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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
Short-term toxicity to aquatic invertebrates
Administrative data
- Endpoint:
- short-term toxicity to aquatic invertebrates
- 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 202 (Daphnia sp. Acute Immobilisation Test)
- Version / remarks:
- 13 April 2004
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.2 (Acute Toxicity for Daphnia)
- Version / remarks:
- 30 May 2008
- 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 vessels were set up:
- Test solution (Tn); containing Daphnia medium with test item (four replicates with five Daphnia each)
- Blank control (Bn); containing pure Daphnia medium (four replicates with five Daphnia each)
- Since the test item is soluble, the test solution was prepared by dissolving 100 mg/l of test item in Daphnia medium. The resulting solution was used as the test solution in the toxicity test. Samples for the determination of the test concentrations were taken from the remaining solutions. Pure Daphnia medium served as blank controls.
- O2 concentration and pH were measured in the test medium for each concentration including the blank control. If the O2 concentration was too low (>5.0 mg/l required) the media was aerated by stirring. Afterwards, the media were filled into the test vessels (50 ml per vessel).
- Daphnia, aged less than 24 h and already acclimatized to the Daphnia medium, were then introduced into the test media, and the vessels were covered with a glass plate. The Daphnia were not fed during the test and the test vessels were not aerated.
- Static test conditions
- 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 Daphnia medium.
Test organisms
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISMS
- Test organism: Daphnia magna (Straus, 1820), derived from a healthy stock and not first brood progeny
- Breeding: Parental and young Daphnia held in 4 l glass aquaria (3 l medium) at 20±2°C
- Illumination: 16 h per day
- Medium: Continuously aerated Elendt M4 medium prepared with ultra-pure water (conductivity <1.5 µS/cm)
- Feed: Suspension of Desmodesmus subspicatus in Elendt M4 medium with an optical density OD680 of about 15 units
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 48 h
Test conditions
- Hardness:
- not reported
- Test temperature:
- 18–22°C, controlled at ±1 °C
- pH:
- 6.5 to 6.6
- Dissolved oxygen:
- The minimum dissolved oxygen concentration in the controls and the test vessels at the end of each 24 h-period was >=7.2 mg O2/l (required >=3 mg O2/l).
- Salinity:
- not reported
- Conductivity:
- 679 to 683 µS cm-1
- Nominal and measured concentrations:
- The concentrations of Fructose-1,6-Diphosphate, raw: Glucose anaerobically fermented by Saccharomyces cerevisiae, concentrated, phosphorylated in the test medium were determined by phosphorus-analysis at the beginning and at the end of the test. These analyses revealed that the test concentration was correctly dosed. Conclusions about its stability cannot however be drawn, since this quantification method is not substance-specific. The measured total P concentration at the beginning was 12.5 mg/l and 11.5 mg/l at the end of the test. With respect to a total P content of 11.77%, this corresponds to 106 and 97.8 mg/l, respectively, of the test item (e.g. 106 and 98%).
- Details on test conditions:
- TEST SYSTEM
- Test vessel: 100 ml beakers, all-glass, with 50 ml of test medium,covered with a glass plate to avoid evaporation and contamination of the test solutions with dust
- Test medium: Elendt M4 medium; prepared with ultra-pure water (conductivity <1.5 µS/cm)
- Number of Daphnia: 20 individuals per test concentration and for the blank, divided in 4 groups of 5 individuals
- Age: Less than 24 h
- Light: 16 h photoperiod a day, supplied by overhead white fluorescent tubes
- Temperature: 18–22 °C, controlled at ±1 °C
- pH: 6 to 9. The pH should normally not vary by more than 1.5units in one test.
- Feed: The Daphnia are not fed during the test
- Aeration: The test vessels were not aerated during the test.
- Test type: Static exposure conditions
- Test duration: 48 h
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.
