TOXICOLOGY DATA MANAGEMENT SYSTEM HISTORICAL CONTROL TUMOR INCIDENCE SUMMARY =========================================================================== ALL ORGANS FISCHER344 RATS DERMAL ETHANOL (Updated 12/99) Males(6 studies) Females(6 studies) =========================================================================== Benign Tumors Total 289/302(95.7%) 230/301(76.4%) Mean(sd) 95.7%(1.5) 76.4%(6.6) Range 47/50 - 49/50 33/50 - 43/50 Males 50/52 47/50 49/50 48/50 48/50 47/50 Females 38/51 38/50 40/50 43/50 33/50 38/50 --------------------------------------------------------------------------- Malignant Tumors Total 151/302(50%) 111/301(36.9%) Mean(sd) 50.0%(9.3) 36.9%(7.7) Range 20/50 - 32/50 12/50 - 23/50 Males 30/52 32/50 20/50 25/50 23/50 21/50 Females 22/51 17/50 23/50 19/50 18/50 12/50 --------------------------------------------------------------------------- Malignant and Benign Total 300/302(99.3%) 262/301(87%) Tumors Mean(sd) 99.3%(1.0) 87.1%(6.6) Range 49/50 - 52/52 40/50 - 48/50 Males 52/52 50/50 50/50 49/50 50/50 49/50 Females 43/51 46/50 45/50 48/50 40/50 40/50 --------------------------------------------------------------------------- Hemangioma Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Hemangiosarcoma Total 3/302(1%) 1/301(0.3%) Mean(sd) 1.0%(1.6) 0.3%(0.8) Range 0/50 - 2/52 0/51 - 1/50 Males 2/52 0/50 0/50 0/50 0/50 1/50 Females 0/51 1/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Hemangiosarcoma or Total 3/302(1%) 1/301(0.3%) Hemangioma Mean(sd) 1.0%(1.6) 0.3%(0.8) Range 0/50 - 2/52 0/51 - 1/50 Males 2/52 0/50 0/50 0/50 0/50 1/50 Females 0/51 1/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Histiocytic Sarcoma Total 3/302(1%) 2/301(0.7%) Mean(sd) 1.0%(2.4) 0.7%(1.0) Range 0/50 - 3/52 0/51 - 1/50 Males 3/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 1/50 0/50 1/50 --------------------------------------------------------------------------- Leukemia: Granulocytic Total 2/302(0.7%) 0/301(0%) Mean(sd) 0.7%(1.0) 0.0%(0.0) Range 0/52 - 1/50 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 1/50 1/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Leukemia: Lymphocytic, Total 94/302(31.1%) 71/301(23.6%) Monocytic, Mononuclear, Mean(sd) 31.0%(12.8) 23.6%(9.6) or Undifferentiated Range 6/50 - 23/50 5/50 - 18/51 Males 23/52 23/50 12/50 16/50 6/50 14/50 Females 18/51 11/50 17/50 10/50 10/50 5/50 --------------------------------------------------------------------------- Malignant Lymphoma: Total 2/302(0.7%) 1/301(0.3%) Histiocytic, Mean(sd) 0.7%(1.0) 0.3%(0.8) Lymphocytic, Mixed, NOS, Range 0/52 - 1/50 0/51 - 1/50 or Undifferentiated Cell Type Males 0/52 1/50 0/50 0/50 0/50 1/50 Females 0/51 0/50 0/50 0/50 1/50 0/50 --------------------------------------------------------------------------- Mesothelioma: Benign Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Mesothelioma: Benign, Total 14/302(4.6%) 1/301(0.3%) Malignant, NOS Mean(sd) 4.7%(3.7) 0.3%(0.8) Range 1/52 - 6/50 0/51 - 1/50 Males 1/52 2/50 1/50 2/50 6/50 2/50 Females 0/51 0/50 0/50 0/50 1/50 0/50 --------------------------------------------------------------------------- Mesothelioma: Malignant Total 14/302(4.6%) 1/301(0.3%) Mean(sd) 4.7%(3.7) 0.3%(0.8) Range 1/52 - 6/50 0/51 - 1/50 Males 1/52 2/50 1/50 2/50 6/50 2/50 Females 0/51 0/50 0/50 0/50 1/50 0/50 --------------------------------------------------------------------------- Osteoma Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Osteosarcoma Total 3/302(1%) 2/301(0.7%) Mean(sd) 1.0%(1.7) 0.7%(1.0) Range 0/50 - 2/50 0/51 - 1/50 Males 1/52 2/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 1/50 1/50 0/50 0/50 --------------------------------------------------------------------------- Osteosarcoma or Osteoma Total 3/302(1%) 2/301(0.7%) Mean(sd) 1.0%(1.7) 0.7%(1.0) Range 0/50 - 2/50 0/51 - 1/50 Males 1/52 2/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 1/50 1/50 0/50 0/50 --------------------------------------------------------------------------- =========================================================================== ADRENAL CORTEX FISCHER344 RATS DERMAL ETHANOL (Updated 12/99) Males(6 studies) Females(6 studies) =========================================================================== Adenoma Total 1/250(0.4%) 2/250(0.8%) Mean(sd) 0.4%(0.9) 0.8%(1.1) Range 0/50 - 1/50 0/50 - 1/50 Males 0/0 0/50 1/50 0/50 0/50 0/50 Females 0/0 0/50 1/50 0/50 1/50 0/50 --------------------------------------------------------------------------- Carcinoma Total 0/250(0%) 0/250(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/50 - 0/50 0/50 - 0/50 Males 0/0 0/50 0/50 0/50 0/50 0/50 Females 0/0 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- =========================================================================== ADRENAL MEDULLA FISCHER344 RATS DERMAL ETHANOL (Updated 12/99) Males(6 studies) Females(6 studies) =========================================================================== Ganglioneuroma Total 0/250(0%) 0/249(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/50 - 0/50 0/49 - 0/49 Males 0/0 0/50 0/50 0/50 0/50 0/50 Females 0/0 0/49 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Pheochromocytoma Benign Total 37/250(14.8%) 3/249(1.2%) Mean(sd) 14.8%(7.4) 1.2%(1.8) Range 2/50 - 12/50 0/49 - 2/50 Males 0/0 9/50 8/50 6/50 2/50 12/50 Females 0/0 0/49 1/50 0/50 0/50 2/50 --------------------------------------------------------------------------- Pheochromocytoma Complex Total 0/250(0%) 0/249(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/50 - 0/50 0/49 - 0/49 Males 0/0 0/50 0/50 0/50 0/50 0/50 Females 0/0 0/49 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Pheochromocytoma Total 3/250(1.2%) 0/249(0%) Malignant Mean(sd) 1.2%(1.8) 0.0%(0.0) Range 0/50 - 2/50 0/49 - 0/49 Males 0/0 1/50 0/50 0/50 2/50 0/50 Females 0/0 0/49 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Pheochromocytoma: Total 40/250(16%) 3/249(1.2%) Benign, Complex, Mean(sd) 16.0%(6.3) 1.2%(1.8) Malignant, NOS Range 4/50 - 12/50 0/49 - 2/50 Males 0/0 10/50 8/50 6/50 4/50 12/50 Females 0/0 0/49 1/50 0/50 0/50 2/50 --------------------------------------------------------------------------- =========================================================================== BONE MARROW FISCHER344 RATS DERMAL ETHANOL (Updated 12/99) Males(6 studies) Females(6 studies) =========================================================================== Fibrosarcoma Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- =========================================================================== BONE FISCHER344 RATS DERMAL ETHANOL (Updated 12/99) Males(6 studies) Females(6 studies) =========================================================================== Chondroma Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Chondrosarcoma Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Chondrosarcoma or Total 0/302(0%) 0/301(0%) Chondroma Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Chordoma Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Fibroma Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Fibrosarcoma Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Hemangiosarcoma Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Osteoma Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Osteosarcoma Total 3/302(1%) 2/301(0.7%) Mean(sd) 1.0%(1.7) 0.7%(1.0) Range 0/50 - 2/50 0/51 - 1/50 Males 1/52 2/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 1/50 1/50 0/50 0/50 --------------------------------------------------------------------------- Osteosarcoma or Osteoma Total 3/302(1%) 2/301(0.7%) Mean(sd) 1.0%(1.7) 0.7%(1.0) Range 0/50 - 2/50 0/51 - 1/50 Males 1/52 2/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 1/50 1/50 0/50 0/50 --------------------------------------------------------------------------- Sarcoma Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- =========================================================================== BRAIN FISCHER344 RATS DERMAL ETHANOL (Updated 12/99) Males(6 studies) Females(6 studies) =========================================================================== Astrocytoma Benign Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Astrocytoma Malignant Total 2/302(0.7%) 2/301(0.7%) Mean(sd) 0.7%(1.0) 0.7%(1.0) Range 0/52 - 1/50 0/51 - 1/50 Males 0/52 1/50 1/50 0/50 0/50 0/50 Females 0/51 1/50 1/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Astrocytoma NOS Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Carcinoma Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Glioma Malignant Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Glioma Malignant, Mixed Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Glioma