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Table 5 OECDs reporting requirements, modified evaluation criteria/questions concerning test substance, 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.

Specification of the test substance (purity, by-products).

Recommended

Purity is not stated in six studies, by-products are not stated in any of these studies.

 

Data on neutralization of samples (for basic or acid substances).

Recommended

Not stated in any of these studies.

 

Use of emulgators/solubilizers.

Recommended

Not stated in any of these studies.

Durda and Preziosi

Chemical species noted.

Recommended

Stated in all studies.

 

Chemical source noted.

Recommended

Not stated in one study.

 

Purity/stability noted.

Recommended

Purity is not stated in six studies, stability is not stated in any of these studies.

 

Vehicle described (if used).

Recommended

Not stated in four studies.

Hobbs et al.

Were analytical reagent grade chemicals or the highest possible purity chemicals used for the experiment?

0 or 3

Not stated in six studies.

Schneider et al.

Is information on the source/origin of the substance given?

Recommended, 0, or 1

Not stated in one study.

 

Was the test substance identified?

Mandatory, 0, or 1

Stated in all studies.

 

Is the purity of the substance given?

Recommended, 0, or 1

Not stated in six studies.

 

Is all information on the nature and/or physicochemical properties of the test item given, which you deem indispensable for judging the data?

Recommended, 0, or 1

Not stated in five studies.

OECD guidelines

Chemical identification data (e.g., CAS Number); physical nature and relevant physical-chemical properties; water solubility; purity; stability; suspended solids.

Mandatory

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