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National Toxicology Program. NTP Technical Report on the Toxicology and Carcinogenesis Studies of Glycidamide (CASRN 5694-00-8) in F344/N Nctr Rats and B6C3F1/Nctr Mice (Drinking Water Studies): Technical Report 588 [Internet]. Research Triangle Park (NC): National Toxicology Program; 2014 Nov.
NTP Technical Report on the Toxicology and Carcinogenesis Studies of Glycidamide (CASRN 5694-00-8) in F344/N Nctr Rats and B6C3F1/Nctr Mice (Drinking Water Studies): Technical Report 588 [Internet].
Show detailsTable B-1Summary of the Incidence of Neoplasms in Female Rats in the Two-year Drinking Water Study of Glycidamidea
| 0 mM | 0.0875 mM | 0.175 mM | 0.35 mM | 0.70 mM | |
|---|---|---|---|---|---|
| Disposition Summary | |||||
| Animals initially in study | 48 | 48 | 48 | 48 | 48 |
| Early deaths | |||||
| Moribund sacrifice | 7 | 15 | 11 | 20 | 40 |
| Natural deaths | 2 | – | 4 | 3 | 3 |
| Survivors | |||||
| Moribund sacrifice | 3 | 6 | 5 | 8 | 3 |
| Natural deaths | 1 | 1 | 1 | – | – |
| Terminal sacrifice | 35 | 26 | 27 | 17 | 2 |
| Animals examined microscopically | 48 | 48 | 48 | 48 | 48 |
| Alimentary System | |||||
| Esophagus | (48) | (48) | (48) | (48) | (48) |
| Intestine large, cecum | (46) | (48) | (44) | (45) | (45) |
| Adenoma | 1 (2%) | – | – | – | – |
| Leukemia mononuclear | – | 1 (2%) | – | 1 (2%) | – |
| Lymphoma malignant | – | – | – | 1 (2%) | – |
| Intestine large, colon | (46) | (48) | (44) | (45) | (45) |
| Adenoma | – | – | 1 (2%) | – | – |
| Intestine large, rectum | (46) | (48) | (45) | (45) | (45) |
| Sarcoma, metastatic, clitoral gland | – | – | – | 1 (2%) | – |
| Schwannoma malignant | – | – | 1 (2%) | – | – |
| Intestine small, duodenum | (46) | (48) | (45) | (45) | (45) |
| Adenocarcinoma | – | 1 (2%) | – | – | – |
| Leiomyoma | – | 1 (2%) | 1 (2%) | – | – |
| Intestine small, ileum | (46) | (48) | (44) | (45) | (45) |
| Leukemia mononuclear | – | – | – | – | 2 (4%) |
| Intestine small, jejunum | (46) | (48) | (45) | (44) | (44) |
| Sarcoma, metastatic, uterus | – | 1 (2%) | – | – | – |
| Liver | (48) | (48) | (48) | (48) | (48) |
| Hepatocellular adenoma, multiple | 1 (2%) | – | – | – | – |
| Leukemia mononuclear | 14 (29%) | 11 (23%) | 21 (44%) | 19 (40%) | 27 (56%) |
| Mesentery | (4) | (4) | (1) | (9) | (5) |
| Leukemia mononuclear | – | – | – | 1 (11%) | 1 (20%) |
| Lymphoma malignant | – | – | – | 1 (11%) | – |
| Oral mucosa | (1) | (2) | (5) | (4) | (9) |
| Squamous cell carcinoma | – | – | – | 1 (25%) | 2 (22%) |
| Squamous cell papilloma | 1 (100%) | 1 (50%) | 2 (40%) | – | 4 (44%) |
| Pancreas | (48) | (48) | (48) | (48) | (48) |
| Leukemia mononuclear | 2 (4%) | 2 (4%) | 4 (8%) | 5 (10%) | 4 (8%) |
| Lymphoma malignant | – | – | – | 1 (2%) | – |
| Sarcoma, metastatic, uterus | – | 1 (2%) | – | – | – |
| Salivary glands | (48) | (48) | (48) | (48) | (48) |
| Leukemia mononuclear | 2 (4%) | 1 (2%) | 1 (2%) | 1 (2%) | 1 (2%) |
| Lymphoma malignant | – | – | – | 1 (2%) | – |
| Stomach, forestomach | (48) | (48) | (48) | (47) | (46) |
| Lymphoma malignant | – | – | – | 1 (2%) | – |
| Squamous cell papilloma | – | 1 (2%) | – | – | 3 (7%) |
| Stomach, glandular | (47) | (48) | (45) | (46) | (46) |
| Adenoma | – | – | – | – | 1 (2%) |
| Leukemia mononuclear | 1 (2%) | – | 1 (2%) | 1 (2%) | – |
| Lymphoma malignant | – | – | – | 1 (2%) | – |
| Tongue | (0) | (1) | (1) | (3) | (4) |
| Squamous cell carcinoma | – | – | – | – | 1 (25%) |
| Squamous cell papilloma | – | 1 (100%) | – | 1 (33%) | – |
| Cardiovascular System | |||||
| Blood Vessel | (48) | (48) | (48) | (48) | (48) |
| Leukemia mononuclear | 1 (2%) | 2 (4%) | 2 (4%) | 2 (4%) | 1 (2%) |
| Heart | (48) | (48) | (48) | (48) | (48) |
| Leukemia mononuclear | 5 (10%) | 4 (8%) | 8 (17%) | 8 (17%) | 10 (21%) |
| Schwannoma malignant | 2 (4%) | 1 (2%) | 4 (8%) | 2 (4%) | 1 (2%) |
| Endocrine System | |||||
| Adrenal cortex | (48) | (48) | (48) | (48) | (48) |
| Adenoma | – | – | 1 (2%) | – | – |
| Carcinoma | 1 (2%) | – | – | – | – |
| Leukemia mononuclear | 2 (4%) | 2 (4%) | 4 (8%) | 2 (4%) | 5 (10%) |
| Lymphoma malignant | – | – | – | 1 (2%) | – |
| Adrenal medulla | (47) | (48) | (47) | (47) | (48) |
| Leukemia mononuclear | 2 (4%) | 5 (10%) | 5 (11%) | 4 (9%) | 7 (15%) |
| Pheochromocytoma benign | 2 (4%) | 1 (2%) | 1 (2%) | 4 (9%) | 2 (4%) |
| Pheochromocytoma complex | – | – | – | – | 1 (2%) |
| Pheochromocytoma malignant | – | – | 1 (2%) | 1 (2%) | – |
| Bilateral, pheochromocytoma benign | 1 (2%) | – | – | – | – |
| Islets, pancreatic | (48) | (48) | (48) | (48) | (47) |
| Adenoma | – | 1 (2%) | – | – | – |
| Leukemia mononuclear | – | 1 (2%) | – | 1 (2%) | – |
| Lymphoma malignant | – | – | – | 1 (2%) | – |
| Parathyroid gland | (48) | (45) | (48) | (47) | (46) |
| Pituitary gland | (47) | (48) | (47) | (46) | (48) |
| Leukemia mononuclear | 1 (2%) | 2 (4%) | 2 (4%) | 4 (9%) | 5 (10%) |
| Pars distalis, adenoma | 32 (68%) | 36 (75%) | 32 (68%) | 27 (59%) | 24 (50%) |
| Pars distalis, carcinoma | 2 (4%) | 2 (4%) | 2 (4%) | – | – |
| Thyroid gland | (48) | (48) | (46) | (46) | (47) |
| Leukemia mononuclear | 1 (2%) | – | – | 2 (4%) | 1 (2%) |
| C-cell, adenoma | 1 (2%) | 3 (6%) | 6 (13%) | 4 (9%) | 2 (4%) |
| C-cell, adenoma, multiple | 1 (2%) | 1 (2%) | – | – | – |
| C-cell, carcinoma | 1 (2%) | – | – | – | 1 (2%) |
| Follicular cell, adenoma | – | 3 (6%) | 3 (7%) | 1 (2%) | 5 (11%) |
| Follicular cell, carcinoma | – | – | 2 (4%) | 3 (7%) | 2 (4%) |
| Follicular cell, carcinoma, multiple | – | – | – | – | 1 (2%) |
| General Body System | |||||
| Tissue NOS | (0) | (1) | (0) | (0) | (0) |
| Sarcoma, metastatic, uterus | – | 1 (100%) | – | – | – |
| Genital System | |||||
| Clitoral gland | (48) | (48) | (48) | (48) | (47) |
| Adenoma | 6 (13%) | 3 (6%) | 6 (13%) | 3 (6%) | 5 (11%) |
| Carcinoma | 4 (8%) | 6 (13%) | 7 (15%) | 11 (23%) | 13 (28%) |
| Leukemia mononuclear | 2 (4%) | 2 (4%) | – | 2 (4%) | 2 (4%) |
| Sarcoma, deep invasion | – | – | – | 1 (2%) | – |
| Squamous cell carcinoma | 2 (4%) | – | – | – | – |
| Squamous cell papilloma | – | – | – | 1 (2%) | 2 (4%) |
| Bilateral, carcinoma | – | – | – | – | 1 (2%) |
| Ovary | (48) | (48) | (48) | (48) | (48) |
| Granulosa cell tumor malignant | 1 (2%) | – | – | – | – |
| Leukemia mononuclear | 3 (6%) | 1 (2%) | 6 (13%) | 3 (6%) | 4 (8%) |
| Uterus | (48) | (48) | (48) | (48) | (48) |
| Adenoma | – | – | – | 1 (2%) | 1 (2%) |
| Deciduoma benign | 1 (2%) | – | – | – | – |
| Leukemia mononuclear | 2 (4%) | – | 1 (2%) | 3 (6%) | 2 (4%) |
| Lymphoma malignant | – | – | – | 1 (2%) | – |
| Polyp stromal | 9 (19%) | 10 (21%) | 12 (25%) | 13 (27%) | 10 (21%) |
| Polyp stromal, multiple | 1 (2%) | 1 (2%) | – | – | – |
| Sarcoma | – | 1 (2%) | – | 1 (2%) | – |
| Sarcoma stromal | 1 (2%) | – | 2 (4%) | 1 (2%) | 2 (4%) |
| Bilateral, polyp stromal | 1 (2%) | – | 1 (2%) | 1 (2%) | 1 (2%) |
| Vagina | (3) | (3) | (4) | (5) | (1) |
| Sarcoma, metastatic, clitoral gland | – | – | – | 1 (20%) | – |
