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EC number: 216-437-7 | CAS number: 1584-62-9
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
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:
- 27.04.2017 - 06.06.2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 2-bromo-4'-chloro-2'-(o-fluorobenzoyl)acetanilide
- EC Number:
- 216-437-7
- EC Name:
- 2-bromo-4'-chloro-2'-(o-fluorobenzoyl)acetanilide
- Cas Number:
- 1584-62-9
- Molecular formula:
- C15H10BrClFNO2
- IUPAC Name:
- 2-bromo-4'-chloro-2'-(o-fluorobenzoyl)acetanilide
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 0190161002
- Expiration date of the lot/batch: 02.08.2019
- Purity test date: 17.03.2017
Method
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:
- phenobarbital/β-naphthoflavone induced rat liver S9
- Test concentrations with justification for top dose:
- Experiment I (Plate Incorporation):
All strains with/without S9 mix: 3; 10; 33; 100; 333; 1000; 2500; and 5000 μg/plate
Experiment II (Pre-Incubation):
All strains without S9 mix: 10; 33; 100; 333; 1000; 2500; and 5000 μg/plate
All strains with S9 mix: 1; 3; 10; 33; 100; 333; 1000; and 2500 μg/plate
The test item precipitated in the overlay agar in the test tubes from 100 to 5000 μg/plate with and without S9 mix in experiment I and in experiment II from 100 to 5000 μg/plate without S9 mix and from 333 to 2500 μg/plate with S9 mix. Precipitation of the test item in the overlay agar on the incubated agar plates was observed at a concentration of 333 μg/plate up to the highest investigated dose in both experiments with and without S9 mix. The undissolved particles had no influence on the data recording. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO; deionised water
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- methylmethanesulfonate
- other: 4-nitro-o-phenylene-diamine; 2-aminoanthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:
- Experiment I (Plate Incorporation)
- Experiment II (Pre-Incubation)
DURATION:
Experiment II:
- Preincubation period: 1 h
- Exposure duration: 48 h
NUMBER OF REPLICATIONS: 3
DETERMINATION OF CYTOTOXICITY
Toxicity of the test item can be evident as a reduction in the number of spontaneous revertants or a clearing of the bacterial background lawn. - Evaluation criteria:
- A test item is considered as a mutagen if a biologically relevant increase in the number of revertants exceeding the threshold of twice (strains TA 98, TA 100, and WP2 uvrA) or thrice (strains TA 1535 and TA 1537) the colony count of the corresponding solvent control is observed.
A dose dependent increase is considered biologically relevant if the threshold is exceeded at more than one concentration.
An increase exceeding the threshold at only one concentration is judged as biologically relevant if reproduced in an independent second experiment.
A dose dependent increase in the number of revertant colonies below the threshold is regarded as an indication of a mutagenic potential if reproduced in an independent second experiment. However, whenever the colony counts remain within the historical range of negative and solvent controls such an increase is not considered biologically relevant.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Experiment 1: 5000 µg/plate (with/without S9), Experiment II: 5000 µg/plate (without S9) or 2500 µg/plate (with S9)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Experiment 1: 5000 µg/plate (without S9) or 1000-5000 µg/plate (with S9), Experiment II: 1000-2500 µg/plate (with S9)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Experiment 1: 5000 µg/plate (without S9) or 1000-5000 µg/plate (with S9), Experiment II: 1000-2500 µg/plate (with S9)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Experiment 1: 333-5000 µg/plate (with S9), Experiment II: 333-2500 µg/plate (with S9)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Experiment 1: 2500-5000 µg/plate (with S9), Experiment II: 1000-2500 µg/plate (with S9)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- No substantial increase in revertant colony numbers of any of the five tester strains was observed following treatment with 2-Bromoacetamido-2´-fluoro-5-chlorobenzophenone at any concentration level, neither in the presence nor absence of metabolic activation (S9 mix). A slight increase in the number of revertant colonies was observed in experiment I in strain WP2 uvrA without S9 mix, but the threshold of twice the colony number of the corresponding solvent control was not reached. Since colony count in the corresponding solvent control as compared to the concentrations is very low, it can be stated that this effect is caused by biological fluctuations at such low numbers and does not indicate a true mutagenic potential.
Applicant's summary and conclusion
- Conclusions:
- 2-Bromoacetamido-2´-fluoro-5-chlorobenzophenone (BFB) is considered to be non-mutagenic in this Salmonella typhimurium and Escherichia coli reverse mutation assay.
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