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Mixture of hexa(sodium,lithium) 4-{[1,7-disulfonato-5-hydroxy-6-({4-[(6-methoxy-5-sulfonatobenzoheteromonocycle-2-yl)diazenyl]-5-alkyl-2-(3-sulfonatopropoxy)phenyl}diazenyl)naphthalen-2-yl]diazenyl}-5-hydroxy-1-(4-sulfonatophenyl)heteromonocycle-3-carboxylate and hexa(sodium,lithium) 4-{[1,7-disulfonato-5-hydroxy-6-({4-[(6-methoxy-7-sulfonatobenzoheteromonocycle-2-yl)diazenyl]-5-alkyl-2-(3-sulfonatopropoxy)phenyl}diazenyl)naphthalen-2-yl]diazenyl}-5-hydroxy-1-(4-sulfonatophenyl)heteromonocycle-3-carboxylate
EC number: - | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_environmental-fate-and-pathways.png)
Hydrolysis
Administrative data
- Endpoint:
- hydrolysis
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 11 February 2011 – 30 May 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study has been performed according to OECD and EC guidelines and in compliance with GLP principles.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 111 (Hydrolysis as a Function of pH)
- Version / remarks:
- (2004)
- Deviations:
- yes
- Remarks:
- Temperature criterion of +/- 0.5°C was not met during main test pH 9 at 20°C. For some 2.5 h an increase to max 21.9°C occurred. As this period was <1% of the duration of the pH9 main test, the temp rise was concluded to have no effect on the est.d t ½.
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.7 (Degradation: Abiotic Degradation: Hydrolysis as a Function of pH)
- Version / remarks:
- (Official Journal of the European Union no. L142, May 31, 2008)
- Deviations:
- yes
- Remarks:
- ; see OECD 111
- GLP compliance:
- yes (incl. QA statement)
Test material
- Details on test material:
- - Name of test material (as cited in study report): E-BK105
- Description: Black powder
- Batch: MB-1
- Test substance storage: At room temperature protected from light
- Stability under storage conditions: Stable
- Expiry date: 23 December 2015
Constituent 1
- Radiolabelling:
- no
Study design
- Analytical monitoring:
- yes
- Details on sampling:
- The concentration of the test substance in the test samples was determined immediately after preparation (t=0) and after 5 days (preliminary test) or 13 days at the most (main test pH 9). The samples taken at t=5 days were cooled to room temperature using running tap water. The samples were diluted in a 1:1 (v:v) ratio with 10 mM TBABr in acetonitrile and thereafter further diluted by a factor of 50 with 5 mM TBABr in 50/50 (v/v) acetonitrile/water and analysed.
Blank buffer solutions were treated similarly as the test samples and analysed at t=0.
The pH of each of the test solutions (except for the blanks) was determined at each sampling time. - Buffers:
- - pH: 4
- Type and final molarity of buffer: Acetate buffer, 0.1 M
- Composition of buffer: solution of 16.6% 0.1 M sodium acetate and 83.4% 0.1 M acetic acid. The buffer contains 0.0009% (w/v) sodium azide.
- pH: 7
- Type and final molarity of buffer: Phosphate buffer, 0.1 M
- Composition of buffer: solution of 0.1 M potassium dihydrogenphosphate adjusted to pH 7 using 10 N sodium hydroxide. The buffer contains
0.0009% (w/v) sodium azide.
- pH: 9
- Type and final molarity of buffer: Borate buffer, 0.1 M
- Composition of buffer: solution of 0.1 M boric acid and 0.1 M potassium chloride adjusted to pH 9 using 10 N sodium hydroxide. The buffer
contains 0.0009% (w/v) sodium azide. - Details on test conditions:
- Preliminary test - Tier 1:
Test substance solutions were prepared in the buffer solutions at a target concentration of 100 mg/l. Each solution was filter-sterilised through a 0.2 μm FP 30/0.2 CA-S filter (Whatman, Dassel, Germany) and transferred into a sterile vessel. To exclude oxygen, nitrogen gas was purged through the solution for 5 minutes. For each sampling time, duplicate sterile vessels under vacuum were filled with 6 ml test solution and placed in the dark in a temperature controlled environment at 49.9°C +/- 0.1°C.
