TDMS Study 05108-02 Pathology Tables
NTP Experiment-Test: 05108-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:51:25 Facility: TSI Mason Research Chemical CAS #: 58-33-3 Lock Date: None Cage Range: All Reasons For Removal: All Removal Date Range: All Treatment Groups: Include All Page 1 NTP Experiment-Test: 05108-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:51:25 _____________________________________________________________________________________________________________________ | 7| 7| 7| 4| 5| 7| 7| 7| 7| 4| 7| 4| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 4| 4| 7| DAY ON TEST | 4| 4| 2| 6| 2| 4| 4| 4| 4| 6| 4| 6| 4| 4| 3| 4| 4| 4| 4| 4| 4| 4| 6| 6| 1| | 4| 4| 0| 2| 9| 4| 2| 3| 4| 4| 4| 2| 4| 4| 8| 4| 4| 4| 4| 3| 3| 3| 2| 2| 5| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| B6C3F1 MICE FEMALE | 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| ANIMAL ID | 5| 5| 5| 5| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 8| VEHICLE | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| FEMALE | 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| _____________________________________________________________________________________________________________________| ALIMENTARY SYSTEM | | | | __________________________________________________________________________| Esophagus | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Gallbladder | + + + + + + A + + + + + + + + + M + M + + M + + +| __________________________________________________________________________| Intestine Large, Colon | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Large, Rectum | + + + + + + M + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Large, Cecum | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Small, Duodenum | + + + + + + A + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Small, Jejunum | + + + + + + A + + + + + + + + + + + + M + + + + +| Erosion | | Inflammation, Chronic Active | | __________________________________________________________________________| Intestine Small, Ileum | + + + + + + A + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Liver | + + + + + + + + + + + + + + + + + + + + + + + + +| Basophilic Focus | | Eosinophilic Focus | X X X | Fatty Change, Focal | | Inflammation, Granulomatous | 3 | Mixed Cell Focus | | Necrosis | 1 | Vacuolization Cytoplasmic, Focal | | __________________________________________________________________________| Mesentery | + | Inflammation, Granulomatous | 3 | Fat, Necrosis | | __________________________________________________________________________| Pancreas | + + + + + + + + + + + + + + + + + + + + + + + + +| Artery, Inflammation, Chronic Active | 2 | __________________________________________________________________________| Salivary Glands | + + + + + + + + + + + + + + + + + + + + + + + + +| Artery, Inflammation, Chronic Active | 2 | __________________________________________________________________________| Stomach, Forestomach | + + + + + + + + + + + + + + + + + + + + + + + + +| Hyperplasia, Basal Cell | | __________________________________________________________________________| Stomach, Glandular | + + + + + + A + + + + + + + + + + + + + + + + + +| Inflammation, Chronic Active | 2 | Ulcer | | _____________________________________________________________________________________________________________________| CARDIOVASCULAR SYSTEM | | | | __________________________________________________________________________| Heart | + + + + + + + + + + + + + + + + + + + + + + + + +| Mineralization | | Artery, Mineralization | | _____________________________________________________________________________________________________________________| ENDOCRINE SYSTEM | | | | __________________________________________________________________________| Adrenal Cortex | + + + + + + + + + + + + + + + + + + + + + + + + +| Accessory Adrenal Cortical Nodule | | Hyperplasia | | Capsule, Hyperplasia | | __________________________________________________________________________| Adrenal Medulla | + + + + + + M + + + + + + + + M + + + + + + + + +| __________________________________________________________________________| Islets, Pancreatic | + + + + + + + + + + + + + + + + + + M + + + + + +| Hyperplasia | 2 | _____________________________________________________________________________________________________________________| Page 2 NTP Experiment-Test: 05108-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:51:25 _____________________________________________________________________________________________________________________ | 7| 7| 7| 4| 5| 7| 7| 7| 7| 4| 7| 4| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 4| 4| 7| DAY ON TEST | 4| 4| 2| 6| 2| 4| 4| 4| 4| 6| 4| 6| 4| 4| 3| 4| 4| 4| 4| 4| 4| 4| 6| 6| 1| | 4| 4| 0| 2| 9| 4| 2| 3| 4| 4| 4| 2| 4| 4| 8| 4| 4| 4| 4| 3| 3| 3| 2| 2| 5| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| B6C3F1 MICE FEMALE | 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| ANIMAL ID | 5| 5| 5| 5| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 8| VEHICLE | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| FEMALE | 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| _____________________________________________________________________________________________________________________| ENDOCRINE SYSTEM - cont | | | | __________________________________________________________________________| Parathyroid Gland | + M + + + + M + + M + M + + + + M M M M + + + + +| __________________________________________________________________________| Pituitary Gland | M + + + + + M + + + + + + + M + + + + + + + + + +| Pars Distalis, Angiectasis | 2 | Pars Distalis, Hyperplasia | 2 2 2 | __________________________________________________________________________| Thyroid Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| Follicle, Cyst | X X | Follicular Cell, Hyperplasia | 2 | _____________________________________________________________________________________________________________________| GENERAL BODY SYSTEM | | | | None | | _____________________________________________________________________________________________________________________| GENITAL SYSTEM | | | | __________________________________________________________________________| Clitoral Gland | | Dilatation | | __________________________________________________________________________| Ovary | + + + + + + + + M + + + + + + + + + + + + + + + +| Angiectasis | | Cyst | X X X| Hemorrhage | 3 | Hyperplasia | | Mineralization | 2 | Pigmentation | 2 | Thrombosis | 2 | __________________________________________________________________________| Uterus | + + + + + + + + + + + + + + + + + + + + + + + + +| Hemorrhage | | Endometrium, Hyperplasia | 2 | _____________________________________________________________________________________________________________________| HEMATOPOIETIC SYSTEM | | | | __________________________________________________________________________| Bone Marrow | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Lymph Node | + + + | __________________________________________________________________________| Lymph Node, Mandibular | + + + + + + + + + + + + + + + + + + + + + + + + +| Inflammation, Granulomatous | 3 | __________________________________________________________________________| Lymph Node, Mesenteric | + + + + + + + + + + + + + + + + + + + + + + + + +| Hemorrhage | 3 | Inflammation, Granulomatous | 3 | __________________________________________________________________________| Spleen | + + + + + + + + + + + + + + + + + + + + + + + + +| Amyloid Deposition | 3 | Hematopoietic Cell Proliferation | 2 3| __________________________________________________________________________| Thymus | + + + + + M M + + + + + + + + + + M + + + + + + M| _____________________________________________________________________________________________________________________| INTEGUMENTARY SYSTEM | | | | __________________________________________________________________________| Mammary Gland | + M + M + + M + + M M + + + + + + + M + + + + + +| __________________________________________________________________________| Skin | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| MUSCULOSKELETAL SYSTEM | | | | _____________________________________________________________________________________________________________________| Page 3 NTP Experiment-Test: 05108-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:51:25 _____________________________________________________________________________________________________________________ | 7| 7| 7| 4| 5| 7| 7| 7| 7| 4| 7| 4| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 4| 4| 7| DAY ON TEST | 4| 4| 2| 6| 2| 4| 4| 4| 4| 6| 4| 6| 4| 4| 3| 4| 4| 4| 4| 4| 4| 4| 6| 6| 1| | 4| 4| 0| 2| 9| 4| 2| 3| 4| 4| 4| 2| 4| 4| 8| 4| 4| 4| 4| 3| 3| 3| 2| 2| 5| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| B6C3F1 MICE FEMALE | 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| ANIMAL ID | 5| 5| 5| 5| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 8| VEHICLE | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| FEMALE | 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| _____________________________________________________________________________________________________________________| MUSCULOSKELETAL SYSTEM - cont | | | | __________________________________________________________________________| Bone | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| NERVOUS SYSTEM | | | | __________________________________________________________________________| Brain | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Spinal Cord | + | _____________________________________________________________________________________________________________________| RESPIRATORY SYSTEM | | | | __________________________________________________________________________| Lung | + + + + + + + + + + + + + + + + + + + + + + + + +| Hemorrhage | | Infiltration Cellular, Histiocyte | | Alveolar Epithelium, Hyperplasia | | Mediastinum, Inflammation, | | Granulomatous | 3 | __________________________________________________________________________| Nose | + + + + + + + + + + + + + + + + + + M + + + + + +| __________________________________________________________________________| Trachea | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| SPECIAL SENSES SYSTEM | | | | __________________________________________________________________________| Harderian Gland | + | _____________________________________________________________________________________________________________________| URINARY SYSTEM | | | | __________________________________________________________________________| Kidney | + + + + + + + + + + + + + + + + + + + + + + + + +| Inflammation, Granulomatous | 2 | Nephropathy | | Artery, Inflammation, Chronic Active | 2 | __________________________________________________________________________| Urinary Bladder | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| Page 4 NTP Experiment-Test: 05108-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:51:25 _____________________________________________________________________________________________________________________ | 4| 7| 7| 4| 7| 7| 7| 7| 5| 7| 6| 7| 7| 7| 7| 4| 7| 7| 7| 4| 7| 7| 6| 7| 4| DAY ON TEST | 6| 4| 4| 6| 4| 4| 4| 4| 8| 4| 2| 1| 4| 0| 4| 6| 2| 4| 4| 6| 4| 4| 0| 4| 6| | 4| 3| 3| 4| 4| 3| 3| 4| 2| 3| 2| 8| 3| 7| 3| 2| 8| 3| 3| 2| 3| 3| 1| 3| 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| B6C3F1 MICE FEMALE | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 3| 3| 3| 3| 3| 3| ANIMAL ID | 8| 8| 8| 8| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 0| 0| 0| 0| 0| 0| VEHICLE | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| FEMALE | 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| _____________________________________________________________________________________________________________________| ALIMENTARY SYSTEM | | | | __________________________________________________________________________| Esophagus | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Gallbladder | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Large, Colon | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Large, Rectum | + + + + + + + + + + + + + + + + + M + + M + + + +| __________________________________________________________________________| Intestine Large, Cecum | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Small, Duodenum | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Small, Jejunum | + + + + + + + + + + + + + + + + + + M + + + + + +| Erosion | 2 | Inflammation, Chronic Active | 3 | __________________________________________________________________________| Intestine Small, Ileum | + + + M + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Liver | + + + + + + + + + + + + + + + + + + + + + + + + +| Basophilic Focus | | Eosinophilic Focus | X X | Fatty Change, Focal | 1 | Inflammation, Granulomatous | | Mixed Cell Focus | X X X | Necrosis | 1 | Vacuolization Cytoplasmic, Focal | 2 | __________________________________________________________________________| Mesentery | + + + | Inflammation, Granulomatous | | Fat, Necrosis | 3 3 | __________________________________________________________________________| Pancreas | + + + + + + + + + + + + + + + + + + + + + + + + +| Artery, Inflammation, Chronic Active | | __________________________________________________________________________| Salivary Glands | + + + + + + + + + + + + + + + + + M + + + + + + +| Artery, Inflammation, Chronic Active | | __________________________________________________________________________| Stomach, Forestomach | + + + + + + + + + + + + + + + + + + + + + + + + +| Hyperplasia, Basal Cell | 2 | __________________________________________________________________________| Stomach, Glandular | + + + + + + + + + + + + + + + + + + + + + + + + +| Inflammation, Chronic Active | 1 | Ulcer | 2 X | _____________________________________________________________________________________________________________________| CARDIOVASCULAR SYSTEM | | | | __________________________________________________________________________| Heart | + + + + + + + + + + + + + + + + + + + + + + + + +| Mineralization | 2 | Artery, Mineralization | 2 | _____________________________________________________________________________________________________________________| ENDOCRINE SYSTEM | | | | __________________________________________________________________________| Adrenal Cortex | + + + + + + + + + + + + + + + + + + + + + + + + +| Accessory Adrenal Cortical Nodule | X | Hyperplasia | | Capsule, Hyperplasia | | __________________________________________________________________________| Adrenal Medulla | + + + + + + M + + + + + + + + + + + + + M + + + +| __________________________________________________________________________| Islets, Pancreatic | + + + + + + + + + + + + + + + + + + + + + + + + +| Hyperplasia | 2 | _____________________________________________________________________________________________________________________| Page 5 NTP Experiment-Test: 05108-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:51:25 _____________________________________________________________________________________________________________________ | 4| 7| 7| 4| 7| 7| 7| 7| 5| 7| 6| 7| 7| 7| 7| 4| 7| 7| 7| 4| 7| 7| 6| 7| 4| DAY ON TEST | 6| 4| 4| 6| 4| 4| 4| 4| 8| 4| 2| 1| 4| 0| 4| 6| 2| 4| 4| 6| 4| 4| 0| 4| 6| | 4| 3| 3| 4| 4| 3| 3| 4| 2| 3| 2| 8| 3| 7| 3| 2| 8| 3| 3| 2| 3| 3| 1| 3| 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| B6C3F1 MICE FEMALE | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 3| 3| 3| 3| 3| 3| ANIMAL ID | 8| 8| 8| 8| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 0| 0| 0| 0| 0| 0| VEHICLE | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| FEMALE | 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| _____________________________________________________________________________________________________________________| ENDOCRINE SYSTEM - cont | | | | __________________________________________________________________________| Parathyroid Gland | + M + + + M + + + + + M + + + M + + + + + + + + +| __________________________________________________________________________| Pituitary Gland | + + + + + + + + + + + + + + + + + M + + + + + + +| Pars Distalis, Angiectasis | 2 2 | Pars Distalis, Hyperplasia | 2 2 2 2 | __________________________________________________________________________| Thyroid Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| Follicle, Cyst | X | Follicular Cell, Hyperplasia | 1 3 | _____________________________________________________________________________________________________________________| GENERAL BODY SYSTEM | | | | None | | _____________________________________________________________________________________________________________________| GENITAL SYSTEM | | | | __________________________________________________________________________| Clitoral Gland | + | Dilatation | 2 | __________________________________________________________________________| Ovary | + + + + + + + + + + + + + + + + + + + + + + + + +| Angiectasis | 2 2 | Cyst | X X X X X X X | Hemorrhage | | Hyperplasia | 2 | Mineralization | | Pigmentation | | Thrombosis | 4 | __________________________________________________________________________| Uterus | + + + + + + + + + + + + + + + + + + + + + + + + +| Hemorrhage | | Endometrium, Hyperplasia | 2| _____________________________________________________________________________________________________________________| HEMATOPOIETIC SYSTEM | | | | __________________________________________________________________________| Bone Marrow | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Lymph Node | + | __________________________________________________________________________| Lymph Node, Mandibular | + M + + + + + + + + + + + + + + + M + + + + + + +| Inflammation, Granulomatous | | __________________________________________________________________________| Lymph Node, Mesenteric | + + + + + + + + + + M + + + + + + M + + + + + + +| Hemorrhage | | Inflammation, Granulomatous | | __________________________________________________________________________| Spleen | + + + + + + + + + + + + + + + + + M + + + + + + +| Amyloid Deposition | | Hematopoietic Cell Proliferation | 2 3 | __________________________________________________________________________| Thymus | + + + + + + + + + + M + + + + + + M + + + + + M +| _____________________________________________________________________________________________________________________| INTEGUMENTARY SYSTEM | | | | __________________________________________________________________________| Mammary Gland | M + + + M + M + + M + + + + + + + M + + + + + + +| __________________________________________________________________________| Skin | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| MUSCULOSKELETAL SYSTEM | | | | _____________________________________________________________________________________________________________________| Page 6 NTP Experiment-Test: 05108-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:51:25 _____________________________________________________________________________________________________________________ | 4| 7| 7| 4| 7| 7| 7| 7| 5| 7| 6| 7| 7| 7| 7| 4| 7| 7| 7| 4| 7| 7| 6| 7| 4| DAY ON TEST | 6| 4| 4| 6| 4| 4| 4| 4| 8| 4| 2| 1| 4| 0| 4| 6| 2| 4| 4| 6| 4| 4| 0| 4| 6| | 4| 3| 3| 4| 4| 3| 3| 4| 2| 3| 2| 8| 3| 7| 3| 2| 8| 3| 3| 2| 3| 3| 1| 3| 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| B6C3F1 MICE FEMALE | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 3| 3| 3| 3| 3| 3| ANIMAL ID | 8| 8| 8| 8| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 0| 0| 0| 0| 0| 0| VEHICLE | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| FEMALE | 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| _____________________________________________________________________________________________________________________| MUSCULOSKELETAL SYSTEM - cont | | | | __________________________________________________________________________| Bone | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| NERVOUS SYSTEM | | | | __________________________________________________________________________| Brain | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Spinal Cord | | _____________________________________________________________________________________________________________________| RESPIRATORY SYSTEM | | | | __________________________________________________________________________| Lung | + + + + + + + + + + + + + + + + + + + + + + + + +| Hemorrhage | 1 | Infiltration Cellular, Histiocyte | 3 | Alveolar Epithelium, Hyperplasia | 1| Mediastinum, Inflammation, | | Granulomatous | | __________________________________________________________________________| Nose | + + + + + + + + + + + + + + + + + + + + M + + + +| __________________________________________________________________________| Trachea | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| SPECIAL SENSES SYSTEM | | | | __________________________________________________________________________| Harderian Gland | + | _____________________________________________________________________________________________________________________| URINARY SYSTEM | | | | __________________________________________________________________________| Kidney | + + + + + + + + + + + + + + + + + + + + + + + + +| Inflammation, Granulomatous | | Nephropathy | 1 1 | Artery, Inflammation, Chronic Active | | __________________________________________________________________________| Urinary Bladder | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| Page 7 NTP Experiment-Test: 05108-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:51:25 __________________________________________________________________________________________________________________________________ | 4| 7| 7| 7| 7| 7| 7| 7| 7| 6| | | DAY ON TEST | 4| 4| 4| 4| 4| 4| 4| 4| 4| 9| | | | 2| 4| 4| 3| 4| 4| 4| 4| 3| 3| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | B6C3F1 MICE FEMALE | 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| | T | ANIMAL ID | 0| 0| 0| 0| 1| 1| 1| 1| 1| 1| | A | VEHICLE | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| | L | FEMALE | 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| | | __________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM | | | | | | __________________________________________________________________________|____________| Esophagus | + + + + + + + + + + | 60 | __________________________________________________________________________|____________| Gallbladder | + + + + + + + + + + | 56 | __________________________________________________________________________|____________| Intestine Large, Colon | + + + + + + + + + + | 60 | __________________________________________________________________________|____________| Intestine Large, Rectum | + + + + + + + + + + | 57 | __________________________________________________________________________|____________| Intestine Large, Cecum | + + + + + + + + + A | 59 | __________________________________________________________________________|____________| Intestine Small, Duodenum | + + + + + + + + + A | 58 | __________________________________________________________________________|____________| Intestine Small, Jejunum | + + + + + + + + + A | 56 | Erosion | | 1 2.0| Inflammation, Chronic Active | | 1 3.0| __________________________________________________________________________|____________| Intestine Small, Ileum | + + + + + + + + + + | 58 | __________________________________________________________________________|____________| Liver | + + + + + + + + + + | 60 | Basophilic Focus | X | 1 | Eosinophilic Focus | X | 6 | Fatty Change, Focal | | 1 1.0| Inflammation, Granulomatous | | 1 3.0| Mixed Cell Focus | X | 4 | Necrosis | | 2 1.0| Vacuolization Cytoplasmic, Focal | | 1 2.0| __________________________________________________________________________|____________| Mesentery | | 4 | Inflammation, Granulomatous | | 1 3.0| Fat, Necrosis | | 2 3.0| __________________________________________________________________________|____________| Pancreas | + + + + + + + + + + | 60 | Artery, Inflammation, Chronic Active | | 1 2.0| __________________________________________________________________________|____________| Salivary Glands | + + + + + + + + + + | 59 | Artery, Inflammation, Chronic Active | | 1 2.0| __________________________________________________________________________|____________| Stomach, Forestomach | + + + + + + + + + + | 60 | Hyperplasia, Basal Cell | | 1 2.0| __________________________________________________________________________|____________| Stomach, Glandular | + + + + + + + + + + | 59 | Inflammation, Chronic Active | | 2 1.5| Ulcer | | 2 2.0| _____________________________________________________________________________________________________________________| | CARDIOVASCULAR SYSTEM | | | | | | __________________________________________________________________________|____________| Heart | + + + + + + + + + + | 60 | Mineralization | | 1 2.0| Artery, Mineralization | | 1 2.0| _____________________________________________________________________________________________________________________| | ENDOCRINE SYSTEM | | | | | | __________________________________________________________________________|____________| Adrenal Cortex | + + + + + + + + + + | 60 | Accessory Adrenal Cortical Nodule | | 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 8 NTP Experiment-Test: 05108-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:51:25 __________________________________________________________________________________________________________________________________ | 4| 7| 7| 7| 7| 7| 7| 7| 7| 6| | | DAY ON TEST | 4| 4| 4| 4| 4| 4| 4| 4| 4| 9| | | | 2| 4| 4| 3| 4| 4| 4| 4| 3| 3| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | B6C3F1 MICE FEMALE | 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| | T | ANIMAL ID | 0| 0| 0| 0| 1| 1| 1| 1| 1| 1| | A | VEHICLE | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| | L | FEMALE | 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| | | __________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM - cont | | | | | | Hyperplasia | 2 | 1 2.0| Capsule, Hyperplasia | 2 | 1 2.0| __________________________________________________________________________|____________| Adrenal Medulla | + + + + + + + + + + | 56 | __________________________________________________________________________|____________| Islets, Pancreatic | + + + + + + + + + + | 59 | Hyperplasia | | 2 2.0| __________________________________________________________________________|____________| Parathyroid Gland | + + + M + + + + + + | 47 | __________________________________________________________________________|____________| Pituitary Gland | + + + + + + + + + + | 56 | Pars Distalis, Angiectasis | | 3 2.0| Pars Distalis, Hyperplasia | 2 2 | 9 2.0| __________________________________________________________________________|____________| Thyroid Gland | + + + + + + + + + + | 60 | Follicle, Cyst | | 3 | Follicular Cell, Hyperplasia | | 3 2.0| _____________________________________________________________________________________________________________________| | GENERAL BODY SYSTEM | | | | | | None | | | _____________________________________________________________________________________________________________________| | GENITAL SYSTEM | | | | | | __________________________________________________________________________|____________| Clitoral Gland | + | 2 | Dilatation | 2 | 2 2.0| __________________________________________________________________________|____________| Ovary | + + + + + + + + + + | 59 | Angiectasis | | 2 2.0| Cyst | | 10 | Hemorrhage | | 1 3.0| Hyperplasia | | 1 2.0| Mineralization | | 1 2.0| Pigmentation | | 1 2.0| Thrombosis | | 2 3.0| __________________________________________________________________________|____________| Uterus | + + + + + + + + + + | 60 | Hemorrhage | 2 | 1 2.0| Endometrium, Hyperplasia | | 2 2.0| _____________________________________________________________________________________________________________________| | HEMATOPOIETIC SYSTEM | | | | | | __________________________________________________________________________|____________| Bone Marrow | + + + + + + + + + + | 60 | __________________________________________________________________________|____________| Lymph Node | | 4 | __________________________________________________________________________|____________| Lymph Node, Mandibular | + + + + + + + + + + | 58 | Inflammation, Granulomatous | | 1 3.0| __________________________________________________________________________|____________| Lymph Node, Mesenteric | + + + + + + + + M M | 56 | Hemorrhage | | 1 3.0| Inflammation, Granulomatous | | 1 3.0| __________________________________________________________________________________________________________________________________ * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 9 NTP Experiment-Test: 05108-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:51:25 __________________________________________________________________________________________________________________________________ | 4| 7| 7| 7| 7| 7| 7| 7| 7| 6| | | DAY ON TEST | 4| 4| 4| 4| 4| 4| 4| 4| 4| 9| | | | 2| 4| 4| 3| 4| 4| 4| 4| 3| 3| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | B6C3F1 MICE FEMALE | 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| | T | ANIMAL ID | 0| 0| 0| 0| 1| 1| 1| 1| 1| 1| | A | VEHICLE | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| | L | FEMALE | 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| | | __________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - cont | | | | | | __________________________________________________________________________|____________| Spleen | + + + + + + + + + + | 59 | Amyloid Deposition | | 1 3.0| Hematopoietic Cell Proliferation | 3 | 5 2.6| __________________________________________________________________________|____________| Thymus | + + + + + + + + M + | 52 | _____________________________________________________________________________________________________________________| | INTEGUMENTARY SYSTEM | | | | | | __________________________________________________________________________|____________| Mammary Gland | + + + + + + M M M + | 46 | __________________________________________________________________________|____________| Skin | + + + + + + + + + + | 60 | _____________________________________________________________________________________________________________________| | MUSCULOSKELETAL SYSTEM | | | | | | __________________________________________________________________________|____________| Bone | + + + + + + + + + + | 60 | _____________________________________________________________________________________________________________________| | NERVOUS SYSTEM | | | | | | __________________________________________________________________________|____________| Brain | + + + + + + + + + + | 60 | __________________________________________________________________________|____________| Spinal Cord | | 1 | _____________________________________________________________________________________________________________________| | RESPIRATORY SYSTEM | | | | | | __________________________________________________________________________|____________| Lung | + + + + + + + + + + | 60 | Hemorrhage | | 1 1.0| Infiltration Cellular, Histiocyte | | 1 3.0| Alveolar Epithelium, Hyperplasia | | 1 1.0| Mediastinum, Inflammation, | | | Granulomatous | | 1 3.0| __________________________________________________________________________|____________| Nose | + + + + + + + + M + | 57 | __________________________________________________________________________|____________| Trachea | + + + + + + + + + + | 60 | _____________________________________________________________________________________________________________________| | SPECIAL SENSES SYSTEM | | | | | | __________________________________________________________________________|____________| Harderian