TDMS Study 05007-06 Pathology Tables
NTP Experiment-Test: 05007-06 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 07:49:23 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: 05007-06 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 07:49:23 _____________________________________________________________________________________________________________________ | 5| 5| 7| 7| 7| 6| 7| 7| 7| 7| 6| 6| 7| 7| 7| 6| 6| 7| 7| 7| 4| 4| 4| 4| 4| DAY ON TEST | 1| 4| 2| 2| 2| 2| 1| 2| 2| 2| 4| 7| 0| 1| 3| 1| 6| 3| 3| 3| 6| 6| 6| 6| 6| | 4| 8| 9| 9| 9| 9| 0| 9| 9| 9| 6| 5| 9| 6| 0| 7| 2| 0| 0| 0| 3| 3| 3| 3| 3| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| FISCHER 344 RATS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 4| 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 | + + + + + + + + + + + + + + + + + + + + | __________________________________________________________________________| Intestine Large | + + + + + + + + + + + + + + + + + + + + | __________________________________________________________________________| Intestine Large, Cecum | + + + + + + + + + + + + + + + + + + + + | Inflammation, Acute | | Parasite Metazoan | X X X | __________________________________________________________________________| Intestine Large, Colon | + + + + + + + + + + + + + + + + + + + + | Parasite Metazoan | X X | __________________________________________________________________________| Intestine Large, Rectum | + + + + + + + + + + + + + + + + + + + + | Parasite Metazoan | X X X X | __________________________________________________________________________| Intestine Small | + + + + + + + + + + + + + + + + + + + + | __________________________________________________________________________| Intestine Small, Duodenum | + + + + + + + + + + + + + + + + + + + + | __________________________________________________________________________| Intestine Small, Ileum | + + + + + + + + + + + + + + + + + + + + | __________________________________________________________________________| Intestine Small, Jejunum | + + + + + + + + + + + + + + + + + + + + | __________________________________________________________________________| Liver | + + + + + + + + + + + + + + + + + + + + | Angiectasis | 2 2 2 | Basophilic Focus | X X X X X X X X X X X X X X X X | Developmental Malformation | X X X | Fatty Change | 1 | Granuloma | 3 2 2 2 | Hematopoietic Cell Proliferation | | Necrosis | 2 | Bile Duct, Hyperplasia | 1 1 2 1 1 1 1 3 | Hepatocyte, Hyperplasia | | Portal, Inflammation, Chronic | 2 1 2 1 2 | __________________________________________________________________________| Mesentery | + + + + | Fat, Inflammation, Acute | 4 | Fat, Necrosis | 3 3 4 | __________________________________________________________________________| Pancreas | + + + + + + + + + + + + + + + + + + + + | Acinus, Atrophy | 2 1 1 2 4 2 1 1 | Acinus, Hyperplasia | | __________________________________________________________________________| Salivary Glands | + + + + + + + + + + + + + + + + + + + + | Inflammation, Acute | 2 | Acinus, Atrophy | | Acinus, Hyperplasia | | Duct, Ectasia | | __________________________________________________________________________| Stomach | + + + + + + + + + + + + + + + + + + + + | __________________________________________________________________________| Stomach, Forestomach | + + + + + + + + + + + + + + + + + + + + | Hyperkeratosis | 2 | Inflammation, Acute | 2 | Inflammation, Chronic | | Mineralization | | Ulcer | | __________________________________________________________________________| Stomach, Glandular | + + + + + + + + + + + + + + + + + + + + | Inflammation, Acute | | _____________________________________________________________________________________________________________________| Page 2 NTP Experiment-Test: 05007-06 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 07:49:23 _____________________________________________________________________________________________________________________ | 5| 5| 7| 7| 7| 6| 7| 7| 7| 7| 6| 6| 7| 7| 7| 6| 6| 7| 7| 7| 4| 4| 4| 4| 4| DAY ON TEST | 1| 4| 2| 2| 2| 2| 1| 2| 2| 2| 4| 7| 0| 1| 3| 1| 6| 3| 3| 3| 6| 6| 6| 6| 6| | 4| 8| 9| 9| 9| 9| 0| 9| 9| 9| 6| 5| 9| 6| 0| 7| 2| 0| 0| 0| 3| 3| 3| 3| 3| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| FISCHER 344 RATS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 4| 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 | | | | Mineralization | 3 | Mucosa, Dilatation | 2 2 2 2 2 2 2 2 1 2 2 2 2 2 2 2 2 | __________________________________________________________________________| Tooth | + | Peridontal Tissue, Hemorrhage | 3 | _____________________________________________________________________________________________________________________| CARDIOVASCULAR SYSTEM | | | | __________________________________________________________________________| Heart | + + + + + + + + + + + + + + + + + + + + | Cardiomyopathy, Chronic | 2 2 2 1 1 2 2 2 2 2 2 2 2 1 2 2 2 2 | Hemorrhage | | Coronary Artery, Mineralization | 2 | _____________________________________________________________________________________________________________________| ENDOCRINE SYSTEM | | | | __________________________________________________________________________| Adrenal Gland | + + + + + + + + + + + + + + + + + + + + | __________________________________________________________________________| Adrenal Gland, Cortex | + + + + + + + + + + + + + + + + + + + + | Accessory Adrenal Cortical Nodule | | Angiectasis | | Cyst | | Degeneration, Fatty | 3 1 3 3 2 2 2 2 2 | Hematopoietic Cell Proliferation | | Hyperplasia | 1 2 | Hypertrophy | 2 1 | Pigmentation | 1 1 1 1 1 1 2 1 | __________________________________________________________________________| Adrenal Gland, Medulla | + + + + + + + + + + + + + + + + + + + + | Hematopoietic Cell Proliferation | | Hyperplasia | 2 1 2 2 2 | __________________________________________________________________________| Islets, Pancreatic | + + + + + + + + + + + + + + + + + + + + | __________________________________________________________________________| Parathyroid Gland | + + + M + + + + + + + M + + M + + + M + | __________________________________________________________________________| Pituitary Gland | + + + + + + + + + + + + + + + + + + + + | Pars Distalis, Cyst | X X X X X X X | Pars Distalis, Hyperplasia | 2 2 2 | Pars Distalis, Metaplasia, Osseous | | Pars Intermedia, Cyst | X | __________________________________________________________________________| Thyroid Gland | + + + + + + + + + + + + + + + + + + + + | C-Cell, Hyperplasia | 2 2 2 2 1 2 2 1 1 2 1 3 1 1 1 | _____________________________________________________________________________________________________________________| GENERAL BODY SYSTEM | | | | None | | _____________________________________________________________________________________________________________________| GENITAL SYSTEM | | | | __________________________________________________________________________| Clitoral Gland | + + + M + + + + + + + + + + + + + + + + | Abscess | | Inflammation, Chronic | 1 1 2 1 3 | Inflammation, Chronic Active | 1 3 2 | Duct, Ectasia | 3 3 3 | _____________________________________________________________________________________________________________________| Page 3 NTP Experiment-Test: 05007-06 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 07:49:23 _____________________________________________________________________________________________________________________ | 5| 5| 7| 7| 7| 6| 7| 7| 7| 7| 6| 6| 7| 7| 7| 6| 6| 7| 7| 7| 4| 4| 4| 4| 4| DAY ON TEST | 1| 4| 2| 2| 2| 2| 1| 2| 2| 2| 4| 7| 0| 1| 3| 1| 6| 3| 3| 3| 6| 6| 6| 6| 6| | 4| 8| 9| 9| 9| 9| 0| 9| 9| 9| 6| 5| 9| 6| 0| 7| 2| 0| 0| 0| 3| 3| 3| 3| 3| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| FISCHER 344 RATS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 4| 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 - cont | | | | __________________________________________________________________________| Ovary | + + + + + + + + + + + + + + + + + + + + | Periovarian Tissue, Cyst | | __________________________________________________________________________| Uterus | + + + + + + + + + + + + + + + + + + + + | Ectasia | | Endometrium, Hyperplasia, Cystic | 2 3 2 | __________________________________________________________________________| Vagina | | _____________________________________________________________________________________________________________________| HEMATOPOIETIC SYSTEM | | | | __________________________________________________________________________| Blood | + + | __________________________________________________________________________| Bone Marrow | + + + + + + + + + + + + + + + + + + + + | Myelofibrosis | | __________________________________________________________________________| Lymph Node | + + + + + + + + + + + + + + + + + + + + | Inguinal, Hyperplasia, Lymphoid | | Mediastinal, Congestion | 3 | Mediastinal, Hyperplasia, Lymphoid | 3 2 2 2 | Mediastinal, Hyperplasia, Reticulum | | Cell | 2 | Pancreatic, Congestion | | __________________________________________________________________________| Lymph Node, Mandibular | + + + + + + + + + + + + + + + + + + + + | Hyperplasia, Lymphoid | 2 2 3 2 2 2 2 2 2 2 2 2 | __________________________________________________________________________| Lymph Node, Mesenteric | + + + + + + + + + + + + + + + + + + + + | Congestion | | Hyperplasia, Lymphoid | 2 2 3 2 2 2 3 2 2 2 | Hyperplasia, Reticulum Cell | 2 | __________________________________________________________________________| Spleen | + + + + + + + + + + + + + + + + + + + + | Hematopoietic Cell Proliferation | 2 2 2 3 2 3 2 3 2 2 2 3 3 3 2 3 | Hyperplasia, Histiocytic, Lymphoid | | Hyperplasia, Lymphoid | | Pigmentation | 2 3 3 3 2 2 2 3 3 3 3 2 3 2 2 3 | Capsule, Fibrosis | | __________________________________________________________________________| Thymus | + M + + + + M + + + + + + + + + + M + + | Cyst | X | Hemorrhage | 4 | Hyperplasia, Lymphoid | 2 | _____________________________________________________________________________________________________________________| INTEGUMENTARY SYSTEM | | | | __________________________________________________________________________| Mammary Gland | + + + + + + + + + + + + + + + + + + + + | Acinus, Ectasia | 2 3 4 4 3 3 3 3 3 2 2 4 4 3 2 2 3 4 3 4 | Acinus, Hyperplasia | 4 2 | Duct, Ectasia | 3 3 4 3 4 3 | __________________________________________________________________________| Skin | + + + + + + + + + + + + + + + + + + + + | Cyst Epithelial Inclusion | X X | Inflammation, Chronic Active | 2 2 | Inflammation, Suppurative | 2 | _____________________________________________________________________________________________________________________| Page 4 NTP Experiment-Test: 05007-06 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 07:49:23 _____________________________________________________________________________________________________________________ | 5| 5| 7| 7| 7| 6| 7| 7| 7| 7| 6| 6| 7| 7| 7| 6| 6| 7| 7| 7| 4| 4| 4| 4| 4| DAY ON TEST | 1| 4| 2| 2| 2| 2| 1| 2| 2| 2| 4| 7| 0| 1| 3| 1| 6| 3| 3| 3| 6| 6| 6| 6| 6| | 4| 8| 9| 9| 9| 9| 0| 9| 9| 9| 6| 5| 9| 6| 0| 7| 2| 0| 0| 0| 3| 3| 3| 3| 3| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| FISCHER 344 RATS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 4| 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| _____________________________________________________________________________________________________________________| INTEGUMENTARY SYSTEM - cont | | | | _____________________________________________________________________________________________________________________| MUSCULOSKELETAL SYSTEM | | | | __________________________________________________________________________| Bone | + + + + + + + + + + + + + + + + + + + + | Cranium, Fibrous Osteodystrophy | 4 | Cranium, Osteopetrosis | 3 3 | Femur, Fibrous Osteodystrophy | 4 | Femur, Osteopetrosis | 3 | Rib, Hyperplasia | 2 | __________________________________________________________________________| Skeletal Muscle | | _____________________________________________________________________________________________________________________| NERVOUS SYSTEM | | | | __________________________________________________________________________| Brain | + + + + + + + + + + + + + + + + + + + + | Compression | X X X X | Hemorrhage | 3 | _____________________________________________________________________________________________________________________| RESPIRATORY SYSTEM | | | | __________________________________________________________________________| Lung | + + + + + + + + + + + + + + + + + + + + | Congestion | 2 | Hemorrhage | 1 1 2 2 2 | Alveolar Epithelium, Hyperplasia | | Alveolus, Infiltration Cellular, | | Histiocyte | 2 2 1 1 2 2 2 1 1 1 2 2 2 | Arteriole, Mineralization | 2 2 1 2 2 2 2 1 2 2 | Interstitium, Inflammation, Chronic | | __________________________________________________________________________| Nose | + + + + + + + + + + + + + + + + + + + + | Lumen, Hemorrhage | 2 2 1 2 2 1 1 1 1 2 1 | Mucosa, Cyst | X | Mucosa, Inflammation, Acute | 2 4 | Nasolacrimal Duct, Hemorrhage | 2 | Nasolacrimal Duct, Inflammation, | | Acute | 2 2 2 2 3 2 | Olfactory Epithelium, Degeneration | 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 | Respiratory Epithelium, Degeneration | 2 2 1 1 2 1 1 1 1 1 2 2 | Vomeronasal Organ, Inflammation, | | Acute | 2 | __________________________________________________________________________| Trachea | + + + + + + + + + + + + + + + + + + + + | _____________________________________________________________________________________________________________________| SPECIAL SENSES SYSTEM | | | | __________________________________________________________________________| Eye | + + | Cataract | 3 | Hemorrhage | | Synechia | | Retina, Degeneration | 4 4 | _____________________________________________________________________________________________________________________| URINARY SYSTEM | | _____________________________________________________________________________________________________________________| Page 5 NTP Experiment-Test: 05007-06 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 07:49:23 _____________________________________________________________________________________________________________________ | 5| 5| 7| 7| 7| 6| 7| 7| 7| 7| 6| 6| 7| 7| 7| 6| 6| 7| 7| 7| 4| 4| 4| 4| 4| DAY ON TEST | 1| 4| 2| 2| 2| 2| 1| 2| 2| 2| 4| 7| 0| 1| 3| 1| 6| 3| 3| 3| 6| 6| 6| 6| 6| | 4| 8| 9| 9| 9| 9| 0| 9| 9| 9| 6| 5| 9| 6| 0| 7| 2| 0| 0| 0| 3| 3| 3| 3| 3| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| FISCHER 344 RATS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 4| 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| _____________________________________________________________________________________________________________________| URINARY SYSTEM - cont | | | | | | __________________________________________________________________________| Kidney | + + + + + + + + + + + + + + + + + + + + | Nephropathy, Chronic | 2 2 3 2 3 3 2 2 2 3 4 3 2 2 2 2 2 2 3 | Renal Tubule, Pigmentation | 1 2 2 2 2 2 2 1 2 2 2 2 2 2 3 2 1 2 2 | __________________________________________________________________________| Urinary Bladder | + + + + + + + + + + + + + + + + + + + + | Mineralization | 2 | _____________________________________________________________________________________________________________________| Page 6 NTP Experiment-Test: 05007-06 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 07:49:23 _____________________________________________________________________________________________________________________ | 5| 5| 6| 7| 7| 1| 6| 7| 7| 7| 6| 6| 7| 7| 7| 3| 6| 6| 6| 7| 4| 4| 4| 4| 4| DAY ON TEST | 7| 9| 4| 3| 3| 9| 4| 0| 3| 3| 3| 4| 1| 3| 3| 6| 1| 3| 9| 3| 6| 6| 6| 6| 6| | 3| 4| 5| 0| 0| 5| 4| 1| 0| 0| 1| 0| 0| 0| 0| 7| 7| 0| 9| 0| 3| 3| 3| 3| 3| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| FISCHER 344 RATS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 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 | + + + + + M + + + + + + + + + + + + + + | __________________________________________________________________________| Intestine Large | + + + + + + + + + + + + + + + + + + + + | __________________________________________________________________________| Intestine Large, Cecum | + + + + + + + + + + + + + + + + + + + + | Inflammation, Acute | 4 | Parasite Metazoan | | __________________________________________________________________________| Intestine Large, Colon | + + + + + + + + + + + + + + + + + + + + | Parasite Metazoan | | __________________________________________________________________________| Intestine Large, Rectum | + + + + + + + + + + + + + + + + + + + + | Parasite Metazoan | X | __________________________________________________________________________| Intestine Small | + + + + + + + + + + + + + + + + + + + + | __________________________________________________________________________| Intestine Small, Duodenum | + + + + + + + + + + + + + + + + + + + + | __________________________________________________________________________| Intestine Small, Ileum | + + + + + + + + + + + + + + + + + + + + | __________________________________________________________________________| Intestine Small, Jejunum | + + + + + + + + + + + + + + + + + + + + | __________________________________________________________________________| Liver | + + + + + + + + + + + + + + + + + + + + | Angiectasis | | Basophilic Focus | X X X X X X X X X X X X X X X X | Developmental Malformation | X X | Fatty Change | 2 2 3 2 | Granuloma | | Hematopoietic Cell Proliferation | 1 2 | Necrosis | 3 | Bile Duct, Hyperplasia | 1 1 2 1 2 1 1 1 2 | Hepatocyte, Hyperplasia | 2 3 | Portal, Inflammation, Chronic | 1 3 2 1 | __________________________________________________________________________| Mesentery | + + + + | Fat, Inflammation, Acute | | Fat, Necrosis | 3 3 | __________________________________________________________________________| Pancreas | + + + + + + + + + + + + + + + + + + + + | Acinus, Atrophy | 2 2 3 3 2 2 | Acinus, Hyperplasia | | __________________________________________________________________________| Salivary Glands | + + + + + + + + + + + + + + + + + + + + | Inflammation, Acute | 3 | Acinus, Atrophy | | Acinus, Hyperplasia | | Duct, Ectasia | 3 | __________________________________________________________________________| Stomach | + + + + + + + + + + + + + + + + + + + + | __________________________________________________________________________| Stomach, Forestomach | + + + + + + + + + + + + + + + + + + + + | Hyperkeratosis | | Inflammation, Acute | 3 | Inflammation, Chronic | 1 | Mineralization | 2 | Ulcer | 3 | __________________________________________________________________________| Stomach, Glandular | + + + + + + + + + + + + + + + + + + + + | Inflammation, Acute | 3 | _____________________________________________________________________________________________________________________| Page 7 NTP Experiment-Test: 05007-06 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 07:49:23 _____________________________________________________________________________________________________________________ | 5| 5| 6| 7| 7| 1| 6| 7| 7| 7| 6| 6| 7| 7| 7| 3| 6| 6| 6| 7| 4| 4| 4| 4| 4| DAY ON TEST | 7| 9| 4| 3| 3| 9| 4| 0| 3| 3| 3| 4| 1| 3| 3| 6| 1| 3| 9| 3| 6| 6| 6| 6| 6| | 3| 4| 5| 0| 0| 5| 4| 1| 0| 0| 1| 0| 0| 0| 0| 7| 7| 0| 9| 0| 3| 3| 3| 3| 3| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| FISCHER 344 RATS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 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 | | | | Mineralization | 3 2 | Mucosa, Dilatation | 2 2 2 2 1 3 2 2 2 2 1 2 2 2 2 | __________________________________________________________________________| Tooth | | Peridontal Tissue, Hemorrhage | | _____________________________________________________________________________________________________________________| CARDIOVASCULAR SYSTEM | | | | __________________________________________________________________________| Heart | + + + + + + + + + + + + + + + + + + + + | Cardiomyopathy, Chronic | 3 2 2 2 2 2 2 2 3 2 2 2 2 2 2 2 | Hemorrhage | 2 | Coronary Artery, Mineralization | | _____________________________________________________________________________________________________________________| ENDOCRINE SYSTEM | | | | __________________________________________________________________________| Adrenal Gland | + + + + + + + + + + + + + + + + + + + + | __________________________________________________________________________| Adrenal Gland, Cortex | + + + + + + + + + + + + + + + + + + + + | Accessory Adrenal Cortical Nodule | X | Angiectasis | | Cyst | X | Degeneration, Fatty | 2 2 2 2 1 2 2 1 1 1 2 2 | Hematopoietic Cell Proliferation | 2 | Hyperplasia | 2 1 1 2 | Hypertrophy | 2 2 | Pigmentation | 1 2 1 1 1 2 1 1 1 1 1 1 | __________________________________________________________________________| Adrenal Gland, Medulla | + + + + + + + + + + + + + + + + + + + + | Hematopoietic Cell Proliferation | 2 | Hyperplasia | 2 2 | __________________________________________________________________________| Islets, Pancreatic | + + + + + + + + + + + + + + + + + + + + | __________________________________________________________________________| Parathyroid Gland | + + + + + + + M + + + + M M M + + + + + | __________________________________________________________________________| Pituitary Gland | + + + + + + + + + + + + + + + + + + + + | Pars Distalis, Cyst | X X | Pars Distalis, Hyperplasia | 3 2 | Pars Distalis, Metaplasia, Osseous | 2 | Pars Intermedia, Cyst | | __________________________________________________________________________| Thyroid Gland | + + + + + + + + + + + + + + + + + + + + | C-Cell, Hyperplasia | 1 1 2 2 1 2 1 1 1 1 3 | _____________________________________________________________________________________________________________________| GENERAL BODY SYSTEM | | | | None | | _____________________________________________________________________________________________________________________| GENITAL SYSTEM | | | | __________________________________________________________________________| Clitoral Gland | + + + + + + + + + + + + + + + + + + + + | Abscess | 3 | Inflammation, Chronic | 2 1 1 | Inflammation, Chronic Active | 2 3 2 | Duct, Ectasia | 3 2 | _____________________________________________________________________________________________________________________| Page 8 NTP Experiment-Test: 05007-06 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 07:49:23 _____________________________________________________________________________________________________________________ | 5| 5| 6| 7| 7| 1| 6| 7| 7| 7| 6| 6| 7| 7| 7| 3| 6| 6| 6| 7| 4| 4| 4| 4| 4| DAY ON TEST | 7| 9| 4| 3| 3| 9| 4| 0| 3| 3| 3| 4| 1| 3| 3| 6| 1| 3| 9| 3| 6| 6| 6| 6| 6| | 3| 4| 5| 0| 0| 5| 4| 1| 0| 0| 1| 0| 0| 0| 0| 7| 7| 0| 9| 0| 3| 3| 3| 3| 3| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| FISCHER 344 RATS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 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 - cont | | | | __________________________________________________________________________| Ovary | + + + + + + + + + + + + + + + + + + + + | Periovarian Tissue, Cyst | | __________________________________________________________________________| Uterus | + + + + + + + + + + + + + + + + + + + + | Ectasia | 3 3 | Endometrium, Hyperplasia, Cystic | 2 1 2 | __________________________________________________________________________| Vagina | + + + + + + | _____________________________________________________________________________________________________________________| HEMATOPOIETIC SYSTEM | | | | __________________________________________________________________________| Blood | | __________________________________________________________________________| Bone Marrow | + + + + + + + + + + + + + + + + + + + + | Myelofibrosis | | __________________________________________________________________________| Lymph Node | + + + + + + + + + + + + + + + + + + + + | Inguinal, Hyperplasia, Lymphoid | 2 | Mediastinal, Congestion | 4 3 | Mediastinal, Hyperplasia, Lymphoid | | Mediastinal, Hyperplasia, Reticulum | | Cell | | Pancreatic, Congestion | | __________________________________________________________________________| Lymph Node, Mandibular | + + + + + + + + + + + + + + + + + + + + | Hyperplasia, Lymphoid | 2 2 2 2 2 2 3 2 2 3 2 3 | __________________________________________________________________________| Lymph Node, Mesenteric | + + + + + + + + + + + + + + + + + + + + | Congestion | 2 | Hyperplasia, Lymphoid | 2 2 3 | Hyperplasia, Reticulum Cell | | __________________________________________________________________________| Spleen | + + + + + + + + + + + + + + + + + + + + | Hematopoietic Cell Proliferation | 2 2 2 3 2 1 2 3 2 2 3 2 2 2 2 2 2 2 | Hyperplasia, Histiocytic, Lymphoid | | Hyperplasia, Lymphoid | 2 2 | Pigmentation | 3 3 2 2 3 3 3 3 2 4 3 3 2 | Capsule, Fibrosis | 2 | __________________________________________________________________________| Thymus | + + + + + + + + + + + + + + + + + + + + | Cyst | | Hemorrhage | | Hyperplasia, Lymphoid | 2 | _____________________________________________________________________________________________________________________| INTEGUMENTARY SYSTEM | | | | __________________________________________________________________________| Mammary Gland | + + + + + + + + + + + + + + + + + + + + | Acinus, Ectasia | 2 3 4 2 4 3 4 4 3 2 2 2 4 2 2 3 | Acinus, Hyperplasia | 3 | Duct, Ectasia | 2 3 2 | __________________________________________________________________________| Skin | + + + + + + + + + + + + + + + + + + + + | Cyst Epithelial Inclusion | X | Inflammation, Chronic Active | | Inflammation, Suppurative | 3 | _____________________________________________________________________________________________________________________| Page 9 NTP Experiment-Test: 05007-06 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 07:49:23 _____________________________________________________________________________________________________________________ | 5| 5| 6| 7| 7| 1| 6| 7| 7| 7| 6| 6| 7| 7| 7| 3| 6| 6| 6| 7| 4| 4| 4| 4| 4| DAY ON TEST | 7| 9| 4| 3| 3| 9| 4| 0| 3| 3| 3| 4| 1| 3| 3| 6| 1| 3| 9| 3| 6| 6| 6| 6| 6| | 3| 4| 5| 0| 0| 5| 4| 1| 0| 0| 1| 0| 0| 0| 0| 7| 7| 0| 9| 0| 3| 3| 3| 3| 3| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| FISCHER 344 RATS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 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| _____________________________________________________________________________________________________________________| INTEGUMENTARY SYSTEM - cont | | | | _____________________________________________________________________________________________________________________| MUSCULOSKELETAL SYSTEM | | | | __________________________________________________________________________| Bone | + + + + + + + + + + + + + + + + + + + + | Cranium, Fibrous Osteodystrophy | | Cranium, Osteopetrosis | 4 4 3 | Femur, Fibrous Osteodystrophy | | Femur, Osteopetrosis | | Rib, Hyperplasia | | __________________________________________________________________________| Skeletal Muscle | + | _____________________________________________________________________________________________________________________| NERVOUS SYSTEM | | | | __________________________________________________________________________| Brain | + + + + + + + + + + + + + + + + + + + + | Compression | X X X X X X X X X X | Hemorrhage | | _____________________________________________________________________________________________________________________| RESPIRATORY SYSTEM | | | | __________________________________________________________________________| Lung | + + + + + + + + + + + + + + + + + + + + | Congestion | | Hemorrhage | 1 1 2 1 2 | Alveolar Epithelium, Hyperplasia | 2 | Alveolus, Infiltration Cellular, | | Histiocyte | 2 1 2 2 2 2 2 2 2 2 | Arteriole, Mineralization | 2 2 2 1 2 2 2 2 2 2 2 | Interstitium, Inflammation, Chronic | | __________________________________________________________________________| Nose | + + + + + + + + + + + + + + + + + + + + | Lumen, Hemorrhage | 1 2 2 1 2 2 2 | Mucosa, Cyst | | Mucosa, Inflammation, Acute | 3 | Nasolacrimal Duct, Hemorrhage | | Nasolacrimal Duct, Inflammation, | | Acute | 1 2 2 1 2 | Olfactory Epithelium, Degeneration | 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 | Respiratory Epithelium, Degeneration | 2 1 1 2 2 2 2 1 2 2 2 | Vomeronasal Organ, Inflammation, | | Acute | | __________________________________________________________________________| Trachea | + + + + + + + + + + + + + + + + + + + + | _____________________________________________________________________________________________________________________| SPECIAL SENSES SYSTEM | | | | __________________________________________________________________________| Eye | + | Cataract | 3 | Hemorrhage | | Synechia | | Retina, Degeneration | 4 | _____________________________________________________________________________________________________________________| URINARY SYSTEM | | _____________________________________________________________________________________________________________________| Page 10 NTP Experiment-Test: 05007-06 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 07:49:23 _____________________________________________________________________________________________________________________ | 5| 5| 6| 7| 7| 1| 6| 7| 7| 7| 6| 6| 7| 7| 7| 3| 6| 6| 6| 7| 4| 4| 4| 4| 4| DAY ON TEST | 7| 9| 4| 3| 3| 9| 4| 0| 3| 3| 3| 4| 1| 3| 3| 6| 1| 3| 9| 3| 6| 6| 6| 6| 6| | 3| 4| 5| 0| 0| 5| 4| 1| 0| 0| 1| 0| 0| 0| 0| 7| 7| 0| 9| 0| 3| 3| 3| 3| 3| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| FISCHER 344 RATS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 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| _____________________________________________________________________________________________________________________| URINARY SYSTEM - cont | | | | | | __________________________________________________________________________| Kidney | + + + + + + + + + + + + + + + + + + + + | Nephropathy, Chronic | 2 2 3 3 2 3 2 2 2 2 3 1 3 3 1 3 3 4 3 | Renal Tubule, Pigmentation | 2 1 2 2 2 2 2 2 2 2 2 1 2 2 2 2 2 2 | __________________________________________________________________________| Urinary Bladder | + + + + + + + + + + + + + + + + + + + + | Mineralization | | _____________________________________________________________________________________________________________________| Page 11 NTP Experiment-Test: 05007-06 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 07:49:23 __________________________________________________________________________________________________________________________________ | 5| 5| 7| 7| 7| 6| 7| 7| 7| 7| | | DAY ON TEST | 6| 7| 3| 3| 3| 4| 1| 3| 3| 3| | | | 1| 5| 0| 0| 0| 5| 0| 0| 0| 0| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | FISCHER 344 RATS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | 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 | + + + + + + + + + + | 49 | __________________________________________________________________________|____________| Intestine Large | + + + + + + + + + + | 50 | __________________________________________________________________________|____________| Intestine Large, Cecum | + + + + + + + + + + | 50 | Inflammation, Acute | | 1 4.0| Parasite Metazoan | | 3 | __________________________________________________________________________|____________| Intestine Large, Colon | + + + + + + + + + + | 50 | Parasite Metazoan | X X X | 5 | __________________________________________________________________________|____________| Intestine Large, Rectum | + + + + + + + + + + | 50 | Parasite Metazoan | | 5 | __________________________________________________________________________|____________| Intestine Small | + + + + + + + + + + | 50 | __________________________________________________________________________|____________| Intestine Small, Duodenum | + + + + + + + + + + | 50 | __________________________________________________________________________|____________| Intestine Small, Ileum | + + + + + + + + + + | 50 | __________________________________________________________________________|____________| Intestine Small, Jejunum | + + + + + + + + + + | 50 | __________________________________________________________________________|____________| Liver | + + + + + + + + + + | 50 | Angiectasis | | 3 2.0| Basophilic Focus | X X X X X X X X X X | 42 | Developmental Malformation | | 5 | Fatty Change | 2 | 6 2.0| Granuloma | 2 | 5 2.2| Hematopoietic Cell Proliferation | 2 2 | 4 1.8| Necrosis | | 2 2.5| Bile Duct, Hyperplasia | 1 1 2 2 1 2 | 23 1.4| Hepatocyte, Hyperplasia | | 2 2.5| Portal, Inflammation, Chronic | 2 1 1 1 1 2 | 15 