TDMS Study 55312-03 Pathology Tables
NTP Experiment-Test: 55312-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC COCONUT OIL ACID DIETHANOLAMINE CONDENSATE Date: 01/28/99
Route: SKIN APPLICATION Time: 08:08:11
2 YEAR CHRONIC RATS
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: 55312-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC COCONUT OIL ACID DIETHANOLAMINE CONDENSATE Date: 01/28/99
Route: SKIN APPLICATION Time: 08:08:11
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 MG/KG 50 MG/KG 100
MG/KG
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 50 50 50
Early Deaths
Natural Death 15 11 18
Moribund Sacrifice 7 15 10
Survivors
Terminal Sacrifice 28 24 21
Moribund Sacrifice 1
Animals Examined Microscopically 50 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Esophagus (50) (50) (50)
Perforation 1 (2%)
Intestine Large, Colon (50) (50) (50)
Parasite Metazoan 2 (4%) 5 (10%) 1 (2%)
Intestine Large, Rectum (50) (50) (50)
Parasite Metazoan 6 (12%) 4 (8%) 6 (12%)
Intestine Large, Cecum (50) (50) (50)
Parasite Metazoan 2 (4%)
Intestine Small, Duodenum (50) (50) (50)
Epithelium, Ulcer 1 (2%)
Intestine Small, Jejunum (50) (50) (50)
Inflammation, Chronic Active 1 (2%)
Intestine Small, Ileum (50) (49) (49)
Inflammation, Chronic Active 1 (2%)
Liver (50) (50) (50)
Basophilic Focus 31 (62%) 17 (34%) 4 (8%)
Clear Cell Focus 5 (10%) 4 (8%) 1 (2%)
Fibrosis 1 (2%)
Hematopoietic Cell Proliferation 1 (2%)
Hepatodiaphragmatic Nodule 10 (20%) 11 (22%) 14 (28%)
Inflammation, Chronic 29 (58%) 26 (52%) 13 (26%)
Mixed Cell Focus 1 (2%) 2 (4%)
Pigmentation, Hemosiderin 1 (2%)
Vacuolization Cytoplasmic 23 (46%) 20 (40%) 22 (44%)
Bile Duct, Hyperplasia 26 (52%) 21 (42%) 16 (32%)
Hepatocyte, Degeneration, Cystic 1 (2%)
Hepatocyte, Hyperplasia, Adenomatous 1 (2%) 1 (2%)
Hepatocyte, Necrosis 1 (2%) 2 (4%)
Hepatocyte, Centrilobular, Degeneration 2 (4%) 1 (2%) 2 (4%)
Hepatocyte, Centrilobular, Necrosis 1 (2%)
Serosa, Necrosis, Fibrinoid 1 (2%)
Mesentery (4) (5) (2)
Fat, Inflammation, Chronic Active 1 (50%)
a Number of animals examined microscopically at site and number of animals with lesion
NTP Experiment-Test: 55312-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC COCONUT OIL ACID DIETHANOLAMINE CONDENSATE Date: 01/28/99
Route: SKIN APPLICATION Time: 08:08:11
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 MG/KG 50 MG/KG 100
MG/KG
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Fat, Necrosis 3 (75%) 4 (80%) 1 (50%)
Oral Mucosa (1) (1) (3)
Gingival, Hyperplasia, Squamous 1 (100%)
Gingival, Inflammation, Chronic Active 1 (33%)
Pharyngeal, Hyperplasia, Squamous 1 (100%) 1 (33%)
Pancreas (50) (50) (50)
Inflammation, Granulomatous 1 (2%)
Acinus, Atrophy 19 (38%) 13 (26%) 11 (22%)
Stomach, Forestomach (50) (50) (50)
Edema 1 (2%) 1 (2%) 2 (4%)
Inflammation, Chronic Active 1 (2%) 3 (6%) 10 (20%)
Mineralization 1 (2%)
Epithelium, Hyperplasia 2 (4%) 5 (10%) 13 (26%)
Epithelium, Ulcer 1 (2%) 3 (6%) 11 (22%)
Stomach, Glandular (50) (50) (50)
Mineralization 1 (2%) 1 (2%)
Epithelium, Erosion 1 (2%) 1 (2%)
Epithelium, Hyperplasia 1 (2%)
Epithelium, Ulcer 1 (2%)
Glands, Hyperplasia 1 (2%)
