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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 268-608-0 | CAS number: 68131-04-4
- 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
Sediment toxicity
Administrative data
- Endpoint:
- sediment toxicity: long-term
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
- Justification for type of information:
- JUSTIFICATION FOR DATA WAIVING
In accordance with Column 2 Annex X REACH, the long-term toxicity testing does not need to be carried out as the results of the chemical safety assessment indicates the need to investigate further the effects of the substance and/or relevant degradation products on sediment organisms. According to results of hydrolysis study, the half time of degradation is estimated to be more than 1 year. Therefore, no degradation product of parental substance are expected in sediment. This resume is supported by triggering criteria in Guidance on information requirements and chemical safety assessment, Chapter R.7b, part R.7.8.10.3 c), point iii. Information on degradation of the parent compound in the water column showing formation of relevant metabolites (see Section R.7.1) that will be distributed to the sediment and point iv. Information on degradation of the parent compound in the sediment showing formation of metabolites exclusively in this compartment (i.e. indications of anaerobic/aerobic degradation in the sediment to relevant metabolites). Neither one of points is fulfiled for the substance.
Cross-reference
- Reason / purpose for cross-reference:
- data waiving: supporting information
Reference
- Endpoint:
- hydrolysis
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from January 23, 2007 to March 5. 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.7 (Degradation: Abiotic Degradation: Hydrolysis as a Function of pH)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Radiolabelling:
- no
- Analytical monitoring:
- yes
- Details on sampling:
- - Sampling intervals for the parent/transformation products: 0, cca 1 day, cca 2 days, cca 4 days, cca 5 days
- Sampling method: sampling from volumetric flask by pipette and diluting with water to required concentration.
- Sampling intervals/times for pH measurements:
- Sampling intervals/times for sterility check:
- Sample storage conditions before analysis: The samples were analyzed in a short time after sampling.
- Other observation: no
- Temperature control: The actual temperature of the thermostatic bath was controlled during the whole test every when the sampling was done. - Buffers:
- - pH: 4,7,9
- Type and final molarity of buffer: Buffer mixtures – Clark and Lubs
- Composition of buffer:
pH 4: phthalate buffer
pH 7: fosphate buffer
pH 9: borate buffer - Details on test conditions:
- TEST SYSTEM
- Type, material and volume of test flasks, other equipment used: volumetric flask 250 mL
- Sterilisation method: no
- Lighting: no (aluminium foil)
- Is there any indication of the test material adsorbing to the walls of the test apparatus? no
TEST MEDIUM
- Volume used/treatment 250 mL
- Kind and purity of water: distilled water
- Preparation of test medium:
- Renewal of test solution:
OTHER TEST CONDITIONS
- Adjustment of pH: The actual pH value of each buffer was measured. The pH-meter calibrated to buffer solutions CertiPUR was used.
- Adjustment of temperature: The actual temperature of the thermostatic bath was controlled during the whole test every when the sampling was done. The calibrated thermometer was used and a temperature correction was taken into account via information from the calibration list. - Duration:
- 5 d
- pH:
- 4.1
- Temp.:
- 50 °C
- Initial conc. measured:
- ca. 1 g/L
- Duration:
- 5 d
- pH:
- 7
- Temp.:
- 50 °C
- Initial conc. measured:
- ca. 1 g/L
- Duration:
- 5 d
- pH:
- 8.8
- Temp.:
- 50 °C
- Initial conc. measured:
- ca. 1 g/L
- Number of replicates:
- 2
- Positive controls:
- no
- Negative controls:
- no
- Preliminary study:
- The preliminary test shows that less than 10 % of the test substance was hydrolysed within 5 days period at the pH 4.1, 7.0 and 8.8.
- Test performance:
- The half-life time of hydrolysis can therefore be expected grater than one year at 25°C and further testing was not required.