1.5| __________________________________________________________________________|____________| Mesentery | + + | 10 | Fat, Inflammation, Acute | | 1 4.0| Fat, Necrosis | 4 4 | 7 3.4| __________________________________________________________________________|____________| Pancreas | + + + + + + + + + + | 50 | Acinus, Atrophy | 2 4 2 2 2 | 19 2.1| Acinus, Hyperplasia | 2 | 1 2.0| __________________________________________________________________________|____________| Salivary Glands | + + + + + + + + + + | 50 | Inflammation, Acute | | 2 2.5| Acinus, Atrophy | 2 | 1 2.0| Acinus, Hyperplasia | 2 | 1 2.0| Duct, Ectasia | | 1 3.0| __________________________________________________________________________|____________| Stomach | + + + + + + + + + + | 50 | __________________________________________________________________________|____________| Stomach, Forestomach | + + + + + + + + + + | 50 | Hyperkeratosis | | 1 2.0| Inflammation, Acute | | 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 12 NTP Experiment-Test: 05007-06 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 07:49:23 __________________________________________________________________________________________________________________________________ | 5| 5| 7| 7| 7| 6| 7| 7| 7| 7| | | DAY ON TEST | 6| 7| 3| 3| 3| 4| 1| 3| 3| 3| | | | 1| 5| 0| 0| 0| 5| 0| 0| 0| 0| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | FISCHER 344 RATS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | 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 | | | | | | Inflammation, Chronic | | 1 1.0| Mineralization | | 1 2.0| Ulcer | | 1 3.0| __________________________________________________________________________|____________| Stomach, Glandular | + + + + + + + + + + | 50 | Inflammation, Acute | | 1 3.0| Mineralization | | 3 2.7| Mucosa, Dilatation | 2 2 2 2 2 2 2 1 2 | 41 1.9| __________________________________________________________________________|____________| Tooth | | 1 | Peridontal Tissue, Hemorrhage | | 1 3.0| _____________________________________________________________________________________________________________________| | CARDIOVASCULAR SYSTEM | | | | | | __________________________________________________________________________|____________| Heart | + + + + + + + + + + | 50 | Cardiomyopathy, Chronic | 1 1 2 2 2 2 3 2 2 1 | 44 1.9| Hemorrhage | | 1 2.0| Coronary Artery, Mineralization | | 1 2.0| _____________________________________________________________________________________________________________________| | ENDOCRINE SYSTEM | | | | | | __________________________________________________________________________|____________| Adrenal Gland | + + + + + + + + + + | 50 | __________________________________________________________________________|____________| Adrenal Gland, Cortex | + + + + + + + + + + | 50 | Accessory Adrenal Cortical Nodule | | 1 | Angiectasis | 3 | 1 3.0| Cyst | | 1 | Degeneration, Fatty | 3 2 1 2 2 | 26 1.9| Hematopoietic Cell Proliferation | | 1 2.0| Hyperplasia | 2 | 7 1.6| Hypertrophy | | 4 1.8| Pigmentation | 2 1 1 1 1 1 2 1 | 28 1.2| __________________________________________________________________________|____________| Adrenal Gland, Medulla | + + + + + + + + + + | 50 | Hematopoietic Cell Proliferation | | 1 2.0| Hyperplasia | 2 | 8 1.9| __________________________________________________________________________|____________| Islets, Pancreatic | + + + + + + + + + + | 50 | __________________________________________________________________________|____________| Parathyroid Gland | + M + + + + + + + + | 41 | __________________________________________________________________________|____________| Pituitary Gland | + + + + + + + + + + | 50 | Pars Distalis, Cyst | X | 10 | Pars Distalis, Hyperplasia | | 5 2.2| Pars Distalis, Metaplasia, Osseous | | 1 2.0| Pars Intermedia, Cyst | | 1 | __________________________________________________________________________|____________| Thyroid Gland | + + + + + + + + + + | 50 | C-Cell, Hyperplasia | 2 2 1 1 2 2 1 | 33 1.5| __________________________________________________________________________________________________________________________________ * : 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 13 NTP Experiment-Test: 05007-06 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 07:49:23 __________________________________________________________________________________________________________________________________ | 5| 5| 7| 7| 7| 6| 7| 7| 7| 7| | | DAY ON TEST | 6| 7| 3| 3| 3| 4| 1| 3| 3| 3| | | | 1| 5| 0| 0| 0| 5| 0| 0| 0| 0| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | FISCHER 344 RATS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | 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| | | __________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM | | | | | | None | | | _____________________________________________________________________________________________________________________| | GENITAL SYSTEM | | | | | | __________________________________________________________________________|____________| Clitoral Gland | + + + + + + M + + + | 48 | Abscess | | 1 3.0| Inflammation, Chronic | 2 1 | 10 1.5| Inflammation, Chronic Active | | 6 2.2| Duct, Ectasia | | 5 2.8| __________________________________________________________________________|____________| Ovary | + + + + + + + + + + | 50 | Periovarian Tissue, Cyst | X | 1 | __________________________________________________________________________|____________| Uterus | + + + + + + + + + + | 50 | Ectasia | 2 | 3 2.7| Endometrium, Hyperplasia, Cystic | 2 1 2 | 9 1.9| __________________________________________________________________________|____________| Vagina | | 6 | _____________________________________________________________________________________________________________________| | HEMATOPOIETIC SYSTEM | | | | | | __________________________________________________________________________|____________| Blood | | 2 | __________________________________________________________________________|____________| Bone Marrow | + + + + + + + + + + | 50 | Myelofibrosis | 4 | 1 4.0| __________________________________________________________________________|____________| Lymph Node | + + + + + + + + + + | 50 | Inguinal, Hyperplasia, Lymphoid | | 1 2.0| Mediastinal, Congestion | | 3 3.3| Mediastinal, Hyperplasia, Lymphoid | | 4 2.3| Mediastinal, Hyperplasia, Reticulum | | | Cell | | 1 2.0| Pancreatic, Congestion | 2 | 1 2.0| __________________________________________________________________________|____________| Lymph Node, Mandibular | + + + + + + + + + + | 50 | Hyperplasia, Lymphoid | 2 2 2 2 3 2 2 | 31 2.2| __________________________________________________________________________|____________| Lymph Node, Mesenteric | + + + + + + + + + + | 50 | Congestion | 2 | 2 2.0| Hyperplasia, Lymphoid | 2 3 2 | 16 2.3| Hyperplasia, Reticulum Cell | | 1 2.0| __________________________________________________________________________|____________| Spleen | + + + + + + + + + + | 50 | Hematopoietic Cell Proliferation | 2 2 2 2 3 2 2 2 2 2 | 44 2.2| Hyperplasia, Histiocytic, Lymphoid | 2 | 1 2.0| Hyperplasia, Lymphoid | | 2 2.0| Pigmentation | 3 2 2 2 2 3 2 2 | 37 2.6| Capsule, Fibrosis | | 1 2.0| __________________________________________________________________________|____________| Thymus | + + + + + + + + + + | 47 | __________________________________________________________________________________________________________________________________ * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 14 NTP Experiment-Test: 05007-06 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 07:49:23 __________________________________________________________________________________________________________________________________ | 5| 5| 7| 7| 7| 6| 7| 7| 7| 7| | | DAY ON TEST | 6| 7| 3| 3| 3| 4| 1| 3| 3| 3| | | | 1| 5| 0| 0| 0| 5| 0| 0| 0| 0| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | FISCHER 344 RATS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | 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 | | | | | | Cyst | X | 2 | Hemorrhage | | 1 4.0| Hyperplasia, Lymphoid | 3 | 3 2.3| _____________________________________________________________________________________________________________________| | INTEGUMENTARY SYSTEM | | | | | | __________________________________________________________________________|____________| Mammary Gland | + + + + + + + + + + | 50 | Acinus, Ectasia | 4 3 2 4 3 2 4 2 2 | 45 3.0| Acinus, Hyperplasia | 2 | 4 2.8| Duct, Ectasia | 2 2 4 | 12 2.9| __________________________________________________________________________|____________| Skin | + + + + + + + + + + | 50 | Cyst Epithelial Inclusion | | 3 | Inflammation, Chronic Active | | 2 2.0| Inflammation, Suppurative | | 2 2.5| _____________________________________________________________________________________________________________________| | MUSCULOSKELETAL SYSTEM | | | | | | __________________________________________________________________________|____________| Bone | + + + + + + + + + + | 50 | Cranium, Fibrous Osteodystrophy | | 1 4.0| Cranium, Osteopetrosis | | 5 3.4| Femur, Fibrous Osteodystrophy | | 1 4.0| Femur, Osteopetrosis | | 1 3.0| Rib, Hyperplasia | | 1 2.0| __________________________________________________________________________|____________| Skeletal Muscle | | 1 | _____________________________________________________________________________________________________________________| | NERVOUS SYSTEM | | | | | | __________________________________________________________________________|____________| Brain | + + + + + + + + + + | 50 | Compression | X X X X X | 19 | Hemorrhage | | 1 3.0| _____________________________________________________________________________________________________________________| | RESPIRATORY SYSTEM | | | | | | __________________________________________________________________________|____________| Lung | + + + + + + + + + + | 50 | Congestion | | 1 2.0| Hemorrhage | 1 1 2 | 13 1.5| Alveolar Epithelium, Hyperplasia | | 1 2.0| Alveolus, Infiltration Cellular, | | | Histiocyte | 1 2 2 2 1 | 28 1.7| Arteriole, Mineralization | 2 2 2 2 2 2 | 27 1.9| Interstitium, Inflammation, Chronic | 2 | 1 2.0| __________________________________________________________________________|____________| Nose | + + + + + + + + + + | 50 | Lumen, Hemorrhage | 1 2 2 1 | 22 1.5| __________________________________________________________________________________________________________________________________ * : 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 15 NTP Experiment-Test: 05007-06 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 07:49:23 __________________________________________________________________________________________________________________________________ | 5| 5| 7| 7| 7| 6| 7| 7| 7| 7| | | DAY ON TEST | 6| 7| 3| 3| 3| 4| 1| 3| 3| 3| | | | 1| 5| 0| 0| 0| 5| 0| 0| 0| 0| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | FISCHER 344 RATS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | 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 | | | | | | Mucosa, Cyst | | 1 | Mucosa, Inflammation, Acute | | 3 3.0| Nasolacrimal Duct, Hemorrhage | | 1 2.0| Nasolacrimal Duct, Inflammation, | | | Acute | 2 3 2 | 14 2.0| Olfactory Epithelium, Degeneration | 2 2 2 2 2 2 2 2 2 1 | 46 2.0| Respiratory Epithelium, Degeneration | 2 3 2 2 1 2 2 | 30 1.7| Vomeronasal Organ, Inflammation, | | | Acute | | 1 2.0| __________________________________________________________________________|____________| Trachea | + + + + + + + + + + | 50 | _____________________________________________________________________________________________________________________| | SPECIAL SENSES SYSTEM | | | | | | __________________________________________________________________________|____________| Eye | + + + | 6 | Cataract | 4 2 4 | 5 3.2| Hemorrhage | 3 | 1 3.0| Synechia | 4 | 1 4.0| Retina, Degeneration | 4 3 4 | 6 3.8| _____________________________________________________________________________________________________________________| | URINARY SYSTEM | | | | | | __________________________________________________________________________|____________| Kidney | + + + + + + + + + + | 50 | Nephropathy, Chronic | 3 1 4 2 3 3 3 2 3 2 | 48 2.5| Renal Tubule, Pigmentation | 1 1 2 2 2 2 2 2 2 1 | 47 1.9| __________________________________________________________________________|____________| Urinary Bladder | + + + + + + + + + + | 50 | Mineralization | | 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 16 NTP Experiment-Test: 05007-06 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 07:49:23 _____________________________________________________________________________________________________________________ | 6| 7| 7| 7| 7| 7| 7| 7| 7| 7| 6| 7| 7| 7| 7| 4| 4| 4| 4| 4| 6| 7| 7| 7| 7| DAY ON TEST | 1| 0| 3| 3| 3| 3| 3| 3| 3| 3| 1| 3| 3| 3| 3| 6| 6| 6| 6| 6| 1| 3| 3| 3| 3| | 0| 2| 0| 0| 1| 1| 1| 1| 1| 1| 0| 1| 1| 1| 1| 3| 3| 3| 3| 3| 2| 1| 1| 1| 1| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| FISCHER 344 RATS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 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 | + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Large | + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Large, Cecum | + + + + + + + + + + + + + + + + + + + +| Mineralization | | Parasite Metazoan | | __________________________________________________________________________| Intestine Large, Colon | + + + + + + + + + + + + + + + + + + + +| Mineralization | | Parasite Metazoan | X X | __________________________________________________________________________| Intestine Large, Rectum | + + + + M + + + + + + + + + + + + + + +| Parasite Metazoan | X X X X | __________________________________________________________________________| Intestine Small | + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Small, Duodenum | + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Small, Ileum | + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Small, Jejunum | + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Liver | + + + + + + + + + + + + + + + + + + + +| Angiectasis | 2 | Basophilic Focus | X X X X X X X X X X X X X X X X X X X| Developmental Malformation | X X X X X X | Fatty Change | 2 | Granuloma | 2 2 2 | Hematopoietic Cell Proliferation | 2 | Mineralization | | Bile Duct, Hyperplasia | 1 2 1 1 2 1 1 1 2 2 1 | Portal, Inflammation, Chronic | 1 2 1 1 1 1| __________________________________________________________________________| Mesentery | + | Fat, Necrosis | 3 | __________________________________________________________________________| Pancreas | + + + + + + + + + + + + + + + + + + + +| Acinus, Atrophy | 2 4 2 1 1 2 2 2 2 1 | Acinus, Hyperplasia | 2 | __________________________________________________________________________| Salivary Glands | + + + + + + + + + + + + + + + + + + + +| Duct, Hyperplasia | 2 | __________________________________________________________________________| Stomach | + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Stomach, Forestomach | + + + + + + + + + + + + + + + + + + + +| Inflammation, Chronic | | Mineralization | | __________________________________________________________________________| Stomach, Glandular | + + + + + + + + + + + + + + + + + + + +| Inflammation, Chronic Active | | Mineralization | 2 2 2 1| Mucosa, Dilatation | 2 2 2 2 2 1 2 2 2 2 2 2 2| Mucosa, Ulcer | | __________________________________________________________________________| Tooth | | _____________________________________________________________________________________________________________________| CARDIOVASCULAR SYSTEM | | | | __________________________________________________________________________| Heart | + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| Page 17 NTP Experiment-Test: 05007-06 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 07:49:23 _____________________________________________________________________________________________________________________ | 6| 7| 7| 7| 7| 7| 7| 7| 7| 7| 6| 7| 7| 7| 7| 4| 4| 4| 4| 4| 6| 7| 7| 7| 7| DAY ON TEST | 1| 0| 3| 3| 3| 3| 3| 3| 3| 3| 1| 3| 3| 3| 3| 6| 6| 6| 6| 6| 1| 3| 3| 3| 3| | 0| 2| 0| 0| 1| 1| 1| 1| 1| 1| 0| 1| 1| 1| 1| 3| 3| 3| 3| 3| 2| 1| 1| 1| 1| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| FISCHER 344 RATS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 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| _____________________________________________________________________________________________________________________| CARDIOVASCULAR SYSTEM - cont | | | | Cardiomyopathy, Chronic | 1 1 2 2 1 2 2 3 2 2 2 1 1 3 3 2 2 1 2| Mineralization | | Coronary Artery, Mineralization | | _____________________________________________________________________________________________________________________| ENDOCRINE SYSTEM | | | | __________________________________________________________________________| Adrenal Gland | + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Adrenal Gland, Cortex | + + + + + + + + + + + + + + + + + + + +| Degeneration, Fatty | 1 3 2 2 1 2 2 2 1 2 | Hyperplasia | 2 2 1 2 2 2 2 2 | Hypertrophy | 2 1 | Mineralization | | Pigmentation | 1 1 1 1 1 1 1 1 1 1 1 1 1 | __________________________________________________________________________| Adrenal Gland, Medulla | + + + + + + + + + + + + + + + + + + + +| Hyperplasia | 2 2 | __________________________________________________________________________| Islets, Pancreatic | + + + + + + + + + + + + + + + + + + + +| Hyperplasia | | __________________________________________________________________________| Parathyroid Gland | + + + + M + M + + M + + M + + M + + M +| Hyperplasia | | __________________________________________________________________________| Pituitary Gland | + + + + + + + + + + + + + + + + + + + +| Pars Distalis, Angiectasis | 3 | Pars Distalis, Cyst | X X X X X X X | Pars Distalis, Hyperplasia | 3 1 2 1 2 | Pars Intermedia, Cyst | X | __________________________________________________________________________| Thyroid Gland | + + + + + + + + + + + + + + + + + + + +| Ultimobranchial Cyst | X | C-Cell, Hyperplasia | 3 2 2 2 1 2 3 2 2 1 1 | _____________________________________________________________________________________________________________________| GENERAL BODY SYSTEM | | | | None | | _____________________________________________________________________________________________________________________| GENITAL SYSTEM | | | | __________________________________________________________________________| Clitoral Gland | + + + + + + + + + + + + + + + + + + + +| Abscess | | Cyst | | Inflammation, Chronic | 3 1 1 | Inflammation, Chronic Active | 4 | Duct, Ectasia | | Duct, Hyperplasia | | __________________________________________________________________________| Ovary | + + + + + + + + + + + + + + + + + + + +| Hyperplasia, Adenomatous | | Follicle, Cyst | | __________________________________________________________________________| Uterus | + + + + + + + + + + + + + + + + + + + +| Ectasia | 2 | Hemorrhage | 3 | _____________________________________________________________________________________________________________________| Page 18 NTP Experiment-Test: 05007-06 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 07:49:23 _____________________________________________________________________________________________________________________ | 6| 7| 7| 7| 7| 7| 7| 7| 7| 7| 6| 7| 7| 7| 7| 4| 4| 4| 4| 4| 6| 7| 7| 7| 7| DAY ON TEST | 1| 0| 3| 3| 3| 3| 3| 3| 3| 3| 1| 3| 3| 3| 3| 6| 6| 6| 6| 6| 1| 3| 3| 3| 3| | 0| 2| 0| 0| 1| 1| 1| 1| 1| 1| 0| 1| 1| 1| 1| 3| 3| 3| 3| 3| 2| 1| 1| 1| 1| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| FISCHER 344 RATS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 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 | | | | Inflammation, Acute | | Endometrium, Hyperplasia, Cystic | 3 2 2 3 2 | __________________________________________________________________________| Vagina | + | Inflammation, Acute | | _____________________________________________________________________________________________________________________| HEMATOPOIETIC SYSTEM | | | | __________________________________________________________________________| Bone Marrow | + + + + + + + + + + + + + + + + + + + +| Hemorrhage | 3 | Myelofibrosis | 4 | __________________________________________________________________________| Lymph Node | + + + + + + + + + + + + + + + + + + + +| Mediastinal, Congestion | 2 3 2| Mediastinal, Hyperplasia, Lymphoid | 2 | Mediastinal, Pigmentation | 2| __________________________________________________________________________| Lymph Node, Mandibular | + + + + + + + + + + + + + + + + + + + +| Congestion | | Cyst | | Hyperplasia, Lymphoid | 2 2 2 2 2 3 2 2 2 2 2 2| __________________________________________________________________________| Lymph Node, Mesenteric | + + + + + + + + + + + + + + + + + + + +| Hyperplasia, Lymphoid | 2 2 2 2 2 3 3 | __________________________________________________________________________| Spleen | + + + + + + + + + + + + + + + + + + + +| Hematopoietic Cell Proliferation | 2 1 2 2 3 2 2 2 1 2 2 2 2 2 3 2 2 2| Hyperplasia, Histiocytic, Lymphoid | 4 | Infarct | | Pigmentation | 3 2 3 2 2 2 2 3 2 3 2 3 2 2 2 2 3| Capsule, Inflammation, Chronic | 2 | __________________________________________________________________________| Thymus | + + + + + + + + + + + + M + + + + + + +| Congestion | 4 | Cyst | X | Hyperplasia, Lymphoid | 2 | _____________________________________________________________________________________________________________________| INTEGUMENTARY SYSTEM | | | | __________________________________________________________________________| Mammary Gland | + + + + + + + + + + + + + + + + + + + +| Inflammation, Acute | 2 | Acinus, Ectasia | 2 2 2 2 3 4 2 2 4 4 3 2| Acinus, Hyperplasia | 2 | Duct, Ectasia | 2 2 4 2 2| __________________________________________________________________________| Skin | + + + + + + + + + + + + + + + + + + + +| Cyst Epithelial Inclusion | | _____________________________________________________________________________________________________________________| MUSCULOSKELETAL SYSTEM | | | | __________________________________________________________________________| Bone | + + + + + + + + + + + + + + + + + + + +| Cranium, Inflammation, Chronic | | Cranium, Osteopetrosis | 3 | __________________________________________________________________________| Skeletal Muscle | | _____________________________________________________________________________________________________________________| Page 19 NTP Experiment-Test: 05007-06 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 07:49:23 _____________________________________________________________________________________________________________________ | 6| 7| 7| 7| 7| 7| 7| 7| 7| 7| 6| 7| 7| 7| 7| 4| 4| 4| 4| 4| 6| 7| 7| 7| 7| DAY ON TEST | 1| 0| 3| 3| 3| 3| 3| 3| 3| 3| 1| 3| 3| 3| 3| 6| 6| 6| 6| 6| 1| 3| 3| 3| 3| | 0| 2| 0| 0| 1| 1| 1| 1| 1| 1| 0| 1| 1| 1| 1| 3| 3| 3| 3| 3| 2| 1| 1| 1| 1| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| FISCHER 344 RATS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 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| _____________________________________________________________________________________________________________________| MUSCULOSKELETAL SYSTEM - cont | | | | _____________________________________________________________________________________________________________________| NERVOUS SYSTEM | | | | __________________________________________________________________________| Brain | + + + + + + + + + + + + + + + + + + + +| Compression | X X X| Hemorrhage | 2| __________________________________________________________________________| Spinal Cord | | _____________________________________________________________________________________________________________________| RESPIRATORY SYSTEM | | | | __________________________________________________________________________| Lung | + + + + + + + + + + + + + + + + + + + +| Congestion | 2 2 2 2| Hemorrhage | 1 2 2 1 1 1 1| Alveolar Epithelium, Hyperplasia | | Alveolus, Infiltration Cellular, | | Histiocyte | 1 2 2 2 1 2 2 1 2 2 2 | Arteriole, Mineralization | 2 2 2 2 2 2 2 2 2 2 2 2 2 2| Interstitium, Inflammation, Chronic | 1 1 | Peribronchiolar, Inflammation, Acute | | __________________________________________________________________________| Nose | + + + + + + + + + + + + + + + + + + + +| Lumen, Hemorrhage | 2 1 2 2 2 2 1 2| Mucosa, Inflammation, Acute | | Nasolacrimal Duct, Inflammation, | | Acute | 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 | 1 2 1 2 1 2 1 2 1 1 2 2 3 | __________________________________________________________________________| Trachea | + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| SPECIAL SENSES SYSTEM | | | | __________________________________________________________________________| Eye | + + + + | Cataract | 3 4 4 2 | Hemorrhage | 4 | Synechia | 3 3 | Retina, Degeneration | 4 4 4 4 | Sclera, Mineralization | 2 | __________________________________________________________________________| Zymbal's Gland | | _____________________________________________________________________________________________________________________| URINARY SYSTEM | | | | __________________________________________________________________________| Kidney | + + + + + + + + + + + + + + + + + + + +| Cyst | X X X | Mineralization | | Nephropathy, Chronic | 2 2 2 2 2 2 3 3 3 3 2 1 2 2 3 2 3 3 3 1| Pelvis, Inflammation, Acute | | Pelvis, Necrosis | | Renal Tubule, Pigmentation | 1 1 2 1 2 2 2 2 2 1 1 1 1 2 2 1 2 2 2 2| __________________________________________________________________________| Urinary Bladder | + + + + + + + + + + + + + + + + + + + +| Hemorrhage | | _____________________________________________________________________________________________________________________| Page 20 NTP Experiment-Test: 05007-06 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 07:49:23 _____________________________________________________________________________________________________________________ | 5| 6| 7| 7| 7| 5| 6| 6| 7| 7| 5| 6| 6| 7| 7| 4| 4| 4| 4| 4| 3| 4| 6| 6| 7| DAY ON TEST | 3| 3| 0| 0| 3| 6| 9| 9| 3| 3| 7| 1| 4| 1| 3| 6| 6| 6| 6| 6| 1| 3| 3| 4| 3| | 5| 3| 0| 8| 1| 7| 4| 9| 1| 1| 1| 2| 0| 7| 1| 3| 3| 3| 3| 3| 6| 2| 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| FISCHER 344 RATS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 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 | + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Large | + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Large, Cecum | + + + + + + + + + + + + + + + + I + + +| Mineralization | | Parasite Metazoan | X X | __________________________________________________________________________| Intestine Large, Colon | + + + + + + + + + + + + + + + + + + + +| Mineralization | | Parasite Metazoan | X X X X | __________________________________________________________________________| Intestine Large, Rectum | + + + + + + + + + + + + + + + + I + + +| Parasite Metazoan | X X X | __________________________________________________________________________| Intestine Small | + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Small, Duodenum | + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Small, Ileum | + + + + + + + + + + + + + + + A + + + +| __________________________________________________________________________| Intestine Small, Jejunum | + + + + + + + + + + + + + + + A + + + +| __________________________________________________________________________| Liver | + + + + + + + + + + + + + + + + + + + +| Angiectasis | | Basophilic Focus | X X X X X X X X X X X X X X X X| Developmental Malformation | X X X | Fatty Change | 1 1 2 1 | Granuloma | 2 2 2 | Hematopoietic Cell Proliferation | 2 | Mineralization | | Bile Duct, Hyperplasia | 2 1 3 1 1 1 1 1 2 1 1| Portal, Inflammation, Chronic | 2 1 3 1 1 1 1| __________________________________________________________________________| Mesentery | + | Fat, Necrosis | 4 | __________________________________________________________________________| Pancreas | + + + + + + + + + + + + + + + + + + + +| Acinus, Atrophy | 1 1 2 1 2 2 | Acinus, Hyperplasia | | __________________________________________________________________________| Salivary Glands | + + + + + + + + + + + + + + + + + + + +| Duct, Hyperplasia | | __________________________________________________________________________| Stomach | + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Stomach, Forestomach | + + + + + + + + + + + + + + + + + + + +| Inflammation, Chronic | 2 | Mineralization | 2 | __________________________________________________________________________| Stomach, Glandular | + + + + + + + + + + + + + + + + + + + +| Inflammation, Chronic Active | | Mineralization | 2 2 3 | Mucosa, Dilatation | 2 2 2 2 1 2 2 2 1 2 2| Mucosa, Ulcer | 3 | __________________________________________________________________________| Tooth | | _____________________________________________________________________________________________________________________| CARDIOVASCULAR SYSTEM | | | | __________________________________________________________________________| Heart | + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| Page 21 NTP Experiment-Test: 05007-06 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 07:49:23 _____________________________________________________________________________________________________________________ | 5| 6| 7| 7| 7| 5| 6| 6| 7| 7| 5| 6| 6| 7| 7| 4| 4| 4| 4| 4| 3| 4| 6| 6| 7| DAY ON TEST | 3| 3| 0| 0| 3| 6| 9| 9| 3| 3| 7| 1| 4| 1| 3| 6| 6| 6| 6| 6| 1| 3| 3| 4| 3| | 5| 3| 0| 8| 1| 7| 4| 9| 1| 1| 1| 2| 0| 7| 1| 3| 3| 3| 3| 3| 6| 2| 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| FISCHER 344 RATS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 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| _____________________________________________________________________________________________________________________| CARDIOVASCULAR SYSTEM - cont | | | | Cardiomyopathy, Chronic | 1 1 2 2 3 2 1 2 1 3 1 1 1 1 1 2 3| Mineralization | 2 | Coronary Artery, Mineralization | 2 | _____________________________________________________________________________________________________________________| ENDOCRINE SYSTEM | | | | __________________________________________________________________________| Adrenal Gland | + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Adrenal Gland, Cortex | + + + + + + + + + + + + + + + + + + + +| Degeneration, Fatty | 1 2 2 1 3 1 3 1 2| Hyperplasia | 2| Hypertrophy | 2 1 | Mineralization | 2 | Pigmentation | 1 1 1 2 1 1 1 1 1 2 1 1 1| __________________________________________________________________________| Adrenal Gland, Medulla | + + + + + + + + + + + + + + + + + + + +| Hyperplasia | 2 2 2| __________________________________________________________________________| Islets, Pancreatic | + + + + + + + + + + + + + + + + + + + +| Hyperplasia | 2 | __________________________________________________________________________| Parathyroid Gland | + + + + + M + + + + + + + + + M + + + +| Hyperplasia | | __________________________________________________________________________| Pituitary Gland | + + + + + + + + + + + + + + + + + + + +| Pars Distalis, Angiectasis | | Pars Distalis, Cyst | X X X X X X| Pars Distalis, Hyperplasia | 2 2 | Pars Intermedia, Cyst | X | __________________________________________________________________________| Thyroid Gland | + + + + + + + + + + + + + + + + + + + +| Ultimobranchial Cyst | X | C-Cell, Hyperplasia | 2 1 1 2 2 1 1 1 2 2 2| _____________________________________________________________________________________________________________________| GENERAL BODY SYSTEM | | | | None | | _____________________________________________________________________________________________________________________| GENITAL SYSTEM | | | | __________________________________________________________________________| Clitoral Gland | + + + + + + + + + + + + + + + + + + + +| Abscess | 4 | Cyst | | Inflammation, Chronic | 2 2 2 | Inflammation, Chronic Active | 2 3 | Duct, Ectasia | 3 | Duct, Hyperplasia | 2 | __________________________________________________________________________| Ovary | + + + + + + + + + + + + + + + + + + + +| Hyperplasia, Adenomatous | | Follicle, Cyst | | __________________________________________________________________________| Uterus | + + + + + + + + + + + + + + + + + + + +| Ectasia | | Hemorrhage | | _____________________________________________________________________________________________________________________| Page 22 NTP Experiment-Test: 05007-06 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 07:49:23 _____________________________________________________________________________________________________________________ | 5| 6| 7| 7| 7| 5| 6| 6| 7| 7| 5| 6| 6| 7| 7| 4| 4| 4| 