyperplasia, Lymphoid | 3 | 9 2.2| __________________________________________________________________________|____________| Spleen | + + + | 25 | Hematopoietic Cell Proliferation | 2 2 3 | 18 2.7| Hyperplasia, Lymphoid | 2 | 5 2.0| Inflammation, Acute | | 1 4.0| Pigmentation | 2 | 4 2.0| Capsule, Inflammation, Chronic | | 1 3.0| __________________________________________________________________________|____________| Thymus | M + + | 20 | Hyperplasia, Lymphoid | 2 2 | 6 2.0| _____________________________________________________________________________________________________________________| | INTEGUMENTARY SYSTEM | | | | | | __________________________________________________________________________|____________| Mammary Gland | + + + | 19 | Acinus, Ectasia | | 1 1.0| Duct, Ectasia | 2 2 | 5 1.8| __________________________________________________________________________|____________| Skin | + + + | 38 | Inflammation, Chronic | 2 | 6 2.0| Head, Ulcer | | 1 3.0| _____________________________________________________________________________________________________________________| | MUSCULOSKELETAL SYSTEM | | | | | | __________________________________________________________________________|____________| Bone | + + + | 22 | _____________________________________________________________________________________________________________________| | NERVOUS SYSTEM | | | | | | __________________________________________________________________________|____________| Brain | + + + | 22 | Hydrocephalus | 3 | 1 3.0| Mineralization | 2 2 | 9 1.4| _____________________________________________________________________________________________________________________| | RESPIRATORY SYSTEM | | | | | | __________________________________________________________________________|____________| Lung | + + + | 22 | Congestion | 3 | 4 2.8| Hemorrhage | | 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 43 NTP Experiment-Test: 05007-05 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 08:05:11 __________________________________________________________________________________________________________________________________ | 4| 4| 4| 4| 4| 4| 6| 7| 7| 7| | | DAY ON TEST | 5| 5| 5| 5| 5| 3| 3| 0| 3| 3| | | | 8| 8| 8| 8| 8| 7| 9| 7| 5| 5| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | B6C3F1 MICE FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| | A | 2.5% | 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| | L | | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| | | __________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM - cont | | | | | | Infiltration Cellular, Lymphocyte | 2 2 2 | 18 1.9| Alveolus, Infiltration Cellular, | | | Histiocyte | | 2 2.0| Interstitium, Inflammation, Acute | | 2 2.5| Mediastinum, Inflammation, Acute | | 1 3.0| Peribronchial, Inflammation, Acute | 2 | 1 2.0| Pleura, Inflammation, Acute | | 1 3.0| __________________________________________________________________________|____________| Nose | + + + | 22 | Lumen, Hemorrhage | 2 | 5 2.0| Nasolacrimal Duct, Hemorrhage | | 1 2.0| Olfactory Epithelium, Degeneration | 2 2 | 19 1.9| __________________________________________________________________________|____________| Trachea | M + + | 21 | _____________________________________________________________________________________________________________________| | SPECIAL SENSES SYSTEM | | | | | | __________________________________________________________________________|____________| Eye | | 1 | _____________________________________________________________________________________________________________________| | URINARY SYSTEM | | | | | | __________________________________________________________________________|____________| Kidney | + + + | 23 | Amyloid Deposition | | 1 4.0| Infiltration Cellular, Lymphocyte | 2 2 | 14 1.9| Inflammation, Acute | | 2 4.0| Inflammation, Chronic Active | | 1 3.0| Renal Tubule, Casts Protein | | 1 2.0| Renal Tubule, Ectasia | | 2 1.5| Renal Tubule, Mineralization | | 1 2.0| __________________________________________________________________________|____________| Urinary Bladder | M + + | 18 | Infiltration Cellular, Lymphocyte | 2 2 | 11 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 44 NTP Experiment-Test: 05007-05 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 08:05:11 _____________________________________________________________________________________________________________________ | 7| 6| 6| 7| 7| 7| 7| 4| 5| 6| 7| 2| 7| 7| 7| 0| 7| 6| 7| 7| 1| 4| 4| 4| 4| DAY ON TEST | 2| 5| 3| 2| 2| 2| 2| 3| 3| 4| 2| 6| 1| 2| 2| 9| 2| 3| 2| 2| 6| 5| 5| 5| 5| | 9| 4| 7| 9| 9| 9| 9| 6| 8| 0| 9| 0| 5| 9| 9| 0| 9| 4| 9| 9| 8| 7| 7| 7| 7| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 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| UNTREATD | 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 5| 5| 5| 5| 5| CONTROL | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| _____________________________________________________________________________________________________________________| ALIMENTARY SYSTEM | | | | __________________________________________________________________________| Esophagus | + + + + + + + + + + + + + + + + + + + + | __________________________________________________________________________| Gallbladder | + + + + + M + + + + + + + M + M + + + + | Infiltration Cellular, Lymphocyte | 2 2 2 | __________________________________________________________________________| Intestine Large | + + + + + + + + + + + + + + + A + + + + | __________________________________________________________________________| Intestine Large, Cecum | + + + + + + + + + + + + + + + A + + + + | __________________________________________________________________________| Intestine Large, Colon | + + + + + + + + + + + + + + + A + + + + | __________________________________________________________________________| Intestine Large, Rectum | + + + + + + + + + + + + + + + A + + + + | __________________________________________________________________________| Intestine Small | + + + + + + + + + + + + + + + A + + + + | __________________________________________________________________________| Intestine Small, Duodenum | + + + + + + + + + + + + + + + A + + + + | __________________________________________________________________________| Intestine Small, Ileum | + + + + + + + + + + + + + + + A + + + + | Inflammation, Acute | 3 | __________________________________________________________________________| Intestine Small, Jejunum | + + + + + + + + + + + + + + + A + + + + | __________________________________________________________________________| Liver | + + + + + + + + + + + + + + + + + + + + | Cytomegaly | | Fatty Change | 2 | Focal Cellular Change | X | Hematopoietic Cell Proliferation | 2 1 | Infiltration Cellular, Lymphocyte | 1 2 2 1 2 | Necrosis | 2 4 | Vacuolization Cytoplasmic | | Portal, Inflammation, Chronic | 3 2 | __________________________________________________________________________| Mesentery | + | Fat, Necrosis | 3 | __________________________________________________________________________| Pancreas | + + + + + + + + + + + + + + + + + + + + | Infiltration Cellular | 2 | Infiltration Cellular, Lymphocyte | 2 | Acinus, Hyperplasia | | __________________________________________________________________________| Salivary Glands | + + + + + + + + + + + + + + + + + + + + | Infiltration Cellular, Lymphocyte | 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 | Acinus, Atrophy | 3 | __________________________________________________________________________| Stomach | + + + + + + + + + + + + + + + + + + + + | __________________________________________________________________________| Stomach, Forestomach | + + + + + + + + + + + + + + + + + + + + | Hyperplasia, Squamous | 2 3 | Infiltration Cellular, Lymphocyte | 1 2 | Mineralization | 2 | Ulcer | 2 | Epithelium, Hyperplasia | | __________________________________________________________________________| Stomach, Glandular | + + + + + + + + + + + + + + + + + + + + | Infiltration Cellular, Lymphocyte | 2 2 2 2 2 | Inflammation, Acute | 3 | Inflammation, Chronic Active | | Mineralization | 2 2 | Mucosa, Ectasia | | Mucosa, Erosion | 2 | _____________________________________________________________________________________________________________________| Page 45 NTP Experiment-Test: 05007-05 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 08:05:11 _____________________________________________________________________________________________________________________ | 7| 6| 6| 7| 7| 7| 7| 4| 5| 6| 7| 2| 7| 7| 7| 0| 7| 6| 7| 7| 1| 4| 4| 4| 4| DAY ON TEST | 2| 5| 3| 2| 2| 2| 2| 3| 3| 4| 2| 6| 1| 2| 2| 9| 2| 3| 2| 2| 6| 5| 5| 5| 5| | 9| 4| 7| 9| 9| 9| 9| 6| 8| 0| 9| 0| 5| 9| 9| 0| 9| 4| 9| 9| 8| 7| 7| 7| 7| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 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| UNTREATD | 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 5| 5| 5| 5| 5| CONTROL | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| _____________________________________________________________________________________________________________________| ALIMENTARY SYSTEM - cont | | | | __________________________________________________________________________| Tooth | + | Pulp, Inflammation, Chronic Active | 3 | _____________________________________________________________________________________________________________________| CARDIOVASCULAR SYSTEM | | | | __________________________________________________________________________| Heart | + + + + + + + + + + + + + + + + + + + + | Infiltration Cellular, Lymphocyte | 2 1 | _____________________________________________________________________________________________________________________| ENDOCRINE SYSTEM | | | | __________________________________________________________________________| Adrenal Gland | + + + + + + + + + + + + + + + + + + + + | __________________________________________________________________________| Adrenal Gland, Cortex | + + + + + + + + + + + + + + + + + + + + | Cyst | | Hypertrophy | 2 | Spindle Cell, Hyperplasia | 2 2 2 1 2 2 2 2 2 2 1 2 2 2 2 2 2 2 2 2 | __________________________________________________________________________| Adrenal Gland, Medulla | + + + + + + + + + + + + + + + + + + + + | Hyperplasia | 2 2 | __________________________________________________________________________| Islets, Pancreatic | + + + + + + + + + + + + + + + + + + + + | __________________________________________________________________________| Parathyroid Gland | + M + M + + + + M M M + M M M + M M + M | __________________________________________________________________________| Pituitary Gland | + + + + + + + + + + + + + + + + + + + + | Pars Distalis, Hyperplasia | 2 | Pars Intermedia, Cyst | | __________________________________________________________________________| Thyroid Gland | + + + + + + + + + + + + + + + + + + + + | Infiltration Cellular, Lymphocyte | 2 | Ultimobranchial Cyst | X | C-Cell, Hyperplasia | | Follicle, Ectasia | | Follicle, Hyperplasia | | _____________________________________________________________________________________________________________________| GENERAL BODY SYSTEM | | | | None | | _____________________________________________________________________________________________________________________| GENITAL SYSTEM | | | | __________________________________________________________________________| Epididymis | + + + + + + + + + + + + + + + + + + + + | Infiltration Cellular, Lymphocyte | 2 2 2 | __________________________________________________________________________| Penis | + | Inflammation, Acute | 4 | __________________________________________________________________________| Preputial Gland | + + + + + + | Abscess | 4 4 | Inflammation, Chronic | | Inflammation, Chronic Active | 3 4 3 | Duct, Cyst | | __________________________________________________________________________| Prostate | + + + + + + + + + + + + + + + + + + + + | Ectasia | 2 | Infiltration Cellular, Lymphocyte | | Inflammation, Chronic | 2 | _____________________________________________________________________________________________________________________| Page 46 NTP Experiment-Test: 05007-05 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 08:05:11 _____________________________________________________________________________________________________________________ | 7| 6| 6| 7| 7| 7| 7| 4| 5| 6| 7| 2| 7| 7| 7| 0| 7| 6| 7| 7| 1| 4| 4| 4| 4| DAY ON TEST | 2| 5| 3| 2| 2| 2| 2| 3| 3| 4| 2| 6| 1| 2| 2| 9| 2| 3| 2| 2| 6| 5| 5| 5| 5| | 9| 4| 7| 9| 9| 9| 9| 6| 8| 0| 9| 0| 5| 9| 9| 0| 9| 4| 9| 9| 8| 7| 7| 7| 7| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 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| UNTREATD | 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 5| 5| 5| 5| 5| CONTROL | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| _____________________________________________________________________________________________________________________| GENITAL SYSTEM - cont | | | | Inflammation, Chronic Active | | __________________________________________________________________________| Seminal Vesicle | + + + + + + + + + + + + + + + + + + + + | Ectasia | | Infiltration Cellular, Lymphocyte | 2 2 | __________________________________________________________________________| Testes | + + + + + + + + + + + + + + + + + + + + | Mineralization | 2 | Interstitial Cell, Hyperplasia | 2 2 2 2 2 | Seminiferous Tubule, Mineralization | 2 | _____________________________________________________________________________________________________________________| HEMATOPOIETIC SYSTEM | | | | __________________________________________________________________________| Blood | | Atypia Cellular | | __________________________________________________________________________| Bone Marrow | + + + + + + + + + + + + + + + + + + + + | Myelofibrosis | 2 2 | Myeloid Cell, Hyperplasia | 2 2 2 2 2 2 2 2 2 2 2 2 2 | __________________________________________________________________________| Lymph Node | + + + + + + + + + + + + + + + + + + + + | Inguinal, Hyperplasia, Lymphoid | 2 | __________________________________________________________________________| Lymph Node, Mandibular | + + + + + + + + + + + + + + + + + + + + | Hyperplasia, Lymphoid | 2 2 2 2 2 2 2 2 2 2 2 2 2 1 2 | Pigmentation | 2 2 2 2 2 2 | __________________________________________________________________________| Lymph Node, Mesenteric | + + + + + + + + + + + + + + + + + + + + | Congestion | 4 2 3 | Hemorrhage | 3 | Hyperplasia, Lymphoid | 2 2 3 3 2 2 3 2 2 2 2 2 | Hyperplasia | | Inflammation, Acute | 2 3 2 3 | __________________________________________________________________________| Spleen | + + + + + + + + + + + + + + + + + + + + | Angiectasis | | Hematopoietic Cell Proliferation | 2 3 4 2 2 4 4 4 2 4 2 3 2 | Hyperplasia, Lymphoid | 2 2 2 2 | Pigmentation | 1 1 2 | __________________________________________________________________________| Thymus | + + + + + + + + + + + + + + + + + + + + | Cyst | X X X X | _____________________________________________________________________________________________________________________| INTEGUMENTARY SYSTEM | | | | __________________________________________________________________________| Mammary Gland | M M M M M M M M M M M M M M M M M M M M | __________________________________________________________________________| Skin | + + + + + + + + + + + + + + + + + + + + | Erosion | 2 | Inflammation, Chronic | 3 3 3 2 1 3 2 2 2 3 | Inflammation, Chronic Active | | Metaplasia, Osseous | | Ulcer | 4 4 | Subcutaneous Tissue, Abscess | | _____________________________________________________________________________________________________________________| MUSCULOSKELETAL SYSTEM | | _____________________________________________________________________________________________________________________| Page 47 NTP Experiment-Test: 05007-05 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 08:05:11 _____________________________________________________________________________________________________________________ | 7| 6| 6| 7| 7| 7| 7| 4| 5| 6| 7| 2| 7| 7| 7| 0| 7| 6| 7| 7| 1| 4| 4| 4| 4| DAY ON TEST | 2| 5| 3| 2| 2| 2| 2| 3| 3| 4| 2| 6| 1| 2| 2| 9| 2| 3| 2| 2| 6| 5| 5| 5| 5| | 9| 4| 7| 9| 9| 9| 9| 6| 8| 0| 9| 0| 5| 9| 9| 0| 9| 4| 9| 9| 8| 7| 7| 7| 7| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 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| UNTREATD | 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 5| 5| 5| 5| 5| CONTROL | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| _____________________________________________________________________________________________________________________| MUSCULOSKELETAL SYSTEM - cont | | | | | | __________________________________________________________________________| Bone | + + + + + + + + + + + + + + + + + + + + | _____________________________________________________________________________________________________________________| NERVOUS SYSTEM | | | | __________________________________________________________________________| Brain | + + + + + + + + + + + + + + + + + + + + | Mineralization | 2 2 2 2 2 2 2 2 1 2 2 2 2 2 2 2 | _____________________________________________________________________________________________________________________| RESPIRATORY SYSTEM | | | | __________________________________________________________________________| Lung | + + + + + + + + + + + + + + + + + + + + | Congestion | 3 2 | Hemorrhage | 1 2 | Infiltration Cellular, Lymphocyte | 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 | Infiltration Cellular, Histiocyte | 2 | Alveolar Epithelium, Hyperplasia | 2 3 | Alveolus, Infiltration Cellular, | | Histiocyte | 2 2 2 | Alveolus, Inflammation, Acute | | Bronchiole, Inflammation, Acute | 1 1 | Bronchiole, Inflammation, Chronic | | Active | 2 | Interstitium, Inflammation, Acute | 2 | __________________________________________________________________________| Nose | + + + + + + + + + + + + + + + + + + + + | Lumen, Hemorrhage | 2 3 2 2 2 2 2 2 | Mucosa, Inflammation, Acute | | Nasolacrimal Duct, Hemorrhage | 2 | Nasolacrimal Duct, Inflammation, | | Acute | 2 | Olfactory Epithelium, Degeneration | 2 2 2 2 2 2 | Respiratory Epithelium, Degeneration | | __________________________________________________________________________| Trachea | + + + + + + + + + + + + + + + + + + + + | _____________________________________________________________________________________________________________________| SPECIAL SENSES SYSTEM | | | | __________________________________________________________________________| Eye | | _____________________________________________________________________________________________________________________| URINARY SYSTEM | | | | __________________________________________________________________________| Kidney | + + + + + + + + + + + + + + + + + + + + | Infiltration Cellular, Lymphocyte | 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 3 | Metaplasia, Osseous | | Glomerulus, Ectasia | 2 | Renal Tubule, Casts Protein | 1 2 1 2 | Renal Tubule, Ectasia | 1 2 2 2 | Renal Tubule, Mineralization | 1 2 2 2 | Renal Tubule, Necrosis | 1 2 2 1 1 2 1 | Renal Tubule, Pigmentation | | _____________________________________________________________________________________________________________________| Page 48 NTP Experiment-Test: 05007-05 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 08:05:11 _____________________________________________________________________________________________________________________ | 7| 6| 6| 7| 7| 7| 7| 4| 5| 6| 7| 2| 7| 7| 7| 0| 7| 6| 7| 7| 1| 4| 4| 4| 4| DAY ON TEST | 2| 5| 3| 2| 2| 2| 2| 3| 3| 4| 2| 6| 1| 2| 2| 9| 2| 3| 2| 2| 6| 5| 5| 5| 5| | 9| 4| 7| 9| 9| 9| 9| 6| 8| 0| 9| 0| 5| 9| 9| 0| 9| 4| 9| 9| 8| 7| 7| 7| 7| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 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| UNTREATD | 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 5| 5| 5| 5| 5| CONTROL | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| _____________________________________________________________________________________________________________________| URINARY SYSTEM - cont | | | | Renal Tubule, Regeneration | 2 1 2 2 2 2 1 2 2 2 2 2 2 | __________________________________________________________________________| Urethra | + | Calculus Micro Observation Only | X | __________________________________________________________________________| Urinary Bladder | + + + + + + + + + + + + + + + + + + + + | Infiltration Cellular, Lymphocyte | 2 2 2 2 2 2 | _____________________________________________________________________________________________________________________| Page 49 NTP Experiment-Test: 05007-05 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 08:05:11 _____________________________________________________________________________________________________________________ | 4| 5| 5| 6| 7| 7| 7| 7| 7| 7| 7| 4| 7| 7| 7| 7| 7| 7| 7| 7| 2| 4| 4| 3| 4| DAY ON TEST | 4| 8| 7| 3| 2| 2| 0| 0| 2| 2| 2| 7| 2| 2| 2| 2| 3| 3| 3| 3| 7| 5| 5| 1| 5| | 0| 0| 5| 9| 9| 9| 7| 4| 9| 9| 9| 2| 9| 9| 9| 9| 0| 0| 0| 0| 2| 7| 7| 2| 7| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 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| 1| 1| 1| 1| 1| UNTREATD | 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 0| 0| 0| 0| 0| CONTROL | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| _____________________________________________________________________________________________________________________| ALIMENTARY SYSTEM | | | | __________________________________________________________________________| Esophagus | + + + + + + + + + + + + + + + + + + + | __________________________________________________________________________| Gallbladder | + + + + + + + + + + M + + + + + + M + | Infiltration Cellular, Lymphocyte | 2 2 2 2 2 2 | __________________________________________________________________________| Intestine Large | + + + + + + + + + + A + + + + + + + + | __________________________________________________________________________| Intestine Large, Cecum | + + + + + + + + + + A + + + + + + + + | __________________________________________________________________________| Intestine Large, Colon | + + + + + + + + + + A + + + + + + + + | __________________________________________________________________________| Intestine Large, Rectum | + + + + + + + + + + A + + + + + + + + | __________________________________________________________________________| Intestine Small | + + + + + + + + + + A + + + + + + + + | __________________________________________________________________________| Intestine Small, Duodenum | + + + + + + + + + + A + + + + + + + + | __________________________________________________________________________| Intestine Small, Ileum | + + + + + + + + + + A + + + + + + + + | Inflammation, Acute | | __________________________________________________________________________| Intestine Small, Jejunum | + + + + + + + + + + A + + + + + + + + | __________________________________________________________________________| Liver | + + + + + + + + + + + + + + + + + + + | Cytomegaly | 3 | Fatty Change | 1 2 | Focal Cellular Change | | Hematopoietic Cell Proliferation | 3 2 1 1 1 | Infiltration Cellular, Lymphocyte | 2 2 2 2 2 | Necrosis | 4 | Vacuolization Cytoplasmic | | Portal, Inflammation, Chronic | | __________________________________________________________________________| Mesentery | | Fat, Necrosis | | __________________________________________________________________________| Pancreas | + + + + + + + + + + A + + + + + + + + | Infiltration Cellular | | Infiltration Cellular, Lymphocyte | 2 2 2 | Acinus, Hyperplasia | | __________________________________________________________________________| Salivary Glands | + + + + + + + + + + + + + + + + + + + | Infiltration Cellular, Lymphocyte | 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 | Acinus, Atrophy | | __________________________________________________________________________| Stomach | + + + + + + + + + + A + + + + + + + + | __________________________________________________________________________| Stomach, Forestomach | + + + + + + + + + + A + + + + + + + + | Hyperplasia, Squamous | | Infiltration Cellular, Lymphocyte | 2 | Mineralization | | Ulcer | | Epithelium, Hyperplasia | | __________________________________________________________________________| Stomach, Glandular | + + + + + + + + + + A + + + + + + + + | Infiltration Cellular, Lymphocyte | 2 2 2 | Inflammation, Acute | 1 3 2 2 | Inflammation, Chronic Active | 1 | Mineralization | | Mucosa, Ectasia | 2 2 | Mucosa, Erosion | 2 2 | _____________________________________________________________________________________________________________________| Page 50 NTP Experiment-Test: 05007-05 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 08:05:11 _____________________________________________________________________________________________________________________ | 4| 5| 5| 6| 7| 7| 7| 7| 7| 7| 7| 4| 7| 7| 7| 7| 7| 7| 7| 7| 2| 4| 4| 3| 4| DAY ON TEST | 4| 8| 7| 3| 2| 2| 0| 0| 2| 2| 2| 7| 2| 2| 2| 2| 3| 3| 3| 3| 7| 5| 5| 1| 5| | 0| 0| 5| 9| 9| 9| 7| 4| 9| 9| 9| 2| 9| 9| 9| 9| 0| 0| 0| 0| 2| 7| 7| 2| 7| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 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| 1| 1| 1| 1| 1| UNTREATD | 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 0| 0| 0| 0| 0| CONTROL | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| _____________________________________________________________________________________________________________________| ALIMENTARY SYSTEM - cont | | | | __________________________________________________________________________| Tooth | | Pulp, Inflammation, Chronic Active | | _____________________________________________________________________________________________________________________| CARDIOVASCULAR SYSTEM | | | | __________________________________________________________________________| Heart | + + + + + + + + + + + + + + + + + + + | Infiltration Cellular, Lymphocyte | 2 1 1 | _____________________________________________________________________________________________________________________| ENDOCRINE SYSTEM | | | | __________________________________________________________________________| Adrenal Gland | + + + + + + + + + + + + + + + + + + + | __________________________________________________________________________| Adrenal Gland, Cortex | + + + + + + + + + + + + + + + + + + + | Cyst | | Hypertrophy | 2 2 | Spindle Cell, Hyperplasia | 2 2 2 2 2 2 2 2 2 1 2 2 2 2 2 2 2 2 | __________________________________________________________________________| Adrenal Gland, Medulla | + + + + + + + + + + + + + + + + + + + | Hyperplasia | | __________________________________________________________________________| Islets, Pancreatic | + + + + + + + + + + A + + + + + + + + | __________________________________________________________________________| Parathyroid Gland | + M M + M M M + + + + + + M M + M M M | __________________________________________________________________________| Pituitary Gland | + + + + + + + + + + M + + + + + + + + | Pars Distalis, Hyperplasia | 2 | Pars Intermedia, Cyst | | __________________________________________________________________________| Thyroid Gland | + + + + + + + + + + + + + + + + + + + | Infiltration Cellular, Lymphocyte | | Ultimobranchial Cyst | | C-Cell, Hyperplasia | | Follicle, Ectasia | 2 | Follicle, Hyperplasia | 2 1 2 2 | _____________________________________________________________________________________________________________________| GENERAL BODY SYSTEM | | | | None | | _____________________________________________________________________________________________________________________| GENITAL SYSTEM | | | | __________________________________________________________________________| Epididymis | + + + + + + + + + + + + + + + + + + + | Infiltration Cellular, Lymphocyte | 1 1 2 2 2 2 1 2 2 2 2 | __________________________________________________________________________| Penis | + | Inflammation, Acute | 4 | __________________________________________________________________________| Preputial Gland | + + + + + | Abscess | 4 | Inflammation, Chronic | 2 3 | Inflammation, Chronic Active | 3 | Duct, Cyst | X | __________________________________________________________________________| Prostate | + + + + + + + + + + + + + + + + + + + | Ectasia | | Infiltration Cellular, Lymphocyte | 2 | Inflammation, Chronic | | _____________________________________________________________________________________________________________________| Page 51 NTP Experiment-Test: 05007-05 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 08:05:11 _____________________________________________________________________________________________________________________ | 4| 5| 5| 6| 7| 7| 7| 7| 7| 7| 7| 4| 7| 7| 7| 7| 7| 7| 7| 7| 2| 4| 4| 3| 4| DAY ON TEST | 4| 8| 7| 3| 2| 2| 0| 0| 2| 2| 2| 7| 2| 2| 2| 2| 3| 3| 3| 3| 7| 5| 5| 1| 5| | 0| 0| 5| 9| 9| 9| 7| 4| 9| 9| 9| 2| 9| 9| 9| 9| 0| 0| 0| 0| 2| 7| 7| 2| 7| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 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| 1| 1| 1| 1| 1| UNTREATD | 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 0| 0| 0| 0| 0| CONTROL | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| _____________________________________________________________________________________________________________________| GENITAL SYSTEM - cont | | | | Inflammation, Chronic Active | 2 | __________________________________________________________________________| Seminal Vesicle | + + + + + + + + + + + + + + + + + + + | Ectasia | 2 | Infiltration Cellular, Lymphocyte | | __________________________________________________________________________| Testes | + + + + + + + + + + + + + + + + + + + | Mineralization | | Interstitial Cell, Hyperplasia | 2 2 2 2 2 2 2 2 | Seminiferous Tubule, Mineralization | | _____________________________________________________________________________________________________________________| HEMATOPOIETIC SYSTEM | | | | __________________________________________________________________________| Blood | + | Atypia Cellular | X | __________________________________________________________________________| Bone Marrow | + + + + + + + + + + + + + + + + + + + | Myelofibrosis | | Myeloid Cell, Hyperplasia | 2 2 2 2 2 2 2 2 2 2 2 2 2 | __________________________________________________________________________| Lymph Node | + + + + + + + + + + + + + + + + + + + | Inguinal, Hyperplasia, Lymphoid | | __________________________________________________________________________| Lymph Node, Mandibular | + + + + + + + + + + + + + + + + + + + | Hyperplasia, Lymphoid | 2 2 2 1 2 2 2 2 2 2 2 2 2 2 2 2 | Pigmentation | 2 2 2 | __________________________________________________________________________| Lymph Node, Mesenteric | + + + + + + + + + + A + + + + + + + + | Congestion | 3 3 2 3 2 | Hemorrhage | | Hyperplasia, Lymphoid | 2 2 2 2 2 2 2 2 2 2 2 2 2 | Hyperplasia | 2 | Inflammation, Acute | 2 | __________________________________________________________________________| Spleen | + + + + + + + + + + A + + + + + + + + | Angiectasis | 2 | Hematopoietic Cell Proliferation | 2 3 4 1 3 2 2 2 2 | Hyperplasia, Lymphoid | 2 2 2 | Pigmentation | 2 2 2 1 2 1 | __________________________________________________________________________| Thymus | + + + + + + + M + + + + + + + + + + + | Cyst | X | _____________________________________________________________________________________________________________________| INTEGUMENTARY SYSTEM | | | | __________________________________________________________________________| Mammary Gland | M M M M M M M M M M M M M M M M M M M | __________________________________________________________________________| Skin | + + + + + + + + + + + + + + + + + + + | Erosion | | Inflammation, Chronic | 3 3 3 3 3 2 2 | Inflammation, Chronic Active | 3 3 3 4 | Metaplasia, Osseous | 4 | Ulcer | 3 3 4 4 4 | Subcutaneous Tissue, Abscess | 4 | _____________________________________________________________________________________________________________________| MUSCULOSKELETAL SYSTEM | | _____________________________________________________________________________________________________________________| Page 52 NTP Experiment-Test: 05007-05 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 08:05:11 _____________________________________________________________________________________________________________________ | 4| 5| 5| 6| 7| 7| 7| 7| 7| 7| 7| 4| 7| 7| 7| 7| 7| 7| 7| 7| 2| 4| 4| 3| 4| DAY ON TEST | 4| 8| 7| 3| 2| 2| 0| 0| 2| 2| 2| 7| 2| 2| 2| 2| 3| 3| 3| 3| 7| 5| 5| 1| 5| | 0| 0| 5| 9| 9| 9| 7| 4| 9| 9| 9| 2| 9| 9| 9| 9| 0| 0| 0| 0| 2| 7| 7| 2| 7| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 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| 1| 1| 1| 1| 1| UNTREATD | 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 0| 0| 0| 0| 0| CONTROL | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| _____________________________________________________________________________________________________________________| MUSCULOSKELETAL SYSTEM - cont | | | | | | __________________________________________________________________________| Bone | + + + + + + + + + + + + + + + + + + + | _____________________________________________________________________________________________________________________| NERVOUS SYSTEM | | | | __________________________________________________________________________| Brain | + + + + + + + + + + + + + + + + + + + | Mineralization | 2 2 2 1 2 2 2 2 2 2 2 2 2 1 2 2 | _____________________________________________________________________________________________________________________| RESPIRATORY SYSTEM | | | | __________________________________________________________________________| Lung | + + + + + + + + + + + + + + + + + + + | Congestion | 2 | Hemorrhage | 1 2 | Infiltration Cellular, Lymphocyte | 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 | Infiltration Cellular, Histiocyte | | Alveolar Epithelium, Hyperplasia | 2 | Alveolus, Infiltration Cellular, | | Histiocyte | 3 | Alveolus, Inflammation, Acute | | Bronchiole, Inflammation, Acute | 1 | Bronchiole, Inflammation, Chronic | | Active | | Interstitium, Inflammation, Acute | | __________________________________________________________________________| Nose | + + + + + + + + + + + + + + + + + + + | Lumen, Hemorrhage | 2 2 2 2 2 1 1 2 2 2 | Mucosa, Inflammation, Acute | 2 | Nasolacrimal Duct, Hemorrhage | 1 | Nasolacrimal Duct, Inflammation, | | Acute | | Olfactory Epithelium, Degeneration | 2 2 2 2 2 2 2 2 1 1 2 2 2 | Respiratory Epithelium, Degeneration | 2 | __________________________________________________________________________| Trachea | + + + + + + + + + + + + + + + + + + + | _____________________________________________________________________________________________________________________| SPECIAL SENSES SYSTEM | | | | __________________________________________________________________________| Eye | | _____________________________________________________________________________________________________________________| URINARY SYSTEM | | | | __________________________________________________________________________| Kidney | + + + + + + + + + + + + + + + + + + + | Infiltration Cellular, Lymphocyte | 2 2 3 1 2 2 2 2 2 2 2 2 2 2 2 2 2 | Metaplasia, Osseous | 2 2 | Glomerulus, Ectasia | | Renal Tubule, Casts Protein | | Renal Tubule, Ectasia | 2 | Renal Tubule, Mineralization | 2 2 1 1 1 | Renal Tubule, Necrosis | 1 2 | Renal Tubule, Pigmentation | | _____________________________________________________________________________________________________________________| Page 53 NTP Experiment-Test: 05007-05 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 08:05:11 _____________________________________________________________________________________________________________________ | 4| 5| 5| 6| 7| 7| 7| 7| 7| 7| 7| 4| 7| 7| 7| 7| 7| 7| 7| 7| 2| 4| 4| 3| 4| DAY ON TEST | 4| 8| 7| 3| 2| 2| 0| 0| 2| 2| 2| 7| 2| 2| 2| 2| 3| 3| 3| 3| 7| 5| 5| 1| 5| | 0| 0| 5| 9| 9| 9| 7| 4| 9| 9| 9| 2| 9| 9| 9| 9| 0| 0| 0| 0| 2| 7| 7| 2| 7| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 