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
Betton, G.; Cockburn, A.; Harpur, E.; Hopkins, J.; Illing, P.; Lumley, C.; Connors, T.; Betton, G., Zeneca Pharmaceuticals, Alderley Park, Macclesfield, SK10 4TG; Cockburn, A., Schering Agrochemicals Limited, Chesterford Park Research Station, Saffron Walden, Essex, CB10 1XL; Harpur, E., Sterling Winthrop Pharmaceuticals Research Division, Sterling Winthrop Research Centre, Alnwick, Northumberland, NE66 2JH; Hopkins, J., BIBRA Toxicology International, Woodmansterne Road, Carshalton, Surrey, SM5 4DS; Illing, P., HSE, Magdalen House, Bootle, Merseyside, L20 3QZ; Lumley, C., CMR, Woodmansterne Road, Carshalton, Surrey, SM5 4DS; Connors, T., Former Director, MRC Toxicology Unit, Woodmansterne Road, Carshalton, Surrey, SM5 4DS, UK
Журнал:
Human and Experimental Toxicology
Дата:
1994
Аннотация:
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.<sup>1,2</sup> 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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