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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
Link to relevant study record(s)
- Endpoint:
- hydrolysis
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2015-09-30
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- The main structure of the read-across substance is the same of the CJ304, only the salt form is different. However, this difference does not influence the toxicity of the CJ304. CJ304 contains Li/Na salt form and the read-across substances contains only Na salt. This will not lead to difference on the toxicity results.
- 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)
- Specific details on test material used for the study:
- Identification: FAT 41001/H TE
Physical State/Appearance: Dark blue Solid
Commercial Name: Reactive Blue 049
EC No: 276-481-8
CAS No: 72214-18-7
Batch: BOP 01-12 (Lot: BS-1106872)
Purity: 77.3 %
Expiry: 31 January 2017
Storage Conditions: Frozen in the dark - Radiolabelling:
- no
- Analytical monitoring:
- yes
- Remarks:
- The concentration of the sample solution was determined by high performance liquid chromatography (HPLC).
- Details on sampling:
- Duplicate aliquots (A and B) of each sample solution were diluted by a factor of 10 using dimethyl sulfoxide (DMSO).
- Buffers:
- - Buffer solution pH 4 : Citric acid 0.006 mol dmE-3, Sodium chloride 0.004 mol dmE-3, Sodium hydroxide 0.007 mol dmE-3.
- Buffer solution pH 7 : Disodium hydrogen orthophosphate (anhydrous) 0.003 mol dmE-3, Potassium dihydrogen orthophosphate 0.002 mol dmE-3, Sodium chloride 0.002mol dmE-3.
- Buffer solution pH 9 : Disodium tetraborate 0.001 mol dmE-3, Sodium chloride 0.002 mol dmE-3. - Details on test conditions:
Performance of the Test
Preparation of the Test Solutions
Sample solutions were prepared in stoppered glass flasks at a nominal concentration of 5 g/L in the three buffer solutions.
The concentration of each solution did not exceed the lesser of 0.01 mol/L or half the water solubility.
The test solutions were split into individual vessels for each data point.
The solutions were shielded from light whilst maintained at the test temperature.
Preliminary Test
Sample solutions were prepared at a nominal concentration of 5 g/L at pH 4, 7 and 9 and maintained at 50.0 ± 0.5 °C for a period of 120 hours.
Tier 2
Results from the Preliminary test showed it was necessary to undertake further testing at pH 4, with solutions being maintained at 50.0 ± 0.5 °C, 60.0 ± 0.5 °C and 70.0 ± 0.5 °C for a period of 720, 408 and 360 hours respectively.- Duration:
- 120 h
- pH:
- 4
- Temp.:
- 50 °C
- Initial conc. measured:
- 5 g/L
- Duration:
- 120 h
- pH:
- 7
- Temp.:
- 50 °C
- Initial conc. measured:
- 5 g/L
- Duration:
- 120 h
- pH:
- 9
- Temp.:
- 50 °C
- Initial conc. measured:
- 5 g/L
- Duration:
- 720 h
- pH:
- 4
- Temp.:
- 50 °C
- Initial conc. measured:
- 5 g/L
- Duration:
- 408 h
- pH:
- 4
- Temp.:
- 60 °C
- Initial conc. measured:
- 5 g/L
- Duration:
- 360 h
- pH:
- 4
- Temp.:
- 70 °C
- Initial conc. measured:
- 5 g/L
- Number of replicates:
- two
- Positive controls:
- no
- Negative controls:
- no
- Preliminary study:
- The extent of hydrolysis after 120 hours indicated that further tests (Tier 2), conducted at 40 ± 0.5 °C, 50 ± 0.5 °C and 60 ± 0.5 °C, were required to estimate the rate constant and half-life at 25 °C.
Preliminary pH 7 Test at 50.0 ± 0.5 ºC
Less than 10% hydrolysis after 5 days at 50.0 ± 0.5 °C, equivalent to a half-life greater than 1 year at 25 °C.
