TDMS Study 05108-01 Pathology Tables
NTP Experiment-Test: 05108-01 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:43:56 Facility: TSI Mason Research Chemical CAS #: 58-33-3 Lock Date: 10/28/91 Cage Range: All Reasons For Removal: All Removal Date Range: All Treatment Groups: Include All Page 1 NTP Experiment-Test: 05108-01 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:43:56 _____________________________________________________________________________________________________________________ | 7| 7| 5| 4| 0| 7| 7| 4| 4| 4| 7| 4| 4| 4| 4| 7| 7| 7| 7| 4| 7| 7| 7| 7| 6| DAY ON TEST | 3| 1| 1| 1| 2| 3| 3| 7| 5| 5| 3| 6| 5| 5| 5| 3| 3| 3| 3| 5| 3| 3| 3| 3| 2| | 6| 7| 3| 2| 3| 6| 6| 3| 0| 0| 4| 2| 1| 0| 0| 7| 7| 7| 7| 1| 6| 6| 6| 5| 9| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| FISCHER 344 RATS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| VEHICLE | 4| 4| 4| 4| 4| 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 8| 8| 8| 8| 8| FEMALE | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| _____________________________________________________________________________________________________________________| ALIMENTARY SYSTEM | | | | __________________________________________________________________________| Esophagus | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Large, Colon | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Large, Rectum | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Large, Cecum | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Small, Duodenum | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Small, Jejunum | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Small, Ileum | + + + + + + + + + + + A + + + + + + + + + + + + +| __________________________________________________________________________| Liver | + + + + + + + + + + + + + + + + + + + + + + + + +| Basophilic Focus | X X X X X X X X X X X X X X X X| Clear Cell Focus | X | Fatty Change, Diffuse | 3 2 | Fatty Change, Focal | 1 2 | Hemorrhage | 2 | Hepatodiaphragmatic Nodule | | Inflammation, Granulomatous | 2 2 | Mixed Cell Focus | | Necrosis | | Pigmentation | 3 2 | __________________________________________________________________________| Mesentery | + | Fat, Mineralization | 1 | Fat, Necrosis | 3 | __________________________________________________________________________| Pancreas | + + + + + + + + + + + + + + + + + + + + + + + + +| Acinus, Atrophy | | __________________________________________________________________________| Salivary Glands | + + + + + + + + + + + + + + + + + + + + + + + + +| Duct, Metaplasia, Squamous | | __________________________________________________________________________| Stomach, Forestomach | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Stomach, Glandular | + + + + + + + + + + + + + + + + + + + + + + + + +| Necrosis | 3 | __________________________________________________________________________| Tongue | + | _____________________________________________________________________________________________________________________| CARDIOVASCULAR SYSTEM | | | | __________________________________________________________________________| Heart | + + + + + + + + + + + + + + + + + + + + + + + + +| Cardiomyopathy | 2 2 2 2 2 2 2 2 2 2 2| _____________________________________________________________________________________________________________________| ENDOCRINE SYSTEM | | | | __________________________________________________________________________| Adrenal Cortex | + + + + + + + + + + + + + + + + + + + + + + + + +| Hyperplasia | 2 | __________________________________________________________________________| Adrenal Medulla | + + + + + + + + + + + + + + + + + + + + + + + + +| Hyperplasia | | __________________________________________________________________________| Islets, Pancreatic | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Parathyroid Gland | + + + + + + M + + + + + + + + + + + + + M + + + +| __________________________________________________________________________| Pituitary Gland | + + + + + + + + + + + + + + + + + + + + + + M + +| Pars Distalis, Angiectasis | 2 2 3 2 2 2 2 2 2| Pars Distalis, Cyst | X | _____________________________________________________________________________________________________________________| Page 2 NTP Experiment-Test: 05108-01 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:43:56 _____________________________________________________________________________________________________________________ | 7| 7| 5| 4| 0| 7| 7| 4| 4| 4| 7| 4| 4| 4| 4| 7| 7| 7| 7| 4| 7| 7| 7| 7| 6| DAY ON TEST | 3| 1| 1| 1| 2| 3| 3| 7| 5| 5| 3| 6| 5| 5| 5| 3| 3| 3| 3| 5| 3| 3| 3| 3| 2| | 6| 7| 3| 2| 3| 6| 6| 3| 0| 0| 4| 2| 1| 0| 0| 7| 7| 7| 7| 1| 6| 6| 6| 5| 9| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| FISCHER 344 RATS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| VEHICLE | 4| 4| 4| 4| 4| 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 8| 8| 8| 8| 8| FEMALE | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| _____________________________________________________________________________________________________________________| ENDOCRINE SYSTEM - cont | | | | Pars Distalis, Hyperplasia | 2 2 1 2 1 2 2 2 2 | Pars Nervosa, Angiectasis | | Pars Nervosa, Cyst | | __________________________________________________________________________| Thyroid Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| C-Cell, Hyperplasia | 2 2 1 | Follicle, Cyst | X | _____________________________________________________________________________________________________________________| GENERAL BODY SYSTEM | | | | None | | _____________________________________________________________________________________________________________________| GENITAL SYSTEM | | | | __________________________________________________________________________| Clitoral Gland | M + + + + + + + + + + + + + + + + + + + + + + + +| Hyperplasia | | Inflammation, Acute | | __________________________________________________________________________| Ovary | + + + + + + + + + + + + + + + + + + + + + + + + +| Cyst | X X| __________________________________________________________________________| Uterus | + M + + + + + + + + + + + + + + + + + + + + + + +| Hemorrhage | | Inflammation, Acute | 2 | Metaplasia, Osseous | | Cervix, Fibrosis | | Cervix, Inflammation, Acute | | Cervix, Pigmentation | | _____________________________________________________________________________________________________________________| HEMATOPOIETIC SYSTEM | | | | __________________________________________________________________________| Blood | + | __________________________________________________________________________| Bone Marrow | + + + + + + + M + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Lymph Node | + + + + + +| Pancreatic, Angiectasis | | Pancreatic, Infiltration Cellular, | | Histiocyte | 2 | __________________________________________________________________________| Lymph Node, Mandibular | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Lymph Node, Mesenteric | + + + + + + + + + + + + + + + + + + + + + + + + +| Angiectasis | | Infiltration Cellular, Histiocyte | 1 | __________________________________________________________________________| Spleen | + + + + + + + + + + + + + + + + + + + + + + + + +| Fibrosis | 3 | Hematopoietic Cell Proliferation | 3 2 | Infarct | 3| Infiltration Cellular, Histiocyte | 3 | __________________________________________________________________________| Thymus | + + + + + + + + + + + + + + + M + M + + + + + + +| Hemorrhage | 2 | _____________________________________________________________________________________________________________________| INTEGUMENTARY SYSTEM | | | | _____________________________________________________________________________________________________________________| Page 3 NTP Experiment-Test: 05108-01 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:43:56 _____________________________________________________________________________________________________________________ | 7| 7| 5| 4| 0| 7| 7| 4| 4| 4| 7| 4| 4| 4| 4| 7| 7| 7| 7| 4| 7| 7| 7| 7| 6| DAY ON TEST | 3| 1| 1| 1| 2| 3| 3| 7| 5| 5| 3| 6| 5| 5| 5| 3| 3| 3| 3| 5| 3| 3| 3| 3| 2| | 6| 7| 3| 2| 3| 6| 6| 3| 0| 0| 4| 2| 1| 0| 0| 7| 7| 7| 7| 1| 6| 6| 6| 5| 9| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| FISCHER 344 RATS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| VEHICLE | 4| 4| 4| 4| 4| 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 8| 8| 8| 8| 8| FEMALE | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| _____________________________________________________________________________________________________________________| INTEGUMENTARY SYSTEM - cont | | | | __________________________________________________________________________| Mammary Gland | + + + + + + + + M + + + + M + + + + + + + + + + +| Galactocele | X X X X X X| __________________________________________________________________________| Skin | + + + + + + + + + + + + + + + + + + + + + + + + +| Cyst Epithelial Inclusion | | _____________________________________________________________________________________________________________________| MUSCULOSKELETAL SYSTEM | | | | __________________________________________________________________________| Bone | + + + + + + + M + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| NERVOUS SYSTEM | | | | __________________________________________________________________________| Brain | + + + + + + + + + + + + + + + + + + + + + + + + +| Hemorrhage | | _____________________________________________________________________________________________________________________| RESPIRATORY SYSTEM | | | | __________________________________________________________________________| Lung | + + + + + + + + + + + + + + + + + + + + + + + + +| Hemorrhage | 3 | Alveolar Epithelium, Hyperplasia | 1 1 | __________________________________________________________________________| Nose | + + + + + + + + + + + + + + + + + + + + + + M + +| Fungus | | Inflammation, Acute | 4 | __________________________________________________________________________| Trachea | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| SPECIAL SENSES SYSTEM | | | | __________________________________________________________________________| Eye | + | Lens, Cataract | 2 | _____________________________________________________________________________________________________________________| URINARY SYSTEM | | | | __________________________________________________________________________| Kidney | + + + + + + + + + + + + + + + + + + + + + + + + +| Nephropathy | 2 1 1 1 1 1 1 1 1 1 1 1 2 2 2 1 2 1 1 1| Pigmentation | 3 | Artery, Inflammation, Chronic Active | 2 | Cortex, Mineralization | 1 1 1 1 1 | __________________________________________________________________________| Urinary Bladder | + M + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| Page 4 NTP Experiment-Test: 05108-01 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:43:56 _____________________________________________________________________________________________________________________ | 7| 6| 5| 4| 4| 7| 7| 7| 7| 7| 7| 7| 7| 6| 4| 7| 7| 6| 6| 5| 7| 7| 7| 7| 7| DAY ON TEST | 3| 7| 4| 7| 5| 3| 3| 3| 3| 2| 3| 3| 3| 7| 1| 3| 3| 4| 3| 4| 3| 3| 3| 3| 3| | 7| 4| 7| 7| 0| 7| 7| 7| 5| 2| 7| 7| 7| 3| 3| 7| 7| 5| 6| 6| 7| 7| 7| 7| 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| FISCHER 344 RATS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| VEHICLE | 9| 9| 9| 9| 9| 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 3| 3| 3| 3| 3| FEMALE | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| _____________________________________________________________________________________________________________________| ALIMENTARY SYSTEM | | | | __________________________________________________________________________| Esophagus | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Large, Colon | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Large, Rectum | + A + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Large, Cecum | + A + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Small, Duodenum | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Small, Jejunum | + A + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Small, Ileum | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Liver | + + + + + + + + + + + + + + + + + + + + + + + + +| Basophilic Focus | X X X X X X X X X X| Clear Cell Focus | X | Fatty Change, Diffuse | | Fatty Change, Focal | 1 1 | Hemorrhage | | Hepatodiaphragmatic Nodule | | Inflammation, Granulomatous | 1 1 2 1 | Mixed Cell Focus | X X | Necrosis | | Pigmentation | | __________________________________________________________________________| Mesentery | | Fat, Mineralization | | Fat, Necrosis | | __________________________________________________________________________| Pancreas | + + + + + + + + + + + + + + + + + + + + + + + + +| Acinus, Atrophy | 3 | __________________________________________________________________________| Salivary Glands | + + + + + + + + + + + + + + + + + + + + + + + + +| Duct, Metaplasia, Squamous | | __________________________________________________________________________| Stomach, Forestomach | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Stomach, Glandular | + + + + + + + + + + + + + + + + + + + + + + + + +| Necrosis | | __________________________________________________________________________| Tongue | | _____________________________________________________________________________________________________________________| CARDIOVASCULAR SYSTEM | | | | __________________________________________________________________________| Heart | + + + + + + + + + + + + + + + + + + + + + + + + +| Cardiomyopathy | 2 2 1 2 1 2 2 2 2 2 2| _____________________________________________________________________________________________________________________| ENDOCRINE SYSTEM | | | | __________________________________________________________________________| Adrenal Cortex | + + + + + + + + + + + + + + + + + + + + + + + + +| Hyperplasia | | __________________________________________________________________________| Adrenal Medulla | + + + + + + + + + + + + + + + + + + + + + + + + +| Hyperplasia | 2 | __________________________________________________________________________| Islets, Pancreatic | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Parathyroid Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Pituitary Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| Pars Distalis, Angiectasis | 2 2 2 2 2 2 2 2 2 2 2| Pars Distalis, Cyst | X X X | _____________________________________________________________________________________________________________________| Page 5 NTP Experiment-Test: 05108-01 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:43:56 _____________________________________________________________________________________________________________________ | 7| 6| 5| 4| 4| 7| 7| 7| 7| 7| 7| 7| 7| 6| 4| 7| 7| 6| 6| 5| 7| 7| 7| 7| 7| DAY ON TEST | 3| 7| 4| 7| 5| 3| 3| 3| 3| 2| 3| 3| 3| 7| 1| 3| 3| 4| 3| 4| 3| 3| 3| 3| 3| | 7| 4| 7| 7| 0| 7| 7| 7| 5| 2| 7| 7| 7| 3| 3| 7| 7| 5| 6| 6| 7| 7| 7| 7| 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| FISCHER 344 RATS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| VEHICLE | 9| 9| 9| 9| 9| 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 3| 3| 3| 3| 3| FEMALE | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| _____________________________________________________________________________________________________________________| ENDOCRINE SYSTEM - cont | | | | Pars Distalis, Hyperplasia | 3 3 1 3 2 2 2 1 2 | Pars Nervosa, Angiectasis | 2 2 | Pars Nervosa, Cyst | X | __________________________________________________________________________| Thyroid Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| C-Cell, Hyperplasia | 2 2 1 2 | Follicle, Cyst | X | _____________________________________________________________________________________________________________________| GENERAL BODY SYSTEM | | | | None | | _____________________________________________________________________________________________________________________| GENITAL SYSTEM | | | | __________________________________________________________________________| Clitoral Gland | M + + + + + + + + + + + + + + + + + + + + + + +| Hyperplasia | 2 | Inflammation, Acute | 2 | __________________________________________________________________________| Ovary | + + + + + + + + + + + + + + + + + + + + + + + + +| Cyst | X | __________________________________________________________________________| Uterus | + + + + + + + + + + + + + + + + + + + + + + + + +| Hemorrhage | | Inflammation, Acute | | Metaplasia, Osseous | 2 | Cervix, Fibrosis | 2 | Cervix, Inflammation, Acute | 2 | Cervix, Pigmentation | 2 | _____________________________________________________________________________________________________________________| HEMATOPOIETIC SYSTEM | | | | __________________________________________________________________________| Blood | + + | __________________________________________________________________________| Bone Marrow | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Lymph Node | + + + + + | Pancreatic, Angiectasis | 2 | Pancreatic, Infiltration Cellular, | | Histiocyte | 2 | __________________________________________________________________________| Lymph Node, Mandibular | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Lymph Node, Mesenteric | + + + + + + + + + + + + + + + + + + + + + + + + +| Angiectasis | 2 | Infiltration Cellular, Histiocyte | 2 | __________________________________________________________________________| Spleen | + + + + + + + + + + + + + + + + + + + + + + + + +| Fibrosis | 2 | Hematopoietic Cell Proliferation | 2 | Infarct | | Infiltration Cellular, Histiocyte | 3 | __________________________________________________________________________| Thymus | + + + + + + + M + + + + + + + M + + + + + + + + +| Hemorrhage | | _____________________________________________________________________________________________________________________| INTEGUMENTARY SYSTEM | | | | _____________________________________________________________________________________________________________________| Page 6 NTP Experiment-Test: 05108-01 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:43:56 _____________________________________________________________________________________________________________________ | 7| 6| 5| 4| 4| 7| 7| 7| 7| 7| 7| 7| 7| 6| 4| 7| 7| 6| 6| 5| 7| 7| 7| 7| 7| DAY ON TEST | 3| 7| 4| 7| 5| 3| 3| 3| 3| 2| 3| 3| 3| 7| 1| 3| 3| 4| 3| 4| 3| 3| 3| 3| 3| | 7| 4| 7| 7| 0| 7| 7| 7| 5| 2| 7| 7| 7| 3| 3| 7| 7| 5| 6| 6| 7| 7| 7| 7| 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| FISCHER 344 RATS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| VEHICLE | 9| 9| 9| 9| 9| 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 3| 3| 3| 3| 3| FEMALE | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| _____________________________________________________________________________________________________________________| INTEGUMENTARY SYSTEM - cont | | | | __________________________________________________________________________| Mammary Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| Galactocele | X X X X | __________________________________________________________________________| Skin | + + + + + + + + + + + + + + + + + + + + + + + + +| Cyst Epithelial Inclusion | X | _____________________________________________________________________________________________________________________| MUSCULOSKELETAL SYSTEM | | | | __________________________________________________________________________| Bone | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| NERVOUS SYSTEM | | | | __________________________________________________________________________| Brain | + + + + + + + + + + + + + + + + + + + + + + + + +| Hemorrhage | | _____________________________________________________________________________________________________________________| RESPIRATORY SYSTEM | | | | __________________________________________________________________________| Lung | + + + + + + + + + + + + + + + + + + + + + + + + +| Hemorrhage | | Alveolar Epithelium, Hyperplasia | 3 | __________________________________________________________________________| Nose | + + + + + + + + + + + + + + + + + + + + + + + + +| Fungus | 3 | Inflammation, Acute | 3 | __________________________________________________________________________| Trachea | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| SPECIAL SENSES SYSTEM | | | | __________________________________________________________________________| Eye | | Lens, Cataract | | _____________________________________________________________________________________________________________________| URINARY SYSTEM | | | | __________________________________________________________________________| Kidney | + + + + + + + + + + + + + + + + + + + + + + + + +| Nephropathy | 2 1 1 1 1 2 1 1 2 2 1 2 2 2 2 2 1 1 1 1 1 1 2| Pigmentation | | Artery, Inflammation, Chronic Active | | Cortex, Mineralization | 1 | __________________________________________________________________________| Urinary Bladder | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| Page 7 NTP Experiment-Test: 05108-01 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:43:56 __________________________________________________________________________________________________________________________________ | 7| 7| 7| 7| 5| 7| 6| 4| 4| 4| | | DAY ON TEST | 3| 3| 3| 2| 7| 3| 8| 5| 5| 5| | | | 7| 7| 7| 9| 4| 7| 4| 1| 0| 0| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | FISCHER 344 RATS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| | A | VEHICLE | 4| 4| 4| 4| 4| 5| 5| 5| 5| 5| | L | FEMALE | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| | | __________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM | | | | | | __________________________________________________________________________|____________| Esophagus | + + + + + + + + + + | 60 | __________________________________________________________________________|____________| Intestine Large, Colon | + + + + + + A + + + | 59 | __________________________________________________________________________|____________| Intestine Large, Rectum | + + + + + + A + + + | 58 | __________________________________________________________________________|____________| Intestine Large, Cecum | + + + + A + A + + + | 57 | __________________________________________________________________________|____________| Intestine Small, Duodenum | + + + + + + A + + + | 59 | __________________________________________________________________________|____________| Intestine Small, Jejunum | + + + + + + A + + + | 58 | __________________________________________________________________________|____________| Intestine Small, Ileum | + + + + + + A + + + | 58 | __________________________________________________________________________|____________| Liver | + + + + + + + + + + | 60 | Basophilic Focus | X X | 28 | Clear Cell Focus | | 2 | Fatty Change, Diffuse | | 2 2.5| Fatty Change, Focal | 2 | 5 1.4| Hemorrhage | | 1 2.0| Hepatodiaphragmatic Nodule | X | 1 | Inflammation, Granulomatous | | 6 1.5| Mixed Cell Focus | X | 3 | Necrosis | 2 | 1 2.0| Pigmentation | | 2 2.5| __________________________________________________________________________|____________| Mesentery | | 1 | Fat, Mineralization | | 1 1.0| Fat, Necrosis | | 1 3.0| __________________________________________________________________________|____________| Pancreas | + + + + + + + + + + | 60 | Acinus, Atrophy | | 1 3.0| __________________________________________________________________________|____________| Salivary Glands | + + + + + + + + + + | 60 | Duct, Metaplasia, Squamous | 1 | 1 1.0| __________________________________________________________________________|____________| Stomach, Forestomach | + + + M + + + + + + | 59 | __________________________________________________________________________|____________| Stomach, Glandular | + + + + + + + + + + | 60 | Necrosis | 2 | 2 2.5| __________________________________________________________________________|____________| Tongue | | 1 | _____________________________________________________________________________________________________________________| | CARDIOVASCULAR SYSTEM | | | | | | __________________________________________________________________________|____________| Heart | + + + + + + + + + + | 60 | Cardiomyopathy | 2 2 2 2 2 2 2 | 29 1.9| _____________________________________________________________________________________________________________________| | ENDOCRINE SYSTEM | | | | | | __________________________________________________________________________|____________| Adrenal Cortex | + + + + + + + + + + | 60 | Hyperplasia | | 1 2.0| __________________________________________________________________________|____________| Adrenal Medulla | + + + + + + + + + + | 60 | Hyperplasia | 1 | 2 1.5| __________________________________________________________________________________________________________________________________ * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 8 NTP Experiment-Test: 05108-01 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:43:56 __________________________________________________________________________________________________________________________________ | 7| 7| 7| 7| 5| 7| 6| 4| 4| 4| | | DAY ON TEST | 3| 3| 3| 2| 7| 3| 8| 5| 5| 5| | | | 7| 7| 7| 9| 4| 7| 4| 1| 0| 0| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | FISCHER 344 RATS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| | A | VEHICLE | 4| 4| 4| 4| 4| 5| 5| 5| 5| 5| | L | FEMALE | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| | | __________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM - cont | | | | | | __________________________________________________________________________|____________| Islets, Pancreatic | + + + + + + + + + + | 60 | __________________________________________________________________________|____________| Parathyroid Gland | + + + + + + + + + + | 58 | __________________________________________________________________________|____________| Pituitary Gland | + + + + + + + + + + | 59 | Pars Distalis, Angiectasis | 2 2 2 2 2 2 1 | 27 2.0| Pars Distalis, Cyst | X X X | 7 | Pars Distalis, Hyperplasia | 2 2 2 | 21 2.0| Pars Nervosa, Angiectasis | 2 | 3 2.0| Pars Nervosa, Cyst | | 1 | __________________________________________________________________________|____________| Thyroid Gland | + + + + + + A + + + | 59 | C-Cell, Hyperplasia | 1 2 1 | 10 1.6| Follicle, Cyst | | 2 | _____________________________________________________________________________________________________________________| | GENERAL BODY SYSTEM | | | | | | None | | | _____________________________________________________________________________________________________________________| | GENITAL SYSTEM | | | | | | __________________________________________________________________________|____________| Clitoral Gland | + + + + + M + + + + | 56 | Hyperplasia | | 1 2.0| Inflammation, Acute | | 1 2.0| __________________________________________________________________________|____________| Ovary | + + + + + + + + + + | 60 | Cyst | | 3 | __________________________________________________________________________|____________| Uterus | + + + + + + + + + + | 59 | Hemorrhage | 4 | 1 4.0| Inflammation, Acute | | 1 2.0| Metaplasia, Osseous | | 1 2.0| Cervix, Fibrosis | | 1 2.0| Cervix, Inflammation, Acute | | 1 2.0| Cervix, Pigmentation | | 1 2.0| _____________________________________________________________________________________________________________________| | HEMATOPOIETIC SYSTEM | | | | | | __________________________________________________________________________|____________| Blood | + + | 5 | __________________________________________________________________________|____________| Bone Marrow | + + + + + + + + + + | 59 | __________________________________________________________________________|____________| Lymph Node | + | 12 | Pancreatic, Angiectasis | | 1 2.0| Pancreatic, Infiltration Cellular, | | | Histiocyte | | 2 2.0| __________________________________________________________________________|____________| Lymph Node, Mandibular | + + + + + + + + + + | 60 | __________________________________________________________________________|____________| Lymph Node, Mesenteric | + + + + + + + + + + | 60 | Angiectasis | | 1 2.0| __________________________________________________________________________________________________________________________________ * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 9 NTP Experiment-Test: 05108-01 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:43:56 __________________________________________________________________________________________________________________________________ | 7| 7| 7| 7| 5| 7| 6| 4| 4| 4| | | DAY ON TEST | 3| 3| 3| 2| 7| 3| 8| 5| 5| 5| | | | 7| 7| 7| 9| 4| 7| 4| 1| 0| 0| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | FISCHER 344 RATS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| | A | VEHICLE | 4| 4| 4| 4| 4| 5| 5| 5| 5| 5| | L | FEMALE | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| | | __________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - cont | | | | | | Infiltration Cellular, Histiocyte | | 2 1.5| __________________________________________________________________________|____________| Spleen | + + + + + + + + + + | 60 | Fibrosis | | 2 2.5| Hematopoietic Cell Proliferation | | 3 2.3| Infarct | | 1 3.0| Infiltration Cellular, Histiocyte | | 2 3.0| __________________________________________________________________________|____________| Thymus | + M + + + + + + + + | 55 | Hemorrhage | | 1 2.0| _____________________________________________________________________________________________________________________| | INTEGUMENTARY SYSTEM | | | | | | __________________________________________________________________________|____________| Mammary Gland | + + + + + + + + + + | 58 | Galactocele | X X X X | 14 | __________________________________________________________________________|____________| Skin | + + + + + + + + + + | 60 | Cyst Epithelial Inclusion | X | 2 | _____________________________________________________________________________________________________________________| | MUSCULOSKELETAL SYSTEM | | | | | | __________________________________________________________________________|____________| Bone | + + + + + + + + + + | 59 | _____________________________________________________________________________________________________________________| | NERVOUS SYSTEM | | | | | | __________________________________________________________________________|____________| Brain | + + + + + + + + + + | 60 | Hemorrhage | 3 | 1 3.0| _____________________________________________________________________________________________________________________| | RESPIRATORY SYSTEM | | | | | | __________________________________________________________________________|____________| Lung | + + + + + + + + + + | 60 | Hemorrhage | | 1 3.0| Alveolar Epithelium, Hyperplasia | 2 | 4 1.8| __________________________________________________________________________|____________| Nose | + + + + + + + + + + | 59 | Fungus | | 1 3.0| Inflammation, Acute | | 2 3.5| __________________________________________________________________________|____________| Trachea | + + + + + + + + + + | 60 | _____________________________________________________________________________________________________________________| | SPECIAL SENSES SYSTEM | | | | | | __________________________________________________________________________|____________| Eye | | 1 | Lens, Cataract | | 1 2.0| _____________________________________________________________________________________________________________________| | URINARY SYSTEM | | | | | | __________________________________________________________________________|____________| Kidney | + + + + + + + + + + | 60 | Nephropathy | 1 1 2 1 1 2 1 1 1 | 52 1.3| Pigmentation | | 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 10 NTP Experiment-Test: 05108-01 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:43:56 __________________________________________________________________________________________________________________________________ | 7| 7| 7| 7| 5| 7| 6| 4| 4| 4| | | DAY ON TEST | 3| 3| 3| 2| 7| 3| 8| 5| 5| 5| | | | 7| 7| 7| 9| 4| 7| 4| 1| 0| 0| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | FISCHER 344 RATS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| | A | VEHICLE | 4| 4| 4| 4| 4| 5| 5| 5| 5| 5| | L | FEMALE | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| | | __________________________________________________________________________________________________________________________________ URINARY SYSTEM - cont | | | | | | Artery, Inflammation, Chronic Active | | 1 2.0| Cortex, Mineralization | 1 1 | 8 1.0| __________________________________________________________________________|____________| Urinary Bladder | + + + + + + + + + + | 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 11 NTP Experiment-Test: 05108-01 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:43:56 _____________________________________________________________________________________________________________________ | 7| 6| 5| 4| 4| 7| 7| 7| 7| 4| 7| 7| 7| 7| 6| 7| 7| 7| 7| 6| 7| 7| 6| 4| 4| DAY ON TEST | 3| 3| 9| 5| 5| 3| 3| 3| 3| 5| 3| 3| 3| 3| 1| 3| 3| 3| 3| 7| 3| 3| 2| 5| 5| | 6| 9| 7| 1| 0| 6| 6| 6| 6| 1| 6| 6| 6| 6| 6| 6| 6| 6| 5| 6| 6| 6| 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| 0| 0| FISCHER 344 RATS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 8.3 | 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 0| 0| 0| 0| 0| MG/KG | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| _____________________________________________________________________________________________________________________| ALIMENTARY SYSTEM | | | | __________________________________________________________________________| Esophagus | + + + + + + + + + + + + + + + + + + + + + + + + +| Erosion | 3 | Hyperkeratosis | | Inflammation, Acute | 2 | __________________________________________________________________________| 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 | + + + + + + + + + + + + + + + + + + + + + + + + +| Basophilic Focus | X X X X X X X X X X X X X| Hepatodiaphragmatic Nodule | X X | Inflammation, Granulomatous | | Mixed Cell Focus | | Bile Duct, Hyperplasia | | __________________________________________________________________________| Mesentery | + + + | Fat, Necrosis | 3 3 | __________________________________________________________________________| Pancreas | + + + + + + + + + + + + + + + + + + + + + + + + +| Acinus, Hyperplasia | | __________________________________________________________________________| Salivary Glands | + + + + + + + + + + + + + + + + + + + + + + + + +| Atrophy | | __________________________________________________________________________| Stomach, Forestomach | + + + + + + + + + + + + + + + + + + + + + + + + +| Hyperkeratosis | 2 | Hyperplasia, Basal Cell | 1 1 | __________________________________________________________________________| Stomach, Glandular | + A + + + + + + + + + + + + + + + + + + + + + + +| Hyperplasia | | __________________________________________________________________________| Tongue | | _____________________________________________________________________________________________________________________| CARDIOVASCULAR SYSTEM | | | | __________________________________________________________________________| Heart | + + + + + + + + + + + + + + + + + + + + + + + + +| Cardiomyopathy | 2 2 2 2 2 2 1 2 2 2 2 2 | Mineralization | | _____________________________________________________________________________________________________________________| ENDOCRINE SYSTEM | | | | __________________________________________________________________________| Adrenal Cortex | + + + + + + + + + + + + + + + + + + + + + + + + +| Accessory Adrenal Cortical Nodule | | Hemorrhage | | Hyperplasia | 2 | __________________________________________________________________________| Adrenal Medulla | + + + + + + + + + + + + + + + + + + + + + + + + +| Hyperplasia | 1 1 | __________________________________________________________________________| Islets, Pancreatic | + + + + + + + + + + + + + + + + + + + + + + + + +| Hyperplasia | 1 | __________________________________________________________________________| Parathyroid Gland | M + + + + + + + + + + + + + + M + + + + + + + + +| _____________________________________________________________________________________________________________________| Page 12 NTP Experiment-Test: 05108-01 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:43:56 _____________________________________________________________________________________________________________________ | 7| 6| 5| 4| 4| 7| 7| 7| 7| 4| 7| 7| 7| 7| 6| 7| 7| 7| 7| 6| 7| 7| 6| 4| 4| DAY ON TEST | 3| 3| 9| 5| 5| 3| 3| 3| 3| 5| 3| 3| 3| 3| 1| 3| 3| 3| 3| 7| 3| 3| 2| 5| 5| | 6| 9| 7| 1| 0| 6| 6| 6| 6| 1| 6| 6| 6| 6| 6| 6| 6| 6| 5| 6| 6| 6| 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| 0| 0| FISCHER 344 RATS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 8.3 | 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 0| 0| 0| 0| 0| MG/KG | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| _____________________________________________________________________________________________________________________| ENDOCRINE SYSTEM - cont | | | | __________________________________________________________________________| Pituitary Gland | + M + + + + + + + + + + + + + + + + + + + + + + +| Pars Distalis, Angiectasis | 3 2 2 2 2 3 2 2 2 2 2 1 2 | Pars Distalis, Cyst | X X X X | Pars Distalis, Hyperplasia | 2 2 2 3 2 3 2 2 2| Pars Intermedia, Hyperplasia | | __________________________________________________________________________| Thyroid Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| C-Cell, Hyperplasia | 1 1 | _____________________________________________________________________________________________________________________| GENERAL BODY SYSTEM | | | | None | | _____________________________________________________________________________________________________________________| GENITAL SYSTEM | | | | __________________________________________________________________________| Clitoral Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| Necrosis | 3 2 | __________________________________________________________________________| Ovary | + + + + + + + + + + + + + + + + + + + + + + + + +| Cyst | X | __________________________________________________________________________| Uterus | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Vagina | + | _____________________________________________________________________________________________________________________| HEMATOPOIETIC SYSTEM | | | | __________________________________________________________________________| Blood | + | __________________________________________________________________________| Bone Marrow | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Lymph Node | + + | __________________________________________________________________________| Lymph Node, Mandibular | + + + + + + + + + + + + + + + + + + + + + + + + +| Hemorrhage | | __________________________________________________________________________| Lymph Node, Mesenteric | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Spleen | + + + + + + + + + + + + + + + + + + + + + + + + +| Fibrosis | 2 | Hemorrhage | 2 | __________________________________________________________________________| Thymus | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| INTEGUMENTARY SYSTEM | | | | __________________________________________________________________________| Mammary Gland | + M + M M + + + + + + + + + + + + + + M + + + + +| Galactocele | X | __________________________________________________________________________| Skin | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| MUSCULOSKELETAL SYSTEM | | | | __________________________________________________________________________| Bone | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| NERVOUS SYSTEM | | | | __________________________________________________________________________| Brain | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| RESPIRATORY SYSTEM | | | | __________________________________________________________________________| Lung | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| Page 13 NTP Experiment-Test: 05108-01 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:43:56 _____________________________________________________________________________________________________________________ | 7| 6| 5| 4| 4| 7| 7| 7| 7| 4| 7| 7| 7| 7| 6| 7| 7| 7| 7| 6| 7| 7| 6| 4| 4| DAY ON TEST | 3| 3| 9| 5| 5| 3| 3| 3| 3| 5| 3| 3| 3| 3| 1| 3| 3| 3| 3| 7| 3| 3| 2| 5| 5| | 6| 9| 7| 1| 0| 6| 6| 6| 6| 1| 6| 6| 6| 6| 6| 6| 6| 6| 5| 6| 6| 6| 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| 0| 0| FISCHER 344 RATS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 8.3 | 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 0| 0| 0| 0| 0| MG/KG | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| _____________________________________________________________________________________________________________________| RESPIRATORY SYSTEM - cont | | | | Edema | | Infiltration Cellular, Histiocyte | | Alveolar Epithelium, Hyperplasia | 2 2 | __________________________________________________________________________| Nose | + + + + + + + + + + + + + + + + + + + + + + + + +| Fungus | | Inflammation, Acute | 2 | __________________________________________________________________________| Trachea | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| SPECIAL SENSES SYSTEM | | | | __________________________________________________________________________| Eye | + | Lens, Cataract | 2 | _____________________________________________________________________________________________________________________| URINARY SYSTEM | | | | __________________________________________________________________________| Kidney | + + + + + + + + + + + + + + + + + + + + + + + + +| Mineralization | | Nephropathy | 1 1 1 2 2 1 2 1 1 2 3 2 3 1 1 2 2 2 4 1 1| Cortex, Mineralization | 1 1| Pelvis, Inflammation, Chronic Active | | __________________________________________________________________________| Urinary Bladder | + A + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| Page 14 NTP Experiment-Test: 05108-01 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:43:56 _____________________________________________________________________________________________________________________ | 7| 7| 7| 4| 4| 7| 7| 5| 5| 5| 7| 7| 6| 5| 4| 7| 7| 6| 7| 7| 7| 7| 7| 6| 4| DAY ON TEST | 3| 3| 3| 7| 5| 3| 3| 9| 9| 9| 3| 3| 3| 6| 5| 1| 3| 3| 3| 3| 3| 3| 3| 5| 5| | 6| 6| 6| 9| 0| 5| 5| 7| 7| 1| 6| 6| 2| 6| 1| 7| 5| 2| 6| 6| 6| 6| 4| 7| 1| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| FISCHER 344 RATS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 8.3 | 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 5| 5| 5| 5| 5| MG/KG | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| _____________________________________________________________________________________________________________________| ALIMENTARY SYSTEM | | | | __________________________________________________________________________| Esophagus | + + + + + + + + M + + + + + + + + + + + + + + + +| Erosion | | Hyperkeratosis | 3 | Inflammation, Acute | | __________________________________________________________________________| Intestine Large, Colon | + + + + + + + + + A + + + A + + + + + + + + + + +| __________________________________________________________________________| Intestine Large, Rectum | + + + + + + + + + A + + + A + + + + + + + + + + +| __________________________________________________________________________| Intestine Large, Cecum | + + + + + + + + + A + + + A + + + + + + + + + + +| __________________________________________________________________________| Intestine Small, Duodenum | + + + + + + + + + A + + + A + + + + + + + + + + +| __________________________________________________________________________| Intestine Small, Jejunum | + + + + + + + + + A + + + A + + + + + + + + + + +| __________________________________________________________________________| Intestine Small, Ileum | + + + + + + + + + A + + + A + + + + + + + + + + +| __________________________________________________________________________| Liver | + + + + + + + + + + + + + A + + + + + + + + + + +| Basophilic Focus | X X X X X X X X X X X X X X X| Hepatodiaphragmatic Nodule | X X X | Inflammation, Granulomatous | 1 | Mixed Cell Focus | X | Bile Duct, Hyperplasia | 1 | __________________________________________________________________________| Mesentery | | Fat, Necrosis | | __________________________________________________________________________| Pancreas | + + + + + + + + + + + + + A + + + + + + + + + + +| Acinus, Hyperplasia | | __________________________________________________________________________| Salivary Glands | + + + + + + + + + + + + + A + + + + + + + + + + +| Atrophy | 2 | __________________________________________________________________________| Stomach, Forestomach | + + + + + + + + + + + + + A + + + + + + + + + + +| Hyperkeratosis | 3 | Hyperplasia, Basal Cell | 2 | __________________________________________________________________________| Stomach, Glandular | + + + + + + + + + + + + + A + + + + + + + + + + +| Hyperplasia | 2 | __________________________________________________________________________| Tongue | | _____________________________________________________________________________________________________________________| CARDIOVASCULAR SYSTEM | | | | __________________________________________________________________________| Heart | + + + + + + + + + + + + + + + + + + + + + + + + +| Cardiomyopathy | 2 2 2 2 2 1 2 2 2 2 2 1 2| Mineralization | 1 | _____________________________________________________________________________________________________________________| ENDOCRINE SYSTEM | | | | __________________________________________________________________________| Adrenal Cortex | + + + + + + + + + + + + + A + + + + + + + + + + +| Accessory Adrenal Cortical Nodule | X | Hemorrhage | 3 | Hyperplasia | | __________________________________________________________________________| Adrenal Medulla | + + + + + + + + + + + + + A + + + + + + + + + + +| Hyperplasia | 2 | __________________________________________________________________________| Islets, Pancreatic | + + + + + + + + + + + + + A + + + + + + + + + + +| Hyperplasia | | __________________________________________________________________________| Parathyroid Gland | + + M + + + + + + + + + + + M + + + + + + + + + +| _____________________________________________________________________________________________________________________| Page 15 NTP Experiment-Test: 05108-01 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:43:56 _____________________________________________________________________________________________________________________ | 7| 7| 7| 4| 4| 7| 7| 5| 5| 5| 7| 7| 6| 5| 4| 7| 7| 6| 7| 7| 7| 7| 7| 6| 4| DAY ON TEST | 3| 3| 3| 7| 5| 3| 3| 9| 9| 9| 3| 3| 3| 6| 5| 1| 3| 3| 3| 3| 3| 3| 3| 5| 5| | 6| 6| 6| 9| 0| 5| 5| 7| 7| 1| 6| 6| 2| 6| 1| 7| 5| 2| 6| 6| 6| 6| 4| 7| 1| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| FISCHER 344 RATS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 8.3 | 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 5| 5| 5| 5| 5| MG/KG | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| _____________________________________________________________________________________________________________________| ENDOCRINE SYSTEM - cont | | | | __________________________________________________________________________| Pituitary Gland | + + + + + + + + + + + + + A + + + + + + + + + + +| Pars Distalis, Angiectasis | 1 2 2 3 2 2 1 2 | Pars Distalis, Cyst | X X | Pars Distalis, Hyperplasia | 3 2 2 2 2 2 2 | Pars Intermedia, Hyperplasia | 2 | __________________________________________________________________________| Thyroid Gland | + + + + + + + + + + + + + A + + + + + + + + + + +| C-Cell, Hyperplasia | 1 | _____________________________________________________________________________________________________________________| GENERAL BODY SYSTEM | | | | None | | _____________________________________________________________________________________________________________________| GENITAL SYSTEM | | | | __________________________________________________________________________| Clitoral Gland | + + + + + M + + + + M + + A + + + + + + + + M + +| Necrosis | | __________________________________________________________________________| Ovary | + + + + + + + + + + + + + A + + + + + + + + + + +| Cyst | | __________________________________________________________________________| Uterus | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Vagina | | _____________________________________________________________________________________________________________________| HEMATOPOIETIC SYSTEM | | | | __________________________________________________________________________| Blood | + + + | __________________________________________________________________________| Bone Marrow | + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Lymph Node | + + | __________________________________________________________________________| Lymph Node, Mandibular | + + + + + + + + + + + + + A + + + + + + + + + + +| Hemorrhage | 2 | __________________________________________________________________________| Lymph Node, Mesenteric | + + + + + + + + + + + + + A + + + + + + + + + + +| __________________________________________________________________________| Spleen | + + + + + + + + + + + + + A + + + + + + + + + + +| Fibrosis | 3 | Hemorrhage | | __________________________________________________________________________| Thymus | + + + + + M + + + + + + + A + + + + + + + + + + +| _____________________________________________________________________________________________________________________| INTEGUMENTARY SYSTEM | | | | __________________________________________________________________________| Mammary Gland | M + + + + + + + + + + + + A + + + + + + + + + + +| Galactocele | X | __________________________________________________________________________| Skin | + + + + + + M + + + + + + A + + + + + + + + + + +| _____________________________________________________________________________________________________________________| MUSCULOSKELETAL SYSTEM | | | | __________________________________________________________________________| Bone | + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| NERVOUS SYSTEM | | | | __________________________________________________________________________| Brain | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| RESPIRATORY SYSTEM | | | | __________________________________________________________________________| Lung | + + + + + + + + + + + + + A + + + + + + + + + + +| _____________________________________________________________________________________________________________________| Page 16 NTP Experiment-Test: 05108-01 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:43:56 _____________________________________________________________________________________________________________________ | 7| 7| 7| 4| 4| 7| 7| 5| 5| 5| 7| 7| 6| 5| 4| 7| 7| 6| 7| 7| 7| 7| 7| 6| 4| DAY ON TEST | 3| 3| 3| 7| 5| 3| 3| 9| 9| 9| 3| 3| 3| 6| 5| 1| 3| 3| 3| 3| 3| 3| 3| 5| 5| | 6| 6| 6| 9| 0| 5| 5| 7| 7| 1| 6| 6| 2| 6| 1| 7| 5| 2| 6| 6| 6| 6| 4| 7| 1| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| FISCHER 344 RATS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 8.3 | 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 5| 5| 5| 5| 5| MG/KG | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| _____________________________________________________________________________________________________________________| RESPIRATORY SYSTEM - cont | | | | Edema | 2 | Infiltration Cellular, Histiocyte | 2 1 | Alveolar Epithelium, Hyperplasia | | __________________________________________________________________________| Nose | + + + + + + + + + + + + + + + + + + + + + + + +| Fungus | 2 | Inflammation, Acute | 4 2 | __________________________________________________________________________| Trachea | + + + + + + + + + + + + + A + + + + + + + + + + +| _____________________________________________________________________________________________________________________| SPECIAL SENSES SYSTEM | | | | __________________________________________________________________________| Eye | | Lens, Cataract | | _____________________________________________________________________________________________________________________| URINARY SYSTEM | | | | __________________________________________________________________________| Kidney | + + + + + + + + + + + + + + + + + + + + + + + + +| Mineralization | 2 1 | Nephropathy | 1 1 1 1 1 1 2 3 2 3 2 1 2 1 1 1 1 2 2 1 4 1 | Cortex, Mineralization | 1 1| Pelvis, Inflammation, Chronic Active | | __________________________________________________________________________| Urinary Bladder | + + + + + + + M + + + + + A + + + + + + + + + + +| _____________________________________________________________________________________________________________________| Page 17 NTP Experiment-Test: 05108-01 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:43:56 __________________________________________________________________________________________________________________________________ | 7| 7| 7| 6| 4| 7| 7| 7| 7| 4| | | DAY ON TEST | 3| 3| 0| 9| 5| 3| 3| 3| 3| 5| | | | 5| 6| 4| 2| 1| 6| 6| 5| 5| 0| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | FISCHER 344 RATS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| | A | 8.3 | 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| | L | MG/KG | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| | | __________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM | | | | | | __________________________________________________________________________|____________| Esophagus | + + + + + + + + + + | 59 | Erosion | | 1 3.0| Hyperkeratosis | | 1 3.0| Inflammation, Acute | | 1 2.0| __________________________________________________________________________|____________| Intestine Large, Colon | + + + + + + + + + + | 57 | __________________________________________________________________________|____________| Intestine Large, Rectum | + + + + + + + + + + | 57 | __________________________________________________________________________|____________| Intestine Large, Cecum | + + + + + + + + + + | 57 | __________________________________________________________________________|____________| Intestine Small, Duodenum | + + + + + + + + + + | 57 | __________________________________________________________________________|____________| Intestine Small, Jejunum | + + + + + + + + + + | 57 | __________________________________________________________________________|____________| Intestine Small, Ileum | + + + + + + + + + + | 57 | __________________________________________________________________________|____________| Liver | + + + + + + + + + + | 59 | Basophilic Focus | X X X X | 32 | Hepatodiaphragmatic Nodule | X | 6 | Inflammation, Granulomatous | | 1 1.0| Mixed Cell Focus | | 1 | Bile Duct, Hyperplasia | | 1 1.0| __________________________________________________________________________|____________| Mesentery | | 3 | Fat, Necrosis | | 2 3.0| __________________________________________________________________________|____________| Pancreas | + + + + + + + + + + | 59 | Acinus, Hyperplasia | 2 | 1 2.0| __________________________________________________________________________|____________| Salivary Glands | + + + + + + + + + + | 59 | Atrophy | | 1 2.0| __________________________________________________________________________|____________| Stomach, Forestomach | + + + + + + + + + + | 59 | Hyperkeratosis | | 2 2.5| Hyperplasia, Basal Cell | | 3 1.3| __________________________________________________________________________|____________| Stomach, Glandular | + + + + + + + + + + | 58 | Hyperplasia | | 1 2.0| __________________________________________________________________________|____________| Tongue | + | 1 | _____________________________________________________________________________________________________________________| | CARDIOVASCULAR SYSTEM | | | | | | __________________________________________________________________________|____________| Heart | + + + + + + + + + + | 60 | Cardiomyopathy | 2 2 2 2 | 29 1.9| Mineralization | | 1 1.0| _____________________________________________________________________________________________________________________| | ENDOCRINE SYSTEM | | | | | | __________________________________________________________________________|____________| Adrenal Cortex | + + + + + + + + + + | 59 | Accessory Adrenal Cortical Nodule | X | 2 | Hemorrhage | | 1 3.0| Hyperplasia | | 1 2.0| __________________________________________________________________________________________________________________________________ * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 18 NTP Experiment-Test: 05108-01 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:43:56 __________________________________________________________________________________________________________________________________ | 7| 7| 7| 6| 4| 7| 7| 7| 7| 4| | | DAY ON TEST | 3| 3| 0| 9| 5| 3| 3| 3| 3| 5| | | | 5| 6| 4| 2| 1| 6| 6| 5| 5| 0| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | FISCHER 344 RATS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| | A | 8.3 | 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| | L | MG/KG | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| | | __________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM - cont | | | | | | __________________________________________________________________________|____________| Adrenal Medulla | + + + + + + + + + + | 59 | Hyperplasia | 1 | 4 1.3| __________________________________________________________________________|____________| Islets, Pancreatic | + + + + + + + + + + | 59 | Hyperplasia | 2 | 2 1.5| __________________________________________________________________________|____________| Parathyroid Gland | + + + + + + + + + + | 56 | __________________________________________________________________________|____________| Pituitary Gland | + + + + + + + + + + | 58 | Pars Distalis, Angiectasis | 3 3 2 | 24 2.1| Pars Distalis, Cyst | X | 7 | Pars Distalis, Hyperplasia | 2 2 2 2 | 20 2.2| Pars Intermedia, Hyperplasia | | 1 2.0| __________________________________________________________________________|____________| Thyroid Gland | + + + + + + + + + + | 59 | C-Cell, Hyperplasia | 1 1 1 | 6 1.0| _____________________________________________________________________________________________________________________| | GENERAL BODY SYSTEM | | | | | | None | | | _____________________________________________________________________________________________________________________| | GENITAL SYSTEM | | | | | | __________________________________________________________________________|____________| Clitoral Gland | + + + + + + M + + + | 55 | Necrosis | | 2 2.5| __________________________________________________________________________|____________| Ovary | + + + + + + + + + + | 59 | Cyst | | 1 | __________________________________________________________________________|____________| Uterus | + + + + + + + + + + | 60 | __________________________________________________________________________|____________| Vagina | | 1 | _____________________________________________________________________________________________________________________| | HEMATOPOIETIC SYSTEM | | | | | | __________________________________________________________________________|____________| Blood | + | 5 | __________________________________________________________________________|____________| Bone Marrow | + + + + + + + + + + | 59 | __________________________________________________________________________|____________| Lymph Node | + | 5 | __________________________________________________________________________|____________| Lymph Node, Mandibular | + + + + + + + + + + | 59 | Hemorrhage | | 1 2.0| __________________________________________________________________________|____________| Lymph Node, Mesenteric | + + + + + + + + + + | 59 | __________________________________________________________________________|____________| Spleen | + + + + + + + + + + | 59 | Fibrosis | | 2 2.5| Hemorrhage | | 1 2.0| __________________________________________________________________________|____________| Thymus | + + + + + + + + + + | 58 | _____________________________________________________________________________________________________________________| | INTEGUMENTARY SYSTEM | | | | | | __________________________________________________________________________|____________| Mammary Gland | + + + + + + + + + + | 54 | Galactocele | X X X | 5 | __________________________________________________________________________________________________________________________________ * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 19 NTP Experiment-Test: 05108-01 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:43:56 __________________________________________________________________________________________________________________________________ | 7| 7| 7| 6| 4| 7| 7| 7| 7| 4| | | DAY ON TEST | 3| 3| 0| 9| 5| 3| 3| 3| 3| 5| | | | 5| 6| 4| 2| 1| 6| 6| 5| 5| 0| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | FISCHER 344 RATS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| | A | 8.3 | 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| | L | MG/KG | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| | | __________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM - cont | | | | | | __________________________________________________________________________|____________| Skin | + + + + + + + + + + | 58 | _____________________________________________________________________________________________________________________| | MUSCULOSKELETAL SYSTEM | | | | | | __________________________________________________________________________|____________| Bone | + + + + + + + + + + | 59 | _____________________________________________________________________________________________________________________| | NERVOUS SYSTEM | | | | | | __________________________________________________________________________|____________| Brain | + + + + + + + + + + | 60 | _____________________________________________________________________________________________________________________| | RESPIRATORY SYSTEM | | | | | | __________________________________________________________________________|____________| Lung | + + + + + + + + + + | 59 | Edema | | 1 2.0| Infiltration Cellular, Histiocyte | | 2 1.5| Alveolar Epithelium, Hyperplasia | | 2 2.0| __________________________________________________________________________|____________| Nose | + + + + + + + + + + | 59 | Fungus | | 1 2.0| Inflammation, Acute | | 3 2.7| __________________________________________________________________________|____________| Trachea | + + + + + + + + + + | 59 | _____________________________________________________________________________________________________________________| | SPECIAL SENSES SYSTEM | | | | | | __________________________________________________________________________|____________| Eye | | 1 | Lens, Cataract | | 1 2.0| _____________________________________________________________________________________________________________________| | URINARY SYSTEM | | | | | | __________________________________________________________________________|____________| Kidney | + + + + + + + + + + | 60 | Mineralization | | 2 1.5| Nephropathy | 1 3 2 1 2 2 1 1 1 | 52 1.6| Cortex, Mineralization | 1 1 | 6 1.0| Pelvis, Inflammation, Chronic Active | 2 | 1 2.0| __________________________________________________________________________|____________| Urinary Bladder | + + + + + + + + + + | 57 | __________________________________________________________________________________________________________________________________ * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 20 NTP Experiment-Test: 05108-01 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:43:56 _____________________________________________________________________________________________________________________ | 7| 7| 7| 6| 4| 7| 7| 7| 4| 4| 7| 7| 7| 6| 4| 7| 7| 7| 4| 4| 7| 7| 7| 6| 6| DAY ON TEST | 3| 3| 3| 6| 7| 3| 3| 3| 5| 5| 3| 3| 3| 0| 5| 3| 3| 3| 5| 5| 3| 3| 3| 8| 4| | 5| 5| 5| 6| 5| 5| 5| 5| 1| 1| 5| 5| 5| 4| 1| 4| 4| 4| 7| 0| 4| 4| 4| 6| 3| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| FISCHER 344 RATS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 16.6 | 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| MG/KG | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| _____________________________________________________________________________________________________________________| ALIMENTARY SYSTEM | | | | __________________________________________________________________________| Esophagus | + + + + + + + + + + + + + + + + + + + + + + + + +| Hyperkeratosis | | __________________________________________________________________________| Intestine Large, Colon | + + + + + + + + + + + + + A + + + + + + + + + + +| __________________________________________________________________________| Intestine Large, Rectum | + + + + + + + + + + + + + A + + + + + + + + + + +| __________________________________________________________________________| Intestine Large, Cecum | + + + + + + + + + + + + + A + + + + + + + + + + +| __________________________________________________________________________| Intestine Small, Duodenum | + + + + + + + + + + + + + A + + + + + + + + + + +| Necrosis | | __________________________________________________________________________| Intestine Small, Jejunum | + + + + + + + + + + + + + A + + + + + + + + + + +| __________________________________________________________________________| Intestine Small, Ileum | + + + + + + + + + + + + + A + + + + + + + + + + +| Necrosis | | __________________________________________________________________________| Liver | + + + + + + + + + + + + + + + + + + + + + + + + +| Basophilic Focus | X X X X X X X X | Fibrosis | 2 | Hepatodiaphragmatic Nodule | X X X | Inflammation, Granulomatous | | Mixed Cell Focus | X | Necrosis | 2 | __________________________________________________________________________| Pancreas | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Salivary Glands | + + + + + + + + + + + + + + + + + + + + + + + + +| Duct, Metaplasia, Squamous | | __________________________________________________________________________| Stomach, Forestomach | + + + + + + + + + + + + + + + + + + + + + + + + +| Hyperplasia, Basal Cell | 1 | Necrosis | | __________________________________________________________________________| Stomach, Glandular | + + + + + + + + + + + + + A + + + + + + + + + + +| _____________________________________________________________________________________________________________________| CARDIOVASCULAR SYSTEM | | | | __________________________________________________________________________| Heart | + + + + + + + + + + + + + + + + + + + + + + + + +| Cardiomyopathy | 2 2 2 2 2 2 2 2 2 2 2 2 2| _____________________________________________________________________________________________________________________| ENDOCRINE SYSTEM | | | | __________________________________________________________________________| Adrenal Cortex | + + + + + + + + + + + + + + + + + + + + + + + + +| Accessory Adrenal Cortical Nodule | | Hyperplasia | | __________________________________________________________________________| Adrenal Medulla | + + + + + + + + + + + + + + + + + + + + + + + + +| Hyperplasia | 1 | __________________________________________________________________________| Islets, Pancreatic | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Parathyroid Gland | M + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Pituitary Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| Pars Distalis, Angiectasis | 2 2 2 2 2 2 2 2 2| Pars Distalis, Cyst | X | Pars Distalis, Hyperplasia | 1 3 3 3 2 2 2 | __________________________________________________________________________| Thyroid Gland | + + + + + + + + + + + + + A + + + + + + + + + + +| C-Cell, Hyperplasia | 1 2 1 | Follicle, Cyst | X | _____________________________________________________________________________________________________________________| Page 21 NTP Experiment-Test: 05108-01 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:43:56 _____________________________________________________________________________________________________________________ | 7| 7| 7| 6| 4| 7| 7| 7| 4| 4| 7| 7| 7| 6| 4| 7| 7| 7| 4| 4| 7| 7| 7| 6| 6| DAY ON TEST | 3| 3| 3| 6| 7| 3| 3| 3| 5| 5| 3| 3| 3| 0| 5| 3| 3| 3| 5| 5| 3| 3| 3| 8| 4| | 5| 5| 5| 6| 5| 5| 5| 5| 1| 1| 5| 5| 5| 4| 1| 4| 4| 4| 7| 0| 4| 4| 4| 6| 3| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| FISCHER 344 RATS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 16.6 | 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| MG/KG | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| _____________________________________________________________________________________________________________________| GENERAL BODY SYSTEM | | | | None | | _____________________________________________________________________________________________________________________| GENITAL SYSTEM | | | | __________________________________________________________________________| Clitoral Gland | M + + + + + + + + + + + + + + + + + + + + M + + +| __________________________________________________________________________| Ovary | + + + + + + + + + + + + + + + + + + + + + + + + +| Cyst | | __________________________________________________________________________| Oviduct | | __________________________________________________________________________| Uterus | + + + + + + + + + + + + + + + + + + + + + + + + +| Decidual Reaction | | _____________________________________________________________________________________________________________________| HEMATOPOIETIC SYSTEM | | | | __________________________________________________________________________| Blood | + +| __________________________________________________________________________| Bone Marrow | + + + + + + + + + + + + + + + + + + + + M + + M +| __________________________________________________________________________| Lymph Node | + + +| Pancreatic, Hemorrhage | 2 | __________________________________________________________________________| Lymph Node, Mandibular | + + + + + + + + + + + + + + + + + + + + + + + + +| Angiectasis | | __________________________________________________________________________| Lymph Node, Mesenteric | + + + + + + + + + + + + + + + + + + + + + + + + +| Angiectasis | 2 | Hemorrhage | 2 | Hyperplasia | | __________________________________________________________________________| Spleen | + + + + + + + + + + + + + + + + + + + + + + + + +| Fibrosis | 2 | Hematopoietic Cell Proliferation | | __________________________________________________________________________| Thymus | + + + + + + + + + + + + + + + + + + + + + + + + +| Fibrosis | | Epithelial Cell, Hyperplasia | | _____________________________________________________________________________________________________________________| INTEGUMENTARY SYSTEM | | | | __________________________________________________________________________| Mammary Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| Galactocele | | __________________________________________________________________________| Skin | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| MUSCULOSKELETAL SYSTEM | | | | __________________________________________________________________________| Bone | + + + + + + + + + + + + + + + + + + + + + + + + +| Fibrous Osteodystrophy | 3 | __________________________________________________________________________| Skeletal Muscle | | _____________________________________________________________________________________________________________________| NERVOUS SYSTEM | | | | __________________________________________________________________________| Brain | + + + + + + + + + + + + + + + + + + + + + + + + +| Hydrocephalus | 2 | _____________________________________________________________________________________________________________________| RESPIRATORY SYSTEM | | | | __________________________________________________________________________| Lung | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| Page 22 NTP Experiment-Test: 05108-01 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:43:56 _____________________________________________________________________________________________________________________ | 7| 7| 7| 6| 4| 7| 7| 7| 4| 4| 7| 7| 7| 6| 4| 7| 7| 7| 4| 4| 7| 7| 7| 6| 6| DAY ON TEST | 3| 3| 3| 6| 7| 3| 3| 3| 5| 5| 3| 3| 3| 0| 5| 3| 3| 3| 5| 5| 3| 3| 3| 8| 4| | 5| 5| 5| 6| 5| 5| 5| 5| 1| 1| 5| 5| 5| 4| 1| 4| 4| 4| 7| 0| 4| 4| 4| 6| 3| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| FISCHER 344 RATS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 16.6 | 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| MG/KG | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| _____________________________________________________________________________________________________________________| RESPIRATORY SYSTEM - cont | | | | Edema | | Infiltration Cellular, Histiocyte | | Inflammation, Acute | 1 | Alveolar Epithelium, Hyperplasia | | __________________________________________________________________________| Nose | + + + + + + + + + + + + + + + + + + + + + + + M +| Inflammation, Acute | 2 | __________________________________________________________________________| Trachea | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| SPECIAL SENSES SYSTEM | | | | __________________________________________________________________________| Ear | + +| __________________________________________________________________________| Eye | + | Lens, Cataract | | Retina, Atrophy | | _____________________________________________________________________________________________________________________| URINARY SYSTEM | | | | __________________________________________________________________________| Kidney | + + + + + + + + + + + + + + + + + + + + + + + + +| Inflammation, Acute | | Mineralization | | Nephropathy | 2 1 1 3 1 1 2 2 1 2 1 2 1 1 2 3 1 1 2 1 1 2 2| Bilateral, Papilla, Necrosis | | Cortex, Mineralization | 1 1 1 | __________________________________________________________________________| Urinary Bladder | + + + + + + + + + + + + + + + + + + + + + + + + +| Hemorrhage | | Necrosis | | _____________________________________________________________________________________________________________________| Page 23 NTP Experiment-Test: 05108-01 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:43:56 _____________________________________________________________________________________________________________________ | 7| 7| 5| 4| 3| 7| 7| 7| 7| 4| 7| 6| 6| 5| 4| 7| 7| 7| 6| 5| 7| 7| 6| 4| 4| DAY ON TEST | 3| 3| 4| 5| 6| 3| 3| 3| 3| 5| 3| 8| 4| 5| 5| 3| 3| 3| 7| 7| 3| 3| 1| 7| 5| | 4| 4| 7| 0| 0| 4| 4| 4| 4| 1| 5| 9| 4| 0| 1| 5| 5| 5| 5| 6| 4| 4| 4| 9| 1| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| FISCHER 344 RATS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 16.6 | 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| MG/KG | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| _____________________________________________________________________________________________________________________| ALIMENTARY SYSTEM | | | | __________________________________________________________________________| Esophagus | + + + + + + + + + + + + + + + + + + + + + + + + +| Hyperkeratosis | | __________________________________________________________________________| Intestine Large, Colon | + + A + + + + + + + + + + A + + + + + + + + A A +| __________________________________________________________________________| Intestine Large, Rectum | + + A + + + + + + + + + + A + + + + + + + + A A +| __________________________________________________________________________| Intestine Large, Cecum | + + A + A + + + + + + + + A + + + + + + + + A A +| __________________________________________________________________________| Intestine Small, Duodenum | + + A + + + + + + + + + + A + + + + + + + + A A +| Necrosis | 3 | __________________________________________________________________________| Intestine Small, Jejunum | + + A + + + + + + + + + + A + + + + + + + + A A +| __________________________________________________________________________| Intestine Small, Ileum | + + A + + + + + + + + + + A + + + + + + + + A A +| Necrosis | 3 | __________________________________________________________________________| Liver | + + + + + + + + + + + + + + + + + + + + + + + + +| Basophilic Focus | X X X X X X X X X X X| Fibrosis | 2 | Hepatodiaphragmatic Nodule | X| Inflammation, Granulomatous | 1 | Mixed Cell Focus | X | Necrosis | | __________________________________________________________________________| Pancreas | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Salivary Glands | + + + + + + + + + + + + + A + + + + + + + + + + +| Duct, Metaplasia, Squamous | 1 1 | __________________________________________________________________________| Stomach, Forestomach | + + + + + + + + + + + + + + + + + + + + + + + + +| Hyperplasia, Basal Cell | | Necrosis | 2 | __________________________________________________________________________| Stomach, Glandular | + + A + A + + + + + + + + A + + + + + + + + + A +| _____________________________________________________________________________________________________________________| CARDIOVASCULAR SYSTEM | | | | __________________________________________________________________________| Heart | + + + + + + + + + + + + + + + + + + + + + + + + +| Cardiomyopathy | 2 2 1 2 2 2 2 2 2 2| _____________________________________________________________________________________________________________________| ENDOCRINE SYSTEM | | | | __________________________________________________________________________| Adrenal Cortex | + + A + + + + + + + + + + + + + + + + + + + + + +| Accessory Adrenal Cortical Nodule | X | Hyperplasia | | __________________________________________________________________________| Adrenal Medulla | + + + + + + + + + + + + + + + + + + + + + + + + +| Hyperplasia | 1 1 | __________________________________________________________________________| Islets, Pancreatic | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Parathyroid Gland | + + + + + + M + + + + + + M + + + + + + + + + + +| __________________________________________________________________________| Pituitary Gland | + + + + + + + + + + + + + A + + + + + + + + + A +| Pars Distalis, Angiectasis | 2 2 2 2 2 2 2 3 | Pars Distalis, Cyst | X | Pars Distalis, Hyperplasia | 3 2 2 2 2 2 2 2 | __________________________________________________________________________| Thyroid Gland | + + A + + + + + + + + + + A + + + + + + + + + A +| C-Cell, Hyperplasia | 2 1 1 1 3 | Follicle, Cyst | | _____________________________________________________________________________________________________________________| Page 24 NTP Experiment-Test: 05108-01 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:43:56 _____________________________________________________________________________________________________________________ | 7| 7| 5| 4| 3| 7| 7| 7| 7| 4| 7| 6| 6| 5| 4| 7| 7| 7| 6| 5| 7| 7| 6| 4| 4| DAY ON TEST | 3| 3| 4| 5| 6| 3| 3| 3| 3| 5| 3| 8| 4| 5| 5| 3| 3| 3| 7| 7| 3| 3| 1| 7| 5| | 4| 4| 7| 0| 0| 4| 4| 4| 4| 1| 5| 9| 4| 0| 1| 5| 5| 5| 5| 6| 4| 4| 4| 9| 1| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| FISCHER 344 RATS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 16.6 | 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| MG/KG | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| _____________________________________________________________________________________________________________________| GENERAL BODY SYSTEM | | | | None | | _____________________________________________________________________________________________________________________| GENITAL SYSTEM | | | | __________________________________________________________________________| Clitoral Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Ovary | + + + + + + + + + + + + + + + + + + + + + + + + +| Cyst | X X| __________________________________________________________________________| Oviduct | | __________________________________________________________________________| Uterus | + + + + + + + + + + + + + + + + + + + + + + + + +| Decidual Reaction | | _____________________________________________________________________________________________________________________| HEMATOPOIETIC SYSTEM | | | | __________________________________________________________________________| Blood | | __________________________________________________________________________| Bone Marrow | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Lymph Node | + | Pancreatic, Hemorrhage | | __________________________________________________________________________| Lymph Node, Mandibular | + + + + + + + + + + + + + + + + + + + + + + + + +| Angiectasis | 2 | __________________________________________________________________________| Lymph Node, Mesenteric | + + + + + + + + + + + + + + + + + + + + + + + + +| Angiectasis | | Hemorrhage | | Hyperplasia | 1 | __________________________________________________________________________| Spleen | + + + + + + + + + + + + + + + + + + + + + + + + +| Fibrosis | | Hematopoietic Cell Proliferation | 3 | __________________________________________________________________________| Thymus | + + + + + + + M + + + + + M + + + + + + + + + + M| Fibrosis | 2 | Epithelial Cell, Hyperplasia | 1 | _____________________________________________________________________________________________________________________| INTEGUMENTARY SYSTEM | | | | __________________________________________________________________________| Mammary Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| Galactocele | X X X | __________________________________________________________________________| Skin | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| MUSCULOSKELETAL SYSTEM | | | | __________________________________________________________________________| Bone | + + + + + + + + + + + + + + + + + + + + + + + + +| Fibrous Osteodystrophy | | __________________________________________________________________________| Skeletal Muscle | + | _____________________________________________________________________________________________________________________| NERVOUS SYSTEM | | | | __________________________________________________________________________| Brain | + + + + + + + + + + + + + + + + + + + + + + + + +| Hydrocephalus | | _____________________________________________________________________________________________________________________| RESPIRATORY SYSTEM | | | | __________________________________________________________________________| Lung | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| Page 25 NTP Experiment-Test: 05108-01 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:43:56 _____________________________________________________________________________________________________________________ | 7| 7| 5| 4| 3| 7| 7| 7| 7| 4| 7| 6| 6| 5| 4| 7| 7| 7| 6| 5| 7| 7| 6| 4| 4| DAY ON TEST | 3| 3| 4| 5| 6| 3| 3| 3| 3| 5| 3| 8| 4| 5| 5| 3| 3| 3| 7| 7| 3| 3| 1| 7| 5| | 4| 4| 7| 0| 0| 4| 4| 4| 4| 1| 5| 9| 4| 0| 1| 5| 5| 5| 5| 6| 4| 4| 4| 9| 1| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| FISCHER 344 RATS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 16.6 | 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| MG/KG | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| _____________________________________________________________________________________________________________________| RESPIRATORY SYSTEM - cont | | | | Edema | | Infiltration Cellular, Histiocyte | | Inflammation, Acute | 2 | Alveolar Epithelium, Hyperplasia | | __________________________________________________________________________| Nose | + + + + + + + + + + + + + + + + + + + + + + + + +| Inflammation, Acute | 2 1 2| __________________________________________________________________________| Trachea | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| SPECIAL SENSES SYSTEM | | | | __________________________________________________________________________| Ear | + | __________________________________________________________________________| Eye | | Lens, Cataract | | Retina, Atrophy | | _____________________________________________________________________________________________________________________| URINARY SYSTEM | | | | __________________________________________________________________________| Kidney | + + + + + + + + + + + + + + + + + + + + + + + A +| Inflammation, Acute | | Mineralization | 1 | Nephropathy | 2 3 1 2 3 1 2 2 2 1 2 1 2 1 1 1 3 2 2 2 | Bilateral, Papilla, Necrosis | | Cortex, Mineralization | 1 1 1| __________________________________________________________________________| Urinary Bladder | + + A + + + + + + + + + + A + + + + + + + + + A +| Hemorrhage | | Necrosis | | _____________________________________________________________________________________________________________________| Page 26 NTP Experiment-Test: 05108-01 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:43:56 __________________________________________________________________________________________________________________________________ | 7| 7| 6| 5| 4| 7| 7| 6| 4| 3| | | DAY ON TEST | 3| 3| 5| 5| 5| 3| 3| 8| 5| 0| | | | 4| 4| 2| 0| 0| 4| 4| 5| 0| 6| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | FISCHER 344 RATS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| | A | 16.6 | 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| | L | MG/KG | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| | | __________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM | | | | | | __________________________________________________________________________|____________| Esophagus | + + + + + + + + + + | 60 | Hyperkeratosis | 2 | 1 2.0| __________________________________________________________________________|____________| Intestine Large, Colon | + + + A + + + + + A | 53 | __________________________________________________________________________|____________| Intestine Large, Rectum | + + + A + + + + + + | 54 | __________________________________________________________________________|____________| Intestine Large, Cecum | + + + A + + + + + A | 52 | __________________________________________________________________________|____________| Intestine Small, Duodenum | + + + A + + + + + + | 54 | Necrosis | | 1 3.0| __________________________________________________________________________|____________| Intestine Small, Jejunum | + + + A + + + + + A | 53 | __________________________________________________________________________|____________| Intestine Small, Ileum | + + + A + + + + + A | 53 | Necrosis | | 1 3.0| __________________________________________________________________________|____________| Liver | + + + + + + + + + + | 60 | Basophilic Focus | X X X X | 23 | Fibrosis | | 2 2.0| Hepatodiaphragmatic Nodule | X | 5 | Inflammation, Granulomatous | 2 | 2 1.5| Mixed Cell Focus | | 2 | Necrosis | | 1 2.0| __________________________________________________________________________|____________| Pancreas | + + + + + + + + + + | 60 | __________________________________________________________________________|____________| Salivary Glands | + + + + + + + + + + | 59 | Duct, Metaplasia, Squamous | | 2 1.0| __________________________________________________________________________|____________| Stomach, Forestomach | + + + + + + + + + + | 60 | Hyperplasia, Basal Cell | | 1 1.0| Necrosis | 3 | 2 2.5| __________________________________________________________________________|____________| Stomach, Glandular | + + + A + + + + + + | 54 | _____________________________________________________________________________________________________________________| | CARDIOVASCULAR SYSTEM | | | | | | __________________________________________________________________________|____________| Heart | + + + + + + + + + + | 60 | Cardiomyopathy | 2 2 2 2 1 | 28 1.9| _____________________________________________________________________________________________________________________| | ENDOCRINE SYSTEM | | | | | | __________________________________________________________________________|____________| Adrenal Cortex | + + + + + + + + + + | 59 | Accessory Adrenal Cortical Nodule | | 1 | Hyperplasia | 2 | 1 2.0| __________________________________________________________________________|____________| Adrenal Medulla | + + + + + + + + + + | 60 | Hyperplasia | | 3 1.0| __________________________________________________________________________|____________| Islets, Pancreatic | + + + + + + + + + + | 60 | __________________________________________________________________________|____________| Parathyroid Gland | M + + M + + + + + + | 55 | __________________________________________________________________________|____________| Pituitary Gland | + + + + + + + + + + | 58 | Pars Distalis, Angiectasis | 2 2 2 | 20 2.1| __________________________________________________________________________________________________________________________________ * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 27 NTP Experiment-Test: 05108-01 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:43:56 __________________________________________________________________________________________________________________________________ | 7| 7| 6| 5| 4| 7| 7| 6| 4| 3| | | DAY ON TEST | 3| 3| 5| 5| 5| 3| 3| 8| 5| 0| | | | 4| 4| 2| 0| 0| 4| 4| 5| 0| 6| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | FISCHER 344 RATS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| | A | 16.6 | 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| | L | MG/KG | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| | | __________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM - cont | | | | | | Pars Distalis, Cyst | X | 3 | Pars Distalis, Hyperplasia | 2 3 2 | 18 2.2| __________________________________________________________________________|____________| Thyroid Gland | + + + A + + + + + + | 55 | C-Cell, Hyperplasia | | 8 1.5| Follicle, Cyst | | 1 | _____________________________________________________________________________________________________________________| | GENERAL BODY SYSTEM | | | | | | None | | | _____________________________________________________________________________________________________________________| | GENITAL SYSTEM | | | | | | __________________________________________________________________________|____________| Clitoral Gland | + + + + + + + + + + | 58 | __________________________________________________________________________|____________| Ovary | + + + + + + + + + + | 60 | Cyst | | 2 | __________________________________________________________________________|____________| Oviduct | + | 1 | __________________________________________________________________________|____________| Uterus | + + + + + + + + + + | 60 | Decidual Reaction | 4 | 1 4.0| _____________________________________________________________________________________________________________________| | HEMATOPOIETIC SYSTEM | | | | | | __________________________________________________________________________|____________| Blood | + | 3 | __________________________________________________________________________|____________| Bone Marrow | + + + + + + + + + + | 58 | __________________________________________________________________________|____________| Lymph Node | + | 5 | Pancreatic, Hemorrhage | | 1 2.0| __________________________________________________________________________|____________| Lymph Node, Mandibular | + + + + + + + + M + | 59 | Angiectasis | | 1 2.0| __________________________________________________________________________|____________| Lymph Node, Mesenteric | + + + + + + + + + + | 60 | Angiectasis | | 1 2.0| Hemorrhage | | 1 2.0| Hyperplasia | | 1 1.0| __________________________________________________________________________|____________| Spleen | + + + + + + + + + + | 60 | Fibrosis | | 1 2.0| Hematopoietic Cell Proliferation | 3 | 2 3.0| __________________________________________________________________________|____________| Thymus | + + + + + + + + + + | 57 | Fibrosis | | 1 2.0| Epithelial Cell, Hyperplasia | | 1 1.0| _____________________________________________________________________________________________________________________| | INTEGUMENTARY SYSTEM | | | | | | __________________________________________________________________________|____________| Mammary Gland | + + + + + + + + M + | 59 | Galactocele | X X | 5 | __________________________________________________________________________|____________| Skin | + + + + + + + + + + | 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: 05108-01 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:43:56 __________________________________________________________________________________________________________________________________ | 7| 7| 6| 5| 4| 7| 7| 6| 4| 3| | | DAY ON TEST | 3| 3| 5| 5| 5| 3| 3| 8| 5| 0| | | | 4| 4| 2| 0| 0| 4| 4| 5| 0| 6| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | FISCHER 344 RATS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| | A | 16.6 | 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| | L | MG/KG | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| | | __________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM - cont | | | | | | _____________________________________________________________________________________________________________________| | MUSCULOSKELETAL SYSTEM | | | | | | __________________________________________________________________________|____________| Bone | + + + + + + + + + + | 60 | Fibrous Osteodystrophy | | 1 3.0| __________________________________________________________________________|____________| Skeletal Muscle | + | 2 | _____________________________________________________________________________________________________________________| | NERVOUS SYSTEM | | | | | | __________________________________________________________________________|____________| Brain | + + + + + + + + + + | 60 | Hydrocephalus | | 1 2.0| _____________________________________________________________________________________________________________________| | RESPIRATORY SYSTEM | | | | | | __________________________________________________________________________|____________| Lung | + + + + + + + + + + | 60 | Edema | 2 1 | 2 1.5| Infiltration Cellular, Histiocyte | 2 | 1 2.0| Inflammation, Acute | | 2 1.5| Alveolar Epithelium, Hyperplasia | 2 | 1 2.0| __________________________________________________________________________|____________| Nose | + + + + + + + + + + | 59 | Inflammation, Acute | 1 1 | 6 1.5| __________________________________________________________________________|____________| Trachea | + + + + + + + + + + | 60 | _____________________________________________________________________________________________________________________| | SPECIAL SENSES SYSTEM | | | | | | __________________________________________________________________________|____________| Ear | | 3 | __________________________________________________________________________|____________| Eye | + + | 3 | Lens, Cataract | 3 | 1 3.0| Retina, Atrophy | 2 | 1 2.0| _____________________________________________________________________________________________________________________| | URINARY SYSTEM | | | | | | __________________________________________________________________________|____________| Kidney | + + + + + + + + + + | 59 | Inflammation, Acute | 2 | 1 2.0| Mineralization | | 1 1.0| Nephropathy | 2 1 1 1 2 2 2 | 50 1.7| Bilateral, Papilla, Necrosis | 3 | 1 3.0| Cortex, Mineralization | 1 1 | 8 1.0| __________________________________________________________________________|____________| Urinary Bladder | + + + A + + + + + + | 56 | Hemorrhage | 3 | 1 3.0| Necrosis | 4 | 1 4.0| __________________________________________________________________________________________________________________________________ * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 29 NTP Experiment-Test: 05108-01 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:43:56 _____________________________________________________________________________________________________________________ | 7| 6| 6| 5| 3| 7| 6| 5| 4| 4| 7| 7| 4| 2| 0| 7| 7| 6| 5| 4| 7| 7| 5| 4| 4| DAY ON TEST | 3| 6| 2| 5| 9| 3| 5| 7| 5| 2| 3| 3| 5| 5| 3| 3| 3| 8| 9| 7| 3| 3| 9| 5| 5| | 4| 6| 9| 0| 3| 1| 1| 5| 1| 1| 1| 1| 0| 9| 0| 1| 1| 9| 1| 0| 1| 1| 0| 1| 0| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| FISCHER 344 RATS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 33.3 | 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| MG/KG | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| _____________________________________________________________________________________________________________________| ALIMENTARY SYSTEM | | | | __________________________________________________________________________| Esophagus | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Large, Colon | + + + A + + + + + + + + + A A + + + A + + + A + +| __________________________________________________________________________| Intestine Large, Rectum | + + + A A + + + + + + + + A A + + + A + + + A + +| __________________________________________________________________________| Intestine Large, Cecum | + + + A A + A + + + + + + A A + + + A A + + A + +| __________________________________________________________________________| Intestine Small, Duodenum | + + + A A + A + + + + + + + A + + + A + + + A + +| __________________________________________________________________________| Intestine Small, Jejunum | + + + A A + A + + + + + + A A + + + A A + + A + +| __________________________________________________________________________| Intestine Small, Ileum | + + + A A + A + + + + + + A A + + + A A + + A + +| __________________________________________________________________________| Liver | + + + + + + + + + + + + + + + + + + + + + + + + +| Basophilic Focus | X X X X X X X X X X | Clear Cell Focus | | Fatty Change, Focal | 2 | Hepatodiaphragmatic Nodule | X X X X X X | Inflammation, Granulomatous | | Mixed Cell Focus | X X | Pigmentation | | __________________________________________________________________________| Mesentery | + | __________________________________________________________________________| Pancreas | + + + + + + + + + + + + + + M + + + + + + + + + +| Acinus, Atrophy | 2 | __________________________________________________________________________| Salivary Glands | + + + + + + + + + + + + + + + + + + + + + + + + +| Duct, Metaplasia, Squamous | | __________________________________________________________________________| Stomach, Forestomach | + + + + + + + + + + + + + + + + + + + + + + + + +| Hyperkeratosis | | Hyperplasia, Basal Cell | 2 | Ulcer | 2 | __________________________________________________________________________| Stomach, Glandular | + + + A + + + + + + + + + + A + + + A + + + A + +| Hyperplasia | 1 | Mineralization | | _____________________________________________________________________________________________________________________| CARDIOVASCULAR SYSTEM | | | | __________________________________________________________________________| Heart | + + + + + + + + + + + + + + + + + + + + + + + + +| Cardiomyopathy | 2 1 2 2 2 1 2 2 2 2 2 | Inflammation, Chronic Active | 2 | _____________________________________________________________________________________________________________________| ENDOCRINE SYSTEM | | | | __________________________________________________________________________| Adrenal Cortex | + + + + + + + + + + + + + + + + + + + + + + + + +| Hyperplasia | | __________________________________________________________________________| Adrenal Medulla | + + + + + + + + + + + + + + + + + + + + + + + + +| Hyperplasia | | __________________________________________________________________________| Islets, Pancreatic | + + + + + + + + + + + + + + M + + + + + + + + + +| __________________________________________________________________________| Parathyroid Gland | + + + + + + + + + + + + + M + + + + + M + + + + +| __________________________________________________________________________| Pituitary Gland | + + + + + + + + + + + + + + M + + + + + + + + + +| Craniopharyngeal Duct, Cyst | | Pars Distalis, Angiectasis | 2 2 2 3 2 1 2 | Pars Distalis, Hyperplasia | 1 2 2 2 2 3 1| _____________________________________________________________________________________________________________________| Page 30 NTP Experiment-Test: 05108-01 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:43:56 _____________________________________________________________________________________________________________________ | 7| 6| 6| 5| 3| 7| 6| 5| 4| 4| 7| 7| 4| 2| 0| 7| 7| 6| 5| 4| 7| 7| 5| 4| 4| DAY ON TEST | 3| 6| 2| 5| 9| 3| 5| 7| 5| 2| 3| 3| 5| 5| 3| 3| 3| 8| 9| 7| 3| 3| 9| 5| 5| | 4| 6| 9| 0| 3| 1| 1| 5| 1| 1| 1| 1| 0| 9| 0| 1| 1| 9| 1| 0| 1| 1| 0| 1| 0| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| FISCHER 344 RATS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 33.3 | 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| MG/KG | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| _____________________________________________________________________________________________________________________| ENDOCRINE SYSTEM - cont | | | | Pars Intermedia, Hyperplasia | 3| __________________________________________________________________________| Thyroid Gland | + + + + + + + + + + + + + + A + + + A + + + + + +| C-Cell, Hyperplasia | 1 1 | Follicle, Cyst | X | Follicular Cell, Hyperplasia | | _____________________________________________________________________________________________________________________| GENERAL BODY SYSTEM | | | | None | | _____________________________________________________________________________________________________________________| GENITAL SYSTEM | | | | __________________________________________________________________________| Clitoral Gland | + + + + + + + + + + + + + + A + + + + + + + + + +| Dilatation | | Inflammation, Acute | | __________________________________________________________________________| Ovary | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Uterus | + + + + + + + + + + + + + + A + + + + + + + + + +| Cyst | | Hemorrhage | 4 | _____________________________________________________________________________________________________________________| HEMATOPOIETIC SYSTEM | | | | __________________________________________________________________________| Blood | + + | __________________________________________________________________________| Bone Marrow | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Lymph Node | + + | Mediastinal, Angiectasis | 3 | Mediastinal, Pigmentation | | __________________________________________________________________________| Lymph Node, Mandibular | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Lymph Node, Mesenteric | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Spleen | + + + + + + + + + + + + + + + + + + + + + + + + +| Hematopoietic Cell Proliferation | | Infarct | | __________________________________________________________________________| Thymus | + + + + + + + + + + M + + + A + + + + + + + + + +| Epithelial Cell, Ectopic Parathyroid | | Gland | 3 | _____________________________________________________________________________________________________________________| INTEGUMENTARY SYSTEM | | | | __________________________________________________________________________| Mammary Gland | + + + + M + + + + + + + + + M + + + + + + + + M +| Galactocele | X X X | __________________________________________________________________________| Skin | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| MUSCULOSKELETAL SYSTEM | | | | __________________________________________________________________________| Bone | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| NERVOUS SYSTEM | | | | __________________________________________________________________________| Brain | + + + + + + + + + + + + + + + + + + + + + + + + +| Degeneration | | _____________________________________________________________________________________________________________________| Page 31 NTP Experiment-Test: 05108-01 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:43:56 _____________________________________________________________________________________________________________________ | 7| 