Registration Dossier

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2018-10-11
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report date:
2018

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EU Method A.6 (Water Solubility)
Qualifier:
according to guideline
Guideline:
OECD Guideline 105 (Water Solubility)
GLP compliance:
yes (incl. QA statement)
Type of method:
flask method

Test material

Constituent 1
Reference substance name:
Fatty acids, C14-18 and C16-18-unsatd., ammonium salts
EC Number:
271-685-3
EC Name:
Fatty acids, C14-18 and C16-18-unsatd., ammonium salts
Cas Number:
68604-33-1
Molecular formula:
C14H28O2.H3N / C16H32O2.H3N / C18H36O2.H3N / C18H34O2.H3N / C18H32O2.H3N / C18H30O2.H3N / C16H30O2.H3N .
IUPAC Name:
Fatty acids, C14-18 and C16-18-unsatd., ammonium salts
Test material form:
other: paste-like
Details on test material:
Test Substance Name: Fatty acids, C14-18 and C16-18-unsatd., ammonium salts.
Product Name/Synonym: Ammonium Oleate.
CAS number: 68604-33-1.
EG number: 271-685-3.
Batch Number: 2017-30 2022-30 04.
Purity of this sample/batch: 85.3% (contains 14.7% water).
Description: Yellow-brown paste.
Expiry date: KW30 2022 (July 2022).

Results and discussion

Water solubility
Water solubility:
< 0.001 g/L
Conc. based on:
test mat.
Temp.:
20 °C
Remarks on result:
other: No data on pH value was provided. pH-value see 4.20.

Any other information on results incl. tables

Preliminary estimation:

Mass of sample (mg) Volume of water in which sample dissolves (ml) Estimated solubility (g.L-1 ) Analysis method
1 1001 < 0.01 N/A

Estimated Water Solubility (g.L-1): < 0.001.

Analysis Apparatus, Method and Test Conditions:

Temperature of determination (°C) : 20 ; pH of water : 7.08 .

Comment: For the preliminary estimation the majority of the 1 mg of sample did not dissolve in water after shaking and sonication for 30 minutes. Therefore it is expected that the solubility of the sample is below the limit of detection on the HPLC system.

Applicant's summary and conclusion

Conclusions:
The test subtance Fatty Acids, C14-C18 and C16-18-unsatd., ammonium salts is difficult to dissolve or insoluble in water (Water Solubility (20°C): <1 mg/L).
Executive summary:

Water Solubility of Fatty Acids, C14-C18 and C16-18-unsatd., ammonium salts at 20°C is <1 mg/L.