Registration Dossier

Administrative data

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)
Cross-reference
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015
Report Date:
2015

Materials and methods

Test guideline
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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): L173
- Physical state: solid powder
- Analytical purity: > 99 %
- Impurities (identity and concentrations): not applicable
- Composition of test material, percentage of components: almost pure substance
- Expiration date of the lot/batch: does not expire
- Stability under test conditions: stable
- Storage condition of test material: room temperature

Method

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

Results and discussion

Test results
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'.

Any other information on results incl. tables

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

Applicant's summary and conclusion

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..."