Gland | + | 3 | _____________________________________________________________________________________________________________________| | URINARY SYSTEM | | | | | | __________________________________________________________________________|____________| Kidney | + + + + + + + + + + | 60 | Inflammation, Granulomatous | | 1 2.0| Nephropathy | | 2 1.0| Artery, Inflammation, Chronic Active | | 1 2.0| __________________________________________________________________________|____________| Urinary Bladder | + + + + + + + + + + | 60 | __________________________________________________________________________________________________________________________________ * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 10 NTP Experiment-Test: 05108-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:51:25 _____________________________________________________________________________________________________________________ | 4| 7| 5| 7| 7| 6| 7| 7| 7| 4| 7| 4| 7| 7| 7| 7| 4| 7| 7| 7| 7| 7| 7| 7| 7| DAY ON TEST | 6| 4| 5| 4| 4| 9| 4| 3| 4| 6| 4| 6| 4| 4| 4| 4| 6| 4| 4| 4| 4| 4| 4| 4| 4| | 2| 2| 4| 2| 2| 4| 2| 2| 2| 2| 2| 4| 2| 2| 2| 2| 4| 2| 2| 2| 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| B6C3F1 MICE FEMALE | 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| ANIMAL ID | 1| 1| 1| 1| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 4| 3.75 | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| MG/KG | 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| _____________________________________________________________________________________________________________________| ALIMENTARY SYSTEM | | | | __________________________________________________________________________| Esophagus | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Gallbladder | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Large, Colon | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Large, Rectum | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Large, Cecum | + + + + + + + + + + + + + + + + + + + + + + + + +| Hyperplasia | | __________________________________________________________________________| Intestine Small, Duodenum | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Small, Jejunum | + + + + + + + + + + + + + + + + + + + + + + + + +| Diverticulum | | __________________________________________________________________________| Intestine Small, Ileum | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Liver | + + + + + + + + + + + + + + + + + + + + + + + + +| Basophilic Focus | X X | Clear Cell Focus | X | Eosinophilic Focus | X X | Hematopoietic Cell Proliferation | | Granulocytic | | Infiltration Cellular, Lymphocyte | 1 1 | Necrosis | 1 1 | __________________________________________________________________________| Mesentery | + | __________________________________________________________________________| Pancreas | + + + + + + + + + + + + + + + + + + + + + + + + +| Acinus, Atrophy | | Duct, Cyst | | Duct, Ectasia | 3 | __________________________________________________________________________| Salivary Glands | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Stomach, Forestomach | + + + + + + + + + + + + + + + + + + + + + + + + +| Acanthosis | 2 | Hyperkeratosis | 2 | Hyperplasia, Basal Cell | | Inflammation, Chronic Active | | __________________________________________________________________________| Stomach, Glandular | + + + + + + + + + + + + + + + + + + + + + + + + +| Hyperplasia | 1 | __________________________________________________________________________| Tongue | | Congestion | | Hemorrhage | | _____________________________________________________________________________________________________________________| CARDIOVASCULAR SYSTEM | | | | __________________________________________________________________________| Heart | + + + + + + + + + + + + + + + + + + + + + + + + +| Mineralization | 2 | _____________________________________________________________________________________________________________________| ENDOCRINE SYSTEM | | | | __________________________________________________________________________| Adrenal Cortex | + + + + + + + + + + + + + + + + + + + + + + + + +| Accessory Adrenal Cortical Nodule | | Hypertrophy | | __________________________________________________________________________| Adrenal Medulla | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| Page 11 NTP Experiment-Test: 05108-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:51:25 _____________________________________________________________________________________________________________________ | 4| 7| 5| 7| 7| 6| 7| 7| 7| 4| 7| 4| 7| 7| 7| 7| 4| 7| 7| 7| 7| 7| 7| 7| 7| DAY ON TEST | 6| 4| 5| 4| 4| 9| 4| 3| 4| 6| 4| 6| 4| 4| 4| 4| 6| 4| 4| 4| 4| 4| 4| 4| 4| | 2| 2| 4| 2| 2| 4| 2| 2| 2| 2| 2| 4| 2| 2| 2| 2| 4| 2| 2| 2| 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| B6C3F1 MICE FEMALE | 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| ANIMAL ID | 1| 1| 1| 1| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 4| 3.75 | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| MG/KG | 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| _____________________________________________________________________________________________________________________| ENDOCRINE SYSTEM - cont | | | | __________________________________________________________________________| Islets, Pancreatic | + + + + + + + + + + + + + + + + + + + + + + + + +| Hyperplasia | 2 | __________________________________________________________________________| Parathyroid Gland | + + + + + + + + M M + + + + + M + + + + + M + + +| __________________________________________________________________________| Pituitary Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| Pars Distalis, Angiectasis | | Pars Distalis, Hyperplasia | 2 2 2 1 2 | __________________________________________________________________________| Thyroid Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| Follicle, Cyst | X | Follicular Cell, Hyperplasia | 2 2 2 | _____________________________________________________________________________________________________________________| GENERAL BODY SYSTEM | | | | None | | _____________________________________________________________________________________________________________________| GENITAL SYSTEM | | | | __________________________________________________________________________| Ovary | + + + + + + + + + + + + + + + + + + + + + + + + +| Cyst | X X X X X | __________________________________________________________________________| Uterus | + + + + + + + + + + + + + + + + + + + + + + + + +| Endometrium, Hyperplasia | 2 2 | _____________________________________________________________________________________________________________________| HEMATOPOIETIC SYSTEM | | | | __________________________________________________________________________| Blood | + | __________________________________________________________________________| Bone Marrow | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Lymph Node | + + | Mediastinal, Hematopoietic Cell | | Proliferation | | __________________________________________________________________________| Lymph Node, Mandibular | + + + + + + + + + + + + + + + + + + + + + + + M +| Hematopoietic Cell Proliferation | | __________________________________________________________________________| Lymph Node, Mesenteric | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Spleen | + + + + + + + + + + + + + + + + + + + + + + + + +| Hematopoietic Cell Proliferation | 3 2 2 2 | __________________________________________________________________________| Thymus | + + + + + + + M + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| INTEGUMENTARY SYSTEM | | | | __________________________________________________________________________| Mammary Gland | + + + + + + M + + + + M + + M M + + + + + + + + +| __________________________________________________________________________| Skin | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| MUSCULOSKELETAL SYSTEM | | | | __________________________________________________________________________| Bone | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Skeletal Muscle | | _____________________________________________________________________________________________________________________| NERVOUS SYSTEM | | | | __________________________________________________________________________| Brain | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| RESPIRATORY SYSTEM | | | | _____________________________________________________________________________________________________________________| Page 12 NTP Experiment-Test: 05108-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:51:25 _____________________________________________________________________________________________________________________ | 4| 7| 5| 7| 7| 6| 7| 7| 7| 4| 7| 4| 7| 7| 7| 7| 4| 7| 7| 7| 7| 7| 7| 7| 7| DAY ON TEST | 6| 4| 5| 4| 4| 9| 4| 3| 4| 6| 4| 6| 4| 4| 4| 4| 6| 4| 4| 4| 4| 4| 4| 4| 4| | 2| 2| 4| 2| 2| 4| 2| 2| 2| 2| 2| 4| 2| 2| 2| 2| 4| 2| 2| 2| 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| B6C3F1 MICE FEMALE | 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| ANIMAL ID | 1| 1| 1| 1| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 4| 3.75 | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| MG/KG | 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| _____________________________________________________________________________________________________________________| RESPIRATORY SYSTEM - cont | | | | __________________________________________________________________________| Lung | + + + + + + + + + + + + + + + + + + + + + + + + +| Hemorrhage | 2 2 2 1 | Alveolar Epithelium, Hyperplasia | 1 2 2 | __________________________________________________________________________| Nose | + + + + + + + + + + + + + + + + + + M + + + + + +| __________________________________________________________________________| Trachea | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| SPECIAL SENSES SYSTEM | | | | __________________________________________________________________________| Eye | + | Cornea, Inflammation, Acute | 2 | __________________________________________________________________________| Harderian Gland | + + | _____________________________________________________________________________________________________________________| URINARY SYSTEM | | | | __________________________________________________________________________| Kidney | + + + + + + + + + + + + + + + + + + + + + + + + +| Metaplasia, Osseous | | __________________________________________________________________________| Urinary Bladder | + + + + + M + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| Page 13 NTP Experiment-Test: 05108-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:51:25 _____________________________________________________________________________________________________________________ | 7| 7| 7| 7| 7| 6| 7| 7| 7| 7| 7| 7| 7| 4| 4| 6| 7| 4| 4| 7| 7| 7| 7| 7| 7| DAY ON TEST | 4| 4| 4| 4| 4| 7| 4| 4| 2| 4| 4| 4| 4| 6| 6| 9| 4| 6| 6| 4| 4| 4| 1| 4| 4| | 2| 2| 2| 2| 2| 7| 2| 2| 5| 2| 2| 2| 2| 4| 2| 3| 2| 4| 2| 2| 3| 3| 0| 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| B6C3F1 MICE FEMALE | 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| ANIMAL ID | 4| 4| 4| 4| 4| 4| 4| 4| 4| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 6| 3.75 | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| MG/KG | 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| _____________________________________________________________________________________________________________________| ALIMENTARY SYSTEM | | | | __________________________________________________________________________| Esophagus | + + + + + + + + + + + + + + + + + + + + + + + M +| __________________________________________________________________________| Gallbladder | + + + + + M + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Large, Colon | + + + + + A + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Large, Rectum | + + + + + A + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Large, Cecum | + + + + + A + + + + + + + + + + + + + + + + + + +| Hyperplasia | | __________________________________________________________________________| Intestine Small, Duodenum | + + + + + A + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Small, Jejunum | + + + + + A + + + + + + + + + + + + + + + + + + +| Diverticulum | 2 | __________________________________________________________________________| Intestine Small, Ileum | + + + + + A + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Liver | + + + + + + + + + + + + + + + + + + + + + + + + +| Basophilic Focus | | Clear Cell Focus | | Eosinophilic Focus | X | Hematopoietic Cell Proliferation | | Granulocytic | 2 | Infiltration Cellular, Lymphocyte | | Necrosis | | __________________________________________________________________________| Mesentery | | __________________________________________________________________________| Pancreas | + + + + + M + + + + + + + + + + + + + + + + + + +| Acinus, Atrophy | 3 | Duct, Cyst | X | Duct, Ectasia | | __________________________________________________________________________| Salivary Glands | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Stomach, Forestomach | + + + + + + + + + + + + + + + + + + + + + + + + +| Acanthosis | 1 | Hyperkeratosis | 2 | Hyperplasia, Basal Cell | 2 2| Inflammation, Chronic Active | 2| __________________________________________________________________________| Stomach, Glandular | + + + + + A + + + + + + + + + + + + + + + + + + +| Hyperplasia | | __________________________________________________________________________| Tongue | + | Congestion | 2 | Hemorrhage | 2 | _____________________________________________________________________________________________________________________| CARDIOVASCULAR SYSTEM | | | | __________________________________________________________________________| Heart | + + + + + + + + + + + + + + + + + + + + + + + + +| Mineralization | | _____________________________________________________________________________________________________________________| ENDOCRINE SYSTEM | | | | __________________________________________________________________________| Adrenal Cortex | + + + + + + + + + + + + + + + + + + + + + + + + +| Accessory Adrenal Cortical Nodule | X | Hypertrophy | 2 | __________________________________________________________________________| Adrenal Medulla | + + + + + M + + + + + + + + + M + + + + + + + + +| _____________________________________________________________________________________________________________________| Page 14 NTP Experiment-Test: 05108-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:51:25 _____________________________________________________________________________________________________________________ | 7| 7| 7| 7| 7| 6| 7| 7| 7| 7| 7| 7| 7| 4| 4| 6| 7| 4| 4| 7| 7| 7| 7| 7| 7| DAY ON TEST | 4| 4| 4| 4| 4| 7| 4| 4| 2| 4| 4| 4| 4| 6| 6| 9| 4| 6| 6| 4| 4| 4| 1| 4| 4| | 2| 2| 2| 2| 2| 7| 2| 2| 5| 2| 2| 2| 2| 4| 2| 3| 2| 4| 2| 2| 3| 3| 0| 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| B6C3F1 MICE FEMALE | 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| ANIMAL ID | 4| 4| 4| 4| 4| 4| 4| 4| 4| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 6| 3.75 | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| MG/KG | 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| _____________________________________________________________________________________________________________________| ENDOCRINE SYSTEM - cont | | | | __________________________________________________________________________| Islets, Pancreatic | + + + + + M + + + + + + + + + + + + + + + + + + +| Hyperplasia | | __________________________________________________________________________| Parathyroid Gland | + + + + + M M + + + + + + + M + M M + M + M M + +| __________________________________________________________________________| Pituitary Gland | + + + + + + + + + + M + + + + + + + + + + + + + +| Pars Distalis, Angiectasis | | Pars Distalis, Hyperplasia | 2 2 2 2 3 2| __________________________________________________________________________| Thyroid Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| Follicle, Cyst | | Follicular Cell, Hyperplasia | 1 | _____________________________________________________________________________________________________________________| GENERAL BODY SYSTEM | | | | None | | _____________________________________________________________________________________________________________________| GENITAL SYSTEM | | | | __________________________________________________________________________| Ovary | + M + + + + + + + + + + + + + + + + + + + + + + +| Cyst | X X X X X| __________________________________________________________________________| Uterus | + + + + + + + + + + + + + + + + + + + + + + + + +| Endometrium, Hyperplasia | 2 | _____________________________________________________________________________________________________________________| HEMATOPOIETIC SYSTEM | | | | __________________________________________________________________________| Blood | | __________________________________________________________________________| Bone Marrow | + + + + + A + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Lymph Node | + + + + | Mediastinal, Hematopoietic Cell | | Proliferation | 2 | __________________________________________________________________________| Lymph Node, Mandibular | + + + + + + + + + + + + M + + + + + + + + + + + +| Hematopoietic Cell Proliferation | 2 | __________________________________________________________________________| Lymph Node, Mesenteric | + + + + + M + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Spleen | + + + + + M + + + + + + + + + + + + + + + + + + +| Hematopoietic Cell Proliferation | 3 2 | __________________________________________________________________________| Thymus | + + + + + M + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| INTEGUMENTARY SYSTEM | | | | __________________________________________________________________________| Mammary Gland | + + + + M M + + M + + + + + + + + M + + M M + + +| __________________________________________________________________________| Skin | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| MUSCULOSKELETAL SYSTEM | | | | __________________________________________________________________________| Bone | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Skeletal Muscle | + | _____________________________________________________________________________________________________________________| NERVOUS SYSTEM | | | | __________________________________________________________________________| Brain | + + + + + + M + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| RESPIRATORY SYSTEM | | | | _____________________________________________________________________________________________________________________| Page 15 NTP Experiment-Test: 05108-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:51:25 _____________________________________________________________________________________________________________________ | 7| 7| 7| 7| 7| 6| 7| 7| 7| 7| 7| 7| 7| 4| 4| 6| 7| 4| 4| 7| 7| 7| 7| 7| 7| DAY ON TEST | 4| 4| 4| 4| 4| 7| 4| 4| 2| 4| 4| 4| 4| 6| 6| 9| 4| 6| 6| 4| 4| 4| 1| 4| 4| | 2| 2| 2| 2| 2| 7| 2| 2| 5| 2| 2| 2| 2| 4| 2| 3| 2| 4| 2| 2| 3| 3| 0| 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| B6C3F1 MICE FEMALE | 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| ANIMAL ID | 4| 4| 4| 4| 4| 4| 4| 4| 4| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 6| 3.75 | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| MG/KG | 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| _____________________________________________________________________________________________________________________| RESPIRATORY SYSTEM - cont | | | | __________________________________________________________________________| Lung | + + + + + + + + + + + + + + + + + + + + + + + + +| Hemorrhage | | Alveolar Epithelium, Hyperplasia | | __________________________________________________________________________| Nose | + + + + + + + + + + + + + + + + + M + + + + + + +| __________________________________________________________________________| Trachea | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| SPECIAL SENSES SYSTEM | | | | __________________________________________________________________________| Eye | | Cornea, Inflammation, Acute | | __________________________________________________________________________| Harderian Gland | + + +| _____________________________________________________________________________________________________________________| URINARY SYSTEM | | | | __________________________________________________________________________| Kidney | + + + + + + + + + + + + + + + + + + + + + + + + +| Metaplasia, Osseous | | __________________________________________________________________________| Urinary Bladder | + + + + + A + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| Page 16 NTP Experiment-Test: 05108-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:51:25 __________________________________________________________________________________________________________________________________ | 7| 7| 7| 7| 4| 7| 7| 7| 7| 4| | | DAY ON TEST | 4| 4| 2| 4| 6| 4| 4| 4| 4| 6| | | | 3| 3| 2| 3| 4| 3| 3| 3| 2| 4| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | B6C3F1 MICE FEMALE | 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| | T | ANIMAL ID | 6| 6| 6| 6| 7| 7| 7| 7| 7| 7| | A | 3.75 | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| | L | MG/KG | 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| | | __________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM | | | | | | __________________________________________________________________________|____________| Esophagus | + + + + + + + + + + | 59 | __________________________________________________________________________|____________| Gallbladder | + + + + + + + + + + | 59 | __________________________________________________________________________|____________| Intestine Large, Colon | + + + + + + + + + + | 59 | __________________________________________________________________________|____________| Intestine Large, Rectum | + + + + + + + + + + | 59 | __________________________________________________________________________|____________| Intestine Large, Cecum | + + + + + + + + + + | 59 | Hyperplasia | 1 | 1 1.0| __________________________________________________________________________|____________| Intestine Small, Duodenum | + + + + + + + + + + | 59 | __________________________________________________________________________|____________| Intestine Small, Jejunum | + + + + + + + + + + | 59 | Diverticulum | | 1 2.0| __________________________________________________________________________|____________| Intestine Small, Ileum | + + + + + + + + + + | 59 | __________________________________________________________________________|____________| Liver | + + + + + + + + + + | 60 | Basophilic Focus | | 2 | Clear Cell Focus | | 1 | Eosinophilic Focus | | 3 | Hematopoietic Cell Proliferation | | | Granulocytic | | 1 2.0| Infiltration Cellular, Lymphocyte | | 2 1.0| Necrosis | 1 | 3 1.0| __________________________________________________________________________|____________| Mesentery | | 1 | __________________________________________________________________________|____________| Pancreas | + + + + + + + + + + | 59 | Acinus, Atrophy | | 1 3.0| Duct, Cyst | | 1 | Duct, Ectasia | | 1 3.0| __________________________________________________________________________|____________| Salivary Glands | + + + + + + + + + + | 60 | __________________________________________________________________________|____________| Stomach, Forestomach | + + + + + + + + + + | 60 | Acanthosis | | 2 1.5| Hyperkeratosis | | 2 2.0| Hyperplasia, Basal Cell | | 2 2.0| Inflammation, Chronic Active | | 1 2.0| __________________________________________________________________________|____________| Stomach, Glandular | + + + + + + + + + + | 59 | Hyperplasia | | 1 1.0| __________________________________________________________________________|____________| Tongue | | 1 | Congestion | | 1 2.0| Hemorrhage | | 1 2.0| _____________________________________________________________________________________________________________________| | CARDIOVASCULAR SYSTEM | | | | | | __________________________________________________________________________|____________| Heart | + + + + + + + + + + | 60 | Mineralization | | 1 2.0| _____________________________________________________________________________________________________________________| | ENDOCRINE SYSTEM | | | __________________________________________________________________________________________________________________________________ * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 17 NTP Experiment-Test: 05108-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:51:25 __________________________________________________________________________________________________________________________________ | 7| 7| 7| 7| 4| 7| 7| 7| 7| 4| | | DAY ON TEST | 4| 4| 2| 4| 6| 4| 4| 4| 4| 6| | | | 3| 3| 2| 3| 4| 3| 3| 3| 2| 4| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | B6C3F1 MICE FEMALE | 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| | T | ANIMAL ID | 6| 6| 6| 6| 7| 7| 7| 7| 7| 7| | A | 3.75 | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| | L | MG/KG | 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| | | __________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM - cont | | | | | | | | | __________________________________________________________________________|____________| Adrenal Cortex | + + + + + + + + + + | 60 | Accessory Adrenal Cortical Nodule | | 1 | Hypertrophy | | 1 2.0| __________________________________________________________________________|____________| Adrenal Medulla | + + + + + + + + + + | 58 | __________________________________________________________________________|____________| Islets, Pancreatic | + + + + + + + + + + | 59 | Hyperplasia | | 1 2.0| __________________________________________________________________________|____________| Parathyroid Gland | + + + + + + + + M + | 47 | __________________________________________________________________________|____________| Pituitary Gland | + + + + + + + + + + | 59 | Pars Distalis, Angiectasis | 2 | 1 2.0| Pars Distalis, Hyperplasia | 1 1 2 | 14 1.9| __________________________________________________________________________|____________| Thyroid Gland | + + + + + + + + + + | 60 | Follicle, Cyst | | 1 | Follicular Cell, Hyperplasia | 2 | 5 1.8| _____________________________________________________________________________________________________________________| | GENERAL BODY SYSTEM | | | | | | None | | | _____________________________________________________________________________________________________________________| | GENITAL SYSTEM | | | | | | __________________________________________________________________________|____________| Ovary | + + + + + + + + + + | 59 | Cyst | X X X | 13 | __________________________________________________________________________|____________| Uterus | + + + + + + + + + + | 60 | Endometrium, Hyperplasia | | 3 2.0| _____________________________________________________________________________________________________________________| | HEMATOPOIETIC SYSTEM | | | | | | __________________________________________________________________________|____________| Blood | | 1 | __________________________________________________________________________|____________| Bone Marrow | + + + + + + + + + + | 59 | __________________________________________________________________________|____________| Lymph Node | + | 7 | Mediastinal, Hematopoietic Cell | | | Proliferation | | 1 2.0| __________________________________________________________________________|____________| Lymph Node, Mandibular | + + + + + + + + + + | 58 | Hematopoietic Cell Proliferation | | 1 2.0| __________________________________________________________________________|____________| Lymph Node, Mesenteric | + + + + + + + + + + | 59 | __________________________________________________________________________|____________| Spleen | + + + + + + + + + + | 59 | Hematopoietic Cell Proliferation | 3 | 7 2.4| __________________________________________________________________________|____________| Thymus | + + + + + + + + + + | 58 | _____________________________________________________________________________________________________________________| | INTEGUMENTARY SYSTEM | | | | | | __________________________________________________________________________|____________| Mammary Gland | + + + M M M + + + + | 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 18 NTP Experiment-Test: 05108-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:51:25 __________________________________________________________________________________________________________________________________ | 7| 7| 7| 7| 4| 7| 7| 7| 7| 4| | | DAY ON TEST | 4| 4| 2| 4| 6| 4| 4| 4| 4| 6| | | | 3| 3| 2| 3| 4| 3| 3| 3| 2| 4| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | B6C3F1 MICE FEMALE | 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| | T | ANIMAL ID | 6| 6| 6| 6| 7| 7| 7| 7| 7| 7| | A | 3.75 | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| | L | MG/KG | 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| | | __________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM - cont | | | | | | __________________________________________________________________________|____________| Skin | + + + + M + + + + + | 59 | _____________________________________________________________________________________________________________________| | MUSCULOSKELETAL SYSTEM | | | | | | __________________________________________________________________________|____________| Bone | + + + + + + + + + + | 60 | __________________________________________________________________________|____________| Skeletal Muscle | | 1 | _____________________________________________________________________________________________________________________| | NERVOUS SYSTEM | | | | | | __________________________________________________________________________|____________| Brain | + + + + + + + + + + | 59 | _____________________________________________________________________________________________________________________| | RESPIRATORY SYSTEM | | | | | | __________________________________________________________________________|____________| Lung | + + + + + + + + + + | 60 | Hemorrhage | | 4 1.8| Alveolar Epithelium, Hyperplasia | | 3 1.7| __________________________________________________________________________|____________| Nose | + + + + + + + + + + | 58 | __________________________________________________________________________|____________| Trachea | + + + + + + + + + + | 60 | _____________________________________________________________________________________________________________________| | SPECIAL SENSES SYSTEM | | | | | | __________________________________________________________________________|____________| Eye | | 1 | Cornea, Inflammation, Acute | | 1 2.0| __________________________________________________________________________|____________| Harderian Gland | | 5 | _____________________________________________________________________________________________________________________| | URINARY SYSTEM | | | | | | __________________________________________________________________________|____________| Kidney | + + + + + + + + + + | 60 | Metaplasia, Osseous | 1 | 1 1.0| __________________________________________________________________________|____________| Urinary Bladder | + + + + + + + + + + | 58 | __________________________________________________________________________________________________________________________________ * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 