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Environmental fate & pathways

Hydrolysis

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Administrative data

Endpoint:
hydrolysis
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
No data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Remarks:
This study was not performed according to international guideline and is not GLP. However, this study is well documented and is considered reliable with restrictions.

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
2011
Report Date:
2011

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 111 (Hydrolysis as a Function of pH)
Principles of method if other than guideline:
This study was not performed according to international guideline. The aim of the study is to assess the stability of the substance in a series of simple media simulating perfumery applications. The test media are standard aqueous buffers at pH 2, pH 5, pH 7, pH 8.5 and pH 12 containing 1% of non ionic surfactant. The tests are done in accelerated conditions at 40°C during ca. one month.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified
Radiolabelling:
not specified

Study design

Analytical monitoring:
yes
Estimation method (if used):
Not applicable
Duration of testopen allclose all
Duration:
28 d
pH:
12
Temp.:
40 °C
Initial conc. measured:
> 200 - < 300 other: ppm
Duration:
28 d
pH:
8.5
Temp.:
40 °C
Initial conc. measured:
> 200 - < 300 other: ppm
Duration:
28 d
pH:
7
Temp.:
40 °C
Initial conc. measured:
> 200 - < 300 other: ppm
Duration:
28 d
pH:
5
Temp.:
40 °C
Initial conc. measured:
> 200 - < 300 other: ppm
Duration:
28 d
pH:
2
Temp.:
40 °C
Initial conc. measured:
> 200 - < 300 other: ppm

Results and discussion

Transformation products:
not measured
Total recovery of test substance (in %)open allclose all
% Recovery:
> 90
pH:
2
Temp.:
40 °C
Duration:
28 d
% Recovery:
> 90
pH:
5
Temp.:
40 °C
Duration:
28 d
% Recovery:
> 90
pH:
7
Temp.:
40 °C
Duration:
28 d
% Recovery:
> 90
pH:
8.5
Temp.:
40 °C
Duration:
28 d
% Recovery:
> 90
pH:
12
Temp.:
40 °C
Duration:
28 d

Any other information on results incl. tables

No additional information

Applicant's summary and conclusion

Validity criteria fulfilled:
not applicable
Conclusions:
The disappearance of the parent compound after 5 days as well as after 28d is less than 10% at any pH (from 2 to 12) at 40°C. Therefore, it can be concluded that the substance is hydrolytically stable under the conditions of the test.
Executive summary:

This study was not performed according to international guideline and is not GLP. The aim of the study is to assess the stability of the substance in a series of simple media simulating perfumery applications. The test media are standard aqueous buffers at pH 2, pH 5, pH 7, pH 8.5 and pH 12 containing 1% of non ionic surfactant (Arkopal N 150). The tests are done in accelerated conditions at 40°C during ca. one month. This study is well documented and is considered reliable with restrictions.

200 – 300 ppm of raw material are dissolved in the pH buffer containing the surfactant and put into storage in an oven at 40°C. Small aliquots of the test solution are extracted with an organic solvent (typically cyclohexane or ethyl acetate) containing a hydrocarbon standard (typically C12, C17 or C20) on a regular basis throughout the test (typically at time = 0, 0.25, 1, 2, 4, 7, 15, 21 and 28 days). The extracts are analyzed by GC-FID and the results are plotted as (Area/Area Std) expressed in [%]. The measurement at time = 0 is set at 100% and the succeeding measurements are calculated relatively to the time = 0 measurement. Therefore the curves represent the percentage of product remaining in the test solution at the time of analysis.

The disappearance of the parent compound after 5 days as well as after 28d is less than 10% at any pH (from 2 to 12) at 40°C. Therefore, it can be concluded that the substance is hydrolytically stable under the conditions of the test.