Preliminary pH 9 Test at 50.0 ± 0.5 ºC
Less than 10% hydrolysis after 5 days at 50.0 ± 0.5 °C, equivalent to a half-life greater than 1 year at 25 °C. - Test performance:
- No data
- Transformation products:
- not measured
- pH:
- 4
- Temp.:
- 25 °C
- Hydrolysis rate constant:
- > 0 - < 0 s-1
- DT50:
- > 110 - < 126 d
- Type:
- (pseudo-)first order (= half-life)
- pH:
- 7
- Temp.:
- 25 °C
- DT50:
- > 1 yr
- pH:
- 9
- Temp.:
- 25 °C
- DT50:
- > 1 yr
- Details on results:
- pH 4 Test at 50.0 ± 0.5 ºC - Tier 2– Peak 1
Slope = -6.49E-04
kobs = 1.49E-03 hour-1
= 4.15E-07 second-1
t½ = 464 hours
= 19.3 days
pH 4 Test at 50.0 ± 0.5 ºC - Tier 2– Peak 2
Slope = -7.02E-04
kobs = 1.62E-03 hour-1
= 4.49E-07 second-1
t½ = 429 hours
= 17.9 days
pH 4 Test at 60.0 ± 0.5 ºC - Tier 2– Peak 1
Slope = -1.30E-03
kobs = 3.00E-03 hour-1
= 8.34E-07 second-1
t½ = 231 hours
= 9.62 days
pH 4 Test at 60.0 ± 0.5 ºC - Tier 2– Peak 2
Slope = -1.36E-03
kobs = 3.13E-03 hour-1
= 8.69E-07 second-1
t½ = 222 hours
= 9.23 days
pH 4 Test at 70.0 ± 0.5 ºC - Tier 2– Peak 1
Slope = -2.40E-03
kobs = 5.23E-03 hour-1
= 1.5E-06 second-1
t½ = 125 hours
= 5.22 days
pH 4 Test at 70.0 ± 0.5 ºC - Tier 2– Peak 2
Slope =-2.48E-03
kobs = 5.72E-03 hour-1
= 1.59E-06 second-1
t½ = 121 hours
= 5.05 days
pH 4 Arrhenius Data – Peak 1
From the graph of the data, the rate constant and half-life at 25 °C have been estimated to be as follows:
kobs = 2.29E-04 hour-1
= 6.36E-08 second-1
t½ = 3.03E+03 hours
= 126 days
pH 4 Arrhenius Data – Peak 2
From the graph of the data, the rate constant and half-life at 25 °C have been estimated to be as follows:
kobs = 2.63E-04 hour-1
= 7.31E-08 second-1
t½ = 2.63E+03 hours
= 110 days - Validity criteria fulfilled:
- yes
- Conclusions:
- The rate constant and estimated half-life at 25 °C of the test item are:
At pH 4 the rate constant (peak 1) was 6.36E-08 s-1 at 25 °C
At pH 4 the rate constant (peak 2) was 7.31E-08 s-1 at 25 °C
The estimated half life at pH 4 at 25 °C (peak 1) was 126 days.
The estimated half life at pH 4 at 25 °C (peak 2) was 110 days.
The estimated half life at pH 7 at 25 °C was > 1 year.
The estimated half life at pH 9 at 25 °C was > 1 year. - Executive summary:
Assessment of hydrolytic stability was carried out using a procedure designed to be compatible with Method C7 Abiotic Degradation, Hydrolysis as a Function of pH of Commission Regulation (EC) No 440/2008 of 30 May 2008 and Method 111 of the OECD Guidelines for Testing of Chemicals, 13 April 2004.
The test substance was evaluated at pH 4 for 120 h, 360 h, 480 h and 720 h. For pH 7 and 9 the duration was 120 h. All tests were carried out at 50 °C. The concentration used was 5 g/L.
Based on the findings of the study,
The rate constant and estimated half-life at 25 °C of the test item are:
At pH 4 the rate constant (peak 1) was 6.36 x 10-8 s-1 at 25 °C
At pH 4 the rate constant (peak 2) was 7.31 x 10-8 s-1 at 25 °C
The estimated half life at pH 4 at 25 °C (peak 1) was 126 days.
The estimated half life at pH 4 at 25 °C (peak 2) was 110 days.
The estimated half life at pH 7 at 25 °C was >1 year.
The estimated half life at pH 9 at 25 °C was >1 year.
Reference
Description of key information
A study was performed to measure the abiotic degradation of the test article according to OECD guideline 111 at 50 °C ± 0.1 °C at each of pH 4.0, pH 7.0, and pH 9.0.
The results of pH 7.0 and pH 9.0 showed no significant degradation of FAT 41'001/H. In conclusion, FAT 41001/H was considered to be hydrolytically stable at pH 7.0 and pH 9.0.
The results at pH 4.0 showed that FAT 41001/H is not stable at this pH range. Therefore, according to the guidelines advanced testing of FAT 41001/H was performed to determine the rate constant (K25) of the FAT 41001/H hydrolysis reaction at pH 4.0. As a result of all observations, it can be stated that the hydrolysis reaction of FAT 41001/H at pH 4.0 and 25 °C was estimated to be relative slow (t1/2 (25 °C) about 110 days)
Key value for chemical safety assessment
- Half-life for hydrolysis:
- 110 d
- at the temperature of:
- 25 °C
Additional information
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.
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