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EC number: 400-390-6 | CAS number: 87787-67-5 FLEXSORB-SE
- 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 mammalian cells
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 19 May 88 to 06 June 88
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in accordance with generally accepted scientific principles, possibly with incomplete reporting or methodological deficiencies, which do not affect the quality of the relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Deviations:
- not specified
- GLP compliance:
- not specified
- Type of assay:
- mammalian cell gene mutation assay
Test material
- Reference substance name:
- 7,7-dimethyl-3-oxa-6-azaoctan-1-ol
- EC Number:
- 400-390-6
- EC Name:
- 7,7-dimethyl-3-oxa-6-azaoctan-1-ol
- Cas Number:
- 87787-67-5
- Molecular formula:
- Hill formula: C8 H19 N O2 CAS formula: C8 H19 N O2
- IUPAC Name:
- 2-[2-(tert-butylamino)ethoxy]ethan-1-ol
- Details on test material:
- - Name of test material (as cited in study report): MRD-88-192
- Physical state: Clear, colourless liquid
- Analytical purity: 100%
- Storage condition of test material: Room temperature
Constituent 1
Method
- Target gene:
- Thymidine kinase (TK +/-)
Species / strain
- Species / strain / cell type:
- mouse lymphoma L5178Y cells
- Details on mammalian cell type (if applicable):
- Culture preparation: L5178Y TK +/- Mouse Lymphoma Cells were treated with methotrexate, thymidine, glycine and hypoxanthine prior to freezing to eliminate possible spontaneous TK -/- mutants. As needed, cells were then removed from liquid nitrogen storage, cultured and maintained in logarithmic phase for five days before use in the assay system.
Culture medium - F10p
Cloning medium - F20p - Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor induced rat liver (S9 mix)
- Test concentrations with justification for top dose:
- Toxicity assay: Doses ranged from 1 to 1000 μg/ml.
Mutagenesis assay: Based on the results of the toxicity assay, six doses were used in the mutagenesis assay; 500, 700, 900, 1100, 1300 and 1500 μg/ml, but only five doses were plated. Because all doses had greater than 10% relative suspension growth, the lowest dose was eliminated; and 700, 900, 1100, 1300 and 1500 μg/ml were treated with and without activation. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Dimethylsulfoxide (DMSO)
- Justification for choice of solvent/vehicle:Considered under the conditions of the assay to be stable for the duration of the assay.
The test material and positive controls were diluted and dosed prior to administration.
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 7,12-dimethylbenzanthracene
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- ethylmethanesulphonate
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Exposure duration: 3 hour and 20 minute exposure
- Expression time (cells in growth medium): 2-day expression period
SELECTION AGENT (mutation assays): TFT = Trifluorothymidine Deoxyriboside
NUMBER OF REPLICATIONS: 3 plates per dose group.
NUMBER OF CELLS EVALUATED:
Approximately 9XE5 cells were plated in 30ml F20p with 2.5 μg/ml TFT. Concurrently, approximately 180 cells were plated in 30 ml F20p without a selective agent, to determine viable colony counts (VC).
DETERMINATION OF CYTOTOXICITY
- Method: Relative suspension growths, relative cloning growths, relative total growths, mutant frequencies amd induced mutant frequencies were calculated.
Plates were labelled with study number, compound identification number, the dose administered, VC or TFT, +S9 or -S9. Colonies were enumerated after eleven days incubation at 36-38 deg C with 4.5-5% CO2. Plate counts were made with a Biotran III colony counter and recorded.
- Evaluation criteria:
- A test material is considered positive if it yields a 2-fold increase over the spontaneous mutant frequency of vehicle controls at one or more dose levels, if a dose related increase in response is observed and if the relative total growth is greater than 10%. Should the relative total growth, (survival) be less than 10% and a two-fold increase in mutant frequency observed, the test material will be considered negative.
- Statistics:
- The following equations were used in the data analysis of the forward mutation assay:
Relative Suspension Growth, % =
Total suspension growth of test culture / mean total suspension growth of vehicle controls x 100%
Relative cloning growth, % =
Mean number of VC Colonies on “X” treated plates / Average of mean of VC colonies on vehicle control plates x 100%
Relative total growth, % =
(Relative suspension growth, %) (Relative cloning growth, %) / 100%
Mutant Frequency (mutants / 10E4) =
Mean number of TFT colonies for “X” / Mean number of VC colonies for “X” x 2
Induced Mutant Frequency (IMF) = Mutant frequency of treated cultures - mean mutant frequency of vehicle control cultures
VC = Viable colonies
"X" = Dose being evaluated
Results and discussion
Test results
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Dose selection for the repeat mutation assay* was based on a toxicity (dose determination) assay. The doses selected were 700, 900, 1100, 1300 and 1500 μg/ml. These were tested with and without metabolic activation.
*The initial mutation assay was repeated because plate count values were out of range.
Please see attached background material for Table 1 - Summary of mouse lymphoma mutagenicity data, and Table 2 - Mouse growth results with and without metabloic activation.
A mutant frequency greater than 2(X) the mean control mutant frequency was not observed at any dose. The positive (DMBA and EMS) and negative (Controls 1 and 2, + and - S9) controls responded in a manner consistant with data from previos analysis. - Remarks on result:
- other: strain/cell type: L5178Y cells
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
A mutant frequency that was greater than two times the mean vehicle control frequency was not observed at any dose level, nor was there any evidence of a dose related response.
For this reason, it can be concluded that, under the conditions of this assay, the test substance does not induce gene mutations in L5178Y mouse lymphoma cells. - Executive summary:
The mutagenic activity of the test substance was tested in the L5178Y mouse lymphoma assay. The positive controls were dimethylbenzanthracene (DMBA) and ethylmethanesulphonate (EMS). The substance was tested at 700, 900, 1100, 1300, 1500 μg/ml
with and without metabolic activation. Following a three hour and 20 minute exposure period, test and control cultures were allowed a two day expression period. Cultures were cloned in selective medium, then incubated for eleven days. Surviving and mutant colonies were then counted and the mutant frequencies calculated.
There was no evidence of a dose related increase in mutagenic frequency, and the mutant frequencies were not significantly different from control at any dose. For this reason, it can be concluded that, under the conditions of this assay, the test substance does not induce gene mutations in L5178Y mouse lymphoma cells.
The positive (DMBA, EMS) and negative (DMSO) controls responded in a manner consistant with data from previous studies.
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