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

Walser, Tobias; Studer, Christoph

doi:10.1016/j.yrtph.2015.05.031

Cited by 21 publications

(15 citation statements)

References 12 publications

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“…The numerous potential combinations of size, shape, surface coating and chemical cores of ENMs also present a logistical challenge regarding the volume of work to test each material, or group of ENMs as a new substance (e.g., ref. [36][37][38][39][40]. Consequently, we advocate a tiered approach to the testing strategy ( Fig.…”

Section: A Tiered Approach To Dietary Bioaccumulation Testingmentioning

confidence: 99%

Proposal for a tiered dietary bioaccumulation testing strategy for engineered nanomaterials using fish

Handy

Ahtiainen²,

Navas

et al. 2018

Environ. Sci.: Nano

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Section: A Tiered Approach To Dietary Bioaccumulation Testingmentioning

confidence: 99%

Proposal for a tiered dietary bioaccumulation testing strategy for engineered nanomaterials using fish

Handy

Ahtiainen²,

Navas

et al. 2018

Environ. Sci.: Nano

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“…This has become a dynamic area of research and several frameworks for grouping and read-across of MNs have been proposed (Arts et al, 2015a, RIVM, 2015, ECHA, JRC and RIVM, 2016, Gebel et al, 2014, Walser and Studer, 2015. These approaches are still rather conceptual and are not based on sufficient understanding of the interdependencies among the intrinsic and extrinsic properties of MNs and their observed adverse biological effects .…”

Section: Framework For Ra Of Mnsmentioning

confidence: 99%

Frameworks and tools for risk assessment of manufactured nanomaterials

Hristozov

Gottardo

Semenzin

et al. 2016

Environment International

101

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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 screeninglevel 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.

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“…This has already been recognized early on and several grouping frameworks have been proposed [108–113]. The concept of Walser et al [111] proposes as the first step to group the unlimited nanomaterials identified into a limited number of entities. The chemical composition of each structural element (core, coating, etc.…”

Section: Green Toxicology For Nanomaterials: Read-across and Groupingmentioning

confidence: 99%

“…These biunique entities may include many similar nanomaterial identities, which are considered the same from a regulatory perspective. In a second step, entities are allocated to groups (clouds), which represents specific testing strategies for toxicological endpoints that need further evaluation [111]. This allocation is driven by AOPs [27], in which key events are triggered in a cascade-like manner, ultimately leading to an undesirable biological response [114, 115].…”

Section: Green Toxicology For Nanomaterials: Read-across and Groupingmentioning

confidence: 99%

Green Toxicology: a strategy for sustainable chemical and material development

et al. 2017

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Green Toxicology refers to the application of predictive toxicology in the sustainable development and production of new less harmful materials and chemicals, subsequently reducing waste and exposure. Built upon the foundation of “Green Chemistry” and “Green Engineering”, “Green Toxicology” aims to shape future manufacturing processes and safe synthesis of chemicals in terms of environmental and human health impacts. Being an integral part of Green Chemistry, the principles of Green Toxicology amplify the role of health-related aspects for the benefit of consumers and the environment, in addition to being economical for manufacturing companies. Due to the costly development and preparation of new materials and chemicals for market entry, it is no longer practical to ignore the safety and environmental status of new products during product development stages. However, this is only possible if toxicologists and chemists work together early on in the development of materials and chemicals to utilize safe design strategies and innovative in vitro and in silico tools. This paper discusses some of the most relevant aspects, advances and limitations of the emergence of Green Toxicology from the perspective of different industry and research groups. The integration of new testing methods and strategies in product development, testing and regulation stages are presented with examples of the application of in silico, omics and in vitro methods. Other tools for Green Toxicology, including the reduction of animal testing, alternative test methods, and read-across approaches are also discussed.

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

Cited by 21 publications

References 12 publications

Proposal for a tiered dietary bioaccumulation testing strategy for engineered nanomaterials using fish

Proposal for a tiered dietary bioaccumulation testing strategy for engineered nanomaterials using fish

Frameworks and tools for risk assessment of manufactured nanomaterials

Green Toxicology: a strategy for sustainable chemical and material development

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