NOS Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Granular Cell Tumor Total 0/302(0%) 0/301(0%) Benign Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Granular Cell Tumor Total 0/302(0%) 0/301(0%) Malignant Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Hemangioma Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Meningioma Benign Total 1/302(0.3%) 0/301(0%) Mean(sd) 0.3%(0.8) 0.0%(0.0) Range 0/52 - 1/50 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 1/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Meningioma Malignant Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Meningioma: Benign, Total 1/302(0.3%) 0/301(0%) Malignant, NOS Mean(sd) 0.3%(0.8) 0.0%(0.0) Range 0/52 - 1/50 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 1/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Oligodendroglioma Benign Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Oligodendroglioma Total 0/302(0%) 0/301(0%) Malignant Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Oligodendroglioma NOS Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Oligodendroglioma, Total 2/302(0.7%) 2/301(0.7%) Glioma, or Astrocytoma Mean(sd) 0.7%(1.0) 0.7%(1.0) Range 0/52 - 1/50 0/51 - 1/50 Males 0/52 1/50 1/50 0/50 0/50 0/50 Females 0/51 1/50 1/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Sarcoma Total 1/302(0.3%) 0/301(0%) Mean(sd) 0.3%(0.8) 0.0%(0.0) Range 0/52 - 1/50 0/51 - 0/51 Males 0/52 0/50 0/50 1/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Schwannoma Malignant Total 1/302(0.3%) 0/301(0%) Mean(sd) 0.3%(0.8) 0.0%(0.0) Range 0/52 - 1/50 0/51 - 0/51 Males 0/52 0/50 0/50 1/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- =========================================================================== CLITORAL/PREPUTIAL GLAND FISCHER344 RATS DERMAL ETHANOL (Updated 12/99) Males(6 studies) Females(6 studies) =========================================================================== Adenoma Total 7/302(2.3%) 33/296(11.1%) Mean(sd) 2.3%(2.9) 11.2%(7.0) Range 0/52 - 4/50 1/49 - 10/49 Males 0/52 1/50 1/50 1/50 4/50 0/50 Females 3/50 4/50 1/49 8/49 7/49 10/49 --------------------------------------------------------------------------- Carcinoma Total 4/302(1.3%) 5/296(1.7%) Mean(sd) 1.3%(2.0) 1.7%(2.7) Range 0/50 - 2/50 0/50 - 3/49 Males 2/52 0/50 0/50 0/50 2/50 0/50 Females 0/50 0/50 0/49 2/49 3/49 0/49 --------------------------------------------------------------------------- Carcinoma or Adenoma Total 11/302(3.6%) 37/296(12.5%) Mean(sd) 3.6%(4.3) 12.5%(8.2) Range 0/50 - 6/50 1/49 - 10/49 Males 2/52 1/50 1/50 1/50 6/50 0/50 Females 3/50 4/50 1/49 9/49 10/49 10/49 --------------------------------------------------------------------------- Squamous Cell Carcinoma Total 0/302(0%) 0/296(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/50 - 0/50 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/50 0/50 0/49 0/49 0/49 0/49 --------------------------------------------------------------------------- Squamous Cell Papilloma Total 0/302(0%) 0/296(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/50 - 0/50 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/50 0/50 0/49 0/49 0/49 0/49 --------------------------------------------------------------------------- =========================================================================== EAR FISCHER344 RATS DERMAL ETHANOL (Updated 12/99) Males(6 studies) Females(6 studies) =========================================================================== Fibroma Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Fibrosarcoma Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Neurofibrosarcoma Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Sarcoma Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Schwannoma Benign Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Schwannoma NOS Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Squamous Cell Carcinoma Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Squamous Cell Papilloma Total 3/302(1%) 0/301(0%) Mean(sd) 1.0%(2.4) 0.0%(0.0) Range 0/50 - 3/52 0/51 - 0/51 Males 3/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- =========================================================================== ESOPHAGUS FISCHER344 RATS DERMAL ETHANOL (Updated 12/99) Males(6 studies) Females(6 studies) =========================================================================== Fibrosarcoma Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Squamous Cell Carcinoma Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- =========================================================================== EYE FISCHER344 RATS DERMAL ETHANOL (Updated 12/99) Males(6 studies) Females(6 studies) =========================================================================== Melanoma NOS Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- =========================================================================== HARDERIAN GLAND FISCHER344 RATS DERMAL ETHANOL (Updated 12/99) Males(6 studies) Females(6 studies) =========================================================================== Adenoma Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Carcinoma or Adenoma Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Schwannoma Malignant Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- =========================================================================== HEART FISCHER344 RATS DERMAL ETHANOL (Updated 12/99) Males(6 studies) Females(6 studies) =========================================================================== Fibroma Total 0/301(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/51 - 0/51 0/51 - 0/51 Males 0/51 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Schwannoma Benign Total 0/301(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/51 - 0/51 0/51 - 0/51 Males 0/51 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Schwannoma Malignant Total 0/301(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/51 - 0/51 0/51 - 0/51 Males 0/51 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Schwannoma NOS Total 0/301(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/51 - 0/51 0/51 - 0/51 Males 0/51 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- =========================================================================== INTESTINE LARGE: CECUM FISCHER344 RATS DERMAL ETHANOL (Updated 12/99) Males(6 studies) Females(6 studies) =========================================================================== Hemangiosarcoma Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- =========================================================================== INTESTINE LARGE: COLON/RECTUM FISCHER344 RATS DERMAL ETHANOL (Updated 12/99) Males(6 studies) Females(6 studies) =========================================================================== Carcinoma Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Carcinoma or Adenoma Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Fibroma Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Leiomyoma Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Leiomyosarcoma Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Polyp Adenomatous Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Sarcoma Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Schwannoma Malignant Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- =========================================================================== INTESTINE SMALL: DUODENUM FISCHER344 RATS DERMAL ETHANOL (Updated 12/99) Males(6 studies) Females(6 studies) =========================================================================== Carcinoma Total 0/302(0%) 1/301(0.3%) Mean(sd) 0.0%(0.0) 0.3%(0.8) Range 0/52 - 0/52 0/51 - 1/50 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 1/50 --------------------------------------------------------------------------- Leiomyoma Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Leiomyosarcoma Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Polyp Adenomatous Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- =========================================================================== INTESTINE SMALL: ILEUM FISCHER344 RATS DERMAL ETHANOL (Updated 12/99) Males(6 studies) Females(6 studies) =========================================================================== Carcinoma Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Leiomyosarcoma Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- =========================================================================== INTESTINE SMALL: JEJUNUM FISCHER344 RATS DERMAL ETHANOL (Updated 12/99) Males(6 studies) Females(6 studies) =========================================================================== Adenoma Total 1/302(0.3%) 0/301(0%) Mean(sd) 0.3%(0.8) 0.0%(0.0) Range 0/50 - 1/52 0/51 - 0/51 