Genotoxicity testing for nanomaterials remains challenging as standard testing approaches require some adaptation, and further development of nano-specific OECD Test Guidelines (TGs) and Guidance Documents (GDs) are needed. However, the field of genotoxicology continues to progress and new approach methodologies (NAMs) are being developed that could provide relevant information on the range of mechanisms of genotoxic action that may be imparted by nanomaterials. There is a recognition of the need for implementation of new and/or adapted OECD TGs, new OECD GDs, and utilization of NAMs within a genotoxicity testing framework for nanomaterials. As such, the requirements to apply new experimental approaches and data for genotoxicity assessment of nanomaterials in a regulatory context is neither clear, nor used in practice. Thus, an international workshop with representatives from regulatory agencies, industry, government, and academic scientists was convened to discuss these issues. The expert discussion highlighted the current deficiencies that exist in standard testing approaches within exposure regimes, insufficient physicochemical characterization, lack of demonstration of cell or tissue uptake and internalization, and limitations in the coverage of genotoxic modes of action. Regarding the latter aspect, a consensus was reached on the importance of using NAMs to support the genotoxicity assessment of nanomaterials. Also highlighted was the need for close engagement between scientists and regulators to (i) provide clarity on the regulatory needs, (ii) improve the acceptance and use of NAM-generated data, and (iii) define how NAMs may be used as part of weight of evidence approaches for use in regulatory risk assessments.

The OECD test guidelines for animal experiments play an important role in evaluating the chemical hazards. Animal tests performed using OECD guidelines, especially when the good laboratory practice (GLP) principle is applied, reduce the duplication of toxicity testing and ensure the best mutual acceptance of data by the OECD\'s Mutual Acceptance of Data (MAD). The OECD inhalation toxicity test guidelines 412 (28 days) and 413 (90 days) have been revised. These OECD guidelines now reflect the inclusion of nanomaterials and recent scientific and technological developments. In particular, these test guidelines aim to evaluate the bronchoalveolar lavage fluid in the lungs for objective toxicity evaluation, along with the existing subjective histopathological evaluation. For solid particles, the lung burden measurement of particles is required for toxicokinetic studies and, in order to properly perform a toxicokinetic study, two post-exposure observations are recommended. In light of the revised OECD guidelines, we propose a method to reduce the number of animals when testing is conducted for nanomaterials.

A shared feature in the value proposition of every nanomaterial-based drug delivery systems is the desirable improvement in the disposition (or ADME) and pharmacokinetic profiles of the encapsulated drug being delivered. Remarkable progress has been made towards understanding the complex and multifactorial relationships between pharmacokinetic profiles and nanomaterial physicochemical properties, biological interactions, species physiology, etc. These advances have fuelled the rational design of numerous nanomaterials with long-circulation times and improved tissue accumulation (e.g., in tumours). Unfortunately, a central weakness in many of these research efforts has been the inconsistent and insufficient characterisation of the pharmacokinetic profiles of nanomaterials in scientific reporting-a problem affecting the majoirty of of contemporary nanomaterials literature and innovative nanomaterials in early stages of preclinical development especially. Given the significant role of pharmacokinetic assessments to serve as guideposts for deciding whether to continue with the preclinical development and clinical translation of drug delivery systems, the prevalence of poor pharmacokinetic characterisations in nanomaterials research is particularly alarming. A conspicuous problem in many reports is the inappropriate selection of experimental designs and methodologies for studying nanomaterial pharmacokinetics, the consequences of which are increased uncertainty over the accurate interpretation of reported pharmacokinetic data and diminished experimental reproducibility throughout the field. Thus, there is renewed interest in the establishment of consistent and comprehensive strategies for designing preclinical experiments to assess the pharmacokinetics of nanomaterials with diverse physicochemical properties. Towards this end, herein are proposed simple guidelines for the experimental design of pharmacokinetic studies with nanomaterials drawn from the best research practices, principle strategies, and important considerations used in industry for collecting pharmacokinetic data in preclinical animal models. Specifically, key experimental design factors in these studies are identified and examined in the context of nanomaterials for optimality, including blood sampling strategy and technique, sample allocation and sampling time window, test species selection, experimental sources of pharmacokinetic variability, etc. Methods for noninvasive imaging-derived pharmacokinetic assessments of theranostic nanomaterials are also explored with particular focus on emission tomography imaging modalities. Taken together, this review will provide nanomaterial researchers with practical knowledge and pragmatic recommendations for selecting the best designs and methodologies for assessing the pharmacokinetic profiles of their nanomaterials, and hopefully maximise the chances of translational success of these innovative products into humans.

OBJECTIVE: To provide a guideline for assessing the occupational exposure to nanomaterials in workplaces in China.
METHODS: Based on the basic requirement for the sampling of harmful substances, condensation particle counter/optical particle counter (CPC/OPC) was selected as the tool and the total number concentration (TNC) was used as an index to measure engineering nanomaterials in workplaces.
RESULTS: The strategy included instrument preparation, identification of particle-emission source, particle-property analysis, measurement of background concentration, concentration measurement based on working activity, concentration calculation and analysis, and recording of measurements.
CONCLUSIONS: The draft guideline based on traditional industrial hygiene practices can be used to identify the emission source of nanomaterials, qualitatively and quantitatively assess exposure to nanomaterials in workplaces.

The unique physical and chemical properties of graphene-based nanomaterials (GNMs) have inspired a diverse range of scientific and industrial applications. The market value of GNMs is predicted to reach $US 1.3 billion by 2023. Common to many nanomaterials, an important and unresolved question is the environmental consequences of the increases in GNMs use. The current deficiencies in studies reporting ecotoxicology data for GNMs include differences in analytical methodologies for quantification, no standardized test guidelines, differences in morphology of GNMs, the lack of Chemical Abstract Service numbers, and the quality of the reported data. The assessment of potential adverse effects on aquatic organisms typically relies on guideline values based on species sensitivity distributions (SSDs) of toxicity data. We present preliminary water quality guideline values for graphene oxide NMs in freshwaters. Data include 10 species from 7 phyla (bacteria and fungi were not included). The most sensitive organism was found to be the freshwater shrimp Palaemon pandaliformis. The derived guideline values for 99, 95, 90, and 80% species protection were 350, 600, 830, and 1300 μg/L, respectively. These results will contribute to the regulatory derivations of future water quality guideline values for graphene-based NMs. Environ Toxicol Chem 2018;37:1340-1348. © 2018 SETAC.