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Diss Factsheets
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EC number: 938-754-6 | 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
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Ecotoxicological Summary
Administrative data
Hazard for aquatic organisms
Freshwater
- Hazard assessment conclusion:
- PNEC aqua (freshwater)
- PNEC value:
- 0.016 mg/L
- Assessment factor:
- 1 000
- Extrapolation method:
- assessment factor
- PNEC freshwater (intermittent releases):
- 0.16 mg/L
Marine water
- Hazard assessment conclusion:
- PNEC aqua (marine water)
- PNEC value:
- 0.002 mg/L
- Assessment factor:
- 10 000
- Extrapolation method:
- assessment factor
STP
- Hazard assessment conclusion:
- PNEC STP
- PNEC value:
- 100 mg/L
- Assessment factor:
- 100
- Extrapolation method:
- assessment factor
Sediment (freshwater)
- Hazard assessment conclusion:
- no exposure of sediment expected
Sediment (marine water)
- Hazard assessment conclusion:
- no exposure of sediment expected
Hazard for air
Hazard for terrestrial organisms
Soil
- Hazard assessment conclusion:
- no exposure of soil expected
Hazard for predators
Secondary poisoning
- Hazard assessment conclusion:
- no potential for bioaccumulation
Additional information
Ecotoxicity studies in fish, daphnia, algae and bacteria with Sucroglyceride C12‐18, C18unsatd. did not show acute toxicity values < 1 mg/L.
Short-term toxicity studies
The 96 h-LC50 for fish obtained from a short-term toxicity study in Leuciscus idus (Golden Orfe) was 136 mg/L. A Daphnia sp. Acute Immobilisation Test resulted in a 48 h-LC50 of 28.5 mg/L. A 72 hour acute toxicity study in Pseudokirchneriella subcapitata resulted in an EC50 of 16 mg/L.
Long-term toxicity studies
In accordance with REACH Annex IX, 9.1.5 column 2, long-term toxicity testing to aquatic organisms does not need to be conducted. A test for long-term toxicity to aquatic organisms is only required, if the chemical safety assessment according to Annex I indicates the need to investigate further the effects on aquatic organisms. The choice of the appropriate test(s) depends on the results of the chemical safety assessment. As the registration substance does not need to be classified with regard to environmental effects, an exposure assessment is not required. The long-term exposure of aquatic organisms is unlikely as the substance is readily biodegradable. The ready biodegradability of the substance is proved in a number of tests conducted under different conditions (aerobic, anaerobic).
Toxicity to microorganisms
In a 1 hour toxicity study conducted according to DIN 38412 part 27 (Bacteria Respiration Test), cultures of Pseudomonas putida were exposed to Sucroglyceride C12-18, C18unsatd. at nominal concentration of 10 g/L under static conditions. No inhibition of the bacterial respiration with the tested concentration was observed.
The test conditions did not meet the current standards for PNEC derivation as given in TGD on risk assessment. However, the study is considered acceptable, because Sucroglyceride C12-18, C18unsatd. is readily biodegradable. In accordance with column 2 of REACH Annex VIII, the activated sludge respiration inhibition test does not need to be conducted as this substance was found to be readily biodegradable and the applied test concentrations are in the range of concentrations that can be expected in the influent of a sewage treatment plant.
It is considered appropriate to use the result obtained in the Bacteria Respiration Test according to DIN 38412 part 27 as starting point for PNEC derivation without conducting a further Activated Sludge Test (OECD guideline 209).
The DIN 38412 part 27-test is similar to OECD guideline 209, but uses only one species and an incubation time of only 1 hour. This fact is compensated by using a rather conservative assessment factor of 100 for PNEC derivation.
Bioaccumulation
Bioaccumulation in organisms is considered to be low. Therefore, secondary poisoning through the food chain is of no concern for Sucroglyceride C12‐18, C18unsatd.The substance is readily biodegradable, which will result in low environmental concentrations. Sucroglyceride C12‐18, C18unsatd. is metabolised in higher organisms. The substances are de-esterified and further degraded via the fatty-acid and glucose metabolic pathway.
Ozone layer
According to a low vapour pressure of the substance, the predicted environmental fate is not the atmosphere. The registration substance is not expected to reach the atmospheric stratosphere and therefore is not expected to present a danger to the structure and/or the functioning of the stratospheric ozone layer.
Conclusion on classification
In conclusion, ecotoxicity studies with Sucroglyceride C12‐18, C18unsatd. did not show acute toxicity values < 1 mg/L.
Further, the substance proved to be readily biodegradable under aerobic as well as anaerobic conditions. According to Directive 67/548/EEC, Sucroglyceride C12‐18, C18unsatd. does not need to be classified as “dangerous to the environment” and therefore labelling is not applicable.
According to GHS Regulation EC No 1272/2008, Sucroglyceride C12‐18, C18unsatd. does not need to be classified as “hazardous to the aquatic environment” and does not need to be classified as “hazardous to the ozone layer”. Therefore labelling is not applicable.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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