Males 1/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Carcinoma Total 1/302(0.3%) 0/301(0%) Mean(sd) 0.3%(0.8) 0.0%(0.0) Range 0/52 - 1/50 0/51 - 0/51 Males 0/52 0/50 1/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Fibroma Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Fibrosarcoma Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Leiomyoma Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Leiomyosarcoma Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Mast Cell Tumor Benign Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Polyp Adenomatous Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- =========================================================================== INTESTINE SMALL: SITE UNSPECIFIED FISCHER344 RATS DERMAL ETHANOL (Updated 12/99) Males(6 studies) Females(6 studies) =========================================================================== Adenoma Total 1/302(0.3%) 0/301(0%) Mean(sd) 0.3%(0.8) 0.0%(0.0) Range 0/50 - 1/52 0/51 - 0/51 Males 1/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Carcinoma Total 1/302(0.3%) 1/301(0.3%) Mean(sd) 0.3%(0.8) 0.3%(0.8) Range 0/52 - 1/50 0/51 - 1/50 Males 0/52 0/50 1/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 1/50 --------------------------------------------------------------------------- Carcinoma or Adenoma Total 2/302(0.7%) 1/301(0.3%) Mean(sd) 0.7%(1.0) 0.3%(0.8) Range 0/50 - 1/50 0/51 - 1/50 Males 1/52 0/50 1/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 1/50 --------------------------------------------------------------------------- Fibroma Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Fibrosarcoma Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Leiomyoma Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Leiomyosarcoma Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Mast Cell Tumor Benign Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Polyp Adenomatous Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- =========================================================================== ISLETS, PANCREATIC FISCHER344 RATS DERMAL ETHANOL (Updated 12/99) Males(6 studies) Females(6 studies) =========================================================================== Adenoma Total 15/302(5%) 1/301(0.3%) Mean(sd) 5.0%(3.1) 0.3%(0.8) Range 1/52 - 5/50 0/51 - 1/50 Males 1/52 3/50 5/50 3/50 2/50 1/50 Females 0/51 0/50 0/50 1/50 0/50 0/50 --------------------------------------------------------------------------- Carcinoma Total 8/302(2.6%) 1/301(0.3%) Mean(sd) 2.7%(3.3) 0.3%(0.8) Range 0/52 - 4/50 0/51 - 1/50 Males 0/52 2/50 0/50 0/50 4/50 2/50 Females 0/51 0/50 1/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Carcinoma or Adenoma Total 23/302(7.6%) 2/301(0.7%) Mean(sd) 7.7%(3.7) 0.7%(1.0) Range 1/52 - 6/50 0/51 - 1/50 Males 1/52 5/50 5/50 3/50 6/50 3/50 Females 0/51 0/50 1/50 1/50 0/50 0/50 --------------------------------------------------------------------------- =========================================================================== KIDNEY: PELVIS AND TRANSITIONAL EPITHELIUM FISCHER344 RATS DERMAL ETHANOL (Updated 12/99) Males(6 studies) Females(6 studies) =========================================================================== Carcinoma Total 1/302(0.3%) 0/301(0%) Mean(sd) 0.3%(0.8) 0.0%(0.0) Range 0/50 - 1/52 0/51 - 0/51 Males 1/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Carcinoma or Adenoma Total 1/302(0.3%) 0/301(0%) Mean(sd) 0.3%(0.8) 0.0%(0.0) Range 0/50 - 1/52 0/51 - 0/51 Males 1/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Papilloma Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- =========================================================================== KIDNEY: RENAL TUBULE FISCHER344 RATS DERMAL ETHANOL (Updated 12/99) Males(6 studies) Females(6 studies) =========================================================================== Adenoma Total 6/302(2%) 1/301(0.3%) Mean(sd) 2.0%(2.5) 0.3%(0.8) Range 0/52 - 3/50 0/51 - 1/50 Males 0/52 0/50 2/50 1/50 0/50 3/50 Females 0/51 0/50 0/50 0/50 1/50 0/50 --------------------------------------------------------------------------- Carcinoma Total 1/302(0.3%) 0/301(0%) Mean(sd) 0.3%(0.8) 0.0%(0.0) Range 0/52 - 1/50 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 1/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Carcinoma or Adenoma Total 7/302(2.3%) 1/301(0.3%) Mean(sd) 2.3%(3.2) 0.3%(0.8) Range 0/52 - 4/50 0/51 - 1/50 Males 0/52 0/50 2/50 1/50 0/50 4/50 Females 0/51 0/50 0/50 0/50 1/50 0/50 --------------------------------------------------------------------------- Lipoma Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Liposarcoma Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Mesenchymal Tumor Benign Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Nephroblastoma Total 1/302(0.3%) 0/301(0%) Mean(sd) 0.3%(0.8) 0.0%(0.0) Range 0/52 - 1/50 0/51 - 0/51 Males 0/52 1/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Oncocytoma Benign Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Sarcoma Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Stromal Nephroma Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- =========================================================================== LACRIMAL GLAND FISCHER344 RATS DERMAL ETHANOL (Updated 12/99) Males(6 studies) Females(6 studies) =========================================================================== Carcinoma Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- =========================================================================== LIVER FISCHER344 RATS DERMAL ETHANOL (Updated 12/99) Males(6 studies) Females(6 studies) =========================================================================== Cholangiocarcinoma Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Cholangioma Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Fibrosarcoma Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Hepatocellular Adenoma Total 0/302(0%) 2/301(0.7%) Mean(sd) 0.0%(0.0) 0.7%(1.0) Range 0/52 - 0/52 0/51 - 1/50 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 1/50 0/50 0/50 0/50 1/50 --------------------------------------------------------------------------- Hepatocellular Carcinoma Total 1/302(0.3%) 0/301(0%) Mean(sd) 0.3%(0.8) 0.0%(0.0) Range 0/52 - 1/50 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 1/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Hepatocellular Total 1/302(0.3%) 0/301(0%) Carcinoma or Mean(sd) 0.3%(0.8) 0.0%(0.0) Hepatoblastoma Range 0/52 - 1/50 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 1/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Hepatocellular Total 1/302(0.3%) 2/301(0.7%) Carcinoma or Mean(sd) 0.3%(0.8) 0.7%(1.0) Hepatocellular Adenoma Range 0/52 - 1/50 0/51 - 1/50 Males 0/52 0/50 0/50 0/50 0/50 1/50 Females 0/51 1/50 0/50 0/50 0/50 1/50 --------------------------------------------------------------------------- Hepatocellular Total 1/302(0.3%) 2/301(0.7%) Carcinoma, Mean(sd) 0.3%(0.8) 0.7%(1.0) Hepatocellular Adenoma, Range 0/52 - 1/50 0/51 - 1/50 or Hepatoblastoma Males 0/52 0/50 0/50 0/50 0/50 1/50 Females 0/51 1/50 0/50 0/50 0/50 1/50 --------------------------------------------------------------------------- =========================================================================== LUNG FISCHER344 RATS DERMAL ETHANOL (Updated 12/99) Males(6 studies) Females(6 studies) =========================================================================== Alveolar/Bronchiolar Total 1/301(0.3%) 5/301(1.7%) Adenoma Mean(sd) 0.3%(0.8) 1.7%(1.5) Range 0/51 - 1/50 0/51 - 2/50 Males 0/51 0/50 1/50 0/50 0/50 0/50 Females 0/51 2/50 1/50 0/50 1/50 1/50 --------------------------------------------------------------------------- Alveolar/Bronchiolar Total 2/301(0.7%) 0/301(0%) Carcinoma Mean(sd) 0.7%(1.6) 0.0%(0.0) Range 0/51 - 2/50 0/51 - 0/51 Males 0/51 0/50 2/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Alveolar/Bronchiolar Total 3/301(1%) 5/301(1.7%) Carcinoma or Mean(sd) 1.0%(2.4) 1.7%(1.5) Alveolar/Bronchiolar Range 0/51 - 3/50 0/51 - 2/50 Adenoma Males 0/51 0/50 3/50 0/50 0/50 0/50 Females 0/51 2/50 1/50 0/50 1/50 1/50 --------------------------------------------------------------------------- Carcinoma Total 0/301(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/51 - 0/51 0/51 - 0/51 Males 0/51 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Fibrosarcoma Total 0/301(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/51 - 0/51 0/51 - 0/51 Males 0/51 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Schwannoma Malignant Total 0/301(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/51 - 0/51 0/51 - 0/51 Males 0/51 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Squamous Cell Carcinoma Total 0/301(0%) 