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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro cytogenicity / micronucleus study
Remarks:
prediction from hazard class
Type of information:
calculation (if not (Q)SAR)
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:
Leach residues, zinc ore, lead-contg.
EC Number:
293-314-4
EC Name:
Leach residues, zinc ore, lead-contg.
Cas Number:
91053-49-5
IUPAC Name:
silicon(4+) diiron(3+) dicopper(2+) hexazinc(2+) tetrahydrate hexahydroxide octaoxidandiide disulfate
Details on test material:
Reasonable worst-case across industry, as reported in Section 1.2.
Representative sample for mineralogical information is provided in IUCLID section 4.23.

Method

Species / strain
Species / strain / cell type:
other: standard species for the test

Results and discussion

Remarks on result:
not measured/tested
Remarks:
based on calculation

Any other information on results incl. tables

According to MeClas, the substance is classified as Cat. 1 - H340 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 reasonable 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.