Registration Dossier

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:
24 December 2015 to 08 March 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 111 (Hydrolysis as a Function of pH)
Qualifier:
according to
Guideline:
EU Method C.7 (Degradation: Abiotic Degradation: Hydrolysis as a Function of pH)
Qualifier:
according to
Guideline:
EPA OPPTS 835.2120 (Hydrolysis of Parent and Degradates as a Function of pH at 25°C)
Principles of method if other than guideline:
Only a preliminary test was performed.
GLP compliance:
yes
Radiolabelling:
no
Analytical monitoring:
yes
Details on sampling:
- Sampling intervals for the parent products: at start and day 5
- Sampling method: in duplicate
- Sampling intervals/times for pH measurements: at start and day 5
- Sample storage conditions before analysis: analyzed immediately
Buffers:
Acetate buffer pH 4, 0.01 M:
solution of 16.7% (v/v) 0.01 M sodium acetate in water and 83.3% (v/v) 0.01 M acetic acid in water. The buffer contains 0.0009% (w/v) sodium azide.
Phosphate buffer pH 7, 0.01 M:
solution of 0.01 M potassium di-hydrogenphosphate in water adjusted to pH 7 using 1 N sodium hydroxide. The buffer contains 0.0009% (w/v) sodium azide.
Borate buffer pH 9, 0.01 M :
solution of 0.01 M boric acid in water and 0.01 M potassium chloride in water adjusted to pH 9 using 1 N sodium hydroxide. The buffer contains 0.0009% (w/v) sodium azide
Details on test conditions:
TEST SYSTEM
- Type, material and volume of test flasks, other equipment used: sterile vessel containing 6 mL test solution
- Sterilisation method: filter-sterilised through a 0.2 µm FP 30/0.2 CA-S filter (Whatman, Dassel, Germany)
- Lighting: in dark (all test solutions were protected from light at any time)
- Measures to exclude oxygen: nitrogen gas purged through solution
- Is there any indication of the test material adsorbing to the walls of the test apparatus; no
- Test temperature: 50.0°C ± 0.1°C
TEST MEDIUM
- Volume used/treatment: 6 mL (1.00 mg/L)
- Kind and purity of water: milli-Q water
- Preparation of test medium: sterilised through a 0.2 um filter

Number of replicates:
2 replicates/ pH-value
Positive controls:
no
Negative controls:
not specified
Remarks:
blanks were included but not reported
Statistical methods:
NA
Preliminary study:
Hydrolysis was < 10% at all pH values. The concomittant t1/2 is > 1 year at 25 °C
Test performance:
In view of the results of the preliminary study no further tests were performed
Transformation products:
not measured
% Recovery:
96.4
pH:
4
Temp.:
50 °C
Duration:
5 d
Remarks on result:
hydrolytically stable based on preliminary test
% Recovery:
91.1
pH:
7
Temp.:
50 °C
Duration:
5 d
Remarks on result:
hydrolytically stable based on preliminary test
% Recovery:
102.4
pH:
9
Temp.:
50 °C
Duration:
5 d
Remarks on result:
hydrolytically stable based on preliminary test
pH:
4
Remarks on result:
hydrolytically stable based on preliminary test
pH:
7
Remarks on result:
hydrolytically stable based on preliminary test
pH:
9
Remarks on result:
hydrolytically stable based on preliminary test

Preliminary hydrolysis test of the test substance at pH 4, pH 7 and pH 9

pH code

Sampling time

Analysed concentration
[mg/L]

Degree of hydrolysis
[%]

Actual pH

Individual

Mean

 

 

 

 

 

 

pH 4

0 hours

0.983

 

 

4.0

 

 

1.01

 

 

4.1

 

 

 

 

 

 

 

5 days

0.948

4.7

3.6

4.1

 

 

0.972

2.4

 

4.1

 

 

 

 

 

 

pH 7

0 hours

1.04

 

 

7.0

 

 

1.03

 

 

7.0

 

 

 

 

 

 

 

5 days

0.936

9.7

8.9

7.0

 

 

0.952

8.2

 

7.0

 

 

 

 

 

 

pH 9

0 hours

1.00

 

 

8.9

 

 

0.998

 

 

8.9

 

 

 

 

 

 

 

5 days

1.02

-2.6

-2.4

8.9

 

 

1.02

-2.2

 

8.9

Validity criteria fulfilled:
yes
Conclusions:
The hydrolysis rate of the substance at pH 4, 7 and 9 is >1 year
Executive summary:

In a hydrolysis study performed according to OECD 111, the preliminary test at pH 4, 7 and 9 showed hydrolysis < 10% at 50 °C over the 5 day test period..

It can therefore be concluded that the hydrolysis rate of the substance at all tested pH values is > 1 year.

Description of key information

In a hydrolysis study performed according to OECD 111, the preliminary test at pH 4, 7 and 9 showed hydrolysis < 10% at 50 °C over the 5 day test period..

The substance is considered hydrolytically stable.

Key value for chemical safety assessment

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

Additional information