2/301(0.7%) Mean(sd) 0.0%(0.0) 0.7%(1.0) Range 0/51 - 0/51 0/51 - 1/50 Males 0/51 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 1/50 1/50 --------------------------------------------------------------------------- =========================================================================== LYMPH NODE, BRONCHIAL FISCHER344 RATS DERMAL ETHANOL (Updated 12/99) Males(6 studies) Females(6 studies) =========================================================================== Plasma Cell Tumor Total 0/302(0%) 0/301(0%) Malignant Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- =========================================================================== LYMPH NODE, MANDIBULAR FISCHER344 RATS DERMAL ETHANOL (Updated 12/99) Males(6 studies) Females(6 studies) =========================================================================== Hemangiosarcoma Total 1/302(0.3%) 0/301(0%) Mean(sd) 0.3%(0.8) 0.0%(0.0) Range 0/50 - 1/52 0/51 - 0/51 Males 1/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- =========================================================================== LYMPH NODE, MEDIASTINAL FISCHER344 RATS DERMAL ETHANOL (Updated 12/99) Males(6 studies) Females(6 studies) =========================================================================== Plasma Cell Tumor Total 0/302(0%) 0/301(0%) Malignant Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- =========================================================================== LYMPH NODE, MESENTERIC FISCHER344 RATS DERMAL ETHANOL (Updated 12/99) Males(6 studies) Females(6 studies) =========================================================================== Hemangiosarcoma Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- =========================================================================== LYMPH NODE FISCHER344 RATS DERMAL ETHANOL (Updated 12/99) Males(6 studies) Females(6 studies) =========================================================================== Sarcoma Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- =========================================================================== MAMMARY GLAND FISCHER344 RATS DERMAL ETHANOL (Updated 12/99) Males(6 studies) Females(6 studies) =========================================================================== Adenoacanthoma Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Adenoma Total 2/302(0.7%) 5/301(1.7%) Mean(sd) 0.7%(1.0) 1.7%(2.3) Range 0/50 - 1/50 0/50 - 3/51 Males 1/52 0/50 0/50 1/50 0/50 0/50 Females 3/51 0/50 0/50 1/50 1/50 0/50 --------------------------------------------------------------------------- Carcinoma Total 1/302(0.3%) 4/301(1.3%) Mean(sd) 0.3%(0.8) 1.3%(1.6) Range 0/52 - 1/50 0/51 - 2/50 Males 0/52 0/50 0/50 0/50 0/50 1/50 Females 0/51 0/50 1/50 2/50 0/50 1/50 --------------------------------------------------------------------------- Carcinoma or Adenoma Total 3/302(1%) 9/301(3%) Mean(sd) 1.0%(1.1) 3.0%(2.4) Range 0/50 - 1/50 0/50 - 3/50 Males 1/52 0/50 0/50 1/50 0/50 1/50 Females 3/51 0/50 1/50 3/50 1/50 1/50 --------------------------------------------------------------------------- Fibroadenoma Total 10/302(3.3%) 85/301(28.2%) Mean(sd) 3.3%(1.6) 28.2%(7.0) Range 1/52 - 3/50 9/50 - 18/50 Males 1/52 1/50 1/50 2/50 2/50 3/50 Females 17/51 14/50 16/50 18/50 11/50 9/50 --------------------------------------------------------------------------- Fibroma Total 3/302(1%) 0/301(0%) Mean(sd) 1.0%(2.4) 0.0%(0.0) Range 0/50 - 3/52 0/51 - 0/51 Males 3/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Fibroma, Fibroadenoma Total 15/302(5%) 87/301(28.9%) or Adenoma Mean(sd) 4.9%(2.9) 28.9%(7.7) Range 1/50 - 5/52 9/50 - 19/51 Males 5/52 1/50 1/50 3/50 2/50 3/50 Females 19/51 14/50 16/50 18/50 11/50 9/50 --------------------------------------------------------------------------- Fibroma, Fibroadenoma, Total 16/302(5.3%) 90/301(29.9%) Carcinoma, or Adenoma Mean(sd) 5.3%(3.2) 29.9%(8.1) Range 1/50 - 5/52 10/50 - 20/50 Males 5/52 1/50 1/50 3/50 2/50 4/50 Females 19/51 14/50 16/50 20/50 11/50 10/50 --------------------------------------------------------------------------- Fibrosarcoma Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Lipoma Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Sarcoma Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- =========================================================================== MESENTERY FISCHER344 RATS DERMAL ETHANOL (Updated 12/99) Males(6 studies) Females(6 studies) =========================================================================== Fibrosarcoma Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Fibrous Histiocytoma Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Lipoma Total 1/302(0.3%) 0/301(0%) Mean(sd) 0.3%(0.8) 0.0%(0.0) Range 0/50 - 1/52 0/51 - 0/51 Males 1/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Liposarcoma Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Sarcoma Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Schwannoma Benign Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Schwannoma Malignant Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- =========================================================================== NOSE FISCHER344 RATS DERMAL ETHANOL (Updated 12/99) Males(6 studies) Females(6 studies) =========================================================================== Adenoma Total 0/302(0%) 0/299(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/49 0/50 0/50 0/50 0/49 --------------------------------------------------------------------------- Carcinoma Total 0/302(0%) 0/299(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/49 0/50 0/50 0/50 0/49 --------------------------------------------------------------------------- Chondroma Total 0/302(0%) 0/299(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/49 0/50 0/50 0/50 0/49 --------------------------------------------------------------------------- Chondrosarcoma Total 0/302(0%) 0/299(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/49 0/50 0/50 0/50 0/49 --------------------------------------------------------------------------- Fibroma Total 0/302(0%) 0/299(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/49 0/50 0/50 0/50 0/49 --------------------------------------------------------------------------- Osteoma Total 0/302(0%) 0/299(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/49 0/50 0/50 0/50 0/49 --------------------------------------------------------------------------- Osteosarcoma Total 0/302(0%) 0/299(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/49 0/50 0/50 0/50 0/49 --------------------------------------------------------------------------- Squamous Cell Carcinoma Total 0/302(0%) 1/299(0.3%) Mean(sd) 0.0%(0.0) 0.3%(0.8) Range 0/52 - 0/52 0/49 - 1/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 1/51 0/49 0/50 0/50 0/50 0/49 --------------------------------------------------------------------------- Squamous Cell Papilloma Total 0/302(0%) 1/299(0.3%) Mean(sd) 0.0%(0.0) 0.3%(0.8) Range 0/52 - 0/52 0/49 - 1/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 1/51 0/49 0/50 0/50 0/50 0/49 --------------------------------------------------------------------------- =========================================================================== ORAL CAVITY (ORAL MUCOSA, TONGUE, PHARYNX, TOOTH, GINGIVA) FISCHER344 RATS DERMAL ETHANOL (Updated 12/99) Males(6 studies) Females(6 studies) =========================================================================== Papilloma Squamous or Total 4/302(1.3%) 0/301(0%) Papilloma Mean(sd) 1.3%(1.0) 0.0%(0.0) Range 0/50 - 1/50 0/51 - 0/51 Males 1/52 0/50 0/50 1/50 1/50 1/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Squamous Cell Carcinoma Total 3/302(1%) 1/301(0.3%) Mean(sd) 1.0%(1.1) 0.3%(0.8) Range 0/50 - 1/50 0/51 - 1/50 Males 1/52 1/50 1/50 0/50 0/50 0/50 Females 0/51 0/50 1/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Squamous Cell Total 7/302(2.3%) 1/301(0.3%) Carcinoma, Papilloma Mean(sd) 2.3%(0.7) 0.3%(0.8) Squamous, or Papilloma Range 1/50 - 2/52 0/51 - 1/50 Males 2/52 1/50 1/50 1/50 1/50 1/50 Females 0/51 0/50 1/50 0/50 0/50 0/50 --------------------------------------------------------------------------- =========================================================================== ORAL MUCOSA FISCHER344 RATS DERMAL ETHANOL (Updated 12/99) Males(6 studies) Females(6 studies) =========================================================================== Sarcoma Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Squamous Cell Carcinoma Total 2/302(0.7%) 1/301(0.3%) Mean(sd) 0.7%(1.0) 0.3%(0.8) Range 0/52 - 1/50 0/51 - 1/50 Males 0/52 1/50 1/50 0/50 0/50 0/50 Females 0/51 0/50 1/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Squamous Cell Papilloma Total 