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
Reliability:
other: All information in this endpoint has been provided by the ECHA using the 12 year rule, this is data is not owned by the registrant. The reliability is estimated to be at level 2 at a minimum.
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
All information in this endpoint has been provided by the ECHA using the 12 year rule, this is data is not owned by the registrant. The reliability is estimated to be at level 2 at a minimum. Therefore the reliability statement below can be used: Study conducted in accordance with generally accepted scientific principles, possibly with incomplete reporting or methodological deficiencies, which do not affect the quality of relevant results.

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
not specified
Qualifier:
according to
Guideline:
EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
Deviations:
not specified
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
This information not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA

Method

Target gene:
This information not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA
Species / strain
Species / strain / cell type:
other: Salmonella typhimurium TA98, TA100, TA1535, TA1537, TA 1538 and Escherichia coli WP2uvrA-
Metabolic activation system:
S9mix
Test concentrations with justification for top dose:
Concentration range in the main test (with metabolic activation): 100....5000 µg/plate
Concentration range in the main test (without metabolic activation): 100.......5000 µg/plate
Vehicle / solvent:
solvent(s) used: Dimethylsulphoxide (DMSO)
Controls
Untreated negative controls:
other: This information not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA
Negative solvent / vehicle controls:
other: This information not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA
True negative controls:
other: This information not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA
Positive controls:
other: This information not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA
Positive control substance:
other: This information not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA
Details on test system and experimental conditions:
Concentration of the test substance resulting in precipitation: 1000 µg/plate
Evaluation criteria:
This information not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA
Statistics:
This information not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA

Results and discussion

Test resultsopen allclose all
Species / strain:
other: as specified above
Metabolic activation:
with
Genotoxicity:
other: This information not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
> 5000 µg/plate
Vehicle controls validity:
other: This information not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA
Untreated negative controls validity:
other: This information not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA
Positive controls validity:
other: This information not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA
Species / strain:
other: as specified above
Metabolic activation:
without
Genotoxicity:
other: This information not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
>5000 µg/plate
Vehicle controls validity:
other: This information not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA
Untreated negative controls validity:
other: This information not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA
Positive controls validity:
other: This information not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA
Species / strain:
other: as specified above
Metabolic activation:
with
Genotoxicity:
other: This information not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
>5000 µg/plate
Vehicle controls validity:
other: This information not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA
Untreated negative controls validity:
other: This information not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA
Positive controls validity:
other: This information not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA
Remarks on result:
other: other: preliminary test
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation

The test material was negative for genetic mutation, with and without metabolic activation, in an Ames study.
Executive summary:

All information in this endpoint has been provided by the ECHA using the 12 year rule, this is data is not owned by the registrant.

Genetic mutation (in vitro) was examined by using OECD Guideline 401 (1981) Annex V - Method B14

T-1540N was demonstrated to be negative for genetic mutation, with and without metabolic activation.