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Non-testing strategies - a tiered approach

Ralf Arno Wess, Harlan Laboratories Ltd., Germany

Computational methods are sometimes considered a black box able to deliver automatically endpoint values plus reports including sufficient methodological information (QMRF, QPRF) just on the basis of a chemical structure information. However this may be achieved a tiered approach is more realistic as experienced on the basis of actual REACH registration work done in a consultancy. Briefly the following options should be checked:

  1. Not assessing on an endpoint (waiving) of the submission item
    - e.g. biodegradation or persistence of inorganic substances
  2. Not testing on an endpoint and assessing on the basis of evidence from available tests with the submission item for a different endpoint
    - Route-to-route extrapolation (ITS, EPM), or (more) chronic instead of (more) acute data;
    - e.g. 90 day Toxicity covering 28 day toxicity; sediment simulation study covering absence of hydrolysis  
  3. Not using target chemical test data but from
    - Test surrogate (identical species, analogue bioavailability)
    - Pre-drug case (metabolite); Actual exposure case
    - An analogue material (analogue species, identical bioavailability)
    - Point-to-point (read across); Trend analysis (QSAR, QSPR) 
  4. Not using mixture / multi-constituent / UVCB test data but from its constituents  
    - Combined action (CA) or Independent action (IA) model

(presenting author: Ralf Arno Wess)

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