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Diss Factsheets

Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Data is from auhtortative database

Data source

Reference
Reference Type:
other: Gestis
Title:
Gene mutation toxicity study of the test chemical
Author:
Institute for Occupational Safety and Health of the German Social Accident Insurance
Year:
2016
Bibliographic source:
Gestis

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Principles of method if other than guideline:
Gene mutation toxicity study was performed to determine the mutagenic nature of the test chemical
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
1-bromo-4-fluorobenzene
EC Number:
207-300-2
EC Name:
1-bromo-4-fluorobenzene
Cas Number:
460-00-4
Molecular formula:
C6H4BrF
IUPAC Name:
1-bromo-4-fluorobenzene
Details on test material:
- Name of test material: 1-bromo-4-fluorobenzene
- IUPAC name: 1-Bromo-4-fluorobenzene
- Molecular formula: C6H4BrF
- Molecular weight: 175.0 g/mol
- Smiles: c1(ccc(Br)cc1)F
- InChI: 1S/C6H4BrF/c7-5-1-3-6(8)4-2-5/h1-4H
- Substance type: Organic
- Physical state: Liquid (clear colorless)

Method

Target gene:
Histidine
Species / strain
Species / strain / cell type:
other: Salmonella typhimurium
Details on mammalian cell type (if applicable):
Not applicable
Additional strain / cell type characteristics:
not specified
Cytokinesis block (if used):
No data
Metabolic activation:
with and without
Metabolic activation system:
No data
Test concentrations with justification for top dose:
Concentrations up to growth inhibition and cell toxicity
Vehicle / solvent:
No data
Controls
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
not specified
True negative controls:
not specified
Positive controls:
not specified
Positive control substance:
not specified
Details on test system and experimental conditions:
No data
Rationale for test conditions:
No data
Evaluation criteria:
Increase in the number of revertants/dose
Statistics:
No data

Results and discussion

Test results
Species / strain:
S. typhimurium, other: Salmonella typhimurium
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified
Additional information on results:
No data
Remarks on result:
other: No mutagenic potential

Applicant's summary and conclusion

Conclusions:
The test chemical did not induce gene mutation in the Salmonella typhimurium in the presence and absence of S9 metabolic activation system and hence is not likely to classify as a gene mutant in vitro.
Executive summary:

Gene mutation toxicity study was performed to determine the mutagenic nature of the test chemical using Salmonella typhimurium both in the presence and absence of metabolic activation system. The test chemical did not induce gene mutation in the Salmonella typhimurium in the presence and absence of S9 metabolic activation system and hence is not likely to classify as a gene mutant in vitro.