P-1401

Hydrolysis

Link to relevant study record(s)

Reference

Reference 1

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:

OECD Guideline 111 (Hydrolysis as a Function of pH)

Deviations:

no

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Radiolabelling:

no

Analytical monitoring:

yes

Details on sampling:

Before and after incubation at 50 °C, 20 μL aliquots of the test solutions at each pH value were analysed without dilution by measuring the UV/VIS signal of the test substance after HPLC separation of the injected sample solution.

Buffers:

- pH: 4.0, 7.0, 9.0

Duration:

5 d

Temp.:

50 °C

Number of replicates:

Two aliquots of each test solution of approximately 50 mL each were transferred into 50 mL Erlenmeyer flasks in order to perform a duplicate test.

Transformation products:

no

Details on hydrolysis and appearance of transformation product(s):

The results of pH 4.0, pH 7.0 and pH 9.0 showed no significant degradation of the test substance at 50 ºC. The degradation of the test substance 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 ºC). Therefore, the test substance was considered to be hydrolytically stable, and no further testing was necessary.

Key result

Temp.:

50 °C

DT50:

> 1 yr

Validity criteria fulfilled:

yes

Conclusions:

The test substance is considered to be hydrolytically stable.

Executive summary:

The hydrolysis determination of the test substance at different pH values was based on the OECD Guideline No. 111, “Hydrolysis as a Function of pH”; adopted April 13, 2004 and on the EEC Directive 92/69, Section C.7, “Abiotic Degradation: Hydrolysis as a Function of pH”, L383 A, December 1992. The results of pH 4.0, pH 7.0 and pH 9.0 showed no significant degradation of the test substance at 50 °C. The degradation of the test substance was less than 10% after 5 days. According to the EEC Directive 92/69, Section C.7 it can be concluded, that the estimated halflife time is higher than one year under representative environmental conditions (25 °C). Therefore, the test substance is considered to be hydrolytically stable, and no further testing is necessary.

Reference 2

Endpoint:

hydrolysis

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Read-across from an analogue substance for which a guideline study (Klimish 1) is available.

Reason / purpose for cross-reference:

read-across source

Transformation products:

no

Remarks:

Results based on a read-across from an analogue substance.

Details on hydrolysis and appearance of transformation product(s):

Based on read-across approach from analogue substance, no significant degradation is expected at 50 ºC and at pH 4, 7 and 9. The estimated half-life time is > 1 year and therefore the substance is considered to be hydrolytically stable.

Key result

Temp.:

50 °C

DT50:

> 1 yr

Remarks on result:

other: Based on a read-acrossfrom an analogue substance.

Validity criteria fulfilled:

not applicable

Conclusions:

Based on read-across approach, the substance is considered to be hydrolytically stable.

Executive summary:

Based on experimental data on the analogue substance P0310 where there was no significant degradation at 50ºC, pH 4, 7, 9 and the half-life time was higher than one year (OECD Guideline 111 and GLP) the read-across approach is applied and the substance is also considered to be hydrolytically stable.

Description of key information

Key study: Read-across aproach from experimental data on P0310. Test method OECD 111. GLP study. The substance is considered to be hydrolitically stable at environmental conditions (25 ºC).

It should also take into account that the substance is manufactured and marketed in water solution and it is therefore regarded as hydrolytically stable.

Key value for chemical safety assessment

Half-life for hydrolysis:

1 yr

at the temperature of:

25 °C