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Dr. Danail Hristozov
University Ca' Foscari of Venice, Greendecision Srl., EMERGE Ltd.

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0 Chemicals
0 Nanomaterials
0 Sustainability
0 Risk Assessment and Management
0 Decision analysis and evaluation

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Nanomaterials
Risk Assessment and Management
Decision analysis and evaluation
Sustainability
Chemicals

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Journal article
Published: 13 October 2020 in Materials
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The convergence of nanotechnology and biotechnology has led to substantial advancements in nano-biomaterials (NBMs) used in medical devices (MD) and advanced therapy medicinal products (ATMP). However, there are concerns that applications of NBMs for medical diagnostics, therapeutics and regenerative medicine could also pose health and/or environmental risks since the current understanding of their safety is incomplete. A scientific strategy is therefore needed to assess all risks emerging along the life cycles of these products. To address this need, an overarching risk management framework (RMF) for NBMs used in MD and ATMP is presented in this paper, as a result of a collaborative effort of a team of experts within the EU Project BIORIMA and with relevant inputs from external stakeholders. The framework, in line with current regulatory requirements, is designed according to state-of-the-art approaches to risk assessment and management of both nanomaterials and biomaterials. The collection/generation of data for NBMs safety assessment is based on innovative integrated approaches to testing and assessment (IATA). The framework can support stakeholders (e.g., manufacturers, regulators, consultants) in systematically assessing not only patient safety but also occupational (including healthcare workers) and environmental risks along the life cycle of MD and ATMP. The outputs of the framework enable the user to identify suitable safe(r)-by-design alternatives and/or risk management measures and to compare the risks of NBMs to their (clinical) benefits, based on efficacy, quality and cost criteria, in order to inform robust risk management decision-making.

ACS Style

Elisa Giubilato; Virginia Cazzagon; Mónica J. B. Amorim; Magda Blosi; Jacques Bouillard; Hans Bouwmeester; Anna Luisa Costa; Bengt Fadeel; Teresa F. Fernandes; Carlos Fito; Marina Hauser; Antonio Marcomini; Bernd Nowack; Lisa Pizzol; Leagh Powell; Adriele Prina-Mello; Haralambos Sarimveis; Janeck James Scott-Fordsmand; Elena Semenzin; Burkhard Stahlmecke; Vicki Stone; Alexis Vignes; Terry Wilkins; Alex Zabeo; Lang Tran; Danail Hristozov. Risk Management Framework for Nano-Biomaterials Used in Medical Devices and Advanced Therapy Medicinal Products. Materials 2020, 13, 4532 .

AMA Style

Elisa Giubilato, Virginia Cazzagon, Mónica J. B. Amorim, Magda Blosi, Jacques Bouillard, Hans Bouwmeester, Anna Luisa Costa, Bengt Fadeel, Teresa F. Fernandes, Carlos Fito, Marina Hauser, Antonio Marcomini, Bernd Nowack, Lisa Pizzol, Leagh Powell, Adriele Prina-Mello, Haralambos Sarimveis, Janeck James Scott-Fordsmand, Elena Semenzin, Burkhard Stahlmecke, Vicki Stone, Alexis Vignes, Terry Wilkins, Alex Zabeo, Lang Tran, Danail Hristozov. Risk Management Framework for Nano-Biomaterials Used in Medical Devices and Advanced Therapy Medicinal Products. Materials. 2020; 13 (20):4532.

Chicago/Turabian Style

Elisa Giubilato; Virginia Cazzagon; Mónica J. B. Amorim; Magda Blosi; Jacques Bouillard; Hans Bouwmeester; Anna Luisa Costa; Bengt Fadeel; Teresa F. Fernandes; Carlos Fito; Marina Hauser; Antonio Marcomini; Bernd Nowack; Lisa Pizzol; Leagh Powell; Adriele Prina-Mello; Haralambos Sarimveis; Janeck James Scott-Fordsmand; Elena Semenzin; Burkhard Stahlmecke; Vicki Stone; Alexis Vignes; Terry Wilkins; Alex Zabeo; Lang Tran; Danail Hristozov. 2020. "Risk Management Framework for Nano-Biomaterials Used in Medical Devices and Advanced Therapy Medicinal Products." Materials 13, no. 20: 4532.

Journal article
Published: 01 August 2018 in Nano Today
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As the use of manufactured nanomaterials continues to grow internationally, policymakers, regulators, and key stakeholders in industry need to foster governance for such materials and their resulting products. Various stakeholders in government and industry have traditionally employed risk assessment quantifying material hazard, exposure, and effects assessments based upon available measurable data to derive safe exposure limits and acceptable environmental releases. This approach forms the foundation of risk-based governance. However, where manufactured nanomaterials do not have robust quantitative data to populate models for evaluation of hazard, exposure and effects, an alternative set of tools is needed for nanomaterial governance. One option is governance using holistic, multi-criteria approaches, which comparatively review risks, benefits, and other implications of nano-enabled products against conventional alternatives. Such multi-criteria approaches are in line with recent calls for research by the European Commission, and are increasingly discussed in scholarly literature. Based upon the needs and legal/regulatory requirements of a given stakeholder, risk-based or multi-criteria tools can help inform nanomaterial assessment and decision making.

ACS Style

Benjamin D. Trump; Danail Hristozov; Timothy Malloy; Igor Linkov. Risk associated with engineered nanomaterials: Different tools for different ways to govern. Nano Today 2018, 21, 9 -13.

AMA Style

Benjamin D. Trump, Danail Hristozov, Timothy Malloy, Igor Linkov. Risk associated with engineered nanomaterials: Different tools for different ways to govern. Nano Today. 2018; 21 ():9-13.

Chicago/Turabian Style

Benjamin D. Trump; Danail Hristozov; Timothy Malloy; Igor Linkov. 2018. "Risk associated with engineered nanomaterials: Different tools for different ways to govern." Nano Today 21, no. : 9-13.

Editorial
Published: 15 May 2018 in Environment Systems and Decisions
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ACS Style

Benjamin D. Trump; Danail Hristozov; Igor Linkov. An introduction to Environment Systems and Decisions’ Special Issue on Emerging Technologies. Environment Systems and Decisions 2018, 38, 161 -162.

