Disodium {sulfonylbis[4,1-phenylenediazene-2,1-diyl(1-ethyl-6-hydroxy-4-methyl-2-oxo-1,2-dihydropyridine-5,3-diyl)]}dimethanesulfonate

Hydrolysis

Administrative data

Endpoint:

hydrolysis

Type of information:

experimental study

Adequacy of study:

key study

Study period:

13-Oct-2010 to 08-Mar-2011

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The study report was conclusive, done to a valid guideline and the study was conducted under GLP conditions.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2011

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 111 (Hydrolysis as a Function of pH)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Acid Yellow RN 2903

IUPAC Name:

Acid Yellow RN 2903

Details on test material:

Identification: Acid Yellow RN 2903
Batch Number: Vers. Kilo 6, 26.05.2009
Purity: 65.7 %
Expiry Date: August 01, 2015
Storage Conditions: At room temperature at about 20 °C

Radiolabelling:

no

Study design

Analytical monitoring:

yes

Estimation method (if used):

Not used.

Duration of test

Duration of test 1

Duration:

120 h

pH:

4

Temp.:

50 °C

Initial conc. measured:

442 508 other: peak area counts

Duration of test 2

Duration:

120 h

pH:

4

Temp.:

50 °C

Initial conc. measured:

460 905 other: peak area counts

Duration of test 3

Duration:

120 h

pH:

7

Temp.:

50 °C

Initial conc. measured:

448 418 other: peak area counts

Duration of test 4

Duration:

120 h

pH:

7

Temp.:

50 °C

Initial conc. measured:

450 415 other: peak area counts

Duration of test 5

Duration:

120 h

pH:

9

Temp.:

50 °C

Initial conc. measured:

462 890 other: peak area counts

Duration of test 6

Duration:

120 h

pH:

9

Temp.:

50 °C

Initial conc. measured:

467 983 other: peak area counts

Number of replicates:

Duplicate aliquots (A and B) of sample solution were measured.

Positive controls:

not specified

Negative controls:

not specified

Statistical methods:

Not specified.

Results and discussion

Transformation products:

not specified

Total recovery of test substance (in %)

Total recovery of test substance (in %) 1

% Recovery:

98

pH:

4

Temp.:

50 °C

Duration:

120 h

Total recovery of test substance (in %) 2

% Recovery:

96

pH:

4

Temp.:

50 °C

Duration:

120 h

Total recovery of test substance (in %) 3

% Recovery:

100

pH:

7

Temp.:

50 °C

Duration:

120 h

Total recovery of test substance (in %) 4

% Recovery:

101

pH:

7

Temp.:

50 °C

Duration:

120 h

Total recovery of test substance (in %) 5

% Recovery:

101

pH:

9

Temp.:

50 °C

Duration:

120 h

Total recovery of test substance (in %) 6

% Recovery:

102

pH:

9

Temp.:

50 °C

Duration:

120 h

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:

None.

Details on results:

At pH4, 7 and 9 there was less than 10% hydrolysis after 5 days at 50°C, equivalent to a half-life greater than 1 year at 25°C.

Any other information on results incl. tables

The results of the individual measurements are summarized in the attached table. The tabulated values represent rounded results obtained by calculation used the exact raw data.

 

A typical chromatogram of a standard solution is given in the attached Figure 1. Typical chromatograms of the test solutions after an incubation time of 5 days are given in the attached Figure 2 to Figure 4. The calibration curve of Acid Yellow RN 2903 is shown in the attached Figure 5. The calibration data are given in the attached Table 2. The r² fit was 0.9990 (optimum 1.0000). This reflects the suitability of the HPLC-system within the range of 0.4758 µg/mL to 23.79 µg/mL of test item.

 

The results of the tests at pH 4.0, pH 7.0 and pH 9.0 showed no significant degradation of Acid Yellow RN 2903 at 50 °C.

 

  Table 1       Results of the Preliminary Test of Acid Yellow RN 2903

	pH 4		pH 7		pH 9
	P1	P2	P3	P4	P5	P6
InitialPeak Areameasured	442508	460905	448418	450415	462890	467983
Peak Area measured after 2.40 hours incubation	451426	446639	444230	464684	459652	466317
Peak Areameasured after 120.0 hours incubation	435365	442071	448506	454383	466285	476743
Hydrolysis after 120.0 hours [%]	2	4	0	-1	-1	-2

 

 

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

The degradation of Acid Yellow RN 2903 was less than 10% after 5 days at 50 °C and pH 4, 7 and 9. Acid Yellow RN 2903 was considered to be hydrolytically stable, and no further testing was necessary.

Executive summary:

The hydrolysis determination of Acid Yellow RN 2903 at different pH values was based on the OECD Guideline No. 111, “Hydrolysis as a Function of pH”; adoptedApril 13, 2004.

 

The results of the tests at pH 4.0, pH 7.0 and pH 9.0 showed no significant degradation of Acid Yellow RN 2903 at 50 °C. The degradation of Acid Yellow RN 2903 was less than 10% after 5 days. These results are summarized in the table below.

 

pH	Hydrolysis after 5 days, 50 °C [%]
4.0	< 10
7.0	< 10
9.0	< 10

 

 

According to theEECDirective 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, Acid Yellow RN 2903 is considered to be hydrolytically stable, and no further testing was necessary.