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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
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EC number: 406-040-9 | CAS number: 125643-61-0
- 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:
- 0.03 mg/L
- PNEC freshwater (intermittent releases):
- 0.03 mg/L
Marine water
- Hazard assessment conclusion:
- PNEC aqua (marine water)
- PNEC value:
- 0.03 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:
- 60.9 mg/kg sediment dw
- Extrapolation method:
- equilibrium partitioning method
Sediment (marine water)
- Hazard assessment conclusion:
- PNEC sediment (marine water)
- PNEC value:
- 0.609 mg/kg sediment dw
- Extrapolation method:
- equilibrium partitioning method
Hazard for air
Hazard for terrestrial organisms
Soil
- Hazard assessment conclusion:
- PNEC soil
- PNEC value:
- 0.05 mg/kg soil dw
- Extrapolation method:
- sensitivity distribution
Hazard for predators
Secondary poisoning
- Hazard assessment conclusion:
- PNEC oral
- PNEC value:
- 6.67 mg/kg food
- Assessment factor:
- 300
Additional information
The environmental studies conducted on the substance have all been ranked reliability 1 according to the Klimish et al system. This ranking was deemed appropriate because the studies were conducted to GLP and in compliance with agreed protocols. The majority of the information has been provided from a migrated NONS file referring to studies, which are more than 12 years old, with the permission of ECHA. Sufficient dose ranges and numbers are detailed; hence it is appropriate for use based on reliability and animal welfare grounds.
General discussion
The acute toxicity study in both Fish and Daphnia produced no adverse results, with LC50 and NOEC values presented as limits at >1000 mg/L. Although no study details where provided as the data was provided by ECHA in a migrated NONS file, it is considered that these values are presumably based on Water Accomodated Fractions (WAFS). The algae study conducted yielded both anNOEC (72 h) and EC50 (72 h) of > 3 mg/L. As such, it should be noted that the substance did not demonstrate any toxic effects at the limit of solubility in water. The values presented for PNEC are as derived using guidance document “R10 - Characterisation of dose [concentration] - response for environment”. However, as no effects were noted at the limit of solubility, a more accurate PNEC can be construed to be the soluble limit; i.e. 0.03 mg/L. Review of the guidance indicates that in sectionR.10.2.2.2 (Q)SAR and grouping approaches, QSAR can be used to provide additional supporting evidence of toxicity. Within the guidance, Table R.10-20 : Overview of programs for prediction of aquatic toxicity tools such as ECOSAR (U.S. EPA 1994) can be used to perform assessment. An assessment of the substance using this QSAR system indicated that no effects at saturation are predicted for these endpoints.
As the guidance for deriving the PNEC for does not provide assessment factors for substances with no effects at the limit of solubility, the assessment factors as proposed have been applied.
The results given shows no toxic effect at saturation, the EC50 and LOEC values are higher than the solubility level of the test item in the test medium. No classification and labelling is applicable for acute aquatic effects. Classification is applied for chronic aquatic effects asAquatic Chronic 4 on the basis of the intrinsic properties noted for the substance.
Conclusion on classification
The results triggered no classification under the Dangerous Substance Directive (67/548/EEC) and the CLP Regulation (EC No 1272/2008). No classification for acute environmental effects is therefore required.
The CLP Regulation (EC No 1272/2008) states that Aquatic Chronic 4 is applicable to substances in:
Cases when data do not allow classification under the above criteria but there are nevertheless some grounds for concern. This includes, for example, poorly soluble substances for which no acute toxicity is recorded at levels up to the water solubility (note 3), and which are not rapidly degradable and have an experimentally determined BCF≥500 (or, if absent, a log Kow≥4), indicating a potential to bioaccumulate, will be classified in this category unless other scientific evidence exists showing classification to be unnecessary. Such evidence includes chronic toxicity NOECs > water solubility or > 1 mg/l, or evidence of rapid degradation in the environment.
The substance fulfills this criteria in that no scientific data apart from QSAR exists to dispute the bioaccumulation potential assigned to the substance. As such, the registrant accepts the current classification as listed in Annex VI to Regulation (EC) No 1272/2008; index reference 607-530-00-7 which is as follows:
CLP Regulation (EC No 1272/2008):Aquatic Chronic 4; H413: May cause long lasting harmful effects to aquatic life.
Dangerous Substance Directive (67/548/EEC):R53 May cause long-term adverse effects in the aquatic environment.
General discussion
The acute toxicity study in both Fish and Daphnia produced no adverse results, with LC50 and NOEC values presented as limits at >1000 mg/L. Although no study details where provided as the data was provided by ECHA in a migrated NONS file, it is considered that these values are presumably based on Water Accomodated Fractions (WAFS). The algae study conducted yielded both anNOEC (72 h) and EC50 (72 h) of > 3 mg/L. As such, it should be noted that the substance did not demonstrate any toxic effects at the limit of solubility in water. The values presented for PNEC are as derived using guidance document “R10 - Characterisation of dose [concentration] - response for environment”. However, as no effects were noted at the limit of solubility, a more accurate PNEC can be construed to be the soluble limit; i.e. 0.03 mg/L. Review of the guidance indicates that in sectionR.10.2.2.2 (Q)SAR and grouping approaches, QSAR can be used to provide additional supporting evidence of toxicity. Within the guidance, Table R.10-20 : Overview of programs for prediction of aquatic toxicitytools such as ECOSAR (U.S. EPA 1994) can be used to perform assessment. An assessment of the substance using this QSAR system indicated that no effects at saturation are predicted for these endpoints.
As the guidance for deriving the PNEC for does not provide assessment factors for substances with no effects at the limit of solubility, the assessment factors as proposed have been applied.
The results given shows no toxic effect at saturation, the EC50 and LOEC values are higher than the solubility level of the test item in the test medium. No classification and labelling is applicable for acute aquatic effects. Classification is applied for chronic aquatic effects asAquatic Chronic 4 on the basis of the intrinsic properties noted for the substance.
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.