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:
- Not assessing on an endpoint (waiving) of the submission item
- e.g. biodegradation or persistence of inorganic substances - 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 - 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) - 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)
