Recent developments in regulatory requirements for developmental toxicology

Toxicology Letters
C A Kimmel, S L Makris

Abstract

A number of legislative and regulatory changes have occurred over the past 5 years to prompt the re-evaluation of the regulatory requirements for developmental toxicity testing and use of the data for risk assessment. In particular, passage of the 1996 Food Quality Protection Act (FQPA) in the United States required the USEPA to evaluate children's health risks in a more rigorous fashion, and to apply an additional 10-fold safety factor if data were inadequate or children appeared to be more sensitive than adults. A review of the testing protocols required by USEPA led to extension of the dosing period to term in the prenatal developmental toxicity study and the addition of endpoints to the 2-generation reproduction study protocol as indicators of possible neurologic, reproductive, or immune alterations. Revised testing guidelines for pesticides and toxic substances were published by USEPA in 1998, including a developmental neurotoxicity testing protocol. Further review for FQPA implementation resulted in the proposal for a core set of required toxicology studies, including routine developmental neurotoxicity, adult neurotoxicity, and adult immunotoxicity studies. In addition, development of new testing guidelines in several ar...Continue Reading

References

Apr 1, 1986·Environmental Health Perspectives·C A KimmelV Frankos
Apr 1, 1996·Environmental Health Perspectives·B Ulbrich, A K Palmer

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Citations

Aug 10, 2006·Maternal and Child Health Journal·Melissa A McDiarmid, Kim Gehle
Jul 9, 2004·Toxicology and Applied Pharmacology·Vincent F Garry
Jul 23, 2005·International Journal of Toxicology·Virginia C MoserTracey Zoetis
Jan 24, 2014·BioMed Research International·Lia de Barros Leite AlbuquerqueYoko Oshima-Franco
Sep 6, 2005·Environmental Health Perspectives·Deborah A Cory-SlechtaEric K Richfield
Feb 3, 2004·Environmental Health Perspectives·LaRonda L MorfordJohn M DeSesso
May 12, 2004·Regulatory Toxicology and Pharmacology : RTP·Paul Baldrick
Nov 29, 2002·International Journal of Hygiene and Environmental Health·William W Au
Sep 7, 2017·Birth Defects Research·Geertje Lewin, Mark E Hurtt
Aug 31, 2004·Birth Defects Research. Part B, Developmental and Reproductive Toxicology·M E HurttG D Cappon
Dec 12, 2003·Birth Defects Research. Part B, Developmental and Reproductive Toxicology·Mark E Hurtt, J David Sandler
Aug 26, 2006·Birth Defects Research. Part A, Clinical and Molecular Teratology·Christopher TonCatherine Willett
Apr 19, 2005·Birth Defects Research. Part B, Developmental and Reproductive Toxicology·Barbara GrajewskiMelissa A McDiarmid
Jul 18, 2003·Birth Defects Research. Part B, Developmental and Reproductive Toxicology·Mark E Hurtt, J David Sandler
Oct 28, 2019·Chemical Research in Toxicology·Zhengxi WeiMenghang Xia
Jan 15, 2008·Reproductive Toxicology·Joanna Blaszkowska

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