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EC number: - | 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- March, 4 2021 to April 14, 2021
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 021
- Report date:
- 2021
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- D‐Glucopyranose, oligomeric, C10‐16‐alkyl glycosides, 3‐(3,4‐dicarboxy‐3‐hydroxy‐1‐oxobutoxy)‐2‐hydroxypropyl ethers, sodium salts
- Cas Number:
- 2481100-10-9
- Molecular formula:
- not applicable (UVCB substance)
- IUPAC Name:
- D‐Glucopyranose, oligomeric, C10‐16‐alkyl glycosides, 3‐(3,4‐dicarboxy‐3‐hydroxy‐1‐oxobutoxy)‐2‐hydroxypropyl ethers, sodium salts
- Details on test material:
- - Name of test material (as cited in study report): Suga®Citrate L1C
- Physical state: clear viscous liquid
- Purity: ca. 40% AS
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- To set the dose levels for the main test, the dose-finding test was conducted with test article
treatment doses levels of19.5, 78.1, 313, 1250, and 5000 μglplate.
As a result, there was no increase in the number of revertant colonies, the minimum dose which
showed growth inhibition was selected as the maximum dose for the main test, and the main
test was conducted in the following dose levels. For all strains without metabolic activation, the
maximum dose was set at 78.1 μglplate, and diluted using a common ratio of 2 to prepare a
total of 6 dose levels. For all strains with metabolic activation, the maximum dose was set at
1250 μglplate, and diluted using a common ratio of 2 to prepare a total of 6 dose levels. - Vehicle / solvent:
- Water
Controls
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Water
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- benzo(a)pyrene
- other: see remark
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- The study is regarded as valid because there were no deviations from the test protocols, the study has been performed according to the principles of Good Laboratory Practice, and all validity criteria are fulfilled. Under the test conditions (both with and without metabolic activation) and with the bacterial strains used the test item is considered not to induce a mutagenic effect (induction of gene mutation).
- Executive summary:
In order to examine the gene mutation inducibility of Disodium Laurylglucosides
Hydroxypropyl Citrate, a reverse mutation assay was conducted in Salmonella typhimurium
(hereinafter referred to as S typhimurium) TAlO0, TA1535, TA98 and TA1537, and
Escherichia coli (hereinafter referred to as E coli) WP2 uvr A with or without metabolic
activation by the pre-incubation method. Distilled water was used as the vehicle for the test
article.
To set the dose levels for the main test, the dose-finding test was conducted with test article
treatment doses levels of19.5, 78.1, 313, 1250, and 5000 μglplate.
As a result, there was no increase in the number of revertant colonies, the minimum dose which
showed growth inhibition was selected as the maximum dose for the main test, and the main
test was conducted in the following dose levels. For all strains without metabolic activation, the
maximum dose was set at 78.1 μglplate, and diluted using a common ratio of 2 to prepare a
total of 6 dose levels. For all strains with metabolic activation, the maximum dose was set at
1250 μglplate, and diluted using a common ratio of 2 to prepare a total of 6 dose levels. The
main test was conducted twice at the same dose levels.In conclusion, the result of Disodium Laurylglucosides Hydroxypropyl Citrate was judged to
have no potential to induce gene mutations (negative) under the conditions of this study.
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