Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
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: 208-341-9 | CAS number: 523-24-0
Hydrolysis
Administrative data
- Endpoint:
- hydrolysis
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- The study was conducted between 10 June 2005 and 11 August 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 111 (Hydrolysis as a Function of pH)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Diammonium phthalate
- EC Number:
- 208-341-9
- EC Name:
- Diammonium phthalate
- Cas Number:
- 523-24-0
- Molecular formula:
- C8H6O4.2H3N
- IUPAC Name:
- diammonium phthalate
- Test material form:
- solid: crystalline
Constituent 1
- Specific details on test material used for the study:
- Description: white crystalline solid
Lot number: 4172005
Date recieved: 02 June 2005
Storage conditions: room temperature, in the dark - Radiolabelling:
- no
Study design
- Analytical monitoring:
- yes
- Details on sampling:
- The sample solution vessels were taken from the water bath at various times and the pH of each sample recorded.
The concentration of the sample solution was determined by high performance liquid chromatography (HPLC). - Buffers:
- - pH: 4
- Composition of buffer:
Potassium hydrogen citrate: 1.00 x 10^-2 mol dm^-3
Sodium hydroxide: 1.80 x 10^-3 mol dm^-3
- pH: 7
- Composition of buffer:
Disodium hydrogen orthophosphate (anhydrous): 6.00 x 10^3 mol dm^-3
Potassium dihydrogen orthophosphate: 4.00 x 10^·3 mol dm^-3
Sodium chloride: 4.00 x 10^-3 mol dm^-3
- pH: 9
- Composition of buffer:
Disodium tetraborate: 2.00 x 10^-3 mol dm^-3
Sodium chloride: 4.00 x 10^-3 mol dm^-3
The buffer solutions were filtered through a 0.2 μm membrane filter to ensure they were sterile before commencement of the test. Also these solutions were subjected to ultrasonication and
degassing with nitrogen to minimise dissolved oxygen content. - Details on test conditions:
- Preparation of samples
Sample solutions were prepared in stoppered glass flasks at a nominal concentration of 2.0 g/l in the three buffer solutions. 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 at pH 4, 7 and 9 were maintained at 50.0 ± 0.5°C for a period of 5 days.
The phthalate component and the ammonium compnent were analysed separately
Duration of testopen allclose all
- Duration:
- 120 h
- pH:
- 4
- Temp.:
- 50 °C
- Initial conc. measured:
- 2 g/L
- Duration:
- 120 h
- pH:
- 7
- Temp.:
- 50 °C
- Initial conc. measured:
- 2 g/L
- Duration:
- 120 h
- pH:
- 9
- Temp.:
- 50 °C
- Initial conc. measured:
- 2 g/L
- Number of replicates:
- Duplicate aliquots of sample solution were analysed
- Positive controls:
- no
- Negative controls:
- no
Results and discussion
- Preliminary study:
- Phthalate component:
pH4: Less than 10% hydrolysis after 5 days at 50°C, equivalent to a half-life greater than 1 year at 25°C.
pH7: Less than 10% hydrolysis after 5 days at 50°C, equivalent to a half-life greater than 1 year at 25°C.
pH9: Less than 10% hydrolysis after 5 days at 50°C, equivalent to a half-life greater than 1 year at 25°C.
Ammonium component:
pH4: Less than 10% hydrolysis after 5 days at 50°C, equivalent to a half-life greater than 1 year at 25°C.
pH7: Less than 10% hydrolysis after 5 days at 50°C, equivalent to a half-life greater than 1 year at 25°C.