6| 6| 5| 3| 7| 6| 5| 4| 4| 7| 7| 4| 2| 0| 7| 7| 6| 5| 4| 7| 7| 5| 4| 4| DAY ON TEST | 3| 6| 2| 5| 9| 3| 5| 7| 5| 2| 3| 3| 5| 5| 3| 3| 3| 8| 9| 7| 3| 3| 9| 5| 5| | 4| 6| 9| 0| 3| 1| 1| 5| 1| 1| 1| 1| 0| 9| 0| 1| 1| 9| 1| 0| 1| 1| 0| 1| 0| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| FISCHER 344 RATS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 33.3 | 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| MG/KG | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| _____________________________________________________________________________________________________________________| NERVOUS SYSTEM - cont | | | | _____________________________________________________________________________________________________________________| RESPIRATORY SYSTEM | | | | __________________________________________________________________________| Lung | + + + + + + + + + + + + + + + + + + + + + + + + +| Hemorrhage | | Infiltration Cellular, Histiocyte | 3 | __________________________________________________________________________| Nose | + + + + + + + + + + + + + + + + + + + + + + + + +| Inflammation, Acute | 1 1 | __________________________________________________________________________| Trachea | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| SPECIAL SENSES SYSTEM | | | | __________________________________________________________________________| Eye | + | Lens, Cataract | | __________________________________________________________________________| Zymbal's Gland | | _____________________________________________________________________________________________________________________| URINARY SYSTEM | | | | __________________________________________________________________________| Kidney | + + + + + + + + + + + + + + + + + + + + + + + + +| Nephropathy | 2 2 1 1 1 1 1 2 2 1 2 2 1 1 1 2 1 2 1| Cortex, Mineralization | 1 1 | __________________________________________________________________________| Urinary Bladder | + + + + + + + + + + + + + + A + + + + + + + + + +| _____________________________________________________________________________________________________________________| Page 32 NTP Experiment-Test: 05108-01 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:43:56 _____________________________________________________________________________________________________________________ | 7| 7| 7| 7| 3| 7| 7| 5| 5| 0| 7| 7| 4| 4| 3| 7| 7| 7| 5| 3| 7| 7| 4| 4| 3| DAY ON TEST | 3| 3| 3| 3| 1| 3| 2| 6| 5| 8| 3| 0| 5| 4| 1| 3| 3| 3| 5| 9| 3| 3| 5| 4| 7| | 1| 1| 1| 1| 1| 1| 9| 2| 0| 3| 1| 2| 0| 1| 1| 4| 4| 5| 2| 3| 4| 4| 1| 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| FISCHER 344 RATS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 33.3 | 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| MG/KG | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| _____________________________________________________________________________________________________________________| ALIMENTARY SYSTEM | | | | __________________________________________________________________________| Esophagus | + + + + + + + + + A + + + + M + + + + + + + + + +| __________________________________________________________________________| Intestine Large, Colon | + + + + + + + + A A + A + A A + + + + A + + + + +| __________________________________________________________________________| Intestine Large, Rectum | + + + + + + + + A A + A + A M + + + + A + + + A +| __________________________________________________________________________| Intestine Large, Cecum | + + + + + + + + A A + A + A M + + + + A + + + A +| __________________________________________________________________________| Intestine Small, Duodenum | + + + + + + + + A A + A + M M + + + + A + + + A +| __________________________________________________________________________| Intestine Small, Jejunum | + + + + + + + + A A + A + A M + + + + A + + + A +| __________________________________________________________________________| Intestine Small, Ileum | + + + + + + + + A A + A + A M + M + + A + + + A +| __________________________________________________________________________| Liver | + + + + + + + + + A + + + + + + + + + + + + + + +| Basophilic Focus | X X X X X X X| Clear Cell Focus | | Fatty Change, Focal | | Hepatodiaphragmatic Nodule | X X X X | Inflammation, Granulomatous | 1 | Mixed Cell Focus | X X X | Pigmentation | | __________________________________________________________________________| Mesentery | | __________________________________________________________________________| Pancreas | + + + + + + + + + A + + + M M + + + + + + + + + +| Acinus, Atrophy | | __________________________________________________________________________| Salivary Glands | + + + + + + + + + A + + + + + + + + + + + + + + +| Duct, Metaplasia, Squamous | | __________________________________________________________________________| Stomach, Forestomach | + + + + + + + + + A + + + M M + + + + + + + + + +| Hyperkeratosis | | Hyperplasia, Basal Cell | | Ulcer | | __________________________________________________________________________| Stomach, Glandular | + + + + + + + + A A + + + M M + + + + A + + + + +| Hyperplasia | | Mineralization | | _____________________________________________________________________________________________________________________| CARDIOVASCULAR SYSTEM | | | | __________________________________________________________________________| Heart | + + + + + + + + + A + + + + + + + + + + + + + + +| Cardiomyopathy | 2 2 2 2 2 2 2 2 2 2 1 | Inflammation, Chronic Active | | _____________________________________________________________________________________________________________________| ENDOCRINE SYSTEM | | | | __________________________________________________________________________| Adrenal Cortex | + + + + + + + + + A + + + + M + + + + + + + + + +| Hyperplasia | 3 2 | __________________________________________________________________________| Adrenal Medulla | + + + + + + + + + A + + + + M + + + + + + + + + +| Hyperplasia | 2 | __________________________________________________________________________| Islets, Pancreatic | + + + + + + + + + A + A + M M + + + + + + + + + +| __________________________________________________________________________| Parathyroid Gland | + + + + + + + + + A + + + + M + + + M + + + M + M| __________________________________________________________________________| Pituitary Gland | + + + + + + + + + A + + + + + + + + + + + + + + +| Craniopharyngeal Duct, Cyst | X | Pars Distalis, Angiectasis | 2 2 2 2 1 2 | Pars Distalis, Hyperplasia | 3 1 2 2 3 3 2 2| _____________________________________________________________________________________________________________________| Page 33 NTP Experiment-Test: 05108-01 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:43:56 _____________________________________________________________________________________________________________________ | 7| 7| 7| 7| 3| 7| 7| 5| 5| 0| 7| 7| 4| 4| 3| 7| 7| 7| 5| 3| 7| 7| 4| 4| 3| DAY ON TEST | 3| 3| 3| 3| 1| 3| 2| 6| 5| 8| 3| 0| 5| 4| 1| 3| 3| 3| 5| 9| 3| 3| 5| 4| 7| | 1| 1| 1| 1| 1| 1| 9| 2| 0| 3| 1| 2| 0| 1| 1| 4| 4| 5| 2| 3| 4| 4| 1| 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| FISCHER 344 RATS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 33.3 | 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| MG/KG | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| _____________________________________________________________________________________________________________________| ENDOCRINE SYSTEM - cont | | | | Pars Intermedia, Hyperplasia | | __________________________________________________________________________| Thyroid Gland | + + + + + + + + A + + + + + M + + + + A + + + A +| C-Cell, Hyperplasia | 1 2 1 1 | Follicle, Cyst | | Follicular Cell, Hyperplasia | 2 | _____________________________________________________________________________________________________________________| GENERAL BODY SYSTEM | | | | None | | _____________________________________________________________________________________________________________________| GENITAL SYSTEM | | | | __________________________________________________________________________| Clitoral Gland | + + + + + + + + + A + + + + M + + + + + + + + + +| Dilatation | 3 | Inflammation, Acute | 3 | __________________________________________________________________________| Ovary | + + + + + + + + + A + + + + M + + + + + + + + + +| __________________________________________________________________________| Uterus | + + + + + + + + + A + + + + M + + + + + + + + + +| Cyst | | Hemorrhage | | _____________________________________________________________________________________________________________________| HEMATOPOIETIC SYSTEM | | | | __________________________________________________________________________| Blood | + + + | __________________________________________________________________________| Bone Marrow | + + + + + + + + + A + + + + + + + + + + + + + + +| __________________________________________________________________________| Lymph Node | + + | Mediastinal, Angiectasis | | Mediastinal, Pigmentation | 2 | __________________________________________________________________________| Lymph Node, Mandibular | + + + + + + + + + A + + + + + + + + + + + + + + +| __________________________________________________________________________| Lymph Node, Mesenteric | + + + + + + + + + M + + + + M + + + + + + + + + +| __________________________________________________________________________| Spleen | + + + + + + + + + A + + + M M + + + + A + + + + +| Hematopoietic Cell Proliferation | 3| Infarct | | __________________________________________________________________________| Thymus | + + + + + + + + M A + + + + + + + + + + + M + + +| Epithelial Cell, Ectopic Parathyroid | | Gland | | _____________________________________________________________________________________________________________________| INTEGUMENTARY SYSTEM | | | | __________________________________________________________________________| Mammary Gland | + M + + + + + + + A + + + A M + + + + + + + + + +| Galactocele | X | __________________________________________________________________________| Skin | + + + + + + + + + A + + + + M + + + + + + + + + +| _____________________________________________________________________________________________________________________| MUSCULOSKELETAL SYSTEM | | | | __________________________________________________________________________| Bone | + + + + + + + + + A + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| NERVOUS SYSTEM | | | | __________________________________________________________________________| Brain | + + + + + + + + + M + + + + + + + + + + + + + + +| Degeneration | 2 | _____________________________________________________________________________________________________________________| Page 34 NTP Experiment-Test: 05108-01 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:43:56 _____________________________________________________________________________________________________________________ | 7| 7| 7| 7| 3| 7| 7| 5| 5| 0| 7| 7| 4| 4| 3| 7| 7| 7| 5| 3| 7| 7| 4| 4| 3| DAY ON TEST | 3| 3| 3| 3| 1| 3| 2| 6| 5| 8| 3| 0| 5| 4| 1| 3| 3| 3| 5| 9| 3| 3| 5| 4| 7| | 1| 1| 1| 1| 1| 1| 9| 2| 0| 3| 1| 2| 0| 1| 1| 4| 4| 5| 2| 3| 4| 4| 1| 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| FISCHER 344 RATS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 33.3 | 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| MG/KG | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| _____________________________________________________________________________________________________________________| NERVOUS SYSTEM - cont | | | | _____________________________________________________________________________________________________________________| RESPIRATORY SYSTEM | | | | __________________________________________________________________________| Lung | + + + + + + + + + A + + + + + + + + + + + + + + +| Hemorrhage | | Infiltration Cellular, Histiocyte | | __________________________________________________________________________| Nose | + + + + + + + + + M + + + + + + + + + + + + + + +| Inflammation, Acute | 1 2 1 2 | __________________________________________________________________________| Trachea | + + + + + + + + + A + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| SPECIAL SENSES SYSTEM | | | | __________________________________________________________________________| Eye | +| Lens, Cataract | 2| __________________________________________________________________________| Zymbal's Gland | | _____________________________________________________________________________________________________________________| URINARY SYSTEM | | | | __________________________________________________________________________| Kidney | + + + + + + + + + A + + + + M + + + + A + + + + +| Nephropathy | 1 2 2 2 2 1 1 2 1 1 1 2 3 1 2 2 | Cortex, Mineralization | 1 | __________________________________________________________________________| Urinary Bladder | + + + + + + + + A A + A + A M + + + + A + + + + +| _____________________________________________________________________________________________________________________| Page 35 NTP Experiment-Test: 05108-01 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:43:56 __________________________________________________________________________________________________________________________________ | 7| 7| 4| 2| 0| 7| 7| 6| 5| 4| | | DAY ON TEST | 3| 3| 9| 5| 2| 3| 3| 4| 8| 5| | | | 4| 4| 9| 9| 9| 2| 4| 0| 7| 0| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | FISCHER 344 RATS FEMALE | 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| | T | ANIMAL ID | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | A | 33.3 | 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| | L | MG/KG | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| | | __________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM | | | | | | __________________________________________________________________________|____________| Esophagus | + + + + + + + + + + | 58 | __________________________________________________________________________|____________| Intestine Large, Colon | + + + + + + + + + + | 49 | __________________________________________________________________________|____________| Intestine Large, Rectum | + + + A + + + + + + | 46 | __________________________________________________________________________|____________| Intestine Large, Cecum | + + + + A + + + + + | 44 | __________________________________________________________________________|____________| Intestine Small, Duodenum | + + + + + + + + + + | 47 | __________________________________________________________________________|____________| Intestine Small, Jejunum | + + + + + + + + + + | 45 | __________________________________________________________________________|____________| Intestine Small, Ileum | + + + + + + + + + + | 44 | __________________________________________________________________________|____________| Liver | + + + + + + + + + + | 59 | Basophilic Focus | X X X | 20 | Clear Cell Focus | X | 1 | Fatty Change, Focal | | 1 2.0| Hepatodiaphragmatic Nodule | | 10 | Inflammation, Granulomatous | | 1 1.0| Mixed Cell Focus | X X | 7 | Pigmentation | 2 | 1 2.0| __________________________________________________________________________|____________| Mesentery | | 1 | __________________________________________________________________________|____________| Pancreas | + + + + + + + + + + | 56 | Acinus, Atrophy | | 1 2.0| __________________________________________________________________________|____________| Salivary Glands | + + + + + + + + + + | 59 | Duct, Metaplasia, Squamous | 1 1 | 2 1.0| __________________________________________________________________________|____________| Stomach, Forestomach | + + + + + + + + + + | 57 | Hyperkeratosis | 2 | 1 2.0| Hyperplasia, Basal Cell | 2 | 2 2.0| Ulcer | | 1 2.0| __________________________________________________________________________|____________| Stomach, Glandular | + + + + + + + + + + | 51 | Hyperplasia | | 1 1.0| Mineralization | 1 | 1 1.0| _____________________________________________________________________________________________________________________| | CARDIOVASCULAR SYSTEM | | | | | | __________________________________________________________________________|____________| Heart | + + + + + + + + + + | 59 | Cardiomyopathy | 2 2 1 2 2 | 27 1.9| Inflammation, Chronic Active | | 1 2.0| _____________________________________________________________________________________________________________________| | ENDOCRINE SYSTEM | | | | | | __________________________________________________________________________|____________| Adrenal Cortex | + + + + + + + + + + | 58 | Hyperplasia | | 2 2.5| __________________________________________________________________________|____________| Adrenal Medulla | + + + + + + + + + + | 58 | Hyperplasia | | 1 2.0| __________________________________________________________________________|____________| Islets, Pancreatic | + + + + + + + + + + | 55 | __________________________________________________________________________________________________________________________________ * : 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: 05108-01 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:43:56 __________________________________________________________________________________________________________________________________ | 7| 7| 4| 2| 0| 7| 7| 6| 5| 4| | | DAY ON TEST | 3| 3| 9| 5| 2| 3| 3| 4| 8| 5| | | | 4| 4| 9| 9| 9| 2| 4| 0| 7| 0| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | FISCHER 344 RATS FEMALE | 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| | T | ANIMAL ID | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | A | 33.3 | 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| | L | MG/KG | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| | | __________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM - cont | | | | | | __________________________________________________________________________|____________| Parathyroid Gland | + + M + + + + M + + | 51 | __________________________________________________________________________|____________| Pituitary Gland | + + + + + + + + + + | 58 | Craniopharyngeal Duct, Cyst | | 1 | Pars Distalis, Angiectasis | 2 2 3 | 16 2.0| Pars Distalis, Hyperplasia | 3 2 | 17 2.1| Pars Intermedia, Hyperplasia | | 1 3.0| __________________________________________________________________________|____________| Thyroid Gland | + + + + + + + + + + | 54 | C-Cell, Hyperplasia | 1 | 7 1.1| Follicle, Cyst | | 1 | Follicular Cell, Hyperplasia | | 1 2.0| _____________________________________________________________________________________________________________________| | GENERAL BODY SYSTEM | | | | | | None | | | _____________________________________________________________________________________________________________________| | GENITAL SYSTEM | | | | | | __________________________________________________________________________|____________| Clitoral Gland | + + + + + + + + + + | 57 | Dilatation | | 1 3.0| Inflammation, Acute | | 1 3.0| __________________________________________________________________________|____________| Ovary | + + + + + + + + + + | 58 | __________________________________________________________________________|____________| Uterus | + + + + + + + + + + | 57 | Cyst | X | 1 | Hemorrhage | | 1 4.0| _____________________________________________________________________________________________________________________| | HEMATOPOIETIC SYSTEM | | | | | | __________________________________________________________________________|____________| Blood | | 5 | __________________________________________________________________________|____________| Bone Marrow | + + + + + + + + + + | 59 | __________________________________________________________________________|____________| Lymph Node | + | 5 | Mediastinal, Angiectasis | | 1 3.0| Mediastinal, Pigmentation | | 1 2.0| __________________________________________________________________________|____________| Lymph Node, Mandibular | + + + + + + + + + + | 59 | __________________________________________________________________________|____________| Lymph Node, Mesenteric | + + + + + + + + + + | 58 | __________________________________________________________________________|____________| Spleen | + + + + + + + + + + | 56 | Hematopoietic Cell Proliferation | | 1 3.0| Infarct | 4 | 1 4.0| __________________________________________________________________________|____________| Thymus | + + + + + + + + + + | 55 | Epithelial Cell, Ectopic Parathyroid | | | Gland | | 1 3.0| _____________________________________________________________________________________________________________________| | INTEGUMENTARY 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 37 NTP Experiment-Test: 05108-01 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:43:56 __________________________________________________________________________________________________________________________________ | 7| 7| 4| 2| 0| 7| 7| 6| 5| 4| | | DAY ON TEST | 3| 3| 9| 5| 2| 3| 3| 4| 8| 5| | | | 4| 4| 9| 9| 9| 2| 4| 0| 7| 0| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | FISCHER 344 RATS FEMALE | 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| | T | ANIMAL ID | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | A | 33.3 | 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| | L | MG/KG | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| | | __________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM - cont | | | | | | __________________________________________________________________________|____________| Mammary Gland | + + + + + + + + M + | 52 | Galactocele | X | 5 | __________________________________________________________________________|____________| Skin | + + + + + + + + + + | 58 | _____________________________________________________________________________________________________________________| | MUSCULOSKELETAL SYSTEM | | | | | | __________________________________________________________________________|____________| Bone | + + + + + + + + + + | 59 | _____________________________________________________________________________________________________________________| | NERVOUS SYSTEM | | | | | | __________________________________________________________________________|____________| Brain | + + + + + + + + + + | 59 | Degeneration | | 1 2.0| _____________________________________________________________________________________________________________________| | RESPIRATORY SYSTEM | | | | | | __________________________________________________________________________|____________| Lung | + + + + + + + + + + | 59 | Hemorrhage | 1 | 1 1.0| Infiltration Cellular, Histiocyte | | 1 3.0| __________________________________________________________________________|____________| Nose | + + + + + + + + + + | 59 | Inflammation, Acute | 1 | 7 1.3| __________________________________________________________________________|____________| Trachea | + + + + + + + + + + | 59 | _____________________________________________________________________________________________________________________| | SPECIAL SENSES SYSTEM | | | | | | __________________________________________________________________________|____________| Eye | + | 3 | Lens, Cataract | | 1 2.0| __________________________________________________________________________|____________| Zymbal's Gland | + | 1 | _____________________________________________________________________________________________________________________| | URINARY SYSTEM | | | | | | __________________________________________________________________________|____________| Kidney | + + + + + + + + + + | 57 | Nephropathy | 1 2 1 1 2 3 | 41 1.5| Cortex, Mineralization | 1 | 4 1.0| __________________________________________________________________________|____________| Urinary Bladder | + + + + + + + + + + | 53 | __________________________________________________________________________________________________________________________________ * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 38 NTP Experiment-Test: 05108-01 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:43:56 _____________________________________________________________________________________________________________________ | 7| 6| 6| 4| 4| 7| 6| 6| 4| 4| 7| 7| 7| 6| 5| 7| 7| 7| 6| 1| 7| 7| 6| 5| 4| DAY ON TEST | 3| 7| 0| 6| 6| 3| 8| 4| 6| 6| 3| 3| 3| 8| 8| 3| 3| 3| 8| 7| 3| 0| 9| 7| 6| | 0| 1| 2| 3| 2| 0| 7| 1| 3| 2| 0| 0| 0| 4| 4| 0| 0| 0| 6| 0| 0| 3| 7| 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| FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| VEHICLE | 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 5| 5| 5| 5| 5| MALE | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| _____________________________________________________________________________________________________________________| ALIMENTARY SYSTEM | | | | __________________________________________________________________________| Esophagus | + + + + + + + + + + + + + + + + + + + + + + + + +| Inflammation, Acute | 2 | __________________________________________________________________________| Intestine Large, Colon | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Large, Rectum | + + + + + + + + + + + + + + + + + + + A + + + + +| __________________________________________________________________________| Intestine Large, Cecum | + + + + + + + + + + + + + + + + + + + A + + + + +| __________________________________________________________________________| Intestine Small, Duodenum | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Small, Jejunum | + + + + + + + + + + + + + + + + + + + A + + + + +| __________________________________________________________________________| Intestine Small, Ileum | + + M + + + + + + + + + + + + + + + + A + + + + +| __________________________________________________________________________| Liver | + + + + + + + + + + + + + + + + + + + + + + + + +| Angiectasis | | Basophilic Focus | X 1 X X X X | Clear Cell Focus | X X X X | Degeneration, Cystic | 2 1 2 | Eosinophilic Focus | | Fatty Change, Diffuse | 1 1 1 1 1| Hepatodiaphragmatic Nodule | X X | Hyperplasia | | Leukocytosis | | Mixed Cell Focus | X X X | Necrosis, Focal | | Bile Duct, Hyperplasia | 1 1 1 2 2 2 1 2 1 2 1 2 2 1 1 2 1 2| __________________________________________________________________________| Mesentery | + | Fat, Mineralization | 2 | __________________________________________________________________________| Pancreas | + + + + + + + + + + + + + + + + + + + + + + + + +| Acinus, Hyperplasia | 3 | Artery, Inflammation, Chronic Active | | __________________________________________________________________________| Salivary Glands | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Stomach, Forestomach | + + + + + + + + + + + + + + + + + + + + + + + + +| Hyperkeratosis | 2 2 | Hyperplasia, Basal Cell | 1 2 | Necrosis | 3 | Ulcer | 2 3 | __________________________________________________________________________| Stomach, Glandular | + + + + + + + + + + + + + + + + + + + + + + + + +| Hyperplasia | | Inflammation, Chronic Active | | Mineralization | 2 | __________________________________________________________________________| Tongue | + | Inflammation, Acute | 3 | _____________________________________________________________________________________________________________________| CARDIOVASCULAR SYSTEM | | | | __________________________________________________________________________| Heart | + + + + + + + + + + + + + + + + + + + + + + + + +| Cardiomyopathy | 2 2 2 2 2 2 2 2 3 2 3 2 2 2 2 2 2 2 2 2 2 2 | _____________________________________________________________________________________________________________________| ENDOCRINE SYSTEM | | | | _____________________________________________________________________________________________________________________| Page 39 NTP Experiment-Test: 05108-01 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:43:56 _____________________________________________________________________________________________________________________ | 7| 6| 6| 4| 4| 7| 6| 6| 4| 4| 7| 7| 7| 6| 5| 7| 7| 7| 6| 1| 7| 7| 6| 5| 4| DAY ON TEST | 3| 7| 0| 6| 6| 3| 8| 4| 6| 6| 3| 3| 3| 8| 8| 3| 3| 3| 8| 7| 3| 0| 9| 7| 6| | 0| 1| 2| 3| 2| 0| 7| 1| 3| 2| 0| 0| 0| 4| 4| 0| 0| 0| 6| 0| 0| 3| 7| 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| FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| VEHICLE | 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 5| 5| 5| 5| 5| MALE | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| _____________________________________________________________________________________________________________________| ENDOCRINE SYSTEM - cont | | | | __________________________________________________________________________| Adrenal Cortex | + + + + + + + + + + + + + + + + + + + + + + + + +| Hypertrophy | 2 | __________________________________________________________________________| Adrenal Medulla | + + + + + + + + + + + + + + + + + + + + + + + + +| Hyperplasia | 3 2 1 2 1 2 | Bilateral, Hyperplasia | 2 2 | __________________________________________________________________________| Islets, Pancreatic | + + + + + + + + + + + + + + + + + + + + + + + + +| Hyperplasia | | __________________________________________________________________________| Parathyroid Gland | + + + + + + + + M + + + + + + + + + + M + + + + +| Hyperplasia | 3 | Bilateral, Hyperplasia | 2 | __________________________________________________________________________| Pituitary Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| Pars Distalis, Angiectasis | 2 3 2 3 2 | Pars Distalis, Cyst | X X X | Pars Distalis, Hyperplasia | 1 1 2 2 2 3 2 2 3 2 2| __________________________________________________________________________| Thyroid Gland | + + + + + + + + + + + + + + + + + + + A + + + + +| C-Cell, Hyperplasia | 2 1 1 2 | Follicular Cell, Hyperplasia | 2 | _____________________________________________________________________________________________________________________| GENERAL BODY SYSTEM | | | | None | | _____________________________________________________________________________________________________________________| GENITAL SYSTEM | | | | __________________________________________________________________________| Epididymis | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Preputial Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| Necrosis | 3 | __________________________________________________________________________| Prostate | + + + + + + + + + + + + + + + + + + + + + + + + +| Inflammation, Chronic Active | 2 | __________________________________________________________________________| Seminal Vesicle | + + + + + + + + + + + + + + + + + + + + + + + + +| Inflammation, Acute | | __________________________________________________________________________| Testes | + + + + + + + + + + + + + + + + + + + + + + + + +| Atrophy | | Interstitial Cell, Hyperplasia | 2 2 2 2 2 2| Seminiferous Tubule, Atrophy | 3 1 3 2 3 | _____________________________________________________________________________________________________________________| HEMATOPOIETIC SYSTEM | | | | __________________________________________________________________________| Blood | + + + + | __________________________________________________________________________| Bone Marrow | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Lymph Node | + + + | Mediastinal, Angiectasis | | Pancreatic, Pigmentation | | __________________________________________________________________________| Lymph Node, Mandibular | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Lymph Node, Mesenteric | + + + + + + + + + + + + + + + + + + + + + + + + +| Degeneration | | __________________________________________________________________________| Spleen | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| Page 40 NTP Experiment-Test: 05108-01 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:43:56 _____________________________________________________________________________________________________________________ | 7| 6| 6| 4| 4| 7| 6| 6| 4| 4| 7| 7| 7| 6| 5| 7| 7| 7| 6| 1| 7| 7| 6| 5| 4| DAY ON TEST | 3| 7| 0| 6| 6| 3| 8| 4| 6| 6| 3| 3| 3| 8| 8| 3| 3| 3| 8| 7| 3| 0| 9| 7| 6| | 0| 1| 2| 3| 2| 0| 7| 1| 3| 2| 0| 0| 0| 4| 4| 0| 0| 0| 6| 0| 0| 3| 7| 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| FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| VEHICLE | 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 5| 5| 5| 5| 5| MALE | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| _____________________________________________________________________________________________________________________| HEMATOPOIETIC SYSTEM - cont | | | | Fibrosis | 2 | Hematopoietic Cell Proliferation | 2 | Infarct | 4 | __________________________________________________________________________| Thymus | + + + + + M + + + + + + + M M + + + M + + + M + +| Cyst | X | Epithelial Cell, Hyperplasia | 2 2 | _____________________________________________________________________________________________________________________| INTEGUMENTARY SYSTEM | | | | __________________________________________________________________________| Mammary Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Skin | + + + + + + + + + + + + + + + + + + + + + + + + +| Abscess | 4 | Cyst Epithelial Inclusion | X | Hyperkeratosis | | _____________________________________________________________________________________________________________________| MUSCULOSKELETAL SYSTEM | | | | __________________________________________________________________________| Bone | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Skeletal Muscle | | _____________________________________________________________________________________________________________________| NERVOUS SYSTEM | | | | __________________________________________________________________________| Brain | + + + + + + + + + + + + + + + + + + + + + + + + +| Hemorrhage | 1 | Mineralization | 1 | Thrombosis | | __________________________________________________________________________| Peripheral Nerve | + | Degeneration | 1 | Inflammation, Chronic Active | 1 | __________________________________________________________________________| Spinal Cord | + | _____________________________________________________________________________________________________________________| RESPIRATORY SYSTEM | | | | __________________________________________________________________________| Lung | + + + + + + + + + + + + + + + + + + + + + + + + +| Hemorrhage | 2 1 | Infiltration Cellular, Histiocyte | 2 2 | Inflammation, Acute | 2 | Alveolar Epithelium, Hyperplasia | 2 3 | Bronchiole, Inflammation, Acute | | __________________________________________________________________________| Nose | + + + + + + + + + + + + + + + + + + + + + + + + +| Fungus | 2 | Hyperkeratosis | 3 | Inflammation, Acute | 3 1 1 2 2 | __________________________________________________________________________| Trachea | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| SPECIAL SENSES SYSTEM | | | | __________________________________________________________________________| Ear | | __________________________________________________________________________| Eye | + | _____________________________________________________________________________________________________________________| Page 41 NTP Experiment-Test: 05108-01 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:43:56 _____________________________________________________________________________________________________________________ | 7| 6| 6| 4| 4| 7| 6| 6| 4| 4| 7| 7| 7| 6| 5| 7| 7| 7| 6| 1| 7| 7| 6| 5| 4| DAY ON TEST | 3| 7| 0| 6| 6| 3| 8| 4| 6| 6| 3| 3| 3| 8| 8| 3| 3| 3| 8| 7| 3| 0| 9| 7| 6| | 0| 1| 2| 3| 2| 0| 7| 1| 3| 2| 0| 0| 0| 4| 4| 0| 0| 0| 6| 0| 0| 3| 7| 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| FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| VEHICLE | 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 5| 5| 5| 5| 5| MALE | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| _____________________________________________________________________________________________________________________| SPECIAL SENSES SYSTEM - cont | | | | Atrophy | | __________________________________________________________________________| Harderian Gland | + | _____________________________________________________________________________________________________________________| URINARY SYSTEM | | | | __________________________________________________________________________| Kidney | + + + + + + + + + + + + + + + + + + + + + + + + +| Cyst | X | Developmental Malformation | | Mineralization | 1 | Nephropathy | 3 4 2 2 2 2 3 3 2 2 3 3 3 3 2 3 3 3 2 3 3 4 3 2| Pelvis, Transitional Epithelium, | | Hyperplasia | | Pelvis, Transitional Epithelium, | | Inflammation | | __________________________________________________________________________| Urinary Bladder | + + + + + + + + + + + + + + + + + + + + + + + + +| Calculus Gross Observation | | Calculus Micro Observation Only | | Hemorrhage | 1 | _____________________________________________________________________________________________________________________| Page 42 NTP Experiment-Test: 05108-01 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:43:56 _____________________________________________________________________________________________________________________ | 7| 7| 6| 6| 5| 7| 7| 6| 4| 4| 7| 7| 7| 7| 7| 7| 7| 7| 5| 4| 7| 6| 6| 4| 4| DAY ON TEST | 3| 1| 8| 7| 9| 3| 3| 3| 6| 6| 3| 3| 3| 3| 3| 3| 3| 3| 1| 6| 3| 8| 7| 6| 6| | 0| 6| 6| 3| 5| 0| 0| 2| 3| 2| 0| 0| 0| 0| 0| 0| 0| 0| 2| 2| 0| 6| 1| 3| 3| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| VEHICLE | 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 0| 0| 0| 0| 0| MALE | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| _____________________________________________________________________________________________________________________| ALIMENTARY SYSTEM | | | | __________________________________________________________________________| Esophagus | + + + + + + + + + + + + + + + + + + + + + + + + +| Inflammation, Acute | | __________________________________________________________________________| 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 | + + + + + + + + + + + + + + + + + + + + + + + + +| Angiectasis | | Basophilic Focus | X X 1 X X 1 X X X X X | Clear Cell Focus | X X X X | Degeneration, Cystic | 2 1 | Eosinophilic Focus | X | Fatty Change, Diffuse | 1 1 1 1 1 1| Hepatodiaphragmatic Nodule | X X X X X X X X| Hyperplasia | 3 | Leukocytosis | 3 | Mixed Cell Focus | X | Necrosis, Focal | 1 | Bile Duct, Hyperplasia | 2 2 2 2 1 1 3 1 2 1 1 2 1 1 1 2 3 1 1| __________________________________________________________________________| Mesentery | + | Fat, Mineralization | | __________________________________________________________________________| Pancreas | + + + + + + + + + + + + + + + + + + + + + + + +| Acinus, Hyperplasia | 3 | Artery, Inflammation, Chronic Active | 2 | __________________________________________________________________________| Salivary Glands | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Stomach, Forestomach | + + + + + + + + + + + M + + + + + + + + + + + + +| Hyperkeratosis | | Hyperplasia, Basal Cell | | Necrosis | | Ulcer | 1 | __________________________________________________________________________| Stomach, Glandular | + + + + + + + + + + + + + + + + + + A + + + + + +| Hyperplasia | 1| Inflammation, Chronic Active | 1 | Mineralization | | __________________________________________________________________________| Tongue | | Inflammation, Acute | | _____________________________________________________________________________________________________________________| CARDIOVASCULAR SYSTEM | | | | __________________________________________________________________________| Heart | + + + + + + + + + + + + + + + + + + + + + + + + +| Cardiomyopathy | 2 2 2 2 2 2 2 2 2 2 2 2 2 3 2 2 2 2 2 2 2 2 2| _____________________________________________________________________________________________________________________| ENDOCRINE SYSTEM | | | | _____________________________________________________________________________________________________________________| Page 43 NTP Experiment-Test: 05108-01 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:43:56 _____________________________________________________________________________________________________________________ | 7| 7| 6| 6| 5| 7| 7| 6| 4| 4| 7| 7| 7| 7| 7| 7| 7| 7| 5| 4| 7| 6| 6| 4| 4| DAY ON TEST | 3| 1| 8| 7| 9| 3| 3| 3| 6| 6| 3| 3| 3| 3| 3| 3| 3| 3| 1| 6| 3| 8| 7| 6| 6| | 0| 6| 6| 3| 5| 0| 0| 2| 3| 2| 0| 0| 0| 0| 0| 0| 0| 0| 2| 2| 0| 6| 1| 3| 3| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| VEHICLE | 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 0| 0| 0| 0| 0| MALE | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| _____________________________________________________________________________________________________________________| ENDOCRINE SYSTEM - cont | | | | __________________________________________________________________________| Adrenal Cortex | + + + + + + + + + + + + + + + + + + + + + + + + +| Hypertrophy | 2 | __________________________________________________________________________| Adrenal Medulla | + + + + + + + + + + + + + + + + + + + + + + + + +| Hyperplasia | 2 2 1 1 2 | Bilateral, Hyperplasia | | __________________________________________________________________________| Islets, Pancreatic | + + + + + + + + + + + + + + + + + + + + + + + + +| Hyperplasia | 2 | __________________________________________________________________________| Parathyroid Gland | + M + + + + + + + + + + + + + + + + + M + + + + +| Hyperplasia | | Bilateral, Hyperplasia | | __________________________________________________________________________| Pituitary Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| Pars Distalis, Angiectasis | 2 3 1 1 2 | Pars Distalis, Cyst | X | Pars Distalis, Hyperplasia | 2 1 2 3 2 2 2 2 2 | __________________________________________________________________________| Thyroid Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| C-Cell, Hyperplasia | 1 1 1 1 | Follicular Cell, Hyperplasia | 2 | _____________________________________________________________________________________________________________________| GENERAL BODY SYSTEM | | | | None | | _____________________________________________________________________________________________________________________| GENITAL SYSTEM | | | | __________________________________________________________________________| Epididymis | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Preputial Gland | + + M + + + + + + + + + + + + + + + + + + + + + +| Necrosis | | __________________________________________________________________________| Prostate | + + M + + + + + + + + + + + + + + + + + + + + + +| Inflammation, Chronic Active | | __________________________________________________________________________| Seminal Vesicle | + + M + + + + + + + + + + + + + + + + + + + + + +| Inflammation, Acute | | __________________________________________________________________________| Testes | + + + + + + + + + + + + + + + + + + + + + + + + +| Atrophy | 3 | Interstitial Cell, Hyperplasia | 1 2 2 2 2 2 2 2| Seminiferous Tubule, Atrophy | 3 4 2 | _____________________________________________________________________________________________________________________| HEMATOPOIETIC SYSTEM | | | | __________________________________________________________________________| Blood | + + + + | __________________________________________________________________________| Bone Marrow | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Lymph Node | + + + + + + + | Mediastinal, Angiectasis | | Pancreatic, Pigmentation | 2 | __________________________________________________________________________| Lymph Node, Mandibular | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Lymph Node, Mesenteric | + M + + + + + + + + + + + + + + + + + + + + + + +| Degeneration | 3 | __________________________________________________________________________| Spleen | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| Page 44 NTP Experiment-Test: 05108-01 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:43:56 _____________________________________________________________________________________________________________________ | 7| 7| 6| 6| 5| 7| 7| 6| 4| 4| 7| 7| 7| 7| 7| 7| 7| 7| 5| 4| 7| 6| 6| 4| 4| DAY ON TEST | 3| 1| 8| 7| 9| 3| 3| 3| 6| 6| 3| 3| 3| 3| 3| 3| 3| 3| 1| 6| 3| 8| 7| 6| 6| | 0| 6| 6| 3| 5| 0| 0| 2| 3| 2| 0| 0| 0| 0| 0| 0| 0| 0| 2| 2| 0| 6| 1| 3| 3| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| VEHICLE | 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 0| 0| 0| 0| 0| MALE | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| _____________________________________________________________________________________________________________________| HEMATOPOIETIC SYSTEM - cont | | | | Fibrosis | 3 | Hematopoietic Cell Proliferation | | Infarct | | __________________________________________________________________________| Thymus | + + + + + + + M M + + + + + + + + + + + + + + + +| Cyst | | Epithelial Cell, Hyperplasia | | _____________________________________________________________________________________________________________________| INTEGUMENTARY SYSTEM | | | | __________________________________________________________________________| Mammary Gland | + + + + + + + + + + + + + + + + + + + + + + + + M| __________________________________________________________________________| Skin | + + + + + + + + + + + + + + + + + + + + + + + + +| Abscess | | Cyst Epithelial Inclusion | | Hyperkeratosis | 3 3 | _____________________________________________________________________________________________________________________| MUSCULOSKELETAL SYSTEM | | | | __________________________________________________________________________| Bone | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Skeletal Muscle | + | _____________________________________________________________________________________________________________________| NERVOUS SYSTEM | | | | __________________________________________________________________________| Brain | + + + + + + + + + + + + + + + + + + + + + + + + +| Hemorrhage | 3 | Mineralization | | Thrombosis | 2 | __________________________________________________________________________| Peripheral Nerve | | Degeneration | | Inflammation, Chronic Active | | __________________________________________________________________________| Spinal Cord | | _____________________________________________________________________________________________________________________| RESPIRATORY SYSTEM | | | | __________________________________________________________________________| Lung | + + + + + + + + + + + + + + + + + + + + + + + + +| Hemorrhage | | Infiltration Cellular, Histiocyte | | Inflammation, Acute | | Alveolar Epithelium, Hyperplasia | 2 | Bronchiole, Inflammation, Acute | | __________________________________________________________________________| Nose | + + + + + + + + + + + + + + + + + + + + + + + + +| Fungus | 2 2 2 | Hyperkeratosis | | Inflammation, Acute | 2 1 1 2 2 | __________________________________________________________________________| Trachea | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| SPECIAL SENSES SYSTEM | | | | __________________________________________________________________________| Ear | + | __________________________________________________________________________| Eye | + | _____________________________________________________________________________________________________________________| Page 45 NTP Experiment-Test: 05108-01 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:43:56 _____________________________________________________________________________________________________________________ | 7| 7| 6| 6| 5| 7| 7| 6| 4| 4| 7| 7| 7| 7| 7| 7| 7| 7| 5| 4| 7| 6| 6| 4| 4| DAY ON TEST | 3| 1| 8| 7| 9| 3| 3| 3| 6| 6| 3| 3| 3| 3| 3| 3| 3| 3| 1| 6| 3| 8| 7| 6| 6| | 0| 6| 6| 3| 5| 0| 0| 2| 3| 2| 0| 0| 0| 0| 0| 0| 0| 0| 2| 2| 0| 6| 1| 3| 3| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| VEHICLE | 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 0| 0| 0| 0| 0| MALE | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| _____________________________________________________________________________________________________________________| SPECIAL SENSES SYSTEM - cont | | | | Atrophy | 4 | __________________________________________________________________________| Harderian Gland | | _____________________________________________________________________________________________________________________| URINARY SYSTEM | | | | __________________________________________________________________________| Kidney | + + + + + + + + + + + + + + + + + + + + + + + + +| Cyst | X X | Developmental Malformation | | Mineralization | | Nephropathy | 3 2 2 3 1 3 3 2 2 1 3 3 3 3 3 3 2 3 1 2 2 3 3 1 2| Pelvis, Transitional Epithelium, | | Hyperplasia | 2 | Pelvis, Transitional Epithelium, | | Inflammation | 3 | __________________________________________________________________________| Urinary Bladder | + + M + + + + + + + + + + + + + + + + + + + + + +| Calculus Gross Observation | X | Calculus Micro Observation Only | X | Hemorrhage | | _____________________________________________________________________________________________________________________| Page 46 NTP Experiment-Test: 05108-01 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:43:56 __________________________________________________________________________________________________________________________________ | 6| 6| 6| 5| 5| 7| 7| 6| 6| 6| | | DAY ON TEST | 9| 8| 1| 8| 6| 3| 3| 9| 6| 1| | | | 1| 6| 2| 2| 1| 0| 0| 7| 0| 0| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| | A | VEHICLE | 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| | L | MALE | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| | | __________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM | | | | | | __________________________________________________________________________|____________| Esophagus | + + + + + + + + + + | 60 | Inflammation, Acute | | 1 2.0| __________________________________________________________________________|____________| Intestine Large, Colon | + + + + + + + + + + | 59 | __________________________________________________________________________|____________| Intestine Large, Rectum | + + + + A + + + + + | 57 | __________________________________________________________________________|____________| Intestine Large, Cecum | + + + + A + + + + + | 57 | __________________________________________________________________________|____________| Intestine Small, Duodenum | + + + + + + + + + + | 59 | __________________________________________________________________________|____________| Intestine Small, Jejunum | + + + + A + + + + + | 57 | __________________________________________________________________________|____________| Intestine Small, Ileum | + + + + A + + + + + | 56 | __________________________________________________________________________|____________| Liver | + + + + + + + + + + | 60 | Angiectasis | 3 1 | 2 2.0| Basophilic Focus | X 1 X | 20 1.0| Clear Cell Focus | | 8 | Degeneration, Cystic | | 5 1.6| Eosinophilic Focus | X | 2 | Fatty Change, Diffuse | 1 1 | 13 1.0| Hepatodiaphragmatic Nodule | X | 11 | Hyperplasia | | 1 3.0| Leukocytosis | | 1 3.0| Mixed Cell Focus | | 4 | Necrosis, Focal | | 1 1.0| Bile Duct, Hyperplasia | 2 2 3 2 2 1 2 1 2 | 46 1.6| __________________________________________________________________________|____________| Mesentery | | 2 | Fat, Mineralization | | 1 2.0| __________________________________________________________________________|____________| Pancreas | + + + + + + + + + + | 59 | Acinus, Hyperplasia | | 2 3.0| Artery, Inflammation, Chronic Active | | 1 2.0| __________________________________________________________________________|____________| Salivary Glands | + + + + + + + + + + | 60 | __________________________________________________________________________|____________| Stomach, Forestomach | + + + + + + + + + + | 59 | Hyperkeratosis | | 2 2.0| Hyperplasia, Basal Cell | 1 2 1 | 5 1.4| Necrosis | 3 3 | 3 3.0| Ulcer | 2 | 4 2.0| __________________________________________________________________________|____________| Stomach, Glandular | + + + + + + + + + + | 59 | Hyperplasia | | 1 1.0| Inflammation, Chronic Active | | 1 1.0| Mineralization | | 1 2.0| __________________________________________________________________________|____________| Tongue | | 1 | Inflammation, Acute | | 1 3.0| _____________________________________________________________________________________________________________________| | CARDIOVASCULAR 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 47 NTP Experiment-Test: 05108-01 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:43:56 __________________________________________________________________________________________________________________________________ | 6| 6| 6| 5| 5| 7| 7| 6| 6| 6| | | DAY ON TEST | 9| 8| 1| 8| 6| 3| 3| 9| 6| 1| | | | 1| 6| 2| 2| 1| 0| 0| 7| 0| 0| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| | A | VEHICLE | 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| | L | MALE | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| | | __________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM - cont | | | | | | | | | __________________________________________________________________________|____________| Heart | + + + + + + + + + + | 60 | Cardiomyopathy | 3 2 2 2 2 3 2 2 | 53 2.1| _____________________________________________________________________________________________________________________| | ENDOCRINE SYSTEM | | | | | | __________________________________________________________________________|____________| Adrenal Cortex | + + + + + + + + + + | 60 | Hypertrophy | | 2 2.0| __________________________________________________________________________|____________| Adrenal Medulla | + + + + + + + + + + | 60 | Hyperplasia | 1 2 | 13 1.7| Bilateral, Hyperplasia | | 2 2.0| __________________________________________________________________________|____________| Islets, Pancreatic | + + + + + + + + + + | 60 | Hyperplasia | | 1 2.0| __________________________________________________________________________|____________| Parathyroid Gland | + + + + + + + + + + | 56 | Hyperplasia | | 1 3.0| Bilateral, Hyperplasia | | 1 2.0| __________________________________________________________________________|____________| Pituitary Gland | + + + + + + + + + + | 60 | Pars Distalis, Angiectasis | 2 2 | 12 2.1| Pars Distalis, Cyst | | 4 | Pars Distalis, Hyperplasia | 2 2 | 22 2.0| __________________________________________________________________________|____________| Thyroid Gland | + + + + + + + + + + | 59 | C-Cell, Hyperplasia | 2 | 9 1.3| Follicular Cell, Hyperplasia | 2 | 3 2.0| _____________________________________________________________________________________________________________________| | GENERAL BODY SYSTEM | | | | | | None | | | _____________________________________________________________________________________________________________________| | GENITAL SYSTEM | | | | | | __________________________________________________________________________|____________| Epididymis | + + + + + + + + + + | 60 | __________________________________________________________________________|____________| Preputial Gland | + + + + + + + + + M | 58 | Necrosis | | 1 3.0| __________________________________________________________________________|____________| Prostate | + + + + + M + + + + | 58 | Inflammation, Chronic Active | 4 | 2 3.0| __________________________________________________________________________|____________| Seminal Vesicle | + + + + + + + + + + | 59 | Inflammation, Acute | 4 | 1 4.0| __________________________________________________________________________|____________| Testes | + + + + + + + + + + | 60 | Atrophy | | 1 3.0| Interstitial Cell, Hyperplasia | | 14 1.9| Seminiferous Tubule, Atrophy | 3 3 4 3 2 | 13 2.8| _____________________________________________________________________________________________________________________| | HEMATOPOIETIC SYSTEM | | | __________________________________________________________________________________________________________________________________ * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 48 NTP Experiment-Test: 05108-01 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:43:56 __________________________________________________________________________________________________________________________________ | 6| 6| 6| 5| 5| 7| 7| 6| 6| 6| | | DAY ON TEST | 9| 8| 1| 8| 6| 3| 3| 9| 6| 1| | | | 1| 6| 2| 2| 1| 0| 0| 7| 0| 0| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| | A | VEHICLE | 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| | L | MALE | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| | | __________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - cont | | | | | | | | | __________________________________________________________________________|____________| Blood | + + + | 11 | __________________________________________________________________________|____________| Bone Marrow | + + + + + + + + + + | 60 | __________________________________________________________________________|____________| Lymph Node | + + + + + | 15 | Mediastinal, Angiectasis | 3 | 1 3.0| Pancreatic, Pigmentation | | 1 2.0| __________________________________________________________________________|____________| Lymph Node, Mandibular | + + + + + + + + + + | 60 | __________________________________________________________________________|____________| Lymph Node, Mesenteric | + + + + + + + + + + | 59 | Degeneration | | 1 3.0| __________________________________________________________________________|____________| Spleen | + + + + + + + + + + | 60 | Fibrosis | 2 | 3 2.3| Hematopoietic Cell Proliferation | 3 | 2 2.5| Infarct | | 1 4.0| __________________________________________________________________________|____________| Thymus | + M + + + + M + + + | 51 | Cyst | | 1 | Epithelial Cell, Hyperplasia | 1 | 3 1.7| _____________________________________________________________________________________________________________________| | INTEGUMENTARY SYSTEM | | | | | | __________________________________________________________________________|____________| Mammary Gland | + + + M + + + + + + | 58 | __________________________________________________________________________|____________| Skin | + + + + + + + + + + | 60 | Abscess | | 1 4.0| Cyst Epithelial Inclusion | | 1 | Hyperkeratosis | | 2 3.0| _____________________________________________________________________________________________________________________| | MUSCULOSKELETAL SYSTEM | | | | | | __________________________________________________________________________|____________| Bone | + + + + + + + + + + | 60 | __________________________________________________________________________|____________| Skeletal Muscle | | 1 | _____________________________________________________________________________________________________________________| | NERVOUS SYSTEM | | | | | | __________________________________________________________________________|____________| Brain | + + + + + + + + + + | 60 | Hemorrhage | | 2 2.0| Mineralization | | 1 1.0| Thrombosis | | 1 2.0| __________________________________________________________________________|____________| Peripheral Nerve | | 1 | Degeneration | | 1 1.0| Inflammation, Chronic Active | | 1 1.0| __________________________________________________________________________|____________| Spinal Cord | | 1 | _____________________________________________________________________________________________________________________| | RESPIRATORY SYSTEM | | | | | | __________________________________________________________________________________________________________________________________ * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 49 NTP Experiment-Test: 05108-01 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:43:56 __________________________________________________________________________________________________________________________________ | 6| 6| 6| 5| 5| 7| 7| 6| 6| 6| | | DAY ON TEST | 9| 8| 1| 8| 6| 3| 3| 9| 6| 1| | | | 1| 6| 2| 2| 1| 0| 0| 7| 0| 0| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| | A | VEHICLE | 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| | L | MALE | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| | | __________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM - cont | | | | | | __________________________________________________________________________|____________| Lung | + + + + + + + + + + | 60 | Hemorrhage | 1 | 3 1.3| Infiltration Cellular, Histiocyte | | 2 2.0| Inflammation, Acute | | 1 2.0| Alveolar Epithelium, Hyperplasia | | 3 2.3| Bronchiole, Inflammation, Acute | 1 | 1 1.0| __________________________________________________________________________|____________| Nose | + + + + + + + + + + | 60 | Fungus | 2 2 1 | 7 1.9| Hyperkeratosis | | 1 3.0| Inflammation, Acute | 2 1 3 | 13 1.8| __________________________________________________________________________|____________| Trachea | + + + + + + + + + + | 60 | _____________________________________________________________________________________________________________________| | SPECIAL SENSES SYSTEM | | | | | | __________________________________________________________________________|____________| Ear | | 1 | __________________________________________________________________________|____________| Eye | | 2 | Atrophy | | 1 4.0| __________________________________________________________________________|____________| Harderian Gland | | 1 | _____________________________________________________________________________________________________________________| | URINARY SYSTEM | | | | | | __________________________________________________________________________|____________| Kidney | + + + + + + + + + + | 60 | Cyst | | 3 | Developmental Malformation | X | 1 | Mineralization | 1 | 2 1.0| Nephropathy | 3 2 3 2 2 3 4 4 4 2 | 59 2.6| Pelvis, Transitional Epithelium, | | | Hyperplasia | | 1 2.0| Pelvis, Transitional Epithelium, | | | Inflammation | | 1 3.0| __________________________________________________________________________|____________| Urinary Bladder | + + + + + + + + + + | 59 | Calculus Gross Observation | | 1 | Calculus Micro Observation Only | | 1 | Hemorrhage | | 1 1.0| __________________________________________________________________________________________________________________________________ * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 50 NTP Experiment-Test: 05108-01 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:43:56 _____________________________________________________________________________________________________________________ | 7| 7| 6| 6| 4| 7| 7| 5| 4| 4| 7| 6| 5| 5| 4| 7| 7| 7| 5| 5| 7| 6| 5| 4| 1| DAY ON TEST | 3| 3| 5| 4| 6| 3| 3| 8| 6| 6| 3| 8| 5| 2| 6| 3| 3| 1| 7| 6| 3| 5| 2| 6| 9| | 0| 0| 5| 7| 3| 0| 0| 9| 3| 2| 0| 1| 5| 5| 3| 0| 0| 6| 8| 8| 0| 8| 9| 2| 2| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 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| 8.3 | 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| MG/KG | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| _____________________________________________________________________________________________________________________| ALIMENTARY SYSTEM | | | | __________________________________________________________________________| Esophagus | + + + + + + + + + + + + + + + + + + + + + + + + +| Hemorrhage | | Inflammation, Acute | 3| __________________________________________________________________________| Intestine Large, Colon | + + + + + + + + + + A + + + + + + + + + + + + + +| Artery, Inflammation, Chronic Active | 2 | __________________________________________________________________________| Intestine Large, Rectum | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Large, Cecum | + + + + + + + + + + A + + + + + + + + + + + + + A| __________________________________________________________________________| Intestine Small, Duodenum | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Small, Jejunum | + + + + + + + + + + A + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Small, Ileum | + + + + + + + + + + A + + + + + + + + + + + + + +| Necrosis | 2 | __________________________________________________________________________| Liver | + + + + + + + + + + + + + + + + + + + + + + + + +| Angiectasis | 2 2 2 1 | Basophilic Focus | X X 1 X X X 1 X 1 1 X 1 1 X X | Clear Cell Focus | 1 X X 1 | Degeneration, Cystic | 2 1 | Eosinophilic Focus | 2 1 1 | Fatty Change, Diffuse | 2 1 1 1 1 1 1 | Fibrosis | | Hepatodiaphragmatic Nodule | | Infarct | 2 | Mixed Cell Focus | | Necrosis, Focal | 1 | Thrombosis | 1 2 | Artery, Necrosis | 2 | Bile Duct, Hyperplasia | 1 3 3 3 1 2 3 1 2 3 3 2 1 2 3 2 | __________________________________________________________________________| Mesentery | + + + | Artery, Inflammation, Chronic Active | | Fat, Hemorrhage | 4 | Fat, Necrosis | | Fat, Pigmentation | 3 | __________________________________________________________________________| Pancreas | + + + + + + + + + + + + + + + + + + + + + + + + +| Acinus, Hyperplasia | 2 | Artery, Fibrosis | 3 | Artery, Inflammation, Chronic Active | 2 2 | __________________________________________________________________________| Salivary Glands | + + + + + + + + + + + + + + + + + + + + + + + + +| Duct, Metaplasia, Squamous | 1 1 | __________________________________________________________________________| Stomach, Forestomach | + + + + + + + + + + + + + + + + + + + + + + + + +| Hyperkeratosis | 2 | Hyperplasia, Basal Cell | 2 | Hyperplasia, Squamous | | Mineralization | 2 | Necrosis | 3 | __________________________________________________________________________| Stomach, Glandular | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| Page 51 NTP Experiment-Test: 05108-01 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:43:56 _____________________________________________________________________________________________________________________ | 7| 7| 6| 6| 4| 7| 7| 5| 4| 4| 7| 6| 5| 5| 4| 7| 7| 7| 5| 5| 7| 6| 5| 4| 1| DAY ON TEST | 3| 3| 5| 4| 6| 3| 3| 8| 6| 6| 3| 8| 5| 2| 6| 3| 3| 1| 7| 6| 3| 5| 2| 6| 9| | 0| 0| 5| 7| 3| 0| 0| 9| 3| 2| 0| 1| 5| 5| 3| 0| 0| 6| 8| 8| 0| 8| 9| 2| 2| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 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| 8.3 | 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| MG/KG | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| _____________________________________________________________________________________________________________________| ALIMENTARY SYSTEM - cont | | | | Erosion | 2 | Mineralization | 2 2 1 2 2 | __________________________________________________________________________| Tongue | | _____________________________________________________________________________________________________________________| CARDIOVASCULAR SYSTEM | | | | __________________________________________________________________________| Heart | + + + + + + + + + + + + + + + + + + + + + + + + +| Cardiomyopathy | 2 2 2 2 2 2 2 2 2 2 2 2 | Inflammation, Acute | | Mineralization | 3 1 | Thrombosis | 3 | _____________________________________________________________________________________________________________________| ENDOCRINE SYSTEM | | | | __________________________________________________________________________| Adrenal Cortex | + + + + + + + + + + + + + + + + + + + + + + + + +| Hyperplasia | | __________________________________________________________________________| Adrenal Medulla | + + + + + + + + + + + + + + + + + + + + + + + + +| Hyperplasia | 1 2 2 2 1 | __________________________________________________________________________| Islets, Pancreatic | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Parathyroid Gland | + + + + + + + + + + + + + + + + + + + + + + + + M| Hyperplasia | 2 3 1 | __________________________________________________________________________| Pituitary Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| Pars Distalis, Angiectasis | 2 2 2 | Pars Distalis, Cyst | X | Pars Distalis, Hyperplasia | 2 2 2 2 2 3 | __________________________________________________________________________| Thyroid Gland | + + + + + + + + + + + + + + + + + + + + + + + + A| C-Cell, Hyperplasia | 1 | Follicle, Cyst | | _____________________________________________________________________________________________________________________| GENERAL BODY SYSTEM | | | | None | | _____________________________________________________________________________________________________________________| GENITAL SYSTEM | | | | __________________________________________________________________________| Epididymis | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Preputial Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| Hyperplasia | | Necrosis | 2 | __________________________________________________________________________| Prostate | + + + + + + + + + + + + + + + + + + + + + + + + +| Inflammation, Chronic Active | | __________________________________________________________________________| Seminal Vesicle | + + + + + + + + + + + + + + + + + + + + + + + + +| Inflammation, Acute | | __________________________________________________________________________| Testes | + + + + + + + + + + + + + + + + + + + + + + + + +| Interstitial Cell, Hyperplasia | 2 1 2 2 2 2 2 1 1 2 2 | Seminiferous Tubule, Atrophy | 3 3 | _____________________________________________________________________________________________________________________| HEMATOPOIETIC SYSTEM | | | | _____________________________________________________________________________________________________________________| Page 52 NTP Experiment-Test: 05108-01 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:43:56 _____________________________________________________________________________________________________________________ | 7| 7| 6| 6| 4| 7| 7| 5| 4| 4| 7| 6| 5| 5| 4| 7| 7| 7| 5| 5| 7| 6| 5| 4| 1| DAY ON TEST | 3| 3| 5| 4| 6| 3| 3| 8| 6| 6| 3| 8| 5| 2| 6| 3| 3| 1| 7| 6| 3| 5| 2| 6| 9| | 0| 0| 5| 7| 3| 0| 0| 9| 3| 2| 0| 1| 5| 5| 3| 0| 0| 6| 8| 8| 0| 8| 9| 2| 2| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 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| 8.3 | 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| MG/KG | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| _____________________________________________________________________________________________________________________| HEMATOPOIETIC SYSTEM - cont | | | | __________________________________________________________________________| Blood | + + + + + + + | __________________________________________________________________________| Bone Marrow | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Lymph Node | + + + + + + + | Renal, Angiectasis | | __________________________________________________________________________| Lymph Node, Mandibular | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Lymph Node, Mesenteric | + + + + + + + + + + + + + + + + + + + + + + + + +| Infiltration Cellular, Histiocyte | | __________________________________________________________________________| Spleen | + + + + + + + + + + + + + + + + + + + + + + + + +| Fibrosis | 2 2 2 1 | Hematopoietic Cell Proliferation | | Infarct | 3 | __________________________________________________________________________| Thymus | + + + + + + + + + M + + + + + M + + + + + M + + +| _____________________________________________________________________________________________________________________| INTEGUMENTARY SYSTEM | | | | __________________________________________________________________________| Mammary Gland | + + + + M + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Skin | + + + + + + + + + + + + + + + + + + + + + + + + +| Cyst Epithelial Inclusion | X | Necrosis | | _____________________________________________________________________________________________________________________| MUSCULOSKELETAL SYSTEM | | | | __________________________________________________________________________| Bone | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Skeletal Muscle | + + + | Necrosis | | _____________________________________________________________________________________________________________________| NERVOUS SYSTEM | | | | __________________________________________________________________________| Brain | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| RESPIRATORY SYSTEM | | | | __________________________________________________________________________| Lung | + + + + + + + + + + + + + + + + + + + + + + + + +| Edema | 2 | Fibrosis | 1 | Hemorrhage | 2 X 1 2 | Infiltration Cellular, Histiocyte | 3 2 | Inflammation, Acute | 1 | Alveolar Epithelium, Hyperplasia | | Artery, Inflammation, Chronic Active | | __________________________________________________________________________| Nose | + + + + + + + + + + + + + + + + + + + + + + + + +| Fungus | 2 3 | Hyperkeratosis | | Inflammation, Acute | 2 2 2| __________________________________________________________________________| Trachea | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| SPECIAL SENSES SYSTEM | | | | __________________________________________________________________________| Ear | | _____________________________________________________________________________________________________________________| Page 53 NTP Experiment-Test: 05108-01 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:43:56 _____________________________________________________________________________________________________________________ | 7| 7| 6| 6| 4| 7| 7| 5| 4| 4| 7| 6| 5| 5| 4| 7| 7| 7| 5| 5| 7| 6| 5| 4| 1| DAY ON TEST | 3| 3| 5| 4| 6| 3| 3| 8| 6| 6| 3| 8| 5| 2| 6| 3| 3| 1| 7| 6| 3| 5| 2| 6| 9| | 0| 0| 5| 7| 3| 0| 0| 9| 3| 2| 0| 1| 5| 5| 3| 0| 0| 6| 8| 8| 0| 8| 9| 2| 2| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 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| 8.3 | 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| MG/KG | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| _____________________________________________________________________________________________________________________| SPECIAL SENSES SYSTEM - cont | | | | __________________________________________________________________________| Eye | | Lens, Cataract | | _____________________________________________________________________________________________________________________| URINARY SYSTEM | | | | __________________________________________________________________________| Kidney | + + + + + + + + + + + + + + + + + + + + + + + + +| Cyst | X X X | Hemorrhage | 2 | Mineralization | 1 | Nephropathy | 3 2 2 4 2 3 4 2 3 2 4 3 1 1 1 3 3 3 4 1 4 3 1 1 | Renal Tubule, Hyperplasia | 2 | __________________________________________________________________________| Urinary Bladder | + + + + + + + + + + + + + + + + + + + + + + + + A| _____________________________________________________________________________________________________________________| Page 54 NTP Experiment-Test: 05108-01 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:43:56 _____________________________________________________________________________________________________________________ | 7| 7| 7| 4| 7| 7| 6| 5| 5| 4| 7| 6| 4| 4| 4| 7| 6| 6| 5| 2| 7| 6| 6| 5| 5| DAY ON TEST | 3| 3| 0| 9| 3| 2| 9| 8| 0| 6| 0| 4| 9| 6| 6| 2| 5| 2| 6| 5| 3| 5| 1| 6| 2| | 0| 0| 4| 1| 0| 4| 6| 9| 1| 3| 0| 1| 7| 3| 3| 9| 4| 3| 8| 9| 0| 6| 2| 3| 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| FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 8.3 | 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| MG/KG | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| _____________________________________________________________________________________________________________________| ALIMENTARY SYSTEM | | | | __________________________________________________________________________| Esophagus | + + + + + + + + + + + + + + + + + + + + + + + + +| Hemorrhage | | Inflammation, Acute | | __________________________________________________________________________| Intestine Large, Colon | + + + + + + + + + + + + A + + A + + + + + + + + +| Artery, Inflammation, Chronic Active | 2 | __________________________________________________________________________| Intestine Large, Rectum | + + + + + + + + + + + + A + + A + + + + + + + + +| __________________________________________________________________________| Intestine Large, Cecum | + + + + + + + + + + + + A + + A + + + + + + + + +| __________________________________________________________________________| Intestine Small, Duodenum | + + + + + + + + + + + + A + + A + + + + + + + + +| __________________________________________________________________________| Intestine Small, Jejunum | + + + + + + + + + + + + A + + A + + + + + + + + +| __________________________________________________________________________| Intestine Small, Ileum | + + + + + + + + + + + + A + + A + + + + + + + + +| Necrosis | | __________________________________________________________________________| Liver | + + + + + + + + + + + + + + + + + + + + + + + + +| Angiectasis | 1 2 2 | Basophilic Focus | X X X X X X 1 X X 1 | Clear Cell Focus | X X X | Degeneration, Cystic | 1 1 | Eosinophilic Focus | X | Fatty Change, Diffuse | 1 1 2 1 1 | Fibrosis | 2 | Hepatodiaphragmatic Nodule | X | Infarct | 4 | Mixed Cell Focus | X X | Necrosis, Focal | | Thrombosis | | Artery, Necrosis | | Bile Duct, Hyperplasia | 2 2 2 2 2 3 2 3 1 2 3 2 3 1 3 3 2| __________________________________________________________________________| Mesentery | + + + + | Artery, Inflammation, Chronic Active | 2 | Fat, Hemorrhage | 3 4 | Fat, Necrosis | 2 2 | Fat, Pigmentation | | __________________________________________________________________________| Pancreas | + + + + + + + + + + + + + + + + + + + + + + + + +| Acinus, Hyperplasia | | Artery, Fibrosis | | Artery, Inflammation, Chronic Active | | __________________________________________________________________________| Salivary Glands | + + + + + + + + + + + + + + + + + + + + + + + + +| Duct, Metaplasia, Squamous | | __________________________________________________________________________| Stomach, Forestomach | + + + + + + + + + + + + + + + + + + + + + + + + +| Hyperkeratosis | 3 2 | Hyperplasia, Basal Cell | 1 3 1 | Hyperplasia, Squamous | 3 | Mineralization | | Necrosis | 2 2 3 | __________________________________________________________________________| Stomach, Glandular | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| Page 55 NTP Experiment-Test: 05108-01 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:43:56 _____________________________________________________________________________________________________________________ | 7| 7| 7| 4| 7| 7| 6| 5| 5| 4| 7| 6| 4| 4| 4| 7| 6| 6| 5| 2| 7| 6| 6| 5| 5| DAY ON TEST | 3| 3| 0| 9| 3| 2| 9| 8| 0| 6| 0| 4| 9| 6| 6| 2| 5| 2| 6| 5| 3| 5| 1| 6| 2| | 0| 0| 4| 1| 0| 4| 6| 9| 1| 3| 0| 1| 7| 3| 3| 9| 4| 3| 8| 9| 0| 6| 2| 3| 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| FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 8.3 | 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| MG/KG | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| _____________________________________________________________________________________________________________________| ALIMENTARY SYSTEM - cont | | | | Erosion | | Mineralization | 2 2 2 | __________________________________________________________________________| Tongue | | _____________________________________________________________________________________________________________________| CARDIOVASCULAR SYSTEM | | | | __________________________________________________________________________| Heart | + + + + + + + + + + + + + + + + + + + + + + + + +| Cardiomyopathy | 2 2 2 2 3 2 2 2 2 2 2 1 2 2 2 3 2 2 2 2| Inflammation, Acute | | Mineralization | 2 1 | Thrombosis | | _____________________________________________________________________________________________________________________| ENDOCRINE SYSTEM | | | | __________________________________________________________________________| Adrenal Cortex | + + + + + + + + + + + + + + + + + + + + + + + + +| Hyperplasia | 3 | __________________________________________________________________________| Adrenal Medulla | + + + + + + + + + + + + + + + + + + + + + + + + +| Hyperplasia | 2 1 2 1 2 2 1 | __________________________________________________________________________| Islets, Pancreatic | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Parathyroid Gland | + + + + + + + + + + + + + + M + + + M + + + + + +| Hyperplasia | 2 3 3 | __________________________________________________________________________| Pituitary Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| Pars Distalis, Angiectasis | 3 2 3 2 | Pars Distalis, Cyst | X | Pars Distalis, Hyperplasia | 3 2 2 2 2 | __________________________________________________________________________| Thyroid Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| C-Cell, Hyperplasia | 1 | Follicle, Cyst | | _____________________________________________________________________________________________________________________| GENERAL BODY SYSTEM | | | | None | | _____________________________________________________________________________________________________________________| GENITAL SYSTEM | | | | __________________________________________________________________________| Epididymis | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Preputial Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| Hyperplasia | | Necrosis | | __________________________________________________________________________| Prostate | + + + + + + + + + + + + + + + + + + + + + + + + +| Inflammation, Chronic Active | 3 | __________________________________________________________________________| Seminal Vesicle | + + + + + + + + + + + + + + + + + + + + + + + + +| Inflammation, Acute | 1 | __________________________________________________________________________| Testes | + + + + + + + + + + + + + + + + + + + + + + + + +| Interstitial Cell, Hyperplasia | 2 2 2 2 2 2| Seminiferous Tubule, Atrophy | 3 3 3 | _____________________________________________________________________________________________________________________| HEMATOPOIETIC SYSTEM | | | | _____________________________________________________________________________________________________________________| Page 56 NTP Experiment-Test: 05108-01 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:43:56 _____________________________________________________________________________________________________________________ | 7| 7| 7| 4| 7| 7| 6| 5| 5| 4| 7| 6| 4| 4| 4| 7| 6| 6| 5| 2| 7| 6| 6| 5| 5| DAY ON TEST | 3| 3| 0| 9| 3| 2| 9| 8| 0| 6| 0| 4| 9| 6| 6| 2| 5| 2| 6| 5| 3| 5| 1| 6| 2| | 0| 0| 4| 1| 0| 4| 6| 9| 1| 3| 0| 1| 7| 3| 3| 9| 4| 3| 8| 9| 0| 6| 2| 3| 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| FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 8.3 | 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| MG/KG | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| _____________________________________________________________________________________________________________________| HEMATOPOIETIC SYSTEM - cont | | | | __________________________________________________________________________| Blood | + + + + | __________________________________________________________________________| Bone Marrow | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Lymph Node | + + + + + + + + +| Renal, Angiectasis | 2 | __________________________________________________________________________| Lymph Node, Mandibular | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Lymph Node, Mesenteric | + + + + + + + + + + + + + + + + + + + + + + + + +| Infiltration Cellular, Histiocyte | | __________________________________________________________________________| Spleen | + + + + + + + + + + + + + + + + + + + + + + + + +| Fibrosis | 2 | Hematopoietic Cell Proliferation | 3 | Infarct | | __________________________________________________________________________| Thymus | + + + + + + + + + + + + + M + + + + + + + + + + +| _____________________________________________________________________________________________________________________| INTEGUMENTARY SYSTEM | | | | __________________________________________________________________________| Mammary Gland | + + + M + + + + + + + + M M M + + + + + + M + + +| __________________________________________________________________________| Skin | + + + + + + + + + + + + + + + + + + + + + + + + +| Cyst Epithelial Inclusion | | Necrosis | 3 | _____________________________________________________________________________________________________________________| MUSCULOSKELETAL SYSTEM | | | | __________________________________________________________________________| Bone | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Skeletal Muscle | + + + | Necrosis | 4 | _____________________________________________________________________________________________________________________| NERVOUS SYSTEM | | | | __________________________________________________________________________| Brain | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| RESPIRATORY SYSTEM | | | | __________________________________________________________________________| Lung | + + + + + + + + + + + + + + + + + + + + + + + + +| Edema | 2 1 | Fibrosis | | Hemorrhage | 2 1 2 1 1 2 1| Infiltration Cellular, Histiocyte | 2 1 | Inflammation, Acute | 3 | Alveolar Epithelium, Hyperplasia | | Artery, Inflammation, Chronic Active | 1 | __________________________________________________________________________| Nose | + + + + + + + + + + + + + + + + + + + + + + + + +| Fungus | 2 2 2 | Hyperkeratosis | 2 | Inflammation, Acute | 2 1 1 2 1 2 2 | __________________________________________________________________________| Trachea | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| SPECIAL SENSES SYSTEM | | | | __________________________________________________________________________| Ear | | _____________________________________________________________________________________________________________________| Page 57 NTP Experiment-Test: 05108-01 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:43:56 _____________________________________________________________________________________________________________________ | 7| 7| 7| 4| 7| 7| 6| 5| 5| 4| 7| 6| 4| 4| 4| 7| 6| 6| 5| 2| 7| 6| 6| 5| 5| DAY ON TEST | 3| 3| 0| 9| 3| 2| 9| 8| 0| 6| 0| 4| 9| 6| 6| 2| 5| 2| 6| 5| 3| 5| 1| 6| 2| | 0| 0| 4| 1| 0| 4| 6| 9| 1| 3| 0| 1| 7| 3| 3| 9| 4| 3| 8| 9| 0| 6| 2| 3| 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| FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 8.3 | 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| MG/KG | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| _____________________________________________________________________________________________________________________| SPECIAL SENSES SYSTEM - cont | | | | __________________________________________________________________________| Eye | + + | Lens, Cataract | 2 | _____________________________________________________________________________________________________________________| URINARY SYSTEM | | | | __________________________________________________________________________| Kidney | + + + + + + + + + + + + + + + + + + + + + + + + +| Cyst | | Hemorrhage | | Mineralization | 2 2 1 | Nephropathy | 3 4 3 1 3 2 4 2 1 2 4 3 2 1 2 3 2 2 2 4 2 1 1| Renal Tubule, Hyperplasia | 4 4 | __________________________________________________________________________| Urinary Bladder | + + + + + + + + + + + + A + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| Page 58 NTP Experiment-Test: 05108-01 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:43:56 __________________________________________________________________________________________________________________________________ | 7| 7| 7| 6| 6| 7| 5| 4| 4| 1| | | DAY ON TEST | 3| 3| 2| 7| 7| 3| 7| 6| 6| 8| | | | 0| 0| 5| 5| 5| 0| 0| 2| 2| 4| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| | A | 8.3 | 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| | L | MG/KG | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| | | __________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM | | | | | | __________________________________________________________________________|____________| Esophagus | + + + + + + + + + + | 60 | Hemorrhage | 2 | 1 2.0| Inflammation, Acute | | 1 3.0| __________________________________________________________________________|____________| Intestine Large, Colon | + + + + + + + + + + | 57 | Artery, Inflammation, Chronic Active | | 2 2.0| __________________________________________________________________________|____________| Intestine Large, Rectum | + + + + + + + + + + | 58 | __________________________________________________________________________|____________| Intestine Large, Cecum | + + + + + + + + + + | 56 | __________________________________________________________________________|____________| Intestine Small, Duodenum | + + + + + + + + + + | 58 | __________________________________________________________________________|____________| Intestine Small, Jejunum | + + A + + + + + + + | 56 | __________________________________________________________________________|____________| Intestine Small, Ileum | + + + + + + + + + + | 57 | Necrosis | | 1 2.0| __________________________________________________________________________|____________| Liver | + + + + + + + + + + | 60 | Angiectasis | | 7 1.7| Basophilic Focus | X 1 1 1 1 X X | 32 1.0| Clear Cell Focus | | 7 1.0| Degeneration, Cystic | | 4 1.3| Eosinophilic Focus | 4 | 5 2.0| Fatty Change, Diffuse | 1 1 1 | 15 1.1| Fibrosis | | 1 2.0| Hepatodiaphragmatic Nodule | | 1 | Infarct | | 2 3.0| Mixed Cell Focus | X | 3 | Necrosis, Focal | | 1 1.0| Thrombosis | | 2 1.5| Artery, Necrosis | | 1 2.0| Bile Duct, Hyperplasia | 2 2 2 3 2 2 | 39 2.2| __________________________________________________________________________|____________| Mesentery | | 7 | Artery, Inflammation, Chronic Active | | 1 2.0| Fat, Hemorrhage | | 3 3.7| Fat, Necrosis | | 2 2.0| Fat, Pigmentation | | 1 3.0| __________________________________________________________________________|____________| Pancreas | + + + + + + + + + + | 60 | Acinus, Hyperplasia | | 1 2.0| Artery, Fibrosis | | 1 3.0| Artery, Inflammation, Chronic Active | 1 | 3 1.7| __________________________________________________________________________|____________| Salivary Glands | + + + + + + + + + + | 60 | Duct, Metaplasia, Squamous | | 2 1.0| __________________________________________________________________________|____________| Stomach, Forestomach | + + + + + + + + + + | 60 | Hyperkeratosis | 2 2 | 5 2.2| __________________________________________________________________________________________________________________________________ * : 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 59 NTP Experiment-Test: 05108-01 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:43:56 __________________________________________________________________________________________________________________________________ | 7| 7| 7| 6| 6| 7| 5| 4| 4| 1| | | DAY ON TEST | 3| 3| 2| 7| 7| 3| 7| 6| 6| 8| | | | 0| 0| 5| 5| 5| 0| 0| 2| 2| 4| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| | A | 8.3 | 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| | L | MG/KG | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| | | __________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - cont | | | | | | Hyperplasia, Basal Cell | 2 1 2 | 7 1.7| Hyperplasia, Squamous | | 1 3.0| Mineralization | | 1 2.0| Necrosis | 1 3 | 6 2.3| __________________________________________________________________________|____________| Stomach, Glandular | + + + + + + + + + + | 60 | Erosion | | 1 2.0| Mineralization | 1 1 | 10 1.7| __________________________________________________________________________|____________| Tongue | + | 1 | _____________________________________________________________________________________________________________________| | CARDIOVASCULAR SYSTEM | | | | | | __________________________________________________________________________|____________| Heart | + + + + + + + + + + | 60 | Cardiomyopathy | X 2 2 2 2 2 2 | 39 2.0| Inflammation, Acute | 1 | 1 1.0| Mineralization | X 2 | 6 1.8| Thrombosis | | 1 3.0| _____________________________________________________________________________________________________________________| | ENDOCRINE SYSTEM | | | | | | __________________________________________________________________________|____________| Adrenal Cortex | + + + + + + + + + + | 60 | Hyperplasia | 1 | 2 2.0| __________________________________________________________________________|____________| Adrenal Medulla | + + + + + + + + + + | 60 | Hyperplasia | 1 2 1 | 15 1.5| __________________________________________________________________________|____________| Islets, Pancreatic | + + + + + + + + + + | 60 | __________________________________________________________________________|____________| Parathyroid Gland | + + + + + + + + + + | 57 | Hyperplasia | 2 2 | 8 2.3| __________________________________________________________________________|____________| Pituitary Gland | + + + + + + + + + + | 60 | Pars Distalis, Angiectasis | | 7 2.3| Pars Distalis, Cyst | X | 3 | Pars Distalis, Hyperplasia | 2 2 2 | 14 2.1| __________________________________________________________________________|____________| Thyroid Gland | + + + + + + + + + + | 59 | C-Cell, Hyperplasia | | 2 1.0| Follicle, Cyst | X | 1 | _____________________________________________________________________________________________________________________| | GENERAL BODY SYSTEM | | | | | | None | | | _____________________________________________________________________________________________________________________| | GENITAL SYSTEM | | | | | | __________________________________________________________________________|____________| Epididymis | + + + + + + + + + + | 60 | __________________________________________________________________________|____________| Preputial Gland | + + + + + + + + + + | 60 | Hyperplasia | 2 2 | 2 2.0| __________________________________________________________________________________________________________________________________ * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 60 NTP Experiment-Test: 05108-01 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:43:56 __________________________________________________________________________________________________________________________________ | 7| 7| 7| 6| 6| 7| 5| 4| 4| 1| | | DAY ON TEST | 3| 3| 2| 7| 7| 3| 7| 6| 6| 8| | | | 0| 0| 5| 5| 5| 0| 0| 2| 2| 4| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| | A | 8.3 | 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| | L | MG/KG | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| | | __________________________________________________________________________________________________________________________________ GENITAL SYSTEM - cont | | | | | | Necrosis | | 1 2.0| __________________________________________________________________________|____________| Prostate | + + + + + + + + + + | 60 | Inflammation, Chronic Active | | 1 3.0| __________________________________________________________________________|____________| Seminal Vesicle | + + + + + + + + + + | 60 | Inflammation, Acute | | 1 1.0| __________________________________________________________________________|____________| Testes | + + + + + + + + + + | 60 | Interstitial Cell, Hyperplasia | 2 2 1 | 20 1.8| Seminiferous Tubule, Atrophy | | 5 3.0| _____________________________________________________________________________________________________________________| | HEMATOPOIETIC SYSTEM | | | | | | __________________________________________________________________________|____________| Blood | + | 12 | __________________________________________________________________________|____________| Bone Marrow | + + + + + + + + + + | 60 | __________________________________________________________________________|____________| Lymph Node | | 16 | Renal, Angiectasis | | 1 2.0| __________________________________________________________________________|____________| Lymph Node, Mandibular | + + + + + + + + + + | 60 | __________________________________________________________________________|____________| Lymph Node, Mesenteric | + + + + + + + + + + | 60 | Infiltration Cellular, Histiocyte | 2 | 1 2.0| __________________________________________________________________________|____________| Spleen | + + + + + + + + + + | 60 | Fibrosis | 3 | 6 2.0| Hematopoietic Cell Proliferation | | 1 3.0| Infarct | | 1 3.0| __________________________________________________________________________|____________| Thymus | M M + + + M + + + + | 53 | _____________________________________________________________________________________________________________________| | INTEGUMENTARY SYSTEM | | | | | | __________________________________________________________________________|____________| Mammary Gland | M + + + + + M + + + | 52 | __________________________________________________________________________|____________| Skin | + + + + + + + + + + | 60 | Cyst Epithelial Inclusion | | 1 | Necrosis | | 1 3.0| _____________________________________________________________________________________________________________________| | MUSCULOSKELETAL SYSTEM | | | | | | __________________________________________________________________________|____________| Bone | + + + + + + + + + + | 60 | __________________________________________________________________________|____________| Skeletal Muscle | | 6 | Necrosis | | 1 4.0| _____________________________________________________________________________________________________________________| | NERVOUS SYSTEM | | | | | | __________________________________________________________________________|____________| Brain | + + + + + + + + + + | 60 | _____________________________________________________________________________________________________________________| | RESPIRATORY SYSTEM | | | | | | __________________________________________________________________________|____________| Lung | + + + + + + + + + + | 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 61 NTP Experiment-Test: 05108-01 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:43:56 __________________________________________________________________________________________________________________________________ | 7| 7| 7| 6| 6| 7| 5| 4| 4| 1| | | DAY ON TEST | 3| 3| 2| 7| 7| 3| 7| 6| 6| 8| | | | 0| 0| 5| 5| 5| 0| 0| 2| 2| 4| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| | A | 8.3 | 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| | L | MG/KG | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| | | __________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM - cont | | | | | | Edema | 2 | 4 1.8| Fibrosis | | 1 1.0| Hemorrhage | | 11 1.5| Infiltration Cellular, Histiocyte | | 4 2.0| Inflammation, Acute | | 2 2.0| Alveolar Epithelium, Hyperplasia | 2 | 1 2.0| Artery, Inflammation, Chronic Active | | 1 1.0| __________________________________________________________________________|____________| Nose | + + + + + + + + + + | 60 | Fungus | | 5 2.2| Hyperkeratosis | | 1 2.0| Inflammation, Acute | 2 | 11 1.7| __________________________________________________________________________|____________| Trachea | + + + + + + + + + + | 60 | _____________________________________________________________________________________________________________________| | SPECIAL SENSES SYSTEM | | | | | | __________________________________________________________________________|____________| Ear | + | 1 | __________________________________________________________________________|____________| Eye | | 2 | Lens, Cataract | | 1 2.0| _____________________________________________________________________________________________________________________| | URINARY SYSTEM | | | | | | __________________________________________________________________________|____________| Kidney | + + + + + + + + + + | 60 | Cyst | | 3 | Hemorrhage | | 1 2.0| Mineralization | 2 3 | 6 1.8| Nephropathy | 2 3 4 4 3 4 2 2 2 | 56 2.5| Renal Tubule, Hyperplasia | 4 2 | 5 3.2| __________________________________________________________________________|____________| 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 62 NTP Experiment-Test: 05108-01 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:43:56 _____________________________________________________________________________________________________________________ | 7| 6| 5| 5| 4| 7| 6| 5| 5| 4| 7| 7| 6| 5| 4| 7| 7| 6| 4| 4| 7| 7| 6| 6| 5| DAY ON TEST | 2| 1| 9| 8| 6| 2| 6| 7| 2| 6| 2| 0| 6| 9| 7| 2| 0| 6| 6| 0| 2| 2| 7| 2| 5| | 5| 6| 7| 2| 3| 2| 5| 5| 0| 3| 5| 1| 6| 8| 9| 5| 0| 6| 2| 1| 5| 5| 3| 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| 0| FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 16.6 | 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| MG/KG | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| _____________________________________________________________________________________________________________________| ALIMENTARY SYSTEM | | | | __________________________________________________________________________| Esophagus | + + + + + + M + + + + + + + + + + + + + + + + + +| Hemorrhage | | Hyperkeratosis | | __________________________________________________________________________| Intestine Large, Colon | + + + + + + A + A + + + + A + + + + + + + + + + +| __________________________________________________________________________| Intestine Large, Rectum | + + A + + + A + A + + + + A + + A + + + + + + + +| __________________________________________________________________________| Intestine Large, Cecum | + + A + + + A + A + + + + A + + A + + + + + + + +| Hyperplasia | 2 | __________________________________________________________________________| Intestine Small, Duodenum | + + A + + + + + A + + + + A + + + + + + + + + + +| __________________________________________________________________________| Intestine Small, Jejunum | + + + + + A A + A + + + + A + + A + + + + + + + +| __________________________________________________________________________| Intestine Small, Ileum | + + A + + + A + A + + + + A + + A + + + + + + + +| __________________________________________________________________________| Liver | + + + + + + + + + + + + + + + + + + + + + + + + +| Angiectasis | 2 | Basophilic Focus | 2 1 X X X 1 2 | Clear Cell Focus | X X 1 2 1 | Degeneration, Cystic | 2 2 2 | Eosinophilic Focus | 4 3 X 1 | Fatty Change, Diffuse | 1 2 1 2 2 1 2 1 1 1 1| Hematopoietic Cell Proliferation | 2| Hepatodiaphragmatic Nodule | | Mixed Cell Focus | X X X | Necrosis | 1 3 2 | Bile Duct, Cyst | | Bile Duct, Hyperplasia | 2 1 1 3 2 2 1 1| Centrilobular, Hypertrophy | | __________________________________________________________________________| Mesentery | | Fat, Hemorrhage | | Fat, Mineralization | | Fat, Necrosis | | __________________________________________________________________________| Pancreas | + + + + + + + + M + + + + + + + + + + + + + + + +| __________________________________________________________________________| Salivary Glands | + + + + + + + + + + + + + + + + + + + + + + + + +| Duct, Metaplasia, Squamous | | __________________________________________________________________________| Stomach, Forestomach | + + + + + + + + + + + + + + + + + + + + + + + + +| Hyperkeratosis | 2 | Hyperplasia, Basal Cell | 2 1 | Inflammation, Acute | | Necrosis | 3 | Ulcer | 3 | __________________________________________________________________________| Stomach, Glandular | + + A + + + + + A + + + + A + + + + + + + + + + +| Mineralization | 2 2 | _____________________________________________________________________________________________________________________| CARDIOVASCULAR SYSTEM | | | | __________________________________________________________________________| Heart | + + + + + + + + + + + + + + + + + + + + + + + + +| Cardiomyopathy | 2 2 2 3 2 2 2 2 2 2 2 2 2 2 2 2 2 | Inflammation, Acute | | _____________________________________________________________________________________________________________________| Page 63 NTP Experiment-Test: 05108-01 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:43:56 _____________________________________________________________________________________________________________________ | 7| 6| 5| 5| 4| 7| 6| 5| 5| 4| 7| 7| 6| 5| 4| 7| 7| 6| 4| 4| 7| 7| 6| 6| 5| DAY ON TEST | 2| 1| 9| 8| 6| 2| 6| 7| 2| 6| 2| 0| 6| 9| 7| 2| 0| 6| 6| 0| 2| 2| 7| 2| 5| | 5| 6| 7| 2| 3| 2| 5| 5| 0| 3| 5| 1| 6| 8| 9| 5| 0| 6| 2| 1| 5| 5| 3| 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| 0| FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 16.6 | 