TDMS Study 05040-01 Pathology Tables
INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) HYDROQUINONE NTP Experiment-Test: 05040-01 Report: PEIRPT05 Study Type: CHRONIC Date: 09/05/94 Route: GAVAGE Time: 10:19:35 Facility: American Biogenics Corp. Chemical CAS #: 000123319 Lock Date: None 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: 05040-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC HYDROQUINONE Date: 09/05/94 Route: GAVAGE Time: 10:19:35 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE VEHICLE 25 MG/KG 50 MG/KG CONTROL ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially in Study 65 65 65 Scheduled Sacrifice 10 10 10 Early Deaths Moribund 14 19 14 Dead 1 6 6 Gavage Death 3 3 Survivors Terminal Sacrifice 39 27 31 Dead 1 Accident 1 Animals Examined Microscopically 55 55 55 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Cecum (53) (24) (53) Intestine Large, Colon (55) (26) (54) Intestine Large, Rectum (55) (28) (51) Intestine Small, Duodenum (55) (28) (55) Intestine Small, Ileum (54) (24) (53) Sarcoma 1 (2%) Intestine Small, Jejunum (54) (23) (51) Cystadenocarcinoma 1 (2%) Sarcoma 1 (2%) Liver (55) (55) (55) Mesentery (7) (13) (16) Pheochromocytoma Malignant, Extension, Metastatic, Adrenal Gland 1 (6%) Pancreas (55) (28) (55) Salivary Glands (55) (26) (55) Stomach, Forestomach (55) (28) (54) Stomach, Glandular (55) (28) (54) Tongue (1) Squamous Cell Papilloma 1 (100%) Tooth (3) (3) (5) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (55) (28) (55) ____________________________________________________________________________________________________________________________________ Page 2 NTP Experiment-Test: 05040-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC HYDROQUINONE Date: 09/05/94 Route: GAVAGE Time: 10:19:35 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE VEHICLE 25 MG/KG 50 MG/KG CONTROL ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Gland, Cortex (55) (55) (55) Adenoma 1 (2%) Adrenal Gland, Medulla (54) (55) (54) Pheochromocytoma Malignant 1 (2%) 1 (2%) 1 (2%) Pheochromocytoma Complex 1 (2%) Pheochromocytoma Benign 2 (4%) 4 (7%) Bilateral, Pheochromocytoma Benign 1 (2%) Islets, Pancreatic (53) (28) (55) Parathyroid Gland (54) (22) (54) Pituitary Gland (54) (54) (54) Meningioma Malignant, Metastatic 1 (2%) Pars Distalis, Adenoma 23 (43%) 21 (39%) 16 (30%) Pars Distalis, Carcinoma 1 (2%) 1 (2%) Thyroid Gland (55) (54) (55) Bilateral, C-Cell, Adenoma 1 (2%) C-Cell, Adenoma 8 (15%) 3 (6%) 5 (9%) C-Cell, Carcinoma 4 (7%) 1 (2%) 3 (5%) Follicular Cell, Adenocarcinoma 1 (2%) 1 (2%) Follicular Cell, Adenoma 1 (2%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Clitoral Gland (51) (24) (52) Adenoma 4 (8%) 3 (13%) 9 (17%) Ovary (55) (29) (55) Granulosa Cell Tumor Malignant 1 (2%) 1 (3%) Luteoma 1 (3%) Oviduct (2) Uterus (55) (55) (55) Leiomyosarcoma 1 (2%) Polyp Stromal 12 (22%) 5 (9%) 9 (16%) Bilateral, Polyp Stromal 1 (2%) Endometrium, Adenocarcinoma 1 (2%) Endometrium, Sarcoma Stromal 1 (2%) 1 (2%) Vagina (2) (1) (1) Squamous Cell Carcinoma 1 (100%) ____________________________________________________________________________________________________________________________________ Page 3 NTP Experiment-Test: 05040-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC HYDROQUINONE Date: 09/05/94 Route: GAVAGE Time: 10:19:35 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE VEHICLE 25 MG/KG 50 MG/KG CONTROL ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Blood (8) (10) (18) Bone Marrow (55) (28) (55) Lymph Node (55) (28) (55) Lymph Node, Mandibular (55) (26) (52) Lymph Node, Mesenteric (53) (28) (54) Spleen (55) (55) (55) Thymus (52) (27) (51) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (55) (55) (54) Adenocarcinoma 2 (4%) 1 (2%) Adenocarcinoma, Multiple 