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Diss Factsheets

Environmental fate & pathways

Hydrolysis

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Administrative data

Link to relevant study record(s)

Reference
Endpoint:
hydrolysis
Type of information:
experimental study
Adequacy of study:
key study
Study period:
from 2008-03-14 till 2008-03-21
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline-conform study under GLP without deviations.
Qualifier:
according to guideline
Guideline:
EU Method C.7 (Degradation: Abiotic Degradation: Hydrolysis as a Function of pH)
Version / remarks:
; OECD 111 (2004)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Radiolabelling:
no
Analytical monitoring:
yes
Duration:
120 h
pH:
4
Temp.:
50 °C
Initial conc. measured:
1 560 mg/L
Duration:
120 h
pH:
7
Temp.:
50 °C
Initial conc. measured:
1 560 mg/L
Duration:
120 h
pH:
9
Temp.:
50 °C
Initial conc. measured:
1 560 mg/L
Number of replicates:
Single replicate for each measuring date.
Positive controls:
no
Negative controls:
no
Preliminary study:
A preliminary test is performed at 50 ± 0.5°C at three pH values, 4.0 ; 7.0 and 9.0.
If this test indicates that 50% or more of the test article has been hydrolysed in 2.5 hours at 50°C, or less than 10% has been hydrolysed after five days at each of the three pH values (4.0 ; 7.0 and 9.0), no further testing is necessary.
Test performance:
The experiment is carried out at 50 +/- 0.5°C. and several samples of each pH solution are analysed at different times in order to cover a suitable range of hydrolysis to test for pseudo-first order behaviour of the reaction.

From data obtained by this test, it is reliably possible to conclude if the hydrolysis reaction is pseudo-first order, then the test is repeated for each pH value either at one temperature lower than 40°C or at two temperatures above 50°C, differing from each other by at least 10°C.
Transformation products:
no
Details on hydrolysis and appearance of transformation product(s):
The abiotic degradation hydrolysis for both cationic and anionic part of the test sample is lower than 10% after 5 days at 50°C for the three pH values (4.0, 7.0 and 9.0) tested. No transformation product(s) were analysed.
% Recovery:
ca. 99.9 - <= 100
pH:
4
Temp.:
50 °C
Duration:
5 d
Remarks on result:
hydrolytically stable based on preliminary test
% Recovery:
ca. 99.9 - <= 100
pH:
7
Temp.:
50 °C
Duration:
5 d
Remarks on result:
hydrolytically stable based on preliminary test
% Recovery:
ca. 99.9 - <= 100
pH:
9
Temp.:
50 °C
Duration:
5 d
Remarks on result:
hydrolytically stable based on preliminary test
Key result
pH:
4
Temp.:
50 °C
Type:
not specified
Remarks on result:
hydrolytically stable based on preliminary test
Key result
pH:
7
Temp.:
50 °C
Type:
not specified
Remarks on result:
hydrolytically stable based on preliminary test
Key result
pH:
9
Temp.:
50 °C
Type:
not specified
Remarks on result:
hydrolytically stable based on preliminary test
Details on results:
No abiotic hydrolytic degradation observable.TEST CONDITIONS
- pH, sterility, temperature, and other experimental conditions maintained throughout the study: Yes
- Anomalies or problems encountered (if yes): no


MINOR TRANSFORMATION PRODUCTS
Maximum concentrations in % of the applied amount:
- at pH5, pH7, pH9: The abiotic degradation hydrolysis for both cationic and anionic part of the test sample is lower than 10 % after 5 days at 50 °C for the three pH values (4.0, 7.0 and 9.0) tested.

Comments:
The abiotic degradation hydrolysis for both cationic and
anionic part of the test sample
is lower than 10 % after 5 days at 50 °C for the three pH
values (4.0, 7.0 and 9.0) tested.
Die Halbwertszeit t1/2 für den hydrolyt.Abbau beträgt > 8760 h (ph 7, 25 °C).

Validity criteria fulfilled:
yes
Conclusions:
From the experimental data obtained according to the guideline C.7 in Official Journal L 383 Part A, it can be concluded that the abiotic degradation hydrolysis for both cationic and anionic part of the test sample is lower than 10% after 5 days at 50°C for the three pH values (4.0, 7.0 and 9.0) tested.

Description of key information

not hydrolytic degradable

Key value for chemical safety assessment

Additional information

The substance cannot be considered to be abiotic degradable. At three pH values tested (4.0, 7.0 and 9.0) the degradation rate was less than 10%.