Registration Dossier

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
03 Sept - 29 Oct 2010
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study, non-GLP

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
2011
Report Date:
2011
Reference Type:
other: reanalysis of data
Title:
Unnamed
Year:
2018
Report Date:
2018

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 105 (Water Solubility)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method A.6 (Water Solubility)
Deviations:
no
GLP compliance:
no
Type of method:
flask method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Name of test material (as cited in study report): TFEE-5
- Physical state: Colorless liquid
- Analytical purity: 97.21%
- Stability under test conditions: Test item stable
- Storage condition of test material: Ambient temperature, 10-30 °C

Results and discussion

Water solubility
Water solubility:
>= 0.26 - <= 0.29 mg/L
Conc. based on:
test mat.
Loading of aqueous phase:
10 g/L
Incubation duration:
>= 4 - <= 11 d
Temp.:
25 °C
pH:
>= 6.9 - <= 7.1
Details on results:
Solubility reported as 0.3 mg/L

Any other information on results incl. tables

Concentrations were measured in duplicate at three time points. Results are indicated below:

22 hrs 0.16 ± 0.014 mg/L, pH 6.9

4 days 0.26 ± 0 mg/L, pH 7.1

11 days 0.29 ± 0.057 mg/L, pH 6.9

The concentrations on days 4 and 11 were not significantly different (< 15%), establishing that the samples had come to equilibrium.

Applicant's summary and conclusion

Conclusions:
The water solubility of TFEE-5 at 25 °C, pH 7 is 0.3 mg/L (OECD 105)
Executive summary:

The water solubility of TFEE was determined according to EC No. 440/2008, A.6 and OECD TG105. Two grams of TFEE-5 were stirred at 30 °C for 24 hours followed by equilibration at 25 °C for up to 11 days. Concentration in the water phase was not significantly different between days 4 and 11. The water solubility of TFEE-5 at 25 °C, pH 7 is 0.3 mg/L.

The test followed internationally accepted guidelines but was not conducted under GLP or equivalent criteria. Therefore, this study is classified as reliable with restrictions.