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Table 4 OECDs reporting requirements, modified evaluation criteria/questions concerning protocol, 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

Klimisch et al.

Clear description of the test procedure (complete documentation).

Recommended

Not stated in three studies.

Durda and Preziosi

Protocol described and followed (standardized protocol/validated protocol/published peer-reviewed protocol/scientifically accepted protocol). Tests are recommended to be conducted using good laboratory practices (GLP).

Mandatory/recommended

All studies are peer reviewed and non-standard, but not according to GLP.

 

Peer-reviewed study

Recommended

All studies are peer reviewed.

Schneider et al.

Is the study design chosen appropriate for obtaining the substance-specific data aimed at?

Mandatory, 0, or 1

Appropriate study design for dose-response analyses for all studies.

OECD guidelines

Clear reporting instructions for each test standard.

Mandatory

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