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Hydrolysis

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Reference
Endpoint:
hydrolysis
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 2019-07-31 to 2019-12-24
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 111 (Hydrolysis as a Function of pH)
Version / remarks:
2004
Deviations:
yes
Remarks:
The average recovery rate of 0.5 mg/L at pH4.0, pH 7.0 and pH9.0 was a little exceeded the criteria, not affected the quality or integrity of the study
GLP compliance:
yes (incl. QA statement)
Specific details on test material used for the study:
Batch No.: 707001
Purity: 98.5%
Radiolabelling:
no
Analytical monitoring:
yes
Details on sampling:
Tier 1-preliminary test:
- at 50 ± 0.5°C: the residual concentrations from each vessel on the 5th day were determined.
- at 15 ± 0.5°C: the kinetic concentrations from each vessel on the 0, 2, 4, 6 and 24 hour were determined.
Buffers:
- pH: 4.0, 7.0, 9.0
- Composition of buffer:
pH4.0:500 mL 0.1mol/L potassium dihydrogen citrate + 90ml 0.1mol/L NaOH, to be dissolved in 1000 mL pure water;
pH7.0:500 mL 0.1mol/L KH2PO4+ 296.3ml 0.1mol/L NaOH, to be dissolved in 1000 mL pure water;
pH9.0:500 mL0.1mol/L boracic acid ( dissolved in 0.1mol/L KCl) + 213ml 0.1mol/L NaOH, to be dissolved in 1000 mL pure water.
Details on test conditions:
TEST SYSTEM
- Sterilisation method: All the buffer solutions and glass vessels used in this study were sterilized under 121°C for 20 min.

Tier 1-preliminary test
- at 50±0.5°C: 276 μL of stock solution of 1814 mg/L was added into 100 mL buffer solutions of pH4.0, pH7.0 and pH9.0, respectively, to generate a test solution of initial concentration 5 mg/L. And then the solution was divided in triplicates to be placed at 50±0.5°C in dark.
- at 15±0.5°C: 50 μL of stock solution of 1814 mg/L was added into 20 mL buffer solutions of pH4.0, pH7.0 and pH9.0, respectively, to generate a test solution of actual concentration 4.535 mg/L. Each pH condition was done in duplicates. And then the solutions were placed at 15±0.5°C in dark.
Duration:
5 d
pH:
4
Temp.:
50 °C
Initial conc. measured:
4.73 mg/L
Duration:
5 d
pH:
7
Temp.:
50 °C
Initial conc. measured:
4.018 mg/L
Duration:
5 d
pH:
9
Temp.:
50 °C
Initial conc. measured:
5.13 mg/L
Duration:
24 h
pH:
4
Temp.:
15 °C
Initial conc. measured:
4.798 mg/L
Duration:
24 h
pH:
7
Temp.:
15 °C
Initial conc. measured:
4.605 mg/L
Duration:
24 h
pH:
9
Temp.:
15 °C
Initial conc. measured:
4.535 mg/L
Number of replicates:
At 50±0.5°C: triplicates
At 15±0.5°C: duplicates
Positive controls:
no
Negative controls:
no
Preliminary study:
Tier 1-preliminary test at 50±0.5°C:
All samples in buffer solution of pH 4.0, 7.0 and 9.0 on the 5 day were much less than the LOQ, i.e. 0.5 mg/L, which indicated that the loss of test item was much more than 90% of initial concentration. This result indicated that the test item was not stable in buffer solutions.

Tier 1-preliminary test at 15±0.5°C:
The mean concentrations in buffer solution of pH 4.0, 7.0 and 9.0 on the 2 hour were < LOQ, 0.500 mg/L and
Transformation products:
not measured
Remarks on result:
not determinable
Remarks:
The test item was not stable due to high volatility and was independent on pH or temperature conditions.

In another test Adsorption-Desorption G1906A0030, the test item in the CaCl2/soil system was extremely unstable when agitation within 4 hours. In this test, the test item was also not able to be detected in buffer solutions within 6 hours even at 15°C. The volatility of test item from water phase can be referred as vapor pressure of 1860Pa at 25°C issued on Vapor report (CERI, study no.85300), which indicated the high volatility may lead to instability. In addition there might be not a function group that can react with H2O, hence the loss may not be expected to hydrolysis between test item and H2O.

Based on the results above, the hydrolysis test was considered as not suitable to the test item.The test item was not stable due to high volatility and was independent on pH or temperature conditions.

Validity criteria fulfilled:
not specified
Conclusions:
The hydrolysis test was considered as not suitable to the test item.The test item was not stable due to high volatility and was independent on pH or temperature conditions.
Executive summary:

A hydrolysis test was performed on the basis of OECD Guidelines No.111. The HPLC instrument was employed to determine the test item in buffer solution samples.

However, the test item was also not able to be detected in buffer solutions within 6 hours even at 15 °C. The volatility of test item from water phase can be referred as vapor pressure of 1860 Pa at 25 °C issued on Vapor report (CERI, study no.85300), which indicated the high volatility may lead to instability.In addition there might be not a function group that can react with H2O, hence the loss may not be expected to hydrolysis between test item and H2O.

The test item was not stable due to high volatility and was independent on pH or temperature conditions.

Description of key information

A hydrolysis test was performed on the basis of OECD Guidelines No.111.

The test item was not stable due to high volatility and was independent on pH or temperature conditions.

Key value for chemical safety assessment

Additional information

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