Table 1 Existing standards and guidelines

Organization for Economic Cooperation and Development (OECD) Working party on Manufactured Nanomaterials (WPNM)

OECD WPNM working on the development of methods and strategies to identify and manage the potential health and environmental risks of nanomaterials. Review the current OECD test guidelines for applicability to ENMs. Identify the need to develop new test guidelines

Testing Program of Manufactured ENMs Dossier on Titanium Dioxide—PART 1/1; 1/2; 1/3 [80]

Document presents the Dossier of the Titanium Dioxide (TiO2) manufactured ENMs

OECD GD 211 [81]

Guidance Document for Describing Non-Guideline In Vitro Test Methods

International Organization for Standardization (ISO) Technical Committee (TC) 229

Special issues on nanotechnologies

ISO/TC 229 (free available preview):

This Technical Report provides guidance for the physicochemical characterization of manufactured nano-objects and their aggregates and agglomerates (NOAA) greater than 100 nm presented for toxicological testing to aid in assessing and interpreting the toxicological impact of manufactured nano-objects and to allow the material under test to be differentiated from seemingly similar materials

ISO/TR 13,014:2012(en) Nanotechnologies — Guidance on physico-chemical characterization of engineered nanoscale materials for toxicologic assessment [47]

EU’s regulation committee: Registration, Evaluation, Authorization and Restriction of Chemicals (REACH)

Registration of substances that are manufactured or imported at a rate higher than one ton per year. These substances include ENMs with a focus on industrial scale production

REACH regulation on nanoforms [48]

Lists a range of physicochemical parameters necessary for the registration of ENMs. Including intrinsic and system-dependent material properties

Minimum Information Reporting in Bio–Nano Experimental Literature (MIRIBEL)

MIRIBEL describes the minimum information, including a reporting checklist which should contribute strongly to reproducibility, quantitative research, and communication of scientific results

Scientific publication [25]

Lists three categories to be reported: materials characterization, biological characterization, and details of experimental protocols

DaNa

DaNa project developed a methodology for selecting, recording, and evaluating existing toxicological publications

DaNa Checklist [82]

A checklist provides a collection of criteria which should be included: physicochemical characteristics of ENM, sample preparation, test-parameter and general information on data analysis and statistics (checklist)

In vitro approaches to assess the hazard of ENMs

Review article: Broadly discuss the current state-of the art ENM hazard assessment strategies using in vitro approaches

Scientific publication [3]

The main topics are the preparation and physicochemical characterization of ENM, choice and characterization of the cellular models, simulation of a realistic exposure and dosimetry, use of controls, and the cellular response readout. This information provides important recommendations for the planning, implementation, and analysis of nanosafety studies

National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs)

Replacement, Refinement and Reduction of Animals in Research

Animal Research: Reporting of In Vivo Experiments (ARRIVE); The ARRIVE guidelines 2.0: author checklist [34]

Checklist of recommendations to improve the reporting of research involving animals – maximising the quality and reliability of published research, and enabling others to better scrutinise, evaluate and reproduce it

Library of Integrated Network-Based Cellular Signatures (LINCS)

Supplies description standards with a focus on reagents, assays, and experiments

Metadata Specifications: Cell Lines [83]

Metadata specifications for assays and experiments

Template for the description of cell-based toxicological test methods to allow evaluation and regulatory use of the data

Detailed toxicity test method template (ToxTemp)

Scientific publication [84]

Template for the Description of Cell-Based Toxicological Test Methods to Allow Evaluation and Regulatory Use of the Data

Minimum Information about a Flow Cytometry Experiment (MIFlowCyt)

Supports storage, annotation, analysis, and sharing of flow cytometry datasets

Scientific publication [58]

Minimum Information about flow cytometry experiments

Reproducibility in light microscopy: Maintenance, standards and SOPs

Recommendations for quantitative microscopy data and reproducible results

Scientific publication [56]

Method specific guidance on the use of light microscopy

4D Nucleome Initiative (4DN) Imaging Standards Working Group (IWG)

Working in conjunction with the BioImaging North America (BINA) Quality Control and Data Management Working Group (QC-DMWG), propose light Microscopy Metadata specifications that scale with experimental intent and with the complexity of the instrumentation and analytical requirements

Scientific publication [57]

Minimum information for fluorescence microscopy—The proposal is an extension of the OME data model and aims at increasing data fidelity, ease future analysis, and facilitate objective comparison of different datasets, experimental setups, and essays