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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
hydrolysis
Type of information:
experimental study
Adequacy of study:
key study
Study period:
23 Jun - 05 Jul 2021
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2021
Report date:
2021

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 111 (Hydrolysis as a Function of pH)
Version / remarks:
adopted April 13, 2004
Deviations:
yes
Remarks:
The temperature during the study (Tier 1) was maintained to 50 ± 0.6 °C instead of 50 ± 0.5 °C. It is not expected that this deviation revealed any effects on the study results.
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Radiolabelling:
no

Study design

Analytical monitoring:
yes
Details on sampling:
- Sampling intervals for the parent: pH 4, 7 and 9: at test start (0 h), after 3 h, 24 h and at the end of the test after 120 h.At each sampling point, samples were taken in duplicate (A and B).
- Sampling method: Aqueous samples were incubated and samples were taken at defined time points.
- Sampling intervals/times for pH measurements: The pH of the sample solution was determined at test start and at the end of the test at test temperature.
- Sampling intervals/times for sterility check: A sterility confirmation test was carried out at the end of the study.
- Sample storage conditions before analysis: Samples were diluted by a factor of 2 with acetonitrile to prevent further degradation of the test item after sampling.
Buffers:
Sterile aqueous solutions buffered at pH 4, 7 and 9.
The pH of each buffer solution was measured with a calibrated pH meter.
• pH 4: 0.05 M acetate buffer
410 mL acetic acid (0.1 M) was added to 90 mL sodium acetate (0.1 M). The solution was filled up to 1000 mL with pure water.
• pH 7: 0.05 M phosphate buffer
295 mL NaOH (0.1 M) was added to 500 mL potassium dihydrogenphosphate (0.1 M). The solution was filled up to 1000 mL with pure water.
• pH 9: 0.05 M borate buffer
212 mL NaOH (0.1 M) was added to 500 mL boric acid (0.1 M) in Potassium chloride (0.1 M). The solution was filled up to 1000 mL with pure water.
Details on test conditions:
TEST SYSTEM
- Type, material and volume of test flasks, other equipment used: Crimp cap glass vials (5 mL) sealed with PTFE lined crimp caps were used as test vessels.
- Sterilisation method: Degassed buffer solutions and the used glassware were sterilised using an autoclave (20 min at 121°C) prior to application.
- Lighting: darkness
- Measures taken to avoid photolytic effects: The samples were incubated in the dark.
- Measures to exclude oxygen: To avoid oxidation the buffer solutions were purged with inert gas (nitrogen) prior to sterilisation.
- If no traps were used, is the test system closed/open: closed
- Is there any indication of the test material adsorbing to the walls of the test apparatus?: No

TEST MEDIUM
- Volume used/treatment: The sample solutions were prepared with a volume of 50 mL and aliquots were transferred to the test vessels for incubation. Each replicate (A and B) was prepared individually.
- Preparation of test medium: Two individual stock solutions (A and B) were prepared in acetonitrile/pure water (30:70, v/v) with a concentration of 10 g/L. The final concentration of the test item in the aqueous phase was below 0.01 M or half of its water solubility.
Nominal Test item concentration: 300 mg/L
- Renewal of test solution: no
- Identity and concentration of co-solvent: Acetonitrile; the content of organic was < 1% v/v.

Blanks: Two blank samples for each pH were prepared consisting of the buffer solution (without application of the test item).

