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EC number: 908-300-1 | 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1988
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 988
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- GLP compliance:
- not specified
- Type of assay:
- in vitro mammalian cell gene mutation tests using the thymidine kinase gene
Test material
- Reference substance name:
- short chain Fructo-Oligosaccharides
- EC Number:
- 908-300-1
- Molecular formula:
- C6H11O5(C6H10O5)nOH
- IUPAC Name:
- short chain Fructo-Oligosaccharides
- Details on test material:
- Neosugar is a mixture of fructooligosaccharides such as 1-kestose (GF2), nystose (GF3) and 1F-1-fructofuranosyl nystose (GF4). The sugar composition of Neosugar is approximately 37% GF2, 21% GF3 and 12% GF4.
Constituent 1
- Specific details on test material used for the study:
- Neosugar is a mixture of fructooligosaccharides such as 1-kestose (GF2), nystose (GF3) and 1F-1-fructofuranosyl nystose (GF4). The sugar composition of Neosugar is approximately 37% GF2, 21% GF3 and 12% GF4.
Neosugar provided by Meiji Seika Kaisha Ltd.
Method
Species / strain
- Species / strain / cell type:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor-induced rat liver microsomal metabolic activation system.
Metabolic activation system used consisting of liver microsomal fraction (S-9) from Charles River CD rats, 6-8 weeks old, given a single intraperitoneal injection of Aroclor 1254 at 500 mg/kg body weight 5 days before killing. The livers were removed and homogenized in three times their weight of ice-cold 0.15 MKCI. The homogenate was centrifuged at 900 g for 10 min, and the supernatant (S-9 fraction) was collected and stored at -70°C. The S-9 fraction was mixed with appropriate cofactors immediately before use.
In all cases, the functioning of the S-9 mix was tested by including positive control materials that required metabolic activation to express a genotoxic effect.
For the mouse lymphoma assay, the S-9 fraction was added to a threefold larger volume of icecold RPMI 1640 medium containing isocitric acid at 15 mg/ml and NADP at 8 mg/ml immediately before use, and 8 ml of that mixture was added to 12 ml of cell suspension with 0.2 ml of test solution. - Test concentrations with justification for top dose:
- Mutagenicity was tested by treating populations of 12 x 10E6 cells for 3 hr at 37°C with neosugar at 2000, 3000,4000, and 5000 µg/ml.
Controls
- Untreated negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- ethylmethanesulphonate
- Details on test system and experimental conditions:
- Preliminary toxicity tests:
Preliminary toxicity tests were conducted by treating cells in suspension with neosugar at 50, 100, 250, 1000, 2500, and 5000 pg/ml at 37°C for 3 hr. The highest dose used represented the maximum dose used routinely in this assay to avoid confounding physical effects. The cells were then washed and resuspended in normal growth medium and cultured at 37°C. Cell population growth was monitored at 24 and 48 hr using a Coulter counter.
Defintive toxiciy tests:
Mutagenicity was tested by treating populations of 12 x 10E6 cells for 3 hr at 37°C with neosugar at 2000, 3000, 4000, and 5000 pg/ml in the presence and absence of an Aroclor-induced rat liver microsomal
metabolic activation system. After treatment in serum-free medium, the cells were washed and grown for 48 hr in normal growth medium to allow expression of any induced mutations, then cloned in soft agar to test for viability (600 cells/plate) and mutations (lo6 cells/plate, plus trifluorothymidine at 4 pg/ml). The procedures used are based on those of Clive and Spectorl and Amacher et al.
Two independent trials were conducted both in the presence and in the absence of metabolic activation.
Results and discussion
Test results
- Key result
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- In both trials, no significant toxicity at any dose level was detected, as measured by cell population growth after treatment or colony-forming ability Also, no increase in mutation frequency was seen in either trial, either with or without metabolic activation.
The positive control chemicals produced the expected clear increases in mutation frequency.
Applicant's summary and conclusion
- Conclusions:
- No increase in mutation frequency was seen in either trial, either with or without metabolic activation.
No indication of mutagenicity was observed. - Executive summary:
A Mammalian cell mutation assay with mouse lymphoma L5178Y cells was performed. Preliminary toxicity was tested with scFOS concentrations of 50, 100, 250, 1000, 2500, or 5000 μg/ml. Mutagenicity was tested with concentrations of 2000, 3000, 4000, or 5000 μg/ml in the presence and absence of an Arochlor-induced rat liver microsomal metabolic activation system.
No indication of mutagenicity was observed.
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