| Sarcoma stromal | – | – | – | – | 1 (100%) |
| Hematopoietic System | |||||
| Bone marrow | (48) | (48) | (46) | (47) | (47) |
| Leukemia mononuclear | 5 (10%) | 7 (15%) | 10 (22%) | 11 (23%) | 11 (23%) |
| Lymph node | (5) | (9) | (15) | (12) | (18) |
| Leukemia mononuclear | – | – | – | – | 2 (11%) |
| Lymphoma malignant | – | – | – | 1 (8%) | – |
| Axillary, leukemia mononuclear | 1 (20%) | 1 (11%) | 1 (7%) | 3 (25%) | – |
| Brachial, leukemia mononuclear | – | 1 (11%) | – | – | – |
| Cervical, carcinoma, metastatic, thyroid gland | – | – | – | – | 1 (6%) |
| Cervical, leukemia mononuclear | 1 (20%) | 1 (11%) | – | – | 1 (6%) |
| Iliac, leukemia mononuclear | – | – | – | 1 (8%) | – |
| Inguinal, leukemia mononuclear | – | 1 (11%) | – | – | 1 (6%) |
| Lumbar, leukemia mononuclear | 2 (40%) | 3 (33%) | 2 (13%) | 6 (50%) | 3 (17%) |
| Mediastinal, leukemia mononuclear | 2 (40%) | 4 (44%) | 5 (33%) | 4 (33%) | 3 (17%) |
| Mediastinal, lymphoma malignant | – | – | – | 1 (8%) | – |
| Pancreatic, leukemia mononuclear | 2 (40%) | 5 (56%) | 6 (40%) | 5 (42%) | 6 (33%) |
| Pancreatic, lymphoma malignant | – | – | – | 1 (8%) | – |
| Renal, leukemia mononuclear | 2 (40%) | 2 (22%) | 5 (33%) | 3 (25%) | 2 (11%) |
| Lymph node, mandibular | (48) | (48) | (47) | (47) | (47) |
| Leukemia mononuclear | 5 (10%) | 6 (13%) | 10 (21%) | 12 (26%) | 15 (32%) |
| Lymphoma malignant | – | – | – | 1 (2%) | – |
| Osteosarcoma, metastatic, nose | – | – | – | 1 (2%) | – |
| Lymph node, mesenteric | (47) | (48) | (47) | (48) | (48) |
| Leukemia mononuclear | 6 (13%) | 7 (15%) | 12 (26%) | 14 (29%) | 17 (35%) |
| Lymphoma malignant | – | – | – | 1 (2%) | – |
| Sarcoma, metastatic, uterus | – | 1 (2%) | – | – | – |
| Spleen | (48) | (48) | (48) | (48) | (48) |
| Leukemia mononuclear | 14 (29%) | 11 (23%) | 21 (44%) | 19 (40%) | 27 (56%) |
| Lymphoma malignant | – | – | – | 1 (2%) | – |
| Osteosarcoma, metastatic, nose | – | – | – | 1 (2%) | – |
| Thymus | (45) | (47) | (45) | (45) | (44) |
| Leukemia mononuclear | 2 (4%) | 3 (6%) | 3 (7%) | 4 (9%) | 6 (14%) |
| Lymphoma malignant | – | – | – | 1 (2%) | – |
| Thymoma benign | – | – | 1 (2%) | – | – |
| Integumentary System | |||||
| Mammary gland | (48) | (48) | (48) | (48) | (48) |
| Adenocarcinoma | 1 (2%) | – | 2 (4%) | 2 (4%) | 2 (4%) |
| Adenoma | 2 (4%) | – | 1 (2%) | – | 3 (6%) |
| Adenoma, multiple | – | – | – | – | 1 (2%) |
| Fibroadenoma | 9 (19%) | 15 (31%) | 16 (33%) | 10 (21%) | 13 (27%) |
| Fibroadenoma, multiple | 7 (15%) | 11 (23%) | 19 (40%) | 23 (48%) | 23 (48%) |
| Leukemia mononuclear | – | 1 (2%) | – | – | – |
| Skin | (48) | (48) | (48) | (48) | (48) |
| Basal cell carcinoma | 1 (2%) | – | – | – | – |
| Squamous cell carcinoma | – | – | – | – | 1 (2%) |
| Subcutaneous tissue, fibroma | 1 (2%) | – | – | 1 (2%) | – |
| Subcutaneous tissue, lipoma | – | 2 (4%) | 1 (2%) | – | – |
| Musculoskeletal System | |||||
| Bone | (0) | (1) | (1) | (0) | (0) |
| Cranium, meningioma malignant, metastatic, brain, cerebrum | – | 1 (100%) | – | – | – |
| Bone, femur | (48) | (48) | (48) | (48) | (48) |
| Chondrosarcoma | – | 1 (2%) | – | – | – |
| Skeletal muscle | (48) | (48) | (48) | (48) | (48) |
| Rhabdomyosarcoma | – | 1 (2%) | – | – | – |
| Sarcoma, metastatic, clitoral gland | – | – | – | 1 (2%) | – |
| Nervous System | |||||
| Brain, brain stem | (48) | (48) | (47) | (48) | (48) |
| Carcinoma, metastatic, pituitary gland | 2 (4%) | 2 (4%) | 2 (4%) | – | – |
| Leukemia mononuclear | – | 1 (2%) | 3 (6%) | 3 (6%) | 4 (8%) |
| Brain, cerebellum | (48) | (48) | (47) | (48) | (48) |
| Astrocytoma malignant | – | – | – | 1 (2%) | – |
| Granular cell tumor benign | – | – | – | 1 (2%) | – |
| Histiocytic sarcoma | – | – | – | – | 1 (2%) |
| Leukemia mononuclear | 1 (2%) | – | 3 (6%) | 3 (6%) | 2 (4%) |
| Meningioma malignant, metastatic, brain, cerebrum | – | 1 (2%) | – | – | – |
| Brain, cerebrum | (48) | (48) | (48) | (48) | (48) |
| Astrocytoma malignant | – | – | – | – | 1 (2%) |
| Carcinoma, metastatic, pituitary gland | – | – | 1 (2%) | – | – |
| Glioma malignant | – | – | – | 1 (2%) | 1 (2%) |
| Leukemia mononuclear | – | – | 5 (10%) | 4 (8%) | 3 (6%) |
| Meningioma malignant | – | 1 (2%) | – | – | – |
| Peripheral nerve, sciatic | (48) | (48) | (48) | (48) | (48) |
| Leukemia mononuclear | – | – | 1 (2%) | 1 (2%) | – |
| Spinal cord, cervical | (48) | (48) | (48) | (48) | (48) |
| Leukemia mononuclear | – | – | 3 (6%) | 2 (4%) | 1 (2%) |
| Spinal cord, lumbar | (48) | (48) | (47) | (48) | (48) |
| Leukemia mononuclear | – | – | 1 (2%) | 2 (4%) | – |
| Spinal cord, thoracic | (48) | (48) | (47) | (48) | (48) |
| Leukemia mononuclear | – | 1 (2%) | – | 1 (2%) | 1 (2%) |
| Respiratory System | |||||
| Lung | (48) | (48) | (48) | (48) | (48) |
| Alveolar/bronchiolar adenoma | – | – | 1 (2%) | – | – |
| Carcinoma, metastatic, Zymbal’s gland | 1 (2%) | – | – | – | – |
| Leukemia mononuclear | 5 (10%) | 7 (15%) | 11 (23%) | 11 (23%) | 15 (31%) |
| Lymphoma malignant | – | – | – | 1 (2%) | – |
| Sarcoma, metastatic, uterus | – | 1 (2%) | – | – | – |
| Nose | (48) | (48) | (48) | (48) | (47) |
| Adenoma | – | – | – | – | 1 (2%) |
| Leukemia mononuclear | 1 (2%) | – | – | – | – |
| Osteosarcoma | – | – | – | 1 (2%) | – |
| Nasopharyngeal duct, squamous cell carcinoma | – | – | – | – | 1 (2%) |
| Trachea | (48) | (48) | (47) | (47) | (48) |
| Special Senses System | |||||
| Eye | (46) | (47) | (45) | (45) | (45) |
| Leukemia mononuclear | 1 (2%) | – | 1 (2%) | – | – |
| Harderian gland | (48) | (48) | (46) | (47) | (47) |
| Leukemia mononuclear | 1 (2%) | – | 1 (2%) | – | – |
| Zymbal’s gland | (1) | (0) | (0) | (0) | (2) |
| Carcinoma | 1 (100%) | – | – | – | 2 (100%) |
| Urinary System | |||||
| Kidney | (48) | (48) | (48) | (47) | (48) |
| Leukemia mononuclear | 3 (6%) | 2 (4%) | 5 (10%) | 4 (9%) | 6 (13%) |
| Lymphoma malignant | – | – | – | 1 (2%) | – |
| Urinary bladder | (48) | (48) | (48) | (47) | (47) |
| Leukemia mononuclear | – | 1 (2%) | – | 1 (2%) | 1 (2%) |
| Sarcoma stromal, metastatic, uterus | – | – | 1 (2%) | – | – |
| Transitional epithelium, papilloma | – | – | – | – | 1 (2%) |
| Systemic Lesions | |||||
| Multiple organs | (48)b | (48)b | (48)b | (48)b | (48)b |
| Histiocytic sarcoma | – | – | – | – | 1 (2%) |
| Leukemia mononuclear | 14 (29%) | 11 (23%) | 21 (44%) | 19 (40%) | 27 (56%) |
| Lymphoma malignant | – | – | – | 1 (2%) | – |
| Neoplasm Summary | |||||
| Total animals with primary neoplasmsc | 45 | 48 | 46 | 46 | 48 |
| Total primary neoplasms | 108 | 116 | 147 | 137 | 164 |
| Total animals with benign neoplasms | 40 | 47 | 42 | 40 | 44 |
| Total benign neoplasms | 77 | 91 | 105 | 91 | 102 |
| Total animals with malignant neoplasms | 22 | 20 | 31 | 34 | 44 |
| Total malignant neoplasms | 31 | 25 | 42 | 46 | 62 |
| Total animals with metastatic neoplasms | 2 | 4 | 3 | 2 | 1 |
| Total metastatic neoplasms | 3 | 9 | 4 | 5 | 1 |
- a
Number of animals examined microscopically at the site and the number of animals with neoplasm.
