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Integrated testing strategy (ITS) for bioaccumulation assessment under REACH.

Anna Lombardo¹, Alessandra Roncaglioni¹, Emilio Benfentati¹

¹Laboratory of Evironmental Chemistry and Toxicology, Department of Environmental Health Science, IRCCS-Istituto di Ricerche Farmacologiche "Mario Negri," Via G. La Masa 19, Milan 20156, Italy.

Environment International

|May 9, 2014

Summary

This study introduces an integrated testing strategy (ITS) to assess chemical bioaccumulation potential. The new approach significantly reduces animal testing, estimating bioaccumulation using non-animal methods for most chemicals.

Keywords:

Alternative methods Bioaccumulation In silico methods Integrated testing strategy REACH Reduce animal testing

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A Whole Cell Bioreporter Approach to Assess Transport and Bioavailability of Organic Contaminants in Water Unsaturated Systems

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Published on: December 24, 2014

Area of Science:

Environmental Chemistry
Toxicology
Regulatory Science

Background:

The Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation mandates chemical registration with physicochemical, toxicological, and ecotoxicological data.
REACH encourages the adoption of alternative methods to minimize animal testing for toxicity assessments.
Integrated Testing Strategies (ITSs) are crucial for the rational application of non-animal testing approaches in chemical hazard evaluation.

Purpose of the Study:

To present an integrated testing strategy (ITS) specifically designed for evaluating the bioaccumulation potential of organic chemicals.
To demonstrate the feasibility of reducing in vivo animal testing through the application of alternative methods and data analysis.

Main Methods:

The ITS incorporates all available data, including non-optimal datasets and waiving schemes.
It involves the analysis of physicochemical properties relevant to bioaccumulation and the utilization of in silico and in vitro alternative methods.
In vivo testing is reserved as a last resort, employed only when other methods are insufficient.

Main Results:

The developed ITS enabled waiving in vivo testing for approximately 67% of the chemicals examined.
Bioaccumulation potential was successfully estimated for these compounds using exclusively non-animal testing approaches.
The ITS is accessible via a freely available web tool.

Conclusions:

The presented ITS offers a robust framework for assessing chemical bioaccumulation potential while adhering to REACH requirements.
This strategy significantly reduces reliance on animal testing, promoting ethical and efficient chemical safety evaluations.
The availability of the ITS as a web tool facilitates its widespread adoption in regulatory and research settings.