2/302(0.7%) 0/301(0%) Mean(sd) 0.7%(1.0) 0.0%(0.0) Range 0/52 - 1/50 0/51 - 0/51 Males 0/52 0/50 0/50 1/50 0/50 1/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- =========================================================================== OVARY FISCHER344 RATS DERMAL ETHANOL (Updated 12/99) Males(6 studies) Females(6 studies) =========================================================================== Adenoma Total 0/301(0%) Mean(sd) 0.0%(0.0) Range 0/51 - 0/51 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Arrhenoblastoma Benign Total 0/301(0%) Mean(sd) 0.0%(0.0) Range 0/51 - 0/51 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Granulosa Cell Tumor Total 0/301(0%) Benign Mean(sd) 0.0%(0.0) Range 0/51 - 0/51 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Granulosa Cell Tumor Total 0/301(0%) Malignant Mean(sd) 0.0%(0.0) Range 0/51 - 0/51 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Granulosa Cell Tumor: Total 0/301(0%) Benign, Malignant, NOS Mean(sd) 0.0%(0.0) Range 0/51 - 0/51 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Granulosa-Theca Tumor Total 0/301(0%) Benign Mean(sd) 0.0%(0.0) Range 0/51 - 0/51 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Granulosa-Theca Tumor Total 1/301(0.3%) Malignant Mean(sd) 0.3%(0.8) Range 0/51 - 1/50 Females 0/51 0/50 0/50 1/50 0/50 0/50 --------------------------------------------------------------------------- Luteoma Total 0/301(0%) Mean(sd) 0.0%(0.0) Range 0/51 - 0/51 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Sarcoma Total 1/301(0.3%) Mean(sd) 0.3%(0.8) Range 0/51 - 1/50 Females 0/51 0/50 0/50 0/50 0/50 1/50 --------------------------------------------------------------------------- Sex Cord Stromal Total 0/301(0%) Tumor, Malignant Mean(sd) 0.0%(0.0) Range 0/51 - 0/51 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Tubulostromal Adenoma Total 0/301(0%) Mean(sd) 0.0%(0.0) Range 0/51 - 0/51 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- =========================================================================== PANCREAS FISCHER344 RATS DERMAL ETHANOL (Updated 12/99) Males(6 studies) Females(6 studies) =========================================================================== Adenoma Total 1/302(0.3%) 0/301(0%) Mean(sd) 0.3%(0.8) 0.0%(0.0) Range 0/52 - 1/50 0/51 - 0/51 Males 0/52 0/50 0/50 1/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Carcinoma Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Carcinoma or Adenoma Total 1/302(0.3%) 0/301(0%) Mean(sd) 0.3%(0.8) 0.0%(0.0) Range 0/52 - 1/50 0/51 - 0/51 Males 0/52 0/50 0/50 1/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Fibrous Histiocytoma Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Mixed Tumor Benign Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- =========================================================================== PARATHYROID GLAND FISCHER344 RATS DERMAL ETHANOL (Updated 12/99) Males(6 studies) Females(6 studies) =========================================================================== Adenoma Total 2/282(0.7%) 1/269(0.4%) Mean(sd) 0.7%(1.1) 0.4%(1.0) Range 0/46 - 1/46 0/47 - 1/42 Males 1/50 1/46 0/46 0/48 0/47 0/45 Females 0/47 0/43 0/48 1/42 0/47 0/42 --------------------------------------------------------------------------- =========================================================================== PERIPHERAL NERVE FISCHER344 RATS DERMAL ETHANOL (Updated 12/99) Males(6 studies) Females(6 studies) =========================================================================== Paraganglioma Benign Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Schwannoma Malignant Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Schwannoma: Benign, Total 0/302(0%) 0/301(0%) Malignant, NOS Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- =========================================================================== PHARYNX FISCHER344 RATS DERMAL ETHANOL (Updated 12/99) Males(6 studies) Females(6 studies) =========================================================================== Squamous Cell Carcinoma Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Squamous Cell Papilloma Total 1/302(0.3%) 0/301(0%) Mean(sd) 0.3%(0.8) 0.0%(0.0) Range 0/50 - 1/52 0/51 - 0/51 Males 1/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- =========================================================================== PITUITARY GLAND: PARS DISTALIS OR UNSPECIFIED SITE FISCHER344 RATS DERMAL ETHANOL (Updated 12/99) Males(6 studies) Females(6 studies) =========================================================================== Adenoma Total 230/302(76.2%) 168/300(56%) Mean(sd) 76.3%(13.9) 56.0%(7.1) Range 31/52 - 48/50 23/50 - 34/50 Males 31/52 32/50 44/50 37/50 48/50 38/50 Females 28/51 27/49 34/50 27/50 23/50 29/50 --------------------------------------------------------------------------- Carcinoma Total 1/302(0.3%) 5/300(1.7%) Mean(sd) 0.3%(0.8) 1.7%(2.0) Range 0/52 - 1/50 0/50 - 2/49 Males 0/52 0/50 1/50 0/50 0/50 0/50 Females 2/51 2/49 1/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Carcinoma or Adenoma Total 231/302(76.5%) 173/300(57.7%) Mean(sd) 76.6%(14.2) 57.7%(7.8) Range 31/52 - 48/50 23/50 - 35/50 Males 31/52 32/50 45/50 37/50 48/50 38/50 Females 30/51 29/49 35/50 27/50 23/50 29/50 --------------------------------------------------------------------------- Craniopharyngioma Total 0/302(0%) 0/300(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/49 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Ganglioneuroma Total 0/302(0%) 0/300(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/49 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- =========================================================================== PITUITARY GLAND: PARS INTERMEDIA FISCHER344 RATS DERMAL ETHANOL (Updated 12/99) Males(6 studies) Females(6 studies) =========================================================================== Adenoma Total 1/302(0.3%) 0/300(0%) Mean(sd) 0.3%(0.8) 0.0%(0.0) Range 0/50 - 1/52 0/51 - 0/51 Males 1/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/49 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Carcinoma Total 0/302(0%) 0/300(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/49 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Carcinoma or Adenoma Total 1/302(0.3%) 0/300(0%) Mean(sd) 0.3%(0.8) 0.0%(0.0) Range 0/50 - 1/52 0/51 - 0/51 Males 1/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/49 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- =========================================================================== PITUITARY GLAND: PARS NERVOSA FISCHER344 RATS DERMAL ETHANOL (Updated 12/99) Males(6 studies) Females(6 studies) =========================================================================== Adenoma Total 0/302(0%) 0/300(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/49 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- =========================================================================== PROSTATE FISCHER344 RATS DERMAL ETHANOL (Updated 12/99) Males(6 studies) Females(6 studies) =========================================================================== Adenoma Total 0/302(0%) Mean(sd) 0.0%(0.0) Range 0/52 - 0/52 Males 0/52 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Carcinoma Total 2/302(0.7%) Mean(sd) 0.7%(1.6) Range 0/52 - 2/50 Males 0/52 0/50 0/50 2/50 0/50 0/50 --------------------------------------------------------------------------- Carcinoma or Adenoma Total 2/302(0.7%) Mean(sd) 0.7%(1.6) Range 0/52 - 2/50 Males 0/52 0/50 0/50 2/50 0/50 0/50 --------------------------------------------------------------------------- =========================================================================== SALIVARY GLANDS FISCHER344 RATS DERMAL ETHANOL (Updated 12/99) Males(6 studies) Females(6 studies) =========================================================================== Carcinoma Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Carcinoma or Adenoma Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Sarcoma Total 1/302(0.3%) 0/301(0%) Mean(sd) 0.3%(0.8) 0.0%(0.0) Range 0/50 - 1/52 0/51 - 0/51 Males 1/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Schwannoma Malignant Total 0/302(0%) 1/301(0.3%) Mean(sd) 0.0%(0.0) 0.3%(0.8) Range 0/52 - 0/52 0/51 - 1/50 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 1/50 --------------------------------------------------------------------------- =========================================================================== SEMINAL VESICLE FISCHER344 RATS DERMAL ETHANOL (Updated 12/99) Males(6 studies) Females(6 studies) =========================================================================== Adenoma Total 0/302(0%) Mean(sd) 0.0%(0.0) Range 0/52 - 0/52 