TDMS Study 55323-04 Pathology Tables
NTP Experiment-Test: 55323-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC LAURIC ACID DIETHANOLAMINE CONDENSATE Date: 07/30/97 Route: SKIN APPLICATION Time: 07:26:42 2 YEAR CHRONIC Facility: Battelle Columbus Laboratory Chemical CAS #: 120-40-1 Lock Date: 07/13/95 Cage Range: All Reasons For Removal: All Removal Date Range: All Treatment Groups: Include All a Number of animals examined microscopically at site and number of animals with lesion Page 1 NTP Experiment-Test: 55323-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC LAURIC ACID DIETHANOLAMINE CONDENSATE Date: 07/30/97 Route: SKIN APPLICATION Time: 07:26:42 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0 MG/KG 100 200 MG/KG MG/KG ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 50 50 50 Early Deaths Natural Death 4 2 5 Moribund Sacrifice 9 7 15 Accidently Killed 1 Survivors Terminal Sacrifice 37 40 29 Missing 1 Animals Examined Microscopically 50 49 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Esophagus (50) (49) (50) Inflammation, Chronic Active 1 (2%) Intestine Small, Duodenum (50) (49) (50) Hyperplasia 1 (2%) Ulcer 2 (4%) Liver (50) (49) (50) Angiectasis 1 (2%) Clear Cell Focus 2 (4%) 2 (4%) 1 (2%) Degeneration, Fatty, Focal 2 (4%) Eosinophilic Focus 15 (30%) 20 (41%) 23 (46%) Hematopoietic Cell Proliferation 1 (2%) Hepatodiaphragmatic Nodule 1 (2%) Infarct 1 (2%) Mixed Cell Focus 2 (4%) Necrosis, Focal 2 (4%) Bile Duct, Cyst 1 (2%) Mesentery (7) (10) (4) Fat, Necrosis 7 (100%) 10 (100%) 3 (75%) Pancreas (50) (49) (50) Infiltration Cellular, Lymphocyte 1 (2%) Inflammation, Chronic 1 (2%) Acinus, Atrophy 1 (2%) 2 (4%) Stomach, Forestomach (50) (49) (50) Ulcer 3 (6%) Epithelium, Hyperkeratosis 2 (4%) Stomach, Glandular (50) (49) (50) Inflammation, Chronic 1 (2%) Ulcer 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 2 NTP Experiment-Test: 55323-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC LAURIC ACID DIETHANOLAMINE CONDENSATE Date: 07/30/97 Route: SKIN APPLICATION Time: 07:26:42 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0 MG/KG 100 200 MG/KG MG/KG ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (50) (49) (50) Artery, Inflammation, Chronic 1 (2%) Atrium, Thrombosis 1 (2%) 1 (2%) Myocardium, Degeneration 5 (10%) 10 (20%) 5 (10%) Myocardium, Mineralization, Focal 1 (2%) Ventricle, Inflammation, Chronic, Focal 1 (2%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (50) (49) (50) Accessory Adrenal Cortical Nodule 1 (2%) Hyperplasia, Focal 1 (2%) 4 (8%) Necrosis, Acute 1 (2%) Adrenal Medulla (50) (49) (50) Hyperplasia, Focal 2 (4%) 2 (4%) 2 (4%) Necrosis 1 (2%) Islets, Pancreatic (50) (49) (50) Hyperplasia 2 (4%) 9 (18%) 6 (12%) Pituitary Gland (47) (49) (50) Pars Distalis, Angiectasis, Focal 1 (2%) Pars Distalis, Hyperplasia, Focal 11 (23%) 6 (12%) 11 (22%) Pars Distalis, Necrosis, Focal 1 (2%) Thyroid Gland (50) (49) (50) Inflammation, Chronic 1 (2%) C-Cell, Hyperplasia 2 (4%) Follicle, Hyperplasia, Diffuse 1 (2%) Follicle, Hyperplasia, Focal 38 (76%) 34 (69%) 36 (72%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Clitoral Gland (49) (47) (49) Cyst 1 (2%) 1 (2%) 1 (2%) Ovary (50) (49) (50) Angiectasis 1 (2%) 1 (2%) Cyst 6 (12%) 9 (18%) 8 (16%) Thrombosis 1 (2%) 1 (2%) Uterus (50) (49) (50) Angiectasis 1 (2%) 1 (2%) 2 (4%) Inflammation, Granulomatous 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 3 NTP Experiment-Test: 55323-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC LAURIC ACID DIETHANOLAMINE CONDENSATE Date: 07/30/97 Route: SKIN APPLICATION Time: 07:26:42 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0 MG/KG 100 200 MG/KG MG/KG ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM - CONT