- b
Number of animals with any tissue examined microscopically.
- c
Primary neoplasms: all neoplasms except metastatic neoplasms.
Table B-2Statistical Analysis of Neoplasms in Female Rats in the Two-year Drinking Water Study of Glycidamide
| 0 mM | 0.0875 mM | 0.175 mM | 0.35 mM | 0.70 mM | |
|---|---|---|---|---|---|
| Adrenal Medulla: Benign Pheochromocytoma | |||||
| Overall ratea | 3/47 (6%) | 1/48 (2%) | 1/47 (2%) | 4/47 (9%) | 2/48 (4%) |
| Adjusted rateb | 7.2% | 2.5% | 2.6% | 11.4% | 8.0% |
| Terminal ratec | 3/34 (9%) | 1/26 (4%) | 1/26 (4%) | 2/17 (12%) | 1/2 (50%) |
| First incidence (days)d | 736 (T) | 737 (T) | 736 (T) | 717 | 506 |
| Poly-3 teste | P = 0.245 | P = 0.320N | P = 0.330N | P = 0.405 | P = 0.627 |
| Brain (Cerebellum): Malignant Astrocytoma | |||||
| Overall rate | 0/48 (0%) | 0/48 (0%) | 0/47 (0%) | 1/48 (2%) | 0/48 (0%) |
| Adjusted rate | 0.0% | 0.0% | 0.0% | 2.8% | 0.0% |
| Terminal rate | 0/35 (0%) | 0/26 (0%) | 0/27 (0%) | 1/17 (6%) | 0/2 (0%) |
| First incidence (days) | – | – | – | 737 (T) | – |
| Poly-3 test | P = 0.363 | – | – | P = 0.461 | – |
| Brain (Cerebrum): Malignant Astrocytoma | |||||
| Overall rate | 0/48 (0%) | 0/48 (0%) | 0/48 (0%) | 0/48 (0%) | 1/48 (2%) |
| Adjusted rate | 0.0% | 0.0% | 0.0% | 0.0% | 4.0% |
| Terminal rate | 0/35 (0%) | 0/26 (0%) | 0/27 (0%) | 0/17 (0%) | 0/2 (0%) |
| First incidence (days) | – | – | – | – | 520 |
| Poly-3 test | P = 0.106 | – | – | – | P = 0.397 |
| Clitoral Gland: Adenoma | |||||
| Overall rate | 6/48 (13%) | 3/48 (6%) | 6/48 (13%) | 3/48 (6%) | 5/47 (11%) |
| Adjusted rate | 13.9% | 7.5% | 14.9% | 8.4% | 19.2% |
| Terminal rate | 5/35 (14%) | 3/26 (12%) | 6/27 (22%) | 1/17 (6%) | 0/2 (0%) |
| First incidence (days) | 665 | 736 (T) | 736 (T) | 697 | 465 |
| Poly-3 test | P = 0.340 | P = 0.278N | P = 0.570 | P = 0.346N | P = 0.409 |
| Clitoral Gland: Carcinoma | |||||
| Overall rate | 4/48 (8%) | 6/48 (13%) | 7/48 (15%) | 11/48 (23%) | 14/47 (30%) |
| Adjusted rate | 9.3% | 14.5% | 17.1% | 30.0% | 45.5% |
| Terminal rate | 4/35 (11%) | 3/26 (12%) | 5/27 (19%) | 6/17 (35%) | 1/2 (50%) |
| First incidence (days) | 736 (T) | 570 | 513 | 480 | 374 |
| Poly-3 test | P < 0.001*** | P = 0.345 | P = 0.233 | P = 0.017* | P < 0.001*** |
| Clitoral Gland: Squamous Cell Carcinoma | |||||
| Overall rate | 2/48 (4%) | 0/48 (0%) | 0/48 (0%) | 0/48 (0%) | 0/47 (0%) |
| Adjusted rate | 4.7% | 0.0% | 0.0% | 0.0% | 0.0% |
| Terminal rate | 2/35 (6%) | 0/26 (0%) | 0/27 (0%) | 0/17 (0%) | 0/2 (0%) |
| First incidence (days) | 737 (T) | – | – | – | – |
| Poly-3 test | P = 0.111N | P = 0.252N | P = 0.252N | P = 0.283N | P = 0.387N |
| Clitoral Gland: Squamous Cell Papilloma | |||||
| Overall rate | 0/48 (0%) | 0/48 (0%) | 0/48 (0%) | 1/48 (2%) | 2/47 (4%) |
| Adjusted rate | 0.0% | 0.0% | 0.0% | 2.8% | 8.3% |
| Terminal rate | 0/35 (0%) | 0/26 (0%) | 0/27 (0%) | 1/17 (6%) | 1/2 (50%) |
| First incidence (days) | – | – | – | 736 (T) | 620 |
| Poly-3 test | P = 0.013* | – | – | P = 0.461 | P = 0.136 |
| Clitoral Gland: Adenoma, Carcinoma, and Squamous Cell Carcinoma and Papilloma (Combined) | |||||
| Overall rate | 11/48 (23%) | 9/48 (19%) | 13/48 (27%) | 14/48 (29%) | 20/47 (43%) |
| Adjusted rate | 25.5% | 21.8% | 31.7% | 38.0% | 60.3% |
| Terminal rate | 10/35 (29%) | 6/26 (23%) | 11/27 (41%) | 8/17 (47%) | 2/2 (100%) |
| First incidence (days) | 665 | 570 | 513 | 480 | 374 |
| Poly-3 test | P < 0.001*** | P = 0.442N | P = 0.347 | P = 0.165 | P = 0.001** |
| Heart: Malignant Schwannoma | |||||
| Overall rate | 2/48 (4%) | 1/48 (2%) | 4/48 (8%) | 2/48 (4%) | 1/48 (2%) |
| Adjusted rate | 4.6% | 2.5% | 9.8% | 5.6% | 4.1% |
| Terminal rate | 1/35 (3%) | 1/26 (4%) | 2/27 (7%) | 1/17 (6%) | 0/2 (0%) |
| First incidence (days) | 665 | 736 (T) | 555 | 660 | 645 |
| Poly-3 test | P = 0.509 | P = 0.525N | P = 0.311 | P = 0.622 | P = 0.680N |
| Liver: Hepatocellular Adenoma | |||||
| Overall rate | 1/48 (2%) | 0/48 (0%) | 0/48 (0%) | 0/48 (0%) | 0/48 (0%) |
| Adjusted rate | 2.3% | 0.0% | 0.0% | 0.0% | 0.0% |
| Terminal rate | 1/35 (3%) | 0/26 (0%) | 0/27 (0%) | 0/17 (0%) | 0/2 (0%) |
| First incidence (days) | 736 (T) | – | – | – | – |
| Poly-3 test | P = 0.265N | P = 0.513N | P = 0.513N | P = 0.539N | P = 0.606N |
| Mammary Gland: Adenoma | |||||
| Overall rate | 2/48 (4%) | 0/48 (0%) | 1/48 (2%) | 0/48 (0%) | 4/48 (8%) |
| Adjusted rate | 4.6% | 0.0% | 2.5% | 0.0% | 15.7% |
| Terminal rate | 1/35 (3%) | 0/26 (0%) | 1/27 (4%) | 0/17 (0%) | 1/2 (50%) |
| First incidence (days) | 714 | – | 737 (T) | – | 550 |
| Poly-3 test | P = 0.050 | P = 0.252N | P = 0.524N | P = 0.284N | P = 0.144 |
| Mammary Gland: Adenocarcinoma | |||||
| Overall rate | 1/48 (2%) | 0/48 (0%) | 2/48 (4%) | 2/48 (4%) | 2/48 (4%) |
| Adjusted rate | 2.3% | 0.0% | 4.9% | 5.6% | 8.0% |
| Terminal rate | 0/35 (0%) | 0/26 (0%) | 1/27 (4%) | 1/17 (6%) | 0/2 (0%) |
| First incidence (days) | 579 | – | 555 | 522 | 550 |
| Poly-3 test | P = 0.102 | P = 0.516N | P = 0.478 | P = 0.435 | P = 0.324 |
| Mammary Gland: Fibroadenoma | |||||
| Overall rate | 16/48 (33%) | 26/48 (54%) | 35/48 (73%) | 33/48 (69%) | 36/48 (75%) |
| Adjusted rate | 35.9% | 59.4% | 81.4% | 85.4% | 90.7% |
| Terminal rate | 10/35 (29%) | 15/26 (58%) | 22/27 (82%) | 17/17 (100%) | 2/2 (100%) |
| First incidence (days) | 549 | 483 | 548 | 584 | 403 |
| Poly-3 test | P < 0.001*** | P = 0.019* | P < 0.001*** | P < 0.001*** | P < 0.001*** |
| Mammary Gland: Adenocarcinoma and Fibroadenoma (Combined) | |||||
| Overall rate | 17/48 (35%) | 26/48 (54%) | 36/48 (75%) | 34/48 (71%) | 36/48 (75%) |
| Adjusted rate | 37.7% | 59.4% | 82.7% | 86.5% | 90.7% |
| Terminal rate | 10/35 (29%) | 15/26 (58%) | 22/27 (82%) | 17/17 (100%) | 2/2 (100%) |
| First incidence (days) | 549 | 483 | 548 | 522 | 403 |
| Poly-3 test | P < 0.001*** | P = 0.029* | P < 0.001*** | P < 0.001*** | P < 0.001*** |
| Oral Mucosa: Squamous Cell Carcinoma | |||||
| Overall rate | 0/48 (0%) | 0/48 (0%) | 0/48 (0%) | 1/48 (2%) | 2/48 (4%) |
| Adjusted rate | 0.0% | 0.0% | 0.0% | 2.8% | 7.8% |
| Terminal rate | 0/35 (0%) | 0/26 (0%) | 0/27 (0%) | 1/17 (6%) | 0/2 (0%) |
| First incidence (days) | – | – | – | 737 (T) | 421 |
| Poly-3 test | P = 0.015* | – | – | P = 0.461 | P = 0.145 |
| Oral Mucosa: Squamous Cell Papilloma | |||||
| Overall rate | 1/48 (2%) | 1/48 (2%) | 2/48 (4%) | 0/48 (0%) | 4/48 (8%) |
| Adjusted rate | 2.3% | 2.5% | 5.0% | 0.0% | 15.3% |
| Terminal rate | 1/35 (3%) | 0/26 (0%) | 2/27 (7%) | 0/17 (0%) | 0/2 (0%) |
| First incidence (days) | 737 (T) | 670 | 736 (T) | – | 520 |
| Poly-3 test | P = 0.045* | P = 0.747 | P = 0.477 | P = 0.539N | P = 0.070 |
