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Table 10 OECDs reporting requirements, modified evaluation criteria/questions concerning statistical design, 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.

Data on the statistical evaluations (including method).

Recommended

Not stated in two studies, results missing for one study.

Durda and Preziosi

Sufficient sample size/replicates.

Recommended

Not stated in one study, sufficient in all other studies.

 

Randomized treatments.

Recommended

Not stated in any of these studies.

 

Independence of observations.

Recommended

Not stated in any of these studies.

 

Appropriate statistical model.

Recommended

Not stated in two studies.

 

Statistically significant responses noted.

Recommended

Not stated in three studies.

Hobbs et al.

Was each control and chemical concentration at least duplicated?

0 or 5

Not stated in one study, controls not stated in two studies.

 

Was an appropriate statistical method or model used to determine the toxicity?

0 or 4

Not stated in two studies.

 

For NOEC and LOEC data was the significance level 0.05 or less? or FOR LC and EC data was an estimate of variability provided?

0 or 4

Not stated in five studies.

Schneider et al.

Is the number of animals per group given?

Mandatory, 0, or 1

Not stated in one study.

 

Are the statistical methods applied for data analysis given and applied in a transparent manner?

Recommended, 0, or 1

Not stated in three studies.

OECD guidelines

Statistical analysis and treatment of data; number of test chambers and replicates; number of embryos per replicate; if ANOVA has been used, the size of the effect which can be detected (e.g., the least significant difference).

Mandatory

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