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For the short-term toxicological endpoints (acute toxicity, skin-eye
corrosion, sensitization, mutagenicity), the classification is based on
test data. For all other endpoints (human health, environment), the
classification is calculated with the MeClas tool
(http://www.meclas.eu), i.e. based on classification of the individual
constituents and using available data from elemental composition
and available information on speciation.
An iUVCB substance is a complex
substance. Its main characteristics are a known but variable elemental
composition and the -in some cases- partly unknown speciation of the
The classification of the iUVCB is based
on the hazard of its constituents and the classification rules for the
hazard assessment of mixtures under the UN Globally Harmonised System
(GHS) and its EU implementation (CLP). To derive the iUVCB
classification, one therefore needs to have information on
The official ECHA guidance (e.g. from the European Chemicals
Agency, ECHA for the CLP)
is used as basis for the assessment and includes metal-specific guidance.
The unknown constituents speciation and
elemental variability are addressed following a precautionary and
conservative approach. In practice:
The starting point is the iUVCB
composition (as defined in IUCLID 1.2): the composition is provided
listing variability (i.e. concentration range) including the available
information on the chemical speciation of each constituent (i.e.
specifying whether analytical tests could identify if the element is
present as oxide, sulfide,…).
Within one iUVCB substance, the variability in elemental
composition can potentially lead to different hazard profiles.
Therefore, there can be a practical need (for the purpose of SDS and
labelling) to differentiate more hazardous from less hazardous
individual streams within the iUVCB. Generic groups/grades/clusters
within one iUVCB - each group with a common worst-case classification
profile – can be developed and reported in IUCLID to increase general
understanding of the variability of the hazard of the iUVCB and to allow
registrants to easily derive a worst-case classification for possible
The MeClas tool (www.meclas.eu) has been
developed to facilitate the classification of complex inorganic
materials, considering the aspects raised above) is used. The tool
allows the use of constituent specific information to derive iUVCB
classification based on mixture rules (CLP).
The classification of iUVCBs is assessed
using the MeClas tool (Metal Classification tool,www.meclas.eu).
MeClas was developed to:
deal with the complexity of the hazard classification of
ensure consistent classification of complex iUVCBs throughout
provide full recognition to metal specific aspects
provide a platform for relevant data centralisation between
metal consortia (self-classifications and (eco)toxicity reference
values) and between metal consortia and companies (read-across of
speciation and bio-availability tests)
The tool allows the use of constituent specific information to
derive iUVCB classification based on mixture rules (CLP).
MeClas is therefore facilitating the hazard
identification for complex metal materials under CLP/ DSD/GHS throughout
the metal industry.
MeClas is built on a limited number of simple
and basic principles:
A tiered and inorganic specific approach, allowing refinement
in accordance with the following (not necessarily sequential)
steps/and available information:
Tier 0: elemental concentrations only (and worst-case
speciation and worst-case 100% solubility)
Tier 1: speciation data and mineralogical evidence
Tier 2: correction based on release/solubility test data on
the complex material
An up-to-date database including the official EU harmonised
(Annex VI of the CLP and subsequent ATPs) and self-classifications,
specific concentration limits, M-factors, (eco)toxicity reference
values (ERVs) values,…
An open building block structure, enabling the inclusion of
specific side modules if relevant (e.g. for ores and concentrates,
for transport classification, additional reference lists (e.g.
Japan), alloys, etc.). The core engine contains the UN-GHS, CLP (and
DSD/DPD) hazard ID rulings, forming the base of the MeClas tool.
Self-classification of the iUVCB substance
was performedusing the MeClas toolbased
on the following outline:
The material is accurately described from its
elemental composition (typical concentrations and concentration ranges
across production sites –IUCLID Section 1.2), and the specific
speciation data (mineralogical information, hazard) obtained from
representative samples. This information is estimated sufficient to
initiate the classification process.
ii. Classification by the Mixture Approach
The iUVCB is treated as a complex metal
containing substance with a number of discrete constituents (i.e.
chemical element with discrete speciation).
The hazard classifications of each compound are then factored into a
combined classification of the iUVCB as a whole. For health endpoints,
iUVCB classifications are based on the combined hazards of the compounds
(i.e. chemical element with discrete
speciation) whereby additivity or key
cut off levels, specified in look-up tables are used, depending on the
endpoint and amount of information available for the constituting
compounds. These concepts and rules are incorporated in the MeClas tool.
(Eco)-toxicological data are not available
for the specific iUVCBs being evaluated. Considering the knowledge and
variability in composition, read-across and bridging are done by using a
"representative" mineralogical/speciation analysis" combined with the
"worst case" elemental concentration (across companies) as a basis for
the classification of the iUVCB substance (chemical and mineralogical
surrogates with similar origin/production process and physical/chemical
iv. Optional correction for
bioavailability (Tier 2 in MeClas)
MeClas fulfills the OECD principles for
validation of (Q)SARs model
The tool translates the
elemental composition into a mineralogical composition relevant for
classification (i.e. mineralogical distribution pattern for each
element/constituent of the iUVCB substance).
In the Tier 1, the classification is derived
(by means of the summation formula) without taking into account any
bioavailability correction. In
the Tier 2, the classification is derived (e.g. for environment by means
of the additivity formula) taking into account bioavailability
(1) The additivity
assumption for the toxicity of mixtures of metals was evaluated by C.
Nys, TVan Regenmortel, CR
Janssen, K Oorts, E Smolders & KAC De Schamphelaere, (2018). A framework
for ecological risk assessment of metal mixtures in aquatic systems.
(Environ. Toxicol. Chem. 37, 623–642).The
additivity mode was judged conservative for the prediction of the
toxicity of metal mixture at low effect concentrations in a
meta-analysis of chronic metal mixture toxicity to freshwater organisms.
(2) A. Stockdale, E Tipping, S Lofts & SJ
Ormod, combined metal speciation to the additive toxicity approach and predicted
the combined metal toxicity in a range of UK river systems impacted by
metals: in "Modeling multiple metal toxic effects in the field -
evaluation of the Toxicity Binding Model (TBM) ", ICA Report November
July 2017. Guidance on the Application of the CLP Criteria. Guidance
to Regulation (EC) No 1272/2008 on classification, labelling and
packaging (CLP) of substances and mixtures.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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