Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Complex substance containing metals.  
The classification is based on assessment of the components, treating it as a mixture.
Considered to be harmful if ingested and inhaled.

Key value for chemical safety assessment

Additional information

Results from calculated classification (using mixture toxicity rules) are supported (WoE) by additional consideration from phys chem properties of the UVCB substance.

Chemistry and mineralogy of the material (see IUCLID section 4.23) were taken into account. Information regarding the physical form was gathered through proformas (see IUCLID section 4.1). Water solubility (see IUCLID section 4.8) furthermore confirmed species present and their solubility behaviour.

Justification for classification or non-classification

The substance is classified as

"Acute toxicity-oral Category 4; H302" resulting in an Acute Toxicity Estimate (ATE) of 500 mg/kg bodyweight

and

"Acute toxicity - inhalation Category 4; H332" resulting in an Acute Toxicity Estimate (ATE) of 4500 ppmV

The analysed sample is representative for the reasonable worst case sample of the substance (maximum of the typicals across industry of each constituent, defined within the concentration ranges outlined under IUCLID section 1.2).

Self-classification of the UVCB substance (IUCLID Section 2.1 & 2.2) was performed based on below outline:

1. Characterization

The material is accurately described from its elemental composition (maximum of typical concentrations and concentration ranges across industry –IUCLID Section 1.2) and the specific speciation data (mineralogical information) obtained from one or more representative sample(s) (IUCLID Section 4.23). This information is enough to initiate the classification process.

2. Classification by the Mixture Approach

The UVCB is treated as a complex metal containing substance with a number of discrete constituting compounds (metals, metal compounds, non-metal inorganic compounds). The hazard classifications of each compound is then factored into a combined classification of the UVCB as a whole (application CLP mixture rules).For health endpoints, UVCB classifications are based on the combined hazards of the compounds 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.For environmental endpoints, additivity and/or summation algorithms are applied to quantitatively estimate the mixture’s toxicity to aquatic organisms. These concepts and rules are incorporated in easy to use IT tools (e.g. ARCHE CLP tool), which can be used to classify the UVCB.

3. Bridging or Read-Across

(Eco)-toxicological data are not available for the specific UVCB being evaluated. Considering the knowledge and variability in composition, read-across and bridging is done by using  a "representative mineralogical/speciation analysis" (chemical and mineralogical surrogates with similar origin/production process and physical/chemical properties combined with the "maximum of the typicals" across industry for every constituent of the UVCB as a basis.

 

4. Eventual correction

No correction for (bio)availability was made.