Tetrasodium 2,2''-diamino-8,8''-dihydroxy-4',4'''-{4-[bis(2-hydroxyethyl)amino]-1,3,5-triazine-2,6-diyldiimino}bis(naphthalene-1-azobenzene-2',6-disulfonate)

Hydrolysis

Administrative data

Endpoint:

hydrolysis

Type of information:

experimental study

Adequacy of study:

key study

Study period:

September 12th to 23rd, 2002

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

92/69/EEC

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 111 (Hydrolysis as a Function of pH)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Red LF 6339

IUPAC Name:

Red LF 6339

Study design

Analytical monitoring:

yes

Details on sampling:

Analysis was performed before incubation, after 2.4 hours and after 120 hours

Buffers:

- pH: 4, 7, 9
- Composition of buffer: Buffer pH4, Bipthalate; Buffer pH 7, Phosphate; Buffer ph 9, Borate

Details on test conditions:

TEST SYSTEM
- Type, material and volume of test flasks, other equipment used: Erlenmeyer flasks 50 ml
- Sterilisation method: all glassware rinsed with sterile buffer

Preliminary test
performed at 50 °C ± 0.5 °C at each of pH 4.0, 7.0 and pH 9.0. Aliquots of each test solution were analysed in time intervals using the analytical method.
A main study was not performed since the test item was found a stable according to the criteria given in the guideline.

Preparation of test solutions
pH 4.0: a 9.40 mg sample was dissolved in 100 ml buffer solution (pH 4.0) with aid of sonication to prepare a test solution of 94.0 μg/ml test material. Two aliquots of this test solution of approximately 50 ml each were transferred into 50 ml Erlenmeyer flasks in order to perform a duplicate test.
pH 7.0: a 14.52 mg sample of test material was dissolved in a 100 ml buffer solution (pH 7.0) with aid of sonication to prepate a test solution of 145.2 μg/ml test substance. Two aliquots of this test solutio of app 50 ml each were transferred into 50 ml Erlenmeyer flasks in order to perform a duplicate test.
pH 9.0: a 10.15 mg sample of test material was dissolved in a 100 ml buffer solution (pH 9.0) with aid of sonication to prepate a test solution of 101.5 μg/ml test substance. Two aliquots of this test solutio of app 50 ml each were transferred into 50 ml Erlenmeyer flasks in order to perform a duplicate test.

Duration of test

Duration of test 1

Duration:

5 d

pH:

4

Temp.:

50 °C

Initial conc. measured:

94 other: μg/ml

Duration of test 2

Duration:

5 d

pH:

7

Temp.:

50 °C

Initial conc. measured:

145.2 other: μg/ml

Duration of test 3

Duration:

5 d

pH:

9

Temp.:

50 °C

Initial conc. measured:

101.5 other: μg/ml

Number of replicates:

2

Results and discussion

Preliminary study:

Hydrolysis reaction after 5 days incubation
pH 4 = 1 %, 2 %
pH 7 = -1 %, 0 %
pH 9 = 0 %, 0 %

Transformation products:

not measured

Dissipation DT50 of parent compound

Dissipation DT50 of parent compound 1

pH:

4

Temp.:

25 °C

DT50:

> 1 yr

Dissipation DT50 of parent compound 2

pH:

7

Temp.:

25 °C

DT50:

> 1 yr

Dissipation DT50 of parent compound 3

pH:

9

Temp.:

25 °C

DT50:

> 1 yr

Other kinetic parameters:

The results of pH 4.0, pH 7.0 and pH 9.0 showed no significant degradation of the test item at 50 °C. 
The degradation of the test item was less than 10 % after 5 days. 

Applicant's summary and conclusion

Conclusions:

hydrolytically stable

Executive summary:

The hydrolysis determination of the test material at different pH values was based on the OECD Guideline No. 111, "Hydrolysis as a Function of pH"; adopted May 12, 1981 and on the EEC Directive 92/69, Section C.7, "Abiotic Degradation: Hydrolysis as a Function of pH", L383 A, December 1992.

The results of pH 4.0, pH 7.0 and pH 9.0 showed no significant degradation of the test material at 50 °C. The degradation of the substance was less than 10 % after 5 days.

According to the EEC Directive 92/69, Section C.7 it can be concluded, that the estimated half-life time is higher than one year under representative environmental conditions (25 °C).

Therefore, the substance was considered to be hydrolytically stable, and no further testing was necessary.