AMA Style

Benjamin D. Trump, Danail Hristozov, Igor Linkov. An introduction to Environment Systems and Decisions’ Special Issue on Emerging Technologies. Environment Systems and Decisions. 2018; 38 (2):161-162.

Chicago/Turabian Style

Benjamin D. Trump; Danail Hristozov; Igor Linkov. 2018. "An introduction to Environment Systems and Decisions’ Special Issue on Emerging Technologies." Environment Systems and Decisions 38, no. 2: 161-162.

Research article
Published: 27 January 2018 in Environmental Science & Technology
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Nanoenabled products (NEPs) have numerous outdoor uses in construction, transportation or consumer scenarios, and there is evidence that their fragments are released in the environment at low rates. We hypothesized that the lower surface availability of NEPs fragment reduced their environmental effects with respect to pristine nanomaterials. This hypothesis was explored by testing fragments generated by intentional micronisation (“the SUN approach”; Nowack et al. Meeting the Needs for Released Nanomaterials Required for Further Testing: The SUN Approach. Environmental Science & Technology, 2016 (50), 2747). The NEPs were composed of four matrices (epoxy, polyolefin, polyoxymethylene, and cement) with up to 5% content of three nanomaterials (carbon nanotubes, iron oxide, and organic pigment). Regardless of the type of nanomaterial or matrix used, it was observed that nanomaterials were only partially exposed at the NEP fragment surface, indicating that mostly the intrinsic and extrinsic properties of the matrix drove the NEP fragment toxicity. Ecotoxicity in multiple assays was done covering relevant media from terrestrial to aquatic, including sewage treatment plant (biological activity), soil worms (Enchytraeus crypticus), and fish (zebrafish embryo and larvae and trout cell lines). We designed the studies to explore the possible modulation of ecotoxicity by nanomaterial additives in plastics/polymer/cement, finding none. The results support NEPs grouping by the matrix material regarding ecotoxicological effect during the use phase. Furthermore, control results on nanomaterial-free polymer fragments representing microplastic had no significant adverse effects up to the highest concentration tested.

ACS Style

Mónica J.B. Amorim; Sijie Lin; Karsten Schlich; José M. Navas; Andrea Brunelli; Nicole Neubauer; Klaus Vilsmeier; Anna L. Costa; Andreas Gondikas; Tian Xia; Liliana Galbis; Elena Badetti; Antonio Marcomini; Danail Hristozov; Frank von der Kammer; Kerstin Hund-Rinke; Janeck J. Scott-Fordsmand; André Nel; Wendel Wohlleben. Environmental Impacts by Fragments Released from Nanoenabled Products: A Multiassay, Multimaterial Exploration by the SUN Approach. Environmental Science & Technology 2018, 52, 1514 -1524.

AMA Style

Mónica J.B. Amorim, Sijie Lin, Karsten Schlich, José M. Navas, Andrea Brunelli, Nicole Neubauer, Klaus Vilsmeier, Anna L. Costa, Andreas Gondikas, Tian Xia, Liliana Galbis, Elena Badetti, Antonio Marcomini, Danail Hristozov, Frank von der Kammer, Kerstin Hund-Rinke, Janeck J. Scott-Fordsmand, André Nel, Wendel Wohlleben. Environmental Impacts by Fragments Released from Nanoenabled Products: A Multiassay, Multimaterial Exploration by the SUN Approach. Environmental Science & Technology. 2018; 52 (3):1514-1524.

Chicago/Turabian Style

Mónica J.B. Amorim; Sijie Lin; Karsten Schlich; José M. Navas; Andrea Brunelli; Nicole Neubauer; Klaus Vilsmeier; Anna L. Costa; Andreas Gondikas; Tian Xia; Liliana Galbis; Elena Badetti; Antonio Marcomini; Danail Hristozov; Frank von der Kammer; Kerstin Hund-Rinke; Janeck J. Scott-Fordsmand; André Nel; Wendel Wohlleben. 2018. "Environmental Impacts by Fragments Released from Nanoenabled Products: A Multiassay, Multimaterial Exploration by the SUN Approach." Environmental Science & Technology 52, no. 3: 1514-1524.

Perspective
Published: 14 December 2017 in Risk Analysis
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Societies worldwide are investing considerable resources into the safe development and use of nanomaterials. Although each of these protective efforts is crucial for governing the risks of nanomaterials, they are insufficient in isolation. What is missing is a more integrative governance approach that goes beyond legislation. Development of this approach must be evidence based and involve key stakeholders to ensure acceptance by end users. The challenge is to develop a framework that coordinates the variety of actors involved in nanotechnology and civil society to facilitate consideration of the complex issues that occur in this rapidly evolving research and development area. Here, we propose three sets of essential elements required to generate an effective risk governance framework for nanomaterials. (1) Advanced tools to facilitate risk‐based decision making, including an assessment of the needs of users regarding risk assessment, mitigation, and transfer. (2) An integrated model of predicted human behavior and decision making concerning nanomaterial risks. (3) Legal and other (nano‐specific and general) regulatory requirements to ensure compliance and to stimulate proactive approaches to safety. The implementation of such an approach should facilitate and motivate good practice for the various stakeholders to allow the safe and sustainable future development of nanotechnology.

ACS Style

Vicki Stone; Martin Führ; Peter H. Feindt; Hans Bouwmeester; Igor Linkov; Stefania Sabella; Finbarr Murphy; Kilian Bizer; Lang Tran; Marlene Ågerstrand; Carlos Fito-López; Torben Andersen; Diana Anderson; Enrico Bergamaschi; John W. Cherrie; Sue Cowan; Jean-Francois Dalemcourt; Michael Faure; Silke Gabbert; Agnieszka Gajewicz-Skretna; Teresa Fernandes; Danail Hristozov; Helinor J. Johnston; Terry C. Lansdown; Stefan Linder; Hans J. P. Marvin; Martin Mullins; Kai Purnhagen; Tomasz Puzyn; Araceli Sanchez Jimenez; Janeck Scott-Fordsmand; George Streftaris; Martie van Tongeren; Nicolas Voelcker; George Voyiatzis; Spyros N. Yannopoulos; P. Marijn Poortvliet. The Essential Elements of a Risk Governance Framework for Current and Future Nanotechnologies. Risk Analysis 2017, 38, 1321 -1331.