Males 0/52 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- =========================================================================== SKELETAL MUSCLE FISCHER344 RATS DERMAL ETHANOL (Updated 12/99) Males(6 studies) Females(6 studies) =========================================================================== Fibrosarcoma Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Fibrous Histiocytoma Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Hemangiosarcoma Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Lipoma Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Rhabdomyosarcoma Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Rhabdomyosarcoma or Total 0/302(0%) 0/301(0%) Rhabdomyoma Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Sarcoma Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Schwannoma Malignant Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- =========================================================================== SKIN1: SEBACEOUS GLAND FISCHER344 RATS DERMAL ETHANOL (Updated 12/99) Males(6 studies) Females(6 studies) =========================================================================== Adenoma Total 3/302(1%) 0/301(0%) Mean(sd) 1.0%(1.7) 0.0%(0.0) Range 0/52 - 2/50 0/51 - 0/51 Males 0/52 2/50 0/50 1/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Carcinoma Total 2/302(0.7%) 0/301(0%) Mean(sd) 0.7%(1.0) 0.0%(0.0) Range 0/50 - 1/50 0/51 - 0/51 Males 1/52 0/50 1/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Carcinoma or Adenoma Total 5/302(1.7%) 0/301(0%) Mean(sd) 1.7%(1.5) 0.0%(0.0) Range 0/50 - 2/50 0/51 - 0/51 Males 1/52 2/50 1/50 1/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Squamous Cell Papilloma Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- =========================================================================== SKIN2 FISCHER344 RATS DERMAL ETHANOL (Updated 12/99) Males(6 studies) Females(6 studies) =========================================================================== Basal Cell Adenoma Total 2/302(0.7%) 0/301(0%) Mean(sd) 0.7%(1.0) 0.0%(0.0) Range 0/52 - 1/50 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 1/50 1/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Basal Cell Adenoma or Total 2/302(0.7%) 1/301(0.3%) Basosquamous Tumor Mean(sd) 0.7%(1.0) 0.3%(0.8) Benign Range 0/52 - 1/50 0/50 - 1/51 Males 0/52 0/50 0/50 0/50 1/50 1/50 Females 1/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Basal Cell Adenoma, Total 3/302(1%) 1/301(0.3%) Basosquamous Tumor Mean(sd) 1.0%(1.7) 0.3%(0.8) Benign, or Range 0/52 - 2/50 0/50 - 1/51 Trichoepithelioma Males 0/52 0/50 0/50 0/50 2/50 1/50 Females 1/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Basal Cell Carcinoma Total 2/302(0.7%) 0/301(0%) Mean(sd) 0.7%(1.6) 0.0%(0.0) Range 0/52 - 2/50 0/51 - 0/51 Males 0/52 0/50 0/50 2/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Basal Cell Carcinoma Total 2/302(0.7%) 0/301(0%) or Basosquamous Tumor Mean(sd) 0.7%(1.6) 0.0%(0.0) (malignant or NOS) Range 0/52 - 2/50 0/51 - 0/51 Males 0/52 0/50 0/50 2/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Basal Cell Carcinoma, Total 5/302(1.7%) 1/301(0.3%) Basal Cell Adenoma, Mean(sd) 1.7%(2.0) 0.3%(0.8) Basosquamous Tumor Range 0/52 - 2/50 0/50 - 1/51 (benign, malignant or NOS), or Trichoepithelioma Males 0/52 0/50 0/50 2/50 2/50 1/50 Females 1/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Basal or Sq. Cell Total 18/302(6%) 2/301(0.7%) Carcinoma, Carcinoma, Mean(sd) 6.0%(5.7) 0.7%(1.0) Basosq. Tumor (M or B), Range 0/50 - 7/50 0/50 - 1/51 Basal Cell Adenoma, Adenoma, Papilloma, Sq Papilloma, Keratoacanthoma, Trichoepithelioma Males 2/52 2/50 0/50 6/50 7/50 1/50 Females 1/51 0/50 1/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Basosquamous Tumor Total 0/302(0%) 1/301(0.3%) Benign Mean(sd) 0.0%(0.0) 0.3%(0.8) Range 0/52 - 0/52 0/50 - 1/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 1/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Basosquamous Tumor Total 0/302(0%) 0/301(0%) Malignant Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Hemangioma Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Hemangiopericytoma Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Hemangiosarcoma Total 1/302(0.3%) 0/301(0%) Mean(sd) 0.3%(0.8) 0.0%(0.0) Range 0/52 - 1/50 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 1/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Keratoacanthoma Total 12/302(4%) 0/301(0%) Mean(sd) 4.0%(3.6) 0.0%(0.0) Range 0/50 - 5/50 0/51 - 0/51 Males 1/52 2/50 0/50 3/50 5/50 1/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Lipoma Total 1/302(0.3%) 0/301(0%) Mean(sd) 0.3%(0.8) 0.0%(0.0) Range 0/52 - 1/50 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 1/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Liposarcoma Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Melanoma Benign Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Melanoma Malignant Total 1/302(0.3%) 2/301(0.7%) Mean(sd) 0.3%(0.8) 0.7%(1.0) Range 0/52 - 1/50 0/51 - 1/50 Males 0/52 0/50 1/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 1/50 0/50 1/50 --------------------------------------------------------------------------- Osteosarcoma Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Squamous Cell Carcinoma Total 1/302(0.3%) 0/301(0%) Mean(sd) 0.3%(0.8) 0.0%(0.0) Range 0/52 - 1/50 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 1/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Squamous Cell Total 3/302(1%) 0/301(0%) Carcinoma, Basal Cell Mean(sd) 1.0%(1.7) 0.0%(0.0) Carcinoma, Basosquamous Range 0/52 - 2/50 0/51 - 0/51 Tumor (malignant or NOS), or Carcinoma Males 0/52 0/50 0/50 2/50 1/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Squamous Cell Papilloma Total 2/302(0.7%) 1/301(0.3%) Mean(sd) 0.7%(1.0) 0.3%(0.8) Range 0/50 - 1/50 0/51 - 1/50 Males 1/52 0/50 0/50 1/50 0/50 0/50 Females 0/51 0/50 1/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Squamous Cell Total 2/302(0.7%) 1/301(0.3%) Papilloma or Papilloma Mean(sd) 0.7%(1.0) 0.3%(0.8) Range 0/50 - 1/50 0/51 - 1/50 Males 1/52 0/50 0/50 1/50 0/50 0/50 Females 0/51 0/50 1/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Squamous Cell Total 14/302(4.6%) 1/301(0.3%) Papilloma, Papilloma, Mean(sd) 4.6%(3.7) 0.3%(0.8) Squamous Cell Carcinoma Range 0/50 - 5/50 0/51 - 1/50 or Keratoacanthoma Males 2/52 2/50 0/50 4/50 5/50 1/50 Females 0/51 0/50 1/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Squamous Cell Total 14/302(4.6%) 1/301(0.3%) Papilloma, Papilloma, or Mean(sd) 4.6%(3.7) 0.3%(0.8) Keratoacanthoma Range 0/50 - 5/50 0/51 - 1/50 Males 2/52 2/50 0/50 4/50 5/50 1/50 Females 0/51 0/50 1/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Trichoepithelioma Total 1/302(0.3%) 0/301(0%) Mean(sd) 0.3%(0.8) 0.0%(0.0) Range 0/52 - 1/50 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 1/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- =========================================================================== SKIN3 FISCHER344 RATS DERMAL ETHANOL (Updated 12/99) Males(6 studies) Females(6 studies) =========================================================================== Fibroma Total 9/302(3%) 2/301(0.7%) Mean(sd) 3.0%(2.8) 0.7%(1.6) Range 0/52 - 3/50 0/51 - 2/50 Males 0/52 0/50 1/50 3/50 3/50 2/50 Females 0/51 0/50 0/50 0/50 2/50 0/50 --------------------------------------------------------------------------- Fibroma, Fibrosarcoma, Total 10/302(3.3%) 3/301(1%) Sarcoma, Myxoma, Mean(sd) 3.3%(3.3) 1.0%(1.7) Myxosarcoma, or Fibrous Range 0/52 - 4/50 0/51 - 2/50 Histiocytoma Males 0/52 0/50 1/50 3/50 4/50 2/50 Females 0/51 1/50 0/50 0/50 2/50 0/50 --------------------------------------------------------------------------- Fibrosarcoma Total 1/302(0.3%) 1/301(0.3%) Mean(sd) 0.3%(0.8) 0.3%(0.8) Range 0/52 - 1/50 0/51 - 1/50 Males 0/52 0/50 0/50 0/50 1/50 0/50 Females 0/51 1/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Fibrosarcoma, Sarcoma, Total 1/302(0.3%) 1/301(0.3%) Myxosarcoma, or Fibrous Mean(sd) 0.3%(0.8) 0.3%(0.8) Histiocytoma Range 0/52 - 1/50 0/51 - 1/50 Males 0/52 0/50 0/50 0/50 1/50 0/50 Females 0/51 1/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Fibrous Histiocytoma Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Neurofibroma Total 1/302(0.3%) 0/301(0%) Mean(sd) 0.3%(0.8) 0.0%(0.0) Range 0/50 - 1/52 0/51 - 0/51 Males 1/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Neurofibroma or Total 1/302(0.3%) 0/301(0%) Schwannoma benign Mean(sd) 0.3%(0.8) 0.0%(0.0) Range 0/50 - 1/52 0/51 - 0/51 Males 1/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Neurofibrosarcoma Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Neurofibrosarcoma or Total 0/302(0%) 1/301(0.3%) Schwannoma (malignant or Mean(sd) 0.0%(0.0) 0.3%(0.8) NOS) Range 0/52 - 0/52 0/51 - 1/50 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 1/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Neurofibrosarcoma, Total 1/302(0.3%) 1/301(0.3%) Neurofibroma, or Mean(sd) 0.3%(0.8) 0.3%(0.8) Schwannoma (benign, Range 0/50 - 1/52 0/51 - 1/50 malignant or NOS) Males 1/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 1/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Sarcoma Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Schwannoma Benign Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Schwannoma Malignant Total 0/302(0%) 1/301(0.3%) Mean(sd) 0.0%(0.0) 0.3%(0.8) Range 0/52 - 0/52 0/51 - 1/50 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 1/50 0/50 0/50 0/50 --------------------------------------------------------------------------- =========================================================================== SPINAL CORD FISCHER344 RATS DERMAL ETHANOL (Updated 12/99) Males(6 studies) Females(6 studies) =========================================================================== Astrocytoma Benign Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Astrocytoma Malignant Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Chordoma Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Glioma Benign Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- =========================================================================== SPLEEN FISCHER344 RATS DERMAL ETHANOL (Updated 12/99) Males(6 studies) Females(6 studies) =========================================================================== Fibroma Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Fibrosarcoma Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Hemangioma Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Hemangiosarcoma Total 1/302(0.3%) 1/301(0.3%) Mean(sd) 0.3%(0.8) 0.3%(0.8) Range 0/50 - 1/52 0/51 - 1/50 Males 1/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 1/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Leiomyosarcoma Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Osteosarcoma Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Sarcoma Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- =========================================================================== STOMACH, FORESTOMACH FISCHER344 RATS DERMAL ETHANOL (Updated 12/99) Males(6 studies) Females(6 studies) =========================================================================== Basal Cell Adenoma Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Leiomyosarcoma Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Squamous Cell Carcinoma Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Squamous Cell Total 3/302(1%) 0/301(0%) Carcinoma or Papilloma Mean(sd) 1.0%(2.4) 0.0%(0.0) Squamous Range 0/52 - 3/50 0/51 - 0/51 Males 0/52 0/50 0/50 3/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Squamous Cell Papilloma Total 3/302(1%) 0/301(0%) Mean(sd) 1.0%(2.4) 0.0%(0.0) Range 0/52 - 3/50 0/51 - 0/51 Males 0/52 0/50 0/50 3/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- =========================================================================== STOMACH, GLANDULAR FISCHER344 RATS DERMAL ETHANOL (Updated 12/99) Males(6 studies) Females(6 studies) =========================================================================== Carcinoid Tumor Benign Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Carcinoid Tumor Total 0/302(0%) 0/301(0%) Malignant Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Leiomyosarcoma Total 1/302(0.3%) 0/301(0%) Mean(sd) 0.3%(0.8) 0.0%(0.0) Range 0/52 - 1/50 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 1/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- =========================================================================== TESTES FISCHER344 RATS DERMAL ETHANOL (Updated 12/99) Males(6 studies) Females(6 studies) =========================================================================== Adenoma Total 165/302(54.6%) Mean(sd) 54.5%(15.2) Range 20/50 - 42/52 Males 42/52 32/50 24/50 23/50 20/50 24/50 --------------------------------------------------------------------------- =========================================================================== THYMUS FISCHER344 RATS DERMAL ETHANOL (Updated 12/99) Males(6 studies) Females(6 studies) =========================================================================== Sarcoma Total 0/273(0%) 0/282(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/44 - 0/44 0/46 - 0/46 Males 0/44 0/47 0/46 0/47 0/44 0/45 Females 0/46 0/49 0/49 0/47 0/44 0/47 --------------------------------------------------------------------------- Schwannoma Malignant Total 0/273(0%) 0/282(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/44 - 0/44 0/46 - 0/46 Males 0/44 0/47 0/46 0/47 0/44 0/45 Females 0/46 0/49 0/49 0/47 0/44 0/47 --------------------------------------------------------------------------- Thymoma Benign Total 0/273(0%) 0/282(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/44 - 0/44 0/46 - 0/46 Males 0/44 0/47 0/46 0/47 0/44 0/45 Females 0/46 0/49 0/49 0/47 0/44 0/47 --------------------------------------------------------------------------- Thymoma Malignant Total 0/273(0%) 0/282(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/44 - 0/44 0/46 - 0/46 Males 0/44 0/47 0/46 0/47 0/44 0/45 Females 0/46 0/49 0/49 0/47 0/44 0/47 --------------------------------------------------------------------------- Thymoma NOS Total 0/273(0%) 0/282(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/44 - 0/44 0/46 - 0/46 Males 0/44 0/47 0/46 0/47 0/44 0/45 Females 0/46 0/49 0/49 0/47 0/44 0/47 --------------------------------------------------------------------------- Thymoma: Benign, Total 0/273(0%) 0/282(0%) Malignant, NOS Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/44 - 0/44 0/46 - 0/46 Males 0/44 0/47 0/46 0/47 0/44 0/45 Females 0/46 0/49 0/49 0/47 0/44 0/47 --------------------------------------------------------------------------- =========================================================================== THYROID GLAND FISCHER344 RATS DERMAL ETHANOL (Updated 12/99) Males(6 studies) Females(6 studies) =========================================================================== Adenoma Total 0/301(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/51 - 0/51 0/51 - 0/51 Males 0/51 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- =========================================================================== THYROID GLAND: C-CELL FISCHER344 RATS DERMAL ETHANOL (Updated 12/99) Males(6 studies) Females(6 studies) =========================================================================== Adenoma Total 29/301(9.6%) 38/301(12.6%) Mean(sd) 9.6%(5.8) 12.6%(7.8) Range 2/50 - 9/50 1/50 - 11/51 Males 7/51 6/50 9/50 3/50 2/50 2/50 Females 11/51 8/50 10/50 4/50 1/50 4/50 --------------------------------------------------------------------------- Carcinoma Total 3/301(1%) 3/301(1%) Mean(sd) 1.0%(1.7) 1.0%(1.1) Range 0/51 - 2/50 0/50 - 1/51 Males 0/51 0/50 0/50 0/50 1/50 2/50 Females 1/51 0/50 0/50 1/50 1/50 0/50 --------------------------------------------------------------------------- Carcinoma or Adenoma Total 31/301(10.3%) 40/301(13.3%) Mean(sd) 10.3%(5.1) 13.3%(7.0) Range 3/50 - 9/50 2/50 - 11/51 Males 7/51 6/50 9/50 3/50 3/50 3/50 Females 11/51 8/50 10/50 5/50 2/50 4/50 --------------------------------------------------------------------------- =========================================================================== THYROID GLAND: FOLLICULAR CELL FISCHER344 RATS DERMAL ETHANOL (Updated 12/99) Males(6 studies) Females(6 studies) =========================================================================== Adenoma Total 2/301(0.7%) 4/301(1.3%) Mean(sd) 0.7%(1.0) 1.3%(1.6) Range 0/50 - 1/51 0/51 - 2/50 Males 1/51 1/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 1/50 2/50 1/50 0/50 --------------------------------------------------------------------------- Carcinoma Total 4/301(1.3%) 1/301(0.3%) Mean(sd) 1.3%(1.6) 0.3%(0.8) Range 0/51 - 2/50 0/51 - 1/50 Males 0/51 1/50 1/50 2/50 0/50 0/50 Females 0/51 0/50 0/50 1/50 0/50 0/50 --------------------------------------------------------------------------- Carcinoma or Adenoma Total 6/301(2%) 5/301(1.7%) Mean(sd) 2.0%(1.8) 1.7%(2.3) Range 0/50 - 2/50 0/51 - 3/50 Males 1/51 2/50 1/50 2/50 0/50 0/50 Females 0/51 0/50 1/50 3/50 1/50 0/50 --------------------------------------------------------------------------- =========================================================================== TISSUE NOS FISCHER344 RATS DERMAL ETHANOL (Updated 12/99) Males(6 studies) Females(6 studies) =========================================================================== Carcinoma Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Chemodectoma