Tongue (1)
Hyperplasia, Squamous 1 (100%)
Tooth (1)
Inflammation, Chronic Active 1 (100%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Blood Vessel (50) (50) (50)
Aorta, Mineralization 1 (2%) 1 (2%)
Pulmonary Artery, Mineralization 1 (2%)
Heart (50) (50) (50)
Cardiomyopathy, Chronic 22 (44%) 16 (32%) 14 (28%)
Inflammation, Chronic Active 1 (2%)
Mineralization 1 (2%) 1 (2%)
Atrium, Thrombosis 1 (2%) 3 (6%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (50) (50) (50)
Accessory Adrenal Cortical Nodule 1 (2%)
Atrophy 1 (2%)
Degeneration, Cystic 8 (16%) 6 (12%) 8 (16%)
Degeneration, Fatty 22 (44%) 14 (28%) 16 (32%)
Fibrosis 1 (2%)
Hyperplasia 22 (44%) 14 (28%) 11 (22%)
a Number of animals examined microscopically at site and number of animals with lesion
NTP Experiment-Test: 55312-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC COCONUT OIL ACID DIETHANOLAMINE CONDENSATE Date: 01/28/99
Route: SKIN APPLICATION Time: 08:08:11
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 MG/KG 50 MG/KG 100
MG/KG
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM - CONT
Hypertrophy 10 (20%) 3 (6%) 7 (14%)
Necrosis 1 (2%)
Adrenal Medulla (50) (50) (50)
Hyperplasia 1 (2%) 2 (4%) 3 (6%)
Parathyroid Gland (42) (46) (45)
Hyperplasia 1 (2%) 3 (7%)
Pituitary Gland (50) (49) (50)
Pars Distalis, Cyst 23 (46%) 27 (55%) 17 (34%)
Pars Distalis, Hyperplasia 20 (40%) 19 (39%) 19 (38%)
Pars Intermedia, Cyst 1 (2%) 2 (4%) 2 (4%)
Thyroid Gland (50) (50) (50)
Ectopic Thymus 1 (2%)
C-Cell, Hyperplasia 17 (34%) 7 (14%) 7 (14%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Clitoral Gland (49) (50) (50)
Hyperplasia 4 (8%) 1 (2%) 3 (6%)
Inflammation, Chronic Active 6 (12%) 6 (12%) 8 (16%)
Bilateral, Duct, Cyst 1 (2%)
Duct, Cyst 2 (4%) 1 (2%) 1 (2%)
Ovary (50) (50) (50)
Cyst 7 (14%) 8 (16%) 8 (16%)
Uterus (50) (50) (50)
Dysplasia 1 (2%)
Inflammation, Suppurative 1 (2%)
Endometrium, Hyperplasia, Cystic 1 (2%)
Vagina (2)
Inflammation, Suppurative 1 (50%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (50) (50) (50)
Atrophy 1 (2%)
Hyperplasia 12 (24%) 14 (28%) 10 (20%)
Lymph Node (41) (36) (36)
Pigmentation, Hemosiderin 1 (2%)
Inguinal, Ectasia 1 (2%)
Mediastinal, Congestion 1 (3%)
Mediastinal, Pigmentation, Hemosiderin 38 (93%) 35 (97%) 34 (94%)
a Number of animals examined microscopically at site and number of animals with lesion
NTP Experiment-Test: 55312-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC COCONUT OIL ACID DIETHANOLAMINE CONDENSATE Date: 01/28/99
Route: SKIN APPLICATION Time: 08:08:11
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 MG/KG 50 MG/KG 100
MG/KG
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - CONT
Lymph Node, Mandibular (50) (48) (47)
Pigmentation, Hemosiderin 1 (2%)
Spleen (50) (50) (50)
Congestion 1 (2%)
Fibrosis 1 (2%)
Hematopoietic Cell Proliferation 3 (6%) 4 (8%) 1 (2%)
Necrosis 1 (2%)
Pigmentation, Hemosiderin 1 (2%)
Capsule, Fibrosis 1 (2%)
Capsule, Inflammation, Granulomatous 1 (2%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (49) (50) (50)
Cyst 3 (6%)
Hyperplasia, Cystic 44 (90%) 40 (80%) 40 (80%)
Skin (50) (50) (50)
