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EC number: 946-155-6 | 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:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- GLP compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
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:
- BASF SE, Experimental Toxicology and Ecology, 67056 Ludwigshafen, Germany
- Type of assay:
- other: mammalian cell gene mutation assay
Test material
- Reference substance name:
- 1,4:3,6-dianhydro-D-glucitol monooleate
- EC Number:
- 249-031-3
- EC Name:
- 1,4:3,6-dianhydro-D-glucitol monooleate
- Cas Number:
- 28454-96-8
- Molecular formula:
- C24H42O5
- IUPAC Name:
- 1,4:3,6-dianhydro-2-O-oleoyl-D-glucitol
Constituent 1
Method
- Target gene:
- HPRT (hypoxanthine-guanine phosphoribosyl transferase)
Species / strain
- Species / strain / cell type:
- Chinese hamster Ovary (CHO)
- Details on mammalian cell type (if applicable):
- During the week prior to treatment, any spontaneous HPRT-deficient mutants were eliminated by pretreatment with "HAT" medium. 3 – 5E05 cells were seeded per flask (75 cm²) and incubated with "HAT" medium for 3 - 4 days. A subsequent passage in Ham's F12 medium incl. 10 % (v/v) FCS was incubated for a further 3 - 4 days.
- Metabolic activation:
- with and without
- Metabolic activation system:
- phenobarbital/ß-naphthoflavone induced rat liver S9 mix
- Test concentrations with justification for top dose:
- - 1st Experiment, without S9 mix: 3.1, 6.3, 12.5, 25, 50, 100 µg/mL
- 1st Experiment, with S9 mix: 1.6, 3.1, 6.3, 12.5, 25, 50 µg/mL
- 2nd Experiment, without S9 mix: 4.4, 8.8, 17.5, 35, 70, 100 µg/mL
- 2nd Experiment, with S9 mix: 2.2, 4.4, 8.8, 17.5, 35, 70 µg/mL - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: Due to the insolubility of the test substance in water, dimethyl sulfoxide (DMSO) was selected as vehicle, which had been demonstrated to be suitable in the CHO/HPRT assay and for which historical data are available.
- The final concentration of the vehicle DMSO in the culture medium was 1 % (v/v).
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 7,12-dimethylbenzanthracene
- ethylmethanesulphonate
- Remarks:
- ethylmethanesulphonate (without metabolic activation), 7,12-dimethylbenzanthracene (with metabolic activation)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Pre-incubation period: 20 - 24 hours
- Exposure duration: 4 hours
- Expression time (cells in growth medium): 7 - 9 days
- Selection time: 6 - 7 days
SELECTION AGENT: 6-thioguanine
DETERMINATION OF CYTOTOXICITY
- Method: cloning efficiency - Evaluation criteria:
- The HPRT assay is considered valid if the following criteria are met:
- The absolute cloning efficiencies of the negative/vehicle controls should not be less than 50 % (with and without S9 mix).
- The background mutant frequency in the negative/vehicle controls should be within the historical negative control data range of 0.00 – 16.43 mutants per 1E6 clonable cells.
- The positive controls both with and without S9 mix have to induce distinctly increased mutant frequencies (historical positive control data).
- At least 4 dose levels should be tested ranging up to a toxic concentration or up to or beyond the limit of solubility under culture conditions. Freely soluble and apparently non-toxic substances are not tested at concentrations higher than 5 mg/mL or 10 mM.
A finding is assessed as positive if the following criteria are met:
- Increase in the corrected mutation frequencies (MFcorr.) both above the concurrent negative control values and the historical negative control data range.
- Evidence of the reproducibility of any increase in mutant frequencies.
- A statistically significant increase in mutant frequencies and the evidence of a dose-response relationship.
Isolated increases of mutant frequencies above the historical negative control range (i.e. 15 mutants per 1E6 clonable cells) or isolated statistically significant increases without a dose-response relationship may indicate a biological effect but are not regarded as sufficient evidence of mutagenicity.
