Registration Dossier
Registration Dossier
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EC number: 229-158-0 | CAS number: 6420-33-3
Hydrolysis
Administrative data
- Endpoint:
- hydrolysis
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 24 November 2016 to 25 April 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 111 (Hydrolysis as a Function of pH)
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.7 (Degradation: Abiotic Degradation: Hydrolysis as a Function of pH)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Tetrasodium 3,3'-[carbonylbis[imino(5-methoxy-2-methyl-4,1-phenylene)azo]]bis(naphthalene-1,5-disulphonate)
- EC Number:
- 229-158-0
- EC Name:
- Tetrasodium 3,3'-[carbonylbis[imino(5-methoxy-2-methyl-4,1-phenylene)azo]]bis(naphthalene-1,5-disulphonate)
- Cas Number:
- 6420-33-3
- Molecular formula:
- C37H28N6Na4O15S4
- IUPAC Name:
- tetrasodium 3-({4-[({4-[(4,8-disulfonato-2-naphthyl)diazenyl]-2-methoxy-5-methylphenyl}carbamoyl)amino]-5-methoxy-2-methylphenyl}diazenyl)naphthalene-1,5-disulfonate
- Test material form:
- solid: flakes
- Details on test material:
- dentification: C.I. Direct Yellow 133
Physical state/Appearance: Brown/orange solid flakes
Expiry Date: 01 September 2021
Storage Conditions: Room temperature in the dark
Constituent 1
- Radiolabelling:
- no
Study design
- Analytical monitoring:
- yes
- Details on sampling:
- - Sampling time for parent: at 0, 24 and 120 hours in duplicate
- Sample storage conditions before analysis: no data
Duplicate aliquots (A and B) of each sample solution were diluted by a factor of 50 using acetonitrile: relevant buffer (1:9 v/v). - Buffers:
- -pH 4
Citric acid 0.006 mol/dm3
Sodium chloride 0.004 mol/dm3
Sodium hydroxide 0.007 mol/dm3
pH 7
Disodium hydrogen orthophosphate (anhydrous) 0.003 mol/dm3
Potassium dihydrogen orthophosphate 0.002 mol/dm3
Sodium chloride 0.002 mol/dm3
pH 9
Disodium tetraborate 0.001 mol/dm3
Sodium chloride 0.002 mol/dm3 - Details on test conditions:
- Pre-test
- Measures taken to avoid photolytic effects: shielded from light
- Measures to exclude oxygen: ultrasonication and degassing with nitrogen
- Nominal concentration: 2.0 g/L
- Temperature: 50.0 ± 0.5 °C
Duration of testopen allclose all
- Duration:
- 120 h
- pH:
- 4
- Temp.:
- 50 °C
- Initial conc. measured:
- >= 1.97 - <= 1.98 g/L
- Duration:
- 120 h
- pH:
- 7
- Temp.:
- 50 °C
- Initial conc. measured:
- 2.03 g/L
- Duration:
- 120 h
- pH:
- 9
- Temp.:
- 50 °C
- Initial conc. measured:
- 2.04 g/L
- Number of replicates:
- 2/pH
- Positive controls:
- no
- Negative controls:
- no
- Statistical methods:
- NA
Results and discussion
- Preliminary study:
- only a pre-liminary study was performed
- Transformation products:
- not measured
Dissipation DT50 of parent compoundopen allclose all
- Key result
- pH:
- 4
- Temp.:
- 50 °C
- Remarks on result:
- hydrolytically stable based on preliminary test
- Key result
- pH:
- 7
- Temp.:
- 50 °C
- Remarks on result:
- hydrolytically stable based on preliminary test
- Key result
- pH:
- 9
- Temp.:
- 50 °C
- Remarks on result:
- hydrolytically stable based on preliminary test
Any other information on results incl. tables
pH 4
Time (Hours)
|
Concentration (g/L)
|
% of mean initial concentration |
||
|
A |
B |
A |
B |
0 |
1.97 |
1.98 |
- |
- |
24 |
1.95 |
2.01 |
98.6 |
102 |
120 |
2.41 |
2.37 |
122 |
120 |
pH 7
Time (Hours)
|
Concentration (g/L)
|
% of mean initial concentration |
||
|
A |
B |
A |
B |
0 |
2.03 |
2.03 |
- |
- |
24 |
1.96 |
1.98 |
96.2 |
97.2 |
120 |
2.33 |
2.32 |
115 |
118 |
pH 9
Time (Hours)
|
Concentration (g/L)
|
% of mean initial concentration |
||
|
A |
B |
A |
B |
0 |
2.04 |
2.04 |
- |
- |
24 |
1.92 |
2.04 |
94.4 |
100 |
120 |
2.37 |
2.40 |
116 |
117 |
Applicant's summary and conclusion
- Validity criteria fulfilled:
- not applicable
- Conclusions:
- The substance is stable for > 1 year at pH 4, 7 and 9 at 25 °C
- Executive summary:
In a preliminary hydrolysis study the substance was incubated at pH 4, 7 and 9 at 50 °C during 120 hours. The hydrolysis was less than 10% after 5 days at 50 °C, equivalent to a half-life greater
than 1 year at 25 °C
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