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| MG/KG | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| _____________________________________________________________________________________________________________________| CARDIOVASCULAR SYSTEM - cont | | | | Mineralization | 2 2 | _____________________________________________________________________________________________________________________| ENDOCRINE SYSTEM | | | | __________________________________________________________________________| Adrenal Cortex | + + + + + + + + + + + + + + + + + + + + + + + + +| Accessory Adrenal Cortical Nodule | X | __________________________________________________________________________| Adrenal Medulla | + + + + + + + + + + + + + + + + + + + + + + + + +| Hyperplasia | 2 1 1 2 1 2 | __________________________________________________________________________| Islets, Pancreatic | + + + + + + + + M + + + + + + + + + + + + + + + +| Hyperplasia | | __________________________________________________________________________| Parathyroid Gland | + M + + + + M + + + + + + + + + + + M + + + + + +| Hyperplasia | 2 2 3 3 2 | __________________________________________________________________________| Pituitary Gland | + + + + + + M + + + + + + + M + + + + + + + + + +| Pars Distalis, Angiectasis | 2 2 | Pars Distalis, Cyst | X X | Pars Distalis, Fibrosis | | Pars Distalis, Hyperplasia | 2 2 3 3 1 3 2 | Pars Nervosa, Cyst | | __________________________________________________________________________| Thyroid Gland | + + + + + + M + A + + + + A + + + + + + + + + + +| C-Cell, Hyperplasia | 1 | Follicle, Cyst | | Follicular Cell, Hyperplasia | | _____________________________________________________________________________________________________________________| GENERAL BODY SYSTEM | | | | __________________________________________________________________________| Tissue NOS | | _____________________________________________________________________________________________________________________| GENITAL SYSTEM | | | | __________________________________________________________________________| Epididymis | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Preputial Gland | + + + + + + + + + + + + + M + + + + + + + + + + M| Hyperplasia | 2 | Necrosis | | __________________________________________________________________________| Prostate | + + + + + + + + + + + + + + + + + + + + + + + + +| Hyperplasia | 3 | Inflammation, Chronic Active | | Mineralization | | __________________________________________________________________________| Seminal Vesicle | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Testes | + + + + + + + + + + + + + + + + + + + + + + + + +| Interstitial Cell, Hyperplasia | 2 2 2 3 2 1 | Seminiferous Tubule, Atrophy | 2 | _____________________________________________________________________________________________________________________| HEMATOPOIETIC SYSTEM | | | | __________________________________________________________________________| Blood | + + + + + | __________________________________________________________________________| Bone Marrow | + + + + + + + + A + + + + + + + + + + + + + + + +| __________________________________________________________________________| Lymph Node | + + + + + + + | Mediastinal, Angiectasis | | _____________________________________________________________________________________________________________________| Page 64 NTP Experiment-Test: 05108-01 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:43:56 _____________________________________________________________________________________________________________________ | 7| 6| 5| 5| 4| 7| 6| 5| 5| 4| 7| 7| 6| 5| 4| 7| 7| 6| 4| 4| 7| 7| 6| 6| 5| DAY ON TEST | 2| 1| 9| 8| 6| 2| 6| 7| 2| 6| 2| 0| 6| 9| 7| 2| 0| 6| 6| 0| 2| 2| 7| 2| 5| | 5| 6| 7| 2| 3| 2| 5| 5| 0| 3| 5| 1| 6| 8| 9| 5| 0| 6| 2| 1| 5| 5| 3| 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| 0| FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 16.6 | 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| MG/KG | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| _____________________________________________________________________________________________________________________| HEMATOPOIETIC SYSTEM - cont | | | | __________________________________________________________________________| Lymph Node, Mandibular | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Lymph Node, Mesenteric | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Spleen | + + + + + + + + A + + + + + + + + + + + + + + + +| Fibrosis | 3 1 | Hematopoietic Cell Proliferation | 3 3| Infarct | | __________________________________________________________________________| Thymus | M + + + + + + + + + + + + + + + + + + + + + + + +| Ectopic Parathyroid Gland | | _____________________________________________________________________________________________________________________| INTEGUMENTARY SYSTEM | | | | __________________________________________________________________________| Mammary Gland | + + + + + + + + M + + + + + + + + + + M M + + M M| __________________________________________________________________________| Skin | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| MUSCULOSKELETAL SYSTEM | | | | __________________________________________________________________________| Bone | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| NERVOUS SYSTEM | | | | __________________________________________________________________________| Brain | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Peripheral Nerve | + + | _____________________________________________________________________________________________________________________| RESPIRATORY SYSTEM | | | | __________________________________________________________________________| Lung | + + + + + + + + + + + + + + + + + + + + + + + + +| Edema | 2 | Fibrosis | 1 | Hemorrhage | 3 | Inflammation, Acute | | Mediastinum, Inflammation, Chronic | | Active | | __________________________________________________________________________| Nose | + + + + + + + + + + + + + + + + + + + + + + + + +| Fungus | | Inflammation, Acute | 1 2| __________________________________________________________________________| Trachea | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| SPECIAL SENSES SYSTEM | | | | __________________________________________________________________________| Eye | + | Lens, Cataract | 2 | _____________________________________________________________________________________________________________________| URINARY SYSTEM | | | | __________________________________________________________________________| Kidney | + + + + + + + + + + + + + + + + + + + + + + + + +| Cyst | | Hydronephrosis | 2 | Mineralization | 2 2 | Nephropathy | 4 2 1 2 2 4 4 2 2 3 3 4 2 2 4 4 2 2 1 3 3 2 3 2| __________________________________________________________________________| Urinary Bladder | + + + + + + + + A + + + + + + + + + + + + + + + +| Hyperplasia | | _____________________________________________________________________________________________________________________| Page 65 NTP Experiment-Test: 05108-01 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:43:56 _____________________________________________________________________________________________________________________ | 7| 7| 6| 6| 6| 7| 6| 6| 4| 1| 7| 6| 6| 6| 5| 7| 7| 6| 5| 4| 7| 7| 6| 5| 4| DAY ON TEST | 2| 2| 4| 2| 1| 0| 9| 7| 6| 8| 2| 9| 9| 5| 9| 2| 1| 6| 3| 6| 0| 0| 4| 3| 6| | 5| 5| 2| 6| 6| 4| 7| 3| 3| 4| 5| 4| 1| 6| 9| 5| 5| 5| 6| 2| 2| 0| 7| 2| 2| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 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| 16.6 | 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| MG/KG | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| _____________________________________________________________________________________________________________________| ALIMENTARY SYSTEM | | | | __________________________________________________________________________| Esophagus | + + + + + + + + + + + + + + + + + + + + + + + + +| Hemorrhage | 3 | Hyperkeratosis | 2 | __________________________________________________________________________| Intestine Large, Colon | + + + + + + + + + + + + + + + + A A + + + + + + +| __________________________________________________________________________| Intestine Large, Rectum | + + + + + + + + + + + + + + + + A A + + + + + + +| __________________________________________________________________________| Intestine Large, Cecum | + + + + + + + + + + + + + + + + A A + + + + + + +| Hyperplasia | | __________________________________________________________________________| Intestine Small, Duodenum | + + + + + + + + + + + + + + + + + A + + + + + + +| __________________________________________________________________________| Intestine Small, Jejunum | + + + + + + + + + + + + + + + + A A + + + + + + +| __________________________________________________________________________| Intestine Small, Ileum | + + + + M + + + + + + + + + + + + A + + + + + + +| __________________________________________________________________________| Liver | + + + + + + + + + + + + + + + + + + + + + + + + +| Angiectasis | 2 | Basophilic Focus | 1 X X X X 1 1 X X 1 1 X X X X | Clear Cell Focus | 1 X X | Degeneration, Cystic | 1 2 1 | Eosinophilic Focus | 3 | Fatty Change, Diffuse | 1 1 1 1 1 2 1 1 | Hematopoietic Cell Proliferation | | Hepatodiaphragmatic Nodule | X | Mixed Cell Focus | X X X X X | Necrosis | 2 1 | Bile Duct, Cyst | 1 | Bile Duct, Hyperplasia | 2 2 2 2 2 2 3 2 3 2 | Centrilobular, Hypertrophy | 1| __________________________________________________________________________| Mesentery | + + | Fat, Hemorrhage | | Fat, Mineralization | 2 | Fat, Necrosis | 4 4 | __________________________________________________________________________| Pancreas | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Salivary Glands | + + + + + + + + + + + + + + + + + + + + + + + + +| Duct, Metaplasia, Squamous | 1 | __________________________________________________________________________| Stomach, Forestomach | + + + + + + + + + + + + + + + + + + + + + + + + +| Hyperkeratosis | | Hyperplasia, Basal Cell | | Inflammation, Acute | | Necrosis | 3 | Ulcer | | __________________________________________________________________________| Stomach, Glandular | + + + + + + + + + + + + + + + + + + + + + + + + +| Mineralization | 2 1 2 2 2 | _____________________________________________________________________________________________________________________| CARDIOVASCULAR SYSTEM | | | | __________________________________________________________________________| Heart | + + + + + + + + + + + + + + + + + + + + + + + + +| Cardiomyopathy | 2 2 2 2 2 2 2 3 2 3 2 2 2 2 2 2 2 2 3 2 2 2 2| Inflammation, Acute | 2 | _____________________________________________________________________________________________________________________| Page 66 NTP Experiment-Test: 05108-01 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:43:56 _____________________________________________________________________________________________________________________ | 7| 7| 6| 6| 6| 7| 6| 6| 4| 1| 7| 6| 6| 6| 5| 7| 7| 6| 5| 4| 7| 7| 6| 5| 4| DAY ON TEST | 2| 2| 4| 2| 1| 0| 9| 7| 6| 8| 2| 9| 9| 5| 9| 2| 1| 6| 3| 6| 0| 0| 4| 3| 6| | 5| 5| 2| 6| 6| 4| 7| 3| 3| 4| 5| 4| 1| 6| 9| 5| 5| 5| 6| 2| 2| 0| 7| 2| 2| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 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| 16.6 | 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| MG/KG | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| _____________________________________________________________________________________________________________________| CARDIOVASCULAR SYSTEM - cont | | | | Mineralization | 1 3 1 | _____________________________________________________________________________________________________________________| ENDOCRINE SYSTEM | | | | __________________________________________________________________________| Adrenal Cortex | + + + + + + + + + + + + + + + + + + + + + + + +| Accessory Adrenal Cortical Nodule | | __________________________________________________________________________| Adrenal Medulla | + + + + + + + + + + + + + + + + + + + + + + + + +| Hyperplasia | 3 2 2 1 2 1 | __________________________________________________________________________| Islets, Pancreatic | + + + + + + + + + + + + + + + + + + + + + + + + +| Hyperplasia | 2 2 | __________________________________________________________________________| Parathyroid Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| Hyperplasia | 2 2 | __________________________________________________________________________| Pituitary Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| Pars Distalis, Angiectasis | 2 2 | Pars Distalis, Cyst | X X | Pars Distalis, Fibrosis | | Pars Distalis, Hyperplasia | 2 3 3 3 2 | Pars Nervosa, Cyst | | __________________________________________________________________________| Thyroid Gland | + + + + + + + + + + + + + + + + A A + + + + + + +| C-Cell, Hyperplasia | | Follicle, Cyst | | Follicular Cell, Hyperplasia | 2 | _____________________________________________________________________________________________________________________| GENERAL BODY SYSTEM | | | | __________________________________________________________________________| Tissue NOS | + | _____________________________________________________________________________________________________________________| GENITAL SYSTEM | | | | __________________________________________________________________________| Epididymis | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Preputial Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| Hyperplasia | | Necrosis | 3 3 | __________________________________________________________________________| Prostate | + + + + + + + + + + + + + + + + + + + + + + + + +| Hyperplasia | 2 1 | Inflammation, Chronic Active | 3 | Mineralization | 2 | __________________________________________________________________________| Seminal Vesicle | + + + + + + + + + + + + M + + + + + + + + + + + +| __________________________________________________________________________| Testes | + + + + + + + + + + + + + + + + + + + + + + + + +| Interstitial Cell, Hyperplasia | 2 2 2 2 2| Seminiferous Tubule, Atrophy | 4 3 | _____________________________________________________________________________________________________________________| HEMATOPOIETIC SYSTEM | | | | __________________________________________________________________________| Blood | + + + + + | __________________________________________________________________________| Bone Marrow | + + + + + + + + + + + + + + A + + + + + + + + + +| __________________________________________________________________________| Lymph Node | + + + + | Mediastinal, Angiectasis | | _____________________________________________________________________________________________________________________| Page 67 NTP Experiment-Test: 05108-01 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:43:56 _____________________________________________________________________________________________________________________ | 7| 7| 6| 6| 6| 7| 6| 6| 4| 1| 7| 6| 6| 6| 5| 7| 7| 6| 5| 4| 7| 7| 6| 5| 4| DAY ON TEST | 2| 2| 4| 2| 1| 0| 9| 7| 6| 8| 2| 9| 9| 5| 9| 2| 1| 6| 3| 6| 0| 0| 4| 3| 6| | 5| 5| 2| 6| 6| 4| 7| 3| 3| 4| 5| 4| 1| 6| 9| 5| 5| 5| 6| 2| 2| 0| 7| 2| 2| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 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| 16.6 | 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| MG/KG | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| _____________________________________________________________________________________________________________________| HEMATOPOIETIC SYSTEM - cont | | | | __________________________________________________________________________| Lymph Node, Mandibular | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Lymph Node, Mesenteric | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Spleen | + + + + + + + + + + + + + + + + + + + + + + + + +| Fibrosis | 1 | Hematopoietic Cell Proliferation | | Infarct | 2 2 | __________________________________________________________________________| Thymus | + + + + + M + + + + + + M + + + + + + + + + + + +| Ectopic Parathyroid Gland | X | _____________________________________________________________________________________________________________________| INTEGUMENTARY SYSTEM | | | | __________________________________________________________________________| Mammary Gland | + + M + + + + M + + + + + M + + + + + + M + M + +| __________________________________________________________________________| Skin | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| MUSCULOSKELETAL SYSTEM | | | | __________________________________________________________________________| Bone | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| NERVOUS SYSTEM | | | | __________________________________________________________________________| Brain | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Peripheral Nerve | | _____________________________________________________________________________________________________________________| RESPIRATORY SYSTEM | | | | __________________________________________________________________________| Lung | + + + + + + + + + + + + + + + + + + + + + + + +| Edema | 2 | Fibrosis | | Hemorrhage | 2 2 | Inflammation, Acute | 1 | Mediastinum, Inflammation, Chronic | | Active | 3 | __________________________________________________________________________| Nose | + + + + + + + + + + + + + + + + + + + + + + + + +| Fungus | 2| Inflammation, Acute | 1 1 3 3| __________________________________________________________________________| Trachea | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| SPECIAL SENSES SYSTEM | | | | __________________________________________________________________________| Eye | + | Lens, Cataract | 3 | _____________________________________________________________________________________________________________________| URINARY SYSTEM | | | | __________________________________________________________________________| Kidney | + + + + + + + + + + + + + + + + + + + + + + + + +| Cyst | X X | Hydronephrosis | 2 | Mineralization | 2 3 2 | Nephropathy | 2 4 4 3 3 4 3 3 3 3 3 3 3 3 3 3 4 2 2 4 4 3 2 2| __________________________________________________________________________| Urinary Bladder | + + + + + + + + + + + + + + + + + + + + + + + + +| Hyperplasia | 1 | _____________________________________________________________________________________________________________________| Page 68 NTP Experiment-Test: 05108-01 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:43:56 __________________________________________________________________________________________________________________________________ | 7| 5| 5| 4| 4| 6| 5| 5| 4| 4| | | DAY ON TEST | 1| 7| 5| 6| 6| 3| 7| 2| 6| 6| | | | 8| 1| 5| 3| 3| 9| 0| 2| 2| 2| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| | A | 16.6 | 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| | L | MG/KG | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| | | __________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM | | | | | | __________________________________________________________________________|____________| Esophagus | + + + + + + + + + + | 59 | Hemorrhage | | 1 3.0| Hyperkeratosis | | 1 2.0| __________________________________________________________________________|____________| Intestine Large, Colon | + + A + + + + + + + | 54 | __________________________________________________________________________|____________| Intestine Large, Rectum | A + A + + + + + M + | 50 | __________________________________________________________________________|____________| Intestine Large, Cecum | + + A + + + + + + + | 52 | Hyperplasia | | 1 2.0| __________________________________________________________________________|____________| Intestine Small, Duodenum | + + + + + + + + + + | 56 | __________________________________________________________________________|____________| Intestine Small, Jejunum | A + A + + A + + + + | 50 | __________________________________________________________________________|____________| Intestine Small, Ileum | + + + + + + + + + + | 53 | __________________________________________________________________________|____________| Liver | + + + + + + + + + + | 60 | Angiectasis | | 2 2.0| Basophilic Focus | X X 1 | 25 1.2| Clear Cell Focus | | 8 1.3| Degeneration, Cystic | 1 | 7 1.6| Eosinophilic Focus | | 5 2.8| Fatty Change, Diffuse | 1 2 2 1 2 2 | 25 1.4| Hematopoietic Cell Proliferation | | 1 2.0| Hepatodiaphragmatic Nodule | | 1 | Mixed Cell Focus | | 8 | Necrosis | | 5 1.8| Bile Duct, Cyst | | 1 1.0| Bile Duct, Hyperplasia | 2 2 1 2 | 22 1.9| Centrilobular, Hypertrophy | | 1 1.0| __________________________________________________________________________|____________| Mesentery | + | 3 | Fat, Hemorrhage | 4 | 1 4.0| Fat, Mineralization | | 1 2.0| Fat, Necrosis | | 2 4.0| __________________________________________________________________________|____________| Pancreas | + + + + + + + + + + | 59 | __________________________________________________________________________|____________| Salivary Glands | + + + + + + + + + + | 60 | Duct, Metaplasia, Squamous | | 1 1.0| __________________________________________________________________________|____________| Stomach, Forestomach | + + + + + + + + + + | 60 | Hyperkeratosis | | 1 2.0| Hyperplasia, Basal Cell | | 2 1.5| Inflammation, Acute | 2 | 1 2.0| Necrosis | | 2 3.0| Ulcer | | 1 3.0| __________________________________________________________________________|____________| Stomach, Glandular | + + + + + + + + + + | 57 | Mineralization | 1 | 8 1.8| __________________________________________________________________________________________________________________________________ * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 69 NTP Experiment-Test: 05108-01 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:43:56 __________________________________________________________________________________________________________________________________ | 7| 5| 5| 4| 4| 6| 5| 5| 4| 4| | | DAY ON TEST | 1| 7| 5| 6| 6| 3| 7| 2| 6| 6| | | | 8| 1| 5| 3| 3| 9| 0| 2| 2| 2| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| | A | 16.6 | 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| | L | MG/KG | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| | | __________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - cont | | | | | | _____________________________________________________________________________________________________________________| | CARDIOVASCULAR SYSTEM | | | | | | __________________________________________________________________________|____________| Heart | + + + + + + + + + + | 60 | Cardiomyopathy | 2 2 2 2 2 2 | 46 2.1| Inflammation, Acute | | 1 2.0| Mineralization | | 5 1.8| _____________________________________________________________________________________________________________________| | ENDOCRINE SYSTEM | | | | | | __________________________________________________________________________|____________| Adrenal Cortex | + + + + + + + + + + | 59 | Accessory Adrenal Cortical Nodule | | 1 | __________________________________________________________________________|____________| Adrenal Medulla | + + M + + + + + + + | 59 | Hyperplasia | 2 2 | 14 1.7| __________________________________________________________________________|____________| Islets, Pancreatic | + + + + + + + + + + | 59 | Hyperplasia | | 2 2.0| __________________________________________________________________________|____________| Parathyroid Gland | + + + + + + + + + + | 57 | Hyperplasia | 2 | 8 2.3| __________________________________________________________________________|____________| Pituitary Gland | + + + + + + + + + + | 58 | Pars Distalis, Angiectasis | 3 2 | 6 2.2| Pars Distalis, Cyst | | 4 | Pars Distalis, Fibrosis | 2 | 1 2.0| Pars Distalis, Hyperplasia | 2 1 3 2 | 16 2.3| Pars Nervosa, Cyst | X | 1 | __________________________________________________________________________|____________| Thyroid Gland | + + A + + + + + + + | 54 | C-Cell, Hyperplasia | | 1 1.0| Follicle, Cyst | X | 1 | Follicular Cell, Hyperplasia | | 1 2.0| _____________________________________________________________________________________________________________________| | GENERAL BODY SYSTEM | | | | | | __________________________________________________________________________|____________| Tissue NOS | | 1 | _____________________________________________________________________________________________________________________| | GENITAL SYSTEM | | | | | | __________________________________________________________________________|____________| Epididymis | + + + + + + + + + + | 60 | __________________________________________________________________________|____________| Preputial Gland | + + + + + + + + + + | 58 | Hyperplasia | | 1 2.0| Necrosis | | 2 3.0| __________________________________________________________________________|____________| Prostate | + + + + + + + + + + | 60 | Hyperplasia | | 3 2.0| Inflammation, Chronic Active | | 1 3.0| Mineralization | | 1 2.0| __________________________________________________________________________________________________________________________________ * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 70 NTP Experiment-Test: 05108-01 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:43:56 __________________________________________________________________________________________________________________________________ | 7| 5| 5| 4| 4| 6| 5| 5| 4| 4| | | DAY ON TEST | 1| 7| 5| 6| 6| 3| 7| 2| 6| 6| | | | 8| 1| 5| 3| 3| 9| 0| 2| 2| 2| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| | A | 16.6 | 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| | L | MG/KG | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| | | __________________________________________________________________________________________________________________________________ GENITAL SYSTEM - cont | | | | | | __________________________________________________________________________|____________| Seminal Vesicle | + + + + + + + + + + | 59 | __________________________________________________________________________|____________| Testes | + + + + + + + + + + | 60 | Interstitial Cell, Hyperplasia | 2 2 2 2 1 2 2 2 | 19 1.9| Seminiferous Tubule, Atrophy | | 3 3.0| _____________________________________________________________________________________________________________________| | HEMATOPOIETIC SYSTEM | | | | | | __________________________________________________________________________|____________| Blood | + + + | 13 | __________________________________________________________________________|____________| Bone Marrow | + + + + + + + + + + | 58 | __________________________________________________________________________|____________| Lymph Node | + + + + | 15 | Mediastinal, Angiectasis | 2 | 1 2.0| __________________________________________________________________________|____________| Lymph Node, Mandibular | + + + M + + + + + + | 59 | __________________________________________________________________________|____________| Lymph Node, Mesenteric | + + + + + + + + + + | 60 | __________________________________________________________________________|____________| Spleen | + + + + + + + + + + | 59 | Fibrosis | 2 | 4 1.8| Hematopoietic Cell Proliferation | | 2 3.0| Infarct | | 2 2.0| __________________________________________________________________________|____________| Thymus | + + + + + + + M + + | 56 | Ectopic Parathyroid Gland | | 1 | _____________________________________________________________________________________________________________________| | INTEGUMENTARY SYSTEM | | | | | | __________________________________________________________________________|____________| Mammary Gland | M + + + + M + + + M | 47 | __________________________________________________________________________|____________| Skin | + + + + + + + + + + | 60 | _____________________________________________________________________________________________________________________| | MUSCULOSKELETAL SYSTEM | | | | | | __________________________________________________________________________|____________| Bone | + + + + + + + + + + | 60 | _____________________________________________________________________________________________________________________| | NERVOUS SYSTEM | | | | | | __________________________________________________________________________|____________| Brain | + + + + + + + + + + | 60 | __________________________________________________________________________|____________| Peripheral Nerve | | 2 | _____________________________________________________________________________________________________________________| | RESPIRATORY SYSTEM | | | | | | __________________________________________________________________________|____________| Lung | + + + + + + + + + + | 59 | Edema | 2 | 3 2.0| Fibrosis | | 1 1.0| Hemorrhage | | 3 2.3| Inflammation, Acute | 3 | 2 2.0| Mediastinum, Inflammation, Chronic | | | Active | | 1 3.0| __________________________________________________________________________|____________| Nose | + + + + + + + + + + | 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 71 NTP Experiment-Test: 05108-01 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:43:56 __________________________________________________________________________________________________________________________________ | 7| 5| 5| 4| 4| 6| 5| 5| 4| 4| | | DAY ON TEST | 1| 7| 5| 6| 6| 3| 7| 2| 6| 6| | | | 8| 1| 5| 3| 3| 9| 0| 2| 2| 2| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| | A | 16.6 | 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| | L | MG/KG | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| | | __________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM - cont | | | | | | Fungus | | 1 2.0| Inflammation, Acute | 1 3 | 8 1.9| __________________________________________________________________________|____________| Trachea | + + + + + + + + + + | 60 | _____________________________________________________________________________________________________________________| | SPECIAL SENSES SYSTEM | | | | | | __________________________________________________________________________|____________| Eye | | 2 | Lens, Cataract | | 2 2.5| _____________________________________________________________________________________________________________________| | URINARY SYSTEM | | | | | | __________________________________________________________________________|____________| Kidney | + + + + + + + + + + | 60 | Cyst | | 2 | Hydronephrosis | | 2 2.0| Mineralization | | 5 2.2| Nephropathy | 4 2 2 2 1 4 2 2 2 2 | 58 2.7| __________________________________________________________________________|____________| Urinary Bladder | + + + + + + + + + + | 59 | Hyperplasia | | 1 1.0| __________________________________________________________________________________________________________________________________ * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 72 NTP Experiment-Test: 05108-01 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:43:56 _____________________________________________________________________________________________________________________ | 7| 6| 6| 6| 5| 6| 5| 5| 4| 1| 6| 6| 4| 4| 0| 6| 5| 5| 4| 3| 2| 7| 7| 6| 4| DAY ON TEST | 1| 5| 5| 0| 6| 2| 9| 6| 6| 3| 7| 2| 6| 6| 4| 6| 8| 6| 6| 6| 8| 1| 1| 1| 6| | 7| 8| 6| 4| 8| 5| 2| 2| 3| 8| 5| 4| 3| 2| 9| 7| 4| 5| 2| 5| 8| 7| 7| 7| 2| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 33.3 | 7| 7| 7| 7| 7| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| MG/KG | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| _____________________________________________________________________________________________________________________| ALIMENTARY SYSTEM | | | | __________________________________________________________________________| Esophagus | + + + + + + + + + + + + + + + + + + + + + + + + +| Hyperkeratosis | | Inflammation, Acute | | Necrosis | | __________________________________________________________________________| Intestine Large, Colon | + + + A A + + + + A + + + + + + + A + + + + + + +| __________________________________________________________________________| Intestine Large, Rectum | + + + + A + A + + A + + + + + + + A + + + + + + +| __________________________________________________________________________| Intestine Large, Cecum | + + + A A + A + + A M + + + + + + A + + + + + + +| __________________________________________________________________________| Intestine Small, Duodenum | + + + A A + + + + A + + + + + + + + + + + + + + +| __________________________________________________________________________| Intestine Small, Jejunum | + + + A A + A + + A + + + + + A + A + + + + + + +| __________________________________________________________________________| Intestine Small, Ileum | + + + A A + A + + A + + + + + A + A + + + + + + +| __________________________________________________________________________| Liver | + + + + + + + + + + + + + + + + + + + + + + + + +| Basophilic Focus | X X X X X X 1 X X X X 2 | Clear Cell Focus | X X X 1 X X | Degeneration, Cystic | 2 2 2 | Eosinophilic Focus | 3 2 | Fatty Change, Diffuse | 1 2 1 1 1 1 2 2 2 2 2 1 2 2 1 1 3 2| Fatty Change, Focal | | Hepatodiaphragmatic Nodule | | Hyperplasia | 2 | Mixed Cell Focus | X X X X X | Necrosis, Focal | 2 | Necrosis | 2 | Thrombosis | | Bile Duct, Hyperplasia | 3 2 2 2 | Centrilobular, Hypertrophy | 1 1 1 1| __________________________________________________________________________| Mesentery | + + + | Fat, Fibrosis | 2 | Fat, Inflammation, Chronic Active | 2 | Fat, Necrosis | 2 | __________________________________________________________________________| Pancreas | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Pharynx | + | Inflammation, Acute | 3 | Palate, Inflammation, Acute | | __________________________________________________________________________| Salivary Glands | + + + M + + + + + + + + + + + + + + + + + + + + +| Duct, Metaplasia, Squamous | 1 | __________________________________________________________________________| Stomach, Forestomach | + + + + + + + + + + + + + + + + + + + + + + + + +| Cyst Epithelial Inclusion | | Hyperkeratosis | 2 | Hyperplasia, Basal Cell | 2 | Hyperplasia, Squamous | | Necrosis | 2 | Ulcer | 2 | __________________________________________________________________________| Stomach, Glandular | + + + A A + + + + A + + + + + + + A + + + + + + +| Necrosis | 2 2 | _____________________________________________________________________________________________________________________| Page 73 NTP Experiment-Test: 05108-01 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:43:56 _____________________________________________________________________________________________________________________ | 7| 6| 6| 6| 5| 6| 5| 5| 4| 1| 6| 6| 4| 4| 0| 6| 5| 5| 4| 3| 2| 7| 7| 6| 4| DAY ON TEST | 1| 5| 5| 0| 6| 2| 9| 6| 6| 3| 7| 2| 6| 6| 4| 6| 8| 6| 6| 6| 8| 1| 1| 1| 6| | 7| 8| 6| 4| 8| 5| 2| 2| 