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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
EC number: 235-628-6 | CAS number: 12392-64-2
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 2012-08-22 to 2012-08-27
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study with GLP statement performed on a similar substance
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 111 (Hydrolysis as a Function of pH)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Trisodium bis[3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]-7-nitronaphthalene-1-sulphonato(3-)]chromate(3-)
- EC Number:
- 260-906-9
- EC Name:
- Trisodium bis[3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]-7-nitronaphthalene-1-sulphonato(3-)]chromate(3-)
- Cas Number:
- 57693-14-8
- Molecular formula:
- C40H20CrN6O14S2.3Na
- Test material form:
- other: solid and liquid preparations
Constituent 1
- Radiolabelling:
- no
Study design
- Analytical monitoring:
- yes
- Details on sampling:
- - Sampling intervals for the parent/transformation products: Samples were taken at 0 h and after 120 h. All samples were analysed directly. All test item containing samples were analysed immediately (max. 30 minutes until start of analyses) via HPLC with UV (DAD) detection.- Sample storage conditions before analysis: Direct analyses
- Buffers:
- Buffer solution pH 445 mL of 0.1 mol/L NaOH were mixed with 250 mL 0.1 mol/L KH2-Citrate and diluted to 500 mL with double distilled water.Buffer solution pH 7148.15 mL of 0.1 mol/L NaOH were mixed with 250 mL 0.1 mol/L KH2PO4, diluted to 500 mL with double distilled water.Buffer solution pH 9106.5 mL of 0.1 mol/L NaOH were mixed with 250 mL 0.1 mol/L H3BO3 in 0.1 mol/L KCL, diluted to 500 mL with double distilled water.Buffers were prepared on 2012-08-01, purged with nitrogen for 5 minutes and the pH was checked. Afterwards the buffer solutions were sterilised by filtration through 0.2 µm.
- Details on test conditions:
- TEST SYSTEM- Type, material and volume of test flasks, other equipment used: Amber HPLC vials, 4 mL- Measures taken to avoid photolytic effects: Photolytic effects were avoided by exclusion of direct light- Measures to exclude oxygen: Buffers were purged with nitrogen for 5 minutes and the pH was checked. Afterwards the buffer solutions were sterilised by filtration through 0.2 µm.- Is there any indication of the test material adsorbing to the walls of the test apparatus? NoTEST MEDIUM- Volume used/treatment: 4 mL - Preparation of test medium: 3.6 mL of the respective sterile buffer were spiked to 10 mg/L with the test item stock solution into the test containers, sealed and transferred into the thermostat. The time between test item application and transfer to laboratory incubator/analysis did not exceed 30 minutes.- Renewal of test solution: None
Duration of testopen allclose all
- Duration:
- 120 h
- pH:
- 4
- Temp.:
- 50 °C
- Initial conc. measured:
- 9.3 mg/L
- Duration:
- 120 h
- pH:
- 7
- Temp.:
- 50 °C
- Initial conc. measured:
- 9.14 mg/L
- Duration:
- 120 h
- pH:
- 9
- Temp.:
- 50 °C
- Initial conc. measured:
- 9.11 mg/L
- Number of replicates:
- Two replicate at each sampling interval
- Positive controls:
- no
- Negative controls:
- yes
- Remarks:
- buffer solutions (pH 4, 7 and 9)
Results and discussion
- Preliminary study:
- The analogue substance was found to be stable in the preliminary test at pH 4, 7 and 9 at 50 °C. Reaction rate constants and half lives could not be calculated due to the fact that the test item undergoes no significant hydrolysis. According to the guideline a half life of > 1 year under environmental conditions can be assumed.
- Transformation products:
- no
Dissipation DT50 of parent compound
- Remarks on result:
- hydrolytically stable based on preliminary test
- Details on results:
- TEST CONDITIONS- pH, sterility, temperature, and other experimental conditions maintained throughout the study: Yes
Any other information on results incl. tables
Hydrolysis Results for analogue substance at pH 4 and 50 °C
Hydrolysis Time [hours] |
Replicate |
Concentration [mg/L] |
Mean |
Degradation [%] |
0 |
1 |
10.2 |
10.1 |
- |
2 |
10.0 |
|||
120 |
1 |
9.22 |
9.30 |
7.92 |
2 |
9.38 |
Hydrolysis Results for analogue substance at pH 7 and 50 °C
Hydrolysis Time [hours] |
Replicate |
Concentration [mg/L] |
Mean |
Degradation [%] |
0 |
1 |
10.0 |
10.0 |
- |
2 |
10.0 |
|||
120 |
1 |
9.09 |
9.14 |
8.60 |
2 |
9.18 |
Hydrolysis Results for analogue substance at pH 9 and 50 °C
Hydrolysis Time [hours] |
Replicate |
Concentration [mg/L] |
Mean |
Degradation [%] |
0 |
1 |
10.1 |
10.1 |
- |
2 |
10.0 |
|||
120 |
1 |
9.00 |
9.11 |
9.80 |
2 |
9.21 |
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- The analogue substance was found to be stable in the preliminary test at pH 4, 7 and 9 at 50 °C. Reaction rate constants and half lives could not be calculated due to the fact that the test item undergoes no significant hydrolysis. According to the guideline a half life of > 1 year under environmental conditions can be assumed.
- Executive summary:
Hydrolysis as a function of pH was determined according to OECD Guideline No. 111 and Council Regulation (EC) No. 440/2008, Method C.7 for the analogue substance from 2012-08-22 to 2012-08-27 at Dr.U.Noack-Laboratorien, 31157 Sarstedt, Germany.
The study was conducted with test item concentrations of 10 mg/L in buffer solutions at pH 4, 7 and 9 at a test temperature of 50 °C (preliminary test).
Samples were taken at test start (0 hours) and test end (120 hours) and analysed via HPLC with UV (DAD) detection on a cyano-propyl column using an external standard. Buffer solutions were analysed at test start and test end and indicated no interference with the test item. The analytical method for determination of the test item was validated and tested with satisfactory results in regard to linearity, accuracy, precision and specificity.
Degradation was calculated as the percentage loss of the test item over the time. In the preliminary test, the test item was found to be stable at pH 4, 7 and 9, respectively. No further testing was deemed necessary as less than 10 % of the applied test item was transformed after 120 hours (5 days) at a temperature of 50 °C and each of the three pH values (Table 1). Reaction rate constants and half lives could not be calculated because the test item undergoes no significant hydrolysis. With respect to the guidelines a half life of > 1 year could be assumed for environmental typical temperature conditions.
Degradation [%] at 50 °C after 120 Hours
Hydrolysis Time
[hours]
Degradation [%]
pH 4
pH 7
pH 9
120
7.92
8.60
9.80
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.