19 NTP Experiment-Test: 05108-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:51:25 _____________________________________________________________________________________________________________________ | 4| 4| 4| 7| 7| 3| 7| 7| 7| 7| 7| 7| 6| 7| 4| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| DAY ON TEST | 6| 6| 6| 4| 4| 8| 4| 3| 3| 3| 3| 3| 4| 3| 6| 3| 3| 0| 3| 3| 4| 4| 4| 4| 4| | 4| 2| 2| 1| 1| 8| 1| 8| 8| 8| 8| 8| 0| 8| 4| 8| 8| 7| 8| 8| 1| 1| 1| 1| 1| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| B6C3F1 MICE FEMALE | 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 4| ANIMAL ID | 7| 7| 7| 7| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 0| 7.5 | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| MG/KG | 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| _____________________________________________________________________________________________________________________| ALIMENTARY SYSTEM | | | | __________________________________________________________________________| Esophagus | + + + + + + + + + M + + + + + + + + + + + + + + +| __________________________________________________________________________| Gallbladder | + + + + + + + + + M M + + + + M + + + + + + + + +| __________________________________________________________________________| Intestine Large, Colon | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Large, Rectum | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Large, Cecum | + + + + + + + + + M + + + + + + + + + + + + + + +| Epithelium, Hyperplasia | 1 | __________________________________________________________________________| Intestine Small, Duodenum | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Small, Jejunum | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Small, Ileum | + + + + + + + + + + + + + + + + + + + + + + + + +| Lymphoid Tissue, Hyperplasia | | __________________________________________________________________________| Liver | + + + + + + + + + + + + + + + + + + + + + + + + +| Basophilic Focus | | Clear Cell Focus | | Eosinophilic Focus | X X X | Infiltration Cellular, Lymphocyte | 2 | Inflammation, Focal, Necrotizing | 1 | Mixed Cell Focus | X X | Necrosis | 2 1 | Centrilobular, Hypertrophy | | __________________________________________________________________________| Mesentery | +| Inflammation, Chronic Active | | Fat, Necrosis | | __________________________________________________________________________| Pancreas | + + + + + + + + + + + + + + + + + + + + + + + + +| Duct, Cyst | | __________________________________________________________________________| Salivary Glands | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Stomach, Forestomach | + + + + + + + + + + + + + + + + + + + + + + + + +| Acanthosis | 2 1 | Hyperkeratosis | 1 2 | Hyperplasia, Basal Cell | | Hyperplasia, Squamous | | Inflammation, Chronic Active | | __________________________________________________________________________| Stomach, Glandular | + + + + + + + + + + + + + + + + + + + + + + + + +| Hyperplasia | 1 1 | _____________________________________________________________________________________________________________________| CARDIOVASCULAR SYSTEM | | | | __________________________________________________________________________| Heart | + + + + + + + + + M + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| ENDOCRINE SYSTEM | | | | __________________________________________________________________________| Adrenal Cortex | + + + + + + + + + + + + + + + + + + + + + + + + +| Hypertrophy | 3 | __________________________________________________________________________| Adrenal Medulla | + + + + + + + + + + M + M M + M + + + + + + + + +| __________________________________________________________________________| Islets, Pancreatic | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Parathyroid Gland | + + + + + M + + + M M M + + + M + + + + + + + M +| Infiltration Cellular, Lymphocyte | | _____________________________________________________________________________________________________________________| Page 20 NTP Experiment-Test: 05108-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:51:25 _____________________________________________________________________________________________________________________ | 4| 4| 4| 7| 7| 3| 7| 7| 7| 7| 7| 7| 6| 7| 4| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| DAY ON TEST | 6| 6| 6| 4| 4| 8| 4| 3| 3| 3| 3| 3| 4| 3| 6| 3| 3| 0| 3| 3| 4| 4| 4| 4| 4| | 4| 2| 2| 1| 1| 8| 1| 8| 8| 8| 8| 8| 0| 8| 4| 8| 8| 7| 8| 8| 1| 1| 1| 1| 1| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| B6C3F1 MICE FEMALE | 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 4| ANIMAL ID | 7| 7| 7| 7| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 0| 7.5 | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| MG/KG | 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| _____________________________________________________________________________________________________________________| ENDOCRINE SYSTEM - cont | | | | __________________________________________________________________________| Pituitary Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| Pars Distalis, Angiectasis | | Pars Distalis, Hyperplasia | 2 2 | __________________________________________________________________________| Thyroid Gland | + + + + + + + + + M + + + + + + + + + + + + + + +| Follicular Cell, Hyperplasia | | _____________________________________________________________________________________________________________________| GENERAL BODY SYSTEM | | | | None | | _____________________________________________________________________________________________________________________| GENITAL SYSTEM | | | | __________________________________________________________________________| Ovary | + + + + + + + + + + M + + + + + + + + + + + + + +| Angiectasis | | Atrophy | | Cyst | X X X X | __________________________________________________________________________| Uterus | + + + + + + + + + + + + + + + + + + + + + + + + +| Angiectasis | 1 | Inflammation, Acute | | Endometrium, Hyperplasia, Cystic | | Endometrium, Hyperplasia | 3 3 3 2 | _____________________________________________________________________________________________________________________| HEMATOPOIETIC SYSTEM | | | | __________________________________________________________________________| Bone Marrow | + + + + + + + + + + + + + + + + + + + + + + + + +| Myelofibrosis | | __________________________________________________________________________| Lymph Node | | __________________________________________________________________________| Lymph Node, Mandibular | + + + + + + + + + + + + + + + + + + + + M + + + +| __________________________________________________________________________| Lymph Node, Mesenteric | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Spleen | + + + + + + + + + + + + + + + + + + + + + + + +| Angiectasis | | Hematopoietic Cell Proliferation | 3 | Infarct | | __________________________________________________________________________| Thymus | + + + + + + + + + M + + + + + + + + + + + + M + +| _____________________________________________________________________________________________________________________| INTEGUMENTARY SYSTEM | | | | __________________________________________________________________________| Mammary Gland | M M + M + + + + M + + + + + M M + + + + + M + + +| __________________________________________________________________________| Skin | + + + + + + + + + + + + + + + + + + + + + + + + +| Erosion | 2 | Necrosis | 3 | Subcutaneous Tissue, Inflammation, | | Chronic Active | 2 | _____________________________________________________________________________________________________________________| MUSCULOSKELETAL SYSTEM | | | | __________________________________________________________________________| Bone | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Skeletal Muscle | | Inflammation, Chronic Active | | _____________________________________________________________________________________________________________________| Page 21 NTP Experiment-Test: 05108-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:51:25 _____________________________________________________________________________________________________________________ | 4| 4| 4| 7| 7| 3| 7| 7| 7| 7| 7| 7| 6| 7| 4| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| DAY ON TEST | 6| 6| 6| 4| 4| 8| 4| 3| 3| 3| 3| 3| 4| 3| 6| 3| 3| 0| 3| 3| 4| 4| 4| 4| 4| | 4| 2| 2| 1| 1| 8| 1| 8| 8| 8| 8| 8| 0| 8| 4| 8| 8| 7| 8| 8| 1| 1| 1| 1| 1| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| B6C3F1 MICE FEMALE | 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 4| ANIMAL ID | 7| 7| 7| 7| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 0| 7.5 | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| MG/KG | 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| _____________________________________________________________________________________________________________________| MUSCULOSKELETAL SYSTEM - cont | | | | _____________________________________________________________________________________________________________________| NERVOUS SYSTEM | | | | __________________________________________________________________________| Brain | + + + + + + + + + + + + + + + + + + + + + + + + +| Mineralization | | _____________________________________________________________________________________________________________________| RESPIRATORY SYSTEM | | | | __________________________________________________________________________| Lung | + + + + + + + + + M + + + + + + + + + + + + + + +| Hemorrhage | 2 | Alveolar Epithelium, Hyperplasia | | __________________________________________________________________________| Nose | + + + + + + + + + + + + + + + M + + + + + + + + +| Glands, Cytoplasmic Alteration | | Mucosa, Cytoplasmic Alteration | | __________________________________________________________________________| Trachea | + + + + + + + + + M + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| SPECIAL SENSES SYSTEM | | | | __________________________________________________________________________| Ear | + | __________________________________________________________________________| Harderian Gland | + | _____________________________________________________________________________________________________________________| URINARY SYSTEM | | | | __________________________________________________________________________| Kidney | + + + + + + + + + + + + + + + + + + + + + + + + +| Nephropathy | | Papilla, Mineralization | | __________________________________________________________________________| Urinary Bladder | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| Page 22 NTP Experiment-Test: 05108-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:51:25 _____________________________________________________________________________________________________________________ | 7| 6| 7| 7| 7| 5| 4| 7| 7| 4| 7| 7| 7| 6| 7| 7| 7| 7| 7| 7| 7| 7| 7| 4| 7| DAY ON TEST | 4| 3| 4| 4| 4| 6| 6| 0| 4| 6| 4| 4| 4| 2| 4| 4| 4| 2| 3| 4| 4| 4| 4| 6| 3| | 1| 2| 1| 1| 1| 9| 4| 1| 1| 2| 1| 1| 1| 6| 1| 1| 1| 3| 2| 1| 1| 1| 1| 4| 1| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| B6C3F1 MICE FEMALE | 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| ANIMAL ID | 0| 0| 0| 0| 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 2| 7.5 | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| MG/KG | 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| _____________________________________________________________________________________________________________________| ALIMENTARY SYSTEM | | | | __________________________________________________________________________| Esophagus | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Gallbladder | + + + + + + + + + + + + + A + + + + + + + + + + +| __________________________________________________________________________| Intestine Large, Colon | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Large, Rectum | + + + + + + + + + + + + + + + + + + M + + + + + M| __________________________________________________________________________| Intestine Large, Cecum | + + + + + + + + + + + + + + + + + + + + + + + + +| Epithelium, Hyperplasia | | __________________________________________________________________________| Intestine Small, Duodenum | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Small, Jejunum | + + + + + + + M + + + + + + + + M + + + + + + + +| __________________________________________________________________________| Intestine Small, Ileum | + + + + + + + + + + + + + + + + + + + + + + + + +| Lymphoid Tissue, Hyperplasia | 2 | __________________________________________________________________________| Liver | + + + + + + + + + + + + + + + + + + + + + + + + +| Basophilic Focus | X | Clear Cell Focus | X | Eosinophilic Focus | X X | Infiltration Cellular, Lymphocyte | | Inflammation, Focal, Necrotizing | | Mixed Cell Focus | X X | Necrosis | 1| Centrilobular, Hypertrophy | | __________________________________________________________________________| Mesentery | + + | Inflammation, Chronic Active | 2 | Fat, Necrosis | 3 | __________________________________________________________________________| Pancreas | + + + + + + + + + + + + + + + + + + + + + + + + +| Duct, Cyst | X | __________________________________________________________________________| Salivary Glands | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Stomach, Forestomach | + + + + + + + + + + + + + + + + + + + + + + + + +| Acanthosis | 1 | Hyperkeratosis | 1 | Hyperplasia, Basal Cell | 2| Hyperplasia, Squamous | | Inflammation, Chronic Active | 1| __________________________________________________________________________| Stomach, Glandular | + + + + + + + + + + + + + + + + + + + + + + + + +| Hyperplasia | | _____________________________________________________________________________________________________________________| CARDIOVASCULAR SYSTEM | | | | __________________________________________________________________________| Heart | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| ENDOCRINE SYSTEM | | | | __________________________________________________________________________| Adrenal Cortex | + + + + + + + + + + + + + + + + + + + + + + + + +| Hypertrophy | | __________________________________________________________________________| Adrenal Medulla | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Islets, Pancreatic | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Parathyroid Gland | + + + + + + + + + + + + + M + + + + + + + + + + +| Infiltration Cellular, Lymphocyte | 3 | _____________________________________________________________________________________________________________________| Page 23 NTP Experiment-Test: 05108-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:51:25 _____________________________________________________________________________________________________________________ | 7| 6| 7| 7| 7| 5| 4| 7| 7| 4| 7| 7| 7| 6| 7| 7| 7| 7| 7| 7| 7| 7| 7| 4| 7| DAY ON TEST | 4| 3| 4| 4| 4| 6| 6| 0| 4| 6| 4| 4| 4| 2| 4| 4| 4| 2| 3| 4| 4| 4| 4| 6| 3| | 1| 2| 1| 1| 1| 9| 4| 1| 1| 2| 1| 1| 1| 6| 1| 1| 1| 3| 2| 1| 1| 1| 1| 4| 1| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| B6C3F1 MICE FEMALE | 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| ANIMAL ID | 0| 0| 0| 0| 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 2| 7.5 | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| MG/KG | 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| _____________________________________________________________________________________________________________________| ENDOCRINE SYSTEM - cont | | | | __________________________________________________________________________| Pituitary Gland | + + + + + + + + M + + + + + + + + + + + + + + + +| Pars Distalis, Angiectasis | 2 | Pars Distalis, Hyperplasia | 2 2 2 2 2 2 2| __________________________________________________________________________| Thyroid Gland | + + + + + + + + + + + + + + + + + + + + + + + +| Follicular Cell, Hyperplasia | 1 | _____________________________________________________________________________________________________________________| GENERAL BODY SYSTEM | | | | None | | _____________________________________________________________________________________________________________________| GENITAL SYSTEM | | | | __________________________________________________________________________| Ovary | + + + + + + + + M + + + + + + + + + + + + + + + +| Angiectasis | | Atrophy | 4 | Cyst | X | __________________________________________________________________________| Uterus | + + + + + + + + + + + + + + + + + + + + + + + + +| Angiectasis | | Inflammation, Acute | | Endometrium, Hyperplasia, Cystic | 2 | Endometrium, Hyperplasia | 2 2 2 | _____________________________________________________________________________________________________________________| HEMATOPOIETIC SYSTEM | | | | __________________________________________________________________________| Bone Marrow | + + + + + + + + + + + + + + + + + + + + + + + + +| Myelofibrosis | 2 | __________________________________________________________________________| Lymph Node | + + | __________________________________________________________________________| Lymph Node, Mandibular | + + + + + + + + + + + + + M + + + + + + + + + + +| __________________________________________________________________________| Lymph Node, Mesenteric | + + + + + + + + + + + + + + M + + + + + M + + + +| __________________________________________________________________________| Spleen | + + + + + + + + + + + + + + + + + + + + + + + + +| Angiectasis | 2 | Hematopoietic Cell Proliferation | 2 3 3 3 | Infarct | 3 | __________________________________________________________________________| Thymus | + + + + + + + M + + M + + + + + + + + + + + + + M| _____________________________________________________________________________________________________________________| INTEGUMENTARY SYSTEM | | | | __________________________________________________________________________| Mammary Gland | + + + + + + + + + + + M + + M + + + M + + + + + +| __________________________________________________________________________| Skin | + + + + + + + + + + + + + + + + + + + + + + + + +| Erosion | | Necrosis | | Subcutaneous Tissue, Inflammation, | | Chronic Active | | _____________________________________________________________________________________________________________________| MUSCULOSKELETAL SYSTEM | | | | __________________________________________________________________________| Bone | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Skeletal Muscle | + | Inflammation, Chronic Active | 1 | _____________________________________________________________________________________________________________________| Page 24 NTP Experiment-Test: 05108-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:51:25 _____________________________________________________________________________________________________________________ | 7| 6| 7| 7| 7| 5| 4| 7| 7| 4| 7| 7| 7| 6| 7| 7| 7| 7| 7| 7| 7| 7| 7| 4| 7| DAY ON TEST | 4| 3| 4| 4| 4| 6| 6| 0| 4| 6| 4| 4| 4| 2| 4| 4| 4| 2| 3| 4| 4| 4| 4| 6| 3| | 1| 2| 1| 1| 1| 9| 4| 1| 1| 2| 1| 1| 1| 6| 1| 1| 1| 3| 2| 1| 1| 1| 1| 4| 1| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| B6C3F1 MICE FEMALE | 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| ANIMAL ID | 0| 0| 0| 0| 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 2| 7.5 | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| MG/KG | 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| _____________________________________________________________________________________________________________________| MUSCULOSKELETAL SYSTEM - cont | | | | _____________________________________________________________________________________________________________________| NERVOUS SYSTEM | | | | __________________________________________________________________________| Brain | + + + + + + + + + + + + + + + + + + + + + + + + +| Mineralization | 1 | _____________________________________________________________________________________________________________________| RESPIRATORY SYSTEM | | | | __________________________________________________________________________| Lung | + + + + + + + + + + + + + + + + + + + + + + + + +| Hemorrhage | 2 1 | Alveolar Epithelium, Hyperplasia | 3| __________________________________________________________________________| Nose | + + + + + + + + + + + + + + + + + + M + + + + + +| Glands, Cytoplasmic Alteration | 3 | Mucosa, Cytoplasmic Alteration | 3 | __________________________________________________________________________| Trachea | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| SPECIAL SENSES SYSTEM | | | | __________________________________________________________________________| Ear | | __________________________________________________________________________| Harderian Gland | | _____________________________________________________________________________________________________________________| URINARY SYSTEM | | | | __________________________________________________________________________| Kidney | + + + + + + + + + + + + + + + + + + + + + + + + +| Nephropathy | 1 2 1 | Papilla, Mineralization | | __________________________________________________________________________| Urinary Bladder | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| Page 25 NTP Experiment-Test: 05108-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:51:25 __________________________________________________________________________________________________________________________________ | 7| 7| 7| 4| 6| 7| 3| 7| 4| 7| | | DAY ON TEST | 4| 4| 4| 6| 2| 4| 7| 4| 6| 4| | | | 1| 1| 1| 4| 9| 1| 1| 1| 2| 1| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | B6C3F1 MICE FEMALE | 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| | T | ANIMAL ID | 2| 2| 2| 2| 3| 3| 3| 3| 3| 3| | A | 7.5 | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| | L | MG/KG | 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| | | __________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM | | | | | | __________________________________________________________________________|____________| Esophagus | + + + + M + + + + + | 58 | __________________________________________________________________________|____________| Gallbladder | + + + + + + + + + + | 56 | __________________________________________________________________________|____________| Intestine Large, Colon | + + + + + + + + + + | 60 | __________________________________________________________________________|____________| Intestine Large, Rectum | + + + + + + + + + + | 58 | __________________________________________________________________________|____________| Intestine Large, Cecum | + + + + + + + + + + | 59 | Epithelium, Hyperplasia | 1 1 | 3 1.0| __________________________________________________________________________|____________| Intestine Small, Duodenum | + + + + + + + + + + | 60 | __________________________________________________________________________|____________| Intestine Small, Jejunum | + + + + + + + + + + | 58 | __________________________________________________________________________|____________| Intestine Small, Ileum | + + + + + + + + + + | 60 | Lymphoid Tissue, Hyperplasia | | 1 2.0| __________________________________________________________________________|____________| Liver | + + + + + + + + + + | 60 | Basophilic Focus | X | 2 | Clear Cell Focus | | 1 | Eosinophilic Focus | | 5 | Infiltration Cellular, Lymphocyte | | 1 2.0| Inflammation, Focal, Necrotizing | | 1 1.0| Mixed Cell Focus | | 4 | Necrosis | 1 1 | 5 1.2| Centrilobular, Hypertrophy | 3 | 1 3.0| __________________________________________________________________________|____________| Mesentery | | 3 | Inflammation, Chronic Active | | 1 2.0| Fat, Necrosis | | 1 3.0| __________________________________________________________________________|____________| Pancreas | + + + + + + + + + + | 60 | Duct, Cyst | | 1 | __________________________________________________________________________|____________| Salivary Glands | + + + + + + + + + + | 60 | __________________________________________________________________________|____________| Stomach, Forestomach | + + + + + + + + + + | 60 | Acanthosis | | 3 1.3| Hyperkeratosis | | 3 1.3| Hyperplasia, Basal Cell | | 1 2.0| Hyperplasia, Squamous | 1 | 1 1.0| Inflammation, Chronic Active | | 1 1.0| __________________________________________________________________________|____________| Stomach, Glandular | + + + + + + + + + + | 60 | Hyperplasia | | 2 1.0| _____________________________________________________________________________________________________________________| | CARDIOVASCULAR SYSTEM | | | | | | __________________________________________________________________________|____________| Heart | + + + + + + + + + + | 59 | _____________________________________________________________________________________________________________________| | ENDOCRINE SYSTEM | | | | | | __________________________________________________________________________|____________| Adrenal Cortex | + + + + + + + + + + | 60 | __________________________________________________________________________________________________________________________________ * : 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: 05108-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:51:25 __________________________________________________________________________________________________________________________________ | 7| 7| 7| 4| 6| 7| 3| 7| 4| 7| | | DAY ON TEST | 4| 4| 4| 6| 2| 4| 7| 4| 6| 4| | | | 1| 1| 1| 4| 9| 1| 1| 1| 2| 1| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | B6C3F1 MICE FEMALE | 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| | T | ANIMAL ID | 2| 2| 2| 2| 3| 3| 3| 3| 3| 3| | A | 7.5 | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| | L | MG/KG | 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| | | __________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM - cont | | | | | | Hypertrophy | 2 | 2 2.5| __________________________________________________________________________|____________| Adrenal Medulla | + + + + + + + + + + | 56 | __________________________________________________________________________|____________| Islets, Pancreatic | + + + + + + + + + + | 60 | __________________________________________________________________________|____________| Parathyroid Gland | + + + M M + + M + + | 50 | Infiltration Cellular, Lymphocyte | | 1 3.0| __________________________________________________________________________|____________| Pituitary Gland | + + + + + + + + + + | 59 | Pars Distalis, Angiectasis | | 1 2.0| Pars Distalis, Hyperplasia | | 9 2.0| __________________________________________________________________________|____________| Thyroid Gland | + + + + M + + + + + | 57 | Follicular Cell, Hyperplasia | | 1 1.0| _____________________________________________________________________________________________________________________| | GENERAL BODY SYSTEM | | | | | | None | | | _____________________________________________________________________________________________________________________| | GENITAL SYSTEM | | | | | | __________________________________________________________________________|____________| Ovary | + + + + + + + + + + | 58 | Angiectasis | 2 | 1 2.0| Atrophy | | 1 4.0| Cyst | X | 6 | __________________________________________________________________________|____________| Uterus | + + + + + + + + + + | 60 | Angiectasis | | 1 1.0| Inflammation, Acute | 1 | 1 1.0| Endometrium, Hyperplasia, Cystic | 2 | 2 2.0| Endometrium, Hyperplasia | 2 2 | 9 2.3| _____________________________________________________________________________________________________________________| | HEMATOPOIETIC SYSTEM | | | | | | __________________________________________________________________________|____________| Bone Marrow | + + + + + + + + + + | 60 | Myelofibrosis | | 1 2.0| __________________________________________________________________________|____________| Lymph Node | + | 3 | __________________________________________________________________________|____________| Lymph Node, Mandibular | + + + + + + + + + + | 58 | __________________________________________________________________________|____________| Lymph Node, Mesenteric | + + + + + + + + + + | 58 | __________________________________________________________________________|____________| Spleen | + + + + + + + + + + | 59 | Angiectasis | | 1 2.0| Hematopoietic Cell Proliferation | | 5 2.8| Infarct | | 1 3.0| __________________________________________________________________________|____________| Thymus | + + + + + + + + + + | 55 | _____________________________________________________________________________________________________________________| | INTEGUMENTARY SYSTEM | | | | | | __________________________________________________________________________|____________| Mammary Gland | + M + + + + + + + M | 48 | __________________________________________________________________________________________________________________________________ * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 27 NTP Experiment-Test: 05108-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:51:25 __________________________________________________________________________________________________________________________________ | 7| 7| 7| 4| 6| 7| 3| 7| 4| 7| | | DAY ON TEST | 4| 4| 4| 6| 2| 4| 7| 4| 6| 4| | | | 1| 1| 1| 4| 9| 1| 1| 1| 2| 1| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | B6C3F1 MICE FEMALE | 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| | T | ANIMAL ID | 2| 2| 2| 2| 3| 3| 3| 3| 3| 3| | A | 7.5 | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| | L | MG/KG | 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| | | __________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM - cont | | | | | | __________________________________________________________________________|____________| Skin | + + + + + + + + + + | 60 | Erosion | | 1 2.0| Necrosis | | 1 3.0| Subcutaneous Tissue, Inflammation, | | | Chronic Active | | 1 2.0| _____________________________________________________________________________________________________________________| | MUSCULOSKELETAL SYSTEM | | | | | | __________________________________________________________________________|____________| Bone | + + + + + + + + + + | 60 | __________________________________________________________________________|____________| Skeletal Muscle | + | 2 | Inflammation, Chronic Active | | 1 1.0| _____________________________________________________________________________________________________________________| | NERVOUS SYSTEM | | | | | | __________________________________________________________________________|____________| Brain | + + + + + + + + + + | 60 | Mineralization | | 1 1.0| _____________________________________________________________________________________________________________________| | RESPIRATORY SYSTEM | | | | | | __________________________________________________________________________|____________| Lung | + + + + + + + + + + | 59 | Hemorrhage | 2 | 4 1.8| Alveolar Epithelium, Hyperplasia | | 1 3.0| __________________________________________________________________________|____________| Nose | + + + + + + + + + + | 58 | Glands, Cytoplasmic Alteration | 1 | 2 2.0| Mucosa, Cytoplasmic Alteration | 1 | 2 2.0| __________________________________________________________________________|____________| Trachea | + + + + + + + + + + | 59 | _____________________________________________________________________________________________________________________| | SPECIAL SENSES SYSTEM | | | | | | __________________________________________________________________________|____________| Ear | | 1 | __________________________________________________________________________|____________| Harderian Gland | | 1 | _____________________________________________________________________________________________________________________| | URINARY