A unified framework for nanosafety is needed

Scott-Fordsmand, Janeck J.; Pozzi-Mucelli, Stefano; Tran, Lang; Aschberger, Karin; Sabella, Stefania; Vogel, Ulla; Poland, Craig A.; Balharry, Dominique; Fernandes, Teresa F.; Gottardo, Stefania; Hankin, Steve; Hartl, Mark G. J.; Hartmann, Nanna B.; Hristozov, Danail; Hund‐Rinke, Kerstin; Johnston, Helinor Jane; Marcomini, A.; Panzer, O.; Roncato, Davide; Saber, Anne Thoustrup; Wallin, Håkan; Stone, Vicki

doi:10.1016/j.nantod.2014.07.001

Cited by 30 publications

(20 citation statements)

References 0 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…In this framework, the properties of GRMs may be significantly affected during their passage through the GI tract, due to interaction with the different biological environments (typically composed of complex mixtures of organic and inorganic molecules active in harsh/mild pH conditions), becoming, after the biotransformation, novel species with different characteristics and unknown biological impact. In this respect, some information is available on biotransformation of carbon nanomaterials, including GO and oxidized carbon nanotubes (CNTs), showing that they may be degraded both in vitro and in vivo by oxidase enzymes, such as horseradish peroxidase (HRP) and human myeloperoxidase (hMPO) that are usually present in physiological fluids . Notably, detailed knowledge about biotransformation is crucial to address recent regulatory requirements for nanomaterials that suggest a direct relationship between biological transformation/persistence/degradation and/or release of toxic compounds and hazard …”

Section: Introductionmentioning

confidence: 99%

Biotransformation and Biological Interaction of Graphene and Graphene Oxide during Simulated Oral Ingestion

Guarnieri

Sánchez-Moreno

Castillo

et al. 2018

Small

View full text Add to dashboard Cite

The biotransformation and biological impact of few layer graphene (FLG) and graphene oxide (GO) are studied, following ingestion as exposure route. An in vitro digestion assay based on a standardized operating procedure (SOP) is exploited. The assay simulates the human ingestion of nanomaterials during their dynamic passage through the different environments of the gastrointestinal tract (salivary, gastric, intestinal). Physical-chemical changes of FLG and GO during digestion are assessed by Raman spectroscopy. Moreover, the effect of chronic exposure to digested nanomaterials on integrity and functionality of an in vitro model of intestinal barrier is also determined according to a second SOP. These results show a modulation of the aggregation state of FLG and GO nanoflakes after experiencing the complex environments of the different digestive compartments. In particular, chemical doping effects are observed due to FLG and GO interaction with digestive juice components. No structural changes/degradation of the nanomaterials are detected, suggesting that they are biopersistent when administered by oral route. Chronic exposure to digested graphene does not affect intestinal barrier integrity and is not associated with inflammation and cytotoxicity, though possible long-term adverse effects cannot be ruled out.

show abstract

Section: Introductionmentioning

confidence: 99%

Biotransformation and Biological Interaction of Graphene and Graphene Oxide during Simulated Oral Ingestion

Guarnieri

Sánchez-Moreno

Castillo

et al. 2018

Small

View full text Add to dashboard Cite

show abstract

“…A number of studies have been developing risk banding tools (e.g., Stoffenmanager Nano, NanoRiskCat, Swiss Precautionary Matrix, NanoSafer etc. ), which are based on the precautionary principle and are designed to incorporate the full range of uncertainty in their results in order to inform risk management decisions based on worst‐case scenarios . In a differing approach, the U.S. FDA, among other agencies, convenes quarterly interest groups that review risk and regulatory concerns of emerging trends in NM development, including risk categorization exercises and product‐specific regulatory discussion .…”

Section: A Framework For Nm Risk Governancementioning

confidence: 99%

“…), which are based on the precautionary principle and are designed to incorporate the full range of uncertainty in their results in order to inform risk management decisions based on worst-case scenarios. (40) In a differing approach, the U.S. FDA, among other agencies, convenes quarterly interest groups that review risk and regulatory concerns of emerging trends in NM development, including risk categorization exercises and product-specific regulatory discussion. (21,22) Moreover, risk screening and ranking schemes based on weight-of-evidence approaches have been proposed that explicitly estimated the uncertainty stemming from hazard and exposure assessments.…”

Section: Tools and Strategies For Assessing Potential Risk And Risk Dmentioning

confidence: 99%

The Essential Elements of a Risk Governance Framework for Current and Future Nanotechnologies

et al. 2017

Self Cite

View full text Add to dashboard Cite

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.

show abstract

“…The number of characterisers required by the authority should be kept to the lowest, yet sufficient number possible to confer the ability to induce hazardous particle-cell interactions. The use of a defined set of characterisers for a nanospecific safety assessment has been put forward by other authors (Scott-Fordsmand et al, 2014;Arts et al, 2014Arts et al, , 2015Lynch et al, 2014). What is missing however is a sound differentiation system for nanomaterials, which can accommodate nanoforms of multiple elements.…”

Section: Introductionmentioning

confidence: 99%

Sameness: The regulatory crux with nanomaterial identity and grouping schemes for hazard assessment

Walser

Studer

2015

Regulatory Toxicology and Pharmacology

View full text Add to dashboard Cite

A unified framework for nanosafety is needed

Cited by 30 publications

References 0 publications

Biotransformation and Biological Interaction of Graphene and Graphene Oxide during Simulated Oral Ingestion

Biotransformation and Biological Interaction of Graphene and Graphene Oxide during Simulated Oral Ingestion

The Essential Elements of a Risk Governance Framework for Current and Future Nanotechnologies

Sameness: The regulatory crux with nanomaterial identity and grouping schemes for hazard assessment

Contact Info

Product

Resources

About