Development of a Guidance Document for the interpretation of data on dissolution rate and dispersion stability of nanomaterials for environmental risk assessment
Existing standardized test methods for the investigation of environmental fate and effects of chemicals were initially developed for readily soluble organic substances and not substances of particular nature. In an international effort, the OECD currently focuses on whether or not these test methods can also be applied to investigate fate and effects of nanomaterials. It is highlighted that for some of the OECD test guidelines there is the need for amendment and addition in order to achieve valid and robust data on nanomaterials in the environment. Therefore, inter alia currently test guidelines for the determination of the parameters dissolution rate and dispersion stability are developed. These parameters are important prerequisites for the conduction of further investigations for the assessment of environmental behavior and effects of nanomaterials. Therefore, in this project a guidance document will be developed which provides guidance and recommendations for the use of the test guidelines on dispersion stability and dissolution rate of nanomaterials in aquatic media. Furthermore, this guidance shall address the interpretation of data coming from these test guidelines with respect to the conduction of follow-up testing on environmental fate and effects. In order to realize this guidance document in the framework of the project, conceptual work (including efforts to be made with respect to search for literature and other relevant activities), and – if appropriate - experimental work to verify elements of the guidance document will be conducted. The draft of the guidance shall be submitted to the OECD test guideline program (OECD WNT) as proposal for a new OECD guidance document. (UFORDAT No. 01068942)
Development of an OECD Test Guideline or Guidance on nanomaterial size and size distribution
The characteristics of nanomaterials are influenced by their chemical composition but also by their physical properties (e.g. size, geometry and crystal structure). For a reliable determination and assessment of behaviour and effects of nanomaterials as well as for the determining exposure of humans and environment a comprehensive physical-chemical characterisation of nanomaterials is essential. This is an important prerequisite to be able to identify them as nanomaterials and to interpret and compare test results and - in future – to forecast behaviour and effects of nanomaterials. Existing OECD standardized test methods for the characterisation of physical-chemical properties weren`t developed taking the specifics of nanomaterials into account. Therefore, the project aims to develop a harmonized test protocol for a valid and reproducible determination of particle size and size distribution which is one of the most relevant physical-chemical properties. The project will focus on particulate and fibrous nanomaterials. (UFORDAT No. 01068953)
Investigations on the possible release of nanoparticles during the deposition and soil-related application of mineral waste
In 2015 a research project was completed (UFOPLAN “Survey on possible environmental exposure of disposal of waste containing nanomaterials”) where it was shown that in a waste incineration plant during a state of the art combustion process of nanomaterials containing waste no higher emissions of nanomaterials in the purified exhaust gas were detected. Nanomaterials were mainly found in the solid residues of the combustion process (ashes and slags). The focus of a current UFOPLAN-project (“Investigations on the possible release of nanoparticles during the deposition and soil-related application of mineral waste”) is to analyze to what extent nanoparticles could be released in the environment during recovery and disposal of combustion residues. (UFORDAT Nr. 01064052)
Development of a method for the investigation of bioaccumulation of manufactured nanomaterials in filtering organisms (bivalvia)
Next to persistence and ecotoxicity, the determination of the bioaccumulative potential of substances in environmental organisms is pivotal for the understanding of interactions of substances with the environment. However, the available methods for investigating the bioaccumulation mainly address soluble organic chemicals. If these methods are also applicable for the investigations of nanomaterials remains an open question. If nanomaterials enter into water bodies they agglomerate and sediment in dependency of their properties and the properties of the surrounding media. Therefore, sediments are important target compartments for nanomaterials. Thus, it has to be anticipated that in the long-term nanomaterials accumulate in the sediment. The early investigation of the potential of nanomaterials to bioaccumulate in sediment-living and filter-feeding organisms is fundamental. Therefore, aim of the project is to develop an appropriate approach to test the bioaccumulation of nanomaterials. For this aim, the bioaccumulative potential of nanomaterials of differing chemical nature in mussels is investigated taking into account adaptations needed to reliable investigate the bioaccumulation of nanomaterials in filtering invertebrates. (UFORDAT Nr. 01064071)
Grouping of nanomaterials for a joint assessment of environmental fate and effects for regulatory purposes
Based on the variety of existing nanomaterials with numerous modifications, the effort of investigating environmental fate and effects will be tremendous. Hence, it will be necessary to group nanomaterials which feature similar fate and effects. The project aims to correlate physical-chemical data with ecotoxicological effects for selected nanomaterials and tries to define reference values which can serve as a basis for grouping. This grouping based on physical-chemical parameters will be examined by OECD standardized tests methods using algae, daphnia and fish embryo (OECD TG 201, 202, 236) and will be modified and refined on this basis.
(UFORDAT Nr. 01051534)
Review of methodological problematic issues regarding the examination of nanomaterials in the environment – Development of a decision support tool for the investigation of environmental behavior of nanomaterials on the basis of their dispersion stability and solubility as a function of environmental conditions
For an adequate and valid interpretation of data regarding the environmental fate and behavior of nanomaterials it is essential to be able to describe parameters like dissolution, dispersibility and dispersion stability. Aim of the project is the development of a tiered approach for the investigation of dissolution, dispersion and dispersion behavior of nanomaterials as a prerequisite for continuing studies on environmental behavior. The work of this project is intended to provide basis information for an OECD Guidance Document for the investigation of environmental fate of nanomaterials in aquatic media. In addition to that a draft for a new OECD Test Guideline will be developed for the examination of dispersion stability and behavior of nanomaterials in aquatic media. For this aim influencing factors have to be identified and valid, as well as pragmatic approaches for suitable methods and techniques have to be developed.