| Tongue: Squamous Cell Carcinoma | |||||
| Overall rate | 0/48 (0%) | 0/48 (0%) | 0/48 (0%) | 0/48 (0%) | 1/48 (2%) |
| Adjusted rate | 0.0% | 0.0% | 0.0% | 0.0% | 4.0% |
| Terminal rate | 0/35 (0%) | 0/26 (0%) | 0/27 (0%) | 0/17 (0%) | 0/2 (0%) |
| First incidence (days) | – | – | – | – | 574 |
| Poly-3 test | P = 0.105 | – | – | – | P = 0.397 |
| Tongue: Squamous Cell Papilloma | |||||
| Overall rate | 0/48 (0%) | 1/48 (2%) | 0/48 (0%) | 1/48 (2%) | 0/48 (0%) |
| Adjusted rate | 0.0% | 2.5% | 0.0% | 2.8% | 0.0% |
| Terminal rate | 0/35 (0%) | 0/26 (0%) | 0/27 (0%) | 0/17 (0%) | 0/2 (0%) |
| First incidence (days) | – | 693 | – | 584 | – |
| Poly-3 test | P = 0.548 | P = 0.488 | – | P = 0.464 | – |
| Oral Mucosa and Tongue (Combined): Squamous Cell Carcinoma and Papilloma (Combined) | |||||
| Overall rate | 1/48 (2%) | 2/48 (4%) | 2/48 (4%) | 2/48 (4%) | 7/48 (15%) |
| Adjusted rate | 2.3% | 4.9% | 5.0% | 5.6% | 25.0% |
| Terminal rate | 1/35 (3%) | 0/26 (0%) | 2/27 (7%) | 1/17 (6%) | 0/2 (0%) |
| First incidence (days) | 737 (T) | 670 | 736 (T) | 584 | 421 |
| Poly-3 test | P = 0.001** | P = 0.481 | P = 0.477 | P = 0.437 | P = 0.005** |
| Pituitary Gland (Pars Distalis): Adenoma | |||||
| Overall rate | 32/47 (68%) | 36/48 (75%) | 32/47 (68%) | 27/46 (59%) | 24/48 (50%) |
| Adjusted rate | 73.2% | 80.5% | 74.6% | 68.7% | 70.8% |
| Terminal rate | 26/34 (77%) | 20/26 (77%) | 21/27 (78%) | 11/17 (65%) | 2/2 (100%) |
| First incidence (days) | 572 | 519 | 513 | 435 | 374 |
| Poly-3 test | P = 0.243N | P = 0.277 | P = 0.540 | P = 0.414N | P = 0.509N |
| Stomach (Forestomach): Squamous Cell Papilloma | |||||
| Overall rate | 0/48 (0%) | 1/48 (2%) | 0/48 (0%) | 0/47 (0%) | 3/46 (7%) |
| Adjusted rate | 0.0% | 2.5% | 0.0% | 0.0% | 12.4% |
| Terminal rate | 0/35 (0%) | 1/26 (4%) | 0/27 (0%) | 0/17 (0%) | 0/2 (0%) |
| First incidence (days) | – | 736 (T) | – | – | 504 |
| Poly-3 test | P = 0.015* | P = 0.487 | – | – | P = 0.048* |
| Thyroid Gland: C-Cell Adenoma | |||||
| Overall rate | 2/48 (4%) | 4/48 (8%) | 6/46 (13%) | 4/46 (9%) | 2/47 (4%) |
| Adjusted rate | 4.7% | 9.8% | 15.3% | 11.4% | 8.1% |
| Terminal rate | 2/35 (6%) | 2/26 (8%) | 5/27 (19%) | 2/17 (12%) | 0/2 (0%) |
| First incidence (days) | 737 (T) | 610 | 682 | 670 | 571 |
| Poly-3 test | P = 0.358 | P = 0.313 | P = 0.104 | P = 0.249 | P = 0.485 |
| Thyroid Gland: C-Cell Carcinoma | |||||
| Overall rate | 1/48 (2%) | 0/48 (0%) | 0/46 (0%) | 0/46 (0%) | 1/47 (2%) |
| Adjusted rate | 2.3% | 0.0% | 0.0% | 0.0% | 4.1% |
| Terminal rate | 1/35 (3%) | 0/26 (0%) | 0/27 (0%) | 0/17 (0%) | 0/2 (0%) |
| First incidence (days) | 736 (T) | – | – | – | 705 |
| Poly-3 test | P = 0.447 | P = 0.513N | P = 0.519N | P = 0.542N | P = 0.618 |
| Thyroid Gland: Follicular Cell Adenoma | |||||
| Overall rate | 0/48 (0%) | 3/48 (6%) | 3/46 (7%) | 1/46 (2%) | 5/47 (11%) |
| Adjusted rate | 0.0% | 7.4% | 7.6% | 2.9% | 19.3% |
| Terminal rate | 0/35 (0%) | 1/26 (4%) | 2/27 (7%) | 0/17 (0%) | 1/2 (50%) |
| First incidence (days) | – | 652 | 555 | 716 | 465 |
| Poly-3 test | P = 0.017* | P = 0.109 | P = 0.104 | P = 0.459 | P = 0.007** |
| Thyroid Gland: Follicular Cell Carcinoma | |||||
| Overall rate | 0/48 (0%) | 0/48 (0%) | 2/46 (4%) | 3/46 (7%) | 3/47 (6%) |
| Adjusted rate | 0.0% | 0.0% | 5.1% | 8.6% | 12.0% |
| Terminal rate | 0/35 (0%) | 0/26 (0%) | 0/27 (0%) | 3/17 (18%) | 0/2 (0%) |
| First incidence (days) | – | – | 634 | 737 (T) | 596 |
| Poly-3 test | P = 0.006** | – | P = 0.219 | P = 0.085 | P = 0.051 |
| Thyroid Gland: Follicular Cell Adenoma and Carcinoma (Combined) | |||||
| Overall rate | 0/48 (0%) | 3/48 (6%) | 5/46 (11%) | 4/46 (9%) | 8/47 (17%) |
| Adjusted rate | 0.0% | 7.4% | 12.5% | 11.5% | 29.9% |
| Terminal rate | 0/35 (0%) | 1/26 (4%) | 2/27 (7%) | 3/17 (18%) | 1/2 (50%) |
| First incidence (days) | – | 652 | 555 | 716 | 465 |
| Poly-3 test | P < 0.001*** | P = 0.109 | P = 0.025* | P = 0.037* | P < 0.001*** |
| Uterus: Stromal Polyp | |||||
| Overall rate | 11/48 (23%) | 11/48 (23%) | 13/48 (27%) | 14/48 (29%) | 11/48 (23%) |
| Adjusted rate | 25.2% | 26.3% | 31.4% | 38.1% | 38.1% |
| Terminal rate | 9/35 (26%) | 7/26 (27%) | 8/27 (30%) | 8/17 (47%) | 0/2 (0%) |
| First incidence (days) | 572 | 570 | 513 | 584 | 453 |
| Poly-3 test | P = 0.086 | P = 0.550 | P = 0.345 | P = 0.155 | P = 0.184 |
| Uterus: Stromal Sarcoma | |||||
| Overall rate | 1/48 (2%) | 0/48 (0%) | 2/48 (4%) | 1/48 (2%) | 2/48 (4%) |
| Adjusted rate | 2.3% | 0.0% | 4.9% | 2.8% | 7.8% |
| Terminal rate | 0/35 (0%) | 0/26 (0%) | 1/27 (4%) | 0/17 (0%) | 0/2 (0%) |
| First incidence (days) | 721 | – | 619 | 364 | 453 |
| Poly-3 test | P = 0.152 | P = 0.514N | P = 0.480 | P = 0.721 | P = 0.332 |
| Zymbal’s Gland: Carcinoma | |||||
| Overall rate | 1/48 (2%) | 0/48 (0%) | 0/48 (0%) | 0/48 (0%) | 2/48 (4%) |
| Adjusted rate | 2.3% | 0.0% | 0.0% | 0.0% | 7.8% |
| Terminal rate | 0/35 (0%) | 0/26 (0%) | 0/27 (0%) | 0/17 (0%) | 0/2 (0%) |
| First incidence (days) | 686 | – | – | – | 343 |
| Poly-3 test | P = 0.134 | P = 0.514N | P = 0.514N | P = 0.540N | P = 0.332 |
| All Organs: Histiocytic Sarcoma | |||||
| Overall rate | 0/48 (0%) | 0/48 (0%) | 0/48 (0%) | 0/48 (0%) | 1/48 (2%) |
| Adjusted rate | 0.0% | 0.0% | 0.0% | 0.0% | 4.1% |
| Terminal rate | 0/35 (0%) | 0/26 (0%) | 0/27 (0%) | 0/17 (0%) | 0/2 (0%) |
| First incidence (days) | – | – | – | – | 704 |
| Poly-3 test | P = 0.105 | – | – | – | P = 0.394 |
| All Organs: Leukemia (Mononuclear) | |||||
| Overall rate | 14/48 (29%) | 11/48 (23%) | 21/48 (44%) | 19/48 (40%) | 27/48 (56%) |
| Adjusted rate | 30.6% | 25.5% | 47.4% | 47.9% | 72.6% |
| Terminal rate | 8/35 (23%) | 3/26 (12%) | 10/27 (37%) | 7/17 (42%) | 1/2 (50%) |
| First incidence (days) | 432 | 508 | 373 | 456 | 435 |
| Poly-3 test | P < 0.001*** | P = 0.382N | P = 0.076 | P = 0.076 | P < 0.001*** |
| All Organs: Malignant Lymphoma | |||||
| Overall rate | 0/48 (0%) | 0/48 (0%) | 0/48 (0%) | 1/48 (2%) | 0/48 (0%) |
| Adjusted rate | 0.0% | 0.0% | 0.0% | 2.8% | 0.0% |
| Terminal rate | 0/35 (0%) | 0/26 (0%) | 0/27 (0%) | 0/17 (0%) | 0/2 (0%) |
| First incidence (days) | – | – | – | 435 | – |
| Poly-3 test | P = 0.356 | – | – | P = 0.466 | – |
| All Organs: Osteosarcoma | |||||
| Overall rate | 0/48 (0%) | 0/48 (0%) | 0/48 (0%) | 1/48 (2%) | 0/48 (0%) |
| Adjusted rate | 0.0% | 0.0% | 0.0% | 2.8% | 0.0% |
| Terminal rate | 0/35 (0%) | 0/26 (0%) | 0/27 (0%) | 0/17 (0%) | 0/2 (0%) |
| First incidence (days) | – | – | – | 526 | – |
| Poly-3 test | P = 0.357 | – | – | P = 0.465 | – |
| All Organs: Osteosarcoma or Osteoma | |||||
