Germanium hydroxide oxides, calcium sulfate, calcium carbonate, iron sulfide and amorphous silica, recovery products from germanium refining

Endpoint summary

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Genetic toxicity is driven by the characteristics of the individual UVCB constituents.
Relevant information on the individual UVCB constituents is reported in Section 7 Summary.

Link to relevant study records

Reference

Endpoint:

in vitro gene mutation study in bacteria

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:

other: Automatic calculation with MeCLas tool

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to other study

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

Remarks on result:

no mutagenic potential (based on QSAR/QSPR prediction)

Remarks:

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.

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

Conclusions:

Interpretation of results (migrated information):
negative

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (negative)