4| 4| 3| 4| 6| 6| 7| DAY ON TEST | 3| 3| 0| 0| 3| 6| 9| 9| 3| 3| 7| 1| 4| 1| 3| 6| 6| 6| 6| 6| 1| 3| 3| 4| 3| | 5| 3| 0| 8| 1| 7| 4| 9| 1| 1| 1| 2| 0| 7| 1| 3| 3| 3| 3| 3| 6| 2| 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| FISCHER 344 RATS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 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 | | | | Inflammation, Acute | 4 | Endometrium, Hyperplasia, Cystic | 2 2 2 3 2 | __________________________________________________________________________| Vagina | + + + + | Inflammation, Acute | 2 | _____________________________________________________________________________________________________________________| HEMATOPOIETIC SYSTEM | | | | __________________________________________________________________________| Bone Marrow | + + + + + + + + + + + + + + + + + + + +| Hemorrhage | | Myelofibrosis | | __________________________________________________________________________| Lymph Node | + + + + + + + + + + + + + + + + + + + +| Mediastinal, Congestion | | Mediastinal, Hyperplasia, Lymphoid | 3 | Mediastinal, Pigmentation | | __________________________________________________________________________| Lymph Node, Mandibular | + + + + + + + + + + + + + + + + + + + +| Congestion | 2 3 | Cyst | | Hyperplasia, Lymphoid | 2 2 2 2 2 3 2 2 2 | __________________________________________________________________________| Lymph Node, Mesenteric | + + + + + + + + + + + + + + + + + + + +| Hyperplasia, Lymphoid | 2 3 2| __________________________________________________________________________| Spleen | + + + + + + + + + + + + + + + + + + + +| Hematopoietic Cell Proliferation | 2 2 2 2 2 2 2 2 2 2 2 2 2 2| Hyperplasia, Histiocytic, Lymphoid | | Infarct | 4 | Pigmentation | 2 3 2 2 3 3 3 2 3 2 2 2 3 3 2 2 2| Capsule, Inflammation, Chronic | | __________________________________________________________________________| Thymus | + + + + + + + + + M + + + + + + I + + +| Congestion | 2 2 | Cyst | X X | Hyperplasia, Lymphoid | 2 2 2 2 | _____________________________________________________________________________________________________________________| INTEGUMENTARY SYSTEM | | | | __________________________________________________________________________| Mammary Gland | + + + + + + + + + + + + + + + + + + + +| Inflammation, Acute | | Acinus, Ectasia | 3 3 3 2 2 3 3 2 4 2 3 3 4 2 2| Acinus, Hyperplasia | | Duct, Ectasia | 2 3 4 3 3 3 3 4 2 3 2 2| __________________________________________________________________________| Skin | + + + + + + + + + + + + + + + + + + + +| Cyst Epithelial Inclusion | X | _____________________________________________________________________________________________________________________| MUSCULOSKELETAL SYSTEM | | | | __________________________________________________________________________| Bone | + + + + + + + + + + + + + + + + + + + +| Cranium, Inflammation, Chronic | | Cranium, Osteopetrosis | 3 3 | __________________________________________________________________________| Skeletal Muscle | + | _____________________________________________________________________________________________________________________| Page 23 NTP Experiment-Test: 05007-06 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 07:49:23 _____________________________________________________________________________________________________________________ | 5| 6| 7| 7| 7| 5| 6| 6| 7| 7| 5| 6| 6| 7| 7| 4| 4| 4| 4| 4| 3| 4| 6| 6| 7| DAY ON TEST | 3| 3| 0| 0| 3| 6| 9| 9| 3| 3| 7| 1| 4| 1| 3| 6| 6| 6| 6| 6| 1| 3| 3| 4| 3| | 5| 3| 0| 8| 1| 7| 4| 9| 1| 1| 1| 2| 0| 7| 1| 3| 3| 3| 3| 3| 6| 2| 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| FISCHER 344 RATS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 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| _____________________________________________________________________________________________________________________| MUSCULOSKELETAL SYSTEM - cont | | | | _____________________________________________________________________________________________________________________| NERVOUS SYSTEM | | | | __________________________________________________________________________| Brain | + + + + + + + + + + + + + + + + + + + +| Compression | X X X X | Hemorrhage | | __________________________________________________________________________| Spinal Cord | | _____________________________________________________________________________________________________________________| RESPIRATORY SYSTEM | | | | __________________________________________________________________________| Lung | + + + + + + + + + + + + + + + + + + + +| Congestion | 2 4 3 4 3 | Hemorrhage | 1 1 1 | Alveolar Epithelium, Hyperplasia | 2 | Alveolus, Infiltration Cellular, | | Histiocyte | 3 2 2 2 2 2 | Arteriole, Mineralization | 2 2 2 2 2 2 2 2 2 2 2 1| Interstitium, Inflammation, Chronic | | Peribronchiolar, Inflammation, Acute | 4 | __________________________________________________________________________| Nose | + + + + + + + + + + + + + + + + + + + +| Lumen, Hemorrhage | 2 2 1 2 2 1 1 1 2 2 1| Mucosa, Inflammation, Acute | 1 1 | Nasolacrimal Duct, Inflammation, | | Acute | 2 2 2 1 1 3 | Olfactory Epithelium, Degeneration | 1 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2| Respiratory Epithelium, Degeneration | 1 3 1 2 2 1 1 | __________________________________________________________________________| Trachea | + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| SPECIAL SENSES SYSTEM | | | | __________________________________________________________________________| Eye | + + + +| Cataract | 4 4 4 4| Hemorrhage | 4 | Synechia | 4 | Retina, Degeneration | 4 4 4 4| Sclera, Mineralization | | __________________________________________________________________________| Zymbal's Gland | + | _____________________________________________________________________________________________________________________| URINARY SYSTEM | | | | __________________________________________________________________________| Kidney | + + + + + + + + + + + + + + + + + + + +| Cyst | | Mineralization | 3 | Nephropathy, Chronic | 2 2 2 2 2 1 1 2 2 2 2 2 2 3 1 1 2 3| Pelvis, Inflammation, Acute | 2 4 | Pelvis, Necrosis | 4 | Renal Tubule, Pigmentation | 2 2 2 2 1 2 2 2 1 2 1 2 2 1 2| __________________________________________________________________________| Urinary Bladder | + + + + + + + + + + + + + + + + + + + +| Hemorrhage | 2 | _____________________________________________________________________________________________________________________| Page 24 NTP Experiment-Test: 05007-06 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 07:49:23 __________________________________________________________________________________________________________________________________ | 5| 6| 7| 7| 7| 6| 6| 6| 7| 7| | | DAY ON TEST | 6| 1| 3| 3| 3| 2| 9| 9| 1| 3| | | | 8| 9| 1| 1| 1| 3| 4| 8| 6| 1| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | FISCHER 344 RATS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | 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 | + + + + + + + + + + | 50 | __________________________________________________________________________|____________| Intestine Large | + + + + + + + + + + | 50 | __________________________________________________________________________|____________| Intestine Large, Cecum | + + + + + + + + + + | 49 | Mineralization | 2 | 1 2.0| Parasite Metazoan | | 2 | __________________________________________________________________________|____________| Intestine Large, Colon | + + + + + + + + + + | 50 | Mineralization | 2 | 1 2.0| Parasite Metazoan | X | 7 | __________________________________________________________________________|____________| Intestine Large, Rectum | + + + + + + + + + + | 48 | Parasite Metazoan | | 7 | __________________________________________________________________________|____________| Intestine Small | + + + + + + + + + + | 50 | __________________________________________________________________________|____________| Intestine Small, Duodenum | + + + + + + + + + + | 50 | __________________________________________________________________________|____________| Intestine Small, Ileum | + + + + + + + + + + | 49 | __________________________________________________________________________|____________| Intestine Small, Jejunum | + + + + + + + + + + | 49 | __________________________________________________________________________|____________| Liver | + + + + + + + + + + | 50 | Angiectasis | | 1 2.0| Basophilic Focus | X X X X X X X X | 43 | Developmental Malformation | X | 10 | Fatty Change | 3 2 1 | 8 1.6| Granuloma | 2 2 | 8 2.0| Hematopoietic Cell Proliferation | | 2 2.0| Mineralization | 2 | 1 2.0| Bile Duct, Hyperplasia | 1 1 1 1 1 2 | 28 1.3| Portal, Inflammation, Chronic | 2 1 1 | 16 1.3| __________________________________________________________________________|____________| Mesentery | + | 3 | Fat, Necrosis | 3 | 3 3.3| __________________________________________________________________________|____________| Pancreas | + + + + + + + + + + | 50 | Acinus, Atrophy | 1 2 2 1 | 20 1.7| Acinus, Hyperplasia | | 1 2.0| __________________________________________________________________________|____________| Salivary Glands | + + + + + + + + + + | 50 | Duct, Hyperplasia | | 1 2.0| __________________________________________________________________________|____________| Stomach | + + + + + + + + + + | 50 | __________________________________________________________________________|____________| Stomach, Forestomach | + + + + + + + + + + | 50 | Inflammation, Chronic | 3 | 2 2.5| Mineralization | 4 | 2 3.0| __________________________________________________________________________|____________| Stomach, Glandular | + + + + + + + + + + | 50 | Inflammation, Chronic Active | 3 | 1 3.0| Mineralization | 4 | 8 2.3| Mucosa, Dilatation | 2 2 2 2 2 2 2 | 31 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 25 NTP Experiment-Test: 05007-06 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 07:49:23 __________________________________________________________________________________________________________________________________ | 5| 6| 7| 7| 7| 6| 6| 6| 7| 7| | | DAY ON TEST | 6| 1| 3| 3| 3| 2| 9| 9| 1| 3| | | | 8| 9| 1| 1| 1| 3| 4| 8| 6| 1| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | FISCHER 344 RATS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | 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 | | | | | | Mucosa, Ulcer | | 1 3.0| __________________________________________________________________________|____________| Tooth | + | 1 | _____________________________________________________________________________________________________________________| | CARDIOVASCULAR SYSTEM | | | | | | __________________________________________________________________________|____________| Heart | + + + + + + + + + + | 50 | Cardiomyopathy, Chronic | 1 2 2 2 2 2 2 2 1 | 45 1.8| Mineralization | | 1 2.0| Coronary Artery, Mineralization | | 1 2.0| _____________________________________________________________________________________________________________________| | ENDOCRINE SYSTEM | | | | | | __________________________________________________________________________|____________| Adrenal Gland | + + + + + + + + + + | 50 | __________________________________________________________________________|____________| Adrenal Gland, Cortex | + + + + + + + + + + | 50 | Degeneration, Fatty | 2 2 3 2 | 23 1.9| Hyperplasia | | 9 1.9| Hypertrophy | | 4 1.5| Mineralization | | 1 2.0| Pigmentation | 1 1 1 1 1 1 | 32 1.1| __________________________________________________________________________|____________| Adrenal Gland, Medulla | + + + + + + + + + + | 50 | Hyperplasia | 2 | 6 2.0| __________________________________________________________________________|____________| Islets, Pancreatic | + + + + + + + + + + | 50 | Hyperplasia | | 1 2.0| __________________________________________________________________________|____________| Parathyroid Gland | + + + + + + + M + + | 41 | Hyperplasia | 2 | 1 2.0| __________________________________________________________________________|____________| Pituitary Gland | + + + + + + + + + + | 50 | Pars Distalis, Angiectasis | | 1 3.0| Pars Distalis, Cyst | X X | 15 | Pars Distalis, Hyperplasia | | 7 1.9| Pars Intermedia, Cyst | | 2 | __________________________________________________________________________|____________| Thyroid Gland | + + + + + + + + + + | 50 | Ultimobranchial Cyst | | 2 | C-Cell, Hyperplasia | 1 2 2 1 1 2 2 2 | 30 1.7| _____________________________________________________________________________________________________________________| | GENERAL BODY SYSTEM | | | | | | None | | | _____________________________________________________________________________________________________________________| | GENITAL SYSTEM | | | | | | __________________________________________________________________________|____________| Clitoral Gland | + + + + + + + + + + | 50 | Abscess | | 1 4.0| Cyst | X | 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 26 NTP Experiment-Test: 05007-06 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 07:49:23 __________________________________________________________________________________________________________________________________ | 5| 6| 7| 7| 7| 6| 6| 6| 7| 7| | | DAY ON TEST | 6| 1| 3| 3| 3| 2| 9| 9| 1| 3| | | | 8| 9| 1| 1| 1| 3| 4| 8| 6| 1| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | FISCHER 344 RATS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | 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 - cont | | | | | | Inflammation, Chronic | 2 1 1 | 9 1.7| Inflammation, Chronic Active | | 3 3.0| Duct, Ectasia | | 1 3.0| Duct, Hyperplasia | | 1 2.0| __________________________________________________________________________|____________| Ovary | + + + + + + + + + + | 50 | Hyperplasia, Adenomatous | 2 | 1 2.0| Follicle, Cyst | X | 1 | __________________________________________________________________________|____________| Uterus | + + + + + + + + + + | 50 | Ectasia | 2 | 2 2.0| Hemorrhage | 4 4 | 3 3.7| Inflammation, Acute | | 1 4.0| Endometrium, Hyperplasia, Cystic | 2 2 2 | 13 2.2| __________________________________________________________________________|____________| Vagina | | 5 | Inflammation, Acute | | 1 2.0| _____________________________________________________________________________________________________________________| | HEMATOPOIETIC SYSTEM | | | | | | __________________________________________________________________________|____________| Bone Marrow | + + + + + + + + + + | 50 | Hemorrhage | | 1 3.0| Myelofibrosis | | 1 4.0| __________________________________________________________________________|____________| Lymph Node | + + + + + + + + + + | 50 | Mediastinal, Congestion | 2 3 | 5 2.4| Mediastinal, Hyperplasia, Lymphoid | | 2 2.5| Mediastinal, Pigmentation | | 1 2.0| __________________________________________________________________________|____________| Lymph Node, Mandibular | + + + + + + + + + + | 50 | Congestion | | 2 2.5| Cyst | X | 1 | Hyperplasia, Lymphoid | 2 2 3 3 | 25 2.2| __________________________________________________________________________|____________| Lymph Node, Mesenteric | + + + + + + + + + + | 50 | Hyperplasia, Lymphoid | 2 2 | 12 2.3| __________________________________________________________________________|____________| Spleen | + + + + + + + + + + | 50 | Hematopoietic Cell Proliferation | 2 2 2 2 3 2 2 | 39 2.0| Hyperplasia, Histiocytic, Lymphoid | | 1 4.0| Infarct | | 1 4.0| Pigmentation | 3 2 3 3 2 4 2 2 | 42 2.4| Capsule, Inflammation, Chronic | | 1 2.0| __________________________________________________________________________|____________| Thymus | + + + + + + + + + + | 47 | Congestion | | 3 2.7| Cyst | X X | 5 | Hyperplasia, Lymphoid | | 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 27 NTP Experiment-Test: 05007-06 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 07:49:23 __________________________________________________________________________________________________________________________________ | 5| 6| 7| 7| 7| 6| 6| 6| 7| 7| | | DAY ON TEST | 6| 1| 3| 3| 3| 2| 9| 9| 1| 3| | | | 8| 9| 1| 1| 1| 3| 4| 8| 6| 1| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | FISCHER 344 RATS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | 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 | | | | | | _____________________________________________________________________________________________________________________| | INTEGUMENTARY SYSTEM | | | | | | __________________________________________________________________________|____________| Mammary Gland | + + + + + + + + + + | 50 | Inflammation, Acute | | 1 2.0| Acinus, Ectasia | 4 3 4 3 3 3 3 2 | 35 2.8| Acinus, Hyperplasia | | 1 2.0| Duct, Ectasia | 2 4 3 3 | 21 2.8| __________________________________________________________________________|____________| Skin | + + + + + + + + + + | 50 | Cyst Epithelial Inclusion | | 1 | _____________________________________________________________________________________________________________________| | MUSCULOSKELETAL SYSTEM | | | | | | __________________________________________________________________________|____________| Bone | + + + + + + + + + + | 50 | Cranium, Inflammation, Chronic | 3 | 1 3.0| Cranium, Osteopetrosis | | 3 3.0| __________________________________________________________________________|____________| Skeletal Muscle | + | 2 | _____________________________________________________________________________________________________________________| | NERVOUS SYSTEM | | | | | | __________________________________________________________________________|____________| Brain | + + + + + + + + + + | 50 | Compression | X | 8 | Hemorrhage | 2 | 2 2.0| __________________________________________________________________________|____________| Spinal Cord | + | 1 | _____________________________________________________________________________________________________________________| | RESPIRATORY SYSTEM | | | | | | __________________________________________________________________________|____________| Lung | + + + + + + + + + + | 50 | Congestion | | 9 2.7| Hemorrhage | 1 | 11 1.2| Alveolar Epithelium, Hyperplasia | | 1 2.0| Alveolus, Infiltration Cellular, | | | Histiocyte | 2 2 2 | 20 1.9| Arteriole, Mineralization | 2 2 2 2 2 2 2 2 | 34 2.0| Interstitium, Inflammation, Chronic | | 2 1.0| Peribronchiolar, Inflammation, Acute | | 1 4.0| __________________________________________________________________________|____________| Nose | + + + + + + + + + + | 50 | Lumen, Hemorrhage | 2 2 1 | 22 1.6| Mucosa, Inflammation, Acute | 2 | 3 1.3| Nasolacrimal Duct, Inflammation, | | | Acute | 2 | 9 1.9| Olfactory Epithelium, Degeneration | 2 2 2 2 2 2 2 2 | 44 2.0| Respiratory Epithelium, Degeneration | 1 1 2 2 2 1 2 1 | 28 1.6| __________________________________________________________________________________________________________________________________ * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 28 NTP Experiment-Test: 05007-06 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 07:49:23 __________________________________________________________________________________________________________________________________ | 5| 6| 7| 7| 7| 6| 6| 6| 7| 7| | | DAY ON TEST | 6| 1| 3| 3| 3| 2| 9| 9| 1| 3| | | | 8| 9| 1| 1| 1| 3| 4| 8| 6| 1| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | FISCHER 344 RATS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | 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 | | | | | | __________________________________________________________________________|____________| Trachea | + + + + + + + + + + | 50 | _____________________________________________________________________________________________________________________| | SPECIAL SENSES SYSTEM | | | | | | __________________________________________________________________________|____________| Eye | + + | 10 | Cataract | 4 4 | 10 3.7| Hemorrhage | 4 2 | 4 3.5| Synechia | | 3 3.3| Retina, Degeneration | 4 4 | 10 4.0| Sclera, Mineralization | | 1 2.0| __________________________________________________________________________|____________| Zymbal's Gland | + | 2 | _____________________________________________________________________________________________________________________| | URINARY SYSTEM | | | | | | __________________________________________________________________________|____________| Kidney | + + + + + + + + + + | 50 | Cyst | | 3 | Mineralization | | 1 3.0| Nephropathy, Chronic | 2 2 1 1 2 1 2 1 1 2 | 48 2.0| Pelvis, Inflammation, Acute | | 2 3.0| Pelvis, Necrosis | | 1 4.0| Renal Tubule, Pigmentation | 1 1 2 2 2 1 2 2 2 2 | 45 1.7| __________________________________________________________________________|____________| Urinary Bladder | + + + + + + + + + + | 50 | Hemorrhage | 2 | 2 2.0| __________________________________________________________________________________________________________________________________ * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 29 NTP Experiment-Test: 05007-06 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 07:49:23 _____________________________________________________________________________________________________________________ | 6| 6| 7| 7| 7| 7| 7| 7| 7| 7| 4| 4| 4| 4| 4| 4| 6| 7| 7| 7| 6| 6| 7| 7| 7| DAY ON TEST | 3| 3| 0| 3| 3| 0| 2| 3| 3| 3| 6| 6| 6| 6| 6| 6| 8| 1| 3| 3| 1| 2| 0| 1| 3| | 0| 8| 0| 1| 1| 0| 4| 1| 4| 4| 3| 3| 3| 3| 3| 7| 7| 7| 4| 4| 9| 3| 2| 7| 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| FISCHER 344 RATS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 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 | + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Large | + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Large, Cecum | + + + + + + + + + + + + + + + + + + + +| Parasite Metazoan | X X X X | Ulcer | 2 | __________________________________________________________________________| Intestine Large, Colon | + + + + + + + + + + + + + + + + + + + +| Parasite Metazoan | X | __________________________________________________________________________| Intestine Large, Rectum | + + + + + + + + + + + + + + + + + + + +| Parasite Metazoan | X X | __________________________________________________________________________| Intestine Small | + + + + + + + + + + A + + + + + + + + +| __________________________________________________________________________| Intestine Small, Duodenum | + + + + + + + + + + A + + + + + + + + +| __________________________________________________________________________| Intestine Small, Ileum | + + + + + + + + + + A + + + + + + + + +| __________________________________________________________________________| Intestine Small, Jejunum | + + + + + + + + + + A + + + + + + + + +| __________________________________________________________________________| Liver | + + + + + + + + + + + + + + + + + + + +| Basophilic Focus | X X X X X X X X X X X X X X| Developmental Malformation | X | Fatty Change | 2 2 2 | Granuloma | 2 2 2 2 2 2 2| Hematopoietic Cell Proliferation | 1 2 2 2| Bile Duct, Hyperplasia | 1 1 1 2 1 4 1 2 1 1 | Hepatocyte, Hyperplasia | | Portal, Inflammation, Chronic | 1 2 2 1 1 1 2 2 1| __________________________________________________________________________| Mesentery | | Fat, Necrosis | | __________________________________________________________________________| Pancreas | + + + + M + + + + + A + + + + + + + + +| Acinus, Atrophy | 2 2 3 2 2 3 2| Artery, Inflammation, Chronic | | __________________________________________________________________________| Salivary Glands | + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Stomach | + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Stomach, Forestomach | + + + + + + + + + + + + + + + + + + + +| Edema | | Hyperkeratosis | | Hyperplasia, Squamous | | Inflammation, Chronic | 2 | Mineralization | 2 | Ulcer | 4 | __________________________________________________________________________| Stomach, Glandular | + + + + + + + + + + + + + + + + + + + +| Mineralization | 2 2 | Mucosa, Dilatation | 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 | __________________________________________________________________________| Tooth | | _____________________________________________________________________________________________________________________| CARDIOVASCULAR SYSTEM | | | | __________________________________________________________________________| Heart | + + + + + + + + + + + + + + + + + + + +| Cardiomyopathy, Chronic | 2 2 3 2 3 2 3 3 3 2 2 2 2 1 2 2 2| _____________________________________________________________________________________________________________________| Page 30 NTP Experiment-Test: 05007-06 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 07:49:23 _____________________________________________________________________________________________________________________ | 6| 6| 7| 7| 7| 7| 7| 7| 7| 7| 4| 4| 4| 4| 4| 4| 6| 7| 7| 7| 6| 6| 7| 7| 7| DAY ON TEST | 3| 3| 0| 3| 3| 0| 2| 3| 3| 3| 6| 6| 6| 6| 6| 6| 8| 1| 3| 3| 1| 2| 0| 1| 3| | 0| 8| 0| 1| 1| 0| 4| 1| 4| 4| 3| 3| 3| 3| 3| 7| 7| 7| 4| 4| 9| 3| 2| 7| 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| FISCHER 344 RATS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 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| _____________________________________________________________________________________________________________________| CARDIOVASCULAR SYSTEM - cont | | | | _____________________________________________________________________________________________________________________| ENDOCRINE SYSTEM | | | | __________________________________________________________________________| Adrenal Gland | + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Adrenal Gland, Cortex | + + + + + + + + + + + + + + + + + + + +| Angiectasis | | Degeneration, Fatty | 2 2 1 2 2 2 2 | Hemorrhage | | Hyperplasia | 2 2 2 2 1 | Pigmentation | 2 1 1 1 1 2 2 1 1 1 2| __________________________________________________________________________| Adrenal Gland, Medulla | + + + + + + + + + + + + + + + + + + + +| Hyperplasia | 2 2 | __________________________________________________________________________| Islets, Pancreatic | + + + + M + + + + + A + + + + + + + + +| __________________________________________________________________________| Parathyroid Gland | + + M + + + + + + M + + M + + + M + + +| __________________________________________________________________________| Pituitary Gland | + + + + + + + + + + + + + + + + + + + +| Pars Distalis, Angiectasis | 4 | Pars Distalis, Cyst | X X X X X | Pars Distalis, Hyperplasia | 2 2 2 | Pars Intermedia, Cyst | X | __________________________________________________________________________| Thyroid Gland | + + + + + + + + + + + + + + + + + + + +| Ultimobranchial Cyst | X | C-Cell, Hyperplasia | 1 2 2 1 1 1 1 2 2 2 1 1 2| Follicle, Ectasia | | _____________________________________________________________________________________________________________________| GENERAL BODY SYSTEM | | | | None | | _____________________________________________________________________________________________________________________| GENITAL SYSTEM | | | | __________________________________________________________________________| Clitoral Gland | + + + + + + + + + + + + + + + + + M + +| Abscess | | Inflammation, Chronic | 3 2 1 1 2| Inflammation, Chronic Active | 2 2 | Duct, Ectasia | 3 | __________________________________________________________________________| Ovary | + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Uterus | + + + + + + + + + + + + + + + + + + + +| Ectasia | | Cervix, Epithelium, Cyst | | Endometrium, Hyperplasia, Cystic | 2 2 | __________________________________________________________________________| Vagina | + + + | _____________________________________________________________________________________________________________________| HEMATOPOIETIC SYSTEM | | | | __________________________________________________________________________| Blood | + | __________________________________________________________________________| Bone Marrow | + + + + + + + + + + + + + + + + + + + +| Hyperplasia, Reticulum Cell | | __________________________________________________________________________| Lymph Node | + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| Page 31 NTP Experiment-Test: 05007-06 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 07:49:23 _____________________________________________________________________________________________________________________ | 6| 6| 7| 7| 7| 7| 7| 7| 7| 7| 4| 4| 4| 4| 4| 4| 6| 7| 7| 7| 6| 6| 7| 7| 7| DAY ON TEST | 3| 3| 0| 3| 3| 0| 2| 3| 3| 3| 6| 6| 6| 6| 6| 6| 8| 1| 3| 3| 1| 2| 0| 1| 3| | 0| 8| 0| 1| 1| 0| 4| 1| 4| 4| 3| 3| 3| 3| 3| 7| 7| 7| 4| 4| 9| 3| 2| 7| 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| FISCHER 344 RATS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 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 | | | | Mediastinal, Congestion | 2 2 3 2 1 2 | Mediastinal, Hyperplasia, Lymphoid | 2 | Mediastinal, Hyperplasia, Reticulum | | Cell | | __________________________________________________________________________| Lymph Node, Mandibular | + + + + + + + + + + + + + + + + + + + +| Hyperplasia, Lymphoid | 2 2 2 2 2 2 3 2 3 2 | Pigmentation | | __________________________________________________________________________| Lymph Node, Mesenteric | + + + + + + + + + + + + + + + + + + + +| Congestion | 2 | Hyperplasia, Lymphoid | 2 2 3 2| Hyperplasia, Reticulum Cell | 2 | __________________________________________________________________________| Spleen | + + + + + + + + + + + + + + + + + + + +| Fibrosis | | Hematopoietic Cell Proliferation | 3 2 3 2 2 3 2 2 2 3 2 2 | Hyperplasia, Lymphoid | | Necrosis | 2 | Pigmentation | 2 2 3 2 2 2 2 2 2 3 2 3| __________________________________________________________________________| Thymus | + + + M M M + + + + + + + + + + + + + +| Congestion | | Cyst | X | Hyperplasia, Lymphoid | 2| _____________________________________________________________________________________________________________________| INTEGUMENTARY SYSTEM | | | | __________________________________________________________________________| Mammary Gland | M + + + + + + + + + + + + + + + + + + +| Acinus, Ectasia | 3 3 3 2 2 3 2 2 2 2 2 3 3 2 3 | Acinus, Hyperplasia | 3 2 | Duct, Ectasia | 3 2 2 2 1| __________________________________________________________________________| Skin | + + + + + + + + + + + + + + + + + + + +| Alopecia | | Cyst Epithelial Inclusion | X| _____________________________________________________________________________________________________________________| MUSCULOSKELETAL SYSTEM | | | | __________________________________________________________________________| Bone | + + + + + + + + + + + + + + + + + + + +| Cranium, Osteopetrosis | 3 3 | __________________________________________________________________________| Skeletal Muscle | + | Inflammation, Chronic | | _____________________________________________________________________________________________________________________| NERVOUS SYSTEM | | | | __________________________________________________________________________| Brain | + + + + + + + + + + + + + + + + + + + +| Compression | 2 3 2 3 3| Hydrocephalus | | _____________________________________________________________________________________________________________________| RESPIRATORY SYSTEM | | | | __________________________________________________________________________| Lung | + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| Page 32 NTP Experiment-Test: 05007-06 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 07:49:23 _____________________________________________________________________________________________________________________ | 6| 6| 7| 7| 7| 7| 7| 7| 7| 7| 4| 4| 4| 4| 4| 4| 6| 7| 7| 7| 6| 6| 7| 7| 7| DAY ON TEST | 3| 3| 0| 3| 3| 0| 2| 3| 3| 3| 6| 6| 6| 6| 6| 6| 8| 1| 3| 3| 1| 2| 0| 1| 3| | 0| 8| 0| 1| 1| 0| 4| 1| 4| 4| 3| 3| 3| 3| 3| 7| 7| 7| 4| 4| 9| 3| 2| 7| 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| FISCHER 344 RATS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 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| _____________________________________________________________________________________________________________________| RESPIRATORY SYSTEM - cont | | | | Congestion | 3 | Hemorrhage | 2 1 2 | Alveolar Epithelium, Hyperplasia | | Alveolus, Infiltration Cellular, | | Histiocyte | 1 | Arteriole, Mineralization | 2 1 2 2 1 2 2 1 2 2 2 2| Interstitium, Inflammation, Chronic | 1 | Mediastinum, Inflammation, Acute | | Peribronchiolar, Inflammation, | | Chronic Active | 3 | __________________________________________________________________________| Nose | + + + + + + + + + + + + + + + + + + + +| Lumen, Hemorrhage | 2 2 2 2 2| Lumen, Inflammation, Acute | | Mucosa, Inflammation, Acute | 2 3 2 | Nasolacrimal