2-hydroxy-1-(4-(4-(2-hydroxy-2-methylpropionyl)benzyl)phenyl)-2-methylpropan-1-one

Hydrolysis

Link to relevant study record(s)

Reference

Endpoint:

hydrolysis

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2003-01-27 to 2003-06-03

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:

adopted May 12,1981

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method C.7 (Degradation: Abiotic Degradation: Hydrolysis as a Function of pH)

Version / remarks:

adopted December 1992

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Radiolabelling:

no

Analytical monitoring:

yes

Details on sampling:

- Sampling intervals for the parent/transformation products: Analysis was performed with aliquots taken before incubation, after 2.4 hours and after 120 hours.
- Sampling intervals/times for pH measurements: yes (at each pH value)

Buffers:

- pH: 4, 7, 9
- Composition of buffer:
pH4.0:
13.96 mg of the test item were dissolved In 100 mL buffer solution (pH 4.0) containing 2 % acetonitrile as solubilizer. This mixture was ultrasonified for 10 minutes and submitted to a 0.2 µm filtration. To obtain a test solution of not more than half the water solubility, the solution was diluted 1:1 with the respective buffer. Two aliquots of this test solution of approximately 50 mL each were transferred into 50 mL Erlenmeyer flasks in order to perform a duplicate test.
pH7.0:
13.93 mg of the test item were dissolved in 100 mL buffer solution (pH 7.0) containing 2 % acetonitrile as solubilizer. This mixture was ultrasonified for 10 minutes and submitted to a 0.2 µm filtration. To obtain a test solution of not more than half the water solubility, the solution was diluted 1:1 with the respective buffer. Two aliquots of this test solution of approximately 50 mL each were transferred into 50 mL Erlenmeyer flasks in order to perform a duplicate test.
pH9.0:
13.45 mg of test item were dissolved in 100 mL buffer solution (pH 9.0) containing 2 % acetonitrile as solubilizer. This mixture was ultrasonified for 10 minutes and submitted to a 0.2 µm filtration. To obtain a test solution of not more than half the water solubility, the solution was diluted 1:1 with the respective buffer. Two aliquots of this test solution of approximately 50 mL each were transferred into 50 mL Erlenmeyer flasks in order to perform a duplicate test.

Details on test conditions:

TEST SYSTEM
- Type, material and volume of test flasks, other equipment used: Three preliminary tests were performed at 50°C ± 0.5°C at each of pH 4.0, pH 7.0 and pH 9.0.
- Lighting: In total three tests were performed. The first and the second test were performed under normal daylight. Probably due to the light sensitivity of the test item, the content of test item found in the sample solutions showed high differences. Therefore,a third preliminary test was performed under red-light.

Duration:

5 d

pH:

4

Temp.:

50 °C

Initial conc. measured:

>= 19.67 - <= 20.47 mg/L

Duration:

5 d

pH:

7

Temp.:

50 °C

Initial conc. measured:

>= 10.68 - <= 10.79 mg/L

Duration:

5 d

pH:

9

Temp.:

50 °C

Initial conc. measured:

>= 19.36 - <= 20.38 mg/L

Number of replicates:

2

Positive controls:

no

Negative controls:

no

Preliminary study:

The results of pH 4.0, pH 7.0 and pH 9.0 showed no significant degradation of the test item at 50°C. The degradation of the test item was less than 10 % after 5 days. According to the EEC Directive 92/69, Section C.7, it can be concluded, that the estimated half-life time is higher than one year under representative environmental conditions (25°C). Therefore, the test item was considered to be hydrolytically stable, and no further testing was necessary.

Transformation products:

not specified

% Recovery:

< 10

pH:

4

Temp.:

50 °C

Duration:

5 d

% Recovery:

< 10

pH:

7

Temp.:

50 °C

Duration:

5 d

% Recovery:

< 10

pH:

9

Temp.:

50 °C

Duration:

5 d

Key result

Remarks on result:

hydrolytically stable based on preliminary test

Validity criteria fulfilled:

not applicable

Remarks:

Conclusion based upon preliminary result.

Conclusions:

The test material was determined to be hydrolytically stable based upon the preliminary result.

Executive summary:

In this guideline (OECD 111) study conducted with GLP certification, the test material (EC 444-860-9) was determined to be hydrolytically stable.

Description of key information

In contact with water the substance is considered to be hydrolytically stable.

The potential of the test substance to hydrolyse was investigated in a GLP study according to OECD guideline 111. The results of pH 4.0, pH 7.0 and pH 9.0 showed no significant degradation at 50°C (< 10 % after 5 days) (RCC Ltd. 2003). According to the EEC Directive 92/69, Section C.7, it can be concluded, that the estimated half-life time is higher than one year under representative environmental conditions (25°C). Therefore, the test item was considered to be hydrolytically stable, and no further testing was necessary.

Key value for chemical safety assessment

Half-life for hydrolysis:

1 yr

at the temperature of:

50 °C

Additional information

Study conducted to recognised testing guidelines with GLP certification.