Registration Dossier
Registration Dossier
Diss Factsheets
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EC number: 807-130-4 | CAS number: 53716-82-8
- 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:
- PNEC STP
- PNEC value:
- 50 mg/L
- Assessment factor:
- 10
- Extrapolation method:
- assessment factor
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:
- PNEC soil
- PNEC value:
- 16 mg/kg soil dw
- Extrapolation method:
- equilibrium partitioning method
Hazard for predators
Secondary poisoning
- Hazard assessment conclusion:
- no potential for bioaccumulation
Additional information
When CyreneTM is in aqueous solution, the keto group (C=O) gains water (H2O) to form the corresponding Gem Diol {(1S,5R)-6,8-dioxabicyclo[3.2.1]octane-4,4-diol}. An equilibrium is established rapidly (meaning that the reaction is rapidly reversible). The ratio of the two forms is dependent upon the amount of water present.
Further information is available in the physical and chemical properties endpoint summary (IUCLID Section 4, CSR Section 1.4) and in the attached assessment report in Section 13 of IUCLID.
Under the conditions of the short-term aquatic toxicity studies (nominal concentrations up to 100 mg/l Cyrene™), the test organisms were exposed predominantly to the Gem Diol form. Since this is the relevant form under dilute environmental conditions, the data are considered to be appropriate for the purposes of environmental hazard assessment and classification.
Measured, short-term aquatic toxicity data are available with the registration substance. No effects on the test organisms were reported at the highest test concentrations of 100 mg/l.
Long-term aquatic toxicity to fish and Daphnia data have been generated using an appropriate predictive model, ECOSAR v.2.0, using the properties of the Gem Diol. Toxicity to aquatic algae data have also been predicted for completeness, and to compare the estimated sensitivities of the test organisms. The predicted NOEC values are all ≥985 mg/l.
In the absence of short-term toxicity in the experimental tests, and toxicity predicted only at concentrations well in excess of the highest test concentrations required by the relevant OECD test guidelines, no aquatic toxicity is expected at environmentally relevant concentrations, therefore PNECaquatic has not been derived.
However, the long-term predicted values have been used to derive an indicative PNECaquatic for use in the equilibrium partitioning calculation so that PNECsoil can be determined and a screening assessment can be carried out.
According to the QSAR predicted data, algae is the most sensitive trophic level in terms of short-term E(L)C50 values and also has the lowest NOEC value. The predicted algal NOEC is therefore used to derive the indicative PNECaquatic. An assessment factor of 10 is appropriate because long-term data are available for three trophic levels.
Conclusion on classification
Cyrene™ has reliable short-term E(L)C50 values for fish, invertebrates and algae of >100 mg/l. It has a reliable NOEC of ≥100 mg/l in algae.
The registered substance is readily biodegradable. The aquatic toxicity studies and biodegradation studies reflect the form of the substance present in environmentally relevant scenarios.
These data are consistent with the following classification under Regulation (EC) No 1272/2008 (as amended) (CLP):
Acute toxicity: Not classified.
Chronic toxicity: Not classified.
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