Main study - Tier 2:
Test samples were prepared in the buffer solution pH 9 at a target concentration of 1000 mg/l and treated similarly as during the preliminary test. Compared to the preliminary test, E-BK105 concentration was increased by a factor 10 for detection of concentrations down to 10% of the start
concentration i.e. up to 90% hydrolysis.
The main study (pH9) was performed with the following temperatures:
temp I: 19.9°C +/- 0.5°C
temp II: 49.9°C +/- 0.2°C
temp III: 70.1°C +/- 0.2°C
The temperature during testing at 20°C was between 19.6°C and 20.4°C except for a 2.5-hours period in which the temperature increased to maximum 21.9°C. This time period was < 1% of the duration of the the main test pH 9 at 20°C. The temperature rise had no effect on the estimated half-life time and was therefore accepted. This deviation did not adversely impact the overall outcome of this study.
Duration of testopen allclose all
- Duration:
- 5 d
- pH:
- 4
- Initial conc. measured:
- 74.3 - 76.2 mg/L
- Duration:
- 5 d
- pH:
- 7
- Initial conc. measured:
- 109 - 113 mg/L
- Duration:
- 5 d
- pH:
- 9
- Initial conc. measured:
- 101 - 102 mg/L
- Duration:
- 305 h
- pH:
- 9
- Initial conc. measured:
- 1 028 - 1 043 mg/L
- Number of replicates:
- 2 measurements at each pH (separate vessels)
Results and discussion
- Preliminary study:
- At pH 4 and pH 7, a degree of hydrolysis of < 10% was observed after 5 days. It demonstrated that the half-life time of the test substance at 25°C is > 1 year. According to the guideline, no further tests were required.
At pH 9, a degree of hydrolysis of > 10% after 5 days was observed (i.e. 15%). According to the guideline, the higher Tier 2 test was required to determine the half-life time of the test substance.
A small response at the retention time of the test substance was observed in the blank buffer solutions. This was also observed in water and 5 mM TBABr in 50/50 (v/v) acetonitrile/water solutions (see also section 8, HPLC-UV: specificity). Therefore, it was considered that the response did not derive from the test substance. - Test performance:
- The mean recoveries of the buffer solutions (at time 0, preliminary test) fell within the acceptable range for non labelled chemicals of 70-110%: pH4 - 75%, pH7 - 107%, pH9 - 101%. It demonstrated that the analytical method was adequate to support the hydrolysis study on the test substance.
Total recovery of test substance (in %)open allclose all
- % Recovery:
- 74 - 76
- pH:
- 4
- Temp.:
- 49.9 °C
- % Recovery:
- 105 - 109
- pH:
- 7
- Temp.:
- 49.9 °C
- % Recovery:
- 100 - 101
- pH:
- 9
- Temp.:
- 49.9 °C
- Details on results:
- Main study (Tier 2) at 20, 50 and 70°C:
No test substance was detected in the blank buffer solutions.
The results of the Tier 2 test indicated that no significant hydrolysis (< 10%) is observed at 20 and 50°C over a period of 13 days (305 hours). At 70°C, a mean of 40% hydrolysis was observed after 13 days (305 hours).
In the main test (up to 305 hours) at 50°C, the degree of hydrolysis was observed to be < 10% which suggests that the half-life of the test substance at 25°C at pH 9 would be > 1 year. For this reason the Tier 2 test was stopped at day 13 (305 hours) and not continued for 30 days or until
90% hydrolysis was observed.
The recoveries of the test solution used in the tests at all three test temperatures fell within the criterion range of 90-110%.
