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Hydrolysis

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Reference
Endpoint:
hydrolysis
Type of information:
experimental study
Adequacy of study:
key study
Study period:
09 October 2003 - 17 October 2003
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
Validation details for the analytical method applied were not reported.
Qualifier:
according to guideline
Guideline:
EU Method C.7 (Degradation: Abiotic Degradation: Hydrolysis as a Function of pH)
GLP compliance:
yes
Specific details on test material used for the study:
- Batch: 8191-34
- Purity: 97.8% (expressed as primary amine, % of total)
Radiolabelling:
no
Analytical monitoring:
yes
Details on sampling:
- Sampling intervals for the parent/transformation products: at t = 0h, 2.4h and 5 days
- Sampling method: not indicated
- Sampling methods for the volatile compounds, if any: not applicable
- Sampling intervals/times for pH measurements: 0h, 2.4h and 5 days
- Sampling intervals/times for sterility check: no sterility check
- Sample storage conditions before analysis: not indicated
- Other observation, if any (e.g.: precipitation, color change etc.): none indicated
Buffers:
- pH: 4, 7 and 9
- Type and final molarity of buffer: 0.05 M acetate / 0.05 M phosphate / 0.05 M borate
- Composition of buffer: sodium acetate / acetic acid (pH 4); potassium dihydrogen phosphate / sodium hydroxide (pH 7); boric acid / potassium chloride / sodium hydroxide (pH 9)
Details on test conditions:
TEST SYSTEM
- Type, material and volume of test flasks, other equipment used: 50 mL volumetric flasks
- Sterilisation method: filter sterilized over 0.2 microm membrane filter
- Lighting: light was excluded
- Measures taken to avoid photolytic effects: study was performed in the dark (not further specified)
- Measures to exclude oxygen: nitrogen gas was bubbled through the test solutions (for 5 min)
- Details on test procedure for unstable compounds: not applicable
- Details of traps for volatile, if any: no traps for volatiles included in the test design
- If no traps were used, is the test system closed/open: closed (vessels were tightly sealed with a septum-crimpcap)
- Is there any indication of the test material adsorbing to the walls of the test apparatus? Not reported
TEST MEDIUM
- Volume used/treatment: 50 mL
- Kind and purity of water: tap water purified by reversed osmosis and subsequently passed over activated carbon and ion-exchange cartridges
- Preparation of test medium: filter sterilized over 0.2 microm membrane filter; 9.20 - 10.4 mg substance per 50 mL medium
- Renewal of test solution: no renewal of test solutions
- Identity and concentration of co-solvent: no co-solvent applied
OTHER TEST CONDITIONS
- Adjustment of pH: pH not adjusted
- Dissolved oxygen: not measured
Duration:
5 d
pH:
4
Temp.:
50 °C
Initial conc. measured:
161 mg/L
Duration:
5 d
pH:
7.2
Temp.:
50 °C
Initial conc. measured:
200 mg/L
Duration:
5 d
pH:
9.1
Temp.:
50 °C
Initial conc. measured:
173 mg/L
Number of replicates:
Each pH was tested in a single experiment
Positive controls:
no
Negative controls:
no
Statistical methods:
No statistical methods used
Preliminary study:
The pH was measured to be 4.0 /4.0 / 4.2, 7.2/7.2/7.2 and 9.1/9.0/9.1 after 0h, 2.4h and 5 days. The submission substance appeared to be stable under the test conditions. A main study was thus concluded not to be required.
Test performance:
No validation results and example HPLC chromatograms were provided. The results of the sample measurements indicate a significant spread in the analytical results; for instance at pH 9 the 0h, 2.4h and 5 days results were 173 mg/L, 147 mg/L and 207 mg/L, respectively. Results should thus be treated with care.
Transformation products:
no
Key result
pH:
4
Temp.:
50 °C
DT50:
> 8 760 h
Remarks on result:
other: Temp.: CA 50 °C
Key result
pH:
7
Temp.:
50 °C
DT50:
> 8 760 h
Remarks on result:
other: Temp.: CA 50 °C
Key result
pH:
9
Temp.:
50 °C
DT50:
> 8 760 h
Remarks on result:
other: Temp.: CA 50 °C
Details on results:
TEST CONDITIONS
- pH, sterility, temperature, and other experimental conditions maintained throughout the study: Yes (sterility not checked)
- Anomalies or problems encountered (if yes): significant spread in analytical results, see "Results and discussion".

MAJOR TRANSFORMATION PRODUCTS: no transformation products
Validity criteria fulfilled:
not specified
Conclusions:
The substance is concluded to be hydrolytically stable at pH 4, 7 and 9 (half-life time at 25 °C > 1 year).

Description of key information

The substance was determined to be hydrolytically stable at pH 4, 7 and 9 (extrapolated half-life time at 25 °C > 1 year) in a GLP study according to test method EC C.7 (Baltussen, 2004). This Klimisch 2 study is considered as the key study.

Key value for chemical safety assessment

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

Additional information

A single study is available on hydrolysis (Baltussen, 2004). As the substance appeared to be hydrolytically stable in the preliminary test, the extrapolated half-life time at 25 °C is concluded to be > 1 year. This study is a well performed GLP study in accordance with accepted test guidelines. Validation details for the analytical method applied were not reported and therefore the study was assigned a Klimisch 2 score.