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Environmental fate & pathways

Hydrolysis

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Reference
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:
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)
Version / remarks:
13 April 2004
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
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 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:
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
Duration:
28 d
pH:
12
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:
No data
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 and 28 days at 40 °C at pH 5 is less than 10 %. At pH 7 and 8.5, the disappearance of the parent compound is between 30 and 70% after 28 days at 40°C. At higher pH (pH of 12), the parent compound rapidly disappears as of day 1.
% Recovery:
100
pH:
2
Temp.:
40 °C
Duration:
1 d
% Recovery:
50
pH:
2
Temp.:
40 °C
Duration:
20 d
% Recovery:
100
pH:
5
Temp.:
40 °C
Duration:
1 d
Remarks on result:
other: Registered substance is hydrolytically stable, less than 5% disappeared after 28 days.
% Recovery:
98
pH:
5
Temp.:
40 °C
Duration:
28 d
Remarks on result:
other: registered substance is hydrolytically stable, less than 5% disappeared after 28 days.
% Recovery:
88
pH:
7
Temp.:
40 °C
Duration:
5 d
% Recovery:
69
pH:
7
Temp.:
40 °C
Duration:
28 d
% Recovery:
85
pH:
8.5
Temp.:
40 °C
Duration:
1 d
% Recovery:
50
pH:
8.5
Temp.:
40 °C
Duration:
9.6 d
% Recovery:
50
pH:
12
Temp.:
40 °C
Duration:
0.2 d
pH:
2
Temp.:
40 °C
DT50:
ca. 20 d
pH:
8.5
Temp.:
40 °C
DT50:
ca. 9.6 d
pH:
12
Temp.:
40 °C
DT50:
ca. 0.2 d
Other kinetic parameters:
None
Details on results:
No additional information
Results with reference substance:
None
Validity criteria fulfilled:
not applicable
Conclusions:
The disappearance of the parent compound after 28 days at 40 °C and at environmentally relevant pH (comprised between 5 and 8.5) is comprised between less than 5 and 70 %.
Half-life values were determined at the following pH:
pH Half-life (day)
2 20
8.5 9.6
12 0.2
Executive summary:

Hydrolysis study was performed similar to OECD Guideline No. 111. 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 28 days.

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.

 The disappearance of the parent compound after 28 days at 40 °C is circa 70% at pH 2, less than 5% at pH 5, circa 31% at pH 7 and circa 70% at pH 8.5, and 100% disappearance at pH 12.

Description of key information

As the registered substance is not readily biodegradable, a GLP hydrolysis study does need to be conducted, in accordance with REACH Annex VIII column 2. One study was available:

A non-GLP stability test was performed on the registered substance with a method similar to OECD Guideline No. 111, in accelerated conditions at 40 °C during 28 days. The disappearance of the substance after 28 days at 40 °C and at environmentally relevant pH (comprised between 5 and 8.5) is comprised between less than 5% and 70%.

Key value for chemical safety assessment

Additional information