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Veröffentlichung Nanopharmaceuticals - tiny challenges for the environmental risk assessment of pharmaceuticals(2015) Berkner, Silvia; Schwirn, Kathrin; Völker, DorisMany new developments and innovations in health care are based on nanotechnology. The field of nanopharmaceuticals is diverse and not as new as one might think; indeed, nanopharmaceuticals have been marketed for many years, and the future is likely to bring more nanosized compounds to the market. Therefore, it is time to examine whether the environmental risk assessment for human pharmaceuticals is prepared to assess the exposure, fate, and effects of nanopharmaceuticals in an adequate way. Challenges include the different definitions for nanomaterials and nanopharmaceuticals, different regulatory frameworks, the diversity of nanopharmaceuticals, the scope of current regulatory guidelines, and the applicability of test protocols. Based on the current environmental risk assessment for human medicinal products in the European Union, necessary adaptations for the assessment procedures and underlying study protocols are discussed and emerging solutions identified. Environ Toxicol Chem 2015;9999:1-8. © 2015 The Authors. Environmental Toxicology & Chemistry published by Wiley Periodicals, Inc. on behalf of SETAC.Veröffentlichung Kleinste Teilchen - große Herausforderung(2018) Schwirn, Kathrin; Völker, DorisDie Nanoskaligkeit eines Stoffes allein ist nicht zwangsläufig gleichbedeutend mit einem Risiko für die Umwelt. Allerdings weisen Nanomaterialien spezifische Eigenschaften auf, die sie von konventionellen, leicht löslichen organischen Chemikalien unterscheiden. Dies muss bei der Umweltrisikobewertung berücksichtigt werden. Was ist erforderlich für eine angemessene Bewertung der Gefahren und der Regulierung? In: umwelt aktuell : Infodienst für europäische und deutsche Umweltpolitik / Deutscher Naturschutzring Herausgeber/in. - (2018), Heft 3, 1 Onlineressource (Seite 8)Veröffentlichung Hazard grouping of nanomaterials for daphnia and algae toxicity: lessons learned from scientific projects for regulatory applicability(2019) Schwirn, Kathrin; Völker, DorisGiven the numerous manufactured nanomaterials already on the market and expected in future, the effort for the individual investigation of hazard and risk would be enormous. To overcome this challenge, grouping of nanomaterials has been identified as one critical issue by the European Commission as well as the Organisation for Economic Co-operation and Development (OECD). In that context, several research projects have been carried out to deliver scientific input and develop approaches. This publication discusses experiences from several cases of two scientific projects with the aims to develop and review analogy hypotheses for grouping of different nanoforms of same substances for endpoints related to aquatic ecotoxicity from a regulatory point of view. Furthermore, by presenting examples of grouping attempts, it outlines the need for considerations of further aspects beside key physicalâ€Ìchemical parameters for grouping nanomaterials regarding environmental endpoints. The results substantiate previous educated guesses with strategically collected experimental data on issues that needs to be considered for grouping nanomaterials in regulatory context. Still, grouping of nanomaterials for the aim of joint assessment of ecotoxicity of nanoforms in a regulatory context is in its infants compared to grouping approaches of nanoforms for human health assessment. This publication features important aspects on possibilities and challenges of grouping nanomaterials for environmental hazard assessment. Quelle: https://enveurope.springeropen.comVeröffentlichung Internationale Umwelt- und Nachhaltigkeitspolitik während und nach der Covid-19-Pandemie(2020) Ginzky, Harald; Kosmol, Jan; Schwirn, KathrinVeröffentlichung Internationale Umwelt- und Nachhaltigkeitspolitik während und nach der Covid-19 Pandemie(2020) Ginzky, Harald; Kosmol, Jan; Schwirn, KathrinVeröffentlichung Environmental risk assessment of nanomaterials in the light of new obligations under the REACH regulation: which challenges remain and how to approach them?(2020) Schwirn, Kathrin; Galert, Wiebke; Völker, DorisWithin the European regulation on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH, EC No 1907/2006) specific provisions for nanomaterials were included, which have become effective on 1 January 2020. Although knowledge on the peculiarities of testing and assessing fate and effects of nanomaterials in the environment strongly increased in the last years, uncertainties about how to perform a reliable and robust environmental risk assessment for nanomaterials still remain. These uncertainties are of special relevance in a regulatory context, challenging both industry and regulators. The present paper presents current challenges in regulatory hazard and exposure assessment under REACH, as well as classification of nanomaterials, and makes proposals to address them. Still, the nanospecific considerations made here are expected to also be valid for environmental risk assessment approaches in other regulations of chemical safety. Inter alia, these proposals include a way forward to account for exposure concentrations in aquatic toxicity test systems, a discussion of how to account for availability of dissolving nanomaterials in aquatic test systems, and a pragmatic proposal to