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EC number: 700-680-5 | 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 bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2008-07-15 to 2008-07-24
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: - Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- adopted July 21, 1997
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- June 8, 2000
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Isostearic acid, esters with methyl α-D-glucoside
- EC Number:
- 700-680-5
- Molecular formula:
- Molecular formula cannot be given as substance is a mixture.
- IUPAC Name:
- Isostearic acid, esters with methyl α-D-glucoside
Constituent 1
Method
- Target gene:
- The Salmonella typhimurium strains used in this study were TA1535, TA1537, TA98 and TA100. The Escherichia coli strain used was WP2 uvrA. The strains TA1537 and TA98 are capable of detecting frameshift mutagens, strains TA1535, TA100 and E. coli wP2 uvrA are capable of detecting base-pair substitution mutagens.
Species / strainopen allclose all
- Species / strain / cell type:
- E. coli WP2 uvr A
- Additional strain / cell type characteristics:
- other: tryphtophane auxotroph
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- other: histidine auxotroph
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-mix induced by combination of phenobarbital (80 mg/kg bw) and ß-naphthoflavone (100 mg/kg bw), rat liver micosomal enzymes prepared in house from adult male Wistar rats, which were obtained from Charles River, Sulzfeld Germany
- Test concentrations with justification for top dose:
- Dose-range finding test:
3, 10, 33, 100, 333, 1000, 3330, 5000 µg/plate
Main test: 33, 100, 333, 1000, 3330 µg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Dimethyl sulfoxide
- Stability of test substance in vehicle: unknown
- Solubility in vehicle: not indicated
Controlsopen allclose all
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene, with S9-mix, further details see "any other information on materials and methods incl. tables"
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- Migrated to IUCLID6: for TA 98, 10 µg, without S9-mix, DMSO as solvent
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- Migrated to IUCLID6: for TA 100, 650 µg, without S9-mix, DMSO as solvent
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- Remarks:
- Migrated to IUCLID6: for WP2uvrA, 10 µg, without S9-mix, DMSO as solvent
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- Migrated to IUCLID6: for TA 1537, 60 µg, without S9-mix, in Milli-Q water as solvent
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- 0.1 ml dimethyl sulfoxide
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- Migrated to IUCLID6: for TA 1535, 5 µg without S9-mix, in physiological saline as solvent
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:in agar (plate incorporation)
DURATION
- Exposure duration: 48 h
SELECTION AGENT (mutation assays): Salmonella typhimurium stains: histidine; E. coli stain: tryptophane
NUMBER OF REPLICATIONS: 3
DETERMINATION OF CYTOTOXICITY
- Method: reduction of the background lawn or reduction of the spontaneous reversion rate
DOSE RANGE FINDING TEST:
- selection of an adequate range of doses was based on a dose range finding test with the strains TA100 and WP2uvrA, both with and without S9-mix.- Eight concentrations, 3, 10, 33, 100, 333, 1000, 3330 and 5000 µg/plate were tested in triplicate.
- The highest concentration of test substance in the subsequent mutation assay was the level at which the test substance exhibited limited solubility.
- Precipitation of test substance on the plates was observed at the start of the incubation period at concentrations of 1000 µg/plate and upwards and at 3330 µg/plate and above at the end of the incubation period.
- Toxicity: to determine the toxicity of the test substance, the reduction of the bacterial background lawn, the increase in the size of the microcolonies and the reduction of the revertant colonies were examined. - Evaluation criteria:
- No formal hypothesis testing was done.
A test substance is considered negative (not mutagenic) in the test if:
a) The total number of revertants in tester strain TA100 is not greater than two (2) times the concurrent control, and the total number of revertants in tester strains TA1535, TA1537, TA98 or WP2uvrA is not greater than three (3) times the concurrent control.
b) The negative response should be reproducible in at least one independently repeated experiment.
A test substance is considered positive (mutagenic) in the test if:
a) The total number of revertants in tester strain TA100 is greater than two (2) times the concurrent control, or the total number of revertants in tester strains TA1535, TA1537, TA98 or WP2uvrA is greater than three (3) times the concurrent control.
b) In case a positive response will be repeated, the positive response should be reproducible in at least one independently repeated experiment.
The preceding crlteria were not absolute and other modifying factors might enter into the final evaluation decision.
Results and discussion
Test resultsopen allclose all
- 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:
- valid
- Positive controls validity:
- valid
- 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:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: was observed at the start of the incubation period at concentrations of 1000 and 3330 µg/plate and at the top dose of 3330 µg/plate at the end of the incubation period.
- Other confounding effects:
RANGE-FINDING/SCREENING STUDIES:
Toxicity: no reduction of the bacterial background lawn and no biologically relevant decrease in the number of revertants were observed.
Mutagenicity: no increase in the number of revertants was observed upon treatment with test substance under all conditions tested.
COMPARISON WITH HISTORICAL CONTROL DATA:
In this study, the strain-specific positive control values were within the laboratory historical control data ranges indicating that the test conditions were adequate and that the metabolic activation system functioned properly.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
There was no reduction of the bacterial background lawn and no biologically relevant decrease in the number of revertants at any of the concentrations tested in all tester strains in the absence and presence of S9-mix. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
Based on the results of this study it is concluded that Isostearic acid, esters with methyl α-D-glucoside is not mutagenic in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay. - Executive summary:
In a reverse gene mutation assay in bacteria according to OECD guideline 471, strains of S. typhimurium (TA 1535, TA 1537, TA 98 and TA 100) and E. coli (WP2 uvr A) were exposed to Isostearic acid, esters with methyl α-D-glucoside, at concentrations of 33, 100, 333, 1000, and 3330 µg/plate in the presence and absence of mammalian metabolic activation (plate incorporation method). Isostearic acid, esters with methyl α-D-glucoside did not induce a significant dose-related increase in the number of revertant colonies in each of the five tester strains, both in the absence and presence of mammalian metabolic activation. These results were confirmed in an independently repeated experiment. No cytotoxic effects of the test substance were observed. Precipitation was observed at concentrations of 1000 and 3330 µg/plate. The positive controls induced the appropriate responses in the corresponding strains and metabolic activation was confirmed. There was no evidence of induced mutant colonies over background. Based on the results of this study it is concluded that Isostearic acid, esters with methyl α-D-glucoside is not mutagenic in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay.
This study is classified as acceptable. It satisfies the requirement for Test Guideline OECD 471 for in vitro mutagenicity (bacterial reverse gene mutation) data.
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