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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
Biodegradation in water: screening tests
Administrative data
- Endpoint:
- biodegradation in water: ready biodegradability
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 022
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 301 B (Ready Biodegradability: CO2 Evolution Test)
- Deviations:
- yes
- Remarks:
- Temperature range was 18.3 – 21.6 °C instead of 22 ± 2 °C. As degradation of the positive control was in the normal range this is considered as uncritical concerning the outcome of the study.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Fermentation product of sucrose and Theaceae Camellia Camellia sinensis leaves with a variable symbiosis of bacteria and yeast, of including bacteria of Acetoacteraceæ Acetobacter and Gluconobacter genus, and yeasts of Saccharomycetaceae family
- Molecular formula:
- Not applicable
- IUPAC Name:
- Fermentation product of sucrose and Theaceae Camellia Camellia sinensis leaves with a variable symbiosis of bacteria and yeast, of including bacteria of Acetoacteraceæ Acetobacter and Gluconobacter genus, and yeasts of Saccharomycetaceae family
- Test material form:
- liquid
- Details on test material:
- - Synthesis batch: KOMBUCHA R_001
- CAS no. : 100085-62-9
- Production date: 2021-10-11
- Expiry date: 2022-10-03
- Stability : stable under storage conditions
- Appearance : clear, dark yellow to orange liquid
- Storage in Test Facility: -15 to -25°C
Constituent 1
Study design
- Oxygen conditions:
- aerobic
- Inoculum or test system:
- activated sludge, domestic (adaptation not specified)
- Details on inoculum:
- Inoculum concentration: 25.0 mg/L
Temperature 18.3 – 21.6 °C without direct lighting - Duration of test (contact time):
- 28 d
Initial test substance concentration
- Initial conc.:
- 20 mg/L
- Details on study design:
- The test item in a mineral medium was inoculated and incubated under aerobic conditions in the dark. The amount of organic carbon in the test solution due to the inoculum was kept as low as possible compared with the amount of organic carbon due to the test item. Allowance was made for the endogenous activity of the inoculum by running parallel blanks with inoculum but without test item. A positive control was run in parallel to check the operation of the procedures. Degradation was followed by determining the carbon dioxide produced. Measurements were taken at sufficiently frequent intervals to allow the identification of the beginning and end of biodegradation.
Results and discussion
% Degradationopen allclose all
- Parameter:
- % degradation (test mat. analysis)
- Value:
- 18.6
- Sampling time:
- 2 d
- Parameter:
- % degradation (inorg. C analysis)
- Value:
- 45.4
- Sampling time:
- 4 d
- Parameter:
- % degradation (inorg. C analysis)
- Value:
- 57.7
- Sampling time:
- 7 d
- Parameter:
- % degradation (inorg. C analysis)
- Value:
- 65.6
- Sampling time:
- 9 d
- Parameter:
- % degradation (inorg. C analysis)
- Value:
- 67.7
- Sampling time:
- 11 d
- Parameter:
- % degradation (test mat. analysis)
- Value:
- 72.4
- Sampling time:
- 14 d
- Parameter:
- % degradation (inorg. C analysis)
- Value:
- 72.6
- Sampling time:
- 18 d
- Parameter:
- % degradation (inorg. C analysis)
- Value:
- 77.8
- Sampling time:
- 23 d
- Parameter:
- % degradation (test mat. analysis)
- Value:
- 78.8
- Sampling time:
- 29 d
- Details on results:
- The test item Kombucha;Echa name: "Fermentation product of sucrose and Camellia sinensis (Theaceae) leaves with a variable symbiosis of bacteria and yeast, including various Acetoacteraceæ bacteria and Saccharomycetaceae yeasts" is considered as “readily biodegradable“.
The degree of biodegradation reached 79 % after 28 days.
The 10-day-window began on day 1, at its end, 68 % degradation were reached, surpassing
the pass level of 60 % given in the OECD guideline.
Because the test item is a mixture, the 10-day window has not to be taken into account.
As degradation reached the pass level of 60% in the course of the test, Kombucha;Echa name: "Fermentation product of sucrose and Camellia sinensis (Theaceae) leaves with a variable symbiosis of bacteria and yeast, including various Acetoacteraceæ bacteria and Saccharomycetaceae yeasts" is considered as readily biodegradable, within 28 days.
The abiotic degradation reached 0.7 %.
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Interpretation of results:
- readily biodegradable
- Conclusions:
- As degradation reached the pass level of 60% in the course of the test, Kombucha;Echa name: "Fermentation product of sucrose and Camellia sinensis (Theaceae) leaves with a variable symbiosis of bacteria and yeast, including various Acetoacteraceæ bacteria and Saccharomycetaceae yeasts" is considered as readily biodegradable, within 28 days.
- Executive summary:
The test item Kombucha; Echa name: "Fermentation product of sucrose and Camellia sinensis (Theaceae) leaves with a variable symbiosis of bacteria and yeast, including various Acetoacteraceæ bacteria and Saccharomycetaceae yeasts" was tested using a concentration of nominally 20 mg organic carbon/L Kombucha;Echa name: "Fermentation product of sucrose and Camellia sinensis (Theaceae) leaves with a variable symbiosis of bacteria and yeast, including various Acetoacteraceæ bacteria and Saccharomycetaceae yeasts" in test medium following OECD 301B and EU-Method C.4-C.
Aniline was chosen as positive control.
Activated sludge was used as inoculum (concentration in the test 25.0 mg dry matter/L). The test was left running for 28 days.
All validity criteria were met. Degradation of the positive control surpassed the pass level of 60 % after 7 days.The following data were determined for the test item Kombucha;Echa name: "Fermentation product of sucrose and Camellia sinensis (Theaceae) leaves with a variable symbiosis of bacteria and yeast, including various Acetoacteraceæ bacteria and Saccharomycetaceae yeasts":
10-day-window: day 1 – 11
- degradation at the end of 10-day-window 68 %
- degradation at the end of the test 79 %
- pass level following guideline: 60 % at the end of 10-day-window for pure substances; respective 60 % at the end of the test for mixtures
Therefore, when applying the 10-day-window, Kombucha;Echa name: "Fermentation product of sucrose and Camellia sinensis (Theaceae) leaves with a variable symbiosis of bacteria and yeast, including various Acetoacteraceæ bacteria and Saccharomycetaceae yeasts" is readily biodegradable following OECD 301B and EU C.4-C respectively.
Because the test item is a mixture the 10-day-window does not have to be taken into account. As degradation reached the pass level of 60% in the course of the test, Kombucha;Echa name: "Fermentation product of sucrose and Camellia sinensis (Theaceae) leaves with a variable symbiosis of bacteria and yeast, including various Acetoacteraceæ bacteria and Saccharomycetaceae yeasts" is considered as readily biodegradable, within 28 days.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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