Malignant Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Fibroma Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Fibrosarcoma Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Fibrous Histiocytoma Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Hemangiosarcoma Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Osteosarcoma Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Paraganglioma Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Sarcoma Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Schwannoma Malignant Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Squamous Cell Carcinoma Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Yolk Sac Carcinoma Total 1/302(0.3%) 0/301(0%) Mean(sd) 0.3%(0.8) 0.0%(0.0) Range 0/52 - 1/50 0/51 - 0/51 Males 0/52 1/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- =========================================================================== TONGUE FISCHER344 RATS DERMAL ETHANOL (Updated 12/99) Males(6 studies) Females(6 studies) =========================================================================== Carcinoma Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Squamous Cell Carcinoma Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Squamous Cell Total 1/302(0.3%) 0/301(0%) Carcinoma or Papilloma Mean(sd) 0.3%(0.8) 0.0%(0.0) Squamous Range 0/52 - 1/50 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 1/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Squamous Cell Papilloma Total 1/302(0.3%) 0/301(0%) Mean(sd) 0.3%(0.8) 0.0%(0.0) Range 0/52 - 1/50 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 1/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- =========================================================================== TOOTH FISCHER344 RATS DERMAL ETHANOL (Updated 12/99) Males(6 studies) Females(6 studies) =========================================================================== Adamantinoma Benign Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Adamantinoma Malignant Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Fibrosarcoma Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Odontoma Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Squamous Cell Carcinoma Total 1/302(0.3%) 0/301(0%) Mean(sd) 0.3%(0.8) 0.0%(0.0) Range 0/50 - 1/52 0/51 - 0/51 Males 1/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- =========================================================================== URETHRA FISCHER344 RATS DERMAL ETHANOL (Updated 12/99) Males(6 studies) Females(6 studies) =========================================================================== Carcinoma Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- =========================================================================== URINARY BLADDER FISCHER344 RATS DERMAL ETHANOL (Updated 12/99) Males(6 studies) Females(6 studies) =========================================================================== Carcinoma Total 0/299(0%) 1/300(0.3%) Mean(sd) 0.0%(0.0) 0.3%(0.8) Range 0/52 - 0/52 0/51 - 1/49 Males 0/52 0/48 0/50 0/50 0/50 0/49 Females 0/51 0/50 0/50 0/50 1/49 0/50 --------------------------------------------------------------------------- Carcinoma or Papilloma Total 2/299(0.7%) 2/300(0.7%) Mean(sd) 0.7%(1.0) 0.7%(1.0) Range 0/52 - 1/50 0/51 - 1/50 Males 0/52 0/48 1/50 0/50 0/50 1/49 Females 0/51 0/50 0/50 1/50 1/49 0/50 --------------------------------------------------------------------------- Leiomyoma Total 0/299(0%) 0/300(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/48 0/50 0/50 0/50 0/49 Females 0/51 0/50 0/50 0/50 0/49 0/50 --------------------------------------------------------------------------- Leiomyosarcoma Total 0/299(0%) 0/300(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/48 0/50 0/50 0/50 0/49 Females 0/51 0/50 0/50 0/50 0/49 0/50 --------------------------------------------------------------------------- Papilloma Total 2/299(0.7%) 1/300(0.3%) Mean(sd) 0.7%(1.0) 0.3%(0.8) Range 0/52 - 1/50 0/51 - 1/50 Males 0/52 0/48 1/50 0/50 0/50 1/49 Females 0/51 0/50 0/50 1/50 0/49 0/50 --------------------------------------------------------------------------- =========================================================================== UTERUS FISCHER344 RATS DERMAL ETHANOL (Updated 12/99) Males(6 studies) Females(6 studies) =========================================================================== Adenoma Total 1/301(0.3%) Mean(sd) 0.3%(0.8) Range 0/51 - 1/50 Females 0/51 0/50 0/50 0/50 0/50 1/50 --------------------------------------------------------------------------- Carcinoma Total 0/301(0%) Mean(sd) 0.0%(0.0) Range 0/51 - 0/51 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Deciduoma Benign Total 0/301(0%) Mean(sd) 0.0%(0.0) Range 0/51 - 0/51 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Deciduoma NOS Total 0/301(0%) Mean(sd) 0.0%(0.0) Range 0/51 - 0/51 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Fibroma Total 1/301(0.3%) Mean(sd) 0.3%(0.8) Range 0/51 - 1/50 Females 0/51 0/50 1/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Fibrosarcoma Total 0/301(0%) Mean(sd) 0.0%(0.0) Range 0/51 - 0/51 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Granular Cell Tumor Total 0/301(0%) Malignant Mean(sd) 0.0%(0.0) Range 0/51 - 0/51 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Hemangioma Total 0/301(0%) Mean(sd) 0.0%(0.0) Range 0/51 - 0/51 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Hemangiosarcoma Total 0/301(0%) Mean(sd) 0.0%(0.0) Range 0/51 - 0/51 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Leiomyoma Total 0/301(0%) Mean(sd) 0.0%(0.0) Range 0/51 - 0/51 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Leiomyosarcoma Total 0/301(0%) Mean(sd) 0.0%(0.0) Range 0/51 - 0/51 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Polyp Stromal Total 17/301(5.6%) Mean(sd) 5.7%(3.4) Range 1/50 - 6/50 Females 3/51 3/50 2/50 6/50 2/50 1/50 --------------------------------------------------------------------------- Sarcoma Total 0/301(0%) Mean(sd) 0.0%(0.0) Range 0/51 - 0/51 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Sarcoma Stromal Total 1/301(0.3%) Mean(sd) 0.3%(0.8) Range 0/51 - 1/50 Females 0/51 1/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Sarcoma Stromal or Total 18/301(6%) Polyp Stromal Mean(sd) 6.0%(3.6) Range 1/50 - 6/50 Females 3/51 4/50 2/50 6/50 2/50 1/50 --------------------------------------------------------------------------- Schwannoma Malignant Total 0/301(0%) Mean(sd) 0.0%(0.0) Range 0/51 - 0/51 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Schwannoma NOS Total 0/301(0%) Mean(sd) 0.0%(0.0) Range 0/51 - 0/51 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Squamous Cell Carcinoma Total 0/301(0%) Mean(sd) 0.0%(0.0) Range 0/51 - 0/51 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- =========================================================================== VAGINA FISCHER344 RATS DERMAL ETHANOL (Updated 12/99) Males(6 studies) Females(6 studies) =========================================================================== Fibrosarcoma Total 0/301(0%) Mean(sd) 0.0%(0.0) Range 0/51 - 0/51 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Leiomyosarcoma Total 0/301(0%) Mean(sd) 0.0%(0.0) Range 0/51 - 0/51 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Polyp Total 0/301(0%) Mean(sd) 0.0%(0.0) Range 0/51 - 0/51 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Sarcoma Total 0/301(0%) Mean(sd) 0.0%(0.0) Range 0/51 - 0/51 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Schwannoma Malignant Total 0/301(0%) Mean(sd) 0.0%(0.0) Range 0/51 - 0/51 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- =========================================================================== ZYMBAL'S GLAND FISCHER344 RATS DERMAL ETHANOL (Updated 12/99) Males(6 studies) Females(6 studies) =========================================================================== Adenoma Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Carcinoma Total 4/302(1.3%) 2/301(0.7%) Mean(sd) 1.3%(1.6) 0.7%(1.6) Range 0/50 - 2/52 0/51 - 2/50 Males 2/52 0/50 0/50 1/50 0/50 1/50 Females 0/51 2/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Carcinoma or Adenoma Total 4/302(1.3%) 2/301(0.7%) Mean(sd) 1.3%(1.6) 0.7%(1.6) Range 0/50 - 2/52 0/51 - 2/50 Males 2/52 0/50 0/50 1/50 0/50 1/50 Females 0/51 2/50 0/50 0/50 0/50 0/50 --------------------------------------------------------------------------- Squamous Cell Papilloma Total 0/302(0%) 0/301(0%) Mean(sd) 0.0%(0.0) 0.0%(0.0) Range 0/52 - 0/52 0/51 - 0/51 Males 0/52 0/50 0/50 0/50 0/50 0/50 Females 0/51 0/50 0/50 0/50 0/50 0/50 ---------------------------------------------------------------------------