A methodology on how to create a real-life relevant risk profile for a given nanomaterial

Abstract

Please cite this article in press as: Schimpel, C. et al1., A methodology on how to create a real-life relevant risk profile for a given nanomaterial. J. Chem. Health Safety (2017), http://dx.doi.org/10.1016/j.jchas.2017.06.002 RESEARCH ARTICLEA methodology on how to create a real-life relevant risk profile for a given nanomaterial With large amounts of nanotoxicology studies delivering contradicting results and a complex, moving regulatory framework, potential risks surrounding nanotechnology appear complex and confusing. Many researchers and workers in different sectors are dealing with nanomaterials on a day-to-day basis, and have a requirement to define their assessment/management needs. This paper describes an industry-tailored strategy for risk assessment of nanomaterials and nano-enabled products, which builds on recent research outcomes. The approach focuses on the creation of a risk profile for a given nanomaterial (e.g., determine which materials and/or process operation pose greater risk, where these risks occur in the lifecycle, and the impact of these risks on society), using state-of-the-art safety assessment approaches/tools (ECETOC TRA, Stoffenmanager Nano and ISO/TS 12901-2:2014). The developed nanosafety strategy takes into account cross-sectoral industrial needs and includes (i) Information Gathering: Identification of nanomaterials and hazards by a demand-driven questionnaire and on-site company visits in the context of human and ecosystem exposures, considering all companies/parties/downstream users involved along the value chain; (ii) Hazard Assessment: Collection of all relevant and available information on the intrinsic properties of the substance (e.g., peer reviewed (eco)toxicological data, material safety data sheets), as well as identification of actual recommendations and benchmark limits for the different nano-objects in the scope of this projects; (iii) Exposure Assessment: Definition of industry-specific and application-specific exposure scenarios taking into account operational conditions and risk management measures; (iv) Risk Characterisation: Classification of the risk potential by making use of exposure estimation models (i.e., comparing estimated exposure levels with threshold levels); (v) Refined Risk Characterisation and Exposure Monitoring: Selection of individual exposure scenarios for exposure monitoring following the OECD Harmonized Tiered Approach to refine risk assessment; (vi) Risk Mitigation Strategies: Development of risk mitigation actions focusing on risk prevention.

Health and Safety Concerns Related to CNT and Graphene Products, and Related Composites

“…Risk estimation and characterization is defined by REACH [66] and comparing exposure and hazard levels provides the estimate of a Risk Characterization Ratio, defining process categories versus environmental risk categories. It also presents an overview of selected risk assessment tools [68].…”

“…Healthy and safety from cradle to grave will ensure safe innovations in nanomaterials and products. Nanosafety strategies must start by information gathering to achieve risk mitigation, followed by hazard and exposure assessment, risk characterization and monitoring [68]. There is no consensus regarding safe occupational exposure limits for specific CNTs.…”

Critical Considerations on the Clinical Translation of Upconversion Nanoparticles (UCNPs): Recommendations from the European Upconversion Network (COST Action CM1403)

“…The European REACH (registration, evaluation, authorization, and restriction of chemicals) legislation defines the estimation and characterization of risks as the ratio of exposure levels to hazard levels (risk characterization ratio, RCR) (https://echa.europa.eu/regulations/reach/legislation). A quantitative risk assessment of NMs, however, is not feasible because standardized, validated and specific methods providing quantitative data and limits on human (worker, consumer, patients) or environmental exposure have not been specified, yet . A large number of potential nanoenabled products fail because the lack of physicochemical characterization leads to contradictory results on the efficacy, biocompatibility, product sterility, and safety…”

“…Since conventional methods can only provide an initial EQS assessment of UCNPs, customized protocols, and validated analytical techniques are required that comply with the demands of metrology. Controls and reference materials must be in line with biomedical applications and commercial applications in order to bridge the translational gap of UCNPs . The general need for a standardized assessment of NMs has been recognized all over the world .…”

Potential ecotoxicological effects of antimicrobial surface coatings: a literature survey backed up by analysis of market reports

“…In addition, SbD approach will help AMCs industry to align easier with the European REACH regulation (European Commission, 2006) that requires hazard assessment, exposure assessment and risk characterization of chemicals as integral parts of the chemical safety assessment process (ECHA, 2010). The hazard assessment analyzes all available and relevant data on adverse effects to both human and environmental health, including physicochemical properties, (eco)toxicological outcomes and threshold limits for occupational and environmental effects (Schimpel et al, 2018). Exposure assessment describes and identifies exposure scenarios along life-cycle of chemicals.…”