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The biological significance of chemically-induced DNA adducts, the investigation of the possible presence of thresholds, and the use of adducts in genotoxicity hazard and risk assessment.

Background

How to best use the identification and quantification of DNA adducts, in the evaluation of potential human and animal carcinogenicity, has been a perplexing issue ever since their presence, following chemical exposure, was established. The application of biomarker data, especially DNA adducts, to overall hazard and risk-assessment remains a major science issue. Growing debate around the existence, or absence, of a threshold for genotoxic, mutagenic and/or carcinogenic effects demands data inter alia to understand better the biological significance of DNA adducts. Certainly, as bio-monitoring studies in worker populations increase in number and sensitivity, questions about the biological significance and potential health implications of DNA adducts will become more important, not only for the chemical industry, but also for the regulatory community. How such data will be used will depend heavily on scientific information derived from studies of genotoxic and carcinogenic chemicals in animals. This issue offers the opportunity to set a precedent for the interpretation and use of surrogate data derived from animal studies, to allow an integrated, weight of evidence approach to assessing the risk to humans of chemicals.

Objectives

The development of a logical, innovative approach to collection and analysis of data enabling appropriate scientific and regulatory use of data on DNA adducts and their application in human risk assessment. This might include the demonstration of a threshold for the mutagenic effect, or a lack of mutagenic effect, associated with specific adducts.
Through such approaches it is envisaged that improved carcinogen risk assessment processes will emerge.

Scope

Proposals submitted for consideration should address the following under individual headings:

  • The title of the research proposal.
  • The name and affiliation of the Principal Investigator of the laboratoryor laboratories in which the research will be conducted.
  • Evidence of the Principal Investigator's expertise, and contributions to the areas of science relevant to this proposal.
  • A clear definition of the research objectives (including a description of the mechanistic basis for any proposed research).
  • An outline of investigation including milestones and critical decision points during the course of the proposed project.
  • An indication of likely costs.
  • All applications for CEFIC-LRI grants will be dealt with via a two-tiered selection process. Interested parties are invited to submit an initial expression of interest for preliminary evaluation by an ECETOC Selection Team. A form is available on the CEFIC-LRI web-site. Short-listed candidates will subsequently be requested to submit a more detailed proposal or invited to make a presentation to the Selection Team.

Monitoring:
The Principal Investigator will be required to submit a progress report at six monthly intervals during the course of the programme. At the end of the project, the Principal Investigator will provide a detailed review of the research, and its accomplishments. It is expected that the results will be published in peer-reviewed journals and the investigators are encouraged to present their preliminary findings in appropriate scientific meetings.

 

Timing: It is anticipated that proposed projects will be of either 2 or 3 years duration.

Cost: The support available for this programme of work is in the region of €150k per annum.

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