1 (2%) Adenoma 2 (4%) Fibroadenoma 28 (51%) 22 (40%) 21 (39%) Fibroadenoma, Multiple 1 (2%) 1 (2%) Skin (55) (30) (55) Basal Cell Adenoma 1 (3%) Keratoacanthoma 1 (3%) 2 (4%) Squamous Cell Papilloma 1 (2%) Subcutaneous Tissue, Sarcoma 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (54) (28) (55) Cartilage, Adenocarcinoma, Extension, Metastatic, Thyroid Gland 1 (4%) Skeletal Muscle (1) (2) (2) Pheochromocytoma Malignant, Extension, Metastatic, Adrenal Gland 1 (50%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (55) (28) (55) Astrocytoma Malignant 1 (4%) Meninges, Meningioma Malignant 1 (2%) Pons, Carcinoma, Metastatic 1 (2%) Spinal Cord (8) (7) (12) ____________________________________________________________________________________________________________________________________ Page 4 NTP Experiment-Test: 05040-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC HYDROQUINONE Date: 09/05/94 Route: GAVAGE Time: 10:19:35 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE VEHICLE 25 MG/KG 50 MG/KG CONTROL ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (55) (29) (55) Alveolar/Bronchiolar Carcinoma 1 (3%) 1 (2%) Carcinoma, Metastatic, Thyroid Gland 1 (2%) Pheochromocytoma Malignant, Metastatic, Adrenal Gland 1 (2%) Nose (55) (28) (55) Trachea (55) (28) (55) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Zymbal's Gland (1) Carcinoma 1 (100%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (55) (55) (55) Urinary Bladder (55) (27) (51) ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS Multiple Organs *(55) *(55) *(55) Leukemia Mononuclear 9 (16%) 15 (27%) 22 (40%) ____________________________________________________________________________________________________________________________________ * Number of animals with any tissue examined microscopically Page 5 NTP Experiment-Test: 05040-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC HYDROQUINONE Date: 09/05/94 Route: GAVAGE Time: 10:19:35 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE VEHICLE 25 MG/KG 50 MG/KG CONTROL ____________________________________________________________________________________________________________________________________ TUMOR SUMMARY Total Animals with Primary Neoplasms (b) 47 49 50 Total Primary Neoplasms 100 89 104 Total Animals with Benign Neoplasms 44 41 42 Total Benign Neoplasms 79 63 69 Total Animals with Malignant Neoplasms 18 24 32 Total Malignant Neoplasms 21 26 35 Total Animals with Metastatic Neoplasms 1 1 3 Total Metastatic Neoplasm 1 1 5 Total Animals with Malignant Neoplasms Uncertain Primary Site Total Animals with Neoplasms Uncertain- Benign or Malignant Total Uncertain Neoplasms ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion b Primary tumors: all tumors except metastatic tumors Page 6 NTP Experiment-Test: 05040-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC HYDROQUINONE Date: 09/05/94 Route: GAVAGE Time: 10:19:35 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE VEHICLE 25 MG/KG 50 MG/KG CONTROL ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially in Study 65 65 65 Scheduled Sacrifice 10 10 10 Early Deaths Moribund 13 25 22 Gavage Death 2 5 7 Dead 13 7 8 Survivors Terminal Sacrifice 27 18 18 Animals Examined Microscopically 55 55 55 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Cecum (50) (34) (50) Intestine Large, Colon (51) (35) (53) Serosa, Histiocytic Sarcoma, Metastatic 1 (2%) Intestine Large, Rectum (53) (32) (52) Intestine Small, Duodenum (52) (35) (55) Serosa, Ileum, Jejunum, Histiocytic Sarcoma, Metastatic 1 (2%) Intestine Small, Ileum (48) (33) (49) Intestine Small, Jejunum (44) (30) (48) Leiomyosarcoma 1 (2%) 1 (3%) Liver (55) (55) (55) Hepatocellular Adenoma 3 (5%) 1 (2%) Histiocytic Sarcoma 1 (2%) Histiocytic Sarcoma, Metastatic 