A Critical Review of the Optimum Duration of Chronic Rodent Testing for the Determination of Non-Tumourigenic Toxic Potential: A Report by the BTS Working Party on Duration of Toxicity Testing

Abstract

This review indicates that for the detection of non-neoplastic toxic effects:

1 Four decades of accumulated literature provide no lead as to the optimum duration of repeat dose toxicity testing required for all classes of chemicals, although 6 months repeated administration appears adequate for pharmaceuticals.

2 Three month studies predicted the 2 year outcome for 70% of the compounds evaluated in this pilot study using data published by the US National Toxicology Program.

3 In spite of the limitations of this pilot study, this finding is considered encouraging as it is close to that generated previously on more detailed confidential pharmaceutical data.^1,2 This suggests that the exercise should now be expanded using confidential surveys of industrial data to determine the concordance resulting from the evaluation of a larger group of chemicals.

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