Registration Dossier

Diss Factsheets

Environmental fate & pathways

Hydrolysis

Currently viewing:

Administrative data

Link to relevant study record(s)

Reference
Endpoint:
hydrolysis
Type of information:
experimental study
Adequacy of study:
key study
Study period:
16th September 2020 to 12th March 2021
Reliability:
1 (reliable without restriction)
Qualifier:
according to guideline
Guideline:
OECD Guideline 111 (Hydrolysis as a Function of pH)
GLP compliance:
yes (incl. QA statement)
Analytical monitoring:
no
Details on sampling:

109.06 mg of the test item was dissolved in acetonitrile and adjusted to the mark with acetonitrile in a 10 mL graduated flask to prepare a solution with a concentration of 10906 mg test item per litre. Defined volumes of 0.092 mL of this solution were diluted to 10 mL with buffer solution in screw glass bottles, resulting in a test item concentration of 100.3 mg/L.


A defined volume of 0.7 mL of the samples was diluted to 1 mL with acetonitrile. This results in a nominal concentration in the diluted sample solution of 70.2 mg/L. These samples were analysed by HPLC-UV.
Buffers:
pH 4

A mixture of 0.1 M potassium citrate (500 mL), 0.1 M sodium hydroxide (80 mL) and water (400 mL) was adjusted to pH 4.00 with 0.1 M sodium hydroxide and filled up to the mark with water in a 1 L graduated flask.

pH 7

A mixture of 0.0667 M potassium dihydrogenphosphate (587 mL) and 0.067 M disodium hydrogenphosphate (400 mL), was adjusted to pH 7.00 with 0.067 M disodium hydrogenphosphate.

pH 9

A mixture of 0.1 M boric acid in 0.1 M potassium chloride (500 mL), 0.1 M sodium hydroxide (100 mL) and water (380 mL) was adjusted to pH 9.00 with 0.1 M sodium hydroxide and filled up to the mark with water in a 1 L graduated flask.
Duration:
5 d
pH:
9
Temp.:
50 °C
Initial conc. measured:
ca. 100.3 mg/L
Duration:
1 d
pH:
9
Temp.:
50 °C
Initial conc. measured:
ca. 100.3 mg/L
Duration:
5 d
pH:
7
Temp.:
50 °C
Initial conc. measured:
ca. 100.3 mg/L
Duration:
1 d
pH:
7
Temp.:
50 °C
Initial conc. measured:
ca. 100.3 mg/L
Duration:
5 d
pH:
4
Temp.:
50 °C
Initial conc. measured:
ca. 100.3 mg/L
Duration:
1 d
pH:
4
Temp.:
50 °C
Initial conc. measured:
ca. 100.3 mg/L
Number of replicates:
2 replicates for each timepoint and pH
Positive controls:
no
Negative controls:
no
Preliminary study:
A preliminary test at 50 C and 5 days of incubation was carried out. Since the test item was completely stable under the conditions of the preliminary test, no advance test was carried out.
Test performance:
None
Transformation products:
no
Details on hydrolysis and appearance of transformation product(s):
- Formation and decline of each transformation product during test:
- Pathways for transformation:
- Other:
% Recovery:
ca. 104
pH:
9
Temp.:
50 °C
Duration:
ca. 5 d
% Recovery:
ca. 101
pH:
9
Temp.:
50 °C
Duration:
ca. 1 d
% Recovery:
ca. 105
pH:
7
Temp.:
50 °C
Duration:
ca. 5 d
% Recovery:
ca. 102
pH:
7
Temp.:
50 °C
Duration:
ca. 1 d
% Recovery:
ca. 106
pH:
4
Temp.:
50 °C
Duration:
ca. 5 d
% Recovery:
ca. 101
pH:
4
Temp.:
50 °C
Duration:
ca. 1 d
Key result
Remarks on result:
hydrolytically stable based on preliminary test
Details on results:
Preliminary study indicates that the substance is hydrolytically stable and no further study was performed
Results with reference substance:
Preliminary study indicates that the substance is hydrolytically stable and no further study was performed

Preliminary study indicates that the substance is hydrolytically stable and no further study was performed

Validity criteria fulfilled:
yes
Conclusions:
The test item is hydrolytically stable in aqueous buffer solutions at a pH 4, 7 and 9 for at least 5 days at 50 oC.
Executive summary:

The hydrolysis of BPA EO was determined by OECD guideline 111: Hydrolysis as a function of pH.  The test was carried out at 50 oC.  Samples of the test items were prepared in buffer solutions at pH 4, 7 and 9 and incubated for up to 5 days. 


The test item was found to be stable at pH 4, 7 and 9 under the conditions of the test with recovered of 101-102% after day 1 and 104-106% after 5 days.  The tentative hydrolysis product bisphenol A was not detected in the samples.


Thus, the test item was hydrolytically stable at pH 4, 7 and 9 during 5 days at 50 C.

Description of key information

The hydrolysis of BPA EO was determined by OECD guideline 111: Hydrolysis as a function of pH.  The test was carried out at 50 oC.  Samples of the test items were prepared in buffer solutions at pH 4, 7 and 9 and incubated for up to 5 days. 


The test item was found to be stable at pH 4, 7 and 9 under the conditions of the test with recovered of 101-102% after day 1 and 104-106% after 5 days.  The tentative hydrolysis product bisphenol A was not detected in the samples.


Thus, the test item was hydrolytically stable at pH 4, 7 and 9 during 5 days at 50 C.

Key value for chemical safety assessment

Additional information