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A Developmental and Reproductive Toxicology Program for Chemical Registration

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Book cover Developmental and Reproductive Toxicology

Part of the book series: Methods in Pharmacology and Toxicology ((MIPT))

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Abstract

The goal of the chapter is to outline the process of testing molecules for potential developmental and reproductive toxicity (DART). Here, the entire process of DART testing is discussed, from the regulatory use of DART data to the conduct and interpretation of the various DART study designs. Although non-animal DART testing strategies are envisioned by the new science of “21st Century Toxicity Testing”, these high-content, high-throughput testing paradigms are not sufficiently mature from a scientific perspective to be acceptable on their own by regulatory agencies for chemical registration. Thus, these testing paradigms are not included in this chapter. While the scope of the chapter is broad, it is beyond the range of this chapter to describe all possible scenarios encountered in DART testing. For additional information, the reader is referred to other recent publications on this topic. The chapter is organized in a stepwise manner into three main topics: (1) Use of DART studies for chemical registration; (2) General considerations for all DART study designs; and (3) Descriptions of all DART study designs from a practical perspective, beginning with an initial range-finding study and ending with the complex Extended One-Generation Reproductive Toxicity Study (EOGRTS).

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Acknowledgements

The authors would like to thank Dr. Lynea Murphy for critically reading the manuscript.

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Authors and Affiliations

  1. Toxicology and Environmental Research & Consulting, The Dow Chemical Company, Midland, MI, 48674, USA

    Kamin J. Johnson Ph.D., Bethany R. Hannas, Sue Marty, Carol L. Zablotny & Amanda K. Andrus

  2. Human Health Assessment, Dow AgroSciences LLC, Indianapolis, IN, USA

    Jessica LaRocca

  3. Toxicology and Environmental Research & Consulting, Dow Europe GmbH, Horgen, Switzerland

    Nicholas Ball

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  1. Kamin J. Johnson Ph.D.
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  2. Bethany R. Hannas
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  3. Sue Marty
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Correspondence to Kamin J. Johnson Ph.D. .

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  1. MPI Research, Mattawan, Michigan, USA

    Ali S. Faqi

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Johnson, K.J. et al. (2016). A Developmental and Reproductive Toxicology Program for Chemical Registration. In: Faqi, A. (eds) Developmental and Reproductive Toxicology. Methods in Pharmacology and Toxicology. Humana Press, New York, NY. https://doi.org/10.1007/7653_2016_65

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  • DOI: https://doi.org/10.1007/7653_2016_65

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