2 (4%) 1 (2%) Leiomyosarcoma, Metastatic, Intestine Small 1 (2%) Neoplastic Nodule 2 (4%) 1 (2%) Bile Duct, Leiomyosarcoma, Extension, Metastatic, Intestine Small 1 (2%) Mesentery (12) (16) (9) Histiocytic Sarcoma, Metastatic 2 (17%) Leiomyosarcoma, Extension, Metastatic, Intestine Small 1 (8%) 1 (6%) Pancreas (53) (36) (54) Histiocytic Sarcoma, Metastatic 2 (4%) Pharynx (1) Palate, Carcinoma, Extension, Metastatic, Zymbal's Gland 1 (100%) Salivary Glands (54) (37) (55) Stomach, Forestomach (55) (36) (55) Serosa, Glandular, Histiocytic Sarcoma, Page 7 NTP Experiment-Test: 05040-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC HYDROQUINONE Date: 09/05/94 Route: GAVAGE Time: 10:19:35 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE VEHICLE 25 MG/KG 50 MG/KG CONTROL ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - cont Metastatic 1 (2%) Stomach, Glandular (54) (34) (55) Tongue (2) Squamous Cell Papilloma 1 (50%) Tooth (8) (9) (10) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (55) (38) (55) Schwannoma NOS 1 (2%) Atrium, Histiocytic Sarcoma, Metastatic 1 (3%) Atrium Right, Liposarcoma, Metastatic, Skin 1 (3%) Endocardium, Schwannoma NOS 2 (4%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Gland, Cortex (54) (37) (54) Histiocytic Sarcoma, Metastatic 1 (2%) Adrenal Gland, Medulla (55) (48) (55) Pheochromocytoma Malignant 1 (2%) 2 (4%) 3 (5%) Pheochromocytoma Benign 9 (16%) 14 (29%) 13 (24%) Bilateral, Pheochromocytoma Benign 4 (7%) 3 (6%) 6 (11%) Islets, Pancreatic (54) (36) (54) Adenoma 1 (2%) 1 (3%) Parathyroid Gland (54) (36) (54) Pituitary Gland (54) (54) (54) Pars Distalis, Adenoma 13 (24%) 9 (17%) 5 (9%) Pars Distalis, Carcinoma 1 (2%) Thyroid Gland (55) (38) (55) Histiocytic Sarcoma, Metastatic 1 (2%) C-Cell, Adenoma 5 (9%) 2 (5%) 3 (5%) C-Cell, Carcinoma 2 (4%) 2 (5%) 3 (5%) Follicular Cell, Adenocarcinoma 2 (4%) Follicular Cell, Adenoma 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ Page 8 NTP Experiment-Test: 05040-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC HYDROQUINONE Date: 09/05/94 Route: GAVAGE Time: 10:19:35 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE VEHICLE 25 MG/KG 50 MG/KG CONTROL ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Coagulating Gland (1) (2) Epididymis (53) (37) (55) Histiocytic Sarcoma, Metastatic 1 (2%) Penis (1) Preputial Gland (53) (34) (54) Adenoma 11 (21%) 8 (24%) 7 (13%) Carcinoma 1 (2%) 1 (3%) 3 (6%) Histiocytic Sarcoma, Metastatic 1 (2%) Prostate (53) (41) (55) Adenoma 1 (2%) Serosa, Histiocytic Sarcoma, Metastatic 1 (2%) Seminal Vesicle (53) (36) (55) Serosa, Histiocytic Sarcoma, Metastatic 1 (2%) Testes (54) (54) (55) Bilateral, Interstitial Cell, Adenoma 37 (69%) 36 (67%) 43 (78%) Interstitial Cell, Adenoma 9 (17%) 13 (24%) 6 (11%) Tunic, Histiocytic Sarcoma, Metastatic 1 (2%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Blood (22) (25) (29) Histiocytic Sarcoma, Metastatic 1 (5%) Bone Marrow (55) (37) (55) Histiocytic Sarcoma, Metastatic 1 (2%) Lymph Node (55) (41) (55) Mediastinal, Histiocytic Sarcoma, Metastatic 1 (2%) Lymph Node, Mandibular (52) (38) (54) Lymph Node, Mesenteric (53) (38) (54) Inguinal, Lumbar, Mediastinal, Histiocytic Sarcoma, Metastatic 1 (2%) Mediastinal, Mandibular, Histiocytic Sarcoma, Metastatic 1 (2%) Spleen (55) (52) (55) Histiocytic Sarcoma, Metastatic 1 (2%) Leiomyosarcoma, Metastatic, Intestine Small 1 (2%) Capsule, Histiocytic Sarcoma, Metastatic 1 (2%) Thymus (46) (35) (46) Histiocytic Sarcoma, Metastatic 1 (2%) ____________________________________________________________________________________________________________________________________ Page 9 NTP Experiment-Test: 05040-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC HYDROQUINONE Date: 09/05/94 Route: GAVAGE Time: 10:19:35 