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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

acute toxicity: dermal
Type of information:
calculation (if not (Q)SAR)
Migrated phrase: estimated by calculation
Adequacy of study:
key study
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Automatic calculation with MeClas tool
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference Type:
other: software

Materials and methods

Principles of method if other than guideline:
Acute dermal toxicity potential of the UVCB substance was determined by classifying based on the Mixture rules from EU CLP (additivity formula of classified components to derive hazard class) and back calculation to the corresponding acute toxicity range estimate.

Test material

Constituent 1
Reference substance name:
Cement copper
EC Number:
EC Name:
Cement copper
Cas Number:
Molecular formula:
UVCB substance
Insoluble copper-containing residue after precipitation of copper bearing solutions
Details on test material:
The received 1kg samples were registered in Laboratory Information Management System (LIMS) when received with the required sample pre treatment and assays. The received samples range in form from fine- grained powders to crushed material and lumps, depending their origin. The powder and crushed sampled were treated as received, while the lumps were crushed 100 % - 3 mm in size.
The homogenized material was divided with rotary bottle splitter into 8 sub-samples for mineralogy by XRD and water solubility tests and TGA measurements. The flow- sheet of the characterization test work is shown in Figure 1 of the technical report by Outotec. . All the information related to sample preparation, assays and the results of assays and test are stored in LIMS. Samples for water solubility and oxidation / melting point determinations are registered in LIMS separately.
the substance was tested in its powder form.

Results and discussion

Effect levels
Dose descriptor:
other: acute toxicity estimate ATE
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: prediction

Any other information on results incl. tables

According to MeClas, the substance is not classified as Acute toxicity Dermal.

Applicant's summary and conclusion

Interpretation of results:
not classified
Migrated information
Executive summary:

The study provided a conservative estimate of the effect concentration, derived on basis of the classification outcome (mixture toxicity rules) from a reasonable worst-case sample of the substance using mineralogical information from the representative sample. 


Validity of the model used:

1. Defined endpoint: the endpoint is a REACH compliant defined endpoint

2. Unambiguous algorithm: EU CLP guidance based summation formula to determine classification, followed by back-calculation to related hazard criteria

3. Applicability domain: applicable to classify complex metal containing materials. 

4. Mechanistic interpretation - metal species: the tool translates the elemental composition into a mineralogical composition relevant for classification.