deduce effect data for soil organisms. Furthermore, it specifies how to potentially deal with nanoforms under the European regulation on Classification, Labelling and Packaging of substances and mixtures (CLP) and outlines the needs for proper exposure assessments of nanomaterials from a regulatory perspective. Integr Environ Assess Manag 2020;16:706-717. © 2020 The Authors.Veröffentlichung Testing the bioaccumulation of manufactured nanomaterials in the freshwater bivalve Corbicula fluminea using a new test method(2020) Kühr, Sebastian; Meisterjahn, Boris; Schröder, Nicola; Völker, Doris; Schwirn, KathrinIncreasing amounts of manufactured nanomaterials (MNMs) are produced for their industrial use and released to the environment by the usage or disposal of the products. As depending on their annual production rate, substances are subjected to PBT assessment, the availability of reliable methods to evaluate these endpoints for (corresponding) nanoforms/MNMs becomes relevant. The classical method to elucidate the bioaccumulation potential of chemicals has been the flow-through study with fish, which has limitations as regards meeting the requirements of MNMs. Most MNMs tend to sediment in the aquatic environment. Thus, maintenance of stable exposure conditions for bioaccumulation testing with fish is nearly impossible to achieve when using MNMs. Corbicula fluminea, a freshwater filter-feeding bivalve distributed worldwide, has been previously shown to ingest and accumulate MNMs present in the water phase. To investigate the suitability of C. fluminea for bioaccumulation testing we developed a new flow-through system to expose mussels under constant exposure conditions. Two nanoparticles (NPs), the AgNP NM 300K and the TiO2NP NM 105, were applied. In addition, C. fluminea was exposed to AgNO3 as a source of dissolved Ag+ to compare the bioaccumulation of Ag in dissolved and nanoparticulate forms. For each MNM exposure scenario we were able to determine steady-state bioaccumulation factors. BAFss values of 31 and 128 for two NM 300K concentrations (0.624 and 6.177 (my)g Ag per L) and 6150 and 9022 for TiO2 (0.099 and 0.589 (my)g TiO2 per L) showed the exposure dependence of the BAFss estimates. The progression of metal uptake and elimination in the soft tissue provided clear indications that the uptake and thus accumulation is mainly driven by the uptake of NPs and less of dissolved ions. © The Royal Society of ChemistryVeröffentlichung Too advanced for assessment? Advanced materials, nanomedicine and the environment(2022) Berkner, Silvia; Schwirn, Kathrin; Völker, DorisAdvanced materials, and nanomaterials, are promising for healthcare applications and are in particular in the spotlight of medical innovation since rapidly developed nano-formulated vaccines provide relief in the SARS-CoV-2 pandemic. Further increased rapid growth is to be expected as more and more products are in development and reach the market, beneficial for human health. However, the human body is not a dead end and these products are likely to enter the environment, whereas their fate and effects in the environment are unknown. This part of the life-cycle of advanced medicinal products tends to be overlooked, if the perspective is human-centered and excludes the connectedness of human activity with, and consequences for our environment. Gaps are reviewed that exist in awareness, perspective taking, inclusion of environmental concerns into research and product development and also in available methodologies and regulatory guidance. To bridge these gaps, possible ways forward start to emerge, that could help to find a more integrative way of assessing human and environmental safety for advanced material medicinal products and nanomedicines. © The Author(s) 2022.Veröffentlichung Towards harmonisation of testing of nanomaterials for EU regulatory requirements on chemical safety - a proposal for further actions(2023) Bleeker, Eric A.J.; Swart, Elmer; Braakhuis, Hedwig; Schwirn, KathrinOver the recent years, EU chemicals legislation, guidance and test guidelines have been developed or adapted for nanomaterials to facilitate safe use of nanomaterials. This paper provides an overview of the information requirements across different EU regulatory areas. For each information requirement, a group of 22 experts identified potential needs for further action to accommodate guidance and test guidelines to nanomaterials. Eleven different needs for action were identified, capturing twenty-two information requirements that are specific to nanomaterials and relevant to multiple regulatory areas. These were further reduced to three overarching issues: 1) resolve issues around nanomaterial dispersion stability and dosing in toxicity testing, in particular for human health endpoints, 2) further develop tests or guidance on degradation and transformation of organic nanomaterials or nanomaterials with organic components, and 3) further develop tests and guidance to measure (a)cellular reactivity of nanomaterials. Efforts towards addressing these issues will result in better fit-for-purpose test methods for (EU) regulatory compliance. Moreover, it secures validity of hazard and risk assessments of nanomaterials. The results of the study accentuate the need for a structural process of identification of information needs and knowledge generation, preferably as part of risk governance and closely connected to technological innovation policy. © 2023 The Authors