AMA Style

Vicki Stone, Martin Führ, Peter H. Feindt, Hans Bouwmeester, Igor Linkov, Stefania Sabella, Finbarr Murphy, Kilian Bizer, Lang Tran, Marlene Ågerstrand, Carlos Fito-López, Torben Andersen, Diana Anderson, Enrico Bergamaschi, John W. Cherrie, Sue Cowan, Jean-Francois Dalemcourt, Michael Faure, Silke Gabbert, Agnieszka Gajewicz-Skretna, Teresa Fernandes, Danail Hristozov, Helinor J. Johnston, Terry C. Lansdown, Stefan Linder, Hans J. P. Marvin, Martin Mullins, Kai Purnhagen, Tomasz Puzyn, Araceli Sanchez Jimenez, Janeck Scott-Fordsmand, George Streftaris, Martie van Tongeren, Nicolas Voelcker, George Voyiatzis, Spyros N. Yannopoulos, P. Marijn Poortvliet. The Essential Elements of a Risk Governance Framework for Current and Future Nanotechnologies. Risk Analysis. 2017; 38 (7):1321-1331.

Chicago/Turabian Style

Vicki Stone; Martin Führ; Peter H. Feindt; Hans Bouwmeester; Igor Linkov; Stefania Sabella; Finbarr Murphy; Kilian Bizer; Lang Tran; Marlene Ågerstrand; Carlos Fito-López; Torben Andersen; Diana Anderson; Enrico Bergamaschi; John W. Cherrie; Sue Cowan; Jean-Francois Dalemcourt; Michael Faure; Silke Gabbert; Agnieszka Gajewicz-Skretna; Teresa Fernandes; Danail Hristozov; Helinor J. Johnston; Terry C. Lansdown; Stefan Linder; Hans J. P. Marvin; Martin Mullins; Kai Purnhagen; Tomasz Puzyn; Araceli Sanchez Jimenez; Janeck Scott-Fordsmand; George Streftaris; Martie van Tongeren; Nicolas Voelcker; George Voyiatzis; Spyros N. Yannopoulos; P. Marijn Poortvliet. 2017. "The Essential Elements of a Risk Governance Framework for Current and Future Nanotechnologies." Risk Analysis 38, no. 7: 1321-1331.

Journal article
Published: 19 October 2017 in International Journal of Environmental Research and Public Health
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An Environmental Risk Assessment (ERA) for nanomaterials (NMs) is outlined in this paper. Contrary to other recent papers on the subject, the main data requirements, models and advancement within each of the four risk assessment domains are described, i.e., in the: (i) materials, (ii) release, fate and exposure, (iii) hazard and (iv) risk characterisation domains. The material, which is obviously the foundation for any risk assessment, should be described according to the legislatively required characterisation data. Characterisation data will also be used at various levels within the ERA, e.g., exposure modelling. The release, fate and exposure data and models cover the input for environmental distribution models in order to identify the potential (PES) and relevant exposure scenarios (RES) and, subsequently, the possible release routes, both with regard to which compartment(s) NMs are distributed in line with the factors determining the fate within environmental compartment. The initial outcome in the risk characterisation will be a generic Predicted Environmental Concentration (PEC), but a refined PEC can be obtained by applying specific exposure models for relevant media. The hazard information covers a variety of representative, relevant and reliable organisms and/or functions, relevant for the RES and enabling a hazard characterisation. The initial outcome will be hazard characterisation in test systems allowing estimating a Predicted No-Effect concentration (PNEC), either based on uncertainty factors or on a NM adapted version of the Species Sensitivity Distributions approach. The risk characterisation will either be based on a deterministic risk ratio approach (i.e., PEC/PNEC) or an overlay of probability distributions, i.e., exposure and hazard distributions, using the nano relevant models.

ACS Style

Janeck J. Scott‐Fordsmand; Willie J. G. M. Peijnenburg; Elena Semenzin; Bernd Nowack; Neil Hunt; Danail Hristozov; Antonio Marcomini; Muhammad‐Adeel Irfan; Araceli Sánchez Jiménez; Robert Landsiedel; Lang Tran; Agnes G. Oomen; Peter M. J. Bos; Kerstin Hund‐Rinke. Environmental Risk Assessment Strategy for Nanomaterials. International Journal of Environmental Research and Public Health 2017, 14, 1251 .

AMA Style

Janeck J. Scott‐Fordsmand, Willie J. G. M. Peijnenburg, Elena Semenzin, Bernd Nowack, Neil Hunt, Danail Hristozov, Antonio Marcomini, Muhammad‐Adeel Irfan, Araceli Sánchez Jiménez, Robert Landsiedel, Lang Tran, Agnes G. Oomen, Peter M. J. Bos, Kerstin Hund‐Rinke. Environmental Risk Assessment Strategy for Nanomaterials. International Journal of Environmental Research and Public Health. 2017; 14 (10):1251.

Chicago/Turabian Style

Janeck J. Scott‐Fordsmand; Willie J. G. M. Peijnenburg; Elena Semenzin; Bernd Nowack; Neil Hunt; Danail Hristozov; Antonio Marcomini; Muhammad‐Adeel Irfan; Araceli Sánchez Jiménez; Robert Landsiedel; Lang Tran; Agnes G. Oomen; Peter M. J. Bos; Kerstin Hund‐Rinke. 2017. "Environmental Risk Assessment Strategy for Nanomaterials." International Journal of Environmental Research and Public Health 14, no. 10: 1251.

Journal article
Published: 01 October 2017 in NanoImpact
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ACS Style

Ana Ribeiro; Paulo Emilio Leite; P. Falagan-Lotsch; Federico Benetti; C. Micheletti; H.C. Budtz; Nicklas Raun Jacobsen; Paulo Lisboa-Filho; Luís Rocha; D. Kühnel; Danail Hristozov; Jose Granjeiro. Challenges on the toxicological predictions of engineered nanoparticles. NanoImpact 2017, 8, 59 -72.

