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Table 9 OECDs reporting requirements, modified evaluation criteria/questions concerning controls, and a 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

Durda and Preziosi

Control media identical to test media in all respect except the treatment variable.

Mandatory

Not stated in any of these studies, controls not stated at all in two studies.

 

Control and test organism drawn from same population.

Mandatory

Not stated in any of these studies, controls not stated at all in two studies.

 

Acceptable control mortality/morbidity (approx. 10%).

Mandatory

Not stated in any of these studies.

 

Vehicle control (as appropriate).

Recommended

Not stated in six studies.

 

Positive and/or negative control (optional).

Recommended

Controls not stated in two studies.

Hobbs et al.

Were test acceptability criteria stated (e.g., mortality in controls must not exceed a certain percentage) OR

0 or 5

Not stated in any of these studies.

 

Were the acceptability criteria inferred (e.g., test method used [USEPA, OECD, ASTM etc.] uses validation criteria) (award 2 marks).

0, 2, or 5

No standard tests were evaluated.

 

Were appropriate controls (e.g., no-toxicant control and/or solvent control) used?

0 or 5

Not stated in two studies.

 

Were parallel reference toxicant toxicity test conducted?

0 or 4

Not stated in any of these studies.

Schneider et al.

Were negative (where required) and positive controls (where required) included (give point also, when absent but not required)?

Mandatory, 0 or 1

Not stated in two studies.

 

Are the quantitative study results reliable (variability of controls and treatments)?

Recommended, 0, or 1

Not stated in eight studies.

OECD guidelines

Evidence that controls met the overall survival acceptability standard of the test species.

Mandatory

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