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Environmental fate & pathways

Hydrolysis

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Endpoint:
hydrolysis
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
The registered substance contains no organic functional groups that may hydrolyze under environmental condition like alkyl halides, amides, amines, epoxides, esters. The test substance consists only of organic functional groups that are relatively or completely inert with respect of hydrolysis. Based on the chemical structure an estimation of the hydrolysis rate is not possible. In addition, one hydrolysis study performed according to OECD Guideline 111 but without GLP statement was performed on the registered substance showing that the substance is hydrolytically stable at environmentally relevant pH. In conclusion, a GLP study is scientifically unjustified.
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:
guideline study with acceptable restrictions
Remarks:
This study was not performed according to GLP. However, this study is well documented and is considered reliable with restrictions.
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 111 (Hydrolysis as a Function of pH)
Deviations:
no
Principles of method if other than 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
Radiolabelling:
no
Analytical monitoring:
yes
Details on sampling:
200 – 300 ppm of raw material are dissolved in the pH buffer containing the surfactant (Arkopal N 150) 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.
Buffers:
Buffer solutions:
pH 2 (± 0.1) buffer: Reference Handbook of Chemistry and Physics buffer type A
pH 5 (± 0.1) buffer: Reference Handbook of Chemistry and Physics buffer type C
pH 7 (± 0.1) buffer: Reference Handbook of Chemistry and Physics buffer type D
pH 8.5 (± 0.1) buffer: Reference Handbook of Chemistry and Physics buffer type F
pH 12 (± 0.1) buffer: Reference Handbook of Chemistry and Physics buffer type I
Estimation method (if used):
Not applicable
Details on test conditions:
None
Duration:
28 d
Temp.:
40 °C
Initial conc. measured:
200 - 300 other: ppm
Number of replicates:
1
Positive controls:
no
Negative controls:
no
Statistical methods:
None
Preliminary study:
None
Test performance:
No data
Transformation products:
no
Details on hydrolysis and appearance of transformation product(s):
Results showed that the disappearance of the parent compound after 5 days at 40 °C and at environmentally relevant pH is between 10 and 20 % and around 50 % at pH 12.
% Recovery:
80 - 90
pH:
2
Temp.:
40 °C
Duration:
5 d
% Recovery:
80 - 90
pH:
5
Temp.:
40 °C
Duration:
5 d
% Recovery:
80 - 90
pH:
7
Temp.:
40 °C
Duration:
5 d
% Recovery:
80 - 90
pH:
8.5
Temp.:
40 °C
Duration:
5 d
% Recovery:
50
pH:
12
Temp.:
40 °C
Duration:
5 d
Other kinetic parameters:
None
Details on results:
None

None

Validity criteria fulfilled:
not applicable
Conclusions:
The disappearance of the parent compound after 5 days at 40 °C and at environmentally relevant pH is between10 and 20 % and around 50 % at pH 12. Therefore, it can be concluded that the substance is hydrolytically stable under the conditions of the test.
Executive summary:

The aim of this hydrolysis 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.

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 at 40 °C and at environmentally relevant pH is between10 and 20 % and around 50 % at pH 12. Therefore, it can be concluded that the substance is hydrolytically stable under the conditions of the test.

Description of key information

A GLP study is scientifically unjustified.

Key value for chemical safety assessment

Additional information

The registered substance contains no organic functional groups that may hydrolyze under environmental condition like alkyl halides, amides, amines, epoxides, esters. The test substance consists only of organic functional groups that are relatively or completely inert with respect of hydrolysis. Based on the chemical structure an estimation of the hydrolysis rate is not possible. This statement is supported by one hydrolysis study performed on the registered substance with a method similar to OECD Guideline 111 but without GLP statement.

The disappearance of the parent compound after 5 days at 40 °C and at environmentally relevant pH is between10 and 20 % (and around 50 % at pH 12). Therefore, in environmentally relevant pH, the registered substance is considered hydrolytically stable. In conclusion, a GLP study is scientifically unjustified.