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EC number: 245-485-1 | CAS number: 23202-81-5
- 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:
- 3 December 2012 to 14 March 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Fully GLP compliant and in accordance with current test guidelines
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Methylfuranoside
- IUPAC Name:
- Methylfuranoside
- Reference substance name:
- Methyl 5-deoxy-2,3-O-isopropylidene-β-D-ribofuranoside
- EC Number:
- 245-485-1
- EC Name:
- Methyl 5-deoxy-2,3-O-isopropylidene-β-D-ribofuranoside
- Cas Number:
- 23202-81-5
- Molecular formula:
- C9H16O4
- IUPAC Name:
- methyl 5-deoxy-2,3-O-isopropylidene-beta-D-ribofuranoside
- Test material form:
- other: Light yellow liquid
- Details on test material:
- Name: Methylfuranoside
CAS number: 23202-81-5
Batch number: 201111082008#
Quantity received: 1.5 kg
Purity: 99.7%
Expiry date: Nov 2013
Date of receipt: 19 Nov 2012
Storage details: stored in a sealed container, at room temperature (15 to 25°C) in the dark
Constituent 1
Constituent 2
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Details on mammalian cell type (if applicable):
- For all assays, bacteria were cultured at 37±1°C for 10 hours in nutrient broth, containing ampicillin (TA98, TA100) or ampicillin and tetracycline (TA102) as appropriate, to provide bacterial cultures in the range of approximately 108 to 109 cells/mL, based on cell count data from testing of each strain batch.
- Metabolic activation:
- with and without
- Metabolic activation system:
- Tha mammalian liver post-mitochondrial fraction S-9 used for metabolic activation was prepared from male Sprague Dawley rats induced with Aroclor 1254.
- Test concentrations with justification for top dose:
- Mutation experiment 1 (with and without S-9)
Concentration of treatment solution: 0.05000 mg/mL, final concentration: 5.000 µg/plate
Concentration of treatment solution: 0.1581 mg/mL, final concentration: 15.81 µg/plate
Concentration of treatment solution: 0.5000 mg/mL, final concentration: 50.00 µg/plate
Concentration of treatment solution: 1.581 mg/mL, final concentration: 158.1 µg/plate
Concentration of treatment solution: 5.000 mg/mL, final concentration: 500.0 µg/plate
Concentration of treatment solution: 15.81 mg/mL, final concentration: 1581 µg/plate
Concentration of treatment solution: 50.00 mg/mL, final concentration: 5000 µg/plate
Mutation experiment 2 (with and without S-9)
Concentration of treatment solution: 1.563 mg/mL, final concentration: 156.3 µg/plate
Concentration of treatment solution: 3.125 mg/mL, final concentration: 312.5 µg/plate
Concentration of treatment solution: 6.250 mg/mL, final concentration: 625.0 µg/plate
Concentration of treatment solution: 12.50 mg/mL, final concentration: 1250 µg/plate
Concentration of treatment solution: 25.00 mg/mL, final concentration: 2500 µg/plate
Concentration of treatment solution: 50.00 mg/mL, final concentration: 5000 µg/plate
Positive controls
2-nitrofluorene (2NF), stock concentration: 50 µg/mL, Final concentration: 5 µg/plate, TA98 without S-9
Sodium azide (NaN3), stock concentration: 20 µg/mL, Final concentration: 2 µg/plate, TA100 and TA1535 without S-9
9-aminoacridine (AAC), stock concentration: 500 µg/mL, Final concentration: 50 µg/plate, TA1537, without S-9
Mitomycin C (MMC), stock concentration: 2 µg/mL, Final concentration: 0.2 µg/plate, TA102, without S-9
Benzo[a]pyrene (B[a]P), stock concentration: 100 µg/mL, Final concentration: 10 µg/plate, TA98, with S-9
2-aminoanthracene (AAN), stock concentration: 50 µg/mL, Final concentration: 5 µg/plate, TA100, TA1535 and TA1537, with S-9
2-aminoanthracene (AAN), stock concentration: 200 µg/mL, Final concentration: 20 µg/palte, TA102, with S-9 - Vehicle / solvent:
- Dimethyl sulfoxide (DMSO)
Controls
- Untreated negative controls:
- yes
- Remarks:
- (DMSO)
- Negative solvent / vehicle controls:
- no
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- benzo(a)pyrene
- mitomycin C
- other: 2-aminoanthracene
- Remarks:
- For concentrations of positive controls see test concentrations section
- Details on test system and experimental conditions:
- Methylfuranoside was tested for mutation (and toxicity) in five strains of Salmonella typhimurium (TA98, TA100, TA1535, TA1537 and TA102), in two separate experiments using triplicate plates without and with S-9. Negative (vehicle) controls were included in quintuplicate, and positive controls were included in triplicate in both assays without and with S-9. These platings were achieved by the following sequence of additions to 2.5 mL molten agar at 46±1°C:
• 0.1 mL bacterial culture
• 0.1 mL test article solution or control
• 0.5 mL 10% S-9 mix or buffer solution
followed by rapid mixing and pouring on to Vogel-Bonner E agar plates. When set, the plates were inverted and incubated at 37±1°C in the dark for 3 days. Following incubation, these plates were examined for evidence of toxicity to the background lawn, and where possible revertant colonies were counted.
As the results of Experiment 1 were negative, treatments in the presence of S-9 in Experiment 2 included a pre-incubation step. Quantities of test article or control solution (reduced to 0.05 mL), bacteria and S-9 mix detailed above, were mixed together and incubated for 20 minutes at 37±1°C, with shaking, before the addition of 2.5 mL molten agar at 46±1°C. Plating of these treatments then proceeded as for the normal plate incorporation procedure. In this way, it was hoped to increase the range of mutagenic chemicals that could be detected in the assay.
Volume additions for the Experiment 2 pre-incubation treatments were reduced to 0.05 mL due to the vehicle (DMSO) employed in this study. This, and some other organic vehicles, are known to be near to toxic levels when added at volumes of 0.1 mL in this assay system when employing the pre-incubation methodology. By reducing the addition volume to 0.05 mL per plate, it was hoped to minimise or eliminate any toxic effects of the vehicle that may have otherwise occurred.
Experiment 1 treatments of all the tester strains were performed in the absence and in the presence of S-9, using final concentrations of Methylfuranoside at 5, 15.81, 50, 158.1, 500, 1581 and 5000 µg/plate, plus negative (vehicle) and positive controls.
Experiment 2 treatments of all the tester strains were performed in the absence and in the presence of S-9. The maximum test concentration of 5000 µg/plate was retained for all strains. Narrowed concentration intervals were employed covering the range 156.3 - 5000 µg/plate, in order to examine more closely those concentrations of Methylfuranoside approaching the maximum test concentration and considered therefore most likely to provide evidence of any mutagenic activity. - Evaluation criteria:
- For valid data, the test article was considered to be mutagenic if:
1. When assessed using Dunnett's test, an increase in revertant numbers gave a significant response (p < 0.01) which was concentration related.
2. The positive trend/effects described above were reproducible.
The test article was considered positive in this assay if all of the above criteria were met.
The test article was considered negative in this assay if none of the above criteria were met.
Results which only partially satisfied the above criteria were dealt with on a case by case basis. Biological relevance was taken into account, for example consistency of response within and between concentrations and (where applicable) between experiments. - Statistics:
- Dunnett's test
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- Experiment 1 treatments of all the tester strains were performed in the absence and in the presence of S-9, using final concentrations of Methylfuranoside at 5, 15.81, 50, 158.1, 500, 1581 and 5000 µg/plate, plus negative (vehicle) and positive controls. Following these treatments, no evidence of toxicity, as would usually be manifest by a diminution of the background bacterial lawn and/or a marked reduction in revertant numbers, was observed.
