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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
calculation (if not (Q)SAR)
Remarks:
Migrated phrase: estimated by calculation
Adequacy of study:
key study
Reliability:
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
Reference Type:
other: software
Title:
Unnamed
Year:
2018

Materials and methods

Principles of method if other than guideline:
Genetic toxicity potential of the UVCB potential was determined by classifying based on Mixture rules from EU CLP (additivity formula of classified components to derive hazard class). The classification criteria were used to estimate effects.
Type of assay:
other: prediction from hazard class

Test material

Constituent 1
Reference substance name:
Cement copper
EC Number:
266-964-1
EC Name:
Cement copper
Cas Number:
67711-88-0
Molecular formula:
UVCB substance
IUPAC Name:
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

Test results
Species / strain:
other: not tested
Metabolic activation:
not applicable
Genotoxicity:
other: not tested
Cytotoxicity / choice of top concentrations:
other: not tested
Vehicle controls validity:
not applicable
Untreated negative controls validity:
not applicable
Positive controls validity:
not applicable

Any other information on results incl. tables

According to MeClas, the substance is classified as Cat. 2 - H341 mutagen.

Applicant's summary and conclusion

Conclusions:
Interpretation of results: positive

Good quality study with result derived on basis of the Classification outcome (Mixture toxicity rules) from the reasinable worst case sample of the substance (maximum of typicals across industry as defined in IUCLID section 1.2/4.23). The analysed UVCB sample is classified for germ cell mutagenicity.
Executive summary:

The study provided a conservative estimate, 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.

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