Any other information on results incl. tables
Preliminary test – hydrolysis of the test substance at pH 4, pH 7 and pH 9
pH code |
Sampling time |
Analysed concentration |
Degree of hydrolysis |
Actual pH |
|
Individual |
Mean |
||||
|
|
|
|
|
|
pH 4 |
0 hours |
76.2 |
|
|
4.0 |
|
|
74.3 |
|
|
4.0 |
|
5 days |
79.8 |
-6.1 |
-3.5 |
4.0 |
|
|
75.9 |
-0.8 |
|
4.0 |
|
|
|
|
|
|
pH 7 |
0 hours |
113 |
|
|
7.1 |
|
|
109 |
|
|
7.1 |
|
5 days |
111 |
-0.2 |
0.5 |
7.1 |
|
|
110 |
1.3 |
|
7.1 |
|
|
|
|
|
|
pH 9 |
0 hours |
101 |
|
|
9.0 |
|
|
102 |
|
|
9.0 |
|
5 days |
87.1 |
14 |
15 |
9.0 |
|
|
85.6 |
16 |
|
9.0 |
|
|
|
|
|
|
Main test – hydrolysis of the test substance at 20°C
Sampling time [hours]
|
Analysed concentration [mg/] |
Relative concentration [%] |
Logarithm relative concentration
|
Actual pH
|
0 |
1028 |
99 |
2.00 |
9.0 |
0 |
1043 |
101 |
2.00 |
9.1 |
65 |
1093 |
105 |
2.02 |
9.1 |
65 |
1097 |
106 |
2.03 |
9.1 |
185 |
1037 |
100 |
2.00 |
9.0 |
185 |
1044 |
101 |
2.00 |
9.0 |
305 |
1076 |
104 |
2.02 |
9.0 |
305 |
1074 |
104 |
2.02 |
9.0 |
Main test–hydrolysis of the test substance at 50°C
Sampling time [hours]
|
Analysed concentration [mg/] |
Relative concentration [%] |
Logarithm relative concentration
|
Actual pH
|
0 |
1028 |
99 |
2.00 |
9.0 |
0 |
1043 |
101 |
2.00 |
9.1 |
65 |
1034 |
100 |
2.00 |
9.1 |
65 |
1033 |
100 |
2.00 |
9.1 |
185 |
964 |
93 |
1.97 |
9.0 |
185 |
962 |
93 |
1.97 |
9.0 |
305 |
971 |
94 |
1.97 |
9.0 |
305 |
959 |
93 |
1.97 |
9.0 |
Main test–hydrolysis of the test substance at 70°C
Sampling time [hours]
|
Analysed concentration [mg/] |
Relative concentration [%] |
Logarithm relative concentration
|
Actual pH
|
0 |
1028 |
99 |
2.00 |
9.0 |
0 |
1043 |
101 |
2.00 |
9.1 |
17 |
942 |
91 |
1.96 |
9.1 |
17 |
883 |
85 |
1.93 |
9.1 |
25 |
891 |
86 |
1.93 |
9.1 |
25 |
879 |
85 |
1.93 |
9.1 |
41 |
869 |
84 |
1.92 |
9.1 |
41 |
974 |
84 |
1.93 |
9.1 |
65 |
1093 |
83 |
1.92 |
9.1 |
65 |
1097 |
82 |
1.92 |
9.1 |
185 |
1037 |
68 |
1.83 |
9.0 |
185 |
1044 |
67 |
1.82 |
9.0 |
305 |
1076 |
51 |
1.71 |
9.0 |
305 |
1074 |
69 |
1.84 |
9.0 |
Applicant's summary and conclusion
- Conclusions:
- Based on all experiments performed for the determination of the rate of hydrolysis of E-BK105 at pH values normally found in the environment (pH 4-9), it was concluded that the half-life times of E-BK105 at 25°C are > 1 year at pH4, pH7 and pH9.
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