Endometrium, Hyperplasia, Cystic 38 (76%) 46 (94%) 39 (78%) Myometrium, Hyperplasia 1 (2%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Lymph Node (5) (4) (7) Mediastinal, Hyperplasia, Lymphoid 1 (20%) 1 (25%) Renal, Hyperplasia, Lymphoid 1 (20%) 1 (25%) Lymph Node, Mandibular (46) (48) (48) Hyperplasia, Lymphoid 1 (2%) Lymph Node, Mesenteric (49) (48) (47) Angiectasis 1 (2%) Hyperplasia, Lymphoid 1 (2%) Spleen (50) (49) (50) Hematopoietic Cell Proliferation 7 (14%) 6 (12%) 9 (18%) Hyperplasia, Lymphoid 6 (12%) 3 (6%) 1 (2%) Thymus (50) (47) (50) Ectopic Parathyroid Gland 1 (2%) Hemorrhage 1 (2%) Hyperplasia, Lymphoid 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Skin (50) (49) (50) Epidermis, Skin, Site of Application, Hyperplasia 42 (86%) 50 (100%) Sebaceous Gland, Skin, Site of Application, Hyperplasia 43 (88%) 45 (90%) Skin, Site of Application, Hyperkeratosis 4 (8%) 41 (84%) 48 (96%) Skin, Site of Application, Inflammation, Chronic Active 24 (49%) 40 (80%) Skin, Site of Application, Parakeratosis 3 (6%) 9 (18%) Skin, Site of Application, Ulcer 3 (6%) Subcutaneous Tissue, Edema 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (50) (49) (50) Fibrosis 1 (2%) 3 (6%) Fibrous Osteodystrophy 1 (2%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 4 NTP Experiment-Test: 55323-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC LAURIC ACID DIETHANOLAMINE CONDENSATE Date: 07/30/97 Route: SKIN APPLICATION Time: 07:26:42 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0 MG/KG 100 200 MG/KG MG/KG ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (49) (50) Meninges, Infiltration Cellular, Mixed Cell 1 (2%) Spinal Cord (1) Axon, Nerve, Degeneration 1 (100%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (49) (50) Hemorrhage, Focal 1 (2%) 1 (2%) Inflammation, Granulomatous 1 (2%) Thrombosis 1 (2%) Alveolar Epithelium, Hyperplasia, Focal 2 (4%) 1 (2%) 1 (2%) Mediastinum, Inflammation, Chronic Active 1 (2%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM None ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (49) (50) Infarct 1 (2%) Nephropathy 19 (38%) 30 (61%) 16 (32%) Urinary Bladder (50) (49) (50) Artery, Inflammation, Chronic 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 5 NTP Experiment-Test: 55323-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC LAURIC ACID DIETHANOLAMINE CONDENSATE Date: 07/30/97 Route: SKIN APPLICATION Time: 07:26:42 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0 MG/KG 100 200 MG/KG MG/KG ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 50 50 50 Early Deaths Moribund Sacrifice 7 6 7 Natural Death 3 7 2 Survivors Terminal Sacrifice 40 37 41 Animals Examined Microscopically 50 50 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Small, Jejunum (50) (50) (50) Peyer's Patch, Hyperplasia, Lymphoid 1 (2%) Liver (50) (50) (50) Basophilic Focus 1 (2%) 2 (4%) 1 (2%) Clear Cell Focus 14 (28%) 7 (14%) 6 (12%) Eosinophilic Focus 15 (30%) 9 (18%) 15 (30%) Fibrosis, Focal 1 (2%) Hepatodiaphragmatic Nodule 2 (4%) Mixed Cell Focus 2 (4%) 5 (10%) 2 (4%) Necrosis, Focal 1 (2%) 3 (6%) Bile Duct, Cyst 2 (4%) Bile Duct, Hyperplasia 1 (2%) Hepatocyte, Centrilobular, Hypertrophy 1 (2%) 1 (2%) Mesentery (1) (2) Artery, Inflammation, Chronic 1 (100%) Fat, Necrosis 2 (100%) Pancreas (50) (50) (50) Inflammation, Chronic 1 (2%) Stomach, Forestomach (50) (50) (50) Hemorrhage 1 (2%) Hyperkeratosis 1 (2%) 1 (2%) Hyperplasia, Focal 1 (2%) Ulcer 1 (2%) 1 (2%) Stomach, Glandular (50) (50) (50) Ulcer 1 (2%) Epithelium, Hyperplasia, Focal 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (50) (50) (50) Artery, Inflammation, Chronic 1 (2%) 1 (2%) Myocardium, Degeneration 5 (10%) 3 (6%) 8 (16%) Myocardium, Mineralization 