62
Views
26
CrossRef citations to date
0
Altmetric
Original Articles

Review of noncancer risk assessment: Applications of benchmark dose methods

&
Pages 893-920 | Published online: 02 Dec 2008

References

  • Allen , B.C. , Kavlock , R.J. , Kimmel , C.A. and Faustman , E.M. 1994a . Dose‐response assessment for developmental toxicity. II. Comparison of generic benchmark dose estimates with no observed adverse effect levels . Fundam Appl Toxicol , 23 (4) : 487 – 95 .
  • Allen , B.C. , Kavlock , R.J. , Kimmel , C.A. and Faustman , E.M. 1994b . Dose‐response assessment for developmental toxicity. III. Statistical models . Fundam Appl Toxicol , 23 (4) : 496 – 509 .
  • Allen , B.C. , Strong , P.L. , Price , C.J. , Hubbard , S.A. and Daston , G.P. 1996 . Benchmark dose analysis of developmental toxicity in rats exposed to boric acid . Fundam Appl Toxicol , 32 (2) : 194 – 204 .
  • Auton , T.R. 1994 . Calculation of benchmark doses from teratology data . Regul Toxicol Pharmacol , 19 (2) : 152 – 67 .
  • Bailer , A.J. and Oris , J.T. 1993 . Modeling reproductive toxicity in ceriodaphnia tests . Environ Toxicol Chem , 12 : 787 – 791 .
  • Bailer , A.J. and Oris , J.T. 1994 . “ Assessing toxicity of pollutants in aquatic systems ” . In Case Studies in Biometry , 296 – 306 . New York : John Wiley & Sons, Inc. .
  • Barnes , D.G. , Daston , G.P. , Evans , J.S. , Jarabek , A.M. , Kavlock , R.J. , Kimmel , C.A. , Park , C. and Spitzer , H.L. 1995 . Benchmark Dose Workshop: criteria for use of a benchmark dose to estimate a reference dose . Regul Toxicol Pharmacol , 21 (2) : 296 – 306 .
  • Beck , B.B. , Conolly , R.B. , Dourson , M.L. , Guth , D. , Hattis , D. , Kimmel , C. and Lewis , S.C. 1993 . Sumposium overview—Improvements in quantitative noncancer risk assessment . Fundam Appl Toxicol , 20 : 478 – 509 .
  • Catalano , P. , Ryan , L. and Scharfstein , D. 1994 . Modeling fetal death and malformation in developmental toxicity studies . Risk Anal , 14 (4) : 629 – 37 .
  • CDC (U.S. Centers for Disease Control and Prevention) . 1990 . Years of potential life lost before ages 65 and 85—United States, 1987 and 1988 . MMWR , 14 : 595 – 604 .
  • CDC . 1995 . Economic costs of birth defects and crebral palsy—United States, 1992 . MMWR , 44 : 694 – 695 .
  • Chen , J. , Kodell , R. , Howe , R. and Gaylor , D. 1991 . Analysis of trinomial responses from reproductive and developmental toxicology experiments . Biometrics , 47 : 1049 – 58 .
  • Clewell , H.J. , Gearhart , J.M. , Covington , T.R. and Gentry , P.R. February 9 1996 . Investigation of the potential impact of benchmark dose and pharmacokinetic modeling on minimal risk levels , February 9 , Ruston , LA : ATSDR . 1996.
  • Crump , K.S. 1984 . A new method for determining allowable daily intakes . Fundam Appl Toxicol , 4 (5) : 854 – 71 .
  • Crump , K . 1995 . Calculation of benchmark doses from continuous data . Risk Anal , 15 : 79 – 85 .
  • Crump , K. , Allen , B. , Faustman , E. , Donison , M. , Kimmel , C and Zenich , H. 1995 . The use of the benchmark dose approach in health risk assessment , Risk Assessment Forum . EPA/630/R‐94/007. February, 1995.
  • Faustman , E.M. , Allen , B.C. , Kavlock , R.J. and Kimmel , C.A. 1994 . Dose‐response assessment for developmental toxicity. I. Characterization of database and determination of no observed adverse effect levels . Fundam Appl Toxicol , 23 (4) : 478 – 86 .
