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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:
11th December 2018 to 19th December 2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2019
Report date:
2019

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: The Guidelines for the Testing of Chemicals No. 111 'Hydrolysis as a function of pH (MEP, 2013|)
GLP compliance:
yes

Test material

Study design

Analytical monitoring:
yes
Buffers:
- pH: 4.0, 7.0 and 9.0

- Composition of buffers:
pH 4.0 - 500ml of 0.1 mol/L Potassium Dihydrogen Citrate + 90ml 0.1 mol/L of NaOH, made up to 1000ml with pure water
pH 7.0 - 500ml of 0.1 mol/L KH2PO4 + 296.3 of 0.1 mol/L of NaOH, made up to 1000ml with pure water
pH 9.0 - 500ml of 0.1 mol/L Boracic Acid(dissolved in 0.1 mol/L KCl + 213ml 0.1 mol/L of NaOH, made up to 1000ml with pure water

All buffer solutions and glassware were sterilised for 20mins at 121oC.
Details on test conditions:
500μL of stock solution of 400mg/L was added to 100ml of the buffer solutions of pH 4.0, 7.0 and 9.0 to generate a test solution of 20mg/L. The solutions were divided in 3 and placed at 50± 0.5oC in the dark. The residual concentration was measured on Day 5
Duration of testopen allclose all
Duration:
5 d
pH:
9
Temp.:
50 °C
Initial conc. measured:
18.3 mg/L
Duration:
5 d
pH:
7
Temp.:
50 °C
Initial conc. measured:
21 mg/L
Duration:
5 d
pH:
4
Temp.:
50 °C
Initial conc. measured:
20.6 mg/L
Number of replicates:
Three
Positive controls:
no
Negative controls:
no

Results and discussion

Preliminary study:
The average initial concentrations of pH 4, 7 and 9 were 20.6, 21.0 and 18.3 mg/L respectively. The residual concentration of pH 4, 7 and 9 on Day 5 were 19.0, 20.2 and 19.5 mg/L respectively. Therefore, the hydrolysis rates of pH 4, 7 and 9 on Day 5 were 7.8%, 1.7% and 5.4% respectively.
The hydrolysis rate at pH 4.0, 7.0 and 9.0 were all less than 10% on the 5th day at 50oC ± 0.5oC so the definitive test was terminated. 
Transformation products:
no
Dissipation DT50 of parent compoundopen allclose all
Key result
pH:
4
Temp.:
50 °C
Remarks on result:
hydrolytically stable based on preliminary test
Key result
pH:
7
Temp.:
50 °C
Remarks on result:
hydrolytically stable based on preliminary test
Key result
pH:
9
Temp.:
50 °C
Remarks on result:
hydrolytically stable based on preliminary test
Details on results:
The hydrolysis rate at pH 4.0, 7.0 and 9.0 were all less than 10% on the 5th day at 50oC ± 0.5oC so the definitive test was terminated. 

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
The test item E Stage 3 Intermediate is hydrolytically stable. The DT50 cannot be calculated but is estimated to be >1 year at 2.5oC based on Test Guideline MEP 111. 
Executive summary:

HPLC was employed to determine the Test Item E Stage 3 Intermediate. The recovery test in buffer solution used two concentrations, 2mg/L and 50 mg/L. The mean recovery rate was in the range 87.8- 106.1% with RSD in the range of 0.6 -4.4%. The analytical method used met the quality criteria. The hydrolysis rate at pH 4.0, 7.0 and 9.0 were all less than 10% on the 5th day at 50oC ± 0.5oC so the definitive test was terminated. 


The test item E Stage 3 Intermediate is hydrolytically stable. The DT50 cannot be calculated but is estimated to be >1 year at 2.5oC based on Test Guideline MEP 111.