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Diss Factsheets
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EC number: 700-786-1 | 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
Link to relevant study record(s)
- Endpoint:
- biodegradation in water: ready biodegradability
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 301 B (Ready Biodegradability: CO2 Evolution Test)
- Deviations:
- not specified
- GLP compliance:
- yes
- Oxygen conditions:
- aerobic
- Inoculum or test system:
- activated sludge, non-adapted
- Details on inoculum:
- The sludge was taken from the activation basin of the domestic sewage treatment plant in D-67480 Edenboken. It was filtrated, washed with tap water twice, then washed with and resuspended in test medium. It was then aerated. The dry matter was determined with 4040 mg suspended solids/liter
- Duration of test (contact time):
- ca. 29 d
- Initial conc.:
- ca. 20 mg/L
- Based on:
- COD
- Parameter followed for biodegradation estimation:
- inorg. C analysis
- Reference substance:
- aniline
- Parameter:
- other: % biodegradation
- Value:
- ca. 19.4
- Sampling time:
- 4 d
- Remarks on result:
- other: mean
- Parameter:
- other: % biodegradation
- Value:
- ca. 46.8
- Sampling time:
- 9 d
- Remarks on result:
- other: mean
- Parameter:
- other: % biodegradation
- Value:
- ca. 60.3
- Sampling time:
- 11 d
- Remarks on result:
- other: mean
- Parameter:
- other: % biodegradation
- Value:
- ca. 72.5
- Sampling time:
- 15 d
- Remarks on result:
- other: mean
- Parameter:
- other: % biodegradation
- Value:
- ca. 76.6
- Sampling time:
- 29 d
- Remarks on result:
- other: mean
- Validity criteria fulfilled:
- yes
- Interpretation of results:
- readily biodegradable
- Conclusions:
- The test item SOPHOROLIPIDS is considered as "readily biodegradable",
The degree of biodegradation reached 76.6 % after 28days,
The 10 days window began on day 3, at its end; 68 % were reached surpassing the pass level of 60% given in the OECD guideline,
The abiotic degradation was <2%
Reference
Description of key information
Sophorolipids underwent 76.6% biodegradation after 28 days in an OECD 301B ready biodegradability study. The 10-day window criterion was also fulfilled. Therefore the registered substance and its underlying constituents are considered readily biodegradable.
Key value for chemical safety assessment
- Biodegradation in water:
- readily biodegradable
Additional information
- Detergents Ingredients Database (DID-list) Part A. List of ingredients 2016.
https://ec.europa.eu/environment/ecolabel/documents/DID%20List%20PART%20A%202016%20FINAL.pdf
The aerobic ready biodegradability of Sophorolipids has been determined in the CO2 Evolution Test following OECD 301B and EU-Method C.4-C using a test item concentration of nominally 20mg organic carbon/l (corresponding to 54.7 mg Sophorolipids /L). Aniline was chosen as positive control. Activated sludge was used as inoculum (concentration 25mg dry matter /L). The test duration was 28 days. All validity criteria were met. The degradation of the positive control was 63% after nine days.
The following data were determined for the test item SOPHOROLIPIDS:
10 day window: day 3-13
Degradation at the end of the 10 day window: 68%
Degradation at the end of the test: 77%
Pass level: 60% at the end of the 10 day window
Therefore, it was concluded that Sophorolipids is readily biodegradable following OECD 301B/EU C.4-C.
The registered substance is a UVCB substance. ECHA guidance on PBT assessment (Chapter R.11) notes that it is difficult to assess persistence of complex substances containing many constituents using biodegradation methods that measure summary parameters (such as evolution of carbon dioxide or theoretical oxygen demand). In the case of multi-constituent and UVCB substances, the following general strategy is suggested for P assessment (R.11.1.4.2). If the substance consists of homologous structures and is shown to meet the stringent ultimate ready biodegradation test criterion (>60% in 28 days), it can be concluded that the underlying constituents comprising the complex substances are not expected to be persistent.
The registered substance, Sophorolipids, is the fermentation products of glucose and rapeseed-oil fatty acids methyl esters. The identified constituents are shown in attached figure 1. These include lactone A (CAS 141304-59-8, 15-40% w/w concentration range), lactone A’ (CAS 1400527-63-0, ≤10% w/w), the corresponding “ring-opened” methyl esters (Product B, 10-40% and Product C, 5-25%) and the corresponded “ring-opened” carboxylic acid (Product D, 5-25%). Oleic acid (CAS 112-80-1, ≤15% w/w) and linoleic acid (CAS 60-33-3, ≤3% w/w) may also be present.
Constituents A, A’, B, C and D are closely related structural analogues that are expected to undergo similar biodegradation pathways. The most likely biodegradation pathway for lactones and esters is hydrolysis to give the corresponding hydroxycarboxylate and alcohol + carboxylate. This would result in a common degradation product for constituents A, B and D (i.e. degradation product 1, figure 2). Similarly, A’ and C would produce the related degradation product 2 (Figure 2). It is expected that these degradation products would undergo further degradation, most likely via beta-oxidation of the fatty acid chain resulting in a disaccharide-type moiety. Bacteria produce a large number of enzymes for breaking down polysaccharides / disaccharides with these substances generally recognised as readily biodegradable (DID No. 2551, reference 1). Fatty acids, such as oleic acid and linoleic acid that may be present in the registered substance, are also readily biodegradable (DID No.2520, reference 1). The high percentage of mineralisation observed in the OECD301B study (77% after 28 days) for the tested Sophorolipids, supports the ready biodegradation of its underlying constituents.
To conclude, the registered substance and its underlying constituents are considered readily biodegradable and not persistent.
References
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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