| Overall rate | 0/48 (0%) | 0/48 (0%) | 0/48 (0%) | 1/48 (2%) | 0/48 (0%) |
| Adjusted rate | 0.0% | 0.0% | 0.0% | 2.8% | 0.0% |
| Terminal rate | 0/35 (0%) | 0/26 (0%) | 0/27 (0%) | 0/17 (0%) | 0/2 (0%) |
| First incidence (days) | – | – | – | 526 | – |
| Poly-3 test | P = 0.357 | – | – | P = 0.465 | – |
| All Organs: Benign Neoplasms | |||||
| Overall rate | 40/48 (83%) | 47/48 (98%) | 42/48 (88%) | 40/48 (83%) | 44/48 (92%) |
| Adjusted rate | 87.9% | 99.3% | 93.6% | 94.5% | 97.9% |
| Terminal rate | 32/35 (91%) | 26/26 (100%) | 26/27 (96%) | 17/17 (100%) | 2/2 (100%) |
| First incidence (days) | 549 | 483 | 513 | 435 | 374 |
| Poly-3 test | P = 0.089 | P = 0.018* | P = 0.260 | P = 0.201 | P = 0.048* |
| All Organs: Malignant Neoplasms | |||||
| Overall rate | 22/48 (46%) | 20/48 (42%) | 31/48 (65%) | 34/48 (71%) | 44/48 (92%) |
| Adjusted rate | 47.5% | 44.8% | 67.1% | 75.7% | 96.4% |
| Terminal rate | 14/35 (40%) | 9/26 (35%) | 16/27 (59%) | 11/17 (65%) | 2/2 (100%) |
| First incidence (days) | 432 | 483 | 373 | 364 | 343 |
| Poly-3 test | P < 0.001*** | P = 0.481N | P = 0.042* | P = 0.004** | P < 0.001*** |
| All Organs: Benign or Malignant Neoplasms | |||||
| Overall rate | 45/48 (94%) | 48/48 (100%) | 46/48 (96%) | 46/48 (96%) | 48/48 (100%) |
| Adjusted rate | 93.8% | 100.0% | 97.3% | 99.2% | 100.0% |
| Terminal rate | 32/35 (92%) | 26/26 (100%) | 26/27 (96%) | 17/17 (100%) | 2/2 (100%) |
| First incidence (days) | 432 | 483 | 373 | 364 | 343 |
| Poly-3 test | P = 0.083 | P = 0.119 | P = 0.364 | P = 0.180 | P = 0.119 |
- a
Number of animals with neoplasm per number of animals examined microscopically.
- b
Poly-3 estimated neoplasm incidence after adjustment for intercurrent mortality.
- c
Observed incidence at the terminal sacrifice.
- d
T indicates terminal sacrifice.
- e
Beneath the 0 mM Glycidamide are the p-values associated with the trend test. Beneath the treated (0.0875, 0.175, 0.35, and 0.70 mM Glycidamide) group incidences are the p-values corresponding to pairwise comparisons between the 0 mM Glycidamide group and the treated groups. The Poly-3 test accounts for differential mortality in animals that do not reach the terminal sacrifice. An N indicates a negative trend or decreased tumor incidence.
Table B-3Historical Incidence of Thyroid Gland Follicular Cell Neoplasms in NCTR Control Female F344/N Nctr Rats
| Study (Report Date) | Route of Administration | Incidence in Controls | ||
|---|---|---|---|---|
| Adenoma | Carcinoma | Adenoma or Carcinoma | ||
| Sulfamethazine (February 1988) | Diet | 5/170 (2.9%) | 0/170 (0.0%) | 5/170 (2.9%) |
| Gentian Violet (November 1988) | Diet | 1/159 (0.6%) | 0/159 (0.0%) | 1/159 (0.6%) |
| Doxylamine (April 1991) | Diet | 0/47 (0.0%) | 0/47 (0.0%) | 0/47 (0.0%) |
| Triprolidine (June 1991) | Diet | 1/45 (2.2%) | 0/45 (0.0%) | 1/45 (2.2%) |
| Pyrilamine (July 1991) | Diet | 0/48 (0.0%) | 0/48 (0.0%) | 0/48 (0.0%) |
| Fumonisin B1 (March 1999) | Diet | 0/48 (0.0%) | 0/48 (0.0%) | 0/48 (0.0%) |
| Malachite Green (June 2001) | Diet | 0/46 (0.0%) | 0/46 (0.0%) | 0/46 (0.0%) |
| Leucomalachite Green (June 2001) | Diet | 0/46 (0.0%) | 0/46 (0.0%) | 0/46 (0.0%) |
| Acrylamide (February 2012) | Drinking Water | 0/48 (0.0%) | 0/48 (0.0%) | 0/48 (0.0%) |
| Aloe vera Whole Leaf (2013) | Drinking Water | 0/48 (0.0%) | 0/48 (0.0%) | 0/48 (0.0%) |
| Total (%) (All studies) | 7/705 (0.1%) | 0/705 (0.0%) | 7/705 (0.1%) | |
| Range | 0.0–2.9% | 0.0% | 0.0–2.9% | |
| Total (%) (Drinking water studies) | 0/96 (0.0%) | 0/96 (0.0%) | 0/96 (0.0%) | |
| Range | 0.0% | 0.0% | 0.0% | |
Table B-4Historical Incidence of Carcinoma of the Clitoral Gland in NCTR Control Female F344/N Nctr Rats
| Study (Report Date) | Route of Administration | Incidence in Controls |
|---|---|---|
| Doxylamine (April 1991) | Diet | 3/46 (6.5%) |
| Triprolidine (June 1991) | Diet | 0/46 (0.0%) |
| Pyrilamine (July 1991) | Diet | 3/45 (6.7%) |
| Fumonisin B1 (March 1999) | Diet | 1/41 (2.4%) |
| Malachite Green (June 2001) | Diet | 5/48 (10.4%) |
| Leucomalachite Green (June 2001) | Diet | 2/47 (4.3%) |
| Acrylamide (February 2012) | Drinking Water | 1/48 (2.1%) |
| Aloe vera Whole Leaf (2013) | Drinking Water | 3/48 (6.3%) |
| Total (%) (All studies) | 18/369 (4.9%) | |
| Range | 0.0–10.4% | |
| Total (%) (Drinking water studies) | 4/96 (4.2%) | |
| Range | 2.1–6.3% |
Table B-5Historical Incidence of Fibroadenoma of the Mammary Gland in NCTR Control Female F344/N Nctr Rats
| Study (Report Date) | Route of Administration | Incidence in Controls |
|---|---|---|
| Sulfamethazine (February 1988) | Diet | 48/177 (27.1%) |
| Gentian Violet (November 1988) | Diet | 65/169 (38.5%) |
| Doxylamine (April 1991) | Diet | 19/48 (39.6%) |
| Triprolidine (June 1991) | Diet | 15/46 (32.6%) |
| Pyrilamine (July 1991) | Diet | 20/47 (42.6%) |
| Fumonisin B1 (March 1999) | Diet | 18/47 (38.3%) |
| Malachite Green (June 2001) | Diet | 15/46 (32.6%) |
| Leucomalachite Green (June 2001) | Diet | 20/48 (41.7%) |
| Acrylamide (February 2012) | Drinking Water | 16/48 (33.3%) |
| Aloe vera Whole Leaf (2013) | Drinking Water | 12/47 (25.5%) |
| Total (%) (All studies) | 248/723 (34.3%) | |
| Range | 25.5–42.6% | |
| Total (%) (Drinking water studies) | 28/95 (29.5%) | |
| Range | 25.5–33.3% |
Table B-6Historical Incidence of Neoplasms of the Oral Cavity in NCTR Control Female F344/N Nctr Rats
| Study (Report Date) | Route of Administration | Incidence in Controls | ||
|---|---|---|---|---|
| Papilloma or Squamous Cell Papilloma | Squamous Cell Carcinoma | Papilloma, Squamous Cell Papilloma, or Squamous Cell Carcinoma | ||
| Sulfamethazine (February 1988) | Diet | 0/179 (0.0%) | 0/179 (0.0%) | 0/179 (0.0%) |
| Gentian Violet (November 1988) | Diet | 1/167 (0.6%) | 0/167 (0.0%) | 1/167 (0.6%) |
| Doxylamine (April 1991) | Diet | –a | –a | –a |
| Triprolidine (June 1991) | Diet | – | – | – |
| Pyrilamine (July 1991) | Diet | 1/48 (2.1%) | 0/48 (0.0%) | 1/48 (2.1%) |
| Fumonisin B1 (March 1999) | Diet | 0/48 (0.0%) | 0/48 (0.0%) | 0/48 (0.0%) |
| Malachite Green (June 2001) | Diet | 0/48 (0.0%) | 0/48 (0.0%) | 0/48 (0.0%) |
| Leucomalachite Green (June 2001) | Diet | 0/48 (0.0%) | 0/48 (0.0%) | 0/48 (0.0%) |
| Acrylamide (February 2012) | Drinking Water | 0/48 (0.0%) | 0/48 (0.0%) | 0/48 (0.0%) |
| Aloe vera Whole Leaf (2013) | Drinking Water | 0/48 (0.0%) | 0/48 (0.0%) | 0/48 (0.0%) |
| Total (%) (All studies) | 2/634 (0.3%) | 0/634 (0.0%) | 2/634 (0.3%) | |
| Range | 0.0–2.1% | 0.0% | 0.0–2.1% | |
| Total (%) (Drinking water studies) | 0/96 (0.0%) | 0/96 (0.0%) | 0/96 (0.0%) | |
| Range | 0.0% | 0.0% | 0.0% | |
- a
Not reported.
