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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
Toxicity to aquatic algae and cyanobacteria
Administrative data
- Endpoint:
- toxicity to aquatic algae and cyanobacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 21 - 30 November 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 201 (Freshwater Alga and Cyanobacteria, Growth Inhibition Test)
- Version / remarks:
- 23 March 2006, Annex 5 corrected 28 July 2011
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.3 (Algal Inhibition test)
- Version / remarks:
- 20 May 2008, amended 7 December 2015, for the purpose of its adaptation to technical progress, by Commission Regulation (EU) 2016/266
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- determination of total phosphorus was performed by a third laboratory under the QA system ISO/IEC 17025 and is therefore excluded from the statement of GLP compliance
Test material
- Reference substance name:
- Fructose-1,6-Diphosphate, raw: Glucose anaerobically fermented by Saccharomyces cerevisiae, concentrated, phosphorylated
- Molecular formula:
- Molecular formula of the eponymous compound: C6H14O12P2
- IUPAC Name:
- Fructose-1,6-Diphosphate, raw: Glucose anaerobically fermented by Saccharomyces cerevisiae, concentrated, phosphorylated
- Test material form:
- solid
- Details on test material:
- Batch No.: 18224600
Constituent 1
Sampling and analysis
- Analytical monitoring:
- yes
Test solutions
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
The following test flasks were set up:
- Test solution (Tn); containing test medium, test item and algae (six replicates)
- Blank control (Bn); containing test medium and algae (six replicates)
- Since the test item is soluble, the test solution was prepared by dissolving 100 mg/l of test item in sterile-filtered algal medium (pH adjusted at 8.0±0.2) in sterile glassware and stirred for 10 minutes. 100 ml of the resulting test solution were added to each of the sterile test flasks and inoculated with an exponentially
growing preculture of algae. Samples for the determination of the test concentrations were taken from the remaining test solution.
Pure algal medium, handled as the test item solutions inoculated with the exponentially growing preculture of algae mentioned above, served as blank controls. For the incubation, the test flasks were then placed on an orbital shaker at a nominal shaking speed of about 130 revolutions per min.
- Evidence of undissolved material: Not relevant. Since the test item is soluble, the test solution was prepared by dissolving 100 mg/l of test item in sterile-filtered algal medium (pH adjusted at 8.0±0.2)
Test organisms
- Test organisms (species):
- Desmodesmus subspicatus (previous name: Scenedesmus subspicatus)
- Details on test organisms:
- TEST ORGANISM
- Test organism: Axenic slope culture of Desmodesmus subspicatus 86.81SAG (Collection of Algal Cultures, Institute of Freshwater Ecology, University of Göttingen, D-37073 Göttingen, Germany
- Culture: 250 ml flask containing 100 ml of sterile OECD medium inoculated with cell material from an axenic slope culture
- Illumination: Continuous (2000–3000 lux) from Osram Fluora L18W77 and Osram Daywhite L18W840 (Osram AG, Winterthur, Switzerland)
- Temperature: 21 to 24°C, maintained at ± 2°C in a thermo-controlled room
- Control of sensitivity: twice per year, with potassium dichromate
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 72 h
Test conditions
- Hardness:
- not reported
- Test temperature:
- Min: 22.4; Max: 23.0; Mean: 22.5
- pH:
- 6.9 - 7.6
- Dissolved oxygen:
- not reported
- Salinity:
- not reported
- Conductivity:
- not reported
- Nominal and measured concentrations:
- Fructose-1,6-Diphosphate, raw: Glucose anaerobically fermented by Saccharomyces cerevisiae, concentrated, phosphorylated in the test medium was measured by phosphorus-analytics at the beginning and at the end of the test.The measured P concentration at the beginning of the test was 14.3 mg/l; and 13.7 mg/l at the end of the test.
Considering a P content of 11.77%, this corresponds to a test item concentration of 121 mg/l at the beginning and 116 mg/l at the end of the test (96% of the initially measured concentration), respectively. Conclusions about its stability cannot however be drawn, since this quantification method is not substance-specific. The concentration at the beginning was not within 80-120% of the nominal concentration, and therefore, the effective concentrations ErCx/EyCx as well as the NOErC and NOEyC were assessed based on the geometric mean of the measured concentration of the test item over the whole 72 h test period. - Details on test conditions:
- TEST SYSTEM
- Test vessel: 250 ml flasks, all-glass, with 100 ml of test medium, shaken (130 rpm), capped with air permeable stoppers
- Test medium: Recommended OECD medium
- Preculture: Exponentially growing culture of Desmodesmus subspicatus
- Illumination: Source: continuous from Osram Fluora L 18W77 and Osram Daywhite L 18W840 (Osram AG, Winterthur, Switzerland)
- Light intensity: the light intensity amounts to about 3000 lux which corresponds to about 40 µE•m-2•s-2
- Homogeneity: the light intensity is maintained within ±15% from the average light intensity over the incubation area. The test vessels are repositioned every day within the incubation area to minimize variation.
- Temperature: 21 to 24°C, maintained at ± 2°C in a thermo-controlled room
- pH: Initially adjusted to 8 ± 0.2; the pH of the control medium should not increase by more than 1.5 units during the test
- Test type: Static exposure conditions over a period of 72 h
- Starting cell density: 0.5–0.85 µg/ml with respect to dry weight corresponding to about 2–5•103 cells/ml (i.e. OD680 of about 0.005 units)
RANGE FINDING STUDY
Prior to the definitive test a non-GLP range finding test with nominal concentrations of 1, 10 and 100 mg/l of Fructose-1,6-Diphosphate, raw: Glucose anaerobically fermented by Saccharomyces cerevisiae, concentrated, phosphorylated was performed. The P determinations indicate that the test item concentrations were correctly dosed. Conclusions about their stability cannot however be drawn, since this quantification method is not substancespecific.
