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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
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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:
- 19 January 2022
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 022
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- Deviations:
- yes
- Remarks:
- No amendment was raised and one deviation occurred during the conduct of the study that WAF Trial was conducted on 31 January 2022 instead of 28 January 2022 and this deviation does not have any impact on outcome of the study.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Enzymatically produced steviol glycosides
- IUPAC Name:
- Enzymatically produced steviol glycosides
- Test material form:
- solid: particulate/powder
Constituent 1
Test solutions
- Vehicle:
- yes
- Remarks:
- reconstituted water
Test organisms
- Test organisms (species):
- Daphnia magna
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 48 h
- Post exposure observation period:
- no
Test conditions
- Hardness:
- Dose Range Finding Study (Day 0): 205.3 mg CaCO3/L;
Limit Test (Day 0): 230.3 mg CaCO3/L - Test temperature:
- Dose Range Finding Study: 20.1°C to 20.3°C;
Limit Test: 20.7°C to 20.9°C - pH:
- Dose Range Finding Study: 7.36 to 7.40;
Limit Test: 7.26 to 7.28 - Dissolved oxygen:
- Dose Range Finding Study: 7.88 to 7.96 mg/L;
Limit Test: 7.63 to 7.84 mg/L - Reference substance (positive control):
- yes
- Remarks:
- potassium dichromate (K2Cr2O7)
Results and discussion
Effect concentrations
- Duration:
- 48 h
- Dose descriptor:
- EL50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality
- Details on results:
- Dose Range Finding Study
Dose range finding study was conducted at the nominal loading rate of 0.01, 0.1, 1.0, 10.0, 50.0 and 100.0 mg/L. Daphnids were observed for the clinical signs of lethargy, erratic movement and localized on bottom of container. However, no such clinical signs and no immobility were observed up to highest loading rate of 100.0 mg/L and in control group during the 48 hours for exposure period.
During the dose range finding study, samples from all the nominal loading rates were collected at 0 hour (fresh) and at 48 hours (spent). The samples were analyzed for the determination of Total Organic Carbon (TOC) content.
Total organic carbon (TOC) content was found to be 0.4901, 0.5506, 1.390, 5.468, 24.85 and 48.14 ppm in fresh samples and 0.8361, 0.4862, 1.634, 4.813, 23.37 and 46.08 ppm in spent samples at the nominal loading rates of 0.01, 0.1, 1.0, 10.0, 50.0 and 100.0 mg/L respectively.
Limit Test
Based on results of the dose range finding study, limit test was performed as main study at the nominal loading rate of 100.0 mg/L along with control group.
Daphnids were observed for the clinical signs of lethargy, erratic movement and localized on bottom of container. However, no such clinical signs and no immobility were observed up to highest loading rate of 100 mg/L and in control group during the 48 hours for exposure period.
During the limit test, samples from nominal loading rate (100 mg/L) were collected at 0 hour (fresh) and at 48 hours (spent). The samples were analyzed for the determination of Total Organic Carbon (TOC) content.
Total organic carbon (TOC) content was found to be 44.29 and 46.39 ppm in fresh and spent sample respectively. - Results with reference substance (positive control):
- EC50=1.03 mg/L (24h);
EC50=0.68 mg/L (48h)
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- Based on the above results of the experiment and under experimental conditions employed, it is concluded that the 48 hours acute median effective loading rate (EL50) of Enzymatically produced steviol glycosides was >100 mg/L.
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