Registration Dossier

Administrative data

Endpoint:
hydrolysis
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The data used is considered reliable as it is taken from a study that has followed a recognised guideline and was conducted to GLP standards.

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 111 (Hydrolysis as a Function of pH)
Qualifier:
according to guideline
Guideline:
EU Method C.7 (Degradation: Abiotic Degradation: Hydrolysis as a Function of pH)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Reference substance name:
tert-butanol
IUPAC Name:
tert-butanol
Constituent 2
Chemical structure
Reference substance name:
2-methylpropan-2-ol
EC Number:
200-889-7
EC Name:
2-methylpropan-2-ol
Cas Number:
75-65-0
Molecular formula:
C4H10O
IUPAC Name:
2-methylpropan-2-ol
Constituent 3
Reference substance name:
tertiary butyl alcohol
IUPAC Name:
tertiary butyl alcohol

Study design

Details on sampling:
Duplicate samples were taken from test vessels at 0, 24 and 120 hours
Buffers:
- pH: 4
- Type and final molarity of buffer: 0.005 mol/L potassium hydrogen phthalate

- pH: 7
- Type and final molarity of buffer: 0.003 mol/L disodium hydrogen orthophosphate, 0.002 mol/L potassium dihydrogen orthophosphate, 0.002 mol/L sodium chloride

- pH: 9
- Type and final molarity of buffer: 0.001 mol/L disodium tetraborate, 0.002 mol/L sodium chloride
Details on test conditions:
The buffer solutions were filtered through a 0.2 um membrane filter to ensure they were sterile. Solutions were subjected to ultrasonication and degassing with nitrogen to minimise dissolved oxygen content.

Stock solutions were prepared at 0.4 g/L in the three buffer solutions
Duration of testopen allclose all
Duration:
120 h
pH:
4
Temp.:
50 °C
Initial conc. measured:
0.374 g/L
Duration:
120 h
pH:
7
Temp.:
50 °C
Initial conc. measured:
0.372 g/L
Duration:
120 h
pH:
9
Temp.:
50 °C
Initial conc. measured:
0.363 g/L
Number of replicates:
2
Positive controls:
no
Negative controls:
no

Results and discussion

Preliminary study:
Less than 10% hydrolysis seen at all 3 test pH values over 5 days at 50C. Equivalent to an environmental half-life of greater than 1 year, and indicating no need for conduct of the full test.
Transformation products:
no
Details on hydrolysis and appearance of transformation product(s):
No hydrolysis observed
Total recovery of test substance (in %)open allclose all
% Recovery:
> 98.3 - < 106
pH:
4
Temp.:
50 °C
Duration:
5 d
Remarks on result:
other: No hydrolysis observed
% Recovery:
> 96.9 - < 107
pH:
7
Temp.:
50 °C
Duration:
5 d
Remarks on result:
other: No hydrolysis observed
% Recovery:
> 99.5 - < 106
pH:
9
Temp.:
50 °C
Duration:
5 d
Remarks on result:
other: No hydrolysis observed
Dissipation DT50 of parent compound
Remarks on result:
other: No hydrolysis observed
Details on results:
No hydrolysis observed

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
Less than 10% hydrolysis seen at all 3 test pH values over 5 days at 50C. Equivalent to an environmental half-life of greater than 1 year, and indicating no need for conduct of the full test.
Executive summary:

Less than 10% hydrolysis seen at all 3 test pH values over 5 days at 50C. Equivalent to an environmental half-life of greater than 1 year, and indicating no need for conduct of the full test.