Registration Dossier

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 guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 111 (Hydrolysis as a Function of pH)
Deviations:
no
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

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 testopen allclose all
Duration:
120 h
pH:
4
Temp.:
50 °C
Initial conc. measured:
442 508 other: peak area counts
Duration:
120 h
pH:
4
Temp.:
50 °C
Initial conc. measured:
460 905 other: peak area counts
Duration:
120 h
pH:
7
Temp.:
50 °C
Initial conc. measured:
448 418 other: peak area counts
Duration:
120 h
pH:
7
Temp.:
50 °C
Initial conc. measured:
450 415 other: peak area counts
Duration:
120 h
pH:
9
Temp.:
50 °C
Initial conc. measured:
462 890 other: peak area counts
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 %)open allclose all
% Recovery:
98
pH:
4
Temp.:
50 °C
Duration:
120 h
% Recovery:
96
pH:
4
Temp.:
50 °C
Duration:
120 h
% Recovery:
100
pH:
7
Temp.:
50 °C
Duration:
120 h
% Recovery:
101
pH:
7
Temp.:
50 °C
Duration:
120 h
% Recovery:
101
pH:
9
Temp.:
50 °C
Duration:
120 h
% Recovery:
102
pH:
9
Temp.:
50 °C
Duration:
120 h
Dissipation DT50 of parent compoundopen allclose all
pH:
4
Temp.:
25 °C
DT50:
> 1 yr
pH:
7
Temp.:
25 °C
DT50:
> 1 yr
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.