3| 8| 5| 4| 3| 2| 9| 7| 4| 5| 2| 5| 8| 7| 7| 7| 2| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 33.3 | 7| 7| 7| 7| 7| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| MG/KG | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| _____________________________________________________________________________________________________________________| ALIMENTARY SYSTEM - cont | | | | __________________________________________________________________________| Tongue | + | Hyperkeratosis | 1 | _____________________________________________________________________________________________________________________| CARDIOVASCULAR SYSTEM | | | | __________________________________________________________________________| Heart | + + + + + + + + + + + + + + + + + + + + + + + + +| Cardiomyopathy | 2 2 3 2 3 2 2 2 2 2 2 1 2 2 2 2 2 2 2 2 | Congestion | | Mineralization | | _____________________________________________________________________________________________________________________| ENDOCRINE SYSTEM | | | | __________________________________________________________________________| Adrenal Cortex | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Adrenal Medulla | + + + + + + + + + + + + + + M + + + + + + + + + +| Hyperplasia | 1 1 1 2 2 | __________________________________________________________________________| Islets, Pancreatic | + + + + + + + + + A + + + + + + + + + + + + + + +| Hyperplasia | 2 3 | __________________________________________________________________________| Parathyroid Gland | + + + M + + + + + + + + + + + + + + + + + + + + +| Hyperplasia | 2 2 2 | __________________________________________________________________________| Pituitary Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| Pars Distalis, Angiectasis | 2 | Pars Distalis, Hyperplasia | 2 3 1 3 | Pars Distalis, Infarct | | __________________________________________________________________________| Thyroid Gland | + + + M A + A + + A + + + + + + + A + + + + + + +| C-Cell, Hyperplasia | 1 | Follicle, Cyst | X | Follicular Cell, Hyperplasia | | _____________________________________________________________________________________________________________________| GENERAL BODY SYSTEM | | | | None | | _____________________________________________________________________________________________________________________| GENITAL SYSTEM | | | | __________________________________________________________________________| Epididymis | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Preputial Gland | + + + + + + + + + + + M + + + + + + + + + + + + +| Hyperplasia | | __________________________________________________________________________| Prostate | + + + + + + + + + + + + + + + + + + + + + + + + +| Inflammation, Chronic Active | 2 | __________________________________________________________________________| Seminal Vesicle | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Testes | + + + + + + + + + + + + + + + + + + + + + + + + +| Interstitial Cell, Hyperplasia | 2 2 2 2 2 2 1 1 2| Seminiferous Tubule, Atrophy | 3 2 3 | _____________________________________________________________________________________________________________________| HEMATOPOIETIC SYSTEM | | | | __________________________________________________________________________| Blood | + | __________________________________________________________________________| Bone Marrow | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Lymph Node | + + | _____________________________________________________________________________________________________________________| Page 74 NTP Experiment-Test: 05108-01 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:43:56 _____________________________________________________________________________________________________________________ | 7| 6| 6| 6| 5| 6| 5| 5| 4| 1| 6| 6| 4| 4| 0| 6| 5| 5| 4| 3| 2| 7| 7| 6| 4| DAY ON TEST | 1| 5| 5| 0| 6| 2| 9| 6| 6| 3| 7| 2| 6| 6| 4| 6| 8| 6| 6| 6| 8| 1| 1| 1| 6| | 7| 8| 6| 4| 8| 5| 2| 2| 3| 8| 5| 4| 3| 2| 9| 7| 4| 5| 2| 5| 8| 7| 7| 7| 2| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 33.3 | 7| 7| 7| 7| 7| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| MG/KG | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| _____________________________________________________________________________________________________________________| HEMATOPOIETIC SYSTEM - cont | | | | __________________________________________________________________________| Lymph Node, Mandibular | + + + M + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Lymph Node, Mesenteric | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Spleen | + + + + + + + + + + + + + + + + + + + + + + + + +| Cyst | | Fibrosis | 2 1 | __________________________________________________________________________| Thymus | + + + M + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| INTEGUMENTARY SYSTEM | | | | __________________________________________________________________________| Mammary Gland | + + + + + + + + M M + + + + M M + + + M + + + + +| Galactocele | X X | Acinus, Hyperplasia | 2 | __________________________________________________________________________| Skin | + + + + + + + + + + + + + + + + + + + + + + + + +| Acanthosis | | Hyperkeratosis | | _____________________________________________________________________________________________________________________| MUSCULOSKELETAL SYSTEM | | | | __________________________________________________________________________| Bone | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Skeletal Muscle | | Edema | | Hemorrhage | | _____________________________________________________________________________________________________________________| NERVOUS SYSTEM | | | | __________________________________________________________________________| Brain | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| RESPIRATORY SYSTEM | | | | __________________________________________________________________________| Lung | + + + + + + + + + + + + + + + + + + + + + + + + +| Edema | 3 2 | Hemorrhage | | Infiltration Cellular, Histiocyte | | Inflammation, Acute | 3 3 | Mediastinum, Inflammation, Chronic | | Active | | __________________________________________________________________________| Nose | + + + + + + + + + + + + + + + + + + + + + + + + +| Fungus | 2 2 2 2 | Inflammation, Acute | 3 3 3 1 3 | __________________________________________________________________________| Trachea | + + + + + + + + + + + + + + + + + + + + + + + + +| Erosion | | Inflammation, Acute | | _____________________________________________________________________________________________________________________| SPECIAL SENSES SYSTEM | | | | __________________________________________________________________________| Eye | + | __________________________________________________________________________| Zymbal's Gland | | _____________________________________________________________________________________________________________________| URINARY SYSTEM | | | | _____________________________________________________________________________________________________________________| Page 75 NTP Experiment-Test: 05108-01 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:43:56 _____________________________________________________________________________________________________________________ | 7| 6| 6| 6| 5| 6| 5| 5| 4| 1| 6| 6| 4| 4| 0| 6| 5| 5| 4| 3| 2| 7| 7| 6| 4| DAY ON TEST | 1| 5| 5| 0| 6| 2| 9| 6| 6| 3| 7| 2| 6| 6| 4| 6| 8| 6| 6| 6| 8| 1| 1| 1| 6| | 7| 8| 6| 4| 8| 5| 2| 2| 3| 8| 5| 4| 3| 2| 9| 7| 4| 5| 2| 5| 8| 7| 7| 7| 2| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 33.3 | 7| 7| 7| 7| 7| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| MG/KG | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| _____________________________________________________________________________________________________________________| URINARY SYSTEM - cont | | | | __________________________________________________________________________| Kidney | + + + + + + + + + + + + + + + + + + + + + + + + +| Cyst | X X | Hemorrhage | | Mineralization | | Nephropathy | 3 2 4 3 2 2 2 4 2 3 4 3 3 4 4 2 2 2 3 3 3 2| Renal Tubule, Hyperplasia | 2 | __________________________________________________________________________| Urinary Bladder | + + + + A + + + + A + + + + + + + + + + + + + + +| Calculus Gross Observation | X | Calculus Micro Observation Only | X | Dilatation | | _____________________________________________________________________________________________________________________| Page 76 NTP Experiment-Test: 05108-01 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:43:56 _____________________________________________________________________________________________________________________ | 7| 7| 6| 5| 4| 6| 6| 6| 5| 4| 7| 6| 6| 6| 5| 7| 6| 6| 5| 4| 7| 7| 6| 6| 4| DAY ON TEST | 1| 1| 1| 7| 6| 5| 2| 0| 9| 6| 1| 8| 6| 3| 5| 1| 9| 5| 4| 5| 1| 1| 6| 0| 6| | 7| 5| 2| 6| 2| 8| 4| 2| 2| 2| 7| 0| 6| 2| 5| 7| 3| 7| 1| 8| 7| 7| 7| 8| 2| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 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| 33.3 | 2| 2| 2| 2| 2| 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| MG/KG | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| _____________________________________________________________________________________________________________________| ALIMENTARY SYSTEM | | | | __________________________________________________________________________| Esophagus | + + + + + M + + + + + + + + + + + + + + + + + + +| Hyperkeratosis | 2 1 2 | Inflammation, Acute | 3 | Necrosis | 4 | __________________________________________________________________________| Intestine Large, Colon | + + + + + + + + A + + + + + A + + + A A + + + A +| __________________________________________________________________________| Intestine Large, Rectum | + + + A + + + + A + + + + + A + + + A A + + + A +| __________________________________________________________________________| Intestine Large, Cecum | + + + A + + + + A + + + + + A + + + A A + + + A +| __________________________________________________________________________| Intestine Small, Duodenum | + + + + + + + + + + + + + + A + + + A A + + + + +| __________________________________________________________________________| Intestine Small, Jejunum | + + + A + + + + A + + + + + A + + + A A + + + A +| __________________________________________________________________________| Intestine Small, Ileum | + + + A + + + + A + + + + + A + + + A A + + + A +| __________________________________________________________________________| Liver | + + + + + + + + + + + + + + + + + + + + + + + + +| Basophilic Focus | 1 X X X X 1 1 | Clear Cell Focus | X 1 X | Degeneration, Cystic | 2 | Eosinophilic Focus | 4 1 | Fatty Change, Diffuse | 2 1 3 1 3 1 2 1 1 2 2 2 1 3| Fatty Change, Focal | 1 | Hepatodiaphragmatic Nodule | | Hyperplasia | | Mixed Cell Focus | X 1 X X X X | Necrosis, Focal | | Necrosis | | Thrombosis | 2 | Bile Duct, Hyperplasia | 3 1 3 2 2 2 1 3 | Centrilobular, Hypertrophy | 1 1 1| __________________________________________________________________________| Mesentery | | Fat, Fibrosis | | Fat, Inflammation, Chronic Active | | Fat, Necrosis | | __________________________________________________________________________| Pancreas | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Pharynx | + | Inflammation, Acute | | Palate, Inflammation, Acute | 3 | __________________________________________________________________________| Salivary Glands | + + + + + + + + + + + + + + + + + + + + + + + + +| Duct, Metaplasia, Squamous | 1 | __________________________________________________________________________| Stomach, Forestomach | + + + + + + + + + + + + + + + + + + + + + + + + +| Cyst Epithelial Inclusion | X | Hyperkeratosis | 2 3 3 | Hyperplasia, Basal Cell | 2 2 2 2 | Hyperplasia, Squamous | 4 | Necrosis | | Ulcer | 2 3 2 | __________________________________________________________________________| Stomach, Glandular | + + + + + + + + + + + + + + + + + + A + + + + + +| Necrosis | | _____________________________________________________________________________________________________________________| Page 77 NTP Experiment-Test: 05108-01 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:43:56 _____________________________________________________________________________________________________________________ | 7| 7| 6| 5| 4| 6| 6| 6| 5| 4| 7| 6| 6| 6| 5| 7| 6| 6| 5| 4| 7| 7| 6| 6| 4| DAY ON TEST | 1| 1| 1| 7| 6| 5| 2| 0| 9| 6| 1| 8| 6| 3| 5| 1| 9| 5| 4| 5| 1| 1| 6| 0| 6| | 7| 5| 2| 6| 2| 8| 4| 2| 2| 2| 7| 0| 6| 2| 5| 7| 3| 7| 1| 8| 7| 7| 7| 8| 2| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 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| 33.3 | 2| 2| 2| 2| 2| 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| MG/KG | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| _____________________________________________________________________________________________________________________| ALIMENTARY SYSTEM - cont | | | | __________________________________________________________________________| Tongue | | Hyperkeratosis | | _____________________________________________________________________________________________________________________| CARDIOVASCULAR SYSTEM | | | | __________________________________________________________________________| Heart | + + + + + + + + + + + + + + + + + + + + + + + + +| Cardiomyopathy | 3 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 3 2 2 2 2| Congestion | 3 | Mineralization | 1 | _____________________________________________________________________________________________________________________| ENDOCRINE SYSTEM | | | | __________________________________________________________________________| Adrenal Cortex | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Adrenal Medulla | + + + + + + + + + + + + + + + + + + + + + + + + +| Hyperplasia | 1 1 2 | __________________________________________________________________________| Islets, Pancreatic | + + + + + + + M + + + + + + + + + + + + + + + + +| Hyperplasia | 1 | __________________________________________________________________________| Parathyroid Gland | + + M + + M + + + + + + M + + + + + + + + + + + +| Hyperplasia | | __________________________________________________________________________| Pituitary Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| Pars Distalis, Angiectasis | 2 2 | Pars Distalis, Hyperplasia | 2 2 2 | Pars Distalis, Infarct | 3 | __________________________________________________________________________| Thyroid Gland | + + + A + + + + + + + + + + A + + A A A + + + + +| C-Cell, Hyperplasia | | Follicle, Cyst | | Follicular Cell, Hyperplasia | | _____________________________________________________________________________________________________________________| GENERAL BODY SYSTEM | | | | None | | _____________________________________________________________________________________________________________________| GENITAL SYSTEM | | | | __________________________________________________________________________| Epididymis | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Preputial Gland | + + + + + + + + + + + + + + + + + + + + + + + + +| Hyperplasia | | __________________________________________________________________________| Prostate | + + + + + + + + + + + + + + + + + + + + + + + M +| Inflammation, Chronic Active | 2 | __________________________________________________________________________| Seminal Vesicle | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Testes | + + + + + + + + + + + + + + + + + + + + + + + + +| Interstitial Cell, Hyperplasia | 2 2 1 2| Seminiferous Tubule, Atrophy | 3 3 3 2 3 | _____________________________________________________________________________________________________________________| HEMATOPOIETIC SYSTEM | | | | __________________________________________________________________________| Blood | + + + + + + | __________________________________________________________________________| Bone Marrow | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Lymph Node | + + | _____________________________________________________________________________________________________________________| Page 78 NTP Experiment-Test: 05108-01 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:43:56 _____________________________________________________________________________________________________________________ | 7| 7| 6| 5| 4| 6| 6| 6| 5| 4| 7| 6| 6| 6| 5| 7| 6| 6| 5| 4| 7| 7| 6| 6| 4| DAY ON TEST | 1| 1| 1| 7| 6| 5| 2| 0| 9| 6| 1| 8| 6| 3| 5| 1| 9| 5| 4| 5| 1| 1| 6| 0| 6| | 7| 5| 2| 6| 2| 8| 4| 2| 2| 2| 7| 0| 6| 2| 5| 7| 3| 7| 1| 8| 7| 7| 7| 8| 2| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 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| 33.3 | 2| 2| 2| 2| 2| 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| MG/KG | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| _____________________________________________________________________________________________________________________| HEMATOPOIETIC SYSTEM - cont | | | | __________________________________________________________________________| Lymph Node, Mandibular | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Lymph Node, Mesenteric | + + + + + + + + + + + + + + + + + + + + + + + A +| __________________________________________________________________________| Spleen | + + + + + + + + + + + + + + + + + + + + + + + + +| Cyst | X | Fibrosis | 2 2 | __________________________________________________________________________| Thymus | + + + + + + + + + + M M + + + + + + + + + + + A +| _____________________________________________________________________________________________________________________| INTEGUMENTARY SYSTEM | | | | __________________________________________________________________________| Mammary Gland | + + + + M + + + + M + + + + + M + M + + + + M + M| Galactocele | | Acinus, Hyperplasia | | __________________________________________________________________________| Skin | + + + + + + + + + + + + + + + + + + + + + + + + +| Acanthosis | 2 | Hyperkeratosis | 4 | _____________________________________________________________________________________________________________________| MUSCULOSKELETAL SYSTEM | | | | __________________________________________________________________________| Bone | + + + + + + + + + + + + + + + + + + + + + + + + +| __________________________________________________________________________| Skeletal Muscle | + | Edema | 2 | Hemorrhage | 3 | _____________________________________________________________________________________________________________________| NERVOUS SYSTEM | | | | __________________________________________________________________________| Brain | + + + + + + + + + + + + + + + + + + + + + + + + +| _____________________________________________________________________________________________________________________| RESPIRATORY SYSTEM | | | | __________________________________________________________________________| Lung | + + + + + + + + + + + + + + + + + + + + + + + + +| Edema | 3 2 | Hemorrhage | | Infiltration Cellular, Histiocyte | 2 | Inflammation, Acute | 2 3 | Mediastinum, Inflammation, Chronic | | Active | 2 | __________________________________________________________________________| Nose | + + + + + + + + + + + + + + + + + + + + + + + + +| Fungus | 2 | Inflammation, Acute | 3 1 2 | __________________________________________________________________________| Trachea | + + + + + + + + + + + + + + + + + + + + + + + + +| Erosion | 4 | Inflammation, Acute | 2 | _____________________________________________________________________________________________________________________| SPECIAL SENSES SYSTEM | | | | __________________________________________________________________________| Eye | I | __________________________________________________________________________| Zymbal's Gland | + | _____________________________________________________________________________________________________________________| URINARY SYSTEM | | | | _____________________________________________________________________________________________________________________| Page 79 NTP Experiment-Test: 05108-01 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:43:56 _____________________________________________________________________________________________________________________ | 7| 7| 6| 5| 4| 6| 6| 6| 5| 4| 7| 6| 6| 6| 5| 7| 6| 6| 5| 4| 7| 7| 6| 6| 4| DAY ON TEST | 1| 1| 1| 7| 6| 5| 2| 0| 9| 6| 1| 8| 6| 3| 5| 1| 9| 5| 4| 5| 1| 1| 6| 0| 6| | 7| 5| 2| 6| 2| 8| 4| 2| 2| 2| 7| 0| 6| 2| 5| 7| 3| 7| 1| 8| 7| 7| 7| 8| 2| _____________________________________________________________________________________________________________________| | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| ANIMAL ID | 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| 33.3 | 2| 2| 2| 2| 2| 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| MG/KG | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| _____________________________________________________________________________________________________________________| URINARY SYSTEM - cont | | | | __________________________________________________________________________| Kidney | + + + + + + + + + + + + + + + + + + + + + + + + +| Cyst | X | Hemorrhage | 4 | Mineralization | | Nephropathy | 3 4 2 2 1 3 3 2 3 2 3 3 3 4 2 2 3 3 1 1 3 4 4 2 1| Renal Tubule, Hyperplasia | | __________________________________________________________________________| Urinary Bladder | + + + A + + + + + + + + + + + + + + + + + + + + +| Calculus Gross Observation | | Calculus Micro Observation Only | | Dilatation | | _____________________________________________________________________________________________________________________| Page 80 NTP Experiment-Test: 05108-01 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:43:56 __________________________________________________________________________________________________________________________________ | 7| 7| 6| 4| 2| 6| 7| 6| 5| 0| | | DAY ON TEST | 1| 0| 3| 6| 8| 2| 1| 2| 8| 5| | | | 7| 8| 9| 3| 9| 0| 7| 4| 3| 3| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| | A | 33.3 | 7| 7| 7| 7| 7| 8| 8| 8| 8| 8| | L | MG/KG | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| | | __________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM | | | | | | __________________________________________________________________________|____________| Esophagus | + + + + + + + + + + | 59 | Hyperkeratosis | | 3 1.7| Inflammation, Acute | | 1 3.0| Necrosis | | 1 4.0| __________________________________________________________________________|____________| Intestine Large, Colon | + + + + A A + + + + | 49 | __________________________________________________________________________|____________| Intestine Large, Rectum | + + + + A A + + A + | 47 | __________________________________________________________________________|____________| Intestine Large, Cecum | + + + + A A + + A + | 45 | __________________________________________________________________________|____________| Intestine Small, Duodenum | + + + + A + + + + + | 53 | __________________________________________________________________________|____________| Intestine Small, Jejunum | + + + + A A + + A + | 45 | __________________________________________________________________________|____________| Intestine Small, Ileum | + + + + A A + + A + | 45 | __________________________________________________________________________|____________| Liver | + + + + + + + + + + | 60 | Basophilic Focus | X 1 X 1 | 23 1.1| Clear Cell Focus | X X X X | 13 1.0| Degeneration, Cystic | | 4 2.0| Eosinophilic Focus | | 4 2.5| Fatty Change, Diffuse | 2 2 2 3 2 | 37 1.8| Fatty Change, Focal | | 1 1.0| Hepatodiaphragmatic Nodule | X | 1 | Hyperplasia | | 1 2.0| Mixed Cell Focus | | 11 1.0| Necrosis, Focal | | 1 2.0| Necrosis | | 1 2.0| Thrombosis | | 1 2.0| Bile Duct, Hyperplasia | | 12 2.2| Centrilobular, Hypertrophy | 1 | 8 1.0| __________________________________________________________________________|____________| Mesentery | | 3 | Fat, Fibrosis | | 1 2.0| Fat, Inflammation, Chronic Active | | 1 2.0| Fat, Necrosis | | 1 2.0| __________________________________________________________________________|____________| Pancreas | + + + + + + + + + + | 60 | __________________________________________________________________________|____________| Pharynx | | 2 | Inflammation, Acute | | 1 3.0| Palate, Inflammation, Acute | | 1 3.0| __________________________________________________________________________|____________| Salivary Glands | + + + + + + + + + + | 59 | Duct, Metaplasia, Squamous | | 2 1.0| __________________________________________________________________________|____________| Stomach, Forestomach | + + + + + + + + + + | 60 | Cyst Epithelial Inclusion | | 1 | Hyperkeratosis | | 4 2.5| Hyperplasia, Basal Cell | 2 | 6 2.0| __________________________________________________________________________________________________________________________________ * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 81 NTP Experiment-Test: 05108-01 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:43:56 __________________________________________________________________________________________________________________________________ | 7| 7| 6| 4| 2| 6| 7| 6| 5| 0| | | DAY ON TEST | 1| 0| 3| 6| 8| 2| 1| 2| 8| 5| | | | 7| 8| 9| 3| 9| 0| 7| 4| 3| 3| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| | A | 33.3 | 7| 7| 7| 7| 7| 8| 8| 8| 8| 8| | L | MG/KG | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| | | __________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - cont | | | | | | Hyperplasia, Squamous | | 1 4.0| Necrosis | | 1 2.0| Ulcer | | 4 2.3| __________________________________________________________________________|____________| Stomach, Glandular | + + + + A + + + + + | 54 | Necrosis | | 2 2.0| __________________________________________________________________________|____________| Tongue | | 1 | Hyperkeratosis | | 1 1.0| _____________________________________________________________________________________________________________________| | CARDIOVASCULAR SYSTEM | | | | | | __________________________________________________________________________|____________| Heart | + + + + + + + + + + | 60 | Cardiomyopathy | 2 2 2 1 2 2 2 2 2 1 | 52 2.0| Congestion | | 1 3.0| Mineralization | 1 | 2 1.0| _____________________________________________________________________________________________________________________| | ENDOCRINE SYSTEM | | | | | | __________________________________________________________________________|____________| Adrenal Cortex | + + + + + + + + + + | 60 | __________________________________________________________________________|____________| Adrenal Medulla | + + + + + + + + + + | 59 | Hyperplasia | 2 | 9 1.4| __________________________________________________________________________|____________| Islets, Pancreatic | + + + + + + + + + + | 58 | Hyperplasia | | 3 2.0| __________________________________________________________________________|____________| Parathyroid Gland | + + + + + + + + + + | 56 | Hyperplasia | | 3 2.0| __________________________________________________________________________|____________| Pituitary Gland | + + + + + + + + + I | 59 | Pars Distalis, Angiectasis | | 3 2.0| Pars Distalis, Hyperplasia | 2 1 | 9 2.0| Pars Distalis, Infarct | | 1 3.0| __________________________________________________________________________|____________| Thyroid Gland | + + + + + + + + + + | 50 | C-Cell, Hyperplasia | | 1 1.0| Follicle, Cyst | | 1 | Follicular Cell, Hyperplasia | 2 | 1 2.0| _____________________________________________________________________________________________________________________| | GENERAL BODY SYSTEM | | | | | | None | | | _____________________________________________________________________________________________________________________| | GENITAL SYSTEM | | | | | | __________________________________________________________________________|____________| Epididymis | + + + + + + + + + + | 60 | __________________________________________________________________________|____________| Preputial Gland | + + + M + + + + + + | 58 | Hyperplasia | 2 | 1 2.0| __________________________________________________________________________|____________| Prostate | M + M + + + + + + + | 57 | __________________________________________________________________________________________________________________________________ * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 82 NTP Experiment-Test: 05108-01 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:43:56 __________________________________________________________________________________________________________________________________ | 7| 7| 6| 4| 2| 6| 7| 6| 5| 0| | | DAY ON TEST | 1| 0| 3| 6| 8| 2| 1| 2| 8| 5| | | | 7| 8| 9| 3| 9| 0| 7| 4| 3| 3| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| | A | 33.3 | 7| 7| 7| 7| 7| 8| 8| 8| 8| 8| | L | MG/KG | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| | | __________________________________________________________________________________________________________________________________ GENITAL SYSTEM - cont | | | | | | Inflammation, Chronic Active | | 2 2.0| __________________________________________________________________________|____________| Seminal Vesicle | + + + + + + + + + + | 60 | __________________________________________________________________________|____________| Testes | + + + + + + + + + + | 60 | Interstitial Cell, Hyperplasia | 2 | 14 1.8| Seminiferous Tubule, Atrophy | | 8 2.8| _____________________________________________________________________________________________________________________| | HEMATOPOIETIC SYSTEM | | | | | | __________________________________________________________________________|____________| Blood | | 7 | __________________________________________________________________________|____________| Bone Marrow | + + M + + + + + + + | 59 | __________________________________________________________________________|____________| Lymph Node | + | 5 | __________________________________________________________________________|____________| Lymph Node, Mandibular | + + + + + + + + + + | 59 | __________________________________________________________________________|____________| Lymph Node, Mesenteric | + + + + + + + + + + | 59 | __________________________________________________________________________|____________| Spleen | + + + + + + + + + + | 60 | Cyst | | 1 | Fibrosis | | 4 1.8| __________________________________________________________________________|____________| Thymus | + + + + + + M + + + | 55 | _____________________________________________________________________________________________________________________| | INTEGUMENTARY SYSTEM | | | | | | __________________________________________________________________________|____________| Mammary Gland | + + + M M + + + + M | 46 | Galactocele | | 2 | Acinus, Hyperplasia | | 1 2.0| __________________________________________________________________________|____________| Skin | + + + + + + + + + + | 60 | Acanthosis | | 1 2.0| Hyperkeratosis | | 1 4.0| _____________________________________________________________________________________________________________________| | MUSCULOSKELETAL SYSTEM | | | | | | __________________________________________________________________________|____________| Bone | + + M + + + + + + + | 59 | __________________________________________________________________________|____________| Skeletal Muscle | | 1 | Edema | | 1 2.0| Hemorrhage | | 1 3.0| _____________________________________________________________________________________________________________________| | NERVOUS SYSTEM | | | | | | __________________________________________________________________________|____________| Brain | + + + + + + + + + + | 60 | _____________________________________________________________________________________________________________________| | RESPIRATORY SYSTEM | | | | | | __________________________________________________________________________|____________| Lung | + + + + + + + + + + | 60 | Edema | 1 | 5 2.2| Hemorrhage | 2 | 1 2.0| Infiltration Cellular, Histiocyte | | 1 2.0| __________________________________________________________________________________________________________________________________ * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 83 NTP Experiment-Test: 05108-01 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: CHRONIC PROMETHAZINE HYDROCHLORIDE Date: 04/25/97 Route: GAVAGE Time: 08:43:56 __________________________________________________________________________________________________________________________________ | 7| 7| 6| 4| 2| 6| 7| 6| 5| 0| | | DAY ON TEST | 1| 0| 3| 6| 8| 2| 1| 2| 8| 5| | | | 7| 8| 9| 3| 9| 0| 7| 4| 3| 3| | T (*) | _____________________________________________________________________________________________________________________| | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | FISCHER 344 RATS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| | A | 33.3 | 7| 7| 7| 7| 7| 8| 8| 8| 8| 8| | L | MG/KG | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| | | __________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM - cont | | | | | | Inflammation, Acute | | 4 2.8| Mediastinum, Inflammation, Chronic | | | Active | | 1 2.0| __________________________________________________________________________|____________| Nose | + + + + + + + + + + | 60 | Fungus | | 5 2.0| Inflammation, Acute | 1 | 9 2.2| __________________________________________________________________________|____________| Trachea | + + + + + + + + + + | 60 | Erosion | | 1 4.0| Inflammation, Acute | | 1 2.0| _____________________________________________________________________________________________________________________| | SPECIAL SENSES SYSTEM | | | | | | __________________________________________________________________________|____________| Eye | + | 2 | __________________________________________________________________________|____________| Zymbal's Gland | | 1 | _____________________________________________________________________________________________________________________| | URINARY SYSTEM | | | | | | __________________________________________________________________________|____________| Kidney | + + + + + + + + + + | 60 | Cyst | X | 4 | Hemorrhage | | 1 4.0| Mineralization | 2 | 1 2.0| Nephropathy | 3 4 3 2 1 3 3 3 2 | 56 2.7| Renal Tubule, Hyperplasia | | 1 2.0| __________________________________________________________________________|____________| Urinary Bladder | + + + + + + + + + + | 57 | Calculus Gross Observation | | 1 | Calculus Micro Observation Only | | 1 | Dilatation | 2 | 1 2.0| __________________________________________________________________________________________________________________________________ * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 84 ------------------------------------------------------------ ---------- END OF REPORT ---------- ------------------------------------------------------------