The COC has recently published three guidance statements relating to cancer hazard and risk characterisation methods. Conclusions of interest included:

  • The Committee recommends the use of the benchmark dose (e.g. BMDL) as the point of departure for all carcinogens, including genotoxic carcinogens.
  • There are uncertainties in assessing carcinogenic risk in humans from data generated in laboratory animals, and steps are being taken to replace, where possible, the two-year rodent bioassay with alternatives that more accurately predict human cancer risk.
  • The Committee found that the rasH2 transgenic mouse model is a promising replacement for the conventional 2-year bioassay, as this newer test was shown to perform adequately for both genotoxic and non-genotoxic human carcinogens and is not overly sensitive.
  • It was found that initiation-promotion models are not suitable for use in carcinogenicity testing strategies, although they may be useful in mechanistic investigations.
  • Omics technologies may be usefully incorporated into future strategies based on human-relevant modes of action, but are not yet sufficiently developed to be used in the formal assessment of carcinogenic risk to humans. A better understanding of key biomarkers will be required before omics techniques can progress.

Committee on Carcinogenicity of Chemicals in Food, Consumer Products and the Environment (2019).

Alternatives to the 2-year bioassay. Statement COC/G07 – Version 1.1.

Cancer Risk Characterisation Methods. COC Guidance Statement G06 –version 1.1.

Defining a point of departure and potency estimates in carcinogenic dose response. COC Guidance Statement G05 –version 1.1.


The above items were taken from the July 2019 issue of Toxicology and Regulatory News which is sent automatically to members of bibra.

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