Reaction product of alkylarylsulphonic acid and cycloaliphatic amine

Hydrolysis

Link to relevant study record(s)

Reference

Endpoint:

hydrolysis

Type of information:

experimental study

Adequacy of study:

key study

Study period:

24 December 2015 to 08 March 2016

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)

Qualifier:

according to guideline

Guideline:

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

Qualifier:

according to guideline

Guideline:

EPA OPPTS 835.2120 (Hydrolysis of Parent and Degradates as a Function of pH at 25°C)

Principles of method if other than guideline:

Only a preliminary test was performed.

GLP compliance:

yes

Radiolabelling:

no

Analytical monitoring:

yes

Details on sampling:

- Sampling intervals for the parent products: at start and day 5
- Sampling method: in duplicate
- Sampling intervals/times for pH measurements: at start and day 5
- Sample storage conditions before analysis: analyzed immediately

Buffers:

Acetate buffer pH 4, 0.01 M:
solution of 16.7% (v/v) 0.01 M sodium acetate in water and 83.3% (v/v) 0.01 M acetic acid in water. The buffer contains 0.0009% (w/v) sodium azide.
Phosphate buffer pH 7, 0.01 M:
solution of 0.01 M potassium di-hydrogenphosphate in water adjusted to pH 7 using 1 N sodium hydroxide. The buffer contains 0.0009% (w/v) sodium azide.
Borate buffer pH 9, 0.01 M :
solution of 0.01 M boric acid in water and 0.01 M potassium chloride in water adjusted to pH 9 using 1 N sodium hydroxide. The buffer contains 0.0009% (w/v) sodium azide

Details on test conditions:

TEST SYSTEM
- Type, material and volume of test flasks, other equipment used: sterile vessel containing 6 mL test solution
- Sterilisation method: filter-sterilised through a 0.2 µm FP 30/0.2 CA-S filter (Whatman, Dassel, Germany)
- Lighting: in dark (all test solutions were protected from light at any time)
- Measures to exclude oxygen: nitrogen gas purged through solution
- Is there any indication of the test material adsorbing to the walls of the test apparatus; no
- Test temperature: 50.0°C ± 0.1°C
TEST MEDIUM
- Volume used/treatment: 6 mL (1.00 mg/L)
- Kind and purity of water: milli-Q water
- Preparation of test medium: sterilised through a 0.2 um filter

Number of replicates:

2 replicates/ pH-value

Positive controls:

no

Negative controls:

not specified

Remarks:

blanks were included but not reported

Statistical methods:

NA

Preliminary study:

Hydrolysis was < 10% at all pH values. The concomittant t1/2 is > 1 year at 25 °C

Test performance:

In view of the results of the preliminary study no further tests were performed

Transformation products:

not measured

% Recovery:

96.4

pH:

4

Temp.:

50 °C

Duration:

5 d

Remarks on result:

hydrolytically stable based on preliminary test

% Recovery:

91.1

pH:

7

Temp.:

50 °C

Duration:

5 d

Remarks on result:

hydrolytically stable based on preliminary test

% Recovery:

102.4

pH:

9

Temp.:

50 °C

Duration:

5 d

Remarks on result:

hydrolytically stable based on preliminary test

pH:

4

Remarks on result:

hydrolytically stable based on preliminary test

pH:

7

Remarks on result:

hydrolytically stable based on preliminary test

pH:

9

Remarks on result:

hydrolytically stable based on preliminary test

Preliminary hydrolysis test of the test substance at pH 4, pH 7 and pH 9

pH code Sampling time Analysed concentration [mg/L] Degree of hydrolysis [%] Actual pH Individual Mean             pH 4 0 hours 0.983     4.0     1.01     4.1               5 days 0.948 4.7 3.6 4.1     0.972 2.4   4.1             pH 7 0 hours 1.04     7.0     1.03     7.0               5 days 0.936 9.7 8.9 7.0     0.952 8.2   7.0             pH 9 0 hours 1.00     8.9     0.998     8.9               5 days 1.02 -2.6 -2.4 8.9     1.02 -2.2   8.9

Validity criteria fulfilled:

yes

Conclusions:

The hydrolysis rate of the substance at pH 4, 7 and 9 is >1 year

Executive summary:

In a hydrolysis study performed according to OECD 111, the preliminary test at pH 4, 7 and 9 showed hydrolysis < 10% at 50 °C over the 5 day test period..

It can therefore be concluded that the hydrolysis rate of the substance at all tested pH values is > 1 year.

Description of key information

In a hydrolysis study performed according to OECD 111, the preliminary test at pH 4, 7 and 9 showed hydrolysis < 10% at 50 °C over the 5 day test period..

The substance is considered hydrolytically stable.

Key value for chemical safety assessment

Half-life for hydrolysis:

1 yr

at the temperature of:

25 °C