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| 1| 1| 1| 1| 1| UNTREATD | 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 0| 0| 0| 0| 0| CONTROL | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| _____________________________________________________________________________________________________________________| URINARY SYSTEM - cont | | | | Renal Tubule, Regeneration | 2 2 2 1 2 2 2 1 2 1 2 2 2 | __________________________________________________________________________| Urethra | + + + + | Calculus Micro Observation Only | X X X X | __________________________________________________________________________| Urinary Bladder | + + + + + + + + + + A + + + + + + + + | Infiltration Cellular, Lymphocyte | 2 2 2 2 1 2 2 1 2 | _____________________________________________________________________________________________________________________| Page 54 NTP Experiment-Test: 05007-05 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 08:05:11 __________________________________________________________________________________________________________________________________ | 7| 7| 7| 7| 7| 4| 7| 7| 7| 7| | | DAY ON TEST | 3| 3| 3| 3| 3| 9| 3| 3| 3| 3| | | | 0| 0| 0| 0| 0| 2| 0| 0| 0| 0| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | B6C3F1 MICE MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| | A | UNTREATD | 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| | L | CONTROL | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| | | __________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM | | | | | | __________________________________________________________________________|____________| Esophagus | + + + + + + + + + + | 49 | __________________________________________________________________________|____________| Gallbladder | + + + + + + + + + + | 44 | Infiltration Cellular, Lymphocyte | 2 2 1 2 2 2 | 15 1.9| __________________________________________________________________________|____________| Intestine Large | + + + + + + + + + + | 47 | __________________________________________________________________________|____________| Intestine Large, Cecum | + + + + + + + + + + | 47 | __________________________________________________________________________|____________| Intestine Large, Colon | + + + + + A + + + + | 46 | __________________________________________________________________________|____________| Intestine Large, Rectum | + + + + + A + + + + | 46 | __________________________________________________________________________|____________| Intestine Small | + + + + + A + + + + | 46 | __________________________________________________________________________|____________| Intestine Small, Duodenum | + + + + + A + + + + | 46 | __________________________________________________________________________|____________| Intestine Small, Ileum | + + + + + A + + + + | 46 | Inflammation, Acute | | 1 3.0| __________________________________________________________________________|____________| Intestine Small, Jejunum | + + + + + A + + + + | 46 | __________________________________________________________________________|____________| Liver | + + + + + + + + + + | 49 | Cytomegaly | | 1 3.0| Fatty Change | | 3 1.7| Focal Cellular Change | X | 2 | Hematopoietic Cell Proliferation | 2 1 | 9 1.6| Infiltration Cellular, Lymphocyte | 2 2 | 12 1.8| Necrosis | | 3 3.3| Vacuolization Cytoplasmic | 1 | 1 1.0| Portal, Inflammation, Chronic | | 2 2.5| __________________________________________________________________________|____________| Mesentery | | 1 | Fat, Necrosis | | 1 3.0| __________________________________________________________________________|____________| Pancreas | + + + + + + + + + + | 48 | Infiltration Cellular | | 1 2.0| Infiltration Cellular, Lymphocyte | 2 2 1 | 7 1.9| Acinus, Hyperplasia | 2 | 1 2.0| __________________________________________________________________________|____________| Salivary Glands | + + + + + + + + + + | 49 | Infiltration Cellular, Lymphocyte | 2 2 2 2 2 2 2 | 38 2.0| Acinus, Atrophy | | 1 3.0| __________________________________________________________________________|____________| Stomach | + + + + + + + + + + | 48 | __________________________________________________________________________|____________| Stomach, Forestomach | + + + + + + + + + + | 48 | Hyperplasia, Squamous | 2 | 3 2.3| Infiltration Cellular, Lymphocyte | | 3 1.7| Mineralization | | 1 2.0| Ulcer | | 1 2.0| Epithelium, Hyperplasia | 2 | 1 2.0| __________________________________________________________________________|____________| Stomach, Glandular | + + + + + + + + + + | 48 | Infiltration Cellular, Lymphocyte | 2 2 2 2 1 | 13 1.9| __________________________________________________________________________________________________________________________________ * : 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 55 NTP Experiment-Test: 05007-05 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 08:05:11 __________________________________________________________________________________________________________________________________ | 7| 7| 7| 7| 7| 4| 7| 7| 7| 7| | | DAY ON TEST | 3| 3| 3| 3| 3| 9| 3| 3| 3| 3| | | | 0| 0| 0| 0| 0| 2| 0| 0| 0| 0| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | B6C3F1 MICE MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| | A | UNTREATD | 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| | L | CONTROL | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| | | __________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - cont | | | | | | Inflammation, Acute | | 5 2.2| Inflammation, Chronic Active | | 1 1.0| Mineralization | | 2 2.0| Mucosa, Ectasia | 2 1 | 4 1.8| Mucosa, Erosion | | 3 2.0| __________________________________________________________________________|____________| Tooth | | 1 | Pulp, Inflammation, Chronic Active | | 1 3.0| _____________________________________________________________________________________________________________________| | CARDIOVASCULAR SYSTEM | | | | | | __________________________________________________________________________|____________| Heart | + + + + + + + + + + | 49 | Infiltration Cellular, Lymphocyte | 1 | 6 1.3| _____________________________________________________________________________________________________________________| | ENDOCRINE SYSTEM | | | | | | __________________________________________________________________________|____________| Adrenal Gland | + + + + + + + + + + | 49 | __________________________________________________________________________|____________| Adrenal Gland, Cortex | + + + + + + + + + + | 49 | Cyst | X | 1 | Hypertrophy | 2 2 2 2 | 7 2.0| Spindle Cell, Hyperplasia | 2 2 2 2 2 2 2 2 2 2 | 48 1.9| __________________________________________________________________________|____________| Adrenal Gland, Medulla | + + + + + + + + + + | 49 | Hyperplasia | | 2 2.0| __________________________________________________________________________|____________| Islets, Pancreatic | + + + + + + + + + + | 48 | __________________________________________________________________________|____________| Parathyroid Gland | M + M M + + + + + + | 25 | __________________________________________________________________________|____________| Pituitary Gland | + + + + + M + + + + | 47 | Pars Distalis, Hyperplasia | | 2 2.0| Pars Intermedia, Cyst | X | 1 | __________________________________________________________________________|____________| Thyroid Gland | + + + + + + + + + + | 49 | Infiltration Cellular, Lymphocyte | | 1 2.0| Ultimobranchial Cyst | | 1 | C-Cell, Hyperplasia | 1 | 1 1.0| Follicle, Ectasia | | 1 2.0| Follicle, Hyperplasia | | 4 1.8| _____________________________________________________________________________________________________________________| | GENERAL BODY SYSTEM | | | | | | None | | | _____________________________________________________________________________________________________________________| | GENITAL SYSTEM | | | | | | __________________________________________________________________________|____________| Epididymis | + + + + + + + + + + | 49 | Infiltration Cellular, Lymphocyte | 2 2 2 2 2 | 19 1.8| __________________________________________________________________________|____________| Penis | | 2 | __________________________________________________________________________________________________________________________________ * : 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 56 NTP Experiment-Test: 05007-05 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 08:05:11 __________________________________________________________________________________________________________________________________ | 7| 7| 7| 7| 7| 4| 7| 7| 7| 7| | | DAY ON TEST | 3| 3| 3| 3| 3| 9| 3| 3| 3| 3| | | | 0| 0| 0| 0| 0| 2| 0| 0| 0| 0| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | B6C3F1 MICE MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| | A | UNTREATD | 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| | L | CONTROL | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| | | __________________________________________________________________________________________________________________________________ GENITAL SYSTEM - cont | | | | | | Inflammation, Acute | | 2 4.0| __________________________________________________________________________|____________| Preputial Gland | + + | 13 | Abscess | 4 | 4 4.0| Inflammation, Chronic | 3 | 3 2.7| Inflammation, Chronic Active | | 4 3.3| Duct, Cyst | | 1 | __________________________________________________________________________|____________| Prostate | + + + + + + + + + + | 49 | Ectasia | | 1 2.0| Infiltration Cellular, Lymphocyte | | 1 2.0| Inflammation, Chronic | | 1 2.0| Inflammation, Chronic Active | | 1 2.0| __________________________________________________________________________|____________| Seminal Vesicle | + + + + + + + + + + | 49 | Ectasia | | 1 2.0| Infiltration Cellular, Lymphocyte | | 2 2.0| __________________________________________________________________________|____________| Testes | + + + + + + + + + + | 49 | Mineralization | | 1 2.0| Interstitial Cell, Hyperplasia | 2 2 2 | 16 2.0| Seminiferous Tubule, Mineralization | | 1 2.0| _____________________________________________________________________________________________________________________| | HEMATOPOIETIC SYSTEM | | | | | | __________________________________________________________________________|____________| Blood | | 1 | Atypia Cellular | | 1 | __________________________________________________________________________|____________| Bone Marrow | + + + + + + + + + + | 49 | Myelofibrosis | | 2 2.0| Myeloid Cell, Hyperplasia | 2 2 2 2 2 2 2 2 2 | 35 2.0| __________________________________________________________________________|____________| Lymph Node | + + + + + + + + + + | 49 | Inguinal, Hyperplasia, Lymphoid | | 1 2.0| __________________________________________________________________________|____________| Lymph Node, Mandibular | + + + + + + + + + + | 49 | Hyperplasia, Lymphoid | 2 2 2 2 2 2 2 3 2 | 40 2.0| Pigmentation | 2 | 10 2.0| __________________________________________________________________________|____________| Lymph Node, Mesenteric | + + + + + + + + + + | 48 | Congestion | 2 2 2 2 | 12 2.5| Hemorrhage | | 1 3.0| Hyperplasia, Lymphoid | 2 2 3 2 2 2 2 2 | 33 2.1| Hyperplasia | | 1 2.0| Inflammation, Acute | | 5 2.4| __________________________________________________________________________|____________| Spleen | + + + + + + + + + + | 48 | Angiectasis | | 1 2.0| Hematopoietic Cell Proliferation | 2 2 2 1 | 26 2.5| __________________________________________________________________________________________________________________________________ * : 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 57 NTP Experiment-Test: 05007-05 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 08:05:11 __________________________________________________________________________________________________________________________________ | 7| 7| 7| 7| 7| 4| 7| 7| 7| 7| | | DAY ON TEST | 3| 3| 3| 3| 3| 9| 3| 3| 3| 3| | | | 0| 0| 0| 0| 0| 2| 0| 0| 0| 0| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | B6C3F1 MICE MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| | A | UNTREATD | 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| | L | CONTROL | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| | | __________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - cont | | | | | | Hyperplasia, Lymphoid | | 7 2.0| Pigmentation | 1 1 | 11 1.5| __________________________________________________________________________|____________| Thymus | + M + + + + + + + + | 47 | Cyst | X X X | 8 | _____________________________________________________________________________________________________________________| | INTEGUMENTARY SYSTEM | | | | | | __________________________________________________________________________|____________| Mammary Gland | M M M M M M M M M + | 1 | __________________________________________________________________________|____________| Skin | + + + + + + + + + + | 49 | Erosion | | 1 2.0| Inflammation, Chronic | 2 | 18 2.5| Inflammation, Chronic Active | | 4 3.3| Metaplasia, Osseous | | 1 4.0| Ulcer | 3 | 8 3.6| Subcutaneous Tissue, Abscess | | 1 4.0| _____________________________________________________________________________________________________________________| | MUSCULOSKELETAL SYSTEM | | | | | | __________________________________________________________________________|____________| Bone | + + + + + + + + + + | 49 | _____________________________________________________________________________________________________________________| | NERVOUS SYSTEM | | | | | | __________________________________________________________________________|____________| Brain | + + + + + + + + + + | 49 | Mineralization | 2 1 2 2 2 2 2 2 | 40 1.9| _____________________________________________________________________________________________________________________| | RESPIRATORY SYSTEM | | | | | | __________________________________________________________________________|____________| Lung | + + + + + + + + + + | 49 | Congestion | 2 | 4 2.3| Hemorrhage | 2 | 5 1.6| Infiltration Cellular, Lymphocyte | 2 2 2 1 2 2 1 2 2 2 | 42 2.0| Infiltration Cellular, Histiocyte | | 1 2.0| Alveolar Epithelium, Hyperplasia | 2 | 4 2.3| Alveolus, Infiltration Cellular, | | | Histiocyte | 2 2 | 6 2.2| Alveolus, Inflammation, Acute | 1 | 1 1.0| Bronchiole, Inflammation, Acute | 1 | 4 1.0| Bronchiole, Inflammation, Chronic | | | Active | | 1 2.0| Interstitium, Inflammation, Acute | | 1 2.0| __________________________________________________________________________|____________| Nose | + + + + + + + + + + | 49 | Lumen, Hemorrhage | 2 2 2 1 2 2 | 24 1.9| Mucosa, Inflammation, Acute | | 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 58 NTP Experiment-Test: 05007-05 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 08:05:11 __________________________________________________________________________________________________________________________________ | 7| 7| 7| 7| 7| 4| 7| 7| 7| 7| | | DAY ON TEST | 3| 3| 3| 3| 3| 9| 3| 3| 3| 3| | | | 0| 0| 0| 0| 0| 2| 0| 0| 0| 0| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | B6C3F1 MICE MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| | A | UNTREATD | 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| | L | CONTROL | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| | | __________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM - cont | | | | | | Nasolacrimal Duct, Hemorrhage | 2 | 3 1.7| Nasolacrimal Duct, Inflammation, | | | Acute | | 1 2.0| Olfactory Epithelium, Degeneration | 2 1 2 2 2 2 2 | 26 1.9| Respiratory Epithelium, Degeneration | | 1 2.0| __________________________________________________________________________|____________| Trachea | + + + + + + + + + + | 49 | _____________________________________________________________________________________________________________________| | SPECIAL SENSES SYSTEM | | | | | | __________________________________________________________________________|____________| Eye | + | 1 | _____________________________________________________________________________________________________________________| | URINARY SYSTEM | | | | | | __________________________________________________________________________|____________| Kidney | + + + + + + + + + + | 49 | Infiltration Cellular, Lymphocyte | 2 2 2 2 2 2 2 2 2 | 43 2.0| Metaplasia, Osseous | 2 | 3 2.0| Glomerulus, Ectasia | | 1 2.0| Renal Tubule, Casts Protein | | 4 1.5| Renal Tubule, Ectasia | 3 1 2 | 8 1.9| Renal Tubule, Mineralization | 2 2 2 | 12 1.7| Renal Tubule, Necrosis | 2 2 1 2 2 | 14 1.6| Renal Tubule, Pigmentation | 1 | 1 1.0| Renal Tubule, Regeneration | 2 2 2 2 2 2 1 | 33 1.8| __________________________________________________________________________|____________| Urethra | + + + + | 9 | Calculus Micro Observation Only | X X X X | 9 | __________________________________________________________________________|____________| Urinary Bladder | + + + + + A + + + + | 47 | Infiltration Cellular, Lymphocyte | 2 2 2 2 2 | 20 1.9| __________________________________________________________________________________________________________________________________ * : 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: 05007-05 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 08:05:11 _____________________________________________________________________________________________________________________ | 7| 7| 7| 7| 7| 7| 7| 7| 5| 6| 7| 7| 5| 7| 7| 4| 4| 4| 4| 4| 7| 7| 7| 7| 7| DAY ON TEST | 3| 3| 3| 3| 3| 3| 3| 1| 7| 3| 3| 3| 6| 3| 3| 5| 5| 5| 5| 5| 3| 3| 3| 3| 3| | 0| 0| 0| 0| 0| 1| 1| 5| 0| 7| 1| 1| 1| 1| 1| 7| 7| 7| 7| 7| 1| 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| 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| 5.0% | 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| _____________________________________________________________________________________________________________________| ALIMENTARY SYSTEM | | | | __________________________________________________________________________| Esophagus | + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Gallbladder | + + + + + + + + + + + + + + + + + + + +| Infiltration Cellular, Lymphocyte | 2 2 2 2 2 2 2 2 2 2| Epithelium, Degeneration | 2 | __________________________________________________________________________| Intestine Large | + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Large, Cecum | + + + + + + + + + + + + + + + + + + + +| Serosa, Inflammation, Chronic Active | | __________________________________________________________________________| Intestine Large, Colon | + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Large, Rectum | + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Small | + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Small, Duodenum | + + + + + + + + + + + + + + + + + + + +| Serosa, Inflammation, Chronic Active | | __________________________________________________________________________| Intestine Small, Ileum | + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Small, Jejunum | + + + + + + + + + + + + + + + + + + + +| Hyperplasia, Lymphoid | | Serosa, Inflammation, Chronic Active | | __________________________________________________________________________| Liver | + + + + + + + + + + + + + + + + + + + +| Angiectasis | | Focal Cellular Change | X | Hematopoietic Cell Proliferation | 3 1 1 1 | Infarct | 4 | Infiltration Cellular, Lymphocyte | 2 2 | Necrosis | 2 1 | Bile Duct, Cyst | X | Hepatocyte, Hypertrophy | | __________________________________________________________________________| Mesentery | | Hemorrhage | | Inflammation, Chronic | | Inflammation, Chronic Active | | __________________________________________________________________________| Pancreas | + + + + + + + + + + + + + + + + + + + +| Infiltration Cellular, Lymphocyte | 1 2 2 2 2 | Acinus, Atrophy | | Duct, Cyst | X| __________________________________________________________________________| Salivary Glands | + + + + + + + + + + + + + + + + + + + +| Infiltration Cellular, Lymphocyte | 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2| __________________________________________________________________________| Stomach | + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Stomach, Forestomach | + + + + + + + + + + + + + + + + + + + +| Erosion | 2 | Hyperplasia, Squamous | 3 2 1 2 3 1 3| Infiltration Cellular, Lymphocyte | 2 | Inflammation, Acute | 1 3 | Inflammation, Chronic Active | 2| Mineralization | 1 1 3 | Ulcer | | _____________________________________________________________________________________________________________________| Page 60 NTP Experiment-Test: 05007-05 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 08:05:11 _____________________________________________________________________________________________________________________ | 7| 7| 7| 7| 7| 7| 7| 7| 5| 6| 7| 7| 5| 7| 7| 4| 4| 4| 4| 4| 7| 7| 7| 7| 7| DAY ON TEST | 3| 3| 3| 3| 3| 3| 3| 1| 7| 3| 3| 3| 6| 3| 3| 5| 5| 5| 5| 5| 3| 3| 3| 3| 3| | 0| 0| 0| 0| 0| 1| 1| 5| 0| 7| 1| 1| 1| 1| 1| 7| 7| 7| 7| 7| 1| 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| 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| 5.0% | 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| _____________________________________________________________________________________________________________________| ALIMENTARY SYSTEM - cont | | | | __________________________________________________________________________| Stomach, Glandular | + + + + + + + + + + + + + + + + + + + +| Erosion | 2 | Infiltration Cellular, Lymphocyte | 2 2 2 2 2 2 2 2 2 1 | Inflammation, Acute | 1 | Inflammation, Chronic Active | | Mineralization | 1 2 2 3 3 | Mucosa, Ectasia | 2 2 | Mucosa, Inflammation, Acute | | Mucosa, Ulcer | | __________________________________________________________________________| Tooth | | Pulp, Inflammation, Chronic | | _____________________________________________________________________________________________________________________| CARDIOVASCULAR SYSTEM | | | | __________________________________________________________________________| Heart | + + + + + + + + + + + + + + + + + + + +| Infiltration Cellular, Lymphocyte | 1 2 | Inflammation, Acute | 2 | Inflammation, Chronic | 2 | _____________________________________________________________________________________________________________________| ENDOCRINE SYSTEM | | | | __________________________________________________________________________| Adrenal Gland | + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Adrenal Gland, Cortex | + + + + + + + + + + + + + + + + + + + +| Hyperplasia | | Hypertrophy | 2 2 2 2 2 | Spindle Cell, Hyperplasia, Lymphoid | 2 | Spindle Cell, Hyperplasia | 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 3| __________________________________________________________________________| Adrenal Gland, Medulla | + + + + + + + + + + + + + + + + + + + +| Hyperplasia | 2 | __________________________________________________________________________| Islets, Pancreatic | + + + + + + + + + + + + + + + + + + + +| Infiltration Cellular, Lymphocyte | 2 | __________________________________________________________________________| Parathyroid Gland | + + M + + M M M M M M M M M M + + + + +| __________________________________________________________________________| Pituitary Gland | + + + + + + + + + + + + + + + + + + + M| Pars Distalis, Cyst | X X | Pars Distalis, Hyperplasia | 2 | Pars Intermedia, Cyst | | __________________________________________________________________________| Thyroid Gland | + + + + + + + + + + + + + + + + + + + +| Infiltration Cellular, Lymphocyte | 2 | C-Cell, Hyperplasia | | Follicle, Ectasia | 2 | Follicle, Hyperplasia | | _____________________________________________________________________________________________________________________| GENERAL BODY SYSTEM | | | | None | | _____________________________________________________________________________________________________________________| GENITAL SYSTEM | | | | _____________________________________________________________________________________________________________________| Page 61 NTP Experiment-Test: 05007-05 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 08:05:11 _____________________________________________________________________________________________________________________ | 7| 7| 7| 7| 7| 7| 7| 7| 5| 6| 7| 7| 5| 7| 7| 4| 4| 4| 4| 4| 7| 7| 7| 7| 7| DAY ON TEST | 3| 3| 3| 3| 3| 3| 3| 1| 7| 3| 3| 3| 6| 3| 3| 5| 5| 5| 5| 5| 3| 3| 3| 3| 3| | 0| 0| 0| 0| 0| 1| 1| 5| 0| 7| 1| 1| 1| 1| 1| 7| 7| 7| 7| 7| 1| 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| 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| 5.0% | 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| _____________________________________________________________________________________________________________________| GENITAL SYSTEM - cont | | | | __________________________________________________________________________| Epididymis | + + + + + + + + + + + + + + + + + + + +| Infiltration Cellular, Lymphocyte | 1 2 2 2 2 2 2 2 2 2 2 2 2 | Serosa, Inflammation, Chronic Active | | __________________________________________________________________________| Penis | | Inflammation, Acute | | __________________________________________________________________________| Preputial Gland | + + +| Abscess | | Infiltration Cellular, Lymphocyte | 3| Inflammation, Chronic | 3 2 | Inflammation, Chronic Active | | Duct, Cyst | X | Duct, Ectasia | 2 | __________________________________________________________________________| Prostate | + + + + + + + + + + + + + + + + + + + +| Inflammation, Acute | | __________________________________________________________________________| Seminal Vesicle | + + + + + + + + + + + + + + + + + + + +| Ectasia | 4 | Infiltration Cellular, Lymphocyte | 2 1| Inflammation, Chronic | 3 | Serosa, Inflammation, Chronic Active | | __________________________________________________________________________| Testes | + + + + + + + + + + + + + + + + + + + +| Atrophy | 2 | Granuloma Sperm | | Mineralization | | Spermatogenic Arrest | X | Interstitial Cell, Hyperplasia | 2 2 2 2 | _____________________________________________________________________________________________________________________| HEMATOPOIETIC SYSTEM | | | | __________________________________________________________________________| Bone Marrow | + + + + + + + + + + + + + + + + + + + +| Angiectasis | | Hyperplasia, Reticulum Cell | | Myeloid Cell, Hyperplasia | 2 2 2 2 2 2 2 2 2 2 2 2 2| __________________________________________________________________________| Lymph Node | + + + + + + + + + + + + + + + + + + + +| Iliac, Hyperplasia, Lymphoid | | Mediastinal, Hyperplasia, Lymphoid | | Renal, Hyperplasia, Lymphoid | | __________________________________________________________________________| Lymph Node, Mandibular | + + + + + + + + + + + + + + + + + + + +| Hyperplasia, Lymphoid | 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2| Hyperplasia | 2 | Pigmentation | 2 2 1 | __________________________________________________________________________| Lymph Node, Mesenteric | + + + + + + + + + + + + + + M + + M + +| Angiectasis | | Congestion | 2 2 2 3 2 3 | Hyperplasia, Lymphoid | 2 2 2 2 3 1 2 2 2 2 2 3 2 2 2 3| Inflammation, Acute | 2 | _____________________________________________________________________________________________________________________| Page 62 NTP Experiment-Test: 05007-05 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 08:05:11 _____________________________________________________________________________________________________________________ | 7| 7| 7| 7| 7| 7| 7| 7| 5| 6| 7| 7| 5| 7| 7| 4| 4| 4| 4| 4| 7| 7| 7| 7| 7| DAY ON TEST | 3| 3| 3| 3| 3| 3| 3| 1| 7| 3| 3| 3| 6| 3| 3| 5| 5| 5| 5| 5| 3| 3| 3| 3| 3| | 0| 0| 0| 0| 0| 1| 1| 5| 0| 7| 1| 1| 1| 1| 1| 7| 7| 7| 7| 7| 1| 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| 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| 5.0% | 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| _____________________________________________________________________________________________________________________| HEMATOPOIETIC SYSTEM - cont | | | | __________________________________________________________________________| Spleen | + + + + + + + + + + + + + + + + + + + +| Atrophy | | Hematopoietic Cell Proliferation | 3 2 2 2 2 3 4 4 2 3 2 3 2 4 2 2| Hyperplasia, Glandular | | Hyperplasia, Lymphoid | 2 2 | Pigmentation | 1 2 | Capsule, Inflammation, Chronic Active| | __________________________________________________________________________| Thymus | + + + + + + M + + + + + + + + + + + + +| Cyst | X X X X | _____________________________________________________________________________________________________________________| INTEGUMENTARY SYSTEM | | | | __________________________________________________________________________| Mammary Gland | M M M M M M M M M M M M M M M M M M M M| __________________________________________________________________________| Skin | + + + + + + + + + + + + + + + + + + + +| Erosion | 2 | Fibrosis, Focal | | Inflammation, Chronic | 3 2 2 3 2 2 2 4 2| Inflammation, Chronic Active | 3 4 | Ulcer | 4 | Epithelium, Hyperplasia | 2 | Prepuce, Inflammation, Acute | | Prepuce, Ulcer | | Subcutaneous Tissue, Inflammation, | | Chronic Active | 4 | _____________________________________________________________________________________________________________________| MUSCULOSKELETAL SYSTEM | | | | __________________________________________________________________________| Bone | + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Skeletal Muscle | + | Abscess | | _____________________________________________________________________________________________________________________| NERVOUS SYSTEM | | | | __________________________________________________________________________| Brain | + + + + + + + + + + + + + + + + + + + +| Mineralization | 2 2 2 2 2 2 2 2 2 2 2 2| _____________________________________________________________________________________________________________________| RESPIRATORY SYSTEM | | | | __________________________________________________________________________| Lung | + + + + + + + + + + + + + + + + + + + +| Congestion | 2 | Hemorrhage | 1 2 | Infiltration Cellular, Lymphocyte | 2 2 2 2 1 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2| Alveolar Epithelium, Hyperplasia | 2 | Alveolus, Infiltration Cellular, | | Histiocyte | 2 | __________________________________________________________________________| Nose | + + + + + + + + + + + + + + + + + + + +| Lumen, Hemorrhage | 1 1 2 2 1 3 1 2 2 2 2 2 2| Mucosa, Inflammation, Acute | 1 | _____________________________________________________________________________________________________________________| Page 63 NTP Experiment-Test: 05007-05 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 08:05:11 _____________________________________________________________________________________________________________________ | 7| 7| 7| 7| 7| 7| 7| 7| 5| 6| 7| 7| 5| 7| 7| 4| 4| 4| 4| 4| 7| 7| 7| 7| 7| DAY ON TEST | 3| 3| 3| 3| 3| 3| 3| 1| 7| 3| 3| 3| 6| 3| 3| 5| 5| 5| 5| 5| 3| 3| 3| 3| 3| | 0| 0| 0| 0| 0| 1| 1| 5| 0| 7| 1| 1| 1| 1| 1| 7| 7| 7| 7| 7| 1| 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| 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| 5.0% | 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| _____________________________________________________________________________________________________________________| RESPIRATORY SYSTEM - cont | | | | Nasolacrimal Duct, Hemorrhage | 2 | Nasolacrimal Duct, Inflammation, | | Acute | 1 | Olfactory Epithelium, Degeneration | 2 2 2 2 1 1 1 2 2 2| __________________________________________________________________________| Trachea | + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| SPECIAL SENSES SYSTEM | | | | __________________________________________________________________________| Eye | + | Atrophy | | __________________________________________________________________________| Harderian Gland | + | _____________________________________________________________________________________________________________________| URINARY SYSTEM | | | | __________________________________________________________________________| Kidney | + + + + + + + + + + + + + + + + + + + +| Infiltration Cellular, Lymphocyte | 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2| Metaplasia, Osseous | 2 | Pelvis, Inflammation, Acute | | Renal Tubule, Casts Protein | 1 | Renal Tubule, Ectasia | 3 1 | Renal Tubule, Mineralization | 1 1 | Renal Tubule, Necrosis | 1 2 2 2 1 1 1 1 1 2 1| Renal Tubule, Regeneration | 2 2 1 2 1 1 1 1 2 2 2 1 2 2 2 2 2 2 | __________________________________________________________________________| Urethra | + + + + +| Calculus Micro Observation Only | X X X X X| Infiltration Cellular, Lymphocyte | | __________________________________________________________________________| Urinary Bladder | + + + + + + + + + + + + + + + + + + + +| Infiltration Cellular, Lymphocyte | 2 2 1 2 2 2 2 2 2 2 2 2 | Inflammation, Chronic | | _____________________________________________________________________________________________________________________| Page 64 NTP Experiment-Test: 05007-05 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 08:05:11 _____________________________________________________________________________________________________________________ | 7| 7| 7| 7| 7| 6| 6| 7| 7| 7| 6| 7| 7| 7| 7| 4| 4| 4| 4| 4| 6| 6| 7| 7| 7| DAY ON TEST | 3| 3| 3| 3| 3| 0| 7| 1| 3| 3| 1| 0| 3| 3| 3| 5| 5| 5| 5| 5| 0| 1| 3| 3| 3| | 1| 1| 1| 1| 1| 8| 2| 7| 1| 1| 3| 9| 1| 1| 4| 7| 7| 7| 7| 7| 4| 4| 4| 4| 4| _____________________________________________________________________________________________________________________| | 0| 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| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 5.0% | 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| _____________________________________________________________________________________________________________________| ALIMENTARY SYSTEM | | | | __________________________________________________________________________| Esophagus | + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Gallbladder | + + + + + M + + + + + + + + + + + + + +| Infiltration Cellular, Lymphocyte | 2 2 1 2 1| Epithelium, Degeneration | | __________________________________________________________________________| Intestine Large | + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Large, Cecum | + + + + + + + + + + + + + + + + + + + +| Serosa, Inflammation, Chronic Active | | __________________________________________________________________________| Intestine Large, Colon | + + M + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Large, Rectum | + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Small | + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Small, Duodenum | + + + + + + + + + + + + + + + + + + + +| Serosa, Inflammation, Chronic Active | | __________________________________________________________________________| Intestine Small, Ileum | + + + + + + + + + + + + + + + + M + + +| __________________________________________________________________________| Intestine Small, Jejunum | + + + + + + + + + + + + + + + + M + + +| Hyperplasia, Lymphoid | 3 | Serosa, Inflammation, Chronic Active | | __________________________________________________________________________| Liver | + + + + + + + + + + + + + + + + + + + +| Angiectasis | | Focal Cellular Change | X | Hematopoietic Cell Proliferation | 3 | Infarct | | Infiltration Cellular, Lymphocyte | 1 2 2 2 | Necrosis | 4 2 | Bile Duct, Cyst | | Hepatocyte, Hypertrophy | 2 | __________________________________________________________________________| Mesentery | + | Hemorrhage | | Inflammation, Chronic | 3 | Inflammation, Chronic Active | | __________________________________________________________________________| Pancreas | + + + + + + + + + + + + + + + + + + + +| Infiltration Cellular, Lymphocyte | 2 2 2 1 | Acinus, Atrophy | 4 | Duct, Cyst | X | __________________________________________________________________________| Salivary Glands | + + + + + + + + + + + + + + + + M + + +| Infiltration