AMA Style

Ana Ribeiro, Paulo Emilio Leite, P. Falagan-Lotsch, Federico Benetti, C. Micheletti, H.C. Budtz, Nicklas Raun Jacobsen, Paulo Lisboa-Filho, Luís Rocha, D. Kühnel, Danail Hristozov, Jose Granjeiro. Challenges on the toxicological predictions of engineered nanoparticles. NanoImpact. 2017; 8 ():59-72.

Chicago/Turabian Style

Ana Ribeiro; Paulo Emilio Leite; P. Falagan-Lotsch; Federico Benetti; C. Micheletti; H.C. Budtz; Nicklas Raun Jacobsen; Paulo Lisboa-Filho; Luís Rocha; D. Kühnel; Danail Hristozov; Jose Granjeiro. 2017. "Challenges on the toxicological predictions of engineered nanoparticles." NanoImpact 8, no. : 59-72.

Journal article
Published: 01 July 2017 in NanoImpact
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ACS Style

Chengfang Pang; Nicole Neubauer; Matthew Boyles; David Brown; Nilesh Kanase; Danail Hristozov; Teresa Fernandes; Vicki Stone; Wendel Wohlleben; Antonio Marcomini. Releases from transparent blue automobile coatings containing nanoscale copper phthalocyanine and their effects on J774 A1 macrophages. NanoImpact 2017, 7, 75 -83.

AMA Style

Chengfang Pang, Nicole Neubauer, Matthew Boyles, David Brown, Nilesh Kanase, Danail Hristozov, Teresa Fernandes, Vicki Stone, Wendel Wohlleben, Antonio Marcomini. Releases from transparent blue automobile coatings containing nanoscale copper phthalocyanine and their effects on J774 A1 macrophages. NanoImpact. 2017; 7 ():75-83.

Chicago/Turabian Style

Chengfang Pang; Nicole Neubauer; Matthew Boyles; David Brown; Nilesh Kanase; Danail Hristozov; Teresa Fernandes; Vicki Stone; Wendel Wohlleben; Antonio Marcomini. 2017. "Releases from transparent blue automobile coatings containing nanoscale copper phthalocyanine and their effects on J774 A1 macrophages." NanoImpact 7, no. : 75-83.

Article
Published: 17 June 2017 in Environment Systems and Decisions
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Mental modelling analysis can be a valuable tool in understanding and bridging cognitive values in multi-stakeholders’ communities. It is especially true in situation of emerging risks where significant uncertainty and competing objectives could result in significant difference in stakeholder perspective on the use of new materials and technologies. This paper presents a mental modelling study performed among prospective users of an innovative decision support system for safe and sustainable development of nano-enabled products. These users included representatives of industry and regulators, as well as several insurance specialists and researchers. We present methodology and tools for comparing stakeholder views and objectives in the context of developing a decision support system.

ACS Style

Ineke Malsch; Vrishali Subramanian; Elena Semenzin; Alex Zabeo; Danail Hristozov; Martin Mullins; Finbarr Murphy; Igor Linkov; Antonio Marcomini. Comparing mental models of prospective users of the sustainable nanotechnology decision support system. Environment Systems and Decisions 2017, 1 .

AMA Style

Ineke Malsch, Vrishali Subramanian, Elena Semenzin, Alex Zabeo, Danail Hristozov, Martin Mullins, Finbarr Murphy, Igor Linkov, Antonio Marcomini. Comparing mental models of prospective users of the sustainable nanotechnology decision support system. Environment Systems and Decisions. 2017; ():1.

Chicago/Turabian Style

Ineke Malsch; Vrishali Subramanian; Elena Semenzin; Alex Zabeo; Danail Hristozov; Martin Mullins; Finbarr Murphy; Igor Linkov; Antonio Marcomini. 2017. "Comparing mental models of prospective users of the sustainable nanotechnology decision support system." Environment Systems and Decisions , no. : 1.

Societal lca
Published: 15 May 2017 in The International Journal of Life Cycle Assessment
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Assessment of the social aspects of sustainability of products is a topic of significant interest to companies, and several methodologies have been proposed in the recent years. The significant environmental health and safety concerns about nano-enabled products calls for the early establishment of a clear benefit-risk framework in order to decide which novel products should be developed further. This paper proposes a method to assess the social impacts of nano-enabled products through the life cycle that is (a) quantitative, (b) integrates performance and attitudinal dimensions of social impacts and (c) considers the overall and stakeholder balance of benefits and costs. Social life cycle assessment (s-LCA) and multi-criteria decision analysis (MCDA) are integrated to address this need, and the method is illustrated on a case study of a nano-enabled product. The s-LCA framework comprises 15 indicators to characterize the social context of the product manufacture placed within the classification structure of benefit/cost and worker/community. The methodology includes four steps: (a) normalization of company level data on the social indicator to country level data for the year, (b) nested weighting at stakeholder and indicator level and its integration with normalized scores to create social indicator scores, (c) aggregation of social indicator scores into benefit score, cost score and net benefit scores as per the s-LCA framework and (d) classification of social indicator scores and aggregated scores as low/medium/high based on benchmarks created using employment and value-added proxies. A prospective production scenario involving novel product, a nano-copper oxide (n-CuO)-based paint with biocidal functionality, is assessed with respect to its social impacts. The method was applied to 12 indicators at the company level. Classification of social indicator scores and aggregated scores showed that the n-CuO paint has high net benefits. The framework and method offer a flexible structure that can be revised and extended as more knowledge and data on social impacts of nano-enabled products becomes available. The proposed method is being implemented in the social impact assessment sub-module of the SUN Decision Support (SUNDS) software system. Companies seeking to improve the social footprint of their products can also use the proposed method to consider relevant social impacts to achieve this goal.

ACS Style

Vrishali Subramanian; Elena Semenzin; Alex Zabeo; Peter Saling; Tom Ligthart; Toon Van Harmelen; Ineke Malsch; Danail Hristozov; Antonio Marcomini. Assessing the social impacts of nano-enabled products through the life cycle: the case of nano-enabled biocidal paint. The International Journal of Life Cycle Assessment 2017, 23, 348 -356.

