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Table 8 OECDs reporting requirements, modified evaluation criteria/questions concerning test species, 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 resultsa

Klimisch et al.

Data on the test species and the number of individuals tested.

Recommended

Not stated in one study.

 

Information about the investigated period of the life cycle of the test animals (chronic studies).

Recommended

Not stated in three studies.

Durda and Preziosi

Body weight or length.

Recommended

Not stated in two studies.

 

Age/life stage.

Recommended

Not stated in three studies.

 

Reproductive condition.

Recommended

Not stated in four studies.

 

Gender.

Recommended

Not stated in one study.

 

Strain.

Recommended

Not stated in four studies.

 

Source.

Recommended

Not stated in one study.

 

No previous exposure (e.g., for field-collected specimens).

Recommended

No field-collected test species.

 

No concomitant exposure (e.g., during field studies).

Recommended

No field studies.

Hobbs et al.

Were the characteristics of the test organism (e.g., length, mass, age) stated?

0 or 5

Not stated in two studies.

Schneider et al.

Is the species given?

Mandatory, 0, or 1

Stated in all of the studies.

 

Is age or body weight of the test organisms at the start of the study given?

Recommended, 0, or 1

Body weight is not stated in two studies, age is not stated in three studies.

 

Is the sex of the test organism given?

Recommended, 0, or 1

Not stated in one study.

 

Is information given on the strain of test animals plus, if considered necessary to judge the study, other specifications (see explanation for examples)?

Recommended, 0, or 1

Not stated in four studies.

OECD guidelines

Scientific name; strain/clone; source; culture conditions including medium and volume; methods of collection.

Mandatory

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

  1. aSome aspects are not relevant for all studies, depending on choice of test species. This has been considered in the evaluation.