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Next Step Toward Implementing the Requirements for Environmental Risk Assessment of Nanomaterials
The new standard test method is designed to investigate the solubility and dissolution rate of nanomaterials under relevant environmental conditions. It thus represents an important new building block for an appropriate environmental risk assessment within the framework of chemical safety regulations.
OECD Test Guideline No. 322 enables the investigation of key parameters for assessing the behavior and fate of nanomaterials in the environment. Using the newly developed methods, solubility and dissolution rates can be determined under relevant environmental conditions. On this basis, regulatory information requirements regarding the dissolution behavior of nanomaterials can be met. Furthermore, it becomes possible to determine whether nanomaterials released into the environment remain present as nanomaterials or are rapidly dissolved. This can provide a basis for deciding whether a nanomaterial-specific environmental assessment is necessary. In addition to other parameters such as dispersion stability or transformation, data on the dissolution rate are essential for assessing the environmental behavior of nanomaterials. Information on the dissolution rate in biological and environmental media is therefore part of the requirements that must be met for nanomaterials under the European REACH Regulation.
The OECD Test Guidelines for the testing of chemicals comprise a series of standardized, internationally harmonized, and accepted test methods and guidelines that can be used to characterize chemicals and investigate their potentially harmful behavior and effects on humans and the environment. These test guidelines were developed primarily for water-soluble, organic chemicals. However, the behavior of nanomaterials in the environment and in humans differs significantly from that of these chemicals; thus, while it is recognized that the existing OECD test guidelines are generally applicable to nanomaterials as well, there is nevertheless a need for adaptation and supplementation.
The test guideline that has now been adopted was developed by the Department of Environmental Geosciences at the University of Vienna and the Fraunhofer Institute for Molecular Biology and Applied Ecology IME on behalf of the Federal Environment Agency and with funding from the Federal Ministry for the Environment, Climate Action, Nature Conservation, and Nuclear Safety. Under the leadership of these two research institutions, the test guideline was also validated in an international interlaboratory comparison test.
Fraunhofer Institute for Molecular Biology and Applied Ecology IME