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EC number: 227-497-9 | CAS number: 5858-81-1
Hydrolysis
Administrative data
- Endpoint:
- hydrolysis
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 21 March 2017 - 19 October 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Cross-reference
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.7 (Degradation: Abiotic Degradation: Hydrolysis as a Function of pH)
- Version / remarks:
- 2008
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 111 (Hydrolysis as a Function of pH)
- Version / remarks:
- 2004
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 835.2120 (Hydrolysis of Parent and Degradates as a Function of pH at 25°C)
- Version / remarks:
- 2008
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Disodium 3-hydroxy-4-[(4-methyl-2-sulphonatophenyl)azo]-2-naphthoate
- EC Number:
- 227-497-9
- EC Name:
- Disodium 3-hydroxy-4-[(4-methyl-2-sulphonatophenyl)azo]-2-naphthoate
- Cas Number:
- 5858-81-1
- Molecular formula:
- C18H12N2Na2O6S
- IUPAC Name:
- disodium 3-hydroxy-4-[(4-methyl-2-sulphonatophenyl)azo]-2-naphthoate
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Appearance: Red powder
- Storage conditions: At room temperature
Constituent 1
Study design
- Analytical monitoring:
- yes
- Details on sampling:
- PREPARATION OF THE SAMPLES
- The test item was spiked to the buffers using a solution of the test item in water (500 mg/L)
- Target concentration: 1.5 mg/L.
- For each sampling time, duplicate vessels under vacuum were filled with 6 mL test solution.
- The vessels were placed in a temperature controlled environment in the dark.
- Blank buffers containing a similar content of blank spiking solution were treated similarly as the test samples (at t=0).
SAMPLING DETAILS
- Samples for analysis were taken immediately after preparation (t=0) and at t= 5 days.
- Samples take at t= 5 days were cooled to room temperature using running tap water.
pH MEASUREMENTS
The pH of the test solutions (except for the blanks) was determined at each sampling point. - Buffers:
- Buffer pH 4: 16.7% 0.1M sodium acetate and 83.3% 0.1M acetic acid in water.
Buffer pH 7: 0.1M potassium di-hydrogenphosphate in water adjusted to pH 7 using 10N sodium hydroxide.
Buffer pH 9: 0.1M boric acid and 0.1M potassium chloride in water adjusted to pH 9 using 10N sodium hydroxide.
Details:
- Kind of water: tap water purified by a purification system (Milli-Q, Millipore)
- Sodium azide content: 0.0009% (w/v) - Details on test conditions:
- TEST SYSTEM
- Sterilisation method: Each buffer was filter-sterilised through a 0.2 µm FP 30/0.2 CA-S filter (Whatman) and transferred into a sterile vessel.
- Measures to exclude oxygen: nitrogen gas was purged through the sterile buffers for 5 minutes prior to preparation of the blank and test solutions.
- Measures taken to avoid photolytic effects: the test vessels were kept in the dark.
TEST MEDIUM
- Identity and concentration of co-solvent: The spiking volume was < 1% of the sample volume. Nominal concentrations were not corrected for the spiking volume.
DETAILS TIER 1
pH 4.0, pH 7.0 and pH 9.0 at 49.4 ± 0.9°C
Duration of testopen allclose all
- Duration:
- 5 d
- pH:
- 4
- Temp.:
- 50 °C
- Initial conc. measured:
- ca. 1.8 mg/L
- Remarks:
- See Table 1
- Duration:
- 5 d
- pH:
- 7
- Temp.:
- 50 °C
- Initial conc. measured:
- ca. 1.7 mg/L
- Remarks:
- See Table 1
- Duration:
- 5 d
- pH:
- 9
- Temp.:
- 50 °C
- Initial conc. measured:
- ca. 1.8 mg/L
- Remarks:
- See Table 1
- Number of replicates:
- Two
- Positive controls:
- no
- Negative controls:
- no
Results and discussion
- Preliminary study:
- At pH 4, 7 and pH 9, a degree of hydrolysis < 10% was observed after 5 days at 50°C (half-life time at 25°C is > 1 year). No further tests were required.
- Test performance:
- RECOVERIES
- Recovery is the concentration analysed at t=0 relative to the nominal concentration.
- The mean (n=2) recovery at each pH was calculated (see table below).
- The mean recoveries fell within the criterion range of 90-110%.
- Concentrations analysed in the test samples were not corrected for recovery. - Transformation products:
- no
- Details on hydrolysis and appearance of transformation product(s):
- not applicable
Total recovery of test substance (in %)open allclose all
- % Recovery:
- 102
- pH:
- 4
- Temp.:
- 50 °C
- Remarks on result:
- other: Tier 1
- % Recovery:
- 98
- pH:
- 7
- Temp.:
- 50 °C
- Remarks on result:
- other: Tier 1
- % Recovery:
- 101
- pH:
- 9
- Temp.:
- 50 °C
- Remarks on result:
- other: Tier 1
Dissipation DT50 of parent compoundopen allclose all
- Key result
- pH:
- 4
- Temp.:
- 25 °C
- DT50:
- > 1 yr
- Remarks on result:
- hydrolytically stable based on preliminary test
- Key result
- pH:
- 7
- Temp.:
- 25 °C
- DT50:
- > 1 yr
- Remarks on result:
- hydrolytically stable based on preliminary test
- Key result
- pH:
- 9
- Temp.:
- 25 °C
- DT50:
- > 1 yr
- Remarks on result:
- hydrolytically stable based on preliminary test
Any other information on results incl. tables
Table: Preliminary Test: Hydrolysis of the Test Item at pH 4, pH 7 and pH 9
pH code | Sampling time | Analyzed concentration [mg/L] | Degree of hydrolysis [%] | pH | |
Individual | Mean | ||||
pH 4 | 0 hours | 1.77 |
|
| 4.0 |
|
| 1.78 |
|
| 4.0 |
| 5 days | 1.84 | -3.4 | -3.4 | 4.0 |
|
| 1.84 | -3.3 |
| 4.0 |
pH 7 | 0 hours | 1.72 |
|
| 7.0 |
|
| 1.72 |
|
| 7.0 |
| 5 days | 1.80 | -4.4 | -4.0 | 7.0 |
|
| 1.78 | -3.6 |
| 7.0 |
pH 9 | 0 hours | 1.77 |
|
| 9.0 |
|
| 1.76 |
|
| 9.0 |
| 5 days | 1.82 | -3.1 | -3.0 | 9.0 |
|
| 1.82 | -2.8 |
| 9.0 |
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- The substance is hydrolytically stable at pH 4, 7 and 9 (half-life time at 25°C : > 1 year).
- Executive summary:
The hydrolysis study at pH values normally found in the environment (pH 4, 7 and 9) was performed in a GLP-compliant study according to EC C.7, OECD 111 and EPA OPPTS 835.2120. A degree of < 10% of hydrolysis was observed at pH 4, 7 and 9 after 5 days at 50°C (Tier 1). This corresponds with a half-life time at 25°C of > 1 year. The substance is concluded to be hydrolytically stable at pH 4, 7 and 9.
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