Registration Dossier
Registration Dossier
Diss Factsheets
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EC number: 943-535-3 | 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

Ecotoxicological Summary
Administrative data
Hazard for aquatic organisms
Freshwater
- Hazard assessment conclusion:
- no hazard identified
Marine water
- Hazard assessment conclusion:
- no hazard identified
STP
- Hazard assessment conclusion:
- no hazard identified
Sediment (freshwater)
- Hazard assessment conclusion:
- no hazard identified
Sediment (marine water)
- Hazard assessment conclusion:
- no hazard identified
Hazard for air
Air
- Hazard assessment conclusion:
- no hazard identified
Hazard for terrestrial organisms
Soil
- Hazard assessment conclusion:
- no hazard identified
Hazard for predators
Secondary poisoning
- Hazard assessment conclusion:
- PNEC oral
- PNEC value:
- 6.67 mg/kg food
- Assessment factor:
- 300
Additional information
As the test material is a UVCB substance, toxicity cannot be contributed to any one constituent and any PNEC derived must be based on the nominal EC50 and NOEC values derived using Water Accommodated Fractions (WAF).
The hazard assessment conclusion for secondary poisoning (PNECoral) is 6.67 mg/kg food.However,the substance has a low potential to bioaccumulate, secondary poisoning is unlikely to occur, and in accordance with Annex IX, Section 9.3.2, Column 2 of REACH, testing need not be conducted. According to the mammalian toxicity data presented this substance is not classified as systemically toxic to mammals and has no other relevant classifications with respect to mammalian toxicity (i.e. it is not a carcinogen, mutagen or reproductive/developmental toxin). According to ECHA Guidance on information requirements and chemical safety assessment Chapter R.16: Environmental Exposure Estimation, an assessment of secondary poisoning only becomes necessary when a substance exhibits potential to cause toxic effects if accumulated in higher organisms and the substance is classified on the basis of relevant mammalian toxicity data. Since the test item is considered not to exhibit bioaccumulation potential and does not meet relevant classification criteria, a risk assessment covering secondary poisoning is not required. Furthermore, indirect exposure of humans to the substance via the environment can be excluded because significant release from the place of formulation or use is not anticipated (see details of ATIEL-ATC SpERCs).
Conclusion on classification
The test item exhibits no toxicity to fish or Daphnia at the maximum concentration of 100 mg/L WAF and statistical evidence of toxicity in algae at 100 mg/L WAF is considered to be the result of surfactant molecules surrounding the relatively small number of algae that are in solution and reducing their capacity to take up minerals. This effect occurs at a loading rate much higher than the experimentally determined water solubility, and is unlikely to be seen in the environment. As such, the EC50 values are higher than the range specified for classification as Aquatic Chronic 3 under the terms of Regulation (EC) No 1272/2008 even though the substance is not readily biodegradable and Log10 Kow is > 4. In the absence of true aquatic toxicity and with EC 50 values > 100 mg/L classification is not required.
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