A regression spline model for developmental toxicity data

Toxicological Sciences : an Official Journal of the Society of Toxicology
Daniel L Hunt, Chin-Shang Li

Abstract

Observed dose-response patterns of data from several developmental toxicity experiments appear to be nonlinear and should be characterized by an appropriate model to adequately fit this observed pattern. Information from these animal studies of ambient substances that are noncarcinogenic, yet potentially toxic, to humans is used by federal protection agencies (Environmental Protection Agency, Occupational Safety and Health Administration, Food and Drug Administration) to determine safe exposure levels, such as no observed adverse effects level and benchmark dose. We have developed a flexible regression linear B-spline model for application to developmental toxicity dose-response data from animal studies of these noncarcinogens. We apply our model to data from two CD-1 mice studies of the National Toxicology Program; the observed dose-response pattern from both appears nonlinear: (1) experiment of 131 pregnant mice allocated over five exposure levels (0, 0.025, 0.05, 0.10, and 0.15% diet) of diethylhexyl phthalate and (2) experiment of 111 pregnant mice exposed to five levels (0, 62.5, 125, 250, and 500 mg/kg/day) of diethylene glycol dimethyl ether. In each study, we measure litter response as the proportion of adversely affect...Continue Reading

References

Oct 1, 1984·Fundamental and Applied Toxicology : Official Journal of the Society of Toxicology·K S Crump
Jul 2, 1999·Regulatory Toxicology and Pharmacology : RTP·J DoullM van Gemert
Feb 13, 2001·Statistics in Medicine·N MolinariJ F Durand
Mar 19, 2004·Risk Analysis : an Official Publication of the Society for Risk Analysis·Daniel L Hunt, Dale Bowman

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Citations

Mar 17, 2007·Risk Analysis : an Official Publication of the Society for Risk Analysis·Christel FaesGeert Molenberghs
Dec 5, 2017·Journal of Occupational and Environmental Medicine·Gretchen M BruceRichard C Pleus
Dec 24, 2018·Dose-response : a Publication of International Hormesis Society·Anatoly N VaraksinIlzira A Minigalieva

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