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 Fact Sheets

These documents address specific key points on a selection of the main topics.

Reference name: caLIBRAte Factsheets
Description: This Technical Fact Sheet introduces the Cooper Stage-gate product innovation model and stakeholder priorities for its translation into risk assessment models.
Document(s): Download CALIBRATEFACSHEET_1_CRITERIA FOR HUMAN EXPOSURE, HAZARD, RISK ASSESSMENT MODELS.PDF (04.10.2019)
URL(s): Criteria for human exposure, hazard, risk assessment models (04.10.2019)
Reference name: caLIBRAte Factsheets
Description: Stakeholders from business, government, research, insurance and other organisations were approached through a two-round Delphi survey and an international workshop. The work -shop was established to explore specific requirements and topics identified. Participating stakeholders were identified as competent in and/or involved in the field of nano-technology and nano-innovation and covered at least 15 declared countries.
Document(s): Download CALIBRATEFACSHEET_2_STAKEHOLDER NEEDS AND PERSPECTIVES FOR DEVELOPMENT OF A NRGF.PDF (04.10.2019)
URL(s): Stakeholder needs and perspectives for development of a NRGF (04.10.2019)
Reference name: caLIBRAte Factsheets
Description: A multinational, mixed method approach was used to consult different stakeholder groups from industry, insurance, research and policy-oriented and civil society organisations, and as well citizens on risk awareness and perception on nanomaterials and nano-related products. The six top risks domains emerged by the consultation cover public, worker and animal health, environmental, economic and ethical and social aspects.
Document(s): Download CALIBRATEFACSHEET_3_PERCEIVED RISKS OF NANOMATERIALS AND NANO-RELATED PRODUCTS.PDF (04.10.2019)
URL(s): Perceived risks of nanomaterials and nano-related products (04.10.2019)
Reference name: caLIBRAte Factsheets
Description: Horizon scanning (HS) technique can aid in identifying information and data sources that are likely to have the greatest future impact. It collates data (usually web-based) and use text analytics to evaluate and rank topics relevant to a given issue. Different analytics are performed on collected data in order to visualize the huge amount of data and to draw the useful conclusions from it. Thus, it enables stakeholders to discuss early on, what the intended and unintended effects of the identified developments might be. The outputs from HS are being increasingly used to support policy-making and interventions by governments and private entities over a wide range of risk related issues.
Document(s): Download CALIBRATEFACSHEET_4_COMPREHENSIVE ANALYSIS OF AVAILABLE TOOLS AND METHODS FOR HS.PDF (04.10.2019)
URL(s): Comprehensive analysis of available tools and methodologies for Horizon Scanning (04.10.2019)
Reference name: caLIBRAte Factsheets
Description: caLIBRAte has focused on the identification and categorization of suitable existing Human Risk Assessment (HRA) models along the stages in a Cooper Stage-Gate® Idea to Market model as defined by stakeholders (SHs). Within the project, this knowledge will create the basis of a gap analysis to further refine the existing HRA models.
Document(s): Download CALIBRATEFACSHEET_5_CURRENT HAZARD EXPOSURE AND HRA MODELS CONSIDERED COOPER SG.PDF (04.10.2019)
URL(s): Current hazard, exposure and (integrated) HRA models considered for input requirements and applicability at the Cooper innovation stage-gates defined (04.10.2019)
Reference name: caLIBRAte Factsheets
Description: Diverse HRA tools are openly or commercially available for evaluating safety aspects of MNMs, yet it is clear that their application to that purpose often couples with notable degrees of uncertainty. Current risk assessment practice for new industrial agents, such as manufactured nanomaterials (MNMs), including consideration of both exposure and hazard assessment, can be substantially aided by so-called “New approach methodologies” (NAMs).
