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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

Zeneca Pharmaceuticals, Alderley Park, Macclesfield, SK10 4TG

A. Cockburn

Schering Agrochemicals Limited, Chesterford Park Research Station, Saffron Walden, Essex, CB10 1XL

E. Harpur

Sterling Winthrop Pharmaceuticals Research Division, Sterling Winthrop Research Centre, Alnwick, Northumberland, NE66 2JH

J. Hopkins

BIBRA Toxicology International, Woodmansterne Road, Carshalton, Surrey, SM5 4DS

P. Illing

HSE, Magdalen House, Bootle, Merseyside, L20 3QZ

C. Lumley

CMR, Woodmansterne Road, Carshalton, Surrey, SM5 4DS

T. Connors

Former Director, MRC Toxicology Unit, Woodmansterne Road, Carshalton, Surrey, SM5 4DS, UK

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.

Human & Experimental Toxicology, Vol. 13, No. 4, 221-232 (1994)
DOI: 10.1177/096032719401300401


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