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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
hydrolysis
Type of information:
experimental study
Adequacy of study:
key study
Study period:
31st March 2007 to 1st May 2007
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:
2007
Report date:
2007

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 111 (Hydrolysis as a Function of pH)
Deviations:
no
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)
Remarks:
Date of inspection; 30th August 2005 Date of inspection: 21st November 2005

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Sponsor's identification :C-C1
Description : dark blue powder
Lot number : MB-1
Date received : 05 March 2007
Storage conditions :room temperature in the dark, over silica gel
Radiolabelling:
no

Study design

Analytical monitoring:
yes
Details on sampling:
Preparation of samples
Sample solutions were prepared in stoppered glass flasks at a nominal concentration of 1 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, pH 7 and pH 9 were maintained at 50.0 ± 0.5°C for a period of 5 days

Analysis of sample solutions
The sample solutions were taken from the waterbath at various times and the pH of each solution recorded.
The concentration of the sample solution was determined by high performance liquid chromatography (HPLC).
Samples
Duplicate aliquots (A and B) of sample solution were diluted by a factor of 4 using reverse osmosis water.
Standards
Duplicate standard solutions of test material were prepared in reverse osmosis water:buffer (3:1) at a nominal concentration of 250 mg/l.
Analysis

Buffers:
Specification of buffer solutions

(pH) Components Concentration
(mol dm-3)
4 Potassium hydrogen phthalate 0.01
7 Disodium hydrogen orthophosphate (anhydrous) 0.006
Potassium dihydrogen orthophosphate 0.004
Sodium chloride 0.004
9 Disodium tetraborate 0.002
Sodium chloride 0.004
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:
TEST SYSTEM
- Type, material and volume of test flasks, other equipment used: not stated in report

Preliminary test
Sample solutions at pH 4, pH 7 and pH 9 were maintained at 50.0 ± 0.5°C for a period of 5 days.

The buffer solutions were filtered through a 0.2 µm membrane filter to ensure they were sterile before commencement of the test.

The linearity of the detector response with respect to concentration was assessed over the nominal concentration range of 0 to 508 mg/l. This was satisfactory with a correlation coefficient of 1.00 being obtained.
Duration of testopen allclose all
Duration:
5 d
pH:
9
Initial conc. measured:
0.999 g/L
Duration:
5 d
pH:
9
Initial conc. measured:
1 g/L
Duration:
5 d
pH:
7
Initial conc. measured:
1 g/L
Duration:
5 d
pH:
7
Initial conc. measured:
1.01 g/L
Duration:
5 d
pH:
4
Initial conc. measured:
0.979 g/L
Duration:
5 d
pH:
4
Initial conc. measured:
0.975 g/L
Positive controls:
no
Negative controls:
no
Statistical methods:
None

Results and discussion

Preliminary study:
Not applicable
Test performance:
The linearity of the detector response with respect to concentration was assessed over the nominal concentration range of 0 to 508 mg/l. This was satisfactory with a correlation coefficient of 1.00 being obtained.
Transformation products:
no
Details on hydrolysis and appearance of transformation product(s):
Not applicable
Total recovery of test substance (in %)open allclose all
% Recovery:
97.9
pH:
4
Temp.:
50 °C
Duration:
5 d
% Recovery:
98.5
pH:
4
Temp.:
50 °C
Duration:
5 d
% Recovery:
98.4
pH:
7
Temp.:
50 °C
Duration:
5 d
% Recovery:
98.9
pH:
7
Temp.:
50 °C
Duration:
5 d
% Recovery:
101
pH:
9
Temp.:
50 °C
Duration:
5 d
% Recovery:
100
pH:
9
Temp.:
50 °C
Duration:
5 d
Dissipation DT50 of parent compoundopen allclose all
pH:
4
Temp.:
50 °C
DT50:
> 8 760 h
pH:
7
Temp.:
50 °C
DT50:
> 8 760 h
pH:
9
Temp.:
50 °C
DT50:
> 8 760 h
Details on results:
pH 4: Less than 10% hydrolysis after 5 days at 50°C, equivalent to a half-life greater than 1 year at 25°C.

pH 7: Less than 10% hydrolysis after 5 days at 50°C, equivalent to a half-life greater than 1 year at 25°C.

pH 9: Less than 10% hydrolysis after 5 days at 50°C, equivalent to a half-life greater than 1 year at 25°C.

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Remarks:
The linearity of the detector response with respect to concentration was assessed over the nominal concentration range of 0 to 508 mg/l. This was satisfactory with a correlation coefficient of 1.00 being obtained.
Conclusions:
The estimated half-life at 25°C of the test material for pH 4, pH 7 and pH 9 has been shown to be >1 year.
Executive summary:

The determination was carried out using Method C7 of Commission Directive 92/69/EEC and Method 111 of the OECD Guidelines for Testing of Chemicals, 13 April 2004.

The estimated half-life at 25°C of the test material for pH 4, pH 7 and pH 9 has been shown to be >1 year.