Registration Dossier

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information
The variation L173 was tested for genetic toxicity in vitro. The substance lutetium aluminium oxide, cerium and gallium doped, garnet is completely insoluble in water, DMSO, ethanol, acetone, tetrahydrofurane or isopropanol. It is not bioavailable for the bacterial cell.
Link to relevant study records
Reference
Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2015-08-04 to 2015-08-11
Reliability:
1 (reliable without restriction)
Reason / purpose:
reference to other study
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
yes
Remarks:
Study not completed due to insolubility of the tested substance
GLP compliance:
yes (incl. certificate)
Type of assay:
bacterial reverse mutation assay
Target gene:
not applicable as study not completed
Test concentrations with justification for top dose:
not applicable as study not completed
Vehicle / solvent:
not applicable as study not completed
Details on test system and experimental conditions:
not applicable as study not completed
Evaluation criteria:
not applicable as study not completed
Statistics:
not applicable as study not completed
Species / strain:
other: not applicable as study not completed
Metabolic activation:
not applicable
Genotoxicity:
negative
Remarks:
The substance is completely insoluble in water, DMSO, ethanol, acetone, tetrahydrofurane or isopropanol. It is not bioavailable for the bacterial cell.
Cytotoxicity / choice of top concentrations:
other: not applicable as study not completed
Vehicle controls validity:
other: not applicable as study not completed
Untreated negative controls validity:
other: not applicable as study not completed
Positive controls validity:
other: not applicable as study not completed
Additional information on results:
not applicable as study not completed
Remarks on result:
other: other: not applicable as study not completed
Remarks:
Migrated from field 'Test system'.

The study was not completed due to the insolubility of the test item.

Conclusions:
Interpretation of results (migrated information):
negative

The substance is not capable of show ing mutagenic activity in a GLP-guideline study according to OECD 471 (Ames-test).
Executive summary:

The substance is completely insoluble in water, DMSO, ethanol, acetone, tetrahydrofurane or isopropanol. Due to the chemical nature of the substance only acid hydrolysis or similar decomposition methods would result in soluble matter.

Testing of the substance as a suspension is not in line with the guideline. Results produced with suspensions are usually not accepted by authorities.

The substance is not bioavailable for the bacterial cell in the Ames test or other in vitro test methods due to its insolubility. The substance is not capable of interfering with the genome in the bacterial cell. Hence, the Ames-test is negative as a basic principle.

The same applies for potential mutagenic activity under natural conditions.

Testing for genetic toxicity in vitro was aimed for but was technically not possible. REACH Annex XI no. 2: "Testing for a specific endpoint may be omitted, if it is technically not possible to conduct the study as a consequence of the properties of the substance..."

 

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Additional information

Additional information from genetic toxicity in vitro:

The substance is completely insoluble in water, DMSO, ethanol, acetone, tetrahydrofurane or isopropanol. Due the chemical nature of the substance only acid hydrolysis or similar decomposition methods would result in soluble matter.

Testing of the substance as a suspension is not in line with the guideline. Results produced with suspensions are usually not accepted by authorities.

The substance is not bioavailable for the bacterial cell in the Ames test or other in vitro test methods due to its insolubility. The substance is not capable of interfering with the genome in the bacterial cell. Hence, the Ames-test is negative as a basic principle.

The same applies for potential mutagenic activity under natural conditions.

The same profile of genetic toxicity is expected for all variations of the substance lutetium aluminium oxide, cerium and gallium doped, garnet.

Testing for genetic toxicity in vitro was aimed for but was technically not possible. REACH Annex XI no. 2: "Testing for a specific endpoint may be omitted, if it is technically not possible to conduct the study as a consequence of the properties of the substance..."


Justification for selection of genetic toxicity endpoint
Available study

Justification for classification or non-classification

Testing for genetic toxicity in vitro was aimed for but was technically not possible. REACH Annex XI no. 2: "Testing for a specific endpoint may be omitted, if it is technically not possible to conduct the study as a consequence of the properties of the substance..."

As discussed, the substance has to be considered as negative as regards genetic toxicity in vitro.

The same profile of genetic toxicity is expected for all variations of the substance lutetium aluminium oxide, cerium and gallium doped, garnet-