[No public or meaningful name is available]

Hydrolysis

Link to relevant study record(s)

Reference

Endpoint:

hydrolysis

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2021-10-29 to 2022-03-15

Reliability:

1 (reliable without restriction)

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

2008

Deviations:

no

Qualifier:

according to guideline

Guideline:

OECD Guideline 111 (Hydrolysis as a Function of pH)

Version / remarks:

2004

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

yes

Details on sampling:

Samples were taken at test start (0 h) and test end (120 h). The samples were stabilized with 5 mL acetonitrile containing 0.2% formic acid at sampling (dilution factor 2).

Buffers:

- pH: 4
- Type of buffer: sodium hydroxide with mono potassium citrate

- pH: 7
- Type of buffer: ammonium acetate buffer

- pH: 9
- Type of buffer: sodium hydroxide with potassium chloride and boric acid

with Purified water (sterilized) as co-solvent

Details on test conditions:

The test solutions were prepared at test start via stock solution. 4.95 mL of the sterile buffer solution were given into the test container. The test container was carefully spiked with 0.05 mL of stock solution. Afterwards, the vials were sealed immediately and shaken for homogenization. After the vials were sealed, they were transferred into the thermostat. The time between test item application and transfer to thermostat / analysis did not exceed 30 min.

Incubation time: 120 h

Photolytic effects were avoided by using an opaque water bath.

Samples were taken at test start (0 h) and test end (120 h). The samples were stabilized with 5 mL acetonitrile containing 0.2% formic acid at sampling (dilution factor 2). All test item containing samples were analyzed immediately (if possible less than 30 min until start of analyses, but at least not more than 2.5% of the total study time) with the analytical method acc. To part 13. The method was validated acc. to SANTE/2020/12830, Rev.1 with the parameters specified in part 14. The method validation procedure was not part of this GLP study. The incubation temperature was checked automatically once per hour and at least once per day manually.

Duration:

120 h

pH:

4

Temp.:

50 °C

Initial conc. measured:

21 mg/L

Duration:

120 h

pH:

7

Temp.:

50 °C

Initial conc. measured:

20.8 mg/L

Duration:

120 h

pH:

9

Temp.:

50 °C

Initial conc. measured:

20.8 mg/L

Number of replicates:

Duplicates per pH and sampling date, single injections

Positive controls:

no

Negative controls:

no

Remarks:

Buffer solutions (pH value 4, 7 and 9) and co-solvent

Preliminary study:

Preliminary hydrolysis test for the determination of the stability of the test item in buffered, aqueous solution (pH 4, 7, 9).

Transformation products:

not measured

Remarks:

The test item Dibuthyltetraalkylguanidinium chloride was found to be hydrolytically stable at all pH conditions.

Key result

Remarks on result:

hydrolytically stable based on preliminary test

Validity criteria fulfilled:

yes

Conclusions:

The test item Dibuthyltetraalkylguanidinium chloride was found to be hydrolytically stable at all
pH conditions.

Executive summary:

The test item Dibuthyltetraalkylguanidinium chloride was found to be hydrolytically stable at all pH conditions.

Description of key information

According to to OECD Guideline No. 111 (2004) and Council Regulation (EC) No. 440/2008, Method C.7. The test item Dibuthyltetraalkylguanidinium chloride was found to be hydrolytically stable at all pH conditions.