SYSTEM | | | | | | __________________________________________________________________________|____________| Kidney | + + + + + + + + + + | 60 | Nephropathy | 2 | 4 1.5| Papilla, Mineralization | 1 | 1 1.0| __________________________________________________________________________|____________| Urinary Bladder | + + + + + + + + + + | 60 | __________________________________________________________________________________________________________________________________ * : 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: 05108-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:51:25 _____________________________________________________________________________________________________________________ | 6| 7| 7| 7| 7| 6| 7| 7| 7| 4| 0| 7| 0| 7| 7| 7| 4| 4| 7| 4| 7| 7| 7| 7| 7| DAY ON TEST | 4| 3| 3| 3| 3| 5| 3| 3| 3| 6| 6| 3| 0| 3| 3| 3| 6| 6| 3| 6| 3| 3| 3| 3| 3| | 3| 6| 6| 6| 6| 0| 6| 6| 6| 2| 6| 6| 6| 6| 6| 6| 2| 2| 6| 4| 6| 6| 6| 6| 6| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| B6C3F1 MICE FEMALE | 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| ANIMAL ID | 3| 3| 3| 3| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 6| 15.0 | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| MG/KG | 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| _____________________________________________________________________________________________________________________| ALIMENTARY SYSTEM | | | | __________________________________________________________________________| Esophagus | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Gallbladder | + + + + + + + + + M A + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Large, Colon | + + + + + + + + + + + + + + + + + + + + + + + + +| Artery, Inflammation, Acute | | __________________________________________________________________________| Intestine Large, Rectum | M + + + + + + + + + M + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Large, Cecum | M + + + + + + + + + + + + + + + + + + + + + + + +| Hyperplasia | | Epithelium, Hyperplasia | 1 | __________________________________________________________________________| Intestine Small, Duodenum | M + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Small, Jejunum | M + + M + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Small, Ileum | M + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Liver | + + + + + + + + + + + + + + + + + + + + + + + + +| Basophilic Focus | X X | Eosinophilic Focus | | Hematopoietic Cell Proliferation | | Mixed Cell Focus | X | Necrosis, Focal | | Necrosis | | Vacuolization Cytoplasmic, Focal | | Sinusoid, Centrilobular, Ectasia | | __________________________________________________________________________| Mesentery | + | Fat, Necrosis | 2 | __________________________________________________________________________| Pancreas | M + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Salivary Glands | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Stomach, Forestomach | + + + + + + + + + + + + + + + + + + + + + + + + +| Acanthosis | | Hyperkeratosis | 1 2 | Hyperplasia, Basal Cell | 2 | Hyperplasia, Squamous | 1 | __________________________________________________________________________| Stomach, Glandular | A + + + + + + + + + + + + + + + + + + + + + + + +| Hyperplasia | | Necrosis | 1 | Artery, Inflammation, Acute | | _____________________________________________________________________________________________________________________| CARDIOVASCULAR SYSTEM | | | | __________________________________________________________________________| Heart | + + + + + + + + + + + + + + + + + + + + + + + + +| Mineralization | 2 | Artery, Inflammation, Acute | | _____________________________________________________________________________________________________________________| ENDOCRINE SYSTEM | | | | __________________________________________________________________________| Adrenal Cortex | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Adrenal Medulla | M + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Islets, Pancreatic | M + + + + + + + + + + + + + + + + + + + + + + + +| Hyperplasia | | _____________________________________________________________________________________________________________________| Page 29 NTP Experiment-Test: 05108-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:51:25 _____________________________________________________________________________________________________________________ | 6| 7| 7| 7| 7| 6| 7| 7| 7| 4| 0| 7| 0| 7| 7| 7| 4| 4| 7| 4| 7| 7| 7| 7| 7| DAY ON TEST | 4| 3| 3| 3| 3| 5| 3| 3| 3| 6| 6| 3| 0| 3| 3| 3| 6| 6| 3| 6| 3| 3| 3| 3| 3| | 3| 6| 6| 6| 6| 0| 6| 6| 6| 2| 6| 6| 6| 6| 6| 6| 2| 2| 6| 4| 6| 6| 6| 6| 6| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| B6C3F1 MICE FEMALE | 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| ANIMAL ID | 3| 3| 3| 3| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 6| 15.0 | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| MG/KG | 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| _____________________________________________________________________________________________________________________| ENDOCRINE SYSTEM - cont | | | | __________________________________________________________________________| Parathyroid Gland | + + M + + + M M + M + + M M + M + + + + + + + M +| __________________________________________________________________________| Pituitary Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| Pars Distalis, Angiectasis | 2 2 2 2 | Pars Distalis, Cyst | X | Pars Distalis, Hyperplasia | 2 2 2 2 1 2 | __________________________________________________________________________| Thyroid Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| Follicle, Cyst | | Follicular Cell, Hyperplasia | 2 1 | _____________________________________________________________________________________________________________________| GENERAL BODY SYSTEM | | | | None | | _____________________________________________________________________________________________________________________| GENITAL SYSTEM | | | | __________________________________________________________________________| Clitoral Gland | | Dilatation | | __________________________________________________________________________| Ovary | + + + + + + + + + + + + + + + + + + + + + + + + +| Amyloid Deposition | | Angiectasis | | Cyst | X X | __________________________________________________________________________| Uterus | + + + + + + + + + + + + + + + + + + + + + + + + +| Angiectasis | 2 | Hyperplasia | | Mineralization | 2 | Pigmentation | 2 | Thrombosis | 2 | Endometrium, Hyperplasia | 3 2 3 | _____________________________________________________________________________________________________________________| HEMATOPOIETIC SYSTEM | | | | __________________________________________________________________________| Blood | + | __________________________________________________________________________| Bone Marrow | + + + + + + + + + + + + + + + + + + + + + + + + +| Angiectasis | | __________________________________________________________________________| Lymph Node | + | __________________________________________________________________________| Lymph Node, Mandibular | + + + + M + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Lymph Node, Mesenteric | M + + M + + + + + + + + + + + + + + + + + + + + +| Artery, Inflammation, Acute | | __________________________________________________________________________| Spleen | + + + + + + + + + + + + + + + + + + + + + + + + +| Hematopoietic Cell Proliferation | 3 3 | __________________________________________________________________________| Thymus | + + + + + + + + + + + + + + + + + + + + + + + + +| Hyperplasia | | _____________________________________________________________________________________________________________________| INTEGUMENTARY SYSTEM | | | | __________________________________________________________________________| Mammary Gland | + + M + + + + + + + + + + + + + M + M + + + + + +| __________________________________________________________________________| Skin | + + M + + + + + + + + + + + + + + + + + + + + + +| Necrosis | | _____________________________________________________________________________________________________________________| Page 30 NTP Experiment-Test: 05108-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:51:25 _____________________________________________________________________________________________________________________ | 6| 7| 7| 7| 7| 6| 7| 7| 7| 4| 0| 7| 0| 7| 7| 7| 4| 4| 7| 4| 7| 7| 7| 7| 7| DAY ON TEST | 4| 3| 3| 3| 3| 5| 3| 3| 3| 6| 6| 3| 0| 3| 3| 3| 6| 6| 3| 6| 3| 3| 3| 3| 3| | 3| 6| 6| 6| 6| 0| 6| 6| 6| 2| 6| 6| 6| 6| 6| 6| 2| 2| 6| 4| 6| 6| 6| 6| 6| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| B6C3F1 MICE FEMALE | 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| ANIMAL ID | 3| 3| 3| 3| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 6| 15.0 | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| MG/KG | 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| _____________________________________________________________________________________________________________________| INTEGUMENTARY SYSTEM - cont | | | | _____________________________________________________________________________________________________________________| MUSCULOSKELETAL SYSTEM | | | | __________________________________________________________________________| Bone | + + + + + + + + + + + + + + + + + + + + + + + + +| Fracture | 2 | _____________________________________________________________________________________________________________________| NERVOUS SYSTEM | | | | __________________________________________________________________________| Brain | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Spinal Cord | + | Hemorrhage | 2 | _____________________________________________________________________________________________________________________| RESPIRATORY SYSTEM | | | | __________________________________________________________________________| Lung | + + + + + + + + + + + + + + + + + + + + + + + + +| Hemorrhage | | Alveolar Epithelium, Hyperplasia | | __________________________________________________________________________| Nose | M + + + + + + + M + + + + + + + M + M + + + + + +| __________________________________________________________________________| Trachea | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| SPECIAL SENSES SYSTEM | | | | __________________________________________________________________________| Harderian Gland | | _____________________________________________________________________________________________________________________| URINARY SYSTEM | | | | __________________________________________________________________________| Kidney | + + + + + + + + + + + + + + + + + + + + + + + + +| Glomerulosclerosis | | Nephropathy | | __________________________________________________________________________| Urinary Bladder | A + + + + + + + + + M + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| Page 31 NTP Experiment-Test: 05108-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:51:25 _____________________________________________________________________________________________________________________ | 7| 7| 5| 7| 7| 7| 7| 7| 7| 4| 6| 7| 7| 7| 7| 4| 4| 7| 4| 7| 7| 7| 7| 7| 4| DAY ON TEST | 3| 3| 5| 3| 3| 3| 3| 3| 3| 6| 7| 3| 3| 3| 3| 6| 6| 3| 6| 3| 3| 2| 3| 3| 6| | 6| 6| 4| 6| 6| 6| 6| 6| 6| 4| 9| 7| 7| 8| 7| 4| 4| 7| 2| 7| 4| 2| 7| 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| B6C3F1 MICE FEMALE | 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| ANIMAL ID | 6| 6| 6| 6| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 8| 8| 8| 8| 8| 8| 15.0 | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| MG/KG | 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| _____________________________________________________________________________________________________________________| ALIMENTARY SYSTEM | | | | __________________________________________________________________________| Esophagus | + + + + + + + + + + + + + + M + + + + + + + + + +| __________________________________________________________________________| Gallbladder | + + + + + + + + + + + + + + + + + M + + + + + + +| __________________________________________________________________________| Intestine Large, Colon | + + + + + + + + + + + + + + + + + + + + + + + + +| Artery, Inflammation, Acute | 2 | __________________________________________________________________________| Intestine Large, Rectum | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Large, Cecum | + + + + + + + + + + + + + + + + + + + + + + + + +| Hyperplasia | 1 | Epithelium, Hyperplasia | 1 | __________________________________________________________________________| Intestine Small, Duodenum | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Small, Jejunum | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Small, Ileum | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Liver | + + + + + + + + + + + + + + + + + + + + + + + + +| Basophilic Focus | X | Eosinophilic Focus | X X X | Hematopoietic Cell Proliferation | 2 | Mixed Cell Focus | X X | Necrosis, Focal | 1 | Necrosis | | Vacuolization Cytoplasmic, Focal | 2 | Sinusoid, Centrilobular, Ectasia | 2 | __________________________________________________________________________| Mesentery | | Fat, Necrosis | | __________________________________________________________________________| Pancreas | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Salivary Glands | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Stomach, Forestomach | + + + + + + + + + + + + + + + + + + + + + + + + +| Acanthosis | 2 | Hyperkeratosis | 2 | Hyperplasia, Basal Cell | | Hyperplasia, Squamous | | __________________________________________________________________________| Stomach, Glandular | + + + + + + + + + + + + + + + + + + + + + + + + +| Hyperplasia | 1 | Necrosis | | Artery, Inflammation, Acute | 2 | _____________________________________________________________________________________________________________________| CARDIOVASCULAR SYSTEM | | | | __________________________________________________________________________| Heart | + + + + + + + + + + + + + + + + + + + + + + + + +| Mineralization | 2 1 | Artery, Inflammation, Acute | 2 | _____________________________________________________________________________________________________________________| ENDOCRINE SYSTEM | | | | __________________________________________________________________________| Adrenal Cortex | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Adrenal Medulla | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Islets, Pancreatic | + + + + + + + + + + + + + + + + + + + + + + + + +| Hyperplasia | | _____________________________________________________________________________________________________________________| Page 32 NTP Experiment-Test: 05108-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:51:25 _____________________________________________________________________________________________________________________ | 7| 7| 5| 7| 7| 7| 7| 7| 7| 4| 6| 7| 7| 7| 7| 4| 4| 7| 4| 7| 7| 7| 7| 7| 4| DAY ON TEST | 3| 3| 5| 3| 3| 3| 3| 3| 3| 6| 7| 3| 3| 3| 3| 6| 6| 3| 6| 3| 3| 2| 3| 3| 6| | 6| 6| 4| 6| 6| 6| 6| 6| 6| 4| 9| 7| 7| 8| 7| 4| 4| 7| 2| 7| 4| 2| 7| 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| B6C3F1 MICE FEMALE | 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| ANIMAL ID | 6| 6| 6| 6| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 8| 8| 8| 8| 8| 8| 15.0 | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| MG/KG | 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| _____________________________________________________________________________________________________________________| ENDOCRINE SYSTEM - cont | | | | __________________________________________________________________________| Parathyroid Gland | + + + + + + + + + + + M + + M + + + + + M + M M +| __________________________________________________________________________| Pituitary Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| Pars Distalis, Angiectasis | 2 2 | Pars Distalis, Cyst | | Pars Distalis, Hyperplasia | 2 1 2 | __________________________________________________________________________| Thyroid Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| Follicle, Cyst | X | Follicular Cell, Hyperplasia | | _____________________________________________________________________________________________________________________| GENERAL BODY SYSTEM | | | | None | | _____________________________________________________________________________________________________________________| GENITAL SYSTEM | | | | __________________________________________________________________________| Clitoral Gland | + + | Dilatation | 2 2 | __________________________________________________________________________| Ovary | + + + + M + + + + + + + + + + + + + + + + + + + +| Amyloid Deposition | 2 | Angiectasis | | Cyst | X X X X X X X | __________________________________________________________________________| Uterus | + + + + + + + + + + + + + + + + + + + + + + + + +| Angiectasis | | Hyperplasia | 3 | Mineralization | | Pigmentation | | Thrombosis | | Endometrium, Hyperplasia | 2 2 2 3 | _____________________________________________________________________________________________________________________| HEMATOPOIETIC SYSTEM | | | | __________________________________________________________________________| Blood | | __________________________________________________________________________| Bone Marrow | + + + + + + + + + M + + + + + + + + + + + + + + +| Angiectasis | 2 | __________________________________________________________________________| Lymph Node | + | __________________________________________________________________________| Lymph Node, Mandibular | + + + + + + + + + + + + + + + + + + + + + M + + +| __________________________________________________________________________| Lymph Node, Mesenteric | + + + + + + + + + + + + + + M M + + + + + M + M +| Artery, Inflammation, Acute | 2 | __________________________________________________________________________| Spleen | + + + + + + + + + + + + + + + + + + + + + + + + +| Hematopoietic Cell Proliferation | 3 X 3 | __________________________________________________________________________| Thymus | + + + + + + + + + + + + M + + + + + + + + M + + +| Hyperplasia | 2 | _____________________________________________________________________________________________________________________| INTEGUMENTARY SYSTEM | | | | __________________________________________________________________________| Mammary Gland | + + + + + + + + + M + + M + + M + + + + + + + + +| __________________________________________________________________________| Skin | + + + + + + + + + + + + + + + + + + + + + + + + +| Necrosis | | _____________________________________________________________________________________________________________________| Page 33 NTP Experiment-Test: 05108-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:51:25 _____________________________________________________________________________________________________________________ | 7| 7| 5| 7| 7| 7| 7| 7| 7| 4| 6| 7| 7| 7| 7| 4| 4| 7| 4| 7| 7| 7| 7| 7| 4| DAY ON TEST | 3| 3| 5| 3| 3| 3| 3| 3| 3| 6| 7| 3| 3| 3| 3| 6| 6| 3| 6| 3| 3| 2| 3| 3| 6| | 6| 6| 4| 6| 6| 6| 6| 6| 6| 4| 9| 7| 7| 8| 7| 4| 4| 7| 2| 7| 4| 2| 7| 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| B6C3F1 MICE FEMALE | 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| ANIMAL ID | 6| 6| 6| 6| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 8| 8| 8| 8| 8| 8| 15.0 | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| MG/KG | 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| _____________________________________________________________________________________________________________________| INTEGUMENTARY SYSTEM - cont | | | | _____________________________________________________________________________________________________________________| MUSCULOSKELETAL SYSTEM | | | | __________________________________________________________________________| Bone | + + + + + + + + + + + + + + + + + + + + + + + + +| Fracture | | _____________________________________________________________________________________________________________________| NERVOUS SYSTEM | | | | __________________________________________________________________________| Brain | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Spinal Cord | | Hemorrhage | | _____________________________________________________________________________________________________________________| RESPIRATORY SYSTEM | | | | __________________________________________________________________________| Lung | + + + + + + + + + + + + + + + + + + + + + + + + +| Hemorrhage | 2 | Alveolar Epithelium, Hyperplasia | | __________________________________________________________________________| Nose | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Trachea | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| SPECIAL SENSES SYSTEM | | | | __________________________________________________________________________| Harderian Gland | + | _____________________________________________________________________________________________________________________| URINARY SYSTEM | | | | __________________________________________________________________________| Kidney | + + + + + + + + + + + + + + + + + + + + + + + + +| Glomerulosclerosis | 3 | Nephropathy | 3 | __________________________________________________________________________| Urinary Bladder | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| Page 34 NTP Experiment-Test: 05108-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:51:25 __________________________________________________________________________________________________________________________________ | 7| 7| 7| 7| 7| 5| 7| 7| 5| 7| | | DAY ON TEST | 3| 3| 3| 3| 3| 6| 3| 3| 1| 3| | | | 7| 7| 7| 8| 7| 1| 7| 7| 7| 7| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | B6C3F1 MICE FEMALE | 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| | T | ANIMAL ID | 8| 8| 8| 8| 9| 9| 9| 9| 9| 9| | A | 15.0 | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| | L | MG/KG | 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| | | __________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM | | | | | | __________________________________________________________________________|____________| Esophagus | + + + + + + + + + + | 59 | __________________________________________________________________________|____________| Gallbladder | + + + + + + + + + + | 57 | __________________________________________________________________________|____________| Intestine Large, Colon | + + + + + + + + + + | 60 | Artery, Inflammation, Acute | | 1 2.0| __________________________________________________________________________|____________| Intestine Large, Rectum | + + + + + + + + + + | 58 | __________________________________________________________________________|____________| Intestine Large, Cecum | + + + + + A + + + + | 58 | Hyperplasia | | 1 1.0| Epithelium, Hyperplasia | | 2 1.0| __________________________________________________________________________|____________| Intestine Small, Duodenum | + + + + + + + + + + | 59 | __________________________________________________________________________|____________| Intestine Small, Jejunum | + + + + + A + + + + | 57 | __________________________________________________________________________|____________| Intestine Small, Ileum | + + + + + A + + + + | 58 | __________________________________________________________________________|____________| Liver | + + + + + + + + + + | 60 | Basophilic Focus | | 3 | Eosinophilic Focus | | 3 | Hematopoietic Cell Proliferation | | 1 2.0| Mixed Cell Focus | | 3 | Necrosis, Focal | | 1 1.0| Necrosis | 1 | 1 1.0| Vacuolization Cytoplasmic, Focal | | 1 2.0| Sinusoid, Centrilobular, Ectasia | | 1 2.0| __________________________________________________________________________|____________| Mesentery | + | 2 | Fat, Necrosis | | 1 2.0| __________________________________________________________________________|____________| Pancreas | + + + + + + + + + + | 59 | __________________________________________________________________________|____________| Salivary Glands | + + M + + + + + + + | 59 | __________________________________________________________________________|____________| Stomach, Forestomach | + + + + + + + + + + | 60 | Acanthosis | | 1 2.0| Hyperkeratosis | | 3 1.7| Hyperplasia, Basal Cell | | 1 2.0| Hyperplasia, Squamous | | 1 1.0| __________________________________________________________________________|____________| Stomach, Glandular | + + + + + + + + + + | 59 | Hyperplasia | | 1 1.0| Necrosis | | 1 1.0| Artery, Inflammation, Acute | | 1 2.0| _____________________________________________________________________________________________________________________| | CARDIOVASCULAR SYSTEM | | | | | | __________________________________________________________________________|____________| Heart | + + + + + + + + + + | 60 | Mineralization | | 3 1.7| Artery, Inflammation, Acute | | 1 2.0| _____________________________________________________________________________________________________________________| | ENDOCRINE SYSTEM | | | __________________________________________________________________________________________________________________________________ * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 35 NTP Experiment-Test: 05108-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:51:25 __________________________________________________________________________________________________________________________________ | 7| 7| 7| 7| 7| 5| 7| 7| 5| 7| | | DAY ON TEST | 3| 3| 3| 3| 3| 6| 3| 3| 1| 3| | | | 7| 7| 7| 8| 7| 1| 7| 7| 7| 7| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | B6C3F1 MICE FEMALE | 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| | T | ANIMAL ID | 8| 8| 8| 8| 9| 9| 9| 9| 9| 9| | A | 15.0 | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| | L | MG/KG | 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| | | __________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM - cont | | | | | | | | | __________________________________________________________________________|____________| Adrenal Cortex | + + + + + + + + + + | 60 | __________________________________________________________________________|____________| Adrenal Medulla | + + + + + + + + + + | 59 | __________________________________________________________________________|____________| Islets, Pancreatic | + + + + + + + + + + | 59 | Hyperplasia | 2 | 1 2.0| __________________________________________________________________________|____________| Parathyroid Gland | + + M + + M + + M + | 44 | __________________________________________________________________________|____________| Pituitary Gland | + M M + + + + + + + | 58 | Pars Distalis, Angiectasis | | 6 2.0| Pars Distalis, Cyst | | 1 | Pars Distalis, Hyperplasia | 2 2 | 11 1.8| __________________________________________________________________________|____________| Thyroid Gland | + + + + + + + + + + | 60 | Follicle, Cyst | | 1 | Follicular Cell, Hyperplasia | 1 1 | 4 1.3| _____________________________________________________________________________________________________________________| | GENERAL BODY SYSTEM | | | | | | None | | | _____________________________________________________________________________________________________________________| | GENITAL SYSTEM | | | | | | __________________________________________________________________________|____________| Clitoral Gland | + | 3 | Dilatation | 2 | 3 2.0| __________________________________________________________________________|____________| Ovary | + + + + + + + + M + | 58 | Amyloid Deposition | | 1 2.0| Angiectasis | 3 | 1 3.0| Cyst | X X X | 12 | __________________________________________________________________________|____________| Uterus | + + + + + + + + + + | 60 | Angiectasis | | 1 2.0| Hyperplasia | | 1 3.0| Mineralization | | 1 2.0| Pigmentation | | 1 2.0| Thrombosis | | 1 2.0| Endometrium, Hyperplasia | | 7 2.4| _____________________________________________________________________________________________________________________| | HEMATOPOIETIC SYSTEM | | | | | | __________________________________________________________________________|____________| Blood | | 1 | __________________________________________________________________________|____________| Bone Marrow | + + + + + + + + + + | 59 | Angiectasis | | 1 2.0| __________________________________________________________________________|____________| Lymph Node | | 2 | __________________________________________________________________________|____________| Lymph Node, Mandibular | + + M + + + + + + + | 57 | __________________________________________________________________________|____________| Lymph Node, Mesenteric | + + + + + + + + + + | 54 | __________________________________________________________________________________________________________________________________ * : 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 36 NTP Experiment-Test: 05108-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:51:25 __________________________________________________________________________________________________________________________________ | 7| 7| 7| 7| 7| 5| 7| 7| 5| 7| | | DAY ON TEST | 3| 3| 3| 3| 3| 6| 3| 3| 1| 3| | | | 7| 7| 7| 8| 7| 1| 7| 7| 7| 7| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | B6C3F1 MICE FEMALE | 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| | T | ANIMAL ID | 8| 8| 8| 8| 9| 9| 9| 9| 9| 9| | A | 15.0 | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| | L | MG/KG | 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| | | __________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - cont | | | | | | Artery, Inflammation, Acute | | 1 2.0| __________________________________________________________________________|____________| Spleen | + + + + + + + + + + | 60 | Hematopoietic Cell Proliferation | 3 | 6 3.0| __________________________________________________________________________|____________| Thymus | + + + + + M + + + + | 57 | Hyperplasia | | 1 2.0| _____________________________________________________________________________________________________________________| | INTEGUMENTARY SYSTEM | | | | | | __________________________________________________________________________|____________| Mammary Gland | + + M M M + + + + + | 51 | __________________________________________________________________________|____________| Skin | + + + + + + + + + + | 59 | Necrosis | 2 | 1 2.0| _____________________________________________________________________________________________________________________| | MUSCULOSKELETAL SYSTEM | | | | | | __________________________________________________________________________|____________| Bone | + + + + + + + + + + | 60 | Fracture | | 1 2.0| _____________________________________________________________________________________________________________________| | NERVOUS SYSTEM | | | | | | __________________________________________________________________________|____________| Brain | + + + + + + + + + + | 60 | __________________________________________________________________________|____________| Spinal Cord | | 1 | Hemorrhage | | 1 2.0| _____________________________________________________________________________________________________________________| | RESPIRATORY SYSTEM | | | | | | __________________________________________________________________________|____________| Lung | + + + + + + + + + + | 60 | Hemorrhage | | 1 2.0| Alveolar Epithelium, Hyperplasia | 2 | 1 2.0| __________________________________________________________________________|____________| Nose | + + + + + + + + + + | 56 | __________________________________________________________________________|____________| Trachea | + + + + + + + + + + | 