1,4-bis(methoxymethyl)benzene

Hydrolysis

Link to relevant study record(s)

Reference

Endpoint:

hydrolysis

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 2020-12-09 to 2020-12-14

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

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

Batch No.: G0508
Purity: 99.86%

Analytical monitoring:

yes

Details on sampling:

- Sampling intervals for the parent: The initial concentration of test item was analyzed immediately after preparation in triplicates, the concentration on the 5th day was also analyzed in triplicates.
- Sampling method: About 1.5 mL solution was taken and filtered by 0.45 μm membrane prior to being determined by HPLC. Each vessel was randomly taken three samples in total.

Buffers:

- pH: 4.0, 7.0 and 9.0
- Type and final molarity of buffer: Sterilized buffer solution
- Composition of buffer:
pH 4.0：500 mL 0.1 mol/L potassium dihydrogen citrate + 90 mL 0.1 mol/L NaOH, to be dissolved to 1000 mL by pure water;
pH 7.0：500 mL 0.1 mol/L KH2PO4+ 296.3 mL 0.1 mol/L NaOH, to be dissolved to 1000 mL by pure water;
pH 9.0：500 mL 0.1 mol/L boracic acid (dissolved in 0.1 mol/L KCl) + 213 mL 0.1 mol/L NaOH, to be dissolved to 1000 mL by pure water.

Details on test conditions:

TEST SYSTEM
- Type, material and volume of test flasks, other equipment used: glass vessels, Constant Temperature Incubator
- Sterilisation method: sterilized beforehand under 121℃ for 30 min.
- Measures taken to avoid photolytic effects: incubated in dark
- Test procedure:
Tier 1-preliminary test: 10.0 mL buffer solution at pH 4.0, 7.0 and 9.0 spiked with 100 µL of stock solution of 1000 mg/L was vertexed for about 30 seconds to generate a test solution of 10 mg/L in glass vessel. Then the vessels were uprightly placed in a constant incubator at 50±0.5℃ in dark.

Duration:

5 d

pH:

9

Temp.:

50 °C

Initial conc. measured:

9.725 mg/L

Duration:

5 d

pH:

7

Temp.:

50 °C

Initial conc. measured:

9.764 mg/L

Duration:

5 d

pH:

4

Temp.:

50 °C

Initial conc. measured:

9.679 mg/L

Number of replicates:

3

Preliminary study:

Because hydrolysis percentage under 50±0.5℃ was less than 10%, the test item can be considered as chemically stable (i.e. DT50>1 year at 25℃). The definite test was terminated.

Transformation products:

not measured

pH:

9

Temp.:

25 °C

DT50:

> 1 yr

pH:

7

Temp.:

25 °C

DT50:

> 1 yr

pH:

4

Temp.:

25 °C

DT50:

> 1 yr

Details on results:

The average concentration of pH 4.0, 7.0, 9.0 buffer solution on the time 0 was 9.679 mg/L, 9.764 mg/L and 9.725 mg/L, respectively; which represented 96.8%, 97.6% and 97.3% accuracy of nominal concentration.
While on the 5th day, the residual concentration of pH 4.0, 7.0, 9.0 buffer solution was 9.188 mg/L, 9.939 mg/L and 9.262 mg/L, respectively; which represented hydrolysis percentage was 5.1%, 3.8% and 4.8% only.

Conclusions:

The test item can be considered as chemically stable in hydrolysis.

Executive summary:

This test was performed according to the OECD Guideline No.111: Hydrolysis as a function of pH.

A preliminary test under 50±0.5℃ was performed firstly. The average concentration of pH 4.0, 7.0, 9.0 buffer solution on the time 0 was 9.679 mg/L, 9.764 mg/L and 9.725 mg/L, respectively. While on the 5th day, the residual concentration of pH 4.0, 7.0, 9.0 buffer solution was 9.188 mg/L, 9.939 mg/L and 9.262 mg/L, respectively; which represented hydrolysis percentage was 5.1%, 3.8% and 4.8% only. Because hydrolysis percentage under 50 ± 0.5℃ was less than 10%, the test item can be considered as chemically stable (i.e. DT₅₀>1 year at 25℃). The definite test was terminated.

Description of key information

This hydrolysis test was performed according to the OECD 111.

A preliminary test under 50±0.5℃ was performed firstly.

Because hydrolysis percentage under 50±0.5℃ was less than 10%, the test item can be considered as chemically stable (i.e. DT₅₀>1 year at 25℃). The definite test was terminated.

Key value for chemical safety assessment

Half-life for hydrolysis:

1 yr

at the temperature of:

25 °C