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Table 7 OECDs reporting requirements, modified evaluation criteria/questions concerning dosing system, 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 concentration control analysis.

Recommended

Concentrations are not measured in four studies.

 

Data on dosing the test substance (static, semi-static, flow through system).

Recommended

Not clearly stated, but could be understood for all but one study.

 

Data on the exposure period.

Recommended

Stated in all studies.

Durda and Preziosi

Dose (measured preferred).

Mandatory

Concentration ranges are presented for two studies, tested concentrations are lacking for two studies, concentrations are not measured in four studies.

 

Administration route (environmentally relevant preferred).

Mandatory

Not clearly stated, but could be understood for all but one study.

 

Exposure schedule (intermittent, continuous or ad libitum).

Recommended

Not stated in one study.

 

Exposure duration.

Mandatory

Stated in all studies.

Hobbs et al.

Were the chemical concentrations measured?

0 or 4

Concentrations are not measured in four studies.

 

Was the type of exposure (e.g., static, flow through) stated?

0 or 4

Not clearly stated, but could be understood for all but one study.

 

Was the duration of the exposure stated (e.g., 48 or 96 h)?

0 or 10

Stated in all studies.

Schneider et al.

Are doses administered or concentrations in application media given?

Mandatory, 0, or 1

Concentration ranges are presented for two studies, tested concentrations are lacking for two studies. Concentrations are not measured in four studies.

 

For inhalation studies and repeated dose toxicity studies only (give point for other study types): Were achieved concentrations analytically verified or was stability of the test substance otherwise ensured or made plausible?

Recommended, 0, or 1

No inhalation and/or repeated dose toxicity study was evaluated.

 

Is the administration route given?

Mandatory, 0, or 1

Not clearly stated, but could be understood for all but one study.

 

Are sufficient details of the administration scheme given to judge the study?

Recommended, 0, or 1

Not stated in three studies.

 

Are frequency and duration of exposure as well as time-points of observations explained?

Mandatory, 0, or 1

Stated in all studies.

OECD guidelines

Date of start of the test; test duration; test procedure used (e.g., semi-static or flow through); method of preparation of stock solutions; test concentrations, nominal and measured; the recovery efficiency of the method; the limit of quantification in the test matrix.

Mandatory

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