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Diss Factsheets
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EC number: 813-811-7 | CAS number: 253265-97-3
- 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
Stability in organic solvents and identity of relevant degradation products
Administrative data
Link to relevant study record(s)
- Endpoint:
- stability in organic solvents and identity of relevant degradation products
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 2018-09-06 to 2019-02-07
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- other: European Commission: Guidance for Generating and Reporting Methods of Analysis in Support of Pre-registration Data Requirements for Annex II (Part A, section 4) and Annex III (Part A, section 5) of Directive 91/414, SANCO/3029/99 rev. 4 (11/07/00)
- Deviations:
- yes
- Remarks:
- The mean RF of the calibration curve during formulation analyses vs validation had a relative difference of 26.78%. This may be caused by the instrument configuration. As a calibration curve is used for quantification this does not impact results.
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- - Batch n°: I16FD3167
- Analytical purity: 98.2%
- Expiration date: 26 October 2018 (retest date)
- Storage condition: In refrigerator (2-8°C) - Test substance stable:
- yes
- Transformation products:
- no
- Conclusions:
- Trial formulations (not used for dosing) were prepared in vehicle (acetonitrile) at 1 mg/mL (low), 10 mg/mL (mid) and 200 mg/mL (high) and analysed to determine the accuracy and stability of the test item in formulations:
The concentrations analysed in the formulation at mid and high target level were in agreement with target concentrations. The mean accuracy of the formulation at low target level was just below the criteria (i.e. 83.61%).
Formulations at the entire range were stable when stored at room temperature under normal laboratory light conditions for at least 6 hours.
Formulations at mid and high target level were stable when stored in the refrigerator for 14 days. Formulations at low target level were not stable for 14 days in the refrigerator.
Reference
Accuracy of preparation : The concentrations analysed in the formulations at 10 mg/mL (mid) and 200 mg/mL (high) were in agreement with target concentrations (i.e. mean accuracies between 85.00% and 115.00%).The concentrations analysed in the formulations at 1 mg/mL (low) were slightly below the criterion (i.e. mean accuracy of 83.61%).
Stability: Analysis of the formulations at 1 mg/mL (low), 10 mg/L (mid) and 200 mg/mL (high) after storage yielded a relative difference of ≤ 10.00% when stored at room temperature under normal laboratory light conditions for at least 6 hours. Based on this, the formulations were found to be stable during storage at room temperature under normal laboratory light conditions for at least 6 hours. When stored in the refrigerator for 14 days the relative difference of the formulation at 1 mg/mL was -14.49%. The relative difference of the formulation at 10 and 200 mg/mL was ≤ 10.00%.
Stability test at room temperature under normal laboratory light conditions for 6 hours
Group | Date of analysis | Analysed conc [mg/mL]- t=0 [1] | Analysed conc [mg/mL] - t=6h | Relative difference [%] |
Low | 25 Sep 2018 | 0.836 | 0.842 [2] | 0.75 |
Mid | 25 Sep 2018 | 8.93 | 9.13 [3] | 2.63 |
High | 25 Sep 2018 | 205 | 200 [4] | -2.35 |
[1] Mean of six samples at t=0 taken at 10%, 50% and 90% height.
[2] Mean of two samples at t=6 hours taken at 50% height. Individual results were 0.823 and 0.861 mg/mL.
[3] Mean of two samples at t=6 hours taken at 50% height. Individual results were 8.77 and 9.56 mg/mL.
[4] Mean of two samples at t=6 hours taken at 50% height. Individual results were 206 and 195 mg/mL.
Stability test for 14 days in the refrigerator
Group | Date of analysis | Analysed conc [mg/mL]- t=0 [1] | Analysed conc [mg/mL] - t=6h | Relative difference [%] |
Low | 09 Oct 2018 | 0.836 | 0.715 [2] | -14.49 |
Mid | 09 Oct 2018 | 8.93 | 8.11 [3] | -9.18 |
High | 09 Oct 2018 | 205 | 203 [4] | -0.90 |
[1] Mean of six samples at t=0 taken at 10%, 50% and 90% height.
[2] Mean of two samples at t=6 hours taken at 50% height. Individual results were 0.743 and 0.687 mg/mL.
[3] Mean of two samples at t=6 hours taken at 50% height. Individual results were 8.85 and 7.37 mg/mL.
[4] Mean of two samples at t=6 hours taken at 50% height. Individual results were 201 and 205 mg/mL.
Description of key information
Formulations (prepared in acetonitrile) at the entire range were stable when stored at room temperature under normal laboratory light conditions for at least 6 hours.
Formulations at mid and high target level were stable when stored in the refrigerator for 14 days. Formulations at low target level were not stable for 14 days in the refrigerator.
Additional information
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.