Registration Dossier

Classification & Labelling & PBT assessment

GHS

General Information

Name:
slimes and sludges, electrolyitc refining of tin, lead and silver containing alloy
Implementation:
EU
Type of classification:
self-classification
Remarks:

Classification is calculated with MeClas tool (http://www.meclas.eu) based on classification of the individual constituents andusing available data from elemental composition and available information on mineralogy (see attachment).

General approach

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 constituents.

 

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 

  • iUVCB variability (elemental concentration),the physical form (e.g. massive, powder),
  • the physical form (e.g. massive, powder), the hazard profile for all the elemental constituents, and
  • the hazard profile for all the elemental constituents,
  • and the speciation of the constituents (and the uncertainty associated if partly unknown the speciation of the constituents (and the uncertainty associated if partly unknown)

The official ECHA guidance (e.g. from the European Chemicals Agency, ECHA for the CLP[1]) 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,…).

  • When the speciation of the elemental constituent is known, it is used as such for the classification assessment of the iUVCB; when the speciation of the elemental constituent is unknown, the speciation with the worst-case classification is selected and assigned to the constituent for the iUVCB classification calculation.
  • The typical iUVCB variability in elemental constituents (i.e. wide range concentration of the iUVCB constituents) is assessed by selecting a worst-case concentration, which is defined as the maximum of all company typical concentrations for each constituent.

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 new streams.

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).

 

MeClas

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 complex iUVCBs

  • ensure consistent classification of complex iUVCBs throughout the industry

  • 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.

  • Confidentiality assurance for proprietary information: confidentiality of proprietary data is assured by having the ERVs for such substances hidden from normal users of the tool in a dedicated layer of MeClas.

Self-classification of the iUVCB substance was performedusing the MeClas toolbased on the following outline:

i. Characterisation

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.

iii. Bridging

(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 properties).

iv. Optional correction for bioavailability (Tier 2 in MeClas)

MeClas fulfills the OECD principles for validation of (Q)SARs model 

  1. Well defined end points
  2. Unambiguous algorithmfrom EU CLP Guidance: summation/additivity formula, to determine classification and, back-calculation (via Acute Toxicity Estimate formula, etc) to derive the corresponding toxicity of the substance
  3.  Clear applicability domain: applicable to classify complex metal containing materials in a Tiered approach (see EU CLP Guidance pg 499 Annex IV.5.5, and for conceptual outline ICMM Fact Sheet “Ores & Concentrates –An industry approach to EU hazard classification”, November 2009). Input information at tier 1: elemental composition and representative mineralogical information
  4. Mechanistic interpretation
  • Mechanistic interpretation - metal speciation:

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 correction.

  • Mechanistic interpretation - metal-ion additivity for environment:

(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 2009. 

 

[1]ECHA, 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.

Related composition

Related composition:
Composition 1
Composition 3

Classificationopen allclose all

Explosives
Reason for no classification:
conclusive but not sufficient for classification
Flammable gases and chemically unstable gases
Reason for no classification:
conclusive but not sufficient for classification
Aerosols
Reason for no classification:
conclusive but not sufficient for classification
Oxidising gases
Reason for no classification:
conclusive but not sufficient for classification
Gases under pressure
Reason for no classification:
conclusive but not sufficient for classification
Flammable liquids
Reason for no classification:
conclusive but not sufficient for classification
Flammable solids
Hazard category:
Flam. Solid 1
Hazard statement:
H228: Flammable solid.
Self-reactive substances and mixtures
Reason for no classification:
conclusive but not sufficient for classification
Pyrophoric liquids
Reason for no classification:
conclusive but not sufficient for classification
Pyrophoric solids
Reason for no classification:
conclusive but not sufficient for classification
Self-heating substances and mixtures
Hazard category:
Self Heat. 1
Hazard statement:
H251: Self-heating: may catch fire.
Substances and mixtures which in contact with water emit flammable gases
Reason for no classification:
conclusive but not sufficient for classification
Oxidising liquids
Reason for no classification:
conclusive but not sufficient for classification
Oxidising solids
Reason for no classification:
conclusive but not sufficient for classification
Organic peroxides
Reason for no classification:
conclusive but not sufficient for classification
Corrosive to metals
Reason for no classification:
conclusive but not sufficient for classification
Desensitized explosives
Reason for no classification:
conclusive but not sufficient for classification
Acute toxicity - oral
Reason for no classification:
conclusive but not sufficient for classification
Acute toxicity - dermal
Reason for no classification:
conclusive but not sufficient for classification
Acute toxicity - inhalation
Reason for no classification:
conclusive but not sufficient for classification
Skin corrosion / irritation
Reason for no classification:
conclusive but not sufficient for classification
Serious eye damage / eye irritation
Hazard category:
Eye Damage 1
Hazard statement:
H318: Causes serious eye damage.
Respiratory sensitisation
Reason for no classification:
conclusive but not sufficient for classification
Skin sensitisation
Hazard category:
Skin Sens. 1
Hazard statement:
H317: May cause an allergic skin reaction.
Aspiration hazard
Reason for no classification:
conclusive but not sufficient for classification
Reproductive toxicity
Hazard category:
Repr. 1A
Hazard statement:
H360: May damage fertility or the unborn child <state specific effect if known > <state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard>.
Effects on or via lactation
Hazard category:
Effect on or via lactation
Hazard statement:
H362: May cause harm to breast-fed children.
Germ cell mutagenicity
Reason for no classification:
conclusive but not sufficient for classification
Carcinogenicity
Hazard category:
Carc. 1A
Hazard statement:
H350: May cause cancer <state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard>.
1. Specific target organ toxicity - single
Reason for no classification:
conclusive but not sufficient for classification
1. Specific target organ toxicity - repeated
Hazard category:
STOT Rep. Exp. 1
Hazard statement:
H372: Causes damage to organs <or state all organs affected, if known> through prolonged or repeated exposure <state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard>.
Affected organs:
The central nervous system, kidneys and haematological (blood) systems
Hazardous to the aquatic environment (acute / short-term)
Hazard category:
Aquatic Acute 1
Hazard statement:
H400: Very toxic to aquatic life.
Hazardous to the aquatic environment (long-term)
Hazard category:
Aquatic Chronic 1
Hazard statement:
H410: Very toxic to aquatic life with long lasting effects.
Hazardous to the ozone layer
Reason for no classification:
data lacking

Labelling

Signal word:
Danger

Hazard pictogram

GHS02: flame
GHS05: corrosion
GHS07: exclamation mark
GHS08: health hazard
GHS09: environment

Hazard statements

H228: Flammable solid.
H251: Self-heating: may catch fire.
H318: Causes serious eye damage.
H317: May cause an allergic skin reaction.
H350: May cause cancer <state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard>.
H360: May damage fertility or the unborn child <state specific effect if known > <state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard>.
H362: May cause harm to breast-fed children.
H372: Causes damage to organs <or state all organs affected, if known> through prolonged or repeated exposure <state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard>.
H400: Very toxic to aquatic life.
H410: Very toxic to aquatic life with long lasting effects.

Precautionary statements

P403+P235: Store in a well-ventilated place. Keep cool.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P201: Obtain special instructions before use.
P260: Do not breathe dust/fume/gas/mist/vapours/spray.
P270: Do no eat, drink or smoke when using this product.
P308+P313: IF exposed or concerned: Get medical advice/attention.
P501: Dispose of contents/container to ... …in accordance with local/regional/national /international regulations (to be specified). Manufacturer/supplier or the competent authority to specify whether disposal requirements apply to contents, container or both.
P273: Avoid release to the environment.

Notes