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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 605-708-9 | CAS number: 174125-93-0
- 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
Toxicity to microorganisms
Administrative data
- Endpoint:
- activated sludge respiration inhibition testing
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study does not need to be conducted because the substance is highly insoluble in water, hence indicating that aquatic toxicity is unlikely to occur
- Justification for type of information:
- JUSTIFICATION FOR DATA WAIVING
According to REACH Annex VIII column 2, 9.1.4. Activated sludge respiration inhibition testing, the study does not need to be conducted if:
— there is no emission to a sewage treatment plant, or
— there are mitigating factors indicating that microbial toxicity is unlikely to occur, for instance the substance is highly insoluble in water, or
— the substance is found to be readily biodegradable and the applied test concentrations are in the range of concentrations that can be expected in the influent of a sewage treatment plant.
In general, there is no legal limit value available defining a substance as poorly water soluble or insoluble under REACH. However, in ECHA’s Guidance document Chapter R.7b: Endpoint specific guidance Version 3.0 – February 2016, it is stated: „poorly water soluble substances (e.g. water solubility below 1 mg/L or below the detection limit of the analytical method of the test substance)“. Further, poorly soluble substances are defined by OECD (2000 OECD SERIES ON TESTING AND ASSESSMENT, Number 23, GUIDANCE DOCUMENT ON AQUATIC TOXICITY TESTING OF DIFFICULT SUBSTANCES AND MIXTURES, ENV/JM/MONO(2000)6) as substances with a limit of solubility <100 mg/l although technical problems are more likely to occur at <1mg/l as defined in TGD (1996). Very low water solubility (i.e. in the low μg/l range) could be used as a reason to significantly modify a standard test or to test non-pelagic organisms preferentially.
ECHA’s Guidance document Chapter R.7c: Endpoint specific guidance Version 3.0 – June 2017 further says: „As indicated in the OECD TG 305, for strongly hydrophobic substances (log Kow > 5 and a water solubility below ~ 0.01-0.1 mg/L), testing via aqueous exposure may become increasingly difficult. However, an aqueous exposure test is preferred for substances that have a high log Kow but still appreciable water solubility with respect to the sensitivity of available analytical techniques, and for which the maintenance of the aqueous concentration as well as the analysis of these concentrations do not pose any constraints.
The logPow was determined to be >7.2, and the water solubility is < 4.5 µg/L, so the criteria mentioned above are met. Further, the criterion for “below the detection limit of the analytical method of the test substance” is also met, although actually not relevant for a study acc. e.g. OECD 209.
Based on the available information it can be stated that, as outlined in the second waiving possibility under REACH, the substance is highly insoluble in water. Further, the present endpoint is not relevant for classification and labelling, so the hazard cannot be underestimated.
Hence, an additional study of the toxicity of the registered substance to microorganisms does not need to be conducted, as it is considered both not technically feasible and no additional information on classification and labelling could be retrieved, and the study can be omitted.
Cross-reference
- Reason / purpose for cross-reference:
- data waiving: supporting information
- Remarks:
- water solubility
Reference
- Endpoint:
- water solubility
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2017-05-11 - 2017-10-19 (experimental phase)
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Reason / purpose for cross-reference:
- reference to same study
- Remarks:
- Partition coefficient
- Reason / purpose for cross-reference:
- reference to same study
- Remarks:
- Adsorption / Desorption
- Qualifier:
- according to guideline
- Guideline:
- EU Method A.6 (Water Solubility)
- Version / remarks:
- EC Guideline A.6. Water Solubility. March 19, 2014
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 105 (Water Solubility)
- Version / remarks:
- OECD Guideline 105. Water Solubility. July 27, 1995
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 830.7840 (Water Solubility)
- Version / remarks:
- EPA Product Properties Test Guideline OPPTS 830.7840: Water Solubility: Column Elution Method; Shake Flask Method. March 1998
- Deviations:
- no
- GLP compliance:
- yes
- Type of method:
- flask method
- Remarks:
- slow-stirring
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: sponsor
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: In refrigerator (2-8°C) - Key result
- Water solubility:
- < 0 g/L
- Conc. based on:
- test mat.
- Loading of aqueous phase:
- 10 other: µl/l
- Incubation duration:
- >= 24 - <= 72 h
- pH:
- >= 7.3 - <= 7.4
- Remarks on result:
- other: water solubility is below the LOQ
- Conclusions:
- The study was performed according to OECD TG 105 under GLP on the substance to be registered itself, the test procedure is well documented and therefore reliability of Klimisch 1 has been assigned. The analytical method was properly established. The limit of quantification (LOQ) was assessed at a test item concentration of 10 µg/L in water. The response of the test samples was lower than the response of the lowest calibration solution (0.450 µg/L). The analyzed concentration in the test samples was determined to be < 4.5 µg/L taking a dilution factor of 10 into account. In conclusion it can only be stated that the water solubility of the test item at 20°C was < 4.5 * 10E-6 g/L, making a quantification in e.g. ecotoxicity test impossible as the test item must be regarded as practically insoluble in water.
- Executive summary:
The water solubility of the test item was determined according to EC A.6, OECD 105, and OPPTS 830.7840 under GLP at 20°C by the slow-stirring flask method as < 4.5 x 10E-6 g/L.
Data source
Materials and methods
Results and discussion
Applicant's summary and conclusion
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.