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Title: An approach for integrating toxicogenomic data in risk assessment: The dibutyl phthalate case study

An approach for evaluating and integrating genomic data in chemical risk assessment was developed based on the lessons learned from performing a case study for the chemical dibutyl phthalate. A case study prototype approach was first developed in accordance with EPA guidance and recommendations of the scientific community. Dibutyl phthalate (DBP) was selected for the case study exercise. The scoping phase of the dibutyl phthalate case study was conducted by considering the available DBP genomic data, taken together with the entire data set, for whether they could inform various risk assessment aspects, such as toxicodynamics, toxicokinetics, and dose–response. A description of weighing the available dibutyl phthalate data set for utility in risk assessment provides an example for considering genomic data for future chemical assessments. As a result of conducting the scoping process, two questions—Do the DBP toxicogenomic data inform 1) the mechanisms or modes of action?, and 2) the interspecies differences in toxicodynamics?—were selected to focus the case study exercise. Principles of the general approach include considering the genomics data in conjunction with all other data to determine their ability to inform the various qualitative and/or quantitative aspects of risk assessment, and evaluating the relationship between the available genomic andmore » toxicity outcome data with respect to study comparability and phenotypic anchoring. Based on experience from the DBP case study, recommendations and a general approach for integrating genomic data in chemical assessment were developed to advance the broader effort to utilize 21st century data in risk assessment. - Highlights: • Performed DBP case study for integrating genomic data in risk assessment • Present approach for considering genomic data in chemical risk assessment • Present recommendations for use of genomic data in chemical risk assessment.« less
Authors:
 [1] ;  [2] ;  [1] ;  [3]
  1. National Center for Environmental Assessment, Office of Research and Development, U.S. Environmental Protection Agency, Washington, DC (United States)
  2. ToxStrategies, Inc., 23501 Cinco Ranch Blvd., Suite G265, Katy, TX 77494 (United States)
  3. U.S. Environmental Protection Agency, Region 8, Mail code 8P-W, 1595 Wynkoop Street, Denver, CO 80202 (United States)
Publication Date:
OSTI Identifier:
22285382
Resource Type:
Journal Article
Resource Relation:
Journal Name: Toxicology and Applied Pharmacology; Journal Volume: 271; Journal Issue: 3; Other Information: Copyright (c) 2013 Elsevier Science B.V., Amsterdam, The Netherlands, All rights reserved.; Country of input: International Atomic Energy Agency (IAEA)
Country of Publication:
United States
Language:
English
Subject:
60 APPLIED LIFE SCIENCES; ABSORPTION; ALDEHYDES; DBP; EXCRETION; HAZARDS; INSULIN; METABOLISM; POLYPEPTIDES; RECEPTORS; RECOMMENDATIONS; RISK ASSESSMENT; TESTOSTERONE; TOXICITY; US EPA