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Table 11 OECDs reporting requirements, modified evaluation criteria/questions concerning biological effect, and summary of the evaluation results.

From: Comparison of four different methods for reliability evaluation of ecotoxicity data: a case study of non-standard test data used in environmental risk assessments of pharmaceutical substances

Evaluation method

Evaluation criteria/question

Type of criteria/mark

Summary of evaluation results

Klimisch et al.

Determined effect concentrations (EC/LC/NOEC/LOEC).

Recommended

Not stated in one study but could be understood.

Durda and Preziosi

Quantitative measurement of response.

Recommended

Stated in all studies.

 

Results reproduced by others.

Recommended

Not considered.

 

Consistent with other findings.

Recommended

Not considered.

 

Dose-response observed.

Recommended

Not stated in three studies, no relationship in one study.

Hobbs et al.

Was the biological effect stated (e.g., LC or NOEC)?

0 or 5

Not stated in one study but could be understood.

 

Was the biological effect quantified (e.g., 50% effect, 25% effect)? The effect for NOEC and LOEC data must be quantified.

0 or 5

Info about tested concentrations is missing for one LOEC/NOEC value.

 

Was there a concentration-response relationship either observable or stated?

0 or 4

Not stated in three studies, no relationship for one study.

Schneider et al.

Is the description of the study results for all endpoints investigated transparent and complete?

Recommended, 0, or 1

Not stated in four studies.

OECD guidelines

Concentration-response data, the slope of the dose-response curve and its standard error; EC50 or EC10 and associated confidence intervals; LOEC and NOEC and the statistical methods used for their determination; calculated response variables for each treatment replicate, with mean values and coefficient of variation for replicates.

Mandatory

The non-standard studies were not evaluated according to the OECD reporting requirements.