Procedures for calculating benchmark doses for health risk assessment

Regulatory Toxicology and Pharmacology

Volumn 28, Issue 2, 1998, Pages 150-164

  Gaylor, David ^a   Ryan, Louise ^b   Krewski, Dan ^c   Zhu, Yiliang ^d  

^a NATIONAL CENTER FOR TOXICOLOGICAL RESEARCH   (United States)

^b HARVARD SCHOOL OF PUBLIC HEALTH   (United States)

^c CARLETON UNIVERSITY   (Canada)

^d UNIVERSITY OF SOUTH FLORIDA   (United States)

Author keywords

Benchmark dose; Clustered data; Continuous data; Quantal data; Risk assessment

Indexed keywords

ANALYTIC METHOD; ANIMAL EXPERIMENT; ARTICLE; BODY HEIGHT; BODY WEIGHT; CORRELATION FUNCTION; DOSE CALCULATION; ENVIRONMENTAL EXPOSURE; FEMALE; FETUS GROWTH; FETUS WEIGHT; HEALTH HAZARD; NONHUMAN; PRIORITY JOURNAL; RISK ASSESSMENT; TERATOGENESIS; TOXICOLOGICAL PARAMETERS;

ANIMALIA;

EID: 0032452127     PISSN: 02732300     EISSN: None     Source Type: Journal    
DOI: 10.1006/rtph.1998.1247     Document Type: Article

References (62)