AMA Style

Vrishali Subramanian, Elena Semenzin, Alex Zabeo, Peter Saling, Tom Ligthart, Toon Van Harmelen, Ineke Malsch, Danail Hristozov, Antonio Marcomini. Assessing the social impacts of nano-enabled products through the life cycle: the case of nano-enabled biocidal paint. The International Journal of Life Cycle Assessment. 2017; 23 (2):348-356.

Chicago/Turabian Style

Vrishali Subramanian; Elena Semenzin; Alex Zabeo; Peter Saling; Tom Ligthart; Toon Van Harmelen; Ineke Malsch; Danail Hristozov; Antonio Marcomini. 2017. "Assessing the social impacts of nano-enabled products through the life cycle: the case of nano-enabled biocidal paint." The International Journal of Life Cycle Assessment 23, no. 2: 348-356.

Original article
Published: 21 April 2017 in Nanotoxicology
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The development and use of emerging technologies such as nanomaterials can provide both benefits and risks to society. Emerging materials may promise to bring many technological advantages but may not be well characterized in terms of their production volumes, magnitude of emissions, behaviour in the environment and effects on living organisms. This uncertainty can present challenges to scientists developing these materials and persons responsible for defining and measuring their adverse impacts. Human health risk assessment is a method of identifying the intrinsic hazard of and quantifying the dose–response relationship and exposure to a chemical, to finally determine the estimation of risk. Commonly applied deterministic approaches may not sufficiently estimate and communicate the likelihood of risks from emerging technologies whose uncertainty is large. Probabilistic approaches allow for parameters in the risk assessment process to be defined by distributions instead of single deterministic values whose uncertainty could undermine the value of the assessment. A probabilistic approach was applied to the dose–response and exposure assessment of a case study involving the production of nanoparticles of titanium dioxide in seven different exposure scenarios. Only one exposure scenario showed a statistically significant level of risk. In the latter case, this involved dumping high volumes of nano-TiO2 powders into an open vessel with no personal protection equipment. The probabilistic approach not only provided the likelihood of but also the major contributing factors to the estimated risk (e.g. emission potential).

ACS Style

Michael Tsang; Danail Hristozov; Alex Zabeo; Antti Joonas Koivisto; Alexander Christian Østerskov Jensen; Keld Alstrup Jensen; Chengfang Pang; Antonio Marcomini; Guido Sonnemann. Probabilistic risk assessment of emerging materials: case study of titanium dioxide nanoparticles. Nanotoxicology 2017, 11, 558 -568.

AMA Style

Michael Tsang, Danail Hristozov, Alex Zabeo, Antti Joonas Koivisto, Alexander Christian Østerskov Jensen, Keld Alstrup Jensen, Chengfang Pang, Antonio Marcomini, Guido Sonnemann. Probabilistic risk assessment of emerging materials: case study of titanium dioxide nanoparticles. Nanotoxicology. 2017; 11 (4):558-568.

Chicago/Turabian Style

Michael Tsang; Danail Hristozov; Alex Zabeo; Antti Joonas Koivisto; Alexander Christian Østerskov Jensen; Keld Alstrup Jensen; Chengfang Pang; Antonio Marcomini; Guido Sonnemann. 2017. "Probabilistic risk assessment of emerging materials: case study of titanium dioxide nanoparticles." Nanotoxicology 11, no. 4: 558-568.

Journals
Published: 22 March 2017 in Environmental Science: Nano
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The relationships between the physicochemical properties of engineered nanomaterials (ENMs) and their adverse health and environmental effects are still unclear.

ACS Style

Simona Ortelli; Anna Luisa Costa; Magda Blosi; Andrea Brunelli; Elena Badetti; Alessandro Bonetto; Danail Hristozov; Antonio Marcomini. Colloidal characterization of CuO nanoparticles in biological and environmental media. Environmental Science: Nano 2017, 4, 1264 -1272.

AMA Style

Simona Ortelli, Anna Luisa Costa, Magda Blosi, Andrea Brunelli, Elena Badetti, Alessandro Bonetto, Danail Hristozov, Antonio Marcomini. Colloidal characterization of CuO nanoparticles in biological and environmental media. Environmental Science: Nano. 2017; 4 (6):1264-1272.

Chicago/Turabian Style

Simona Ortelli; Anna Luisa Costa; Magda Blosi; Andrea Brunelli; Elena Badetti; Alessandro Bonetto; Danail Hristozov; Antonio Marcomini. 2017. "Colloidal characterization of CuO nanoparticles in biological and environmental media." Environmental Science: Nano 4, no. 6: 1264-1272.

Review
Published: 01 February 2017 in Environment International
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A critical analysis of the available engineered nanomaterials (ENMs) environmental fate modelling approaches indicates that existing tools do not satisfactorily account for the complexities of nanoscale phenomena. Fractal modelling (FM) can complement existing kinetic fate models by including more accurate interpretations of shape and structure, density and collision efficiency parameters to better describe homo- and heteroaggregation. Pathways to including hierarchical symmetry concepts and a route to establishing a structural classification of nanomaterials based on FM are proposed.

ACS Style

Sviatoslav Avilov; L. Lamon; Danail Hristozov; A. Marcomini. Improving the prediction of environmental fate of engineered nanomaterials by fractal modelling. Environment International 2017, 99, 78 -86.

AMA Style

Sviatoslav Avilov, L. Lamon, Danail Hristozov, A. Marcomini. Improving the prediction of environmental fate of engineered nanomaterials by fractal modelling. Environment International. 2017; 99 ():78-86.

Chicago/Turabian Style

Sviatoslav Avilov; L. Lamon; Danail Hristozov; A. Marcomini. 2017. "Improving the prediction of environmental fate of engineered nanomaterials by fractal modelling." Environment International 99, no. : 78-86.

Journal article
Published: 01 February 2017 in Environment International
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Silver nanoparticles (n-Ag) are widely used in consumer products and many medical applications because of their unique antibacterial properties. Their use is raising concern about potential human exposures and health effects. Therefore, it is informative to assess the potential human health risks of n-Ag in order to ensure that nanotechnology-based consumer products are deployed in a safe and sustainable way. Even though toxicity studies clearly show the potential hazard of n-Ag, there have been few attempts to integrate hazard and exposure assessments to evaluate risks. The underlying reason for this is the difficulty in characterizing exposure and the lack of toxicity studies essential for human health risk assessment (HHRA). Such data gaps introduce significant uncertainty into the risk assessment process. This study uses probabilistic methods to assess the relative uncertainty and potential risks of n-Ag exposure to infants. In this paper, we estimate the risks for infants potentially exposed to n-Ag through drinking juice or milk from sippy cups or licking baby blankets containing n-Ag. We explicitly evaluate uncertainty and variability contained in available dose-response and exposure data in order to make the risk characterization process transparent. Our results showed that individual margin of exposures for oral exposure to sippy cups and baby blankets containing n-Ag exhibited minimal risk.

