Registration Dossier

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:
2016
Report Date:
2016

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
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:
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:
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. certificate)
Remarks:
Hess. Ministerium für Umwelt, Energie, Landwirtschaft und Verbraucherschutz, Mainzer Straße 80, D65189 Wiesbaden, Germany
Type of method:
flask method

Test material

Reference
Name:
Unnamed
Type:
Constituent
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

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