Cefic-lri Programme | European Chemical Industry Council

Evaluation of fish embryo and fish cell line tests for their potential use as


Animal welfare and the use of animals for environmental safety assessments is an area of
growing public concern and political sensitivity. Concern about animal welfare issues is driving
legislative approaches (e.g. REACH, DGEE, (2003) and the 6th and 7th Amendment to the
Cosmetics Directive EC, 1976; 1993; 2003). The European Commission White Paper on the
future EU Chemicals Policy (DGEE, 2003) defines one of its objectives as the'promotion of nonanimal
The aim of this project is to provide relevant data to support the development of a proposed
strategy intended to replace or reduce the numbers of fish used for assessing acute toxicity of
chemicals (for the purposes of risk assessment and classification). This will include the
generation of data on fish embryos and/or fish cell lines which will also lead to the extension of
their applicability domain. In the course of the project it is anticipated that the use of QSARs
(both as a tool and a component within a strategy) to reduce testing requirements will be


  • Using output from previous programmes which have collected in vivo fish, daphnid and algal data (EC/LC50) from existing data bases; statistically design a proposed set of test chemicals, with the help of QSAR, aiming at careful coverage of chemical domain - to be completed in
    discussion with the Research Liaison Team).
  • Expand knowledge by generation of fish embryo data for OECD accepted fish species, with chemicals selected above, while ensuring a good understanding of the exposure and bioavailability in fish embryo studies - i.e. analysis.
  • Generate cell line battery data (e.g. RTL-W1, RTG-2 and gill cell line using ECVAM draft protocols), for the chemicals selected above, while ensuring a good understanding of the exposure and bioavailability in cell line studies - i.e. analysis.
  • Determine whether acute toxicity, as determined in the current fish test, can be predicted from the fish embryo and/or cell line battery assays and if so, develop appropriate relationships.
  • Using the information gained from the research above, recommend a practical and technically feasible strategy for the replacement of fish in the acute toxicity test (this may involve pregenerated daphnid and algal information (QSAR or experimental)).
  • Evaluate experimental statistics (e.g. reproducibility) and applicability domain.

Timing: 2 - 3 years

Cost: 400,000 EUROS (maximum) from CEFIC LRI - leverage with other organizations will be essential for this project to succeed.

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