Experiment 2 treatments of all the tester strains were performed in the absence and in the presence of S-9. The maximum test concentration of 5000 µg/plate was retained for all strains. Narrowed concentration intervals were employed covering the range 156.3 - 5000 µg/plate, in order to examine more closely those concentrations of Methylfuranoside approaching the maximum test concentration and considered therefore most likely to provide evidence of any mutagenic activity. In addition, all treatments in the presence of S-9 were further modified by the inclusion of a pre incubation step. In this way, it was hoped to increase the range of mutagenic chemicals that could be detected using this assay system. Following these treatments, evidence of toxicity in the form of a slight thinning of the background bacterial lawn was observed at 2500 and/or 5000 µg/plate in all strains in the presence of S-9 only.
The test article was completely soluble in the aqueous assay system at all concentrations treated, in each of the experiments performed.
Mutation results
Following Methylfuranoside treatments of all the test strains in the absence and presence of S-9, no increases in revertant numbers were observed that were statistically significant when the data were analysed at the 1% level using Dunnett’s test. This study was considered therefore to have provided no evidence of any Methylfuranoside mutagenic activity in this assay system. - 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
It was concluded that Methylfuranoside did not induce mutation in five histidine requiring strains (TA98, TA100, TA1535, TA1537 and TA102) of Salmonella typhimurium when tested under the conditions of this study. These conditions included treatments at concentrations up to 5000 µg/plate (the maximum recommended concentration according to current regulatory guidelines), in the absence and in the presence of a rat liver metabolic activation system (S-9). - Executive summary:
Methylfuranoside was assayed for mutation in five histidine-requiring strains (TA98, TA100, TA1535, TA1537 and TA102) of Salmonella typhimurium, both in the absence and in the presence of metabolic activation by an Aroclor 1254-induced rat liver post-mitochondrial fraction (S-9), in two separate experiments.
All Methylfuranoside treatments in this study were performed using formulations prepared in anhydrous analytical grade dimethyl sulphoxide (DMSO).
Experiment 1 treatments of all the tester strains were performed in the absence and in the presence of S-9, using final concentrations of Methylfuranoside at 5, 15.81, 50, 158.1, 500, 1581 and 5000 µg/plate, plus negative (vehicle) and positive controls. Following these treatments, no evidence of toxicity was observed.
Experiment 2 treatments of all the tester strains were performed in the absence and in the presence of S-9. The maximum test concentration of 5000 µg/plate was retained for all strains. Narrowed concentration intervals were employed covering the range 156.3 - 5000 µg/plate, in order to examine more closely those concentrations of Methylfuranoside approaching the maximum test concentration and considered therefore most likely to provide evidence of any mutagenic activity. In addition, all treatments in the presence of S-9 were further modified by the inclusion of a pre-incubation step. In this way, it was hoped to increase the range of mutagenic chemicals that could be detected using this assay system. Following these treatments, evidence of toxicity in the form of a slight thinning of the background bacterial lawn was observed at 2500 and/or 5000 µg/plate in all strains in the presence of S-9 only.
The test article was completely soluble in the aqueous assay system at all concentrations treated, in each of the experiments performed.
Negative (vehicle) and positive control treatments were included for all strains in both experiments. The mean numbers of revertant colonies all fell within or slightly above acceptable ranges for negative control treatments, and were significantly elevated by positive control treatments.
Following Methylfuranoside treatments of all the test strains in the absence and presence of S-9, no increases in revertant numbers were observed that were statistically significant when the data were analysed at the 1% level using Dunnett’s test. This study was considered therefore to have provided no evidence of any Methylfuranoside mutagenic activity in this assay system.
It was concluded that Methylfuranoside did not induce mutation in five histidine-requiring strains (TA98, TA100, TA1535, TA1537 and TA102) of Salmonella typhimurium when tested under the conditions of this study. These conditions included treatments at concentrations up to 5000 µg/plate (the maximum recommended concentration according to current regulatory guidelines), in the absence and in the presence of a rat liver metabolic activation system (S-9).
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