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OECD: Guidance On Grouping Of Chemicals, Second Edition (2014)

Description:

This guidance document is part of the OECD effort to provide guidance for assessing the hazards of

chemical substances while gaining efficiencies and improving animal welfare. The approach described in this guidance document is to consider closely related chemicals as a group, or category, rather than as individual chemicals. In the category approach not every chemical needs to be tested for every endpoint. Instead, the overall data for that category should prove adequate to support a hazard assessment. The overall data set must enable an estimate of hazard for the untested endpoints.

Although this approach has been used on an ad hoc basis in many regulatory programmes for many years,

guidance was first developed by the US-EPA in support of the US HPV Challenge Program in 1998. The same guidance was also embedded into the OECD Manual for the Assessment of Chemicals. Since then, guidance has evolved continuously based on experience with the approach within the OECD Cooperative Chemicals Assessment Programme, as well as national/regional regulatory and voluntary frameworks. The publication of this guidance document in the Series on Testing and Assessment of the OECDEnvironment, Health and Safety Publications is aimed at improving the visibility of this approach and recommending its wider use. Since the technique of assessing groups of substances is an evolving science, this guidance document is revised periodically. Furthermore, due to the developing nature of the approach as well as its complexity, early consultations between industry and authorities are recommended to ensure that any regulatory requirements are fulfilled if applying it for that purpose. The OECD Guidance reflects on the elements common to a number of different applications and real examples of grouping approaches to help users understand basic concepts. Users will need to take account of the fact that the OECD Guidance cannot cover all the regulatory requirements that may apply to their situation. The present document is the second edition of the guidance, initially published in 2007. This edition has been augmented with experience and examples encountered in the OECD Cooperative Chemicals Assessment Programme, formerly the HPV Chemicals Programme since 2007. The second edition also intends to introduce new or revised guidance on: elaborating the analogue and category approach, quantitative and qualitative read-across, justifying read-across, using bioprofiling results for grouping chemicals, and specific types of category approaches (e.g. chemicals of variable composition, and metals).

Why this Tool/Guidance?

The guidance first explains in Chapter 2 what a category is and outlines relevant concepts that will enable

the reader to better understand the remainder of the document. This chapter outlines general aspects of

grouping chemicals such as the identification of analogues /members of categories, the mechanistic basis for using analogues or chemical categories, and the robustness of both approaches. Chapter 2 also describes the close relationship that exists between (Q)SARs and categories, both in terms of the concepts and in the use of (Q)SARs for data evaluation and data gap filling. Chapter 3 explains the main approaches that are used for data gap filling: read-across, trend analysis and (Q)SARs. While Chapters 2 and 3 provide explanations on the scientific and methodological background of the analogue and category approaches, respectively, Chapters 4-7 focus on practical aspects for forming and documenting analogue and chemical category approaches. Separate chapters (4 and 5) were elaborated to provide guidance on the stepwise procedures for analogue and chemical category approaches, such that the guidance document can be used in a “modular” fashion, and therefore making it possible to use parts of the guidance only. Accordingly a number of text repetitions were necessary. Chapter 6 elaborates on some of the specific issues that need to be addressed with certain types of chemical substances. Finally, in Chapter 7, formats are proposed to structure the documentation of analogue and category approaches, so-named analogue/category reporting formats (ARF, CRF).

Continue to:

OECD Guidance on Grouping of Chemicals, Second edition external link

 


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