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Environmental fate & pathways

Hydrolysis

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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:
other: 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 raw materials in a series of simple media simulating perfumery applications. The test media are standard aqueous buffers at pH 2, pH 5, pH 7 and pH 8.5 containing 1 % of non-ionic surfactant. The tests are done in accelerated conditions at 40 °C during ca. one month.
GLP compliance:
no
Specific details on test material used for the study:
No additional information
Radiolabelling:
no
Analytical monitoring:
yes
Details on sampling:
200 – 300 ppm of raw material was 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 analysed 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
Estimation method (if used):
Not applicable
Details on test conditions:
No data
Duration:
28 d
pH:
2
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:
7
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
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 substance is stable at acidic and neutral pHs. At pH = 8.5 the substance degrades and concentration decays to less than 20% after 25 days.
% Recovery:
> 90
pH:
2
Temp.:
40 °C
Duration:
28 d
% Recovery:
ca. 90
pH:
5
Temp.:
40 °C
Duration:
28 d
% Recovery:
> 70 - < 80
pH:
7
Temp.:
40 °C
Duration:
28 d
% Recovery:
> 10 - < 20
pH:
8.5
Temp.:
40 °C
Duration:
28 d
Other kinetic parameters:
None
Details on results:
No data

None

Validity criteria fulfilled:
yes
Conclusions:
Results showed that the substance is stable at acidic and neutral pHs. At pH = 8.5 the substance degrades and concentration decays to less than 20% after 25 days. It can be therefore concluded that under the conditions of the present test, the substance is stable (as defined in the OECD TG 111 for hydrolysis as a function of pH).
Executive summary:

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 and pH 8.5 containing 1% of non- ionic surfactant. The tests are done in accelerated conditions at 40 °C during ca. one month.

200 – 300 ppm of raw material was 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 analysed 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 results showed  that the substance is stable at acidic and neutral pHs. At pH = 8.5 the substance degrades and concentration decays to less than 20% after 25 days. It can be therefore concluded that under the conditions of the present test, the substance is stable (as defined in the OECD TG 111 for hydrolysis as a function of pH).

Endpoint:
hydrolysis
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because the substance is readily biodegradable
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
In accordance with REACH Annex VIII column 2, the hydrolysis study does not need to be conducted because the registered substance is readily biodegradable.

Description of key information

In accordance with REACH Annex VIII column 2, hydrolysis study does not need to be conducted because the registered substance is readily biodegradable.

However, one stability test, not performed according to international guideline and not GLP, was performed on the registered substance and included in the dossier as a supporting information. In this study, the substance is stable at acidic and neutral pHs (from 5 to 7). At pH 8.5, the substance degraded and concentration decays to less than 20% after 25 days. However, it can be concluded that under the conditions of the test, the substance is stable, as defined in the OECD Guideline 111 for hydrolysis as a functon of pH.

Key value for chemical safety assessment

Additional information