Document(s): Download CALIBRATEFACSHEET_7_PRIORITIZATION OF INNOVATIVE HAZARD EXPOSURE AND RISK ASSESSMENT MODELS TOWARDS STAGE-GATE APPLICATION.PDF (04.10.2019)
URL(s): Prioritization of innovative hazard exposure and risk assessment models towards stage-gate application (04.10.2019)
Reference name: caLIBRAte Factsheets
Description: The project used the Stage-Gate concept as an approach to gauge the suitability of different models for the ecological risk assessment at different stages of nanoenabled development. Within the innovation chain, the level of information needed for, and required from, environmental assessment models increases at each stage. In early stages, with little information available, risk evaluation tools that can operate with limited data may best fit need. At later stages, where more complex and extensive data and outputs are relevant, models providing greater detail may be better suited.
Document(s): Download CALIBRATEFACSHEET_8_SELECTING ENVIRONMENTAL HAZARD, EXPOSURE AND RISK ASSESSMENT MODELS AT DIFFERENT STAGE-GATES.PDF (04.10.2019)
URL(s): Selecting environmental hazard, exposure and risk assessment models at different stage-gates (04.10.2019)
Reference name: caLIBRAte Factsheets
Description: To support efficient environmental risk assessment of nanomaterials, a suite of modelling tools is needed including hazard, exposure and risk assessment tools. caLIBRAte aimed at improving suitable existing environmental models selected in the project. Some of the models were further developed and new functionalities were added. For other models the work performed in caLIBRAte centered primarily on improving the input to the models rather than making changes to the core models.
Document(s): Download CALIBRATEFACSHEET_9_IMPROVING SUITABLE EXISTING ENVIRONMENTAL HAZARD, EXPOSURE AND RISK ASSESSMENT MODELS.PDF (04.10.2019)
URL(s): Improving suitable existing environmental hazard, exposure and risk assessment models (04.10.2019)
Reference name: caLIBRAte Factsheets
Description: The use of innovative methods, such as ‘omics' technologies (e.g. transcriptomics) are gaining importance in the field of nano-ecotoxicology; an increasing number of studies are aiming to investigate the effects of engineered nanomaterials (ENMs) in this way. However, systematic synthesis of the outcome of such studies regarding common responses and toxicity pathways is currently lacking. The caLIBRAte project performed a meta-analysis for environmentally relevant transcriptomic studies of engineered nanomaterials (ENMs) in order to study the molecular mechanisms in an unbiased way.
Document(s): Download CALIBRATEFACSHEET_10_DO ENVIRONMENTAL MODEL ORGANISMS EXPOSED TO NANOPARTICLES EXHIBIT A COMMON TOXICOLOGICAL RESPONSE.PDF (04.10.2019)
Reference name: caLIBRAte Factsheets
Description: Risk communication is a cross-cutting aspect of the risk governance frameworks alongside participation, and the well known practices of risk evaluation, mitigation, assessment and management. The design of effective risk governance tools and guidance requires the development of tools with risk communication as an inherent characteristic. In this view, an analysis and review of risk governance methods and procedures has been performed against a set of criteria. The set of criteria for risk evaluation, mitigation and communication (tolerability and acceptability of the risk) has been identified, based on the analysis of scientific literature and the outcomes of the caLIBRAte research project, following a two step process that included a dedicated stakeholder workshop and literature review, resulting in a list of 37 criteria. A similar literature review has been performed for the identification of risk governance tools, through combined search queries, which resulted in a list of 60 relevant tools.
Document(s): Download CALIBRATEFACSHEET_11_CRITERIA AND PROCEDURES FOR RISK EVALUATION, MITIGATION AND COMMUNICATION.PDF (04.10.2019)
URL(s): Criteria and procedures for risk evaluation, mitigation and communication (04.10.2019)
Reference name: caLIBRAte Factsheets
Description: For the performance testing of the risk assessment tools and models selected for the caLIBRAte Nano Risk Governance Portal, data on physico-chemical characteristics, toxicity, exposure and environmental fate of a range of nanomaterials are needed. This factsheet describes how the required data were identified and gathered. First of all, the inand output parameters of the selected tools were collected, as for these parameters values need to be retrieved from the existing databases. Subsequently, data requirements considering the quality and completeness of the data have been listed.