The test substance is considered non-mutagenic according to the following criteria:
- The corrected mutation frequency (MFcorr.) in the dose groups is not statistically significantly increased above the concurrent negative control and is within the historical negative control data range. - Statistics:
- An appropriate statistical trend test (MS EXCEL function RGP) was performed to assess a dose-related increase of mutant frequencies. The number of mutant colonies obtained for the test substance treated groups was compared with that of the respective vehicle control groups. A trend is judged as statistically significant whenever the one-sided p-value (probability value) is below 0.05 and the slope is greater than 0. However, both, biological and statistical significance will be considered together.
Results and discussion
Test results
- Key result
- Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- MUTANT FREQUENCY
In this study, no increase in the number of mutant colonies was observed with or without S9 mix. In both experiments after 4 hours treatment with the test substance the values for the corrected mutation frequencies (MFcorr.: 0.00 – 4.44 per 1E6 cells) were close to the respective vehicle control values (MFcorr.: 0.31 – 5.25 per 1E6 cells) and clearly within the range of our historical negative control data (without S9 mix: MFcorr.: 0.00 – 16.43 per 1E6 cells; with S9 mix:
MFcorr.: 0.00 – 16.12 per 1E6 cells). No statistical significance was observed. The positive control substances EMS and DMBA induced a clear increase in mutation frequencies, as expected. The values of the corrected mutant frequencies (without S9 mix: MFcorr.: 114.35 – 143.52 per 1E6 cells; with S9 mix: MFcorr.: 272.13 – 287.68 per 1E6 cells) were clearly within the historical positive control data range (without S9 mix: MFcorr.: 47.35 – 383.57 per 1E6 cells; with S9 mix: MFcorr.: 41.99 – 812.14 per 1E6 cells).
TEST-SPECIFIC CONFOUNDING FACTORS
- Osmolality and pH values were not influenced by test substance treatment.
- Precipitation: In this study, in the absence of S9 mix, test substance precipitation was observed in culture medium at the end of treatment at 100.0 μg/mL in the 1st and 2nd Experiment, respectively. In the presence of S9 mix precipitation was observed at 50.0 μg/mL in the 1st Experiment and at 70.0 μg/mL in the 2nd Experiment.
RANGE-FINDING/SCREENING STUDIES:
In the pre-test for toxicity based on the purity of the test substance 5500 μg/mL was used as top concentration both with and without S9 mix at 4-hour exposure time. The pre-test was performed following the method described for the main experiment. The cloning efficiency (survival) was determined as a toxicity indicator for dose selection and various parameters were checked for all, or at least some, selected doses. In the pre-test the pH value was not relevantly influenced by the addition of the test substance preparation to the culture medium at the concentrations measured. In addition, precipitation of the test substance in the vehicle DMSO was not observed up to the highest required concentration of 5500 μg/mL. In culture medium, test substance precipitation occurred by the end of treatment at concentrations of 171.9 μg/mL and above in the absence and presence of S9 mix. After 4 hours treatment in the absence of S9 mix cytotoxicity was observed as indicated by a reduced relative cloning efficiency of about or below 20 % after treatment with 85.9 μg/mL and above. In addition, in the presence of S9 mix, a clearly reduced relative cloning efficiency was observed after treatment with 43.0 μg/mL and above.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
Cytotoxic effects, as indicated by clearly reduced cloning efficiencies of about or below 20 % of the respective negative control values were observed in both experiments in the presence and absence of S9 mix, at least at the highest applied concentrations. Without S9 mix, there was a decrease in the number of colonies from about 100.0 μg/mL after an exposure period of 4 hours in the 1st Experiment and from about 70.0 μg/mL onward in the 2nd Experiment. The cell densities were distinctly reduced. In addition, with S9 mix, there was a decrease in the number of colonies at 50 μg/mL in the 1st Experiment and from about 35.0 μg/mL onward in the 2nd Experiment. The cell densities were not distinctly reduced. After 4 hours of treatment the morphology and attachment of the cells treated with the highest applied concentrations was adversely influenced (grade > 2) in all experimental parts scored for gene mutations. This occurred in samples regardless of the presence of metabolic activation. - Remarks on result:
- other: all strains/cell types tested
Any other information on results incl. tables
The test is assessed as negative.
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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