60 | _____________________________________________________________________________________________________________________| | SPECIAL SENSES SYSTEM | | | | | | __________________________________________________________________________|____________| Harderian Gland | | 1 | _____________________________________________________________________________________________________________________| | URINARY SYSTEM | | | | | | __________________________________________________________________________|____________| Kidney | + + + + + + + + + + | 60 | Glomerulosclerosis | | 1 3.0| Nephropathy | 1 | 2 2.0| __________________________________________________________________________|____________| Urinary Bladder | + + + + + + + + + + | 58 | __________________________________________________________________________________________________________________________________ * : 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 37 NTP Experiment-Test: 05108-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:51:25 _____________________________________________________________________________________________________________________ | 4| 7| 7| 7| 7| 5| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 5| 7| 4| 7| DAY ON TEST | 5| 3| 3| 3| 3| 1| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 8| 3| 5| 3| | 8| 3| 3| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 4| 6| 8| 6| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| B6C3F1 MICE MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 0| 0| 0| 0| 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 2| VEHICLE | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| MALE | 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| _____________________________________________________________________________________________________________________| ALIMENTARY SYSTEM | | | | __________________________________________________________________________| Esophagus | + + + + + + + + + + + + + + + + + + + + + + + + +| Hyperkeratosis | | __________________________________________________________________________| Gallbladder | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Large, Colon | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Large, Rectum | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Large, Cecum | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Small, Duodenum | + + + + + + + + + + + M + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Small, Jejunum | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Small, Ileum | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Liver | + + + + + + + + + + + + + + + + + + + + + + + + +| Basophilic Focus | X | Clear Cell Focus | | Eosinophilic Focus | | Fatty Change, Focal | | Inflammation, Focal, Necrotizing | | Inflammation, Granulomatous | | Mixed Cell Focus | X | Necrosis | | __________________________________________________________________________| Mesentery | + | Fat, Necrosis | 4 | __________________________________________________________________________| Pancreas | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Salivary Glands | + + + + + + + + + + + + + + + + + M + + M + + + +| __________________________________________________________________________| Stomach, Forestomach | + + + + + + + + + + + + + + + + + + + + + + + + +| Hyperkeratosis | 2| Hyperplasia, Basal Cell | 2 1| Inflammation, Chronic Active | 2 | Necrosis | 2| __________________________________________________________________________| Stomach, Glandular | + + + + + + + + + + + + + + + + + + + + + + + + +| Mineralization | | __________________________________________________________________________| Tongue | + | Mineralization | 2 | __________________________________________________________________________| Tooth | | Developmental Malformation | | _____________________________________________________________________________________________________________________| CARDIOVASCULAR SYSTEM | | | | __________________________________________________________________________| Heart | + + + + + + + + + + + + + + + + + + + + + + + + +| Cardiomyopathy | | Artery, Inflammation, Chronic Active | 1 | _____________________________________________________________________________________________________________________| ENDOCRINE SYSTEM | | | | __________________________________________________________________________| Adrenal Cortex | + + M + + + + + + + + + + + + + + M + + + + + + +| Accessory Adrenal Cortical Nodule | X | Hypertrophy | 1 | __________________________________________________________________________| Adrenal Medulla | + + M + + + + + + + + M + + + + + M + + + + + + +| _____________________________________________________________________________________________________________________| Page 38 NTP Experiment-Test: 05108-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:51:25 _____________________________________________________________________________________________________________________ | 4| 7| 7| 7| 7| 5| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 5| 7| 4| 7| DAY ON TEST | 5| 3| 3| 3| 3| 1| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 8| 3| 5| 3| | 8| 3| 3| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 4| 6| 8| 6| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| B6C3F1 MICE MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 0| 0| 0| 0| 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 2| VEHICLE | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| MALE | 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| _____________________________________________________________________________________________________________________| ENDOCRINE SYSTEM - cont | | | | __________________________________________________________________________| Islets, Pancreatic | + + + + + + + + + + + + + + + + + + + + + + + + +| Hyperplasia | | __________________________________________________________________________| Parathyroid Gland | M + + + + + M + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Pituitary Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| Pars Distalis, Hyperplasia | | __________________________________________________________________________| Thyroid Gland | + + + + + M + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| GENERAL BODY SYSTEM | | | | None | | _____________________________________________________________________________________________________________________| GENITAL SYSTEM | | | | __________________________________________________________________________| Epididymis | + + + + + + + + + + + + + + + + + + + + + + + + +| Granuloma Sperm | | Mineralization | | __________________________________________________________________________| Preputial Gland | + + + + + + + + + + + + | Dilatation | 2 2 2 2 2 2 | __________________________________________________________________________| Prostate | + + + + + + + + + + + + + + + + + M + + + + + + +| __________________________________________________________________________| Seminal Vesicle | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Testes | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| HEMATOPOIETIC SYSTEM | | | | __________________________________________________________________________| Blood | + | __________________________________________________________________________| Bone Marrow | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Lymph Node | + | __________________________________________________________________________| Lymph Node, Mandibular | + + + M M + + + + + + + + + + + + M + + M + + + +| __________________________________________________________________________| Lymph Node, Mesenteric | + + + + + + M + + + + M + + + + + + + + + + + + +| Hyperplasia, Lymphoid | 2 | __________________________________________________________________________| Spleen | + + + + + + + + + + + + + + + + + + + + + + + + +| Hematopoietic Cell Proliferation | 3 | __________________________________________________________________________| Thymus | + + + + + + + + M + M + + + + + + + + M M M + + +| Depletion Lymphoid | | _____________________________________________________________________________________________________________________| INTEGUMENTARY SYSTEM | | | | __________________________________________________________________________| Mammary Gland | M M M M M M M M M M M M M M M M M M M M M M M M M| __________________________________________________________________________| Skin | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| MUSCULOSKELETAL SYSTEM | | | | __________________________________________________________________________| Bone | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Skeletal Muscle | + | Artery, Inflammation, Chronic Active | 1 | _____________________________________________________________________________________________________________________| NERVOUS SYSTEM | | | | __________________________________________________________________________| Brain | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| RESPIRATORY SYSTEM | | _____________________________________________________________________________________________________________________| Page 39 NTP Experiment-Test: 05108-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:51:25 _____________________________________________________________________________________________________________________ | 4| 7| 7| 7| 7| 5| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 5| 7| 4| 7| DAY ON TEST | 5| 3| 3| 3| 3| 1| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 8| 3| 5| 3| | 8| 3| 3| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 4| 6| 8| 6| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| B6C3F1 MICE MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 0| 0| 0| 0| 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 2| VEHICLE | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| MALE | 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| _____________________________________________________________________________________________________________________| RESPIRATORY SYSTEM - cont | | | | | | __________________________________________________________________________| Lung | + + + + + + + + + + + + + + + + + + + + + + + + +| Edema | 2 | Hemorrhage | 2 | Infiltration Cellular, Histiocyte | 3 | Alveolar Epithelium, Hyperplasia | | __________________________________________________________________________| Nose | + + + + + + + + + + + + + + + + + + + + M + + + +| Inflammation, Acute | 2 | __________________________________________________________________________| Trachea | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| SPECIAL SENSES SYSTEM | | | | __________________________________________________________________________| Eye | + | Lens, Cataract | 2 | __________________________________________________________________________| Harderian Gland | | _____________________________________________________________________________________________________________________| URINARY SYSTEM | | | | __________________________________________________________________________| Kidney | + + + + + + + + + + + + + + + + + + + + + + + + +| Cyst | | Nephropathy | 2 2 1 1 2 | Renal Tubule, Regeneration | 1 | __________________________________________________________________________| Urinary Bladder | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| Page 40 NTP Experiment-Test: 05108-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:51:25 _____________________________________________________________________________________________________________________ | 4| 4| 6| 7| 4| 7| 7| 5| 7| 7| 4| 7| 4| 7| 7| 6| 2| 7| 7| 7| 7| 7| 7| 7| 4| DAY ON TEST | 6| 6| 7| 3| 6| 3| 3| 8| 3| 3| 5| 3| 5| 3| 3| 2| 8| 3| 3| 3| 3| 3| 3| 3| 5| | 0| 0| 4| 6| 0| 6| 6| 0| 6| 6| 8| 6| 8| 7| 7| 7| 3| 7| 7| 7| 7| 7| 7| 7| 8| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| B6C3F1 MICE 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| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 5| VEHICLE | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| MALE | 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| _____________________________________________________________________________________________________________________| ALIMENTARY SYSTEM | | | | __________________________________________________________________________| Esophagus | + + + + + + + + + + + + + + + + + + + + + + + + +| Hyperkeratosis | 2 | __________________________________________________________________________| Gallbladder | + + + + + + + + + + + + + + + + + + + + + + + + M| __________________________________________________________________________| Intestine Large, Colon | + + + + + + + + + + + + + + + A + + + + + + + + +| __________________________________________________________________________| Intestine Large, Rectum | + + + + + + + + + + + + + + + A + + + + + + + + +| __________________________________________________________________________| Intestine Large, Cecum | + + + + + + + + + + + + + + + A + + + + + + + + +| __________________________________________________________________________| Intestine Small, Duodenum | + + + + + + + M + + + + + + + A + + + + + + + + +| __________________________________________________________________________| Intestine Small, Jejunum | + + + + + + + + + + + + + + + A + + + + + + + + +| __________________________________________________________________________| Intestine Small, Ileum | + + + + + + + + + + + + + + + A + + + + + + + + +| __________________________________________________________________________| Liver | + + + + + + + + + + + + + + + + + + + + + + + + +| Basophilic Focus | | Clear Cell Focus | X | Eosinophilic Focus | X X X | Fatty Change, Focal | 1 1 2| Inflammation, Focal, Necrotizing | | Inflammation, Granulomatous | 2 | Mixed Cell Focus | X| Necrosis | 3 | __________________________________________________________________________| Mesentery | | Fat, Necrosis | | __________________________________________________________________________| Pancreas | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Salivary Glands | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Stomach, Forestomach | + + + + + + + + + + + + + + + + + + + + + + + + +| Hyperkeratosis | 1 | Hyperplasia, Basal Cell | 2 | Inflammation, Chronic Active | 1 | Necrosis | | __________________________________________________________________________| Stomach, Glandular | + + + + + + + + + + + + + + + + + + + + + + + + +| Mineralization | | __________________________________________________________________________| Tongue | | Mineralization | | __________________________________________________________________________| Tooth | + | Developmental Malformation | X | _____________________________________________________________________________________________________________________| CARDIOVASCULAR SYSTEM | | | | __________________________________________________________________________| Heart | + + + + + + + + + + + + + + + + + + + + + + + + +| Cardiomyopathy | 2 | Artery, Inflammation, Chronic Active | | _____________________________________________________________________________________________________________________| ENDOCRINE SYSTEM | | | | __________________________________________________________________________| Adrenal Cortex | + + + + + + + + + + + + + + + + + + + + + + + + +| Accessory Adrenal Cortical Nodule | X | Hypertrophy | 1 1 | __________________________________________________________________________| Adrenal Medulla | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| Page 41 NTP Experiment-Test: 05108-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:51:25 _____________________________________________________________________________________________________________________ | 4| 4| 6| 7| 4| 7| 7| 5| 7| 7| 4| 7| 4| 7| 7| 6| 2| 7| 7| 7| 7| 7| 7| 7| 4| DAY ON TEST | 6| 6| 7| 3| 6| 3| 3| 8| 3| 3| 5| 3| 5| 3| 3| 2| 8| 3| 3| 3| 3| 3| 3| 3| 5| | 0| 0| 4| 6| 0| 6| 6| 0| 6| 6| 8| 6| 8| 7| 7| 7| 3| 7| 7| 7| 7| 7| 7| 7| 8| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| B6C3F1 MICE 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| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 5| VEHICLE | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| MALE | 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| _____________________________________________________________________________________________________________________| ENDOCRINE SYSTEM - cont | | | | __________________________________________________________________________| Islets, Pancreatic | + + + + + + + + + + + + + + + + + + + + + + + + +| Hyperplasia | 2 2 1 | __________________________________________________________________________| Parathyroid Gland | + + + + M + M + + + + + + + + + + + + + + + M + M| __________________________________________________________________________| Pituitary Gland | + + + + + + + + + + + + + + + M + + + + + M + + +| Pars Distalis, Hyperplasia | 2 | __________________________________________________________________________| Thyroid Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| GENERAL BODY SYSTEM | | | | None | | _____________________________________________________________________________________________________________________| GENITAL SYSTEM | | | | __________________________________________________________________________| Epididymis | + + + + + + + + + + + + + + + + + + + + + + + + +| Granuloma Sperm | 3 | Mineralization | 2 | __________________________________________________________________________| Preputial Gland | + M + + + | Dilatation | 2 2 | __________________________________________________________________________| Prostate | + + + + + + M M M + + + + + + + + + + + + + + + +| __________________________________________________________________________| Seminal Vesicle | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Testes | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| HEMATOPOIETIC SYSTEM | | | | __________________________________________________________________________| Blood | | __________________________________________________________________________| Bone Marrow | + + + + + + + M + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Lymph Node | | __________________________________________________________________________| Lymph Node, Mandibular | + + + + + + + + + + + M + + + + + + + + + + + + M| __________________________________________________________________________| Lymph Node, Mesenteric | + + + + + + + + + + + + + + + + + + M + + M + + +| Hyperplasia, Lymphoid | | __________________________________________________________________________| Spleen | + + + + + + + + + + + + + + + + + + + + + + + + +| Hematopoietic Cell Proliferation | 2 | __________________________________________________________________________| Thymus | + + + + + + + + + + + M M M M + + + M + M + M M +| Depletion Lymphoid | 2 | _____________________________________________________________________________________________________________________| INTEGUMENTARY SYSTEM | | | | __________________________________________________________________________| Mammary Gland | M M M M M M M M M M M M M M M M M M M M M M M M M| __________________________________________________________________________| Skin | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| MUSCULOSKELETAL SYSTEM | | | | __________________________________________________________________________| Bone | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Skeletal Muscle | | Artery, Inflammation, Chronic Active | | _____________________________________________________________________________________________________________________| NERVOUS SYSTEM | | | | __________________________________________________________________________| Brain | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| RESPIRATORY SYSTEM | | _____________________________________________________________________________________________________________________| Page 42 NTP Experiment-Test: 05108-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:51:25 _____________________________________________________________________________________________________________________ | 4| 4| 6| 7| 4| 7| 7| 5| 7| 7| 4| 7| 4| 7| 7| 6| 2| 7| 7| 7| 7| 7| 7| 7| 4| DAY ON TEST | 6| 6| 7| 3| 6| 3| 3| 8| 3| 3| 5| 3| 5| 3| 3| 2| 8| 3| 3| 3| 3| 3| 3| 3| 5| | 0| 0| 4| 6| 0| 6| 6| 0| 6| 6| 8| 6| 8| 7| 7| 7| 3| 7| 7| 7| 7| 7| 7| 7| 8| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| B6C3F1 MICE 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| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 5| VEHICLE | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| MALE | 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| _____________________________________________________________________________________________________________________| RESPIRATORY SYSTEM - cont | | | | | | __________________________________________________________________________| Lung | + + + + + + + + + + + + + + + + + + + + + + + + +| Edema | | Hemorrhage | | Infiltration Cellular, Histiocyte | 2 2 3 2 | Alveolar Epithelium, Hyperplasia | | __________________________________________________________________________| Nose | + + + + + + + + + + + + + + + + + + + + + + + + +| Inflammation, Acute | | __________________________________________________________________________| Trachea | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| SPECIAL SENSES SYSTEM | | | | __________________________________________________________________________| Eye | + | Lens, Cataract | | __________________________________________________________________________| Harderian Gland | | _____________________________________________________________________________________________________________________| URINARY SYSTEM | | | | __________________________________________________________________________| Kidney | + + + + + + + + + + + + + + + + + + + + + + + + +| Cyst | | Nephropathy | 1 1 | Renal Tubule, Regeneration | 2 1 1 1| __________________________________________________________________________| Urinary Bladder | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| Page 43 NTP Experiment-Test: 05108-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:51:25 __________________________________________________________________________________________________________________________________ | 7| 4| 6| 6| 3| 4| 7| 7| 7| 6| | | DAY ON TEST | 2| 6| 3| 9| 6| 5| 3| 3| 3| 7| | | | 2| 0| 3| 8| 2| 8| 6| 6| 7| 6| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | B6C3F1 MICE MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 5| 5| 5| 5| 5| 5| 5| 5| 5| 6| | A | VEHICLE | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| | L | MALE | 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| | | __________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM | | | | | | __________________________________________________________________________|____________| Esophagus | + + + + + + + + + + | 60 | Hyperkeratosis | | 1 2.0| __________________________________________________________________________|____________| Gallbladder | + + M + A + + + + + | 57 | __________________________________________________________________________|____________| Intestine Large, Colon | + + + + + + + + + + | 59 | __________________________________________________________________________|____________| Intestine Large, Rectum | + + A + + + + + + + | 58 | __________________________________________________________________________|____________| Intestine Large, Cecum | + + + + + + + + + + | 59 | __________________________________________________________________________|____________| Intestine Small, Duodenum | + + M + M + + + + + | 55 | __________________________________________________________________________|____________| Intestine Small, Jejunum | + + + + M + + + + + | 58 | __________________________________________________________________________|____________| Intestine Small, Ileum | + + + + + + + + + + | 59 | __________________________________________________________________________|____________| Liver | + + + + + + + + + + | 60 | Basophilic Focus | | 1 | Clear Cell Focus | | 1 | Eosinophilic Focus | | 3 | Fatty Change, Focal | 2 | 4 1.5| Inflammation, Focal, Necrotizing | 1 | 1 1.0| Inflammation, Granulomatous | | 1 2.0| Mixed Cell Focus | X | 3 | Necrosis | 1 | 2 2.0| __________________________________________________________________________|____________| Mesentery | | 1 | Fat, Necrosis | | 1 4.0| __________________________________________________________________________|____________| Pancreas | + + + + + + + + + + | 60 | __________________________________________________________________________|____________| Salivary Glands | + + + + + + + + + + | 58 | __________________________________________________________________________|____________| Stomach, Forestomach | + + + + + + + + + + | 60 | Hyperkeratosis | | 2 1.5| Hyperplasia, Basal Cell | | 3 1.7| Inflammation, Chronic Active | | 2 1.5| Necrosis | | 1 2.0| __________________________________________________________________________|____________| Stomach, Glandular | + + + + + + + + + + | 60 | Mineralization | 2 | 1 2.0| __________________________________________________________________________|____________| Tongue | | 1 | Mineralization | | 1 2.0| __________________________________________________________________________|____________| Tooth | | 1 | Developmental Malformation | | 1 | _____________________________________________________________________________________________________________________| | CARDIOVASCULAR SYSTEM | | | | | | __________________________________________________________________________|____________| Heart | + + + + + + + + + + | 60 | Cardiomyopathy | | 1 2.0| Artery, Inflammation, Chronic Active | | 1 1.0| _____________________________________________________________________________________________________________________| | ENDOCRINE SYSTEM | | | __________________________________________________________________________________________________________________________________ * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 44 NTP Experiment-Test: 05108-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:51:25 __________________________________________________________________________________________________________________________________ | 7| 4| 6| 6| 3| 4| 7| 7| 7| 6| | | DAY ON TEST | 2| 6| 3| 9| 6| 5| 3| 3| 3| 7| | | | 2| 0| 3| 8| 2| 8| 6| 6| 7| 6| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | B6C3F1 MICE MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 5| 5| 5| 5| 5| 5| 5| 5| 5| 6| | A | VEHICLE | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| | L | MALE | 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| | | __________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM - cont | | | | | | | | | __________________________________________________________________________|____________| Adrenal Cortex | + + + + + + + + + + | 58 | Accessory Adrenal Cortical Nodule | | 2 | Hypertrophy | | 3 1.0| __________________________________________________________________________|____________| Adrenal Medulla | + + + + M + + + + + | 56 | __________________________________________________________________________|____________| Islets, Pancreatic | + + + + + + + + + + | 60 | Hyperplasia | 3 | 4 2.0| __________________________________________________________________________|____________| Parathyroid Gland | M M + M + + + M M + | 49 | __________________________________________________________________________|____________| Pituitary Gland | + + + + + + + + + + | 58 | Pars Distalis, Hyperplasia | | 1 2.0| __________________________________________________________________________|____________| Thyroid Gland | + + + + + + + + + + | 58 | _____________________________________________________________________________________________________________________| | GENERAL BODY SYSTEM | | | | | | None | | | _____________________________________________________________________________________________________________________| | GENITAL SYSTEM | | | | | | __________________________________________________________________________|____________| Epididymis | + + + + + + + + + + | 60 | Granuloma Sperm | | 1 3.0| Mineralization | | 1 2.0| __________________________________________________________________________|____________| Preputial Gland | + | 17 | Dilatation | | 8 2.0| __________________________________________________________________________|____________| Prostate | + + + + M + + + + + | 55 | __________________________________________________________________________|____________| Seminal Vesicle | + + + + + + + + + + | 60 | __________________________________________________________________________|____________| Testes | + + + + + + + + + + | 60 | _____________________________________________________________________________________________________________________| | HEMATOPOIETIC SYSTEM | | | | | | __________________________________________________________________________|____________| Blood | | 1 | __________________________________________________________________________|____________| Bone Marrow | + + + + + + + + + + | 59 | __________________________________________________________________________|____________| Lymph Node | | 1 | __________________________________________________________________________|____________| Lymph Node, Mandibular | + + + + + + M + + + | 53 | __________________________________________________________________________|____________| Lymph Node, Mesenteric | + + + M + + + M + M | 53 | Hyperplasia, Lymphoid | | 1 2.0| __________________________________________________________________________|____________| Spleen | + + + + + + + M + + | 59 | Hematopoietic Cell Proliferation | | 2 2.5| __________________________________________________________________________|____________| Thymus | + + + + + + + + + + | 47 | Depletion Lymphoid | | 1 2.0| _____________________________________________________________________________________________________________________| | INTEGUMENTARY SYSTEM | | | | | | __________________________________________________________________________|____________| Mammary Gland | M M M M M M M M M M | | __________________________________________________________________________________________________________________________________ * : 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 45 NTP Experiment-Test: 05108-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:51:25 __________________________________________________________________________________________________________________________________ | 7| 4| 6| 6| 3| 4| 7| 7| 7| 6| | | DAY ON TEST | 2| 6| 3| 9| 6| 5| 3| 3| 3| 7| | | | 2| 0| 3| 8| 2| 8| 6| 6| 7| 6| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | B6C3F1 MICE MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 5| 5| 5| 5| 5| 5| 5| 5| 5| 6| | A | VEHICLE | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| | L | MALE | 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| | | __________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM - cont | | | | | | __________________________________________________________________________|____________| Skin | + + + + + + + + + + | 60 | _____________________________________________________________________________________________________________________| | MUSCULOSKELETAL SYSTEM | | | | | | __________________________________________________________________________|____________| Bone | + + + + + + + + + + | 60 | __________________________________________________________________________|____________| Skeletal Muscle | | 1 | Artery, Inflammation, Chronic Active | | 1 1.0| _____________________________________________________________________________________________________________________| | NERVOUS SYSTEM | | | | | | __________________________________________________________________________|____________| Brain | + + + + + + + + + + | 60 | _____________________________________________________________________________________________________________________| | RESPIRATORY SYSTEM | | | | | | __________________________________________________________________________|____________| Lung | + + + + + + + + + + | 60 | Edema | | 1 2.0| Hemorrhage | | 1 2.0| Infiltration Cellular, Histiocyte | 2 | 6 2.3| Alveolar Epithelium, Hyperplasia | 1 | 1 1.0| __________________________________________________________________________|____________| Nose | + + + + + + + + + + | 59 | Inflammation, Acute | | 1 2.0| __________________________________________________________________________|____________| Trachea | + + + + + + + + + + | 60 | _____________________________________________________________________________________________________________________| | SPECIAL SENSES SYSTEM | | | | | | __________________________________________________________________________|____________| Eye | | 2 | Lens, Cataract | | 1 2.0| __________________________________________________________________________|____________| Harderian Gland | + | 1 | _____________________________________________________________________________________________________________________| | URINARY SYSTEM | | | | | | __________________________________________________________________________|____________| Kidney | + + + + + + + + + + | 60 | Cyst | X | 1 | Nephropathy | | 7 1.4| Renal Tubule, Regeneration | 2 | 6 1.3| __________________________________________________________________________|____________| Urinary Bladder | + + + + + + + + + M | 59 | __________________________________________________________________________________________________________________________________ * : 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 46 NTP Experiment-Test: 05108-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:51:25 _____________________________________________________________________________________________________________________ | 4| 4| 7| 7| 7| 7| 7| 7| 7| 7| 4| 7| 7| 7| 4| 7| 7| 4| 7| 7| 7| 7| 7| 7| 7| DAY ON TEST | 5| 5| 3| 1| 3| 3| 3| 3| 3| 3| 6| 3| 3| 3| 5| 3| 3| 5| 3| 3| 3| 3| 3| 3| 3| | 8| 8| 1| 3| 1| 1| 1| 1| 1| 1| 0| 1| 6| 1| 8| 1| 1| 8| 1| 1| 1| 1| 2| 2| 1| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| B6C3F1 MICE MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 6| 6| 6| 6| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 8| 8| 8| 8| 8| 8| 11.25 | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| MG/KG | 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| _____________________________________________________________________________________________________________________| ALIMENTARY SYSTEM | | | | __________________________________________________________________________| Esophagus | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Gallbladder | + + + + + + + + + + + + M + + + + + + + + + + + +| __________________________________________________________________________| Intestine Large, Colon | + + + + M + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Large, Rectum | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Large, Cecum | + + + + + + + + + + + + + + + + + + + + + + + + +| Hyperplasia | | __________________________________________________________________________| Intestine Small, Duodenum | + + + + M + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Small, Jejunum | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Small, Ileum | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Liver | + + + + + + + + + + + + + + + + + + + + + + + + +| Basophilic Focus | X X | Clear Cell Focus | X | Eosinophilic Focus | X X X X | Fatty Change, Diffuse | | Fatty Change, Focal | 2 | Inflammation, Focal, Necrotizing | | Mixed Cell Focus | X | __________________________________________________________________________| Pancreas | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Salivary Glands | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Stomach, Forestomach | + + + + + + + + + + + + + + + + + + + + + + + + +| Hyperkeratosis | | Hyperplasia, Basal Cell | 2 | Inflammation, Chronic Active | 2 | __________________________________________________________________________| Stomach, Glandular | + + + + + + + + + + + + + + + + + + + + + + + + +| Hyperplasia | | Necrosis | | __________________________________________________________________________| Tongue | | _____________________________________________________________________________________________________________________| CARDIOVASCULAR SYSTEM | | | | __________________________________________________________________________| Heart | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| ENDOCRINE SYSTEM | | | | __________________________________________________________________________| Adrenal Cortex | + + + + + + + + + + + + + + + + + + + + + + + + +| Hypertrophy | 3 | __________________________________________________________________________| Adrenal Medulla | + + + + + + M M + + + + + + + + + + + M + + + + +| __________________________________________________________________________| Islets, Pancreatic | + + + + + + + + + + + + + + + + + + + + + + + + +| Hyperplasia | | __________________________________________________________________________| Parathyroid Gland | + + M M + M + + + + + + M M + + + + + + + + + + +| __________________________________________________________________________| Pituitary Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| Pars Distalis, Cyst | X | __________________________________________________________________________| Thyroid Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| GENERAL BODY SYSTEM | | | | None | | _____________________________________________________________________________________________________________________| Page 47 NTP Experiment-Test: 05108-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:51:25 _____________________________________________________________________________________________________________________ | 4| 4| 7| 7| 7| 7| 7| 7| 7| 7| 4| 7| 7| 7| 4| 7| 7| 4| 7| 7| 7| 7| 7| 7| 7| DAY ON TEST | 5| 5| 3| 1| 3| 3| 3| 3| 3| 3| 6| 3| 3| 3| 5| 3| 3| 5| 3| 3| 3| 3| 3| 3| 3| | 8| 8| 1| 3| 1| 1| 1| 1| 1| 1| 0| 1| 6| 1| 8| 1| 1| 8| 1| 1| 1| 1| 2| 2| 1| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| B6C3F1 MICE MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 6| 6| 6| 6| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 8| 8| 8| 8| 8| 8| 11.25 | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| MG/KG | 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| _____________________________________________________________________________________________________________________| GENITAL SYSTEM | | | | __________________________________________________________________________| Epididymis | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Preputial Gland | + + + + + + + + | Abscess | 3 | Dilatation | 2 2 2 3 2 2 2 | __________________________________________________________________________| Prostate | + + + + + + + + + + + + + M + + + + + M + + + + +| Hyperplasia | | __________________________________________________________________________| Seminal Vesicle | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Testes | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| HEMATOPOIETIC SYSTEM | | | | __________________________________________________________________________| Bone Marrow | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Lymph Node | | __________________________________________________________________________| Lymph Node, Mandibular | + + + + + + + + + M M + + + + + + M + + M + + + +| Hematopoietic Cell Proliferation | | __________________________________________________________________________| Lymph Node, Mesenteric | + + + + + + + + + + + + + + + M + + + + + + + + +| Thrombosis | 2 | __________________________________________________________________________| Spleen | + + + + + + + + + + + + + M + + + + + + + + + + +| Angiectasis | 1| Hematopoietic Cell Proliferation | 3 2 2 3 1| Hyperplasia | | __________________________________________________________________________| Thymus | + + + M + + + + + M + + + + + M M M M + + + + + +| _____________________________________________________________________________________________________________________| INTEGUMENTARY SYSTEM | | | | __________________________________________________________________________| Mammary Gland | M M M M M M M M M M M M M M M M + M M M M M M M M| __________________________________________________________________________| Skin | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| MUSCULOSKELETAL SYSTEM | | | | __________________________________________________________________________| Bone | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Skeletal Muscle | | _____________________________________________________________________________________________________________________| NERVOUS SYSTEM | | | | __________________________________________________________________________| Brain | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| RESPIRATORY SYSTEM | | | | __________________________________________________________________________| Lung | + + + + + + + + + + + + + + + + + + + + + + + + +| Hemorrhage | 2 | Infiltration Cellular, Histiocyte | 1 | Alveolar Epithelium, Hyperplasia | 3 | __________________________________________________________________________| Nose | + + + + + + + + + + + + + + + M + + M + + + + + +| __________________________________________________________________________| Trachea | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| SPECIAL SENSES SYSTEM | | | | __________________________________________________________________________| Eye | + | Cornea, Inflammation, Acute | | _____________________________________________________________________________________________________________________| Page 48 NTP Experiment-Test: 05108-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:51:25 _____________________________________________________________________________________________________________________ | 4| 4| 7| 7| 7| 7| 7| 7| 7| 7| 4| 7| 7| 7| 4| 7| 7| 4| 7| 7| 7| 7| 7| 7| 7| DAY ON TEST | 5| 5| 3| 1| 3| 3| 3| 3| 3| 3| 6| 3| 3| 3| 5| 3| 3| 5| 3| 3| 3| 3| 3| 3| 3| | 8| 8| 1| 3| 1| 1| 1| 1| 1| 1| 0| 1| 6| 1| 8| 1| 1| 8| 1| 1| 1| 1| 2| 2| 1| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| B6C3F1 MICE MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 6| 6| 6| 6| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 8| 8| 8| 8| 8| 8| 11.25 | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| MG/KG | 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| _____________________________________________________________________________________________________________________| SPECIAL SENSES SYSTEM - cont | | | | __________________________________________________________________________| Harderian Gland | + | _____________________________________________________________________________________________________________________| URINARY SYSTEM | | | | __________________________________________________________________________| Kidney | + + + + + + + + + + + + + + + + + + + + + + + + +| Cyst | X X | Infiltration Cellular, Plasma Cell | | Nephropathy | 1 1 1 1 2 | Renal Tubule, Regeneration | | __________________________________________________________________________| Urinary Bladder | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| Page 49 NTP Experiment-Test: 05108-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:51:25 _____________________________________________________________________________________________________________________ | 4| 7| 7| 7| 7| 7| 6| 7| 7| 7| 6| 7| 7| 5| 7| 4| 7| 7| 7| 7| 4| 7| 7| 7| 7| DAY ON TEST | 6| 3| 3| 3| 3| 3| 0| 3| 3| 3| 4| 3| 3| 6| 3| 5| 3| 3| 3| 3| 6| 3| 3| 3| 3| | 0| 1| 1| 6| 6| 1| 0| 2| 2| 2| 9| 2| 2| 8| 2| 8| 2| 2| 2| 2| 0| 2| 2| 2| 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| B6C3F1 MICE MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| ANIMAL ID | 8| 8| 8| 8| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 1| 11.25 | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| MG/KG | 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| _____________________________________________________________________________________________________________________| ALIMENTARY SYSTEM | | | | __________________________________________________________________________| Esophagus | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Gallbladder | + + + + + + + + M + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Large, Colon | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Large, Rectum | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Large, Cecum | + + + + + + + + + + + + + + + + + + + + + + + + +| Hyperplasia | | __________________________________________________________________________| Intestine Small, Duodenum | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Small, Jejunum | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Small, Ileum | + + + + + + + + + + + + + + + + + + + + + + + + M| __________________________________________________________________________| Liver | + + + + + + + + + + + + + + + + + + + + + + + + +| Basophilic Focus | X X X X| Clear Cell Focus | X | Eosinophilic Focus | X X X X | Fatty Change, Diffuse | | Fatty Change, Focal | | Inflammation, Focal, Necrotizing | 1 | Mixed Cell Focus | X X X | __________________________________________________________________________| Pancreas | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Salivary Glands | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Stomach, Forestomach | + + + + + + + + + + + + + + + + + + + + + + + + +| Hyperkeratosis | 2 | Hyperplasia, Basal Cell | | Inflammation, Chronic Active | | __________________________________________________________________________| Stomach, Glandular | + + + + + + + + + + + + + + + + + + + + + + + + +| Hyperplasia | | Necrosis | X | __________________________________________________________________________| Tongue | + | _____________________________________________________________________________________________________________________| CARDIOVASCULAR SYSTEM | | | | __________________________________________________________________________| Heart | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| ENDOCRINE SYSTEM | | | | __________________________________________________________________________| Adrenal Cortex | + + + + + + + + + + + + + + + + + + + + + + + + +| Hypertrophy | 2 2 2 1 | __________________________________________________________________________| Adrenal Medulla | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Islets, Pancreatic | + + + + + + + + + + + + + + + + + + + + + + + + +| Hyperplasia | 2 | __________________________________________________________________________| Parathyroid Gland | M + + + + + + + M + + + + M M + M + M + M + + M +| __________________________________________________________________________| Pituitary Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| Pars Distalis, Cyst | | __________________________________________________________________________| Thyroid Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| GENERAL BODY SYSTEM | | | | None | | _____________________________________________________________________________________________________________________| Page 50 NTP Experiment-Test: 05108-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:51:25 _____________________________________________________________________________________________________________________ | 4| 7| 7| 7| 7| 7| 6| 7| 7| 7| 6| 7| 7| 5| 7| 4| 7| 7| 7| 7| 4| 7| 7| 7| 7| DAY ON TEST | 6| 3| 3| 3| 3| 3| 0| 3| 3| 3| 4| 3| 3| 6| 3| 5| 3| 3| 3| 3| 6| 3| 3| 3| 3| | 0| 1| 1| 6| 6| 1| 0| 2| 2| 2| 9| 2| 2| 8| 2| 8| 2| 2| 2| 2| 0| 2| 2| 2| 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| B6C3F1 MICE MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| ANIMAL ID | 8| 8| 8| 8| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 1| 11.25 | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| MG/KG | 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| _____________________________________________________________________________________________________________________| GENITAL SYSTEM | | | | __________________________________________________________________________| Epididymis | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Preputial Gland | + + + + + + + + + + +| Abscess | 3 | Dilatation | 2 2 2 2 2 2 2| __________________________________________________________________________| Prostate | + + + + + + + + + + + + + + + + + + + + + M + + +| Hyperplasia | 1 | __________________________________________________________________________| Seminal Vesicle | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Testes | + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| HEMATOPOIETIC SYSTEM | | | | __________________________________________________________________________| Bone Marrow | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Lymph Node | | __________________________________________________________________________| Lymph Node, Mandibular | + + + + + + + + + + + + + M + M + + + M + + M + +| Hematopoietic Cell Proliferation | 3 | __________________________________________________________________________| Lymph Node, Mesenteric | + + + + + + + + M + + + + + + M + + + + + + + + +| Thrombosis | | __________________________________________________________________________| Spleen | + + + + + + + + M + + + + + + + + + + + + + + + +| Angiectasis | 1 1 1 | Hematopoietic Cell Proliferation | 3 2 2 2 | Hyperplasia | 2 2 2 2 | __________________________________________________________________________| Thymus | + + + + + + M M M + + + + + + + + + + + + + + + M| _____________________________________________________________________________________________________________________| INTEGUMENTARY SYSTEM | | | | __________________________________________________________________________| Mammary Gland | M M M M M M M M M M M M M M M M M M M M M M M M M| __________________________________________________________________________| Skin | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| MUSCULOSKELETAL SYSTEM | | | | __________________________________________________________________________| Bone | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Skeletal Muscle | + | _____________________________________________________________________________________________________________________| NERVOUS SYSTEM | | | | __________________________________________________________________________| Brain | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| RESPIRATORY SYSTEM | | | | __________________________________________________________________________| Lung | + + + + + + + + + + + + + + + + + + + + + + + + +| Hemorrhage | 1 2 | Infiltration Cellular, Histiocyte | 2 3| Alveolar Epithelium, Hyperplasia | | __________________________________________________________________________| Nose | + + + + + + + + + M + + + + + + + + + + + + + + +| __________________________________________________________________________| Trachea | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| SPECIAL SENSES SYSTEM | | | | __________________________________________________________________________| Eye | + | Cornea, Inflammation, Acute | 3 | _____________________________________________________________________________________________________________________| Page 51 NTP Experiment-Test: 05108-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:51:25 _____________________________________________________________________________________________________________________ | 4| 7| 7| 7| 7| 7| 6| 7| 7| 7| 6| 7| 7| 5| 7| 4| 7| 7| 7| 7| 4| 7| 7| 7| 7| DAY ON TEST | 6| 3| 3| 3| 3| 3| 0| 3| 3| 3| 4| 3| 3| 6| 3| 5| 3| 3| 3| 3| 6| 3| 3| 3| 3| | 0| 1| 1| 6| 6| 1| 0| 2| 2| 2| 9| 2| 2| 8| 2| 8| 2| 2| 2| 2| 0| 2| 2| 2| 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| B6C3F1 MICE MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| ANIMAL ID | 8| 8| 8| 8| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 1| 11.25 | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| MG/KG | 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| _____________________________________________________________________________________________________________________| SPECIAL SENSES SYSTEM - cont | | | | __________________________________________________________________________| Harderian Gland | + | _____________________________________________________________________________________________________________________| URINARY SYSTEM | | | | __________________________________________________________________________| Kidney | + + + + + + + + + + + + + + + + + + + + + + + + +| Cyst | X X | Infiltration Cellular, Plasma Cell | | Nephropathy | 2 | Renal Tubule, Regeneration | | __________________________________________________________________________| Urinary Bladder | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| Page 52 NTP Experiment-Test: 05108-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:51:25 __________________________________________________________________________________________________________________________________ | 7| 7| 4| 7| 1| 7| 7| 4| 2| 7| | | DAY ON TEST | 3| 3| 5| 3| 2| 3| 3| 6| 1| 3| | | | 2| 3| 8| 3| 8| 3| 3| 0| 1| 3| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | B6C3F1 MICE MALE | 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| | T | ANIMAL ID | 1| 1| 1| 1| 1| 1| 1| 1| 1| 2| | A | 11.25 | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| | L | MG/KG | 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| | | __________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM | | | | | | __________________________________________________________________________|____________| Esophagus | + + + + + + + + + + | 60 | __________________________________________________________________________|____________| Gallbladder | + + + + + + + + + + | 58 | __________________________________________________________________________|____________| Intestine Large, Colon | + + + + + + + + + + | 59 | __________________________________________________________________________|____________| Intestine Large, Rectum | + + + + + + + + + + | 60 | __________________________________________________________________________|____________| Intestine Large, Cecum | + + + + + + + + + + | 60 | Hyperplasia | 1 | 1 1.0| __________________________________________________________________________|____________| Intestine Small, Duodenum | + + + + + + + + + + | 59 | __________________________________________________________________________|____________| Intestine Small, Jejunum | + + + + + + + + + + | 60 | __________________________________________________________________________|____________| Intestine Small, Ileum | + + + + + + + + + + | 59 | __________________________________________________________________________|____________| Liver | + + + + + + + + + + | 60 | Basophilic Focus | | 6 | Clear Cell Focus | | 2 | Eosinophilic Focus | X | 9 | Fatty Change, Diffuse | 2 | 1 2.0| Fatty Change, Focal | 1 | 2 1.5| Inflammation, Focal, Necrotizing | | 1 1.0| Mixed Cell Focus | X | 5 | __________________________________________________________________________|____________| Pancreas | + + + + + + + + + + | 60 | __________________________________________________________________________|____________| Salivary Glands | + + + + + + + + + + | 60 | __________________________________________________________________________|____________| Stomach, Forestomach | + + + + + + + + + + | 60 | Hyperkeratosis | | 1 2.0| Hyperplasia, Basal Cell | | 1 2.0| Inflammation, Chronic Active | | 1 2.0| __________________________________________________________________________|____________| Stomach, Glandular | + + + + + + + + + + | 60 | Hyperplasia | 1 | 1 1.0| Necrosis | | 1 | __________________________________________________________________________|____________| Tongue | + | 2 | _____________________________________________________________________________________________________________________| | CARDIOVASCULAR SYSTEM | | | | | | __________________________________________________________________________|____________| Heart | + + + + + + + + + + | 60 | _____________________________________________________________________________________________________________________| | ENDOCRINE SYSTEM | | | | | | __________________________________________________________________________|____________| Adrenal Cortex | + + + + + + + + + + | 60 | Hypertrophy | 2 | 6 2.0| __________________________________________________________________________|____________| Adrenal Medulla | + + + + + + M + + + | 56 | __________________________________________________________________________|____________| Islets, Pancreatic | + + + + + + + + + + | 60 | Hyperplasia | | 1 2.0| __________________________________________________________________________|____________| Parathyroid Gland | + M M + M + M M M + | 41 | __________________________________________________________________________|____________| Pituitary Gland | + + + + + + + + + + | 60 | __________________________________________________________________________________________________________________________________ * : 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: 05108-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:51:25 __________________________________________________________________________________________________________________________________ | 7| 7| 4| 7| 1| 7| 7| 4| 2| 7| | | DAY ON TEST | 3| 3| 5| 3| 2| 3| 3| 6| 1| 3| | | | 2| 3| 8| 3| 8| 3| 3| 0| 1| 3| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | B6C3F1 MICE MALE | 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| | T | ANIMAL ID | 1| 1| 1| 1| 1| 1| 1| 1| 1| 2| | A | 11.25 | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| | L | MG/KG | 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| | | __________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM - cont | | | | | | Pars Distalis, Cyst | | 1 | __________________________________________________________________________|____________| Thyroid Gland | + + + + + + + + + + | 60 | _____________________________________________________________________________________________________________________| | GENERAL BODY SYSTEM | | | | | | None | | | _____________________________________________________________________________________________________________________| | GENITAL SYSTEM | | | | | | __________________________________________________________________________|____________| Epididymis | + + + + + + + + + + | 60 | __________________________________________________________________________|____________| Preputial Gland | + + + + + | 24 | Abscess | | 2 3.0| Dilatation | 2 2 1 2 2 | 19 2.0| __________________________________________________________________________|____________| Prostate | + + + + + M + M + + | 55 | Hyperplasia | | 1 1.0| __________________________________________________________________________|____________| Seminal Vesicle | + + + + + + + + + + | 60 | __________________________________________________________________________|____________| Testes | + + + + + + + + + + | 59 | _____________________________________________________________________________________________________________________| | HEMATOPOIETIC SYSTEM | | | | | | __________________________________________________________________________|____________| Bone Marrow | + + + + + + + + + + | 60 | __________________________________________________________________________|____________| Lymph Node | + | 1 | __________________________________________________________________________|____________| Lymph Node, Mandibular | + + + + + + M + + + | 51 | Hematopoietic Cell Proliferation | | 1 3.0| __________________________________________________________________________|____________| Lymph Node, Mesenteric | + M + + + + + M + + | 55 | Thrombosis | | 1 2.0| __________________________________________________________________________|____________| Spleen | + + + + + + + + + + | 58 | Angiectasis | | 4 1.0| Hematopoietic Cell Proliferation | | 9 2.2| Hyperplasia | | 4 2.0| __________________________________________________________________________|____________| Thymus | + + + M + + + M + + | 48 | _____________________________________________________________________________________________________________________| | INTEGUMENTARY SYSTEM | | | | | | __________________________________________________________________________|____________| Mammary Gland | M M M M M M M M M M | 1 | __________________________________________________________________________|____________| Skin | + + + + + + + + + + | 60 | _____________________________________________________________________________________________________________________| | MUSCULOSKELETAL SYSTEM | | | | | | __________________________________________________________________________|____________| Bone | + + + + + + + + + + | 60 | __________________________________________________________________________|____________| Skeletal Muscle | + + | 3 | _____________________________________________________________________________________________________________________| | NERVOUS SYSTEM | | | | | | __________________________________________________________________________|____________| Brain | + + + + + + + + + + | 60 | __________________________________________________________________________________________________________________________________ * : 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: 05108-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:51:25 __________________________________________________________________________________________________________________________________ | 7| 7| 4| 7| 1| 7| 7| 4| 2| 7| | | DAY ON TEST | 3| 3| 5| 3| 2| 3| 3| 6| 1| 3| | | | 2| 3| 8| 3| 8| 3| 3| 0| 1| 3| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | B6C3F1 MICE MALE | 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| | T | ANIMAL ID | 1| 1| 1| 1| 1| 1| 1| 1| 1| 2| | A | 11.25 | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| | L | MG/KG | 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| | | __________________________________________________________________________________________________________________________________ NERVOUS SYSTEM - cont | | | | | | _____________________________________________________________________________________________________________________| | RESPIRATORY SYSTEM | | | | | | __________________________________________________________________________|____________| Lung | + + + + + + + + + + | 60 | Hemorrhage | | 3 1.7| Infiltration Cellular, Histiocyte | | 3 2.0| Alveolar Epithelium, Hyperplasia | 2 | 2 2.5| __________________________________________________________________________|____________| Nose | + + + + + + + + + + | 57 | __________________________________________________________________________|____________| Trachea | + + + + + + + + + + | 60 | _____________________________________________________________________________________________________________________| | SPECIAL SENSES SYSTEM | | | | | | __________________________________________________________________________|____________| Eye | + | 3 | Cornea, Inflammation, Acute | | 1 3.0| __________________________________________________________________________|____________| Harderian Gland | + + | 4 | _____________________________________________________________________________________________________________________| | URINARY SYSTEM | | | | | | __________________________________________________________________________|____________| Kidney | + + + + + + + + + + | 60 | Cyst | | 4 | Infiltration Cellular, Plasma Cell | 2 | 1 2.0| Nephropathy | 1 1 | 8 1.3| Renal Tubule, Regeneration | 2 1 | 2 1.5| __________________________________________________________________________|____________| Urinary Bladder | + + + + + + + + + + | 60 | __________________________________________________________________________________________________________________________________ * : 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: 