Chapter 6

Ecotoxicology: Test on significant toxicity

What is specific in ecotoxicological assays? First, dose-response analysis is focusing on potency measures, particularly the no-observed adverse effect level (NOAEL) or the benchmark dose (see Section 7.2). Second, a feasible proof of safety approach is proposed by an authority body, the US EPA [92], denoted as test on significant toxicity (TST). Third, a rather detailed guideline on statistical methods exists [282].


  • Proof of safety using two-sample non-inferiority tests in aquatic assays
  • Small-sample size ratio-to-control tests: parametric, nonparametric, proportion

6.1 Proof of safety

Some bioassays in regulatory toxicology are carried out to demonstrate the safety of a new ...

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