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Hydrolysis

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Reference
Endpoint:
hydrolysis
Type of information:
experimental study
Adequacy of study:
key study
Study period:
04 April 2016 to 09 Sep 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
EU Method C.7 (Degradation: Abiotic Degradation: Hydrolysis as a Function of pH)
Version / remarks:
30 May 2008
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 111 (Hydrolysis as a Function of pH)
Version / remarks:
13 April 2004
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Specific details on test material used for the study:
Identification: FAT 21036/G TE
Appearance/Physical state: Blue solid
Batch: AT-0033945200
Purity: 64.5%
Expiry date: 13 April 2020
Storage conditions: Approximately 4 °C, in the dark
Radiolabelling:
no
Analytical monitoring:
yes
Details on sampling:
The sample solutions were taken from the waterbath at various times and the pH of each solution recorded. The concentration of the sample solution was determined by high performance liquid chromatography (HPLC). Aliquots of the samples were taken for analysis without any further treatment.
Buffers:
Specification of the Buffer Solutions

Buffer solution
(pH) Components Concentration(mmol dm-3)
4 Citric acid 6
Sodium chloride 4
Sodium hydroxide 7
7 Disodium hydrogen orthophosphate (anhydrous) 3
Potassium dihydrogen orthophosphate 2
Sodium chloride 2
9 Disodium tetraborate 1
Sodium chloride 2
These solutions were subjected to ultrasonication and degassing with nitrogen to minimize dissolved oxygen content.
Details on test conditions:
Performance of the Test

Preparation of the Test Solutions
Sample solutions were prepared in stoppered glass flasks at a nominal concentration of 100 mg/L in the three buffer solutions.
The test solutions were split into individual vessels for each data point. The solutions were shielded from light whilst maintained at the test temperature.

Preliminary Test / Tier 1
Sample solutions at pH 4, 7 and 9 were maintained at 50.0 ± 0.5 °C for a period of 144 hours.

Tier 2
Results from the Preliminary Test / Tier 1 showed it was not necessary to undertake further testing at pH 4, pH 7 and pH 9.
Duration:
144 h
pH:
4
Temp.:
50 °C
Initial conc. measured:
100 mg/L
Duration:
144 h
pH:
7
Temp.:
50 °C
Initial conc. measured:
100 mg/L
Duration:
144 h
pH:
9
Temp.:
50 °C
Initial conc. measured:
100 mg/L
Positive controls:
no
Negative controls:
yes
Remarks:
Relevant pH buffer solutions
Preliminary study:
Less than 10% hydrolysis was observed at the end of the preliminary test with pH 4, 7 and 9.
Transformation products:
not measured
% Recovery:
> 94 - < 94.1
pH:
4
Temp.:
50 °C
Duration:
144 h
Remarks on result:
hydrolytically stable based on preliminary test
% Recovery:
> 79.9 - < 98.3
pH:
7
Temp.:
50 °C
Duration:
144 h
Remarks on result:
hydrolytically stable based on preliminary test
% Recovery:
> 89.9 - < 89.9
pH:
9
Temp.:
50 °C
Duration:
144 h
Remarks on result:
hydrolytically stable based on preliminary test
Key result
pH:
4
Temp.:
50 °C
DT50:
> 1 yr
Type:
not specified
Remarks on result:
hydrolytically stable based on preliminary test
Key result
pH:
7
Temp.:
50 °C
DT50:
> 1 yr
Type:
not specified
Remarks on result:
hydrolytically stable based on preliminary test
Key result
pH:
9
Temp.:
50 °C
DT50:
> 1 yr
Type:
not specified
Remarks on result:
hydrolytically stable based on preliminary test
Details on results:
TEST CONDITIONS
- pH, sterility, temperature, and other experimental conditions maintained throughout the study: Yes
- Anomalies or problems encountered (if yes): None

MAJOR TRANSFORMATION PRODUCTS
At pH4: At the end of the study period, the corresponding concentrations were 94.1 and 94.0 % of the applied amount, respectively.

At pH7: At the end of the study period, the corresponding concentrations were 97.9 and 98.3% of the applied amount, respectively.

At pH9: At the end of the study period, the corresponding concentrations were 89.9 and 89.9 % of the applied amount, respectively.

pH 4 at 50.0 ± 0.5 ºC

 

Time (Hours)

Concentration (g/L)

% of Mean Initial Concentration

A

B

A

B

0

0.101

0.100

-

-

24

9.96 x 10-2

9.90 x 10-2

99.1

98.5

120

9.54 x 10-2

9.50 x 10-2

94.9

94.6

144

9.46 x 10-2

9.45 x 10-2

94.1

94.0

Result: Less than 10 % hydrolysis after 5 days at 50 °C, equivalent to a half-life of greater than 1 year at 25 °C.

 

pH 7 at 50.0 ± 0.5 ºC

 

Time (Hours)

Concentration (g/L)

% of Mean Initial Concentration

A

B

A

B

0

9.96 x 10-2

9.95 x 10-2

-

-

24

9.78 x 10-2

0.100

98.2

101

120

9.89 x 10-2

9.76 x 10-2

99.3

98.0

144

9.75 x 10-2

9.79 x 10-2

97.9

98.3

Result: Less than 10 % hydrolysis after 5 days at 50 °C, equivalent to a half-life of greater than 1 year at 25 °C.

pH 9 at 50.0 ± 0.5 ºC

 

Time (Hours)

Concentration (g/L)

% of Mean Initial Concentration

A

B

A

B

0

0.107

0.108

-

-

24

0.106

0.105

98.6

97.8

120

9.72 x 10-2

9.77 x 10-2

90.5

91.0

144

9.66 x 10-2

9.65 x 10-2

89.9

89.9

 

Result: Less than 10% hydrolysis after 5 days at 50 °C, equivalent to a half-life of greater than 1 year at 25 °C.

Validity criteria fulfilled:
yes
Conclusions:
The estimated half-life at 25 °C at pH 4,7 and 9 was found to be >1 year for all pH-levels tested.
Executive summary:

A study was performed to Assess hydrolytic stability using a procedure designed to be compatible with Method C.7 Abiotic Degradation, Hydrolysis as a Function of pH of Commission Regulation (EC) No 440/2008 of 30 May 2008 and Method 111 of the OECD Guidelines for Testing of Chemicals, 13 April 2004. The test system consisted of sterile buffer solutions at pH 4, 7 and 9. Sample solutions at pH 4, 7 and 9 were maintained at 50.0 ± 0.5 °C for a period of 144 hours. Analytical validation was carried out using HPLC method. Less than 10 % hydrolysis was observed at the end of the preliminary test with pH 4, 7 and 9. Hence, the estimated half-life at 25 °C at pH 4,7 and 9 was found to be  >1 year for all pH-levels tested.

Description of key information

A study was performed to Assess hydrolytic stability using a procedure designed to be compatible with Method C.7 Abiotic Degradation, Hydrolysis as a Function of pH of Commission Regulation (EC) No 440/2008 of 30 May 2008 and Method 111 of the OECD Guidelines for Testing of Chemicals, 13 April 2004. The test system consisted of sterile buffer solutions at pH 4, 7 and 9. Sample solutions at pH 4, 7 and 9 were maintained at 50.0 ± 0.5 °C for a period of 144 hours. Analytical validation was carried out using HPLC method. Less than 10 % hydrolysis was observed at the end of the preliminary test with pH 4, 7 and 9. Hence, the estimated half-life at 25 °C at pH 4,7 and 9 was found to be  >1 year for all pH-levels tested. FAT 21036/G was determined to be hydrolytically stable.

Key value for chemical safety assessment

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

Additional information