05108-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:51:25 _____________________________________________________________________________________________________________________ | 7| 7| 7| 4| 7| 7| 6| 4| 7| 7| 7| 6| 7| 7| 7| 7| 7| 4| 4| 4| 4| 7| 7| 5| 4| DAY ON TEST | 3| 3| 3| 5| 3| 3| 9| 5| 3| 3| 3| 6| 3| 3| 3| 3| 3| 5| 5| 6| 5| 1| 3| 2| 6| | 0| 0| 0| 8| 0| 0| 3| 8| 0| 0| 0| 6| 0| 0| 0| 0| 0| 3| 8| 0| 8| 0| 0| 2| 0| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| B6C3F1 MICE MALE | 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| ANIMAL ID | 2| 2| 2| 2| 2| 2| 2| 2| 2| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 4| 22.5 | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| MG/KG | 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| _____________________________________________________________________________________________________________________| ALIMENTARY SYSTEM | | | | __________________________________________________________________________| Esophagus | + + + + M + + + + M + + + + + + + + + + + + + + +| __________________________________________________________________________| Gallbladder | + + + + + + A + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Large, Colon | + + + + + + A + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Large, Rectum | + + + + + + A + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Large, Cecum | + + + + + + A + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Small, Duodenum | + + + + + + A + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Small, Jejunum | + + + + + + A + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Small, Ileum | + + + + + + A + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Liver | + + + + + + A + + + + + + + + + + + + + + + + + +| Basophilic Focus | | Clear Cell Focus | X | Eosinophilic Focus | X X X | Fatty Change, Diffuse | | Fatty Change, Focal | 1 | Hematopoietic Cell Proliferation | | Inflammation, Chronic Active | | Mixed Cell Focus | X | Centrilobular, Hypertrophy | 1 | __________________________________________________________________________| Pancreas | + + + + + + M + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Salivary Glands | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Stomach, Forestomach | + + + + + + A + + + + + + + + + + + + + + + + + +| Acanthosis | | Hyperkeratosis | | __________________________________________________________________________| Stomach, Glandular | + + + + + + A + + + + + + + + + + + + + + + + + +| Hyperplasia | | Inflammation, Chronic Active | 2 | _____________________________________________________________________________________________________________________| CARDIOVASCULAR SYSTEM | | | | __________________________________________________________________________| Heart | + + + + + + + + + + + + + + + + + + + + + + + + +| Cardiomyopathy | 1 2 | Mineralization | 2 | Artery, Inflammation, Chronic Active | | _____________________________________________________________________________________________________________________| ENDOCRINE SYSTEM | | | | __________________________________________________________________________| Adrenal Cortex | + + + + + + M + + + + + + + + + + + + + + + + + +| Accessory Adrenal Cortical Nodule | | Hypertrophy | 1 1 2 | __________________________________________________________________________| Adrenal Medulla | + + + + + + M + + + M + + + + + + + + + + + + + +| __________________________________________________________________________| Islets, Pancreatic | + + + + + + M + + + + + + + + + + + + + + + + + +| Hyperplasia | 2 1 | __________________________________________________________________________| Parathyroid Gland | + + + M M + M + + M + M M + + + M M + + + + + + M| __________________________________________________________________________| Pituitary Gland | + + + + + + + + + + + + + + M + + + + + + + + + +| Pars Distalis, Cyst | | Pars Distalis, Hyperplasia | 1 | _____________________________________________________________________________________________________________________| Page 56 NTP Experiment-Test: 05108-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:51:25 _____________________________________________________________________________________________________________________ | 7| 7| 7| 4| 7| 7| 6| 4| 7| 7| 7| 6| 7| 7| 7| 7| 7| 4| 4| 4| 4| 7| 7| 5| 4| DAY ON TEST | 3| 3| 3| 5| 3| 3| 9| 5| 3| 3| 3| 6| 3| 3| 3| 3| 3| 5| 5| 6| 5| 1| 3| 2| 6| | 0| 0| 0| 8| 0| 0| 3| 8| 0| 0| 0| 6| 0| 0| 0| 0| 0| 3| 8| 0| 8| 0| 0| 2| 0| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| B6C3F1 MICE MALE | 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| ANIMAL ID | 2| 2| 2| 2| 2| 2| 2| 2| 2| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 4| 22.5 | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| MG/KG | 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| _____________________________________________________________________________________________________________________| ENDOCRINE SYSTEM - cont | | | | __________________________________________________________________________| Thyroid Gland | + + + + M + + + + M + + + + + + + + + + + + + + +| Artery, Inflammation, Chronic Active | | Follicular Cell, Hyperplasia | | _____________________________________________________________________________________________________________________| GENERAL BODY SYSTEM | | | | __________________________________________________________________________| Tissue NOS | | _____________________________________________________________________________________________________________________| GENITAL SYSTEM | | | | __________________________________________________________________________| Epididymis | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Preputial Gland | + + + + + + + +| Dilatation | 2 2 2 2 2 | __________________________________________________________________________| Prostate | + + + M + + M + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Seminal Vesicle | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Testes | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| HEMATOPOIETIC SYSTEM | | | | __________________________________________________________________________| Bone Marrow | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Lymph Node | + + + | Mediastinal, Angiectasis | | __________________________________________________________________________| Lymph Node, Mandibular | + + + M + M + + + + + + M M + + + + + + + + + M M| __________________________________________________________________________| Lymph Node, Mesenteric | + + M + + + + + + M + + + M + + + + + + + + + + +| Infiltration Cellular, Histiocyte | | Artery, Inflammation, Chronic Active | | __________________________________________________________________________| Spleen | + + + + + + + + + + + + + + + + + + + + + + + + +| Angiectasis | | Hematopoietic Cell Proliferation | 2 | Necrosis | 3 | __________________________________________________________________________| Thymus | + + M + + M M + + + + + + + M + + + + + + + + + +| _____________________________________________________________________________________________________________________| INTEGUMENTARY SYSTEM | | | | __________________________________________________________________________| Mammary Gland | M M M M M M M M M M M M M M M M M M M M M M M M M| __________________________________________________________________________| Skin | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| MUSCULOSKELETAL SYSTEM | | | | __________________________________________________________________________| Bone | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Skeletal Muscle | + | _____________________________________________________________________________________________________________________| NERVOUS SYSTEM | | | | __________________________________________________________________________| Brain | + + + + + + + + + + + + + + + + + + + + + + + + +| Inflammation, Chronic Active | | __________________________________________________________________________| Spinal Cord | | _____________________________________________________________________________________________________________________| RESPIRATORY SYSTEM | | | | __________________________________________________________________________| Lung | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| Page 57 NTP Experiment-Test: 05108-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:51:25 _____________________________________________________________________________________________________________________ | 7| 7| 7| 4| 7| 7| 6| 4| 7| 7| 7| 6| 7| 7| 7| 7| 7| 4| 4| 4| 4| 7| 7| 5| 4| DAY ON TEST | 3| 3| 3| 5| 3| 3| 9| 5| 3| 3| 3| 6| 3| 3| 3| 3| 3| 5| 5| 6| 5| 1| 3| 2| 6| | 0| 0| 0| 8| 0| 0| 3| 8| 0| 0| 0| 6| 0| 0| 0| 0| 0| 3| 8| 0| 8| 0| 0| 2| 0| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| B6C3F1 MICE MALE | 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| ANIMAL ID | 2| 2| 2| 2| 2| 2| 2| 2| 2| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 4| 22.5 | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| MG/KG | 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| _____________________________________________________________________________________________________________________| RESPIRATORY SYSTEM - cont | | | | Hemorrhage | 2 | Alveolar Epithelium, Hyperplasia | 2 | __________________________________________________________________________| Nose | + + + + + + + + + + + + + + + + + + + + + + + + +| Inflammation, Acute | | __________________________________________________________________________| Trachea | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| SPECIAL SENSES SYSTEM | | | | __________________________________________________________________________| Ear | | __________________________________________________________________________| Harderian Gland | + | _____________________________________________________________________________________________________________________| URINARY SYSTEM | | | | __________________________________________________________________________| Kidney | + + + + + + + + + + + + + + + + + + + + + + + + +| Infarct | 3 | Nephropathy | 1 1 1 | Artery, Inflammation, Chronic Active | | Cortex, Mineralization | 1 2 | Papilla, Mineralization | 2 | Renal Tubule, Regeneration | 1 1 1| __________________________________________________________________________| Urinary Bladder | + + + + + + A + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| Page 58 NTP Experiment-Test: 05108-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:51:25 _____________________________________________________________________________________________________________________ | 7| 7| 7| 7| 5| 7| 7| 7| 7| 4| 7| 7| 7| 5| 7| 4| 7| 7| 7| 7| 7| 4| 5| 7| 7| DAY ON TEST | 2| 3| 3| 3| 2| 3| 3| 3| 3| 6| 3| 3| 3| 2| 3| 4| 3| 3| 3| 3| 3| 6| 2| 3| 3| | 5| 0| 0| 0| 8| 0| 0| 0| 0| 0| 0| 0| 0| 7| 0| 4| 0| 0| 0| 0| 0| 0| 6| 0| 1| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| B6C3F1 MICE MALE | 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| ANIMAL ID | 4| 4| 4| 4| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 7| 22.5 | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| MG/KG | 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| _____________________________________________________________________________________________________________________| ALIMENTARY SYSTEM | | | | __________________________________________________________________________| Esophagus | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Gallbladder | M + + + + + M + + + + + + + + M + + + + + + A + +| __________________________________________________________________________| Intestine Large, Colon | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Large, Rectum | + + + + + + + + + + + + + + + A + + + + + + M + +| __________________________________________________________________________| Intestine Large, Cecum | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Small, Duodenum | + + + + + + M + + + + + + + + A + + + + + + M + +| __________________________________________________________________________| Intestine Small, Jejunum | + + + + + + + + + + + + + + + A + + + + + + M + +| __________________________________________________________________________| Intestine Small, Ileum | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Liver | + + + + + + + + + + + + + + + + + + + + + + + + +| Basophilic Focus | X | Clear Cell Focus | | Eosinophilic Focus | X X X | Fatty Change, Diffuse | 1 | Fatty Change, Focal | | Hematopoietic Cell Proliferation | 4 | Inflammation, Chronic Active | 3| Mixed Cell Focus | | Centrilobular, Hypertrophy | 1 1 1 1 1 | __________________________________________________________________________| Pancreas | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Salivary Glands | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Stomach, Forestomach | + + + + + + + + + + + + + + + + + + + + + + + + +| Acanthosis | | Hyperkeratosis | | __________________________________________________________________________| Stomach, Glandular | + + + + + + + + + + + + + + + + + + + + + + + + +| Hyperplasia | | Inflammation, Chronic Active | | _____________________________________________________________________________________________________________________| CARDIOVASCULAR SYSTEM | | | | __________________________________________________________________________| Heart | + + + + + + + + + + + + + + + + + + + + + + + + +| Cardiomyopathy | | Mineralization | | Artery, Inflammation, Chronic Active | 2 | _____________________________________________________________________________________________________________________| ENDOCRINE SYSTEM | | | | __________________________________________________________________________| Adrenal Cortex | + + + + + + + + + + + + + + + + + + + + + + + + +| Accessory Adrenal Cortical Nodule | X | Hypertrophy | 1 2 2 1 1 | __________________________________________________________________________| Adrenal Medulla | + + + + + M + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Islets, Pancreatic | + + + + + + + + + + + + + + + + + + + + + + + + +| Hyperplasia | | __________________________________________________________________________| Parathyroid Gland | + + + + + + + + + M + + + + M + + + + + + + + M +| __________________________________________________________________________| Pituitary Gland | + + + + + + + M + + + + M + + + + + M + + + + + +| Pars Distalis, Cyst | X | Pars Distalis, Hyperplasia | | _____________________________________________________________________________________________________________________| Page 59 NTP Experiment-Test: 05108-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:51:25 _____________________________________________________________________________________________________________________ | 7| 7| 7| 7| 5| 7| 7| 7| 7| 4| 7| 7| 7| 5| 7| 4| 7| 7| 7| 7| 7| 4| 5| 7| 7| DAY ON TEST | 2| 3| 3| 3| 2| 3| 3| 3| 3| 6| 3| 3| 3| 2| 3| 4| 3| 3| 3| 3| 3| 6| 2| 3| 3| | 5| 0| 0| 0| 8| 0| 0| 0| 0| 0| 0| 0| 0| 7| 0| 4| 0| 0| 0| 0| 0| 0| 6| 0| 1| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| B6C3F1 MICE MALE | 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| ANIMAL ID | 4| 4| 4| 4| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 7| 22.5 | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| MG/KG | 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| _____________________________________________________________________________________________________________________| ENDOCRINE SYSTEM - cont | | | | __________________________________________________________________________| Thyroid Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| Artery, Inflammation, Chronic Active | 3 | Follicular Cell, Hyperplasia | 1 2 2 | _____________________________________________________________________________________________________________________| GENERAL BODY SYSTEM | | | | __________________________________________________________________________| Tissue NOS | + | _____________________________________________________________________________________________________________________| GENITAL SYSTEM | | | | __________________________________________________________________________| Epididymis | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Preputial Gland | + + + + + + + | Dilatation | 2 2 2 2 2 2 | __________________________________________________________________________| Prostate | + + + + + + + + + + + + M + + + + + + + + + + + +| __________________________________________________________________________| Seminal Vesicle | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Testes | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| HEMATOPOIETIC SYSTEM | | | | __________________________________________________________________________| Bone Marrow | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Lymph Node | + | Mediastinal, Angiectasis | X | __________________________________________________________________________| Lymph Node, Mandibular | + + + + + + + + + M + + + + + + + + + + + + + + +| __________________________________________________________________________| Lymph Node, Mesenteric | + + + + + + + + + + + + + + + + + + M + + + M + +| Infiltration Cellular, Histiocyte | 2 | Artery, Inflammation, Chronic Active | 2 | __________________________________________________________________________| Spleen | + + + + + + + + + + + + + + + + + + + + + + + + +| Angiectasis | 2 | Hematopoietic Cell Proliferation | 2 2 2 | Necrosis | | __________________________________________________________________________| Thymus | M + + + + + + + + + + + + + + + + + + M M + + + M| _____________________________________________________________________________________________________________________| INTEGUMENTARY SYSTEM | | | | __________________________________________________________________________| Mammary Gland | M M M M M M + M M M M M M M M M M M M M M M M M M| __________________________________________________________________________| Skin | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| MUSCULOSKELETAL SYSTEM | | | | __________________________________________________________________________| Bone | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Skeletal Muscle | | _____________________________________________________________________________________________________________________| NERVOUS SYSTEM | | | | __________________________________________________________________________| Brain | + + + + + + + + + + + + + + + + + + + + + + + + +| Inflammation, Chronic Active | 1 | __________________________________________________________________________| Spinal Cord | + | _____________________________________________________________________________________________________________________| RESPIRATORY SYSTEM | | | | __________________________________________________________________________| Lung | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| Page 60 NTP Experiment-Test: 05108-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:51:25 _____________________________________________________________________________________________________________________ | 7| 7| 7| 7| 5| 7| 7| 7| 7| 4| 7| 7| 7| 5| 7| 4| 7| 7| 7| 7| 7| 4| 5| 7| 7| DAY ON TEST | 2| 3| 3| 3| 2| 3| 3| 3| 3| 6| 3| 3| 3| 2| 3| 4| 3| 3| 3| 3| 3| 6| 2| 3| 3| | 5| 0| 0| 0| 8| 0| 0| 0| 0| 0| 0| 0| 0| 7| 0| 4| 0| 0| 0| 0| 0| 0| 6| 0| 1| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| B6C3F1 MICE MALE | 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| ANIMAL ID | 4| 4| 4| 4| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 7| 22.5 | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| MG/KG | 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| _____________________________________________________________________________________________________________________| RESPIRATORY SYSTEM - cont | | | | Hemorrhage | 2 2 | Alveolar Epithelium, Hyperplasia | 1 | __________________________________________________________________________| Nose | + + + + + + + + + + + + + + + + + + + + + + + + +| Inflammation, Acute | 2 | __________________________________________________________________________| Trachea | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| SPECIAL SENSES SYSTEM | | | | __________________________________________________________________________| Ear | + | __________________________________________________________________________| Harderian Gland | + | _____________________________________________________________________________________________________________________| URINARY SYSTEM | | | | __________________________________________________________________________| Kidney | + + + + + + + + + + + + + + + + + + + + + + + + +| Infarct | | Nephropathy | 2 2 1 1| Artery, Inflammation, Chronic Active | 1 | Cortex, Mineralization | | Papilla, Mineralization | | Renal Tubule, Regeneration | 1 1 | __________________________________________________________________________| Urinary Bladder | + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| Page 61 NTP Experiment-Test: 05108-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:51:25 __________________________________________________________________________________________________________________________________ | 7| 4| 7| 7| 7| 7| 7| 4| 7| 7| | | DAY ON TEST | 3| 6| 3| 3| 3| 3| 3| 6| 3| 3| | | | 1| 0| 1| 1| 1| 1| 1| 0| 1| 1| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | B6C3F1 MICE MALE | 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| | T | ANIMAL ID | 7| 7| 7| 7| 7| 7| 7| 7| 7| 8| | A | 22.5 | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| | L | MG/KG | 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| | | __________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM | | | | | | __________________________________________________________________________|____________| Esophagus | + + + + + + + + + + | 58 | __________________________________________________________________________|____________| Gallbladder | + + + + + + + + + + | 55 | __________________________________________________________________________|____________| Intestine Large, Colon | + + + + + + + + + + | 59 | __________________________________________________________________________|____________| Intestine Large, Rectum | + + + + + + + + + + | 57 | __________________________________________________________________________|____________| Intestine Large, Cecum | + + + + + + + + + + | 59 | __________________________________________________________________________|____________| Intestine Small, Duodenum | + + + + + + + + + + | 56 | __________________________________________________________________________|____________| Intestine Small, Jejunum | + + + + + + + + + + | 57 | __________________________________________________________________________|____________| Intestine Small, Ileum | + + + + + + + + + + | 59 | __________________________________________________________________________|____________| Liver | + + + + + + + + + + | 59 | Basophilic Focus | X | 2 | Clear Cell Focus | X | 2 | Eosinophilic Focus | X X X X | 10 | Fatty Change, Diffuse | | 1 1.0| Fatty Change, Focal | 1 | 2 1.0| Hematopoietic Cell Proliferation | | 1 4.0| Inflammation, Chronic Active | | 1 3.0| Mixed Cell Focus | | 1 | Centrilobular, Hypertrophy | | 6 1.0| __________________________________________________________________________|____________| Pancreas | + + + + + + + + + + | 59 | __________________________________________________________________________|____________| Salivary Glands | + + + + + + + + + + | 60 | __________________________________________________________________________|____________| Stomach, Forestomach | + + + + + + + + + + | 59 | Acanthosis | 2 | 1 2.0| Hyperkeratosis | 1 | 1 1.0| __________________________________________________________________________|____________| Stomach, Glandular | + + + + + + + + + + | 59 | Hyperplasia | 2 | 1 2.0| Inflammation, Chronic Active | | 1 2.0| _____________________________________________________________________________________________________________________| | CARDIOVASCULAR SYSTEM | | | | | | __________________________________________________________________________|____________| Heart | + + + + + + + + + + | 60 | Cardiomyopathy | | 2 1.5| Mineralization | | 1 2.0| Artery, Inflammation, Chronic Active | | 1 2.0| _____________________________________________________________________________________________________________________| | ENDOCRINE SYSTEM | | | | | | __________________________________________________________________________|____________| Adrenal Cortex | + + + M + + + + + + | 58 | Accessory Adrenal Cortical Nodule | | 1 | Hypertrophy | | 8 1.4| __________________________________________________________________________|____________| Adrenal Medulla | + + + M + + + + + + | 56 | __________________________________________________________________________|____________| Islets, Pancreatic | + + + + + + + + + + | 59 | __________________________________________________________________________________________________________________________________ * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 62 NTP Experiment-Test: 05108-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:51:25 __________________________________________________________________________________________________________________________________ | 7| 4| 7| 7| 7| 7| 7| 4| 7| 7| | | DAY ON TEST | 3| 6| 3| 3| 3| 3| 3| 6| 3| 3| | | | 1| 0| 1| 1| 1| 1| 1| 0| 1| 1| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | B6C3F1 MICE MALE | 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| | T | ANIMAL ID | 7| 7| 7| 7| 7| 7| 7| 7| 7| 8| | A | 22.5 | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| | L | MG/KG | 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| | | __________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM - cont | | | | | | Hyperplasia | 2 | 3 1.7| __________________________________________________________________________|____________| Parathyroid Gland | + + + + + M M M + M | 44 | __________________________________________________________________________|____________| Pituitary Gland | + + + + + + M + + + | 55 | Pars Distalis, Cyst | | 1 | Pars Distalis, Hyperplasia | | 1 1.0| __________________________________________________________________________|____________| Thyroid Gland | + + + + + + + + + + | 58 | Artery, Inflammation, Chronic Active | | 1 3.0| Follicular Cell, Hyperplasia | | 3 1.7| _____________________________________________________________________________________________________________________| | GENERAL BODY SYSTEM | | | | | | __________________________________________________________________________|____________| Tissue NOS | | 1 | _____________________________________________________________________________________________________________________| | GENITAL SYSTEM | | | | | | __________________________________________________________________________|____________| Epididymis | + + + + + + + + + + | 60 | __________________________________________________________________________|____________| Preputial Gland | + + + + + | 20 | Dilatation | 3 2 2 2 3 | 16 2.1| __________________________________________________________________________|____________| Prostate | + + + + + + + + + + | 57 | __________________________________________________________________________|____________| Seminal Vesicle | + + + + + + + + + + | 60 | __________________________________________________________________________|____________| Testes | + + + + + + + + + + | 60 | _____________________________________________________________________________________________________________________| | HEMATOPOIETIC SYSTEM | | | | | | __________________________________________________________________________|____________| Bone Marrow | + + + + + + + + + + | 60 | __________________________________________________________________________|____________| Lymph Node | | 4 | Mediastinal, Angiectasis | | 1 | __________________________________________________________________________|____________| Lymph Node, Mandibular | + + + + + + + + + + | 53 | __________________________________________________________________________|____________| Lymph Node, Mesenteric | M + + + + M + + + + | 53 | Infiltration Cellular, Histiocyte | | 1 2.0| Artery, Inflammation, Chronic Active | | 1 2.0| __________________________________________________________________________|____________| Spleen | + + + + + + + + + + | 60 | Angiectasis | | 1 2.0| Hematopoietic Cell Proliferation | 2 2 | 6 2.0| Necrosis | | 1 3.0| __________________________________________________________________________|____________| Thymus | + + + + + + + + + + | 52 | _____________________________________________________________________________________________________________________| | INTEGUMENTARY SYSTEM | | | | | | __________________________________________________________________________|____________| Mammary Gland | M M M M M M M M M M | 1 | __________________________________________________________________________|____________| Skin | + + + + + + + + + + | 60 | _____________________________________________________________________________________________________________________| | MUSCULOSKELETAL SYSTEM | | | | | | __________________________________________________________________________________________________________________________________ * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 63 NTP Experiment-Test: 05108-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:51:25 __________________________________________________________________________________________________________________________________ | 7| 4| 7| 7| 7| 7| 7| 4| 7| 7| | | DAY ON TEST | 3| 6| 3| 3| 3| 3| 3| 6| 3| 3| | | | 1| 0| 1| 1| 1| 1| 1| 0| 1| 1| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | B6C3F1 MICE MALE | 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| | T | ANIMAL ID | 7| 7| 7| 7| 7| 7| 7| 7| 7| 8| | A | 22.5 | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| | L | MG/KG | 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| | | __________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM - cont | | | | | | __________________________________________________________________________|____________| Bone | + + + + + + + + + + | 60 | __________________________________________________________________________|____________| Skeletal Muscle | | 1 | _____________________________________________________________________________________________________________________| | NERVOUS SYSTEM | | | | | | __________________________________________________________________________|____________| Brain | + + + + + + + + + + | 60 | Inflammation, Chronic Active | | 1 1.0| __________________________________________________________________________|____________| Spinal Cord | | 1 | _____________________________________________________________________________________________________________________| | RESPIRATORY SYSTEM | | | | | | __________________________________________________________________________|____________| Lung | + + + + + + + + + + | 60 | Hemorrhage | | 3 2.0| Alveolar Epithelium, Hyperplasia | | 2 1.5| __________________________________________________________________________|____________| Nose | + + + + + + + + + + | 60 | Inflammation, Acute | 1 | 2 1.5| __________________________________________________________________________|____________| Trachea | + + + + + + + + + + | 60 | _____________________________________________________________________________________________________________________| | SPECIAL SENSES SYSTEM | | | | | | __________________________________________________________________________|____________| Ear | | 1 | __________________________________________________________________________|____________| Harderian Gland | | 2 | _____________________________________________________________________________________________________________________| | URINARY SYSTEM | | | | | | __________________________________________________________________________|____________| Kidney | + + + + + + + + + + | 