2-hydroxy-1-[4-[4-(2-hydroxy-2-methylpropanoyl)phenoxy]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

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

Annex V, C.7

GLP compliance:

yes

Preliminary study:

The result of preliminary test showed that less than 50% of ESACURE 2006 has been hydrolysed in 2.5 hours at 50°C, and less than 10% has been hydrolysed after 5 days, for the three pH values (4.0, 7.0 and 9.0) tested. No full test was performed in according with the methodology. Finally ESACURE 2006 can be considered with an abiotic degradation hydrolysis lower than 10% after 5 days at 50°C for pH 4.0, pH 7.0 and pH 9.0.

Transformation products:

no

Key result

pH:

4

Temp.:

50 °C

DT50:

5 d

Remarks on result:

hydrolytically stable based on preliminary test

Key result

pH:

7

Temp.:

50 °C

DT50:

5 d

Remarks on result:

hydrolytically stable based on preliminary test

Key result

pH:

9

Temp.:

50 °C

DT50:

5 d

Remarks on result:

hydrolytically stable based on preliminary test

Details on results:

At all pH, there was less than 10% hydrolysis of the test substance

Conclusions:

Based on the results of the study, the test substance is considered to be hydrolytically stable.

Executive summary:

A study was conducted to evaluate the rate of hydrolysis of the test substance as a function of pH according to EU Method C.7, in compliance with GLP. The hydrolytic stability was investigated in buffer solutions of pH 4, 7 and 9 in a water bath at 50ºC for 5 days. Samples were taken at t0 and at regular intervals afterwards to determine half-life (t½). According to the guideline, if t½ is less than 2.4 h, or if less than 10% of the test substance is hydrolysed in 5 d, no further tests need to be performed at that pH. Under the conditions of the study, after 5 days at 50°C, less than 10% decrease in test substance concentration was measured at all three pH values. Therefore, the test substance was concluded to be hydrolytically stable with a half-life equal to or greater than one year at pH 4, 7 and 9 at ambient temperature (ChemService, 2007). 

Description of key information

Based on the results of the study, the test substance is considered to be hydrolytically stable.

Additional information

A study was conducted to evaluate the rate of hydrolysis of the test substance as a function of pH according to EU Method C.7, in compliance with GLP. The hydrolytic stability was investigated in buffer solutions of pH 4, 7 and 9 in a water bath at 50ºC for 5 days. Samples were taken at t0 and at regular intervals afterwards to determine half-life (t½). According to the guideline, if t½ is less than 2.4 h, or if less than 10% of the test substance is hydrolysed in 5 d, no further tests need to be performed at that pH. Under the conditions of the study, after 5 days at 50°C, less than 10% decrease in test substance concentration was measured at all three pH values. Therefore, the test substance was concluded to be hydrolytically stable with a half-life equal to or greater than one year at pH 4, 7 and 9 at ambient temperature (ChemService, 2007).