Ethanone, 1-(1-chlorocyclopropyl)-

Hydrolysis

Link to relevant study record(s)

Reference

Endpoint:

hydrolysis

Type of information:

experimental study

Adequacy of study:

key study

Study period:

27 Jul - 19 Okt 2001

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Remarks:

Nevertheless, the experimental study was conducted according to EEC Method (92/69/EEC C.7) and is GLP compliant. Results of the preliminary test showed that the test substance is hydrolytically stable as less than 10% were degraded within 5 days at pH 4, 7 and 9. Therefore, the results are considered reliable.

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

92/69

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Radiolabelling:

no

Analytical monitoring:

yes

Buffers:

At pH value = 9 and 50 °C:
buffer: borax / hydrochloric acid,
Riedel de Haen Art. No. 33548, ready to use solution

At pH value = 7 and 50 °C:
buffer: potassium dihydrogen phosphate / Di-sodium hydrogen phosphate,
Riedel de Haen Art. No. 33546, ready to use solution

At pH value = 4 and 50 °C:
buffer: citric acid / potassium hydroxide / sodium chloride,
Riedel de Haen Art. No. 33543, ready to use solution

Preliminary study:

At pH value = 9 and 50 °C:
Within five days the degradation was less than 10 %.

At pH value = 7 and 50 °C:
Within five days the degradation was less than 10 %.

At pH value = 4 and 50 °C:
Within five days the degradation was less than 10 %.

Transformation products:

no

% Recovery:

> 90

pH:

4

Temp.:

50 °C

Duration:

5 d

Remarks on result:

hydrolytically stable based on preliminary test

% Recovery:

> 90

pH:

7

Temp.:

50 °C

Duration:

5 d

Remarks on result:

hydrolytically stable based on preliminary test

% Recovery:

> 90

pH:

9

Temp.:

50 °C

Duration:

5 d

Remarks on result:

hydrolytically stable based on preliminary test

Remarks on result:

hydrolytically stable based on preliminary test

Target condition according to  guideline:	Actual condition according to  the study:	Validity criteria met:
The analytical method must be sufficiently precise and sensitive to detect a reduction of 10 % of the initial concentration.	Analysis via HPLC is sensitive enough to detect a reduction of 10% of the initial concentration.	Yes
Test 1: A sufficient number of samples (not less than four) should be chosen to cover the range 20 to 70 % of hydrolysis to test for pseudo-first order behaviour at the specified pH values.	Within five days the degradation was less than 10 %. If the preliminary test indicates that less than 10 % has been hydrolyzed after five days at each of the  three pH values (4, 7 and 9), no further testing is necessary.	Yes
For each test: the temperature, pH value, buffer composition and a table of all concentration-time data points shall be stated.	The temperature, pH value, buffer composition and a table of all concentration-time data points are not stated. Nevertheless, the study is GLP compliant including a QA statement. Results of the preliminary test showed that the test substance is hydrolytically stable as less than 10% were degraded within 5 days at pH 4, 7 and 9. Therefore, the results are considered reliable.	No

Validity criteria fulfilled:

no

Remarks:

See "Any other information on results incl. tables"

Conclusions:

Within five days the degradation was less than 10 % at pH = 4, 7, 9 at 50 °C.

Executive summary:

The experimental protocol is comparable to preliminary test of the EU method C.7 (Degradation: Hydrolysis as a function of pH). Aliquots of the dilutions were taken and tempered at 50°C for 5 days. The solutions were analysed by HPLC. The experiments using buffers at pH 4, pH 7 and pH 9 showed that the test substance is not degradable in contact with water.  Within five days the degradation was less than 10 %.

Description of key information

The experimental protocol is comparable to preliminary test of the EU method C.7 (Degradation: Hydrolysis as a function of pH). Aliquots of the dilutions were taken and tempered at 50°C for 5 days. The solutions were analysed by HPLC. The experiments using buffers at pH 4, pH 7 and pH 9 showed that the test substance is not degradable in contact with water.  Within five days the degradation was less than 10 %.