Reaction mass of (disodium 4-[[4-(acetylmethylamino)-2-sulphonatophenyl]amino]1-amino-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate and sodium sulphate and sodium chloride)

Hydrolysis

Link to relevant study record(s)

Reference

Endpoint:

hydrolysis

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2018-05-30 to 2018-07-12

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)

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

Name: Reaction mass of disodium 4-[[4-acetylmethylamino)-2-sulfonatophenyl]amino]-1-amino-9,10-dihydro-9,10-dioxoanthracene-2-sulfonate and sodium sulphate and sodium chloride
Batch No.: CHA0 122490
Certificate of Analysis / Date: February 12, 2015
EC 944-710-7
Physical Appearance / Colour: Dark blue powder
Expiry Date: February 12, 2025
Storage Conditions at Test Facility: At 20°C ± 5°C, in the dark

Radiolabelling:

no

Analytical monitoring:

yes

Details on sampling:

Preliminary Test (Tier 1)
Test Duration: The incubation was terminated after 5 days.
Sampling of the Test Samples: pH 4, 7 and 9: 0, 3, 24, 120 h
At each sampling point, samples were taken in duplicate.

Buffers:

Sterile aqueous solutions buffered at pH 4, 7 and 9.
The pH of each buffer solution was measured with a calibrated pH meter.
pH 4: 0.05 M phthalate buffer
20 mL NaOH (0.1 M) was added to 250 mL potassium dihydrogenphosphate (0.1 M). The solution was filled up to 500 mL with pure water.
pH 7: 0.05 M phosphate buffer
148 mL NaOH (0.1 M) was added to 250 mL potassium dihydrogenphosphate (0.1 M). The solution was filled up to 500 mL with pure water.
pH 9: 0.05 M boric acid buffer
106.5 mL NaOH (0.1 M) was added to 250 mL of a solution of boric acid (0.1 M) in potassium chloride (0.1 M). The solution was filled up to 500 mL with pure water.

Details on test conditions:

50 °C ± 0.1 °C
Anoxic Conditions: To avoid oxidation the buffer solutions were purged with inert gas (nitrogen) prior to sterilisation.
Sterile Conditions: Degased buffer solutions and the used glassware were sterilised using an autoclave (20 min at 121°C) prior to application.

Duration:

5 d

pH:

4

Temp.:

50 °C

Initial conc. measured:

20 mg/L

Remarks:

99.5% recovery

Duration:

5 d

pH:

7

Temp.:

50 °C

Initial conc. measured:

20 mg/L

Remarks:

99.3% recovery

Duration:

5 d

pH:

9

Temp.:

50 °C

Initial conc. measured:

20 mg/L

Remarks:

99.3% recovery

Number of replicates:

Two samples of solutions of each pH value were taken at each sampling point.

Positive controls:

no

Negative controls:

no

Preliminary study:

Samples were incubated at three different pH-values and at one temperature. The test was carried out for 5 days. During incubation the concentration of the test item remained stable at each tested pH-value of 4, 7 and 9. Recoveries (mean) were in the range of 99.3-100.3% of the nominal applied concentration. Thus the test item can be stated as hydrolytically stable. The main test (Tier 2) was not performed.

Transformation products:

no

% Recovery:

99.6

pH:

4

Temp.:

50 °C

Duration:

5 d

% Recovery:

100

pH:

7

Temp.:

50 °C

Duration:

5 d

% Recovery:

100.3

pH:

9

Temp.:

50 °C

Duration:

5 d

Key result

Remarks on result:

hydrolytically stable based on preliminary test

Validity criteria fulfilled:

yes

Remarks:

Immediately after application (0 h) recoveries (mean) of the samples were as follows: 99.3-99.5% of the nominal applied concentration.

Conclusions:

The present study investigated the hydrolytic behaviour of the test item in aqueous solutions buffered at pH 4, 7 and 9 and at one elevated temperature. Samples were incubated in the dark. The test was carried out for 5 days. At the end of incubation, 99.6-100.3% of the nominal applied concentration were found and thus the test item can be stated as hydrolytically stable (t0.5 > 1 year at 25°C).

Executive summary:

Test Item: Acid Blue 182

Guidelines/Recommendations:This study was based on the procedures indicated by the following internationally accepted guidelines and recommendations:

 OECD Guideline for Testing of Chemicals No. 111: "Hydrolysis as a function of pH", adopted April 13, 2004.

GLP: Yes (certified laboratory)

Purpose: The purpose of the study was to determine the rate of hydrolysis of Acid BLue 182 at different environmentally relevant pH-values and at different temperatures.

Test Setup:

Test Vessels: Glass flasks were used for the test.

Aqueous Solution: Sterile aqueous solutions buffered at pH 4, 7 and 9.

Test Conditions: In the dark at,Preliminary test (Tier 1): 50°C ± 0.1°C

Treatment Rate: Preliminary test (Tier 1): 20.1 and 20.3 mg/L (two individual replicates)

Results:               

The present study investigated the hydrolytic behaviour of the test item in aqueous solutions buffered at pH 4, 7 and 9 and at one elevated temperature. Samples were incubated in the dark. The test was carried out for 5 days. At the end of incubation, 99.6-100.3% of the nominal applied concentration were found and thus the test item can be stated as hydrolytically stable (t0.5 > 1 year at 25°C).

This study is classified acceptable and satisfies the guideline requirements for hydrolysis studies.

Description of key information

OECD 111

The present study investigated the hydrolytic behaviour of the test item in aqueous solutions buffered at pH 4, 7 and 9 and at one elevated temperature. Samples were incubated in the dark. The test was carried out for 5 days. At the end of incubation, 99.6-100.3% of the nominal applied concentration were found and thus the test item can be stated as hydrolytically stable (t0.5 > 1 year at 25°C).