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. https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/803050/G07_Alternatives_to_the_2-year_Bioassay_v1.1.pdf

Cancer Risk Characterisation Methods. COC Guidance Statement G06 –version 1.1. https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/803675/G06_Cancer_Risk_Characterisation_v1.1.pdf

Defining a point of departure and potency estimates in carcinogenic dose response. COC Guidance Statement G05 –version 1.1. https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/803674/G05_Points_of_Departure_and_Potency_Estimates_v1.1.pdf

 

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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