Registration Dossier

Classification & Labelling & PBT assessment

GHS

General Information

Name:
Germanium, germanium hydroxide oxides and amorphous silica, recovery products from germanium refining
Implementation:
EU
Remarks:

Classification is calculated with MeClas tool (http://www.meclas.eu) based on classification of the individual constituents and using 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).

 

Chapter 3.0.2. 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 performed using the MeClas tool based 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 algorithm from 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 p 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, T Van 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:
Germanium, germanium hydroxide oxides and amorphous silica, recovery products from germanium refining

Classificationopen allclose all

Explosives
Reason for no classification:
data conclusive but not sufficient for classification
Flammable gases and chemically unstable gases
Reason for no classification:
data lacking
Aerosols
Reason for no classification:
data lacking
Reason for no classification:
hazard class not assessed
Oxidising gases
Reason for no classification:
data lacking
Gases under pressure
Reason for no classification:
data lacking
Flammable liquids
Reason for no classification:
data lacking
Flammable solids
Reason for no classification:
data conclusive but not sufficient for classification
Self-reactive substances and mixtures
Reason for no classification:
data lacking
Pyrophoric liquids
Reason for no classification:
data lacking
Pyrophoric solids
Reason for no classification:
data lacking
Self-heating substances and mixtures
Reason for no classification:
data lacking
Substances and mixtures which in contact with water emit flammable gases
Reason for no classification:
data lacking
Oxidising liquids
Reason for no classification:
data lacking
Oxidising solids
Reason for no classification:
data conclusive but not sufficient for classification
Organic peroxides
Reason for no classification:
data lacking
Corrosive to metals
Reason for no classification:
data lacking
Desensitized explosives
Reason for no classification:
data lacking
Acute toxicity - oral
Reason for no classification:
data conclusive but not sufficient for classification
Acute toxicity - dermal
Reason for no classification:
data conclusive but not sufficient for classification
Acute toxicity - inhalation
Reason for no classification:
data conclusive but not sufficient for classification
Skin corrosion / irritation
Reason for no classification:
data 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:
data lacking
Skin sensitisation
Reason for no classification:
data conclusive but not sufficient for classification
Aspiration hazard
Reason for no classification:
data lacking
Reproductive toxicity
Hazard category:
Repr. 2
Hazard statement:
H361: Suspected of damaging 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>.
Route of exposure:
oral
Effects on or via lactation
Reason for no classification:
data lacking
Germ cell mutagenicity
Reason for no classification:
data conclusive but not sufficient for classification
Carcinogenicity
Reason for no classification:
data conclusive but not sufficient for classification
1. Specific target organ toxicity - single (STOT-SE)
Reason for no classification:
data conclusive but not sufficient for classification
1. Specific target organ toxicity - repeated (STOT-RE)
Hazard category:
STOT Rep. Exp. 2
Hazard statement:
H373: May cause 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:
other: kidneys
Route of exposure:
inhalation
oral
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 3
Hazard statement:
H412: Harmful to aquatic life with long lasting effects.
Hazardous to the ozone layer
Reason for no classification:
data lacking

Labelling

Signal word:
Danger

Hazard pictogram

GHS05: corrosion
GHS08: health hazard
GHS09: environment

Hazard statements

H318: Causes serious eye damage.
H361: Suspected of damaging 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>.
H373: May cause 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.
H412: Harmful to aquatic life with long lasting effects.

Precautionary statements

P280: Wear protective gloves/protective clothing/eye protection/face protection/hearing protection/...
P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P310: Immediately call a POISON CENTER/doctor/…
P202: Do not handle until all safety precautions have been read and understood.
P260: Do not breathe dust/fume/gas/mist/vapours/spray.
P273: Avoid release to the environment.
P391: Collect spillage.

Notes