Table B-7Historical Incidence of Squamous Cell Papilloma or Carcinoma (Combined) of the Forestomach in NCTR Control Female F344/N Nctr Rats
| Study (Report Date) | Route of Administration | Incidence in Controls |
|---|---|---|
| Sulfamethazine (February 1988) | Diet | 0/179 (0.0%) |
| Gentian Violet (November 1988) | Diet | 0/165 (0.0%) |
| Doxylamine (April 1991) | Diet | 0/47 (0.0%) |
| Triprolidine (June 1991) | Diet | 0/48 (0.0%) |
| Pyrilamine (July 1991) | Diet | 0/48 (0.0%) |
| Fumonisin B1 (March 1999) | Diet | 0/48 (0.0%) |
| Malachite Green (June 2001) | Diet | 0/48 (0.0%) |
| Leucomalachite Green (June 2001) | Diet | 0/48 (0.0%) |
| Acrylamide (February 2012) | Drinking Water | 0/48 (0.0%) |
| Aloe vera Whole Leaf (2013) | Drinking Water | 1/48 (2.1%) |
| Total (%) (All studies) | 1/727 (0.1%) | |
| Range | 0.0–2.1% | |
| Total (%) (Drinking water studies) | 1/96 (1.0%) | |
| Range | 0.0–2.1% |
Table B-8Historical Incidence of Mononuclear Cell Leukemia in NCTR Control Female F344/N Nctr Rats
| Study (Report Date) | Route of Administration | Incidence in Controls |
|---|---|---|
| Sulfamethazine (February 1988) | Diet | 67/179 (37.4%) |
| Gentian Violet (November 1988) | Diet | 77/171 (45.0%) |
| Doxylamine (April 1991) | Diet | 13/48 (27.1%) |
| Triprolidine (June 1991) | Diet | 12/48 (25.0%) |
| Pyrilamine (July 1991) | Diet | 6/48 (12.5%) |
| Fumonisin B1 (March 1999) | Diet | 13/48 (27.1%) |
| Malachite Green (June 2001) | Diet | 19/48 (39.6%) |
| Leucomalachite Green (June 2001) | Diet | 17/48 (35.4%) |
| Acrylamide (February 2012) | Drinking Water | 10/48 (20.8%) |
| Aloe vera Whole Leaf (2013) | Drinking Water | 10/48 (20.8%) |
| Total (%) (All studies) | 244/734 (33.2%) | |
| Range | 12.5–45.0% | |
| Total (%) (Drinking water studies) | 20/96 (20.8%) | |
| Range | 20.8% |
Table B-9Summary of the Incidence of Nonneoplastic Lesions in Female Rats in the Two-year Drinking Water Study of Glycidamidea
| 0 mM | 0.0875 mM | 0.175 mM | 0.35 mM | 0.70 mM | |
|---|---|---|---|---|---|
| Disposition Summary | |||||
| Animals initially in study | 48 | 48 | 48 | 48 | 48 |
| Early deaths | |||||
| Moribund sacrifice | 7 | 15 | 11 | 20 | 40 |
| Natural death | 2 | – | 4 | 3 | 3 |
| Survivors | |||||
| Moribund sacrifice | 3 | 6 | 5 | 8 | 3 |
| Natural death | 1 | 1 | 1 | – | – |
| Terminal sacrifice | 35 | 26 | 27 | 17 | 2 |
| Animals examined microscopically | 48 | 48 | 48 | 48 | 48 |
| Alimentary System | |||||
| Esophagus | (48) | (48) | (48) | (48) | (48) |
| Lumen, dilatation | – | – | – | 1 (2%) | – |
| Intestine large, cecum | (46) | (48) | (44) | (45) | (45) |
| Ulcer | 1 (2%) | – | – | – | – |
| Lumen, dilatation | – | 1 (2%) | – | – | 1 (2%) |
| Intestine large, colon | (46) | (48) | (44) | (45) | (45) |
| Goblet cell, hyperplasia | 1 (2%) | – | – | – | – |
| Intestine large, rectum | (46) | (48) | (45) | (45) | (45) |
| Intestine small, duodenum | (46) | (48) | (45) | (45) | (45) |
| Intestine small, ileum | (46) | (48) | (44) | (45) | (45) |
| Infiltration cellular, lymphocyte | 1 (2%) | – | – | – | – |
| Pigmentation | 1 (2%) | – | – | – | – |
| Intestine small, jejunum | (46) | (48) | (45) | (44) | (44) |
| Infiltration cellular, lymphocyte | – | – | – | – | 1 (2%) |
| Liver | (48) | (48) | (48) | (48) | (48) |
| Angiectasis | – | – | 1 (2%) | – | 1 (2%) |
| Basophilic focus | – | 2 (4%) | 2 (4%) | 2 (4%) | 4 (8%) |
| Basophilic focus, multiple | 41 (85%) | 38 (79%) | 36 (75%) | 35 (73%) | 32 (67%) |
| Clear cell focus | 2 (4%) | – | – | 1 (2%) | – |
| Congestion | 1 (2%) | 1 (2%) | – | – | – |
| Deformity | 7 (15%) | 4 (8%) | 4 (8%) | 5 (10%) | 7 (15%) |
| Degeneration, cystic | 3 (6%) | 2 (4%) | 3 (6%) | 2 (4%) | – |
| Eosinophilic focus | 5 (10%) | 8 (17%) | 5 (10%) | 4 (8%) | 4 (8%) |
| Eosinophilic focus, multiple | 2 (4%) | 3 (6%) | – | 4 (8%) | – |
| Granuloma | 3 (6%) | 3 (6%) | – | 1 (2%) | – |
| Hematopoietic cell proliferation | 1 (2%) | – | 1 (2%) | 1 (2%) | 2 (4%) |
| Hemorrhage | – | – | – | – | 1 (2%) |
| Hepatodiaphragmatic nodule | 2 (4%) | – | – | 2 (4%) | 1 (2%) |
| Hypertrophy | – | – | 1 (2%) | – | – |
| Infiltration cellular, lymphocyte | – | 1 (2%) | – | 2 (4%) | – |
| Inflammation, chronic active | 19 (40%) | 14 (29%) | 18 (38%) | 13 (27%) | 8 (17%) |
| Mitotic alteration | – | 1 (2%) | – | – | – |
| Mixed cell focus | 10 (21%) | 7 (15%) | 6 (13%) | 3 (6%) | 2 (4%) |
| Mixed cell focus, multiple | 8 (17%) | 8 (17%) | 6 (13%) | 5 (10%) | 3 (6%) |
| Necrosis | 2 (4%) | 8 (17%) | 1 (2%) | – | 3 (6%) |
| Pigmentation | 2 (4%) | 4 (8%) | 1 (2%) | – | 1 (2%) |
| Thrombosis | – | – | – | 2 (4%) | 1 (2%) |
| Vacuolization cytoplasmic | 15 (31%) | 11 (23%) | 18 (38%) | 12 (25%) | 7 (15%) |
| Bile duct, hyperplasia | 16 (33%) | 19 (40%) | 25 (52%) | 15 (31%) | 15 (31%) |
| Hepatocyte, degeneration | 4 (8%) | 6 (13%) | 3 (6%) | 3 (6%) | 4 (8%) |
| Hepatocyte, hyperplasia | – | 1 (2%) | 1 (2%) | 1 (2%) | 1 (2%) |
| Mesentery | (4) | (4) | (1) | (9) | (5) |
| Cyst | – | – | – | 1 (11%) | – |
| Infiltration cellular, lymphocyte | – | – | – | 1 (11%) | – |
| Fat, necrosis | 4 (100%) | 4 (100%) | 1 (100%) | 7 (78%) | 5 (100%) |
| Oral Mucosa | (1) | (2) | (5) | (4) | (9) |
| Epithelium, hyperplasia | – | 1 (50%) | 3 (60%) | 3 (75%) | 3 (33%) |
| Pancreas | (48) | (48) | (48) | (48) | (48) |
| Cyst | – | – | – | – | 1 (2%) |
| Necrosis | – | – | – | 2 (4%) | – |
| Acinus, degeneration | 21 (44%) | 18 (38%) | 17 (35%) | 19 (40%) | 13 (27%) |
| Salivary glands | (48) | (48) | (48) | (48) | (48) |
| Infiltration cellular, lymphocyte | 1 (2%) | – | – | – | – |
| Stomach, forestomach | (48) | (48) | (48) | (47) | (46) |
| Edema | – | – | – | – | 1 (2%) |
| Fibrosis | 1 (2%) | – | – | – | – |
| Inflammation, chronic active | 1 (2%) | 3 (6%) | 1 (2%) | 1 (2%) | 2 (4%) |
| Necrosis | – | – | 1 (2%) | – | 1 (2%) |
| Ulcer | – | 2 (4%) | 1 (2%) | 2 (4%) | – |
| Epithelium, hyperplasia | 3 (6%) | 3 (6%) | 2 (4%) | 2 (4%) | 6 (13%) |
| Stomach, glandular | (47) | (48) | (45) | (46) | (46) |
| Necrosis | 1 (2%) | 1 (2%) | – | – | 1 (2%) |
| Pigmentation | 1 (2%) | – | – | – | – |
| Epithelium, degeneration | – | – | – | – | 1 (2%) |
| Tongue | (0) | (1) | (1) | (3) | (4) |
| Inflammation, suppurative | – | – | – | 1 (33%) | – |
| Keratin cyst | – | – | – | 1 (33%) | – |
| Epithelium, hyperplasia | – | – | – | 1 (33%) | 1 (25%) |
| Cardiovascular System | |||||
| Blood vessel | (48) | (48) | (48) | (48) | (48) |
| Heart | (48) | (48) | (48) | (48) | (48) |
| Cardiomyopathy | 40 (83%) | 39 (81%) | 38 (79%) | 33 (69%) | 31 (65%) |
| Thrombosis | – | 3 (6%) | 2 (4%) | 1 (2%) | 1 (2%) |
| Endocardium, hyperplasia | – | 1 (2%) | – | – | – |
| Ventricle, dilatation | – | 1 (2%) | – | – | 1 (2%) |