1. Allen B. C., Kavlock R. J., Kimmel C. A., Faustman E. M. Dose-response assessment for developmental toxicity. III. Statistical models. Fundam. Appl. Toxicol. 23:1994a;496-509.
2. Allen B. C., Kavlock R. J., Kimmel C. A., Faustman E. M. Dose-response assessment for developmental toxicity. II. Comparison of generic benchmark dose estimates with no observed adverse effect levels. Fundam. Appl. Toxicol. 23:1994b;487-495.
3. Auton T. R. Calculation of benchmark doses from teratology data. Regul. Toxicol. Pharmacol. 19:1994;152-167.
4. Barnes D. G., Dourson M. Reference dose (RfD): Description and use in health risk assessments. Regul. Toxicol. Pharmacol. 8:1988;471-486.
5. Barnes D. G., Daston G. P., Evans J. S., Jarabek A. M., Kavlock R. J., Kimmel C. A., Park C., Spitzer W. L. Benchmark dose workshop: Criteria for use of a benchmark dose to estimate a reference dose. Regul. Toxicol. Pharmacol. 21:1995;296-306.
6. Bosch R. J., Wypij D., Ryan L. M. A semiparametric approach to risk assessment for quantitative outcomes. Risk Anal. 16:1996;657-665.
7. Breslow N. E., Clayton D. G. Approximate inference in generalized linear mixed models. J. Am. Stat. Assoc. 88:1993;9-25.
8. Carr G. J., Portier C. J. An evaluation of the Rai and Van Ryzin dose-response model in teratology. Risk Anal. 84:1991;966-971.
9. Carr G. J., Portier C. J. An evaluation of some methods for fitting dose-response models to quantal-response developmental toxicology data. Biometrics. 49:1993;779-791.
10. Catalano P. J., Ryan L. M. Bivariate latent variable models for clustered discrete and continuous outcomes. J. Am. Stat. Assoc. 87:1992;651-658.
11. Catalano P. J., Scharfstein D. O., Ryan L., Kimmel C., Kimmel G. Statistical model for fetal death, fetal weight, and malformation in developmental toxicity studies. Teratology. 47:1993;281-290.
12. Catalano P. J., Scharfstein D. O., Ryan L. Modeling fetal death and malformation in developmental toxicity. Risk Anal. 14:1994;629-637.
13. Chen J. J., Kodell R. L. Quantitative risk assessment for teratologic effects. J. Am. Stat. Assoc. 84:1989;966-971.
14. Chen J. J., Kodell R. L., Howe R. B., Gaylor D. W. Analysis of trinomial responses from reproductive and developmental toxicity experiments. Biometrics. 47:1991;1049-1058.
15. Chen J. J., Gaylor D. W. Dose-response modeling of quantitative response data for risk assessment. Commun. Stat. Theory Methods. 21:1992;2367-2381.
16. Chen J. J. A Malformation incidence dose-response model incorporating fetal weight and/or litter size as covariates. Risk Anal. 13:1993;559-564.
17. Chen J. J., Li L. A. Dose-response modeling of trinomial responses from developmental experiments. Stat. Sin. 4:1994;265-274.
18. Crowder M. J. Beta-binomial ANOVA for proportion. Appl. Statist. 27:1978;34-37.
19. Crump K. S. A new method for determining allowable daily intakes. Fundam. Appl. Toxicol. 4:1984;854-871.
20. Crump K. S. Calculation of benchmark doses from continuous data. Risk Anal. 15:1995;79-89.
21. Faustman E. M., Wellington D. G., Smith W. P., Kimmel C. A. Characterization of a developmental toxicity dose-response model. Environ. Health Perspect. 79:1989;229-241.
22. Fung K. Y., Krewski D., Rao J. N. K., Scott J. A. Tests for trend in developmental toxicity experiments with correlated binary data. Risk Anal. 14:1994;639-648.
23. Gaylor D. W. Quantitative risk analysis for quantal reproductive and developmental effects. Environ. Health Perspect. 79:1989;243-246.
24. Gaylor D. W. Incidence of developmental defects at the no observed adverse effect level (NOAEL). Regul. Toxicol. Pharmacol. 15:1992;151-160.
25. Gaylor D. W., Slikker W. Jr. Risk assessment for neurotoxic effects. Neuro Toxicol. 11:1990;211-218.
26. Gaylor D. W., Slikker W. Jr. Modeling for risk assessment of neurotoxic effects. Risk Anal. 14:1994;333-338.
27. Gart J. J., Krewski D., Lee P. N., Tarone R. E., Wahrendorf J. Statistical Methods in Cancer Research. 1986;International Agency for Research on Cancer, Lyon.
28. George O., Bowman D. A full likelihood procedure for analyzing exchangeable binary data. Biometrics. 51:1995;512-523.
29. Haseman J. K., Kupper L. L. Analysis of dichotomous response data from certain toxicological experiments. Biometrics. 35:1979;281-293.
30. Haws L. S., Jackson B. A., Turnbull D., Dressler W. E. Two approaches for assessing human safety of disperse blue 1. Regul. Toxicol. Pharmacol. 19:1994;80-96.
