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Environmental fate & pathways

Hydrolysis

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Reference
Endpoint:
hydrolysis
Type of information:
experimental study
Adequacy of study:
key study
Study period:
July - August, 2014
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
OECD Guideline 111 (Hydrolysis as a Function of pH)
Version / remarks:
13 April, 2004
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method C.7 (Degradation: Abiotic Degradation: Hydrolysis as a Function of pH)
Version / remarks:
2008
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 835.2110 (Hydrolysis as a Function of pH)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Specific details on test material used for the study:
GR-50-1408 is the Givaudan identification code which was employed for ROSYFOLIA during the early, developmental and testing period.
Radiolabelling:
no
Analytical monitoring:
yes
Remarks:
GC-FID
Details on sampling:
Only the preliminary test was performed.

Duplicate samples from pH4, pH7 and pH9 incubated at 50°C were taken at Time 0, 6.0 hours and 120.0 hours for analysis.
Buffers:
pH 4:
Ready-made concentrate (Titrisol®, MERCK, Darmstadt, Germany, art. No. 9884, citrate / hydrochloric acid buffer) pH 4.00 ± 0.02 at 20°C.
pH 7:
Ready-made concentrate (Titrisol®, MERCK, Darmstadt, Germany, art. No. 9887, phosphate buffer) pH 7.00 ± 0.02 at 20°C.
pH 9:
Ready-made concentrate (Titrisol®, MERCK, Darmstadt, Germany, art. No. 9889, boric acid / potassium chloride / sodium hydroxide buffer) pH 9.00 ± 0.02 at 20°C.

In order to avoid any unnecessary excess of inorganic salts that could reduce the solubility of the test substance, these buffer solutions were diluted to 10% with ultrapure water before being used as test media.
Details on test conditions:
No special sterilising treatment other than heating the glassware to 160 °C overnight prior to use was applied.

Only a preliminary test was performed.
Duration:
120 h
pH:
9
Temp.:
50 °C
Initial conc. measured:
27.6 mg/L
Remarks:
Time 0 average concentration of duplicate samples = 27.6 mg/L (Sample A 28.2 mg/L, Sample B 27.0 mg/L). Respective average test item concentrations (Samples A and B) detected at 6 hours and 120 hours = 27.2 mg/L and 28.1 mg/L.
Duration:
120 h
pH:
7
Temp.:
50 °C
Initial conc. measured:
26.6 mg/L
Remarks:
Time 0 average concentration of duplicate samples = 26.6 mg/L (Sample A 26.7 mg/L, Sample B 26.4 mg/L). Respective average test item concentrations (Samples A and B) detected at 6 hours and 120 hours = 21.8 mg/L (considered outlier) and 25.8 mg/L.
Duration:
120 h
pH:
4
Temp.:
50 °C
Initial conc. measured:
28.4 mg/L
Remarks:
Time 0 average concentration of duplicate samples = 28.4 mg/L (Sample A 28.4 mg/L, Sample B 28.5 mg/L). Respective average test item concentrations (Samples A and B) detected at 6 hours and 120 hours = 26.7 mg/L and 25.7 mg/L.
Number of replicates:
Duplicate samples taken at each time interval for each pH.
Positive controls:
no
Negative controls:
no
Statistical methods:
None.
Preliminary study:
Solutions of the test substance in the different buffer solutions were prepared. For each pH, 20 crimp cap vials (20ml) were filled with 10ml of the respective solution, sealed with Teflon coated rubber septa crimp cap, and placed in the water bath at 50 °C. After temperature equilibration, a first pair of vials was extracted for each pH by direct addition of a weighted test substance sample in an aluminium capsule.
This is time zero of the experiment. At given times other two vials per buffer solution were sacrificed for analysis.
Transformation products:
no
% Recovery:
101.8
pH:
9
Temp.:
50 °C
Duration:
120 h
Remarks on result:
hydrolytically stable based on preliminary test
Remarks:
Time 0 average concentration of duplicate samples = 27.6 mg/L. Respective average test item concentrations at 120 hours = 28.1 mg/L (101.8% of Time 0).
% Recovery:
97
pH:
7
Temp.:
50 °C
Duration:
120 h
Remarks on result:
hydrolytically stable based on preliminary test
Remarks:
Time 0 average concentration of duplicate samples = 26.6 mg/L. Respective average test item concentrations at 120 hours = 25.8 mg/L (97.1% of Time 0)
% Recovery:
90.5
pH:
4
Temp.:
50 °C
Duration:
120 h
Remarks on result:
hydrolytically stable based on preliminary test
Remarks:
Time 0 average concentration of duplicate samples = 28.4 mg/L. Respective average test item concentrations at 120 hours = 25.7 mg/L (90.5% of Time 0).
Key result
pH:
9
Temp.:
25 °C
DT50:
> 1 yr
Remarks on result:
hydrolytically stable based on preliminary test
Key result
pH:
7
Temp.:
25 °C
DT50:
> 1 yr
Remarks on result:
hydrolytically stable based on preliminary test
Key result
pH:
4
Temp.:
25 °C
DT50:
> 1 yr
Remarks on result:
hydrolytically stable based on preliminary test
Details on results:
Only a preliminary test was performed. This is aligned with the criterion given in the guidelines:
If less that 10% degradation after 120 hours (equivalent to a half-life time higher than 1 year at 25 °C) is observed, no further testing is necessary.
This criterion is fulfilled for pH 4, pH 7 and pH 9. For all three pH <10% degradation was observed at 50 °C over a 120 hours period (0h to 120h).
Conclusions:
An abiotic degradation stuudy (hydrolysis as a function of pH) was carried out with GR-50-1408 according to OECD guideline no 111.
Only the preliminary test needed to be performed since, at 50 degrees C, less than 10% hydrolysis occurred at all three pH values of 4, 7 and 9 after 120h. A hydrolysis of less than 10% after 120h, or more, at 50 degrees C corresponds to a half-life time of more than one year at 25 degrees C.
Therefore, the half-life time of GR-50 -1408 at 25 degrees C is higher than one year at pH 4, pH 7 and pH 9.

Description of key information

For the registration substance, only the preliminary test needed to be performed since, at 50 degrees C, less than 10% hydrolysis occurred at all three pH values of 4, 7 and 9 after 120h. A hydrolysis of less than 10% after 120h, or more, at 50 degrees C corresponds to a half-life time of more than one year at 25 degrees C.

Therefore, the half-life time of GR-50 -1408 at 25 degrees C is higher than one year at pH 4, pH 7 and pH 9.

Key value for chemical safety assessment

Half-life for hydrolysis:
1 yr
at the temperature of:
25 °C

Additional information