| Endocrine System | |||||
| Adrenal cortex | (48) | (48) | (48) | (48) | (48) |
| Accessory adrenal cortical nodule | – | – | – | 3 (6%) | 1 (2%) |
| Angiectasis | 2 (4%) | 3 (6%) | 2 (4%) | 2 (4%) | – |
| Congestion | 1 (2%) | – | – | – | – |
| Cyst | – | – | 1 (2%) | – | – |
| Degeneration, cystic | 3 (6%) | 1 (2%) | 1 (2%) | 1 (2%) | 1 (2%) |
| Hemorrhage | 1 (2%) | – | – | – | – |
| Hyperplasia | 1 (2%) | 1 (2%) | – | 2 (4%) | 2 (4%) |
| Hypertrophy | 4 (8%) | – | 4 (8%) | – | – |
| Pigmentation | – | – | 1 (2%) | – | – |
| Vacuolization cytoplasmic | 12 (25%) | 13 (27%) | 12 (25%) | 17 (35%) | 22 (46%) |
| Adrenal medulla | (47) | (48) | (47) | (47) | (48) |
| Hyperplasia | 3 (6%) | 1 (2%) | 4 (9%) | 2 (4%) | – |
| Necrosis | – | – | – | – | 1 (2%) |
| Islets, pancreatic | (48) | (48) | (48) | (48) | (47) |
| Hyperplasia | – | 1 (2%) | – | 2 (4%) | – |
| Parathyroid gland | (48) | (45) | (48) | (47) | (46) |
| Hyperplasia | 2 (4%) | – | 2 (4%) | – | 3 (7%) |
| Pituitary gland | (47) | (48) | (47) | (46) | (48) |
| Pars distalis, angiectasis | – | – | – | – | 1 (2%) |
| Pars distalis, cyst | 3 (6%) | 3 (6%) | 1 (2%) | 1 (2%) | 5 (10%) |
| Pars distalis, hyperplasia | 11 (23%) | 7 (15%) | 12 (26%) | 14 (30%) | 20 (42%) |
| Pars intermedia, cyst | – | – | – | 1 (2%) | |
| Pars intermedia, hyperplasia | – | – | – | 1 (2%) | 1 (2%) |
| Pars intermedia, Rathke’s Cleft, Degeneration | – | – | – | 1 (2%) | – |
| Thyroid gland | (48) | (48) | (46) | (46) | (47) |
| Cyst | – | – | – | 1 (2%) | – |
| Infiltration cellular, polymorphonuclear | 1 (2%) | – | – | – | – |
| C-cell, hyperplasia | 31 (65%) | 27 (56%) | 24 (52%) | 16 (35%) | 19 (40%) |
| Follicular cell, hyperplasia | 1 (2%) | 1 (2%) | 1 (2%) | 1 (2%) | 1 (2%) |
| General Body System | |||||
| Tissue NOS | (0) | (1) | (0) | (0) | (0) |
| Genital System | |||||
| Clitoral gland | (48) | (48) | (48) | (48) | (47) |
| Fibrosis | – | – | – | 1 (2%) | – |
| Hyperkeratosis | – | – | – | – | 1 (2%) |
| Infiltration cellular, lymphocyte | 1 (2%) | – | 1 (2%) | 1 (2%) | 1 (2%) |
| Inflammation, suppurative | 16 (33%) | 13 (27%) | 17 (35%) | 20 (42%) | 13 (28%) |
| Inflammation, chronic | – | 1 (2%) | – | – | – |
| Inflammation, chronic active | 5 (10%) | 5 (10%) | 8 (17%) | – | 4 (9%) |
| Necrosis | – | 2 (4%) | – | – | – |
| Acinus, degeneration | 16 (33%) | 21 (44%) | 15 (31%) | 16 (33%) | 10 (21%) |
| Duct, ectasia | 25 (52%) | 21 (44%) | 25 (52%) | 17 (35%) | 19 (40%) |
| Epithelium, hyperplasia | 4 (8%) | 2 (4%) | 2 (4%) | 1 (2%) | 4 (9%) |
| Ovary | (48) | (48) | (48) | (48) | (48) |
| Atrophy | 44 (92%) | 46 (96%) | 44 (92%) | 46 (96%) | 47 (98%) |
| Cyst | 3 (6%) | 2 (4%) | 2 (4%) | 2 (4%) | 1 (2%) |
| Bilateral, cyst | – | – | – | 1 (2%) | – |
| Uterus | (48) | (48) | (48) | (48) | (48) |
| Angiectasis | – | – | 1 (2%) | – | – |
| Cyst | 2 (4%) | 4 (8%) | 5 (10%) | 5 (10%) | 4 (8%) |
| Decidual reaction | – | – | – | – | 1 (2%) |
| Hemorrhage | 1 (2%) | – | 1 (2%) | – | 1 (2%) |
| Cervix, fibrosis | – | 1 (2%) | – | 3 (6%) | 1 (2%) |
| Endometrium, hyperplasia, cystic | 11 (23%) | 17 (35%) | 14 (29%) | 14 (29%) | 23 (48%) |
| Lumen, dilatation | 6 (13%) | 3 (6%) | 6 (13%) | 3 (6%) | 3 (6%) |
| Vagina | (3) | (3) | (4) | (5) | (1) |
| Fibrosis | – | – | – | 1 (20%) | – |
| Inflammation, suppurative | – | 1 (33%) | – | – | – |
| Prolapse | – | – | 1 (25%) | – | 1 (100%) |
| Lumen, dilatation | 3 (100%) | 3 (100%) | 3 (75%) | 4 (80%) | – |
| Mucocyte, hyperplasia | 2 (67%) | – | – | – | – |
| Hematopoietic System | |||||
| Bone marrow | (48) | (48) | (46) | (47) | (47) |
| Atrophy | – | – | – | 1 (2%) | 1 (2%) |
| Hyperplasia | 2 (4%) | 6 (13%) | 7 (15%) | 8 (17%) | 14 (30%) |
| Lymph node | (5) | (9) | (15) | (12) | (18) |
| Lumbar, hyperplasia, lymphoid | – | 1 (11%) | 1 (7%) | 1 (8%) | 1 (6%) |
| Lumbar, infiltration cellular, plasma cell | – | – | 1 (7%) | 1 (8%) | 1 (6%) |
| Lumbar, sinus, dilatation | – | – | – | 1 (8%) | 2 (11%) |
| Mediastinal, fibrosis | – | 1 (11%) | – | – | – |
| Mediastinal, hemorrhage | – | 1 (11%) | 1 (7%) | – | – |
| Mediastinal, hyperplasia, lymphoid | – | – | 1 (7%) | – | 1 (6%) |
| Mediastinal, pigmentation | – | 1 (11%) | 1 (7%) | – | – |
| Mediastinal, sinus, dilatation | – | 1 (11%) | – | – | – |
| Pancreatic, hyperplasia, lymphoid | 1 (20%) | – | – | 1 (8%) | 1 (6%) |
| Pancreatic, infiltration cellular, histiocyte | – | – | 1 (7%) | 1 (8%) | – |
| Pancreatic, infiltration cellular, plasma cell | – | – | – | – | 1 (6%) |
| Pancreatic, sinus, dilatation | – | – | 2 (13%) | – | – |
| Renal, hemorrhage | 1 (20%) | – | – | – | – |
| Renal, hyperplasia, lymphoid | – | – | – | – | 2 (11%) |
| Renal, infiltration, cellular, histiocyte | – | – | 1 (7%) | 1 (8%) | 1 (6%) |
| Renal, infiltration, cellular, plasma cell | – | – | – | – | 1 (6%) |
| Renal, sinus, dilatation | 1 (20%) | – | 2 (13%) | – | – |
| Sinus, thoracic, dilatation | – | – | – | 1 (8%) | – |
| Thoracic, hemorrhage | – | – | – | 1 (8%) | – |
| Thoracic, infiltration cellular, histiocyte | – | – | – | 1 (8%) | – |
| Lymph node, mandibular | (48) | (48) | (47) | (47) | (47) |
| Hemorrhage | – | 1 (2%) | 1 (2%) | – | 2 (4%) |
| Hyperplasia, lymphoid | 6 (13%) | 4 (8%) | 7 (15%) | 4 (9%) | 9 (19%) |
| Infiltration cellular, plasma cell | 22 (46%) | 16 (33%) | 18 (38%) | 20 (43%) | 16 (34%) |
| Sinus, dilatation | 3 (6%) | 5 (10%) | 3 (6%) | 5 (11%) | 6 (13%) |
| Lymph node, mesenteric | (47) | (48) | (47) | (48) | (48) |
| Erythrophagocytosis | – | 1 (2%) | – | – | – |
| Hemorrhage | 1 (2%) | 2 (4%) | – | 4 (8%) | 2 (4%) |
| Hyperplasia, lymphoid | 10 (21%) | 6 (13%) | 6 (13%) | 5 (10%) | 10 (21%) |
| Infiltration cellular, histiocyte | – | – | – | – | 1 (2%) |
| Infiltration cellular, mast cell | – | – | 1 (2%) | 1 (2%) | – |
| Infiltration cellular, plasma cell | 2 (4%) | 4 (8%) | 6 (13%) | 4 (8%) | 6 (13%) |
| Sinus, dilatation | 2 (4%) | 2 (4%) | – | – | 1 (2%) |
| Spleen | (48) | (48) | (48) | (48) | (48) |
| Accessory spleen | – | 1 (2%) | – | 1 (2%) | – |
| Congestion | – | – | 1 (2%) | – | – |
| Depletion lymphoid | – | – | – | – | 1 (2%) |
| Fibrosis | 1 (2%) | 3 (6%) | 3 (6%) | 5 (10%) | 5 (10%) |
| Hematopoietic cell proliferation | 14 (29%) | 15 (31%) | 9 (19%) | 16 (33%) | 11 (23%) |
| Hemorrhage | 1 (2%) | – | 1 (2%) | 2 (4%) | – |
| Hyperplasia, lymphoid | 1 (2%) | 3 (6%) | – | 2 (4%) | – |
| Hyperplasia, stromal | – | – | 1 (2%) | – | – |
| Necrosis | 1 (2%) | – | 1 (2%) | 1 (2%) | 2 (4%) |
| Pigmentation | 36 (75%) | 34 (71%) | 20 (42%) | 21 (44%) | 14 (29%) |
| Thymus | (45) | (47) | (45) | (45) | (44) |
| Atrophy | 43 (96%) | 44 (94%) | 41 (91%) | 40 (89%) | 40 (91%) |
| Cyst | – | – | – | – | 1 (2%) |
| Cyst, multilocular | – | – | 1 (2%) | – | – |