pH9: Less than 10% hydrolysis after 5 days at 50°C, equivalent to a half-life greater than 1 year at 25°C. - Transformation products:
- not measured
Total recovery of test substance (in %)open allclose all
- % Recovery:
- >= 98.5 - <= 99
- pH:
- 4
- Temp.:
- 50 °C
- Duration:
- 120 h
- Remarks on result:
- other: phthalate component
- % Recovery:
- >= 98.6 - <= 99.8
- pH:
- 7
- Temp.:
- 50 °C
- Duration:
- 120 h
- Remarks on result:
- other: phthalate component
- % Recovery:
- >= 99.2 - <= 101
- pH:
- 9
- Temp.:
- 50 °C
- Duration:
- 120 h
- Remarks on result:
- other: phthalate component
- % Recovery:
- >= 96.8 - <= 99.7
- pH:
- 4
- Temp.:
- 50 °C
- Duration:
- 120 h
- Remarks on result:
- other: ammonium component
- % Recovery:
- >= 97.1 - <= 97.5
- pH:
- 7
- Temp.:
- 50 °C
- Duration:
- 120 h
- Remarks on result:
- other: ammonium component
- % Recovery:
- >= 99 - <= 101
- pH:
- 9
- Temp.:
- 50 °C
- Duration:
- 120 h
- Remarks on result:
- other: ammonium component
Dissipation DT50 of parent compoundopen allclose all
- pH:
- 4
- Temp.:
- 25 °C
- DT50:
- > 1 yr
- Remarks on result:
- hydrolytically stable based on preliminary test
- pH:
- 7
- Temp.:
- 25 °C
- DT50:
- > 1 yr
- Remarks on result:
- hydrolytically stable based on preliminary test
- pH:
- 9
- Temp.:
- 25 °C
- DT50:
- > 1 yr
- Remarks on result:
- hydrolytically stable based on preliminary test
Any other information on results incl. tables
The phthalate component concentrations at the given time points are shown in the following tables:
pH 4 at 50.0 ± 0.5°C
|
Time (Hours) |
|||
0 A |
0 B |
120 A |
120 B |
|
Concentration (g/l) |
1.98 |
1.98 |
1.95 |
1.96 |
% of initial |
- |
- |
98.5 |
99.0 |
pH 7 at 50.0 ± 0.5°C
|
Time (Hours) |
|||
0 A |
0 B |
120 A |
120 B |
|
Concentration (g/l) |
2.00 |
1.98 |
1.99 |
1.96 |
% of initial |
- |
- |
99.8 |
98.6 |
pH 9 at 50.0 ± 0.5°C
|
Time (Hours) |
|||
0 A |
0 B |
120 A |
120 B |
|
Concentration (g/l) |
1.99 |
1.98 |
1.97 |
1.99 |
% of initial |
- |
- |
99.2 |
101 |
The ammonium component concentrations at the given time points are shown in the following tables:
pH 4 at 50.0 ± 0.5°C
|
Time (Hours) |
|||
0 A |
0 B |
120 A |
120 B |
|
Concentration (g/l) |
1.95 |
2.02 |
1.94 |
1.95 |
% of initial |
- |
- |
99.7 |
96.8 |
pH 7 at 50.0 ± 0.5°C
|
Time (Hours) |
|||
0 A |
0 B |
120 A |
120 B |
|
Concentration (g/l) |
2.00 |
2.00 |
1.94 |
1.95 |
% of initial |
- |
- |
97.1 |
97.5 |
pH 9 at 50.0 ± 0.5°C
|
Time (Hours) |
|||
0 A |
0 B |
120 A |
120 B |
|
Concentration (g/l) |
1.98 |
1.97 |
1.96 |
1.99 |
% of initial |
- |
- |
99.0 |
101 |
Validation
Linearities of the detector response with respect to concentration were assessed over the nominal concentration range of 0 to 200 mg/I. The results are as follows:
Component |
pH |
Correlation Coefficient |
phthalate |
4 |
1.000 |
phthalate |
7 |
1.000 |
phthalate |
9 |
1.000 |
ammonium |
4 |
1.000 |
ammonium |
7 |
1.000 |
ammonium |
9 |
1.000 |
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- The estimated half-lives at 25°C of the test material are as follows:
Component pH Estimated Half-life at 25°C
phthalate 4 > 1 year
phthalate 7 > 1 year
phthalate 9 > 1 year
ammonium 4 > 1 year
ammonium 7 > 1 year
ammonium 9 > 1 year - Executive summary:
Assessment of hydrolytic stability was carried out using Method 111 of the OECD Guidelines for Testing of Chemicals, 13 April 2004. The results are as follows:
Component pH Estimated Half-life at 25°C
phthalate 4 > 1 year
phthalate 7 > 1 year
phthalate 9 > 1 year
ammonium 4 > 1 year
ammonium 7 > 1 year
ammonium 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.