EFFECT PARAMETERS MEASURED
Observed immobility (inability to swim) of the daphnids: Observations of immobile Daphnia were made after 24 and 48 h of exposure. Any abnormal behaviour or appearance was reported. - Reference substance (positive control):
- yes
- Remarks:
- Acute reference test with potassium dichromate conducted twice a year
Results and discussion
Effect concentrationsopen allclose all
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Key result
- Duration:
- 48 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Duration:
- 24 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Duration:
- 24 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Details on results:
- No significant effects (<=10% immobilization) were observed at 100 mg/l nominal concentration or in the blank controls, neither after 24 h of exposure nor after 48 h. Therefore, the median effect concentrations (EC50) of Fructose-1,6-Diphosphate, raw: Glucose anaerobically fermented by Saccharomyces cerevisiae, concentrated, phosphorylated (EC no. 944-754-7) on Daphnia magna after 24 h as well as after 48 h of exposure were estimated to be >100 mg/l nominal concentration.
The NOEC values after 24 h and after 48 h of exposure were both 100 mg/l nominal concentration. - Results with reference substance (positive control):
- Acute ref. test with K2Cr2O7 conducted twice a year. The EC50 value for the control of sensitivity for 24 h of exposure with K2Cr2O7 was estimated to be 0.89 mg/l (29.6.2016), which lies within the recomm. range of 0.6–2.1 mg/l acc. to OECD Guideline 202.
- Reported statistics and error estimates:
- The effective concentrations ECx were assessed based on the arithmetic mean of the geometric mean of the measured concentrations.
No statistical analysis was performed.
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Remarks:
- All validity criteria i.e. immobilization in the controls <=10% and O2 concentrations at the end of the test >=3 mg/L were fulfilled.
- Conclusions:
- The acute toxicity of Fructose-1,6-Diphosphate, raw: Glucose anaerobically fermented by Saccharomyces cerevisiae, concentrated, phosphorylated (EC no. 944-754-7) to Daphnia magna was determined in a 48 hour static test according to OECD guideline 202. The median effect concentrations (EC50) of Fructose-1,6-Diphosphate, raw: Glucose anaerobically fermented by Saccharomyces cerevisiae, concentrated, phosphorylated on Daphnia magna after 24 h as well as after 48 h of exposure were estimated to be >100 mg/l nominal concentration. The NOEC values after 24 h and after 48 h of exposure were both 100 mg/l nominal concentration. The results of the test can be considered reliable without restriction.
- Executive summary:
The acute toxicity of Fructose-1,6-Diphosphate, raw: Glucose anaerobically fermented by Saccharomyces cerevisiae, concentrated, phosphorylated (EC no. 944-754-7) to Daphnia magna was investigated according to test guideline OECD 202, under static exposure conditions over a period of 48 h.
The test item Fructose-1,6-Diphosphate, raw: Glucose anaerobically fermented by Saccharomyces cerevisiae, concentrated, phosphorylated is solid, has a high solubility (>=882 g/l at pH 4 and at 22°C) and is 100% pure (UVCB). The test medium was prepared by dissolving 100 mg/l of the test item in Daphnia medium.
The single investigated nominal concentration was 100 mg/l.
20 individuals, divided in 4 groups of 5 individuals, were used for the test concentration and for the blank control.
The concentrations of Fructose-1,6-Diphosphate, raw: Glucose anaerobically fermented by Saccharomyces cerevisiae, concentrated, phosphorylated in the test medium were determined by phosphorus-analysis at the beginning and at the end of the test. These analyses revealed that the test concentration was correctly dosed. Conclusions about its stability cannot however be drawn, since this quantification method is not substance-specific. The effective concentrations ECx were assessed based on the nominal concentrations.
No significant effects (<=10% immobilization) were observed at 100 mg/l nominal concentration or in the blank controls, neither after 24 h of exposure nor after 48 h.
Based on these results, the median effect concentrations (EC50) of Fructose-1,6-Diphosphate, raw: Glucose anaerobically fermented by Saccharomyces cerevisiae, concentrated, phosphorylated (EC no. 944-754-7) on Daphnia magna after 24 h as well as after 48 h of exposure were estimated to be >100 mg/l nominal concentration.
The NOEC values after 24 h and after 48 h of exposure were both 100 mg/l nominal concentration.
All validity criteria were fulfilled.
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