Document(s): Download CALIBRATEFACSHEET_12_IDENTIFICATION AND COLLATION OF DATA REQUIRED FOR PERFORMANCE TESTING.PDF (04.10.2019)
URL(s): Identification and collation of data required for performance testing (04.10.2019)
Reference name: caLIBRAte Factsheets
Description: Assessing data quality within the nanosafety field is challenged by its multidisciplinary nature, where highly diverse fields of research have traditionally handled, stored and annotated their data in widely different ways. Topics such as uncertainty, reproducibility and interoperability are now being tackled within the nano-community to address viable solutions for complex data quality assessment. The proposed caLIBRAte quality assessment method involves the scoring of relevance, reliability and completeness of data, including the possibility of addressing the entities in a flexible order and related to a developing and increasingly precise nanomaterials ontology
Document(s): Download CALIBRATEFACSHEET_13_QUALITY CRITERIA FOR DATA WITHIN NANOMATERIALS ASSESSMENT.PDF (05.10.2019)
URL(s): Quality criteria for data within nanomaterials assessment (05.10.2019)
Reference name: caLIBRAte Factsheets
Description: For performance testing of models and tools for human and environmental risk assessment of nanomaterials selected in the caLIBRAte project, appropriate data sets are needed. Several European and national projects have produced an enormous amount of data on hazard, release and exposure of nanomaterials, including EU-projects NANoREG, NANOSOLUTIONS, MARINA and NANOGENOTOX, that may be of significant use for assessment. A thorough analysis, comparing the available information on 34 reference nanomaterials with the input parameters required by the models, was completed within caLIBRAte. Complete datasets were identified, as were data gaps. The latter were identified with the goal to generate new data within the project to fill these gaps. A detailed gap analysis on information for physico-chemical characteristics, human toxicity and ecotoxicity for different nanoforms of specific reference nanomaterials was carried out using the data from the caLIBRAte database (data from projects MARINA, NANoREG, NANOGENOTOX, NanoTest) plus additional data from projects EnvNano, nanoFATE, NanoMILE and the NanoETox dataset, plus data available from OECD. The information on nanomaterials from within those data sets was matched to the identified input parameters of the selected models for human and environmental risk assessments along the different stages of the Cooper StageGate model: Guidenano, NanoSafer, LICARA, SUNDS, Swiss Precautionary Matrix (SPM), SimpleBox4Nano, Mend2Nano, NanoQSAR and SSWD.
Document(s): Download CALIBRATEFACSHEET_14_IDENTIFICATION OF DATA SETS FOR RISK GOVERNANCE TOOL PERFORMANCE TESTING.PDF (05.10.2019)
URL(s): Identification of data sets for risk governance tool performance testing (05.10.2019)
Reference name: caLIBRAte Factsheets
Description: The introduction of pores into silica nanoparticles holds promise for applications such as medical devices or catalysts. The introduction of copper doping potentially improves catalysis of nanomaterials. When manufacturing and utlilising these materials it is important to know at what levels they are toxic to workers. Also it is important to know at which levels such materials become toxic to the ecological environment. As part of the caLIBRAte project silica materials of various sizes—with or without porosity and copper doping—were manufactured. The materials were physico-chemically characterised and the toxicity of porous silica nanoparticles with or without copper doping was tested. For this, both cutting edge in cell culture in vitro methods, as well as gastrointestinal, pulmonary and ecotoxicity in vivo methods, were used.
Document(s): Download CALIBRATEFACSHEET_15_NEW TOXICITY KNOWLEDGE OF POROUS NANOPARTICLES AND NANOPARTICLES DOPED WITH COPPER.PDF (05.10.2019)
URL(s): New toxicity knowledge of porous nanoparticles and nanoparticles doped with copper (05.10.2019)
Reference name: caLIBRAte Factsheets
Description: Selected human and environmental risk analysis tools were performance tested before acceptance to the Nano Risk Governance Portal (NRGP). Value-chain case studies with high quality information were needed for testing and demonstrating of the modelling tools. Data quantifying the nanomaterial release, transformation, exposure and fate were necessary for performance testing, calibration and demonstration of exposure assessment models used in the NRGP. Existing case studies were comprehensively inventoried, the quality of their data was examined, the missing information (data gaps) identified and completed when applicable data was available. The results of this analysis were used to select the most relevant case-studies for performance testing of the models and for demonstration of the NRGP.
