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EC number: 700-772-5 | CAS number: 1190961-28-4
- 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
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- between February 3, 2011 and February 28, 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted to GLP in accordance with recognised guideline
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 1,6-bis({2,2-bis[(undecyloxy)methyl]butyl}) hexanedioate
- EC Number:
- 700-772-5
- Cas Number:
- 1190961-28-4
- Molecular formula:
- N/A - too complex
- IUPAC Name:
- 1,6-bis({2,2-bis[(undecyloxy)methyl]butyl}) hexanedioate
- Test material form:
- other: liquid
- Details on test material:
- - Physical state: Clear straw liquid
- Analytical purity: > 99%
- Lot/batch No.: 1460-009-08-135-2
- Storage condition of test material: room temperature
Constituent 1
Method
- Target gene:
- Not required
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Details on mammalian cell type (if applicable):
- Non-mammalian study
- Species / strain / cell type:
- E. coli WP2 uvr A
- Details on mammalian cell type (if applicable):
- Non-mammalian study
- Metabolic activation:
- with and without
- Metabolic activation system:
- phenobarbital (PB, 4 times 0.03-0.06g/kg/day) and 5,6-benzoflavone (BF, I time 0.08g/kg/day) induced rat liver S9
- Test concentrations with justification for top dose:
- Experiment 1: Range-finding test
Salmonella strains: 4.88, 19.5, 78.1, 313, 1250, and 5000 µg/plate
Experiment 2: Main test
All Salmonella strains (with and without S9) except TA100 (without 156: 313, 625. 1250 150, 500, 1500, 5000 μg/plate.
Salmonella 00 (without S9): 5, 15, 50, 150, 500, 1500, 5000 μg/plate.
E.coli strain WP2uvrA- : 50, 150, 500, 1500, 5000 μg/plate. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: acetone
- Justification for choice of solvent/vehicle: The test material was insoluble in sterile distilled water, suspended in dimethyl sulphoxide at 50 mg/ml but was fully miscible in acetone at the same concentration in solubility checks performed in-house. Acetone was therefore selected as the vehicle.
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Concurrent
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- Concurrent
- Positive control substance:
- other: 2-(2-Furyl)-3-(5-nitro-2-furyl)acrylamide
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Concurrent
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- Concurrent
- Positive control substance:
- 9-aminoacridine
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Concurrent
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- Concurrent
- Positive control substance:
- sodium azide
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: pre-incubation method at multiple dose levels, in duplicate, both with and without the addition of a rat liver homogenate metabolising system (10% liver S9 in standard co-factors).
The assay was performed by mixing 0.1 ml of bacterial culture, 0.05 ml of the substance formulation, 0.5 ml of S9-mix or phosphate buffer and 2 ml of molten, trace histidine or tryptophan supplemented, top agar and overlaying onto sterile plates of Vogel-Bonner Minimal agar. In total six concentrations of the test material and a vehicle control (acetone) were tested. After approximately 48 hours incubation at 37°C the plates were assessed for numbers of revertant colonies and examined for effects on the growth of the bacterial background lawn.
DURATION
- Preincubation period: 20 min
- Exposure duration: Approximately 48 hours
- Expression time (cells in growth medium): N/A
- Selection time (if incubation with a selection agent): N/A
- Fixation time (start of exposure up to fixation or harvest of cells): N/A
SELECTION AGENT (mutation assays): NDA
SPINDLE INHIBITOR (cytogenetic assays): N/A
STAIN (for cytogenetic assays): N/A
NUMBER OF REPLICATIONS: 2 replicates of each strain at each concentration both in the presence and absence of S9
- Evaluation criteria:
- The test material may be considered positive in this test system if the following criteria are met:
The test material should have induced a reproducible and dose-related increase in the revertant count in at least one strain of bacteria. - Statistics:
- NDA
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Cytotoxicity to bacteria by the test material was not observed for TA98, TA100, TA1535, TA1537 and WP2uvrA at any dose level with or without metabolic activation in the dose-determination test and the mutagenicity test.
Precipitate of the test material was observed at 5000ug/plate for TA98, TA100, TA1535, TA1537 and WP2uvrA with metabolic activation in the dose-determination test and the mutagenicity test.
No significant increases in the frequency of revertant colonies were recorded for any of the bacterial strains at any dose level, either with or without metabolic activation. The test material was considered to be non-mutagenic under the conditions of this test.
All of the positive control chemicals used in the test induced marked increases in the frequency of revertant colonies thus confirming the activity of the S9 mix and the sensitivity of the bacterial strains.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
The substance was considered to be non-mutagenic under the conditions of this test. - Executive summary:
Method
This study was designed to assess the mutagenic potential of the test substance using a bacterial/ microsome test system.
Salmonella typhimurium strains TA98, TA100, TA1535, TAI537 and Escherichia coli WP2uvrA were treated with the test material using the pre-incubation method at six dose levels, in duplicate, both with and without the addition of a rat liver homogenate metabolizing system (10% liver S9 in standard co-factors). The dose range for the dose-determination test was 4.88 to 5000 ug/plate. The experiment as repeated on a separate day using the dose range, 156 to 5000 ug/plate, fresh cultures of the bacterial strains and fresh test material formulations.
Results
Cytotoxicity to bacteria by the test material was not observed for TA98, TA100, TA1535, TA1537 and WP2uvrA at any dose level with or without metabolic activation.
Precipitate of the test material was observed at 5000 ug/plate for TA98, TA100, TA1535, TA1537 and WP2uvrA with metabolic activation.
No significant increases in the frequency of revertant colonies were recorded for any of the bacterial strains, at any dose level either with or without metabolic activation.
Conclusion
The test material was considered to be non-mutagenic under the conditions of this test.
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