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EC number: 700-503-1 | CAS number: 101238-01-1
- 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:
- 0.001 mg/L
- Assessment factor:
- 500
- Extrapolation method:
- assessment factor
- PNEC freshwater (intermittent releases):
- 0.003 mg/L
Marine water
- Hazard assessment conclusion:
- PNEC aqua (marine water)
- PNEC value:
- 0 mg/L
- Assessment factor:
- 10 000
- Extrapolation method:
- assessment factor
STP
- Hazard assessment conclusion:
- PNEC STP
- PNEC value:
- 9.5 mg/L
- Assessment factor:
- 10
- Extrapolation method:
- assessment factor
Sediment (freshwater)
- Hazard assessment conclusion:
- PNEC sediment (freshwater)
- PNEC value:
- 1.03 mg/kg sediment dw
- Extrapolation method:
- equilibrium partitioning method
Sediment (marine water)
- Hazard assessment conclusion:
- PNEC sediment (marine water)
- PNEC value:
- 0.051 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:
- 1 mg/kg soil dw
- Assessment factor:
- 1 000
- Extrapolation method:
- assessment factor
Hazard for predators
Secondary poisoning
- Hazard assessment conclusion:
- no potential for bioaccumulation
Additional information
In case of the present compound the regular short-term toxicity tests on fish, daphnids and algae are available according to the OECD guidelines 203, 202 and 201 and corresponding L(E)C50 values were determined. Additionally, a toxicity study on Lemna gibba (OECD 221) and a screening study on Daphnia in the presence of low concentrations of humic acid were conducted. Table 1 gives on overview of the results.
Table 1: Overview of the toxicity tests on fish, daphnids and algae as well as the additional tests on Lemna gibba and Daphnia magna with humic acid.
Test system |
L(E)C50 |
Short-term toxicity to fish (OECD 203) |
0.26 mg/L |
Short-term toxicity to Daphnia (OECD 202) |
0.383 mg/L |
Toxicity to algae (OECD 201) |
0.626 mg/L |
Toxicity to duckweed (OECD 221) |
>1.02 mg/L |
Short-term toxicity to Daphnia with humic acid - screening |
>1.90 mg/L |
Lemna gibba represents a member of aquatic plants other than algae and delivers further information on the toxic potential of the compound towards a wider range of organisms. This study revealed EC50 and EC10 values of greater than 1.02 mg/L (measured value) and a NOEC value of 0.17 mg/L. The non-GLP but well documented screening study towards Daphnia magna in the presence of low concentrations of humic acid investigated the effect of the test substance on the immobilization of Daphnia magna according also to OECD guideline 202. Under environmental conditions the compound is present in its cationic form and expected to bind to humic acid, suspended particles and the solid soil phase which reduces its bioavailability and its toxic effects towards aquatic organisms. Therefore, the more realistic approach of a test with low concentrations of humic acid was chosen to have a better approximation of the compound’s environmental behavior and subsequent toxic potential. The M4 test medium used in this study was amended with a low level of humic acid equivalent to 1 mg/L total organic carbon in order to better approximate a natural surface water. The EC50 value was determined to be greater than 1.9 mg/L and the NOEC value as 0.95 mg/L. The mitigating effect of humic acid as demonstrated in the Daphnia magna screening study is critical for a proper assessment of the toxic behavior of the compound in the environment.
In light of the available data an assessment factor of 1000 seems to be overly protective. On the one hand additional information on a further species (Lemna gibba) is available and on the other hand the more realistic behavior of the compound under environmental conditions was investigated. According to ECHA’s Guidance on information requirements and chemical safety assessment, Chapter R.10 the assessment factor can be lowered depending on the available evidence. Both the study on Lemna gibba and the screening study towards Daphnia magna clearly reduce the overall uncertainty in the derivation of the PNEC-aquatic. The study towards Lemna gibba reduces the interspecies variation and the study towards Daphnia magna with humic acid is clear proof that the cationic properties of the compound mitigate the toxic potential. Furthermore, in the available regular OECD 201, 202 and 203 studies the lowest L(E)C 50 was determined in the fish study with a LC50 of 0.26 mg/L. The study was conducted without humic acid. Subsequently, this value was used for the derivation of the PNEC-aquatic and thus represents a worst case condition as the mitigating effect of humic acid and other suspended particles is not even taken into account. Therefore, it was decided to use an assessment factor of 500 for the derivation of the PNEC-aquatic. Against the background of the available data a factor of 500 still seems to be a conservative and protective factor and it still ensures that possible adverse effects are identified in the hazard assessment.Conclusion on classification
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.
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