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE VEHICLE 25 MG/KG 50 MG/KG CONTROL ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (49) (29) (53) Adenocarcinoma 1 (2%) Adenoma 1 (2%) Fibroadenoma 3 (6%) Histiocytic Sarcoma, Metastatic 1 (2%) Skin (55) (37) (54) Basal Cell Adenoma 2 (4%) Basosquamous Tumor Malignant 1 (3%) Keratoacanthoma 2 (4%) 2 (4%) Subcutaneous Tissue, Fibroma 1 (2%) 1 (3%) Subcutaneous Tissue, Fibrosarcoma 1 (2%) 1 (3%) Subcutaneous Tissue, Histiocytic Sarcoma 2 (4%) 1 (3%) Subcutaneous Tissue, Lipoma 1 (3%) Subcutaneous Tissue, Liposarcoma 1 (3%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (55) (37) (55) Rib, Osteosarcoma 1 (2%) Skeletal Muscle (4) (3) (6) Histiocytic Sarcoma, Metastatic 1 (25%) Leiomyosarcoma, Metastatic, Intestine Small 1 (33%) Osteosarcoma, Extension, Metastatic, Bone 1 (17%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (55) (37) (55) Meninges, Cerebrum, Histiocytic Sarcoma, Metastatic 1 (3%) Spinal Cord (13) (13) (9) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (55) (38) (55) Alveolar/Bronchiolar Adenoma 1 (2%) Carcinoma, Metastatic, Zymbal's Gland 1 (3%) Histiocytic Sarcoma 1 (2%) Histiocytic Sarcoma, Metastatic 2 (4%) 1 (3%) Liposarcoma, Metastatic, Skin 1 (3%) Osteosarcoma, Metastatic, Bone 1 (2%) Pheochromocytoma Malignant, Metastatic, Adrenal Gland 1 (2%) Nose (55) (37) (55) Page 10 NTP Experiment-Test: 05040-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC HYDROQUINONE Date: 09/05/94 Route: GAVAGE Time: 10:19:35 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE VEHICLE 25 MG/KG 50 MG/KG CONTROL ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM - cont Trachea (53) (37) (55) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Ear (2) (2) Canal, Carcinoma, Extension, Metastatic, Zymbal's Gland 1 (50%) Eye (2) (3) (4) Harderian Gland (2) (2) (3) Zymbal's Gland (3) (4) (1) Adenoma 1 (25%) Carcinoma 1 (33%) 3 (75%) 1 (100%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (55) (55) (55) Histiocytic Sarcoma 1 (2%) Capsule, Histiocytic Sarcoma, Metastatic 1 (2%) Renal Tubule, Adenoma 4 (7%) 8 (15%) Urinary Bladder (51) (37) (55) Serosa, Histiocytic Sarcoma, Metastatic 1 (2%) Transitional Epithelium, Carcinoma, Papillary 1 (3%) ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS Multiple Organs *(55) *(55) *(55) Histiocytic Sarcoma 2 (4%) 1 (2%) 1 (2%) Leukemia Mononuclear 28 (51%) 26 (47%) 31 (56%) Mesothelioma Malignant 1 (2%) 3 (5%) 1 (2%) ____________________________________________________________________________________________________________________________________ * Number of animals with any tissue examined microscopically Page 11 NTP Experiment-Test: 05040-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC HYDROQUINONE Date: 09/05/94 Route: GAVAGE Time: 10:19:35 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE VEHICLE 25 MG/KG 50 MG/KG CONTROL ____________________________________________________________________________________________________________________________________ TUMOR SUMMARY Total Animals with Primary Neoplasms (b) 53 53 54 Total Primary Neoplasms 145 140 143 Total Animals with Benign Neoplasms 50 50 52 Total Benign Neoplasms 102 96 98 Total Animals with Malignant Neoplasms 35 37 38 Total Malignant Neoplasms 41 44 44 Total Animals with Metastatic Neoplasms 5 6 2 Total Metastatic Neoplasm 37 34 3 Total Animals with Malignant Neoplasms Uncertain Primary Site Total Animals with Neoplasms Uncertain- Benign or Malignant 2 1 Total Uncertain Neoplasms 2 1 ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion b Primary tumors: all tumors except metastatic tumors Page 12 ------------------------------------------------------------ ---------- END OF REPORT 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