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EC number: 940-417-3 | CAS number: -
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 2011-08-10 to 2011-12-23
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Scientifically well performed study; Guideline study; GLP study Rational: the components of the registration substance and the read-across supporting substance form "chain length category", whereby the number of unit CH2CH2O varies in the center of the moluecule; n = 2 for the read-across supporting substance and n = 3, 4 for the components of the registration substance
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.17 (Mutagenicity - In Vitro Mammalian Cell Gene Mutation Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5300 - In vitro Mammalian Cell Gene Mutation Test
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- (Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit, Germany)
- Type of assay:
- mammalian cell gene mutation assay
Test material
- Reference substance name:
- Bis(2-butoxyethyl) ether
- EC Number:
- 204-001-9
- EC Name:
- Bis(2-butoxyethyl) ether
- Cas Number:
- 112-73-2
- Molecular formula:
- C12H26O3
- IUPAC Name:
- 1,1'-[oxybis(ethane-2,1-diyloxy)]dibutane
- Reference substance name:
- DEGDBE
- IUPAC Name:
- DEGDBE
- Details on test material:
- Name: Diethyleneglycoldibutylether
CAS No.: 112-73-2
Chemical Name: Bis(2-butoxyethyl)ether
Molecular Weight: 218.33
Active Components: 100%
Physical State: liquid
pH: 6.5-7.5 (25°C, 100 g/L i-propanol/water 4:1)
Colour: colourless
Storage Conditions: at room temperature
Constituent 1
Constituent 2
Method
- Target gene:
- hypoxanthine-guanine-phosphoribosyl-transferase (HPRT)
Species / strain
- Species / strain / cell type:
- Chinese hamster lung fibroblasts (V79)
- Details on mammalian cell type (if applicable):
- -Type and identity of media: MEM
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: yes
- Periodically "cleansed" against high spontaneous background: yes
- Metabolic activation:
- with and without
- Metabolic activation system:
- Liver S9 of Wistar Phenobarbital and ß-Naphthoflavone-induced rat liver S9 mix
- Test concentrations with justification for top dose:
- Pre-experiment for experiment I (with and without metabolic activation):
3.0, 4.0, 5.0, 6.0, 6.5, 7.0, 7.5, 8.0, 9.0, 10.0 mM
Pre-experiment for experiment II (only without metabolic activation, 20 h long-term exposure assay):
0.1, 0.2, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0 mM
Experiment I
without metabolic activation:
0.05, 0.1, 0.25, 0.5, 1.0, 2.0, 3.0 and 3.5 mM
and with metabolic activation:
0.5, 1.0, 2.0, 2.25, 2.5, 2.75, 3.0 and 3.5 mM
Experiment II
without metabolic activation:
0.2, 0.5, 1.0, 2.0, 2.15, 2.30, 2.45 and 2.6 mM
and with metabolic activation:
0.03, 0.07, 0.15, 0.3, 0.7, 1.4, 1.8, 2.1 and 2.4 mM - Vehicle / solvent:
- Vehicle (Solvent) used: cell culture medium (MEM + 0% FBS 4h treatment; MEM + 10% FBS 20h treatment).
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- no
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: without metabolic activation: Ethylmethanesulfonate (300µg/mL), with metabolic activation: 7,12-Dimethylbenz(a)anthracene (1 and 1.5 µg/mL)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: dissolved in medium
DURATION: 4 h (short-term exposure), 20 h (long-term exposure)
Expression time (cells in growth medium): 48-72 h
Selection time (if incubation with selection agent): about one week
SELECTION AGENT ( mutation assay) 11 µg/mL 6-thioguanine (TG)
NUMBER OF REPLICATIONS: two separate experiments (I+II) with single exposure; 5 individual flasks were seeded and evaluated
NUMBER OF CELLS EVALUATED: 400000 cells per flask
DETERMINATION OF CYTOTOXICITY: Method: relative growth; cloning efficiency - Evaluation criteria:
- A test is considered to be negative if there is no biologically relevant increase in the number of mutants.