Duct, Inflammation, | | Acute | 2 2 2| Olfactory Epithelium, Degeneration | 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2| Respiratory Epithelium, Degeneration | 1 2 1 2 1 2 1 2 1 2| __________________________________________________________________________| Trachea | + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| SPECIAL SENSES SYSTEM | | | | __________________________________________________________________________| Eye | + + + + + | Cataract | 3 4 4 2 | Hemorrhage | 3 3 | Retina, Degeneration | 4 4 4 4 4 | Sclera, Mineralization | 2 | __________________________________________________________________________| Zymbal's Gland | | _____________________________________________________________________________________________________________________| URINARY SYSTEM | | | | __________________________________________________________________________| Kidney | + + + + + + + + + + + + + + + + + + + +| Congestion | | Inflammation, Acute | 4 | Mineralization | | Nephropathy, Chronic | 2 2 4 2 2 3 2 2 2 2 3 2 2 2 3 2 2 1| Pelvis, Inflammation, Chronic | | Renal Tubule, Pigmentation | 2 2 2 2 2 2 2 2 2 2 1 2 2 2 2 3 2 2 2 2| __________________________________________________________________________| Urethra | | __________________________________________________________________________| Urinary Bladder | + + + + + + + + + + + + + + + + + + + +| Calculus Gross Observation | X | Inflammation, Chronic | 4 | _____________________________________________________________________________________________________________________| Page 33 NTP Experiment-Test: 05007-06 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 07:49:23 _____________________________________________________________________________________________________________________ | 7| 7| 7| 7| 7| 4| 6| 7| 7| 7| 2| 4| 5| 6| 7| 5| 6| 7| 7| 7| 6| 7| 7| 7| 7| DAY ON TEST | 0| 3| 3| 3| 3| 6| 4| 3| 3| 3| 7| 6| 6| 3| 3| 3| 4| 3| 3| 3| 1| 3| 3| 3| 3| | 2| 4| 4| 4| 4| 6| 0| 4| 4| 4| 3| 7| 1| 7| 4| 2| 0| 4| 4| 4| 0| 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| FISCHER 344 RATS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 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 | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Large | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Large, Cecum | + + + + + + + + + + + A + + + + + + + + + + + + +| Parasite Metazoan | X | Ulcer | | __________________________________________________________________________| Intestine Large, Colon | + + + + + + + + + + + + + + + + + + M + + + + + +| Parasite Metazoan | X X | __________________________________________________________________________| Intestine Large, Rectum | + + + + + + + + + + + + + + + + + + + + + + + + +| Parasite Metazoan | X X X X X X | __________________________________________________________________________| Intestine Small | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Small, Duodenum | + + + + + M + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Small, Ileum | + + + + + + + + + + + A + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Small, Jejunum | + + + + + + + + + + + A + + + + + + + + + + + + +| __________________________________________________________________________| Liver | + + + + + + + + + + + + + + + + + + + + + + + + +| Basophilic Focus | X X X X X X X X X X X X X X X X X X X| Developmental Malformation | X | Fatty Change | 1 2 2 | Granuloma | 2 2 2 2 | Hematopoietic Cell Proliferation | 1 2 2 | Bile Duct, Hyperplasia | 1 1 1 1 1 3 1 1 1 1 1 1 1| Hepatocyte, Hyperplasia | 3 | Portal, Inflammation, Chronic | 2 1 1 1 2 1 1 1 2 | __________________________________________________________________________| Mesentery | + + + + | Fat, Necrosis | 4 4 4 3 | __________________________________________________________________________| Pancreas | + + + + + + + + + + + A + + + + + + + + + + + + +| Acinus, Atrophy | 2 2 2 2 2 2 | Artery, Inflammation, Chronic | 2 | __________________________________________________________________________| Salivary Glands | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Stomach | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Stomach, Forestomach | + + + + + + + + + + + + + + + + + + + + + + + + +| Edema | 2 | Hyperkeratosis | 3 | Hyperplasia, Squamous | 2 | Inflammation, Chronic | 2 | Mineralization | 1 | Ulcer | 3 4 | __________________________________________________________________________| Stomach, Glandular | + + + + + + + + + + + + + + + + + + + + + + + + +| Mineralization | 2 2 2 | Mucosa, Dilatation | 2 2 2 2 2 2 2 2 2 2 2 2 2 1 2 2 1 2 2 2 2 2| __________________________________________________________________________| Tooth | + | _____________________________________________________________________________________________________________________| CARDIOVASCULAR SYSTEM | | | | __________________________________________________________________________| Heart | + + + + + + + + + + + + + + + + + + + + + + + + +| Cardiomyopathy, Chronic | 2 2 2 2 1 1 3 2 2 1 1 1 2 1 2 2 2 2| _____________________________________________________________________________________________________________________| Page 34 NTP Experiment-Test: 05007-06 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 07:49:23 _____________________________________________________________________________________________________________________ | 7| 7| 7| 7| 7| 4| 6| 7| 7| 7| 2| 4| 5| 6| 7| 5| 6| 7| 7| 7| 6| 7| 7| 7| 7| DAY ON TEST | 0| 3| 3| 3| 3| 6| 4| 3| 3| 3| 7| 6| 6| 3| 3| 3| 4| 3| 3| 3| 1| 3| 3| 3| 3| | 2| 4| 4| 4| 4| 6| 0| 4| 4| 4| 3| 7| 1| 7| 4| 2| 0| 4| 4| 4| 0| 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| FISCHER 344 RATS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 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| _____________________________________________________________________________________________________________________| CARDIOVASCULAR SYSTEM - cont | | | | _____________________________________________________________________________________________________________________| ENDOCRINE SYSTEM | | | | __________________________________________________________________________| Adrenal Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Adrenal Gland, Cortex | + + + + + + + + + + + + + + + + + + + + + + + + +| Angiectasis | 3 3 2 | Degeneration, Fatty | 2 1 1 2 2 2 2 2 2 1 2 | Hemorrhage | | Hyperplasia | 1 2 2 2 2 2 2 2 2 | Pigmentation | 1 1 1 1 1 1 1 1 1 1 1 1 2 1 1 1 1| __________________________________________________________________________| Adrenal Gland, Medulla | + + + + + + + + + + + + + + + + + + + + + + + + +| Hyperplasia | 2 2| __________________________________________________________________________| Islets, Pancreatic | + + + + + + + + + + + A + + + + + + + + + + + + +| __________________________________________________________________________| Parathyroid Gland | + + + + + + + + + M + + + + + + + + M + + + + + M| __________________________________________________________________________| Pituitary Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| Pars Distalis, Angiectasis | 3 2 3 | Pars Distalis, Cyst | X X X X X X| Pars Distalis, Hyperplasia | 2 2 2 2 1 2 2 2 | Pars Intermedia, Cyst | | __________________________________________________________________________| Thyroid Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| Ultimobranchial Cyst | | C-Cell, Hyperplasia | 2 2 1 1 2 2 1 | Follicle, Ectasia | | _____________________________________________________________________________________________________________________| GENERAL BODY SYSTEM | | | | None | | _____________________________________________________________________________________________________________________| GENITAL SYSTEM | | | | __________________________________________________________________________| Clitoral Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| Abscess | 3 | Inflammation, Chronic | 1 2 2 3 2 1 2 | Inflammation, Chronic Active | | Duct, Ectasia | 3 | __________________________________________________________________________| Ovary | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Uterus | + + + + + + + + + + + + + + + + + + + + + + + + +| Ectasia | 2 2 2 | Cervix, Epithelium, Cyst | X | Endometrium, Hyperplasia, Cystic | 2 2 2 2 2 1 2| __________________________________________________________________________| Vagina | + + + + + + | _____________________________________________________________________________________________________________________| HEMATOPOIETIC SYSTEM | | | | __________________________________________________________________________| Blood | | __________________________________________________________________________| Bone Marrow | + + + + + + + + + + + + + + + + + + + + + + + + +| Hyperplasia, Reticulum Cell | 2 | __________________________________________________________________________| Lymph Node | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| Page 35 NTP Experiment-Test: 05007-06 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 07:49:23 _____________________________________________________________________________________________________________________ | 7| 7| 7| 7| 7| 4| 6| 7| 7| 7| 2| 4| 5| 6| 7| 5| 6| 7| 7| 7| 6| 7| 7| 7| 7| DAY ON TEST | 0| 3| 3| 3| 3| 6| 4| 3| 3| 3| 7| 6| 6| 3| 3| 3| 4| 3| 3| 3| 1| 3| 3| 3| 3| | 2| 4| 4| 4| 4| 6| 0| 4| 4| 4| 3| 7| 1| 7| 4| 2| 0| 4| 4| 4| 0| 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| FISCHER 344 RATS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 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 | | | | Mediastinal, Congestion | 2 2 2 | Mediastinal, Hyperplasia, Lymphoid | 2 2 | Mediastinal, Hyperplasia, Reticulum | | Cell | 2 | __________________________________________________________________________| Lymph Node, Mandibular | + + + + + + + + + + + + + + + + + + + + + + + + +| Hyperplasia, Lymphoid | 2 2 2 2 2 3 2 2 2 2 | Pigmentation | 2 | __________________________________________________________________________| Lymph Node, Mesenteric | + + + + + + + + + + + + + + + + + + + + + + + + +| Congestion | | Hyperplasia, Lymphoid | 3 2 2 3 2 2| Hyperplasia, Reticulum Cell | | __________________________________________________________________________| Spleen | + + + + + + + + + + + + + + + + + + + + + + + + +| Fibrosis | 3 | Hematopoietic Cell Proliferation | 3 2 2 2 2 2 2 2 2 3 2 2 2 2 2 2 2| Hyperplasia, Lymphoid | 2 | Necrosis | | Pigmentation | 2 2 2 2 3 2 2 3 2 2 2 2 3 3 2 2 2 2 2| __________________________________________________________________________| Thymus | + + + + + + + + + + + + + + + + + + + + + + + + +| Congestion | | Cyst | X X | Hyperplasia, Lymphoid | | _____________________________________________________________________________________________________________________| INTEGUMENTARY SYSTEM | | | | __________________________________________________________________________| Mammary Gland | + + + + + + + M + + + + + + + + + + + + + + + + +| Acinus, Ectasia | 2 2 3 2 2 2 2 2 3 2| Acinus, Hyperplasia | 3 | Duct, Ectasia | 2 2 2 2 2 2 2 2 2 3 2| __________________________________________________________________________| Skin | + + + + + + + + + + + + + + + + + + + + + + + + +| Alopecia | 2 | Cyst Epithelial Inclusion | | _____________________________________________________________________________________________________________________| MUSCULOSKELETAL SYSTEM | | | | __________________________________________________________________________| Bone | + + + + + + + + + + + + + + + + + + + + + + + + +| Cranium, Osteopetrosis | 2 3 | __________________________________________________________________________| Skeletal Muscle | + + | Inflammation, Chronic | 4 | _____________________________________________________________________________________________________________________| NERVOUS SYSTEM | | | | __________________________________________________________________________| Brain | + + + + + + + + + + + + + + + + + + + + + + + + +| Compression | 3 2 3 2 1 2 | Hydrocephalus | 3 | _____________________________________________________________________________________________________________________| RESPIRATORY SYSTEM | | | | __________________________________________________________________________| Lung | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| Page 36 NTP Experiment-Test: 05007-06 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 07:49:23 _____________________________________________________________________________________________________________________ | 7| 7| 7| 7| 7| 4| 6| 7| 7| 7| 2| 4| 5| 6| 7| 5| 6| 7| 7| 7| 6| 7| 7| 7| 7| DAY ON TEST | 0| 3| 3| 3| 3| 6| 4| 3| 3| 3| 7| 6| 6| 3| 3| 3| 4| 3| 3| 3| 1| 3| 3| 3| 3| | 2| 4| 4| 4| 4| 6| 0| 4| 4| 4| 3| 7| 1| 7| 4| 2| 0| 4| 4| 4| 0| 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| FISCHER 344 RATS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 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| _____________________________________________________________________________________________________________________| RESPIRATORY SYSTEM - cont | | | | Congestion | 2 | Hemorrhage | 1 2 | Alveolar Epithelium, Hyperplasia | 3 | Alveolus, Infiltration Cellular, | | Histiocyte | 2 2 1 1 1 3 1 1 1 1 1| Arteriole, Mineralization | 2 2 1 2 1 2 2 2 2 2 2| Interstitium, Inflammation, Chronic | 2 | Mediastinum, Inflammation, Acute | 3 | Peribronchiolar, Inflammation, | | Chronic Active | | __________________________________________________________________________| Nose | + + + + + + + + + + + + + + + + + + + + + + + + +| Lumen, Hemorrhage | 1 2 2 1 2 2 2 2 2 2 | Lumen, Inflammation, Acute | 1 | Mucosa, Inflammation, Acute | 3 | Nasolacrimal Duct, Inflammation, | | Acute | 2 2 2 1 2 2 | Olfactory Epithelium, Degeneration | 2 2 2 2 2 2 2 1 2 2 2 2 2 2 2 2 1 2 2 2 2 2 2| Respiratory Epithelium, Degeneration | 1 1 1 1 2 1 1 1 1 2| __________________________________________________________________________| Trachea | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| SPECIAL SENSES SYSTEM | | | | __________________________________________________________________________| Eye | + + + + | Cataract | 4 4 2 3 | Hemorrhage | | Retina, Degeneration | 4 4 4 4 | Sclera, Mineralization | | __________________________________________________________________________| Zymbal's Gland | | _____________________________________________________________________________________________________________________| URINARY SYSTEM | | | | __________________________________________________________________________| Kidney | + + + + + + + + + + + + + + + + + + + + + + + + +| Congestion | | Inflammation, Acute | | Mineralization | 2 | Nephropathy, Chronic | 2 3 2 1 3 3 2 3 1 1 2 2 1 2 2 2 2 4 1 2 3| Pelvis, Inflammation, Chronic | | Renal Tubule, Pigmentation | 2 2 2 2 2 2 2 2 2 2 2 2 2 2 3 2 2 2 2 2 2 2 2| __________________________________________________________________________| Urethra | | __________________________________________________________________________| Urinary Bladder | + + + + + + + + + + + + + + + + + + + + + + + + +| Calculus Gross Observation | | Inflammation, Chronic | | _____________________________________________________________________________________________________________________| Page 37 NTP Experiment-Test: 05007-06 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 07:49:23 __________________________________________________________________________________________________________________________________ | 4| 4| 4| 4| 4| 3| 6| 7| 7| 7| | | DAY ON TEST | 6| 6| 6| 6| 6| 2| 4| 1| 3| 3| | | | 3| 3| 3| 3| 3| 3| 6| 6| 4| 4| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | FISCHER 344 RATS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | 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 | + + + + + | 50 | __________________________________________________________________________|____________| Intestine Large | + + + + + | 50 | __________________________________________________________________________|____________| Intestine Large, Cecum | M + + + + | 48 | Parasite Metazoan | | 5 | Ulcer | | 1 2.0| __________________________________________________________________________|____________| Intestine Large, Colon | + + + + + | 49 | Parasite Metazoan | X X | 5 | __________________________________________________________________________|____________| Intestine Large, Rectum | + + + + + | 50 | Parasite Metazoan | X X X | 11 | __________________________________________________________________________|____________| Intestine Small | + + + + + | 49 | __________________________________________________________________________|____________| Intestine Small, Duodenum | + + + + + | 48 | __________________________________________________________________________|____________| Intestine Small, Ileum | + + + + + | 48 | __________________________________________________________________________|____________| Intestine Small, Jejunum | + + + + + | 48 | __________________________________________________________________________|____________| Liver | + + + + + | 50 | Basophilic Focus | X X X X | 37 | Developmental Malformation | X X | 4 | Fatty Change | | 6 1.8| Granuloma | | 11 2.0| Hematopoietic Cell Proliferation | 1 2 2 | 10 1.7| Bile Duct, Hyperplasia | 1 | 24 1.3| Hepatocyte, Hyperplasia | | 1 3.0| Portal, Inflammation, Chronic | 2 2 2 | 21 1.5| __________________________________________________________________________|____________| Mesentery | | 4 | Fat, Necrosis | | 4 3.8| __________________________________________________________________________|____________| Pancreas | + + + + + | 47 | Acinus, Atrophy | 1 2 | 15 2.1| Artery, Inflammation, Chronic | | 1 2.0| __________________________________________________________________________|____________| Salivary Glands | + + + + + | 50 | __________________________________________________________________________|____________| Stomach | + + + + + | 50 | __________________________________________________________________________|____________| Stomach, Forestomach | + + + + + | 50 | Edema | | 1 2.0| Hyperkeratosis | | 1 3.0| Hyperplasia, Squamous | | 1 2.0| Inflammation, Chronic | | 2 2.0| Mineralization | 2 | 3 1.7| Ulcer | | 3 3.7| __________________________________________________________________________|____________| Stomach, Glandular | + + + + + | 50 | Mineralization | 2 | 6 2.0| Mucosa, Dilatation | 2 2 | 39 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 38 NTP Experiment-Test: 05007-06 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 07:49:23 __________________________________________________________________________________________________________________________________ | 4| 4| 4| 4| 4| 3| 6| 7| 7| 7| | | DAY ON TEST | 6| 6| 6| 6| 6| 2| 4| 1| 3| 3| | | | 3| 3| 3| 3| 3| 3| 6| 6| 4| 4| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | FISCHER 344 RATS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | 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 - cont | | | | | | __________________________________________________________________________|____________| Tooth | | 1 | _____________________________________________________________________________________________________________________| | CARDIOVASCULAR SYSTEM | | | | | | __________________________________________________________________________|____________| Heart | + + + + + | 50 | Cardiomyopathy, Chronic | 2 2 2 1 2 | 40 2.0| _____________________________________________________________________________________________________________________| | ENDOCRINE SYSTEM | | | | | | __________________________________________________________________________|____________| Adrenal Gland | + + + + + | 50 | __________________________________________________________________________|____________| Adrenal Gland, Cortex | + + + + + | 50 | Angiectasis | 3 | 4 2.8| Degeneration, Fatty | 2 2 2 2 | 22 1.8| Hemorrhage | 3 | 1 3.0| Hyperplasia | 2 2 | 16 1.9| Pigmentation | 1 1 2 | 31 1.2| __________________________________________________________________________|____________| Adrenal Gland, Medulla | + + + + + | 50 | Hyperplasia | | 4 2.0| __________________________________________________________________________|____________| Islets, Pancreatic | + + + + + | 47 | __________________________________________________________________________|____________| Parathyroid Gland | M M + + + | 41 | __________________________________________________________________________|____________| Pituitary Gland | + + + + + | 50 | Pars Distalis, Angiectasis | | 4 3.0| Pars Distalis, Cyst | X X | 13 | Pars Distalis, Hyperplasia | 1 2 | 13 1.8| Pars Intermedia, Cyst | | 1 | __________________________________________________________________________|____________| Thyroid Gland | + + + + + | 50 | Ultimobranchial Cyst | | 1 | C-Cell, Hyperplasia | 2 2 2 | 23 1.6| Follicle, Ectasia | 2 | 1 2.0| _____________________________________________________________________________________________________________________| | GENERAL BODY SYSTEM | | | | | | None | | | _____________________________________________________________________________________________________________________| | GENITAL SYSTEM | | | | | | __________________________________________________________________________|____________| Clitoral Gland | + + + + + | 49 | Abscess | | 1 3.0| Inflammation, Chronic | 3 2 | 14 1.9| Inflammation, Chronic Active | 4 2 | 4 2.5| Duct, Ectasia | | 2 3.0| __________________________________________________________________________|____________| Ovary | + + + + + | 50 | __________________________________________________________________________|____________| Uterus | + + + + + | 50 | __________________________________________________________________________________________________________________________________ * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 39 NTP Experiment-Test: 05007-06 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 07:49:23 __________________________________________________________________________________________________________________________________ | 4| 4| 4| 4| 4| 3| 6| 7| 7| 7| | | DAY ON TEST | 6| 6| 6| 6| 6| 2| 4| 1| 3| 3| | | | 3| 3| 3| 3| 3| 3| 6| 6| 4| 4| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | FISCHER 344 RATS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | 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| | | __________________________________________________________________________________________________________________________________ GENITAL SYSTEM - cont | | | | | | Ectasia | | 3 2.0| Cervix, Epithelium, Cyst | | 1 | Endometrium, Hyperplasia, Cystic | 1 | 10 1.8| __________________________________________________________________________|____________| Vagina | | 9 | _____________________________________________________________________________________________________________________| | HEMATOPOIETIC SYSTEM | | | | | | __________________________________________________________________________|____________| Blood | | 1 | __________________________________________________________________________|____________| Bone Marrow | + + + + + | 50 | Hyperplasia, Reticulum Cell | | 1 2.0| __________________________________________________________________________|____________| Lymph Node | + + + + + | 50 | Mediastinal, Congestion | 2 2 | 11 2.0| Mediastinal, Hyperplasia, Lymphoid | | 3 2.0| Mediastinal, Hyperplasia, Reticulum | | | Cell | | 1 2.0| __________________________________________________________________________|____________| Lymph Node, Mandibular | + + + + + | 50 | Hyperplasia, Lymphoid | 2 2 2 | 23 2.1| Pigmentation | | 1 2.0| __________________________________________________________________________|____________| Lymph Node, Mesenteric | + + + + + | 50 | Congestion | 2 | 2 2.0| Hyperplasia, Lymphoid | 2 | 11 2.3| Hyperplasia, Reticulum Cell | | 1 2.0| __________________________________________________________________________|____________| Spleen | + + + + + | 50 | Fibrosis | | 1 3.0| Hematopoietic Cell Proliferation | 2 2 3 3 2 | 34 2.2| Hyperplasia, Lymphoid | | 1 2.0| Necrosis | | 1 2.0| Pigmentation | 2 2 2 2 | 35 2.2| __________________________________________________________________________|____________| Thymus | + + + M + | 46 | Congestion | 4 | 1 4.0| Cyst | X | 4 | Hyperplasia, Lymphoid | | 1 2.0| _____________________________________________________________________________________________________________________| | INTEGUMENTARY SYSTEM | | | | | | __________________________________________________________________________|____________| Mammary Gland | + + + + + | 48 | Acinus, Ectasia | 2 3 2 | 28 2.4| Acinus, Hyperplasia | | 3 2.7| Duct, Ectasia | 2 2 3 2 | 20 2.1| __________________________________________________________________________|____________| Skin | + + + + + | 50 | Alopecia | | 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 40 NTP Experiment-Test: 05007-06 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 07:49:23 __________________________________________________________________________________________________________________________________ | 4| 4| 4| 4| 4| 3| 6| 7| 7| 7| | | DAY ON TEST | 6| 6| 6| 6| 6| 2| 4| 1| 3| 3| | | | 3| 3| 3| 3| 3| 3| 6| 6| 4| 4| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | FISCHER 344 RATS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | 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| | | __________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM - cont | | | | | | Cyst Epithelial Inclusion | | 1 | _____________________________________________________________________________________________________________________| | MUSCULOSKELETAL SYSTEM | | | | | | __________________________________________________________________________|____________| Bone | + + + + + | 50 | Cranium, Osteopetrosis | 3 | 5 2.8| __________________________________________________________________________|____________| Skeletal Muscle | | 3 | Inflammation, Chronic | | 1 4.0| _____________________________________________________________________________________________________________________| | NERVOUS SYSTEM | | | | | | __________________________________________________________________________|____________| Brain | + + + + + | 50 | Compression | 2 2 | 13 2.3| Hydrocephalus | | 1 3.0| _____________________________________________________________________________________________________________________| | RESPIRATORY SYSTEM | | | | | | __________________________________________________________________________|____________| Lung | + + + + + | 50 | Congestion | 3 | 3 2.7| Hemorrhage | | 5 1.6| Alveolar Epithelium, Hyperplasia | 2 2 | 3 2.3| Alveolus, Infiltration Cellular, | | | Histiocyte | 1 1 | 14 1.3| Arteriole, Mineralization | 1 2 | 25 1.8| Interstitium, Inflammation, Chronic | | 2 1.5| Mediastinum, Inflammation, Acute | | 1 3.0| Peribronchiolar, Inflammation, | | | Chronic Active | | 1 3.0| __________________________________________________________________________|____________| Nose | + + + + + | 50 | Lumen, Hemorrhage | 2 2 | 17 1.9| Lumen, Inflammation, Acute | | 1 1.0| Mucosa, Inflammation, Acute | | 4 2.5| Nasolacrimal Duct, Inflammation, | | | Acute | | 9 1.9| Olfactory Epithelium, Degeneration | 2 2 2 2 | 44 2.0| Respiratory Epithelium, Degeneration | 1 1 | 22 1.3| __________________________________________________________________________|____________| Trachea | + + + + + | 50 | _____________________________________________________________________________________________________________________| | SPECIAL SENSES SYSTEM | | | | | | __________________________________________________________________________|____________| Eye | | 9 | Cataract | | 8 3.3| Hemorrhage | | 2 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 41 NTP Experiment-Test: 05007-06 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 07:49:23 __________________________________________________________________________________________________________________________________ | 4| 4| 4| 4| 4| 3| 6| 7| 7| 7| | | DAY ON TEST | 6| 6| 6| 6| 6| 2| 4| 1| 3| 3| | | | 3| 3| 3| 3| 3| 3| 6| 6| 4| 4| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | FISCHER 344 RATS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | 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| | | __________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM - cont | | | | | | Retina, Degeneration | | 9 4.0| Sclera, Mineralization | | 1 2.0| __________________________________________________________________________|____________| Zymbal's Gland | + | 1 | _____________________________________________________________________________________________________________________| | URINARY SYSTEM | | | | | | __________________________________________________________________________|____________| Kidney | + + + + + | 50 | Congestion | 2 | 1 2.0| Inflammation, Acute | | 1 4.0| Mineralization | | 1 2.0| Nephropathy, Chronic | 2 1 2 2 | 43 2.1| Pelvis, Inflammation, Chronic | 3 | 1 3.0| Renal Tubule, Pigmentation | 2 2 2 2 | 47 2.0| __________________________________________________________________________|____________| Urethra | + | 1 | __________________________________________________________________________|____________| Urinary Bladder | + + + + + | 50 | Calculus Gross Observation | X | 2 | Inflammation, Chronic | 4 | 2 4.0| __________________________________________________________________________________________________________________________________ * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 42 NTP Experiment-Test: 05007-06 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 07:49:23 _____________________________________________________________________________________________________________________ | 5| 7| 7| 7| 7| 6| 7| 7| 7| 7| 5| 6| 7| 7| 7| 5| 7| 7| 7| 7| 4| 4| 4| 4| 4| DAY ON TEST | 8| 2| 2| 2| 2| 9| 0| 2| 2| 2| 6| 6| 2| 2| 2| 6| 2| 2| 2| 2| 6| 6| 6| 6| 6| | 5| 9| 9| 9| 9| 8| 1| 9| 9| 9| 1| 2| 3| 9| 9| 1| 9| 9| 9| 9| 2| 2| 2| 2| 2| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 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 | + + + + + + + + + + + + + + + + + + + + | __________________________________________________________________________| Intestine Large | + + + + + + + + + + + + + + + + + + + + | __________________________________________________________________________| Intestine Large, Cecum | + + + + + + + + + + + + + + + + + + + + | Parasite Metazoan | X X | __________________________________________________________________________| Intestine Large, Colon | + + + + + + + + + + + + + + + + + + + + | Parasite Metazoan | X X X | __________________________________________________________________________| Intestine Large, Rectum | + + + + + + + + + + + + + + + + + + + + | Parasite Metazoan | | __________________________________________________________________________| Intestine Small | + + + + + + + + + + + + + + + + + + + + | __________________________________________________________________________| Intestine Small, Duodenum | + + + + + + + + + + + + + + + + + + + + | __________________________________________________________________________| Intestine Small, Ileum | + + + + + + + + + + + + + + + + + + + + | Inflammation, Chronic | | __________________________________________________________________________| Intestine Small, Jejunum | + + + + + + + + + + + + + + + + + + + + | __________________________________________________________________________| Liver | + + + + + + + + + + + + + + + + + + + + | Angiectasis | 3 | Basophilic Focus | X X X X X X X X X X X X X X X X | Congestion | | Developmental Malformation | X X X | Focal Cellular Change | | Necrosis | 2 1 | Vacuolization Cytoplasmic | 2 1 | Bile Duct, Hyperplasia | 2 2 2 2 2 2 2 2 3 2 4 2 2 2 2 2 2 2 3 | Portal, Inflammation, Chronic | 2 2 2 1 2 2 1 2 2 2 1 3 1 2 2 2 2 2 2 | __________________________________________________________________________| Mesentery | + + | Fat, Necrosis | 3 3 | __________________________________________________________________________| Pancreas | + + + + + + + + + + + + + + + + + + + + | Acinus, Atrophy | 3 1 1 2 2 2 2 1 2 1 | Acinus, Hyperplasia | | Duct, Ectasia | 2 | __________________________________________________________________________| Salivary Glands | + + + + + + + + + + + + + + + + + + + + | Infiltration Cellular, Lymphocyte | 2 2 2 2 | __________________________________________________________________________| Stomach | + + + + + + + + + + + + + + + + + + + + | __________________________________________________________________________| Stomach, Forestomach | + + + + + + + + + + + + + + + + + + + + | Edema | | Hyperkeratosis | 3 | Inflammation, Acute | 2 | Inflammation, Chronic Active | 3 | Ulcer | 3 | __________________________________________________________________________| Stomach, Glandular | + + + + + + + + + + + + + + + + + + + + | Mineralization | 3 | Mucosa, Dilatation | 1 2 1 2 1 1 1 2 1 2 2 1 2 2 | __________________________________________________________________________| Tongue | | _____________________________________________________________________________________________________________________| CARDIOVASCULAR SYSTEM | | | | _____________________________________________________________________________________________________________________| Page 43 NTP Experiment-Test: 05007-06 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 07:49:23 _____________________________________________________________________________________________________________________ | 5| 7| 7| 7| 7| 6| 7| 7| 7| 7| 5| 6| 7| 7| 7| 5| 7| 7| 7| 7| 4| 4| 4| 4| 4| DAY ON TEST | 8| 2| 2| 2| 2| 9| 0| 2| 2| 2| 6| 6| 2| 2| 2| 6| 2| 2| 2| 2| 6| 6| 6| 6| 6| | 5| 9| 9| 9| 9| 8| 1| 9| 9| 9| 1| 2| 3| 9| 9| 1| 9| 9| 9| 9| 2| 2| 2| 2| 2| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 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| _____________________________________________________________________________________________________________________| CARDIOVASCULAR SYSTEM - cont | | | | __________________________________________________________________________| Blood Vessel | + + | Artery, Inflammation, Chronic | 2 4 | __________________________________________________________________________| Heart | + + + + + + + + + + + + + + + + + + + + | Cardiomyopathy, Chronic | 2 2 2 2 2 2 1 3 2 2 2 2 1 2 2 2 3 3 3 2 | Mineralization | 2 2 | Pigmentation, Hemosiderin | | _____________________________________________________________________________________________________________________| ENDOCRINE SYSTEM | | | | __________________________________________________________________________| Adrenal Gland | + + + + + + + + + + + + + + + + + + + + | __________________________________________________________________________| Adrenal Gland, Cortex | + + + + + + + + + + + + + + + + + + + | Accessory Adrenal Cortical Nodule | X | Degeneration, Fatty | 1 2 2 2 2 1 2 2 2 2 3 2 2 2 2 | Hyperplasia | 2 2 2 2 | Infiltration Cellular, Lymphocyte | | Necrosis | 2 | Pigmentation | | __________________________________________________________________________| Adrenal Gland, Medulla | + + + + + + + + + + + + + + + + + + + + | Hyperplasia | 2 1 1 2 2 | __________________________________________________________________________| Islets, Pancreatic | + + + + + + + + + + + + + + + + + + + + | Hyperplasia | | __________________________________________________________________________| Parathyroid Gland | M + M + + + + M + + M + M + + + + + + M | Hypertrophy | | __________________________________________________________________________| Pituitary Gland | + + + + + + + + + + + + + + + + + + + + | Pars Distalis, Cyst | X X X | Pars Distalis, Hemorrhage | 3 | Pars Distalis, Hyperplasia | 2 2 3 2 2 | Pars Distalis, Infarct | 4 | Pars Distalis, Infiltration Cellular,| | Lymphocyte | 2 | __________________________________________________________________________| Thyroid Gland | + + + + + + + + + + + + + + + + + + + + | Ultimobranchial Cyst | | C-Cell, Hyperplasia | 2 2 2 2 | Follicle, Ectasia | 2 | _____________________________________________________________________________________________________________________| GENERAL BODY SYSTEM | | | | None | | _____________________________________________________________________________________________________________________| GENITAL SYSTEM | | | | __________________________________________________________________________| Epididymis | + + + + + + + + + + + + + + + + + + + + | Inflammation, Chronic | 2 2 | Inflammation, Chronic Active | | __________________________________________________________________________| Preputial Gland | + + + + + + + + + + + + + + + + + + + + | Abscess | 4 | Inflammation, Chronic | 2 1 2 2 2 2 2 2 | _____________________________________________________________________________________________________________________| Page 44 NTP Experiment-Test: 05007-06 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 07:49:23 _____________________________________________________________________________________________________________________ | 5| 7| 7| 7| 7| 6| 7| 7| 7| 7| 5| 6| 7| 7| 7| 5| 7| 7| 7| 7| 4| 4| 4| 4| 4| DAY ON TEST | 8| 2| 2| 2| 2| 9| 0| 2| 2| 2| 6| 6| 2| 2| 2| 6| 2| 2| 2| 2| 6| 6| 6| 6| 6| | 5| 9| 9| 9| 9| 8| 1| 9| 9| 9| 1| 2| 3| 9| 9| 1| 9| 9| 9| 9| 2| 2| 2| 2| 2| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 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 | 3 3 2 3 3 | Duct, Ectasia | 2 | __________________________________________________________________________| Prostate | + + + + + + + + + + + + + + + + + + + + | Inflammation, Acute | | Inflammation, Chronic | 3 2 | Inflammation, Chronic Active | 2 3 2 2 3 3 2 2 2 2 3 4 3 2 2 3 2 | __________________________________________________________________________| Seminal Vesicle | + + + + + + + + + + + + + + + + + + + + | __________________________________________________________________________| Testes | + + + + + + + + + + + + + + + + + + + + | Atrophy | 3 4 4 | Necrosis | 4 | Interstitial Cell, Hyperplasia | 1 2 2 1 2 1 | _____________________________________________________________________________________________________________________| HEMATOPOIETIC SYSTEM | | | | __________________________________________________________________________| Blood | + | __________________________________________________________________________| Bone Marrow | + + + + + + + + + + + + + + + + + + + + | Hemorrhage | | Necrosis | | __________________________________________________________________________| Lymph Node | + + + + + + + + + + + + + + + + + + + + | Mediastinal, Congestion | | Mediastinal, Hemorrhage | | Mediastinal, Infiltration Cellular, | | Plasma Cell | 2 | __________________________________________________________________________| Lymph Node, Mandibular | + + + + + + + + + + + + + + + + + + + + | Congestion | | Cyst | X X | Hyperplasia, Lymphoid | 2 2 2 3 2 2 2 3 2 2 3 3 2 2 2 2 | __________________________________________________________________________| Lymph Node, Mesenteric | + + + + + + + + + + + + + + + + + + + + | Congestion | | __________________________________________________________________________| Spleen | + + + + + + + + + + + + + + + + + + + + | Fibrosis | 3 | Hematopoietic Cell Proliferation | 2 2 2 1 1 1 1 1 1 3 2 1 1 | Necrosis | 2 | Pigmentation | 2 2 2 3 3 3 2 2 2 2 | __________________________________________________________________________| Thymus | + M + + + + + + + + + + M + + + + + + + | Congestion | | _____________________________________________________________________________________________________________________| INTEGUMENTARY SYSTEM | | | | __________________________________________________________________________| Mammary Gland | M + + + + + + + + + + M + + + + + + + + | Acinus, Ectasia | 2 2 3 2 4 2 3 1 | Acinus, Hyperplasia | | Duct, Ectasia | | __________________________________________________________________________| Skin | + + + + + + M + + + + + + + + + + + + + | Abscess | | _____________________________________________________________________________________________________________________| MUSCULOSKELETAL SYSTEM | | _____________________________________________________________________________________________________________________| Page 45 NTP Experiment-Test: 05007-06 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 07:49:23 _____________________________________________________________________________________________________________________ | 5| 7| 7| 7| 7| 6| 7| 7| 7| 7| 5| 6| 7| 7| 7| 5| 7| 7| 7| 7| 4| 4| 4| 4| 4| DAY ON TEST | 8| 2| 2| 2| 2| 9| 0| 2| 2| 2| 6| 6| 2| 2| 2| 6| 2| 2| 2| 2| 6| 6| 6| 6| 6| | 5| 9| 9| 9| 9| 8| 1| 9| 9| 9| 1| 2| 3| 9| 9| 1| 9| 9| 9| 9| 2| 2| 2| 2| 2| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 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 | + + + + + + + + + + + + + + + + + + + + | Cranium, Fibrous Osteodystrophy | 2 | Femur, Fibrous Osteodystrophy | 2 2 | Femur, Hyperostosis | 2 | _____________________________________________________________________________________________________________________| NERVOUS SYSTEM | | | | __________________________________________________________________________| Brain | + + + + + + + + + + + + + + + + + + + + | Compression | 2 2 3 | Hemorrhage | 2 | Hydrocephalus | | _____________________________________________________________________________________________________________________| RESPIRATORY SYSTEM | | | | __________________________________________________________________________| Lung | + + + + + + + + + + + + + + + + + + + + | Congestion | | Hemorrhage | 2 1 | Alveolar Epithelium, Hyperplasia | | Alveolus, Infiltration Cellular, | | Histiocyte | 1 | Arteriole, Mineralization | 2 2 2 2 1 2 2 2 2 2 2 2 2 2 | Interstitium, Inflammation, Chronic | | __________________________________________________________________________| Nose | + + + + + + + + + + + + + + + + + + + + | Lumen, Hemorrhage | 2 2 1 | Mucosa, Inflammation, Acute | 3 3 3 4 2 | Nasolacrimal Duct, Hemorrhage | 2 | Nasolacrimal Duct, Inflammation, | | Acute | 2 2 1 1 1 1 2 2 | Olfactory Epithelium, Degeneration | 1 2 2 2 1 1 1 1 2 2 2 2 2 | Respiratory Epithelium, Degeneration | 1 1 1 1 1 2 | __________________________________________________________________________| Trachea | + + + + + + + + + + + + + + + + + + + + | _____________________________________________________________________________________________________________________| SPECIAL SENSES SYSTEM | | | | __________________________________________________________________________| Ear | | Canal, Abscess | | __________________________________________________________________________| Eye | + + | Cataract | 3 | Hemorrhage | | Posterior Chamber, Synechia | | Retina, Degeneration | 3 3 | Sclera, Mineralization | 3 | __________________________________________________________________________| Zymbal's Gland | | _____________________________________________________________________________________________________________________| URINARY SYSTEM | | | | __________________________________________________________________________| Kidney | + + + + + + + + + + + + + + + + + + + + | _____________________________________________________________________________________________________________________| Page 46 NTP Experiment-Test: 05007-06 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 07:49:23 _____________________________________________________________________________________________________________________ | 5| 7| 7| 7| 7| 6| 7| 7| 7| 7| 5| 6| 7| 7| 7| 5| 7| 7| 7| 7| 4| 4| 4| 4| 4| DAY ON TEST | 8| 2| 2| 2| 2| 9| 0| 2| 2| 2| 6| 6| 2| 2| 2| 6| 2| 2| 2| 2| 6| 6| 6| 6| 6| | 5| 9| 9| 9| 9| 8| 1| 9| 9| 9| 1| 2| 3| 9| 9| 1| 9| 9| 9| 9| 2| 2| 2| 2| 2| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 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 | | | | Cyst | X | Necrosis | | Nephropathy, Chronic | 2 4 3 4 2 3 2 2 3 2 3 4 4 3 2 2 3 3 4 3 | Renal Tubule, Mineralization | | Renal Tubule, Pigmentation | 1 2 2 2 2 2 1 2 2 2 1 2 1 2 2 2 2 2 2 1 | __________________________________________________________________________| Urethra | | Calculus Micro Observation Only | | __________________________________________________________________________| Urinary Bladder | + + + + + + + + + + + + + + + + + + + + | Calculus Micro Observation Only | X | Infiltration Cellular, Lymphocyte | 2 | _____________________________________________________________________________________________________________________| Page 47 NTP Experiment-Test: 05007-06 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 07:49:23 _____________________________________________________________________________________________________________________ | 4| 7| 7| 7| 7| 6| 6| 7| 7| 7| 7| 7| 7| 7| 7| 4| 5| 6| 6| 7| 4| 4| 4| 4| 4| DAY ON TEST | 7| 0| 2| 2| 2| 3| 8| 2| 2| 2| 2| 2| 3| 3| 3| 6| 6| 1| 8| 3| 6| 6| 6| 6| 6| | 0| 0| 9| 9| 9| 0| 1| 9| 9| 9| 9| 9| 0| 0| 0| 4| 7| 4| 8| 0| 2| 2| 2| 2| 2| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 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 | + + + + + + + + + + + + + + + + + + + + | __________________________________________________________________________| Intestine Large | + + + + + + + + + + + + + + + + + + + + | __________________________________________________________________________| Intestine Large, Cecum | + + + + + + + + + + + + + + + + + + + + | Parasite Metazoan | | __________________________________________________________________________| Intestine Large, Colon | + + + + + + + + + + + + + + + + + + M + | Parasite Metazoan | X X | __________________________________________________________________________| Intestine Large, Rectum | + + + + + + + + + + + + + + + M + + M + | Parasite Metazoan | X X | __________________________________________________________________________| Intestine Small | + + + + + + + + + + + + + + + + + + + + | __________________________________________________________________________| Intestine Small, Duodenum | + + + + + + + + + + + + + + + + + + + + | __________________________________________________________________________| Intestine Small, Ileum | + + + + + + + + + + + + + + + + + + + + | Inflammation, Chronic | 3 | __________________________________________________________________________| Intestine Small, Jejunum | + + + + + + + + + + + + + + + M + + + + | __________________________________________________________________________| Liver | + + + + + + + + + + + + + + + + + + + + | Angiectasis | 1 1 | Basophilic Focus | X X X X X X X X X X X X | Congestion | | Developmental Malformation | X | Focal Cellular Change | X | Necrosis | 2 | Vacuolization Cytoplasmic | 2 | Bile Duct, Hyperplasia | 3 4 2 2 1 3 2 3 2 2 2 2 2 2 2 2 2 2 2 2 | Portal, Inflammation, Chronic | 2 2 1 1 2 2 2 2 1 2 2 2 2 2 2 1 2 2 | __________________________________________________________________________| Mesentery | + + | Fat, Necrosis | 4 4 | __________________________________________________________________________| Pancreas | + + + + + + + + + + + + + + + + + + + + | Acinus, Atrophy | 2 3 2 2 3 2 2 4 2 2 | Acinus, Hyperplasia | 2 | Duct, Ectasia | | __________________________________________________________________________| Salivary Glands | + + + + + + + + + + + + + + + + + + + + | Infiltration Cellular, Lymphocyte | 2 | __________________________________________________________________________| Stomach | + + + + + + + + + + + + + + + + + + + + | __________________________________________________________________________| Stomach, Forestomach | + + + + + + + + + + + + + + + + + + + + | Edema | 3 | Hyperkeratosis | | Inflammation, Acute | | Inflammation, Chronic Active | | Ulcer | | __________________________________________________________________________| Stomach, Glandular | + + + + + + + + + + + + + + + + + + + + | Mineralization | 2 | Mucosa, Dilatation | 2 2 2 2 2 2 2 2 2 1 2 | __________________________________________________________________________| Tongue | + | _____________________________________________________________________________________________________________________| CARDIOVASCULAR SYSTEM | | | | _____________________________________________________________________________________________________________________| Page 48 NTP Experiment-Test: 05007-06 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 07:49:23 _____________________________________________________________________________________________________________________ | 4| 7| 7| 7| 7| 6| 6| 7| 7| 7| 7| 7| 7| 7| 7| 4| 5| 6| 6| 7| 4| 4| 4| 4| 4| DAY ON TEST | 7| 0| 2| 2| 2| 3| 8| 2| 2| 2| 2| 2| 3| 3| 3| 6| 6| 1| 8| 3| 6| 6| 6| 6| 6| | 0| 0| 9| 9| 9| 0| 1| 9| 9| 9| 9| 9| 0| 0| 0| 4| 7| 4| 8| 0| 2| 2| 2| 2| 2| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 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| _____________________________________________________________________________________________________________________| CARDIOVASCULAR SYSTEM - cont | | | | __________________________________________________________________________| Blood Vessel | + + + + | Artery, Inflammation, Chronic | 2 4 2 4 | __________________________________________________________________________| Heart | + + + + + + + + + + + + + + + + + + + + | Cardiomyopathy, Chronic | 3 2 3 2 2 3 3 2 1 3 1 3 3 2 2 2 3 2 | Mineralization | | Pigmentation, Hemosiderin | 3 | _____________________________________________________________________________________________________________________| ENDOCRINE SYSTEM | | | | __________________________________________________________________________| Adrenal Gland | + + + + + + + + + + + + + + + + + + + + | __________________________________________________________________________| Adrenal Gland, Cortex | + + + + + + + + + + + + + + + + + + + + | Accessory Adrenal Cortical Nodule | | Degeneration, Fatty | 1 1 2 1 2 1 1 2 | Hyperplasia | 2 2 2 2 1 2 | Infiltration Cellular, Lymphocyte | 2 | Necrosis | | Pigmentation | | __________________________________________________________________________| Adrenal Gland, Medulla | + + + + + + + + + + + + + + + + + + + + | Hyperplasia | 2 2 2 | __________________________________________________________________________| Islets, Pancreatic | + + + + + + + + + + + + + + + + + + + + | Hyperplasia | 2 | __________________________________________________________________________| Parathyroid Gland | + + + + + M + + M + + + M + + + M + + + | Hypertrophy | | __________________________________________________________________________| Pituitary Gland | + + + + + + + + + + + + + + + + + + + + | Pars Distalis, Cyst | | Pars Distalis, Hemorrhage | 4 | Pars Distalis, Hyperplasia | 2 2 1 | Pars Distalis, Infarct | | Pars Distalis, Infiltration Cellular,| | Lymphocyte | | __________________________________________________________________________| Thyroid Gland | + + + + + + + + + + + + + + + + + + + + | Ultimobranchial Cyst | X | C-Cell, Hyperplasia | 2 1 1 2 | Follicle, Ectasia | 2 2 2 | _____________________________________________________________________________________________________________________| GENERAL BODY SYSTEM | | | | None | | _____________________________________________________________________________________________________________________| GENITAL SYSTEM | | | | __________________________________________________________________________| Epididymis | + + + + + + + + + + + + + + + + + + M + | Inflammation, Chronic | 2 | Inflammation, Chronic Active | | __________________________________________________________________________| Preputial Gland | + + + + + + + + + + + + M + + + + + M + | Abscess | | Inflammation, Chronic | 2 2 2 2 2 3 3 | _____________________________________________________________________________________________________________________| Page 49 NTP Experiment-Test: 05007-06 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 07:49:23 _____________________________________________________________________________________________________________________ | 4| 7| 7| 7| 7| 6| 6| 7| 7| 7| 7| 7| 7| 7| 7| 4| 5| 6| 6| 7| 4| 4| 4| 4| 4| DAY ON TEST | 7| 0| 2| 2| 2| 3| 8| 2| 2| 2| 2| 2| 3| 3| 3| 6| 6| 1| 8| 3| 6| 6| 6| 6| 6| | 0| 0| 9| 9| 9| 0| 1| 9| 9| 9| 9| 9| 0| 0| 0| 4| 7| 4| 8| 0| 2| 2| 2| 2| 2| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 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 | 3 3 2 2 2 2 | Duct, Ectasia | | __________________________________________________________________________| Prostate | + + + + + + + + + + + + + + + + + + + + | Inflammation, Acute | | Inflammation, Chronic | 4 2 | Inflammation, Chronic Active | 2 2 2 3 3 3 2 2 3 3 3 3 3 3 3 2 3 | __________________________________________________________________________| Seminal Vesicle | + + + + + + + + + + + + + + + + + + + + | __________________________________________________________________________| Testes | + + + + + + + + + + + + + + + + + + M + | Atrophy | 4 4 3 | Necrosis | | Interstitial Cell, Hyperplasia | 2 2 2 1 2 | _____________________________________________________________________________________________________________________| HEMATOPOIETIC SYSTEM | | | | __________________________________________________________________________| Blood | + | __________________________________________________________________________| Bone Marrow | + + + + + + + + + + + + + + + + + + + + | Hemorrhage | 3 | Necrosis | 3 | __________________________________________________________________________| Lymph Node | + + + + + + + + + + + + + + + + + + + + | Mediastinal, Congestion | 2 | Mediastinal, Hemorrhage | 3 | Mediastinal, Infiltration Cellular, | | Plasma Cell | | __________________________________________________________________________| Lymph Node, Mandibular | + + + + + + + + + + + + + + + + + + + + | Congestion | | Cyst | X | Hyperplasia, Lymphoid | 3 2 2 2 2 2 2 2 2 2 2 2 2 2 2 | __________________________________________________________________________| Lymph Node, Mesenteric | + + + + + + + + + + + + + + + + + + + + | Congestion | | __________________________________________________________________________| Spleen | + + + + + + + + + + + + + + + + + + + + | Fibrosis | 2 3 3 2 | Hematopoietic Cell Proliferation | 1 2 2 1 1 2 1 2 2 2 2 2 | Necrosis | 3 | Pigmentation | 2 2 2 2 2 2 3 2 | __________________________________________________________________________| Thymus | + + + + + + + + + + + + + + + M + + + + | Congestion | | _____________________________________________________________________________________________________________________| INTEGUMENTARY SYSTEM | | | | __________________________________________________________________________| Mammary Gland | + + + + + + + + + + + + + + + + M + + + | Acinus, Ectasia | 3 2 4 2 2 2 2 2 2 | Acinus, Hyperplasia | 2 2 | Duct, Ectasia | | __________________________________________________________________________| Skin | + + + + + + + + + + + + + + + + + + + + | Abscess | 4 | _____________________________________________________________________________________________________________________| MUSCULOSKELETAL SYSTEM | | _____________________________________________________________________________________________________________________| Page 50 NTP Experiment-Test: 05007-06 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 07:49:23 _____________________________________________________________________________________________________________________ | 4| 7| 7| 7| 7| 6| 6| 7| 7| 7| 7| 7| 7| 7| 7| 4| 5| 6| 6| 7| 4| 4| 4| 4| 4| DAY ON TEST | 7| 0| 2| 2| 2| 3| 8| 2| 2| 2| 2| 2| 3| 3| 3| 6| 6| 1| 8| 3| 6| 6| 6| 6| 6| | 0| 0| 9| 9| 9| 0| 1| 9| 9| 9| 9| 9| 0| 0| 0| 4| 7| 4| 8| 0| 2| 2| 2| 2| 2| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 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 | + + + + + + + + + + + + + + + + + + + + | Cranium, Fibrous Osteodystrophy | | Femur, Fibrous Osteodystrophy | 2 | Femur, Hyperostosis | | _____________________________________________________________________________________________________________________| NERVOUS SYSTEM | | | | __________________________________________________________________________| Brain | + + + + + + + + + + + + + + + + + + + + | Compression | 2 | Hemorrhage | 2 | Hydrocephalus | | _____________________________________________________________________________________________________________________| RESPIRATORY SYSTEM | | | | __________________________________________________________________________| Lung | + + + + + + + + + + + + + + + + + + + + | Congestion | 3 | Hemorrhage | | Alveolar Epithelium, Hyperplasia | | Alveolus, Infiltration Cellular, | | Histiocyte | 2 2 2 2 | Arteriole, Mineralization | 2 2 1 2 1 2 2 2 2 2 2 | Interstitium, Inflammation, Chronic | | __________________________________________________________________________| Nose | + + + + + + + + + + + + + + + + + + + + | Lumen, Hemorrhage | 1 1 2 2 | Mucosa, Inflammation, Acute | 2 1 2 3 | Nasolacrimal Duct, Hemorrhage | 2 2 | Nasolacrimal Duct, Inflammation, | | Acute | 2 2 1 1 | Olfactory Epithelium, Degeneration | 2 2 2 2 2 2 2 2 2 2 1 2 2 | Respiratory Epithelium, Degeneration | 2 | __________________________________________________________________________| Trachea | + + + + + + + + + + + + + + + + + + + + | _____________________________________________________________________________________________________________________| SPECIAL SENSES SYSTEM | | | | __________________________________________________________________________| Ear | + | Canal, Abscess | 4 | __________________________________________________________________________| Eye | + + + + + | Cataract | 2 4 4 4 4 | Hemorrhage | 4 3 | Posterior Chamber, Synechia | 4 | Retina, Degeneration | 4 4 4 4 4 | Sclera, Mineralization | 2 | __________________________________________________________________________| Zymbal's Gland | | _____________________________________________________________________________________________________________________| URINARY SYSTEM | | | | __________________________________________________________________________| Kidney | + + + + + + + + + + + + + + + + + + + + | _____________________________________________________________________________________________________________________| Page 51 NTP Experiment-Test: 05007-06 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 07:49:23 _____________________________________________________________________________________________________________________ | 4| 7| 7| 7| 7| 6| 6| 7| 7| 7| 7| 7| 7| 7| 7| 4| 5| 6| 6| 7| 4| 4| 4| 4| 4| DAY ON TEST | 7| 0| 2| 2| 2| 3| 8| 2| 2| 2| 2| 2| 3| 3| 3| 6| 6| 1| 8| 3| 6| 6| 6| 6| 6| | 0| 0| 9| 9| 9| 0| 1| 9| 9| 9| 9| 9| 0| 0| 0| 4| 7| 4| 8| 0| 2| 2| 2| 2| 2| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 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 | | | | Cyst | X | Necrosis | 4 | Nephropathy, Chronic | 2 3 2 4 4 2 3 4 4 3 4 3 2 2 4 1 2 1 2 3 | Renal Tubule, Mineralization | 4 | Renal Tubule, Pigmentation | 2 2 1 1 1 2 2 2 2 2 2 2 2 1 1 2 | __________________________________________________________________________| Urethra | + + | Calculus Micro Observation Only | X X | __________________________________________________________________________| Urinary Bladder | + + + + + + + + + + + + + + + + + + + + | Calculus Micro Observation Only | | Infiltration Cellular, Lymphocyte | 2 | _____________________________________________________________________________________________________________________| Page 52 NTP Experiment-Test: 05007-06 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 07:49:23 __________________________________________________________________________________________________________________________________ | 4| 4| 6| 7| 7| 6| 7| 7| 7| 7| | | DAY ON TEST | 5| 9| 4| 1| 3| 4| 1| 3| 3| 3| | | | 5| 3| 0| 7| 0| 0| 2| 0| 0| 0| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | 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 | + + + + + + + + + + | 50 | __________________________________________________________________________|____________| Intestine Large | + + + + + + + + + + | 50 | __________________________________________________________________________|____________| Intestine Large, Cecum | + + + + + + + + + + | 50 | Parasite Metazoan | X X | 4 | __________________________________________________________________________|____________| Intestine Large, Colon | + + + + + + + + + + | 49 | Parasite Metazoan | | 5 | __________________________________________________________________________|____________| Intestine Large, Rectum | + + + + + + + + + + | 48 | Parasite Metazoan | X | 3 | __________________________________________________________________________|____________| Intestine Small | + A + + + + + + + + | 49 | __________________________________________________________________________|____________| Intestine Small, Duodenum | + A + + + + + + + + | 49 | __________________________________________________________________________|____________| Intestine Small, Ileum | + A + + + + + + + + | 49 | Inflammation, Chronic | | 1 3.0| __________________________________________________________________________|____________| Intestine Small, Jejunum | + A + + + + + + + + | 48 | __________________________________________________________________________|____________| Liver | + + + + + + + + + + | 50 | Angiectasis | 1 | 4 1.5| Basophilic Focus | X X X X X X | 34 | Congestion | 3 | 1 3.0| Developmental Malformation | X X X | 7 | Focal Cellular Change | X | 2 | Necrosis | | 3 1.7| Vacuolization Cytoplasmic | 1 | 4 1.5| Bile Duct, Hyperplasia | 2 2 2 2 2 2 2 2 2 2 | 49 2.2| Portal, Inflammation, Chronic | 2 2 2 2 2 1 2 2 2 | 46 1.8| __________________________________________________________________________|____________| Mesentery | | 4 | Fat, Necrosis | | 4 3.5| __________________________________________________________________________|____________| Pancreas | + + + + + + + + + + | 50 | Acinus, Atrophy | 2 2 2 2 3 | 25 2.1| Acinus, Hyperplasia | | 1 2.0| Duct, Ectasia | | 1 2.0| __________________________________________________________________________|____________| Salivary Glands | + + + + + + + + + + | 50 | Infiltration Cellular, Lymphocyte | | 5 2.0| __________________________________________________________________________|____________| Stomach | + + + + + + + + + + | 50 | __________________________________________________________________________|____________| Stomach, Forestomach | + + + + + + + + + + | 50 | Edema | | 1 3.0| Hyperkeratosis | | 1 3.0| Inflammation, Acute | 2 | 2 2.0| Inflammation, Chronic Active | | 1 3.0| Ulcer | | 1 3.0| __________________________________________________________________________|____________| Stomach, Glandular | + + + + + M + + + + | 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 53 NTP Experiment-Test: 05007-06 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 07:49:23 __________________________________________________________________________________________________________________________________ | 4| 4| 6| 7| 7| 6| 7| 7| 7| 7| | | DAY ON TEST | 5| 9| 4| 1| 3| 4| 1| 3| 3| 3| | | | 5| 3| 0| 7| 0| 0| 2| 0| 0| 0| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | 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 | | | | | | Mineralization | | 2 2.5| Mucosa, Dilatation | 2 2 2 2 2 | 30 1.7| __________________________________________________________________________|____________| Tongue | | 1 | _____________________________________________________________________________________________________________________| | CARDIOVASCULAR SYSTEM | | | | | | __________________________________________________________________________|____________| Blood Vessel | | 6 | Artery, Inflammation, Chronic | | 6 3.0| __________________________________________________________________________|____________| Heart | + + + + + + + + + + | 50 | Cardiomyopathy, Chronic | 2 2 3 2 3 1 2 2 3 | 47 2.2| Mineralization | | 2 2.0| Pigmentation, Hemosiderin | | 1 3.0| _____________________________________________________________________________________________________________________| | ENDOCRINE SYSTEM | | | | | | __________________________________________________________________________|____________| Adrenal Gland | + + + + + + + + + + | 50 | __________________________________________________________________________|____________| Adrenal Gland, Cortex | + + + + + + + + + + | 49 | Accessory Adrenal Cortical Nodule | X | 2 | Degeneration, Fatty | 2 1 2 | 26 1.7| Hyperplasia | 2 1 2 1 2 | 15 1.8| Infiltration Cellular, Lymphocyte | | 1 2.0| Necrosis | | 1 2.0| Pigmentation | 1 | 1 1.0| __________________________________________________________________________|____________| Adrenal Gland, Medulla | + + + + + + + + + + | 50 | Hyperplasia | 2 2 1 | 11 1.7| __________________________________________________________________________|____________| Islets, Pancreatic | + + + + + + + + + + | 50 | Hyperplasia | | 1 2.0| __________________________________________________________________________|____________| Parathyroid Gland | + + + + M + + + + + | 39 | Hypertrophy | 2 | 1 2.0| __________________________________________________________________________|____________| Pituitary Gland | + + + + + + + + + + | 50 | Pars Distalis, Cyst | | 3 | Pars Distalis, Hemorrhage | | 2 3.5| Pars Distalis, Hyperplasia | 2 2 | 10 2.0| Pars Distalis, Infarct | | 1 4.0| Pars Distalis, Infiltration Cellular,| | | Lymphocyte | | 1 2.0| __________________________________________________________________________|____________| Thyroid Gland | + + + + + + + + + + | 50 | Ultimobranchial Cyst | X | 2 | C-Cell, Hyperplasia | | 8 1.8| Follicle, Ectasia | 2 3 | 6 2.2| _____________________________________________________________________________________________________________________| | 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 54 NTP Experiment-Test: 05007-06 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 07:49:23 __________________________________________________________________________________________________________________________________ | 4| 4| 6| 7| 7| 6| 7| 7| 7| 7| | | DAY ON