EFFECT PARAMETERS MEASURED
- Cell density: Cell concentrations were determined every 24 h using a spectrophotometer at 680 nm wavelength (Shimadzu UV 1800, Shimadzu Schweiz GmbH, Römerstr. 3, CH-4153 Reinach). Aliquots of 5 ml were removed from each test flask under sterile conditions. Cell concentrations at time 0 h were only determined in the blank controls. - Reference substance (positive control):
- not required
- Remarks:
- Control of sensitivity: None – the culture is re-purchased annually
Results and discussion
Effect concentrationsopen allclose all
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 119 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Key result
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 119 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 119 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- biomass
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 119 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- biomass
- Details on results:
- - Exponential growth in the control (for algal test): yes
- Any stimulation of growth found in any treatment: yes (growth rate and yield)
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: no
With respect to the endpoint growth rate, no significant effects were observed as compared to the blank controls.
Based on these effects and the nominal concentrations of the test item, the median effect concentration with respect to growth rate (ErC50/0–3 days) of Fructose-1,6-Diphosphate, raw: Glucose anaerobically fermented by Saccharomyces cerevisiae, concentrated, phosphorylated (EC no. 944-754-7) to Desmodesmus subspicatus was estimated to be >119 mg/l measured concentration.
The no observed effect concentration (NOErC) with respect to growth rate was determined to be 119 mg/l measured concentration.
With respect to the endpoint yield (biomass production), no significant effects were observed as compared to the blank controls.
Based on these effects and the nominal concentrations of the test item, the median effect concentration with respect to yield (EyC50/0–3 days) Fructose-1,6-Diphosphate, raw: Glucose anaerobically fermented by Saccharomyces cerevisiae, concentrated, phosphorylated (EC no. 944-754-7) to Desmodesmus subspicatus was estimated to be >119 mg/l measured concentration.
The no observed effect concentration (NOEyC) with respect to yield was determined to be 119 mg/l measured concentration. - Reported statistics and error estimates:
- Statistical analysis was performed with respect to the no observed effect concentrations. The statistical analysis was conducted with the software ToxRat® Standard Version 3.2.1.
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Remarks:
- In the control cultures: average specific growth rate of 1.49 (>0.92)/coefficient of variation of average specific growth rates: 0.7% (<=7%)/ mean coefficient of variation for section-by-section specific growth rates 21% (<=35%).
- Conclusions:
- The acute toxicity of Fructose-1,6-Diphosphate, raw: Glucose anaerobically fermented by Saccharomyces cerevisiae, concentrated, phosphorylated (EC no. 944-754-7) to Desmodesmus subspicatus was determined in a 72 hour static test according to OECD guideline 201. The median effect concentration with respect to growth rate (ErC50/0–3 days) of Fructose-1,6-Diphosphate, raw: Glucose anaerobically fermented by Saccharomyces cerevisiae, concentrated, phosphorylated to Desmodesmus subspicatus was estimated to be >119 mg/l measured concentration. The no observed effect concentration (NOErC) with respect to growth rate was determined to be 119 mg/l measured concentration. The results of the test can be considered reliable without restriction.
- Executive summary:
The growth inhibitory effects of Fructose-1,6-Diphosphate, raw: Glucose anaerobically fermented by Saccharomyces cerevisiae, concentrated, phosphorylated (EC no. 944-754-7) to the green alga Desmodesmus subspicatus were investigated according to test guideline OECD 201, over a period of 72 h.
The test item Fructose-1,6-Diphosphate, raw: Glucose anaerobically fermented by Saccharomyces cerevisiae, concentrated, phosphorylated is a UVCB substance, solid, pure and with a high solubility (>=882 g/l at pH 4 and at 22°C). Consequently, the test solution was prepared by dissolving the test item in sterile algal medium.
The only nominal concentration tested was 100 mg/l. Six parallel test vessels were used for the test item and six for the blank controls.
The concentration of Fructose-1,6-Diphosphate, raw: Glucose anaerobically fermented by Saccharomyces cerevisiae, concentrated, phosphorylated in the test medium was measured by phosphorus-analytics at the beginning and at the end of the test. These analyses revealed that the test concentration was 121 mg/l at the beginning and 116 mg/l at the end of the test (96% of the initially measured concentration). Conclusions about its stability cannot however be drawn, since this quantification method is not substance-specific. The concentration at the beginning was not within 80-120% of the nominal concentration, and therefore, the effective concentrations ErCx/EyCx as well as the NOErC and NOEyC were assessed based on the geometric mean of the measured concentration of the test item over the whole 72 h test period.
With respect to the endpoint growth rate, no significant effects were observed at 100 mg/l nominal concentration, as compared to the blank controls.
With respect to the endpoint yield (algal biomass), no significant effects were observed at 100 mg/l nominal concentration, as compared to the blank controls.
Therefore, 72h ErC50 and EyC50 values of Fructose-1,6-Diphosphate, raw: Glucose anaerobically fermented by Saccharomyces cerevisiae, concentrated, phosphorylated (EC no. 944-754-7) on the green alga Desmodesmus subspicatus were estimated to be >119 mg/l measured concentration.
The NOErC and NOEyC values were both 119 mg/l measured concentration.
All validity criteria were fulfilled.
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