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EC number: 201-484-8 | CAS number: 83-53-4
Toxicological information
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 1,4-dibromonaphthalene
- EC Number:
- 201-484-8
- EC Name:
- 1,4-dibromonaphthalene
- Cas Number:
- 83-53-4
- Molecular formula:
- C10H6Br2
- IUPAC Name:
- 1,4-dibromonaphthalene
Constituent 1
Method
- Target gene:
- Histidine (for Salmonella typhimurium) and Tryptophane (for Escherichia coli)
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 fraction, microsome fraction prepared from Sprague Dawley rat liver homogenate
- Test concentrations with justification for top dose:
- 50, 150, 500, 1500 and 5000 ug/plate
- Vehicle / solvent:
- DMSO
Controls
- Untreated negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 7,12-dimethylbenzanthracene
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- other: 2-anthramine and cis-Platinum (II) Diammine Dichloride
- Details on test system and experimental conditions:
- The genotype of bacterial strains is checked:
-Histidine and tryptophane requirements with cultures in presence and in absence of L-histidine and L-triptophane for Salmonella typhimurium and Escherichia coli strains respectively.
-Loss of cell wall LPS (rfa mutation) measuring crystal violet inhibition for Salmonella typhimurium strains.
-Ampicillin resistance for the strains which have the pKM 101 plasmide.
-delta-uvr B mutation i.e. U.V.B sensitivity for Salmonella typhimurium and delta-uvr A mutation i.e. U.V.A sensitivity for Escherichia coli.
-Spontaneous revertant rate.
-Sensitivity to reference mutagens - Evaluation criteria:
- Ensure that the criteria of validity of the study are well respected namely :
- the bacteriostatic activity of the highest concentration tested shall be equal to or less than 75 %,
- the spontaneous reversion rate of the absolute negative control shall comply with the historical values of the laboratory,
- the spontaneous reversion rate of the solvent shall not be statistically different from absolute negative control,
- the mean number of revertant colonies obtained for each strain and the corresponding positive control, with and/or without metabolic activation shall comply with the historical values of the laboratory.
- Negative and positive values should not show significant difference with the historical values of the laboratory (± 2 standard deviations).
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A pKM 101
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Doses (5 000, 1 500, 500, 150 and 50 μg/plate) prepared from solutions of the test item 1,4-DIBROMONAPHTHALENE do not induce any mutagenic change in Salmonella typhimurium TA 1535, TA 1537, TA 98, TA 100 and in Escherichia coli WP2(uvrA¯) (pKM 101) without, or with metabolic activation, according to the OECD Guidelines n° 471.
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