Standardizing benchmark dose calculations to improve science-based decisions in human health assessments

Environmental Health Perspectives

Volumn 122, Issue 5, 2014, Pages 499-505

  Wignall, Jessica A ^a   Shapiro, Andrew J ^a   Wright, Fred A ^b   Woodruff, Tracey J ^c   Chiu, Weihsueh A ^d   Guyton, Kathryn Z ^d   Rusyn, Ivan ^a  

^a University of North Carolina at Chapel Hill   (United States)

^b UNIVERSITY OF NORTH CAROLINA   (United States)

^c Department of Medicine   (United States)

^d U S ENVIRONMENTAL PROTECTION AGENCY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ENVIRONMENTAL CHEMICAL;

ARTICLE; BENCHMARK DOSE CALCULATION; BODY WEIGHT; DECISION MAKING; DOSE CALCULATION; DOSE RESPONSE; DRUG SURVEILLANCE PROGRAM; HEALTH ASSESSMENT QUESTIONNAIRE; HEALTH HAZARD; HUMAN; PRIORITY JOURNAL; PUBLIC HEALTH; RELIABILITY; QUALITY CONTROL; RISK ASSESSMENT; THEORETICAL MODEL;

BENCHMARKING; DOSE-RESPONSE RELATIONSHIP, DRUG; HUMANS; MODELS, THEORETICAL; NO-OBSERVED-ADVERSE-EFFECT LEVEL; RISK ASSESSMENT;

EID: 84899752905     PISSN: 00916765     EISSN: 15529924     Source Type: Journal    
DOI: 10.1289/ehp.1307539     Document Type: Article

References (33)

