Registration Dossier

Environmental fate & pathways

Hydrolysis

Currently viewing:

Administrative data

Link to relevant study record(s)

Reference
Endpoint:
hydrolysis
Type of information:
experimental study
Adequacy of study:
key study
Study period:
13 March - 15 May, 2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
Study has been performed according to OECD and/or EU guidelines and according to GLP principles.
Qualifier:
according to
Guideline:
EU Method C.7 (Degradation: Abiotic Degradation: Hydrolysis as a Function of pH)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Radiolabelling:
no
Analytical monitoring:
yes
Details on sampling:
The concentration of the test substance in the test samples was determined immediately after preparation (t=0), after 2.4 hours and after 5 days. The samples taken at t > 0 were cooled to room temperature using running tap water.
Buffers:
Acetate buffer pH 4: solution of 16.6% 0.05 M sodium acetate and 83.4% 0.05 M acetic acid.
Phosphate buffer pH 7: solution of 0.05 M potassium dihydrogenphosphate adjusted to pH 7 using 1 N sodium hydroxide.
Borate buffer pH 9: solution of 0.05 M boric acid and 0.05 M potassium chloride adjusted to pH 9 using 1 N sodium hydroxide.

Details on test conditions:
Test substance solutions were prepared in the buffer solutions at a nominal concentration between 662 - 748 mg/l. The solutions were filter-sterilised through a 0.2 µm membrane filter and transferred into sterile glass vessels. To exclude oxygen, nitrogen gas was purged through the solutions for 5 minutes. Each vessel was sealed and placed in a thermostatically controlled water bath at 50.0°C +/- 0.1°C.

Duration:
5 d
Temp.:
50 °C
Positive controls:
no
Negative controls:
yes
Remarks:
blank buffer solution
Preliminary study:
The result for the samples taken at t=0 hours and t=2.4 hours indicated that there was a spread on the results. Because neither improvement of the method nor development of a more accurate method is possible, it was decided to analyse t=5 days samples in triplicate.
Transformation products:
not measured
% Recovery:
97
pH:
4
Temp.:
50 °C
Duration:
5 d
% Recovery:
108
pH:
7
Temp.:
50 °C
Duration:
5 d
% Recovery:
94
pH:
9
Temp.:
50 °C
Duration:
5 d
pH:
4
Temp.:
25 °C
DT50:
> 1 yr
Key result
pH:
7
Temp.:
25 °C
DT50:
> 1 yr
pH:
9
Temp.:
25 °C
DT50:
> 1 yr
Details on results:
At pH 4, pH 7 and pH 9, a decrease in concentration < 10% was observed after 5 days. It demonstrates that the half-life time of the test substance at 25°C > 1 year which is as expected based on the chemical structure of the test substance. According to the guideline, no further tests were required.
Validity criteria fulfilled:
not applicable
Conclusions:
Ditetrahydrofurylpropane is hydrolytically stable.

Description of key information

A test was conducted according to EU method C.7. At pH 4, pH 7 and pH 9, a decrease in concentration < 10% was observed after 5 days. It demonstrates that the half-life time of the test substance at 25°C > 1 year which is as expected based on the chemical structure of the test substance.

Key value for chemical safety assessment

Additional information

Ditetrahydrofurylpropane is hydrolytically stable at pH 4, 7 and 9. The half-life time at 25°C is > 1 year for pH 4, 7 and 9.