ACS Style

Chengfang Pang; Danail Hristozov; Alex Zabeo; Lisa Pizzol; Michael P. Tsang; Phil Sayre; Antonio Marcomini. Probabilistic approach for assessing infants' health risks due to ingestion of nanoscale silver released from consumer products. Environment International 2017, 99, 199 -207.

AMA Style

Chengfang Pang, Danail Hristozov, Alex Zabeo, Lisa Pizzol, Michael P. Tsang, Phil Sayre, Antonio Marcomini. Probabilistic approach for assessing infants' health risks due to ingestion of nanoscale silver released from consumer products. Environment International. 2017; 99 ():199-207.

Chicago/Turabian Style

Chengfang Pang; Danail Hristozov; Alex Zabeo; Lisa Pizzol; Michael P. Tsang; Phil Sayre; Antonio Marcomini. 2017. "Probabilistic approach for assessing infants' health risks due to ingestion of nanoscale silver released from consumer products." Environment International 99, no. : 199-207.

Review
Published: 01 October 2016 in Environment International
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Commercialization of nanotechnologies entails a regulatory requirement for understanding their environmental, health and safety (EHS) risks. Today we face challenges to assess these risks, which emerge from uncertainties around the interactions of manufactured nanomaterials (MNs) with humans and the environment. In order to reduce these uncertainties, it is necessary to generate sound scientific data on hazard and exposure by means of relevant frameworks and tools. The development of such approaches to facilitate the risk assessment (RA) of MNs has become a dynamic area of research. The aim of this paper was to review and critically analyse these approaches against a set of relevant criteria. The analysis concluded that none of the reviewed frameworks were able to fulfill all evaluation criteria. Many of the existing modelling tools are designed to provide screening-level assessments rather than to support regulatory RA and risk management. Nevertheless, there is a tendency towards developing more quantitative, higher-tier models, capable of incorporating uncertainty into their analyses. There is also a trend towards developing validated experimental protocols for material identification and hazard testing, reproducible across laboratories. These tools could enable a shift from a costly case-by-case RA of MNs towards a targeted, flexible and efficient process, based on grouping and read-across strategies and compliant with the 3R (Replacement, Reduction, Refinement) principles. In order to facilitate this process, it is important to transform the current efforts on developing databases and computational models into creating an integrated data and tools infrastructure to support the risk assessment and management of MNs.

ACS Style

Danail Hristozov; Stefania Gottardo; Elena Semenzin; Agnes Oomen; Peter Bos; Willie Peijnenburg; Martie van Tongeren; Bernd Nowack; Neil Hunt; Andrea Brunelli; Janeck J. Scott-Fordsmand; Lang Tran; Antonio Marcomini. Frameworks and tools for risk assessment of manufactured nanomaterials. Environment International 2016, 95, 36 -53.

AMA Style

Danail Hristozov, Stefania Gottardo, Elena Semenzin, Agnes Oomen, Peter Bos, Willie Peijnenburg, Martie van Tongeren, Bernd Nowack, Neil Hunt, Andrea Brunelli, Janeck J. Scott-Fordsmand, Lang Tran, Antonio Marcomini. Frameworks and tools for risk assessment of manufactured nanomaterials. Environment International. 2016; 95 ():36-53.

Chicago/Turabian Style

Danail Hristozov; Stefania Gottardo; Elena Semenzin; Agnes Oomen; Peter Bos; Willie Peijnenburg; Martie van Tongeren; Bernd Nowack; Neil Hunt; Andrea Brunelli; Janeck J. Scott-Fordsmand; Lang Tran; Antonio Marcomini. 2016. "Frameworks and tools for risk assessment of manufactured nanomaterials." Environment International 95, no. : 36-53.

Short communication
Published: 11 July 2016 in Nanotoxicology
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Background: The enormous physicochemical and structural diversity of metal oxide nanoparticles (MeONPs) poses significant challenges to the testing of their biological uptake, biodistribution, and effects that can be used to develop understanding of key nano-bio modes of action. This has generated considerable uncertainties in the assessment of their human health and environmental risks and has raised concerns about the adequacy of their regulation. In order to surpass the extremely resource intensive case-by-case testing, intelligent strategies combining testing methods and non-testing predictive modeling should be developed. Methods: The quantitative structure-activity relationship (QSARs) in silico tools can be instrumental in understanding properties that affect the potencies of MeONPs and in predicting toxic responses and thresholds of effects. Results: The present study proposes a predictive nano-QSAR model for predicting the cytotoxicity of MeONPs. The model was applied to test the relationships between 26 physicochemical properties of 51 MeONPs and their cytotoxic effects in Escherichia coli. The two parameters, enthalpy of formation of a gaseous cation (▵Hme+) and polarization force (Z/r), were elucidated to make a significant contribution for the toxic effect of these MeONPs. The study also proposed the mechanisms of toxic potency in E. coli through the model, which indicated that the MeONPs as well as their released metal ions could collectively induce DNA damage and cell apoptosis. Significance: These findings may provide an alternative method for prioritizing current and future MeONPs for potential in vivo testing, virtual prescreening and for designing environmentally benign nanomaterials.

ACS Style

Yunsong Mu; Fengchang Wu; Qing Zhao; Rong Ji; Yu Qie; Yue Zhou; Yan Hu; Chengfang Pang; Danail Hristozov; John P. Giesy; Baoshan Xing. Predicting toxic potencies of metal oxide nanoparticles by means of nano-QSARs. Nanotoxicology 2016, 10, 1207 -1214.

