Registration Dossier
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EC number: 275-156-8 | CAS number: 71048-82-3
- 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:
- 7 µg/L
- Assessment factor:
- 50
- Extrapolation method:
- assessment factor
- PNEC freshwater (intermittent releases):
- 3.5 µg/L
Marine water
- Hazard assessment conclusion:
- PNEC aqua (marine water)
- PNEC value:
- 0.7 µg/L
- Assessment factor:
- 500
- Extrapolation method:
- assessment factor
STP
- Hazard assessment conclusion:
- PNEC STP
- PNEC value:
- 2.41 mg/L
- Assessment factor:
- 100
- Extrapolation method:
- assessment factor
Sediment (freshwater)
- Hazard assessment conclusion:
- PNEC sediment (freshwater)
- PNEC value:
- 906 µg/kg sediment dw
- Extrapolation method:
- equilibrium partitioning method
Sediment (marine water)
- Hazard assessment conclusion:
- PNEC sediment (marine water)
- PNEC value:
- 90.6 µg/kg sediment dw
- Extrapolation method:
- equilibrium partitioning method
Hazard for air
Hazard for terrestrial organisms
Soil
- Hazard assessment conclusion:
- PNEC soil
- PNEC value:
- 177 µg/kg soil dw
- Extrapolation method:
- equilibrium partitioning method
Hazard for predators
Secondary poisoning
- Hazard assessment conclusion:
- PNEC oral
- PNEC value:
- 0.074 mg/kg food
- Assessment factor:
- 90
Additional information
Two studies are available for the short-term toxicity of delta-damascone to fish. One study is a semi-static GLP-compliant OECD 203 study with medaka (Oryzias latipes) (Kurume Laboratory, 2009). The concentrations were analytically verified, the 96-h LC50 was 0.97 mg/L based on measured concentrations. The other study is also a semi-static GLP-compliant OECD 203 study with the same species. The 96-h LC50 was 0.977 mg/L based on nominal concentrations (Kurume Laboratory, 2007b). The most critical value is used in the assessment, which is the 96-h LC50 of 0.97 mg/L.
No data is available on long-term toxicity in fish.
No short-term study on invertebrates is available, but instead a semi-static GLP compliant, OECD 211 study is available regarding long-term toxicity of delta-damascone to Daphnia magna (Huntingdon Life Sciences Ltd, 2009c). The concentrations were analytically verified and the 21-d NOEC for reproduction was 0.35 mg/L, this value is used in the assessment.
One GLP compliant OECD 201 study is available for growth inhibition of delta-damascone to Pseudokirchneriella subcapitata (Huntingdon Life Sciences Ltd, 2009d). The concentrations were analytically verified. The 72-h EbC50 was 2.47 mg/L, the 72-h ErC50 and NOErC were 4.54 mg/L and 0.883 mg/L, respectively. The effect concentrations based on growth rate are used in the assessment.
One GLP-compliant OECD 209 respiration inhibition study with micro-organisms is available for delta-damascone (Huntingdon Life Sciences Ltd, 2009e). The 3-h EC50 was 241 mg/L, this value is used in the assessment.
Data on sediment, terrestrial and bird toxicity is not available.
Conclusion on classification
According to the Amendment to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008 dDamascone needs to be labelled as Acute Toxicity Category 1 (Very toxic to aquatic life; H400) as the lowest L(E) C50 value (96-h LC50 of 0.97 mg/L in Oryzias latipes) is below the limit of 1 mg/L. Based on the lowest available chronic NOEC for Daphnia between 0.1 and 1 mg/L (NOEC = 0.35 mg/L in aquatic invertebrates) and the substance being not rapidly degradable, dDamascone needs to be classified as Aquatic Chronic 2 (Toxic to aquatic life with long lasting effects; H411). However, based on acute data in combination with the non rapid degradability, the chronic classification based on acute ecotoxicity data will become H410 (Very toxic to aquatic life with long lasting effects) as the most stringent outcome needs to be taken.
According to the Dangerous Substance Directive 67/548/EC, the available ecotoxicological and environmental fate data warrants classification as N; R50/53 (Very toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment).
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