Registration Dossier

Environmental fate & pathways

Hydrolysis

Currently viewing:

Administrative data

Link to relevant study record(s)

Reference
Endpoint:
hydrolysis
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Remarks:
experimental data of read across substances
Justification for type of information:
Data for the target chemical is summarized based on the structurally similar read across chemicals
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Qualifier:
according to guideline
Guideline:
other: as mentioned below
Principles of method if other than guideline:
WoE report is based on two hydrolysis studies as-
2. and 3.
GLP compliance:
not specified
Radiolabelling:
yes
Remarks:
2. yes and 3. Not specified
Analytical monitoring:
yes
Remarks:
2. yes and 3. Not specified
Duration:
5 d
Temp.:
50 °C
Initial conc. measured:
ca. 10 mg/L
Remarks:
2. pH range used for the study was 4, 7 and 9, respectively
pH:
7
Temp.:
20 °C
Remarks:
3. Other details not known
Positive controls:
not specified
Negative controls:
not specified
Transformation products:
no
Remarks:
2. No transformation product was formed and 3. Not specified
% Recovery:
99
pH:
4
Temp.:
50 °C
Duration:
5 d
Remarks on result:
other: 2. % recovery: 100%, 97.5% (average 99.0%)
% Recovery:
99.5
pH:
7
Temp.:
50 °C
Duration:
5 d
Remarks on result:
other: 2. % recovery: 99.8%, 99.2% (average 99.5%)
% Recovery:
99.7
pH:
9
Temp.:
50 °C
Duration:
5 d
Remarks on result:
other: 2. % recovery: 98.8%, 98.6% (average 98.7%)
Temp.:
50 °C
DT50:
> 5 d
Type:
not specified
Remarks on result:
other: 2. pH range used for the study was 4, 7 and 9, respectively
pH:
7
Temp.:
20 °C
DT50:
> 1 yr
Remarks on result:
other: 3. Other details not known
Details on results:
2. Test chemical was reported to be hydrolytically stable at pH 4, 7 and 9, respectively at a temperature of 50⁰C for 5 days.

3. The only functional group present is the amide group, which hydrolyzes very slowly at neutral pH.
Validity criteria fulfilled:
not specified
Conclusions:
On the basis of the experimental studies of the structurally and functionally similar read across chemical and applying the weight of evidence approach, the hydrolysis half-life value of the test chemical can be expected to be > 5 days at pH 4, 7 and 9 & at a temperature of 50⁰C, respectively or > 1 years at pH 7 & at a temperature of 20⁰C, respectively.
Executive summary:

Data available for the structurally and functionally similar read across chemicals has been reviewed to determine the half-life of the test chemical.The studies are as mentioned below:

The half-life of the test chemical was determined at different pH range. The study was performed according to OECD Guideline 111 (Hydrolysis as a Function of pH) at a temperature of 50°C. The average percentage recovery of the test chemical after 5 days was determined to be 99.0, 99.5 and 98.7% at pH 4, 7 and 9, respectively. As no hydrolysis of test item was observed for a period of 5 days, the half-lives was determined to be > 5 days at pH 4, 7 and 9 & at a temperature of 50⁰C, respectively. Based on the half-life values, it is concluded that the test substance is not hydrolysable.

In an another study, the half-life of the test chemical was determined at pH 7.0. The study was performed at a temperature of 50°C. The only functional group present is the amide group, which hydrolyzes slowly at neutral pH. The half-life value of the test chemical was determined to be > 1 years at pH 7 & at a temperature of 20⁰C, respectively. Based on the half-life value, it is concluded that test chemical is not hydrolysable.

On the basis of the experimental studies of the structurally and functionally similar read across chemical and applying the weight of evidence approach, the hydrolysis half-life value of the test chemical can be expected to be > 5 days at pH 4, 7 and 9 & at a temperature of 50⁰C, respectively or  > 1 years at pH 7 & at a temperature of 20⁰C, respectively.

Description of key information

On the basis of the experimental studies of the structurally and functionally similar read across chemical and applying the weight of evidence approach, the hydrolysis half-life value of the test chemical can be expected to be > 5 days at pH 4, 7 and 9 & at a temperature of 50⁰C, respectively or > 1 years at pH 7 & at a temperature of 20⁰C, respectively.

Key value for chemical safety assessment

Additional information

Data available for the structurally and functionally similar read across chemicals has been reviewed to determine the half-life of the test chemical. The studies are as mentioned below:

 

The half-life of the test chemical was determined at different pH range. The study was performed according to OECD Guideline 111 (Hydrolysis as a Function of pH) at a temperature of 50°C. The average percentage recovery of the test chemical after 5 days was determined to be 99.0, 99.5 and 98.7% at pH 4, 7 and 9, respectively. As no hydrolysis of test item was observed for a period of 5 days, the half-lives was determined to be > 5 days at pH 4, 7 and 9 & at a temperature of 50⁰C, respectively. Based on the half-life values, it is concluded that the test substance is not hydrolysable.

 

In an another study, the half-life of the test chemical was determined at pH 7.0. The study was performed at a temperature of 50°C. The only functional group present is the amide group, which hydrolyzes slowly at neutral pH. The half-life value of the test chemical was determined to be > 1 years at pH 7 & at a temperature of 20⁰C, respectively. Based on the half-life value, it is concluded that test chemical is not hydrolysable.

 

On the basis of the experimental studies of the structurally and functionally similar read across chemical and applying the weight of evidence approach, the hydrolysis half-life value of the test chemical can be expected to be > 5 days at pH 4, 7 and 9 & at a temperature of 50⁰C, respectively or > 1 years at pH 7 & at a temperature of 20⁰C, respectively.