Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
Welcome to the ECHA website. This site is not fully supported in Internet Explorer 7 (and earlier versions). Please upgrade your Internet Explorer to a newer version.
This website uses cookies to ensure you get the best experience on our websites.
Find out more on how we use cookies.