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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)
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.
GLP compliance:
not specified
Remarks:
GLP compliance not necessary for calculation method
Type of assay:
other: prediction from hazard class

Test material

Constituent 1
Reference substance name:
Calcines, zinc ore-conc.
EC Number:
273-776-3
EC Name:
Calcines, zinc ore-conc.
Cas Number:
69012-79-9
Molecular formula:
Not available, UVCB substance.
IUPAC Name:
Product of the reaction of zinc ore concentrates with air at high temperature, consisting mainly of ZnO, ZnFeO2, a composite of metallic oxides and some residual sulfides and sulphates.
Test material form:
solid: bulk
Details on test material:
The substance was tested as powder.

Results and discussion

Remarks on result:
not measured/tested
Remarks:
Based on MeClas calculation

Any other information on results incl. tables

According to MeClas, the substance is not classified as germ cell mutagen.

Applicant's summary and conclusion

Conclusions:
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 not 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.