IMR Press / FBE / Volume 5 / Issue 2 / DOI: 10.2741/E625

Frontiers in Bioscience-Elite (FBE) is published by IMR Press from Volume 13 Issue 2 (2021). Previous articles were published by another publisher on a subscription basis, and they are hosted by IMR Press on imrpress.com as a courtesy and upon agreement with Frontiers in Bioscience.

Open Access Review

A step change towards risk assessment in the 21st century

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1 DuPont Haskell Global Centers for Health and Environmental Sciences, 1090 Elkton Road, Newark, DE 19711, USA

*Author to whom correspondence should be addressed.

Academic Editor: Aliuska Duardo-Sanchez

Front. Biosci. (Elite Ed) 2013, 5(2), 418–434; https://doi.org/10.2741/E625
Published: 1 January 2013
(This article belongs to the Special Issue Legal issues for chem-bioinformatics models)
Abstract

Chemical Regulation and the means by which data is generated for the purposes of risk assessment is undergoing a tremendous shift. There is a strong impetus in Europe, in particular, to move towards non-animal approaches to address data gaps for specific endpoints either in lieu of testing or as part of weight of evidence approaches within integrated testing strategies (ITS). An Exposure assessment considering workers and/or consumers is a critical component of a robust risk assessment. The EU chemicals legislation REACH, for example, provides considerable flexibility in the application of non-testing approaches such as (Q)SARs, chemical categories and read-across for data gap filling. There have been a number of efforts aimed at developing technical guidance, tools, and techniques for non-testing and tiered exposure approaches. Despite these efforts, there remains limited practical insight about how these approaches can be applied in the assessment of substances. Here, we first provide a background of the available approaches and how they can and should be practically utilised to address REACH requirements.

Keywords
REACH
Non-testing approaches
(Q)SARs
Chemical Categories
Read-Across
Exposure Assessment
Review
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