1. Agency for Toxic Substances and Disease Registry. 2013. Minimal Risk Levels (MRLs). Available: http://www.atsdr. cdc.gov/mrls/index.asp [accessed 1 November 2013].
2. Allen B. C, Kavlock RJ, Kimmel CA, Faustman EM. 1994a. Dose-response assessment for developmental toxicity. II. Comparison of generic benchmark dose estimates with no observed adverse effect levels. Fundam Appl Toxicol 23:487-495.
3. Allen B. C, Kavlock RJ, Kimmel CA, Faustman EM. 1994b. Dose-response assessment for developmental toxicity. III. Statistical models. Fundam Appl Toxicol 23:496-509.
4. Barnes D. G, Dourson M. 1988. Reference dose (RfD): description and use in health risk assessments. Regul Toxicol Pharmacol 8:471-486.
5. Berthold M. R, Cebron N, Dill F, Gabriel TR, Kötter T, Meinl T, et al. 2007. KNIME: the Konstanz Information Miner. In: Studies in Classification, Data Analysis, and Knowledge Organization (GfKL 2007). Heidelberg-Berlin:Springer-Verlag.
6. Crump K.S. 1984. A new method for determining allowable daily intakes. Fundam Appl Toxicol 4:854-871.
7. Crump K.S. 1995. Calculation of benchmark doses from continuous data. Risk Anal 15:79-89.
8. Davis J. A, Gift JS, Zhao QJ. 2011. Introduction to benchmark dose methods and U.S. EPA's benchmark dose software (BMDS) version 2.1.1. Toxicol Appl Pharmacol 254:181-191.
9. Fourches D., Muratov E, Tropsha A. 2010. Trust, but verify: on the importance of chemical structure curation in cheminformatics and QSAR modeling research. J Chem Inf Model 50:1189-1204.
10. ICF International. 2012. BMDS Wizard: Installation and User's Guide. Durham, NC.
11. Melnick R. L, Thayer KA, Bucher JR. 2008. Conflicting views on chemical carcinogenesis arising from the design and evaluation of rodent carcinogenicity studies. Environ Health Perspect 116:130-135; doi:10.1289/ehp.9989.
12. NRC (National Research Council). 1983. Risk Assessment in the Federal Government: Managing the Process. Washington, DC:National Academies Press. Available: http://www.nap. edu/openbook.php?isbn=0309033497 [accessed 7 April 2014].
13. NRC (National Research Council). 2009. Science and Decisions: Advancing Risk Assessment. Washington, DC:National Academies Press. Available: http://www.nap.edu/ openbook.php?record_id=12209&page=1 [accessed 7 April 2014].
14. Office of Environmental Health Hazard Assessment. 2009a. California EPA OEHHA Cancer Potency Values as of July 21, 2009. Available: http://www.oehha.ca.gov/risk/pdf/ tcdb072109alpha.pdf [accessed 1 November 2013].
15. Office of Environmental Health Hazard Assessment. 2009b. Appendix A: Hot Spots Unit Risk and Cancer Potency Values. Available: http://www.oehha.ca.gov/air/hot_ spots/2009/AppendixA.pdf [accessed 1 November 2013].
16. Sand S., Portier CJ, Krewski D. 2011. A signal-to-noise crossover dose as the point of departure for health risk assessment. Environ Health Perspect 119:1766-1774; doi:10.1289/ ehp.1003327.
17. Sand S., Ringblom J, Hakansson H, Oberg M. 2012. The point of transition on the dose-effect curve as a reference point in the evaluation of in vitro toxicity data. J Appl Toxicol 32(10):843-849.
18. Sand S., Victorin K, Filipsson AF. 2008. The current state of knowledge on the use of the benchmark dose concept in risk assessment. J Appl Toxicol 28:405-421.
19. Shapiro A. 2013. Health Assessment Workspace Collaborative (HAWC). Available: https://hawcproject.org/ [accessed 1 November 2013].
20. Sirenko O., Cromwell EF, Crittenden C, Wignall JA, Wright FA, Rusyn I. 2013. Assessment of beating parameters in human induced pluripotent stem cells enables quantitative in vitro screening for cardiotoxicity. Toxicol Appl Pharmacol 273:500-507.
21. Slob W., Moerbeek M, Rauniomaa E, Piersma AH. 2005. A statistical evaluation of toxicity study designs for the estimation of the benchmark dose in continuous endpoints. Toxicol Sci 84(1):167-185.
22. Travis K. Z, Pate I, Welsh ZK. 2005. The role of the benchmark dose in a regulatory context. Regul Toxicol Pharmacol 43:280-291.
23. U.S. EPA (U.S. Environmental Protection Agency). 1993. Integrated Risk Information System (IRIS): Nitroguanidine (CASRN 556-88-7). Available: http://www.epa.gov/iris/ subst/0402.htm [accessed 1 November 2013].
24. U.S. EPA (U.S. Environmental Protection Agency). 2011a. Health Effects Assessment Summary Tables (HEAST) for Superfund. Available: http://epa-heast.ornl.gov/ [accessed 1 November 2013].
25. U.S. EPA (U.S. Environmental Protection Agency). 2011b. Toxicological Review of Dichloromethane (Methylene Chloride) (CAS No. 75-09-2): In Support of Summary Information on the Integrated Risk Information System (IRIS). EPA/635/R-10/003F. Washington, DC:U.S. EPA. Available: http://www.epa.gov/iris/toxreviews/0070tr.pdf [accessed 7 April 2014].
26. U.S. EPA (U.S. Environmental Protection Agency). 2011c. Toxicological Review of Trichloroethylene (CAS No. 79-01-6): In Support of Summary Information on the Integrated Risk Information System (IRIS). EPA/635/R-09/011F. Washington, DC:U.S. EPA. Available: http://www. epa.gov/iris/toxreviews/0199tr/0199tr.pdf [accessed 7 April 2014].
27. U.S. EPA (U.S. Environmental Protection Agency). 2012a. Benchmark Dose Technical Guidance. Washington, DC:U.S. EPA. Available: http://www.epa.gov/raf/ publications/pdfs/benchmark_dose_guidance.pdf [accessed 7 April 2014].
28. U.S. EPA (U.S. Environmental Protection Agency). 2012b. Step 2-Dose-Response Assessment. Available: http:// www.epa.gov/risk_assessment/dose-response.htm [accessed 1 April 2013].
29. U.S. EPA (U.S. Environmental Protection Agency). 2013a. U.S. Environmental Protection Agency Integrated Risk Information System (IRIS) Homepage. Available: http:// www.epa.gov/iris/ [accessed 1 November 2013].
30. U.S. EPA (U.S. Environmental Protection Agency). 2013b. Pesticides: Human Health Benchmarks for Pesticides. Available: http://iaspub.epa.gov/apex/pesticides/ f?p=HHBP:home [accessed 1 November 2013].
31. U.S. EPA (U.S. Environmental Protection Agency). 2013c. Provisional Peer Reviewed Toxicity Values for Superfund (PPRTV). PPRTV Assessments Electronic Library. Available: http://hhpprtv.ornl.gov/ [accessed 1 November 2013].
32. U.S. EPA (U.S. Environmental Protection Agency). 2013d. Pacific Southwest, Region 9: Regional Screening Levels (Formerly PRGs). Available: http://www.epa.gov/region9/ superfund/prg/ [accessed 1 November 2013].
33. Weininger D., Weininger A, Weininger JL. 1989. Smiles. 2. Algorithm for generation of unique smiles notation. J Chem Inf Comput Sci 29:97-101.