Document(s): Download CALIBRATEFACSHEET_16_EXPOSURE SCENARIOS AND DATA FOR PERFORMANCE TESTING OF H AND E MODELS.PDF (05.10.2019)
URL(s): Exposure scenarios and data for performance testing of H and E models (05.10.2019)
Reference name: caLIBRAte Factsheets
Description: Value-chain case-studies (CS) with relevant exposure scenarios (ES) containing data on human exposure and environmental release along the life cycle stages of nanomaterials (NMs) and nano-enabled products (NEPs) are of great importance for performance testing of the models selected within caLIBRAte because they provide measured data to be compared with modelling results. Data from different CS and related ES have been inventoried from selected data sources, including: i. Exposure databases (NECID, GUIDEnano library); ii. Data generated in EU Projects iii. Scientific literature. The information and data contained in the CS and their relevant ES were collected and analyzed, identifying both emerging knowledge gaps and missing data on human exposure and environmental release and fate studies.
Document(s): Download CALIBRATEFACSHEET_17_HUMAN EXPOSURE AND AND ENVIRONMENTAL RELEASE DATA FOR MODELS PERFORMANCE TESTING.PDF (05.10.2019)
URL(s): Human exposure and and environmental release data for models performance testing (05.10.2019)
Reference name: caLIBRAte Factsheets
Description: Within caLIBRAte, value-chain case-studies were collected and generated with a twofold purpose: model performance testing and demonstration of the usability of the risk assessment (RA) models included in the caLIBRAte Nano Risk Governance Portal (NRGP).
Document(s): Download CALIBRATEFACSHEET_18_COMPILATION OF SUITABLE VALUE CHAIN CASE STUDIES FOR DEMONSTRATION OF THE NRGP.PDF (05.10.2019)
URL(s): Compilation of suitable value chain case studies for demonstration of the NRGP (05.10.2019)
Reference name: caLIBRAte Factsheets
Description: One goal of the caLIBRAte project was to test the sensitivity and performance of Nanomaterial (NM) risk, exposure and hazard assessment models. To carry out this task and to implement a feasible and efficient methodological testing approach, information was needed on model input requirements along with data formats. This included technical information on 20 models identified in early stage of the caLIBRAte project. Generation of such information was the first step on the road to implementing the sensitivity testing and data gap analysis in caLIBRAte.
Document(s): Download CALIBRATEFACSHEET_19_INPUT REQUIREMENTS AND DATA FORMATS OF NANOMATERIALS RISK ASSESSMENT TOOLS.PDF (05.10.2019)
URL(s): Input requirements and data formats of Nanomaterials risk assessment tools (05.10.2019)
Reference name: caLIBRAte Factsheets
Description: Establishment of a web-based nano-risk governance portal with well-documented tools and guidance is one of the key products of the caLIBRAte project. An important part of this work is the testing and calibration of the nanomaterial (NM) risk assessment tools and models. This includes sensitivity analysis on 11 nanomaterial risk, exposure and hazard assessment models. The testing methods included One-at-a-time (OAT), Monte-Carlo, and tailored regression analysis and diagnostic methods. The aim of the testing was to find the input parameters that show no, lowest or highest sensitivity. Furthermore, the aim was to find if there is any unexpected behavior of the models.
Document(s): Download CALIBRATEFACSHEET_20_INPUT VALUE SENSITIVITY OF NANOMATERIAL RISK, EXPOSURE AND HAZARD ASSESSMENT TOOLS.PDF (05.10.2019)
URL(s): Input value sensitivity of Nanomaterial risk, exposure and hazard assessment tools (05.10.2019)

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