Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2009
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Testing was performed according to guideline. Restriction due to water solubility being estimated by visual inspection because insolubles could not be removed.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report date:
2009

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method A.6 (Water Solubility)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of method:
flask method

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction products of fatty acids, C18-unsatd., dimers, partly hydrogenated with N,N-dimethyl-1,3-propanediamine
EC Number:
937-688-5
Cas Number:
1391530-05-4
Molecular formula:
C46H82N4O2 to C46H94N4O2
IUPAC Name:
Reaction products of fatty acids, C18-unsatd., dimers, partly hydrogenated with N,N-dimethyl-1,3-propanediamine

Results and discussion

Water solubility
Water solubility:
< 0.9 mg/L
Temp.:
20 °C
Remarks on result:
other: pH not reported

Any other information on results incl. tables

Table 1: Estimate of Water Solubility by Shake Flask Method

Test Sample

 Substance (g )/  Volume Water (ml)

Observations

Estimated Water Solubility (mg/L)

1

0.0152 g/1000 mL

Insoluble material before centrifugation/ filtration

< 15.2

Insoluble material after centrifugation/ filtration

< 15.2

2

0.0009 g/1000 mL

 

Insoluble test material

< 0.9

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): slightly soluble (0.1-100 mg/L)
The test substance is slightly soluble. Water solubility is estimated to be < 0.9 mg/L at 20 deg. C
Executive summary:

The water solubility was determined by the shake flask method. In a preliminary test, it was found that suspended, water insoluble material could not be removed either by filtration or centrifugation to provide a suitable sample for analysis. As a result, the water solubility was visually estimated. At a nominal concentration of 0.9 mg/L, undissolved test material was observed indicating the water solubility of the test substance is < 0.9 mg/L at 20 deg. C.