AMA Style

Yunsong Mu, Fengchang Wu, Qing Zhao, Rong Ji, Yu Qie, Yue Zhou, Yan Hu, Chengfang Pang, Danail Hristozov, John P. Giesy, Baoshan Xing. Predicting toxic potencies of metal oxide nanoparticles by means of nano-QSARs. Nanotoxicology. 2016; 10 (9):1207-1214.

Chicago/Turabian Style

Yunsong Mu; Fengchang Wu; Qing Zhao; Rong Ji; Yu Qie; Yue Zhou; Yan Hu; Chengfang Pang; Danail Hristozov; John P. Giesy; Baoshan Xing. 2016. "Predicting toxic potencies of metal oxide nanoparticles by means of nano-QSARs." Nanotoxicology 10, no. 9: 1207-1214.

Research article
Published: 29 June 2016 in Nanotoxicology
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Several tools to facilitate the Risk Assessment and Management of manufactured nanomaterials (MN) have been developed. Most of them require input data on physicochemical properties, toxicity and scenario-specific exposure information. However, such data are yet not readily available, and tools that can handle data gaps in a structured way to ensure transparent risk analysis for industrial and regulatory decision making are needed. This paper proposes such a quantitative risk prioritisation tool, based on a Multi-criteria Decision Analysis algorithm, which combines advanced exposure and dose-response modelling to calculate Margins of Exposure for a number of MN in order to rank their occupational risks. We demonstrated the tool in a number of workplace exposure scenarios involving the production and handling of nanoscale Titanium Dioxide, Zinc Oxide, Silver, and multi-walled carbon nanotubes. The results of this application demonstrated that bag/bin filling, manual un/loading, and dumping of large amounts of dry powders led to high emissions, which resulted in high risk associated with these exposure scenarios. The Zinc Oxide MN revealed considerable hazard potential in vivo, which significantly influenced the risk prioritization results. In order to study how variations in the input data affect our results we performed probabilistic Monte Carlo sensitivity/uncertainty analysis, which demonstrated that the performance of the proposed model is stable against changes in the exposure and hazard input variables.

ACS Style

Danail Hristozov; Alex Zabeo; Keld Alstrup Jensen; Stefania Gottardo; Panagiotis Isigonis; Laura MacCalman; Andrea Critto; Antonio Marcomini. Demonstration of a modelling-based multi-criteria decision analysis procedure for prioritisation of occupational risks from manufactured nanomaterials. Nanotoxicology 2016, 10, 1215 -1228.

AMA Style

Danail Hristozov, Alex Zabeo, Keld Alstrup Jensen, Stefania Gottardo, Panagiotis Isigonis, Laura MacCalman, Andrea Critto, Antonio Marcomini. Demonstration of a modelling-based multi-criteria decision analysis procedure for prioritisation of occupational risks from manufactured nanomaterials. Nanotoxicology. 2016; 10 (9):1215-1228.

Chicago/Turabian Style

Danail Hristozov; Alex Zabeo; Keld Alstrup Jensen; Stefania Gottardo; Panagiotis Isigonis; Laura MacCalman; Andrea Critto; Antonio Marcomini. 2016. "Demonstration of a modelling-based multi-criteria decision analysis procedure for prioritisation of occupational risks from manufactured nanomaterials." Nanotoxicology 10, no. 9: 1215-1228.

Journal article
Published: 21 June 2016 in Environmental Science: Nano
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While the risk management of engineered nanomaterials (ENMS) receives significant attention, there is still a limited understanding of how to select optimal risk management measures for reducing the risks of ENMs.

ACS Style

Ceyda Oksel; Vrishali Subramanian; Elena Semenzin; Cai Yun Ma; Danail Hristozov; Xue Z. Wang; Neil Hunt; Anna Luisa Costa; Wouter Fransman; Antonio Marcomini; Terry Wilkins. Evaluation of existing control measures in reducing health and safety risks of engineered nanomaterials. Environmental Science: Nano 2016, 3, 869 -882.

AMA Style

Ceyda Oksel, Vrishali Subramanian, Elena Semenzin, Cai Yun Ma, Danail Hristozov, Xue Z. Wang, Neil Hunt, Anna Luisa Costa, Wouter Fransman, Antonio Marcomini, Terry Wilkins. Evaluation of existing control measures in reducing health and safety risks of engineered nanomaterials. Environmental Science: Nano. 2016; 3 (4):869-882.

Chicago/Turabian Style

Ceyda Oksel; Vrishali Subramanian; Elena Semenzin; Cai Yun Ma; Danail Hristozov; Xue Z. Wang; Neil Hunt; Anna Luisa Costa; Wouter Fransman; Antonio Marcomini; Terry Wilkins. 2016. "Evaluation of existing control measures in reducing health and safety risks of engineered nanomaterials." Environmental Science: Nano 3, no. 4: 869-882.

Review article
Published: 13 May 2016 in Environmental Science & Technology
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Engineered nanomaterials (ENMs) are increasingly entering the environment with uncertain consequences including potential ecological effects. Various research communities view differently whether ecotoxicological testing of ENMs should be conducted using environmentally relevant concentrations—where observing outcomes is difficult—versus higher ENM doses, where responses are observable. What exposure conditions are typically used in assessing ENM hazards to populations? What conditions are used to test ecosystem-scale hazards? What is known regarding actual ENMs in the environment, via measurements or modeling simulations? How should exposure conditions, ENM transformation, dose, and body burden be used in interpreting biological and computational findings for assessing risks? These questions were addressed in the context of this critical review. As a result, three main recommendations emerged. First, researchers should improve ecotoxicology of ENMs by choosing test endpoints, duration, and study conditions—including ENM test concentrations—that align with realistic exposure scenarios. Second, testing should proceed via tiers with iterative feedback that informs experiments at other levels of biological organization. Finally, environmental realism in ENM hazard assessments should involve greater coordination among ENM quantitative analysts, exposure modelers, and ecotoxicologists, across government, industry, and academia.