60 | Infarct | | 1 3.0| Nephropathy | 1 1 | 9 1.2| Artery, Inflammation, Chronic Active | | 1 1.0| Cortex, Mineralization | | 2 1.5| Papilla, Mineralization | | 1 2.0| Renal Tubule, Regeneration | 2 | 6 1.2| __________________________________________________________________________|____________| Urinary Bladder | + + + + + + + + + + | 58 | __________________________________________________________________________________________________________________________________ * : 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 64 NTP Experiment-Test: 05108-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:51:25 _____________________________________________________________________________________________________________________ | 4| 4| 7| 7| 7| 7| 4| 4| 4| 7| 7| 6| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| DAY ON TEST | 6| 6| 2| 2| 2| 2| 5| 6| 5| 2| 2| 3| 2| 2| 1| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| | 0| 0| 9| 9| 9| 9| 8| 0| 8| 9| 9| 1| 9| 9| 3| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| B6C3F1 MICE MALE | 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 2| ANIMAL ID | 8| 8| 8| 8| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 0| 0| 0| 0| 0| 0| 45.0 | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| MG/KG | 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| _____________________________________________________________________________________________________________________| ALIMENTARY SYSTEM | | | | __________________________________________________________________________| Esophagus | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Gallbladder | + + + + + + + + + + + + + + + + + + + + M M + + +| __________________________________________________________________________| Intestine Large, Colon | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Large, Rectum | + + + + + + + + + + + + + + + + + + M + + + + + M| __________________________________________________________________________| Intestine Large, Cecum | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Small, Duodenum | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Small, Jejunum | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Small, Ileum | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Liver | + + + + + + + + + + + + + + + + + + + + + + + + +| Basophilic Focus | X X | Clear Cell Focus | | Eosinophilic Focus | X X X X X| Eosinophilic Focus, Multiple | X | Fatty Change, Diffuse | 2 | Fatty Change, Focal | 1 1 1 | Fatty Change | 1| Fibrosis | 2 | Inflammation, Focal, Necrotizing | 1 | Mixed Cell Focus | X X | Necrosis, Focal | 1 1 | Centrilobular, Hypertrophy | 1 1 | __________________________________________________________________________| Mesentery | | Inflammation, Chronic Active | | __________________________________________________________________________| Pancreas | + + + + + + + + + + + + + + + + + + + + + + + + +| Duct, Cyst | X | __________________________________________________________________________| Salivary Glands | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Stomach, Forestomach | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Stomach, Glandular | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Tongue | + | Mineralization | | _____________________________________________________________________________________________________________________| CARDIOVASCULAR SYSTEM | | | | __________________________________________________________________________| Heart | + + + + + + + + + + + + + + + + + + + + + + + + +| Cardiomyopathy | | _____________________________________________________________________________________________________________________| ENDOCRINE SYSTEM | | | | __________________________________________________________________________| Adrenal Cortex | + + + + + + + + + + + + + + + + + + + + + + + + +| Hyperplasia | 2 2 | Hypertrophy | 1 | __________________________________________________________________________| Adrenal Medulla | + + + + + + + + + + + + + + + + + + + + M + + + +| __________________________________________________________________________| Islets, Pancreatic | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Parathyroid Gland | + + M + M + M M M M + + + + M + + + + + + M + M +| __________________________________________________________________________| Pituitary Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| Pars Distalis, Hyperplasia | | _____________________________________________________________________________________________________________________| Page 65 NTP Experiment-Test: 05108-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:51:25 _____________________________________________________________________________________________________________________ | 4| 4| 7| 7| 7| 7| 4| 4| 4| 7| 7| 6| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| DAY ON TEST | 6| 6| 2| 2| 2| 2| 5| 6| 5| 2| 2| 3| 2| 2| 1| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| | 0| 0| 9| 9| 9| 9| 8| 0| 8| 9| 9| 1| 9| 9| 3| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| B6C3F1 MICE MALE | 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 2| ANIMAL ID | 8| 8| 8| 8| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 0| 0| 0| 0| 0| 0| 45.0 | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| MG/KG | 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| _____________________________________________________________________________________________________________________| ENDOCRINE SYSTEM - cont | | | | __________________________________________________________________________| Thyroid Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| Follicular Cell, Hyperplasia | | _____________________________________________________________________________________________________________________| GENERAL BODY SYSTEM | | | | None | | _____________________________________________________________________________________________________________________| GENITAL SYSTEM | | | | __________________________________________________________________________| Epididymis | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Preputial Gland | + + + + + + + + +| Dilatation | 2 2 3 2 2 2 2 2| __________________________________________________________________________| Prostate | + + + + M + + + M + + + + + + + + + + + + + + + +| __________________________________________________________________________| Seminal Vesicle | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Testes | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| HEMATOPOIETIC SYSTEM | | | | __________________________________________________________________________| Bone Marrow | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Lymph Node | | __________________________________________________________________________| Lymph Node, Mandibular | M + + + + + M M + + + + + + + + + + + + + M + + +| __________________________________________________________________________| Lymph Node, Mesenteric | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Spleen | + + + + + + + + + + + + + + + + + + + + + + + + +| Hematopoietic Cell Proliferation | | __________________________________________________________________________| Thymus | + + + M + + + + + + + + M + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| INTEGUMENTARY SYSTEM | | | | __________________________________________________________________________| Mammary Gland | M M M M M M M M M M M M M M M M M M M M M M M M M| __________________________________________________________________________| Skin | + + + + + + + + + + + + + + + + + + + + + + + + +| Necrosis | | _____________________________________________________________________________________________________________________| MUSCULOSKELETAL SYSTEM | | | | __________________________________________________________________________| Bone | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Skeletal Muscle | | _____________________________________________________________________________________________________________________| NERVOUS SYSTEM | | | | __________________________________________________________________________| Brain | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| RESPIRATORY SYSTEM | | | | __________________________________________________________________________| Lung | + + + + + + + + + + + + + + + + + + + + + + + + +| Hemorrhage | | Infiltration Cellular, Histiocyte | | Alveolar Epithelium, Hyperplasia | | __________________________________________________________________________| Nose | + + + + + + + M + + + + + M + + + + + + + + + + +| Inflammation, Acute | 1 1 | __________________________________________________________________________| Trachea | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| SPECIAL SENSES SYSTEM | | _____________________________________________________________________________________________________________________| Page 66 NTP Experiment-Test: 05108-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:51:25 _____________________________________________________________________________________________________________________ | 4| 4| 7| 7| 7| 7| 4| 4| 4| 7| 7| 6| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| DAY ON TEST | 6| 6| 2| 2| 2| 2| 5| 6| 5| 2| 2| 3| 2| 2| 1| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| | 0| 0| 9| 9| 9| 9| 8| 0| 8| 9| 9| 1| 9| 9| 3| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| B6C3F1 MICE MALE | 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 2| ANIMAL ID | 8| 8| 8| 8| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 0| 0| 0| 0| 0| 0| 45.0 | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| MG/KG | 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| _____________________________________________________________________________________________________________________| SPECIAL SENSES SYSTEM - cont | | | | | | __________________________________________________________________________| Harderian Gland | + + | Hyperplasia | 1 | _____________________________________________________________________________________________________________________| URINARY SYSTEM | | | | __________________________________________________________________________| Kidney | + + + + + + + + + + + + + + + + + + + + + + + + +| Cyst | X | Nephropathy | 2 1 1 | Renal Tubule, Regeneration | 1 | __________________________________________________________________________| Urinary Bladder | + + + + + + + + + + + + + + + + + + + + + + + + +| Calculus Gross Observation | X | Calculus Micro Observation Only | X | _____________________________________________________________________________________________________________________| Page 67 NTP Experiment-Test: 05108-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:51:25 _____________________________________________________________________________________________________________________ | 7| 7| 5| 7| 7| 7| 4| 7| 4| 7| 7| 7| 7| 7| 7| 7| 7| 7| 4| 7| 7| 6| 7| 4| 4| DAY ON TEST | 2| 2| 6| 2| 2| 2| 6| 2| 6| 2| 2| 2| 2| 2| 2| 0| 3| 3| 6| 3| 3| 9| 3| 5| 5| | 9| 9| 8| 9| 9| 9| 0| 9| 0| 9| 9| 9| 9| 9| 9| 3| 0| 0| 0| 0| 0| 6| 0| 8| 8| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| B6C3F1 MICE MALE | 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| ANIMAL ID | 0| 0| 0| 0| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 3| 45.0 | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| MG/KG | 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| _____________________________________________________________________________________________________________________| ALIMENTARY SYSTEM | | | | __________________________________________________________________________| Esophagus | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Gallbladder | + + + + + + + + + + + + + M M + + + + + + + + + +| __________________________________________________________________________| Intestine Large, Colon | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Large, Rectum | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Large, Cecum | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Small, Duodenum | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Small, Jejunum | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Small, Ileum | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Liver | + + + + + + + + + + + + + + + + + + + + + + + + +| Basophilic Focus | | Clear Cell Focus | | Eosinophilic Focus | X X X | Eosinophilic Focus, Multiple | | Fatty Change, Diffuse | | Fatty Change, Focal | 1 2 2 | Fatty Change | | Fibrosis | | Inflammation, Focal, Necrotizing | | Mixed Cell Focus | X X X | Necrosis, Focal | | Centrilobular, Hypertrophy | 1 1 1 1 | __________________________________________________________________________| Mesentery | + + | Inflammation, Chronic Active | 3 | __________________________________________________________________________| Pancreas | + + + + + + + + + + + + + + + + + + + + + + + + +| Duct, Cyst | | __________________________________________________________________________| Salivary Glands | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Stomach, Forestomach | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Stomach, Glandular | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Tongue | + | Mineralization | 1 | _____________________________________________________________________________________________________________________| CARDIOVASCULAR SYSTEM | | | | __________________________________________________________________________| Heart | + + + + + + + + + + + + + + + + + + + + + + + + +| Cardiomyopathy | 1 | _____________________________________________________________________________________________________________________| ENDOCRINE SYSTEM | | | | __________________________________________________________________________| Adrenal Cortex | + + + + + + + + M + + + + + + + M + + + + + + + +| Hyperplasia | 2 | Hypertrophy | 1 | __________________________________________________________________________| Adrenal Medulla | + + + + + + + + M + + + + + + + M + + + + + + + +| __________________________________________________________________________| Islets, Pancreatic | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Parathyroid Gland | M + + + + + M M M + + + M M + M + + + + + M + + +| __________________________________________________________________________| Pituitary Gland | + + + + M M + + + + + + M + + + + + + + + + + + +| Pars Distalis, Hyperplasia | 1 | _____________________________________________________________________________________________________________________| Page 68 NTP Experiment-Test: 05108-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:51:25 _____________________________________________________________________________________________________________________ | 7| 7| 5| 7| 7| 7| 4| 7| 4| 7| 7| 7| 7| 7| 7| 7| 7| 7| 4| 7| 7| 6| 7| 4| 4| DAY ON TEST | 2| 2| 6| 2| 2| 2| 6| 2| 6| 2| 2| 2| 2| 2| 2| 0| 3| 3| 6| 3| 3| 9| 3| 5| 5| | 9| 9| 8| 9| 9| 9| 0| 9| 0| 9| 9| 9| 9| 9| 9| 3| 0| 0| 0| 0| 0| 6| 0| 8| 8| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| B6C3F1 MICE MALE | 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| ANIMAL ID | 0| 0| 0| 0| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 3| 45.0 | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| MG/KG | 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| _____________________________________________________________________________________________________________________| ENDOCRINE SYSTEM - cont | | | | __________________________________________________________________________| Thyroid Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| Follicular Cell, Hyperplasia | 1 | _____________________________________________________________________________________________________________________| GENERAL BODY SYSTEM | | | | None | | _____________________________________________________________________________________________________________________| GENITAL SYSTEM | | | | __________________________________________________________________________| Epididymis | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Preputial Gland | + + + + + + + + + | Dilatation | 2 2 2 2 2 2 2 | __________________________________________________________________________| Prostate | + + + + + M + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Seminal Vesicle | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Testes | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| HEMATOPOIETIC SYSTEM | | | | __________________________________________________________________________| Bone Marrow | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Lymph Node | + | __________________________________________________________________________| Lymph Node, Mandibular | + + + + + + + + + + + + + + + + + + + + M + + + +| __________________________________________________________________________| Lymph Node, Mesenteric | + + + + + + + + + + + + + + + M + + + + M M + + +| __________________________________________________________________________| Spleen | + + + + + + + + + + + + + + + + + + + + + + + + +| Hematopoietic Cell Proliferation | 3 | __________________________________________________________________________| Thymus | + + + + + + + + + + + + + M + + + + + + M M M + +| _____________________________________________________________________________________________________________________| INTEGUMENTARY SYSTEM | | | | __________________________________________________________________________| Mammary Gland | M M M M M M M M M M M M M M M M M M M M M M M M M| __________________________________________________________________________| Skin | + + + + + + + + + + + + + + + + + + + + + + + + +| Necrosis | | _____________________________________________________________________________________________________________________| MUSCULOSKELETAL SYSTEM | | | | __________________________________________________________________________| Bone | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Skeletal Muscle | + | _____________________________________________________________________________________________________________________| NERVOUS SYSTEM | | | | __________________________________________________________________________| Brain | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| RESPIRATORY SYSTEM | | | | __________________________________________________________________________| Lung | + + + + + + + + + + + + + + + + + + + + + + + + +| Hemorrhage | 2 | Infiltration Cellular, Histiocyte | | Alveolar Epithelium, Hyperplasia | 3 | __________________________________________________________________________| Nose | + + + + + + + M + + + + + + + + + + + + + + + + +| Inflammation, Acute | | __________________________________________________________________________| Trachea | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| SPECIAL SENSES SYSTEM | | _____________________________________________________________________________________________________________________| Page 69 NTP Experiment-Test: 05108-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:51:25 _____________________________________________________________________________________________________________________ | 7| 7| 5| 7| 7| 7| 4| 7| 4| 7| 7| 7| 7| 7| 7| 7| 7| 7| 4| 7| 7| 6| 7| 4| 4| DAY ON TEST | 2| 2| 6| 2| 2| 2| 6| 2| 6| 2| 2| 2| 2| 2| 2| 0| 3| 3| 6| 3| 3| 9| 3| 5| 5| | 9| 9| 8| 9| 9| 9| 0| 9| 0| 9| 9| 9| 9| 9| 9| 3| 0| 0| 0| 0| 0| 6| 0| 8| 8| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| B6C3F1 MICE MALE | 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| ANIMAL ID | 0| 0| 0| 0| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 3| 45.0 | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| MG/KG | 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| _____________________________________________________________________________________________________________________| SPECIAL SENSES SYSTEM - cont | | | | | | __________________________________________________________________________| Harderian Gland | + | Hyperplasia | | _____________________________________________________________________________________________________________________| URINARY SYSTEM | | | | __________________________________________________________________________| Kidney | + + + + + + + + + + + + + + + + + + + + + + + + +| Cyst | X | Nephropathy | 2 3 | Renal Tubule, Regeneration | 1 1 | __________________________________________________________________________| Urinary Bladder | + + + + + + + + + + + + + + M + + + + + + + + + +| Calculus Gross Observation | | Calculus Micro Observation Only | X | _____________________________________________________________________________________________________________________| Page 70 NTP Experiment-Test: 05108-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:51:25 __________________________________________________________________________________________________________________________________ | 7| 7| 6| 7| 7| 7| 7| 7| 7| 7| | | DAY ON TEST | 3| 3| 6| 3| 3| 3| 3| 3| 3| 3| | | | 0| 0| 9| 0| 0| 0| 0| 0| 0| 0| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | B6C3F1 MICE MALE | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| | T | ANIMAL ID | 3| 3| 3| 3| 3| 3| 3| 3| 3| 4| | A | 45.0 | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| | L | MG/KG | 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| | | __________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM | | | | | | __________________________________________________________________________|____________| Esophagus | + + + + + + + + + + | 60 | __________________________________________________________________________|____________| Gallbladder | + M + + + + + + + + | 55 | __________________________________________________________________________|____________| Intestine Large, Colon | + + + + + + + + + + | 60 | __________________________________________________________________________|____________| Intestine Large, Rectum | + + + + + + + + + + | 58 | __________________________________________________________________________|____________| Intestine Large, Cecum | + + + + + + + + + + | 60 | __________________________________________________________________________|____________| Intestine Small, Duodenum | + + + + + + + + + + | 60 | __________________________________________________________________________|____________| Intestine Small, Jejunum | + + + + + + + + + + | 60 | __________________________________________________________________________|____________| Intestine Small, Ileum | + + + + + + + + + + | 60 | __________________________________________________________________________|____________| Liver | + + + + + + + + + + | 60 | Basophilic Focus | | 2 | Clear Cell Focus | X | 1 | Eosinophilic Focus | X X X X | 12 | Eosinophilic Focus, Multiple | | 1 | Fatty Change, Diffuse | | 1 2.0| Fatty Change, Focal | | 6 1.3| Fatty Change | | 1 1.0| Fibrosis | | 1 2.0| Inflammation, Focal, Necrotizing | | 1 1.0| Mixed Cell Focus | X X | 7 | Necrosis, Focal | | 2 1.0| Centrilobular, Hypertrophy | | 6 1.0| __________________________________________________________________________|____________| Mesentery | | 2 | Inflammation, Chronic Active | | 1 3.0| __________________________________________________________________________|____________| Pancreas | + + + + + + + + + + | 60 | Duct, Cyst | | 1 | __________________________________________________________________________|____________| Salivary Glands | + + + + + + + + + + | 60 | __________________________________________________________________________|____________| Stomach, Forestomach | + + + + + + + + + + | 60 | __________________________________________________________________________|____________| Stomach, Glandular | + + + + + + + + + + | 60 | __________________________________________________________________________|____________| Tongue | | 2 | Mineralization | | 1 1.0| _____________________________________________________________________________________________________________________| | CARDIOVASCULAR SYSTEM | | | | | | __________________________________________________________________________|____________| Heart | + + + + + + + + + + | 60 | Cardiomyopathy | | 1 1.0| _____________________________________________________________________________________________________________________| | ENDOCRINE SYSTEM | | | | | | __________________________________________________________________________|____________| Adrenal Cortex | + + + + + + + + + + | 58 | Hyperplasia | | 3 2.0| Hypertrophy | | 2 1.0| __________________________________________________________________________________________________________________________________ * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 71 NTP Experiment-Test: 05108-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:51:25 __________________________________________________________________________________________________________________________________ | 7| 7| 6| 7| 7| 7| 7| 7| 7| 7| | | DAY ON TEST | 3| 3| 6| 3| 3| 3| 3| 3| 3| 3| | | | 0| 0| 9| 0| 0| 0| 0| 0| 0| 0| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | B6C3F1 MICE MALE | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| | T | ANIMAL ID | 3| 3| 3| 3| 3| 3| 3| 3| 3| 4| | A | 45.0 | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| | L | MG/KG | 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| | | __________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM - cont | | | | | | __________________________________________________________________________|____________| Adrenal Medulla | M + M + + + + + + + | 55 | __________________________________________________________________________|____________| Islets, Pancreatic | + + + + + + + + + + | 60 | __________________________________________________________________________|____________| Parathyroid Gland | + + + + + + + + M + | 42 | __________________________________________________________________________|____________| Pituitary Gland | + + + + + + + M + + | 56 | Pars Distalis, Hyperplasia | 2 | 2 1.5| __________________________________________________________________________|____________| Thyroid Gland | + + + + + + + + + + | 60 | Follicular Cell, Hyperplasia | 2 1 | 3 1.3| _____________________________________________________________________________________________________________________| | GENERAL BODY SYSTEM | | | | | | None | | | _____________________________________________________________________________________________________________________| | GENITAL SYSTEM | | | | | | __________________________________________________________________________|____________| Epididymis | + + + + + + + + + + | 60 | __________________________________________________________________________|____________| Preputial Gland | + + + | 21 | Dilatation | 2 2 2 | 18 2.1| __________________________________________________________________________|____________| Prostate | + + M + + + + M + + | 55 | __________________________________________________________________________|____________| Seminal Vesicle | + + + + + + + + + + | 60 | __________________________________________________________________________|____________| Testes | + + + + + + + + + + | 60 | _____________________________________________________________________________________________________________________| | HEMATOPOIETIC SYSTEM | | | | | | __________________________________________________________________________|____________| Bone Marrow | + + + + + + + + + + | 60 | __________________________________________________________________________|____________| Lymph Node | | 1 | __________________________________________________________________________|____________| Lymph Node, Mandibular | + + + + + + + + + M | 54 | __________________________________________________________________________|____________| Lymph Node, Mesenteric | + M + + + + + + + + | 56 | __________________________________________________________________________|____________| Spleen | + + + + + + + + + + | 60 | Hematopoietic Cell Proliferation | 3 2 | 3 2.7| __________________________________________________________________________|____________| Thymus | + M M + + + + + M + | 51 | _____________________________________________________________________________________________________________________| | INTEGUMENTARY SYSTEM | | | | | | __________________________________________________________________________|____________| Mammary Gland | M M M M M M M M M M | | __________________________________________________________________________|____________| Skin | + + + + + + + + + + | 60 | Necrosis | 3 2 | 2 2.5| _____________________________________________________________________________________________________________________| | MUSCULOSKELETAL SYSTEM | | | | | | __________________________________________________________________________|____________| Bone | + + + + + + + + + + | 60 | __________________________________________________________________________|____________| Skeletal Muscle | | 1 | _____________________________________________________________________________________________________________________| | NERVOUS SYSTEM | | | | | | __________________________________________________________________________|____________| Brain | + + + + + + + + + + | 60 | __________________________________________________________________________________________________________________________________ * : 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: 05108-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:51:25 __________________________________________________________________________________________________________________________________ | 7| 7| 6| 7| 7| 7| 7| 7| 7| 7| | | DAY ON TEST | 3| 3| 6| 3| 3| 3| 3| 3| 3| 3| | | | 0| 0| 9| 0| 0| 0| 0| 0| 0| 0| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | B6C3F1 MICE MALE | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| | T | ANIMAL ID | 3| 3| 3| 3| 3| 3| 3| 3| 3| 4| | A | 45.0 | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| | L | MG/KG | 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| | | __________________________________________________________________________________________________________________________________ NERVOUS SYSTEM - cont | | | | | | _____________________________________________________________________________________________________________________| | RESPIRATORY SYSTEM | | | | | | __________________________________________________________________________|____________| Lung | + + + + + + + + + + | 60 | Hemorrhage | | 1 2.0| Infiltration Cellular, Histiocyte | 2 | 1 2.0| Alveolar Epithelium, Hyperplasia | | 1 3.0| __________________________________________________________________________|____________| Nose | + + + + + + M M + + | 55 | Inflammation, Acute | | 2 1.0| __________________________________________________________________________|____________| Trachea | + + + + + + + + + + | 60 | _____________________________________________________________________________________________________________________| | SPECIAL SENSES SYSTEM | | | | | | __________________________________________________________________________|____________| Harderian Gland | | 3 | Hyperplasia | | 1 1.0| _____________________________________________________________________________________________________________________| | URINARY SYSTEM | | | | | | __________________________________________________________________________|____________| Kidney | + + + + + + + + + + | 60 | Cyst | | 2 | Nephropathy | 2 | 6 1.8| Renal Tubule, Regeneration | | 3 1.0| __________________________________________________________________________|____________| Urinary Bladder | + + + + + + + + + + | 59 | Calculus Gross Observation | | 1 | Calculus Micro Observation Only | | 2 | __________________________________________________________________________________________________________________________________ * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 73 ------------------------------------------------------------ ---------- END OF REPORT ---------- ------------------------------------------------------------