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EC number: 202-956-6 | CAS number: 101-58-6
- 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
Water solubility
Administrative data
Link to relevant study record(s)
- Endpoint:
- water solubility
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Nov. 10, 2020 to Dec. 02, 2020
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- other: SANCO/3029/99 rev. 4 dated 11. Jul. 2000: “Residues: 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”
- Version / remarks:
- 4, dated 11. Jul. 2000
- Qualifier:
- according to guideline
- Guideline:
- other: Guideline on bioanalytical method validation (EMEA/CHMP/EWP/192217/2009 Rev.1 Corr. 2, Committee for Medicinal Products for Human Use (CHMP), adopted 21 July 2011)
- Version / remarks:
- Rev. 1, adopted 21 July 2011
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- flask method
- Key result
- Water solubility:
- < 1 µg/L
- Conc. based on:
- test mat. (dissolved fraction)
- Temp.:
- 20 °C
- pH:
- ca. 6
- Details on results:
- Analytical Method:
The validation of a HPLC-Method for the determination of Bis(4-(1,1,3,3-tetramethylbutyl)phenyl)ether was tested.
The test item was separated with an Agilent Poroshell EC-120 C18, 2.7 µm, 150*4.6 mm column and detected with HPLC-UV.
Validation Results:
Calibrated Range: 1 – 29 µg/L
Quadratic term c: 0.0000058430 mAU*min / (µg/L)2
Linear term / Slope b: 0.0014928 mAU*min / µg/L
Constant / Intercept a: 0.00124864
Method Variation Coefficient (Precision): 2.37 %
Specificity: was given
Solubility in demineralised water < 1 µg/L
Solubility in Algal test medium < 1 µg/L
Solubility in Daphnia test medium < 1 µg/L
Accuracy / Stability in demineralised water: Testing not possible
Accuracy / Stability in Algal test medium: Testing not possible
Accuracy / Stability in Daphnia test medium: Testing not possible - Conclusions:
- A limit test up to the detection limit was carried out during the validation of the analytical method.
No evaluable test item concentration was found. Therefore, the solubility in water is considered as < 1 µg/L at pH ca. 6 and Temp. 16.6-22.2 °C.
According to REACH Regulation (REGULATION (EC) No 1907/2006) Annex VII, COLUMN 2 SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1, 7.7 “If the substance appears ‘insoluble’ in water, a limit test up to the detection limit of the analytical method shall be performed.”
Reference
Solubility
Table: Solubility estimation results
Medium |
Nominal |
Dilution |
Peak |
Concen- |
Mean |
|
[g/L] |
|
[mAU*min] |
[µg/L] |
[µg/L] |
Demineralised |
1 |
2 |
n.d. |
n.c. |
n.c. |
n.d. |
n.c. |
||||
0.00057 |
< LOQ |
||||
n.d. |
n.c. |
n.d. = not detectable
No evaluable test item concentration was found.
All acceptance criteria defined in the validation plan are fulfilled for the calibration range of 1 - 29 µg/L using a quadratic calibration function.
After the injection of the highest calibration level, a solvent blank was injected. As no test item peak area was detectable in the blank, the condition “≤ 20 % of the measured value of the lowest calibration level” was fulfilled. The relative standard deviation of fivefold determination of 11 µg/L calibration level showed an RSD = 2.6 %.
In demineralised water, a peak area of 68 % of the smallest calibration standard was detectable. However, the two replicates after stirring of 2 g/L test item in demineralised water showed no or substantially smaller noise peaks, this was considered uncritical.
The pre-test for solubility of the test item in demineralised water (pH 6.3) indicated that the solubility at 16.6-22.2 °C is substantially lower than 1 µg/L.
Due to the low solubility, testing of accuracy and stability in matrices was not possible.
No observations arousing doubts concerning the accuracy of the results and the validity of the study were made. No deviations were ascertained.
Description of key information
A limit test up to the detection limit was carried out during the validation of the analytical method.
No evaluable test item concentration was found. Therefore, the solubility in water is considered as < 1 µg/L at pH ca. 6 and Temp. ca. 20 °C.
Key value for chemical safety assessment
Additional information
According to REACH Regulation (REGULATION (EC) No 1907/2006) Annex VII, COLUMN 2 SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1, 7.7 “If the substance appears ‘insoluble’ in water, a limit test up to the detection limit of the analytical method shall be performed.”
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.