Cyst Epithelial Inclusion 2 (4%)
Inflammation, Chronic Active 1 (2%) 2 (4%)
Inflammation, Suppurative 1 (2%)
Epidermis, Hyperplasia 1 (2%)
Epidermis, Skin, Site of Application,
Hyperkeratosis 3 (6%) 45 (90%) 47 (94%)
Epidermis, Skin, Site of Application,
Hyperplasia 3 (6%) 46 (92%) 50 (100%)
Epidermis, Skin, Site of Application,
Parakeratosis 1 (2%) 11 (22%) 23 (46%)
Epidermis, Skin, Site of Application, Ulcer 2 (4%) 9 (18%)
Sebaceous Gland, Skin, Site of Application,
Hyperplasia 2 (4%) 46 (92%) 49 (98%)
Skin, Site of Application, Inflammation,
Chronic Active 3 (6%) 6 (12%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (50) (50) (50)
Fibrous Osteodystrophy 2 (4%) 2 (4%)
Osteopetrosis 2 (4%) 2 (4%)
Skeletal Muscle (3) (1)
Inflammation, Chronic Active 1 (33%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
NTP Experiment-Test: 55312-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC COCONUT OIL ACID DIETHANOLAMINE CONDENSATE Date: 01/28/99
Route: SKIN APPLICATION Time: 08:08:11
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 MG/KG 50 MG/KG 100
MG/KG
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (50) (50)
Hemorrhage 1 (2%) 1 (2%)
Spinal Cord (1)
Hemorrhage 1 (100%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (50) (50)
Congestion 1 (2%)
Hemorrhage 1 (2%)
Inflammation, Chronic Active 7 (14%) 16 (32%) 9 (18%)
Inflammation, Granulomatous 3 (6%) 1 (2%) 1 (2%)
Metaplasia, Osseous 1 (2%)
Alveolar Epithelium, Hyperplasia 2 (4%) 1 (2%) 3 (6%)
Alveolus, Infiltration Cellular, Histiocyte 22 (44%) 24 (48%) 28 (56%)
Mediastinum, Necrosis 1 (2%)
Nose (50) (50) (50)
Inflammation, Chronic Active 1 (2%) 4 (8%) 3 (6%)
Nasolacrimal Duct, Inflammation, Suppurative 4 (8%) 3 (6%) 3 (6%)
Respiratory Epithelium, Hyperplasia 1 (2%) 4 (8%) 3 (6%)
Respiratory Epithelium, Metaplasia, Squamous 1 (2%) 2 (4%)
Vein, Turbinate, Septum, Thrombosis 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (6) (2) (5)
Anterior Chamber, Cornea, Iris, Synechia 1 (17%)
Bilateral, Inflammation, Suppurative 1 (20%)
Cornea, Inflammation, Chronic 1 (17%)
Lens, Cataract 5 (83%) 1 (50%) 4 (80%)
Retina, Atrophy 3 (50%) 1 (50%) 3 (60%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (50) (50)
Accumulation, Hyaline Droplet 2 (4%)
Cyst 2 (4%) 1 (2%)
Mineralization 50 (100%) 45 (90%) 47 (94%)
Nephropathy, Chronic 47 (94%) 46 (92%) 46 (92%)
Pigmentation, Hemosiderin 48 (96%) 46 (92%) 47 (94%)
Urinary Bladder (50) (50) (50)
a Number of animals examined microscopically at site and number of animals with lesion
NTP Experiment-Test: 55312-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC COCONUT OIL ACID DIETHANOLAMINE CONDENSATE Date: 01/28/99
Route: SKIN APPLICATION Time: 08:08:11
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 MG/KG 50 MG/KG 100
MG/KG
____________________________________________________________________________________________________________________________________
URINARY SYSTEM - CONT
Transitional Epithelium, Hyperplasia 1 (2%) 2 (4%)
a Number of animals examined microscopically at site and number of animals with lesion
