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Environmental fate & pathways

Hydrolysis

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Reference
Endpoint:
hydrolysis
Type of information:
experimental study
Adequacy of study:
key study
Study period:
29 Nov - 10 Dec 2004
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
other: “Test on Hydrolyzability” of agricultural chemicals stipulated in the “Notification Concerning Test Data for Registration of Agricultural Chemicals” (12 Nohsan No. 8147)
Version / remarks:
November 24, 2000, revised on December 10, 2002
Deviations:
not specified
Qualifier:
according to guideline
Guideline:
OECD Guideline 111 (Hydrolysis as a Function of pH)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Radiolabelling:
no
Analytical monitoring:
yes
Details on sampling:
- Sampling intervals for the parent/transformation products: The test solution was quantitatively analyzed at each measurement point
- Sampling intervals/times for pH measurements: Days 0 and 5
Buffers:
pH 4: 2 ml of 0.1 N sodium hydroxide was added to 250 mL of 0.1 M potassium hydrogen phthalate and the volume was adjusted to 500 mL with purified water.
pH 7: 148 mL of 0.1 N sodium hydroxide was added to 250 mL of 0.1 M potassium dihydrogen phosphate and the volume was adjusted to 500 mL with purified water.
pH 9: 106 mL of 0.1 N sodium hydroxide was added to 250 mL of 0.1M boric acid and the volume was adjusted to 500 mL with purified water.
Details on test conditions:
TEST SYSTEM
- Type, material and volume of test flasks, other equipment used: Glass-stoppered Erlenmeyer flask (100 mL capacity, glass)
- Sterilisation method: use of an autoclave
- Measures to exclude oxygen: Nitrogen gas was bubbled through each buffer solution for 5 minutes to expel dissolved oxygen
TEST MEDIUM
- Volume used/treatment: 100 mL
- Preparation of test medium: The test substance stock solution (2.50 mL) was withdrawn and diluted with the buffer solution of desired pH to prepare the test solution (250 mL)
Duration:
5 d
pH:
4
Temp.:
50 °C
Initial conc. measured:
100 mg/L
Duration:
5 d
pH:
7
Temp.:
50 °C
Initial conc. measured:
100 mg/L
Duration:
5 d
pH:
9
Temp.:
50 °C
Initial conc. measured:
100 mg/L
Number of replicates:
2
Positive controls:
no
Negative controls:
no
Transformation products:
not measured
% Recovery:
94.3
pH:
4
Temp.:
50 °C
Duration:
5 d
pH:
7
Temp.:
50 °C
Duration:
5 d
Remarks on result:
other:
Remarks:
Total recovery of test substance: 101%
% Recovery:
100
pH:
9
Temp.:
50 °C
Duration:
5 d
Key result
pH:
4
Temp.:
25 °C
DT50:
> 1 yr
Type:
not specified
Key result
pH:
7
Temp.:
25 °C
DT50:
> 1 yr
Type:
not specified
Key result
pH:
9
Temp.:
25 °C
DT50:
> 1 yr
Type:
not specified
Details on results:
TEST CONDITIONS
- pH, sterility, temperature, and other experimental conditions maintained throughout the study: Yes/

Description of key information

The test substance was shown to be hydrolytically stable at pH 4, 7, and 9 (DT50: > 1 year at 25 °C).

Key value for chemical safety assessment

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

Additional information

The available study, following GLP and OECD Guideline 111, assessed the hydrolytic degradation of the test substance at 25 °C and under alkaline (pH 9), neutral (pH 7) and acidic (pH 4) conditions. A preliminary hydrolysis test was performed at 50 °C in aqueous solution at pH 4, 7 and 9. The mean residual rate of the test substance was at least 90% at all pH levels under the test conditions used in the present study (50 °C, 5 days). Therefore, the test substance was shown to be hydrolytically stable (DT50 (25 °C) > 1 year). On the basis of the results from the preliminary test, no further work was conducted.