In an attempt to harmonize the risk assessment process for genotoxic and carcinogenic substances, the three Scientific Committees on Health and Environmental Risks (SCHER), Consumer Products (SCCP) and Emerging and Newly Identified Health Risks (SCENIHR) have prepared a preliminary report (for public consultation) which reviews the available methods and approaches currently in use. The working group discussed the advantages and disadvantages of (i) the various risk characterization methods – margin of exposure (MOE), weight of evidence, as low as reasonably achievable (ALARA), and threshold of toxicological concern (TTC), (ii) the different dose descriptors – no-observed-adverse-effect level (NOAEL), T25 (the dose corresponding to a 25% tumour incidence in an animal bioassay, after correction for spontaneous incidence), and benchmark dose lower confidence limit (BMDL), and (iii) the different study types – structure activity relationships (SARs), short-term genotoxicity tests, long-term carcinogenicity bioassays, and epidemiology. Certain approaches were favoured for certain situations, e.g. a linear extrapolation method (BMDL10 or T25) for cost-benefit analysis, and the MOE approach for risk communication. It was stressed that each compound needs to be considered on a case-by-case basis, taking into consideration all available information on its toxicokinetics, toxicodynamics and possible mode of action.

[EC. Health and Consumer Protection DG. Risk assessment methodologies and approaches for mutagenic and carcinogenic substances. Preliminary report agreed on 24 October 2008. Available via http://ec.europa.eu/health/ph_risk/committees/04_scher/scher_cons_03_en.htm on the internet. Comments on the document are invited by 2 December 2008.] {179629}

The above item is taken from the December 2008 issue of Toxicology and Regulatory News which is sent automatically to members of bibra (click here for more details).

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