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EC number: 241-158-2 | CAS number: 17091-31-5
- 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:
- 01/2008 to 05/2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
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:
- Bromo(hexahydro-2H-azepin-2-onato-N)magnesium
- EC Number:
- 241-158-2
- EC Name:
- Bromo(hexahydro-2H-azepin-2-onato-N)magnesium
- Cas Number:
- 17091-31-5
- Molecular formula:
- C6H10BrMgNO
- IUPAC Name:
- magnesium(2+) ion 2-oxoazepan-1-ide bromide
- Reference substance name:
- ε-caprolactam
- EC Number:
- 203-313-2
- EC Name:
- ε-caprolactam
- Cas Number:
- 105-60-2
- Molecular formula:
- C6H11NO
- IUPAC Name:
- azepan-2-one
- Test material form:
- solid: particulate/powder
Constituent 1
additive 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 07072601
- Expiration date of the lot/batch: 26.07.2008
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature 20 ± 5 °C
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: no
Method
Species / strain
- Species / strain / cell type:
- other: TA 97a, TA 98, TA 100, TA 102 and TA 1535
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9
- Test concentrations with justification for top dose:
- 4986 to 50 μg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: water
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- benzo(a)pyrene
- other: 4-Nitro-1,2-phenylene diamine (NPD) in DMSO, 2-Amino anthracene (2-AA) in DMSO
- Details on test system and experimental conditions:
- Plate incorporation method
Per strain and dose, four plates with and four plates without S9 mix were used. 10 ml of
the test solution of the appropriate concentration were membrane filtrated into sterile vessels.
Top agar basis was melted in a microwave oven, after melting, 10 ml of histidinebiotin-
solution 0.5 mMol per 100 ml basis was added and the bottle was placed in the
water bath at 45 °C.
0.1 ml of the appropriate solution of the test item were given into a sterile tube. After mixing
with 0.1 ml overnight culture of the respective strain and 0.5 ml phosphate buffer
(only for treatments without S9) or 0.5 ml S9 mix, 2 ml Top-Agar were added. The mixture
was gently vortexed, then poured on a minimal glucose plate and distributed evenly,
using a Drigalski spatula. The plates were closed, covered with brown paper and left to
harden for a few minutes, then inverted and placed in the dark incubator at 37 °C.
Pre-incubation method
Per strain and dose, four plates with and four plates without S9 mix were used. 10 ml of
the test solution of the appropriate concentration were membrane filtrated into sterile vessels.
Top agar basis was melted in a microwave oven, after melting, 10 ml of histidinebiotin-
solution 0.5 mMol per 100 ml basis was added and the bottle was placed in the
water bath at 45 °C.
0.1 ml of the appropriate solution of the test item were given into a sterile tube. After mixing
with 0.1 ml overnight culture of the respective strain, 0.5 ml phosphate buffer (only
for treatments without S9) or 0.5 ml S9 mix were added. The mixture was incubated in an
incubation chamber at 37°C for 20 minutes. During this time the vessels were aerated
through careful shaking. Then 2 ml top agar were added. The mixture was vortexed gently,
then poured on a minimal glucose plate and distributed evenly, using a Drigalski spatula.
The plates were closed, covered with brown paper and left to harden for a few minutes,
then inverted and placed in the dark incubator at 37 °C. - Evaluation criteria:
- The colonies were counted visually, the numbers were recorded.
- Statistics:
- A spreadsheet software (Microsoft Excel®) was used to calculate mean values and standard deviations as well as the increase factor of revertant induction.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 97
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of the test, the test item didn't show mutagenic effects towards Salmonella typhimurium, strains TA 97a, TA 98, TA 100, TA 102 and TA 1535. Therefore, no concentration-effect relationship could be determined.
- Executive summary:
The test item Bromo(hexahydro-2H-azepin-2-onato-N)magnesium is considered as "not mutagenic under the conditions of the test".
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