ACS Style

Patricia A. Holden; Jorge L. Gardea-Torresdey; Fred Klaessig; Ronald F. Turco; Monika Mortimer; Kerstin Hund-Rinke; Elaine A. Cohen Hubal; David Avery; Damià Barceló; Renata Behra; Yoram Cohen; Laurence Deydier-Stephan; Patrick Lee Ferguson; Teresa F. Fernandes; Barbara Herr Harthorn; William Matthew Henderson; Robert A. Hoke; Danail Hristozov; John M. Johnston; Agnes B. Kane; Larry Kapustka; Arturo A. Keller; Hunter S. Lenihan; Wess Lovell; Catherine J. Murphy; Roger M. Nisbet; Elijah J. Petersen; Edward R. Salinas; Martin Scheringer; Monita Sharma; David E. Speed; Yasir Sultan; Paul Westerhoff; Jason C. White; Mark R. Wiesner; Eva M. Wong; Baoshan Xing; Meghan Steele Horan; Hilary A. Godwin; André E. Nel. Considerations of Environmentally Relevant Test Conditions for Improved Evaluation of Ecological Hazards of Engineered Nanomaterials. Environmental Science & Technology 2016, 50, 6124 -6145.

AMA Style

Patricia A. Holden, Jorge L. Gardea-Torresdey, Fred Klaessig, Ronald F. Turco, Monika Mortimer, Kerstin Hund-Rinke, Elaine A. Cohen Hubal, David Avery, Damià Barceló, Renata Behra, Yoram Cohen, Laurence Deydier-Stephan, Patrick Lee Ferguson, Teresa F. Fernandes, Barbara Herr Harthorn, William Matthew Henderson, Robert A. Hoke, Danail Hristozov, John M. Johnston, Agnes B. Kane, Larry Kapustka, Arturo A. Keller, Hunter S. Lenihan, Wess Lovell, Catherine J. Murphy, Roger M. Nisbet, Elijah J. Petersen, Edward R. Salinas, Martin Scheringer, Monita Sharma, David E. Speed, Yasir Sultan, Paul Westerhoff, Jason C. White, Mark R. Wiesner, Eva M. Wong, Baoshan Xing, Meghan Steele Horan, Hilary A. Godwin, André E. Nel. Considerations of Environmentally Relevant Test Conditions for Improved Evaluation of Ecological Hazards of Engineered Nanomaterials. Environmental Science & Technology. 2016; 50 (12):6124-6145.

Chicago/Turabian Style

Patricia A. Holden; Jorge L. Gardea-Torresdey; Fred Klaessig; Ronald F. Turco; Monika Mortimer; Kerstin Hund-Rinke; Elaine A. Cohen Hubal; David Avery; Damià Barceló; Renata Behra; Yoram Cohen; Laurence Deydier-Stephan; Patrick Lee Ferguson; Teresa F. Fernandes; Barbara Herr Harthorn; William Matthew Henderson; Robert A. Hoke; Danail Hristozov; John M. Johnston; Agnes B. Kane; Larry Kapustka; Arturo A. Keller; Hunter S. Lenihan; Wess Lovell; Catherine J. Murphy; Roger M. Nisbet; Elijah J. Petersen; Edward R. Salinas; Martin Scheringer; Monita Sharma; David E. Speed; Yasir Sultan; Paul Westerhoff; Jason C. White; Mark R. Wiesner; Eva M. Wong; Baoshan Xing; Meghan Steele Horan; Hilary A. Godwin; André E. Nel. 2016. "Considerations of Environmentally Relevant Test Conditions for Improved Evaluation of Ecological Hazards of Engineered Nanomaterials." Environmental Science & Technology 50, no. 12: 6124-6145.

Research article
Published: 02 May 2016 in Nanotoxicology
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Increased use of nanomaterials has raised concerns about the potential for undesirable human health and environmental effects. Releases into the air may occur and therefore, the inhalation route is of specific interest. Here we tested copper oxide nanoparticles (CuO NPs) after repeated inhalation as hazard data for this material and exposure route is currently lacking for risk assessment. Rats were exposed nose-only to a single exposure concentration and by varying the exposure time, different dose levels were obtained (C x T protocol). The dose is expressed as 6 hour-concentration equivalents of 0, 0.6, 2.4, 3.3, 6.3 and 13.2 mg/m3 CuO NPs, with a primary particle size of 10 9.2-14 nm and an MMAD of 1.5 µm. Twenty four hours after a 5-day exposure, dose-dependent lung inflammation and cytotoxicity was observed. Histopathological examinations indicated alveolitis, bronchiolitis, vacuolation of the respiratory epithelium and emphysema in the lung starting at 2.4 mg/m3. After a recovery period of 22 days, limited inflammation was still observed, but only at the highest dose of 13.2 mg/m3. The olfactory epithelium in the nose degenerated twenty four hours after exposure to 6.3 and 13.2 mg/m3, but this was restored after 22 days. No histopathological changes were detected in the brain, olfactory bulb, spleen, kidney and liver. In conclusion, a 5-day, 6-hour/day exposure equivalent to an aerosol of agglomerated CuO NPs resulted in a dose-dependent toxicity in rats, which almost completely resolved during a 3-week post-exposure period.

ACS Style

Ilse Gosens; Flemming R. Cassee; Michela Zanella; Laura Manodori; Andrea Brunelli; Anna Luisa Costa; Bas G. H. Bokkers; Wim H. De Jong; David Brown; Danail Hristozov; Vicki Stone. Organ burden and pulmonary toxicity of nano-sized copper (II) oxide particles after short-term inhalation exposure. Nanotoxicology 2016, 10, 1084 -1095.

AMA Style

Ilse Gosens, Flemming R. Cassee, Michela Zanella, Laura Manodori, Andrea Brunelli, Anna Luisa Costa, Bas G. H. Bokkers, Wim H. De Jong, David Brown, Danail Hristozov, Vicki Stone. Organ burden and pulmonary toxicity of nano-sized copper (II) oxide particles after short-term inhalation exposure. Nanotoxicology. 2016; 10 (8):1084-1095.

Chicago/Turabian Style

Ilse Gosens; Flemming R. Cassee; Michela Zanella; Laura Manodori; Andrea Brunelli; Anna Luisa Costa; Bas G. H. Bokkers; Wim H. De Jong; David Brown; Danail Hristozov; Vicki Stone. 2016. "Organ burden and pulmonary toxicity of nano-sized copper (II) oxide particles after short-term inhalation exposure." Nanotoxicology 10, no. 8: 1084-1095.