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Table 12 Description and comparison of the four reliability evaluation methods.

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

 

Klimisch et al.

Durda and Preziosi

Hobbs et al.

Schneider et al.

Data types

Toxicity (in vivo and in vitro) and ecotoxicity (acute and chronic) data.

Ecotoxicity data.

Ecotoxicity (both acute and chronic) data.

Toxicity data (both in vivo and in vitro).

Coverage

Reliability.

Reliability.

Reliability.

Reliability and also a few aspects of relevance.

Evaluation categories

Reliable without restrictions, reliable with restrictions, not reliable and not assignable.

High, moderate and low quality, not reliable and not assignable.

High, acceptable and unacceptable quality.

Reliable without restrictions, reliable with restrictions, not reliable and not assignable.

No. of evaluation criteria/questions

12 (acute ecotoxicity), 14 (chronic ecotoxicity).

40

20

21

No. of aspects per criteria/questions

Several.

1

1

Several.

Type of criteria/questions

Recommended.

Recommended and mandatory.

Recommended, mark between 0 and 10.

Recommended and mandatory, mark between 0 and 1.

Additional guidance to evaluator

No.

Yes.

No.

Yes.

Information on how to summarize the evaluation

Not stated.

Stated.

Stated.

Stated and calculated automatically.

Additional information

Recommended in the REACH guidance document for industrial chemicals [39].

Based on standards from US EPA, OECD and ASTM.

Based on a method developed for the Australasian ecotoxicity database.

The method is called ToxRTool (Toxicological data reliability assessment Tool).

No. of OECD criteria that the method matched

14/37

22/37

15/37

14/37

  1. US EPA United States Environmental Protection Agency, OECD Organisation for Economic Co-operation and Development, ASTM American Society for Testing and Materials.