NTP Experiment-Test: 55312-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC COCONUT OIL ACID DIETHANOLAMINE CONDENSATE Date: 01/28/99
Route: SKIN APPLICATION Time: 08:08:11
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 MG/KG 50 MG/KG 100
MG/KG
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 50 50 50
Early Deaths
Moribund Sacrifice 28 27 25
Natural Death 13 11 14
Accidently Killed 1
Survivors
Terminal Sacrifice 8 12 11
Animals Examined Microscopically 50 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Intestine Large, Colon (50) (50) (50)
Parasite Metazoan 2 (4%) 5 (10%) 1 (2%)
Intestine Large, Rectum (50) (50) (50)
Parasite Metazoan 2 (4%) 5 (10%)
Intestine Large, Cecum (50) (50) (50)
Inflammation, Chronic Active 2 (4%)
Parasite Metazoan 1 (2%)
Ulcer 1 (2%)
Intestine Small, Duodenum (50) (50) (50)
Epithelium, Ulcer 1 (2%)
Liver (50) (50) (50)
Basophilic Focus 3 (6%) 13 (26%) 3 (6%)
Clear Cell Focus 3 (6%) 6 (12%) 2 (4%)
Eosinophilic Focus 1 (2%)
Fibrosis 1 (2%)
Hepatodiaphragmatic Nodule 9 (18%) 9 (18%) 8 (16%)
Inflammation, Chronic 20 (40%) 25 (50%) 24 (48%)
Mineralization 1 (2%)
Vacuolization Cytoplasmic 27 (54%) 36 (72%) 33 (66%)
Bile Duct, Hyperplasia 47 (94%) 48 (96%) 50 (100%)
Hepatocyte, Degeneration, Cystic 8 (16%) 8 (16%) 3 (6%)
Hepatocyte, Necrosis 1 (2%) 3 (6%) 1 (2%)
Hepatocyte, Centrilobular, Degeneration 2 (4%) 1 (2%)
Hepatocyte, Centrilobular, Necrosis 2 (4%) 1 (2%)
Portal Vein, Thrombosis 1 (2%)
Mesentery (8) (7) (6)
Accessory Spleen 1 (14%)
Inflammation, Chronic Active 1 (13%) 1 (14%)
Fat, Necrosis 7 (88%) 3 (43%) 5 (83%)
Oral Mucosa (1) (2) (2)
Gingival, Hyperplasia 1 (50%)
Gingival, Inflammation, Chronic Active 1 (50%) 1 (50%)
Pharyngeal, Hyperplasia, Squamous 1 (50%)
a Number of animals examined microscopically at site and number of animals with lesion
NTP Experiment-Test: 55312-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC COCONUT OIL ACID DIETHANOLAMINE CONDENSATE Date: 01/28/99
Route: SKIN APPLICATION Time: 08:08:11
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 MG/KG 50 MG/KG 100
MG/KG
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Pancreas (50) (50) (50)
Acinus, Atrophy 11 (22%) 22 (44%) 25 (50%)
Artery, Inflammation, Chronic Active 1 (2%)
Salivary Glands (50) (50) (50)
Duct, Cyst 1 (2%)
Stomach, Forestomach (50) (50) (50)
Edema 6 (12%) 5 (10%) 8 (16%)
Foreign Body 1 (2%)
Inflammation, Chronic Active 15 (30%) 8 (16%) 14 (28%)
Mineralization 4 (8%) 2 (4%) 2 (4%)
Perforation 4 (8%) 2 (4%) 4 (8%)
Epithelium, Hyperplasia 18 (36%) 16 (32%) 18 (36%)
Epithelium, Ulcer 13 (26%) 7 (14%) 13 (26%)
Stomach, Glandular (50) (50) (50)
Inflammation, Chronic Active 1 (2%) 2 (4%)
Mineralization 7 (14%) 6 (12%) 4 (8%)
Epithelium, Erosion 2 (4%)
Epithelium, Ulcer 3 (6%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Blood Vessel (50) (50) (50)
Mineralization 1 (2%)
Aorta, Mineralization 6 (12%) 4 (8%) 4 (8%)
Pulmonary Artery, Mineralization 4 (8%) 2 (4%)
Heart (50) (50) (50)
Cardiomyopathy, Chronic 37 (74%) 43 (86%) 42 (84%)
Inflammation, Suppurative 1 (2%)
Mineralization 5 (10%) 3 (6%) 4 (8%)
Atrium, Thrombosis 6 (12%) 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (50) (50) (50)
