Registration Dossier

Diss Factsheets

Administrative data

acute toxicity: oral
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:
accepted calculation method
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 oral toxicity potential of the UVCB substance was determined by classifying based on 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:
> 5 - <= 50 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 classified as Acute toxicity Oral Category 2 - H300.

Based on this result, the related criteria provided the estimated value for acute toxicity-oral (Acute Toxicity Point Estimate) (see EU CLP Guidance Annex I Table 3.1.2): 5 mg/kg bodyweight.

Applicant's summary and conclusion

Good quality estimate of the Acute Toxicity Estimate (ATE) -oral of the UVCB substance.
The substance is classified as acute toxic resulting in an ATE of 5 mg/kg bodyweight.
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.