(UFORDAT Nr. 01046737)
UBA's involvement in third-party funded projects
DENANA - "Design criteria for sustainable nanomaterials"
The focus of the joint project DENANA is the design of sustainable nanomaterials. For this aim certain design criteria are deduced which are intended to allow the development of non-hazardous nanomaterials. The deduction of these criteria will mainly be based on environmental behaviour and long term ecotoxicity of nanomaterials with commercial relevance, i. e., SiO2, CeO2 and Ag.
Within DENENA, research at the Federal Environment Agency (UBA) comprises the investigation of nanomaterial stability in aqueous solutions under consideration of varying hydro-chemical conditions. In addition, the resulting transport behaviour in water saturated, sandy sediments will be examined with emphasis on CeO2. A special focus is put on the influence of particle coatings. Furthermore, UBA investigates the acute and long term ecotoxic effects of nanomaterials with varying physico-chemical properties. Next to basic ecotoxicological data, results from test designs and long term tests specifically adapted to the exploration of nanomaterials are generated in order to support the development of non-hazardous nanomaterials. Finally, UBA will act as interface for the OECD Working Party on Manufactured Nanomaterials and regulatory activities. Together with the consortia, data and design criteria generated within the DENANA project will be evaluated with respect to their usability for hazard and risk assessment.
DENANA - project website
BMBF NanoGRAVUR – „nanostructured materials – Grouping regarding worker, consumer, and environment safety and risk mitigation“
Nanotechnology opens a multiplicity of new applications in different industrial sectors (e.g. chemical industry, electro technology, medicine). The challenge thereby is the optimal use of the potentiasl of this partially new technology together with a responsible handling. Due to the multiplicity of existing manufactured nanomaterials, which at the same time can be available in different modifications (differences in size, geometry, chemical composition and surface modification), the experimental effort to investigate behaviour and effects for regulatory purposes is enormous. Due to the variety of possible effects it is furthermore impossible to test the potential risk of each nanomaterial individually. For a strategic testing there is a urgent need to group nanomaterials with similar behaviour and effect. Therefore common and quantifiable properties have to be identified which can be used to derive certain behaviour and effects and which can serve as basis for a grouping of different nanomaterials. Due to this complex picture the central aim of nanoGRAVUR is to develop criteria catalogues for a grouping of nanomaterials regarding hazard and risk potentials related to different subjects of protection. UBA is involved in different work packages which inter alia address environmental aspects. Furthermore, UBA interlinks the project to current activities of the OECD Working Party of Manufactured Nanomaterials and current discussions on regulation of nanomaterials.
NanoGRAVUR – project website
Beyond UBA accompany further projects in a in a consultative manner:
BMBF NanoMobil - Synthetic Silver Nanoparticles in the system Soil-Groundwater - mobility, effects on cohabitation and interaction between hydro-, pedo- and biosphere
BMBF NanoUmwelt - Risk analysis of engineered nanomaterials in the environment: identification, quantification and analysis of the human- and ecotoxicological effects
EU Horizon 2020 NanoFaSe- „Nanomaterial Fate and Specification in the Environment“
Finalised third-party funded projects
„UMSICHT″ – Assessment of the environmental hazards of silver nanomaterials: From chemical particles to technical products (2010-2013). The project, funded under the German Ministry of Education and Research (BMBF) NanoNature Program, aimed to generate basic data about the behavior, fate and effect of silver nanomaterials in order to detect possible environmental risks. UBA was one of 16 project partners and carried out standardized eco-toxicological tests as well as analyzed the anti-microbial effect of textiles coated with silver nanomaterials and how such products age under real wearing conditions. Based on the data generated with respect to the properties, environmental behavior and effects of one specific silver nanomaterial as well as based on the development of an exposure scenario for nanosilver released from textiles used for domestic purposes, a risk assessment for silver nanomaterials in consumer goods was carried out. The project was coordinated by the UFT of the University of Bremen.
Final report of the partner UBA (available in German only)
EU Horizon 2020 ProSafe – “Promoting the Implementation of Safe Design”
01.02.2015 - 30.04.2017
Aim of the EU funded “Coordination and Support Action” was to develop a network between different initiatives, institutions and research projects to consolidate their results and knowledge about chemical safety with focus on manufactured nanomaterials. Within the project, data of regulatory relevance regarding e.g. physical-chemical characterisation, behaviour, (eco-)toxicology, exposure as well as life cycle aspects were brought together. In addition, measures and developments on risk assessment, risk management and governance were supported and coordinated. Therefore, different stakeholders of as many as possible EU and non-EU countries were involved. The task of UBA within the project was the organisation of a three day final conference as central event of the project. At this conference the results of different EU funded projects and international activities on the research on nanomaterials safety were presented and discussed in relation to their benefit for regulatory purposes.
Prosafe- project website
The results of the project can be found at the ProSafe Results Repository.
At this page the report of the scientific conference is deposited.