Registration Dossier
Registration Dossier
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: - | 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:
- 08 January 2009 to 26 February 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.7 (Degradation: Abiotic Degradation: Hydrolysis as a Function of pH)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Date of inspection: 19 August 2008; Date of signature: 04 March 2009
Test material
- Radiolabelling:
- no
Study design
- Analytical monitoring:
- yes
Duration of testopen allclose all
- Duration:
- 120 h
- pH:
- 4
- Temp.:
- 50 °C
- Initial conc. measured:
- 0.515 g/L
- Duration:
- 120 h
- pH:
- 4
- Temp.:
- 50 °C
- Initial conc. measured:
- 0.514 g/L
- Duration:
- 120 h
- pH:
- 7
- Temp.:
- 50 °C
- Initial conc. measured:
- 0.511 g/L
- Duration:
- 120 h
- pH:
- 7
- Temp.:
- 50 °C
- Initial conc. measured:
- 0.513 g/L
- Duration:
- 120 h
- pH:
- 9
- Temp.:
- 50 °C
- Initial conc. measured:
- 0.502 g/L
- Duration:
- 120 h
- pH:
- 9
- Temp.:
- 50 °C
- Initial conc. measured:
- 0.501 g/L
Results and discussion
- Transformation products:
- not specified
Dissipation DT50 of parent compoundopen allclose all
- pH:
- 4
- Temp.:
- 25 °C
- DT50:
- > 1 yr
- pH:
- 7
- Temp.:
- 25 °C
- DT50:
- > 1 yr
- pH:
- 9
- Temp.:
- 25 °C
- DT50:
- > 1 yr
Any other information on results incl. tables
Preliminary test/Tier 1
The mean peak areas relating to the standard and sample solutions are shown in the following table:
Table 2
Solution |
Mean peak area |
Standard 487 mg/l |
1.237 x 104 |
Standard 505 mg/l |
1.291 x 104 |
Initial Sample A, pH 4 |
1.316 x 104 |
Initial Sample B, pH 4 |
1.317 x 104 |
Standard 563 mg/l |
1.420 x 104 |
Standard 530 mg/l |
1.341 x 104 |
69 Hour Sample A, pH 4 |
1.309 x 104 |
69 Hour Sample B, pH 4 |
1.309 x 104 |
Standard 568 mg/l |
1.436 x 104 |
Standard 560 mg/l |
1.436 x 104 |
120 Hour Sample A, pH 4 |
1.312 x 104 |
120 Hour Sample B, pH 4 |
1.308 x 104 |
Standard 578 mg/l |
1.490 x 104 |
Standard 551 mg/l |
1.420 x 104 |
Initial Sample A, pH 7 |
1.315 x 104 |
Initial Sample B, pH 7 |
1.319 x 104 |
Standard 493 mg/l |
1.308 x 104 |
Standard 513 mg/l |
1.331 x 104 |
69 Hour Sample A, pH 7 |
1.303 x 104 |
69 Hour Sample B, pH 7 |
1.299 x 104 |
Standard 554 mg/l |
1.403 x 104 |
Standard 551 mg/l |
1.419 x 104 |
120 Hour Sample A, pH 7 |
1.306 x 104 |
120 Hour Sample B, pH 7 |
1.310 x 104 |
Solution |
Mean peak area |
Standard 538 mg/l |
1.377 x 104 |
Standard 542 mg/l |
1.387 x 104 |
Initial Sample A, pH 9 |
1.361 x 104 |
Initial Sample B, pH 9 |
1.365 x 104 |
Standard 516 mg/l |
1.261 x 104 |
Standard 524 mg/l |
1.315 x 104 |
69 Hour Sample A, pH 9 |
1.284 x 104 |
69 Hour Sample B, pH 9 |
1.292 x 104 |
Standard 553 mg/l |
1.417 x 104 |
Standard 532 mg/l |
1.375 x 104 |
120 Hour Sample A, pH 9 |
1.291 x 104 |
120 Hour Sample B, pH 9 |
1.291 x 104 |
The test material concentrations at the given time points are shown in the following tables:
Table 3 pH 4 at 50.0 ± 0.5ºC
Time (Hours) |
Concentration (g/l) |
Log10[concentration (g/l)] |
% of mean initial concentration |
|||
A |
B |
A |
B |
A |
B |
|
0 |
0.517 |
0.517 |
-0.287 |
-0.286 |
99.9 |
100 |
69 |
0.518 |
0.518 |
-0.285 |
-0.285 |
100 |
100 |
120 |
0.515 |
0.514 |
-0.288 |
-0.289 |
99.7 |
99.4 |
Result: Less than 10% hydrolysis after 5 days at 50°C, equivalent to a half-life greater than 1 year at 25°C.
Table 4 pH 7 at 50.0 ± 0.5ºC
Time (Hours) |
Concentration (g/l) |
Log10[concentration (g/l)] |
% of mean initial concentration |
|||
A |
B |
A |
B |
A |
B |
|
0 |
0.510 |
0.512 |
-0.292 |
-0.291 |
99.9 |
100 |
69 |
0.497 |
0.495 |
-0.304 |
-0.305 |
97.2 |
96.9 |
120 |
0.511 |
0.513 |
-0.291 |
-0.290 |
100 |
100 |
Result: Less than 10% hydrolysis after 5 days at 50°C, equivalent to a half-life greater than 1 year at 25°C.
Table 5 pH 9 at 50.0 ± 0.5ºC
Time (Hours) |
Concentration (g/l) |
Log10[concentration (g/l)] |
% of mean initial concentration |
|||
A |
B |
A |
B |
A |
B |
|
0 |
0.532 |
0.533 |
-0.274 |
-0.273 |
99.8 |
100 |
69 |
0.518 |
0.522 |
-0.285 |
-0.283 |
97.4 |
98.0 |
120 |
0.502 |
0.501 |
-0.300 |
-0.300 |
94.3 |
94.2 |
Result: Less than 10% hydrolysis after 5 days at 50°C, equivalent to a half-life greater than 1 year at 25°C.
Validation
The linearity of the detector response with respect to concentration was assessed over the nominal concentration range of 0 to 1.00 x 103 mg/l for each matrix. These were satisfactory with correlation coefficients of ≥ 0.999 being obtained.
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- The estimated half-lives at 25°C of the test material at pH 4, pH7 and pH9 was shown to be >1 year.
- Executive summary:
Assessment of hydrolytic stability was carried out using Method C7 Abiotic Degradation, Hydrolysis as a Function of pH of Commission Regulation (EC) No 440/2008 of 30 May 2008.
The results are as follows:
pH
Estimated half-life at 25°C
4
>1 year
7
>1 year
9
>1 year
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.
