A "Hazard" is defined as the inherent capacity of a chemical or mixture to cause adverse effects in man or the environment under the conditions of exposure, and "hazard identification” as the identification of these adverse effects and the "estimation of the relationship between dose or level of exposure to a substance, and the incidence and severity of an effect" (Van Leeuwen and Vermeire, 2007). When evaluating hazards, it is important to consider:
- That some effects appear upon single ('acute’) exposure, whereas others require a long-term ('chronic') exposure; and
- The exposure routes (dermal, oral, inhalation) which may determine different toxic effects (only relevant for human health hazard identification).
Risk Management of Complex Inorganic Materials, Violaine Verougstraete, 2018
Guidance
Framework for Metals Risk Assessment (US EPA, 2007), Chp 4.3 - Human Health Risk Assessment for Metals, Hazard Characterization
The Framework for Metals Risk Assessment is a science-based document that addresses the special attributes and behaviours of metal substances and metal compounds to be considered when assessing their human health and ecological risks. The document describes basic principles to be considered in assessing risks posed by metal substances and is intended to foster consistency on how these principles are applied across the Agency’s programmes and regions when conducting these assessments.
4.3. Hazard characterisation:
- Mixtures and Interactions (4-14)
- Essentiality (4-16)
- Forms of Metals (4-18)
- Toxicokinetics/toxicodynamics - Absorption, Distribution, Metabolism, Excretion, Kinetic Modelling (4-20-22)
- Metal toxicity – Non-cancer effects of metals, Carcinogenic effects of Metals, Issues Related to evaluation of toxicity tests for metals (4-23-25)
- Dose-Response Assessment (4-26)
Guidance on grouping chemicals (2014, Chp 6.7: Metals and inorganics metal compounds) (OECD) pp100-101 (Grouping for human health endpoints)
This guidance document is part of the OECD effort to provide guidance for assessing the hazards of chemical substances while gaining efficiencies and improving animal welfare. The approach described in this guidance document is to consider closely related chemicals as a group, or category, rather than as individual substances. In the category approach, not every substance needs to be tested for every endpoint. Instead, the overall data for that category should prove adequate to support a hazard assessment. The overall data set must enable an estimate of hazard for the untested endpoints. This chapter is intended to supplement the general guidance in the previous chapters with issues specific to metal substances. It includes some metal-specific examples.
Hazard assessment of ores and concentrates for marine transport (ICMM, 2014)
This guidance provides assistance to metals and mining companies to meet their needs regarding the new marine transports’ regulations (such as MARPOL, IMSBC, IMDG). The document is currently under revision and a new version will be available soon.
Guidance on the classification of inorganic UVCB substances for human health hazards (EM, 2020)
This guidance document describes a tiered approach and its application to hazard classification of inorganic UVCB substances for human health hazards. The information necessary to conduct the assessment is identified at 3 levels: elemental composition, mineralogy / speciation, and information on bioaccessibility. This information is used to establish a hazard classification by treating the UVCB substance as if it were a mixture of its constituents.
Publications
Risk Management of Complex Inorganic Materials: A practical Guide (Violaine Verougstraete, 2018), Chp 3.2-4.2-8
The aim of this publication is to facilitate the hazard identification as part of risk assessment and management of complex inorganic materials around the world by providing accessible and specific guidance on their assessment. This book explains the main characteristics of inorganic complex materials affecting their hazard and risk assessment and management, including their source and main uses, also covering hazard and exposure assessment, risk characterisation and risk management.
It is an essential reference for regulators involved in risk assessment and risk management, industry experts charged with compliance of chemicals management programme requirements, consultants preparing chemicals management files for companies and regulators, and academics involved in research on complex inorganic materials.
Table of Contents:
- General introduction
- Sources of Exposure to inorganic complex materials
- Mechanisms Underlying Toxicity of Complex Inorganic Materials
- Principles of risk Assessment and Management of Complex Inorganic Materials
- Main characteristics of relevance for the assessment of complex inorganic materials
- Data needs, availability, sources and reliability
- Environmental Toxicity assessment of complex inorganic materials
- Human Health Toxicity assessment of complex inorganic materials
- Specific methodologies/tools to support assessment
- Hazard assessment of ores and concentrates
- Risk assessment of exposure to inorganic substances of UVCBs during manufacturing (recycling) of metals
- Risk assessment for manufacture and formulation of Inorganic Pigments (manufacturing and use)
- Risk assessment of alloys (manufacturing, use, end of life)
- Emerging tools in the assessment of metals: Current Applicability
ESAC Opinion on the Scientific Validity of the Bioelution Test Method
Bioelution aims at generating in vitro bioaccessibility data that can be used to (i) support grouping and read-across of inorganic metal compounds and metal (metalloid)-containing materials (e.g. UVCBs, pigments and alloys) and (ii) establish the presence or absence of a matrix effect by comparing the relative bioaccessible concentration of a metal in a metal-containing material (e.g. alloy) versus a reference material (e.g. a pure metal).