There are several criteria for determining a positive result:
-a reproducible three times higher mutation frequency than the solvent control for at least one of the concentrations;
-a concentration related increase of the mutation frequency; such an evaluation may be considered also in the case that a three-fold increase of
the mutant frequency is not observed;
-if there is by chance a low spontaneous mutation rate in the corresponding negative and solvent controls a concentration related increase of the mutations within their range has to be discussed.
Results and discussion
Test results
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- yes (Experiment I without S9: ≥ 3.0 mM; experiment I with S9: ≥ 2.75 mM; Experiment II without S9: ≥ 2.00 mM; Experiment II with S9:≥ 2.10 mM
- Untreated negative controls validity:
- valid
- 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
In a mammalian cell gene mutation assay (HPRT locus),V79 cells cultured in vitro were exposed to diethylene glycol dibutyl ether (DEGDBE) dissolved in MEM (+ 0% FBS (4h treatment) + 10% FBS (20h treatment)) at concentrations of
- 0.05, 0.1, 0.25, 0.5, 1.0, 2.0, 3.0 and 3.5 mM (without metabolic activation, Experiment I)
- 0.5, 1.0, 2.0, 2.25, 2.5, 2.75, 3.0 and 3.5 mM (with metabolic activation, Experiment I)
- 0.2, 0.5, 1.0, 2.0, 2.15, 2.30, 2.45 and 2.6 mM (without metabolic activation, Experiment II)
- 0.03, 0.07, 0.15, 0.3, 0.7, 1.4, 1.8, 2.1 and 2.4 mM (with metabolic activation, Experiment II).
DEGDBE was tested up to cytotoxic concentrations.
Biologically relevant growth inhibition was observed in experiment I and II with and without metabolic activation. In experiment I the highest biologically relevant concentration evaluated without and with metabolic activation was 3.5 mM with a relative growth of 16.5% (without metabolic activation) and 9.0% (with metabolic activation).In experiment II without metabolic activation the relative growth was 12.2% for the highest concentration (2.6 mM) evaluated. The highest concentrations evaluated with metabolic activation were 2.1 and 2.4 mM with a relative growth of 42.8% and 6.7%, respectively.
In experiment I without metabolic activation the highest mutation rate (compared to the negative control values) of 2.62 was found at a concentration of 0.05 mM with a relative growth of 101.2%.
In
experiment I with metabolic activation the highest mutation rate
(compared to the negative control values) of 1.52 was found at a
concentration of 3.0 mM with a relative growth of 45.7%.
In experiment II without metabolic activation the highest mutation rate
(compared to the negative controls values) of 1.30 was found at a
concentration of 2.15 mM with a relative growth of 52.7%.
In experiment II with metabolic activation the highest mutation rate
(compared to the negative controls values) of 2.95 was found at a
concentration of 2.4 mM with a relative growth of 6.7%. At this
concentration an increased number of mutant colonies (70.12 mutants per
106cells) was observed, exceeding the historical data range. Due to the
fact that this concentration was accompanied with a strong cytotoxic
effect, the observed increased number of mutants/106cells is considered
to be not biologically relevant..
The positive controls did induce the appropriate response.
There was no evidence of a concentration related positive response of induced mutant colonies over background.
This study is classified as acceptable. This study satisfies the requirement for Test Guideline OPPTS 870.5300, OECD 476 forin vitromutagenicity (mammalian forward gene mutation) dataApplicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
The mutagenicity property of the registration substance is derived based on the read-across from diethyleneglycoldibutylether (DEGDBE). DEGDBE was investigated for its mutagenicity in bacteria according to the OECD Guideline 471 (Ames test). DEGDBE was not mutagenic with and without metabolic activation in two independent experiments. No mutagenicitiy could be concluded for DEGDBE. Likewise no mutagenicity in bacteria can be derived for the registration substance. - Executive summary:
The mutagenicity property of the registration substance is derived based on the read-across from diethyleneglycoldibutylether (DEGDBE). DEGDBE was investigated for its mutagenicity potential in HPRT. DEGDBE was not mutagenic with and without metabolic activation in two independent experiments. No mutagenicitiy could be concluded for DEGDBE. Likewise no mutagenicity in mammalian cells can be derived for the registration substance.
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