Cellular, Lymphocyte | 3 2 2 2 2 2 2 2 2 2 2 2 2 3 2 2| __________________________________________________________________________| Stomach | + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Stomach, Forestomach | + + + + + + + + + + + + + + + + + + + +| Erosion | | Hyperplasia, Squamous | 1 3 1 1 2 2 2| Infiltration Cellular, Lymphocyte | 1 2 2 2 | Inflammation, Acute | 2| Inflammation, Chronic Active | 2 3 2 2 | Mineralization | 1 1| Ulcer | 2 | _____________________________________________________________________________________________________________________| Page 65 NTP Experiment-Test: 05007-05 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 08:05:11 _____________________________________________________________________________________________________________________ | 7| 7| 7| 7| 7| 6| 6| 7| 7| 7| 6| 7| 7| 7| 7| 4| 4| 4| 4| 4| 6| 6| 7| 7| 7| DAY ON TEST | 3| 3| 3| 3| 3| 0| 7| 1| 3| 3| 1| 0| 3| 3| 3| 5| 5| 5| 5| 5| 0| 1| 3| 3| 3| | 1| 1| 1| 1| 1| 8| 2| 7| 1| 1| 3| 9| 1| 1| 4| 7| 7| 7| 7| 7| 4| 4| 4| 4| 4| _____________________________________________________________________________________________________________________| | 0| 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| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 5.0% | 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| _____________________________________________________________________________________________________________________| ALIMENTARY SYSTEM - cont | | | | __________________________________________________________________________| Stomach, Glandular | + + + + + + + + + + + + + + + + + + + +| Erosion | | Infiltration Cellular, Lymphocyte | 2 2 2 1 2 2 2 2 2 | Inflammation, Acute | 2 | Inflammation, Chronic Active | | Mineralization | 2| Mucosa, Ectasia | 2 | Mucosa, Inflammation, Acute | 2 | Mucosa, Ulcer | 2 | __________________________________________________________________________| Tooth | | Pulp, Inflammation, Chronic | | _____________________________________________________________________________________________________________________| CARDIOVASCULAR SYSTEM | | | | __________________________________________________________________________| Heart | + + + + + + + + + + + + + + + + + + + +| Infiltration Cellular, Lymphocyte | 2 2 2 | Inflammation, Acute | | Inflammation, Chronic | | _____________________________________________________________________________________________________________________| ENDOCRINE SYSTEM | | | | __________________________________________________________________________| Adrenal Gland | + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Adrenal Gland, Cortex | + + + + + + + + + + + + + + + + + + + +| Hyperplasia | | Hypertrophy | 2 1 2| Spindle Cell, Hyperplasia, Lymphoid | | Spindle Cell, Hyperplasia | 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2| __________________________________________________________________________| Adrenal Gland, Medulla | + + + + + + + + + + + + + + + + + + + +| Hyperplasia | 2 | __________________________________________________________________________| Islets, Pancreatic | + + + + + + + + + + + + + + + + + + + +| Infiltration Cellular, Lymphocyte | | __________________________________________________________________________| Parathyroid Gland | M M M + M M M M M + M M M M M M M + M M| __________________________________________________________________________| Pituitary Gland | + + + + + + + + + + + + + + + + + + + +| Pars Distalis, Cyst | X | Pars Distalis, Hyperplasia | 2 2 1| Pars Intermedia, Cyst | X | __________________________________________________________________________| Thyroid Gland | + + + + + + + + + + + + + + + + M + + +| Infiltration Cellular, Lymphocyte | 2 2 2 | C-Cell, Hyperplasia | 2 | Follicle, Ectasia | | Follicle, Hyperplasia | 2 | _____________________________________________________________________________________________________________________| GENERAL BODY SYSTEM | | | | None | | _____________________________________________________________________________________________________________________| GENITAL SYSTEM | | | | _____________________________________________________________________________________________________________________| Page 66 NTP Experiment-Test: 05007-05 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 08:05:11 _____________________________________________________________________________________________________________________ | 7| 7| 7| 7| 7| 6| 6| 7| 7| 7| 6| 7| 7| 7| 7| 4| 4| 4| 4| 4| 6| 6| 7| 7| 7| DAY ON TEST | 3| 3| 3| 3| 3| 0| 7| 1| 3| 3| 1| 0| 3| 3| 3| 5| 5| 5| 5| 5| 0| 1| 3| 3| 3| | 1| 1| 1| 1| 1| 8| 2| 7| 1| 1| 3| 9| 1| 1| 4| 7| 7| 7| 7| 7| 4| 4| 4| 4| 4| _____________________________________________________________________________________________________________________| | 0| 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| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 5.0% | 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| _____________________________________________________________________________________________________________________| GENITAL SYSTEM - cont | | | | __________________________________________________________________________| Epididymis | + + + + + + + + + + + + + + + + + + + +| Infiltration Cellular, Lymphocyte | 1 2 2 2 2 1 1 2 | Serosa, Inflammation, Chronic Active | | __________________________________________________________________________| Penis | | Inflammation, Acute | | __________________________________________________________________________| Preputial Gland | + + + + + + + | Abscess | 4 | Infiltration Cellular, Lymphocyte | | Inflammation, Chronic | 2 2 | Inflammation, Chronic Active | 3 4 3 3 | Duct, Cyst | | Duct, Ectasia | | __________________________________________________________________________| Prostate | + + + + + + + + + + + + + + + + + + + +| Inflammation, Acute | | __________________________________________________________________________| Seminal Vesicle | + + + + + + + + + + + + + + + + + + + +| Ectasia | | Infiltration Cellular, Lymphocyte | 2 2 | Inflammation, Chronic | 2 | Serosa, Inflammation, Chronic Active | | __________________________________________________________________________| Testes | + + + + + + + + + + + + + + + + + + + +| Atrophy | 2 | Granuloma Sperm | 3 | Mineralization | 2 3 | Spermatogenic Arrest | | Interstitial Cell, Hyperplasia | 2 2 2 | _____________________________________________________________________________________________________________________| HEMATOPOIETIC SYSTEM | | | | __________________________________________________________________________| Bone Marrow | + + + + + + + + + + + + + + + + + + + +| Angiectasis | | Hyperplasia, Reticulum Cell | 3 | Myeloid Cell, Hyperplasia | 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2| __________________________________________________________________________| Lymph Node | + + + + + + + + + + + + + + + + + + + +| Iliac, Hyperplasia, Lymphoid | | Mediastinal, Hyperplasia, Lymphoid | 2 | Renal, Hyperplasia, Lymphoid | | __________________________________________________________________________| Lymph Node, Mandibular | + + + + + + + + + + + + + + + + M + + +| Hyperplasia, Lymphoid | 2 2 2 2 2 2 2 2 2 2 2 2 2 2 | Hyperplasia | | Pigmentation | 2 2 2| __________________________________________________________________________| Lymph Node, Mesenteric | + + + + + A + + + + + + + + + + + + + +| Angiectasis | 3 3 3 | Congestion | 2 3 3 | Hyperplasia, Lymphoid | 4 2 2 3 2 2 2 3 2 3 2 3 2 2| Inflammation, Acute | | _____________________________________________________________________________________________________________________| Page 67 NTP Experiment-Test: 05007-05 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 08:05:11 _____________________________________________________________________________________________________________________ | 7| 7| 7| 7| 7| 6| 6| 7| 7| 7| 6| 7| 7| 7| 7| 4| 4| 4| 4| 4| 6| 6| 7| 7| 7| DAY ON TEST | 3| 3| 3| 3| 3| 0| 7| 1| 3| 3| 1| 0| 3| 3| 3| 5| 5| 5| 5| 5| 0| 1| 3| 3| 3| | 1| 1| 1| 1| 1| 8| 2| 7| 1| 1| 3| 9| 1| 1| 4| 7| 7| 7| 7| 7| 4| 4| 4| 4| 4| _____________________________________________________________________________________________________________________| | 0| 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| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 5.0% | 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| _____________________________________________________________________________________________________________________| HEMATOPOIETIC SYSTEM - cont | | | | __________________________________________________________________________| Spleen | + + + + + + + + + + + + + + + + + + + +| Atrophy | | Hematopoietic Cell Proliferation | 2 2 2 2 2 3 4 3 2 2 4 2 2 2 2| Hyperplasia, Glandular | | Hyperplasia, Lymphoid | 2 2 3 2 2 3 2| Pigmentation | 1 2 1 2 2 1| Capsule, Inflammation, Chronic Active| | __________________________________________________________________________| Thymus | + + + + + + + + + + + + + + + + + + + +| Cyst | X | _____________________________________________________________________________________________________________________| INTEGUMENTARY SYSTEM | | | | __________________________________________________________________________| Mammary Gland | M M M M M M M M M M M + M M + M M M M M| __________________________________________________________________________| Skin | + + + + + + + + + + + + + + + + + + + +| Erosion | | Fibrosis, Focal | 2 | Inflammation, Chronic | 4 4 3 3 3 2 2 3 3 2| Inflammation, Chronic Active | 3 | Ulcer | 3 3 | Epithelium, Hyperplasia | | Prepuce, Inflammation, Acute | | Prepuce, Ulcer | | Subcutaneous Tissue, Inflammation, | | Chronic Active | | _____________________________________________________________________________________________________________________| MUSCULOSKELETAL SYSTEM | | | | __________________________________________________________________________| Bone | + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Skeletal Muscle | + | Abscess | 4 | _____________________________________________________________________________________________________________________| NERVOUS SYSTEM | | | | __________________________________________________________________________| Brain | + + + + + + + + + + + + + + + + + + + +| Mineralization | 2 1 2 2 2 2 2 2 2 2 2 2 | _____________________________________________________________________________________________________________________| RESPIRATORY SYSTEM | | | | __________________________________________________________________________| Lung | + + + + + + + + + + + + + + + + + + + +| Congestion | 3 3 2| Hemorrhage | 2 | Infiltration Cellular, Lymphocyte | 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2| Alveolar Epithelium, Hyperplasia | 2 | Alveolus, Infiltration Cellular, | | Histiocyte | 2 | __________________________________________________________________________| Nose | + + + + + + + + + + + + + + + + M + + +| Lumen, Hemorrhage | 2 1 2 3 3 3 2 2 1 1| Mucosa, Inflammation, Acute | | _____________________________________________________________________________________________________________________| Page 68 NTP Experiment-Test: 05007-05 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 08:05:11 _____________________________________________________________________________________________________________________ | 7| 7| 7| 7| 7| 6| 6| 7| 7| 7| 6| 7| 7| 7| 7| 4| 4| 4| 4| 4| 6| 6| 7| 7| 7| DAY ON TEST | 3| 3| 3| 3| 3| 0| 7| 1| 3| 3| 1| 0| 3| 3| 3| 5| 5| 5| 5| 5| 0| 1| 3| 3| 3| | 1| 1| 1| 1| 1| 8| 2| 7| 1| 1| 3| 9| 1| 1| 4| 7| 7| 7| 7| 7| 4| 4| 4| 4| 4| _____________________________________________________________________________________________________________________| | 0| 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| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 5.0% | 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| _____________________________________________________________________________________________________________________| RESPIRATORY SYSTEM - cont | | | | Nasolacrimal Duct, Hemorrhage | | Nasolacrimal Duct, Inflammation, | | Acute | | Olfactory Epithelium, Degeneration | 2 2 2 2 2 2 2 1| __________________________________________________________________________| Trachea | + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| SPECIAL SENSES SYSTEM | | | | __________________________________________________________________________| Eye | + | Atrophy | 3 | __________________________________________________________________________| Harderian Gland | | _____________________________________________________________________________________________________________________| URINARY SYSTEM | | | | __________________________________________________________________________| Kidney | + + + + + + + + + + + + + + + + + + + +| Infiltration Cellular, Lymphocyte | 2 2 2 2 2 2 2 2 2 1 2 2 2 2 2 1 2 2 2| Metaplasia, Osseous | | Pelvis, Inflammation, Acute | | Renal Tubule, Casts Protein | 2 2 | Renal Tubule, Ectasia | 3 2 | Renal Tubule, Mineralization | 1 | Renal Tubule, Necrosis | 1 3 1 2 1 1 1 2 | Renal Tubule, Regeneration | 1 1 1 3 2 2 2 2 1 2 1 1 2 2| __________________________________________________________________________| Urethra | + + + + + + | Calculus Micro Observation Only | X X X X X | Infiltration Cellular, Lymphocyte | 2 | __________________________________________________________________________| Urinary Bladder | + + + + + + + + + + + + + + + + + + + +| Infiltration Cellular, Lymphocyte | 2 2 2 2 2 2 1 2 2 1 2| Inflammation, Chronic | | _____________________________________________________________________________________________________________________| Page 69 NTP Experiment-Test: 05007-05 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 08:05:11 __________________________________________________________________________________________________________________________________ | 2| 6| 6| 7| 7| 1| 1| 1| 7| 7| | | DAY ON TEST | 8| 4| 4| 0| 3| 4| 5| 7| 3| 3| | | | 0| 5| 4| 8| 4| 7| 0| 0| 4| 4| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | B6C3F1 MICE MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| | A | 5.0% | 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| | L | | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| | | __________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM | | | | | | __________________________________________________________________________|____________| Esophagus | M + + + + + + + + + | 49 | __________________________________________________________________________|____________| Gallbladder | + + + + + + + + + + | 49 | Infiltration Cellular, Lymphocyte | 2 1 2 | 18 1.8| Epithelium, Degeneration | | 1 2.0| __________________________________________________________________________|____________| Intestine Large | + + + + + + + + + + | 50 | __________________________________________________________________________|____________| Intestine Large, Cecum | + + + + + + + + + + | 50 | Serosa, Inflammation, Chronic Active | 3 | 1 3.0| __________________________________________________________________________|____________| Intestine Large, Colon | + + + + + + + + + + | 49 | __________________________________________________________________________|____________| Intestine Large, Rectum | + + + + + M + M + + | 48 | __________________________________________________________________________|____________| Intestine Small | + + + + + + + + + + | 50 | __________________________________________________________________________|____________| Intestine Small, Duodenum | + + + + + + M + + + | 49 | Serosa, Inflammation, Chronic Active | 3 | 1 3.0| __________________________________________________________________________|____________| Intestine Small, Ileum | + + + + + + M + + + | 48 | __________________________________________________________________________|____________| Intestine Small, Jejunum | + + + + + + + + + + | 49 | Hyperplasia, Lymphoid | | 1 3.0| Serosa, Inflammation, Chronic Active | 3 | 1 3.0| __________________________________________________________________________|____________| Liver | + + + + + + + + + + | 50 | Angiectasis | 3 | 1 3.0| Focal Cellular Change | | 2 | Hematopoietic Cell Proliferation | 1 1 | 7 1.6| Infarct | | 1 4.0| Infiltration Cellular, Lymphocyte | 2 | 7 1.9| Necrosis | | 4 2.3| Bile Duct, Cyst | | 1 | Hepatocyte, Hypertrophy | | 1 2.0| __________________________________________________________________________|____________| Mesentery | + + | 3 | Hemorrhage | 3 | 1 3.0| Inflammation, Chronic | | 1 3.0| Inflammation, Chronic Active | 4 | 1 4.0| __________________________________________________________________________|____________| Pancreas | + + + + + + + + + + | 50 | Infiltration Cellular, Lymphocyte | 2 | 10 1.8| Acinus, Atrophy | | 1 4.0| Duct, Cyst | | 2 | __________________________________________________________________________|____________| Salivary Glands | + + + + + + + + + + | 49 | Infiltration Cellular, Lymphocyte | 2 2 2 2 1 2 | 42 2.0| __________________________________________________________________________|____________| Stomach | + + + + + + + + + + | 50 | __________________________________________________________________________|____________| Stomach, Forestomach | + + + + + + + + + + | 50 | Erosion | | 1 2.0| Hyperplasia, Squamous | 3 2 2 2 3 | 19 2.1| __________________________________________________________________________________________________________________________________ * : 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 70 NTP Experiment-Test: 05007-05 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 08:05:11 __________________________________________________________________________________________________________________________________ | 2| 6| 6| 7| 7| 1| 1| 1| 7| 7| | | DAY ON TEST | 8| 4| 4| 0| 3| 4| 5| 7| 3| 3| | | | 0| 5| 4| 8| 4| 7| 0| 0| 4| 4| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | B6C3F1 MICE MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| | A | 5.0% | 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| | L | | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| | | __________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - cont | | | | | | Infiltration Cellular, Lymphocyte | 2 | 6 1.8| Inflammation, Acute | 1 2 | 5 1.8| Inflammation, Chronic Active | 3 2 | 7 2.3| Mineralization | 1 | 6 1.3| Ulcer | | 1 2.0| __________________________________________________________________________|____________| Stomach, Glandular | + + + + + + + + + + | 50 | Erosion | | 1 2.0| Infiltration Cellular, Lymphocyte | 2 2 2 | 22 1.9| Inflammation, Acute | | 2 1.5| Inflammation, Chronic Active | 2 | 1 2.0| Mineralization | 2 1 2 | 9 2.0| Mucosa, Ectasia | | 3 2.0| Mucosa, Inflammation, Acute | | 1 2.0| Mucosa, Ulcer | | 1 2.0| __________________________________________________________________________|____________| Tooth | + | 1 | Pulp, Inflammation, Chronic | 4 | 1 4.0| _____________________________________________________________________________________________________________________| | CARDIOVASCULAR SYSTEM | | | | | | __________________________________________________________________________|____________| Heart | + + + + + + + + + + | 50 | Infiltration Cellular, Lymphocyte | 2 2 | 7 1.9| Inflammation, Acute | | 1 2.0| Inflammation, Chronic | | 1 2.0| _____________________________________________________________________________________________________________________| | ENDOCRINE SYSTEM | | | | | | __________________________________________________________________________|____________| Adrenal Gland | + + + + + + + + + + | 50 | __________________________________________________________________________|____________| Adrenal Gland, Cortex | + + + + + + + + + + | 50 | Hyperplasia | 2 | 1 2.0| Hypertrophy | 1 2 2 | 11 1.8| Spindle Cell, Hyperplasia, Lymphoid | | 1 2.0| Spindle Cell, Hyperplasia | 2 2 2 2 2 2 1 2 2 | 46 2.0| __________________________________________________________________________|____________| Adrenal Gland, Medulla | + + + + + + + + + + | 50 | Hyperplasia | | 2 2.0| __________________________________________________________________________|____________| Islets, Pancreatic | + + + + + + + + + + | 50 | Infiltration Cellular, Lymphocyte | | 1 2.0| __________________________________________________________________________|____________| Parathyroid Gland | + + + M + M + + + M | 19 | __________________________________________________________________________|____________| Pituitary Gland | + + + + + + + + + + | 49 | Pars Distalis, Cyst | | 3 | Pars Distalis, Hyperplasia | | 4 1.8| Pars Intermedia, Cyst | | 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 71 NTP Experiment-Test: 05007-05 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 08:05:11 __________________________________________________________________________________________________________________________________ | 2| 6| 6| 7| 7| 1| 1| 1| 7| 7| | | DAY ON TEST | 8| 4| 4| 0| 3| 4| 5| 7| 3| 3| | | | 0| 5| 4| 8| 4| 7| 0| 0| 4| 4| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | B6C3F1 MICE MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| | A | 5.0% | 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| | L | | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| | | __________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM - cont | | | | | | __________________________________________________________________________|____________| Thyroid Gland | + + + + + + + + + + | 49 | Infiltration Cellular, Lymphocyte | | 4 2.0| C-Cell, Hyperplasia | | 1 2.0| Follicle, Ectasia | | 1 2.0| Follicle, Hyperplasia | 1 | 2 1.5| _____________________________________________________________________________________________________________________| | GENERAL BODY SYSTEM | | | | | | None | | | _____________________________________________________________________________________________________________________| | GENITAL SYSTEM | | | | | | __________________________________________________________________________|____________| Epididymis | + + + + + + + + + + | 50 | Infiltration Cellular, Lymphocyte | 2 1 2 2 | 25 1.8| Serosa, Inflammation, Chronic Active | 3 | 1 3.0| __________________________________________________________________________|____________| Penis | + + + | 3 | Inflammation, Acute | 4 2 | 2 3.0| __________________________________________________________________________|____________| Preputial Gland | + | 11 | Abscess | | 1 4.0| Infiltration Cellular, Lymphocyte | | 1 3.0| Inflammation, Chronic | | 4 2.3| Inflammation, Chronic Active | 3 | 5 3.2| Duct, Cyst | | 1 | Duct, Ectasia | | 1 2.0| __________________________________________________________________________|____________| Prostate | + + + + + + + + + + | 50 | Inflammation, Acute | 3 | 1 3.0| __________________________________________________________________________|____________| Seminal Vesicle | M + + + + + + + + + | 49 | Ectasia | | 1 4.0| Infiltration Cellular, Lymphocyte | | 4 1.8| Inflammation, Chronic | 3 | 3 2.7| Serosa, Inflammation, Chronic Active | 3 | 1 3.0| __________________________________________________________________________|____________| Testes | + + + + + + + + + + | 50 | Atrophy | | 2 2.0| Granuloma Sperm | | 1 3.0| Mineralization | | 2 2.5| Spermatogenic Arrest | | 1 | Interstitial Cell, Hyperplasia | 2 2 | 9 2.0| _____________________________________________________________________________________________________________________| | HEMATOPOIETIC SYSTEM | | | | | | __________________________________________________________________________|____________| Bone Marrow | + + + + + + + + + + | 50 | Angiectasis | 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 72 NTP Experiment-Test: 05007-05 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 08:05:11 __________________________________________________________________________________________________________________________________ | 2| 6| 6| 7| 7| 1| 1| 1| 7| 7| | | DAY ON TEST | 8| 4| 4| 0| 3| 4| 5| 7| 3| 3| | | | 0| 5| 4| 8| 4| 7| 0| 0| 4| 4| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | B6C3F1 MICE MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| | A | 5.0% | 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| | L | | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| | | __________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - cont | | | | | | Hyperplasia, Reticulum Cell | | 1 3.0| Myeloid Cell, Hyperplasia | 2 2 2 2 2 2 | 36 2.0| __________________________________________________________________________|____________| Lymph Node | + + + + + + + + + + | 50 | Iliac, Hyperplasia, Lymphoid | 3 | 1 3.0| Mediastinal, Hyperplasia, Lymphoid | | 1 2.0| Renal, Hyperplasia, Lymphoid | 3 | 1 3.0| __________________________________________________________________________|____________| Lymph Node, Mandibular | + + + + + + + + + + | 49 | Hyperplasia, Lymphoid | 2 2 2 2 | 37 2.0| Hyperplasia | | 1 2.0| Pigmentation | 2 1 2 | 9 1.8| __________________________________________________________________________|____________| Lymph Node, Mesenteric | M + + + + + + + + + | 46 | Angiectasis | | 3 3.0| Congestion | 3 | 10 2.5| Hyperplasia, Lymphoid | 2 2 2 3 3 | 35 2.3| Inflammation, Acute | 3 2 | 3 2.3| __________________________________________________________________________|____________| Spleen | + + + + + + + + M + | 49 | Atrophy | 3 2 | 2 2.5| Hematopoietic Cell Proliferation | 2 4 3 2 | 35 2.5| Hyperplasia, Glandular | 2 | 1 2.0| Hyperplasia, Lymphoid | 2 | 10 2.2| Pigmentation | 2 | 9 1.6| Capsule, Inflammation, Chronic Active| 3 | 1 3.0| __________________________________________________________________________|____________| Thymus | + + + + + + + + + + | 49 | Cyst | X X X X | 9 | _____________________________________________________________________________________________________________________| | INTEGUMENTARY SYSTEM | | | | | | __________________________________________________________________________|____________| Mammary Gland | M M M M M M M M M + | 3 | __________________________________________________________________________|____________| Skin | + + + + + + + + + + | 50 | Erosion | | 1 2.0| Fibrosis, Focal | | 1 2.0| Inflammation, Chronic | 3 2 2 2 1 | 24 2.5| Inflammation, Chronic Active | | 3 3.3| Ulcer | 4 4 | 5 3.6| Epithelium, Hyperplasia | | 1 2.0| Prepuce, Inflammation, Acute | 2 | 1 2.0| Prepuce, Ulcer | 4 | 1 4.0| Subcutaneous Tissue, Inflammation, | | | Chronic Active | | 1 4.0| _____________________________________________________________________________________________________________________| | 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 73 NTP Experiment-Test: 05007-05 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 08:05:11 __________________________________________________________________________________________________________________________________ | 2| 6| 6| 7| 7| 1| 1| 1| 7| 7| | | DAY ON TEST | 8| 4| 4| 0| 3| 4| 5| 7| 3| 3| | | | 0| 5| 4| 8| 4| 7| 0| 0| 4| 4| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | B6C3F1 MICE MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| | A | 5.0% | 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| | L | | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| | | __________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM - cont | | | | | | | | | __________________________________________________________________________|____________| Bone | + + + + + + + + + + | 50 | __________________________________________________________________________|____________| Skeletal Muscle | | 2 | Abscess | | 1 4.0| _____________________________________________________________________________________________________________________| | NERVOUS SYSTEM | | | | | | __________________________________________________________________________|____________| Brain | + + + + + + + + + + | 50 | Mineralization | 2 1 2 2 1 | 29 1.9| _____________________________________________________________________________________________________________________| | RESPIRATORY SYSTEM | | | | | | __________________________________________________________________________|____________| Lung | + + + + + + + + + + | 50 | Congestion | | 4 2.5| Hemorrhage | 2 | 4 1.8| Infiltration Cellular, Lymphocyte | 2 2 2 2 2 2 2 | 43 2.0| Alveolar Epithelium, Hyperplasia | | 2 2.0| Alveolus, Infiltration Cellular, | | | Histiocyte | | 2 2.0| __________________________________________________________________________|____________| Nose | + + + + + + + + + + | 49 | Lumen, Hemorrhage | 2 2 1 2 2 2 | 29 1.9| Mucosa, Inflammation, Acute | 2 2 | 3 1.7| Nasolacrimal Duct, Hemorrhage | | 1 2.0| Nasolacrimal Duct, Inflammation, | | | Acute | | 1 1.0| Olfactory Epithelium, Degeneration | 2 2 2 1 2 | 23 1.8| __________________________________________________________________________|____________| Trachea | + + + + + + + + + + | 50 | _____________________________________________________________________________________________________________________| | SPECIAL SENSES SYSTEM | | | | | | __________________________________________________________________________|____________| Eye | | 2 | Atrophy | | 1 3.0| __________________________________________________________________________|____________| Harderian Gland | | 1 | _____________________________________________________________________________________________________________________| | URINARY SYSTEM | | | | | | __________________________________________________________________________|____________| Kidney | + + + + + + + + + + | 50 | Infiltration Cellular, Lymphocyte | 2 1 2 2 2 2 2 | 46 1.9| Metaplasia, Osseous | | 1 2.0| Pelvis, Inflammation, Acute | 3 2 | 2 2.5| Renal Tubule, Casts Protein | 2 | 4 1.8| Renal Tubule, Ectasia | 2 2 2 | 7 2.1| Renal Tubule, Mineralization | 1 2 | 5 1.2| __________________________________________________________________________________________________________________________________ * : 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 74 NTP Experiment-Test: 05007-05 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 08:05:11 __________________________________________________________________________________________________________________________________ | 2| 6| 6| 7| 7| 1| 1| 1| 7| 7| | | DAY ON TEST | 8| 4| 4| 0| 3| 4| 5| 7| 3| 3| | | | 0| 5| 4| 8| 4| 7| 0| 0| 4| 4| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | B6C3F1 MICE MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| | A | 5.0% | 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| | L | | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| | | __________________________________________________________________________________________________________________________________ URINARY SYSTEM - cont | | | | | | Renal Tubule, Necrosis | 1 2 1 1 | 23 1.4| Renal Tubule, Regeneration | 2 1 2 2 | 36 1.7| __________________________________________________________________________|____________| Urethra | + + + + | 15 | Calculus Micro Observation Only | X X X X | 14 | Infiltration Cellular, Lymphocyte | | 1 2.0| __________________________________________________________________________|____________| Urinary Bladder | + + + + + + + + + + | 50 | Infiltration Cellular, Lymphocyte | 2 2 | 25 1.9| Inflammation, Chronic | 2 3 | 2 2.5| __________________________________________________________________________________________________________________________________ * : 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 75 NTP Experiment-Test: 05007-05 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 08:05:11 _____________________________________________________________________________________________________________________ | 5| 6| 7| 7| 7| 6| 6| 7| 7| 7| 4| 3| 4| 4| 4| 5| 6| 6| 7| 7| 5| 7| 7| 7| 7| DAY ON TEST | 4| 7| 3| 3| 3| 3| 4| 3| 3| 3| 5| 6| 5| 5| 5| 9| 5| 7| 0| 3| 3| 0| 3| 3| 3| | 1| 8| 4| 4| 4| 4| 6| 4| 4| 4| 1| 1| 7| 7| 7| 8| 1| 2| 5| 4| 3| 9| 4| 4| 4| _____________________________________________________________________________________________________________________| | 0| 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 | 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| 2.5% | 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| _____________________________________________________________________________________________________________________| ALIMENTARY SYSTEM | | | | __________________________________________________________________________| Esophagus | + + + + + + + + + + | __________________________________________________________________________| Gallbladder | + + + + + + + + M + | Ectasia | 3 | Infiltration Cellular, Lymphocyte | | __________________________________________________________________________| Intestine Large | + + + + + + + + + + | __________________________________________________________________________| Intestine Large, Cecum | + + + + + + + + + + | __________________________________________________________________________| Intestine Large, Colon | + + + + + + + + + + | __________________________________________________________________________| Intestine Large, Rectum | + + + + + + + + + + | __________________________________________________________________________| Intestine Small | + + + + + + + + + + | __________________________________________________________________________| Intestine Small, Duodenum | + + + + + + + + + + | __________________________________________________________________________| Intestine Small, Ileum | + + + + + + + + + + | __________________________________________________________________________| Intestine Small, Jejunum | + + + + + + + + + + | __________________________________________________________________________| Liver | + + + + + + + + + + + | Developmental Malformation | X | Focal Cellular Change | | Infiltration Cellular, Lymphocyte | 2 2 1 2 | Necrosis | 3 2 | Bile Duct, Cyst | | __________________________________________________________________________| Mesentery | + + + | Fat, Necrosis | 4 | __________________________________________________________________________| Pancreas | + + + + + + + + + + | Infiltration Cellular, Lymphocyte | 2 2 | Acinus, Atrophy | | Duct, Cyst | | __________________________________________________________________________| Salivary Glands | + + + + + + + + + + | Infiltration Cellular, Lymphocyte | 2 2 2 2 2 | __________________________________________________________________________| Stomach | + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Stomach, Forestomach | + + + + + + + + + + + + + + + + + + + +| Hyperkeratosis | | Hyperplasia, Squamous | | Inflammation, Acute | 2 | Inflammation, Chronic Active | | Mineralization | 1 1 | Glandular, Cyst Epithelial Inclusion | | __________________________________________________________________________| Stomach, Glandular | + + + + + + + + + + + + + + + + + + + +| Infiltration Cellular, Lymphocyte | 2 2 2 | Inflammation, Acute | 2 | Inflammation, Chronic Active | | Mineralization | 2 | Mucosa, Dilatation | | Mucosa, Ectasia | 2 | Mucosa, Mineralization | 3 | _____________________________________________________________________________________________________________________| CARDIOVASCULAR SYSTEM | | | | _____________________________________________________________________________________________________________________| Page 76 NTP Experiment-Test: 05007-05 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 08:05:11 _____________________________________________________________________________________________________________________ | 5| 6| 7| 7| 7| 6| 6| 7| 7| 7| 4| 3| 4| 4| 4| 5| 6| 6| 7| 7| 5| 7| 7| 7| 7| DAY ON TEST | 4| 7| 3| 3| 3| 3| 4| 3| 3| 3| 5| 6| 5| 5| 5| 9| 5| 7| 0| 3| 3| 0| 3| 3| 3| | 1| 8| 4| 4| 4| 4| 6| 4| 4| 4| 1| 1| 7| 7| 7| 8| 1| 2| 5| 4| 3| 9| 4| 4| 4| _____________________________________________________________________________________________________________________| | 0| 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 | 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| 2.5% | 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| _____________________________________________________________________________________________________________________| CARDIOVASCULAR SYSTEM - cont | | | | __________________________________________________________________________| Heart | + + + + + + + + + + | Mineralization | 3 | _____________________________________________________________________________________________________________________| ENDOCRINE SYSTEM | | | | __________________________________________________________________________| Adrenal Gland | + + + + + + + + + + | __________________________________________________________________________| Adrenal Gland, Cortex | + + + + + + + + + + | Spindle Cell, Hyperplasia, Lymphoid | 2 | Spindle Cell, Hyperplasia | 2 2 2 2 2 2 2 2 2 | __________________________________________________________________________| Adrenal Gland, Medulla | + + + + + + + + + + | Hyperplasia | 2 | __________________________________________________________________________| Islets, Pancreatic | + + + + + + + + + + | __________________________________________________________________________| Parathyroid Gland | M M M + + + + M + + | __________________________________________________________________________| Pituitary Gland | + + + + + + + + + + | __________________________________________________________________________| Thyroid Gland | + + + + + + + + + + | Infiltration Cellular, Lymphocyte | | Follicle, Ectasia | 2 | Follicle, Hyperplasia, Cystic | | _____________________________________________________________________________________________________________________| GENERAL BODY SYSTEM | | | | None | | _____________________________________________________________________________________________________________________| GENITAL SYSTEM | | | | __________________________________________________________________________| Epididymis | + + + + + + + + + + | Infiltration Cellular, Lymphocyte | 2 2 2 | __________________________________________________________________________| Preputial Gland | + M + +| Abscess | 4 | Infiltration Cellular, Lymphocyte | | Inflammation, Chronic | | Inflammation, Chronic Active | 2 4| Duct, Cyst | 2 | __________________________________________________________________________| Prostate | + + + + + + + + + + | __________________________________________________________________________| Seminal Vesicle | + + + + + + + + + + | __________________________________________________________________________| Testes | + + + + + + + + + + | Mineralization | 2 | Necrosis | | _____________________________________________________________________________________________________________________| HEMATOPOIETIC SYSTEM | | | | __________________________________________________________________________| Bone Marrow | + + + + + + + + + + | Myeloid Cell, Hyperplasia | 2 2 2 2 2 2 2 | __________________________________________________________________________| Lymph Node | + + + + + + + + + + + + + +| Inguinal, Hyperplasia, Lymphoid | 2 3 | Mediastinal, Congestion | 2 | Mediastinal, Hyperplasia, Lymphoid | 2 2 | __________________________________________________________________________| Lymph Node, Mandibular | + + + + + + + + M + | _____________________________________________________________________________________________________________________| Page 77 NTP Experiment-Test: 05007-05 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 08:05:11 _____________________________________________________________________________________________________________________ | 5| 6| 7| 7| 7| 6| 6| 7| 7| 7| 4| 3| 4| 4| 4| 5| 6| 6| 7| 7| 5| 7| 7| 7| 7| DAY ON TEST | 4| 7| 3| 3| 3| 3| 4| 3| 3| 3| 5| 6| 5| 5| 5| 9| 5| 7| 0| 3| 3| 0| 3| 3| 3| | 1| 8| 4| 4| 4| 4| 6| 4| 4| 4| 1| 1| 7| 7| 7| 8| 1| 2| 5| 4| 3| 9| 4| 4| 4| _____________________________________________________________________________________________________________________| | 0| 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 | 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| 2.5% | 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| _____________________________________________________________________________________________________________________| HEMATOPOIETIC SYSTEM - cont | | | | Hyperplasia, Lymphoid | 2 2 | Pigmentation | | __________________________________________________________________________| Lymph Node, Mesenteric | + + + + + + + + + + + + + +| Angiectasis | 3 | Congestion | 4 3 2 3 3 3| Hemorrhage | 4 4 | Hyperplasia, Lymphoid | 2 3 3 2 2 2 | Inflammation, Acute | | Inflammation, Chronic | 2 | __________________________________________________________________________| Spleen | + + + + + + + + + + | Hematopoietic Cell Proliferation | 2 3 2 3 2 2 2 | Hyperplasia, Lymphoid | 2 2 | Pigmentation | 2 | __________________________________________________________________________| Thymus | M + + + + + + + + + | Cyst | | Hyperplasia, Lymphoid | | _____________________________________________________________________________________________________________________| INTEGUMENTARY SYSTEM | | | | __________________________________________________________________________| Mammary Gland | M M M M M M M M M M | __________________________________________________________________________| Skin | + + + + + + + + + + + + + + + + | Alopecia | | Angiectasis | | Erosion | 2 | Hyperplasia | | Inflammation, Chronic | 2 3 2 3 3 3 | Inflammation, Chronic Active | | Ulcer | 4 3 | Prepuce, Inflammation, Chronic | | _____________________________________________________________________________________________________________________| MUSCULOSKELETAL SYSTEM | | | | __________________________________________________________________________| Bone | + + + + + + + + + + | __________________________________________________________________________| Skeletal Muscle | + | _____________________________________________________________________________________________________________________| NERVOUS SYSTEM | | | | __________________________________________________________________________| Brain | + + + + + + + + + + | Mineralization | 2 2 2 2 2 | _____________________________________________________________________________________________________________________| RESPIRATORY SYSTEM | | | | __________________________________________________________________________| Lung | + + + + + + + + + + + | Congestion | 2 | Hemorrhage | 2 | Infiltration Cellular, Lymphocyte | 2 2 2 2 2 1 | __________________________________________________________________________| Nose | + + + + + + + + + + | Lumen, Hemorrhage | 2 2 | _____________________________________________________________________________________________________________________| Page 78 NTP Experiment-Test: 05007-05 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 08:05:11 _____________________________________________________________________________________________________________________ | 5| 6| 7| 7| 7| 6| 6| 7| 7| 7| 4| 3| 4| 4| 4| 5| 6| 6| 7| 7| 5| 7| 7| 7| 7| DAY ON TEST | 4| 7| 3| 3| 3| 3| 4| 3| 3| 3| 5| 6| 5| 5| 5| 9| 5| 7| 0| 3| 3| 0| 3| 3| 3| | 1| 8| 4| 4| 4| 4| 6| 4| 4| 4| 1| 1| 7| 7| 7| 8| 1| 2| 5| 4| 3| 9| 4| 4| 4| _____________________________________________________________________________________________________________________| | 0| 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 | 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| 2.5% | 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| _____________________________________________________________________________________________________________________| RESPIRATORY SYSTEM - cont | | | | Nasolacrimal Duct, Inflammation, | | Acute | 2 2 2 | Olfactory Epithelium, Degeneration | 1 1 1 2 2 | __________________________________________________________________________| Trachea | + + + + + + + + + + | _____________________________________________________________________________________________________________________| SPECIAL SENSES SYSTEM | | | | __________________________________________________________________________| Eye | | __________________________________________________________________________| Harderian Gland | | _____________________________________________________________________________________________________________________| URINARY SYSTEM | | | | __________________________________________________________________________| Kidney | + + + + + + + + + + | Congestion | 3 | Hemorrhage | 3 | Infiltration Cellular, Lymphocyte | 1 2 1 2 2 2 2 2 | Inflammation, Chronic | 2 | Glomerulus, Renal Tubule, | | Mineralization | 4 | Renal Tubule, Ectasia | 2 | Renal Tubule, Mineralization | 2 | Renal Tubule, Necrosis | 2 | Renal Tubule, Regeneration | 2 1 | __________________________________________________________________________| Urethra | + + | Calculus Micro Observation Only | X X | __________________________________________________________________________| Urinary Bladder | + + + + + + + + + + | Ectasia | 2 | Infiltration Cellular, Lymphocyte | 2 2 | _____________________________________________________________________________________________________________________| Page 79 NTP Experiment-Test: 05007-05 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 08:05:11 _____________________________________________________________________________________________________________________ | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 5| 7| 7| 7| 7| 7| 7| 7| 7| 7| 5| 7| 7| 7| 7| DAY ON TEST | 0| 3| 3| 3| 3| 0| 3| 3| 3| 3| 8| 3| 3| 3| 3| 3| 3| 3| 3| 3| 9| 0| 0| 3| 3| | 6| 4| 4| 4| 4| 8| 4| 4| 4| 5| 1| 5| 5| 5| 5| 5| 5| 5| 5| 5| 6| 7| 8| 5| 5| _____________________________________________________________________________________________________________________| | 0| 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 | 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| 2.5% | 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| _____________________________________________________________________________________________________________________| ALIMENTARY SYSTEM | | | | __________________________________________________________________________| Esophagus | + M + + + + | __________________________________________________________________________| Gallbladder | + + + + + + | Ectasia | | Infiltration Cellular, Lymphocyte | 2 2 | __________________________________________________________________________| Intestine Large | + + + + + + | __________________________________________________________________________| Intestine Large, Cecum | + + + + + + | __________________________________________________________________________| Intestine Large, Colon | + + + + + + | __________________________________________________________________________| Intestine Large, Rectum | + + + + + + | __________________________________________________________________________| Intestine Small | + + + + + + | __________________________________________________________________________| Intestine Small, Duodenum | + + + + + + | __________________________________________________________________________| Intestine Small, Ileum | + + M + + + | __________________________________________________________________________| Intestine Small, Jejunum | + + + + + + | __________________________________________________________________________| Liver | + + + + + + + + + + + + | Developmental Malformation | | Focal Cellular Change | X | Infiltration Cellular, Lymphocyte | 1 | Necrosis | 4 | Bile Duct, Cyst | X | __________________________________________________________________________| Mesentery | + + | Fat, Necrosis | 4 3 | __________________________________________________________________________| Pancreas | + + + + + + | Infiltration Cellular, Lymphocyte | 2 | Acinus, Atrophy | 2 | Duct, Cyst | | __________________________________________________________________________| Salivary Glands | + + + + + + | Infiltration Cellular, Lymphocyte | 2 2 1 2 | __________________________________________________________________________| Stomach | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Stomach, Forestomach | + + + + + + + + + + + + + + + + + + + + + + + + +| Hyperkeratosis | 1 | Hyperplasia, Squamous | 2 2 2 1 | Inflammation, Acute | 2 2 | Inflammation, Chronic Active | 2 | Mineralization | | Glandular, Cyst Epithelial Inclusion | X | __________________________________________________________________________| Stomach, Glandular | + + + + + + + + + + + + + + + + + + + + + + + + +| Infiltration Cellular, Lymphocyte | 2 2 2 2 2 2 | Inflammation, Acute | 2 | Inflammation, Chronic Active | 4 | Mineralization | 2 | Mucosa, Dilatation | | Mucosa, Ectasia | | Mucosa, Mineralization | | _____________________________________________________________________________________________________________________| CARDIOVASCULAR SYSTEM | | | | _____________________________________________________________________________________________________________________| Page 80 NTP Experiment-Test: 05007-05 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 08:05:11 _____________________________________________________________________________________________________________________ | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 5| 7| 7| 7| 7| 7| 7| 7| 7| 7| 5| 7| 7| 7| 7| DAY ON TEST | 0| 3| 3| 3| 3| 0| 3| 3| 3| 3| 8| 3| 3| 3| 3| 3| 3| 3| 3| 3| 9| 0| 0| 3| 3| | 6| 4| 4| 4| 4| 8| 4| 4| 4| 5| 1| 5| 5| 5| 5| 5| 5| 5| 5| 5| 6| 7| 8| 5| 5| _____________________________________________________________________________________________________________________| | 0| 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 | 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| 2.5% | 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| _____________________________________________________________________________________________________________________| CARDIOVASCULAR SYSTEM - cont | | | | __________________________________________________________________________| Heart | + + + + + + | Mineralization | | _____________________________________________________________________________________________________________________| ENDOCRINE SYSTEM | | | | __________________________________________________________________________| Adrenal Gland | + + + + + + | __________________________________________________________________________| Adrenal Gland, Cortex | + + + + + + | Spindle Cell, Hyperplasia, Lymphoid | | Spindle Cell, Hyperplasia | 2 2 2 2 2 | __________________________________________________________________________| Adrenal Gland, Medulla | + + + + + + | Hyperplasia | | __________________________________________________________________________| Islets, Pancreatic | + + + + + + | __________________________________________________________________________| Parathyroid Gland | M M M M M + | __________________________________________________________________________| Pituitary Gland | M + + + + + | __________________________________________________________________________| Thyroid Gland | + M + + + + + | Infiltration Cellular, Lymphocyte | 2 | Follicle, Ectasia | | Follicle, Hyperplasia, Cystic | 3 | _____________________________________________________________________________________________________________________| GENERAL BODY SYSTEM | | | | None | | _____________________________________________________________________________________________________________________| GENITAL SYSTEM | | | | __________________________________________________________________________| Epididymis | + + + + + + | Infiltration Cellular, Lymphocyte | 2 | __________________________________________________________________________| Preputial Gland | + + + + + + + + + | Abscess | 3 4 4 4 | Infiltration Cellular, Lymphocyte | 2 3 2 | Inflammation, Chronic | | Inflammation, Chronic Active | 3 | Duct, Cyst | | __________________________________________________________________________| Prostate | + + + + + + + | __________________________________________________________________________| Seminal Vesicle | + + + + + + | __________________________________________________________________________| Testes | + + + + + + | Mineralization | 2 2 | Necrosis | | _____________________________________________________________________________________________________________________| HEMATOPOIETIC SYSTEM | | | | __________________________________________________________________________| Bone Marrow | + + + + + + + | Myeloid Cell, Hyperplasia | 2 3 2 2 2 | __________________________________________________________________________| Lymph Node | + + + + + + + + + + + + | Inguinal, Hyperplasia, Lymphoid | 3 | Mediastinal, Congestion | | Mediastinal, Hyperplasia, Lymphoid | | __________________________________________________________________________| Lymph Node, Mandibular | + + + + + M | _____________________________________________________________________________________________________________________| Page 81 NTP Experiment-Test: 05007-05 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 08:05:11 _____________________________________________________________________________________________________________________ | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 5| 7| 7| 7| 7| 7| 7| 7| 7| 7| 5| 7| 7| 7| 7| DAY ON TEST | 0| 3| 3| 3| 3| 0| 3| 3| 3| 3| 8| 3| 3| 3| 3| 3| 3| 3| 3| 3| 9| 0| 0| 3| 3| | 6| 4| 4| 4| 4| 8| 4| 4| 4| 5| 1| 5| 5| 5| 5| 5| 5| 5| 5| 5| 6| 7| 8| 5| 5| _____________________________________________________________________________________________________________________| | 0| 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 | 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| 2.5% | 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| _____________________________________________________________________________________________________________________| HEMATOPOIETIC SYSTEM - cont | | | | Hyperplasia, Lymphoid | 2 2 | Pigmentation | 2 | __________________________________________________________________________| Lymph Node, Mesenteric | + + + + + + + + + + + + | Angiectasis | 3 | Congestion | 3 3 2 | Hemorrhage | | Hyperplasia, Lymphoid | 3 2 2 2 2 2 3 | Inflammation, Acute | 3 | Inflammation, Chronic | | __________________________________________________________________________| Spleen | + + + + + + + + + + + | Hematopoietic Cell Proliferation | 3 3 3 2 3 2 | Hyperplasia, Lymphoid | | Pigmentation | 2 | __________________________________________________________________________| Thymus | + + + + + + + | Cyst | X | Hyperplasia, Lymphoid | 2 | _____________________________________________________________________________________________________________________| INTEGUMENTARY SYSTEM | | | | __________________________________________________________________________| Mammary Gland | M M M M M M | __________________________________________________________________________| Skin | + + + + + + + + + + + + + + + + + + + + +| Alopecia | 2 | Angiectasis | 3 | Erosion | | Hyperplasia | 2 | Inflammation, Chronic | 3 3 3 2| Inflammation, Chronic Active | 3 | Ulcer | 3 3 4 | Prepuce, Inflammation, Chronic | 2 | _____________________________________________________________________________________________________________________| MUSCULOSKELETAL SYSTEM | | | | __________________________________________________________________________| Bone | + + + + + + | __________________________________________________________________________| Skeletal Muscle | | _____________________________________________________________________________________________________________________| NERVOUS SYSTEM | | | | __________________________________________________________________________| Brain | + + + + + + | Mineralization | 2 2 2 2 | _____________________________________________________________________________________________________________________| RESPIRATORY SYSTEM | | | | __________________________________________________________________________| Lung | + + + + + + + + + | Congestion | | Hemorrhage | | Infiltration Cellular, Lymphocyte | 2 2 2 2 2 2 | __________________________________________________________________________| Nose | + + + + + + | Lumen, Hemorrhage | 2 2 2 | _____________________________________________________________________________________________________________________| Page 82 NTP Experiment-Test: 05007-05 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 08:05:11 _____________________________________________________________________________________________________________________ | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 5| 7| 7| 7| 7| 7| 7| 7| 7| 7| 5| 7| 7| 7| 7| DAY ON TEST | 0| 3| 3| 3| 3| 0| 3| 3| 3| 3| 8| 3| 3| 3| 3| 3| 3| 3| 3| 3| 9| 0| 0| 3| 3| | 6| 4| 4| 4| 4| 8| 4| 4| 4| 5| 1| 5| 5| 5| 5| 5| 5| 5| 5| 5| 6| 7| 8| 5| 5| _____________________________________________________________________________________________________________________| | 0| 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 | 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| 2.5% | 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| _____________________________________________________________________________________________________________________| RESPIRATORY SYSTEM - cont | | | | Nasolacrimal Duct, Inflammation, | | Acute | 1 | Olfactory Epithelium, Degeneration | 2 | __________________________________________________________________________| Trachea | + + + + + + | _____________________________________________________________________________________________________________________| SPECIAL SENSES SYSTEM | | | | __________________________________________________________________________| Eye | + + | __________________________________________________________________________| Harderian Gland | + + | _____________________________________________________________________________________________________________________| URINARY SYSTEM | | | | __________________________________________________________________________| Kidney | + + + + + + | Congestion | | Hemorrhage | | Infiltration Cellular, Lymphocyte | 2 2 2 2 | Inflammation, Chronic | 3 | Glomerulus, Renal Tubule, | | Mineralization | | Renal Tubule, Ectasia | | Renal Tubule, Mineralization | | Renal Tubule, Necrosis | | Renal Tubule, Regeneration | 1 | __________________________________________________________________________| Urethra | + + + | Calculus Micro Observation Only | X X X | __________________________________________________________________________| Urinary Bladder | + + + + + + | Ectasia | 2 | Infiltration Cellular, Lymphocyte | 2 2 | _____________________________________________________________________________________________________________________| Page 83 NTP Experiment-Test: 05007-05 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 08:05:11 __________________________________________________________________________________________________________________________________ | 3| 4| 4| 4| 4| 7| 7| 7| 7| 7| | | DAY ON TEST | 1| 5| 5| 5| 5| 3| 3| 3| 3| 3| | | | 0| 7| 7| 7| 7| 5| 5| 5| 5| 5| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | B6C3F1 MICE MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| | A | 2.5% | 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| | L | | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| | | __________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM | | | | | | __________________________________________________________________________|____________| Esophagus | | 15 | __________________________________________________________________________|____________| Gallbladder | | 15 | Ectasia | | 1 3.0| Infiltration Cellular, Lymphocyte | | 2 2.0| __________________________________________________________________________|____________| Intestine Large | | 16 | __________________________________________________________________________|____________| Intestine Large, Cecum | | 16 | __________________________________________________________________________|____________| Intestine Large, Colon | | 16 | __________________________________________________________________________|____________| Intestine Large, Rectum | | 16 | __________________________________________________________________________|____________| Intestine Small | | 16 | __________________________________________________________________________|____________| Intestine Small, Duodenum | | 16 | __________________________________________________________________________|____________| Intestine Small, Ileum | | 15 | __________________________________________________________________________|____________| Intestine Small, Jejunum | | 16 | __________________________________________________________________________|____________| Liver | | 23 | Developmental Malformation | | 1 | Focal Cellular Change | | 1 | Infiltration Cellular, Lymphocyte | | 5 1.6| Necrosis | | 3 3.0| Bile Duct, Cyst | | 1 | __________________________________________________________________________|____________| Mesentery | | 5 | Fat, Necrosis | | 3 3.7| __________________________________________________________________________|____________| Pancreas | + | 17 | Infiltration Cellular, Lymphocyte | | 3 2.0| Acinus, Atrophy | 4 | 2 3.0| Duct, Cyst | X | 1 | __________________________________________________________________________|____________| Salivary Glands | | 16 | Infiltration Cellular, Lymphocyte | | 9 1.9| __________________________________________________________________________|____________| Stomach | + + + + + | 50 | __________________________________________________________________________|____________| Stomach, Forestomach | + + + + + | 50 | Hyperkeratosis | | 1 1.0| Hyperplasia, Squamous | | 4 1.8| Inflammation, Acute | | 3 2.0| Inflammation, Chronic Active | | 1 2.0| Mineralization | | 2 1.0| Glandular, Cyst Epithelial Inclusion | | 1 | __________________________________________________________________________|____________| Stomach, Glandular | + + + + + | 50 | Infiltration Cellular, Lymphocyte | 2 | 10 2.0| Inflammation, Acute | | 2 2.0| Inflammation, Chronic Active | | 1 4.0| Mineralization | | 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 84 NTP Experiment-Test: 05007-05 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 08:05:11 __________________________________________________________________________________________________________________________________ | 3| 4| 4| 4| 4| 7| 7| 7| 7| 7| | | DAY ON TEST | 1| 5| 5| 5| 5| 3| 3| 3| 3| 3| | | | 0| 7| 7| 7| 7| 5| 5| 5| 5| 5| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | B6C3F1 MICE MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| | A | 2.5% | 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| | L | | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| | | __________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - cont | | | | | | Mucosa, Dilatation | 2 | 1 2.0| Mucosa, Ectasia | | 1 2.0| Mucosa, Mineralization | | 1 3.0| _____________________________________________________________________________________________________________________| | CARDIOVASCULAR SYSTEM | | | | | | __________________________________________________________________________|____________| Heart | | 16 | Mineralization | | 1 3.0| _____________________________________________________________________________________________________________________| | ENDOCRINE SYSTEM | | | | | | __________________________________________________________________________|____________| Adrenal Gland | | 16 | __________________________________________________________________________|____________| Adrenal Gland, Cortex | | 16 | Spindle Cell, Hyperplasia, Lymphoid | | 1 2.0| Spindle Cell, Hyperplasia | | 14 2.0| __________________________________________________________________________|____________| Adrenal Gland, Medulla | | 16 | Hyperplasia | | 1 2.0| __________________________________________________________________________|____________| Islets, Pancreatic | + | 17 | __________________________________________________________________________|____________| Parathyroid Gland | | 7 | __________________________________________________________________________|____________| Pituitary Gland | | 15 | __________________________________________________________________________|____________| Thyroid Gland | | 16 | Infiltration Cellular, Lymphocyte | | 1 2.0| Follicle, Ectasia | | 1 2.0| Follicle, Hyperplasia, Cystic | | 1 3.0| _____________________________________________________________________________________________________________________| | GENERAL BODY SYSTEM | | | | | | None | | | _____________________________________________________________________________________________________________________| | GENITAL SYSTEM | | | | | | __________________________________________________________________________|____________| Epididymis | | 16 | Infiltration Cellular, Lymphocyte | | 4 2.0| __________________________________________________________________________|____________| Preputial Gland | + + | 14 | Abscess | | 5 3.8| Infiltration Cellular, Lymphocyte | | 3 2.3| Inflammation, Chronic | 3 | 1 3.0| Inflammation, Chronic Active | | 3 3.0| Duct, Cyst | X | 2 2.0| __________________________________________________________________________|____________| Prostate | | 17 | __________________________________________________________________________|____________| Seminal Vesicle | | 16 | __________________________________________________________________________|____________| Testes | + | 17 | Mineralization | | 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 85 NTP Experiment-Test: 05007-05 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 08:05:11 __________________________________________________________________________________________________________________________________ | 3| 4| 4| 4| 4| 7| 7| 7| 7| 7| | | DAY ON TEST | 1| 5| 5| 5| 5| 3| 3| 3| 3| 3| | | | 0| 7| 7| 7| 7| 5| 5| 5| 5| 5| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | B6C3F1 MICE MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| | A | 2.5% | 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| | L | | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| | | __________________________________________________________________________________________________________________________________ GENITAL SYSTEM - cont | | | | | | Necrosis | 4 | 1 4.0| _____________________________________________________________________________________________________________________| | HEMATOPOIETIC SYSTEM | | | | | | __________________________________________________________________________|____________| Bone Marrow | | 17 | Myeloid Cell, Hyperplasia | | 12 2.1| __________________________________________________________________________|____________| Lymph Node | + + | 28 | Inguinal, Hyperplasia, Lymphoid | | 3 2.7| Mediastinal, Congestion | | 1 2.0| Mediastinal, Hyperplasia, Lymphoid | | 2 2.0| __________________________________________________________________________|____________| Lymph Node, Mandibular | | 14 | Hyperplasia, Lymphoid | | 4 2.0| Pigmentation | | 1 2.0| __________________________________________________________________________|____________| Lymph Node, Mesenteric | + + | 28 | Angiectasis | | 2 3.0| Congestion | 2 3 | 11 2.8| Hemorrhage | | 2 4.0| Hyperplasia, Lymphoid | 2 3 | 15 2.3| Inflammation, Acute | | 1 3.0| Inflammation, Chronic | | 1 2.0| __________________________________________________________________________|____________| Spleen | | 21 | Hematopoietic Cell Proliferation | | 13 2.5| Hyperplasia, Lymphoid | | 2 2.0| Pigmentation | | 2 2.0| __________________________________________________________________________|____________| Thymus | | 16 | Cyst | | 1 | Hyperplasia, Lymphoid | | 1 2.0| _____________________________________________________________________________________________________________________| | INTEGUMENTARY SYSTEM | | | | | | __________________________________________________________________________|____________| Mammary Gland | | | __________________________________________________________________________|____________| Skin | + + + + + | 42 | Alopecia | | 1 2.0| Angiectasis | | 1 3.0| Erosion | | 1 2.0| Hyperplasia | | 1 2.0| Inflammation, Chronic | 2 4 4 3 3 | 15 2.9| Inflammation, Chronic Active | | 1 3.0| Ulcer | 4 | 6 3.5| Prepuce, Inflammation, Chronic | | 1 2.0| _____________________________________________________________________________________________________________________| | 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 86 NTP Experiment-Test: 05007-05 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 08:05:11 __________________________________________________________________________________________________________________________________ | 3| 4| 4| 4| 4| 7| 7| 7| 7| 7| | | DAY ON TEST | 1| 5| 5| 5| 5| 3| 3| 3| 3| 3| | | | 0| 7| 7| 7| 7| 5| 5| 5| 5| 5| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | B6C3F1 MICE MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| | A | 2.5% | 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| | L | | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| | | __________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM - cont | | | | | | | | | __________________________________________________________________________|____________| Bone | | 16 | __________________________________________________________________________|____________| Skeletal Muscle | | 1 | _____________________________________________________________________________________________________________________| | NERVOUS SYSTEM | | | | | | __________________________________________________________________________|____________| Brain | | 16 | Mineralization | | 9 2.0| _____________________________________________________________________________________________________________________| | RESPIRATORY SYSTEM | | | | | | __________________________________________________________________________|____________| Lung | + | 21 | Congestion | | 1 2.0| Hemorrhage | | 1 2.0| Infiltration Cellular, Lymphocyte | | 12 1.9| __________________________________________________________________________|____________| Nose | | 16 | Lumen, Hemorrhage | | 5 2.0| Nasolacrimal Duct, Inflammation, | | | Acute | | 4 1.8| Olfactory Epithelium, Degeneration | | 6 1.5| __________________________________________________________________________|____________| Trachea | | 16 | _____________________________________________________________________________________________________________________| | SPECIAL SENSES SYSTEM | | | | | | __________________________________________________________________________|____________| Eye | | 2 | __________________________________________________________________________|____________| Harderian Gland | + | 3 | _____________________________________________________________________________________________________________________| | URINARY SYSTEM | | | | | | __________________________________________________________________________|____________| Kidney | | 16 | Congestion | | 1 3.0| Hemorrhage | | 1 3.0| Infiltration Cellular, Lymphocyte | | 12 1.8| Inflammation, Chronic | | 2 2.5| Glomerulus, Renal Tubule, | | | Mineralization | | 1 4.0| Renal Tubule, Ectasia | | 1 2.0| Renal Tubule, Mineralization | | 1 2.0| Renal Tubule, Necrosis | | 1 2.0| Renal Tubule, Regeneration | | 3 1.3| __________________________________________________________________________|____________| Urethra | | 5 | Calculus Micro Observation Only | | 5 | __________________________________________________________________________|____________| Urinary Bladder | | 16 | __________________________________________________________________________________________________________________________________ * : 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 87 NTP Experiment-Test: 05007-05 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 08:05:11 __________________________________________________________________________________________________________________________________ | 3| 4| 4| 4| 4| 7| 7| 7| 7| 7| | | DAY ON TEST | 1| 5| 5| 5| 5| 3| 3| 3| 3| 3| | | | 0| 7| 7| 7| 7| 5| 5| 5| 5| 5| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | B6C3F1 MICE MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| | A | 2.5% | 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| | L | | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| | | __________________________________________________________________________________________________________________________________ URINARY SYSTEM - cont | | | | | | Ectasia | | 2 2.0| Infiltration Cellular, Lymphocyte | | 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 88 ------------------------------------------------------------ ---------- END OF REPORT ---------- ------------------------------------------------------------