TDMS Study 55312-04 Pathology Tables
NTP Experiment-Test: 55312-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC COCONUT OIL ACID DIETHANOLAMINE CONDENSATE Date: 09/18/97 Route: SKIN APPLICATION Time: 08:14:59 2 YEAR CHRONIC Facility: Battelle Columbus Laboratory Chemical CAS #: 68603-42-9 Lock Date: 09/06/95 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: 55312-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC COCONUT OIL ACID DIETHANOLAMINE CONDENSATE Date: 09/18/97 Route: SKIN APPLICATION Time: 08:14:59 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0 MG/KG 100 200 MG/KG MG/KG ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 50 50 50 Early Deaths Moribund Sacrifice 11 11 15 Natural Death 4 3 9 Survivors Terminal Sacrifice 35 35 26 Natural Death 1 Animals Examined Microscopically 50 50 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Esophagus (50) (50) (50) Inflammation 1 (2%) Intestine Large, Rectum (50) (50) (50) Hemorrhage 1 (2%) Intestine Small, Duodenum (50) (50) (50) Erosion 2 (4%) Ulcer 1 (2%) 1 (2%) Intestine Small, Jejunum (49) (50) (50) Hyperplasia, Lymphoid 1 (2%) 2 (4%) Inflammation 1 (2%) Ulcer 1 (2%) Mucosa, Hyperplasia 1 (2%) Liver (50) (50) (50) Angiectasis 1 (2%) 1 (2%) Basophilic Focus 2 (4%) Clear Cell Focus 2 (4%) 2 (4%) 2 (4%) Eosinophilic Focus 18 (36%) 25 (50%) 24 (48%) Fibrosis 2 (4%) 1 (2%) Inflammation, Suppurative 1 (2%) Mixed Cell Focus 1 (2%) 5 (10%) Necrosis 2 (4%) 5 (10%) 8 (16%) Bile Duct, Hyperplasia 1 (2%) 1 (2%) Mesentery (12) (9) (8) Fat, Inflammation 2 (17%) Fat, Necrosis 9 (75%) 8 (89%) 7 (88%) Pancreas (50) (50) (50) Atrophy 1 (2%) 4 (8%) 1 (2%) Hypertrophy 1 (2%) Hypertrophy, Focal 3 (6%) 1 (2%) 1 (2%) Duct, Cyst 2 (4%) 1 (2%) Stomach, Forestomach (50) (50) (50) Erosion 1 (2%) 1 (2%) Hyperplasia, Focal 2 (4%) 2 (4%) 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 2 NTP Experiment-Test: 55312-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC COCONUT OIL ACID DIETHANOLAMINE CONDENSATE Date: 09/18/97 Route: SKIN APPLICATION Time: 08:14:59 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0 MG/KG 100 200 MG/KG MG/KG ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Inflammation 1 (2%) Ulcer 1 (2%) Stomach, Glandular (50) (50) (50) Erosion 1 (2%) 2 (4%) Inflammation 2 (4%) Mineralization 2 (4%) 1 (2%) 1 (2%) Ulcer 1 (2%) Tooth (1) Inflammation 1 (100%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (50) (50) (50) Infiltration Cellular, Mononuclear Cell 1 (2%) Mineralization 1 (2%) 1 (2%) 1 (2%) Artery, Inflammation 1 (2%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (50) (50) (50) Hematopoietic Cell Proliferation 1 (2%) Hyperplasia 1 (2%) 1 (2%) Hypertrophy 1 (2%) Vacuolization Cytoplasmic 1 (2%) Capsule, Hyperplasia 2 (4%) Adrenal Medulla (50) (50) (50) Hyperplasia 2 (4%) 1 (2%) 2 (4%) Islets, Pancreatic (50) (50) (50) Hyperplasia 1 (2%) 2 (4%) Parathyroid Gland (37) (42) (43) Cyst 1 (3%) Hyperplasia, Focal 1 (2%) Pituitary Gland (48) (50) (49) Angiectasis 1 (2%) Pars Distalis, Hyperplasia 28 (58%) 31 (62%) 27 (55%) Pars Intermedia, Hyperplasia 1 (2%) 1 (2%) Thyroid Gland (50) (50) (50) Follicular Cell, Hyperplasia 27 (54%) 36 (72%) 33 (66%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 3 NTP Experiment-Test: 55312-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC COCONUT OIL ACID DIETHANOLAMINE CONDENSATE Date: 09/18/97 Route: SKIN APPLICATION Time: 08:14:59 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0 MG/KG 100 200 MG/KG MG/KG ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Clitoral