Duration of testopen allclose all
Duration:
120 h
pH:
4
Temp.:
50 °C
Initial conc. measured:
99.8 other: % of nominal
Duration:
120 h
pH:
7
Temp.:
50 °C
Initial conc. measured:
98.9 other: % of nominal
Duration:
120 h
pH:
9
Temp.:
50 °C
Initial conc. measured:
97.1 other: % of nominal
Number of replicates:
The following total number of samples was prepared: Preliminary Test (Tier 1): 8 per pH
Positive controls:
no
Negative controls:
no

Results and discussion

Preliminary study:
The present study investigated the hydrolytic behaviour of the test item in aqueous solutions buffered at pH 4, 7 and 9 and at one elevated temperature. Samples were incubated in the dark. The test was carried out for 5 days. At the end of incubation, 92-104% of the nominal applied concentration were found and thus the test item can be stated as hydrolytically stable (t0.5 > 1 year at 25°C).
Test performance:
Temperature: The temperature during the study (Tier 1) was maintained to 50 ± 0.6 °C.
pH-Value: Mean pH-values in the test samples at 50 °C were 4.1 (pH 4), 7.0
(pH 7) and 8.8 (pH 9). The pH was controlled at test start and at the end of the test.
Sterility of the Test Solution: Sterility was confirmed. No colonies were observed.
Transformation products:
no
Remarks:
not determined, as hydrolytically stable in pre-test
Total recovery of test substance (in %)open allclose all
% Recovery:
101.3
pH:
4
Temp.:
50 °C
Duration:
120 d
Remarks on result:
hydrolytically stable based on preliminary test
% Recovery:
103.6
pH:
7
Temp.:
50 °C
Duration:
120 h
Remarks on result:
hydrolytically stable based on preliminary test
% Recovery:
97.1
pH:
9
Temp.:
50 °C
Duration:
120 h
Remarks on result:
hydrolytically stable based on preliminary test
Dissipation DT50 of parent compoundopen allclose all
Key result
pH:
9
Temp.:
50 °C
Remarks on result:
other: the preliminary study indicates that the substance is hydrolytically stable and no further study was performed
Key result
pH:
7
Temp.:
50 °C
Remarks on result:
other: the preliminary study indicates that the substance is hydrolytically stable and no further study was performed
Key result
pH:
4
Temp.:
50 °C
Remarks on result:
other: the preliminary study indicates that the substance is hydrolytically stable and no further study was performed
Details on results:
TEST CONDITIONS
- Mean pH-values in the test samples at 50 °C were 4.1 (pH 4), 7.0 (pH 7) and 8.8 (pH 9). The pH was controlled at test start and at the end of the test.
- sterility was maintained throughout the study
- The temperature during the study (Tier 1) was maintained to 50 ± 0.6 °C.
- no anomalies or problems encountered

MAJOR TRANSFORMATION PRODUCTS: None

MINOR TRANSFORMATION PRODUCTS: None

MINERALISATION: None

Any other information on results incl. tables

Immediately after application (0 h) recoveries of the samples were as follows:



  • Preliminary test (Tier 1): 96.9-100.0% of the nominal applied concentration.


Recoveries of the applied concentration were considered acceptable for the preliminary test (Tier 1). Result evaluation was performed based on the nominal concentration.

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Remarks:
see above
Conclusions:
The present study investigated the hydrolytic behaviour of the test item in aqueous solutions buffered at
pH 4, 7 and 9 and at one elevated temperature. Samples were incubated in the dark. The test was carried out for 5 days. At the end of incubation, 92-104% of the nominal applied concentration were found and thus the test item can be stated as hydrolytically stable (t0.5 > 1 year at 25 °C).
Executive summary:

Test Design: Crimp cap glass vials (5 mL) sealed with PTFE lined crimp caps were used as test vessels.Sterile aqueous solutions buffered at pH 4, 7 and 9.


Test Conditions: In the dark at 50°C, the temperature during the study (Tier 1) was maintained to 50 ± 0.6 °C.


Treatment Rate: Preliminary test (Tier 1): 300 mg/L


Results: The present study investigated the hydrolytic behaviour of the test item in aqueous solutions buffered at pH 4, 7 and 9 and at one elevated temperature. Samples were incubated in the dark. The test was carried out for 5 days. At the end of incubation, 92-104% of the nominal applied concentration were found and thus the test item can be stated as hydrolytically stable (t0.5 > 1 year at 25 °C).