Registration Dossier
Registration Dossier
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EC number: 686-526-7 | CAS number: 171611-11-3
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2017.10.24-2018.1.25
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Lithium bis(fluorosulfonyl)imide
- EC Number:
- 686-526-7
- Cas Number:
- 171611-11-3
- Molecular formula:
- F2 H N O4 S2 . Li
- IUPAC Name:
- Lithium bis(fluorosulfonyl)imide
- Test material form:
- solid: bulk
Constituent 1
- Specific details on test material used for the study:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
bacteria
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- 313, 625, 1250, 2500, 5000 μg/plate (TA98, TA100, TA1535, TA1537, WP2uvrA)
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
Applicant's summary and conclusion
- Conclusions:
- The number of revertant colonies in the negative (vehicle) control and positive control groups
in the present study were within the acceptable ranges stipulated at the testing facility. The
positive controls used in the assays with the presence or absence of S9 mix showed clear
positive responses by the respective test strains, as evidenced by the number of revertant
colonies being greater than 2-fold of the respective negative (vehicle) control value.
From the results described above, it was concluded that LiFSI was not mutagenic (negative)
under the conditions employed in the present study.
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