  • Faustman , E.M. and Omenn , G.S. 1995 . “ Risk assessment ” . In Cassarett and Coull's Toxicology: The basic science of poisons, , 5th ed. , Edited by: Klaassen , C. 75 – 88 . New York : McGraw‐Hill, Inc. .
  • Foster , P.M. and Auton , T.R. 1995 . Application of benchmark dose risk assessment methodology to developmental toxicity: an industrial view . Toxicol Lett , 83 : 555 – 559 .
  • Gaylor , D.W. and Slikker , W. 1990 . Risk assessment for neurotoxic effects . Neurotoxicol , 11 : 211
  • Gaylor , D.W. 1992 . Incidence of developmental defects at the no observed adverse effect level (NOAEL) . Regal Toxicol Pharmacol , 15 (2 Pt 1) : 151 – 60 .
  • Gaylor , D. and Razzaghi , M. 1992 . Process of building biologically based dose response models for developmental defects . Teratol , 46 : 573 – 581 .
  • Gaylor , D.W. and Chen , J.J. 1996 . Precision of benchmark dose estimates for continuous (nonquantal) measurements of toxic effects . Regul Toxicol Pharmacol , 24 (1 part 1) : 19 – 23 .
  • Gearhart , J.M. , Clewell , I.H.J. , Crump , K. , Shipp , A. and Silvers , A. 1995 . Pharmacokinetic dose estimates of mercury in children and dose‐response curves of performance tests in a large epidemiological study . Water Air Soil Pollut , 80 : 49 – 58 .
  • Haag‐Grönlund , M. , Fransson Steen , R. and Victorin , K. 1995 . Application of the benchmark method to risk assessment of trichloroethene . Regul Toxicol Pharmacol , 21 (2) : 261 – 9 .
  • Kavlock , R.J. , Allen , B.C. , Faustman , E.M. and Kimmel , C.A. 1995 . Dose‐response assessments for developmental toxicity. IV. Benchmark doses for fetal weight changes . Fundam Appl Toxicol , 26 (2) : 211 – 22 .
  • Kavlock , R.J. , Schmid , J.E. and Setzer , R.W. Jr. 1996 . A simulation study of the influence of study design on the estimation of benchmark doses for developmental toxicity . Risk Anal , 16 (3) : 399 – 410 .
  • Kavlock , R.J. 1997 . Recent advances in mathematical modeling of developmental abnormalities using mechanistic formation . Repro Toxicol , 11 : 423 – 434 .
  • Kimmel , C. and Gaylor , D. 1988 . Issues in qualitative and quantitative risk assessment for developmental toxicology . Risk Anal , 8 : 15 – 20 .
  • Kodell , R.L. , Howe , R.B. , Chen , J.J. and Gaylor , D.W. 1991 . Mathematical modeling of reproductive and developmental toxic effects for quantitative risk assessment . Risk Anal , 11 : 587 – 590 .
  • Kodell , R.L. , Chen , J.J. and Gaylor , D.W. 1995 . Neurotoxicity modeling for risk assessment . Regul Toxicol Pharmacol , 22 (1) : 24 – 9 .
  • Koëter , H.B.W.M. 1997 . Testing and risk assessment strategies: international perspectives . Repro Toxicol , 11 (2/3) : 453 – 456 .
  • Krewski , D. and Zhu , Y. 1994 . Applications of multinomial dose‐response models in developmental toxicity risk assessment . Risk Anal , 14 : 613 – 27 .
  • Krewski , D. and Zhu , Y. 1995 . A simple data trasformation for estimating benchmark doses in developmental toxicity experiments . Risk Anal , 15 : 29 – 39 .
  • Kupper , L. , Portier , C. , Hogan , M. and Yamamoto , E. 1986 . The impact of litter effects on dose‐response modeling in teratology . Biometrics , 42 : 85 – 98 .
  • Leroux , B. , Leisenring , W. , Mookgavkar , S. and Faustman , E.M. 1994 . A biologically based dose‐response model for developmental toxicology . Risk Anal , 16 : 449 – 458 .