- Transformation products:
- no
- Key result
- pH:
- 4
- Temp.:
- 25 °C
- DT50:
- > 1 yr
- 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
- Anomalies or problems encountered (if yes): no
- Validity criteria fulfilled:
- yes
- Conclusions:
- The half-life times of hydrolysis at all tested pH (4, 7 and 9) and at 25°C were estimated as higher than 1 year.
- Executive summary:
The estimation is performed with respect to the results of preliminary test and with respect to the conclusion stated in the used methodology - Method C.7 – Degradation – Abiotic Degradation Hydrolysis as a Function of pH, Directive 92/69/EEC. Published in OJ No L 383A December 1992.
Results of preliminary test : pH = 4.1
Sampling |
Measurement |
Difference to time = 0 (%) |
|||
Time (days) |
Temperature (°C) |
No. |
Absorbance (AU) |
||
0 |
50.0 |
I |
A |
1.2706 |
|
B |
1.2702 |
||||
II |
A |
1.2631 |
|||
B |
1.2623 |
||||
Average |
1.267 |
0 |
|||
1.12 |
50.0 |
I |
A |
1.2316 |
|
B |
1.2314 |
||||
II |
A |
1.2335 |
|||
B |
1.2332 |
||||
Average |
1.232 |
-2.7 |
|||
3.92 |
50.0 |
I |
A |
1.2442 |
|
B |
1.2447 |
||||
II |
A |
1.2394 |
|||
B |
1.2373 |
||||
Average |
1.241 |
-2.0 |
|||
4.84 |
50.0 |
I |
A |
1.2525 |
|
B |
1.2516 |
||||
II |
A |
1.2583 |
|||
B |
1.2573 |
||||
Average |
1.255 |
-0.9 |
Results of preliminary test : pH = 7.0
Sampling |
Measurement |
Difference to time = 0 (%) |
|||
Time (days) |
Temperature (°C) |
No. |
Absorbance (AU) |
||
0 |
50.0 |
I |
A |
2.3560 |
|
B |
2.3574 |
||||
II |
A |
2.3695 |
|||
B |
2.3703 |
||||
Average |
2.363 |
0 |
|||
1.06 |
50.0 |
I |
A |
2.3661 |
|
B |
2.3662 |
||||
II |
A |
2.3565 |
|||
B |
2.3581 |
||||
Average |
2.362 |
-0.1 |
|||
3.90 |
50.0 |
I |
A |
2.3474 |
|
B |
2.3454 |
||||
II |
A |
2.3431 |
|||
B |
2.3411 |
||||
Average |
2.344 |
-0.8 |
|||
4.82 |
50.0 |
I |
A |
2.3669 |
|
B |
2.3731 |
||||
II |
A |
2.3828 |
|||
B |
2.3878 |
||||
Average |
2.378 |
0.6 |
Results of preliminary test : pH = 8.8
Sampling |
Measurement |
Difference to time = 0 (%) |
|||
Time (days) |
Temperature (°C) |
No. |
Absorbance (AU) |
||
0 |
50.0 |
I |
A |
2.5071 |
|
B |
2.5084 |
||||
II |
A |
2.5101 |
|||
B |
2.5096 |
||||
Average |
2.509 |
0 |
|||
1.07 |
50.0 |
I |
A |
2.5032 |
|
B |
2.5052 |
||||
II |
A |
2.5108 |
|||
B |
2.5074 |
||||
Average |
2.507 |
-0.1 |
|||
3.89 |
50.0 |
I |
A |
2.5216 |
|
B |
2.5205 |
||||
II |
A |
2.5499 |
|||
B |
2.5505 |
||||
Average |
2.536 |
1.1 |
|||
4.80 |
50.0 |
I |
A |
2.5102 |
|
B |
2.5134 |
||||
II |
A |
2.5073 |
|||
B |
2.5047 |
||||
Average |
2.509 |
0.0 |
Data source
Materials and methods
Results and discussion
Applicant's summary and conclusion
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.