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Diss Factsheets
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EC number: 946-398-8 | 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
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:
- 18 August 2015 to 06 November 2015
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- HPLC method using UV absorbance detection at a wavelength of 280 nm for determination of test material concentration and stability in peanut oil formulations.
- GLP compliance:
- yes
- Test substance stable:
- yes
- Conclusions:
- Formulations prepared at target test substance concentrations of 1 and 220 mg/mL met the protocol-specified requirement for homogeneity and for storage, re-suspension homogeneity and stability after 6 and 12 days storage at room temperature.
- Executive summary:
METHOD
Test item concentration from 1.00 to 220 mg/mL in peanut oil was determined using an HPLC method and UV absorbance at a wavelength of 280 nm. Test item stability was also assessed in a QC stock solutions stored at room temperature for 1 and 6 days, in primary dilutions stored at room temperature for 6 days, and in calibration standards and processed QC samples stored at room temperature for 5 days. Test substance homogeneity was assessed and re-suspension homogeneity and stabilty were assessed after 6 and 12 days of room temperature storage in formulations prepared at target concentrations of 1 and 220 mg/mL test item.
RESULTS
The test material assay procedure was validated in this study with 3 validation sessions. Quantitation was performed using calibration standards ranging in test item concentration from 100 to 500 μg/mL. The mean back-calculated standard concentrations had inter-session variability ranging from 0.16 % to 0.96 % Relative Standard Deviation (RSD) and % Relative Error (RE) ranging from -0.11 % to 0.14 %, which met the protocol-specified acceptance criteria for calibration standards, i.e., RSD ≤10% (≤15% at the lowest concentration) and %RE within ± 10% (± 15% at the lowest concentration). Assay precision and accuracy were verified by the analysis of QC samples prepared at nominal concentrations of 1.00, 40.0, and 220 mg/m test material. The mean calculated QC concentrations had inter-session variability (precision) ranging from 1.8 % to 2.4 % RSD and %RE (accuracy) ranging from -14 % to 0.27 %, which met the protocol-specified acceptance criteria for precision and accuracy, i.e., RSD ≤ 15% and %RE within ± 15%.
The test substance met the protocol-specified acceptance criteria for stability in a QC stock solution stored at room temperature for 1 day, in primary dilutions stored at room temperature for 6 days, and in calibration standards and processed QC samples stored at room temperature for 5 days (post-storage concentration was not < 90 % of the pre-storage value or the theoretical value).
The results of the test substance homogeneity assessment in formulations prepared at target concentrations of 1 and 220 mg/mL test item met the protocol-specified acceptance criteria ((RSD for the mean concentration was ≤ 10 % at a concentration within the acceptable limits of 85 % to 115 % of target).
Assessment of test substance re-suspension homogeneity and stability met the protocol-specified acceptance criteria in formulations prepared at target concentrations of 1 and 220 mg/mL test item and stored at room temperature for 6 and 12 days (RSD for the mean concentration was ≤ 10 % and post-storage concentration was not < 90 % of the pre-storage value or the theoretical value.
CONCLUSION
Formulations prepared at target test substance concentrations of 1 and 220 mg/mL met the protocol-specified requirement for homogeneity and for storage, re-suspension homogeneity and stability after 6 and 12 days storage at room temperature.
Reference
- Under the described chromatographic conditions, the retention time of the test item was approximately 4.8 minutes.
- The total analysis time for each run was 10.0 minutes.
- Assay specificity/selectivity was confirmed when HPLC/UV analysis of processed vehicle samples revealed no significant peaks (with S/N > 10) at or near the retention time for the test item.
- The post-storage test substance concentrations ranged from 95.4 % to 107 % of the pre-storage values.
- For a nominal concentration of 1 mg/mL, mean concentration at time zero was determined to be 0.846 mg/mL (97.8 % of pre-storage value) after 6 days at room temperature.
- For a nominal concentration of 1 mg/mL, mean concentration at time zero was determined to be 0.847 mg/mL (97.9 % of pre-storage value) after 12 days at room temperature.
- For a nominal concentration of 220 mg/mL, mean concentration at time zero was determined to be 253 mg/mL (107 % of pre-storage value) after 6 days at room temperature.
- For a nominal concentration of 220 mg/mL, mean concentration at time zero was determined to be 226 mg/mL (95.4 % of pre-storage value) after 12 days at room temperature.
Description of key information
The post-storage test substance concentrations of formulations prepared at target test substance concentrations of 1 and 220 mg/mL in peanut oil ranged from 95.4 % to 107 % of the pre-storage values. As such, the test item met the protocol-specified requirement for homogeneity and for storage, re-suspension homogeneity and stability after 6 and 12 days storage at room temperature.
Additional information
No additional data.
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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