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 6 NTP Experiment-Test: 55323-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC LAURIC ACID DIETHANOLAMINE CONDENSATE Date: 07/30/97 Route: SKIN APPLICATION Time: 07:26:42 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0 MG/KG 100 200 MG/KG MG/KG ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (50) (50) (50) Accessory Adrenal Cortical Nodule 1 (2%) Angiectasis 1 (2%) Hyperplasia, Focal 30 (60%) 17 (34%) 24 (48%) Hypertrophy 1 (2%) 1 (2%) Inflammation, Chronic 1 (2%) Adrenal Medulla (50) (50) (49) Hyperplasia, Focal 2 (4%) Islets, Pancreatic (50) (50) (50) Hyperplasia 27 (54%) 28 (56%) 12 (24%) Parathyroid Gland (40) (42) (43) Cyst 1 (3%) Pituitary Gland (48) (49) (50) Angiectasis 1 (2%) Pars Distalis, Hyperplasia, Focal 1 (2%) 1 (2%) Thyroid Gland (50) (50) (50) Follicle, Hyperplasia, Focal 18 (36%) 24 (48%) 36 (72%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Epididymis (50) (50) (50) Granuloma Sperm 1 (2%) Preputial Gland (50) (50) (50) Cyst 23 (46%) 19 (38%) 16 (32%) Hyperplasia 1 (2%) Inflammation, Granulomatous 1 (2%) Inflammation, Suppurative 1 (2%) Bilateral, Cyst 2 (4%) Seminal Vesicle (50) (50) (50) Fibrosis 1 (2%) 1 (2%) Inflammation, Chronic 1 (2%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Lymph Node, Mesenteric (49) (49) (50) Hyperplasia, Lymphoid 2 (4%) 2 (4%) Spleen (50) (50) (50) Hematopoietic Cell Proliferation 6 (12%) 7 (14%) 2 (4%) a Number of animals examined microscopically at site and number of animals with lesion Page 7 NTP Experiment-Test: 55323-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC LAURIC ACID DIETHANOLAMINE CONDENSATE Date: 07/30/97 Route: SKIN APPLICATION Time: 07:26:42 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0 MG/KG 100 200 MG/KG MG/KG ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - CONT Hyperplasia, Lymphoid 3 (6%) 2 (4%) Thymus (45) (45) (49) Hyperplasia 1 (2%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Skin (50) (50) (50) Hyperkeratosis 1 (2%) Epidermis, Skin, Site of Application, Hyperplasia 4 (8%) 45 (90%) 50 (100%) Pinna, Fibrosis, Focal 1 (2%) Sebaceous Gland, Skin, Site of Application, Hyperplasia 1 (2%) 45 (90%) 48 (96%) Skin, Site of Application, Hyperkeratosis 3 (6%) 45 (90%) 49 (98%) Skin, Site of Application, Inflammation, Chronic Active 1 (2%) 13 (26%) 28 (56%) Skin, Site of Application, Parakeratosis 1 (2%) 5 (10%) Skin, Site of Application, Ulcer 2 (4%) Subcutaneous Tissue, Edema 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM None ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM None ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (50) (50) Inflammation, Granulomatous 1 (2%) Thrombosis 1 (2%) Alveolar Epithelium, Hyperplasia, Focal 1 (2%) 3 (6%) 2 (4%) Mediastinum, Infiltration Cellular, Mast Cell 1 (2%) Nose (50) (50) (50) Inflammation, Suppurative 2 (4%) Polyp, Inflammatory 2 (4%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 8 NTP Experiment-Test: 55323-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC LAURIC ACID DIETHANOLAMINE CONDENSATE Date: 07/30/97 Route: SKIN APPLICATION Time: 07:26:42 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0 MG/KG 100 200 MG/KG MG/KG ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (3) Degeneration 1 (33%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (50) (50) Infarct 1 (2%) Nephropathy 28 (56%) 31 (62%) 33 (66%) Artery, Inflammation, Chronic 1 (2%) Renal Tubule, Cyst 2 (4%) 2 (4%) a Number of animals examined microscopically at site and number of animals with lesion Page 9 ------------------------------------------------------------ ---------- END OF REPORT ---------- ------------------------------------------------------------