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EC number: 620-313-1 | CAS number: 877179-03-8
- 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
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:
- 22 May - 24 Oct 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- adopted in 1997
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Gyemszi, National Institute for Quality- and Organizational Development in Healthcare and Medicines, Budapest, Hungary
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- N-{3',4'-dichloro-5-fluoro-[1,1'-biphenyl]-2-yl}acetamide
- EC Number:
- 620-313-1
- Cas Number:
- 877179-03-8
- Molecular formula:
- C14H10Cl2FNO
- IUPAC Name:
- N-{3',4'-dichloro-5-fluoro-[1,1'-biphenyl]-2-yl}acetamide
Constituent 1
Method
- Target gene:
- his operon (for S. typhimurium strains)
trp operon (for E. coli strain)
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- cofactor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of rats treated with phenobarbital and beta-naphthoflavone
- Test concentrations with justification for top dose:
- Preliminary Range Finding Test (S. typhimurium TA 98 and TA 100 only): 10, 31.6, 100, 316, 2500 and 5000 µg/plate with and without metabolic activation
Initial Mutation Test (all S.typhimurium strains and E.coli strain; plate incorporation method) and Confirmatory Mutation Test (all S.typhimurium strains and E.coli strain; pre-incubation method): 5, 15.81, 158.1, 500, 1581, 5000 µg/plate with and without metabolic activation
Complementary Confirmatory Mutation Test (S. typhimurium strains only; pre-incubation method): 0.1581, 0.5, 1.581, 5, 15.81, 50, 158.1, 500 µg/plate without metabolic activation and 0.5, 1.581, 5, 15.81, 50, 158.1, 500, 1581 µg/plate with metabolic activation
The top dose of the preliminary range finding test, the initial mutation test and the confirmatory mutation test is the recommended maximum test concentration for soluble non-cytotoxic substances according to the OECD guideline 471. The top dose of the complementary confirmatory mutation test in S. typhimurium strains was chosen based on cytotoxic effects observed in the previous tests. - Vehicle / solvent:
- - Vehicle/solvent used: DMSO
- Justification for choice of solvent/vehicle: The solubility of the test item was examined using distilled water, dimethyl sulfoxide (DMSO) and N,N-dimethylformamide (DMF). No proper formulation was achieved using distilled water as vehicle at 100 mg/mL concentration. However the formulations using DMSO or DMF as vehicle at the same concentration were suitable for the test. Due to the better biocompatibility, DMSO was selected as vehicle for the study.
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO and distilled water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- sodium azide
- methylmethanesulfonate
- other: 4-nitro-1,2-phenylene-diamine (NPD): - S9, 4 µg/plate in DMSO for S. typhimurium TA 98 2-aminoanthracene (2AA): +S9, 2 µg/plate in DMSO for S. typhimurium TA 98, TA 100, TA 1535, TA 1537; +S9, 50 µg/plate in DMSO for E.coli WP2 uvrA
- Remarks:
- The S9 batch was characterised with benzo(a)pyrene in addition to 2-aminoanthracene as mutagen that requires metabolic activation.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- other: S. typhimurium TA 98, TA 100, TA 1535 and TA 1537
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 500 µg/plate and above
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- other: S. typhimurium TA 98, TA 100, TA 1535 and TA 1537
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 158.1 µg/plate and above
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Remarks:
- (5000 µg/plate)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- In this mutagenicity test in bacteria, the test substance was not mutagenic in any of the four Salmonella typhimurium strains (TA 1535, TA 1537, TA 98, TA 100) or in Escherichia coli WP2 uvrA tested with and without metabolic activation up to 5000 µg/plate in the plate incorporation test as well as in the pre-incubation test. Using the pre-incubation method a bacteriotoxic effect was noted at 158.1 μg/plate and above in all Salmonella typhimurium without metabolic activation and at 500 µg/plate and above with metabolic activation. Using the plate incorporation method a bacteriotoxic effect was noted at 1581 μg/plate and above in Salmonella typhimurium TA 100 without metabolic activation and at 5000 µg/plate with metabolic activation. In Salmonella typhimurium TA 1535 a bacteriotoxic effect was observed at 5000 µg/plate with and without metabolic activation. No bacteriotoxic effect was noted for the Escherichia coli WP2 uvrA strain; however, precipitation of the test substance was observed at 5000 µg/plate.
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