Accessory Adrenal Cortical Nodule 2 (4%) 1 (2%)
Atypia Cellular 1 (2%)
Degeneration, Cystic 3 (6%) 4 (8%) 3 (6%)
Degeneration, Fatty 36 (72%) 40 (80%) 38 (76%)
Hyperplasia 13 (26%) 21 (42%) 24 (48%)
Hypertrophy 2 (4%) 6 (12%) 5 (10%)
Necrosis 1 (2%) 1 (2%)
Adrenal Medulla (50) (50) (50)
Hyperplasia 20 (40%) 19 (38%) 16 (32%)
Islets, Pancreatic (50) (50) (50)
Hyperplasia 1 (2%) 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
NTP Experiment-Test: 55312-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC COCONUT OIL ACID DIETHANOLAMINE CONDENSATE Date: 01/28/99
Route: SKIN APPLICATION Time: 08:08:11
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 MG/KG 50 MG/KG 100
MG/KG
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM - CONT
Parathyroid Gland (48) (46) (45)
Hyperplasia 14 (29%) 15 (33%) 8 (18%)
Pituitary Gland (50) (50) (49)
Pigmentation, Hematoidin 1 (2%)
Pars Distalis, Cyst 16 (32%) 7 (14%) 3 (6%)
Pars Distalis, Hyperplasia 13 (26%) 10 (20%) 12 (24%)
Pars Intermedia, Cyst 1 (2%) 1 (2%)
Thyroid Gland (50) (50) (50)
C-Cell, Hyperplasia 6 (12%) 11 (22%) 11 (22%)
Follicle, Cyst 2 (4%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Coagulating Gland (3)
Inflammation, Chronic Active 1 (33%)
Inflammation, Suppurative 2 (67%)
Epididymis (50) (50) (50)
Mineralization 1 (2%)
Preputial Gland (50) (50) (50)
Hyperplasia 3 (6%) 1 (2%) 3 (6%)
Inflammation, Chronic Active 47 (94%) 46 (92%) 46 (92%)
Prostate (50) (50) (50)
Cyst Multilocular 9 (18%) 8 (16%) 4 (8%)
Inflammation, Chronic Active 46 (92%) 47 (94%) 46 (92%)
Seminal Vesicle (50) (50) (50)
Dilatation 1 (2%)
Testes (50) (50) (50)
Arteriole, Inflammation, Chronic 9 (18%) 11 (22%) 13 (26%)
Arteriole, Necrosis, Fibrinoid 9 (18%) 10 (20%) 13 (26%)
Bilateral, Germinal Epithelium, Atrophy 1 (2%) 1 (2%)
Germinal Epithelium, Atrophy 10 (20%) 15 (30%) 16 (32%)
Interstitial Cell, Hyperplasia 12 (24%) 12 (24%) 13 (26%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (50) (50) (50)
Atrophy 1 (2%)
Hyperplasia 22 (44%) 22 (44%) 16 (32%)
Lymph Node (35) (30) (37)
Mediastinal, Hyperplasia, Lymphoid 1 (3%)
a Number of animals examined microscopically at site and number of animals with lesion
NTP Experiment-Test: 55312-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC COCONUT OIL ACID DIETHANOLAMINE CONDENSATE Date: 01/28/99
Route: SKIN APPLICATION Time: 08:08:11
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 MG/KG 50 MG/KG 100
MG/KG
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - CONT
Mediastinal, Pigmentation, Hemosiderin 29 (83%) 26 (87%) 33 (89%)
Lymph Node, Mandibular (50) (50) (50)
Ectasia 1 (2%)
Hyperplasia, Plasma Cell 1 (2%)
Lymph Node, Mesenteric (49) (50) (50)
Ectasia 1 (2%) 2 (4%)
Infiltration Cellular, Histiocyte 1 (2%)
Spleen (50) (50) (50)
Fibrosis 6 (12%) 5 (10%) 1 (2%)
Hematopoietic Cell Proliferation 1 (2%) 3 (6%) 3 (6%)
Hyperplasia 1 (2%)
Hyperplasia, Lymphoid 1 (2%)
Necrosis 1 (2%)
Red Pulp, Depletion Cellular 2 (4%) 1 (2%)
Thymus (47) (45) (48)
Ectopic Parathyroid Gland 1 (2%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (48) (49) (50)
Cyst 2 (4%) 6 (12%) 4 (8%)
Hyperplasia, Cystic 36 (75%) 44 (90%) 43 (86%)
