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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:
1996-05-03 to 1996-05-09
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Study performed following the test design of EU method C.7. No full study results reported.
Qualifier:
equivalent or similar to
Guideline:
EU Method C.7 (Degradation: Abiotic Degradation: Hydrolysis as a Function of pH)
Deviations:
not specified
Remarks:
full study results not reported
GLP compliance:
no
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Purity: 99+% (GC analysis)
- Analytical purity: 99+% (GC analysis)

OTHER SPECIFICS:
- Name of test material (as cited in study report): DMDEE
- Physical state: liquid
Radiolabelling:
no
Analytical monitoring:
yes
Details on sampling:
- Sampling intervals for the parent/transformation products: day 0 and day 5
- Sampling method: not indicated
- Sampling intervals/times for pH measurements: not indicated
- Sampling intervals/times for sterility check: not indicated
- Sample storage conditions before analysis: not indicated
Buffers:
- pH: 4, 7 and 9
- Type and final molarity of buffer: Britton-Robinson buffer; 0.4M of each of the below mentioned substances
- Composition of buffer: acetic acid, phosphoric acid and boric acid
Details on test conditions:
TEST SYSTEM
- Type, material and volume of test flasks, other equipment used: not reported
- Sterilisation method: not indicated
- Lighting: test vessels were stored in an oven at 50 - 55 degC
- Measures taken to avoid photolytic effects: not indicated
- Measures to exclude oxygen: not indicated
- If no traps were used, is the test system closed/open: not indicated
- Is there any indication of the test material adsorbing to the walls of the test apparatus? not indicated

TEST MEDIUM
- No details reported
Duration:
5 d
pH:
9
Initial conc. measured:
0.01 mol/L
Duration:
5 d
pH:
7
Initial conc. measured:
0.01 mol/L
Duration:
5 d
pH:
4
Initial conc. measured:
0.01 mol/L
Number of replicates:
Not reported
Positive controls:
not specified
Negative controls:
not specified
Statistical methods:
No statistical methods applied (no degradation observed).
Preliminary study:
The preliminary study showed no significant hydrolytical degradation of the test substance.
Transformation products:
no
Details on hydrolysis and appearance of transformation product(s):
The HPLC chromatograms showed no extraneous peaks.
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: not indicated (pH and temperature: only nominal)

TRANSFORMATION PRODUCTS
The HPLC chromatograms showed no extraneous peaks.
Validity criteria fulfilled:
not specified
Conclusions:
The test substance was concluded to be hydrolytically stable from a 5 days preliminary test at 50-55 °C and pH 4, 7 and 9.

Description of key information

The key value for hydrolysis was obtained from a 5-day test at pH 5, 7 and 9 and 50-55 °C.

Key value for chemical safety assessment

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

Additional information

The available study of Faske (1996) reported minimal experimental details but was found reliable with restrictions (K2). As the study showed no significant hydrolytical degradation, the test substance was considered hydrolytically stable. Therefore, the extrapolated half-life time at 25 °C is concluded to be > 1 year.