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EC number: 452-330-3 | 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:
- 26 August 2003 to 03 September 2003
- 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
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 111 (Hydrolysis as a Function of pH)
- Deviations:
- no
- GLP compliance:
- yes
- Radiolabelling:
- no
- Analytical monitoring:
- yes
- Details on sampling:
- - Sampling intervals for the parent/transformation products: 2.4 hours, 2 days and 5 days. After an initial period of about 1 hour, to ensure that the test item had completely dissolved in the buffer solution and that the solutions were at test temperature, the first aliquot for analysis was removed and the concentration of the test material determined by high performance liquid chromatography. This aliquot was designated t0.
- Sampling intervals/times for pH measurements: pH was measured with the final aliquot taken for analysis
- Sample preparation: 2.0 mL from the hydrolysis solution were diluted with the mobile phase to reach concentrations within those of the reference solutions. - Buffers:
- - pH: 4.0
- Type of buffer: citrate buffer
- Composition and final molarity of buffer: 20 mM sodium citrate
- pH: 7.0
- Type of buffer: phosphate buffer
- Composition and final molarity of buffer: 20 mM sodium phosphate
- pH: 9.0
- Type of buffer: borax buffer
- Composition and final molarity of buffer: 20 mM sodium tetraborate
The buffer solutions were prepared under clean room conditions, filtered through a 0.2 µm membrane filter and were sterile. - Details on test conditions:
- TEST SYSTEM
- Type, material and volume of test flasks, other equipment used: amber 100 mL volumetric flasks.
- Measures taken to avoid photolytic effects: To exclude light from the test system, the water bath was covered in aluminium foil. As a further precautionary measure, amber volumetric flasks were used. This gave protection during the times that flasks were exposed to light, such as sampling.
TEST MEDIUM
- Preparation of test medium: Approximately 40 mg of the test material were accurately weighed into six individual flasks. Approximately 100 ml of the appropriate sterile buffer solution were added to the flasks. The flasks were then placed in a thermostatically controlled water bath at 50 °C ± 0.1 °C with continuous stirring.
OTHER TEST CONDITIONS
- Dissolved oxygen: Dissolved oxygen was removed from the system by bubbling a stream of argon gas through each solution for approximately five minutes - Duration:
- 5 d
- pH:
- 3.8
- Temp.:
- 50 °C
- Initial conc. measured:
- 420.715 - 445.881 mg/L
- Duration:
- 5 d
- pH:
- 7.1
- Temp.:
- 50 °C
- Initial conc. measured:
- 402.279 - 447.261 mg/L
- Duration:
- 5 d
- pH:
- 9.1
- Temp.:
- 50 °C
- Initial conc. measured:
- 433.56 - 468.756 mg/L
- Number of replicates:
- Two per pH tested
- Positive controls:
- no
- Negative controls:
- no
- Test performance:
- The results indicated that less than 10 % of the test item had hydrolysed at any pH value after the five days at 50 °C, including the pH 9.0 buffer solution, in which slight decomposition had occurred. According to the standardised guidelines followed, when less than 10 % of the the test substance has hydrolysed after five days at 50 °C, then no further testing is required.
- Transformation products:
- not measured
- pH:
- 3.8
- Temp.:
- 50 °C
- DT50:
- > 1 yr
- pH:
- 7.1
- Temp.:
- 50 °C
- DT50:
- > 1 yr
- pH:
- 9.1
- Temp.:
- 50 °C
- DT50:
- > 1 yr
- Details on results:
- TEST CONDITIONS
- pH, sterility, temperature, and other experimental conditions maintained throughout the study: Yes - Validity criteria fulfilled:
- yes
- Remarks:
- The study meets that quality criteria as defined in standardised guidelines.
- Conclusions:
- Under the conditions of the test, the half-life of the test material (t1/2) was estimated from the preliminary test as greater than 1 year at pH 3.8, 7.1 and 9.1 at 25 °C. The study is considered to be reliable, relevant and adequate for risk assessment purposes.
- Executive summary:
The rate of hydrolysis of the test material was determined at three pH values in accordance with the standardised guidelines OECD 111 and EU Method C.7. After five days at 50 °C less than 10 % of the test item had hydrolysed at any of the three investigated pH values. Therefore, in accordance with the test method used, the half-life time t1/2 of the test material may be estimated from the preliminary test to be:
t1/2 >1 year at 25 °C and pH 3.8
t1/2 >1 year at 25 °C and pH 7.1
t1/2 >1 year at 25 °C and pH 9.1
Reference
Table 1: Results
Hydrolysis solution | H41 | H42 | H71 |
H72 | H91 | H92 |
Concentration [mg/L] at time t0 | ||||||
1st determination | 447.135 | 419.773 | 401.936 | 445.625 | 465.409 | 433.390 |
2nd determination | 444.627 | 421.656 | 402.622 | 448.896 | 472.102 | 433.729 |
Average | 445.881 | 420.715 | 402.279 | 447.261 | 468.756 | 433.560 |
Concentration [mg/L] at time2.4h | ||||||
1st determination | 456.540 | 420.041 | 406.222 | 443.133 | 452.910 | 416.380 |
2nd determination | 455.822 | 426.099 | 411.730 | 440.056 | 457.506 | 415.315 |
Average | 456.181 | 423.070 | 408.976 | 441.595 | 455.208 | 415.848 |
Concentration change [%] | 2.310 | 0.560 | 1.665 | -1.267 | -2.890 | -4.085 |
Average concentration change | 1.4 | 0.2 | -3.5 | |||
Concentration [mg/L] at time2d | ||||||
1st determination | 456.093 | 424.568 | 398.527 | 438.195 | 436.242 | 402.160 |
2nd determination | 436.910 | 410.195 | 397.879 | 437.685 | 435.728 | 396.732 |
Average | 446.502 | 417.382 | 398.203 | 437.940 | 435.985 | 399.446 |
Concentration change [%] | 0.139 | -0.792 | -1.013 | -2.084 | -6.991 | -7.868 |
Average concentration change | -0.3 | -1.5 | -7.4 | |||
Concentration [mg/L] at t5d | ||||||
1st determination | 445.369 | 408.433 | 390.359 | 418.098 | 432.500 | 400.701 |
2nd determination | 446.657 | 412.456 | 393.426 | 420.264 | 429.606 | 400.456 |
Concentration change [%] | 0.030 | -2.441 | -2.582 | -6.278 | -8.043 | -7.607 |
Average concentration change | -1.2 | -4.4 | -7.8 | |||
pH at 50 ºC | 3.81 | 3.81 | 7.09 | 7.10 | 9.14 | 9.12 |
Average pH | 3.8 | 7.1 | 9.1 |
Description of key information
Hydrolysis Half-life >1 year, pH 3.8, 7.1 and 9.1, 25 ºC, OECD 111, EU Method C.7, Das 2003
Key value for chemical safety assessment
Additional information
The rate of hydrolysis of the test material was determined at three pH values in accordance with the standardised guidelines OECD 111 and EU Method C.7. After five days at 50 °C less than 10% of the test item had hydrolysed at any of the three investigated pH values. Therefore, in accordance with the test method used, the half-life time t1/2of the test material may be estimated from the preliminary test to be:
t1/2>1 year at 25 °C and pH 3.8
t1/2>1 year at 25 °C and pH 7.1
t1/2>1 year at 25 °C and pH 9.1
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