In 2019, EURL ECVAM (European Union Reference Laboratory for Alternatives to Animal Testing) asked its committee of experts (ESAC) to assess the scientific validity of the bioelution test method.
ESAC evaluated the biological relevance of the method, the relevance of the measurement of relative bioaccessible concentration and its reproducibility as well as the robustness of the protocol.
Based on the available information, the existing scientific literature and the scientific committee’s experience, ESAC concluded that :
- The Bioelution test method is biologically relevant
- The Bioelution test method is a simple, reproducible approach and is applicable to many metals
- The Bioelution test method is appropriate to assess if a matrix effect occurs in alloys
and hence recommended that the bioelution test method progresses to Test Guideline development at OECD level to achieve international harmonisation.
Classification
Both the UN GHS and the EU CLP assign hazard classifications to substances based on observed health effects (Hazard identification). For each health endpoint, more or less severe classifications are derived depending on the potency of the substance to cause an effect (e.g. acute toxicity) or depending on the sources and strength of the evidence for the effect (e.g. carcinogenicity).
Metal specificities can affect these classifications. E.g. tumours in rats, linked to particle effects after inhalation of inorganic insoluble dusts; classification of alloys based on bioelution data rather than nominal content.
Models
MECLAS (ARCHE, 2010-2016)
The MeClas tool allows classifying complex inorganic materials like ores and concentrates, complex intermediates, alloys or UVCBs, recognising the specific properties and assessment techniques for inorganics, using the most updated information on toxicity references and self-classifications available. The tool includes several tiers, aiming for a progressive refinement of the classification through recognition of speciation, specific mineral content and the availability of test data on the complex material in question.
The Classification mapping tool (EM)
Eurometaux has developed a Classification Mapping Tool, intended to support the identification of links between hazardous classifications, legislative provisions and industry impacts, as well as the evaluation of impacts associated to current, as well as potential future, hazardous (re)classifications. It contains information on approximately 60 EU directives/regulations covering: general measures, workers, consumers, environment and transport. It also provides indicative information on references associated to specific hazardous classifications, requirements, impacts on industry, derogations and legislative revisions.
In order to have access, please send an email to cmassistants3@gmail.com
Guidance
Ores and concentrates Guidance on EU Hazard Classification (ARCHE, ICMM )
Guidance document for the EU Hazard Classification of Ores and Concentrates (O&C) using the Global Harmonised System of classification and labelling of chemicals (GHS) criteria for both Human Health and environment classification.
Presentations
Bioelution-Based Approaches for Metals (ICMM presentation at APEC, Philippines, 2015)
- Link between bioavailability and toxicity: definitions and general bioelution principles
- Use of bioavailability in the regulatory framework (– Precedents for use of bioaccessibility data as surrogate for bioavailability in regulations – Grouping and read-across: Antimony (Sb), Nickel (Ni)– Classification of substances and mixtures
- Advantages and limitations of bioelution-based approaches
- Conclusions
MECLAS Tool for Complex Materials from the Metals Sector (ICMM presentation at APEC, Philippines, 2015)
Publication
Risk Management of Complex Inorganic Materials: A practical Guide (Violaine Verougstraete, 2018), Chp 13.3, p.220)
The aim of this publication is to facilitate the hazard identification as part of risk assessment and management of complex inorganic materials around the world by providing accessible and specific guidance on their assessment. This book explains the main characteristics of inorganic complex materials affecting their hazard and risk assessment and management, including their source and main uses, also covering hazard and exposure assessment, risk characterisation and risk management.
It is an essential reference for regulators involved in risk assessment and risk management, industry experts charged with compliance of chemicals management programme requirements, consultants preparing chemicals management files for companies and regulators, and academics involved in research on complex inorganic materials.
Table of Contents:
-
- General introduction
- Sources of Exposure to inorganic complex materials
- Mechanisms Underlying Toxicity of Complex Inorganic Materials
- Principles of risk Assessment and Management of Complex Inorganic Materials
- Main characteristics of relevance for the assessment of complex inorganic materials
- Data needs, availability, sources and reliability
- Environmental Toxicity assessment of complex inorganic materials
- Human Health Toxicity assessment of complex inorganic materials
- Specific methodologies/tools to support assessment
- Hazard assessment of ores and concentrates
- Risk assessment of exposure to inorganic substances of UVCBs during manufacturing (recycling) of metals
- Risk assessment for manufacture and formulation of Inorganic Pigments (manufacturing and use)
- Risk assessment of alloys (manufacturing, use, end of life)
- Emerging tools in the assessment of metals: Current Applicability