Studies/Chronic: Data Formats for Chronic/Oncogenicity Rodent Bioassays

摘要

The document presents the electronic data submission formats for parameters in a chronic/oncogenicity bioassay. The purpose of the document is to present file formats for the electronic transfer of individual animal toxicological data generated from long-term rodent chronic/oncogenicity studies. These formats have been developed to meet the electronic data submission requirements of the United States Environmental Protection Agency (EPA), the Department of Health and Human Services' Food and Drug Administration (FDA), the National Center for Toxicological Research (NCTR) and the Consumer Product Safety Commission (CPSC). It is intended that these formats be available for all electronic transfer of toxicological data between the chemical industry and the government, within the chemical industry itself and between government agencies.