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Diss Factsheets
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EC number: 424-820-7 | 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:
- PNEC aqua (freshwater)
- PNEC value:
- 0.9 µg/L
- Assessment factor:
- 100
- Extrapolation method:
- assessment factor
- PNEC freshwater (intermittent releases):
- 0.9 µg/L
Marine water
- Hazard assessment conclusion:
- PNEC aqua (marine water)
- PNEC value:
- 0.09 µg/L
- Assessment factor:
- 1 000
- Extrapolation method:
- assessment factor
STP
- Hazard assessment conclusion:
- PNEC STP
- PNEC value:
- 5 mg/L
- Assessment factor:
- 10
- Extrapolation method:
- assessment factor
Sediment (freshwater)
- Hazard assessment conclusion:
- PNEC sediment (freshwater)
- PNEC value:
- 0.73 mg/kg sediment dw
- Extrapolation method:
- equilibrium partitioning method
Sediment (marine water)
- Hazard assessment conclusion:
- PNEC sediment (marine water)
- PNEC value:
- 0.073 mg/kg sediment dw
- 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:
- 0.086 mg/kg soil dw
- Extrapolation method:
- equilibrium partitioning method
Hazard for predators
Secondary poisoning
- Hazard assessment conclusion:
- PNEC oral
- PNEC value:
- 10 mg/kg food
- Assessment factor:
- 300
Additional information
All assessment and conversion factors used in the above PNEC calculations were taken from the ECHA guidance document "Guidance on information requirements and chemical safety assessment; Chapter R.10: Characterisation of dose [concentration]-response for environment" along with appropriate equations and methodologies.
Due to the very low water solubility of the substance (<1 mg/L), aquatic ecotoxicity testing, and thus PNEC derivations, were based on Water Accommodated Fractions (WAFs) of nominal concentrations of the registration material. This was considered the most reliable and environmentally relevant method of testing.
It was deemed appropriate to derive PNECs using the most sensitive aquatic endpoint, therefore the acute Daphnia data was used despite the existence of a chronic study with Daphnia. This is because the EL50 value of 0.09 mg/L for the acute Daphnia study fell below the NOELR (mortality, growth and reproduction) of 0.14 mg/L for the chronic Daphnia study, logically it would be expected that this chronic NOELR should fall below the acute EL50. Both studies were conducted in accordance with relevant OECD guidelines, it is believed this discrepancy is likely due to difficulties in preparing WAFs at such low nominal loading rates for a UVCB material such as EC 424-820-7. It was therefore deemed appropriate to base PNEC derivation on the most sensitive/worst case endpoint.
The guidance on information requirements and chemical safety assessment Chapter R.10 p.19 states that: "An assessment factor of 100 applies also to the lowest of two long-term results (e.g. EC10 or NOECs) covering two trophic levels when such results have not been generated from that showing the lowest L(E)C50 of the short-term tests. This should, however, not apply in cases where the acutely most sensitive species has an L(E)C50 value lower than the lowest long term result (e.g. EC10 or NOECs) value. In such cases the PNEC might be derived by using an assessment factor of 100 to the lowest L(E)C50 of the short-term tests." The short-term Daphnia EC50 of 0.09 mg/l was the most sensitive endpoint and thus subject to the assessment factor of 100.
Conclusion on classification
Using the criteria set out in CLP Regulation (EC) No 1272/2008 Part 4: Environmental Hazards (as amended) the material will be classified as H400 Aquatic Acute Category 1 and H410 Aquatic Chronic Category 1. This classification is based on the worst case aquatic toxicity value, Acute Daphnia 48h EC50 = 0.09 mg/L. It was deemed appropriate to derive the classification using the most sensitive acute aquatic endpoint, despite the existence of two chronic studies at two separate trophic levels. This is because the EL50 value of 0.09 mg/L for the acute Daphnia study fell below the NOELR of 0.14 mg/L for the chronic Daphnia study. Both studies were conducted in accordance with relevant OECD guidelines, it is believed this discrepancy is likely due to the difficulties in preparing WAF at such low nominal loading rates of a UVCB material. Therefore, classifications categories for hazards to the aquatic environment were based on the most stringent/worse case aquatic toxicity values. M factors were derived similarly (using acute values, as per guidance).
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.