Skin (50) (50) (50)
Cyst Epithelial Inclusion 1 (2%)
Inflammation, Chronic Active 2 (4%)
Epidermis, Hyperkeratosis 1 (2%)
Epidermis, Hyperplasia 1 (2%)
Epidermis, Skin, Site of Application,
Hyperkeratosis 36 (72%) 48 (96%)
Epidermis, Skin, Site of Application,
Hyperplasia 46 (92%) 50 (100%)
Epidermis, Skin, Site of Application,
Parakeratosis 9 (18%) 28 (56%)
Epidermis, Skin, Site of Application, Ulcer 1 (2%) 1 (2%)
Prepuce, Inflammation, Chronic Active 1 (2%)
Sebaceous Gland, Skin, Site of Application,
Hyperplasia 45 (90%) 50 (100%)
Skin, Site of Application, Hemorrhage 1 (2%)
Skin, Site of Application, Inflammation,
Chronic Active 1 (2%) 2 (4%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
NTP Experiment-Test: 55312-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC COCONUT OIL ACID DIETHANOLAMINE CONDENSATE Date: 01/28/99
Route: SKIN APPLICATION Time: 08:08:11
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 MG/KG 50 MG/KG 100
MG/KG
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (50) (50) (50)
Callus 1 (2%)
Fibrous Osteodystrophy 10 (20%) 12 (24%) 6 (12%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (50) (50)
Hemorrhage 1 (2%) 1 (2%) 1 (2%)
Mineralization 1 (2%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (50) (50)
Fibrosis 1 (2%) 1 (2%)
Hemorrhage 1 (2%)
Inflammation, Chronic Active 2 (4%) 8 (16%) 2 (4%)
Inflammation, Granulomatous 2 (4%)
Inflammation, Suppurative 1 (2%)
Mineralization 2 (4%)
Alveolar Epithelium, Hyperplasia 2 (4%) 4 (8%) 1 (2%)
Alveolus, Infiltration Cellular, Histiocyte 7 (14%) 13 (26%) 12 (24%)
Interstitium, Mineralization 2 (4%) 4 (8%) 2 (4%)
Nose (50) (50) (50)
Inflammation, Chronic Active 9 (18%) 7 (14%) 10 (20%)
Inflammation, Suppurative 1 (2%)
Nasolacrimal Duct, Inflammation, Suppurative 2 (4%) 4 (8%) 4 (8%)
Respiratory Epithelium, Hyperplasia 9 (18%) 7 (14%) 9 (18%)
Respiratory Epithelium, Metaplasia, Squamous 3 (6%) 2 (4%) 3 (6%)
Vein, Turbinate, Septum, Thrombosis 2 (4%) 2 (4%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (2) (3) (8)
Cornea, Inflammation, Chronic Active 1 (33%)
Cornea, Mineralization 1 (33%)
Lens, Cataract 2 (100%) 2 (67%) 8 (100%)
Retina, Atrophy 2 (100%) 2 (67%) 8 (100%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
NTP Experiment-Test: 55312-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC COCONUT OIL ACID DIETHANOLAMINE CONDENSATE Date: 01/28/99
Route: SKIN APPLICATION Time: 08:08:11
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 MG/KG 50 MG/KG 100
MG/KG
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (50) (50)
Accumulation, Hyaline Droplet 1 (2%) 1 (2%)
Cyst 8 (16%) 9 (18%) 7 (14%)
Hydronephrosis 1 (2%)
Mineralization 3 (6%) 3 (6%) 3 (6%)
Nephropathy, Chronic 49 (98%) 50 (100%) 49 (98%)
Pigmentation, Hemosiderin 43 (86%) 44 (88%) 50 (100%)
Renal Tubule, Hyperplasia 2 (4%)
Urinary Bladder (50) (50) (50)
Calculus Gross Observation 1 (2%)
Hemorrhage 1 (2%)
Inflammation, Chronic Active 2 (4%) 1 (2%)
Transitional Epithelium, Hyperplasia 1 (2%) 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
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