Record Display for the EPA National Library Catalog


OLS Field Name OLS Field Data
Main Title Recommended Use of Body Weight(3/4) as the Default Method in Derivation of the Oral Reference Dose.
CORP Author Environmental Protection Agency, Washington, DC. Risk Assessment Forum.
Year Published 2010
Report Number EPA/100/R11/0001
Stock Number PB2011-112921
Additional Subjects Toxicity ; Oral dosage ; Body weight ; Cancer ; Oral ; Dosimetry ; Default method ; Animal models ; Humans ; Exposure ; Physiology ; Scaling factor ; Laboratory tests ; Risk assessment ; Guidelines
Library Call Number Additional Info Location Last
NTIS  PB2011-112921 Most EPA libraries have a fiche copy filed under the call number shown. Check with individual libraries about paper copy. NTIS 03/09/2012
Collation 50p
This document is a product of efforts by the Agency to develop and promote biologically based and harmonized approaches for all toxicological endpoints used in human health risk assessments. EPA risk assessors routinely use body weight (BW) as the basis for scaling toxicity data from animal models for human health risk assessments. However, the Agency has used BW(1/1) for non-cancer endpoints and, at various times BW(2/3) or BW(3/4) for cancer endpoints to normalize dose across species. This document promotes the use of BW(3/4) as a default method to convert data between species for both categories of endpoints. A hierarchy of methods for interspecies scaling is presented along with the rationale for selection of the scaling factor and guidance on how to conduct the conversion. EPA endorses a hierarchy of approaches to derive human equivalent oral exposures from data from laboratory animal species, with the preferred approach being physiologically-based toxicokinetic modeling.