TEST | 5| 9| 4| 1| 3| 4| 1| 3| 3| 3| | | | 5| 3| 0| 7| 0| 0| 2| 0| 0| 0| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | 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 | | | | | | __________________________________________________________________________|____________| Epididymis | + + + + + + + + + + | 49 | Inflammation, Chronic | 2 | 4 2.0| Inflammation, Chronic Active | 1 | 1 1.0| __________________________________________________________________________|____________| Preputial Gland | + + + + + + + + + + | 48 | Abscess | | 1 4.0| Inflammation, Chronic | 2 2 2 2 | 19 2.1| Inflammation, Chronic Active | 2 3 | 13 2.5| Duct, Ectasia | | 1 2.0| __________________________________________________________________________|____________| Prostate | + + + + + + + + + + | 50 | Inflammation, Acute | 4 | 1 4.0| Inflammation, Chronic | 1 2 | 6 2.3| Inflammation, Chronic Active | 2 3 2 4 2 3 | 40 2.6| __________________________________________________________________________|____________| Seminal Vesicle | + + + + + + + + + + | 50 | __________________________________________________________________________|____________| Testes | + + + + + + + + + + | 49 | Atrophy | | 6 3.7| Necrosis | | 1 4.0| Interstitial Cell, Hyperplasia | 1 1 | 13 1.5| _____________________________________________________________________________________________________________________| | HEMATOPOIETIC SYSTEM | | | | | | __________________________________________________________________________|____________| Blood | | 2 | __________________________________________________________________________|____________| Bone Marrow | + + + + + + + + + + | 50 | Hemorrhage | | 1 3.0| Necrosis | | 1 3.0| __________________________________________________________________________|____________| Lymph Node | + M + + + + + + + + | 49 | Mediastinal, Congestion | | 1 2.0| Mediastinal, Hemorrhage | | 1 3.0| Mediastinal, Infiltration Cellular, | | | Plasma Cell | | 1 2.0| __________________________________________________________________________|____________| Lymph Node, Mandibular | + M + + + + + + + + | 49 | Congestion | 2 | 1 2.0| Cyst | X | 4 | Hyperplasia, Lymphoid | 2 2 2 3 2 2 | 37 2.2| __________________________________________________________________________|____________| Lymph Node, Mesenteric | + M + + + + + + + + | 49 | Congestion | 3 | 1 3.0| __________________________________________________________________________|____________| Spleen | + + + + + + + + + + | 50 | Fibrosis | 2 | 6 2.5| Hematopoietic Cell Proliferation | 2 1 1 2 2 | 30 1.6| Necrosis | | 2 2.5| Pigmentation | 2 3 2 3 3 2 2 | 25 2.3| __________________________________________________________________________________________________________________________________ * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 55 NTP Experiment-Test: 05007-06 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 07:49:23 __________________________________________________________________________________________________________________________________ | 4| 4| 6| 7| 7| 6| 7| 7| 7| 7| | | DAY ON TEST | 5| 9| 4| 1| 3| 4| 1| 3| 3| 3| | | | 5| 3| 0| 7| 0| 0| 2| 0| 0| 0| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | 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 | | | | | | __________________________________________________________________________|____________| Thymus | + + + + + + + + + + | 47 | Congestion | 3 | 1 3.0| _____________________________________________________________________________________________________________________| | INTEGUMENTARY SYSTEM | | | | | | __________________________________________________________________________|____________| Mammary Gland | + + + + + + + + + + | 47 | Acinus, Ectasia | 2 3 2 | 20 2.4| Acinus, Hyperplasia | | 2 2.0| Duct, Ectasia | 2 | 1 2.0| __________________________________________________________________________|____________| Skin | + + + + + + + + + + | 49 | Abscess | 3 | 2 3.5| _____________________________________________________________________________________________________________________| | MUSCULOSKELETAL SYSTEM | | | | | | __________________________________________________________________________|____________| Bone | + + + + + + + + + + | 50 | Cranium, Fibrous Osteodystrophy | | 1 2.0| Femur, Fibrous Osteodystrophy | | 3 2.0| Femur, Hyperostosis | | 1 2.0| _____________________________________________________________________________________________________________________| | NERVOUS SYSTEM | | | | | | __________________________________________________________________________|____________| Brain | + + + + + + + + + + | 50 | Compression | X | 5 2.3| Hemorrhage | | 2 2.0| Hydrocephalus | 2 | 1 2.0| _____________________________________________________________________________________________________________________| | RESPIRATORY SYSTEM | | | | | | __________________________________________________________________________|____________| Lung | + + + + + + + + + + | 50 | Congestion | 2 3 3 | 4 2.8| Hemorrhage | 2 2 1 | 5 1.6| Alveolar Epithelium, Hyperplasia | 3 2 | 2 2.5| Alveolus, Infiltration Cellular, | | | Histiocyte | 2 | 6 1.8| Arteriole, Mineralization | 2 1 2 2 2 2 | 31 1.9| Interstitium, Inflammation, Chronic | 1 | 1 1.0| __________________________________________________________________________|____________| Nose | + + + + + + + + + + | 50 | Lumen, Hemorrhage | 3 2 | 9 1.8| Mucosa, Inflammation, Acute | 2 4 2 | 12 2.6| Nasolacrimal Duct, Hemorrhage | | 3 2.0| Nasolacrimal Duct, Inflammation, | | | Acute | 2 2 | 14 1.6| Olfactory Epithelium, Degeneration | 1 2 2 1 1 1 | 32 1.7| __________________________________________________________________________________________________________________________________ * : 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 56 NTP Experiment-Test: 05007-06 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 07:49:23 __________________________________________________________________________________________________________________________________ | 4| 4| 6| 7| 7| 6| 7| 7| 7| 7| | | DAY ON TEST | 5| 9| 4| 1| 3| 4| 1| 3| 3| 3| | | | 5| 3| 0| 7| 0| 0| 2| 0| 0| 0| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | 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 | | | | | | Respiratory Epithelium, Degeneration | | 7 1.3| __________________________________________________________________________|____________| Trachea | + + + + + + + + + + | 50 | _____________________________________________________________________________________________________________________| | SPECIAL SENSES SYSTEM | | | | | | __________________________________________________________________________|____________| Ear | | 1 | Canal, Abscess | | 1 4.0| __________________________________________________________________________|____________| Eye | + + + | 10 | Cataract | 4 4 | 8 3.6| Hemorrhage | 3 | 3 3.3| Posterior Chamber, Synechia | | 1 4.0| Retina, Degeneration | 4 4 | 9 3.8| Sclera, Mineralization | | 2 2.5| __________________________________________________________________________|____________| Zymbal's Gland | + | 1 | _____________________________________________________________________________________________________________________| | URINARY SYSTEM | | | | | | __________________________________________________________________________|____________| Kidney | + + + + + + + + + + | 50 | Cyst | | 2 | Necrosis | | 1 4.0| Nephropathy, Chronic | 2 2 2 4 3 2 4 3 3 3 | 50 2.8| Renal Tubule, Mineralization | | 1 4.0| Renal Tubule, Pigmentation | 2 2 2 2 1 1 1 2 | 44 1.7| __________________________________________________________________________|____________| Urethra | + | 3 | Calculus Micro Observation Only | X | 3 | __________________________________________________________________________|____________| Urinary Bladder | + A + + + + + + + + | 49 | Calculus Micro Observation Only | | 1 | Infiltration Cellular, Lymphocyte | | 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 57 NTP Experiment-Test: 05007-06 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 07:49:23 _____________________________________________________________________________________________________________________ | 4| 6| 6| 7| 7| 4| 5| 7| 7| 7| 5| 6| 6| 6| 7| 4| 4| 4| 4| 4| 4| 6| 6| 6| 7| DAY ON TEST | 5| 8| 8| 3| 3| 5| 7| 0| 3| 3| 9| 4| 4| 6| 3| 6| 6| 6| 6| 6| 9| 4| 9| 9| 3| | 4| 2| 8| 0| 0| 8| 5| 1| 0| 0| 7| 6| 6| 8| 0| 2| 2| 2| 2| 2| 4| 7| 9| 9| 0| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 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 | + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Large | + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Large, Cecum | + + + + + + + + + + + + + + + + + + + +| Parasite Metazoan | X X | __________________________________________________________________________| Intestine Large, Colon | + + + + + + + + + + + + + + + + + + + +| Parasite Metazoan | X | Arteriole, Inflammation, Chronic | | __________________________________________________________________________| Intestine Large, Rectum | + + + + + + + + + + + + + + + + + + + +| Parasite Metazoan | X | __________________________________________________________________________| Intestine Small | + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Small, Duodenum | + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Small, Ileum | + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Small, Jejunum | + + + + + + + + + + + + + + + + + + + +| Inflammation, Chronic Active | 3 | __________________________________________________________________________| Liver | + + + + + + + + + + + + + + + + + + + +| Angiectasis | 1 1 2 | Basophilic Focus | X X X X X X X X X X X X| Congestion | | Developmental Malformation | | Granuloma | 1 | Necrosis | 1 | Vacuolization Cytoplasmic | | Arteriole, Inflammation, Chronic | | Bile Duct, Hyperplasia | 2 2 2 2 2 2 2 4 2 2 2 2 3 1 1 2 2 2 1 2| Portal, Inflammation, Chronic | 2 2 2 1 2 2 2 2 2 2 2 2 2 2 2 2 2| __________________________________________________________________________| Mesentery | + + + + + + | Artery, Inflammation, Chronic | | Fat, Necrosis | 3 4 4 3 | __________________________________________________________________________| Pancreas | + + + + + + + + + + + + + + + M + + + +| Infiltration Cellular, Lymphocyte | 2 | Inflammation, Acute | | Pigmentation | | Acinus, Atrophy | 2 1 2 2 2 2 2 2 2 2| Artery, Inflammation, Chronic | | __________________________________________________________________________| Salivary Glands | + + + + + + + + + + + + + + + + + + + +| Infiltration Cellular, Lymphocyte | 1 | Acinus, Atrophy | | Duct, Mineralization | | __________________________________________________________________________| Stomach | + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Stomach, Forestomach | + + + + + + + + + + + + + + + + + + + +| Hyperkeratosis | | Inflammation, Acute | | __________________________________________________________________________| Stomach, Glandular | + + + + + + + + + + + + + + + + + + + +| Mineralization | | _____________________________________________________________________________________________________________________| Page 58 NTP Experiment-Test: 05007-06 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 07:49:23 _____________________________________________________________________________________________________________________ | 4| 6| 6| 7| 7| 4| 5| 7| 7| 7| 5| 6| 6| 6| 7| 4| 4| 4| 4| 4| 4| 6| 6| 6| 7| DAY ON TEST | 5| 8| 8| 3| 3| 5| 7| 0| 3| 3| 9| 4| 4| 6| 3| 6| 6| 6| 6| 6| 9| 4| 9| 9| 3| | 4| 2| 8| 0| 0| 8| 5| 1| 0| 0| 7| 6| 6| 8| 0| 2| 2| 2| 2| 2| 4| 7| 9| 9| 0| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 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 | | | | Mucosa, Dilatation | 2 2 2 2 2 2 2 2 2 2 | Mucosa, Erosion | 2 | Mucosa, Ulcer | | __________________________________________________________________________| Tooth | + + + | Peridontal Tissue, Hemorrhage | | Peridontal Tissue, Inflammation, | | Chronic | 3 | Pulp, Necrosis | 4 | _____________________________________________________________________________________________________________________| CARDIOVASCULAR SYSTEM | | | | __________________________________________________________________________| Blood Vessel | | Artery, Inflammation, Chronic | | Artery, Thrombosis | | __________________________________________________________________________| Heart | + + + + + + + + + + + + + + + + + + + +| Cardiomyopathy, Chronic | 2 2 3 2 3 2 3 4 2 2 2 2 1 3 1 3 2 3| Mineralization | | Artery, Inflammation, Chronic | | Artery, Mineralization | | Atrium Left, Thrombosis | X| _____________________________________________________________________________________________________________________| ENDOCRINE SYSTEM | | | | __________________________________________________________________________| Adrenal Gland | + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Adrenal Gland, Cortex | + + + + + + + + + + + + + + + + + + + +| Accessory Adrenal Cortical Nodule | X | Cyst | X | Degeneration, Fatty | 2 2 2 2 1 2 1 2 2 1 2 2 2 | Hyperplasia | 2 2 2 1 2 2 2 1| Hypertrophy | | Necrosis | | Pigmentation | | __________________________________________________________________________| Adrenal Gland, Medulla | + + + + + + + + + + + + + + + + + + + +| Cyst | | Hyperplasia | 2 1 1 3 2 | __________________________________________________________________________| Islets, Pancreatic | + + + + + + + + + + + + + + + M + + + +| Hyperplasia | | __________________________________________________________________________| Parathyroid Gland | + + + + + + + + + + M + + + + + + + + +| Hypertrophy | 2 2 | __________________________________________________________________________| Pituitary Gland | + + + + + + + + + + + + + + + + + + + +| Pars Distalis, Cyst | X X | Pars Distalis, Hyperplasia | 2 2 2 | Pars Intermedia, Angiectasis | 2 | Pars Intermedia, Cyst | X | Pars Intermedia, Hyperplasia | | __________________________________________________________________________| Thyroid Gland | + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| Page 59 NTP Experiment-Test: 05007-06 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 07:49:23 _____________________________________________________________________________________________________________________ | 4| 6| 6| 7| 7| 4| 5| 7| 7| 7| 5| 6| 6| 6| 7| 4| 4| 4| 4| 4| 4| 6| 6| 6| 7| DAY ON TEST | 5| 8| 8| 3| 3| 5| 7| 0| 3| 3| 9| 4| 4| 6| 3| 6| 6| 6| 6| 6| 9| 4| 9| 9| 3| | 4| 2| 8| 0| 0| 8| 5| 1| 0| 0| 7| 6| 6| 8| 0| 2| 2| 2| 2| 2| 4| 7| 9| 9| 0| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 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| _____________________________________________________________________________________________________________________| ENDOCRINE SYSTEM - cont | | | | Hemorrhage | | Infiltration Cellular, Lymphocyte | | Ultimobranchial Cyst | X | C-Cell, Hyperplasia | 2 2 2 2 1 1 1| Follicle, Ectasia | 2 | Follicle, Hyperplasia | 2 | _____________________________________________________________________________________________________________________| GENERAL BODY SYSTEM | | | | None | | _____________________________________________________________________________________________________________________| GENITAL SYSTEM | | | | __________________________________________________________________________| Epididymis | + + + + + + + + + + + + + + + + + + + +| Inflammation, Chronic Active | 3 | __________________________________________________________________________| Preputial Gland | + + + + + + + + + + + + + + + + + + + +| Inflammation, Chronic | 3 1 2 2 2 2 2 2 | Inflammation, Chronic Active | 3 2 2| Duct, Ectasia | | __________________________________________________________________________| Prostate | + + + + + + + + + + + + + + + + + + + +| Hemorrhage | | Inflammation, Acute | | Inflammation, Chronic | 1 2 | Inflammation, Chronic Active | 3 3 3 3 3 2 3 3 3 4 2 3 2 2 | __________________________________________________________________________| Seminal Vesicle | + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Testes | + + + + + + + + + + + + + + + + + + + +| Mineralization | | Artery, Inflammation, Chronic | 2 | Interstitial Cell, Hyperplasia | 1 1 1 3 3 1 1 1 | _____________________________________________________________________________________________________________________| HEMATOPOIETIC SYSTEM | | | | __________________________________________________________________________| Blood | + | __________________________________________________________________________| Bone Marrow | + + + + + + + + + + + + + + + + + + + +| Hemorrhage | 4 | Myelofibrosis | | __________________________________________________________________________| Lymph Node | + + + + + + + + + + + + + + + + + + + +| Mediastinal, Congestion | 3 2| Mediastinal, Hemorrhage | | Mediastinal, Infiltration Cellular, | | Plasma Cell | | Pancreatic, Congestion | | __________________________________________________________________________| Lymph Node, Mandibular | M + + + + + + + + + + + + + + + + + + +| Congestion | | Cyst | X X X | Hyperplasia, Lymphoid | 2 2 2 2 3 3 2 2 2 2 2 3 2 2 3 2 2| Inflammation, Acute | 3 | _____________________________________________________________________________________________________________________| Page 60 NTP Experiment-Test: 05007-06 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 07:49:23 _____________________________________________________________________________________________________________________ | 4| 6| 6| 7| 7| 4| 5| 7| 7| 7| 5| 6| 6| 6| 7| 4| 4| 4| 4| 4| 4| 6| 6| 6| 7| DAY ON TEST | 5| 8| 8| 3| 3| 5| 7| 0| 3| 3| 9| 4| 4| 6| 3| 6| 6| 6| 6| 6| 9| 4| 9| 9| 3| | 4| 2| 8| 0| 0| 8| 5| 1| 0| 0| 7| 6| 6| 8| 0| 2| 2| 2| 2| 2| 4| 7| 9| 9| 0| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 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 | | | | __________________________________________________________________________| Lymph Node, Mesenteric | + + + + + + + + + + + + + + + + + + + +| Congestion | 2 | Edema | | Hemorrhage | | Hyperplasia, Lymphoid | | __________________________________________________________________________| Spleen | + + + + + + + + + + + + + + + + + + + +| Fibrosis | 3 | Hematopoietic Cell Proliferation | 3 2 3 2 3 3 2 3 3 1 2 2 1 3 2| Hyperplasia, Lymphoid | 2 2 | Pigmentation | 3 2 2 2 3 3 2 | __________________________________________________________________________| Thymus | M + + + + + + + + + + + + + + + + + + +| Congestion | | Cyst | | Hyperplasia, Lymphoid | | _____________________________________________________________________________________________________________________| INTEGUMENTARY SYSTEM | | | | __________________________________________________________________________| Mammary Gland | + + + + + + + + + + + + + + + M + + + +| Acinus, Ectasia | 2 3 2 2 2 2 | Duct, Ectasia | | __________________________________________________________________________| Skin | + + + + + + + + + + + + + + + + + + + +| Alopecia | | Cyst Epithelial Inclusion | | Hyperkeratosis | | Inflammation, Chronic Active | | Ulcer | 4 | _____________________________________________________________________________________________________________________| MUSCULOSKELETAL SYSTEM | | | | __________________________________________________________________________| Bone | + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| NERVOUS SYSTEM | | | | __________________________________________________________________________| Brain | + + + + + + + + + + + + + + + + + + + +| Compression | X 2 | Hemorrhage | 2 | Hydrocephalus | 2 | _____________________________________________________________________________________________________________________| RESPIRATORY SYSTEM | | | | __________________________________________________________________________| Lung | + + + + + + + + + + + + + + + + + + + +| Congestion | | Hemorrhage | 2 1 2 2 | Alveolus, Infiltration Cellular, | | Histiocyte | 2 2 1 1 2 2| Alveolus, Mineralization | | Arteriole, Mineralization | 2 1 2 2 2 2 2 1 2 2 2 2 2 2 2| Bronchiole, Inflammation, Acute | 1 | _____________________________________________________________________________________________________________________| Page 61 NTP Experiment-Test: 05007-06 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 07:49:23 _____________________________________________________________________________________________________________________ | 4| 6| 6| 7| 7| 4| 5| 7| 7| 7| 5| 6| 6| 6| 7| 4| 4| 4| 4| 4| 4| 6| 6| 6| 7| DAY ON TEST | 5| 8| 8| 3| 3| 5| 7| 0| 3| 3| 9| 4| 4| 6| 3| 6| 6| 6| 6| 6| 9| 4| 9| 9| 3| | 4| 2| 8| 0| 0| 8| 5| 1| 0| 0| 7| 6| 6| 8| 0| 2| 2| 2| 2| 2| 4| 7| 9| 9| 0| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 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 | | | | Interstitium, Inflammation, Chronic | | Interstitium, Inflammation, Chronic | | Active | | Peribronchiolar, Inflammation, | | Chronic Active | 3| __________________________________________________________________________| Nose | + + + + + + + + + + + + + + + + + + + +| Lumen, Hemorrhage | 1 1 1 | Mucosa, Inflammation, Acute | 3 4 2 | Mucosa, Inflammation, Chronic | 2 | Nasolacrimal Duct, Hemorrhage | | Nasolacrimal Duct, Inflammation, | | Acute | 2 3 2 | Olfactory Epithelium, Degeneration | 2 2 1 2 1 2 2 2 2 2 2 2| Respiratory Epithelium, Degeneration | 2 1 1 1 2 | Respiratory Epithelium, Metaplasia, | | Squamous | | __________________________________________________________________________| Trachea | + + + + + + + + + + + + + + + + + + + +| Inflammation, Acute | | _____________________________________________________________________________________________________________________| SPECIAL SENSES SYSTEM | | | | __________________________________________________________________________| Ear | + + | __________________________________________________________________________| Eye | + + + + | Cataract | 4 3 4 | Hemorrhage | | Inflammation, Chronic | | Anterior Chamber, Hemorrhage | 3 | Cornea, Inflammation, Acute | 4 | Posterior Chamber, Synechia | | Retina, Degeneration | 4 4 4 | Sclera, Mineralization | | _____________________________________________________________________________________________________________________| URINARY SYSTEM | | | | __________________________________________________________________________| Kidney | + + + + + + + + + + + + + + + + + + + +| Congestion | | Cyst | X | Infarct | | Nephropathy, Chronic | 2 3 4 4 4 1 2 3 4 4 2 2 3 4 3 2 3 3 3 3| Cortex, Cyst | X | Renal Tubule, Pigmentation | 2 1 1 1 1 2 1 1 2 1 1 1 1 1 2 2 2| __________________________________________________________________________| Urethra | + + | Calculus Micro Observation Only | X X | __________________________________________________________________________| Urinary Bladder | + + + + + + + + + + + + + + + + + + + +| Calculus Micro Observation Only | | _____________________________________________________________________________________________________________________| Page 62 NTP Experiment-Test: 05007-06 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 07:49:23 _____________________________________________________________________________________________________________________ | 4| 6| 6| 7| 7| 6| 6| 7| 7| 7| 4| 5| 5| 7| 7| 4| 4| 4| 4| 4| 5| 6| 7| 7| 7| DAY ON TEST | 0| 9| 9| 3| 3| 4| 8| 2| 3| 3| 6| 0| 7| 1| 3| 6| 6| 6| 6| 6| 7| 2| 0| 3| 3| | 0| 9| 9| 1| 1| 4| 9| 4| 1| 1| 1| 3| 4| 0| 1| 2| 2| 2| 2| 2| 0| 5| 9| 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| FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 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 | + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Large | + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Large, Cecum | + + + + + + + + + M + + + + + + + + + +| Parasite Metazoan | X X X | __________________________________________________________________________| Intestine Large, Colon | + + + + + + + + + + + + + + + + + + + +| Parasite Metazoan | | Arteriole, Inflammation, Chronic | 3 | __________________________________________________________________________| Intestine Large, Rectum | + + + + + + + + + + + + + + + + + + + +| Parasite Metazoan | X| __________________________________________________________________________| Intestine Small | + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Small, Duodenum | + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Small, Ileum | + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Small, Jejunum | + + + + + + + + + + + + + + + + + + + +| Inflammation, Chronic Active | | __________________________________________________________________________| Liver | + + + + + + + + + + + + + + + + + + + +| Angiectasis | 2 2 2 | Basophilic Focus | X X X X X X X X X X| Congestion | 2 | Developmental Malformation | X | Granuloma | | Necrosis | 1 | Vacuolization Cytoplasmic | 2 | Arteriole, Inflammation, Chronic | 3 | Bile Duct, Hyperplasia | 2 2 2 2 2 4 2 3 2 2 2 2 3 2 2 2 2 2 2 3| Portal, Inflammation, Chronic | 2 2 2 2 2 1 2 2 2 1 2 2 2 2 2 2 2 2 2| __________________________________________________________________________| Mesentery | + + + + | Artery, Inflammation, Chronic | 4 | Fat, Necrosis | 4 4 | __________________________________________________________________________| Pancreas | A + + + + + + + + + + + + + + + + + + +| Infiltration Cellular, Lymphocyte | | Inflammation, Acute | | Pigmentation | 2 | Acinus, Atrophy | 1 2 3 2 2 3 1 1 | Artery, Inflammation, Chronic | | __________________________________________________________________________| Salivary Glands | + + + + + + + + + + + + + + + + + + + +| Infiltration Cellular, Lymphocyte | | Acinus, Atrophy | | Duct, Mineralization | 2 | __________________________________________________________________________| Stomach | + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Stomach, Forestomach | + + + + + + + + + + + + + + + + + + + +| Hyperkeratosis | 3 | Inflammation, Acute | 2 | __________________________________________________________________________| Stomach, Glandular | + + + + + + + + + + + + + + + + + + + +| Mineralization | 2 | _____________________________________________________________________________________________________________________| Page 63 NTP Experiment-Test: 05007-06 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 07:49:23 _____________________________________________________________________________________________________________________ | 4| 6| 6| 7| 7| 6| 6| 7| 7| 7| 4| 5| 5| 7| 7| 4| 4| 4| 4| 4| 5| 6| 7| 7| 7| DAY ON TEST | 0| 9| 9| 3| 3| 4| 8| 2| 3| 3| 6| 0| 7| 1| 3| 6| 6| 6| 6| 6| 7| 2| 0| 3| 3| | 0| 9| 9| 1| 1| 4| 9| 4| 1| 1| 1| 3| 4| 0| 1| 2| 2| 2| 2| 2| 0| 5| 9| 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| FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 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 | | | | Mucosa, Dilatation | 2 2 2 2 2 2 2 2| Mucosa, Erosion | | Mucosa, Ulcer | 3 | __________________________________________________________________________| Tooth | + | Peridontal Tissue, Hemorrhage | 2 | Peridontal Tissue, Inflammation, | | Chronic | | Pulp, Necrosis | | _____________________________________________________________________________________________________________________| CARDIOVASCULAR SYSTEM | | | | __________________________________________________________________________| Blood Vessel | + | Artery, Inflammation, Chronic | 4 | Artery, Thrombosis | X | __________________________________________________________________________| Heart | + + + + + + + + + + + + + + + + + + + +| Cardiomyopathy, Chronic | 2 2 1 2 3 2 3 3 2 2 2 2 3 3 2 2 2 3| Mineralization | 2 | Artery, Inflammation, Chronic | | Artery, Mineralization | 1 | Atrium Left, Thrombosis | X | _____________________________________________________________________________________________________________________| ENDOCRINE SYSTEM | | | | __________________________________________________________________________| Adrenal Gland | + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Adrenal Gland, Cortex | + + + + + + + + + + + + + + + + + + + +| Accessory Adrenal Cortical Nodule | | Cyst | | Degeneration, Fatty | 2 2 1 1 2 2 2 1 2 2 | Hyperplasia | 2 2 2 2 2| Hypertrophy | 2 | Necrosis | 4 | Pigmentation | | __________________________________________________________________________| Adrenal Gland, Medulla | + + + + + + + + + + + + + + + + + + + +| Cyst | | Hyperplasia | 2 2 2 2 1 2 | __________________________________________________________________________| Islets, Pancreatic | A + + + + + + + + + + + + + + + + + + +| Hyperplasia | 2 | __________________________________________________________________________| Parathyroid Gland | + + + + + + + + + + + + + + + + + M + +| Hypertrophy | 2 | __________________________________________________________________________| Pituitary Gland | + + + + + + + + + + + + + + + + + + + +| Pars Distalis, Cyst | | Pars Distalis, Hyperplasia | 2 2 2 2 2 2 2 2| Pars Intermedia, Angiectasis | | Pars Intermedia, Cyst | | Pars Intermedia, Hyperplasia | | __________________________________________________________________________| Thyroid Gland | + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| Page 64 NTP Experiment-Test: 05007-06 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 07:49:23 _____________________________________________________________________________________________________________________ | 4| 6| 6| 7| 7| 6| 6| 7| 7| 7| 4| 5| 5| 7| 7| 4| 4| 4| 4| 4| 5| 6| 7| 7| 7| DAY ON TEST | 0| 9| 9| 3| 3| 4| 8| 2| 3| 3| 6| 0| 7| 1| 3| 6| 6| 6| 6| 6| 7| 2| 0| 3| 3| | 0| 9| 9| 1| 1| 4| 9| 4| 1| 1| 1| 3| 4| 0| 1| 2| 2| 2| 2| 2| 0| 5| 9| 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| FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 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| _____________________________________________________________________________________________________________________| ENDOCRINE SYSTEM - cont | | | | Hemorrhage | 2 | Infiltration Cellular, Lymphocyte | 2 | Ultimobranchial Cyst | | C-Cell, Hyperplasia | 2 2 2 2 2| Follicle, Ectasia | 2 | Follicle, Hyperplasia | | _____________________________________________________________________________________________________________________| GENERAL BODY SYSTEM | | | | None | | _____________________________________________________________________________________________________________________| GENITAL SYSTEM | | | | __________________________________________________________________________| Epididymis | + + + + + + + + + + + + + + + + + + + +| Inflammation, Chronic Active | | __________________________________________________________________________| Preputial Gland | + + + + + M + + + + + + + + + + + + + +| Inflammation, Chronic | 2 2 2 2 2 3 2 2 2 | Inflammation, Chronic Active | 3 3 2 3 2 3 | Duct, Ectasia | 3 2 | __________________________________________________________________________| Prostate | + + + + + + + + + + + + + + + + + + + +| Hemorrhage | 2 | Inflammation, Acute | 4 | Inflammation, Chronic | 1 1 2 | Inflammation, Chronic Active | 2 2 3 4 4 2 4 2 4 3 3 | __________________________________________________________________________| Seminal Vesicle | + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Testes | + + + + + + + + + + + + + + + + + + + +| Mineralization | 2 | Artery, Inflammation, Chronic | 2 | Interstitial Cell, Hyperplasia | 1 1 1 2 | _____________________________________________________________________________________________________________________| HEMATOPOIETIC SYSTEM | | | | __________________________________________________________________________| Blood | | __________________________________________________________________________| Bone Marrow | + + + + + + + + + + + + + + + + + + + +| Hemorrhage | | Myelofibrosis | | __________________________________________________________________________| Lymph Node | + + + + + + + + + + + + + + + + + + + +| Mediastinal, Congestion | | Mediastinal, Hemorrhage | | Mediastinal, Infiltration Cellular, | | Plasma Cell | 2 | Pancreatic, Congestion | | __________________________________________________________________________| Lymph Node, Mandibular | + + + + + + + + + + M + + + + + + + + +| Congestion | | Cyst | X| Hyperplasia, Lymphoid | 2 2 2 2 3 2 2 2 2 3 2 2 2 3 3| Inflammation, Acute | | _____________________________________________________________________________________________________________________| Page 65 NTP Experiment-Test: 05007-06 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 07:49:23 _____________________________________________________________________________________________________________________ | 4| 6| 6| 7| 7| 6| 6| 7| 7| 7| 4| 5| 5| 7| 7| 4| 4| 4| 4| 4| 5| 6| 7| 7| 7| DAY ON TEST | 0| 9| 9| 3| 3| 4| 8| 2| 3| 3| 6| 0| 7| 1| 3| 6| 6| 6| 6| 6| 7| 2| 0| 3| 3| | 0| 9| 9| 1| 1| 4| 9| 4| 1| 1| 1| 3| 4| 0| 1| 2| 2| 2| 2| 2| 0| 5| 9| 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| FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 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 | | | | __________________________________________________________________________| Lymph Node, Mesenteric | + + + + + + + + + + + + + + + + + + + | Congestion | | Edema | 3 | Hemorrhage | | Hyperplasia, Lymphoid | 4 | __________________________________________________________________________| Spleen | + + + + + + + + + + + + + + + + + + + +| Fibrosis | 3 | Hematopoietic Cell Proliferation | 3 1 2 2 3 1 2 1 4 4 2 3 2 2| Hyperplasia, Lymphoid | 2 | Pigmentation | 2 3 2 2 2 2 2 3 2 2| __________________________________________________________________________| Thymus | + + + + + + + + + + + + + + + + + + + +| Congestion | 2 | Cyst | X | Hyperplasia, Lymphoid | 2 | _____________________________________________________________________________________________________________________| INTEGUMENTARY SYSTEM | | | | __________________________________________________________________________| Mammary Gland | + + + + + + + + M + + + + + + + + + + +| Acinus, Ectasia | 2 2 2 2 4 4 | Duct, Ectasia | 2 | __________________________________________________________________________| Skin | + + + + + + + + + + + + + + + + + + + +| Alopecia | X | Cyst Epithelial Inclusion | X | Hyperkeratosis | 4 | Inflammation, Chronic Active | 2 | Ulcer | | _____________________________________________________________________________________________________________________| MUSCULOSKELETAL SYSTEM | | | | __________________________________________________________________________| Bone | + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| NERVOUS SYSTEM | | | | __________________________________________________________________________| Brain | + + + + + + + + + + + + + + + + + + + +| Compression | 2 X X | Hemorrhage | | Hydrocephalus | | _____________________________________________________________________________________________________________________| RESPIRATORY SYSTEM | | | | __________________________________________________________________________| Lung | + + + + + + + + + + + + + + + + + + + +| Congestion | 3 3 | Hemorrhage | 2 3 2 | Alveolus, Infiltration Cellular, | | Histiocyte | 2 2 1 2 2 | Alveolus, Mineralization | 2 1 | Arteriole, Mineralization | 2 2 2 2 2 2 1 2 2 2 2 1 2| Bronchiole, Inflammation, Acute | | _____________________________________________________________________________________________________________________| Page 66 NTP Experiment-Test: 05007-06 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 07:49:23 _____________________________________________________________________________________________________________________ | 4| 6| 6| 7| 7| 6| 6| 7| 7| 7| 4| 5| 5| 7| 7| 4| 4| 4| 4| 4| 5| 6| 7| 7| 7| DAY ON TEST | 0| 9| 9| 3| 3| 4| 8| 2| 3| 3| 6| 0| 7| 1| 3| 6| 6| 6| 6| 6| 7| 2| 0| 3| 3| | 0| 9| 9| 1| 1| 4| 9| 4| 1| 1| 1| 3| 4| 0| 1| 2| 2| 2| 2| 2| 0| 5| 9| 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| FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 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 | | | | Interstitium, Inflammation, Chronic | 2 | Interstitium, Inflammation, Chronic | | Active | 3 | Peribronchiolar, Inflammation, | | Chronic Active | | __________________________________________________________________________| Nose | + + + + + + + + + + + + + + + + + + + +| Lumen, Hemorrhage | 2 1 2 | Mucosa, Inflammation, Acute | 4 2 3 | Mucosa, Inflammation, Chronic | 2 | Nasolacrimal Duct, Hemorrhage | 2 | Nasolacrimal Duct, Inflammation, | | Acute | 2 4 2 2 2| Olfactory Epithelium, Degeneration | 1 2 1 2 2 2 2 2 2 2 2 1 2 2 2 2 2| Respiratory Epithelium, Degeneration | 1 1 | Respiratory Epithelium, Metaplasia, | | Squamous | 4 | __________________________________________________________________________| Trachea | + + + + + + + + + + + + + + + + + + + +| Inflammation, Acute | 3 | _____________________________________________________________________________________________________________________| SPECIAL SENSES SYSTEM | | | | __________________________________________________________________________| Ear | | __________________________________________________________________________| Eye | + + + + + +| Cataract | 2 4 4 4 4| Hemorrhage | 4 3 | Inflammation, Chronic | 4 | Anterior Chamber, Hemorrhage | | Cornea, Inflammation, Acute | | Posterior Chamber, Synechia | 3 | Retina, Degeneration | 4 4 4 4 4| Sclera, Mineralization | 2 | _____________________________________________________________________________________________________________________| URINARY SYSTEM | | | | __________________________________________________________________________| Kidney | + + + + + + + + + + + + + + + + + + + +| Congestion | | Cyst | | Infarct | 4 | Nephropathy, Chronic | 2 3 3 2 4 3 4 3 3 4 2 2 1 4 3 4 2 2 4 3| Cortex, Cyst | | Renal Tubule, Pigmentation | 2 3 2 1 2 2 2 2 1 2 2 2 1 4 2 2| __________________________________________________________________________| Urethra | + | Calculus Micro Observation Only | X | __________________________________________________________________________| Urinary Bladder | + + + + + + + + + + + + + + + + + + + +| Calculus Micro Observation Only | X | _____________________________________________________________________________________________________________________| Page 67 NTP Experiment-Test: 05007-06 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 07:49:23 __________________________________________________________________________________________________________________________________ | 6| 7| 7| 7| 7| 2| 6| 6| 7| 7| | | DAY ON TEST | 3| 0| 3| 3| 3| 5| 8| 7| 3| 3| | | | 7| 0| 1| 1| 1| 8| 2| 9| 1| 1| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | 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 | + + + + + + + + + + | 50 | __________________________________________________________________________|____________| Intestine Large | + + + + + A + + + + | 49 | __________________________________________________________________________|____________| Intestine Large, Cecum | + + + + + A + + + + | 48 | Parasite Metazoan | | 5 | __________________________________________________________________________|____________| Intestine Large, Colon | + + + + + A + + + + | 49 | Parasite Metazoan | X X | 3 | Arteriole, Inflammation, Chronic | | 1 3.0| __________________________________________________________________________|____________| Intestine Large, Rectum | + + + + + A + + + + | 49 | Parasite Metazoan | | 2 | __________________________________________________________________________|____________| Intestine Small | + + + + + A + + + + | 49 | __________________________________________________________________________|____________| Intestine Small, Duodenum | + + + + + A + + + + | 49 | __________________________________________________________________________|____________| Intestine Small, Ileum | + + + + + A + + + + | 49 | __________________________________________________________________________|____________| Intestine Small, Jejunum | + + + + + A + + + + | 49 | Inflammation, Chronic Active | | 1 3.0| __________________________________________________________________________|____________| Liver | + + + + + + + + + + | 50 | Angiectasis | | 6 1.7| Basophilic Focus | X X X | 25 | Congestion | | 1 2.0| Developmental Malformation | X X | 3 | Granuloma | | 1 1.0| Necrosis | 2 | 3 1.3| Vacuolization Cytoplasmic | 2 | 2 2.0| Arteriole, Inflammation, Chronic | | 1 3.0| Bile Duct, Hyperplasia | 2 3 2 2 2 2 2 4 2 2 | 50 2.2| Portal, Inflammation, Chronic | 2 1 2 1 2 2 3 2 2 | 45 1.9| __________________________________________________________________________|____________| Mesentery | + + | 12 | Artery, Inflammation, Chronic | | 1 4.0| Fat, Necrosis | 4 4 | 8 3.8| __________________________________________________________________________|____________| Pancreas | + + + + + + + + + + | 48 | Infiltration Cellular, Lymphocyte | | 1 2.0| Inflammation, Acute | 4 | 1 4.0| Pigmentation | | 1 2.0| Acinus, Atrophy | 2 2 3 4 2 | 23 2.0| Artery, Inflammation, Chronic | 3 3 | 2 3.0| __________________________________________________________________________|____________| Salivary Glands | + + + + + + + + + + | 50 | Infiltration Cellular, Lymphocyte | | 1 1.0| Acinus, Atrophy | 2 | 1 2.0| Duct, Mineralization | | 1 2.0| __________________________________________________________________________|____________| Stomach | + + + + + + + + + + | 50 | __________________________________________________________________________________________________________________________________ * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 68 NTP Experiment-Test: 05007-06 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 07:49:23 __________________________________________________________________________________________________________________________________ | 6| 7| 7| 7| 7| 2| 6| 6| 7| 7| | | DAY ON TEST | 3| 0| 3| 3| 3| 5| 8| 7| 3| 3| | | | 7| 0| 1| 1| 1| 8| 2| 9| 1| 1| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | 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 | | | | | | __________________________________________________________________________|____________| Stomach, Forestomach | + + + + + + + + + + | 50 | Hyperkeratosis | | 1 3.0| Inflammation, Acute | | 1 2.0| __________________________________________________________________________|____________| Stomach, Glandular | + + + + + + + + + + | 50 | Mineralization | | 1 2.0| Mucosa, Dilatation | 1 2 2 1 2 2 | 24 1.9| Mucosa, Erosion | | 1 2.0| Mucosa, Ulcer | | 1 3.0| __________________________________________________________________________|____________| Tooth | | 4 | Peridontal Tissue, Hemorrhage | | 1 2.0| Peridontal Tissue, Inflammation, | | | Chronic | | 1 3.0| Pulp, Necrosis | | 1 4.0| _____________________________________________________________________________________________________________________| | CARDIOVASCULAR SYSTEM | | | | | | __________________________________________________________________________|____________| Blood Vessel | | 1 | Artery, Inflammation, Chronic | | 1 4.0| Artery, Thrombosis | | 1 | __________________________________________________________________________|____________| Heart | + + + + + + + + + + | 50 | Cardiomyopathy, Chronic | 2 3 3 2 2 2 2 3 3 | 45 2.3| Mineralization | | 1 2.0| Artery, Inflammation, Chronic | 3 | 1 3.0| Artery, Mineralization | 2 | 2 1.5| Atrium Left, Thrombosis | | 2 | _____________________________________________________________________________________________________________________| | ENDOCRINE SYSTEM | | | | | | __________________________________________________________________________|____________| Adrenal Gland | + + + + + + + + + + | 50 | __________________________________________________________________________|____________| Adrenal Gland, Cortex | + + + + + + + + + + | 50 | Accessory Adrenal Cortical Nodule | X | 2 | Cyst | | 1 | Degeneration, Fatty | 2 3 2 1 | 27 1.8| Hyperplasia | 2 | 14 1.9| Hypertrophy | | 1 2.0| Necrosis | | 1 4.0| Pigmentation | 1 2 2 2 2 2 | 6 1.8| __________________________________________________________________________|____________| Adrenal Gland, Medulla | + + + + + + + + + + | 50 | Cyst | X | 1 | Hyperplasia | 2 | 12 1.8| __________________________________________________________________________|____________| Islets, Pancreatic | + + + + + + + + + + | 48 | __________________________________________________________________________________________________________________________________ * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 69 NTP Experiment-Test: 05007-06 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 07:49:23 __________________________________________________________________________________________________________________________________ | 6| 7| 7| 7| 7| 2| 6| 6| 7| 7| | | DAY ON TEST | 3| 0| 3| 3| 3| 5| 8| 7| 3| 3| | | | 7| 0| 1| 1| 1| 8| 2| 9| 1| 1| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | 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 | | | | | | Hyperplasia | | 1 2.0| __________________________________________________________________________|____________| Parathyroid Gland | + M + M + + + + M + | 45 | Hypertrophy | | 3 2.0| __________________________________________________________________________|____________| Pituitary Gland | + + + + + + + + + + | 50 | Pars Distalis, Cyst | | 2 | Pars Distalis, Hyperplasia | 2 | 12 2.0| Pars Intermedia, Angiectasis | | 1 2.0| Pars Intermedia, Cyst | X | 2 | Pars Intermedia, Hyperplasia | 2 | 1 2.0| __________________________________________________________________________|____________| Thyroid Gland | + + + + + + + + + + | 50 | Hemorrhage | | 1 2.0| Infiltration Cellular, Lymphocyte | | 1 2.0| Ultimobranchial Cyst | X | 2 | C-Cell, Hyperplasia | | 12 1.8| Follicle, Ectasia | | 2 2.0| Follicle, Hyperplasia | | 1 2.0| _____________________________________________________________________________________________________________________| | GENERAL BODY SYSTEM | | | | | | None | | | _____________________________________________________________________________________________________________________| | GENITAL SYSTEM | | | | | | __________________________________________________________________________|____________| Epididymis | + + + + + + + + + + | 50 | Inflammation, Chronic Active | | 1 3.0| __________________________________________________________________________|____________| Preputial Gland | + + + + + + + + + + | 49 | Inflammation, Chronic | 2 3 2 | 20 2.1| Inflammation, Chronic Active | 3 3 2 3 3 | 14 2.6| Duct, Ectasia | | 2 2.5| __________________________________________________________________________|____________| Prostate | + + + + + + + + + + | 50 | Hemorrhage | | 1 2.0| Inflammation, Acute | | 1 4.0| Inflammation, Chronic | 1 | 6 1.3| Inflammation, Chronic Active | 3 2 3 4 4 3 2 | 32 2.9| __________________________________________________________________________|____________| Seminal Vesicle | + + + + + + + + + + | 50 | __________________________________________________________________________|____________| Testes | + + + + + + + + + + | 50 | Mineralization | | 1 2.0| Artery, Inflammation, Chronic | | 2 2.0| Interstitial Cell, Hyperplasia | 1 2 | 14 1.4| _____________________________________________________________________________________________________________________| | HEMATOPOIETIC SYSTEM | | | | | | __________________________________________________________________________________________________________________________________ * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 70 NTP Experiment-Test: 05007-06 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 07:49:23 __________________________________________________________________________________________________________________________________ | 6| 7| 7| 7| 7| 2| 6| 6| 7| 7| | | DAY ON TEST | 3| 0| 3| 3| 3| 5| 8| 7| 3| 3| | | | 7| 0| 1| 1| 1| 8| 2| 9| 1| 1| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | 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 | | | | | | __________________________________________________________________________|____________| Blood | | 1 | __________________________________________________________________________|____________| Bone Marrow | + + + + + A + + + + | 49 | Hemorrhage | 3 | 2 3.5| Myelofibrosis | 4 | 1 4.0| __________________________________________________________________________|____________| Lymph Node | + + + + + + + + + + | 50 | Mediastinal, Congestion | 3 | 3 2.7| Mediastinal, Hemorrhage | 3 | 1 3.0| Mediastinal, Infiltration Cellular, | | | Plasma Cell | | 1 2.0| Pancreatic, Congestion | 3 | 1 3.0| __________________________________________________________________________|____________| Lymph Node, Mandibular | + + + + + + + + + + | 48 | Congestion | 3 | 1 3.0| Cyst | | 4 | Hyperplasia, Lymphoid | 2 2 3 2 2 2 2 | 39 2.2| Inflammation, Acute | | 1 3.0| __________________________________________________________________________|____________| Lymph Node, Mesenteric | + + + + + + + + + + | 49 | Congestion | | 1 2.0| Edema | | 1 3.0| Hemorrhage | 4 | 1 4.0| Hyperplasia, Lymphoid | | 1 4.0| __________________________________________________________________________|____________| Spleen | + + + + + + + + + + | 50 | Fibrosis | 2 2 | 4 2.5| Hematopoietic Cell Proliferation | 1 2 3 1 2 3 2 1 | 37 2.2| Hyperplasia, Lymphoid | | 3 2.0| Pigmentation | 2 2 2 2 2 2 | 23 2.2| __________________________________________________________________________|____________| Thymus | + + + + + + + + + + | 49 | Congestion | | 1 2.0| Cyst | X | 2 | Hyperplasia, Lymphoid | | 1 2.0| _____________________________________________________________________________________________________________________| | INTEGUMENTARY SYSTEM | | | | | | __________________________________________________________________________|____________| Mammary Gland | + + + + + + + + + + | 48 | Acinus, Ectasia | 2 4 3 2 | 16 2.5| Duct, Ectasia | 3 | 2 2.5| __________________________________________________________________________|____________| Skin | + + + + + + + + + + | 50 | Alopecia | | 1 | Cyst Epithelial Inclusion | | 1 | Hyperkeratosis | 4 | 2 4.0| Inflammation, Chronic Active | | 1 2.0| __________________________________________________________________________________________________________________________________ * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 71 NTP Experiment-Test: 05007-06 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 07:49:23 __________________________________________________________________________________________________________________________________ | 6| 7| 7| 7| 7| 2| 6| 6| 7| 7| | | DAY ON TEST | 3| 0| 3| 3| 3| 5| 8| 7| 3| 3| | | | 7| 0| 1| 1| 1| 8| 2| 9| 1| 1| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | 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| | | __________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM - cont | | | | | | Ulcer | 4 | 2 4.0| _____________________________________________________________________________________________________________________| | MUSCULOSKELETAL SYSTEM | | | | | | __________________________________________________________________________|____________| Bone | + + + + + + + + + + | 50 | _____________________________________________________________________________________________________________________| | NERVOUS SYSTEM | | | | | | __________________________________________________________________________|____________| Brain | + + + + + + + + + + | 50 | Compression | X | 6 2.0| Hemorrhage | | 1 2.0| Hydrocephalus | | 1 2.0| _____________________________________________________________________________________________________________________| | RESPIRATORY SYSTEM | | | | | | __________________________________________________________________________|____________| Lung | + + + + + + + + + + | 50 | Congestion | 2 4 2 | 5 2.8| Hemorrhage | 1 2 2 2 1 | 12 1.8| Alveolus, Infiltration Cellular, | | | Histiocyte | 2 2 | 13 1.8| Alveolus, Mineralization | | 2 1.5| Arteriole, Mineralization | 2 2 2 2 2 2 | 34 1.9| Bronchiole, Inflammation, Acute | | 1 1.0| Interstitium, Inflammation, Chronic | | 1 2.0| Interstitium, Inflammation, Chronic | | | Active | | 1 3.0| Peribronchiolar, Inflammation, | | | Chronic Active | | 1 3.0| __________________________________________________________________________|____________| Nose | + + + + + + + + + + | 50 | Lumen, Hemorrhage | 1 | 7 1.3| Mucosa, Inflammation, Acute | 2 2 2 | 9 2.7| Mucosa, Inflammation, Chronic | | 2 2.0| Nasolacrimal Duct, Hemorrhage | 2 | 2 2.0| Nasolacrimal Duct, Inflammation, | | | Acute | | 8 2.4| Olfactory Epithelium, Degeneration | 2 2 2 2 2 2 2 2 2 | 38 1.9| Respiratory Epithelium, Degeneration | | 7 1.3| Respiratory Epithelium, Metaplasia, | | | Squamous | | 1 4.0| __________________________________________________________________________|____________| Trachea | + + + + + + + + + + | 50 | Inflammation, Acute | | 1 3.0| _____________________________________________________________________________________________________________________| | SPECIAL SENSES 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 72 NTP Experiment-Test: 05007-06 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 07:49:23 __________________________________________________________________________________________________________________________________ | 6| 7| 7| 7| 7| 2| 6| 6| 7| 7| | | DAY ON TEST | 3| 0| 3| 3| 3| 5| 8| 7| 3| 3| | | | 7| 0| 1| 1| 1| 8| 2| 9| 1| 1| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | 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| | | __________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM - cont | | | | | | | | | __________________________________________________________________________|____________| Ear | | 2 | __________________________________________________________________________|____________| Eye | + + + + | 14 | Cataract | 4 4 3 4 | 12 3.7| Hemorrhage | 4 4 4 | 5 3.8| Inflammation, Chronic | | 1 4.0| Anterior Chamber, Hemorrhage | | 1 3.0| Cornea, Inflammation, Acute | | 1 4.0| Posterior Chamber, Synechia | 4 | 2 3.5| Retina, Degeneration | 4 4 4 4 | 12 4.0| Sclera, Mineralization | 2 | 2 2.0| _____________________________________________________________________________________________________________________| | URINARY SYSTEM | | | | | | __________________________________________________________________________|____________| Kidney | + + + + + + + + + + | 50 | Congestion | 2 | 1 2.0| Cyst | | 1 | Infarct | | 1 4.0| Nephropathy, Chronic | 3 4 3 4 4 4 3 4 3 | 49 3.0| Cortex, Cyst | | 1 | Renal Tubule, Pigmentation | 3 2 2 2 1 2 2 1 2 | 42 1.7| __________________________________________________________________________|____________| Urethra | | 3 | Calculus Micro Observation Only | | 3 | __________________________________________________________________________|____________| Urinary Bladder | + + + + + A + + + + | 49 | Calculus Micro Observation Only | | 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 73 NTP Experiment-Test: 05007-06 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 07:49:23 _____________________________________________________________________________________________________________________ | 0| 4| 6| 7| 7| 6| 6| 7| 7| 7| 4| 4| 4| 4| 4| 6| 7| 7| 7| 7| 5| 6| 7| 7| 7| DAY ON TEST | 9| 7| 4| 0| 3| 1| 9| 3| 3| 3| 6| 6| 6| 6| 6| 4| 0| 3| 3| 3| 0| 0| 0| 3| 3| | 8| 7| 4| 0| 4| 3| 5| 4| 4| 4| 2| 2| 2| 2| 2| 0| 8| 4| 4| 4| 3| 6| 1| 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| FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 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 | + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Large | + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Large, Cecum | + + + + + + + + + + + + + + + A + + + +| Parasite Metazoan | X | __________________________________________________________________________| Intestine Large, Colon | + + + + + + + + + + + + + + + + + + + +| Diverticulum | 3 | Metaplasia, Osseous | 3 | Parasite Metazoan | X X | __________________________________________________________________________| Intestine Large, Rectum | + + + + + + + + + + + + + + M + + + + +| Parasite Metazoan | X X | __________________________________________________________________________| Intestine Small | + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Small, Duodenum | + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Small, Ileum | + + + + + + + + + + + + + + + I + + M +| Inflammation, Chronic | | __________________________________________________________________________| Intestine Small, Jejunum | + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Liver | + + + + + + + + + + + + + + + + + + + +| Basophilic Focus | X X X X X X X| Clear Cell Focus | | Developmental Malformation | X X X X | Hematopoietic Cell Proliferation | | Necrosis | 2 2 2 2 | Vacuolization Cytoplasmic | | Bile Duct, Hyperplasia | 2 2 2 2 2 2 2 2 2 3 2 2 2 1 3 2 2 2| Portal, Inflammation, Chronic | 2 2 2 2 2 2 2 2 2 2 2 2 2 2 3 2 2 2| __________________________________________________________________________| Mesentery | + + + | Arteriole, Inflammation, Chronic | | Fat, Necrosis | 4 4 4 | __________________________________________________________________________| Pancreas | + + + + + + + + + + + + + + + + + + + +| Atrophy | | Acinus, Atrophy | 3 2 2 2 1 3 3 2 2 3 | Acinus, Hyperplasia | 3 2| Artery, Inflammation, Chronic | | __________________________________________________________________________| Salivary Glands | + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Stomach | + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Stomach, Forestomach | + + + + + + + + + + + + + + + + + + + +| Inflammation, Chronic Active | | Mineralization | 2 3 | Ulcer | | Epithelium, Hyperplasia | | __________________________________________________________________________| Stomach, Glandular | + + + + + + + + + + + + + + + + + + + +| Dilatation | | Mineralization | 3 | Mucosa, Dilatation | 2 2 2 2 2 2 2 2 2| Mucosa, Erosion | 3 | _____________________________________________________________________________________________________________________| Page 74 NTP Experiment-Test: 05007-06 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 07:49:23 _____________________________________________________________________________________________________________________ | 0| 4| 6| 7| 7| 6| 6| 7| 7| 7| 4| 4| 4| 4| 4| 6| 7| 7| 7| 7| 5| 6| 7| 7| 7| DAY ON TEST | 9| 7| 4| 0| 3| 1| 9| 3| 3| 3| 6| 6| 6| 6| 6| 4| 0| 3| 3| 3| 0| 0| 0| 3| 3| | 8| 7| 4| 0| 4| 3| 5| 4| 4| 4| 2| 2| 2| 2| 2| 0| 8| 4| 4| 4| 3| 6| 1| 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| FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 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 - cont | | | | _____________________________________________________________________________________________________________________| CARDIOVASCULAR SYSTEM | | | | __________________________________________________________________________| Heart | + + + + + + + + + + + + + + + + + + + +| Cardiomyopathy, Chronic | 2 2 1 2 3 3 3 2 2 2 3 3 2 3 2 2 2| Mineralization | | Atrium Left, Thrombosis | | Atrium Right, Thrombosis | | _____________________________________________________________________________________________________________________| ENDOCRINE SYSTEM | | | | __________________________________________________________________________| Adrenal Gland | + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Adrenal Gland, Cortex | + + + + + + + + + + + + + + + + + + + +| Degeneration, Fatty | 2 2 2 2 2 2 1 2 2 | Hyperplasia | 2 2 2 2 2| Pigmentation | | __________________________________________________________________________| Adrenal Gland, Medulla | + + + + + + + + + + + + + + + + + + + +| Hyperplasia | 2 3 1 2 2 1 2 2| __________________________________________________________________________| Islets, Pancreatic | + + + + + + + + + + + + + + + + + + + +| Hyperplasia | 2 | __________________________________________________________________________| Parathyroid Gland | + + + + + + + + + + + + + + + + + + + +| Hypertrophy | 2 | __________________________________________________________________________| Pituitary Gland | + + + + + + + + + + + + + + + + + + + +| Pars Distalis, Cyst | X | Pars Distalis, Hyperplasia | 2 2 2 1 2 2| Pars Intermedia, Cyst | | __________________________________________________________________________| Thyroid Gland | + + + + + + + + + + + + + + + + + + + +| Ultimobranchial Cyst | X | C-Cell, Hyperplasia | 2 2 2 2 | Follicle, Ectasia | 2 2 | _____________________________________________________________________________________________________________________| GENERAL BODY SYSTEM | | | | None | | _____________________________________________________________________________________________________________________| GENITAL SYSTEM | | | | __________________________________________________________________________| Epididymis | + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Preputial Gland | + + + + + + + + + + + + + + + + + + + +| Abscess | | Inflammation, Chronic | 2 2 2 2 3 2 2| Inflammation, Chronic Active | 2 2 2 4 4 2 3 | Duct, Ectasia | 4 | __________________________________________________________________________| Prostate | + + + + + + + + + + + + + + + + + + + +| Inflammation, Acute | 1 4 | Inflammation, Chronic | | Inflammation, Chronic Active | 2 4 3 3 2 2 3 2 2 2 2 2 3 2 3| __________________________________________________________________________| Seminal Vesicle | + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| Page 75 NTP Experiment-Test: 05007-06 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 07:49:23 _____________________________________________________________________________________________________________________ | 0| 4| 6| 7| 7| 6| 6| 7| 7| 7| 4| 4| 4| 4| 4| 6| 7| 7| 7| 7| 5| 6| 7| 7| 7| DAY ON TEST | 9| 7| 4| 0| 3| 1| 9| 3| 3| 3| 6| 6| 6| 6| 6| 4| 0| 3| 3| 3| 0| 0| 0| 3| 3| | 8| 7| 4| 0| 4| 3| 5| 4| 4| 4| 2| 2| 2| 2| 2| 0| 8| 4| 4| 4| 3| 6| 1| 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| FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 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| _____________________________________________________________________________________________________________________| GENITAL SYSTEM - cont | | | | __________________________________________________________________________| Testes | + + + + + + + + + + + + + + + + + + + +| Atrophy | 3 | Granuloma Sperm | | Necrosis | 4 | Artery, Inflammation, Chronic | 2 2 | Interstitial Cell, Hyperplasia | 2 1 1 3 | _____________________________________________________________________________________________________________________| HEMATOPOIETIC SYSTEM | | | | __________________________________________________________________________| Blood | + | Atypia Cellular | X | __________________________________________________________________________| Bone Marrow | + + + + + + + + + + + + + + + + + + + +| Hemorrhage | | __________________________________________________________________________| Lymph Node | + + + + + + + + + + + + + + + + + + + +| Mediastinal, Congestion | 2 2 | Mediastinal, Hyperplasia, Lymphoid | 3 | Mediastinal, Infiltration Cellular, | | Plasma Cell | 2 | Mediastinal, Infiltration Cellular, | | Histiocyte | | Mediastinal, Pigmentation | | __________________________________________________________________________| Lymph Node, Mandibular | + + + + + + + + + + + + + + + + + + + +| Congestion | 3 | Cyst | X X X X | Hyperplasia, Lymphoid | 2 2 2 2 2 2 2 2 3 2 3| __________________________________________________________________________| Lymph Node, Mesenteric | + + + + + + + + + + + + + + + + + + + +| Congestion | 2 | Cyst | X | Infiltration Cellular, Plasma Cell | | Inflammation, Acute | 4 | __________________________________________________________________________| Spleen | + + + + + + + + + + + + + + + + + + + +| Fibrosis | 2 3 3 2| Hematopoietic Cell Proliferation | 1 4 2 1 1 1 2 1 1 1 2 1 2 1| Hyperplasia, Lymphoid | | Hyperplasia, Reticulum Cell | | Pigmentation | 2 2 2 2 2 2 2 2 2 2 2 2 | __________________________________________________________________________| Thymus | + + + M + + + + + M M M + M + + + + + M| Congestion | | Cyst | | _____________________________________________________________________________________________________________________| INTEGUMENTARY SYSTEM | | | | __________________________________________________________________________| Mammary Gland | M + + + + + + + + + + + + M + + + + M +| Acinus, Ectasia | 2 3 2 3 2 2 | Duct, Ectasia | 2 | __________________________________________________________________________| Skin | + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| Page 76 NTP Experiment-Test: 05007-06 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 07:49:23 _____________________________________________________________________________________________________________________ | 0| 4| 6| 7| 7| 6| 6| 7| 7| 7| 4| 4| 4| 4| 4| 6| 7| 7| 7| 7| 5| 6| 7| 7| 7| DAY ON TEST | 9| 7| 4| 0| 3| 1| 9| 3| 3| 3| 6| 6| 6| 6| 6| 4| 0| 3| 3| 3| 0| 0| 0| 3| 3| | 8| 7| 4| 0| 4| 3| 5| 4| 4| 4| 2| 2| 2| 2| 2| 0| 8| 4| 4| 4| 3| 6| 1| 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| FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 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| _____________________________________________________________________________________________________________________| INTEGUMENTARY SYSTEM - cont | | | | Abscess | | Alopecia | | Cyst Epithelial Inclusion | X | Inflammation, Chronic | 3 | Inflammation, Chronic Active | 2 | Ulcer | 4 | _____________________________________________________________________________________________________________________| MUSCULOSKELETAL SYSTEM | | | | __________________________________________________________________________| Bone | + + + + + + + + + + + + + + + + + + + +| Hyperostosis | | __________________________________________________________________________| Skeletal Muscle | + | _____________________________________________________________________________________________________________________| NERVOUS SYSTEM | | | | __________________________________________________________________________| Brain | + + + + + + + + + + + + + + + + + + + +| Compression | 2 2 | Hemorrhage | 4 4 | Necrosis | | __________________________________________________________________________| Spinal Cord | + | _____________________________________________________________________________________________________________________| RESPIRATORY SYSTEM | | | | __________________________________________________________________________| Lung | + + + + + + + + + + + + + + + + + + + +| Congestion | 2 | Hemorrhage | 2 | Alveolus, Infiltration Cellular, | | Histiocyte | 2 2 2 2| Arteriole, Mineralization | 2 2 2 2 1 2 2 2 2 2 2 2 2 2 | __________________________________________________________________________| Nose | + + + + + + + + + + + + + + + + + + + +| Lumen, Hemorrhage | 1 1 2 2 2 2 | Mucosa, Inflammation, Acute | 1 3 2 3 | Nasolacrimal Duct, Inflammation, | | Acute | 2 2 | Olfactory Epithelium, Degeneration | 1 2 2 2 2 2 2 1 2 2 1 2 2 2 1 1| Respiratory Epithelium, Degeneration | 1 2 | __________________________________________________________________________| Trachea | + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| SPECIAL SENSES SYSTEM | | | | __________________________________________________________________________| Ear | | __________________________________________________________________________| Eye | + + + | Cataract | 4 4 4 | Hemorrhage | | Retina, Degeneration | 4 4 4 | Sclera, Mineralization | | _____________________________________________________________________________________________________________________| URINARY SYSTEM | | | | _____________________________________________________________________________________________________________________| Page 77 NTP Experiment-Test: 05007-06 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 07:49:23 _____________________________________________________________________________________________________________________ | 0| 4| 6| 7| 7| 6| 6| 7| 7| 7| 4| 4| 4| 4| 4| 6| 7| 7| 7| 7| 5| 6| 7| 7| 7| DAY ON TEST | 9| 7| 4| 0| 3| 1| 9| 3| 3| 3| 6| 6| 6| 6| 6| 4| 0| 3| 3| 3| 0| 0| 0| 3| 3| | 8| 7| 4| 0| 4| 3| 5| 4| 4| 4| 2| 2| 2| 2| 2| 0| 8| 4| 4| 4| 3| 6| 1| 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| FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 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| _____________________________________________________________________________________________________________________| URINARY SYSTEM - cont | | | | __________________________________________________________________________| Kidney | + + + + + + + + + + + + + + + + + + + +| Nephropathy, Chronic | 2 4 4 3 2 2 4 2 4 2 3 3 4 2 2 3 4 2 4| Pelvis, Dilatation | | Renal Tubule, Pigmentation | 1 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2| __________________________________________________________________________| Urethra | + + | Calculus Micro Observation Only | X X | __________________________________________________________________________| Urinary Bladder | + + + + + + + + + + + + + + + + + + + +| Inflammation, Chronic | 4 | _____________________________________________________________________________________________________________________| Page 78 NTP Experiment-Test: 05007-06 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 07:49:23 _____________________________________________________________________________________________________________________ | 5| 6| 7| 6| 7| 6| 6| 7| 7| 7| 6| 6| 6| 7| 7| 5| 6| 6| 6| 7| 6| 6| 7| 7| 7| DAY ON TEST | 8| 3| 2| 7| 3| 3| 7| 2| 3| 3| 1| 1| 8| 3| 3| 3| 1| 5| 6| 3| 4| 9| 1| 3| 3| | 9| 2| 4| 5| 4| 7| 7| 2| 4| 4| 6| 8| 3| 4| 4| 5| 7| 8| 7| 4| 6| 2| 0| 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| FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 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 | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Large | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Large, Cecum | + + + + + + + + + + + + + + + + + + + + + + + + +| Parasite Metazoan | X X X| __________________________________________________________________________| Intestine Large, Colon | + + + + + + + + + + + + + + + + + + + + + + + + +| Diverticulum | | Metaplasia, Osseous | | Parasite Metazoan | X | __________________________________________________________________________| Intestine Large, Rectum | + + + + + + + + + + + + + + + + + + + + + + + + +| Parasite Metazoan | X | __________________________________________________________________________| Intestine Small | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Small, Duodenum | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Small, Ileum | + + + + + + M + + + + + + + + + + + + + + + + + +| Inflammation, Chronic | | __________________________________________________________________________| Intestine Small, Jejunum | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Liver | + + + + + + + + + + + + + + + + + + + + + + + + +| Basophilic Focus | X X X X X X X X X X X| Clear Cell Focus | X | Developmental Malformation | X X X X X | Hematopoietic Cell Proliferation | | Necrosis | 3 2 2 | Vacuolization Cytoplasmic | 1 | Bile Duct, Hyperplasia | 1 2 2 2 2 2 2 2 2 2 1 3 2 2 2 3 2 2 2 2 2 2 2| Portal, Inflammation, Chronic | 2 2 2 2 2 2 2 2 2 1 3 2 2 2 2 2 3 2 2 2 2 2 2| __________________________________________________________________________| Mesentery | + + + + + | Arteriole, Inflammation, Chronic | 3 | Fat, Necrosis | 4 4 | __________________________________________________________________________| Pancreas | + + + + + + + + + + + + + + + + + + + + + + + + +| Atrophy | 2 | Acinus, Atrophy | 2 3 2 2 2 2 2 3 3 1 2 | Acinus, Hyperplasia | 3 2 | Artery, Inflammation, Chronic | 2 3 | __________________________________________________________________________| Salivary Glands | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Stomach | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Stomach, Forestomach | + + + + + + + + + + + + + + + + + + + + + + + + +| Inflammation, Chronic Active | | Mineralization | 2 3 | Ulcer | 4 | Epithelium, Hyperplasia | | __________________________________________________________________________| Stomach, Glandular | + + + + + + + + + + + + + + + + + + + + + + + + +| Dilatation | 2 | Mineralization | 3 | Mucosa, Dilatation | 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2| Mucosa, Erosion | 1 | _____________________________________________________________________________________________________________________| Page 79 NTP Experiment-Test: 05007-06 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 07:49:23 _____________________________________________________________________________________________________________________ | 5| 6| 7| 6| 7| 6| 6| 7| 7| 7| 6| 6| 6| 7| 7| 5| 6| 6| 6| 7| 6| 6| 7| 7| 7| DAY ON TEST | 8| 3| 2| 7| 3| 3| 7| 2| 3| 3| 1| 1| 8| 3| 3| 3| 1| 5| 6| 3| 4| 9| 1| 3| 3| | 9| 2| 4| 5| 4| 7| 7| 2| 4| 4| 6| 8| 3| 4| 4| 5| 7| 8| 7| 4| 6| 2| 0| 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| FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 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 - cont | | | | _____________________________________________________________________________________________________________________| CARDIOVASCULAR SYSTEM | | | | __________________________________________________________________________| Heart | + + + + + + + + + + + + + + + + + + + + + + + + +| Cardiomyopathy, Chronic | 2 2 2 3 2 1 3 3 4 3 2 1 3 3 2 3 3 2 3 3 2 3 3 3| Mineralization | 2 | Atrium Left, Thrombosis | 2 | Atrium Right, Thrombosis | | _____________________________________________________________________________________________________________________| ENDOCRINE SYSTEM | | | | __________________________________________________________________________| Adrenal Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Adrenal Gland, Cortex | + + + + + + + + + + + + + + + + + + + + + + + + +| Degeneration, Fatty | 2 2 1 1 2 2 2 2| Hyperplasia | 2 2 2 2 2 2 2| Pigmentation | 2 | __________________________________________________________________________| Adrenal Gland, Medulla | + + + + + + + + + + + + + + + + + + + + + + + + +| Hyperplasia | 1 2 2 2 2 2 2 1 2 2 3| __________________________________________________________________________| Islets, Pancreatic | + + + + + M + + + + + + + + + + + + + + + + M + +| Hyperplasia | 2| __________________________________________________________________________| Parathyroid Gland | + + + + + M + + + + + M + + + + + + + + + + + M +| Hypertrophy | | __________________________________________________________________________| Pituitary Gland | + + + + + + + M + + + + + + + + + + + + + + + + +| Pars Distalis, Cyst | X X | Pars Distalis, Hyperplasia | 2 2 1 2 2 2 2 | Pars Intermedia, Cyst | X | __________________________________________________________________________| Thyroid Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| Ultimobranchial Cyst | | C-Cell, Hyperplasia | 2 2 2 1 1 1 2 2 | Follicle, Ectasia | | _____________________________________________________________________________________________________________________| GENERAL BODY SYSTEM | | | | None | | _____________________________________________________________________________________________________________________| GENITAL SYSTEM | | | | __________________________________________________________________________| Epididymis | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Preputial Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| Abscess | 4 | Inflammation, Chronic | 2 2 2 3 3 2 3 2 2| Inflammation, Chronic Active | 2 3 2 2 2 3 3 3 3 3 3 2 3 | Duct, Ectasia | 3 3 3| __________________________________________________________________________| Prostate | + + + + + + + + + + + + + + + + + + + + + + + + +| Inflammation, Acute | | Inflammation, Chronic | 2 2 | Inflammation, Chronic Active | 3 3 3 4 3 3 2 3 3 3 2 3 3 2 3 3 3 4 2 2 4 4| __________________________________________________________________________| Seminal Vesicle | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| Page 80 NTP Experiment-Test: 05007-06 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 07:49:23 _____________________________________________________________________________________________________________________ | 5| 6| 7| 6| 7| 6| 6| 7| 7| 7| 6| 6| 6| 7| 7| 5| 6| 6| 6| 7| 6| 6| 7| 7| 7| DAY ON TEST | 8| 3| 2| 7| 3| 3| 7| 2| 3| 3| 1| 1| 8| 3| 3| 3| 1| 5| 6| 3| 4| 9| 1| 3| 3| | 9| 2| 4| 5| 4| 7| 7| 2| 4| 4| 6| 8| 3| 4| 4| 5| 7| 8| 7| 4| 6| 2| 0| 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| FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 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| _____________________________________________________________________________________________________________________| GENITAL SYSTEM - cont | | | | __________________________________________________________________________| Testes | + + + + + + + + + + + + + + + + + + + + + + + + +| Atrophy | 2 2 3 3 3 | Granuloma Sperm | 2 | Necrosis | | Artery, Inflammation, Chronic | 2 | Interstitial Cell, Hyperplasia | 2 1 1 2 1 1 1 2 1| _____________________________________________________________________________________________________________________| HEMATOPOIETIC SYSTEM | | | | __________________________________________________________________________| Blood | + + + | Atypia Cellular | | __________________________________________________________________________| Bone Marrow | + + + + + + + + + + + + + + + + + + + + + + + + +| Hemorrhage | 3 | __________________________________________________________________________| Lymph Node | + + + + + + + + + + + + + + + + + + + + + + + + +| Mediastinal, Congestion | 2 3 | Mediastinal, Hyperplasia, Lymphoid | | Mediastinal, Infiltration Cellular, | | Plasma Cell | | Mediastinal, Infiltration Cellular, | | Histiocyte | 2 | Mediastinal, Pigmentation | 2 2 | __________________________________________________________________________| Lymph Node, Mandibular | + + + + + + + + + + + + + + + + + + + + + + + + +| Congestion | | Cyst | X X | Hyperplasia, Lymphoid | 2 2 2 2 2 3 2 2 2 2 2 2 2 2 2 3 2 2| __________________________________________________________________________| Lymph Node, Mesenteric | + + + + + + + + + + + + + + + + + + + + + + + + +| Congestion | 4 | Cyst | | Infiltration Cellular, Plasma Cell | 2 | Inflammation, Acute | | __________________________________________________________________________| Spleen | + + + + + + + + + + + + + + + + + + + + + + + + +| Fibrosis | 4 | Hematopoietic Cell Proliferation | 2 2 3 2 3 2 2 4 2 1 1 3 2 1| Hyperplasia, Lymphoid | 3 2 | Hyperplasia, Reticulum Cell | | Pigmentation | 2 2 2 2 3 2 2 3 2 3 2| __________________________________________________________________________| Thymus | + + M M + + + + + + + + + + + + + + + + + + + + +| Congestion | 2 | Cyst | X | _____________________________________________________________________________________________________________________| INTEGUMENTARY SYSTEM | | | | __________________________________________________________________________| Mammary Gland | + + M + + M + M M + + M + + + + + + + + + + + + M| Acinus, Ectasia | 3 2 2 3 2 2 2 3 | Duct, Ectasia | 3 2 | __________________________________________________________________________| Skin | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| Page 81 NTP Experiment-Test: 05007-06 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 07:49:23 _____________________________________________________________________________________________________________________ | 5| 6| 7| 6| 7| 6| 6| 7| 7| 7| 6| 6| 6| 7| 7| 5| 6| 6| 6| 7| 6| 6| 7| 7| 7| DAY ON TEST | 8| 3| 2| 7| 3| 3| 7| 2| 3| 3| 1| 1| 8| 3| 3| 3| 1| 5| 6| 3| 4| 9| 1| 3| 3| | 9| 2| 4| 5| 4| 7| 7| 2| 4| 4| 6| 8| 3| 4| 4| 5| 7| 8| 7| 4| 6| 2| 0| 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| FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 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| _____________________________________________________________________________________________________________________| INTEGUMENTARY SYSTEM - cont | | | | Abscess | 4 | Alopecia | 2 | Cyst Epithelial Inclusion | | Inflammation, Chronic | 2 | Inflammation, Chronic Active | | Ulcer | | _____________________________________________________________________________________________________________________| MUSCULOSKELETAL SYSTEM | | | | __________________________________________________________________________| Bone | + + + + + + + + + + + + + + + + + + + + + + + + +| Hyperostosis | 3 | __________________________________________________________________________| Skeletal Muscle | + | _____________________________________________________________________________________________________________________| NERVOUS SYSTEM | | | | __________________________________________________________________________| Brain | + + + + + + + + + + + + + + + + + + + + + + + + +| Compression | 2 3 3 | Hemorrhage | | Necrosis | 3 | __________________________________________________________________________| Spinal Cord | + | _____________________________________________________________________________________________________________________| RESPIRATORY SYSTEM | | | | __________________________________________________________________________| Lung | + + + + + + + + + + + + + + + + + + + + + + + + +| Congestion | 2 2 | Hemorrhage | 3 2 | Alveolus, Infiltration Cellular, | | Histiocyte | | Arteriole, Mineralization | 2 2 2 2 2 2 2 2 2 1 2 2 2 2 2 2 2| __________________________________________________________________________| Nose | + + + + + + + + + + + + + + + + + + + + + + + + +| Lumen, Hemorrhage | 1 3 2 1 1 | Mucosa, Inflammation, Acute | 2 4 3 | Nasolacrimal Duct, Inflammation, | | Acute | 2 2 2 1 2 2 2 2 2| Olfactory Epithelium, Degeneration | 2 2 2 2 2 2 2 2 2 2 2 2 2 2| Respiratory Epithelium, Degeneration | 1 2 2| __________________________________________________________________________| Trachea | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| SPECIAL SENSES SYSTEM | | | | __________________________________________________________________________| Ear | + + | __________________________________________________________________________| Eye | + + + + + + + | Cataract | 4 4 4 4 2 4 4 | Hemorrhage | 2 3 | Retina, Degeneration | 4 4 4 4 4 4 4 | Sclera, Mineralization | 4 | _____________________________________________________________________________________________________________________| URINARY SYSTEM | | | | _____________________________________________________________________________________________________________________| Page 82 NTP Experiment-Test: 05007-06 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 07:49:23 _____________________________________________________________________________________________________________________ | 5| 6| 7| 6| 7| 6| 6| 7| 7| 7| 6| 6| 6| 7| 7| 5| 6| 6| 6| 7| 6| 6| 7| 7| 7| DAY ON TEST | 8| 3| 2| 7| 3| 3| 7| 2| 3| 3| 1| 1| 8| 3| 3| 3| 1| 5| 6| 3| 4| 9| 1| 3| 3| | 9| 2| 4| 5| 4| 7| 7| 2| 4| 4| 6| 8| 3| 4| 4| 5| 7| 8| 7| 4| 6| 2| 0| 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| FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 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| _____________________________________________________________________________________________________________________| URINARY SYSTEM - cont | | | | __________________________________________________________________________| Kidney | + + + + + + + + + + + + + + + + + + + + + + + + +| Nephropathy, Chronic | 2 4 2 2 4 2 4 2 4 4 3 4 2 4 4 2 2 3 3 4 4 2 4 3 4| Pelvis, Dilatation | 4 | Renal Tubule, Pigmentation | 2 2 2 2 2 3 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2| __________________________________________________________________________| Urethra | | Calculus Micro Observation Only | | __________________________________________________________________________| Urinary Bladder | + + + + + + + + + + + + + + + + + + + + + + + + +| Inflammation, Chronic | | _____________________________________________________________________________________________________________________| Page 83 NTP Experiment-Test: 05007-06 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 07:49:23 __________________________________________________________________________________________________________________________________ | 4| 4| 4| 4| 4| 6| 6| 6| 7| 7| | | DAY ON TEST | 6| 6| 6| 6| 6| 3| 3| 8| 0| 3| | | | 2| 2| 2| 2| 2| 8| 5| 7| 1| 4| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | 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 | + + + + + | 50 | __________________________________________________________________________|____________| Intestine Large | + + + + + | 50 | __________________________________________________________________________|____________| Intestine Large, Cecum | + + + + + | 49 | Parasite Metazoan | X | 5 | __________________________________________________________________________|____________| Intestine Large, Colon | + + + + + | 50 | Diverticulum | | 1 3.0| Metaplasia, Osseous | | 1 3.0| Parasite Metazoan | X | 4 | __________________________________________________________________________|____________| Intestine Large, Rectum | + + + + + | 49 | Parasite Metazoan | X X | 5 | __________________________________________________________________________|____________| Intestine Small | + + + + + | 50 | __________________________________________________________________________|____________| Intestine Small, Duodenum | + + + + + | 50 | __________________________________________________________________________|____________| Intestine Small, Ileum | + + + + + | 47 | Inflammation, Chronic | 2 | 1 2.0| __________________________________________________________________________|____________| Intestine Small, Jejunum | + + + + + | 50 | __________________________________________________________________________|____________| Liver | + + + + + | 50 | Basophilic Focus | X X X | 21 | Clear Cell Focus | | 1 | Developmental Malformation | | 9 | Hematopoietic Cell Proliferation | 2 | 1 2.0| Necrosis | 1 | 8 2.0| Vacuolization Cytoplasmic | 2 | 2 1.5| Bile Duct, Hyperplasia | 2 2 2 | 44 2.0| Portal, Inflammation, Chronic | 1 2 2 2 | 45 2.0| __________________________________________________________________________|____________| Mesentery | + + | 10 | Arteriole, Inflammation, Chronic | | 1 3.0| Fat, Necrosis | 3 4 | 7 3.9| __________________________________________________________________________|____________| Pancreas | + + + + + | 50 | Atrophy | | 1 2.0| Acinus, Atrophy | 2 | 22 2.2| Acinus, Hyperplasia | | 4 2.5| Artery, Inflammation, Chronic | | 2 2.5| __________________________________________________________________________|____________| Salivary Glands | + + + + + | 50 | __________________________________________________________________________|____________| Stomach | + + + + + | 50 | __________________________________________________________________________|____________| Stomach, Forestomach | + + + + + | 50 | Inflammation, Chronic Active | 3 | 1 3.0| Mineralization | | 4 2.5| Ulcer | | 1 4.0| Epithelium, Hyperplasia | 2 | 1 2.0| __________________________________________________________________________________________________________________________________ * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 84 NTP Experiment-Test: 05007-06 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 07:49:23 __________________________________________________________________________________________________________________________________ | 4| 4| 4| 4| 4| 6| 6| 6| 7| 7| | | DAY ON TEST | 6| 6| 6| 6| 6| 3| 3| 8| 0| 3| | | | 2| 2| 2| 2| 2| 8| 5| 7| 1| 4| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | 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 | | | | | | __________________________________________________________________________|____________| Stomach, Glandular | + + + + + | 50 | Dilatation | | 1 2.0| Mineralization | | 2 3.0| Mucosa, Dilatation | 2 2 2 2 | 29 2.0| Mucosa, Erosion | | 2 2.0| _____________________________________________________________________________________________________________________| | CARDIOVASCULAR SYSTEM | | | | | | __________________________________________________________________________|____________| Heart | + + + + + | 50 | Cardiomyopathy, Chronic | 2 2 3 3 3 | 46 2.5| Mineralization | | 1 2.0| Atrium Left, Thrombosis | | 1 2.0| Atrium Right, Thrombosis | X | 1 | _____________________________________________________________________________________________________________________| | ENDOCRINE SYSTEM | | | | | | __________________________________________________________________________|____________| Adrenal Gland | + + + + + | 50 | __________________________________________________________________________|____________| Adrenal Gland, Cortex | + + + + + | 50 | Degeneration, Fatty | 2 2 3 2 | 21 1.9| Hyperplasia | 2 | 13 2.0| Pigmentation | | 1 2.0| __________________________________________________________________________|____________| Adrenal Gland, Medulla | + + + + + | 50 | Hyperplasia | 3 2 2 | 22 2.0| __________________________________________________________________________|____________| Islets, Pancreatic | + + + + + | 48 | Hyperplasia | | 2 2.0| __________________________________________________________________________|____________| Parathyroid Gland | + + + + + | 47 | Hypertrophy | | 1 2.0| __________________________________________________________________________|____________| Pituitary Gland | + + + + + | 49 | Pars Distalis, Cyst | X X | 5 | Pars Distalis, Hyperplasia | 2 | 14 1.9| Pars Intermedia, Cyst | X | 2 | __________________________________________________________________________|____________| Thyroid Gland | + + + + + | 50 | Ultimobranchial Cyst | | 1 | C-Cell, Hyperplasia | | 12 1.8| Follicle, Ectasia | | 2 2.0| _____________________________________________________________________________________________________________________| | GENERAL BODY SYSTEM | | | | | | None | | | _____________________________________________________________________________________________________________________| | GENITAL SYSTEM | | | | | | __________________________________________________________________________|____________| Epididymis | + + + + + | 50 | __________________________________________________________________________________________________________________________________ * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 85 NTP Experiment-Test: 05007-06 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 07:49:23 __________________________________________________________________________________________________________________________________ | 4| 4| 4| 4| 4| 6| 6| 6| 7| 7| | | DAY ON TEST | 6| 6| 6| 6| 6| 3| 3| 8| 0| 3| | | | 2| 2| 2| 2| 2| 8| 5| 7| 1| 4| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | 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 | | | | | | __________________________________________________________________________|____________| Preputial Gland | + + + + + | 50 | Abscess | | 1 4.0| Inflammation, Chronic | 1 2 | 18 2.2| Inflammation, Chronic Active | 4 | 21 2.7| Duct, Ectasia | | 4 3.3| __________________________________________________________________________|____________| Prostate | + + + + + | 50 | Inflammation, Acute | | 2 2.5| Inflammation, Chronic | | 2 2.0| Inflammation, Chronic Active | 4 4 2 3 | 41 2.8| __________________________________________________________________________|____________| Seminal Vesicle | + + + + + | 50 | __________________________________________________________________________|____________| Testes | + + + + + | 50 | Atrophy | 3 | 7 2.7| Granuloma Sperm | | 1 2.0| Necrosis | | 1 4.0| Artery, Inflammation, Chronic | | 3 2.0| Interstitial Cell, Hyperplasia | 1 1 | 15 1.4| _____________________________________________________________________________________________________________________| | HEMATOPOIETIC SYSTEM | | | | | | __________________________________________________________________________|____________| Blood | | 4 | Atypia Cellular | | 1 | __________________________________________________________________________|____________| Bone Marrow | + + + + + | 50 | Hemorrhage | | 1 3.0| __________________________________________________________________________|____________| Lymph Node | + + + + + | 50 | Mediastinal, Congestion | | 4 2.3| Mediastinal, Hyperplasia, Lymphoid | | 1 3.0| Mediastinal, Infiltration Cellular, | | | Plasma Cell | | 1 2.0| Mediastinal, Infiltration Cellular, | | | Histiocyte | | 1 2.0| Mediastinal, Pigmentation | | 2 2.0| __________________________________________________________________________|____________| Lymph Node, Mandibular | + + + + + | 50 | Congestion | | 1 3.0| Cyst | | 6 | Hyperplasia, Lymphoid | 2 2 | 31 2.1| __________________________________________________________________________|____________| Lymph Node, Mesenteric | + + + + + | 50 | Congestion | 2 | 3 2.7| Cyst | | 1 | Infiltration Cellular, Plasma Cell | | 1 2.0| Inflammation, Acute | | 1 4.0| __________________________________________________________________________________________________________________________________ * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 86 NTP Experiment-Test: 05007-06 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 07:49:23 __________________________________________________________________________________________________________________________________ | 4| 4| 4| 4| 4| 6| 6| 6| 7| 7| | | DAY ON TEST | 6| 6| 6| 6| 6| 3| 3| 8| 0| 3| | | | 2| 2| 2| 2| 2| 8| 5| 7| 1| 4| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | 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| | | __________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - cont | | | | | | __________________________________________________________________________|____________| Spleen | + + + + + | 50 | Fibrosis | | 5 2.8| Hematopoietic Cell Proliferation | 3 3 2 | 31 1.9| Hyperplasia, Lymphoid | | 2 2.5| Hyperplasia, Reticulum Cell | 2 | 1 2.0| Pigmentation | 3 2 2 | 26 2.2| __________________________________________________________________________|____________| Thymus | + + + M M | 40 | Congestion | | 1 2.0| Cyst | | 1 | _____________________________________________________________________________________________________________________| | INTEGUMENTARY SYSTEM | | | | | | __________________________________________________________________________|____________| Mammary Gland | M M + + + | 39 | Acinus, Ectasia | 2 | 15 2.3| Duct, Ectasia | | 3 2.3| __________________________________________________________________________|____________| Skin | + + + + + | 50 | Abscess | | 1 4.0| Alopecia | | 1 2.0| Cyst Epithelial Inclusion | | 1 | Inflammation, Chronic | | 2 2.5| Inflammation, Chronic Active | | 1 2.0| Ulcer | | 1 4.0| _____________________________________________________________________________________________________________________| | MUSCULOSKELETAL SYSTEM | | | | | | __________________________________________________________________________|____________| Bone | + + + + + | 50 | Hyperostosis | | 1 3.0| __________________________________________________________________________|____________| Skeletal Muscle | | 2 | _____________________________________________________________________________________________________________________| | NERVOUS SYSTEM | | | | | | __________________________________________________________________________|____________| Brain | + + + + + | 50 | Compression | | 5 2.4| Hemorrhage | | 2 4.0| Necrosis | | 1 3.0| __________________________________________________________________________|____________| Spinal Cord | | 2 | _____________________________________________________________________________________________________________________| | RESPIRATORY SYSTEM | | | | | | __________________________________________________________________________|____________| Lung | + + + + + | 50 | Congestion | 3 | 4 2.3| Hemorrhage | 2 | 4 2.3| Alveolus, Infiltration Cellular, | | | __________________________________________________________________________________________________________________________________ * : 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: 05007-06 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC POLYSORBATE 80 Date: 04/28/97 Route: DOSED FEED Time: 07:49:23 __________________________________________________________________________________________________________________________________ | 4| 4| 4| 4| 4| 6| 6| 6| 7| 7| | | DAY ON TEST | 6| 6| 6| 6| 6| 3| 3| 8| 0| 3| | | | 2| 2| 2| 2| 2| 8| 5| 7| 1| 4| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | 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| | | __________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM - cont | | | | | | Histiocyte | | 4 2.0| Arteriole, Mineralization | 2 1 2 2 | 35 1.9| __________________________________________________________________________|____________| Nose | + + + + + | 50 | Lumen, Hemorrhage | 1 | 12 1.6| Mucosa, Inflammation, Acute | | 7 2.6| Nasolacrimal Duct, Inflammation, | | | Acute | 2 | 12 1.9| Olfactory Epithelium, Degeneration | 2 2 2 2 | 34 1.9| Respiratory Epithelium, Degeneration | | 5 1.6| __________________________________________________________________________|____________| Trachea | + + + + + | 50 | _____________________________________________________________________________________________________________________| | SPECIAL SENSES SYSTEM | | | | | | __________________________________________________________________________|____________| Ear | | 2 | __________________________________________________________________________|____________| Eye | + | 11 | Cataract | 4 | 11 3.8| Hemorrhage | 3 | 3 2.7| Retina, Degeneration | 4 | 11 4.0| Sclera, Mineralization | | 1 4.0| _____________________________________________________________________________________________________________________| | URINARY SYSTEM | | | | | | __________________________________________________________________________|____________| Kidney | + + + + + | 50 | Nephropathy, Chronic | 2 4 2 3 4 | 49 3.0| Pelvis, Dilatation | | 1 4.0| Renal Tubule, Pigmentation | 1 2 2 2 2 | 48 2.0| __________________________________________________________________________|____________| Urethra | | 2 | Calculus Micro Observation Only | | 2 | __________________________________________________________________________|____________| Urinary Bladder | + + + + + | 50 | Inflammation, Chronic | | 1 4.0| __________________________________________________________________________________________________________________________________ * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 88 ------------------------------------------------------------ ---------- END OF REPORT ---------- ------------------------------------------------------------