Gland (48) (49) (47) Inflammation 1 (2%) Ovary (50) (50) (50) Angiectasis 2 (4%) Cyst 15 (30%) 14 (28%) 15 (30%) Hemorrhage 2 (4%) 2 (4%) Mineralization 1 (2%) Granulosa Cell, Hyperplasia 1 (2%) 1 (2%) Uterus (50) (50) (50) Decidual Reaction 1 (2%) Hyperplasia 37 (74%) 26 (52%) 22 (44%) Inflammation, Suppurative 1 (2%) Thrombosis 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (50) (50) (50) Hyperplasia 7 (14%) 10 (20%) 19 (38%) Myelofibrosis 21 (42%) 21 (42%) 19 (38%) Lymph Node (7) (3) (6) Inguinal, Hematopoietic Cell Proliferation 1 (17%) Mediastinal, Hematopoietic Cell Proliferation 1 (17%) Renal, Hematopoietic Cell Proliferation 1 (17%) Lymph Node, Mandibular (49) (47) (49) Hematopoietic Cell Proliferation 2 (4%) Hyperplasia, Lymphoid 1 (2%) Hyperplasia, Plasma Cell 1 (2%) Lymph Node, Mesenteric (48) (50) (49) Angiectasis 1 (2%) 2 (4%) Hematopoietic Cell Proliferation 1 (2%) 2 (4%) Hyperplasia, Lymphoid 1 (2%) Hyperplasia, Plasma Cell 1 (2%) Inflammation 1 (2%) Spleen (50) (50) (50) Accessory Spleen 1 (2%) Hematopoietic Cell Proliferation 33 (66%) 33 (66%) 36 (72%) Lymphoid Follicle, Hyperplasia 1 (2%) 5 (10%) Thymus (47) (40) (41) Atrophy 7 (15%) 4 (10%) 8 (20%) Hyperplasia, Lymphoid 1 (2%) 2 (5%) 1 (2%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 4 NTP Experiment-Test: 55312-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC COCONUT OIL ACID DIETHANOLAMINE CONDENSATE Date: 09/18/97 Route: SKIN APPLICATION Time: 08:14:59 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0 MG/KG 100 200 MG/KG MG/KG ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Skin (50) (50) (50) Control, Edema 1 (2%) Control, Hyperkeratosis 1 (2%) Control, Inflammation 3 (6%) Control, Parakeratosis 1 (2%) Epidermis, Control, Hyperplasia 1 (2%) Epidermis, Skin, Site of Application, Hyperplasia 9 (18%) 47 (94%) 50 (100%) Sebaceous Gland, Skin, Site of Application, Hyperplasia 42 (84%) 48 (96%) Skin, Site of Application, Hyperkeratosis 5 (10%) 30 (60%) 40 (80%) Skin, Site of Application, Inflammation 3 (6%) 2 (4%) 11 (22%) Skin, Site of Application, Parakeratosis 3 (6%) 4 (8%) 16 (32%) Skin, Site of Application, Ulcer 1 (2%) 3 (6%) Subcutaneous Tissue, Control, Hemorrhage 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (50) (50) (50) Osteomalacia 1 (2%) Joint, Inflammation, Chronic 1 (2%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (50) (50) Cyst Epithelial Inclusion 1 (2%) Neuron, Necrosis 2 (4%) 3 (6%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (50) (50) Inflammation 2 (4%) 1 (2%) Alveolar Epithelium, Hyperplasia 1 (2%) 1 (2%) 2 (4%) Nose (50) (50) (49) Inflammation 1 (2%) 2 (4%) Nasolacrimal Duct, Inflammation 1 (2%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 5 NTP Experiment-Test: 55312-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC COCONUT OIL ACID DIETHANOLAMINE CONDENSATE Date: 09/18/97 Route: SKIN APPLICATION Time: 08:14:59 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0 MG/KG 100 200 MG/KG MG/KG ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (1) (2) (1) Degeneration 1 (50%) Cornea, Inflammation 1 (100%) 1 (100%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (50) (50) Accumulation, Hyaline Droplet 2 (4%) 1 (2%) Cyst 1 (2%) Hydronephrosis 1 (2%) 1 (2%) 1 (2%) Mineralization 2 (4%) Nephropathy 27 (54%) 24 (48%) 15 (30%) Pigmentation, Hemosiderin 1 (2%) 2 (4%) Pigmentation, Hemoglobin 1 (2%) Glomerulus, Thrombosis 1 (2%) Renal Tubule, Degeneration 1 (2%) Urinary Bladder (50) (50) (50) Inflammation 1 (2%) Transitional Epithelium, Hyperplasia 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 6 NTP Experiment-Test: 55312-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC COCONUT OIL ACID DIETHANOLAMINE CONDENSATE Date: 09/18/97 Route: SKIN APPLICATION Time: 08:14:59 ____________________________________________________________________________________________________________________________________ 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 5 7 7 Natural Death 4 6 7 Survivors Terminal Sacrifice 41 37 36 Animals Examined Microscopically 50 50 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Small, Duodenum (49) (50) (50) Ulcer 1 (2%) Intestine Small, Jejunum (50) (50) (50) Inflammation 1 (2%) Lymphatic, Hyperplasia 1 (2%) Liver (50) (50) (50) Angiectasis 1 (2%) Basophilic Focus 3 (6%) Clear Cell Focus 8 (16%) 8 (16%) 4 (8%) Degeneration, Cystic 1 (2%) Eosinophilic Focus 20 (40%) 29 (58%) 31 (62%) Hematopoietic Cell Proliferation 1 (2%) 1 (2%) Mixed Cell Focus 6 (12%) 7 (14%) 6 (12%) Necrosis 1 (2%) 3 (6%) 2 (4%) Bile Duct, Hyperplasia 1 (2%) Mesentery (3) (3) (4) Artery, Inflammation 1 (25%) Fat, Necrosis 1 (33%) 1 (33%) 2 (50%) Pancreas (50) (50) (50) Atrophy 2 (4%) 2 (4%) 5 (10%) Hypertrophy, Focal 1 (2%) Inflammation, Granulomatous 1 (2%) Duct, Cyst 1 (2%) 1 (2%) Duct, Hyperplasia 1 (2%) Salivary Glands (50) (50) (50) Inflammation 1 (2%) Inflammation, Granulomatous 1 (2%) Stomach, Forestomach (50) (50) (50) Hyperplasia, Focal 1 (2%) 1 (2%) Ulcer 1 (2%) Stomach, Glandular (50) (50) (50) Dysplasia 1 (2%) Erosion 1 (2%) Hyperplasia 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 7 NTP Experiment-Test: 55312-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC COCONUT OIL ACID DIETHANOLAMINE CONDENSATE Date: 09/18/97 Route: SKIN APPLICATION Time: 08:14:59 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0 MG/KG 100 200 MG/KG MG/KG ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Inflammation, Granulomatous 1 (2%) Tooth (1) Inflammation 1 (100%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Blood Vessel (50) (50) (50) Aorta, Inflammation 1 (2%) Heart (50) (50) (50) Degeneration 3 (6%) Artery, Inflammation 1 (2%) Atrium, Thrombosis 1 (2%) Coronary Artery, Thrombosis 1 (2%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (50) (50) (50) Angiectasis 1 (2%) Hyperplasia 3 (6%) 6 (12%) 3 (6%) Hypertrophy 28 (56%) 30 (60%) 26 (52%) Necrosis 1 (2%) Capsule, Hyperplasia 8 (16%) 15 (30%) 11 (22%) Adrenal Medulla (50) (50) (50) Hyperplasia 2 (4%) 2 (4%) Islets, Pancreatic (50) (50) (50) Hyperplasia 21 (42%) 23 (46%) 21 (42%) Pituitary Gland (45) (47) (49) Cyst 2 (4%) 3 (6%) Pars Distalis, Hyperplasia 4 (9%) 2 (4%) 4 (8%) Pars Intermedia, Hyperplasia 1 (2%) 1 (2%) Thyroid Gland (50) (50) (50) Follicular Cell, Hyperplasia 11 (22%) 20 (40%) 23 (46%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Epididymis (50) (50) (50) Granuloma Sperm 2 (4%) 1 (2%) 2 (4%) Penis (1) Congestion 1 (100%) a Number of animals examined microscopically at site and number of animals with lesion Page 8 NTP Experiment-Test: 55312-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC COCONUT OIL ACID DIETHANOLAMINE CONDENSATE Date: 09/18/97 Route: SKIN APPLICATION Time: 08:14:59 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0 MG/KG 100 200 MG/KG MG/KG ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM - CONT Preputial Gland (49) (50) (50) Cyst 21 (43%) 21 (42%) 14 (28%) Inflammation 1 (2%) 1 (2%) Prostate (50) (50) (50) Inflammation 1 (2%) 1 (2%) Seminal Vesicle (50) (49) (50) Inflammation, Granulomatous 1 (2%) Testes (50) (50) (50) Atrophy 2 (4%) 2 (4%) 1 (2%) Mineralization 1 (2%) Interstitial Cell, Hyperplasia 1 (2%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (50) (50) (50) Hyperplasia 10 (20%) 10 (20%) 19 (38%) Lymph Node, Mandibular (47) (45) (44) Hematopoietic Cell Proliferation 1 (2%) Lymph Node, Mesenteric (46) (48) (47) Angiectasis 1 (2%) 1 (2%) 1 (2%) Atrophy 2 (4%) Hematopoietic Cell Proliferation 2 (4%) 2 (4%) 3 (6%) Hemorrhage 1 (2%) Hyperplasia, Lymphoid 1 (2%) 2 (4%) Inflammation, Granulomatous 1 (2%) Spleen (50) (50) (50) Angiectasis 1 (2%) Fibrosis 1 (2%) Hematopoietic Cell Proliferation 25 (50%) 23 (46%) 30 (60%) Thymus (43) (44) (41) Atrophy 13 (30%) 13 (30%) 14 (34%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Skin (50) (50) (50) Control, Edema 1 (2%) Control, Infiltration Cellular, Mast Cell 1 (2%) Epidermis, Skin, Site of Application, Hyperplasia 5 (10%) 47 (94%) 50 (100%) Lymphatic, Angiectasis 1 (2%) Sebaceous Gland, Skin, Site of Application, Hyperplasia 44 (88%) 49 (98%) Skin, Site of Application, Hyperkeratosis 24 (48%) 23 (46%) Skin, Site of Application, Inflammation 2 (4%) 2 (4%) 2 (4%) Skin, Site of Application, Parakeratosis 1 (2%) 4 (8%) 5 (10%) a Number of animals examined microscopically at site and number of animals with lesion Page 9 NTP Experiment-Test: 55312-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC COCONUT OIL ACID DIETHANOLAMINE CONDENSATE Date: 09/18/97 Route: SKIN APPLICATION Time: 08:14:59 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0 MG/KG 100 200 MG/KG MG/KG ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM - CONT Skin, Site of Application, Ulcer 1 (2%) 7 (14%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (50) (50) (50) Hyperostosis 1 (2%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (50) (50) Neuron, Necrosis 1 (2%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (50) (50) Inflammation 1 (2%) 1 (2%) Inflammation, Granulomatous 1 (2%) Pigmentation, Hemosiderin 1 (2%) Alveolar Epithelium, Hyperplasia 4 (8%) 4 (8%) 1 (2%) Nose (50) (50) (50) Inflammation 1 (2%) 1 (2%) Nasolacrimal Duct, Inflammation 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (1) (2) (1) Cornea, Inflammation 2 (100%) 1 (100%) Harderian Gland (3) (3) (6) Hyperplasia 1 (33%) 1 (17%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (50) (50) Accumulation, Hyaline Droplet 1 (2%) 1 (2%) Cyst 12 (24%) 16 (32%) 11 (22%) Inflammation, Granulomatous 1 (2%) Inflammation, Suppurative 1 (2%) Nephropathy 47 (94%) 49 (98%) 50 (100%) Pigmentation, Hemosiderin 3 (6%) Artery, Inflammation 2 (4%) 1 (2%) Renal Tubule, Hyperplasia 1 (2%) 2 (4%) Ureter (1) (1) a Number of animals examined microscopically at site and number of animals with lesion Page 10 NTP Experiment-Test: 55312-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC COCONUT OIL ACID DIETHANOLAMINE CONDENSATE Date: 09/18/97 Route: SKIN APPLICATION Time: 08:14:59 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0 MG/KG 100 200 MG/KG MG/KG ____________________________________________________________________________________________________________________________________ URINARY SYSTEM - CONT Inflammation, Granulomatous 1 (100%) Urinary Bladder (50) (50) (50) Inflammation 1 (2%) Inflammation, Granulomatous 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 11 ------------------------------------------------------------ ---------- END OF REPORT ---------- ------------------------------------------------------------