31. Holson J. F., Gaines T. B., Nelson C. J., LaBorde J. B., Gaylor D. W., Sheehan D. M., Young J. F. Developmental toxicity of 2,4,5-trichlorophenoxyacetic acid (2,4,5-T. I. Multireplicated dose-response studies in four inbred strains and one outbred stock of mice. Fundam. Appl. Toxicol. 19:1992;286-297.
32. Howe, R. B. Crump, K. S. VanLandingham, C. 1986, GLOBAL86: A Computer Program to Extrapolate Quantal Animal Toxicity Data to Low Doses, K. S. Crump and Co, Inc. 1201 Gaines St. Ruston, LA, 71270.
33. Kimmel C. A., Gaylor D. W. Issues in qualitative and quantitative risk analysis for developmental toxicity. Risk Anal. 8:1988;15-20.
34. Kodell R. L., West R. W. Upper confidence limits on excess risk for quantitative responses. Risk Anal. 13:1993;177-182.
35. Krewski D., Zhu Y. Applications of multinomial dose-response models in developmental toxicity risk assessment. Risk Anal. 14:1994;613-627.
36. Krewski D., Zhu Y. A simple data transformation for estimating benchmark dose in developmental toxicity experiments. Risk Anal. 15:1995;29-39.
37. Kupper L. L., Haseman J. K. The use of a correlated binomial model for the analysis of certain toxicological experiments. Biometrics. 34:1978;69-76.
38. Kupper L. L., Portier C., Hogan M. D., Yamamoto E. The impact of litter effects on dose-response modeling in teratology. Biometrics. 42:1986;85-98.
39. Lefkopoulou M., Ryan L. Global tests for multiple binary outcomes. Biometrics. 49:1993;975-988.
40. Leisenring W., Ryan L. Statistical properties of the NOAEL. Regul. Toxicol. Pharmacol. 15:1992;161-171.
41. Liang K. Y., Zeger S. L. Longitudinal data analysis using generalized linear models. Biometrika. 73:1986;13-22.
42. McCullagh P., Nelder J. A. Generalized Linear Models. 1989;Chapman and Hall, London.
43. Morgan B. J. T. Analysis of Quantal Response Data. 1992;Chapman and Hall, London.
44. Moser C. V., Cheek B. M., MacPhail R. C. A multidisciplinary approach to toxicological screening: III. neurobehavioral toxicity. J. Toxicol. Environ. Health. 45:1995;173-210.
45. Paul S. R. On the beta-correlated binomial (bcb). distribution - A three parameter generalization of the binomial distribution. Commun. Statist. Theory Methods. 16:1987;1473-1478.
46. Piegorsch W. Biometrical methods for testing dose effects of environmental stimuli in laboratory studies. Environmetrics. 4:1993;483-505.
47. Price C. J., Kimmel C. A., George J. D., Marr M. C. The developmental toxicity of diethylene glycol dimenthyl ether in mice. Fundam. Appl. Toxicol. 81:1987;113-127.
48. Rai K., Van Ryzin J. A dose-response model for teratological experiments involving quantal responses. Biometrics. 41:1985;1-9.
49. Ryan L. M., Catalano P. J., Kimmel C., Kimmel G. Relationship between fetal weight and malformation in developmental toxicity studies. Teratology. 44:1991;215-223.
50. Ryan L. M. The use of generalized estimating equations for risk assessment in developmental toxicity. Risk Anal. 12:1992a;439-447.
51. Ryan L. M. Quantitative risk assessment for developmental toxicity. Biometrics. 48:1992b;163-174.
52. Slikker W. Jr., Ali S. F., Scallet A. C., Frith C. H., Newport G. D., Bailey J. R. Neurochemical and neurohistological alterations in the rat and monkey produced by orally administered methylenedioxymethamphetamine (MDMA). Toxicol. Appl. Pharmacol. 94:1988;448-457.
53. Slikker W. Jr., Holson R. R., Ali S. F., Kolta M. G., Paule M. G., Scallet A. C., McMillan D. E., Bailey J. R., Hong J. S., Scalzo F. M. Behavioral and neuro-chemical effects of orally administered MDMA in the rodent and non-human primate. Neuro Toxicology. 10:1989;529-542.
54. Stiteler, W. M. Joly, D. A. Printup, H. A. T. 1993, Monte Carlo Investigation of Issues Relating to the Benchmark Dose Method, U.S. Environmental Protection Agency, Cincinnati, OH.
55. Fed. Reg. 56:1991;63797-63826.
56. West R. W., Kodell R. L. Statistical methods of risk assessment for continuous variables. Commun. Stat. Theory Methods. 22:1993;3363-3376.
57. Williams D. A. The analysis of binary responses from toxicological experiments involving reproduction and teratogenicity. Biometrics. 31:1975;949-952.
58. Williams D. A. Extra-binomial variation in logistic linear models. Appl. Stat. 31:1982;144-148.
59. Williams D. A. Dose-response models for teratological experiments. Biometrics. 43:1987;1013-1016.
60. Williams D. A. Estimation bias using the beta-binomial distribution in teratology. Biometrics. 44:1988;305-309.
61. Zeger S. L., Liang K.-Y. Longitudinal data analysis for discrete and continuous outcomes. Biometrics. 42:1986;121-130.
62. Zhu Y., Krewski D., Ross W. H. Multinomial models for developmental toxicity experiments. Appl. Stat. 43:1994;583-598.