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Water solubility
Administrative data
- Endpoint:
- water solubility
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2016-06-09 - 2016-06-16 (experimental phase)
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 105 (Water Solubility)
- Version / remarks:
- OECD Guidelines for Testing of Chemicals, Guideline No.105, ”Water Solubility”; adopted July 27, 1995
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method A.6 (Water Solubility)
- Version / remarks:
- Commission Regulation (EC) No 440/2008, Annex, Part A, Methods for the determination of physico-chemicals properties, A6 "Water Solubility", May 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 830.7840 (Water Solubility)
- Version / remarks:
- Product Properties Test Guideline of the United States Environment Protection Agency (EPA), OPPTS 830.7840 Water Solubility: Column Elution Method; Shake Flask Method, March 1998
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Hess. Ministerium für Umwelt, Energie, Landwirtschaft und Verbraucherschutz, Mainzer Straße 80, D65189 Wiesbaden, Germany
- Type of method:
- flask method
Test material
- Reference substance name:
- Fatty acids, C16-18 (even numbered), reaction products with tetraethylenepentamine
- Molecular formula:
- not applicable (UVCB substance)
- IUPAC Name:
- Fatty acids, C16-18 (even numbered), reaction products with tetraethylenepentamine
- Test material form:
- other: solid
- Details on test material:
- - Substance type: pure substance
- Storage condition of test material: At room temperature (20 °C ± 5 °C) in the dark
Constituent 1
Results and discussion
Water solubility
- Key result
- Water solubility:
- 99.6 mg/L
- Conc. based on:
- test mat.
- Incubation duration:
- >= 24 - <= 72 h
- Temp.:
- 20 °C
- pH:
- 5
- Remarks on result:
- other:
- Remarks:
- The results showed no tendency to increase, but they differed more than 15 %. Mean value: 99.6 mg/L, Maximum value: 124.8 mg/L, Range: 79 mg/L to 125 mg/L
- Details on results:
- The water solubility was determined using the shake flask method followed up by determination of TOC content as sum parameter, because no specific analytical method was available.
The results showed no tendency to increase, but they differed more than 15 %.
Corresponding to the analyses the water solubility was determined to be at 20 °C:
Mean value: 99.6 mg/L
Maximum value: 124.8 mg/L
Range: 79 mg/L to 125 mg/L
Applicant's summary and conclusion
- Conclusions:
- Water solubility was conducted in a GLP OECD TG 105 study without deviations on the registered substance itself. The shake flask method is a suitable method, also, analysis of test item concentrations in the test samples was done by determination of TOC content as sum parameter, which is also a suitable approach when no specific analytical method was available, and the composition of the test item is known. Hence, there is no indication given that the results are not reliable.
Corresponding to the analyses the water solubility was determined to be at 20 °C:
Mean value: 99.6 mg/L
Maximum value: 124.8 mg/L
Range: 79 mg/L to 125 mg/L
The substance should be hence considered as sparingly soluble. - Executive summary:
The water solubility of Octadecanoic acid, reaction products with tetraethylenepentamine was determined according to OECD TG 105 under GLP using the shake flask method followed up by determination of TOC content as sum parameter, because no specific analytical method was available.
The results showed no tendency to increase, but they differed more than 15 %.
Corresponding to the analyses the water solubility was determined to be at 20 °C:
Mean value: 99.6 mg/L
Maximum value: 124.8 mg/L
Range:79 mg/L to 125 mg/L
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