| Integumentary System | |||||
| Mammary gland | (48) | (48) | (48) | (48) | (48) |
| Abscess | – | 1 (2%) | – | – | – |
| Galactocele | 7 (15%) | 8 (17%) | 12 (25%) | 9 (19%) | 3 (6%) |
| Inflammation, chronic active | – | 1 (2%) | – | – | – |
| Lactation | 11 (23%) | 10 (21%) | 3 (6%) | 2 (4%) | 2 (4%) |
| Alveolus, hyperplasia | 10 (21%) | 6 (13%) | 2 (4%) | 1 (2%) | 1 (2%) |
| Skin | (48) | (48) | (48) | (48) | (48) |
| Abscess | – | 1 (2%) | – | – | – |
| Cyst epithelial inclusion | 1 (2%) | – | 2 (4%) | – | 2 (4%) |
| Hemorrhage | – | – | – | 1 (2%) | – |
| Infiltration cellular, plasma cell | – | 1 (2%) | – | – | – |
| Inflammation, suppurative | 3 (6%) | 3 (6%) | – | 3 (6%) | 2 (4%) |
| Inflammation, chronic active | – | 1 (2%) | – | 2 (4%) | – |
| Ulcer | 3 (6%) | 2 (4%) | 1 (2%) | 4 (8%) | 1 (2%) |
| Epithelium, hyperplasia | 3 (6%) | 2 (4%) | – | 2 (4%) | 1 (2%) |
| Musculoskeletal System | |||||
| Bone | (0) | (1) | (1) | (0) | (0) |
| Bone, femur | (48) | (48) | (48) | (48) | (48) |
| Fibrous osteodystrophy | – | 3 (6%) | – | – | – |
| Osteopetrosis | – | – | – | 3 (6%) | – |
| Skeletal muscle | (48) | (48) | (48) | (48) | (48) |
| Nervous System | |||||
| Brain, brain stem | (48) | (48) | (47) | (48) | (48) |
| Compression | 10 (21%) | 10 (21%) | 12 (26%) | 6 (13%) | 11 (23%) |
| Hemorrhage | 2 (4%) | 1 (2%) | 3 (6%) | – | – |
| Brain, cerebellum | (48) | (48) | (47) | (48) | (48) |
| Gliosis | – | – | 1 (2%) | 2 (4%) | 1 (2%) |
| Hemorrhage | 1 (2%) | 1 (2%) | 1 (2%) | 1 (2%) | 1 (2%) |
| Ventricle, dilatation | 1 (2%) | – | – | – | – |
| Brain, cerebrum | (48) | (48) | (48) | (48) | (48) |
| Cyst | – | – | – | 1 (2%) | – |
| Gliosis | – | – | 3 (6%) | 2 (4%) | 3 (6%) |
| Hemorrhage | 1 (2%) | 1 (2%) | 3 (6%) | 1 (2%) | 1 (2%) |
| Necrosis | – | – | – | – | 1 (2%) |
| Ventricle, dilatation | 4 (8%) | 2 (4%) | 2 (4%) | – | – |
| Ventricle, hemorrhage | – | – | 1 (2%) | – | – |
| Peripheral nerve, sciatic | (48) | (48) | (48) | (48) | (48) |
| Axon, degeneration | 27 (56%) | 24 (50%) | 32 (67%) | 32 (67%) | 20 (42%) |
| Spinal cord, cervical | (48) | (48) | (48) | (48) | (48) |
| Gliosis | – | – | – | 1 (2%) | – |
| Hemorrhage | 1 (2%) | – | – | – | – |
| Inflammation, chronic active | 1 (2%) | – | – | – | – |
| Axon, degeneration | 32 (67%) | 19 (40%) | 25 (52%) | 14 (29%) | 14 (29%) |
| Nerve, degeneration | 2 (4%) | 3 (6%) | 3 (6%) | 1 (2%) | – |
| Spinal cord, lumbar | (48) | (48) | (47) | (48) | (48) |
| Gliosis | – | – | 2 (4%) | – | 1 (2%) |
| Axon, degeneration | 5 (10%) | 6 (13%) | 5 (11%) | 6 (13%) | 9 (19%) |
| Meninges, hyperplasia | – | – | – | 1 (2%) | – |
| Meninges, infiltration cellular, histiocyte | – | – | 1 (2%) | – | – |
| Nerve, degeneration | 35 (73%) | 35 (73%) | 35 (74%) | 30 (63%) | 23 (48%) |
| Nerve, gliosis | 1 (2%) | – | – | – | – |
| Nerve, hyperplasia | – | 1 (2%) | – | – | – |
| Neuron, degeneration | – | – | – | – | 1 (2%) |
| Spinal cord, thoracic | (48) | (48) | (47) | (48) | (48) |
| Hemorrhage | – | – | 1 (2%) | – | – |
| Mineralization | – | 1 (2%) | – | – | – |
| Axon, degeneration | 29 (60%) | 26 (54%) | 18 (38%) | 17 (35%) | 18 (38%) |
| Meninges, hyperplasia | – | – | 1 (2%) | 1 (2%) | – |
| Meninges, infiltration cellular, histiocyte | – | – | – | 1 (2%) | – |
| Nerve, degeneration | 8 (17%) | 7 (15%) | 8 (17%) | 8 (17%) | 2 (4%) |
| Respiratory System | |||||
| Lung | (48) | (48) | (48) | (48) | (48) |
| Congestion | – | – | – | – | 2 (4%) |
| Fibrosis | – | 1 (2%) | – | – | – |
| Hemorrhage | 1 (2%) | – | – | – | – |
| Infiltration cellular, histiocyte | 24 (50%) | 25 (52%) | 24 (50%) | 20 (42%) | 9 (19%) |
| Inflammation, chronic active | – | – | 1 (2%) | – | – |
| Necrosis | – | – | – | – | 1 (2%) |
| Pigmentation | – | 1 (2%) | – | – | – |
| Polyarteritis | – | – | – | – | 1 (2%) |
| Alveolar epithelium, hyperplasia | 3 (6%) | 1 (2%) | 3 (6%) | 1 (2%) | 4 (8%) |
| Nose | (48) | (48) | (48) | (48) | (47) |
| Foreign body | – | – | – | 1 (2%) | – |
| Hyaline droplet | 5 (10%) | 6 (13%) | 2 (4%) | 5 (10%) | 2 (4%) |
| Inflammation, suppurative | 1 (2%) | 1 (2%) | 2 (4%) | 4 (8%) | 1 (2%) |
| Inflammation, chronic active | 2 (4%) | – | – | 1 (2%) | 1 (2%) |
| Goblet cell, hyperplasia | 1 (2%) | 1 (2%) | 2 (4%) | 3 (6%) | 2 (4%) |
| Trachea | (48) | (48) | (47) | (47) | (48) |
| Inflammation, suppurative | 1 (2%) | – | – | – | – |
| Necrosis | 1 (2%) | – | – | – | – |
| Ulcer | 1 (2%) | – | – | – | – |
| Special Senses System | |||||
| Eye | (46) | (47) | (45) | (45) | (45) |
| Cataract | – | – | – | 1 (2%) | 2 (4%) |
| Inflammation, suppurative | 1 (2%) | – | – | – | – |
| Bilateral, cataract | – | – | 1 (2%) | – | – |
| Bilateral, retina, degeneration | 5 (11%) | 4 (9%) | 3 (7%) | 2 (4%) | 2 (4%) |
| Retina, degeneration | 7 (15%) | 7 (15%) | 6 (13%) | 6 (13%) | 4 (9%) |
| Harderian gland | (48) | (48) | (46) | (47) | (47) |
| Infiltration cellular, lymphocyte | 8 (17%) | 5 (10%) | 1 (2%) | 2 (4%) | 8 (17%) |
| Inflammation, chronic | 1 (2%) | – | – | – | – |
| Inflammation, chronic active | – | – | – | 1 (2%) | – |
| Pigmentation | – | – | 1 (2%) | – | – |
| Acinus, degeneration | – | – | 1 (2%) | – | – |
| Epithelium, hyperplasia | – | – | – | 1 (2%) | – |
| Zymbal’s gland | (1) | (0) | (0) | (0) | (2) |
| Urinary System | |||||
| Kidney | (48) | (48) | (48) | (47) | (48) |
| Cyst | – | – | – | 1 (2%) | – |
| Hyaline droplet | 1 (2%) | 2 (4%) | 2 (4%) | 1 (2%) | 2 (4%) |
| Infarct | – | – | – | 1 (2%) | – |
| Mineralization | 34 (71%) | 33 (69%) | 29 (60%) | 36 (77%) | 30 (63%) |
| Nephropathy | 43 (90%) | 39 (81%) | 38 (79%) | 32 (68%) | 25 (52%) |
| Pigmentation | – | – | – | 1 (2%) | 3 (6%) |
| Urinary Bladder | (48) | (48) | (48) | (47) | (47) |
| Infiltration cellular, histiocyte | – | – | – | – | 1 (2%) |
| Lumen, dilatation | – | – | 2 (4%) | – | 1 (2%) |
- a
Number of animals examined microscopically at the site and the number of animals with lesion.
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- unnamed protein product [Homo sapiens]unnamed protein product [Homo sapiens]gi|158254428|dbj|BAF83187.1|Protein
- Homo sapiens armadillo like helical domain containing 4 (ARMH4), transcript vari...Homo sapiens armadillo like helical domain containing 4 (ARMH4), transcript variant 1, mRNAgi|1653962446|ref|NM_001001872.4|Nucleotide
- Starmerella sp. ST12.14/027 26S ribosomal RNA gene, partial sequenceStarmerella sp. ST12.14/027 26S ribosomal RNA gene, partial sequencegi|854929355|gb|KP405917.1|Nucleotide
- Apostasia nuda xanthine dehydrogenase (Xdh) gene, partial cdsApostasia nuda xanthine dehydrogenase (Xdh) gene, partial cdsgi|311702859|gb|GU004525.1|Nucleotide
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