Registration Dossier

Diss Factsheets

Environmental fate & pathways

Hydrolysis

Currently viewing:

Administrative data

Endpoint:
hydrolysis
Type of information:
experimental study
Adequacy of study:
disregarded due to major methodological deficiencies
Study period:
From 19 to 21 April 2006
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
This study was performed according to EU Method C7 and OECD guideline 111 with GLP statement. This study is not valid, quality criteria were not met: recovery of analysis was lower than 70% (mean recovery: 66.6% at pH 4, 65% at pH 7 and 81.7% at pH 9). This study is technically not feasible.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report date:
2006

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 111 (Hydrolysis as a Function of pH)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method C.7 (Degradation: Abiotic Degradation: Hydrolysis as a Function of pH)
Deviations:
no
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes (incl. QA statement)
Remarks:
30th August 2005

Test material

Constituent 1
Chemical structure
Reference substance name:
(3S)-3-(dodecylthio)-1-[(1S,2R)-2,6,6-trimethyl-3-cyclohexen-1-yl]-1-butanone
Molecular formula:
C25 H46 O S
IUPAC Name:
(3S)-3-(dodecylthio)-1-[(1S,2R)-2,6,6-trimethyl-3-cyclohexen-1-yl]-1-butanone
Constituent 2
Chemical structure
Reference substance name:
(3R)-3-(dodecylthio)-1-[(1S,2R)-2,6,6-trimethyl-3-cyclohexen-1-yl]-1-butanone
Molecular formula:
C25 H46 O S
IUPAC Name:
(3R)-3-(dodecylthio)-1-[(1S,2R)-2,6,6-trimethyl-3-cyclohexen-1-yl]-1-butanone
Constituent 3
Chemical structure
Reference substance name:
(3S)-3-(dodecylthio)-1-[(1R,2S)-2,6,6-trimethyl-3-cyclohexen-1-yl]-1-butanone
Molecular formula:
C25 H46 O S
IUPAC Name:
(3S)-3-(dodecylthio)-1-[(1R,2S)-2,6,6-trimethyl-3-cyclohexen-1-yl]-1-butanone
Constituent 4
Chemical structure
Reference substance name:
(3R)-3-(dodecylthio)-1-[(1R,2S)-2,6,6-trimethyl-3-cyclohexen-1-yl]-1-butanone
Molecular formula:
C25 H46 O S
IUPAC Name:
(3R)-3-(dodecylthio)-1-[(1R,2S)-2,6,6-trimethyl-3-cyclohexen-1-yl]-1-butanone
Test material form:
liquid
Details on test material:
- Physical state: colourless to pale yellow slightly viscous liquid
Specific details on test material used for the study:
- Storage condition of test material: Approximately 4 °C under nitrogen in the dark
Radiolabelling:
no

Study design

Analytical monitoring:
yes
Estimation method (if used):
The concentration of the sample solutions (g/L) was calculated using the equation below:

C.spl = (P.spl/P.std) * C.std * D * (1/1000)

Where:
C.spl = sample concentration (g/L)
P.spl = mean peak area of sample solution
P.std = mean peak area of standard solution, corrected to nominal standard concentration
C.std = nominal standard concentration (3.0 mg/L)
D = sample dilution factor (0.0125)
Duration of testopen allclose all
Duration:
144 h
pH:
4
Initial conc. measured:
0.043 mg/L
Duration:
168 h
pH:
7
Initial conc. measured:
0.052 mg/L
Duration:
120 h
pH:
9
Initial conc. measured:
0.038 mg/L

Results and discussion

Transformation products:
not measured
Total recovery of test substance (in %)open allclose all
% Recovery:
66.6
pH:
4
Temp.:
50 °C
% Recovery:
65
pH:
7
Temp.:
50 °C
% Recovery:
81.7
pH:
9
Temp.:
50 °C
Dissipation DT50 of parent compoundopen allclose all
Key result
pH:
4
Temp.:
25 °C
DT50:
> 1 yr
Type:
not specified
Remarks on result:
other: estimation
Key result
pH:
7
Temp.:
25 °C
DT50:
> 1 yr
Type:
not specified
Remarks on result:
other: estimation
Key result
pH:
9
Temp.:
25 °C
DT50:
> 1 yr
Type:
not specified
Remarks on result:
other: estimation

Any other information on results incl. tables

See the mean peak area relating to the standard and samples solutions, in "attached background material".

Applicant's summary and conclusion

Validity criteria fulfilled:
no
Conclusions:
Invalid study. The half-life at 25°C was estimated > 1 year at pH 4, 7 and 9.
Executive summary:

Assessment of hydrolytic stability of the test item was carried out using Method C7 of Commission Directive 92/69/EEC and Method 111 of the OECD Guidelines for testing of chemicals, 13 April 2004.

The results are as follows:

pH 4: estimated half-life at 25°C > 1 year.

pH 7: estimated half-life at 25°C > 1 year.

pH 9: estimated half-life at 25°C > 1 year.

This study is not valid, quality criteria were not met: recovery of analysis was lower than 70% (mean recovery: 66.6% at pH 4, 65% at pH 7 and 81.7% at pH 9). This study is technically not feasible.

Categories Display