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Optimizing the aquatic toxicity assessment under REACH through an integrated testing strategy (ITS).
Anna Lombardo1, Alessandra Roncaglioni1, Emilio Benfenati1
1IRCCS - Istituto di Ricerche Farmacologiche "Mario Negri", Department of Environmental Health Science, Laboratory of Environmental Chemistry and Toxicology, Via G. La Masa 19, 20156 Milan, Italy.
This study introduces an integrated testing strategy (ITS) to streamline chemical hazard assessment for aquatic environments under REACH regulations. It optimizes data use and prediction methods, minimizing animal testing for regulatory compliance.
Area of Science:
- Environmental Science
- Toxicology
- Regulatory Science
Background:
- REACH regulations necessitate extensive chemical data for the European Chemicals Agency.
- Integrated Testing Strategies (ITSs) offer a framework to organize data and minimize animal testing.
- Assessing hazards to the aquatic pelagic environment requires complex data management.
Purpose of the Study:
- To present an ITS scheme for organizing and utilizing existing data for aquatic toxicity assessment.
- To optimize the selection of prediction strategies for aquatic pelagic toxicity.
- To guide registrants in meeting regulatory data requirements efficiently.
Main Methods:
- Development of an Integrated Testing Strategy (ITS) scheme.
- Inclusion of all available information, including physico-chemical properties.
- Consideration of alternative methods: in silico, in vitro, and acute-to-chronic ratio.
- Application of a weight of evidence approach for data integration.
Main Results:
- An organized ITS scheme for aquatic pelagic toxicity assessment is described.
- The scheme optimizes the choice of prediction strategies.
- It effectively integrates diverse data sources and alternative testing methods.
Conclusions:
- The proposed ITS facilitates efficient and compliant chemical hazard assessment for the aquatic pelagic environment.
- This approach supports regulatory requirements while reducing reliance on animal testing.
- Effective data organization and integration are key to optimizing toxicity predictions.