  • Mattison , D.R. and Sandier , J.D. 1994 . Summary of the workshop on issues in risk assessment: quantitative methods for developmental toxicology . Risk Anal , 14 (4) : 595 – 604 .
  • NRC (National Research Council) . 1994 . Science and judgment in risk assessment , Washington, DC : National Academy Press .
  • Oris , J.T. and Bailer , A.J. 1993 . Statistical analysis of the ceriodaphnia toxicity test: sample size determination for reproductive effects . Environ Toxicol Chem , 12 : 85
  • Pease , W. , Vandenberg , J. and Hooper , K. 1991 . Comparing alternative approaches to establishing regulatory levels for reproductive toxicants: DBCP as a case study . Environ Health Perspect , 91 : 141 – 55 .
  • Rai , K. and Van Ryzin , J. 1985 . A dose response model for teratological experiments involving quantal responses . Biometrics , 41 : 1 – 9 .
  • Ryan , L. 1992 . The use of generalized estimating equations for risk assessment in developmental toxicity . Risk Anal , 12 : 439 – 447 .
  • Setzer , R.W. 1993 . Development of biologically based dose response models: modeling the effects of 5‐FU on cell cycle kinetics . Teratol , 47 : 435 – 436 .
  • Setzer , R.W. 1994 . Development of biologically based dose response models: using a mechanistic model to generate experimentally testable hypotheses about mechanisms of developmental toxicity of 5‐FU . Teratol , 49 : 396 – 397 .
  • Shuey , D.L. , Lau , C. , Logsdon , T.A. , Zucker , R. , Elstein , K. , Narotsky , N. , Setzer , W. , Kavlock , R.J. and Rogers , J.M. 1994 . Biologically based dose‐response models for developmental toxicology: biochemical and cellular sequelae of 5‐fluorouracil exposure in the developing rat . Toxicol Appl Pharmacol , 126 : 129 – 144 .
  • Slob , W. and Pieters , M.N. Probabilistic approach to assess human RfDs and human health risks from toxicological animal studies . Paper presented at the Annual Meeting of the Society for Risk Analysis . December 3–6 1995 , Waikiki , Hawaii .
  • Sullivan , F.M. 1995 . Regulatory and political perspectives in reproductive and developmental hazard assessment . Toxicol. Lett. , 83 : 533 – 537 .
  • USEPA (U.S. Environmental Protection Agency) . 1991 . Guidelines for developmental toxicity risk assessment . Federal Register , 56 : 63798 – 63826 .
  • USEPA (U.S. Environmental Protection Agency) . 1995 . Proposed guidelines for neurotox‐icity risk assessment . Federal Register , 60 : 52031 – 52056 .
  • Zhu , Y. , Krewski , D. and Ross , W.H. 1994 . Dose‐response models for correlated multinomial data from developmental toxicity studies . Appl Stat , 43 : 583 – 598 .
  • Correspondence Address: Institute for Risk Analysis and Risk Communication, Department of Environmental Health, School of Public Health and Community Medicine, University of Washington, 4225 Roosevelt Way NE, Suite 100, Seattle, WA 98105–6099; Tel: (206) 685–2269; Fax: (206) 685–4696; email: [email protected] This research was supported with funding from National Institute of Environmental Health Sciences UW Center Grant #P30‐ES07033 and from Department of Energy Cooperative Agreement #DE‐FCOl‐95EW55084. Special thanks to the President's Risk Commission and Chair Gilbert Omenn for their encouragement and financial support of the white paper on benchmark doses that formed the basis of this article.

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.