Registration Dossier
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EC number: 203-161-7 | CAS number: 103-95-7
- 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:
- PNEC aqua (freshwater)
- PNEC value:
- 1.09 µg/L
- Assessment factor:
- 1 000
- Extrapolation method:
- assessment factor
- PNEC freshwater (intermittent releases):
- 10.92 µg/L
Marine water
- Hazard assessment conclusion:
- PNEC aqua (marine water)
- PNEC value:
- 0.11 µg/L
- Assessment factor:
- 10 000
- Extrapolation method:
- assessment factor
STP
- Hazard assessment conclusion:
- PNEC STP
- PNEC value:
- 1 mg/L
- Assessment factor:
- 100
- Extrapolation method:
- assessment factor
Sediment (freshwater)
- Hazard assessment conclusion:
- PNEC sediment (freshwater)
- PNEC value:
- 0.126 mg/kg sediment dw
- Assessment factor:
- 4.6
- Extrapolation method:
- equilibrium partitioning method
Sediment (marine water)
- Hazard assessment conclusion:
- PNEC sediment (marine water)
- PNEC value:
- 0.013 mg/kg sediment dw
- Assessment factor:
- 4.6
- Extrapolation method:
- equilibrium partitioning method
Hazard for air
Air
- Hazard assessment conclusion:
- no hazard identified
Hazard for terrestrial organisms
Soil
- Hazard assessment conclusion:
- PNEC soil
- PNEC value:
- 0.025 mg/kg soil dw
- Assessment factor:
- 1.13
- Extrapolation method:
- equilibrium partitioning method
Hazard for predators
Secondary poisoning
- Hazard assessment conclusion:
- PNEC oral
- PNEC value:
- 33.3 mg/kg food
- Assessment factor:
- 300
Additional information
Three studies on the acute aquatic toxicity of the substance are available with the following findings: Freshwater fish: LC50 = 1.092 mg/L; Freshwater invertebrates: EC50 = 1.4mg/L; Freshwater algae: EC50 = 3.8 mg/L.
Chronic aquatic toxicity data is only available for algae; the 96-hour NOEC is 0.70 mg/L (based on growth rate). No marine species were tested. No tests on toxicity to sediment-dwelling organisms or soil organisms are available.
The PNEC for the aquatic environment are derived from the lowest effect level observed in the available acute aquatic toxicity tests by applying the following assessment factors to the lowest L(E)C50 of 1.092 mg/L: PNEC aqua (freshwater): 1000; PNEC aqua (marine water): 10000; PNEC aqua (intermittent): 100.
PNEC STP is derived from the available study on microbial respiration inhibition study giving a EC50 (over 3 hours) of 100mg/L by applying an assessment factor of 100.
PNECs for sediment and soil are calculated from the aquatic PNECs with the equilibrium partitioning method according to ECHA guidance R.10.
PNEC sediment (freshwater/marine water): Wet weight PNECs are calculated with Ksusp-water = 28.95 m3/m3, density of suspended particles = 1150 kg/m3 (wet weight); conversion to dry weight is done with factor of 4.6. (PNEC sediment freshwater = 2.75E-2 mg/kg wet weight; PNEC sediment marine water = 2.75E-3 mg/kg wet weight).
PNEC soil: Wet weight PNECs are calculated with Ksoil-water = 34.06 m3/m3, density of soil = 1700 kg/m3 (wet weight); conversion to dry weight is done with factor of 1.13 (PNEC soil = 0.0219 mg/kg wet weight)
PNEC secondary poisoning was derived from the available information on repeated dose toxicity 300 mg/kg bw converting to PNECoral by i) by multiplying by a factor of 33.3 (Oryctolagus cuniculus, rabbit) to convert to a concentration (NOEC) and ii) dividing by an assessment factor of 300 (<28 day study) in accordance with ECHA R.10.8.
Conclusion on classification
Environmental classification and labelling of a substance is generally based on data from short-term aquatic toxicity results, the ready biodegradability of the substance and the measured octanol/water partition coefficient. Available adequate chronic toxicity data is also relevant for the assessment of long-term aquatic hazards (Regulation 286/2011/EC).
Short-term aquatic toxicity data is available for all three trophic levels. The lowest short-term L(E)C50 was for fish with a 96-hour LC50 value of 1.09 mg/l. Chronic aquatic toxicity data is only available for algae; the 96-hour NOEC is 0.70 mg/L (based on growth rate). Cyclamen aldehyde is readily biodegradable and has a log Kow of 3.4.
Based on the above data, Cyclamen aldehyde is classified as R51/53 according to Directive 67/548/EEC (DSD) and Aquatic Chronic 3 (H412) according to the CLP Regulation 1272/2008/EC & adaptation 286/2011/EC.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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